,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342837,Effect of Mass Treatment with Azithromycin on Causes of Death in Children in Malawi: Secondary Analysis from the MORDOR Trial.,"Recent evidence indicates mass drug administration with azithromycin may reduce child mortality. This study uses verbal autopsy (VA) to investigate the causes of individual deaths during the Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial in Malawi. Cluster randomization was performed as part of MORDOR. Biannual household visits were conducted to distribute azithromycin or placebo to children aged 1-59 months and update the census to identify deaths for VA. MORDOR was not powered to investigate mortality effects at individual sites, but the available evidence is presented here for hypothesis generation regarding the mechanism through which azithromycin may reduce child mortality. Automated VA analysis was performed to infer the likely cause of death using two major analysis programs, InterVA and SmartVA. A total of 334 communities were randomized to azithromycin or placebo, with more than 130,000 person-years of follow-up. During the study, there were 1,184 deaths, of which 1,131 were followed up with VA. Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20). The intention-to-treat analysis by cause using InterVA suggested fewer HIV/AIDS deaths in azithromycin-treated communities (rate ratio 0.70 [95% CI: 0.50-0.97];  P  = 0.03) and fewer pneumonia deaths (rate ratio 0.82 [95% CI: 0.60-1.12];  P  = 0.22). The use of the SmartVA algorithm suggested fewer diarrhea deaths (rate ratio 0.71 [95% CI: 0.51-1.00];  P  = 0.05) and fewer pneumonia deaths (rate ratio 0.58 [95% CI: 0.33-1.00];  P  = 0.05). Although this study is not able to provide strong evidence, the data suggest that the mortality reduction during MORDOR in Malawi may have been due to effects on pneumonia and diarrhea or HIV/AIDS mortality.",2020,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"['A total of 334 communities', 'Children in Malawi']","['azithromycin', 'Azithromycin', 'azithromycin or placebo']","['child mortality', 'pneumonia deaths', 'Causes of Death', 'Mortality', 'diarrhea deaths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",334.0,0.538584,Mortality was 9% lower in azithromycin-treated communities than in placebo communities (rate ratio 0.91 [95% CI: 0.79-1.05];  P  = 0.20).,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0613']
1,32342840,Cost-Effectiveness of Mass Treatment with Azithromycin for Reducing Child Mortality in Malawi: Secondary Analysis from the MORDOR Trial.,"The recent Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin mass drug administration (MDA). Here, we investigate the financial costs and cost-effectiveness from the health provider perspective of azithromycin MDA at the MORDOR-Malawi study site. During MORDOR, a cluster-randomized trial involving biannual azithromycin MDA or placebo to children aged 1-59 months, fieldwork-related costs were collected, including personnel, transport, consumables, overheads, training, and supervision. Mortality rates in azithromycin- and placebo-treated clusters were calculated overall and for the five health zones of Mangochi district. These were used to estimate the number needed to treat to avert one death and the costs per death and disability-adjusted life year (DALY) averted. The cost per dose of MDA was $0.74 overall, varying between $0.63 and $0.94 in the five zones. Overall, the number needed to treat to avert one death was 1,213 children; the cost per death averted was $898.47, and the cost per DALY averted was $9.98. In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows: 3,070, $2,899.24, and $32.31 in Monkey Bay zone; 1,530, $1,214.42, and $13.49 in Chilipa zone; and 344, $217.98, and $2.42 in Namwera zone. This study is a preliminary cost-effectiveness analysis that indicates azithromycin MDA for reducing child mortality has the potential to be highly cost-effective in some settings in Malawi, but the reasons for geographical variation in effectiveness require further investigation.",2020,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:",['Malawi'],"['biannual azithromycin MDA or placebo', 'azithromycin- and placebo', 'Azithromycin', 'azithromycin MDA', 'azithromycin']","['cost per death averted', 'child mortality', 'cost per dose of MDA', 'Child Mortality', 'financial costs and cost-effectiveness', 'mortality', 'Mortality rates']","[{'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0794041,"In the three zones where mortality was lower in azithromycin-treated clusters, the number needed to treat to avert one death, cost per death averted, and cost per DALY averted, respectively, were as follows:","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, Califorina.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0622']
2,32342841,Effects of Biannual Azithromycin Mass Drug Administration on Malaria in Malawian Children: A Cluster-Randomized Trial.,"Reductions in malaria morbidity have been reported following azithromycin mass drug administration (MDA) for trachoma. The recent Macrolides Oraux pour Reduire les Deces avec un Oeil sur la Resistance (MORDOR) trial reported a reduction in child mortality following biannual azithromycin MDA. Here, we investigate the effects of azithromycin MDA on malaria at the MORDOR-Malawi study site. A cluster-randomized double-blind placebo-controlled trial, with 15 clusters per arm, was conducted. House-to-house census was updated biannually, and azithromycin or placebo syrup was distributed to children aged 1-59 months for a total of four biannual distributions. At baseline, 12-month, and 24-month follow-up visits, a random sample of 1,200 children was assessed for malaria with thick and thin blood smears and hemoglobin measurement. In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities; 95% CI: -2.8 to 1.5), or anemia (1.7% lower in azithromycin-treated communities; 95% CI: -8.1 to 4.6) between placebo and azithromycin communities. Further interrogation of the data at the individual level, both per-protocol (including only those who received treatment 6 months previously) and by intention-to-treat, did not identify differences in parasitemia between treatment arms. In contrast to several previous reports, this study did not show an effect of azithromycin MDA on malaria parasitemia at the community or individual levels.",2020,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities",['Malaria in Malawian Children'],"['azithromycin or placebo syrup', 'azithromycin MDA', 'azithromycin', 'Biannual Azithromycin Mass Drug Administration', 'azithromycin-treated communities', 'placebo']","['child mortality', 'malaria parasitemia', 'anemia', 'prevalence of parasitemia', 'gametocytemia', 'malaria morbidity', 'malaria with thick and thin blood smears and hemoglobin measurement']","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008083', 'cui_str': 'Mortality, Child'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",1200.0,0.469202,"In the community-level analysis, there was no difference in the prevalence of parasitemia (1.0% lower in azithromycin-treated communities; 95% CI: -8.2 to 6.1), gametocytemia (0.7% lower in azithromycin-treated communities","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Hart', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Lyson', 'Initials': 'L', 'LastName': 'Samikwa', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Feston', 'Initials': 'F', 'LastName': 'Sikina', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach, Blantyre, Malawi.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation and Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Burr', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0619']
3,32343288,Examining the characteristics of patients who continue participation in vs those who drop out of a PTSD clinical trial,"BACKGROUND


Patients who drop out of clinical trials examining posttraumatic stress disorder (PTSD) may have different characteristics than patients who continue. These characteristics have never been examined in prior PTSD and attrition trials. Our goal was to examine how demographic and clinical characteristics of patients with PTSD impact attrition in a randomized controlled trial.
METHODS


A total of 18 participants were recruited. Data were collected through questionnaires to assess PTSD, depression, and mood disorders. Fisher’s exact test was used to examine the association of various categorical demographic and clinical variables with dropout. A Wilcoxon rank sum test was used to examine differences in medians.
RESULTS


The median total PTSD Checklist for DSM-5 score was 38 for patients who dropped out and 53 for those who did not. The depression scale total was also lower for the dropout group (7 vs 15). The insomnia index was lower for those who did not remain in the study (15 vs 21).
CONCLUSIONS


Posttraumatic stress disorder symptoms, depression, and insomnia were less severe in patients who dropped out compared with those who did not. Larger studies are needed to further examine these findings. This study could help guide future recruitment efforts for clinical trials examining PTSD.",2020,The depression scale total was also lower for the dropout group (7 vs 15).,"['patients with PTSD impact attrition', 'A total of 18 participants were recruited', 'Patients who drop out of clinical trials examining posttraumatic stress disorder (PTSD', 'patients who continue participation in vs those who drop out of a PTSD clinical trial']",[],"['insomnia index', 'PTSD, depression, and mood disorders', 'depression scale total', 'median total PTSD Checklist for DSM-5 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",[],"[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0712566,The depression scale total was also lower for the dropout group (7 vs 15).,"[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Ponkshe', 'Affiliation': ''}, {'ForeName': 'Angelia', 'Initials': 'A', 'LastName': 'Holland-Winkler', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': ''}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
4,32276071,Acute alcohol intoxication and expectations reshape the spatiotemporal functional architecture of executive control.,"While the deleterious effects of acute ethyl alcohol intoxication on executive control are well-established, the underlying spatiotemporal brain mechanisms remain largely unresolved. In addition, since the effects of alcohol are noticeable to participants, isolating the effects of the substance from those related to expectations represents a major challenge. We addressed these issues using a double-blind, randomized, parallel, placebo-controlled experimental design comparing the behavioral and electrical neuroimaging acute effects of 0.6 vs 0.02 ​g/kg alcohol intake recorded in 65 healthy adults during an inhibitory control Go/NoGo task. Topographic ERP analyses of covariance with self-reported dose expectations allowed to dissociate their neurophysiological effects from those of the substance. While alcohol intoxication increased response time variability and post-error slowing, bayesian analyses indicated that it did not modify commission error rates. Functionally, alcohol induced topographic ERP modulations over the periods of the stimulus-locked N2 and P3 components, arising from pre-supplementary motor and anterior cingulate areas. In contrast, alcohol decreased the strength of the response-locked anterior cingulate error-related component but not its topography. This pattern indicates that alcohol had a locally specific influence within the executive control network, but disrupted performance monitoring processes via global strength-based mechanisms. We further revealed that alcohol-related expectations induced temporally specific functional modulations of the early N2 stimulus-locked medio-lateral prefrontal activity, a processing phase preceding those influenced by the actual alcohol intake. Our collective findings thus not only reveal the mechanisms underlying alcohol-induced impairments in impulse control and error processing, but also dissociate substance- from expectations- related functional effects.",2020,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.",['65 healthy adults during an inhibitory control Go/NoGo task'],['placebo'],['strength of the response-locked anterior cingulate error'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",65.0,0.0365488,"Functionally, alcohol induced topographic modulation over the periods of the stimulus-locked N2 and P3 event-related potential components, arising from pre- supplementary motor and anterior cingulate areas.","[{'ForeName': 'Farfalla', 'Initials': 'F', 'LastName': 'Ribordy Lambert', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Corentin A', 'Initials': 'CA', 'LastName': 'Wicht', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mouthon', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Spierer', 'Affiliation': 'Neurology Unit, Medicine Section, Faculty of Science and Medicine, University of Fribourg, 1700, Fribourg, Switzerland. Electronic address: lucas.spierer@unifr.ch.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116811']
5,32342253,The association of primary tumor site with acute adverse event and efficacy of definitive chemoradiotherapy for cStage II/III esophageal cancer: an exploratory analysis of JCOG0909.,"BACKGROUND


JCOG0909 is a phase II trial of definitive chemoradiotherapy including salvage treatment for cStage II-III thoracic esophageal cancer; the radiation field for elective regional lymph node irradiation, which can affect patient outcome and adverse event, varied based on the primary tumor site, i.e., upper (Ut), middle (Mt), and lower thoracic (Lt) esophagus. The impact of different primary sites on the safety and efficacy of definitive chemoradiotherapy in JCOG0909 is not well characterized.
METHODS


Patients were categorized into three groups (Ut, Mt, and Lt) according to the primary tumor location. We compared acute adverse events during definitive chemoradiotherapy, complete response (CR) rate, 3-year progression-free survival (PFS), and overall survival (OS) among the 3 groups.
RESULTS


Out of the 96 patients enrolled in JCOG0909 between April 2010 and August 2014, 94 patients (16, 59, and 19 patients in the Ut, Mt, and Lt groups, respectively) were included in this exploratory analysis. The proportion of patients with cStage III was 25% in the Ut, 37% in the Mt, and 47% in the Lt group. Grade 3-4 leukopenia, neutropenia, and thrombocytopenia were more frequently observed in the Mt (66%, 54%, and 15%) and Lt groups (84%, 68%, and 16%) than in the Ut group (38%, 44%, and 0%). There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%).
CONCLUSIONS


In JCOG0909, the incidence of severe hematological toxicity had a trend toward higher in the Mt and Lt than the Ut esophageal cancer; however, no remarkable difference by primary sites was observed with respect to efficacy endpoints.",2020,"There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%).
","['Patients were categorized into three groups (Ut, Mt, and Lt) according to the primary tumor location', 'cStage II/III esophageal cancer', '94 patients (16, 59, and 19 patients in the Ut, Mt, and Lt groups, respectively) were included in this exploratory analysis', '96 patients enrolled in JCOG0909 between April 2010 and August 2014', 'cStage II-III thoracic esophageal cancer']",['definitive chemoradiotherapy'],"['3-year PFS', '3-year OS', 'CR rate', 'safety and efficacy', 'complete response (CR) rate, 3-year progression-free survival (PFS), and overall survival (OS', 'severe hematological toxicity', 'Grade 3-4 leukopenia, neutropenia, and thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",96.0,0.0400083,"There was no significant between-group difference with respect to 3-year OS (73.3%, 77.9%, and 57.9%), 3-year PFS (60.0%, 59.3%, and 47.4%), or CR rate (62.5%, 62.7%, and 42.1%).
","[{'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka Hasama-machi Yufu, Oita, 879-5593, Japan. shironaka@oita-u.ac.jp.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Komori', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, 1-1 Idaigaoka Hasama-machi Yufu, Oita, 879-5593, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Onozawa', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Minashi', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Nozaki', 'Affiliation': 'Department of Surgery, Shikoku Cancer Center Hospital, Matsuyama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ura', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Surgery, Keio University School of Medicine, Tokyo, Japan.'}]",Esophagus : official journal of the Japan Esophageal Society,['10.1007/s10388-020-00741-w']
6,32280084,N-terminal pro-brain natriuretic peptide used for screening hemodynamically significant patent ductus arteriosus in very low birth weight infants: How and when?,"BACKGROUND


N-terminal pro-B-type natriuretic peptide (NTproBNP) appears to be a useful tool for diagnosing hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. However, a consensus for its application has not been reached.
OBJECTIVE


The present study aims to evaluate the role of NTproBNP in predicting hsPDA in preterm infants, and explore the optimal cutoff value and testing-time.
METHODS


A prospective blind study of 120 preterm infants with birth weights of < 1,500 g was conducted at the NICU of Peking University Shenzhen Hospital. Blood samples were successively collected on the first three days after birth for NTproBNP analysis. Echocardiographies were performed on day three of life to confirm the status of the ductus arteriosus. A receiver operating characteristic curve (ROC) analysis was performed to determine the ability of NTproBNP to recognize hsPDA.
RESULTS


NTproBNP was significantly higher in infants with hsPDA, than in infants in the control group, on both day two (P < 0.001) and day three (P < 0.001). On day two, a NTproBNP cutoff value of 3,689.0 pmol/L offered an optimal predictive value for hsPDA, while on day three, the optimal cut-off value for hsPDA was 2,331.5 pmol/L. The investigators proposes day three of life (48-72 hours) as the optimal testing time.
CONCLUSION


The NTproBNP biomarker during the early neonatal period can be a useful tool for screening and assessing hsPDA in premature infants, especially on day three of life.",2020,"RESULTS


NTproBNP was significantly higher in infants with hsPDA, than in infants in the control group, on both day two (P < 0.001) and day three (P < 0.001).","['120 preterm infants with birth weights of\u200a<\u200a1,500\u200ag was conducted at the NICU of Peking University Shenzhen Hospital', 'diagnosing hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants', 'preterm infants', 'very low birth weight infants']","['N-terminal pro-B-type natriuretic peptide (NTproBNP', 'NTproBNP']",[],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]",[],120.0,0.0403442,"RESULTS


NTproBNP was significantly higher in infants with hsPDA, than in infants in the control group, on both day two (P < 0.001) and day three (P < 0.001).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Zhen-Li', 'Initials': 'ZL', 'LastName': 'Huang', 'Affiliation': 'Department of Ultrasonic Diagnosis, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Department of Ultrasonic Diagnosis, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Shuang-Chuan', 'Initials': 'SC', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}, {'ForeName': 'Yu-Xin', 'Initials': 'YX', 'LastName': 'Zhou', 'Affiliation': 'Department of Neonatology, Peking University Shenzhen Hospital, ShenZhen, Guangdong, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190803']
7,32342118,[Reducing the risk of ipsilateral breast tumor relapse: external beam accelerated partial breast irradiation vs. whole breast irradiation following breast-conserving surgery in patients with ductal carcinoma in situ and node-negative breast cancer : The multicentric randomised RAPID trial].,,2020,,['patients with ductal carcinoma in situ and node-negative breast cancer '],['external beam accelerated partial breast irradiation vs. whole breast irradiation following breast-conserving surgery'],['risk of ipsilateral breast tumor relapse'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0433685,,"[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Souchon', 'Affiliation': ', Paul-Lincke-Ufer 8b, 10999, Berlin, Deutschland. r.souchon@t-online.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01609-9']
8,32348009,The effect of partial pulpotomy with iRoot BP Plus in traumatized immature permanent teeth: A randomized prospective controlled trial.,"BACKGROUND/AIM


A new bioceramic material iRoot BP Plus has been introduced and reported to have good biocompatibility, sealing ability and antibacterial activity. It has also been reported to be successfully used for procedures such as pulpotomy, pulp floor perforation repair and so on. However, there are only a few reports on the use of iRoot BP Plus in the management of traumatized teeth with an exposed pulp. The aim of this study was to investigate the clinical and radiographic outcomes of partial pulpotomy with iRoot BP Plus in immature permanent teeth with complicated crown fracture or complicated crown-root fracture.
MATERIAL AND METHODS


The study was prospectively designed, and 110 immature permanent teeth with complicated crown fracture or complicated crown-root fracture were randomly allocated into two groups (n = 55). All teeth were clinically and radiographically assessed at 1, 3, 6, 12, 18 and 24 months after partial pulpotomy with iRoot BP Plus (experimental group, n = 50) or calcium hydroxide (control group, n = 49) as the pulp capping agent. Eleven cases were lost during follow up, and 99 teeth were finally analysed.
RESULTS


There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness. The calcific bridge was significantly thinner in the iRoot BP Plus group than in the calcium hydroxide group (0.97 ± 0.13 mm vs 1.36 ± 0.12 mm; F = 5.128, P = .029).
CONCLUSIONS


iRoot BP Plus may be an effective capping material for partial pulpotomy.",2020,"There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness.","['Traumatised Immature Permanent Teeth', 'immature permanent teeth with complicated crown fracture or complicated crown-root fracture', '110 immature permanent teeth with complicated crown fracture or complicated crown-root fracture']","['calcium hydroxide (control group,n=49) as the pulp capping agent', 'iRoot BP', 'partial pulpotomy with iRoot BP Plus', 'Partial Pulpotomy with iRoot BP Plus', 'calcium hydroxide', 'bioceramic material iRoot BP']","['survival rate, survival time, root length and dentin wall thickness', 'calcific bridge']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936256', 'cui_str': 'Pulp Capping Agents'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C4043153', 'cui_str': 'iRoot BP Plus'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}]",11.0,0.0477762,"There were no intergroup differences in the survival rate, survival time, root length and dentin wall thickness.","[{'ForeName': 'YingTing', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'The Third Clinical Division of Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xia', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatric Dentistry, The Center for Pediatric Dentistry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Guili', 'Initials': 'G', 'LastName': 'Dou', 'Affiliation': 'Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'The Third Clinical Division of Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yong', 'Affiliation': 'Department of General Dentistry, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12563']
9,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04).
","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172']
10,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
11,32347885,Effect of Evolocumab on Type and Size of Subsequent Myocardial Infarction: A Prespecified Analysis of the FOURIER Randomized Clinical Trial.,"Importance


The PCSK9 inhibitor evolocumab reduced major vascular events in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, yet the types and sizes of myocardial outcomes in FOURIER have not been previously explored.
Objective


To assess the types and sizes of myocardial infarction (MI) and the effect of evolocumab on MI by subtype.
Design, Setting, and Participants


A prespecified analysis of a multicenter double-blind randomized clinical trial. Patients were randomized to evolocumab or placebo and followed up for a median of 2.2 years. The study included 27 564 patients with stable atherosclerotic disease receiving statin therapy. Clinical end points were evaluated by the Thrombolysis in Myocardial Infarction clinical events committee. Rates presented are 3-year Kaplan-Meier estimates. Data were collected from 2013 to 2016 and analyzed from June 2017 to December 2019.
Main Outcomes and Measures


Myocardial infarction was defined based on the third universal MI definition, and further classified according to MI type (universal MI subclass, ST-segment elevation myocardial infarction [STEMI] vs non-STEMI) and by MI size (determined by peak troponin level).
Results


A total of 27 564 patients were randomized, with a mean (SD) age of 62.5 (9.0) years, and 20 795 (75%) were male. Of these, 1107 patients experienced a total of 1288 MIs. Most MIs (68%) were atherothrombotic (type 1), with 15% from myocardial oxygen supply-demand mismatch (type 2) and 15% percutaneous coronary intervention-related (type 4). Sudden death (type 3) and coronary artery bypass grafting-related (type 5) accounted for a total of 21 MIs (<2%). Evolocumab significantly reduced the risk of first MI by 27% (4.4% vs 6.3%; hazard ratio [HR], 0.73; 95% CI, 0.65-0.82; P < .001), type 1 by 32% (2.9% vs 4.5%; HR, 0.68; 95% CI, 0.59-0.79; P < .001), and type 4 by 35% (0.8% vs 1.1%; HR, 0.65; 95% CI, 0.48-0.87; P = .004), with no effect on type 2 (0.9% vs 0.8%; HR, 1.09; 95% CI, 0.82-1.45; P = .56). Most MIs (688 [59.8%]) had troponin levels greater than or equal to 10 times the upper limit of normal. The benefit was highly significant and consistent regardless of the size of MI with a 34% reduction in MIs with troponin level greater than or equal to 10 times the upper limit of normal (2.6% vs 3.7%; HR, 0.66; 95% CI, 0.56-0.77; P < .001) and a 36% reduction in the risk of STEMI (1.0% vs 1.5%; HR, 0.64; 95% CI, 0.49-0.84; P < .001).
Conclusions and Relevance


Low-density lipoprotein cholesterol lowering with evolocumab was highly effective in reducing the risk of MI. This reduction with evolocumab included benefit across multiple subtypes of MI related to plaque rupture, smaller and larger MIs, and both STEMI and non-STEMI. These data are consistent with the known benefit of low-density lipoprotein cholesterol lowering and underscore the reduction in clinically meaningful events.
Trial Registration


ClinicalTrials.gov Identifier: NCT01764633.",2020,"Evolocumab significantly reduced the risk of first MI by 27% (4.4% vs 6.3%; hazard ratio [HR], 0.73; 95% CI, 0.65-0.82; P < .001), type 1 by 32% (2.9% vs 4.5%; HR, 0.68; 95% CI, 0.59-0.79; P < .001), and type 4 by 35% (0.8% vs 1.1%; HR, 0.65; 95% CI, 0.48-0.87; P = .004), with no effect on type 2 (0.9% vs 0.8%; HR, 1.09; 95% CI, 0.82-1.45; P = .56).","['Subjects With Elevated Risk (FOURIER) trial', 'A total of 27\u202f564 patients were randomized, with a mean (SD) age of 62.5 (9.0) years, and 20\u202f795 (75%) were male', '1107 patients experienced a total of 1288 MIs', 'Data were collected from 2013 to 2016 and analyzed from June 2017 to December 2019', '27\u202f564 patients with stable atherosclerotic disease receiving statin therapy']","['Evolocumab', 'evolocumab or placebo', 'evolocumab']","['Sudden death (type 3) and coronary artery bypass grafting-related (type 5', 'Myocardial Infarction clinical events committee', 'third universal MI definition, and further classified according to MI type (universal MI subclass, ST-segment elevation myocardial infarction [STEMI] vs non-STEMI) and by MI size (determined by peak troponin level', 'Measures\n\n\nMyocardial infarction', 'MIs with troponin level', 'troponin levels', 'risk of first MI', 'Type and Size of Subsequent Myocardial Infarction', 'risk of STEMI']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1536222', 'cui_str': 'Non STEMI'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1273976', 'cui_str': 'First myocardial infarction'}, {'cui': 'C0348593', 'cui_str': 'Subsequent myocardial infarction'}]",27564.0,0.35474,"Evolocumab significantly reduced the risk of first MI by 27% (4.4% vs 6.3%; hazard ratio [HR], 0.73; 95% CI, 0.65-0.82; P < .001), type 1 by 32% (2.9% vs 4.5%; HR, 0.68; 95% CI, 0.59-0.79; P < .001), and type 4 by 35% (0.8% vs 1.1%; HR, 0.65; 95% CI, 0.48-0.87; P = .004), with no effect on type 2 (0.9% vs 0.8%; HR, 1.09; 95% CI, 0.82-1.45; P = .56).","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Gaetano M', 'Initials': 'GM', 'LastName': 'De Ferrari', 'Affiliation': 'Department of Medical Sciences, University of Torino, Cardiology AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center, Haifa, Israel.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Wilhelminen Hospital, Vienna, Austria.'}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Forni', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kurtz', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Thousand Oaks, California.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Center, University of Sydney, Sydney Australia.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ulleval and Medical Faculty, University of Oslo, Oslo Norway.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.0764']
12,32347887,An Exploratory Analysis of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition and Aortic Stenosis in the FOURIER Trial.,"Importance


Despite recent advances in treatment of severe aortic valve stenosis (AS), AS remains a life-threatening condition with no proven disease-modifying therapy. Low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a]) have been implicated in the pathobiology of AS. The proprotein convertase subtilisin/kexin type 9 inhibitor evolocumab reduces circulating LDL-C concentrations by 50% to 60% and Lp(a) by 20% to 30%.
Objective


To determine whether evolocumab reduces the risk of AS events in patients with atherosclerotic cardiovascular disease.
Interventions


Patients were randomized 1:1 to evolocumab or placebo.
Design, Setting, and Participants


Exploratory analysis of the FOURIER trial, which enrolled 27 564 patients with stable atherosclerotic cardiovascular disease who were taking statin therapy at 1242 sites in 49 countries from February 2013 to November 2016. Patients were randomized to evolocumab or placebo and followed up for a median (interquartile range) of 2.2 (1.8-2.5) years. This post hoc analysis was performed from September 2019 to February 2020.
Main Outcomes and Measures


Site-reported adverse events of new or worsening AS or aortic valve replacement (termed AS events). The adjusted risk of AS events was calculated with a multivariable model including concentrations of Lp(a) and LDL-C corrected for Lp(a) content, plus age, sex, diabetes, hypertension, current smoking, and estimated glomerular filtration rate. Evolocumab efficacy was tested using a Cox proportional hazards model.
Results


Aortic stenosis events occurred in 63 patients (48 men [76%]; mean [SD] age, 69 [9] years) over a median of 2.2 years. Elevated Lp(a) concentration was associated with higher rates of AS events (adjusted hazard ratio [aHR], 1.55 [95% CI, 1.17-2.05] per SD; P = .002), including aortic valve replacement (aHR, 2.22 [95% CI, 1.38-3.58] per SD; P = .001), after multivariable adjustment. The corrected LDL-C concentration was not significantly associated with AS events (aHR, 1.23 [95% CI, 0.93-1.61] per SD; P = .14). The overall HR for AS events with evolocumab was 0.66 (95% CI, 0.40-1.09), with no apparent association in the first year (HR, 1.09 [95% CI, 0.48-2.47]) but an HR of 0.48 (95% CI, 0.25-0.93) after the first year of treatment.
Conclusions and Relevance


In this exploratory analysis of the FOURIER trial, higher Lp(a) levels, but not Lp(a)-corrected LDL-C levels, were associated with a higher risk of subsequent AS events, including aortic valve replacement. Long-term therapy with evolocumab may reduce AS events, and this raises the possibility that specific pharmacologic lipid-lowering therapy could offer a means to prevent or slow the progression of AS. These exploratory findings merit further investigation with a dedicated randomized clinical trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT01764633.",2020,"The corrected LDL-C concentration was not significantly associated with AS events (aHR, 1.23 [95% CI, 0.93-1.61] per SD; P = .14).","['September 2019 to February 2020', 'patients with atherosclerotic cardiovascular disease', 'severe aortic valve stenosis (AS', '63 patients (48 men [76', '564 patients with stable atherosclerotic cardiovascular disease who were taking statin therapy at 1242 sites in 49 countries from February 2013 to November 2016', 'mean [SD] age, 69 [9] years) over a median of 2.2 years']","['evolocumab or placebo', 'evolocumab']","['Measures\n\n\nSite-reported adverse events of new or worsening AS or aortic valve replacement (termed AS events', 'aortic valve replacement', 'circulating LDL-C concentrations', 'Evolocumab efficacy', 'corrected LDL-C concentration', 'overall HR for AS events with evolocumab', 'adjusted risk of AS events', 'Elevated Lp(a) concentration', 'Aortic stenosis events', 'concentrations of Lp(a) and LDL-C corrected for Lp(a) content, plus age, sex, diabetes, hypertension, current smoking, and estimated glomerular filtration rate', 'Low-density lipoprotein cholesterol (LDL-C) and lipoprotein(a) (Lp[a']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]",27564.0,0.256035,"The corrected LDL-C concentration was not significantly associated with AS events (aHR, 1.23 [95% CI, 0.93-1.61] per SD; P = .14).","[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': ""O'Donoghue"", 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marat V', 'Initials': 'MV', 'LastName': 'Ezhov', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ceška', 'Affiliation': 'Third Internal Medicine Clinic, Center for Preventive Cardiology, University General Hospital, First Medical Faculty, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'Polyclinic for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Henrik K', 'Initials': 'HK', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'S Lale', 'Initials': 'SL', 'LastName': 'Tokgozoglu', 'Affiliation': 'Department of Cardiology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Cardiology Division, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Cardiology and Intensive Care Medicine, Wilhelminenhospital, Third Department of Medicine, Sigmund Freud University, Medical Faculty, Vienna, Austria.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Gaciong', 'Affiliation': 'Department of Internal Medicine, Hypertension and Vascular Disease, the Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'The Ruth and Bruce Rappaport School of Medicine, Lady Davis Carmel Medical Center, Technion-IIT, Haifa, Israel.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Schiele', 'Affiliation': 'University Hospital Center Besançon, Besançon, France.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, the Netherlands.'}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo University Hospital, Ullevål and Medical Faculty, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2020.0728']
13,32347899,Effect of Gonadotropin-Releasing Hormone Antagonist on Risk of Committing Child Sexual Abuse in Men With Pedophilic Disorder: A Randomized Clinical Trial.,"Importance


Evidence-based treatments from randomized clinical trials for pedophilic disorder are lacking.
Objective


To determine whether a gonadotropin-releasing hormone antagonist reduces dynamic risk factors for committing child sexual abuse.
Design, Setting, and Participants


This academically initiated, double-blind, placebo-controlled, parallel-group, phase 2 randomized clinical trial was conducted at the ANOVA center in Stockholm, Sweden, from March 1, 2016, to April 30, 2019. Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited. Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention. The primary end point was assessed by intent-to-treat analysis.
Interventions


Randomization to receive either 2 subcutaneous injections of 120 mg of degarelix acetate or equal volume of placebo.
Main Outcomes and Measures


The primary end point was the mean change between baseline and 2 weeks in the composite risk score of 5 domains of child sexual abuse ranging from 0 to 15 points; each domain could be rated from 0 to 3 points. Secondary end points included efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events.
Results


A total of 52 male participants (mean [SD] age, 36 [12] years) were randomized to receive either degarelix (n = 25; with 1 withdrawal) or placebo (n = 26). At 2 weeks, the composite risk score decreased from 7.4 to 4.4 for participants in the degarelix group and from 7.8 to 6.6 for the placebo group, a mean between-group difference of -1.8 (95% CI, -3.2 to -0.5; P = .01). A decrease was seen in the composite score at 10 weeks (-2.2 [95% CI, -3.6 to -0.7]) as well as in the domains of pedophilic disorder (2 weeks: -0.7 [95% CI, -1.4 to 0.0]; 10 weeks: -1.1 [95% CI, -1.8 to -0.4]) and sexual preoccupation (2 weeks: -0.7 [95% CI, -1.2 to -0.3]; 10 weeks: -0.8 [95% CI, -1.3 to -0.3]) in the degarelix group compared with the placebo group. No difference was seen for the domains of self-rated risk (2 weeks: -0.4 [95% CI, -0.9 to 0.1]; 10 weeks: -0.5 [95% CI, -1 to 0.0]), low empathy (2 weeks: 0.2 [95% CI, -0.3 to 0.6]; 10 weeks: 0.2 [95% CI, -0.2 to 0.6]), and impaired self-regulation (2 weeks: -0.0 [95% CI, -0.7 to 0.6]; 10 weeks: 0.1 [95% CI, -0.5 to 0.8]), or quality of life (EuroQol 5 Dimensions questionnaire index score, 2 weeks: 0.06 [95% CI, -0.00 to 0.12], and 10 weeks: 0.04; 95% CI, -0.02 to 0.10; EuroQol visual analog scale, 2 weeks: 0.6 [95% CI, -9.7 to 10.9], and 10 weeks: 4.2 [95% CI, -6.0 to 14.4]). Two hospitalizations occurred from increased suicidal ideation, and more injection site reactions (degarelix: 22 of 25 [88%]; placebo: 1 of 26 [4%]) and hepatobiliary enzyme level elevations were reported by participants who received degarelix (degarelix: 11 of 25 [44%]; placebo: 2 of 26 [8%]). Among the 26 participants randomized to receive degarelix, 20 (77%) experienced positive effects (eg, improved attitude or behavior) on sexuality and 23 (89%) reported adverse effects on the body.
Conclusion and Relevance


This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option. Further studies are warranted into the effects and long-term adverse effects of hormone deficiency.
Trial Registration


EU Clinical Trials Register Identifier: 2014-000647-32.",2020,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","['committing child sexual abuse', 'Eligible participants were men seeking help aged 18 to 66 years with a pedophilic disorder diagnosis and no contraindications to the intervention', 'Individuals who contacted PrevenTell, the national telephone helpline for unwanted sexuality, were recruited', 'Men With Pedophilic Disorder', '52 male participants (mean [SD] age, 36 [12] years']","['Gonadotropin-Releasing Hormone Antagonist', 'degarelix acetate or equal volume of placebo', 'gonadotropin-releasing hormone antagonist', 'degarelix (degarelix', 'degarelix', 'placebo']","['sexual preoccupation', 'intent-to-treat analysis', 'low empathy', 'efficacy at 2 and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects, and adverse events', 'composite risk score of 5 domains of child sexual abuse', 'Risk of Committing Child Sexual Abuse', 'composite risk score', 'suicidal ideation', 'hepatobiliary enzyme level elevations', 'composite score', 'impaired self-regulation', 'positive effects (eg, improved attitude or behavior) on sexuality', 'adverse effects', 'EuroQol visual analog scale', 'quality of life (EuroQol 5 Dimensions questionnaire index score', 'injection site reactions']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C2718533', 'cui_str': 'degarelix acetate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}]","[{'cui': 'C0423988', 'cui_str': 'Sexual preoccupation'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0014440', 'cui_str': 'Enzyme measurement'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",52.0,0.615958,"This trial found that degarelix reduced the risk score for committing child sexual abuse in men with pedophilic disorder 2 weeks after initial injection, suggesting use of the drug as a rapid-onset treatment option.","[{'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Landgren', 'Affiliation': 'Institute of Neuroscience and Physiology, Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Kinda', 'Initials': 'K', 'LastName': 'Malki', 'Affiliation': 'Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bottai', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Rahm', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0440']
14,32347907,A Randomized Clinical Trial in Patients With a Pedophilic Disorder: A Milestone.,,2020,,['Patients With a Pedophilic Disorder'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],[],,0.2009,,"[{'ForeName': 'Peer', 'Initials': 'P', 'LastName': 'Briken', 'Affiliation': 'Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, University Medical Centre, Hamburg, Germany.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0430']
15,32343963,Long-term Noninvasive Ventilation in Obesity Hypoventilation Syndrome Without Severe OSA: The Pickwick Randomized Controlled Trial.,"BACKGROUND


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


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


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


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


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


ClinicalTrials.gov; No.: NCT01405976; URL: www.clinicaltrials.gov.",2020,"NIV therapy, in contrast to control group, produced significant longitudinal improvement in PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness.","['49 patients in the NIV group and 49 in the control group were randomized and 48 patients in each group were analyzed', '98 stable ambulatory patients with untreated OHS and apnea-hypopnea index <30 events/hour (i.e., no severe OSA) to', 'obesity hypoventilation syndrome (OHS) with severe obstructive sleep apnea (OSA', 'Obesity Hypoventilation Syndrome without Severe Obstructive Sleep Apnea', 'stable ambulatory patients with OHS without severe OSA', 'OHS patients without severe OSA phenotype']","['Long-term Noninvasive Ventilation', 'Noninvasive ventilation (NIV', 'NIV or lifestyle modification (control group) using simple randomization through an electronic database']","['hospitalization days/year', 'PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness', 'hospital resource utilization, incident cardiovascular events, mortality, respiratory functional tests, blood pressure, quality of life, sleepiness and other clinical symptoms', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0031880', 'cui_str': 'Extreme obesity with alveolar hypoventilation'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0556972', 'cui_str': 'days/year'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",98.0,0.143898,"NIV therapy, in contrast to control group, produced significant longitudinal improvement in PaCO 2 , pH, bicarbonate, quality of life (SF-36 physical component) and daytime sleepiness.","[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain. Electronic address: fmasa@separ.es.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Maria Á', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain; Respiratory Department, Virgen del Puerto Hospital, Plasencia, Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Gomez de Terreros', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral', 'Affiliation': 'Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain; CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero-Eraso', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, University Hospital, Burgos, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gomez-Garcia', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, IIS Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañón Hospital, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Miguel Servet Hospital, Zaragoza, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': ""CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Vall d'Hebron Hospital, Barcelona, Spain.""}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Doce de Octubre Hospital, Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Respiratory Department, Alava University Hospital IRB, Vitoria, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Instituto Universitario de Investigación Biosanitaria de Extremadura (INUBE), Badajoz, Spain; Nursing Department, Extremadura University, Cáceres, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, Las Palmas de Gran Canaria University, Canary Islands, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain; Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Department of Medicine/Pulmonary and Critical Care, University of Chicago, IL.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.03.068']
16,32282587,Accelerated Approval of 17α-Hydroxyprogesterone Caproate: A Cautionary Tale.,"Before 2011, 17α-hydroxyprogesterone caproate (17P) was used to prevent recurrent preterm birth in women with singleton pregnancies and was compounded at a low cost (∼$15 per injection). In 2011, the U.S. Food and Drug Administration (FDA) approved a commercial version of 17P (trade name ""Makena"") through their Accelerated Approval Program, and the price of 17P subsequently increased by nearly 100-fold. This approval was largely based on a methodologically limited, placebo-controlled trial, which found that although 17P significantly reduced preterm births, the placebo group had significantly more participants with a history of preterm birth, potentially confounding the results. The FDA required a confirmatory trial for continued approval that demonstrated clinical benefit. Eight years after accelerated approval, the confirmatory trial, PROLONG (Progestin's Role in Optimizing Neonatal Gestation), found no evidence of an effect of Makena for reducing recurrent preterm birth or perinatal mortality. Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth. Although the FDA created the Accelerated Approval Program to introduce therapies for serious conditions that lacked treatment options, Makena is an example of the limitations of this program. We encourage the FDA to re-evaluate their program and consider improvements, such as shorter timeframes to complete confirmatory trials, potentially revoking approval if the studies are not completed within a predefined timeframe, and to hold manufacturers responsible, in part, for the costs of therapy if they cannot prove a clinical benefit.",2020,"Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth.",['women with singleton pregnancies'],"['17α-hydroxyprogesterone caproate (17P', '17α-Hydroxyprogesterone Caproate', 'placebo']","['recurrent preterm birth or perinatal mortality', 'recurrent preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}]",,0.196624,"Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth.","[{'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Godlewski', 'Affiliation': 'Center for Evidence-based Policy at Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Sobolik', 'Affiliation': ''}, {'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Curtis S', 'Initials': 'CS', 'LastName': 'Harrod', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003787']
17,32352493,Safety and Vision Outcomes of Subretinal Gene Therapy Targeting Cone Photoreceptors in Achromatopsia: A Nonrandomized Controlled Trial.,"Importance


Achromatopsia linked to variations in the CNGA3 gene is associated with day blindness, poor visual acuity, photophobia, and involuntary eye movements owing to lack of cone photoreceptor function. No treatment is currently available.
Objective


To assess safety and vision outcomes of supplemental gene therapy with adeno-associated virus (AAV) encoding CNGA3 (AAV8.CNGA3) in patients with CNGA3-linked achromatopsia.
Design, Setting, and Participants


This open-label, exploratory nonrandomized controlled trial tested safety and vision outcomes of gene therapy vector AAV8.CNGA3 administered by subretinal injection at a single center. Nine patients (3 per dose group) with a clinical diagnosis of achromatopsia and confirmed biallelic disease-linked variants in CNGA3 were enrolled between November 5, 2015, and September 22, 2016. Data analysis was performed from June 6, 2017, to March 12, 2018.
Intervention


Patients received a single unilateral injection of 1.0 × 1010, 5.0 × 1010, or 1.0 × 1011 total vector genomes of AAV8.CNGA3 and were followed up for a period of 12 months (November 11, 2015, to October 10, 2017).
Main Outcomes and Measures


Safety as the primary end point was assessed by clinical examination of ocular inflammation. Systemic safety was assessed by vital signs, routine clinical chemistry testing, and full and differential blood cell counts. Secondary outcomes were change in visual function from baseline in terms of spatial and temporal resolution and chromatic, luminance, and contrast sensitivity throughout a period of 12 months after treatment.
Results


Nine patients (mean [SD] age, 39.6 [11.9] years; age range, 24-59 years; 8 [89%] male) were included in the study. Baseline visual acuity letter score (approximate Snellen equivalent) ranged from 34 (20/200) to 49 (20/100), whereas baseline contrast sensitivity log scores ranged from 0.1 to 0.9. All 9 patients underwent surgery and subretinal injection of AAV8.CNGA3 without complications. No substantial safety problems were observed during the 12-month follow-up period. Despite the congenital deprivation of cone photoreceptor-mediated vision in achromatopsia, all 9 treated eyes demonstrated some level of improvement in secondary end points regarding cone function, including mean change in visual acuity of 2.9 letters (95% CI, 1.65-4.13; P = .006, 2-sided t test paired samples). Contrast sensitivity improved by a mean of 0.33 log (95% CI, 0.14-0.51 log; P = .003, 2-sided t test paired samples).
Conclusions and Relevance


Subretinal gene therapy with AAV8.CNGA3 was not associated with substantial safety problems and was associated with cone photoreceptor activation in adult patients, as reflected by visual acuity and contrast sensitivity gains.
Trial Registration


ClinicalTrials.gov Identifier: NCT02610582.",2020,"Contrast sensitivity improved by a mean of 0.33 log (95% CI, 0.14-0.51 log; P = .003, 2-sided t test paired samples).
","['Achromatopsia', 'patients with CNGA3-linked achromatopsia', 'Nine patients (mean [SD] age, 39.6 [11.9] years; age range, 24-59 years; 8 [89%] male) were included in the study', 'Nine patients (3 per dose group) with a clinical diagnosis of achromatopsia and confirmed biallelic disease-linked variants in CNGA3 were enrolled between November 5, 2015, and September 22, 2016']","['therapy vector AAV8.CNGA3', 'Subretinal Gene Therapy Targeting Cone Photoreceptors', 'AAV8.CNGA3', 'single unilateral injection of 1.0\u2009×\u20091010, 5.0\u2009×\u20091010, or 1.0\u2009×\u20091011 total vector genomes of AAV8.CNGA3', 'supplemental gene therapy with adeno-associated virus (AAV) encoding CNGA3']","['visual acuity', 'vital signs, routine clinical chemistry testing, and full and differential blood cell counts', 'Contrast sensitivity', 'visual acuity and contrast sensitivity gains', 'Safety and Vision Outcomes', 'Systemic safety', 'Baseline visual acuity letter score', 'change in visual function from baseline in terms of spatial and temporal resolution and chromatic, luminance, and contrast sensitivity', 'substantial safety problems', 'clinical examination of ocular inflammation', 'safety and vision outcomes']","[{'cui': 'C0152200', 'cui_str': 'Achromatopsia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C2699708', 'cui_str': 'Subretinal route'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C1564874', 'cui_str': 'Adeno-Associated Viruses'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0428763', 'cui_str': 'Temporal resolution'}, {'cui': 'C0234684', 'cui_str': 'Luminance'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.3268,"Contrast sensitivity improved by a mean of 0.33 log (95% CI, 0.14-0.51 log; P = .003, 2-sided t test paired samples).
","[{'ForeName': 'M Dominik', 'Initials': 'MD', 'LastName': 'Fischer', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Michalakis', 'Affiliation': 'Center for Integrated Protein Science Munich, Department of Pharmacy, Center for Drug Research, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wilhelm', 'Affiliation': 'Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Ditta', 'Initials': 'D', 'LastName': 'Zobor', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Muehlfriedel', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Kohl', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Weisschuh', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'G Alex', 'Initials': 'GA', 'LastName': 'Ochakovski', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Reinhild', 'Initials': 'R', 'LastName': 'Klein', 'Affiliation': 'Department of Internal Medicine II, University Hospital Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schoen', 'Affiliation': 'Center for Integrated Protein Science Munich, Department of Pharmacy, Center for Drug Research, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Vithiyanjali', 'Initials': 'V', 'LastName': 'Sothilingam', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garcia-Garrido', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kuehlewein', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kahle', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Werner', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Daniyar', 'Initials': 'D', 'LastName': 'Dauletbekov', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Paquet-Durand', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tsang', 'Affiliation': 'Department of Ophthalmology, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martus', 'Affiliation': 'Institute for Clinical Epidemiology and Applied Biostatistics, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Seeliger', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Karl Ulrich', 'Initials': 'KU', 'LastName': 'Bartz-Schmidt', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ueffing', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Eberhart', 'Initials': 'E', 'LastName': 'Zrenner', 'Affiliation': 'University Eye Hospital, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Biel', 'Affiliation': 'Center for Integrated Protein Science Munich, Department of Pharmacy, Center for Drug Research, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wissinger', 'Affiliation': 'Institute for Ophthalmic Research, Centre for Ophthalmology, University Hospital Tübingen, Tübingen, Germany.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1032']
18,32353714,Music during image-guided breast biopsy reduces patient anxiety levels.,"PURPOSE


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


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


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


Listening to self-selected music reduces anxiety in patients undergoing breast biopsy.",2020,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","['patients undergoing breast biopsy', '157 women between 18 and 75 (mean, 49.7\xa0years) years of age, undergoing stereotactic or ultrasound-guided core biopsy']","['Music intervention', 'music or usual care', 'Listening to self-selected music', 'music group listened to music of their choice during the biopsy', 'Music during image-guided breast biopsy', 'listening to self-selected music during image-guided breast biopsy']","['anxiety', 'pre-biopsy and post-biopsy anxiety levels', 'state anxiety levels', 'Post-biopsy anxiety levels', 'Baseline trait anxiety scores', 'State Trait Anxiety Inventory (STAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}]",157.0,0.0640536,"Patients who listened to music showed a greater reduction in anxiety (mean decrease 11.2 music, 7.3 control, p = .03).","[{'ForeName': 'Debbie L', 'Initials': 'DL', 'LastName': 'Bennett', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America. Electronic address: Debbie.bennett@health.slu.edu.'}, {'ForeName': 'J Shannon', 'Initials': 'JS', 'LastName': 'Swan', 'Affiliation': 'MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Gazelle', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America; MGH Institute for Technology Assessment, 101 Merrimac Street, 10(th) Floor, Boston, MA 02114, United States of America.'}, {'ForeName': 'Mansi', 'Initials': 'M', 'LastName': 'Saksena', 'Affiliation': 'Massachusetts General Hospital, Department of Radiology, Division of Breast Imaging, Wang ACC 240, 15 Parkman Street, Boston, MA 02114, United States of America.'}]",Clinical imaging,['10.1016/j.clinimag.2020.03.018']
19,32353619,Suture Tape Reduces Quadriceps Tendon Repair Gap Formation Compared With High-Strength Suture: A Cadaveric Biomechanical Analysis.,"PURPOSE


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


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


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


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


When performing QT repair, emphasis should be placed on appropriate pretensioning of sutures to at least 150 N before knot-tying. In addition, where available, ST should be used over HSS to reduce further cyclic elongation and improve ultimate failure loads.",2020,ST demonstrated significantly less displacement than HSS under cyclic loading and had greater ultimate failure loads.conclusion,['28 fresh-frozen QTs'],"['quadriceps tendon (QT) repair with high-strength suture (HSS) versus suture tape (ST', 'HSS; or ii) ST', 'High Strength Suture', 'Suture Tape']","['number of suture or tape passes.results', 'Quadriceps Tendon Repair Gap Formation', 'ultimate failure loads.conclusion', 'mean (±SD) displacement']","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}]","[{'cui': 'C0224941', 'cui_str': 'Structure of quadriceps tendon'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0457280', 'cui_str': 'Number of sutures'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0547072', 'cui_str': 'Repair of quadriceps'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}]",,0.0324435,ST demonstrated significantly less displacement than HSS under cyclic loading and had greater ultimate failure loads.conclusion,"[{'ForeName': 'Philip P', 'Initials': 'PP', 'LastName': 'Roessler', 'Affiliation': 'Fowler Kennedy Sports Medicine Clinic, 3M Center, Western University, London Ontario, Canada.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Burkhart', 'Affiliation': 'Lawson Health Research Institute, Mechanical and Materials Engineering, Western University, London Ontario, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Getgood', 'Affiliation': 'Fowler Kennedy Sports Medicine Clinic, 3M Center, Western University, London Ontario, Canada.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Degen', 'Affiliation': 'Fowler Kennedy Sports Medicine Clinic, 3M Center, Western University, London Ontario, Canada. Electronic address: Ryan.degen@lhsc.on.ca.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.04.020']
20,32356926,Telmisartan as tentative angiotensin receptor blocker therapeutic for COVID-19.,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic. This new disease was named COVID-19 and the causative virus SARS-CoV-2. The SARS-CoV-2 virus enters the airway and binds, by means of the S protein on its surface to the membrane protein ACE2 in type 2 alveolar cells. The S protein-ACE2 complex is internalized by endocytosis leading to a partial decrease or total loss of the enzymatic function ACE2 in the alveolar cells and in turn increasing the tissue concentration of pro-inflammatory angiotensin II by decreasing its degradation and reducing the concentration of its physiological antagonist angiotensin 1-7. High levels of angiotensin II on the lung interstitium can promote apoptosis initiating an inflammatory process with release of proinflammatory cytokines, establishing a self-powered cascade, leading eventually to ARDS. Recently, Gurwitz proposed the tentative use of agents such as losartan and telmisartan as alternative options for treating COVID-19 patients prior to development of ARDS. In this commentary article, the authors make the case for the election of telmisartan as such alternative on the basis of its pharmacokinetic and pharmacodynamic properties and present an open-label randomized phase II clinical trial for the evaluation of telmisartan in COVID-19 patients (NCT04355936).",2020,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic.",[],"['Telmisartan', 'telmisartan', 'losartan and telmisartan']",[],[],"[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]",[],,0.0151336,"In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic.","[{'ForeName': 'Rodolfo Pedro', 'Initials': 'RP', 'LastName': 'Rothlin', 'Affiliation': 'Sociedad Argentina de Farmacología Clínica, Asociación Médica Argentina, Buenos Aires, Argentina.'}, {'ForeName': 'Héctor Miguel', 'Initials': 'HM', 'LastName': 'Vetulli', 'Affiliation': 'Servicio de Electrofisiología Cardíaca, Arritmias y Marcapasos, Sanatorio Otamendi y Miroli, Buenos Aires, Argentina.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': 'Hospital de Clínicas ""José de San Martín"", Facultad de Medicina, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Facundo Germán', 'Initials': 'FG', 'LastName': 'Pelorosso', 'Affiliation': 'Department of Pathology, Hospital de Alta Complejidad El Calafate SAMIC, Santa Cruz, Argentina.'}]",Drug development research,['10.1002/ddr.21679']
21,32358661,Comparison of the short-term results of single-dose intra-articular peptide with hyaluronic acid and platelet-rich plasma injections in knee osteoarthritis: a randomized study.,"INTRODUCTION/OBJECTIVES


Intra-articular injections may be useful in terms of pain and functional status, in knee osteoarthritis (OA). Besides hyaluronic acid (HA) and platelet-rich plasma (PRP), peptide molecules recently begin to be used. The aim of this study was to compare the efficacy of intra-articular peptide Prostrolane® (CAREGEN Co. Ltd.) injection with that of the HA and PRP in the persons with OA.
METHOD


Fifty-four patients with OA were included in this prospective, randomized study. Patients were randomized into three groups as intra-articular HA, peptide, and PRP groups. Paracetamol was permitted three times a day to all groups. All the patients were evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), and visual analogue scale (VAS) at rest and during movements. Measurements performed at the baseline, after the first week of injection, and at the first and third months of follow-up.
RESULTS


Mean age was 55.8 ± 8.9 years. Forty-four (81.6%) were women. A week after the injections, rest and movement pain severity was measured by VAS decreased significantly in all the study groups (p < 0.05). There were no statistically significant differences between the groups in terms of first week pain relief (p > 0.05). WOMAC pain, stiffness, function, and total scores were improved significantly in all the groups a week after the injections (p < 0.05). Improvement continued at the third month control; however, the improvement in the WOMAC pain score was significantly better in the peptide group at the third month control (p < 0.05). The decrease in the rest and movement pain was continued for 3 months except the HA group's rest pain. There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group.
CONCLUSION


As a result, pain relief and functional improvement were obtained after the intra-articular HA, peptide, and PRP injections in OA, and decrease in pain was better in the peptide group. Key Points • The short-term effects of intra-articular HA, peptide, and PRP injections were compared in knee osteoarthritis. • HA, peptide, and PRP injections may be useful in pain relief and functional improvement in knee osteoarthritis.",2020,"There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group.
","['persons with OA', 'Fifty-four patients with OA', 'Mean age was 55.8\u2009±\u20098.9\xa0years', 'knee osteoarthritis', 'Forty-four (81.6%) were women']","['hyaluronic acid (HA', 'intra-articular HA, peptide, and PRP injections', 'Paracetamol', 'hyaluronic acid and platelet-rich plasma injections', 'intra-articular peptide Prostrolane®']","['rest and movement pain', 'pain relief', 'pain relief and functional improvement', 'VAS', 'rest and movement pain severity', 'WOMAC pain, stiffness, function, and total scores', 'pain', 'WOMAC pain score', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), and visual analogue scale (VAS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}]",54.0,0.0229307,"There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group.
","[{'ForeName': 'Fatma Nur', 'Initials': 'FN', 'LastName': 'Kesiktas', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey. nur.kesiktas@gmail.com.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Dernek', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Ekin Ilke', 'Initials': 'EI', 'LastName': 'Sen', 'Affiliation': 'Department of PMR, MD, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Havva Nur', 'Initials': 'HN', 'LastName': 'Albayrak', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Aydin', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Yildiz', 'Affiliation': 'Department of PMR, MD, Istanbul Physical Medicine and Rehabilitation Education Research Hospital, University of Health Sciences, Istanbul, Turkey.'}]",Clinical rheumatology,['10.1007/s10067-020-05121-4']
22,32352505,Efficacy of Nivolumab and AVD in Early-Stage Unfavorable Classic Hodgkin Lymphoma: The Randomized Phase 2 German Hodgkin Study Group NIVAHL Trial.,"Importance


In early-stage unfavorable classic Hodgkin lymphoma (cHL), conventional therapy induces high cure rates but also relevant acute and long-term toxic effects. Nivolumab is well tolerated and highly effective in relapsed/refractory cHL but has not been adequately studied in first-line treatment of early-stage cHL. The NIVAHL trial evaluated nivolumab in this setting with the aim to develop a highly effective yet tolerable systemic therapy to ultimately mitigate morbidity in patients who survive cHL.
Objective


To evaluate efficacy of 2 experimental nivolumab-based first-line treatment strategies in patients with early-stage unfavorable cHL.
Design, Setting, and Participants


This was an open-label, multicenter, phase 2 randomized clinical trial, open between April 2017 and October 2018. The trial took place at 35 trial centers across Germany, ranging from academic centers to private offices. Eligibility was defined by age 18 to 60 years, cHL confirmed by expert pathology review, early-stage unfavorable disease by German Hodgkin Study Group criteria (stage I to II with risk factor[s]), and absence of serious concomitant disease or organ dysfunction. Among 110 enrolled patients, 109 were eligible.
Interventions


Systemic therapy, per random assignment (1:1) to either concomitant treatment with 4 cycles of nivolumab and doxorubicin, vinblastine, and dacarbazine (N-AVD) or sequential treatment with 4 doses of nivolumab, 2 cycles of N-AVD, and 2 cycles of AVD at standard doses, followed by 30-Gy involved-site radiotherapy.
Main Outcomes and Measures


Complete remission (CR) rate after study treatment, aiming at excluding a CR rate of 80% or lower via a 2-sided 95% CI for each treatment group.
Results


Of 109 patients included in this study, 65 (59.6%) were women, and the median (range) age was 27 (18-60) years. At interim staging after 2 cycles of N-AVD or 4 doses of nivolumab monotherapy, 54 of 54 (100%) and 49 of 51 (96%) response-eligible patients, respectively, achieved an objective response, with CR in 47 (87%) and 26 (51%) patients, respectively. Among 101 patients eligible for primary end point analysis, 46 of 51 (90%; 95% CI, 79%-97%) patients receiving concomitant therapy and 47 of 50 (94%; 95% CI, 84%-99%) patients receiving sequential therapy achieved CR after study treatment. With a median follow-up of 13 months, 12-month progression-free survival was 100% for patients receiving concomitant treatment and 98% (95% CI, 95%-100%) for patients receiving sequential therapy.
Conclusions and Relevance


Both strategies combining nivolumab and AVD are feasible and resulted in high remission rates. Despite narrowly missing the efficacy benchmark in the concomitant group, the excellent 12-month progression-free survival and the unexpectedly high CR rate after 4 doses of nivolumab monotherapy warrant further evaluation of this approach in the first-line treatment of patients with early-stage cHL.
Trial Registration


ClinicalTrials.gov Identifier: NCT03004833.",2020,"With a median follow-up of 13 months, 12-month progression-free survival was 100% for patients receiving concomitant treatment and 98% (95% CI, 95%-100%) for patients receiving sequential therapy.
","['110 enrolled patients, 109 were eligible', 'Early-Stage Unfavorable Classic Hodgkin Lymphoma', 'Eligibility was defined by age 18 to 60 years, cHL confirmed by expert pathology review, early-stage unfavorable disease by German Hodgkin Study Group criteria (stage I to II with risk factor[s]), and absence of serious concomitant disease or organ dysfunction', '109 patients included in this study, 65 (59.6%) were women, and the median (range) age was 27 (18-60) years', '35 trial centers across Germany, ranging from academic centers to private offices', 'patients with early-stage cHL', 'open between April 2017 and October 2018', 'patients with early-stage unfavorable cHL', 'patients who survive cHL']","['Nivolumab', 'nivolumab and doxorubicin, vinblastine, and dacarbazine (N-AVD) or sequential treatment with 4 doses of nivolumab, 2 cycles of N-AVD, and 2 cycles of AVD at standard doses, followed by 30-Gy involved-site radiotherapy', '2 experimental nivolumab-based first-line treatment strategies', 'nivolumab monotherapy', 'Nivolumab and AVD']","['Measures\n\n\nComplete remission (CR) rate', '12-month progression-free survival', 'CR rate']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0243087', 'cui_str': 'concomitant disease'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0230822', 'cui_str': 'Autolysosome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",110.0,0.203778,"With a median follow-up of 13 months, 12-month progression-free survival was 100% for patients receiving concomitant treatment and 98% (95% CI, 95%-100%) for patients receiving sequential therapy.
","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Bröckelmann', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Goergen', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keller', 'Affiliation': 'Klinikum Rechts der Isar der TU München, Internal Medicine III, Munich, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Meissner', 'Affiliation': 'Medicine V, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Ordemann', 'Affiliation': 'University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Teresa V', 'Initials': 'TV', 'LastName': 'Halbsguth', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine II, Goethe University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sasse', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sökler', 'Affiliation': 'University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kerkhoff', 'Affiliation': 'Medizinische Klinik A, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Mathas', 'Affiliation': 'Division of Hematology, Oncology, and Tumor Immunology, Charité-Universitätsmedizin Berlin and Max-Delbrück-Center for Molecular Medicine, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Department of Hematology, University Hospital of Essen, Essen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bormann', 'Affiliation': 'Medical Department I, Klinikum Bremen-Mitte, Bremen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Mettler', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'von Tresckow', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Baues', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rosenwald', 'Affiliation': 'Institute of Pathology, University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Department of Hematopathology, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Kobe', 'Affiliation': 'German Hodgkin Study Group, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borchmann', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Engert', 'Affiliation': 'Faculty of Medicine and University Hospital of Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf, University of Cologne, Cologne, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0750']
23,32358836,Cost-effectiveness evaluation of the PROPPR trial transfusion protocols.,"BACKGROUND


There have been no prior investigations of the cost effectiveness of transfusion strategies for trauma resuscitation. The Pragmatic, Randomized, Optimal Platelet and Plasma Ratios (PROPPR) study was a Phase III multisite, randomized trial in 680 subjects comparing the efficacy of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with the 1:1:2 ratio. We hypothesized that 1:1:1 transfusion results in an acceptable incremental cost-effectiveness ratio, when estimated using patients' age-specific life expectancy and cost of care during the 30-day PROPPR trial period.
STUDY DESIGN AND METHODS


International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights. We used a decision tree analysis, combined with standard costs and estimated years of expected survival to determine the cost effectiveness of the two treatments.
RESULTS


The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006). For every 100 patients treated in the 1:1:1 group, eight more achieved hemostasis than in the 1:1:2 group. At 30 days, the total hospital cost per 100 patients was $5.6 million in the 1:1:1 group compared with $5.0 million in the 1:1:2 group. For each 100 patients, the 1:1:1 group had 218.5 more years of life expectancy. This was at a cost of $2994 per year gained.
CONCLUSION


The 1:1:1 transfusion ratio in severely injured hemorrhaging trauma patients is a very cost-effective strategy for increasing hemostasis and decreasing trauma deaths.",2020,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"['severely injured hemorrhaging trauma patients', '680 subjects', 'International Classification of Diseases, Ninth Revision codes were prospectively collected, and subjects were matched 1:2 to subjects in the Healthcare Utilization Program State Inpatient Data to estimate cost weights']",[],"['hemostasis', 'overall costs', 'hemorrhagic death', 'total hospital cost', 'life expectancy']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",680.0,0.0809202,The 1:1:1 group had higher overall costs for the blood products but were more likely to achieve hemostasis and decreased hemorrhagic death by 24 hours (p = 0.006).,"[{'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Callcut', 'Affiliation': 'Division of General Surgery, Department of Surgery, School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Kit N', 'Initials': 'KN', 'LastName': 'Simpson', 'Affiliation': 'Department of Healthcare Leadership & Management, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baraniuk', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': 'Center for Translational Injury Research and Department of Surgery, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Tilley', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'Division of Acute Care Surgery, Department of Surgery, Center for Injury Science, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transfusion,['10.1111/trf.15784']
24,32367416,Impact of spectral body imaging in patients suspected for occult cancer: a prospective study of 503 patients.,"OBJECTIVES


To investigate the diagnostic impact and performance of spectral dual-layer detector CT in the detection and characterization of cancer compared to conventional CE-CT.
METHODS


In a national workup program for occult cancer, 503 patients (286 females and 217 males) were prospectively enrolled for a contrast-enhanced spectral CT scan. The readings were performed with and without spectral data available. A minimum of 3 months between interpretations was implemented to minimize recall bias. The sequence of reads for the individual patient was randomized. Readers were blinded for patient identifiers and clinical outcome. Two radiologists with 9 and 33 years of experience performed the readings in consensus. If disagreement, a third radiologist with 11 years of experience determined the outcome of the reading RESULTS: Significantly more cancer findings were identified on the spectral reading. In 73 cases of proven cancer, we found a sensitivity of 89% vs 77% and a specificity of 77% vs 83% on spectral CT compared to conventional CT. A slight increase in reading time in spectral images of 82 s was found (382 vs 300, p < 0.001). For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries. And adding the spectral information to the reading gave a decrease in follow-up examination for diagnostic certainty (0.25 vs 0.81 per reading, p < 0.001).
CONCLUSION


The use of contrast-enhanced spectral CT increases the confidence of the radiologists in correct characterization of various lesions and minimizes the need for supplementary examinations.
KEY POINTS


• Spectral CT is associated with a higher sensitivity, but a slightly lower specificity compared to conventional CT. • Spectral CT increases the confidence of the radiologists. • The need for supplementary examinations is decreased, with only a slight increase in reading times.",2020,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","['503 patients', '503 patients (286 females and 217 males', 'patients suspected for occult cancer']","['contrast-enhanced spectral CT', 'spectral dual-layer detector CT', 'spectral body imaging']","['diagnostic certainty', 'reading time in spectral images', 'reading times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",503.0,0.0300193,"For all cystic lesions, the perceived diagnostic certainty increased from 30% being completely certain to 96% most pronounced in the kidney, liver, thyroid, and ovaries.","[{'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Herlev and Gentofte, Gentofte Hospitalsvej 1, 2900, Hellerup, Denmark. Michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Dyveke', 'Initials': 'D', 'LastName': 'Ebbesen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Thygesen', 'Affiliation': 'Department of Clinical Engineering, Central Denmark Region, Nørrebrogade 44, Building 2A, Aarhus, 8000, Denmark.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kruis', 'Affiliation': 'Philips Medical Systems, Clinical Science, CT, Veenpluis 4-6, Best, 5684, The Netherlands.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Radiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, Aarhus, 8200, Denmark.'}]",European radiology,['10.1007/s00330-020-06878-7']
25,32356084,Is Essentialism Essential? Reducing Homonegative Prejudice by Targeting Diverse Sexual Orientation Beliefs.,"We conducted an experiment to assess whether targeting multiple beliefs about sexual orientation (SO) may be more effective in reducing homonegativity than focusing only on beliefs about its biogenetic origins. Participants (116 women, 85 men) were randomly assigned to one of three treatment conditions or a control condition. Those in the treatment conditions read essays summarizing: (1) research suggesting SO has biogenetic origins, (2) research suggesting SO is socially constructed and refuting beliefs about the discreteness, homogeneity, and informativeness of SO categories; or (3) research suggesting SO is biogenetic and research suggesting SO categories are socially constructed and not necessarily discrete, homogenous, or informative. We predicted participants in the conditions that targeted multiple beliefs related to the social construction of SO, not just its biogenetic origins, would exhibit the strongest reductions in beliefs about the discreteness, homogeneity, and informativeness of SO categories, and in homonegativity. We also predicted these participants would exhibit the greatest increases in support for gay and lesbian civil rights. We observed hypothesized shifts in SO beliefs across all experimental conditions. While there was a small main effect of time on homonegative prejudice, there was no main effect of condition and no changes in support for gay and lesbian civil rights. However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction. Implications for more comprehensive educational and social interventions designed to promote social justice for sexual minorities are discussed.",2020,"However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction.","['Participants (116 women, 85 men']",[],[],"[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],[],116.0,0.0209656,"However, post hoc analyses suggested the two conditions addressing social constructionist beliefs accounted for most of the observed prejudice reduction.","[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Fry', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Grzanka', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA. patrick.grzanka@utk.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Miles', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}, {'ForeName': 'Elliott N', 'Initials': 'EN', 'LastName': 'DeVore', 'Affiliation': 'Department of Psychology, University of Tennessee, Knoxville, 1404 Circle Drive, Knoxville, TN, 37996, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01706-x']
26,32369102,Overlap Weighting: A Propensity Score Method That Mimics Attributes of a Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.167188,,"[{'ForeName': 'Laine E', 'Initials': 'LE', 'LastName': 'Thomas', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}]",JAMA,['10.1001/jama.2020.7819']
27,32310271,Effect of Neonatal Outcome Estimates on Decision-Making Preferences of Mothers Facing Preterm Birth: A Randomized Clinical Trial.,,2020,,['Mothers Facing Preterm Birth'],[],[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",[],[],,0.161577,,"[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kidszun', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Department of Neonatology, Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Matheisl', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Department of Neonatology, Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Tippmann', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Department of Neonatology, Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Inthorn', 'Affiliation': 'Center for Health Care Ethics, Hannover, Germany.'}, {'ForeName': 'Seyed Hamidreza', 'Initials': 'SH', 'LastName': 'Mahmoudpour', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology, and Informatics, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Norbert W', 'Initials': 'NW', 'LastName': 'Paul', 'Affiliation': 'Institute for the History, Philosophy, and Ethics of Medicine, Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mildenberger', 'Affiliation': 'Center for Pediatric and Adolescent Medicine, Department of Neonatology, Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0235']
28,32359843,Long-term Visual Outcomes after Release from Protocol in Patients who Participated in the Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) Trial.,"PURPOSE


To describe visual outcomes, frequency of treatment and monitoring visits, and anti-vascular endothelial growth factor drugs used in usual care in participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD) was initiated with bevacizumab or ranibizumab.
DESIGN


Multicenter cohort study up to 7 years after trial exit.
PARTICIPANTS


Patients enrolled in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial; after excluding participants from 2 sites and who died or withdrew during the trial, 537 were included in this follow-up cohort.
METHODS


Data were collected between May 26, 2016, and August 24, 2017. Distance visual acuity (DVA) (letters read) in both eyes and treatments for nAMD administered to either eye at all usual care visits were extracted from medical records of all participants until the point of data collection (duration of study eye monitoring).
MAIN OUTCOME MEASURES


Rate of change of DVA during active surveillance of the study eye (study eye monitoring), estimated using a multivariable linear random effects model. Other outcome measures were visit and treatment frequency and switches in anti-vascular endothelial growth factor (VEGF) drug.
RESULTS


Data were obtained for 99% (532/537) of eligible participants. The median duration of study eye monitoring after IVAN exit was 3.3 years (interquartile range [IQR], 1.3-4.7), and median DVA was 58.0 letters (IQR, 34.0-73.0). Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year. Injection rate did not influence the rate of change in DVA after adjusting for key covariates. After IVAN exit, 174 participants (32%) received no treatment; 332 of 358 (93%) were treated first with ranibizumab, 78 (23%) of whom switched to aflibercept. The DVA was similar among participants who switched or did not switch at the end of study monitoring.
CONCLUSIONS


Approximately 5 years after the IVAN study finished, with unprecedented completeness of follow-up for such a trial, the trajectory of functional decline in the study eye was shown to be greater than that previously reported for incomplete trial cohorts. Anti-VEGF injection rates and treatment switches were not important factors in determining visual acuity outcomes.",2020,"Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year.","['participants who switched or did not switch at the end of study monitoring', 'Patients who Participated in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) Trial', 'Multicenter cohort study up to 7 years after trial exit', 'Data were collected between May 26, 2016, and August 24, 2017', 'Patients enrolled in the Inhibition of VEGF in Age-related choroidal Neovascularisation (IVAN) trial; after excluding participants from 2 sites and who died or withdrew during the trial, 537 were included in this follow-up cohort', 'participants who exited a trial in which treatment for neovascular age-related macular degeneration (nAMD']","['bevacizumab or ranibizumab', 'ranibizumab', 'aflibercept']","['Distance visual acuity (DVA) (letters read', 'rate of change in DVA', 'visit and treatment frequency and switches in anti-vascular endothelial growth factor (VEGF) drug', 'median duration of study eye monitoring after IVAN exit', 'visual acuity outcomes', 'Rate of change of DVA during active surveillance of the study eye (study eye monitoring', 'Injection rate', 'median DVA']","[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1283169', 'cui_str': 'Monitoring - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",537.0,0.324775,"Study eye DVA deteriorated by 4.3 (95% confidence interval [CI], 3.7-4.9) letters per year.","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Katherine Alyson', 'Initials': 'KA', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland. Electronic address: u.chakravarthy@qub.ac.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2020.03.020']
29,32374352,Effect of a Face-Aging Mobile App-Based Intervention on Skin Cancer Protection Behavior in Secondary Schools in Brazil: A Cluster-Randomized Clinical Trial.,"Importance


Because exposure to UV radiation early in life is an important risk factor for melanoma development, reducing UV exposure in children and adolescents is of paramount importance. New interventions are urgently required.
Objective


To determine the effect of the free face-aging mobile app Sunface on the skin cancer protection behavior of adolescents.
Design, Setting, and Participants


This cluster-randomized clinical trial included a single intervention and a 6-month follow-up from February 1 to November 30, 2018. Randomization was performed on the class level in 52 school classes within 8 public secondary schools (grades 9-12) in Itauna, Southeast Brazil. Data were analyzed from May 1 to October 10, 2019.
Interventions


In a classroom seminar delivered by medical students, adolescents' selfies were altered by the app to show UV effects on their future faces and were shown in front of their class, accompanied by information about UV protection. Information about relevant parameters was collected via anonymous questionnaires before and 3 and 6 months after the intervention.
Main Outcomes and Measures


The primary end point of the study was the difference in daily sunscreen use at 6 months of follow-up. Secondary end points included the difference in daily sunscreen use at 3 months of follow-up, at least 1 skin self-examination within 6 months, and at least 1 tanning session in the preceding 30 days. All analyses were predefined and based on intention to treat. Cluster effects were taken into account.
Results


Participants included 1573 pupils (812 girls [51.6%] and 761 boys [48.4%]; mean [SD] age, 15.9 [1.3] years) from 52 school classes. Daily sunscreen use increased from 110 of 734 pupils (15.0%) to 139 of 607 (22.9%; P < .001) at the 6-month follow-up in the intervention group. The proportion of pupils performing at least 1 skin self-examination in the intervention group rose from 184 of 734 (25.1%) to 300 of 607 (49.4%; P < .001). Use of tanning decreased from 138 of 734 pupils (18.8%) to 92 of 607 (15.2%; P = .04). No significant changes were observed in the control group. The intervention was more effective for female students (number needed to treat for the primary end point: 8 for girls and 31 for boys).
Conclusions and Relevance


These findings suggest that interventions based on face-aging apps may increase skin cancer protection behavior in Brazilian adolescents. Further studies are required to maximize the effect and to investigate the generalizability of the effects.
Trial Registration


ClinicalTrials.gov Identifier: NCT03178240.",2020,"The intervention was more effective for female students (number needed to treat for the primary end point: 8 for girls and 31 for boys).
","['Secondary Schools in Brazil', 'Brazilian adolescents', 'Results\n\n\nParticipants included 1573 pupils (812 girls [51.6%] and 761 boys [48.4%]; mean [SD] age, 15.9 [1.3] years) from 52 school classes', '52 school classes within 8 public secondary schools (grades 9-12) in Itauna, Southeast Brazil', 'female students (number needed to treat for the primary end point: 8 for girls and 31 for boys', 'adolescents']","['Face-Aging Mobile App-Based Intervention', 'free face-aging mobile app Sunface']","['Daily sunscreen use', 'Skin Cancer Protection Behavior', 'proportion of pupils performing at least 1 skin self-examination', 'daily sunscreen use', 'skin cancer protection behavior']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038818', 'cui_str': 'Sunscreen agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}]",,0.0597811,"The intervention was more effective for female students (number needed to treat for the primary end point: 8 for girls and 31 for boys).
","[{'ForeName': 'Titus J', 'Initials': 'TJ', 'LastName': 'Brinker', 'Affiliation': 'Department of Dermatology, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Bianca Lisa', 'Initials': 'BL', 'LastName': 'Faria', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Olber Moreira', 'Initials': 'OM', 'LastName': 'de Faria', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Klode', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jochen S', 'Initials': 'JS', 'LastName': 'Utikal', 'Affiliation': 'Department of Dermatology, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Mons', 'Affiliation': 'Cancer Prevention Unit, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krieghoff-Henning', 'Affiliation': 'Department of Dermatology, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Oscar Campos', 'Initials': 'OC', 'LastName': 'Lisboa', 'Affiliation': 'School of Medicine, Federal University of Ouro Preto, Ouro Preto, Brazil.'}, {'ForeName': 'Ana Carla Cruz', 'Initials': 'ACC', 'LastName': 'Oliveira', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Henrique Augusto', 'Initials': 'HA', 'LastName': 'Lino', 'Affiliation': 'School of Medicine, University of Itauna, Itauna, Brazil.'}, {'ForeName': 'Breno', 'Initials': 'B', 'LastName': 'Bernardes-Souza', 'Affiliation': 'School of Medicine, Federal University of Ouro Preto, Ouro Preto, Brazil.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.0511']
30,32374371,Association of Surgical Skill Assessment With Clinical Outcomes in Cancer Surgery.,"Importance


Complex surgical interventions are inherently prone to variation yet they are not objectively measured. The reasons for outcome differences following cancer surgery are unclear.
Objective


To quantify surgical skill within advanced laparoscopic procedures and its association with histopathological and clinical outcomes.
Design, Setting, and Participants


This analysis of data and video from the Australasian Laparoscopic Cancer of Rectum (ALaCaRT) and 2-dimensional/3-dimensional (2D3D) multicenter randomized laparoscopic total mesorectal excision trials, which were conducted at 28 centers in Australia, the United Kingdom, and New Zealand, was performed from 2018 to 2019 and included 176 patients with clinical T1 to T3 rectal adenocarcinoma 15 cm or less from the anal verge. Case videos underwent blinded objective analysis using a bespoke performance assessment tool developed with a 62-international expert Delphi exercise and workshop, interview, and pilot phases.
Interventions


Laparoscopic total mesorectal excision undertaken with curative intent by 34 credentialed surgeons.
Main Outcomes and Measures


Histopathological (plane of mesorectal dissection, ALaCaRT composite end point success [mesorectal fascial plane, circumferential margin, ≥1 mm; distal margin, ≥1 mm]) and 30-day morbidity. End points were analyzed using surgeon quartiles defined by tool scores.
Results


The laparoscopic total mesorectal excision performance tool was produced and shown to be reliable and valid for the specialist level (intraclass correlation coefficient, 0.889; 95% CI, 0.832-0.926; P < .001). A substantial variation in tool scores was recorded (range, 25-48). Scores were associated with the number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications. Upper quartile-scoring surgeons obtained excellent results compared with the lower quartile (mesorectal fascial plane: 93% vs 59%; number needed to treat [NNT], 2.9, P = .002; ALaCaRT end point success, 83% vs 58%; NNT, 4; P = .03; 30-day morbidity, 23% vs 50%; NNT, 3.7; P = .03).
Conclusions and Relevance


Intraoperative surgical skill can be objectively and reliably measured in complex cancer interventions. Substantial variation in technical performance among credentialed surgeons is seen and significantly associated with clinical and pathological outcomes.",2020,"Scores were associated with the number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications.","['Cancer Surgery', '28 centers in Australia, the United Kingdom, and New Zealand, was performed from 2018 to 2019 and included 176 patients with clinical T1 to T3 rectal adenocarcinoma 15 cm or less from the anal verge']",['Laparoscopic total mesorectal excision undertaken with curative intent by 34 credentialed surgeons'],"['30-day morbidity', 'Measures\n\n\nHistopathological (plane of mesorectal dissection, ALaCaRT composite end point success [mesorectal fascial plane, circumferential margin, ≥1 mm; distal margin, ≥1 mm]) and 30-day morbidity', 'number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",176.0,0.298896,"Scores were associated with the number of intraoperative errors, plane of mesorectal dissection, and short-term patient morbidity, including the number and severity of complications.","[{'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Curtis', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, England.'}, {'ForeName': 'Jake D', 'Initials': 'JD', 'LastName': 'Foster', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, England.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Miskovic', 'Affiliation': ""St Mark's Hospital, Northwick Park, Harrow, England.""}, {'ForeName': 'Chris S B', 'Initials': 'CSB', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hewett', 'Affiliation': 'Department of Surgery, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Abbott', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, England.'}, {'ForeName': 'Andrew R L', 'Initials': 'ARL', 'LastName': 'Stevenson', 'Affiliation': 'Faculty of Medical and Biomedical Sciences, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Nader K', 'Initials': 'NK', 'LastName': 'Francis', 'Affiliation': 'Department of General Surgery, Yeovil District Hospital National Health Service Foundation Trust, Yeovil, England.'}]",JAMA surgery,['10.1001/jamasurg.2020.1004']
31,32372161,Safety and efficacy of hypertonic saline solution (5%) versus placebo in the treatment of postoperative corneal edema after uneventful phacoemulsification: a randomized double-blind study.,"PURPOSE


To evaluate safety and efficacy of hypertonic saline solution administration after uneventful cataract surgery.
DESIGN


Prospective double-blind randomized study METHODS: In total, 183 eyes of 183 patients undergoing phacoemulsification were randomly allocated into two equal groups. Treatment group (TG) subjects received single-dose hypertonic (NaCl 5%) solution 4 times daily for 14 days, while placebo group (PG) received single dose of normal saline solution (0.9%) at the same frequency in addition to ordinary postoperative treatment. All patients underwent assessment of central corneal thickness (CCT), endothelial cell density (ECD), best-corrected visual acuity (BCVA), clinical staging of postoperative corneal edema and questionnaire regarding the procedure success and impact on patient's life. Measurements were taken at baseline and 1, 4, 9 and 30 days following surgery.
RESULTS


CCT increased by 134.67 ± 94.51 μm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58). Corneal edema showed a significant recession in TG compared to PG on day 4, in terms of both pachymetry (10.73% vs 7.39%, p = 0.004), BCVA (BCVA TG  = 0.64 ± 0.24 [logMAR TG  = 0.25 ± 0.3], BCVA PG  = 0.56 ± 0.23 [logMAR PG  = 0.33 ± 0.3], p = 0.04) and clinical staging (p = 0.02). Similar results were recorded on postoperative day 9 in subjects demonstrating marked corneal edema on the first postoperative day. Endothelial cell loss showed no statistically significant difference between study groups (p = 0.48). No adverse events were recorded in relation to treatment. More patients in the TG (92.4% vs 57.1% in the PG) reported a subjectively clear vision 1 week postoperatively (p = 0.04).
CONCLUSION


The use of 5% hypertonic saline solution is found to be a safe and effective adjunct in the management of postoperative corneal edema after uneventful phacoemulsification, achieving rapid corneal clearance and expediting a good visual outcome, especially in cases with marked postoperative edema.",2020,"RESULTS


CCT increased by 134.67 ± 94.51 μm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58).","['In total, 183 eyes of 183 patients undergoing phacoemulsification', 'postoperative corneal edema after uneventful phacoemulsification']","['single-dose hypertonic (NaCl 5%) solution 4 times daily for 14\xa0days, while placebo group (PG) received single dose of normal saline solution', 'hypertonic saline solution', 'placebo']","['subjectively clear vision', 'postoperative corneal edema', 'Safety and efficacy', 'Corneal edema', 'adverse events', 'Endothelial cell loss', 'corneal edema', ""central corneal thickness (CCT), endothelial cell density (ECD), best-corrected visual acuity (BCVA), clinical staging of postoperative corneal edema and questionnaire regarding the procedure success and impact on patient's life""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]","[{'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",183.0,0.37664,"RESULTS


CCT increased by 134.67 ± 94.51 μm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58).","[{'ForeName': 'Argyrios', 'Initials': 'A', 'LastName': 'Tzamalis', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece. argyriostzamalis@yahoo.com.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dermenoudi', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Asterios', 'Initials': 'A', 'LastName': 'Diafas', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Oustoglou', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Matsou', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Ziakas', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsinopoulos', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical School, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloniki, Greece.'}]",International ophthalmology,['10.1007/s10792-020-01395-4']
32,32311184,Efficacy of Buzzy ®  on pain and anxiety during catheterization in children.,"BACKGROUND


The use of a peripheral intravenous cannula is a common clinical practice, and it is known to be a major source of pain and anxiety in children. The aim of this study was to examine the effect of the use of the Buzzy ®  on pain and anxiety in children during peripheral cannula application.
METHODS


The research sample consisted of 60 children between the ages of 8 and 16. For children in the experimental group, external cold and vibration were applied by means of the Buzzy ®  device. Before and during the peripheral intravenous cannula procedure, the levels of fear and anxiety relating to the procedure of the child patients in both the experimental and control groups were assessed by the children themselves and by an independent observer. Immediately after the vein entry procedure had been carried out, the level of pain felt by the children was determined.
RESULTS


The results of the statistical analysis showed no statistically significant difference between the anxiety levels of the groups before and after the procedure (P > 0.05). The results of the statistical analysis also showed no statistically significant difference between the postprocedural mean pain scores of the children as reported by the children themselves and by the observer (P > 0.05).
CONCLUSIONS


In this study, unlike most studies in the literature, the conclusion was reached that the use of the Buzzy ®  to reduce pain and anxiety during the application of a peripheral intravenous cannula in children was not effective.",2020,The results of the statistical analysis showed no statistically significant difference between anxiety levels of the groups before and after the procedure (p>0.05).,"['60 children between the ages of 8 and 16', 'children', 'Children', 'children during peripheral cannula application']",['Buzzy®'],"['levels of fear and anxiety', 'procedural mean pain scores', 'level of pain felt', 'pain and anxiety', 'Pain and Anxiety', 'anxiety levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0185125', 'cui_str': 'Application'}]",[],"[{'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",60.0,0.0340149,The results of the statistical analysis showed no statistically significant difference between anxiety levels of the groups before and after the procedure (p>0.05).,"[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Bursa Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Nurcan', 'Initials': 'N', 'LastName': 'Özyazıcıoğlu', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Bursa Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Gülseren', 'Initials': 'G', 'LastName': 'Çıtak Tunç', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Bursa Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Ayla İrem', 'Initials': 'Aİ', 'LastName': 'Aydın', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Bursa Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Atak', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Bursa Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Duygulu', 'Affiliation': ""Children's Diseases Clinic, Bursa Dörtçelik Children's Hospital, Bursa, Turkey.""}, {'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Demirtaş', 'Affiliation': ""Children's Diseases Clinic, Bursa Dörtçelik Children's Hospital, Bursa, Turkey.""}]",Pediatrics international : official journal of the Japan Pediatric Society,['10.1111/ped.14257']
33,32299086,Young adults born preterm below 30 weeks of gestation and risk of QT tract prolongation.,,2020,,['Young adults born preterm below 30 weeks of gestation and risk of QT tract prolongation'],[],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",[],[],,0.0253211,,"[{'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Bassareo', 'Affiliation': ""University College of Dublin, Mater Misericordiae University Hospital and Our Lady's Children's Hospital Crumlin, Dublin, Ireland. piercard@inwind.it.""}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Fanos', 'Affiliation': 'Neonatal Intensive Care Unit, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mercuro', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}]",Pediatric research,['10.1038/s41390-020-0904-8']
34,32365303,Addition of pectin-alginate to a carbohydrate beverage does not maintain gastrointestinal barrier function during exercise in hot-humid conditions better than carbohydrate ingestion alone.,"The objective of this study was to compare the effects of consuming a 16% maltodextrin+fructose+pectin-alginate (MAL+FRU+PEC+ALG) drink against a nutrient-matched maltodextrin+fructose (MAL+FRU) drink on enterocyte damage and gastrointestinal permeability after cycling in hot and humid conditions. Fourteen recreational cyclists (7 men) completed 3 experimental trials in a randomized placebo-controlled design. Participants cycled for 90 min (45% maximal aerobic capacity) and completed a 15-min time-trial in hot (32 °C) humid (70% relative humidity) conditions. Every 15 min, cyclists consumed 143 mL of either ( i ) water; ( ii ) MAL+FRU+PEC+ALG (90 g·h -1  CHO/16%  w/v ); or ( iii ) a ratio-matched MAL+FRU drink (90 g·h -1  CHO/16%  w/v ). Blood was sampled before and after exercise and gastrointestinal (GI) permeability, which was determined by serum measurements of intestinal fatty acid binding protein (I-FABP) and the percent ratio of lactulose (5 g) to rhamnose (2 g) recovered in postexercise urine. Compared with water, I-FABP decreased by 349 ± 67pg·mL -1  with MAL+FRU+PEC+ALG ( p  = 0.007) and by 427 ± 56 pg·mL -1  with MAL+FRU ( p  = 0.02). GI permeability was reduced in both the MAL+FRU+PEC+ALG (by 0.019 ± 0.01,  p  = 0.0003) and MAL+FRU (by 0.014 ± 0.01,  p  = 0.002) conditions relative to water. In conclusion, both CHO beverages attenuated GI barrier damage to a similar extent relative to water. No metabolic, cardiovascular, thermoregulatory, or performance differences were observed between the CHO beverages.  Novelty  Consumption of multiple-transportable CHO, with or without hydrogel properties, preserves GI barrier integrity and reduces enterocyte damage during prolonged cycling in hot-humid conditions.",2020,"Compared to WATER, IFABP decreased by 349±67pg.mL-1 with MAL+FRU+PEC+ALG (p=0.007), and by 427±56pg.mL-1 with MAL+FRU (p=0.02).",['Fourteen recreational cyclists (7 men'],"['MAL+FRU+PEC+ALG', 'maltodextrin+fructose+pectin alginate (MAL+FRU+PEC+ALG) drink against a nutrient matched maltodextrin-fructose (MAL+FRU) drink', 'pectin-alginate', 'placebo']","['enterocyte damage and gastrointestinal permeability', 'No metabolic, cardiovascular, thermoregulatory or performance differences', 'GI permeability', 'GI barrier damage', 'MAL+FRU', 'IFABP', 'gastrointestinal barrier function', 'gastrointestinal (GI) permeability determined by serum measurements of intestinal fatty acid-binding protein (IFABP']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0030744', 'cui_str': 'Pectin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0682610', 'cui_str': 'Enterocytes'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}]",,0.0791395,"Compared to WATER, IFABP decreased by 349±67pg.mL-1 with MAL+FRU+PEC+ALG (p=0.007), and by 427±56pg.mL-1 with MAL+FRU (p=0.02).","[{'ForeName': 'Tessa R', 'Initials': 'TR', 'LastName': 'Flood', 'Affiliation': 'Institute of Sport, Occupational Performance Research Group, University of Chichester, West Sussex, PO10 6PE, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Montanari', 'Affiliation': 'Institute of Sport, Occupational Performance Research Group, University of Chichester, West Sussex, PO10 6PE, UK.'}, {'ForeName': 'Marley', 'Initials': 'M', 'LastName': 'Wicks', 'Affiliation': 'Institute of Sport, Occupational Performance Research Group, University of Chichester, West Sussex, PO10 6PE, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Institute of Sport, Occupational Performance Research Group, University of Chichester, West Sussex, PO10 6PE, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Sharp', 'Affiliation': 'Institute of Sport, Occupational Performance Research Group, University of Chichester, West Sussex, PO10 6PE, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Taylor', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, LE11 3TU, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Kuennen', 'Affiliation': 'Department of Exercise Science, High Point University, High Point, NC 27268, USA.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Institute of Sport, Occupational Performance Research Group, University of Chichester, West Sussex, PO10 6PE, UK.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0118']
35,32374283,Effect of a rapid e-learning module and brief interprofessional simulation event on medical and nursing student collaborative attitudes and behaviors.,"Objectives Undergraduate nursing and first-year medical students participated in a brief, scenario-based, interprofessional event. The experimental group only was provided an innovative, rapid e-learning instructional module focused on interprofessional roles/responsibilities and communication prior to the event. Methods Pre-post attitudes toward physician-nurse collaboration were surveyed, and collaborative behaviors were observed during the event. Results For the experimental group, a statistically significant (p<0.05) attitude improvement was found between pre-post e-learning module scores as well as pre-e-learning module and post-simulation event scores. For the control group, a statistically significant (p=0.001) attitude improvement was found between pre-post simulation event scores. No statistically significant differences in team collaborative behaviors were observed between experimental and control. Conclusions The combination of module and simulation event was not a more effective option than the event alone. As both interventions present unique challenges in regards to technology and facility requirements, having multiple effective intervention options will be of benefit to educational institutions.",2020,"Results For the experimental group, a statistically significant (p<0.05) attitude improvement was found between pre-post e-learning module scores as well as pre-e-learning module and post-simulation event scores.","['Objectives Undergraduate nursing and first-year medical students participated in a brief, scenario-based, interprofessional event']",['rapid e-learning module and brief interprofessional simulation'],"['team collaborative behaviors', 'attitude improvement']","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0130626,"Results For the experimental group, a statistically significant (p<0.05) attitude improvement was found between pre-post e-learning module scores as well as pre-e-learning module and post-simulation event scores.","[{'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Visker', 'Affiliation': 'Minnesota State University Mankato, Mankato, MN, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Welker', 'Affiliation': 'Truman State University, Kirksville, MO, USA.'}, {'ForeName': 'Darson', 'Initials': 'D', 'LastName': 'Rhodes', 'Affiliation': 'SUNY Brockport School of Health and Human Performance, Brockport, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Forsyth', 'Affiliation': 'Minnesota State University Mankato, Mankato, MN, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Melvin', 'Affiliation': 'Truman State University, Kirksville, MO, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Cox', 'Affiliation': 'Truman State University, HES, 2123 Pershing Building - HES, 100 E Normal St, Truman State University, Kirksville, MO, USA.'}]",International journal of nursing education scholarship,['10.1515/ijnes-2019-0122']
36,32372186,The efficacy of the prenatal administration of Lactobacillus reuteri LR92 DSM 26866 on the prevention of infantile colic: a randomized control trial.,"Infantile colic is a functional gastrointestinal disease of the infancy that its cause has not yet been properly identified. It leads to severe discomfort in the infants and anxiety in their mothers. Probiotics have recently been recommended as an effective treatment for the improvement of infantile colic. The objective of this study is to determine the role of prenatal administration of Lactobacillus reuteri (L. reuteri) LR92 DSM 26866 on the occurrence of infantile colic. This double-blinded, placebo-controlled, randomized trial was conducted with healthy pregnant women from December 2017 to December 2018 in Isfahan, Iran. A total of 145 patients was included in this study. The case group consisted of 87 pregnant women, who received daily doses of 1 × 10 8  colony-forming units of live L. reuteri LR92 DSM 26866, and the control group with 88 pregnant women received the placebo (containing 9% glucose solutions) for the last 4 weeks of pregnancy. Mothers and their infants in both groups did not have significant differences in anthropometric indices, and the infants' feeding pattern. Infants born to both groups of mothers followed for 5 months on signs and symptoms of colic with the repetitive examination by a blinded pediatrics assistant to record the occurrence of colic and its grading. Mothers who received placebo were 2.36 times more likely to have infants exhibiting infantile colic than mothers in the L. reuteri LR92 DSM 26866 group (CI 95%, 1.18-4.73). Using Mann-Whitney U test, the Mean (SD) of colic severity was significantly lower in the intervention group (p = 0.01). The frequency of colic and its higher grades were significantly lower in the intervention group (p = 0.03 for the presence of colic and p = 0.01 for high grades of colic). The frequency of colic presence and its different grades according to mothers' delivery mode and infant feeding patterns were not different between the two groups (p > 0.05).Conclusion: Maternal prenatal supplementation with probiotic L. reuteri LR92 DSM 26866 during the last 4 weeks of pregnancy can prevent the occurrence and reduce the severity of infantile colic. What is Known • Lactobacillus reuteri LR92 DSM 26866 is effective in improving the symptoms of infantile colic. What is New • Prenatal administration of Lactobacillus Reuteri LR92 DSM 26866 can prevent the occurrence of infantile colic or reduce its severity.",2020,The frequency of colic presence and its different grades according to mothers' delivery mode and infant feeding patterns were not different between the two groups (p > 0.05).Conclusion: Maternal prenatal supplementation with probiotic L. reuteri LR92 DSM 26866 during the last 4 weeks of pregnancy can prevent the occurrence and reduce the severity of infantile colic.,"['healthy pregnant women from December 2017 to December 2018 in Isfahan, Iran', 'infantile colic', '88 pregnant women received the', '145 patients was included in this study', '87 pregnant women']","['Lactobacillus reuteri LR92 DSM', 'probiotic L. reuteri LR92 DSM', 'Lactobacillus reuteri (L. reuteri) LR92 DSM', 'Lactobacillus Reuteri LR92 DSM', 'daily doses of 1\u2009×\u200910 8  colony-forming units of live L. reuteri LR92 DSM', 'placebo (containing 9% glucose solutions', 'placebo']","['frequency of colic', 'Mean (SD) of colic severity', 'frequency of colic presence', 'signs and symptoms of colic', 'severity of infantile colic', 'infants exhibiting infantile colic']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0266836', 'cui_str': 'Infantile colic'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0232488', 'cui_str': 'Abdominal colic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0266836', 'cui_str': 'Infantile colic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]",87.0,0.0762949,The frequency of colic presence and its different grades according to mothers' delivery mode and infant feeding patterns were not different between the two groups (p > 0.05).Conclusion: Maternal prenatal supplementation with probiotic L. reuteri LR92 DSM 26866 during the last 4 weeks of pregnancy can prevent the occurrence and reduce the severity of infantile colic.,"[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Pourmirzaiee', 'Affiliation': 'Department of Pediatrics, Imam Hossein Hospital, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Famouri', 'Affiliation': 'Department of Pediatrics, Imam Hossein Hospital, Isfahan, Iran. Famouri@med.mui.ac.ir.'}, {'ForeName': 'Wida', 'Initials': 'W', 'LastName': 'Moazeni', 'Affiliation': 'Department of Pediatrics, Imam Hossein Hospital, Isfahan, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hassanzadeh', 'Affiliation': 'Department of Statistical Sciences, Isfahan University of Medical Science, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hajihashemi', 'Affiliation': 'Department of Obstetrics and Gynecology, Beheshti Hospital, Isfahan, Iran.'}]",European journal of pediatrics,['10.1007/s00431-020-03641-4']
37,32379269,Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT03137121.",2020,"Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.","['30 patients (15 per arm) were enrolled; these included 16 women and 14 men who had a mean (range) age of 63 (39-79) years', 'Eligible participants were outpatients with advanced cancer who had persistent nausea/vomiting without having had chemotherapy or radiotherapy in the prior 14 days', 'patients with advanced cancer', 'July 2017 through April 2019, with analysis conducted in 2019', 'Advanced Cancer-Related Chronic Nausea and/or Vomiting']","['olanzapine', 'Olanzapine', 'placebo']","['nausea and emesis', 'median nausea scores', 'Chronic nausea', 'excess sedation', 'Baseline median nausea scores', 'chronic nausea/vomiting', 'nausea scores', 'Nausea and vomiting', 'nausea numeric rating scores', 'emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3654042', 'cui_str': 'Other antiemetics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",30.0,0.258888,"Correspondingly, patients in the olanzapine arm reported less emesis, less use of other antiemetic drugs, better appetite, less sedation, less fatigue, and better well-being.","[{'ForeName': 'Rudolph M', 'Initials': 'RM', 'LastName': 'Navari', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham.'}, {'ForeName': 'Cameron M', 'Initials': 'CM', 'LastName': 'Pywell', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Dodge', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Costantine', 'Initials': 'C', 'LastName': 'Albany', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1052']
38,32379280,Effect of Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone in Patients With Advanced Colorectal Cancer: The Canadian Cancer Trials Group CO.26 Study.,"Importance


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


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


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


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


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


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


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


ClinicalTrials.gov Identifier: NCT02870920.",2020,Grade 3 or 4 adverse events were significantly more frequent with immunotherapy (75 [64%] patients in the treatment group had at least 1 grade 3 or higher adverse event vs 12 [20%] in the BSC group).,"['if RAS wild-type tumors; regorafenib if available); were aged 18 years or older; had adequate organ function; had Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease', 'Eligible patients had histologically confirmed adenocarcinoma of the colon or rectum', 'advanced refractory colorectal cancer (CRC', 'Patients With Advanced Colorectal Cancer', 'patients with advanced refractory CRC', '180 patients enrolled (121 men [67.2%] and 59 women [32.8%]; median [range] age, 65 [36-87] years), 179 were treated', '27 cancer centers across Canada between August 2016 and June 2017, and data were analyzed on October 18, 2018', '168 of 169 patients with available samples']","['standard systemic therapies (fluoropyrimidines, oxaliplatin, irinotecan, and bevacizumab if appropriate; cetuximab or panitumumab', 'Combined Immune Checkpoint Inhibition vs Best Supportive Care Alone', 'tremelimumab every 28 days for the first 4 cycles plus 1500 mg durvalumab every 28 days, or best supportive care alone (BSC']","['plasma TMB', 'median OS', 'Grade 3 or 4 adverse events', 'microsatellite instability (MSI) and tumor mutation burden (TMB', 'greatest OS benefit', 'overall survival (OS', 'Progression-free survival']","[{'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0338106', 'cui_str': 'Adenocarcinoma of colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C3873157', 'cui_str': 'Every twenty eight days'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",180.0,0.228314,Grade 3 or 4 adverse events were significantly more frequent with immunotherapy (75 [64%] patients in the treatment group had at least 1 grade 3 or higher adverse event vs 12 [20%] in the BSC group).,"[{'ForeName': 'Eric X', 'Initials': 'EX', 'LastName': 'Chen', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, Canada.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Jonker', 'Affiliation': 'The Ottawa Hospital, Ottawa, Canada.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Loree', 'Affiliation': 'BC Cancer, Vancouver, Canada.'}, {'ForeName': 'Hagen F', 'Initials': 'HF', 'LastName': 'Kennecke', 'Affiliation': 'Virginia Mason Medical Center, Seattle.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Berry', 'Affiliation': ""Department of Oncology, Queen's University, Kingston, Canada.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'CHU de Québec-Université, Laval, Canada.'}, {'ForeName': 'Chaudhary E', 'Initials': 'CE', 'LastName': 'Ahmad', 'Affiliation': ""Eastern Health, St John's, Canada.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Goffin', 'Affiliation': 'Juvravinski Cancer Center, Hamilton, Canada.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'Segal Cancer Center, Montreal, Canada.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Harb', 'Affiliation': 'Moncton Hospital, Moncton, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Colwell', 'Affiliation': 'Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Samimi', 'Affiliation': 'Hôpital Sacré-Coeur de Montréal, Montreal, Canada.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Samson', 'Affiliation': 'Sherbrooke University, Sherbrooke, Canada.'}, {'ForeName': 'Tahir', 'Initials': 'T', 'LastName': 'Abbas', 'Affiliation': 'Saskatoon Cancer Center, Saskatoon, Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Aucoin', 'Affiliation': 'Hôpital Cité-de-la-Santé, Laval, Canada.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Aubin', 'Affiliation': ""Centre de recherche du Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Canada.""}, {'ForeName': 'Sheryl L', 'Initials': 'SL', 'LastName': 'Koski', 'Affiliation': 'Cross Cancer Center, Edmonton, Canada.'}, {'ForeName': 'Alice C', 'Initials': 'AC', 'LastName': 'Wei', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, Canada.'}, {'ForeName': 'Nadine M', 'Initials': 'NM', 'LastName': 'Magoski', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Canada.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Canada.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': ""O'Callaghan"", 'Affiliation': 'Canadian Cancer Trials Group, Kingston, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0910']
39,32379288,Facedown Positioning Following Surgery for Large Full-Thickness Macular Hole: A Multicenter Randomized Clinical Trial.,"Importance


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


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


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


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


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


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


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


Isrctn.org Identifier: 12410596.",2020,The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR,"['participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months', 'A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years', 'for Large Full-Thickness Macular Hole', 'All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract']","['facedown or face forward for 8 hours daily for 5 days', 'logMAR', 'Facedown Positioning Following Surgery']","['mean (SD) improvement in best-corrected visual acuity', 'visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25', 'Macular hole closure', 'closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation', 'median National Eye Institute Visual Function Questionnaire 25 score']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0937858', 'cui_str': 'Perflutren'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",185.0,0.352625,The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR,"[{'ForeName': 'Saruban', 'Initials': 'S', 'LastName': 'Pasu', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Zohra', 'Initials': 'Z', 'LastName': 'Zenasni', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Irene A', 'Initials': 'IA', 'LastName': 'Simmonds', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yorston', 'Affiliation': 'Gartnavel Royal Hospital, Glasgow, Scotland.'}, {'ForeName': 'D Alistair H', 'Initials': 'DAH', 'LastName': 'Laidlaw', 'Affiliation': ""St Thomas' Hospital, London, England.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England.'}, {'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Bainbridge', 'Affiliation': 'National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0987']
40,32383277,"Randomized, controlled, participant- and rater-blind trial of pharmacogenomic test-guided treatment versus treatment as usual for major depressive disorder.","BACKGROUND


Cohort and cost-effectiveness studies suggest that measuring variation in genes that influence metabolism of common drugs could improve antidepressant treatment outcomes. Prior randomized trials have yielded inconsistent results.
METHOD


Multicenter randomized double-blind (subject and rater), controlled trial of pharmacogenomic testing among outpatients with nonpsychotic major depressive disorder. Study participants (n = 304) were randomized 1:1 to assay-guided treatment (AGT; N = 151) or treatment-as-usual (TAU; N = 153). Participants and raters were blinded to study arm; unblinded clinicians received results of a pharmacogenomic test and adjusted treatment in light of the test report. Primary outcome was change over 8 weeks in Hamilton Depression Rating Scale (SIGH-D-17).
RESULTS


For the primary comparison of interest, change in SIGH-D-17, no significant difference was detected between AGT and TAU at Week 8 (p = .53). Rates of study completion also did not differ between the arms (AGT 92.7%, TAU 92.2% (χ 2   = 0.03, df = 1, p = .86). Exploratory analyses suggested significantly fewer individuals experienced worsening of depressive symptoms following AGT, and that treatment concordant with assay results was associated with greater likelihood of remission.
CONCLUSION


Pharmacogenomic testing using a panel of pharmacokinetic and pharmacodynamic variants was not associated with significant improvement in the primary efficacy outcome when providers were unconstrained by the assay results. Further investigation is needed to understand the discordance with cost-effectiveness results and among randomized trials.",2020,"Rates of study completion also did not differ between the arms (AGT 92.7%, TAU 92.2% (χ 2   = 0.03, df = ","['Study participants (n\u2009=\u2009304', 'outpatients with nonpsychotic major depressive disorder', 'major depressive disorder']","['assay-guided treatment (AGT; N\u2009=\u2009151) or treatment-as-usual (TAU; N\u2009=\u2009153', 'pharmacogenomic test-guided treatment']","['likelihood of remission', 'depressive symptoms', 'change over 8 weeks in Hamilton Depression Rating Scale (SIGH-D-17']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0425481', 'cui_str': 'Sighing respiration'}]",304.0,0.452012,"Rates of study completion also did not differ between the arms (AGT 92.7%, TAU 92.2% (χ 2   = 0.03, df = ","[{'ForeName': 'Roy H', 'Initials': 'RH', 'LastName': 'Perlis', 'Affiliation': 'Department of Psychiatry and Division of Clinical Research, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dowd', 'Affiliation': 'Clinical Research & Development and Medical Affairs, Genomind, Inc., King of Prussia, Pennsylvania.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry and Division of Clinical Research, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lencz', 'Affiliation': 'Department of Psychiatry, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Krause', 'Affiliation': 'Clinical Research & Development and Medical Affairs, Genomind, Inc., King of Prussia, Pennsylvania.'}]",Depression and anxiety,['10.1002/da.23029']
41,32320009,Effect Size and Blinding in Lumateperone Trial.,,2020,,[],[],[],[],[],[],,0.094324,,"[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Gouse', 'Affiliation': 'Department of Psychiatry, Boston University Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Boston University Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Smith', 'Affiliation': 'Mental Health Service Line, Edith Nourse Rogers Memorial VA Medical Center, Bedford, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0610']
42,32320025,Effect Size and Blinding in Lumateperone Trial-Reply.,,2020,,[],[],[],[],[],[],,0.0776713,,"[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Hassan D', 'Initials': 'HD', 'LastName': 'Lakkis', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Vanover', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0613']
43,32381098,Improvement cues of lesion absorption using the adjuvant therapy of traditional Chinese medicine Qinbudan tablet for retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen.,"BACKGROUND


China is the second highest pulmonary tuberculosis (PTB) burden country worldwide. However, retreatment of PTB has often developed resistance to at least one of the four first-line anti-TB drugs. The cure rate (approximately 50.0-73.3%) and management of retreatment of PTB in China needs to be improved. Qinbudan decoction has been widely used to treat PTB in China since the 1960s. Previously clinical studies have shown that the Qinbudan tablet (QBDT) promoted sputum-culture negative conversion and lesion absorption. However, powerful evidence from a randomized controlled clinical trial is lacking. Therefore, the aim of this study was to compare the efficacy and safety of QBDT as an adjunct therapy for retreatment of PTB.
METHODS


We conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial in China. People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013. The treatment group received an anti-TB regimen and QBDT, and the control group was administered an anti-TB regimen plus placebo. Anti-TB treatment options included isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin for 2 months (2HRZES), followed by isoniazid, rifampicin, ethambutol for 6 months (6HRE), daily for 8 months. Primary outcome was sputum-culture conversion using the MGIT 960 liquid medium method. Secondary outcomes included lung lesion absorption and cavity closure. Adverse events and reactions were observed after treatment. A structured questionnaire was used to record demographic information and clinical symptoms of all subjects. Data analysis was performed by SPSS 25.0 software in the full analysis set (FAS) population.
RESULTS


One hundred eighty-one cases of retreatment PTB were randomly divided into two groups: the placebo group (88 cases) and the QBDT group (93 cases). A total of 166 patients completed the trial and 15 patients lost to follow-up. The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment. A significant 16.6% increase in lesion absorption was observed in the QBDT group when compared with the placebo group (67.7% vs 51.1%; rate difference = 0.17, 95% CI: 0.02-0.31; χ 2  = 5.56, P = 0.02). The intervention and placebo group did not differ in terms of cavity closure (25.5% vs 21.1%; rate difference = 0.04, 95% CI: - 0.21-0.12; χ 2  = 0.27, P = 0.60). Two patients who received chemotherapy and combined QBDT reported pruritus/nausea and vomiting.
CONCLUSIONS


No significant improvement in culture conversion was observed for retreatment PTB with traditional Chinese medicine plus standard anti-TB regimen. However, QBDT as an adjunct therapy significantly promoted lesion absorption, thereby reducing lung injury due to Mycobacterium tuberculosis infection.
TRIAL REGISTRATION


This trial is registered at ClinicalTrials.gov, NCT02313610.",2020,"The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment.","['One hundred eighty-one cases of retreatment PTB', '166 patients completed the trial and 15 patients lost to follow-up', 'retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen', 'People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013']","['chemotherapy and combined QBDT', 'anti-TB regimen and QBDT, and the control group was administered an anti-TB regimen plus placebo', 'QBDT', 'Qinbudan decoction', 'traditional Chinese medicine Qinbudan tablet', 'isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin for 2 months (2HRZES), followed by isoniazid, rifampicin, ethambutol for 6 months (6HRE', 'placebo']","['cure rate', 'Adverse events and reactions', 'culture conversion', 'lesion absorption', 'culture conversion rate', 'efficacy and safety', 'sputum-culture conversion', 'lung lesion absorption and cavity closure', 'pruritus/nausea and vomiting', 'cavity closure']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum'}, {'cui': 'C0577916', 'cui_str': 'Lesion of lung'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",166.0,0.583189,"The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment.","[{'ForeName': 'Shao-Yan', 'Initials': 'SY', 'LastName': 'Zhang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Ji-You', 'Initials': 'JY', 'LastName': 'Fu', 'Affiliation': ""Shanghai University of Traditional Chinese Medicine, 1200 Cai Lun Road, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Guo', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Ding-Zhong', 'Initials': 'DZ', 'LastName': 'Wu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Chang-Rong', 'Initials': 'CR', 'LastName': 'Shao', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'He-Ping', 'Initials': 'HP', 'LastName': 'Xiao', 'Affiliation': ""Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Nai-Hui', 'Initials': 'NH', 'LastName': 'Chu', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing, 101149, People's Republic of China.""}, {'ForeName': 'Qun-Yi', 'Initials': 'QY', 'LastName': 'Deng', 'Affiliation': ""Department of Tuberculosis, Shenzhen Third People's Hospital, Shenzhen University School of Medicine, Shenzhen, 518000, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Tuberculosis, The Second Hospital of Nanjing, Nanjing, 210003, People's Republic of China.""}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Yan', 'Affiliation': ""Department of Tuberculosis, Chongqing Public Health Medical Center, Chongqing, 400036, People's Republic of China.""}, {'ForeName': 'Zhao-Long', 'Initials': 'ZL', 'LastName': 'Wang', 'Affiliation': ""Jinghua Pharmaceutical Group Co., Ltd, Nantong, 226005, People's Republic of China.""}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Biostatistics and Department of Epidemiology, School of Public Health, Fudan University, Shanghai, 200433, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Immunology and Microbiology, School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Yue-Juan', 'Initials': 'YJ', 'LastName': 'Zheng', 'Affiliation': ""Department of Immunology and Microbiology, School of Basic Medical Sciences, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.""}, {'ForeName': 'Pei-Yong', 'Initials': 'PY', 'LastName': 'Zheng', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Hui-Yong', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Zhen-Hui', 'Initials': 'ZH', 'LastName': 'Lu', 'Affiliation': ""Longhua Hospital Shanghai University of Traditional Chinese Medicine, 725 South Wanping Road, Shanghai, 200032, People's Republic of China. tcmdoctorlu@163.com.""}]",Infectious diseases of poverty,['10.1186/s40249-020-00660-z']
44,32385058,Cluster randomised controlled trial of home cook intervention to reduce salt intake in China: a protocol study.,"INTRODUCTION


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


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


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


ChiCTR1800016804.",2020,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","['For each province, 10 communities/villages (clusters) with 13 families (one cook and one adult family member', 'China', 'six provinces covering northern, central and southern China', 'In total, 780 home cooks and 780 adult family members will be recruited']","['intervention package, including community-based standardised offline and online health education and salt intake monitoring', 'home cook intervention']","['change in salt intake', 'change in salt-related knowledge, attitude and practice and blood pressure (BP']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.101015,"The secondary outcome is the difference between the two groups in the change in salt-related knowledge, attitude and practice and blood pressure (BP).
","[{'ForeName': 'Xiaochang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Beijing Center for Diseases Prevention and Control, Beijing, China.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China majx@chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Jinglei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Chinese Center for Disease Control and Prevention, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-033842']
45,32391862,A Multifaceted Antimicrobial Stewardship Program for the Treatment of Uncomplicated Cystitis in Nursing Home Residents.,"Importance


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


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


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


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


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


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


This study suggests that a low-intensity, multifaceted intervention was associated with improved antibiotic prescribing for uncomplicated cystitis in a cohort of nursing homes without an adverse association with other safety outcomes. Although promising, further study is needed to determine whether the intervention could be widely implemented to assist facilities in meeting new federal nursing home requirements for antimicrobial stewardship and quality assurance performance improvement programs.",2020,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","['25 nursing homes participating', 'noncatheterized nursing home residents', 'residents with unlikely cystitis in 25 nursing homes across the United States', 'Interventions\n\n\nIntervention nursing homes (n\u2009=\u200912', 'nursing home residents', 'Uncomplicated Cystitis in Nursing Home Residents']","['Multifaceted Antimicrobial Stewardship Program', '1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis', 'usual care']","['Overall antibiotic use', 'incidence of antibiotic treatment for unlikely cystitis cases', 'overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death', 'urinary tract infection', 'C difficile infection rates']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0698375,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hanlon', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Drinka', 'Affiliation': 'Division of Internal Medicine and Geriatrics, University of Wisconsin, Madison.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schweon', 'Affiliation': 'Infection Prevention Consultant, Saylorsburg, Pennsylvania.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1256']
46,32389434,"Emergency Department Stopping Elderly Accidents, Deaths and Injuries (ED STEADI) Program.","BACKGROUND


Falls are among the leading cause of emergency department (ED) visits.
OBJECTIVE


We set out to determine whether using a bedside decision aid could decrease falls.
METHODS


This randomized controlled trial was conducted on those aged ≥ 65 years who were being discharged home and screened positive for a Centers for Disease Control and Prevention (CDC) fall risk factor. Control-arm subjects were given a CDC brochure about falls. The active-arm subjects received a personalized decision aid intervention. Both groups were followed up via telephone.
RESULTS


A total of 200 subjects were enrolled and, after exclusions, 184 patients were analyzed. There were 76 male (41.3%) and 108 female (58.7%) subjects; 14% of the subjects chose to have their medications reviewed, 13.6% chose to have an eye examination, 22.8% chose to begin an exercise program, and the majority (44.6%) chose to have a home safety evaluation. Patients in the intervention arm chose more interventions to complete compared to control-arm subjects (p < 0.0001), but did not complete more interventions (p = 0.3387) and did not experience fewer falls compared to the control arm (p = 0.5675). At study conclusion, 73 subjects reported at least one fall during the study.
CONCLUSIONS


Overall, in this study, subjects who had their fall-risk interventions facilitated by a decision tool chose to participate in interventions more than control subjects. However, they did not complete the interventions or fall less often than their counterparts in the control arm. Future study is needed to determine the effect of CDC screening guidelines and interventions facilitated by a decision aid on fall outcomes and their application in the ED population.",2020,"Patients in the intervention arm chose more interventions to complete compared to control-arm subjects (p < 0.0001), but did not complete more interventions (p = 0.3387) and did not experience fewer falls compared to the control arm (p = 0.5675).","['those aged ≥', '73 subjects reported at least one fall during the study', '200 subjects were enrolled and, after exclusions, 184 patients were analyzed', '76 male (41.3%) and 108 female (58.7%) subjects; 14% of the subjects chose to have their medications reviewed, 13.6% chose to have an eye examination, 22.8% chose to begin an exercise program, and the majority (44.6%) chose to have a home safety evaluation', '65\xa0years who were being discharged home and screened positive for a Centers for Disease Control and Prevention (CDC) fall risk factor', 'subjects who had their fall-risk interventions facilitated by a decision tool chose to participate in interventions more than control subjects']","['personalized decision aid intervention', 'CDC brochure about falls']",[],"[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",[],200.0,0.0287967,"Patients in the intervention arm chose more interventions to complete compared to control-arm subjects (p < 0.0001), but did not complete more interventions (p = 0.3387) and did not experience fewer falls compared to the control arm (p = 0.5675).","[{'ForeName': 'Marna Rayl', 'Initials': 'MR', 'LastName': 'Greenberg', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Goodheart', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Jeanne L', 'Initials': 'JL', 'LastName': 'Jacoby', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Barraco', 'Affiliation': 'Department of Surgery, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Crowley', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Day', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Youngdahl', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Surmaitis', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Macfarlan', 'Affiliation': 'Network Office of Research and Innovation, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}, {'ForeName': 'Bryan G', 'Initials': 'BG', 'LastName': 'Kane', 'Affiliation': 'Department of Emergency and Hospital Medicine, Lehigh Valley Hospital and Health Network/University of South Florida Morsani College of Medicine, Allentown, Pennsylvania.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.019']
47,32394438,Efficacy of a fasting-mimicking diet in functional therapy for depression: A randomised controlled pilot trial.,"OBJECTIVE


This randomized controlled trial examined the efficacy of adding a fasting-mimicking diet to a structured psychotherapy protocol for treating depression.
DESIGN


Of 20 patients with depression, 10 were randomly assigned to psychotherapy and dieting (i.e., experimental group) and the other 10 to psychotherapy only (i.e., control group). Patients in both groups received 20 individual sessions of functional therapy along with nutrition consultation. Patients in the control group were instructed to maintain their usual daily diets.
RESULTS


Both treatments were effective in reducing depression as well as increasing self-esteem and quality of life. The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group.
CONCLUSIONS


The study revealed initial evidence of the efficacy of combining psychotherapy with a fasting-mimicking diet to treat depression and its correlates.",2020,"The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group.
","['depression', '20 patients with depression']","['fasting-mimicking diet', '20 individual sessions of functional therapy along with nutrition consultation', 'fasting-mimicking diet to a structured psychotherapy protocol']","['self-esteem and psychological quality of life', 'self-esteem and quality of life']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",20.0,0.0355997,"The experimental group showed improved self-esteem and psychological quality of life as well as a reduction in their mean body mass index, in comparison to the control group.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Maniaci', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'La Cascia', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Giammanco', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ferraro', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Chianetta', 'Affiliation': 'Department of Health Promotion, Mother, and Child Care, Internal Medicine and Medical Specialties, (PROMISE), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Di Peri', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Zaira', 'Initials': 'Z', 'LastName': 'Sardella', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Citarrella', 'Affiliation': 'Department of Health Promotion, Mother, and Child Care, Internal Medicine and Medical Specialties, (PROMISE), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Mannella', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Larcan', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Montana', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Mario G', 'Initials': 'MG', 'LastName': 'Mirisola', 'Affiliation': 'Department of Surgical, Oncological, and Oral Sciences, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Longo', 'Affiliation': 'Department of Biological Sciences, Longevity Institute, Davis School of Gerontology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Manfredi', 'Initials': 'M', 'LastName': 'Rizzo', 'Affiliation': 'Department of Health Promotion, Mother, and Child Care, Internal Medicine and Medical Specialties, (PROMISE), University of Palermo, Palermo, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'La Barbera', 'Affiliation': 'Section of Psychiatry, Department of Biomedicine, Neuroscience, and Advanced Diagnostic (BIND), University of Palermo, Palermo, Italy.'}]",Journal of clinical psychology,['10.1002/jclp.22971']
48,32334635,Preoperative assessment of lymph node metastasis in Colon Cancer patients using machine learning: a pilot study.,"BACKGROUND


Preoperative detection of lymph node (LN) metastasis is critical for planning treatments in colon cancer (CC). The clinical diagnostic criteria based on the size of the LNs are not sensitive to determine metastasis using CT images. In this retrospective study, we investigated the potential value of CT texture features to diagnose LN metastasis using preoperative CT data and patient characteristics by developing quantitative prediction models.
METHODS


A total of 390 CC patients, undergone surgical resection, were enrolled in this monocentric study. 390 histologically validated LNs were collected from patients and randomly separated into training (312 patients, 155 metastatic and 157 normal LNs) and test cohorts (78 patients, 39 metastatic and 39 normal LNs). Six patient characteristics and 146 quantitative CT imaging features were analyzed and key variables were determined using either exhaustive search or least absolute shrinkage algorithm. Two kernel-based support vector machine classifiers (patient-characteristic model and radiomic-derived model), generated with 10-fold cross-validation, were compared with the clinical model that utilizes long-axis diameter for diagnosis of metastatic LN. The performance of the models was evaluated on the test cohort by computing accuracy, sensitivity, specificity, and area under the receiver operating curve (AUC).
RESULTS


The clinical model had an overall diagnostic accuracy of 64.87%; specifically, accuracy of 65.38% and 62.82%, sensitivity of 83.87% and 84.62%, and specificity of 47.13% and 41.03% for training and test cohorts, respectively. The patient-demographic model obtained accuracy of 67.31% and 73.08%, the sensitivity of 62.58% and 69.23%, and specificity of 71.97% and 76.23% for training and test cohorts, respectively. Besides, the radiomic-derived model resulted in an accuracy of 81.09% and 79.49%, sensitivity of 83.87% and 74.36%, and specificity of 78.34% and 84.62% for training and test cohorts, respectively. Furthermore, the diagnostic performance of the radiomic-derived model was significantly higher than clinical and patient-demographic models (p < 0.02) according to the DeLong method.
CONCLUSIONS


The texture of the LNs provided characteristic information about the histological status of the LNs. The radiomic-derived model leveraging LN texture provides better preoperative diagnostic accuracy for the detection of metastatic LNs compared to the clinically accepted diagnostic criteria and patient-demographic model.",2020,The radiomic-derived model leveraging LN texture provides better preoperative diagnostic accuracy for the detection of metastatic LNs compared to the clinically accepted diagnostic criteria and patient-demographic model.,"['Colon Cancer patients using', '390 CC patients, undergone surgical resection', '390 histologically validated LNs were collected from patients and randomly separated into training (312 patients, 155 metastatic and 157 normal LNs) and test cohorts (78 patients, 39 metastatic and 39 normal LNs']","['Two kernel-based support vector machine classifiers', 'machine learning']","['accuracy, sensitivity, specificity, and area under the receiver operating curve (AUC', 'overall diagnostic accuracy']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2699740', 'cui_str': 'Support Vector Machine'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",390.0,0.025777,The radiomic-derived model leveraging LN texture provides better preoperative diagnostic accuracy for the detection of metastatic LNs compared to the clinically accepted diagnostic criteria and patient-demographic model.,"[{'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Eresen', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Shangguan', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Yury', 'Initials': 'Y', 'LastName': 'Velichko', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Yaghmai', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University, 675 N. St. Clair, 21st Floor, Chicago, IL, 60611, USA. albenson@nm.org.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Feinberg School of Medicine, Northwestern University, 737 N. Michigan Ave, Suite 1600, Chicago, IL, 60611, USA. zhuoli-zhang@northwestern.edu.'}]",Cancer imaging : the official publication of the International Cancer Imaging Society,['10.1186/s40644-020-00308-z']
49,32299024,"A double-blind, randomized controlled trial of duloxetine for pain in Parkinson's disease.","BACKGROUND


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


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


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


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


The study failed to provide evidence for the use of duloxetine for treating pain in people with Parkinson's disease.",2020,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[""people with Parkinson's disease in a single-arm, open-label study"", ""pain in Parkinson's disease"", ""people with Parkinson's disease"", ""46 patients with Parkinson's disease with pain to either the""]","['duloxetine', 'placebo', 'Duloxetine', 'duloxetine 40\xa0mg/day arm or the placebo']","['24-hour average pain severity measured by a visual analogue scale', ""Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39"", 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1576942', 'cui_str': 'duloxetine 40 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",46.0,0.692206,"Exploratory analyses indicated that treatment with duloxetine was associated with improved scores on the Unified Parkinson's Disease Rating Scale Part III and 3 domains of the Parkinson's Disease Questionnaire - 39.
","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Iwaki', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Laboratory of Neurogenetics, National Institute on Aging, National Institute of Health, MD, USA; Data Tecnica International, MD, USA.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Neurology, National Center Hospital of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Tsujii', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamanishi', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Miyaue', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Yabe', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Matsuyama Hospital, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nagai', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nomoto', 'Affiliation': 'Department of Neurology and Clinical Pharmacology, Ehime University, Ehime, Japan; Department of Neurology, Saiseikai Imabari Hospital, Ehime, Japan. Electronic address: nomoto1492@nifty.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116833']
50,32364805,Global REACH 2018: The Effect of an Expiratory Resistance Mask with Dead Space on Sleep and Acute Mountain Sickness During Acute Exposure to Hypobaric Hypoxia.,"Carr, Jay, Rachel Stone, Courtney Tymko, Kaitlyn Tymko, Geoff B. Coombs, Ryan L. Hoiland, Connor A. Howe, Michael M. Tymko, Philip N. Ainslie, and Alexander Patrician. Global REACH 2018: the effect of an expiratory resistance mask with dead space on sleep and acute mountain sickness during acute exposure to hypobaric hypoxia.  High Alt Med Biol . 21:297-302, 2020. We hypothesized that an expiratory resistance and dead space (ER/DS) mask, a version of which was previously shown to partially alleviate sleep-disordered breathing and headache severity during acute normobaric hypoxia (Patrician et al.), would exhibit similar results in conditions of hypobaric hypoxia. In a randomized, single-blinded, sham-controlled, and sex-matched design, 31 healthy lowlanders rapidly (6-8 hours) ascended from sea level to 4300 m (Cerro de Pasco, Peru) and slept with either an ER/DS mask ( n  = 15) or sham mask ( n  = 16). Sleep was assessed (via WatchPAT) and questionnaires collected before sleep and upon waking the morning after. There was no difference in apnea-hypopnea index (AHI) between the ER/DS (77 ± 20 events/h) or sham mask (84 ± 27 events/h;  p  = 0.57). In addition, there was no alleviation of headache scores, improvement in sleep quality, or acute mountain sickness symptom severity. Both the sham and ER/DS masks were poorly tolerated (∼50% subject noncompliance in both groups). These findings highlight the importance and necessity of field-testing and demonstrate that more testing is needed before ER/DS devices, such as these, can be recommended for prophylactic benefits at high altitude.",2020,"In addition, there was no alleviation of headache scores, improvement in sleep quality, or acute mountain sickness symptom severity.",['31 healthy lowlanders rapidly (6-8 hours) ascended from'],"['Expiratory Resistance Mask with Dead Space', 'sea level to 4300\u2009m (Cerro de Pasco, Peru) and slept with either an ER/DS mask ( n \u2009=\u200915) or sham mask']","['Sleep and Acute Mountain Sickness', 'headache scores, improvement in sleep quality, or acute mountain sickness symptom severity', 'Sleep', 'apnea-hypopnea index (AHI']","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031238', 'cui_str': 'Peru'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0344712,"In addition, there was no alleviation of headache scores, improvement in sleep quality, or acute mountain sickness symptom severity.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Carr', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Stone', 'Affiliation': 'Department of Kinesiology, University of Windsor, Windsor, Canada.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Tymko', 'Affiliation': 'Department of Kinesiology, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Geoff B', 'Initials': 'GB', 'LastName': 'Coombs', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Hoiland', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Connor A', 'Initials': 'CA', 'LastName': 'Howe', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Patrician', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, School of Health and Exercise Sciences, Faculty of Health and Social Development, University of British Columbia-Okanagan Campus, Kelowna, Canada.'}]",High altitude medicine & biology,['10.1089/ham.2019.0124']
51,32364838,Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study.,"PURPOSE


We compared the hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex™ Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup.
MATERIALS AND METHODS


This is a multicenter, single-blind, prospective, randomized trial of 141 patients treated with flexible ureteroscopy for renal stones. Primary outcome was Ureteral Stent Symptom Questionnaire (USSQ) Body Pain Index recorded before Double-J® stent removal at day (D) 20. Secondary endpoints were USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation.
RESULTS


The trial was completed by 113 (80.1%) patients. Mean (SD) USSQ body pain scores were 25% lower at D20 for the silicone stent at 18.7 (11.4) vs 25.1 (14.2) (p=0.015). No difference in terms of adverse events and safety profile was observed. USSQ urinary symptoms scores at D2, D7 and D20 were lower in the silicone stent group at 26.4 (7.7) vs 31.8 (8.1) at D20 (p <0.001). The use of USSQ self-questionnaires was associated with a limited number of missing or incomplete answers.
CONCLUSIONS


The primary results of this large sample prospective randomized controlled study comparing the silicone Imajin hydro stents to the Percuflex Plus stent show that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.",2020,Imajin® hydro result in lower pain and discomfort following flexible ureteroscopy as compared to Percuflex TM  ,"['patients who require stenting for stone disease', '141 patients treated with fURS for renal stones', 'Patients Undergoing Flexible Ureteroscopy for Kidney Stone']","['silicone DJ stents', 'flexible ureteroscopy (fURS', 'hydrocoated silicone stent (Coloplast Imajin® hydro) to Percuflex TM  Plus stent (Boston Scientific', 'flexible ureteroscopy', 'Materials and Methdos', 'Silicone Hydrocoated Double Loop Ureteral Stent', 'silicone Imajin® hydro stents', 'Percuflex TM']","['USSQ Body Pain Index recorded before DJ removal at day 20 (D20', 'Symptoms and Quality of Life', 'USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation', 'patient discomfort', 'Mean (SD) USSQ body pain scores', 'USSQ urinary symptoms scores at D2, D7 and D20', 'pain and discomfort', 'adverse events and safety profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0070387', 'cui_str': 'percuflex TM'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",141.0,0.171524,Imajin® hydro result in lower pain and discomfort following flexible ureteroscopy as compared to Percuflex TM  ,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Wiseman', 'Affiliation': ""Urology Department, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Ventimiglia', 'Affiliation': 'Division of Experimental Oncology/Unit of Urology; URI; IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Steeve', 'Initials': 'S', 'LastName': 'Doizi', 'Affiliation': ""Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Kleinclauss', 'Affiliation': 'Department of Urology and Renal Transplantation, CHRU Besancon, Besancon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Letendre', 'Affiliation': 'Maisonneuve-Rosemont Hospital, Urology, Montreal, Quebec, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cloutier', 'Affiliation': 'University Hospital Centre of Quebec City, Urology, Quebec, Quebec, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': ""Sorbonne Université, Service d'Urologie, AP-HP, Hôpital Tenon, Paris, France.""}]",The Journal of urology,['10.1097/JU.0000000000001098']
52,32364568,Comparison Between Rituximab Treatment for New-Onset Generalized Myasthenia Gravis and Refractory Generalized Myasthenia Gravis.,"Importance


Use of biologic agents in generalized myasthenia gravis is generally limited to therapy-refractory cases; benefit in new-onset disease is unknown.
Objective


To assess rituximab in refractory and new-onset generalized myasthenia gravis and rituximab vs conventional immunotherapy in new-onset disease.
Design, Setting, and Participants


A retrospective cohort study with prospectively collected data was conducted on a county-based community sample at Karolinska University Hospital, Stockholm, Sweden. Participants included 72 patients with myasthenia gravis, excluding those displaying muscle-specific tyrosine kinase antibodies, initiating rituximab treatment from January 1, 2010, to December 31, 2018, and patients with new-onset disease initiating conventional immunotherapy from January 1, 2003, to December 31, 2012, with 12 months or more of observation time. The present study was conducted from March 1, 2019, to January 31, 2020.
Exposures


Treatment with low-dose rituximab (most often 500 mg every 6 months) or conventional immunosuppressants.
Main Outcomes and Measures


Time to remission (main outcome) as well as use of rescue therapies or additional immunotherapies and time in remission (secondary outcomes).
Results


Of the 72 patients included, 31 patients (43%) were women; mean (SD) age at treatment start was 60 (18) years. Twenty-four patients had received rituximab within 12 months of disease onset and 48 received rituximab at a later time, 34 of whom had therapy-refractory disease. A total of 26 patients (3 [12%] women; mean [SD] age, 68 [11] years at treatment start) received conventional immunosuppressant therapy. Median time to remission was shorter for new-onset vs refractory disease (7 vs 16 months: hazard ratio [HR], 2.53; 95% CI, 1.26-5.07; P = .009 after adjustment for age, sex, and disease severity) and for rituximab vs conventional immunosuppressant therapies (7 vs 11 months: HR, 2.97; 95% CI, 1.43-6.18; P = .004 after adjustment). In addition, fewer rescue therapy episodes during the first 24 months were required (mean [SD], 0.38 [1.10] vs 1.31 [1.59] times; mean difference, -1.26; 95% CI, -1.97 to -0.56; P < .001 after adjustment), and a larger proportion of patients had minimal or no need of additional immunotherapies (70% vs 35%; OR, 5.47; 95% CI, 1.40-21.43; P = .02 after adjustment). Rates of treatment discontinuation due to adverse events were lower with rituximab compared with conventional therapies (3% vs 46%; P < .001 after adjustment).
Conclusions and Relevance


Clinical outcomes with rituximab appeared to be more favorable in new-onset generalized myasthenia gravis, and rituximab also appeared to perform better than conventional immunosuppressant therapy. These findings suggest a relatively greater benefit of rituximab earlier in the disease course. A placebo-controlled randomized trial to corroborate these findings is warranted.",2020,"Median time to remission was shorter for new-onset vs refractory disease (7 vs 16 months: hazard ratio [HR], 2.53; 95% CI, 1.26-5.07; P = .009 after adjustment for age, sex, and disease severity) and for rituximab vs conventional immunosuppressant therapies (7 vs 11 months: HR, 2.97; 95% CI, 1.43-6.18; P = .004 after adjustment).","['Participants included 72 patients with myasthenia gravis, excluding those displaying muscle-specific tyrosine kinase antibodies, initiating rituximab treatment from January 1, 2010, to December 31, 2018, and patients with new-onset disease initiating conventional immunotherapy from January 1, 2003, to December 31, 2012, with 12 months or more of observation time', '72 patients included, 31 patients (43%) were women', 'March 1, 2019, to January 31, 2020', 'New-Onset Generalized Myasthenia Gravis and Refractory Generalized Myasthenia Gravis', 'generalized myasthenia gravis', 'Participants\n\n\nA retrospective cohort study with prospectively collected data was conducted on a county-based community sample at Karolinska University Hospital, Stockholm, Sweden', '26 patients (3 [12%] women; mean [SD] age, 68']","['rituximab vs conventional immunotherapy', 'biologic agents', 'low-dose rituximab', 'conventional immunosuppressant therapy', 'Rituximab Treatment', 'rituximab', 'placebo']","['Rates of treatment discontinuation due to adverse events', 'Measures\n\n\nTime to remission (main outcome) as well as use of rescue therapies or additional immunotherapies and time in remission (secondary outcomes', 'Median time to remission', 'rescue therapy episodes']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0033681', 'cui_str': 'Protein-tyrosine kinase'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",72.0,0.218016,"Median time to remission was shorter for new-onset vs refractory disease (7 vs 16 months: hazard ratio [HR], 2.53; 95% CI, 1.26-5.07; P = .009 after adjustment for age, sex, and disease severity) and for rituximab vs conventional immunosuppressant therapies (7 vs 11 months: HR, 2.97; 95% CI, 1.43-6.18; P = .004 after adjustment).","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Brauner', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Eriksson-Dufva', 'Affiliation': 'Department of Neurology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Max Albert', 'Initials': 'MA', 'LastName': 'Hietala', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Frisell', 'Affiliation': 'Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rayomand', 'Initials': 'R', 'LastName': 'Press', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Piehl', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA neurology,['10.1001/jamaneurol.2020.0851']
53,32360666,Progesterone vaginal ring as a new contraceptive option for lactating mothers: Evidence from a multicenter non-randomized comparative clinical trial in India.,"OBJECTIVES


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


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


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


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


PVR, a user-controlled device, offers an additional contraceptive choice for lactating women for one-year postpartum use and can help to address the unmet need for contraception among postpartum women while encouraging breastfeeding to enhance infant growth and well-being.",2020,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","['lactating women', 'lactating mothers', '789 women (459 PVR, 330 IUD', 'married lactating women (20-35 years) using the', ""participants' infants""]","['progesterone vaginal ring (PVR) or Copper-T380A intrauterine device (IUD', 'Progesterone vaginal ring']","['PI nor K-M one-year pregnancy rates', 'median duration of LA', 'Continuation rates', 'Pearl Index (PI) and Kaplan Meier (K-M) rates', 'Efficacy and safety outcomes', 'adverse events', 'contraceptive efficacy, safety, continuation rates and duration of lactational amenorrhea (LA']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0473315', 'cui_str': 'Lactational amenorrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}]",789.0,0.262346,"Continuation rates for PVR, a woman-controlled method, were shorter than IUD rates while PVR users maintained LA significantly longer than IUD users.","[{'ForeName': 'Malabika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India. Electronic address: malaroy69@gmail.com.'}, {'ForeName': 'Avishek', 'Initials': 'A', 'LastName': 'Hazra', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Merkatz', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Plagianos', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Mohcine', 'Initials': 'M', 'LastName': 'Alami', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Gaur', 'Affiliation': 'Indian Council of Medical Research, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Kumudha', 'Initials': 'K', 'LastName': 'Aruldas', 'Affiliation': 'Population Council, Zone 5A, India Habitat Centre, New Delhi, India.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Sussman', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Government Medical College, SMGS Hospital, Jammu, India; Postgraduate Institute of Medical Education and Research Chandigarh, India; Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, India; All India Institute of Medical Sciences, New Delhi, India; K.G. Medical University, Lucknow, India; Motilal Nehru Medical College and Hospital, Prayagraj, India; GSVM Medical College and Hospital, Kanpur, India; SMS Medical College and Zanana Hospital, Jaipur, India; Institute of Obstetrics and Gynecology, Madras Medical College, Chennai, India; Government Medical College and SAT Hospital, Thiruvananthapuram, India; Jawaharlal Nehru Medical College and Hospital, Belagavi, India; Patna Medical College and Hospital, Patna, India; R.G. Kar Medical College and Hospital, Kolkata, India; Medical College and Eden Hospital, Kolkata, India; SCB Medical College and Hospital, Cuttack, India; Seth GS Medical College and KEM Hospital, Mumbai, India; KEM Hospital, Pune, India; Grant Medical College and Sir JJ Group of Hospitals, Mumbai, India; Goa Medical College and Hospital, Goa, India; Indian Council of Medical Research - National Institute for Research in Reproductive Health, Mumbai, India.'}]",Contraception,['10.1016/j.contraception.2020.04.016']
54,32374710,Effects of a Communication Intervention Randomized Controlled Trial to Enable Goals-of-Care Discussions.,"PURPOSE


Patients with advanced cancer often have a poor understanding of cancer incurability, which correlates with more aggressive treatment near the end of life (EOL). We sought to determine whether training oncologists to elicit patient values for goals-of-care (GoC) discussions will increase and improve these discussions. We explored its impact on use of aggressive care at EOL.
METHODS


We enrolled and used block randomization to assign 92% of solid tumor oncologists to 2-hour communication skills training and four coaching sessions. We surveyed 265 patient with newly diagnosed advanced cancer with < 2-year life expectancy at baseline and 6 months. We assessed prevalence and quality of GoC communication, change in communication skills, and use of aggressive care in the last month of life.
RESULTS


Intervention (INT) oncologists' (n = 11) skill to elicit patient values increased (27%-55%), while usual care (UC) oncologists' (n = 11) skill did not (9%-0%;  P  = .01). Forty-eight percent (n = 74) INT  v  51% (n = 56) UC patients reported a GoC discussion ( P  = .61). There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23). Within 6 months, there was no difference in deaths (18 INT  v  16 UC;  P  = .51), mean hospitalizations (0.47 INT  v  0.42 UC;  P  = .63), intensive care unit admissions (5% INT  v  9% UC;  P  = .65), or chemotherapy (26% INT  v  16% UC;  P  = .39).
CONCLUSION


Use of a coaching model focused on teaching oncologists to elicit patient values improved that skill but did not increase prevalence or quality of GoC discussions among patients with advanced cancer. There was no impact on high care utilization at EOL.",2020,"There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23).","['Forty-eight percent (n = 74', 'Patients with advanced cancer', '265 patient with newly diagnosed advanced cancer with < 2-year life expectancy at baseline and 6 months', 'patients with advanced cancer']",[],"['prevalence or quality of GoC discussions', 'prevalence and quality of GoC communication, change in communication skills, and use of aggressive care', 'mean hospitalizations', 'prevalence or quality of GoC communication', 'deaths', 'intensive care unit admissions']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.0728591,"There was no difference in the prevalence or quality of GoC communication between groups (global odds ratio, 0.84; 95% CI, 0.57 to 1.23).","[{'ForeName': 'Nina A', 'Initials': 'NA', 'LastName': 'Bickell', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Back', 'Affiliation': 'Center of Excellence in Palliative Care, University of Washington, Seattle, WA.'}, {'ForeName': 'Kerin', 'Initials': 'K', 'LastName': 'Adelson', 'Affiliation': 'Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Gonsky', 'Affiliation': 'Kings County Hospital Center, Brooklyn, NY.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Egorova', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Sofya', 'Initials': 'S', 'LastName': 'Pintova', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jenny J', 'Initials': 'JJ', 'LastName': 'Lin', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kozuch', 'Affiliation': 'Mount Sinai Beth Israel Comprehensive Cancer Center West, New York, NY.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Bagiella', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Cardinale B', 'Initials': 'CB', 'LastName': 'Smith', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",JCO oncology practice,['10.1200/OP.20.00040']
55,32382082,High-risk additional chromosomal abnormalities at low blast counts herald death by CML.,"Blast crisis is one of the remaining challenges in chronic myeloid leukemia (CML). Whether additional chromosomal abnormalities (ACAs) enable an earlier recognition of imminent blastic proliferation and a timelier change of treatment is unknown. One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV were analyzed for ACA/Ph+ and blast increase. By impact on survival, ACAs were grouped into high risk (+8, +Ph, i(17q), +17, +19, +21, 3q26.2, 11q23, -7/7q abnormalities; complex) and low risk (all other). The presence of high- and low-risk ACAs was linked to six cohorts with different blast levels (1%, 5%, 10%, 15%, 20%, and 30%) in a Cox model. One hundred and twenty-three patients displayed ACA/Ph+ (8.1%), 91 were high risk. At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA. No effect was observed at blast levels of 20-30%. Sixty-three patients with high-risk ACA (69%) died (n = 37) or were alive after progression or progression-related transplantation (n = 26). High-risk ACA at low blast counts identify end-phase CML earlier than current diagnostic systems. Mortality was lower with earlier treatment. Cytogenetic monitoring is indicated when signs of progression surface or response to therapy is unsatisfactory.",2020,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","['chronic myeloid leukemia (CML', 'Sixty-three patients with high-risk ACA (69%) died (n\u2009=\u200937) or were alive after progression or progression-related transplantation (n\u2009=\u200926', 'One thousand five hundred and ten imatinib-treated patients with Philadelphia-chromosome-positive (Ph+) CML randomized in CML-study IV']",[],"['Mortality', 'survival, ACAs']","[{'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0149561', 'cui_str': 'Structure of anterior cerebral artery'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0450407', 'cui_str': 'ph+'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008625', 'cui_str': 'Abnormalities, Chromosome'}]",63.0,0.0438058,"At low blast levels (1-15%), high-risk ACA showed an increased hazard to die compared to no ACA (ratios: 3.65 in blood; 6.12 in marrow) in contrast to low-risk ACA.","[{'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Hehlmann', 'Affiliation': 'ELN Foundation, Weinheim, Germany. hehlmann.eln@gmail.com.'}, {'ForeName': 'Astghik', 'Initials': 'A', 'LastName': 'Voskanyan', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lauseker', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Pfirrmann', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Kalmanti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Rinaldetti', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kohlbrenner', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Haferlach', 'Affiliation': 'MLL, München, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schlegelberger', 'Affiliation': 'Institut für Humangenetik, MHH, Hannover, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fabarius', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Seifarth', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Spieß', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wuchter', 'Affiliation': 'Institut für Transfusionsmedizin und Immunologie, Medizinische Fakultät Mannheim, Universität Heidelberg und DRK-Blutspendedienst, Mannheim, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany.'}, {'ForeName': 'Hans-Jochem', 'Initials': 'HJ', 'LastName': 'Kolb', 'Affiliation': 'Medizinische Klinik III, Universitätsklinikum Großhadern, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Dieter K', 'Initials': 'DK', 'LastName': 'Hossfeld', 'Affiliation': '2. Medizinische Klinik, Universitätsklinikum Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nerl', 'Affiliation': 'Klinikum Schwabing, München, Germany.'}, {'ForeName': 'Alois', 'Initials': 'A', 'LastName': 'Gratwohl', 'Affiliation': 'Universitätsspital, Basel, Switzerland.'}, {'ForeName': 'Gabriela M', 'Initials': 'GM', 'LastName': 'Baerlocher', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Klinik für Innere Medizin, Universitätsklinikum, Marburg, Germany.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Brümmendorf', 'Affiliation': 'Uniklinik RWTH, Aachen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'IBE Universität München, München, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum, Jena, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Saußele', 'Affiliation': 'III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baccarani', 'Affiliation': 'Department of Hematology-Oncology, Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0826-9']
56,32397926,"2B, 2C, or 3: What Should Be the Angiographic Target for Endovascular Treatment in Ischemic Stroke?","Background and Purpose- A score of ≥2B on the modified Thrombolysis in Cerebral Infarction scale is generally regarded as successful reperfusion after endovascular treatment for ischemic stroke. The extended Thrombolysis in Cerebral Infarction (eTICI) includes a 2C grade, which indicates near-perfect reperfusion. We investigated how well the respective eTICI scores of 2B, 2C, and 3 correlate with clinical outcome after endovascular treatment. Methods- We used data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands. We included patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available. Our primary outcome was the distribution on the modified Rankin Scale at 90 days per eTICI grade. We performed (ordinal) logistic regression analyses, using eTICI 2B as reference group, and adjusted for potential confounders. Results- In total, 2807/3637 (77%) patients met the inclusion criteria. Of these, 17% achieved reperfusion grade eTICI 0 to 1, 14% eTICI 2A, 25% eTICI 2B, 12% eTICI 2C, and 32% eTICI 3. Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01). Procedure times decreased with increasing reperfusion grades. We found a positive association between reperfusion grade and functional outcome, which continued to increase after eTICI 2B (adjusted common odds ratio, 1.22 [95% CI, 0.96-1.57] for eTICI 2C versus 2B; adjusted common odds ratio, 1.33 [95% CI, 1.09-1.62] for eTICI 3 versus 2B). Conclusions- Our results indicate a continuous relationship between reperfusion grade and functional outcome, with eTICI 3 leading to the best outcomes. Although this implies that interventionists should aim for the highest possible reperfusion grade, further research on the optimal strategy is necessary.",2020,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"['patients with a proximal intracranial occlusion of the anterior circulation for whom final antero-posterior and lateral digital subtraction angiography imaging was available', 'Acute Ischemic Stroke in the Netherlands Registry, a prospective, nationwide registry of endovascular treatment in the Netherlands']","['Methods', 'Endovascular Treatment', ' and Purpose', 'Conclusions']","['reperfusion grade eTICI', 'Cerebral Infarction scale', 'occlusion location', 'distribution on the modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",,0.078079,Groups differed in terms of age ( P <0.001) and occlusion location ( P <0.01).,"[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'LeCouffe', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Manon', 'Initials': 'M', 'LastName': 'Kappelhof', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'Department of Public Health, Center for Medical Decision Making, Erasmus MC University Medical Center Rotterdam, the Netherlands (H.F.L.).'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Harbin Medical University, China (G.Z.).'}, {'ForeName': 'Ido R', 'Initials': 'IR', 'LastName': 'van den Wijngaard', 'Affiliation': 'Department of Neurology, Haaglanden Medical Center, the Hague, the Netherlands (I.R.v.d.W.).'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Erasmus MC University Medical Center Rotterdam, the Netherlands (A.C.G.M.v.E.).'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.K., K.M.T., B.J.E., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'From the Department of Neurology (N.E.L., Y.B.W.E.M.R., J.M.C.), Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028891']
57,32396917,"Improving Cost-effectiveness and Access to Cognitive Behavior Therapy for Depression: Providing Remote-Ready, Computer-Assisted Psychotherapy in Times of Crisis and Beyond.","INTRODUCTION


There is growing evidence that computer-delivered or computer-assisted forms of cognitive behavior therapy (CCBT) are helpful, but cost-effectiveness versus standard therapies is not well established.
OBJECTIVE


To evaluate the cost-effectiveness of a therapist-supported method for CCBT in comparison to standard cognitive behavior therapy (CBT).
METHODS


A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact). Outcomes were assessed at baseline, weeks 8 and 16, and at 3 and 6 months post-treatment. Economic analyses took into account the costs of services received and work/social role impairment.
RESULTS


In the context of almost identical efficacy, a form of CCBT that used only about one third the amount of therapist contact as conventional CBT was highly cost-effective compared to conventional therapy and reduced the adjusted cost of treatment by USD 945 per patient.
CONCLUSIONS


A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery.",2020,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"['154 drug-free major depressive disorder outpatients', 'Depression']","['cognitive behavior therapy (CCBT', 'Cognitive Behavior Therapy', 'therapist-supported method for CCBT', 'CCBT', 'standard cognitive behavior therapy (CBT', 'standard CBT']",['cost-effectiveness'],"[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0290312,A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact).,"[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA, thase@pennmedicine.upenn.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""King's College, London, United Kingdom.""}, {'ForeName': 'Marna S', 'Initials': 'MS', 'LastName': 'Barrett', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Tracy D', 'Initials': 'TD', 'LastName': 'Eells', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jesse H', 'Initials': 'JH', 'LastName': 'Wright', 'Affiliation': 'Unversity of Louisville, Louisville, Kentucky, USA.'}]",Psychotherapy and psychosomatics,['10.1159/000508143']
58,31738014,"Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.","OBJECTIVE


Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM.
METHODS


Participants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks.
RESULTS


After 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS.
CONCLUSION


Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.",2020,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","['women with FM', 'Women with Fibromyalgia', 'Participants']","['Transcutaneous electrical nerve stimulation (TENS', 'active-TENS', 'placebo-TENS or no-TENS', 'placebo-TENS (n=99) or no-TENS', 'TENS']","['movement-evoked pain and fatigue', 'movement-evoked pain', 'global impression of change', 'movement-evoked pain (primary outcome) and fatigue on an 11-point scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0222045'}]",,0.528626,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","[{'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'University of Iowa, Iowa City, and St. Ambrose University, Davenport, Iowa.'}, {'ForeName': 'Carol G T', 'Initials': 'CGT', 'LastName': 'Vance', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'New York University, New York, New York.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Golchha', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'University of Iowa, Iowa City.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41170']
59,32368935,A Randomized Controlled Trial of Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis: 19-Year Clinical and Radiological Follow-up.,"BACKGROUND


Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB) is a reliable surgical option for the control of anterior knee laxity after ACL injury. The addition of a lateral extra-articular tenodesis (LET) may improve control of rotation knee laxity and improve short-term graft survival in high-risk patients.
PURPOSE


The aims of this study were to compare long-term patient-reported outcomes, graft survival, and risk of osteoarthritis between ACLR with and without LET.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


This study included 121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999. In total, 61 knees were randomized to an isolated BTB ACLR, and 60 knees were randomized to a BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire).
RESULTS


Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2). Of those patients, 43 had a clinical examination and completed patient-reported outcome questionnaires, and the other 37 patients were evaluated through the questionnaires alone. Standard radiographs were available for 45 patients and laximetry (TELOS) for 42 patients. Mean subjective International Knee Documentation Committee score at last follow-up was 81.8, and no differences were noted between the BTB and BTB-LET groups ( P  = .7). Two-thirds of patients were still participating in pivoting sports. A total of 17 knees (21%) experienced a graft failure, 5 of which (6%) underwent revision ACLR. There was no significant difference in graft failure risk between the BTB group (29%) and the BTB-LET group (13%;  P  = .1). Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%;  P  = .02). Lateral compartment osteoarthritis was correlated with partial lateral meniscectomy.
CONCLUSION


There were no significant differences in long-term patient-reported outcomes after ACLR with or without an LET. LET may increase the risk of lateral compartment osteoarthritis at long-term follow-up. There was a trend toward decreased graft failure risk with the addition of LET but this study was underpowered to assess this outcome.",2020,Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%;  P  = .02).,"['61 knees were randomized to an isolated BTB ACLR, and 60 knees', 'high-risk patients', '45 patients and laximetry (TELOS) for 42 patients', '121 consecutive knees (120 patients) presenting to a single center with an ACL rupture between 1998 and 1999', 'Eighty knees in 79 patients (66%) were available for follow-up at a postoperative mean of 19.4 years (range, 19-20.2']","['Bone-Patellar Tendon-Bone Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis', 'LET', 'BTB ACLR with an extra-articular lateral tenodesis with gracilis tendon (modified Lemaire', 'Arthroscopic anterior cruciate ligament (ACL) reconstruction (ACLR) with a bone-patellar tendon-bone graft (BTB', 'lateral extra-articular tenodesis (LET']","['graft failure risk', 'Mean subjective International Knee Documentation Committee score', 'Lateral compartment osteoarthritis', 'graft survival, and risk of osteoarthritis', 'risk of lateral compartment osteoarthritis', 'Lateral tibiofemoral osteoarthritis', 'rotation knee laxity and improve short-term graft survival', 'graft failure']","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517642', 'cui_str': '20.2'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0185441', 'cui_str': 'Fixation of tendon'}, {'cui': 'C3658331', 'cui_str': 'Bone-Patellar Tendon-Bone Grafts'}, {'cui': 'C0448621', 'cui_str': 'Tendon of gracilis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",61.0,0.143888,Lateral tibiofemoral osteoarthritis was significantly more frequent in the BTB-LET group (59%) as compared with the BTB group (22%;  P  = .02).,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Castoldi', 'Affiliation': 'Institut Universitaire Locomoteur et du Sport, Department of Orthopaedic Surgery, Centre Hospitalo-Universitaire de Nice, Nice, France.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Magnussen', 'Affiliation': 'Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Gunst', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Batailler', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Neyret', 'Affiliation': 'Infirmerie Protestante, Caluire, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Lustig', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Servien', 'Affiliation': 'Department of Orthopedic Surgery and Sport Medicine, Croix-Rousse Hospital, FIFA Medical Center of Excellence, Lyon, France.'}]",The American journal of sports medicine,['10.1177/0363546520914936']
60,32374188,Effects of a highly controlled carbohydrate-reduced high-protein diet on markers of oxidatively generated nucleic acid modifications and inflammation in weight stable participants with type 2 diabetes; a randomized controlled trial.,"Carbohydrate-restricted diets are increasingly recognized as options for dietary management of type 2 diabetes mellitus (T2DM). We investigated the effects of a carbohydrate-reduced high-protein (CRHP) and a conventional diabetes (CD) diet on oxidative stress and inflammation in weight stable individuals with T2DM. We hypothesized that the CRHP diet would improve markers of oxidatively generated RNA and DNA modifications as well as inflammatory parameters. Thirty participants with T2DM were randomized to 6 weeks of CRHP or CD dietary treatment (30/50 energy percentage (E%) carbohydrate, 30/17E% protein, 40/33E% fat), followed by a cross-over to the opposite diet for a subsequent 6-week period. All meals were provided during the study and body weight was controlled. Diurnal urine samples were collected after 4 weeks on each diet and oxidatively generated RNA and DNA modifications were measured as 8-oxo-7,8-dihydroguanosine (8-oxoGuo) and 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG), respectively. Fasting concentrations of soluble urokinase plasminogen activator receptor, high-sensitivity C-reactive protein, tumor necrosis factor alpha and interleukin-6 were measured before and after 6 weeks of interventions. Compared with the CD diet, the CRHP diet increased 24-hour urinary excretion of 8-oxoGuo by 9.3% (38.6 ± 12.6 vs. 35.3 ± 11.0 nmol/24 h,  p =  .03), whereas 8-oxodG did not differ between diets (24.0 ± 9.5 vs. 24.8 ± 11.1 nmol/24 h,  p  = .17). Changes in plasma inflammatory parameters did not differ between CRHP and CD diets, all  p ≥  .2. The clinical implications of increased RNA oxidation following a CRHP diet as well as long-term effects of carbohydrate-restriction on markers of oxidatively generated nucleic acid modifications should be a field of future study.",2020,"Changes in plasma inflammatory parameters did not differ between CRHP and CD diets, all  p ≥  .2.","['Thirty participants with T2DM', 'weight stable participants with type 2 diabetes', 'weight stable individuals with T2DM']","['carbohydrate-reduced high-protein (CRHP', 'CRHP diet', 'Carbohydrate-restricted diets', 'conventional diabetes (CD) diet', 'CRHP or CD dietary treatment (30/50 energy percentage (E%) carbohydrate, 30/17E% protein, 40/33E% fat), followed by a cross-over to the opposite diet', 'highly controlled carbohydrate-reduced high-protein diet']","['Diurnal urine samples', 'Fasting concentrations of soluble urokinase plasminogen activator receptor, high-sensitivity C-reactive protein, tumor necrosis factor alpha and interleukin-6', 'plasma inflammatory parameters', '24-hour urinary excretion of 8-oxoGuo', '8-oxodG']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0424657', 'cui_str': 'Weight steady'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0071216', 'cui_str': 'Lymphocyte antigen CD87'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0050092', 'cui_str': '8-hydroxyguanosine'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}]",30.0,0.0199666,"Changes in plasma inflammatory parameters did not differ between CRHP and CD diets, all  p ≥  .2.","[{'ForeName': 'Mads Juul', 'Initials': 'MJ', 'LastName': 'Skytte', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Amirsalar', 'Initials': 'A', 'LastName': 'Samkani', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Meinert', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Frystyk', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Henrik Enghusen', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Henriksen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, and Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre and the Emergency Department, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Madsbad', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Steen Bendix', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Thure', 'Initials': 'T', 'LastName': 'Krarup', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Emil List', 'Initials': 'EL', 'LastName': 'Larsen', 'Affiliation': 'Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1759137']
61,32376724,"Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210) for advanced osteosarcoma (APFAO) progressing after chemotherapy: a single-arm, open-label, phase 2 trial.","BACKGROUND


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


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


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


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


NCT03359018.",2020,"Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients.","['Patients with programmed cell death 1 ligand-1 (PD-L1', ""Peking University People's Hospital"", '43 patients were enrolled between January 25 and September 4, 2018', 'enrolled patients with advanced osteosarcoma progressed after chemotherapy', 'patients with inoperable high-grade osteosarcoma progressing after chemotherapy', 'advanced osteosarcoma (APFAO) progressing after chemotherapy']","['Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210', '500\u2009mg apatinib orally once daily plus 200\u2009mg camrelizumab', 'camrelizumab']","['Toxic effects', 'progression free', '6-month PFS rate', 'Overexpression of PD-L1 and the presence of pulmonary metastases', 'objective response rate', 'progression-free survival (PFS) and clinical benefit rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029463', 'cui_str': 'Osteosarcoma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2346836', 'cui_str': 'apatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4552121', 'cui_str': 'SHR-1210'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",43.0,0.208514,"Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China bonetumor@163.com.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Surgical Oncology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Kuisheng', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Bingxin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Ren', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Taiqiang', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Musculoskeletal Tumor Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Kunkun', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': ""Pathology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Danhua', 'Initials': 'D', 'LastName': 'Shen', 'Affiliation': ""Pathology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Radiology Department & Nuclear Medicine Department, Peking University People's Hospital, Beijing, China.""}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000798']
62,32381420,"Treatment Rationale and Design for APPLE (WJOG11218L): A Multicenter, Open-Label, Randomized Phase 3 Study of Atezolizumab and Platinum/Pemetrexed With or Without Bevacizumab for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer.","BACKGROUND


First-line treatment of non-small-cell lung cancer (NSCLC) has undergone a paradigm shift to platinum combination therapy together with an immune checkpoint inhibitor (ICI). Bevacizumab is expected to enhance not only chemotherapy but also the efficacy of ICIs through blockade of vascular endothelial growth factor-mediated immunosuppression. We have now designed a randomized phase 3 study (APPLE, WJOG11218L, JapicCTI-194565) to evaluate the additional effect of bevacizumab administered together with platinum combination therapy and the ICI atezolizumab in patients with advanced nonsquamous NSCLC.
PATIENTS AND METHODS


Cytotoxic chemotherapy-naive patients aged 20 years or older with a performance status of 0 or 1 are randomly assigned in a 1:1 ratio to receive either atezolizumab plus pemetrexed/carboplatin or atezolizumab, pemetrexed/carboplatin, and bevacizumab. Patients with genetic driver alterations such as those affecting EGFR or ALK are included if they have experienced disease progression or unacceptable adverse effects during treatment with at least one approved tyrosine kinase inhibitor. After 4 cycles of induction therapy, maintenance therapy with atezolizumab plus pemetrexed or with atezolizumab, pemetrexed, and bevacizumab is administered for up to 2 years until evidence of disease progression or development of unacceptable toxicity. The primary end point is progression-free survival.
CONCLUSION


This is a phase 3 study to investigate the effect of adding bevacizumab to an ICI and platinum/pemetrexed combination therapy. If the primary objective is achieved, this study will provide a new standard treatment for cytotoxic chemotherapy-naive patients with advanced nonsquamous NSCLC.",2020,Bevacizumab is expected to enhance not only chemotherapy but also the efficacy of ICIs through blockade of vascular endothelial growth factor-mediated immunosuppression.,"['patients with advanced nonsquamous NSCLC', 'Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer', 'Cytotoxic chemotherapy-naive patients aged 20 years or older with a performance status of 0 or 1', 'non-small-cell lung cancer (NSCLC', 'Patients with genetic driver alterations such as those affecting EGFR or ALK', 'naive patients with advanced nonsquamous NSCLC']","['Bevacizumab', 'APPLE (WJOG11218L', 'atezolizumab plus pemetrexed/carboplatin or atezolizumab, pemetrexed/carboplatin, and bevacizumab', 'ICI and platinum/pemetrexed combination therapy', 'bevacizumab', 'Atezolizumab and Platinum/Pemetrexed With or Without Bevacizumab', 'cytotoxic chemotherapy', 'atezolizumab plus pemetrexed or with atezolizumab, pemetrexed, and bevacizumab', 'platinum combination therapy and the ICI atezolizumab']",['progression-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.129124,Bevacizumab is expected to enhance not only chemotherapy but also the efficacy of ICIs through blockade of vascular endothelial growth factor-mediated immunosuppression.,"[{'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Research and Development of Next Generation Medicine, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Hirano', 'Affiliation': 'Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Hospital, Amagasaki, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Hataji', 'Affiliation': 'Respiratory Center, Matsusaka Municipal Hospital, Matsusaka, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Motoko', 'Initials': 'M', 'LastName': 'Tachihara', 'Affiliation': 'Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. Electronic address: okamotoi@kokyu.med.kyushu-u.ac.jp.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.03.010']
63,32390559,Analysis of internal spermatic vein embolization through catheter versus laparoscopic high ligation in treatment of left varicocele.,"OBJECTIVE


Varicocele is a common disease in young and middle-aged men. This study aims to compare the efficacy of internal spermatic vein embolization of left varicocele versus laparoscopic high ligation.
METHODS


From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option. Among these, 26 patients were treated with sclerosing agent injection, while 43 patients underwent laparoscopic surgery. They were followed up for 12 months after surgery, and the technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time with regard to these two methods were analyzed.
RESULTS


All patients completed the medical procedures. There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%. Furthermore, the operative time, hospitalization time, and cost of treatment were 31.1 ± 11.1 min, 1.2 ± 0.49 days, and 9613.11 ± 895.97 Yuan, respectively. In the laparoscopic group, 9 patients underwent laparoscopic bilateral high ligation, while 34 patients received treatment on the left side alone. The recurrence rate of left varicocele was 4.7% and the complication rate was 44.2%. Furthermore, the operative time, hospitalization time, and treatment cost were 50.4 ± 14.48 min, 4.0 ± 2.02 days, and 10,948.29 ± 2547.00 Yuan, respectively. Moreover, there were statistically significant differences ( P  <   0.05) in operative time, hospitalization time, and treatment cost. Patients in the sclerotherapy group had an advantage with respect to the overall complication rate when compared with patients from the laparoscopic group ( X 2  = 4.448,  P  <   0.05), and there was a statistically significant difference in hydrocele ( X 2  = 4.555,  P  <   0.05). However, there was no significant difference in the recurrence rate between these two groups ( X 2  = 1.245,  P  >   0.05).
CONCLUSION


Patients who underwent sclerotherapy showed a higher technical success rate, a lower recurrence rate, fewer complications, and shorter hospitalization time compared to those treated with laparoscopic ligation. Transcatheter sclerosing agent injection may be a preferable treatment option for patients with unilateral varicocele.",2020,"There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%.","['patients with unilateral varicocele', 'young and middle-aged men', 'left varicocele', '26 patients were treated with sclerosing agent injection, while 43 patients underwent', 'From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option']","['Transcatheter sclerosing agent injection', 'laparoscopic bilateral high ligation', 'internal spermatic vein embolization through catheter versus laparoscopic high ligation', 'internal spermatic vein embolization of left varicocele versus laparoscopic high ligation', 'sclerotherapy', 'laparoscopic surgery']","['recurrence rate, fewer complications, and shorter hospitalization time', 'operative time, hospitalization time, and cost of treatment', 'recurrence rate of left varicocele', 'overall complication rate', 'technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time', 'technical success rate', 'complication rate', 'recurrence rate', 'operative time, hospitalization time, and treatment cost', 'hydrocele']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226718', 'cui_str': 'Structure of testicular vein'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1720771', 'cui_str': 'Hydrocele'}]",69.0,0.0594976,"There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%.","[{'ForeName': 'Ye-Xiang', 'Initials': 'YX', 'LastName': 'Jing', 'Affiliation': 'Department of Graduate School, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Zhao-Xuan', 'Initials': 'ZX', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}, {'ForeName': 'Qing-Yi', 'Initials': 'QY', 'LastName': 'Meng', 'Affiliation': 'Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China.'}]",Vascular,['10.1177/1708538120923548']
64,32388650,Effects of intraoperative positive end-expiratory pressure optimization on respiratory mechanics and the inflammatory response: a randomized controlled trial.,"Applying lung protective mechanical ventilation (LPV) during general anaesthesia even in patients with non-injured lungs is recommended. However, the effects of an individual PEEP-optimisation on respiratory mechanics, oxygenation and their potential correlation with the inflammatory response and postoperative complications have not been evaluated have not been compared to standard LPV in patients undergoing major abdominal surgery. Thirty-nine patients undergoing open radical cystectomy were enrolled in this study. In the study group (SG) optimal PEEP was determined by a decremental titration procedure and defined as the PEEP value resulting the highest static pulmonary compliance. In the control group (CG) PEEP was set to 6 cmH2O. Primary endpoints were intraoperative respiratory mechanics and gas exchange parameters. Secondary outcomes were perioperative procalcitonin kinetics and postoperative pulmonary complications. Optimal PEEP levels (median = 10, range: 8-14 cmH2O), PaO2/FiO2 (451.24 ± 121.78 mmHg vs. 404.15 ± 115.87 mmHg, P = 0.005) and static pulmonary compliance (52.54 ± 13.59 ml cmH2O-1 vs. 45.22 ± 9.13 ml cmH2O-1, P < 0.0001) were significantly higher, while driving pressure (8.26 ± 1.74 cmH2O vs. 9.73 ± 4.02 cmH2O, P < 0.0001) was significantly lower in the SG as compared to the CG. No significant intergroup differences were found in procalcitonin kinetics (P = 0.076). Composite outcome results indicated a non-significant reduction of postoperative complications in the SG. Intraoperative PEEP-optimization resulted in significant improvement in gas exchange and pulmonary mechanics as compared to standard LPV. Whether these have any effect on short and long term outcomes require further investigations. Trial registration: Clinicaltrials.gov, identifier: NCT02931409.",2020,No significant intergroup differences were found in procalcitonin kinetics (P = 0.076).,"['patients undergoing major abdominal surgery', 'Thirty-nine patients undergoing', 'patients with non-injured lungs']","['open radical cystectomy', 'intraoperative positive end-expiratory pressure optimization', 'lung protective mechanical ventilation (LPV', 'Intraoperative PEEP-optimization', 'individual PEEP-optimisation']","['intraoperative respiratory mechanics and gas exchange parameters', 'procalcitonin kinetics', 'driving pressure', 'postoperative complications', 'static pulmonary compliance', 'gas exchange and pulmonary mechanics', 'Optimal PEEP levels', 'perioperative procalcitonin kinetics and postoperative pulmonary complications', 'respiratory mechanics and the inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0974141,No significant intergroup differences were found in procalcitonin kinetics (P = 0.076).,"[{'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Ruszkai', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Pest Megyei Flór Ferenc Hospital, Semmelweis Square 1, Kistarcsa, 2143, Hungary. z.ruszkai.md@gmail.com.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Kiss', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University of Szeged, Semmelweis Street 6, Szeged, 6725, Hungary.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'László', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, University of Szeged, Semmelweis Street 6, Szeged, 6725, Hungary.'}, {'ForeName': 'Gergely Péter', 'Initials': 'GP', 'LastName': 'Bokrétás', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Dóra', 'Initials': 'D', 'LastName': 'Vizserálek', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Ildikó', 'Initials': 'I', 'LastName': 'Vámossy', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Surány', 'Affiliation': 'Department of Anaesthesiology and Intensive Therapy, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Buzogány', 'Affiliation': 'Department of Urology, Péterfy Sándor Hospital, Péterfy Sándor Street 8-20, Budapest, 1076, Hungary.'}, {'ForeName': 'Zoltán', 'Initials': 'Z', 'LastName': 'Bajory', 'Affiliation': 'Department of Urology, University of Szeged, Kálvária Avenue 57, Szeged, 6725, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': 'Centre for Translational Medicine, University of Pécs, Szigeti Street 12, Pécs, 7624, Hungary.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00519-6']
65,32396409,"A Prospective Randomized Controlled Trial of Irrigation ""Bag Squeeze"" to Manage Pain for Patients Undergoing Flexible Cystoscopy.","PURPOSE


We determined if the ""bag squeeze"" technique decreases pain during flexible cystoscopy in men.
MATERIALS AND METHODS


This single center, prospective, double-blind, randomized controlled trial recruited 200 consenting participants who were ambulatory, outpatient males who had undergone prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded from study. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the bag squeeze (group A) or the sham bag squeeze procedure (group B). Following cystoscopy, participants completed a pain questionnaire, visual analogue scale. Differences in mean pain score between groups were evaluated using Students' t-test with a 2-sided alpha of 0.05.
RESULTS


A total of 200 patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients 97 were randomized to bag squeeze (group A) and 93 to sham bag squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively (p <0.005).
CONCLUSIONS


This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.",2020,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","['Ten participants were ineligible because they required secondary procedures', 'Two hundred patients', 'Patients Undergoing Flexible Cystoscopy', '200 consenting participants who were ambulatory, outpatient males who had undergone a prior cystoscopy and were not expected to require any secondary procedures', '190 eligible patients, 97 were randomized to', 'men', 'Men with prior urethral stricture or bladder neck contracture']","['bag-squeeze', 'flexible cystoscopy', 'Irrigation ""Bag Squeeze', 'bag-squeeze"" technique', 'cystoscopy with the ""bag-squeeze"" (group A) or the sham bag-squeeze procedure', 'irrigation bag during a flexible cystoscopy']","['mean pain score', 'pain questionnaire: visual analogue scale', 'pain perception', 'pain']","[{'cui': 'C0445275', 'cui_str': 'Secondary procedure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0542404', 'cui_str': 'Stenosis of bladder neck'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",200.0,0.261447,"This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation ""bag-squeeze"" technique was employed versus placebo bag-squeeze.","[{'ForeName': 'Mohamad Baker', 'Initials': 'MB', 'LastName': 'Berajoui', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ishan', 'Initials': 'I', 'LastName': 'Aditya', 'Affiliation': 'University of Toronto, School of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'JaimeOmar', 'Initials': 'J', 'LastName': 'Herrera-Caceres', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yazan', 'Initials': 'Y', 'LastName': 'Qaoud', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Lajkosz', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ajib', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Glase', 'Affiliation': 'Department of Neurosciences, Carleton University, Ottawa, Ontario, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hersey', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Miran', 'Initials': 'M', 'LastName': 'Kenk', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hamilton', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Kulkarni', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Zlotta', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason Y', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Perlis', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Finelli', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Fleshner', 'Affiliation': 'Division of Urology, Department of Surgical Oncology, University Health Network, University of Toronto, Toronto, Ontario, Canada.'}]",The Journal of urology,['10.1097/JU.0000000000001139']
66,32396474,Factors Associated with HIV Disclosure Status Among iENGAGE Cohort of New to HIV Care Patients.,"HIV disclosure is an important behavior with implications for HIV treatment and prevention but understudied among new to HIV care patients who face unique challenges adjusting to a new diagnosis. This study evaluated the factors associated with HIV disclosure status and patterns of HIV disclosure among new to HIV care patients. A cross-sectional study was conducted evaluating the iENGAGE (integrating ENGagement and Adherence Goals upon Entry) cohort. Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016. The primary and secondary outcomes included HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure), respectively. Logistic and Multinomial Logistic Regression were used to evaluate the association of participant factors with HIV disclosure and patterns of HIV disclosure, respectively. Of 371 participants, the average age was 37 ± 12 years, 79.3% were males, and 62.3% were African Americans. A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers. In multivariable regression, black race, emotional support, and unmet needs predicted any HIV and broad disclosure, whereas males, emotional support, active coping, and acceptance were associated with selective disclosure. Interventions to promote early disclosure should focus on coping strategies and unmet needs, particularly among black and male people living with HIV initiating care.",2020,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","['Of 371 participants, the average age was 37\u2009±\u200912 years, 79.3% were males, and 62.3% were African Americans', 'Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016', 'black and male people living with HIV initiating care', 'HIV care patients']",[],"['HIV status', 'males, emotional support, active coping, and acceptance', 'HIV disclosure status and patterns of HIV disclosure', 'HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure', 'HIV Disclosure Status']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]",,0.0384234,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","[{'ForeName': 'Riddhi A', 'Initials': 'RA', 'LastName': 'Modi', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Willig', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Andrew O', 'Initials': 'AO', 'LastName': 'Westfall', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rivet', 'Initials': 'R', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Education, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Martin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Raper', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeanne C', 'Initials': 'JC', 'LastName': 'Keruly', 'Affiliation': 'Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zinski', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Crane', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}]",AIDS patient care and STDs,['10.1089/apc.2019.0271']
67,32335343,"Safety and efficacy of memantine for multiple sclerosis-related fatigue: A pilot randomized, double-blind placebo-controlled trial.","BACKGROUND


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


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


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


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


This trial failed to prove any clinical efficacy of memantine for the management of MS-related fatigue. Although memantine was generally well-tolerated, adverse events were among the major causes of dropout in this study.",2020,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","['multiple sclerosis-related fatigue', 'Sixteen patients in the memantine group and 24 patients in the', 'patients with MS', 'Sixty-four patients', 'patients with multiple sclerosis (MS', 'Eligible patients with relapsing-remitting MS (RRMS) according to the McDonald criteria']","['placebo', 'memantine']","['MFIS scores', 'tolerated, adverse events', 'Safety and efficacy', 'serious adverse events', 'safety and efficacy', 'severity of fatigue', 'dizziness and sedation', 'Modified Fatigue Impact Scale (MFIS']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960438', 'cui_str': 'Fatigue impact scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}]",64.0,0.542728,"The mean [95% CI] absolute change in MFIS scores from baseline did not differ significantly between the memantine (-5.8 [-12.7 to 1.0]) and placebo (-4.0 [-10.6 to 2.7]) groups (between-group difference: -1.9 [-11.7 to 7.8], P = .702).","[{'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Falsafi', 'Affiliation': 'Department of Neurology, Alavi Hospital, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Tafakhori', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elmira', 'Initials': 'E', 'LastName': 'Agah', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mojarrad', 'Affiliation': 'School of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reihaneh', 'Initials': 'R', 'LastName': 'Dehghani', 'Affiliation': 'Molecular Immunology Research Center, School of Medicine, Tehran University of Medical Science, Tehran 1419783151, Iran; Network of Immunity in Infection, Malignancy, and Autoimmunity (NIIMA), Universal Scientific Education and Research Network (USERN), Los Angeles, CA 90001, USA.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghaffarpour', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: ghafarpour@tums.ac.ir.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Aghamollaii', 'Affiliation': 'Department of Neurology, Roozbeh Hospital, Tehran University of Medical Sciences, Roozbeh Hospital, Tehran, Iran.'}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran; NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.""}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Fouladi', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Pourghaz', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pargol', 'Initials': 'P', 'LastName': 'Balali', 'Affiliation': ""Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Harirchian', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: harirchm@tums.ac.ir.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116844']
68,32303364,Learning how to break bad news from worked examples: Does the presentation format matter when hints are embedded? Results from randomised and blinded field trials.,"OBJECTIVES


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


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


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


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


In addition to video, text-based worked examples can effectively prepare students for BBN simulations if hints are included. This offers an affordable alternative to video examples, as text examples can be generated with less effort.",2020,"Prior to encountering SPs, the students worked through an e-learning module introducing the SPIKES protocol for delivering bad news; it contained the same worked example presented to either of four groups as text or video, with or without additional hints denoting the SPIKES steps being implemented.
","['One-hundred-and-forty-seven fourth-year medical students attending a BBN training participated in either of two equally scaffolded, randomised field trials']",[],[],"[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0282425', 'cui_str': 'News'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],147.0,0.0247783,"Prior to encountering SPs, the students worked through an e-learning module introducing the SPIKES protocol for delivering bad news; it contained the same worked example presented to either of four groups as text or video, with or without additional hints denoting the SPIKES steps being implemented.
","[{'ForeName': 'Felix Michael', 'Initials': 'FM', 'LastName': 'Schmitz', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: felix.schmitz@iml.unibe.ch.'}, {'ForeName': 'Kai Philipp', 'Initials': 'KP', 'LastName': 'Schnabel', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: kai.schnabel@iml.unibe.ch.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bauer', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: daniel.bauer@iml.unibe.ch.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Woermann', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: ulrich.woermann@iml.unibe.ch.'}, {'ForeName': 'Sissel', 'Initials': 'S', 'LastName': 'Guttormsen', 'Affiliation': 'Institute for Medical Education, University of Bern, 3010, Bern, Switzerland. Electronic address: sissel.guttormsen@iml.unibe.ch.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.022']
69,30485501,Cosyntropin testing does not predict response to glucocorticoids in community-acquired pneumonia in a randomized controlled trial.,"OBJECTIVE


Glucocorticoids have been shown to improve outcome in community-acquired pneumonia (CAP). However, glucocorticoids have potential side-effects, and treatment response may vary. It is thus crucial to select patients with high likelihood to respond favourably. In critical illness, cosyntropin testing is recommended to identify patients in need for glucocorticoids. We investigated whether cosyntropin testing predicts treatment response to glucocorticoids in CAP.
DESIGN


Predefined secondary analysis of a randomized controlled trial.
PATIENTS


Hospitalized patients with CAP.
MEASUREMENTS


We performed 1 µg cosyntropin tests in a randomized trial comparing prednisone 50 mg for 7 days to placebo. We investigated whether subgroups based on baseline and stimulated cortisol levels responded differently to glucocorticoids with regard to time to clinical stability (TTCS) and other outcomes by inclusion of interaction terms into statistical models.
RESULTS


A total of 326 patients in the prednisone and 309 patients in the placebo group were evaluated. Neither basal cortisol nor a Δcortisol <250 nmol/L after stimulation nor the combination of basal cortisol and Δcortisol predicted treatment response as measured by TTCS (all P for interaction >0.05). Similarly, we found no effect modification with respect to mortality, rehospitalization, antibiotic treatment duration or CAP-related complications (all P for interaction >0.05). However, glucocorticoids had a stronger effect on shortening length of hospital stay in patients with a baseline cortisol of ≥938 nmol/L (P for interaction = 0.015).
CONCLUSIONS


Neither baseline nor stimulated cortisol after low-dose cosyntropin testing at a dose of 1 µg predicted glucocorticoid responsiveness in mild to moderate CAP. A treatment decision for or against adjunct glucocorticoids in CAP should not be made depending on cortisol values or cosyntropin testing results.",2019,Neither baseline nor stimulated cortisol after low-dose cosyntropin testing at a dose of 1 µg predicted glucocorticoid responsiveness in mild to moderate CAP.,"['Hospitalized patients with CAP', '326 patients in the prednisone and 309 patients in the']","['glucocorticoids', 'Cosyntropin testing', 'placebo', 'prednisone', 'cosyntropin']","['basal cortisol', 'shortening length of hospital stay', 'mortality, rehospitalization, antibiotic treatment duration or CAP-related complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",326.0,0.226453,Neither baseline nor stimulated cortisol after low-dose cosyntropin testing at a dose of 1 µg predicted glucocorticoid responsiveness in mild to moderate CAP.,"[{'ForeName': 'Claudine A', 'Initials': 'CA', 'LastName': 'Blum', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Department of General Internal & Emergency Medicine and Department of Endocrinology, Diabetology and Clinical Nutrition, Medical University Clinic, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nigro', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Winzeler', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Birsen', 'Initials': 'B', 'LastName': 'Arici', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Refardt', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Sandrine A', 'Initials': 'SA', 'LastName': 'Urwyler', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Briel', 'Affiliation': 'Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Department of General Internal & Emergency Medicine and Department of Endocrinology, Diabetology and Clinical Nutrition, Medical University Clinic, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland.'}]",Clinical endocrinology,['10.1111/cen.13907']
70,31059146,Residual endogenous corticosteroid production in patients with adrenal insufficiency.,"OBJECTIVE


This study aimed at comparing precursors of endogenous corticosteroid production in patients with primary adrenal insufficiency and in secondary adrenal insufficiency.
DESIGN


Twenty patients with primary adrenal insufficiency and matched controls and 19 patients with secondary adrenal insufficiency participated in this ancillary analysis of two different studies.
PATIENTS AND MEASUREMENTS


Patients with primary adrenal insufficiency were on stable hydrocortisone and fludrocortisone therapy. Patients with secondary adrenal insufficiency received two different doses of hydrocortisone in a randomized crossover study. Main outcome measures were concentrations of precursors of cortisol and aldosterone measured by LC-MS/MS RESULTS: Compared to controls, progressively lower concentrations of the glucocorticoid precursors 11-deoxycortisol, 11-deoxycorticosterone and corticosterone concentrations were found in patients with secondary adrenal insufficiency on lower hydrocortisone dose, secondary adrenal insufficiency on higher hydrocortisone dose and primary adrenal insufficiency, respectively. Half of the primary adrenal insufficient patients showed evidence of residual endogenous cortisol or aldosterone synthesis, as determined by quantifiable 11-deoxycortisol, 11-deoxycorticosterone and corticosterone conce ntrations. In secondary adrenal insufficient patients with higher endogenous cortisol production, as indicated by 11-deoxycortisol concentrations above the median, no increased cortisol exposure was observed both by plasma pharmacokinetic parameters and 24-hour free cortisol excretion in urine.
CONCLUSIONS


Adrenal corticosteroid production is likely to continue during treatment in a considerable percentage of patients with both primary and secondary adrenal insufficiency. In patients with secondary adrenal insufficiency, this synthesis appears to be sensitive to the dose of hydrocortisone. However, the residual corticosteroid concentrations were quantitatively low and its clinical significance remains therefore to be determined.",2019,"Compared to controls, progressively lower concentrations of the glucocorticoid precursors 11-deoxycortisol, 11-deoxycorticosterone and corticosterone concentrations were found in patients with secondary adrenal insufficiency on lower hydrocortisone dose, secondary adrenal insufficiency on higher hydrocortisone dose and primary adrenal insufficiency, respectively.","['patients with secondary adrenal insufficiency', 'Patients with primary adrenal insufficiency were on stable', 'Twenty patients with primary adrenal insufficiency and matched controls and 19 patients with secondary adrenal insufficiency participated in this ancillary analysis of two different studies', 'Patients with secondary adrenal insufficiency', 'patients with both primary and secondary adrenal insufficiency', 'patients with adrenal insufficiency', 'patients with primary adrenal insufficiency and in secondary adrenal insufficiency']","['hydrocortisone', 'hydrocortisone and fludrocortisone therapy']","['endogenous cortisol production', 'plasma pharmacokinetic parameters and 24-hour free cortisol excretion', 'cortisol exposure', 'residual endogenous cortisol or aldosterone synthesis', '11-deoxycortisol concentrations', 'concentrations of precursors of cortisol and aldosterone measured by LC-MS/MS RESULTS', 'glucocorticoid precursors 11-deoxycortisol, 11-deoxycorticosterone and corticosterone concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271738', 'cui_str': 'Secondary adrenocortical insufficiency'}, {'cui': 'C0001403', 'cui_str': 'Hypoadrenalisms, Primary'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0001623', 'cui_str': 'Adrenal Insufficiency'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0016280', 'cui_str': 'Fludrocortisone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0443476', 'cui_str': 'Free cortisol (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0010139', 'cui_str': '11-Desoxycortisol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0011710', 'cui_str': 'desoxycortone'}, {'cui': 'C0373588', 'cui_str': 'Corticosterone measurement (procedure)'}]",20.0,0.024937,"Compared to controls, progressively lower concentrations of the glucocorticoid precursors 11-deoxycortisol, 11-deoxycorticosterone and corticosterone concentrations were found in patients with secondary adrenal insufficiency on lower hydrocortisone dose, secondary adrenal insufficiency on higher hydrocortisone dose and primary adrenal insufficiency, respectively.","[{'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Vulto', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ragnhildur', 'Initials': 'R', 'LastName': 'Bergthorsdottir', 'Affiliation': 'Department of Endocrinology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'van Faassen', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ido P', 'Initials': 'IP', 'LastName': 'Kema', 'Affiliation': 'Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gudmundur', 'Initials': 'G', 'LastName': 'Johannsson', 'Affiliation': 'Department of Endocrinology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'van Beek', 'Affiliation': 'Department of Endocrinology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",Clinical endocrinology,['10.1111/cen.14006']
71,32366224,"Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study.","BACKGROUND


Endotracheal intubation is known to pose significant physiological, pharmacokinetic, and dynamic changes and postoperative respiratory complications in patients under general anesthesia.
METHOD


An RCT trial was organized by the Third Affiliated Hospital at Sun Yat-sen University, China. Patients were eligible for inclusion in the trial if they were over 60 years old and had upper-abdominal surgery during the induction of anesthesia and had enrolled in endotracheal intubations. The primary end point included cardiovascular reactions during the induction of anesthesia and endotracheal intubations and cough events during the recovery period. In the test group, 2 g of lidocaine/prilocaine cream (and in the control group, 2 g of Vaseline) were laid over the surface of the tracheal tube cuff.
RESULTS


The systolic blood pressure (F value = 62.271, p < 0.001), diastolic blood pressure (F value = 150.875, p < 0.001), and heart rate (F value = 75.627, p < 0.001) of the test group were significantly lower than the control group. Cough events during the recovery period in the test group were better (spontaneous cough, χ 2  value = 10.591, p < 0.001; induced cough, χ 2  value =10.806, p < 0.001).
CONCLUSION


In older patients, coughing and cardiovascular reactions under anesthesia and endotracheal intubations were reduced, as a result of using lidocaine/prilocaine cream on the surface of the tracheal tube cuff.
TRIAL REGISTRATION


International Clinical Trials Network NCT02017392, 2013-12-16.",2020,"Cough events during the recovery period in the test group were better (spontaneous cough, χ 2  value = 10.591, p < 0.001; induced cough, χ 2  value =10.806, p < 0.001).
","['older patients under general anesthesia', 'Patients were eligible for inclusion in the trial if they were over 60\u2009years old and had upper-abdominal surgery during the induction of anesthesia and had enrolled in endotracheal intubations', '2013-12-16', 'patients under general anesthesia']","['lidocaine/prilocaine cream', 'Vaseline', 'placebo']","['coughing and cardiovascular reactions', 'heart rate', 'cardiovascular reactions during the induction of anesthesia and endotracheal intubations and cough events', 'systolic blood pressure', 'diastolic blood pressure', 'cardiovascular reactions from endotracheal intubation and cough events', 'Cough events']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0389615,"Cough events during the recovery period in the test group were better (spontaneous cough, χ 2  value = 10.591, p < 0.001; induced cough, χ 2  value =10.806, p < 0.001).
","[{'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Operation Room, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Shanghai Shyndec Pharmaceutical Co., Ltd, Shanghai, 600420, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. naturestyle@163.com.'}, {'ForeName': 'Miaoxia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. 1109986151@qq.com.'}]",BMC geriatrics,['10.1186/s12877-020-01567-y']
72,32379010,Feasibility of test administration and preliminary findings for cognitive control in the Burn 2 learn pilot randomised controlled trial.,"The feasibility requirements of administering field-based cognitive assessments are rarely reported. We examined the feasibility of administering a group-based cognitive test battery in a school setting with older adolescents. Several types of reliability were also assessed in the control group. Preliminary efficacy and the relationship between changes in fitness and changes in cognitive control were also explored following a 14-week HIIT intervention (3 sessions/week). Participants completed a cognitive test battery measuring inhibition (flanker), and working memory (n-back) at baseline and post-test. Health-related fitness assessments were also conducted. Test administration took approximately 30.8 ± 1.5 minutes to complete with up to six participants simultaneously. The test battery demonstrated acceptable reliability (ICC = 0.5-0.81), with significant changes observed for flanker incongruent accuracy, and 2-back non-target accuracy from baseline to post-test. Regarding efficacy, small-to-moderate effects were observed for accuracy outcomes, while several small associations were found between changes in fitness and changes in cognition. Findings from the current study suggest a cognitive test battery can be administered with older adolescents in a school setting. However, there remains a lack of adequate reporting of administration requirements for field-based cognitive assessments. Efficacy findings should be confirmed with a larger and more representative sample of older adolescents.",2020,"The test battery demonstrated acceptable reliability (ICC = 0.5-0.81), with significant changes observed for flanker incongruent accuracy, and 2-back non-target accuracy from baseline to post-test.","['older adolescents in a school setting', 'older adolescents', 'school setting with older adolescents']",[],"['acceptable reliability', 'cognitive test battery measuring inhibition (flanker), and working memory (n-back', 'flanker incongruent accuracy, and 2-back non-target accuracy', 'fitness and changes in cognition']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",6.0,0.0337063,"The test battery demonstrated acceptable reliability (ICC = 0.5-0.81), with significant changes observed for flanker incongruent accuracy, and 2-back non-target accuracy from baseline to post-test.","[{'ForeName': 'Angus A', 'Initials': 'AA', 'LastName': 'Leahy', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}, {'ForeName': 'Madieke F I', 'Initials': 'MFI', 'LastName': 'Michels', 'Affiliation': 'Chairgroup Health and Society, Wageningen University and Research , Wageningen, Netherlands.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Eather', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University , Boston, MA, USA.'}, {'ForeName': 'Tatsuya T', 'Initials': 'TT', 'LastName': 'Shigeta', 'Affiliation': 'Department of Psychology, Northeastern University , Boston, MA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Smith', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756673']
73,32383125,Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial.,"BACKGROUND


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


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


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


clinicaltrials.gov (NCT04308668); registered 16 March, 2020.",2020,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'symptomatic outpatients with COVID-19 showing symptoms for less than four days', '1,500 patients each for the PEP and PET trials']","['hydroxychloroquine or placebo', 'Post-exposure prophylaxis or pre-emptive therapy', 'hydroxychloroquine', 'hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET', 'placebo']","['incidence of symptomatic COVID-19', 'ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1500.0,0.697151,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"[{'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada. slother@manitoba-physicians.ca.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Agostinis', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases & Medical Microbiology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics and Child Health, Department of Pharmacology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'Critical Care Research, St-Boniface Hospital, Winnipeg, MB, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Schwartz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Centre, Population Health and Optimal Health Practices Research Unit Trauma - Emergency - Critical Care Medicine, Université Laval, Quebec, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01684-7']
74,32319997,High Rates of Off-label Prescribing and the Urgent Need for a Randomized Clinical Trial.,,2020,,[],[],['High Rates of Off-label'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1096117', 'cui_str': 'Off label use'}]",,0.203738,,"[{'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Associate Editor.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0612']
75,32322920,"[Intensity-modulated fractionated radiotherapy vs. stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomized, open-label, phase 3, noninferiority trial].",,2020,,[],['Intensity-modulated fractionated radiotherapy vs. stereotactic body radiotherapy'],[],[],"[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]",[],,0.0827106,,"[{'ForeName': 'Gerhard G', 'Initials': 'GG', 'LastName': 'Grabenbauer', 'Affiliation': 'Strahlentherapie & Radioonkologie am Klinikum Coburg, Ketschendorfer Straße\xa033, 96450, Coburg, Deutschland. gg@diestrahlentherapeuten.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01616-w']
76,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3']
77,32338720,Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial.,"Importance


Cycled (intermittent) phototherapy (PT) might adequately control peak total serum bilirubin (TSB) level and avoid mortality associated with usual care (continuous PT) among extremely low-birth-weight (ELBW) infants (401-1000 g).
Objective


To identify a cycled PT regimen that substantially reduces PT exposure, with an increase in mean peak TSB level lower than 1.5 mg/dL in ELBW infants.
Design, Setting, and Participants


This dose-finding randomized clinical trial of cycled PT vs continuous PT among 305 ELBW infants in 6 US newborn intensive care units was conducted from March 12, 2014, to November 14, 2018.
Interventions


Two cycled PT regimens (≥15 min/h and ≥30 min/h) were provided using a simple, commercially available timer to titrate PT minutes per hour against TSB level. The comparator arm was usual care (continuous PT).
Main Outcomes and Measures


Mean peak TSB level and total PT hours through day 14 in all 6 centers and predischarge brainstem auditory-evoked response wave V latency in 1 center. Mortality and major morbidities were secondary outcomes despite limited power.
Results


Consent was requested for 452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749 [152] g; gestational age, 25.7 [1.9] weeks; 81 infants [27%] were multiple births; 137 infants [45%] were male; 112 [37%] were black infants; and 107 [35%] were Hispanic infants). Clinical and demographic characteristics of the groups were similar at baseline. After a preplanned interim analysis of 100 infants, the regimen of 30 min/h or more was discontinued, and the study proceeded with 2 arms. Comparing 128 infants receiving PT of 15 min/h or more with 128 infants receiving continuous PT among those surviving to 14 days, mean peak TSB levels were 7.1 vs 6.4 mg/dL (adjusted difference, 0.7; 95% CI, 0.4-1.1 mg/dL) and mean total PT hours were 34 vs 72 (adjusted difference, -39; 95% CI, -45 to -32). Wave V latency adjusted for postmenstrual age was similar in 37 infants receiving 15 min/h or more of PT and 33 infants receiving continuous PT: 7.42 vs 7.32 milliseconds (difference, 0.10; 95% CI, -0.11 to 0.30 millisecond). The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0). Morbidities did not differ between groups.
Conclusions and Relevance


Cycled PT can substantially reduce total PT with little increase in peak TSB level. A large, randomized trial is needed to assess whether cycled PT would increase survival and survival without impairment in small, preterm infants.
Trial Registration


ClinicalTrials.gov Identifier: NCT01944696.",2020,"The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0).","['152', 'small, preterm infants', 'Extremely Low-Birth-Weight Infants', '305 ELBW infants in 6 US newborn intensive care units was conducted from March 12, 2014, to November 14, 2018', '128 infants receiving PT of 15 min/h or more with 128 infants receiving', '452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749', 'g; gestational age, 25.7 [1.9] weeks; 81 infants [27%] were multiple births; 137 infants [45%] were male; 112 [37%] were black infants; and 107 [35%] were Hispanic infants']","['continuous PT', 'cycled PT vs continuous PT', 'Importance\n\n\nCycled (intermittent) phototherapy (PT']","['TSB) level and avoid mortality associated with usual care (continuous PT', 'peak TSB level', 'survival and survival', 'mean peak TSB levels', 'Measures\n\n\nMean peak TSB level and total PT hours through day 14 in all 6 centers and predischarge brainstem auditory-evoked response wave V latency', 'peak total serum bilirubin', 'relative risk for death', 'mean total PT hours', 'Mortality and major morbidities', 'mean peak TSB level', 'Morbidities']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026753', 'cui_str': 'Multiple Births'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0079319', 'cui_str': 'Brain stem auditory evoked potential'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",452.0,0.186731,"The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of -4.5% (95% CI, -10.9 to 2.0).","[{'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Arnold', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Wally A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Birmingham School of Medicine, University of Alabama, Birmingham.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Stevenson', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Dempsey', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Fonseca', 'Affiliation': 'University of Texas Medical Branch at Galveston.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Wyckoff', 'Affiliation': 'University of Texas Southwestern Medical School, Dallas.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreira', 'Affiliation': 'University of Texas Health Science Center at San Antonio.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lasky', 'Affiliation': 'McGovern Medical School, University of Texas, Houston.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0559']
78,31690523,Randomized controlled trial of vacuum therapy for intermittent claudication.,"OBJECTIVE


The ""gold standard"" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program.
METHODS


IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life.
RESULTS


A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups.
CONCLUSIONS


IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.",2020,"Ambulatory ability and quality of life improved equally in both groups.
","['IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017', '78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n\xa0= 34; intervention, n\xa0= 36', 'IC patients undergoing a standardized SET program', 'intermittent claudication']","['intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure', 'Intermittent vacuum therapy (IVT', 'standardized SET program', 'vacuum therapy', 'supervised exercise therapy (SET', 'IVT']","['functional treadmill walking distance', 'negative pressure and atmospheric pressure', 'walking distance', 'change in maximal treadmill walking distance', 'change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life', 'Ambulatory ability and quality of life', 'Median (interquartile range) change in maximal treadmill walking distance', 'Mean\xa0± standard deviation change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0004180', 'cui_str': 'Atmospheric Pressure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034380'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",78.0,0.184491,"Ambulatory ability and quality of life improved equally in both groups.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hageman', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hugo J P', 'Initials': 'HJP', 'LastName': 'Fokkenrood', 'Affiliation': 'Department of Vascular Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Brit A C', 'Initials': 'BAC', 'LastName': 'van Deursen', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Lindy N M', 'Initials': 'LNM', 'LastName': 'Gommans', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Cancrinus', 'Affiliation': 'Department of Vascular Surgery, St. Anna Hospital, Geldrop, The Netherlands.'}, {'ForeName': 'Marc R M', 'Initials': 'MRM', 'LastName': 'Scheltinga', 'Affiliation': 'Department of Vascular Surgery, Máxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Joep A W', 'Initials': 'JAW', 'LastName': 'Teijink', 'Affiliation': 'Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands; Department of Epidemiology, CAPHRI School for Public Health and Primary Care, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands. Electronic address: joep.teijink@catharinaziekenhuis.nl.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.08.239']
79,32321451,Successful implementation of an enhanced recovery after surgery (ERAS) protocol reduces nausea and vomiting after infratentorial craniotomy for tumour resection: a randomized controlled trial.,"BACKGROUND


Infratentorial craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). Enhanced Recovery After Surgery (ERAS) protocols have been shown in multiple surgical disciplines to improve outcomes, including reduced PONV. However, very few studies have described the application of ERAS to infratentorial craniotomy. The aim of this study was to examine whether our ERAS protocol for infratentorial craniotomy could improve PONV.
METHODS


We implemented an evidence-based, multimodal ERAS protocol for patients undergoing infratentorial craniotomy. A total of 105 patients who underwent infratentorial craniotomy were randomized into either the ERAS group (n = 50) or the control group (n = 55). Primary outcomes were the incidence of vomiting, nausea score, and use of rescue antiemetic during the first 72 h after surgery. Secondary outcomes included postoperative anxiety level, sleep quality, and complications.
RESULTS


Over the entire 72 h post-craniotomy observation period, the cumulative incidence of vomiting was significantly lower in the ERAS group than in the control group. Meanwhile, the incidence of vomiting was significantly lower in the ERAS group on postoperative days (PODs) 2 and 3. Notably, the proportion of patients with mild nausea (VAS 0-4) was higher in the ERAS group as compared to the control group on PODs 2 or 3. Additionally, the postoperative anxiety level and quality of sleep were significantly better in the ERAS group.
CONCLUSION


Successful implementation of our ERAS protocol in infratentorial craniotomy patients could attenuate postoperative anxiety, improve sleep quality, and reduce the incidence of PONV, without increasing the rate of postoperative complications.
TRIAL REGISTRATION


ChiCTR-INR-16009662, 27 Oct 2016, Clinical study on the development and efficacy evaluation of Enhanced Recovery After Surgery (ERAS) in Neurosurgery.",2020,"Successful implementation of our ERAS protocol in infratentorial craniotomy patients could attenuate postoperative anxiety, improve sleep quality, and reduce the incidence of PONV, without increasing the rate of postoperative complications.
","['infratentorial craniotomy patients', 'patients undergoing infratentorial craniotomy', '105 patients who underwent infratentorial craniotomy', 'after infratentorial craniotomy for tumour resection']","['ERAS', 'Enhanced Recovery', 'surgery (ERAS) protocol']","['postoperative nausea and vomiting (PONV', 'cumulative incidence of vomiting', 'incidence of vomiting', 'incidence of vomiting, nausea score, and use of rescue antiemetic', 'postoperative anxiety level, sleep quality, and complications', 'mild nausea', 'incidence of PONV', 'postoperative anxiety level and quality of sleep', 'nausea and vomiting', 'Enhanced Recovery', 'postoperative anxiety, improve sleep quality']","[{'cui': 'C0441939', 'cui_str': 'Infratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",105.0,0.10403,"Successful implementation of our ERAS protocol in infratentorial craniotomy patients could attenuate postoperative anxiety, improve sleep quality, and reduce the incidence of PONV, without increasing the rate of postoperative complications.
","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tianzhi', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Nutrition, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lanfu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Binfang', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Mingjuan', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhengmin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jiangtao', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Wenhai', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xude', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Shaanxi Provincial People's Hospital, Xi'an, China. slash0704@sina.com.cn.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, Xi'an, China. he-shiming@163.com.""}]",BMC neurology,['10.1186/s12883-020-01699-z']
80,32333328,The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial.,"INTRODUCTION


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


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


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


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


ClinicalTrials.gov identifier, NCT01929031.",2020,"SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups.","['patients with moderate or severe baseline pain', ""patients with moderate or severe pain, which was determined on a 4-point verbal rating scale ('no pain' to 'severe pain"", '237 patients with moderate pain and 325 with severe pain at baseline', 'Patients with Acute Postoperative Dental Pain', 'patients with moderate intensity pain at baseline, and also evident in patients with severe baseline pain']","['ibuprofen', 'ibuprofen 400\xa0mg and caffeine', 'FDC versus ibuprofen, caffeine and placebo', 'ibuprofen/caffeine FDC versus ibuprofen', 'Ibuprofen/Caffeine', 'FDC versus ibuprofen', 'ibuprofen 400\xa0mg/caffeine 100\xa0mg FDC, ibuprofen 400\xa0mg, caffeine 100\xa0mg or placebo']","['analgesic efficacy', 'Pain relief (PAR) and pain intensity', 'moderate pain, PID', 'PID', 'time-weighted sum of PAR and pain intensity difference (PID']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0984276', 'cui_str': 'Caffeine 100 MG'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",237.0,0.652098,"SPRID 0-8h  was significantly improved with the FDC versus ibuprofen, caffeine and placebo in the moderate and severe pain subgroups.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Förderreuther', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians University, Munich, Germany. sfoerder@med.uni-muenchen.de.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Lampert', 'Affiliation': 'Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hitier', 'Affiliation': 'Global Medical Consumer Health Care, Sanofi-Aventis Groupe, Gentilly, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Global Medical Affairs, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weiser', 'Affiliation': 'Medical Consumer Health Care, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01297-y']
81,32312243,"Design of the WHIP-PD study: a phase II, twelve-month, dual-site, randomized controlled trial evaluating the effects of a cognitive-behavioral approach for promoting enhanced walking activity using mobile health technology in people with Parkinson-disease.","BACKGROUND


Parkinson disease (PD) is a debilitating and chronic neurodegenerative disease resulting in ambulation difficulties. Natural walking activity often declines early in disease progression despite the relative stability of motor impairments. In this study, we propose a paradigm shift with a ""connected behavioral approach"" that targets real-world walking using cognitive-behavioral training and mobile health (mHealth) technology.
METHODS/DESIGN


The Walking and mHealth to Increase Participation in Parkinson Disease (WHIP-PD) study is a twelve-month, dual site, two-arm, randomized controlled trial recruiting 148 participants with early to mid-stage PD. Participants will be randomly assigned to connected behavioral or active control conditions. Both conditions will include a customized program of goal-oriented walking, walking-enhancing strengthening exercises, and eight in-person visits with a physical therapist. Participants in the connected behavioral condition also will (1) receive cognitive-behavioral training to promote self-efficacy for routine walking behavior and (2) use a mHealth software application to manage their program and communicate remotely with their physical therapist. Active control participants will receive no cognitive-behavioral training and manage their program on paper. Evaluations will occur at baseline, three-, six-, and twelve-months and include walking assessments, self-efficacy questionnaires, and seven days of activity monitoring. Primary outcomes will include the change between baseline and twelve months in overall amount of walking activity (mean number of steps per day) and amount of moderate intensity walking activity (mean number of minutes per day in which > 100 steps were accumulated). Secondary outcomes will include change in walking capacity as measured by the six-minute walk test and ten-meter walk test. We also will examine if self-efficacy mediates change in amount of walking activity and if change in amount of walking activity mediates change in walking capacity.
DISCUSSION


We expect this study to show the connected behavioral approach will be more effective than the active control condition in increasing the amount and intensity of real-world walking activity and improving walking capacity. Determining effective physical activity interventions for persons with PD is important for preserving mobility and essential for maintaining quality of life. Clinical trials registration NCT03517371, May 7, 2018.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03517371. Date of registration: May 7, 2018. Protocol version: Original.",2020,Secondary outcomes will include change in walking capacity as measured by the six-minute walk test and ten-meter walk test.,"['148 participants with early to mid-stage PD', 'persons with PD', 'people with Parkinson-disease']","['cognitive-behavioral approach', 'cognitive-behavioral training', 'routine walking behavior and (2) use a mHealth software application to manage their program and communicate remotely with their physical therapist', 'connected behavioral or active control conditions', 'cognitive-behavioral training and manage their program on paper', 'connected behavioral approach"" that targets real-world walking using cognitive-behavioral training and mobile health (mHealth) technology']","['walking assessments, self-efficacy questionnaires, and seven days of activity monitoring', 'overall amount of walking activity (mean number of steps per day) and amount of moderate intensity walking activity', 'change in walking capacity as measured by the six-minute walk test and ten-meter walk test']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}]",148.0,0.0743652,Secondary outcomes will include change in walking capacity as measured by the six-minute walk test and ten-meter walk test.,"[{'ForeName': 'Kerri S', 'Initials': 'KS', 'LastName': 'Rawson', 'Affiliation': 'Program in Physical Therapy, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'James T', 'Initials': 'JT', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Physical Therapy, University of New England, Portland, ME, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colon-Semenza', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'DeAngelis', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Duncan', 'Affiliation': 'Program in Physical Therapy, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fulford', 'Affiliation': 'Department of Occupational Therapy, Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaValley', 'Affiliation': 'School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Neurology, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Nordahl', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Quintiliani', 'Affiliation': 'Department of Medicine, Section of General Internal Medicine, Boston University, Boston, MA, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': ""Department of Neurology, Parkinson's Disease and Movement Disorders Center, Boston University, Boston, MA, USA.""}, {'ForeName': 'Cathi A', 'Initials': 'CA', 'LastName': 'Thomas', 'Affiliation': ""Department of Neurology, Parkinson's Disease and Movement Disorders Center, Boston University, Boston, MA, USA.""}, {'ForeName': 'Gammon M', 'Initials': 'GM', 'LastName': 'Earhart', 'Affiliation': 'Program in Physical Therapy, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Terry D', 'Initials': 'TD', 'LastName': 'Ellis', 'Affiliation': 'Department of Physical Therapy and Athletic Training, Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, USA. tellis@bu.edu.'}]",BMC neurology,['10.1186/s12883-020-01718-z']
82,32330749,Human gut microbiome composition and tryptophan metabolites were changed differently by fast food and Mediterranean diet in 4 days: a pilot study.,"Diets rich in animal source foods vs plant-based diets have different macronutrient composition, and they have been shown to have differential effects on the gut microbiome. In this study, we hypothesized that diets with very different nutrient composition are able to change gut microbiome composition and metabolites in a very short period. We compared a fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish. Ten healthy subjects participated in a controlled crossover study in which they consumed a Med diet and FF diet in randomized order for 4 days each, with a 4-day washout between treatments. Fecal DNA was extracted and the 16S V4 region amplified using polymerase chain reaction followed by sequencing on an Illumina MiSeq. Plasma metabolites and bile acids were analyzed using liquid chromatography-mass spectrometry. Certain bile-tolerant microbial genera and species including Collinsella, Parabacteroides, and Bilophila wadsworthia significantly increased after the FF diet. Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet. Bacterially produced metabolites indole-3-lactic acid and indole-3-propionic acid, which have been shown to confer beneficial effects on neuronal cells, increased after the Med diet and decreased after the FF diet. Interindividual variability in response to the treatments may be related to differences in background diet, for example as shown by differences in Bilophila response in relationship to the saturated fat content of the baseline diet. In conclusion, an animal fat-rich, low-fiber FF diet v. a high-fiber Med diet altered human gut microbiome composition and its metabolites after just 4 days.",2020,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.",['Ten healthy subjects'],"['fast food (FF) diet (ie, burgers and fries) with a Mediterranean (Med) diet, which is rich in vegetables, whole grains, olive oil, nuts, and fish', 'Med diet and FF diet']","['Collinsella, Parabacteroides, and Bilophila wadsworthia', 'Plasma metabolites and bile acids']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452929', 'cui_str': 'Burger'}, {'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C1047126', 'cui_str': 'Collinsella'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C1005848', 'cui_str': 'Bilophila wadsworthia'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}]",10.0,0.0227447,"Some fiber-fermenting bacteria, including Lachnospiraceae and Butyricicoccus, increased significantly after the Med diet and decreased after the FF diet.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: egbeals@ucdavis.edu.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chrhodes@ucdavis.edu.'}, {'ForeName': 'Hannah Eve', 'Initials': 'HE', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: rsacchi@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.03.005']
83,32324981,"Safety and Efficacy of Revefenacin and Formoterol in Sequence and Combination via a Standard Jet Nebulizer in Patients with Chronic Obstructive Pulmonary Disease: A Phase 3b, Randomized, 42-Day Study.","Although no nebulized, dual mechanism, long-acting bronchodilator is currently marketed, with the approval of once-daily long-acting muscarinic antagonist (LAMA) revefenacinefenacin, it is theoretically possible to deliver a LAMA and long-acting beta2-agonist via standard jet nebulizer. The primary and secondary objectives of our study were to characterize the safety profile of revefenacin administered sequentially before or in combination with formoterol, via standard jet nebulizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). In this randomized, double-blind, 42-day trial (NCT03573817), patients received revenacin 175 µg (n=63) or placebo (n=59), followed by formoterol 20 µg in the morning and formoterol alone in the evening formoterol 21 days via standard jet nebulizer (sequential administration). For another 21 days, revefenacin/placebo and formoterol, were administered as mixed solutions via single nebulization in the morning (combined administration), and formoterol alone in the evening. The adverse events' (AEs) incidence was higher in the placebo + formoterol arms (11%-12%) than in the revefenacin + formoterol arms (5%-8%). The most common AEs were worsening/exacerbation of COPD, cough, and dizziness. There were no serious AEs or deaths reported in any arm. The least squares mean in trough forced expiratory volume in 1 second (FEV 1 ) versus baseline was higher in the revefenacin + formoterol arms (116-157 mL) than in the placebo + formoterol arms (35-53 mL). Revefenacin had a safety profile similar to formoterol alone when delivered sequentially or combined. Trough FEV 1  was similar when revefenacin was delivered sequentially or combined with formoterol, with revefenacin providing an additional 81-104 mL improvements over formoterol alone.",2020,The least squares mean in trough forced expiratory volume in 1 second (FEV 1 ) versus baseline was higher in the revefenacin + formoterol arms,"['patients with moderate to very severe chronic obstructive pulmonary disease (COPD', 'Patients with Chronic Obstructive Pulmonary Disease']","['revefenacin', 'formoterol, with revefenacin', 'formoterol 20 µg in the morning and formoterol alone in the evening formoterol 21 days via standard jet nebulizer (sequential administration', 'placebo + formoterol', 'formoterol, via standard jet nebulizer', 'revefenacin/placebo and formoterol', 'revenacin 175 µg (n=63) or placebo', 'revefenacin + formoterol', 'Revefenacin and Formoterol', 'Revefenacin']","['worsening/exacerbation of COPD, cough, and dizziness', 'serious AEs or deaths', 'Trough', 'Safety and Efficacy', ""adverse events' (AEs) incidence""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C4519232', 'cui_str': 'revefenacin'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.722409,The least squares mean in trough forced expiratory volume in 1 second (FEV 1 ) versus baseline was higher in the revefenacin + formoterol arms,"[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Siler', 'Affiliation': 'Midwest Chest Consultants, PC, St Charles, Missouri.'}, {'ForeName': 'Edmund J', 'Initials': 'EJ', 'LastName': 'Moran', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Crater', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.7.2.2019.0154']
84,32324983,"ELLIPTA Versus DISKUS plus HandiHaler in COPD: A Randomized, Open-Label, Crossover Study in a Clinical Trial Setting.","Background


Inhaler errors among patients with chronic obstructive pulmonary disease (COPD) can reduce treatment efficacy.
Methods


This randomized, open-label, crossover study evaluated correct use of ELLIPTA versus DISKUS plus HandiHaler. Participants with COPD attended at least 3 study visits (Day 1 [Visit 1], Day 28 [Visit 2], and Day 56 [Visit 3]). Inhalers contained placebo; usual maintenance medication was continued. Participants were randomized to an inhaler sequence (ELLIPTA then DISKUS plus HandiHaler, or the reverse) and preference questionnaire at Visit 1. Participants read the instructions for use in the approved prescribing information for their inhaler(s) and correct use was assessed at Visit 1 (verbal guidance provided if required). Correct use was reassessed at Visit 2, and with the next inhaler(s) at Visit 3. Primary endpoint was the proportion of participants demonstrating correct use (0 errors) with the assigned inhaler(s) after 28 days.
Results


A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days. The odds of demonstrating correct use with ELLIPTA were 6.88 times that of DISKUS plus HandiHaler ( p  < 0.001). Overall, > 99% of participants made 0 critical errors (errors leading to no or significantly reduced medication inhaled) with ELLIPTA versus 89% with DISKUS plus HandiHaler after 28 days. ELLIPTA was the patient-preferred option versus DISKUS plus HandiHaler or no preference ( p  < 0.001).
Conclusions


Delivery of COPD maintenance therapy via ELLIPTA demonstrates higher correct use rates and lower critical error rates compared with DISKUS plus HandiHaler.",2020,A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days.,"['COPD', 'Participants with COPD attended at least 3 study visits (Day 1 [Visit 1], Day 28 [Visit 2], and Day 56 [Visit 3', 'patients with chronic obstructive pulmonary disease (COPD']","['COPD maintenance therapy via ELLIPTA', 'inhaler sequence (ELLIPTA then DISKUS plus HandiHaler, or the reverse) and preference questionnaire at Visit 1', 'ELLIPTA versus DISKUS plus HandiHaler', 'placebo', 'ELLIPTA']",['proportion of participants demonstrating correct use (0 errors'],"[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",217.0,0.101647,A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days.,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford.'}, {'ForeName': 'Selwyn', 'Initials': 'S', 'LastName': 'Spangenthal', 'Affiliation': 'American Health Research, Charlotte, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zvarich', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, Durham, North Carolina.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Millar', 'Affiliation': 'GlaxoSmithKline plc., Uxbridge, United Kingdom.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, Durham, North Carolina.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collison', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, Durham, North Carolina.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Respiratory Medical Franchise, GlaxoSmithKline plc., Brentford, United Kingdom.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.7.2.2019.0153']
85,32274653,"Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects.","BACKGROUND AND OBJECTIVE


Peficitinib pharmacokinetics and pharmacodynamics have been characterized mainly in Caucasian subjects. This study investigated the pharmacokinetics, pharmacodynamics, safety, and tolerability of peficitinib in healthy Japanese subjects compared with Caucasian subjects.
METHODS


In this single-center, randomized, double-blind, placebo-controlled study, a cohort of healthy Japanese (n = 24) and Caucasian (n = 24) men received a single oral dose of peficitinib (20, 60, or 200 mg) or placebo. Another cohort of Japanese men (n = 24) received peficitinib (10, 30, or 100 mg) or placebo twice daily for 7 days. Pharmacokinetic and pharmacodynamic parameters were assessed, and adverse events (AEs) monitored throughout.
RESULTS


Dose proportionality of maximum plasma drug concentration (C max ) and area under the plasma concentration-time curve extrapolated to infinity (AUC inf ) was demonstrated for both ethnicities. The geometric mean ratio for dose-normalized C max  was 45.7-98.8% higher and AUC inf  was 33.8-66.4% higher in Japanese versus Caucasian subjects. Mean peak inhibition of STAT5 phosphorylation was higher in Japanese than Caucasian subjects for a given peficitinib dose, but inhibition was comparable across ethnicities for a given plasma peficitinib concentration. In the multiple-dose study, plasma peficitinib concentrations were similar on day 1 and day 7. All AEs were mild, and none resulted in study discontinuation.
CONCLUSIONS


Peficitinib was well tolerated at doses up to 200 mg daily for 7 days in healthy Japanese subjects. Dose-proportional exposure was demonstrated across the single-dose range of 20-200 mg, with greater peficitinib exposure in Japanese compared with Caucasian subjects. The pharmacokinetic/pharmacodynamic relationships were considered comparable between these populations. CLINICALTRIALS.
GOV IDENTIFIER


NCT01225224.",2020,"Mean peak inhibition of STAT5 phosphorylation was higher in Japanese than Caucasian subjects for a given peficitinib dose, but inhibition was comparable across ethnicities for a given plasma peficitinib concentration.","['healthy Japanese subjects compared with Caucasian subjects', 'Another cohort of Japanese men (n\u2009=\u200924) received', 'Healthy Male Caucasian and Japanese Subjects', 'healthy Japanese subjects', 'Caucasian subjects', 'cohort of healthy Japanese (n\u2009=\u200924) and Caucasian (n\u2009=\u200924) men received a']","['Peficitinib (ASP015K', 'peficitinib', 'single oral dose of peficitinib', 'placebo']","['Pharmacokinetic and pharmacodynamic parameters', 'geometric mean ratio for dose-normalized C max', 'Mean peak inhibition of STAT5 phosphorylation', 'pharmacokinetics, pharmacodynamics, safety, and tolerability of peficitinib', 'Pharmacokinetics, Pharmacodynamics, and Safety', 'AUC inf', 'maximum plasma drug concentration (C max ) and area under the plasma concentration-time curve extrapolated to infinity (AUC inf ', 'plasma peficitinib concentrations']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C4505523', 'cui_str': 'ASP015K'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1366394', 'cui_str': 'STAT5A protein, human'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4505522', 'cui_str': 'peficitinib'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.18269,"Mean peak inhibition of STAT5 phosphorylation was higher in Japanese than Caucasian subjects for a given peficitinib dose, but inhibition was comparable across ethnicities for a given plasma peficitinib concentration.","[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Shibata', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan. mai.shibata@astellas.com.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hatta', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Oda', 'Affiliation': 'Astellas Research Institute of America LLC, 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411, Japan.'}]",Clinical drug investigation,['10.1007/s40261-020-00910-w']
86,32389633,Decreasing Cesarean Delivery Rates Using a Trial of Labour After Cesarean (TOLAC) Bundle.,"OBJECTIVE


To develop and implement a trial of labour after cesarean delivery (TOLAC) bundle-a group of interventions aimed at decreasing cesarean delivery (CD) for women who have had a prior CD (Robson group 5).
METHODS


A TOLAC bundle was developed that included: (1) educational rounds for health care providers, (2) a physician-patient TOLAC discussion aid, and (3) patient-centred educational resources. A before-and-after study design was employed. A one-year chart review determined baseline CD rates in Robson group 5 patients at a tertiary care academic centre. Following this, from February 1, 2018 until May 31, 2019, each bundle intervention was sequentially introduced every four to six months and modified based on provider feedback. Obstetricians were provided with their individual CD rates using an audit-and-feedback approach prior to the introduction of the next intervention.
RESULTS


The baseline CD rate for Robson group 5 patients was 71% (175/247 eligible patients). Following the introduction of the bundle, the CD rate decreased to 61% (131/214 eligible patients). This was a 10% decrease in the CD rate (P = 0.029). A significant increase in rate of induction was noted, from 5% pre-intervention to 11% post-intervention (p = 0.017). There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission.
CONCLUSIONS


A TOLAC bundle, consisting of provider education, a TOLAC discussion aid, and patient resources, combined with audit and feedback, decreased CD for Robson group 5 patients.",2020,"There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission.
","['women who have had a prior CD (Robson group 5', 'Robson group 5 patients at a tertiary care academic centre']","['labour after cesarean delivery (TOLAC) bundle-a group of interventions aimed at decreasing cesarean delivery (CD', 'Labour']","['baseline CD rate', 'CD rate', 'rate of induction', 'Decreasing Cesarean Delivery Rates', 'rates of uterine rupture or NICU admission', 'rate of vaginal birth', 'baseline CD rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042143', 'cui_str': 'Rupture of uterus'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",,0.0265818,"There were no significant decreases in the rate of vaginal birth after CD or increases in the rates of uterine rupture or NICU admission.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miazga', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON. Electronic address: elizabeth.miazga@mail.utoronto.ca.'}, {'ForeName': 'Cheyanne', 'Initials': 'C', 'LastName': 'Reed', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, ON.'}, {'ForeName': 'Modupe', 'Initials': 'M', 'LastName': 'Tunde-Byass', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, North York General Hospital, North York, ON.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Cipolla', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, Trillium Health Partners, Mississauga, ON.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynecology, Mount Sinai Hospital, Toronto, ON.'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Shore', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Department of Obstetrics and Gynaecology, St. Michael's Hospital, Toronto, ON.""}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.02.113']
87,32333853,Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial.,"BACKGROUND


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


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


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


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


URL: http://www.controlled-trials.com. Unique identifier: NCT00740883.",2020,"The HERDOO2, DASH and Updated Vienna scores displayed c-statistics of 0.61 (95%CI 0.54-0.68), 0.60 (95%CI 0.53-0.66) and 0.58 (95%CI 0.51-0.66) respectively.",['371 unprovoked pulmonary embolism patients initially treated during 6 months'],"['PVOI', 'warfarin or placebo']",['Venous Thromboembolism Recurrence Scores'],"[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",371.0,0.625721,"The HERDOO2, DASH and Updated Vienna scores displayed c-statistics of 0.61 (95%CI 0.54-0.68), 0.60 (95%CI 0.53-0.66) and 0.58 (95%CI 0.51-0.66) respectively.","[{'ForeName': 'Leela', 'Initials': 'L', 'LastName': 'Raj', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Presles', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Le Mao', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Robin', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sanchez', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pernod', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Département de Médecine Vasculaire, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bertoletti', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jego', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Interne, Centre Hospitalo-Universitaire de Rennes, Université de Rennes 1, France.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Lemarié', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Leven', 'Affiliation': 'Service de Cardiologie and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': ""Service d'Echo-doppler Vasculaire, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Planquette', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Le Roux', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Slaun', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Nonent', 'Affiliation': 'Service de Radiologie, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Département Thoracique, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Lacut', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Solen', 'Initials': 'S', 'LastName': 'Mélac', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Guégan', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mismetti', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France.'}, {'ForeName': 'Silvy', 'Initials': 'S', 'LastName': 'Laporte', 'Affiliation': 'Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'F-CRIN INNOVTE, Saint Etienne, France; Université Paris Descartes, Université Sorbonne Paris Cité, France; Service de Pneumologie et de Soins intensifs, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; INSERM UMR S 1140, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leroyer', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tromeur', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Couturaud', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France; F-CRIN INNOVTE, Saint Etienne, France. Electronic address: francis.couturaud@chu-brest.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.03.040']
88,32335900,"The impact of respiratory protective equipment on difficult airway management: a randomised, crossover, simulation study.","The current international COVID-19 health crisis underlines the importance of adequate and suitable personal protective equipment for clinical staff during acute airway management. This study compares the impacts of standard air-purifying respirators and powered air-purifying respirators during simulated difficult airway scenarios. Twenty-five anaesthetists carried out four different standardised difficult intubation drills, either unprotected (control), or wearing a standard or a powered respirator. Treatment times and wearer comfort were determined and compared. In the wearer comfort evaluation form, operators rated mobility, noise, heat, vision and speech intelligibility. All anaesthetists accomplished the treatment objectives of all study arms without adverse events. Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™; 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope; 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope; and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard tracheal intubation by direct laryngoscopy, respectively. Videolaryngoscopy allowed the shortest intubation times regardless of the respiratory protective device used. Anaesthetists rated heat and vision significantly higher in the powered respirator group; however, noise levels were perceived to be significantly lower than in the standard respirator group. We conclude that standard and powered respirators do not significantly prolong simulated advanced intubation procedures.",2020,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.",[],"['standard air purifying respirators and powered air purifying respirators', 'respiratory protective equipment', 'standardised difficult intubation drills, either unprotected (control), or wearing a standard, or a powered respirator', 'Videolaryngoscopy']","['Total mean (SD) intubation times', 'Anaesthetists rated heat and vision', 'operators rated mobility, noise, heat, vision, and speech intelligibility', 'Treatment times and wearer comfort', 'noise levels']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035208', 'cui_str': 'Air-purifying respirator'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0549401', 'cui_str': 'Difficult intubation'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.0444717,"Total mean (SD) intubation times for the four interventions did not show significant differences between the powered and the standard respirator groups, being 16.4 (8.6) vs. 19.2 (5.2) seconds with the Airtraq™, 11.4 (3.4) vs. 10.0 (2.1) seconds with the videolaryngoscope, 39.2 (4.5) vs. 40.1 (4.8) seconds with the fibreoptic bronchoscope scope, and 15.4 (5.7) vs. 15.1 (5.0) seconds for standard endotracheal intubation by direct laryngoscopy, respectively.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schumacher', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Arlidge', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dudley', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sicinski', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Department of Anaesthesia, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Anaesthesia,['10.1111/anae.15102']
89,32335963,Effects of active commuting on cardiovascular risk factors: GISMO-a randomized controlled feasibility study.,"A sedentary lifestyle is a major modifiable risk factor for many chronic diseases. Lifestyle modification in order to increase exercise capacity is key in the prevention and rehabilitation of chronic diseases. This could be achieved by active commute. The aim of this study was to assess the effects of daily active commuting on physical activity (PA) and exercise capacity. Seventy-three healthy hospital employees (age: 46 ± 9 years, 38% male), with a predominantly passive way of commuting, were randomly assigned to two parallel groups, a control group (CG, N = 22) or an intervention group (IG, N = 51), which was further split into public transportation/active commuting (IG-PT, N = 25) and cycling (IG-C, N = 26). Both intervention groups were asked to reach 150 min/wk of moderate- to vigorous-intensity exercise during their commute for 1 year. CG maintained a passive commuting mode. All participants underwent assessment of anthropometry, risk factor stratification, and exercise capacity by a medical doctor at the Institute of Sports Medicine, Prevention and Rehabilitation. Weekly physical activity, using the International Physical Activity Questionnaire and commuting behavior, using an online diary, were used to assess physical activity. At the end of the study, the change in exercise capacity did significantly differ between IG and CG (P = .003, ES = 0.82). Actively covered distances through commuting significantly differed between groups (walking P = .026; cycling P < .001). Therefore, active commuting improves exercise capacity and can be recommended to the working population to increase exercise capacity.",2020,Actively covered distances through commuting significantly differed between groups (walking p=0.026; cycling p<0.001).,"['73 healthy hospital employees (age: 46±9 years, 38% males), with a predominantly passive way of commuting', 'All participants underwent assessment of anthropometry, risk factor stratification and exercise capacity by a medical doctor at the Institute of preventive and rehabilitative Sports Medicine']","['moderate-vigorous intensity exercise', 'active commuting', 'control group (CG, N=22) or an intervention group (IG, N=51) which was further split into public transportation/active commuting (IG-PT']","['cardiovascular risk factors', 'change in exercise capacity', 'physical activity (PA) and exercise capacity']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",73.0,0.0486887,Actively covered distances through commuting significantly differed between groups (walking p=0.026; cycling p<0.001).,"[{'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reich', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Loidl', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Fernandez La Puente de Battre', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Valentina Alice', 'Initials': 'VA', 'LastName': 'Rossi', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Zagel', 'Affiliation': 'Department of Geoinformatics, Paris Lodron University Salzburg, Salzburg, Austria.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Caselli', 'Affiliation': 'Cardiovascular Center Zürich, Hirslanden Klinik im Park, Zürich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmied', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, University of Zurich, Zürich, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': 'Institute of Sports Medicine, Prevention and Rehabilitation and Research Institute of Molecular Sports Medicine and Rehabilitation, Paracelsus Medical University, Salzburg, Austria.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13697']
90,32282591,Uterine Exteriorization Compared With In Situ Repair of Hysterotomy After Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


To compare the effect of exteriorized with in situ uterine repair on intraoperative nausea and vomiting during elective cesarean delivery under spinal anesthesia using a phenylephrine infusion.
METHODS


This study was a randomized double-blinded controlled trial of 180 women undergoing elective cesarean delivery using a standardized anesthetic protocol. Patients were randomized to exteriorization (n=90) or in situ uterine repair (n=90). The spinal anesthetic, phenylephrine infusion, and blood pressure management were all standardized. The primary outcome was postdelivery intraoperative nausea and vomiting using a 4-point scale (0-3). A sample size of 80 patients per group was needed to demonstrate a 50% reduction in intraoperative nausea and vomiting with in situ repair.
RESULTS


From November 2015 through July 2018, 180 patients were enrolled. Incidence of postdelivery intraoperative nausea and vomiting was 39% in the exteriorization group compared with 22% in the in situ group (P=.01). Incidence of hypotension (80% vs 50%; P<.001) and tachycardia (33% vs 17%; P=.02) was significantly higher in the exteriorization group, and more phenylephrine boluses were administered to this group (median 4 boluses [first and third quartiles 1.25-7] vs 2 [0-4]; P<.001). The duration of surgery, blood loss, and postoperative hemoglobin decline were similar between groups.
CONCLUSION


In situ uterine repair for elective cesarean delivery under spinal anesthesia with a phenylephrine infusion is associated with less postdelivery intraoperative nausea and vomiting.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02587013.",2020,"Incidence of hypotension (80% vs 50%; P<.001) and tachycardia (33% vs 17%; P=.02) was significantly higher in the exteriorization group, and more phenylephrine boluses were administered to this group (median 4 boluses [first and third quartiles 1.25-7] vs 2 [0-4]; P<.001).","['From November 2015 through July 2018, 180 patients were enrolled', '180 women undergoing elective cesarean delivery using a standardized anesthetic protocol']","['phenylephrine infusion', 'phenylephrine', 'exteriorized with in situ uterine repair', 'Uterine Exteriorization Compared With In Situ Repair of Hysterotomy', 'exteriorization (n=90) or in situ uterine repair']","['postdelivery intraoperative nausea and vomiting using a 4-point scale (0-3', 'duration of surgery, blood loss, and postoperative hemoglobin decline', 'Incidence of postdelivery intraoperative nausea and vomiting', 'tachycardia', 'postdelivery intraoperative nausea and vomiting', 'Incidence of hypotension', 'intraoperative nausea and vomiting']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0475403', 'cui_str': 'Exteriorized'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0195379', 'cui_str': 'Repair of uterus'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0185000', 'cui_str': 'Exteriorization - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0020711', 'cui_str': 'Incision of uterus'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",180.0,0.709089,"Incidence of hypotension (80% vs 50%; P<.001) and tachycardia (33% vs 17%; P=.02) was significantly higher in the exteriorization group, and more phenylephrine boluses were administered to this group (median 4 boluses [first and third quartiles 1.25-7] vs 2 [0-4]; P<.001).","[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Mireault', 'Affiliation': ""Department of Anesthesiology, Sainte-Justine Hospital, University of Montréal, and the Departments of Anesthesiology and Pain Medicine and Obstetrics and Gynecology, Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montréal, Québec, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loubert', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Drolet', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Tordjman', 'Affiliation': ''}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Godin', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Richebé', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Zaphiratos', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003821']
91,32282603,Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether removal of a double-balloon device for cervical ripening for 6 compared with 12 hours in women with an unfavorable cervix will result in a shorter time to delivery, similar cervical ripening, and without affecting cesarean delivery rate.
METHODS


In a prospective randomized trial, cervical ripening was performed using a double-balloon device. Women were randomized to removal of the device after 6 compared with 12 hours. Primary outcome was time to delivery. Secondary outcomes included mode of delivery, Bishop score, and maternal and neonatal adverse outcomes. A sample size of 100 nulliparous and 100 parous women was required assuming a 95% CI, power of 80%, and mean decrease of 6 hours to delivery between the groups.
RESULTS


From March 2017 through February 2019, 688 women were screened, 243 were found eligible, and 197 were randomized as follows: nulliparous cohort (n=101): removal after 6 hours (n=48) compared with removal after 12 hours (n=53); parous cohort (n=96): removal after 6 hours (n=49) compared with removal after 12 hours (n=47). Insertion-to-delivery interval was significantly shorter in the 6-hour group for both nulliparous (25.6±12.8 hours vs 31.4±15.2 hours, P<.04; mean difference 5.8, 95% CI 0.2-11.3), and parous cohorts (18.0±6.8 hours vs 22.6±8.2 hours, P=.003; mean difference 4.7, 95% CI 1.6-7.7). Bishop score change and cesarean delivery rate were similar between groups regardless of parity. The 12-hour group in the combined cohort was associated with higher rates of maternal intrapartum fever (2% vs 10%, P=.02; odds ratio 5.3, 95% CI 1.1-24.8).
CONCLUSION


Insertion-to-delivery interval is shorter after 6 compared with 12 hours for both nulliparous and parous women. Cervical ripening with a double-balloon device may be achieved in 6 hours. The longer time was associated with a higher rate of intrapartum fever. Six hours should be considered as standard placement time for double-balloon catheters.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03045939.",2020,"CONCLUSION


Insertion-to-delivery interval is shorter after 6 compared with 12 hours for both nulliparous and parous women.","['688 women were screened, 243 were found eligible, and 197 were randomized as follows: nulliparous cohort (n=101): removal after 6 hours (n=48) compared with removal after 12 hours (n=53); parous cohort (n=96): removal after 6 hours (n=49) compared with removal after 12 hours (n=47', '100 nulliparous and 100 parous women', 'women with an unfavorable cervix', 'From March 2017 through February 2019', 'nulliparous and parous women']",['Double-Balloon Device'],"['Bishop score change and cesarean delivery rate', 'rate of intrapartum fever', 'higher rates of maternal intrapartum fever', 'Insertion-to-delivery interval', 'mode of delivery, Bishop score, and maternal and neonatal adverse outcomes', 'time to delivery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",688.0,0.790781,"CONCLUSION


Insertion-to-delivery interval is shorter after 6 compared with 12 hours for both nulliparous and parous women.","[{'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Bleicher', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, and the Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Dikopoltsev', 'Affiliation': ''}, {'ForeName': 'Einav', 'Initials': 'E', 'LastName': 'Kadour-Ferro', 'Affiliation': ''}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Sammour', 'Affiliation': ''}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Gonen', 'Affiliation': ''}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Sagi', 'Affiliation': ''}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Eshel', 'Affiliation': ''}, {'ForeName': 'Liraz', 'Initials': 'L', 'LastName': 'Nussam', 'Affiliation': ''}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Vitner', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003804']
92,32282608,Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial.,"OBJECTIVE


To investigate the effect of intraoperative balloon occlusion of the internal iliac arteries in women with placenta previa and antenatally diagnosed placenta accreta.
METHODS


In this single-center, randomized controlled trial, women with placenta previa and antenatally suspected placenta accreta were randomly assigned to either the balloon occlusion group or to the control group. The perioperative management approach was similar for both groups, other than preoperative balloon catheter placement and intraoperative occlusion of bilateral internal iliac arteries. The primary outcome was the number of packed red blood cell (RBC) units transfused. With a two-sided α of 0.05 and a power of 0.8, a sample size of 48 women per group was calculated to detect a mean reduction of 2 units packed RBCs transfused with an expected SD of 3.5.
RESULTS


From August 2017 to July 2018, we randomized 50 eligible women to the balloon group and 50 to the control group. Demographic, obstetric, and placental imaging characteristics were similar between groups. The number of packed RBC units transfused was not significantly different between groups (5.3±5.3 in the occlusion group vs 4.7±5.4 in the control group, P=.54). Hospitalization costs and incidence of postoperative fever were significantly higher in the balloon group. No significant differences were found in other outcomes.
CONCLUSION


Intraoperative balloon occlusion of the internal iliac arteries did not reduce the number of packed RBC units transfused in women with placenta previa and antenatally suspected placenta accreta.
CLINICAL TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-IOR-17012244.",2020,"The number of packed RBC units transfused was not significantly different between groups (5.3±5.3 in the occlusion group vs 4.7±5.4 in the control group, P=.54).","['From August 2017 to July 2018, we randomized 50 eligible women to the balloon group and 50 to the control group', 'Placenta Previa and Suspected Placenta Accreta', 'women with placenta previa and antenatally suspected placenta accreta', 'women with placenta previa and antenatally diagnosed placenta accreta']","['intraoperative balloon occlusion', 'balloon occlusion', 'Internal Iliac Artery Balloon Occlusion']","['Demographic, obstetric, and placental imaging characteristics', 'number of packed red blood cell (RBC) units transfused', 'number of packed RBC units transfused', 'Hospitalization costs and incidence of postoperative fever']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0032044', 'cui_str': 'Placenta accreta'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever'}]",50.0,0.269494,"The number of packed RBC units transfused was not significantly different between groups (5.3±5.3 in the occlusion group vs 4.7±5.4 in the control group, P=.54).","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Departments of Obstetrics and Gynecology, Ultrasound, Radiology, and Pathology and the Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, West China Second University Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xinghui', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003792']
93,31222771,"Effect of hyperinsulinaemia and insulin resistance on endocrine, metabolic and fertility outcomes in women with polycystic ovary syndrome undergoing ovulation induction.","OBJECTIVE


The aim of this study was to evaluate the effects of hyperinsulinaemia and insulin resistance (IR) on reproductive and metabolic disorders and fertility in women with polycystic ovary syndrome (PCOS).
DESIGN, SETTING, PARTICIPANTS AND MEASUREMENTS


This was a multicenter, randomized controlled trial involving a total of 1000 women diagnosed with PCOS according to the modified Rotterdam criteria at 21 sites (27 hospitals). We evaluated the effects of serum insulin levels and HOMA-IR on parameters and outcomes. The main outcome measures were anthropometric, biometric and ultrasound parameters at baseline and the clinical outcomes of ovulation, conception, pregnancy, live birth and pregnancy loss.
RESULTS


The relevant analysis between hyperinsulinaemia and IR and clinical characteristics showed that weight, waist and hip circumference, BMI, waist-to-hip ratio, acanthosis nigricans score and menstrual period were significantly correlated with fasting insulin (FIN) and HOMA-IR. There was no significant correlation between the hirsutism score or acne score with FIN or HOMA-IR. The relevant analysis between hyperinsulinaemia and IR and circulating sex steroids and gonadotrophins showed that FAI was significantly correlated with FIN and HOMA-IR (r = 0.240, P < 0.001 and r = 0.191, P < 0.001, respectively). Free testosterone was significantly correlated with FIN after adjusting for the influence of age. LH and LH/FSH were not related to FIN or HOMA-IR after statistical correction for differences in BMI. The relevant analysis between hyperinsulinaemia and IR and metabolic profile showed that FIN and HOMA-IR were positively associated with fasting glucose, cholesterol, triglycerides, low-density lipoprotein, Apo B, and the incidence of metabolic syndrome and were negatively associated with high-density lipoprotein. The predictive analysis between hyperinsulinaemia and IR with fertility showed that the levels of FIN and HOMA-IR were related to the fertility outcome (ovulation, pregnancy, conception or live birth) in patients with PCOS. After adjustments for age, total testosterone and free testosterone, increasing serum insulin levels and HOMA-IR were significantly associated with decreased cycle ovulation, conception, pregnancy and live birth rates.
CONCLUSIONS


Hyperinsulinaemia and IR are associated with reproductive and metabolic disorders and can predict the fertility outcomes in PCOS patients.",2019,"After adjustments for age, total testosterone and free testosterone, increasing serum insulin levels and HOMA-IR were significantly associated with decreased cycle ovulation, conception, pregnancy and live birth rates.
","['women with polycystic ovary syndrome (PCOS', 'women with polycystic ovary syndrome undergoing ovulation induction', 'PCOS patients', 'patients with PCOS', '1000 women diagnosed with PCOS according to the modified Rotterdam criteria at 21 sites (27 hospitals']","['hyperinsulinaemia and insulin resistance (IR', 'hyperinsulinaemia and insulin resistance']","['FIN and HOMA-IR', 'fertility outcomes', 'LH and LH/FSH', 'fasting insulin (FIN) and HOMA-IR', 'Free testosterone', 'cycle ovulation, conception, pregnancy and live birth rates', 'FIN or HOMA-IR', 'anthropometric, biometric and ultrasound parameters at baseline and the clinical outcomes of ovulation, conception, pregnancy, live birth and pregnancy loss', 'weight, waist and hip circumference, BMI, waist-to-hip ratio, acanthosis nigricans score and menstrual period', 'fasting glucose, cholesterol, triglycerides, low-density lipoprotein, Apo B, and the incidence of metabolic syndrome', 'fertility outcome (ovulation, pregnancy, conception or live birth', 'levels of FIN and HOMA-IR', 'endocrine, metabolic and fertility outcomes', 'hirsutism score or acne score with FIN or HOMA-IR', 'total testosterone and free testosterone, increasing serum insulin levels and HOMA-IR']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0029967', 'cui_str': 'Ovulation Induction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]","[{'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C0221270', 'cui_str': 'Acanthosis (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0578772', 'cui_str': 'Hirsutism score (observable entity)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}]",1000.0,0.0492765,"After adjustments for age, total testosterone and free testosterone, increasing serum insulin levels and HOMA-IR were significantly associated with decreased cycle ovulation, conception, pregnancy and live birth rates.
","[{'ForeName': 'Duojia', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Xinming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}]",Clinical endocrinology,['10.1111/cen.14050']
94,30381997,"Repetitive Transcranial Magnetic Stimulation with Resting-State Network Targeting for Treatment-Resistant Depression in Traumatic Brain Injury: A Randomized, Controlled, Double-Blinded Pilot Study.","Repetitive transcranial magnetic stimulation (rTMS) has demonstrated antidepressant efficacy but has limited evidence in depression associated with traumatic brain injury (TBI). Here, we investigate the use of rTMS targeted with individualized resting-state network mapping (RSNM) of dorsal attention network (DAN) and default mode network (DMN) in subjects with treatment-resistant depression associated with concussive or moderate TBI. The planned sample size was 50 with first interim analysis planned at 20, but only 15 were enrolled before the study was terminated for logistical reasons. Subjects were randomized to 20 sessions of bilateral rTMS (4000 left-sided excitatory pulses, 1000 right-sided inhibitory pulses) or sham. Treatment was targeted to the dorsolateral prefrontal cluster with maximal difference between DAN and DMN correlations based on resting-state functional magnetic resonance imaging with individualized RSNM. Mean improvement in the primary outcome, Montgomery-Asberg Depression Rating Scale (MADRS), was 56% ± 14% (n = 9) with active treatment and 27% ± 25% (n = 5) with sham (Cohen's d = 1.43). One subject randomized to sham withdrew before starting treatment. There were no seizures or other significant adverse events. MADRS improvement was inversely correlated with functional connectivity between the right-sided stimulation site and the subgenual anterior cingulate cortex (sgACC; r = -0.68, 95% confidence interval 0.03-0.925). Active treatment led to increased sgACC-DMN connectivity (d = 1.55) and increased sgACC anti-correlation with the left- and right-sided stimulation sites (d = -1.26 and -0.69, respectively). This pilot study provides evidence that RSNM-targeted rTMS is feasible in TBI patients with depression. Given the dearth of existing evidence-based treatments for depression in this patient population, these preliminarily encouraging results indicate that larger controlled trials are warranted.",2019,MADRS improvement was inversely correlated with functional connectivity between the right-sided stimulation site and the subgenual anterior cingulate cortex (sgACC;,"['Traumatic Brain Injury', 'subjects with treatment-resistant depression associated with concussive or moderate TBI', 'TBI patients with depression']","['Repetitive Transcranial Magnetic Stimulation with Resting-State Network Targeting', 'rTMS targeted with individualized resting-state network mapping (RSNM) of dorsal attention network (DAN) and default mode network (DMN', 'bilateral rTMS (4000 left-sided excitatory pulses, 1000 right-sided inhibitory pulses) or sham', 'Repetitive transcranial magnetic stimulation (rTMS', 'RSNM-targeted rTMS']","['subgenual anterior cingulate cortex (sgACC', 'functional connectivity', 'sgACC anti-correlation', 'sgACC-DMN connectivity', 'Montgomery-Asberg Depression Rating Scale (MADRS']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0443246', 'cui_str': 'Left sided (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",,0.323875,MADRS improvement was inversely correlated with functional connectivity between the right-sided stimulation site and the subgenual anterior cingulate cortex (sgACC;,"[{'ForeName': 'Shan H', 'Initials': 'SH', 'LastName': 'Siddiqi', 'Affiliation': '1 Department of Neurology, McLean Hospital, Belmont, Massachusetts.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Trapp', 'Affiliation': '6 Department of Psychiatry, University of Iowa Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Carl D', 'Initials': 'CD', 'LastName': 'Hacker', 'Affiliation': '4 Department of Neurosurgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Timothy O', 'Initials': 'TO', 'LastName': 'Laumann', 'Affiliation': '3 Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Kandala', 'Affiliation': '3 Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': '5 Department of Neurology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Trillo', 'Affiliation': '3 Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Pashtun', 'Initials': 'P', 'LastName': 'Shahim', 'Affiliation': '2 Center for Neuroscience and Regenerative Medicine, National Institutes of Health/Uniformed Services University of Health Sciences Traumatic Brain Injury Research Group, Bethesda, Maryland.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Leuthardt', 'Affiliation': '4 Department of Neurosurgery, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Alexandre R', 'Initials': 'AR', 'LastName': 'Carter', 'Affiliation': '5 Department of Neurology, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Brody', 'Affiliation': '2 Center for Neuroscience and Regenerative Medicine, National Institutes of Health/Uniformed Services University of Health Sciences Traumatic Brain Injury Research Group, Bethesda, Maryland.'}]",Journal of neurotrauma,['10.1089/neu.2018.5889']
95,32018030,Understanding the asthmatic response to an experimental rhinovirus infection: Exploring the effects of blocking IgE.,"BACKGROUND


Rhinovirus frequently causes asthma exacerbations among children and young adults who are allergic. The interaction between allergen and rhinovirus-induced symptoms and inflammation over time is unclear.
OBJECTIVE


Our aim was to compare the response to an experimental inoculation with rhinovirus-16 in allergic asthmatics with the response in healthy controls and to evaluate the effects of administrating omalizumab before and during the infection.
METHODS


Two clinical trials were run in parallel. In one of these trials, the response to an experimental inoculation with rhinovirus-16 among asthmatics with high levels of total IgE was compared to the response in healthy controls. The other trial compared the effects of administering omalizumab versus placebo to asthmatics in a randomized, double-blind placebo-controlled investigation. The primary outcome for both trials compared lower respiratory tract symptoms (LRTSs) between study groups over the first 4 days of infection.
RESULTS


Frequent comparisons of symptoms, lung function, and blood eosinophil counts revealed differences that were more pronounced among allergic asthmatics than among controls by days 2 and 3 after virus inoculation. Additionally, an augmentation of upper respiratory tract symptom scores and LRTS scores occurred among the atopic asthmatics versus the controls during the resolution of symptoms (P < .01 for upper respiratory symptom tract scores and P < .001 for LRTS scores). The beneficial effects of administering omalizumab on reducing LRTSs and improving lung function were strongest over the first 4 days.
CONCLUSIONS


LRTSs and blood eosinophil counts were augmented and lung function was reduced among allergic asthmatics early after rhinovirus inoculation but increased late in the infection during symptom resolution. The effect of administering omalizumab on the response to rhinovirus was most pronounced during the early/innate phase of the infection.",2020,Lower respiratory tract symptoms and blood eosinophil counts were augmented and lung function reduced among allergic asthmatics early after RV inoculation and increased late in the infection during symptom resolution.,"['Experimental Rhinovirus Infection', 'children and young adults who are allergic', 'allergic asthmatics and healthy controls']","['omalizumab', 'placebo', 'Blocking IgE']","['Lower respiratory tract symptoms and blood eosinophil counts', 'augmentation of upper and LRTS scores', 'symptoms, lung function and blood eosinophil counts', 'LRTS and improving lung function', 'lower respiratory tract symptoms (LRTS']","[{'cui': 'C0276447', 'cui_str': 'Disease due to Rhinovirus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.100517,Lower respiratory tract symptoms and blood eosinophil counts were augmented and lung function reduced among allergic asthmatics early after RV inoculation and increased late in the infection during symptom resolution.,"[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Heymann', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va; Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va. Electronic address: pwh5a@virginia.edu.'}, {'ForeName': 'Thomas A E', 'Initials': 'TAE', 'LastName': 'Platts-Mills', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Woodfolk', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Borish', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Murphy', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va; Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Holliday T', 'Initials': 'HT', 'LastName': 'Carper', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va; Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Conaway', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Steinke', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Muehling', 'Affiliation': 'Asthma and Allergic Diseases Center, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Gerald Teague', 'Affiliation': 'Division of Pediatric Respiratory Medicine, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Kennedy', 'Affiliation': 'Division of Allergy and Immunology, University of Arkansas for Medical Sciences, Little Rock, Ark.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Irani', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Virginia Commonwealth University, Richmond, Va.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'McGraw', 'Affiliation': 'Division of Pediatric Pulmonology, University of Rochester, Rochester, NY.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Early', 'Affiliation': 'Division of Pediatric Otolaryngology, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wheatley', 'Affiliation': 'Allergy, Asthma and Airways Biology Branch, Division of Allergy, Immunology, and Transplantation/National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Amy P', 'Initials': 'AP', 'LastName': 'Adams', 'Affiliation': 'Department of Pharmacy, University of Virginia, Charlottsville, Va.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Turner', 'Affiliation': 'Department of Pediatric Infectious Diseases, University of Virginia, Charlottsville, Va.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.01.035']
96,32318288,Risk Factors Associated with Cardiac Autonomic Modulation in Obese Individuals.,"Obesity leads to an imbalance in the autonomic nervous system, especially in increased sympathetic modulation and decreased vagal tone, and some anthropometric, metabolic, and lifestyle variables may increase the risk of developing cardiovascular disease.  Objective . To analyze the association between cardiovascular autonomic modulation and biochemical and anthropometric markers, food intake, and physical activity level in severely obese individuals.  Methodology . The present study is a cutout of a randomized clinical trial ""Effect of nutritional intervention and olive oil in severe obesity"" (DieTBra Trial), where the baseline data were analyzed. Anthropometric data, biochemical exams, heart rate variability (HRV), accelerometry, and 24 h recall (R24H) of obese patients (body mass index BMI ≥35 kg/m 2 ) were collected.  Results . 64 obese patients were analyzed, with a mean age of 39.10 ± 7.74 years (27 to 58 years). By HRV analysis, in the frequency domain, the obese had a higher predominance of sympathetic autonomic modulation (low frequency (LF) 56.44 ± 20.31 nu) and lower parasympathetic modulation (high frequency (HF) 42.52 ± 19.18 nu). A negative association was observed between the variables Homeostasis Evaluation Model (HOMA-IR) and HF ( p  = 0.049). In the physical activity analysis, there was a negative association between moderate to vigorous physical activity and the sympathetic component ( p  = 0.043), and for sedentary time (ST), there was a negative association with HF ( p  = 0.049) and LF/HF ( p  = 0.036) and a positive association with LF ( p  = 0.014). For multiple linear regression, waist circumference (WC) and HOMA-IR values were negatively associated with HF ( β  = -0.685,  p  = 0.010;  β  = -14.989,  p  = 0.010; respectively). HOMA-IR ( β  = 0.141,  p  = 0.003) and the percentage of lipids ingested ( β  = -0.030,  p  = 0.043) were negatively associated with LF/HF.  Conclusion . Among the cardiovascular risk variables studied, insulin resistance and central adiposity showed the greatest influence on cardiac autonomic modulation of obese, increasing the risk for cardiovascular disease.",2020,"HOMA-IR ( β  = 0.141,  p  = 0.003) and the percentage of lipids ingested ( β  = -0.030,  p  = 0.043) were negatively associated with LF/HF.  ","['severely obese individuals', 'Obese Individuals', '64 obese patients were analyzed, with a mean age of 39.10\u2009±\u20097.74 years (27 to 58 years']",['nutritional intervention and olive oil'],"['vigorous physical activity and the sympathetic component', 'parasympathetic modulation', 'sympathetic autonomic modulation', 'insulin resistance and central adiposity', 'sedentary time (ST', 'HOMA-IR', 'percentage of lipids ingested', 'waist circumference (WC) and HOMA-IR values', 'Anthropometric data, biochemical exams, heart rate variability (HRV), accelerometry, and 24\u2009h recall (R24H', 'variables Homeostasis Evaluation Model (HOMA-IR) and HF', 'cardiovascular autonomic modulation and biochemical and anthropometric markers, food intake, and physical activity level']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C4551560', 'cui_str': 'Central obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0503632,"HOMA-IR ( β  = 0.141,  p  = 0.003) and the percentage of lipids ingested ( β  = -0.030,  p  = 0.043) were negatively associated with LF/HF.  ","[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Oliveira', 'Affiliation': 'Medicine Faculty, Health Science Post-Graduation Program, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Medicine Faculty, Coordinator of the Severe Obesity Study Group, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Rosa', 'Affiliation': 'Medicine Faculty, Health Science Post-Graduation Program, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Annelisa', 'Initials': 'A', 'LastName': 'Santos', 'Affiliation': 'Medicine Faculty, Health Science Post-Graduation Program, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Rodrigues', 'Affiliation': 'Medicine Faculty, Health Science Post-Graduation Program, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Mendonça', 'Affiliation': 'Medicine Faculty, Health Science Post-Graduation Program, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Silva', 'Affiliation': 'Medicine Faculty, Health Science Post-Graduation Program, Universidade Federal de Goiás, Goiânia, Goiás, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goiás, Goiânia, Brazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Rebelo', 'Affiliation': 'Department of Morphology, Biological Sciences Institute, Federal University of Goiás, Goiânia, Goiás, Brazil.'}]",Journal of obesity,['10.1155/2020/7185249']
97,31805422,Variations in stepped-wedge cluster randomized trial design: Insights from the Patient-Centered Care Transitions in Heart Failure trial.,"The stepped-wedge (SW) cluster randomized controlled trial, in which clusters cross over in a randomized sequence from control to intervention, is ideal for the implementation and testing of complex health service interventions. In certain cases however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required. We examine the logistical and statistical implications of variations in SW design using the optimization of the Patient-Centered Care Transitions in Heart Failure trial for illustration. We review the following complete SW design variations: a typical SW design; an SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested substudies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed 3 incomplete SW design variations in which data are collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to accommodate cluster readiness. Variations in SW design offer pragmatic solutions to logistical challenges but have implications to statistical power. Advantages and disadvantages of each variation should be considered before finalizing the design of an SW randomized controlled trial.",2020,We examine the logistical and statistical implications of variations in SW design using the optimization of the Patient-Centered Care Transitions in Heart Failure trial for illustration.,[],[],[],[],[],[],3.0,0.0977757,We examine the logistical and statistical implications of variations in SW design using the optimization of the Patient-Centered Care Transitions in Heart Failure trial for illustration.,"[{'ForeName': 'Rudy R', 'Initials': 'RR', 'LastName': 'Unni', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shun Fu', 'Initials': 'SF', 'LastName': 'Lee', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Harriette Gc', 'Initials': 'HG', 'LastName': 'Van Spall', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Electronic address: harriette.vanspall@phri.ca.'}]",American heart journal,['10.1016/j.ahj.2019.08.017']
98,31911261,Cardiac Sarcoidosis multi-center randomized controlled trial (CHASM CS- RCT).,"Approximately 5% of patients with sarcoidosis have clinically manifest cardiac involvement. Clinical features of Cardiac Sarcoidosis are dependent on the location, extent, and activity of the disease. First line therapy is usually with prednisone and this is recommended based on clinician experience, expert opinion and small observational cohorts. There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions. Corticosteroid are associated with multiple adverse effects including hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections. In contrast Methotrexate is generally well tolerated and is increasingly used in other forms of sarcoidosis.
OBJECTIVES


The Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS-RCT; NCT03593759) is a multicenter randomized controlled trial designed to evaluate the optimal initial treatment strategy for patients with active cardiac sarcoidosis. We hypothesize that (1) a low dose prednisone/methotrexate combination will have non-inferior efficacy to standard dose prednisone and that (2) the low dose prednisone/ methotrexate combination will result in significantly better quality of life than standard dose prednisone, as a result of reduced burden of side effects.
METHODS/DESIGN


Eligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction. Subjects will be randomized in a 1:1 ratio to prednisone 0.5 mg/kg/day for 6 months (maximum dose 30 mg daily) OR to prednisone 20 mg daily for 1 month, then 10 mg daily for 1 month, then 5 mg daily for one month then stop AND methotrexate 15-20 mg once weekly for 6 months. The primary endpoint is summed perfusion rest score on 6-month PET (blinded core-lab review). The summed perfusion rest score is measure of myocardial fibrosis/scar. The design is non-inferiority with a sample size of 97 per group.
DISCUSSION


Given the multiorgan system potential adverse side effects of prednisone, proving noninferiority of an alternate regimen would be sufficient to make the alternative compare favorably to standard dose steroids. This is the first ever clinical trial in cardiac sarcoidosis and thus in addition to the listed goals of the trial, we will also establish a multi-center, multinational cardiac sarcoidosis clinical trials network. Such a collaborative infrastructure will enable a new era of high quality data to guide physicians when treating cardiac sarcoidosis patients.",2020,There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions.,"['Eligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction', 'patients with active cardiac sarcoidosis']","['Corticosteroid', 'prednisone/methotrexate', 'prednisone', 'Methotrexate']","['hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections', 'quality of life', 'summed perfusion rest score on 6-month PET (blinded core-lab review']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C0392077', 'cui_str': 'Cardiac sarcoidosis (disorder)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0428908', 'cui_str': 'Sinus Node Disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia (disorder)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0242707', 'cui_str': 'Right Ventricular Dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0034380'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.150713,There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Birnie', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada. Electronic address: dbirnie@ottawaheart.ca.'}, {'ForeName': 'Rob S B', 'Initials': 'RSB', 'LastName': 'Beanlands', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Nery', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'Aaron', 'Affiliation': 'University of Ottawa, ON, Canada.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'DeKemp', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Lorne', 'Initials': 'L', 'LastName': 'Gula', 'Affiliation': 'London Health Sciences Centre, On, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jeffery S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Hamilton Health Sciences Center, ON, Canada.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Judson', 'Affiliation': 'Albany Medical College, Albany, New York, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Juneau', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Department of Radiology and Nuclear Medicine, Montréal, QC, Canada.""}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan; Libin Cardiovascular Institute of Alberta, Alberta, Canada.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Quinn', 'Affiliation': 'Montreal Heart Institute, Quebec, Canada.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Rivard', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Toma', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Varnava', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'University of Ottawa Heart Institute, ON, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wickremasinghe', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Kron', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, USA.'}]",American heart journal,['10.1016/j.ahj.2019.10.003']
99,32149469,Effects of ipragliflozin on the development and progression of kidney disease in patients with type 2 diabetes: An analysis from a multicenter prospective intervention study.,"AIMS/INTRODUCTION


Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available.
METHODS


This was an investigator-initiated multicenter prospective intervention study in which ipragliflozin (50 mg) was administered once daily, and glycemic control, estimated glomerular filtration rate (eGFR) and adverse events were evaluated until 104 weeks after starting research.
RESULTS


There were 407 patients analyzed. In the eGFR ≥90 group and eGFR ≥60 to <90 group, eGFR had significantly decreased compared with baseline at all time points from 4 to 104 weeks. There were significant increases in the eGFR ≥45 to <60 groups compared with baseline at 36 weeks (2.3 ± 1.0) and 52 weeks (2.6 ± 1.2). Comparison between the eGFR <60, urine albumin-to-creatinine ratio >300 group and the eGFR <60, urine albumin-to-creatinine ratio <300 group showed a greater reduction in eGFR in the former (-5.4 ± 2.4 vs 3.3 ± 1.1) at 12 weeks and was maintained to 104 weeks. In any group, eGFR did not significantly decrease until 104 weeks compared with 4 weeks. The urine albumin-to-creatinine ratio after 52 weeks and after 104 weeks was significantly decreased compared with baseline in the eGFR ≥90 group.
CONCLUSIONS


Ipragliflozin lowers eGFR and corrects hyperfiltration in patients with high eGFR (eGFR ≥60). In patients with low eGFR (eGFR ≥30 to <60), ipragliflozin has the possibility of increasing eGFR and exerting a renoprotective effect.",2020,"In the estimated glomerular filtration rate (eGFR) ≥ 90 group and eGFR ≥60 < 90 group, eGFR had significantly decreased compared to baseline at all time points from 4 weeks to 104 weeks.","['patients with type 2 diabetes', 'cases with high eGFR (eGFR ≥60']","['ipragliflozin', 'Ipragliflozin']","['adverse events', 'eGFR', 'UACR', 'glomerular filtration rate (eGFR', 'glomerular filtration rate (eGFR) and', 'development and progression of kidney disease', 'Urine Albumin-to-Creatinine Ratio (UACR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0376979,"In the estimated glomerular filtration rate (eGFR) ≥ 90 group and eGFR ≥60 < 90 group, eGFR had significantly decreased compared to baseline at all time points from 4 weeks to 104 weeks.","[{'ForeName': 'Ikuro', 'Initials': 'I', 'LastName': 'Matsuba', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Kawata', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Iemitsu', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Asakura', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Amemiya', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Syogo', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Kaneshiro', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kanamori', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kubota', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shinoda', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Takai', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Takuma', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takihata', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takeda', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Machimura', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Fuyuki', 'Initials': 'F', 'LastName': 'Minagawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Minami', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Mokubo', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Miyakawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13248']
100,31240513,A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia.,"Purpose Cancer therapy-associated paronychia (CAP) is a frequent adverse event associated with cytotoxic and targeted therapies that may impact dosing of anticancer therapies and patient quality of life (QoL). There are currently no evidence-based management strategies or approved treatments for CAP. Materials and Methods This was a prospective, multicenter, randomized, double-blind, vehicle-controlled phase 2 study that evaluated the efficacy and safety of 6 to 8 weeks of 1% or 2% povidone-iodine (PVP-I) topical solution versus vehicle-control in adult patients with CAP. Patients were randomized to one of three treatment arms administered twice daily: 1% PVP-I (Cohort A), 2% PVP-I (Cohort B), or vehicle-control (Cohort C). The primary endpoint was a two-grade reduction (or reduction to grade 0 if involved nails were grade 1) on the six-point Paronychia Severity Grading (PSG) scale. Secondary endpoints included safety and the effect on QoL and microbiota. Results A total of 102 patients with cancer were randomized to the study. In Cohort A, 83 of 205 (40.5%, P = 0.6059) affected nails met the primary endpoint versus Cohort C. In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3. Conclusions Treatment with twice-daily topical 2% PVP-I was safe and resulted in improvement in CAP compared with control. Clinicaltrials.gov identifier: NCT03207906. https://clinicaltrials.gov/ct2/show/NCT03207906.",2019,"In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3.","['Cancer therapy-associated Paronychia', 'adult patients with CAP', '102 patients with cancer']","['povidone-iodine (PVP-I) topical solution', 'PVP', 'novel topical povidone-iodine formulation']","['CAP', 'two-grade reduction (or reduction to grade 0', 'safety and the effect on QoL and microbiota', 'moderately or very painful nails', 'efficacy and safety', 'six-point Paronychia Severity Grading (PSG) scale']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0991555', 'cui_str': 'Topical Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}]",102.0,0.530968,"In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3.","[{'ForeName': 'Kara D', 'Initials': 'KD', 'LastName': 'Capriotti', 'Affiliation': 'Veloce BioPharma LLC, Fort Lauderdale, FL, USA. kcapriotti@velocebiopharma.com.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Anadkat', 'Affiliation': 'Department of Medicine, Division of Dermatology, Washington University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Ohio State University Dermatology, Columbus, OH, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kaffenberger', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'McLellan', 'Affiliation': 'Department of Medicine, Division of Dermatology, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Barone', 'Affiliation': 'Veloce BioPharma LLC, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Kukoyi', 'Affiliation': 'Department of Medicine, Dermatology Service, New York, NY, USA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Goldfarb', 'Affiliation': 'Department of Medicine, Dermatology Service, New York, NY, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lacouture', 'Affiliation': 'Department of Medicine, Dermatology Service, New York, NY, USA.'}]",Investigational new drugs,['10.1007/s10637-019-00825-0']
101,31425479,Absolute lymphocyte count as a prognostic biomarker for overall survival in patients with advanced melanoma treated with ipilimumab.,"Biomarkers are needed to estimate which patients benefit most from combination ipilimumab and nivolumab immunotherapy. Rigorous biomarker analyses from prior ipilimumab randomized studies without nivolumab are likely to inform which biomarker analyses should be prioritized when examining patients treated with the combination. For the first time, the current analyses investigate absolute lymphocyte count (ALC) in randomized, controlled trials of ipilimumab without nivolumab to assess whether ALC is prognostic or predictive of ipilimumab treatment benefit. Data included patients (n = 1136) treated in the two randomized, controlled phase III studies MDX010-20 and CA184-024. ALC was measured at pretreatment baseline and every 3 weeks for up to 12 weeks, before each dose of ipilimumab. Cox proportional hazards models were used to estimate and test associations between ALC measures and overall survival (OS). In both randomized studies, baseline ALC and ALC halfway through induction (at week 6) were associated with OS not only in ipilimumab-treated patients but also in patients treated with non-ipilimumab control treatments. ALC increased in patients receiving ipilimumab, but this degree of change was not predictive of ipilimumab treatment benefit. Using data from randomized, controlled studies, we were able to conclude for the first time that baseline ALC, ALC halfway through induction (week 6) and the degree of ALC change from baseline to week 6 are prognostic biomarkers in melanoma patients, and do not appear to be predictive of ipilimumab treatment benefit. This more comprehensive understanding of ALC as a biomarker from ipilimumab trials will inform subsequent biomarker investigations in ongoing ipilimumab combination studies such as ipilimumab in combination with nivolumab.",2020,"ALC increased in patients receiving ipilimumab, but this degree of change was not predictive of ipilimumab treatment benefit.","['Data included patients (n = 1136', 'patients with advanced melanoma treated with']",['ipilimumab'],"['Absolute lymphocyte count', 'overall survival (OS', 'ALC', 'overall survival']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1136.0,0.164951,"ALC increased in patients receiving ipilimumab, but this degree of change was not predictive of ipilimumab treatment benefit.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Chasalow', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kuk', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Panageas', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Cheng', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Jianda', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center.'}]",Melanoma research,['10.1097/CMR.0000000000000633']
102,32325490,"Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial.","Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. Patients (N = 207) were randomized 1:1 to D-RVd or RVd induction (4 cycles), ASCT, D-RVd or RVd consolidation (2 cycles), and lenalidomide or lenalidomide plus D maintenance (26 cycles). The primary end point, stringent complete response (sCR) rate by the end of post-ASCT consolidation, favored D-RVd vs RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval, 0.87-2.82; 1-sided P = .068) and met the prespecified 1-sided α of 0.10. With longer follow-up (median, 22.1 months), responses deepened; sCR rates improved for D-RVd vs RVd (62.6% vs 45.4%; P = .0177), as did minimal residual disease (MRD) negativity (10-5 threshold) rates in the intent-to-treat population (51.0% vs 20.4%; P < .0001). Four patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group progressed; respective 24-month progression-free survival rates were 95.8% and 89.8%. Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but grade 3/4 infection rates were similar. Median CD34+ cell yield was 8.2 × 106/kg for D-RVd and 9.4 × 106/kg for RVd, although plerixafor use was more common with D-RVd. Median times to neutrophil and platelet engraftment were comparable. Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT02874742.",2020,There was no difference in median times to neutrophil or platelet engraftment.,"['ASCT-eligible NDMM patients', 'patients with transplant-eligible NDMM', 'Patients (N=207', 'Transplant-eligible Newly Diagnosed Multiple Myeloma', 'transplant-eligible patients with newly diagnosed multiple myeloma (NDMM']","['RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance', 'Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT', 'Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone', 'plerixafor']","['median times to neutrophil or platelet engraftment', 'stringent complete response (sCR) rate', 'Median CD34+ cell yield', 'depth of response', '24-month progression-free survival rates', 'Grade 3/4 hematologic adverse events', 'minimal residual disease negativity']","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",207.0,0.136648,There was no difference in median times to neutrophil or platelet engraftment.,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Laubach', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, School of Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology and Oncology, School of Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Silbermann', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Holstein', 'Affiliation': 'Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Costello', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Wildes', 'Affiliation': 'Section of Medical Oncology, Division of Oncology, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Shain', 'Affiliation': 'Department of Malignant Hematology, H. Lee Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cowan', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Lutska', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA; and.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hoehn', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Lin', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Blood,['10.1182/blood.2020005288']
103,32222912,"A Three-Part, Randomised Study to Investigate the Safety, Tolerability, Pharmacokinetics and Mode of Action of BC 007, Neutraliser of Pathogenic Autoantibodies Against G-Protein Coupled Receptors in Healthy, Young and Elderly Subjects.","BACKGROUND AND OBJECTIVE


BC 007 is a substance with a novel and innovative mode of action for the first-time causal treatment of chronic heart failure, associated with the occurrence of autoantibodies against the β1-adrenoceptor, and other diseases of mostly the heart and vascular system, being accompanied by the occurrence of functionally active agonistic autoantibodies against G-protein-coupled receptors ( f GPCR-AAb). The proposed mechanism of action of BC 007 is the neutralisation of these pathogenic autoantibodies which stimulate the respective receptor. To evaluate the safety, tolerability, pharmacokinetics and mode of action of BC 007, single intravenous infusions of increasing concentration were given to healthy young males and healthy elderly autoantibody-negative and autoantibody-positive participants of both sexes.
METHODS


This study was subdivided into three parts. Part A was a single-centre, randomised, double-blind, placebo-controlled safety and tolerability study including healthy young male autoantibody-negative Whites (N = 23) and Asians (N = 1), testing doses of 15, 50 and 150 mg BC 007 (Cohorts 1-3) and elderly male and female Whites (N = 8), testing a dose of 150 mg BC 007 (Cohort 4), randomly assigned in a 3:1 ratio to BC 007 or placebo. Open-label Part B included  f GPCR-AAb-positive subjects (50 and 150 mg BC 007, Cohorts 1 and 2, respectively). Open-label Part C included  f GPCR-AAb-positive subjects for testing doses of 300, 450, 750, 1350 mg and 1900 mg BC 007. Lower doses were either given as an infusion or divided into a bolus plus infusion up to a dose of 300 mg followed by a constant bolus of 150 mg up to a dose of 750 mg, while at doses of 1350 mg and 1900 mg it was a slow infusion with a constant infusion rate. Infusion times increased with increasing dose from 20 min (15, 50 or 150 mg) to 40 min (300, 450 or 750 mg), 75 min (1350 mg) and 105 min (1900 mg).
RESULTS


The mean observed BC 007 area under the concentration-time curve (AUC 0-24 ) increased with increasing dose in a dose proportional manner (slope estimate of 1.039). No serious adverse events were observed. Drug-related adverse events were predominantly the expected mild-to-moderate increase in bleeding time (aPTT), beginning with a dose of 50 mg, which paralleled the infusion and returned to normal shortly after infusion.  f GPCR-AAb neutralisation efficiency increased with increasing dose and was achieved for all subjects in the last cohort.
CONCLUSION


BC 007 is demonstrated to be safe and well tolerated. BC 007 neutralised  f GPCR-AAb, showing a trend for a dose-response relationship in elderly healthy but  f GPCR-AAb-positive subjects. CLINICALTRIALS.
GOV REGISTRATION NUMBER


NCT02955420.",2020,(AUC 0-24 ) increased with increasing dose in a dose proportional manner (slope estimate of 1.039).,"['elderly male and female Whites (N\u2009=\u20098), testing a dose of 150\xa0mg BC\xa0007', 'healthy young males and healthy elderly autoantibody-negative and autoantibody-positive participants of both sexes', 'Healthy, Young and Elderly Subjects', 'elderly healthy but  f GPCR-AAb-positive subjects', 'healthy young male autoantibody-negative Whites (N\u2009=\u200923) and Asians (N\u2009=\u20091), testing doses of 15, 50 and 150\xa0mg BC\xa0007']",['placebo'],"['safety, tolerability, pharmacokinetics', 'mean observed BC\xa0007 area under the concentration-time curve', 'f GPCR-AAb neutralisation efficiency', 'Safety, Tolerability, Pharmacokinetics', 'safe and well tolerated', 'serious adverse events', 'bleeding time (aPTT']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0854162', 'cui_str': 'Autoantibody negative'}, {'cui': 'C0853878', 'cui_str': 'Autoantibody positive'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005729', 'cui_str': 'Bleeding Time'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}]",,0.0423166,(AUC 0-24 ) increased with increasing dose in a dose proportional manner (slope estimate of 1.039).,"[{'ForeName': 'Niels-Peter', 'Initials': 'NP', 'LastName': 'Becker', 'Affiliation': 'Berlin Cures GmbH, Dept. Regulatory Affairs, Knesebeck Str. 59-61, 10719, Berlin, Germany.'}, {'ForeName': 'Annekathrin', 'Initials': 'A', 'LastName': 'Haberland', 'Affiliation': 'Berlin Cures GmbH, Dept. Regulatory Affairs, Robert-Rössle-Str. 10, 13125, Berlin, Germany. haberland@berlincures.de.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wenzel', 'Affiliation': 'Berlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Göttel', 'Affiliation': 'Berlin Cures GmbH, COO, Knesebeck Str. 59-61, 10719, Berlin, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Wallukat', 'Affiliation': 'Berlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Davideit', 'Affiliation': 'Berlin Cures GmbH, Dept. Quality Management, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schulze-Rothe', 'Affiliation': 'Berlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Hönicke', 'Affiliation': 'Berlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Ingolf', 'Initials': 'I', 'LastName': 'Schimke', 'Affiliation': 'Berlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bartel', 'Affiliation': 'Berlin Cures GmbH, Laboratory, Robert-Rössle-Str. 10, 13125, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sinn', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Iavarone', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Boergermann', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Kiley', 'Initials': 'K', 'LastName': 'Prilliman', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Müller', 'Affiliation': 'Berlin Cures GmbH, CEO, Knesebeck Str. 59-61, 10719, Berlin, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Berlin Cures GmbH, Clinical Operations, Knesebeck Str. 59-61, 10719, Berlin, Germany.'}]",Clinical drug investigation,['10.1007/s40261-020-00903-9']
104,32303203,"Social, economic and family factors associated with binge drinking in Spanish adolescents.","BACKGROUND


The main aim of this study was to determine the socioeconomic and family factors associated with binge drinking (BD) in Spanish adolescents who participated in a web-based computer intervention for the prevention of binge drinking known as Alerta Alcohol.
METHODS


Longitudinal analyses were carried out in a sample of Andalusian adolescents aged 15 to 19 enrolled in public schools, which was part of a two-arm cluster randomized controlled trial with an intervention group (IG) who received the Alerta Alcohol programme and a control group (CG) who did not receive any active intervention. Panel count data and the following econometric procedures were used: negative binomial, a two-part model and a finite mixture model. The endogenous variable in all models was the number of BD occasions in the last 30 days. A total of 1247 subjects in the pre-intervention period, with an average age of 16.8 years, plus 612 adolescents in the follow-up period (4 months later), were included in the analysis.
RESULTS


In relation to findings, being older (≥ 17 years old), having more pocket money and higher family alcohol consumption were associated with greater BD. By contrast, subjects who completed the questionnaire on Wednesday, Thursday or Friday, further from the previous weekend, indicated a lower number of BD occasions.
CONCLUSIONS


Our results suggest the need to include families, especially parents and siblings, in interventions aimed at preventing alcohol use among adolescents, given the association shown between BD and both family alcohol consumption and weekly pocket money or availability of money to adolescents. Given the findings with regard to age, future research aimed at intervening in early adolescence to prevent BD would be justified.
TRIAL REGISTRATION


(ClinicalTrials.gov): NCT03288896. Registration date: September 20, 2017. ""Retrospectively registered"".",2020,"Our results suggest the need to include families, especially parents and siblings, in interventions aimed at preventing alcohol use among adolescents, given the association shown between BD and both family alcohol consumption and weekly pocket money or availability of money to adolescents.","['Spanish adolescents', 'Spanish adolescents who participated in a web-based computer intervention for the prevention of binge drinking known as Alerta Alcohol', 'Longitudinal analyses were carried out in a sample of Andalusian adolescents aged 15 to 19 enrolled in public schools, which was part of a two-arm cluster randomized controlled trial with an', '1247 subjects in the pre-intervention period, with an average age of 16.8\u2009years, plus 612 adolescents in the follow-up period (4 months later), were included in the analysis']",['intervention group (IG) who received the Alerta Alcohol programme and a control group (CG) who did not receive any active intervention'],[],"[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4517591', 'cui_str': '16.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",[],1247.0,0.047646,"Our results suggest the need to include families, especially parents and siblings, in interventions aimed at preventing alcohol use among adolescents, given the association shown between BD and both family alcohol consumption and weekly pocket money or availability of money to adolescents.","[{'ForeName': 'Ana Magdalena', 'Initials': 'AM', 'LastName': 'Vargas-Martínez', 'Affiliation': 'Department of Nursing. Faculty of Nursing, Physiotherapy and Podiatry, Universidad de Sevilla, Seville, Spain. avargas5@us.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Faculty of Economics and Social Sciences, Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Mora', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lima-Serrano', 'Affiliation': 'Department of Nursing. Faculty of Nursing, Physiotherapy and Podiatry, Universidad de Sevilla, Seville, Spain.'}]",BMC public health,['10.1186/s12889-020-08605-9']
105,32333714,Long-term follow-up after radiotherapy for prostate cancer with and without rectal hydrogel spacer: a pooled prospective evaluation of bowel-associated quality of life.,"OBJECTIVE


To evaluate the long-term bowel-associated quality of life (QOL) in men after radiotherapy (RT) for prostate cancer with and without the use of rectal hydrogel spacer.
PATIENTS AND METHODS


The patients' QOL was examined using the Expanded Prostate Cancer Index Composite (EPIC) and mean changes from baseline in EPIC domains were evaluated. A total of 215 patients from a randomised multi-institutional trial of RT, with or without hydrogel spacer, with a QOL endpoint were pooled with 165 non-randomised patients from a single institution with prospective QOL collection in patients with or without hydrogel spacer. The proportions of men with minimally important differences (MIDs) relative to pre-treatment baseline in the bowel domain were tested using repeated measure logistic models with a pre-specified threshold for clinically significant declines (≥5 equivalent to MIDx1 and ≥10 equivalent to MIDx2).
RESULTS


A total of 380 men were evaluated (64% with spacer and 36% without) with QOL data being available for 199 men with >24 months of follow-up [median (range) 39.5 (31-71.4) months]. Treatment with spacer was associated with less decline in average long-term bowel QOL (89.4 for control and 94.7 for spacer) with differences at >24 months meeting the threshold of a MID difference between cohorts (bowel score difference from baseline: control = -5.1, spacer = 0.3, difference = -5.4; P < 0.001). When evaluated over time men without spacer were more likely to have MIDx1 (5 points) declines in bowel QOL (P = 0.01). At long-term follow-up MIDx1 was 36% without spacer vs 14% with spacer (P <0.001; odds ratio [OR] 3.5, 95% CI 1.7-6.9) while MIDx2 was seen in 19% vs 6% (P = 0.008; OR 3.6, 95% CI 1.4-9.1). The use of spacer was associated with less urgency with bowel movements (P = 0.002) and fewer loose stools (P = 0.009), as well as less bother with urgency (P = 0.007) and frequency of bowel movements (P = 0.009).
CONCLUSIONS


In this pooled analysis of QOL after prostate RT with up to 5 years of follow-up, use of a rectal spacer was associated with preservation of bowel QOL. This QOL benefit was preserved with long-term follow-up.",2020,"The use of spacer was associated with less urgency with bowel movements (p=0.002) and fewer loose stools (p=0.009) as well as less bother with urgency (0.007) and frequency of bowel movements (p=0.009).
","['A total of 380 men were evaluated (64% with\xa0spacer\xa0and 36% without) with QOL data being available for 199 men beyond 24 months of follow-up (median: 39.5 months, range: 31-71.4 mo', 'men receiving radiotherapy for prostate cancer', 'patients with\xa0or without hydrogel spacer', '215 patients']","['radiation with or without hydrogel spacer with a QOL end-point', 'Radiotherapy']","['loose stools', 'Expanded Prostate Cancer Index Composite (EPIC', 'MIDx2', 'frequency of bowel movements', 'bowel QOL', 'spacer', 'urgency with bowel movements', 'average long-term bowel QOL']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C4709308', 'cui_str': '215'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",380.0,0.0484881,"The use of spacer was associated with less urgency with bowel movements (p=0.002) and fewer loose stools (p=0.009) as well as less bother with urgency (0.007) and frequency of bowel movements (p=0.009).
","[{'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Seymour', 'Affiliation': 'Department of Radiation Oncology, Beaumont Health, Dearborn, MI, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Hamstra', 'Affiliation': 'Department of Radiation Oncology, Beaumont Health, Dearborn, MI, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Daignault-Newton', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Department of Radiation Oncology and School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology and School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Hiram A', 'Initials': 'HA', 'LastName': 'Gay', 'Affiliation': 'Department of Radiation Oncology and School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pinkawa', 'Affiliation': 'Department of Radiotherapy, RWTH Aachen University, Aachen, Germany.'}]",BJU international,['10.1111/bju.15097']
106,32146521,Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Limited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.
METHODS


This was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.
RESULTS


Success did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.
CONCLUSIONS


Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.",2020,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","['women with advanced prolapse versus stage II prolapse', 'women with advanced prolapse (stage III-IV) and stress urinary incontinence', 'women with advanced vaginal prolapse', 'women with advanced pelvic organ prolapse and stress urinary incontinence', 'women with advanced prolapse', 'Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse']","['ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care', 'uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF', 'native tissue transvaginal apical approaches']","['Serious adverse events', 'individual success components', 'Surgical success, symptom severity, and overall serious adverse events', 'Prolapse symptom severity scores', 'individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0205990', 'cui_str': 'Vaginal Prolapse'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",374.0,0.18451,"Surgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse.","[{'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA. imeyer@uabmc.edu.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Whitworth', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Department of Reproductive Medicine, University of California-San Diego Health Systems, San Diego, CA, USA.'}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'Department of Surgery, Division of Urology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Ackenbom', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Wai', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'The Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, 3040 E Cornwallis Rd, Research Triangle Park, NC, USA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, 35249, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-020-04271-y']
107,31277991,"Feasibility, Acceptability, and Process Indicators for Guy2Guy, an mHealth HIV Prevention Program for Sexual Minority Adolescent Boys.","PURPOSE


Guy2Guy is one of the first mHealth HIV prevention programs for sexual minority boys aged 14-18 years, evaluated nationally. Here, we examine the program's feasibility and acceptability and explore participants' feedback about program content and components intended to invigorate program engagement.
METHODS


Guy2Guy was tested in a randomized controlled trial of 302 youth assigned to either the intervention or an attention-matched control group. At 3-month follow-up, participants completed a survey that included questions about feasibility and acceptability. Focus groups were conducted with a subset of intervention participants (n = 45) to further understand their program experience.
RESULTS


The protocol and program appeared to be feasible: 94% completed the 3-month follow-up survey. The intervention also appeared to be acceptable: 93% of intervention participants said they somewhat or strongly agreed that they liked the program. Although ∼20% boys agreed that the program sent too many messages, only 10% said they stopped reading the messages by the end. Focus group participants were largely enthusiastic about program content and generally appreciated receiving information and skills-building messages that talked about HIV risk reduction. Some indicated a desire for more content that addressed condom negotiation. Program engagement components, particularly the weekly ""level up"" quiz, also were generally well received.
CONCLUSIONS


Sexual minority boys are willing to engage in Guy2Guy, an intensive, multiweek sexual health intervention via text messaging, and most would recommend the program to their friends.",2019,The intervention also appeared to be acceptable: 93% of intervention participants said they somewhat or strongly agreed that they liked the program.,"['Sexual Minority Adolescent Boys', 'sexual minority boys aged 14-18\xa0years, evaluated nationally', '302 youth assigned to either the']",['intervention or an attention-matched control group'],[],"[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],302.0,0.0217854,The intervention also appeared to be acceptable: 93% of intervention participants said they somewhat or strongly agreed that they liked the program.,"[{'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Center for Innovative Public Health Research, San Clemente, California. Electronic address: Michele@innovativePublicHealth.org.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Prescott', 'Affiliation': 'Center for Innovative Public Health Research, San Clemente, California.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing and Department of Medical Social Sciences, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Parsons', 'Affiliation': 'Department of Psychology, Hunter College, City University of New York, New York, New York.'}, {'ForeName': 'Sheana S', 'Initials': 'SS', 'LastName': 'Bull', 'Affiliation': 'Community and Behavioral Health, Colorado School of Public Health, Denver, Colorado.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.04.025']
108,32326827,Melatonin suppression during a simulated night shift in medium intensity light is increased by 10-minute breaks in dim light and decreased by 10-minute breaks in bright light.,"Exposure to light at night results in disruption of endogenous circadian rhythmicity and/or suppression of pineal melatonin, which can consequently lead to acute or chronic adverse health problems. In the present study, we investigated whether exposure to very dim light or very bright light for a short duration influences melatonin suppression, subjective sleepiness, and performance during exposure to constant moderately bright light. Twenty-four healthy male university students were divided into two experimental groups: Half of them (mean age: 20.0 ± 0.9 years) participated in an experiment for short-duration (10 min) light conditions of medium intensity light (430 lx, medium breaks) vs. very dim light (< 1 lx, dim breaks) and the other half (mean age: 21.3 ± 2.5 years) participated in an experiment for short-duration light conditions of medium intensity light (430 lx, medium breaks) vs. very bright light (4700 lx, bright breaks). Each simulated night shift consisting of 5 sets (each including 50-minute night work and 10-minute break) was performed from 01:00 to 06:00 h. The subjects were exposed to medium intensity light (550 lx) during the night work. Each 10-minute break was conducted every hour from 02:00 to 06:00 h. Salivary melatonin concentrations were measured, subjective sleepiness was assessed, the psychomotor vigilance task was performed at hourly intervals from 21:00 h until the end of the experiment. Compared to melatonin suppression between 04:00 and 06:00 h in the condition of medium breaks, the condition of dim breaks significantly promoted melatonin suppression and the condition of bright breaks significantly diminished melatonin suppression. However, there was no remarkable effect of either dim breaks or bright breaks on subjective sleepiness and performance of the psychomotor vigilance task. Our findings suggest that periodic exposure to light for short durations during exposure to a constant light environment affects the sensitivity of pineal melatonin to constant light depending on the difference between light intensities in the two light conditions (i.e., short light exposure vs. constant light exposure). Also, our findings indicate that exposure to light of various intensities at night could be a factor influencing the light-induced melatonin suppression in real night work settings.",2020,"However, there was no remarkable effect of either dim breaks or bright breaks on subjective sleepiness and performance of the psychomotor vigilance task.",['Twenty-four healthy male university students were divided into two experimental groups: Half of them (mean age: 20.0\xa0±\xa00.9\xa0years) participated in an'],"['experiment for short-duration (10\xa0min) light conditions of medium intensity light (430\xa0lx, medium breaks) vs. very dim light (< 1\xa0lx, dim breaks) and the other half (mean age: 21.3\xa0±\xa02.5\xa0years) participated in an experiment for short-duration light conditions of medium intensity light (430\xa0lx, medium breaks) vs. very bright light (4700\xa0lx, bright breaks']","['Salivary melatonin concentrations', 'subjective sleepiness and performance of the psychomotor vigilance task', 'subjective sleepiness', 'Melatonin suppression', 'psychomotor vigilance task']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",24.0,0.0191275,"However, there was no remarkable effect of either dim breaks or bright breaks on subjective sleepiness and performance of the psychomotor vigilance task.","[{'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Noguchi', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Ohashi', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'Department of Kansei Science, Graduate School of Integrated Frontier Science, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Kaho', 'Initials': 'K', 'LastName': 'Maeda', 'Affiliation': 'Ground Facilities Department, Japan Aerospace Exploration Agency , Tsukuba, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Motomura', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University , Fukuoka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Awata', 'Affiliation': 'Ground Facilities Department, Japan Aerospace Exploration Agency , Tsukuba, Japan.'}, {'ForeName': 'Shigekazu', 'Initials': 'S', 'LastName': 'Higuchi', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University , Fukuoka, Japan.'}]",Chronobiology international,['10.1080/07420528.2020.1752704']
109,32282015,Effect of an Enhanced Paramedic Acute Stroke Treatment Assessment on Thrombolysis Delivery During Emergency Stroke Care: A Cluster Randomized Clinical Trial.,"Importance


Rapid thrombolysis treatment for acute ischemic stroke reduces disability among patients who are carefully selected, but service delivery is challenging.
Objective


To determine whether an enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention increased hospital thrombolysis rates.
Design, Setting, and Participants


This multicenter, cluster randomized clinical trial took place between December 2015 and July 2018 in 3 ambulance services and 15 hospitals. Clusters were paramedics based within ambulance stations prerandomized to PASTA or standard care. Patients attended by study paramedics were enrolled after admission if a hospital specialist confirmed a stroke and paramedic assessment started within 4 hours of onset. Allocation to PASTA or standard care reflected the attending paramedic's randomization status.
Interventions


The PASTA intervention included additional prehospital information collection, a structured hospital handover, practical assistance up to 15 minutes after handover, a predeparture care checklist, and clinician feedback. Standard care reflected national guidelines.
Main Outcomes and Measures


Primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included time intervals and day 90 health (with poor status defined as a modified Rankin Score >2, to represent dependency or death).
Results


A total of 11 478 patients were screened following ambulance transportation; 1391 were eligible and approached, but 177 did not consent. Of 1214 patients enrolled (mean [SD] age, 74.7 [13.2] years; 590 women [48.6%]), 500 were assessed by 242 paramedics trained in the PASTA intervention and 714 were assessed by 355 paramedics continuing with standard care. The paramedics trained in the PASTA intervention took a mean of 13.4 (95% CI, 9.4-17.4) minutes longer (P < .001) to complete patient care episodes. There was less thrombolysis among the patients in the PASTA group, but this was not significant (PASTA group, 197 of 500 patients [39.4%] vs the standard care group, 319 of 714 patients [44.7%]; adjusted odds ratio, 0.81 [95% CI, 0.61-1.08]; P = .15). Time from a paramedic on scene to thrombolysis was a mean of 8.5 minutes longer in the PASTA group (98.1 [37.6] minutes) vs the standard care group (89.4 [31.1] minutes; P = .01). Poor health outcomes did not differ significantly but occurred less often among patients in the PASTA group (313 of 489 patients [64.0%]) vs the standard care group (461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI, 0.60-1.20]; P = .39).
Conclusions and Relevance


An enhanced paramedic assessment did not facilitate thrombolysis delivery. The unexpected combination of thrombolysis and health outcomes suggests possible alternative influences on treatment decisions by the intervention, requiring further evaluation.
Trial Registration


ISRCTN Registry Identifier: ISRCTN12418919.",2020,"Poor health outcomes did not differ significantly but occurred less often among patients in the PASTA group (313 of 489 patients [64.0%]) vs the standard care group (461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI, 0.60-1.20]; P = .39).
","['December 2015 and July 2018 in 3 ambulance services and 15 hospitals', '1214 patients enrolled (mean [SD] age, 74.7 [13.2] years; 590 women [48.6%]), 500 were assessed by 242 paramedics trained in the PASTA intervention and 714 were assessed by 355 paramedics continuing with standard care', 'A total of 11\u202f478 patients were screened following ambulance transportation; 1391 were eligible and approached, but 177 did not consent', 'Patients attended by study paramedics were enrolled after admission if a hospital specialist confirmed a stroke and paramedic assessment started within 4 hours of onset']",['enhanced Paramedic Acute Stroke Treatment Assessment (PASTA) intervention'],"['Poor health outcomes', 'proportion of patients receiving thrombolysis', 'Thrombolysis Delivery', 'hospital thrombolysis rates', 'time intervals and day 90 health (with poor status defined as a modified Rankin Score >2, to represent dependency or death']","[{'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",11478.0,0.0889342,"Poor health outcomes did not differ significantly but occurred less often among patients in the PASTA group (313 of 489 patients [64.0%]) vs the standard care group (461 of 690 patients [66.8%]; adjusted odds ratio, 0.86 [95% CI, 0.60-1.20]; P = .39).
","[{'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Saiful', 'Initials': 'S', 'LastName': 'Islam', 'Affiliation': 'Swansea University Medical School, Swansea, Wales, United Kingdom.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Javanbakht', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Swansea University Medical School, Swansea, Wales, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McMeekin', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Snooks', 'Affiliation': 'Swansea University Medical School, Swansea, Wales, United Kingdom.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Flynn', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lakey', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Sutcliffe', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'McClelland', 'Affiliation': 'North East Ambulance Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lally', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Exley', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': 'Stroke Research Group, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea, Wales, United Kingdom.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Medical Sciences Division, University of Oxford, Oxford, United Kingdom.'}]",JAMA neurology,['10.1001/jamaneurol.2020.0611']
110,32282034,"Effects of Telephone and Short Message Service Support on Infant Feeding Practices, ""Tummy Time,"" and Screen Time at 6 and 12 Months of Child Age: A 3-Group Randomized Clinical Trial.","Importance


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


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


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


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


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


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


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


http://anzctr.org.au Identifier: ACTRN12616001470482.",2020,"Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63","['at 6 and 12 Months of Child Age', '1155 mothers, 947 (82%; mean [SD] age, 32.5 [5.0] years) completed follow-up surveys at 6 months; 920 mothers (80%) completed follow-up surveys at 12 months', 'February 23, 2017, to November 30, 2018, among 1155 women in the third trimester of pregnancy in New South Wales, Australia']","['Telephone and Short Message Service Support', 'nurse-led telephone or SMS support', 'http://anzctr.org.au Identifier', 'SMS', 'nurse-led telephone support session or SMS intervention']","['Infant Feeding Practices, ""Tummy Time,"" and Screen Time', 'breastfeeding rates', 'infant feeding practices at both 6 and 12 months and tummy time', 'screen time and bottle use', 'screen time at 12 months']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0996758,"Compared with the control group, telephone support led to higher odds of appropriate timing of introducing solid foods (adjusted odds ratio [AOR], 1.68 [95% CI, 1.22-2.32]), cup use (AOR, 1.54 [95% CI, 1.12-2.13]), and early-start tummy time (AOR, 1.63","[{'ForeName': 'Li Ming', 'Initials': 'LM', 'LastName': 'Wen', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taki', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Buchanan', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bedford', 'Affiliation': 'Health Promotion, Population Health Research and Evaluation Hub, Sydney Local Health District, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Philayrath', 'Initials': 'P', 'LastName': 'Phongsavan', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Baur', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0215']
111,31855716,Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.,"For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age < 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1,200) are randomized 1:1 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic ""trial within a registry"" design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.",2020,"Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications.","['infants undergoing heart surgery with CPB', 'infants (age <\u202f1\u202fyear) undergoing heart surgery with CPB', 'children with heart disease', 'Participants (planned enrollment\u202f=\u202f1,200', 'infants undergoing heart surgery with cardiopulmonary bypass (CPB']","['methylprednisolone', 'placebo', 'CPB pump prime versus placebo', 'corticosteroids', 'perioperative steroids']","['several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications', 'safety and efficacy', 'global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1200.0,0.537948,"Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications.","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'H Scott', 'Initials': 'HS', 'LastName': 'Baldwin', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Bichel', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Butts', 'Affiliation': 'University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Reid C', 'Initials': 'RC', 'LastName': 'Chamberlain', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Ellis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Hickerson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Marshall L', 'Initials': 'ML', 'LastName': 'Jacobs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert Db', 'Initials': 'RD', 'LastName': 'Jaquiss', 'Affiliation': 'University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Prince J', 'Initials': 'PJ', 'LastName': 'Kannankeril', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Torok', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Turek', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2019.11.016']
112,31577692,Early Enteral Nutrition Is Associated With Improved Clinical Outcomes in Critically Ill Children: A Secondary Analysis of Nutrition Support in the Heart and Lung Failure-Pediatric Insulin Titration Trial.,"OBJECTIVES


The impact of early enteral nutrition on clinical outcomes in critically ill children has not been adequately described. We hypothesized that early enteral nutrition is associated with improved clinical outcomes in critically ill children.
DESIGN


Secondary analysis of the Heart and Lung Failure-Pediatric Insulin Titration randomized controlled trial.
SETTING


Thirty-five PICUs.
PATIENTS


Critically ill children with hyperglycemia requiring inotropic support and/or invasive mechanical ventilation who were enrolled for at least 48 hours with complete nutrition data.
INTERVENTIONS


Subjects received nutrition via guidelines that emphasized enteral nutrition and were classified into early enteral nutrition (enteral nutrition within 48 hr of study randomization) and no early enteral nutrition (enteral nutrition after 48 hr of study randomization, or no enteral nutrition at any time).
MEASUREMENTS AND MAIN RESULTS


Of 608 eligible subjects, 331 (54%) received early enteral nutrition. Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93). After controlling for age, body mass index z scores, primary reason for ICU admission, severity of illness, and mean Vasopressor-Inotrope Score at the time of randomization, and adjusting for site, early enteral nutrition was associated with lower 90-day hospital mortality (8% vs 17%; p = 0.007), more ICU-free days (median, 20 vs 17 d; p = 0.02), more hospital-free days (median, 8 vs 0 d; p = 0.003), more ventilator-free days (median, 21 vs 19 d; p = 0.003), and less organ dysfunction (median maximum Pediatric Logistic Organ Dysfunction, 11 vs 12; p < 0.001).
CONCLUSIONS


In critically ill children with hyperglycemia requiring inotropic support and/or mechanical ventilation, early enteral nutrition was independently associated with better clinical outcomes.",2020,"Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93).","['Critically Ill Children', 'critically ill children', 'Critically ill children with hyperglycemia requiring inotropic support and/or invasive mechanical ventilation who were enrolled for at least 48 hours with complete nutrition data', '608 eligible subjects, 331 (54%) received early enteral nutrition', 'critically ill children with hyperglycemia requiring inotropic support and/or mechanical ventilation, early enteral nutrition', 'Thirty-five PICUs']","['early enteral nutrition', 'nutrition via guidelines that emphasized enteral nutrition and were classified into early enteral nutrition (enteral nutrition within 48 hr of study randomization) and no early enteral nutrition (enteral nutrition after 48 hr of study randomization, or no enteral nutrition at any time']","['organ dysfunction', 'ICU admission, severity of illness, and mean Vasopressor-Inotrope Score', '90-day hospital mortality', 'daily caloric intake']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1046445', 'cui_str': 'Picus'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",608.0,0.27809,"Both early enteral nutrition and no early enteral nutrition groups had similar daily caloric intake over the first 8 study days (median, 36 vs 36 kcal/kg/d; p = 0.93).","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Hasbani', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Nilesh M', 'Initials': 'NM', 'LastName': 'Mehta', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Division of Critical Care, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Sharon Y', 'Initials': 'SY', 'LastName': 'Irving', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Kandil', 'Affiliation': 'Section of Pediatric Critical Care Medicine, Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'H Christine', 'Initials': 'HC', 'LastName': 'Allen', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Department of Pediatrics, The Children's Hospital of Oklahoma, Oklahoma City, OK.""}, {'ForeName': 'Katri V', 'Initials': 'KV', 'LastName': 'Typpo', 'Affiliation': ""Department of Pediatrics, Banner Children's at Diamond Children's Medical Center, Tucson, AZ.""}, {'ForeName': 'Natalie Z', 'Initials': 'NZ', 'LastName': 'Cvijanovich', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital, Oakland, CA.""}, {'ForeName': 'E Vincent S', 'Initials': 'EVS', 'LastName': 'Faustino', 'Affiliation': 'Section of Pediatric Critical Care Medicine, Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Michael S D', 'Initials': 'MSD', 'LastName': 'Agus', 'Affiliation': ""Division of Medical Critical Care, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002135']
113,32219386,Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes.,"Importance


Additional treatments are needed for heart failure with reduced ejection fraction (HFrEF). Sodium-glucose cotransporter 2 (SGLT2) inhibitors may be an effective treatment for patients with HFrEF, even those without diabetes.
Objective


To evaluate the effects of dapagliflozin in patients with HFrEF with and without diabetes.
Design, Setting, and Participants


Exploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries. Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019.
Interventions


Addition of once-daily 10 mg of dapagliflozin or placebo to recommended therapy.
Main Outcomes and Measures


The primary outcome was the composite of an episode of worsening heart failure or cardiovascular death. This outcome was analyzed by baseline diabetes status and, in patients without diabetes, by glycated hemoglobin level less than 5.7% vs greater than or equal to 5.7%.
Results


Among 4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial. Among participants without diabetes, the primary outcome occurred in 171 of 1298 (13.2%) in the dapagliflozin group and 231 of 1307 (17.7%) in the placebo group (hazard ratio, 0.73 [95% CI, 0.60-0.88]). In patients with diabetes, the primary outcome occurred in 215 of 1075 (20.0%) in the dapagliflozin group and 271 of 1064 (25.5%) in the placebo group (hazard ratio, 0.75 [95% CI, 0.63-0.90]) (P value for interaction = .80). Among patients without diabetes and a glycated hemoglobin level less than 5.7%, the primary outcome occurred in 53 of 438 patients (12.1%) in the dapagliflozin group and 71 of 419 (16.9%) in the placebo group (hazard ratio, 0.67 [95% CI, 0.47-0.96]). In patients with a glycated hemoglobin of at least 5.7%, the primary outcome occurred in 118 of 860 patients (13.7%) in the dapagliflozin group and 160 of 888 (18.0%) in the placebo group (hazard ratio, 0.74 [95% CI, 0.59-0.94]) (P value for interaction = .72). Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes. A kidney adverse event was reported in 4.8% of patients in the dapagliflozin group and 6.0% in the placebo group among patients without diabetes and in 8.5% of patients in the dapagliflozin group and 8.7% in the placebo group among patients with diabetes.
Conclusions and Relevance


In this exploratory analysis of a randomized trial of patients with HFrEF, dapagliflozin compared with placebo, when added to recommended therapy, significantly reduced the risk of worsening heart failure or cardiovascular death independently of diabetes status.
Trial Registration


ClinicalTrials.gov Identifier: NCT03036124.",2020,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"['than 5.7% vs greater than or equal to 5.7', 'Patients With Heart Failure', '4744 patients randomized (mean age, 66 years; 1109 [23%] women; 2605 [55%] without diabetes), 4742 completed the trial', 'patients with', 'Participants\n\n\nExploratory analysis of a phase 3 randomized trial conducted at 410 sites in 20 countries', 'patients with HFrEF with and without diabetes', 'patients with HFrEF, even those without diabetes', 'Patients with New York Heart Association classification II to IV with an ejection fraction less than or equal to 40% and elevated plasma N-terminal pro B-type natriuretic peptide were enrolled between February 15, 2017, and August 17, 2018, with final follow-up on June 6, 2019']","['HFrEF, dapagliflozin', 'Dapagliflozin', 'placebo', 'dapagliflozin or placebo', 'dapagliflozin', 'Sodium-glucose cotransporter 2 (SGLT2) inhibitors']","['glycated hemoglobin', 'adverse event', 'glycated hemoglobin level less', 'kidney adverse event', 'risk of worsening heart failure or cardiovascular death independently of diabetes status', 'composite of an episode of worsening heart failure or cardiovascular death', 'Volume depletion', 'glycated hemoglobin level', 'Worsening Heart Failure and Cardiovascular Death']","[{'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}]",4744.0,0.292236,Volume depletion was reported as an adverse event in 7.3% of patients in the dapagliflozin group and 6.1% in the placebo group among patients without diabetes and in 7.8% of patients in the dapagliflozin group and 7.8% in the placebo group among patients with diabetes.,"[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlávek', 'Affiliation': 'Second Department of Internal Medicine, Cardiovascular Medicine, General Teaching Hospital, First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Medicine, Saarland University Hospital, Homburg/Saar, Germany.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'Division of Cardiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Medanta, Gurgaon, Haryana, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Jaroslaw', 'Initials': 'J', 'LastName': 'Drozdz', 'Affiliation': 'Department Cardiology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Fifth Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Disease, Department of Cardiology, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Howlett', 'Affiliation': 'Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Institute of Medicine, Department of Molecular and Clinical Medicine/Cardiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Ontario, Canada.'}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc, Vietnam.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Tereshchenko', 'Affiliation': 'Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City.""}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Center for Heart Diseases, University Hospital, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Discovery and Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",JAMA,['10.1001/jama.2020.1906']
114,27900662,Randomized Controlled Trial of Hyalobarrier ®  Versus No Hyalobarrier ®  on the Ovulatory Status of Women with Periovarian Adhesions: A Pilot Study.,"INTRODUCTION


Periadnexal adhesions are known to contribute to subfertility. The restoration of the tubo-ovarian anatomy is one the key principles in reproductive surgery, and this involves adhesiolysis. However, adhesion formation/reformation is very common after periovarian adhesiolysis. It is not known if the application of Hyalobarrier ® , an anti-adhesion gel, around the adnexal region postsurgery influences ovulatory status. The study is a pilot randomized controlled trial (RCT) randomizing women into the application of Hyalobarrier ®  versus no Hyalobarrier ®  at the time of laparoscopy, where postsurgical ovulatory status and pregnancy rates were evaluated.
METHODS


This was a pilot RCT where women were recruited from the gynecological and subfertility clinic who were deemed to require an operative laparoscopy. If intraoperatively they were found to have periovarian adhesions, they were randomized into having adhesiolysis with and without usage of Hyalobarrier ® . Demographic details and intraoperative details including the severity, extent, and the ease of use of Hyalobarrier ®  were recorded. Prior to the surgery and postoperatively, the participants had their serum hormonal status (day 2 FSH, LH and day 21 progesterone) evaluated. Postoperatively, they underwent a follicular tracking cycle at 3 months.
RESULTS


Fifteen women were randomized into use of Hyalobarrier ®  (study group) and 15 into the no Hyalobarrier ®  group (control group) between December 2011 and January 2014. There was no difference in the patient characteristics in terms of age, BMI, the number of previous pregnancies, or the extent, site, and severity of adhesions between the two groups. There was no significant difference between the study versus control groups in terms of the hormonal profile (day 2 FSH and day 21 progesterone) before or after surgery. The 3-month postoperative day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups. Four women were pregnant in the study group (24%) and one in the control group (7%) cumulatively over 2 years.
CONCLUSION


The use of Hyalobarrier ®  post salpingo-ovariolysis did not influence follicular development as inferred from the results of the day 21 progesterone and folliculogram on day 10-12 3-month postsurgery.
TRIAL REGISTRATION


ISRCTN number, ISRCTN1833588.
FUNDING


Nordic Pharma.",2017,The 3-month postoperative day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups.,"['Fifteen women', 'group (control group) between December 2011 and January 2014', 'Four women were pregnant in the study group (24%) and one in the control group (7%) cumulatively over 2\xa0years', 'women were recruited from the gynecological and subfertility clinic who were deemed to require an operative laparoscopy', 'Women with Periovarian Adhesions']","['Hyalobarrier ®  Versus No Hyalobarrier ®', 'Hyalobarrier ®', 'Hyalobarrier ®  versus no Hyalobarrier ®', 'no Hyalobarrier ®']","['age, BMI, the number of previous pregnancies, or the extent, site, and severity of adhesions', 'serum hormonal status', 'postsurgical ovulatory status and pregnancy rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}]",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0422807', 'cui_str': 'Number of previous pregnancies (observable entity)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",15.0,0.0562662,The 3-month postoperative day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheong', 'Affiliation': 'Southampton University Hospital Foundation NHS Trust, Southampton, UK. y.cheong@soton.ac.uk.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bailey', 'Affiliation': 'Southampton University Hospital Foundation NHS Trust, Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'Southampton University Hospital Foundation NHS Trust, Southampton, UK.'}]",Advances in therapy,['10.1007/s12325-016-0453-z']
115,30401608,Effect of Vitamin D Supplementation on Depressive Symptoms in Patients With Knee Osteoarthritis.,"OBJECTIVES


To determine the effect of vitamin D supplementation and maintaining sufficient serum vitamin D on depressive symptoms in patients with knee osteoarthritis (OA) and vitamin D deficiency.
DESIGN


A prespecified secondary analysis of a multicentre, randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive oral vitamin D 3  (50,000 IU, n = 209) or placebo (n = 204) monthly for 24 months. In addition, participants who completed the trial were classified into 2 groups according to their serum 25(OH)D levels at month 3 and 24 as follows: not consistently sufficient (serum 25(OH)D ≤ 50 nmol/L at month 3 and/or 24), and consistently sufficient (serum 25(OH)D > 50 nmol/L at both month 3 and 24). Multilevel mixed-effect models were used to compare differences of change in PHQ-9 scores between groups.
SETTING AND PARTICIPANTS


This clinical trial was conducted in participants with symptomatic knee OA and vitamin D deficiency from June 2010 to December 2013 in Tasmania and Victoria, Australia.
MEASURES


The primary outcome was the depressive symptoms change over 24 months, which was measured using the Patient Health Questionnaire (PHQ-9, 0-27).
RESULTS


Of 599 participants who were screened for eligibility, 413 participants were enrolled (mean age: 63.2 years; 50.3% female) and 340 participants (intervention n = 181, placebo n = 159, 82.3% retention rate) completed the study. The baseline prevalence of depression (PHQ-9 score ≥5) was 25.4%. Depressive symptoms improved more in the vitamin D supplementation group compared to the placebo group [β: -0.66, 95% confidence interval (CI): -1.22 to -0.11, P for difference = .02] and in the participants who maintained vitamin D sufficiency compared to those who did not (β: -0.73, 95% CI: -1.41 to -0.05, P for difference = .04) over 24 months.
CONCLUSIONS/IMPLICATIONS


These findings suggest that vitamin D supplementation and maintaining adequate vitamin D levels over 24 months may be beneficial for depressive symptoms in patients with knee OA.",2019,"Depressive symptoms improved more in the vitamin D supplementation group compared to the placebo group [β: -0.66, 95% confidence interval (CI): -1.22 to -0.11, P for difference = .02] and in the participants who maintained vitamin D sufficiency compared to those who did not (β: -0.73, 95% CI: -1.41 to -0.05, P for difference = .04) over 24 months.
","['599 participants who were screened for eligibility, 413 participants were enrolled (mean age: 63.2\xa0years; 50.3% female) and 340 participants (intervention n\xa0=\xa0181, placebo n\xa0=\xa0159, 82.3% retention rate) completed the study', 'patients with knee osteoarthritis (OA) and vitamin D deficiency', 'patients with knee OA', 'Patients With Knee Osteoarthritis', 'participants with symptomatic knee OA and vitamin D deficiency from June 2010 to December 2013 in Tasmania and Victoria, Australia']","['vitamin D supplementation', 'placebo', 'Vitamin D Supplementation', 'vitamin D supplementation and maintaining sufficient serum vitamin D', 'oral vitamin D 3']","['baseline prevalence of depression (PHQ-9 score ≥5', 'depressive symptoms change', 'Depressive symptoms', 'depressive symptoms', 'Patient Health Questionnaire (PHQ-9, 0-27', 'PHQ-9 scores', 'Depressive Symptoms', 'serum 25(OH)D levels', 'adequate vitamin D levels']","[{'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",413.0,0.65408,"Depressive symptoms improved more in the vitamin D supplementation group compared to the placebo group [β: -0.66, 95% confidence interval (CI): -1.22 to -0.11, P for difference = .02] and in the participants who maintained vitamin D sufficiency compared to those who did not (β: -0.73, 95% CI: -1.41 to -0.05, P for difference = .04) over 24 months.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Liudan', 'Initials': 'L', 'LastName': 'Tu', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Cicuttini', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Weiyu', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Wluka', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Faculty of Health, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Meng', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Blizzard', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China. Electronic address: changhai.ding@utas.edu.au.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.09.006']
116,32325037,"Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial.","BACKGROUND


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


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


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


German Center for Infection Research.",2020,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","['Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2  and weight of more than 50 kg at screening, and a negative pregnancy test for women', 'six healthy adults, who did not receive any injections', 'healthy adults', 'All participants who were vaccinated at least once were included in the safety analysis', 'Middle East respiratory syndrome', 'University Medical Center Hamburg-Eppendorf (Hamburg, Germany', ' From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group', '2014-003195-23', '23 participants (12 in the low-dose group and 11 in the high-dose group']","['1\u2008×\u200810 7  plaque-forming unit (PFU; low-dose group) or 1\u2008×\u200810 8  PFU (high-dose group) MVA-MERS-S intramuscularly', 'MVA-MERS-S', 'modified vaccinia virus Ankara vector vaccine candidate', 'anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine']","['adverse events', 'fatigue or malaise', 'Safety and immunogenicity', 'MERS-CoV spike-specific T-cell responses', 'safety and tolerability', 'Immunogenicity', 'severe or serious adverse events', 'seroconversion using a MERS-CoV S1 ELISA', 'Headaches', 'adverse events: pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042216', 'cui_str': 'Vaccinia virus'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",6.0,0.132455,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dahlke', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Krähling', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Nisreen M A', 'Initials': 'NMA', 'LastName': 'Okba', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Asisa', 'Initials': 'A', 'LastName': 'Volz', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesterkamp', 'Affiliation': 'German Center for Infection Research, Hanover-Brunswick, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Borregaard', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'My L', 'Initials': 'ML', 'LastName': 'Ly', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Zinser', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bartels', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Joseph S H', 'Initials': 'JSH', 'LastName': 'Poetsch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Neumann', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fux', 'Affiliation': 'Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmiedel', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Haagmans', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Sutter', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'Addo', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany. Electronic address: m.addo@uke.de.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30248-6']
117,32286643,Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial.,"Importance


Chikungunya virus (CHIKV) is a mosquito-borne Alphavirus prevalent worldwide. There are currently no licensed vaccines or therapies.
Objective


To evaluate the safety and tolerability of an investigational CHIKV virus-like particle (VLP) vaccine in endemic regions.
Design, Setting, and Participants


This was a randomized, placebo-controlled, double-blind, phase 2 clinical trial to assess the vaccine VRC-CHKVLP059-00-VP (CHIKV VLP). The trial was conducted at 6 outpatient clinical research sites located in Haiti, Dominican Republic, Martinique, Guadeloupe, and Puerto Rico. A total of 400 healthy adults aged 18 through 60 years were enrolled after meeting eligibility criteria. The first study enrollment occurred on November 18, 2015; the final study visit, March 6, 2018.
Interventions


Participants were randomized 1:1 to receive 2 intramuscular injections 28 days apart (20 µg, n = 201) or placebo (n = 199) and were followed up for 72 weeks.
Main Outcomes and Measures


The primary outcome was the safety (laboratory parameters, adverse events, and CHIKV infection) and tolerability (local and systemic reactogenicity) of the vaccine, and the secondary outcome was immune response by neutralization assay 4 weeks after second vaccination.
Results


Of the 400 randomized participants (mean age, 35 years; 199 [50%] women), 393 (98%) completed the primary safety analysis. All injections were well tolerated. Of the 16 serious adverse events unrelated to the study drugs, 4 (25%) occurred among 4 patients in the vaccine group and 12 (75%) occurred among 11 patients in the placebo group. Of the 16 mild to moderate unsolicited adverse events that were potentially related to the drug, 12 (75%) occurred among 8 patients in the vaccine group and 4 (25%) occurred among 3 patients in the placebo group. All potentially related adverse events resolved without clinical sequelae. At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57). Eight weeks following the first administration, the EC50 GMT in the vaccine group was 2005 (95% CI, 1680-2392) vs 43 (95% CI, 32-58; P < .001) in the placebo group. Durability of the immune response was demonstrated through 72 weeks after vaccination.
Conclusions and Relevance


Among healthy adults in a chikungunya endemic population, a virus-like particle vaccine compared with placebo demonstrated safety and tolerability. Phase 3 trials are needed to assess clinical efficacy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02562482.",2020,"At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57).","['endemic regions', 'healthy adults in a chikungunya endemic population', '400 healthy adults aged 18 through 60 years were enrolled after meeting eligibility criteria', '400 randomized participants (mean age, 35 years; 199 [50%] women), 393 (98%) completed the primary safety analysis', '6 outpatient clinical research sites located in Haiti, Dominican Republic, Martinique, Guadeloupe, and Puerto Rico']","['Chikungunya Virus-Like Particle Vaccine', 'vaccine VRC-CHKVLP059-00-VP (CHIKV VLP', 'placebo', 'investigational CHIKV virus-like particle (VLP) vaccine']","['EC50 GMT', 'tolerated', 'safety and tolerability', 'safety (laboratory parameters, adverse events, and CHIKV infection) and tolerability (local and systemic reactogenicity', 'Safety and Tolerability Outcomes']","[{'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0013014', 'cui_str': 'Dominican Republic'}, {'cui': 'C0024853', 'cui_str': 'Martinique'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C0008056', 'cui_str': 'Chikungunya virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0333785', 'cui_str': 'Virus-like particles'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008055', 'cui_str': 'Chikungunya fever'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",400.0,0.684011,"At baseline, there was no significant difference between the effective concentration (EC50)-which is the dilution of sera that inhibits 50% infection in viral neutralization assay-geometric mean titers (GMTs) of neutralizing antibodies of the vaccine group (46; 95% CI, 34-63) and the placebo group (43; 95% CI, 32-57).","[{'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Coates', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Plummer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Cristina A', 'Initials': 'CA', 'LastName': 'Carter', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Berkowitz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Conan-Cibotti', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Josephine H', 'Initials': 'JH', 'LastName': 'Cox', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': ""O'Callahan"", 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ingelise J', 'Initials': 'IJ', 'LastName': 'Gordon', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Larkin', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lampley', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Kaltovich', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gall', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Carlton', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Mendy', 'Affiliation': 'Emergent BioSolutions, San Diego, California.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Haney', 'Affiliation': 'Emergent BioSolutions, San Diego, California.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'May', 'Affiliation': 'The Emmes Company, Rockville, Maryland.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Bray', 'Affiliation': 'The Emmes Company, Rockville, Maryland.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Bailer', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Dowd', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Brittanie', 'Initials': 'B', 'LastName': 'Brockett', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Koup', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Mascola', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Pierson', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Yeycy', 'Initials': 'Y', 'LastName': 'Donastorg', 'Affiliation': 'Instituto Dermatologico y Cirugia de Piel (IDCP), Dominican Republic.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rosario', 'Affiliation': 'San Juan Hospital, Puerto Rico.'}, {'ForeName': 'Jean William', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': ""The Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (Centres GHESKIO), Haiti.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Hoen', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1424, Centre Hospitalier Universitaire (CHU) de la Guadeloupe, France.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Cabié', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1424, Centre Hospitalier Universitaire (CHU) de Martinique, France.""}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'PR Clinical and Translational Research Consortium (PRCTRC), Puerto Rico.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Ledgerwood', 'Affiliation': 'Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.2477']
118,30969910,A Comparison of Word-Recognition Performances on the Auditec and VA Recorded Versions of Northwestern University Auditory Test No. 6 by Young Listeners with Normal Hearing and by Older Listeners with Sensorineural Hearing Loss Using a Randomized Presentation-Level Paradigm.,"BACKGROUND


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


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


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


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


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


Each of the 48 listeners had higher recognition performances on the Auditec version of NU-6 than on the VA version. The respective overall recognition performances on the Auditec and VA versions were 71.4% and 64.1% (YNH) and 68.7% and 58.2% (OHL). At the highest presentation levels, recognition performances on the two versions differed by only 0.5% (YNH) and 3.3% (OHL). At the 50% correct point, performances on the Auditec version were 3.2 dB (YNH) and 6.1 dB (OHL) better than those on the VA version. The slopes at the 50% points on the mean functions for both speakers were about 4.9%/dB (YNH) and 3.0%/dB (OHL); however, the slopes evaluated from the individual listener data were steeper, 5.2 to 5.3%/dB (YNH) and 3.3 to 3.5%/dB (OHL). When the individual data were transformed from dB SL to dB HL, the differences between the two listener groups were emphasized. The four functions (2 speakers by 2 listener groups) were plotted for each of the 48 participants and each of the 200 words, which revealed the gamut of relations among the datasets. Examination of the data for each speaker across test sessions, in the traditional 50-word lists, and in the typically used 25-word lists of Randomization A revealed no differences of clinical concern. Finally, introspective reports from the listeners revealed that 91.7% and 83.3% of the YNH and OHL listeners, respectively, thought the Auditec speaker was easier to understand than the VA speaker. Recognition performances on each participant and on each word are presented.",2019,Each of the 48 listeners had higher recognition performances on the Auditec version of NU-6 than on the VA version.,"['older listeners with sensorineural hearing loss (OHL', '48 listeners', 'SAMPLE\n\n\nTwelve YNH (M = 24.0 years; PTA = 9.9-dB HL) and 36 OHL listeners (M = 71.6 years; PTA = 26.7-dB HL', 'Young Listeners with Normal Hearing and by Older Listeners with Sensorineural Hearing Loss', 'young adults with normal hearing for pure tones (YNH']",[],['Auditec and VA versions'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],[],48.0,0.0181677,Each of the 48 listeners had higher recognition performances on the Auditec version of NU-6 than on the VA version.,"[{'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Wilson', 'Affiliation': 'Arizona State University, Tempe, AZ.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17135']
119,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


Nitric oxide (NO) plays an important role in normal postnatal transition. Our aims were to determine whether adding inhaled NO (iNO) decreases supplemental oxygen exposure in preterm infants requiring positive pressure ventilation (PPV) during resuscitation and to study iNO effects on heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation during the first 20 min of life.
METHODS


This was a pilot, double-blind, randomized, placebo-controlled trial. Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled. PPV was initiated with either oxygen (FiO 2 -0.30) + iNO at 20 ppm (iNO group) or oxygen (FiO 2 -0.30) + nitrogen (placebo group). Oxygen was titrated targeting defined SpO 2  per current guidelines. After 10 min, iNO/nitrogen was weaned stepwise per protocol and terminated at 17 min.
RESULTS


Twenty-eight infants were studied (14 per group). The mean gestational age in both groups was similar. Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group. There were no differences in HR, SpO 2 , and need for intubation.
CONCLUSIONS


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
120,32296094,Clinical Study on the Effectiveness of Three Products in the Treatment of Herpes Simplex Labialis.,"Herpes simplex labialis (HSL) is a viral disease that affects the perioral region. No guidelines recommending an effective treatment exist. The treatment of HSL with three different products was examined. Herpatch Serum, a film-forming patch, was compared to Compeed Patches, a set of semiocclusive hydrocolloid patches, and Zovirax Cream (ingredient: 5% acyclovir). In this prospective, randomized, examiner-blind study, 180 patients with recurrent HSL were split into three groups (Compeed: n = 60, Herpatch: n = 60, Zovirax: n = 60) and examined within 24 hours of HSL outbreak (DRKS Registration No.: DRKS00007786). The primary endpoint was healing time. The secondary endpoints were the reaction rate and quality of therapy evaluated by the Clinician's Global Assessment of Therapy (CGAT) and the Subject's Global Assessment of Therapy (SGAT) (0 = no response; 10 = excellent response), respectively. There was no significant difference among the healing times for the different products. The mean (95% confidence interval) was 9.67 days (9.11-10.22) for Compeed, 9.30 days (8.75-9.85) for Herpatch, and 9.80 days (9.30-10.30) for Zovirax. The reaction rate and quality of therapy (CGAT and SGAT) of Herpatch were significantly higher than those of Compeed and Zovirax. Within the study limitations, Herpatch proved to be an effective, non-antiviral alternative in the treatment of HSL.",2020,"Within the study limitations, Herpatch proved to be an effective, non-antiviral alternative in the treatment of HSL.","['Herpes simplex labialis (HSL', '180 patients with recurrent HSL', 'Herpes Simplex Labialis']","['Herpatch: n\u2009=\u200960, Zovirax: n\u2009=\u200960) and examined within 24\u2009hours of HSL outbreak (DRKS Registration No', 'Zovirax Cream (ingredient: 5% acyclovir']","['reaction rate and quality of therapy (CGAT and SGAT) of Herpatch', ""reaction rate and quality of therapy evaluated by the Clinician's Global Assessment of Therapy (CGAT) and the Subject's Global Assessment of Therapy (SGAT"", 'healing time', 'healing times']","[{'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0592290', 'cui_str': 'Zovirax'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",180.0,0.0268437,"Within the study limitations, Herpatch proved to be an effective, non-antiviral alternative in the treatment of HSL.","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Boes', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany. Hanna.Boes@uni-wh.de.'}, {'ForeName': 'Vlasios', 'Initials': 'V', 'LastName': 'Goulioumis', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wechsler', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Zimmer', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Bizhang', 'Affiliation': 'Department of Operative and Preventive Dentistry, Faculty of Health, Witten/Herdecke University, Witten, Germany.'}]",Scientific reports,['10.1038/s41598-020-63530-6']
121,31721596,Short halt in vaping modifies cardiorespiratory parameters and urine metabolome: a randomized trial.,"Propylene glycol and glycerol are e-cigarette constituents that facilitate liquid vaporization and nicotine transport. As these small hydrophilic molecules quickly cross the lung epithelium, we hypothesized that short-term cessation of vaping in regular users would completely clear aerosol deposit from the lungs and reverse vaping-induced cardiorespiratory toxicity. We aimed to assess the acute effects of vaping and their reversibility on biological/clinical cardiorespiratory parameters [serum/urine pneumoproteins, hemodynamic parameters, lung-function test and diffusing capacities, transcutaneous gas tensions (primary outcome), and skin microcirculatory blood flow]. Regular e-cigarette users were enrolled in this randomized, investigator-blinded, three-period crossover study. The periods consisted of nicotine-vaping (nicotine-session), nicotine-free vaping (nicotine-free-session), and complete cessation of vaping (stop-session), all maintained for 5 days before the session began. Multiparametric metabolomic analyses were used to verify subjects' protocol compliance. Biological/clinical cardiorespiratory parameters were assessed at the beginning of each session (baseline) and after acute vaping exposure. Compared with the nicotine- and nicotine-free-sessions, a specific metabolomic signature characterized the stop-session. Baseline serum club cell protein-16 was higher during the stop-session than the other sessions ( P  < 0.01), and heart rate was higher in the nicotine-session ( P  < 0.001). Compared with acute sham-vaping in the stop-session, acute nicotine-vaping (nicotine-session) and acute nicotine-free vaping (nicotine-free-session) slightly decreased skin oxygen tension ( P  < 0.05). In regular e-cigarette-users, short-term vaping cessation seemed to shift baseline urine metabolome and increased serum club cell protein-16 concentration, suggesting a decrease in lung inflammation. Additionally, acute vaping with and without nicotine decreased slightly transcutaneous oxygen tension, likely as a result of lung gas exchanges disturbances.",2020,Baseline serum club-cell protein-16 was higher during the stop-session than the other sessions ( p<0.01 ) and heart rate was higher in the nicotine-session ( p<0.001 ).,['Regular e-cigarette users'],"['acute nicotine-vaping (nicotine-session) and acute nicotine-free vaping (nicotine-free-session', 'nicotine-vaping (nicotine-session), nicotine-free vaping (nicotine-free-session), and complete cessation of vaping (stop-session', 'nicotine']","['slightly transcutaneous oxygen tension', 'biological/clinical cardio-respiratory parameters (serum/urine pneumoproteins, hemodynamic parameters, lung-function test and diffusing capacities, transcutaneous gas tensions (primary outcome) and skin microcirculatory blood flow', 'Baseline serum club-cell protein-16', 'skin oxygen tension ( p<0.05 ', 'heart rate', 'lung inflammation']","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial (procedure)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.0184367,Baseline serum club-cell protein-16 was higher during the stop-session than the other sessions ( p<0.01 ) and heart rate was higher in the nicotine-session ( p<0.001 ).,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chaumont', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Tagliatti', 'Affiliation': 'Department of Human Biology and Toxicology, University of Mons, Mons, Belgium.'}, {'ForeName': 'El Mehdi', 'Initials': 'EM', 'LastName': 'Channan', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Colet', 'Affiliation': 'Department of Human Biology and Toxicology, University of Mons, Mons, Belgium.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'Laboratory of Toxicology and Applied Pharmacology, Institute of Experimental and Clinical Research, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Morra', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Deprez', 'Affiliation': 'Department of Clinical Chemistry, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Van Muylem', 'Affiliation': 'Chest Department, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Debbas', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schaefer', 'Affiliation': 'Cardio-Pulmonary Exercise Laboratory, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Vitalie', 'Initials': 'V', 'LastName': 'Faoro', 'Affiliation': 'Cardio-Pulmonary Exercise Laboratory, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'van de Borne', 'Affiliation': 'Department of Cardiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.'}]",American journal of physiology. Lung cellular and molecular physiology,['10.1152/ajplung.00268.2019']
122,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


To evaluate if the bioadhesive polymer (Carbopol 980) could potentiate the protective effect of sodium fluoride with stannous chloride (FS) solution on the control of enamel erosive wear.
METHODS


Cylindrical bovine enamel specimens were polished and randomly allocated into three groups (n = 60): FS (500 ppm F -  +800 ppm Sn 2+  - positive control), FS + Carbopol (0.1% Carbopol), and ultrapure water (negative control). A randomized double-blind cross-over in situ model with three phases was used. In each phase, volunteers (n = 15) used a palatal appliance containing 4 specimens: two were submitted to an erosion model (2 h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5 min, 4x/day; 1 h intervals of saliva exposure; and treatment with the test solutions for 1 min, 2x/day). Besides erosion, the other two specimens were also subjected to abrasion (2x/day, 15 s) with active electric toothbrush, before the treatment with the solutions. After 5 days, enamel surface loss (μm) was evaluated by profilometry. Data were analyzed by two-way RM-ANOVA and Tukey tests (5%).
RESULTS


There were significant differences for both challenge and treatment factors. Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05). The surface loss values for the erosion/remineralization model were (means ± SL): C = 14.7 ± 5.8b; FS = 9.0 ± 7.5ab; FS + Carbopol = 5.9 ± 3.8a; and for erosion/abrasion: C = 26.6 ± 10.1c; FS = 15.0 ± 8.8b; FS + Carbopol = 12.3 ± 7.9ab.
CONCLUSION


The association of Carbopol to the FS solution significantly protected the enamel against erosive wear, but it was not significantly superior to FS only.
CLINICAL SIGNIFICANCE


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
123,32101272,"Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial.","Importance


The operative scenarios with the highest postoperative pancreatic fistula (POPF) risk represent situations in which fistula prevention and mitigation strategies have the strongest potential to affect surgical outcomes after pancreaticoduodenectomy. Evidence from studies providing risk stratification is lacking.
Objective


To investigate whether pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent, is the best reconstruction method for patients at high risk of POPF after pancreaticoduodenectomy.
Design, Setting, and Participants


A single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score, some of whom were randomized to undergo PG or PJ. All analyses were performed on an intention-to-treat basis.
Interventions


Intervention consisted of PJ or PG, both with externalized transanastomotic stent and octreotide omission.
Main Outcomes and Measures


The primary end point was POPF. The secondary end points were Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden.
Results


A total of 604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n = 36; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n = 36; 26 men and 10 women; median age, 63 years [interquartile range, 35-79]). There was no significant difference in the incidence of POPF between patients who underwent PG and patients who underwent PJ (18 [50.0%] vs 14 [38.9%]; P = .48), but for patients who developed a POPF, the mean (SD) average complication burden was lower for those who underwent PJ than for those who underwent PG (0.25 [0.13] vs 0.39 [0.17]; P = .04). The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
Conclusions and Relevance


Among patients at the highest risk for POPF, those who underwent PG or PJ experienced similar rates of POPF. However, PG was associated with an increased incidence of Clavien-Dindo grade 3 or higher morbidity and with an increased average complication burden for the patients who developed a POPF. For patients at high risk for pancreatic fistula, PJ with the use of externalized stent and octreotide omission should be considered the most appropriate technical strategy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03212196.",2020,"The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
","['Patients', 'With High-Risk Pancreatic Anastomosis', 'Participants\n\n\nA single-center, phase 3, randomized clinical trial was conducted at the Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy, from July 12, 2017, through March 15, 2019, among adults undergoing elective pancreaticoduodenectomy and considered at high risk for pancreatic fistula after intraoperative assessment of the fistula risk score', '604 patients were screened for eligibility; 82 were at high risk for POPF (fistula risk score, 7-10), and 72 were randomized undergo PG (n\u2009=\u200936; 20 men and 16 women; median age, 65 years [interquartile range, 23-82]) or PJ (n\u2009=\u200936; 26 men and 10 women; median age, 63 years [interquartile range, 35-79', 'patients at high risk of POPF after pancreaticoduodenectomy']","['Externalized Stent vs Pancreaticogastrostomy With Externalized Stent', 'PJ or PG, both with externalized transanastomotic stent and octreotide omission', 'PG or PJ', 'pancreaticojejunostomy (PJ) or pancreaticogastrostomy (PG), both with externalized transanastomotic stent', 'externalized stent and octreotide omission']","['delayed gastric emptying', 'Clavien-Dindo grade 3 or higher morbidity, postpancreatectomy hemorrhage, delayed gastric emptying, and average complication burden', 'incidence of Clavien-Dindo grade 3 or higher morbidity', 'mean (SD) average complication burden', 'rates of postpancreatectomy hemorrhage', 'rates of POPF', 'POPF', 'incidence of POPF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis (procedure)'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0030303', 'cui_str': 'Pancreatojejunostomy'}]","[{'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",604.0,0.257267,"The rates of postpancreatectomy hemorrhage (14 [38.9%] in the PG group vs 9 [25.0%] in the PJ group; P = .31) and delayed gastric emptying (16 [44.4%] in the PG group vs 18 [50.0%] in the PJ group; P = .81) were similar, but patients who underwent PG presented with a significantly higher incidence of Clavien-Dindo grade 3 or higher morbidity than those who underwent PJ (17 [47.2%] vs 8 [22.2%]; P = .047).
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Andrianello', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Marchegiani', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Malleo', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Masini', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Balduzzi', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Paiella', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Esposito', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Landoni', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Casetti', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tuveri', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'The Pancreas Institute, Department of General and Pancreatic Surgery, University of Verona Hospital Trust, Verona, Italy.'}]",JAMA surgery,['10.1001/jamasurg.2019.6035']
124,32126156,Effect of cognitive behavioural therapy on sleep and opioid medication use in adults with fibromyalgia and insomnia.,"Sleep and opioid medications used to treat insomnia and chronic pain are associated with adverse side effects (falls and cognitive disturbance). Although behavioural treatments such as cognitive behavioral therapy for insomnia (CBT-I) and pain (CBT-P) improve sleep and clinical pain, their effects on sleep and opioid medication use are unclear. In this secondary analysis of published trial data, we investigated whether CBT-I and CBT-P reduced reliance on sleep/opioid medication in patients with fibromyalgia and insomnia (FMI). Patients with FMI (n = 113, M age   = 53.0, SD = 10.9) completed 8 weeks of CBT-I (n = 39), CBT-P (n = 37) or waitlist control (WLC; n = 37). Participants completed 14 daily diaries at baseline, post-treatment and 6-month follow-up, assessing sleep and opioid medication usage. Multilevel modelling examined group by time effects on days of medication use. A significant interaction revealed CBT-P reduced the number of days of sleep medication use at post-treatment, but usage returned to baseline levels at follow-up. There were no other significant within- or between-group effects. CBT-P led to immediate reductions in sleep medication usage, despite lack of explicit content regarding sleep medication. CBT-I and CBT-P may be ineffective as stand-alone treatments for altering opioid use in FMI. Future work should explore CBT as an adjunct to other behavioural techniques for opioid reduction.",2020,"A significant interaction revealed CBT-P reduced the number of days of sleep medication use at post-treatment, but usage returned to baseline levels at follow-up.","['adults with fibromyalgia and insomnia', 'Patients with FMI (n\xa0=\xa0113, M age  \xa0', 'patients with fibromyalgia and insomnia (FMI']","['cognitive behavioral therapy', 'cognitive behavioural therapy', 'CBT-I and CBT-P reduced reliance']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",[],,0.0245503,"A significant interaction revealed CBT-P reduced the number of days of sleep medication use at post-treatment, but usage returned to baseline levels at follow-up.","[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Nair', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Himangshu', 'Initials': 'H', 'LastName': 'Rathinakumar', 'Affiliation': 'Department of Psychiatry, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Mattina', 'Initials': 'M', 'LastName': 'Davenport', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Jasmine R', 'Initials': 'JR', 'LastName': 'Berry', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGovney', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Berry', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Clinical Health Psychology, University of Florida, Gainesville, FL, USA.'}]",Journal of sleep research,['10.1111/jsr.13020']
125,32223112,Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer.,"BACKGROUND


Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use.
METHODS


This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding.
RESULTS


Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
CONCLUSIONS


Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; Caravaggio ClinicalTrials.gov number, NCT03045406.).",2020,"Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
","['patients with cancer', 'consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive', 'Venous Thromboembolism Associated with Cancer']","['edoxaban or rivaroxaban', 'apixaban', 'Apixaban', 'subcutaneous dalteparin', 'dalteparin', 'oral apixaban']","['Major bleeding', 'recurrent venous thromboembolism', 'Recurrent venous thromboembolism', 'major bleeding', 'risk of major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.301802,"Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Sueiro', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Campanini', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontanella', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Vescovo', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Verso', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915103']
126,32227756,Management of Coronary Disease in Patients with Advanced Kidney Disease.,"BACKGROUND


Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.
METHODS


We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
RESULTS


At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
CONCLUSIONS


Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","['777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an', 'patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease', 'patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia', 'Patients with Advanced Kidney Disease']",['initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy'],"['risk of death or nonfatal myocardial infarction', '3-year event rate', 'composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'composite of death or nonfatal myocardial infarction', 'death or initiation of dialysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",777.0,0.32092,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Evgeny I', 'Initials': 'EI', 'LastName': 'Kretov', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mazurek', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Roy O', 'Initials': 'RO', 'LastName': 'Mathew', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pracon', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915925']
127,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND


Postnatal growth restriction (PNGR) in premature infants increases risk of pulmonary hypertension (PH). In a rodent model, PNGR causes PH, while combining PNGR and hyperoxia increases PH severity. We hypothesized that PNGR causes intestinal dysbiosis and that treatment with a probiotic attenuates PNGR-associated PH.
METHOD


Pups were randomized at birth to room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR (17 pups/dam), and to probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline. After 14 days, PH was assessed by echocardiography and right ventricular hypertrophy (RVH) was assessed by Fulton's index (right ventricular weight/left ventricle + septal weight). The small bowel and cecum were analyzed by high-throughput 16S ribosomal RNA gene sequencing.
RESULTS


PNGR with or without hyperoxia (but not hyperoxia alone) altered the microbiota of the distal small bowel and cecum. Treatment with DSM 17938 attenuated PH and RVH in pups with PNGR, but not hyperoxia alone. DSM 17938 treatment decreased α-diversity. The intestinal microbiota differed based on oxygen exposure, litter size, and probiotic treatment.
CONCLUSION


PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
128,30461405,Difference in Speech Recognition between a Default and Programmed Telecoil Program.,"BACKGROUND


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


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


A single-blinded randomized controlled trial.
STUDY SAMPLE


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


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


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


The programmed telecoil condition revealed significant improvement in speech recognition for all speech stimuli conditions compared with the default telecoil (sentences, monosyllables, and phonemes). Additional improvement was observed in both telecoil conditions when the talker was male.",2019,"Properly used telecoils improve the signal-to-noise ratio (SNR), decrease the chance for acoustic feedback, and overcome the impact of distance and reverberation creating an opportunity for clearer telephone communication.","['ten normal-hearing participants', 'Twenty experienced adult hearing aid users with bilateral symmetric slight to severe sensorineural hearing loss were recruited from Washington University in St. Louis School of Medicine']",[],"['signal-to-noise ratio (SNR', 'telecoil conditions', 'speech recognition', 'overall speech recognition', 'speech recognition for sentences (AZ-BIO) and consonant-vowel nucleus-consonant monosyllabic words (CNC', 'Speech Recognition', 'AZ-BIO sentences (male and female talkers) and CNC monosyllabic words and phonemes']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018784', 'cui_str': 'Hearing Loss, Sensorineural'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",[],"[{'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",20.0,0.0366592,"Properly used telecoils improve the signal-to-noise ratio (SNR), decrease the chance for acoustic feedback, and overcome the impact of distance and reverberation creating an opportunity for clearer telephone communication.","[{'ForeName': 'Kimberly T', 'Initials': 'KT', 'LastName': 'Ledda', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Valente', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Oeding', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Dorina', 'Initials': 'D', 'LastName': 'Kallogjeri', 'Affiliation': 'Division of Adult Audiology, Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.17128']
129,31392827,Net-clinical benefit of extended prophylaxis of venous thromboembolism with betrixaban in medically ill patients aged 80 or more.,"BACKGROUND


Extended-duration thromboprophylaxis with betrixaban reduces the risk of venous thromboembolism (VTE) without increasing major bleeding rates in acutely ill medical patients as compared to standard duration enoxaparin. We aimed to assess the risk-benefit of betrixaban in patients aged ≥ 80 years enrolled in the APEX trial.
METHODS


APEX was a randomized, double-blind trial in which patients hospitalized for acute medical illnesses received enoxaparin 40 mg qd for 10 ± 4 days or oral betrixaban 80 mg qd for 35 to 42 days. The primary efficacy outcome was VTE, the principal safety outcome was major bleeding. Net clinical benefit (NCB) was defined by the occurrence of VTE or major bleeding.
RESULTS


Of 7513 patients enrolled in the APEX trial, 2781 (37%) were aged ≥ 80 years. In this subgroup, VTE or major bleeding occurred in 7.0% of betrixaban patients and in 8.4% of enoxaparin patients, for a relative risk in the NCB of 0.82 (95% confidence interval 0.62-1.10). The relative risk reduction obtained with betrixaban was similar between those aged ≥ 80 years and patients younger than 80 years (5.0% and 6.7%, respectively, NCB 0.75, 0.58-0.96, P = .024), with no significant interaction across age groups (P = .33).
CONCLUSIONS


Event rates were higher in medically ill patients aged ≥ 80 years enrolled in the APEX study than in patients younger than 80 years. The predefined NCB was reduced with extended betrixaban therapy in both groups with no signs of age-related interactions. However, the primary efficacy endpoint was not achieved with betrixaban for patients 80 years of age or older.",2019,The predefined NCB was reduced with extended betrixaban therapy in both groups with no signs of age-related interactions.,"['80\xa0years enrolled in the APEX study than in patients younger than 80\xa0years', 'patients aged\xa0≥\xa080\xa0years enrolled in the APEX trial', 'medically ill patients aged\xa0≥', 'patients 80\xa0years of age or older', 'acutely ill medical patients', '7513 patients enrolled in the APEX trial, 2781 (37%) were aged\xa0≥', 'medically ill patients aged 80 or more', 'patients hospitalized for acute medical illnesses']","['enoxaparin 40\xa0mg qd for 10\xa0±\xa04\xa0days or oral betrixaban', 'extended betrixaban therapy', 'enoxaparin', 'betrixaban']","['VTE, the principal safety outcome was major bleeding', 'relative risk reduction obtained with betrixaban', 'VTE or major bleeding']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2698385', 'cui_str': 'betrixaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C2698385', 'cui_str': 'betrixaban'}]",,0.164064,The predefined NCB was reduced with extended betrixaban therapy in both groups with no signs of age-related interactions.,"[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Megan K', 'Initials': 'MK', 'LastName': 'Yee', 'Affiliation': 'Boston Clinical Research Institute, Newton, Massachusetts.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hernandez', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Hull', 'Affiliation': 'R.A.H Faculty of Medicine, Division of Cardiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Boston Clinical Research Institute, Newton, Massachusetts.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Cohen', 'Affiliation': ""Department of Haematological Medicine, Guy's and St Thomas' Hospitals, London, UK.""}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14600']
130,30585532,"Can addiction counselors be trained to deliver Mothering from the Inside Out, a mentalization-based parenting therapy, with fidelity? Results from a community-based randomized efficacy trial.","This study evaluated methods for training community-based clinicians to deliver a mentalization-based parenting intervention in an addiction treatment setting. Mothering from the Inside Out (MIO) targets psychological deficits associated with early stages of addiction recovery by fostering improvement in parental reflective functioning, the capacity to make sense of strong emotions in oneself and the child. Fifteen addiction counselors were randomized to training in MIO versus a Parent Education comparison, and completed eight training sessions and a clinically-supervised 12-session training case. As predicted, MIO and PE counselors demonstrated fidelity to their respective interventions during the training case. At the end of training, MIO counselors showed greater improvement than PE counselors in clinical reflective functioning, the capacity to make sense of a patients' mental and emotional experiences. Implications for training community-based counselors in evidence-based attachment interventions are explored.",2020,"At the end of training, MIO counselors showed greater improvement than PE counselors in clinical reflective functioning, the capacity to make sense of a patients' mental and emotional experiences.",['Fifteen addiction counselors'],"['training in MIO versus a Parent Education comparison, and completed eight training sessions and a clinically-supervised 12-session training case', 'mentalization-based parenting intervention']",[],"[{'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C4704687', 'cui_str': 'Mentalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],15.0,0.0222944,"At the end of training, MIO counselors showed greater improvement than PE counselors in clinical reflective functioning, the capacity to make sense of a patients' mental and emotional experiences.","[{'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Suchman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Borelli', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA, USA.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'DeCoste', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}]",Attachment & human development,['10.1080/14616734.2018.1559210']
131,32317292,"Results of a randomized, double-blind phase II clinical trial of NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in participants with high-risk resected melanoma.","BACKGROUND


To compare the clinical efficacy of New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone in a randomized, double-blind phase II study in participants with fully resected melanoma at high risk of recurrence.
METHODS


Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1 were randomized to treatment with three doses of NY-ESO-1/ISCOMATRIX or ISCOMATRIX adjuvant administered intramuscularly at 4-week intervals, followed by a further dose at 6 months. Primary endpoint was the proportion free of relapse at 18 months in the intention-to-treat (ITT) population and two per-protocol populations. Secondary endpoints included relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity.
RESULTS


The ITT population comprised 110 participants, with 56 randomized to NY-ESO-1/ISCOMATRIX and 54 to ISCOMATRIX alone. No significant toxicities were observed. There were no differences between the study arms in relapses at 18 months or for median time to relapse; 139 vs 176 days (p=0.296), or relapse rate, 27 (48.2%) vs 26 (48.1%) (HR 0.913; 95% CI 0.402 to 2.231), respectively. RFS and OS were similar between the study arms. Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4 +  and CD8 +  responses. Biopsies following relapse did not demonstrate differences in NY-ESO-1 expression between the study populations although an exploratory study demonstrated reduced (NY-ESO-1) + /Human Leukocyte Antigen (HLA) class I +  double-positive cells in biopsies from vaccine recipients performed on relapse in 19 participants.
CONCLUSIONS


The vaccine was well tolerated, however, despite inducing antigen-specific immunity, it did not affect survival endpoints. Immune escape through the downregulation of NY-ESO-1 and/or HLA class I molecules on tumor may have contributed to relapse.",2020,Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4 +  and CD8 +  responses.,"['participants with fully resected melanoma at high risk of recurrence', 'Participants with resected stage IIc, IIIb, IIIc and IV melanoma expressing NY-ESO-1', 'participants with high-risk resected melanoma', 'biopsies from vaccine recipients performed on relapse in 19 participants']","['NY-ESO-1 vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone', 'HLA class', 'Vaccine', 'New York Esophageal squamous cell carcinoma-1 (NY-ESO-1) vaccine with ISCOMATRIX adjuvant versus ISCOMATRIX alone']","['relapse rate', 'toxicities', 'strong positive antibody responses', 'median time to relapse', 'proportion free of relapse', 'relapse-free survival (RFS) and overall survival (OS), safety and NY-ESO-1 immunity', 'RFS and OS', 'Leukocyte Antigen (HLA) class']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441770', 'cui_str': 'Stage 2C'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0536940', 'cui_str': 'CTAG1 protein, human'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0536940', 'cui_str': 'CTAG1 protein, human'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1529741', 'cui_str': 'ISCOMATRIX'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0536940', 'cui_str': 'CTAG1 protein, human'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",,0.62737,Vaccine recipients developed strong positive antibody responses to NY-ESO-1 (p≤0.0001) and NY-ESO-1-specific CD4 +  and CD8 +  responses.,"[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Cebon', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia j.cebon@onjcri.org.au.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gore', 'Affiliation': 'Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Thompson', 'Affiliation': 'Melanoma Institute Australia, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Ludwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'McArthur', 'Affiliation': 'Melanona and Skin Service, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Euan', 'Initials': 'E', 'LastName': 'Walpole', 'Affiliation': 'Cancer Services Division, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Smithers', 'Affiliation': 'Oncology Services Unit, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cerundolo', 'Affiliation': 'MRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, Oxford, Oxfordshire, UK.'}, {'ForeName': 'P Rod', 'Initials': 'PR', 'LastName': 'Dunbar', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'MacGregor', 'Affiliation': 'Department of Anatomical Pathology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Fisher', 'Affiliation': 'Oncology, Royal Marsden Hospital NHS Trust, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Millward', 'Affiliation': 'School of Medicine and Pharmacology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nathan', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, London, UK.'}, {'ForeName': 'Michael P N', 'Initials': 'MPN', 'LastName': 'Findlay', 'Affiliation': 'School of Medicine and Health Science, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hersey', 'Affiliation': 'Melanoma Immunology and Oncology Group, Centenary Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'T R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Christian Hermann', 'Initials': 'CH', 'LastName': 'Ottensmeier', 'Affiliation': 'School of Cancer Sciences, University of Southampton Faculty of Medicine, Southampton, Hampshire, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Dalgleish', 'Affiliation': 'Cell and Molecular Sciences, Division of Oncology, St Georges Hospital Medical School, London, UK.'}, {'ForeName': 'Pippa G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""West Anglia Cancer Research Network Oncology Centre, Addenbrooke's Hospital, Cambridge, Cambridgeshire, UK.""}, {'ForeName': 'Marples', 'Initials': 'M', 'LastName': 'Maria', 'Affiliation': 'The Cancer Research Centre, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Brimble', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sintia', 'Initials': 'S', 'LastName': 'Winkler', 'Affiliation': 'School of Biological Sciences and Maurice Wilkins Centre, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Jackson', 'Affiliation': 'Ludwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Endo-Munoz', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Candani S A', 'Initials': 'CSA', 'LastName': 'Tutuka', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Venhaus', 'Affiliation': 'Ludwig Institute for Cancer Research, New York, New York, USA.'}, {'ForeName': 'Lloyd J', 'Initials': 'LJ', 'LastName': 'Old', 'Affiliation': 'Ludwig Institute for Cancer Research, New York, New York, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Haack', 'Affiliation': 'Versagenics Inc, Morrisville, North Carolina, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Maraskovsky', 'Affiliation': 'CSL Limited, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Behren', 'Affiliation': 'Cancer Immunobiology Programme, Olivia Newton-John Cancer Research Institute, School of Cancer Medicine, La Trobe University at Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Weisan', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Ludwig Institute for Cancer Research Austin Branch, Heidelberg, Victoria, Australia.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000410']
132,32317470,Comparison of platelet-rich plasma and inverted internal limiting membrane flap for the management of large macular holes: A pilot study.,"Purpose


To compare the safety and efficacy of 25-gauge pars plana vitrectomy (PPV) with either platelet-rich plasma (PRP) or inverted internal limiting membrane (ILM) flap for the treatment of large macular hole.
Methods


Pseudophakic patients with idiopathic macular holes with a minimum diameter (MD) of 600-1500 μm were randomized into two groups (30 patients each): 25-gauge PPV with either inverted ILM flap (group A) or PRP (group B).
Results


Mean MD in groups A and B were 803.33 ± 120.65 μm and 784.73 ± 120.10 μm, respectively (P = 0.552). Mean base diameter in groups A and B was 1395.17 ± 240.57 μm and 1486.90 ± 281.61 μm, respectively (P = 0.180). The median presenting best-corrected visual acuity (BCVA) was logMAR 0.78 (range 0.78-1.00) and logMAR 0.78 (Range 0.60-1.00) in groups A and B, respectively (P = 0.103). Anatomical closure was achieved in 90% (n = 27/30) and 93.3% (n = 28/30) eyes in groups A and B, respectively (P = 0.158). Type 1 closure was achieved in 76.7% (n = 23/30) and 83.3% (n = 25/30) eyes in groups A and B, respectively. Median BCVA at postoperative 3-month in groups A and B was logMAR 0.60 (range 0.48-0.60) and logMAR 0.60 (range 0.48-0.78), respectively (P = 0.312). The average visual improvement was 2.0 and 2.5 early treatment diabetic retinopathy study (ETDRS) lines in groups A and B, respectively (P = 0.339). None of the patients developed postoperative exaggerated inflammatory reactions.
Conclusion


Using platelets for the treatment of large macular holes is as safe and effective as an inverted ILM flap.",2020,"Anatomical closure was achieved in 90% (n = 27/30) and 93.3% (n = 28/30) eyes in groups A and B, respectively (P = 0.158).","['large macular holes', 'large macular hole', 'Pseudophakic patients with idiopathic macular holes with a minimum diameter (MD) of 600-1500 μm were randomized into two groups (30 patients each']","['PRP', '25-gauge pars plana vitrectomy (PPV) with either platelet-rich plasma (PRP) or inverted internal limiting membrane (ILM) flap', '25-gauge PPV with either inverted ILM flap', 'platelet-rich plasma and inverted internal limiting membrane flap']","['median presenting best-corrected visual acuity (BCVA', 'average visual improvement', 'Median BCVA', 'Anatomical closure', 'safety and efficacy', 'postoperative exaggerated inflammatory reactions']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C4522321', 'cui_str': 'Inverted'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0280209,"Anatomical closure was achieved in 90% (n = 27/30) and 93.3% (n = 28/30) eyes in groups A and B, respectively (P = 0.158).","[{'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Babu', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Piyush', 'Initials': 'P', 'LastName': 'Kohli', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'N Obuli', 'Initials': 'NO', 'LastName': 'Ramachandran', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Olukorede O', 'Initials': 'OO', 'LastName': 'Adenuga', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Ahuja', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Vitreo-Retinal Services, Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Madurai, Tamil Nadu, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_1357_19']
133,32101336,"Comparison of woman-picked, expert-picked, and computer-picked Peak Day of cervical mucus with blinded urine luteinising hormone surge for concurrent identification of ovulation.","BACKGROUND


Previous research has demonstrated that women instructed in fertility awareness methods can identify the Peak Day of cervical mucus discharge for each menstrual cycle, and the Peak Day has high agreement with other indicators of the day of ovulation. However, previous studies enrolled experienced users of fertility awareness methods or were not fully blinded.
OBJECTIVE


To assess the agreement between cervical mucus Peak Day identified by fertile women without prior experience on assessing cervical mucus discharge with the estimated day of ovulation (1 day after urine luteinising hormone surge).
METHODS


This study is a secondary analysis of data from a randomised trial of the Creighton Model FertilityCare TM  System (CrM), conducted 2003-2006, for women trying to conceive. Women who had no prior experience tracking cervical mucus recorded vulvar observations daily using a standardised assessment of mucus characteristics for up to seven menstrual cycles. Four approaches were used to identify the Peak Day. The referent day was defined as one day after the first identified day of luteinising hormone (LH) surge in the urine, assessed blindly. The percentage of agreement between the Peak Day and the referent day of ovulation was calculated.
RESULTS


Fifty-seven women with 187 complete cycles were included. A Peak Day was identified in 117 (63%) cycles by women, 185 (99%) cycles by experts, and 187 (100%) by computer algorithm. The woman-picked Peak Day was the same as the referent day in 25% of 117 cycles, within ±1 day in 58% of cycles, ±2 days in 84%, ±3 days in 87%, and ±4 days in 92%. The ±1 day and ± 4 days' agreement was 50% and 90% for the expert-picked and 47% and 87% for the computer-picked Peak Day, respectively.
CONCLUSIONS


Women's daily tracking of cervical mucus is a low-cost alternative for identifying the estimated day of ovulation.",2020,"4 days' agreement was 50% and 90% for the expert-picked and 47% and 87% for the computer-picked Peak Day, respectively.
","['Women who had no prior experience tracking cervical mucus', 'women trying to conceive', 'Fifty-seven women with 187 complete cycles were included']",['Creighton Model FertilityCare TM  System (CrM'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0007872', 'cui_str': 'Cervical Mucus'}, {'cui': 'C0420843', 'cui_str': 'Trying to conceive (finding)'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],57.0,0.0873437,"4 days' agreement was 50% and 90% for the expert-picked and 47% and 87% for the computer-picked Peak Day, respectively.
","[{'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Stanford', 'Affiliation': 'Office of Cooperative Reproductive Health, Division of Public Health, Department of Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Schliep', 'Affiliation': 'Office of Cooperative Reproductive Health, Division of Public Health, Department of Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Chun-Pin', 'Initials': 'CP', 'LastName': 'Chang', 'Affiliation': 'Office of Cooperative Reproductive Health, Division of Public Health, Department of Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': ""O'Sullivan"", 'Affiliation': 'Greater Glasgow Health Board, Glasgow, UK.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Porucznik', 'Affiliation': 'Office of Cooperative Reproductive Health, Division of Public Health, Department of Family & Preventive Medicine, University of Utah School of Medicine, Salt Lake City, UT, USA.'}]",Paediatric and perinatal epidemiology,['10.1111/ppe.12642']
134,31605793,A Randomized Double-Blind Phase II Study of the Seneca Valley Virus (NTX-010) versus Placebo for Patients with Extensive-Stage SCLC (ES SCLC) Who Were Stable or Responding after at Least Four Cycles of Platinum-Based Chemotherapy: North Central Cancer Treatment Group (Alliance) N0923 Study.,"INTRODUCTION


The Seneca Valley virus (NTX-010) is an oncolytic picornavirus with tropism for SCLC. This phase II double-blind, placebo-controlled trial evaluated NTX-010 in patients with extensive-stage (ES) SCLC after completion of first-line chemotherapy.
METHODS


Patients with ES SCLC who did not progress after four or more cycles of platinum-based chemotherapy were randomized 1:1 to a single dose of NTX-010 or placebo within 12 weeks of chemotherapy. The primary end point was progression-free survival (PFS). A prespecified interim analysis for futility was performed after 40 events. Viral clearance and the development of neutralizing antibodies were followed.
RESULTS


From January 15, 2010, to January 10, 2013, a total of 50 patients were randomized and received therapy on study (26 received NTX-010 and 24 received placebo). At the specified interim analysis, the median PFS was 1.7 months (95% confidence interval [CI]: 1.4-3.1 months) for the NTX-010 group versus 1.7 months (95% CI: 1.4-4.3 months) for the placebo group (hazard ratio = 1.03, p = 0.92), and the trial was terminated owing to futility. In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus in those in whom it was not detected after treatment (1.0 month [95% CI: 0.4-1.5 months] versus 1.8 months [95% CI: 1.3-5.5 months, p = 0.008] and 0.9 months [95% CI: 0.4-2.6 months] versus 1.3 months [95% CI: 1.0-5.3 months], respectively [p = 0.04]).
CONCLUSIONS


Patients with ES SCLC did not benefit from NTX-010 treatment after chemotherapy with a platinum doublet. Persistence of NTX-010 in the blood 1 or 2 weeks after treatment was associated with a shorter PFS.",2020,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","['patients with extensive stage (ES) SCLC after completion of first line chemotherapy', 'patients with extensive stage SCLC (ES-SCLC) who were stable or responding after at least 4 cycles of platinum-based chemotherapy: NCCTG (Alliance) N0923 Study', 'ES-SCLC patients who did not progress after ≥4 cycles of platinum-based chemotherapy', 'From January 15, 2010 to January 10, 2013, 50 patients']","['Seneca Valley Virus (NTX-010) vs placebo', 'placebo', 'NTX-010', 'NTX-010 or placebo']","['progression free survival (PFS', 'median PFS', 'Viral clearance and the development of neutralizing antibodies', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C1831871', 'cui_str': 'Senecavirus A'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",50.0,0.392168,"In the NTX-010 group, PFS was shorter in patients with detectable virus at days 7 and 14 versus not detected after treatment (1.0 month (95% CI 0.4-1.5 months) vs 1.8 months (95% CI 1.3-5.5 months; p=0.008); and 0.9 months (95% CI 0.4-2.6 months) vs 1.3 months (95% CI 1.0-5.3 months), p=0.04) respectively.
","[{'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Schenk', 'Affiliation': 'University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Grace K', 'Initials': 'GK', 'LastName': 'Dy', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Marie Christine', 'Initials': 'MC', 'LastName': 'Aubry', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Newton, Kansas.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Sachs', 'Affiliation': 'The Toledo Clinic-Maumee, Maumee, Ohio.'}, {'ForeName': 'Jorge J', 'Initials': 'JJ', 'LastName': 'Nieva', 'Affiliation': 'University of Southern California, Los Angeles, California.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Bertino', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lee Hann', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Troy W', 'Initials': 'TW', 'LastName': 'Wadsworth', 'Affiliation': 'Northwest NCORP, Multicare Regional Cancer Center, Tacoma, Washington.'}, {'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Adjei', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julian R', 'Initials': 'JR', 'LastName': 'Molina', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota. Electronic address: molina.julian@mayo.edu.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.09.083']
135,31970796,Elicitation of prior probability distributions for a proposed Bayesian randomized clinical trial of whole blood for trauma resuscitation.,"BACKGROUND


Whole blood trauma resuscitation is conceptually appealing and increasingly used but lacks evidence. A randomized controlled trial is needed but challenging to design. A Bayesian approach might be more efficient and more interpretable than a conventional frequentist design. We report the results on an elicitation meeting to create prior probability distributions to help develop such a trial.
METHODS


In-person expert elicitation meeting, based on Sheffield Elicitation Framework methodology. We used an interactive graphical tool to elicit the quantities of interest (24-hour mortality and certainty required). Two rounds were conducted, with an intervening discussion of deidentified responses. Individual responses were aggregated into probability distributions.
RESULTS


Fifteen experts participated. The pooled belief was that the median 24-hour mortality of trauma patients with hemorrhagic shock treated with component therapy (the current standard of care) was 19% (95% credible interval [CrI], 6%-45%), and the median 24-hour mortality of those treated with whole blood, 16% (95% CrI, 5%-39%). The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy.
CONCLUSIONS


Experts had moderately strong beliefs that whole blood reduces the 24-hour mortality of trauma patients with hemorrhagic shock. These data will assist with the design and planning of a Bayesian trial of whole blood resuscitation, which will help to answer a key question in contemporary transfusion practice.",2020,"The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy.
","['In-person expert elicitation meeting, based on Sheffield Elicitation Framework methodology', 'Fifteen experts participated', 'trauma patients with hemorrhagic shock']",[],"['median 24-hour mortality', '24-hour mortality']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",2.0,0.0639189,"The pooled prior distribution for the relative risk had a median of 0.84 (95% CrI, 0.26-3.1), indicating that the expert group had a 64% prior belief that whole blood decreases 24-hour mortality compared to component therapy.
","[{'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Jansen', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Harvin', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Richman', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Elenir', 'Initials': 'E', 'LastName': 'Avritscher', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Shannon W', 'Initials': 'SW', 'LastName': 'Stephens', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Van Thi Thanh', 'Initials': 'VTT', 'LastName': 'Truong', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Marisa B', 'Initials': 'MB', 'LastName': 'Marques', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Stacia M', 'Initials': 'SM', 'LastName': 'DeSantis', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Jose-Miguel', 'Initials': 'JM', 'LastName': 'Yamal', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, Texas.'}]",Transfusion,['10.1111/trf.15675']
136,32321385,"Effects of 8-week endurance and resistance training programmes on cardiovascular stress responses, life stress and coping.","This study tested the effect of 8-week endurance and resistance training programmes on cardiovascular stress responses, life stress, and coping. Fifty-two untrained but healthy female students were randomised to an 8-week endurance training, an 8-week resistance training, or a wait list control group. Before and after the training intervention, we assessed the groups' cardiorespiratory fitness (VO2max test), self-reported life stress, coping strategies and cardiovascular reactivity to and recovery from a standardised laboratory stressor. Both endurance and resistance training programmes caused physiological adaptation in terms of increased VO2max after the intervention. For stress and coping parameters, participants in the training groups improved cardiovascular recovery from stress and reported having less stress in their everyday life after the intervention than participants in the control group, while the two training groups did not differ from each other. We did not find any significant differences in heart rate reactivity and coping strategies between the study groups. These results partly support that exercise training has stress-reducing benefits regardless of the type of exercise. Both endurance and resistance exercise activities may be effectively used to improve stress regulation competence while having less impact on changing specific coping strategies.",2020,We did not find any significant differences in heart rate reactivity and coping strategies between the study groups.,['Fifty-two untrained but healthy female students'],"['exercise training', '8-week endurance training, an 8-week resistance training, or a wait list control group', '8-week endurance and resistance training programmes']","['cardiovascular stress responses, life stress and coping', 'heart rate reactivity and coping strategies', 'everyday life', 'cardiovascular stress responses, life stress, and coping', 'cardiovascular recovery', 'cardiorespiratory fitness (VO2max test), self-reported life stress, coping strategies and cardiovascular reactivity to and recovery from a standardised laboratory stressor']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",,0.0186328,We did not find any significant differences in heart rate reactivity and coping strategies between the study groups.,"[{'ForeName': 'Lukáš', 'Initials': 'L', 'LastName': 'Chovanec', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University in Bratislava , Bratislava, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gröpel', 'Affiliation': 'Department of Applied Psychology, Work, Education, and Economy, University of Vienna , Vienna, Austria.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756672']
137,32297923,Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair: The PostRD Randomized Clinical Trial.,"Importance


A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair.
Objective


To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair.
Design, Setting, and Participants


A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis.
Interventions


Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored.
Main Outcomes and Measures


The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months.
Results


Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008).
Conclusions and Relevance


In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion.
Trial Registration


ClinicalTrials.gov Identifier: NCT02748538.",2020,"Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008).
","['multicenter tertiary referral setting from May 16, 2016, to May 1, 2018', '239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years', 'Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older', 'patients after macula-involving retinal detachment (RD) repair', 'patients experiencing a redetachment or failure to attach the macula being excluded from analysis', '262 randomized patients']","['face-down positioning vs support-the-break positioning', 'Face-Down Positioning vs Support-the-Break Positioning', 'Macula-Involving Retinal Detachment Repair', 'face-down positioning or support-the-break positioning for a 24-hour period postoperatively']","['visual acuity or postoperative distortion', 'worse visual acuity', 'Retinal redetachment rate', 'degree of displacement', 'quality of life scores', 'retinal displacement', 'Binocular diplopia', 'corrected visual acuity', 'proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores', 'objective D Chart Distortion Scores (range']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0303720', 'cui_str': 'Americium-239'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0016622', 'cui_str': 'Structure of fovea centralis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0227662', 'cui_str': 'Structure of macula densa'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0227662', 'cui_str': 'Structure of macula densa'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0197839', 'cui_str': 'Repair of retina for retinal detachment'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0422985', 'cui_str': 'Binocular diplopia'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",262.0,0.188557,"Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008).
","[{'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Casswell', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yorston', 'Affiliation': 'Tennent Institute of Ophthalmology, Gartnavel Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Tjebo F C', 'Initials': 'TFC', 'LastName': 'Heeren', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Tapiwa Margaret', 'Initials': 'TM', 'LastName': 'Zvobgo', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Tarafdar', 'Affiliation': 'Tennent Institute of Ophthalmology, Gartnavel Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xing', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Elli', 'Initials': 'E', 'LastName': 'Bourmpaki', 'Affiliation': ""Unit of Medical Statistics, Faculty of Life Sciences, King's College London School of Population Health & Environmental Sciences, London, United Kingdom.""}, {'ForeName': 'Catey', 'Initials': 'C', 'LastName': 'Bunce', 'Affiliation': ""Unit of Medical Statistics, Faculty of Life Sciences, King's College London School of Population Health & Environmental Sciences, London, United Kingdom.""}, {'ForeName': 'Pearse', 'Initials': 'P', 'LastName': 'Keane', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Charteris', 'Affiliation': 'Department of Ophthalmology, Moorfields Eye Hospital, London, United Kingdom.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0997']
138,32297945,Effect of Treatment Expectation on Placebo Response and Analgesic Efficacy: A Secondary Aim in a Randomized Clinical Trial.,,2020,,[],[],['Placebo Response and Analgesic Efficacy'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.420829,,"[{'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Sanders', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Slade', 'Affiliation': 'Division of Pediatric and Public Health, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ohrbach', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University at Buffalo, State University of New York, Buffalo.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Arbes', 'Affiliation': 'Rho Inc, Durham, North Carolina.'}, {'ForeName': 'Inna E', 'Initials': 'IE', 'LastName': 'Tchivileva', 'Affiliation': 'Division of Oral and Craniofacial Health Sciences, Adams School of Dentistry, University of North Carolina at Chapel Hill.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.2907']
139,32319999,Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Despite evidence that guideline-directed medical therapy (GDMT) improves outcomes in patients with heart failure (HF) and reduced ejection fraction, many patients are undertreated. The Guiding Evidence-Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT) trial tested whether a strategy of using target concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) to guide optimization of GDMT could improve outcomes.
Objective


To examine medical therapy for HF in GUIDE-IT and potential reasons why the intervention did not produce improvements in medical therapy.
Design, Setting, and Participants


GUIDE-IT, a randomized clinical trial performed at 45 sites in the United States and Canada, was conducted from January 16, 2013, to September 20, 2016. A total of 894 patients with HF and reduced ejection fraction (≤40%) were randomized to NT-proBNP-guided treatment with a goal to suppress NT-proBNP concentrations to less than 1000 pg/mL vs usual care. This secondary analysis examined the medical therapy titration and reasons why the intervention did not produce improvements in care and outcomes. Data were analyzed March 27 to June 28, 2019.
Main Outcomes and Measures


For each encounter, medication titrations were captured. A reason was requested if a modification was not made. A Cox proportional hazards regression model was used to assess the independent association of drug class with outcomes.
Results


Among the 838 patients available for analysis (566 men [67.5%]; median age, 62.0 years), 6223 visits occurred during 24 months. Adjustments of HF medication were made during 2847 of 5218 qualified visits (54.6%) (all usual care visits and all guided care visits with NT-proBNP level ≥1000 pg/mL) in 862 patients (96.4%). Most adjustments occurred within the first 6 months, primarily within the first 6 weeks. The most common reasons for not adjusting were ""clinically stable"" and ""already at maximally tolerated therapy."" Only 130 patients (15.5%) achieved optimal GDMT (≥50% of the target dose of β-blockers or angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or any dose of mineralocorticoid antagonists) at 6 months, an increase from the baseline (79 of 891 [8.9%]) but not different by treatment arm. Higher doses of β-blockers were associated with reduced risk of the composite outcome of HF hospitalization and cardiovascular death (hazard ratio [HR], 0.98; 95% CI, 0.97-1.00; P = .008) and of all-cause death (HR, 0.97; 95% CI, 0.95-0.99; P = .01). Higher doses of angiotensin-converting enzyme inhibitors (HR, 0.84; 95% CI, 0.75-0.93; P < .001) and angiotensin receptor blockers (HR, 0.84; 95% CI, 0.71-0.99; P = .04) were associated with reduced risk of all-cause death. Increasing doses of mineralocorticoid antagonists did not appear to be associated with improved outcomes.
Conclusions and Relevance


Despite a protocol-driven approach, many patients in GUIDE-IT did not receive medication adjustments and did not achieve optimal GDMT, including those with known elevated NT-proBNP concentrations. These results suggest that opportunities exist to titrate medications for maximal benefit in HF. GUIDE-IT may have failed to achieve treatment benefit because of therapeutic inertia in clinical practice, or current GDMT goals may be unrealistic.
Trial Registration


ClinicalTrials.gov Identifier: NCT01685840.",2020,"Higher doses of β-blockers were associated with reduced risk of the composite outcome of HF hospitalization and cardiovascular death (hazard ratio [HR], 0.98; 95% CI, 0.97-1.00; P = .008) and of all-cause death (HR, 0.97; 95% CI, 0.95-0.99; P = .01).","['45 sites in the United States and Canada, was conducted from January 16, 2013, to September 20, 2016', '838 patients available for analysis (566 men [67.5%]; median age, 62.0 years), 6223 visits occurred during 24 months', 'patients with heart failure (HF', '894 patients with HF and reduced ejection fraction (≤40']","['NT-proBNP-guided treatment with a goal to suppress NT-proBNP concentrations to less than 1000 pg/mL vs usual care', 'Guideline-Directed Medical Therapy', 'angiotensin-converting enzyme inhibitors', 'guideline-directed medical therapy (GDMT']","['angiotensin receptor blockers', 'Measures\n\n\nFor each encounter, medication titrations', 'reduced risk of the composite outcome of HF hospitalization and cardiovascular death', 'optimal GDMT']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]",894.0,0.125518,"Higher doses of β-blockers were associated with reduced risk of the composite outcome of HF hospitalization and cardiovascular death (hazard ratio [HR], 0.98; 95% CI, 0.97-1.00; P = .008) and of all-cause death (HR, 0.97; 95% CI, 0.95-0.99; P = .01).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'University Medical Center and Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'Heart Function Clinic, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Wendimagegn', 'Initials': 'W', 'LastName': 'Alemayehu', 'Affiliation': 'Canadian VIGOUR Centre, Katz Group Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Canadian VIGOUR Centre, Katz Group Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sbolli', 'Affiliation': 'Department of Cardiology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cani', 'Affiliation': 'Department of Cardiology, University of Brescia, Brescia, Italy.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Division of Cardiology, Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Kirkwood', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'Department of Cardiology, University of North Carolina School of Medicine, Chapel Hill.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Division of Cardiology, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'University Medical Center and Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'University Medical Center and Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mark', 'Affiliation': 'University Medical Center and Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'University Medical Center and Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Baim Institute for Clinical Research, Cardiology Division, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'University Medical Center and Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0640']
140,32203675,Comparison of Tendon Lengthening With Traditional Versus Accelerated Rehabilitation After Achilles Tendon Repair: A Prospective Randomized Controlled Trial.,"BACKGROUND


Early weightbearing protocols after Achilles tendon repair promote mobilization, yet little is known about their effect on tendon lengthening.
PURPOSE


To evaluate tendon lengthening after Achilles tendon repair with accelerated rehabilitation.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Patients undergoing primary repair for acute Achilles tendon ruptures consented to have tantalum beads placed within the tendon. Patients were randomized into either a traditional (weightbearing at 6 weeks) or accelerated (graduated weightbearing at 2 weeks) rehabilitation group. The primary outcome of the study was postoperative tendon elongation as measured by radiostereometric beads. Secondary outcomes included Achilles Tendon Total Rupture Score (ATRS) and Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (PROMIS PI-SF) score.
RESULTS


All 18 patients included in the final analysis were found to have significant tendon lengthening after surgery, with a mean lengthening of 15.9 mm. No significant differences were found in overall lengthening between the traditional and accelerated rehabilitation groups (15.3 ± 4.5 vs 16.4 ± 4.7 mm, respectively;  P  = .33) at final follow-up. The repair site in each group was found to lengthen more than the intratendinous site (traditional group, 13.2 vs 2.1 mm; accelerated group, 16.8 vs -0.4 mm); however, no difference in lengthening was seen between groups ( P  = .82 and  P  = .31, respectively). The greatest amount of lengthening occurred between 2 and 6 weeks, and the least amount of lengthening occurred between 6 and 12 weeks, with no difference between the traditional and accelerated groups at these time points ( P  = .84 and  P  = .38, respectively). No differences were noted in ankle range of motion (dorsiflexion,  P  = .16; plantarflexion,  P  = .08) or outcome scores (ATRS,  P  = .56; PROMIS PI-SF,  P  = .54).
CONCLUSION


This study's findings demonstrate that all patients undergoing operative repair of Achilles tendon ruptures had lengthening after surgery. No difference was found in tendon lengthening (repair site or intratendinous) at any time point between patients undergoing traditional versus accelerated rehabilitation postoperatively. The greatest amount of lengthening was found to occur between 2 and 6 weeks postoperatively, and tendon lengthening decreased significantly after 6 weeks.
REGISTRATION


NCT04050748 (ClinicalTrials.gov identifier).",2020,"No differences were noted in ankle range of motion (dorsiflexion,  P  = .16; plantarflexion,  P  = .08) or outcome scores (ATRS,  P  = .56; PROMIS PI-SF,  P  = .54).
","['Patients undergoing primary repair for acute Achilles tendon ruptures consented to have tantalum beads placed within the tendon', 'patients undergoing operative repair of Achilles tendon ruptures had lengthening after surgery', 'After Achilles Tendon Repair']","['Lengthening With Traditional Versus Accelerated Rehabilitation', 'traditional (weightbearing at 6 weeks) or accelerated (graduated weightbearing at 2 weeks) rehabilitation group', 'tendon lengthening after Achilles tendon repair with accelerated rehabilitation', 'Tendon']","['ankle range of motion (dorsiflexion', 'tendon lengthening (repair site or intratendinous', 'greatest amount of lengthening', 'least amount of lengthening', 'Achilles Tendon Total Rupture Score (ATRS) and Patient-Reported Outcomes Measurement Information System Pain Interference Short Form (PROMIS PI-SF) score', 'overall lengthening', 'postoperative tendon elongation', 'tendon lengthening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0039297', 'cui_str': 'Tantalum'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0407029', 'cui_str': 'Repair of tendo achilles (procedure)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}]","[{'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0521110', 'cui_str': 'Accelerated (contextual qualifier) (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1318107', 'cui_str': 'Loadbearing'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0407029', 'cui_str': 'Repair of tendo achilles (procedure)'}]","[{'cui': 'C0576183', 'cui_str': 'Joint movement: ankle'}, {'cui': 'C0441593', 'cui_str': 'Tendon Lengthening'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021428', 'cui_str': 'Information Systems'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392744', 'cui_str': 'Lengthened (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}]",18.0,0.140827,"No differences were noted in ankle range of motion (dorsiflexion,  P  = .16; plantarflexion,  P  = .08) or outcome scores (ATRS,  P  = .56; PROMIS PI-SF,  P  = .54).
","[{'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Okoroha', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Najib', 'Initials': 'N', 'LastName': 'Ussef', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Toufic R', 'Initials': 'TR', 'LastName': 'Jildeh', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Lafi S', 'Initials': 'LS', 'LastName': 'Khalil', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Laith', 'Initials': 'L', 'LastName': 'Hasan', 'Affiliation': 'Tulane University Medical School, New Orleans, Louisiana, USA.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Bench', 'Affiliation': 'Wayne State University School of Medicine, Detroit, Michigan, USA.'}, {'ForeName': 'Ferras', 'Initials': 'F', 'LastName': 'Zeni', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Eller', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Moutzouros', 'Affiliation': 'Department of Orthopaedic Surgery, Henry Ford Hospital, Detroit, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520909389']
141,31529590,"Randomized phase 2 trial comparing JNJ-9375, a thrombin-directed antibody, with apixaban for prevention of venous thrombosis.","BACKGROUND


JNJ-9375 is an antibody against exosite 1 on thrombin, inhibits substrate binding but not catalytic activity.
OBJECTIVE


To examine the possibility that JNJ-9375 attenuates thrombosis without affecting hemostasis, we compared the efficacy and safety of JNJ-9375 and apixaban.
METHODS


In this double-blind, double-dummy phase 2 trial, 308 patients undergoing knee arthroplasty were randomized to receive either a single postoperative intravenous infusion of JNJ-9375 in doses ranging from 0.3 to 1.8 mg/kg or apixaban (2.5 mg twice daily). The primary efficacy endpoint was the incidence of venous thromboembolism (assessed by mandatory unilateral venography or confirmed symptomatic events). The primary safety outcome was the composite of major, clinically relevant nonmajor, and minimal bleeding. Thrombin times were measured to assess JNJ-9375 activity.
RESULTS


A total of 239 of the 308 patients (77.6%) were included in the modified intention-to-treat analysis. Of these, 238 had evaluable venograms and one had symptomatic deep-vein thrombosis confirmed by ultrasound. Despite dose-dependent thrombin time prolongation, the primary efficacy outcome occurred in 59 of 190 patients (31.1%) in the combined JNJ-9375 groups as compared with 6 of 49 patients (12.2%) given apixaban (odds ratio 3.2; two-sided 80% confidence interval 1.8-5.8; P = .011). The excess events with JNJ-9375 compared with apixaban were consistent across all JNJ-9375 dosing cohorts and there was no evidence of improved efficacy with higher JNJ-9375 doses. There were no major bleeds with JNJ-9375 or apixaban, and rates of any bleeding were similar with the highest and lowest JNJ-9375 doses.
CONCLUSIONS


JNJ-9375 was safe but less effective than apixaban. This may reflect weak thrombin inhibition or inability of JNJ-9375 to attenuate the growth of thrombi that formed before drug administration.",2019,"There were no major bleeds with JNJ-9375 or apixaban, and rates of any bleeding were similar with the highest and lowest JNJ-9375 doses.
","['308 patients undergoing knee arthroplasty', 'A total of 239 of the 308 patients (77·6%) were included in the modified intention-to-treat analysis']","['JNJ-9375', 'Apixaban', 'JNJ-9375 in doses ranging from 0.3 to 1.8 mg/kg or apixaban']","['major bleeds with JNJ-9375 or apixaban, and rates of any bleeding', 'symptomatic deep-vein thrombosis', 'composite of major, clinically relevant non-major, and minimal bleeding', 'incidence of venous thromboembolism (assessed by mandatory unilateral venography or confirmed symptomatic events', 'JNJ-9375 activity', 'Thrombin times']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0031545', 'cui_str': 'Venography'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}]",308.0,0.449783,"There were no major bleeds with JNJ-9375 or apixaban, and rates of any bleeding were similar with the highest and lowest JNJ-9375 doses.
","[{'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute and McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Annelise', 'Initials': 'A', 'LastName': 'Segers', 'Affiliation': 'ITREAS BV, Amsterdam, the Netherlands.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Roberts', 'Affiliation': 'McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Francis', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Michael Rud', 'Initials': 'MR', 'LastName': 'Lassen', 'Affiliation': 'Department of Orthopedics, Spine Section, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Fuji', 'Affiliation': 'Japan Community Healthcare Organization, Osaka Hospital, Osaka, Japan.'}, {'ForeName': 'Renée M', 'Initials': 'RM', 'LastName': 'Swaim', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Peters', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'DiBattiste', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Fisseha', 'Initials': 'F', 'LastName': 'Tesfaye', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strony', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14639']
142,32320797,Tiotropium Respimat Efficacy and Safety in Asthma: Relationship to Age.,"BACKGROUND


Data are limited on the differential response to long-acting bronchodilators in older versus younger adults with asthma.
OBJECTIVE


To determine whether the response to tiotropium Respimat differed in older versus younger patients with asthma.
METHODS


Post hoc analyses of 4 randomized, double-blind, placebo-controlled studies in adults with asthma were carried out. Two studies compared tiotropium Respimat 5 μg once daily with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β 2 -agonist (ie, severe asthma). The other 2 evaluated tiotropium Respimat 2.5 or 5 μg once daily, salmeterol 50 μg twice daily, or placebo, all added to medium-dose ICS (moderate asthma). Data were analyzed in 2 pools: (1) severe and (2) moderate asthma. Efficacy end points: trough and peak FEV 1 ; trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage, all at week 24. One set of analyses was performed with age as a continuous covariate; the second was conducted in categories less than 40, 40 to 60, and more than 60 years, with treatment-by-age subgroup interaction P values obtained. Safety was analyzed in age categories.
RESULTS


Across the age categories, treatment-by-age subgroup interaction P values for trough FEV 1  were .13 and .77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the 2 continuum analyses. The other end points (including safety) were also not impacted by age.
CONCLUSIONS


Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting β 2 -agonist therapy was effective and well tolerated in patients with asthma independent of age.",2020,"Across the age categories, treatment-by-age subgroup interaction p-values for trough FEV 1  were 0.13 and 0.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the two continuum analyses.","['patients with asthma independent of age', 'older versus younger patients with asthma', 'asthma', 'older versus younger adults with asthma', 'adults with asthma']","['tiotropium Respimat 5μg once-daily (QD) with placebo, both added to high-dose inhaled corticosteroid (ICS) plus long-acting β 2 -agonist (LABA', 'placebo', 'Tiotropium', 'tiotropium 2.5 or 5μg QD, salmeterol 50μg twice-daily, or placebo', 'tiotropium Respimat', 'LABA therapy']","['Efficacy endpoints: trough and peak forced expiratory volume in 1 second (FEV 1 ); trough forced vital capacity; Asthma Control Questionnaire total score and responder percentage', 'effective and well tolerated', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1.0,0.455248,"Across the age categories, treatment-by-age subgroup interaction p-values for trough FEV 1  were 0.13 and 0.77 for patients with severe and moderate asthma, respectively, not indicating significant impact of age on overall treatment effect, with this observation replicated in the two continuum analyses.","[{'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Doherty', 'Affiliation': 'University of Kentucky, Lexington, Ky. Electronic address: dedohe0@email.uky.edu.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Moroni-Zentgraf', 'Affiliation': 'Boehringer Ingelheim Pty. Ltd., Sydney, NSW, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Zaremba-Pechmann', 'Affiliation': 'Boehringer Ingelheim, Biberach an der Riss, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, The Netherlands.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.04.013']
143,32319039,Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review.,"Migraine is a debilitating neurologic disease. People who experience migraine can have substantial disability, impaired functioning and a decreased quality of life (QoL). Expert recommendations suggest that people with frequent migraine attacks or severe impairment related to attacks may benefit from preventive treatment. Despite these recommendations and the existence of evidence-based guidelines for the use of preventive medication, many people who are candidates for preventive therapies do not receive them. Thus, there is still a substantial unmet need for preventive migraine treatment. Calcitonin gene-related peptide (CGRP) has a demonstrated role in the pathophysiology of migraine. Galcanezumab-gnlm (galcanezumab) is a humanized monoclonal antibody that binds to the CGRP ligand and prevents binding to its receptor. It is administered as a once-monthly subcutaneous injection. The aim of this review is to present a comprehensive overview of the existing short- and long-term efficacy and safety data for galcanezumab in patients with migraine. Data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2 and REGAIN studies show that galcanezumab treatment for 3 or 6 months results in overall reduction in mean monthly migraine headache days in patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine. Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning. A 12-month open-label study demonstrated the continued efficacy of galcanezumab for up to 12 months. In all studies galcanezumab was well tolerated. In conclusion, data from pivotal studies show that galcanezumab may fulfill an unmet need in the treatment of patients with migraine who require preventive therapy.",2020,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","['patients with migraine', 'patients with episodic (EVOLVE-1 and EVOLVE-2) and chronic (REGAIN) migraine', 'patients with migraine who require preventive therapy', 'Migraine']","['Calcitonin gene-related peptide (CGRP', 'Migraine', 'Galcanezumab-gnlm (galcanezumab', 'galcanezumab', 'placebo', 'galcanezumab versus placebo', 'Galcanezumab']","['Efficacy and Safety', 'quality of life (QoL', 'level of disability', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C4731561', 'cui_str': 'galcanezumab-gnlm'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0581009,"Greater proportions of patients with episodic migraine receiving galcanezumab versus placebo demonstrated a ≥ 50%, ≥ 75% and 100% response to therapy and reported a lower level of disability and an improvement in functioning and QoL. Similarly, when compared with placebo, greater proportions of patients with chronic migraine treated with galcanezumab demonstrated a ≥ 50% and ≥ 75% response and reported improved functioning.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Martin', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Karen Hamrick', 'Initials': 'KH', 'LastName': 'Samaan', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA. karen.samaan@lilly.com.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Aurora', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Lilly USA, LLC, Indianapolis, IN, USA.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pallay', 'Affiliation': 'Department of Family Medicine, Mercer University School of Medicine, Savannah, GA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01319-9']
144,32315497,"Pharmacodynamic Effects of Topical Omiganan in Patients With Mild to Moderate Atopic Dermatitis in a Randomized, Placebo-Controlled, Phase II Trial.","Omiganan is an indolicidin analog with antimicrobial properties that could be beneficial for patients with atopic dermatitis. In this randomized, double-blind, placebo-controlled, phase II trial we explored the efficacy, pharmacodynamics, and safety of topical omiganan once daily in 36 patients with mild to moderate atomic dermatitis. Patients were randomized to apply topical omiganan 1%, omiganan 2.5%, or vehicle gel to one target lesion once daily for 28 consecutive days. Small but significant improvements in local objective SCORing Atopic Dematitis index and morning itch were observed in the omiganan 2.5% group compared with the vehicle gel group (-18.5%; 95% confidence interval, -32.9 to -1.0; P = 0.04; and -8.2; 95% confidence interval, -16.3 to -0.2; P = 0.05, respectively). A shift from lesional to nonlesional skin microbiota was observed in both omiganan treatment groups, in contrast to the vehicle group. Thus, treatment with topical omiganan improved dysbiosis in patients with mild to moderate atopic dermatitis, and small but statistically significant improvements in clinical scores were detected. Our findings warrant further exploration in future clinical trials.",2020,"Small but significant improvements of the local oSCORAD index and morning itch were observed in the omiganan 2.5% group compared to the vehicle gel group (-18.5%; 95%CI=-32.9,-1.0; p=0.04 and -8.2; 95%CI=-16.3,-0.2; p=0.05 respectively).","['36 patients with mild to moderate AD', 'patients with mild to moderate atopic dermatitis', 'patients with atopic dermatitis']","['omiganan 2.5% or vehicle gel', 'topical omiganan', 'placebo']","['local oSCORAD index and morning itch', 'lesional skin microbiota', 'Pharmacodynamic effects', 'clinical scores', 'efficacy, pharmacodynamics and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}]","[{'cui': 'C4550028', 'cui_str': 'Omiganan'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",36.0,0.310383,"Small but significant improvements of the local oSCORAD index and morning itch were observed in the omiganan 2.5% group compared to the vehicle gel group (-18.5%; 95%CI=-32.9,-1.0; p=0.04 and -8.2; 95%CI=-16.3,-0.2; p=0.05 respectively).","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Niemeyer-van der Kolk', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'van der Wall', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Geretta K', 'Initials': 'GK', 'LastName': 'Hogendoorn', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rianne', 'Initials': 'R', 'LastName': 'Rijneveld', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Luijten', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Dirk C J G', 'Initials': 'DCJG', 'LastName': 'van Alewijk', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, The Netherlands.'}, {'ForeName': 'Ellen H A', 'Initials': 'EHA', 'LastName': 'van den Munckhof', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, The Netherlands.'}, {'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'de Kam', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Feiss', 'Affiliation': 'Cutanea Life Sciences, Wayne, Pennsylvania, USA.'}, {'ForeName': 'Errol P', 'Initials': 'EP', 'LastName': 'Prens', 'Affiliation': 'Department of Dermatology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Martijn B A', 'Initials': 'MBA', 'LastName': 'van Doorn', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical and translational science,['10.1111/cts.12792']
145,32311911,Vascular effects of physical activity are not modified by short-term inhaled diesel exhaust: Results of a controlled human exposure study.,"BACKGROUND


The combined effects of physical activity and air pollution exposure on vascular function are insufficiently understood, particularly after the inhalation of a β 2 -agonist, a vasodilating agent.
OBJECTIVE


To assess the micro- and macrovascular response to physical activity after β 2 -agonist use while breathing diesel exhaust (DE) in individuals with exercise-induced bronchoconstriction.
METHODS


On four exposure visits, eighteen adults inhaled either 400 μg of the β 2 -agonist salbutamol or placebo before resting for 60 min, followed by a 30-min cycling bout. During rest and cycling, participants inhaled filtered air (FA) or DE (300 μg/m 3  of PM 2.5 ). Microvascular (central retinal arteriolar and venular equivalents, CRAE and CRVE, respectively) and macrovascular parameters (blood pressure (BP)) and heart rate (HR)) were assessed at baseline (T 1 ), 10 min (T 2 ) and 70 min (T 3 ) after cycling.
RESULTS


The cycling bout increased CRAE (T 2 -T 1  difference (95th % confidence interval): 4.88 μm (4.73, 5.00 μm), p < 0.001; T 3 -T 1  difference: 2.10 μm (1.62, 2.58 μm), p = 0.031) and CRVE (T 2 -T 1  difference: 3.78 μm (3.63, 3.92 μm), p < 0.001; T 3 -T 1  difference: 3.73 μm (3.63, 3.92 μm), p < 0.001). The exposure to DE had no effect on CRAE (FA-DE difference at T 2 : 0.46 μm (-0.02, 0.92 μm); p = 0.790; FA-DE difference at T 3 : 1.76 μm (1.36, 2.16 μm), p = 0.213) and CRVE (FA-DE difference at T 2 : 0.26 μm (-0.35, 0.88 μm), p = 0.906; FA-DE difference at T 3 : 0.55 μm (0.05, 1.06 μm), p = 0.750). Compared to T 1 , systolic BP was decreased at T 2  by 2.5 mmHg (2.8, 2.3 mmHg, p = 0.047), independent of inhaled exposure. Heart rate at T 2  was significantly increased by 3 bpm (2, 3 bpm, p = 0.025) after the DE-exposure when compared to FA.
DISCUSSION


Acute physical activity induces a vasodilatory response in the micro- and macrovasculature in healthy adults by increasing CRAE and CRVE, and by reducing systolic BP post exercise, despite breathing DE. The DE-associated increase in HR might be indicative of an increased sympathetic response to physical activity while breathing DE.",2020,"Heart rate at T 2  was significantly increased by 3 bpm (2, 3 bpm, p = 0.025) after the DE-exposure when compared to FA.
","['individuals with exercise-induced bronchoconstriction', 'healthy adults', 'eighteen adults inhaled either 400\xa0μg of the β 2']","['physical activity and air pollution exposure', 'agonist use while breathing diesel exhaust (DE', 'inhaled filtered air (FA) or DE', 'agonist salbutamol or placebo']","['Heart rate at T 2', 'CRVE', 'systolic BP', 'Microvascular (central retinal arteriolar and venular equivalents, CRAE and CRVE, respectively) and macrovascular parameters (blood pressure (BP)) and heart rate (HR', 'cycling bout increased CRAE ', 'vasodilatory response', 'CRAE (FA-DE difference']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0731566,"Heart rate at T 2  was significantly increased by 3 bpm (2, 3 bpm, p = 0.025) after the DE-exposure when compared to FA.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada. Electronic address: sarahkoch@alumni.ubc.ca.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Zelembaba', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tran', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Laeremans', 'Affiliation': 'Health Unit, Flemish Institute for Technological Research (VITO), Boeretang 200, 2400 Mol, Antwerp, Belgium; Centre for Environmental Sciences, Agoralaan building D, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hives', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Faculty of Medicine, University of British Columbia, 2329 West Mall, Vancouver, British Columbia, V6T 1Z4, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'De Boever', 'Affiliation': 'Health Unit, Flemish Institute for Technological Research (VITO), Boeretang 200, 2400 Mol, Antwerp, Belgium; Centre for Environmental Sciences, Agoralaan building D, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Michael Stephen', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada; Faculty of Medicine, University of British Columbia, 2329 West Mall, Vancouver, British Columbia, V6T 1Z4, Canada.'}]",Environmental research,['10.1016/j.envres.2020.109270']
146,32293641,Evaluation of Ixekizumab Treatment for Patients With Pityriasis Rubra Pilaris: A Single-Arm Trial.,"Importance


Pityriasis rubra pilaris is a rare and disabling cutaneous disease that is frequently recalcitrant to conventional therapies and appears to involve interleukin (IL)-17 overexpression.
Objective


To investigate the clinical response and safety of ixekizumab in treating pityriasis rubra pilaris.
Design, Setting, and Participants


Single-arm, investigator-initiated trial conducted in adult patients with moderate to severe pityriasis rubra pilaris at a single-center academic university from June 2018 to January 2020. A total of 41 patients were screened, 12 were enrolled, and 11 completed the full duration of therapy. A referred, consecutive sample was used during participant selection. The treatment period and primary outcome occurred over 24 weeks with additional patient follow-up through 36 weeks.
Intervention


Subcutaneous administration of ixekizumab, a humanized IgG4 antibody that binds IL-17A, at the US Food and Drug Administration-approved dosing schedule for treatment of psoriasis for 24 weeks.
Main Outcomes and Measures


The primary outcome was the mean change in Psoriasis Area and Severity Index at 24 weeks. Secondary outcomes included change in affected body surface area, quality of life, induction of sustained remission, and association of improvement with CARD14 genetic variations and cutaneous cytokine expression.
Results


A total of 12 white patients (mean [SD] age, 49.8 [15.1] years; 8 male [67%]) were enrolled between June 2018 and April 2019, with 11 completing the full course of intervention. The mean (SEM) improvements in Psoriasis Area and Severity Index, affected body surface area, and Dermatology Life Quality Index were 15.2 (2.1) (P < .0001), 29.8% (9.3%) (P = .009), and 9.5 (2.5) (P = .004), respectively. The 4 participants with the most improvement in Psoriasis Area and Severity Index at week 24 stayed in remission at week 36 (defined as lack of increase in Psoriasis Area and Severity Index from week 24 through week 36), off therapy. Relative dermal IL-17A expression decreased by a 1.9 log-fold change. No participants had known pathogenic CARD14 variations. There were no serious adverse events.
Conclusions and Relevance


In this single-armed trial, ixekizumab was associated with reduced clinical signs and symptoms of pityriasis rubra pilaris in a subset of patients, including those in whom other systemic therapies have failed.
Trial Registration


ClinicalTrials.gov Identifier: NCT03485976.",2020,"The mean (SEM) improvements in Psoriasis Area and Severity Index, affected body surface area, and Dermatology Life Quality Index were 15.2 (2.1) (P < .0001), 29.8% (9.3%) (P = .009), and 9.5 (2.5) (P = .004), respectively.","['Patients With Pityriasis Rubra Pilaris', 'pityriasis rubra pilaris', 'A total of 41 patients were screened, 12 were enrolled, and 11 completed the full duration of therapy', '12 white patients (mean [SD] age', '49.8 [15.1] years; 8 male [67%]) were enrolled between June 2018 and April 2019, with 11 completing the full course of intervention', 'Pityriasis rubra pilaris', 'adult patients with moderate to severe pityriasis rubra pilaris at a single-center academic university from June 2018 to January 2020']","['ixekizumab', 'Ixekizumab']","['Relative dermal IL-17A expression', 'Psoriasis Area and Severity Index', 'mean change in Psoriasis Area and Severity Index', 'clinical signs and symptoms of pityriasis rubra pilaris', 'change in affected body surface area, quality of life, induction of sustained remission, and association of improvement with CARD14 genetic variations and cutaneous cytokine expression', 'mean (SEM) improvements in Psoriasis Area and Severity Index, affected body surface area, and Dermatology Life Quality Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}]",12.0,0.122501,"The mean (SEM) improvements in Psoriasis Area and Severity Index, affected body surface area, and Dermatology Life Quality Index were 15.2 (2.1) (P < .0001), 29.8% (9.3%) (P = .009), and 9.5 (2.5) (P = .004), respectively.","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Haynes', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Strunck', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Topham', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Alex G', 'Initials': 'AG', 'LastName': 'Ortega-Loayza', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Kent', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Pamela B', 'Initials': 'PB', 'LastName': 'Cassidy', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'Department of Dermatology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Choate', 'Affiliation': 'Department of Dermatology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Yuangang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Teri M', 'Initials': 'TM', 'LastName': 'Greiling', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, Oregon.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.0932']
147,32293657,Negative Pressure Wound Therapy vs Conventional Wound Treatment in Subcutaneous Abdominal Wound Healing Impairment: The SAWHI Randomized Clinical Trial.,"Importance


Negative pressure wound therapy (NPWT) is an established treatment option, but there is no evidence of benefit for subcutaneous abdominal wound healing impairment (SAWHI).
Objective


To evaluate the effectiveness and safety of NPWT for SAWHI after surgery in clinical practice.
Design, Setting, and Participants


The multicenter, multinational, observer-blinded, randomized clinical SAWHI study enrolled patients between August 2, 2011, and January 31, 2018. The last follow-up date was June 11, 2018. The trial included 34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands, and 539 consecutive, compliant adult patients with SAWHI after surgery without fascia dehiscence were randomly assigned to the treatment arms in a 1:1 ratio stratified by study site and wound size using a centralized web-based tool. A total of 507 study participants (NPWT, 256; CWT, 251) were assessed for the primary end point in the modified intention-to-treat (ITT) population.
Interventions


Negative pressure wound therapy and conventional wound treatment (CWT).
Main Outcomes and Measures


The primary outcome was time until wound closure (delayed primary closure or by secondary intention) within 42 days. Safety analysis comprised the adverse events (AEs). Secondary outcomes included wound closure rate, quality of life (SF-36), pain, and patient satisfaction.
Results


Of the 507 study participants included in the modified ITT population, 287 were men (56.6%) (NPWT, 155 [60.5%] and CWT, 132 [52.6%]) and 220 were women (43.4%) (NPWT, 101 [39.5%] and CWT 119 [47.4%]). The median (IQR) age of the participants was 66 (18) years in the NPWT arm and 66 (20) years in the CWT arm. Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days) (difference, 3.0 days; 95% CI 1.6-4.4; P < .001). Wound closure rate within 42 days was significantly higher with NPWT (35.9%) than with CWT (21.5%) (difference, 14.4%; 95% CI, 6.6%-22.2%; P < .001). In the therapy-compliant population, excluding study participants with unauthorized treatment changes (NPWT, 22; CWT, 50), the risk for wound-related AEs was higher in the NPWT arm (risk ratio, 1.51; 95% CI, 0.99-2.35).
Conclusions and Relevance


Negative pressure wound therapy is an effective treatment option for SAWHI after surgery; however, it causes more wound-related AEs.
Trial Registration


ClinicalTrials.gov Identifier: NCT01528033.",2020,Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days),"['34 abdominal surgical departments of hospitals in Germany, Belgium, and the Netherlands, and 539 consecutive, compliant adult patients with SAWHI after surgery without fascia dehiscence', 'A total of 507 study participants (NPWT, 256; CWT, 251) were assessed for the primary end point in the modified intention-to-treat (ITT) population', '287 were men (56.6%) (NPWT, 155 [60.5%] and CWT, 132 [52.6%]) and 220 were women (43.4', 'enrolled patients between August 2, 2011, and January 31, 2018', 'Subcutaneous Abdominal Wound Healing Impairment', '507 study participants included in the modified ITT population']","['Negative Pressure Wound Therapy vs Conventional Wound Treatment', 'NPWT', 'Interventions\n\n\nNegative pressure wound therapy and conventional wound treatment (CWT', 'Negative pressure wound therapy (NPWT']","['Mean time to wound closure', 'risk for wound-related AEs', 'Wound closure rate', 'time until wound closure (delayed primary closure or by secondary intention', 'wound closure rate, quality of life (SF-36), pain, and patient satisfaction']","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0587503', 'cui_str': 'Surgical department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4510895', 'cui_str': 'Wound of abdomen'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1272654', 'cui_str': 'Wound care management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",34.0,0.27563,Mean time to wound closure was significantly shorter in the NPWT arm (36.1 days) than in the CWT arm (39.1 days),"[{'ForeName': 'Dörthe', 'Initials': 'D', 'LastName': 'Seidel', 'Affiliation': 'Institute for Research in Operative Medicine, University of Witten/Herdecke, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Diedrich', 'Affiliation': 'Department of General Surgery, Visceral, Thoracic and Vascular Surgery, Greifswald University Hospital, Greifswald, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Herrle', 'Affiliation': 'Department of Surgery, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Thielemann', 'Affiliation': 'Department of General and Abdominal Surgery, Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Marusch', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Ernst von Bergmann gemeinnützige GmbH, Potsdam, Germany.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Schirren', 'Affiliation': 'Department and Polyclinic of Surgery, Hospital Rechts der Isar -Technical University of Munich, München, Germany.'}, {'ForeName': 'Recca', 'Initials': 'R', 'LastName': 'Talaulicar', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gehrig', 'Affiliation': 'Department of General and Visceral Surgery, GRN Klinik Sinsheim, Sinsheim, Germany.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Lehwald-Tywuschik', 'Affiliation': 'Department of Surgery (A), Hospital of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Glanemann', 'Affiliation': 'Department of General, Visceral, Vascular and Pediatric Surgery, Saarland University, Homburg, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Bunse', 'Affiliation': 'Department of General and Visceral Surgery, Sana Klinikum Lichtenberg, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hüttemann', 'Affiliation': 'Department of General and Visceral Surgery, Evangelisches Krankenhaus Oberhausen, Oberhausen, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Braumann', 'Affiliation': 'Department of General and Visceral Surgery, St Josef-Hospital Bochum, Bochum, Germany.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Heizmann', 'Affiliation': 'Department of General, Visceral und Thoracic Surgery, Agaplesion Diakonieklinikum Rotenburg gemeinnützige GmbH, Rotenburg (Wümme), Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miserez', 'Affiliation': 'Department of Abdominal Surgery, University Hospitals Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krönert', 'Affiliation': 'Center for Vascular Medicine, Department of Vascular Surgery, Thüringen Kliniken Georgius Agricola, Saalfeld, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Gretschel', 'Affiliation': 'Brandenburg Medical School,Department of General and Visceral Surgery, University Hospital Neuruppin, Neuruppin, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Lefering', 'Affiliation': 'Institute for Research in Operative Medicine, University of Witten/Herdecke, Cologne, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2020.0414']
148,32320027,"Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials.","Importance


Acne is a common, multifactorial skin condition, and treatments with novel mechanisms have been elusive.
Objective


To assess the safety and efficacy of clascoterone cream, 1%, a novel topical androgen receptor inhibitor, in 2 phase 3 randomized clinical trials (CB-03-01/25 and CB-03-01/26).
Design, Setting, and Participants


Two identical, multicenter, randomized, vehicle-controlled, double-blind, phase 3 studies conducted from November 2015 to April 2018 evaluated the efficacy and safety of use of clascoterone cream, 1%, in males and nonpregnant females 9 years and older with moderate or severe facial acne as scored on the Investigator's Global Assessment scale. Participants were enrolled if they had 30 to 75 inflammatory lesions and 30 to 100 noninflammatory lesions.
Interventions


Patients were randomized to treatment with clascoterone cream, 1%, or vehicle cream and applied approximately 1 g to the whole face twice daily for 12 weeks.
Main Outcomes and Measures


Treatment success was defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline and absolute change from baseline in noninflammatory and inflammatory lesion counts at week 12. Safety measures included adverse event frequency and severity.
Results


A total of 1440 patients were randomzied in 2 studies. In CB-03-01/25, 353 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-58] years; 221 [62.6%] female), and 355 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [9-50] years; 215 (60.6%) female); in CB-03-01/26, 369 participants were randomized to treatment with clascoterone cream, 1% (median [range] age, 18.0 [10-50] years; 243 [65.9%] female), and 363 participants were randomized to treatment with vehicle cream (median [range] age, 18.0 [range, 11-42] years; 221 [60.9%] female). At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) vs 9.0% and 6.5% with vehicle, respectively. At week 12, in both CB-03-01/25 and CB-03-01/26, treatment with clascoterone cream, 1%, resulted in a significant reduction in absolute noninflammatory lesions from baseline to -19.4 (point estimate difference, -6.4; 95% CI, -10.3 to -2.6; P < .001) and -19.4 (point estimate difference, -8.6; 95% CI, -12.3 to -4.9; P < .001) vs -13.0 and -10.8 with vehicle, respectively, as well as a reduction in inflammatory lesions from baseline to -19.3 (point estimate difference, -3.8; 95% CI, -6.4 to -1.3; P < .001) and -20.0 (point estimate difference, -7.4; 95% CI, -9.8 to -5.1; P < .001) vs -15.5 and -12.6 with vehicle, respectively. Adverse events rates were low and mostly mild; the predominant local skin reaction was trace or mild erythema.
Conclusions and Relevance


Use of clascoterone cream, 1%, for acne treatment appears to demonstrate favorable efficacy and safety with low adverse event rates.
Trial Registration


ClinicalTrials.gov Identifiers: NCT02608450 and NCT02608476.",2020,"At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) vs 9.0% and 6.5% with vehicle, respectively.","['Participants were enrolled if they had 30 to 75 inflammatory lesions and 30 to 100 noninflammatory lesions', '1440 patients were randomzied in 2 studies', ' 1% (median [range] age, 18.0 [10-50] years; 243 [65.9%] female), and 363 participants', ""males and nonpregnant females 9 years and older with moderate or severe facial acne as scored on the Investigator's Global Assessment scale"", ' 1% (median [range] age, 18.0 [10-58] years; 221 [62.6%] female), and 355 participants', 'Patients With Facial Acne', 'median [range] age, 18.0 [9-50] years; 215 (60.6%) female); in CB-03-01/26, 369 participants', '353 participants']","['Topical Clascoterone Cream', 'clascoterone cream, 1%, or vehicle cream', 'clascoterone cream', 'vehicle cream']","['Efficacy and Safety', 'safety and efficacy', 'absolute noninflammatory lesions', 'Adverse events rates', ""Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline and absolute change from baseline in noninflammatory and inflammatory lesion counts"", 'adverse event frequency and severity', 'inflammatory lesions']","[{'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C4709308', 'cui_str': '215'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",1440.0,0.417401,"At week 12, treatment success rates in CB-03-01/25 and CB-03-01/26 with clascoterone cream, 1%, were 18.4% (point estimate, 2.3; 95% CI, 1.4-3.8; P < .001) and 20.3% (point estimate, 3.7; 95% CI, 2.2-6.3; P < .001) vs 9.0% and 6.5% with vehicle, respectively.","[{'ForeName': 'Adelaide', 'Initials': 'A', 'LastName': 'Hebert', 'Affiliation': 'McGovern Medical School, The University of Texas Health Science Center, Houston.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Thiboutot', 'Affiliation': 'College of Medicine, The Pennsylvania State University, Hershey.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Cartwright', 'Affiliation': 'Cassiopea Inc, San Diego, California.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Gerloni', 'Affiliation': 'Cassiopea SpA, Lainate, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fragasso', 'Affiliation': 'Cassiopea SpA, Lainate, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Mazzetti', 'Affiliation': 'Cassiopea SpA, Lainate, Italy.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.0465']
149,32317591,Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019.,"OBJECTIVES


Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU. This study aimed to describe specific pathophysiological characteristics of acute respiratory distress syndrome from coronavirus disease 2019.
DESIGN


Prospective crossover physiologic study.
SETTING


ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019.
PATIENTS


Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019.
INTERVENTIONS


We performed a two-step positive end-expiratory pressure trial with change of 10 cm H2O in random order.
MEASUREMENTS AND MAIN RESULTS


At each positive end-expiratory pressure level, we assessed arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography. Potential for lung recruitment was assessed by the recently described recruitment to inflation ratio. In a subgroup of seven paralyzed patients, we also measured ventilation-perfusion mismatch at lower positive end-expiratory pressure by electrical impedance tomography. At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure. Oxygenation and ventilation inhomogeneity improved but arterial CO2 increased despite unchanged respiratory rate and tidal volume. The recruitment to inflation ratio presented median value higher than previously reported in acute respiratory distress syndrome patients but with large variability (median, 0.79 [0.53-1.08]; range, 0.16-1.40). The FIO2 needed to obtain viable oxygenation at lower positive end-expiratory pressure was significantly correlated with the recruitment to inflation ratio (r = 0.603; p = 0.05). The ventilation-perfusion mismatch was elevated (median, 34% [32-45%] of lung units) and, in six out of seven patients, ventilated nonperfused units represented a much larger proportion than perfused nonventilated ones.
CONCLUSIONS


In patients with acute respiratory distress syndrome from coronavirus disease 2019, potential for lung recruitment presents large variability, while elevated dead space fraction may be a specific pathophysiological trait. These findings may guide selection of personalized mechanical ventilation settings.",2020,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","['Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019', 'patients with acute respiratory distress syndrome', 'acute respiratory distress syndrome from coronavirus disease 2019', 'ICU of a university-affiliated hospital from northern Italy dedicated to care of patients with confirmed diagnosis of coronavirus disease 2019', 'Ten intubated patients with acute respiratory distress syndrome and confirmed diagnosis of coronavirus disease 2019', 'Severe cases of coronavirus disease 2019 develop the acute respiratory distress syndrome, requiring admission to the ICU']",['Lung Recruitment and Ventilation-Perfusion Mismatch'],"['arterial blood gases, respiratory mechanics, ventilation inhomogeneity, and potential for lung recruitment by electrical impedance tomography', 'respiratory rate and tidal volume', 'ventilation-perfusion mismatch']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C2721740', 'cui_str': 'Ventilation perfusion mismatch'}]",10.0,0.127794,"At higher positive end-expiratory pressure, respiratory mechanics did not change significantly: compliance remained relatively high with low driving pressure.","[{'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Scotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Colussi', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Crotti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tubiolo', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tagliabue', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zanella', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]",Critical care medicine,['10.1097/CCM.0000000000004386']
150,32312223,Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis.,"Background and Purpose- The PCSK9 (proprotein convertase subtilisin-kexin type 9) monoclonal antibody evolocumab lowered LDL (low-density lipoprotein) cholesterol by 59% to 0.8 (0.5-1.2) mmol/L and significantly reduced major vascular events in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk). Herein, we report the results of a prespecified analysis of cerebrovascular events in the overall trial population and in patients stratified by prior stroke. Methods- FOURIER was a randomized, double-blind trial comparing evolocumab versus placebo in patients with established atherosclerosis, additional risk factors, and LDL cholesterol levels ≥1.8 (or non-HDL [high-density lipoprotein] ≥2.6 mmol/L) on statin therapy. The median follow-up was 2.2 years. We analyzed the efficacy of evolocumab to reduce overall stroke and stroke subtypes, as well as the primary cardiovascular composite end point by subgroups according to a history of stroke. Results- Among the 27 564 patients, 469 (1.7%) experienced a total of 503 strokes of which 421 (84%) were ischemic. Prior ischemic stroke, diabetes mellitus, elevated CRP (C-reactive protein), history of heart failure, older age, nonwhite race, peripheral arterial disease, and renal insufficiency were independent predictors of stroke. Evolocumab significantly reduced all stroke (1.5% versus 1.9%; hazard ratio, 0.79 [95% CI, 0.66-0.95];  P =0.01) and ischemic stroke (1.2% versus 1.6%; hazard ratio, 0.75 [95% CI, 0.62-0.92];  P =0.005), with no difference in hemorrhagic stroke (0.21% versus 0.18%; hazard ratio, 1.16 [95% CI, 0.68-1.98];  P =0.59). These findings were consistent across subgroups, including among the 5337 patients (19%) with prior ischemic stroke in whom the hazard ratios (95% CIs) were 0.85 (0.72-1.00) for the cardiovascular composite, 0.90 (0.68-1.19) for all stroke, and 0.92 (0.68-1.25) for ischemic stroke ( P  interactions, 0.91, 0.22, and 0.09, respectively, compared with patients without a prior ischemic stroke). Conclusions- Inhibition of PCSK9 with evolocumab added to statin in patients with established atherosclerosis reduced ischemic stroke and cardiovascular events in the total population and in key subgroups, including those with prior ischemic stroke. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT01764633.",2020,"Evolocumab significantly reduced all stroke (1.5% versus 1.9%; hazard ratio, 0.79 [95% CI, 0.66-0.95];  P =0.01) and ischemic stroke (1.2% versus 1.6%; hazard ratio, 0.75 [95% CI, 0.62-0.92];  P =0.005), with no difference in hemorrhagic stroke (0.21% versus 0.18%; hazard ratio, 1.16 [95% CI, 0.68-1.98];  P =0.59).","['27 564 patients, 469 (1.7%) experienced a total of 503 strokes of which 421 (84%) were ischemic', 'High-Risk Patients With Stable Atherosclerosis', 'patients stratified by prior stroke', 'patients with established atherosclerosis reduced', 'Subjects with Elevated Risk', 'patients with established atherosclerosis, additional risk factors, and LDL cholesterol levels ≥1.8 (or non-HDL [high-density lipoprotein] ≥2.6 mmol/L) on statin therapy']","['PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9', 'evolocumab', 'Methods', 'evolocumab versus placebo', ' and Purpose', 'PCSK9 with evolocumab added to statin', 'Inhibitor Evolocumab Added to Statin']","['hemorrhagic stroke', 'stroke', 'ischemic stroke', 'ischemic stroke and cardiovascular events', 'Prior ischemic stroke, diabetes mellitus, elevated CRP (C-reactive protein), history of heart failure, older age, nonwhite race, peripheral arterial disease, and renal insufficiency', 'major vascular events', 'LDL (low-density lipoprotein) cholesterol', 'Stroke Prevention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C1426592', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 gene'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}]",27564.0,0.379903,"Evolocumab significantly reduced all stroke (1.5% versus 1.9%; hazard ratio, 0.79 [95% CI, 0.66-0.95];  P =0.01) and ischemic stroke (1.2% versus 1.6%; hazard ratio, 0.75 [95% CI, 0.62-0.92];  P =0.005), with no difference in hemorrhagic stroke (0.21% versus 0.18%; hazard ratio, 1.16 [95% CI, 0.68-1.98];  P =0.59).","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': 'Terje R', 'Initials': 'TR', 'LastName': 'Pedersen', 'Affiliation': 'Oslo Universitetssykehus HF, Endocrinology-Morbid Obesity and Preventive Medicine, Norway (T.R.P.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine at UCLA, Los Angeles, CA (J.L.S.).'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Sever', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom (P.S.S.).'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Keech', 'Affiliation': 'Sydney Medical School, National Health and Medical Research Council Clinical Trials Centre, Australia (A.C.K.).'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Narimon', 'Initials': 'N', 'LastName': 'Honarpour', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Huei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Lira Pineda', 'Affiliation': 'Amgen, Inc, Global Development, Thousand Oaks, CA (S.M.W., N.H., H.W., A.L.P.).'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""From the TIMI (Thrombolysis in Myocardial Infarction) Study Group, Cardiovascular Medicine, Brigham and Women's Hospital, Boston, MA (R.P.G., E.A.B., S.A.M., M.S.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027759']
151,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


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


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


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


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
152,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


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


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


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


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
153,32314015,Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial.,"PURPOSE


This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).
METHODS


We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.
RESULTS


Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1; p < 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups.
CONCLUSION


Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.",2020,"Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25).","['women delivered only by elective cesarean section', '200 women aged ≥\u200918\xa0years who previously delivered by elective CD willing to receive LNG-IUS', 'family planning clinic of Cairo University hospitals from August 2019 to January 2020', 'women undergoing elective cesarean delivery (CD']","['vaginal dinoprostone or placebo', 'Dinoprostone', 'levonorgestrel-releasing intrauterine system insertion', 'vaginal dinoprostone', 'placebo', 'dinoprostone 3\xa0mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion', 'dinoprostone']","['Adverse events', 'Satisfaction score', 'tolerable side effects', 'pain during LNG-IUS insertion', 'pain during insertion and 30\xa0min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects', 'efficacy and safety', 'pain', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1131356', 'cui_str': 'Dinoprostone 3 MG'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",200.0,0.845057,"Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6; p = 0.25).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Abdelhakim', 'Affiliation': 'Department of Histology, Faculty of Medicine, Kasr-Alainy, Cairo University, Cairo, Egypt. ahmed.m.rohei@students.kasralainy.edu.eg.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Omneya M', 'Initials': 'OM', 'LastName': 'Osman', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05543-0']
154,29332989,Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial.,"This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans ( N  = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions.",2016,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"['Veterans ( N  = 11', 'Combat-Related PTSD']","['Cognitive Processing Therapy (CPT', 'individual CPT, or individual CPT in conjunction with individual art therapy', 'Art Therapy and Cognitive Processing Therapy']",['PTSD Checklist-Military Version and Beck Depression Inventory-II scores'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}]",11.0,0.0332411,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Art therapist at the University Neuro-psychiatric Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Decker', 'Affiliation': 'Staff psychiatrist at the Hampton VA Medical Center, Hampton, VA, and faculty member in the Department of Psychiatry at Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kruk', 'Affiliation': 'Community faculty.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Deaver', 'Affiliation': 'Professor in the Graduate Art Therapy and Counseling Professions Program, Eastern Virginia Medical School.'}]",Art therapy : journal of the American Art Therapy Association,['10.1080/07421656.2016.1226643']
155,32309974,Trialing the feasibility of a critical time intervention for youth transitioning out of homelessness.,"Little is known regarding the specific types of service models and collaborations that are necessary to support diverse populations of youth in transition out of homelessness. Transitional supports addressing the complex needs of this population are needed to stabilize the array of housing arrangements that youth access. This study was a pilot randomized controlled trial of one such critical time intervention, called the Housing Outreach Program-Collaboration (HOP-C). HOP-C is a multicomponent, multidisciplinary intervention that provides 6 months of mental health and peer support, along with transitional case management to youth who have transitioned into some form of stable housing out of homelessness. In this trial, 65 youth were randomized to receive HOP-C plus treatment as usual or transitional case management plus treatment as usual. Outcome assessments were completed by 30 treatment and 28 control participants. The findings suggest that this intervention is feasible with mental health, employment or education, and housing metrics favoring HOP-C with odds ratios ranging from 2.28 to 3.18 and better subjective housing stability. Other indicators showed less change. HOP-C appears feasible and should be tested in a fully powered trial, providing the intervention for a duration longer than 6 months. Overall, these data suggest the potential benefit in fostering city-level, multidisciplinary teams sourced from several organizations to support youth transitioning out of homelessness. Pragmatic trial method considerations for this population are also addressed as are the ethical considerations pertinent to engaging highly marginalized youth in clinical trials. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"This study was a pilot randomized controlled trial of one such critical time intervention, called the Housing Outreach Program-Collaboration (HOP-C).","['youth transitioning out of homelessness', '65 youth']","['critical time intervention', 'HOP-C plus treatment as usual or transitional case management plus treatment as usual']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085971', 'cui_str': 'Case management'}]",[],65.0,0.084008,"This study was a pilot randomized controlled trial of one such critical time intervention, called the Housing Outreach Program-Collaboration (HOP-C).","[{'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Kidd', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Vitopoulos', 'Affiliation': 'Centre for Addiction and Mental Health.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Frederick', 'Affiliation': 'Faculty of Social Sciences and Humanities.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Leon', 'Affiliation': 'Wellesley Institute.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Centre for Addiction and Mental Health.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mushquash', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'McKenzie', 'Affiliation': 'Department of Psychiatry.'}]",The American journal of orthopsychiatry,['10.1037/ort0000454']
156,32310288,Effect of a Mammography Screening Decision Aid for Women 75 Years and Older: A Cluster Randomized Clinical Trial.,"Importance


Guidelines recommend that women 75 years and older be informed of the benefits and harms of mammography before screening.
Objective


To test the effects of receipt of a paper-based mammography screening decision aid (DA) for women 75 years and older on their screening decisions.
Design, Setting, and Participants


A cluster randomized clinical trial with clinician as the unit of randomization. All analyses were completed on an intent-to-treat basis. The setting was 11 primary care practices in Massachusetts or North Carolina. Of 1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated. A research assistant (RA) administered a previsit questionnaire on each participant's health, breast cancer risk factors, sociodemographic characteristics, and screening intentions. After the visit, the RA administered a postvisit questionnaire on screening intentions and knowledge.
Interventions


Receipt of the DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit.
Main Outcomes and Measures


Participants were followed up for 18 months for receipt of mammography screening (primary outcome). To examine the effects of the DA, marginal logistic regression models were fit using generalized estimating equations to allow for clustering by PCP. Adjusted probabilities and risk differences were estimated to account for clustering by PCP.
Results


Of 546 women in the study, 283 (51.8%) received the DA. Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy. After 18 months, 9.1% (95% CI, 1.2%-16.9%) fewer women in the DA arm than in the control arm had undergone mammography screening (51.3% vs 60.4%; adjusted risk ratio, 0.84; 95% CI, 0.75-0.95; P = .006). Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]). Almost all women in the DA arm (94.9%) would recommend the DA.
Conclusions and Relevance


Providing women 75 years and older with a mammography screening DA before a PCP visit helps them make more informed screening decisions and leads to fewer women choosing to be screened, suggesting that the DA may help reduce overscreening.
Trial Registration


ClinicalTrials.gov Identifier: NCT02198690.",2020,"Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]).","['women 75 years and older on their screening decisions', '546 women in the study, 283 (51.8%) received the DA', 'Women 75 Years and Older', '1247 eligible women reached, 546 aged 75 to 89 years without breast cancer or dementia who had a mammogram within 24 months but not within 6 months and saw 1 of 137 clinicians (herein referred to as PCPs) from November 3, 2014, to January 26, 2017, participated', 'Patients in each arm were well matched; their mean (SD) age was 79.8 (3.7) years, 428 (78.4%) were non-Hispanic white, 321 (of 543 [59.1%]) had completed college, and 192 (35.2%) had less than a 10-year life expectancy', '11 primary care practices in Massachusetts or North Carolina', 'women 75 years and older', 'women 75 years and older with a mammography screening DA before a PCP visit']","['Mammography Screening Decision Aid', 'DA (DA arm) or a home safety (HS) pamphlet (control arm) before a PCP visit', 'paper-based mammography screening decision aid (DA']","['benefits and harms of screening', 'rate their screening intentions lower from previsit to postvisit', 'undergone mammography screening', 'screening intentions and knowledge']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C4517775', 'cui_str': '428'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0203028', 'cui_str': 'Screening mammography'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",1247.0,0.102056,"Women in the DA arm were more likely than those in the control arm to rate their screening intentions lower from previsit to postvisit (69 of 283 [adjusted %, 24.5%] vs 47 of 263 [adjusted %, 15.3%]), to be more knowledgeable about the benefits and harms of screening (86 [adjusted %, 25.5%] vs 32 [adjusted %, 11.7%]), and to have a documented discussion about mammography with their PCP (146 [adjusted %, 47.4%] vs 111 [adjusted %, 38.9%]).","[{'ForeName': 'Mara A', 'Initials': 'MA', 'LastName': 'Schonberg', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Kistler', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Adlin', 'Initials': 'A', 'LastName': 'Pinheiro', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Alicia R', 'Initials': 'AR', 'LastName': 'Jacobson', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Gianna M', 'Initials': 'GM', 'LastName': 'Aliberti', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Karamourtopoulos', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': 'Ariadne Labs, Boston, Massachusetts.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Christina C', 'Initials': 'CC', 'LastName': 'Wee', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Department of Population Health, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Nekhlyudov', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Marcantonio', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Hamel', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Division of General Medicine, Department of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0440']
157,32286322,"Colloidal Silicon Dioxide in Tablet form (Carbowhite) Efficacy in Patients with Acute Diarrhea: Results of Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study.","The acute diarrhea is a wide-spread disease. The prescription of enterosorbents is appropriate as a primary measure for the treatment of the acute diarrhea for effective prevention of the fluid and electrolyte loss, as well as method for symptom relief of the attack of the disease. Aim of the study - the antidiarrheal efficacy and safety study of high-dispersion silicon dioxide enterosorbent in tablet dosage form in patients with acute diarrhea. This was randomized, double-blind, placebo-controlled, 4-center study. Acute diarrhea was defined as three and more episodes of watery stool per day either during 48 hours or less before study entry in the patients having normal stool recently. It has been postulated that symptoms and signs of acute diarrhea have to be caused by direct infection of the gastrointestinal tract and did not associated with moderate-to-severe systemic states. 144 patients with established acute diarrhea were randomized into treatment group (enterosorbent ""Carbowhite"", n = 120) or placebo group. Date collection including severity diarrhea, systemic symptoms was performed at baseline and daily during 7 days. Stool examination and serological assay were performed at baseline. The primary end points were declared as time to complete recovery from acute diarrhea. It has been found that the use of the siliceous enterosorbent (""Carbowhite"") allowed to reduce (p < 0.001) the treatment period averagely for 0.9 days (95% confidence interval 0.5-1.2 days) in comparison with placebo. Data of safety monitoring has revealed that both patient groups had negative stool culture, while initiation of antibiotic treatment was run more frequently in placebo group (8.3%) compared to investigational product group (4.1%, P = 0.044). The siliceous enterosorbent ""Carbowhite"" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.",2020,"The siliceous enterosorbent ""Carbowhite"" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.","['144 patients with established acute diarrhea', 'patients with acute diarrhea', 'Patients with Acute Diarrhea']","['treatment group (enterosorbent ""Carbowhite"", n\u2009=\u2009120) or placebo', 'high-dispersion silicon dioxide enterosorbent', 'placebo', 'Colloidal Silicon Dioxide', 'Placebo']","['Stool examination and serological assay', 'Acute diarrhea', 'severity diarrhea, systemic symptoms', 'time to complete recovery from acute diarrhea', 'negative stool culture']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0982384', 'cui_str': 'silicon dioxide, colloidal'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0430414', 'cui_str': 'Stool culture'}]",144.0,0.375585,"The siliceous enterosorbent ""Carbowhite"" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Tieroshyn', 'Affiliation': 'Kharkiv National Medical University, Kharkiv, Ukraine. v.a.teryshin@gmail.com.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Moroz', 'Affiliation': 'Vinnytsya National Medical University named after M. I. Pirogov, Vinnytsya, Ukraine.'}, {'ForeName': 'Oleksandra', 'Initials': 'O', 'LastName': 'Prishliak', 'Affiliation': 'Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Shostakovich-Koretska', 'Affiliation': 'Dnipro State Medical Academy, Dnipro, Ukraine.'}, {'ForeName': 'Oksana', 'Initials': 'O', 'LastName': 'Kruglova', 'Affiliation': 'Lugansk State Medical University, Rubizhne, Ukraine.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Gordienko', 'Affiliation': 'Kiev City Clinical Hospital No.9, Kiev, Ukraine.'}]",Scientific reports,['10.1038/s41598-020-62386-0']
158,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
159,32014649,An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters!,"BACKGROUND


Results from human experimental studies investigating possible effects of radiofrequency electromagnetic fields (RF-EMF) on sleep are heterogeneous. So far, there is no study on possible sex-differences in RF-EMF effects.
OBJECTIVES


The present study aimed at analyzing differences in RF-EMF effects on the macrostructure of sleep between healthy elderly males and females.
METHODS


With a double-blind, randomized, sham-controlled cross-over design effects of two RF-EMF exposures (GSM900 and TETRA) on sleep were investigated in samples of 30 elderly healthy male and 30 healthy elderly female volunteers. Participants underwent each of the three exposure conditions on three occassions following an individually randomized order resulting in a total of nine study nights per participant. Exposure was delivered for 30 min prior to sleep and for the whole night (7.5 h) by a head worn antenna specifically designed for the projects. The peak spatial absorption rate averaged over time in head tissues (psSAR10g) was 6 W/kg for TETRA and 2 W/kg for GSM900. Thirty variables characterising the macrostructure of sleep and arousals as well as four subjective sleep variables were considered for statistical analyses.
RESULTS


Multivariate analyses revealed that exposure to GSM900 and/or TETRA resulted in a significant reduction in arousals, a shorter latency to sleep stage N3, and a shorter self-reported time awake after sleep in both males and females. Exposure effects depending on sex (significant interactions) were observed. Latency to sleep stage R was shorter in females and tended to be longer in males under both exposures. Latency to stage N3 was shorter in females under TETRA exposure and almost not affected in males. The time awake within the sleep period under TETRA exposure was shorter in females and only slightly longer in males. Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males. Finally, the number of awakenings was lower only in females and tended to be higher in males under GSM exposure.
DISCUSSION


With regard to RF-EMF effects on human sleep it seems that gender matters since GSM900 and TETRA led to significantly more exposure effects in females. Regardless of gender, none of the observed changes is indicative of a sleep disturbing effect of RF-EMF exposure. Observed effects might be mediated by skin related thermoregulatory mechanisms.",2020,"Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males.","['healthy elderly males and females', '30 elderly healthy male and 30 healthy elderly female volunteers']","['radiofrequency electromagnetic fields', 'radiofrequency electromagnetic fields (RF-EMF', 'RF-EMF exposures (GSM900 and TETRA']","['macrostructure of sleep and arousals', 'number of awakenings', 'self-rated total sleep time', 'peak spatial absorption rate', 'Latency to sleep stage R', 'time awake within the sleep period under TETRA exposure', 'RF-EMF effects']","[{'cui': 'C0686754', 'cui_str': 'Well male elder (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0686755', 'cui_str': 'Well female elder (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1010292', 'cui_str': 'Tetras'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C1010292', 'cui_str': 'Tetras'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",30.0,0.0475033,"Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}]",Environmental research,['10.1016/j.envres.2020.109181']
160,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
161,32306247,Cost-Effectiveness of Insulin Degludec Versus Insulin Glargine U300 in the Netherlands: Evidence From a Randomised Controlled Trial.,"INTRODUCTION


This study aimed to evaluate the short-term cost-effectiveness of insulin degludec 200 units/mL (degludec) versus insulin glargine 300 units/mL (glargine U300) from a Dutch societal perspective.
METHODS


A previously published model estimated costs [2018 euros (EUR)] and effectiveness [quality-adjusted life years (QALYs)] with degludec compared with glargine U300 over a 1-year time horizon. The model captured hypoglycaemia rates and insulin dosing. Clinical outcomes were informed by CONCLUDE (NCT03078478), a head-to-head randomised controlled trial in insulin-experienced patients with type 2 diabetes.
RESULTS


Treatment with degludec was associated with mean annual cost savings (EUR 24.71 per patient) relative to glargine U300, driven by a lower basal insulin dose and lower severe hypoglycaemia rate with degludec compared with glargine U300. Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300. In sensitivity analyses, changes to the vast majority of model parameters did not materially affect model outcomes.
CONCLUSIONS


This short-term analysis, informed by the latest clinical trial evidence, demonstrated that degludec was a cost-effective treatment option relative to glargine U300. As such, our modelling analysis suggests that degludec would represent an efficient use of Dutch public healthcare resources in this patient population.",2020,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,[],"['Insulin Degludec Versus Insulin Glargine', 'insulin degludec 200\xa0units/mL (degludec) versus insulin glargine 300\xa0units/mL (glargine U300']","['severe hypoglycaemia rate', 'effectiveness [quality-adjusted life years (QALYs', 'Lower rates of non-severe nocturnal and severe hypoglycaemia', 'mean annual cost savings']",[],"[{'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.149607,Lower rates of non-severe nocturnal and severe hypoglycaemia resulted in improved effectiveness (+ 0.0045 QALYs) with degludec relative to glargine U300.,"[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'University Hospital Llandough, Penarth, UK. marclyndon1@hotmail.com.'}, {'ForeName': 'Robert G J', 'Initials': 'RGJ', 'LastName': 'Moes', 'Affiliation': 'Novo Nordisk B.V., Alphen aan den Rijn, Netherlands.'}, {'ForeName': 'Katrine S', 'Initials': 'KS', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk Region Europe, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gundgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",Advances in therapy,['10.1007/s12325-020-01332-y']
162,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
163,31767581,Cluster randomised controlled trial to investigate the effectiveness and cost-effectiveness of a Structured Health Intervention For Truckers (the SHIFT study): a study protocol.,"INTRODUCTION


Heavy goods vehicle (HGV) drivers exhibit higher than nationally representative rates of obesity, and obesity-related comorbidities, in comparison to other occupational groups. Their working environments are not conducive to a healthy lifestyle, yet there has been limited attention to health promotion efforts. We have developed a Structured Health Intervention For Truckers (the SHIFT programme), a multicomponent, theory-driven, health-behaviour intervention targeting physical activity, diet and sitting in HGV drivers. This paper describes the protocol of a cluster randomised controlled trial designed to evaluate the effectiveness and cost-effectiveness of the SHIFT programme.
METHODS AND ANALYSIS


HGV drivers will be recruited from a logistics company in the UK. Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers). The 6-month SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a 'cab workout'). Objectively measured total daily physical activity (steps/day) will be the primary outcome. Secondary outcomes include: objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol). Self-report questionnaires will examine fruit and vegetable intake, psychosocial and work outcomes and mental health. Quality of life and resources used (eg, general practitioner visits) will also be assessed. Measures will be collected at baseline, 6 and 12 months and analysed according to a modified intention-to-treat principle. A full process evaluation and cost-effectiveness analysis will be conducted.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Loughborough University Ethics Approvals Sub-Committee (reference: R17-P063). Study findings will be disseminated through publications in research and professional journals, through conference presentations and to relevant regional and national stakeholders via online media and at dissemination events.
TRIAL REGISTRATION NUMBER


ISRCTN10483894.",2019,"Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers).",['HGV drivers will be recruited from a logistics company in the UK'],"['Structured Health Intervention', 'SHIFT intervention or usual-care control', ""SHIFT intervention includes a group-based interactive 6-hour education session, worksite champion support and equipment provision (including a Fitbit and resistance bands/balls to facilitate a 'cab workout"", 'SHIFT programme']","['effectiveness and cost-effectiveness', 'total daily physical activity', ' objectively measured light-intensity physical activity and moderate-to-vigorous physical activity, sitting time, sleep quality, markers of adiposity, blood pressure and capillary blood markers (glycated haemoglobin, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol', 'Quality of life and resources used (eg, general practitioner visits']","[{'cui': 'C0403128', 'cui_str': 'Heavy goods vehicle driver (occupation)'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0185014', 'cui_str': 'Banding'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0034380'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]",,0.187718,"Following baseline measurements, depots (clusters) will be randomised to either the SHIFT intervention or usual-care control arm (12 clusters in each, average cluster size 14 drivers).","[{'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Clemes', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK s.a.clemes@lboro.ac.uk.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Varela Mato', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Fehmidah', 'Initials': 'F', 'LastName': 'Munir', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamer', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Gray', 'Affiliation': 'Department of Health Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Nishal', 'Initials': 'N', 'LastName': 'Bhupendra Jaicim', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Johnson', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030175']
164,32171774,The Impact of Levothyroxine on Cardiac Function in Older Adults With Mild Subclinical Hypothyroidism: A Randomized Clinical Trial.,"BACKGROUND


Subclinical hypothyroidism has been associated with heart failure, but only small trials assessed whether treatment with levothyroxine has an impact on cardiac function.
METHODS


In a randomized, double-blind, placebo-controlled, trial nested within the TRUST trial, Swiss participants ages ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone [TSH] 4.60-19.99 mIU/L; free thyroxine level within reference range) were randomized to levothyroxine (starting dose of 50 µg daily) to achieve TSH normalization or placebo. The primary outcomes were the left ventricular ejection fraction for systolic function and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function. Secondary outcomes included e' lateral/septal, left atrial volume index, and systolic pulmonary artery pressure.
RESULTS


A total of 185 participants (mean age 74.1 years, 47% women) underwent echocardiography at the end of the trial. After a median treatment duration of 18.4 months, the mean TSH decreased from 6.35 mIU/L to 3.55 mIU/L with levothyroxine (n = 96), and it remained elevated at 5.29 mIU/L with placebo (n = 89). The adjusted between-group difference was not significant for the mean left ventricular ejection fraction (62.7% vs 62.5%, difference = 0.4%, 95% confidence interval -1.8% to 2.5%, P = 0.72) and the E/e' ratio (10.6 vs 10.1, difference 0.4, 95% confidence interval -0.7 to 1.4, P = 0.47). No differences were found for the secondary diastolic function parameters or for interaction according to sex, baseline TSH, preexisting heart failure, and treatment duration (P value >0.05).
CONCLUSION


Systolic and diastolic heart function did not differ after treatment with levothyroxine compared with placebo in older adults with mild subclinical hypothyroidism.",2020,"No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05).
","['mean age 74.1 years, 47% women) underwent', '185 participants ', 'Older Adults with Mild Subclinical Hypothyroidism', 'older adults with mild subclinical hypothyroidism', 'Swiss participants aged ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone, TSH, 4.60-19.99 mIU/L; free thyroxine level within reference range']","['TSH normalization, or placebo', 'placebo', 'Levothyroxine', 'echocardiography', 'levothyroxine']","[""e' lateral/septal, left atrial volume index and systolic pulmonary artery pressure"", 'mean TSH', 'mean left ventricular ejection fraction', 'secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration', 'Cardiac Function', ""left ventricular ejection fraction for systolic function, and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function"", 'Systolic and diastolic heart function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439462', 'cui_str': 'milliinternational unit/liter'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0460094', 'cui_str': 'Within reference range (qualifier value)'}]","[{'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}]",185.0,0.763923,"No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05).
","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""Service of Cardiology, University Hospitals of Geneva, University of Geneva, Switzerland; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Department of Health Research & Policy, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Delgiovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Buffle', 'Affiliation': 'Department of Cardiology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Monney', 'Affiliation': 'Service of Cardiology, Department of Heart and Vessels, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gabus', 'Affiliation': 'Service of Cardiology, Department of Heart and Vessels, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Service of Cardiology, University Hospitals of Geneva, University of Geneva, Switzerland.'}, {'ForeName': 'Gerasimos P', 'Initials': 'GP', 'LastName': 'Sykiotis', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kearney', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Center for Healthy Aging, University of Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'University of San Francisco, California, United States.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: nicolas.rodondi@insel.ch.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.01.018']
165,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


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


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


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


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
166,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
167,31718229,Self-administered acupressure for knee osteoarthritis in middle-aged and older adults: a pilot randomized controlled trial.,"OBJECTIVE


To test the acceptability and feasibility of self-administered acupressure as an intervention for knee pain among middle-aged and older adults with knee osteoarthritis (KOA).
METHODS


In this pilot randomized controlled trial, 35 participants with KOA were randomized to receive self-administered acupressure (n = 17, two self-administered acupressure training sessions followed by self-practice for 6 weeks) or knee health education (n = 18, two health education sessions about KOA management followed by self-care for 6 weeks). Current pain intensity (primary outcome) was measured using a Numeric Rating Scale (NRS) at baseline and weeks 1, 2, 4 and 6 (post-intervention). Secondary outcome measures included worst and least pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), range of motion (ROM) of the knee joints and Short-Form Six-Dimension (SF-6D) scores for health-related quality of life.
RESULTS


Participants in both groups attended all training sessions. In the self-administered acupressure group, all subjects mastered the acupressure technique and passed a consistency check. Both groups showed a decreasing trend in current knee pain intensity measured using NRS post-intervention. A medium between-group effect size (0.40) was found, but between-group differences were not statistically significant. The other secondary outcome measures were also comparable between both groups post-intervention (all p > 0.05).
CONCLUSION


A two-session self-administered acupressure training was acceptable to and feasible in participants with KOA. The data generated allowed for calculation of a sample size for a definitive randomized controlled trial (RCT) to confirm whether self-acupressure is effective for pain management in KOA. Furthermore trials with adequate power and longer follow-up periods are warranted.",2020,"The other secondary outcome measures were also comparable between both groups post-intervention (all p > 0.05).
","['middle-aged and older adults', 'knee pain among middle-aged and older adults with knee osteoarthritis (KOA', '35 participants with KOA', 'participants with KOA']","['acupressure training', 'self-administered acupressure', 'acupressure', 'self-administered acupressure (n\u2009=\u200917, two self-administered acupressure training sessions followed by self-practice for 6\u2009weeks) or knee health education (n\u2009=\u200918, two health education sessions about KOA management followed by self-care for 6\u2009weeks', 'Self-administered acupressure']","['current knee pain intensity', 'Numeric Rating Scale (NRS', 'Current pain intensity', 'worst and least pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), range of motion (ROM) of the knee joints and Short-Form Six-Dimension (SF-6D) scores for health-related quality of life']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0018701'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0222045'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",35.0,0.103806,"The other secondary outcome measures were also comparable between both groups post-intervention (all p > 0.05).
","[{'ForeName': 'Denise Shuk Ting', 'Initials': 'DST', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wing-Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Lorna Kwai-Ping', 'Initials': 'LK', 'LastName': 'Suen', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Tsz Chung', 'Initials': 'TC', 'LastName': 'Chong', 'Affiliation': 'TriO Health Sports and Spine Centre Limited, Kowloon, Hong Kong.'}, {'ForeName': 'Yuan-Shan', 'Initials': 'YS', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Branda Yee-Man', 'Initials': 'BY', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Lily Ying-Tung', 'Initials': 'LY', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Hai-Yong', 'Initials': 'HY', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Li-Xing', 'Initials': 'LX', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, Hong Kong.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528419883269']
168,31782309,"Influence of electroacupuncture stimulation on skin temperature, skin blood flow, muscle blood volume and pupil diameter.","OBJECTIVE


To examine the effect of electroacupuncture (EA) stimulation on multiple physiological indices and to evaluate both local and systemic physiological responses induced by the stimulation.
METHODS


15 healthy male college students participated in an experimental crossover study. They received two kinds of interventions: one with EA stimulation and one without EA stimulation on different days. Two disposable acupuncture needles were inserted at two traditional acupuncture points (ST36 and ST38), located along the anterior tibialis muscle. EA stimulation was administered for 10 min. Skin temperature (ST), skin blood flow (SBF) and muscle blood volume (MBV) were recorded near the stimulation sites, while the pupil diameter (PD) was measured before, during and after the interventions.
RESULTS


ST, SBF and MBV increased significantly following EA stimulation. PD of the right and left eyes decreased significantly following EA stimulation. There was a significant difference in ST responses between the groups (P=0.001). For SBF, MBV and PD, no significant differences were demonstrated between the groups.
CONCLUSIONS


Our study showed that 10 min of EA stimulation increased ST, SBF and MBV, and decreased PD, compared to baseline, while no significant change was observed in the control group. This suggests that EA stimulation alters local blood flow and ST, and these responses are likely mediated via segmental spinal reflexes, supraspinal reflexes involving parasympathetic activation, and other mechanisms.",2020,"For SBF, MBV and PD, no significant differences were demonstrated between the groups.
",['15 healthy male college students'],"['EA stimulation and one without EA stimulation', 'electroacupuncture stimulation', 'electroacupuncture (EA) stimulation']","['ST, SBF and MBV, and decreased PD', 'Skin temperature (ST), skin blood flow (SBF) and muscle blood volume (MBV', 'skin temperature, skin blood flow, muscle blood volume and pupil diameter', 'ST, SBF and MBV', 'ST responses', 'pupil diameter (PD']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]",15.0,0.0226322,"For SBF, MBV and PD, no significant differences were demonstrated between the groups.
","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kubota', 'Affiliation': 'Division of Health Sciences, Graduate School of Technology and Science, Tsukuba University of Technology, Tsukuba, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Division of Health Sciences, Graduate School of Technology and Science, Tsukuba University of Technology, Tsukuba, Japan.'}, {'ForeName': 'Tateyuki', 'Initials': 'T', 'LastName': 'Morisawa', 'Affiliation': 'Graduate School of Life and Environmental Sciences, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kazuyo', 'Initials': 'K', 'LastName': 'Hanyu', 'Affiliation': 'Department of Health, Faculty of Health Sciences, Tsukuba University of Technology, Tsukuba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kuge', 'Affiliation': 'Department of Health, Faculty of Health Sciences, Tsukuba University of Technology, Tsukuba, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Health, Faculty of Health Sciences, Tsukuba University of Technology, Tsukuba, Japan.'}, {'ForeName': 'Tim H', 'Initials': 'TH', 'LastName': 'Tanaka', 'Affiliation': 'Department of Health, Faculty of Health Sciences, Tsukuba University of Technology, Tsukuba, Japan.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1136/acupmed-2017-011433']
169,30019950,"Using Electronic Contact to Reduce Homonegative Attitudes, Emotions, and Behavioral Intentions Among Heterosexual Women and Men: A Contemporary Extension of the Contact Hypothesis.","The current study experimentally examined the potential for a contemporary extension of the contact hypothesis, known as electronic contact, or E-contact, to reduce sexual prejudice, intergroup anxiety, and avoidant behavioral intentions among heterosexuals. It also extended the sexual minority contact literature by examining the role of participant and interaction partner sex as a possible boundary condition of this contact-prejudice relationship. To test our hypotheses, 140 heterosexual female and male university students were randomly allocated to interact with a homosexual or heterosexual, female or male E-contact partner, in a collaborative and text-only online interaction before completing the outcome measures. Overall, the results demonstrated that interacting online with a female, as opposed to a male, homosexual E-contact partner reduced heterosexual men's feelings of intergroup anxiety, which in turn was associated with lower sexual prejudice and outgroup avoidance. For heterosexual women, however, E-contact did not influence the outcome variables. In the context of sexual prejudice, these results suggest that E-contact may be particularly useful as a prejudice-reduction strategy among individuals who typically require it most: heterosexual men.",2019,"In the context of sexual prejudice, these results suggest that E-contact may be particularly useful as a prejudice-reduction strategy among individuals who typically require it most: heterosexual men.","['individuals who typically require it most: heterosexual men', '140 heterosexual female and male university students', 'Heterosexual Women and Men']","['homosexual or heterosexual, female or male E-contact partner, in a collaborative and text-only online interaction']","['Homonegative Attitudes, Emotions, and Behavioral Intentions']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0204308,"In the context of sexual prejudice, these results suggest that E-contact may be particularly useful as a prejudice-reduction strategy among individuals who typically require it most: heterosexual men.","[{'ForeName': 'Fiona A', 'Initials': 'FA', 'LastName': 'White', 'Affiliation': 'School of Psychology, The University of Sydney , Sydney , Australia.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Verrelli', 'Affiliation': 'School of Psychology, The University of Sydney , Sydney , Australia.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Maunder', 'Affiliation': 'School of Psychology, The University of Sydney , Sydney , Australia.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Kervinen', 'Affiliation': 'School of Psychology, The University of Sydney , Sydney , Australia.'}]",Journal of sex research,['10.1080/00224499.2018.1491943']
170,32216084,Population and Noncompartmental Pharmacokinetics of Sodium Oxybate Support Weight-Based Dosing in Children and Adolescents With Narcolepsy With Cataplexy.,"The pharmacokinetics (PKs) of sodium oxybate (SXB) was evaluated in a subset of participants from a study of SXB treatment in children (aged 7-11 years; n = 11) and adolescents (aged 12-17 years; n = 18) with narcolepsy with cataplexy. PK evaluation was conducted over 2 nights during the period when participants received a stable nightly SXB dose. The SXB dose on night 1 was half of night 2 and was administered in two equally divided doses: dose 1 was administered > 2 hours after the evening meal, and dose 2 was administered ≥ 4 hours after dose 1. Noncompartmental PK analysis demonstrated higher plasma concentrations post-dose 2 vs. post-dose 1, higher than dose-proportional increases in area under the concentration-time curve from 0 to 4 hours (AUC 0-4h  ) after dose 1, indicating nonlinear clearance, and better correlation between exposure and mg/kg than exposure and gram dose. To confirm the noncompartmental findings, identify factors affecting SXB PK, and compare with prior results in adults, a population PK (PopPK) model was established combining PK data from the current study with prior data from adults (132 healthy volunteers and 13 with narcolepsy). A two-compartment PopPK model with first-order absorption and nonlinear clearance from the central compartment described the data well. PopPK identified weight as the main intrinsic factor and food as the main extrinsic factor affecting SXB PK, and predicts similar PK profiles on a mg/kg basis across ages. These results, along with previously reported efficacy and safety outcomes, support weight-based SXB dose initiation in pediatric patients.",2020,"Noncompartmental PK analysis demonstrated higher plasma concentrations post-dose 2 versus post-dose 1, higher than dose-proportional increases in area under the concentration-time curve from 0 to 4 hours (AUC 0-4h  ) after dose 1, indicating nonlinear clearance, and better correlation between exposure and mg/kg than exposure and gram dose.","['subset of participants from a study of SXB treatment in children (aged 7-11 years; n=11) and adolescents (aged 12-17 years; n=18) with narcolepsy with cataplexy', '132 healthy volunteers, 13 with narcolepsy', 'Children and Adolescents With Narcolepsy With Cataplexy']","['Sodium Oxybate Support Weight-Based Dosing', 'sodium oxybate (SXB']","['efficacy and safety outcomes, support weight-based SXB dose initiation', 'plasma concentrations']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0007384', 'cui_str': 'Henneberg Syndrome'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037537', 'cui_str': 'Sodium Oxybate'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",132.0,0.0224674,"Noncompartmental PK analysis demonstrated higher plasma concentrations post-dose 2 versus post-dose 1, higher than dose-proportional increases in area under the concentration-time curve from 0 to 4 hours (AUC 0-4h  ) after dose 1, indicating nonlinear clearance, and better correlation between exposure and mg/kg than exposure and gram dose.","[{'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Rosen', 'Affiliation': ""Division of Pediatric Pulmonology and Sleep Medicine, Rainbow Babies & Children's Hospital, Cleveland, Ohio, USA.""}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Ruoff', 'Affiliation': 'Stanford University Sleep Medicine Center, Redwood City, California, USA.'}, {'ForeName': 'Leslie H', 'Initials': 'LH', 'LastName': 'Boyce', 'Affiliation': 'Raleigh Neurology Associates, Raleigh, North Carolina, USA.'}, {'ForeName': 'Rupa', 'Initials': 'R', 'LastName': 'Parvataneni', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zomorodi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, California, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Brantley', 'Affiliation': 'Nuventra Pharma Sciences, Durham, North Carolina, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sale', 'Affiliation': 'Nuventra Pharma Sciences, Durham, North Carolina, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}]",Clinical and translational science,['10.1111/cts.12780']
171,32307124,"Changes in Firearm and Medication Storage Practices in Homes of Youths at Risk for Suicide: Results of the SAFETY Study, a Clustered, Emergency Department-Based, Multisite, Stepped-Wedge Trial.","STUDY OBJECTIVE


We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
METHODS


We used a stepped-wedge clustered design rolled out at 4 hospital sites to assess primary preregistered outcomes (self-reported storage changes caregivers made to household firearms and medications), assessed by survey 2 weeks after the ED visit. Three logistic models provided estimates of the intervention effect: an unadjusted model, a model with hospital-level fixed effects, and a model that further adjusts for time.
RESULTS


Of the 575 caregiver participants, 208 were firearm owners (123 in usual care, 85 in the intervention). Baseline (pre-ED visit) characteristics did not differ between usual care and intervention phases. During the 2-year study period, twice as many caregivers whose child visited the ED after (compared with before) a hospital adopted the intervention improved firearm storage and 3 times as many improved medication storage (odds ratio [OR]=2.1 [95% confidence interval {CI} 1.0 to ∞] and OR=3.0 [95% CI 2.2 to ∞], respectively). After adjusting for time, the intervention effect for medications persisted (OR=2.0 [95% CI 1.0 to ∞]); the effect on firearms did not (OR=0.7 [95% CI 0.1 to ∞]).
CONCLUSION


To our knowledge, this study is the first controlled trial to estimate the effectiveness of an intervention on firearm and medication storage in homes of youths at elevated risk of suicide. We found evidence that caregivers' medication storage improved after their child's ED visit, with evidence suggestive of improvement for firearm storage.",2020,"We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
","[""caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern"", 'Homes of Youths at Risk for Suicide', 'homes of youths at elevated risk of suicide', 'Of the 575 caregiver participants, 208 were firearm owners (123 in usual care, 85 in the intervention']",['counseling intervention'],['firearm storage and 3 times as many improved medication storage'],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0016139', 'cui_str': 'Firearm'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",575.0,0.122917,"We evaluate whether a counseling intervention implemented at the hospital level resulted in safer firearm and medication storage by caregivers of youths aged 10 to 17 years after their child's evaluation in the emergency department (ED) for a behavioral health concern.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Northeastern University, Boston, MA; Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA. Electronic address: ma.miller@northeastern.edu.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Salhi', 'Affiliation': 'Northeastern University, Boston, MA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Barber', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Azrael', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beatriz', 'Affiliation': 'Northeastern University, Boston, MA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Berrigan', 'Affiliation': 'Harvard Injury Control Research Center, Harvard Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Brandspigel', 'Affiliation': 'Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Betz', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Runyan', 'Affiliation': 'Colorado School of Public Health, Aurora, CO.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.02.007']
172,32301258,Intravenous immunoglobulin significantly reduces exposure of concomitantly administered anti-C5 monoclonal antibody tesidolumab.,"Awareness of drug-drug interactions is critical in organ transplant recipient management. However, biologic agents interfering with monoclonal antibodies is not widely considered. We report the effect of high-dose intravenous immunoglobulin (IVIg) on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the human anti-C5 monoclonal antibody tesidolumab (LFG316) in end-stage renal disease patients awaiting kidney transplant. In this single-center, phase 1, open-label, parallel-group study, 8 patients were assigned to receive either single-dose tesidolumab + IVIg or tesidolumab alone, with 56-day follow-up. Within-group PK parameters were consistent. Mean tesidolumab exposure decreased 34%, clearance increased 63%, and half-life decreased 41% comparing tesidolumab + IVIg to tesidolumab alone. IVIg influence on tesidolumab elimination was most evident in the first 3 weeks. Complete suppression of both total and alternative complement activities was maintained for 4 weeks in the tesidolumab alone group and for 2 weeks in the tesidolumab + IVIg group. Tesidolumab was well tolerated. IVIg infused before tesidolumab affected tesidolumab PK and PD, resulting in a shortened period of full complement activity inhibition. These findings suggest a clinically relevant impact of IVIg on monoclonal antibody clearance and indirectly hint at an IVIg mechanism of action in treating autoimmune diseases and allosensitization by accelerating pathogenic IgG antibody degradation. Trial registration number: NCT02878616.",2020,Complete suppression of both total and alternative complement activities was maintained for 4 weeks in the tesidolumab alone group and for 2 weeks in the tesidolumab+IVIg group.,['end-stage renal disease patients awaiting kidney transplant'],"['Intravenous Immunoglobulin', 'tesidolumab+IVIg', 'high-dose intravenous immunoglobulin (IVIg', 'tesidolumab+IVIg or tesidolumab alone, with 56-day follow-up', 'Tesidolumab', 'human anti-C5 monoclonal antibody tesidolumab (LFG316']","['Complete suppression of both total and alternative complement activities', 'tolerated', 'safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD', 'Mean tesidolumab exposure', 'tesidolumab elimination']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",8.0,0.0177664,Complete suppression of both total and alternative complement activities was maintained for 4 weeks in the tesidolumab alone group and for 2 weeks in the tesidolumab+IVIg group.,"[{'ForeName': 'Stanley C', 'Initials': 'SC', 'LastName': 'Jordan', 'Affiliation': 'Comprehensive Transplant Center, Transplant Immunotherapy Program Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kucher', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Bagger', 'Affiliation': 'Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Hockey', 'Affiliation': 'Biometrics Matters Ltd., Hamilton, New Zealand.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Ammerman', 'Affiliation': 'Comprehensive Transplant Center, Transplant Immunotherapy Program Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vo', 'Affiliation': 'Comprehensive Transplant Center, Transplant Immunotherapy Program Cedars-Sinai Medical Center, Los Angeles, California, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15922']
173,30770519,"Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial.","OBJECTIVE


Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA).
METHODS


This phase III, randomized, double-blind, placebo-controlled trial (GO-VIBRANT) randomized patients with active PsA to receive IV placebo (n = 239) or IV GOL 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Radiographic progression (controlled secondary endpoint) was evaluated as change from baseline at Week 24 in PsA-modified total Sharp/van der Heijde scores (SvdH). The proportions of patients with a change from baseline at Week 24 in the total PsA-modified SvdH exceeding the smallest detectable change (SDC) or > 0 or 0.5 also were determined.
RESULTS


Overall, 474 patients (237/arm) contributed radiographic data. Results obtained from the 2 blinded, independent radiographic readers demonstrated good agreement (total score intraclass correlation coefficients: baseline = 0.93, Week 24 = 0.92, Week 24 change score = 0.73). GOL demonstrated significant inhibition of radiographic progression relative to placebo from baseline to Week 24 (mean changes in PsA-modified total SvdH: -0.36 vs 1.95; treatment difference: -2.32; p < 0.001). At Week 24, smaller proportions of GOL- versus placebo-treated patients demonstrated an increase in the total PsA-modified SvdH score exceeding the SDC (8.0% vs 27.0%, respectively; difference: -19.0%; p < 0.001), > 0 (28.3% vs 57.0%, respectively; difference: -28.7%; p < 0.001), or > 0.5 (18.6% vs 41.8%, respectively; difference: -23.2%; p < 0.001). Results were consistent for erosion and joint space narrowing scores, in hands and feet, and in patients with/without baseline concomitant methotrexate use. Prevention of radiographic progression by GOL was independent of clinical response.
CONCLUSION


IV GOL is significantly better than placebo in inhibiting radiographic progression of structural damage in active PsA. [Clinical trial registration number (www.ClinicalTrials.gov): NCT02181673].",2019,GOL demonstrated significant inhibition of radiographic progression relative to placebo from baseline to Week 24 (mean changes in PsA-modified total SvdH: -0.36 vs 1.95; treatment difference: -2.32; p < 0.001).,"['psoriatic arthritis (PsA', 'patients with active PsA to receive', 'n = 239) or', 'Psoriatic Arthritis', '474 patients (237/arm) contributed radiographic data']","['IV placebo', 'Intravenous Golimumab', 'placebo', 'IV GOL', 'Placebo', 'intravenous (IV) golimumab (GOL']","['Radiographic Progression Inhibition', 'radiographic progression', 'erosion and joint space narrowing scores', 'total PsA-modified SvdH score', 'Radiographic progression']","[{'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C1859695'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",474.0,0.671233,GOL demonstrated significant inhibition of radiographic progression relative to placebo from baseline to Week 24 (mean changes in PsA-modified total SvdH: -0.36 vs 1.95; treatment difference: -2.32; p < 0.001).,"[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Noonan', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'From Internal Medicine - Rheumatology, University of California at San Diego, La Jolla, California; Department of Internal Medicine - Rheumatology, Cleveland Clinic, Cleveland, Ohio; Immunology, Janssen Research & Development LLC, Spring House, Pennsylvania; Rheumatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA. ehsia@its.jnj.com.'}]",The Journal of rheumatology,['10.3899/jrheum.180681']
174,30709557,Effectiveness and safety of combined neurokinin-1 antagonist aprepitant treatment for multiple-day anthracycline-induced nausea and vomiting.,"OBJECTIVE


To assess the safety and efficacy of combined neurokinin-1 antagonist aprepitant treatment for multiple-day anthracycline chemotherapy-induced nausea and vomiting.
METHODS


One hundred patients with breast cancer from department of Medical Oncology of Ordos Central Hospital from June 2015 to February 2018 were selected and randomize subdivided into 2 groups. All cases received anthracycline (30 mg/m 2 /d for pirarubicin or 45 mg/m 2 /d for epirubicin) and cyclophosphamide adjuvant chemotherapy, along with either the standard therapy (dexamethasone and tropisetron) or the combined aprepitant therapy (aprepitant plus dexamethasone and tropisetron). The results of the observation between groups were presented by complete response in the overall phase (OP, 0-120 hours), acute phase (AP, 0-24 hours) and delay phase (DP, 25-120 hours). The Kaplan-Meier curves were plotted to exhibit the first time of vomiting, Functional Living Index-Emesis of patients' quality of life, and therapy-related adverse effects (AEs).
RESULTS


The complete response of OP, AP, and DP were statistically different between aprepitant group and standard group (80.0% vs 48%, P = 0.001; 92.0% vs 74%, P = 0.017; 80.0% vs 48%, P = 0.001). The aprepitant group held a longer time reaching the first emesis after the relevant treatment than the standard group. The Functional Living Index-Emesis increased significantly in the aprepitant group compared with the standard group (24% vs 8.3%, P = 0.029). Fatigue and constipation were the only AEs of aprepitant, since no significant differences were observed in fatigue between the 2 groups (72% vs 70%, P = 0.826), while the incidence of constipation of aprepitant group was higher than the standard group (48% vs 28%, P = 0.039).
CONCLUSION


Combined aprepitant therapy is efficient and safe in the multiple-day anthracycline chemotherapy-induced nausea and vomiting control and is recommended for the clinical use.",2019,"The Functional Living Index-Emesis increased significantly in the aprepitant group compared with the standard group (24% vs 8.3%, P = 0.029).",['One hundred patients with breast cancer from department of Medical Oncology of Ordos Central Hospital from June 2015 to February 2018'],"['cyclophosphamide adjuvant chemotherapy', 'combined neurokinin-1 antagonist aprepitant', 'standard therapy (dexamethasone and tropisetron', 'combined aprepitant therapy (aprepitant plus dexamethasone and tropisetron', 'epirubicin', 'pirarubicin', 'anthracycline']","['incidence of constipation', 'nausea and vomiting', 'safety and efficacy', 'fatigue', 'Functional Living Index-Emesis', ""vomiting, Functional Living Index-Emesis of patients' quality of life, and therapy-related adverse effects (AEs"", 'complete response of OP, AP, and DP', 'longer time reaching the first emesis', 'Fatigue and constipation', 'Effectiveness and safety']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0071126', 'cui_str': 'Pirarubicin'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",100.0,0.0325489,"The Functional Living Index-Emesis increased significantly in the aprepitant group compared with the standard group (24% vs 8.3%, P = 0.029).","[{'ForeName': 'Quanfu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Yungaowa', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Wenjuan', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Jixiang', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Lenggaowa', 'Initials': 'L', 'LastName': 'Da', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Lanzhen', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia.'}, {'ForeName': 'Gaowa', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Oncology, Ordos Central Hospital, Ordos, Mongolia. Electronic address: jingaowank@163.com.'}]",Current problems in cancer,['10.1016/j.currproblcancer.2019.01.003']
175,32300897,"Therapeutic effects of proprioceptive exercise on functional capacity, anxiety, and depression in patients with diabetic neuropathy: a 2-month prospective study.","BACKGROUND


Diabetic neuropathy (DN) is a common and serious complication of diabetes. DN patients are suffering from anxiety, depression, and impairment of functional capacity. Rare studies have assessed the effect of proprioceptive exercise training on anxiety, depression, and functional capacity in DN patients.
AIMS


This 2-month prospective study aims to investigate the effect of proprioceptive exercise training on anxiety, depression, and functional capacity in DN patients.
METHODS


Twenty-eight DN patients with a mean age of 53.2 ± 5.5 years were included in this prospective study between September and December 2019. They were randomly assigned into two groups, 14 in each group using a random number generator. The proprioceptive exercise group (PEG) received a program of proprioceptive exercise, while the control group (CG) received a conventional treatment without exercise intervention. Berg Balance Scale (BBS), Six-Minute Walk Test (6MWT), Beck Anxiety Inventory (BAI), and Hamilton Depression Rating Scale (HDRS) were investigated before and after 2 months of the study period.
RESULTS


The findings showed a significant improvement of the BBS, 6MWT, BAI, and HDRS in the PEG (p = 0.003, p < 0.001, p = 0.001, and p = 0.001, respectively) while non-significant changes in the CG (p > 0.05). Comparison between the two groups showed significant differences between the two groups in the all outcome measures in favor of the PEG at the end of the 2 months (BBS, p = 0.032; 6MWT, p = 0.001; BAI, p = 0.031; and HDRS, p = 0.013).
CONCLUSIONS


Two months of proprioceptive exercise may improve functional capacity, anxiety, and depression in DN patients. Serious recommendations should be devoted to encouraging the proprioceptive exercise training among different population, especially DN patients. Key Points • Proprioceptive exercise may improve postural stability in patients with diabetic neuropathy. • Proprioceptive exercise may improve psychological status and functional capacity in patients with diabetic neuropathy. • Serious recommendations should be devoted to encouraging the proprioceptive exercise training among diabetic patients.",2020,"Comparison between the two groups showed significant differences between the two groups in the all outcome measures in favor of the PEG at the end of the 2 months (BBS, p = 0.032; 6MWT, p = 0.001; BAI, p = 0.031; and HDRS, p = 0.013).
","['patients with diabetic neuropathy', 'patients with diabetic neuropathy.•', 'DN patients', 'Twenty-eight DN patients with a mean age of 53.2\u2009±\u20095.5\xa0years were included in this prospective study between September and December 2019', 'diabetic patients', 'patients with diabetic neuropathy.• Serious recommendations']","['proprioceptive exercise', 'Key Points• Proprioceptive exercise', 'proprioceptive exercise training', 'Proprioceptive exercise', 'proprioceptive exercise group (PEG) received a program of proprioceptive exercise, while the control group (CG) received a conventional treatment without exercise intervention']","['BBS, 6MWT, BAI, and HDRS in the PEG', 'functional capacity, anxiety, and depression', 'anxiety, depression, and functional capacity', 'Berg Balance Scale (BBS), Six-Minute Walk Test (6MWT), Beck Anxiety Inventory (BAI), and Hamilton Depression Rating Scale (HDRS', 'postural stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0160637,"Comparison between the two groups showed significant differences between the two groups in the all outcome measures in favor of the PEG at the end of the 2 months (BBS, p = 0.032; 6MWT, p = 0.001; BAI, p = 0.031; and HDRS, p = 0.013).
","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia. walidkamal.wr@gmail.com.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Yassen', 'Affiliation': 'Department of Physical Therapy, Kasr Al-Aini Hospital, Cairo University, Giza, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Ahmed', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Clinical rheumatology,['10.1007/s10067-020-05086-4']
176,32298853,Treatment Benefit with Omalizumab in Children by Indicators of Asthma Severity.,"BACKGROUND


Greater severity in childhood asthma negatively impacts functioning and quality of life. Omalizumab is effective in children aged 6 years or older with moderate to severe persistent asthma, but predicting responsiveness in severe disease requires further study.
OBJECTIVE


To assess response to omalizumab treatment among children using indicators of asthma severity.
METHODS


Post hoc analyses of randomized placebo-controlled studies of omalizumab (Inner-City Anti-IgE Therapy for Asthma [ICATA], IA05, and Preventative Omalizumab or Step-up Therapy for Fall Exacerbations [PROSE]) stratified by body mass index, eosinophil count, fractional exhaled nitric oxide levels, and baseline severity indicators (baseline percent predicted FEV 1 , previous hospitalizations, asthma exacerbations). Poisson regression analysis examined exacerbation rate reductions for body mass index, biomarkers, and severity indicators.
RESULTS


Children aged 6 to 11 years in IA05 (N = 576; 56% white, 17% black, 26% other/missing), ICATA (N = 237; 55% black, 43% Hispanic), and PROSE (N = 342; 59% black, 35% Hispanic) were included. Trends indicative of greater exacerbation rate change ([omalizumab - placebo]/placebo) were observed for low baseline lung function (IA05 percent predicted FEV 1 : <90%, 36% reduction, 95% CI, -53.3 to -13.5; ≥90%, 22% reduction, 95% CI, -52.1 to 27.5), previous hospitalizations (ICATA: 46% reduction with, 95% CI, -69.7 to -3.9; 24% reduction without, 95% CI, -48.1 to 10.3), frequent baseline exacerbations (IA05: ≥3, 42% reduction, 95% CI, -60.4 to -14.1; <3, 20% reduction, 95% CI, -45.2 to -15.9), and high baseline eosinophil count (IA05: ≥300 cells/μL, 39% reduction, 95% CI, -56.4 to -14.7; <300 cells/μL, 5% reduction, 95% CI, -40.6 to 52.1).
CONCLUSIONS


Omalizumab reduces exacerbations in children with moderate to severe persistent allergic asthma, and may provide greater benefit in children with more severe asthma subtypes.",2020,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","['Children aged 6-11 years in IA05 (N=576', 'IA05: ≥300 cells/μL, 39% reduction, 95%CI: -56.4, -14.7; <300 cells/μL, 5% reduction, 95%CI: -40.6, 52.1', 'children using indicators of asthma severity', 'children with moderate-to-severe persistent allergic asthma', ' 56% White, 17% Black, 26% Other/Missing), ICATA (N=237; 55% Black, 43% Hispanic), and PROSE (N=342; 59% Black, 35% Hispanic', 'children aged ≥6 years with moderate-to-severe persistent asthma']","['Omalizumab', 'placebo', 'omalizumab']","['forced expiratory volume in 1 second [ppFEV 1 ], prior hospitalizations, asthma exacerbations', 'high baseline eosinophil count', 'body mass index (BMI), eosinophil count, fractional exhaled nitric oxide (FeNO) levels, and baseline severity indicators']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0581122', 'cui_str': 'Asthma severity'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",,0.524462,"Trends indicative of greater exacerbation rate change ([omalizumab-placebo]/placebo) were observed for low baseline lung function (IA05 ppFEV 1 : <90%, 36% reduction, 95%CI: -53.3,","[{'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Pediatric Asthma Research Program, Breathing Institute, Children's Hospital Colorado, and University of Colorado School of Medicine, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org.""}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tmirah', 'Initials': 'T', 'LastName': 'Haselkorn', 'Affiliation': 'EpiMetrix, Inc, Los Altos, Calif.'}, {'ForeName': 'Bongin', 'Initials': 'B', 'LastName': 'Yoo', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ortiz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Kattan', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.033']
177,32304710,Presoaking of Semitendinosus Graft With Vancomycin Does Not Alter Its Biomechanical Properties: A Biomechanical In Vitro-Controlled Study Using Graft From Living Donors.,"PURPOSE


To compare the biomechanical properties of human semitendinosus graft presoaked with or without vancomycin under a load to failure tensile test.
METHODS


Thirty semitendinosus grafts harvested during anterior cruciate ligament reconstruction were included. These were dissected equally into 2 halves and subsequently randomly allocated to a vancomycin group and to a control group. A digital caliper was used to precisely measure each samples thickness, length, and width. For the vancomycin group, samples were presoaked in a solution of 5 mg/mL vancomycin for a duration of 10 minutes and the control group samples were presoaked in a physiological serum equally for 10 minutes. Mechanical testing was performed on a universal testing machine (Instron 5566-A) after a preconditioning of 10 cycles of 1 mm extension and a progression of 10 mm/min to failure for each sample. The stress-strain curve was obtained to determine the elastic modulus (Young's modulus), the ultimate tensile stress, the ultimate tensile elongation (UTE) before failure and the elasticity limit.
RESULTS


For the control group, the average Young's modulus value was 4.8 ± 0.8, the average UTS was 25.2 ± 5.2 MPa, the average percentage of UTE was 78 ± 17%, and the average elasticity limit value was 17.3 ± 5.3 MPa. For the vancomycin group, the average Young's modulus value was 4.7 ± 0.9, the average ultimate tensile stress was 24.1 ± 6.1 MPa, the average percentage of UTE was 82 ± 14%, and the average elasticity limit value was 18.5 ± 5.9 MPa. No significant difference was observed between the 2 groups for all investigated parameters.
CONCLUSIONS


Presoaking of human semitendinosus graft with vancomycin does not alter its biomechanical properties.
CLINICAL RELEVANCE


This study demonstrates that vancomycin presoaking used to prevent post-anterior cruciate ligament reconstruction septic arthritis does not affect immediate biomechanical properties of semitendinosus tendons.",2020,"The stress-strain curve was obtained to determine the elastic modulus (Young's modulus), the Ultimate Tensile Stress (UTS), the Ultimate Tensile Elongation (UTE) before failure and the elasticity limit.
","['graft from living donors', 'Thirty semitendinosus grafts harvested during ACL reconstruction were included']","['vancomycin', 'human semitendinosus graft pre-soaked with or without vancomycin']","['stress-strain curve', 'Ultimate Tensile Stress (UTS), the Ultimate Tensile Elongation (UTE) before failure and the elasticity limit']","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0204774', 'cui_str': 'Soak'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",,0.0163028,"The stress-strain curve was obtained to determine the elastic modulus (Young's modulus), the Ultimate Tensile Stress (UTS), the Ultimate Tensile Elongation (UTE) before failure and the elasticity limit.
","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Jacquet', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Jaubert', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pioger', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Abderahmane', 'Initials': 'A', 'LastName': 'Sbihi', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Pithioux', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Le Baron', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France; Institut de Chirurgie Orthopédique et Sportive, Marseille, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Ollivier', 'Affiliation': 'Institute of Movement and Locomotion, Department of Orthopedics and Traumatology, St. Marguerite Hospital, Marseille, France. Electronic address: matthieu.ollivier@ap-hm.fr.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.03.037']
178,32304731,Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity.,"Food insecurity, the inability to acquire adequate food due to insufficient resources for food, is associated with an increased risk for obesity and associated health problems. This study assessed the feasibility and initial efficacy of a prefilled online grocery shopping cart (i.e., default option) in promoting healthier grocery purchases in individuals with food insecurity. Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits. Compared to nutrition education, the default shopping cart resulted in the purchase of significantly more ounces of whole grains (Mean Difference [M diff ] = -4.05; 95% Confidence Interval [CI] = -6.14, -1.96; p < .001), cups of fruits (M diff  = -1.51; 95% CI = -2.51, -0.59; p = .002) and vegetables (M diff  = -2.21; 95% CI = -4.01, -0.41; p = .02), foods higher in fiber (mg; M diff  = -15.65; 95% CI = -27.43, -3.87; p = .01), and lower in sodium (mg; M diff  = 1642.66; 95% CI = 660.85, 2624.48; p = .002), cholesterol (mg; M diff  = 463.86; 95% CI = 198.76, 728.96; p = .001), and grams of fat (M diff  = 75.42; 95% CI = 42.81, 108.03; p < .001) and saturated fat (M diff  = 26.20; 95% CI = 14.07, 38.34; p < .001). The use of a default online shopping cart appears to improve nutritional quality of food purchases in individuals facing financial constraints.",2020,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","['individuals with food insecurity', 'Fifty participants recruited from food pantries in New York in 2018 were randomized to', 'individuals facing financial constraints']","['review nutrition information before purchasing groceries online (n\u202f=\u202f23) or modify a prefilled, nutritionally balanced online shopping cart (n\u202f=\u202f27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits', 'prefilled online grocery shopping cart (i.e., default option']","['grams of fat (M diff', 'nutritional quality of food purchases', 'saturated fat', 'feasibility and initial efficacy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0441061', 'cui_str': 'Shopping cart'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}]","[{'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3489446', 'cui_str': 'Nutritive Quality'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.161297,"Fifty participants recruited from food pantries in New York in 2018 were randomized to review nutrition information before purchasing groceries online (n = 23) or modify a prefilled, nutritionally balanced online shopping cart (n = 27) based on a budget corresponding to Supplemental Nutrition Assistance Program benefits.","[{'ForeName': 'Jaime A', 'Initials': 'JA', 'LastName': 'Coffino', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA. Electronic address: jcoffino@albany.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Udo', 'Affiliation': 'Department of Health Policy, Management, and Behavior, University at Albany, State University of New York, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, USA.'}]",Appetite,['10.1016/j.appet.2020.104714']
179,31821014,"Predictors of Pain, Function, and Change in Patellofemoral Pain.","BACKGROUND


Identification of factors predictive of outcome and change is important to improve treatment for patellofemoral pain (PFP). Few studies have examined the predictive value of psychological factors in PFP, although they have been reported to be important predictors in other musculoskeletal pain conditions.
PURPOSE


To evaluate predictors of pain, function, and change 1 year after an exercise-based intervention in PFP.
STUDY DESIGN


Cohort study; Level of evidence, 3.
METHODS


In sum, 112 patients were recruited to a randomized controlled trial; 98 attended 1-year follow-up. There were no between-group differences in the trial; thus, the material was analyzed as 1 cohort. Nine baseline factors-sex, bilateral pain, worst pain, pain duration, Anterior Knee Pain Scale (AKPS), kinesiophobia, anxiety and depression, self-efficacy, and number of pain sites throughout the body-were investigated for their predictive ability on outcome at 1 year (AKPS, worst pain) and for change at 1 year (global change score, change in AKPS, and change in worst pain). Multivariable linear regression models with stepwise backward removal method were used to find predictors of poor outcome.
RESULTS


Number of pain sites at baseline was a significant predictor of worse outcome for AKPS ( B  = -2.7; 95% CI, -4.0 to -1.3;  P  < .01), worst pain ( B  = 0.5; 95% CI, 0.2-0.8;  P  < .01), global change ( B  = -0.8; 95% CI, -1.2 to -0.5;  P  < .01), change in AKPS ( B  = -2.7; 95% CI, -4.0 to -1.3;  P  < .01), and change in worst pain ( B  = 0.5, 95% CI, 0.2-0.8;  P  < .01) at 1 year. Baseline scores for AKPS and worst pain predicted respective 1-year levels and change scores ( P  < .01). Lower self-efficacy and male sex predicted less global change ( P  < .01). Longer pain duration predicted final score and change score for worst pain ( P  < .01). The predictive models had reasonable fit with adjusted  R 2  from 0.22 to 0.35.
CONCLUSION


Higher number of pain sites throughout the body was a consistent predictor of poor outcome and less change at 1 year. Baseline levels for AKPS and worst pain predicted respective final scores and change scores.
REGISTRATION


NCT02114294 ( ClinicalTrials.gov identifier).",2020,Baseline scores for AKPS and worst pain predicted respective 1-year levels and change scores ( P  < .01).,"['patellofemoral pain (PFP', '112 patients were recruited to a randomized controlled trial; 98 attended 1-year follow-up']",[],"['worst pain', 'Nine baseline factors-sex, bilateral pain, worst pain, pain duration, Anterior Knee Pain Scale (AKPS), kinesiophobia, anxiety and depression, self-efficacy, and number of pain sites', 'global change', 'Lower self-efficacy', 'Longer pain duration predicted final score and change score for worst pain', 'predictive ability on outcome at 1 year (AKPS, worst pain) and for change at 1 year (global change score, change in AKPS, and change in worst pain', 'Pain, Function, and Change in Patellofemoral Pain', 'change in worst pain', 'change in AKPS ( B', 'Higher number of pain sites']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",112.0,0.13014,Baseline scores for AKPS and worst pain predicted respective 1-year levels and change scores ( P  < .01).,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hott', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Sørlandet Hospital Kristiansand, Kristiansand, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Are Hugo', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Niels Gunnar', 'Initials': 'NG', 'LastName': 'Juel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Liavaag', 'Affiliation': 'Department of Orthopedic Surgery, Sørlandet Hospital Kristiansand, Kristiansand, Norway.'}]",The American journal of sports medicine,['10.1177/0363546519889623']
180,31987653,Neurodevelopmental Outcomes of Neonates Randomized to Morphine or Methadone for Treatment of Neonatal Abstinence Syndrome.,"OBJECTIVE


To evaluate the effects of pharmacologic treatment of neonatal abstinence syndrome on neurodevelopmental outcome from a randomized, controlled trial.
STUDY DESIGN


Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on methadone or buprenorphine into a randomized trial of morphine vs methadone. Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale. At 18 months, 83 of 99 infants (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development-Third Edition and 77 of 99 (77.7%) with the Child Behavior Checklist (CBCL).
RESULTS


Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL. However in post hoc analyses, we found differences by atypical NICU Network Neurobehavioral Scale profile on the CBCL. Infants receiving adjunctive phenobarbital had lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems on the CBCL. In adjusted analyses, internalizing and total behavior problems were associated with use of phenobarbital (P = .03; P = .04), maternal psychological distress (measured by the Brief Symptom Inventory) (both P < .01), and infant medical problems (both P = .02). Externalizing problems were associated with maternal psychological distress (P < .01) and continued maternal substance use (P < .01).
CONCLUSIONS


Infants treated with either morphine or methadone had similar short-term and longer term neurobehavioral outcomes. Neurodevelopmental outcome may be related to the need for phenobarbital, overall health of the infant, and postnatal caregiving environment.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01958476.",2020,"RESULTS


Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL.","['Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on', 'Neonatal Abstinence Syndrome', 'Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale', 'neonatal abstinence syndrome']","['morphine vs methadone', 'morphine or methadone', 'methadone or buprenorphine', 'Morphine or Methadone', 'pharmacologic treatment', 'adjunctive phenobarbital']","['lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems', 'infant medical problems', 'Externalizing problems', 'NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL', 'need for phenobarbital, overall health of the infant, and postnatal caregiving environment', 'Child Behavior Checklist (CBCL', 'continued maternal substance use', 'atypical NICU Network Neurobehavioral Scale profile', 'similar short-term and longer term neurobehavioral outcomes', 'maternal psychological distress', 'internalizing and total behavior problems']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0222045'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0441796', 'cui_str': 'Third edition (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",116.0,0.114946,"RESULTS


Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL.","[{'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Czynski', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI. Electronic address: ACzynski@wihri.org.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Boston, MA; The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Dansereau', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Engelhardt', 'Affiliation': ""Department of Pediatrics, Monroe Carell Jr Children's Hospital at Vanderbilt, Nashville, TN.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marro', 'Affiliation': 'Department of Pediatrics, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Bogen', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'Department of Pediatrics, Jacksonville-University of Florida Health, Jacksonville, FL.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Shenberger', 'Affiliation': 'Department of Pediatrics, Baystate Medical Center, Springfield, MA.'}, {'ForeName': 'Elisha M', 'Initials': 'EM', 'LastName': 'Wachman', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, MA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Oliveira', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Lester', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI; Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.018']
181,31940222,Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.,"BACKGROUND


Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure.
HYPOTHESIS


We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively.
RESULTS


A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52;  P  < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83;  P  < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( P  = .003) and KOOS ( P  = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( P  = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P  = .11).
CONCLUSION


The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery.
REGISTRATION


NCT02018354 ( ClinicalTrials.gov identifier).",2020,"The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P  = .11).
","['618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years', 'Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction', 'A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL', 'Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL']","['hamstring ACLR in combination with a lateral extra-articular tenodesis (LET', 'ACLR+LET', 'anterior cruciate ligament (ACL) reconstruction (ACLR', 'hamstring tendon ACLR with or without LET', 'LET', 'Lateral Extra-articular Tenodesis']","['Marx Activity Rating Scale', 'P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire', 'KOOS pain persisting', 'pain', 'clinical failure', 'graft rupture and persistent rotatory laxity', 'KOOS', 'graft rupture', 'level of sports activity', 'ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C1260974', 'cui_str': 'Tenodesis'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",618.0,0.249471,"The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P  = .11).
","[{'ForeName': 'Alan M J', 'Initials': 'AMJ', 'LastName': 'Getgood', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Dianne M', 'Initials': 'DM', 'LastName': 'Bryant', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Litchfield', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Heard', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'McCormack', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rezansoff', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Peterson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Bardana', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'MacDonald', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Peter C M', 'Initials': 'PCM', 'LastName': 'Verdonk', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Spalding', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Willits', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Birmingham', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hewison', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wanlin', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Firth', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Pinto', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Martindale', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': ""O'Neill"", 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Jennings', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Daniluk', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Dory', 'Initials': 'D', 'LastName': 'Boyer', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mauri', 'Initials': 'M', 'LastName': 'Zomar', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Karyn', 'Initials': 'K', 'LastName': 'Moon', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Raely', 'Initials': 'R', 'LastName': 'Pritchett', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Krystan', 'Initials': 'K', 'LastName': 'Payne', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Mohan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Buchko', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Hiemstra', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kerslake', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tynedal', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Stranges', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Mcrae', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'LeeAnne', 'Initials': 'L', 'LastName': 'Gullett', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Legary', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Longo', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Christian', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Mohtadi', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Rhamona', 'Initials': 'R', 'LastName': 'Barber', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Garven', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Pulsifer', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Mayer', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Simunovic', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Duong', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Skelly', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Ajaykumar', 'Initials': 'A', 'LastName': 'Shanmugaraj', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Howells', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Tough', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Spalding', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Thompson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Metcalfe', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Asplin', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alisen', 'Initials': 'A', 'LastName': 'Dube', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Clarkson', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Brown', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Bolsover', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Belgrove', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Millan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Verdugo', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Dunne', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'McGowan', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Charlie-Marie', 'Initials': 'CM', 'LastName': 'Suddens', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Declercq', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kristien', 'Initials': 'K', 'LastName': 'Vuylsteke', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Haver', 'Affiliation': 'Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada.'}]",The American journal of sports medicine,['10.1177/0363546519896333']
182,31609489,Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study.,"OBJECTIVE


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


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


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


This study has demonstrated the superiority in cleansing efficacy of waist-shaped over cylindric inter-dental brushes in individuals receiving supportive periodontal treatment.",2020,"There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
","['individuals receiving supportive periodontal treatment', 'Seventeen probands with 1,474 tooth sites finished the study', '20 periodontal maintenance patients diagnosed with periodontitis stage 3 were recruited', 'patients receiving supportive periodontal therapy']","['waist-shaped and cylindric interdental brushes', 'waist-shaped interdental brushes', 'waist-shaped versus cylindric interdental brushes']","['Turesky-Quigley Hein plaque index (T-QHI) and the papillary bleeding index (PBI', 'PBI levels of waist-shaped and cylindric brushes', 'T-QHI for waist-shaped interdental brushes', 'median of overall T-QHI scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0702111', 'cui_str': 'Proband (finding)'}, {'cui': 'C0445330', 'cui_str': 'Tooth site (attribute)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205312', 'cui_str': 'Papillary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.156129,"There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schnabl', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Goebel', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kadletz', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gaenzer', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Laimer', 'Affiliation': 'University Hospital of Cranio-Maxillofacial and Oral Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kapferer-Seebacher', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}]",Journal of clinical periodontology,['10.1111/jcpe.13210']
183,31765228,Minimum 10-Year Clinical and Radiological Outcomes of a Randomized Controlled Trial Evaluating 2 Different Approaches to Full Weightbearing After Matrix-Induced Autologous Chondrocyte Implantation.,"BACKGROUND


Longer term outcomes after matrix-induced autologous chondrocyte implantation (MACI) are lacking, while early postoperative weightbearing (WB) management has traditionally been conservative.
PURPOSE


To investigate the longer term clinical and radiological outcomes after an 8-week (vs 12-week) WB protocol after MACI.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


A randomized study design allocated 70 patients to an 8- (n = 34) or 12-week (n = 36) approach to full WB after MACI of the medial or lateral femoral condyle. Patients were evaluated preoperatively; at 3, 12, and 24 months after surgery; and at 5 and 10 years after surgery. At 10 years (range, 10.5-11.5 years), 60 patients (85.7%; 8 weeks: n = 29; 12 weeks: n = 31) were available for review. Clinical outcomes included patient-reported outcomes, maximal isokinetic knee extensor and flexor strength, and functional hop capacity. High-resolution magnetic resonance imaging (MRI) was undertaken to assess the quality and quantity of repair tissue per the MOCART (magnetic resonance observation of cartilage repair tissue) system. A combined MRI composite score was also evaluated.
RESULTS


Clinical and MRI-based scores for the full cohort significantly improved ( P  < .05) over the 10-year period. Apart from the Tegner activity score, which improved ( P  = .041), as well as tissue structure ( P  = .030), which deteriorated, there were no further statistically significant changes ( P  > .05) from 5 to 10 years. There were no 10-year differences between the 2 WB rehabilitation groups. At 10 years, 81.5% and 82.8% of patients in the 8- and 12-week groups, respectively, demonstrated good-excellent tissue infill. Graft failure was observed on MRI at 10 years in 7 patients overall, which included 4 located on 10-year MRI (8 weeks: n = 1; 12 weeks: n = 3) and a further 3 patients (8 weeks: n = 1; 12 weeks: n = 2) not included in the current analysis who proceeded to total knee arthroplasty. At 10 years, 93.3% of patients were satisfied with MACI for relieving their pain, with 83.3% satisfied with their ability to participate in sport.
CONCLUSION


MACI provided high satisfaction levels and tissue durability beyond 10 years. The outcomes of this randomized trial demonstrate a safe 8-week WB rehabilitation protocol without jeopardizing longer term outcomes.",2020,"Apart from the Tegner activity score, which improved ( P  = .041), as well as tissue structure ( P  = .030), which deteriorated, there were no further statistically significant changes ( P  > .05) from 5 to 10 years.","['70 patients to an 8- (n = 34) or 12-week (n = 36', 'At 10 years (range, 10.5-11.5 years), 60 patients (85.7%; 8 weeks: n = 29; 12 weeks: n = 31']","['matrix-induced autologous chondrocyte implantation (MACI', 'Matrix-Induced Autologous Chondrocyte Implantation', 'High-resolution magnetic resonance imaging (MRI', 'MACI', 'approach to full WB after MACI of the medial or lateral femoral condyle', 'Full Weightbearing']","['Graft failure', 'quality and quantity of repair tissue', 'Tegner activity score', 'patient-reported outcomes, maximal isokinetic knee extensor and flexor strength, and functional hop capacity', 'tissue structure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}]","[{'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}]","[{'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}]",70.0,0.12822,"Apart from the Tegner activity score, which improved ( P  = .041), as well as tissue structure ( P  = .030), which deteriorated, there were no further statistically significant changes ( P  > .05) from 5 to 10 years.","[{'ForeName': 'Jay R', 'Initials': 'JR', 'LastName': 'Ebert', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fallon', 'Affiliation': 'Perth Radiological Clinic, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Ackland', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Janes', 'Affiliation': 'Perth Orthopaedic & Sports Medicine Centre, West Perth, Western Australia, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wood', 'Affiliation': 'School of Surgery (Orthopaedics), University of Western Australia, Crawley, Western Australia, Australia.'}]",The American journal of sports medicine,['10.1177/0363546519886548']
184,31144427,A pre-specified statistical analysis plan for the VERIFY study: Vildagliptin efficacy in combination with metformin for early treatment of T2DM.,"AIMS


To ensure the integrity of the planned analyses and maximize the clinical utility of the VERIFY study results by describing the detailed concepts behind its statistical analysis plan (SAP) before completion of data collection and study database lock. The SAP will be adhered to for the final primary data analysis of the VERIFY trial.
MATERIALS AND METHODS


Vildagliptin efficacy in combination with metformin for early treatment of T2DM (VERIFY) is an ongoing, multicentre, randomized controlled trial aiming to demonstrate the clinical benefits of glycaemic durability and glucose control achieved with an early combination therapy in newly-diagnosed type 2 diabetes (T2DM) patients.
RESULTS


The SAP was initially designed at the study protocol conception phase and later modified, as reported here, in collaboration between the steering committee members, statisticians, and the VERIFY study leadership team. All authors were blinded to treatment allocation. An independent statistician has additionally retrieved and presented unblinded data to the independent data safety monitoring committee. An overview of the trial design with a focus on describing the fine-tuning of the analysis plan for the primary efficacy endpoint, risk of initial treatment failure, and secondary, exploratory and pre-specified subgroup analyses is provided here.
CONCLUSION


According to optimal trial practice, the details of the statistical analysis and data-handling plan prior to locking the database are reported here. The SAP accords with high-quality standards of internal validity to minimize analysis bias and will enhance the utility of the reported results for improved outcomes in the management of T2DM.",2019,"An overview of the trial design with a focus on describing the fine-tuning of the analysis plan for the primary efficacy endpoint, risk of initial treatment failure, and secondary, exploratory and pre-specified subgroup analyses is provided here.
",['newly-diagnosed type 2 diabetes (T2DM) patients'],"['glycaemic durability and glucose control achieved with an early combination therapy', 'metformin']",[],"[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],,0.0499542,"An overview of the trial design with a focus on describing the fine-tuning of the analysis plan for the primary efficacy endpoint, risk of initial treatment failure, and secondary, exploratory and pre-specified subgroup analyses is provided here.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Matthews', 'Affiliation': 'Oxford Centre for Diabetes Endocrinology and Metabolism, Radcliffe Department of Medicine, Oxford, UK.'}, {'ForeName': 'Päivi M', 'Initials': 'PM', 'LastName': 'Paldánius', 'Affiliation': 'Department of Cardiovascular Metabolism, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumvoll', 'Affiliation': 'Divisions of Endocrinology and Diabetes, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Clinical Development and Analytics, Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Bader', 'Affiliation': 'Department of Cardiovascular Metabolism, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'YannTong', 'Initials': 'Y', 'LastName': 'Chiang', 'Affiliation': 'Clinical Development and Analytics, Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Department of Cardiovascular Metabolism, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Pisa, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13800']
185,32074256,Effectiveness of Implanted Cardiac Rhythm Recorders With Electrocardiographic Monitoring for Detecting Arrhythmias in Pregnant Women With Symptomatic Arrhythmia and/or Structural Heart Disease: A Randomized Clinical Trial.,"Importance


Arrhythmias are an important cause of maternal morbidity and mortality but remain difficult to diagnose.
Objective


To compare implantable loop recorder (ILR) plus 24-hour Holter electrocardiographic (ECG) monitoring with standard 24-hour Holter ECG monitoring alone in terms of acceptability, ability to identify significant arrythmias, and effect on management and pregnancy outcome in women who were symptomatic or at high risk of arrythmia because of underlying structural heart disease.
Design, Setting, and Participants


This single-center, prospective randomized clinical trial recruited 40 consecutive patients from the Cardiac Disease and Maternity Clinic at Groote Schuur Hospital in Cape Town, South Africa. Pregnant patients with symptoms of arrhythmia and/or structural heart disease at risk of arrhythmia were included.
Intervention


Patients were randomized to standard care (SC; 24-hour Holter ECG monitoring [n = 20]) or standard care plus ILR (SC-ILR; 24-hour Holter ECG monitoring plus ILR [n = 20]). Only 17 consented to ILR insertion, and the 3 who declined ILR were allocated to the SC group.
Main Outcomes and Measures


Arrhythmias considered included atrial fibrillation, atrial flutter, premature ventricular complexes, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation.
Results


Among the 40 women in this trial, the mean (SD) age was 28.4 (5.5) years. Holter monitoring detected arrhythmias in 3 of 23 patients (13%) in the SC group and 4 of 17 patients (24%) in the SC-ILR group compared with 9 of 17 patients (53%) patients who had arrhythmias detected by ILR. Seven patients (4 with supraventricular tachycardia, 1 with premature ventricular complexes, and 2 with paroxysmal atrial fibrillation recorded by ILR) did not have arrhythmias detected by 24-hour Holter monitoring. Three of these 7 patients (43%) had a change in management as a result of their ILR recordings. There were no maternal deaths. However, the SC group had a significantly lower mean (SD) gestational stage at delivery (35 [5] weeks vs 38 [2], P = .04).
Conclusions and Relevance


The ILR was better than 24-hour Holter monitoring in detecting arrhythmias, which led to a change in management for a significant proportion of patients. Our findings suggest that ILR may be beneficial for pregnant women at risk of arrhythmia.
Trial Registration


ClinicalTrials.gov Identifier: NCT02249195.",2020,Holter monitoring detected arrhythmias in 3 of 23 patients (13%) in the SC group and 4 of 17 patients (24%) in the SC-ILR group compared with 9 of 17 patients (53%) patients who had arrhythmias detected by ILR.,"['Pregnant patients with symptoms of arrhythmia and/or structural heart disease at risk of arrhythmia were included', 'Seven patients (4 with supraventricular tachycardia, 1 with premature ventricular complexes, and 2 with paroxysmal atrial fibrillation recorded by ILR) did not have arrhythmias detected by 24-hour Holter monitoring', '40 consecutive patients from the Cardiac Disease and Maternity Clinic at Groote Schuur Hospital in Cape Town, South Africa', 'pregnant women at risk of arrhythmia', 'women who were symptomatic or at high risk of arrythmia because of underlying structural heart disease', '40 women in this trial, the mean (SD) age was 28.4 (5.5) years', 'Only 17 consented to ILR insertion, and the 3 who declined ILR', 'Pregnant Women With Symptomatic Arrhythmia and/or Structural Heart Disease']","['standard care (SC; 24-hour Holter ECG monitoring [n\u2009=\u200920]) or standard care plus ILR (SC-ILR; 24-hour Holter ECG monitoring plus ILR [n\u2009=\u200920', 'ILR', 'implantable loop recorder (ILR) plus 24-hour Holter electrocardiographic (ECG) monitoring with standard 24-hour Holter ECG monitoring alone', 'Implanted Cardiac Rhythm Recorders With Electrocardiographic Monitoring']","['Main Outcomes and Measures\n\n\nArrhythmias considered included atrial fibrillation, atrial flutter, premature ventricular complexes, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation', 'Holter monitoring detected arrhythmias', 'maternal deaths', 'mean (SD) gestational stage at delivery']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C0151636', 'cui_str': 'Ventricular Ectopic Beats'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C1274026', 'cui_str': 'Maternity clinic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4552498', 'cui_str': 'Implantable loop recorder'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0182913', 'cui_str': 'Recorder'}]","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0151636', 'cui_str': 'Ventricular Ectopic Beats'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia (disorder)'}, {'cui': 'C0042514', 'cui_str': 'Tachycardia, Ventricular'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",40.0,0.113759,Holter monitoring detected arrhythmias in 3 of 23 patients (13%) in the SC group and 4 of 17 patients (24%) in the SC-ILR group compared with 9 of 17 patients (53%) patients who had arrhythmias detected by ILR.,"[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sliwa', 'Affiliation': 'Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Feriel', 'Initials': 'F', 'LastName': 'Azibani', 'Affiliation': 'Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Johnson', 'Affiliation': 'Imperial College London, Chelsea and Westminster Hospital, London, United Kingdom.'}, {'ForeName': 'Charle', 'Initials': 'C', 'LastName': 'Viljoen', 'Affiliation': 'Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Baard', 'Affiliation': 'Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ayesha', 'Initials': 'A', 'LastName': 'Osman', 'Affiliation': 'Division of Obstetrics and Gynecology, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Briton', 'Affiliation': 'Hatter Institute for Cardiovascular Research in Africa, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mpiko', 'Initials': 'M', 'LastName': 'Ntsekhe', 'Affiliation': 'Division of Cardiology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Chin', 'Affiliation': 'Division of Cardiology, Department of Medicine, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa.'}]",JAMA cardiology,['10.1001/jamacardio.2019.5963']
186,31168921,Incorporating and interpreting regulatory guidance on estimands in diabetes clinical trials: The PIONEER 1 randomized clinical trial as an example.,"Regulatory guidelines describe the use of estimands in designing and conducting clinical trials. Estimands ensure alignment of the objectives with the design, conduct and analysis of a trial. An estimand is defined by four inter-related attributes: the population of interest, the variable (endpoint) of interest, the way intercurrent events are handled and the population level summary. A trial may employ multiple estimands to evaluate treatment effects from different perspectives in order to address different scientific questions. As estimands may be an unfamiliar concept for many clinicians treating diabetes, this paper reviews the estimand concept and uses the PIONEER 1 phase 3a clinical trial, which investigated the efficacy and safety of oral semaglutide vs placebo, as an example of the way in which estimands can be implemented and interpreted. In the PIONEER 1 trial, two estimands were employed for each efficacy endpoint and were labelled as: (a) the treatment policy estimand, used to assess the treatment effect regardless of use of rescue medication or discontinuation of trial product, and provides a broad perspective of the treatment effect in the population of patients with type 2 diabetes in clinical practice; and (b) the trial product estimand, used to assess the treatment effect if all patients had continued to use trial product for the planned duration of the trial without rescue medication, thereby providing information on the anticipated treatment effect of the medication. Both approaches are complementary to understanding the effect of the studied treatments.",2019,"In the PIONEER 1 trial, two estimands were employed for each efficacy endpoint and were labelled as: (a) the treatment policy estimand, used to assess the treatment effect regardless of use of rescue medication or discontinuation of trial product, and provides a broad perspective of the treatment effect in the population of patients with type 2 diabetes in clinical practice; and (b) the trial product estimand, used to assess the treatment effect if all patients had continued to use trial product for the planned duration of the trial without rescue medication, thereby providing information on the anticipated treatment effect of the medication.",['patients with type 2 diabetes in clinical practice'],['placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],2.0,0.0627142,"In the PIONEER 1 trial, two estimands were employed for each efficacy endpoint and were labelled as: (a) the treatment policy estimand, used to assess the treatment effect regardless of use of rescue medication or discontinuation of trial product, and provides a broad perspective of the treatment effect in the population of patients with type 2 diabetes in clinical practice; and (b) the trial product estimand, used to assess the treatment effect if all patients had continued to use trial product for the planned duration of the trial without rescue medication, thereby providing information on the anticipated treatment effect of the medication.","[{'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Department of Medicine, Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Saugstrup', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism, Diabetes Care Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Donsmark', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jeppe', 'Initials': 'J', 'LastName': 'Zacho', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Department of Health Sciences, Diabetes Research Centre, University of Leicester, Leicester, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13804']
187,31168922,Type 2 diabetes remission 1 year after an intensive lifestyle intervention: A secondary analysis of a randomized clinical trial.,"AIM


To investigate whether an intensive lifestyle intervention induces partial or complete type 2 diabetes (T2D) remission.
MATERIALS AND METHODS


In a secondary analysis of a randomized, assessor-blinded, single-centre trial, people with non-insulin-dependent T2D (duration <10 years), were randomly assigned (2:1, stratified by sex, from April 2015 to August 2016) to a lifestyle intervention group (n = 64) or a standard care group (n = 34). The primary outcome was partial or complete T2D remission, defined as non-diabetic glycaemia with no glucose-lowering medication at the outcome assessments at both 12 and 24 months from baseline. All participants received standard care, with standardized, blinded, target-driven medical therapy during the initial 12 months. The lifestyle intervention included 5- to 6-weekly aerobic and combined aerobic and strength training sessions (30-60 minutes) and individual dietary plans aiming for body mass index ≤25 kg/m 2  . No intervention was provided during the 12-month follow-up period.
RESULTS


Of the 98 randomized participants, 93 completed follow-up (mean [SD] age 54.6 [8.9] years; 46 women [43%], mean [SD] baseline glycated haemoglobin 49.3 [9.3] mmol/mol). At follow-up, 23% of participants (n = 14) in the intervention and 7% (n = 2) in the standard care group met the criteria for any T2D remission (odds ratio [OR] 4.4, 95% confidence interval [CI] 0.8-21.4]; P = 0.08). Assuming participants lost to follow-up (n = 5) had relapsed, the OR for T2D remission was 4.4 (95% CI 1.0-19.8; P = 0.048).
CONCLUSIONS


The statistically nonsignificant threefold increased remission rate of T2D in the lifestyle intervention group calls for further large-scale studies to understand how to implement sustainable lifestyle interventions among people with T2D.",2019,The primary outcome was partial or complete,"['people with non-insulin-dependent T2D (duration <10\u2009years', '8.9] years; 46 women [43%], mean [SD] baseline glycated haemoglobin 49.3 [9.3] mmol/mol', 'people with T2D', 'Of the 98 randomized participants, 93 completed follow-up (mean [SD] age 54.6']","['lifestyle intervention included 5- to 6-weekly aerobic and combined aerobic and strength training sessions (30-60\u2009minutes) and individual dietary plans aiming for body mass index ≤25\u2009kg/m 2  ', 'standard care group', 'lifestyle intervention group', 'intensive lifestyle intervention']","['T2D remission', 'OR for T2D remission', 'partial or complete', 'remission rate of T2D', 'T2D remission, defined as non-diabetic glycaemia with no glucose-lowering medication', 'partial or complete type 2 diabetes (T2D) remission']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",98.0,0.103946,The primary outcome was partial or complete,"[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mette Y', 'Initials': 'MY', 'LastName': 'Johansen', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'MacDonald', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Hansen', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nanna Skytt', 'Initials': 'NS', 'LastName': 'Pilmark', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Section of Social Medicine, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Allan A', 'Initials': 'AA', 'LastName': 'Vaag', 'Affiliation': 'Cardiovascular and Metabolic Disease Translational Medicine Unit, Early Clinical Development, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'Centre of Inflammation and Metabolism and Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13802']
188,31173451,Efficacy of two telemonitoring systems to improve glycaemic control during basal insulin initiation in patients with type 2 diabetes: The TeleDiab-2 randomized controlled trial.,"TeleDiab-2 was a 13-month randomized controlled trial evaluating the efficacy and safety of two telemonitoring systems to optimize basal insulin (BI) initiation in subjects with inadequately controlled type 2 diabetes (HbA1c, 7.5%-10%). A total of 191 participants (mean age 58.7 years, mean HbA1c 8.9%) were randomized into three groups: group 1(G1, standard care, n = 63), group 2 (G2, interactive voice response system, n = 64) and group 3 (G3, Diabeo-BI app software, n = 64). The two telemonitoring systems proposed daily adjustments of BI doses, in order to facilitate the achievement of fasting blood glucose (FBG) values targeted at ~100 mg/dL. At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: -1.44% and G3: -1.48% vs. G1: -0.92%; P < 0.002). Moreover, target FBG was reached by twice as many patients in the telemonitoring groups as in the control group, and insulin doses were also titrated to higher levels. No severe hypoglycaemia was observed in the telemonitoring groups and mild hypoglycaemia frequency was similar in all groups. In conclusion, both telemonitoring systems improved glycaemic control to a similar extent, without increasing hypoglycaemic episodes.",2019,"mg/dL. At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: -1.44% and G3: -1.48% vs. G1: -0.92%; P < 0.002).","['subjects with inadequately controlled type 2 diabetes (HbA1c, 7.5%-10', 'patients with type 2 diabetes', '191 participants (mean age 58.7 years, mean HbA1c 8.9']",['two telemonitoring systems to optimize basal insulin (BI) initiation'],"['fasting blood glucose (FBG) values', 'mild hypoglycaemia frequency', 'HbA1c reduction', 'glycaemic control', 'hypoglycaemic episodes', 'efficacy and safety', 'severe hypoglycaemia', 'target FBG']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",191.0,0.0502008,"mg/dL. At 4 months follow-up, HbA1c reduction was significantly higher in the telemonitoring groups (G2: -1.44% and G3: -1.48% vs. G1: -0.92%; P < 0.002).","[{'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Franc', 'Affiliation': 'CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joubert', 'Affiliation': 'Diabetes Care Unit, Caen University Hospital, Caen, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Daoudi', 'Affiliation': 'CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Fagour', 'Affiliation': 'Department of Diabetology and Endocrinology, Fort-de-France University Hospital, Fort de France, France.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Benhamou', 'Affiliation': 'Department of Diabetology, Endocrinology and Nutrition Diseases, Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rodier', 'Affiliation': 'Department of Metabolic Diseases and Endocrinology, Nimes University Hospital, Nimes, France.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Boucherie', 'Affiliation': 'CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Benamo', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Avignon University Hospital, Avignon, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Schaepelynck', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolic Diseases, Marseille University Hospital, Marseille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Dured', 'Initials': 'D', 'LastName': 'Dardari', 'Affiliation': 'CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Borot', 'Affiliation': 'Department of Diabetology and Endocrinology, Besançon University Hospital, Besançon, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': 'Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': ""D'Orsay"", 'Affiliation': 'Voluntis, Suresnes, Paris, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Mari', 'Affiliation': ""Randomised Clinical Trials (RCTs') Department of Statistics, Lyon, France.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Reznik', 'Affiliation': 'Diabetes Care Unit, Caen University Hospital, Caen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Randazzo', 'Affiliation': 'CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Charpentier', 'Affiliation': 'CERITD (Centre for Studies and Research for the Intensification of Diabetes Treatment), Bioparc Genopole Campus, Evry, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13806']
189,31173455,"Efficacy and safety of ipragliflozin add-on therapy to insulin in Japanese patients with type 1 diabetes mellitus: A randomized, double-blind, phase 3 trial.","AIM


To assess the efficacy and safety of once-daily ipragliflozin 50 mg versus placebo in Japanese people with type 1 diabetes mellitus (T1DM) inadequately controlled with insulin.
MATERIALS AND METHODS


We conducted a multicentre, double-blind, parallel-group, placebo-controlled phase 3 study. Participants (N = 175) were randomized (2:1) to receive once-daily ipragliflozin 50 mg (n = 115) or placebo (n = 60), combined with insulin, for 24 weeks. The primary endpoint was change in glycated haemoglobin (HbA1c); key secondary endpoints included change in insulin dose and body weight. Treatment-emergent adverse events (TEAEs) were evaluated.
RESULTS


The ipragliflozin group demonstrated a significant decrease in HbA1c from baseline to end of treatment versus the placebo group: adjusted mean difference (AMD) -3.8 mmol/mol (95% confidence interval [CI] -6.2, -1.5) or - 0.36% (95% CI -0.57, -0.14; P = 0.001). Significant reductions in total daily insulin dose (AMD -7.35 IU [95% CI -9.09, -5.61]; P < 0.001) and body weight (AMD -2.87 kg [95% CI -3.58, -2.16]; P < 0.001) were observed for the ipragliflozin group versus placebo. Two serious TEAEs occurred (major hypoglycaemia and abdominal abscess); both were in the placebo group. All other TEAEs were mild or moderate in severity. Four cases of study discontinuation occurred; three in the placebo group and one in the ipragliflozin group. No diabetic ketoacidosis was reported for any participant in this study.
CONCLUSIONS


Daily ipragliflozin 50 mg in combination with insulin significantly reduced HbA1c, daily insulin dose and body weight versus placebo in people with T1DM. No safety concerns were identified after 24 weeks of treatment. Overall, once-daily ipragliflozin 50 mg was both efficacious and well tolerated.",2019,"Daily 50-mg ipragliflozin in combination with insulin significantly reduced HbA1c, daily insulin dose, and body weight versus placebo in patients with T1DM.","['Japanese patients with type 1 diabetes mellitus (T1DM) inadequately controlled with insulin', 'Japanese patients with type 1 diabetes mellitus', 'Patients (N=175', 'patients with T1DM']","['placebo', 'ipragliflozin versus placebo', 'ipragliflozin']","['efficacious and well tolerated', 'diabetic ketoacidosis', 'HbA1c, daily insulin dose, and body weight', 'HbA1c', 'Efficacy and safety', 'efficacy and safety', 'total daily insulin dose', 'glycated hemoglobin (HbA1c); key secondary endpoints included change in insulin dose and body weight', 'body weight']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}]","[{'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2959938', 'cui_str': 'Change in insulin dose (procedure)'}]",175.0,0.797644,"Daily 50-mg ipragliflozin in combination with insulin significantly reduced HbA1c, daily insulin dose, and body weight versus placebo in patients with T1DM.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Department of Medicine, Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isaka', 'Affiliation': 'Japan/Asia Clinical Development, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Sakatani', 'Affiliation': 'Data Science, Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Clinical Pharmacology and Exploratory Development, Astellas Pharma Inc., Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13807']
190,31863284,"The Effect of Rifampin on the Pharmacokinetics and Safety of Lorlatinib: Results of a Phase One, Open-Label, Crossover Study in Healthy Participants.","INTRODUCTION


Lorlatinib is a third-generation tyrosine kinase inhibitor approved for the treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer; cytochrome P450 (CYP) 3A plays an important role in the metabolism of lorlatinib.
METHODS


This phase 1, open-label, two-period, crossover study estimated the effect of oral rifampin (a strong CYP3A inducer) on the pharmacokinetics and safety of oral lorlatinib (NCT02804399). Healthy participants received single-dose lorlatinib 100 mg in period 1 followed by rifampin 600 mg/day (days 1-12) and single-dose lorlatinib 100 mg (day 8) in period 2. Blood samples were collected for 120 h after each dose of lorlatinib.
RESULTS


When a single dose of lorlatinib was administered during daily dosing with rifampin (period 2), the area under the plasma concentration-time profile extrapolated to infinity (AUC inf ) and maximum plasma concentration (C max ) of lorlatinib were 14.74% [90% confidence interval (CI) 12.78%, 17.01%] and 23.88% (90% CI 21.58%, 26.43%), respectively, of those in period 1 (lorlatinib alone). A single dose of lorlatinib was well tolerated in period 1, but elevations in transaminase values were observed in all participants (grade 2-4 in 11 participants) within 1-3 days after a single dose of lorlatinib was administered with ongoing rifampin in period 2. Rifampin dosing was therefore halted. Transaminase levels subsequently returned to normal (median time to recovery: 15 days). No elevations in bilirubin were observed.
CONCLUSIONS


The addition of a single dose of lorlatinib to daily dosing with rifampin significantly reduced lorlatinib plasma exposure relative to a single dose of lorlatinib administered alone and was associated with severe but self-limiting transaminase elevations in all healthy participants. These observations support the contraindication in the product label against concomitant use of lorlatinib with all strong CYP3A inducers.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02804399.",2020,"No elevations in bilirubin were observed.
","['Healthy Participants', 'Healthy participants received']","['single-dose lorlatinib 100\xa0mg in period 1 followed by rifampin', 'Rifampin', 'rifampin', 'rifampin (period 2', 'oral rifampin', 'Lorlatinib']","['Blood samples', 'area under the plasma concentration-time profile extrapolated to infinity (AUC inf ) and maximum plasma concentration (C max ) of lorlatinib', 'transaminase values', 'lorlatinib plasma exposure relative', 'bilirubin', 'Transaminase levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4080091'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4080091'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",11.0,0.20004,"No elevations in bilirubin were observed.
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Global Product Development, Pfizer Oncology, New York, NY, USA. joseph.chen@pfizer.com.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Pawlak', 'Affiliation': 'Global Product Development, Pfizer Inc., New Haven, CT, USA.'}, {'ForeName': 'Leonard P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': 'Global Product Development, Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Peltz', 'Affiliation': 'Safety Surveillance and Risk Management, Pfizer Oncology, Groton, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ginman', 'Affiliation': 'Global Product Development, Pfizer Inc., South Lyon, MI, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bergeron', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.'}]",Advances in therapy,['10.1007/s12325-019-01198-9']
191,32297754,"Evaluating a longitudinal mediation model of perceived stress, depressive symptoms, and substance use treatment outcomes.","The allostatic model of addiction suggests that negative affect, such as depressive symptoms, mediates the effect of stress on outcomes among individuals with substance use disorders. However, few longitudinal treatment studies have demonstrated this effect. We analyzed data from a 12-week randomized trial of galantamine and/or computerized cognitive-behavioral therapy (CBT4CBT) for individuals ( N  = 120) with cocaine use disorder in methadone treatment for opioid use disorder. We evaluated baseline perceived stress as a predictor of end-of-treatment (EOT) substance use outcomes, and EOT perceived stress as a predictor of month 6 posttreatment outcomes. We conducted mediation models with intervening depressive symptoms as a mediator. We also explored whether CBT4CBT moderated the effects of perceived stress. Baseline perceived stress did not predict EOT outcomes (i.e., total effect). However, in mediation models, we found indirect effects of baseline perceived stress on EOT cocaine and illicit opioid use, via midtreatment depressive symptoms. EOT perceived stress had significant total effects on month 6 cocaine and illicit opioid use, and an indirect effect on month 6 illicit opioid use (but not cocaine use), via month 3 depressive symptoms. Alternative models with depressive symptoms as the predictor and perceived stress as a mediator revealed no indirect effects. The addition of CBT4CBT to standard methadone treatment did not moderate total or indirect effects of perceived stress on substance use. Depressive symptoms may play a mediating role in the prospective indirect effect of perceived stress on substance use outcomes, particularly illicit opioid use. Further research is needed on therapies targeting stress. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The addition of CBT4CBT to standard methadone treatment did not moderate total or indirect effects of perceived stress on substance use.,"['individuals with substance use disorders', 'individuals ( N  = 120) with cocaine use disorder in methadone treatment for opioid use disorder']","['galantamine and/or computerized cognitive-behavioral therapy (CBT4CBT', 'CBT4CBT']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}]",[],,0.0295321,The addition of CBT4CBT to standard methadone treatment did not moderate total or indirect effects of perceived stress on substance use.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Division of Alcohol and Drug Abuse.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Department of Psychiatry.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000581']
192,31836949,Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma.,"INTRODUCTION


For patients with eosinophilic asthma with allergic characteristics, understanding the key drivers of exacerbations is important to identify optimal treatment strategies. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody that significantly reduces exacerbation frequency for patients with severe, uncontrolled eosinophilic asthma. We evaluated the predictive value of baseline blood eosinophil counts vs. serum immunoglobulin E (IgE) concentrations on exacerbation risk and the association of these variables with benralizumab treatment effect.
METHODS


Analyses were performed with data pooled from the phase III SIROCCO and CALIMA benralizumab trials. Crude annual asthma exacerbation rates (AERs) were determined for placebo as a function of baseline blood eosinophil counts and serum IgE concentrations with prespecified blood eosinophil count categories (< 150, ≥ 150 to < 300, ≥ 300 to < 450, ≥ 450 cells/µL) and IgE concentration quartiles (< 62.0, ≥ 62.0 to < 176.2, ≥ 176.2 to < 453.4, and ≥ 453.4 kU/L). We compared AERs for patients receiving benralizumab 30 mg every 8 weeks (first three doses every 4 weeks) vs. placebo for overlapping baseline blood eosinophil count categories and serum IgE concentration quartiles via a regression approach and by continuously using locally weighted regression smoothing analysis.
RESULTS


Exacerbation risk for patients with severe asthma receiving placebo increased with increasing baseline blood eosinophil counts but not with increasing serum IgE concentrations. Addition of baseline atopy status did not influence the relationship between IgE concentrations and exacerbation risk for patients receiving placebo. Patients with blood eosinophil counts ≥ 300 cells/µL had consistent decreases in exacerbation risk with benralizumab relative to placebo across all serum IgE concentration quartiles.
CONCLUSION


Baseline blood eosinophil counts, but not serum IgE concentrations, are an important predictor of exacerbation risk. Patients with severe eosinophilic asthma treated with benralizumab had consistent reductions in exacerbation risk, regardless of IgE concentrations.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov: SIROCCO, NCT01928771; CALIMA, NCT01914757.",2020,"300 cells/µL had consistent decreases in exacerbation risk with benralizumab relative to placebo across all serum IgE concentration quartiles.
","['Patients with Severe Eosinophilic Asthma', 'Patients with severe eosinophilic asthma treated with', 'patients with severe, uncontrolled eosinophilic asthma', 'patients with severe asthma receiving', 'patients with eosinophilic asthma with allergic characteristics', 'Patients with blood eosinophil counts ≥']","['placebo', 'benralizumab', 'Benralizumab']","['IgE concentration quartiles', 'exacerbation risk, regardless of IgE concentrations', 'IgE concentrations and exacerbation risk', 'exacerbation risk', 'Crude annual asthma exacerbation rates (AERs', 'Baseline blood eosinophil counts', 'baseline blood eosinophil counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2982078', 'cui_str': 'benralizumab'}]","[{'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.197062,"300 cells/µL had consistent decreases in exacerbation risk with benralizumab relative to placebo across all serum IgE concentration quartiles.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Jackson', 'Affiliation': ""Guy's Severe Asthma Centre, Guy's & St Thomas' NHS Trust, Great Maze Pond, London, UK. David.Jackson@gstt.nhs.uk.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'AP-HP, Service de Pneumologie, Hôpital Bicêtre, 78 Rue du Général Leclerc, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hirsch', 'Affiliation': 'AstraZeneca, One MedImmune Way, Gaithersburg, MD, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newbold', 'Affiliation': 'AstraZeneca, One MedImmune Way, Gaithersburg, MD, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Garcia Gil', 'Affiliation': 'AstraZeneca, Avgda. Diagonal, Barcelona, Spain.'}]",Advances in therapy,['10.1007/s12325-019-01191-2']
193,32297279,Feasibility and Outcome of a Phase II Study of Intensive Induction Chemotherapy in 91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment.,"INTRODUCTION


We prospectively tested in a phase II study high-dose aracytin and idarubicin plus amifostine as induction regimen in 149 patients with acute myeloid leukaemia (AML) aged ≥ 60 years, evaluated by a simplified multidimensional geriatric assessment (MGA).
METHODS


Ninety-one fully or partially fit patients (61%) were allocated to intensive chemotherapy and 58 (39%) frail patients to best supportive care (BSC). Intensively treated patients, showing early death and complete response (CR) rate respectively of 5.5% and 73.6%, received 61 consolidations, followed by autologous transplant (ASCT), stem cell transplantation (SCT) or gemtuzumab ozogamicin, depending on mobilization outcome and donor availability.
RESULTS


The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001). Hyperleukocytosis and cytogenetics were predictors of survival with a relative risk of 1.8 in patients with poor karyotype without hyperleukocytosis (p = 0.02) and 3 in those with hyperleukocytosis (≥ 50,000/μl) (p = 0.002).
CONCLUSION


MGA allowed tailored post-consolidation in 53.8% of patients after high-dose aracytin induction, with long-term survival doubling that reported in the literature after standard-dose cytarabine regimens.
TRIAL REGISTRATION


The study was registered with the Umin Clinical Trial Registry (www.umin.ac.jp/ctr), number R000014052.",2020,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","['149 patients with acute myeloid leukaemia (AML) aged ≥', '91 Elderly Patients with AML Evaluated Using a Simplified Multidimensional Geriatric Assessment', 'Ninety-one fully or partially fit patients (61', 'and 58 (39%) frail patients to best supportive care (BSC']","['Intensive Induction Chemotherapy', 'MGA', 'intensive chemotherapy', 'aracytin and idarubicin plus amifostine']","['8-year overall survival (OS', 'early death and complete response (CR) rate']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015020', 'cui_str': 'Amifostine'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",149.0,0.066301,"The 8-year overall survival (OS) of these patients was 20.4%, with median duration of 11.4 months significantly superior to the 1.5 months of BSC arm (p < 0.001).","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Capelli', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy. debora.capelli@ospedaliriuniti.marche.it.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Saraceni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fiorentini', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Chiarucci', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Menotti', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Poloni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Discepoli', 'Affiliation': 'Cytogenetic Laboratory, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Ospedale Salesi, via F. Corridoni, 11, 60100, Ancona, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Leoni', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Olivieri', 'Affiliation': 'Hematology Department, University of Ancona, Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, Via Conca 71, 60126, Ancona, Italy.'}]",Advances in therapy,['10.1007/s12325-020-01310-4']
194,32297283,OPADIA Study: Is a Patient Questionnaire Useful for Enhancing Physician-Patient Shared Decision Making on Physical Activity Micro-objectives in Diabetes?,"INTRODUCTION


Regular physical activity (PA) is recommended by all type 2 diabetes mellitus (T2DM) management guidelines. The OPADIA study aimed to determine whether using a specific patient questionnaire (Optima-PA©) could help T2DM patients increase their PA by leading to better physician-patient communication and improved levels of shared decision making concerning Specific, Measurable, Acceptable, Realistic, Timely (SMART)-PA micro-objectives.
METHODS


Physicians participating in this multicentre, prospective, randomised, real-life study were allocated to a standard group (T2DM patients managed according to usual clinical practice, n = 24) or the OPTIMA-PA group (additional use of the questionnaire, n = 30). The main outcome was the percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective. Other outcomes were the impact of the OPTIMA-PA questionnaire on patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels over a 3-month period (IPAQ-SF scores).
RESULTS


One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group. Unexpectedly, more inclusion visits ended with SMART-PA micro-objectives being set up in the standard group (p < 0.001): 81.1% (n = 99/122) versus 59.7% (n = 80/134). However, fewer patients in the OPTIMA-PA group felt that GPs made decisions alone (32% versus 60%; p < 0.0001). Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
CONCLUSION


Although the OPTIMA-PA questionnaire did not directly promote setting up of SMART-PA micro-objectives in T2DM patients, the OPADIA study demonstrated that this tool was effective at improving patient-physician relationships by increasing patient involvement in therapeutic decision making. Our study also highlighted the importance of GP aptitude for patient-centredness for improving PA in T2DM patients.",2020,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","['Physicians participating in this multicentre', 'T2DM patients', 'One hundred twenty-two patients were included in the standard group and 134 in the OPTIMA-PA group']","['standard group (T2DM patients managed according to usual clinical practice, n\u2009=\u200924) or the OPTIMA-PA', 'Regular physical activity (PA']","['percentage of inclusion visits ending with the setting up of at least one SMART-PA micro-objective', 'patient perceptions of shared decision making (ENTRED questionnaire) and the impact of the OPTIMA-PA questionnaire and establishing SMART-PA micro-objectives as well as patient-perceived physician empathy (ENTRED questionnaire) and GP aptitude for patient-centredness (SEPCQ scores) on patient PA levels']","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0003646', 'cui_str': 'Aptitude'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",122.0,0.0234986,"Positive correlations were also observed between GP patient-centredness and patient-perceived GP empathy or increased patient PA over the study period.
","[{'ForeName': 'Silla M', 'Initials': 'SM', 'LastName': 'Consoli', 'Affiliation': 'Paris Descartes University of Medicine, Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University-Hospital (CHU), G. Montpied Hospital, INRA, UMR 1019, UNH, CRNH Auvergne, Clermont University, University of Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Grimaldi', 'Affiliation': 'Service de diabétologie, Institut E3M, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': ""Service d'endocrinologie, diabétologie et maladies métaboliques, Centre Hospitalier Sud-Francilien de Corbeil-Essonnes, Université Paris-Saclay, Orsay, France.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bineau', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sabin', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Pouriel', 'Affiliation': 'Kappa Santé, 4 rue de Cléry, 75002, Paris, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Freund', 'Affiliation': 'Clintec International SARL, Tour D2, 17 bis place des Reflets, 92099, La Défense, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Dejager', 'Affiliation': 'MSD France, Immeuble Carré Michelet, 10/12 Cours Michelet, 92800, Puteaux, France. sylvie.dejager@msd.com.'}]",Advances in therapy,['10.1007/s12325-020-01336-8']
195,31215727,Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials.,"AIM


To investigate treatment satisfaction with semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, versus placebo/active comparators in the SUSTAIN clinical trial programme.
METHODS


In SUSTAIN 2-5 and 7, the Diabetes Treatment Satisfaction Questionnaire was used to evaluate patient-perceived treatment satisfaction, hyperglycaemia and hypoglycaemia. Post hoc subgroup analyses were conducted to explore the effects of gastrointestinal adverse events (GI AEs), weight loss (≥5%) or achieving glycaemic (HbA1c < 7%) targets on treatment satisfaction.
RESULTS


Overall treatment satisfaction increased from baseline to end of treatment with all treatments across trials. Improvements were significantly greater with semaglutide versus comparators/placebo in SUSTAIN 2-5 (all P < 0.05), and generally greater in patients who achieved versus did not achieve weight loss and glycaemic targets, often with greater improvements with semaglutide 1.0 mg versus comparator/placebo in both weight loss groups. In SUSTAIN 7, improvements in overall treatment satisfaction were generally similar between semaglutide and dulaglutide, irrespective of weight loss or glycaemic control. In SUSTAIN 7, changes in overall treatment satisfaction score were generally lower in patients with versus without GI AEs at week 16 (except dulaglutide 0.75 mg), but similar by week 40. Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all P < 0.05). No differences between treatments were observed for perceived hypoglycaemia.
CONCLUSIONS


Semaglutide was associated with significantly greater (SUSTAIN 2-5) or similar (SUSTAIN 7) improvements in overall treatment satisfaction versus comparators/placebo. Improvements in overall treatment satisfaction were generally greater in patients achieving versus not achieving treatment targets. Clinicaltrials.gov: NCT01930188 (SUSTAIN 2), NCT01885208 (SUSTAIN 3), NCT02128932 (SUSTAIN 4), NCT02305381 (SUSTAIN 5) and NCT02648204 (SUSTAIN 7). EudraCT: 2012-004827-19 (SUSTAIN 2), 2012-004826-92 (SUSTAIN 3), 2013-004392-12 (SUSTAIN 4), 2013-004502-26 (SUSTAIN 5) and 2014-005375-91 (SUSTAIN 7).",2019,Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all p<0.05).,['patients with type 2 diabetes'],"['placebo', 'glucagon-like peptide-1 (GLP-1) receptor agonist, versus placebo']","['perceived hypoglycaemia', 'overall treatment satisfaction', 'treatment satisfaction, hyperglycaemia and hypoglycaemia', 'gastrointestinal adverse events (GI AEs), weight loss (≥5%) or achieving glycaemic (HbA 1c  <7%) targets on treatment satisfaction', 'weight loss and glycaemic targets', 'overall treatment satisfaction score', 'Perceived hyperglycaemia', 'Diabetes Treatment Satisfaction Questionnaire', 'weight loss or glycaemic control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire (assessment scale)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.13698,Perceived hyperglycaemia was significantly reduced from baseline to end of treatment with semaglutide versus all comparators/placebo (all p<0.05).,"[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jendle', 'Affiliation': 'Diabetes Endocrinology and Metabolism Research Center, School of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Department of Medicine III, Carl Gustav Carus University Hospital, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Polonsky', 'Affiliation': 'Behavioral Diabetes Institute, University of California San Diego, San Diego, California.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silver', 'Affiliation': 'Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Uusinarkaus', 'Affiliation': 'DaVita Medical Group, University of Colorado School of Medicine, Colorado Springs, Colorado.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Håkan-Bloch', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13816']
196,31305011,"Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial.","BACKGROUND


Cervical cancer is a major public health concern in China. We report the end-of-study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04-human papillomavirus (HPV)-16/18 vaccine in Chinese women aged 18-25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported.
METHODS


Healthy 18-25-year-old women (N = 6051) were randomized (1:1) to receive three doses of AS04-HPV-16/18 vaccine or Al(OH) 3  (control) at Months 0-1-6. Vaccine efficacy against HPV-16/18 infection and cervical intraepithelial neoplasia (CIN), cross-protective vaccine efficacy against infections and lesions associated with nonvaccine oncogenic HPV types, immunogenicity, and safety were assessed. Efficacy was assessed in the according-to-protocol efficacy (ATP-E) cohort (vaccine N = 2888; control N = 2892), total vaccinated cohort for efficacy (TVC-E; vaccine N = 2987; control N = 2985) and TVC-naïve (vaccine N = 1660; control N = 1587).
RESULTS


In initially HPV-16/18 seronegative/DNA-negative women, vaccine efficacy against HPV-16/18-associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP-E, 88.7% (95% CI: 18.5, 99.7) in the TVC-E, and 100% (95% CI: 17.9, 100) in the TVC-naïve. Cross-protective efficacy against incident infection with HPV-31, HPV-33 and HPV-45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP-E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti-HPV-16/18 antibodies; anti-HPV-16 and anti-HPV-18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group.
CONCLUSIONS


This is the first large-scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China.
TRIAL REGISTRATION


NCT00779766.",2019,High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72.,"['Chinese women aged 18-25\xa0years', 'Healthy 18-25-year-old women (N\xa0=\xa06051', 'Chinese women aged 18-25\xa0years followed for up to 72\xa0months after first vaccination']","['prophylactic HPV vaccination', 'total vaccinated cohort for efficacy (TVC-E; vaccine N\xa0=\xa02987; control N\xa0=\xa02985) and TVC-naïve (vaccine N\xa0=\xa01660; control N\xa0=\xa01587', 'AS04-human papillomavirus (HPV)-16/18 vaccine', 'AS04-HPV-16/18 vaccine', 'HPV vaccine', 'AS04-HPV-16/18 vaccine or Al(OH) 3  (control) at Months 0-1-6']","['Efficacy, immunogenicity and safety', 'New onset autoimmune disease', 'efficacy, immunogenicity, and safety', 'Vaccine efficacy against HPV-16/18 infection and cervical intraepithelial neoplasia (CIN', 'Serious adverse events', 'high burden of HPV infection and cervical cancer', 'Efficacy']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]",,0.449819,High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72.,"[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Shang-Ying', 'Initials': 'SY', 'LastName': 'Hu', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Qin-Jing', 'Initials': 'QJ', 'LastName': 'Pan', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Fang-Hui', 'Initials': 'FH', 'LastName': 'Zhao', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Cheng-Fu', 'Initials': 'CF', 'LastName': 'Zhang', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Jintan Center for Disease Prevention and Control, Jintan, China.'}, {'ForeName': 'Jia-Xi', 'Initials': 'JX', 'LastName': 'Yu', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Yejiang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Binhai Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Changrong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Jintan Center for Disease Prevention and Control, Jintan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Shiyin', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Yan-Shu', 'Initials': 'YS', 'LastName': 'Zhang', 'Affiliation': 'Binhai Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Yunkun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'GSK, Shanghai, China.'}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'GSK, Shanghai, China.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karkada', 'Affiliation': 'GSK, Bangalore, India.'}, {'ForeName': 'Pemmaraju', 'Initials': 'P', 'LastName': 'Suryakiran', 'Affiliation': 'GSK, Bangalore, India.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Wavre, Belgium.'}]",Cancer medicine,['10.1002/cam4.2399']
197,30420291,Evidence of muscle loss delay and improvement of hyperinsulinemia and insulin resistance in Duchenne muscular dystrophy supplemented with omega-3 fatty acids: A randomized study.,"BACKGROUND & AIMS


Duchenne Muscular Dystrophy (DMD) is the most prevalent dystrophy of childhood and is characterized by generalized motor delays due to progressive muscular weakness, leading to loss of muscle mass. Additionally, patients with DMD develop obesity, hyperinsulinemia, and Insulin Resistance (IR). Omega-3 Long-Chain PolyUnsaturated Fatty Acids (Ω-3LCPUFA) increase fat mass, decrease lean mass, and decrease hyperinsulinemia and IR. The aim of this study was to analyze the impact of Ω-3LCPUFA consumption on lean mass, fat mass, hyperinsulinemia, and IR in children with DMD.
METHODS


This placebo-controlled, double-blind, randomized study was carried out in 28 patients with DMD supplemented with 2.9 g/d of Ω-3LCPUFA (n = 14) or sunflower oil (placebo, n = 14) during 6 months. Serum glucose and insulin were measured at baseline and thereafter at months 3 and 6 of the intervention to estimate IR by HOmeostasis Model Assessment. Body composition was assessed by Dual Energy X-ray Absorptiometry.
RESULTS


The percentage of change in EicosaPentaenoic Acid (EPA) and DocosaHexaenoic Acid (DHA) in erythrocytes was significantly (p < 0.05) higher in boys who consumed Ω-3LCPUFA than in the placebo group. Lean mass and fat mass (both in g/kg of Body Weight [BW]) had a trend toward being higher (p = 0.07 at month 3 and p = 0.085 at month 6) and lower (p = 0.05 at month 3 and p = 0.085 at month 6) respectively, in boys with DMD supplemented with Ω-3LCPUFA compared with the placebo group. The loss of lean mass was delayed in the Ω-3LCPUFA group; it started at month 6 but, in placebo, it started at month 3 of supplementation in comparison with the baseline of each group. Fasting insulin, percentage of boys with hyperinsulinemia, and IR were similar between the placebo and Ω-3LCPUFA groups during the 6 months of supplementation. The percentage of boys with IR was significantly (p = 0.045) lower at month 6 of supplementation in the Ω-3LCPUFA group than in the placebo group.
CONCLUSION


This study suggests that Ω-3LCPUFA (2.9 g/day) intake during 6 months likely slows the progression of muscle loss, decreases the fat mass, and reduces IR in boys with DMD. The findings of this study provide scientific background for conducting a randomized trial focused of confirming the possible beneficial role of Ω-3LCPUFA on the previously mentioned alterations mentioned in boys with early muscle damage (without fibrosis) DMD. This research was registered at clinicaltrials.gov (NCT018264229).",2019,"The percentage of boys with IR was significantly (p = 0.045) lower at month 6 of supplementation in the Ω-3LCPUFA group than in the placebo group.
","['28 patients with DMD supplemented with 2.9\xa0g/d of Ω-3LCPUFA (n\xa0=\xa014) or', 'boys with early muscle damage (without fibrosis) DMD', 'patients with DMD develop obesity, hyperinsulinemia, and Insulin Resistance (IR', 'children with DMD']","['placebo', 'sunflower oil (placebo', 'Ω-3LCPUFA consumption', 'omega-3 fatty acids', 'Ω-3LCPUFA', 'Omega-3 Long-Chain PolyUnsaturated Fatty Acids (Ω-3LCPUFA']","['Body composition', 'lean mass, fat mass, hyperinsulinemia, and IR', 'Serum glucose and insulin', 'hyperinsulinemia and insulin resistance', 'percentage of change in EicosaPentaenoic Acid (EPA) and DocosaHexaenoic Acid (DHA) in erythrocytes', 'loss of lean mass', 'percentage of boys with IR', 'Lean mass and fat mass', 'Fasting insulin, percentage of boys with hyperinsulinemia, and IR', 'hyperinsulinemia and IR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinemia'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",28.0,0.241352,"The percentage of boys with IR was significantly (p = 0.045) lower at month 6 of supplementation in the Ω-3LCPUFA group than in the placebo group.
","[{'ForeName': 'Maricela', 'Initials': 'M', 'LastName': 'Rodríguez-Cruz', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico. Electronic address: maricela.rodriguez.cruz@gmail.com.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Atilano-Miguel', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Barbosa-Cortés', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Bernabé-García', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Almeida-Becerril', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cárdenas-Conejo', 'Affiliation': 'Departamento de Genética, Hospital de Pediatría, CMN, SXXI, IMSS, Mexico City, Mexico.'}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Del Rocío Cruz-Guzmán', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maldonado-Hernández', 'Affiliation': 'Laboratorio de Nutrición Molecular, Unidad de Investigación Médica en Nutrición (UIMN), Hospital de Pediatría, Centro Médico Nacional Siglo XXI (CMN-SXXI), Instituto Mexicano del Seguro Social (IMSS), Mexico City, Mexico.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.10.017']
198,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


To determine the effects of advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES) of the quadriceps and gastrocnemius muscles on the ability of wheelchair-dependent people with spinal cord injury (SCI) to transfer and attain independence in activities of daily living (ADLs).
SETTING


An outpatient clinic, Iran.
METHODS


People with traumatic chronic paraplegia (N = 16) were randomly allocated to three groups. The exercise group (EX; N = 5) performed AWMEs of quadruped unilateral reaching and tall-kneeling for 24 weeks (3 days/week). Sessions were increased from 10 min to 54 min over the 24-week period. The exercise-FES group (EX + FES; N = 5) performed AWMEs simultaneously with FES of the quadriceps and gastrocnemius muscles. The control group performed no exercise and no FES (N = 6). The primary outcomes were the total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer. There were six other outcomes.
RESULTS


The mean (95% CI) between-group differences of the four transfer items of the SCIM-III for the EX vs. control group was 1.8 points (0.2-3.4), and for the EX + FES vs. control group was 2 points (0.4-3.6). The equivalent differences for the total SCIM-III scores were 2.7 points (-0.6-6.0) and 4.1 points (0.8-7.4), respectively. There were no significant between-group differences for any other outcomes.
CONCLUSIONS


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.",2020,"CONCLUSIONS


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","['People with traumatic chronic paraplegia (N\u2009=\u200916', 'wheelchair-dependent people with spinal cord injury (SCI', 'An outpatient clinic, Iran']","['no exercise and no FES', 'advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES', 'Advanced weight-bearing mat exercises combined with functional electrical stimulation', 'exercise group (EX; N\u2009=\u20095) performed AWMEs of quadruped unilateral reaching and tall-kneeling']","['total SCIM-III scores', 'total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C3698571', 'cui_str': 'Chronic paraplegia'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456677', 'cui_str': 'Total spinal blockade (finding)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0665244,"CONCLUSIONS


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7']
199,31538405,"Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbar Radicular Pain: A Randomized, Triple-Blind, Active-Control Trial.","BACKGROUND


Lumbar radicular pain (LRP) results from inflammation and irritation of lumbar spinal nerves and the dorsal root ganglion (DRG).
METHODS


Our study is a prospective, triple-blind, randomized, activecontrol trial (CTRI/2016/02/006666) comparing transforaminal epidural local anesthetic (LA) injection and pulsed radiofrequency treatment of DRG in patients with chronic LRP. Patients with LRP after failed conservative management for >3 months received selective diagnostic nerve root block with 1 mL 2% lidocaine. Fifty patients showing positive responses were divided into groups of 25 each. The LA group received transforaminal epidural injection of 1 mL 0.5% bupivacaine. The lumbar pulsed radiofrequency (LPRF) group received transforaminal epidural injection of 1 mL 0.5% bupivacaine with 3 cycles of pulsed radiofrequency of the DRG for 180 seconds RESULTS: Both groups were compared by observing pain intensity on a 0- to 100-point VAS and improvement in functional status by the Oswestry Disability Index (ODI version 2.0) at 2 weeks and 1, 2, 3, and 6 months. All baseline variables were comparable between the 2 groups. Statistically significant reduction in both outcomes was seen in the LPRF group compared to the LA group from 2 weeks to 6 months. One hundred percent of patients in the LPRF group had a ≥20- point decrease in VAS and significant percentage reduction in ODI at all time intervals up to 6 months, whereas it was seen in 80% and 28% of patients in the LA group at 3 and 6 months, respectively. No complications were seen in any patients CONCLUSION: Pulsed radiofrequency of the DRG applied for longer duration results in long-term pain relief and improvement in the functional quality of life in patients with chronic LRP.",2020,Prevalence of low back pain causes an economic burden on society not only by utilizing the health resources but also due to reduced productivity due to absenteeism from the workplace.,['Lumbosacral Radicular Pain'],['Transforaminal Epidural Injection of Local Anaesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment'],"['inflammation and irritation of lumbar spinal nerves and dorsal root ganglion (DRG', 'Lumbar radicular pain (LRP', 'Low back pain (LBP', 'low back pain']","[{'cui': 'C0450206', 'cui_str': 'Lumbosacral (qualifier value)'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}]","[{'cui': 'C0021486', 'cui_str': 'Extradural Injections'}, {'cui': 'C0002934', 'cui_str': 'Conduction-Blocking Anesthetics'}, {'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}, {'cui': 'C3179076', 'cui_str': 'Pulsed Radio Frequency Treatment'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441723', 'cui_str': 'Irritation (qualifier value)'}, {'cui': 'C0228897', 'cui_str': 'Lumbar nerve'}, {'cui': 'C0017070', 'cui_str': 'Dorsal Root Ganglia'}, {'cui': 'C0011928', 'cui_str': 'DRG'}, {'cui': 'C4552557', 'cui_str': 'Lumbar radicular pain'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]",,0.0378051,Prevalence of low back pain causes an economic burden on society not only by utilizing the health resources but also due to reduced productivity due to absenteeism from the workplace.,"[{'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'De', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Virender K', 'Initials': 'VK', 'LastName': 'Mohan', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Debesh', 'Initials': 'D', 'LastName': 'Bhoi', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Talawar', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Sciences, Rishikesh, India.'}, {'ForeName': 'Ajeet', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, All India Institute of Medical Sciences, Patna, India.'}, {'ForeName': 'Bhavuk', 'Initials': 'B', 'LastName': 'Garg', 'Affiliation': 'Department of Orthopaedics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anjan', 'Initials': 'A', 'LastName': 'Trikha', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Dehran', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Lokesh', 'Initials': 'L', 'LastName': 'Kashyap', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dilip R', 'Initials': 'DR', 'LastName': 'Shende', 'Affiliation': 'Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, India.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12840']
200,32198079,Improved monitoring of adherence with patching treatment using a microsensor and Eye Patch Assistant.,"BACKGROUND


Use of a microsensor has been suggested to monitor patching adherence. Application has been limited because the microsensor's small size makes it easy to lose and a swallowing risk. We designed the Eye Patch Assistant (EPA) to hold the small microsensor in place and reduce the risk of loss or swallowing. This study reports the accuracy, precision, ease of use, and comfort for patching with EPA (patch+EPA) to monitor adherence.
METHODS


Adults (N = 13) wore an adhesive patch alone or a patch+EPA for 2 hours each, recorded wear time, and completed an ease of use/comfort questionnaire; 30 children wore a patch or patch+EPA and completed the questionnaire. Sensor sampling interval was every 5 minutes or every 1 minute. Sensor accuracy and precision were evaluated by Bland-Altman analysis and 95% limits of agreement, and questionnaire scores compared by Wilcoxon tests.
RESULTS


With 5-minute sampling, we found excellent accuracy for adults (mean actual vs recorded time difference, 1.4 minutes) and children (mean difference, -0.9 min). We found high precision for both adults and children (95% limits of agreement half widths of 6.4 minutes and 1.9 minutes, respectively). In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01). For children, scores did not differ significantly. The patch+EPA functioned well between 45° and 82°F.
CONCLUSIONS


The patch+EPA was well accepted and monitored adherence accurately and precisely.",2020,"In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01).",['Adults (N = 13) wore an'],"['Eye Patch Assistant (EPA', 'adhesive patch alone or a patch+EPA for 2 hours each, recorded wear time, and completed an ease of use/comfort questionnaire; 30 children wore a patch or patch+EPA']","['comfort score', 'risk of loss or swallowing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}]",,0.0380849,"In adults, the ease of use score for the patch+EPA was lower than the patch (P < 0.01), but the comfort score for the patch+EPA was higher (P < 0.01).","[{'ForeName': 'Jingyun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Salus University Pennsylvania College of Optometry, Elkins Park, Pennsylvania. Electronic address: jingyun.wang@gmail.com.'}, {'ForeName': 'Hongxin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Panorama Windows Ltd. New York, New York.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'De La Cruz', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Morale', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'Reed M', 'Initials': 'RM', 'LastName': 'Jost', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leske', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Birch', 'Affiliation': 'Retina Foundation of the Southwest, Dallas, Texas.'}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2020.01.006']
201,31916660,"Understanding the impact of complicated grief on combat related posttraumatic stress disorder, guilt, suicide, and functional impairment in a clinical trial of post-9/11 service members and veterans.","BACKGROUND


Complicated grief (CG) is a bereavement-specific syndrome distinct from but commonly comorbid with posttraumatic stress disorder (PTSD). While bereavement is common among military personnel (Simon et al., 2018), there is little research on the impact of CG comorbidity on PTSD treatment outcomes.
METHODS


To evaluate the impact of comorbid CG on PTSD treatment outcomes we analyzed data from a randomized trial comparing prolonged exposure, sertraline, and their combination in veterans with a primary diagnosis of combat-related PTSD (n = 194). Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior occurred at baseline and weeks 6, 12, and 24 during the 24-week trial.
RESULTS


CG was associated with lower PTSD treatment response (odds ratio (OR) = 0.29, 95% confidence interval (CI) [0.12, 0.69], p = 0.005) and remission (OR = 0.28, 95% CI [0.11, 0.71], p = 0.007). Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint. In addition, those with CG were more likely to experience suicidal ideation during the study (CG: 35%, 14/40 vs. no CG 15%, 20/130; OR = 3.01, 95% CI [1.29, 7.02], p = 0.011).
CONCLUSIONS


Comorbid CG is associated with elevated PTSD severity and independently associated with poorer endpoint treatment outcomes in veterans with combat-related PTSD, suggesting that screening and additional intervention for CG may be needed.",2020,Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint.,"['post-9/11 service members and veterans', 'veterans with a primary diagnosis of combat-related PTSD (n\u2009=\u2009194']",['sertraline'],"['remission', 'trauma-related guilt', 'severity of PTSD', 'Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior', 'PTSD treatment response', 'experience suicidal ideation']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0594661,Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint.,"[{'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Lubin', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Robinaugh', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Malgaroli', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'National Center for PTSD, White River Junction, Vermont.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Mental Health Service Line, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Goetter', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Samantha N', 'Initials': 'SN', 'LastName': 'Hellberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Charney', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amanda W', 'Initials': 'AW', 'LastName': 'Baker', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}]",Depression and anxiety,['10.1002/da.22911']
202,32269278,The effect of a mindfulness-based therapy on different biomarkers among patients with inflammatory bowel disease: a randomised controlled trial.,"Mindfulness-based interventions have shown some efficacy in decreasing stress levels and improving quality of life. However, so far, only a few studies have studied this type of intervention among patients with inflammatory bowel disease and none of them have studied their effects on inflammatory biomarkers. This current study was a two-armed, single-centre, randomised (2:1 ratio) controlled trial used to evaluate the effects of a mindfulness-based intervention (n = 37) compared to standard medical therapy (n = 20) in patients with Crohn's disease or ulcerative colitis. The mindfulness intervention blended four internet-based therapy modules with four face-to-face support sessions. The outcomes we assessed were faecal calprotectin (primary outcome), C-reactive protein, and cortisol levels measured in hair samples at several timepoints. The between-group analysis highlighted significant decreases in faecal calprotectin and in C-reactive protein levels in the mindfulness-based intervention group compared to the standard medical therapy group at the six-month follow-up (faecal calprotectin: -367, [95% CI: -705, -29], P = 0.03; C-reactive protein: -2.82, [95% CI: -5.70, 0.08], P = 0.05), with moderate to large effect sizes (faecal calprotectin: ηp 2  = 0.085; C-reactive protein: ηp 2  = 0.066). We concluded that mindfulness-based therapy administered as part of standard clinical practice effectively improves inflammatory biomarkers in patients diagnosed with inflammatory bowel disease.",2020,The between-group analysis highlighted significant decreases in faecal calprotectin and in C-reactive protein levels in the mindfulness-based intervention group compared to the standard medical therapy group at the six-month follow-up (faecal calprotectin,"['patients diagnosed with inflammatory bowel disease', ""patients with Crohn's disease or ulcerative colitis"", 'patients with inflammatory bowel disease']","['mindfulness-based intervention (n\u2009=\u200937) compared to standard medical therapy', 'mindfulness-based therapy', 'mindfulness intervention blended four internet-based therapy modules with four face-to-face support sessions']","['moderate to large effect sizes (faecal calprotectin', 'inflammatory biomarkers', 'quality of life', 'faecal calprotectin (primary outcome), C-reactive protein, and cortisol levels measured in hair samples at several timepoints', 'faecal calprotectin and in C-reactive protein levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444095', 'cui_str': 'Hair specimen'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}]",,0.0968732,The between-group analysis highlighted significant decreases in faecal calprotectin and in C-reactive protein levels in the mindfulness-based intervention group compared to the standard medical therapy group at the six-month follow-up (faecal calprotectin,"[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'González-Moret', 'Affiliation': 'Department of Nursing, Universidad Cardenal Herrera-CEU, CEU Universities, Castellon, Spain.'}, {'ForeName': 'Ausias', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation, and psychological treatments, Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Cortés', 'Affiliation': 'Internal Medicine Service, Digestive Medicine Section, Hospital Universitario de Sagunto, Valencia, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'Department of Personality, Evaluation, and psychological treatments, Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Navarrete', 'Affiliation': 'Department of Personality, Evaluation, and psychological treatments, Universidad de Valencia, Valencia, Spain.'}, {'ForeName': 'José Enrique', 'Initials': 'JE', 'LastName': 'de la Rubia', 'Affiliation': 'Department of Nursing, Catholic University San Vicente Martir, Valencia, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Lisón', 'Affiliation': 'Institute of Biomedical Sciences, Universidad Cardenal Herrera-CEU Universities, Valencia, Spain.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'Soria', 'Affiliation': 'Department of Biomedical Sciences, Universidad Cardenal Herrera-CEU Universities, Valencia, Spain. jose.soria@uchceu.es.'}]",Scientific reports,['10.1038/s41598-020-63168-4']
203,32273563,A Randomised Control Trial and Comparative Analysis of Multi-Dimensional Learning Tools in Anatomy.,"This article presents the results of a study that examined students' ability to retain what they have learned in an anatomy course after thirty days via using various learning tools for twenty minutes. Fifty-two second-year medical students were randomly assigned to three learning tools: text-only, three-dimension visualisation in a two-dimensional screen (3DM), or mixed reality (MR). An anatomy test lasting for twenty minutes measuring spatial and nominal knowledge was taken immediately after the learning intervention and another thirty days later. Psychometric tests were also used to measure participants' memory, reasoning and concentration abilities. Additionally, electroencephalogram data was captured to measure the participants' awakeness during the learning session. Results of this study showed that the MR group performed poorly in the nominal questions compared to the other groups; however, the MR group demonstrated higher retention in both the nominal and spatial type information for at least a month compared to the other groups. Furthermore, participants in the 3DM and MR groups reported increased engagement. The results of this study suggest that three-dimensional visualiser tools are likely to enhance learning in anatomy education. However, the study itself has several limitations; some include limited sample size and various threats to internal validity.",2020,"Results of this study showed that the MR group performed poorly in the nominal questions compared to the other groups; however, the MR group demonstrated higher retention in both the nominal and spatial type information for at least a month compared to the other groups.",['Fifty-two second-year medical students'],"['learning tools: text-only, three-dimension visualisation in a two-dimensional screen (3DM), or mixed reality (MR']","[""participants' memory, reasoning and concentration abilities""]","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0424098', 'cui_str': 'Ability to concentrate'}]",,0.0188912,"Results of this study showed that the MR group performed poorly in the nominal questions compared to the other groups; however, the MR group demonstrated higher retention in both the nominal and spatial type information for at least a month compared to the other groups.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Ben Kei', 'Initials': 'BK', 'LastName': 'Daniel', 'Affiliation': 'Education Technology Group, Higher Education Development Centre, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Asil', 'Affiliation': 'Centre for Healthcare Education and Research Innovation (CHERI), School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Prashanna', 'Initials': 'P', 'LastName': 'Khwaounjoo', 'Affiliation': 'Department of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Yusuf Ozgur', 'Initials': 'YO', 'LastName': 'Cakmak', 'Affiliation': 'Department of Anatomy, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand. yusuf.cakmak@otago.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-62855-6']
204,32277134,Efficacy of Ultrasound-guided Radiofrequency Ablation of Parathyroid Hyperplasia: Single Session vs. Two-Session for Effect on Hypocalcemia.,"To evaluate safety and efficacy of one- vs. two-session radiofrequency ablation (RFA) of parathyroid hyperplasia for patients with secondary hyperparathyroidism (SHPT) and to compare the outcome of both methods on hypocalcemia. Patients with secondary hyperparathyroidism underwent ultrasound guided RFA of parathyroid hyperplasia. Patients were alternately assigned to either group 1 (n = 28) with RFA of all 4 glands in one session or group 2 (n = 28) with RFA of 2 glands in a first session and other 2 glands in a second session. Serum parathyroid hormone (PTH), calcium, phosphorus and alkaline phosphatase (ALP) values were measured at a series of time points after RFA. RFA parameters, including operation duration and ablation time and hospitalization length and cost, were compared between the two groups. Mean PTH decreased in group 1 from 1865.18 ± 828.93 pg/ml to 145.72 ± 119.27 pg/ml at 1 day after RFA and in group 2 from 2256.64 ± 1021.72 pg/ml to 1388.13 ± 890.15 pg/ml at 1 day after first RFA and to 137.26 ± 107.12 pg/ml at 1 day after second RFA. Group 1's calcium level decreased to 1.79 ± 0.31 mmol/L at day 1 after RFA and group 2 decreased to 1.89 ± 0.26 mmol/L at day 1 after second session RFA (P < 0.05). Multivariate analysis showed that hypocalcemia was related to serum ALP. Patients with ALP ≥ 566 U/L had lower calcium compared to patients with ALP < 566 U/L up to a month after RFA (P < 0.05). Group 1's RFA time and hospitalization were shorter and had lower cost compared with Group 2. US-guided RFA of parathyroid hyperplasia is a safe and effective method for treating secondary hyperparathyroidism. Single-session RFA was more cost-effective and resulted in a shorter hospital stay compared to two sessions. However, patients with two-session RFA had less hypocalcemia, especially those with high ALP.",2020,Mean PTH decreased in group 1 from 1865.18 ± 828.93 pg/ml to 145.72 ± 119.27 pg/ml at 1 day after RFA and in group 2 from 2256.64 ± 1021.72 pg/ml to 1388.13 ± 890.15 pg/ml at 1 day after first RFA and to 137.26 ± 107.12 pg/ml at 1 day after second RFA.,"['Patients with ALP\u2009≥', 'patients with secondary hyperparathyroidism (SHPT', 'Patients with secondary hyperparathyroidism underwent ultrasound guided RFA of parathyroid hyperplasia']","['one- vs. two-session radiofrequency ablation (RFA', 'RFA of all 4 glands in one session or group 2 (n\u2009=\u200928) with RFA of 2 glands in a first session and other 2 glands in a second session', 'parathyroid hyperplasia', 'Ultrasound-guided Radiofrequency Ablation']","['Serum parathyroid hormone (PTH), calcium, phosphorus and alkaline phosphatase (ALP) values', 'calcium level', 'shorter hospital stay', 'safety and efficacy', 'hypocalcemia', 'RFA time and hospitalization', 'RFA parameters, including operation duration and ablation time and hospitalization length and cost', 'Hypocalcemia', 'Mean PTH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0271844', 'cui_str': 'Parathyroid hyperplasia'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C1285092', 'cui_str': 'Gland structure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0271844', 'cui_str': 'Parathyroid hyperplasia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}]",,0.0252517,Mean PTH decreased in group 1 from 1865.18 ± 828.93 pg/ml to 145.72 ± 119.27 pg/ml at 1 day after RFA and in group 2 from 2256.64 ± 1021.72 pg/ml to 1388.13 ± 890.15 pg/ml at 1 day after first RFA and to 137.26 ± 107.12 pg/ml at 1 day after second RFA.,"[{'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Cheng-Zhong', 'Initials': 'CZ', 'LastName': 'Peng', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China. pcz001@126.com.""}, {'ForeName': 'Ji-Bin', 'Initials': 'JB', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, USA.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Hong-Feng', 'Initials': 'HF', 'LastName': 'He', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Qiao-Hong', 'Initials': 'QH', 'LastName': 'Hu', 'Affiliation': ""Department of Ultrasound, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}, {'ForeName': 'Xiao-Gang', 'Initials': 'XG', 'LastName': 'Shen', 'Affiliation': ""Department of Nephrology, Zhejiang Provincial People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China.""}]",Scientific reports,['10.1038/s41598-020-63299-8']
205,31282129,Renal insufficiency following contrast media administration trial III: Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration in high-risk patients for contrast-induced acute kidney injury. Rationale and design.,"BACKGROUND


Urine flow rate (UFR)-guided and left-ventricular end-diastolic pressure (LVEDP)-guided hydration regimens have been proposed to prevent contrast-induced acute kidney injury (CIAKI). The REnal Insufficiency Following Contrast MEDIA Administration triaL III (REMEDIAL III) is a randomized, multicenter, investigator-sponsored trial aiming to compare these two hydration strategies.
METHODS


Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate ≤ 45 mL/min/1.73 m 2  and/or with Mehran's score ≥11 and/or Gurm's score >7) will be enrolled. Patients will be randomly assigned to (a) LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group). Seven-hundred patients (350 in each arm) will be enrolled. In the LVEDP-guided group the fluid infusion rate will be adjusted according to the LVEDP as follows: 5 mL kg -1  hr -1  for LVEDP ≤12 mmHg, 3 mL kg -1  hr -1  for LVEDP 13-18 mmHg, and 1.5 mL kg -1  hr -1  for LVEDP >18 mmHg. In the RenalGuard group hydration with normal saline plus low-dose of furosemide is controlled by the RenalGuard system, in order to reach and maintain a high (>300 mL/hr) UFR. In all cases, iobitridol (a low-osmolar, nonionic contrast agent) will be administered.
RESULTS


The primary endpoint is the composite of CIAKI (i.e., serum creatinine increase ≥25% and/or ≥0.5 mg/dL from the baseline to 48 hr after contrast media exposure) and/or acute pulmonary edema.
CONCLUSION


The REMEDIAL III will test the hypothesis that the UFR-guided hydration is superior to the LVEDP-guided hydration to prevent the composite of CIAKI and/or acute pulmonary edema.",2020,-1  hr -1  for LVEDP,"['Seven-hundred patients (350 in each arm) will be enrolled', 'high-risk patients for contrast-induced acute kidney injury', ""Patients at high risk for CIAKI (that is, those with estimated glomerular filtration rate\u2009≤\u200945\u2009mL/min/1.73\u2009m 2  and/or with Mehran's score""]","['Urine flow rate-guided versus left-ventricular end-diastolic pressure-guided hydration', 'normal saline plus low-dose of furosemide', 'LVEDP-guided hydration with normal saline (LVEDP-guided group) and (b) UFR-guided hydration carried out by the RenalGuard system (RenalGuard group', 'iobitridol', 'LVEDP']","['composite of CIAKI (i.e., serum creatinine increase ≥25', 'fluid infusion rate']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C3811844'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0042037'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1171395', 'cui_str': 'Left ventricular end-diastolic pressure'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0296806', 'cui_str': 'iobitridol'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0700225', 'cui_str': 'Serum creatinine raised (finding)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]",700.0,0.0915012,-1  hr -1  for LVEDP,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': ""D'Amore"", 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Micco', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Signore', 'Affiliation': 'Interventional Cardiology Unit, Policlinico di Bari, Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Science, Division of Cardiology, ""Federico II"" University of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Napolitano', 'Affiliation': 'Department of Cardiology, Ospedale San Giuliano, Giuliano, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Focaccio', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28386']
206,31505082,The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain?,"The objective of the present analysis was to determine whether changes in Brief Pain Inventory (BPI) average pain scores by patient global impression of improvement (PGI-I) category and the cut-off for clinically important difference (CID) were different between Asian and Caucasian patients with chronic pain due to osteoarthritis. This analysis used data from 3 (Caucasian) and 2 (Asian) randomized, placebo-controlled, 10- to 14-week duloxetine studies for the treatment of patients ≥40 years of age with osteoarthritis pain. The receiver operating characteristic (ROC) analysis was used to characterize the association between changes in BPI average pain scores and PGI-I levels at study endpoint. The CID was characterized by PGI-I, and the cut-off point for CID in BPI average pain scores was determined by the intersection of a 45-degree tangent line with each ROC curve. Data from 668 Asian and 868 Caucasian patients were available for analysis. Baseline BPI average pain ratings including worst and least pain were comparable between Asians and Caucasians. Ratings for percentage change from baseline to endpoint for BPI average pain scores in Asian patients and Caucasian patients were similar across the 7 PGI-I categories, regardless of age, gender, study, and treatment. The ROC analysis results of cut-off points in BPI average pain scores demonstrated the raw change cut-off was -3.0, and percentage change cut-off was -40% for both Asian and Caucasian patients. Overall, the present analysis concludes changes in BPI average pain scores by PGI-I category and the cut-off for CID were similar for Asian and Caucasian patients with chronic pain due to osteoarthritis.",2020,"Ratings for percentage change from baseline to endpoint for BPI average pain in Asian patients and Caucasian patients were similar across the 7 PGI-I categories, regardless of age, gender, study, and treatment.","['Asian patients and Caucasian patients', '668 Asian and 868 Caucasian patients', 'Asian and Caucasian patients with chronic pain due to osteoarthritis', 'patients aged ≥40 years with osteoarthritis pain', 'Asian and Caucasian Patients with Osteoarthritis Pain']","['placebo', 'duloxetine']","['Brief Pain Inventory (BPI) average pain by patient global impression of improvement (PGI-I) category and the cut-off for clinically important difference (CID', 'BPI average pain', 'Pain Severity Changes', 'Baseline BPI average pain ratings including worst and least pain']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",668.0,0.0859539,"Ratings for percentage change from baseline to endpoint for BPI average pain in Asian patients and Caucasian patients were similar across the 7 PGI-I categories, regardless of age, gender, study, and treatment.","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yue', 'Affiliation': 'Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, Shanghai, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, Shanghai, China.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Enomoto', 'Affiliation': 'Medicine Development Unit-Japan, Eli Lilly Japan K.K., Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Fujikoshi', 'Affiliation': 'Medicine Development Unit-Japan, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Alev', 'Affiliation': 'TR Medical Mgmt, Eli Lilly Turkey, Istanbul, Turkey.'}, {'ForeName': 'Yan Yolanda', 'Initials': 'YY', 'LastName': 'Cheng', 'Affiliation': 'Medical Department, Lilly Suzhou Pharmaceutical Co. Ltd. Shanghai Branch, Shanghai, China.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana, U.S.A.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12835']
207,32297837,Reducing Cardiovascular Disease Risk in Women Beyond Statin Therapy: New Insights 2020.,"Management of residual and persistent cardiovascular disease (CVD) risk among statin-treated individuals has emerged as an important preventive strategy. The purpose of this article is to review the unique landscape of CVD in women and relevant prior prevention trials, and to discuss how the recent results of the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) might apply to the contemporary management of CVD risk among statin-treated women. Women have unique risk factors that may impact CVD and its prevention. Historically, women have been underrepresented in CVD trials, posing a challenge to development of clinical recommendations for women. Low-density lipoprotein cholesterol-targeting treatments have demonstrated CVD risk reduction, with comparable effects in both sexes. In contrast, triglyceride-lowering treatments (niacin, fenofibrate, and omega-3 fatty acids) have reported mixed findings for CVD risk reduction. Recent clinical trials of combination omega-3 fatty acids (docosahexaenoic acid/eicosapentaenoic acid [EPA]) have not found significant CVD risk reduction. The recently published REDUCE-IT study found that icosapent ethyl, an EPA-only omega-3 fatty acid, in combination with statins, significantly reduced CVD events in high-risk patients. The icosapent ethyl group had a significantly lower occurrence of the primary composite CVD endpoint (17.2%) than the placebo group (22.0%; hazard ratio 0.75; 95% confidence interval 0.68-0.83;  p  < 0.001). CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33). Data from REDUCE-IT suggest women benefit similarly to men with respect to icosapent ethyl, a novel therapy for prevention of CVD.",2020,"CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33).",['high-risk patients'],"['triglyceride-lowering treatments (niacin, fenofibrate, and omega-3 fatty acids', 'placebo', 'combination omega-3 fatty acids (docosahexaenoic acid/eicosapentaenoic acid [EPA']","['CVD risk reduction', 'CVD events', 'primary composite CVD endpoint']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",,0.0558982,"CVD risk reduction with icosapent ethyl treatment was comparable between women and men ( p  for interaction, 0.33).","[{'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Mosca', 'Affiliation': 'Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Nanette Kass', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': ""Department of Cardiology, Emory University School of Medicine; Emory Heart and Vascular Center; Emory Women's Heart Center, Atlanta, Georgia, USA.""}]",Journal of women's health (2002),['10.1089/jwh.2019.8189']
208,31530653,Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial.,"BACKGROUND


The pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established.
METHODS


A single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process.
RESULTS


From February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53-70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12-20)/3(1-12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39-59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be 'clear' and 83% felt 'very comfortable' in signing. The overall experience was 'excellent/good' in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.
CONCLUSIONS


e-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.",2020,"Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.
","['From February to November 2018, 60 consecutive patients were e-Consented']",['smartphone platform'],['baseline/discharge National Institutes of Health Stroke Scale score'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.114825,"Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent.
","[{'ForeName': 'Diogo C', 'Initials': 'DC', 'LastName': 'Haussen', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Craft', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Doppelheuer', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Gabriel Martins', 'Initials': 'GM', 'LastName': 'Rodrigues', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Alhamza R', 'Initials': 'AR', 'LastName': 'Al-Bayati', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ravindran', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Schultz', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Sutherly', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Kiva M', 'Initials': 'KM', 'LastName': 'Schindler', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Frankel', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Neurology, Emory University School of Medicine/Marcus Stroke & Neuroscience Center -Grady Memorial Hospital, Atlanta, Florida, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015283']
209,32294325,Does the method of administering fluids matter for contrast-induced nephropathy? REMEDIAL III compares LVEDP versus urine flow-guided hydration.,"Contrast-induced nephropathy (CIN) is a major cause of morbidity and mortality among patients undergoing angiographic procedures. Limiting contrast dose and administration of intravenous normal saline appear to be the best approaches to reducing CIN, but the timing, dose, and duration of optimal hydration is poorly understood. The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.",2020,"The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.","['700 patients at high risk of CIN', 'patients undergoing angiographic procedures']","['LVEDP versus urine flow-guided hydration', 'intravenous normal saline', 'hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP']",[],"[{'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0206708', 'cui_str': 'Cervical intraepithelial neoplasia'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0456190', 'cui_str': 'Left ventricular end-diastolic pressure'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C2919339', 'cui_str': 'Measurement of urine output'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",[],,0.0288212,"The REMEDIAL III trial protocol outlines two different targeted hydration regimens (guided either by continuous measurement of urine output or by initial left ventricular end diastolic pressure (LVEDP), and 700 patients at high risk of CIN will be randomized.","[{'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Grines', 'Affiliation': 'Northside Cardiovascular Institute, Atlanta, Georgia, USA.'}, {'ForeName': 'J Jeffrey', 'Initials': 'JJ', 'LastName': 'Marshall', 'Affiliation': 'Northside Cardiovascular Institute, Atlanta, Georgia, USA.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28879']
210,31712614,Study protocol of a double-blind randomised placebo-controlled trial on the effect of a multispecies probiotic on the incidence of antibiotic-associated diarrhoea in persons with spinal cord injury.,"STUDY DESIGN


Multi-centre, double-blind randomised placebo-controlled study.
OBJECTIVE


To investigate whether the use of a multispecies probiotic can prevent antibiotic-associated diarrhoea in people with spinal cord injury (SCI).
SETTING


Three Dutch SCI rehabilitation centres.
METHODS


Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0). After cessation of the antibiotics (T1), the participants will use probiotics/placebo for 3 more weeks (T2). Defaecation, assessed by the Bristol Stool Scale, and bowel management will be monitored daily until 2 weeks after cessation of probiotics/placebo intake (T3). Also, the degree of nausea and information on quality of life will be collected at T0, T1, T2 and T3.
MAIN OUTCOME MEASURES


The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
SECONDARY OUTCOME MEASURES


The time to reach effective bowel management, degree of nausea and quality of life.
REGISTRATION


The Dutch Trial Register- NTR 5831.",2020,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","['persons with spinal cord injury', 'Fifty-six people aged 18-75 years with SCI during inpatient rehabilitation, who require antibiotics, will be given probiotics or placebo randomly assigned (T0', 'Three Dutch SCI rehabilitation centres', 'people with\xa0spinal cord injury (SCI']","['placebo', 'multispecies probiotic', 'probiotics/placebo']","['degree of nausea and information on quality of life', 'incidence of antibiotic-associated diarrhoea', 'Bristol Stool Scale, and bowel management', 'time to reach effective bowel management, degree of nausea and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0578159', 'cui_str': 'Antibiotic-associated diarrhea (disorder)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0222045'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",56.0,0.712196,"The difference between the incidence of antibiotic-associated diarrhoea between people with SCI using probiotics compared to those using a placebo at the moment the antibiotics stops, the probiotics stops and two weeks thereafter.
","[{'ForeName': 'W X M', 'Initials': 'WXM', 'LastName': 'Faber', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands. w.faber@heliomare.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Nachtegaal', 'Affiliation': 'Department of Research & Development, Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Stolwijk-Swuste', 'Affiliation': 'Center of Excellence for Rehabilitation Medicine, Brain Center Rudolf Magnus, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Achterberg-Warmer', 'Affiliation': 'Amsterdam Rehabilitation Research Center, Reade, the Netherlands.'}, {'ForeName': 'C J M', 'Initials': 'CJM', 'LastName': 'Koning', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Besseling-van der Vaart', 'Affiliation': 'Winclove Probiotics B.V, Amsterdam, The Netherlands.'}, {'ForeName': 'C A M', 'Initials': 'CAM', 'LastName': 'van Bennekom', 'Affiliation': 'Heliomare Rehabilitation Center, Wijk aan Zee, The Netherlands.'}]",Spinal cord,['10.1038/s41393-019-0369-y']
211,30608521,"Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial.","AIMS


The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensive patients. The current report describes the effects of RDN on heart rate (HR) in this population.
METHODS AND RESULTS


Patients were enrolled with an office systolic BP (SBP) of ≥150 mmHg and <180 mmHg, office diastolic BP (DBP) of ≥90 mmHg, and a mean ambulatory SBP of ≥140 mmHg and <170 mmHg. Patients were drug naïve or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3 months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3 months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P = 0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7 mmHg difference, P = 0.001) and DBP (-7.5 mmHg, P < 0.001), whereas BP changes in RDN patients with below-median HRs were not significant.
CONCLUSION


Average and minimum morning HR were significantly reduced at 3 months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure.",2019,"Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026).","['Eighty patients', 'Patients were drug naïve or removed from their anti-hypertensive medications', 'hypertensive patients not receiving anti-hypertensive medications', 'Patients were enrolled with an office systolic BP (SBP) of ≥150\u2009mmHg and <180\u2009mmHg, office diastolic BP (DBP) of ≥90\u2009mmHg, and a mean ambulatory SBP of ≥140\u2009mmHg and <170\u2009mmHg', 'non-medicated hypertensive patients']","['RDN or sham procedure', 'RDN', 'renal denervation (RDN) using a multi-electrode catheter', 'catheter-based renal denervation']","['average ambulatory SBP', 'DBP', 'Average and minimum morning HR', 'heart rate (HR', 'Ambulatory heart rate reduction', 'BP and HR changes', '24-h HR', 'minimum morning HR', 'ambulatory blood pressure (BP', 'BP reductions', 'BP changes']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1292747', 'cui_str': 'Removes from'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.100608,"Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Department of Interventional Cardiology, Piedmont Heart Institute, 275 Collier Rd NW #500, Atlanta, GA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ukena', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'Department of Medicine, SUNY Downstate College of Medicine, 450 Clarkson Ave, Brooklyn, NY, USA.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Tochigi-ken, Japan.'}, {'ForeName': 'Manesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA.'}, {'ForeName': 'Crystal C', 'Initials': 'CC', 'LastName': 'Tyson', 'Affiliation': 'Department of Internal Medicine, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Weil', 'Affiliation': 'Department of Cardiology, Sana Cardiomed Heart Center, Kronsforder Allee 71, Lübeck, Germany.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Agdirlioglu', 'Affiliation': 'Department of Cardiology, Sana Cardiomed Heart Center, Kronsforder Allee 71, Lübeck, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fahy', 'Affiliation': 'Medtronic PLC, Santa Rosa, CA, USA.'}, {'ForeName': 'Kazuomo', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Tochigi-ken, Japan.'}]",European heart journal,['10.1093/eurheartj/ehy871']
212,31442303,"Randomized trial of weight loss in primary breast cancer: Impact on body composition, circulating biomarkers and tumor characteristics.","Obesity adversely impacts overall and cancer-specific survival among breast cancer patients. Preclinical studies demonstrate negative energy balance inhibits cancer progression; however, feasibility and effects in patients are unknown. A two-arm, single-blinded, randomized controlled weight-loss trial was undertaken presurgery among 32 overweight/obese, Stage 0-II breast cancer patients. The attention control arm (AC) received basic nutritional counseling and upper-body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise to promote 0.68-0.92 kg/week weight loss. Anthropometrics, body composition, blood and survey data were collected at baseline and presurgery ∼30 days later. Tumor markers (e.g., Ki67) and gene expression were assessed on biopsy and surgical specimens; sera were analyzed for cytokines, growth and metabolic factors. Significant WLI vs. AC differences were seen in baseline-to-follow-up changes in weight (-3.62 vs. -0.52 kg), %body fat (-1.3 vs. 0%), moderate-to-vigorous physical activity (+224 vs. +115 min/week), caloric density (-0.3 vs. 0 kcal/g), serum leptin (-12.3 vs. -4.0 ng/dl) and upregulation of tumor PI3Kinase signaling and cell cycle-apoptosis related genes (CC-ARG; all p-values <0.05). Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity. Increased tumor (nuclear) TNFα and IL-1β, CX3CL1 and CXCL1 gene expression was observed in the WLI. Tumor Ki67 did not differ between arms. Feasibility benchmarks included 80% accrual, 100% retention, no adverse effects and excellent adherence. Short-term weight loss interventions are feasible; however, mixed effects on tumor biology suggest unclear benefit to presurgical caloric restriction, but possible benefits of physical activity.",2020,Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity.,"['breast cancer patients', '32 overweight/obese, stage 0-II', 'Primary Breast Cancer']","['basic nutritional counseling and upper-body progressive resistance training whereas the weight loss intervention (WLI) arm received identical guidance, plus counseling on caloric restriction and aerobic exercise']","['Obesity adversely impacts overall and cancer-specific survival', 'weight loss; CC-ARG', 'adverse effects, and excellent adherence', 'moderate-to-vigorous physical activity', 'CX3CL1, and CXCL1 gene expression', 'Tumor Ki67', 'caloric density', 'weight ', 'Increased tumor(nuclear) TNFα and IL-1β', 'Tumor markers (e.g., Ki67) and gene expression', 'Cytolytic CD56 dim  NK cell expression', 'serum leptin', 'body fat', 'Anthropometrics, body composition, blood, and survey data']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1135809', 'cui_str': 'Caloric Restriction'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005768'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0244253,Cytolytic CD56 dim  NK cell expression was positively associated with weight loss; CC-ARG increased with physical activity.,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Gibson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Shuko', 'Initials': 'S', 'LastName': 'Harada', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Frugé', 'Affiliation': 'Auburn University, Auburn, AL.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Grizzle', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Lyse A', 'Initials': 'LA', 'LastName': 'Norian', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB) 1675 University Blvd, Birmingham, AL.'}, {'ForeName': 'Eddy S', 'Initials': 'ES', 'LastName': 'Yang', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Della Manna', 'Affiliation': 'Department of Radiation Oncology, UAB, Birmingham, AL.'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Azrad', 'Affiliation': 'Department of Human Nutrition, Tuscaloosa, AL.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': ""O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL.""}]",International journal of cancer,['10.1002/ijc.32637']
213,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN


Randomized trial.
OBJECTIVES


To evaluate the effectiveness of a 5-week sprint interval training (SIT) protocol on an arm-crank ergometer in individuals with sub-acute spinal cord injury (SCI).
SETTING


Inpatient rehabilitation.
METHODS


Individuals with SCI (N = 20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46 ± 16 years; 15 M/5 F) were randomized to SIT or moderate-intensity continuous training (MICT). SIT consisted of 3 × 20 s. 'all-out' cycle sprints (≥100% peak power output) interspersed with 2 min of active recovery (10% peak power output; total time commitment, 10 mins). MICT involved 20 min of cycling (45% peak power output; total time commitment, 25 mins). Both training interventions were delivered 3 times/week for 5 weeks. Heart rate and Borg's Rating of Perceived Exertion (RPE; 6-20) were monitored throughout training sessions. Maximal and sub-maximal power outputs were assessed on an arm-crank ergometer. Exercise enjoyment, exercise self-efficacy, and pain were assessed at the end of the intervention.
RESULTS


During training sessions, heart rate (135 bpm vs. 119 bpm; p = 0.05), peripheral RPE (16 vs. 12; p = 0.000), and central RPE (15 vs. 11; p = 0.004) responses were higher in the SIT group, yet total work performed was greater in MICT. Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524). Similarly, improvements in sub-maximal power output were not different across groups. There were no between-group differences in exercise enjoyment (p = 0.385), exercise self-efficacy (p = 0.930), or pain (p = 0780).
CONCLUSIONS


Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6']
214,32053137,Effect of Pembrolizumab Plus Neoadjuvant Chemotherapy on Pathologic Complete Response in Women With Early-Stage Breast Cancer: An Analysis of the Ongoing Phase 2 Adaptively Randomized I-SPY2 Trial.,"Importance


Approximately 25% of patients with early-stage breast cancer who receive (neo)adjuvant chemotherapy experience a recurrence within 5 years. Improvements in therapy are greatly needed.
Objective


To determine if pembrolizumab plus neoadjuvant chemotherapy (NACT) in early-stage breast cancer is likely to be successful in a 300-patient, confirmatory randomized phase 3 neoadjuvant clinical trial.
Design, Setting, and Participants


The I-SPY2 study is an ongoing open-label, multicenter, adaptively randomized phase 2 platform trial for high-risk, stage II/III breast cancer, evaluating multiple investigational arms in parallel. Standard NACT serves as the common control arm; investigational agent(s) are added to this backbone. Patients with ERBB2 (formerly HER2)-negative breast cancer were eligible for randomization to pembrolizumab between November 2015 and November 2016.
Interventions


Participants were randomized to receive taxane- and anthracycline-based NACT with or without pembrolizumab, followed by definitive surgery.
Main Outcomes and Measures


The primary end point was pathologic complete response (pCR). Secondary end points were residual cancer burden (RCB) and 3-year event-free and distant recurrence-free survival. Investigational arms graduated when demonstrating an 85% predictive probability of success in a hypothetical confirmatory phase 3 trial.
Results


Of the 250 women included in the final analysis, 181 were randomized to the standard NACT control group (median [range] age, 47 [24.77] years). Sixty-nine women (median [range] age, 50 [27-71] years) were randomized to 4 cycles of pembrolizumab in combination with weekly paclitaxel followed by AC; 40 hormone receptor (HR)-positive and 29 triple-negative. Pembrolizumab graduated in all 3 biomarker signatures studied. Final estimated pCR rates, evaluated in March 2017, were 44% vs 17%, 30% vs 13%, and 60% vs 22% for pembrolizumab vs control in the ERBB2-negative, HR-positive/ERBB2-negative, and triple-negative cohorts, respectively. Pembrolizumab shifted the RCB distribution to a lower disease burden for each cohort evaluated. Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%). Achieving a pCR appeared predictive of long-term outcome, where patients with pCR following pembrolizumab plus chemotherapy had high event-free survival rates (93% at 3 years with 2.8 years' median follow-up).
Conclusions and Relevance


When added to standard neoadjuvant chemotherapy, pembrolizumab more than doubled the estimated pCR rates for both HR-positive/ERBB2-negative and triple-negative breast cancer, indicating that checkpoint blockade in women with early-stage, high-risk, ERBB2-negative breast cancer is highly likely to succeed in a phase 3 trial. Pembrolizumab was the first of 10 agents to graduate in the HR-positive/ERBB2-negative signature.
Trial Registration


ClinicalTrials.gov Identifier: NCT01042379.",2020,"Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%).","['250 women included in the final analysis', 'patients with early-stage breast cancer who receive', 'Women With Early-Stage Breast Cancer', 'early-stage breast cancer', 'median [range] age, 50 [27-71] years', 'Patients with ERBB2 (formerly HER2)-negative breast cancer were eligible for randomization to pembrolizumab between November 2015 and November 2016', 'Sixty-nine women']","['standard NACT control', 'pembrolizumab in combination with weekly paclitaxel followed by AC; 40 hormone receptor (HR)-positive and 29 triple-negative', 'pembrolizumab plus neoadjuvant chemotherapy (NACT', 'Pembrolizumab', 'taxane- and anthracycline-based NACT with or without pembrolizumab, followed by definitive surgery', 'pembrolizumab plus chemotherapy', 'pembrolizumab', 'Pembrolizumab Plus Neoadjuvant Chemotherapy']","['Pathologic Complete Response', 'adrenal insufficiency', 'pCR rates', 'high event-free survival rates', 'residual cancer burden (RCB) and 3-year event-free and distant recurrence-free survival', 'pathologic complete response (pCR', 'immune-related endocrinopathies, notably thyroid abnormalities']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001623', 'cui_str': 'Adrenal Insufficiency'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242594', 'cui_str': 'Residual Cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",69.0,0.270206,"Adverse events included immune-related endocrinopathies, notably thyroid abnormalities (13.0%) and adrenal insufficiency (8.7%).","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Minetta C', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Yau', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Shatsky', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wallace', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'A Jo', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'University of Alabama, Birmingham.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ellis', 'Affiliation': 'Swedish Cancer Center.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, Illinois.'}, {'ForeName': 'Judy C', 'Initials': 'JC', 'LastName': 'Boughey', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nora T', 'Initials': 'NT', 'LastName': 'Jaskowiak', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Elias', 'Affiliation': 'University of Colorado, Aurora.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Georgetown University, Washington, DC.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kemmer', 'Affiliation': 'Oregon Health & Science University, Portland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Helsten', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Majure', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Stringer-Reasor', 'Affiliation': 'University of Alabama, Birmingham.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Parker', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Tufia', 'Initials': 'T', 'LastName': 'Haddad', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ronald N', 'Initials': 'RN', 'LastName': 'Cohen', 'Affiliation': 'The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Gillian L', 'Initials': 'GL', 'LastName': 'Hirst', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Singhrao', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Steeg', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Asare', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California.'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Matthews', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sanil', 'Affiliation': 'Berry Consultants, LLC.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'University of California, San Diego.'}, {'ForeName': 'W Fraser', 'Initials': 'WF', 'LastName': 'Symmans', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': ""van 't Veer"", 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Yee', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melisko', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Perlmutter', 'Affiliation': 'Gemini Group, Ann Arbor, Michigan.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'University of California, San Francisco.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6650']
215,31915208,Combined use of contact aspiration and the stent retriever technique versus stent retriever alone for recanalization in acute cerebral infarction: the randomized ASTER 2 study protocol.,"RATIONALE


Mechanical thrombectomy (MT) using a stent retriever (SR) device is currently the recommended treatment in ischemic stroke due to anterior circulation large vessel occlusion. Combining contact aspiration (CA) with SR is a promising new treatment, although it was not found to be superior to SR alone as first-line treatment for achieving successful reperfusion.
AIM


To determine whether endovascular treatment combining first-line use of CA and SR is more efficient than SR alone.
METHODS


The ASTER 2 clinical trial is a prospective, randomized, multicenter, open-label trial with a blinded endpoint. We included patients admitted with suspected anterior circulation ischemic stroke secondary to large vessel occlusion <8 hours from symptom onset. They were randomly allocated in a 1:1 ratio to one of two treatment groups (combined CA and SR or SR alone). In the case of failure of the assigned technique after three attempts, other adjunctive techniques were applied.
STUDY OUTCOME


The primary outcome is the rate of successful/complete reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score 2c/3) after the entire endovascular procedure. Secondary outcomes include reperfusion rates after the assigned first-line intervention alone and at the end of the procedure, procedural times, change in NIH Stroke Scale score at 24 hours, intracerebral hemorrhage at 24 hours, procedure-related serious adverse events, the modified Rankin Scale score, and all-cause mortality at 90 days and 1 year. The cost effectiveness of the two procedures will also be analyzed.
DISCUSSION


This is the first head-to-head randomized trial to directly compare the efficacy of the combined use of CA and SR versus SR alone. This prospective trial aims to demonstrate the synergistic effects of CA and SR devices in first-line endovascular treatment.",2020,The primary outcome is the rate of successful/complete reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score 2c/3) after the entire endovascular procedure.,"['patients admitted with suspected anterior circulation ischemic stroke secondary to large vessel occlusion <8 hours from symptom onset', 'acute cerebral infarction']","['CA and SR devices', 'stent retriever (SR) device', 'contact aspiration and the stent retriever technique versus stent retriever alone', 'CA and SR', 'Combining contact aspiration (CA) with SR', 'CA and SR versus SR alone']","['procedure, procedural times, change in NIH Stroke Scale score at 24 hours, intracerebral hemorrhage at 24 hours, procedure-related serious adverse events, the modified Rankin Scale score, and all-cause mortality', 'rate of successful/complete reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score 2c/3', 'cost effectiveness', 'reperfusion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0324426', 'cui_str': 'Retriever'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0433084,The primary outcome is the rate of successful/complete reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score 2c/3) after the entire endovascular procedure.,"[{'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Stroke Center Neurology Division, Hôpital Foch, Suresnes, France b.lapergue@hopital-foch.org.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, University of Lille, CHU Lille, Lille, France.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Gaultier', 'Initials': 'G', 'LastName': 'Marnat', 'Affiliation': 'Interventional and Diagnostic Neuroradiology, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Consoli', 'Affiliation': 'Interventional Neuroradiologie, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Rodesch', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Saleme', 'Affiliation': 'University Hospital of Limoges, Limoges, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Costalat', 'Affiliation': 'Neuroradiology, CHRU Gui de Chauliac, Montpellier, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Bracard', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, CHRU Nancy, Hôpital Central Nancy, Nancy, France.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Desal', 'Affiliation': 'Neuroradiology, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'Biostatistics, University of Lille, Lille, France.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Mazighi', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Spelle', 'Affiliation': 'Department of Diagnostic and Therapeutic Neuroradiology, Hôpitaux Universitaires Paris-Sud, Hôpital du Kremlin-Bicetre, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Interventional Neuroradiology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Eimad', 'Initials': 'E', 'LastName': 'Shotar', 'Affiliation': 'Department of Neuroradiology, Pitié-Salpêtrière Hospital, APHP, Paris, France.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Ben Maacha', 'Affiliation': 'Biostatistics, Fondation Rothschild Hospital, Paris, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Ferre', 'Affiliation': 'Radiology Department, University Hospital University Rennes Inria CNRS INSERM, Rennes F30533, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Prevot', 'Affiliation': 'Clinical Research Department, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, CHRU Nancy, Nancy, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-014735']
216,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN


Parallel-group, quasi-experimental study.
OBJECTIVES


To evaluate the effectiveness of a coping-oriented supportive programme (COSP) for people with spinal cord injury (SCI) over a 12-week follow-up.
SETTING


SCI wards in two rehabilitation hospitals of Shaanxi, China.
METHODS


Ninety-nine participants (mean age = 41, 88% males and 74% paraplegia) joined the COSP intervention (n = 50) or attention control (n = 49) group. The COSP intervention was focussed on the facilitation of coping skills and consisted of 8 weekly sessions, whereas the attentional control group was provided with 8 weekly didactic education sessions. Effects of the COSP intervention were determined by primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain). Data were collected at pre- and post-intervention, as well as 4- and 12-week follow-up.
RESULTS


Intention to treat analysis indicated statistically significant effects (with moderate to large effect sizes, all P-values < 0.01) on participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction immediately post-COSP. Statistically significant effects were found for maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction at 4-week follow-up. Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
CONCLUSION


The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
217,31944221,Effect of Dasatinib vs Imatinib in the Treatment of Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Randomized Clinical Trial.,"Importance


A randomized clinical trial is needed to determine whether the second-generation Abl-tyrosine kinase inhibitor dasatinib is more effective than the first-generation inhibitor imatinib mesylate for childhood Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).
Objective


To determine whether dasatinib given at a daily dosage of 80 mg/m2 is more effective than imatinib mesylate at a daily dosage of 300 mg/m2 to improve event-free survival of children with Philadelphia chromosome-positive ALL in the context of intensive chemotherapy without prophylactic cranial irradiation.
Design, Setting, and Participants


This open-label, phase 3 randomized clinical trial was conducted at 20 hospitals in China. Enrollment occurred from January 1, 2015, through September 18, 2018, and randomization was stopped on October 4, 2018, when the early stopping criterion of the trial was met. Patients aged 0 to 18 years were recruited. Of the 225 patients with the diagnosis, 35 declined participation and 1 died before treatment, leaving 189 patients available for analysis. Data were analyzed from January 1 through August 4, 2019.
Interventions


Patients were randomized to receive daily dasatinib (n = 92) or imatinib (n = 97) continuously for the entire duration of ALL therapy from the time of diagnosis made during remission induction to the end of continuation therapy.
Main Outcomes and Measures


The primary outcome was event-free survival, analyzed based on intention to treat. The secondary outcomes were relapse, death due to toxic effects, and overall survival.
Results


Among the 189 participants (136 male [72.0%]; median age, 7.8 [interquartile range (IQR), 5.2-11.3] years) and a median follow-up of 26.4 (IQR, 16.3-34.1) months, the 4-year event-free survival and overall survival rates were 71.0% (95% CI, 56.2%-89.6%) and 88.4% (95% CI, 81.3%-96.1%), respectively, in the dasatinib group and 48.9% (95% CI, 32.0%-74.5%; P = .005, log-rank test) and 69.2% (95% CI, 55.6%-86.2%; P = .04, log-rank test), respectively, in the imatinib group. The 4-year cumulative risk of any relapse was 19.8% (95% CI, 4.2%-35.4%) in the dasatinib group and 34.4% (95% CI, 15.6%-53.2%) in the imatinib group (P = .01, Gray test), whereas the 4-year cumulative risk of an isolated central nervous system relapse was 2.7% (95% CI, 0.0%-8.1%) in the dasatinib group and 8.4% (95% CI, 1.2%-15.6%) in the imatinib group (P = .06, Gray test). There were no significant differences in the frequency of severe toxic effects between the 2 treatment groups.
Conclusions and Relevance


Intensive chemotherapy including dasatinib at a dosage of 80 mg/m2 per day yielded superior results in the treatment of Philadelphia chromosome-positive ALL compared with imatinib mesylate at a dosage of 300 mg/m2 per day and provided excellent control of central nervous system leukemia without the use of prophylactic cranial irradiation.
Trial Registration


Chinese Clinical Trial Registry: ChiCTR-IPR-14005706.",2020,"There were no significant differences in the frequency of severe toxic effects between the 2 treatment groups.
","['20 hospitals in China', '225 patients with the diagnosis, 35 declined participation and 1 died before treatment, leaving 189 patients available for analysis', 'Pediatric Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia', 'childhood Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL', 'children with Philadelphia chromosome-positive ALL in the context of intensive chemotherapy without prophylactic cranial irradiation', '189 participants (136 male [72.0%]; median age, 7.8 [interquartile range (IQR), 5.2-11.3] years', 'Patients aged 0 to 18 years were recruited']","['Dasatinib vs Imatinib', 'daily dasatinib (n\u2009=\u200992) or imatinib', 'imatinib mesylate']","['frequency of severe toxic effects', 'event-free survival', '4-year event-free survival and overall survival rates', '4-year cumulative risk of any relapse', '4-year cumulative risk of an isolated central nervous system relapse', 'relapse, death due to toxic effects, and overall survival']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1709527', 'cui_str': 'Ph+ acute lymphoblastic leukemia'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0856536', 'cui_str': 'Philadelphia chromosome positive'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0939537', 'cui_str': 'Imatinib mesylate'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",189.0,0.392935,"There were no significant differences in the frequency of severe toxic effects between the 2 treatment groups.
","[{'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': ""National Children's Medical Center, Department of Hematology/Oncology, Key Laboratory of Pediatric Hematology and Oncology of China Ministry of Health, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Experimental Hematology and Division of Pediatric Blood Diseases Center, Institute of Hematology and Blood Diseases Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Jiaoyang', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': ""National Children's Medical Center, Department of Hematology/Oncology, Key Laboratory of Pediatric Hematology and Oncology of China Ministry of Health, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Department of Hematology/Oncology, Chongqing Medical University Affiliated Children's Hospital, Chongqing, China.""}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatrics, Key Laboratory of Birth Defects and Related Disease of Women and Children, Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""Department of Hematology/Oncology, Children's Hospital of Soochow University, Suzhou, China.""}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Zhai', 'Affiliation': ""Department of Hematology/Oncology, Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Changda', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': ""Department of Hematology/Oncology, Jiangxi Provincial Children's Hospital, Nanchang, China.""}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Ju', 'Affiliation': 'Department of Pediatrics, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Department of Hematology/Oncology, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Runming', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Pediatrics, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Anhui Medical University Second Affiliated Hospital, Anhui, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': ""Department of Hematology/Oncology, Kunming Children's Hospital, Kunming, China.""}, {'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Pan', 'Affiliation': ""Department of Hematology/Oncology, Xi'an Northwest Women and Children Hospital, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': ""Department of Hematology/Oncology, Shanghai Children's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Pediatrics, Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Hematology/Oncology, Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Chi-Kong', 'Initials': 'CK', 'LastName': 'Li', 'Affiliation': ""Department of Pediatrics, Hong Kong Children's Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Pediatrics, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Xiangya Hospital Central South University, Changsha, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Pediatrics, Key Laboratory of Birth Defects and Related Disease of Women and Children, Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology/Oncology, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Chunfu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Deqing', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': ""Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': ""National Children's Medical Center, Department of Hematology/Oncology, Key Laboratory of Pediatric Hematology and Oncology of China Ministry of Health, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Experimental Hematology and Division of Pediatric Blood Diseases Center, Institute of Hematology and Blood Diseases Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}]",JAMA oncology,['10.1001/jamaoncol.2019.5868']
218,31957963,"Intraaortic balloon pump in myocardial infarction: Always, Never, or for the Right Patient?",SEMPER FI was a 100-patient pilot study that randomized acute myocardial infarction (AMI) patients with persistent ischemia following percutaneous coronary intervention (PCI) to intraaortic balloon pump (IABP) versus control. AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events. These results support a larger adequately powered trial of IABP versus control in AMI patients with persistent ischemia following primary PCI.,2020,AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events.,"['AMI patients with persistent ischemia receiving short-term IABP post-PCI', 'myocardial infarction', 'AMI patients with persistent ischemia following primary PCI']","['percutaneous coronary intervention (PCI) to intraaortic balloon pump (IABP', 'Intraaortic balloon pump', 'IABP']",['resolution of persistent ST segment elevation'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump, device (physical object)'}]","[{'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}]",,0.0672327,AMI patients with persistent ischemia receiving short-term IABP post-PCI had a greater resolution of persistent ST segment elevation and a trend for decreased clinical events.,"[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Tyler', 'Affiliation': 'Cardiovascular Division, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28683']
219,30535398,"Impact of chronic dietary red meat, white meat, or non-meat protein on trimethylamine N-oxide metabolism and renal excretion in healthy men and women.","AIMS


Carnitine and choline are major nutrient precursors for gut microbiota-dependent generation of the atherogenic metabolite, trimethylamine N-oxide (TMAO). We performed randomized-controlled dietary intervention studies to explore the impact of chronic dietary patterns on TMAO levels, metabolism and renal excretion.
METHODS AND RESULTS


Volunteers (N = 113) were enrolled in a randomized 2-arm (high- or low-saturated fat) crossover design study. Within each arm, three 4-week isocaloric diets (with washout period between each) were evaluated (all meals prepared in metabolic kitchen with 25% calories from protein) to examine the effects of red meat, white meat, or non-meat protein on TMAO metabolism. Trimethylamine N-oxide and other trimethylamine (TMA) related metabolites were quantified at the end of each diet period. A random subset (N = 13) of subjects also participated in heavy isotope tracer studies. Chronic red meat, but not white meat or non-meat ingestion, increased plasma and urine TMAO (each >two-fold; P < 0.0001). Red meat ingestion also significantly reduced fractional renal excretion of TMAO (P < 0.05), but conversely, increased fractional renal excretion of carnitine, and two alternative gut microbiota-generated metabolites of carnitine, γ-butyrobetaine, and crotonobetaine (P < 0.05). Oral isotope challenge revealed red meat or white meat (vs. non-meat) increased TMA and TMAO production from carnitine (P < 0.05 each) but not choline. Dietary-saturated fat failed to impact TMAO or its metabolites.
CONCLUSION


Chronic dietary red meat increases systemic TMAO levels through: (i) enhanced dietary precursors; (ii) increased microbial TMA/TMAO production from carnitine, but not choline; and (iii) reduced renal TMAO excretion. Discontinuation of dietary red meat reduces plasma TMAO within 4 weeks.",2019,"Red meat ingestion also significantly reduced fractional renal excretion of TMAO (P < 0.05), but conversely, increased fractional renal excretion of carnitine, and two alternative gut microbiota-generated metabolites of carnitine, γ-butyrobetaine, and crotonobetaine (P < 0.05).","['A random subset (N\u2009=\u200913) of subjects also participated in heavy isotope tracer studies', 'healthy men and women', 'Volunteers (N\u2009=\u2009113']","['chronic dietary red meat, white meat, or non-meat protein', 'dietary red meat', 'Trimethylamine N-oxide and other trimethylamine (TMA', 'red meat, white meat, or non-meat protein']","['systemic TMAO levels through: (i) enhanced dietary precursors; (ii) increased microbial TMA/TMAO production', 'renal TMAO excretion', 'red meat or white meat', 'TMAO levels, metabolism and renal excretion', 'TMA and TMAO production', 'plasma and urine TMAO', 'fractional renal excretion of carnitine, and two alternative gut microbiota-generated metabolites of carnitine, γ-butyrobetaine, and crotonobetaine', 'fractional renal excretion of TMAO']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0022262', 'cui_str': 'Isotopes'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C3486452', 'cui_str': 'Meat Proteins'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0077172', 'cui_str': 'trimethylamine'}, {'cui': 'C0301363', 'cui_str': '5-Trimethoxyamphetamine (substance)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0077194', 'cui_str': 'trimethylammonium oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0301363', 'cui_str': '5-Trimethoxyamphetamine (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042037'}, {'cui': 'C0696229', 'cui_str': 'Carnitine'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0061030', 'cui_str': 'deoxy-carnitine'}, {'cui': 'C0056526', 'cui_str': 'crotonobetaine'}]",113.0,0.0199889,"Red meat ingestion also significantly reduced fractional renal excretion of TMAO (P < 0.05), but conversely, increased fractional renal excretion of carnitine, and two alternative gut microbiota-generated metabolites of carnitine, γ-butyrobetaine, and crotonobetaine (P < 0.05).","[{'ForeName': 'Zeneng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bergeron', 'Affiliation': ""Department of Atherosclerosis Research, Children's Hospital Oakland Research Institute, Martin Luther King Jr Way, Oakland, CA, USA.""}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Levison', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Xinmin S', 'Initials': 'XS', 'LastName': 'Li', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': ""Department of Atherosclerosis Research, Children's Hospital Oakland Research Institute, Martin Luther King Jr Way, Oakland, CA, USA.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Koeth', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Mathematics, Cleveland State University, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': ""Department of Atherosclerosis Research, Children's Hospital Oakland Research Institute, Martin Luther King Jr Way, Oakland, CA, USA.""}, {'ForeName': 'Stanley L', 'Initials': 'SL', 'LastName': 'Hazen', 'Affiliation': 'Department of Cellular and Molecular Medicine, Lerner Research Institute, Cleveland Clinic, Euclid Ave, Cleveland, OH, USA.'}]",European heart journal,['10.1093/eurheartj/ehy799']
220,32056721,Efficacy and safety of inhaled once-daily low-dose indacaterol acetate/mometasone furoate in patients with inadequately controlled asthma: Phase III randomised QUARTZ study findings.,"BACKGROUND


Global initiative for asthma (GINA) 2019 recommends adding a long-acting β 2 -agonist (LABA) to an inhaled corticosteroid (ICS) as a maintenance controller therapy in patients with inadequately controlled asthma. Indacaterol acetate (IND, a LABA) in combination with mometasone furoate (MF, an ICS) is under development for the treatment of these patients.
OBJECTIVE


This phase III QUARTZ was a multicentre, randomised, double-blind, double-dummy and parallel-group study to assess the efficacy and safety of low-dose IND/MF 150/80 μg once daily (o.d.) versus MF 200 μg o.d. in adult and adolescent patients with inadequately controlled asthma.
METHODS


Eligible patients (n = 802) were randomised (1:1) to receive either low-dose IND/MF 150/80 μg o.d. via Breezhaler® or MF 200 μg o.d. via Twisthaler® for 12 weeks. Primary endpoint was trough forced expiratory volume in 1 s (FEV 1 ) and key secondary endpoint was Asthma Control Questionnaire (ACQ-7) treatment difference after 12-week treatment. Other secondary endpoints included ACQ-7 responder analysis, morning and evening peak expiratory flow, Asthma Quality of Life Questionnaire total score, rescue medication use, daily symptom score, nighttime awakenings and rate of exacerbations, evaluated over 12-week treatment. Safety was also assessed including serious asthma outcomes.
RESULTS


Low-dose IND/MF significantly improved trough FEV 1  (least squares mean treatment difference [LSMTD]: 0.182 L; p < 0.001) and ACQ-7 (LSMTD: -0.218; p < 0.001) versus MF at Week 12. Improvements in all other secondary endpoints favoured low-dose IND/MF. Safety was comparable.
CONCLUSION


These results support the use of low-dose IND/MF 150/80 μg o.d. as a potential therapy for adult and adolescent patients with inadequately controlled asthma.",2020,"Safety was comparable.
","['asthma', 'Eligible patients (n\u202f=\u202f802', 'patients with inadequately controlled asthma', 'adult and adolescent patients with inadequately controlled asthma']","['low-dose IND/MF 150/80\u202fμg o.d. via Breezhaler® or MF 200\u202fμg', 'inhaled corticosteroid (ICS', 'Indacaterol acetate (IND, a LABA', 'LSMTD', 'low-dose IND/MF', 'mometasone furoate (MF, an ICS', 'inhaled once-daily low-dose indacaterol acetate/mometasone furoate']","['efficacy and safety', 'Efficacy and safety', 'serious asthma outcomes', 'trough forced expiratory volume in 1\u202fs (FEV 1 ) and key secondary endpoint was Asthma Control Questionnaire (ACQ-7) treatment difference', 'low-dose IND/MF', 'ACQ-7 responder analysis, morning and evening peak expiratory flow, Asthma Quality of Life Questionnaire total score, rescue medication use, daily symptom score, nighttime awakenings and rate of exacerbations', 'Safety']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",802.0,0.406845,"Safety was comparable.
","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany. Electronic address: kornmann@ikf-pneumologie.de.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Mucsi', 'Affiliation': 'Erzsébet Gondozóház, Gödöllő, Hungary. Electronic address: mucsitrial@erzsebetgondozohaz.hu.'}, {'ForeName': 'Nadezda', 'Initials': 'N', 'LastName': 'Kolosa', 'Affiliation': 'Daugavpils Regional Hospital LTD, Daugavpils, Latvia. Electronic address: kolosa-nadezda@hotmail.com.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bandelli', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: lorraine.bandelli@novartis.com.'}, {'ForeName': 'Biswajit', 'Initials': 'B', 'LastName': 'Sen', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India. Electronic address: biswajit.sen@novartis.com.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Satlin', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: lisa.satlin@novartis.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""D'Andrea"", 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Electronic address: peter.dandrea@novartis.com.'}]",Respiratory medicine,['10.1016/j.rmed.2019.105809']
221,31703120,Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Chronic kidney disease (CKD) is a common complication of type 2 diabetes that can lead to end-stage kidney disease and is associated with high cardiovascular risk. Few treatments are available to prevent CKD in type 2 diabetes.
Objective


To test whether supplementation with vitamin D3 or omega-3 fatty acids prevents development or progression of CKD in type 2 diabetes.
Design, Setting, and Participants


Randomized clinical trial with a 2 × 2 factorial design conducted among 1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial (VITAL), coordinated by a single center in Massachusetts. Follow-up was completed in December 2017.
Interventions


Participants were randomized to receive vitamin D3 (2000 IU/d) and omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid; 1 g/d) (n = 370), vitamin D3 and placebo (n = 333), placebo and omega-3 fatty acids (n = 289), or 2 placebos (n = 320) for 5 years.
Main Outcomes and Measures


The primary outcome was change in glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR) from baseline to year 5.
Results


Among 1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study. Baseline mean eGFR was 85.8 (SD, 22.1) mL/min/1.73 m2. Mean change in eGFR from baseline to year 5 was -12.3 (95% CI, -13.4 to -11.2) mL/min/1.73 m2 with vitamin D3 vs -13.1 (95% CI, -14.2 to -11.9) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.5] mL/min/1.73 m2). Mean change in eGFR was -12.2 (95% CI, -13.3 to -11.1) mL/min/1.73 m2 with omega-3 fatty acids vs -13.1 (95% CI, -14.2 to -12.0) mL/min/1.73 m2 with placebo (difference, 0.9 [95% CI, -0.7 to 2.6] mL/min/1.73 m2). There was no significant interaction between the 2 interventions. Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
Conclusions and Relevance


Among adults with type 2 diabetes, supplementation with vitamin D3 or omega-3 fatty acids, compared with placebo, resulted in no significant difference in change in eGFR at 5 years. The findings do not support the use of vitamin D or omega-3 fatty acid supplementation for preserving kidney function in patients with type 2 diabetes.
Trial Registration


ClinicalTrials.gov Identifier: NCT01684722.",2019,"Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
","['1312 participants randomized (mean age, 67.6 years; 46% women; 31% of racial or ethnic minority), 934 (71%) completed the study', 'adults with type 2 diabetes', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes', 'Importance\n\n\nChronic kidney disease (CKD', '1312 adults with type 2 diabetes recruited between November 2011 and March 2014 from all 50 US states as an ancillary study to the Vitamin D and Omega-3 Trial']","['Vitamin D and Omega-3 Fatty Acid Supplementation', 'omega-3 fatty acids (eicosapentaenoic acid and docosahexaenoic acid', 'vitamin D3 and placebo', 'omega-3 fatty acids and n\u2009=\u200917 receiving placebo', 'vitamin D3 or omega-3 fatty acids', ' mL', 'placebo', 'mL', 'vitamin D3', 'placebo and omega-3 fatty acids (n\u2009=\u2009289), or 2 placebos', 'omega-3 fatty acids', 'vitamin D or omega-3 fatty acid supplementation']","['Kidney stones', 'gastrointestinal bleeding', 'Mean change in eGFR', 'Baseline mean eGFR', 'Kidney Function', 'change in eGFR', 'glomerular filtration rate estimated from serum creatinine and cystatin C (eGFR', 'kidney function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}]",1312.0,0.488501,"Kidney stones occurred among 58 participants (n = 32 receiving vitamin D3 and n = 26 receiving placebo) and gastrointestinal bleeding among 45 (n = 28 receiving omega-3 fatty acids and n = 17 receiving placebo).
","[{'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Leila R', 'Initials': 'LR', 'LastName': 'Zelnick', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ruzinski', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Duszlak', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vadim Y', 'Initials': 'VY', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Hoofnagle', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Washington, Seattle.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Thadhani', 'Affiliation': 'Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2019.17380']
222,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE


In 2014, our institution launched a randomized controlled trial (RCT) comparing rapid genome sequencing (GS) to standard clinical evaluations of infants with suspected genetic disorders. This study aimed to understand parental response to the use of GS for their newborn babies.
METHODS


Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information. We also collected information about participants' genetic literacy, genetic knowledge, numeracy, and symptoms of anxiety and depression.
RESULTS


The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial. The 12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information. Some reported the diagnosis led to changes in medical care. Participants showed understanding of some of the psychological risks of GS. For example, 21 (91.3%) agreed or strongly agreed that genetic testing could reveal disturbing results.
CONCLUSIONS


Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
223,32108442,Effect of Plain Versus Sugar-Sweetened Breakfast on Energy Balance and Metabolic Health: A Randomized Crossover Trial.,"OBJECTIVE


This study investigated the effect of 3 weeks of high-sugar (""Sweet"") versus low-sugar (""Plain"") breakfast on energy balance, metabolic health, and appetite.
METHODS


A total of 29 healthy adults (22 women) completed this randomized crossover study. Participants had pre- and postintervention appetite, health, and body mass outcomes measured, and they recorded diet, appetite (visual analogue scales), and physical activity for 8 days during each intervention. Interventions were 3 weeks of isoenergetic Sweet (30% by weight added sugar; average 32 g of sugar) versus Plain (no added sugar; average 8 g of sugar) porridge-based breakfasts.
RESULTS


Pre- to postintervention changes in body mass were similar between Plain (Δ 0.1 kg; 95% CI: -0.3 to 0.5 kg) and Sweet (Δ 0.2 kg; 95% CI: -0.2 to 0.5 kg), as were pre- to postintervention changes for biomarkers of health (all P ≥ 0.101) and psychological appetite (all P ≥ 0.152). Energy, fat, and protein intake was not statistically different between conditions. Total carbohydrate intake was higher during Sweet (287 ± 82 g/d vs. 256 ± 73 g/d; P = 0.009), driven more by higher sugar intake at breakfast (116 ± 46 g/d vs. 88 ± 38 g/d; P < 0.001) than post-breakfast sugar intake (Sweet 84 ± 42 g/d vs. Plain 80 ± 37 g/d; P = 0.552). Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
CONCLUSIONS


Energy balance, health markers, and appetite did not respond differently to 3 weeks of high- or low-sugar breakfasts.",2020,"Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
",['29 healthy adults (22 women'],"['Plain Versus Sugar-Sweetened Breakfast', 'isoenergetic Sweet (30% by weight added sugar', 'high-sugar (""Sweet"") versus low-sugar (""Plain"") breakfast', 'Plain (no added sugar; average 8 g of\xa0sugar) porridge-based breakfasts']","['body mass', 'reduced sweet desire', 'psychological appetite', 'Energy Balance and Metabolic Health', 'Energy, fat, and protein intake', 'diet, appetite (visual analogue scales), and physical activity', 'energy balance, metabolic health, and appetite', 'Total carbohydrate intake']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0452575', 'cui_str': 'Porridge (substance)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",29.0,0.323909,"Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001).
","[{'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'Templeman', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Wharton', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Department of Life Sciences, University of Roehampton, London, UK.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Trim', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Enhad A', 'Initials': 'EA', 'LastName': 'Chowdhury', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Brunstrom', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'School for Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22757']
224,32227753,Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.,"BACKGROUND


In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.
METHODS


We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.
RESULTS


At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).
CONCLUSIONS


In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","['Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease', 'patients with stable ischemic heart disease and moderate or severe ischemia']",['invasive treatment strategy (2295 participants) or a conservative strategy'],"['angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ', 'SAQ summary score (scores range', 'SAQ summary scores', 'angina-related health status']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.248293,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Khaula', 'Initials': 'K', 'LastName': 'Baloch', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916370']
225,31588607,Improving fitness increases dentate gyrus/CA3 volume in the hippocampal head and enhances memory in young adults.,"Converging evidence suggests a relationship between aerobic exercise and hippocampal neuroplasticity that interactively impacts hippocampally dependent memory. The majority of human studies have focused on the potential for exercise to reduce brain atrophy and attenuate cognitive decline in older adults, whereas animal studies often center on exercise-induced neurogenesis and hippocampal plasticity in the dentate gyrus (DG) of young adult animals. In the present study, initially sedentary young adults (18-35 years) participated in a moderate-intensity randomized controlled exercise intervention trial (ClinicalTrials.gov; NCT02057354) for a duration of 12 weeks. The aims of the study were to investigate the relationship between change in cardiorespiratory fitness (CRF) as determined by estimated  V   ˙   O   2     MAX  , hippocampally dependent mnemonic discrimination, and change in hippocampal subfield volume. Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults. Consistent with previous studies that found exercise-induced increases in anterior hippocampus in older adults, this result was specific to the hippocampal head, or most anterior portion, of the subregion. Our results also demonstrate a positive relationship between change in CRF and change in corrected accuracy for trials requiring the highest level of discrimination on a putative behavioral pattern separation task. This relationship was observed in individuals who were initially lower-fit, suggesting that individuals who show greater improvement in their CRF may receive greater cognitive benefit. This work extends animal models by providing evidence for exercise-induced neuroplasticity specific to the neurogenic zone of the human hippocampus.",2020,Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults.,"['young adults', 'older adults', 'initially sedentary young adults (18-35\u2009years) participated in a moderate-intensity randomized']",['controlled exercise intervention'],"['anterior hippocampus', 'cardiorespiratory fitness (CRF']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]",,0.0561769,Results show that improving CRF after exercise training is associated with an increased volume in the left DG/CA3 subregion in young adults.,"[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nauer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Dunne', 'Affiliation': 'Center for Systems Neuroscience, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Chantal E', 'Initials': 'CE', 'LastName': 'Stern', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schon', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}]",Hippocampus,['10.1002/hipo.23166']
226,31896568,Does Increasing Packing Density Using Larger Caliber Coils Improve Angiographic Results of Embolization of Intracranial Aneurysms at 1 Year: A Randomized Trial.,"BACKGROUND AND PURPOSE


The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year.
MATERIALS AND METHODS


Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils.
RESULTS


Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644;  P  = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%,  P  = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022;  P  = .879).
CONCLUSIONS


Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.",2020,"CONCLUSIONS


Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.","['Patients had 4- to 12-mm unruptured aneurysms', 'Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA', '564 patients', '210 patients were recruited between November 2013 and June 2017']",['10-caliber coils (control group'],"['initial angiographic results', 'major recurrence or a residual aneurysm', 'mean packing density', 'indices of treatment success and standard safety outcomes', 'higher packing densities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",564.0,0.237219,"CONCLUSIONS


Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada jean.raymond@Umontreal.ca.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghostine', 'Affiliation': ""From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'van Adel', 'Affiliation': 'Department of Surgery/Medicine (B.A.v.A), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'J J S', 'Initials': 'JJS', 'LastName': 'Shankar', 'Affiliation': 'Department of Radiology (J.J.S.S.), University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Iancu', 'Affiliation': 'Department of Radiology, Service of Interventional Neuroradiology (D.I.), University of Ottawa Hospitals, Civic Campus, Ottawa, Ontario, Canada.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Mitha', 'Affiliation': 'Department of Clinical Neurosciences (A.P.M.), University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kvamme', 'Affiliation': 'Department of Radiology (P.K.), University of Tennessee Medical Center, Knoxville, Tennessee.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Turner', 'Affiliation': 'Department of Neurosurgery (R.D.T., A.T.), Prisma Health-Upstate, Greenville, South Carolina.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Turk', 'Affiliation': 'Department of Neurosurgery (R.D.T., A.T.), Prisma Health-Upstate, Greenville, South Carolina.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mendes-Pereira', 'Affiliation': 'Division of Neuroradiology (V.M.-P.), Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Carpenter', 'Affiliation': 'Department of Neuroradiology (J.S.C., S.B.), West Virginia University, Rockefeller Neuroscience Institute, Morgantown, West Virginia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boo', 'Affiliation': 'Department of Neuroradiology (J.S.C., S.B.), West Virginia University, Rockefeller Neuroscience Institute, Morgantown, West Virginia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Department of Interventional Neuroradiology (A.E.), University of Virginia Medical Center, Charlottesville, Virginia.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Woo', 'Affiliation': 'Departments of Neurosurgery and Radiology, Northwell Health System (H.H.W., D.F.), Manhasset, New York.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Departments of Neurosurgery and Radiology, Northwell Health System (H.H.W., D.F.), Manhasset, New York.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alaraj', 'Affiliation': 'Department of Neurosurgery (A.A.), University of Illinois Hospital and Health Sciences System, Chicago, Illinois.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': ""From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Weill', 'Affiliation': ""From the Department of Radiology (J.R., J.G., D.R., A.W.), Service of Interventional Neuroradiology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lavoie', 'Affiliation': 'Department of Neurosurgery (P.L.), Hôpital Enfant-Jésus, Quebec City, Quebec, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chagnon', 'Affiliation': 'Department of Mathematics and Statistics (M.C.), University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'T N', 'Initials': 'TN', 'LastName': 'Nguyen', 'Affiliation': 'Departments of Neurology, Neurosurgery, and Radiology (T.N.N.), Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Rempel', 'Affiliation': 'Department of Radiology and Diagnostic Imaging (J.L.R.).'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Darsaut', 'Affiliation': 'Division of Neurosurgery (T.E.D.), Department of Surgery, Mackenzie Health Sciences Centre, University of Alberta Hospital, Edmonton, Alberta, Canada.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6362']
227,32101256,"Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis: A Phase 2b Randomized Clinical Trial.","Importance


Interleukin 13 (IL-13) is a central pathogenic mediator driving multiple features of atopic dermatitis (AD) pathophysiology.
Objective


To evaluate the efficacy and safety of lebrikizumab, a novel, high-affinity, monoclonal antibody targeting IL-13 that selectively prevents formation of the IL-13Rα1/IL-4Rα heterodimer receptor signaling complex, in adults with moderate to severe AD.
Design, Setting, and Participants


A phase 2b, double-blind, placebo-controlled, dose-ranging randomized clinical trial of lebrikizumab injections every 4 weeks or every 2 weeks was conducted from January 23, 2018, to May 23, 2019, at 57 US centers. Participants were adults 18 years or older with moderate to severe AD.
Interventions


Patients were randomized 2:3:3:3 to placebo every 2 weeks or to subcutaneous injections of lebrikizumab at the following doses: 125 mg every 4 weeks (250-mg loading dose [LD]), 250 mg every 4 weeks (500-mg LD), or 250 mg every 2 weeks (500-mg LD at baseline and week 2).
Main Outcomes and Measures


The primary end point was percentage change in the Eczema Area and Severity Index (EASI) (baseline to week 16). Secondary end points for week 16 included proportion of patients achieving Investigator's Global Assessment score of 0 or 1 (IGA 0/1); EASI improvement of at least 50%, 75%, or 90% from baseline; percentage change in the pruritus numeric rating scale (NRS) score; and pruritus NRS score improvement of at least 4 points. Safety assessments included treatment-emergent adverse events.
Results


A total of 280 patients (mean [SD] age, 39.3 [17.5] years; 166 [59.3%] female) were randomized to placebo (n = 52) or to lebrikizumab at doses of 125 mg every 4 weeks (n = 73), 250 mg every 4 weeks (n = 80), or 250 mg every 2 weeks (n = 75). Compared with placebo (EASI least squares mean [SD] percentage change, -41.1% [56.5%]), lebrikizumab groups showed dose-dependent, statistically significant improvement in the primary end point vs placebo at week 16: 125 mg every 4 weeks (-62.3% [37.3%], P = .02), 250 mg every 4 weeks (-69.2% [38.3%], P = .002), and 250 mg every 2 weeks (-72.1% [37.2%], P < .001). Differences vs placebo-treated patients (2 of 44 [4.5%]) in pruritus NRS improvement of at least 4 points were seen as early as day 2 in the high-dose lebrikizumab group (9 of 59 [15.3%]). Treatment-emergent adverse events were reported in 24 of 52 placebo patients (46.2%) and in lebrikizumab patients as follows: 42 of 73 (57.5%) for 125 mg every 4 weeks, 39 of 80 (48.8%) for 250 mg every 4 weeks, and 46 of 75 (61.3%) for 250 mg every 2 weeks; most were mild to moderate and did not lead to discontinuation. Low rates of injection-site reactions (1 of 52 [1.9%] in the placebo group vs 13 of 228 [5.7%] in all lebrikizumab groups), herpesvirus infections (2 [3.8%] vs 8 [3.5%]), and conjunctivitis (0% vs 6 [2.6%]) were reported.
Conclusions and Relevance


During 16 weeks of treatment, lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe AD and demonstrated a favorable safety profile. These data support the central role of IL-13 in AD pathophysiology. If these findings replicate in phase 3 studies, lebrikizumab may meaningfully advance the standard of care for moderate to severe AD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03443024.",2020,"During 16 weeks of treatment, lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe AD and demonstrated a favorable safety profile.","['adult patients with moderate to severe AD', 'adults with moderate to severe AD', '280 patients (mean [SD] age, 39.3 [17.5] years; 166 [59.3%] female', 'Adults With Moderate to Severe Atopic Dermatitis', 'Participants were adults 18 years or older with moderate to severe AD']","['placebo', 'lebrikizumab', 'Lebrikizumab', 'lebrikizumab injections']","['pruritus NRS improvement', 'percentage change in the Eczema Area and Severity Index (EASI', ""proportion of patients achieving Investigator's Global Assessment score of 0 or 1 (IGA 0/1); EASI improvement"", 'pruritus numeric rating scale (NRS) score; and pruritus NRS score improvement', 'conjunctivitis', 'herpesvirus infections', 'Low rates of injection-site reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2981360', 'cui_str': 'lebrikizumab'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0222045'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0019372', 'cui_str': 'Herpesvirus Infections'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",280.0,0.435473,"During 16 weeks of treatment, lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe AD and demonstrated a favorable safety profile.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Principal Investigator and President, Oregon Medical Research Center, Portland.'}, {'ForeName': 'Lawrence F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': 'Department of Dermatology, University of California, San Diego.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Drew', 'Affiliation': 'Dermira, Inc, Menlo Park, California.'}, {'ForeName': 'Ramanan', 'Initials': 'R', 'LastName': 'Gopalan', 'Affiliation': 'Dermira, Inc, Menlo Park, California.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.0079']
228,32267471,Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial.,"Importance


Risankizumab selectively inhibits interleukin 23, a cytokine that contributes to psoriatic inflammation.
Objective


To evaluate the efficacy and safety of risankizumab vs placebo and continuous treatment vs withdrawal in adults with moderate to severe plaque psoriasis.
Design, Setting, and Participants


Multinational, phase 3, randomized, double-blind, placebo-controlled trial conducted from March 6, 2016, to July 26, 2018. A total of 507 eligible patients had stable moderate to severe chronic plaque psoriasis for 6 months or longer, body surface area involvement greater than or equal to 10%, Psoriasis Area and Severity Index (PASI) greater than or equal to 12, and a static Physician's Global Assessment (sPGA) score greater than or equal to 3. Intention-to-treat analysis was conducted.
Interventions


Patients were randomized (4:1, interactive response technology) to risankizumab, 150 mg, subcutaneously, or placebo at weeks 0 and 4 (part A1). All patients received risankizumab at week 16. At week 28, patients randomized to risankizumab who achieved an sPGA score of 0/1 were rerandomized 1:2 to risankizumab or placebo every 12 weeks (part B).
Main Outcomes and Measures


Co-primary end points for the part A1 phase included proportions of patients achieving greater than or equal to 90% improvement in PASI (PASI 90) and sPGA score of 0/1 at week 16. The PASI measures severity of erythema, infiltration, and desquamation weighted by area of skin involvement over the head, trunk, upper extremities, and lower extremities; scores range from 0 (no disease) to 72 (maximal disease activity). The sPGA assesses average thickness, erythema, and scaling of all psoriatic lesions; scores range from 0 (clear) to 4 (severe), with 0/1 indicating clear or almost clear. Primary and secondary end points in part B included proportion of rerandomized patients achieving an sPGA score of 0/1 at week 52 (primary) and week 104 (secondary).
Results


Of 563 patients screened, 507 were randomized to risankizumab (n = 407) or placebo (n = 100). Most patients were men (356 [70.2%]); median age was 51 years (interquartile range, 38-60 years). At week 16, 298 patients (73.2%) in the treatment group vs 2 patients (2.0%) receiving placebo achieved a PASI 90 response, and 340 patients (83.5%) receiving risankizumab vs 7 patients (7.0%) receiving placebo achieved sPGA 0/1 scores (placebo-adjusted differences: PASI 90: 70.8%; 95% CI, 65.7%-76.0%; sPGA 0/1: 76.5%; 95% CI, 70.4%-82.5%; P < .001 for both). At week 28, 336 responders were rerandomized to risankizumab (n = 111) or treatment withdrawal (n = 225). At week 52, the sPGA 0/1 score was achieved by 97 patients (87.4%) receiving risankizumab vs 138 patients (61.3%) receiving placebo. At week 104, the sPGA 0/1 score was achieved by 90 patients (81.1%) receiving risankizumab vs 16 patients (7.1%) receiving placebo (placebo-adjusted differences: week 52: 25.9%; 95% CI, 17.3%-34.6%; week 104: 73.9%; 95% CI, 66.0%-81.9%; P < .001 for both). Rates of treatment-emergent adverse events were similar between risankizumab (186 [45.7%]) and placebo (49 [49.0%]) in part A1 and remained stable over time.
Conclusions and Relevance


Risankizumab showed superior efficacy compared with placebo through 16 weeks and treatment withdrawal through 2 years. Risankizumab was well tolerated, with no unexpected safety findings during the 2-year trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT02672852.",2020,"Rates of treatment-emergent adverse events were similar between risankizumab (186 [45.7%]) and placebo (49 [49.0%]) in part A1 and remained stable over time.
","['Patients With Moderate to Severe Plaque Psoriasis', 'Most patients were men (356 [70.2%]); median age was 51 years (interquartile range, 38-60 years', 'adults with moderate to severe plaque psoriasis', ""507 eligible patients had stable moderate to severe chronic plaque psoriasis for 6 months or longer, body surface area involvement greater than or equal to 10%, Psoriasis Area and Severity Index (PASI) greater than or equal to 12, and a static Physician's Global Assessment (sPGA) score greater than or equal to 3"", '563 patients screened, 507 were randomized to', 'controlled trial conducted from March 6, 2016, to July 26, 2018']","['Risankizumab', 'risankizumab vs placebo', 'risankizumab or placebo', 'placebo', 'placebo (placebo', 'risankizumab', 'Continuous Risankizumab Therapy', 'risankizumab, 150 mg, subcutaneously, or placebo']","['sPGA score', 'sPGA 0/1 score', 'Rates of treatment-emergent adverse events', 'PASI measures severity of erythema, infiltration, and desquamation weighted by area of skin involvement over the head, trunk, upper extremities, and lower extremities; scores range', 'average thickness, erythema, and scaling of all psoriatic lesions; scores range', 'Efficacy and Safety', 'Measures\n\n\nCo-primary end points for the part A1 phase included proportions of patients achieving greater than or equal to 90% improvement in PASI (PASI 90) and sPGA score', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439091', 'cui_str': '>='}]",507.0,0.491652,"Rates of treatment-emergent adverse events were similar between risankizumab (186 [45.7%]) and placebo (49 [49.0%]) in part A1 and remained stable over time.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Leonardi', 'Affiliation': 'Department of Dermatology, St Louis University, St Louis, Missouri.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""Division of Dermatology, Department of Medicine, School of Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Philipp', 'Affiliation': 'Department of Dermatology and Allergy/Institute of Medical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jashin J', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Dermatology Research and Education Foundation, Irvine, California.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center, Tokyo, Japan.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Flack', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut.'}, {'ForeName': 'Ziqian', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Tianshuang', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Camez', 'Affiliation': 'AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.0723']
229,31557585,"Return to work after surgery for lumbar disc herniation, secondary analyses from a randomized controlled trial comparing supervised rehabilitation versus home exercises.","BACKGROUND CONTEXT


Patients undergoing lumbar discectomy are typically referred for postoperative rehabilitation. However, evidence regarding effectiveness of postoperative rehabilitation to improve surgical outcome and hasten return to work is scarce with conflicting results in the published literature.
PURPOSE


This study investigates the effect of postoperative rehabilitation on return to work, duration of sick leave and working ability after surgery for lumbar disc herniation.
STUDY DESIGN/SETTING


Single center randomized controlled trial.
PATIENT SAMPLE


Patients scheduled for primary discectomy due to lumbar disc herniation were included in the study.
OUTCOME MEASURES


Self-reported measures included working ability, work status, and job type defined by the International Standard Classification of Occupations. All outcomes including duration of sick leave were obtained from follow-up questionnaires at 1 and 2 years after surgery.
METHODS


This is a secondary analysis from a randomized controlled trial comparing patients who were referred to rehabilitation at the municipal facility starting 4-6 weeks postoperative (REHAB) and patients sent home after surgery without any planned rehabilitation course (HOME). Linear regression was performed to identify baseline characteristics associated with duration of sick leave.
RESULTS


One hundred forty-six patients were included and equally distributed between the groups. Follow-up rate was 78% after 1 and 2 years. Both groups had a similar postoperative sick leave period of approximately 9 weeks. After 1 year 79% had returned to work in the HOME-group versus 74% in the REHAB-group, which was not statistically significant. Working ability improved from baseline to 1 year in both groups and this improvement was sustained at 2-year follow-up. Stepwise linear regression showed that preoperative duration of leg pain and working ability was associated with duration of postoperative sick leave.
CONCLUSIONS


Referral for unstandardized municipal rehabilitation does not affect duration of postoperative sick leave, return to work or working ability in patients recovering after surgery for lumbar disc herniation. Duration of preoperative leg pain and preoperative working ability was significantly associated with the duration of postoperative sick leave.",2020,Working ability improved from baseline to one year in both groups and this improvement was sustained at two-year follow-up.,"['patients recovering after surgery for lumbar disc herniation', 'patients who were referred to rehabilitation at the municipal facility starting 4-6 weeks postoperative (REHAB) and patients sent home after surgery without any planned rehabilitation course (HOME', 'SAMPLE\n\n\nPatients scheduled for primary discectomy due to lumbar disc herniation were included in the study', 'One hundred forty-six patients were included and equally distributed between the groups']","['supervised rehabilitation versus home exercises', 'postoperative rehabilitation']","['Working ability', 'preoperative duration of leg pain and working ability', 'duration of sick leave', 'working ability, work status and job type defined by the International Standard Classification of Occupations', 'Duration of preoperative leg pain and preoperative working ability', 'return to work, duration of sick leave and working ability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0206078', 'cui_str': 'Diskectomy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}]",146.0,0.118255,Working ability improved from baseline to one year in both groups and this improvement was sustained at two-year follow-up.,"[{'ForeName': 'Rune Tendal', 'Initials': 'RT', 'LastName': 'Paulsen', 'Affiliation': 'Center for Spine Surgery and Research, Spine Center of Southern Denmark, Lillebaelt Hospital, Middelfart, Denmark. Electronic address: rune.tendal.paulsen@rsyd.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Occupational Medicine, Hospital of South West Jutland, Esbjerg, Denmark.'}, {'ForeName': 'Leah Y', 'Initials': 'LY', 'LastName': 'Carreon', 'Affiliation': 'Center for Spine Surgery and Research, Spine Center of Southern Denmark, Lillebaelt Hospital, Middelfart, Denmark.'}, {'ForeName': 'Mikkel Østerheden', 'Initials': 'MØ', 'LastName': 'Andersen', 'Affiliation': 'Center for Spine Surgery and Research, Spine Center of Southern Denmark, Lillebaelt Hospital, Middelfart, Denmark.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2019.09.019']
230,32077907,Assessment of the DRCR Retina Network Approach to Management With Initial Observation for Eyes With Center-Involved Diabetic Macular Edema and Good Visual Acuity: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Among eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity (VA), randomized clinical trial results showed no difference in VA loss between initial observation plus aflibercept only if VA decreased, initial focal/grid laser plus aflibercept only if VA decreased, or prompt aflibercept. Understanding the initial observation approach is relevant to patient management.
Objective


To assess the DRCR Retina Network protocol-defined approach and outcomes of initial observation with aflibercept only if VA worsened.
Design, Setting, and Participants


This was a post hoc secondary analyses of a randomized clinical trial of the DRCR Retina Network Protocol V that included 91 US and Canadian sites from November 2013 to September 2018. Participants were adults (n = 236) with type 1 or 2 diabetes, 1 study eye with CI-DME, and VA letter score at least 79 (Snellen equivalent, 20/25 or better) assigned to initial observation. Data were analyzed from March 2019 to November 2019.
Interventions


Initial observation and follow-up with aflibercept only for VA loss of at least 10 letters from baseline at 1 visit or 5 to 9 letters at 2 consecutive visits. Follow-up occurred at 8 weeks and then every 16 weeks unless VA or optical coherence tomography central subfield thickness worsened.
Main Outcomes and Measures


Whether individuals received aflibercept.
Results


Among 236 eyes in 236 individuals (149 [63%] male; median age, 60 years [interquartile range, 53-67 years]) randomly assigned to initial observation, 80 (34%) were treated with aflibercept during 2 years of follow-up. At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]). Receipt of aflibercept was more likely in eyes with baseline central subfield thickness at least 300 μm (Zeiss-Stratus equivalent) vs less than 300 μm (45% vs 26%; hazard ratio [HR], 1.98 [95% CI, 1.26-3.13], continuous P = .005), moderately severe nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study retinopathy severity level 47) and above vs moderate nonproliferative diabetic retinopathy (retinopathy severity level 43) and below (51% vs 27%; HR, 2.22 [95% CI, 1.42-3.47], ordinal P < .001), and among participants whose nonstudy eye received DME treatment within 4 months of randomization vs not (52% vs 25%; HR, 2.55 [95% CI, 1.64-3.99], P < .001).
Conclusions and Relevance


Most eyes managed with initial observation plus aflibercept only if VA worsened maintained good vision at 2 years and did not require aflibercept for VA loss. However, the eyes in the trial were approximately twice as likely to receive aflibercept for VA loss if they had greater baseline central subfield thickness, worse diabetic retinopathy severity level, or a nonstudy eye receiving treatment for DME.
Trial Registration


ClinicalTrials.gov Identifier: NCT01909791.",2020,"At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]).","['eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity (VA', '236 eyes in 236 individuals (149 [63%] male; median age, 60 years [interquartile range, 53-67 years]) randomly assigned to initial observation, 80 (34%) were treated with', 'that included 91 US and Canadian sites from November 2013 to September 2018', 'Eyes', 'Participants were adults (n\u2009=\u2009236) with type 1 or 2 diabetes, 1 study eye with CI-DME, and VA letter score at least 79 (Snellen equivalent, 20/25 or better) assigned to initial observation']","['aflibercept', 'DRCR Retina Network Protocol V']","['VA loss', 'diabetic retinopathy severity level', 'moderately severe nonproliferative diabetic retinopathy', 'median VA letter score', 'nonproliferative diabetic retinopathy', 'Diabetic Macular Edema and Good Visual Acuity']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1690939', 'cui_str': '6/7.5'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0035298', 'cui_str': 'Retina'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0730278', 'cui_str': 'Severe nonproliferative retinopathy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004606', 'cui_str': 'NPDR - Non proliferative diabetic retinopathy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",,0.325444,"At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]).","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Omar S', 'Initials': 'OS', 'LastName': 'Punjabi', 'Affiliation': 'Charlotte Eye, Ear, Nose, and Throat Associates PA, Charlotte, North Carolina.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston, Texas.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.6035']
231,31494376,Randomized controlled trial of adjunctive Valproate for cognitive remediation in early course schizophrenia.,"BACKGROUND


Schizophrenia (SZ) is associated with cognitive impairment that contributes to disability, but the cognitive dysfunction is relatively refractory to pharmacologic intervention. Though Valproate augmentation is reported to improve psychopathology among patients with SZ, its effects on cognitive functions have not been investigated systematically.
METHODS


Using a randomized double blind placebo controlled design, the effects of Valproate or placebo as adjuncts to risperidone (RISP) treatment were evaluated among patients with early course SZ (N = 109). Domains of cognitive function, estimated using the Arabic version of the Penn Computerized Neurocognitive Battery, were the prime outcomes. Clinical severity and social function were secondary outcomes. We also explored the effects of valproate treatment on serological responses to Toxoplama Gondii (TOXO), a putative risk factor for cognitive dysfunction in SZ.
RESULTS


There were no significant differences between Valproate and placebo (PLA) treated groups with respect to changes in cognitive functions, positive or negative symptom scores or daily function scores at the beginning and end of the study. No significant Valproate/PLA differences were noted on TOXO serostatus or TOXO-related cognitive dysfunction.
CONCLUSION


Valproate treatment may not be beneficial for cognitive dysfunction in SZ or for TOXO infection.",2019,"There were no significant differences between Valproate and placebo (PLA) treated groups with respect to changes in cognitive functions, positive or negative symptom scores or daily function scores at the beginning and end of the study.","['patients with early course SZ (N\u202f=\u202f109', 'patients with SZ', 'early course schizophrenia']","['Valproate', 'placebo', 'valproate', 'risperidone (RISP', 'adjunctive Valproate', 'Valproate and placebo (PLA', 'Valproate or placebo']","['Clinical severity and social function', 'cognitive functions, positive or negative symptom scores or daily function scores', 'TOXO serostatus or TOXO-related cognitive dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.203215,"There were no significant differences between Valproate and placebo (PLA) treated groups with respect to changes in cognitive functions, positive or negative symptom scores or daily function scores at the beginning and end of the study.","[{'ForeName': 'Ibtihal', 'Initials': 'I', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Salwa', 'Initials': 'S', 'LastName': 'Tobar', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Warda', 'Initials': 'W', 'LastName': 'Fathi', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'ElSayed', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Yassein', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Eissa', 'Affiliation': 'Department of Psychiatry, Port-said University School of Medicine, Port-said, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Elsheshtawy', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Elboraei', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shahda', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Elwasify', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Clinical pathology department, Mansoura university student Hospital, Egypt.'}, {'ForeName': 'Kehui', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Dickerson', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, MD, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Yolken', 'Affiliation': 'Stanley Division of Developmental Neurovirology, Department of Pediatrics, USA.'}, {'ForeName': 'Farha', 'Initials': 'F', 'LastName': 'El Chennawi', 'Affiliation': 'Department of Clinical Pathology, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Wafaa', 'Initials': 'W', 'LastName': 'El Bahaey', 'Affiliation': 'Department of Psychiatry, Mansoura University School of Medicine, Mansoura, Egypt.'}, {'ForeName': 'Vishwajit', 'Initials': 'V', 'LastName': 'Nimgaonkar', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA; Department of Human Genetics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: nimga+@pitt.edu.'}, {'ForeName': 'Hader', 'Initials': 'H', 'LastName': 'Mansour', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.08.011']
232,31789800,Efficacy of Vestibular Rehabilitation Following Acute Vestibular Neuritis: A Randomized Controlled Trial.,"OBJECTIVE


To investigate whether a vestibular rehabilitation program started early after diagnosis of vestibular neuritis combined with standard care reduces dizziness and improves functions of daily life more effectively than standard care alone in patients with acute vestibular neuritis.
STUDY DESIGN


Non-blinded, randomized controlled trial with 2 parallel groups.
SETTING


Specialist centers in 2 university hospitals.
PATIENTS


Patients, 18-70 years, with acute vestibular neuritis confirmed by videonystagmography.
INTERVENTION


Standard care was 10 days of prednisolone, general information, and counseling given to all patients. In addition to standard care, the intervention group received supervised exercise therapy (vestibular rehabilitation). Vestibular rehabilitation was given in a group format, individually tailored, and supported by home exercises.
MAIN OUTCOME MEASURE


Perceived dizziness during head motion. Secondary outcomes were walking speed, standing balance, Hospital Anxiety and Depression Scale (HADS), Vertigo Symptom Scale, Visual Analog Scales (VASs), Dizziness Handicap Inventory (DHI), The University of California Los Angeles Dizziness Questionnaire.
RESULTS


Sixty-five patients were included, 27 participated in the vestibular rehabilitation group. There was a statistically significant difference in favor of the vestibular rehabilitation group in overall perceived dizziness at 3 (p = 0.007) and 12 months (p = 0.001). No statistically significant differences were found in standing balance and walking speed. Results from self-report measures showed a statistically significant difference at 12 months in HADS (p = 0.039), DHI (p = 0.049) and VAS-C (p = 0.012).
CONCLUSION


A vestibular rehabilitation program started early after confirmed vestibular neuritis diagnosis in addition to standard care reduces the perception of dizziness and improves functions of daily life more effectively than standard care alone.",2020,"Results from self-report measures showed a statistically significant difference at 12 months in HADS (p = 0.039), DHI (p = 0.049) and VAS-C (p = 0.012).
","['patients with acute vestibular neuritis', 'Sixty-five patients were included, 27 participated in the vestibular rehabilitation group', 'Acute Vestibular Neuritis', 'Specialist centers in 2 university hospitals', 'Patients, 18-70 years, with acute vestibular neuritis confirmed by videonystagmography']","['vestibular rehabilitation program', 'Vestibular rehabilitation', 'prednisolone, general information, and counseling given to all patients', 'supervised exercise therapy (vestibular rehabilitation', 'Vestibular Rehabilitation', 'standard care alone']","['DHI', 'dizziness during head motion', 'perception of dizziness', 'HADS', 'standing balance and walking speed', 'walking speed, standing balance, Hospital Anxiety and Depression Scale (HADS), Vertigo Symptom Scale, Visual Analog Scales (VASs), Dizziness Handicap Inventory (DHI), The University of California Los Angeles Dizziness Questionnaire', 'dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0153113', 'cui_str': 'Acute Vestibular Neuritis'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",65.0,0.0925975,"Results from self-report measures showed a statistically significant difference at 12 months in HADS (p = 0.039), DHI (p = 0.049) and VAS-C (p = 0.012).
","[{'ForeName': 'Guri', 'Initials': 'G', 'LastName': 'Tokle', 'Affiliation': 'Clinic of Clinical Service, St. Olavs hospital/Trondheim University Hospital.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Mørkved', 'Affiliation': 'Clinic of Clinical Service, St. Olavs hospital/Trondheim University Hospital.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Bråthen', 'Affiliation': 'Neuroclinic, St. Olavs Hospital/Trondheim University Hospital.'}, {'ForeName': 'Frederik Kragerud', 'Initials': 'FK', 'LastName': 'Goplen', 'Affiliation': 'Department of Otorhinolaryngology & Head and Neck Surgery, Norwegian National Advisory Unit on Vestibular Disorders, Haukeland University Hospital.'}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Faculty of Medicine and Health Sciences.'}, {'ForeName': 'Haakon', 'Initials': 'H', 'LastName': 'Arnesen', 'Affiliation': 'Department of Otorhinolaryngology, St. Olavs Hospital/Trondheim University Hospital.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Holmeslet', 'Affiliation': 'Department of Otorhinolaryngology, St. Olavs Hospital/Trondheim University Hospital.'}, {'ForeName': 'Stein Helge Glad', 'Initials': 'SHG', 'LastName': 'Nordahl', 'Affiliation': 'Department of Otorhinolaryngology & Head and Neck Surgery, Norwegian National Advisory Unit on Vestibular Disorders, Haukeland University Hospital.'}, {'ForeName': 'Kjersti Thulin', 'Initials': 'KT', 'LastName': 'Wilhelmsen', 'Affiliation': 'Department of Health and Function, Western Norway University of Applied Sciences, Bergen, Norway.'}]","Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology",['10.1097/MAO.0000000000002443']
233,31841354,Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial.,"PURPOSE


The phosphatidylinositol 3-kinase (PI3K)/AKT signaling pathway is frequently activated in triple-negative breast cancer (TNBC). The AKT inhibitor capivasertib has shown preclinical activity in TNBC models, and drug sensitivity has been associated with activation of PI3K or AKT and/or deletions of PTEN. The PAKT trial was designed to evaluate the safety and efficacy of adding capivasertib to paclitaxel as first-line therapy for TNBC.
PATIENTS AND METHODS


This double-blind, placebo-controlled, randomized phase II trial recruited women with untreated metastatic TNBC. A total of 140 patients were randomly assigned (1:1) to paclitaxel 90 mg/m 2  (days 1, 8, 15) with either capivasertib (400 mg twice daily) or placebo (days 2-5, 9-12, 16-19) every 28 days until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), PFS and OS in the subgroup with  PIK3CA / AKT1 / PTEN  alterations, tumor response, and safety.
RESULTS


Median PFS was 5.9 months with capivasertib plus paclitaxel and 4.2 months with placebo plus paclitaxel (hazard ratio [HR], 0.74; 95% CI, 0.50 to 1.08; 1-sided  P  = .06 [predefined significance level, 1-sided  P  = .10]). Median OS was 19.1 months with capivasertib plus paclitaxel and 12.6 months with placebo plus paclitaxel (HR, 0.61; 95% CI, 0.37 to 0.99; 2-sided  P  = .04). In patients with  PIK3CA / AKT1 / PTEN -altered tumors (n = 28), median PFS was 9.3 months with capivasertib plus paclitaxel and 3.7 months with placebo plus paclitaxel (HR, 0.30; 95% CI, 0.11 to 0.79; 2-sided  P  = .01). The most common grade ≥ 3 adverse events in those treated with capivasertib plus paclitaxel versus placebo plus paclitaxel, respectively, were diarrhea (13%  v  1%), infection (4%  v  1%), neutropenia (3%  v  3%), rash (4%  v  0%), and fatigue (4%  v  0%).
CONCLUSION


Addition of the AKT inhibitor capivasertib to first-line paclitaxel therapy for TNBC resulted in significantly longer PFS and OS. Benefits were more pronounced in patients with  PIK3CA / AKT1 / PTEN -altered tumors. Capivasertib warrants further investigation for treatment of TNBC.",2020,Benefits were more pronounced in patients with  PIK3CA / AKT1 / PTEN,"['women with untreated metastatic TNBC', 'Metastatic Triple-Negative Breast Cancer', 'A total of 140 patients']","['placebo plus paclitaxel', 'capivasertib (400 mg twice daily) or placebo', 'paclitaxel', 'placebo', 'Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel', 'PTEN']","['diarrhea', 'neutropenia', 'fatigue', 'infection', 'median PFS', 'rash', 'safety and efficacy', 'PFS and OS', 'overall survival (OS), PFS and OS in the subgroup with  PIK3CA / AKT1 / PTEN  alterations, tumor response, and safety', 'Median OS', 'progression-free survival (PFS', 'Median PFS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",140.0,0.27384,Benefits were more pronounced in patients with  PIK3CA / AKT1 / PTEN,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Jacinta', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Velindre National Health Service (NHS) Trust, Cardiff, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Wheatley', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom.'}, {'ForeName': 'Adrian Murray', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Nemsadze', 'Affiliation': 'Institute of Clinical Oncology, Tbilisi, Georgia.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Baird', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Centre, Seoul, Republic of Korea.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hall', 'Affiliation': 'Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stein', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, University College London, London, United Kingdom.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Mangel', 'Affiliation': 'Institute of Oncology, Medical University of Pécs, Pecs, Hungary.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Barts Hospital NHS Trust, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conibear', 'Affiliation': 'Barts Hospital NHS Trust, London, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Elza C', 'Initials': 'EC', 'LastName': 'de Bruin', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McEwen', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stetson', 'Affiliation': 'AstraZeneca, Waltham, MA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dougherty', 'Affiliation': 'AstraZeneca, Waltham, MA.'}, {'ForeName': 'Shah-Jalal', 'Initials': 'SJ', 'LastName': 'Sarker', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'McLaughlin-Callan', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burgess', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Cartwright', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mousa', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00368']
234,32285126,Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study.,"This phase 2 study was designed to compare systemic decitabine exposure, demethylation activity, and safety in the first 2 cycles with cedazuridine 100 mg/decitabine 35 mg vs standard decitabine 20 mg/m2 IV. Adults with International Prognostic Scoring System intermediate-1/2- or high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) were randomized 1:1 to receive oral cedazuridine/decitabine or IV decitabine in cycle 1, followed by crossover to the other treatment in cycle 2. All patients received oral cedazuridine/decitabine in subsequent cycles. Cedazuridine and decitabine were given initially as separate capsules in a dose-confirmation stage and then as a single fixed-dose combination (FDC) tablet. Primary end points: mean decitabine systemic exposure (geometric least-squares mean [LSM]) of oral/IV 5-day area under curve from time 0 to last measurable concentration (AUClast), percentage long interspersed nuclear element 1 (LINE-1) DNA demethylation for oral cedazuridine/decitabine vs IV decitabine, and clinical response. Eighty patients were randomized and treated. Oral/IV ratios of geometric LSM 5-day AUClast (80% confidence interval) were 93.5% (82.1-106.5) and 97.6% (80.5-118.3) for the dose-confirmation and FDC stages, respectively. Differences in mean %LINE-1 demethylation between oral and IV were ≤1%. Clinical responses were observed in 48 patients (60%), including 17 (21%) with complete response. The most common grade ≥3 adverse events regardless of causality were neutropenia (46%), thrombocytopenia (38%), and febrile neutropenia (29%). Oral cedazuridine/decitabine (100/35 mg) produced similar systemic decitabine exposure, DNA demethylation, and safety vs decitabine 20 mg/m2 IV in the first 2 cycles, with similar efficacy. This study is registered at www.clinicaltrials.gov as #NCT02103478.",2020,"Oral/IV ratios of geometric LSM 5-day AUClast (80% confidence interval) were 93.5% (82.1%, 106.5%) and 97.6% (80.5%, 118.3%) for the dose-confirmation and FDC stages, respectively.","['Eighty patients', 'Adults with International Prognostic Scoring System intermediate-1/2- or high-risk myelodysplastic syndromes (MDS), or chronic myelomonocytic leukemia (CMML']","['oral cedazuridine/decitabine', 'Cedazuridine and decitabine', 'cedazuridine 100 mg/decitabine 35 mg vs standard decitabine 20 mg', 'oral cedazuridine/decitabine or IV decitabine', 'Oral cedazuridine/decitabine', 'decitabine']","['febrile neutropenia', 'mean decitabine systemic exposure (geometric least-squares mean [LSM]) of oral/IV 5-day area under curve from time 0 to last measurable concentration (AUClast), % long interspersed nuclear element 1 (LINE-1) DNA demethylation for oral cedazuridine/decitabine vs IV decitabine, and clinical response', 'systemic decitabine exposure, DNA demethylation, and safety', 'systemic decitabine exposure, demethylation activity, and safety', 'geometric LSM 5-day AUClast', 'neutropenia', 'Clinical responses', 'thrombocytopenia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0023480', 'cui_str': 'Chronic myelomonocytic leukemia'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C2755352', 'cui_str': 'DNA Demethylation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0598864', 'cui_str': 'Demethylation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}]",80.0,0.0957721,"Oral/IV ratios of geometric LSM 5-day AUClast (80% confidence interval) were 93.5% (82.1%, 106.5%) and 97.6% (80.5%, 118.3%) for the dose-confirmation and FDC stages, respectively.","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Griffiths', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Steensma', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Gail J', 'Initials': 'GJ', 'LastName': 'Roboz', 'Affiliation': 'Weill Cornell Medicine, New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCloskey', 'Affiliation': 'Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Olatoyosi', 'Initials': 'O', 'LastName': 'Odenike', 'Affiliation': 'The University of Chicago Pritzker School of Medicine, Chicago, IL.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'DeZern', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yee', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Busque', 'Affiliation': 'Hôpital Maisonneuve-Rosemont, Montréal, QC, Canada.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': ""O'Connell"", 'Affiliation': 'USC Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Michaelis', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Brandwein', 'Affiliation': 'University of Alberta Hospital, Edmonton, AB, Canada.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Oganesian', 'Affiliation': 'Astex Pharmaceuticals, Inc., Pleasanton, CA; and.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azab', 'Affiliation': 'Astex Pharmaceuticals, Inc., Pleasanton, CA; and.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN.'}]",Blood,['10.1182/blood.2019004143']
235,32285195,The Utility of Diaphragm Ultrasound in Reducing Time to Extubation.,"PURPOSE


Prediction of optimal timing for extubation of mechanically ventilated patients is challenging. Ultrasound measures of diaphragm thickness or diaphragm dome excursion have been used to aid in predicting extubation success or failure. The aim of this study was to determine if incorporating results of diaphragm ultrasound into usual ICU care would shorten the time to extubation.
METHODS


We performed a prospective, randomized, controlled study at three Brown University teaching hospitals. Included subjects underwent block randomization to either usual care (Control) or usual care enhanced with ultrasound measurements of the diaphragm (Intervention). The primary outcome was the time to extubation after ultrasound, and the secondary outcome was the total days on the ventilator. Only intensivists in the Intervention group would have the ultrasound information on the likelihood of successful extubation available to incorporate with traditional clinical and physiologic measures to determine the timing of extubation.
RESULTS


A total of 32 subjects were studied; 15 were randomized into the Control group and 17 into the Intervention group. The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04). The time from ultrasound to extubation was shorter in subjects with a normally functioning diaphragm (∆tdi% ≥ 30%) compared to those with diaphragm dysfunction (∆tdi% < 30%) (23.2 ± 35.2 vs 57.3 ± 52.0 h p = 0.046). When combining the Intervention and Control groups, a value of ∆tdi% ≥ 30% for extubation success at 24 h provided a sensitivity, specificity, PPV and NPV of 90.9%, 86.7%, 90.9%, and 86.7%, respectively.
CONCLUSIONS


Diaphragm ultrasound evaluation of ∆tdi% aids in reducing time to extubation.",2020,"The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04).","['three Brown University teaching hospitals', 'mechanically ventilated patients', 'A total of 32 subjects were studied; 15']","['Diaphragm Ultrasound', 'diaphragm ultrasound into usual ICU care', 'usual care (Control) or usual care enhanced with ultrasound measurements of the diaphragm (Intervention']","['time to extubation', 'sensitivity, specificity, PPV and NPV', 'total days on the ventilator', 'time from ultrasound to extubation', 'time to extubation after ultrasound']","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0028586', 'cui_str': 'Nucleopolyhedrovirus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",32.0,0.0729494,"The time from ultrasound to extubation was significantly reduced in the Intervention group compared to the Control group in patients with a ∆tdi% ≥ 30% (4.8 ± 8.4 vs 35.0 ± 41.0 h, p = 0.04).","[{'ForeName': 'F Dennis', 'Initials': 'FD', 'LastName': 'McCool', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Dennis O', 'Initials': 'DO', 'LastName': ""Oyieng'o"", 'Affiliation': ', 3311 E Murdock St 3rd floor, Wichita, KS, 67208, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Koo', 'Affiliation': 'University of Tennessee College of Medicine Chattanooga, Baroness Erlanger Hospital, 975 E 3rd Street, C-735, Chattanooga, TN, 37403, USA. drpkoo@gmail.com.'}]",Lung,['10.1007/s00408-020-00352-3']
236,32280080,Effects of nimodipine combined with betahistine on CRP and other inflammatory cytokines and vascular endothelial function in patients with hypertensive cerebral vasospasm.,"OBJECTIVE


This study aims to investigate the effect of nimodipine combined with betahistine on the levels of CRP and other inflammatory cytokines, as well as vascular endothelial function in patients with hypertensive cerebral vasospasm.
METHODS


A total of 80 patients with hypertensive cerebral vasospasm from March 2016 to September 2018 were enrolled and randomly equally divided into two groups. At 1 week before enrollment, the application of all antihypertensive drugs was stopped. Then amlodipine tablets were used in control group, based on which nimodipine tablets were applied in observation group. All the patients included were followed up for 1 month. The changes in the cerebral vasospasm index in the course of treatment as well as inflammatory cytokines and indicators related to vascular endothelial function at 1 month after treatment were measured and compared between the two groups. The correlations of the cerebral vasospasm index with the changes in inflammatory cytokines and vascular endothelial function-related factors in the body were analyzed. Finally, the effective rates of blood pressure regulation and cerebral vasospasm treatment were compared, while the adverse reactions and the overall clinical treatment effect of the two groups were evaluated.
RESULTS


The cerebral vasospasm indexes in observation group were significantly lower than those in control group at 3 d, 1 week and 1 month after treatment (p < 0.05). At 1 month after treatment, the levels of inflammatory cytokines such as high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) in observation group were significantly reduced compared to those in control group (p < 0.05). As for vascular endothelial function-related indicators, the endothelin-1 (ET-1) level in observation group was markedly lower than that in control group, whereas the level of nitric oxide (NO) was statistically higher than that in control group (p < 0.05). The cerebral vasospasm index was statistically positively correlated with changes in hs-CRP, IL-6, TNF-α and ET-1 (p < 0.05), but negatively correlated with changes in NO (p < 0.05). Besides, the effective rates of blood pressure regulation and cerebral vasospasm treatment in observation group were significantly higher than those in control group (p < 0.05). The overall treatment effective rate in observation group was markedly higher than that in control group (p < 0.05), and there were no significant differences of adverse reactions between the two groups (p > 0.05).
CONCLUSION


For the treatment of hypertensive cerebral vasospasm, combined application of betahistine on the basis of nimodipine can effectively reduce the body's aseptic inflammatory responses, improve vascular endothelial function and increase the cerebral circulation blood flow, which offers a favorable strategy for clinical therapy.",2020,"The overall treatment effective rate in observation group was markedly higher than that in control group (p < 0.05), and there were no significant differences of adverse reactions between the two groups (p > 0.05).
","['80 patients with hypertensive cerebral vasospasm from March 2016 to September 2018', 'patients with hypertensive cerebral vasospasm']","['nimodipine', 'nimodipine combined with betahistine', 'betahistine', 'nimodipine tablets', 'amlodipine']","['effective rates of blood pressure regulation and cerebral vasospasm treatment', 'overall treatment effective rate', 'levels of inflammatory cytokines such as high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α', 'vascular endothelial function', 'cerebral vasospasm indexes', 'cerebral circulation blood flow', 'cerebral vasospasm index', 'CRP and other inflammatory cytokines and vascular endothelial function', 'adverse reactions', 'hs-CRP, IL-6, TNF-α and ET-1', 'vascular endothelial function-related indicators, the endothelin-1 (ET-1) level', 'level of nitric oxide (NO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0005301', 'cui_str': 'BETAHISTINE'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0265110', 'cui_str': 'Spasm of cerebral arteries'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",80.0,0.0301013,"The overall treatment effective rate in observation group was markedly higher than that in control group (p < 0.05), and there were no significant differences of adverse reactions between the two groups (p > 0.05).
","[{'ForeName': 'Xuanwei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Rehabilitation, ShenZhen DaPeng New District NanAo People's Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': ""Na'na"", 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Massage, Shenzhen Luohu District Hospital of Chinese Medicine, Shenzhen, Guangdong, China.'}, {'ForeName': 'Kexue', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Department of Acupuncture and Massage, GuangDong Province Second Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xiao', 'Affiliation': ""Department of Rehabilitation, ShenZhen DaPeng New District NanAo People's Hospital, Shenzhen, Guangdong, China.""}, {'ForeName': 'Pengjie', 'Initials': 'P', 'LastName': 'Sheng', 'Affiliation': 'Department of Acupuncture and Massage, Shenzhen Luohu District Hospital of Chinese Medicine, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Rehabilitation, Shenzhen Sanming Group, Kerry Rehabilitation Medicine Research, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, The First Affiliated Hospital, Shenzhen University, Shenzhen, Guangdong, China.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190589']
237,32280083,Erythrocyte deformability and aggregation in morbidly obese women undergoing laparoscopic gastric bypass surgery and effects of oral omega-3 fatty acid supplementation.,"BACKGROUND


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


To investigate peri-operative erythrocyte function and effects of oral omega-3 fatty acids in morbidly obese women undergoing gastric bypass surgeryMETHODS:Fifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery were randomized between a low calorie diet (LCD) during 2 weeks or oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs) and a normal diet during 4 weeks. Peri-operative blood samples were analyzed with the Lorrca MaxSIS Ektacytometer for erythrocyte deformability and aggregability.
RESULTS


There were no significant differences in erythrocyte function between the groups at any time point. Only erythrocyte aggregability parameters were affected by surgery. At six month follow-up, aggregation index (AI) and cholesterol, glucose and insulin were significantly improved.
CONCLUSIONS


In this study, oral Omega-3 supplementation did not affect erythrocyte function compared to a LCD. Six months after surgery a significant improvement in AI and metabolic parameters was observed in both groups, contributing to a reduction in the risk at thromboembolic and cardiovascular complications.",2020,There were no significant differences in erythrocyte function between the groups at any time point.,"['morbidly obese women undergoing gastric bypass surgeryMETHODS:Fifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery', 'morbidly obese women undergoing']","['oral omega-3 fatty acids', 'oral Omega-3 supplementation', 'oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs', 'laparoscopic gastric bypass surgery', 'low calorie diet (LCD', 'oral omega-3 fatty acid supplementation']","['erythrocyte aggregability parameters', 'erythrocyte function', 'Erythrocyte deformability and aggregation', 'AI and metabolic parameters', 'risk at thromboembolic and cardiovascular complications', 'aggregation index (AI) and cholesterol, glucose and insulin']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C4039248', 'cui_str': 'Laparoscopic bypass of stomach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0014774', 'cui_str': 'Erythrocyte deformability'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",,0.0237369,There were no significant differences in erythrocyte function between the groups at any time point.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bakker', 'Affiliation': 'Northwest Clinics Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Northwest Clinics Alkmaar, Alkmaar, The Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Demirkiran', 'Affiliation': 'Red Cross Hospital Beverwijk, Beverwijk, The Netherlands.'}, {'ForeName': 'Huib A', 'Initials': 'HA', 'LastName': 'Cense', 'Affiliation': 'Red Cross Hospital Beverwijk, Beverwijk, The Netherlands.'}, {'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Houdijk', 'Affiliation': 'Northwest Clinics Alkmaar, Alkmaar, The Netherlands.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190777']
238,31446218,"Treatment for Gulf War Illness (GWI) with KPAX002 (methylphenidate hydrochloride + GWI nutrient formula) in subjects meeting the Kansas case definition: A prospective, open-label trial.","This study tested the safety, tolerability, and efficacy of KPAX002-a combination of methylphenidate hydrochloride plus a micronutrient formula designed to support mitochondrial function-as a treatment for Gulf War Illness (GWI). This open-label trial enrolled 17 subjects meeting the Kansas case definition for GWI. Of the 17 subjects enrolled, 15 qualified for the Intent-to-Treat (ITT) population with 10 subjects completing the trial per protocol. All analyses were on the ITT population. At 12 weeks, subjects taking KPAX002 experienced a mean 25% reduction in their overall GWI symptoms severity as measured by the GWI Symptoms Assessment Tool (SAT) (p < 0.001). Visual analog scale scores were also significantly reduced for fatigue (p = 0.019), cognitive symptoms (p = 0.006), sleep problems (p = 0.026), and pain (p = 0.05). Twelve weeks of KPAX002 administration resulted in a significant improvement in GWI symptoms with an acceptable side effect profile. A larger randomized, double-blinded, placebo-controlled trial is necessary to determine if the observed benefit can be replicated.",2019,"Visual analog scale scores were also significantly reduced for fatigue (p = 0.019), cognitive symptoms (p = 0.006), sleep problems (p = 0.026), and pain (p = 0.05).","['Gulf War Illness (GWI', 'subjects meeting the Kansas case definition', '17 subjects enrolled, 15 qualified for the Intent-to-Treat (ITT) population with 10 subjects completing the trial per protocol', '17 subjects meeting the Kansas case definition for GWI']","['placebo', 'KPAX002 (methylphenidate hydrochloride + GWI nutrient formula', 'KPAX002-a combination of methylphenidate hydrochloride', 'KPAX002']","['fatigue', 'safety, tolerability, and efficacy', 'GWI symptoms', 'pain', 'sleep problems', 'cognitive symptoms', 'Visual analog scale scores', 'overall GWI symptoms severity', 'GWI Symptoms Assessment Tool (SAT']","[{'cui': 'C1449761', 'cui_str': 'Gulf War'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700545', 'cui_str': 'Methylphenidate Hydrochloride'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]",17.0,0.135117,"Visual analog scale scores were also significantly reduced for fatigue (p = 0.019), cognitive symptoms (p = 0.006), sleep problems (p = 0.026), and pain (p = 0.05).","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holodniy', 'Affiliation': 'Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA; Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Kaiser', 'Affiliation': 'K-PAX Pharmaceuticals, Inc, Mill Valley, CA, USA; University of California San Francisco Medical School, San Francisco, CA, USA. Electronic address: j.kaiser@kpaxpharm.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.08.003']
239,31697365,Communication With Older Patients With Cancer Using Geriatric Assessment: A Cluster-Randomized Clinical Trial From the National Cancer Institute Community Oncology Research Program.,"Importance


Older patients with cancer and their caregivers worry about the effects of cancer treatment on aging-related domains (eg, function and cognition). Quality conversations with oncologists about aging-related concerns could improve patient-centered outcomes. A geriatric assessment (GA) can capture evidence-based aging-related conditions associated with poor clinical outcomes (eg, toxic effects) for older patients with cancer.
Objective


To determine whether providing a GA summary and GA-guided recommendations to oncologists can improve communication about aging-related concerns.
Design, Setting, and Participants


This cluster-randomized clinical trial enrolled 541 participants from 31 community oncology practices within the University of Rochester National Cancer Institute Community Oncology Research Program from October 29, 2014, to April 28, 2017. Patients were aged 70 years or older with an advanced solid malignant tumor or lymphoma who had at least 1 impaired GA domain; patients chose 1 caregiver to participate. The primary outcome was assessed on an intent-to-treat basis.
Interventions


Oncology practices were randomized to receive either a tailored GA summary with recommendations for each enrolled patient (intervention) or alerts only for patients meeting criteria for depression or cognitive impairment (usual care).
Main Outcomes and Measures


The predetermined primary outcome was patient satisfaction with communication about aging-related concerns (modified Health Care Climate Questionnaire [score range, 0-28; higher scores indicate greater satisfaction]), measured after the first oncology visit after the GA. Secondary outcomes included the number of aging-related concerns discussed during the visit (from content analysis of audiorecordings), quality of life (measured with the Functional Assessment of Cancer Therapy scale for patients and the 12-Item Short Form Health Survey for caregivers), and caregiver satisfaction with communication about aging-related patient concerns.
Results


A total of 541 eligible patients (264 women, 276 men, and 1 patient did not provide data; mean [SD] age, 76.6 [5.2] years) and 414 caregivers (310 women, 101 men, and 3 caregivers did not provide data; mean age, 66.5 [12.5] years) were enrolled. Patients in the intervention group were more satisfied after the visit with communication about aging-related concerns (difference in mean score, 1.09 points; 95% CI, 0.05-2.13 points; P = .04); satisfaction with communication about aging-related concerns remained higher in the intervention group over 6 months (difference in mean score, 1.10; 95% CI, 0.04-2.16; P = .04). There were more aging-related conversations in the intervention group's visits (difference, 3.59; 95% CI, 2.22-4.95; P < .001). Caregivers in the intervention group were more satisfied with communication after the visit (difference, 1.05; 95% CI, 0.12-1.98; P = .03). Quality of life outcomes did not differ between groups.
Conclusions and Relevance


Including GA in oncology clinical visits for older adults with advanced cancer improves patient-centered and caregiver-centered communication about aging-related concerns.
Trial Registration


ClinicalTrials.gov identifier: NCT02107443.",2020,"Caregivers in the intervention group were more satisfied with communication after the visit (difference, 1.05; 95% CI, 0.12-1.98; P = .03).","['541 eligible patients (264 women, 276 men, and 1 patient did not provide data', 'Older patients with cancer and their caregivers worry', '541 participants from 31 community oncology practices within the University of Rochester National Cancer Institute Community Oncology Research Program from October 29, 2014, to April 28, 2017', 'Patients were aged 70 years or older with an advanced solid malignant tumor or lymphoma who had at least 1 impaired GA domain; patients chose 1 caregiver to participate', 'older patients with cancer', 'Older Patients With Cancer', 'older adults with advanced cancer', 'mean [SD] age, 76.6 [5.2] years) and 414 caregivers (310 women, 101 men, and 3 caregivers did not provide data; mean age, 66.5 [12.5] years) were enrolled']","['tailored GA summary with recommendations for each enrolled patient (intervention) or alerts only for patients meeting criteria for depression or cognitive impairment (usual care', 'GA', 'Geriatric Assessment']","['Quality of life outcomes', 'number of aging-related concerns discussed during the visit (from content analysis of audiorecordings), quality of life (measured with the Functional Assessment of Cancer Therapy scale for patients and the 12-Item Short Form Health Survey for caregivers), and caregiver satisfaction with communication about aging-related patient concerns', 'patient satisfaction with communication about aging-related concerns (modified Health Care Climate Questionnaire [score range, 0-28; higher scores indicate greater satisfaction', 'intent-to-treat basis', 'satisfaction with communication about aging-related concerns']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}]","[{'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0522474', 'cui_str': 'Patient concerned (contextual qualifier) (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}]",541.0,0.154156,"Caregivers in the intervention group were more satisfied with communication after the visit (difference, 1.05; 95% CI, 0.12-1.98; P = .03).","[{'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Epstein', 'Affiliation': 'Department of Family Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Hurria', 'Affiliation': 'Department of Medical Oncology, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Canin', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers University School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Nikesha', 'Initials': 'N', 'LastName': 'Gilmore', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Plumb', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Flannery', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'Department of Medicine, University of Rochester, Rochester, New York.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Kleckner', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'Judith O', 'Initials': 'JO', 'LastName': 'Hopkins', 'Affiliation': 'Novant Health Oncology Specialists, Winston-Salem, North Carolina.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Decatur, Illinois.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Geer', 'Affiliation': 'Metro Minnesota Community Oncology Research Program, St Louis Park.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Gorawara-Bhat', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program Research Base, Rochester, New York.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Dale', 'Affiliation': 'Department of Supportive Care, City of Hope National Medical Center, Duarte, California.'}]",JAMA oncology,['10.1001/jamaoncol.2019.4728']
240,32168197,Attention to breath sensations does not engage endogenous opioids to reduce pain.,"The endogenous opioidergic system is critically involved in the cognitive modulation of pain. Slow-breathing-based techniques are widely used nonpharmacological approaches to reduce pain. Yet, the active mechanisms of actions supporting these practices are poorly characterized. Growing evidence suggest that mindfulness-meditation, a slow-breathing technique practiced by nonreactively attending to breathing sensations, engages multiple unique neural mechanisms that bypass opioidergically mediated descending pathways to reduce pain. However, it is unknown whether endogenous opioids contribute to pain reductions produced by slow breathing. The present double-blind, placebo-controlled crossover study examined behavioral pain responses during mindfulness-meditation (n = 19), sham-mindfulness meditation (n = 20), and slow-paced breathing (n = 20) in response to noxious heat (49°C) and intravenous administration (0.15 mg/kg bolus + 0.1 mg/kg/hour maintenance infusion) of the opioid antagonist, naloxone, and placebo saline. Mindfulness significantly reduced pain unpleasantness ratings across both infusion sessions when compared to rest, but not pain intensity. Slow-paced breathing significantly reduced pain intensity and unpleasantness ratings during naloxone but not saline infusion. Pain reductions produced by mindfulness-meditation and slow-paced breathing were insensitive to naloxone when compared to saline administration. By contrast, sham-mindfulness meditation produced pain unpleasantness reductions during saline infusion but this effect was reversed by opioidergic antagonism. Sham-mindfulness did not lower pain intensity ratings. Self-reported ""focusing on the breath"" was identified as the operational feature particularly unique to the mindfulness-meditation and slow paced-breathing, but not sham-mindfulness meditation. Across all individuals, attending to the breath was associated with naloxone insensitive pain-relief. These findings provide evidence that slow breathing combined with attention to breath reduces pain independent of endogenous opioids.",2020,"Mindfulness significantly reduced pain unpleasantness ratings across both infusion sessions when compared to rest, but not pain intensity.",[],"['naloxone', 'mindfulness-meditation (n=19), sham-mindfulness meditation (n=20), and slow-paced breathing (n=20) in response to noxious heat (49°C) and intravenous administration (0.15 mg/kg bolus + 0.1 mg/kg/h maintenance infusion) of the opioid antagonist, naloxone and placebo-saline', 'Slow-paced breathing', 'placebo']","['pain intensity ratings', 'behavioral pain responses', 'pain unpleasantness ratings', 'pain intensity and unpleasantness ratings', 'Pain reductions', 'pain unpleasantness reductions']",[],"[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0013125'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.112843,"Mindfulness significantly reduced pain unpleasantness ratings across both infusion sessions when compared to rest, but not pain intensity.","[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Wells', 'Affiliation': 'Departments of Neurology and.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Posey', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Afrayem', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Psychiatry, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Auman', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Strittmatter', 'Affiliation': 'School of Pharmacy, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Magalhaes', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Adler-Neal', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'McHaffie', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, CA, United States.'}]",Pain,['10.1097/j.pain.0000000000001865']
241,32144896,A precision medicine approach to develop and internally validate optimal exercise and weight loss treatments for overweight and obese adults with knee osteoarthritis.,"OBJECTIVE


Apply a precision medicine approach to determine the optimal treatment regime for participants in an exercise (E), dietary weight loss (D), and D+E trial for knee osteoarthritis (KOA) that would have maximized their expected outcomes.
METHODS


Using data from 343 participants of the Intensive Diet and Exercise for Arthritis (IDEA) trial, we applied 24 machine-learning models to develop individualized treatment rules on seven outcomes: SF-36 physical component score, weight loss, WOMAC pain/function/stiffness scores, compressive force, and IL-6. The optimal model was selected based on jackknife value function estimates that indicate improvement in the outcome(s) if future participants follow the estimated decision rule compared against the optimal single, fixed treatment model.
RESULTS


Multiple outcome random forest was the optimal model for the WOMAC outcomes. For the other outcomes, list-based models were optimal. For example, the estimated optimal decision rule for weight loss assigned the D+E intervention to participants with baseline weight not exceeding 109.35 kg and waist circumference above 90.25 cm, and assigned D to all other participants except those with history of a heart attack. If applied to future participants, the optimal rule for weight loss is estimated to increase average weight loss to 11.2 kg at 18 months, contrasted with 9.8 kg if all received D+E (p = 0.01).
CONCLUSIONS


The precision medicine models supported the overall findings from IDEA that the D+E intervention was optimal for most participants, but there was evidence that a subgroup of participants would likely benefit more from diet alone for two outcomes.",2020,"If applied to future participants, the optimal rule for weight loss is estimated to increase average weight loss to 11.2 kg at 18 months, contrasted with 9.8 kg if all received D+E (p = 0.01).
","['participants in an exercise (E), dietary weight loss (D), and D+E trial for knee osteoarthritis (KOA', 'Using data from 343 participants of the Intensive Diet and Exercise for Arthritis', 'overweight and obese adults with knee osteoarthritis']",[],"['average weight loss', 'SF-36 physical component score, weight loss, WOMAC pain/function/stiffness scores, compressive force, and IL-6']","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",343.0,0.0379495,"If applied to future participants, the optimal rule for weight loss is estimated to increase average weight loss to 11.2 kg at 18 months, contrasted with 9.8 kg if all received D+E (p = 0.01).
","[{'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Nelson', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Cleveland', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Leigh F', 'Initials': 'LF', 'LastName': 'Callahan', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Loeser', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology and the Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, NC.'}]",Arthritis care & research,['10.1002/acr.24179']
242,32277701,Protective Effectiveness of Long-Lasting Permethrin Impregnated Clothing Against Tick Bites in an Endemic Lyme Disease Setting: A Randomized Control Trial Among Outdoor Workers.,"Tick-borne diseases are a growing threat to public health in the United States, especially among outdoor workers who experience high occupational exposure to ticks. Long-lasting permethrin-impregnated clothing has demonstrated high initial protection against bites from blacklegged ticks, Ixodes scapularis Say (Acari: Ixodidae), in laboratory settings, and sustained protection against bites from the lone star tick, Amblyomma americanum (L.) (Acari: Ixodidae), in field tests. However, long-lasting permethrin impregnation of clothing has not been field tested among outdoor workers who are frequently exposed to blacklegged ticks. We conducted a 2-yr randomized, placebo-controlled, double-blinded trial among 82 outdoor workers in Rhode Island and southern Massachusetts. Participants in the treatment arm wore factory-impregnated permethrin clothing, and the control group wore sham-treated clothing. Outdoor working hours, tick encounters, and bites were recorded weekly to assess protective effectiveness of long-lasting permethrin-impregnated garments. Factory-impregnated clothing significantly reduced tick bites by 65% in the first study year and by 50% in the second year for a 2-yr protective effect of 58%. No significant difference in other tick bite prevention method utilization occurred between treatment and control groups, and no treatment-related adverse outcomes were reported. Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.",2020,Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.,"['Outdoor Workers', '82 outdoor workers in Rhode Island and southern Massachusetts', 'Endemic Lyme Disease Setting']","['factory-impregnated permethrin clothing, and the control group wore sham-treated clothing', 'Factory-impregnated clothing', 'Long-Lasting Permethrin Impregnated Clothing Against Tick Bites', 'placebo']","['Outdoor working hours, tick encounters, and bites', 'tick bites', 'tick bite prevention method utilization']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0024198', 'cui_str': 'Lyme disease'}]","[{'cui': 'C0442614', 'cui_str': 'Factory'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0241407', 'cui_str': 'Tick bite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040203', 'cui_str': 'Ixodida'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0241407', 'cui_str': 'Tick bite'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",82.0,0.0336202,Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.,"[{'ForeName': 'Cedar', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Dyer', 'Affiliation': 'Center for Vector-Borne Disease, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Feng-Chang', 'Initials': 'FC', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bowman', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mather', 'Affiliation': 'Center for Vector-Borne Disease, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Meshnick', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}]",Journal of medical entomology,['10.1093/jme/tjaa061']
243,32276019,Dose reduction using digital fluoroscopy versus digital subtraction angiography in endovascular aneurysm repair: A prospective randomized trial.,"OBJECTIVE


Endovascular aneurysm repair (EVAR) can result in high radiation dose to patients and operators. This prospective randomized study aimed to assess whether patient radiation dose sustained during EVAR could be decreased by predominantly using digital fluoroscopy (DF) vs the standard technique using digital subtraction angiography (DSA).
METHODS


Between February 2011 and June 2017, patients with EVAR of infrarenal abdominal aortic aneurysms were prospectively enrolled and randomly assigned to a standard treatment DSA cohort or a DF cohort in which two or fewer DSA acquisitions were allowed for confirmatory imaging. Primary end points included dose-area product (DAP) and cumulative air kerma. Secondary end points included technical success and conversion to DSA standard treatment (if DF was inadequate for visualization).
RESULTS


For all 43 patients enrolled (26 in the DF cohort, 17 in the DSA cohort), technical success was 100%. Of the 26 DF patients, 5 (19%) required conversion to the DSA cohort. In an intention-to-treat analysis, mean DAP was significantly lower in the DF cohort than in the DSA cohort (132 vs 174 Gy·cm 2 ; P = .04). When patients were separated by number of DSA acquisitions (two or fewer vs three or more), mean DAP decreased 41% (109 vs 185 Gy·cm 2 ; P = .005) and cumulative air kerma decreased 40% (578 vs 964 mGy; P = .004).
CONCLUSIONS


In most patients (81%), DF or limited DSA was adequate for visualization during EVAR. In both intention-to-treat DF and limited-DSA cohorts, mean DAP was significantly decreased. If image quality allows, a DF-only or limited-DSA approach to EVAR decreases radiation dose.",2020,"In an intention-to-treat analysis, mean DAP was significantly lower in the DF cohort than the DSA cohort (132 vs 174 Gy·cm 2 ; P=.04).","['Between February 2011 and June 2017, patients with EVAR of infrarenal abdominal aortic aneurysms', '43 patients enrolled (26 in the DF cohort, 17 in the DSA cohort', 'EVAR']","['Digital Fluoroscopy Versus Digital Subtraction Angiography', 'standard-treatment DSA', 'digital fluoroscopy (DF) versus the standard technique using digital subtraction angiography (DSA', 'EVAR', 'Endovascular aneurysm repair (EVAR']","['dose area product (DAP) and cumulative air kerma (CAK', 'technical success', 'CAK', 'technical success and conversion to DSA standard treatment (if DF was inadequate for visualization', 'mean DAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",43.0,0.184679,"In an intention-to-treat analysis, mean DAP was significantly lower in the DF cohort than the DSA cohort (132 vs 174 Gy·cm 2 ; P=.04).","[{'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Zurcher', 'Affiliation': 'Division of Interventional Radiology, Mayo Clinic Hospital, Phoenix, Ariz.'}, {'ForeName': 'Sailendra G', 'Initials': 'SG', 'LastName': 'Naidu', 'Affiliation': 'Division of Interventional Radiology, Mayo Clinic Hospital, Phoenix, Ariz. Electronic address: naidu.sailen@mayo.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Money', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Mayo Clinic Hospital, Phoenix, Ariz.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Stone', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Mayo Clinic Hospital, Phoenix, Ariz.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Fowl', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Mayo Clinic, Scottsdale, Ariz.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Knuttinen', 'Affiliation': 'Division of Interventional Radiology, Mayo Clinic Hospital, Phoenix, Ariz.'}, {'ForeName': 'Rahmi', 'Initials': 'R', 'LastName': 'Oklu', 'Affiliation': 'Division of Interventional Radiology, Mayo Clinic Hospital, Phoenix, Ariz.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Rotellini Coltvet', 'Affiliation': 'Division of Interventional Radiology, Mayo Clinic Hospital, Phoenix, Ariz.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Crawford', 'Affiliation': 'Department of General Surgery, University of Arizona College of Medicine-Phoenix, Phoenix, Ariz.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Buras', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Scottsdale, Ariz.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Pavlicek', 'Affiliation': 'Department of Radiology, Mayo Clinic, Scottsdale, Ariz.'}]",Journal of vascular surgery,['10.1016/j.jvs.2020.02.050']
244,31591483,Role of appetitive phenotype trajectory groups on child body weight during a family-based treatment for children with overweight or obesity.,"OBJECTIVE


Emerging evidence suggests that individual appetitive traits may usefully explain patterns of weight loss in behavioral weight loss treatments for children. The objective of this study was to identify trajectories of child appetitive traits and the impact on child weight changes over time.
METHODS


Secondary data analyses of a randomized noninferiority trial conducted between 2011 and 2015 evaluated children's appetitive traits and weight loss. Children with overweight and obesity (mean age = 10.4; mean BMI z = 2.0; 67% girls; 32% Hispanic) and their parent (mean age = 42.9; mean BMI = 31.9; 87% women; 31% Hispanic) participated in weight loss programs and completed assessments at baseline, 3, 6,12, and 24 months. Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories. Linear mixed-effects models were used to identify the impact of group trajectory on child BMIz change over time.
RESULTS


One hundred fifty children and their parent enrolled in the study. The three-group trajectory model was the most parsimonious and included a high satiety responsive group (HighSR; 47.4%), a high food responsive group (HighFR; 34.6%), and a high emotional eating group (HighEE; 18.0%). Children in all trajectories lost weight at approximately the same rate during treatment, however, only the HighSR group maintained their weight loss during follow-ups, while the HighFR and HighEE groups regained weight (adjusted p-value < 0.05).
CONCLUSIONS


Distinct trajectories of child appetitive traits were associated with differential weight loss maintenance. Identified high-risk subgroups may suggest opportunities for targeted intervention and maintenance programs.",2019,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","['children', 'children with overweight or obesity', 'Children with overweight and obesity (mean age\u2009', 'One hundred fifty children and their parent enrolled in the study', ""2011 and 2015 evaluated children's appetitive traits and weight loss""]",['appetitive phenotype trajectory'],"['child body weight', 'differential weight loss maintenance', 'child BMIz change over time', 'weight loss', 'child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",150.0,0.0200187,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA. kboutelle@ucsd.edu.'}, {'ForeName': 'D Eastern', 'Initials': 'DE', 'LastName': 'Kang Sim', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, La Jolla, CA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0463-4']
245,32271358,Association of 2-Year Progression Along the AREDS AMD Scale and Development of Late Age-Related Macular Degeneration or Loss of Visual Acuity: AREDS Report 41.,"Importance


The Age-Related Eye Disease Study age-related macular degeneration (AREDS AMD) scale is designed to classify AMD severity. The present cohort study explored whether 2-year progression along this scale was useful for estimating the risk of future progression to late AMD or best-corrected visual acuity (BCVA) loss.
Objective


To assess whether 2-year progression along the AREDS AMD scale can be used to estimate the probability of long-term clinically meaningful outcome measures for clinical trials or epidemiologic studies.
Design, Setting, and Participants


Age-Related Eye Disease Study participants enrolled in a clinical trial of oral micronutrient supplements had annual color fundus photographs graded centrally using the AREDS AMD scale. Two-year progression (≥2-step and ≥3-step increases in AMD score between baseline and the 2-year study visit) was evaluated as a method of estimating the risk of long-term progression to late AMD or BCVA loss. The AREDS (1992-2001) was a randomized, placebo-controlled clinical trial based at 11 retinal specialty clinics in the United States. The dates of analysis in the present cohort study were November 1992 through November 2005.
Main Outcomes and Measures


Development of neovascular (NV) AMD, central geographic atrophy (CGA), any geographic atrophy (GA), or BCVA loss of at least 2 lines or at least 3 lines.
Results


Among 3868 participants in the AREDS free of late AMD at baseline, the mean (SD) age was 68.3 (5.0) years, and 2180 of 3868 (56.4%) were women. In the first 2 years after randomization to the AREDS, 669 of 7458 (9.0%) of eyes had at least 2-step 2-year progression, and 275 of 7458 (3.7%) of eyes had at least 3-step 2-year progression. In the 5-year follow-up period (years 2-7), 486 of 7223 (6.7%) of eyes developed NV AMD, 339 of 7253 (4.7%) developed CGA, 726 of 7246 (10.0%) developed any GA, 2622 of 7095 (37.0%) had at least 2-line BCVA loss, and 1494 of 7155 (20.9%) had at least 3-line BCVA loss. After adjusting for demographic and clinical confounders and stratifying by baseline AMD score, statistically significant associations were observed between at least 2-step and at least 3-step 2-year progression of AMD score and subsequent 5-year development of NV AMD: hazard ratios (HRs) ranged from 3.6 (99% CI, 2.4-5.2) to 19.4 (99% CI, 7.7-48.9). For CGA, HRs ranged from 2.6 (99% CI, 1.7-4.0) to 4.7 (99% CI, 2.5-8.9); the results were similar for any GA. For at least 2-line and at least 3-line BCVA loss, HRs ranged from 1.3 (99% CI, 1.0-1.7) to 2.8 (99% CI, 1.8-4.3). For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression. These findings were also validated in the AREDS2 cohort.
Conclusions and Relevance


Two-year progression of AMD score was associated with progression to clinically meaningful anatomic (late AMD) and vision (≥2-line or ≥3-line loss) outcomes, suggesting that this scale may be useful for future clinical trials designed to slow the progression of AMD.",2020,"For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression.","['Participants\n\n\nAge-Related Eye Disease Study participants enrolled in a clinical trial of', '3868 participants in the AREDS free of late AMD at baseline, the mean (SD) age was 68.3 (5.0) years, and 2180 of 3868 (56.4%) were women', '11 retinal specialty clinics in the United States']","['placebo', 'oral micronutrient supplements']","['least 2-line BCVA loss', 'Measures\n\n\nDevelopment of neovascular (NV) AMD, central geographic atrophy (CGA), any geographic atrophy (GA), or BCVA loss of at least 2 lines or at least 3 lines', 'AMD score', 'AMD score and subsequent 5-year development of NV AMD: hazard ratios (HRs', 'annual color fundus photographs graded centrally using the AREDS AMD scale', 'risk of future progression to late AMD or best-corrected visual acuity (BCVA) loss']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015397', 'cui_str': 'Disorder of eye'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",,0.0716089,"For all outcomes, at least 3-step 2-year progression had stronger associations than at least 2-step 2-year progression.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Vitale', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland.'}, {'ForeName': 'Tiarnan D L', 'Initials': 'TDL', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin-Madison.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Danis', 'Affiliation': 'Fundus Photograph Reading Center, University of Wisconsin-Madison.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0824']
246,32271377,Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial.,"Importance


Checkpoint inhibitors targeting programmed cell death 1 or its ligand (PD-L1) as monotherapies or in combination with anti-cytotoxic T-lymphocyte-associated antigen 4 have shown clinical activity in patients with metastatic non-small cell lung cancer.
Objective


To compare durvalumab, with or without tremelimumab, with chemotherapy as a first-line treatment for patients with metastatic non-small cell lung cancer.
Design, Setting, and Participants


This open-label, phase 3 randomized clinical trial (MYSTIC) was conducted at 203 cancer treatment centers in 17 countries. Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations were randomized to receive treatment with durvalumab, durvalumab plus tremelimumab, or chemotherapy. Data were collected from July 21, 2015, to October 30, 2018.
Interventions


Patients were randomized (1:1:1) to receive treatment with durvalumab (20 mg/kg every 4 weeks), durvalumab (20 mg/kg every 4 weeks) plus tremelimumab (1 mg/kg every 4 weeks, up to 4 doses), or platinum-based doublet chemotherapy.
Main Outcomes and Measures


The primary end points, assessed in patients with ≥25% of tumor cells expressing PD-L1, were overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS) for durvalumab plus tremelimumab vs chemotherapy. Analysis of blood tumor mutational burden (bTMB) was exploratory.
Results


Between July 21, 2015, and June 8, 2016, 1118 patients were randomized. Baseline demographic and disease characteristics were balanced between treatment groups. Among 488 patients with ≥25% of tumor cells expressing PD-L1, median OS was 16.3 months (95% CI, 12.2-20.8) with durvalumab vs 12.9 months (95% CI, 10.5-15.0) with chemotherapy (hazard ratio [HR], 0.76; 97.54% CI, 0.56-1.02; P = .04 [nonsignificant]). Median OS was 11.9 months (95% CI, 9.0-17.7) with durvalumab plus tremelimumab (HR vs chemotherapy, 0.85; 98.77% CI, 0.61-1.17; P = .20). Median PFS was 3.9 months (95% CI, 2.8-5.0) with durvalumab plus tremelimumab vs 5.4 months (95% CI, 4.6-5.8) with chemotherapy (HR, 1.05; 99.5% CI, 0.72-1.53; P = .71). Among 809 patients with evaluable bTMB, those with a bTMB ≥20 mutations per megabase showed improved OS for durvalumab plus tremelimumab vs chemotherapy (median OS, 21.9 months [95% CI, 11.4-32.8] vs 10.0 months [95% CI, 8.1-11.7]; HR, 0.49; 95% CI, 0.32-0.74). Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy. These adverse events led to death in 2 (0.5%), 6 (1.6%), and 3 (0.9%) patients, respectively.
Conclusions and Relevance


The phase 3 MYSTIC study did not meet its primary end points of improved OS with durvalumab vs chemotherapy or improved OS or PFS with durvalumab plus tremelimumab vs chemotherapy in patients with ≥25% of tumor cells expressing PD-L1. Exploratory analyses identified a bTMB threshold of ≥20 mutations per megabase for optimal OS benefit with durvalumab plus tremelimumab.
Trial Registration


ClinicalT rials.gov Identifier: NCT02453282.",2020,"Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy.","['Patients with treatment-naive, metastatic non-small cell lung cancer who had no sensitizing EGFR or ALK genetic alterations', '369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with', '1118 patients were randomized', '203 cancer treatment centers in 17 countries', 'Metastatic Non-Small Cell Lung Cancer', '488 patients with ≥25% of', '809 patients with evaluable bTMB', 'Data were collected from July 21, 2015, to October 30, 2018', 'patients with metastatic non-small cell lung cancer']","['Durvalumab With or Without Tremelimumab vs Standard Chemotherapy', 'durvalumab, with or without tremelimumab, with chemotherapy', 'chemotherapy', 'durvalumab, durvalumab plus tremelimumab, or chemotherapy', 'durvalumab vs chemotherapy', 'tremelimumab', 'durvalumab', 'platinum-based doublet chemotherapy']","['blood tumor mutational burden (bTMB', 'overall survival (OS) for durvalumab vs chemotherapy, and OS and progression-free survival (PFS', 'tumor cells expressing PD-L1, median OS', 'Median PFS', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",1118.0,0.235187,"Treatment-related adverse events of grade 3 or higher occurred in 55 (14.9%) of 369 patients who received treatment with durvalumab, 85 (22.9%) of 371 patients who received treatment with durvalumab plus tremelimumab, and 119 (33.8%) of 352 patients who received treatment with chemotherapy.","[{'ForeName': 'Naiyer A', 'Initials': 'NA', 'LastName': 'Rizvi', 'Affiliation': 'Division of Hematology/Oncology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Reinmuth', 'Affiliation': 'Asklepios Lung Clinic, Munich-Gauting, Germany.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Oncology No. 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Department of Hematology and Oncology, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Nederlands Kanker Instituut-Antoni van Leeuwenhoekziekenhuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Smolin', 'Affiliation': 'Department of Radiology, Burdenko Main Military Clinical Hospital, Moscow, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'Oncological Clinical Research Center, St Petersburg, Russia.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.'}, {'ForeName': 'Sylvestre', 'Initials': 'S', 'LastName': 'Le Moulec', 'Affiliation': 'Department of Medical Oncology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Robinet', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier Régional Universitaire de Brest-Hôpital Morvan, Brest, France.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Natale', 'Affiliation': 'Cedars-Sinai Comprehensive Cancer Center, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Department of Hematology and Oncology, NYU Winthrop Hospital, Mineola, New York.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Princess Margaret Cancer Centre and the Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sarayut Lucien', 'Initials': 'SL', 'LastName': 'Geater', 'Affiliation': 'Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Faculty of Medicine, Department of Medical Oncology, Kindai University, Osaka, Japan.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Raja', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boothman', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Luping', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Scheuring', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Stockman', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Vikram K', 'Initials': 'VK', 'LastName': 'Chand', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.0237']
247,32279619,Clinical and Imaging Determinants of Collateral Status in Patients With Acute Ischemic Stroke in MR CLEAN Trial and Registry.,"Background and Purpose- Collateral circulation status at baseline is associated with functional outcome after ischemic stroke and effect of endovascular treatment. We aimed to identify clinical and imaging determinants that are associated with collateral grade on baseline computed tomography angiography in patients with acute ischemic stroke due to an anterior circulation large vessel occlusion. Methods- Patients included in the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; n=500) and MR CLEAN Registry (n=1488) were studied. Collateral status on baseline computed tomography angiography was scored from 0 (absent) to 3 (good). Multivariable ordinal logistic regression analyses were used to test the association of selected determinants with collateral status. Results- In total, 1988 patients were analyzed. Distribution of the collateral status was as follows: absent (7%, n=123), poor (32%, n=596), moderate (39%, n=735), and good (23%, n=422). Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886-0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53-0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95-1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41-0.61]). In contrast to previous studies, we did not find an association between cardiovascular risk factors and collateral status. Conclusions- Older age, male sex, high glucose levels, and intracranial internal carotid artery with occlusion of the terminus occlusions are associated with poor computed tomography angiography collateral grades in patients with acute ischemic stroke eligible for endovascular treatment.",2020,"Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886-0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53-0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95-1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41-0.61]).","['patients with acute ischemic stroke eligible for endovascular treatment', 'patients with acute ischemic stroke due to an anterior circulation large vessel occlusion', 'Patients With Acute Ischemic Stroke in MR CLEAN Trial and Registry', '1988 patients were analyzed']","[' and Purpose', 'Endovascular Treatment']","['blood glucose level', 'Collateral circulation status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",1988.0,0.0982939,"Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886-0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53-0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95-1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41-0.61]).","[{'ForeName': 'Eveline J A', 'Initials': 'EJA', 'LastName': 'Wiegers', 'Affiliation': 'From the Department of Public Health (E.J.A.W., E.V., H.F.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Maxim J H L', 'Initials': 'MJHL', 'LastName': 'Mulder', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Ivo G H', 'Initials': 'IGH', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Esmee', 'Initials': 'E', 'LastName': 'Venema', 'Affiliation': 'From the Department of Public Health (E.J.A.W., E.V., H.F.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Kars C J', 'Initials': 'KCJ', 'LastName': 'Compagne', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Olvert A', 'Initials': 'OA', 'LastName': 'Berkhemer', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Henk A', 'Initials': 'HA', 'LastName': 'Marquering', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Adriaan C G M', 'Initials': 'ACGM', 'LastName': 'van Es', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.J.H.L.M., K.C.J.C., O.A.B., A.C.G.M.v.E., B.R., A.v.d.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Sprengers', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Zwam', 'Affiliation': 'Cardiovascular Research Institute Maastricht, the Netherlands (O.A.B., W.H.v.Z., R.J.v.O.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'van Oostenbrugge', 'Affiliation': 'Cardiovascular Research Institute Maastricht, the Netherlands (O.A.B., W.H.v.Z., R.J.v.O.).'}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Academic Medical Center, Amsterdam, the Netherlands (Y.B.W.E.M.R.).'}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology and Nuclear Medicine (I.G.H.J., B.J.E., H.A.M., M.E.S., C.B.L.M.M.), Amsterdam UMC, location AMC, the Netherlands.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Roozenbeek', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Hester F', 'Initials': 'HF', 'LastName': 'Lingsma', 'Affiliation': 'From the Department of Public Health (E.J.A.W., E.V., H.F.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': 'Department of Neurology (M.J.H.L.M., E.V., K.C.J.C., O.A.B., B.R., D.W.J.D.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Aad', 'Initials': 'A', 'LastName': 'van der Lugt', 'Affiliation': 'Department of Radiology and Nuclear Medicine (M.J.H.L.M., K.C.J.C., O.A.B., A.C.G.M.v.E., B.R., A.v.d.L.), Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027483']
248,31470740,Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting.,"BACKGROUND


We tested the safety and performance of the ""insulin-only"" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points.
METHOD


This is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis.
RESULTS


Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL,  P  = .004) but not in the dynamic set-point arm (154 ± 10 mg/dL,  P  = ns). There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms. There was less time <70 mg/dL with both the static (1.8% ± 1.4%,  P  = .009) and dynamic set-point (2.7±1.5,  P  = .051) arms compared to the usual-care arm (5.5% ± 4.2%). HF testing demonstrated preliminary user satisfaction and no increased risk of diabetes burden or distress.
CONCLUSIONS


The insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.",2019,There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms.,"['Thirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg']","['Insulin-Only Bionic Pancreas', 'insulin-only"" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system']","['risk of diabetes burden or distress', 'time spent']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1300561', 'cui_str': 'unit/kg'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",13.0,0.0292158,There was no significant difference in time spent in range (70-180 mg/dL) among the three study arms.,"[{'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Nally', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Firas H', 'Initials': 'FH', 'LastName': 'El-Khatib', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Trang T', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Clinton', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Molly L', 'Initials': 'ML', 'LastName': 'Tanenbaum', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Hanes', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Rajendranath R', 'Initials': 'RR', 'LastName': 'Selagamsetty', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Damiano', 'Affiliation': 'Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.'}]",Journal of diabetes science and technology,['10.1177/1932296819872225']
249,31094229,The Impact of Pre-Cooling and CoQ 10  Supplementation on Mediators of Inflammatory Cytokines in Elite Swimmers.,"Chronic intensive exercise and hyperthermia may cause immune system function disturbance. We aimed to investigate the effect of 14-day coenzyme Q 10  (CoQ 10 ) supplementation and pre-cooling strategy on serum changes of inflammatory cytokines [interleukin-10 (IL-10), interleukin-8 (IL-8), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)], and high-sensitivity C-reactive protein (hs-CRP), myeloperoxidase (MPO) and xanthine oxidase (XO) enzymes, leukocyte counts (WBC), and stress hormones (catecholamine and cortisol) responses in elite swimmers during competition phase. Thirty-six healthy males were randomly selected and divided into four groups of CoQ 10 , precooling, supplementation with precooling, and control. Blood sampling was done pre and post (before and after acute recoding bout) administration of CoQ 10  and pre-cooling. There was no significant statistical difference among groups for the indices levels of IL-10, IL-8, IL-6, TNF-α, hs-CRP, catecholamine, cortisol, MPO, XO, and WBC counts at the pre sampling ( P  > 0.05). While, pre-cooling and control groups show a significant increase indices levels compared to the supplementation and supplementation with precooling groups in the post-sampling (two stages), ( P  ˂ 0.05). Short-term oral CoQ 10  supplementation prevents adverse changes mediators of inflammatory cytokines following heavy swimming trainings and acute recording bout. In addition, pre-cooling strategy individually has no desired effect on the mediators of inflammatory cytokines.",2020,"There was no significant statistical difference among groups for the indices levels of IL-10, IL-8, IL-6, TNF-α, hs-CRP, catecholamine, cortisol, MPO, XO, and WBC counts at the pre sampling (P > 0.05).","['Thirty-six healthy males', 'elite swimmers during competition phase', 'Elite Swimmers']","['Pre-Cooling and CoQ 10  Supplementation', 'CoQ 10 , precooling, supplementation with precooling, and control', '14-day coenzyme Q 10  (CoQ 10 ) supplementation and pre-cooling strategy']","['serum changes of inflammatory cytokines [interleukin-10 (IL-10), interleukin-8 (IL-8), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α)], and high-sensitivity C-reactive protein (hs-CRP), myeloperoxidase (MPO) and xanthine oxidase (XO) enzymes, leukocyte counts (WBC), and stress hormones (catecholamine and cortisol) responses', 'indices levels of IL-10, IL-8, IL-6, TNF-α, hs-CRP, catecholamine, cortisol, MPO, XO, and WBC counts']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2242675', 'cui_str': 'Coenzyme Q'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0043317', 'cui_str': 'Hypoxanthine Dehydrogenase'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0007412', 'cui_str': 'Sympathins'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0912079', 'cui_str': 'myelopoietin'}]",36.0,0.0986899,"There was no significant statistical difference among groups for the indices levels of IL-10, IL-8, IL-6, TNF-α, hs-CRP, catecholamine, cortisol, MPO, XO, and WBC counts at the pre sampling (P > 0.05).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Emami', 'Affiliation': 'Department of Exercise Physiology and Corrective Movement, Sport Sciences Faculty, Urmia University, Urmia, Iran.'}]",Nutrition and cancer,['10.1080/01635581.2019.1614200']
250,31135225,The Effects of Synbiotic Supplementation on Antioxidant Capacity and Arm Volumes in Survivors of Breast Cancer-Related Lymphedema.,"Background and Aims:  Synbiotics found to be beneficial in breast cancer survivors (BCSs) through its antioxidant properties. The aim of this study was to assess the effects of synbiotic supplementation on edema volume and some oxidative markers among obese and overweight patients with BCRL. Method:  This randomized double-blind, placebo-controlled trial was conducted on 88 overweight and obese BCSs aged 18-65 years. All the subjects were given a specified low-calorie diet (LCD) and were randomly assigned into two groups to intake 10 9  CFU/day synbiotic supplement ( n  = 44) or placebo ( n  = 44) for 10 wk. Edema volume and serum total antioxidant capacity (TAC), malondialdehyde (MDA), glutathione peroxidase (GPx), and superoxide dismutase (SOD) concentration were measured at baseline and after the 10-wk intervention. Results:  Ten-wk supplementation with synbiotics leads to a significant reduction in serum MDA levels ( P  = 0.001) and an increase in serum SOD concentration ( P  = 0.007) compared to placebo. No significant changes were observed in serum GPx, TAC, and edema volume between groups. Conclusion:  Our findings reveal that 10-wk synbiotic supplementation along with a LCD program-reduced serum MDA levels and elevate the activity of SOD in overweight and obese patients with BCRL. However, its effect on serum GPx, TAC, and edema volume was not significant.",2020,Ten-wk supplementation with synbiotics leads to a significant reduction in serum MDA levels ( P  = 0.001) and an increase in serum SOD concentration ( P  = 0.007) compared to placebo.,"['overweight and obese patients with BCRL', 'obese and overweight patients with BCRL', 'breast cancer survivors (BCSs', 'Survivors of Breast Cancer-Related Lymphedema', '88 overweight and obese BCSs aged 18-65\u2009years']","['placebo', 'Synbiotic Supplementation', 'intake 10 9  CFU/day synbiotic supplement', 'specified low-calorie diet (LCD', 'synbiotic supplementation']","['edema volume and some oxidative markers', 'serum GPx, TAC, and edema volume', 'serum SOD concentration', 'serum MDA levels', 'activity of SOD', 'Edema volume and serum total antioxidant capacity (TAC), malondialdehyde (MDA), glutathione peroxidase (GPx), and superoxide dismutase (SOD) concentration', 'Antioxidant Capacity and Arm Volumes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",88.0,0.225575,Ten-wk supplementation with synbiotics leads to a significant reduction in serum MDA levels ( P  = 0.001) and an increase in serum SOD concentration ( P  = 0.007) compared to placebo.,"[{'ForeName': 'Mehraban', 'Initials': 'M', 'LastName': 'Navaei', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Saneei Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Raji Lahiji', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Emamat', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Salehi', 'Affiliation': 'Immunology Department, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Amirinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Izad', 'Affiliation': 'Immunology Department, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran Iran.'}]",Nutrition and cancer,['10.1080/01635581.2019.1616781']
251,31155953,Sulforaphane Bioavailability and Chemopreventive Activity in Men Presenting for Biopsy of the Prostate Gland: A Randomized Controlled Trial.,"Previous studies suggest compounds such as sulforaphane (SFN) derived from cruciferous vegetables may prevent prostate cancer development and progression. This study evaluated the effect of broccoli sprout extract (BSE) supplementation on blood histone deacetylase (HDAC) activity, prostate RNA gene expression, and tissue biomarkers (histone H3 lysine 18 acetylation (H3K18ac), HDAC3, HDAC6, Ki67, and p21). A total of 98 men scheduled for prostate biopsy were allocated into either BSE (200 µmol daily) or a placebo in our double-blind, randomized controlled trial. We used nonparametric tests to evaluate the differences of blood HDAC activity and prostate tissue immunohistochemistry biomarkers between treatment groups. Further, we performed RNA-Seq analysis on the prostate biopsies and identified 40 differentially expressed genes correlated with BSE treatment, including downregulation of two genes previously implicated in prostate cancer development,  AMACR  and  ARLNC1 . Although urine and plasma SFN isothiocyanates and individual SFN metabolites were statistically higher in the treatment group, our results did not show a significant difference in HDAC activity or prostate tissue biomarkers. This study indicates BSE supplementation correlates with changes in gene expression but not with several other prostate cancer biomarkers. More research is required to fully understand the chemopreventive effects of BSE supplementation on prostate cancer.",2020,"Although urine and plasma SFN isothiocyanates and individual SFN metabolites were statistically higher in the treatment group, our results did not show a significant difference in HDAC activity or prostate tissue biomarkers.","['98 men scheduled for prostate biopsy', 'Men Presenting for Biopsy of the Prostate Gland']","['BSE supplementation', 'placebo', 'sulforaphane (SFN', 'BSE', 'broccoli sprout extract (BSE) supplementation']","['blood histone deacetylase (HDAC) activity, prostate RNA gene expression, and tissue biomarkers (histone H3 lysine 18 acetylation (H3K18ac), HDAC3, HDAC6, Ki67, and p21', 'Sulforaphane Bioavailability and Chemopreventive Activity', 'urine and plasma SFN isothiocyanates and individual SFN metabolites', 'HDAC activity or prostate tissue biomarkers', 'blood HDAC activity and prostate tissue immunohistochemistry biomarkers']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C1707048', 'cui_str': 'broccoli sprout extract'}]","[{'cui': 'C0005768'}, {'cui': 'C0019643', 'cui_str': 'HDAC Proteins'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019647', 'cui_str': 'Histone H3'}, {'cui': 'C0024337', 'cui_str': 'L-lysine'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0080058', 'cui_str': 'Proto-Oncogene Proteins p21(ras)'}, {'cui': 'C0163159', 'cui_str': '4-methylsulphinylbutyl glucosinolate'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0042037'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}]",98.0,0.0983991,"Although urine and plasma SFN isothiocyanates and individual SFN metabolites were statistically higher in the treatment group, our results did not show a significant difference in HDAC activity or prostate tissue biomarkers.","[{'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Division of Hematology and Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Garzotto', 'Affiliation': 'Department of Urology, Portland Veterans Administration Medical Center, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Davis', 'Affiliation': 'School of Biological and Population Health Science, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Motomi', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Division of Hematology and Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Stoller', 'Affiliation': 'Division of Hematology and Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Farris', 'Affiliation': 'Division of Hematology and Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'Wong', 'Affiliation': 'School of Biological and Population Health Science, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Beaver', 'Affiliation': 'School of Biological and Population Health Science, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'George V', 'Initials': 'GV', 'LastName': 'Thomas', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Williams', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Roderick H', 'Initials': 'RH', 'LastName': 'Dashwood', 'Affiliation': 'Center for Epigenetics & Disease Prevention, Texas A&M College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Hendrix', 'Affiliation': 'Department of Biochemistry and Biophysics, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ho', 'Affiliation': 'School of Biological and Population Health Science, Oregon State University, Corvallis, Oregon, USA.'}, {'ForeName': 'Jackilen', 'Initials': 'J', 'LastName': 'Shannon', 'Affiliation': 'Division of Hematology and Oncology, Oregon Health & Science University, Portland, Oregon, USA.'}]",Nutrition and cancer,['10.1080/01635581.2019.1619783']
252,32096852,Comparison of Abbreviated Breast MRI vs Digital Breast Tomosynthesis for Breast Cancer Detection Among Women With Dense Breasts Undergoing Screening.,"Importance


Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.
Objective


To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.
Design, Setting, and Participants


Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.
Exposures


All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.
Main Outcomes and Measures


The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.
Results


Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).
Conclusions and Relevance


Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT02933489.",2020,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","['Women With Dense Breasts Undergoing Screening', 'women with dense breasts', '17 women with invasive cancer and 2 of 6 women with DCIS', '1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis', 'Breast Cancer Detection', 'Participants\n\n\nCross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening', '17 women with invasive cancer and 5 of 6 women with DCIS']","['abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT', 'Abbreviated Breast MRI vs Digital Breast Tomosynthesis']","['additional imaging recommendation rate', 'PPV', 'No interval cancers', 'sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS', 'invasive cancer detection rate', 'rate of invasive breast cancer detection', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C2919572', 'cui_str': 'Malignant neoplasm detection during interval between recommended screening examinations (finding)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]",1516.0,0.363375,"For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001).","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Comstock', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Gatsonis', 'Affiliation': 'Department of Biostatistics and Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Newstead', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ilana F', 'Initials': 'IF', 'LastName': 'Gareen', 'Affiliation': 'Center for Statistical Sciences, Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Bergin', 'Affiliation': 'UW Cancer Center at ProHealth Care, Waukesha, Wisconsin.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Rahbar', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Janice S', 'Initials': 'JS', 'LastName': 'Sung', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jacobs', 'Affiliation': 'West Michigan Cancer Center, Kalamazoo.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Harvey', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Mary H', 'Initials': 'MH', 'LastName': 'Nicholson', 'Affiliation': 'Community Hospital, Munster, Indiana.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Ward', 'Affiliation': 'Rhode Island Hospital, Providence.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prather', 'Affiliation': 'Gundersen Health System, La Crosse, Wisconsin.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Indiana University, Indianapolis.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Schnall', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Christiane K', 'Initials': 'CK', 'LastName': 'Kuhl', 'Affiliation': 'University Hospital of RWTH Aachen, Aachen, Germany.'}]",JAMA,['10.1001/jama.2020.0572']
253,32132264,The Right Temporoparietal Junction Is Causally Associated with Embodied Perspective-taking.,"A prominent theory claims that the right temporoparietal junction (rTPJ) is especially associated with embodied processes relevant to perspective-taking. In the present study, we use high-definition transcranial direct current stimulation to provide evidence that the rTPJ is causally associated with the embodied processes underpinning perspective-taking. Eighty-eight young human adults were stratified to receive either rTPJ or dorsomedial PFC anodal high-definition transcranial direct current stimulation in a sham-controlled, double-blind, repeated-measures design. Perspective-tracking (line-of-sight) and perspective-taking (embodied rotation) were assessed using a visuo-spatial perspective-taking task that required understanding what another person could see or how they see it, respectively. Embodied processing was manipulated by positioning the participant in a manner congruent or incongruent with the orientation of an avatar on the screen. As perspective-taking, but not perspective-tracking, is influenced by bodily position, this allows the investigation of the specific causal role for the rTPJ in embodied processing. Crucially, anodal stimulation to the rTPJ increased the effect of bodily position during perspective-taking, whereas no such effects were identified during perspective-tracking, thereby providing evidence for a causal role for the rTPJ in the embodied component of perspective-taking. Stimulation to the dorsomedial PFC had no effect on perspective-tracking or taking. Therefore, the present study provides support for theories postulating that the rTPJ is causally involved in embodied cognitive processing relevant to social functioning. SIGNIFICANCE STATEMENT  The ability to understand another's perspective is a fundamental component of social functioning. Adopting another perspective is thought to involve both embodied and nonembodied processes. The present study used high-definition transcranial direct current stimulation (HD-tDCS) and provided causal evidence that the right temporoparietal junction is involved specifically in the embodied component of perspective-taking. Specifically, HD-tDCS to the right temporoparietal junction, but not another hub of the social brain (dorsomedial PFC), increased the effect of body position during perspective-taking, but not tracking. This is the first causal evidence that HD-tDCS can modulate social embodied processing in a site-specific and task-specific manner.",2020,Stimulation to the dmPFC had no effect on perspective tracking or taking.,['Eighty-eight young human adults'],"['right temporoparietal junction (rTPJ', 'HD-tDCS', 'high-definition transcranial direct current stimulation (HD-tDCS', 'rTPJ', 'Perspective tracking (line-of-sight) and perspective taking (embodied rotation) were assessed using a visuo-spatial perspective taking (VPT) task', 'rTPJ or dorsomedial prefrontal (dmPFC) anodal HD-tDCS']",[],"[{'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",[],88.0,0.0306805,Stimulation to the dmPFC had no effect on perspective tracking or taking.,"[{'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Martin', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029, a.martin11@uq.edu.au.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kessler', 'Affiliation': 'Aston Neuroscience Institute, School of Life and Health Sciences, Aston University, Birmingham, United Kingdom B4 7ET, and.'}, {'ForeName': 'Shena', 'Initials': 'S', 'LastName': 'Cooke', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Meinzer', 'Affiliation': 'UQ Centre for Clinical Research, University of Queensland, Brisbane, Australia 4029.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2637-19.2020']
254,31710340,"Reactions to Multiple Ascending Doses of the Microtubule Stabilizer TPI-287 in Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome: A Randomized Clinical Trial.","Importance


Basket-design clinical trials that allow investigation of treatment effects on different clinical syndromes that share the same molecular pathophysiology have not previously been attempted in neurodegenerative disease.
Objective


To assess the safety, tolerability, and pharmacodynamics of the microtubule stabilizer TPI-287 (abeotaxane) in Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).
Design, Setting, and Participants


Two parallel-design, double-blind, placebo-controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham. A total of 94 patients with clinically diagnosed AD (n = 39) and 4RT (n = 55) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria. A total of 29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled. Data were analyzed from December 20, 2013, through May 4, 2017, based on modified intention to treat.
Interventions


Randomization was 8:3 drug to placebo in 3 sequential dose cohorts receiving 2.0, 6.3, or 20.0 mg/m2 of intravenous TPI-287 once every 3 weeks for 9 weeks, with an optional 6-week open-label extension.
Main Outcomes and Measures


Primary end points were safety and tolerability (maximal tolerated dose) of TPI-287. Secondary and exploratory end points included TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures.
Results


A total of 68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT (16 women [38%]; median age, 69 [range, 54-83] years). Three severe anaphylactoid reactions occurred in TPI-287-treated patients with AD, whereas none were seen in patients with 4RT, leading to a maximal tolerated dose of 6.3 mg/m2 for AD and 20.0 mg/m2 for 4RT. More falls (3 in the placebo group vs 11 in the TPI-287 group) and a dose-related worsening of dementia symptoms (mean [SD] in the CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures], 0.5 [1.8] in the placebo group vs 0.7 [1.6] in the TPI-287 group; median difference, 1.5 [95% CI, 0-2.5]; P = .03) were seen in patients with 4RT. Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 [26.0] ng/mL) compared with placebo (mean [SD], 10.4 [42.3] ng/mL; median difference, -14.6 [95% CI, -30.0 to 0.2] ng/mL; P = .048, Mann-Whitney test).
Conclusions and Relevance


In this randomized clinical trial, TPI-287 was less tolerated in patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions. The ability to reveal different tau therapeutic effects in various tauopathy syndromes suggests that basket trials are a valuable approach to tau therapeutic early clinical development.
Trial Registration


ClinicalTrials.gov identifiers: NCT019666666 and NCT02133846.",2020,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","['29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled', '94 patients with clinically diagnosed AD (n\u2009=\u200939) and 4RT (n\u2009=\u200955) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria', '16 women [38%]; median age, 69 [range, 54-83] years', 'patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions', 'Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome', 'Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS', 'controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham', '68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT']","['microtubule stabilizer TPI-287 (abeotaxane', 'placebo', 'Microtubule Stabilizer TPI-287', 'TPI-287']","['safety and tolerability (maximal tolerated dose) of TPI-287', 'CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures', 'severe anaphylactoid reactions', 'TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures', 'worsening of dementia symptoms', 'safety, tolerability, and pharmacodynamics', 'chitinase-3-like protein-1 (YKL-40) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0949664', 'cui_str': 'Tauopathies'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0026046', 'cui_str': 'Microtubules'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0751072', 'cui_str': 'FTLD'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal Lobe Dementia (FLDEM)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027903', 'cui_str': 'Neuropsychologies'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3872855', 'cui_str': 'GP-39 Protein'}]",68.0,0.508308,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Tsai', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Koestler', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Rojas', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ljubenkov', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Rosen', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Gil D', 'Initials': 'GD', 'LastName': 'Rabinovici', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Cobigo', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Joo In', 'Initials': 'JI', 'LastName': 'Jung', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hare', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Natelson-Love', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'McKinley', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Luong', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emmeline L', 'Initials': 'EL', 'LastName': 'Chuu', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Powers', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Mumford', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Merhdad', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Wu Tsai Neurosciences Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Roberson', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3812']
255,32101308,Systematic Dementia Screening by Multidisciplinary Team Meetings in Nursing Homes for Reducing Emergency Department Transfers: The IDEM Cluster Randomized Clinical Trial.,"Importance


Dementia is often underdiagnosed in nursing homes (NHs). This potentially results in inappropriate care, and high rates of emergency department (ED) transfers in particular.
Objective


To assess whether systematic dementia screening of NH residents combined with multidisciplinary team meetings resulted in a lower rate of ED transfer at 12 months compared with usual care.
Design, Setting, and Participants


Multicenter, cluster randomized trial with NHs as the unit of randomization. The IDEM (Impact of Systematic Tracking of Dementia Cases on the Rate of Hospitalization in Emergency Care Units) trial took place at 64 public and private NHs in France. Recruitment started on May 1, 2010, and was completed on March 31, 2012. Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included. The residents were followed up for 18 months. The main study analyses were completed on October 14, 2016.
Intervention


Two parallel groups were compared: an intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice. During the inclusion period of 23 months, all residents of participating NHs who met eligibility criteria were included in the study.
Main Outcomes and Measures


The primary end point (ED transfer) was analyzed at 12 months, but the residents included were followed up for 18 months.
Results


A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs). The final study visit was completed by 1042 residents (73.0%). The main reason for early discontinuation was death (318 residents [22.7%]). The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
Conclusions and Relevance


This study failed to demonstrate that systematic screening for dementia in NHs resulted in fewer ED transfers. The findings do not support implementation of multidisciplinary team meetings for systematic dementia screening of all NH residents, beyond the national recommendations for dementia diagnosis, to reduce ED transfers.
Trial Registration


ClinicalTrials.gov Identifier: NCT01569997.",2020,"The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
","['1042 residents (73.0', 'Residents who were aged 60 years or older, had no diagnosed or documented dementia, were not bedridden, had lived in the NH for at least 1 month at inclusion, and had a life expectancy greater than 12 months were included', 'A total of 64 NHs participated in the study and enrolled 1428 residents (mean [SD] age, 84.7 [8.1] years; 1019 [71.3%] female): 599 in the intervention group (32 NHs) and 829 in the control group (32 NHs', '64 public and private NHs in France', 'Nursing Homes for Reducing Emergency Department Transfers', 'all residents of participating NHs who met eligibility criteria were included in the study']","['NH residents combined with multidisciplinary team meetings', 'intervention group consisting of NHs that set up 2 multidisciplinary team meetings to identify residents with dementia and to discuss an appropriate care plan, and a control group consisting of NHs that continued their usual practice']","['rate of ED transfer', 'risk of ED transfers']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0741453', 'cui_str': 'Bedridden'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",64.0,0.119132,"The intervention did not reduce the risk of ED transfers during the 12-month follow-up: the proportion of residents transferred at least once to an ED during the 12-month follow-up was 16.2% in the intervention group vs 12.8% in the control group (odds ratio, 1.32; 95% CI, 0.83-2.09; P = .24).
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Tavassoli', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Laffon de Mazières', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rapp', 'Affiliation': 'LIRAES (EA 4470) & Chaire AGEINOMIX, Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hermabessière', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Tournay', 'Affiliation': 'Unité de Soutien Méthodologique à la Recherche, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Andrieu', 'Affiliation': 'Gérontopôle de Toulouse, Département de Médecine Interne et Gérontologie Clinique, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0049']
256,32270891,Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST).,"Dynamic resistance exercise (DRT) might be the most promising agent for fighting sarcopenia in older people. However, the positive effect of DRT on osteopenia/osteoporosis in men has still to be confirmed. To evaluate the effect of low-volume/high-intensity (HIT)-DRT on bone mineral density (BMD) and skeletal muscle mass index (SMI) in men with osteosarcopenia, we initiated the Franconian Osteopenia and Sarcopenia Trial (FrOST). Forty-three sedentary community-dwelling older men (aged 73 to 91 years) with osteopenia/osteoporosis and SMI-based sarcopenia were randomly assigned to a HIT-RT exercise group (EG; n = 21) or a control group (CG; n = 22). HIT-RT provided a progressive, periodized single-set DRT on machines with high intensity, effort, and velocity twice a week, while CG maintained their lifestyle. Both groups were adequately supplemented with whey protein, vitamin D, and calcium. Primary study endpoint was integral lumbar spine (LS) BMD as determined by quantitative computed tomography. Core secondary study endpoint was SMI as determined by dual-energy X-ray absorptiometry. Additional study endpoints were BMD at the total hip and maximum isokinetic hip-/leg-extensor strength (leg press). After 12 months of exercise, LS-BMD was maintained in the EG and decreased significantly in the CG, resulting in significant between-group differences (p < 0.001; standardized mean difference [SMD] = 0.90). In parallel, SMI increased significantly in the EG and decreased significantly in the CG (p < 0.001; SMD = 1.95). Total hip BMD changes did not differ significantly between the groups (p = 0.064; SMD = 0.65), whereas changes in maximum hip-/leg-extensor strength were much more prominent (p < 0.001; SMD = 1.92) in the EG. Considering dropout (n = 2), attendance rate (95%), and unintended side effects/injuries (n = 0), we believe our HIT-RT protocol to be feasible, attractive, and safe. In summary, we conclude that our combined low-threshold HIT-RT/protein/vitamin D/calcium intervention was feasible, safe, and effective for tackling sarcopenia and osteopenia/osteoporosis in older men with osteosarcopenia. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,"In parallel, SMI increased significantly in the EG and decreased significantly in the CG (p<.001, SMD: 1.95).","['Older Men with Osteosarcopenia - One-year results of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST', 'older people', 'men with osteosarcopenia, we initiated the Franconian Osteopenia and Sarcopenia Trial', 'older men with osteosarcopenia', 'Forty-three sedentary community dwelling older men (73-91\u2009years) with osteopenia/osteoporosis and SMI-based sarcopenia']","['High Intensity Resistance Training', 'low volume/high intensity (HIT)-DRT', 'HIT-RT exercise', 'Dynamic resistance exercise (DRT', 'whey protein, Vit-D and calcium', 'DRT', 'calcium intervention']","['maximum hip-/leg-extensor strength', 'Total hip BMD changes', 'osteopenia/osteoporosis', 'BMD at the total hip and maximum isokinetic hip-/leg-extensor strength (leg press', 'integral lumbar spine (LS) BMD', 'bone mineral density (BMD) and skeletal muscle mass index (SMI', 'Osteopenia and Sarcopenia parameters', 'attendance rate', 'skeletal muscle mass index (SMI) as determined by dual-energy-x-ray absorptiometry', 'LS-BMD']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3849574', 'cui_str': 'EPHB2 protein, human'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]",43.0,0.0184288,"In parallel, SMI increased significantly in the EG and decreased significantly in the CG (p<.001, SMD: 1.95).","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty Medical and Life Sciences, University of Furtwangen, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, University of Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Jakob', 'Affiliation': 'Bernhard-Heine-Center for Locomotion Research, Würzburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Engelke', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, Erlangen, Germany.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4027']
257,31319165,Trajectories of Changes in Renal Function in Patients with Acute Heart Failure.,"BACKGROUND


Changes in renal function have been associated with differential outcomes in patients with acute heart failure (HF). However, individual trajectories of changes in renal function are unknown, and it is unclear whether they relate to different clinical characteristics and clinical outcomes. Our aim was to investigate the prognostic importance of individual trajectories of change in renal function in acute HF.
METHODS


This was a retrospective, observational analysis from the double-blind, randomized, placebo-controlled PROTECT trial in patients with acute HF. We identified and internally validated 8 different renal trajectories among 1897 patients by visual inspection of inhospital serum creatinine changes. The primary outcome measure was all-cause mortality at 180 days. Mean age was 70 ± 12 years; 70% were male, and mean baseline estimated glomerular filtration rate was 49.0 mL/min/1.73m 2 .
RESULTS


A total of 8 different trajectories was established. The most prevalent trajectories were an inhospital bump (19.0%), a sustained increase (17.6%) and a dip (14.5%) in serum creatinine. Overall, the clinical characteristics of patients in different trajectories were remarkably similar. Crude 180-day mortality rates ranged from 12.0% in the trajectory, with no significant changes to 18.3% in the trajectory of sustained increase without significant differences. Overall, after multivariable adjustment, there was no trajectory of changes in renal function that was associated with significantly better or worse outcomes.
CONCLUSIONS


Trajectories of changes in renal function in acute HF differ considerably on the patient level. Despite these differences, clinical characteristics and outcomes were similar, therefore, questioning the prognostic importance of changes in renal function in acute HF.",2019,"Crude 180-day mortality rates ranged from 12.0% in the trajectory, with no significant changes to 18.3% in the trajectory of sustained increase without significant differences.","['1897 patients by visual inspection of inhospital serum creatinine changes', 'patients with acute heart failure (HF', 'Mean age was 70 ± 12 years; 70% were male, and mean baseline estimated glomerular filtration rate was 49.0 mL/min/1.73m 2 ', 'Patients with Acute Heart Failure', 'patients with acute HF']",['placebo'],"['cause mortality', 'Renal Function', 'renal function', 'Crude 180-day mortality rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3811844'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",1897.0,0.224639,"Crude 180-day mortality rates ranged from 12.0% in the trajectory, with no significant changes to 18.3% in the trajectory of sustained increase without significant differences.","[{'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Beldhuis', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Koen W', 'Initials': 'KW', 'LastName': 'Streng', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jozine M', 'Initials': 'JM', 'LastName': 'Ter Maaten', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'University of Brescia, Brescia, Italy.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Dittrich', 'Affiliation': 'Abboud Cardiovascular Research Center, University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Klinika Kardiologii, Wroclaw, Poland.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'John G F', 'Initials': 'JGF', 'LastName': 'Cleland', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton and Harefield Hospitals, Imperial College, London, UK.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'University of California, San Francisco and the San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bloomfield', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: k.damman@umcg.nl.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.07.004']
258,32273250,3D Printing Technology Improves Medical Interns' Understanding of Anatomy of Gastrocolic Trunk.,"OBJECTIVE


Complex vascular anatomy has always been a difficult point for medical students. Gastrocolic trunk (Henle trunk) has many branches and variations, involving the venous reflux of the stomach, right colon, and pancreas. This study investigated the effects of 3 dimensional (3D) printing technology on medical interns' understanding of Henle trunk's variation, by comparing 2 dimensional (2D) images.
SETTING


Henle trunk modes were manufactured using 3D-CT angiography and 3D-printing technology.
PARTICIPANTS


Forty-seven interns from 2 medical schools (Nanjing Medical University and Medical College of Nantong University) participated in the study.
DESIGN


The interns were divided randomly allocated into 2 groups, where group 1 was the control group with a 2D image of Henle trunk plus surgical video (named 2D image group), and group 2 was the study group with a 3D printed model of Henle trunk plus surgical video (named 3D-printing group). Knowledge of interns on the Henle trunk was compared between 2 groups using a question test before and after the teaching intervention.
RESULTS


All interns had an improved overall assessment score as a result of attending the seminar, whether in the 2D image group or the 3D-printing group. The score of the 2D image group increased 32.57 ± 13.86, and the 3D-printing group increased 47.04 ± 12.99, showing significant difference (p = 0.001). There was no significant difference observed between postseminar scores between 2 medical schools (p = 0.975). There was a significant improvement in satisfaction among the 3D-printing group for education depth, novel and inspiring of teaching method, except for the interaction between teacher and interns (p = 0.215). Interns hope to have more teaching time for 3D printing, and not satisfied with the time of 3D printing teaching compared with those in the 2D image group (p = 0.021).
CONCLUSIONS


The 3-D printed Henle trunk model is a very effective teaching tool, which can help interns understand the anatomy of Henle trunk. The application of 3D printing technology in the teaching of interns of complex vascular anatomy is worth popularizing in teaching hospitals.",2020,"There was a significant improvement in satisfaction among the 3D-printing group for education depth, novel and inspiring of teaching method, except for the interaction between teacher and interns (p = 0.215).",['Forty-seven interns from 2 medical schools (Nanjing Medical University and Medical College of Nantong University) participated in the study'],"['Gastrocolic trunk (Henle trunk', '3 dimensional (3D) printing technology', '3D-CT angiography and 3D-printing technology', 'control group with a 2D image of Henle trunk plus surgical video (named 2D image group), and group 2 was the study group with a 3D printed model of Henle trunk plus surgical video (named 3D-printing group', '3D Printing Technology']","['postseminar scores', 'satisfaction', 'overall assessment score']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C3849992', 'cui_str': 'Three-Dimensional Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",47.0,0.0189232,"There was a significant improvement in satisfaction among the 3D-printing group for education depth, novel and inspiring of teaching method, except for the interaction between teacher and interns (p = 0.215).","[{'ForeName': 'Yigang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Chunxiang', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': ""Department of Education and Researching, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Ruizhi', 'Initials': 'R', 'LastName': 'Shen', 'Affiliation': ""Department of Oncology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Danping', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': ""Department of Radiology, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Huiheng', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China.""}, {'ForeName': 'Zhequn', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Harbin JunYang Technology Co., Ltd., Harbin, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Education and Researching, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China. Electronic address: 19952266966@189.cn.""}, {'ForeName': 'Jiazeng', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': ""Department of General Surgery, The Affiliated Wuxi No. 2 People's Hospital of Nanjing Medical University, Jiangsu, PR China. Electronic address: xjz_wuxi@alumni.sjtu.edu.cn.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.031']
259,31785836,Thoracoscopic versus conventional open repair of tracheoesophageal fistula in neonates: A short-term comparative study.,"PURPOSE


Esophageal atresia with or without a tracheo-esophageal fistula is a challenging anomaly in neonates. Thoracoscopic repair is gaining popularity now in pediatric surgery community. The present study aims at comparing the short term outcomes of thoracoscopy versus classic thoracotomy for repair of such conditions.
METHODS


Thirty neonates with tracheoesophageal fistula were randomly divided into two equal groups (n=15) after excluding patients with birth weight <2000g, multiple associated anomalies and cardiorespiratory instability. One group had conventional open repair while the other had thoracoscopic repair. Demographic data, intraoperative result and post-operative findings were recorded and compared between both groups.
RESULTS


Both groups showed similar results regarding demographic and patients' characteristics. Thoracoscopic repair had relatively longer, yet non-significant operative time but with highly significant difference in preserving azygos vein. There was low conversion rate with thoracoscopy (6.66%). Open repair resulted in a longer hospital stay (11.73±5.68 vs 9.2±2.95). Complication rate was comparable in both groups; however, thoracoscopy was associated with better cosmetic results as reported by parents and surgeons (p=0.00).
CONCLUSION


Compared to thoracotomy, thoracoscopic repair offers a less invasive, effective and safe technique with similar short term outcomes, but with superior cosmetic results and better ability to spare azygos vein.
TYPE OF STUDY


Therapeutic/Treatment study LEVEL OF EVIDENCE: Level II.",2020,"Compared to thoracotomy, thoracoscopic repair offers a less invasive, effective and safe technique with similar short term outcomes, but with superior cosmetic results and better ability to spare azygos vein.
","['pediatric surgery community', 'Thirty neonates with tracheoesophageal fistula', 'neonates']","['Thoracoscopic versus conventional open repair of tracheoesophageal fistula', 'Thoracoscopic repair', 'thoracoscopy versus classic thoracotomy', 'conventional open repair while the other had thoracoscopic repair']","['longer hospital stay', 'low conversion rate', 'Demographic data, intraoperative result and post-operative findings', 'Complication rate']","[{'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0040588', 'cui_str': 'Esophagotracheal Fistula'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0472916', 'cui_str': 'TOF - Closure of tracheoesophageal fistula'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0039989', 'cui_str': 'Pleural Endoscopy'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.0768213,"Compared to thoracotomy, thoracoscopic repair offers a less invasive, effective and safe technique with similar short term outcomes, but with superior cosmetic results and better ability to spare azygos vein.
","[{'ForeName': 'Ahmed Ezzat', 'Initials': 'AE', 'LastName': 'Rozeik', 'Affiliation': 'Pediatric Surgery Department, Zagazig University Hospitals, Zagazig, Egypt.'}, {'ForeName': 'Mohamed Magdy', 'Initials': 'MM', 'LastName': 'Elbarbary', 'Affiliation': 'Pediatric Surgery Department, Cairo University Children Hospital (Abu El-Reesh), Cairo, Egypt.'}, {'ForeName': 'Amin Mohamed', 'Initials': 'AM', 'LastName': 'Saleh', 'Affiliation': 'Pediatric Surgery Department, Zagazig University Hospitals, Zagazig, Egypt.'}, {'ForeName': 'Ahmed Refaat', 'Initials': 'AR', 'LastName': 'Khodary', 'Affiliation': 'Pediatric Surgery Department, Zagazig University Hospitals, Zagazig, Egypt. Electronic address: ahmedrefaatkhodary@gmail.com.'}, {'ForeName': 'Mohammad Ahmad', 'Initials': 'MA', 'LastName': 'Al-Ekrashy', 'Affiliation': 'Pediatric Surgery Department, Zagazig University Hospitals, Zagazig, Egypt.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.09.040']
260,32144955,No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects.,"This thorough QT (TQT) study evaluated the effect of zanubrutinib on electrocardiogram (ECG) parameters by using concentration-QTc (C-QTc) analysis as the primary analysis for this study. Part A of the study determined the safety and tolerability of a single supratherapeutic dose of zanubrutinib (480 mg) in healthy volunteers. Part B was a randomized, blinded, placebo-controlled and positive-controlled, four-way crossover, TQT study of single therapeutic (160 mg) and supratherapeutic (480 mg) doses of zanubrutinib, placebo, and open-label moxifloxacin 400 mg. Thirty-two participants received at least 1 dose of zanubrutinib, and 26 participants completed all 4 periods. Zanubrutinib did not have any effect on heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology) and was generally well-tolerated. Using C-QTc analysis, the predicted placebo-corrected change-from-baseline QT interval using Fridericia's formula (ΔΔQTcF) was -3.4 msec (90% confidence interval: -4.9 to -1.9 msec) at peak concentrations of the 480 mg dose. A QT effect (ΔΔQTcF) exceeding 10 msec could be excluded within the observed concentration range at 160 and 480 mg doses. Assay sensitivity was established by moxifloxacin with 90% lower bound exceeding 5 msec. Implementing a C-QTc analysis prospectively in this TQT study resulted in a substantially smaller sample size to maintain a similar study power as shown in the traditional time-point analysis. A single 160-mg or 480-mg zanubrutinib dose did not prolong the QTc interval or have any other clinically relevant effects on ECG parameters.",2020,"Zanubrutinib did not have any effect on heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology) and was generally well tolerated.","['healthy volunteers', 'Healthy Subjects']","['moxifloxacin', 'single therapeutic (160-mg) and supratherapeutic (480-mg) doses of zanubrutinib, placebo, and open-label moxifloxacin', 'placebo']","['tolerated', 'safety and tolerability', 'Assay sensitivity', 'heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology', 'QTc interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction (observable entity)'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0429103', 'cui_str': 'T wave feature'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.159918,"Zanubrutinib did not have any effect on heart rate or cardiac conduction (pulse rate, QRS interval, or T-wave morphology) and was generally well tolerated.","[{'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Mu', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'eResearchTechnology, Inc. (ERT), Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Novotny', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Tawashi', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'eResearchTechnology, Inc. (ERT), Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Willett', 'Affiliation': 'Frontage Clinical Services, Inc., Secaucus, New Jersey, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Sahasranaman', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}, {'ForeName': 'Ying C', 'Initials': 'YC', 'LastName': 'Ou', 'Affiliation': 'BeiGene, Inc., San Mateo, California, USA.'}]",Clinical and translational science,['10.1111/cts.12779']
261,32215583,Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer.,"Importance


In men with recurrent prostate cancer, addition of long-term antiandrogen therapy to salvage radiotherapy (SRT) was associated with overall survival (OS) in the NRG/RTOG 9601 study. However, hormone therapy has associated morbidity, and there are no validated predictive biomarkers to identify which patients derive most benefit from treatment.
Objective


To examine the role of pre-SRT prostate-specific antigen (PSA) levels to personalize hormone therapy use with SRT.
Interventions


Men were randomized to SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo for 2 years.
Design, Setting, and Participants


In this secondary analysis of the multicenter RTOG 9601 double-blind, placebo-controlled randomized clinical trial conducted from 1998 to 2003 by a multinational cooperative group, men with a positive surgical margin or pathologic T3 disease after radical prostatectomy with pre-SRT PSA of 0.2 to 4.0 ng/mL were included. Analysis was performed between March 4, 2019, and December 20, 2019.
Main Outcomes and Measures


The primary outcome was overall survival (OS). Secondary end points included distant metastasis (DM), other-cause mortality (OCM), and grades 3 to 5 cardiac and neurologic toxic effects. Subgroup analyses were performed using the protocol-specified PSA stratification variable (1.5 ng/mL) and additional PSA cut points, including test for interaction. Competing risk analyses were performed for DM and other-cause mortality (OCM).
Results


Overall, 760 men with PSA elevation after radical prostatectomy for prostate cancer were included. The median (range) age of particpants was 65 (40-83) years. Antiandrogen assignment was associated with an OS benefit in the PSA stratum greater than 1.5 ng/mL (n = 118) with a 25% 12-year absolute benefit (hazard ratio [HR], 0.45; 95% CI, 0.25-0.81), but not in the PSA of 1.5 ng/mL or less stratum (n = 642) (1% 12-year absolute difference; HR, 0.87; 95% CI, 0.66-1.16). In a subanalysis of men with PSA of 0.61 to 1.5 (n = 253), there was an OS benefit associated with antiandrogen assignment (HR, 0.61; 95% CI, 0.39-0.94). In those receiving early SRT (PSA ≤0.6 ng/mL, n = 389), there was no improvement in OS (HR, 1.16; 95% CI, 0.79-1.70), an increased OCM hazard (subdistribution HR, 1.94; 95% CI, 1.17-3.20; P = .01), and an increased odds of late grades 3 to 5 cardiac and neurologic toxic effects (odds ratio, 3.57; 95% CI, 1.09-15.97; P = .05).
Conclusions and Relevance


These results suggest that pre-SRT PSA level may be a prognostic biomarker for outcomes of antiandrogen treatment with SRT. In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes. In men receiving early SRT (PSA ≤0.6 ng/mL), long-term antiandrogen treatment was not associated with improved OS. Future randomized clinical trials are needed to determine hormonal therapy benefit in this population.
Trial Registration


ClinicalTrials.gov Identifier: NCT00002874.",2020,"In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes.","['Interventions\n\n\nMen', 'Men With Prostate Cancer', '760 men with PSA elevation after radical prostatectomy for prostate cancer', 'men with recurrent prostate cancer, addition of long-term', '1998 to 2003 by a multinational cooperative group, men with a positive surgical margin or pathologic T3 disease after radical prostatectomy with pre-SRT PSA of 0.2 to 4.0 ng/mL were included']","['SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo', 'Long-term Antiandrogen Therapy', 'antiandrogen therapy to salvage radiotherapy (SRT', 'placebo']","['OS benefit', 'Presalvage Radiotherapy PSA Levels', 'distant metastasis (DM), other-cause mortality (OCM), and grades 3 to 5 cardiac and neurologic toxic effects', 'overall survival (OS', 'OCM hazard', 'neurologic toxic effects', 'OS', 'improved OS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1320169', 'cui_str': 'AntiAndrogens, Nonsteroidal'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",760.0,0.618209,"In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Dess', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Jackson', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Jairath', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Wallington', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Stish', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Zachery S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, West Hollywood, California.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Den', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Laila A', 'Initials': 'LA', 'LastName': 'Gharzai', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaworski', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Zachary R', 'Initials': 'ZR', 'LastName': 'Reichert', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Morgan', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Department of Pathology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Department of Medicine, Tulane Cancer Center, New Orleans, Louisiana.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William Robert', 'Initials': 'WR', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Duke Health, Durham, North Carolina.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, Sutter Medical Group, Sacramento, California.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Schipper', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zietman', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, West Hollywood, California.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0109']
262,32250418,Association Between Bedroom Particulate Matter Filtration and Changes in Airway Pathophysiology in Children With Asthma.,"Importance


Fine particles (particulate matter 2.5 μm [PM2.5]), a ubiquitous air pollutant, can deposit in the small airways that play a vital role in asthma. It appears to be unknown whether the use of a PM2.5 filtration device can improve small airway physiology and respiratory inflammation in children with asthma.
Objective


To discover what pathophysiological changes in the small airways are associated with using a PM2.5-removing device in the bedrooms of children with asthma.
Design, Setting, and Participants


Children with mild or moderate asthma were enrolled in this double-blind, crossover study. The participants used a true filtration device and a sham filtration device in their bedrooms in a random order for 2 weeks each with a 2-week washout interval. The study was conducted in a suburb of Shanghai, China, during a low-ozone season.
Exposures


Ozone and PM2.5 were measured inside bedrooms and outside a window.
Main Outcomes and Measures


Impulse oscillometry, spirometry, and fractional exhaled nitric oxide were measured at the beginning and the end of each intervention. Peak expiratory flow was measured twice daily at home.
Results


Forty-three children (5-13 years old; 26 boys [60%]) participated. Outdoor 24-hour mean PM2.5 concentrations were moderately high, ranging from 28.6 to 69.8 μg/m3 (median, 53 μg/m3). During true filtration, bedroom PM2.5 concentrations were a mean (SD) of 63.4% (35.9%) lower than during sham filtration. Compared with sham filtration, true filtration was significantly associated with improved airway mechanics, reflected in a 24.4% (95% CI, 11.8%-37.1%) reduction in total airway resistance, a 43.5% (95% CI, 13.7%-73.3%) reduction in small airway resistance, a 22.2% (95% CI, 2.2%-42.2%) reduction in resonant frequency, and a 73.1% (95% CI, 0.3%-145.8%) increase in airway reactance. True filtration was also associated with significant improvements in fractional exhaled nitric oxide (a 27.6% [95% CI, 8.9%-42.4%] reduction) and peak expiratory flow (a 1.6% [95% CI, 0.8%-2.5%] increase). These improvements were significantly associated with bedroom PM2.5 reduction. Improvements in small airway function were nonsignificant (8.4% [95% CI, -1.4% to 18.3%]) in all participants but significant (13.2% [95% CI, 1.2%-25.1%]) in participants without eosinophilic airway inflammation at baseline. No improvements were observed for forced vital capacity, forced expiratory volume during the first second, and the ratio of these in all participants or subgroups.
Conclusions and Relevance


Per these results, indoor PM2.5 filtration can be a practical method to improve air flow in an asthmatic lung through improved airway mechanics and function as well as reduced inflammation. This warrants a clinical trial to confirm.
Trial Registration


ClinicalTrials.gov Identifier: NCT03282864.",2020,"No improvements were observed for forced vital capacity, forced expiratory volume during the first second, and the ratio of these in all participants or subgroups.
","['Children With Asthma', 'children with asthma', 'Participants\n\n\nChildren with mild or moderate asthma', 'Results\n\n\nForty-three children (5-13 years old; 26 boys [60%]) participated', 'suburb of Shanghai, China, during a low-ozone season']","['Importance\n\n\nFine particles (particulate matter 2.5 μm [PM2.5', 'true filtration device and a sham filtration device', 'PM2.5 filtration device']","['fractional exhaled nitric oxide', 'small airway resistance', 'Measures\n\n\nImpulse oscillometry, spirometry, and fractional exhaled nitric oxide', 'airway reactance', 'Peak expiratory flow', 'airway mechanics', 'resonant frequency', 'total airway resistance', 'peak expiratory flow', 'forced vital capacity, forced expiratory volume', 'small airway function', 'Outdoor 24-hour mean PM2.5 concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0232024', 'cui_str': 'Total airway resistance'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",43.0,0.118197,"No improvements were observed for forced vital capacity, forced expiratory volume during the first second, and the ratio of these in all participants or subgroups.
","[{'ForeName': 'Xiaoxing', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Nicholas School of the Environment, Duke University, Durham, North Carolina.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'Global Health Research Center, Duke Kunshan University, Kunshan, Jiangsu Province, China.'}, {'ForeName': 'Karoline K', 'Initials': 'KK', 'LastName': 'Barkjohn', 'Affiliation': 'Department of Civil and Environmental Engineering, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Norris', 'Affiliation': 'Department of Civil and Environmental Engineering, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Department of Building Science, Tsinghua University, Beijing, China.'}, {'ForeName': 'Gina N', 'Initials': 'GN', 'LastName': 'Daniel', 'Affiliation': 'Nicholas School of the Environment, Duke University, Durham, North Carolina.'}, {'ForeName': 'Linchen', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Nicholas School of the Environment, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Pediatrics, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Drew B', 'Initials': 'DB', 'LastName': 'Day', 'Affiliation': 'Nicholas School of the Environment, Duke University, Durham, North Carolina.'}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Pediatrics, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jicheng', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Beijing Innovation Center for Engineering Science and Advanced Technology and State Key Joint Laboratory of Environment Simulation and Pollution Control, College of Environmental Sciences and Engineering, Peking University, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jinhan', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Department of Building Science, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yinping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Building Science, Tsinghua University, Beijing, China.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Schauer', 'Affiliation': 'Department of Civil and Environmental Engineering, College of Engineering, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Black', 'Affiliation': 'Underwriters Laboratories Inc, Marietta, Georgia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bergin', 'Affiliation': 'Department of Civil and Environmental Engineering, Duke University, Durham, North Carolina.'}, {'ForeName': 'Junfeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Nicholas School of the Environment, Duke University, Durham, North Carolina.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.0140']
263,31742631,Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine: The ACHIEVE II Randomized Clinical Trial.,"Importance


Ubrogepant is an oral calcitonin gene-related peptide receptor antagonist under investigation for acute treatment of migraine.
Objective


To evaluate the efficacy and tolerability of ubrogepant compared with placebo for acute treatment of a single migraine attack.
Design, Setting, and Participants


Phase 3, multicenter, randomized, double-blind, placebo-controlled, single-attack, clinical trial (ACHIEVE II) conducted in the United States (99 primary care and research clinics; August 26, 2016-February 26, 2018). Participants were adults with migraine with or without aura experiencing 2 to 8 migraine attacks per month.
Interventions


Ubrogepant 50 mg (n = 562), ubrogepant 25 mg (n = 561), or placebo (n = 563) for a migraine attack of moderate or severe pain intensity.
Main Outcomes and Measures


Co-primary efficacy outcomes were pain freedom and absence of the participant-designated most bothersome migraine-associated symptom (among photophobia, phonophobia, and nausea) at 2 hours after taking the medication.
Results


Among 1686 randomized participants, 1465 received study treatment (safety population; mean age, 41.5 years; 90% female); 1355 of 1465 (92.5%) were evaluable for efficacy. Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the ubrogepant 50-mg group, 90 of 435 (20.7%) in the ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 95% CI, 2.6%-12.5%; P = .01; 25 mg vs placebo, 6.4%; 95% CI, 1.5%-11.5%; P = .03). Absence of the most bothersome associated symptom at 2 hours was reported by 180 of 463 participants (38.9%) in the ubrogepant 50-mg group, 148 of 434 (34.1%) in the ubrogepant 25-mg group, and 125 of 456 (27.4%) in the placebo group (absolute difference for 50 mg vs placebo, 11.5%; 95% CI, 5.4%-17.5%; P = .01; 25 mg vs placebo, 6.7%; 95% CI, 0.6%-12.7%; P = .07). The most common adverse events within 48 hours of any dose were nausea (50 mg, 10 of 488 [2.0%]; 25 mg, 12 of 478 [2.5%]; and placebo, 10 of 499 [2.0%]) and dizziness (50 mg, 7 of 488 [1.4%]; 25 mg, 10 of 478 [2.1%]; placebo, 8 of 499 [1.6%]).
Conclusions and Relevance


Among adults with migraine, acute treatment with ubrogepant compared with placebo led to significantly greater rates of pain freedom at 2 hours with 50-mg and 25-mg doses, and absence of the most bothersome migraine-associated symptom at 2 hours only with the 50-mg dose. Further research is needed to assess the effectiveness of ubrogepant against other acute treatments for migraine and to evaluate the long-term safety of ubrogepant among unselected patient populations.
Trial Registration


ClinicalTrials.gov Identifier: NCT02867709.",2019,"Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the ubrogepant 50-mg group, 90 of 435 (20.7%) in the ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 95% CI, 2.6%-12.5%; P = .01; 25 mg vs placebo, 6.4%; 95% CI, 1.5%-11.5%; P = .03).","['adults with migraine', 'Acute Treatment of Migraine', 'Participants were adults with migraine with or without aura experiencing 2 to 8 migraine attacks per month', '1686 randomized participants, 1465 received study treatment (safety population; mean age, 41.5 years; 90% female); 1355 of 1465 (92.5%) were evaluable for efficacy', 'United States (99 primary care and research clinics']","['placebo', 'Ubrogepant vs Placebo']","['dizziness', 'rates of pain freedom', 'pain freedom and absence of the participant-designated most bothersome migraine-associated symptom (among photophobia, phonophobia, and nausea', 'Pain', 'efficacy and tolerability', 'nausea', 'Pain freedom']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085636', 'cui_str': 'Light Sensitivity'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1686.0,0.495495,"Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the ubrogepant 50-mg group, 90 of 435 (20.7%) in the ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 95% CI, 2.6%-12.5%; P = .01; 25 mg vs placebo, 6.4%; 95% CI, 1.5%-11.5%; P = .03).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Medstar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'Allergan plc, Madison, New Jersey.'}]",JAMA,['10.1001/jama.2019.16711']
264,31545048,Site-Specific Glycoprofiles of HDL-Associated ApoE are Correlated with HDL Functional Capacity and Unaffected by Short-Term Diet.,"Since high-density lipoprotein (HDL) glycoprofiles are associated with HDL functional capacity, we set out to determine whether diet can alter the glycoprofiles of key HDL-associated proteins, including ApoE, a potent driver of chronic disease risk. Ten healthy subjects consumed a fast food (FF) and a Mediterranean (Med) diet for 4 days in randomized order, with a 4-day wash-out between treatments. A multiple reaction monitoring method was used to characterize the site-specific glycoprofiles of HDL proteins, and HDL functional capacity was analyzed. We describe for the first time that ApoE has 7 mucin-type O-glycosylation sites, which were not affected by short-term diet. The glycoprofiles of other HDL-associated proteins were also unaffected, except that a disialylated ApoC-III glycan was enriched after Med diet, and a nonsialylated ApoC-III glycan was enriched after FF diet. Twenty-five individual glycopeptides were significantly correlated with cholesterol efflux capacity and 21 glycopeptides were correlated with immunomodulatory capacity. Results from this study indicate that the glycoprofiles of HDL-associated proteins including ApoE are correlated with HDL functional capacity but generally unaffected by diet in the short term, except ApoC-III sialylation. These results suggest that HDL protein glycoprofiles are affected by both acute and long-term factors and may be useful for biomarker discovery.",2019,Twenty-five individual glycopeptides were significantly correlated with cholesterol efflux capacity and 21 glycopeptides were correlated with immunomodulatory capacity.,['Ten healthy subjects'],['fast food (FF) and a Mediterranean (Med) diet'],"['HDL functional capacity', 'cholesterol efflux capacity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0344355', 'cui_str': 'Convenience Foods'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",10.0,0.0122588,Twenty-five individual glycopeptides were significantly correlated with cholesterol efflux capacity and 21 glycopeptides were correlated with immunomodulatory capacity.,"[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': ''}, {'ForeName': 'Qiongyu', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beals', 'Affiliation': ''}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'Rhodes', 'Affiliation': ''}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': ''}, {'ForeName': 'Carlito B', 'Initials': 'CB', 'LastName': 'Lebrilla', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': ''}]",Journal of proteome research,['10.1021/acs.jproteome.9b00450']
265,32267330,Effects of added salt reduction on central and peripheral blood pressure.,"BACKGROUND


Although the effects of salt intake reduction on casual blood pressure have been extensively studied in hypertensive individuals, data on reductions of added salt on arterial stiffness in both normotensive and prehypertensive subjects are scarce.
OBJECTIVE


To evaluate the effects of progressive reduction in added salt intake (from 6 grams to 4 grams per day) on peripheral and central blood pressure and arterial stiffness in normotensive, prehypertensive and hypertensive individuals.
METHODS


This was a single-blinded clinical trial with 13 weeks of follow-up. Normotensive (≤ 130/85 mmHg), prehypertensive (≥ 130 e < 139/≥ 85 e < 90 mmHg) and stage 1 hypertensive individuals (< 139/≥ 85 and < 90 mmHg) were assessed. Casual blood pressure measurements and ambulatory blood pressure monitoring were performed using the automated OMRON 705CP device, and central blood pressure was measured using the Sphygmocor®. Twenty-four-hour urinary sodium excretion and the amounts of added salt consumed were measured. Statistically significance level was set at p < 0.05 for all analysis.
RESULTS


A total of 55 participants (18 normotensive, 15 prehypertensive and 22 hypertensive), median age 48 years (IQR:39-54) were studied. The groups were not different in age or sex. No difference was observed in blood pressure or sodium excretion levels before and after the intervention. No significant changes in arterial stiffness parameters were observed.
CONCLUSION


The progressive reduction in added salt intake during a period of 13 weeks did not cause significant reductions in peripheral and central blood pressure. (Arq Bras Cardiol. 2020; 114(3):554-561).",2020,The progressive reduction in added salt intake during a period of 13 weeks did not cause significant reductions in peripheral and central blood pressure.,"['normotensive, prehypertensive and hypertensive individuals', 'hypertensive individuals', '130 e < 139/≥ 85 e < 90 mmHg) and stage 1 hypertensive individuals (< 139/≥ 85 and < 90 mmHg', 'Normotensive (≤ 130/85 mmHg), prehypertensive (≥', '55 participants (18 normotensive, 15 prehypertensive and 22 hypertensive), median age 48 years (IQR:39-54) were studied']","['salt intake reduction', 'added salt reduction']","['central and peripheral blood pressure', 'arterial stiffness parameters', 'Casual blood pressure measurements and ambulatory blood pressure monitoring', 'central blood pressure', 'blood pressure or sodium excretion levels', 'peripheral and central blood pressure and arterial stiffness', 'peripheral and central blood pressure', 'casual blood pressure']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",55.0,0.0274451,The progressive reduction in added salt intake during a period of 13 weeks did not cause significant reductions in peripheral and central blood pressure.,"[{'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Arantes', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Ana Luiza Lima', 'Initials': 'ALL', 'LastName': 'Sousa', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Priscila Valverde de O', 'Initials': 'PVO', 'LastName': 'Vitorino', 'Affiliation': 'Pontificia Universidade Católica de Goiás - Escola de Ciências Sociais e da Saúde - Mestrado em Atenção à Saúde, Goiânia, Goiás - Brasil.'}, {'ForeName': 'Paulo Cesar B Veiga', 'Initials': 'PCBV', 'LastName': 'Jardim', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Thiago de Souza Veiga', 'Initials': 'TSV', 'LastName': 'Jardim', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Jeeziane Marcelino', 'Initials': 'JM', 'LastName': 'Rezende', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Ellen de Souza', 'Initials': 'ES', 'LastName': 'Lelis', 'Affiliation': 'Pontificia Universidade Católica de Goiás - Escola de Ciências Sociais e da Saúde - Mestrado em Atenção à Saúde, Goiânia, Goiás - Brasil.'}, {'ForeName': 'Rafaela Bernardes', 'Initials': 'RB', 'LastName': 'Rodrigues', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Coca', 'Affiliation': 'Universitat de Barcelona, Barcelona - Espanha.'}, {'ForeName': 'Weimar Kunz Sebba', 'Initials': 'WKS', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal de Goiás - Faculdade de Medicina - Programa de Pós-Graduação em Ciências da Saúde, Goiânia, GO - Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180426']
266,32271354,Efficacy and Safety of Pembrolizumab Plus Docetaxel vs Docetaxel Alone in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer: The PROLUNG Phase 2 Randomized Clinical Trial.,"Importance


Because of socioeconomic factors, many patients with advanced non-small cell lung cancer (NSCLC) do not receive immunotherapy in the first-line setting. It is unknown if the combination of immunotherapy with chemotherapy can provide clinical benefits in immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy.
Objective


To evaluate the safety and efficacy of the combination of pembrolizumab plus docetaxel in patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status.
Design, Setting, and Participants


The Pembrolizumab Plus Docetaxel for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either pembrolizumab plus docetaxel or docetaxel alone from December 2016 through May 2019.
Interventions


The experimental arm received docetaxel on day 1 (75 mg/m2) plus pembrolizumab on day 8 (200 mg) every 3 weeks for up to 6 cycles followed by pembrolizumab maintenance until progression or unacceptable toxic effects. The control arm received docetaxel monotherapy.
Main Outcomes and Measures


The primary end point was overall response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival, and safety.
Results


Among 78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration. Forty patients were allocated to receive pembrolizumab plus docetaxel, and 38 were allocated to receive docetaxel. A statistically significant difference in ORR, assessed by an independent reviewer, was found in patients receiving pembrolizumab plus docetaxel vs patients receiving docetaxel (42.5% vs 15.8%; odds ratio, 3.94; 95% CI, 1.34-11.54; P = .01). Patients without EGFR variations had a considerable difference in ORR of 35.7% vs 12.0% (P = .06), whereas patients with EGFR variations had an ORR of 58.3% vs 23.1% (P = .14). Overall, PFS was longer in patients who received pembrolizumab plus docetaxel (9.5 months; 95% CI, 4.2-not reached) than in patients who received docetaxel (3.9 months; 95% CI, 3.2-5.7) (hazard ratio, 0.24; 95% CI, 0.13-0.46; P < .001). For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (P < .001), whereas in patients with EGFR variations, PFS was 6.8 months (95% CI, 6.2-not reached) vs 3.5 months (95% CI, 2.3-6.2) (P = .04). In terms of safety, 23% (9 of 40) vs 5% (2 of 38) of patients experienced grade 1 to 2 pneumonitis in the pembrolizumab plus docetaxel and docetaxel arms, respectively (P = .03), while 28% (11 of 40) vs 3% (1 of 38) experienced any-grade hypothyroidism (P = .002). No new safety signals were identified.
Conclusions and Relevance


In this phase 2 study, the combination of pembrolizumab plus docetaxel was well tolerated and substantially improved ORR and PFS in patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations.
Trial Registration


ClinicalTrials.gov Identifier: NCT02574598.",2020,"For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (","['patients with previously treated advanced NSCLC following platinum-based chemotherapy regardless of EGFR variants or programmed cell death ligand 1 status', 'Forty patients', 'patients with advanced NSCLC who had previous progression after platinum-based chemotherapy, including NSCLC with EGFR variations', 'for Advanced Non-Small Cell Lung Cancer (PROLUNG) trial randomized 78 patients with histologically confirmed advanced NSCLC in a 1:1 ratio to receive either', 'immunotherapy-naive patients with disease progression after treatment with platinum-based chemotherapy', '78 recruited patients, 32 (41%) were men, 34 (44%) were never smokers, and 25 (32%) had an EGFR/ALK alteration', 'Patients', 'patients with advanced non-small cell lung cancer (NSCLC', 'With Previously Treated Advanced Non-Small Cell Lung Cancer', 'alone from December 2016 through May 2019']","['immunotherapy with chemotherapy', 'Pembrolizumab Plus Docetaxel', 'docetaxel monotherapy', 'Pembrolizumab Plus Docetaxel vs Docetaxel Alone', 'pembrolizumab', 'pembrolizumab plus docetaxel or docetaxel', 'pembrolizumab plus docetaxel', 'pembrolizumab plus docetaxel and docetaxel', 'docetaxel']","['ORR', 'overall response rate (ORR', 'grade hypothyroidism', 'safety and efficacy', 'ORR and PFS', 'Overall, PFS', 'progression-free survival (PFS), overall survival, and safety', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",78.0,0.210182,"For patients without variations, PFS was 9.5 months (95% CI, 3.9-not reached) vs 4.1 months (95% CI, 3.5-5.3) (","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Feliciano', 'Initials': 'F', 'LastName': 'Barrón', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Laura Alejandra', 'Initials': 'LA', 'LastName': 'Ramírez-Tirado', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Zyanya Lucia', 'Initials': 'ZL', 'LastName': 'Zatarain-Barrón', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Cardona', 'Affiliation': 'Clinical and Translational Oncology Group, Clínica del Country, Bogotá, Colombia.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Díaz-García', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamamoto Ramos', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mota-Vega', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Carmona', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Marco Polo', 'Initials': 'MP', 'LastName': 'Peralta Álvarez', 'Affiliation': 'Thoracic Oncology Unit, Laboratory of Experimental Oncology, National Cancer Institute (INCan), Mexico City, Mexico.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Bautista', 'Affiliation': 'Hospital de Oncología, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Mexico City, Mexico.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aldaco', 'Affiliation': 'Servicio de Oncología Médica, Centro Médico Nacional 20 de Noviembre, Mexico City, Mexico.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gerson', 'Affiliation': 'Departamento de Oncología, Centro Médico ABC, Mexico City, Mexico.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rolfo', 'Affiliation': 'Thoracic Medical Oncology and Early Clinical Trials, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Molecular and Cellular Oncology Laboratory, Germans Trias i Pujol Research Institute and Hospital (IGTP), Barcelona, Spain.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0409']
267,32266500,Evaluation of low-volume post-dilution online hemodiafiltration with Japanese high-performance hemodiafilters.,"PURPOSE


To assess the removal performance of low-volume post-hemodiafiltration (HDF) with Japanese hemodiafilters and the removal performance with 20 % reduction in the total dialysate flow rate (Q d total).
METHODS


Subjects were 8 patients undergoing pre-HDF. Study 1: Post-HDF was performed at a blood flow rate (Q b ) of 250 mL/min and a total volume of substitution fluid (Vs) of 12 L/session(s) for 4 hrs using Fineflux-210Seco (FIX), ABH-21PA (ABH), and NVF-21H (NVF). We assessed removal efficiency of small molecular solutes, low-molecular-weight-proteins and the amount of albumin loss. Study 2: Post-HDF was performed at Vs of 12 L/s under G-1, Q d total of 500 and Q b  of 250 mL/min; G-2, Q d total of 400 and Q b  of 250 mL/min; and G-3, Q d total of 400 and Q b  of 300 mL/min. Removal efficiency was compared and analyzed between these conditions.
RESULTS


Study 1: The results using FIX, ABH and NVF are shown in order. The Kt/V were 1.8, 1.9 and 1.8. The β 2 -Microglobulin (MG) removal rate (RR) (%) were 81.2, 83.1 and 82.8, and the α 1 -MG RR were 37.4, 40.2 and 38.5, respectively. Study 2: The results in G-1, 2 and 3 are shown in order. The Kt/V and the RR of small solutes, were significantly higher in G-3. The β 2 -MG RR (%) were 81.2, 80.1 and 81.0, and the α 1 -MG RR were 37.4, 37.5 and 38.0, respectively.
CONCLUSIONS


Low-volume post-HDF performed at Q b  of 250 mL/min with Japanese high-performance hemodiafilters exhibited favorable removal efficiency for all solutes. Even with 20 % reduction in Q d total, the removal performance was also favorable.",2020,"The β 2 -Microglobulin (MG) removal rate (RR) (%) were 81.2, 83.1 and 82.8, and the α 1 -MG RR were 37.4, 40.2 and 38.5, respectively.",['with Japanese high-performance hemodiafilters'],"['low-volume post-hemodiafiltration (HDF', 'Japanese high-performance hemodiafilters', 'low-volume post-dilution online hemodiafiltration', 'Fineflux-210Seco (FIX), ABH-21PA (ABH), and NVF-21H (NVF']","['total dialysate flow rate (Q d total', 'removal performance', 'Removal efficiency', 'removal efficiency', 'Microglobulin\xa0(MG) removal rate (RR']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445431', 'cui_str': 'After the filter'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",8.0,0.0543162,"The β 2 -Microglobulin (MG) removal rate (RR) (%) were 81.2, 83.1 and 82.8, and the α 1 -MG RR were 37.4, 40.2 and 38.5, respectively.","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakurai', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan. ssakurai@peach.ocn.ne.jp.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Hosoya', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Fumi', 'Initials': 'F', 'LastName': 'Yamauchi', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Kurosawa', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Hashimoto Clinic, 3-21-5 Hashimoto Midori-ku, Sagamihara, Kanagawa, 252-0143, Japan. saito@hashicli.jp.'}]",Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs,['10.1007/s10047-020-01167-y']
268,31276804,Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial.,"BACKGROUND


Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care.
METHODS


Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models.
RESULTS


Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups.
CONCLUSIONS


The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.",2019,There were no between group and within group differences in percent of tacrolimus bioassays within target range (>50%).,"['Young adult heart transplant (HT) recipients transferring to adult care', 'young adults who underwent HT as children and transferred to adult care', 'Pediatric Heart Transplantation', 'Participants']","['Transitioning to Adult Care (TRANSIT', 'transition intervention (4 months long, focused on HT knowledge, self-care, self-advocacy, and social support) or usual care', 'transition intervention']","['average patient standard deviation of mean tacrolimus levels', 'tacrolimus bioassays', 'Average overall adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}]","[{'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0037438'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005507', 'cui_str': 'Biologic Assays'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.062108,There were no between group and within group differences in percent of tacrolimus bioassays within target range (>50%).,"[{'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: kgrady@nm.org.'}, {'ForeName': 'Adin-Cristian', 'Initials': 'AC', 'LastName': 'Andrei', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Shankel', 'Affiliation': ""Department of Medicine, Loma Linda University Children's Hospital, Loma Linda, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chinnock', 'Affiliation': ""Department of Medicine, Loma Linda University Children's Hospital, Loma Linda, CA.""}, {'ForeName': 'Shelley D', 'Initials': 'SD', 'LastName': 'Miyamoto', 'Affiliation': ""Department of Medicine, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amrut V', 'Initials': 'AV', 'LastName': 'Ambardekar', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Addonizio', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Latif', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Lefkowitz', 'Affiliation': ""Department of Psychiatry, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Lee R', 'Initials': 'LR', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Hollander', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pham', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""Van't Hof"", 'Affiliation': ""Department of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Weissberg-Benchell', 'Affiliation': ""Department of Psychiatry, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Clyde', 'Initials': 'C', 'LastName': 'Yancy', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Menghan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Melody', 'Affiliation': 'Pharmacy Department, Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Department of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.06.011']
269,32267771,The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design.,"There is broad interest in improved methods to generate robust evidence regarding best practice, especially in settings where patient conditions are heterogenous and require multiple concomitant therapies. Here, we present the rationale and design of a large, international trial that combines features of adaptive platform trials with pragmatic point-of-care trials to determine best treatment strategies for patients admitted to an intensive care unit with severe community-acquired pneumonia. The trial uses a novel design, entitled ""a randomized embedded multifactorial adaptive platform."" The design has five key features:  1 ) randomization, allowing robust causal inference;  2 ) embedding of study procedures into routine care processes, facilitating enrollment, trial efficiency, and generalizability;  3 ) a multifactorial statistical model comparing multiple interventions across multiple patient subgroups;  4 ) response-adaptive randomization with preferential assignment to those interventions that appear most favorable; and  5 ) a platform structured to permit continuous, potentially perpetual enrollment beyond the evaluation of the initial treatments. The trial randomizes patients to multiple interventions within four treatment domains: antibiotics, antiviral therapy for influenza, host immunomodulation with extended macrolide therapy, and alternative corticosteroid regimens, representing 240 treatment regimens. The trial generates estimates of superiority, inferiority, and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection. The trial will also compare ventilatory and oxygenation strategies, and has capacity to address additional questions rapidly during pandemic respiratory infections. As of January 2020, REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) was approved and enrolling patients in 52 intensive care units in 13 countries on 3 continents. In February, it transitioned into pandemic mode with several design adaptations for coronavirus disease 2019. Lessons learned from the design and conduct of this trial should aid in dissemination of similar platform initiatives in other disease areas.Clinical trial registered with www.clinicaltrials.gov (NCT02735707).",2020,"The trial generates estimates of superiority, inferiority and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection.","['multiple patient subgroups', 'Community-acquired Pneumonia (REMAP-CAP', 'patients admitted to an intensive care unit with severe community-acquired pneumonia (CAP']","['antibiotics, antiviral therapy for influenza, host immunomodulation with extended macrolide therapy, and alternative corticosteroid regimens']","['90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C1963758', 'cui_str': 'Immunomodulatory therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.108372,"The trial generates estimates of superiority, inferiority and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection.","[{'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Al-Beidh', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum-Puijk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bhimani', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Clinical Studies and Center for Sepsis Control and Care, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Chiche', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Cochin, Paris Descartes University, Paris, France.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'De Jong', 'Affiliation': 'Department of Medical Microbiology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Microbiology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alisa M', 'Initials': 'AM', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'Hullegie', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kruger', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'University of British Columbia School of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Genevieve K', 'Initials': 'GK', 'LastName': ""O'Neill"", 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Rohde', 'Affiliation': 'Department of Respiratory Medicine, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Lennie', 'Initials': 'L', 'LastName': 'Derde', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202003-192SD']
270,32270683,Impact of a Palliative Care Education Module in Patients With Heart Failure.,"BACKGROUND


Heart failure (HF) impacts 6.2 million American adults. With no cure, therapies aim to prevent progression and manage symptoms. Inclusion of palliative care (PC) helps improve symptoms and quality of life. Heart failure guidelines recommend the inclusion of PC in HF therapy, but referrals are often delayed.
OBJECTIVE


Introduce PC to patients with HF and examine the impact on PC consults, readmission, mortality, and intensive care unit (ICU) transfers.
METHODS


Patients (n = 60) admitted with HF to an academic hospital were asked to view a PC educational module. A number of PC consults, re-admissions, mortality, and transfers to the ICU were compared among participants and those who declined.
RESULTS


Nine patients in the intervention group (n = 30) requested a PC consult ( P  = .042) versus 2 in the usual care group (n = 30;  P  = .302). There was no statistically significant difference in readmissions, mortality, or ICU transfers between groups.
CONCLUSIONS


Palliative care education increases the likelihood of PC utilization but in this short-term project was not found to statistically impact mortality, re-admissions, or transfers to higher levels of care.",2020,"RESULTS


Nine patients in the intervention group (n = 30) requested a PC consult ( P  = .042) versus 2 in the usual care group (n = 30;  P  = .302).","['Patients (n = 60) admitted with HF to an academic hospital were asked to view a PC educational module', 'Heart failure (HF) impacts 6.2 million American adults', 'Patients With Heart Failure']","['palliative care (PC', 'Palliative Care Education Module']","['PC consults, readmission, mortality, and intensive care unit (ICU) transfers', 'number of PC consults, re-admissions, mortality, and transfers to the ICU', 'symptoms and quality of life', 'readmissions, mortality, or ICU transfers', 'likelihood of PC utilization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C3266593', 'cui_str': 'Palliative care education'}, {'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",60.0,0.0486216,"RESULTS


Nine patients in the intervention group (n = 30) requested a PC consult ( P  = .042) versus 2 in the usual care group (n = 30;  P  = .302).","[{'ForeName': 'Shelley L', 'Initials': 'SL', 'LastName': 'Thompson', 'Affiliation': '213852Duke University Hospital, Durham, NC, USA.'}, {'ForeName': 'Cary', 'Initials': 'C', 'LastName': 'Ward', 'Affiliation': '213852Duke University Hospital, Durham, NC, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Galanos', 'Affiliation': '213852Duke University Hospital, Durham, NC, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bowers', 'Affiliation': '213852Duke University Hospital, Durham, NC, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909120918524']
271,32168216,Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor.
METHODS


We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage of labor. All participating women had the cephalic elevation device inserted by the delivering provider and were randomly allocated to inflation or noninflation of the device. Inflation was performed in a blinded fashion. The primary outcome was time from hysterotomy to delivery. A sample size of 30 per group (N=60 participants) was planned to detect a 50% decrease in time to delivery after hysterotomy with cephalic elevation device inflation.
RESULTS


From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized. Analysis was by intention to treat. Women in the inflation group were older (33 vs 30.5 years), but the groups were otherwise similar. In both groups, most women had a low-transverse hysterotomy (93%). The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01). There was no significant difference in neonatal outcomes.
CONCLUSION


Use of the cephalic elevation device during second-stage cesarean delivery led to a 23-second reduction time from hysterotomy to delivery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03342508.
FUNDING SOURCE


The cephalic elevation devices used in this study were donated by Safe Obstetrics Systems.",2020,The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01).,"['cesarean deliveries during the second stage of labor', 'All participating women had the cephalic elevation device inserted by the delivering provider', 'Women were eligible if they were to undergo cesarean delivery in the second stage of labor', 'nulliparous, term women aged 18-50 years with vertex singleton pregnancies', 'From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized']",['Cephalic Elevation Device'],"['time from hysterotomy to delivery', 'median time from hysterotomy to delivery', 'neonatal outcomes']","[{'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]","[{'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020711', 'cui_str': 'Hysterotomy'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",60.0,0.467182,The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01).,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Lassey', 'Affiliation': ""Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Little', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saadeh', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Patton', 'Affiliation': ''}, {'ForeName': 'Michaela K', 'Initials': 'MK', 'LastName': 'Farber', 'Affiliation': ''}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Bateman', 'Affiliation': ''}, {'ForeName': 'Julian N', 'Initials': 'JN', 'LastName': 'Robinson', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003746']
272,31895437,Cortical Connectivity Moderators of Antidepressant vs Placebo Treatment Response in Major Depressive Disorder: Secondary Analysis of a Randomized Clinical Trial.,"Importance


Despite the widespread awareness of functional magnetic resonance imaging findings suggesting a role for cortical connectivity networks in treatment selection for major depressive disorder, its clinical utility remains limited. Recent methodological advances have revealed functional magnetic resonance imaging-like connectivity networks using electroencephalography (EEG), a tool more easily implemented in clinical practice.
Objective


To determine whether EEG connectivity could reveal neural moderators of antidepressant treatment.
Design, Setting, and Participants


In this nonprespecified secondary analysis, data were analyzed from the Establishing Moderators and Biosignatures of Antidepressant Response in Clinic Care study, a placebo-controlled, double-blinded randomized clinical trial. Recruitment began July 29, 2011, and was completed December 15, 2015. A random sample of 221 outpatients with depression aged 18 to 65 years who were not taking medication for depression was recruited and assessed at 4 clinical sites. Analysis was performed on an intent-to-treat basis. Statistical analysis was performed from November 16, 2018, to May 23, 2019.
Interventions


Patients received either the selective serotonin reuptake inhibitor sertraline hydrochloride or placebo for 8 weeks.
Main Outcomes and Measures


Electroencephalographic orthogonalized power envelope connectivity analyses were applied to resting-state EEG data. Intent-to-treat prediction linear mixed models were used to determine which pretreatment connectivity patterns were associated with response to sertraline vs placebo. The primary clinical outcome was the total score on the 17-item Hamilton Rating Scale for Depression, administered at each study visit.
Results


Of the participants recruited, 9 withdrew after first dose owing to reported adverse effects, and 221 participants (150 women; mean [SD] age, 37.8 [12.7] years) underwent EEG recordings and had high-quality pretreatment EEG data. After correction for multiple comparisons, connectome-wide analyses revealed moderation by connections within and between widespread cortical regions-most prominently parietal-for both the antidepressant and placebo groups. Greater alpha-band and lower gamma-band connectivity predicted better placebo outcomes and worse antidepressant outcomes. Lower connectivity levels in these moderating connections were associated with higher levels of anhedonia. Connectivity features that moderate treatment response differentially by treatment group were distinct from connectivity features that change from baseline to 1 week into treatment. The group mean (SD) score on the 17-item Hamilton Rating Scale for Depression was 18.35 (4.58) at baseline and 26.14 (30.37) across all time points.
Conclusions and Relevance


These findings establish the utility of EEG-based network functional connectivity analyses for differentiating between responses to an antidepressant vs placebo. A role emerged for parietal cortical regions in predicting placebo outcome. From a treatment perspective, capitalizing on the therapeutic components leading to placebo response differentially from antidepressant response should provide an alternative direction toward establishing a placebo signature in clinical trials, thereby enhancing the signal detection in randomized clinical trials.
Trial Registration


ClinicalTrials.gov identifier: NCT01407094.",2020,Connectivity features that moderate treatment response differentially by treatment group were distinct from connectivity features that change from baseline to 1 week into treatment.,"['221 participants (150 women; mean [SD] age, 37.8 [12.7] years) underwent EEG recordings and had high-quality pretreatment EEG data', '221 outpatients with depression aged 18 to 65 years who were not taking medication for depression was recruited and assessed at 4 clinical sites', 'Major Depressive Disorder']","['electroencephalography (EEG', 'selective serotonin reuptake inhibitor sertraline hydrochloride or placebo', 'Antidepressant vs Placebo', 'sertraline vs placebo', 'placebo']","['total score on the 17-item Hamilton Rating Scale for Depression', 'anhedonia', 'mean (SD) score on the 17-item Hamilton Rating Scale for Depression', 'Greater alpha-band and lower gamma-band connectivity']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1290952', 'cui_str': 'Taking medication (observable entity)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0600526', 'cui_str': 'Sertraline Hydrochloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]",221.0,0.570561,Connectivity features that moderate treatment response differentially by treatment group were distinct from connectivity features that change from baseline to 1 week into treatment.,"[{'ForeName': 'Camarin E', 'Initials': 'CE', 'LastName': 'Rolle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Toll', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3867']
273,32259016,Diabetes and Clinical Outcome in Patients With Metastatic Colorectal Cancer: CALGB 80405 (Alliance).,"Background


Diabetes is a prognostic factor for some malignancies, but its association with outcome in patients with advanced or metastatic colorectal cancer (CRC) is less clear.
Methods


This cohort study was nested within a randomized trial of first-line chemotherapy and bevacizumab and/or cetuximab for advanced or metastatic CRC. Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network. The primary exposure was physician-documented diabetes at the time of enrollment. The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events. Tests of statistical significance were two-sided.
Results


Among 2326 patients, 378 (16.3%) had diabetes. The median follow-up time was 6.0 years. We observed 1973 OS events and 2173 PFS events. The median time to an OS event was 22.7 months among those with diabetes and 27.1 months among those without diabetes (HR = 1.27, 95% CI = 1.13 to 1.44;  P  <   .001). The median time to a PFS event was 9.7 months among those with diabetes and 10.8 months among those without diabetes (HR = 1.16, 95% CI = 1.03 to 1.30;  P  =   .02). Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
Conclusions


Diabetes is associated with an increased risk of mortality and tumor progression in patients with advanced or metastatic CRC. Patients with diabetes tolerate first-line treatment with chemotherapy and monoclonal antibodies similarly to patients without diabetes.",2020,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","['Patients were enrolled at 508 community and academic centers throughout the National Clinical Trials Network', 'Patients with diabetes tolerate first-line treatment with', 'patients with advanced or metastatic colorectal cancer (CRC', 'advanced or metastatic CRC', 'Patients', '2326 patients, 378 (16.3%) had diabetes', 'patients with advanced or metastatic CRC']","['bevacizumab and/or cetuximab', 'chemotherapy and monoclonal antibodies']","['physician-documented diabetes', 'overall survival (OS); secondary endpoints were progression-free survival (PFS) and adverse events', 'median time to a PFS event', 'median time to an OS event', 'grade 3 hypertension', 'adverse events, including neuropathy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",2326.0,0.0321453,"Patients with diabetes were more likely to experience no less than grade 3 hypertension (8.1% vs 4.4%;  P  =   .054) but were not more likely to experience other adverse events, including neuropathy.
","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Blase N', 'Initials': 'BN', 'LastName': 'Polite', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Denlinger', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': ""See the Notes section for the full list of authors' affiliations.""}]",JNCI cancer spectrum,['10.1093/jncics/pkz078']
274,32078683,Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.,"Importance


Intravenous thrombolysis with tenecteplase improves reperfusion prior to endovascular thrombectomy for ischemic stroke compared with alteplase.
Objective


To determine whether 0.40 mg/kg of tenecteplase safely improves reperfusion before endovascular thrombectomy vs 0.25 mg/kg of tenecteplase in patients with large vessel occlusion ischemic stroke.
Design, Setting, and Participants


Randomized clinical trial at 27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes. Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019. Adult patients (N = 300) with ischemic stroke due to occlusion of the intracranial internal carotid, \basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria.
Interventions


Open-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n = 150) or 0.25 mg/kg (maximum, 25 mg; n = 150) given as a bolus before endovascular thrombectomy.
Main Outcomes and Measures


The primary outcome was reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy, assessed by consensus of 2 blinded neuroradiologists. Prespecified secondary outcomes were level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement at 3 days; symptomatic intracranial hemorrhage within 36 hours; and all-cause death.
Results


All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial. The number of participants with greater than 50% reperfusion of the previously occluded vascular territory was 29 of 150 (19.3%) in the 0.40 mg/kg group vs 29 of 150 (19.3%) in the 0.25 mg/kg group (unadjusted risk difference, 0.0% [95% CI, -8.9% to -8.9%]; adjusted risk ratio, 1.03 [95% CI, 0.66-1.61]; P = .89). Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
Conclusions and Relevance


Among patients with large vessel occlusion ischemic stroke, a dose of 0.40 mg/kg, compared with 0.25 mg/kg, of tenecteplase did not significantly improve cerebral reperfusion prior to endovascular thrombectomy. The findings suggest that the 0.40-mg/kg dose of tenecteplase does not confer an advantage over the 0.25-mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT03340493.",2020,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","['Adult patients (N\u2009=\u2009300) with ischemic stroke due to occlusion of the intracranial internal carotid, \\basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria', 'All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial', 'Patients With Large Vessel Occlusion Ischemic Stroke', 'Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019', '27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes', 'patients with large vessel occlusion ischemic stroke']","['Interventions\n\n\nOpen-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n\u2009=\u2009150) or 0.25 mg/kg']","['Cerebral Reperfusion', 'occluded vascular territory', 'cause deaths', 'symptomatic intracranial hemorrhage', 'cerebral reperfusion', '4 functional outcomes', 'reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy', 'level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.594367,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","[{'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Bush', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scroop', 'Affiliation': 'Department of Radiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Neurology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Darshan G', 'Initials': 'DG', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Melbourne Medical School, Department of Medicine and Neurology, The University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Fana', 'Initials': 'F', 'LastName': 'Alemseged', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'de Villiers', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Philip M C', 'Initials': 'PMC', 'LastName': 'Choi', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leggett', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Collecutt', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cordato', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clissold', 'Affiliation': 'Department of Neurology, University Hospital Geelong, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Miteff', 'Affiliation': 'Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Clissold', 'Affiliation': 'Department of Medicine, Southwest Healthcare, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Prahran, Victoria, Australia.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Bolitho', 'Affiliation': 'Department of Medicine, Northeast Health, Wangaratta, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bonavia', 'Affiliation': 'Department of Medicine, Albury Base Hospital, Albury, New South Wales, Australia.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Medicine, Goulburn Valley Health, Shepparton, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Latrobe Regional Health, Traralgon, Victoria, Australia.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Department of Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Fintan', 'Initials': 'F', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wong', 'Affiliation': ""Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Maridulu budyari gumal, The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1511']
275,31279675,Aerobic Plus Resistance Exercise in Obese Older Adults Improves Muscle Protein Synthesis and Preserves Myocellular Quality Despite Weight Loss.,"Anabolic resistance and impaired myocellular quality contribute to age-related sarcopenia, which exacerbates with obesity. Diet-induced muscle mass loss is attenuated by resistance or aerobic plus resistance exercise compared to aerobic exercise in obese elderly. We assessed chronic effects of weight loss plus different exercise modalities on muscle protein synthesis response to feeding and myocellular quality. Obese older adults were randomized to a weight-management program plus aerobic, resistance, or combined aerobic and resistance exercise or to control. Participants underwent vastus lateralis biopsies at baseline and 6 months. Muscle protein synthesis rate increased more in resistance and combined than in control. Autophagy mediators' expression decreased more in combined than in aerobic, which experienced a higher increase in inflammation and mitochondrial regulators' expression. In obese elderly, combined aerobic and resistance exercise is superior to either mode independently for improving muscle protein synthesis and myocellular quality, thereby maintaining muscle mass during weight-loss therapy.",2019,"In obese elderly, combined aerobic and resistance exercise is superior to either mode independently for improving muscle protein synthesis and myocellular quality, thereby maintaining muscle mass during weight-loss therapy.","['Obese older adults', 'obese elderly', 'Obese Older Adults']","['Aerobic Plus Resistance Exercise', 'weight loss plus different exercise modalities', 'weight-management program plus aerobic, resistance, or combined aerobic and resistance exercise or to control', 'aerobic exercise', 'aerobic plus resistance exercise']","[""inflammation and mitochondrial regulators' expression"", 'Muscle protein synthesis rate', 'Muscle Protein Synthesis and Preserves Myocellular Quality', ""Autophagy mediators' expression"", 'Anabolic resistance']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}]",,0.0167948,"In obese elderly, combined aerobic and resistance exercise is superior to either mode independently for improving muscle protein synthesis and myocellular quality, thereby maintaining muscle mass during weight-loss therapy.","[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Colleluori', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA; Center for Translational Research on Inflammatory Diseases (CTRID), Michael E. DeBakey VA Medical Center, Houston, TX 77030, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aguirre', 'Affiliation': 'Medical Care Line, New Mexico VA Health Care System and Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM 87108 USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Phadnis', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA; Center for Translational Research on Inflammatory Diseases (CTRID), Michael E. DeBakey VA Medical Center, Houston, TX 77030, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Fowler', 'Affiliation': 'Medical Care Line, New Mexico VA Health Care System and Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM 87108 USA.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA; Center for Translational Research on Inflammatory Diseases (CTRID), Michael E. DeBakey VA Medical Center, Houston, TX 77030, USA.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Brunetti', 'Affiliation': 'Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hyoung Park', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Benny Abraham', 'Initials': 'BA', 'LastName': 'Kaipparettu', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Nagireddy', 'Initials': 'N', 'LastName': 'Putluri', 'Affiliation': 'Department of Molecular and Cellular Biology, Baylor College of Medicine, Houston, TX 77030, USA; Advanced Technology Core, Baylor College of Medicine, Houston, TX 77030, USA.'}, {'ForeName': 'Vimlin', 'Initials': 'V', 'LastName': 'Auetumrongsawat', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA; Center for Translational Research on Inflammatory Diseases (CTRID), Michael E. DeBakey VA Medical Center, Houston, TX 77030, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Yarasheski', 'Affiliation': 'Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes, Washington University School of Medicine, St. Louis, MO 63110, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Department of Mathematics and Statistics and School of Medicine, University of New Mexico School of Medicine, Albuquerque, NM 87108 USA.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX 77030, USA; Center for Translational Research on Inflammatory Diseases (CTRID), Michael E. DeBakey VA Medical Center, Houston, TX 77030, USA. Electronic address: dennis.villareal@bcm.edu.'}]",Cell metabolism,['10.1016/j.cmet.2019.06.008']
276,31748227,"Antigenic competition in CD4 +  T cell responses in a randomized, multicenter, double-blind clinical HIV vaccine trial.","T cell responses have been implicated in reduced risk of HIV acquisition in uninfected persons and control of viral replication in HIV-infected individuals. HIV Gag-specific T cells have been predominantly associated with post-infection control, whereas Env antigens are the target for protective antibodies; therefore, inclusion of both antigens is common in HIV vaccine design. However, inclusion of multiple antigens may provoke antigenic competition, reducing the potential effectiveness of the vaccine. HVTN 084 was a randomized, multicenter, double-blind phase 1 trial to investigate whether adding Env to a Gag/Pol vaccine decreases the magnitude or breadth of Gag/Pol-specific T cell responses. Fifty volunteers each received one intramuscular injection of 1 × 10 10  particle units (PU) of rAd5 Gag/Pol and EnvA/B/C (3:1:1:1 mixture) or 5 × 10 9  PU of rAd5 Gag/Pol. CD4 +  T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8 +  T cell responses did not differ significantly between the two groups. Mapping of individual epitopes revealed greater breadth of the Gag/Pol-specific T cell response in the absence of Env compared to Env coimmunization. Addition of an Env component to a Gag/Pol vaccine led to reduced Gag/Pol CD4 +  T cell response rate and magnitude as well as reduced epitope breadth, confirming the presence of antigenic competition. Therefore, T cell-based vaccine strategies should aim at choosing a minimalist set of antigens to reduce interference of individual vaccine components with the induction of the maximally achievable immune response.",2019,"CD4 +  T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8 +  T cell responses did not differ significantly between the two groups.",['Fifty volunteers each received one'],['intramuscular injection of 1 × 10 10  particle units (PU) of rAd5 Gag/Pol and EnvA/B/C (3:1:1:1 mixture) or 5 × 10 9  PU of rAd5 Gag/Pol'],"['Gag/Pol CD4 +  T cell response rate', 'CD8 +  T cell responses', 'breadth of the Gag/Pol-specific T cell response', 'magnitude or breadth of Gag/Pol-specific T cell responses', 'CD4 +  T cell responses', 'cytokine expression']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}]","[{'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",50.0,0.193547,"CD4 +  T cell responses to Gag/Pol measured 4 weeks after vaccination by cytokine expression were significantly higher in the group vaccinated without Env, whereas CD8 +  T cell responses did not differ significantly between the two groups.","[{'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Division of Clinical Immunology and Allergy, University of São Paulo, São Paulo 05508, Brazil.'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Grunenberg', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Chenchen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Manso', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Division of Immunology and Allergy, Lausanne University Hospital (CHUV), 1011 Lausanne, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Casapia', 'Affiliation': 'Asociación Civil Selva Amazónica, Iquitos 16002, Peru.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valencia', 'Affiliation': 'Asociación Civil Impacta Salud Y Educación, Lima 15063, Peru.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Sobieszczyk', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY 10025, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Van Tieu', 'Affiliation': 'Laboratory of Infectious Disease Prevention, New York Blood Center, New York, NY 10065, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Division of AIDS, National Institute for Allergy and Infectious Diseases, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hural', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Barney S', 'Initials': 'BS', 'LastName': 'Graham', 'Affiliation': 'Vaccine Research Center, NIH, Bethesda, MD 20892, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kublin', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Gilbert', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Corey', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Goepfert', 'Affiliation': 'Division of Infectious Disease and Department of Surgery, Division of Gastroenterology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL 35294, USA.'}, {'ForeName': 'M Juliana', 'Initials': 'MJ', 'LastName': 'McElrath', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Johnson', 'Affiliation': 'Yerkes National Primate Research Center, School of Medicine, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Yunda', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. nicole.frahm@gatesmri.org.'}]",Science translational medicine,['10.1126/scitranslmed.aaw1673']
277,32265094,"Digital Monitoring of Sleep, Meals, and Physical Activity for Reducing Depression in Older Spousally-Bereaved Adults: A Pilot Randomized Controlled Trial.","OBJECTIVES


To evaluate the feasibility and acceptability of a behavioral intervention and explore its impact on depression symptom burden among older spousally-bereaved adults.
METHODS


Participants were age ≥60 years, bereaved ≤8 months, and at high risk for depression. Participants were randomized to 12 weeks of digital monitoring of sleep, meals, and physical activity; digital monitoring plus health coaching; or enhanced usual care and followed for 9 months for new-episode depression.
RESULTS


We enrolled 57 participants, 85% of eligible adults and 38% of all adults screened. We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained. In linear mixed-effects models, depression symptoms significantly decreased, but the interaction between time and intervention was not significant.
CONCLUSION


A behavioral intervention that uses both digital monitoring and motivational health coaching is feasible and acceptable to older bereaved adults.",2020,We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained.,"['We enrolled 57 participants, 85% of eligible adults and 38% of all adults screened', 'older bereaved adults', 'Participants were age ≥60 years, bereaved ≤8 months, and at high risk for depression', 'Older Spousally-Bereaved Adults', 'older spousally-bereaved adults']","['behavioral intervention', 'digital monitoring and motivational health coaching', 'digital monitoring of sleep, meals, and physical activity; digital monitoring plus health coaching; or enhanced usual care', 'Digital Monitoring of Sleep, Meals, and Physical Activity']","['depression symptoms', 'depression symptom burden']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",57.0,0.0537475,We observed high levels of adherence in both digital monitoring (90%) and health coaching (92%); 88% of participants were retained.,"[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA. Electronic address: Sarah.Stahl@pitt.edu.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Smagula', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Mary Amanda', 'Initials': 'MA', 'LastName': 'Dew', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schulz', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA; University Center for Social and Urban Research, Pittsburgh, PA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Albert', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh (SMA), Pittsburgh, PA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry (STS, SFS, MAD, RS, CFR), University of Pittsburgh, Pittsburgh, PA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.02.013']
278,30664008,"Interferon-α versus interleukin-2 in Chinese patients with malignant melanoma: a randomized, controlled, trial.","The US Food and Drug Association has approved interferon-α (IFN-α) and interleukin-2 (IL-2) as adjuvant therapy in malignant melanoma. The objective of the study was to compare efficacy and safety of subcutaneous interferon-α with continuous intravenous IL-2 in Chinese patients with malignant melanoma. A total of 250 patients with unresectable malignant melanoma were subjected to randomized in 1 : 1 ratio. Patients received subcutaneous 9×10 IU/m IFN-α (IFN-α group, n=125) or continuous intravenous 9×10 IU/m IL-2 (IL-2 group, n=125) at every 21 days for 4 months. The response, progression-free survival, overall survival, adverse effects, and cost were evaluated by experts in the field. IL-2 and IFN-α were effective in improvement of malignant melanoma after 4 months of intervention. IL-2 was effective in improving brain metastasis. Patients of the IL-2 group had a higher overall survival (P<0.0001) and a higher progression-free survival (P=0.002) than those of IFN-α group. The IL-2 group reported hypotension, kidney dysfunction, liver dysfunctions, flu-like symptoms, and capillary leak syndrome as adverse effects. IFN-α group reported thrombocytopenia and neutropenia as adverse effects. Healthcare management and expert charges lead to increase in the cost of treatment for IL-2 group patients than IFN-α group (P<0.0001). Continuous intravenous IL-2 should be recommended in relapse-free Chinese patients with malignant melanoma. Level of Evidence: I.",2019,Healthcare management and expert charges lead to increase in the cost of treatment for IL-2 group patients than IFN-α group (P<0.0001).,"['250 patients with unresectable malignant melanoma', 'Chinese patients with malignant melanoma']","['IFN-α', 'subcutaneous interferon-α', 'subcutaneous 9×10\u2009IU/m IFN-α (IFN-α group, n=125) or continuous intravenous 9×10\u2009IU/m IL-2 (IL-2', 'IL-2 and IFN-α', 'IL-2', 'Interferon-α versus interleukin-2']","['brain metastasis', 'higher progression-free survival', 'response, progression-free survival, overall survival, adverse effects, and cost', 'hypotension, kidney dysfunction, liver dysfunctions, flu-like symptoms, and capillary leak syndrome', 'efficacy and safety', 'overall survival', 'thrombocytopenia and neutropenia']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}]","[{'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0151746', 'cui_str': 'Abnormal renal function (finding)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms (finding)'}, {'cui': 'C0343084', 'cui_str': 'Clarkson Disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",250.0,0.635947,Healthcare management and expert charges lead to increase in the cost of treatment for IL-2 group patients than IFN-α group (P<0.0001).,"[{'ForeName': 'Shenglong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.'}, {'ForeName': 'Xixi', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'School of Medicine, Ross University School of Medicine, Miramar, Florida, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'The Graduate School, China Medical University, Shenyang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Pei', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zheng', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.'}, {'ForeName': 'Enduo', 'Initials': 'E', 'LastName': 'Qiu', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Bone and Soft Tissue Tumor Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000741']
279,31483448,Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial.,"Importance


The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear.
Objective


To define patterns of recurrence after adjuvant chemotherapy and the association with survival.
Design, Setting, and Participants


Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019.
Interventions


Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine.
Main Outcomes and Measures


Overall survival, recurrence, and sites of recurrence.
Results


Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 and P = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .03).
Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection.
Trial Registration


ClinicalTrials.gov identifier: NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.",2019,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[' median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43', '730 patients who had resection and adjuvant chemotherapy for pancreatic cancer', 'Pancreatic Ductal Adenocarcinoma', '730 patients']","['Gemcitabine plus capecitabine', 'gemcitabine', 'gemcitabine or gemcitabine plus capecitabine']","['local recurrence', 'median overall survival', 'Measures\n\n\nOverall survival, recurrence, and sites of recurrence', 'overall survival', 'median survival', 'death following recurrence', 'local with distant recurrence', 'time to recurrence and subsequent and overall survival', 'Recurrence', 'distant recurrence', 'median follow-up time', 'Local recurrence', '5-year survival estimates']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",730.0,0.440122,"Conclusions and Relevance


There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Jones', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Eftychia-Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ghaneh', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Halloran', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester/The Christie, Manchester, England.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, England.'}, {'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester University Foundation Trust, Manchester, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, England.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Roopinder', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospital, Leeds, England.""}, {'ForeName': 'Pehr', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, England.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Izbicki', 'Affiliation': 'University of Hamburg Medical Institutions UKE, Hamburg, Germany.'}, {'ForeName': 'Gary William', 'Initials': 'GW', 'LastName': 'Middleton', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Guy's Hospital, London, England.""}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, London, England.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Yuk', 'Initials': 'Y', 'LastName': 'Ting', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, England.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sherriff', 'Affiliation': 'Derriford Hospital, Plymouth, England.'}, {'ForeName': 'Rubin', 'Initials': 'R', 'LastName': 'Soomal', 'Affiliation': 'Jersey General Hospital, Jersey, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Borg', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry, Coventry, England.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Lerch', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2019.3337']
280,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
281,31135603,Deficient Emotional Self-Regulation in Children with Attention Deficit Hyperactivity Disorder: Mindfulness as a Useful Treatment Modality.,"OBJECTIVE


The aim of this study was to investigate the efficacy of a structured mindfulness group intervention program targeting deficient emotional self-regulation (DESR) in a sample of children with attention deficit hyperactivity disorder (ADHD).
METHOD


Seventy-two children aged 7 to 12 years with ADHD were randomized into 2 groups (mindfulness and control). The dysregulation profile was measured using the Child Behavior Checklist (CBCL) Attention/Anxiety-Depression/Aggression scales.
RESULTS


Children with ADHD who received mindfulness-based group therapy showed lower levels of DESR after treatment, with a reduction in CBCL dysregulation profile (F (1,63) = 4.81; p = 0.032). All ADHD symptoms showed a moderately significant positive correlation with DESR (p < 0.01). Children with combined-type showed higher levels of DESR than children with inattentive-type (p = 0.018); however, no statistically significant changes were observed in the combined-type after mindfulness treatment.
CONCLUSION


This study suggests that mindfulness in the form of structured group therapy might be clinically relevant in treating children with ADHD and thus make an impact on the overall clinical outcome, regardless of the ADHD subtype.",2019,"RESULTS


Children with ADHD who received mindfulness-based group therapy showed lower levels of DESR after treatment, with a reduction in CBCL dysregulation profile (F (1,63) = 4.81; p = 0.032).","['Seventy-two children aged 7 to 12 years with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', 'Children with Attention Deficit Hyperactivity Disorder']",['structured mindfulness group intervention program targeting deficient emotional self-regulation (DESR'],"['Child Behavior Checklist (CBCL', 'levels of DESR', 'CBCL dysregulation profile', 'Attention/Anxiety-Depression/Aggression scales']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0222045'}]",72.0,0.0486448,"RESULTS


Children with ADHD who received mindfulness-based group therapy showed lower levels of DESR after treatment, with a reduction in CBCL dysregulation profile (F (1,63) = 4.81; p = 0.032).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Huguet', 'Affiliation': 'Children and Adolescent Mental Health Research Group, Institut de Recerca Sant Joan de Déu, Barcelona, Spain.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Izaguirre Eguren', 'Affiliation': 'Child and Adolescent Psychiatry and Psychology Department of Hospital Sant Joan de Déu of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Miguel-Ruiz', 'Affiliation': 'Sant Joan de Déu-Fundació Privada, School of Nursing, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vall Vallés', 'Affiliation': 'Child and Adolescent Psychiatry and Psychology Department of Hospital Sant Joan de Déu of Barcelona, Barcelona, Spain.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Alda', 'Affiliation': 'Children and Adolescent Mental Health Research Group, Institut de Recerca Sant Joan de Déu, Barcelona, Spain.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000682']
282,32266764,The impact of five nights of sleep restriction on emotional reactivity.,"An inadequate amount of sleep can negatively affect emotional processing, causing behavioural and neurofunctional changes. However, unlike the condition of total sleep deprivation, which has been extensively studied, the effects of prolonged sleep restriction have received less attention. In this study, we evaluated, for the first time, the effects of five nights of sleep restriction (5 hr a night) on emotional reactivity in healthy subjects. Forty-two subjects were selected to participate, over two consecutive weeks, in two experimental conditions in counterbalanced order. The subjects were tested the morning after five nights of regular sleep and after five consecutive nights of sleep restriction. During the test, participants evaluated valence and arousal of 90 images selected from the International Affective Picture System. The subjects perceived pleasant and neutral pictures in a more negative way in the sleep-restriction condition compared to the sleep condition. This effect survived after removing the contribution of mood changes. In contrast, there was no significant difference between conditions for ratings of unpleasant pictures. These results provide the first evidence that an inadequate amount of sleep for five consecutive nights determines an alteration of the evaluation of pleasant and neutral stimuli, imposing a negative emotional bias. Considering the pervasiveness of insufficient sleep in modern society, our results have potential implications for daily life, as well as in clinical settings.",2020,The subjects perceived pleasant and neutral pictures in a more negative way in the sleep-restriction condition compared to the sleep condition.,['healthy subjects'],['sleep restriction (5\xa0hr a night'],"['ratings of unpleasant pictures', 'emotional reactivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",42.0,0.0143547,The subjects perceived pleasant and neutral pictures in a more negative way in the sleep-restriction condition compared to the sleep condition.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tempesta', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Salfi', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'De Gennaro', 'Affiliation': 'Department of Psychology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': ""Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.""}]",Journal of sleep research,['10.1111/jsr.13022']
283,32255549,"First-in-Human Studies of MW01-6-189WH, a Brain-Penetrant, Antineuroinflammatory Small-Molecule Drug Candidate: Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Studies in Healthy Adult Volunteers.","MW01-6-189WH (MW189) is a novel central nervous system-penetrant small-molecule drug candidate that selectively attenuates stressor-induced proinflammatory cytokine overproduction and is efficacious in intracerebral hemorrhage and traumatic brain injury animal models. We report first-in-human, randomized, double-blind, placebo-controlled phase 1 studies to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending intravenous doses of MW189 in healthy adult volunteers. MW189 was safe and well tolerated in single and multiple doses up to 0.25 mg/kg, with no clinically significant concerns. The most common drug-related treatment-emergent adverse event was infusion-site reactions, likely related to drug solution acidity. No clinically concerning changes were seen in vital signs, electrocardiograms, physical or neurological examinations, or safety laboratory results. PK analysis showed dose-proportional increases in plasma concentrations of MW189 after single or multiple doses, with approximately linear kinetics and no significant drug accumulation. Steady state was achieved by dose 3 for all dosing cohorts. A pilot pharmacodynamic study administering low-dose endotoxin to induce a systemic inflammatory response was done to evaluate the effects of a single intravenous dose of MW189 on plasma cytokine levels. MW189 treatment resulted in lower levels of the proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10 compared with placebo treatment. The outcomes are consistent with the pharmacological mechanism of MW189. Overall, the safety profile, PK properties, and pharmacodynamic effect support further development of MW189 for patients with acute brain injury.",2020,MW189 treatment resulted in lower levels of the proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10 compared with placebo treatment.,"['healthy adult volunteers', 'Healthy Adult Volunteers', 'patients with acute brain injury']","['MW189', 'endotoxin', 'placebo', 'MW01-6-189WH (MW189']","['plasma concentrations of MW189', 'vital signs, electrocardiograms, physical or neurological examinations, or safety laboratory results', 'safety, tolerability, and pharmacokinetics (PK', 'safety profile, PK properties, and pharmacodynamic effect', 'safe and well tolerated', 'plasma cytokine levels', 'proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085742', 'cui_str': 'Acute Brain Injuries'}]","[{'cui': 'C0014264', 'cui_str': 'Bacterial endotoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.286496,MW189 treatment resulted in lower levels of the proinflammatory cytokine TNF-α and higher levels of the anti-inflammatory cytokine IL-10 compared with placebo treatment.,"[{'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Van Eldik', 'Affiliation': 'Sanders-Brown Center on Aging, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Lumy', 'Initials': 'L', 'LastName': 'Sawaki', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bowen', 'Affiliation': 'Bluegrass Research Consultants, Inc., Versailles, Kentucky, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Neurology, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Noveck', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, North Carolina, USA.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Hauser', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, North Carolina, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Jordan', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Durham, North Carolina, USA.'}, {'ForeName': 'Tracy G', 'Initials': 'TG', 'LastName': 'Spears', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Huali', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Watt', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina, USA.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Raja', 'Affiliation': 'Department of Neurology, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Saktimayee M', 'Initials': 'SM', 'LastName': 'Roy', 'Affiliation': 'Department of Pharmacology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'D Martin', 'Initials': 'DM', 'LastName': 'Watterson', 'Affiliation': 'Department of Pharmacology, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Guptill', 'Affiliation': 'Department of Neurology, Duke University, Durham, North Carolina, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.795']
284,32101426,Lowering Urinary Phthalate Metabolite Concentrations among Children by Reducing Contaminated Dust in Housing Units: A Randomized Controlled Trial and Observational Study.,"Dust in homes can contain phthalates that may adversely affect child development, but whether residential interventions and dust removal can prevent children's exposure to phthalates is unknown. We quantified the influence of a residential lead hazard intervention and dust control on children's urinary phthalate metabolite concentrations. Between 2003 and 2006, The Health Outcomes and Measures of the Environment (HOME) Study randomized 355 pregnant women to receive an intervention to reduce either residential lead or injury hazards before delivery. We quantified eight urinary phthalate metabolites from 288 children at ages 1, 2, or 3 years (680 observations). During yearly home visits, we assessed dust accumulation in housing units. Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group. Monoethyl phthalate concentrations did not differ by group. In observational analyses, children living in housing units that appeared clean had 12-17% lower concentrations of these phthalate metabolites and monobenzyl phthalate, compared to children living in housing units with more dust accumulation. Features of this lead hazard intervention and measures to control dust may reduce children's exposure to phthalates found in building materials and household furnishings.",2020,"Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group.","['355 pregnant women to receive an', ""children's urinary phthalate metabolite concentrations"", '288 children at ages 1, 2, or 3 years (680 observations', 'children by reducing contaminated dust in housing units']","['residential lead hazard intervention and dust control', 'intervention to reduce either residential lead or injury hazards before delivery']","['Health Outcomes and Measures of the Environment', 'concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate', 'Monoethyl phthalate concentrations']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0220894', 'cui_str': 'phthalate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205279', 'cui_str': 'Contaminated (qualifier value)'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220894', 'cui_str': 'phthalate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3659034', 'cui_str': 'monoethyl phthalate'}]",355.0,0.0726831,"Children in the lead intervention group had 11-12% lower concentrations of the sum of di(2-ethylhexyl) phthalate metabolites, monocarboxyoctyl phthalate, and monocarboxynonyl phthalate compared to the injury intervention group.","[{'ForeName': 'Clara G', 'Initials': 'CG', 'LastName': 'Sears', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Lanphear', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia 30329, United States.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Department of Environmental Health, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States.'}, {'ForeName': 'Julianne', 'Initials': 'J', 'LastName': 'Skarha', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Yolton', 'Affiliation': ""Department of Pediatrics, Division of General and Community Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Braun', 'Affiliation': 'Department of Epidemiology, Brown University, Providence, Rhode Island 02912, United States.'}]",Environmental science & technology,['10.1021/acs.est.9b04898']
285,32176574,Self-Regulation Failure Reduces the Effect Alcohol Portrayals in Movies on Indirect Attitudes toward Alcohol.,"We investigated the cognitive mechanisms underlying change in implicit cognitions following exposure to alcohol portrayals. More precisely, we tested in an experimental study whether this change depends on controlled or automatic processes by putting participants in a state of self-regulatory fatigue prior to being exposed to alcohol portrayals. Ninety participants were randomly assigned to a 2 (attitude measure: before vs after) × 2 (alcohol portrayal: yes vs no) × 2 (ego depletion: yes vs no) mixed design to assess whether the effects of alcohol portrayals affected cognitive resources. It was hypothesized that alcohol portrayals would have more of an impact on participants submitted to an ego-depletion task. We found a change in attitudes toward alcohol only for participants that had been exposed to alcohol portrayals, and who had not been cognitively depleted. These results suggest that these changes rely on controlled, resource-dependent processes rather than on purely associative and automatic processes. Implications regarding alcohol advertising effects on public health are discussed.",2020,"We found a change in attitudes toward alcohol only for participants that had been exposed to alcohol portrayals, and who had not been cognitively depleted.","['Ninety participants', 'putting participants in a state of self-regulatory fatigue prior to being exposed to alcohol portrayals', 'participants that had been exposed to alcohol portrayals, and who had not been cognitively depleted']",[],[],"[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",[],[],90.0,0.0179897,"We found a change in attitudes toward alcohol only for participants that had been exposed to alcohol portrayals, and who had not been cognitively depleted.","[{'ForeName': 'Oulmann', 'Initials': 'O', 'LastName': 'Zerhouni', 'Affiliation': 'University Paris Nanterre.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bègue', 'Affiliation': 'University Grenoble Alpes.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sarda', 'Affiliation': 'University Grenoble Alpes.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Gentile', 'Affiliation': 'Iowa State University.'}]",The Journal of psychology,['10.1080/00223980.2020.1732853']
286,32265500,Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study.,"Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.",2020,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","['patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy', 'patients with CML-CP', 'Adult patients with CML-CP', 'patients with suboptimal response to first-line imatinib']","['Dasatinib vs. imatinib', '100\u2009mg dasatinib (n\u2009=\u2009174) or continue imatinib']","['probability of deep molecular response and superior survival', '2-year cumulative MMR rate', 'Adverse events', 'rate of major molecular response (MMR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0336482,"Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat).","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta University, Augusta, GA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Jianyu', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': ""Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China.""}, {'ForeName': 'Huanling', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hochhaus', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Dong-Wook', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Jerald', 'Initials': 'J', 'LastName': 'Radich', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martin-Regueira', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Oumar', 'Initials': 'O', 'LastName': 'Sy', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Gurnani', 'Affiliation': 'Bristol Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Saglio', 'Affiliation': 'University of Turin, Turin, Italy.'}]",Leukemia,['10.1038/s41375-020-0805-1']
287,32251641,"Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial.","BACKGROUND


A monovalent, parenteral, subunit rotavirus vaccine was well tolerated and immunogenic in adults in the USA and in toddlers and infants in South Africa, but elicited poor responses against heterotypic rotavirus strains. We aimed to evaluate safety and immunogenicity of a trivalent vaccine formulation (P2-VP8-P[4],[6],[8]).
METHODS


A double-blind, randomised, placebo-controlled, dose-escalation, phase 1/2 study was done at three South African research sites. Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment. In the dose-escalation phase, adults and toddlers were randomly assigned in blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo. In the expanded phase, infants were randomly assigned in a 1:1:1:1 ratio to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo, in block sizes of four. Participants, parents of participants, and clinical, data, and laboratory staff were masked to treatment assignment. Adults received an intramuscular injection of vaccine or placebo in the deltoid muscle on the day of randomisation (day 0), day 28, and day 56; toddlers received a single injection of vaccine or placebo in the anterolateral thigh on day 0. Infants in both phases received an injection of vaccine or placebo in the anterolateral thigh on days 0, 28, and 56, at approximately 6, 10, and 14 weeks of age. Primary safety endpoints were local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events within 28 days after each injection in all participants who received at least one injection. Primary immunogenicity endpoints were analysed in infants in either phase who received all planned injections, had blood samples analysed at the relevant timepoints, and presented no major protocol violations considered to have an effect on the immunogenicity results of the study, and included serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses measured 4 weeks after the final injection in vaccine compared with placebo groups. This trial is registered with ClinicalTrials.gov, NCT02646891.
FINDINGS


Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group, 140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group) were randomly assigned, received at least one dose, and were assessed for safety. There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups. There were no serious adverse events within 28 days of injection in adults, whereas one serious adverse event occurred in a toddler (febrile convulsion in the 30 μg group) and 23 serious adverse events (four in placebo, ten in 15 μg, four in 30 μg, and five in 90 μg groups) occurred among 20 infants, most commonly respiratory tract infections. One death occurred in an infant within 28 days of injection due to pneumococcal meningitis. In 528 infants (130 in placebo, 132 in 15 μg, 132 in 30 μg, and 134 in 90 μg groups), adjusted anti-P2-VP8 IgG seroresponses (≥4-fold increase from baseline) to P[4], P[6], and P[8] antigens were significantly higher in the 15 μg, 30 μg, and 90 μg groups (99-100%) than in the placebo group (10-29%; p<0·0001). Although significantly higher than in placebo recipients (9-10%), anti-P2-VP8 IgA seroresponses (≥4-fold increase from baseline) to each individual antigen were modest (20-34%) across the 15 μg, 30 μg, and 90 μg groups. Adjusted neutralising antibody seroresponses in infants (≥2·7-fold increase from baseline) to DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]) were higher in vaccine recipients than in placebo recipients: p<0·0001 for all comparisons.
INTERPRETATION


The trivalent P2-VP8 vaccine was well tolerated, with promising anti-P2-VP8 IgG and neutralising antibody responses across the three vaccine P types. Our findings support advancing the vaccine to efficacy testing.
FUNDING


Bill & Melinda Gates Foundation.",2020,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","['528 infants (130 in', '140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group', ""Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment"", 'adults in the USA and in toddlers and infants in South Africa', 'Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group', 'three South African research sites', 'adults and toddlers']","['vaccine or placebo', 'parenteral trivalent P2-VP8 subunit rotavirus vaccine', 'placebo', 'intramuscular injection of vaccine or placebo', 'vaccine, or placebo', 'blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo', 'trivalent vaccine formulation (P2-VP8-P[4],[6],[8']","['serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses', 'serious adverse events', 'One death', 'local or systemic adverse events, or unsolicited adverse events', 'safety and immunogenicity', 'Safety and immunogenicity', '23 serious adverse events', 'Adjusted neutralising antibody seroresponses', 'local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events', 'adjusted anti-P2-VP8 IgG seroresponses', 'anti-P2-VP8 IgA seroresponses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4.0,0.743237,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Groome', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: groomem@rmpru.co.za.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Family Clinical Research Unit, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Maysseb', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'PATH, Washington, DC, USA; Novavax, Gaithersburg, MD, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Power', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cryz', 'Affiliation': 'PATH, Washington, DC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30001-3']
288,32035412,Physical Activity Intervention Effects on Sedentary Time in Spanish-Speaking Latinas.,"BACKGROUND


Latinas have high rates of sedentary behavior and related health disparities, but it is unknown if interventions to increase physical activity will also reduce sedentary time. The current study examined changes in objectively measured sedentary time among Latinas in a randomized controlled trial of a physical activity intervention.
METHODS


Spanish-speaking Latinas (N = 202) were randomized to an exercise or wellness group and wore an accelerometer at baseline, 6 months, and 12 months.
RESULTS


Participants were sedentary on an average of 8.86 hours per day (SD = 2.60) at baseline. The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02). The intervention effect on sedentary behavior remained after controlling for moderate to vigorous physical activity. Additionally, time spent in moderate to vigorous physical activity was positively associated with more sedentary time (P = .04).
CONCLUSION


An intervention to increase moderate to vigorous physical activity resulted in greater sedentary time, raising concerns regarding compensation and highlighting the need for interventions to address both physical activity and sedentary behavior to improve public health.",2020,"The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02).","['Sedentary Time in Spanish-Speaking Latinas', 'Spanish-speaking Latinas (N = 202']","['Physical Activity Intervention', 'physical activity intervention', 'exercise or wellness group and wore an accelerometer at baseline, 6 months, and 12 months']","['sedentary time', 'sedentary behavior', 'time spent in moderate to vigorous physical activity']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",202.0,0.0457501,"The intervention group had significantly greater increases in sedentary time compared with the control group, with the intervention group engaging in 146 more minutes per week of sedentary time at 6 months and 254 minutes per week of sedentary time at 12 months than the control group (P = .02).","[{'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': ''}, {'ForeName': 'Dori', 'Initials': 'D', 'LastName': 'Pekmezi', 'Affiliation': ''}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': ''}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0112']
289,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
290,31178434,Lack of Durable Improvements in β-Cell Function Following Withdrawal of Pharmacological Interventions in Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes.,"OBJECTIVE


The Restoring Insulin Secretion (RISE) Adult Medication Study compared pharmacological approaches targeted to improve β-cell function in individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration.
RESEARCH DESIGN AND METHODS


A total of 267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied. Participants were randomized to receive 12 months of metformin alone, 3 months of insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin, 12 months of liraglutide combined with metformin, or 12 months of placebo. β-Cell function was assessed using hyperglycemic clamps at baseline, 12 months (on treatment), and 15 months (3 months off treatment). The primary outcome was β-cell function at 15 months compared with baseline.
RESULTS


All three active treatments produced on-treatment reductions in weight and improvements in HbA 1c  compared with placebo; the greatest reductions were seen in the liraglutide plus metformin group. At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group. Despite on-treatment benefits, 3 months after treatment withdrawal there were no sustained improvements in β-cell function in any treatment group.
CONCLUSIONS


In adults with IGT or recently diagnosed type 2 diabetes, interventions that improved β-cell function during active treatment failed to produce persistent benefits after treatment withdrawal. These observations suggest that continued intervention may be required to alter the progressive β-cell dysfunction in IGT or early type 2 diabetes.",2019,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","['Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes', 'individuals with impaired glucose tolerance (IGT) or treatment-naive type 2 diabetes of <12 months duration', '267 adults with IGT ( n  = 197, 74%) or recently diagnosed type 2 diabetes ( n  = 70, 26%) were studied']","['liraglutide combined with metformin', 'placebo', 'insulin glargine with a target fasting glucose <5 mmol/L followed by 9 months of metformin', 'metformin', 'liraglutide plus metformin']","['Restoring Insulin Secretion (RISE', 'β-cell function', 'weight and improvements in HbA 1c', 'arginine-stimulated incremental C-peptide response', 'glucose-stimulated C-peptide responses', 'β-Cell function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]",267.0,0.0446286,"At 12 months, glucose-stimulated C-peptide responses improved in the three active treatment groups and were greatest in the liraglutide plus metformin group, but the arginine-stimulated incremental C-peptide response was reduced in the liraglutide plus metformin group.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0556']
291,32248227,Electrical Stimulation Therapies for Active Duty Military with Patellofemoral Pain Syndrome: A Randomized Trial.,"INTRODUCTION


Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disorder among military service members that causes knee pain, quadriceps strength loss, and impaired motor performance in otherwise healthy individuals. PFPS poses a threat to the health, fitness, and subsequent readiness of the total force. The goal of rehabilitation for military service members with PFPS is to regain physical capacity of strength and function and to reduce pain, in order to restore readiness in this population. The randomized controlled trial reported here compared an active home exercise program (HEP) alone with three different electrical stimulation treatment regimens implemented concurrently with HEP postulated improvements in lower extremity strength and physical functional performance while also reducing pain in active duty military diagnosed with PFPS.
MATERIALS AND METHODS


After baseline testing, 130 active duty military members with PFPS were randomized to 1 of 4 treatment groups: (1) neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only. The primary outcome measure was degree of change in knee flexion and extension strength over 9 weeks. Secondary outcomes were physical functional performance and knee pain. The primary analyses used repeated measures, linear mixed-effects models with a random effect for subject, time as a continuous variable, group as a categorical variable, and a group and time interaction to test for differences in change over time among the groups.
RESULTS


All three electrical stimulation treatment groups improved in knee extension strength in the PFPS limb to a greater extent than the HEP alone group over the 9-week treatment period. The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb. The reported pain improved over time for all treatment groups with no significant group differences. All three stimulation groups performed better on the 6-min walk test than the HEP alone group.
CONCLUSION


The findings from this study showed that all three electrical stimulation with HEP treatment groups showed greater improvement in strength compared to the HEP alone group. These findings could offer alternative forms of rehabilitation for AD military with PFPS as these treatment regimens can be easily implemented at home station or during deployment.",2020,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"['otherwise healthy individuals', 'Active Duty Military with Patellofemoral Pain Syndrome', 'military service members with', 'active duty military diagnosed with PFPS', '130 active duty military members with PFPS']","['active home exercise program (HEP', 'Electrical Stimulation Therapies', 'neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only', 'HEP', 'PFPS']","['physical functional performance and knee pain', 'knee flexion strength', 'pain', 'knee extension strength', 'lower extremity strength and physical functional performance', 'strength', 'degree of change in knee flexion and extension strength']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}]","[{'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",130.0,0.0562604,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Talbot', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}, {'ForeName': 'Zack', 'Initials': 'Z', 'LastName': 'Solomon', 'Affiliation': 'Physical Therapy Services, Dunham U.S. Army Health Clinic, Carlisle Barracks, PA 17013.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'Byrd Clinic Physical Therapy, Fort Campbell, KY 42240.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Morrell', 'Affiliation': 'Department of Mathematics and Statistics, Loyola University Maryland, Baltimore, MD 21210-2699.'}, {'ForeName': 'E Jeffrey', 'Initials': 'EJ', 'LastName': 'Metter', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}]",Military medicine,['10.1093/milmed/usaa037']
292,30875348,A randomized phase II study to determine the efficacy and tolerability of two doses of eribulin plus lapatinib in trastuzumab-pretreated patients with HER-2-positive metastatic breast cancer (E-VITA).,"The E-VITA study evaluated the efficacy and tolerability of two schedules of eribulin and lapatinib in patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer. This multicenter, open-label phase II trial, randomly assigned patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer to lapatinib 1000 mg daily with eribulin 1.23 mg/m (equivalent to 1.4 mg/m eribulin mesylate) days 1+8 every 21 days (split-dose arm) or eribulin 1.76 mg/m (equivalent to 2.0 mg/m eribulin mesylate) day 1 every 21 days (3-weekly arm). Time to progression and tolerability were defined as primary end points; no sample size calculation for formal comparison of efficacy data has been performed. Secondary end points included objective response rate, clinical benefit rate, and overall survival. Overall, 43 patients of a planned number of 80 patients were recruited. At a median follow-up of 28.7 months, the median time to progression was 8.1 months [95% confidence interval (CI): 4.8-9.4] in the split-dose arm and 6.5 months (95% CI: 4.6-13.4) in the 3-weekly arm. Objective response rate was 52.4% (95% CI: 31.0-73.7) in the split-dose arm and 45.0% (95% CI: 23.2-66.8) in the 3-weekly arm, and clinical benefit rate was 71.4% (95% CI: 52.1-90.8) and 75.0% (95% CI: 56.0-94.0), respectively. Overall survival was also similar in both arms. The most frequent grade 3-4 adverse events were neutropenia (58.5%) and leukopenia (39.0%). The combination of eribulin and lapatinib showed an acceptable safety profile with less toxicity observed in the eribulin 1.23 mg/m day 1+8 group. This might be an alternative regimen when other treatment options are exhausted. Therefore, further clinical studies are warranted.",2019,"Objective response rate was 52.4% (95% CI: 31.0-73.7) in the split-dose arm and 45.0% (95% CI: 23.2-66.8) in the 3-weekly arm, and clinical benefit rate was 71.4% (95% CI: 52.1-90.8) and 75.0% (95% CI: 56.0-94.0), respectively.","['43 patients of a planned number of 80 patients were recruited', 'pretreated patients with HER-2-positive metastatic breast cancer (E-VITA', 'patients with trastuzumab-pretreated HER-2-positive metastatic breast cancer']","['eribulin and lapatinib', 'trastuzumab-pretreated HER-2-positive metastatic breast cancer to lapatinib 1000\u2009mg daily with eribulin 1.23\u2009mg/m (equivalent to 1.4\u2009mg/m eribulin mesylate', 'trastuzumab', 'eribulin plus lapatinib']","['leukopenia', 'median time to progression', 'Objective response rate', 'objective response rate, clinical benefit rate, and overall survival', 'clinical benefit rate', 'efficacy and tolerability', 'Overall survival', 'toxicity', 'neutropenia', 'Time to progression and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C2350866', 'cui_str': 'eribulin'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517495', 'cui_str': '1.23'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C2608038', 'cui_str': 'eribulin mesylate'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",,0.100181,"Objective response rate was 52.4% (95% CI: 31.0-73.7) in the split-dose arm and 45.0% (95% CI: 23.2-66.8) in the 3-weekly arm, and clinical benefit rate was 71.4% (95% CI: 52.1-90.8) and 75.0% (95% CI: 56.0-94.0), respectively.","[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Bischoff', 'Affiliation': ""Women's Hospital, Städtisches Klinikum Dessau.""}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Barinoff', 'Affiliation': ""Women's Hospital, Agaplesion Markus-Krankenhaus, Frankfurt am Main.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mundhenke', 'Affiliation': ""University Women's Hospital Kiel, UK-SH, Kiel.""}, {'ForeName': 'Dirk O', 'Initials': 'DO', 'LastName': 'Bauerschlag', 'Affiliation': ""University Women's Hospital Kiel, UK-SH, Kiel.""}, {'ForeName': 'Serban-Dan', 'Initials': 'SD', 'LastName': 'Costa', 'Affiliation': ""University Women's Hospital Magdeburg, Otto-von Guericke-Universität, Magdeburg.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Herr', 'Affiliation': ""University Women's Hospital Würzburg.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lübbe', 'Affiliation': 'Breast Center, Diakovere Henriettenstiftung, Hannover.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'National Center for Tumor Diseases, University Hospital Heidelberg.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Maass', 'Affiliation': ""University Women's Hospital Kiel, UK-SH, Kiel.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': ""Women's Hospital, University Hospital Tübingen.""}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': ""Women's Hospital, UKE University Hospital Hamburg-Eppendorf KMTZ, Hamburg.""}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ""Women's Hospital, University Medical Center Mainz.""}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': ""Women's Hospital, University Hospital Rostock.""}, {'ForeName': 'Sherko', 'Initials': 'S', 'LastName': 'Kümmel', 'Affiliation': ""Women's Hospital, Kliniken Essen Mitte Evang. Huyssens-Stiftung, Essen.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schumacher', 'Affiliation': 'Breast Center, St. Elisabeth Krankenhaus Hohenlind, Cologne.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Krabisch', 'Affiliation': ""Women's Hospital, Klinikum Chemnitz, Germany.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Thill', 'Affiliation': ""Women's Hospital, Agaplesion Markus-Krankenhaus, Frankfurt am Main.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000722']
293,32187119,Enhanced mindfulness-based stress reduction in episodic migraine: a randomized clinical trial with magnetic resonance imaging outcomes.,"We aimed to evaluate the efficacy of an enhanced mindfulness-based stress reduction (MBSR+) vs stress management for headache (SMH). We performed a randomized, assessor-blind, clinical trial of 98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n = 50) with SMH (n = 48). MBSR+ and SMH were delivered weekly by group for 8 weeks, then biweekly for another 8 weeks. The primary clinical outcome was reduction in headache days from baseline to 20 weeks. Magnetic resonance imaging (MRI) outcomes included activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula to DLPFC and cognitive task network, and gray matter volume of DLPFC, dorsal anterior insula, and anterior midcingulate. Secondary outcomes were headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses. Reduction in headache days from baseline to 20 weeks was greater for MBSR+ (7.8 [95% CI, 6.9-8.8] to 4.6 [95% CI, 3.7-5.6]) than for SMH (7.7 [95% CI 6.7-8.7] to 6.0 [95% CI, 4.9-7.0]) (P = 0.04). Fifty-two percent of the MBSR+ group showed a response to treatment (50% reduction in headache days) compared with 23% in the SMH group (P = 0.004). Reduction in headache-related disability was greater for MBSR+ (59.6 [95% CI, 57.9-61.3] to 54.6 [95% CI, 52.9-56.4]) than SMH (59.6 [95% CI, 57.7-61.5] to 57.5 [95% CI, 55.5-59.4]) (P = 0.02). There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed. Enhanced mindfulness-based stress reduction is an effective treatment option for episodic migraine.",2020,"There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed.","['episodic migraine', '98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n=50) to SMH (n=48', 'headache (SMH']","['Enhanced mindfulness based stress reduction (MBSR', 'SMH', 'enhanced mindfulness based stress reduction (MBSR', 'MBSR+ and SMH', 'MBSR']","['headache days', 'headache-related disability', 'activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula (daINS) to DLPFC and cognitive task network, and gray matter volume of DLPFC, daINS, and anterior midcingulate', 'reduction in headache days', 'headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses']","[{'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula (body structure)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",98.0,0.12879,"There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Shana A B', 'Initials': 'SAB', 'LastName': 'Burrowes', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kearson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Luma', 'Initials': 'L', 'LastName': 'Samawi', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Furman', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Keaser', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Neda F', 'Initials': 'NF', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Magyari', 'Affiliation': 'Private Mindfulness-based Psychotherapy Practice, Baltimore, MD, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Goloubeva', 'Affiliation': 'University of Maryland Greenebaum Comprehensive Cancer Center, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Madhav', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'B Lee', 'Initials': 'BL', 'LastName': 'Peterlin', 'Affiliation': 'Neuroscience Institute, Penn Medicine Lancaster General Health, Lancaster, PA, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Haythornthwaite', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000001860']
294,31498375,Effectiveness of Behaviorally Designed Gamification Interventions With Social Incentives for Increasing Physical Activity Among Overweight and Obese Adults Across the United States: The STEP UP Randomized Clinical Trial.,"Importance


Gamification, the use of game design elements in nongame contexts, is increasingly being used in workplace wellness programs and digital health applications. However, the best way to design social incentives in gamification interventions has not been well examined.
Objective


To assess the effectiveness of support, collaboration, and competition within a behaviorally designed gamification intervention to increase physical activity among overweight and obese adults.
Design, Setting, and Participants


This 36-week randomized clinical trial with a 24-week intervention and 12-week follow-up assessed 602 adults from 40 states with body mass indexes (calculated as weight in kilograms divided by height in meters squared) of 25 or higher from February 12, 2018, to March 17, 2019.
Interventions


Participants used a wearable device to track daily steps, established a baseline, selected a step goal increase, were randomly assigned to a control (n = 151) or to 1 of 3 gamification interventions (support [n = 151], collaboration [n = 150], and competition [n = 150]), and were remotely monitored. The control group received feedback from the wearable device but no other interventions for 36 weeks. The gamification arms were entered into a 24-week game designed using insights from behavioral economics with points and levels for achieving step goals. No gamification interventions occurred during follow-up.
Main Outcomes and Measures


The primary outcome was change in mean daily steps from baseline through the 24-week intervention period.
Results


A total of 602 participants (mean [SD] age, 39 [10] years; mean [SD] body mass index, 30 [5]; 427 [70.9%] male) were included in the study. Compared with controls, participants had a significantly greater increase in mean daily steps from baseline during the intervention in the competition arm (adjusted difference, 920; 95% CI, 513-1328; P < .001), support arm (adjusted difference, 689; 95% CI, 267-977; P < .001), and collaboration arm (adjusted difference, 637; 95% CI, 258-1017; P = .001). During follow-up, physical activity remained significantly greater in the competition arm than in the control arm (adjusted difference, 569; 95% CI, 142-996; P = .009) but was not significantly greater in the support (adjusted difference, 428; 95% CI, 19-837; P = .04) and collaboration (adjusted difference, 126; 95% CI, -248 to 468; P = .49) arms than in the control arm.
Conclusions and Relevance


All 3 gamification interventions significantly increased physical activity during the 24-week intervention, and competition was the most effective. Physical activity was lower in all arms during follow-up and only remained significantly greater in the competition arm than in the control arm.
Trial Registration


ClinicalTrials.gov identifier: NCT03311230.",2019,"Physical activity was lower in all arms during follow-up and only remained significantly greater in the competition arm than in the control arm.
","['602 adults from 40 states with body mass indexes (calculated as weight in kilograms divided by height in meters squared) of 25 or higher from February 12, 2018, to March 17, 2019', 'Overweight and Obese Adults Across the United States', 'overweight and obese adults', '602 participants (mean [SD] age', '39 [10] years; mean [SD] body mass index, 30 [5]; 427 [70.9%] male) were included in the study']","['control (n\u2009=\u2009151) or to 1 of 3 gamification interventions (support [n\u2009=\u2009151], collaboration [n\u2009=\u2009150], and competition [n\u2009=\u2009150]), and were remotely monitored', 'support, collaboration, and competition within a behaviorally designed gamification intervention', 'Behaviorally Designed Gamification Interventions With Social Incentives']","['mean daily steps', 'physical activity', 'change in mean daily steps', 'gamification interventions', 'Physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",602.0,0.13168,"Physical activity was lower in all arms during follow-up and only remained significantly greater in the competition arm than in the control arm.
","[{'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Harrison', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Fortunato', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ai Leen', 'Initials': 'AL', 'LastName': 'Oon', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reh', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Szwartz', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Guszcza', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steier', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania.'}, {'ForeName': 'Pameljit', 'Initials': 'P', 'LastName': 'Kalra', 'Affiliation': 'Deloitte Consulting, Philadelphia, Pennsylvania.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hilbert', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.3505']
295,31206808,"A randomized, open-label pharmacokinetic trial of tacrolimus extended-release dosing in obese de novo kidney transplant recipients.","PURPOSE


Tacrolimus extended-release (TAC-ER; Astagraf XL ®  ) is utilized in many immunosuppressive regimens post-renal transplantation. Current dosing recommendation for the TAC-ER in renal transplant is 0.15-0.2 mg/kg/day administered once daily. The purpose of this study was to determine the best method of dosing TAC-ER in obese renal transplant recipients.
METHODS


De novo obese kidney transplant recipients were randomized to receive TAC-ER 0.15 mg/kg/day based on either adjusted body weight (aBW) or ideal body weight (IBW). Post-transplant patients underwent three pharmacokinetic assessments over 14 days. The primary endpoint was the difference in TAC-ER exposure (AUC0-24) in obese patients dosed using aBW compared with IBW.
RESULTS


A total of 20 obese renal transplant recipients were randomized to participate in the study (10 aBW and 10 IBW). Results of the primary outcome (AUC0-24) on Study Day 1, 7, and 14 were not statistically different between the two groups. There was no difference in the number of days to therapeutic trough concentration between the two dosing weights (aBW = 5.1, IBW = 4.9, days; P = 0.90).
CONCLUSION


In a population of obese renal transplant recipients, comparable trough concentrations and overall exposure in both groups indicate that IBW may be preferred, as less initial drug was needed to attain adequate exposure.",2019,"There was no difference in the number of days to therapeutic trough concentration between the two dosing weights (aBW = 5.1, IBW = 4.9, days; P = 0.90).
","['De novo obese kidney transplant recipients', 'obese de novo kidney transplant recipients', 'obese renal transplant recipients', '20 obese renal transplant recipients']","['TAC-ER 0.15\xa0mg/kg/day based on either adjusted body weight (aBW) or ideal body weight (IBW', 'tacrolimus', 'TAC-ER']","['TAC-ER exposure (AUC0-24', 'number of days to therapeutic trough concentration']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0421272', 'cui_str': 'Normal Body Weight'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",20.0,0.0431282,"There was no difference in the number of days to therapeutic trough concentration between the two dosing weights (aBW = 5.1, IBW = 4.9, days; P = 0.90).
","[{'ForeName': 'Natalia M', 'Initials': 'NM', 'LastName': 'Jasiak-Panek', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wenzler', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Shree', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Thielke', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Progar', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Shitalben', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Brandt', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Yi-Jen', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Benedetti', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'West-Thielke', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of Illinois at Chicago, Chicago, Illinois.'}]",Clinical transplantation,['10.1111/ctr.13640']
296,32248355,Circumferential Heller myotomy can relieve chest pain in patients with achalasia: a prospective clinical trial.,"BACKGROUND


Noncardiac chest pain often coexists with dysphagia in patients diagnosed with achalasia. The current standard treatment for achalasia, laparoscopic Heller myotomy with Dor fundoplication, has an insufficient effect on noncardiac chest pain. The aim of this study is to investigate the efficacy of circumferential Heller myotomy on esophageal chest pain in patients with achalasia.
METHODS


Twenty patients diagnosed with achalasia who complained of noncardiac chest pain were recruited and underwent circumferential Heller myotomy. Using an institutional achalasia database, we randomly selected 60 patients who underwent standard laparoscopic Heller myotomy with Dor fundoplication, based on a 3-to-1 propensity score-matching analysis. We compared surgical outcomes between the circumferential Heller myotomy and the laparoscopic Heller myotomy with Dor fundoplication groups.
RESULTS


Patients undergoing circumferential Heller myotomy had a higher rate of postoperative noncardiac chest pain relief than the laparoscopic Heller myotomy with Dor fundoplication group [95% (19/20) vs. 75% (45/60), p = 0.045]. No differences in dysphagia and vomiting were found between groups (p = 0.783 and p = 0.645, respectively). Patients in the circumferential Heller myotomy group had significantly better esophageal clearance. The prevalence of reflux endoscopic esophagitis was higher in the circumferential Heller myotomy group than in the control group [35.0% (7/20) vs. 10.0% (6/60), p = 0.015].
CONCLUSIONS


There is promising early evidence that circumferential Heller myotomy may be effective in the treatment of achalasia-related chest pain. Further research, including larger randomized studies with long-term follow-up, is warranted.",2020,"The prevalence of reflux endoscopic esophagitis was higher in the circumferential Heller myotomy group than in the control group [35.0% (7/20) vs. 10.0% (6/60), p = 0.015].
","['patients diagnosed with achalasia', 'Twenty patients diagnosed with achalasia who complained of noncardiac chest pain were recruited and underwent circumferential Heller myotomy', '60 patients who underwent', 'patients with achalasia']","['Circumferential Heller myotomy', 'circumferential Heller myotomy', 'standard laparoscopic Heller myotomy with Dor fundoplication']","['rate of postoperative noncardiac chest pain relief', 'esophageal chest pain', 'prevalence of reflux endoscopic esophagitis', 'esophageal clearance', 'dysphagia and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014848', 'cui_str': 'Achalasia of esophagus'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C4505237', 'cui_str': ""Heller's Myotomy""}]","[{'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C4505237', 'cui_str': ""Heller's Myotomy""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4505238', 'cui_str': 'Laparoscopic Heller Cardiomyotomy'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0476281', 'cui_str': 'Non-cardiac chest pain'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0232533', 'cui_str': 'Esophageal chest pain'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",60.0,0.0654229,"The prevalence of reflux endoscopic esophagitis was higher in the circumferential Heller myotomy group than in the control group [35.0% (7/20) vs. 10.0% (6/60), p = 0.015].
","[{'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Yano', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan. f-yano@jikei.ac.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Omura', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Se Ryung', 'Initials': 'SR', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Akimoto', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Yanaga', 'Affiliation': 'Department of Surgery, The Jikei University School of Medicine, 3-25-8, Nishishimbashi, Minato-ku, Tokyo, 105-8461, Japan.'}]",Esophagus : official journal of the Japan Esophageal Society,['10.1007/s10388-020-00738-5']
297,32231293,Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study.,"BACKGROUND


Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown.
METHODS


In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS).
RESULTS


From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51-1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51-0.96).
CONCLUSIONS


Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.",2020,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","['From 1992 to 1997, 1214 patients were included', 'node-positive and high-risk node- negative breast cancer patients', 'high-risk early breast cancer patients', 'early breast cancer patients']","['adjuvant fluorouracil, epirubicin and cyclophosphamide', 'Dose-dense adjuvant chemotherapy']","['15-year OS', 'overall survival (OS), and the secondary endpoint was event-free survival (EFS', '15-year EFS']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1214.0,0.167571,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': 'Department of Oncology, Transplants and new Technologies U.O. Oncologia Medica I, Ospedale S. Chiara, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56100, Pisa, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Via Genova 30, 17100, Savona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pastorino', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Levaggi', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': ""Alessia D'"", 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Buzzatti', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinelli', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Integrated Diagnostic Surgical Sciences, U.O. Clinica di chirurgia senologica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Department of Surgical Sciences (DISC), University of Genova, Largo Rosanna Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy. lucia.delmastro@hsanmartino.it.'}]",British journal of cancer,['10.1038/s41416-020-0816-8']
298,32118347,Comparable efficacy with similarly low risk of hypoglycaemia in patient- vs physician-managed basal insulin initiation and titration in insulin-naïve type 2 diabetic subjects: The Italian Titration Approach Study.,"AIMS


People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM.
MATERIALS AND METHODS


ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA 1c  . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs), and adverse events.
RESULTS


Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA 1c  reduction from baseline was non-inferior in patient- vs physician-managed arms [least squares mean (LSM) change (SE): -1.60% (0.06) vs -1.49% (0.06), respectively; LSM difference: -0.11% (95% CI: -0.26 to 0.04)]. The incidence and rates of hypoglycaemia were similarly low in both arms: relative risk of confirmed and/or severe nocturnal (00:00-05:59 hours) hypoglycaemia was 0.77 (95% CI: 0.27 to 2.18). No differences were observed for improvement in PROs. No safety concerns were reported.
CONCLUSIONS


In the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.",2020,"At Week 24, HbA 1c  reduction from baseline was non-inferior in patient- vs physician-managed arms","['355 participants were included in the intention-to-treat population', 'Insulin-naïve adults with T2DM for ≥1\u2009year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides', 'People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin', 'insulin-naïve type 2 diabetic subjects', 'naïve patients with uncontrolled T2DM']","['insulin glargine', 'Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin']","['incidence and rates of hypoglycaemia', 'hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs) and adverse events', 'PROs', 'hypoglycaemia', 'change in HbA 1c  ']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",355.0,0.0960344,"At Week 24, HbA 1c  reduction from baseline was non-inferior in patient- vs physician-managed arms","[{'ForeName': 'Riccardo C', 'Initials': 'RC', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases and Department of Medicine and Surgery, University of Parma and AOU of Parma Italy, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Buzzetti', 'Affiliation': 'Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Perseghin', 'Affiliation': 'University of Milan Bicocca, Milan, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Cucinotta', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'University of Padua, Padova, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Aimaretti', 'Affiliation': 'University of the Eastern Piedmont, Vercelli, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Larosa', 'Affiliation': 'Sanofi, Milan, Italy.'}, {'ForeName': 'Carmine G', 'Initials': 'CG', 'LastName': 'Fanelli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3304']
299,32122230,"Vortioxetine as adjunctive therapy to risperidone for treatment of patients with chronic schizophrenia: A randomised, double-blind, placebo-controlled clinical trial.","INTRODUCTION AND OBJECTIVES


Vortioxetine, a novel antidepressant, may be an interesting candidate for adjunctive therapy of schizophrenia. Our primary objective was to investigate the effect of vortioxetine on negative symptoms, with the assessment of positive, general psychopathology and total symptoms as our secondary goal.
METHODS


This was an eight-week randomised, double-blind, placebo-controlled, parallel-group clinical trial, in which 78 inpatients with chronic schizophrenia were stabilised with risperidone (4-6 mg/day) for two months before being assigned to adjunctive vortioxetine (10 mg b.i.d.) or placebo. The patients were assessed using the Positive and Negative Syndrome Scale (PANSS), Extrapyramidal Symptom Rating Scale and Hamilton Depression Rating Scale during the study course. All participants had a PANSS negative symptoms subscale score of ⩾16 at baseline. Sixty-eight patients completed the trial.
RESULTS


Vortioxetine improved the negative symptoms score as the primary outcome and total PANSS score as a secondary outcome significantly better than placebo from baseline to end point at week 8, accompanied by significant time × treatment interactions and effect sizes (negative symptoms: mean difference (95% confidence interval (CI)) = -1.82 (-2.73 to -0.92); total scores: mean difference (95% CI) = -2.09 (-3.16 to -1.01). No significant difference was detected for changes in positive symptoms score or PANSS general psychopathology score as the other secondary outcomes from baseline to end point between the two treatment arms. The incidence of adverse events was comparable between groups.
CONCLUSIONS


This is the first study to provide evidence for the therapeutic effect of vortioxetine on negative symptoms as an adjunctive to treatment with antipsychotics in patients with schizophrenia.",2020,No significant difference was detected for changes in positive symptoms score or PANSS general psychopathology score as the other secondary outcomes from baseline to end point between the two treatment arms.,"['patients with schizophrenia', 'patients with chronic schizophrenia', '78 inpatients with chronic schizophrenia were stabilised with', 'Sixty-eight patients completed the trial']","['placebo', 'risperidone', 'vortioxetine', 'adjunctive vortioxetine', 'Vortioxetine']","['negative symptoms score', 'PANSS negative symptoms subscale score', 'positive symptoms score or PANSS general psychopathology score', 'adverse events', 'Positive and Negative Syndrome Scale (PANSS), Extrapyramidal Symptom Rating Scale and Hamilton Depression Rating Scale', 'total PANSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia (disorder)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",78.0,0.602502,No significant difference was detected for changes in positive symptoms score or PANSS general psychopathology score as the other secondary outcomes from baseline to end point between the two treatment arms.,"[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Moazen-Zadeh', 'Affiliation': 'Psychiatric Research Centre, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Bayanati', 'Affiliation': 'Psychiatric Research Centre, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kimia', 'Initials': 'K', 'LastName': 'Ziafat', 'Affiliation': 'Psychiatric Research Centre, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Rezaei', 'Affiliation': 'Qods Hospital, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Mesgarpour', 'Affiliation': 'National Institute for Medical Research Development (NIMAD), Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Centre, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120909416']
300,32248747,"Characterisation of the pharmacodynamic effects of the P2X7 receptor antagonist JNJ-54175446 using an oral dexamphetamine challenge model in healthy males in a randomised, double-blind, placebo-controlled, multiple ascending dose trial.","BACKGROUND


This is the first report of the pharmacodynamic (PD) effects of the selective, potent and brain-penetrant P2X7 receptor (P2X7R) antagonist JNJ-54175446. Activation of the P2X7R, an adenosine triphosphate-gated ion channel, leads to the production of pro-inflammatory cytokines, which have been linked to neuroinflammation and play a role in the pathogenesis of mood disorders. Previous clinical studies with JNJ-54175446 demonstrated peripheral target engagement of JNJ-54175446 by assessing ex vivo lipopolysaccharide (LPS)-stimulated cytokine production. Blood-brain barrier penetration and a clear dose-receptor occupancy relationship was demonstrated using positron emission tomography.
AIMS


The objectives of this double-blind, placebo-controlled, translational study were to assess the safety and tolerability of administering multiple doses of JNJ-54175446 and to explore its PD effects using a dexamphetamine challenge.
METHODS


Subjects ( N  = 64) were randomised to either JNJ-54175446 (50-450 mg;  n  = 48) or placebo ( n  = 16) and underwent a baseline oral 20 mg dexamphetamine challenge followed by 11 consecutive days q.d. dosing with JNJ-54175446/placebo and a randomised crossover dexamphetamine/placebo challenge.
RESULTS


At all doses tested, JNJ-54175446 was well tolerated and suppressed the ex vivo LPS-induced release of cytokines. At doses ⩾100 mg, JNJ-54175446 attenuated dexamphetamine-induced increases in locomotion and enhanced the mood-elevating effects of dexamphetamine, suggesting that a dose that is approximately twice as high is needed to obtain a central PD response compared to the dose needed for maximum peripheral occupancy.
CONCLUSION


Overall, the observed pharmacological profile of JNJ-54175446 in the dexamphetamine challenge paradigm is compatible with a potential mood-modulating effect.",2020,Previous clinical studies with JNJ-54175446 demonstrated peripheral target engagement of JNJ-54175446 by assessing ex vivo lipopolysaccharide (LPS)-stimulated cytokine production.,"['Subjects ( N \u2009=\u200964', 'healthy males']","['placebo', 'JNJ-54175446 (50-450\u2009mg;  n \u2009=\u200948) or placebo', 'P2X7 receptor antagonist JNJ-54175446', 'baseline oral 20\u2009mg dexamphetamine challenge followed by 11 consecutive days q.d. dosing with JNJ-54175446/placebo', 'dexamphetamine/placebo challenge']","['tolerated and suppressed the ex vivo LPS-induced release of cytokines', 'safety and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0386482', 'cui_str': 'Purinoceptor P2Z'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011812', 'cui_str': 'Dextroamphetamine'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.17899,Previous clinical studies with JNJ-54175446 demonstrated peripheral target engagement of JNJ-54175446 by assessing ex vivo lipopolysaccharide (LPS)-stimulated cytokine production.,"[{'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Recourt', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'van der Aart', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Jacobs', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'de Kam', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research and Development LLC, La Jolla, USA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'van Nueten', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica N.V., Beerse, Belgium.'}, {'ForeName': 'Kawita', 'Initials': 'K', 'LastName': 'Kanhai', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Siebenga', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Paulien', 'Initials': 'P', 'LastName': 'Ravenstijn', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica N.V., Beerse, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Timmers', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica N.V., Beerse, Belgium.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research and Development, a Division of Janssen Pharmaceutica N.V., Beerse, Belgium.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120914206']
301,32248771,Thrombolysis With Alteplase at 0.6 mg/kg for Stroke With Unknown Time of Onset: A Randomized Controlled Trial.,"Background and Purpose- We assessed whether lower-dose alteplase at 0.6 mg/kg is efficacious and safe for acute fluid-attenuated inversion recovery-negative stroke with unknown time of onset. Methods- This was an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients met the standard indication criteria for intravenous thrombolysis other than a time last-known-well >4.5 hours (eg, wake-up stroke). Patients were randomly assigned (1:1) to receive alteplase at 0.6 mg/kg or standard medical treatment if magnetic resonance imaging showed acute ischemic lesion on diffusion-weighted imaging and no marked corresponding hyperintensity on fluid-attenuated inversion recovery. The primary outcome was a favorable outcome (90-day modified Rankin Scale score of 0-1). Results- Following the early stop and positive results of the WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke), this trial was prematurely terminated with 131 of the anticipated 300 patients (55 women; mean age, 74.4±12.2 years). Favorable outcome was comparable between the alteplase group (32/68, 47.1%) and the control group (28/58, 48.3%; relative risk [RR], 0.97 [95% CI, 0.68-1.41];  P =0.892). Symptomatic intracranial hemorrhage within 22 to 36 hours occurred in 1/71 and 0/60 (RR, infinity [95% CI, 0.06 to infinity];  P >0.999), respectively. Death at 90 days occurred in 2/71 and 2/60 (RR, 0.85 [95% CI, 0.06-12.58];  P >0.999), respectively. Conclusions- No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset. The safety of alteplase at 0.6 mg/kg was comparable to that of standard treatment. Early study termination precludes any definitive conclusions. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02002325.",2020,No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset.,"['300 patients (55 women; mean age, 74.4±12.2 years', 'Patients met the standard indication criteria for intravenous thrombolysis other than a time last-known-well >4.5 hours (eg, wake-up stroke', 'Onset']","['MRI-Based Thrombolysis', 'alteplase at 0.6 mg/kg or standard medical treatment if magnetic resonance imaging', 'Methods', 'Conclusions', ' and Purpose', 'Thrombolysis With Alteplase']","['Death', 'Symptomatic intracranial hemorrhage', 'favorable outcome (90-day modified Rankin Scale score of 0-1']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",300.0,0.306085,No difference in favorable outcome was seen between alteplase and control groups among patients with ischemic stroke with unknown time of onset.,"[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Koga', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences (H.Y.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of Data Science (K.A., T.H., M.F-D.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Aoki', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (J.A., K. Kimura).'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'Department of Data Science (K.A., T.H., M.F-D.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Kanzawa', 'Affiliation': 'Department of Stroke Medicine, Institute of Brain and Blood Vessels, Mihara Memorial Hospital, Isesaki (T. Kanzawa).'}, {'ForeName': 'Rei', 'Initials': 'R', 'LastName': 'Kondo', 'Affiliation': 'Department of Neurosurgery, Yamagata City Hospital Saiseikan (R. Kondo).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ohtaki', 'Affiliation': 'Department of Neurosurgery, Obihiro Kosei Hospital (M. Ohtaki).'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Itabashi', 'Affiliation': 'Department of Stroke Neurology, Kohnan Hospital, Sendai (R.I.).'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neurosurgery, Nakamura Memorial Hospital, Sapporo (K. Kamiyama).'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Iwama', 'Affiliation': 'Department of Neurosurgery, Gifu University School of Medicine (T. Iwama).'}, {'ForeName': 'Taizen', 'Initials': 'T', 'LastName': 'Nakase', 'Affiliation': 'Department of Stroke Science, Research Institute for Brain and Blood Vessels, Akita (T.N.).'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yakushiji', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Saga University Faculty of Medicine (Y.Y.).'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Igarashi', 'Affiliation': 'Department of Neurology, Niigata City General Hospital (S.I.).'}, {'ForeName': 'Yoshinari', 'Initials': 'Y', 'LastName': 'Nagakane', 'Affiliation': 'Department of Neurology, Kyoto Second Red Cross Hospital (Y.N.).'}, {'ForeName': 'Shunya', 'Initials': 'S', 'LastName': 'Takizawa', 'Affiliation': 'Division of Neurology, Department of Internal Medicine, Tokai University School of Medicine, Isehara (S.T.).'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Department of Cerebrovascular Medicine and Neurology, Cerebrovascular Center, National Hospital Organization Kyushu Medical Center, Fukuoka (Y.O.).'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Doijiri', 'Affiliation': 'Department of Neurology, Iwate Prefectural Central Hospital, Morioka (R.D.).'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tsujino', 'Affiliation': 'Department of Neurology and Strokology, Nagasaki University Graduate School of Biomedical Sciences (A.T.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Neurology, Toyota Memorial Hospital (Y.I.).'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Neurosurgery, Ohnishi Neurological Center, Akashi (H.O.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Department of Stroke Medicine, Kawasaki Medical School General Medical Center, Okayama (T. Inoue).'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Department of Neurosurgery, Tokushima University (Y.T.).'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Neurology, St. Marianna University School of Medicine, Kawasaki (Y.H.).'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Shiokawa', 'Affiliation': 'Department of Neurosurgery, Kyorin University School of Medicine, Mitaka (Y.S.).'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Sakai', 'Affiliation': 'Department of Neurosurgery, Kobe City Medical Center General Hospital (N.S.).'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Department of Cerebrovascular Medicine, Stroke Center, Steel Memorial Yawata Hospital, Kitakyushu (M.O.).'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Uesaka', 'Affiliation': 'Department of Neurology, Toranomon Hospital, Tokyo (Y.U.).'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'Department of Neurosurgery, Hyogo College of Medicine, Nishinomiya (S. Yoshimura).'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Urabe', 'Affiliation': 'Department of Neurology, Juntendo University Urayasu Hospital (T. Urabe).'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Strokology, Stroke Center, St. Marianna University Toyoko Hospital, Kawasaki (T. Ueda).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ihara', 'Affiliation': 'Department of Neurology (M. Ihara), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka (T. Kitazono).'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Sasaki', 'Affiliation': 'Institute for Biomedical Sciences, Iwate Medical University, Yahaba (M.S.).'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Oita', 'Affiliation': 'Department of Pharmacy (A.O.), National Cerebral and Cardiovascular Center, Suita.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Fukuda-Doi', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Miwa', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Nippon Medical School, Tokyo (J.A., K. Kimura).'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'From the Department of Cerebrovascular Medicine (M.K., M. Inoue, S. Yoshimura, M.F.-D., K. Miwa, K. Minematsu, K. Toyoda).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028127']
302,32251265,Blood-based biomarkers for prediction of intracranial hemorrhage and outcome in patients with moderate or severe traumatic brain injury.,"BACKGROUND


Early identification of traumatic intracranial hemorrhage (ICH) has implications for triage and intervention. Blood-based biomarkers were recently approved by the Food and Drug Administration (FDA) for prediction of ICH in patients with mild traumatic brain injury (TBI). We sought to determine if biomarkers measured early after injury improve prediction of mortality and clinical/radiologic outcomes compared with Glasgow Coma Scale (GCS) alone in patients with moderate or severe TBI (MS-TBI).
METHODS


We measured glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), and microtubule-associated protein-2 (MAP-2) on arrival to the emergency department (ED) in patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS score, 3-12; SPB, > 90). Biomarkers were modeled individually and together with prehospital predictor variables [PH] (GCS score, age, sex). Data were divided into a training data set and test data set for model derivation and evaluation. Models were evaluated for prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended (GOS-E) and Disability Rating Scale (DRS). Area under the curve (AUC) was evaluated in test data for PH alone, PH + individual biomarkers, and PH + three biomarkers.
RESULTS


Of 243 patients with baseline samples (obtained a median of 84 minutes after injury), prehospital GCS score was 8 (interquartile range, 5-10), 55% had ICH, and 48-hour and 28-day mortality were 7% and 13%, respectively. Poor neurologic outcome at 6 months was observed in 34% based on GOS-E of 4 or less, and 24% based on DRS greater than or equal to7. Addition of each biomarker to PH improved AUC in the majority of predictive models. GFAP+PH compared with PH alone significantly improved AUC in all models (ICH, 0.82 vs. 0.64; 48-hour mortality, 0.84 vs. 0.71; 28-day mortality, 0.84 vs. 0.66; GOS-E, 0.78 vs. 0.69; DRS, 0.84 vs. 0.81, all p < 0.001).
CONCLUSION


Circulating blood-based biomarkers may improve prediction of neurological outcomes and mortality in patients with MS-TBI over prehospital characteristics alone. Glial fibrillary acidic protein appears to be the most promising. Future evaluation in the prehospital setting is warranted.
LEVEL OF EVIDENCE


Prospective, Prognostic and Epidemiological, level II.",2020,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001].
","['patients with mild TBI', 'traumatic intracranial hemorrhage (ICH', '243 patients with baseline samples', 'patients with moderate or severe TBI (MS-TBI', 'patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS 3-12, SPB > 90', 'patients with MS-TBI over prehospital characteristics alone']","['GCS', 'GFAP', 'GFAP+PH']","['AUC', 'prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended [GOSE] and Disability Rating Scale [DRS', 'Poor neurologic outcome', 'glial-fibrillary-acidic-protein (GFAP), ubiquitin-C-terminal-hydrolase-L1 (UCH-L1), and microtubule-associated-protein-2 (MAP-2', 'prehospital GCS', 'mortality and clinical/radiologic outcomes', 'ICH, and 48-hr and 28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0273058', 'cui_str': 'Intracranial hemorrhage following injury'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0597729', 'cui_str': 'Spindle Pole Body'}, {'cui': 'C0439083', 'cui_str': '>90'}]","[{'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0164005', 'cui_str': 'Ubiquitin thiolesterase'}, {'cui': 'C1436157', 'cui_str': 'UCHL1 protein, human'}, {'cui': 'C0024773', 'cui_str': 'MAP2 Microtubule-Associated Protein'}, {'cui': 'C1433609', 'cui_str': 'METAP2 protein, human'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]",243.0,0.0609947,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001].
","[{'ForeName': 'Taylor N', 'Initials': 'TN', 'LastName': 'Anderson', 'Affiliation': 'From the School of Medicine (T.N.A.), Department of Neurology (H.E.H.), Department of Surgery (S.E.R.), Oregon Health and Science University, Portland, Oregon; Department of Biostatistics (J.H.), University of Washington, Seattle, Washington; College of Pharmacy (M.M.), Oregon State University, Corvallis, Oregon; Department of Emergency Medicine (L.P.), Orlando Regional Medical Center, Orlando, Florida; Department of Surgery (A.V.), Mercer University School of Medicine, Macon, Georgia; and Department of Surgery (S.E.R.), Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Munar', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002706']
303,32251368,Gait rehabilitation in persons with spinal cord injury using innovative technologies: an observational study.,"STUDY DESIGN


Prospective, quasi-experimental study, pre- and post-design, single arm study.
OBJECTIVES


Investigate whether persons affected by SCI can safely experience walking function using Robotic Exoskeletons and Functional Electrical Stimulation (FES).
SETTING


Inpatient METHODS: 52 persons with SCI were recruited (36 completed the protocol) and assigned to one of two groups based on their Lower Limb Motor Scores (LEMS): Group A: LEMS ≥ 10 and Group B: LEMS < 10. Participants in Group A (n = 19) underwent 20 sessions of Robot-Assisted Gait Training (RAGT) on a treadmill followed by 20 sessions of FES during Overground Gait (FES-OG). Participants in Group B (n = 17) received 20 sessions of FES-cycling followed by 20 sessions of overground RAGT. The main outcome measures were: WISCI-II, 10MWT, 6MWT, TUG and SCIM-II.
RESULTS


36 persons completed the study with no complications; only 4 of the 16 dropped out because of mild complications during the RAGT. Participants in Group A exhibited significant improvements in WISCI-II, 10MWT, 6MWT and TUG (p < 0.05), while those in Group B did not significantly improve their gait function but their walking velocity and resistance with the assistance of the robotic exoskeleton increased. SCIM-II scores increased followed therapy only in Group A.
CONCLUSIONS


Persons affected by SCI can safely experience their walking function with RAGT and FES therapy; only few mild complications were observed. Our data provides initial evidence of the potential value of these technologies, especially in persons with SCI having LEMS > 10.",2020,"Participants in Group A exhibited significant improvements in WISCI-II, 10MWT, 6MWT and TUG (p < 0.05), while those in Group B did not significantly improve their gait function but their walking velocity and resistance with the assistance of the robotic exoskeleton increased.","['36 persons', '52 persons with SCI', 'persons with spinal cord injury using innovative technologies', 'persons with SCI having LEMS\u2009>\u200910']","['Gait rehabilitation', 'Robotic Exoskeletons and Functional Electrical Stimulation (FES', '20 sessions of FES-cycling followed by 20 sessions of overground RAGT', 'Robot-Assisted Gait Training (RAGT']","['mild complications', 'WISCI-II, 10MWT, 6MWT and TUG', 'Limb Motor Scores (LEMS', 'WISCI-II, 10MWT, 6MWT, TUG and SCIM-II', 'gait function', 'SCIM-II scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4046099', 'cui_str': 'Robotic Exoskeleton'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0115922', 'cui_str': 'endogenous pyrogen'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",52.0,0.0176092,"Participants in Group A exhibited significant improvements in WISCI-II, 10MWT, 6MWT and TUG (p < 0.05), while those in Group B did not significantly improve their gait function but their walking velocity and resistance with the assistance of the robotic exoskeleton increased.","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Stampacchia', 'Affiliation': 'Spinal Cord Unit, Pisa University Hospital, Pisa, Italy. g.stampacchia@ao-pisa.toscana.it.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Olivieri', 'Affiliation': 'Spinal Cord Unit, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rustici', 'Affiliation': 'Spinal Cord Unit, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': ""D'Avino"", 'Affiliation': 'Spinal Cord Unit, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Gerini', 'Affiliation': 'Spinal Cord Unit, Pisa University Hospital, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mazzoleni', 'Affiliation': ""The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.""}]",Spinal cord,['10.1038/s41393-020-0454-2']
304,31573637,Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial.,"Importance


Experimental data suggest that intravenous vitamin C may attenuate inflammation and vascular injury associated with sepsis and acute respiratory distress syndrome (ARDS).
Objective


To determine the effect of intravenous vitamin C infusion on organ failure scores and biological markers of inflammation and vascular injury in patients with sepsis and ARDS.
Design, Setting, and Participants


The CITRIS-ALI trial was a randomized, double-blind, placebo-controlled, multicenter trial conducted in 7 medical intensive care units in the United States, enrolling patients (N = 167) with sepsis and ARDS present for less than 24 hours. The study was conducted from September 2014 to November 2017, and final follow-up was January 2018.
Interventions


Patients were randomly assigned to receive intravenous infusion of vitamin C (50 mg/kg in dextrose 5% in water, n = 84) or placebo (dextrose 5% in water only, n = 83) every 6 hours for 96 hours.
Main Outcomes and Measures


The primary outcomes were change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 96 hours, and plasma biomarkers of inflammation (C-reactive protein levels) and vascular injury (thrombomodulin levels) measured at 0, 48, 96, and 168 hours.
Results


Among 167 randomized patients (mean [SD] age, 54.8 years [16.7]; 90 men [54%]), 103 (62%) completed the study to day 60. There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (from 9.8 to 6.8 in the vitamin C group [3 points] and from 10.3 to 6.8 in the placebo group [3.5 points]; difference, -0.10; 95% CI, -1.23 to 1.03; P = .86) or in C-reactive protein levels (54.1 vs 46.1 μg/mL; difference, 7.94 μg/mL; 95% CI, -8.2 to 24.11; P = .33) and thrombomodulin levels (14.5 vs 13.8 ng/mL; difference, 0.69 ng/mL; 95% CI, -2.8 to 4.2; P = .70) at 168 hours.
Conclusions and Relevance


In this preliminary study of patients with sepsis and ARDS, a 96-hour infusion of vitamin C compared with placebo did not significantly improve organ dysfunction scores or alter markers of inflammation and vascular injury. Further research is needed to evaluate the potential role of vitamin C for other outcomes in sepsis and ARDS.
Trial Registration


ClinicalTrials.gov Identifier: NCT02106975.",2019,"There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (from 9.8 to 6.8 in the vitamin C group [3 points] and from 10.3 to 6.8 in the placebo group [3.5 points]; difference, -0.10; 95% CI, -1.23 to 1.03; P = .86) or in C-reactive protein levels (54.1 vs 46.1 μg/mL; difference, 7.94 μg/mL; 95% CI, -8.2 to 24.11;","['167 randomized patients (mean [SD] age, 54.8 years [16.7', 'Patients With Sepsis and Severe Acute Respiratory Failure', 'patients with sepsis and ARDS', '7 medical intensive care units in the United States, enrolling patients (N\u2009=\u2009167) with sepsis and ARDS present for less than 24 hours', 'September 2014 to November 2017, and final follow-up was January 2018', ' 90 men [54%]), 103 (62%) completed the study to day 60']","['vitamin C infusion', 'vitamin C', 'Vitamin C Infusion', 'placebo', 'intravenous vitamin C', 'intravenous infusion of vitamin C (50 mg/kg in dextrose 5% in water, n\u2009=\u200984) or placebo (dextrose']","['mean modified Sequential Organ Failure Assessment score', 'C-reactive protein levels', 'change in organ failure as assessed by a modified Sequential Organ Failure Assessment score (range, 0-20, with higher scores indicating more dysfunction) from baseline to 96 hours, and plasma biomarkers of inflammation (C-reactive protein levels) and vascular injury (thrombomodulin levels', 'organ failure scores and biological markers of inflammation and vascular injury', 'Organ Failure and Biomarkers of Inflammation and Vascular Injury', 'organ dysfunction scores', 'thrombomodulin levels']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C2711734', 'cui_str': 'Medical intensive care unit'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0178324', 'cui_str': 'Vascular Injuries'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C3494458', 'cui_str': 'Organ Dysfunction Scores'}]",167.0,0.786719,"There were no significant differences between the vitamin C and placebo groups in the primary end points of change in mean modified Sequential Organ Failure Assessment score from baseline to 96 hours (from 9.8 to 6.8 in the vitamin C group [3 points] and from 10.3 to 6.8 in the placebo group [3.5 points]; difference, -0.10; 95% CI, -1.23 to 1.03; P = .86) or in C-reactive protein levels (54.1 vs 46.1 μg/mL; difference, 7.94 μg/mL; 95% CI, -8.2 to 24.11;","[{'ForeName': 'Alpha A', 'Initials': 'AA', 'LastName': 'Fowler', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Jonathon D', 'Initials': 'JD', 'LastName': 'Truwit', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'R Duncan', 'Initials': 'RD', 'LastName': 'Hite', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Morris', 'Affiliation': 'University of Kentucky, Lexington.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'DeWilde', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Priday', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Fisher', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Natarajan', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Donald F', 'Initials': 'DF', 'LastName': 'Brophy', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Sculthorpe', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Nanchal', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Aamer', 'Initials': 'A', 'LastName': 'Syed', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Sturgill', 'Affiliation': 'University of Kentucky, Lexington.'}, {'ForeName': 'Greg S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sevransky', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Markos', 'Initials': 'M', 'LastName': 'Kashiouris', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Hamman', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Katherine F', 'Initials': 'KF', 'LastName': 'Egan', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Hastings', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Spencer', 'Affiliation': 'Fairview Hospital, Cleveland, Ohio.'}, {'ForeName': 'Shawnda', 'Initials': 'S', 'LastName': 'Tench', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mehkri', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bindas', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Graf', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Zellner', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Yanny', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'McPolin', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Hollrith', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kramer', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ojielo', 'Affiliation': 'Froedtert Hospital and the Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Damm', 'Affiliation': ""Aurora St. Luke's Medical Center, Milwaukee, Wisconsin.""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Cassity', 'Affiliation': 'University of Kentucky, Lexington.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Wieliczko', 'Affiliation': 'University of Kentucky, Lexington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Halquist', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}]",JAMA,['10.1001/jama.2019.11825']
305,31006684,Recruitment of Older Veterans with Diabetes Risk for Alzheimer's Disease for a Randomized Clinical Trial of Computerized Cognitive Training.,"BACKGROUND


Type 2 diabetes mellitus (T2DM) is prevalent in the general United States population, and in the veteran population. T2DM has consistently been linked to increased risk for cognitive impairment, dementia, and Alzheimer's disease. Computerized cognitive training (CCT) is practical and inexpensive cognitive interventions that is an alternative to medication.
OBJECTIVE


To report the recruitment methods and challenges to date in an ongoing two-site randomized controlled trial (RCT) of CCT on cognitive function and T2DM management in an older non-demented veteran population.
METHODS


Veterans are recruited primarily by targeted mailings or by direct contact at clinics and presentations.
RESULTS


From 1,459 original contacts, 437 expressed initial interest, 111 provided informed consent, and 97 completed baseline assessments. Participants from the two VA Medical Centers differed in demographics and baseline characteristics. Comparing recruitment methods, the proportion of individuals contacted who were ultimately consented was significantly less from mailings (5%) than other sources (20%), primarily face- to-face clinic visits (χ2 (1) = 38.331, p < 0.001).
CONCLUSIONS


Mailings are cost-effective, but direct contact improved recruitment. Not using or lacking access to computers and ineligibility were major reasons for non-participation. Within-site comparisons of demographically diverse sites can address confounding of demographic and other site differences.",2019,"Comparing recruitment methods, the proportion of individuals contacted who were ultimately consented was significantly less from mailings (5%) than other sources (20%), primarily face- to-face clinic visits (χ2 (1) = 38.331, p < 0.001).
","[""Older Veterans with Diabetes Risk for Alzheimer's Disease"", 'Veterans are recruited primarily by targeted mailings or by direct contact at clinics and presentations', 'older non-demented veteran population']","['Computerized Cognitive Training', 'CCT', 'Computerized cognitive training (CCT']","['cognitive function and T2DM management', 'primarily face- to-face clinic visits']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0449450', 'cui_str': 'Presentation (attribute)'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",,0.113789,"Comparing recruitment methods, the proportion of individuals contacted who were ultimately consented was significantly less from mailings (5%) than other sources (20%), primarily face- to-face clinic visits (χ2 (1) = 38.331, p < 0.001).
","[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Karran', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Guerrero-Berroa', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schmeidler', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Pearl G', 'Initials': 'PG', 'LastName': 'Lee', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Nabozny', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'West', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Michal Schnaider', 'Initials': 'MS', 'LastName': 'Beeri', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sano', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Silverman', 'Affiliation': 'James J. Peters Veterans Affairs Medical Center, Bronx, NY, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180952']
306,31331803,"Efficacy of Guided Imagery for Postoperative Symptoms, Sleep Quality, Anxiety, and Satisfaction Regarding Nursing Care: A Randomized Controlled Study.","PURPOSE


The purpose of this study was to determine the effects of perioperatively applied guided imagery on nausea, satisfaction, and anxiety.
DESIGN


This is a prospective randomized controlled study.
METHODS


In addition to standard treatment and nursing care, guided imagery was applied to the intervention group once in the preoperative period, once on the first day of postoperative period, twice in the second and third days, for six times in total. Only standard treatment and nursing care were given to the patients of the control group.
FINDINGS


Anxiety and intensity of pain were significantly higher in the control group than the intervention group, and the level of satisfaction and sleep quality were lower in the control group than the intervention group.
CONCLUSIONS


Results support that guided imagery can be useful in improving perianesthetic symptoms and can be a part of nursing care.",2019,"FINDINGS


Anxiety and intensity of pain were significantly higher in the control group than the intervention group, and the level of satisfaction and sleep quality were lower in the control group than the intervention group.
",[],"['perioperatively applied guided imagery', 'Guided Imagery']","['Postoperative Symptoms, Sleep Quality, Anxiety, and Satisfaction Regarding Nursing Care', 'nausea, satisfaction, and anxiety', 'perianesthetic symptoms', 'level of satisfaction and sleep quality', 'Anxiety and intensity of pain']",[],"[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.023912,"FINDINGS


Anxiety and intensity of pain were significantly higher in the control group than the intervention group, and the level of satisfaction and sleep quality were lower in the control group than the intervention group.
","[{'ForeName': 'Kadriye', 'Initials': 'K', 'LastName': 'Acar', 'Affiliation': ''}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Aygin', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.05.006']
307,32249193,Randomized Comparison of Prostatic Artery Embolization versus Transurethral Resection of the Prostate for Treatment of Benign Prostatic Hyperplasia.,"PURPOSE


To compare clinical and functional outcomes of prostatic artery embolization (PAE) with those of transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
MATERIALS AND METHODS


Noninferiority randomized trial was conducted involving men over 60 years of age with LUTS secondary to BPH. From November 2014 to January 2017, 45 patients were randomized to PAE (n = 23) or to TURP (n = 22). PAE was performed with 300- to 500-μm microspheres with the patient under local anesthesia, whereas bipolar TURP was performed with the patients under spinal or general anesthesia. Primary outcomes were changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS) from baseline to 12 months. Quality of life (QoL), and prostate volume (PV) changes from baseline to 12 month were secondary outcomes. Adverse events were compared using the Clavien classification.
RESULTS


Mean Q max  increased from 6.1 mL/s in the PAE group and from 9.6 mL/s in the TURP patients (P = .862 for noninferiority), and mean IPSS reduction was 21.0 points for PAE and 18.2 points for TURP subjects (P = .080) at 12 months. A greater QoL improvement was reported in the PAE group (3.78 points for PAE and 3.09 points for TURP; P = .002). Mean PV reduction was 20.5 cm³ (34.2%) for PAE subjects and 44.7 cm³ (71.2%) for TURP subjects (P < .001). There were fewer adverse events reported in the PAE group than in the TURP group (n = 15 vs n = 47; P < .001).
CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE. Long-term follow-up is needed to compare the durability of the symptomatic improvement from each procedure.",2020,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","['Benign Prostatic Hyperplasia', 'lower urinary symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH', 'men over 60 years of age with LUTS secondary to BPH', 'From November 2014 to January 2017, 45 patients']","['prostatic artery embolization (PAE', 'TURP', 'Prostatic Artery Embolization versus Transurethral Resection', 'transurethral resection of the prostate (TURP', 'PAE']","['changes in peak urinary flow (Q max ) and international prostate symptoms score (IPSS', 'QoL improvement', 'mean IPSS reduction', 'adverse events', 'Quality of life (QoL), and prostate volume (PV) changes', 'Adverse events', 'Mean PV reduction', 'Mean Q max']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0429549,"CONCLUSIONS


Reduction of LUTS in the PAE group was similar to that in the TURP group at 12 months, with fewer complications secondary to PAE.","[{'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Insausti', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain. Electronic address: insausti00@hotmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sáez de Ocáriz', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra-Universidad Pública de Navarra, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Pamplona, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Capdevila', 'Affiliation': 'Department of Pharmacy, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saioa', 'Initials': 'S', 'LastName': 'Solchaga', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Giral', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Bilhim', 'Affiliation': 'Department of Interventional Radiology, Hospital St. Louis, Lisbon, Portugal; Department of Radiology, NOVA Medical School, Lisbon, Portugal; Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Isaacson', 'Affiliation': 'Division of Vascular and Interventional Radiology, Department of Radiology, University of North Carolina Medical Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Urtasun', 'Affiliation': 'Department of Interventional Radiology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Saturnino', 'Initials': 'S', 'LastName': 'Napal', 'Affiliation': 'Department of Urology, Complejo Hospitalario de Navarra, Pamplona, Spain.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.12.810']
308,32239190,Effect of Adjuvant Topical Dorzolamide-Timolol vs Placebo in Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.,"Importance


Some eyes with neovascular age-related macular degeneration (AMD) have persistent exudation despite frequent intravitreal anti-vascular endothelial growth factor (VEGF) injections. Adjuvant therapies that further reduce edema may improve vision outcomes.
Objective


To compare the short-term effect of topical dorzolamide-timolol vs placebo in eyes with neovascular AMD that have persistent exudation following intravitreal anti-VEGF injections.
Design, Setting, and Participants


Randomized placebo-controlled clinical trial with enrollment from March 1, 2017, through October 30, 2018. Multicenter trial at 4 clinical sites in the United States. Sixty-three patients with neovascular AMD who had persistent exudation despite intravitreal anti-VEGF injections at 4-week, 5-week, or 6-week intervals.
Interventions


Patients were randomized to use dorzolamide-timolol or artificial tears for the study duration. They continued to receive the same anti-VEGF drug at the same interval as the 2 visits before enrollment for 3 additional study visits.
Main Outcomes and Measures


The primary outcome measure was change in mean central subfield thickness on optical coherence tomography from baseline to visit 3 (approximately 3 months). Secondary measures included change in mean maximum subretinal fluid height, mean maximum pigment epithelial detachment height, and mean visual acuity (VA).
Results


This trial included 52 patients. All 27 patients (100%) assigned to dorzolamide-timolol and 23 of 25 (92%) assigned to placebo were analyzed for the primary outcome. Mean (SD) age was 78.4 (7) years, and 34 of 50 patients (68%) were women. Mean (SD) injections were 20.5 (14) (range, 4-58) before enrollment. Mean (SD) baseline logMAR VA was 0.361 (0.26) (approximate Snellen equivalent, 20/50). Comparing the dorzolamide-timolol with placebo group from baseline to visit 3, mean (SD) change in central subfield thickness (primary outcome) was -36.6 (54) μm vs 1.7 (52.3) μm (difference, 30.8; 95% CI, 0.3-61.3; P = .04); secondary outcomes: maximum PED height was -39.1 (65) μm vs 1.1 (16) μm (difference, 39.6; 95% CI, 9.6-69.6; P = .01) and change in VA from baseline to visit 3 was -2.3 (5) vs 0.3 (1) letters (difference, 2.6 letters; 95% CI, -1.9 to 7.1 letters; P = .78).
Conclusions and Relevance


These findings suggest use of dorzolamide-timolol in patients with neovascular AMD with persistent exudation resulted in anatomic but not visual acuity improvements compared with placebo at approximately 3 months. Additional clinical trials with longer follow-up and larger sample sizes presumably would be needed to determine the role, if any, of dorzolamide-timolol in neovascular AMD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03034772.",2020,"(difference, 30.8; 95% CI, 0.3-61.3; P = .04);","['Sixty-three patients with neovascular AMD who had persistent exudation despite', 'Mean (SD) age was 78.4 (7) years, and 34 of 50 patients (68%) were women', '52 patients', 'eyes with neovascular AMD', 'patients with neovascular AMD', 'Neovascular Age-Related Macular Degeneration', 'eyes with neovascular age-related macular degeneration (AMD', 'Multicenter trial at 4 clinical sites in the United States']","['topical dorzolamide-timolol vs placebo', 'placebo', 'Adjuvant Topical Dorzolamide-Timolol vs Placebo', 'dorzolamide-timolol', 'intravitreal anti-VEGF injections']","['Mean (SD) baseline logMAR VA', 'maximum PED height', 'visual acuity improvements', 'mean (SD) change in central subfield thickness', 'change in mean maximum subretinal fluid height, mean maximum pigment epithelial detachment height, and mean visual acuity (VA', 'mean central subfield thickness on optical coherence tomography', 'Mean (SD) injections']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0311437', 'cui_str': 'Exudation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C1721343', 'cui_str': 'Dorzolamide- and timolol-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0339546', 'cui_str': 'Retinal pigment epithelial detachment'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",52.0,0.668099,"(difference, 30.8; 95% CI, 0.3-61.3; P = .04);","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Samir N', 'Initials': 'SN', 'LastName': 'Patel', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Wolfe', 'Affiliation': 'Associated Retinal Consultants, William Beaumont Hospital, Royal Oak, Michigan.'}, {'ForeName': 'Chirag P', 'Initials': 'CP', 'LastName': 'Shah', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Jenkins', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Turner D', 'Initials': 'TD', 'LastName': 'Wibbelsman', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Obeid', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Associated Retinal Consultants, William Beaumont Hospital, Royal Oak, Michigan.'}, {'ForeName': 'Sunir J', 'Initials': 'SJ', 'LastName': 'Garg', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Ho', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Chiang', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Spirn', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Vander', 'Affiliation': 'The Retina Service of Wills Eye Hospital, Mid Atlantic Retina, Philadelphia, Pennsylvania.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0724']
309,32160632,Comparison of the Effectiveness of Universal and Targeted Iodine Supplementation in Pregnant Women: A Randomized Controlled Trial.,"OBJECTIVE


To compare the effectiveness of universal and targeted iodine supplementation strategies.
METHODS


A randomized controlled trial involving low-risk Thai pregnant women was carried out. The participants were categorized into either the study group, in which iodine supplementation was varied based on median urine iodine concentration, or the control group, which received universal supplementation. Urine samples were collected before the start of treatment and at delivery. The primary outcome was iodine status after each supplementation regime.
RESULTS


Two hundred and eight women were randomly categorized into 2 groups, 104 control-group participants and 104 study-group participants. Baseline iodine status in both groups was not significantly different. More than half of the pregnant women were classified as having iodine insufficiency. After supplementation, the proportions of iodine insufficiency in the control and study groups (27.9 and 33.3%, respectively; p value = 0.508) and those of excessive level (19.1 and 11.7%, respectively; p value = 0.247) were not significantly different between the 2 groups. However, iodine level above the requirement was statistically significantly higher in the control group (47.1%) compared with the study group (30.0%; p value = 0.048).
CONCLUSIONS


The 2 strategies, universal and targeted supplementation, have comparable effectiveness in prevention of iodine deficiency, but the evidence suggests that targeted supplementation is better in avoiding over-supplementation.",2020,"However, iodine level above the requirement was statistically significantly higher in the control group (47.1%) compared with the study group (30.0%; p value = 0.048).
","['Two hundred and eight women were randomly categorized into 2 groups, 104 control-group participants and 104 study-group participants', 'low-risk Thai pregnant women', 'Pregnant Women']","['universal supplementation', 'iodine supplementation', 'Universal and Targeted Iodine Supplementation']","['iodine level', 'excessive level', 'proportions of iodine insufficiency', 'iodine status after each supplementation regime', 'Baseline iodine status']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",208.0,0.081889,"However, iodine level above the requirement was statistically significantly higher in the control group (47.1%) compared with the study group (30.0%; p value = 0.048).
","[{'ForeName': 'Tugsina', 'Initials': 'T', 'LastName': 'Tinna', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Sakaewan', 'Initials': 'S', 'LastName': 'Ounjaijean', 'Affiliation': 'Research Institute for Health Sciences Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Theera', 'Initials': 'T', 'LastName': 'Tongsong', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Kuntharee', 'Initials': 'K', 'LastName': 'Traisrisilp', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand, kuntharee.t@cmu.ac.th.'}]",Gynecologic and obstetric investigation,['10.1159/000506800']
310,31744312,Reconsidering Dexmedetomidine for Sedation in the Critically Ill: Implications of the SPICE III Trial.,"Dexmedetomidine is a sedative agent that has gained popularity for use in the intensive care unit over the past 20 years. Guidelines recommend dexmedetomidine as a first-line agent to achieve light sedation in mechanically ventilated adults. Recently, the SPICE III (Sedation Practice in Intensive Care Evaluation III) trial was published. This was a randomized controlled trial comparing initial sedation with dexmedetomidine with usual care sedation in adult patients receiving mechanical ventilation. The results of this trial have both validated and contradicted previous findings about dexmedetomidine. This editorial examines the merits of the SPICE III trial and the role of dexmedetomidine in practice following its publication.",2020,This was a randomized controlled trial comparing initial sedation with dexmedetomidine with usual care sedation in adult patients receiving mechanical ventilation.,"['mechanically ventilated adults', 'adult patients receiving mechanical ventilation', 'Sedation in the Critically Ill']","['Reconsidering Dexmedetomidine', 'dexmedetomidine', 'Dexmedetomidine']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.0709695,This was a randomized controlled trial comparing initial sedation with dexmedetomidine with usual care sedation in adult patients receiving mechanical ventilation.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Farina', 'Affiliation': 'Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Alaniz', 'Affiliation': 'Michigan Medicine, Ann Arbor, MI, USA.'}]",The Annals of pharmacotherapy,['10.1177/1060028019890672']
311,30661836,"An observer blinded, randomized, placebo-controlled, phase I dose escalation trial to evaluate the safety and immunogenicity of an inactivated West Nile virus Vaccine, HydroVax-001, in healthy adults.","BACKGROUND


West Nile virus (WNV) is the most common mosquito-borne infection in the United States. HydroVax-001 WNV is a hydrogen peroxide inactivated, whole virion (WNV-Kunjin strain) vaccine adjuvanted with aluminum hydroxide.
METHODS


We performed a phase 1, randomized, placebo-controlled, double-blind (within dosing group), dose escalation clinical trial of the HydroVax-001 WNV vaccine administered via intramuscular injection. This trial evaluated 1 mcg and 4 mcg dosages of HydroVax-001 WNV vaccine given intramuscularly on day 1 and day 29 in healthy adults. The two dosing groups of HydroVax-001 were enrolled sequentially and each group consisted of 20 individuals who received HydroVax-001 and 5 who received placebo. Safety was assessed at all study days (days 1, 2, 4 and 15 post dose 1, and days 1, 2, 4, 15, 29, 57, 180 and 365 post dose 2), and reactogenicity was assessed for 14 days after administration of each dose. Immunogenicity was measured by WNV-specific plaque reduction neutralization tests (PRNT 50 ) in the presence or absence of added complement or by WNV-specific enzyme-linked immunosorbent assays (ELISA).
RESULTS


HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT 50  but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added complement, PRNT 50  seroconversion rates increased to 50%, and 75% seroconversion was observed by WNV-specific ELISA.
CONCLUSIONS


The HydroVax-001 WNV vaccine was found to be modestly immunogenic and well-tolerated at all dose levels.",2019,"RESULTS


HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals.",['healthy adults'],"['placebo', 'HydroVax-001 WNV vaccine', 'HydroVax-001', 'HydroVax-001 and 5 who received placebo', 'inactivated West Nile virus Vaccine, HydroVax-001', 'aluminum hydroxide']","['HydroVax-001 elicited neutralizing antibody responses', 'Immunogenicity', 'seroconversion rates', 'reactogenicity', 'modestly immunogenic and well-tolerated', 'safety and immunogenicity', 'safe and well-tolerated', 'Safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1299874', 'cui_str': 'West Nile Virus Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.307203,"RESULTS


HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals.","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Woods', 'Affiliation': 'Duke Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: chris.woods@duke.edu.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Sanchez', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Duke Department of Gynecology and Obstetrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Micah T', 'Initials': 'MT', 'LastName': 'McClain', 'Affiliation': 'Duke Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Harrington', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Duke Early Phase Research Unit, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Poore', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Slifka', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Danae E', 'Initials': 'DE', 'LastName': 'Poer DeRaad', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Amanna', 'Affiliation': 'Najít Technologies Inc., Beaverton, OR, USA.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Slifka', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Oregon Health & Science University, Beaverton, OR, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'National Institutes of Health, Division of Microbiology and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Venus', 'Initials': 'V', 'LastName': 'Shahamatdar', 'Affiliation': 'National Institutes of Health, Division of Microbiology and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Amegashie', 'Affiliation': 'Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}]",Vaccine,['10.1016/j.vaccine.2018.12.026']
312,31280990,A Randomized Controlled Trial to Compare Pain Medications in Children Undergoing Strabismus Surgery.,"PURPOSE


The purpose of this study was to investigate optimal intraoperative combinations of analgesia for children undergoing strabismus surgery.
DESIGN


A randomized controlled trial was employed to compare the difference in pain after administration of hydromorphone versus fentanyl.
METHODS


Participants were randomly assigned to either arm of the study. Pain was measured by the revised Faces, Legs, Activity, Cry, and Consolability Scale (rFLACC) tool postoperatively, and the parent was asked about the presence or absence of pain after discharge.
FINDINGS


A total of 135 children were included in the study. The rFLACC pain score was found to be significantly higher postoperatively among patients receiving fentanyl (P = .011). Pain after discharge was reported more often among patients who received fentanyl (P < .001).
CONCLUSIONS


Results of this study can be used to change practice to minimize the pain levels both postoperatively and after discharge for children undergoing strabismus surgery.",2019,The rFLACC pain score was found to be significantly higher postoperatively among patients receiving fentanyl (P = .011).,"['children undergoing strabismus surgery', 'Children Undergoing Strabismus Surgery', 'A total of 135 children were included in the study', 'Participants']","['hydromorphone', 'Pain Medications', 'analgesia']","['Pain', 'revised Faces, Legs, Activity, Cry, and Consolability Scale (rFLACC) tool postoperatively', 'pain', 'rFLACC pain score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1705868', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",135.0,0.284181,The rFLACC pain score was found to be significantly higher postoperatively among patients receiving fentanyl (P = .011).,"[{'ForeName': 'Hasima', 'Initials': 'H', 'LastName': 'Hajdini', 'Affiliation': ''}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Steurer', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Balakas', 'Affiliation': ''}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Ercole', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.01.012']
313,31280991,Preoperative Blindfold Training Prevents Pediatric Psychological Behavior Disorders During the Anesthesia Recovery Period: A Randomized Controlled Trial.,"PURPOSE


To identify the effectiveness and feasibility of blindfold training on preventing pediatric psychological behavior disorders during the anesthesia recovery period.
DESIGN


This study investigated the effect of blindfold training through the assessment of anxiety, delirium, and pain in children during the anesthesia recovery period.
METHODS


This study was a prospective, randomized, controlled trial. Pediatric patients were randomized into either a control (routine practice) or blindfold training group (routine practice + blindfold training). Anxiety, delirium, and pain levels of children were assessed by the modified Yale Preoperative Anxiety Scale, Pediatric Anesthesia Emergence Delirium scale, and the Face, Legs, Activity, Cry, Consolability scale.
FINDINGS


The blindfold training group had significantly lower scores for emergence delirium, anxiety, and pain during the anesthesia recovery period and a lower incidence of anesthesia complications (all P's < .05).
CONCLUSIONS


Preoperative blindfold training was able to reduce anxiety, pain, and the incidence of delirium during the anesthesia recovery period in pediatric patients.",2019,"The blindfold training group had significantly lower scores for emergence delirium, anxiety, and pain during the anesthesia recovery period and a lower incidence of anesthesia complications (all P's < .05).
","['children during the anesthesia recovery period', 'Pediatric patients', 'pediatric patients']","['Preoperative Blindfold Training', 'Preoperative blindfold training', 'control (routine practice) or blindfold training group (routine practice\xa0+\xa0blindfold training', 'blindfold training']","['Pediatric Psychological Behavior Disorders', 'anxiety, delirium, and pain', 'Anxiety, delirium, and pain levels of children', 'emergence delirium, anxiety, and pain during the anesthesia recovery period and a lower incidence of anesthesia complications', 'anxiety, pain, and the incidence of delirium', 'modified Yale Preoperative Anxiety Scale, Pediatric Anesthesia Emergence Delirium scale, and the Face, Legs, Activity, Cry, Consolability scale', 'pediatric psychological behavior disorders']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002908', 'cui_str': 'Anesthesia Recovery Period'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0002908', 'cui_str': 'Anesthesia Recovery Period'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}]",,0.0337191,"The blindfold training group had significantly lower scores for emergence delirium, anxiety, and pain during the anesthesia recovery period and a lower incidence of anesthesia complications (all P's < .05).
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhuang', 'Affiliation': ''}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Mingjing', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zhenyan', 'Initials': 'Z', 'LastName': 'Bo', 'Affiliation': ''}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.03.016']
314,31303389,Acupressure on Anxiety and Sleep Quality After Cardiac Surgery: A Randomized Controlled Trial.,"PURPOSE


To determine the effect of acupressure on anxiety and sleep quality after cardiac surgery.
DESIGN


A randomized pre-post test control group design.
METHODS


Patients after cardiac surgery were divided into two groups: the intervention group (n = 50), who received acupressure on four different acupoints plus standard care, and the control group (n = 50), who received only standard care. Patients were admitted to the surgical clinic from the intensive care unit after 3 or 4 days of surgery. The levels of anxiety and sleep quality were evaluated during three postoperative days starting from their first day in the surgical clinic.
FINDINGS


Among the patients in the intervention group, the usage of acupressure decreased the level of anxiety and increased the sleep quality significantly compared with the control group (P < .05).
CONCLUSIONS


Our findings showed that acupressure decreased the level of anxiety and improved the sleep quality in the surgical clinic after cardiac surgery.",2019,"Among the patients in the intervention group, the usage of acupressure decreased the level of anxiety and increased the sleep quality significantly compared with the control group (P < .05).
","['Patients after cardiac surgery', 'Patients were admitted to the surgical clinic from the intensive care unit after 3 or 4 days of surgery']","['acupressure', 'Acupressure', 'acupressure on four different acupoints plus standard care, and the control group (n = 50), who received only standard care']","['anxiety and sleep quality', 'levels of anxiety and sleep quality', 'level of anxiety', 'Anxiety and Sleep Quality', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",,0.0408129,"Among the patients in the intervention group, the usage of acupressure decreased the level of anxiety and increased the sleep quality significantly compared with the control group (P < .05).
","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Aygin', 'Affiliation': ''}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.03.014']
315,32240532,Is Protocolised Weaning that Includes Early Extubation Onto Non-Invasive Ventilation More Cost Effective Than Protocolised Weaning Without Non-Invasive Ventilation? Findings from the Breathe Study.,"BACKGROUND


Optimising techniques to wean patients from invasive mechanical ventilation (IMV) remains a key goal of intensive care practice. The use of non-invasive ventilation (NIV) as a weaning strategy (transitioning patients who are difficult to wean to early NIV) may reduce mortality, ventilator-associated pneumonia and intensive care unit (ICU) length of stay.
OBJECTIVES


Our objectives were to determine the cost effectiveness of protocolised weaning, including early extubation onto NIV, compared with weaning without NIV in a UK National Health Service setting.
METHODS


We conducted an economic evaluation alongside a multicentre randomised controlled trial. Patients were randomised to either protocol-directed weaning from mechanical ventilation or ongoing IMV with daily spontaneous breathing trials. The primary efficacy outcome was time to liberation from ventilation. Bivariate regression of costs and quality-adjusted life-years (QALYs) provided estimates of the incremental cost per QALY and incremental net monetary benefit (INMB) overall and for subgroups [presence/absence of chronic obstructive pulmonary disease (COPD) and operative status]. Long-term cost effectiveness was determined through extrapolation of survival curves using flexible parametric modelling.
RESULTS


NIV was associated with a mean INMB of £620 ($US885) (cost-effectiveness threshold of £20,000 per QALY) with a corresponding probability of 58% that NIV is cost effective. The probability that NIV is cost effective was higher for those with COPD (84%). NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained).
CONCLUSIONS


The probability of NIV being cost effective relative to weaning without NIV ranged between 57 and 59% overall and between 82 and 87% for the COPD subgroup.",2020,"NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained).
",['wean patients from invasive mechanical ventilation (IMV'],"['Protocolised Weaning Without Non-Invasive Ventilation', 'protocol-directed weaning from mechanical ventilation or ongoing IMV with daily spontaneous breathing trials', 'non-invasive ventilation (NIV', 'Invasive Ventilation']","['Bivariate regression of costs and quality-adjusted life-years (QALYs) provided estimates of the incremental cost per QALY and incremental net monetary benefit (INMB) overall and for subgroups [presence/absence of chronic obstructive pulmonary disease (COPD) and operative status', 'mean INMB', 'cost effective', 'time to liberation from ventilation']","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",,0.203286,"NIV was cost effective over 5 years, with an estimated incremental cost-effectiveness ratio of £4618 ($US6594 per QALY gained).
","[{'ForeName': 'Iftekhar', 'Initials': 'I', 'LastName': 'Khan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. i.khan.2@warwick.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Maredza', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Dipesh', 'Initials': 'D', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Petrou', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-020-00210-1']
316,32088543,Per- and polyfluoroalkyl substances and blood pressure in pre-diabetic adults-cross-sectional and longitudinal analyses of the diabetes prevention program outcomes study.,"The relationship of plasma concentration of per- and polyfluoroalkyl substances (PFAS) with blood pressure (BP) is uncertain. This study examined cross-sectional and prospective associations of PFAS with BP and hypertension. We quantified plasma PFAS concentrations from 957 participants enrolled in the lifestyle and placebo arms of the Diabetes Prevention Program (DPP), a randomized controlled trial with approximately 15 years of follow-up. We used multivariable linear and logistic regressions to test cross-sectional associations of six PFAS, including perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), N-ethyl-perfluorooctane sulfonamido acetic acid (EtFOSAA), N-methyl-perfluorooctane sulfonamido acetic acid (MeFOSAA), and perfluorononanoic acid (PFNA), with BP and hypertension prevalence, respectively, at baseline. We used generalized linear mixed models to estimate longitudinal associations between baseline PFAS and the rate of BP changes, and Cox-Proportional hazard models to estimate risk of developing hypertension relative to baseline PFAS. Models were adjusted for baseline age, sex, race/ethnicity, treatment arm, educational attainment, income, marital status, smoking habit, alcohol drinking, and diet. We tested for effect modification by the treatment arm and sex, and accounted for multiple comparisons using the False-Discovery Rate (FDR). PFAS concentrations and hypertension prevalence within the study population (65.3% female, 57.7% White, 65.3% aged 40-59 years) were comparable to the general U.S. population. Cross-sectionally, we found small but statistically significant associations of baseline plasma concentrations of PFOA with systolic BP (β per doubling: 1.49 mmHg, 95% CI: 0.29, 2.70); and MeFOSAA with hypertension (RR = 1.09 per doubling, 95% CI: 1.01, 1.19). Estimates were not statistically significant after FDR adjustment. Longitudinally, we observed null associations in the placebo arm, but some inverse associations of baseline PFOS and MeFOSAA with systolic BP in the lifestyle arm, perhaps due to regression toward the mean. Baseline PFAS concentrations also were not prospectively associated with hypertension risk. Overall, there were modest and mostly null associations of plasma PFAS concentrations with BP and hypertension.",2020,Baseline PFAS concentrations also were not prospectively associated with hypertension risk.,"['957 participants enrolled in the lifestyle and placebo arms of the Diabetes Prevention Program (DPP), a randomized controlled trial with approximately 15\xa0years of follow-up', 'within the study population (65.3% female, 57.7% White, 65.3% aged 40-59\xa0years']","['placebo', 'Per- and polyfluoroalkyl substances and blood pressure']","['plasma concentration of per- and polyfluoroalkyl substances (PFAS) with blood pressure (BP', 'perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), N-ethyl-perfluorooctane sulfonamido acetic acid (EtFOSAA), N-methyl-perfluorooctane sulfonamido acetic acid (MeFOSAA), and perfluorononanoic acid (PFNA), with BP and hypertension prevalence', 'plasma PFAS concentrations with BP and hypertension', 'Baseline PFAS concentrations', 'baseline PFOS and MeFOSAA with systolic BP', 'False-Discovery Rate (FDR', 'PFAS concentrations and hypertension prevalence', 'baseline plasma concentrations of PFOA with systolic BP (β per doubling']","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctanesulfonic acid'}, {'cui': 'C0070403', 'cui_str': 'perfluorooctanoic acid'}, {'cui': 'C1176320', 'cui_str': 'perflexane'}, {'cui': 'C0038762', 'cui_str': 'Sulfonic Acids'}, {'cui': 'C0166273', 'cui_str': 'perfluorooctane'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C3712911', 'cui_str': 'Nonanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluoro-'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",957.0,0.0700998,Baseline PFAS concentrations also were not prospectively associated with hypertension risk.,"[{'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: p_lin@harvardpilgrim.org.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA, USA. Electronic address: andres.cardenas@berkeley.edu.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: rhauser@hsph.harvard.edu.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: redrg@channing.harvard.edu.""}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics, School of Public Health and Human Sciences, University of Massachusetts Amherst, Amherst, MA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA; Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: mhivert@partners.org.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: aic7@cdc.gov.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: twebster@bu.edu.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA. Electronic address: edward.horton@joslin.harvard.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: emily_oken@harvardpilgrim.org.'}]",Environment international,['10.1016/j.envint.2020.105573']
317,31698085,Centralized Reminder/Recall to Increase Influenza Vaccination Rates: A Two-State Pragmatic Randomized Trial.,"OBJECTIVE


Centralized reminder/recall (C-R/R) by health departments using immunization information systems is more effective and cost effective than practice-based approaches for increasing childhood vaccines but has not been studied for influenza vaccination. We assessed effectiveness and cost of C-R/R for increasing childhood influenza vaccination compared with usual care.
METHODS


Within Colorado (CO) and New York (NY), random samples of primary care practices (pediatric, family medicine, and health center) were selected proportionate to where children are served-65 practices (N = 54,353 children) in CO; 101 practices (N = 65,777) in NY. We conducted 4-arm RCTs per state (1, 2, or 3 autodial reminders vs usual care), with randomization at the patient level within practices from 10/2016 to 1/2017.
RESULTS


In CO, the maximum absolute difference in receipt of ≥1 influenza vaccine was 1.7% between the 2 R/R group and control (adjusted risk ratio [ARR] of 1.06 [1.01, 1.10]); other R/R arms did not differ significantly. In NY, ARRs for the study arms versus control varied from 1.05 (1.01, 1.10) for 3 R/R to 1.06 (1.01, 1.11) for 1-2 R/R groups and maximum absolute increase in vaccination was 0.6%. In time-to-event analyses, study arm was a significant predictor of vaccination in CO (P = .001) but not in NY. Costs/child randomized to one message were $.17 in CO and $.23 in NY.
CONCLUSIONS


C-R/R for influenza vaccine using autodial had low-level effects on increasing influenza rates in 2 states. Given the feasibility and low cost of C-R/R in previous trials, its utility for influenza should be re-examined using different modalities.",2020,"In time-to-event analyses, study arm was a significant predictor of vaccination in CO (p=.001) but not in NY.","['65 practices (N=54,353 children) in CO; 101 practices (N=65,777) in NY', 'Within Colorado (CO) and New York (NY), random samples of primary care practices (pediatric, family medicine, health center) were selected proportionate to where children are']",['served'],"['Influenza Vaccination Rates', 'receipt of ≥1 influenza vaccine', 'influenza rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]",,0.103594,"In time-to-event analyses, study arm was a significant predictor of vaccination in CO (p=.001) but not in NY.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine (A Kempe), Aurora, Colo. Electronic address: allison.kempe@childrenscolorado.org.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles (C Albertin and P Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California (X Zhou, S Vangela, and C-H Tseng), Los Angeles, Calif.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangela', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California (X Zhou, S Vangela, and C-H Tseng), Los Angeles, Calif.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo; Department of Family Medicine, University of Colorado School of Medicine (LM Dickinson), Aurora, Colo.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California (X Zhou, S Vangela, and C-H Tseng), Los Angeles, Calif.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus (JD Campbell and M Whittington), Aurora, Colo.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus (JD Campbell and M Whittington), Aurora, Colo.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gurfinkel', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment (H Roth), Denver, Colo.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health (D Hoefer), Albany, NY.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles (C Albertin and P Szilagyi), Los Angeles, Calif.""}]",Academic pediatrics,['10.1016/j.acap.2019.10.015']
318,32170769,Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: CALGB/Alliance 50403.,"Immunochemotherapy followed by autologous transplant (ASCT) in CALGB/Alliance 59909 achieved a median progression-free survival (PFS) in mantle cell lymphoma (MCL) of 5 years, but late recurrences occurred. We evaluated tolerability and efficacy of adding post-transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB/Alliance 50403, a randomized phase II trial. Following augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg/m 2  IV days 1, 4, 8, 11 of a 3-week cycle for four cycles) or BM (1.6 mg/m 2  IV once weekly × 4 every 8 weeks for 18 months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4 years (P < .001). The 8-year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%-71.5%) and 64.4% (95% 51.8%-79.0%), respectively. Progression-free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD-negative post-induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long-term follow up suggests a PFS benefit from the addition of BC or BM post- transplant.",2020,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","['151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized']","['Immunochemotherapy and Autologous Stem Cell Transplantation', 'Immunochemotherapy followed by autologous transplant (ASCT', 'adding post-transplant bortezomib consolidation (BC) or maintenance (BM', 'Bortezomib Consolidation or Maintenance', 'augmented-dose R-CHOP/ methotrexate, high-dose cytarabine-based stem cell mobilization, cyclophosphamide/carmustine/etoposide (CBV) autotransplant, and rituximab']","['8-year PFS estimates', 'Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow', 'PFS and OS', 'toxicity', 'median progression-free survival (PFS', 'PFS', 'tolerability and efficacy', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0524864', 'cui_str': 'Stem Cell Mobilization'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0007257', 'cui_str': 'Carmustine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",151.0,0.0888476,"Both arms met the primary endpoint, with median PFS significantly greater than 4 years (p < 0.001).","[{'ForeName': 'Lawrence D', 'Initials': 'LD', 'LastName': 'Kaplan', 'Affiliation': 'Medicine/Hematology-Oncology, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Maurer', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St Louis, Missouri, USA.'}, {'ForeName': 'Noreen', 'Initials': 'N', 'LastName': 'Fulton', 'Affiliation': 'Medicine, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Pettinger', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Hematology, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Ann S', 'Initials': 'AS', 'LastName': 'LaCasce', 'Affiliation': 'Medical Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Hsi', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Yi Tian', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scott', 'Affiliation': 'Centre for Lymphoid Cancer, British Columbia Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hurd', 'Affiliation': 'Hematology-Oncology, Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Ruppert', 'Affiliation': 'Alliance Statistics and Data Center, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hernandez-Ilizaliturri', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Department of Medicine, Weill Medical College of Cornell University, New York, New York, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Hematology-Oncology, MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}]",American journal of hematology,['10.1002/ajh.25783']
319,32182615,Closed vs. Open Oocyte Vitrification Methods Are Equally Effective for Blastocyst Embryo Transfers: Prospective Study from a Sibling Oocyte Donation Program.,"PURPOSE


To assess whether open and closed vitrification protocols are equally effective for sibling-oocyte cycles when performing blastocyst embryo transfers.
MATERIALS AND METHODS


A prospective study was set up comparing the open and the closed vitrification techniques in oocyte recipients sharing sibling oocytes between 2014 and 2016. Sibling oocytes were randomly and equally assigned into the closed group (oocytes vitrified in a closed system) or the open group (oocytes vitrified in an open system). Intracytoplasmic sperm injection was performed on all cases. Embryo transfers were performed on day 5. Power analysis calculation showed that 94 cycles would be needed for each group in the study in order to achieve statistical significance at a 5% level with power 80%.
RESULTS


The final number of donors included was 95. A total of 190 recipients matched with their donors were included in the study. There was no difference in the mean number of oocytes vitrified with the closed or the open system (8.26 ± 2.54 vs. 8.31 ± 2.57). No significant difference was observed between the 2 groups regarding survival rate, fertilization rate, cleavage rate, top-quality embryos on day 3, blastocyst rate, and top-quality blastocyst rate. Moreover, no statistically significant difference in the b-human chorionic gonadotropin-positive rate, clinical pregnancy rate per cycle, implantation rate, ongoing pregnancy rate, and live birth rate between closed and open groups.
CONCLUSION


Οpen and closed vitrification protocols are equally effective for sibling-oocyte cycles.",2020,"No significant difference was observed between the 2 groups regarding survival rate, fertilization rate, cleavage rate, top-quality embryos on day 3, blastocyst rate, and top-quality blastocyst rate.","['Sibling oocytes', '190 recipients matched with their donors were included in the study', 'oocyte recipients sharing sibling oocytes between 2014 and 2016']","['Intracytoplasmic sperm injection', 'closed group (oocytes vitrified in a closed system) or the open group (oocytes vitrified in an open system', 'open and closed vitrification protocols']","['survival rate, fertilization rate, cleavage rate, top-quality embryos on day 3, blastocyst rate, and top-quality blastocyst rate', 'mean number of oocytes vitrified', 'b-human chorionic gonadotropin-positive rate, clinical pregnancy rate per cycle, implantation rate, ongoing pregnancy rate, and live birth rate']","[{'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0455164', 'cui_str': 'ICSI'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C2936610', 'cui_str': 'Glass-Liquid Transition'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005705', 'cui_str': 'Embryo stage 3 structure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes (qualifier value)'}, {'cui': 'C3203517', 'cui_str': 'Human chorionic gonadotropin positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",190.0,0.0153792,"No significant difference was observed between the 2 groups regarding survival rate, fertilization rate, cleavage rate, top-quality embryos on day 3, blastocyst rate, and top-quality blastocyst rate.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gullo', 'Affiliation': 'Department of Human Pathology, University of Messina, Messina, Italy.'}, {'ForeName': 'Stamatios', 'Initials': 'S', 'LastName': 'Petousis', 'Affiliation': 'IAKENTRO, Infertility Treatment Center, Thessaloniki, Greece, petousisstamatios@gmail.com.'}, {'ForeName': 'Achilleas', 'Initials': 'A', 'LastName': 'Papatheodorou', 'Affiliation': 'IAKENTRO, Infertility Treatment Center, Thessaloniki, Greece.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Panagiotidis', 'Affiliation': 'IAKENTRO, Infertility Treatment Center, Thessaloniki, Greece.'}, {'ForeName': 'Chrysoula', 'Initials': 'C', 'LastName': 'Margioula-Siarkou', 'Affiliation': 'IAKENTRO, Infertility Treatment Center, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Prapas', 'Affiliation': 'IAKENTRO, Infertility Treatment Center, Thessaloniki, Greece.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': ""D'Anna"", 'Affiliation': 'Department of Human Pathology, University of Messina, Messina, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Perino', 'Affiliation': 'Department of Sciences for Health Promotion and Mother-Child Care ""G. D\'Alessandro,"" Polyclinic University Hospital, Palermo, Italy.'}, {'ForeName': 'Gaspare', 'Initials': 'G', 'LastName': 'Cucinella', 'Affiliation': 'Department of Sciences for Health Promotion and Mother-Child Care ""G. D\'Alessandro,"" Polyclinic University Hospital, Palermo, Italy.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Prapas', 'Affiliation': 'IAKENTRO, Infertility Treatment Center, Thessaloniki, Greece.'}]",Gynecologic and obstetric investigation,['10.1159/000506803']
320,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
321,32072866,Effects of a Video-based Intervention on Caregiver Confidence for Managing Dementia Care Challenges: Findings from the FamTechCare Clinical Trial.,"OBJECTIVES


The Supporting Family Caregivers with Technology trial tested the FamTechCare video support intervention against telephone support. Dementia caregivers' video-recorded challenging care encounters and an interdisciplinary team provided tailored feedback. This paper reports on the effects of the intervention on caregiver confidence in managing priority challenges, a secondary outcome of this non-blinded parallel randomized controlled trial.
METHODS


Caregiver/person living with dementia dyads were randomized to the experimental FamTechCare video support (n = 43) or attention control telephone support (n = 41) groups. Caregivers providing in-home care to a person living with mild or more severe dementia were eligible. Caregivers identified three priority challenges using the Caregiver Target Problems Questionnaire and rated the frequency and severity of each challenge and their confidence managing the challenge at baseline and 3-months. Challenges were classified using the FamTechCare Technology-supported Dementia Care Typology. Effects on confidence were compared between groups using the Wilcoxon rank-sum test and within groups using the Wilcoxon signed-rank test.
RESULTS


Caregiver priority challenges included managing dementia behaviors, understanding disease expectations, and performing activity of daily living care. Improvements were observed across the three categories in both groups; however, not all changes were statistically significant. No significant differences were identified between groups.
CONCLUSION


Caregivers in the FamTechCare group reported benefit across all priority challenges including managing dementia behaviors, understanding disease expectations, and performing activity of daily living care.
CLINICAL IMPLICATIONS


Innovative technology provides new opportunities to support family caregivers in dementia home care. Video-recording can be used to enhance support for family caregivers facing care challenges.",2020,"Improvements were observed across the three categories in both groups; however, not all changes were statistically significant.","['Caregiver/person living with dementia dyads', 'person living with mild or more severe dementia were eligible']","['FamTechCare video support intervention against telephone support', 'Video-based Intervention', 'FamTechCare', 'experimental FamTechCare video support (n\xa0=\xa043) or attention control telephone support']","['Caregiver Confidence', 'caregiver confidence']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia (disorder)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",,0.0576217,"Improvements were observed across the three categories in both groups; however, not all changes were statistically significant.","[{'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'College of Nursing, University of Iowa , Iowa City, Iowa, USA.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, University of Kansas , Kansas City, Kansas, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'College of Nursing, University of Iowa , Iowa City, Iowa, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'College of Nursing, University of Iowa , Iowa City, Iowa, USA.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'School of Nursing, University of Kansas , Kansas City, Kansas, USA.'}]",Clinical gerontologist,['10.1080/07317115.2020.1729917']
322,32169633,Novelty exposure modulates visual and verbal emotional memory: An experimental design with adults.,"The detection and processing of novelty play a critical role in memory formation. The effect of novelty intervention in memory has been demonstrated with rodents in several lines of research; however, it has not been explored as extensively in humans. In this research, we evaluated the effect of novelty exposure on two types of emotional memory: visual (Study 1) and verbal (Study 2). Eighty healthy volunteers participated in both studies. First, all participants watched a video (session 1); seven days later (session 2), participants in the control group watched the same video and those in the experimental condition were exposed to a novel one. Immediately after exposure, all participants looked at 36 pictures (or listened to 36 words). Soon afterward, a two-task test was administered to evaluate memory (immediate free recall and recognition). A week later (session 3), the two-task test was run again (deferred free recall and recognition). Regarding emotional memory processing, the emotional information was more activating and better remembered than the neutral one, for both visual and verbal information. Regarding the novelty effect, the participants exposed to the novel video had better recall than the control on the deferred measures. Thus, our results provide evidence of the effect of novelty exposure on two different types of emotional memory, with great potentialities in clinical and educational settings.",2020,"Regarding the novelty effect, the participants exposed to the novel video had better recall than the control on the deferred measures.",['Eighty healthy volunteers participated in both studies'],['novelty intervention'],['Novelty exposure modulates visual and verbal emotional memory'],"[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",80.0,0.0372488,"Regarding the novelty effect, the participants exposed to the novel video had better recall than the control on the deferred measures.","[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Diaz Abrahan', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC(3)), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), Argentina; Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Argentina; Universidad Nacional de Córdoba (UNC), Argentina.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Psyrdellis', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC(3)), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), Argentina; Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Argentina; Universidad Nacional de Córdoba (UNC), Argentina.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Justel', 'Affiliation': 'Lab. Interdisciplinario de Neurociencia Cognitiva (LINC), Centro de Estudios Multidisciplinarios en Sistemas Complejos y Ciencias del Cerebro (CEMSC(3)), Instituto de Ciencias Físicas (ICIFI), Escuela de Ciencia y Tecnología (ECyT), Universidad de San Martín (UNSAM), Argentina; Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Argentina; Universidad Nacional de Córdoba (UNC), Argentina. Electronic address: nadiajustel@conicet.gov.ar.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103029']
323,30252783,Sex- and Gender-Related Factors Associated With Cardiac Rehabilitation Enrollment: A SECONDARY ANALYSIS AMONG SYSTEMATICALLY REFERRED PATIENTS.,"PURPOSE


To assess sex- and gender-related factors associated with cardiac rehabilitation (CR) enrollment following acute coronary syndrome among systematically referred patients.
METHODS


This secondary analysis of a randomized controlled trial used an exploratory approach to examine the TRANSITion process for patients between the coronary care unit and CR (TRANSIT-UC). The present analysis examined the relationship between sex- and gender-related factors and CR enrollment in systematically referred women (n = 35) and men (n = 207). We performed χ and logistic regression analyses to identify statistically significant results. Using the Bonferroni method, a P value of .002 or less was considered a significant statistical result. A raw difference of 15% or more between enrolled and nonenrolled participants was considered a difference worthy of further investigation.
RESULTS


Men who were regularly engaged in physical activity prior to their hospitalization and who lived near the CR center showed a statistically higher CR enrollment rate. In women and men, a radial entry site for percutaneous coronary intervention resulted in a clinically significant difference in favor of CR enrollment. In women, 3 sex-related and 9 gender-related variables were associated with a difference of 15% or more between enrolled and nonenrolled participants.
CONCLUSION


Factors related to CR enrollment in women and men are suggested. As women keep showing a lower rate of CR enrolment, the investigation of these factors in a larger sample of patients may hold valuable insights to improve CR enrolment.",2019,"In women and men, a radial entry site for percutaneous coronary intervention resulted in a clinically significant difference in favor of CR enrollment.","['systematically referred women (n = 35) and men (n = 207', 'Men who were regularly engaged in physical activity prior to their hospitalization and who lived near the CR center', 'acute coronary syndrome among systematically referred patients', 'patients between the coronary care unit and CR (TRANSIT-UC', 'Cardiac Rehabilitation Enrollment']",['cardiac rehabilitation (CR) enrollment'],"['CR enrollment rate', 'CR enrollment']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010066', 'cui_str': 'Coronary Care Units'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]",[],207.0,0.114663,"In women and men, a radial entry site for percutaneous coronary intervention resulted in a clinically significant difference in favor of CR enrollment.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Cossette', 'Affiliation': ""Faculty of Nursing (Drs Cossette and Mailhot and Messrs Maheu-Cadotte and Fontaine) and Faculty of Medicine (Drs Dupuis, Juneau, and Cournoyer), Université de Montréal, Montreal, Quebec, Canada; Montreal Heart Institute Research Center, Quebec, Canada (Drs Cossette, Mailhot, Dupuis, and Juneau, Messrs Maheu-Cadotte and Fontaine, and Ms Cournoyer); Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada (Mr Maheu-Cadotte); Hôpital du Sacré-Cœur de Montréal, Montreal, Quebec, Canada (Dr Cournoyer); and Montreal Health Innovation Coordinating Center, Quebec, Canada (Dr Guertin).""}, {'ForeName': 'Marc-André', 'Initials': 'MA', 'LastName': 'Maheu-Cadotte', 'Affiliation': ''}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Mailhot', 'Affiliation': ''}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Fontaine', 'Affiliation': ''}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Cournoyer', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cournoyer', 'Affiliation': ''}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juneau', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000364']
324,30958348,Extracellular Vesicle Biomarkers Track Cognitive Changes Following Intranasal Insulin in Alzheimer's Disease.,"BACKGROUND


Insulin resistance is implicated in Alzheimer's disease (AD), whereas intranasal insulin is an experimental treatment in clinical trials. We previously proposed insulin signaling mediators in plasma neuronal-enriched extracellular vesicles (EVs) as biomarkers of brain insulin resistance.
OBJECTIVE


We sought to demonstrate the capacity of neuronal-enriched EV biomarkers to demonstrate target engagement in response to intranasal insulin and their ability to track treatment-associated cognitive changes in AD.
METHODS


We isolated neuronal-enriched EVs from plasma samples of participants with amnestic mild cognitive impairment or probable AD involved in a 4-month duration placebo-controlled clinical trial of 20 or 40 IU intranasal insulin. We measured insulin signaling mediators as biomarkers and examined treatment-associated changes and their relationship with cognitive performance (ADAS-Cog).
RESULTS


There were no EV biomarker changes from baseline in any of the treatment groups. In participants treated with 20 IU insulin, EV biomarkers of insulin resistance (pS312-IRS-1, pY-IRS-1) showed strong positive correlations with ADAS-Cog changes, especially in ApoE ɛ4 non-carriers.
CONCLUSION


Neuronal EV biomarkers of insulin resistance (pS312-IRS-1, pY-IRS-1) were associated with cognitive changes in response to low dose intranasal insulin suggesting engagement of the insulin cascade in neurons of origin.",2019,"In participants treated with 20 IU insulin, EV biomarkers of insulin resistance (pS312-IRS-1, pY-IRS-1) showed strong positive correlations with ADAS-Cog changes, especially in ApoE ɛ4 non-carriers.
CONCLUSION


Neuronal EV biomarkers of insulin resistance (pS312-IRS-1, pY-IRS-1) were associated with cognitive changes in response to low dose intranasal insulin suggesting engagement of the insulin cascade in neurons of origin.","['participants with amnestic mild cognitive impairment or probable AD involved in a 4-month duration placebo-controlled clinical trial of 20 or 40 IU', ""Alzheimer's Disease""]","['intranasal insulin', 'Intranasal Insulin']",[],"[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",[],,0.172076,"In participants treated with 20 IU insulin, EV biomarkers of insulin resistance (pS312-IRS-1, pY-IRS-1) showed strong positive correlations with ADAS-Cog changes, especially in ApoE ɛ4 non-carriers.
CONCLUSION


Neuronal EV biomarkers of insulin resistance (pS312-IRS-1, pY-IRS-1) were associated with cognitive changes in response to low dose intranasal insulin suggesting engagement of the insulin cascade in neurons of origin.","[{'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Mustapic', 'Affiliation': 'Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, NIH, Baltimore, MD, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, NIH, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, NIH, Baltimore, MD, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180578']
325,30958353,D-Cycloserine Improves Difficult Discriminations in a Pattern Separation Task in Alzheimer's Disease Patients with Dementia.,"Recent fMRI studies in human identified that pattern separation ability is associated with increased activity in the hippocampal dentate gyrus (DG), whereas no such DG changes are seen during pattern completion. Disruption to neurogenesis in the DG has been associated with Alzheimer's disease (AD). In a post-hoc analysis of two large unsuccessful AD clinical trials, we examined the effect of D-cycloserine (DCS) on a specific object pattern separation measure, a component of the picture recognition task from the Cognitive Drug Research (CDR) system. This task yields a measure of pattern separation and a measure of pattern completion. Study data were available for 756 AD patients with dementia, randomized to several doses of DCS. Data were available at week 2, 6, 14, and 26 for 732, 707, 653, and 559 patients, respectively. None of the DCS doses had a statistically significant benefit over placebo on pattern completion. However, the DCS 15 mg BID dose significantly increased accuracy over placebo on the pattern separation measure by 5.1%. Further, the magnitude of the benefit of DCS 15 mg BID over placebo was almost doubled relative to the whole study population in a subset of patients whose pattern separation scores were≥2 standard deviations poorer than the CDR norm of age-matched healthy individuals at baseline. These post-hoc analyses suggest a potential value of the pattern separation task for evaluating compounds promoting neurogenesis. Further, the use of a restrictive pattern separation eligibility criterion might facilitate signal detection.",2019,"However, the DCS 15 mg BID dose significantly increased accuracy over placebo on the pattern separation measure by 5.1%.","[""Alzheimer's Disease Patients with Dementia"", '756 AD patients with dementia']","['D-cycloserine (DCS', 'placebo', 'D-Cycloserine', 'DCS']",['accuracy'],"[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],756.0,0.0570808,"However, the DCS 15 mg BID dose significantly increased accuracy over placebo on the pattern separation measure by 5.1%.","[{'ForeName': 'Pascal J D', 'Initials': 'PJD', 'LastName': 'Goetghebeur', 'Affiliation': 'Bracket LLC, Reading, UK.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Wesnes', 'Affiliation': 'Wesnes Cognition Ltd, Streatley on Thames, UK.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Targum', 'Affiliation': 'Bracket LLC, Boston, MA, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181094']
326,31262573,Effect of Tramadol Pretreatment on Sufentanil-Induced Cough.,"PURPOSE


To investigate the effect of tramadol pretreatment on the incidence and severity of sufentanil-induced cough.
DESIGN


Randomized controlled trial.
METHODS


Adults of both genders (N = 304; 18 to 65 years old, American Society of Anesthesiologists physical status I to II), scheduled for elective surgery, were randomized into two groups (n = 152): intravenous administration of tramadol 1 mg/kg (group T) or normal saline (group C). Then sufentanil bolus 0.3 mcg/kg was administered intravenously in 5 seconds. The incidence and severity of cough were observed for 1 minute. Mean arterial pressure, heart rate, nausea, vomiting, and truncal rigidity during induction were also recorded.
FINDINGS


Patient characteristics were similar between the two groups. The incidence of cough was significantly lower in group T when compared with group C (7.9% vs 18.4%, P < .05); there were nine patients coughing severely in group C, whereas no severe cough occurred in group T (P < .05). The mean arterial pressure, heart rate, and incidences of other side effects were comparable between the two groups.
CONCLUSIONS


Pretreatment of intravenous tramadol 1 mg/kg could be a clinically effective intervention for attenuating sufentanil-induced cough.",2019,"The mean arterial pressure, heart rate, and incidences of other side effects were comparable between the two groups.
","['Adults of both genders (N\xa0=\xa0304; 18 to 65\xa0years old, American Society of Anesthesiologists physical status I to II), scheduled for elective surgery']","['Tramadol', 'tramadol 1\xa0mg/kg (group T) or normal saline', 'sufentanil', 'tramadol']","['Mean arterial pressure, heart rate, nausea, vomiting, and truncal rigidity during induction', 'incidence of cough', 'mean arterial pressure, heart rate, and incidences of other side effects', 'incidence and severity of cough', 'Sufentanil-Induced Cough', 'severe cough']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",304.0,0.159057,"The mean arterial pressure, heart rate, and incidences of other side effects were comparable between the two groups.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Yingzi', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ''}, {'ForeName': 'Gaoyin', 'Initials': 'G', 'LastName': 'Kong', 'Affiliation': ''}, {'ForeName': 'Yixun', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.01.013']
327,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
328,31927774,"Men's Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of a prospective, randomised, placebo-controlled study.","AIM


To assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia.
METHODS


This was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed-dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo. End-points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs.
RESULTS


The intent-to-treat population comprised 489 patients (DUT-TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT-TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT-TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT-TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6-10 points in the total MSHQ score were more likely to report SexAEs.
CONCLUSION


Findings support the clinical utility of the MSHQ tool in assessing the impact of DUT-TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.",2020,"The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs.","['benign prostatic hyperplasia', 'patients with benign prostatic hyperplasia', '489 patients (DUT-TAM FDC, n=243; placebo, n=246', 'patients aged ≥50 years']","['placebo', 'dutasteride/tamsulosin combination therapy', 'dutasteride 0.5\xa0mg and tamsulosin 0.4 mg (DUT-TAM FDC), or placebo']","['worsening of MSHQ ejaculation and erection domain scores', 'total MSHQ score', 'change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to Month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs', 'MSHQ scores', ""Men's Sexual Health Questionnaire (MSHQ) total scores"", ""Men's Sexual Health Questionnaire score changes"", 'MSHQ total score']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2926870', 'cui_str': 'Dutasteride / tamsulosin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1593561', 'cui_str': 'Dutasteride 0.5 MG [Avodart]'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0424400', 'cui_str': 'Erotic interest (observable entity)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",489.0,0.311912,"The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs.","[{'ForeName': 'Claus G', 'Initials': 'CG', 'LastName': 'Roehrborn', 'Affiliation': 'Department of Urology, UT Southwestern Medical Centre, University of Texas, Dallas, TX, USA.'}, {'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Rosen', 'Affiliation': 'HealthCore/New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Manyak', 'Affiliation': 'GSK, Washington, DC, USA.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Palacios-Moreno', 'Affiliation': 'GSK, Madrid, Spain.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Wilson', 'Affiliation': 'PAREXEL International, Durham, NC, USA.'}, {'ForeName': 'Zrinka', 'Initials': 'Z', 'LastName': 'Lulic', 'Affiliation': 'GSK, Brentford, UK.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Giuliano', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France.'}]",International journal of clinical practice,['10.1111/ijcp.13480']
329,31741204,Quality of life outcomes of web-based and in-person weight management for adults with serious mental illness.,"Adults with serious mental illness have high rates of obesity, with associated negative impacts on health-related quality of life. The present study utilized data from a randomized controlled trial (N = 276) to examine the effectiveness of in-person and online-delivered weight management interventions, compared to usual care, for improving health-related quality of life in this population. Participants completed quality of life assessments at baseline, 3 months, and 6 months. Mixed effects models examined group by time interactions. Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018). Web-based and in-person weight management led to improvements in health-related quality of life for adults with serious mental illness.ClinicalTrials.gov Identifier: NCT00983476.",2020,"Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018).","['adults with serious mental illness', 'Adults with serious mental illness']","['person and online-delivered weight management interventions', 'web-based and in-person weight management']","['mental health related quality of life', 'quality of life assessments', 'health-related quality of life', 'mental health-related quality of life', 'weight-related self-esteem', 'loneliness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0023974', 'cui_str': 'Loneliness'}]",276.0,0.177496,"Compared to usual care, in-person MOVE was associated with improvements in loneliness (t = - 2.76, p = .006) and mental health related quality of life (t = 1.99, p = 0.048) at 6 months, and webMOVE was associated with improvements in weight-related self-esteem at 6 months (t = 2.23, p = .026) and mental health-related quality of life at 3 months (t = 2.17, p = 0.031) and 6 months (t = 2.38, p = .018).","[{'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Muralidharan', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA. anjana.muralidharan2@va.gov.'}, {'ForeName': 'Clayton H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Division of Psychiatric Services Research, Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Noosha', 'Initials': 'N', 'LastName': 'Niv', 'Affiliation': 'Veterans Affairs Desert Pacific Mental Illness Research, Education, and Clinical Center (MIRECC), Long Beach, CA, USA.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kreyenbuhl', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Oberman', 'Affiliation': 'VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Goldberg', 'Affiliation': 'Veterans Affairs (VA) Capitol Health Care Network (VISN 5), Mental Illness, Research, Education, and Clinical Center (MIRECC), Baltimore, MD, USA.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00117-1']
330,32242806,Spinal mobility in the cervical and lumbar spine correlates with magnetic resonance imaging findings for inflammatory and structural changes in patients with active ankylosing spondylitis.,"OBJECTIVES


We aimed to assess relationships between single Bath Ankylosing Spondylitis Metrology Index (BASMI) components and corresponding spinal segment magnetic resonance images (MRI) in anti-tumour-necrosis-factor-treated AS patients.
METHODS


Using available MRI and BASMI data from the GO-RAISE trial (n=91 patients), MRI scores for active inflammatory (ASspiMRI-a) and chronic structural (ASspiMRI-c) changes in cervical and lumbar spine segments were compared with BASMI cervical (cervical-rotation [CR] angle, tragus-to-wall [TTW] distance) and lumbar (lumbar flexion [LF], lateral-lumbar-flexion [LLF]) spine component scores (linear definition). Generalised linear models were employed to assess relationships between BASMI components and ASspiMRI-a/ASspiMRI-c measurements at baseline and for week-14 (golimumab/placebo groups) and week-104 (all golimumab-treated) change scores.
RESULTS


Baseline lumbar ASspiMRI-a scores correlated with LF and LLF (β=0.231 and 0.238, respectively; both p<0.01), while this was less prominent for ASspiMRI-c scores and LLF (β=0.142, p=0.04). A significant but weak correlation was found between changes from baseline to week 104 in cervical spine ASspiMRI-c score and TTW distance among all treated patients (β=0.161, p=0.003).
CONCLUSIONS


Detailed assessments indicated baseline spinal mobility impairment in patients with active AS correlated weakly with MRI-detected lumbar spinal inflammation; correlations with chronic, structural damage/changes were very weak. Improved, less variable MRI and spinal metrology assessments are needed for future clinical research.",2020,"A significant but weak correlation was found between changes from baseline to week 104 in cervical spine ASspiMRI-c score and TTW distance among all treated patients (β=0.161, p=0.003).
",['patients with active ankylosing spondylitis'],"['single Bath Ankylosing Spondylitis Metrology Index (BASMI) components and corresponding spinal segment magnetic resonance images (MRI', 'magnetic resonance imaging']","['baseline spinal mobility impairment', 'cervical spine ASspiMRI-c score and TTW distance', 'MRI scores for active inflammatory (ASspiMRI-a) and chronic structural (ASspiMRI-c) changes in cervical and lumbar spine segments']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",91.0,0.0600284,"A significant but weak correlation was found between changes from baseline to week 104 in cervical spine ASspiMRI-c score and TTW distance among all treated patients (β=0.161, p=0.003).
","[{'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany. xenofon.baraliakos@elisabethgruppe.de.'}, {'ForeName': 'Kay-Geert A', 'Initials': 'KA', 'LastName': 'Hermann', 'Affiliation': 'Radiology, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany.'}]",Clinical and experimental rheumatology,[]
331,31241519,Home-Based Pulmonary Rehabilitation for Patients With Idiopathic Pulmonary Fibrosis: A PILOT STUDY.,"PURPOSE


To evaluate the adherence and effectiveness of a home-based exergame program for patients with idiopathic pulmonary fibrosis (IPF).
METHOD


Patients with IPF were randomly assigned to a relatively unsupervised Wii Fit exergame intervention group or Wii video game control group (with no active whole-body movement involved). Participants in both groups were instructed to play their respective games 30 min/d, 3 d/wk for 12 wk. In addition, they were asked to perform their usual exercise/physical activities. Outcome measures were 6-min walk distance (6MWD), exercise-related dyspnea, and St George's Respiratory Questionnaire (SGRQ).
RESULTS


The 20 participants differed significantly between intervention and control groups in baseline characteristics (forced vital capacity = 2.0 ± 0.5 vs 3.1 ± 0.7 L; forced expiratory volume in 1 sec = 1.7 ± 0.4 vs 2.5 ± 0.6 L, respectively). Participant adherence rate to the exergame program was very low (20%). There was no significant improvement in the outcome measures in either group. In fact, both the intervention and control groups had a deterioration in 6MWD (-22 ± 56 m vs -60 ± 111 m), respectively and SGRQ scores (3 ± 9 vs 1 ± 11), respectively.
CONCLUSIONS


The home-based exergame intervention for patients with IPF did not show improvement in functional performance, dyspnea, or health-related quality of life at the completion of the 12-wk program in our 2 heterogeneous groups. In addition to the low adherence rate, insufficient frequencies and durations of exergaming may contribute to the lack of improvement. A lack of effectiveness of home-based pulmonary rehabilitation using exergaming for patients with IPF appears consistent with prior observational studies that used more traditional modes of home-based exercise.",2019,"The home-based exergame intervention for patients with IPF did not show improvement in functional performance, dyspnea, or health-related quality of life at the completion of the 12-wk program in our 2 heterogeneous groups.","['Patients with IPF', 'patients with idiopathic pulmonary fibrosis (IPF', 'patients with IPF', 'Patients With Idiopathic Pulmonary Fibrosis']","['Home-Based Pulmonary Rehabilitation', 'relatively unsupervised Wii Fit exergame intervention group or Wii video game control group (with no active whole-body movement involved', 'home-based exergame program', 'home-based pulmonary rehabilitation']","['functional performance, dyspnea, or health-related quality of life', ""6-min walk distance (6MWD), exercise-related dyspnea, and St George's Respiratory Questionnaire (SGRQ"", 'Participant adherence rate', 'adherence and effectiveness', 'deterioration in 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C3853978'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0432634,"The home-based exergame intervention for patients with IPF did not show improvement in functional performance, dyspnea, or health-related quality of life at the completion of the 12-wk program in our 2 heterogeneous groups.","[{'ForeName': 'Hon K', 'Initials': 'HK', 'LastName': 'Yuen', 'Affiliation': 'Department of Occupational Therapy, School of Health Professions (Dr Yuen), Department of Physical Therapy, School of Health Professions (Dr Lowman), Division of Preventive Medicine, Department of Medicine (Dr Oster), and Interstitial Lung Disease Program, Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine (Dr de Andrade), University of Alabama at Birmingham.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Lowman', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Oster', 'Affiliation': ''}, {'ForeName': 'Joao A', 'Initials': 'JA', 'LastName': 'de Andrade', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000418']
332,30958356,Homocysteine Status Modifies the Treatment Effect of Omega-3 Fatty Acids on Cognition in a Randomized Clinical Trial in Mild to Moderate Alzheimer's Disease: The OmegAD Study.,"BACKGROUND


Trials of supplementation with omega-3 fatty acids (ω3-FAs) in patients with mild cognitive impairment or Alzheimer's disease (AD) have produced inconsistent effects on cognitive decline. There is evidence of an interaction between B vitamin status and ω3-FAs in relation to brain atrophy and cognitive decline.
OBJECTIVE


We investigated whether baseline levels of plasma total homocysteine (tHcy), a marker of B vitamin status, modify the effects of ω3-FAs supplementation on cognitive performance in moderate AD.
METHODS


This post hoc analysis of the OmegAD trial included 171 community-based patients with AD (MMSE≥15): 88 patients received daily doses of 1.7 g docosahexaenoic acid and 0.6 g eicosapentaenoic acid for 6 months. Treatment outcome on cognition was analyzed according to baseline levels of tHcy using a general linear model and ANCOVA.
RESULTS


We found significant interactions between ω3-FA supplementation and tHcy on cognition and clinical stage assessed by MMSE (p = 0.040), global CDR (p = 0.059), and CDRsob (p = 0.023), but not on ADAS-cog (p = 0.649). In patients with tHcy levels <11.7μmol/L, ω3-FA supplementation improved cognitive performance as measured by MMSE (+7.1%, 95% CI: 0.59 to 13.7%, p = 0.033) and clinical status as measured by CDRsob (-22.3%, 95% CI: -5.8 to -38.7%, p = 0.009) compared with placebo.
CONCLUSION


The effect of ω3-FA supplementation on MMSE and CDR appears to be influenced by baseline tHcy, suggesting that adequate B vitamin status is required to obtain beneficial effects of ω3-FA on cognition.",2019,"In patients with tHcy levels <11.7μmol/L, ω3-FA supplementation improved cognitive performance as measured by MMSE (+7.1%, 95% CI: 0.59 to 13.7%, p = 0.033) and clinical status as measured by CDRsob (-22.3%, 95% CI: -5.8 to -38.7%, p = 0.009) compared with placebo.
","[""patients with mild cognitive impairment or Alzheimer's disease (AD"", ""Mild to Moderate Alzheimer's Disease"", '171 community-based patients with AD (MMSE≥15): 88 patients received daily doses of 1.7\u200ag', 'moderate AD']","['omega-3 fatty acids (ω3-FAs', 'ω3-FA supplementation', 'docosahexaenoic acid and 0.6\u200ag eicosapentaenoic acid', 'Omega-3 Fatty Acids', 'ω3-FAs supplementation']","['cognition and clinical stage assessed by MMSE', 'global CDR', 'plasma total homocysteine (tHcy', 'cognitive performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}]",171.0,0.335559,"In patients with tHcy levels <11.7μmol/L, ω3-FA supplementation improved cognitive performance as measured by MMSE (+7.1%, 95% CI: 0.59 to 13.7%, p = 0.033) and clinical status as measured by CDRsob (-22.3%, 95% CI: -5.8 to -38.7%, p = 0.009) compared with placebo.
","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Jernerén', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, University of Oslo, Oslo, Norway.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Smith', 'Affiliation': 'Department of Pharmacology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Department of Pharmacology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Palmblad', 'Affiliation': 'Departments of Medicine and Hematology, Karolinska University Hospital Huddinge, and the Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Eriksdotter', 'Affiliation': 'Theme Ageing, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hjorth', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Faxen-Irving', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Lars-Olof', 'Initials': 'LO', 'LastName': 'Wahlund', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schultzberg', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Basun', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Freund-Levi', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, Sweden.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-181148']
333,31324446,Effect of Benson Relaxation on the Intensity of Spinal Anesthesia-Induced Pain After Elective General and Urologic Surgery.,"PURPOSE


The present study aimed to evaluate the effect of Benson's muscle relaxation on postoperative spinal anesthesia-induced pain.
DESIGN


Randomized clinical trial.
METHODS


Sixty-four patients were randomly assigned to intervention and control groups. Benson's muscle relaxation was performed on the intervention group for 10 to 20 minutes based on the patients' tolerance. Before and after the intervention, the two groups were assessed using the visual analog scale and compared. SPSS version 23 was used to analyze data.
FINDINGS


The mean pain score in the control group before and after the intervention was 5.34 and 5.62, respectively (P < .003), and in the intervention group, 5.28 and 4.03, respectively (P < .001).
CONCLUSION


Benson's relaxation technique effectively influenced the intensity of postoperative spinal anesthesia-induced pain. Therefore, it can be used by nurses as a safe, simple, and inexpensive nonmedicinal treatment method to relieve spinal anesthesia-induced pain.",2019,"The mean pain score in the control group before and after the intervention was 5.34 and 5.62, respectively (P < .003), and in the intervention group, 5.28 and 4.03, respectively (P < .001).
",['Sixty-four patients'],"[""Benson's muscle relaxation"", 'Benson Relaxation']","['intensity of postoperative spinal anesthesia-induced pain', 'visual analog scale', 'Intensity of Spinal Anesthesia-Induced Pain', 'mean pain score']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0700323', 'cui_str': 'Neuromuscular block, function (observable entity)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",64.0,0.0250404,"The mean pain score in the control group before and after the intervention was 5.34 and 5.62, respectively (P < .003), and in the intervention group, 5.28 and 4.03, respectively (P < .001).
","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Keihani', 'Affiliation': ''}, {'ForeName': 'Rostam', 'Initials': 'R', 'LastName': 'Jalali', 'Affiliation': ''}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Shamsi', 'Affiliation': ''}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Salari', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.05.005']
334,31492603,Effects of Intraoperative Gelatin on Blood Viscosity and Oxygenation Balance.,"PURPOSE


We aim to investigate whether hemortheology and oxygenation balance are affected by intraoperative gelatin infusion, whether it poses a threat to the perioperative well-being of the patients, and thus creates difficult conditions for postanesthesia care.
DESIGN


A randomized controlled clinical trial.
METHODS


After anesthesia induction, 10 ml/kg succinylated gelatin was infused. Arterial blood gas analysis was performed, and whole blood viscosity and vital signs were recoded both before and after the infusion.
FINDINGS


High shear and medium shear viscosities decreased (P = .003 and P = .04, respectively) after the infusion of both gelatin and Ringer's lactate. The peripheral vascular resistance was not significantly changed by the infusion of either fluid (P = .31). Ringer's lactate reduces the body's oxygen delivery index (P = .01).
CONCLUSIONS


Gelatin better maintains blood viscosity and stabilizes the body's oxygenation balance.",2019,"FINDINGS


High shear and medium shear viscosities decreased (P = .003 and P = .04, respectively) after the infusion of both gelatin and Ringer's lactate.",[],"['Intraoperative Gelatin', 'anesthesia induction, 10\xa0ml/kg succinylated gelatin']","['peripheral vascular resistance', 'blood viscosity and vital signs', 'Blood Viscosity and Oxygenation Balance', ""body's oxygen delivery index"", 'High shear and medium shear viscosities', ""blood viscosity and stabilizes the body's oxygenation balance""]",[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0143961', 'cui_str': 'succinylated gelatin'}]","[{'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0005848', 'cui_str': 'Blood Viscosity'}, {'cui': 'C0518766'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}]",,0.128005,"FINDINGS


High shear and medium shear viscosities decreased (P = .003 and P = .04, respectively) after the infusion of both gelatin and Ringer's lactate.","[{'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Dihan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.05.136']
335,31495558,Using a Virtual Reality Headset to Decrease Pain Felt During a Venipuncture Procedure in Children.,"PURPOSE


This experimental study was conducted to determine the effect of using a virtual reality headset on decreasing the pain felt during a venipuncture procedure in children.
DESIGN


This was a randomized controlled study.
METHODS


The population included 120 children (experimental group = 60, control group = 60) aged 9-12 years who underwent blood collection at a children's hospital clinic. This study collected data using the information form regarding introductory characteristics of children and the venipuncture procedure, the Visual Analogue Scale, and the Wong-Baker Faces Pain Scale.
FINDINGS


This study found that the levels of pain that experimental group children felt during the venipuncture procedure were lower than the levels of pain indicated by control group children (P < .05).
CONCLUSIONS


It was determined that using a virtual reality headset has an effect on decreasing the pain felt during the venipuncture procedure.",2019,It was determined that using a virtual reality headset has an effect on decreasing the pain felt during the venipuncture procedure.,"['children', ""120 children (experimental group\xa0=\xa060, control group\xa0=\xa060) aged 9-12 years who underwent blood collection at a children's hospital clinic"", 'Children']","['virtual reality headset', 'Virtual Reality Headset']","['levels of pain', 'Pain Felt', 'pain felt', 'Visual Analogue Scale, and the Wong-Baker Faces Pain Scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0238749', 'cui_str': 'Baker, general (occupation)'}, {'cui': 'C0015468', 'cui_str': 'Face Pain'}, {'cui': 'C0222045'}]",120.0,0.0598671,It was determined that using a virtual reality headset has an effect on decreasing the pain felt during the venipuncture procedure.,"[{'ForeName': 'Ayla İrem', 'Initials': 'Aİ', 'LastName': 'Aydın', 'Affiliation': ''}, {'ForeName': 'Nurcan', 'Initials': 'N', 'LastName': 'Özyazıcıoğlu', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.05.134']
336,32231968,The Effects of a Self-Instruction Package and Group Training on Trial-Based Functional Analysis Administration.,"This study examined the effects of a self-instruction package comprised of a task analysis data sheet, detailed written instructions, and a small group performance feedback training on the training of 12 undergraduate students to conduct trial-based functional analyses (TBFAs). In contrast to previous research, training omitted technical language and did not include didactic instruction on the principles of applied behavior analysis or the underlying rationale for functional analysis methodology. Although the self-instruction package produced significant increases in performance and reliable data collection on the targeted problem behavior, small group performance feedback training was necessary to achieve mastery across all trial types. Results offer a socially valid training package to teach paraprofessionals to assist Board Certified Behavior Analysts® in conducting TBFAs in applied settings.",2020,"Although the self-instruction package produced significant increases in performance and reliable data collection on the targeted problem behavior, small group performance feedback training was necessary to achieve mastery across all trial types.",['12 undergraduate students to conduct trial-based functional analyses (TBFAs'],"['self-instruction package', 'Self-Instruction Package and Group Training', 'small group performance feedback training']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0558024', 'cui_str': 'Functional analysis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],12.0,0.0123363,"Although the self-instruction package produced significant increases in performance and reliable data collection on the targeted problem behavior, small group performance feedback training was necessary to achieve mastery across all trial types.","[{'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Griffith', 'Affiliation': '1California State University, Sacramento, CA USA.'}, {'ForeName': 'Jenifer N', 'Initials': 'JN', 'LastName': 'Price', 'Affiliation': '1California State University, Sacramento, CA USA.'}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Penrod', 'Affiliation': '1California State University, Sacramento, CA USA.'}]",Behavior analysis in practice,['10.1007/s40617-019-00388-9']
337,32243865,"Efficacy and safety of landiolol, an ultra-short-acting β1-selective antagonist, for treatment of sepsis-related tachyarrhythmia (J-Land 3S): a multicentre, open-label, randomised controlled trial.","BACKGROUND


Tachycardia and atrial fibrillation frequently occur in patients being treated for sepsis or septic shock and have a poor prognosis. Treatments for tachyarrhythmias are often ineffective or contraindicated in this setting. We aimed to investigate the efficacy and safety of landiolol, an ultra-short-acting β-blocker, for treating sepsis-related tachyarrhythmias.
METHODS


We did a multicentre, open-label, randomised controlled trial at 54 hospitals in Japan. Patients admitted to the intensive care units who received conventional treatment for sepsis, according to clinical guidelines for the management of sepsis, and who subsequently developed a tachyarrhythmia, were enrolled. The main inclusion criteria were 20 years of age or older, diagnosis of sepsis according to Third International Consensus Definitions for Sepsis and Septic Shock criteria, administration of catecholamine necessary to maintain mean arterial pressure at 65 mm Hg or more for at least 1 h, and heart rate of 100 beats per min (bpm) or more maintained for at least 10 min without a change in catecholamine dose with diagnosis of atrial fibrillation, atrial flutter, or sinus tachycardia. Only patients who developed these symptoms and signs within 24 h before randomisation, and within 72 h after entering an intensive care unit, were prospectively assigned to receive conventional sepsis therapy alone (control group) or conventional sepsis therapy plus landiolol (landiolol group) in an open-label manner. Landiolol hydrochloride was intravenously infused at an initial dose of 1 μg/kg per min within 2 h after randomisation and the dose could be increased per study protocol to a maximum of 20 μg/kg per min. Patients in both groups received conventional therapy (Japanese Clinical Practice Guidelines for the Management of Sepsis and Septic Shock 2016), including respiratory and fluid resuscitation, antimicrobials, and catecholamines. The treating physicians were required to stabilise the patient's haemodynamic status before randomisation. Randomisation was done using a central randomisation system and dynamic allocation with the minimisation method by institution, heart rate at randomisation (≥100 to <120 bpm or ≥120 bpm), and age (<70 years or ≥70 years). The primary outcome was the proportion of patients with heart rate of 60-94 bpm at 24 h after randomisation. Patients without heart rate data at 24 h after randomisation were handled as non-responders. The primary outcome was analysed using the full analysis set on an as-assigned basis, while safety was analysed using the safety analysis set according to the treatment received. This study was registered with the Japan Pharmaceutical Information Center Clinical Trials Information database, number JapicCTI-173767.
FINDINGS


Between Jan 16, 2018 and Apr 22, 2019, 151 patients were randomly assigned, 76 to the landiolol group and 75 to the control group. A significantly larger proportion of patients in the landiolol group had a heart rate of 60-94 bpm 24 h after randomisation than in the control group (55% [41 of 75] vs 33% [25 of 75]), with a between-group difference of 23·1% (95% CI 7·1-37·5; p=0·0031). Adverse events were observed in 49 (64%) of 77 patients in the landiolol group and in 44 (59%) of 74 in the control group, with serious adverse events (including adverse events leading to death) in nine (12%) of 77 and eight (11%) of 74 patients. Serious adverse events related to landiolol occurred in five (6%) of 77 patients, including blood pressure decreases in three patients (4%) and cardiac arrest, heart rate decrease, and ejection fraction decrease occurred in one patient each (1%).
INTERPRETATION


Landiolol resulted in significantly more patients with sepsis-related tachyarrhythmia achieving a heart rate of 60-94 bpm at 24 h and significantly reduced the incidence of new-onset arrhythmia. Landiolol was also well tolerated, but it should be used under appropriate monitoring of blood pressure and heart rate owing to the risk of hypotension in patients with sepsis and septic shock.
FUNDING


Ono Pharmaceutical Co.",2020,"A significantly larger proportion of patients in the landiolol group had a heart rate of 60-94 bpm 24 h after randomisation than in the control group (55% [41 of 75] vs 33% [25 of 75]), with a between-group difference of 23·1% (95% CI 7·1-37·5; p=0·0031).","['54 hospitals in Japan', 'Patients admitted to the intensive care units who received conventional treatment for sepsis, according to clinical guidelines for the management of sepsis, and who subsequently developed a tachyarrhythmia, were enrolled', 'The main inclusion criteria were 20 years of age or older, diagnosis of sepsis according to Third International Consensus Definitions for Sepsis and Septic Shock criteria, administration of catecholamine necessary to maintain mean arterial pressure at 65 mm Hg or more for at least 1 h, and heart rate of 100 beats per min (bpm) or more maintained for at least 10 min without a change in catecholamine dose with diagnosis of atrial fibrillation, atrial flutter, or sinus tachycardia', 'Between Jan 16, 2018 and Apr 22, 2019', '151 patients', 'Only patients who developed these symptoms and signs within 24 h before randomisation, and within 72 h after entering an intensive care unit', 'patients with sepsis and septic shock', 'patients being treated for sepsis or septic shock']","['Landiolol hydrochloride', 'landiolol', 'conventional sepsis therapy alone (control group) or conventional sepsis therapy plus landiolol (landiolol group) in an open-label manner', 'conventional therapy (Japanese Clinical Practice Guidelines', 'landiolol, an ultra-short-acting β1-selective antagonist']","['incidence of new-onset arrhythmia', 'heart rate', 'proportion of patients with heart rate', 'blood pressure decreases', 'Adverse events', 'cardiac arrest, heart rate decrease, and ejection fraction decrease', 'serious adverse events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0743400', 'cui_str': 'Ejection fraction decreased'}]",151.0,0.299103,"A significantly larger proportion of patients in the landiolol group had a heart rate of 60-94 bpm 24 h after randomisation than in the control group (55% [41 of 75] vs 33% [25 of 75]), with a between-group difference of 23·1% (95% CI 7·1-37·5; p=0·0031).","[{'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Kakihana', 'Affiliation': 'Department of Emergency and Intensive Care Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nishida', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Taniguchi', 'Affiliation': 'Intensive Care Unit, University Hospital, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Okajima', 'Affiliation': 'Intensive Care Unit, University Hospital, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Morimatsu', 'Affiliation': 'Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama City, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Anesthesiology and Pain Relief Center, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Clinical Development Planning, Ono Pharmaceutical Co, Osaka, Japan.'}, {'ForeName': 'Eiichiro', 'Initials': 'E', 'LastName': 'Morishima', 'Affiliation': 'Data Science, Ono Pharmaceutical Co, Osaka, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Matsuda', 'Affiliation': 'Department of Emergency & Critical Care Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: nmatsuda@med.nagoya-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30037-0']
338,31877392,Infant carrying as a tool to promote secure attachments in young mothers: Comparing intervention and control infants during the still-face paradigm.,"Infants of adolescent mothers have a greater risk of developing insecure attachment types and attachment disorders into adulthood. Previous research suggests that skin-to-skin contact predicts secure attachment; however, it is largely unknown whether infant carrying or ""babywearing"" has similar benefits. We hypothesized that adolescent mothers (Mage=19.1 years, SD = 2.0; 40.6 % Hispanic; 40 %< = 11th grade) who were randomly assigned to an infant carrying condition at 2-4 weeks' post-partum (n = 16; 1 h daily for 3 months), compared to a control group (n = 17; reading), would be more likely to have securely attached infants at 7 months (M = 29.0 weeks, SD = 3.4). We coded infant gaze orientation, fretfulness, affect, self-soothing behaviors, and vocalizations in the reunion phase of the Still-Face Paradigm, and used an algorithm derived from the infant Global Rating Scales to determine attachment type. Infants in the intervention condition were more likely to have secure attachments and less likely to have disorganized attachments compared to the control condition. Hours spent babywearing was positively correlated with secure attachment, r pb  = .40, and negatively correlated with disorganized attachment, r pb  =-0.36. There were no statistically significant differences between the conditions or babywearing hours for avoidant or resistant attachment types. The results suggest that infant carrying may be an effective tool at promoting secure attachments, particularly for mothers and infants at greater risk for attachment insecurity.",2020,Infants in the intervention condition were more likely to have secure attachments and less likely to have disorganized attachments compared to the control condition.,"['Infants of adolescent mothers', 'adolescent mothers (Mage=19.1 years, SD = 2.0; 40.6 % Hispanic; 40 %< = 11th grade', 'young mothers']",[],[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]",[],[],,0.055969,Infants in the intervention condition were more likely to have secure attachments and less likely to have disorganized attachments compared to the control condition.,"[{'ForeName': 'Lela Rankin', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'School of Social Work Tucson, Arizona State University, 340 N. Commerce Park Loop, Suite 250, Tucson, AZ 85745, United States. Electronic address: lrw@asu.edu.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Turner', 'Affiliation': 'School of Social Work Tucson, Arizona State University, 340 N. Commerce Park Loop, Suite 250, Tucson, AZ 85745, United States.'}]",Infant behavior & development,['10.1016/j.infbeh.2019.101413']
339,32242760,"Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.","Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet ""app"") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.",2020,"Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided.","['Biospecimen Research', 'three Michigan hospitals to compare two different']","['consent processes (video and interactive tablet ""app"") with standard brochure-based consent in the Michigan BioTrust for Health']","['knowledge scores', 'satisfaction, amount of information, and clarity']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}]",3.0,0.0564352,"Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided.","[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Rothwell', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Johnson', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Goldenberg', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Tarini', 'Affiliation': ""Children's National Hospital, Washington, DC, USA.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Riches', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Louisa A', 'Initials': 'LA', 'LastName': 'Stark', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pries', 'Affiliation': 'Spectrum Health System, Grand Rapids, MI, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Langbo', 'Affiliation': 'InformedDNA, St. Petersburg, FL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Langen', 'Affiliation': 'University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Botkin', 'Affiliation': 'The University of Utah, Salt Lake City, USA.'}]",Journal of empirical research on human research ethics : JERHRE,['10.1177/1556264620913455']
340,31152476,Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study.,"TRANSFORM (TRANSplant eFficacy and safety Outcomes with an eveRolimus-based regiMen) was a 24-month, prospective, open-label trial in 2037 de novo renal transplant recipients randomized (1:1) within 24 hours of transplantation to receive everolimus (EVR) with reduced-exposure calcineurin inhibitor (EVR + rCNI) or mycophenolate with standard-exposure CNI. Consistent with previously reported 12-month findings, noninferiority of the EVR + rCNI regimen for the primary endpoint of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) <50 mL/min per 1.73 m 2  was achieved at month 24 (47.9% vs 43.7%; difference = 4.2%; 95% confidence interval = -0.3, 8.7; P = .006). Mean eGFR was stable up to month 24 (52.6 vs 54.9 mL/min per 1.73 m 2  ) in both arms. The incidence of de novo donor-specific antibodies (dnDSA) was lower in the EVR + rCNI arm (12.3% vs 17.6%) among on-treatment patients. Although discontinuation rates due to adverse events were higher with EVR + rCNI (27.2% vs 15.0%), rates of cytomegalovirus (2.8% vs 13.5%) and BK virus (5.8% vs 10.3%) infections were lower. Cytomegalovirus infection rates were significantly lower with EVR + rCNI even in the D+/R- high-risk group (P < .0001). In conclusion, the EVR + rCNI regimen offers comparable efficacy and graft function with low tBPAR and dnDSA rates and significantly lower incidence of viral infections relative to standard-of-care up to 24 months. Clinicaltrials.gov number: NCT01950819.",2019,The incidence of de novo donor-specific antibodies (dnDSA) was lower in the EVR+rCNI arm (12.3% vs 17.6%) among on-treatment patients.,"['2037 de novo renal transplant recipients (RTxRs) randomized (1:1) within 24 hours of transplantation to receive', 'de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from TRANSFORM study']","['everolimus (EVR) with reduced-exposure calcineurin inhibitor (EVR+rCNI) or mycophenolate with standard-exposure CNI (MPA+sCNI', 'EVR+rCNI']","['Mean eGFR', 'efficacy and graft function with low tBPAR and dnDSA rates', 'Cytomegalovirus infection rates', 'treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR', 'rates of cytomegalovirus', 'incidence of de novo donor-specific antibodies (dnDSA']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C3811844'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}]",2037.0,0.0422096,The incidence of de novo donor-specific antibodies (dnDSA) was lower in the EVR+rCNI arm (12.3% vs 17.6%) among on-treatment patients.,"[{'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sommerer', 'Affiliation': 'Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Tedesco', 'Affiliation': 'Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Chadban', 'Affiliation': 'Department of Renal Medicine and Transplantation, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Shamkant', 'Initials': 'S', 'LastName': 'Mulgaonkar', 'Affiliation': 'Renal and Pancreas Division, Saint Barnabas Medical Center, Livingston, New Jersey.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Qazi', 'Affiliation': 'Division of Nephrology, Keck School of Medicine Renal Transplant Program, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Johan W', 'Initials': 'JW', 'LastName': 'de Fijter', 'Affiliation': 'LUMC Leids Universitair Medisch Centrum, Leiden, The Netherlands.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Oppenheimer', 'Affiliation': 'Department of Nephrology and Renal Transplantation, Renal Transplant Unit, Hospital Clinic of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': 'Hospital Universitari De Bellvitge, IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Watarai', 'Affiliation': 'Department of Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya-City, Aichi, Japan.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Massari', 'Affiliation': 'Hospital Privado Centro Medico de Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Legendre', 'Affiliation': 'Department of Kidney Transplantation, Adult Transplantation Service, Paris Descartes University and Necker Hospital, Paris, France.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Citterio', 'Affiliation': 'Agostino Gemelli University Polyclinic Foundation, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Henry', 'Affiliation': 'Department of Surgery, The Comprehensive Transplant Center, The Ohio State University, Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Titte R', 'Initials': 'TR', 'LastName': 'Srinivas', 'Affiliation': 'Division of Nephrology, Medical University of South Carolina, Mount Pleasant, South Carolina.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Vincenti', 'Affiliation': 'Department of Surgery, Kidney Transplant Service, University of California, San Francisco, California.'}, {'ForeName': 'Maria Pilar Hernandez', 'Initials': 'MPH', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ana Maria', 'Initials': 'AM', 'LastName': 'Marti', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bernhardt', 'Affiliation': 'Department of Research and Development, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Department of Nephrology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15480']
341,32241670,A Randomized Cross-Over Trial Focused on Clinical Breast Exam Skill Acquisition Using High Fidelity versus Low Fidelity Simulation Models in Rwanda.,"OBJECTIVE


Breast cancer incidence is rising for women in low and middle income country (LMIC)s. Growing the health care workforce trained in clinical breast exam (CBE) is critical to mitigating breast cancer globally. We developed a CBE simulation training course and determined whether training on a low-fidelity (LF) simulation model results in similar skill acquisition as training on high-fidelity (HF) models in Rwanda.
DESIGN


A single-center randomized educational crossover trial was implemented. A preintervention baseline exam (exam 1), followed by a lecture series (exam 2), and training sessions with assigned simulation models was implemented (exam 3)-participants then crossed over to their unassigned model (exam 4). The primary outcome of this study determined mean difference in CBE exam scores between HF and LF groups. Secondary outcomes identified any provider level traits and changes in overall scores.
SETTING


The study was implemented at the University Teaching Hospital, Kigali (CHUK) in Rwanda, Africa from July 2014 to March 2015 PARTICIPANTS: Medical students, residents in surgery, obstetrics and gynecology, and internal medicine residents participated in a 1-day CBE simulation training course.
RESULTS


A total of 107 individuals were analyzed in each arm of the study. Mean difference in exam scores between HF and LF models in exam 1 to 4 was not significantly different (exam 1 0.08 standard error (SE) = 0.47, p = 0.42; exam 2 0.86, SE = 0.69, p = 0.16; exam 3 0.03, SE = 0.38, p = 0.66; exam 4 0.10 SE = 0.37, p = 0.29). Overall exam scores improved from pre- to post-intervention.
CONCLUSIONS


Mean difference in exams scores were not significantly different between participants trained with HF versus LF models. LF models can be utilized as cost effective teaching tools for CBE skill acquisition, in resource poor areas.",2020,"Mean difference in exam scores between HF and LF models in exam 1 to 4 was not significantly different (exam 1 0.08 standard error (SE) = 0.47, p = 0.42; exam 2 0.86, SE = 0.69, p = 0.16; exam 3 0.03, SE = 0.38, p = 0.66;","[' Medical students, residents in surgery, obstetrics and gynecology, and internal medicine residents participated in a', 'Rwanda', 'A total of 107 individuals were analyzed in each arm of the study', 'women in low and middle income country (LMIC)s', 'The study was implemented at the University Teaching Hospital, Kigali (CHUK) in Rwanda, Africa from July 2014 to March 2015 PARTICIPANTS']",['1-day CBE simulation training course'],"['provider level traits and changes in overall scores', 'CBE exam scores', 'Overall exam scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]",107.0,0.0315952,"Mean difference in exam scores between HF and LF models in exam 1 to 4 was not significantly different (exam 1 0.08 standard error (SE) = 0.47, p = 0.42; exam 2 0.86, SE = 0.69, p = 0.16; exam 3 0.03, SE = 0.38, p = 0.66;","[{'ForeName': 'Shilpa Shree', 'Initials': 'SS', 'LastName': 'Murthy', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts; Indiana University, Bloomington, Indiana. Electronic address: shilpamurthy83@gmail.com.""}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Ntakiyiruta', 'Affiliation': 'University of Rwanda, Department of Surgery, Rwanda.'}, {'ForeName': 'Faustin', 'Initials': 'F', 'LastName': 'Ntirenganya', 'Affiliation': 'University of Rwanda, Department of Surgery, Rwanda.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Ingabire', 'Affiliation': 'University of Rwanda, Department of Surgery, Rwanda.'}, {'ForeName': 'Sara Kikut', 'Initials': 'SK', 'LastName': 'Defregger', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts; Indiana University, Bloomington, Indiana; University of Rwanda, Department of Surgery, Rwanda; Massachusetts General Hospital, Boston, Massachusetts; Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Gally', 'Initials': 'G', 'LastName': 'Reznor', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Stu', 'Initials': 'S', 'LastName': 'Lipitz', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Susan Lynn', 'Initials': 'SL', 'LastName': 'Troyan', 'Affiliation': ""Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Sughra', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': ""Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dunnington', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riviello', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, Boston, Massachusetts; University of Rwanda, Department of Surgery, Rwanda.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.030']
342,32227128,"Association of Sex With Severity of Coronary Artery Disease, Ischemia, and Symptom Burden in Patients With Moderate or Severe Ischemia: Secondary Analysis of the ISCHEMIA Randomized Clinical Trial.","Importance


While many features of stable ischemic heart disease vary by sex, differences in ischemia, coronary anatomy, and symptoms by sex have not been investigated among patients with moderate or severe ischemia. The enrolled ISCHEMIA trial cohort that underwent coronary computed tomographic angiography (CCTA) was required to have obstructive coronary artery disease (CAD) for randomization.
Objective


To describe sex differences in stress testing, CCTA findings, and symptoms in ISCHEMIA trial participants.
Design, Setting, and Participants


This secondary analysis of the multicenter ISCHEMIA randomized clinical trial analyzed baseline characteristics of patients with stable ischemic heart disease. Individuals were enrolled from July 2012 to January 2018 based on local reading of moderate or severe ischemia on a stress test, after which blinded CCTA was performed in most. Core laboratories reviewed stress tests and CCTAs. Participants with no obstructive CAD or with left main CAD of 50% or greater were excluded. Those who met eligibility criteria including CCTA (if performed) were randomized to a routine invasive or a conservative management strategy (N = 5179). Angina was assessed using the Seattle Angina Questionnaire. Analysis began October 1, 2018.
Interventions


CCTA and angina assessment.
Main Outcomes and Measures


Sex differences in stress test, CCTA findings, and symptom severity.
Results


Of 8518 patients enrolled, 6256 (77%) were men. Women were more likely to have no obstructive CAD (<50% stenosis in all vessels on CCTA) (353 of 1022 [34.4%] vs 378 of 3353 [11.3%]). Of individuals who were randomized, women had more angina at baseline than men (median [interquartile range] Seattle Angina Questionnaire Angina Frequency score: 80 [70-100] vs 90 [70-100]). Women had less severe ischemia on stress imaging (383 of 919 [41.7%] vs 1361 of 2972 [45.9%] with severe ischemia; 386 of 919 [42.0%] vs 1215 of 2972 [40.9%] with moderate ischemia; and 150 of 919 [16.4%] vs 394 of 2972 [13.3%] with mild or no ischemia). Ischemia was similar by sex on exercise tolerance testing. Women had less extensive CAD on CCTA (205 of 568 women [36%] vs 1142 of 2418 men [47%] with 3-vessel disease; 184 of 568 women [32%] vs 754 of 2418 men [31%] with 2-vessel disease; and 178 of 568 women [31%] vs 519 of 2418 men [22%] with 1-vessel disease). Female sex was independently associated with greater angina frequency (odds ratio, 1.41; 95% CI, 1.13-1.76).
Conclusions and Relevance


Women in the ISCHEMIA trial had more frequent angina, independent of less extensive CAD, and less severe ischemia than men. These findings reflect inherent sex differences in the complex relationships between angina, atherosclerosis, and ischemia that may have implications for testing and treatment of patients with suspected stable ischemic heart disease.
Trial Registration


ClinicalTrials.gov Identifier: NCT01471522.",2020,Women had less severe ischemia on stress imaging (383 of 919 [41.7%] vs 1361 of 2972 [45.9%] with severe ischemia; 386 of 919 [42.0%] vs 1215 of 2972 [40.9%] with moderate ischemia; and 150 of 919 [16.4%] vs 394 of 2972 [13.3%] with mild or no ischemia).,"['patients with suspected stable ischemic heart disease', 'Individuals were enrolled from July 2012 to January 2018 based on local reading of moderate or severe ischemia on a stress test, after which blinded CCTA was performed in most', 'patients with stable ischemic heart disease', 'patients with moderate or severe ischemia', 'Participants with no obstructive CAD or with left main CAD of 50% or greater were excluded', 'Women had less extensive CAD on CCTA (205 of 568 women [36%] vs 1142 of 2418 men [47%] with 3-vessel disease; 184 of 568 women [32%] vs 754 of 2418 men [31%] with 2-vessel disease; and 178 of 568 women [31%] vs 519 of 2418 men [22%] with 1-vessel disease', 'Patients With Moderate or Severe Ischemia', '8518 patients enrolled, 6256 (77%) were men', 'Of individuals who were randomized, women had more angina at baseline than men (median [interquartile range] Seattle Angina Questionnaire Angina Frequency score: 80 [70-100] vs 90 [70-100']","['coronary computed tomographic angiography (CCTA', 'routine invasive or a conservative management strategy']","['obstructive CAD', 'angina frequency', 'severe ischemia', 'Measures\n\n\nSex differences in stress test, CCTA findings, and symptom severity', 'Ischemia', 'severe ischemia on stress imaging', 'Seattle Angina Questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036866', 'cui_str': 'Sexual Dimorphism'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",8518.0,0.20527,Women had less severe ischemia on stress imaging (383 of 919 [41.7%] vs 1361 of 2972 [45.9%] with severe ischemia; 386 of 919 [42.0%] vs 1215 of 2972 [40.9%] with moderate ischemia; and 150 of 919 [16.4%] vs 394 of 2972 [13.3%] with mild or no ischemia).,"[{'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': 'UMKC School of Medicine, Kansas City, Missouri.'}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': 'St Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'C Noel', 'Initials': 'CN', 'LastName': 'Bairey-Merz', 'Affiliation': 'Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Cyr', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz. Idipaz. UAM. CIBER-CV, Madrid, Spain.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': 'National Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Rajesh Gopalan', 'Initials': 'RG', 'LastName': 'Nair', 'Affiliation': 'Government Medical College, Kerla, India.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': 'National Research Center for Cardiovascular Surgery, Moscow, Russia.'}, {'ForeName': 'Jiyan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E.Meshalkin National medical research center of the Ministry of Health of the Russian Federation (E.Meshalkin NMRC), Moscow, Russia.'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Sasa B', 'Initials': 'SB', 'LastName': 'Hinic', 'Affiliation': 'UHC Bezanijska kosa, Belgrade, Serbia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jaroch', 'Affiliation': 'Wroclaw Medical University, T. Marciniak Hospital, Wroclaw, Poland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hoye', 'Affiliation': 'The University of Hull/Castle Hill Hospital, Cottingham, United Kingdom.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Berger', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': 'VA New England Healthcare System/Boston, Boston, Massachusetts.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2020.0822']
343,32147870,Shared Decision Making for Syncope in the Emergency Department: A Randomized Controlled Feasibility Trial.,"OBJECTIVES


Significant practice variation is seen in the management of syncope in the emergency department (ED). We sought to evaluate the feasibility of performing a randomized controlled trial of a shared decision making (SDM) tool for low-to-intermediate-risk syncope patients presenting to the ED.
METHODS


We performed a randomized controlled trial of adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States. Patients with a serious diagnosis identified in the ED were excluded. Patients were randomized, 1:1, to receive either usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM. Our primary outcome was feasibility, i.e., ability to enroll 50 patients in 24 months. Secondary outcomes included patient knowledge, involvement (measured with OPTION-5), rating of care, and clinical outcomes at 30 days post-ED visit.
RESULTS


After screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019. The most common reason for exclusion was lack of clinical equipoise to justify SDM (n = 124). Patients in the SynDA arm tended to have greater patient involvement, as shown by higher OPTION-5 scores: 52/100 versus 27/100 (between-group difference = -25.4, 95% confidence interval = -13.5 to -37.3). Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days.
CONCLUSIONS


Among ED patients with unexplained syncope, a randomized controlled trial of a shared decision-making tool is feasible. Although this study was not powered to detect differences in clinical outcomes, it demonstrates feasibility, while providing key lessons and effect sizes that could inform the design of future SDM trials.",2020,"Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days.
","['adults (≥30 years) with unexplained syncope who presented to an academic ED in the United States', 'After screening 351 patients, we enrolled 50 participants with unexplained syncope from January 2017 to January 2019', 'ED patients with unexplained syncope', 'low-to-intermediate risk syncope patients presenting to the ED', 'Patients with a serious diagnosis identified in the ED were excluded']","['usual care or a personalized syncope decision aid (SynDA) meant to facilitate SDM', 'shared decision-making (SDM) tool']","['clinical knowledge, ratings of care, and serious clinical outcomes', 'patient knowledge, involvement (measured with OPTION-5), and rating of care; and clinical outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",50.0,0.244095,"Both groups had similar levels of clinical knowledge, ratings of care, and serious clinical outcomes at 30 days.
","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Probst', 'Affiliation': 'From the, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Lin', 'Affiliation': 'From the, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Sze', 'Affiliation': 'From the, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Erik P', 'Initials': 'EP', 'LastName': 'Hess', 'Affiliation': 'the, Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Breslin', 'Affiliation': 'the, School of Visual Arts, New York, NY.'}, {'ForeName': 'Dominick L', 'Initials': 'DL', 'LastName': 'Frosch', 'Affiliation': 'the, Palo Alto Medical Foundation Research Institute, Palo Alto, CA.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Sun', 'Affiliation': 'the, Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Marie-Noelle', 'Initials': 'MN', 'LastName': 'Langan', 'Affiliation': 'and the, Division of Cardiology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Thiruganasambandamoorthy', 'Affiliation': 'and the, Department of Emergency Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Lynne D', 'Initials': 'LD', 'LastName': 'Richardson', 'Affiliation': 'From the, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13955']
344,31577036,Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial.,"Importance


High-flow nasal oxygen may prevent postextubation respiratory failure in the intensive care unit (ICU). The combination of high-flow nasal oxygen with noninvasive ventilation (NIV) may be an optimal strategy of ventilation to avoid reintubation.
Objective


To determine whether high-flow nasal oxygen with prophylactic NIV applied immediately after extubation could reduce the rate of reintubation, compared with high-flow nasal oxygen alone, in patients at high risk of extubation failure in the ICU.
Design, Setting, and Participants


Multicenter randomized clinical trial conducted from April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018.
Interventions


Patients were randomly assigned to high-flow nasal oxygen alone (n = 306) or high-flow nasal oxygen alternating with NIV (n = 342) immediately after extubation.
Main Outcomes and Measures


The primary outcome was the proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality.
Results


Among 648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial. The reintubation rate at day 7 was 11.8% (95% CI, 8.4%-15.2%) (40/339) with high-flow nasal oxygen and NIV and 18.2% (95% CI, 13.9%-22.6%) (55/302) with high-flow nasal oxygen alone (difference, -6.4% [95% CI, -12.0% to -0.9%]; P = .02). Among the 11 prespecified secondary outcomes, 6 showed no significant difference. The proportion of patients with postextubation respiratory failure at day 7 (21% vs 29%; difference, -8.7% [95% CI, -15.2% to -1.8%]; P = .01) and reintubation rates up until ICU discharge (12% vs 20%, difference -7.4% [95% CI, -13.2% to -1.8%]; P = .009) were significantly lower with high-flow nasal oxygen and NIV than with high-flow nasal oxygen alone. ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).
Conclusions and Relevance


In mechanically ventilated patients at high risk of extubation failure, the use of high-flow nasal oxygen with NIV immediately after extubation significantly decreased the risk of reintubation compared with high-flow nasal oxygen alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT03121482.",2019,"ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).
","['648 patients who were randomized (mean [SD] age, 70 [10] years; 219 women [34%]), 641 patients completed the trial', 'Patients at High Risk of Extubation Failure', 'patients at high risk of extubation failure in the ICU', 'April 2017 to January 2018 among 641 patients at high risk of extubation failure (ie, older than 65 years or with an underlying cardiac or respiratory disease) at 30 ICUs in France; follow-up was until April 2018', 'mechanically ventilated patients at high risk of extubation failure']","['Postextubation High-Flow Nasal Oxygen', 'high-flow nasal oxygen with noninvasive ventilation (NIV', 'Noninvasive Ventilation', 'High-Flow Nasal Oxygen Alone', 'high-flow nasal oxygen alone (n\u2009=\u2009306) or high-flow nasal oxygen with NIV (n\u2009=\u2009342) immediately after extubation']","['reintubation rates up until ICU discharge', 'ICU mortality rates', 'postextubation respiratory failure', 'rate of reintubation', 'reintubation rate', 'proportion of patients with postextubation respiratory failure', 'proportion of patients reintubated at day 7; secondary outcomes included postextubation respiratory failure at day 7, reintubation rates up until ICU discharge, and ICU mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",641.0,0.287349,"ICU mortality rates were not significantly different: 6% with high-flow nasal oxygen and NIV and 9% with high-flow nasal oxygen alone (difference, -2.4% [95% CI, -6.7% to 1.7%]; P = .25).
","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Muller', 'Affiliation': ""Groupe Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Maxens', 'Initials': 'M', 'LastName': 'Decavèle', 'Affiliation': 'Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, AP-HP, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France.'}, {'ForeName': 'Séverin', 'Initials': 'S', 'LastName': 'Cabasson', 'Affiliation': 'Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Le Meur', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, AP-HP, INSERM, Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Razazi', 'Affiliation': 'Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, AP-HP, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, CIC 1415, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, Tours, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sabatier', 'Affiliation': 'Centre Hospitalier de Pau, Service de Réanimation, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France.'}, {'ForeName': 'Pierre-Éric', 'Initials': 'PÉ', 'LastName': 'Danin', 'Affiliation': 'Centre Hospitalier Universitaire de Nice, Réanimation Médico-Chirurgicale Archet 2, INSERM U 1065, Nice, France.'}, {'ForeName': 'Hodanou', 'Initials': 'H', 'LastName': 'Nanadoumgar', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Réanimation Chirurgicale, Poitiers, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Gibelin', 'Affiliation': 'Hôpital Tenon, Réanimation et USC médico-chirurgicale, CARMAS, AP-HP, Faculté de médecine Sorbonne Université, Collegium Galilée, Paris, France.'}, {'ForeName': 'Lassane', 'Initials': 'L', 'LastName': 'Zanre', 'Affiliation': 'Centre Hospitalier Emile Roux, Service de Réanimation, Le Puy en Velay, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Deye', 'Affiliation': 'Hôpital Lariboisière, Réanimation Médicale et Toxicologique, AP-HP, INSERM UMR-S 942, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Maamar', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Groupe Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.14901']
345,31826731,Neuroimaging in Ischemic Stroke Is Different Between Men and Women in the DEFUSE 3 Cohort.,"Background and Purpose- Clinical deficits from ischemic stroke are more severe in women, but the pathophysiological basis of this sex difference is unknown. Sex differences in core and penumbral volumes and their relation to outcome were assessed in this substudy of the DEFUSE 3 clinical trial (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke). Methods- DEFUSE 3 randomized patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging. Using univariate and adjusted regression models, the effect of sex was assessed on prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans. Results- All patients were included in the analysis (n=182) with 90 men and 92 women. There was no sex difference in the site of baseline arterial occlusion. Adjusted by age, baseline National Institutes of Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes than men. Median (interquartile range) volumes for core were 8.0 mL (1.9-18.4) in women versus 12.6 mL (2.7-29.6) in men, for T max >6 seconds 89.0 mL (63.8-131.7) versus 133.9 mL (87.0-175.4), and for mismatch 82.1mL (53.8-112.8) versus 108.2 (64.1-149.2). The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57),  P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003). Conclusions- In the large vessel ischemic stroke cohort selected for DEFUSE 3, women had imaging evidence of better collateral circulation, smaller baseline core volumes, and slower ischemic core growth. These observations suggest sex differences in hemodynamic and temporal features of anterior circulation large artery occlusions. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.",2020,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57),  P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","['All patients were included in the analysis (n=182) with 90 men and 92 women', 'Men and Women in the DEFUSE 3 Cohort', 'patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging']","[' and Purpose', 'Conclusions', 'Methods']","['prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans', 'Median (interquartile range) volumes', 'Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes', 'hypoperfusion intensity ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1275506', 'cui_str': 'Imaging modality'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",182.0,0.369744,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57),  P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","[{'ForeName': 'Adrienne N', 'Initials': 'AN', 'LastName': 'Dula', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Zuck', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Warach', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028205']
346,32236507,Quality of Surgery and Outcome in Localized Gastrointestinal Stromal Tumors Treated Within an International Intergroup Randomized Clinical Trial of Adjuvant Imatinib.,"Importance


The association between quality of surgery and overall survival in patients affected by localized gastrointestinal stromal tumors (GIST) is not completely understood.
Objective


To assess the risk of death with and without imatinib according to microscopic margins status (R0/R1) using data from a randomized study on adjuvant imatinib.
Design, Setting, and Participants


This is a post hoc observational study on patients included in the randomized, open-label, phase III trial, performed between December 2004 and October 2008. Median follow-up was 9.1 years (IQR, 8-10 years). The study was performed at 112 hospitals in 12 countries. Inclusion criteria were diagnosis of primary GIST, with intermediate or high risk of relapse; no evidence of residual disease after surgery; older than 18 years; and no prior malignancies or concurrent severe/uncontrolled medical conditions. Data were analyzed between July 17, 2017, and March 1, 2020.
Interventions


Patients were randomized after surgery to either receive imatinib (400 mg/d) for 2 years or no adjuvant treatment. Randomization was stratified by center, risk category (high vs intermediate), tumor site (gastric vs other), and quality of surgery (R0 vs R1). Tumor rupture was included in the R1 category but also analyzed separately.
Main Outcomes and Measures


Primary end point of this substudy was overall survival (OS), estimated using Kaplan-Meier method and compared between R0/R1 using Cox models adjusted for treatment and stratification factors.
Results


A total of 908 patients were included; 51.4% were men (465) and 48.6% were women (440), and the median age was 59 years (range, 18-89 years). One hundred sixty-two (17.8%) had an R1 resection, and 97 of 162 (59.9%) had tumor rupture. There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib). When tumor rupture was excluded, this difference in OS between R1 and R0 resections disappeared (HR, 1.05; 95% CI, 0.54-2.01).
Conclusions and Relevance


The difference in OS by quality of surgery with or without imatinib was associated with the presence of tumor rupture. When the latter was excluded, the presence of R1 margins was not associated with worse OS.
Trial Registration


ClinicalTrials.gov Identifier: NCT00103168.",2020,"There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib).","['112 hospitals in 12 countries', 'patients included in the randomized, open-label, phase III trial, performed between December 2004 and October 2008', 'patients affected by localized gastrointestinal stromal tumors (GIST', 'Inclusion criteria were diagnosis of primary GIST, with intermediate or high risk of relapse; no evidence of residual disease after surgery; older than 18 years; and no prior malignancies or concurrent severe/uncontrolled medical conditions', 'A total of 908 patients were included; 51.4% were men (465) and 48.6% were women (440), and the median age was 59 years (range, 18-89 years', 'Localized Gastrointestinal Stromal Tumors']","['Adjuvant Imatinib', 'imatinib']","['quality of surgery and overall survival', 'overall survival (OS), estimated using Kaplan-Meier method and compared between R0/R1 using Cox models adjusted for treatment and stratification factors', 'R1 resection', 'tumor rupture', 'Tumor rupture', 'OS', 'OS between R1 and R0 resections']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1321660', 'cui_str': 'Fosamprenavir calcium'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2938957', 'cui_str': 'Tumour rupture'}]",908.0,0.235474,"There was a significant difference in OS for patients undergoing an R1 vs R0 resection, overall (hazard ratio [HR], 2.05; 95% CI, 1.45-2.89) and by treatment arm (HR, 2.65; 95% CI, 1.37-3.75 with adjuvant imatinib and HR, 1.86; 95% CI, 1.16-2.99 without adjuvant imatinib).","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Institute Curie, Paris, France.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Poveda Velasco', 'Affiliation': 'Instituto Valenciano De Oncologia, Valencia, Spain.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Kotasek', 'Affiliation': 'Adelaide Cancer Centre, Kurralta Park, and Division of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fumagalli', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Judson', 'Affiliation': 'Royal Marsden Hospital, London, England.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Coevorden', 'Affiliation': 'The Netherland Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Medizinische Universitätsklinik II, Tübingen, Germany.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Duffaud', 'Affiliation': 'Hôpital La Timone, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Javier Martin', 'Initials': 'JM', 'LastName': 'Broto', 'Affiliation': 'Hospital Universitario Viergen del Rocio Sevilla, Seville, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marréaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Smithers', 'Affiliation': 'Princess Alexandra Hospital, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Institute Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Facundo', 'Initials': 'F', 'LastName': 'Zaffaroni', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Litière', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, NetSARC and LYRIC, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Paolo G', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.'}]",JAMA surgery,['10.1001/jamasurg.2020.0397']
347,32236950,A five-year follow-up of untreated patients with chronic lymphocytic leukaemia treated with ofatumumab and chlorambucil: final analysis of the Complement 1 phase 3 trial.,"The Complement 1 trial investigated the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia (CLL). On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free survival, respectively. A high rate (61%) of treatment with next-line therapies in both the treatment arms may dilute any potential OS difference and confound the interpretation of the OS results. Addition of ofatumumab to chlorambucil demonstrated clinical benefit and tolerability as a frontline treatment option in patients unfit for fludarabine-containing therapy, with no new safety concerns.",2020,"On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free survival, respectively.","['patients unfit for fludarabine-containing therapy, with no new safety concerns', 'untreated patients with chronic lymphocytic leukaemia treated with', 'patients with previously untreated chronic lymphocytic leukaemia (CLL']","['chlorambucil', 'ofatumumab\xa0+\xa0chlorambucil with chlorambucil monotherapy', 'ofatumumab and chlorambucil']","['efficacy and safety', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0643273,"On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free survival, respectively.","[{'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Department of Hematology, University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Haematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Govind Babu', 'Affiliation': 'Department of Medical Oncology, Kidwai Memorial Institute of Oncology, HCG Hospitals, Bangalore, India.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Kloczko', 'Affiliation': 'Department of Hematology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine, Haematology and Oncology, Masaryk University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Panagiotidis', 'Affiliation': 'Haematology Department, Department of Internal Medicine University of Athens, Laikon General Hospital, National and Kapodistrian University of Athens Medical School, Athens, Greece.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': 'Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Werner', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Vincent', 'Affiliation': 'Novartis Pharma S.A.S, Paris, France.'}, {'ForeName': 'Sadhvi', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'Novartis Pharma S.A.S, Paris, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}]",British journal of haematology,['10.1111/bjh.16625']
348,32016310,Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials.,"Importance


Intravenous iron enables rapid correction of iron-deficiency anemia, but certain formulations induce fibroblast growth factor 23-mediated hypophosphatemia.
Objective


To compare risks of hypophosphatemia and effects on biomarkers of mineral and bone homeostasis of intravenous iron isomaltoside (now known as ferric derisomaltose) vs ferric carboxymaltose.
Design, Setting, and Participants


Between October 2017 and June 2018, 245 patients aged 18 years and older with iron-deficiency anemia (hemoglobin level ≤11 g/dL; serum ferritin level ≤100 ng/mL) and intolerance or unresponsiveness to 1 month or more of oral iron were recruited from 30 outpatient clinic sites in the United States into 2 identically designed, open-label, randomized clinical trials. Patients with reduced kidney function were excluded. Serum phosphate and 12 additional biomarkers of mineral and bone homeostasis were measured on days 0, 1, 7, 8, 14, 21, and 35. The date of final follow-up was June 19, 2018, for trial A and May 29, 2018, for trial B.
Interventions


Intravenous administration of iron isomaltoside, 1000 mg, on day 0 or ferric carboxymaltose, 750 mg, infused on days 0 and 7.
Main Outcomes and Measures


The primary end point was the incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) between baseline and day 35.
Results


In trial A, 123 patients were randomized (mean [SD] age, 45.1 [11.0] years; 95.9% women), including 62 to iron isomaltoside and 61 to ferric carboxymaltose; 95.1% completed the trial. In trial B, 122 patients were randomized (mean [SD] age, 42.6 [12.2] years; 94.1% women), including 61 to iron isomaltoside and 61 to ferric carboxymaltose; 93.4% completed the trial. The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose (trial A: 7.9% vs 75.0% [adjusted rate difference, -67.0% {95% CI, -77.4% to -51.5%}], P < .001; trial B: 8.1% vs 73.7% [adjusted rate difference, -65.8% {95% CI, -76.6% to -49.8%}], P < .001). Beyond hypophosphatemia and increased parathyroid hormone, the most common adverse drug reactions (No./total No.) were nausea (iron isomaltoside: 1/125; ferric carboxymaltose: 8/117) and headache (iron isomaltoside: 4/125; ferric carboxymaltose: 5/117).
Conclusions and Relevance


In 2 randomized trials of patients with iron-deficiency anemia who were intolerant of or unresponsive to oral iron, iron isomaltoside (now called ferric derisomaltose), compared with ferric carboxymaltose, resulted in lower incidence of hypophosphatemia over 35 days. However, further research is needed to determine the clinical importance of this difference.
Trial Registration


ClinicalTrials.gov Identifiers: NCT03238911 and NCT03237065.",2020,"The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose (trial A: 7.9% vs 75.0% [adjusted rate difference, -67.0% {95% CI, -77.4% to -51.5%}], P < .001; trial B: 8.1% vs 73.7% [adjusted rate difference, -65.8% {95% CI, -76.6% to -49.8%}], P < .001).","['Patients with reduced kidney function', 'patients with iron-deficiency anemia who were intolerant of or unresponsive to oral iron, iron isomaltoside (now called ferric derisomaltose', '123 patients were randomized (mean [SD] age, 45.1 [11.0] years; 95.9% women), including 62 to iron isomaltoside and 61 to ferric carboxymaltose; 95.1% completed the trial', 'Hypophosphatemia in Iron-Deficiency Anemia', 'Participants\n\n\nBetween October 2017 and June 2018, 245 patients aged 18 years and older with iron-deficiency anemia (hemoglobin level ≤11', '122 patients were randomized (mean [SD] age, 42.6 [12.2] years; 94.1% women), including 61 to iron isomaltoside and 61 to ferric carboxymaltose; 93.4% completed the trial']","['iron isomaltoside vs ferric carboxymaltose', 'ferric carboxymaltose', 'iron isomaltoside', 'intravenous iron isomaltoside', 'Iron Isomaltoside vs Ferric Carboxymaltose']","['Serum phosphate and 12 additional biomarkers of mineral and bone homeostasis', 'parathyroid hormone', 'nausea', 'headache', 'incidence of hypophosphatemia (serum phosphate level', 'incidence of hypophosphatemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",123.0,0.446537,"The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose (trial A: 7.9% vs 75.0% [adjusted rate difference, -67.0% {95% CI, -77.4% to -51.5%}], P < .001; trial B: 8.1% vs 73.7% [adjusted rate difference, -65.8% {95% CI, -76.6% to -49.8%}], P < .001).","[{'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Duke Clinical Research Institute, Division of Nephrology, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Rubin', 'Affiliation': 'Division of Endocrinology, Department of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Achebe', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Econs', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Munro', 'Initials': 'M', 'LastName': 'Peacock', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Imel', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-clinical Research, Pharmacosmos A/S, Holbæk, Denmark.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Carpenter', 'Affiliation': 'Department of Pediatrics (Endocrinology), Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Brandenburg', 'Affiliation': 'Rhein-Maas Klinikum Würselen, Würselen, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Zoller', 'Affiliation': 'Department of Medicine I, Medical University of Innsbruck, Innsbruck, Austria.'}]",JAMA,['10.1001/jama.2019.22450']
349,32016532,Methylnaltrexone for the treatment of opioid-induced constipation and gastrointestinal stasis in intensive care patients. Results from the MOTION trial.,"PURPOSE


Constipation can be a significant problem in critically unwell patients, associated with detrimental outcomes. Opioids are thought to contribute to the mechanism of bowel dysfunction. We tested if methylnaltrexone, a pure peripheral mu-opioid receptor antagonist, could reverse opioid-induced constipation.
METHODS


The MOTION trial is a multi-centre, double blind, randomised placebo-controlled trial to investigate whether methylnaltrexone alleviates opioid-induced constipation (OIC) in critical care patients. Eligibility criteria included adult ICU patients who were mechanically ventilated, receiving opioids and were constipated (had not opened bowels for a minimum 48 h) despite prior administration of regular laxatives as per local bowel management protocol. The primary outcome was time to significant rescue-free laxation. Secondary outcomes included gastric residual volume, tolerance of enteral feeds, requirement for rescue laxatives, requirement for prokinetics, average number of bowel movements per day, escalation of opioid dose due to antagonism/reversal of analgesia, incidence of ventilator-associated pneumonia, incidence of diarrhoea and Clostridium difficile infection and finally 28 day, ICU and hospital mortality.
RESULTS


A total of 84 patients were enrolled and randomized (41 to methylnaltrexone and 43 to placebo). The baseline demographic characteristics of the two groups were generally well balanced. There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22). There were no significant differences in the majority of secondary outcomes, particularly days 1-3. However, during days 4-28, there were fewer median number of bowel movements per day in the methylnaltrexone group, (p = 0.01) and a greater incidence of diarrhoea in the placebo group (p = 0.02). There was a marked difference in mortality between the groups, with ten deaths in the methylnaltrexone group and two in the placebo group during days 4-28 (p = 0.007).
CONCLUSION


We found no evidence to support the addition of methylnaltrexone to regular laxatives for the treatment of opioid-induced constipation in critically ill patients; however, the confidence interval was wide and a clinically important difference cannot be excluded.",2020,"There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22).","['critical care patients', '84 patients were enrolled and randomized (41 to', 'intensive care patients', 'Eligibility criteria included adult ICU patients who were mechanically ventilated, receiving opioids and were constipated (had not opened bowels for a minimum 48\xa0h) despite prior administration of regular laxatives as per local bowel management protocol']","['methylnaltrexone and 43 to placebo', 'methylnaltrexone alleviates opioid-induced constipation (OIC', 'Methylnaltrexone', 'placebo', 'methylnaltrexone']","['median number of bowel movements', 'time to rescue-free laxation', 'constipation and gastrointestinal stasis', 'mortality', 'gastric residual volume, tolerance of enteral feeds, requirement for rescue laxatives, requirement for prokinetics, average number of bowel movements per day, escalation of opioid dose due to antagonism/reversal of analgesia, incidence of ventilator-associated pneumonia, incidence of diarrhoea and Clostridium difficile infection and finally 28\xa0day, ICU and hospital mortality', 'incidence of diarrhoea', 'time to significant rescue-free laxation']","[{'cui': 'C0010337', 'cui_str': 'Critical Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0066411', 'cui_str': 'methylnaltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0333138', 'cui_str': 'Stasis (morphologic abnormality)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3665864', 'cui_str': 'Gastric residuals'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",84.0,0.631063,"There was no significant difference in time to rescue-free laxation between the groups (Hazard ratio 1.42, 95% CI 0.82-2.46, p = 0.22).","[{'ForeName': 'Parind B', 'Initials': 'PB', 'LastName': 'Patel', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK. parind.patel@nhs.net.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Brett', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Callaghan"", 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Anjum', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Cross', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Centre for Perioperative Medicine and Critical Care Research, Imperial College Healthcare NHS Trust, London, UK.'}]",Intensive care medicine,['10.1007/s00134-019-05913-6']
350,32239210,Effect of Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy on Local Recurrence and Survival: Long-term Results From the TARGIT-A Randomized Clinical Trial in Early Breast Cancer.,"Importance


Conventional adjuvant radiotherapy for breast cancer given daily for several weeks is onerous and expensive. Some patients may be obliged to choose a mastectomy instead, and some may forgo radiotherapy altogether. We proposed a clinical trial to test whether radiotherapy could be safely limited to the tumor bed.
Objective


To determine whether delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT) is noninferior to whole-breast external beam radiotherapy (EBRT) in terms of local control.
Design, Setting, and Participants


In this prospective, randomized (1:1 ratio) noninferiority trial, 1153 patients aged 45 years or older with invasive ductal breast carcinoma smaller than 3.5 cm treated with breast conservation were enrolled from 28 centers in 9 countries. Data were locked in on July 3, 2019.
Interventions


The TARGIT-A trial was started in March 2000; patients were randomized after needle biopsy to receive TARGIT-IORT immediately after lumpectomy under the same anesthetic vs EBRT and results have been shown to be noninferior. A parallel study, described in this article, was initiated in 2004; patients who had their cancer excised were randomly allocated using separate randomization tables to receive EBRT or delayed TARGIT-IORT given as a second procedure by reopening the lumpectomy wound.
Main Outcomes and Measures


A noninferiority margin for local recurrence rate of 2.5% at 5 years, and long-term survival outcomes.
Results


Overall, 581 women (mean [SD] age, 63 [7] years) were randomized to delayed TARGIT-IORT and 572 patients (mean [SD] age, 63 [8] years) were randomized to EBRT. Sixty patients (5%) had tumors larger than 2 cm, or had positive nodes and only 32 (2.7%) were younger than 50 years. Delayed TARGIT-IORT was not noninferior to EBRT. The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%). With long-term follow-up (median [IQR], 9.0 [7.5-10.5] years), there was no statistically significant difference in local recurrence-free survival (HR, 0.75; 95% CI, 0.57-1.003; P = .052), mastectomy-free survival (HR, 0.88; 95% CI, 0.65-1.18; P = .38), distant disease-free survival (HR, 1.00; 95% CI, 0.72-1.39; P = .98), or overall survival (HR, 0.96; 95% CI, 0.68-1.35; P = .80).
Conclusions and Relevance


These long-term data show that despite an increase in the number of local recurrences with delayed TARGIT-IORT, there was no statistically significant decrease in mastectomy-free survival, distant disease-free survival, or overall survival.
Trial Registration


ISRCTN34086741, ClinicalTrials.gov Identifier: NCT00983684.",2020,"The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%).","['1153 patients aged 45 years or older with invasive ductal breast carcinoma smaller than 3.5 cm treated with breast conservation', 'Sixty patients (5%) had tumors larger than 2 cm, or had positive nodes and only 32 (2.7%) were younger than 50 years', 'Early Breast Cancer', '581 women (mean [SD] age, 63 [7] years', 'and 572 patients (mean [SD] age, 63 [8] years', '2004; patients who had their cancer excised']","['EBRT', 'radiotherapy', 'delayed TARGIT-IORT', 'Conventional adjuvant radiotherapy', 'EBRT or delayed TARGIT-IORT given as a second procedure by reopening the lumpectomy wound', 'delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT', 'Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy', 'needle biopsy to receive TARGIT-IORT', 'breast external beam radiotherapy (EBRT']","['mastectomy-free survival', 'Local Recurrence and Survival', 'distant disease-free survival', 'mastectomy-free survival, distant disease-free survival, or overall survival', 'local recurrence rates', 'local recurrence rate', 'number of local recurrences', 'local recurrence-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0005560', 'cui_str': 'Needle biopsy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",1153.0,0.381474,"The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%).","[{'ForeName': 'Jayant S', 'Initials': 'JS', 'LastName': 'Vaidya', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'University of Western Australia School of Surgery, West Australia, Australia.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Flyger', 'Affiliation': 'Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Tobias', 'Affiliation': 'Department of Clinical Oncology, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Corica', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, West Australia, Australia.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Massarut', 'Affiliation': 'Department of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'University Medical Center Mannheim, Department of Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Pigorsch', 'Affiliation': 'Red Cross Hospital, Department of Gynecology and Obstetrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarado', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Douek', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Red Cross Hospital, Department of Gynecology and Obstetrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Potyka', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Patient Advocate and Writer, London, United Kingdom.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sperk', 'Affiliation': 'University Medical Center Mannheim, Department of Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Laws', 'Affiliation': 'Department of Surgery, Royal Hampshire County Hospital, Winchester, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sütterlin', 'Affiliation': 'University Medical Center Mannheim, Department of Gynecology and Obstetrics, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': ""Department of Oncology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'Helen Rey Breast Cancer Foundation, John Wayne Cancer Institute, University of Southern California, Los Angeles.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Vinante', 'Affiliation': 'Department of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bozza', 'Affiliation': 'Instituto Oncologico Veneto, Padoa, Italy.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Pazos', 'Affiliation': 'University Hospital, Department of Radiation Oncology, Ludwig Maximilians Universitat, Munich, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Le Blanc-Onfroy', 'Affiliation': ""Oncologue radiothérapeute, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Brust Zentrum Seefeld, Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Polkowski', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': 'Breast Center, Universitätsspital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Niewald', 'Affiliation': 'Saarland University Medical Center, Homberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blohmer', 'Affiliation': 'Sankt Gertrauden-Krankenhaus, and The Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCready', 'Affiliation': 'Princess Margaret Cancer Centre Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hoefer', 'Affiliation': 'Sentara Surgery Specialists, Hampton, Virginia.'}, {'ForeName': 'Pond', 'Initials': 'P', 'LastName': 'Kelemen', 'Affiliation': 'Ashikari Breast Center, New York Medical College, New York, New York.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Petralia', 'Affiliation': 'Department of Surgery, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Department of Pathology, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baum', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, West Australia, Australia.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0249']
351,32239291,Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial.,"This post hoc Poisson regression analysis investigated the relationship between mean volume voided and incontinence episodes/24 h after fixed frequency adjustment in children with overactive bladder from the LION study, a phase 3, double-blind, randomised, placebo-controlled, sequential, dose-titration solifenacin trial. Patients were aged 5-< 12 years with ≥ 4 episodes of daytime incontinence during a 7-day pre-baseline diary period. The dependent variable was the mean number of incontinence episodes/24 h at the end of study. Explanatory variables included treatment, mean number of incontinence episodes/24 h at baseline, and change from baseline to end of study in mean volume voided. Statistical significance and goodness of fit were analysed using the Pearson's chi-square test. A negative estimate was found between the dependent variable 'incontinence' and both mean volume voided and daytime maximum volume voided/micturition (an increase in mean volume voided or daytime maximum volume voided/micturition would lead to a reduction in incontinence; P = 0.0014 and P = 0.0317, respectively). The model was a good fit to the data in both analyses with a Pearson's chi-square goodness-of-fit criteria of 0.8.Conclusion: Increase in mean volume voided was significantly correlated to reduction in incontinence episodes/24 h in children with overactive bladder treated with solifenacin.This study is registered at ClinicalTrials.gov : NCT01565707. What is known: • Mean volume voided per micturition is used as an indicator of treatment efficacy, with increases noted as number of incontinence episodes (and micturition frequency) decrease. • The relationship between mean volume voided and incontinence episodes is not clearly understood. What is new: • Increase in mean volume voided significantly correlated to reduction in incontinence in solifenacin-treated children with overactive bladder (Poisson regression model analysis). • Compared with placebo, solifenacin-treated children had a lower predicted number of incontinence episodes/24 h.",2020,"A negative estimate was found between the dependent variable 'incontinence' and both mean volume voided and daytime maximum volume voided/micturition (an increase in mean volume voided or daytime maximum volume voided/micturition would lead to a reduction in incontinence; P = 0.0014 and P = 0.0317, respectively).","['children with overactive bladder treated with', 'children with overactive bladder', 'Patients were aged']","['placebo, solifenacin', 'placebo', 'solifenacin']","['mean volume voided and daytime maximum volume voided/micturition', 'number of incontinence episodes/24\xa0h', 'mean number of incontinence episodes/24\xa0h at baseline, and change from baseline to end of study in mean volume voided', 'daytime incontinence', 'mean number of incontinence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",,0.0452337,"A negative estimate was found between the dependent variable 'incontinence' and both mean volume voided and daytime maximum volume voided/micturition (an increase in mean volume voided or daytime maximum volume voided/micturition would lead to a reduction in incontinence; P = 0.0014 and P = 0.0317, respectively).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Snijder', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, Netherlands. Robert.Snijder@astellas.com.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Bosman', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Stroosma', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, Netherlands.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Agema', 'Affiliation': 'Astellas Pharma Europe B.V., Leiden, Netherlands.'}]",European journal of pediatrics,['10.1007/s00431-020-03635-2']
352,31938829,Heterogeneity of treatment effect of prophylactic pantoprazole in adult ICU patients: a post hoc analysis of the SUP-ICU trial.,"PURPOSE


The Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) trial compared prophylactic pantoprazole with placebo in 3291 adult ICU patients at risk of clinically important gastrointestinal bleeding (CIB). As a predefined subgroup analysis suggested increased 90-day mortality with pantoprazole in the most severely ill patients, we aimed to further explore whether heterogenous treatment effects (HTE) were present.
METHODS


We assessed HTE in subgroups defined according to illness severity by SAPS II quintiles and the total number of risk factors for CIB using Bayesian hierarchical models, and on the continuous scale using Bayesian logistic regression models with interactions. Estimates were presented as posterior probability distributions of odds ratios (ORs), probabilities of different effect sizes, and marginal effects plots.
RESULTS


We observed potential HTE for 90-day mortality according to illness severity (median subgroup OR range 0.90-1.09) with higher risk in the most severely ill, but not with different numbers of risk factors (1.00-1.02). We observed potential HTE of pantoprazole for clinically important events (0.86-1.18) and infectious adverse events (0.88-1.27) with higher risk in patients with greater illness severity and in those with more risk factors for CIB. Pantoprazole substantially and consistently reduced the risk of CIB with no indications of HTE (0.53-0.63).
CONCLUSIONS


In this post hoc analysis of the SUP-ICU trial, we found indications of HTE with increased risks of serious adverse events in patients with greater illness severity or more risk factors for CIB allocated to pantoprazole. These findings are hypothesis-generating and warrant further prospective investigation. CLINICALTRIALS.
GOV IDENTIFIER


NCT02467621.",2020,"Pantoprazole substantially and consistently reduced the risk of CIB with no indications of HTE (0.53-0.63).
","['adult ICU patients', '3291 adult ICU patients at risk of clinically important gastrointestinal bleeding (CIB']","['prophylactic pantoprazole', 'Pantoprazole', 'pantoprazole', 'prophylactic pantoprazole with placebo']","['90-day mortality', 'posterior probability distributions of odds ratios (ORs), probabilities of different effect sizes, and marginal effects plots', 'risk of CIB', 'infectious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3291.0,0.126774,"Pantoprazole substantially and consistently reduced the risk of CIB with no indications of HTE (0.53-0.63).
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. andersgran@gmail.com.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Marker', 'Affiliation': 'Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Krag', 'Affiliation': 'Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Research Institute, HCor-Hospital do Coração, São Paulo, Brazil.'}, {'ForeName': 'Hans-Christian', 'Initials': 'HC', 'LastName': 'Thorsen-Meyer', 'Affiliation': 'Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Benjamin Skov', 'Initials': 'BS', 'LastName': 'Kaas-Hansen', 'Affiliation': 'NNF Center for Protein Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'Department of Intensive Care, Maastricht University Medical Center+, University Maastricht, Maastricht, The Netherlands.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Centre for Research in Intensive Care, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Centre for Research in Intensive Care, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care 4131, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}]",Intensive care medicine,['10.1007/s00134-019-05903-8']
353,32229229,Effectiveness and Safety of Supervised Home-Based Physical Training in Patients With COPD on Long-term Home Oxygen Therapy: A Randomized Trial.,"BACKGROUND


Patients with COPD in advanced stages who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs. This difficulty is due to the severity of their disease, limitations involving transportation and mobility, high costs, and issues related to patients' safety and individual needs. Unsupervised home-based physical training (PT) is frequently used.
RESEARCH QUESTION


The main objective of this study was to investigate the effectiveness of a supervised home-based PT program on exercise capacity and other outcomes in patients with COPD receiving LTHOT.
STUDY DESIGN AND METHODS


In a randomized clinical trial, patients with COPD who were on LTHOT were allocated into two groups: the supervised physical training (PT) group, consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-min sessions for 12 weeks; and the unsupervised activity booklet group, consisting of patients who received a booklet advising them to perform exercise twice a week for 12 weeks. All participants were assessed prior to and following the intervention in terms of exercise capacity (6-min step-test and the 1-min sit-to-stand test); dyspnea (Medical Research Council scale); fatigue (Brazilian Portuguese version of the Fatigue Severity Scale); and health status (COPD Assessment Test).
RESULTS


A total of 44 patients were assessed (mean age, 70 ± 8 years; FEV 1 , 33 ± 14% predicted) (PT group, n = 22; booklet group, n = 22). Only the PT group patients presented significant improvement in the 6-min step-test (21 ± 9 vs 14 ± 11; P = .001), Medical Research Council scale (3.3 ± 1.0 vs 3.9 ± 0.9; P = .013), Brazilian Portuguese version of the Fatigue Severity Scale (5.0 ± 1.4 vs 5.2 ± 1.3; P = .015), and COPD Assessment Test (21 ± 8 vs 26 ± 6; P = .001). No adverse effects were observed.
INTERPRETATION


Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue, and health status in patients with COPD on LTHOT.
CLINICAL TRIAL REGISTRATION


Brazilian Registry of Clinical Trials; No.: RBR-535smn; URL: http://www.ensaiosclinicos.gov.br.",2020,"Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue and health status in patients with COPD on LTHOT.","['44 patients were assessed (70±8 years, FEV 1 : 33±14%predicted) (PTG, n=22; BG, n=22', 'patients with COPD', 'patients with COPD on LTHOT', 'Patients with chronic obstructive pulmonary disease (COPD) in advanced disease stage who need long-term home oxygen therapy (LTHOT) have difficulty participating in outpatient pulmonary rehabilitation (PR) programs']","['supervised home-based PT program', 'THERAPY', 'supervised physical training group (PTG), consisting of patients who received home-based supervised muscle strength and endurance training in twice-weekly 60-minute sessions for 12 weeks; and unsupervised activity booklet group (BG), consisting of patients who received a booklet advising them to perform exercise', 'Unsupervised home-based physical training (PT']","['exercise capacity (6-Minute Step-Test (6MST) and the 1-Minute Sit-to-Stand Test [STST]); dyspnea (Medical Research Council scale [MRC]); fatigue (Fatigue Severity Scale [FSS-BR]); and health status (COPD Assessment Test [CAT', 'FSS-BR', 'adverse effects', 'MRC', 'exercise capacity, dyspnea, fatigue and health status', '6MST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy (procedure)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",44.0,0.0462586,"Supervised home-based PT was effective and safe in improving exercise capacity, dyspnea, fatigue and health status in patients with COPD on LTHOT.","[{'ForeName': 'Demetria', 'Initials': 'D', 'LastName': 'Kovelis', 'Affiliation': 'Department of Physical Therapy, UniDomBosco University, Curitiba, Paraná, Brazil. Electronic address: demetriakovelis@gmail.com.'}, {'ForeName': 'Anna R S', 'Initials': 'ARS', 'LastName': 'Gomes', 'Affiliation': 'Department of Prevention and Rehabilitation in Physical Therapy, Masters/Doctoral Program in Physical Education, Federal University of Paraná, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Mazzarin', 'Affiliation': 'Cajuru University Hospital, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Samia K', 'Initials': 'SK', 'LastName': 'Biazim', 'Affiliation': 'Cajuru University Hospital, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pitta', 'Affiliation': 'Department of Physical Therapy, State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Valderramas', 'Affiliation': 'Department of Prevention and Rehabilitation in Physical Therapy, Masters/Doctoral Program in Internal Medicine and Health Sciences, Federal University of Paraná, Curitiba, Paraná, Brazil.'}]",Chest,['10.1016/j.chest.2020.02.063']
354,32053556,Effect of Apraclonidine and Diclofenac on Early Changes in Intraocular Pressure After Selective Laser Trabeculoplasty.,"PRéCIS:: Adjuvant diclofenac and apraclonidine eye drop given in conjunction with selective laser trabeculoplasty (SLT) do not significantly impact medium-term intraocular pressure (IOP) reduction compared with placebo, but apraclonidine can be used to blunt immediate postlaser pressure spikes.
PURPOSE


There is limited high-grade evidence guiding the choice of eye drops given before and after SLT. The authors chose to measure IOP during the first 24 hours, at 1 week, 6 weeks, and 6 months after SLT, and compare the effect of apraclonidine before SLT and diclofenac after SLT, with placebo.
MATERIALS AND METHODS


In this double-blind, randomized, placebo-controlled trial, patients with open-angle glaucoma or ocular hypertension referred for SLT were recruited between 2016 and 2018. Patients were randomized to receive either apraclonidine pre-SLT with placebo post-SLT, placebo pre-SLT with diclofenac post-SLT, or placebo before and after SLT.
RESULTS


Sixty eyes from 35 patients were treated with 360-degree SLT. Twenty-four-hour IOP measurements with patient self-monitoring after SLT demonstrated a moderate IOP spike at 1 hour and 2 hours post-SLT in the placebo and diclofenac study arms (mean=+4.05±0.58 mm Hg and +4.47±0.73, respectively, P<0.001 vs. pre-SLT IOP), which was prevented by apraclonidine (mean=-2.41±0.88 mm Hg, P<0.0001 vs. other study arms post-SLT). There were no significant differences between the 3 arms of the study on the long-term IOP reduction achieved by SLT (6 wk: P=0.51, 6 mo: P=0.42).
CONCLUSIONS


Neither the use of apraclonidine before SLT nor diclofenac after SLT significantly influenced the IOP reduction induced by SLT. Except for a slight and transient reduction in intraocular inflammation, there was no beneficial effect of diclofenac on early IOP changes or the degree of patient discomfort relative to placebo.",2020,"There were no significant differences between the three arms of the study on the long-term IOP reduction achieved by SLT (6▒wk: P=0.51, 6▒mo: P=0.42).
",['patients with open-angle glaucoma or ocular hypertension referred for SLT were recruited between 2016-2018'],"['apraclonidine before SLT and diclofenac', 'apraclonidine pre-SLT with placebo post-SLT, placebo pre-SLT with diclofenac post-SLT, or placebo', 'Apraclonidine and Diclofenac', 'diclofenac and apraclonidine', 'placebo', 'apraclonidine', 'selective laser trabeculoplasty (SLT', '360-degree SLT', 'diclofenac', 'Selective Laser Trabeculoplasty']","['intraocular inflammation', 'Intraocular Pressure', 'long-term IOP reduction', 'intraocular pressure (IOP', 'moderate IOP spike', 'IOP reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017612', 'cui_str': 'Glaucoma, Compensated'}, {'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}]","[{'cui': 'C0048038', 'cui_str': 'apraclonidine'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",35.0,0.437049,"There were no significant differences between the three arms of the study on the long-term IOP reduction achieved by SLT (6▒wk: P=0.51, 6▒mo: P=0.42).
","[{'ForeName': 'Vinita Rangroo', 'Initials': 'VR', 'LastName': 'Thrane', 'Affiliation': 'Department of Ophthalmology, Haukeland University Hospital.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Thrane', 'Affiliation': 'Department of Ophthalmology, Haukeland University Hospital.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Bergo', 'Affiliation': 'Department of Clinical Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Hildegunn', 'Initials': 'H', 'LastName': 'Halvorsen', 'Affiliation': 'Department of Ophthalmology, Haukeland University Hospital.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Krohn', 'Affiliation': 'Department of Ophthalmology, Haukeland University Hospital.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001457']
355,31256717,Association of Total Medication Burden With Intensive and Standard Blood Pressure Control and Clinical Outcomes: A Secondary Analysis of SPRINT.,"Total medication burden (antihypertensive and nonantihypertensive medications) may be associated with poor systolic blood pressure (SBP) control. We investigated the association of baseline medication burden and clinical outcomes and whether the effect of the SBP intervention varied according to baseline medication burden in SPRINT (Systolic Blood Pressure Intervention Trial). Participants were randomized to intensive or standard SBP goal (below 120 or 140 mm Hg, respectively); n=3769 participants with high baseline medication burden (≥5 medications) and n=5592 with low burden (<5 medications). Primary outcome: differences in SBP. Secondary outcomes: 8-item Morisky Medication Adherence Scale and modified Treatment Satisfaction Questionnaire for Medications measured at baseline and 12 months and incident cardiovascular disease events and serious adverse events throughout the trial. Participants in the intensive group with high versus low medication burden were less likely to achieve their SBP goal at 12 months (risk ratio, 0.91; 95% CI, 0.85-0.97) but not in the standard group (risk ratio, 0.98; 95% CI, 0.93-1.03; P interaction <0.001). High medication burden was associated with increased cardiovascular disease events (hazard ratio, 1.39; 95% CI, 1.14-1.70) and serious adverse events (hazard ratio, 1.34; 95% CI, 1.24-1.45), but the effect of intensive versus standard treatment did not vary between medication burden groups ( P interaction >0.5). Medication burden had minimal association with adherence or satisfaction. High baseline medication burden was associated with worse intensive SBP control and higher rates of cardiovascular disease events and serious adverse events. The relative benefits and risks of intensive SBP goals were similar regardless of medication burden. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01206062.",2019,"High medication burden was associated with increased cardiovascular disease events (hazard ratio, 1.39; 95% CI, 1.14-1.70) and serious adverse events (hazard ratio, 1.34; 95% CI, 1.24-1.45), but the effect of intensive versus standard treatment did not vary between medication burden groups ( P interaction >0.5).","['goal (below 120 or 140 mm Hg, respectively); n=3769 participants with high baseline medication burden (≥5 medications) and n=5592 with low burden (<5 medications']","['Intensive and Standard Blood Pressure Control and Clinical Outcomes', 'intensive or standard SBP', 'SBP intervention']","['Total medication burden (antihypertensive and nonantihypertensive medications', 'cardiovascular disease events', 'systolic blood pressure (SBP) control', 'SBP', '8-item Morisky Medication Adherence Scale and modified Treatment Satisfaction Questionnaire for Medications measured at baseline and 12 months and incident cardiovascular disease events and serious adverse events', 'SBP goal', 'cardiovascular disease events and serious adverse events', 'serious adverse events', 'Total Medication Burden']","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",3769.0,0.218971,"High medication burden was associated with increased cardiovascular disease events (hazard ratio, 1.39; 95% CI, 1.14-1.70) and serious adverse events (hazard ratio, 1.34; 95% CI, 1.24-1.45), but the effect of intensive versus standard treatment did not vary between medication burden groups ( P interaction >0.5).","[{'ForeName': 'Catherine G', 'Initials': 'CG', 'LastName': 'Derington', 'Affiliation': 'From Kaiser Permanente Colorado, Aurora (C.G.D., J.B.K.).'}, {'ForeName': 'Tyler H', 'Initials': 'TH', 'LastName': 'Gums', 'Affiliation': 'University of Texas at Austin, Austin, TX (T.H.G.).'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT (A.P.B., J.S.H., T.H.G., J.B.K.).'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Herrick', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT (A.P.B., J.S.H., T.H.G., J.B.K.).'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'Greene', 'Affiliation': 'University of Utah, School of Medicine, Salt Lake City, UT (A.P.B., J.S.H., T.H.G., J.B.K.).'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Columbia University Medical Center, New York, NY (A.E.M., I.M.K.).'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC (W.S.W.).'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Columbia University Medical Center, New York, NY (A.E.M., I.M.K.).'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Morisky', 'Affiliation': 'Fielding School of Public Health, University of California Los Angeles, CA (D.E.M.).'}, {'ForeName': 'Katy E', 'Initials': 'KE', 'LastName': 'Trinkley', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO (C.G.D., K.E.T., J.J.S.).'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Saseen', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO (C.G.D., K.E.T., J.J.S.).'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Reynolds', 'Affiliation': 'Kaiser Permanente Southern California, Pasadena, CA (K.R.).'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX (J.T.B.).'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Boston University School of Public Health, MA (D.R.B.).'}, {'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'Stanford University School of Medicine, CA (T.I.C.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'School of Medicine, University of Colorado, Aurora, CO (K.E.T., J.J.S., M.C.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': ""Memphis Veteran's Affairs Medical Center, Memphis, TN (W.C.C.).""}, {'ForeName': 'Capri G', 'Initials': 'CG', 'LastName': 'Foy', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC (C.G.F., N.M.P.).'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Herring', 'Affiliation': 'Campbell University College of Pharmacy and Health Sciences, Buies Creek, NC (C.T.H.).'}, {'ForeName': 'Lois Anne', 'Initials': 'LA', 'LastName': 'Katz', 'Affiliation': 'New York University Langone School of Medicine, New York, NY (L.A.K.).'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Tulane University School of Medicine and Public Health and Tropical Medicine, New Orleans, LA (M.K.-W.).'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC (C.G.F., N.M.P.).'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Tamariz', 'Affiliation': 'School of Medicine, University of Miami, FL (L.T.).'}, {'ForeName': 'Jordan B', 'Initials': 'JB', 'LastName': 'King', 'Affiliation': 'From Kaiser Permanente Colorado, Aurora (C.G.D., J.B.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.12907']
356,32166864,Effect of Rifampin-Mediated OATP1B1 and OATP1B3 Transporter Inhibition on the Pharmacokinetics of the P2Y12 Receptor Antagonist Selatogrel.,"In vitro studies have indicated that the P2Y12 receptor antagonist selatogrel is a substrate of organic anion-transporting-polypeptide (OATP)1B1 and OATP1B3 that are known to mediate hepatic uptake. Selatogrel is primarily eliminated via the biliary route. Therefore, the study aim was to investigate the effect of rifampin-mediated OATP1B1 and OATP1B3 inhibition on the pharmacokinetics (PK) of selatogrel. This was a randomized, double-blind, placebo-controlled, two-period, crossover study in 14 healthy subjects. In each period, a single subcutaneous dose of 4 mg selatogrel was administered, either immediately after a single intravenous 30 minutes infusion of 600 mg rifampin or after placebo. Plasma samples were collected for 36 hours and analyzed using a validated liquid chromatography-tandem mass spectrometry method. PK parameters of selatogrel were calculated using noncompartmental analysis. The effect of rifampin was explored based on geometric mean peak plasma concentration (C max  ) and area under the concentration curve from zero to infinity (AUC 0-∞  ) ratios and for time of maximum plasma concentration (T max  ) by Wilcoxon signed rank test. In addition, the safety and tolerability of the study treatments were evaluated. The geometric mean ratios of C max  and AUC 0-∞  were 1.19 (90% confidence interval (CI) 1.11-1.28) and 1.43 (90% CI 1.36-1.51), respectively, indicating a minor selatogrel exposure increase when administered after an infusion of rifampin compared with placebo. Rifampin administration did not affect terminal half-life (t ½  ) or T max  of selatogrel. All study treatments were safe and well-tolerated. A single dose of 600 mg rifampin, a potent OATP1B1/1B3 inhibitor, did not impact the PK of selatogrel to a clinically relevant extent suggesting that OATP1B1 and OATP1B3 transporters do not play a major role in the elimination of selatogrel.",2020,Rifampin administration did not affect t ½  or t max  of selatogrel.,['14 healthy subjects'],"['rifampin or after placebo', 'placebo', 'rifampin-mediated OATP1B1 and OATP1B3 inhibition', 'rifampin', 'rifampin-mediated OATP1B1 and OATP1B3 transporter inhibition', 'Rifampin']","['safety and tolerability', 'PK parameters of selatogrel', 't ½  or t max  of selatogrel', 'geometric mean C max  and AUC 0-∞  ratios and for t max  by Wilcoxon signed rank test', 'geometric mean ratios of C max  and AUC 0-∞', 'safe and well tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",14.0,0.41011,Rifampin administration did not affect t ½  or t max  of selatogrel.,"[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Schilling', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Voors-Pette', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Romeijn', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dogterom', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12774']
357,30499157,Pharmacokinetics and pharmacodynamics of dapagliflozin in combination with insulin in Japanese patients with type 1 diabetes.,"AIMS


To assess the pharmacokinetics/pharmacodynamics (PK/PD) of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor that increases urinary glucose excretion (UGE) and its major metabolite, dapagliflozin-3-O-glucuronide (D3OG), in Japanese patients with type 1 diabetes (T1D) and inadequate glycaemic control (HbA1c 7%-10%).
MATERIALS AND METHODS


Japanese patients (18-65 years) with inadequately controlled T1D were randomized 1:1:1 to dapagliflozin 5 mg, 10 mg or placebo (n = 14 each) once daily for 7 days, with adjustable insulin. The PK/PD characteristics of dapagliflozin and D3OG were assessed on Day 7. Patients underwent follow-up evaluation on Days 8 and 14. Adverse events (AEs), hypoglycaemic episodes and events of diabetic ketoacidosis (DKA) were recorded over the treatment and follow-up periods.
RESULTS


A total of 42 randomized patients received dapagliflozin or placebo. PK variables increased in a dose-dependent manner. D3OG was generated rapidly, with a median time to maximum plasma concentration of 2.0 hours (1.0-3.0). The dapagliflozin dose-UGE relationship was attenuated, with larger insulin dose reductions than anticipated. Mean percent (standard error) changes in total daily insulin dose from baseline to Day 7 were - 36.86% (3.32), -39.13% (2.68) and - 4.97% (5.28) for dapagliflozin 5 mg and 10 mg and for placebo, respectively. No DKA was reported. AEs were consistent with the established dapagliflozin safety profile. There was no increase in hypoglycaemia.
CONCLUSIONS


The PK and safety profiles of dapagliflozin in Japanese patients with T1D were consistent with previous studies, but with an unanticipated attenuation of the PD dose-response measured as UGE.",2019,"Mean percent (standard error) changes in total daily insulin dose from baseline to Day 7 were - 36.86% (3.32), -39.13% (2.68) and - 4.97% (5.28) for dapagliflozin 5 mg and 10 mg and for placebo, respectively.","['Japanese patients (18-65\u2009years) with inadequately controlled T1D', 'Japanese patients with T1D', 'Japanese patients with type 1 diabetes', 'Japanese patients with type 1 diabetes (T1D) and inadequate glycaemic control (HbA1c 7%-10']","['placebo', 'dapagliflozin, a sodium-glucose co-transporter 2 inhibitor', 'dapagliflozin or placebo', 'dapagliflozin 5 mg, 10 mg or placebo', 'dapagliflozin']","['PK variables', 'hypoglycaemia', 'Mean percent (standard error) changes in total daily insulin dose', 'Adverse events (AEs), hypoglycaemic episodes and events of diabetic ketoacidosis (DKA', 'urinary glucose excretion (UGE) and its major metabolite, dapagliflozin-3-O-glucuronide (D3OG']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3709923', 'cui_str': 'dapagliflozin 5 MG'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]",42.0,0.167614,"Mean percent (standard error) changes in total daily insulin dose from baseline to Day 7 were - 36.86% (3.32), -39.13% (2.68) and - 4.97% (5.28) for dapagliflozin 5 mg and 10 mg and for placebo, respectively.","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'SOUSEIKAI Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Ueda', 'Affiliation': 'AstraZeneca, Osaka, Japan.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Asano', 'Affiliation': 'AstraZeneca, Osaka, Japan.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thorén', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Hyosung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'AstraZeneca, Osaka, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Yajima', 'Affiliation': 'AstraZeneca, Osaka, Japan.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': 'Department of Metabolic Medicine, Kumamoto University, Kumamoto, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13593']
358,30499237,Sustained 52-week efficacy and safety of triple therapy with dapagliflozin plus saxagliptin versus dual therapy with sitagliptin added to metformin in patients with uncontrolled type 2 diabetes.,"AIMS


To compare the efficacy and safety of an intensification strategy of early triple combination therapy with dapagliflozin (DAPA) plus saxagliptin (SAXA) to a dual therapy strategy with sitagliptin (SITA) in patients with type 2 diabetes who are inadequately controlled with metformin (MET) monotherapy.
MATERIALS AND METHODS


This multinational, active-controlled, parallel-group phase 3b trial randomized 461 patients, at least 18 years of age, with glycated haemoglobin (HbA1c) of 8%-10.5% (64-91 mmol/mol), to either DAPA plus SAXA or SITA, added to MET, for a 26-week double-blind treatment period and an extension of a 26-week blinded treatment period.
RESULTS


Mean (± SD) baseline HbA1c was 8.8% ± 0.9% (73.0 ± 9.3 mmol/mol). DAPA plus SAXA (n = 232) provided a greater reduction from baseline in HbA1c at Weeks 26 and 52 compared with SITA (n = 229) (adjusted mean ± SE change, Week 26: -1.41 ± 0.07% vs -1.07 ± 0.07% [-15.4 ± 0.8 mmol/mol vs 11.7 ± 0.8 mmol/mol]; P = 0.0008; Week 52: -1.29 ± 0.08% vs -0.81 ± 0.09% [14.1 ± 0.9 mmol/mol vs 8.9 ± 1.0 mmol/mol]). The between-group difference in adjusted mean (95% CI) change from baseline in HbA1c increased from -0.34 (-0.54, -0.14) at Week 26 to -0.48 (-0.71, -0.25) at Week 52. DAPA plus SAXA was generally well tolerated and the incidence of adverse events was similar in both treatment arms.
CONCLUSIONS


Early intensification to triple therapy with DAPA plus SAXA results in better, more durable glycaemic control than addition of SITA only (dual therapy) in patients with high HbA1c levels who are uncontrolled with MET monotherapy.",2019,"DAPA plus SAXA (n = 232) provided a greater reduction from baseline in HbA1c at Weeks 26 and 52 compared with SITA (n = 229) (adjusted mean ± SE change, Week 26: -1.41 ± 0.07% vs -1.07 ± 0.07% [-15.4 ± 0.8 mmol/mol vs 11.7 ± 0.8 mmol/mol]; P = 0.0008; Week 52: -1.29 ± 0.08% vs -0.81 ± 0.09% [14.1 ± 0.9 mmol/mol vs 8.9 ± 1.0 mmol/mol]).","['461 patients, at least 18\u2009years of age, with glycated haemoglobin (HbA1c) of 8%-10.5% (64-91\u2009mmol/mol), to either', 'patients with type 2 diabetes who are inadequately controlled with metformin (MET) monotherapy', 'patients with high HbA1c levels who are uncontrolled with MET monotherapy', 'patients with uncontrolled type 2 diabetes']","['dapagliflozin (DAPA) plus saxagliptin (SAXA', 'sitagliptin (SITA', 'dapagliflozin plus saxagliptin', 'DAPA plus SAXA or SITA', 'DAPA plus SAXA', 'sitagliptin added to metformin']","['tolerated and the incidence of adverse events', 'HbA1c', 'Mean (± SD) baseline HbA1c', 'durable glycaemic control', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",461.0,0.137644,"DAPA plus SAXA (n = 232) provided a greater reduction from baseline in HbA1c at Weeks 26 and 52 compared with SITA (n = 229) (adjusted mean ± SE change, Week 26: -1.41 ± 0.07% vs -1.07 ± 0.07% [-15.4 ± 0.8 mmol/mol vs 11.7 ± 0.8 mmol/mol]; P = 0.0008; Week 52: -1.29 ± 0.08% vs -0.81 ± 0.09% [14.1 ± 0.9 mmol/mol vs 8.9 ± 1.0 mmol/mol]).","[{'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Handelsman', 'Affiliation': 'Metabolic Institute of America, Tarzana, California.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Raisa', 'Initials': 'R', 'LastName': 'Kurlyandskaya', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13594']
359,32227244,Isradipine Versus Placebo in Early Parkinson Disease.,,2020,,['Early Parkinson Disease'],['Isradipine Versus Placebo'],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0516642,,[],Annals of internal medicine,['10.7326/P20-0004']
360,32227247,Isradipine Versus Placebo in Early Parkinson Disease: A Randomized Trial.,"Background


Studies suggest that dihydropyridine calcium-channel blockers may be associated with reduced risk for Parkinson disease (PD).
Objective


To assess the effect of isradipine, a dihydropyridine calcium-channel blocker, on the rate of clinical progression of PD.
Design


Multicenter, randomized, parallel-group, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT02168842).
Setting


57 Parkinson Study Group sites in North America.
Participants


Patients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment.
Intervention


5 mg of immediate-release isradipine twice daily or placebo for 36 months.
Measurements


The primary outcome was change in the Unified Parkinson's Disease Rating Scale (UPDRS) parts I to III score measured in the antiparkinson medication ""ON"" state between baseline and 36 months. Secondary outcomes included time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures.
Results


336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study. Adjusted least-squares mean changes in total UPDRS score in the antiparkinson medication ON state over 36 months for isradipine and placebo recipients were 2.99 (95% CI, 0.95 to 5.03) points versus 3.26 (CI, 1.25 to 5.26) points, respectively, with a treatment effect of -0.27 (CI, -3.02 to 2.48) point (P = 0.85). Statistical adjustment for antiparkinson medication use did not change the findings. Secondary outcomes showed no effect of isradipine treatment. The most common adverse effects of isradipine were edema and dizziness.
Limitation


The isradipine dose may have been insufficient to engage the target calcium channels associated with neuroprotective effects.
Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
Primary Funding Source


National Institute of Neurological Disorders and Stroke.",2020,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","['336 patients were randomly assigned (mean age, 62 years [SD, 9]; 68% men; disease duration, 0.9 year [SD, 0.7]; mean UPDRS part I to III score, 23.1 [SD, 8.6]); 95% of patients completed the study', 'Participants\n\n\nPatients with early-stage PD (duration <3 years) who were not taking dopaminergic medications at enrollment', 'Setting\n\n\n57 Parkinson Study Group sites in North America', 'Early Parkinson Disease']","['dihydropyridine calcium-channel blocker', 'placebo', 'dihydropyridine calcium-channel blockers', 'isradipine', 'Intervention\n\n\n5 mg of immediate-release isradipine twice daily or placebo', 'Isradipine Versus Placebo']","[""Unified Parkinson's Disease Rating Scale (UPDRS) parts"", 'time to initiation and use of antiparkinson medications, time to onset of motor complications, change in nonmotor disability, and quality-of-life measures', 'total UPDRS score', 'edema and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}, {'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",336.0,0.515182,"Conclusion


Long-term treatment with immediate-release isradipine did not slow the clinical progression of early-stage PD.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2534']
361,32102629,Redefined Measure of Early Neurological Improvement Shows Treatment Benefit of Alteplase Over Placebo.,"Background and Purpose- The first of the 2 NINDS (National Institute of Neurological Disorders and Stroke) Study trials did not show a significant increase in early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) improvement by ≥4, with alteplase treatment. We hypothesized that early neurological improvement defined as a percentage change in NIHSS (percent change NIHSS) at 24 hours is superior to other definitions in predicting 3-month functional outcomes and using this definition there would be treatment benefit of alteplase over placebo at 24 hours. Methods- We analyzed the NINDS rt-PA Stroke Study (Parts 1 and 2) trial data. Percent change NIHSS was defined as ([admission NIHSS score-24-hour NIHSS score]×100/admission NIHSS score] and delta NIHSS as (admission NIHSS score-24-hour NIHSS score). We compared early neurological improvement using these definitions between alteplase versus placebo patients. We also used receiver operating characteristic curve to determine the predictive association of early neurological improvement with excellent 3-month functional outcomes (Barthel Index score of 95-100 and modified Rankin Scale score of 0-1), good 3-month functional outcome (modified Rankin Scale score of 0-2), and 3-month infarct volume. Results- There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471). Receiver operating characteristic curve comparison showed that percent change NIHSS (ROC percent ) was better than delta NIHSS (ROC delta ) and admission NIHSS (ROC admission ) with regards to excellent 3-month Barthel Index (ROC percent , 0.83; ROC delta , 0.76; ROC admission , 0.75), excellent 3-month modified Rankin Scale (ROC percent , 0.83; ROC delta , 0.74; ROC admission , 0.78), and good 3-month modified Rankin Scale (ROC percent , 0.83; ROC delta , 0.76; ROC admission , 0.78). Conclusions- In the NINDS rt-PA trial, alteplase was associated with a significant percent change improvement in NIHSS at 24 hours. Percent change in NIHSS may be a better surrogate marker of thrombolytic activity and 3-month outcomes.",2020,There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471).,[],"['placebo', 'Methods', ' and Purpose', 'Placebo', 'Conclusions']","['functional outcomes (Barthel Index score of 95-100 and modified Rankin Scale score of 0-1), good 3-month functional outcome (modified Rankin Scale score of 0-2), and 3-month infarct volume', '24-hour median percent change NIHSS', 'early neurological improvement, defined as National Institutes of Health Stroke Scale (NIHSS) improvement', 'excellent 3-month modified Rankin Scale', 'delta NIHSS (ROC delta ) and admission NIHSS (ROC admission ', 'good 3-month modified Rankin Scale']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.0713408,There was a significantly greater improvement in the 24-hour median percent change NIHSS among patients treated with alteplase compared with the placebo group (28% versus 15%;  P =0.045) but not median delta NIHSS (3 versus 2;  P =0.471).,"[{'ForeName': 'Shashank', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Scher', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lord', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frontera', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Koto', 'Initials': 'K', 'LastName': 'Ishida', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Torres', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Rostanski', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Mistry', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN (E.M.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mac Grory', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Cutting', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Silver', 'Affiliation': 'Department of Neurology, University of Massachusetts Medical School, Worcester (B.S.).'}, {'ForeName': 'Ava L', 'Initials': 'AL', 'LastName': 'Liberman', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, NY (A.L.L.).'}, {'ForeName': 'Mackenzie P', 'Initials': 'MP', 'LastName': 'Lerario', 'Affiliation': 'Department of Neurology, Weill Cornell Medical College, NY (M.P.L.).'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Furie', 'Affiliation': 'Department of Neurology, The Warren Alpert Medical School of Brown University, Providence, RI (B.M.G., S.C., T.B., K.F.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Grotta', 'Affiliation': 'Department of Neurology, Memorial Hermann Hospital, Texas Medical Center, Houston (J.G.).'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, University of Cincinnati, OH (P.K.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Saver', 'Affiliation': 'Department of Neurology, Ronald Reagan UCLA Medical Center, Santa Monica, CA (J.S.).'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'From the Department of Neurology, New York Langone Health (S.A., E.S., A.L., J.F., K.I., J.T., S.R., S.Y.).'}]",Stroke,['10.1161/STROKEAHA.119.027476']
362,31296328,Primary laparoscopic endorectal pull-through procedure with or without a postoperative rectal tube for hirschsprung disease: a multicenter perspective study.,"BACKGROUND


Hirschsprung-associated enterocolitis (HAEC) is a significant complication of HD both in the pre- and postoperative periods. This was a large multicenter series study to determine the effect of preserving a postoperative rectal tube on preventing HAEC after primary laparoscopic endorectal pull-through procedure.
METHODS


Between 2014 and 2017, a total of 383 consecutive patients with rectosigmoid segment HD were randomly divided into group A (n = 190) and group B (n = 193). All of them underwent primary laparoscopic pull-through procedure, with the same postoperative treatment protocols except for group A with a rectal tube after surgery for 5 days, while group B did not have it. The mean time of follow-up was 2.0 ± 0.53 years (0.5-3.6 years). Demographics, operative data, postoperative complications, and clinical outcomes were compared between these two groups.
RESULTS


Outcomes within 1 month after surgery indicated a lower incidence of abdominal distention (4% vs 15.5%, P < 0.05) and postoperative HAEC (1.2% vs 6.8%, P < 0.05) in group A compared to group B. Beyond 1 month after surgery, the overall incidence of HAEC was not significantly different (12% vs 13.1%, P = 0.54). However, further analysis revealed that the patients who suffered HAEC twice or above twice in group A were significantly less than those in group B (3.6% vs 8.3%, p = 0.02). There were no significant differences in the defecation frequency and other complications.
CONCLUSIONS


Primary laparoscopic endorectal pull-through procedure with a postoperative rectal tube can reduce the early-stage postoperative incidence of abdominal distension and HAEC and the risk of HAEC recurrence in the long term, and is beneficial to postoperative management.
LEVEL OF EVIDENCE


Level 2.",2020,"There were no significant differences in the defecation frequency and other complications.
","['Between 2014 and 2017, a total of 383 consecutive patients with rectosigmoid segment HD']",['Primary Laparoscopic Endorectal Pull-Through Procedure'],"['abdominal distention', 'Demographics, operative data, postoperative complications, and clinical outcomes', 'defecation frequency and other complications', 'overall incidence of HAEC', 'postoperative HAEC']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521377', 'cui_str': 'Rectum and sigmoid colon, CS'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0000731', 'cui_str': 'Swollen abdomen (finding)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",383.0,0.0560268,"There were no significant differences in the defecation frequency and other complications.
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatric Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Pediatric Surgery, Capital Institute of Pediatrics, Beijing, People's Republic of China.""}, {'ForeName': 'Suo-Lin', 'Initials': 'SL', 'LastName': 'Li', 'Affiliation': 'Department of Pediatric Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Shui-Xue', 'Initials': 'SX', 'LastName': 'Li', 'Affiliation': ""Department of Pediatric Surgery, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China.""}, {'ForeName': 'Xiao-Ye', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatric Surgery, Tianjin Children's Hospital, Tianjin, China.""}, {'ForeName': 'Shao-Tao', 'Initials': 'ST', 'LastName': 'Tang', 'Affiliation': 'Department of Pediatric Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China. Electronic address: tshaotao83@126.com.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.06.013']
363,32089338,Is Bilateral Mental Incisive Nerve Block Better than Unilateral Mental Incisive Nerve Block during the Endodontic Management of Mandibular Incisors with Symptomatic Irreversible Pulpitis? A Prospective Single-blind Randomized Clinical Trial.,"INTRODUCTION


The purpose of this clinical trial was to comparatively evaluate the anesthetic efficacy of unilateral and bilateral mental incisive nerve block (MINB) during the endodontic treatment of inflamed mandibular incisors.
METHODS


The study was designed as a crossover single-blind study. A total of 76 patients requiring endodontic intervention in at least 2 mandibular incisors participated in this trial. The patients randomly received unilateral or bilateral MINB of 1.8 mL of 2% lidocaine with 1:80,000 epinephrine at 2 separate appointments. To blind the procedure, a saline injection was given on the contralateral side in the unilateral injections. The endodontic procedure was initiated in the incisors on the side of the first anesthetic injection. Patients with a negative response to electric testing received endodontic access opening under rubber dam. Patients were asked to report pain, if any, during the endodontic procedure by using a Heft-Parker visual analog scale. The anesthetic success was defined as no or mild pain on Heft-Parker visual analog scale (score, 0-54). The statistical analysis was performed with McNemar tests at P values <.05.
RESULTS


The success rates of unilateral MINB and bilateral MINB were 38% and 64%, respectively, for the central incisors and 44% and 69%, respectively, for the lateral incisors. The difference was statistically significant (P < .05).
CONCLUSIONS


The bilateral MINB was more successful during the endodontic management of mandibular incisors with inflamed pulps. However, both the techniques failed to give 100% success rates.",2020,"The success rates of unilateral MINB and bilateral MINB were 38% and 64%, respectively, for the central incisors and 44% and 69%, respectively, for the lateral incisors.","['76 patients requiring endodontic intervention in at least 2 mandibular incisors participated in this trial', 'inflamed mandibular incisors']","['saline injection', 'unilateral and bilateral mental incisive nerve block (MINB', 'endodontic access opening under rubber dam', 'unilateral or bilateral MINB of 1.8\xa0mL of 2% lidocaine with 1:80,000 epinephrine', 'Unilateral Mental Incisive Nerve Block']","['anesthetic success', 'anesthetic efficacy', 'mild pain on Heft-Parker visual analog scale', 'success rates of unilateral MINB and bilateral MINB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0085275', 'cui_str': 'Rubberdam'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]",76.0,0.273114,"The success rates of unilateral MINB and bilateral MINB were 38% and 64%, respectively, for the central incisors and 44% and 69%, respectively, for the lateral incisors.","[{'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India. Electronic address: drvivekaggarwal@gmail.com.'}, {'ForeName': 'Satnam', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Satinder Pal', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Krishan', 'Initials': 'K', 'LastName': 'Gauba', 'Affiliation': 'Oral Health Sciences Centre, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}]",Journal of endodontics,['10.1016/j.joen.2020.01.008']
364,30684635,The Effect of 20-Minute Mindful Breathing on the Rapid Reduction of Dyspnea at Rest in Patients With Lung Diseases: A Randomized Controlled Trial.,"CONTEXT


Dyspnea is a common and distressing symptom in respiratory diseases. Despite advances in the treatment of various lung diseases, the treatment modalities for dyspnea remain limited.
OBJECTIVES


This study aims to examine the effect of 20-minute mindful breathing on the rapid reduction of dyspnea at rest in patients with lung cancer, chronic obstructive pulmonary disease, and asthma.
METHODS


We conducted a parallel-group, nonblinded, randomized controlled trial of standard care plus 20-minute mindful breathing vs. standard care alone for patients with moderate to severe dyspnea due to lung disease, named previously, at the respiratory unit of University Malaya Medical Centre in Malaysia, from August 1, 2017, to March 31, 2018.
RESULTS


Sixty-three participants were randomly assigned to standard care plus a 20-minute mindful breathing session (n = 32) or standard care alone (n = 31), with no difference in their demographic and clinical characteristics. There was statistically significant reduction in dyspnea in the mindful breathing group compared with the control group at minute 5 (U = 233.5, n 1  = 32, n 2  = 31, mean rank 1  = 23.28, mean rank 2  = 37.72, z = -3.574, P < 0.001) and minute 20 (U = 232.0, n 1  = 32, n 2  = 31, mean rank 1  = 23.00, mean rank 2  = 36.77, z = -3.285, P = 0.001).
CONCLUSION


Our results provide evidence that a single session of 20-minute mindful breathing is effective in reducing dyspnea rapidly for patients with lung cancer, chronic obstructive pulmonary disease, and asthma.",2019,"There was statistically significant reduction in dyspnea in the mindful breathing group compared with the control group at minute 5 (U = 233.5, n 1  = 32, n 2  = 31, mean rank 1  = 23.28, mean rank 2  = 37.72, z = -3.574, P < 0.001) and minute 20","['patients with moderate to severe dyspnea due to lung disease, named previously, at the respiratory unit of University Malaya Medical Centre in Malaysia, from August 1, 2017, to March 31,\xa02018', 'Patients', 'With Lung Diseases', 'Sixty-three participants', 'patients with lung cancer, chronic obstructive pulmonary disease, and asthma']","['standard care plus a 20-minute mindful breathing session', '20-Minute Mindful Breathing', 'standard care plus 20-minute mindful breathing vs. standard care alone', 'standard care alone', '20-minute mindful breathing']","['dyspnea', 'Dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0445531', 'cui_str': 'Malaya (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}]",63.0,0.0836272,"There was statistically significant reduction in dyspnea in the mindful breathing group compared with the control group at minute 5 (U = 233.5, n 1  = 32, n 2  = 31, mean rank 1  = 23.28, mean rank 2  = 37.72, z = -3.574, P < 0.001) and minute 20","[{'ForeName': 'Seng-Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chong-Kin', 'Initials': 'CK', 'LastName': 'Liam', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Yong-Kek', 'Initials': 'YK', 'LastName': 'Pang', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Leh-Ching Ng', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Kota Samarahan, Sarawak, Malaysia.'}, {'ForeName': 'Tat-Seng', 'Initials': 'TS', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Wei-Shen Khoo', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chieh-Yin', 'Initials': 'CY', 'LastName': 'Ooi', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chee-Shee', 'Initials': 'CS', 'LastName': 'Chai', 'Affiliation': 'Department of Medicine, Faculty of Medicine and Health Science, University Malaysia Sarawak, Kota Samarahan, Sarawak, Malaysia. Electronic address: cschai@unimas.my.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.01.009']
365,30776537,The Burden of Opioid Adverse Events and the Influence on Cancer Patients' Symptomatology.,"CONTEXT


Opioids are frequently used for the treatment of moderate-to-severe pain and their use may produce a number of unwanted adverse events (AEs).
OBJECTIVES


The objective of this study was to understand the burden of opioid-induced AEs in cancer patients with pain after the introduction of strong opioids (WHO Step III).
METHODS


This is a cohort study derived from a randomized controlled trial involving 498 cancer patients with pain who received strong opioids. During 28-day follow-up, we analyzed frequency, intensity, and changes over time of the main opioid-induced AEs; the influence of previous pain therapy on AEs; and the relationships between the presence of AEs and analgesic response.
RESULTS


After starting strong opioids, dry mouth, nausea, and vomiting immediately increased and persisted over time, constipation continued to increase, while drowsiness and confusion tended to decrease. Patients previously treated with weak opioids had more frequent and severe AEs. While at all observation points the percentage of patients without AEs was 37%-39%, considering all the five scheduled visits, from Day 3 to Day 28, 17% of patients never experienced any AEs, while 48% of patients had four or more concomitant AEs. Patients with no AEs experienced significantly lower pain intensity.
CONCLUSION


Opioid introduction induces various AEs that persist over time and worse patients' symptomatology. Moreover, there seems to be a different expression of the opioid toxicity among patients, and a possible interaction between AEs and the analgesic response. The balance between the opioids analgesic effect and induced toxicity is fundamental in deciding the best management for pain in cancer patients.",2019,"Patients with no AEs experienced significantly lower pain intensity.
","['cancer patients with pain after the introduction of strong opioids (WHO Step III', '498 cancer patients with pain who received strong opioids', 'pain in cancer patients']",[],"['frequent and severe AEs', 'nausea, and vomiting', 'drowsiness and confusion', 'pain intensity']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439070', 'cui_str': 'III'}]",[],"[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",498.0,0.139262,"Patients with no AEs experienced significantly lower pain intensity.
","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Corli', 'Affiliation': 'Department of Oncology, Unit of Pain and Palliative Care Research, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy. Electronic address: oscar.corli@marionegri.it.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Santucci', 'Affiliation': 'Department of Oncology, Unit of Cancer Epidemiology, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Corsi', 'Affiliation': 'Department of Oncology, Unit of Pain and Palliative Care Research, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Radrezza', 'Affiliation': 'Department of Public Health, Laboratory for Public Health, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Department of Oncology, Unit of Statistics, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bosetti', 'Affiliation': 'Department of Oncology, Unit of Cancer Epidemiology, Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.02.009']
366,32227755,Initial Invasive or Conservative Strategy for Stable Coronary Disease.,"BACKGROUND


Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain.
METHODS


We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction.
RESULTS


Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32).
CONCLUSIONS


Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","['patients with stable coronary disease and moderate or severe ischemia', 'Stable Coronary Disease', '5179 patients with moderate or severe ischemia to an']","['initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed', 'invasive intervention plus medical therapy']","['death from cardiovascular causes or myocardial infarction', 'risk of ischemic cardiovascular events or death', 'definition of myocardial infarction', 'procedural myocardial infarctions of uncertain clinical importance', 'composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'cumulative event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5179.0,0.217237,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mangalath N', 'Initials': 'MN', 'LastName': 'Krishnan', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Whady A', 'Initials': 'WA', 'LastName': 'Hueb', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Peteiro', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Miller', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kirby', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Neal O', 'Initials': 'NO', 'LastName': 'Jeffries', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'T Bruce', 'Initials': 'TB', 'LastName': 'Ferguson', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Williams', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915922']
367,31663814,Task-Specific Sensitivity in Physical Function Testing Predicts Outcome in Patients With Low Back Pain.,"OBJECTIVE


To investigate the prognostic value of task-specific sensitivity in patients with low back pain by exploring whether task-specific sensitivity during physical function testing was associated with self-reported change in pain and disability.
DESIGN


Prospective cohort study nested in a randomized controlled trial.
METHODS


The study included 260 patients with low back pain, referred for evaluation in a secondary care setting. All patients completed questionnaires and underwent clinical examination by a physical therapist. Patients rated their pain intensity before and after completing a test battery measuring physical function and were classified into 4 categories-worse, unchanged, better, or no pain-depending on their pain response. At 3-month follow-up, outcomes were obtained by a postal questionnaire.
RESULTS


Task-specific sensitivity significantly predicted pain, after adjusting for known prognostic factors. Patients in the no pain, better, and unchanged groups improved their pain score significantly more than patients in the worse pain group. Patients in the no pain group also improved their disability score significantly more compared to patients in the worse pain group, after adjusting for known prognostic factors.
CONCLUSION


Task-specific sensitivity predicted pain intensity after 3 months in patients with low back pain. The prognostic value appears limited with respect to disability. J Orthop Sports Phys Ther 2020;50(4):206-213. Epub 30 Oct 2019. doi:10.2519/jospt.2020.8953.",2020,"Patients classified as  no pain  also improved significantly more in disability score compared to patients classified as  worse  after adjusting for known prognostic factors.
","['260 patients with LBP, referred for evaluation in secondary care setting', 'Low back pain (LBP', 'patients with LBP', 'Patients With Low Back Pain']",[],"['pain score', 'pain intensity', 'disability score']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",260.0,0.0711021,"Patients classified as  no pain  also improved significantly more in disability score compared to patients classified as  worse  after adjusting for known prognostic factors.
","[{'ForeName': 'Nûno', 'Initials': 'N', 'LastName': 'Trolle', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maribo', 'Affiliation': ''}, {'ForeName': 'Lone Donbæk', 'Initials': 'LD', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'David Høyrup', 'Initials': 'DH', 'LastName': 'Christiansen', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.8953']
368,32144515,Alvogyl and absorbable gelatin sponge as palatal wound dressings following epithelialized free gingival graft harvest: a randomized clinical trial.,"OBJECTIVES


This randomized controlled trial compares for the first time effects of Alvogyl versus absorbable gelatin sponge as palatal wound dressings on postoperative pain, amount of analgesic consumption, post-surgical bleeding, and wound re-epithelization.
MATERIALS AND METHODS


Following sample size calculation, 36 systemically healthy patients requiring palatal mucosal graft harvesting were randomized to receive Alvogyl (intervention group, 18 patients) or absorbable gelatin sponge (control group, 18 patients) palatal dressings. Patient-reported VAS pain scores over 2 weeks were defined as primary outcome. Post-surgical bleeding, number of analgesics consumed, and complete re-epithelialization of the palatal wound for up to 5 weeks were defined as secondary outcomes.
RESULTS


Although significantly higher VAS pain scores were reported in the control as compared with the intervention group up to 12 days post-surgically (from (median [range]) 8.5 [2-10] to 1 [0-2] and from 6 [0-10] to 0 [0-2] respectively), with higher analgesics consumption (from 2 [1-3] to 1 [0-3] and from 1 [0-3] to 0 [0-2] tablets respectively), a multivariate regression analysis considering age, gender, graft width/length, tissue thickness, analgesics intake, and dressing type demonstrated no statistically significant effect of any factor, including dressing type on VAS pain scores. At 4 weeks, 22.2% of patients in the intervention group versus 11.1% in the control group demonstrated complete re-epithelization of their palatal engraftment site, before complete re-epithelization in both groups at 5 weeks. No post-surgical bleeding was reported with both dressings.
CONCLUSIONS


Within the study's limitations, results suggest Alvogyl as a practical palatal surgical dressing, comparable with absorbable gelatin sponge in cost, pain reduction, hemostasis, and re-epithelization properties.
TRIAL REGISTRATION


www.ClinicalTrials.gov Identifier: NCT03402321 CLINICAL RELEVANCE: Alvogyl could present a novel palatal wound dressing material, comparable with gelatin sponge.",2020,Although significantly higher VAS pain scores were reported in the control as compared with the intervention group up to 12 days,"['36 systemically healthy patients requiring palatal mucosal graft harvesting', 'epithelialized free gingival graft harvest']","['absorbable gelatin sponge', 'Alvogyl (intervention', 'Alvogyl and absorbable gelatin sponge', 'Alvogyl versus absorbable gelatin sponge', 'absorbable gelatin sponge (control group, 18 patients) palatal dressings', 'gelatin sponge']","['postoperative pain, amount of analgesic consumption, post-surgical bleeding, and wound re-epithelization', 'Post-surgical bleeding, number of analgesics consumed, and complete re-epithelialization of the palatal wound', 'cost, pain reduction, hemostasis, and re-epithelization properties', 'analgesics consumption', 'VAS pain scores', 'complete re-epithelization of their palatal engraftment site']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft (substance)'}, {'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site (procedure)'}]","[{'cui': 'C0017238', 'cui_str': 'Gelatin Sponge, Absorbable'}, {'cui': 'C0051530', 'cui_str': 'alvogyl'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0334221', 'cui_str': 'Re-Epithelialization'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",36.0,0.13495,Although significantly higher VAS pain scores were reported in the control as compared with the intervention group up to 12 days,"[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Ehab', 'Affiliation': 'Private dental clinic, Fayyoum, Egypt.'}, {'ForeName': 'Omneya', 'Initials': 'O', 'LastName': 'Abouldahab', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Oral and Dental Medicine, Cairo University, Giza, Egypt.'}, {'ForeName': 'Abdallah', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Periodontology Department, School of Dentistry, New Giza University, Giza, Egypt.'}, {'ForeName': 'Karim M', 'Initials': 'KM', 'LastName': 'Fawzy El-Sayed', 'Affiliation': 'Oral Medicine and Periodontology Department, Faculty of Oral and Dental Medicine, Cairo University, Giza, Egypt. karim.fawzy@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-020-03254-z']
369,30091121,Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification.,"BACKGROUND


Despite widespread implementation of mammographic breast density (MBD) notification laws, the impact of these laws on knowledge of MBD and knowledge of breast cancer risk is limited by the lack of tools to promote informed decision-making in practice.
OBJECTIVE


To develop and evaluate whether brief, personalized informational videos following a normal mammogram in addition to a legislatively required letter about MBD result can improve knowledge of MBD and breast cancer risk compared to standard care (i.e., legislatively required letter about MBD included with the mammogram result).
DESIGN/PARTICIPANTS


Prospective randomized controlled trial of English-speaking women, age 40-74 years, without prior history of breast cancer, receiving a screening mammogram with a normal or benign finding (intervention group n = 235, control group n = 224).
INTERVENTION


brief (3-5 min) video, personalized to a woman's MBD result and breast cancer risk.
MAIN MEASURES


Primary outcomes were a woman's knowledge of her MBD and risk of breast cancer. Secondary outcomes included whether a woman reported that she discussed the results of her mammogram with her primary care provider (PCP).
KEY RESULTS


Relative to women in the control arm, women in the intervention arm had greater improvement in their knowledge of both their personal MBD (intervention pre/post 39.2%/ 77.5%; control pre/post 36.2%/ 37.5%; odds ratio (OR) 5.34 for change for intervention vs. control, 95% confidence interval (CI) 3.87-7.36; p < 0.001) and risk of breast cancer (intervention pre/post: 66.8%/74.0%; control pre/post 67.9%/ 65.2%; OR 1.42, 95% confidence interval (CI) 1.09-1.84; p = 0.01). Women in the intervention group were more likely than those in the control group to report discussing the results of their mammogram with their PCP (p = 0.05).
CONCLUSIONS


Brief, personalized videos following mammography can improve knowledge of MBD and personal risk of breast cancer compared to a legislatively mandated informational letter. Trial Registration Clinicaltrials.gov (NCT02986360).",2019,"Women in the intervention group were more likely than those in the control group to report discussing the results of their mammogram with their PCP (p = 0.05).
","['English-speaking women, age 40-74\xa0years, without prior history of breast cancer, receiving a screening mammogram with a normal or benign finding (intervention group n\u2009=\u2009235, control group n\u2009=\u2009224']",[],"['knowledge of both their personal MBD', ""woman's knowledge of her MBD and risk of breast cancer"", 'risk of breast cancer', 'knowledge of MBD and personal risk of breast cancer', 'knowledge of MBD and breast cancer risk', 'woman reported that she discussed the results of her mammogram with her primary care provider (PCP']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319560', 'cui_str': '224'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}]",,0.0436342,"Women in the intervention group were more likely than those in the control group to report discussing the results of their mammogram with their PCP (p = 0.05).
","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Haas', 'Affiliation': ""Division of General Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. jhaas@bwh.harvard.edu.""}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Giess', 'Affiliation': ""Department of Radiology, Division of Breast Imaging, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Harris', 'Affiliation': ""Division of General Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ansolabehere', 'Affiliation': ""Division of General Medicine and Primary Care, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Celia P', 'Initials': 'CP', 'LastName': 'Kaplan', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-018-4622-4']
370,30520208,Testosterone therapy to prevent type 2 diabetes mellitus in at-risk men (T4DM): Design and implementation of a double-blind randomized controlled trial.,"BACKGROUND


Low circulating testosterone is associated with an increased risk of developing type 2 diabetes (T2DM) in overweight men with impaired glucose tolerance (IGT).
AIMS


To determine in a multi-centre, double-blinded placebo-controlled randomized trial whether testosterone treatment combined with lifestyle intervention (Weight Watchers) relative to lifestyle intervention alone reduces T2DM incidence and improves glucose tolerance at 2 years.
STUDY POPULATION


Overweight or obese men aged 50-74 years with a serum testosterone of ≤14 nmol/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT).
SETTING, DRUG AND PROTOCOL


Six Australian capital city-based tertiary care centres. Participants were randomized 1:1 and injected with testosterone undecanoate (1000 mg/4 mL) or vehicle (4 mL castor oil), at baseline, 6 weeks and 3-monthly thereafter. PRIMARY ENDPOINTS: (a) Proportion of participants with 2-hour OGTT ≥11.1 mmol/L at 2 years, and (b) a difference at 2 years ≥0.6 mmol/L in the mean 2-hour OGTT glucose between treatments.
SECONDARY ENDPOINTS


Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs.
SAFETY


Overseen by an Independent Data Safety Monitoring Committee. Haematocrit, lipids and prostate-specific antigen (PSA) are assessed 6-monthly and information relating to haematological, urological and cardiovascular adverse events from each clinic visit. SUB-STUDIES: (a) Changes in bone density and micro-architecture, (b) motivation and behaviour, (c) telomere length, (d) extended treatment up to 4 years, and (e) hypothalamo-pituitary testicular axis recovery at treatment end.",2019,"Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs.
","['type 2 diabetes mellitus in at-risk men (T4DM', 'Six Australian capital city-based tertiary care centres', 'Overweight or obese men aged 50-74\u2009years with a serum testosterone of ≤14\u2009nmol/L and IGT or newly diagnosed T2DM established by an oral glucose tolerance test (OGTT', 'overweight men with impaired glucose tolerance (IGT']","['testosterone treatment combined with lifestyle intervention (Weight Watchers) relative to lifestyle intervention', 'testosterone undecanoate', 'placebo', 'Testosterone therapy']","['Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs', 'Haematocrit, lipids and prostate-specific antigen (PSA', 'T2DM incidence and improves glucose tolerance', 'bone density and micro-architecture, (b) motivation and behaviour, (c) telomere length, (d) extended treatment up to 4 years, and (e) hypothalamo-pituitary testicular axis recovery']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0076195', 'cui_str': 'testosterone undecanoate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}]",,0.468761,"Fasting insulin, HbA1c, body composition, maximal handgrip strength; sexual function and lower urinary tract symptoms; serum sex steroids and sex hormone binding globulin; mood and psychosocial function; adherence to lifestyle intervention; and healthcare utilization and costs.
","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wittert', 'Affiliation': 'Freemasons Foundation Centre for Mens Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Atlantis', 'Affiliation': 'Freemasons Foundation Centre for Mens Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Allan', 'Affiliation': 'Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bracken', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Conway', 'Affiliation': 'Anzac Research Institute and Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Daniel', 'Affiliation': 'Health Research Institute, University of Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Dept. of Medicine, The Austin Hospital and University of Melbourne, Victoria, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hague', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Handelsman', 'Affiliation': 'Anzac Research Institute and Andrology Department, Concord Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Warrick', 'Initials': 'W', 'LastName': 'Inder', 'Affiliation': 'Department of Diabetes and Endocrinology, Princess Alexandra Hospital and University of Queensland, Woolloongabba, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Department of Clinical Research, Hudson Institute of Medical Research, Melbourne, Australia.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Robledo', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Stuckey', 'Affiliation': 'Keogh Institute for Medical Research, Department of Endocrinology and Diabetes, Sir Charles Gairdner Hospital, Nedlands, Western Australia, and Medical School, University of Western Australia, Perth, Western Australia.'}, {'ForeName': 'Bu B', 'Initials': 'BB', 'LastName': 'Yeap', 'Affiliation': 'Department of Endocrinology and Diabetes, Fiona Stanley Hospital, and Medical School University of Western Australia, Perth, Western Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13601']
371,30520216,"A whey/guar ""preload"" improves postprandial glycaemia and glycated haemoglobin levels in type 2 diabetes: A 12-week, single-blind, randomized, placebo-controlled trial.","AIMS


To evaluate the effects of 12 weeks of treatment with a whey/guar preload on gastric emptying, postprandial glycaemia and glycated haemoglobin (HbA1c) levels in people with type 2 diabetes (T2DM).
MATERIALS AND METHODS


A total of 79 people with T2DM, managed on diet or metformin (HbA1c 49 ± 0.7 mmol/mol [6.6 ± 0.1%]), were randomized, in single-blind fashion, to receive 150 mL flavoured preloads, containing either 17 g whey protein plus 5 g guar (n = 37) or flavoured placebo (n = 42), 15 minutes before two meals, each day for 12 weeks. Blood glucose and gastric emptying (breath test) were measured before and after a mashed potato meal at baseline (without preload), and after the preload at the beginning (week 1) and end (week 12) of treatment. HbA1c levels, energy intake, weight and body composition were also evaluated.
RESULTS


Gastric emptying was slower (P < 0.01) and postprandial blood glucose levels lower (P < 0.05) with the whey/guar preload compared to placebo preload, and the magnitude of reduction in glycaemia was related to the rate of gastric emptying at both week 1 (r = -0.54, P < 0.001) and week 12 (r = -0.54, P < 0.0001). At the end of treatment, there was a 1 mmol/mol [0.1%] reduction in HbA1c in the whey/guar group compared to the placebo group (49 ± 1.0 mmol/mol [6.6 ± 0.05%] vs. 50 ± 0.8 mmol/mol [6.7 ± 0.05%]; P < 0.05). There were no differences in energy intake, body weight, or lean or fat mass between the groups.
CONCLUSIONS


In patients with well-controlled T2DM, 12 weeks' treatment with a low-dose whey/guar preload, taken twice daily before meals, had sustained effects of slowing gastric emptying and reducing postprandial blood glucose, which were associated with a modest reduction in HbA1c, without causing weight gain.",2019,"RESULTS


Gastric emptying was slower (P < 0.01) and postprandial blood glucose levels lower (P < 0.05) with the whey/guar preload compared to placebo preload, and the magnitude of reduction in glycaemia was related to the rate of gastric emptying at both week 1 (r = -0.54, P < 0.001) and week 12 (r = -0.54, P < 0.0001).","['2 diabetes', 'people with type 2 diabetes (T2DM', '79 people with T2DM, managed on diet or metformin (HbA1c 49\u2009±\u20090.7\u2009mmol/mol [6.6\u2009±\u20090.1']","['whey/guar preload', '150\u2009mL flavoured preloads, containing either 17\u2009g whey protein plus 5\u2009g guar (n\u2009=\u200937) or flavoured placebo', 'guar ""preload', 'placebo']","['energy intake, body weight, or lean or fat mass', 'HbA1c levels, energy intake, weight and body composition', 'postprandial blood glucose levels', 'Blood glucose and gastric emptying (breath test', 'rate of gastric emptying', 'reduction in HbA1c', 'Gastric emptying', 'glycaemia', 'postprandial blood glucose', 'postprandial glycaemia and glycated haemoglobin levels', 'gastric emptying, postprandial glycaemia and glycated haemoglobin (HbA1c) levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0452720', 'cui_str': 'Whey'}, {'cui': 'C0996821', 'cui_str': 'Cyamposis'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2711895', 'cui_str': '17G (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0006153', 'cui_str': 'Breath Tests'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}]",79.0,0.0674323,"RESULTS


Gastric emptying was slower (P < 0.01) and postprandial blood glucose levels lower (P < 0.05) with the whey/guar preload compared to placebo preload, and the magnitude of reduction in glycaemia was related to the rate of gastric emptying at both week 1 (r = -0.54, P < 0.001) and week 12 (r = -0.54, P < 0.0001).","[{'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Watson', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Bound', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Checklin', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Grivell', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'Departments of Endocrinology and Gastroenterology, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Discipline of Medicine, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13604']
372,30520221,"Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centre, randomized, controlled trial.","AIMS


To compare the efficacy and safety of saxagliptin and glimepiride in type 2 diabetes (T2D) patients who are inadequately controlled with metformin monotherapy.
MATERIALS AND METHODS


In this 48-week, multi-centre, open-label, randomized, parallel trial (NCT02280486, clinicaltrials.gov), a total of 388 T2D patients were randomized 1:1 to saxagliptin or glimepiride groups. The primary endpoint was achievement of HbA1c <7.0%, without hypoglycaemia, defined as blood glucose <3.9 mmol/L and weight gain <3.0% after 48 weeks of treatment.
RESULTS


Over 48 weeks, a greater proportion of patients achieved the primary endpoint with saxagliptin compared with glimepiride (43.3% vs 31.3%; odds ratio, 1.38, 95% CI, 1.05-1.82; P = 0.019), especially among patients with baseline HbA1c <8.0%, duration <5 years or baseline BMI ≥25 kg/m 2  . Mean reduction in HbA1c was similar in the two treatment groups at Week 48 (-0.94% with saxagliptin vs -0.98% with glimepiride; P = 0.439). Bodyweight decreased with saxagliptin, but increased with glimepiride over the treatment period, and the treatment difference was -1.6 kg (P < 0.001) at Week 48. The proportion of patients experiencing hypoglycaemia was much lower with saxagliptin vs glimepiride (3.1% vs 12.8%; P < 0.001).
CONCLUSIONS


This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes.",2019,Mean reduction in HbA1c was similar in the two treatment groups at Week 48 (-0.94% with saxagliptin vs -0.98% with glimepiride; P = 0.439).,"['type 2 diabetes (T2D) patients who are inadequately controlled with metformin monotherapy', 'patients uncontrolled with metformin therapy', 'T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes', '388 T2D patients']","['saxagliptin vs glimepiride', 'glimepiride, saxagliptin', 'saxagliptin or glimepiride', 'glimepiride', 'saxagliptin and glimepiride', 'saxagliptin']","['proportion of patients experiencing hypoglycaemia', 'Mean reduction in HbA1c', 'achievement of HbA1c <7.0%, without hypoglycaemia, defined as blood glucose <3.9 mmol/L and weight gain', 'efficacy and safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}]","[{'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",388.0,0.142279,Mean reduction in HbA1c was similar in the two treatment groups at Week 48 (-0.94% with saxagliptin vs -0.98% with glimepiride; P = 0.439).,"[{'ForeName': 'Tianwei', 'Initials': 'T', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Liangying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology, Huai'an First People's Hospital, Huai'an, China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Department of Endocrinology, Wuxi First People's Hospital, Wuxi, China.""}, {'ForeName': 'Jinluo', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ""Department of Endocrinology, Changzhou Second People's Hospital affiliated to Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Bimin', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing Pukou District Central Hospital, Nanjing, China.'}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Shao', 'Affiliation': 'Department of Endocrinology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Zilin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing, China.'}, {'ForeName': 'Shao', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': ""Department of Endocrinology, Kunshan First People's Hospital, Suzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Dalong', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13605']
373,31022069,A Randomized Controlled Trial Comparing rhBMP-2/Absorbable Collagen Sponge Versus Autograft for the Treatment of Tibia Fractures With Critical Size Defects.,"OBJECTIVES


To compare radiographic union of tibia fractures with bone defects treated with recombinant bone morphogenetic protein-2 (rhBMP-2) with allograft to autogenous iliac crest bone graft (ICBG).
DESIGN


FDA-regulated multicenter randomized trial.
SETTING


Sixteen US trauma centers.
PATIENTS/PARTICIPANTS


Thirty patients (18-65 years of age) with Type II, IIIA, or IIIB open tibia fracture and bone defect treated with an intramedullary nail.
INTERVENTION


rhBMP-2 (n = 16) versus ICBG (n = 14).
MAIN OUTCOME MEASUREMENTS


Radiographic union within 52 weeks. Secondary outcomes included clinical healing, patient-reported function, major complications, and treatment cost. Equivalence was evaluated by testing whether a 90% two-sided confidence interval for the difference in the probability of radiographic union between rhBMP-2 or ICBG is contained with the interval [220% to +20%]. A post hoc Bayesian analysis, using data from a previous trial, was also conducted.
RESULTS


Twenty-three patients had union data at 52 weeks: 7/12 (58.3%) rhBMP-2 were radiographically united compared with 9/11 (81.8%) ICBG, resulting in a treatment difference of -0.23 (90% CI: -0.55 to 0.10). Patients treated with rhBMP-2 had lower rates of clinical healing at 52 weeks (27% vs. 54%), higher mean Short Musculoskeletal Function Assessment scores (dysfunction: 33.3 vs. 23.7; bother score: 32.8 vs. 21.4) and experienced more complications (5 vs. 3). Mean treatment cost for rhBMP-2 was estimated at $14,155 versus $9086 for ICBG.
CONCLUSIONS


These data do not provide sufficient evidence to conclude that ICBG and rhBMP-2 are equivalent regarding radiographic union.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2019,"These data do not provide sufficient evidence to conclude that ICBG and rhBMP-2 are equivalent regarding radiographic union.
","['Tibia Fractures with Critical Size Defects', '30 patients aged (8-65) with Type II, IIIA or IIIB open tibia fracture and bone defect treated with an intramedullary nail', '16 U.S. trauma centers']","['rhBMP-2', 'rhBMP-2/ACS vs. Autograft', 'Recombinant bone morphogenetic protein-2 (rhBMP-2) with allograft', 'autogenous iliac crest bone graft (ICBG', 'rhBMP-2 (n=16) versus ICBG']","['Radiographic union', 'clinical healing, patient-reported function, major complications, and treatment cost', 'ICBG', 'Mean treatment cost for rhBMP-2', 'mean SMFA scores (dysfunction', 'probability of radiographic union', 'rates of clinical healing']","[{'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0336581', 'cui_str': 'Intramedullary rod, device (physical object)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}]","[{'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C1445578', 'cui_str': 'rhBMP-2 protein, recombinant'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0223651', 'cui_str': 'Iliac Crest'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",30.0,0.233046,"These data do not provide sufficient evidence to conclude that ICBG and rhBMP-2 are equivalent regarding radiographic union.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001492']
374,32151570,A community-based effort to increase the rate of follow-up eye examinations of school-age children who fail vision screening: a randomized clinical trial.,"PURPOSE


To determine whether enhanced follow-up after failed vision screening, involving more communication with parents/guardians than occurs in a standard protocol, would result in a higher rate of post-screening examination by an eye care provider.
METHODS


In a study conducted from January through December 2017, 162 children in first- and third-grade who failed a vision screening in their Wayne County, Michigan, schools were randomly assigned to receive an enhanced or the standard follow-up protocol.
RESULTS


The average age of the children was 7.9 ± 1.1years; 84 (52%) were males. In the enhanced follow-up group, 52 of 80 (65%) had a documented eye examination within 16 weeks of their screening; the rate in those receiving standard follow-up was 48% (39/82). The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%). The enhanced follow-up group's odds of obtaining a documented eye examination was twice that of the standard follow-up group (OR = 2.05; 95% CI, 1.09-3.85; P = 0.026).
CONCLUSIONS


In this study cohort, methods to enhance communication proved effective in increasing the likelihood that children who failed vision screenings would receive an examination by an eye care provider.",2020,"The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%).","['school-age children who fail vision screening', 'January through December 2017, 162 children in first- and third-graders who failed a vision screening in their Wayne County, Michigan, schools', 'The average age of the children was 7.9 ± 1.1years; 84 (52%) were males']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042792', 'cui_str': 'Vision Screening'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],[],,0.120289,"The intergroup difference in follow-up was 17.4% (95% CI, 2.4%-32.5%).","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan. Electronic address: dmusch@med.umich.edu.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Andrews', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Medical School, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schumann', 'Affiliation': 'Department of Health and Human Services, State of Michigan, Lansing, Michigan.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': ""Children's Hospital of Michigan, Detroit, Michigan.""}]",Journal of AAPOS : the official publication of the American Association for Pediatric Ophthalmology and Strabismus,['10.1016/j.jaapos.2019.12.012']
375,31216226,Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer.,"PURPOSE


We report the final, protocol-specified analysis of overall survival (OS) in GOG-0218, a phase III, randomized trial of bevacizumab in women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma.
METHODS


A total of 1,873 women with incompletely resected stage III to IV disease were randomly assigned 1:1:1 to six 21-day cycles of intravenous carboplatin (area under the concentration  v  time curve 6) and paclitaxel (175 mg/m 2 ) versus chemotherapy plus concurrent bevacizumab (15 mg/kg, cycles 2 to 6) versus chemotherapy plus concurrent and maintenance bevacizumab (cycles 2 to 22). Inclusion criteria included a Gynecologic Oncology Group performance status of 0 to 2 and no history of clinically significant vascular events or evidence of intestinal obstruction. OS was analyzed in the intention-to-treat population. A total of 1,195 serum and/or tumor specimens were sequenced for  BRCA1/2  and damaging mutations in homologous recombination repair (HRR) genes. Intratumoral microvessel density was studied using CD31 immunohistochemistry.
RESULTS


Median follow-up was 102.9 months. Relative to control (n = 625), for patients receiving bevacizumab-concurrent (n = 625), the hazard ratio (HR) of death was 1.06 (95% CI, 0.94 to 1.20); for bevacizumab-concurrent plus maintenance (n = 623), the HR was 0.96 (95% CI, 0.85 to 1.09). Disease-specific survival was not improved in any arm. No survival advantage was observed after censoring patients who received bevacizumab at crossover or as second line. Median OS for stage IV bevacizumab-concurrent plus maintenance was 42.8  v  32.6 months for stage IV control (HR, 0.75; 95% CI, 0.59 to 0.95). Relative to wild type, the HR for death for  BRCA1/2  mutated carcinomas was 0.62 (95% CI, 0.52 to 0.73), and for non- BRCA1/2  HRR, the HR was 0.65 (95% CI, 0.51 to 0.85).  BRCA1/2 , HRR, and CD31 were not predictive of bevacizumab activity.
CONCLUSION


No survival differences were observed for patients who received bevacizumab compared with chemotherapy alone. Testing for  BRCA1/2  mutations and homologous recombination deficiency is essential.",2019,Disease-specific survival was not improved in any arm.,"['women with newly diagnosed ovarian, fallopian tube, or primary peritoneal carcinoma', '1,873 women with incompletely resected stage III to IV disease', 'Ovarian Cancer']","['intravenous carboplatin (area under the concentration  v  time curve 6) and paclitaxel', 'bevacizumab', 'Bevacizumab', 'chemotherapy plus concurrent and maintenance bevacizumab', 'bevacizumab-concurrent', 'chemotherapy plus concurrent bevacizumab']","['hazard ratio (HR) of death', 'survival differences', 'Disease-specific survival', 'survival advantage', 'Median OS', 'Intratumoral microvessel density', 'BRCA1/2 , HRR, and CD31', 'vascular events or evidence of intestinal obstruction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}]",1873.0,0.353929,Disease-specific survival was not improved in any arm.,"[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Burger', 'Affiliation': 'University of Pennsylvania Abramson Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Enserro', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Barbara M', 'Initials': 'BM', 'LastName': 'Norquist', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Brady', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bookman', 'Affiliation': 'Permanente Medical Group, San Francisco, CA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'The University of Chicago, Chicago, IL.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Homesley', 'Affiliation': 'Indiana University Medical Center, Indianapolis, IN.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Fowler', 'Affiliation': 'The Ohio State University James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Greer', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Boente', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Sharon X', 'Initials': 'SX', 'LastName': 'Liang', 'Affiliation': 'Western Pennsylvania Hospital, Pittsburgh, PA.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bais', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'California Pacific Medical Center Research Institute, San Francisco, CA.'}, {'ForeName': 'J Stuart', 'Initials': 'JS', 'LastName': 'Ferriss', 'Affiliation': 'Dell Seton Medical Center at The University of Texas, Austin, TX.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': 'University of Cincinnati Cancer Institute, Cincinnati, OH.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'DiSaia', 'Affiliation': 'University of California, Irvine, Medical Center, Orange, CA.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Copeland', 'Affiliation': 'The Ohio State University James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Mannel', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'University of Alabama, Birmingham, AL.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'University of Arizona and Creighton University, Phoenix, AZ.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01009']
376,32227142,Comparison of the Effectiveness of Single-Component and Multicomponent Interventions for Reducing Radiation Doses in Patients Undergoing Computed Tomography: A Randomized Clinical Trial.,"Importance


Computed tomography (CT) radiation doses vary across institutions and are often higher than needed.
Objective


To assess the effectiveness of 2 interventions to reduce radiation doses in patients undergoing CT.
Design, Setting, and Participants


This randomized clinical trial included 864 080 adults older than 18 years who underwent CT of the abdomen, chest, combined abdomen and chest, or head at 100 facilities in 6 countries from November 1, 2015, to September 21, 2017. Data analysis was performed from October 4, 2017, to December 14, 2018.
Interventions


Imaging facilities received audit feedback alone comparing radiation-dose metrics with those of other facilities followed by the multicomponent intervention, including audit feedback with targeted suggestions, a 7-week quality improvement collaborative, and best-practice sharing. Facilities were randomly allocated to the time crossing from usual care to the intervention.
Main Outcomes and Measures


Primary outcomes were the proportion of high-dose CT scans and mean effective dose at the facility level. Secondary outcomes were organ doses. Outcomes after interventions were compared with those before interventions using hierarchical generalized linear models adjusting for temporal trends and patient characteristics.
Results


Across 100 facilities, 864 080 adults underwent 1 156 657 CT scans. The multicomponent intervention significantly reduced proportions of high-dose CT scans, measured using effective dose. Absolute changes in proportions of high-dose scans were 1.1% to 7.9%, with percentage reductions in the proportion of high-dose scans of 4% to 30% (abdomen: odds ratio [OR], 0.82; 95% CI, 0.77-0.88; P < .001; chest: OR, 0.92; 95% CI, 0.86-0.99; P = .03; combined abdomen and chest: OR, 0.49; 95% CI, 0.41-0.59; P < .001; and head: OR, 0.71; 95% CI, 0.66-0.76; P < .001). Reductions in the proportions of high-dose scans were greater when measured using organ doses. The absolute reduction in the proportion of high-dose scans was 6.0% to 17.2%, reflecting 23% to 58% reductions in the proportions of high-dose scans across anatomical areas. Mean effective doses were significantly reduced after multicomponent intervention for abdomen (6% reduction, P < .001), chest (4%, P < .001), and chest and abdomen (14%, P < .001) CT scans. Larger reductions in mean organ doses were 8% to 43% across anatomical areas. Audit feedback alone reduced the proportions of high-dose scans and mean dose, but reductions in observed dose were smaller. Radiologist's satisfaction with CT image quality was unchanged and high during all periods.
Conclusions and Relevance


For imaging facilities, detailed feedback on CT radiation dose combined with actionable suggestions and quality improvement education significantly reduced doses, particularly organ doses. Effects of audit feedback alone were modest.
Trial Registration


ClinicalTrials.gov Identifier: NCT03000751.",2020,"Mean effective doses were significantly reduced after multicomponent intervention for abdomen (6% reduction, P < .001), chest (4%, P < .001), and chest and abdomen (14%, P < .001) CT scans.","['patients undergoing CT', '864\u202f080 adults older than 18 years who underwent CT of the abdomen, chest, combined abdomen and chest, or head at 100 facilities in 6 countries from November 1, 2015, to September 21, 2017', 'Across 100 facilities, 864\u202f080 adults underwent 1\u202f156\u202f657 CT scans', 'Patients Undergoing Computed Tomography']","['Single-Component and Multicomponent Interventions', 'audit feedback alone comparing radiation-dose metrics with those of other facilities followed by the multicomponent intervention', 'Importance\n\n\nComputed tomography (CT) radiation', 'audit feedback alone']","['Mean effective doses', 'chest and abdomen', 'proportions of high-dose CT scans', 'proportion of high-dose CT scans and mean effective dose at the facility level', ""Radiologist's satisfaction with CT image quality""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0260194', 'cui_str': 'Radiologist (occupation)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",864080.0,0.150159,"Mean effective doses were significantly reduced after multicomponent intervention for abdomen (6% reduction, P < .001), chest (4%, P < .001), and chest and abdomen (14%, P < .001) CT scans.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Smith-Bindman', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chu', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chung', 'Affiliation': 'Department of Demography, University of California, Berkeley.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Lopez-Solano', 'Affiliation': 'Department of Radiology and Biomedical Imaging, University of California, San Francisco.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Einstein', 'Affiliation': 'Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Solberg', 'Affiliation': 'HealthPartners Institute, Minneapolis, Minnesota.'}, {'ForeName': 'Luisa F', 'Initials': 'LF', 'LastName': 'Cervantes', 'Affiliation': ""Nicklaus Children's Hospital, Miami, Florida.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yellen-Nelson', 'Affiliation': 'Department of Radiology, University of California, San Diego.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Boswell', 'Affiliation': 'Department of Radiology, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Delman', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Phuong-Anh', 'Initials': 'PA', 'LastName': 'Duong', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Allen R', 'Initials': 'AR', 'LastName': 'Goode', 'Affiliation': 'Department of Radiology and Medical Imaging, University of Virginia Health System, Virginia.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Kasraie', 'Affiliation': 'Department of Radiology, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ryan K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Einstein Healthcare Network, New York, New York.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Neill', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Anokh', 'Initials': 'A', 'LastName': 'Pahwa', 'Affiliation': 'Department of Radiology Sciences, Olive View UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Pavlina', 'Initials': 'P', 'LastName': 'Pike', 'Affiliation': 'Huntsville Hospital System, Huntsville, Alabama.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Roehm', 'Affiliation': 'Center for Diagnostic Imaging, St Louis Park, Minnesota.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schindera', 'Affiliation': 'Department of Radiology, Cantonal Hospital, Aarau, Aarau, Switzerland.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Starkey', 'Affiliation': ""St Luke's International Hospital, Chuo, Tokyo, Japan.""}, {'ForeName': 'Saravanabavaan', 'Initials': 'S', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Diagnostic and Interventional Radiology and Neuroradiology, University Hospital, Essen, Germany.'}, {'ForeName': 'Cécile R L P N', 'Initials': 'CRLPN', 'LastName': 'Jeukens', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Miglioretti', 'Affiliation': 'Division of Biostatistics, Department of Public Health Sciences, University of California Davis School of Medicine, Davis.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0064']
377,32227157,Effect of In-Hospital Remote Ischemic Perconditioning on Brain Infarction Growth and Clinical Outcomes in Patients With Acute Ischemic Stroke: The RESCUE BRAIN Randomized Clinical Trial.,"Importance


Treatment with remote ischemic perconditioning has been reported to reduce brain infarction volume in animal models of stroke. Whether this neuroprotective effect was observed in patients with acute ischemic stroke remains unknown.
Objective


To determine whether treatment with remote ischemic perconditioning administered to the leg of patients with acute ischemic stroke can reduce brain infarction volume growth.
Design, Setting, and Participants


This proof-of-concept multicenter prospective randomized open-label with blinded end point clinical trial was performed from January 12, 2015, to May 2, 2018. Patients were recruited from 11 stroke centers in France. Of the 188 patients who received magnetic resonance imaging within 6 hours of symptom onset and were confirmed to have carotid ischemic stroke, 93 were randomized to receive treatment with lower-limb remote ischemic perconditioning in addition to standard care (the intervention group), and 95 were randomized to receive standard care alone (the control group).
Interventions


Randomization on a 1:1 ratio to receive treatment with remote ischemic perconditioning (4 cycles of 5-minute inflations and 5-minute deflations to the thigh to 110 mm Hg above systolic blood pressure) in addition to standard care or standard care alone.
Main Outcomes and Measures


The change in brain infarction volume growth between baseline and 24 hours, measured by a diffusion-weighted sequence of magnetic resonance imaging scans of the brain.
Results


A total of 188 patients (mean [SD] age, 67.2 [15.7] years; 98 men [52.1%]) were included in this intention-to-treat analysis. At hospital admission, the median National Institutes of Health Stroke Scale score was 10 (interquartile range [IQR], 6-16) and the median brain infarction volume was 11.4 cm3 (IQR, 3.6-35.8 cm3); 164 patients (87.2%) received intravenous thrombolysis, and 64 patients (34.0%) underwent mechanical thrombectomy. The median increase in brain infarction growth was 0.30 cm3 (IQR, 0.11-0.48 cm3) in the intervention group and 0.37 cm3 (IQR, 0.19-0.55 cm3) in the control group (mean between-group difference on loge-transformed change, -0.07; 95% CI, -0.33 to 0.18; P = .57). An excellent outcome (defined as a score of 0-1 on the 90-day modified Rankin Scale or a score equal to the prestroke modified Rankin Scale score) was observed in 46 of 90 patients (51.1%) in the intervention group and 37 of 91 patients (40.7%) in the control group (P = .12). No significant differences in 90-day mortality were observed between the intervention and control groups (14 of 90 patients; Kaplan-Meier estimate, 15.8% vs 10 of 91 patients; Kaplan-Meier estimate, 10.4%, respectively; P = .45) or with symptomatic intracerebral hemorrhage (4 of 88 patients [4.5%] in both groups; P = .97).
Conclusions and Relevance


In this study, treatment with remote ischemic perconditioning, during or after reperfusion therapies, had no significant effect on brain infarction volume growth at 24 hours after symptom onset.
Trial Registration


ClinicalTrials.gov Identifier: NCT02189928.",2020,"No significant differences in 90-day mortality were observed between the intervention and control groups (14 of 90 patients; Kaplan-Meier estimate, 15.8% vs 10 of 91 patients; Kaplan-Meier estimate, 10.4%, respectively; P = .45) or with symptomatic intracerebral hemorrhage (4 of 88 patients [4.5%] in both groups; P = .97).
","['patients with acute ischemic stroke', 'Patients With Acute Ischemic Stroke', 'January 12, 2015, to May 2, 2018', ' 98 men [52.1%]) were included in this intention-to-treat analysis', '188 patients who received', '188 patients (mean [SD] age, 67.2 [15.7] years', 'Patients were recruited from 11 stroke centers in France']","['magnetic resonance imaging', 'Hospital Remote Ischemic Perconditioning', 'standard care alone (the control group', 'lower-limb remote ischemic perconditioning in addition to standard care', 'standard care or standard care alone', 'remote ischemic perconditioning', 'remote ischemic perconditioning (4 cycles of 5-minute inflations and 5-minute deflations to the thigh to 110 mm']","['brain infarction volume growth', 'brain infarction growth', 'carotid ischemic stroke', 'Brain Infarction Growth and Clinical Outcomes', 'Hg above systolic blood pressure', 'median brain infarction volume', '90-day modified Rankin Scale or a score equal to the prestroke modified Rankin Scale score', '90-day mortality', 'median National Institutes of Health Stroke Scale score', 'symptomatic intracerebral hemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}]","[{'cui': 'C0751955', 'cui_str': 'Brain Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}]",188.0,0.120086,"No significant differences in 90-day mortality were observed between the intervention and control groups (14 of 90 patients; Kaplan-Meier estimate, 15.8% vs 10 of 91 patients; Kaplan-Meier estimate, 10.4%, respectively; P = .45) or with symptomatic intracerebral hemorrhage (4 of 88 patients [4.5%] in both groups; P = .97).
","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pico', 'Affiliation': 'Department of Neurology and Stroke Center, Versailles Mignot Hospital, Versailles, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'University of Versailles Saint-Quentin-en-Yvelines and Paris-Saclay University, Saint-Aubin, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrigno', 'Affiliation': 'Department of Degenerative and Vascular Cognitive Disorders, Inserm U1171, Université de Lille, Lille, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Rosso', 'Affiliation': 'Assistance Publique-Hopitaux de Paris, Service des Urgences Cerebro-Vasculaires, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Meseguer', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Neurology and Stroke Center, Bichat University Hospital, Universite Paris Diderot, Sorbonne Cite, Paris, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Chadenat', 'Affiliation': 'Department of Neurology and Stroke Center, Versailles Mignot Hospital, Versailles, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Bourdain', 'Affiliation': 'Neurology and Stroke Center, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Obadia', 'Affiliation': 'Neurology and Stroke Center, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hirel', 'Affiliation': 'Department of Neurology and Stroke Center, Versailles Mignot Hospital, Versailles, France.'}, {'ForeName': 'Duc Long', 'Initials': 'DL', 'LastName': 'Duong', 'Affiliation': 'Department of Neurology and Stroke Center, Versailles Mignot Hospital, Versailles, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Assistance Publique-Hopitaux de Paris, Service des Urgences Cerebro-Vasculaires, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Aegerter', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Vieillissement et Maladies Chroniques, IndianaSERM, Unité Mixte de Recherche 1168, Universite de Versailles Saint-Quentin-en-Yvelines, Versailles, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Unité de Recherche EA 2694-Sante Publique: Epidemiologie et Qualite des Soins, Centre Hospitalier Universitaire de Lille, Lille, France.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Cattenoy', 'Affiliation': 'Délégation à la Recherche Clinique, Versailles Mignot Hospital, Versailles, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Smadja', 'Affiliation': 'Stroke Unit, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Assistance Publique-Hopitaux de Paris, Stroke Center, Henri Mondor Hospital, Université Paris-Est Créteil, Creteil, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guillon', 'Affiliation': 'Department of Neurology, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Wolff', 'Affiliation': 'Stroke Unit, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Samson', 'Affiliation': 'Assistance Publique-Hopitaux de Paris, Service des Urgences Cerebro-Vasculaires, Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cordonnier', 'Affiliation': 'Department of Degenerative and Vascular Cognitive Disorders, Inserm U1171, Université de Lille, Lille, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Laboratoire de Recherche Vasculaire Translationnelle, Inserm U1148, Paris, France.'}]",JAMA neurology,['10.1001/jamaneurol.2020.0326']
378,32068436,"Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial.","Background:  SAR341402 (SAR-Asp) is a biosimilar/follow-on of the originator insulin aspart-NovoLog ® /NovoRapid ®  (NN-Asp). This study investigated whether the efficacy, safety, and immunogenicity findings for SAR-Asp versus NN-Asp, observed over 6 months in people with type 1 ( n  = 497) or type 2 diabetes ( n  = 100) treated with multiple daily injections in combination with insulin glargine (Lantus ® ), are maintained after 12 months.  Materials and Methods:  GEMELLI 1 was a multicenter, randomized, open-label, phase 3 study. Participants completing the initial 6-month treatment period continued on SAR-Asp or NN-Asp, as randomized, for a 6-month safety extension.  Results:  Of the 597 participants randomized, 264 out of 301 (87.7%) and 263 out of 296 (88.9%) assigned to SAR-Asp and NN-Asp, respectively, completed 12 months of treatment. Improved glycemic control was sustained at 12 months in both treatment groups, with similar least-squares mean reductions in glycated hemoglobin (HbA1c) from baseline (SAR-Asp: -0.25%; NN-Asp: -0.26%). Fasting plasma glucose and seven-point self-monitored plasma glucose profile changes, including postprandial glucose excursions, and changes in mealtime and basal insulin dosages were similar between groups. Safety and tolerability, including anti-insulin aspart antibodies (AIAs; incidence, prevalence, titers, cross-reactivity to human insulin), neutralizing antibodies (incidence, prevalence), hypoglycemia, and treatment-emergent adverse events (including hypersensitivity events and injection site reactions), were similar between groups. No relationship was observed between maximum individual AIA titers and change in HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions or between efficacy/safety measures and subgroups by presence or absence of treatment-emergent AIA.  Conclusions:  SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months of treatment.",2020,SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment.,"['people with type 1 (T1D, n=497) or type 2 diabetes (T2D, n=100) treated with', 'people with diabetes over 12 months treatment', 'People with Diabetes also Using Insulin Glargine']","['Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart', 'multiple daily injections in combination with insulin glargine (Lantus®']","['maximum individual AIA titers and change in HbA1c or insulin dose, hypoglycemia, or hypersensitivity reactions', 'glycemic control', 'Safety and tolerability, including anti-insulin aspart antibodies (AIA; incidence, prevalence, titers, cross-reactivity to human insulin), neutralizing antibodies (incidence, prevalence), hypoglycemia, treatment-emergent adverse events (including hypersensitivity events and injection site reactions', 'efficacy and safety (including immunogenicity', 'Fasting plasma glucose and seven-point self-monitored plasma glucose profile changes, including postprandial glucose excursions, and changes in mealtime and basal insulin dosages']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0876064', 'cui_str': 'Lantus'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",597.0,0.0510182,SAR-Asp and NN-Asp demonstrated similar efficacy and safety (including immunogenicity) in people with diabetes over 12 months treatment.,"[{'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Wernicke-Panten', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Wardecki', 'Affiliation': 'Sanofi, Warszawa, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kramer', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Delalande', 'Affiliation': 'Ividata, Paris, France.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Franek', 'Affiliation': 'Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warszawa, Poland.'}, {'ForeName': 'Karita', 'Initials': 'K', 'LastName': 'Sadeharju', 'Affiliation': 'Terveystalo Seinäjoki, Seinäjoki, Finland.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Monchamp', 'Affiliation': 'Endocrinology Services Northwest, Bend, Oregon.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Miossec', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0008']
379,31738372,Minocycline at 2 Different Dosages vs Placebo for Patients With Mild Alzheimer Disease: A Randomized Clinical Trial.,"Importance


There are no disease-modifying treatments for Alzheimer disease (AD), the most common cause of dementia. Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
Objective


To determine whether 24 months of minocycline treatment can modify cognitive and functional decline in patients with mild AD.
Design, Setting, and Participants


Participants were recruited into a double-blind randomized clinical trial from May 23, 2014, to April 14, 2016, with 24 months of treatment and follow-up. This multicenter study in England and Scotland involved 32 National Health Service memory clinics within secondary specialist services for people with dementia. From 886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized.
Interventions


Participants were randomly allocated 1:1:1 in a semifactorial design to receive minocycline (400 mg/d or 200 mg/d) or placebo for 24 months.
Main Outcomes and Measures


Primary outcome measures were decrease in sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression.
Results


Of 544 eligible participants (241 women and 303 men), the mean (SD) age was 74.3 (8.2) years, and the mean (SD) sMMSE score was 26.4 (1.9). Fewer participants completed 400-mg minocycline hydrochloride treatment (28.8% [53 of 184]) than 200-mg minocycline treatment (61.9% [112 of 181]) or placebo (63.7% [114 of 179]; P < .001), mainly because of gastrointestinal symptoms (42 in the 400-mg group, 15 in the 200-mg group, and 10 in the placebo group; P < .001), dermatologic adverse effects (10 in the 400-mg group, 5 in the 200-mg group, and 1 in the placebo group; P = .02), and dizziness (14 in the 400-mg group, 3 in the 200-mg group, and 1 in the placebo group; P = .01). Assessment rates were lower in the 400-mg group: 68.4% (119 of 174 expected) for sMMSE at 24 months compared with 81.8% (144 of 176) for the 200-mg group and 83.8% (140 of 167) for the placebo group. Decrease in sMMSE scores over 24 months in the combined minocycline group was similar to that in the placebo group (4.1 vs 4.3 points). The combined minocycline group had mean sMMSE scores 0.1 points higher than the placebo group (95% CI, -1.1 to 1.2; P = .90). The decrease in mean sMMSE scores was less in the 400-mg group than in the 200-mg group (3.3 vs 4.7 points; treatment effect = 1.2; 95% CI, -0.1 to 2.5; P = .08). Worsening of BADLS scores over 24 months was similar in all groups: 5.7 in the 400-mg group, 6.6 in the 200-mg group, and 6.2 in the placebo groups (treatment effect for minocycline vs placebo = -0.53; 95% CI, -2.4 to 1.3; P = .57; treatment effect for 400 mg vs 200 mg of minocycline = -0.31; 95% CI, -0.2 to 1.8; P = .77). Results were similar in different patient subgroups and in sensitivity analyses adjusting for missing data.
Conclusions and Relevance


Minocycline did not delay the progress of cognitive or functional impairment in people with mild AD during a 2-year period. This study also found that 400 mg of minocycline is poorly tolerated in this population.
Trial Registration


isrctn.org Identifier: ISRCTN16105064.",2020,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","['544 eligible participants (241 women and 303 men', 'patients with mild AD', 'Patients With Mild Alzheimer Disease', '32 National Health Service memory clinics within secondary specialist services for people with dementia', '886 screened patients, 554 patients with a diagnosis of mild AD (Standardised Mini-Mental State Examination [sMMSE] score ≥24) were randomized']","['Placebo', 'minocycline hydrochloride', 'placebo', 'minocycline', 'Minocycline']","['Assessment rates', 'gastrointestinal symptoms', 'sMMSE scores', 'dermatologic adverse effects', 'cognitive and functional decline', 'Worsening of BADLS scores', 'mean sMMSE scores', 'sMMSE score and Bristol Activities of Daily Living Scale (BADLS), analyzed by intention-to-treat repeated-measures regression', 'mean (SD) sMMSE score', 'dizziness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026186', 'cui_str': 'Minocycline Hydrochloride'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",554.0,0.722529,"Minocycline is anti-inflammatory, protects against the toxic effects of β-amyloid in vitro and in animal models of AD, and is a credible repurposed treatment candidate.
","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Howard', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Zubko', 'Affiliation': ""Old Age Psychiatry, King's College London, London, United Kingdom.""}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Bradley', 'Affiliation': 'Medical Research Council Population Health Research Unit, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Harper', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Pank', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Tabet', 'Affiliation': 'Department of Old Age Psychiatry, University of Sussex, Brighton, United Kingdom.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'Birmingham and Solihull Mental Health National Health Service Foundation Trust, Birmingham, United Kingdom.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'McShane', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Department of Old Age Psychiatry, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Ritchie', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Reeves', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lovestone', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'Medical School, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Noble', 'Affiliation': ""Department of Basic and Clinical Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Nilforooshan', 'Affiliation': 'Surrey and Borders Partnership National Health Service Foundation Trust, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Wilcock', 'Affiliation': 'Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.3762']
380,30478937,"DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home.","AIMS


Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes.
METHODS


This was a prospective, multicentre, crossover, controlled study (clinicaltrials.gov NCT01238406). All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System. In the intervention arm only, the amount of carbohydrate was entered into the bolus calculator; the rest of insulin delivery was automated and wireless via a tablet computer. The primary endpoint was percentage of glucose values between 70 and 180 mg/dL.
RESULTS


The ITT population comprised 48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age, 16.1years [13.2-18.5]; diabetes duration, 9.4 years [5.0-12.7]; pump use, 5.4 years [3.1-9.4]; HbA1c, 7.6% [7.0-8.1]. A significant increase in the percentage of time within target range (70-180 mg/dL) (66.6% vs 59.9%, P = 0.002) was observed with the closed-loop system vs control weekends with unchanged percentage of time below 70 mg/dL (2.3% vs 1.5%, P = 0.369). Mean weekend glucose level per participant was significantly lower (153 [142-175] vs 164 [150-186] mg/dL, P = 0.003). No safety signals were observed.
CONCLUSIONS


The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use. The absence of remote monitoring did not lead to safety signals in adapting basal rates nor in administration of automated bolus corrections.",2019,The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use.,"['patients with type 1 diabetes at home', 'participants with type 1 diabetes', '48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age, 16.1years [13.2-18.5]; diabetes duration, 9.4 years [5.0-12.7]; pump use, 5.4 years [3.1-9.4]; HbA1c, 7.6% [7.0-8.1']","['SAP therapy or the MD-Logic System', 'DREAM5', 'day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy', 'sensor-augmented pump (SAP) therapy', 'CE marked MD-Logic closed-loop system (DreaMed GlucoSitter']","['Mean weekend glucose level per participant', 'percentage of glucose values', 'safety and efficacy', 'percentage of time within target range']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0023963', 'cui_str': 'Logic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0013117', 'cui_str': 'Dreams'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",,0.048158,The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use.,"[{'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Children\'s Hospital ""Auf der Bult,"" Diabetes-Center for Children and Adolescents, Hannover, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Nir', 'Affiliation': ""Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Remus', 'Affiliation': 'Children\'s Hospital ""Auf der Bult,"" Diabetes-Center for Children and Adolescents, Hannover, Germany.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Farfel', 'Affiliation': ""Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Muller', 'Affiliation': 'DreaMed Diabetes Ltd, Petah Tikvah, Israel.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Biester', 'Affiliation': 'Children\'s Hospital ""Auf der Bult,"" Diabetes-Center for Children and Adolescents, Hannover, Germany.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Atlas', 'Affiliation': 'DreaMed Diabetes Ltd, Petah Tikvah, Israel.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, UMC Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Nataša', 'Initials': 'N', 'LastName': 'Bratina', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, UMC Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Children\'s Hospital ""Auf der Bult,"" Diabetes-Center for Children and Adolescents, Hannover, Germany.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, UMC Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Philip', 'Affiliation': ""Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Children\'s Hospital ""Auf der Bult,"" Diabetes-Center for Children and Adolescents, Hannover, Germany.'}, {'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13585']
381,30537180,"A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).","AIM


To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D).
MATERIALS AND METHODS


This was a double-blind, treat-to-target, randomized, 16-week trial investigating CSII treatment with faster aspart (n = 236) or IAsp (n = 236). All available information, regardless of treatment discontinuation, was used for the evaluation of effect.
RESULTS


Faster aspart was non-inferior to IAsp regarding the change from baseline in glycated haemoglobin (HbA1c; primary endpoint). The mean HbA1c changed from 58.4 mmol/mol (7.5%) at baseline to 57.8 mmol/mol (7.4%) with faster aspart and to 56.8 mmol/mol (7.4%) with IAsp after 16 weeks' treatment, with an estimated treatment difference (ETD) of 1.0 mmol/mol (95% confidence interval [CI] 0.14; 1.87) or 0.09% (95% CI 0.01; 0.17; P < 0.001) for non-inferiority (0.4% margin; P < 0.02 for statistical significance in favour of IAsp). Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/dL [95% CI -25.7; -7.0]; P = 0.001), with statistically significant reductions also at 30 minutes and 2 hours. The improvement in PPG was reflected in the change from baseline in 1-hour interstitial glucose increment after all meals (ETD -0.21 mmol/L [95% CI -0.31; -0.11] or -3.77 mg/dL [95% CI -5.53; -2.01]). There was no statistically significant difference in the overall rate of severe or blood glucose-confirmed hypoglycaemia (estimated rate ratio 1.00 [95% CI 0.85; 1.16]). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and 4-week run-in periods (4 vs 0).
CONCLUSIONS


Faster aspart provides an effective and safe option for CSII treatment in T1D.",2019,Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/,"['n = 236) or IAsp (n = 236', 'adults with type 1 diabetes (onset 5', 'participants with type 1 diabetes (T1D']","['fast-acting insulin aspart', 'continuous subcutaneous insulin infusion (CSII', 'dL', 'fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp', 'CSII treatment with faster aspart']","['PPG', 'severe hypoglycaemic episodes', 'effective and safe option', 'overall rate of severe or blood glucose-confirmed hypoglycaemia', 'mean HbA1c', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",236.0,0.192883,Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Klonoff', 'Affiliation': 'Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, California.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Evans', 'Affiliation': 'Wellcome Trust/MRC Institute of Metabolic Science and Department of Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lane', 'Affiliation': 'Mountain Diabetes and Endocrine Center, Asheville, North Carolina.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Kempe', 'Affiliation': 'Centre for Diabetes and Nutrition Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Department of Endocrinology, Diabetes, and Nutrition and Clinical Investigation Centre, Montpellier University Hospital, Institute of Functional Genomics, CNRS, INSERM, University of Montpellier, Montpellier, France.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Graungaard', 'Affiliation': 'Novo Nordisk A/S, Aalborg, Denmark.'}, {'ForeName': 'Agon', 'Initials': 'A', 'LastName': 'Hyseni', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Gondolf', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13610']
382,30552787,Nasal insulin administration does not affect hepatic glucose production at systemic fasting insulin levels.,"AIMS


To evaluate the effects of brain insulin on endogenous glucose production in fasting humans, with a focus on hepatic glucose release by performing a randomized, placebo-controlled, blinded, crossover experiment.
MATERIALS AND METHODS


On two separate days,  2  H 2  -glucose was infused to nine healthy lean men, and blood was sampled from the hepatic vein and a radial artery. On day 1, participants received 160 U human insulin through nasal spray, and on day 2 they received placebo spray, together with an intravenous insulin bolus to mimic spillover of nasal insulin to the circulation. Hepatic glucose fluxes and endogenous glucose production were calculated.
RESULTS


Plasma insulin concentrations were similar on the two study days, and no differences in whole-body endogenous glucose production or hepato-splanchnic glucose turnover were detected.
CONCLUSIONS


Nasal administration of insulin does not influence whole-body or hepatic glucose production in fasting humans. By contrast, pharmacological delivery of insulin to the brain might modulate insulin effectiveness in glucose-producing tissue when circulating insulin levels are elevated; therefore, the metabolic consequences of brain insulin action appear to be dependent on metabolic prandial status.",2019,"RESULTS


Plasma insulin concentrations were similar on the two study days, and no differences in whole-body endogenous glucose production or hepato-splanchnic glucose turnover were detected.
",['fasting humans'],"['placebo spray', '160\u2009U human insulin through nasal spray', 'brain insulin', 'placebo']","['whole-body endogenous glucose production or hepato-splanchnic glucose turnover', 'Plasma insulin concentrations', 'hepatic glucose production', 'Hepatic glucose fluxes and endogenous glucose production']","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0795635', 'cui_str': 'insulin (human)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",9.0,0.0353559,"RESULTS


Plasma insulin concentrations were similar on the two study days, and no differences in whole-body endogenous glucose production or hepato-splanchnic glucose turnover were detected.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Plomgaard', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jakob S', 'Initials': 'JS', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bodil', 'Initials': 'B', 'LastName': 'Ingerslev', 'Affiliation': 'Centre of Inflammation and Metabolism, and the Centre for Physical Activity Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens O', 'Initials': 'JO', 'LastName': 'Clemmesen', 'Affiliation': 'Department of Hepatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesiology, Copenhagen Muscle Research Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Department of Biomedical Sciences, Clinical Metabolomics Core Facility, Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fritsche', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases, Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Weigert', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases, Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Lehmann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases, Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Häring', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases, Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heni', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases, Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Center Munich at the University of Tuebingen, Tuebingen, Germany.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13615']
383,30756302,Health Coaching Has Differential Effects on Veterans with Limited Health Literacy and Numeracy: a Secondary Analysis of ACTIVATE.,"BACKGROUND


Health coaching is an effective behavior change strategy. Understanding if there is a differential impact of health coaching on patients with low health literacy has not been well investigated.
OBJECTIVE


To determine whether a telephone coaching intervention would result in similar improvements in enrollment in prevention programs and patient activation among Veterans with low versus high health literacy (specifically, reading literacy and numeracy).
DESIGN


Secondary analysis of a randomized controlled trial.
PARTICIPANTS


Four hundred seventeen Veterans with at least one modifiable risk factor: current smoker, BMI ≥ 30, or < 150 min of moderate physical activity weekly.
METHODS


A single-item assessment of health literacy and a subjective numeracy scale were assessed at baseline. A logistic regression and general linear longitudinal models were used to examine the differential impact of the intervention compared to control on enrollment in prevention programs and changes in patient activation measures (PAM) scores among patients with low versus high health literacy.
RESULTS


The coaching intervention resulted in higher enrollment in prevention programs and improvements in PAM scores compared to usual care regardless of baseline health literacy. The coaching intervention had a greater effect on the probability of enrollment in prevention programs for patients with low numeracy (intervention vs control difference of 0.31, 95% CI 0.18, 0.45) as compared to those with high numeracy (0.13, 95% CI - 0.01, 0.27); the low compared to high differential effect was clinically, but not statistically significant (0.18, 95% CI - 0.01, 0.38; p = 0.07). Among patients with high numeracy, the intervention group had greater increases in PAM as compared to the control group at 6 months (mean difference in improvement 4.8; 95% CI 1.7, 7.9; p = 0.003). This led to a clinically and statistically significant differential intervention effect for low vs high numeracy (- 4.6; 95% CI - 9.1, - 0.15; p = 0.04).
CONCLUSIONS


We suggest that health coaching may be particularly beneficial in behavior change strategies in populations with low numeracy when interpretation of health risk information is part of the intervention. CLINICALTRIALS.
GOV IDENTIFIER


NCT01828567.",2019,The coaching intervention resulted in higher enrollment in prevention programs and improvements in PAM scores compared to usual care regardless of baseline health literacy.,"['Four hundred seventeen Veterans with at least one modifiable risk factor: current smoker, BMI\u2009≥\u200930, or <\u2009150\xa0min of moderate physical activity weekly', 'Veterans with low versus high health literacy (specifically, reading literacy and numeracy', 'patients with low versus high health literacy', 'Veterans with Limited Health Literacy and Numeracy', 'patients with low health literacy']","['coaching intervention', 'health coaching', 'Health Coaching', 'telephone coaching intervention']","['probability of enrollment in prevention programs', 'PAM', 'health literacy and a subjective numeracy scale', 'PAM scores', 'patient activation measures (PAM) scores']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C3241966'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4075848', 'cui_str': 'Patient Activation Measure score'}]",417.0,0.0887536,The coaching intervention resulted in higher enrollment in prevention programs and improvements in PAM scores compared to usual care regardless of baseline health literacy.,"[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Nouri', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, CA, USA. sarah.nouri@ucsf.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Damschroder', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gierisch', 'Affiliation': 'VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Fagerlin', 'Affiliation': 'Salt Lake City VA Informatics Decision-Enhancement and Analytic Sciences (IDEAS 2.0) Center for Innovation, Salt Lake City, UT, USA.'}, {'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Sanders', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'McCant', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham VA Health Care System, Durham, NC, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Duke University Medical Center, Durham, NC, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04861-7']
384,32219407,The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial.,"Importance


Surgical site infections increase patient morbidity and health care costs. The Centers for Disease Control and Prevention emphasize improved basic preventive measures to reduce bacterial transmission and infections among patients undergoing surgery.
Objective


To assess whether improved basic preventive measures can reduce perioperative Staphylococcus aureus transmission and surgical site infections.
Design, Setting, and Participants


This randomized clinical trial was conducted from September 20, 2018, to September 20, 2019, among 19 surgeons and their 236 associated patients at a major academic medical center with a 60-day follow-up period. Participants were a random sample of adult patients undergoing orthopedic total joint, orthopedic spine, oncologic gynecological, thoracic, general, colorectal, open vascular, plastic, or open urological surgery requiring general or regional anesthesia. Surgeons and their associated patients were randomized 1:1 via a random number generator to treatment group or to usual care. Observers were masked to patient groupings during assessment of outcome measures.
Interventions


Sustained improvements in perioperative hand hygiene, vascular care, environmental cleaning, and patient decolonization efforts.
Main Outcomes and Measures


Perioperative S aureus transmission assessed by the number of isolates transmitted and the incidence of transmission among patient care units (primary) and the incidence of surgical site infections (secondary).
Results


Of 236 patients (156 [66.1%] women; mean [SD] age, 57 [15] years), 106 (44.9%) and 130 (55.1%) were allocated to the treatment and control groups, respectively, received the intended treatment, and were analyzed for the primary outcome. Compared with the control group, the treatment group had a reduced mean (SD) number of transmitted perioperative S aureus isolates (1.25 [2.11] vs 0.47 [1.13]; P = .002). Treatment reduced the incidence of S aureus transmission (incidence risk ratio; 0.56; 95% CI, 0.37-0.86; P = .008; with robust variance clustering by surgeon: 95% CI, 0.42-0.76; P < .001). Overall, 11 patients (4.7%) experienced surgical site infections, 10 (7.7%) in the control group and 1 (0.9%) in the treatment group. Transmission was associated with an increased risk of surgical site infection (8 of 73 patients [11.0%] with transmission vs 3 of 163 [1.8%] without; risk ratio, 5.95; 95% CI, 1.62-21.86; P = .007). Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004).
Conclusions and Relevance


Improved basic preventive measures in the perioperative arena can reduce S aureus transmission and surgical site infections.
Trial Registration


ClinicalTrials.gov Identifier: NCT03638947.",2020,"Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004).
","['September 20, 2018, to September 20, 2019, among 19 surgeons and their 236 associated patients at a major academic medical center with a 60-day follow-up period', 'Participants were a random sample of adult patients undergoing orthopedic total joint, orthopedic spine, oncologic gynecological, thoracic, general, colorectal, open vascular, plastic, or open urological surgery requiring general or regional anesthesia', 'patients undergoing surgery', 'Staphylococcus aureus Transmission and Surgical Site Infections', '236 patients (156 [66.1%] women; mean [SD] age, 57 [15] years), 106 (44.9%) and']",['random number generator to treatment group or to usual care'],"['risk of surgical site infection', 'incidence of S aureus transmission', 'reduced mean (SD) number of transmitted perioperative S aureus isolates', 'perioperative hand hygiene, vascular care, environmental cleaning, and patient decolonization efforts', 'patient morbidity and health care costs', 'Measures\n\n\nPerioperative S aureus transmission assessed by the number of isolates transmitted and the incidence of transmission among patient care units (primary) and the incidence of surgical site infections (secondary', 'surgical site infections']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0032167', 'cui_str': 'Plastics'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0017313'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",236.0,0.221262,"Treatment reduced the risk of surgical site infection (hazard ratio, 0.12; 95% CI, 0.02-0.92; P = .04; with clustering by surgeon: 95% CI, 0.03-0.51; P = .004).
","[{'ForeName': 'Randy W', 'Initials': 'RW', 'LastName': 'Loftus', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Franklin', 'Initials': 'F', 'LastName': 'Dexter', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Goodheart', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keech', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Noiseux', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pugely', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Sharafuddin', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'W Thomas', 'Initials': 'WT', 'LastName': 'Lawrence', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGonagill', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Shanklin', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Dionne', 'Initials': 'D', 'LastName': 'Skeete', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Tracy', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Erickson', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Granchi', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Godding', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Raven', 'Initials': 'R', 'LastName': 'Brenneke', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Persons', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Herber', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Yeager', 'Affiliation': 'Department of Anesthesia, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hadder', 'Affiliation': 'Department of Anesthesia, University of Iowa, Iowa City.'}, {'ForeName': 'Jeremiah R', 'Initials': 'JR', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1934']
385,30593908,Factors That Hinder and Facilitate Cancer Patients' Knowledge About Pain Management-A Qualitative Study.,"CONTEXT


Pain management education may improve pain control for some patients, whereas individual differences exist.
OBJECTIVES


To evaluate possible critical components, facilitators, and hindrances for improved knowledge about pain management, in not hospitalized adult oncology patients with pain from bone metastasis participating in a pain management intervention.
METHODS


This substudy is a qualitative evaluation of the PRO-SELF Pain Control Program, tested in a randomized controlled trial. During six weeks, 87 participants in the intervention group received tailored coaching encounters by a trained oncology nurse. Three encounters for each patient were audio recorded. The encounter between patient's with the largest (n = 12) and lowest (n = 8) change in knowledge about pain management from before to after the intervention was transcribed verbatim and analyzed with qualitative content analysis.
RESULTS


The critical components of the intervention were repetition of information, struggling with resistance, use of peer experiences, and keeping track of variations. Facilitators of improvement were patients' trust and preparedness to try new procedures, the patient's self-awareness and body awareness, and taking active role in own care. Difficulties in processing complex information, culturally conditioned behaviors, fear, and lack of knowledge were the most important barriers to the success of the intervention.
CONCLUSION


Education in pain management in cancer patients requires repeated information, allowing time for overcoming resistance related to dysfunctional beliefs and fear. To facilitate the patient's involvement in their pain management, tailored and person-centered education is needed.",2019,"Facilitators of improvement were patients' trust and preparedness to try new procedures, the patient's self-awareness and body awareness, and taking active role in own care.","['hospitalized adult oncology patients with pain from bone metastasis participating in a pain management intervention', 'cancer patients']","['tailored coaching encounters by a trained oncology nurse', 'PRO-SELF Pain Control Program']","['pain control', 'knowledge about pain management', 'repetition of information, struggling with resistance, use of peer experiences']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0557529', 'cui_str': 'Oncology nurse (occupation)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",87.0,0.0393982,"Facilitators of improvement were patients' trust and preparedness to try new procedures, the patient's self-awareness and body awareness, and taking active role in own care.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Ekstedt', 'Affiliation': 'Faculty of Health and Life Sciences, Linnaeus University, Kalmar, Sweden; Medical Management Centre, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Rustøen', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway; Department of Nursing Science, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: tone.rustoen@medisin.uio.no.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2018.12.334']
386,30639758,"An Individualized, Interactive Intervention Promotes Terminally Ill Cancer Patients' Prognostic Awareness and Reduces Cardiopulmonary Resuscitation Received in the Last Month of Life: Secondary Analysis of a Randomized Clinical Trial.","CONTEXT/OBJECTIVE


Half of advanced cancer patients do not have accurate prognostic awareness (PA). However, few randomized clinical trials (RCTs) have focused on facilitating patients' PA to reduce their life-sustaining treatments at end of life (EOL). To address these issues, we conducted a double-blinded RCT on terminally ill cancer patients.
METHODS


Experimental-arm participants received an individualized, interactive intervention tailored to their readiness for advanced care planning and prognostic information. Control-arm participants received a symptom-management educational treatment. Effectiveness of our intervention in facilitating accurate PA and reducing life-sustaining treatments received, two secondary RCT outcomes, was evaluated by intention-to-treat analysis using multivariate logistic regression.
RESULTS


Participants (N = 460) were randomly assigned 1:1 to experimental and control arms, each with 215 participants in the final sample. Referring to 151-180 days before death, experimental-arm participants had significantly higher odds of accurate PA than control-arm participants 61-90, 91-120, and 121-150 days before death (adjusted odds ratio [95% CI]: 2.04 [1.16-3.61], 1.94 [1.09-3.45], and 1.93 [1.16-3.21], respectively), but not one to 60 days before death. Experimental-arm participants with accurate PA were significantly less likely than control-arm participants without accurate PA to receive cardiopulmonary resuscitation (CPR) (0.16 [0.03-0.73]), but not less likely to receive intensive care unit care and mechanical ventilation in their last month.
CONCLUSION


Our intervention facilitated cancer patients' accurate PA early in their dying trajectory, reducing the risk of receiving CPR in the last month. Health care professionals should cultivate cancer patients' accurate PA early in the terminal-illness trajectory to allow them sufficient time to make informed EOL-care decisions to reduce CPR at EOL.",2019,"Experimental-arm participants with accurate PA were significantly less likely than control-arm participants without accurate PA to receive cardiopulmonary resuscitation (CPR) (0.16 [0.03-0.73]), but not less likely to receive intensive care unit care and mechanical ventilation in their last month.
","['advanced cancer patients', ""Ill Cancer Patients' Prognostic Awareness and Reduces Cardiopulmonary Resuscitation Received in the Last Month of Life"", 'Participants (N\xa0=\xa0460', 'terminally ill cancer patients']","['symptom-management educational treatment', 'individualized, interactive intervention tailored to their readiness for advanced care planning and prognostic information']",['accurate PA'],"[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}]","[{'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}]",460.0,0.0856649,"Experimental-arm participants with accurate PA were significantly less likely than control-arm participants without accurate PA to receive cardiopulmonary resuscitation (CPR) (0.16 [0.03-0.73]), but not less likely to receive intensive care unit care and mechanical ventilation in their last month.
","[{'ForeName': 'Chen Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'College of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Jen-Shi', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Fur-Hsing', 'Initials': 'FH', 'LastName': 'Wen', 'Affiliation': 'Department of International Business, Soochow University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Chou', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Chia-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Ming-Mo', 'Initials': 'MM', 'LastName': 'Hou', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan.'}, {'ForeName': 'Siew Tzuh', 'Initials': 'ST', 'LastName': 'Tang', 'Affiliation': 'Division of Hematology-Oncology, Chang Gung Memorial Hospital, Tao-Yuan, Taiwan. Electronic address: sttang@mail.cgu.edu.tw.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.01.002']
387,32215577,Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial.,"Importance


Complete metastatic ablation of oligometastatic prostate cancer may provide an alternative to early initiation of androgen deprivation therapy (ADT).
Objective


To determine if stereotactic ablative radiotherapy (SABR) improves oncologic outcomes in men with oligometastatic prostate cancer.
Design, Setting, and Participants


The Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer (ORIOLE) phase 2 randomized study accrued participants from 3 US radiation treatment facilities affiliated with a university hospital from May 2016 to March 2018 with a data cutoff date of May 20, 2019, for analysis. Of 80 men screened, 54 men with recurrent hormone-sensitive prostate cancer and 1 to 3 metastases detectable by conventional imaging who had not received ADT within 6 months of enrollment or 3 or more years total were randomized.
Interventions


Patients were randomized in a 2:1 ratio to receive SABR or observation.
Main Outcomes and Measures


The primary outcome was progression at 6 months by prostate-specific antigen level increase, progression detected by conventional imaging, symptomatic progression, ADT initiation for any reason, or death. Predefined secondary outcomes were toxic effects of SABR, local control at 6 months with SABR, progression-free survival, Brief Pain Inventory (Short Form)-measured quality of life, and concordance between conventional imaging and prostate-specific membrane antigen (PSMA)-targeted positron emission tomography in the identification of metastatic disease.
Results


In the 54 men randomized, the median (range) age was 68 (61-70) years for patients allocated to SABR and 68 (64-76) years for those allocated to observation. Progression at 6 months occurred in 7 of 36 patients (19%) receiving SABR and 11 of 18 patients (61%) undergoing observation (P = .005). Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002). Total consolidation of PSMA radiotracer-avid disease decreased the risk of new lesions at 6 months (16% vs 63%; P = .006). No toxic effects of grade 3 or greater were observed. T-cell receptor sequencing identified significant increased clonotypic expansion following SABR and correlation between baseline clonality and progression with SABR only (0.082085 vs 0.026051; P = .03).
Conclusions and Relevance


Treatment with SABR for oligometastatic prostate cancer improved outcomes and was enhanced by total consolidation of disease identified by PSMA-targeted positron emission tomography. SABR induced a systemic immune response, and baseline immune phenotype and tumor mutation status may predict the benefit from SABR. These results underline the importance of prospective randomized investigation of the oligometastatic state with integrated imaging and biological correlates.
Trial Registration


ClinicalTrials.gov Identifier: NCT02680587.",2020,"Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002).","['Oligometastatic Prostate Cancer', '54 men randomized, the median (range) age was 68 (61-70) years for patients allocated to SABR and 68 (64-76) years for those allocated to observation', '80 men screened, 54 men with recurrent hormone-sensitive prostate cancer and 1 to 3 metastases detectable by conventional imaging who had not received ADT within 6 months of enrollment or 3 or more years total were randomized', 'men with oligometastatic prostate cancer', 'Oligometastatic Prostate Cancer (ORIOLE) phase 2 randomized study accrued participants from 3 US radiation treatment facilities affiliated with a university hospital from May 2016 to March 2018 with a data cutoff date of May 20, 2019, for analysis']","['Observation vs Stereotactic Ablative Radiation', 'stereotactic ablative radiotherapy (SABR', 'conventional imaging and prostate-specific membrane antigen (PSMA)-targeted positron emission tomography', 'SABR or observation', 'androgen deprivation therapy (ADT']","['toxic effects of SABR, local control at 6 months with SABR, progression-free survival, Brief Pain Inventory ', 'median progression-free survival', 'Progression', 'oncologic outcomes', 'clonotypic expansion', 'progression at 6 months by prostate-specific antigen level increase, progression detected by conventional imaging, symptomatic progression, ADT initiation for any reason, or death']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1522449', 'cui_str': 'Radiation Treatment'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1310550', 'cui_str': 'prostate-specific membrane antigen, human'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205478', 'cui_str': 'Oncologic (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",54.0,0.211857,"Treatment with SABR improved median progression-free survival (not reached vs 5.8 months; hazard ratio, 0.30; 95% CI, 0.11-0.81; P = .002).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'William Yue', 'Initials': 'WY', 'LastName': 'Shi', 'Affiliation': 'Stanford Cancer Institute, Department of Radiation Oncology, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Deek', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Radwan', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Lim', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Curtiland', 'Initials': 'C', 'LastName': 'Deville', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Greco', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hailun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Denmeade', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Channing J', 'Initials': 'CJ', 'LastName': 'Paller', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Shirl', 'Initials': 'S', 'LastName': 'Dipasquale', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'DeWeese', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Pienta', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Pomper', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Dicker', 'Affiliation': 'Sidney Kimmel Cancer Center, Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ash A', 'Initials': 'AA', 'LastName': 'Alizadeh', 'Affiliation': 'Stanford Cancer Institute, Division of Oncology, Department of Medicine, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Diehn', 'Affiliation': 'Stanford Cancer Institute, Department of Radiation Oncology, School of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0147']
388,32220283,"Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.","BACKGROUND


The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV.
METHODS


We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in São Paulo, Brazil. We recruited healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded. Step A was designed as a small bridge-study between Butantan-DV and TV003 in DENV-naive participants. In step A, we planned to randomly assign 50 dengue virus (DENV)-naive individuals to receive two doses of Butantan-DV, TV003, or placebo, given 6 months apart. In step B, we planned to randomly assign 250 participants (DENV-naive and DENV-exposed) to receive one dose of Butantan-DV or placebo. Participants were randomly assigned, by computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo. Participants and study staff were unaware of treatment allocation. The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat. The primary immunogenicity outcome was seroconversion rates of the DENV-1-4 serotypes measured 91 days after the first vaccination, analysed in the per-protocol population, which included all participants in step A, and all participants included in step B who completed all study visits with serology sample collection. This trial is registered with ClinicalTrials.gov, NCT01696422.
FINDINGS


Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received placebo. Butantan-DV and TV003 were both immunogenic, well-tolerated, and no serious adverse reactions were observed. In step A, rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4.
INTERPRETATION


Butantan-DV and TV003 were safe and induced robust, balanced neutralising antibody responses against the four DENV serotypes. Efficacy evaluation of the Butantan-DV vaccine is ongoing.
FUNDING


Intramural Research Program US NIH National Institute of Allergy and Infectious Diseases, Brazilian National Bank for Economic and Social Development, Fundação de Amparo à Pesquisa do Estado de São Paulo, and Fundação Butantan.",2020,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","['healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded', 'adults in Brazil', 'Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants']","['placebo', 'Butantan-DV or placebo', 'Butantan-DV, TV003, or placebo', 'tetravalent, live-attenuated dengue vaccine Butantan-DV', 'computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo', 'Butantan-DV vaccine']","['Safety and immunogenicity', 'Viraemia', 'seroconversion to DENV-1', 'frequency of solicited and unsolicited local and systemic adverse reactions', 'seroconversion rates of the DENV-1-4 serotypes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0580278', 'cui_str': '4 serotype'}]",300.0,0.486172,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","[{'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexander Roberto', 'Initials': 'AR', 'LastName': 'Precioso', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil; Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. Electronic address: alexander.precioso@butantan.gov.br.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Thomé', 'Affiliation': 'Preventive Medicine Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia Emília', 'Initials': 'PE', 'LastName': 'Braga', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Tazio', 'Initials': 'T', 'LastName': 'Vanni', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Lúcia M A', 'Initials': 'LMA', 'LastName': 'Campos', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Mondini', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Graça Salomão', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'da Silva', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Heloisa M', 'Initials': 'HM', 'LastName': 'Espinola', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Joane', 'Initials': 'J', 'LastName': 'do Prado Santos', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Cecilia L S', 'Initials': 'CLS', 'LastName': 'Santos', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'Maria do Carmo S T', 'Initials': 'MDCST', 'LastName': 'Timenetsky', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'Miraglia', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Neuza M F', 'Initials': 'NMF', 'LastName': 'Gallina', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weiskopf', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Raphaella', 'Initials': 'R', 'LastName': 'Goulart', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael Tavares', 'Initials': 'RT', 'LastName': 'Salles', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alvino', 'Initials': 'A', 'LastName': 'Maestri', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriana Maluf Elias', 'Initials': 'AME', 'LastName': 'Sallum', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sylvia Costa Lima', 'Initials': 'SCL', 'LastName': 'Farhat', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Neusa K', 'Initials': 'NK', 'LastName': 'Sakita', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana C O A', 'Initials': 'JCOA', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassia G T', 'Initials': 'CGT', 'LastName': 'Silveira', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Priscilla R', 'Initials': 'PR', 'LastName': 'Costa', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isaias', 'Initials': 'I', 'LastName': 'Raw', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Kalil', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30023-2']
389,32149425,Effects of simple active referrals of different intensities on smoking abstinence and smoking cessation services attendance: a cluster-randomized clinical trial.,"BACKGROUND AND AIMS


Proactive brief cessation advice by a lay counsellor combined with a referral to a smoking cessation service (active referral) is effective in increasing service use and quitting in community smokers. We compared the effect of two modified approaches to referrals on the cessation outcomes in community smokers.
DESIGN


Three-arm cluster-randomized trial.
SETTING


General community in Hong Kong.
PARTICIPANTS


Daily cigarette smokers (n = 1163; 77.7% male).
INTERVENTIONS


Participants were randomized to receive on-site active referral (OSR, n = 395), where lay counsellors helped participants make appointments with a smoking cessation service of their choice plus tailored reminders; mobile text messaging referral (TMR, n = 385), where participants were encouraged to use a smoking cessation service via text messages; or brief cessation advice only (control, n = 383).
MEASUREMENTS


The primary outcome was a self-reported 7-day point-prevalence abstinence at 6 months post-treatment initiation. Secondary outcomes included 7-day point-prevalence abstinence at 3 and 18 months, biochemically validated abstinence, smoking reduction and the use of cessation services at 3, 6 and 18 months.
FINDINGS


Using intention-to-treat analysis, the OSR (17.7%) and TMR (17.1%) groups had significantly higher self-reported abstinence than the control (12.0%) group at 6 months [odds ratio (OR) for OSR versus control = 1.58, 95% confidence interval (CI) = 1.06-2.36; OR for TMR versus control = 1.52, 95% CI = 1.01-2.28; both P < 0.05]. The corresponding validated abstinence rates at 6 months were 7.6, 7.8 and 3.9% (OR for TMR versus control = 2.02, 95% CI = 1.07-3.81; OR for TMR versus control = 2.07, 95% CI = 1.10-3.92; both P < 0.05). Self-reported and validated abstinence were similar at 18 months. OSR groups had higher rates of smoking cessation service use than the control group at all follow-ups (all P < 0.001). The smoking reduction rates were similar in continuing smokers.
CONCLUSIONS


Simple active referrals (in person or via text messaging) to smoking cessation services increased abstinence rates among smokers in Hong Kong compared with general brief cessation advice. On-site active referral increased the use of smoking cessation services compared with general brief cessation advice.",2020,OSR groups had higher rates of smoking cessation service use than the control group at all follow-ups (all P < 0.001).,"['community smokers', 'General community in Hong Kong', 'Daily cigarette smokers (n\xa0=\xa01163; 77.7% male']","['site active referral (OSR, n\xa0=\xa0395), where lay counsellors helped participants make appointments with a smoking cessation service of their choice plus tailored reminders; mobile text messaging referral (TMR, n\xa0=\xa0385), where participants were encouraged to use a smoking cessation service via text messages; or brief cessation advice only (control, n\xa0=\xa0383']","['rates of smoking cessation service', 'OSR', 'self-reported 7-day point-prevalence abstinence', 'abstinence rates', 'smoking reduction rates', '7-day point-prevalence abstinence at 3 and 18\xa0months, biochemically validated abstinence, smoking reduction and the use of cessation services', 'TMR', 'smoking abstinence and smoking cessation services attendance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C4517751', 'cui_str': 'Three hundred and eighty-five'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720467', 'cui_str': 'Only'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.162331,OSR groups had higher rates of smoking cessation service use than the control group at all follow-ups (all P < 0.001).,"[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Yi Nam', 'Initials': 'YN', 'LastName': 'Suen', 'Affiliation': 'Department of Psychiatry, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Yongda', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Antonio Cho Sshing', 'Initials': 'ACS', 'LastName': 'Kwong', 'Affiliation': 'Hong Kong Council on Smoking and Health, Pokfulam, Hong Kong.'}, {'ForeName': 'Vienna Wai Yin', 'Initials': 'VWY', 'LastName': 'Lai', 'Affiliation': 'Hong Kong Council on Smoking and Health, Pokfulam, Hong Kong.'}, {'ForeName': 'Sophia Siu Chee', 'Initials': 'SSC', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Tai-Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, the University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, the University of Hong Kong, Pokfulam, Hong Kong.'}]","Addiction (Abingdon, England)",['10.1111/add.15029']
390,31178001,Influence of Methylphenidate on Long-Term Neuropsychological and Everyday Executive Functioning After Traumatic Brain Injury in Children with Secondary Attention Problems.,"OBJECTIVE


To investigate the effects of methylphenidate on long-term executive and neuropsychological functioning in children with attention problems following TBI, as well as the relationship between methylphenidate associated changes in lab-based neuropsychological measures of attentional control, processing speed, and executive functioning and parent- or self-report measures of everyday executive functioning.
METHOD


26 children aged 6-17 years, who were hospitalized for moderate-to-severe blunt head trauma 6 or more months previously, were recruited from a large children's hospital medical center. Participants were randomized into a double-masked, placebo-controlled cross-over clinical trial. Participants completed a comprehensive neuropsychological battery and parent- and self-report ratings of everyday executive functioning at baseline, and at 4 weeks and 8 weeks following upward titration of medication to an optimal dose or while administered a placebo.
RESULTS


Methylphenidate was associated with significant improvements in processing speed, sustained attention, and both lab-based and everyday executive functioning. Significant treatment-by-period interactions were found on a task of sustained attention. Participants who were randomized to the methylphenidate condition for the first treatment period demonstrated random or erratic responding, with slower and more variable response times when given placebo during the second period.
CONCLUSION


Results indicate that methylphenidate treatment is associated with positive outcomes in processing speed, sustained attention, and both lab-based and everyday measures of executive functioning compared to placebo group. Additionally, results suggest sustained attention worsens when discontinuing medication. (JINS, 2019, 25, 740-749).",2019,"RESULTS


Methylphenidate was associated with significant improvements in processing speed, sustained attention, and both lab-based and everyday executive functioning.","['Children with Secondary Attention Problems', 'children with attention problems following TBI', ""26 children aged 6-17 years, who were hospitalized for moderate-to-severe blunt head trauma 6 or more months previously, were recruited from a large children's hospital medical center""]","['methylphenidate', 'Methylphenidate', 'placebo']","['Long-Term Neuropsychological and Everyday Executive Functioning', 'processing speed, sustained attention, and both lab-based and everyday measures of executive functioning', 'processing speed, sustained attention, and both lab-based and everyday executive functioning', 'comprehensive neuropsychological battery and parent- and self-report ratings of everyday executive functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0018674', 'cui_str': 'Head Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery (assessment scale)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",26.0,0.259791,"RESULTS


Methylphenidate was associated with significant improvements in processing speed, sustained attention, and both lab-based and everyday executive functioning.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LeBlond', 'Affiliation': 'Psychology Department, McMicken College of Arts and Sciences, University of Cincinnati, 2600 Clifton Ave, 155 B McMicken Hall, Cincinnati, Ohio, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Smith-Paine', 'Affiliation': 'Psychology Department, McMicken College of Arts and Sciences, University of Cincinnati, 2600 Clifton Ave, 155 B McMicken Hall, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jacqlyn J', 'Initials': 'JJ', 'LastName': 'Riemersma', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, Ohio, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Horn', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, Ohio, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': 'Psychology Department, McMicken College of Arts and Sciences, University of Cincinnati, 2600 Clifton Ave, 155 B McMicken Hall, Cincinnati, Ohio, USA.'}, {'ForeName': 'Brad G', 'Initials': 'BG', 'LastName': 'Kurowski', 'Affiliation': ""Division of Physical Medicine and Rehabilitation, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 4009, Cincinnati, Ohio, USA.""}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000444']
391,31443627,Examination of a Subgroup of Patients With Chronic Low Back Pain Likely to Benefit More From Pilates-Based Exercises Compared to an Educational Booklet.,"OBJECTIVE


To investigate whether 2 previously published classification approaches, the updated treatment-based classification system and a Pilates subgroup defined by a preliminary clinical prediction rule, could identify patients with chronic low back pain who would benefit more from Pilates exercises compared to an educational booklet.
DESIGN


Secondary analysis of a randomized controlled trial.
METHODS


Two hundred twenty-two patients received advice and were randomly allocated to a group that received an educational booklet with no additional treatment (n = 74) or a group that received Pilates-based exercise treatment (n = 148) 2 or 3 times a week. At baseline, using a treatment-based classification system, patients were classified as having a good prognosis (positive movement control) or a poor prognosis. Similarly, using the Pilates clinical prediction rule, patients were classified as having a good prognosis (positive) or a poor prognosis (negative). The analysis was conducted using linear regression models to analyze the interaction between subgroup characteristics and treatment effect size, with changes in pain and disability from baseline to 6 weeks after randomization as dependent variables.
RESULTS


None of the interaction terms for pain and disability were statistically significant. The treatment effect of Pilates versus an educational booklet was similar in all subgroups.
CONCLUSION


The treatment-based classification system and the Pilates clinical prediction rule did not differentiate subgroups of patients with chronic low back pain who were more or less likely to benefit more from Pilates compared to an educational booklet.  J Orthop Sports Phys Ther 2020;50(4):189-197. Epub 23 Aug 2019. doi:10.2519/jospt.2019.8839 .",2020,None of the interaction terms for pain and disability were statistically significant.,"['chronic low back pain (LBP', 'patients with LBP who benefit more from Pilates compared to an educational booklet', '222 patients received advice']",['educational booklet group who did not receive additional treatment (n=74) or a Pilates group'],['pain and disability'],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",222.0,0.123893,None of the interaction terms for pain and disability were statistically significant.,"[{'ForeName': 'Diego Diulgeroglo Vicco', 'Initials': 'DDV', 'LastName': 'Amaral', 'Affiliation': ''}, {'ForeName': 'Gisela Cristiane', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': ''}, {'ForeName': 'Katherinne Ferro Moura', 'Initials': 'KFM', 'LastName': 'Franco', 'Affiliation': ''}, {'ForeName': 'Yuri Rafael', 'Initials': 'YR', 'LastName': 'Dos Santos Franco', 'Affiliation': ''}, {'ForeName': 'Naiane Teixeira', 'Initials': 'NT', 'LastName': 'Bastos De Oliveira', 'Affiliation': ''}, {'ForeName': 'Mark Jonathan', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': ''}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'Van Tulder', 'Affiliation': ''}, {'ForeName': 'Cristina Maria', 'Initials': 'CM', 'LastName': 'Nunes Cabral', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8839']
392,32036406,"Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Pulmonary Function, and Respiratory Muscle Strength After Posterolateral Thoracotomy: A Randomized Controlled Trial.","PURPOSE


To evaluate the effects of transcutaneous electrical nerve stimulation (TENS) compared to placebo TENS and a control group on pain, pulmonary function, respiratory muscle strength, and analgesic medications in the postoperative period of thoracotomy in an Intensive care unit (ICU).
METHODS


Patients who had undergone posterolateral thoracotomy were randomly allocated to receive TENS during ICU stay, or placebo TENS, or into the control group. All groups received conventional physiotherapy. We analysed the intensity of pain, pulmonary function, respiratory muscle strength, and use of analgesia medications. Outcomes were evaluated before surgery, immediately after, 24 and 48 h after ICU admission.
RESULTS


Forty-five patients were included. Regarding pain perception, there was no difference between groups (p = 0.172), but there was a significant reduction in pain intensity for patients receiving TENS after first physiotherapy session compared to baseline (4.7 ± 3.2 vs 3.3 ± 2.6; p < 0.05). All groups had a decrease in forced vital capacity (FVC) after surgery (p < 0.001). There was no difference between the groups regarding the use of analgesic medications, but a higher intake of morphine and acetaminophen were observed for the control (p = 0.037) and placebo group (p = 0.035), respectively.
CONCLUSION


The use of TENS provides a little benefit of pain (in the first 12 h) but failed to demonstrate any improvement in the recovery of ICU patients after 48 h of posterolateral thoracotomy.
TRIAL REGISTRATION


NCT02438241.",2020,All groups had a decrease in forced vital capacity (FVC) after surgery (p < 0.001).,"['Patients who had undergone posterolateral thoracotomy', 'Forty-five patients were included']","['Transcutaneous Electrical Nerve Stimulation', 'TENS', 'placebo TENS', 'placebo', 'TENS during ICU stay, or placebo TENS, or into the control group', 'conventional physiotherapy', 'transcutaneous electrical nerve stimulation (TENS']","['pain intensity', 'intensity of pain, pulmonary function, respiratory muscle strength, and use of analgesia medications', 'forced vital capacity (FVC', 'pain, pulmonary function, respiratory muscle strength, and analgesic medications', 'pain perception', 'higher intake of morphine and acetaminophen', 'pain', 'Pain, Pulmonary Function, and Respiratory Muscle Strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442951', 'cui_str': 'Posterolateral thoracotomy (procedure)'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",45.0,0.111358,All groups had a decrease in forced vital capacity (FVC) after surgery (p < 0.001).,"[{'ForeName': 'Hermann H', 'Initials': 'HH', 'LastName': 'Husch', 'Affiliation': 'Programa de Pós-Graduação Em Ciências Pneumológicas, Universidade Federal Do Rio Grande Do Sul, Rua Ramiro Barcelos, 2400, Porto Alegre, RS, 90035002, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Watte', 'Affiliation': 'Department of Clinical Research and Radiology, Liverpool Heart and Chest Hospital NHS Foundation Trust, Thomas Dr, Liverpool, L14 3PE, UK.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Zanon', 'Affiliation': 'Medical Imaging Research Laboratory, Federal University of Health Sciences of Porto Alegre, R. SarmentoLeite, 245, Porto Alegre, RS, 90050-170, Brazil.'}, {'ForeName': 'Gabriel Sartori', 'Initials': 'GS', 'LastName': 'Pacini', 'Affiliation': 'Medical Imaging Research Laboratory, Federal University of Health Sciences of Porto Alegre, R. SarmentoLeite, 245, Porto Alegre, RS, 90050-170, Brazil.'}, {'ForeName': 'Daniella', 'Initials': 'D', 'LastName': 'Birriel', 'Affiliation': 'Hospital Santa Casa de Misericórdia de Porto Alegre, Av. Independência, 75, Porto Alegre, 90020-160, Brazil.'}, {'ForeName': 'Pauline L', 'Initials': 'PL', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Rua Sarmento Leite, 245, Porto Alegre, 90050-170, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Kessler', 'Affiliation': 'Universidade Federal de Ciências da Saúde de Porto Alegre, Rua Sarmento Leite, 245, Porto Alegre, 90050-170, Brazil.'}, {'ForeName': 'Graciele', 'Initials': 'G', 'LastName': 'Sbruzzi', 'Affiliation': 'Programa de Pós-Graduação Em Ciências Pneumológicas, Universidade Federal Do Rio Grande Do Sul, Rua Ramiro Barcelos, 2400, Porto Alegre, RS, 90035002, Brazil. graciele.sbruzzi@ufrgs.br.'}]",Lung,['10.1007/s00408-020-00335-4']
393,31601479,Effect of Exercise on Taxane Chemotherapy-Induced Peripheral Neuropathy in Women With Breast Cancer: A Randomized Controlled Trial.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting adverse effect of taxanes. We sought to evaluate the effect of exercise on taxane CIPN in women with breast cancer.
PATIENTS AND METHODS


Women (n = 27) were randomized to immediate exercise (IE, during taxane chemotherapy) or delayed exercise (DE, after chemotherapy). Supervised aerobic, resistance, and balance training was offered 3 days a week for 8-12 weeks. CIPN symptoms and quality of life were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and CIPN20 (scored from 0 to 100). The percentage of participants reporting moderate to severe sensory symptoms ('3/4' or '4/4' for CIPN20 sensory items) was also evaluated, along with clinical sensory testing at the lower limb (vibration sense and pinprick). Taxane treatment adherence, including relative dose intensity, was extracted from patient medical records. Assessments occurred at: baseline (before taxane chemotherapy), pre-cycle 4 (before the final taxane cycle), the end of chemotherapy, and follow-up (10-15 weeks after chemotherapy).
RESULTS


No differences in the EORTC QLQ CIPN20 symptom scores were detected between groups at any time point. At pre-cycle 4, there was a significant difference between groups in patient-reported moderate to severe numbness in the toes or feet (IE: n = 1, 9%, DE: n = 7, 50%, P = .04) and impaired vibration sense in the feet (IE: n = 2, 18%, DE: n = 10, 83%, P < .01). Overall global health status/quality of life was higher in IE compared to DE at the end of chemotherapy (P = .05), yet both groups had worse CIPN20 sensory (Δ24.3 ± 4.6, P < .01) and motor symptom scores (Δ10.5 ± 1.9, P < .01) relative to baseline. By the end of chemotherapy, no differences between groups were found for moderate to severe numbness in the toes or feet (P = 1.0) or impaired vibration sense in the feet (P = .71). More IE participants received ≥ 85% relative dose intensity (IE: n = 12, 100%, DE: n = 10, 67%, P < .05).
CONCLUSION


Exercise may attenuate CIPN over the course of taxane chemotherapy and possibly improve taxane adherence in women with breast cancer. These findings, as well as whether exercise can attenuate CIPN by the end of taxane chemotherapy, should be confirmed in larger trials.",2019,"By the end of chemotherapy, no differences between groups were found for moderate to severe numbness in the toes or feet (P = 1.0) or impaired vibration sense in the feet (P = .71).","['women with breast cancer', 'Women With Breast Cancer', 'Women (n\xa0= 27']","['Taxane', 'Taxane Chemotherapy-Induced Peripheral Neuropathy', 'taxane chemotherapy', 'immediate exercise (IE, during taxane chemotherapy) or delayed exercise (DE, after chemotherapy', 'exercise', 'C30 and CIPN20', 'taxane CIPN', 'Exercise']","['motor symptom scores', 'CIPN symptoms and quality of life', 'severe sensory symptoms', 'Cancer Quality of Life Questionnaire (EORTC QLQ', 'Overall global health status/quality of life', 'EORTC QLQ CIPN20 symptom scores', 'severe numbness', 'taxane adherence', 'worse CIPN20 sensory', 'impaired vibration sense', 'vibration sense']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0423551', 'cui_str': 'Sensory symptoms (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0234198', 'cui_str': 'Vibratory sense, function'}]",,0.108314,"By the end of chemotherapy, no differences between groups were found for moderate to severe numbness in the toes or feet (P = 1.0) or impaired vibration sense in the feet (P = .71).","[{'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': 'Rehabilitation Sciences, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'Department of Biomedical Engineering, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Bovard', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Shenkier', 'Affiliation': 'British Columbia Cancer, Vancouver, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zucker', 'Affiliation': 'Swedish Cancer Institute, Swedish Medical Center, Seattle, WA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Margot K', 'Initials': 'MK', 'LastName': 'Davis', 'Affiliation': 'Division of Cardiology, Gordon & Leslie Diamond Health Care Centre, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer, Vancouver, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Rehabilitation Sciences, University of British Columbia, Vancouver, Canada; Department of Physical Therapy, University of British Columbia, Vancouver, Canada. Electronic address: kristin.campbell@ubc.ca.'}]",Clinical breast cancer,['10.1016/j.clbc.2019.05.013']
394,32228238,Reach Out Emergency Department: Partnering With an Economically Disadvantaged Community in the Development of a Text-Messaging Intervention to Address High Blood Pressure.,"Background.  Hypertension affects nearly 30% of the U.S. adult population. Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved. We present the intervention development of Reach Out, a health behavior theory-based, mobile health intervention to reduce blood pressure among hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans.  Aims.  To describe the process of designing and refining text messages currently being implemented in the Reach Out randomized controlled trial.  Method.  We used a five-step framework to develop the text messages used in Reach Out. These steps included literature review and community formative research, conception of a community-centered behavioral theoretical framework, draft of evidence-based text messages, community review, and revision based on community feedback and finalization.  Results . The Reach Out development process drew from pertinent evidence that, combined with community feedback, guided the development of a community-centered health behavior theory framework that led to development of text messages. A total of 333 generic and segmented messages were created. Messages address dietary choices, physical activity, hypertension medication adherence, and blood pressure monitoring.  Discussion.  Our five-step framework is intended to inform future text-messaging-based health promotion efforts to address health issues in vulnerable populations.  Conclusion . Text message-based health promotion programs should be developed in partnership with the local community to ensure acceptability and relevance.",2020,"Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved.","['Reach Out Emergency Department', 'hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans']",[],"['physical activity, hypertension medication adherence, and blood pressure monitoring', 'blood pressure', 'Hypertension']","[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",333.0,0.0398859,"Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Champoux', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Price', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Cowdery', 'Affiliation': 'Eastern Michigan University, Ypsilanti, MI, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Dinh', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Narmeen', 'Initials': 'N', 'LastName': 'Rehman', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Schille', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Oliver', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Devin L', 'Initials': 'DL', 'LastName': 'Brown', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Killingsworth', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Lesli E', 'Initials': 'LE', 'LastName': 'Skolarus', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}]",Health promotion practice,['10.1177/1524839920913550']
395,31683172,Use of a non-ICU specialty ward for immediate post-operative management of head and neck free flaps; a randomized controlled trial.,"OBJECTIVES


Compare length of stay, flap failure rate, medical and surgical complications and cost when patients undergoing head and neck free flap reconstruction are monitored in an intensive care unit (ICU) versus a specialty ward unit postoperatively.
MATERIALS AND METHODS


A prospective, non-inferiority, randomized controlled trial was conducted from 7/22/2016 to 9/12/2018 at a single institution. Patients were randomized to the ICU or specialty ward unit. Flap check protocols were identical between the groups. Perioperative and postoperative outcome variables were assessed and compared.
RESULTS


131 patients were enrolled in the study and 118 ultimately underwent head and neck free flap reconstruction. 57 were randomized to the ICU and 61 to the specialty ward unit. There were no significant differences between the ICU and specialty ward unit groups with regard to demographic variables including age, gender, co-morbidities, tobacco or alcohol use, prior chemotherapy or radiation therapy treatment. There were no significant differences in perioperative variables including need for transfusion, tracheostomy, ischemia time, blood loss, fluid administration or post-operative antibiotic use. There was no significant difference in the primary outcome variable, length of stay. There were no significant differences in the number of the medical or surgical complications, flap failure rate, or hospital costs.
CONCLUSION


In this prospective, randomized controlled trial, head and neck free-flap patients cared for on a specialty ward in the immediate post-operative period had equivalent outcomes to those cared for in the ICU.",2019,"There were no significant differences in perioperative variables including need for transfusion, tracheostomy, ischemia time, blood loss, fluid administration or post-operative antibiotic use.","['patients undergoing head and neck free flap reconstruction are monitored in an intensive care unit (ICU) versus a specialty ward unit postoperatively', 'head and neck free flaps', '131 patients were enrolled in the study and 118 ultimately underwent head and neck free flap reconstruction', 'head and neck free-flap patients cared for on a specialty ward in the immediate post-operative period had equivalent outcomes to those cared for in the ICU']",['ICU'],"['number of the medical or surgical complications, flap failure rate, or hospital costs', 'perioperative variables including need for transfusion, tracheostomy, ischemia time, blood loss, fluid administration or post-operative antibiotic use', 'length of stay, flap failure rate, medical and surgical complications and cost', 'length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0441031', 'cui_str': 'Microsurgical Free Flaps'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0017313'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0438398', 'cui_str': 'Flap failure (disorder)'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",131.0,0.0503882,"There were no significant differences in perioperative variables including need for transfusion, tracheostomy, ischemia time, blood loss, fluid administration or post-operative antibiotic use.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cervenka', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Olinde', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gould', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Farwell', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaufman', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Bewley', 'Affiliation': 'Department of Otolaryngology, Division of Head and Neck Surgery, University of California, Davis, 2521 Stockton Blvd., Sacramento, CA 95817, United States. Electronic address: abewley@ucdavis.edu.'}]",Oral oncology,['10.1016/j.oraloncology.2019.104464']
396,30393950,"Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study.","AIMS


To compare the effects of continuing versus discontinuing sitagliptin when initiating and intensively titrating insulin glargine.
MATERIALS AND METHODS


Eligible patients had inadequately controlled type 2 diabetes on metformin (≥1500 mg/d) in combination with a dipeptidyl peptidase-4 (DPP-4) inhibitor and/or a sulphonylurea. Those on metformin + sitagliptin were directly randomized; all others were switched to metformin + sitagliptin (discontinuing other DPP-4 inhibitors and sulphonylureas) and stabilized during a run-in period. At randomization, patients were allocated to continuing sitagliptin or discontinuing sitagliptin, with both groups initiating insulin glargine and titrating to a target fasting glucose of 4.0 to 5.6 mmol/L.
RESULTS


A total of 743 participants (mean glycated haemoglobin [HbA1c] 72.6 mmol/mol [8.8%], disease duration 10.8 years), were treated. After 30 weeks, the mean HbA1c and least squares (LS) mean change from baseline in HbA1c were 51.4 mmol/mol (6.85%) and -20.5 mmol/mol (-1.88%) in the sitagliptin group and 56.4 mmol/mol (7.31%) and -15.5 mmol/mol (-1.42%) in the placebo group; the difference in LS mean changes from baseline HbA1c was -5.0 mmol/mol (-0.46%; P < 0.001). The percentage of participants with HbA1c <53 mmol/mol (<7.0%) was higher (54% vs. 35%) and the mean daily insulin dose was lower (53 vs. 61 units) in the sitagliptin group. Despite lower HbA1c, event rates and incidences of hypoglycaemia were not higher in the sitagliptin group. Adverse events overall and changes from baseline in body weight were similar between the two treatment groups.
CONCLUSION


When initiating insulin glargine therapy, continuation of sitagliptin, compared with discontinuation, resulted in a clinically meaningful greater reduction in HbA1c without an increase in hypoglycaemia. ClinicalTrials.gov Identifier: NCT02738879.",2019,"Despite lower HbA1c, event rates and incidences of hypoglycaemia were not higher in the sitagliptin group.","['Eligible patients had inadequately controlled type 2 diabetes on metformin (≥1500\u2009mg/d) in combination with a', 'patients with type 2 diabetes', '743 participants (mean glycated haemoglobin [HbA1c] 72.6 mmol/mol [8.8%], disease duration 10.8 years']","['metformin\u2009+\u2009sitagliptin', 'dipeptidyl peptidase-4', 'placebo', 'continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin', 'continuing sitagliptin or discontinuing sitagliptin, with both groups initiating insulin glargine and titrating to a target fasting glucose of 4.0 to 5.6 mmol/L.\nRESULTS', 'sulphonylurea', 'metformin\u2009+\u2009sitagliptin (discontinuing other DPP-4 inhibitors and sulphonylureas']","['mean HbA1c and least squares (LS) mean change from baseline in HbA1c', 'HbA1c, event rates and incidences of hypoglycaemia', 'hypoglycaemia', 'efficacy and safety', 'mean daily insulin dose', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl-Peptidase IV'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",743.0,0.112032,"Despite lower HbA1c, event rates and incidences of hypoglycaemia were not higher in the sitagliptin group.","[{'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Roussel', 'Affiliation': 'Diabetology Endocrinology Nutrition, Hôpital Bichat, DHU FIRE, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Duran-García', 'Affiliation': 'Endodiabesidad Clinica Durán and Asociados, Universidad de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Suneri', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Darmiento', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'R Ravi', 'Initials': 'RR', 'LastName': 'Shankar', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Golm', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Raymond L H', 'Initials': 'RLH', 'LastName': 'Lam', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': ""O'Neill"", 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Kaufman', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13574']
397,30393955,Achieving LDL cholesterol target levels <1.81 mmol/L may provide extra cardiovascular protection in patients at high risk: Exploratory analysis of the Standard Versus Intensive Statin Therapy for Patients with Hypercholesterolaemia and Diabetic Retinopathy study.,"AIMS


To assess the benefits of intensive statin therapy on reducing cardiovascular (CV) events in patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan. In the intension-to-treat population, intensive therapy [targeting LDL cholesterol <1.81 mmol/L (<70 mg/dL)] was no more effective than standard therapy [LDL cholesterol ≥2.59 to <3.10 mmol/L (≥100 to <120 mg/dL)]; however, after 3 years, the intergroup difference in LDL cholesterol was only 0.72 mmol/L (27.7 mg/dL), and targeted levels were achieved in <50% of patients. We hypothesized that the intergroup difference in CV events would have been statistically significant if more patients had been successfully treated to target.
MATERIALS AND METHODS


This exploratory post hoc analysis focused on intergroup data from patients who achieved their target LDL cholesterol levels. The primary endpoint was the composite incidence of CV events. A Cox proportional hazards model was used to estimate hazard ratios (HRs) for incidence of the primary endpoint in patients who achieved target LDL cholesterol levels in each group.
RESULTS


Data were analysed from 1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels. LDL cholesterol at 36 months was 1.54 ± 0.30 mmol/L (59.7 ± 11.6 mg/dL) in the intensive group and 2.77 ± 0.46 mmol/L (107.1 ± 17.8 mg/dL) in the standard group (P < 0.05). After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007).
CONCLUSIONS


This post hoc analysis suggests that achieving LDL cholesterol target levels <1.81 mmol/L may more effectively reduce CV events than achieving target levels ≥2.59 to <3.10 mmol/L in patients with hypercholesterolaemia and diabetic retinopathy.",2019,"After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007).
","['Patients with Hypercholesterolaemia and Diabetic Retinopathy study', 'patients with type 2 diabetes complicated with hyperlipidaemia and retinopathy in a primary prevention setting in Japan', 'patients who achieved their target LDL cholesterol levels', 'patients with hypercholesterolaemia and diabetic retinopathy', '1909 patients (intensive: 703; standard: 1206) who achieved target LDL cholesterol levels']",['intensive statin therapy'],"['cardiovascular (CV) events', 'composite incidence of CV events or deaths associated with CV events', 'CV events', 'LDL cholesterol', 'Achieving LDL cholesterol target levels', 'LDL cholesterol levels', 'composite incidence of CV events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",1909.0,0.160862,"After adjusting for baseline prognostic factors, the composite incidence of CV events or deaths associated with CV events was significantly lower in the intensive than the standard group (HR 0.48; 95% confidence interval 0.28-0.82; P = 0.007).
","[{'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Department of Endocrinology, Metabolism and Nephrology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': 'Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akasaka', 'Affiliation': 'Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Egashira', 'Affiliation': 'Sakura Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiology, Saitama Medical Centre, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Jitsuo', 'Initials': 'J', 'LastName': 'Higaki', 'Affiliation': 'Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine, Toon, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Hirata', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Ishibashi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Isshiki', 'Affiliation': 'Division of Cardiology, Cardiovascular Centre, Ageo Central General Hospital, Ageo, Japan.'}, {'ForeName': 'Sadayoshi', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kashiwagi', 'Affiliation': 'Kusatsu General Hospital, Kusatsu, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Ophthalmology, University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Division of Cardiology, National Cerebral and Cardiovascular Centre, Suita, Japan.'}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Kurabayashi', 'Affiliation': 'Department of Medicine and Biological Science, Gunma University Graduate School of Medicine, Maebashi, Japan.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiology, Graduate School of Medicine Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Department of Ophthalmology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Murohara', 'Affiliation': 'Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Ogawa', 'Affiliation': 'Division of Nephrology, Endocrinology and Vascular Medicine, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'First Department of Internal Medicine, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Department of Cardiology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shigeeda', 'Affiliation': 'Ideta Eye Clinic, Kumamoto, Japan.'}, {'ForeName': 'Shunya', 'Initials': 'S', 'LastName': 'Shindo', 'Affiliation': 'Department of Cardiovascular Surgery, Tokyo Medical University Hachioji Medical Centre, Hachioji, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sugawara', 'Affiliation': 'Sugawara Medical Clinic, Tokyo, Japan.'}, {'ForeName': 'Seigo', 'Initials': 'S', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Cardiology, Jinnouchi Hospital, Kumamoto, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Cardiovascular Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Utsunomiya', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamagishi', 'Affiliation': 'Department of Cardiovascular and Internal Medicine, Kanazawa University Graduate School of Medicine, Kanazawa, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Clinical Research Support Centre, University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Shoei', 'Initials': 'S', 'LastName': 'Yo', 'Affiliation': 'Yo Clinic, Kyoto, Japan.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Clinical Cell Biology and Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Sakakibara Heart Institute of Okayama, Okayama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nagahisa', 'Initials': 'N', 'LastName': 'Yoshimura', 'Affiliation': 'Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Kazuwa', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Medical Innovation Centre, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ryozo', 'Initials': 'R', 'LastName': 'Nagai', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13575']
398,30565407,BioChaperone Lispro versus faster aspart and insulin aspart in patients with type 1 diabetes using continuous subcutaneous insulin infusion: A randomized euglycemic clamp study.,"We investigated the pharmacodynamics (PD) and pharmacokinetics (PK) of BioChaperone insulin Lispro (BCLIS), faster insulin aspart (FIA) and insulin aspart (ASP) in patients with type 1 diabetes using an insulin pump. In this randomized, double-blind, three-way crossover glucose clamp study, 43 patients received a bolus dose of each insulin (0.15 U/kg) in addition to a basal rate (0.01 U/kg/h), delivered via an insulin pump. With BCLIS, the AUC-GIR,0-60 minutes (primary endpoint) was improved compared to ASP (least square means ratio, 1.63; 95% CI, 1.44-1.88; P < 0.0001) and was similar compared to FIA (least square means ratio, 1.06; 95% CI, 0.94-1.18; P = 0.4609). BCLIS showed faster-on PD (t early0.5GIRmax  ) than ASP and faster-off PD (t late0.5GIRmax  ) than both FIA and ASP. BCLIS also demonstrated significantly higher early exposure (AUCins, 0-60 minutes) and lower late exposure (AUCins,120-600 minutes) than both other insulins. In patients with type 1 diabetes using an insulin pump, BCLIS better mimics prandial insulin secretion and action than ASP and shows a faster off-PD than FIA.",2019,"With BCLIS, the AUC-GIR,0-60 minutes (primary endpoint) was improved compared to ASP (least square means ratio, 1.63; 95% CI, 1.44-1.88; P < 0.0001) and was similar compared to FIA (least square means ratio, 1.06; 95% CI, 0.94-1.18; P = 0.4609).","['patients with type 1 diabetes', 'patients with type 1 diabetes using an insulin pump', 'patients with type 1 diabetes using continuous subcutaneous insulin infusion', '43 patients']","['BioChaperone Lispro versus faster aspart and insulin aspart', 'BioChaperone insulin Lispro (BCLIS), faster insulin aspart (FIA) and insulin aspart (ASP', 'insulin pump, BCLIS']",['pharmacodynamics (PD) and pharmacokinetics (PK'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.224366,"With BCLIS, the AUC-GIR,0-60 minutes (primary endpoint) was improved compared to ASP (least square means ratio, 1.63; 95% CI, 1.44-1.88; P < 0.0001) and was similar compared to FIA (least square means ratio, 1.06; 95% CI, 0.94-1.18; P = 0.4609).","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Meiffren', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Alluis', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Seroussi', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Ranson', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arrubla', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Correia', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gaudier', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Soula', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Soula', 'Affiliation': 'Adocia, Lyon, France.'}, {'ForeName': 'J Hans', 'Initials': 'JH', 'LastName': 'DeVries', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Klein', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13621']
399,32227179,Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial.,"Importance


There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care.
Objective


To examine whether default options in ADs influence care choices and clinical outcomes.
Design, Setting, and Participants


This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019.
Interventions


Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD).
Main Outcomes and Measures


This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care.
Results


Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes.
Conclusions and Relevance


In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02017548.",2020,"There were no differences among groups in other secondary outcomes.
","['Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months', 'November 2018 to April 2019', '515 patients who met criteria for having serious illness and agreed to participate', '515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer', 'Seriously Ill Patients', '492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the']","['comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD']","['comfort care', 'life-extending AD chose comfort care', ""choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care"", 'Hospital-Free Days and Care Choices', 'legally valid ADs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0150521', 'cui_str': 'Comfort Care'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0421611', 'cui_str': 'Place of death (observable entity)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",515.0,0.193088,"There were no differences among groups in other secondary outcomes.
","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Halpern', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cooney', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bayes', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Marzana', 'Initials': 'M', 'LastName': 'Chowdhury', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tomko', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Loewenstein', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Palliative and Advanced Illness Research (PAIR) Center, Perelman School of Medicine, the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1742']
400,32219359,Effect of Apabetalone Added to Standard Therapy on Major Adverse Cardiovascular Events in Patients With Recent Acute Coronary Syndrome and Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Bromodomain and extraterminal proteins are epigenetic regulators of gene transcription. Apabetalone is a selective bromodomain and extraterminal protein inhibitor targeting bromodomain 2 and is hypothesized to have potentially favorable effects on pathways related to atherothrombosis. Pooled phase 2 data suggest favorable effects on clinical outcomes.
Objective


To test whether apabetalone significantly reduces major adverse cardiovascular events.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled trial, conducted at 190 sites in 13 countries. Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019.
Interventions


Patients were randomized (1:1) to receive apabetalone, 100 mg orally twice daily (n = 1215), or matching placebo (n = 1210) in addition to standard care.
Main Outcomes and Measures


The primary outcome was a composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke.
Results


Among 2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome. During a median follow-up of 26.5 months, 274 primary end points occurred: 125 (10.3%) in apabetalone-treated patients and 149 (12.4%) in placebo-treated patients (hazard ratio, 0.82 [95% CI, 0.65-1.04]; P = .11). More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
Conclusions and Relevance


Among patients with recent acute coronary syndrome, type 2 diabetes, and low high-density lipoprotein cholesterol levels, the selective bromodomain and extraterminal protein inhibitor apabetalone added to standard therapy did not significantly reduce the risk of major adverse cardiovascular events.
Trial Registration


ClinicalTrials.gov Identifier: NCT02586155.",2020,"More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
","['2425 patients who were randomized (mean age, 62 years; 618 women [25.6%]), 2320 (95.7%) had full ascertainment of the primary outcome', 'controlled trial, conducted at 190 sites in 13 countries', 'Patients', 'patients with recent acute coronary syndrome, type 2 diabetes', 'Patients with an acute coronary syndrome in the preceding 7 to 90 days, type 2 diabetes, and low high-density lipoprotein cholesterol levels were eligible for enrollment, which started November 11, 2015, and ended July 4, 2018, with end of follow-up on July 3, 2019']","['apabetalone, 100 mg orally twice daily (n\u2009=\u20091215), or matching placebo', 'Apabetalone Added to Standard Therapy', 'placebo']","['composite of time to the first occurrence of cardiovascular death, nonfatal myocardial infarction, or stroke', 'elevations of liver enzyme levels', 'Major Adverse Cardiovascular Events', 'major adverse cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1287351', 'cui_str': 'Finding of liver enzyme levels (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",2425.0,0.633565,"More patients allocated to apabetalone than placebo discontinued study drug (114 [9.4%] vs 69 [5.7%]) for reasons including elevations of liver enzyme levels (35 [2.9%] vs 11 [0.9%]).
","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, United Kingdom.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Buhr', 'Affiliation': 'Statistical Data Analysis Center, University of Wisconsin-Madison.'}, {'ForeName': 'Henry N', 'Initials': 'HN', 'LastName': 'Ginsberg', 'Affiliation': 'Irving Institute for Clinical and Translational Research, Columbia University, New York, New York.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Johansson', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Kalantar-Zadeh', 'Affiliation': 'Division of Nephrology and Hypertension, University of California-Irvine.'}, {'ForeName': 'Ewelina', 'Initials': 'E', 'LastName': 'Kulikowski', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Toth', 'Affiliation': 'CGH Medical Center, Sterling, Illinois, and Cicarrone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sweeney', 'Affiliation': 'Resverlogix Corporation, Calgary, Alberta, Canada.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.3308']
401,31916633,"Effectiveness of video-assisted, self-directed, and peer-guided learning in the acquisition of surgical skills by veterinary students.","OBJECTIVE


To determine the influence of self-directed learning, peer feedback, or expert feedback on suturing technique of novice veterinary student surgeons.
STUDY DESIGN


Prospective, blinded, video feedback study.
SAMPLE POPULATION


Three groups of surgery naïve veterinary students, two groups of 37 students and one group with 36 students.
METHODS


Each student completed three cruciate sutures in SynDaver skin. Student performance was video recorded and scored with a validated pro forma. Students were randomly divided into three groups: (1) students critically evaluated their own performance, (2) students critically evaluated peer's performance, and (3) students received a peer's evaluation. Each student repeated the surgical task and assessed his or her own performance, guided by the pro forma. Each student received a video with individualized feedback from an expert prior to repeating the task. Scores and times were analyzed. Student and expert evaluations were compared.
RESULTS


Task composite score, time to completion, and completion rate did not differ between groups. Student self-assessed scores did not correlate with expert scores. Forty-three percent and 62% of students stated that self-feedback and peer feedback, respectively, were acceptable forms of learning, and 96% of students felt expert feedback was superior to both.
CONCLUSION


Video-based self-evaluation and peer-assisted learning were as effective as expert feedback after didactic lecture in teaching suturing technique to novice veterinary surgeons.
CLINICAL SIGNIFICANCE


Video-based self-evaluation and peer feedback were viable alternative teaching strategies to didactic lecture and expert feedback alone for instructing novice veterinary surgeons.",2020,"CLINICAL SIGNIFICANCE


Video-based self-evaluation and peer feedback were viable alternative teaching strategies to didactic lecture and expert feedback alone for instructing novice veterinary surgeons.","['Three groups of surgery naïve veterinary students, two groups of 37 students and one group with 36 students', ""Students were randomly divided into three groups: (1) students critically evaluated their own performance, (2) students critically evaluated peer's performance, and (3) students received a peer's evaluation"", 'veterinary students']","['video-assisted, self-directed, and peer-guided learning', 'cruciate sutures in SynDaver skin', 'Video-based self-evaluation and peer-assisted learning', 'self-directed learning, peer feedback, or expert feedback']","['self-feedback and peer feedback', 'Task composite score, time to completion, and completion rate']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2936633', 'cui_str': 'Self-Evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0153723,"CLINICAL SIGNIFICANCE


Video-based self-evaluation and peer feedback were viable alternative teaching strategies to didactic lecture and expert feedback alone for instructing novice veterinary surgeons.","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coffman', 'Affiliation': 'Department of Small Animal Clinical Sciences, College of Veterinary Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Marina J', 'Initials': 'MJ', 'LastName': 'McConkey', 'Affiliation': 'Department of Small Animal Clinical Sciences, College of Veterinary Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Colee', 'Affiliation': 'IFAS Statistical Consulting Unit, University of Florida, Gainesville, Florida.'}]",Veterinary surgery : VS,['10.1111/vsu.13368']
402,32098484,"Examination of using alcohol to cope, depressive symptoms, and perceived social support in persons with HIV and Hepatitis C.","Depression is common among people living with HIV (PLWH) and some likely turn to alcohol to cope with this emotional distress. Using alcohol to cope is associated with increased alcohol use, persistent longitudinal alcohol use, and alcohol-related problems. This association is particularly concerning among PLWH who are co-infected with Hepatitis C (HCV) because alcohol adds to the damage already caused by HCV. Despite data showing the associated risks of using alcohol to cope, scant research has examined factors that might contribute to coping-based alcohol use in HIV-HCV patients, such as limited social support. Baseline data from a randomized trial of strategies to reduce alcohol use in co-infected HIV and HCV adult patients (n=110) were analyzed. Multiple linear regression models were used to estimate the association between using alcohol to cope, depression, and four aspects of social support, controlling for demographic variables. Results showed that using alcohol to cope was not significantly correlated with social support but was significantly correlated with depressive symptoms. In fact, depressive symptoms and severity of alcohol consumption accounted for nearly 45% of the variance related to coping-based alcohol use. These data highlight the central role of depression in the coping motives-alcohol use relationship among co-infected patients.",2020,Results showed that using alcohol to cope was not significantly correlated with social support but was significantly correlated with depressive symptoms.,"['co-infected HIV and HCV adult patients (n=110', 'people living with HIV (PLWH', 'persons with HIV and Hepatitis C']",[],"['depressive symptoms', 'depressive symptoms and severity of alcohol consumption']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",110.0,0.014857,Results showed that using alcohol to cope was not significantly correlated with social support but was significantly correlated with depressive symptoms.,"[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': 'Behavioral Medicine and Addictions Research Unit, Butler Hospital, Providence RI, USA.'}, {'ForeName': 'Debra S', 'Initials': 'DS', 'LastName': 'Herman', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'Department of Psychology, College of the Holy Cross, Worcester MA, USA.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Pinkston', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence RI, USA.'}, {'ForeName': 'H Nina', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Global Health, University of Washington, Seattle WA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Stein', 'Affiliation': 'Department of Health Law, Policy and Management, Boston University School of Public Health, Boston MA, USA.'}]",AIDS care,['10.1080/09540121.2020.1734177']
403,30939507,"Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial.","OBJECTIVE


To assess the safety and efficacy of tranexamic acid (TXA) use in fractures of the pelvic ring, acetabulum, and proximal femur.
DESIGN


Prospective, randomized controlled trial.
SETTING


Single Level 1 trauma center.
PATIENTS


Forty-seven patients were randomized to the study group, and 46 patients comprised the control group.
INTERVENTION


The study group received 15 mg/kg IV TXA before incision and a second identical dose 3 hours after the initial dose.
MAIN OUTCOME MEASUREMENTS


Transfusion rates and total blood loss (TBL) [via hemoglobin-dilution method and rates of venous thromboembolic events (VTEs)].
RESULTS


TBL was significantly higher in the control group (TXA = 952 mL, no TXA = 1325 mL, P = 0.028). The total transfusion rates between the TXA and control groups were not significantly different (TXA 1.51, no TXA = 1.17, P = 0.41). There were no significant differences between the TXA and control groups in inpatient VTE events (P = 0.57).
CONCLUSION


The use of TXA in high-energy fractures of the pelvis, acetabulum, and femur significantly decreased calculated TBL but did not decrease overall transfusion rates. TXA did not increase the rate of VTE. Further study is warranted before making broad recommendations for the use of TXA in these fractures.
LEVEL OF EVIDENCE


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2019,There were no significant differences between the TXA and control groups in inpatient VTE events (p=0.57) CONCLUSION::,"[' Single Level 1 trauma center PATIENTS:: Fourty-seven patients were randomized to the study group and 46 patients', 'Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur']","['15mg/kg IV TXA', 'Tranexamic Acid', 'tranexamic acid(TXA', 'TXA']","['overall transfusion rates', 'total blood loss', 'transfusion rates, total blood loss (via hemoglobin dilutional method, rates of venous thromboembolic events', 'rate of VTE', 'total transfusion rates', 'Total blood loss']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1297885', 'cui_str': 'Open reduction with internal fixation'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0000962', 'cui_str': 'Cotyloid Cavity'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0745003,There were no significant differences between the TXA and control groups in inpatient VTE events (p=0.57) CONCLUSION::,"[{'ForeName': 'Clay A', 'Initials': 'CA', 'LastName': 'Spitler', 'Affiliation': 'Department of Orthopaedic Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Elliot R', 'Initials': 'ER', 'LastName': 'Row', 'Affiliation': 'Department of Orthopaedic Surgery, Baylor University Medical Center, Dallas, TX.'}, {'ForeName': 'Warren E', 'Initials': 'WE', 'LastName': 'Gardner', 'Affiliation': 'Department of Orthopaedic Surgery, University of Tennessee College of Medicine Chattanooga, Chattanooga, TN.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Swafford', 'Affiliation': 'Department of Orthopaedic Surgery, University of Tennessee College of Medicine Chattanooga, Chattanooga, TN.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hankins', 'Affiliation': 'Department of Orthopaedic Surgery, University of Tennessee Health Sciences Center, Chattanooga, TN.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Nowotarski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Tennessee College of Medicine Chattanooga, Chattanooga, TN.'}, {'ForeName': 'Dirk W', 'Initials': 'DW', 'LastName': 'Kiner', 'Affiliation': 'Department of Orthopaedic Surgery, University of Tennessee College of Medicine Chattanooga, Chattanooga, TN.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001480']
404,32207048,"Effect of the ""Recruitment"" Maneuver on Respiratory Mechanics in Laparoscopic Sleeve Gastrectomy Surgery.","PURPOSE


LSG surgery is used for surgical treatment of morbid obesity. Obesity, anesthesia, and pneumoperitoneum cause reduced pulmoner functions and a tendency for atelectasis. The alveolar ""recruitment"" maneuver (RM) keeps airway pressure high, opening alveoli, and increasing arterial oxygenation. The aim of our study is to research the effect on respiratory mechanics and arterial blood gases of performing the RM in LSG surgery.
MATERIALS AND METHODS


Sixty patients undergoing LSG surgery were divided into two groups (n = 30) Patients in group R had the RM performed 5 min after desufflation with 100% oxygen, 40 cmH 2 O pressure for 40 s. Group C had standard mechanical ventilation. Assessments of respiratory mechanics and arterial blood gases were made in the 10th min after induction (T1), 10th min after insufflation (T2), 5th min after desufflation (T3), and 15th min after desufflation (T4). Arterial blood gases were assessed in the 30th min (T5) in the postoperative recovery unit.
RESULTS


In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum. At T4, the compliance in the recruitment group was higher. In both groups, there was an increase in PIP with pneumoperitoneum and after desufflation this was identified to reduce to levels before pneumoperitoneum.
CONCLUSION


Adding the RM to PEEP administration for morbidly obese patients undergoing LSG surgery is considered to be effective in improving respiratory mechanics and arterial blood gas values and can be used safely.",2020,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","['morbidly obese patients undergoing LSG surgery', 'Laparoscopic Sleeve Gastrectomy Surgery', 'Sixty patients undergoing LSG surgery']","['RM performed 5\xa0min after desufflation with 100% oxygen, 40\xa0cmH 2 O pressure for 40\xa0s. Group C had standard mechanical ventilation', 'Recruitment"" Maneuver']","['Arterial blood gases', 'respiratory mechanics and arterial blood gases', 'PIP with pneumoperitoneum', 'Respiratory Mechanics', 'respiratory mechanics and arterial blood gas values']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0255194,"In group R, values at T5, PaO 2  were significantly high, while PaCO 2  were significantly low compared with group C. Compliance in both groups reduced with pneumoperitoneum.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Sümer', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. isumer@bezmialem.edu.tr.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Topuz', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Selçuk', 'Initials': 'S', 'LastName': 'Alver', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, İstanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Umutoglu', 'Affiliation': 'İstanbul Acıbadem Taksim Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mefkur', 'Initials': 'M', 'LastName': 'Bakan', 'Affiliation': 'Health Cares Vocational School, İstanbul Esenyurt University, Istanbul, Turkey.'}, {'ForeName': 'Seniyye Ülgen', 'Initials': 'SÜ', 'LastName': 'Zengin', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Halil', 'Initials': 'H', 'LastName': 'Coşkun', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Cerrahpasa Faculty of Medicine, İstanbul University Cerrahpasa, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04551-y']
405,32203065,"Double-blinded, placebo-controlled crossover trial to determine the effects of midodrine on blood pressure during cognitive testing in persons with SCI.","STUDY DESIGN


Clinical trial.
OBJECTIVES


Individuals with spinal cord injury (SCI) above T6 experience impaired descending cortical control of the autonomic nervous system, which predisposes them to hypotension. However, treatment of hypotension is uncommon in the SCI population because there are few safe and effective pharmacological options available. The primary aim of this investigation was to test the efficacy of a single dose of midodrine (10 mg), compared with placebo, to increase and normalize systolic blood pressure (SBP) between 110 and 120 mmHg during cognitive testing in hypotensive individuals with SCI. Secondary aims were to determine the effects of midodrine on cerebral blood flow velocity (CBFv) and global cognitive function.
SETTING


United States clinical research laboratory.
METHODS


Forty-one healthy hypotensive individuals with chronic (≥1-year post injury) SCI participated in this 2-day study. Seated SBP, CBFv, and cognitive performance were monitored before and after administration of identical encapsulated tablets, containing either midodrine or placebo.
RESULTS


Compared with placebo, midodrine increased SBP (4 ± 13 vs. 18 ± 24 mmHg, respectively; p < 0.05); however, responses varied widely with midodrine (-15.7 to +68.6 mmHg). Further, the proportion of SBP recordings within the normotensive range did not improve during cognitive testing with midodrine compared with placebo. Although higher SBP was associated with higher CBFv (p = 0.02), global cognitive function was not improved with midodrine.
CONCLUSIONS


The findings indicate that midodrine increases SBP and may be beneficial in some hypotensive patients with SCI; however, large heterogeneity of responses to midodrine suggests careful monitoring of patients following administration.
CLINICAL TRIALS REGISTRATION


NCT02307565.",2020,"Although higher SBP was associated with higher CBFv (p = 0.02), global cognitive function was not improved with midodrine.
","['Forty-one healthy hypotensive individuals with chronic (≥1-year post injury) SCI participated in this 2-day study', 'hypotensive patients with SCI', 'persons with SCI', 'Individuals with spinal cord injury (SCI) above T6 experience impaired descending cortical control of the autonomic nervous system, which predisposes them to hypotension', 'hypotensive individuals with SCI']","['midodrine or placebo', 'placebo', 'placebo, midodrine', 'midodrine']","['SBP', 'normalize systolic blood pressure (SBP', 'blood pressure', 'cerebral blood flow velocity (CBFv) and global cognitive function', 'global cognitive function', 'Seated SBP, CBFv, and cognitive performance']","[{'cui': 'C0857353', 'cui_str': 'Hypotensive'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",41.0,0.222919,"Although higher SBP was associated with higher CBFv (p = 0.02), global cognitive function was not improved with midodrine.
","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Wecht', 'Affiliation': 'James J Peters VA Medical Center, Bronx, NY, USA. Jill.Wecht@va.gov.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Weir', 'Affiliation': 'University of Kansas, Lawrence, KS, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Katzelnick', 'Affiliation': 'James J Peters VA Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Dyson-Hudson', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Weber', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'James J Peters VA Medical Center, Bronx, NY, USA.'}]",Spinal cord,['10.1038/s41393-020-0448-0']
406,32406343,Response to invited commentary: Vitamin D 3  supplementation for 8 weeks leads to improved haematological status following the consumption of an iron-fortified breakfast cereal: a double-blind randomised controlled trial in iron-deficient women.,,2020,,['iron-deficient women'],[],['haematological status'],"[{'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0449438', 'cui_str': 'Status'}]",,0.572926,,"[{'ForeName': 'Salma F', 'Initials': 'SF', 'LastName': 'Ahmad Fuzi', 'Affiliation': 'Faculty of Medicine, Dentistry and Life Sciences, University of Chester, ChesterCH1 4BJ, UK.'}, {'ForeName': 'Sohail', 'Initials': 'S', 'LastName': 'Mushtaq', 'Affiliation': 'Faculty of Medicine, Dentistry and Life Sciences, University of Chester, ChesterCH1 4BJ, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001683']
407,31995570,Preconception nutrition intervention improved birth length and reduced stunting and wasting in newborns in South Asia: The Women First Randomized Controlled Trial.,"South Asia has >50% of the global burden of low birth weight (LBW). The objective was to determine the extent to which maternal nutrition interventions commenced before conception or in the 1st trimester improved fetal growth in this region. This was a secondary analysis of combined newborn anthropometric data for the South Asian sites (India and Pakistan) in the Women First Preconception Maternal Nutrition Trial. Participants were 972 newborn of mothers who were poor, rural, unselected on basis of nutritional status, and had been randomized to receive a daily lipid-based micronutrient supplement commencing ≥3 months prior to conception (Arm 1), in the 1st trimester (Arm 2), or not at all (Arm 3). An additional protein-energy supplement was provided if BMI <20 kg/m2 or gestational weight gain was less than guidelines. Gestational age was established in the 1st trimester and newborn anthropometry obtained <48-hours post-delivery. Mean differences at birth between Arm 1 vs. 3 were length +5.3mm and weight +89g. Effect sizes (ES) and relative risks (RR) with 95% CI for Arm 1 vs. 3 were: length-for-age Z-score (LAZ) +0.29 (0.11-0.46, p = 0.0011); weight-for-age Z-score (WAZ) +0.22 (0.07-0.37, p = 0.0043); weight-to-length-ratio-for-age Z-score (WLRAZ) +0.27 (0.06-0.48, p = 0.0133); LAZ<-2, 0.56 (0.38-0.82, p = 0.0032); WAZ <-2, 0.68 (0.53-0.88, p = 0.0028); WLRAZ <-2, 0.76 (0.64-0.89, p = 0.0011); small-for-gestational-age (SGA), 0.74 (0.66-0.83, p<0.0001); low birth weight 0.81 (0.66-1.00, p = 0.0461). For Arm 2 vs. 3, LAZ, 0.21 (0.04-0.38); WAZ <-2, 0.70 (0.53-0.92); and SGA, 0.88 (0.79-0.97) were only marginally different. ES or RR did not differ for preterm birth for either Arm 1 vs. 3 or 2 vs. 3. In conclusion, point estimates for both continuous and binary anthropometric outcomes were consistently more favorable when maternal nutrition supplements were commenced ≥3 months prior to conception indicating benefits to fetal growth of improving women's nutrition in this population.",2020,"For Arm 2 vs. 3, LAZ, 0.21 (0.04-0.38); WAZ <-2, 0.70 (0.53-0.92); and SGA, 0.88 (0.79-0.97) were only marginally different.","['Participants were 972 newborn of mothers who were poor, rural, unselected on basis of nutritional status', 'South Asian sites (India and Pakistan) in the Women First Preconception Maternal Nutrition Trial', 'newborns in South Asia']","['Preconception nutrition intervention', 'daily lipid-based micronutrient supplement commencing ≥3 months prior to conception']","['Effect sizes (ES) and relative risks (RR', 'birth length and reduced stunting and wasting']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0419415', 'cui_str': 'Birth length (observable entity)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",972.0,0.179765,"For Arm 2 vs. 3, LAZ, 0.21 (0.04-0.38); WAZ <-2, 0.70 (0.53-0.92); and SGA, 0.88 (0.79-0.97) were only marginally different.","[{'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.""}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'Pediatric Nutrition, University of Colorado School of Medicine, Aurora, Colorado, United States of America.'}, {'ForeName': 'Sumera Aziz', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Somannavar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Omrana', 'Initials': 'O', 'LastName': 'Pasha', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Umber', 'Initials': 'U', 'LastName': 'Khan', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Herekar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.""}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Vernekar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.""}, {'ForeName': 'Yogesh', 'Initials': 'Y', 'LastName': 'Kumar S', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.""}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Westcott', 'Affiliation': 'Pediatric Nutrition, University of Colorado School of Medicine, Aurora, Colorado, United States of America.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Thorsten', 'Affiliation': 'RTI International, Durham, North Carolina, United States of America.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'RTI International, Durham, North Carolina, United States of America.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Durham, North Carolina, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, North Carolina, United States of America.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania, United States of America.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Department of Obstetrics/Gynecology, Columbia University Medical Center, New York, New York, United States of America.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'NICHD/NIH, Rockville, Maryland, United States of America.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.""}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Pediatric Nutrition, University of Colorado School of Medicine, Aurora, Colorado, United States of America.'}]",PloS one,['10.1371/journal.pone.0218960']
408,32168208,Effect of Thyroxine Therapy on Depressive Symptoms Among Women With Subclinical Hypothyroidism.,"OBJECTIVE


To estimate the effect of antenatal treatment of subclinical hypothyroidism on maternal depressive symptoms.
METHODS


We conducted an ancillary study to a multicenter trial in women with singleton pregnancies diagnosed with subclinical hypothyroidism randomized to antenatal thyroxine therapy or placebo. Treatment was discontinued at the end of pregnancy. Women with overt thyroid disease, diabetes, autoimmune disease, and those diagnosed with depression were excluded. Participants were assessed for depressive symptoms using the Center for Epidemiological Studies-Depression scale (CES-D) before starting the study drug (between 11 and 20 weeks of gestation), between 32 and 38 weeks of gestation, and at 1 year postpartum. The primary outcome was maternal depressive symptoms score as assessed using the CES-D. Secondary outcome was the percentage of women who scored 16 or higher on the CES-D, as such a score is considered screen-positive for depression.
RESULTS


Two hundred forty-five (36.2% of parent trial) women with subclinical hypothyroidism were allocated to thyroxine (n=124) or placebo (n=121). Median CES-D scores and the proportion of participants with positive scores were similar at baseline between the two groups. Treatment with thyroxine was not associated with differences in CES-D scores (10 [5-15] vs 10 [5-17]; P=.46) or in odds of screening positive in the third trimester compared with placebo, even after adjusting for baseline scores (24.3% vs 30.1%, adjusted odds ratio 0.63, 95% CI 0.31-1.28, P=.20). At 1 year postpartum, CES-D scores were not different (6 [3-11] vs 6 [3-12]; P=.79), nor was the frequency of screen-positive CES-D scores in the treated compared with the placebo group (9.7% vs 15.8%; P=.19). Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores. Sensitivity analysis including women who were diagnosed with depression by the postpartum visit did not change the results.
CONCLUSIONS


This study did not achieve its planned sample size, thus our conclusions may be limited, but in this cohort of pregnant women with subclinical hypothyroidism, antenatal thyroxine replacement did not improve maternal depressive symptoms.",2020,Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores.,"['Women With Subclinical Hypothyroidism', 'women who were diagnosed with depression by the postpartum visit did not change the results', 'women with singleton pregnancies diagnosed with subclinical hypothyroidism randomized to', 'pregnant women with subclinical hypothyroidism', 'Women with overt thyroid disease, diabetes, autoimmune disease, and those diagnosed with depression were excluded', 'Two hundred forty-five (36.2% of parent trial) women with subclinical hypothyroidism']","['antenatal thyroxine therapy or placebo', 'thyroxine', 'Thyroxine Therapy', 'placebo']","['Depressive Symptoms', 'Median CES-D scores', 'maternal depressive symptoms', 'CES-D scores', 'frequency of screen-positive CES-D scores', 'maternal depressive symptoms score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0040128', 'cui_str': 'Thyroid Diseases'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0948465', 'cui_str': 'Thyroxine therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.699866,Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores.,"[{'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas, University of Texas - Southwestern, Dallas, Texas, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Wayne State University, Detroit, Michigan, Columbia University, New York, New York, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Alabama at Birmingham, Birmingham, Alabama; Brown University, Providence, Rhode Island, University of Texas - Houston, Houston, Texas, The Ohio State University, Columbus, Ohio, Case Western Reserve University, Cleveland, Ohio, Oregon Health Sciences University, Portland, Oregon, University of Pittsburgh, Pittsburgh, Pennsylvania, Medical University of South Carolina, Charleston, South Carolina; and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Boggess', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sibai', 'Affiliation': ''}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Mercer', 'Affiliation': ''}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': ''}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': ''}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'VanDorsten', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003724']
409,32227127,Evaluation of a Paradigm Shift From Intravenous Antibiotics to Oral Step-Down Therapy for the Treatment of Infective Endocarditis: A Narrative Review.,"Importance


The requirement of prolonged intravenous antibiotic courses to treat infective endocarditis (IE) is a time-honored dogma of medicine. However, numerous antibiotics are now available that achieve adequate levels in the blood after oral administration to kill bacteria. Moreover, prolonged intravenous antibiotic regimens are associated with high rates of adverse events. Accordingly, recent studies of oral step-down antibiotic treatment have stimulated a reevaluation of the need for intravenous-only therapy for IE.
Observations


PubMed was reviewed in October 2019, with an update in February 2020, to determine whether evidence supports the notion that oral step-down antibiotic therapy for IE is associated with inferior outcomes compared with intravenous-only therapy. The search identified 21 observational studies evaluating the effectiveness of oral antibiotics for treating IE, typically after an initial course of intravenous therapy; none found such oral step-down therapy to be inferior to intravenous-only therapy. Multiple studies described an improved clinical cure rate and an improved mortality rate among patients treated with oral step-down vs intravenous-only antibiotic therapy. Three randomized clinical trials also demonstrated that oral step-down antibiotic therapy is at least as effective as intravenous-only therapy in right-sided, left-sided, or prosthetic valve IE. In the largest trial, at 3.5 years of follow-up, patients randomized to receive oral step-down antibiotic therapy had a significantly improved cure rate and mortality rate compared with those who received intravenous-only therapy.
Conclusions and Relevance


This review found ample data demonstrating the therapeutic effectiveness of oral step-down vs intravenous-only antibiotic therapy for IE, and no contrary data were identified. The use of highly orally bioavailable antibiotics as step-down therapy for IE, after clearing bacteremia and achieving clinical stability with intravenous regimens, should be incorporated into clinical practice.",2020,"Three randomized clinical trials also demonstrated that oral step-down antibiotic therapy is at least as effective as intravenous-only therapy in right-sided, left-sided, or prosthetic valve IE.",['Infective Endocarditis'],"['Paradigm Shift From Intravenous Antibiotics to Oral Step-Down Therapy', 'oral antibiotics', 'oral step-down antibiotic therapy', 'oral step-down vs intravenous-only antibiotic therapy']","['cure rate and mortality rate', 'clinical cure rate', 'mortality rate']","[{'cui': 'C1541923', 'cui_str': 'Infective endocarditis (disorder)'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0372907,"Three randomized clinical trials also demonstrated that oral step-down antibiotic therapy is at least as effective as intravenous-only therapy in right-sided, left-sided, or prosthetic valve IE.","[{'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Spellberg', 'Affiliation': 'Los Angeles County + University of Southern California Medical Center, Los Angeles.'}, {'ForeName': 'Henry F', 'Initials': 'HF', 'LastName': 'Chambers', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Musher', 'Affiliation': 'Infectious Disease Section, Department of Medicine, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Walsh', 'Affiliation': 'Division of Infectious Diseases, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arnold S', 'Initials': 'AS', 'LastName': 'Bayer', 'Affiliation': 'Division of Infectious Diseases, The Lundquist Institute for Biomedical Innovation, Torrance, California.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0555']
410,30721941,A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial.,"Background


Reported benefits of maternal nutrition supplements commenced during pregnancy in low-resource populations have typically been quite limited.
Objectives


This study tested the effects on newborn size, especially length, of commencing nutrition supplements for women in low-resource populations ≥3 mo before conception (Arm 1), compared with the same supplement commenced late in the first trimester of pregnancy (Arm 2) or not at all (control Arm 3).
Methods


Women First was a 3-arm individualized randomized controlled trial (RCT). The intervention was a lipid-based micronutrient supplement; a protein-energy supplement was also provided if maternal body mass index (kg/m2) was <20 or gestational weight gain was less than recommendations. Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan. The primary outcome was length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery. Because gestational ages were unavailable in DRC, outcomes were determined for all 4 sites from WHO newborn standards (non-gestational-age-adjusted, NGAA) as well as INTERGROWTH-21st fetal standards (3 sites, gestational age-adjusted, GAA).
Results


A total of 7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes. Mean LAZ and other outcomes did not differ between Arm 1 and Arm 2 using either NGAA or GAA. Mean LAZ (NGAA) for Arm 1 was greater than for Arm 3 (effect size: +0.19; 95% CI: 0.08, 0.30, P = 0.0008). For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively). Rates of preterm birth did not differ among arms.
Conclusions


In low-resource populations, benefits on fetal growth-related birth outcomes were derived from nutrition supplements commenced before conception or late in the first trimester. This trial was registered at clinicaltrials.gov as NCT01883193.",2019,"For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively).","['women in low-resource populations ≥3 mo before conception (Arm 1', '7387 nonpregnant women were randomly assigned, yielding 2451 births with NGAA primary outcomes and 1465 with GAA outcomes', 'Study sites were in rural locations of the Democratic Republic of the Congo (DRC), Guatemala, India, and Pakistan']","['comprehensive maternal nutrition supplementation', 'maternal nutrition supplements']","['Mean LAZ (NGAA', 'length-for-age z score (LAZ), with all anthropometry obtained <48 h post delivery', 'rates of stunting and small-for-gestational-age', 'Rates of preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",7387.0,0.324382,"For GAA outcomes, rates of stunting and small-for-gestational-age were lower in Arm 1 than in Arm 3 (RR: 0.69; 95% CI: 0.49, 0.98, P = 0.0361 and RR: 0.78; 95% CI: 0.70, 0.88, P < 0.001, respectively).","[{'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Westcott', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garcés', 'Affiliation': 'INCAP (Instituto de Nutrición de Centro América y Panamá), Guatemala City, Guatemala.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'INCAP (Instituto de Nutrición de Centro América y Panamá), Guatemala City, Guatemala.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, India.""}, {'ForeName': 'Omrana', 'Initials': 'O', 'LastName': 'Pasha', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumera A', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Carl L', 'Initials': 'CL', 'LastName': 'Bose', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bauserman', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'National Institute of Child Health and Human Development/NIH, Bethesda, MD.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Thorsten', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Stolka', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqy228']
411,32215633,Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial.,"Importance


Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen.
Objective


To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States.
Design, Setting, and Participants


This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019.
Interventions


Mifepristone pretreatment plus misoprostol administration vs misoprostol alone.
Main Outcomes and Measures


Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated.
Results


Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815-0.0825] vs 0.0806 [95% CI, 0.0800-0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, -$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, -$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively.
Conclusions and Relevance


This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT02012491.",2020,The mifepristone pretreatment group had higher QALYs (0.0820,"['300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years', 'Participants included 300 women with anembryonic gestation or embryonic or fetal demise', '3 US sites from May 1, 2014, through April 30, 2017', 'Early Pregnancy']","['EPL with mifepristone pretreatment plus misoprostol vs misoprostol', 'mifepristone and misoprostol vs misoprostol', 'mifepristone pretreatment and misoprostol', 'EPL with mifepristone', 'mifepristone', 'Mifepristone pretreatment plus misoprostol administration vs misoprostol alone', 'Mifepristone', 'misoprostol']","['cost-effectiveness acceptability curves', 'cost-effective', 'societal perspective', 'higher completion rate', 'Cost-effectiveness', 'Incremental cost-effectiveness ratios (ICERs', 'Measures\n\n\nCosts in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy', 'mean costs']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4524250', 'cui_str': 'Anembryonic gestation'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",300.0,0.187961,The mifepristone pretreatment group had higher QALYs (0.0820,"[{'ForeName': 'Divyah', 'Initials': 'D', 'LastName': 'Nagendra', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Loza-Avalos', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Atrio', 'Affiliation': 'Department of Obstetrics and Gynecology, Montefiore Hospital, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Harvie', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1594']
412,31529452,Association Between Features of Spontaneous Late Preterm Labor and Late Preterm Birth.,"OBJECTIVE


This study aimed to evaluate the association between clinical and examination features at admission and late preterm birth.
STUDY DESIGN


The present study is a secondary analysis of a randomized trial of singleton pregnancies at 34 0/7  to 36 5/7  weeks' gestation. We included women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term). We calculated a statistical cut-point optimizing the sensitivity and specificity of initial cervical dilation and effacement at predicting preterm birth and used multivariable regression to identify factors associated with late preterm delivery.
RESULTS


A total of 431 out of 732 (59%) women delivered preterm. Cervical dilation ≥ 4 cm was 60% sensitive and 68% specific for late preterm birth. Cervical effacement ≥ 75% was 59% sensitive and 65% specific for late preterm birth. Earlier gestational age at randomization, nulliparity, and fetal malpresentation were associated with late preterm birth. The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and  p -value < 0.01).
CONCLUSION


Four in 10 women in late-preterm labor subsequently delivered at term. Combination of examination and clinical features (including parity and gestational age) improved late-preterm birth prediction.",2020,"The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and  p -value < 0.01).
","['A total of 431 out of 732 (59%) women delivered preterm', ""singleton pregnancies at 34 0/7  to 36 5/7  weeks' gestation"", 'women in spontaneous preterm labor with intact membranes and compared them by gestational age at delivery (preterm vs. term']",[],"['late-preterm birth prediction', 'late preterm birth prediction']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes (finding)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",431.0,0.248677,"The final regression model including clinical and examination features significantly improved late preterm birth prediction (81% sensitivity, 48% specificity, area under the curve = 0.72, 95% confidence interval [CI]: 0.68-0.75, and  p -value < 0.01).
","[{'ForeName': 'Angelica V', 'Initials': 'AV', 'LastName': 'Glover', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Battarbee', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, New York.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Boggess', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': 'George Washington University Biostatistics Center, Washington, District of Columbia.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': ""Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, Houston, Texas.""}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lucky', 'Initials': 'L', 'LastName': 'Jain', 'Affiliation': 'Department of Obstetrics and Gynecology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': 'Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': 'Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Erin A S', 'Initials': 'EAS', 'LastName': 'Clark', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Norton', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, California.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburg, Pittsburg, Pennsylvania.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Manuck', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of perinatology,['10.1055/s-0039-1696641']
413,31295916,Pregnant Women in Four Low-Middle Income Countries Have a High Prevalence of Inadequate Dietary Intakes That Are Improved by Dietary Diversity.,"BACKGROUND


Up-to-date dietary data are required to understand the diverse nutritional challenges of pregnant women living in low-middle income countries (LMIC). To that end, dietary data were collected from 1st trimester pregnant women in rural areas of Guatemala, India, Pakistan, and Democratic Republic of the Congo (DRC) participating in a maternal lipid-based nutrient supplement (LNS) Randomized Controlled Trial to examine dietary diversity (DD), usual group energy and nutrient intakes, and prevalence of inadequate dietary intakes.
METHODS


Two 24-h dietary recalls were conducted in ~240 pregnant women/site (total  n  = 966) prior to 12-week gestation. Adequate DD was assessed, i.e., ≥5 major food groups consumed within the past 24 h. Median, Q1, Q3 intakes (without LNS) of energy, macronutrients, 12 micronutrients, and phytate were examined. The ""at risk"" prevalence of inadequate intakes were based on international guidelines for pregnant women.
RESULTS


Dietary patterns varied widely among sites, with adequate DD reported: 20% (Pakistan), 25% (DRC), 50% (Guatemala), and 70% (India). Significantly higher intakes of most key nutrients were observed in participants with adequate DD. More than 80% of women in all sites had inadequate intakes of folate, vitamin B12, and choline, and >80% of women in India and DRC also had inadequate intakes of calcium, thiamine, riboflavin, and vitamin B6.
CONCLUSIONS


Our data highlight the likely need for micronutrient supplementation in pregnancy, specifically multi-micronutrient interventions, and support the value of increasing DD as part of sustainable long-term nutrition programs for women of reproductive age in these poor rural settings in LMIC.",2019,"More than 80% of women in all sites had inadequate intakes of folate, vitamin B12, and choline, and >80% of women in India and DRC also had inadequate intakes of calcium, thiamine, riboflavin, and vitamin B6.
","['Pregnant Women in Four Low-Middle Income Countries', 'pregnant women', '1st trimester pregnant women in rural areas of Guatemala, India, Pakistan, and Democratic Republic of the Congo (DRC) participating in a', '240 pregnant women/site (total  n  = 966) prior to 12-week gestation', 'pregnant women living in low-middle income countries (LMIC']","['maternal lipid-based nutrient supplement (LNS', 'dietary diversity (DD']","['inadequate intakes of folate, vitamin B12, and choline']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0032979', 'cui_str': 'Early Placental Phase'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'cyanocobalamin'}, {'cui': 'C0008405', 'cui_str': 'Choline'}]",966.0,0.0746971,"More than 80% of women in all sites had inadequate intakes of folate, vitamin B12, and choline, and >80% of women in India and DRC also had inadequate intakes of calcium, thiamine, riboflavin, and vitamin B6.
","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Lander', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado School of Medicine, Aurora, CO 80045, USA.'}, {'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado School of Medicine, Aurora, CO 80045, USA.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Westcott', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado School of Medicine, Aurora, CO 80045, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Tejeda', 'Affiliation': 'Maternal and Infant Health Center, INCAP (Institute of Nutrition for Central America and Panama), Guatemala City 01011, Guatemala.'}, {'ForeName': 'Tshilenge S', 'Initials': 'TS', 'LastName': 'Diba', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa BP8502, Democratic Republic of the Congo.'}, {'ForeName': 'Shivanand C', 'Initials': 'SC', 'LastName': 'Mastiholi', 'Affiliation': ""Women's and Children's Health Research, KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India.""}, {'ForeName': 'Umber S', 'Initials': 'US', 'LastName': 'Khan', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi 74800, Pakistan.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garcés', 'Affiliation': 'Maternal and Infant Health Center, INCAP (Institute of Nutrition for Central America and Panama), Guatemala City 01011, Guatemala.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'Maternal and Infant Health Center, INCAP (Institute of Nutrition for Central America and Panama), Guatemala City 01011, Guatemala.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Tshefu', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa BP8502, Democratic Republic of the Congo.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Lokangaka', 'Affiliation': 'Kinshasa School of Public Health, Kinshasa BP8502, Democratic Republic of the Congo.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research, KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India.""}, {'ForeName': 'Manjunath S', 'Initials': 'MS', 'LastName': 'Somannavar', 'Affiliation': ""Women's and Children's Health Research, KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India.""}, {'ForeName': 'Sumera Aziz', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi 74800, Pakistan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi 74800, Pakistan.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC 27709, USA.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics, Section of Nutrition, University of Colorado School of Medicine, Aurora, CO 80045, USA. nancy.krebs@ucdenver.edu.'}, {'ForeName': 'On Behalf Of The Women First Preconception Nutrition Trial', 'Initials': 'OBOTWFPNT', 'LastName': 'Group', 'Affiliation': ''}]",Nutrients,['10.3390/nu11071560']
414,32030417,Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial.,"BACKGROUND


Recent cardiovascular outcome trials have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease (CKD) in patients with type 2 diabetes at high cardiovascular risk. Whether these benefits extend to CKD patients without type 2 diabetes or cardiovascular disease is unknown. The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes.
METHODS


DAPA-CKD is a randomized, double-blind, placebo-controlled, trial in which ∼4300 patients with CKD Stages 2-4 and elevated urinary albumin excretion will be enrolled. The vast majority will be receiving a maximum tolerated dose of a renin-angiotensin system inhibitor at enrolment.
RESULTS


After a screening assessment, eligible patients with a urinary albumin:creatinine ratio ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 are randomly assigned to placebo or dapagliflozin 10 mg/day. Enrolment is monitored to ensure that at least 30% of patients do not have diabetes and that no more than 10% have an eGFR >60 mL/min/1.73 m2. The primary endpoint is a composite of a sustained decline in eGFR of ≥50%, end-stage renal disease, renal death or cardiovascular death. The trial will conclude when 681 primary renal events have occurred, providing 90% power to detect a 22% relative risk reduction (α level of 0.05).
CONCLUSION


DAPA-CKD will determine whether the SGLT2 inhibitor dapagliflozin, added to guideline-recommended therapies, safely reduces the rate of renal and cardiovascular events in patients across multiple CKD stages with and without diabetes.",2020,"The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes.
","['Chronic Kidney Disease (DAPA-CKD', 'patients with type 2 diabetes at high cardiovascular risk', '∼4300 patients with CKD Stages 2-4 and elevated urinary albumin excretion will be enrolled', 'patients across multiple CKD stages with and without diabetes', 'patients with CKD with and without diabetes', 'eligible patients with a urinary albumin:creatinine ratio ≥200\u2009mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75\u2009mL/min/1.73']","['sodium-glucose co-transporter 2 (SGLT2) inhibitors slow', 'placebo or dapagliflozin', 'placebo', 'SGLT2 inhibitor dapagliflozin', 'Dapagliflozin']","['rate of renal and cardiovascular events', 'composite of a sustained decline in eGFR of ≥50%, end-stage renal disease, renal death or cardiovascular death', 'renal and cardiovascular events']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2316786', 'cui_str': 'CKD stage 2'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C3811844'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",681.0,0.421981,"The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes.
","[{'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'National Institute of Medical Science and Nutrition Salvador Zubirán, Tlalpan, Mexico City, Mexico.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Greene', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Fan-Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Division of Nephrology, National Clinical Research Center for Kidney Disease, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation, Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'George Institute for Global Health, George Institute, Camperdown, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz290']
415,32401221,A Mobile Health App for the Collection of Functional Outcomes After Inpatient Stroke Rehabilitation: Pilot Randomized Controlled Trial.,"BACKGROUND


Monitoring the functional status of poststroke patients after they transition home is significant for rehabilitation. Mobile health (mHealth) technologies may provide an opportunity to reach and follow patients post discharge. However, the feasibility and validity of functional assessments administered by mHealth technologies are unknown.
OBJECTIVE


This study aimed to evaluate the feasibility, validity, and reliability of functional assessments administered through the videoconference function of a mobile phone-based app compared with administration through the telephone function in poststroke patients after rehabilitation hospitalization.
METHODS


A randomized controlled trial was conducted in a rehabilitation hospital in Southeast China. Participants were randomly assigned to either a videoconference follow-up (n=60) or a telephone follow-up (n=60) group. We measured the functional status of participants in each group at 2-week and 3-month follow-up periods. Half the participants in each group were followed by face-to-face home visit assessments as the gold standard. Validity was assessed by comparing any score differences between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Reliability was assessed by computing agreements between videoconference follow-up and home visit assessments, as well as telephone follow-up and home visit assessments. Feasibility was evaluated by the levels of completion, satisfaction, comfort, and confidence in the 2 groups.
RESULTS


Scores obtained from the videoconference follow-up were similar to those of the home visit assessment. However, most scores collected from telephone administration were higher than those of the home visit assessment. The agreement between videoconference follow-up and home visit assessments was higher than that between telephone follow-up and home visit assessments at all follow-up periods. In the telephone follow-up group, completion rates were 95% and 82% at 2-week and 3-month follow-up points, respectively. In the videoconference follow-up group, completion rates were 95% and 80% at 2-week and 3-month follow-up points, respectively. There were no differences in the completion rates between the 2 groups at all follow-up periods (X 2 1 =1.6, P=.21 for 2-week follow-up; X 2 1 =1.9, P=.17 for 3-month follow-up). Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up). The videoconference follow-up group demonstrated higher satisfaction than the telephone follow-up group at 3-month follow-up (X 2 3 =13.9; P=.03).
CONCLUSIONS


The videoconference follow-up assessment of functional status demonstrates higher validity and reliability, as well as higher confidence and satisfaction perceived by patients, than the telephone assessment. The videoconference assessment provides an efficient means of assessing functional outcomes of patients after hospital discharge. This method provides a novel solution for clinical trials requiring longitudinal assessments.
TRIAL REGISTRATION


chictr.org.cn: ChiCTR1900027626; http://www.chictr.org.cn/edit.aspx?pid=44831&htm=4.",2020,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","['patients after hospital discharge', 'rehabilitation hospital in Southeast China', 'poststroke patients after rehabilitation hospitalization']","['videoconference follow-up (n=60) or a telephone follow-up', 'mobile phone-based app compared with administration through the telephone function']","['Reliability', 'completion rates', 'higher satisfaction', 'levels of completion, satisfaction, comfort, and confidence', 'higher confidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0461705,"Patients in the videoconference follow-up group perceived higher confidence than those in the telephone follow-up group at both 2-week and 3-month follow-up periods (X 2 3 =6.7, P=.04 for 2-week follow-up; X 2 3 =8.0, P=.04 for 3-month follow-up).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Shanjia', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Guanli', 'Initials': 'G', 'LastName': 'Xie', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Chetwyn C H', 'Initials': 'CCH', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, HongKong, Hong Kong.'}, {'ForeName': 'Lidian', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, China.'}, {'ForeName': 'Alex W K', 'Initials': 'AWK', 'LastName': 'Wong', 'Affiliation': 'Program in Occupational Therapy, Washington University School of Medicine, St. Louis, MO, United States.'}]",JMIR mHealth and uHealth,['10.2196/17219']
416,32404035,Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups.,"Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction  P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction  P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.",2020,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","['patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with', 'older patients', 'patients with embolic stroke of undetermined source', 'Patients With Embolic Stroke of Undetermined Source', '5390 patients from December 2014 to January 2018']","['Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid', 'aspirin 100 mg once daily', 'Methods- RE-SPECT ESUS', 'Aspirin', ' and Purpose', 'dabigatran versus aspirin', 'aspirin', 'Conclusions', 'dabigatran']","['Stroke rates', 'Risks for major bleeding', 'recurrent stroke', 'rates of recurrent stroke and major bleeding', 'rate of recurrent stroke', 'bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",5390.0,0.375563,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL (R.A.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brainin', 'Affiliation': 'Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.).'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.).'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Gdovinová', 'Affiliation': 'Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.).'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Martins', 'Affiliation': 'Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.).'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Meyerhoff', 'Affiliation': 'Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).'}, {'ForeName': 'Truman', 'Initials': 'T', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.).'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Pfeilschifter', 'Affiliation': 'Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Reif', 'Affiliation': 'Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Rose', 'Affiliation': 'Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Šaňák', 'Affiliation': 'Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.).'}, {'ForeName': 'Wolf-Rüdiger', 'Initials': 'WR', 'LastName': 'Schäbitz', 'Affiliation': 'Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).'}]",Stroke,['10.1161/STROKEAHA.119.028643']
417,30447037,Effect of canagliflozin treatment on hepatic triglyceride content and glucose metabolism in patients with type 2 diabetes.,"AIM


To evaluate the impact of the sodium glucose co-transporter 2 inhibitor canagliflozin on intrahepatic triglyceride (IHTG) accumulation and its relationship to changes in body weight and glucose metabolism.
MATERIALS AND METHODS


In this double-blind, parallel-group, placebo-controlled, 24-week trial subjects with inadequately controlled type 2 diabetes mellitus (T2DM; HbA1c = 7.7% ± 0.7%) from two centres were randomly assigned (1:1) to canagliflozin 300 mg or placebo. We measured IHTG by proton-magnetic resonance spectroscopy (primary outcome), hepatic/muscle/adipose tissue insulin sensitivity during a 2-step euglycaemic insulin clamp, and beta-cell function during a mixed meal tolerance test. Analyses were per protocol.
RESULTS


Between 8 September 2014-13 June 2016, 56 patients were enrolled. Canagliflozin reduced HbA1c (placebo-subtracted change: -0.71% [-1.08; -0.33]) and body weight (-3.4% [-5.4; -1.4]; both P ≤ 0.001). A numerically larger absolute decrease in IHTG occurred with canagliflozin (-4.6% [-6.4; -2.7]) versus placebo (-2.4% [-4.2; -0.6]; P = 0.09). In patients with non-alcoholic fatty liver disease (n = 37), the decrease in IHTG was -6.9% (-9.5; -4.2) versus -3.8% (-6.3; -1.3; P = 0.05), and strongly correlated with the magnitude of weight loss (r = 0.69, P < 0.001). Body weight loss ≥5% with a ≥30% relative reduction in IHTG occurred more often with canagliflozin (38% vs. 7%, P = 0.009). Hepatic insulin sensitivity improved with canagliflozin (P < 0.01), but not muscle or adipose tissue insulin sensitivity. Beta-cell glucose sensitivity, insulin clearance, and disposition index improved more with canagliflozin (P < 0.05).
CONCLUSIONS


Canagliflozin improves hepatic insulin sensitivity and insulin secretion and clearance in patients with T2DM. IHTG decreases in proportion to the magnitude of body weight loss, which tended to be greater and occur more often with canagliflozin.",2019,"Hepatic insulin sensitivity improved with canagliflozin (P < 0.01), but not muscle or adipose tissue insulin sensitivity.","['Between 8 September 2014-13 June 2016, 56 patients were enrolled', '24-week trial subjects with inadequately controlled type 2 diabetes mellitus (T2DM; HbA1c\u2009= 7.7% ± 0.7%) from two centres', 'patients with type 2 diabetes', 'patients with T2DM']","['placebo', 'canagliflozin', 'canagliflozin 300\u2009mg or placebo', 'sodium glucose co-transporter 2 inhibitor canagliflozin', 'Canagliflozin']","['muscle or adipose tissue insulin sensitivity', 'hepatic insulin sensitivity and insulin secretion and clearance', 'weight loss', 'Body weight loss', 'intrahepatic triglyceride (IHTG) accumulation', 'Hepatic insulin sensitivity', 'Beta-cell glucose sensitivity, insulin clearance, and disposition index', 'hepatic triglyceride content and glucose metabolism', 'body weight loss', 'IHTG', 'body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C3556568', 'cui_str': 'canagliflozin 300 MG [Invokana]'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0743223', 'cui_str': 'Disposition (disposition)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",56.0,0.171618,"Hepatic insulin sensitivity improved with canagliflozin (P < 0.01), but not muscle or adipose tissue insulin sensitivity.","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Cusi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bril', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Barb', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Polidori', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, California.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Sha', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Farrell', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Nishanth E', 'Initials': 'NE', 'LastName': 'Sunny', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Srilaxmi', 'Initials': 'S', 'LastName': 'Kalavalapalli', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Pettus', 'Affiliation': 'VA San Diego Healthcare System and Department of Medicine, Division of Endocrinology and Metabolism, University of California, San Diego, California.'}, {'ForeName': 'Theodore P', 'Initials': 'TP', 'LastName': 'Ciaraldi', 'Affiliation': 'VA San Diego Healthcare System and Department of Medicine, Division of Endocrinology and Metabolism, University of California, San Diego, California.'}, {'ForeName': 'Sunder', 'Initials': 'S', 'LastName': 'Mudaliar', 'Affiliation': 'VA San Diego Healthcare System and Department of Medicine, Division of Endocrinology and Metabolism, University of California, San Diego, California.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Henry', 'Affiliation': 'VA San Diego Healthcare System and Department of Medicine, Division of Endocrinology and Metabolism, University of California, San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13584']
418,30456796,Glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in patients with type 2 diabetes undergoing non-cardiac surgery: A multicentre randomized clinical trial.,"AIMS


The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D.
MATERIALS AND METHODS


This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups.
RESULTS


Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 ± 2.6 vs 8.8 ± 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 ± 2.3 vs 8.7 ± 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 ± 2.6 vs 9.2 ± 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 ± 3.3 vs 3.1 ± 3.3, P < 0.001) compared to the basal-bolus group.
CONCLUSIONS


For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.",2019,"Linagliptin resulted in fewer hypoglycaemic events (1.6% vs. 11%, p=0.001, 86% relative risk reduction), similar supplemental insulin (and lower number of daily insulin injections (2.0±3.3 vs 3.1±3.3, p<0.001) compared to basal-bolus.
","['T2D patients undergoing non-cardiac surgery with admission blood glucose(BG) 7.8-22.2 mmol/L treated with diet, oral agents or total insulin dose(TDD) ≤0.5 units/kg/day to linagliptin(n=128) daily or basal-bolus(n=122) with glargine once daily and rapid-acting insulin before meals', 'hospitalized patients with type 2 diabetes (T2D', 'hospitalized surgical patients with T2D', 'patients with T2D undergoing non-cardiac surgery presenting with mild to moderate hyperglycaemia (BG <11.1 mmol/L', 'Patients with Type 2 Diabetes Undergoing Non-Cardiac Surgery']","['linagliptin', 'Linagliptin', 'supplemental insulin', 'incretin-based therapy instead of or complementary to insulin therapy', 'Basal-Bolus Insulin Regimen']","['Mean daily BG', 'mean daily BG', 'hypoglycaemic events', 'supplemental insulin (and lower number of daily insulin injections', 'glycaemic efficacy and safety', 'Glycaemic Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1532634', 'cui_str': 'Unit/kilogram/day'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0356365', 'cui_str': 'Insulin, Rapid-Acting'}, {'cui': 'C1550738', 'cui_str': 'Before meal (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1562292', 'cui_str': 'Glucose-Dependent Insulin-Releasing Hormone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.107985,"Linagliptin resulted in fewer hypoglycaemic events (1.6% vs. 11%, p=0.001, 86% relative risk reduction), similar supplemental insulin (and lower number of daily insulin injections (2.0±3.3 vs 3.1±3.3, p<0.001) compared to basal-bolus.
","[{'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rasouli', 'Affiliation': 'Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado-Denver, Denver, Colorado.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Alexanian', 'Affiliation': 'Division of Endocrinology, Diabetes and Nutrition, Department of Medicine, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Anzola', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Urrutia', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13587']
419,30614616,Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial.,"AIM


To evaluate the long-term efficacy and safety of ertugliflozin in adults with type 2 diabetes mellitus inadequately controlled on metformin.
MATERIALS AND METHODS


A 104-week Phase III, randomized double-blind study with a 26-week placebo-controlled period (Phase A) and a 78-week period (Phase B) where blinded glimepiride was added to non-rescued placebo participants with fasting fingerstick glucose ≥6.1 mmol/L. Results through week 104 are reported.
RESULTS


Mean (standard error) change in HbA1c from baseline was -0.7% (0.07) and -1.0% (0.07) at week 52; -0.6% (0.08) and -0.9% (0.08) at week 104 for ertugliflozin 5 and 15 mg. At week 52, 34.8% and 36.6% participants had HbA1c <7.0%, and 24.6% and 33.7% at week 104, for ertugliflozin 5 and 15 mg. Ertugliflozin reduced fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP) from baseline through week 104. The incidence of female genital mycotic infections (GMIs) was higher with ertugliflozin, and symptomatic hypoglycaemia was lower for ertugliflozin versus placebo/glimepiride. Minimal bone mineral density (BMD) changes were observed, similar to placebo/glimepiride, except at total hip where reduction in BMD was greater with ertugliflozin 15 mg versus placebo/glimepiride: difference in least squares means (95% CI) -0.50% (-0.95, -0.04) at week 52 and -0.84% (-1.44, -0.24) at week 104.
CONCLUSIONS


Ertugliflozin maintained improvements from baseline in HbA1c, FPG, body weight and SBP through week 104. Ertugliflozin was well tolerated, with non-clinically relevant changes in BMD. Compared with placebo/glimepiride, ertugliflozin increased female GMIs, but reduced the incidence of symptomatic hypoglycaemia. ClinicalTrials.gov Identifier: NCT02033889.",2019,"Ertugliflozin reduced fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP) from baseline through week 104.","['participants with fasting fingerstick glucose', 'adults with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus inadequately controlled with']","['placebo', 'Ertugliflozin', 'glimepiride', 'placebo/glimepiride, ertugliflozin', 'placebo/glimepiride', 'ertugliflozin', 'ertugliflozin versus placebo/glimepiride', 'metformin monotherapy']","['incidence of symptomatic hypoglycaemia', 'incidence of female genital mycotic infections (GMIs', 'Minimal bone mineral density (BMD) changes', 'BMD', 'HbA1c, FPG, body weight and SBP', 'symptomatic hypoglycaemia', 'Mean (standard error) change in HbA1c', 'fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP']","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0017421', 'cui_str': 'Genitals, Female'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.210192,"Ertugliflozin reduced fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP) from baseline through week 104.","[{'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Pfizer Deutschland GmbH, Berlin, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Charbonnel', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Goldman', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc., New York, New York.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Darekar', 'Affiliation': 'Pfizer Ltd., Tadworth, UK.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Lauring', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13631']
420,30802635,The Hand-Held Fan and the Calming Hand for People With Chronic Breathlessness: A Feasibility Trial.,"CONTEXT


The battery-operated hand-held fan (""fan"") and the Calming Hand (CH), a cognitive strategy, are interventions used in clinical practice to relieve chronic breathlessness.
OBJECTIVE


To test the feasibility of a Phase III randomized controlled trial (RCT) evaluating the impact of the fan and/or CH compared with exercise advice alone for the relief of chronic breathlessness due to respiratory conditions.
METHODS


A single-site, feasibility ""2 × 2"" factorial, nonblinded, mixed-methods RCT was performed. Participants randomly allocated to four groups: fan + exercise advice, CH + exercise advice, fan + CH + exercise advice, and exercise advice alone. Measures included recruitment, acceptability, data quality and study outcomes (baseline and day 28), modified Incremental Shuttle Walk Test (mISWT), recovery time from exertion-induced breathlessness, life-space questionnaire, General Self-Efficacy Scale, and breathlessness numerical rating scales. Willing participants and carers were interviewed at study end.
RESULTS


Recruitment/acceptability/data completion: 53 people were screened, 40 randomized and completed (mean age 72 years (SD 9.8), 70% male). There were few missing data (mISWT, n = 2). Recovery time (seconds) from exertion-induced breathlessness showed most improvement for the fan; mean reduction from baseline -33.5 vs. CH mean increase from baseline 5.7. This represents a recovery speed at day 28 (-20.4%) faster for the fan vs. 4.1% slower for the CH. Qualitative data indicated participants valued the faster recovery and identified the fan as a useful ""medical"" device but found the CH unhelpful.
CONCLUSION


A Phase III RCT is feasible. Mixed-methods data synthesis supports recovery time as a novel, meaningful outcome measure.",2019,Recovery time (seconds) from exertion-induced breathlessness showed most improvement for the fan; mean reduction from baseline -33.5 vs. CH mean increase from baseline 5.7.,"['Recruitment/acceptability/data completion: 53 people were screened, 40 randomized and completed (mean age 72\xa0years (SD 9.8), 70% male', 'People With Chronic Breathlessness']","['exercise advice alone', 'fan\xa0+\xa0exercise advice, CH\xa0+\xa0exercise advice, fan\xa0+\xa0CH\xa0+\xa0exercise advice, and exercise advice alone']","['Recovery time (seconds) from exertion-induced breathlessness', 'recruitment, acceptability, data quality and study outcomes (baseline and day 28), modified Incremental Shuttle Walk Test (mISWT), recovery time from exertion-induced breathlessness, life-space questionnaire, General Self-Efficacy Scale, and breathlessness numerical rating scales']","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441039', 'cui_str': 'Fan (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242483', 'cui_str': 'Data Quality'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}]",,0.155201,Recovery time (seconds) from exertion-induced breathlessness showed most improvement for the fan; mean reduction from baseline -33.5 vs. CH mean increase from baseline 5.7.,"[{'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Swan', 'Affiliation': 'Wolfson Palliative Care Research Centre, Allam Medical Building, Hull York Medical School (HYMS), University of Hull, Hull, UK. Electronic address: flavia.swan@hyms.ac.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'English', 'Affiliation': 'Dove House Hospice, Hull, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Allgar', 'Affiliation': 'Hull York Medical School (HYMS), Department of Health Sciences, University of York, Heslington, York, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Hart', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, Hull, UK.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School (HYMS), University of Hull, Hull, UK.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.02.017']
421,30853549,"A Fixed Nitrous Oxide and Oxygen Mixture for Analgesia in Children With Leukemia With Lumbar Puncture-induced Pain: A Randomized, Double-blind Controlled Trial.","CONTEXT


Leukemia is the most common cancer in the childhood population. Lumbar puncture (LP) plays central role in the diagnosis and treatment process, but options for analgesia are limited.
OBJECTIVES


The present study aims to evaluate the efficacy of a fixed N 2 O/O 2  mixture to reduce pain in children with leukemia during LP as compared with placebo.
METHODS


A double-blind, placebo-controlled, and randomized clinical trial involving children who needed LP for diagnosis or treatment was conducted in the pediatrics department of the General Hospital of Ningxia Medical University. Eligible patients were randomly assigned to inhale either a fixed N 2 O/O 2  mixture or O 2 . The primary endpoint was the maximal pain level felt by the patient during the procedure measured using a numerical rating scale (0-10).
RESULTS


One-hundred fourteen consecutive patients were enrolled in this study and randomized. Pain scores during the procedure showed a significant decrease in N 2 O/O 2  mixture-treated patients to 1.05 ± 1.40 versus 8.00 ± 2.13 in controls (P < 0.01). No serious adverse effects were attributed to N 2 O/O 2  mixture inhalation. Analysis of the satisfaction of patients receiving N 2 O/O 2  mixture indicated that medical staff were satisfied with this treatment.
CONCLUSIONS


This study demonstrated that self-administered fixed N 2 O/O 2  is efficient to reduce pain related to LP in children with leukemia.",2019,Pain scores during the procedure showed a significant decrease in N 2 O/O 2  mixture-treated patients to 1.05 ± 1.40 versus 8.00 ± 2.13 in controls (P < 0.01).,"['children who needed LP for diagnosis or treatment was conducted in the pediatrics department of the General Hospital of Ningxia Medical University', 'Children With Leukemia With Lumbar Puncture-induced Pain', 'children with leukemia during LP', 'children with leukemia', 'Eligible patients', 'One-hundred fourteen consecutive patients']","['Lumbar puncture (LP', 'fixed N 2 O/O 2  mixture', 'Fixed Nitrous Oxide and Oxygen Mixture for Analgesia', 'placebo']","['serious adverse effects', 'maximal pain level felt', 'pain', 'Pain scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0553794', 'cui_str': 'Diagnostic lumbar puncture (procedure)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",114.0,0.638825,Pain scores during the procedure showed a significant decrease in N 2 O/O 2  mixture-treated patients to 1.05 ± 1.40 versus 8.00 ± 2.13 in controls (P < 0.01).,"[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China; Ningxia Key Laboratory of Cerebrocranial Diseases, Department of Anatomy, Histology and Embryology, School of Basic Medical Sciences, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Chai', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ya-Liang', 'Initials': 'YL', 'LastName': 'Dai', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Hai-Xiang', 'Initials': 'HX', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jian-Qiang', 'Initials': 'JQ', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacology, Pharmaceutical Institute of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Xiang', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China. Electronic address: li_yuxiang@163.com.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.02.029']
422,32214296,"Efficacy of Hyalase Hydrodissection in the Treatment of Carpal Tunnel Syndrome: A Randomized, Double-Blind, Controlled, Clinical Trial.","BACKGROUND


Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, which results from median nerve compression. A lot of nonsurgical modalities are available for the management of mild to moderate situations. Local Hyalase hydrodissection (HD) of the entrapped median nerve could offer a desirable sustained symptom alleviation.
OBJECTIVES


To evaluate the clinical efficacy of Hyalase/saline solution carpal tunnel HD on pain, functional status, and nerve conduction in patients with CTS.
STUDY DESIGN


A randomized, double-blinded trial.
SETTING


Anesthesia, pain, and rheumatology clinics in a university hospital.
METHODS


Patients: 60 patients with CTS (> 6 months' duration).
INTERVENTION


patients were allocated equally into either group 1 (HD with Hyalase + 10 mL saline solution injection), or group 2 (HD with 10 mL saline solution only).
MEASUREMENTS


assessment of pain using Visual Analog Scale (VAS), functional disability (FD) score, and nerve conduction studies before injection, and over 6 months after injection. Nerve conduction parameters before injection and postinjection by the end of 3 and 6 months were evaluated as well.
RESULTS


Statistically significant lower postinjection values of VAS (1 ± 1.8, 2 ± 1.1, 2 ± 1.2, 2 ± 1.1) in group 1 versus (2 ± 1.2, 3 ± 1.7, 4 ± 1.5, 5 ± 2.6) in group 2 by the end of the first week, and the first, third, and sixth months, and significantly lower FD scores (15.3 ± 1.2, 13 ± 1.3, 10.2 ± 1.3, 10.2 ± 1.3) in group 1 versus (17.5 ± 1.8, 16.6 ± 2.8, 19.4 ± 3.2, 21.2 ± 2.5) in group 2 during the same time intervals. Nerve conduction study parameters have shown significantly higher velocity and lower latency in the Hyalase group than in the saline solution group by the 3 and 6 month follow-up.
LIMITATION


We suggest a longer period could be reasonable.
CONCLUSIONS


Carpal tunnel HD with Hyalase with saline solution is considered as an efficient technique offering a rapid onset of pain relief and functional improvements, and better median nerve conduction in patients with CTS over 6 months follow-up duration.
KEY WORDS


Carpal tunnel syndrome, Hyalase, median nerve hydrodissection.",2020,"Nerve conduction study parameters have shown significantly higher velocity and lower latency in the Hyalase group than in the saline solution group by the 3 and 6 month follow-up.
","['Anesthesia, pain, and rheumatology clinics in a university hospital', 'Carpal tunnel syndrome (CTS', 'Carpal Tunnel Syndrome', ""Patients: 60 patients with CTS (> 6 months' duration"", 'patients with CTS']","['Hyalase/saline solution carpal tunnel HD', 'group 1 (HD with Hyalase + 10 mL saline solution injection), or group 2 (HD with 10 mL saline solution only', 'Hyalase Hydrodissection']","['pain using Visual Analog Scale (VAS), functional disability (FD) score, and nerve conduction studies', 'pain, functional status, and nerve conduction', 'FD scores']","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3812871', 'cui_str': 'Rheumatology clinic'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0027788', 'cui_str': 'Nerve Conduction'}]",60.0,0.285248,"Nerve conduction study parameters have shown significantly higher velocity and lower latency in the Hyalase group than in the saline solution group by the 3 and 6 month follow-up.
","[{'ForeName': 'Abdelraheem', 'Initials': 'A', 'LastName': 'Elawamy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assuit University, Assiut, Egypt.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Hassanien', 'Affiliation': '1Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hamed', 'Affiliation': 'Rheumatology and Rehabilitation Department, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Al Shimaa Ismael', 'Initials': 'ASI', 'LastName': 'Roushdy', 'Affiliation': 'Anesthesia, Intensive Care, and Pain Management, Faculty of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Nisreen Adel', 'Initials': 'NA', 'LastName': 'Abass', 'Affiliation': 'Diagnostic Radiology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Mohammed', 'Affiliation': 'Anesthesia, Intensive Care, and Pain Management Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Raouf Abdel Razek', 'Initials': 'MRAR', 'LastName': 'Hasan', 'Affiliation': 'Department of Rheumatology and Rehabilitation, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Emad Zarief', 'Initials': 'EZ', 'LastName': 'Kamel', 'Affiliation': 'Assiut University, Assiut, Egypt.'}]",Pain physician,[]
423,32214297,Whole-Course Application of Dexmedetomidine Combined with Ketorolac in Nonnarcotic Postoperative Analgesia for Patients with Lung Cancer Undergoing Thoracoscopic Surgery: A Randomized Control Trial.,"BACKGROUND


Opioid-based postoperative analgesia provides adequate analgesia with much adverse effects and immunosuppression. Dexmedetomidine and ketorolac have properties of opioid-sparing, antiinflammation, and immune protection.
OBJECTIVES


To investigate the efficacy and safety of whole-course application of dexmedetomidine combined with ketorolac in nonnarcotic postoperative analgesia and its effect on inflammatory response and immune function in thoracoscopic surgery of lung cancer.
STUDY DESIGN


Double-blind, randomized control trial.
SETTING


The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
METHODS


Sixty patients scheduled for thoracoscopic surgery were enrolled and randomly divided into 2 groups to receive a combination of intraoperative usage of dexmedetomidine and postoperative patient-controlled intravenous analgesia of dexmedetomidine 0.1 µg/kg/h and ketorolac 3 mg/kg (DEX group) or only postoperative patient-controlled intravenous analgesia of sufentanil 1.5 µg/kg and ketorolac 3 mg/kg (SUF group) for 48 hours. Vital signs, postoperative Visual Analog Scale (VAS) score, Ramsay sedation score, patient-controlled analgesia pressing times, consumption of sufentanil and rescue drug, and complications were compared between the 2 groups. The levels of inflammatory factors and immune function were also compared.
RESULTS


A significant reduction in median blood pressures and heart rates within 48 hours after surgery and perioperative consumption of sufentanil were observed in the DEX group compared with the SUF group (P < 0.05). No statistically significant difference was found in VAS scores, patient-controlled analgesia pressing times, and rescue drug consumption between the 2 groups (P > 0.05). The incidence of nausea was significantly lower in the DEX group compared with the SUF group (P < 0.05). A significant decrease of interleukin (IL)-1 beta, IL-6, tumor necrosis factor (TNF)-alpha, and increased CD4+ and CD4+/CD8+ were observed in the DEX group compared with the SUF group at 24 and 48 hours after surgery (P < 0.05). There was no difference in the levels of CD8+ and natural killer cells between the 2 groups (P > 0.05).
LIMITATIONS


This study was limited by its sample size.
CONCLUSIONS


Whole-course application of dexmedetomidine combined with ketorolac in nonnarcotic postoperative analgesia provided adequate and safe postoperative analgesia, reduced sufentanil consumption, analgesia-related complications, alleviated inflammatory response, and immunosuppression compared with sufentanil-based analgesia in thoracoscopic surgery.
KEY WORDS


Dexmedetomidine, ketorolac, sufentanil, thoracoscopic surgery, postoperative analgesic, patient-controlled analgesia, inflammatory response, immune function.",2020,The incidence of nausea was significantly lower in the DEX group compared with the SUF group (P < 0.05).,"['Sixty patients scheduled for thoracoscopic surgery', 'Patients with Lung Cancer Undergoing Thoracoscopic Surgery', 'The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China', 'thoracoscopic surgery of lung cancer']","['DEX', 'Dexmedetomidine and ketorolac', 'SUF', 'dexmedetomidine', 'dexmedetomidine and postoperative patient-controlled intravenous analgesia of dexmedetomidine 0.1 µg/kg/h and ketorolac 3 mg/kg (DEX group) or only postoperative patient-controlled intravenous analgesia of sufentanil 1.5 µg/kg and ketorolac 3 mg/kg (SUF', 'Dexmedetomidine Combined with Ketorolac', 'dexmedetomidine combined with ketorolac', 'ketorolac', 'sufentanil-based analgesia', 'Dexmedetomidine, ketorolac, sufentanil']","['levels of CD8+ and natural killer cells', 'median blood pressures and heart rates', 'VAS scores, patient-controlled analgesia pressing times, and rescue drug consumption', 'nonnarcotic postoperative analgesia provided adequate and safe postoperative analgesia, reduced sufentanil consumption, analgesia-related complications, alleviated inflammatory response, and immunosuppression', 'efficacy and safety', 'perioperative consumption of sufentanil', 'interleukin (IL)-1 beta, IL-6, tumor necrosis factor (TNF)-alpha, and increased CD4+ and CD4+/CD8', ' thoracoscopic surgery, postoperative analgesic, patient-controlled analgesia, inflammatory response, immune function', 'inflammatory response and immune function', 'incidence of nausea', 'levels of inflammatory factors and immune function', 'Vital signs, postoperative Visual Analog Scale (VAS) score, Ramsay sedation score, patient-controlled analgesia pressing times, consumption of sufentanil and rescue drug, and complications']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021753', 'cui_str': 'Catabolin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0518766'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",60.0,0.188087,The incidence of nausea was significantly lower in the DEX group compared with the SUF group (P < 0.05).,"[{'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Fa-Chen', 'Initials': 'FC', 'LastName': 'Zhou', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Xin-Yu', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Run', 'Initials': 'R', 'LastName': 'Lv', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Qian-Hao', 'Initials': 'QH', 'LastName': 'Hou', 'Affiliation': 'Anesthesiology Department, Dalian Medical of University, Dalian, China; 3Department of Thoracic Surgery, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Qing-Ping', 'Initials': 'QP', 'LastName': 'Wen', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}]",Pain physician,[]
424,31633643,Improved Reduction of the Tibiofibular Syndesmosis With TightRope Compared With Screw Fixation: Results of a Randomized Controlled Study.,"OBJECTIVE


To compare the rate of malreduction after high fibular fractures associated with syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device.
DESIGN


Prospective randomized controlled multicenter trial.
SETTING


Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada.
PATIENTS/PARTICIPANTS


One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment.
METHODS


Open reduction of the syndesmosis was performed in all cases. Fixation was randomized to either TightRope (1 knotless TightRope, group T) or screw fixation (two 3.5-mm cortical positional screws placed across 3 cortices, group S). Surgical techniques and rehabilitation were standardized. All surgeons were trained or experienced in the use of the TightRope device. Follow-up was performed at 2 and 6 weeks, 3, 6, and 12 months.
MAIN OUTCOME MEASURE


Rate of malreduction based on bilateral ankle computed tomography scan results at 3 months after fixation. Secondary outcome measures included adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire. The estimated sample size required to detect a difference in reduction rate was 72 patients, but the estimated sample size required to detect a difference in functional outcome scores was 240 patients, suggesting the study was adequately powered for radiographic results only.
RESULTS


Overall, the rate of malreduction using screw fixation was 39% compared with 15% using TightRope fixation (P = 0.028, χ). Analysis of computed tomography results was performed using a 2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular). Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05). Group T syndesmoses also had greater diastasis compared with control limb (4.1 ± 1.3 vs. 3.3 ± 1.4 mm, P < 0.01) and less fibular medialization compared with group S (1.04 ± 1.8 vs. 0.3 ± 1.8 mm, P = 0.05). Functional outcome measures demonstrated significant improvements over time, but no differences between fixation groups. Foot and Ankle Disability Index scores at each time interval were 44 ± 22 (T) versus 45 ± 24 (S) (6 weeks), 76 ± 14 versus 73 ± 17 (3 months), 89 ± 10 versus 86 ± 13 (6 months), and 93 ± 9 versus 90 ± 14 (12 months) (all P > 0.2). The reoperation rate was higher in the screw group compared with TightRope (30% vs. 4%, P = 0.02) with the difference driven by the rate of implant removal.
CONCLUSIONS


Based on our results, the TightRope device seems to compare favorably with two, 3.5-mm, 3-cortex screw fixation for syndesmosis injuries.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05).","['Eleven academic and community hospitals including Level 1 and Level 2 trauma centers across Canada', 'One hundred three patients with OTA/AO 44-C injuries with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation were followed for 12 months after treatment']","['TightRope (1 knotless TightRope, group T) or screw fixation', 'Screw Fixation', '3-cortex screw fixation', 'syndesmosis injury treated with open reduction and internal fixation, with either 2 screws or 1 knotless TightRope device', 'TightRope']","['rate of implant removal', 'Foot and Ankle Disability Index scores', '2-mm translation or 10-degree rotation threshold for malreduction and included fibular translation (anterior, posterior); syndesmosis distance (anterior, posterior, and mid); medial compression; and rotation (fibular and articular', 'greater anterior translation', 'adverse events, reoperation, and validated functional outcomes including the EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire', 'reoperation rate', 'fibular medialization', 'rate of malreduction using screw fixation', 'Rate of malreduction based on bilateral ankle computed tomography scan results']","[{'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0036679', 'cui_str': 'Separation (morphologic abnormality)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0443157', 'cui_str': 'Bony (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2370853', 'cui_str': 'Open reduction (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0561946', 'cui_str': 'Removal of implant (procedure)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",240.0,0.152368,"Patients in group T had greater anterior translation (5.4 ± 1.8 mm) compared with the contralateral limb (4.3 ± 1.3 mm, P < 0.01) or group S (4.6 ± 1.5 mm, P = 0.05).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Prism', 'Initials': 'P', 'LastName': 'Schneider', 'Affiliation': 'Department of Orthopedic Surgery, Foothills Medical Centre, Calgary, AB, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': 'Abdel-Rahman', 'Initials': 'AR', 'LastName': 'Lawendy', 'Affiliation': 'Department of Orthopedic Surgery, London Health Sciences Centre, Victoria Hospital, London, ON Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001559']
425,31855057,JOIN for ME : Testing a Scalable Weight Control Intervention for Adolescents.,"Background:  The goal of this randomized controlled trial was to compare the relative effectiveness of a comprehensive lifestyle intervention delivered through the YMCA,  JOIN for ME , with an enhanced version of this program that included on-site supervised group physical activity and opportunities for peer support, in decreasing adolescent weight status.  Methods:  Sixty-six adolescents with BMI >85th percentile and absolute BMI <50 were randomly assigned to the  JOIN for ME  or the  JOIN for ME enhanced  program. Teens in both conditions attended 16 weekly, in-person group sessions, followed by four biweekly and four monthly maintenance sessions. The enhanced condition also included weekly, group-based physical activity sessions and challenges. Group sessions were led by YMCA coaches.  Results:  Groups did not differ at baseline by age (14.7 + 1.6 years), sex (60.6% female), racial/ethnic minority status (37.7%), or weight (53.0% with severe obesity). Retention was 91% at 16 weeks and 82% at 10 months. Controlling for minority status and sex, there were no significant group differences over time for BMI ( p  = 0.15), BMI  z -scores for age and sex (BMIz,  p  = 0.07), or percent overweight ( p  = 0.15). Across all participants, on average, BMI decreased by 1.4 kg/m 2 , BMIz decreased by 0.12, and percent overweight decreased by 8.8% at four months.  Conclusions:  There were no significant differences observed in primary outcomes for adolescents randomized to the standard and enhanced versions of the  JOIN for ME  program. Although the absence of a control condition precludes attribution to the intervention, teens in both conditions demonstrated greater decreases in weight status than what was observed in an open trial of the original program.",2020,There were no significant differences observed in primary outcomes for adolescents randomized to the standard and enhanced versions of the  JOIN for ME  program.,"['Sixty-six adolescents with BMI ', 'ME ', '85th percentile and absolute BMI <50', 'Groups did not differ at baseline by age (14.7\u2009+\u20091.6 years), sex (60.6% female), racial/ethnic minority status (37.7%), or weight (53.0% with severe obesity', 'Adolescents']","['comprehensive lifestyle intervention', 'Scalable Weight Control Intervention']","['time for BMI', 'BMI', 'weight status', 'BMIz', 'Retention']","[{'cui': 'C4517841', 'cui_str': 'Sixty-six'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",66.0,0.0265914,There were no significant differences observed in primary outcomes for adolescents randomized to the standard and enhanced versions of the  JOIN for ME  program.,"[{'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Jelalian', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'E Whitney', 'Initials': 'EW', 'LastName': 'Evans', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rancourt', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ranzenhofer', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Neta', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'YMCA of Greater Providence, Providence, RI.'}, {'ForeName': 'Chantelle', 'Initials': 'C', 'LastName': 'Hart', 'Affiliation': 'UnitedHealth Group, Minnetonka, MN.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Seifer', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Klinepier', 'Affiliation': 'UnitedHealth Group, Minnetonka, MN.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA.'}]",Childhood obesity (Print),['10.1089/chi.2019.0053']
426,31640153,Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial.,"The objective of this secondary analysis was to identify maternal characteristics that modified the effect of maternal supplements on newborn size. Participants included 1465 maternal-newborn dyads in Guatemala, India, and Pakistan. Supplementation commenced before conception (Arm 1) or late 1st trimester (Arm 2); Arm 3 received usual care. Characteristics included body mass index (BMI), stature, anemia, age, education, socio-economic status (SES), parity, and newborn sex. Newborn outcomes were  z -scores for length (LAZ), weight (WAZ), and weight to length ratio-for-age (WLRAZ). Mixed-effect regression models included treatment arm, effect modifier, and arm * effect modifier interaction as predictors, controlling for site, characteristics, and sex. Parity (para-0 vs. para ≥1), anemia (anemia/no anemia), and sex were significant effect modifiers. Effect size (95% CI) for Arm 1 vs. 3 was larger for para-0 vs. ≥1 for all outcomes (LAZ 0.56 (0.28, 0.84,  p  < 0.001); WAZ 0.45 (0.20, 0.07,  p  < 0.001); WLRAZ 0.52 (0.17, 0.88,  p  < 0.01) but only length for Arm 2 vs. 3. Corresponding effects for para ≥1 were >0.02. Arm 3  z -scores were all very low for para-0, but not para ≥1. Para-0 and anemia effect sizes for Arm 1 were > Arm 2 for WAZ and WLRAZ, but not LAZ. Arm 1 and 2 had higher WAZ for newborn boys vs. girls. Maternal nulliparity and anemia were associated with impaired fetal growth that was substantially improved by nutrition intervention, especially when commenced prior to conception.",2019,"Effect size (95% CI) for Arm 1 vs. 3 was larger for para-0 vs. ≥1 for all outcomes (LAZ 0.56 (0.28, 0.84,  p  < 0.001);","['newborn boys vs. girls', 'Participants included 1465 maternal-newborn dyads in Guatemala, India, and Pakistan']","['WLRAZ', 'maternal supplements', 'WAZ and WLRAZ', 'LAZ', 'WAZ', 'usual care']","['Maternal Characteristics Affect Fetal Growth Response', 'newborn size', 'anemia (anemia/no anemia', 'z -scores for length (LAZ), weight (WAZ), and weight to length ratio-for-age (WLRAZ', 'impaired fetal growth', 'Maternal nulliparity and anemia', 'body mass index (BMI), stature, anemia, age, education, socio-economic status (SES), parity, and newborn sex']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0337781', 'cui_str': 'Economic Status'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",1465.0,0.0778616,"Effect size (95% CI) for Arm 1 vs. 3 was larger for para-0 vs. ≥1 for all outcomes (LAZ 0.56 (0.28, 0.84,  p  < 0.001);","[{'ForeName': 'K Michael', 'Initials': 'KM', 'LastName': 'Hambidge', 'Affiliation': 'Section of Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA. Michael.Hambidge@cuanschutz.edu.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Durham, NC 27709, USA. cmb@rti.org.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC 27709, USA. mcclure@RTI.org.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Westcott', 'Affiliation': 'Section of Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA. Jamie.Westcott@cuanschutz.edu.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garcés', 'Affiliation': 'INCAP (Instituto de Nutrición de Centro América y Panamá), Guatemala City 01011, Guatemala. agarces@incap.int.'}, {'ForeName': 'Lester', 'Initials': 'L', 'LastName': 'Figueroa', 'Affiliation': 'INCAP (Instituto de Nutrición de Centro América y Panamá), Guatemala City 01011, Guatemala. lfigueroa@incap.int.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India. sgoudar@jnmc.edu.""}, {'ForeName': 'Sangappa M', 'Initials': 'SM', 'LastName': 'Dhaded', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India. drdhadedsm@gmail.com.""}, {'ForeName': 'Omrana', 'Initials': 'O', 'LastName': 'Pasha', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi 74800, Pakistan. omrana.pasha@jhu.edu.'}, {'ForeName': 'Sumera A', 'Initials': 'SA', 'LastName': 'Ali', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi 74800, Pakistan. sumera.ali@aku.edu.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Department of Global Affairs, Thomas Jefferson University, Philadelphia, PA 19107, USA. richard.derman@jefferson.edu.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University, New York, NY 10032, USA. rlg88@cumc.columbia.edu.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'NICHD/NIH, Bethesda, MD 20852, USA. kosomari@mail.nih.gov.'}, {'ForeName': 'Manjunath S', 'Initials': 'MS', 'LastName': 'Somannavar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India. manjunathsomannavar@gmail.com.""}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Herekar', 'Affiliation': ""KLE Academy of Higher Education and Research's Jawaharlal Nehru Medical College, Belagavi, Karnataka 590010, India. nandhari@gmail.com.""}, {'ForeName': 'Umber', 'Initials': 'U', 'LastName': 'Khan', 'Affiliation': 'Department of Community Health Sciences, Aga Khan University, Karachi 74800, Pakistan. umber.s.khan@googlemail.com.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'Section of Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO 80045, USA. Nancy.Krebs@cuanschutz.edu.'}]",Nutrients,['10.3390/nu11102534']
427,30851397,Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions.,"OBJECTIVE


Treatment for childhood anxiety disorders is insufficient in many cases. Parent involvement has been examined to augment child-based cognitive-behavioral therapy (CBT), but no studies have compared the efficacy of stand-alone parent-based treatment to CBT. Research implicates family accommodation in the maintenance and course of childhood anxiety. Supportive Parenting for Anxious Childhood Emotions (SPACE) is a parent-based treatment that reduces accommodation of childhood anxiety. This study compared SPACE to CBT in a noninferiority trial.
METHOD


Participants were children with primary anxiety disorders (N = 124; 7-14 years of age; 53% female participants; 83% white), randomly assigned to either SPACE (n = 64) with no direct child-therapist contact, or CBT (n = 60) with no parent treatment. A total of 97 participants (78%) completed all treatment sessions and assessments. Attrition did not differ significantly between groups. Primary anxiety outcomes included diagnostic interview and clinician-rated scales. Secondary outcomes included parent and child ratings of anxiety severity, family accommodation, and parenting stress. Noninferiority margins were determined based on statistical and clinical considerations. Change in family accommodation and parenting stress were examined using mixed models analyses.
RESULTS


SPACE was noninferior, relative to CBT, on primary and secondary anxiety outcomes, and based on ratings provided by independent evaluators, parents, and children. Family accommodation and parenting stress were significantly reduced in both treatments, with significantly greater reduction in family accommodation following SPACE compared to CBT. Treatment credibility and satisfaction were high.
CONCLUSION


SPACE is an acceptable and efficacious treatment for childhood anxiety disorders, is noninferior to CBT, and provides an alternative strategy for treating anxiety in children.
CLINICAL TRIAL REGISTRATION INFORMATION


Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE); https://clinicaltrials.gov; NCT02310152.",2020,"Family accommodation and parenting stress were significantly reduced in both treatments, with significantly greater reduction in family accommodation following SPACE compared to CBT.","['children', 'Participants were children with primary anxiety disorders (N\xa0= 124; 7-14 years of age; 53% female participants; 83% white', 'Anxious Childhood Emotions', 'n\xa0= 64) with no direct child-therapist contact, or CBT (n\xa0= 60) with no parent treatment', 'Childhood Anxiety', 'childhood anxiety disorders']","['SPACE', 'Supportive Parenting']","['diagnostic interview and clinician-rated scales', 'Attrition', 'Change in family accommodation and parenting stress', 'Family accommodation and parenting stress', 'parent and child ratings of anxiety severity, family accommodation, and parenting stress']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0000936', 'cui_str': 'Ocular Distance Accommodation'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",97.0,0.0334477,"Family accommodation and parenting stress were significantly reduced in both treatments, with significantly greater reduction in family accommodation following SPACE compared to CBT.","[{'ForeName': 'Eli R', 'Initials': 'ER', 'LastName': 'Lebowitz', 'Affiliation': 'Yale University Child Study Center, New Haven, CT. Electronic address: eli.lebowitz@yale.edu.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Marin', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Martino', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}, {'ForeName': 'Yaara', 'Initials': 'Y', 'LastName': 'Shimshoni', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Silverman', 'Affiliation': 'Yale University Child Study Center, New Haven, CT.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.02.014']
428,30917691,Pan-European Economic Analysis to Identify Cost Savings for the Health Care Systems as a Result of Integrating Glucose Monitoring Based Telemedical Approaches Into Diabetes Management.,"BACKGROUND


Self-monitoring of blood glucose supported by the diabetes-app OneTouch Reveal® has demonstrated to improve HbA1c. We aimed at analyzing costs savings related the integration of telemedical features into diabetes management.
METHODS


Data from a randomized controlled trial were used to assess the 10-year risk of patients for fatal myocardial infarction (MI). On the basis of this risk assessments-also related to a 5% or 10% reduction of hypoglycemic episodes-cost savings for the health care systems of five European countries-France, Germany, Italy, Spain, and the United Kingdom-were modeled.
RESULTS


HbA1c reduction of 0.92% in insulin-treated type 2 diabetes patients (T2DM) was associated with a 2.3% decreased 10-year risk for fatal MI. In combination with a 10% reduction of hypoglycemic events this risk reduction led to cost savings of €16.1 million (France), €57.8 million (Germany), €30.9 million (Italy), €23.8 million (Spain), and €5.8 million (UK), considering all insulin-treated T2DM patients in the respective countries.
CONCLUSION


Improving metabolic control and thus risk for comorbidities like MI by combining the glucose meter with CRI with telemedical features has the potential to reduce costs for European health care systems.",2019,"In combination with a 10% reduction of hypoglycemic events this risk reduction led to cost savings of €16.1 million (France), €57.8 million (Germany), €30.9 million (Italy), €23.8 million (Spain), and €5.8 million (UK), considering all insulin-treated T2DM patients in the respective countries.
",[],[],"['10-year risk of patients for fatal myocardial infarction (MI', '10-year risk for fatal MI', 'hypoglycemic events', 'HbA1c reduction']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0150079,"In combination with a 10% reduction of hypoglycemic events this risk reduction led to cost savings of €16.1 million (France), €57.8 million (Germany), €30.9 million (Italy), €23.8 million (Spain), and €5.8 million (UK), considering all insulin-treated T2DM patients in the respective countries.
","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Fritzen', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}, {'ForeName': 'Kornelia', 'Initials': 'K', 'LastName': 'Basinska', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Rubio-Almanza', 'Affiliation': 'Endocrinology and Nutrition Department Hospital Universitario y Politécnico La Fe and Instituto de Investigación Sanitaria La Fe, Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Nicolucci', 'Affiliation': 'Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kennon', 'Affiliation': 'FRCP, Diabetes Centre, Queen Elizabeth University Hospital, Glasgow, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vergès', 'Affiliation': 'Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition, Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Zakrzewska', 'Affiliation': 'LifeScan Europe GmbH, Zug, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Schnell', 'Affiliation': 'Sciarc GmbH, Baierbrunn, Germany.'}]",Journal of diabetes science and technology,['10.1177/1932296819835172']
429,31067999,Effect of Injection Site Cooling and Warming on Insulin Glargine Pharmacokinetics and Pharmacodynamics.,"BACKGROUND


In type 1 diabetes (T1D), closed-loop systems provide excellent overnight fasting blood glucose control by adjusting the insulin infusion rate based on corresponding changes in sensor glucose levels. In patients on multiple daily insulin (MDI) injections, such control in overnight glucose levels has not been possible due to the inability to alter the absorption rate of long-acting insulin after injection. In this study, we tested the hypothesis that increases/decreases of fasting glucose levels could be achieved by cooling/warming the skin around the injection site, which would result in lower/higher Glargine absorption rates from its subcutaneous depot.
METHODS


Fourteen subjects with T1D (4 females; age 39.6 ± 16.7 years, HbA1c 7.8 ± 1.1%, BMI 25.4 ± 2.8 kg/m 2 ) on MDI therapy underwent fasting pharmacokinetic and pharmacodynamic studies that started at ~8 am and lasted 240 min on 3 separate days in random order: a control day without warming or cooling of the injection site and two experimental days, one day with injection site warming and the other with cooling.
RESULTS


Cooling the skin around the glargine injection site reduced insulin concentrations by >40% ( P  < .01 versus the warming study,  P  = .21 versus the control study), accompanied by a 55 mg/dL increase in serum glucose ( P  < .01 versus the control study). Conversely, skin warming prevented the fall in serum insulin ( P  = .2 versus the control study;  P  < .01 versus the cooling study), resulting in a 40 mg/dL reduction in serum glucose ( P  < .001 versus the cooling study,  P  = .11 versus the control study).
CONCLUSIONS


This proof of concept study has shown that cooling and warming the skin around the injection site provides a means to decrease and increase the rate of absorption and action of insulin glargine from its subcutaneous depot.",2019,"Cooling the skin around the glargine injection site reduced insulin concentrations by >40% ( P < .01 versus the warming study, P = .21 versus the control study), accompanied by a 55 mg/dL increase in serum glucose ( P < .01 versus the control study).","['Fourteen subjects with T1D (4 females; age 39.6 ± 16.7 years, HbA1c 7.8 ± 1.1%, BMI 25.4 ± 2.8 kg/m 2 ) on MDI therapy underwent fasting pharmacokinetic and pharmacodynamic studies that started at ~8 am and lasted 240 min on 3 separate days in random order: a']","['Injection Site Cooling and Warming', 'control day without warming or cooling of the injection site and two experimental days, one day with injection site warming and the other with cooling']","['Insulin Glargine Pharmacokinetics and Pharmacodynamics', 'fall in serum insulin', 'serum glucose', 'rate of absorption and action of insulin glargine', 'Glargine absorption rates', 'insulin concentrations', 'fasting glucose levels']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}]","[{'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",14.0,0.021282,"Cooling the skin around the glargine injection site reduced insulin concentrations by >40% ( P < .01 versus the warming study, P = .21 versus the control study), accompanied by a 55 mg/dL increase in serum glucose ( P < .01 versus the control study).","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Bitton', 'Affiliation': 'Insuline Medical Ltd, Israel, Jerusalem, Israel.'}, {'ForeName': 'Vital', 'Initials': 'V', 'LastName': 'Rom', 'Affiliation': 'Insuline Medical Ltd, Israel, Jerusalem, Israel.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Hadelsberg', 'Affiliation': 'Insuline Medical Ltd, Israel, Jerusalem, Israel.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Tamborlane', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA.'}]",Journal of diabetes science and technology,['10.1177/1932296819842151']
430,32205111,Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training in a Pulsatile Model.,"OBJECTIVE


The current study assesses the feasibility of in vitro practice of percutaneous puncture techniques in a pulsatile flow-model.
DESIGN


Prospective, controlled, randomized study.
SETTING


The percutaneous access to endovascular aortic repair is considered safe, but success rates may be dependent on surgeon experience with the technique.
PARTICIPANTS


Fourteen vascular surgery trainees and consultants were enrolled and randomized to a study or control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device. The study group received additional hands-on training on a pulsatile flowmodel of the groin and the performance of both groups was then graded. Study group participants were timed during and after their training on the model.
RESULTS


The study group achieved higher overall grading than the control group on a 5-point scale with higher scores indicating a better performance (mean overall scores 4.0 ± 0.7 versus 2.8 ± 1.0, respectively; p = 0.03). Experienced participants (more than 20 punctures performed before the study) achieved higher overall scores than trainees (3.8 ± 0.4 versus 2.5 ± 0.8, respectively; p = 0.01). Five participants in the study group could deploy and close the ProGlide closure device correctly without the help of a tutor while being graded (71% in the study versus 0% in the control group; p = 0.02). Study group participants improved their overall score from 3.2 ± 0.9 to 4.0 ± 0.7 during training (p = 0.02). Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).
CONCLUSIONS


Study group participants could improve their overall score while working on the simulator. More experienced participants performed better during the simulation, which may indicate the model to be life-like and a potential skills assessment tool. Simulation training may be a valuable adjunct to traditional forms of training when teaching an endovascular technique but is limited by its reliance on simulators and demo devices.",2020,"Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).
",['Fourteen vascular surgery trainees and consultants'],"['Ultrasound-Guided Percutaneous Arterial Puncture and Closure Device Training', 'endovascular aortic repair', 'control group with both groups receiving instructions by a tutor on how to perform ultrasound guided percutaneous puncture and closure using a suture-mediated closure device', 'percutaneous puncture techniques', 'additional hands-on training', 'Simulation training']",['Time needed to complete the puncture and closure'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",,0.0439961,"Time needed to complete the puncture and closure reduced from 456 seconds on average before, to 302 seconds after training (p < 0.001).
","[{'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Taher', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria. Electronic address: fadi.taher@gmail.com.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Plimon', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Isaak', 'Affiliation': 'Department of Vascular and Endovascular Surgery, University Hospital Basel, Switzerland.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Falkensammer', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Eleonore', 'Initials': 'E', 'LastName': 'Pablik', 'Affiliation': 'Section for Medical Statistics - CeMSIIS, Medical University of Vienna, Austria.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Walter', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kliewer', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Assadian', 'Affiliation': 'Department of Vascular and Endovascular Surgery, Wilhelminenhospital, Vienna, Austria.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.032']
431,30778742,Two-Year Follow-Up of a Multi-centre Randomized Controlled Trial to Study Effectiveness of a Hospital-Based Work Support Intervention for Cancer Patients.,"Purpose Purpose is to: (1) study effectiveness of the hospital-based work support intervention for cancer patients at two years of follow-up compared to usual care and (2) identify which early factors predict time to return-to-work (RTW). Methods In this multi-center randomised controlled trial (RCT), 106 (self-)employed cancer patients were randomized to an intervention group or control group and provided 2 years of follow-up data. The intervention group received patient education and work-related support at the hospital. Primary outcome was RTW (rate and time) and quality of life (SF-36), and secondary outcomes were, work ability (WAI), and work functioning (WLQ). Univariate Cox regression analyses were performed to study which early factors predict time to full RTW. Results Participants were diagnosed with breast (61%), gynaecological cancer (35%), or other type of cancer (4%). RTW rates were 84% and 90% for intervention versus control group. They were high compared to national register-based studies. No differences between groups were found on any of the outcomes. Receiving chemotherapy (HR = 2.43, 95% CI 1.59-3.73 p < 0.001), low level of education (HR = 1.65, 95% CI 1.076-2.52 p = 0.02) and low work ability (HR = 1.09 [95% CI 1.04-1.17] p = 0.02) were associated with longer time to full RTW. Conclusions We found high RTW rates compared to national register-based studies and we found no differences between groups. Future studies should therefore focus on reaching the group at risk, which consist of patients who receive chemotherapy, have a low level of education and have a low work ability at diagnosis. TRIAL REGISTRATION: Netherlands Trial Registry (NTR) (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1658): NTR1658.",2019,No differences between groups were found on any of the outcomes.,"['106 (self-)employed cancer patients', 'Cancer Patients', 'cancer patients at two years of follow-up compared to usual care and (2) identify which early factors predict time to return-to-work (RTW', 'Participants were diagnosed with breast (61%), gynaecological cancer (35%), or other type of cancer (4']","['hospital-based work support intervention', 'intervention group or control group and provided 2 years of follow-up data', 'Hospital-Based Work Support Intervention', 'patient education and work-related support at the hospital']","['RTW rates', 'low work ability', 'longer time to full RTW', 'low level of education', 'RTW (rate and time) and quality of life (SF-36), and secondary outcomes were, work ability (WAI), and work functioning (WLQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034380'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.151454,No differences between groups were found on any of the outcomes.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Tamminga', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'J H A M', 'Initials': 'JHAM', 'LastName': 'Verbeek', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'M M E M', 'Initials': 'MMEM', 'LastName': 'Bos', 'Affiliation': 'Department of Internal Medicine, Reinier de Graaf Groep, Delft, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fons', 'Affiliation': 'Department of Gynaecology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'J J E M', 'Initials': 'JJEM', 'LastName': 'Kitzen', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Plaisier', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'M H W', 'Initials': 'MHW', 'LastName': 'Frings-Dresen', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'A G E M', 'Initials': 'AGEM', 'LastName': 'de Boer', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. a.g.deboer@amc.nl.'}]",Journal of occupational rehabilitation,['10.1007/s10926-019-09831-8']
432,30902431,Correcting astigmatism at the time of cataract surgery: Toric IOLs and corneal relaxing incisions planned with an image-guidance system and intraoperative aberrometer versus manual planning and surgery.,"PURPOSE


To compare the outcomes of the combination of an image-guided system and intraoperative aberrometer with the surgeon's standard of care in correcting astigmatism using toric intraocular lenses (IOLs) or corneal incisions.
SETTING


Single site in United States.
DESIGN


Prospective case series.
METHODS


Contralateral eyes of patients having uncomplicated bilateral cataract surgery and astigmatism correction were randomly assigned to Group A or Group B. Group A received the surgeon's preferred standard of care. Group B had preoperative planning using an image-guidance system (VERION), intraoperative aberrometry (ORA System with VerifEye+), and femtosecond laser-assisted cataract surgery. The primary endpoint was the residual refractive astigmatism at 3 months.
RESULTS


Thirty-eight eyes were treated with toric IOLs and 40 eyes with corneal astigmatic incisions. On average, toric IOLs resulted in almost 0.25 diopter (D) less cylinder than corneal astigmatic incisions (P < .01), with no difference between groups (P = .41). There was no statistically significant difference in the mean spherical equivalent refraction by group (P = .51). At 3 months, the IOL in 4 eyes (11%) (2 in Group A and Group B each) was more than 10 degrees of absolute orientation from the intended orientation. The mean keratometry was 0.16 D higher with the image-guided system compared with optical biometry (Lenstar). The vector difference between the 2 measurements was 0.5 D or lower in all eyes.
CONCLUSIONS


The combined use of an image-guided system and intraoperative aberrometer did not significantly improve outcomes compared with the surgeon's standard of care. Based on keratometry, there was good agreement in corneal astigmatism measurements between the image-guided system and the optical biometer.",2019,The combined use of an image-guided system and intraoperative aberrometer did not significantly improve outcomes compared with the surgeon's standard of care.,"['Thirty-eight eyes were treated with toric IOLs and 40 eyes with corneal astigmatic incisions', 'Single site in United States', 'Contralateral eyes of patients having uncomplicated bilateral cataract surgery and astigmatism correction']","['preoperative planning using an image-guidance system (VERION), intraoperative aberrometry (ORA System with VerifEye+), and femtosecond laser-assisted cataract surgery', ""image-guided system and intraoperative aberrometer with the surgeon's standard of care in correcting astigmatism using toric intraocular lenses (IOLs) or corneal incisions"", 'corneal relaxing incisions planned with an image-guidance system and intraoperative aberrometer versus manual planning and surgery']","['mean keratometry', 'residual refractive astigmatism', 'corneal astigmatism measurements', 'mean spherical equivalent refraction']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance procedure (procedure)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C2717991', 'cui_str': 'Aberrometry'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0730588', 'cui_str': 'AK - astigmatic keratotomy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0339682', 'cui_str': 'Corneal astigmatism'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}]",38.0,0.0567898,The combined use of an image-guided system and intraoperative aberrometer did not significantly improve outcomes compared with the surgeon's standard of care.,"[{'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mount Pleasant, South Carolina, USA. Electronic address: kerry.solomon@carolinaeyecare.com.'}, {'ForeName': 'Helga P', 'Initials': 'HP', 'LastName': 'Sandoval', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mount Pleasant, South Carolina, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Potvin', 'Affiliation': 'Science in Vision, Akron, New York, USA.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.12.002']
433,32214298,"Analgo-Sedative Effects of Oral or Nebulized Ketamine in Preschoolers Undergoing Elective Surgery: A Comparative, Randomized, Double-Blind Study.","BACKGROUND


Premedication in children with ketamine is useful to produce mild sedation, decrease anxiety, help the child separation from parents, and provide postoperative pain relief with no or little adverse effects.
OBJECTIVES


The aims of this study were to compare the level of sedation, parental separation, successful venous cannulation, and postoperative analgesia of oral or nebulized ketamine in preschoolers undergoing elective surgery.
STUDY DESIGN


A prospective, comparative, double-blind, randomized study.
SETTING


Zagazig University Hospitals.
METHODS


In the preparation room, 30 minutes before induction of anesthesia, 62 children were randomly divided into 2 groups: group O (n = 31) received oral ketamine 10 mg/kg in 2 mL apple juice, and group N (n = 31) received nebulized ketamine 3 mg/kg plus 2 mL isotonic saline solution by a standard hospital jet nebulizer via a mouth mask with a continuous 6 L/min flow of 100% oxygen.
RESULTS


At 10 minutes after premedication, sedation score was 3 in group O (34.4%) compared with group N (0%), and at 20 minutes in group O (93.5%) compared with group N (9.6%) (P < 0.001 ). However, at 30 minutes, 51.6% of group O showed a sedation score of 1 versus 0% of group N (P < 0.001 ). There were 70.9% of group O versus 6.4% of group N who showed an Emotional State Score of 1 (P < 0.0001), and 29.03% of group O versus 19.3% of group N who showed an Emotional State Score of 2 (P = 0.37), with statistically nonsignificant adverse effects in both groups. Low mean modified Children's Hospital of Eastern Ontario Pain Scale score in group O compared with group N at 30, 60, 90 minutes (P < 0.0001).
LIMITATIONS


In this study, although the dose of nebulized ketamine was 3 mg/kg, which was more than the optimum dose investigated in previous studies, it was not adequate, so we recommend conducting more studies investigating higher doses.
CONCLUSIONS


Oral ketamine 10 mg/kg as premedication 30 minutes before induction of anesthesia is more effective than 3 mg/kg nebulized ketamine in producing more sedation, satisfactory separation from parents, successful venous cannulation, and effective postoperative analgesia, as it is more tolerable and accepted by preschoolers undergoing elective surgery.
KEY WORDS


Nebulized ketamine, oral ketamine, preschooler, elective surgery.",2020,"There were 70.9% of group O versus 6.4% of group N who showed an Emotional State Score of 1 (P < 0.0001), and 29.03% of group O versus 19.3% of group N who showed an Emotional State Score of 2 (P = 0.37), with statistically nonsignificant adverse effects in both groups.","['Preschoolers Undergoing Elective Surgery', '62 children', 'Zagazig University Hospitals', 'children with', 'preschoolers undergoing elective surgery']","['oral ketamine 10 mg/kg in 2 mL apple juice', 'Nebulized ketamine, oral ketamine, preschooler, elective surgery', 'ketamine', 'nebulized ketamine', 'nebulized ketamine 3 mg/kg plus 2 mL isotonic saline solution by a standard hospital jet nebulizer via a mouth mask with a continuous 6 L/min flow of 100% oxygen', 'Oral or Nebulized Ketamine']","[""Low mean modified Children's Hospital of Eastern Ontario Pain Scale score"", 'sedation score', 'Emotional State Score']","[{'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",62.0,0.300902,"There were 70.9% of group O versus 6.4% of group N who showed an Emotional State Score of 1 (P < 0.0001), and 29.03% of group O versus 19.3% of group N who showed an Emotional State Score of 2 (P = 0.37), with statistically nonsignificant adverse effects in both groups.","[{'ForeName': 'Alshaimaa Abdel Fattah', 'Initials': 'AAF', 'LastName': 'Kamel', 'Affiliation': 'Anaesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}, {'ForeName': 'Olfat Abdelmoniem Ibrahem', 'Initials': 'OAI', 'LastName': 'Amin', 'Affiliation': 'Anaesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}]",Pain physician,[]
434,32214299,Comparison of Epidural Pressure Decrease Pattern According to Different Lumbar Epidural Approaches.,"BACKGROUND


During lumbar epidural injection (LEI) using a midline approach, we might encounter failure of identifying the epidural space owing to an equivocal or absent loss of resistance (LOR) sensation. The reason for such absence of LOR sensation has been suggested as paucity of midline ligamentum flavum, paravertebral muscle, and cyst in the interspinous ligament of the lumbar spine. Despite its low specificity, LOR is the most commonly used method to identify the epidural space.
OBJECTIVES


The purpose of this study was to analyze lumbar epidural pressure decrease patterns and identify factors contributing to this pressure decrease.
STUDY DESIGN


Prospective randomized trial.
SETTING


An interventional pain management practice in South Korea.
METHODS


This prospective study included 104 patients receiving LEI due to lumbar radiculopathy. A midline or paramedian approach of LEI was determined with randomization. Among various factors, gender, age, body mass index (BMI), and diagnosis were analyzed using a subgroup that included 60 cases of only a paramedian approach.
RESULTS


Grades I, II (abrupt decrease), and III (gradual decrease) were found as patterns of epidural pressure decrease. Abrupt pressure decrease was more frequently observed in the paramedian group (P < 0.001). Age, gender, BMI, and diagnosis did not show any significant difference in frequencies between abrupt and gradual pressure decrease.
LIMITATIONS


We could not match LOR sensation with epidural pressure decrease shown in the monitor.
CONCLUSIONS


This study demonstrates that abrupt pressure decrease occurs more frequently with the paramedian approach. However, age, gender, BMI, or diagnosis did not affect the incidence of epidural pressure decrease.
KEY WORDS


Epidural, paramedian, midline, pressure decrease.",2020,Abrupt pressure decrease was more frequently observed in the paramedian group (P < 0.001).,"['An interventional pain management practice in South Korea', '104 patients receiving LEI due to lumbar radiculopathy']",[],"['epidural pressure decrease', 'Abrupt pressure decrease']","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy (disorder)'}]",[],"[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",104.0,0.0337292,Abrupt pressure decrease was more frequently observed in the paramedian group (P < 0.001).,"[{'ForeName': 'Jiseob', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University School of Medicine, Republic of Korea.'}, {'ForeName': 'Sungwon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Keimyung University School of Medicine Republic of Korea.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University School of Medicine, Republic of Korea.'}, {'ForeName': 'JiHee', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Keimyung University School of Medicine, Republic of Korea.'}]",Pain physician,[]
435,32065623,"Clinical Effects of the Self-administered Subcutaneous Complement Inhibitor Zilucoplan in Patients With Moderate to Severe Generalized Myasthenia Gravis: Results of a Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial.","Importance


Many patients with generalized myasthenia gravis (gMG) have substantial clinical disability, persistent disease burden, and adverse effects attributable to chronic immunosuppression. Therefore, there is a significant need for targeted, well-tolerated therapies with the potential to improve disease control and enhance quality of life.
Objective


To evaluate the clinical effects of zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor of complement component 5, in a broad population of patients with moderate to severe gMG.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled phase 2 clinical trial at 25 study sites across North America recruited participants between December 2017 and August 2018. Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history.
Interventions


Patients were randomized 1:1:1 to a daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan for 12 weeks.
Main Outcomes and Measures


The primary and key secondary end points were the change from baseline to week 12 in QMG and MG Activities of Daily Living scores, respectively. Significance testing was prespecified at a 1-sided α of .10. Safety and tolerability were also assessed.
Results


The study of 44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables. The mean age of patients across all 3 treatment groups ranged from 45.5 to 54.6 years and most patients were white (average proportions across 3 treatment groups: 78.6%-86.7%). Clinically meaningful and statistically significant improvements in primary and key secondary efficacy end points were observed. Zilucoplan at a dose of 0.3 mg/kg SC daily resulted in a mean reduction from baseline of 6.0 points in the QMG score (placebo-corrected change, -2.8; P = .05) and 3.4 points in the MG Activities of Daily Living score (placebo-corrected change, -2.3; P = .04). Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores. Outcomes for the 0.1-mg/kg SC daily dose were also statistically significant but slower in onset and less pronounced than with the 0.3-mg/kg dose. Rescue therapy (intravenous immunoglobulin or plasma exchange) was required in 3 of 15, 1 of 15, and 0 of 14 participants in the placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan arms, respectively. Zilucoplan was observed to have a favorable safety and tolerability profile.
Conclusions and Relevance


Zilucoplan yielded rapid, meaningful, and sustained improvements over 12 weeks in a broad population of patients with moderate to severe AChR-Ab-positive gMG. Near-complete complement inhibition appeared superior to submaximal inhibition. The observed safety and tolerability profile of zilucoplan was favorable.
Trial Registration


ClinicalTrials.gov Identifier: NCT03315130.",2020,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","['44 patients was well balanced across the 3 treatment arms with respect to key demographic and disease-specific variables', 'Patients With Moderate to Severe Generalized Myasthenia Gravis', 'patients with generalized myasthenia gravis (gMG', '25 study sites across North America recruited participants between December 2017 and August 2018', 'Fifty-seven patients were screened, of whom 12 did not meet inclusion criteria and 1 was lost to follow-up after randomization but before receiving study drug, resulting in a total of 44 acetylcholine receptor autoantibody (AChR-Ab)-positive patients with gMG with baseline Quantitative Myasthenia Gravis (QMG) scores of at least 12, regardless of treatment history', 'patients with moderate to severe gMG']","['zilucoplan', 'placebo', 'zilucoplan, a subcutaneously (SC) self-administered macrocyclic peptide inhibitor', 'Self-administered Subcutaneous Complement Inhibitor Zilucoplan', 'daily SC self-injection of placebo, 0.1-mg/kg zilucoplan, or 0.3-mg/kg zilucoplan', 'Rescue therapy (intravenous immunoglobulin or plasma exchange', 'placebo, 0.1-mg/kg zilucoplan, and 0.3-mg/kg zilucoplan', 'Zilucoplan', 'Placebo']","['QMG and MG Activities of Daily Living scores', 'favorable safety and tolerability profile', 'MG Composite and MG Quality-of-Life scores', 'Daily Living score', 'QMG score', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0751339', 'cui_str': 'Myasthenia Gravis, Generalized'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0765796', 'cui_str': 'GMG'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034792', 'cui_str': 'Receptors, Acetylcholine'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1564892', 'cui_str': 'Complement Inactivating Agents'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",57.0,0.514858,"Clinically meaningful and statistically significant improvements were also observed in other secondary end points, the MG Composite and MG Quality-of-Life scores.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Barohn', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Dimachkie', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Farmakidis', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Colgan', 'Affiliation': 'University of Kansas, Fairway.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Benatar', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Tulio', 'Initials': 'T', 'LastName': 'Bertorini', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Pillai', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Henegar', 'Affiliation': 'Wesley Neurology Clinic, Cordova, Tennessee.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bromberg', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Gibson', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Janecki', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Freimer', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Bakri', 'Initials': 'B', 'LastName': 'Elsheikh', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Matisak', 'Affiliation': 'Ohio State University, Columbus.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genge', 'Affiliation': 'Montreal Neurological Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Guidon', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'David', 'Affiliation': 'Massachusetts General Hospital, Boston.'}, {'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Habib', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'University of California, Irvine, Orange.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Hinton', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hewitt', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Barnett', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Infirmary Health, Mobile, Alabama.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Ho', 'Affiliation': 'Lahey Hospital, Burlington, Massachusetts.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Howard', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Traub', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Chopra', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'Aly', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Bayat', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abu-Rub', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Shaida', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'University of Texas Southwestern, Dallas, Irving.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Lange', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Shara', 'Initials': 'S', 'LastName': 'Holzberg', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Khatri', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lindman', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Tayo', 'Initials': 'T', 'LastName': 'Olapo', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Sershon', 'Affiliation': 'Center for Neurological Disorders, St Francis Hospital at Ascension, Milwaukee, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lisak', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Bernitsas', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Jia', 'Affiliation': 'Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Tiffany D', 'Initials': 'TD', 'LastName': 'Lewis-Collins', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicolle', 'Affiliation': 'London Health Sciences Center, London, Ontario, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Roy', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nye', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Yasmeen', 'Initials': 'Y', 'LastName': 'Shabbir', 'Affiliation': 'University of Florida, Jacksonville.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sachdev', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Michigan State University, East Lansing.'}, {'ForeName': 'Zaeem', 'Initials': 'Z', 'LastName': 'Siddiqi', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sivak', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bratton', 'Affiliation': 'Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Small', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Anem', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fetter', 'Affiliation': 'Allegheny Neurological Associates, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Harvey', 'Affiliation': 'University of South Florida, Tampa.'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Silvestri', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Patrick', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Zakalik', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Petra W', 'Initials': 'PW', 'LastName': 'Duda', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'MacDougall', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Farzaneh-Far', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pontius', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hoarty', 'Affiliation': 'Ra Pharmaceuticals Inc, Cambridge, Massachusetts.'}]",JAMA neurology,['10.1001/jamaneurol.2019.5125']
436,31693069,Training Models for Implementing Evidence-Based Psychological Treatment: A Cluster-Randomized Trial in College Counseling Centers.,"Importance


Progress has been made in establishing evidence-based treatments for psychiatric disorders, but these are not often delivered in routine settings. A scalable solution for training clinicians in evidence-based treatments is needed.
Objective


To compare 2 methods of training college (university) counseling center therapists to treat psychiatric disorders using interpersonal psychotherapy. The hypothesis was that the train-the-trainer condition would demonstrate superior implementation outcomes vs the expert condition. Moderating factors were also explored.
Design, Setting, and Participants


This cluster-randomized trial was conducted from October 2012 to December 2017 in 24 college counseling centers across the United States. Therapist participants were recruited from enrolled centers, and student patients with symptoms of depression and eating disorders were recruited by therapists. Data were analyzed from 184 enrolled therapists.
Interventions


Counseling centers were randomized to the expert condition, which involved a workshop and 12 months of follow-up consultation, or the train-the-trainer condition, in which a staff member from the counseling center was coached to train other staff members.
Main Outcomes and Measures


The main outcome was therapist fidelity (adherence and competence) to interpersonal psychotherapy, as assessed via audio recordings of therapy sessions. Therapist knowledge of interpersonal psychotherapy was a secondary outcome.
Result


A total of 184 therapists (mean [SD] age, 41.9 [10.6] years; 140 female [76.1%]; 142 white [77.2%]) were included. Both the train-the-trainer-condition and expert-condition groups showed significant within-group improvement for adherence to interpersonal psychotherapy (change: 0.233 [95% CI, 0.192-0.274] and 0.190 [0.145-0.235], respectively; both P < .001), with large effect sizes (1.64 [95% CI, 1.35-1.93] and 1.34 [95% CI, 1.02-1.66], respectively) and no significant difference between conditions. Both groups also showed significant within-group improvement in interpersonal therapy competence (change: 0.179 [95% CI, 0.132-0.226] and 0.106 [0.059-0.153], respectively; both P < .001), with a large effect size for the train-the-trainer condition (1.16 [95% CI, 0.85-1.46]; P < .001) and a significant difference between groups favoring the train-the-trainer condition (effect size, 0.47 [95% CI, 0.05-0.89]; P = .03). Knowledge of interpersonal psychotherapy improved significantly within both groups (effect sizes: train-the-trainer, 0.64 [95% CI, 0.28-0.99]; P = .005; expert, 0.69 [95% CI, 0.38-1.01]; P < .001), with no significant difference between groups. The significant moderating factors were job satisfaction for adherence (b, 0.120 [95% CI, 0.001-0.24]; P = .048) and competence (b, 0.133 [95% CI, 0.001-0.27]; P = .048), and frequency of clinical supervision for competence (b, 0.05 [95% CI, 0.004-0.09]; P = .03).
Conclusions and Relevance


Results demonstrate that the train-the-trainer model produced training outcomes comparable with the expert model for adherence and was superior on competence. Given its potential capability to train more therapists over time, it has the potential to facilitate widespread dissemination of evidence-based treatments.
Trial Registration


ClinicalTrials.gov Identifier: NCT02079142.",2020,"Knowledge of interpersonal psychotherapy improved significantly within both groups (effect sizes: train-the-trainer, 0.64 [95% CI, 0.28-0.99]; P = .005; expert, 0.69 [95% CI, 0.38-1.01]; P < .001), with no significant difference between groups.","['A total of 184 therapists (mean [SD] age, 41.9 [10.6] years; 140 female [76.1%]; 142 white [77.2%]) were included', 'Therapist participants were recruited from enrolled centers, and student patients with symptoms of depression and eating disorders were recruited by therapists', 'College Counseling Centers', '184 enrolled therapists', 'October 2012 to December 2017 in 24 college counseling centers across the United States']","['training college (university) counseling center therapists', 'Training Models For Implementing Evidence-Based Psychological Treatment', 'interpersonal psychotherapy']","['Knowledge of interpersonal psychotherapy', 'interpersonal therapy competence', 'job satisfaction for adherence', 'therapist fidelity (adherence and competence) to interpersonal psychotherapy, as assessed via audio recordings of therapy sessions', 'frequency of clinical supervision for competence', 'adherence to interpersonal psychotherapy']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]",184.0,0.244149,"Knowledge of interpersonal psychotherapy improved significantly within both groups (effect sizes: train-the-trainer, 0.64 [95% CI, 0.28-0.99]; P = .005; expert, 0.69 [95% CI, 0.38-1.01]; P < .001), with no significant difference between groups.","[{'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'W Stewart', 'Initials': 'WS', 'LastName': 'Agras', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, Stanford, California.'}, {'ForeName': 'Ellen E', 'Initials': 'EE', 'LastName': 'Fitzsimmons-Craft', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Bohon', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, Stanford, California.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Eichen', 'Affiliation': 'Department of Pediatrics, University of California, San Diego.'}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Booil', 'Initials': 'B', 'LastName': 'Jo', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, Stanford, California.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Raghavan', 'Affiliation': 'School of Social Work, Rutgers, The State University of New Jersey, New Brunswick.'}, {'ForeName': 'Enola K', 'Initials': 'EK', 'LastName': 'Proctor', 'Affiliation': 'George Warren Brown School of Social Work, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'G Terence', 'Initials': 'GT', 'LastName': 'Wilson', 'Affiliation': 'Graduate School of Applied and Professional Psychology, Rutgers, The State University of New Jersey, Piscataway.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3483']
437,32108436,Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial.,"OBJECTIVE


To examine the safety and efficacy of abobotulinumtoxinA in patients previously treated with botulinum toxin type A (BoNT-A) products other than abobotulinumtoxinA.
DESIGN


Secondary analysis from a phase 3, double-blind, single-cycle, randomized, placebo-controlled study.
SETTING


Fifty-two centers (11 countries).
PATIENTS


Adults with spastic hemiparesis were randomized (1:1:1) to receive abobotulinumtoxinA 1000 U, 1500 U, or placebo in their affected lower limb.
MAIN OUTCOME MEASUREMENTS


Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1-point improvement); angle of catch (X V3  ) and spasticity grade (Y) for the GSC and soleus. Assessments were at weeks 1, 4, and 12 post-injection. Only descriptive statistics are presented.
RESULTS


Of 388 patients, 84 received previous BoNT-A treatment (abobotulinumtoxinA 1000 U: N = 30; abobotulinumtoxinA 1500 U: N = 28; placebo: N = 26). At week 4, mean (SD) changes in MAS score in the GSC were - 0.8 (1.1), -0.9 (1.0), and - 0.4 (0.7) for abobotulinumtoxinA 1000 U, 1500 U, and placebo, respectively. Greater MAS responder rates were observed for abobotulinumtoxinA versus placebo at all time points. Mean (SD) changes (week 4) for abobotulinumtoxinA 1000 U, 1500 U, and placebo for X V3  were: GSC, 8° (21), 6° (10) and 1° (7); soleus, 11° (21), 5° (9) and 0° (8), respectively; for Y: GSC, -0.4 (0.7), -0.6 (0.8) and - 0.0 (0.9); soleus, -0.5 (0.7), -0.5 (0.7) and - 0.1 (0.6), respectively. Safety data and adverse events were consistent with the overall known profile of abobotulinumtoxinA.
CONCLUSIONS


Patients previously treated with other BoNT-As showed improved muscle tone and spasticity at week 4 following abobotulinumtoxinA injection versus placebo. These findings suggest that abobotulinumtoxinA, at the recommended doses, has a good safety and efficacy profile in adults with lower limb spasticity who were previously treated with other BoNT-A products.",2020,Greater MAS responder rates were observed for abobotulinumtoxinA vs placebo at all time points.,"['adults with lower limb spasticity (LLS', '52 centers (11 countries', 'adults with LLS', 'hemiparesis in adults with lower limb spasticity previously treated with', 'patients previously treated with', '388 patients', 'Adults with spastic hemiparesis']","['abobotulinumtoxinA', 'placebo', 'abobotulinumtoxinA injection vs placebo', 'botulinum toxin type A (BoNT-A', 'abobotulinumtoxinA vs placebo', 'abobotulinumtoxinA 1500\u2009U: N\u2009=\u200928; placebo', 'previous BoNT-A treatment (abobotulinumtoxinA 1000\u2009U: N\u2009=\u200930', 'botulinum toxin', 'abobotulinumtoxinA 1000\u2009U, 1500\u2009U or placebo']","['Efficacy and safety', 'Safety data and adverse events', 'Mean (SD) changes', 'Muscle tone (6-point Modified Ashworth Scale [MAS], 0-5) for the gastrocnemius-soleus complex (GSC); proportion of MAS responders (≥1 point improvement); angle of catch (X V3  ) and spasticity grade (Y) for GSC and soleus', 'muscle tone and spasticity', 'Greater MAS responder rates', 'mean (SD) changes in MAS score in GSC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0154694', 'cui_str': 'Hemiplegia, Spastic'}]","[{'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0231617', 'cui_str': 'Catch (finding)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.582084,Greater MAS responder rates were observed for abobotulinumtoxinA vs placebo at all time points.,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, MossRehab Gait and Motion Analysis Laboratory, Elkins Park, PA, USA.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Stoquart', 'Affiliation': 'Physical and Rehabilitation Medicine Department, Cliniques universitaires Saint-Luc, Catholic University of Louvain, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Division of Movement Disorders, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Luis Jorge', 'Initials': 'LJ', 'LastName': 'Jacinto', 'Affiliation': 'Centro de Medicina de Reabilitação de Alcoitão, Estoril, Estoril, Portugal.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Dimanico', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Constant-Boyer', 'Affiliation': 'Unités de Médecine Physique et de Réadaptation, Hôpital Sébastopol, Université de Reims Champagne-Ardenne, Reims, France.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'School of Medicine, University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Grandoulier', 'Affiliation': 'Biostatistics, Ipsen Pharma, Les Ulis, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vilain', 'Affiliation': 'Medical Affairs, Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Medical Affairs, Les Ulis, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gracies', 'Affiliation': 'Service de Rééducation Neurolocomotrice, EA 7377 BIOTN, Université Paris-Est, Hospital Albert Chenevier-Henri Mondor, Créteil, France.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12348']
438,31815582,"Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of  ERCC1 : SWOG S1201.","PURPOSE


Platinum-based therapy is the standard of care in patients who have HER2-negative, advanced esophagogastric cancer (AEGC). Retrospective data suggest that intratumoral  ERCC1  levels may determine platinum sensitivity. A randomized, phase II study was performed in patients with AEGC to explore whether the efficacy of a platinum-based therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus a non-platinum-containing regimen of irinotecan and docetaxel (IT) differed according to  ERCC1  levels.
PATIENTS AND METHODS


Overall, 202 untreated patients with HER2-negative AEGC and a Zubrod performance status of 0-1 were evaluated prospectively for mRNA expression of  ERCC1  level and then randomly assigned to FOLFOX or IT, stratified by the intratumoral statuses of  ERCC1  low (< 1.7) or high (≥ 1.7). Objectives were to assess progression-free survival (PFS) and overall survival (OS) in all patients treated with FOLFOX compared with IT, stratified by low and high  ERCC1  levels, and to assess for interactive effects between  ERCC1  expression and treatment arm.
RESULTS


Eighty-six percent of patients had  ERCC1  values < 1.7. Thus, evaluation of the  ERCC1 -high subgroup was limited. Grade ≥ 3 anemia, dehydration, diarrhea, and fatigue were greater in patients with IT. Occurrences of grade ≥ 3 neuropathy and decreased neutrophils were greater in patients with FOLFOX. In all patients, FOLFOX had a statistically superior median PFS compared with IT (5.7  v  2.9 months; hazard ratio, 0.68;  P  = .02). In patients with  ERCC1  levels < 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
CONCLUSION


The evaluation of  ERCC1  in patients with upper GI tumors was thwarted by an overwhelming predominance of low  ERCC1  mRNA expression. Nonetheless, distribution of treatment effects on PFS did not vary with expression. For all patients and for those with low  ERCC1  expression, FOLFOX was superior in efficacy to IT.",2020,"< 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
","['patients with AEGC', 'patients who have HER2-negative, advanced esophagogastric cancer (AEGC', 'patients with  ERCC1  levels', 'patients with upper GI tumors', 'Overall, 202 untreated patients with HER2-negative AEGC and a Zubrod performance status of 0-1 were evaluated prospectively for mRNA expression of  ERCC1  level and then randomly assigned to FOLFOX or IT, stratified by the intratumoral statuses of  ERCC1  low (< 1.7) or high (≥ 1.7']","['FOLFOX', 'Platinum-based therapy', 'platinum-based therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus a non-platinum-containing regimen of irinotecan and docetaxel (IT']","['PFS and response rate', 'progression-free survival (PFS) and overall survival (OS', 'OS', '3 neuropathy and decreased neutrophils', 'Occurrences of grade ≥', 'Grade ≥ 3 anemia, dehydration, diarrhea, and fatigue', 'superior median PFS', 'Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1112160', 'cui_str': 'Gastrooesophageal cancer'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",202.0,0.0416042,"< 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
","[{'ForeName': 'Syma', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McDonough', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale University School of Medicine and Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Chaitali S', 'Initials': 'CS', 'LastName': 'Nangia', 'Affiliation': 'University of California Irvine, Orange, CA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'University of Pennsylvania, Newark, DE.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Dotan', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00925']
439,31939996,Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial.,"Importance


Left ventricular assist devices (LVADs) are well established in the treatment of advanced heart failure, but it is unclear whether outcomes are different based on the intended goal of therapy in patients who are eligible vs ineligible for heart transplant.
Objective


To determine whether clinical outcomes in the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) trial differed by preoperative categories of bridge to transplant (BTT) or bridge to transplant candidacy (BTC) vs destination therapy (DT).
Design, Setting, and Participants


This study was a prespecified secondary analysis of the MOMENTUM 3 trial, a multicenter randomized clinical trial comparing the magnetically levitated centrifugal-flow HeartMate 3 (HM3) LVAD to the axial-flow HeartMate II (HMII) pump. It was conducted in 69 centers with expertise in managing patients with advanced heart failure in the United States. Patients with advanced heart failure were randomized to an LVAD, irrespective of the intended goal of therapy (BTT/BTC or DT).
Main Outcomes and Measures


The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years. Secondary end points included adverse events, functional status, and quality of life.
Results


Of the 1020 patients with implants (515 with HM3 devices [50.5%] and 505 with HMII devices [49.5%]), 396 (38.8%) were in the BTT/BTC group (mean [SD] age, 55 [12] years; 310 men [78.3%]) and 624 (61.2%) in the DT group (mean [SD] age, 63 [12] years; 513 men [82.2%]). Of the patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant. In the primary end point analysis, HM3 use was superior to HMII use in patients in the BTT/BTC group (76.8% vs 67.3% for survival free of disabling stroke and reoperation; hazard ratio, 0.62 [95% CI, 0.40-0.94]; log-rank P = .02) and patients in the DT group (73.2% vs 58.7%; hazard ratio, 0.61 [95% CI, 0.46-0.81]; log-rank P < .001). For patients in both BTT/BTC and DT groups, there were not significantly different reductions in rates of pump thrombosis, stroke, and gastrointestinal bleeding with HM3 use relative to HMII use. Improvements in quality of life and functional capacity for either pump were not significantly different regardless of preimplant strategy.
Conclusions and Relevance


In this trial, the superior treatment effect of HM3 over HMII was similar for patients in the BTT/BTC or DT groups. It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure.
Trial Registration


ClinicalTrials.gov identifier: NCT02224755.",2020,The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years.,"['patients with medically refractory heart failure', '1020 patients with implants', 'Patients with advanced heart failure', 'Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3', 'Transplant or Destination Therapy Intent', '69 centers with expertise in managing patients with advanced heart failure in the United States', 'patients who are eligible vs ineligible for heart transplant', 'patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant']","['magnetically levitated centrifugal-flow HeartMate 3 (HM3) LVAD to the axial-flow HeartMate II (HMII) pump', 'Importance\n\n\nLeft ventricular assist devices (LVADs', 'LVAD', 'bridge to transplant (BTT) or bridge to transplant candidacy (BTC) vs destination therapy (DT', 'MagLev Technology']","['quality of life and functional capacity', 'survival free of disabling stroke or reoperation to remove or replace a malfunctioning device', 'rates of pump thrombosis, stroke, and gastrointestinal bleeding', 'adverse events, functional status, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1281998', 'cui_str': 'Refractory heart failure'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4517559', 'cui_str': '13.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1301962', 'cui_str': 'Centrifugal'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0034380'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",1020.0,0.181435,The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Goldstein', 'Affiliation': 'Montefiore Einstein Center for Heart and Vascular Care, New York, New York.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Naka', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York-Presbyterian Hospital, New York.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Horstmanshof', 'Affiliation': 'INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Ashwin K', 'Initials': 'AK', 'LastName': 'Ravichandran', 'Affiliation': 'St Vincent Heart Center, Indianapolis, Indiana.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schroder', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ransom', 'Affiliation': 'Baptist Health Medical Center, Little Rock, Arkansas.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Itoh', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Uriel', 'Affiliation': 'Columbia University College of Physicians and Surgeons, New York-Presbyterian Hospital, New York.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cleveland', 'Affiliation': 'University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Nirav Y', 'Initials': 'NY', 'LastName': 'Raval', 'Affiliation': 'Advent Health Transplant Institute, Orlando, Florida.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cogswell', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Erik E', 'Initials': 'EE', 'LastName': 'Suarez', 'Affiliation': 'Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Lowes', 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Pritzker School of Medicine, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Bonde', 'Affiliation': 'Yale Medical School, New Haven, Connecticut.'}, {'ForeName': 'Farooq H', 'Initials': 'FH', 'LastName': 'Sheikh', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Poornima', 'Initials': 'P', 'LastName': 'Sood', 'Affiliation': 'Abbott Laboratories, Abbott Park, Illinois.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Farrar', 'Affiliation': 'Abbott Laboratories, Abbott Park, Illinois.'}, {'ForeName': 'Mandeep R', 'Initials': 'MR', 'LastName': 'Mehra', 'Affiliation': ""Heart and Vascular Center, Center for Advanced Heart Disease, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.5323']
440,31373882,Feasibility of text messaging to augment brief advice and nicotine replacement therapy for smoking cessation in college students.,"Objective:  To test the feasibility of a university health center-delivered smoking cessation intervention that adds a 6-week course of text messaging to brief advice and nicotine patch therapy.  Participants : Young adult cigarette smokers ( n  = 40) from 2 universities from January 2015 to May 2016.  Methods : Randomized controlled trial comparing brief advice, nicotine patch therapy and: (1) a 6-week text messaging intervention ( n  = 20); or (2) no text messaging ( n  = 20). Primary outcomes included enrollment, retention and satisfaction.  Results:  Forty participants enrolled (38% of those screened). Retention rates were 98% and 92.5% at 6 and 12 weeks. Of those who completed the text intervention ( n  = 16), 64.3% felt the texts were ""helpful"", however they reported desire for tailoring and concern that texts triggered smoking. Biochemically confirmed abstinence rates did not significantly differ between text and control arms.  Conclusions : These feasibility data suggest that text messaging may need to be modified to better engage and motivate college-age smokers.",2019,Biochemically confirmed abstinence rates did not significantly differ between text and control arms.  ,"['Young adult cigarette smokers ( n \u2009=\u200940) from 2 universities from January 2015 to May 2016', 'college students', 'Participants ', 'Forty participants enrolled (38% of those screened']","['university health center-delivered smoking cessation intervention', 'nicotine replacement therapy', 'nicotine patch therapy and: (1) a 6-week text messaging intervention ( n \u2009=\u200920); or (2) no text messaging', 'text messaging', 'nicotine patch therapy']","['abstinence rates', 'enrollment, retention and satisfaction', 'Retention rates']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",40.0,0.077974,Biochemically confirmed abstinence rates did not significantly differ between text and control arms.  ,"[{'ForeName': 'Deepa R', 'Initials': 'DR', 'LastName': 'Camenga', 'Affiliation': 'a Department of Emergency Medicine, Yale University School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Bernstein', 'Affiliation': 'a Department of Emergency Medicine, Yale University School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'a Department of Emergency Medicine, Yale University School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Fiellin', 'Affiliation': 'b Department of Internal Medicine & Yale Child Study Center, Yale University School of Medicine , New Haven , CT , USA.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'c Department of Psychiatry, Yale University School of Medicine , New Haven , CT , USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2019.1643730']
441,27255082,The global network antenatal corticosteroids trial: impact on stillbirth.,"BACKGROUND


Antenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention.
METHODS


The ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5(th) percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth.
RESULTS


After adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters.
CONCLUSIONS


In this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial.
TRIAL REGISTRATION


clinicaltrials.gov (NCT01084096).",2016,"Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters.","['102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk']",[],"['stillbirth', 'risk of stillbirth', 'stillbirth rates', 'stillbirth rate', 'rate of stillbirth', 'maternal infection', '28-day neonatal mortality and stillbirth', 'neonatal mortality']","[{'cui': 'C0035168'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",[],"[{'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0239997', 'cui_str': 'Maternal infection'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.212306,"Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Goldenberg', 'Affiliation': 'Columbia University, New York, NY, USA. rlg@columbia.edu.'}, {'ForeName': 'Vanessa R', 'Initials': 'VR', 'LastName': 'Thorsten', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': 'IECS, Buenos Aires, Argentina.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garces', 'Affiliation': ', Guatemala, Guatemala.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Omrana', 'Initials': 'O', 'LastName': 'Pasha', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Elwyn', 'Initials': 'E', 'LastName': 'Chomba', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Shivaprasad', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""KLE University's JN Medical College,, Belgaum, India.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Esamai', 'Affiliation': 'Moi University, Eldoret, Kenya.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Krebs', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Christiana Care, Newark, DE, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Liechty', 'Affiliation': 'Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Lata Medical Research Foundation, Nagpur, India.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Hibberd', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Pierre M', 'Initials': 'PM', 'LastName': 'Buekens', 'Affiliation': 'Tulane School of Public Health and Tropical Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Koso-Thomas', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Menachem', 'Initials': 'M', 'LastName': 'Miodovnik', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Jobe', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Dennis D', 'Initials': 'DD', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Durham, NC, USA.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Belizán', 'Affiliation': 'IECS, Buenos Aires, Argentina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'McClure', 'Affiliation': 'RTI International, Durham, NC, USA.'}]",Reproductive health,['10.1186/s12978-016-0174-4']
442,32033793,Mortality and Neurodevelopmental Outcomes in the Heart Rate Characteristics Monitoring Randomized Controlled Trial.,"OBJECTIVE


To test whether the composite outcome of death or neurodevelopmental impairment (NDI) at 18-22 months corrected age for infants ≤1000 g at birth is decreased by continuous monitoring of heart rate characteristics during neonatal intensive care.
STUDY DESIGN


We studied a subset of participants enrolled in a multicenter randomized trial of heart rate characteristics monitoring. Survivors were evaluated at 18-22 months corrected age with a standardized neurologic examination and the Bayley Scales of Infant Development-III (BSID-III). NDI was defined as Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness.
RESULTS


The composite outcome, death or NDI, was obtained for 628 of 884 study infants (72%). The prevalence of this outcome was 44.4% (136/306) among controls (infants randomized to heart rate characteristics monitored but not displayed) and 38.9% (125/322) among infants randomized to heart rate characteristics monitoring displayed (relative risk, 0.87; 95% CI, 0.73-1.05; P = .17). Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028). The composite outcomes of death or severe CP and death or mildly low Bayley cognitive score occurred less frequently in the displayed group (P < .05).
CONCLUSIONS


We found no difference in the composite outcome of death or NDI for extremely preterm infants whose heart rate characteristics were and were not displayed during neonatal intensive care. Two outcomes that included mortality or a specific NDI were less frequent in the displayed group.",2020,"Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028).",['death or neurodevelopmental impairment (NDI) at 18-22\xa0months corrected age for infants ≤1000'],[],"['mortality or a specific NDI', 'Mortality and Neurodevelopmental Outcomes', 'death or NDI', 'death or severe CP and death or mildly low Bayley cognitive score', 'standardized neurologic examination and the Bayley Scales of Infant Development-III', 'Gross Motor Function Classification System of >2 (moderate or severe cerebral palsy), BSID-III language or cognitive scores of <70, severe bilateral hearing impairment, and/or bilateral blindness', 'Mortality', 'composite outcome of death or NDI']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027853', 'cui_str': 'Neurological Examination'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1879328', 'cui_str': 'Blindness, Complete'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",884.0,0.263847,"Mortality was reduced from 32.0% (99/307) among controls to 24.8% (81/326) among monitoring displayed infants (relative risk, 0.75; 95% CI, 0.59 to 0.97; P = .028).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, Oregon Health and Science University, Portland, OR. Electronic address: schelonk@ohsu.edu.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Bauer', 'Affiliation': 'Department of Pediatrics, University of Miami, Coral Gables, FL.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Peralta-Carcelen', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Helderman', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Christina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'J Randall', 'Initials': 'JR', 'LastName': 'Moorman', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kattwinkel', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'Department of Pediatrics and Medicine, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Pediatrics, University of North Carolina, Chapel Hill, NC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.066']
443,32037149,Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams.,"OBJECTIVES


To determine the effect of bovine lactoferrin on prevention of late-onset sepsis (LOS) and neurodevelopment delay.
STUDY DESIGN


Randomized, double-blind, controlled trial in neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing bovine lactoferrin 200 mg/kg/day with placebo administered for 8 weeks. The primary outcome was the first episode of culture-proven LOS or sepsis-associated death. Neurodevelopment delay was assessed by the Mullen Scales at 24 months corrected age.
RESULTS


Of the 414 infants enrolled, 209 received bovine lactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovine lactoferrin group vs 30 (14.6%) in the placebo group; there was no difference after adjusting for hospital and birth weight; hazard ratio 0.73 (95% CI, 0.42-1.26). For infants with birth weights of <1500 g the hazard ratio was 0.69 (95% CI, 0.39-1.25). The mean age-adjusted normalized Mullen composite score at 24 months was 83.3 ± 13.6 in the bovine lactoferrin group vs 82.6 ± 13.1 in the placebo group. Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
CONCLUSIONS


Supplementation with bovine lactoferrin did not decrease the incidence of sepsis in infants with birth weights of <2000 g. Growth and neurodevelopment outcomes at 24 months of age were similar. Neonatal bovine lactoferrin supplementation had no adverse effects.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01525316.",2020,"Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
","['414 infants enrolled', 'Infants Weighing Less', 'neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing']","['Bovine Lactoferrin', 'bovine lactoferrin', 'Neonatal bovine lactoferrin supplementation', 'placebo', 'bovine lactoferrin 200\xa0mg/kg/day with placebo']","['first episode of culture-proven LOS or sepsis-associated death', 'Sepsis\xa0and Neurodevelopment Impairment', 'mean age-adjusted normalized Mullen composite score', 'LOS or sepsis-associated death', 'prevention of late-onset sepsis (LOS) and neurodevelopment delay', 'Growth outcomes and rehospitalization rates', 'bronchiolitis', 'Neurodevelopment delay', 'incidence of sepsis']","[{'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C1440867', 'cui_str': 'lactoferrin, bovine'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",414.0,0.749494,"Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
","[{'ForeName': 'Theresa J', 'Initials': 'TJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Instituto de Medicina Tropical ""Alexander von Humboldt"", Universidad Peruana Cayetano Heredia, Lima, Peru; Center for Infectious Diseases, School of Public Health, University of Texas Health Science Center at Houston, Houston, TX. Electronic address: Theresa.Ochoa@upch.pe.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Zegarra', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Sicilia', 'Initials': 'S', 'LastName': 'Bellomo', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Cesar P', 'Initials': 'CP', 'LastName': 'Carcamo', 'Affiliation': 'School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cam', 'Affiliation': 'Department of Pediatrics, Hospital Nacional Alberto Sabogal, Lima, Peru.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Castañeda', 'Affiliation': 'Department of Pediatrics, Hospital Nacional Guillermo Almenara, Lima, Peru.'}, {'ForeName': 'Aasith', 'Initials': 'A', 'LastName': 'Villavicencio', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gonzales', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Rueda', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Christie G', 'Initials': 'CG', 'LastName': 'Turin', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Alonso', 'Initials': 'A', 'LastName': 'Zea-Vera', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Guillen', 'Affiliation': 'Department of Pediatrics, School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru; Department of Pediatrics, Hospital Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'Department of Mathematics, School of Science and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ewing-Cobbs', 'Affiliation': ""Department of Pediatrics and Children's Learning Institute, School of Medicine, University of Texas Health Science Center at Houston, Houston, TX.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.12.038']
444,31578564,Comparison of the removal of uraemic toxins with medium cut-off and high-flux dialysers: a randomized clinical trial.,"BACKGROUND


Accumulation of middle-weight uraemic toxins in haemodialysis (HD) patients results in increased morbidity and mortality. Whether medium cut-off HD (MCO-HD) improves removal of middle-weight uraemic toxins remains to be demonstrated.
METHODS


This cross-over prospective study included 40 patients randomly assigned to receive either 3 months of MCO-HD followed by 3 months of high-flux HD (HF-HD), or vice versa. The primary endpoint was myoglobin reduction ratio (RR) after 3 months of MCO-HD. Secondary endpoints were the effect of MCO-HD on other middle-weight toxins and protein-bound toxins, and on parameters of nutrition, inflammation, anaemia and oxidative stress.
RESULTS


Compared with HF-HD, MCO-HD provided higher mean RR of myoglobin (36 ± 8 versus 57 ± 13%, P < 0.0001), beta2-microglobulin (68 ± 6 versus 73 ± 15%, P = 0.04), prolactin (32 ± 13 versus 59 ± 11%, P < 0.0001), fibroblast growth factor 23 (20 ± 21 versus 41 ± 22%, P = 0.0002), homocysteine (43 ± 7 versus 46 ± 9%, P = 0.03) and higher median RR of kappa [54 (48-58) versus 70 (63-74)%, P < 0.0001] and lambda free light chain (FLC) [15 (9-22) versus 44 (38-49)%, P < 0.0001]. Mean ± SD pre-dialysis levels of beta2-microglobulin (28.4 ± 5.6 versus 26.9 ± 5.1 mg/L, P = 0.01) and oxidized low-density lipoprote (6.9 ± 4.4 versus 5.5 ± 2.5 pg/mL, P = 0.04), and median (interquartile range) kappa FLC [145 (104-203) versus 129 (109-190) mg/L, P < 0.03] and lambda FLC [106 (77-132) versus 89 (62-125) mg/L, P = 0.002] were significantly lower. Mean albumin levels decreased significantly (38.2 ± 4.1 versus 36.9 ± 4.3 g/L, P = 0.004), without an effect on nutritional status as suggested by unchanged normalized protein catabolic rate and transthyretin level.
CONCLUSIONS


Compared with HF-HD, MCO-HD provides higher myoglobin and other middle molecules RR and is associated with moderate hypoalbuminemia. The potential benefits of this strategy on long-term clinical outcomes deserve further evaluation.",2020,"FLC [145 (104-203) versus 129 (109-190) mg/L, P < 0.03] and lambda FLC [106 (77-132) versus 89 (62-125) mg/L, P = 0.002] were significantly lower.","['haemodialysis (HD) patients', '40 patients']","['medium cut-off HD (MCO-HD', 'uraemic toxins with medium cut-off and high-flux dialysers', 'HF-HD, MCO-HD', 'MCO-HD followed by 3\u2009months of high-flux HD (HF-HD), or vice versa']","['Mean\u2009±\u2009SD pre-dialysis levels of beta2-microglobulin', 'fibroblast growth factor', 'beta2-microglobulin', 'oxidized low-density lipoprote', 'lambda FLC', 'mean RR of myoglobin', 'myoglobin reduction ratio (RR', 'lambda free light chain (FLC', 'Mean albumin levels', 'effect of MCO-HD on other middle-weight toxins and protein-bound toxins, and on parameters of nutrition, inflammation, anaemia and oxidative stress', 'morbidity and mortality', 'median RR of kappa', 'FLC', 'prolactin', 'normalized protein catabolic rate and transthyretin level', 'homocysteine']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}, {'cui': 'C0605527', 'cui_str': 'MCO'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1720314', 'cui_str': 'Greek letter lambda'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0605527', 'cui_str': 'MCO'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C0522527', 'cui_str': 'Protein bound (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}]",40.0,0.0976827,"FLC [145 (104-203) versus 129 (109-190) mg/L, P < 0.03] and lambda FLC [106 (77-132) versus 89 (62-125) mg/L, P = 0.002] were significantly lower.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Belmouaz', 'Affiliation': 'Department of Nephrology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bauwens', 'Affiliation': 'Department of Nephrology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Hauet', 'Affiliation': 'Department of Biochemistry, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Bossard', 'Affiliation': 'Department of Biochemistry, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Jamet', 'Affiliation': 'Department of Nephrology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Department of Nephrology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Chikhi', 'Affiliation': 'Department of Nephrology, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Joffrion', 'Affiliation': 'Department of Biochemistry, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gand', 'Affiliation': ""Department of Biostatistics, Centre d'Investigation Clinique CIC 1402, Poitiers University Hospital, Poitiers, France.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bridoux', 'Affiliation': 'Department of Nephrology, Poitiers University Hospital, Poitiers, France.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz189']
445,32186653,Rationale and Design of the Aspirin Dosing-A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE) Trial.,"Importance


Determining the right dosage of aspirin for the secondary prevention treatment of atherosclerotic cardiovascular disease (ASCVD) remains an unanswered and critical question.
Objective


To report the rationale and design for a randomized clinical trial to determine the optimal dosage of aspirin to be used for secondary prevention of ASCVD, using an innovative research method.
Design, Setting, and Participants


This pragmatic, open-label, patient-centered, randomized clinical trial is being conducted in 15 000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States. Patients with established ASCVD treated in routine clinical practice within the network are eligible. Patient recruitment began in April 2016. Enrollment was completed in June 2019. Final follow-up is expected to be completed by June 2020.
Interventions


Participants are randomized on a web platform in a 1:1 fashion to either 81 mg or 325 mg of aspirin daily.
Main Outcomes and Measures


The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke. The primary safety end point is hospitalization for major bleeding associated with a blood-product transfusion. End points are captured through regular queries of the health systems' common data model within the structure of PCORnet's distributed data environment.
Conclusions and Relevance


As a pragmatic study and the first interventional trial conducted within the PCORnet electronic data infrastructure, this trial is testing several unique and innovative operational approaches that have the potential to disrupt and transform the conduct of future patient-centered randomized clinical trials by evaluating treatments integrated in clinical practice while at the same time determining the optimal dosage of aspirin for secondary prevention of ASCVD.
Trial Registration


ClinicalTrials.gov Identifier: NCT02697916.",2020,"The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke.","['15\u202f000 patients within the National Patient-Centered Clinical Research Network (PCORnet), a distributed research network of partners including clinical research networks, health plan research networks, and patient-powered research networks across the United States', 'atherosclerotic cardiovascular disease (ASCVD', 'Patients with established ASCVD treated in routine clinical practice within the network are eligible']","['aspirin', 'aspirin daily', 'Aspirin']","['hospitalization for major bleeding associated with a blood-product transfusion', 'composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",15000.0,0.141572,"The primary efficacy end point is the composite of all-cause mortality, hospitalization for nonfatal myocardial infarction, or hospitalization for a nonfatal stroke.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Marquis-Gravel', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Robertson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Berdan', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Madelaine', 'Initials': 'M', 'LastName': 'Faulkner', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, Los Angeles.'}, {'ForeName': 'Brahmajee K', 'Initials': 'BK', 'LastName': 'Nallamothu', 'Affiliation': 'Michigan Integrated Center of Health Analytics and Medical Prediction, Division of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Fintel', 'Affiliation': 'Feinberg School of Medicine, Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Ford', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Daugherty', 'Affiliation': 'Patient-Centered Outcomes Research Institute, Washington, DC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Nauman', 'Affiliation': 'Louisiana Public Health Institute, New Orleans.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kraschnewski', 'Affiliation': 'Department of Medicine, Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Faraz S', 'Initials': 'FS', 'LastName': 'Ahmad', 'Affiliation': 'Center for Health Information Partnerships, Feinberg School of Medicine, Institute of Public Health and Medicine, Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Catherine P', 'Initials': 'CP', 'LastName': 'Benziger', 'Affiliation': 'Essentia Health Heart and Vascular Center, Duluth, Minnesota.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore Inc, Wilmington, Delaware.'}, {'ForeName': 'J Greg', 'Initials': 'JG', 'LastName': 'Merritt', 'Affiliation': 'Patient-Centered Network of Learning Health Systems (LHSNet), Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Metkus', 'Affiliation': 'Division of Cardiology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Gupta', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Raj C', 'Initials': 'RC', 'LastName': 'Shah', 'Affiliation': ""Rush Alzheimer's Disease Center, Department of Family Medicine, Rush University Medical Center, Chicago, Illinois.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'McClay', 'Affiliation': 'Department of Emergency Medicine, University of Nebraska Medical Center College of Medicine, Omaha.'}, {'ForeName': 'Richard N', 'Initials': 'RN', 'LastName': 'Re', 'Affiliation': 'Ochsner Health System, New Orleans, Louisiana.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Geary', 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Lampert', 'Affiliation': 'Wexner Medical Center, Division of Cardiovascular Medicine, The Ohio State University, Columbus.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Bradley', 'Affiliation': 'Minneapolis Heart Institute, Minneapolis Heart Institute Foundation, Minneapolis.'}, {'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Jain', 'Affiliation': 'UPMC Heart and Vascular Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Seifein', 'Affiliation': 'AdventHealth Medical Group Cardiology, Oviedo, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Véronique L', 'Initials': 'VL', 'LastName': 'Roger', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Effron', 'Affiliation': 'Ochsner Clinical School, John Ochsner Heart and Vascular Institute, University of Queensland School of Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Alvarado', 'Affiliation': 'Herbert H. Lehman College, Department of Biological Sciences, City University of New York, Bronx.'}, {'ForeName': 'Ythan H', 'Initials': 'YH', 'LastName': 'Goldberg', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'VanWormer', 'Affiliation': 'Marshfield Clinic Research Institute, Marshfield, Wisconsin.'}, {'ForeName': 'Saket', 'Initials': 'S', 'LastName': 'Girotra', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Farrehi', 'Affiliation': 'University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rothman', 'Affiliation': 'Center for Health Services Research, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0116']
446,32186683,Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair: The RIVAL Randomized Clinical Trial.,"Importance


Despite rapid adoption of the robotic platform for inguinal hernia repair in the US, to date, no level I trials have ever compared robotic inguinal hernia repair to laparoscopic repair. This multicenter randomized clinical trial is the first to compare the robotic platform to laparoscopic approach for minimally invasive inguinal hernia repair.
Objective


To determine whether the robotic approach to inguinal hernia repair results in improved postoperative outcomes compared with traditional laparoscopic inguinal hernia repairs.
Design, Setting, and Participants


This multicenter, single-blinded, prospective randomized clinical pilot study was conducted from April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites. Enrolled in this study were 113 patients with a unilateral primary or recurrent inguinal hernia. After exclusions 102 remained for analysis.
Interventions


Standard laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair.
Main Outcomes and Measures


Main outcomes included postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis. Secondary outcomes included cost, surgeon ergonomics, and surgeon mental workload. A primary outcome was not selected because this study was designed as a pilot study. The hypothesis was formulated prior to data collection.
Results


A total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male; 48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male). There were no differences at the preoperative, 1-week, or 30-day points between the groups in terms of wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey. Compared with traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair was associated with longer median (interquartile range) operative times (75.5 [59.0-93.8] minutes vs 40.5 [29.2-63.8] minutes, respectively; P < .001), higher median (interquartile range) cost ($3258 [$2568-$4118] vs $1421 [$1196-$1930], respectively; P < .001), and higher mean (SD) frustration levels on the NASA Task Load Index Scale (range, 1-100, with lower scores indicating lower cognitive workload) (32.7 [23.5] vs 20.1 [19.2], respectively; P = .004). There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument.
Conclusions and Relevance


Results of this study showed no clinical benefit to the robotic approach to straightforward inguinal hernia repair compared with the laparoscopic approach. The robotic approach incurred higher costs and more operative time compared with the laparoscopic approach, with added surgeon frustration and no ergonomic benefit to surgeons.
Trial Registration


ClinicalTrials.gov Identifier: NCT02816658.",2020,"There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument.
","['48 in the robotic group, mean [SD] age, 56.1 [14.1] years and 44 [91.6%] male', '113 patients with a unilateral primary or recurrent inguinal hernia', 'A total of 102 patients were included in the study (54 in the laparoscopic group, mean [SD] age, 57.2 [13.3] years and 48 [88.9%] male', 'April 2016 to April 2019, with a follow-up duration of 30 days in 6 academic and academic-affiliated sites']","['traditional laparoscopic inguinal hernia repair, robotic transabdominal preperitoneal repair', 'laparoscopic approach', 'traditional laparoscopic inguinal hernia repairs', 'robotic approach to inguinal hernia repair', 'robotic inguinal hernia repair to laparoscopic repair', 'laparoscopic transabdominal preperitoneal repair or robotic transabdominal preperitoneal repair', 'Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair']","['wound events, readmissions, pain as measured by the Visual Analog Scale, or quality of life as measured by the 36-Item Short Form Health Survey', 'postoperative outcomes', 'NASA Task Load Index Scale', 'cognitive workload', 'postoperative pain, health-related quality of life, mobility, wound morbidity, and cosmesis', 'higher costs and more operative time', 'cost, surgeon ergonomics, and surgeon mental workload']","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0281962', 'cui_str': 'Recurrent inguinal hernia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0018246', 'cui_str': 'Groin'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242776', 'cui_str': 'NASA'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0086246', 'cui_str': 'Ergonomics'}]",113.0,0.348424,"There were no differences in ergonomics of the surgeons between the groups as measured by the Rapid Upper Limb Assessment instrument.
","[{'ForeName': 'Ajita S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Carbonell', 'Affiliation': 'Comprehensive Hernia Center, Department of Surgery, University of South Carolina School of Medicine Greenville, Greenville.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hope', 'Affiliation': 'Department of Surgery, New Hanover Regional Medical Center, University of North Carolina Wilmington, Wilmington.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Warren', 'Affiliation': 'Comprehensive Hernia Center, Department of Surgery, University of South Carolina School of Medicine Greenville, Greenville.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Higgins', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Jacob', 'Affiliation': 'Department of Surgery, Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Blatnik', 'Affiliation': 'Department of Surgery, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Haskins', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Hemasat', 'Initials': 'H', 'LastName': 'Alkhatib', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Tastaldi', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Fafaj', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Digestive Diseases and Surgery Institute, Cleveland Clinic, The Cleveland Clinic Foundation, Cleveland, Ohio.'}]",JAMA surgery,['10.1001/jamasurg.2020.0034']
447,32150229,Effectiveness of the Extension for Community Health Outcomes Model as Applied to Primary Care for Autism: A Partial Stepped-Wedge Randomized Clinical Trial.,"Importance


The Extension for Community Health Outcomes (ECHO) model is a widely adopted technology-based model for training primary care physicians and practitioners (PCPs) to care for patients with complex conditions. Despite its popularity, to our knowledge, direct effects of ECHO on clinical practice have not been tested in a large-scale study.
Objective


To test the effectiveness of the ECHO model as applied to primary care for autism and whether it resulted in improved clinical practice, knowledge, and self-efficacy regarding autism screening and comorbidity management.
Design, Setting, and Participants


Primary care physicians and practitioners were recruited to participate in a 6-month ECHO Autism program delivered by 1 of 10 academic medical center sites. A sequential, staggered rollout of ECHO Autism was delivered to 5 cohorts of participants (15 per site; 2 sites per cohort). Sites were randomized after recruitment to cohort/start time. Cohorts launched every 3 months. The ECHO Autism program used videoconferencing technology to connect community-based PCPs with interdisciplinary expert teams at academic medical centers. There were 148 participants (PCPs [family practice physicians, pediatricians, nurse practitioners, and physician assistants] providing outpatient services to underserved children) studied between December 2016 and November 2018.
Interventions


The 6-month ECHO Autism program included twelve 2-hour sessions connecting PCP participants with an interdisciplinary expert team. Sessions included didactics, case-based learning, guided practice, and discussion.
Main Outcomes and Measures


Coprimary outcomes were autism screening practices and comorbidity management (assessed by medical record review). Secondary outcomes were knowledge (assessed by direct testing) and self-efficacy (assessed by self-report survey). Assessments were conducted at baseline, mid-ECHO, post-ECHO, and follow-up (3 months after ECHO).
Results


Ten sites were randomized to 1 of 5 cohorts. Participants were 82% female (n = 108), 76% white (n = 100), and 6% Hispanic or Latino (n = 8); the median age was 46 years (interquartile range, 37-55 years). Significant changes in autism screening and treatment of comorbidities in children with autism were not observed. Participants demonstrated significant improvements in knowledge (9%; 95% CI, 4-13; P < .001) and self-efficacy (29%; 95% CI, 25-32; P < .001).
Conclusions and Relevance


The ECHO model was developed to increase access to high-quality health care for underserved patients with complex conditions. Study results provide support for the model in improving clinician knowledge and confidence but little support for achieving practice change.
Trial Registration


ClinicalTrials.gov Identifier: NCT03677089.",2020,"Participants demonstrated significant improvements in knowledge (9%; 95% CI, 4-13; P < .001) and self-efficacy (29%; 95% CI, 25-32; P < .001).
","['Primary Care for Autism', 'underserved patients with complex conditions', 'patients with complex conditions', 'children with autism', 'Participants\n\n\nPrimary care physicians and practitioners were recruited to participate in a 6-month ECHO Autism program delivered by 1 of 10 academic medical center sites', 'Participants were 82% female (n\u2009=\u2009108), 76% white (n\u2009=\u2009100), and 6% Hispanic or Latino (n\u2009=\u20098); the median age was 46 years (interquartile range, 37-55 years', '148 participants (PCPs [family practice physicians, pediatricians, nurse practitioners, and physician assistants] providing outpatient services to underserved children) studied between December 2016 and November 2018', 'ECHO Autism program included twelve 2-hour sessions connecting PCP participants with an interdisciplinary expert team']",[],"['didactics, case-based learning, guided practice, and discussion', 'self-efficacy', 'autism screening and treatment of comorbidities', 'knowledge', 'knowledge (assessed by direct testing) and self-efficacy (assessed by self-report survey', 'autism screening practices and comorbidity management (assessed by medical record review']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0237433', 'cui_str': 'Pediatricians'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0086751', 'cui_str': 'Outpatient Services'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}]",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0730229', 'cui_str': 'Medical records review (procedure)'}]",,0.0305996,"Participants demonstrated significant improvements in knowledge (9%; 95% CI, 4-13; P < .001) and self-efficacy (29%; 95% CI, 25-32; P < .001).
","[{'ForeName': 'Micah O', 'Initials': 'MO', 'LastName': 'Mazurek', 'Affiliation': 'Curry School of Education and Human Development, Department of Human Services, University of Virginia, Charlottesville.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Biostatistics Center, Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Biostatistics Center, Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kuhlthau', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Sohl', 'Affiliation': 'Department of Child Health, University of Missouri, Columbia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.6306']
448,31263057,Body Composition and Aspirin Dose for Colorectal Adenoma Prevention in a Randomized Clinical Trial.,"BACKGROUND


Visceral adiposity is a risk factor for colorectal adenomas, and aspirin is an established chemopreventive agent. Evidence from clinical trials suggests the effectiveness of aspirin at preventing cardiovascular disease and cancer may require higher doses for higher body weight.
METHODS


Body mass index, body surface area, fat-free mass, and fat mass were calculated from baseline height and weight in 1,121 participants of the Aspirin/Folate Polyp Prevention Study, a double-blind, placebo-controlled, 3 × 2 factorial randomized clinical trial of low-dose (81 mg/day) or high-dose (325 mg/day) aspirin and/or 1 mg/day folic acid to prevent metachronous colorectal adenomas. Participants were treated during a surveillance colonoscopy interval of approximately 3 years. Risk ratios (RR) with 95% confidence intervals (CI) for any colorectal neoplasia and high-risk adenoma (HRA, advanced or ≥3 adenomas) were estimated from log-linear regression.
RESULTS


We did not find evidence to suggest aspirin dose-response differed by body composition measurements, including weight alone. Among those weighing ≥ 80 kg, treatment effects for low-dose aspirin (RR for colorectal neoplasia, 0.75; 95% CI, 0.60-0.94; RR for HRA, 0.52; 95% CI, 0.31-0.86) and high-dose aspirin (RR for colorectal neoplasia, 0.88; 95% CI, 0.72-1.08; RR for HRA, 0.68; 95% CI, 0.43-1.09) were not meaningfully different than for those weighing 70-79 kg or <70 kg.
CONCLUSIONS


Measurements of body composition calculated from height and weight did not modify aspirin treatment effects for colorectal adenoma prevention.
IMPACT


Aspirin dosing strategies accounting for body weight suggested in previous trials of colorectal cancer may not apply to adenomas.",2019,"Among those weighing ≥ 80 kg, treatment effects for low-dose aspirin (RR for colorectal neoplasia, 0.75; 95% CI, 0.60-0.94; RR for HRA, 0.52; 95% CI, 0.31-0.86) and high-dose aspirin (RR for colorectal neoplasia, 0.88; 95% CI, 0.72-1.08; RR for HRA, 0.68; 95% CI, 0.43-1.09) were not meaningfully different than for those weighing 70-79 kg or <70 kg.
","['1,121 participants of the Aspirin/Folate Polyp Prevention Study, a double-blind']","['folic acid', 'Aspirin', 'aspirin', 'placebo']","['Risk ratios (RR', 'colorectal neoplasia and high-risk adenoma (HRA, advanced or ≥3 adenomas']","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]",,0.428762,"Among those weighing ≥ 80 kg, treatment effects for low-dose aspirin (RR for colorectal neoplasia, 0.75; 95% CI, 0.60-0.94; RR for HRA, 0.52; 95% CI, 0.31-0.86) and high-dose aspirin (RR for colorectal neoplasia, 0.88; 95% CI, 0.72-1.08; RR for HRA, 0.68; 95% CI, 0.43-1.09) were not meaningfully different than for those weighing 70-79 kg or <70 kg.
","[{'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. michael.n.passarelli@dartmouth.edu.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Ahnen', 'Affiliation': 'Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0205']
449,32212342,Nucleus Hybrid S12: Multicenter Clinical Trial Results.,"OBJECTIVES/HYPOTHESIS


The use of a short 10-mm/10-electrode cochlear implant to preserve low-frequency residual hearing was investigated. This report describes the 12-month outcomes of this multicenter clinical trial.
STUDY DESIGN


Single-subject design.
METHODS


Twenty-eight subjects with low-frequency hearing at or better than 60 dB HL at 500 Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear. Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences was collected pre- and postoperatively at 3, 6, and 12 months. Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire was also collected pre- and postoperatively.
RESULTS


Functional hearing preservation was accomplished in 96% of subjects. At 3 and 6 months, 86% of the 28 subjects had maintained functional hearing. By 12 months, 23 out of 27 subjects (85%) had maintained functional hearing (one subject with functional hearing at 6 months withdrew from the study prior to the 12-month visit). Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids. Furthermore, preoperative to 12 months postoperative subjective ratings showed significant improvements for the SSQ.
CONCLUSIONS


This study demonstrates that a high degree of hearing preservation enabling acoustic-electric hearing and improvement in speech understanding in quiet and in noise can be accomplished using a short-electrode 10-mm cochlear implant.
LEVEL OF EVIDENCE


2c Laryngoscope, 130:E548-E558, 2020.",2020,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"['Nucleus Hybrid S12', 'Twenty-eight subjects with low-frequency hearing at or better than 60\u2009dB HL at 500\u2009Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear']",['hearing preservation enabling acoustic-electric hearing'],"['Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire', 'Functional hearing preservation', 'Speech perception', 'Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences', 'maintained functional hearing', 'everyday listening condition']","[{'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018780', 'cui_str': 'Hearing Loss, High-Frequency'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",28.0,0.0168716,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"[{'ForeName': 'Camille C', 'Initials': 'CC', 'LastName': 'Dunn', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Cochlear Americas, Centennial, Colorado, U.S.A.'}, {'ForeName': 'Marlan R', 'Initials': 'MR', 'LastName': 'Hansen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Gantz', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}]",The Laryngoscope,['10.1002/lary.28628']
450,30890197,Neuropsychological Function Response to Nocturnal Blue Light Blockage in Individuals With Symptoms of Insomnia: A Pilot Randomized Controlled Study.,"OBJECTIVES


Insomnia is associated with neuropsychological dysfunction. Evidence points to the role of nocturnal light exposure in disrupted sleep patterns, particularly blue light emitted through smartphones and computers used before bedtime. This study aimed to test whether blocking nocturnal blue light improves neuropsychological function in individuals with insomnia symptoms.
METHODS


This study used a randomized, placebo-controlled crossover design. Participants were randomly assigned to a 1-week intervention with amber lenses worn in wrap-around frames (to block blue light) or a 1-week intervention with clear lenses (control) and switched conditions after a 4-week washout period. Neuropsychological function was evaluated with tests from the NIH Toolbox Cognition Battery at three time points: (1) baseline (BL), (2) following the amber lenses intervention, and (3) following the clear lenses intervention. Within-subjects general linear models contrasted neuropsychological test performance following the amber lenses and clear lenses conditions with BL performance.
RESULTS


Fourteen participants (mean(standard deviation, SD): age = 46.5(11.4)) with symptoms of insomnia completed the protocol. Compared with BL, individuals performed better on the List Sorting Working Memory task after the amber lenses intervention, but similarly after the clear lenses intervention (F = 5.16; p = .014; η2 = 0.301). A similar pattern emerged on the Pattern Comparison Processing Speed test (F = 7.65; p = 0.002; η2 = 0.370). Consideration of intellectual ability indicated that treatment with amber lenses ""normalized"" performance on each test from approximately 1 SD below expected performance to expected performance.
CONCLUSIONS


Using a randomized, placebo-controlled crossover design, we demonstrated improvement in processing speed and working memory with a nocturnal blue light blocking intervention among individuals with insomnia symptoms. (JINS, 2019, 25, 668-677).",2019,"Compared with BL, individuals performed better on the List Sorting Working Memory task after the amber lenses intervention, but similarly after the clear lenses intervention (F=5.16; p=.014; η2=0.301).","['Fourteen participants (mean(standard deviation, SD): age=46.5(11.4)) with symptoms of insomnia completed the protocol', 'individuals with insomnia symptoms', 'Individuals With Symptoms of Insomnia']","['placebo', 'nocturnal blue light blocking intervention', 'Neuropsychological Function Response to Nocturnal Blue Light Blockage', 'intervention with amber lenses worn in wrap-around frames (to block blue light) or a 1-week intervention with clear lenses (control', 'blocking nocturnal blue light']","['Neuropsychological function', 'processing speed and working memory', 'neuropsychological function']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0303896', 'cui_str': 'Blue light (physical force)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242864', 'cui_str': 'Amber'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.0516764,"Compared with BL, individuals performed better on the List Sorting Working Memory task after the amber lenses intervention, but similarly after the clear lenses intervention (F=5.16; p=.014; η2=0.301).","[{'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Zimmerman', 'Affiliation': 'Fordham University, Department of Psychology, Bronx, New York.'}, {'ForeName': 'Moosun Brad', 'Initials': 'MB', 'LastName': 'Kim', 'Affiliation': 'Institute of Human Nutrition, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Hale', 'Affiliation': ""Taub Institute for Research on Alzheimer's disease and the Aging Brain, Columbia University College of Physicians and Surgeons, New York, New York.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Westwood', 'Affiliation': 'Department of Neurology, Columbia University College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brickman', 'Affiliation': ""Taub Institute for Research on Alzheimer's disease and the Aging Brain, Columbia University College of Physicians and Surgeons, New York, New York.""}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000055']
451,31910279,Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment: A Randomized Clinical Trial.,"Importance


Dietary supplements marketed for male fertility commonly contain folic acid and zinc based on limited prior evidence for improving semen quality. However, no large-scale trial has examined the efficacy of this therapy for improving semen quality or live birth.
Objective


To determine the effect of daily folic acid and zinc supplementation on semen quality and live birth.
Design, Setting, and Participants


The Folic Acid and Zinc Supplementation Trial was a multicenter randomized clinical trial. Couples (n = 2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017. The last 6-month study visit for semen collection occurred during August 2018, with chart abstraction of live birth and pregnancy information completed during April 2019.
Interventions


Men were block randomized by study center and planned infertility treatment (in vitro fertilization, other treatment at a study site, and other treatment at an outside clinic) to receive either 5 mg of folic acid and 30 mg of elemental zinc (n = 1185) or placebo (n = 1185) daily for 6 months.
Main Outcomes and Measures


The co-primary outcomes were live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count) at 6 months after randomization.
Results


Among 2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit. Live birth outcomes were available for all couples, and 1629 men (69%) had semen available for analysis at 6 months after randomization. Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]). Most of the semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count) were not significantly different between treatment groups at 6 months after randomization. A statistically significant increase in DNA fragmentation was observed with folic acid and zinc supplementation (mean of 29.7% for percentage of DNA fragmentation in the folic acid and zinc group and 27.2% in the placebo group; mean difference, 2.4% [95% CI, 0.5% to 4.4%]). Gastrointestinal symptoms were more common with folic acid and zinc supplementation compared with placebo (abdominal discomfort or pain: 66 [6%] vs 40 [3%], respectively; nausea: 50 [4%] vs 24 [2%]; and vomiting: 32 [3%] vs 17 [1%]).
Conclusions and Relevance


Among a general population of couples seeking infertility treatment, the use of folic acid and zinc supplementation by male partners, compared with placebo, did not significantly improve semen quality or couples' live birth rates. These findings do not support the use of folic acid and zinc supplementation by male partners in the treatment of infertility.
Trial Registration


ClinicalTrials.gov Identifier: NCT01857310.",2020,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","['Couples (n\u2009', 'Couples Undergoing Infertility Treatment', '2370 men who were randomized (mean age, 33 years), 1773 (75%) attended the final 6-month study visit', '2370; men aged ≥18 years and women aged 18-45 years) planning infertility treatment were enrolled at 4 US reproductive endocrinology and infertility care study centers between June 2013 and December 2017']","['planned infertility treatment (in vitro fertilization', 'placebo', 'folic acid and zinc', 'daily folic acid and zinc supplementation', 'folic acid and zinc supplementation', 'folic acid and 30 mg of elemental zinc (n\u2009=\u20091185) or placebo', 'Folic Acid and Zinc Supplementation']","['Live birth', 'Live birth outcomes', 'vomiting', 'semen quality and live birth', 'DNA fragmentation', 'nausea', 'Gastrointestinal symptoms', 'live birth (resulting from pregnancies occurring within 9 months of randomization) and semen quality parameters (sperm concentration, motility, morphology, volume, DNA fragmentation, and total motile sperm count', 'Semen Quality and Live Birth', 'semen quality or live birth', 'semen quality parameters (sperm concentration, motility, morphology, volume, and total motile sperm count', ""semen quality or couples' live birth rates""]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1171199', 'cui_str': 'Family planning: infertility'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0200070', 'cui_str': 'Infertility therapy (procedure)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2717747', 'cui_str': 'Semen Quality'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1261167', 'cui_str': 'Sperm concentration'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4301985', 'cui_str': 'Motile spermatozoa'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]",2370.0,0.613709,"Live birth was not significantly different between treatment groups (404 [34%] in the folic acid and zinc group and 416 [35%] in the placebo group; risk difference, -0.9% [95% CI, -4.7% to 2.8%]).","[{'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Carrell', 'Affiliation': 'Departments of Surgery (Urology) and Human Genetics, School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Johnstone', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Chaney', 'Affiliation': 'Emmes Company LLC, Rockville, Maryland.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Van Voorhis', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Ginny', 'Initials': 'G', 'LastName': 'Ryan', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Obstetrics and Gynecology, Carver College of Medicine, University of Iowa, Iowa City.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hotaling', 'Affiliation': ""Center for Reconstructive Urology and Men's Health, Departments of Surgery (Urology) and Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Robins', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mills', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'C Matthew', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}]",JAMA,['10.1001/jama.2019.18714']
452,32401286,Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial.,"Importance


Health anxiety is a common and often chronic mental health problem associated with distress, substantial costs, and frequent attendance throughout the health care system. Face-to-face cognitive behavior therapy (CBT) is the criterion standard treatment, but access is limited.
Objective


To test the hypothesis that internet-delivered CBT, which requires relatively little resources, is noninferior to face-to-face CBT in the treatment of health anxiety.
Design, Setting, and Participants


This randomized noninferiority clinical trial with health economic analysis was based at a primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care. Recruitment began in December 10, 2014, and the last treatment ended on July 23, 2017. Follow-up data were collected up to 12 months after treatment. Analysis began October 2017 and ended March 2020.
Interventions


Patients were randomized (1:1) to 12 weeks of internet-delivered CBT or to individual face-to-face CBT.
Main Outcomes and Measures


Change in health anxiety symptoms from baseline to week 12. Analyses were conducted from intention-to-treat and per-protocol (completers only) perspectives, using the noninferiority margin of 2.25 points on the Health Anxiety Inventory, which has a theoretical range of 0 to 54.
Results


Overall, 204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period. Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50%) were randomized to face-to-face CBT. The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25). The between-group effect was not moderated by initial symptom level, recruitment path, or patient treatment preference. Therapists spent 10.0 minutes per patient per week in the online treatment vs 45.6 minutes for face-to-face CBT. The net societal cost was lower in the online treatment (treatment period point difference: $3854). There was no significant group difference in the number of adverse events, and no serious adverse event was reported.
Conclusions and Relevance


In this trial, internet-delivered CBT appeared to be noninferior to face-to-face CBT for health anxiety, while incurring lower net societal costs. The online treatment format has potential to increase access to evidence-based treatment for health anxiety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02314065.",2020,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"['Of 204 patients, 102 (50%) were randomized to internet-delivered CBT, and 102 (50', '204 patients (mean [SD] age, 39 [12] years; 143 women [70%]) contributed with 2386 data points on the Health Anxiety Inventory over the treatment period', 'primary care clinic and included patients with a principal diagnosis of health anxiety who were self-referred or referred from routine care', 'Health Anxiety']","['Face-to-face cognitive behavior therapy (CBT', 'internet-delivered CBT or to individual face-to-face CBT', 'Internet vs Face-to-Face Cognitive Behavior Therapy']","['initial symptom level, recruitment path, or patient treatment preference', 'health anxiety symptoms', 'net societal cost', '1-sided 95% CI upper limits', 'number of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C3266254', 'cui_str': 'Referred by self'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.102247,The 1-sided 95% CI upper limits for the internet-delivered CBT vs face-to-face CBT difference in change were within the noninferiority margin in the intention-to-treat analysis (B = 0.00; upper limit: 1.98; Cohen d = 0.00; upper limit: 0.23) and per-protocol analysis (B = 0.01; upper limit: 2.17; Cohen d = 0.00; upper limit: 0.25).,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Björkander', 'Affiliation': 'Gustavsberg Academic Primary Care Clinic, Gustavsberg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0940']
453,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND


Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition.
METHODS


In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment.
RESULTS


All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
CONCLUSIONS


Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up.
IMPACT


The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up. The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06).
","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8']
454,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z']
455,31759036,Comparison of liquid-based cytology with conventional smear cytology for EUS-guided FNA of solid pancreatic masses: a prospective randomized noninferiority study.,"BACKGROUND AND AIMS


There are limited data on the efficacy of liquid-based cytology (LBC) for EUS-guided FNA specimens. We aimed to evaluate the diagnostic efficacy of LBC for solid pancreatic neoplasms compared with conventional smears (CSs).
METHODS


In this randomized, crossover, noninferiority trial, we randomly assigned (1:1) patients with suspected pancreatic cancer to the LBC group or the CS group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. A noninferiority margin of -10% was assumed.
RESULTS


Of 170 randomized patients, 165 were classified as malignant and 5 as benign. Unsatisfactory samples were less frequent in the LBC group (1.78%) compared with the CS group (5.33%). The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of LBC versus CS were 88.0% versus 83.8% (P = .276), 87.7% versus 83.2% (P = .256), 100% versus 100% (P = .999), 100% versus 100% (P = .999), and 16.7% versus 16.1% (P = .953), respectively. A bloody background was significantly more frequent in the CS group (CS, 85.2%; LBC, 1.8%; P < .001), whereas the nuclear features were similar for both groups.
CONCLUSIONS


The diagnostic usefulness of LBC was comparable with that of CS. The cytomorphologic features did not differ significantly between the 2 methods, and the reduced bloody backgrounds allowed better visibility in the LBC method. (Clinical trial registration number: NCT03606148.).",2020,"The cytomorphologic features did not significantly differ between the 2 methods, and the reduced bloody backgrounds allowed better visibility in LBC method.","['170 randomized patients, 165 were classified as ""malignant"" and 5 as ""benign', 'patients with suspected pancreatic cancer to either LBC or CS groups']","['liquid-based cytology (LBC) for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA', 'liquid-based cytology with conventional smear cytology for EUS-guided fine-needle aspiration', 'LBC', 'conventional smears (CS']","['diagnostic utility of LBC', 'cytomorphologic features', 'diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of LBC versus CS', 'diagnostic efficacy']","[{'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C1880510', 'cui_str': 'EUS-FNA'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1510483', 'cui_str': 'Fine-Needle Aspiration'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",170.0,0.0712164,"The cytomorphologic features did not significantly differ between the 2 methods, and the reduced bloody backgrounds allowed better visibility in LBC method.","[{'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Chun', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyoungbun', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Department of Pathology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hyub', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Haeryoung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Pathology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Min Su', 'Initials': 'MS', 'LastName': 'You', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon Jung', 'Initials': 'YJ', 'LastName': 'Hwang', 'Affiliation': 'Department of Pathology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Hyun', 'Initials': 'WH', 'LastName': 'Paik', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Kon', 'Initials': 'JK', 'LastName': 'Ryu', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yong-Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.018']
456,32144883,Prefrontal Cortex Neuromodulation Enhances Frontal Asymmetry and Reduces Caloric Intake in Patients with Morbid Obesity.,"OBJECTIVE


The objective of this study was to test the feasibility of a combined intervention involving transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex (dlPFC) and cognitive training (CT). Short-term effects on food consumption, cognition, endocannabinoid (eCB) levels, and electroencephalogram (EEG) markers of future weight loss were explored.
METHODS


Eighteen healthy volunteers with morbid obesity were randomized in a double-blind, placebo-controlled, parallel trial. Participants received sham or active tDCS plus CT for four consecutive days. Cognitive performance, daily food intake, and eCB blood samples were collected before and after the intervention; EEG data were gathered before and after daily training.
RESULTS


The active tDCS + CT group reversed left-dominant frontal asymmetry and increased frontal coherence (FC) in the γ-band (30-45 Hz) after the intervention. The strength of the latter predicted BMI reduction. Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations.
CONCLUSIONS


dlPFC modulation through tDCS + CT is an effective tool to restore right dominance of the dlPFC and enhance FC in patients with morbid obesity. Moreover, the effect of the strength of FC on BMI suggests that the interhemispheric FC at the dlPFC is functionally relevant for the efficient regulation of food choice.",2020,"Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations.
","['patients with morbid obesity', 'Patients with Morbid Obesity', 'Eighteen healthy volunteers with morbid obesity']","['cognitive training (CT', 'combined intervention involving transcranial direct current stimulation (tDCS', 'tDCS\u2009+\u2009CT', 'sham or active tDCS plus CT', 'placebo', 'Prefrontal Cortex Neuromodulation Enhances Frontal Asymmetry']","['Cognitive performance, daily food intake, and eCB blood samples', 'food intake', 'food consumption, cognition, endocannabinoid (eCB) levels, and electroencephalogram (EEG)\xa0markers of future weight loss', 'plasma eCB concentrations', 'Caloric Intake', 'left-dominant frontal asymmetry and increased frontal coherence (FC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",18.0,0.0381687,"Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations.
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Forcano', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Castellano', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Cuenca-Royo', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday-Arno', 'Affiliation': 'Morbid Obesity Care Unit, IMIM-Hospital del Mar Medical Research Institute Barcelona, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Pastor', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Langohr', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}, {'ForeName': 'Karla Alejandra', 'Initials': 'KA', 'LastName': 'Pérez-Vega', 'Affiliation': 'Unit of Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Serra', 'Affiliation': 'Morbid Obesity Care Unit, IMIM-Hospital del Mar Medical Research Institute Barcelona, Barcelona, Spain.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruffini', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard University, Boston, Massachusetts, USA.'}, {'ForeName': 'Aureli', 'Initials': 'A', 'LastName': 'Soria-Frisch', 'Affiliation': 'Starlab Barcelona SL, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Torre', 'Affiliation': 'Neurosciences Research Program. Integrative Pharmacology and Systems Neuroscience Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22745']
457,31797417,"Effect of Aerobic or Resistance Exercise, or Both, on Bone Mineral Density and Bone Metabolism in Obese Older Adults While Dieting: A Randomized Controlled Trial.","Weight loss therapy of older adults with obesity is limited by weight loss-induced decrease in bone mineral density (BMD), which could exacerbate ongoing age-related bone loss and increase the risk for fractures. Therefore, it is recommended that weight loss therapy of older adults with obesity should include an intervention such as regular exercise to reduce the concomitant bone loss. However, the most appropriate exercise types to combine with weight loss therapy in this older population is unknown. In a randomized controlled trial, we performed a head-to-head comparison of aerobic or resistance exercise, or both, during matched ~10% weight loss in 160 older adults with obesity. We measured changes in BMD (total hip, femoral neck, trochanter, intertrochanter, one-third radius, lumbar spine) and bone markers. Changes between groups were analyzed using mixed-model repeated measures analyses of variance. After 6 months of intensive lifestyle interventions, BMD decreased less in the resistance group (-0.006 g/cm 2  [-0.7%]) and combination group (-0.012 g/cm 2  [-1.1%]) than in the aerobic group (-0.027 g/cm 2  [-2.6%]) (p = 0.001 for between-group comparisons). Serum C-telopeptide, procollagen type 1 N-propeptide, and osteocalcin concentrations increased more in the aerobic group (33%, 16%, and 16%, respectively) than in the resistance group (7%, 2%, and 0%, respectively) and combination group (11%, 2%, and 5%, respectively) (p = 0.004 to 0.048 for between-group comparisons). Multiple regression analyses revealed that the decline in whole body mass and serum leptin were the independent predictors of the decline in hip BMD (multiple R = 0.45 [p < .001]). These findings indicate that compared with aerobic exercise, resistance and combined aerobic and resistance exercise are associated with less weight loss-induced decrease in hip BMD and less weight loss-induced increase in bone turnover. Therefore, both resistance and combined aerobic and resistance exercise can be recommended to protect against bone loss during weight loss therapy of older adults with obesity. (LITOE ClinicalTrials.gov number NCT01065636.) © 2019 American Society for Bone and Mineral Research. Published 2019. This article is a U.S. Government work and is in the public domain in the USA.",2020,"osteocalcin concentrations increased more in the aerobic group (33%, 16%, and 16%, respectively) than in the resistance group (7%, 2%, and 0%, respectively) and combination group (11%, 2%, and 5%, respectively) (p = 0.004 to 0.048 for between-group comparisons).","['160 older adults with obesity', '© 2019 American Society for Bone and Mineral Research', 'Obese Older Adults', 'older adults with obesity']","['aerobic or resistance exercise', 'Aerobic or Resistance Exercise', 'Weight loss therapy', 'combined aerobic and resistance exercise']","['bone turnover', 'osteocalcin concentrations', 'Serum C-telopeptide, procollagen type 1\u2009N-propeptide, and', 'hip BMD', 'bone mineral density (BMD', 'whole body mass and serum leptin', 'weight loss', 'BMD (total hip, femoral neck, trochanter, intertrochanter, one-third radius, lumbar spine) and bone markers', 'Bone Mineral Density and Bone Metabolism']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",160.0,0.0498452,"osteocalcin concentrations increased more in the aerobic group (33%, 16%, and 16%, respectively) than in the resistance group (7%, 2%, and 0%, respectively) and combination group (11%, 2%, and 5%, respectively) (p = 0.004 to 0.048 for between-group comparisons).","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aguirre', 'Affiliation': 'Medicine Care Line, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Division of Bone and Mineral Diseases, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Department of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, TX, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3905']
458,32163097,Comparison of Carboplatin Plus Pemetrexed Followed by Maintenance Pemetrexed With Docetaxel Monotherapy in Elderly Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.,"Importance


Few clinical trials have been specifically designed for elderly patients with advanced non-small cell lung cancer (NSCLC), and the anticipated increase in the number of such patients has prompted a search for new treatment options that provide a greater palliative benefit.
Objective


To determine whether treatment with carboplatin plus pemetrexed followed by pemetrexed maintenance is noninferior compared with docetaxel monotherapy with regard to overall survival (OS) for elderly patients with advanced nonsquamous NSCLC.
Design, Setting, and Participants


This open-label, multicenter, noninferiority phase 3 randomized clinical trial was conducted at 79 institutions in Japan. Cytotoxic chemotherapy-naive patients with advanced nonsquamous NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, and age of 75 years or older were enrolled between August 2013 and February 2017. Data were analyzed from November 2018 to February 2019.
Interventions


Patients were randomized to receive either docetaxel monotherapy (60 mg/m2) every 3 weeks or 4 cycles of carboplatin (area under the curve of 5) plus pemetrexed (500 mg/m2) administered every 3 weeks followed by maintenance therapy with the same dose of pemetrexed for 3 weeks.
Main Outcomes and Measures


The primary end point was OS analyzed on an intention-to-treat basis with a noninferiority margin of 1.154 for the upper limit of the 95% CI of the hazard ratio (HR) estimated with a stratified Cox regression model.
Results


Of the 433 enrolled patients, 250 (57.7%) were male, and the median (range) age was 78 (75-88) years. The median OS was 15.5 months (95% CI, 13.6-18.4) in the docetaxel group (n = 217) and 18.7 months (95% CI, 16.0-21.9) in the carboplatin-pemetrexed group (n = 216), with a stratified HR for OS of 0.850 (95% CI, 0.684-1.056; P for noninferiority = .003). Progression-free survival was also longer in the carboplatin-pemetrexed group (unstratified HR, 0.739; 95% CI, 0.609-0.896). Compared with those in the docetaxel group, those in the carboplatin-pemetrexed had lower rates of leukopenia (60 of 214 [28.0%] vs 147 of 214 [68.7%]) and neutropenia (99 of 214 [46.3%] vs 184 of 214 [86.0%]) of grade 3 or 4 and of febrile neutropenia (9 of 214 [4.2%] vs 38 of 214 [17.8%]) and higher rates of thrombocytopenia (55 of 214 [25.7%] vs 3 of 214 [1.4%]) and anemia (63 of 214 [29.4%] vs 4 of 214 [1.9%]) of grade 3 or 4. Dose reductions were less frequent with carboplatin-pemetrexed.
Conclusion and Relevance


Carboplatin-pemetrexed treatment followed by pemetrexed maintenance is a valid option for first-line treatment of elderly patients with advanced nonsquamous NSCLC.
Trial Registration


University Hospital Medical Information Network Clinical Trials Registry Identifier: UMIN000011460.",2020,"Progression-free survival was also longer in the carboplatin-pemetrexed group (unstratified HR, 0.739; 95% CI, 0.609-0.896).","['Elderly Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer', 'naive patients with advanced nonsquamous NSCLC, an Eastern Cooperative Oncology Group performance status of 0 or 1, and age of 75 years or older were enrolled between August 2013 and February 2017', '433 enrolled patients, 250 (57.7%) were male, and the median (range) age was 78 (75-88) years', 'Data were analyzed from November 2018 to February 2019', '79 institutions in Japan', 'elderly patients with advanced non-small cell lung cancer (NSCLC', 'elderly patients with advanced nonsquamous NSCLC']","['carboplatin-pemetrexed', 'docetaxel monotherapy', 'Carboplatin Plus Pemetrexed', 'carboplatin (area under the curve of 5) plus pemetrexed', 'Docetaxel Monotherapy', 'docetaxel', 'carboplatin plus pemetrexed', 'Pemetrexed', 'Cytotoxic chemotherapy']","['rates of thrombocytopenia', 'median OS', 'rates of leukopenia', 'overall survival (OS', 'febrile neutropenia', 'neutropenia', 'Progression-free survival', 'anemia']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",433.0,0.153118,"Progression-free survival was also longer in the carboplatin-pemetrexed group (unstratified HR, 0.739; 95% CI, 0.609-0.896).","[{'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nokihara', 'Affiliation': 'Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'Japan Clinical Oncology Group (JCOG) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Niho', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Azuma', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Yoneshima', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Atagi', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Ozaki', 'Affiliation': 'Division of Medical Oncology, Kishiwada City Hospital, Osaka, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Horiike', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Kanagawa, Japan.""}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6828']
459,31864393,Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial.,"BACKGROUND


Diabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed that the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing microalbuminuria and macroalbuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD.
METHODS/DESIGN


This trial is a 13-center, randomized, double-blind, placebo-controlled study. A total of 632 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus losartan) and a control group (placebo plus losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in the urine microalbumin-creatinine ratio from baseline to week 24. The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups. Safety in medication will also be evaluated.
DISCUSSION


We hypothesize that patients with type 2 diabetes in the early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03009864. Registered January 2017.",2019,"The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups.","['patients with type 2 diabetes', 'type 2 diabetic kidney disease in the early stage', 'Diabetic kidney disease (DKD', 'patients with DKD', '632 participants']","['Chinese herbal Tangshen Formula (TSF', 'experiment group (TSF plus losartan', 'control group (placebo plus losartan', 'placebo', 'Chinese herbal medicine Tangshen Formula treatment', 'TSF']","['rate of progression to the clinical proteinuria period', 'rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate', 'microalbuminuria and macroalbuminuria and improving renal function', 'urine microalbumin-creatinine ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C4547931', 'cui_str': 'tangshen'}, {'cui': 'C0048723', 'cui_str': 'phenylmethane sulfonyl fluoride'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0564623', 'cui_str': 'Urine microalbumin negative (finding)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0740086', 'cui_str': 'Microalbuminuria measurement'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",632.0,0.660434,"The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups.","[{'ForeName': 'De', 'Initials': '', 'LastName': 'Jin', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Wen-Jing', 'Initials': 'WJ', 'LastName': 'Huang', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Bao', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Mei-Zhen', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China.""}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Yang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Ni', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China. niqing669@163.com.""}, {'ForeName': 'Feng-Mei', 'Initials': 'FM', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China. 694397644@qq.com.""}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, 100053, China. tongxiaolin66@sina.com.""}]",Trials,['10.1186/s13063-019-3821-6']
460,32208844,Impact of Treatment Delay on Outcome in the International Subarachnoid Aneurysm Trial.,"Background and Purpose- ISAT (International Subarachnoid Aneurysm Trial) demonstrated that 1 year after aneurysmal subarachnoid hemorrhage, coiling resulted in a significantly better clinical outcome than clipping. After 5 years, this difference did not reach statistical significance, but mortality was still higher in the clipping group. Here, we present additional analyses, reporting outcome after excluding pretreatment deaths. Methods- Outcome measures were death with or without dependency at 1 and 5 years after treatment, after exclusion of all pretreatment deaths. Treatment differences were assessed using relative risks (RRs). With sensitivity and exploratory analyses, the relation between treatment delay and outcome was analyzed. Results- After exclusion of pretreatment deaths, at 1-year follow-up coiling was favorable over clipping for death or dependency (RR, 0.77 [95% CI, 0.67-0.89]) but not for death alone (RR, 0.88 [95% CI, 0.66-1.19]). After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88 [95% CI, 0.77-1.02]) nor for death alone (RR, 0.82 [95% CI, 0.64-1.05]). Sensitivity analyses showed a similar picture. In good-grade patients, coiling remained favorable over clipping in the long-term. Time between randomization and treatment was significantly longer in the clipping arm (mean 1.7 versus 1.1 days;  P <0.0001), during which 17 patients died because of rebleeding versus 6 pretreatment deaths in the endovascular arm (RR, 2.81 [95% CI, 1.11-7.11]). Conclusions- These additional analyses support the conclusion of ISAT that at 1-year follow-up after aneurysmal subarachnoid hemorrhage coiling has a better outcome than clipping. After 5 years, with pretreatment mortality excluded, the difference between coiling and clipping is not significant. The high number of pretreatment deaths in the clipping group highlights the importance of urgent aneurysm treatment to prevent early rebleeding.",2020,"After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88",[],"['Conclusions', ' and Purpose- ISAT', 'Methods']","['mortality', 'relative risks (RRs', 'death or dependency', 'death with or without dependency']",[],"[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}]",,0.305041,"After 5 years, no significant differences were observed, neither for death or dependency (RR, 0.88","[{'ForeName': 'Carlina E', 'Initials': 'CE', 'LastName': 'van Donkelaar', 'Affiliation': 'From the Department of Neurosurgery (C.E.v.D., N.A.B., J.M.C.v.D.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Nicolaas A', 'Initials': 'NA', 'LastName': 'Bakker', 'Affiliation': 'From the Department of Neurosurgery (C.E.v.D., N.A.B., J.M.C.v.D.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Birks', 'Affiliation': 'Center for Statistics in Medicine, Oxford, United Kingdom (J.B.).'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford University Hospitals Foundation NHS Trust, United Kingdom (A.C., M.S., A.J.M.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sneade', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford University Hospitals Foundation NHS Trust, United Kingdom (A.C., M.S., A.J.M.).'}, {'ForeName': 'Richard S C', 'Initials': 'RSC', 'LastName': 'Kerr', 'Affiliation': 'Department of Neurosurgery, John Radcliffe Hospital, Oxford, United Kingdom (R.S.C.K.).'}, {'ForeName': 'Nic J G M', 'Initials': 'NJGM', 'LastName': 'Veeger', 'Affiliation': 'Department of Epidemiology (N.J.G.M.V.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'From the Department of Neurosurgery (C.E.v.D., N.A.B., J.M.C.v.D.), University of Groningen, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Molyneux', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford University Hospitals Foundation NHS Trust, United Kingdom (A.C., M.S., A.J.M.).'}]",Stroke,['10.1161/STROKEAHA.120.028993']
461,32402480,Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial.,"BACKGROUND


Headache is a common complaint of emergency department (ED) patients and current treatment varies with significant limitations.
OBJECTIVE


Our aim was to evaluate the efficacy and safety of 2.5 mg i.v. haloperidol in the treatment of severe benign headache in the ED.
METHODS


A randomized, double-blind, placebo-controlled trial was performed in the ED of a single high-volume teaching hospital. Convenience sampling identified 287 eligible patients 13 to 55 years old with benign headache. One hundred and eighteen patients were enrolled to receive either 2.5 mg of haloperidol i.v. or placebo. The primary outcome measure was pain reduction at 60 min. Patients were evaluated for adverse events and follow-up was conducted after discharge. QT measurement was performed at baseline and discharge.
RESULTS


Fifty-eight patients received haloperidol and 60 patients received placebo. Patients in the haloperidol group reported an average 4.77-unit reduction in visual analogue scale score at 60 min compared to a 1.87-unit reduction in the control group. Thirty-four patients (58.6%) in the haloperidol group had complete resolution of their headache. Treatment with rescue ketorolac was required in 78.3% of the control group and 31% of the haloperidol group. Adverse events were uncommon, benign, and easily treated. No patients in the haloperidol group were found to have QT lengthening.
CONCLUSIONS


This study suggests that 2.5 mg i.v. haloperidol is a rapid and effective treatment for acute, severe, benign headache in ED patients aged 18 to 55 years. Further study is warranted to confirm these results in adolescents.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT02747511.",2020,"haloperidol is a rapid and effective treatment for acute, severe, benign headache in ED patients aged 18 to 55 years.","['One hundred and eighteen patients', 'ED of a single high-volume teaching hospital', '287 eligible patients 13 to 55\xa0years old with benign headache', 'ED patients aged 18 to 55\xa0years', 'adolescents']","['haloperidol i.v', 'ketorolac', 'haloperidol', 'placebo']","['pain reduction', 'QT measurement', 'severe benign headache', 'visual analogue scale score', 'efficacy and safety', 'adverse events', 'complete resolution of their headache', 'QT lengthening']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441592', 'cui_str': 'Surgical lengthening - action'}]",118.0,0.113547,"haloperidol is a rapid and effective treatment for acute, severe, benign headache in ED patients aged 18 to 55 years.","[{'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'McCoy', 'Affiliation': 'Department of Emergency Medicine, Western Michigan University, Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Aldy', 'Affiliation': 'Department of Emergency Medicine, Western Michigan University, Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Arnall', 'Affiliation': 'Department of Emergency Medicine, Western Michigan University, Homer Stryker M.D. School of Medicine, Kalamazoo, Michigan.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Petersen', 'Affiliation': 'Emergency Department, Bronson Methodist Hospital, Kalamazoo, Michigan.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.018']
462,31183588,Effectiveness of Workplace-Based Muscle Resistance Training Exercise Program in Preventing Musculoskeletal Dysfunction of the Upper Limbs in Manufacturing Workers.,"Aims Given the high levels of absenteeism due to musculoskeletal disorders of the upper limbs, there is a need for preventive strategies to protect workers exposed to high risk levels. The purpose of this study was to determine the effect of a workplace-based muscle resistance training exercise program in the presence of pain and musculoskeletal dysfunction of the upper extremities in manufacturing workers exposed to repetitive movements and excessive effort in the workplace. Method Randomized controlled trial in manufacturing workers. A sample of 120 healthy workers was allocated at random to an experimental group, which received a resistance-based exercise program, and a control group, which performed stretching exercises. Results The muscle resistance training exercise had a protective effect on the intensity of pain perceived by workers in their upper limbs (RR: 0.62 95% CI 0.44-0.87) compared with the group of workers who performed stretching exercises. Conclusion A workplace-based muscle resistance training exercise program is an effective preventive strategy in factory workers exposed to risk; however, it is necessary for companies initially to adopt mechanisms to minimize exposure as a prevention strategy.",2019,Results The muscle resistance training exercise had a protective effect on the intensity of pain perceived by workers in their upper limbs (RR: 0.62 95% CI 0.44-0.87) compared with the group of workers who performed stretching exercises.,"['pain and musculoskeletal dysfunction of the upper extremities in manufacturing workers', '120 healthy workers', 'manufacturing workers', 'Musculoskeletal Dysfunction of the Upper Limbs in Manufacturing Workers']","['resistance-based exercise program, and a control group, which performed stretching exercises', 'workplace-based muscle resistance training exercise program', 'Workplace-Based Muscle Resistance Training Exercise Program']",['intensity of pain'],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",120.0,0.0235499,Results The muscle resistance training exercise had a protective effect on the intensity of pain perceived by workers in their upper limbs (RR: 0.62 95% CI 0.44-0.87) compared with the group of workers who performed stretching exercises.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Muñoz-Poblete', 'Affiliation': 'Depto. Salud Pública, Universidad de La Frontera, Temuco, Chile. claudio.munoz@ufrontera.cl.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bascour-Sandoval', 'Affiliation': 'Depto. Medicina Interna, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Inostroza-Quiroz', 'Affiliation': 'Depto. Medicina Interna, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Solano-López', 'Affiliation': 'Depto. Especialidades Médicas, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Soto-Rodríguez', 'Affiliation': 'Depto. Medicina Interna, Universidad de La Frontera, Temuco, Chile.'}]",Journal of occupational rehabilitation,['10.1007/s10926-019-09840-7']
463,32171600,Effect of Preoperative Intramuscular Injection of Botulinum Toxin A on Pain and Mouth Opening After Surgical Intervention in Temporomandibular Joint Ankylosis Cases: A Controlled Clinical Trial.,"PURPOSE


The aim of the present study was to determine the effect of intramuscular injection of botulinum toxin A (BTX-A) into the masticatory muscles on the physiotherapy pain and mouth opening outcomes after surgical intervention of temporomandibular joint (TMJ) ankylosis and to verify the effects using electromyographic studies.
PATIENTS AND METHODS


The study included 20 patients with TMJ ankylosis. The patients were further subdivided into control and interventional groups. The interventional group was given intramuscular injections of BTX-A in the masticator muscles before surgery. Only saline injections were given to the control group. All 20 patients were evaluated for pain and ease of active physiotherapy at the 1-week and 1-, 3-, and 6-month follow-up visits using a questionnaire. Intergroup comparisons were performed for both groups. Electromyographic (EMG) studies were also performed in the intervention group for each patient. EMG recordings were performed of the individual masticator muscle in each patient before injection and at 1 and 3 months after injection.
RESULTS


The intervention group showed better results with respect to pain during the mouth opening exercises and improvements in mouth opening. All the interventional group patients showed a transient decrease in the microvolt value on the EMG studies of their masticator muscles on injection of BTX-A.
CONCLUSIONS


BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.",2020,BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.,"['20 patients with TMJ ankylosis', 'Temporomandibular Joint Ankylosis Cases']","['botulinum toxin A (BTX-A', 'Botulinum Toxin A']","['Pain and Mouth Opening', 'pain and ease of active physiotherapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]",20.0,0.0250176,BTX-A injection can be a straightforward and useful adjunct to surgical treatment of TMJ ankylosis for the reduction of pain during postoperative physiotherapy.,"[{'ForeName': 'Saatvik', 'Initials': 'S', 'LastName': 'Shandilya', 'Affiliation': 'Postgraduate Student, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India. Electronic address: drsujatam@hotmail.com.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Chaudhary', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Sanchaita', 'Initials': 'S', 'LastName': 'Kohli', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of Dental Sciences, New Delhi, India.'}, {'ForeName': 'Rudra Deo', 'Initials': 'RD', 'LastName': 'Kumar', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.011']
464,30502314,"Health, Physical Growth, and Neurodevelopmental Outcomes in Preterm Infants of Women With Hypertensive Disorders of Pregnancy.","OBJECTIVE


To compare the health, physical growth, and developmental outcomes in preterm infants of women with and without hypertensive disorders of pregnancy (HDP).
DESIGN


Cross-sectional analysis of health outcomes; physical growth (head circumference, height, and weight) collected at birth and 2 months, corrected for prematurity; and cognitive, language, and motor skills of preterm infants of women with and without HDP.
SETTING


Four NICUs in the United States.
PARTICIPANTS


Women (n = 221) and their preterm infants who weighed less than 1,750 g were enrolled in a multicenter, randomized trial of two interventions administered by each infant's mother when the infant was no longer critically ill.
METHODS


Women and their preterm infants were categorized into groups with (n = 80) and without (control, n = 141) HDP. Data were extracted from infants' medical records, and the women completed questionnaires.
RESULTS


The infants of women with HDP were more likely to be small for gestational age than the infants of women without HDP (31.7% vs. 10.6%, p < .002). The proportion of infants with greater neurologic risk, patent ductus arteriosus, intraventricular hemorrhage, and days on a ventilator did not differ between the groups. Although mean infant height at 2 months was less in the HDP group than the control group, other growth and neurodevelopmental outcomes did not differ between the groups.
CONCLUSION


Among preterm infants admitted to NICUs, those born to women with HDP were more likely to be small for gestational age than those born to normotensive women. Additional research is needed to optimize care for infants born to women with HDP.",2019,"The infants of women with HDP were more likely to be small for gestational age than the infants of women without HDP (31.7% vs. 10.6%, p < .002).","['Women (n\xa0= 221) and their preterm infants who weighed less than 1,750\xa0g', 'Preterm Infants of Women With Hypertensive Disorders of Pregnancy', 'preterm infants of women with and without HDP', 'Women and their preterm infants were categorized into groups with (n\xa0= 80) and without (control, n\xa0= 141) HDP', 'preterm infants admitted to NICUs', 'preterm infants of women with and without hypertensive disorders of pregnancy (HDP', 'Four NICUs in the United States', 'infants born to women with HDP']",[],"['growth and neurodevelopmental outcomes', 'mean infant height', 'proportion of infants with greater neurologic risk, patent ductus arteriosus, intraventricular hemorrhage, and days on a ventilator', 'Health, Physical Growth, and Neurodevelopmental Outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3495549', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",,0.0787373,"The infants of women with HDP were more likely to be small for gestational age than the infants of women without HDP (31.7% vs. 10.6%, p < .002).","[{'ForeName': 'Forgive', 'Initials': 'F', 'LastName': 'Avorgbedor', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Merwin', 'Affiliation': ''}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Holditch-Davis', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2018.10.003']
465,32191267,Incidence and Progression of Nongeographic Atrophy in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Clinical Trial.,"Importance


Retinal hypopigmentation and hyperpigmentation are precursors of geographic atrophy (GA). Incidence and progression to GA in eyes treated with anti-vascular endothelial growth factor for neovascular age-related macular degeneration (nAMD) have not been investigated.
Objective


To determine the incidence and progression of non-GA (NGA) and associated risk factors.
Design, Setting, and Participants


This study is a post hoc analysis of a cohort study within the Comparison of Age-Related Treatments Trials (CATT) clinical trial. Participants were recruited February 20, 2008, through December 9, 2009; released from protocol follow-up and treatment after 2 years; and recalled from March 14, 2014, through March 31, 2015. Data analyses were conducted from January 11, 2019, through November 27, 2019.
Interventions


Participants were randomized to ranibizumab or bevacizumab for (1) 2 years of monthly or as-needed injections or (2) monthly injections for 1 year and as-needed injections the following year. Participants were treated according to best medical judgement thereafter.
Main Outcomes and Measures


Incidence of nAMD-associated NGA (hypopigmentation and hyperpigmentation in color images) and progression; adjusted risk ratios (aRR) for baseline characteristics.
Results


Among 1107 participants, risk of NGA was 35% (391 eyes), 59% (246 eyes), and 81% (122 eyes) at 1, 2, and 5 years, respectively. Risk factors for NGA included worse visual acuity (20/200-20/320: aRR, 1.74 [95% CI, 1.24-2.43], compared with ≤20/40; P = .006), larger neovascularization area (>4 disc areas: aRR, 1.31 [95% CI, 1.01-1.71], compared with ≤1 disc areas; P = .007), switched drug regimen (aRR, 1.28 [95% CI, 1.06-1.54], compared with as-needed injections; P = .02), and single-nucleotide variants Age-Related Maculopathy Susceptibility 2 (ARMS2) (TT variant: relative risk [RR], 1.53 [95% CI, 1.22-1.93]; P = .001) and HtrA Serine Peptidase 1 (HTRA1) (AG variant: RR, 1.23 [95% CI, 1.01-1.48]; AA variant: RR, 1.51 [95% CI, 1.20-1.91]; P = .002). Sub-retinal pigment epithelium thickness was protective (>275 μm: aRR, 0.59 [95% CI, 0.46-0.75], compared with ≤75 μm; P < .001). Among 389 eyes with NGA by 2 years and subsequent color images, risk of progression to GA was 29%, 43%, and 50% at 1, 3, and 4 years, respectively. Risk factors for progression to GA included worse visual acuity (20/200-20/320: aRR, 2.75 [95% CI, 1.54-4.93], compared with ≤20/40; P < .001), worse fellow-eye visual acuity (<20/40: aRR, 1.77 [95% CI, 1.12-2.79], compared with ≥20/40; P = .01), fellow-eye GA (aRR, 1.71 [95% CI, 1.06-2.75]; P = .03), and pseudodrusen in either eye (aRR, 1.65 [95% CI, 1.17-2.34]; P = .005). Subretinal fluid was associated with a decreased risk of progression (aRR, 0.42 [95% CI, 0.28-0.63]; P < .001).
Conclusions and Relevance


In this study, after 2 years of protocol-guided anti-vascular endothelial growth factor treatment for nAMD, more than half of the eyes in the study developed NGA in the location of nAMD. After 3 additional years of regular care, half of them progressed to GA.
Trial Registration


ClinicalTrials.gov Identifier: NCT00593450.",2020,"Subretinal fluid was associated with a decreased risk of progression (aRR, 0.42 [95% CI, 0.28-0.63]; P < .001).
","['389 eyes with NGA by 2 years and', 'Data analyses were conducted from January 11, 2019, through November 27, 2019', '1107 participants, risk of NGA was 35% (391 eyes), 59% (246 eyes), and 81% (122 eyes) at 1, 2, and 5 years, respectively', 'Participants were recruited February 20, 2008, through December 9, 2009; released from protocol follow-up and treatment after 2 years; and recalled from March 14, 2014, through March 31, 2015']","['anti-vascular endothelial growth factor', 'protocol-guided anti-vascular endothelial growth factor treatment', 'ranibizumab or bevacizumab']","['Incidence and progression to GA', 'subsequent color images, risk of progression to GA', 'Measures\n\n\nIncidence of nAMD-associated NGA (hypopigmentation and hyperpigmentation in color images) and progression; adjusted risk ratios (aRR', 'risk of progression', 'incidence and progression of non-GA (NGA', 'larger neovascularization area', 'fellow-eye GA', 'worse fellow-eye visual acuity', 'Incidence and Progression of Nongeographic Atrophy', 'HtrA Serine Peptidase 1 (HTRA1', 'visual acuity']","[{'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0162835', 'cui_str': 'Hypomelanosis'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0036720', 'cui_str': 'L-serine'}, {'cui': 'C0636538', 'cui_str': 'peptidase-1 (Pleurodeles)'}]",,0.422509,"Subretinal fluid was associated with a decreased risk of progression (aRR, 0.42 [95% CI, 0.28-0.63]; P < .001).
","[{'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Grunwald', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Toth', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0437']
466,32163106,Association of Germline Variant Status With Therapy Response in High-risk Early-Stage Breast Cancer: A Secondary Analysis of the GeparOcto Randomized Clinical Trial.,"Importance


The GeparOcto randomized clinical trial compared the efficacy of 2 neoadjuvant breast cancer (BC) treatment regimens: sequential intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) vs weekly paclitaxel and nonpegylated liposomal doxorubicin (PM) in patients with different biological BC subtypes. Patients with triple-negative BC (TNBC) randomized to the PM arm received additional carboplatin (PMCb). Overall, no difference in pathologic complete response (pCR) rates was observed between study arms. It remained elusive whether the germline variant status of BRCA1/2 and further BC predisposition genes are associated with treatment outcome.
Objective


To determine treatment outcome for BC according to germline variant status.
Design, Setting, and Participants


This retrospective biomarker study is a secondary analysis of the GeparOcto multicenter prospective randomized clinical trial conducted between December 2014 and June 2016. Genetic analyses assessing for variants in BRCA1/2 and 16 other BC predisposition genes in 914 of 945 women were performed at the Center for Familial Breast and Ovarian Cancer, Cologne, Germany, from August 2017 through December 2018.
Main Outcomes and Measures


Proportion of patients who achieved pCR (ypT0/is ypN0 definition) after neoadjuvant treatment according to germline variant status.
Results


In the study sample of 914 women with different BC subtypes with a mean (range) age at BC diagnosis of 48 (21-76) years, overall higher pCR rates were observed in patients with BRCA1/2 variants than in patients without (60.4% vs 46.7%; odds ratio [OR], 1.74; 95% CI, 1.13-2.68; P = .01); variants in non-BRCA1/2 BC predisposition genes were not associated with therapy response. Patients with TNBC with BRCA1/2 variants achieved highest pCR rates. In the TNBC subgroup, a positive BRCA1/2 variant status was associated with therapy response in both the PMCb arm (74.3% vs 47.0% without BRCA1/2 variant; OR, 3.26; 95% CI, 1.44-7.39; P = .005) and the iddEPC arm (64.7% vs 45.0%; OR, 2.24; 95% CI, 1.04-4.84; P = .04). A positive BRCA1/2 variant status was also associated with elevated pCR rates in patients with ERBB2-negative, hormone receptor-positive BC (31.8% vs 11.9%; OR, 3.44; 95% CI, 1.22-9.72; P = .02).
Conclusions and Relevance


Effective chemotherapy for BRCA1/2-mutated TNBC is commonly suggested to be platinum based. With a pCR rate of 64.7%, iddEPC may also be effective in these patients, though further prospective studies are needed. The elevated pCR rate in BRCA1/2-mutated ERBB2-negative, hormone receptor-positive BC suggests that germline BRCA1/2 testing should be considered prior to treatment start.
Trial Registration


ClinicalTrials.gov Identifier: NCT02125344.",2020,"A positive BRCA1/2 variant status was also associated with elevated pCR rates in patients with ERBB2-negative, hormone receptor-positive BC (31.8% vs 11.9%; OR, 3.44; 95% CI, 1.22-9.72; P = .02).
","['patients with different biological BC subtypes', '914 women with different BC subtypes with a mean (range) age at BC diagnosis of 48 (21-76) years', 'Patients with triple-negative BC (TNBC', 'variants in BRCA1/2 and 16 other BC predisposition genes in 914 of 945 women were performed at the Center for Familial Breast and Ovarian Cancer, Cologne, Germany, from August 2017 through December 2018', 'High-risk Early-Stage Breast Cancer', 'December 2014 and June 2016']","['neoadjuvant breast cancer (BC) treatment regimens: sequential intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) vs weekly paclitaxel and nonpegylated liposomal doxorubicin (PM', 'additional carboplatin (PMCb', 'iddEPC']","['pathologic complete response (pCR) rates', 'pCR rates', 'highest pCR rates', 'elevated pCR rates', 'positive BRCA1/2 variant status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",914.0,0.189959,"A positive BRCA1/2 variant status was also associated with elevated pCR rates in patients with ERBB2-negative, hormone receptor-positive BC (31.8% vs 11.9%; OR, 3.44; 95% CI, 1.22-9.72; P = .02).
","[{'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Pohl-Rescigno', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hauke', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Medicine II, Hematology and Oncology, University of Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institut für Pathologie, Philipps-Universität Marburg und Universitätsklinikum Marburg, Marburg, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Kayali', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Ernst', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Weber-Lassalle', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum München, Frauenklinik, Munich, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Hämatologisch-Onkologische Gemeinschaftspraxis, Frankfurt, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Altmüller', 'Affiliation': 'Cologne Center for Genomics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Cologne Center for Genomics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Gynecology and Obstetrics, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lübbe', 'Affiliation': 'Breast Center, Diakovere Henriettenstift, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nürnberg', 'Affiliation': 'Cologne Center for Genomics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Rhiem', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Furlanetto', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Lederer', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum Offenbach GmbH, Offenbach, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Rita K', 'Initials': 'RK', 'LastName': 'Schmutzler', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hahnen', 'Affiliation': 'Center for Familial Breast and Ovarian Cancer, Center for Integrated Oncology, Cologne, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0007']
467,32129815,Short-term Outcomes After Robot-Assisted vs Open Pancreaticoduodenectomy After the Learning Curve.,"Importance


Robot-assisted pancreaticoduodenectomy (RPD) has been reported to be safe and feasible. As a new technique, RPD has a learning curve similar to that of other types of minimally invasive pancreatic surgery such as laparoscopic pancreaticoduodenectomy. To our knowledge, no reports exist on the outcomes of open pancreaticoduodenectomy (OPD) and RPD after the learning curve.
Objective


To analyze and evaluate the actual advantages of RPD.
Design, Setting, and Participants


Between May 2010 and December 2018, 450 patients underwent RPD in the Shanghai Ruijin Hospital affiliated with Shanghai Jiaotong University in Shanghai, China, a high-volume pancreatic disease center. According to our previous study, an important flexion point in the learning curve is 250 cases. Data on the last 200 RPD cases were collected from January 2017 to December 2018. During that period, 634 patients underwent OPD. These patients were divided into 2 groups, and propensity score matching was used to minimize bias. The demographic data and operative outcomes were collected and analyzed. Analysis began May 2019.
Exposures


Robot-assisted pancreaticoduodenectomy and OPD.
Main Outcomes and Measures


The short-term operative outcomes of RPD and OPD.
Results


After 1:1 matching, 187 cases of RPD and OPD were recorded. In the RPD group, 78 patients (41.7%) were women, and the mean (SD) age was 60.9 (11.4) years. In the OPD group, 80 patients (42.8%) were women, and the mean (SD) age was 60.1 (10.8) years. Robot-assisted pancreaticoduodenectomy had advantages in operative time (mean [SD], 279.7 [76.3] minutes vs 298.2 [78.3] minutes; P = .02), estimated blood loss (mean [SD], 297.3 [246.8] mL vs 415.2 [497.9] mL; P = .002), and postoperative length of hospital stay (mean [SD], 22.4 [16.7] days vs 26.1 [16.3] days; P = .03). However, there was no significant difference in the R0 resection rate and incidence rate of postoperative complications, such as postoperative pancreatic fistula, bile leak, and delayed gastric emptying. The incidence rates of postoperative bleeding and reoperation in the RPD group were similar to those in the OPD group, with no statistically significant difference.
Conclusions and Relevance


After passing the learning curve, RPD had advantages in operative time and blood loss compared with OPD. There were no differences in postoperative complications such as postoperative pancreatic fistula, bile leak, and delayed gastric emptying. However, patients recovered more quickly after RPD than after OPD. A prospective randomized clinical trial is needed in the future to verify these results.",2020,"The incidence rates of postoperative bleeding and reoperation in the RPD group were similar to those in the OPD group, with no statistically significant difference.
","['200 RPD cases were collected from January 2017 to December 2018', 'Between May 2010 and December 2018, 450 patients underwent RPD in the Shanghai Ruijin Hospital affiliated with Shanghai Jiaotong University in Shanghai, China, a high-volume pancreatic disease center', '634 patients underwent OPD', '80 patients (42.8%) were women, and the mean (SD) age was 60.1\u2009(10.8) years', '78 patients (41.7%) were women, and the mean (SD) age was 60.9\u2009(11.4) years']","['Importance\n\n\nRobot-assisted pancreaticoduodenectomy (RPD', 'Robot-Assisted vs Open Pancreaticoduodenectomy', 'Exposures\n\n\nRobot-assisted pancreaticoduodenectomy and OPD']","['estimated blood loss', 'incidence rates of postoperative bleeding and reoperation', 'postoperative length of hospital stay', 'R0 resection rate and incidence rate of postoperative complications, such as postoperative pancreatic fistula, bile leak, and delayed gastric emptying', 'postoperative complications such as postoperative pancreatic fistula, bile leak, and delayed gastric emptying', 'operative time', 'operative time and blood loss']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030286', 'cui_str': 'Pancreatic Diseases'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517533', 'cui_str': '11.4'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",634.0,0.030752,"The incidence rates of postoperative bleeding and reoperation in the RPD group were similar to those in the OPD group, with no statistically significant difference.
","[{'ForeName': 'Yusheng', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiabin', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yuanchi', 'Initials': 'Y', 'LastName': 'Weng', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Qin', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaxing', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chenghong', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Baiyong', 'Initials': 'B', 'LastName': 'Shen', 'Affiliation': 'Pancreatic Disease Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}]",JAMA surgery,['10.1001/jamasurg.2020.0021']
468,31511288,"Fatigue, quality of life and metabolic changes in men treated with first-line enzalutamide versus abiraterone plus prednisolone for metastatic castration-resistant prostate cancer (HEAT): a randomised trial protocol.","INTRODUCTION


Enzalutamide and abiraterone acetate plus prednisolone (AAP) are used in combination with androgen-deprivation therapy to further suppress the androgen stimulation of metastatic castration-resistant prostate cancer (mCRPC). First-line mCRPC treatment with enzalutamide and AAP yields similar overall survival and radiographic progression-free survival in phase III trials. Thus, treatment selection relies on patient choice, cost and side effects. The aim of this randomised trial is to investigate differences in fatigue, health-related quality of life (HRQoL) and metabolic side effects in men with mCRPC treated with first-line enzalutamide versus AAP.
METHODS AND ANALYSIS


In this ongoing open-label randomised (1:1) clinical trial, enzalutamide is compared with AAP as first-line treatment for men with mCRPC. The primary endpoint is fatigue assessed with the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue version 4. Secondary endpoints are changes in body composition (ie, fat mass, visceral adipose tissue, subcutaneous adipose tissue and lean body mass assessed with dual energy X-ray absorptiometry), glucose metabolism assessed with a 2-hour oral glucose tolerance test, serum lipids, blood pressure and HRQoL assessed with the questionnaire Functional Assessment of Cancer Therapy-Prostate (FACT-P). All study endpoints are assessed at baseline and 12-week postintervention. Blood and urine samples are collected at baseline and at time of progression on allocated treatment for future investigation of predictive and prognostic biomarkers in prostate cancer treatment. The planned sample size is 170 participants. All participants are recruited from Herlev and Gentofte Hospital, Denmark. Estimated last patient's last visit is February 2020.
ETHICS AND DISSEMINATION


The study received project approval from the National Committee on Health Research Ethics and Danish Data Protection Agency and Danish Medicines Agency (EudraCT no.: 2017-000027-99). The results of the study will be published in peer-reviewed international journals and will be presented at national and international conferences and symposiums.
TRIAL REGISTRATION NUMBER


Clinicaltrialsregister.eu (2017-000099-27).",2019,First-line mCRPC treatment with enzalutamide and AAP yields similar overall survival and radiographic progression-free survival in phase III trials.,"['men with mCRPC', 'metastatic castration-resistant prostate cancer (HEAT', 'All participants are recruited from Herlev and Gentofte Hospital, Denmark', 'men treated with first-line', '170 participants', 'men with mCRPC treated with first-line enzalutamide versus AAP']","['enzalutamide versus abiraterone plus prednisolone', 'enzalutamide', 'enzalutamide and AAP', 'Enzalutamide and abiraterone acetate plus prednisolone (AAP']","['overall survival and radiographic progression-free survival', 'fatigue, health-related quality of life (HRQoL) and metabolic side effects', 'fatigue assessed with the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue version 4', 'changes in body composition (ie, fat mass, visceral adipose tissue, subcutaneous adipose tissue and lean body mass assessed with dual energy X-ray absorptiometry), glucose metabolism assessed with a 2-hour oral glucose tolerance test, serum lipids, blood pressure and HRQoL assessed with the questionnaire Functional Assessment of Cancer Therapy-Prostate (FACT-P', 'Fatigue, quality of life and metabolic changes']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",170.0,0.139383,First-line mCRPC treatment with enzalutamide and AAP yields similar overall survival and radiographic progression-free survival in phase III trials.,"[{'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Kvorning Ternov', 'Affiliation': 'Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark klara.kvorning.ternov@regionh.dk.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sønksen', 'Affiliation': 'Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Fode', 'Affiliation': 'Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Lindberg', 'Affiliation': 'Department of Oncology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Caroline Michaela', 'Initials': 'CM', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Bisbjerg', 'Affiliation': 'Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Palapattu', 'Affiliation': 'Department of Urology, Michigan Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Peter Busch', 'Initials': 'PB', 'LastName': 'Østergren', 'Affiliation': 'Department of Urology, Herlev and Gentofte Hospital, Herlev, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-030218']
469,30285177,Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial.,"Importance


Despite recent studies suggesting arthroscopic partial meniscectomy (APM) is not more effective than physical therapy (PT), the procedure is still frequently performed in patients with meniscal tears.
Objective


To assess whether PT is noninferior to APM for improving patient-reported knee function in patients with meniscal tears.
Design, Setting, and Participants


Noninferiority, multicenter, randomized clinical trial conducted in 9 hospitals in the Netherlands. Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint). Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded. Recruitment took place between July 17, 2013, and November 4, 2015. Participants were followed up for 24 months (final participant follow-up, October 11, 2017).
Interventions


Three hundred twenty-one participants were randomly assigned to APM (n = 159) or a predefined PT protocol (n = 162). The PT protocol consisted of 16 sessions of exercise therapy over 8 weeks focused on coordination and closed kinetic chain strength exercises.
Main Outcomes and Measures


The primary outcome was change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100; from worse to best) from baseline over a 24-month follow-up period. The noninferiority margin was defined as a difference between treatment groups of 8 points and was assessed with a 1-sided α of .025. The primary analysis followed the intention-to-treat principle.
Results


Among 321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men). In the PT group, 47 participants (29%) had APM during the 24-month follow-up period, and 8 participants randomized to APM (5%) did not have APM. Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7). The overall between-group difference was 3.6 points (97.5% CI, -∞ to 6.5; P value for noninferiority = .001). Adverse events occurred in 18 participants in the APM group and 12 in the PT group. Repeat surgery (3 in the APM group and 1 in the PT group) and additional outpatient visits for knee pain (6 in the APM group and 2 in the PT group) were the most frequent adverse events.
Conclusions and Relevance


Among patients with nonobstructive meniscal tears, PT was noninferior to APM for improving patient-reported knee function over a 24-month follow-up period. Based on these results, PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears.
Trial Registration


ClinicalTrials.gov Identifier: NCT01850719.",2018,"Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7).","['Patients With Nonobstructive Meniscal Tears', 'patients with meniscal tears', '9 hospitals in the Netherlands', 'Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint', 'Interventions\n\n\nThree hundred twenty-one participants', 'patients with nonobstructive meniscal tears', 'Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded', '321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men']","['APM', 'exercise therapy', 'arthroscopic partial meniscectomy (APM', 'Early Surgery vs Physical Therapy', 'predefined PT protocol', 'PT']","['APM', 'Adverse events', 'Knee Function', 'change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100', 'knee function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]",161.0,0.109593,"Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7).","[{'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'van de Graaf', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Julia C A', 'Initials': 'JCA', 'LastName': 'Noorduyn', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Nienke W', 'Initials': 'NW', 'LastName': 'Willigenburg', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ise K', 'Initials': 'IK', 'LastName': 'Butter', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'de Gast', 'Affiliation': 'Department of Orthopedic Surgery, Clinical Orthopedic Research Center-mN, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniel B F', 'Initials': 'DBF', 'LastName': 'Saris', 'Affiliation': 'Department of Orthopedic Surgery, UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'currently with Department of Clinical Epidemiology and Biostatistics, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Department of Orthopedic Surgery, Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2018.13308']
470,32175586,Influence of Acetazolamide on Hand Strength and Manual Dexterity During a 30-h Simulated High Altitude Exposure.,"INTRODUCTION


High altitude missions pose significant challenges to Warfighter medical readiness and performance. Decreased circulating oxygen levels cause a decrease in exercise performance and can cause debilitating symptoms associated with acute mountain sickness, especially with rapid ascent. Acetazolamide (AZ) is known to minimize symptoms of acute mountain sickness, but it is unknown whether this medication alters hand strength and manual dexterity during altitude exposure.
MATERIALS AND METHODS


Ten male volunteers (22 ± 4 yr, 75.9 ± 13.7 kg, 174.9 ± 9.3 cm) participated in two separate 30 h simulated altitude exposures (496 mmHg, equivalent to 3,500 m, 20°C, 20% RH) in a hypobaric chamber. Participants were given either a placebo or 250 mg of AZ twice daily for 3.5 d (2 sea-level [SL] days + the 30 h altitude exposure) in a randomized, single-blind, crossover design. During SL and both altitude (ALT) exposures, hand function tests were performed, including hand grip and finger pinch strength tests, as well as the Purdue Pegboard (PP) and magazine loading tests to assess manual dexterity. Paired T tests and two-way repeated measure analysis of variance were used as appropriate to evaluate the effects of AZ and ALT. The value of p < 0.05 was accepted for statistical significance.
RESULTS


There were no influences of acute ALT exposure or AZ treatment on hand strength (eg, grip strength; SL: 39.2 ± 5.5 kg vs. ALT: 41.5 ± 6.9 kg, p > 0.05) or dexterity (eg, PPassembly; placebo: 35.5 ± 5.3 vs. AZ: 34.3 ± 4.6, p > 0.05) in our volunteers. Two dexterity tests (PPsum and magazine loading) showed improvements over time at ALT, regardless of treatment, where scores were improved after 10 h of exposure compared to at 1 h (eg, magazine loading: 56 ± 12 vs. 48 ± 10, p < 0.001). This pattern was not seen in the PPassembly test or any strength measurements.
CONCLUSIONS


Our results suggest that 500 mg/d of AZ does not influence hand strength or manual dexterity during a 30 h exposure to 3,500 m simulated ALT. Acute ALT exposure (1 h) did not influence dexterity or strength, although some measures of dexterity showed improvements as exposure time increased. We conclude that use of AZ to optimize medical readiness at ALT is unlikely to impair the Warfighter's ability to complete mission tasks that depend on hand function.",2020,"Acute ALT exposure (1 h) did not influence dexterity or strength, although some measures of dexterity showed improvements as exposure time increased.","['Ten male volunteers (22\xa0±\xa04\xa0yr, 75.9\xa0±\xa013.7\xa0kg, 174.9\xa0±\xa09.3\xa0cm) participated in two separate 30\xa0h simulated altitude exposures (496\xa0mmHg, equivalent to 3,500\xa0m, 20°C, 20% RH) in a hypobaric chamber']","['Acetazolamide (AZ', 'AZ', 'placebo or 250\xa0mg of AZ', 'Acetazolamide']","['dexterity or strength', 'hand strength or manual dexterity', 'Hand Strength and Manual Dexterity', 'acute ALT exposure or AZ treatment on hand strength']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0179879', 'cui_str': 'Hypobaric chamber (physical object)'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",10.0,0.0161299,"Acute ALT exposure (1 h) did not influence dexterity or strength, although some measures of dexterity showed improvements as exposure time increased.","[{'ForeName': 'Beau R', 'Initials': 'BR', 'LastName': 'Yurkevicius', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Karleigh E', 'Initials': 'KE', 'LastName': 'Bradbury', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Nixon', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Mitchell', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Luippold', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Mayer', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Billie K', 'Initials': 'BK', 'LastName': 'Alba', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Salgado', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}]",Military medicine,['10.1093/milmed/usaa041']
471,31999296,High-Dose Chemotherapy With Hematopoietic Stem Cell Transplant in Patients With High-Risk Breast Cancer and 4 or More Involved Axillary Lymph Nodes: 20-Year Follow-up of a Phase 3 Randomized Clinical Trial.,"Importance


Trials of adjuvant high-dose chemotherapy (HDCT) have failed to show a survival benefit in unselected patients with breast cancer, but long-term follow-up is lacking.
Objective


To determine 20-year efficacy and safety outcomes of a large trial of adjuvant HDCT vs conventional-dose chemotherapy (CDCT) for patients with stage III breast cancer.
Design, Setting, and Participants


This secondary analysis used data from a randomized phase 3 multicenter clinical trial of 885 women younger than 56 years with breast cancer and 4 or more involved axillary lymph nodes conducted from August 1, 1993, to July 31, 1999. Additional follow-up data were collected between June 1, 2016, and December 31, 2017, from medical records, general practitioners, the Dutch national statistical office, and nationwide cancer registries. Analysis was performed on an intention-to-treat basis. Statistical analysis was performed from February 1, 2018, to October 14, 2019.
Interventions


Participants were randomized 1:1 to receive 5 cycles of CDCT consisting of fluorouracil, 500 mg/m2, epirubicin, 90 mg/m2, and cyclophosphamide, 500 mg/m2, or HDCT in which the first 4 cycles were identical to CDCT and the fifth cycle was replaced by cyclophosphamide, 6000 mg/m2, thiotepa, 480 mg/m2, and carboplatin, 1600 mg/m2, followed by hematopoietic stem cell transplant.
Main Outcomes and Measures


Main end points were overall survival and safety and cumulative incidence risk of a second malignant neoplasm or cardiovascular events.
Results


Of the 885 women in the study (mean [SD] age, 44.5 [6.6] years), 442 were randomized to receive HDCT, and 443 were randomized to receive CDCT. With 20.4 years median follow-up (interquartile range, 19.2-22.0 years), the 20-year overall survival was 45.3% with HDCT and 41.5% with CDCT (hazard ratio, 0.89; 95% CI, 0.75-1.06). The absolute improvement in 20-year overall survival was 14.6% (hazard ratio, 0.72; 95% CI, 0.54-0.95) for patients with 10 or more invoved axillary lymph nodes and 15.4% (hazard ratio, 0.67; 95% CI, 0.42-1.05) for patients with triple-negative breast cancer. The cumulative incidence risk of a second malignant neoplasm at 20 years or major cardiovascular events was similar in both treatment groups (20-year cumulative incidence risk for second malignant neoplasm was 12.1% in the HDCT group vs 16.2% in the CDCT group, P = .10), although patients in the HDCT group more often had hypertension (21.7% vs 14.3%, P = .02), hypercholesterolemia (15.7% vs 10.6%, P = .04), and dysrhythmias (8.6% vs 4.6%, P = .005).
Conclusions and Relevance


High-dose chemotherapy provided no long-term survival benefit in unselected patients with stage III breast cancer but did provide improved overall survival in very high-risk patients (ie, with ≥10 involved axillary lymph nodes). High-dose chemotherapy did not affect long-term risk of a second malignant neoplasm or major cardiovascular events.
Trial Registration


ClinicalTrials.gov Identifier: NCT03087409.",2020,"The absolute improvement in 20-year overall survival was 14.6% (hazard ratio, 0.72; 95% CI, 0.54-0.95) for patients with 10 or more invoved axillary lymph nodes and 15.4% (hazard ratio, 0.67; 95% CI, 0.42-1.05) for patients with triple-negative breast cancer.","['885 women in the study (mean [SD] age, 44.5 [6.6] years', 'Patients With High-Risk Breast Cancer and 4 or More Involved Axillary Lymph Nodes', 'patients with stage III breast cancer', '885 women younger than 56 years with breast cancer and 4 or more involved axillary lymph nodes conducted from August 1, 1993, to July 31, 1999', 'Additional follow-up data were collected between June 1, 2016, and December 31, 2017, from medical records, general practitioners, the Dutch national statistical office, and nationwide cancer registries', 'unselected patients with breast cancer', 'unselected patients with stage III breast cancer']","['High-dose chemotherapy', 'adjuvant high-dose chemotherapy (HDCT', 'adjuvant HDCT vs conventional-dose chemotherapy (CDCT', 'cyclophosphamide, 6000 mg/m2, thiotepa, 480 mg/m2, and carboplatin', 'High-Dose Chemotherapy With Hematopoietic Stem Cell Transplant', 'CDCT consisting of fluorouracil, 500 mg/m2, epirubicin, 90 mg/m2, and cyclophosphamide, 500 mg/m2, or HDCT', 'CDCT', 'HDCT']","['hypertension', 'dysrhythmias', 'cumulative incidence risk of a second malignant neoplasm at 20 years or major cardiovascular events', 'overall survival and safety and cumulative incidence risk of a second malignant neoplasm or cardiovascular events', 'hypercholesterolemia', 'overall survival', '20-year overall survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node structure (body structure)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3842326', 'cui_str': 'Six thousand'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}]","[{'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]",885.0,0.402943,"The absolute improvement in 20-year overall survival was 14.6% (hazard ratio, 0.72; 95% CI, 0.54-0.95) for patients with 10 or more invoved axillary lymph nodes and 15.4% (hazard ratio, 0.67; 95% CI, 0.42-1.05) for patients with triple-negative breast cancer.","[{'ForeName': 'Tessa G', 'Initials': 'TG', 'LastName': 'Steenbruggen', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Lars C', 'Initials': 'LC', 'LastName': 'Steggink', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Seynaeve', 'Affiliation': 'Department of Medical Oncology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jacobus J M', 'Initials': 'JJM', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Maartje J', 'Initials': 'MJ', 'LastName': 'Hooning', 'Affiliation': 'Department of Medical Oncology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jager', 'Affiliation': 'Department of Medical Oncology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Inge R', 'Initials': 'IR', 'LastName': 'Konings', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, location VUmc, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Judith R', 'Initials': 'JR', 'LastName': 'Kroep', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wim M', 'Initials': 'WM', 'LastName': 'Smit', 'Affiliation': 'Department of Internal Medicine/Medical Oncology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Vivianne C G', 'Initials': 'VCG', 'LastName': 'Tjan-Heijnen', 'Affiliation': 'Department of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Elsken', 'Initials': 'E', 'LastName': 'van der Wall', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Adriaan D', 'Initials': 'AD', 'LastName': 'Bins', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schaapveld', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Judy N', 'Initials': 'JN', 'LastName': 'Jacobse', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Flora E', 'Initials': 'FE', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Carolien P', 'Initials': 'CP', 'LastName': 'Schröder', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Department of Biostatistics, the Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Elisabeth G E', 'Initials': 'EGE', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gabe S', 'Initials': 'GS', 'LastName': 'Sonke', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, the Netherlands.'}, {'ForeName': 'Jourik A', 'Initials': 'JA', 'LastName': 'Gietema', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6276']
472,31999308,Development of a Sleep Apnea-Specific Health State Utility Algorithm.,"Importance


With the increasing emphasis on economic evaluations, there is a need for additional methods of measuring patient utility in the obstructive sleep apnea population.
Objective


To develop and validate a utility scoring algorithm for a sleep apnea-specific quality-of-life instrument.
Design, Setting, and Participants


Development and validation were conducted at 2 tertiary referral sleep centers and associated sleep clinics and included patients with newly diagnosed obstructive sleep apnea from a randomized clinical trial and an associated observational cohort study. Baseline participants were randomly divided into a model development group (60%) and a cross-validation group (40%).
Main Outcomes and Measures


Utility scoring of the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) was mapped from the SF-6D utility index through multiple linear regression in the development sample using the Akaike information criterion to determine the best model.
Results


A total of 500 participants (development, n = 300; validation, n = 200) were enrolled; the analyzed sample of 500 participants included 295 men (59%), and the mean (SD) age was 48.6 (12.8) years, with a range of 18 to 90 years. The mean (SD) SF-6D utility among participants with untreated sleep apnea was 0.61 (0.08; range, 0.40-0.85) with similar utility across sleep apnea severity groups. The best-fit model (the SNORE Utility Index) was the natural log conversion of the instrument subscales (r2 = 0.32 in the development sample). The SNORE Utility Index retained this association within the validation sample (r2 = 0.33).
Conclusions and Relevance


The SNORE Utility Index provides a validated, disease-specific, preference-weighted utility instrument that can be used in future studies of patients with obstructive sleep apnea.",2020,"The mean (SD) SF-6D utility among participants with untreated sleep apnea was 0.61 (0.08; range, 0.40-0.85) with similar utility across sleep apnea severity groups.","['patients with obstructive sleep apnea', 'Participants\n\n\nDevelopment and validation were conducted at 2 tertiary referral sleep centers and associated sleep clinics and included patients with newly diagnosed obstructive sleep apnea from a randomized clinical trial and an associated observational cohort study', 'obstructive sleep apnea population', '500 participants (development, n\u2009=\u2009300; validation, n\u2009=\u2009200) were enrolled; the analyzed sample of 500 participants included 295 men (59%), and the mean (SD) age was 48.6 (12.8) years, with a range of 18 to 90 years']",[],"['Measures\n\n\nUtility scoring of the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25', 'mean (SD) SF-6D utility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",[],"[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0037384', 'cui_str': 'Snorings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",500.0,0.0226285,"The mean (SD) SF-6D utility among participants with untreated sleep apnea was 0.61 (0.08; range, 0.40-0.85) with similar utility across sleep apnea severity groups.","[{'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Skirko', 'Affiliation': 'Division of Otolaryngology-Head & Neck Surgery, Department of Surgery, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'James', 'Affiliation': 'Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Garrison', 'Affiliation': 'Pharmaceutical Outcomes Research and Policy Program, School of Pharmacy, University of Washington, Seattle.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Weaver', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Washington, Seattle.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.4469']
473,32074268,Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs Appendectomy for Uncomplicated Acute Appendicitis: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Long-term results support antibiotics for uncomplicated acute appendicitis as an alternative to appendectomy. To our knowledge, treatment-related long-term patient satisfaction and quality of life (QOL) are not known.
Objective


To determine patient satisfaction and QOL after antibiotic therapy and appendectomy for treating uncomplicated acute appendicitis.
Interventions


Open appendectomy vs antibiotics with intravenous ertapenem, 1 g once daily, for 3 days followed by 7 days of oral levofloxacin, 500 mg once daily, and metronidazole, 500 mg 3 times per day.
Design, Setting, and Participants


This observational follow-up of the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotics included 530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or receive antibiotics (257 [49%]). The trial was conducted from November 2009 to June 2012; the last follow-up was May 9, 2018. The data were analyzed in February 2019.
Main Outcomes and Measures


In this analysis, post hoc secondary end points of postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference were evaluated.
Results


Of the 530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent appendectomy. Of the 206 patients taking antibiotics, 81 (39%) had undergone appendectomy. The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96). Patients who underwent appendectomy were more satisfied in the treatment than patients taking antibiotics (68% very satisfied, 21% satisfied, 6% indifferent, 4% unsatisfied, and 1% very unsatisfied in the appendectomy group and 53% very satisfied, 21% satisfied, 13% indifferent, 7% unsatisfied, and 6% very unsatisfied in the antibiotic group; P < .001) and in a subgroup analysis this difference was based on the antibiotic group patients undergoing appendectomy. There was no difference in patient satisfaction after successful antibiotic treatment compared with appendectomy (cumulative odds ratio [COR], 7.8; 95% CI, 0.5-1.3; P < .36). Patients with appendectomy or with successful antibiotic therapy were more satisfied than antibiotic group patients who later underwent appendectomy (COR, 7.7; 95% CI, 4.6-12.9; P < .001; COR, 9.7; 95% CI, 5.4-15.3; P < .001, respectively). Of the 81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment.
Conclusions and Relevance


In this analysis, long-term QOL was similar after appendectomy and antibiotic therapy for the treatment of uncomplicated acute appendicitis. Patients taking antibiotics who later underwent appendectomy were less satisfied than patients with successful antibiotics or appendectomy.
Trial Registration


Clinicaltrials.gov Identifier: NCT01022567.",2020,"The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96).","['530 patients age 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis who were randomized to undergo appendectomy (273 [52%]) or', '530 patients enrolled in the trial (appendectomy group: 273 [174 men (64%)] with a median age of 35 years; (antibiotic group: 257 [155 men (60%)] with a median age of 33 years), 423 patients (80%) were available for phone interview at a median follow-up of 7 years; 206 patients (80%) took antibiotics and 217 (79%) underwent', '81 patients taking antibiotics who underwent appendectomy, 27 (33%) would again choose antibiotics as their primary treatment', 'uncomplicated acute appendicitis', 'Patients with appendectomy or with', 'Uncomplicated Acute Appendicitis', '206 patients taking antibiotics, 81 (39%) had undergone appendectomy']","['appendectomy and antibiotic therapy', 'successful antibiotic therapy', 'Interventions\n\n\nOpen appendectomy vs antibiotics with intravenous ertapenem', 'appendectomy with antibiotics', 'receive antibiotics', 'levofloxacin', 'metronidazole', 'appendectomy', 'Antibiotic Therapy vs Appendectomy', 'antibiotic therapy and appendectomy']","['quality of life (QOL', 'patient satisfaction', 'QOL', 'Quality of Life and Patient Satisfaction', 'postintervention QOL (EQ-5D-5L) and patient satisfaction and treatment preference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085693', 'cui_str': 'Acute appendicitis'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1120106', 'cui_str': 'ertapenem'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",530.0,0.154225,"The QOL between appendectomy and antibiotic group patients was similar (median health index value, 1.0 in both groups; 95% CI, 0.86-1.0; P = .96).","[{'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Sippola', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Haijanen', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Viinikainen', 'Affiliation': 'Department of Surgery, University of Turku, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Grönroos', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Paajanen', 'Affiliation': 'Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Aarnio', 'Affiliation': 'Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Hurme', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Mecklin', 'Affiliation': 'Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Sand', 'Affiliation': 'Department of Health and Medical Services, Päijät-Häme Joint Authority for Health and Wellbeing, Lahti, Finland.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Jartti', 'Affiliation': 'Department of Radiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Salminen', 'Affiliation': 'Turku University Hospital, Division of Digestive Surgery and Urology, University of Turku, Turku, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2019.6028']
474,32077909,Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial.,"Importance


Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy.
Objective


To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy.
Design, Setting, and Participants


This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019.
Interventions


Intraocular lens implantation at the time of cataract surgery.
Main Outcomes and Measures


Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis.
Results


Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was -0.54 to 0.47).
Conclusions and Relevance


As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome.
Trial Registration


ClinicalTrials.gov Identifier: NCT00212134.",2020,"Overall, 27 of the children (25%) had good (logMAR 0.30","['participants included 58 girls (53%) and 52 boys (47', 'children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019', '114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age', 'unilateral cataract surgery during infancy']","['contact lens vs IOL correction', 'Intraocular Lens vs Contact Lens Correction', 'Cataract Surgery', 'intraocular lenses (IOLs', 'Interventions\n\n\nIntraocular lens implantation']","['Results\n\n\nBest-corrected visual acuity', 'excellent visual acuity', 'Visual Acuity', 'median logMAR acuity', 'Main Outcomes and Measures\n\n\nBest-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol', 'visual acuity outcomes', 'visual acuity of logMAR', 'median visual acuity', 'better) visual acuity']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0009691', 'cui_str': 'Congenital cataract (disorder)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}]","[{'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0023311', 'cui_str': 'Lens Implantation, Intraocular'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",114.0,0.530132,"Overall, 27 of the children (25%) had good (logMAR 0.30","[{'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Lindreth', 'Initials': 'L', 'LastName': 'DuBois', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam Ms', 'Affiliation': 'Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Stacey J', 'Initials': 'SJ', 'LastName': 'Kruger', 'Affiliation': 'Department of Ophthalmology, Northwell Health, Great Neck, New York.'}, {'ForeName': 'E Eugenie', 'Initials': 'EE', 'LastName': 'Hartmann', 'Affiliation': ""Rebecca D. Considine Research Institute and Vision Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Weakley', 'Affiliation': 'Department of Ophthalmology, University of Texas, Southwestern Medical Center, Dallas.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Drews-Botsch', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0006']
475,32160071,Consumption of Nopal Powder in Adult Women.,"Osteoporosis is a chronic disease in adult women caused by menopause and some other factors, which entails deficiency of calcium in diet. Natural products are the best source of nutriments to reduce the risk of chronic diseases. Nopal ( Opuntia ficus-indica ) is a plant characterized by its nutritional components and benefits to health. Its calcium content increases with maturation process that could be beneficial for consumers. Nopal powder (NP) was elaborated from nopal harvested within 16-24 weeks of maturation, and the nutritional content was determined. An experimental clinical trial was performed to evaluate the effect of NP. A total of 69 women between 40 and 60 years old participated in the study. During 24 weeks, experimental group ( n  = 56) consumed a daily dose of 5 g of NP and control group ( n  = 13) continue with habitual diet. Changes in bone mineral density (BMD), body mass index (BMI), body fat percentage and serum calcium were assessed. Between baseline and after 24 weeks of consumption, no significant changes were found in BMD  P  = .885 experimental group and  P  = .970 control group, BMI  P  = .865 experimental group and  P  = .984 control group, body fat  P  = .744 experimental group and  P  = .740 control group and serum calcium  P  = .282 experimental group and  P  = .959 control group. These results indicate that advanced maturation NP does not have influence in bone health, BMI, and body composition in adult women.",2020,"Between baseline and after 24 weeks of consumption, no significant changes were found in BMD  P  = .885 experimental group and  P  = .970 control group, BMI  P  = ","['69 women between 40 and 60 years old participated in the study', 'Adult Women', 'adult women']","['Nopal powder (NP', 'NP and control group ( n \u2009=\u200913) continue with habitual diet']","['bone health, BMI, and body composition', 'BMD', 'bone mineral density (BMD), body mass index (BMI), body fat percentage and serum calcium']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}]",69.0,0.0238556,"Between baseline and after 24 weeks of consumption, no significant changes were found in BMD  P  = .885 experimental group and  P  = .970 control group, BMI  P  = ","[{'ForeName': 'Mayra Elisa', 'Initials': 'ME', 'LastName': 'Sánchez-Murillo', 'Affiliation': 'Autonomous University of Nuevo Leon, Biological Sciences School, San Nicolás de los Garza, Nuevo León, Mexico.'}, {'ForeName': 'Edwyn Omar', 'Initials': 'EO', 'LastName': 'Cruz-López', 'Affiliation': 'Autonomous University of Nuevo Leon, Phytotherapy Laboratory, School of Public Health and Nutrition, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'María Julia', 'Initials': 'MJ', 'LastName': 'Verde-Star', 'Affiliation': 'Autonomous University of Nuevo Leon, Biological Sciences School, San Nicolás de los Garza, Nuevo León, Mexico.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Rivas-Morales', 'Affiliation': 'Autonomous University of Nuevo Leon, Biological Sciences School, San Nicolás de los Garza, Nuevo León, Mexico.'}, {'ForeName': 'María Eufemia', 'Initials': 'ME', 'LastName': 'Morales-Rubio', 'Affiliation': 'Autonomous University of Nuevo Leon, Biological Sciences School, San Nicolás de los Garza, Nuevo León, Mexico.'}, {'ForeName': 'Aurora de Jesús', 'Initials': 'AJ', 'LastName': 'Garza-Juárez', 'Affiliation': 'Autonomous University of Nuevo Leon, School of Medicine, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Jorge Martín', 'Initials': 'JM', 'LastName': 'Llaca-Díaz', 'Affiliation': 'Autonomous University of Nuevo Leon, University Hospital ""Dr. José Eleuterio González,"" School of Medicine, Monterrey, Nuevo León, Mexico.'}, {'ForeName': 'Ma de Jesús', 'Initials': 'MJ', 'LastName': 'Ibarra-Salas', 'Affiliation': 'Autonomous University of Nuevo Leon, Phytotherapy Laboratory, School of Public Health and Nutrition, Monterrey, Nuevo León, Mexico.'}]",Journal of medicinal food,['10.1089/jmf.2019.0244']
476,32402554,"Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).","PURPOSE


Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.
DESIGN


Multicenter cohort study.
PARTICIPANTS


Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion).
METHODS


Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit.
MAIN OUTCOME MEASURES


Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST).
RESULTS


Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0-12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3-14.5) better than baseline but 4.8 letters (95% CI, 2.5-7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4-5.0) better than baseline but 4.6 letters (95% CI, 3.1-6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142-166) and was stable between 2 and 5 years (-1 μm; 95% CI, -12 to 9).
CONCLUSIONS


Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.",2020,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","['Participants', 'Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion', 'for center-involved diabetic macular edema (CI-DME', 'eyes with DME']","['anti-VEGF therapy', 'aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment', 'Aflibercept, Bevacizumab, or Ranibizumab']","['Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST', '5-year visit, mean VA', '5-year visit', 'mean 5-year VA', 'Mean CST', 'mean retinal thickness', 'mean VA']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",,0.306087,"At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9-9.0) but decreased by 4.7 letters (95% CI, 3.3-6.0) between 2 and 5 years.","[{'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, Columbia, South Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Josic', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Antoszyk', 'Affiliation': 'Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, North Carolina.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Elman', 'Affiliation': 'Elman Retina Group, Pikesville, Maryland.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts.'}]",Ophthalmology,['10.1016/j.ophtha.2020.03.021']
477,32402732,Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial.,"BACKGROUND


Liposomal bupivacaine (LB), as an extended-release local anesthetic, may provide lasting pain control and therefore decrease the need for narcotics in the immediate postoperative period.
OBJECTIVES


The aim of this study was to evaluate whether transversus abdominis plane (TAP) block with LB decreased the use of postoperative narcotics compared with regular bupivacaine (RB) and no TAP block in patients undergoing weight loss procedures.
SETTING


A large, metropolitan, university-affiliated, tertiary hospital.
METHODS


Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year were randomized to receive TAP block using LB, TAP block with RB, or no block in a double-blind, randomized controlled trial. The outcomes measured were postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea. Data were analyzed using χ 2  test and analysis of variance F test.
RESULTS


Two hundred nineteen patients were included in the study. Fentanyl patient-controlled analgesia usage was not significantly different between the groups (LB 351.4 versus RB 360.7 versus no TAP block 353.9, P = .97) at 48 hours post operation. The pain scores (scale 1-10) were similar among the groups with the mean for the LB group at 4.3, and RB and no TAP block groups both at 4.7 (P = .35). The type of block or lack of block did not significantly impact the length of stay, time to ambulation, or presence of nausea.
CONCLUSION


The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.",2020,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"['A large, metropolitan, university-affiliated, tertiary hospital', 'opiate use after weight loss surgery', 'patients undergoing weight loss procedures', 'Two hundred nineteen patients were included in the study', 'Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year']","['transversus abdominis plane (TAP) block with LB', 'regular bupivacaine (RB) and no TAP block', 'Liposomal bupivacaine (LB', 'TAP block using LB, TAP block with RB, or no block', 'liposomal bupivacaine']","['Fentanyl patient-controlled analgesia usage', 'pain scores', 'length of stay, time to ambulation, or presence of nausea', 'postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea', 'total opiate pain medication consumption']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",219.0,0.208823,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"[{'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Ana Garcia', 'Initials': 'AG', 'LastName': 'Cabrera', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Argiroff', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pechman', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Vazzana', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Moran-Atkin', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jenny J', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Diego R', 'Initials': 'DR', 'LastName': 'Camacho', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York. Electronic address: Dicamach@montefiore.org.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.03.031']
478,32401589,Re: Randomised Clinical Trial of Prostate Artery Embolisation versus a Sham Procedure for Benign Prostatic Hyperplasia.,,2020,,['Benign Prostatic Hyperplasia'],['Prostate Artery Embolisation'],[],"[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]",[],,0.264533,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100']
479,32401590,Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate: Subgroup Analysis from a Blinded Randomized Trial.,,2020,,[],['Re: Symptom Relief and Anejaculation after Aquablation or Transurethral Resection of the Prostate'],[],[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0278106', 'cui_str': 'Anejaculation'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]",[],,0.247962,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001100.01']
480,32401625,The Effect of Home Base Physical Activity Program based on the BASNEF Model on Motor Recovery in Patients with Stroke.,"The present study aimed to determine the effect of education based on the BASNEF model on the physical activity and improvement of motor activity in patients with stroke. This randomized control trial study was conducted on 40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018. The patients were randomly divided into intervention and control groups. The intervention included personal education and a manual CD of physical activity for the intervention group. After education, the mean scores of the BASNEF model's constructs in the intervention group were significantly higher than those of the control group ( P  < .001). Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001). Interventions based on educational models can increase the motivation of patients with stroke in performing recommended physical activity.",2020,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001).","['Patients with Stroke', '40 patients with acute ischemic stroke admitted to a teaching hospital in Isfahan, Iran from August 2017 to September 2018', 'patients with stroke']",['Home Base Physical Activity Program'],"['motor ability', ""mean scores of the BASNEF model's constructs"", 'upper and lower extremities', 'motor activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",40.0,0.0142828,"Furthermore, the motor ability of the intervention group in upper and lower extremities was significantly higher than that of the control group ( p  < .001).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Esteki-Ghashghaei', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Saadatnia', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Hospital, Isfahan University of Medical Sciences , Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahnazi', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences , Isfahan, Iran.'}]",Home health care services quarterly,['10.1080/01621424.2020.1765938']
481,32200759,Derivation and Application of a Tool to Estimate Benefits From Multiple Therapies That Reduce Recurrent Stroke Risk.,"Background and Purpose- Lowering blood pressure and cholesterol, antiplatelet/antithrombotic use, and smoking cessation reduce risk of recurrent stroke. However, gaps in risk factor control among stroke survivors warrant development and evaluation of alternative care delivery models that aim to simultaneously improve multiple risk factors. Randomized trials of care delivery models are rarely of sufficient duration or size to be powered for low-frequency outcomes such as observed recurrent stroke. This creates a need for tools to estimate how changes across multiple stroke risk factors reduce risk of recurrent stroke. Methods- We reviewed existing evidence of the efficacy of interventions addressing blood pressure reduction, cholesterol lowering, antiplatelet/antithrombotic use, and smoking cessation and extracted relative risks for each intervention. From this, we developed a tool to estimate reductions in recurrent stroke risk, using bootstrapping and simulation methods. We also calculated a modified Global Outcome Score representing the proportion of potential benefit (relative risk reduction) achieved if all 4 individual risk factors were optimally controlled. We applied the tool to estimate stroke risk reduction among 275 participants with complete 12-month follow-up data from a recently published randomized trial of a healthcare delivery model that targeted multiple stroke risk factors. Results- The recurrent stroke risk tool was feasible to apply, yielding an estimated reduction in the relative risk of ischemic stroke of 0.36 in both the experimental and usual care trial arms. Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors. Conclusions- A stroke risk reduction tool facilitates estimation of the combined impact on vascular risk of improvements in multiple stroke risk factors and provides a summary outcome for studies testing alternative care models to prevent recurrent stroke. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00861081.",2020,"Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors.",['275 participants with complete 12-month follow-up data from a recently published randomized trial of a healthcare delivery model that targeted multiple stroke risk factors'],"['Conclusions', ' and Purpose', 'Methods']","['Lowering blood pressure and cholesterol, antiplatelet/antithrombotic use, and smoking cessation reduce risk of recurrent stroke', 'Recurrent Stroke Risk']","[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0011211', 'cui_str': 'Delivery of Healthcare'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}]",275.0,0.076074,"Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors.","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Jackson', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Bryg', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, CA (R.J.B., A.B.).'}, {'ForeName': 'Arleen', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA (A.T.).'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'Keck School of Medicine of USC, Los Angeles, CA (N.S.).'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'From the UCLA David Geffen School of Medicine, Los Angeles, CA (A.R., N.J.J., E.M.C., A.B., F.B., N.L.).'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY (B.G.V.).'}]",Stroke,['10.1161/STROKEAHA.119.027160']
482,31715173,Effect of individualized feedback on learning curves in EGD and colonoscopy: a cluster randomized controlled trial.,"BACKGROUND AND AIMS


Gastroenterology fellowships need to ensure that trainees achieve competence in upper endoscopy (EGD) and colonoscopy. Because the impact of structured feedback remains unknown in endoscopy training, this study compared the effect of structured feedback with standard feedback on trainee learning curves for EGD and colonoscopy.
METHODS


In this multicenter, cluster, randomized controlled trial, trainees received either individualized quarterly learning curves or feedback standard to their fellowship. Assessment was performed in all trainees using the Assessment of Competency in Endoscopy tool on 5 consecutive procedures after every 25 EGDs and colonoscopies. Individual learning curves were created using cumulative sum (CUSUM) analysis. The primary outcome was the mean CUSUM score in overall technical and overall cognitive skills.
RESULTS


In all, 13 programs including 132 trainees participated. The intervention arm (6 programs, 51 trainees) contributed 558 EGD and 600 colonoscopy assessments. The control arm (7 programs, 81 trainees) provided 305 EGD and 468 colonoscopy assessments. For EGD, the intervention arm (-.7 [standard deviation {SD}, 1.3]) had a superior mean CUSUM score in overall cognitive skills compared with the control arm (1.6 [SD, .8], P = .03) but not in overall technical skills (intervention, -.26 [SD, 1.4]; control, 1.76 [SD, .7]; P = .06). For colonoscopy, no differences were found between the 2 arms in overall cognitive skills (intervention, -.7 [SD, 1.3]; control, .7 [SD, 1.3]; P = .95) or overall technical skills (intervention, .1 [SD, 1.5]; control, -.1 [SD, 1.5]; P = .77).
CONCLUSIONS


Quarterly feedback in the form of individualized learning curves did not affect learning curves for EGD and colonoscopy in a clinically meaningful manner. (Clinical trial registration number: NCT02891304.).",2020,Quarterly feedback in the form of individualized learning curves did not affect learning curves for EGD and colonoscopy in a clinically meaningful manner.,['132 trainees participated'],['individualized quarterly learning curves or feedback standard to their fellowship'],"['mean CUSUM score in overall technical and overall cognitive skills', 'overall technical skills', 'overall cognitive skills', 'superior mean CUSUM score in overall cognitive skills']",[],"[{'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",600.0,0.160941,Quarterly feedback in the form of individualized learning curves did not affect learning curves for EGD and colonoscopy in a clinically meaningful manner.,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Obuch', 'Affiliation': 'Division of Gastroenterology, Geisenger Medical Center, Danville, Pennsylvania, USA.'}, {'ForeName': 'Rajesh N', 'Initials': 'RN', 'LastName': 'Keswani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""Children's Hospital Association, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Swati G', 'Initials': 'SG', 'LastName': 'Patel', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Menard-Katcher', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}, {'ForeName': 'Violette', 'Initials': 'V', 'LastName': 'Simon', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}, {'ForeName': 'Eze', 'Initials': 'E', 'LastName': 'Ezekwe', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Aagaard', 'Affiliation': 'Washington University School of Medicine in St. Louis, St Louis, Missouri, USA.'}, {'ForeName': 'Asyia', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'Division of Gastroenterology and Hepatology, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alghamdi', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Austin', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Wisconsin School of Medicine, Madison, Wisconsin, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Brimhall', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Broy', 'Affiliation': 'Division of Gastroenterology, Advocate Lutheran General Hospital, Park Ridge, Illinois, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Carlin', 'Affiliation': 'Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz Medical Center, Aurora, Colorado.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cooley', 'Affiliation': 'Division of Gastroenterology, Ascension Providence Hospital, Southfield, Michigan, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Di Palma', 'Affiliation': 'Division of Gastroenterology, University of South Alabama, Mobile, Alabama, USA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Duloy', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}, {'ForeName': 'Dayna S', 'Initials': 'DS', 'LastName': 'Early', 'Affiliation': 'Division of Gastroenterology, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Swan', 'Initials': 'S', 'LastName': 'Ellert', 'Affiliation': 'Colorado Clinical and Translational Sciences Institute, University of Colorado Anschutz Medical Center, Aurora, Colorado.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Gaumnitz', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Wisconsin School of Medicine, Madison, Wisconsin, USA.'}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Goyal', 'Affiliation': 'Division of Gastroenterology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kathpalia', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Lukejohn', 'Initials': 'L', 'LastName': 'Day', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Najwa', 'Initials': 'N', 'LastName': 'El-Nachef', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerman', 'Affiliation': 'Division of Gastroenterology, University of Miami, Miami, Florida, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Lunsford', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, USA.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Mittal', 'Affiliation': 'Division of Gastroenterology, University of California, Irvine, Irvine, California, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Morigeau', 'Affiliation': 'Division of Gastroenterology, University of Texas Health San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Pietrak', 'Affiliation': 'Division of Gastroenterology and Hepatology, Drexel University College of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Piper', 'Affiliation': 'Division of Gastroenterology, Ascension Providence Hospital, Southfield, Michigan, USA.'}, {'ForeName': 'Anand S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Shapiro', 'Affiliation': 'Division of Gastroenterology, Advocate Lutheran General Hospital, Park Ridge, Illinois, USA.'}, {'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Shergill', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sonnier', 'Affiliation': 'Division of Gastroenterology, University of South Alabama, Mobile, Alabama, USA.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Sorrell', 'Affiliation': 'Division of Gastroenterology, University of Texas Health San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Shivakumar', 'Initials': 'S', 'LastName': 'Vignesh', 'Affiliation': 'Division of Gastroenterology and Hepatology, SUNY Downstate Medical Center, Brooklyn, New York, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Wani', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Center, Aurora, Colorado, USA.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.10.032']
483,30688558,Analgesic Effect of a Single Drop of Nepafenac 0.3% on Pain Associated with Intravitreal Injections: A Randomized Clinical Trial.,"PURPOSE


To evaluate the analgesic effect of nepafenac 0.3% in patients undergoing intravitreal injections (IVI) of antivascular endothelial growth factors.
METHODS


This is a single-center, prospective, randomized, blinded, triple-arm, placebo-controlled interventional study. Patients were randomized into 3 Groups. Group 1 (n = 33) received nepafenac 0.1%, Group 2 (n = 32) received nepafenac 0.3%, and Group 3 (n = 31) received placebo 40 min before IVI. Using the short form of the McGill Pain Questionnaire (SF-MPQ), pain intensity was assessed with the visual analog scale (VAS), the Main Component of the SF-MPQ, and the present pain intensity (PPI) scores immediately and 6 h postinjection.
RESULTS


Immediately after IVI, the VAS pain score was statistically significantly lower in patients treated with nepafenac 0.1% and 0.3%, compared with placebo (P < 0.001 and P = 0.001, respectively). The PPI scores were statistically significantly lower when nepafenac 0.1% or 0.3% was instilled compared with placebo (P = 0.01 and P < 0.0001, respectively). The Main Component of the SF-MPQ scores were statistically significantly lower after nepafenac 0.1% and 0.3% administration compared with placebo (P = 0.001 and P < 0.001, respectively). Six hours post-IVI the nepafenac 0.3% demonstrated statistically significantly higher analgesic effect compared with nepafenac 0.1% and placebo as this was indicated by the VAS pain score (P = 0.013 and P < 0.00001, respectively) and by the PPI score (P = 0.01 and P < 0.00001, respectively).
CONCLUSIONS


A single instillation of nepafenac 0.1% or 0.3% before IVI could effectively alleviate the IVI-related pain. The 0.3% formula exerts its analgesic effect more intensively at 6 h after the IVI.",2019,"The Main Component of the SF-MPQ scores were statistically significantly lower after nepafenac 0.1% and 0.3% administration compared with placebo (P = 0.001 and P < 0.001, respectively).",['patients undergoing intravitreal injections (IVI) of antivascular endothelial growth factors'],"['nepafenac', 'Intravitreal Injections', 'Nepafenac', 'placebo']","['Pain', 'PPI score', 'pain intensity (PPI) scores', 'visual analog scale (VAS', 'analgesic effect', 'effectively alleviate the IVI-related pain', 'SF-MPQ scores', 'McGill Pain Questionnaire (SF-MPQ), pain intensity', 'VAS pain score', 'PPI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0079280', 'cui_str': 'ECDGF'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0024985', 'cui_str': 'McGill Pain Questionnaire'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.185984,"The Main Component of the SF-MPQ scores were statistically significantly lower after nepafenac 0.1% and 0.3% administration compared with placebo (P = 0.001 and P < 0.001, respectively).","[{'ForeName': 'Constantine D', 'Initials': 'CD', 'LastName': 'Georgakopoulos', 'Affiliation': 'Department of Ophthalmology, Medical School, University of Patras, Patras, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Plotas', 'Affiliation': 'Department of Ophthalmology, Medical School, University of Patras, Patras, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Kagkelaris', 'Affiliation': 'Department of Ophthalmology, Medical School, University of Patras, Patras, Greece.'}, {'ForeName': 'Foteini', 'Initials': 'F', 'LastName': 'Tsapardoni', 'Affiliation': 'Department of Ophthalmology, Medical School, University of Patras, Patras, Greece.'}, {'ForeName': 'Olga E', 'Initials': 'OE', 'LastName': 'Makri', 'Affiliation': 'Department of Ophthalmology, Medical School, University of Patras, Patras, Greece.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2018.0113']
484,32107817,Effectiveness of WhatsApp online group discussion for smoking relapse prevention: protocol for a pragmatic randomized controlled trial.,"BACKGROUND AND AIMS


Sustained psychosocial support via online social groups may help former tobacco users maintain abstinence. This study aims to examine the effectiveness of participating in a WhatsApp social group for long-term smoking cessation.
DESIGN


Two-arm, open-labelled, pragmatic, individually randomized controlled trial.
SETTING


All participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones.
PARTICIPANTS


Participants included 1008 adult quitters who self-report no tobacco use in the past 3-30 days.
INTERVENTIONS


The intervention group (n = 504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones. All social groups will be led by counselors or specialist nurse practitioners. The control group (n = 504) will receive similar reminders via short messages to their own mobile phones but will not interact with other participants. The intervention duration for both groups is 8 weeks. Both groups will receive a booklet at baseline about how to prevent smoking relapse.
MEASUREMENTS


The primary outcome is biochemically validated tobacco abstinence at 12 months after consent.
COMMENTS


The findings will provide evidence concerning the utility of operating online social group discussion for prevention of smoking relapse and sustaining long-term abstinence.",2020,"The control group (n=504) will receive similar reminders via short messages to their own mobile phones, but will not interact with other participants.","['All participants are service users of smoking cessation clinics, and all interventions are delivered via mobile phones', '1,008 adult quitters who self-report no tobacco use in the past 3 to 30 days']","['WhatsApp online group discussion', 'intervention group (n=504) will join a WhatsApp social group to receive standardized and theory-based reminders of smoking relapse prevention and participate in discussion with other WhatsApp group members using their own mobile phones', 'similar reminders via short messages to their own mobile phones']",['tobacco abstinence'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0687744', 'cui_str': 'Social group (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}]",1008.0,0.146403,"The control group (n=504) will receive similar reminders via short messages to their own mobile phones, but will not interact with other participants.","[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ching Han Helen', 'Initials': 'CHH', 'LastName': 'Chan', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Kin Sang', 'Initials': 'KS', 'LastName': 'Ho', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Wai-Yin Patrick', 'Initials': 'WP', 'LastName': 'Fok', 'Affiliation': 'Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals, Hong Kong.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Conway', 'Affiliation': 'Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'William Ho Cheung', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, the University of Hong Kong, Hong Kong.'}]","Addiction (Abingdon, England)",['10.1111/add.15027']
485,32167568,Effect of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Impulse Inhibition in Abstinent Patients With Methamphetamine Addiction: A Randomized Clinical Trial.,"Importance


Impulsivity during periods of abstinence is a critical symptom of patients who use methamphetamine (MA).
Objective


To evaluate changes in impulse inhibition elicited by repetitive transcranial magnetic stimulation (rTMS) in patients with MA addiction.
Design, Setting, and Participants


This randomized clinical trial was conducted in Da Lian Shan Addiction Rehabilitation Center, Nanjing, China, from December 1, 2018, to April 20, 2019. Effects of the intervention were examined at 3 time points: after a single session (day 1), 24 hours after 10 repeated sessions (day 11), and at 3 weeks of follow-up (day 31). Men with MA addiction and healthy male control participants were recruited for this study. Data analysis was performed from March 2019 to October 2019.
Interventions


Patients who use MA were randomized to undergo sham rTMS (36 patients) and or 1-Hz rTMS (37 patients) to the left prefrontal cortex, receiving daily TMS treatments for 10 consecutive days.
Main Outcomes and Measures


The primary outcome was impulse inhibition, which is primarily embodied by accuracy reduction (ie, accuracy cost) from standard to deviant trials in a 2-choice oddball task (80% standard and 20% deviant trials).
Result


The study included 73 men with MA addiction (mean [SD] age, 38.49 [7.69] years) and 33 male healthy control participants without MA addiction (mean [SD] age, 35.15 [9.68] years). The mean (SD) duration of abstinence for the men with MA addiction was 9.27 (4.61) months. Compared with the control group, patients with MA addiction exhibited greater impulsivity (accuracy cost, 3.3% vs 6.2%). The single session of 1-Hz rTMS over the left prefrontal cortex significantly increased accuracy from 91.4% to 95.7% (F1,36 = 9.58; P < .001) and reaction time delay from 50 milliseconds to 77 milliseconds (F1,36 = 22.66; P < .001) in deviant trials. These effects were seen consistently after 10 sessions of 1-Hz rTMS treatment (day 11 vs day 1, t26 = 1.59; P = .12), and the behavioral improvement was maintained at least for 3 weeks after treatment (day 31 vs day 1, t26 = 0.26; P = .80). These improvement effects of impulse inhibition were coupled with a reduction in addictive symptoms as measured by cue-induced craving. The pretest accuracy cost was positively correlated with the change in impulse inhibition (r = 0.615; P < .001) and change in craving (r = 0.334; P = .01), suggesting that these 2 behaviors may be modified simultaneously.
Conclusions and Relevance


These findings suggest that repeated rTMS sessions have sustained effects on impulse inhibition in patients with MA addiction and provide novel data on impulsivity management strategies for addiction rehabilitation.
Trial Registration


ChiCTR-ROC-16008541.",2020,These improvement effects of impulse inhibition were coupled with a reduction in addictive symptoms as measured by cue-induced craving.,"['patients who use methamphetamine (MA', 'Da Lian Shan Addiction Rehabilitation Center, Nanjing, China, from December 1, 2018, to April 20, 2019', '73 men with MA addiction (mean [SD] age, 38.49 [7.69] years) and 33 male healthy control participants without MA addiction (mean [SD] age, 35.15 [9.68] years', 'Abstinent Patients With Methamphetamine Addiction', 'Men with MA addiction and healthy male control participants', 'patients with MA addiction', 'Interventions\n\n\nPatients who use MA']","['sham rTMS', 'rTMS sessions', 'repetitive transcranial magnetic stimulation (rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation', '1-Hz rTMS (37 patients) to the left prefrontal cortex, receiving daily TMS treatments']","['pretest accuracy cost', 'Impulse Inhibition', 'impulsivity (accuracy cost', 'impulse inhibition, which is primarily embodied by accuracy reduction (ie, accuracy cost) from standard to deviant trials in a 2-choice oddball task', 'mean (SD) duration of abstinence', 'change in craving', 'reaction time delay', 'behavioral improvement', 'addictive symptoms', 'impulse inhibition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",73.0,0.0992679,These improvement effects of impulse inhibition were coupled with a reduction in addictive symptoms as measured by cue-induced craving.,"[{'ForeName': 'Jiajin', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Institute of Brain and Psychological Sciences, Sichuan Normal University, Chengdu, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Qiongdan', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, China.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Da Lian Shan Institute of Addiction Rehabilitation, Nanjing, China.'}, {'ForeName': 'Molly V', 'Initials': 'MV', 'LastName': 'Lucas', 'Affiliation': 'Wu Tsai Neurosciences Institute, Stanford University, Stanford, California.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0910']
486,32154888,Effects of In-Person Assistance vs Personalized Written Resources About Social Services on Household Social Risks and Child and Caregiver Health: A Randomized Clinical Trial.,"Importance


Social and economic contexts shape children's short- and long-term health. Efforts to address contextual risk factors are increasingly incorporated into pediatric health care.
Objective


To compare the effectiveness of 2 social risk-related interventions.
Design, Setting, and Participants


This randomized clinical trial included English- and/or Spanish-speaking caregiver-child dyads recruited from a pediatric urgent care clinic nested in a large, urban, safety-net hospital. Study recruitment, enrollment, and follow-up were conducted from July 18, 2016, to March 8, 2019. Data analysis was conducted from January 1, 2019, to January 20, 2020.
Interventions


Following standardized social risk assessment, caregivers were randomly assigned to receive either written information regarding relevant government and community social services resources or comparable written information plus in-person assistance and follow-up focused on service access.
Main Outcomes and Measures


Caregiver-reported number of social risk factors and child health 6 months after enrollment.
Results


Among 611 caregiver-child dyads enrolled in the study, 302 dyads were randomized to the written resources group and 309 dyads were randomized to the written resources plus in-person assistance group. The mean (SD) age of children was 6.1 (5.0) years; 483 children (79.1%) were Hispanic; and 315 children (51.6%) were girls. There were no significant differences between groups in the effects of the interventions. In post hoc secondary analyses, the number of reported social risks decreased from baseline to 6-month follow-up in both groups: caregivers who received written resources alone reported a mean (SE) of 1.28 (0.19) fewer risks at follow-up, while those receiving written resources plus in-person assistance reported 1.74 (0.21) fewer risks at follow-up (both P < .001). In both groups, there were small but statistically significant improvements from baseline to follow-up in child health (mean [SE] change: written resources, 0.37 [0.07]; written resources plus in-person assistance, 0.24 [0.07]; both P < .001).
Conclusions and Relevance


This randomized clinical trial compared 2 approaches to addressing social risks in a pediatric urgent care setting and found no statistically significant differences in the social risk and child and caregiver health effects of providing written resources at the point of care with vs without in-person longitudinal navigation services. Caregivers in both groups reported fewer social risks and improved child and caregiver health 6 months after the intervention. These findings deepen understanding of effective doses of social risk-related interventions.
Trial Registration


ClinicalTrials.gov Identifier: NCT02746393.",2020,"In post hoc secondary analyses, the number of reported social risks decreased from baseline to 6-month follow-up in both groups: caregivers who received written resources alone reported a mean (SE) of 1.28 (0.19) fewer risks at follow-up, while those receiving written resources plus in-person assistance reported 1.74 (0.21) fewer risks at follow-up (both P < .001).","['The mean (SD) age of children was 6.1 (5.0) years; 483 children (79.1%) were Hispanic; and 315 children (51.6%) were girls', '611 caregiver-child dyads enrolled in the study, 302 dyads were randomized to the written resources group and 309 dyads', 'Data analysis was conducted from January 1, 2019, to January 20, 2020', 'English- and/or Spanish-speaking caregiver-child dyads recruited from a pediatric urgent care clinic nested in a large, urban, safety-net hospital']","['written information regarding relevant government and community social services resources or comparable written information plus in-person assistance and follow-up focused on service access', 'written resources plus in-person assistance group', '2 social risk-related interventions']","['Household Social Risks and Child and Caregiver Health', 'number of reported social risks', 'social risks and improved child and caregiver health', 'Measures\n\n\nCaregiver-reported number of social risk factors and child health 6 months after enrollment', 'child health']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1551285', 'cui_str': 'Urgent Care Clinics'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3661443', 'cui_str': 'Safety-net Hospitals'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",302.0,0.0759744,"In post hoc secondary analyses, the number of reported social risks decreased from baseline to 6-month follow-up in both groups: caregivers who received written resources alone reported a mean (SE) of 1.28 (0.19) fewer risks at follow-up, while those receiving written resources plus in-person assistance reported 1.74 (0.21) fewer risks at follow-up (both P < .001).","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Gottlieb', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wing', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Velazquez', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Keeton', 'Affiliation': 'School of Nursing, Department of Family Health Care Nursing, University of California, San Francisco.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Maricarmen', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Munoz Vera', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Urrutia Caceres', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arevalo', 'Affiliation': 'Department of Urology, University of California, San Francisco.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Herrera', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Bernal Suarez', 'Affiliation': 'Social Interventions Research and Evaluation Network, Department of Family and Community Medicine, University of California, San Francisco.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'Department of Family and Community Medicine, University of California, San Francisco.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0701']
487,32183608,Effects of an Iodine-Containing Prenatal Multiple Micronutrient on Maternal and Infant Iodine Status and Thyroid Function: A Randomized Trial in The Gambia.,"Background:  Iodine supplementation is recommended to pregnant women in iodine-deficient populations, but the impact in moderate iodine deficiency is uncertain. We assessed the effect of an iodine-containing prenatal multiple micronutrient (MMN) supplement in a rural Gambian population at risk of moderate iodine deficiency.  Materials and Methods:  This study uses data and samples collected as a part of the randomized controlled trial Early Nutrition and Immune Development (ENID; ISRCTN49285450) conducted in Keneba, The Gambia. Pregnant women (<20 weeks gestation) were randomized to either a daily supplement of MMNs containing 300 μg of iodine or an iron and folic acid (FeFol) supplement. Randomization was double blinded (participants and investigators). The coprimary outcomes were maternal urinary iodine concentration (UIC) and serum thyroglobulin (Tg), assessed at baseline and at 30 weeks' gestation. Secondary outcomes were maternal serum thyrotropin (TSH), total triiodothyronine (TT3), total thyroxine (TT4) (assessed at baseline and at 30 weeks' gestation), breast milk iodine concentration (BMIC) (assessed at 8, 12, and 24 weeks postpartum), infant serum Tg (assessed at birth [cord], 12, and 24 weeks postpartum), and serum TSH (assessed at birth [cord]). The effect of supplementation was evaluated using mixed effects models.  Results:  A total of 875 pregnant women were enrolled between April 2010 and February 2015. In this secondary analysis, we included women from the MMN ( n  = 219) and FeFol ( n  = 219) arm of the ENID trial. At baseline, median (interquartile range or IQR) maternal UIC and Tg was 51 μg/L (33-82) and 22 μg/L (12-39), respectively, indicating moderate iodine deficiency. Maternal MMN supplement increased maternal UIC ( p  < 0.001), decreased maternal Tg ( p  < 0.001), and cord blood Tg ( p  < 0.001) compared with FeFol. Maternal thyroid function tests (TSH, TT3, TT4, and TT3/TT4 ratio) and BMIC did not differ according to maternal supplement group over the course of the study. Median (IQR) BMIC, maternal UIC, and infant Tg in the MMN group were 51 μg/L (35-72), 39 μg/L (25-64), and 87 μg/L (59-127), respectively, at 12 weeks postpartum, and did not differ between supplement groups.  Conclusions:  Supplementing moderately iodine-deficient women during pregnancy improved maternal iodine status and reduced Tg concentration. However, the effects were not attained postpartum and maternal and infant iodine nutrition remained inadequate during the first six months after birth. Consideration should be given to ensuring adequate maternal status through pregnancy and lactation in populations with moderate deficiency.",2020,"Maternal MMN supplement increased maternal UIC (p<0·001), decreased maternal Tg (p<0·001) and cord blood Tg (p<0.001) compared with FeFol.","['women from the MMN (n=219) and FeFol (n=219) arm of the ENID trial', 'Pregnant women (<20 weeks gestation', '875 pregnant women were enrolled between April 2010 and February 2015', 'rural Gambian population at risk of moderate iodine deficiency', 'pregnant women in iodine deficient populations']","['daily supplement of multiple micronutrients (MMN) containing 300 µg of iodine, or an iron-folic acid (FeFol) supplement', 'iodine-containing prenatal multiple micronutrient', 'iodine containing prenatal multiple micronutrient supplement', 'Iodine supplementation']","['Maternal thyroid function tests (TSH, TT3, TT4, and TT3/TT4 ratio) and BMIC', 'maternal UIC (p<0·001), decreased maternal Tg (p<0·001) and cord blood Tg', 'maternal and infant iodine status and thyroid function', ""maternal urinary iodine concentration (UIC) and serum thyroglobulin (Tg), assessed at baseline and 30 weeks' gestation"", ""maternal serum thyroid stimulating hormone (TSH), total triiodothyronine (TT3), total thyroxine (TT4) (assessed at baseline and 30 weeks' gestation), breast milk iodine concentration (BMIC) (assessed at 8, 12 and 24 weeks postpartum), infant serum Tg (assessed at birth (cord), 12 and 24 weeks postpartum) and serum TSH (assessed at birth (cord"", 'maternal iodine status and reduced Tg concentration']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517897', 'cui_str': '875'}, {'cui': 'C0337833', 'cui_str': 'Gambians (ethnic group)'}, {'cui': 'C0242444', 'cui_str': 'Population at Risk'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0342199', 'cui_str': 'Iodine deficiency syndrome (disorder)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0337445', 'cui_str': 'Thyroglobulin measurement (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",875.0,0.156679,"Maternal MMN supplement increased maternal UIC (p<0·001), decreased maternal Tg (p<0·001) and cord blood Tg (p<0.001) compared with FeFol.","[{'ForeName': 'Kamilla G', 'Initials': 'KG', 'LastName': 'Eriksen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Andersson', 'Affiliation': ""Division of Gastroenterology and Nutrition, Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hunziker', 'Affiliation': 'Human Nutrition Laboratory, Institute of Food, Nutrition, and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Human Nutrition Laboratory, Institute of Food, Nutrition, and Health, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Moore', 'Affiliation': ""Department of Women and Children's Health, King's College London, London, United Kingdom.""}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0789']
488,32065827,Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial.,"Importance


Intraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.
Objective


To test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.
Design, Setting, and Participants


Preliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.
Interventions


Patients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.
Main Outcomes and Measures


The primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).
Results


Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
Conclusions and Relevance


In this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT03376347.",2020,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","['adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019', 'During Elective Noncardiac Surgery', '68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women', 'patients undergoing elective noncardiac surgery']","['early warning system (n\u2009=\u200934) or standard care', 'Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care', 'machine learning-derived early warning system compared with standard care']","['median time of hypotension', 'mean arterial pressure (MAP', 'intraoperative hypotension', 'time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury', 'median length of surgery', 'Hypotension', 'median time-weighted average of hypotension', '0 serious adverse events resulting in death', 'morbidity and mortality', 'Depth and Duration of Intraoperative Hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1270999', 'cui_str': 'Invasive blood pressure (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517362', 'cui_str': 'Hypotension during surgery (disorder)'}, {'cui': 'C1519795', 'cui_str': 'Unit of measure (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",68.0,0.308548,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Wijnberge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Hol', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Lemmers', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Marijn P', 'Initials': 'MP', 'LastName': 'Mulder', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schenk', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Lotte E', 'Initials': 'LE', 'LastName': 'Terwindt', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2020.0592']
489,32023661,"Full-mouth disinfection effects on gingival fluid calprotectin, osteocalcin, and N-telopeptide of Type I collagen in severe periodontitis.","BACKGROUND


To compare the effects of full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD) on clinical, microbiological and biochemical parameters with conventional quadrant-wise scaling and root planning (Q-SRP) in severe chronic periodontitis.
METHODS


In the present prospective randomized controlled clinical trial with three parallel arms (#NCT04038801), 60 chronic periodontitis patients were randomly assigned to three study groups by a consecutive number in ascending order: FMD (n = 20), FMUD (n = 20), and Q-SRP (n = 20). All measurements and treatments were performed by the same investigator. At baseline, gingival crevicular fluid (GCF) and subgingival plaque were collected and clinical periodontal parameters were recorded. Ultrasonic debridement was completed within 24 hours in FMD and FMUD groups. Chlorhexidine gluconate was used for FMD. Q-SRP was performed by hand instruments per quadrant at 1-week-intervals. Clinical measurements and sampling were repeated at 1, 3, and 6 months after treatment. Real-time PCR was used for quantitative analysis of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia, Fusobacterium nucleatum, and total bacteria count. GCF Calprotectin, osteocalcin, and N-telopeptide of type I collagen (NTx) levels were analyzed by ELISA. The changes of GCF biomarker levels after treatment between groups were the primary outcomes.
RESULTS


No harm was observed. All treatment strategies resulted in significant improvements in all clinical parameters (P < 0.05), with no significant differences between study groups at all time-points (P ˃ 0.05). Aggregatibacter actinomycetemcomitans was significantly decreased in FMD compared to FMUD and Q-SRP at 6 months (P < 0.05). Although GCF NTx total amounts increased in all groups during the study period, this increase was less prominent in full-mouth groups at three time points after treatment (P < 0.05).
CONCLUSIONS


Present results represent the short-term effects. Full-mouth treatment approaches offered limited beneficial effects on microbiological and biochemical parameters over quadrant-wise approach. All three treatment strategies can be recommended in the management of severe chronic periodontitis.",2020,"All treatment strategies resulted in significant improvements in all clinical parameters (p<0.05), with no significant differences between study groups at all time-points (p˃0.05).","['60 chronic periodontitis patients', 'severe chronic periodontitis']","['Chlorhexidine gluconate', 'full-mouth disinfection', 'full-mouth disinfection (FMD) and full-mouth ultrasonic debridement (FMUD', 'Ultrasonic debridement', 'FMUD', 'conventional quadrant-wise scaling and root planning (Q-SRP']","['GCF biomarker levels', 'gingival crevicular fluid (GCF) and subgingival plaque', 'GCF Calprotectin, osteocalcin and N-telopeptide of type', 'I collagen (NTx) levels', 'GCF NTx total amounts', 'Aggregatibacter actinomycetemcomitans', 'gingival crevicular fluid levels of calprotectin, osteocalcin and N-telopeptide of type I collagen']","[{'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque (disorder)'}, {'cui': 'C0950624', 'cui_str': 'Calgranulin'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0085488', 'cui_str': 'Haemophilus actinomycetemcomitans'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]",60.0,0.0757924,"All treatment strategies resulted in significant improvements in all clinical parameters (p<0.05), with no significant differences between study groups at all time-points (p˃0.05).","[{'ForeName': 'Beral', 'Initials': 'B', 'LastName': 'Afacan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Adnan Menderes University, Aydın, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Çınarcık', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Gürkan', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Güven', 'Initials': 'G', 'LastName': 'Özdemir', 'Affiliation': 'Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Izmir, Turkey.'}, {'ForeName': 'Harika Atmaca', 'Initials': 'HA', 'LastName': 'İlhan', 'Affiliation': 'Department of Biology, Section of Molecular Biology, Faculty of Science and Letters, Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Caner', 'Initials': 'C', 'LastName': 'Vural', 'Affiliation': 'Department of Biology, Basic and Industrial Microbiology Section, Faculty of Science, Ege University, Izmir, Turkey.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Köse', 'Affiliation': 'Department of Biostatistics and Medical Informatics, Faculty of Medicine, Ege University, Izmir, Turkey.'}, {'ForeName': 'Gülnur', 'Initials': 'G', 'LastName': 'Emingil', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Ege University, İzmir, Turkey.'}]",Journal of periodontology,['10.1002/JPER.19-0445']
490,32175587,Human Papilloma Virus Vaccination Compliance in a Military Aviation Training Community.,"INTRODUCTION


Human Papilloma Virus (HPV) vaccination compliance as reported by the CDC in 2011 falls short of a national goal to have 80% of adolescents vaccine-complete by 2020. The Naval Aviation Schools Command, Pensacola, Florida offers a single point of contact for military aviation trainees offering near-complete capture of an HPV vaccine target population. The purpose of this study is to identify baseline HPV vaccination rates among military aviation trainees and whether or not the provision of educational materials at the start of aviation training would increase future HPV vaccination compliance.
MATERIALS AND METHODS


Approval to conduct this study was obtained from the Institutional Review Board of Naval Medical Center Portsmouth, Virginia. Our population of interest consisted of US Navy and Marine Corps student naval aviators, student naval flight officers (officers), and student enlisted air crew (enlisted) reporting for aviation related duty. A convenience sampling of officer and enlisted student classes checking in for training was performed over a period of 6 months. The first 3 months of students were assigned as the intervention group and the remaining 3 months of students were assigned to the control group. This study was conducted in two parts: (1) an anonymous survey captured cross-sectional data of self-reported HPV vaccine use, and (2) prospective analysis of service members' HPV vaccine rates before and after educational intervention as documented within the military's electronic health record system, Armed Forces Health Longitudinal Technology Application (AHLTA).
RESULTS


AHLTA immunization status was evaluated for 1,164 personnel; 114 (9.8%) were excluded for missing basic vaccination information. Of the remaining 1,050, another 199 (19%) members were excluded as already vaccine complete (evidenced by three shots documented) prior to entry into the study. Within the 199 service members with documented baseline HPV vaccination completion, 197/199 (99%) were officers and 2/199 (0.1%) were enlisted. A total of 851 personnel were included for prospective analysis. Person-time of 100 person years was used and the vaccination rate translates to 16.62/100 person years (95% CI 11.29, 23.59) within intervention vs. 2.96/100 person years (95% CI 0.80, 7.58) within control groups and are significantly different (P = 0.0001). Comparing intervention and control groups, rate ratios = 5.61 (95% CI 2.14, 18.64) and rate differences = 13.66 (95% CI 7.13, 20.19). Among intervention group survey responders who previously reported nonvaccine use, 50.5% reported a change in opinion about obtaining the vaccination, with a higher proportion of enlisted members reporting a change in opinion (62.8% vs. 39.7%, P = 0.0053).
CONCLUSIONS


Electronic health records immunizations review noted a baseline vaccine completion rate of 19%. Our study showed a health inequity between enlisted and officers, with officers having 99% of the documented baseline completion rates per AHLTA data. Our prospective analysis noted statistically significant rate differences of 13.66% and rate ratios of 5.61 between intervention and control groups. This analysis of AHLTA data combined with survey response of 50.5% indicating a change in opinion about HPV vaccine use among those who had not yet started vaccine series suggests targeted education would be a low-cost intervention to improve HPV vaccine use rates.",2020,"Comparing intervention and control groups, rate ratios = 5.61","['military aviation trainees', ""two parts: (1) an anonymous survey captured cross-sectional data of self-reported HPV vaccine use, and (2) prospective analysis of service members' HPV vaccine rates before and after educational intervention as documented within the military's electronic health record system, Armed Forces Health Longitudinal Technology Application (AHLTA"", '199 service members with documented baseline HPV vaccination completion, 197/199 (99%) were officers and 2/199 (0.1%) were enlisted', 'Human Papilloma Virus Vaccination Compliance in a Military Aviation Training Community', 'Of the remaining 1,050, another 199 (19%) members were excluded as already vaccine complete (evidenced by three shots documented) prior to entry into the study', 'A total of 851 personnel']",['aviation training'],"['health inequity', 'baseline HPV vaccination rates', 'rate ratios', 'vaccination rate translates']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0004430', 'cui_str': 'Aviation'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0004430', 'cui_str': 'Aviation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",851.0,0.0734173,"Comparing intervention and control groups, rate ratios = 5.61","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Porter', 'Affiliation': 'Department of Aviation Medicine, Navy Medicine Readiness and Training Unit Jacksonville, Building 964 Enterprise Ave., Jacksonville, FL 32212.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Stoker', 'Affiliation': 'Naval School of Aviation Safety, 181 Chambers Ave, Pensacola, FL 32508.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Seals', 'Affiliation': 'Department of Mathematics and Statistics, University of West Florida, Building 4, 11000 University Parkway, Pensacola, FL 32514.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Drollinger', 'Affiliation': 'Naval Aerospace Medical Institute, 340 Hulse Road, Pensacola, FL 32508.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Schutte', 'Affiliation': 'Dental Department, 23rd Dental Company, PO Box 78830, Twentynine Palms, CA 92278.'}, {'ForeName': 'Jyl W', 'Initials': 'JW', 'LastName': 'Bean', 'Affiliation': 'Department of Aviation Medicine, Navy Medicine Readiness and Training Unit Jacksonville, Building 964 Enterprise Ave., Jacksonville, FL 32212.'}, {'ForeName': 'G Merrill', 'Initials': 'GM', 'LastName': 'Rice', 'Affiliation': 'USS Gerald Ford (CVN 78), FPO AE 09523, VA.'}]",Military medicine,['10.1093/milmed/usaa024']
491,31059177,"Exogenous progesterone for smoking cessation in men and women: a pilot double-blind, placebo-controlled randomized clinical trial.","BACKGROUND AND AIMS


In some clinical studies men and women have been found to differ in their ability to quit smoking, perhaps as a result of progesterone. The primary aim of this study was to provide a preliminary test of whether progesterone (PRO), compared with placebo (PBO), was more effective for smoking cessation in men and women.
DESIGN


Pilot double-blind, placebo-controlled randomized clinical trial.
SETTING


Minneapolis/St Paul metro area, Minnesota, USA.
PARTICIPANTS


A total of 216 participants were randomized, including 113 men (18-60 years; PRO = 56, PBO = 57) and 103 women (18-50 years, pre-menopausal with self-reported regular menstrual cycles; PRO = 51, PBO = 52).
INTERVENTION


Participants were randomized (1 : 1 within sex group) to either PRO (200 mg twice daily) or PBO. Participants were assigned a quit date approximately 7 days after starting medication (luteal phase for women) and were followed for 12 weeks to assess relapse.
MEASUREMENTS


The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at week 4. Secondary outcomes included 7-day PPA at weeks 8 and 12, prolonged abstinence, continuous abstinence, urine cotinine < 50 ng/ml, expired carbon monoxide ≤ 5 parts per million (p.p.m.) and days to relapse.
FINDINGS


There was a significant difference in 7-day PPA at week 4 among women [PRO: 18 (35.3%) versus PBO: 9 (17.3%), odds ratio (OR) = 2.61, 95% confidence interval (CI) = 1.04, 6.54, P = 0.041], but not among men [PRO: 13 (23.2%) versus PBO: 12 (21.1%), 1.13 (0.47, 2.76), P = 0.782]. There was some evidence that PRO delayed relapse in women (days to relapse; PRO: 20.5 ± 29.6 versus PBO: 14.3 ± 26.8, P = 0.03) but not in men (PRO: 13.4 ± 25.9 versus PBO: 13.3 ± 23.8, P = 0.69).
CONCLUSIONS


Oral micronized progesterone may aid smoking cessation in women.",2019,"Secondary outcomes included 7-day PPA at weeks 8 and 12, prolonged abstinence, continuous abstinence, urine cotinine < 50 ng/ml, expired carbon monoxide ≤ 5 parts per million (p.p.m.) and days to relapse.
","['A total of 216 participants were randomized, including 113 men (18-60\xa0years; PRO\xa0=\xa056, PBO\xa0=\xa057) and 103 women (18-50\xa0years, pre-menopausal with self-reported regular menstrual cycles; PRO\xa0=\xa051, PBO\xa0=\xa052', 'Participants were randomized ', 'men and women', 'women']","['Exogenous progesterone', 'placebo', 'micronized progesterone', 'PBO', 'PRO', 'progesterone (PRO', 'placebo (PBO']","['7-day PPA at weeks 8 and 12, prolonged abstinence, continuous abstinence, urine cotinine <\xa050\xa0ng/ml, expired carbon monoxide ≤\xa05\xa0parts per million (p.p.m.) and days to relapse', 'PRO delayed relapse', '7-day PPA', 'self-reported 7-day point prevalence abstinence (PPA']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",216.0,0.607619,"Secondary outcomes included 7-day PPA at weeks 8 and 12, prolonged abstinence, continuous abstinence, urine cotinine < 50 ng/ml, expired carbon monoxide ≤ 5 parts per million (p.p.m.) and days to relapse.
","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Tosun', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Fieberg', 'Affiliation': 'Coordinating Center for Biometric Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Eberly', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Tipp', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Allen', 'Affiliation': 'Department of Family & Community Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Sharon S', 'Initials': 'SS', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14645']
492,32200533,Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia.,"INTRODUCTION


Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (Lotriga ® , Takeda Pharmaceutical Company Limited), are approved in Japan to treat triglyceridemia. We investigated the effects of omega-3 on vascular endothelial function, measured by flow-mediated dilation (FMD).
METHODS


Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting  %FMD in each treatment group. Secondary end points included the 4-h postprandial  %FMD and 4-h postprandial triglyceride (TG) level.
RESULTS


Thirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001). No new safety concerns were identified.
CONCLUSIONS


Fasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT02824432.",2020,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","['Patients With Hyperlipidemia', 'Thirty-seven patients', 'Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors']","['Omega-3 Fatty Acid Ethyl Esters', 'Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation', 'omega-3 at 2\xa0g']","['Mean 4-h postprandial TG level', '4-h postprandial \xa0%FMD and 4-h postprandial triglyceride (TG) level', 'Vascular Endothelial Function', 'Mean 4-h postprandial %FMD', 'change from baseline of fasting \xa0%FMD', 'Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood', '4-h postprandial TG levels', 'Mean fasting %FMD', 'vascular endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0061511', 'cui_str': 'glutaryl-coenzyme A'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}]",37.0,0.0642346,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","[{'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Teramoto', 'Affiliation': 'Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suzaki', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan. yuki.suzaki@takeda.com.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Uemura', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01286-1']
493,32202075,Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus.,"OBJECTIVE


This study aimed to evaluate ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus.
METHODS


Data from three placebo-controlled, randomized, Phase 3 studies were pooled. Patients with baseline BMI ≥ 25 (1,377/1,544; 89%) were assessed with a stratification by BMI subgroup.
RESULTS


At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo. For placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, least squares mean change was 0.1%, -0.8%, and -0.9% for HbA1c and -1.2 kg, -3.1 kg, and -3.2 kg for BW. HbA1c reductions were consistent across BMI subgroups. For ertugliflozin 5 mg and 15 mg, least squares mean change (placebo adjusted) in absolute BW was -1.4 kg and -1.2 kg for BMI 25 to < 30, -1.8 kg and -1.9 kg for BMI 30 to < 35, and -2.5 kg and -2.9 kg for BMI ≥ 35. Percent BW changes were similar across BMI subgroups. Incidence of adverse events was 52.5%, 44.6%, and 50.1% with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively.
CONCLUSIONS


Meaningful reductions in HbA1c, fasting plasma glucose, BW, and SBP were observed with ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Ertugliflozin improved HbA1c and SBP and reduced BW across BMI subgroups. Ertugliflozin was generally well tolerated.",2020,"At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo.","['patients with overweight and obesity with\xa0type 2 diabetes mellitus', 'Patients with Overweight and Obesity with Type 2 Diabetes Mellitus', 'Patients with baseline BMI\u2009≥\u200925 ', 'patients with overweight and obesity with type 2 diabetes mellitus']","['ertugliflozin versus placebo', 'Ertugliflozin', 'ertugliflozin', 'placebo, ertugliflozin', 'placebo, ertugliflozin 5 mg, and ertugliflozin']","['HbA1c reductions', 'Efficacy and Safety', 'tolerated', 'Incidence of adverse events', 'HbA1c, fasting plasma glucose, BW, and SBP', 'HbA1c and SBP and reduced BW', 'glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4535679', 'cui_str': 'ertugliflozin 5 MG'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.0537002,"At week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo.","[{'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Gallo', 'Affiliation': 'Pfizer Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Hakima', 'Initials': 'H', 'LastName': 'Hannachi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, Massachusetts, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22748']
494,31836474,Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT).,"BACKGROUND AND AIMS


Adenoma miss rate during colonoscopy is directly linked to risk of postcolonoscopy colorectal cancer. One of the reasons for missed adenomas is poor visualization of proximal folds during standard colonoscopy withdrawal. Disposable distal attachments such as the plastic cap and Endocuff (Arc Medical Design, Leeds, UK) that hold back folds appear to improve adenoma detection. The primary aim of this study was to compare adenoma detection rates between Endocuff-assisted colonoscopy (EAC) and cap-assisted colonoscopy (CAC).
METHODS


This is a randomized, single-center, tandem colonoscopy trial performed by the same endoscopists on the same day, first with Endocuff Vision (Arc Medical Design, Leeds, UK) followed by cap or vice versa. All procedures were performed by 3 experienced gastroenterology fellows.
RESULTS


One hundred fifty-four patients were recruited. Seventy-eight (50.6%) had CAC as their first procedure. Mean patient age was 61 years (male-to-female ratio, 1:1). Adenoma detection rate was significantly higher for EAC when compared to CAC (53% vs 26%, P = .001). Polyp miss rate was significantly lower in EAC (8.4%) compared with CAC (26.1%, P < .001) as was adenoma miss rate (EAC vs CAC, 6%, vs 19%; P = .002) and diminutive adenoma (<5 mm) miss rate in the EAC group (1.8% vs 19.6%, P < .001). However, there was no significant differences in the miss rates for small adenomas (5-9 mm) (3.7% vs 2.9%, P = .69) or adenomas 10 mm or larger (1.6% vs 2.6%, P = .98 ). The mean number of adenomas per procedure was significantly higher with EAC compared with CAC (1.5 vs .8, P < .001). Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01). Conversely, withdrawal time (median 10 vs 8 minutes, P = .01) was significantly longer in EAC.
CONCLUSIONS


This randomized, tandem study demonstrates that EAC has a significantly higher adenoma detection rate and lower adenoma miss rate than CAC. Although insertion times were shorter with EAC, procedures were slightly more uncomfortable, and the cuff had to be removed in a small number of cases. (Clinical trial registration number: NCT03254498.).",2020,"Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01).","['One hundred fifty-four patients were recruited', 'adenoma detection', 'Mean patient age was 61 years (male-to-female ratio, 1:1']","['Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy', 'EAC', 'Endocuff-assisted colonoscopy (EAC) and cap-assisted colonoscopy (CAC']","['mean number of adenomas per procedure', 'diminutive adenoma', 'Cecal intubation time', 'adenoma detection rate', 'Polyp miss rate', 'adenoma detection rates', 'miss rates for small adenomas', 'Adenoma detection rate', 'adenoma miss rate', 'withdrawal time']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",154.0,0.106835,"Cecal intubation time was significantly shorter with EAC than CAC (median 6 vs 7 minutes, P = .01).","[{'ForeName': 'Rajaratnam', 'Initials': 'R', 'LastName': 'Rameshshanker', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK; Department of Surgery and Cancer, Imperial College, London, UK.""}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Tsiamoulos', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Rajendran', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statconsultancy Ltd, Amersham, UK.'}, {'ForeName': 'Paris', 'Initials': 'P', 'LastName': 'Tekkis', 'Affiliation': 'Department of Surgery and Cancer, Imperial College, London, UK.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Saunders', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital and Academic Institute, Harrow, UK.""}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.046']
495,32492084,Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial.,"Importance


Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed.
Objective


To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19.
Design, Setting, and Participants


Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled.
Intervention


Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity.
Main Outcomes and Measures


Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours.
Results


Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.59 [95% CI, 0.22-1.59]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.95]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care.
Conclusion and Relevance


Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference.
Trial Registration


Chinese Clinical Trial Registry: ChiCTR2000029757.",2020,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","['patients with COVID-19', 'patients with coronavirus disease 2019 (COVID-19', '60 [58.3%] male), 101 (98.1%) completed the trial', '103 of a planned 200 patients were enrolled', '103 patients who were randomized (median age, 70 years', 'Patients With Severe and Life-threatening COVID-19', '103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation', '7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020']","['Convalescent Plasma Therapy', 'convalescent plasma therapy', 'Intervention\n\n\nConvalescent plasma in addition to standard treatment (n\u2009=\u200952) vs standard treatment alone (control']","['Clinical improvement', 'time to clinical improvement', '28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR', '28-day mortality', 'adverse events', 'efficacy and adverse effects', 'time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale', 'negative conversion rate of viral PCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1299454', 'cui_str': 'Patient discharged alive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}]",103.0,0.448056,"Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xunliang', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Respiratory quality control center, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Shangen', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Transfusion, General Hospital of Central Theater Command of PLA, Wuhan, China.'}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Medical Molecular Biology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & Peking Union, Beijing, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Mei', 'Affiliation': 'Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Caiying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Cuihua', 'Initials': 'C', 'LastName': 'Tao', 'Affiliation': 'Department of Blood Transfusion, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Wuhan Blood Center, Wuhan, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Yongpei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Xiaoxiong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Emergency, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Guanggu District Maternal and Child Health Hospital of Hubei Province, Wuhan, China.'}, {'ForeName': 'Nian', 'Initials': 'N', 'LastName': 'Xiong', 'Affiliation': 'Wuhan Red Cross Hospital, Wuhan, China.'}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Wuhan Pulmonary Hospital, Wuhan, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Blood Transfusion, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Man', 'Affiliation': 'Department of Respiratory Medicine, Wuhan Asia General Hospital, Wuhan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Deng', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Chenyue', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Center for Global Health and Infectious Diseases, Comprehensive AIDS Research Center, and Beijing Advanced Innovation Center for Structural Biology, School of Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Systems Biology of Pathogens and Christophe Mérieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanyun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology, University of Miami, Miami, Florida.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Institute of Blood Transfusion, Chinese Academy of Medical Sciences and Peking Union Medical College, Chengdu, China.'}]",JAMA,['10.1001/jama.2020.10044']
496,32186656,Factors Associated With Short-term Relapse in Patients With Pemphigus Who Receive Rituximab as First-line Therapy: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Rituximab and short-term corticosteroid therapy are the criterion standard treatments for patients with newly diagnosed moderate to severe pemphigus.
Objective


To examine factors associated with short-term relapse in patients with pemphigus treated with rituximab.
Design, Setting, and Participants


This post hoc analysis of a randomized clinical trial (Comparison Between Rituximab Treatment and Oral Corticosteroid Treatment in Patients With Pemphigus [RITUX 3]) conducted from January 1, 2010, to December 31, 2015, included patients from 20 dermatology departments of tertiary care centers in France from the RITUX 3 trial and 3 newly diagnosed patients treated according to the trial protocol. Data analysis was performed from February 1 to June 30, 2019.
Exposure


Patients randomly assigned to the rituximab group in the RITUX 3 trial and the 3 additional patients were treated with 1000 mg of intravenous rituximab on days 0 and 14 and 500 mg at months 12 and 18 combined with a short-term prednisone regimen.
Main Outcomes and Measures


Baseline (pretreatment) clinical and biological characteristics (Pemphigus Disease Area Index [PDAI] score, ranging from 0-250 points, with higher values indicating more severe disease) and changes in anti-desmoglein (DSG) 1 and anti-DSG3 values as measured by enzyme-linked immunosorbent assay during the 3 months after rituximab treatment were compared between patients with disease relapse and those who maintained clinical remission during the first 12 months after treatment. The positive and negative predictive values of these factors were calculated.
Results


Among 47 patients (mean [SD] age, 54.3 [17.0] years; 17 [36%] male and 30 [64%] female) included in the study, the mean (SD) baseline PDAI score for patients with relapsing disease was higher than that of the patients with nonrelapsing disease (54 [33] vs 28 [24]; P = .03). At month 3, 7 of 11 patients with relapsing disease (64%) vs 7 of 36 patients with nonrelapsing disease (19%) had persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher (P = .01). A PDAI score of 45 or higher defining severe pemphigus and/or persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher at month 3 provided a positive predictive value of 50% (95% CI, 27%-73%) and a negative predictive value of 94% (95% CI, 73%-100%) for the occurrence of relapse after rituximab.
Conclusions and Relevance


The findings suggest that initial PDAI score and changes in anti-DSG antibody values after the initial cycle of rituximab might help differentiate a subgroup of patients with high risk of relapse who might benefit from maintenance rituximab infusion at month 6 from a subgroup of patients with low risk of relapse who do not need early maintenance therapy.
Trial Registration


NCT00784589.",2020,"At month 3, 7 of 11 patients with relapsing disease (64%) vs 7 of 36 patients with nonrelapsing disease (19%) had persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher (P = .01).","['47 patients (mean [SD] age, 54.3', 'Patients', '17.0] years; 17 [36%] male and 30 [64%] female', 'January 1, 2010, to December 31, 2015, included patients from 20 dermatology departments of tertiary care centers in France from the RITUX 3 trial and 3 newly diagnosed patients treated according to the trial protocol', 'patients with newly diagnosed moderate to severe pemphigus', 'patients with nonrelapsing disease (54 [33] vs 28 [24', 'patients with pemphigus treated with rituximab']","['Rituximab Treatment and Oral Corticosteroid', 'Rituximab as First-line Therapy', 'rituximab', 'Rituximab and short-term corticosteroid therapy', 'intravenous rituximab']","['relapsing disease', 'initial PDAI score and changes in anti-DSG antibody values', 'mean (SD) baseline PDAI score', 'Main Outcomes and Measures\n\n\nBaseline (pretreatment) clinical and biological characteristics', 'persistent anti-DSG1 antibody values', 'severe disease) and changes in anti-desmoglein (DSG) 1 and anti-DSG3 values', 'severe pemphigus and/or persistent anti-DSG1 antibody values']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0587461', 'cui_str': 'Dermatology department (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2599718', 'cui_str': 'Trial Protocols'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0251058', 'cui_str': 'Pemphigus Foliaceus Antigen'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}]",3.0,0.118784,"At month 3, 7 of 11 patients with relapsing disease (64%) vs 7 of 36 patients with nonrelapsing disease (19%) had persistent anti-DSG1 antibody values of 20 IU/mL or higher and/or anti-DSG3 antibody values of 130 IU/mL or higher (P = .01).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mignard', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Department of Dermatology, Rouen University Hospital, Normandie University, INSERM U1234, Rouen, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Maho-Vaillant', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Department of Dermatology, Rouen University Hospital, Normandie University, INSERM U1234, Rouen, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Golinski', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Department of Dermatology, Rouen University Hospital, Normandie University, INSERM U1234, Rouen, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Balayé', 'Affiliation': 'Department of Biostatistics and Clinical Research, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Prost-Squarcioni', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Avicenne Hospital, Assistance Publique-Hôpitaux de Paris, Department of Dermatology, University of Paris 13, Bobigny, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Houivet', 'Affiliation': 'Department of Biostatistics and Clinical Research, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Sé Bastien', 'Initials': 'SB', 'LastName': 'Calbo', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Department of Dermatology, Rouen University Hospital, Normandie University, INSERM U1234, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Labeille', 'Affiliation': 'Department of Dermatology, University of Saint Etienne, Saint Etienne, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Picard-Dahan', 'Affiliation': 'Department of Dermatology, Bichat Hospital, University of Paris X, Paris, France.'}, {'ForeName': 'Maria Polina', 'Initials': 'MP', 'LastName': 'Konstantinou', 'Affiliation': 'Department of Dermatology, University of Toulouse, Toulouse, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Chaby', 'Affiliation': 'Department of Dermatology, University of Amiens, Amiens, France.'}, {'ForeName': 'Marie-Aleth', 'Initials': 'MA', 'LastName': 'Richard', 'Affiliation': 'Assistance Publique des Hôpitaux de Marseille, Department of Dermatology, Aix Marseille University, UMR 911, INSERM CRO2, Marseille, France.'}, {'ForeName': 'Jean-David', 'Initials': 'JD', 'LastName': 'Bouaziz', 'Affiliation': 'Department of Dermatology, St Louis Hospital, Paris 7 Sorbonne Paris Cité University, Paris, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Duvert-Lehembre', 'Affiliation': 'Department of Dermatology, University of Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'Department of Dermatology, University of Lille, Lille, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bernard', 'Affiliation': 'Department of Dermatology, University of Reims, Reims, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Caux', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Avicenne Hospital, Assistance Publique-Hôpitaux de Paris, Department of Dermatology, University of Paris 13, Bobigny, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Alexandre', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Avicenne Hospital, Assistance Publique-Hôpitaux de Paris, Department of Dermatology, University of Paris 13, Bobigny, France.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Ingen-Housz-Oro', 'Affiliation': 'Department of Dermatology, Assistance Publique-Hôpitaux de Paris, Henri Mondor Hospital, Créteil, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vabres', 'Affiliation': 'Department of Dermatology, Dijon University Hospital, Dijon, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Quereux', 'Affiliation': 'Department of Dermatology, University of Nantes, Nantes, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Dupuy', 'Affiliation': 'Department of Dermatology, University of Rennes, Rennes, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Debarbieux', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon Sud, Pierre Bénite, Lyon, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Avenel-Audran', 'Affiliation': 'Department of Dermatology, University of Angers, Angers, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': ""D'Incan"", 'Affiliation': 'Department of Dermatology, University of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bédane', 'Affiliation': 'Department of Dermatology, University of Limoges, Limoges, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bénéton', 'Affiliation': 'Department of Dermatology, Le Mans General Hospital, Le Mans, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Jullien', 'Affiliation': 'Department of Dermatology, Edouard Herriot Hospital, Lyon Claude Bernard University, Lyon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dupin', 'Affiliation': 'Department of Dermatology, University of Paris V, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Misery', 'Affiliation': 'Department of Dermatology, Brest University Hospital, Brest, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, Tours University Hospital, Tours, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beylot-Barry', 'Affiliation': 'Department of Dermatology, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dereure', 'Affiliation': 'Department of Dermatology, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Sassolas', 'Affiliation': 'Department of Internal Medicine, Brest University Hospital, Brest, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Benichou', 'Affiliation': 'Department of Biostatistics and Clinical Research, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Department of Dermatology, Rouen University Hospital, Normandie University, INSERM U1234, Rouen, France.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Hébert', 'Affiliation': 'Centre de référence des maladies bulleuses auto-immunes, Department of Dermatology, Rouen University Hospital, Normandie University, INSERM U1234, Rouen, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA dermatology,['10.1001/jamadermatol.2020.0290']
497,31511290,"Mental health informed physical activity for first responders and their support partner: a protocol for a stepped-wedge evaluation of an online, codesigned intervention.","BACKGROUND


First responders (police, fire and ambulance officers) are at a significantly increased risk of experiencing poor mental health, including depression and post-traumatic stress disorder. These conditions are associated with high rates of cardiovascular disease, in part due to low levels of physical activity (PA) and high levels of sedentary behaviour. Using a person's social support system may be an effective solution to help increase PA levels to improve mental and physical health outcomes. We will examine the efficacy of a group-based online intervention in increasing PA in first responders and their support partners, iteratively codesigned with advisors with lived experience of mental illness among first responders.
METHODS


This study will recruit a convenience sample of self-identified sedentary first responders and their self-selected support partners to a 10-week PA programme delivered through a private Facebook group. We will deliver education on predetermined topics related to PA and diet and provide participants with an activity tracker (Fitbit). A stepped-wedged design will be applied to compare multiple baselines to intervention and follow-up phases within subjects. Five cohorts of n=20 will be recruited, with each cohort randomised to a different baseline length. Our primary outcome will be psychological distress (Kessler-6). Secondary outcomes include feasibility, self-report and objective PA data (Simple Physical Activity Questionnaire and Fitbit accelerometry), depression and anxiety (Depression Anxiety and Stress Scale-21 items), post-traumatic stress disorder symptoms (PTSD Checklist for DSM-5), quality of life Assessment of Quality of Life-6 dimensions, sleep quality (The Pittsburgh Sleep Quality Index), suicidal ideation (Suicidal Ideation Attributes Scale) and social support for exercise. The mobile data collection platform MetricWire will be used.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of New South Wales, Deupty Vice-Chancellor Research, Human Research Ethics Committee on 3 June 2019, HC180561. Findings will be published in peer-reviewed journals and disseminated at national conferences.
TRIAL REGISTRATION NUMBER


ACTRN12619000877189.",2019,"BACKGROUND


First responders (police, fire and ambulance officers) are at a significantly increased risk of experiencing poor mental health, including depression and post-traumatic stress disorder.","['first responders and their support partners, iteratively codesigned with advisors with lived experience of mental illness among first responders', 'convenience sample of self-identified sedentary first responders and their self-selected support partners to a 10-week PA programme delivered through a private Facebook group']","['group-based online intervention', 'PA and diet and provide participants with an activity tracker (Fitbit']","['feasibility, self-report and objective PA data (Simple Physical Activity Questionnaire and Fitbit accelerometry), depression and anxiety (Depression Anxiety and Stress Scale-21 items), post-traumatic stress disorder symptoms (PTSD Checklist for DSM-5), quality of life Assessment of Quality of Life-6 dimensions, sleep quality (The Pittsburgh Sleep Quality Index), suicidal ideation (Suicidal Ideation Attributes Scale) and social support for exercise', 'psychological distress (Kessler-6']","[{'cui': 'C3178988', 'cui_str': 'First Responders'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0034380'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0037438'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.04467,"BACKGROUND


First responders (police, fire and ambulance officers) are at a significantly increased risk of experiencing poor mental health, including depression and post-traumatic stress disorder.","[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McKeon', 'Affiliation': 'School of Psychiatry, UNSW, Sydney, New South Wales, Australia g.mckeon@unsw.edu.au.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Steel', 'Affiliation': 'School of Psychiatry, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Psychiatry, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'School of Psychiatry, UNSW, Sydney, New South Wales, Australia.'}, {'ForeName': 'Davy', 'Initials': 'D', 'LastName': 'Vancampfort', 'Affiliation': 'University Psychiatric Centre KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'School of Psychiatry, UNSW, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-030668']
498,31511291,Informed health choices intervention to teach primary school children in low-income countries to assess claims about treatment effects: process evaluation.,"BACKGROUND


We developed the informed health choices (IHC) primary school resources to teach children how to assess the trustworthiness of claims about the effects of treatments. We evaluated these resources in a randomised trial in Uganda. This paper describes the process evaluation that we conducted alongside this trial.
OBJECTIVES


To identify factors affecting the implementation, impact and scaling up of the intervention; and potential adverse and beneficial effects of the intervention.
METHODS


All 85 teachers in the 60 schools in the intervention arm of the trial completed a questionnaire after each lesson and at the end of the term. We conducted structured classroom observations at all 60 schools. For interviews and focus groups, we purposively selected six schools. We interviewed district education officers, teachers, head teachers, children and their parents. We used a framework analysis approach to analyse the data.
RESULTS


Most of the participants liked the IHC resources and felt that the content was important. This motivated the teachers and contributed to positive attitudes. Although some teachers started out lacking confidence, many found that the children's enthusiasm for the lessons made them more confident. Nearly everyone interviewed thought that the children learnt something important and many thought that it improved their decision-making. The main barrier to scaling up use of the IHC resources that participants identified was the need to incorporate the lessons into the national curriculum.
CONCLUSION


The mostly positive findings reflect the trial results, which showed large effects on the children's and the teachers' critical appraisal skills. The main limitations of this evaluation are that the investigators were responsible for both developing and evaluating the intervention.",2019,"The mostly positive findings reflect the trial results, which showed large effects on the children's and the teachers' critical appraisal skills.","['All 85 teachers in the 60 schools', 'We interviewed district education officers, teachers, head teachers, children and their parents']",[],[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0401924', 'cui_str': 'Education officer (occupation)'}, {'cui': 'C0335018', 'cui_str': 'Head teacher (occupation)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",[],[],85.0,0.0444398,"The mostly positive findings reflect the trial results, which showed large effects on the children's and the teachers' critical appraisal skills.","[{'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Nsangi', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Semakula', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Glenton', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lewin', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Oxman', 'Affiliation': 'Institute of Health and Society, University of Oslo Faculty of Medicine, Oslo, Norway oxman@online.no.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Oxman', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Dahlgren', 'Affiliation': 'Regional Centre for Child and Adolescent Mental Health (Eastern and Southern Norway), Oslo, Norway.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Nyirazinyoye', 'Affiliation': 'Department of Public Health, University of Rwanda, Butare, Rwanda.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kaseje', 'Affiliation': 'Tropical Institute of Community Health and Development, Kisumu, Kenya.'}, {'ForeName': 'Christopher James', 'Initials': 'CJ', 'LastName': 'Rose', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Fretheim', 'Affiliation': 'Institute of Health and Society, University of Oslo Faculty of Medicine, Oslo, Norway.'}, {'ForeName': 'Nelson K', 'Initials': 'NK', 'LastName': 'Sewankambo', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}]",BMJ open,['10.1136/bmjopen-2019-030787']
499,31513248,Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial.,"Importance


Oxaliplatin-based chemotherapy is associated with debilitating peripheral sensory neuropathy (PSN) for patients with stage III colon cancer.
Objective


To assess disease-free survival (DFS) and long-lasting PSN in patients treated with 3 vs 6 months of adjuvant oxaliplatin-based chemotherapy.
Design, Setting, and Participants


An open-label, multicenter, phase 3 randomized clinical trial of 1313 Asian patients with stage III colon cancer was conducted investigating the noninferiority of 3 vs 6 months of adjuvant oxaliplatin-based chemotherapy. From August 1, 2012, to June 30, 2014, participants were randomized to the 2 treatment groups. Data were analyzed from July 2017 to June 2018.
Interventions


Patients were randomized to receive 3 or 6 months of adjuvant chemotherapy. The choice of chemotherapy regimen, with the drugs modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine plus oxaliplatin (CAPOX), was at the discretion of the treating physician.
Main Outcomes and Measures


The primary outcome was DFS. Secondary end points included the evaluation of PSN for up to 3 years and overall survival.
Results


Of the 1313 patients (651 were women and mean age was 66 [range, 28-85] years) enrolled and randomized, 22 were not treated because 10 were unable to begin treatment within 2 weeks of enrollment, 7 withdrew their consent, and 5 were not treated for various other reasons. Of 1291 patients treated (650 in the 3-month arm and 641 in the 6-month arm), 969 (75%) received the chemotherapy drug CAPOX. The hazard ratio (HR) for DFS of the 3-month arm compared with the 6-month arm was 0.95 (95% CI, 0.76-1.20). Hazard ratios were 1.07 (95% CI, 0.71-1.60) and 0.90 (95% CI, 0.68-1.20) for the drugs mFOLFOX6 and CAPOX, and 0.81 (95% CI, 0.53-1.24) and 1.07 (95% CI, 0.81-1.40) for patients with low-risk disease (TNM classification stages T1-3 and N1) and high-risk disease (stages T4 or N2), respectively. The rates of any grade of PSN lasting for 3 years in the 3-month vs 6-month treatment arms were 9.7% vs 24.3% (P < .001). Incidence of PSN lasting for 3 years was significantly lower for patients treated with CAPOX than for patients treated with mFOLFOX6 in both the 3-month (7.9% vs 15.7%; P = .04) and 6-month arms (21.0% vs 34.1%; P = .02).
Conclusions and Relevance


The incidence of long-lasting PSN was significantly lower for 3 months than for 6 months of therapy, and significantly lower for treatment with the drug CAPOX than with mFOLFOX6. Since the shortened therapy duration did not compromise outcomes, a 3-month course of CAPOX may be the most appropriate treatment option, particularly for patients with low-risk disease.
Trial Registration


UMIN Clinical Trials Registry: UMIN000008543.",2019,"Incidence of PSN lasting for 3 years was significantly lower for patients treated with CAPOX than for patients treated with mFOLFOX6 in both the 3-month (7.9% vs 15.7%; P = .04) and 6-month arms (21.0% vs 34.1%; P = .02).
","['1313 patients (651 were women and mean age was 66 [range, 28-85] years) enrolled and randomized, 22 were not treated because 10', 'patients with low-risk disease', 'patients treated with 3 vs 6 months of adjuvant oxaliplatin-based chemotherapy', '1291 patients treated (650 in the 3-month arm and 641 in the 6-month arm), 969 (75%) received the', '1313 Asian patients with stage III colon cancer', 'patients with stage III colon cancer', 'Colon Cancer', 'Data were analyzed from July 2017 to June 2018']","['adjuvant chemotherapy', 'CAPOX', 'Oxaliplatin-Based Adjuvant Chemotherapy', 'adjuvant oxaliplatin-based chemotherapy', 'chemotherapy drug CAPOX', 'Oxaliplatin-based chemotherapy', 'fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine plus oxaliplatin (CAPOX']","['hazard ratio (HR) for DFS', 'disease-free survival (DFS', 'Hazard ratios', 'Incidence of PSN lasting', 'incidence of long-lasting PSN', 'rates of any grade of PSN lasting', 'DFS', 'evaluation of PSN for up to 3 years and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1291.0,0.183742,"Incidence of PSN lasting for 3 years was significantly lower for patients treated with CAPOX than for patients treated with mFOLFOX6 in both the 3-month (7.9% vs 15.7%; P = .04) and 6-month arms (21.0% vs 34.1%; P = .02).
","[{'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Yokohama City University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Kotaka', 'Affiliation': 'Sano Hospital, Hyogo, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Tsuchiura Kyodo General Hospital, Ibaraki, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Hasegawa', 'Affiliation': 'Osaka Rosai Hospital, Osaka, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': 'Hakodate Goryoukaku Hospital, Hokkaido, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Aizawa Hospital, Nagano, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Munemoto', 'Affiliation': 'Fukui-ken Saiseikai Hospital, Fukui, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Takeuchi', 'Affiliation': 'Teine Keijinkai Hospital, Hokkaido, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Kyoto Second Red Cross Hospital, Kyoto, Japan.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Gamoh', 'Affiliation': 'Osaki Citizen Hospital, Miyagi, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Shigetoyo', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2572']
500,31162858,Modeling the economic benefit of targeted mild hypothermia in deceased donor kidney transplantation.,"Delayed graft function (DGF) in kidney transplant significantly increases inpatient and outpatient cost. Targeted, mild hypothermia in organ donors after neurologic determination of death significantly reduced the rate of DGF in a recent randomized controlled clinical trial. To assess the potential economic benefit of national implementation of donor hypothermia, rates of reduction DGF were combined with estimates of the impact of DGF on hospital cost and total health expenditure for standard and extended criteria donor organs (SCD and ECD). DGF increases the cost of the transplant episode by $9487 for ECD transplant and $10 342 for SCD transplant. Medicare recipients with DGF incur an additional $18 513 spending for ECD and $14 948 in SCD transplants over the first year. An absolute reduction in DGF rate after kidney transplantation consistent with trial results (ECD 25%, SCD 7%) has the potential to lower annual hospital cost for kidney transplant by $13 178 746 and annual Medicare spending by $20 970 706 compared to standard donor management practice using static cold storage. Targeted mild hypothermia improves care of renal transplant patients by safely reducing DGF rates in both ECD and SCD transplant. Broader application of this safe, effective, and low-cost intervention could reduce healthcare expenditures for providers and insurers.",2019,DGF increases the cost of the transplant episode by $9487 for ECD transplant and $10 342 for SCD transplant.,"['178\xa0746 and annual Medicare spending by $20', 'deceased donor kidney transplantation', 'Medicare recipients with DGF incur an additional $18\xa0513 spending for ECD and $14\xa0948 in SCD transplants over the first year']",['DGF'],"['DGF rate', 'hospital cost and total health expenditure for standard and extended criteria donor organs (SCD and ECD', 'DGF rates', 'rate of DGF', 'Delayed graft function (DGF', 'cost of the transplant episode']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015318', 'cui_str': 'Health Expenditures'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0348079', 'cui_str': 'Type of donor organ (attribute)'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C1566590', 'cui_str': 'Delayed Graft Function'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}]",,0.0299198,DGF increases the cost of the transplant episode by $9487 for ECD transplant and $10 342 for SCD transplant.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Axelrod', 'Affiliation': 'Department of Transplantation and HPB Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Malinoski', 'Affiliation': 'Section of Surgical Critical Care, VA Portland Health Care System (VAPORHCS), Portland, Oregon.'}, {'ForeName': 'Madhukar S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Section of Surgical Critical Care, VA Portland Health Care System (VAPORHCS), Portland, Oregon.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Tahnee', 'Initials': 'T', 'LastName': 'Groat', 'Affiliation': 'Division of Trauma, Critical Care, and Acute Care Surgery, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lentine', 'Affiliation': 'Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schnitzler', 'Affiliation': 'Center for Abdominal Transplantation, Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Claus U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, California.'}]",Clinical transplantation,['10.1111/ctr.13626']
501,32013106,Sport Education and Sportsmanship Orientations: An Intervention in High School Students.,"One of the main goals for physical education is to develop the students' moral and ethical domain, where sportsmanship promotion is considered a key curricular component to tackle the achievement of this goal. This research aims to examine the influence of sport education on sportsmanship orientations in high school students. The participants were 148 (52.70% female;  M age  = 17.04,  SD age  = 0.99) high school students who were randomized into an experimental group ( n  = 74), which received 16 basketball lessons under sport education conditions, and a control group ( n  = 74), which received 16 basketball lessons following a traditional teaching approach. Pre-intervention and post-intervention measures on sportsmanship orientations were collected in both groups. A 2 (time: pre-test and post-test) x 2 (group: Sport Education and Traditional Teaching) multivariate analysis of variance test was performed on the five sportsmanship orientations. The results showed, for time x group interactions, the absence of significant multivariate effects in the level of the five sportsmanship orientations among both groups at pre-test (Pillai's trace = 0.06,  p  = 0.145). At post-test, significant multivariate effects were found in the level of each sportsmanship orientation between both groups in favor of the Sport Education group (Pillai's trace = 0.38,  p  < 0.001). Furthermore, regarding within-group pre-test to post-test differences, while there were nonsignificant multivariate effects (Pillai's trace = 0.03,  p  = 0.469) for the Traditional Teaching group; significant multivariate effects (Pillai's trace = 0.43,  p  < 0.001) were found for the Sport Education group, showing an increase in the level of respect for social conventions, respect for rules and referees, and full commitment and respect for opponents. There were also nonsignificant effects across gender (inter-group analysis: Pillai's trace = 0.08,  p  = 0.068; time x gender interaction: Pillai's trace = 0.03,  p  = 0.497) and after-school sports (inter-group analysis: Pillai's trace = 0.02,  p  = 0.776; time x after-school interaction: Pillai's trace = 0.01,  p  = 0.981). In conclusion, sport education is an effective pedagogical model to be taken into consideration by physical education teachers in order to optimally promote the high school student's moral and ethical education via the development of sportsmanship orientations in the context of school physical education.",2020,"At post-test, significant multivariate effects were found in the level of each sportsmanship orientation between both groups in favor of the Sport Education group (Pillai's trace = 0.38,  p  < 0.001).","['participants were 148 (52.70% female;  M age  = 17.04,  SD age  = 0.99) high school students', 'high school students', 'High School Students']","['sport education', '16 basketball lessons under sport education conditions, and a control group ( n  = 74), which received 16 basketball lessons following a traditional teaching approach', 'Sport Education and Sportsmanship Orientations']","['level of each sportsmanship orientation', 'level of respect for social conventions, respect for rules and referees, and full commitment and respect for opponents', 'sportsmanship orientations']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517488', 'cui_str': '0.99'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0679133', 'cui_str': 'Respect'}]",148.0,0.0216035,"At post-test, significant multivariate effects were found in the level of each sportsmanship orientation between both groups in favor of the Sport Education group (Pillai's trace = 0.38,  p  < 0.001).","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Burgueño', 'Affiliation': 'Health Research Center, University of Almeria, 04009 Almería, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Medina-Casaubón', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17030837']
502,32022827,Safety and Efficacy of Exposure-Based Risk Reduction Through Family Therapy for Co-occurring Substance Use Problems and Posttraumatic Stress Disorder Symptoms Among Adolescents: A Randomized Clinical Trial.,"Importance


No empirically supported treatments have been evaluated to address co-occurring substance use problems (SUP) and posttraumatic stress disorder (PTSD) symptoms among adolescents in an integrative fashion. This lack is partially owing to untested clinical lore suggesting that delivery of exposure-based PTSD treatments to youth with SUP might be iatrogenic.
Objective


To determine whether an exposure-based, integrative intervention for adolescents with SUP and PTSD symptoms-risk reduction through family therapy (RRFT)-resulted in improved outcomes relative to a treatment-as-usual (TAU) control condition consisting primarily of trauma-focused cognitive behavioral therapy.
Design, Setting, and Participants


This randomized clinical trial enrolled 124 participants who were recruited from November 1, 2012, through January 30, 2017. Adolescents (aged 13-18 years) who engaged in nontobacco substance use at least once during the past 90 days, experienced at least 1 interpersonal traumatic event, and reported 5 or more PTSD symptoms were enrolled. Blinded assessments were collected at baseline and at 3, 6, 12, and 18 months after baseline. Recruitment and treatment took place in community-based child advocacy centers in the Southeastern United States. Data were analyzed from August 2 through October 4, 2018, and were based on intention to treat.
Interventions


Participants were randomized to receive RRFT (n = 61) or TAU (n = 63).
Main Outcomes and Measures


Primary outcomes focused on number of nontobacco substance-using days measured with the timeline follow-back method and PTSD symptom severity using the UCLA (University of California, Los Angeles) PTSD Reaction Index for DSM-IV completed by adolescents and caregivers. Secondary outcomes focused on marijuana, alcohol, and polysubstance use and PTSD criterion standard (re-experiencing, avoidance, and hyperarousal) symptom severity.
Results


In all, 124 adolescents (mean [SD] age, 15.4 [1.3] years; 108 female [87.1%]) were randomized. For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24). Significant reductions in PTSD symptoms were observed within groups for RRFT from baseline to months 3 (β = -9.25; 95% CI, -12.95 to -5.55), 6 (β = -16.63; 95% CI = -20.40 to -12.87), 12 (β = -17.51; 95% CI, -21.62 to -13.40), and 18 (β = -19.02; 95% CI, -23.07 to -14.96) and for TAU from baseline to months 3 (β = -9.62; 95% CI, -13.16 to -6.08), 6 (β = -13.73; 95% CI, -17.43 to -10.03), 12 (β = -15.53; 95% CI, -19.52 to -11.55), and 18 (β = -13.88; 95% CI, -17.69 to -10.09); however, between-group differences were not observed.
Conclusions and Relevance


In this study, RRFT and TAU demonstrated within-group improvements in SUP and PTSD symptoms, with greater improvement for substance use and PTSD avoidance and hyperarousal symptoms among adolescents randomized to RRFT compared with TAU. No evidence of the worsening of SUP was observed in either condition. These results suggest that this exposure-based treatment is safe, feasibly delivered by community-based clinicians, and offers an effective approach to inform clinical practice.
Trial Registration


ClinicalTrials.gov Identifier: NCT01751035.",2020,"For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24).","['124 adolescents (mean [SD] age, 15.4 [1.3] years; 108 female [87.1%]) were randomized', 'community-based child advocacy centers in the Southeastern United States', 'Adolescents (aged 13-18 years) who engaged in nontobacco substance use at least once during the past 90 days, experienced at least 1 interpersonal traumatic event, and reported 5 or more PTSD symptoms were enrolled', 'adolescents with SUP and PTSD symptoms-risk reduction through family', 'Adolescents', '124 participants who were recruited from November 1, 2012, through January 30, 2017']","['treatment-as-usual (TAU) control condition consisting primarily of trauma-focused cognitive behavioral therapy', 'therapy (RRFT)-resulted', 'exposure-based, integrative intervention', 'Exposure-Based Risk Reduction Through Family Therapy', 'TAU', 'RRFT']","['SUP and PTSD symptoms', 'marijuana, alcohol, and polysubstance use and PTSD criterion standard (re-experiencing, avoidance, and hyperarousal) symptom severity', 'worsening of SUP', 'number of nontobacco substance-using days measured with the timeline follow-back method and PTSD symptom severity using the UCLA (University of California, Los Angeles) PTSD Reaction Index for DSM-IV completed by adolescents and caregivers', 'PTSD symptoms', 'substance use and PTSD avoidance and hyperarousal symptoms']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008063', 'cui_str': 'Child Advocacy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]",124.0,0.169046,"For primary outcomes relative to TAU, RRFT yielded significantly greater reductions in substance-using days from baseline to month 12 (event rate [ER], 0.28; 95% CI, 0.12-0.65) and month 18 (ER, 0.10; 95% CI, 0.04-0.24).","[{'ForeName': 'Carla Kmett', 'Initials': 'CK', 'LastName': 'Danielson', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, National Crime Victims Research & Treatment Center, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Adams', 'Affiliation': 'Adolescent Behavioral Health Research Program, Department of Psychiatry, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'McCart', 'Affiliation': 'Oregon Social Learning Center, Eugene.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Chapman', 'Affiliation': 'Oregon Social Learning Center, Eugene.'}, {'ForeName': 'Ashli J', 'Initials': 'AJ', 'LastName': 'Sheidow', 'Affiliation': 'Oregon Social Learning Center, Eugene.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, National Crime Victims Research & Treatment Center, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Smalling', 'Affiliation': 'Dee Norton Child Advocacy Center, Charleston, South Carolina.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'de Arellano', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, National Crime Victims Research & Treatment Center, Medical University of South Carolina, Charleston.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4803']
503,32053133,Assessment of Duration and Effects of 3 vs 6 Months of Adjuvant Chemotherapy in High-Risk Stage II Colorectal Cancer: A Subgroup Analysis of the TOSCA Randomized Clinical Trial.,"Importance


The addition of oxaliplatin to the standard 6-month fluorouracil-based adjuvant chemotherapy in stage II colorectal cancer has been reported to reduce the risk of relapse although it does not increase survival. The Three or Six Colon Adjuvant (TOSCA) trial compared 3 months with 6 months of adjuvant fluoropyrimidine and oxaliplatin-based chemotherapy in patients with stage III colon cancer. The utility remains unknown.
Objective


To assess the noninferiority and toxic effects of 3 vs 6 months of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine plus oxaliplatin) adjunct chemotherapy among patients with high-risk stage II resected colorectal cancer enrolled in the TOSCA trial.
Design, Setting, and Participants


The TOSCA study was a noninferiority phase 3 randomized clinical trial conducted from June 2007 to March 2013 in 130 Italian centers. Included patients had resected colorectal cancer located 12 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery. In this preplanned study assessing the per-protocol population, 5-year relapse-free survival was evaluated in 1254 patients with high-risk stage II resected colorectal cancer who had received adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine plus oxaliplatin).
Interventions


Patients were originally randomized (1:1) in the TOSCA trial to receive 3 months (experimental group) or 6 months (control) of standard doses of FOLFOX or CAPOX at the discretion of the treating physician.
Main Outcome and Measures


A hazard ratio of at least 1.2 between the 3-month and 6-month chemotherapy groups was set to reject the null hypothesis of noninferiority.
Results


Overall, 1254 patients (mean [SD] age, 62.4 [9.8] years; 565 women [45.1%]) with clinical high-risk stage II resected colorectal cancer were analyzed at a median follow-up of 62 months (interquartile range, 53-71) months. Of them, 301 patients (24.0%) had pT4N0M0 tumors, and the remaining 953 patients (76.0%) had high-risk pT3N0M0 tumors; 776 patients (61.9%) received FOLFOX and 478 (38.1%) received CAPOX. The 5-year relapse-free survival was 82.2% for the 3-month arm and 88.2% for the 6-month arm, with an estimated hazard ratio of 1.41 (95% CI, 1.05-1.89; P = .86 for noninferiority). For CAPOX, the 5-year relapse-free survival was similar in the 2 arms (difference, 0.76% favoring the 6-month arm; 95% CI, -6.28% to 7.80%), whereas for FOLFOX, the difference was pronounced: 8.56% in favor of the longer-duration arm (95% CI, 3.45%-13.67%). Nevertheless, the test for an interaction between duration and regimen was not statistically significant. Neurotoxicity was approximately 5 times lower in the shorter duration arm than in the longer duration arm.
Conclusions and Relevance


In the 3-month arm, the treatment was significantly less toxic than in the 6-month arm. Noninferiority was not shown for 5-year relapse-free survival. However, a possible regimen effect was observed, suggesting that either 3 months of CAPOX or 6 months of FOLFOX therapy can be used whenever an oxaliplatin doublet is indicated for treatment of patients with stage II colorectal cancer.
Trial Registration


ClinicalTrials.gov Identifier: NCT0064660.",2020,"The 5-year relapse-free survival was 82.2% for the 3-month arm and 88.2% for the 6-month arm, with an estimated hazard ratio of 1.41 (95% CI, 1.05-1.89; P = .86 for noninferiority).","['Included patients had resected colorectal cancer located 12 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery', '1254 patients (mean [SD] age, 62.4 [9.8] years; 565 women [45.1%]) with clinical high-risk stage II resected colorectal cancer', 'High-Risk Stage II Colorectal Cancer', 'patients with high-risk stage II resected colorectal cancer enrolled in the TOSCA trial', 'patients with stage III colon cancer', 'June 2007 to March 2013 in 130 Italian centers', '1254 patients with high-risk stage II resected colorectal cancer who had received', 'stage II colorectal cancer', 'patients with stage II colorectal cancer']","['FOLFOX', 'fluorouracil-based adjuvant chemotherapy', 'FOLFOX or CAPOX', 'adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine plus oxaliplatin', 'oxaliplatin', 'Adjuvant Chemotherapy', 'FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine plus oxaliplatin) adjunct chemotherapy', 'adjuvant fluoropyrimidine and oxaliplatin-based chemotherapy', 'CAPOX']","['toxic', '5-year relapse-free survival', 'noninferiority and toxic effects', 'Neurotoxicity']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0227423', 'cui_str': 'Structure of transition zone of anal mucous membrane'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}]",1254.0,0.297002,"The 5-year relapse-free survival was 82.2% for the 3-month arm and 88.2% for the 6-month arm, with an estimated hazard ratio of 1.41 (95% CI, 1.05-1.89; P = .86 for noninferiority).","[{'ForeName': 'Fausto', 'Initials': 'F', 'LastName': 'Petrelli', 'Affiliation': 'Medical Oncology Unit, Medical Science Department, American SamoaST Bergamo Ovest, Treviglio (BG), Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Galli', 'Affiliation': 'Laboratory of Clinical Research Methodology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Clinical Research Methodology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Medical Oncology Unit, Fondazione Istituto Nazionale Tumori-IRCCS, Milano, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Medical Oncology Unit, Ospedale San Raffaele-IRCCS, Milano, Italy.'}, {'ForeName': 'Giovanni Gerardo', 'Initials': 'GG', 'LastName': 'Cardellino', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Mattioli', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera Santa Croce, Fano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mambrini', 'Affiliation': 'Medical Oncology Unit Massa Carrara, Azienda Toscana Nordovest, Italy.'}, {'ForeName': 'Libero', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Molinette, Torino, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Pusceddu', 'Affiliation': 'Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology Unit, Hospital Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zampino', 'Affiliation': 'Gastrointestinal Medical Oncology Unit and Neuroendocrine Tumors, Istituto Europeo di Oncologia-IRCCS, Milano, Italy.'}, {'ForeName': 'Vittorina', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""Medical Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome and IDI-IRCCS, Roma, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Corsi', 'Affiliation': 'Medical Oncology Unit Azienda Ospedaliera San Giovanni Calibita Fatebenefratelli Roma, Italy.'}, {'ForeName': 'Lorenza', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, Rozzano (Milano), Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology Unit, Ospedale di Summa A. Perrino Brindisi, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology Unit, IRCCS San Martino-IST, Genova, Italy.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6486']
504,32056311,"World Health Organization risk drinking level reductions are associated with improved functioning and are sustained among patients with mild, moderate and severe alcohol dependence in clinical trials in the United States and United Kingdom.","AIMS


To examine whether World Health Organization (WHO) risk-level reductions in drinking were achievable, associated with improved functioning and maintained over time among patients at varying initial alcohol dependence severity levels. Design and setting Secondary data analysis of multi-site randomized clinical trials: the US Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) study and the UK Alcohol Treatment Trial (UKATT).
PARTICIPANTS


Individuals with alcohol dependence enrolled in COMBINE (n = 1383; 68.8% male) and seeking treatment for alcohol problems in UKATT (n = 742; 74.1% male). Interventions Naltrexone, acamprosate or placebo, and combined behavioral intervention or medication management in COMBINE. Social behavior network therapy or motivational enhancement therapy in UKATT.
MEASUREMENTS


WHO risk-level reductions were assessed via the calendar method. Alcohol dependence was measured by the Alcohol Dependence Scale, the Leeds Dependence Questionnaire and the Diagnostic and Statistical Manual of Mental Disorders. Measures of functioning included alcohol-related consequences (Drinker Inventory of Consequences and Alcohol Problems Questionnaire), mental health (Short Form Health Survey) and liver enzyme tests.
FINDINGS


One- and two-level reductions in WHO risk levels in the last month of treatment were maintained at the 1-year follow-up [adjusted odds ratio (OR), 95% confidence interval (CI) = one-level reduction in COMBINE: 3.51 (2.73, 4.29) and UKATT: 2.65 (2.32, 2.98)] and associated with fewer alcohol-related consequences [e.g. B, 95% CI = one-level reduction COMBINE: -26.22 (-30.62, -21.82)], better mental health [e.g. B, 95% CI = one-level reduction UKATT: 9.53 (7.36, 11.73)] and improvements in γ-glutamyltransferase [e.g. B, 95% CI = one-level reduction UKATT: -89.77 (-122.50, -57.04)] at the end of treatment, even among patients with severe alcohol dependence. Results were similar when abstainers were excluded. Conclusions Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning and maintained over time in both the United States and the United Kingdom.",2020,"Results were similar when abstainers were excluded CONCLUSIONS: Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning, and maintained over time in both the United States and the United Kingdom.",['Individuals with alcohol dependence enrolled in COMBINE (n=1383; 68.8% male) and seeking treatment for alcohol problems in UKATT (n=742; 74.1% male'],"['Social behavior network therapy or motivational enhancement therapy', 'Naltrexone, acamprosate, or placebo, and combined behavioral intervention or medication management']","['Alcohol dependence', 'functioning included alcohol-related consequences (Drinker Inventory of Consequences and Alcohol Problems Questionnaire), mental health (Short Form Health Survey), and liver enzyme tests', 'better mental health', 'Alcohol Dependence Scale, the Leeds Dependence Questionnaire, and the Diagnostic and Statistical Manual of Mental Disorders', 'WHO risk level reductions', 'WHO risk levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]","[{'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0284941', 'cui_str': 'acamprosate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0450984', 'cui_str': 'Alcohol dependence scale (assessment scale)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0432415,"Results were similar when abstainers were excluded CONCLUSIONS: Reductions in World Health Organization risk levels for alcohol consumption appear to be achievable, associated with better functioning, and maintained over time in both the United States and the United Kingdom.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heather', 'Affiliation': 'Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.'}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Hasin', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Mann', 'Affiliation': 'Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.15011']
505,31825471,Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure: Secondary Analysis of the Open-label Extension of the PIONEER-HF Trial.,"Importance


In PIONEER-HF, among stabilized patients with acute decompensated heart failure (ADHF), the in-hospital initiation of sacubitril/valsartan was well tolerated and led to improved outcomes compared with enalapril. However, there are limited data comparing the strategies of in-hospital vs postdischarge initiation of sacubitril/valsartan.
Objective


To describe changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients recently hospitalized for ADHF and switching from taking enalapril to taking sacubitril/valsartan after discharge and compare clinical outcomes for patients randomized to receive in-hospital initiation of sacubitril/valsartan vs in-hospital initiation of enalapril who later switched to taking sacubitril/valsartan during an open-label extension phase.
Interventions


Sacubitril/valsartan titrated to 97/103 mg twice daily.
Design, Setting, and Participants


The PIONEER-HF trial was a multicenter, randomized, double-blind, active-controlled trial conducted at 129 US sites between May 2016 and May 2018 that compared the in-hospital initiation of sacubitril/valsartan vs enalapril (titrated to target dose, 10 mg twice daily) for 8 weeks among patients admitted for ADHF with reduced ejection fraction and hemodynamic stability. All patients were to continue in a 4-week, open-label study of sacubitril/valsartan; of 881 patients enrolled in PIONEER-HF, 832 (94%) continued in the open-label study.
Main Outcomes and Measures


Changes in NT-proBNP levels from week 8 to 12 as well as the exploratory composite of heart failure rehospitalization or cardiovascular death from randomization through week 12.
Results


Of 881 participants, 226 (27.7%) were women, 487 (58.5%) were white, 297 (35.7%) were black, 15 (1.8%) were Asian, and 73 (8.8%) were of Hispanic ethnicity; the mean (SD) age was 61 (14) years. For patients who continued to take sacubitril/valsartan, NT-proBNP levels declined -17.2% (95% CI, -3.2 to -29.1) from week 8 to 12. The NT-proBNP levels declined to a greater extent for those switching from taking enalapril to sacubitril/valsartan after the week 8 visit (-37.4%; 95% CI, -28.1 to -45.6; P < .001; comparing changes in 2 groups). Over the entire 12 weeks of follow-up, patients that began taking sacubitril/valsartan in the hospital had a lower hazard for the composite outcome compared with patients that initiated enalapril in the hospital and then had a delayed initiation of sacubitril/valsartan 8 weeks later (hazard ratio, 0.69; 95% CI 0.49-0.97).
Conclusions and Relevance


Switching patients' treatment from enalapril to sacubitril/valsartan at 8 weeks after randomization led to a further 37% reduction in NT-proBNP levels in patients with heart failure with reduced ejection fraction and a recent hospitalization for ADHF.
Trial Registration


ClinicalTrials.gov identifier: NCT02554890.",2020,"The NT-proBNP levels declined to a greater extent for those switching from taking enalapril to sacubitril/valsartan after the week 8 visit (-37.4%; 95% CI, -28.1 to -45.6; P < .001; comparing changes in 2 groups).","['881 participants, 226 (27.7%) were women, 487 (58.5%) were white, 297 (35.7%) were black, 15 (1.8%) were Asian, and 73 (8.8%) were of Hispanic ethnicity', 'After Acute Decompensated Heart Failure', '129 US sites between May 2016 and May 2018 that compared the in-hospital initiation of', 'patients with heart failure with reduced ejection fraction and a recent hospitalization for ADHF', 'patients recently hospitalized for ADHF and switching from taking', 'stabilized patients with acute decompensated heart failure (ADHF', '881 patients enrolled in PIONEER-HF, 832 (94%) continued in the open-label study', 'patients admitted for ADHF with reduced ejection fraction and hemodynamic stability']","['sacubitril/valsartan', 'enalapril', 'enalapril who later switched to taking sacubitril/valsartan', 'Sacubitril/valsartan', 'enalapril to taking sacubitril/valsartan', 'sacubitril/valsartan vs enalapril', 'enalapril to sacubitril/valsartan', 'Angiotensin-Neprilysin Inhibition']","['NT-proBNP levels', 'exploratory composite of heart failure rehospitalization or cardiovascular death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0581377', 'cui_str': 'Decompensated cardiac failure (disorder)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003018', 'cui_str': 'Angiotensins'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",881.0,0.137719,"The NT-proBNP levels declined to a greater extent for those switching from taking enalapril to sacubitril/valsartan after the week 8 visit (-37.4%; 95% CI, -28.1 to -45.6; P < .001; comparing changes in 2 groups).","[{'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Department of Cardiology, Kaiser Permanente San Francisco Medical Center, San Francisco, California.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute, Department of Medicine, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McCague', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rocha', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.4665']
506,31463874,Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection.,"PURPOSE


The DNA fragmentation in sperm is associated with reduced outcome in assisted reproduction. Using YoPro1 as the staining dye and flow cytometry and sorting (FACS), the number of spermatozoa with DNA fragmentation can be lowered to 5%. Can the cumulative outcome of ICSI be improved using FACS?
METHODS


A prospective, randomized, double-blind clinical trial was conducted in 104 infertile couples with male infertility based on abnormal conventional semen analysis results. Cumulative ongoing pregnancy rate was the primary outcome parameter. In 52 cases, semen was processed for ICSI using swim-up. In another 52 cases, spermatozoa with fragmented DNA were removed with FACS.
RESULTS


The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up. An interim analysis scheduled before initiation of the study after 100 cases demonstrated that the aim of a 20% gain in pregnancy rate could not be achieved. For that reason, the prospective study was stopped prematurely.
CONCLUSIONS


A trend towards consistently better results was achieved by removing spermatozoa with fragmented DNA. The fragmentation of the DNA in sperm is the end stage of apoptosis. Sorting of spermatozoa may be improved by selecting parameters of processes active more upstream of apoptosis, such as chromatin decondensation.
TRIAL REGISTRATION


NCT02166567 . June 14, 2014.",2019,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,['104 infertile couples with male infertility based on abnormal conventional semen analysis results'],[],"['Cumulative ongoing pregnancy rate', 'pregnancy rate', 'cumulative pregnancy rate', 'live birth rate', 'miscarriage rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.368995,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'De Geyter', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland. christian.degeyter@usb.ch.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Gobrecht-Keller', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ahler', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-019-01571-1']
507,32189165,A mobile terminal application program was used for endotracheal tube cuff pressure measurement.,"We studied the application of a mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement to improve the implementation rate of scientific ETT cuff pressure measurement and to ensure that the pressure falls within the recommended range. A pre-post controlled study lasting for 18 months was undertaken in a 40-bed general intensive care unit (GICU). This included a 6-month baseline period (baseline group) and a 6-month intervention period (intervention group). The mobile terminal application program was applied to monitor the cuff pressure of endotracheal intubation as an intervention measure during the intervention period. ETT pressure was the main outcome measure, while gender, age, causes for ICU admission, sedation score, duration of prior intubation, size of ETT, and number of VAP patients were secondary outcomes. ETT cuff pressure was monitored 742 times in both the baseline group and the intervention group. A total of 56.9% of the cuff pressure measurements in the baseline group were within the recommended range, while 78.4% of measurements in the intervention group were within the recommended range, reflecting a statistically significant difference (P < 0.05). The application of the mobile terminal application program used for ETT cuff pressure measurement could improve the percentage of ETT cuff pressure measurements falling within the recommended range.",2020,We studied the application of a mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement to improve the implementation rate of scientific ETT cuff pressure measurement and to ensure that the pressure falls within the recommended range.,['18\xa0months was undertaken in a 40-bed general intensive care unit (GICU'],['mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement'],"['ETT cuff pressure', 'ICU admission, sedation score, duration of prior intubation, size of ETT, and number of VAP', 'cuff pressure measurements']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.0263321,We studied the application of a mobile terminal application program in endotracheal tube (ETT) cuff pressure measurement to improve the implementation rate of scientific ETT cuff pressure measurement and to ensure that the pressure falls within the recommended range.,"[{'ForeName': 'Wei-Zhong', 'Initials': 'WZ', 'LastName': 'Wang', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China. 906134210@qq.com.""}, {'ForeName': 'Yao-Ying', 'Initials': 'YY', 'LastName': 'Zhou', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Zhi-Juan', 'Initials': 'ZJ', 'LastName': 'Wang', 'Affiliation': ""Nursing Department, Shaoxing People's Hospital, Shaoxing, Zhejiang, China.""}, {'ForeName': 'Mei-Li', 'Initials': 'ML', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Shaoxing People's Hospital, Shaoxing, Zhejiang, China.""}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yao', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Jian-Di', 'Initials': 'JD', 'LastName': 'Yu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Lin', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Fei-Yun', 'Initials': 'FY', 'LastName': 'Yu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Hui-Hui', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lou', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}, {'ForeName': 'Yue-Hong', 'Initials': 'YH', 'LastName': 'Hu', 'Affiliation': ""Department of General Intensive Care Unit, Shaoxing People's Hospital, Zhongxing North Road, Shaoxing, 312000, Zhejiang, China.""}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00499-7']
508,32492087,Efficacy and Safety of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial.,"Importance


Abrocitinib, an oral, once-daily Janus kinase 1 selective inhibitor, was effective and well tolerated in a phase 3 monotherapy trial of patients with moderate-to-severe atopic dermatitis (AD).
Objective


To investigate the efficacy and safety of abrocitinib in adolescents and adults with moderate-to-severe AD in an identically designed trial.
Design, Setting, and Participants


This phase 3, double-blinded, placebo-controlled, parallel-group randomized clinical trial included patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months. Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019. Data were analyzed from September 13 to October 25, 2019.
Interventions


Patients were randomly assigned (2:2:1) to receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo for 12 weeks.
Main Outcomes and Measures


The coprimary end points were the proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75) at week 12. Key secondary end points included the proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points) at week 12. Other secondary end points included the proportion of patients achieving at least 90% improvement in EASI score (EASI-90). Safety was assessed via adverse events and laboratory monitoring.
Results


A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78, placebo. Among patients with available data at week 12, greater proportions of patients in the 200- and 100-mg abrocitinib groups vs the placebo group achieved IGA (59 of 155 [38.1%] and 44 of 155 [28.4%] vs 7 of 77 [9.1%]; P < .001) and EASI-75 (94 of 154 [61.0%] and 69 of 155 [44.5%] vs 8 of 77 [10.4%]; P < .001), greater estimated proportions achieved PP-NRS (55.3% [95% CI, 47.2%-63.5%] and 45.2% [95% CI, 37.1%-53.3%] vs 11.5% [95% CI, 4.1%-19.0%]; P < .001), and/or greater proportions achieved EASI-90 (58 of 154 [37.7%] and 37 of 155 [23.9%] vs 3 of 77 [3.9%]) responses. Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group. Decreases in platelet count (2 [1.3%]) and laboratory values indicating thrombocytopenia (5 [3.2%]) were reported in the 200-mg group.
Conclusions and Relevance


Monotherapy with once-daily oral abrocitinib was effective and well tolerated in adolescents and adults with moderate-to-severe AD.
Trial Registration


ClinicalTrials.gov Identifier: NCT03575871.",2020,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","['patients with moderate-to-severe atopic dermatitis (AD', 'adolescents and adults with moderate-to-severe AD', 'Patients were enrolled from 115 centers in Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, South Korea, Latvia, Poland, United Kingdom, and the United States from June 29, 2018, to August 13, 2019', 'Patients With Moderate-to-Severe Atopic Dermatitis', 'A total of 391 patients (229 male [58.6%]; mean [SD] age, 35.1 [15.1] years) were included in the analysis; of these, 155 received abrocitinib, 200 mg/d; 158, abrocitinib, 100 mg/d; and 78', 'adolescents and adults with moderate-to-severe AD in an identically designed trial', 'patients 12 years or older with a clinical diagnosis of moderate-to-severe AD for at least 1 year and inadequate response to topical medications given for at least 4 weeks within 6 months']","['Abrocitinib', 'abrocitinib', 'receive once-daily oral abrocitinib in 200- or 100-mg doses or placebo', 'placebo']","['Efficacy and Safety', 'platelet count', 'Adverse events', 'proportion of patients achieving a Peak Pruritus Numerical Rating Scale (PP-NRS) response (ie, improvement of ≥4 points', 'EASI-90', 'PP-NRS', 'thrombocytopenia', 'efficacy and safety', 'serious adverse events', 'EASI-75', 'proportion of patients achieving Investigator Global Assessment (IGA) response (ie, clear [0] or almost clear [1], with improvement of ≥2 grades) and the proportion of patients achieving at least 75% improvement in Eczema Area and Severity Index score (EASI-75', 'proportion of patients achieving at least 90% improvement in EASI score (EASI-90', 'IGA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0420210', 'cui_str': 'Medication given'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",391.0,0.644566,"Adverse events were reported for 102 patients (65.8%) in the 200-mg group, 99 (62.7%) in the 100-mg group, and 42 (53.8%) in the placebo group; serious adverse events were reported for 2 patients (1.3%) in the 200-mg group, 5 (3.2%) in the 100-mg group, and 1 (1.3%) in the placebo group.","[{'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Centre for Dermatology, Queen's University and Probity Medical Research, Peterborough, Ontario, Canada.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Feeney', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Pinaki', 'Initials': 'P', 'LastName': 'Biswas', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Valdez', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc, New York, New York.'}, {'ForeName': 'Chudy', 'Initials': 'C', 'LastName': 'Nduaka', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rojo', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}]",JAMA dermatology,['10.1001/jamadermatol.2020.1406']
509,26813209,Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial.,"IMPORTANCE


Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring.
OBJECTIVE


To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood.
DESIGN, SETTING, AND PARTICIPANTS


The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued.
INTERVENTIONS


Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D.
MAIN OUTCOMES AND MEASURES


Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels.
RESULTS


Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001).
CONCLUSIONS AND RELEVANCE


In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00920621.",2016,"Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051).","['Four hundred forty women', 'Asthma or Recurrent Wheezing in Offspring by Age 3 Years', 'Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma', 'pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of', '3 centers across the United States', ' and 436 women', 'Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes', 'The Vitamin D Antenatal Asthma Reduction Trial']","['prenatal vitamin D (cholecalciferol) supplementation', 'placebo', 'daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D', 'placebo plus a prenatal vitamin containing 400 IU vitamin D', 'vitamin D', 'Prenatal Supplementation With Vitamin D']","['vitamin D levels', 'incidence of asthma and recurrent wheezing', 'asthma or recurrent wheeze', 'blood levels', '25-hydroxyvitamin D levels', 'Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4517778', 'cui_str': '4400 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0005768'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",440.0,0.743499,"Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051).","[{'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Harshfield', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'McElrath', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts3Department of Obstetrics and Gynecology, Brigham & Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Sandel', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Iverson', 'Affiliation': 'Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Lee-Paritz', 'Affiliation': 'Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Strunk', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri8St Louis Children's Hospital, St Louis, Missouri.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St Louis, Missouri8St Louis Children's Hospital, St Louis, Missouri.""}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Kaiser Permanente Southern California, San Diego, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': 'Kaiser Permanente Southern California, San Diego, California.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Hornsby', 'Affiliation': ""King's College London School of Medicine, Asthma, Allergy and Respiratory Science, Guy's Hospital Campus, London, United Kingdom.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hawrylowicz', 'Affiliation': ""King's College London School of Medicine, Asthma, Allergy and Respiratory Science, Guy's Hospital Campus, London, United Kingdom.""}, {'ForeName': 'Ann Chen', 'Initials': 'AC', 'LastName': 'Wu', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts13Department of Population Medicine, Harvard Pilgrim Health Care Institute and Children's Hospital Boston, Boston, Massachusetts.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2015.18589']
510,32173214,"Effects of a short health education intervention on physical activity, arterial stiffness and cardiac autonomic function in individuals with moderate-to-high cardiovascular risk.","OBJECTIVE


This study evaluated the effects of a short health education and counseling intervention program, in a primary healthcare setting, on daily physical activity (PA), arterial stiffness, and cardiac autonomic function in individuals with moderate-to-high risk of cardiovascular disease.
METHODS


This was a parallel-group study with a 4-month-long intervention, plus 8 months of follow-up. 164 individuals with moderate-to-high cardiovascular risk were allocated to either an intervention (n = 87) or a control group (n = 77). The intervention consisted of 3 walking and face-to-face group sessions plus text messages. Primary outcome was daily PA (sedentary time, light and moderate-to-vigorous PA, all in min/day); secondary outcomes were arterial stiffness i.e., carotid-femoral pulse wave velocity (cfPWV, m/s)] and cardiac autonomic function [(i.e., standard deviation of all N-N intervals (SDNN, ms) and absolute high frequency (HF, ms 2 )].
RESULTS


There were not significant group*time interactions for sedentary time [-7.4 (7.6); p = 0.331)], light PA [4.4 (6.4); p = 0.491] or moderate-to-vigorous PA [0.1 (2.6); p = 0.938]. Considering secondary outcomes, there were not significant group*time interactions for cfPWV [0.09 (0.18); p = 0.592], Ln_SDNN [0.09 (0.06); p = 0.148], or Ln_HF [0.16 (0.14); p = 0.263].
CONCLUSION


The program did not improve daily PA, arterial stiffness, or the autonomic cardiac function.
PRACTICE IMPLICATIONS


Primary care staff should consider longer or other types of intervention to improve daily PA.",2020,"There were not significant group*time interactions for sedentary time [-7.4 (7.6); p = 0.331)], light PA [4.4 (6.4); p = 0.491] or moderate-to-vigorous PA [0.1 (2.6); p = 0.938].","['individuals with moderate-to-high cardiovascular risk', '164 individuals with moderate-to-high cardiovascular risk', 'individuals with moderate-to-high risk of cardiovascular disease']","['3 walking and face-to-face group sessions plus text messages', 'short health education intervention', 'short health education and counseling intervention program']","['daily physical activity (PA), arterial stiffness, and cardiac autonomic function', 'daily PA (sedentary time, light and moderate-to-vigorous PA, all in min/day); secondary outcomes were arterial stiffness i.e., carotid-femoral pulse wave velocity (cfPWV, m/s)] and cardiac autonomic function [(i.e., standard deviation of all N-N intervals (SDNN, ms) and absolute high frequency (HF, ms 2 ', 'daily PA, arterial stiffness, or the autonomic cardiac function', 'physical activity, arterial stiffness and cardiac autonomic function', 'light PA']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439493', 'cui_str': 'meter/second'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]",164.0,0.0307433,"There were not significant group*time interactions for sedentary time [-7.4 (7.6); p = 0.331)], light PA [4.4 (6.4); p = 0.491] or moderate-to-vigorous PA [0.1 (2.6); p = 0.938].","[{'ForeName': 'Lucimére', 'Initials': 'L', 'LastName': 'Bohn', 'Affiliation': 'Research Centre in Physical Activity, Health and Leisure. Faculty of Sport, University of Porto, Rua Dr. Plácido Costa, 91, 4200.450, Porto, Portugal. Electronic address: lucimerebohn@fade.up.pt.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Sa-Couto', 'Affiliation': 'Center for Research and Development in Mathematics and Applications (CIDMA), Department of Mathematics (DMAT), University of Aveiro, Aveiro, Portugal. Electronic address: p.sa.couto@ua.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ramoa Castro', 'Affiliation': 'Primary Care Centre Espaço Saúde, Aldoar, Porto, Portugal. Electronic address: anaramoacastro@gmail.com.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'School of Health Sciences and Institute of Biomedicine-iBiMED, University of Aveiro, Aveiro, Portugal. Electronic address: fernando.ribeiro@ua.pt.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Sport, University of Porto, Research Centre in Physical Activity, Health and Leisure, Porto, Portugal. Electronic address: joliveira@fade.up.pt.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.005']
511,31566680,Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial.,"Importance


A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit.
Objective


To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone.
Design, Setting, and Participants


In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019.
Interventions


The adjuvant chemotherapy regimen was selected by the treating physician.
Main Outcomes and Measures


Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]).
Results


Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
Conclusions and Relevance


The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population.
Trial Registration


ClinicalTrials.gov identifier: NCT00310180.",2020,"At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
","['1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100', 'women with a high RS who received', 'Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100', '9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100']","['cyclophosphamide/methotrexate/5-fluorouracil', 'taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy', 'endocrine therapy alone', 'adjuvant chemotherapy in addition to endocrine therapy', 'anthracycline without a taxane', 'docetaxel/cyclophosphamide', 'adjuvant chemotherapy plus endocrine therapy', 'anthracycline and taxane', 'Adjuvant Chemotherapy Plus Endocrine Therapy']","['Measures\n\n\nFreedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS', 'estimated rate of freedom from recurrence of breast cancer', 'freedom of recurrence of breast cancer', 'overall survival']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1389.0,0.21629,"At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%).
","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Sparano', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gray', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Della F', 'Initials': 'DF', 'LastName': 'Makower', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Medical Center, Maywood, Illinois.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Saphner', 'Affiliation': 'Aurora Cancer Center (formerly Vince Lombardi Cancer Clinic), Two Rivers, Wisconsin.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Badve', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Kaklamani', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Maccon M', 'Initials': 'MM', 'LastName': 'Keane', 'Affiliation': 'Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gomez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru.'}, {'ForeName': 'Pavan S', 'Initials': 'PS', 'LastName': 'Reddy', 'Affiliation': 'Cancer Center of Kansas, Wichita, Kansas.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Goggins', 'Affiliation': 'Fox Valley Hematology and Oncology, Appleton, Wisconsin.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Mayer', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Brufsky', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Berenberg', 'Affiliation': 'University of Hawaii Cancer Center, Honolulu, Hawaii.'}, {'ForeName': 'Catalin', 'Initials': 'C', 'LastName': 'Mahalcioiu', 'Affiliation': 'McGill University, Montreal, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Desbiens', 'Affiliation': 'Universite Laval, Quebec, Canada.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'the Massey Cancer Center, Virginia Commonwealth University School of Medicine, Richmond.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Wood', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Lively', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NSABP Pathology Office, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Washington University, St Louis, Missouri.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': 'National Institutes of Health, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Indiana University Hospital, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2019.4794']
512,32053149,HSD3B1 Genotype and Clinical Outcomes in Metastatic Castration-Sensitive Prostate Cancer.,"Importance


The adrenal-restrictive HSD3B1(1245A) allele limits extragonadal dihydrotestosterone synthesis, whereas the adrenal-permissive HSD3B1(1245C) allele augments extragonadal dihydrotestosterone synthesis. Retrospective studies have suggested an association between the adrenal-permissive allele, the frequency of which is highest in white men, and early development of castration-resistant prostate cancer (CRPC).
Objective


To examine the association between the adrenal-permissive HSD3B1(1245C) allele and early development of CRPC using prospective data.
Design, Setting, and Participants


The E3805 Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a large, multicenter, phase 3 trial of castration with or without docetaxel treatment in men with newly diagnosed metastatic prostate cancer. From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples. In this study, the HSD3B1 germline genotype was retrospectively determined in 475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype. Data analysis was performed from July 28, 2006, to October 17, 2018.
Interventions


Men were randomized to castration plus docetaxel, 75 mg/m2, every 3 weeks for 6 cycles or castration alone.
Main Outcomes and Measures


Two-year freedom from CRPC and 5-year overall survival, with results stratified by disease volume. Patients were combined across study arms according to genotype to assess the overall outcome associated with genotype. Secondary analyses by treatment arm evaluated whether the docetaxel outcome varied with genotype.
Results


Of 475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele). Mean (SD) age was 63 (8.7) years. Freedom from CRPC at 2 years was diminished in men with low-volume disease with the adrenal-permissive vs adrenal-restrictive genotype: 51.0% (95% CI, 40.9%-61.2%) vs 70.5% (95% CI, 60.0%-80.9%) (P = .01). Overall survival at 5 years was also worse in men with low-volume disease with the adrenal-permissive genotype: 57.5% (95% CI, 47.4%-67.7%) vs 70.8% (95% CI, 60.3%-81.3%) (P = .03). Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death. There was no association between genotype and outcomes in men with high-volume disease. There was no interaction between genotype and benefit from docetaxel.
Conclusions and Relevance


Inheritance of the adrenal-permissive HSD3B1 genotype is associated with earlier castration resistance and shorter overall survival in men with low-volume metastatic prostate cancer and may help identify men more likely to benefit from escalated androgen receptor axis inhibition beyond gonadal testosterone suppression.",2020,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","['Mean (SD) age was 63 (8.7) years', 'men with newly diagnosed metastatic prostate cancer', '475 white men with DNA samples, 270 patients (56.8%) inherited the adrenal-permissive genotype (≥1 HSD3B1[1245C] allele', 'From July 28, 2006, through December 31, 2012, 790 patients underwent randomization, of whom 527 had available DNA samples', 'men with high-volume disease', 'men with low-volume metastatic prostate cancer', 'Interventions\n\n\nMen', '475 white men treated in E3805 CHAARTED, and clinical outcomes were analyzed by genotype', 'Metastatic Castration-Sensitive Prostate Cancer']","['castration alone', 'castration with or without docetaxel treatment', 'castration plus docetaxel', 'E3805 Chemohormonal Therapy vs Androgen Ablation']","['Measures\n\n\nTwo-year freedom from CRPC and 5-year overall survival', 'Overall survival', 'Hazard ratios', 'docetaxel outcome varied with genotype', 'overall survival']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",475.0,0.105053,"Hazard ratios were 1.89 (95% CI, 1.13-3.14; P = .02) for CRPC and 1.74 (95% CI, 1.01-3.00; P = .045) for death.","[{'ForeName': 'Jason W D', 'Initials': 'JWD', 'LastName': 'Hearn', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Almassi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Reichard', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chandana A', 'Initials': 'CA', 'LastName': 'Reddy', 'Affiliation': 'Department of Radiation Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hobbs', 'Affiliation': 'Cancer Biostatistics Section, Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Jarrard', 'Affiliation': 'Department of Medical Oncology, University of Wisconsin Hospital and Clinics, Madison.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'University of Virginia Cancer Center, Charlottesville.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'Department of Medical Oncology, University of Kentucky, Lexington.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Sharifi', 'Affiliation': 'GU Malignancies Research Center, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}]",JAMA oncology,['10.1001/jamaoncol.2019.6496']
513,31999300,Visual Field Changes Over 5 Years in Patients Treated With Panretinal Photocoagulation or Ranibizumab for Proliferative Diabetic Retinopathy.,"Importance


Preservation of peripheral visual field (VF) is considered an advantage for anti-vascular endothelial growth factor agents compared with panretinal photocoagulation (PRP) for treatment of proliferative diabetic retinopathy. Long-term data on VF are important when considering either treatment approach.
Objective


To further evaluate changes in VF throughout 5 years among eyes enrolled in the Protocol S clinical trial, conducted by the DRCR Retina Network.
Design, Setting, and Participants


Post hoc analyses of an ancillary study within a multicenter (55 US sites) randomized clinical trial. Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included. Data were collected from February 2012 to February 2018. Analysis began in June 2018.
Interventions


Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab. Diabetic macular edema, whenever present, was treated with ranibizumab in both groups. Panretinal photocoagulation could be administered to eyes in the ranibizumab group when failure or futility criteria were met.
Main Outcomes and Measures


Mean change in total point score on VF testing with the Humphrey Field Analyzer 30-2 and 60-4 test patterns.
Results


Of 394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study. Of these, 167 (71.4%) had VF meeting acceptable quality criteria at baseline (median [interquartile range] age, 50 [43-58] years; 90 men [53.9%]). At 5 years, 79 (33.8%) had results available. The mean (SD) change in total point score in the PRP and ranibizumab groups was -305 (521) dB and -36 (486) dB at 1 year, respectively, increasing to -527 (635) dB and -330 (645) dB at 5 years, respectively (P = .04). After censoring VF results after PRP treatments in the ranibizumab group, the 5-year mean change in total point score was -201 (442) dB. In a longitudinal regression analysis of change in total point score including both treatment groups, laser treatment was associated with a mean point decrease of 208 (95% CI, 112-304) dB for the initial PRP session, 77 (95% CI, 21-132) dB for additional PRP sessions, and 325 (95% CI, 211-439) dB for endolaser. No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
Conclusions and Relevance


The limited data available from Protocol S suggest that there are factors besides PRP associated with VF loss in eyes treated for proliferative diabetic retinopathy. Further clinical research is warranted to clarify the finding.
Trial Registration


ClinicalTrials.gov identifier: NCT01489189.",2020,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
","['Proliferative Diabetic Retinopathy', '394 eyes enrolled in Protocol S, 234 (59.4%) were targeted for this ancillary study', 'Individuals with eyes with proliferative diabetic retinopathy enrolled in Protocol S were included', 'Data were collected from February 2012 to February 2018']","['Panretinal photocoagulation', 'panretinal photocoagulation (PRP', 'Panretinal Photocoagulation or Ranibizumab', 'Panretinal photocoagulation or intravitreous injections of 0.5-mg ranibizumab', 'ranibizumab', 'peripheral visual field (VF']","['total point score', 'mean (SD) change in total point score', 'Visual Field Changes', 'Main Outcomes and Measures\n\n\nMean change in total point score on VF testing', '5-year mean change in total point score', 'Diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0730064', 'cui_str': 'Scatter retinal laser photocoagulation'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042826', 'cui_str': 'Visual Fields'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}]",,0.0737913,"No association was found between change in point score and the number of ranibizumab injections during the previous year (-9 per injection [95% CI, -22 to 3]).
","[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Johnson', 'Affiliation': 'Visual Field Reading Center, University of Iowa, Iowa City.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Baker', 'Affiliation': 'Paducah Retinal Center, Paducah, Kentucky.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Gardner', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor.'}, {'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Pieramici', 'Affiliation': 'California Retina Consultants, Santa Barbara.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Stockdale', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Beetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5939']
514,31577341,Efficacy and Safety of Oral Janus Kinase 1 Inhibitor Abrocitinib for Patients With Atopic Dermatitis: A Phase 2 Randomized Clinical Trial.,"Importance


Atopic dermatitis is associated with substantial patient and caregiver burden. Currently available treatments for atopic dermatitis are inadequate or contraindicated for some patients. Abrocitinib (PF-04965842) is an oral Janus kinase 1 selective inhibitor under investigation for the treatment of atopic dermatitis.
Objective


To investigate the efficacy and safety of abrocitinib for patients with moderate to severe atopic dermatitis.
Design, Setting, and Participants


A phase 2b, randomized, double-blinded, placebo-controlled, parallel-group trial was conducted from April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months. Efficacy was assessed in the full analysis set, which was a modified intention-to-treat population that included all patients who received 1 dose or more of the study drug except for 4 patients from 1 site.
Interventions


Participants were randomly assigned 1:1:1:1:1 to receive abrocitinib (200 mg, 100 mg, 30 mg, or 10 mg) or placebo once daily for 12 weeks.
Main Outcomes and Measures


The primary outcome was the proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1) with an improvement from baseline of 2 grades or more at week 12. The secondary outcome was the percentage change from baseline in the Eczema Area and Severity Index at week 12.
Results


Of the 267 participants, 144 were women (mean [SD] age, 40.8 [16.1] years). At week 12, 21 of 48 patients receiving 200 mg of abrocitinib (43.8%; P < .001, 2-sided), 16 of 54 patients receiving 100 mg of abrocitinib (29.6%; P < .001), and 3 of 52 patients receiving placebo (5.8%) achieved grades of clear or almost clear on the Investigator's Global Assessment scale with improvement of 2 grades or more; these rates correspond to maximum effect model-based estimates of 44.5% (95% CI, 26.7%-62.3%) for those receiving 200 mg of abrocitinib, 27.8% (95% CI, 14.8%-40.9%) for those receiving 100 mg of abrocitinib, and 6.3% (95% CI, -0.2% to 12.9%) for those receiving placebo. Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%; P = .009) for those receiving 100 mg of abrocitinib, and 35.2% (90% CI, 24.4%-46.1%) for those receiving placebo. Adverse events were observed in 184 of 267 patients (68.9%); the most frequently reported adverse events (in ≥3 patients in any group) were dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea. Dose-dependent decreases in platelet count were observed but trended upward toward baseline levels after week 4.
Conclusions and Relevance


Once-daily oral abrocitinib was effective and well tolerated for short-term use in adults with moderate to severe atopic dermatitis. Additional trials are necessary to evaluate long-term efficacy and safety.
Trial Registration


ClinicalTrials.gov identifier: NCT02780167.",2019,"Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%;","['adults with moderate to severe atopic dermatitis', 'Patients With Atopic Dermatitis', '267 participants', 'patients with moderate to severe atopic dermatitis', 'April 15, 2016, to April 4, 2017, at 58 centers in Australia, Canada, Germany, Hungary, and the United States among 267 patients 18 to 75 years of age with a clinical diagnosis of moderate to severe atopic dermatitis for 1 year or more and inadequate response or contraindication to topical medications for 4 weeks or more within 12 months', '144 were women (mean [SD] age, 40.8 [16.1] years']","['placebo', 'Oral Janus Kinase 1 Inhibitor Abrocitinib', 'abrocitinib']","['adverse events', 'Adverse events', 'efficacy and safety', 'Efficacy', 'platelet count', 'percentage change from baseline in the Eczema Area and Severity Index', 'Efficacy and Safety', 'dermatitis atopic, upper respiratory tract infection, headache, nausea, and diarrhea', 'Eczema Area and Severity Index', ""Investigator's Global Assessment scale"", ""proportion of patients achieving an Investigator's Global Assessment of clear (0) or almost clear (1""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319689', 'cui_str': 'Sixteen point one'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0169658', 'cui_str': 'Jak1 Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]",144.0,0.596428,"Reductions in the Eczema Area and Severity Index were 82.6% (90% CI, 72.4%-92.8%; P < .001) for those receiving 200 mg of abrocitinib, 59.0% (90% CI, 48.8%-69.3%;","[{'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': 'SKiN Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Seth B', 'Initials': 'SB', 'LastName': 'Forman', 'Affiliation': 'Forward Clinical Trials, Tampa, Florida.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Department of Dermatology, Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Innovative Health Statistics, Pfizer Inc, New York, New York.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Early Clinical Development Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Papacharalambous', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Inflammation and Immunology Research Unit, Pfizer Inc, New York, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.2855']
515,31799993,Prevention of Recurrence After Recovery From a Major Depressive Episode With Antidepressant Medication Alone or in Combination With Cognitive Behavioral Therapy: Phase 2 of a 2-Phase Randomized Clinical Trial.,"Importance


Antidepressant medication (ADM) maintenance treatment is associated with the prevention of depressive recurrence in patients with major depressive disorder (MDD), but whether cognitive behavioral therapy (CBT) treatment is associated with recurrence prevention remains unclear.
Objective


To determine the effects of combining CBT with ADM on the prevention of depressive recurrence when ADMs are withdrawn or maintained after recovery in patients with MDD.
Design, Setting, and Participants


A total of 292 adult outpatients with chronic or recurrent MDD who participated in the second phase of a 2-phase trial. Participants had recovered in the first phase of the trial receiving ADM, either alone or in combination with CBT. The trial was conducted in research clinics in 3 university medical centers in the United States. Patients in phase 2 were randomized to receive maintenance of or withdrawal from ADM and were followed up for 3 years. The first and last patients entered phase 2 in August 2003 and October 2009, respectively. The last patient completed phase 2 in August 2012. Data were analyzed from December 2013 to December 2018.
Interventions


Maintenance of or withdrawal from treatment with ADM.
Main Outcomes and Measures


Recurrence of an MDD episode using longitudinal interval follow-up evaluations; sustained recovery across both phases.
Results


A total of 292 participants (171 women, 121 men; mean [SD] age 45.1 [12.9] years) were included in analyses of depressive recurrence. Maintenance ADM yielded lower rates of recurrence compared with ADM withdrawal regardless of whether patients had achieved recovery in phase 1 with ADM alone (48.5% vs 74.8%; z = -3.16; P = .002; number needed to treat [NNT], 2.8; 95% CI, 1.8-7.0) or ADM plus CBT (48.5% vs 76.7%; z = -3.49; P < .001; NNT, 2.7; 95% CI, 1.9-5.9). Sustained recovery rates differed as a function of phase 2 condition, with maintenance ADM superior to ADM withdrawal (z = 2.90; P = .004; OR, 2.54; 95% CI, 1.37-4.84; NNT, 2.3; 95% CI, 1.5-6.4). Phase 1 condition was not associated with differential rates of sustained recovery (ADM alone vs ADM plus CBT; z = 0.22; P = .83; OR, 1.08; 95% CI, 0.52-2.11; NNT, 26.0; 95% CI, number needed to harm 3.2 to NNT 2.8), nor was there a significant interaction of phase 1 condition and phase 2 condition (z = 0.30; P = .77; OR, 1.14; 95% CI, 0.49-2.88).
Conclusions and Relevance


Maintenance ADM treatment, but not previous exposure to CBT, was associated with reduced rates of depressive recurrence. In previous studies, when CBT has been provided without ADM, CBT has shown a preventive effect on depressive relapse. Whether CBT also has a preventive effect on depressive recurrence, or if adding ADM interferes with any such preventive effect, remains unclear.
Trial Registration


ClinicalTrial.gov identifier: NCT00057577.",2020,"Maintenance vs withdrawal of medication was associated with sustained recovery rates (z = 2.90; P = .004; odds ratio [OR], 2.54; 95% CI, 1.37-4.84; NNT, 2.3; 95% CI, 1.5-6.4).","['292 adult outpatients with chronic or recurrent MDD who had previously participated in phase 1 and had recovered from a chronic or recurrent major depressive episode with antidepressant medication treatment alone or in combination with cognitive behavioral therapy (CBT) in phase 1 participated in a phase 2 trial conducted in research clinics in 3 university medical centers in the United States', 'patients with major depressive disorder (MDD', '292 participants (171 women and 121 men; mean [SD] age, 45.1 [12.9] years', 'patients with MDD']","['CBT', 'cognitive behavioral therapy (CBT', 'Cognitive Behavioral Therapy', 'maintenance or withdrawal of treatment with antidepressant medications', 'CBT with antidepressant medications']","['Measures\n\n\nRecurrence of an MDD episode using longitudinal interval follow-up evaluations and sustained recovery', 'depressive recurrence', 'depressive relapse', 'rates of recurrence', 'sustained recovery rates', 'rates of depressive recurrence', 'Recurrence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes (disorder)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C3469597', 'cui_str': 'Medication treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",292.0,0.0715486,"Maintenance vs withdrawal of medication was associated with sustained recovery rates (z = 2.90; P = .004; odds ratio [OR], 2.54; 95% CI, 1.37-4.84; NNT, 2.3; 95% CI, 1.5-6.4).","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zajecka', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, Illinois.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Amsterdam', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fawcett', 'Affiliation': 'Department of Psychiatry, University of New Mexico, Albuquerque.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry, Rush University, Chicago, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Department of Mathematics and Applied Statistics, West Chester University, West Chester, Pennsylvania.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': 'Department of Psychology, Vanderbilt University, Nashville, Tennessee.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3900']
516,32150750,"Immunogenicity, Safety, and Efficacy of a Standalone Universal Influenza Vaccine, FLU-v, in Healthy Adults: A Randomized Clinical Trial.","Background


FLU-v is a broad-spectrum influenza vaccine that induces antibodies and cell-mediated immunity.
Objective


To compare the safety, immunogenicity, and exploratory efficacy of different formulations and dosing regimens of FLU-v versus placebo.
Design


Randomized, double-blind, placebo-controlled, single-center phase 2b clinical trial. (ClinicalTrials.gov: NCT02962908; EudraCT: 2015-001932-38).
Setting


The Netherlands.
Participants


175 healthy adults aged 18 to 60 years.
Intervention


0.5-mL subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo) (2:2:1:1 ratio).
Measurements


Vaccine-specific cellular responses at days 0, 42, and 180 were assessed via flow cytometry and enzyme-linked immunosorbent assay. Solicited information on adverse events (AEs) was collected for 21 days after vaccination. Unsolicited information on AEs was collected throughout the study.
Results


The AEs with the highest incidence were mild to moderate injection site reactions. The difference between A-FLU-v and A-placebo in the median fold increase in secreted interferon-γ (IFN-γ) was 38.2-fold (95% CI, 4.7- to 69.7-fold; P = 0.001) at day 42 and 25.0-fold (CI, 5.7- to 50.9-fold; P < 0.001) at day 180. The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α), 7.0-fold (CI, 3.5- to 18.0-fold; P < 0.001) for interleukin-2 (IL-2), and 1.7-fold (CI, 0.1- to 4.0-fold; P = 0.004) for CD107a. At day 180, differences were 2.1-fold (CI, 0.0- to 6.0-fold; P = 0.030) for IFN-γ and 5.7-fold (CI, 2.0- to 15.0-fold; P < 0.001) for IL-2, with no difference for TNF-α or CD107a. No differences were seen between NA-FLU-v and NA-placebo.
Limitation


The study was not powered to evaluate vaccine efficacy against influenza infection.
Conclusion


Adjuvanted FLU-v is immunogenic and merits phase 3 development to explore efficacy.
Primary Funding Source


SEEK and the European Commission Directorate-General for Research and Innovation, European Member States within the UNISEC (Universal Influenza Vaccines Secured) project.",2020,"The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α),","['Participants\n\n\n175 healthy adults aged 18 to 60 years', 'Healthy Adults']","['Standalone Universal Influenza Vaccine, FLU', 'Intervention\n\n\n0.5-mL', 'placebo', 'FLU-v versus placebo', 'subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo']","['safety, immunogenicity, and exploratory efficacy', 'Immunogenicity, Safety, and Efficacy', 'adverse events (AEs', 'secreted interferon-γ (IFN-γ']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4505399', 'cui_str': 'Universal Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]",175.0,0.648406,"The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α),","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Dille', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'de Groen', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Oftung', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Hubert G M', 'Initials': 'HGM', 'LastName': 'Niesters', 'Affiliation': 'University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands (H.G.N.).'}, {'ForeName': 'Md Atiqul', 'Initials': 'MA', 'LastName': 'Islam', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands, and Shahjalal University of Science and Technology, Sylhet, Bangladesh (M.A.I.).'}, {'ForeName': 'Lisbeth Meyer', 'Initials': 'LM', 'LastName': 'Næss', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Hungnes', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Nuhoda', 'Initials': 'N', 'LastName': 'Aldarij', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Demi L', 'Initials': 'DL', 'LastName': 'Idema', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Ana Fernandez', 'Initials': 'AF', 'LastName': 'Perez', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Henderik W', 'Initials': 'HW', 'LastName': 'Frijlink', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Groeneveld', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Eelko', 'Initials': 'E', 'LastName': 'Hak', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}]",Annals of internal medicine,['10.7326/M19-0735']
517,31513234,Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial.,"Importance


Vibration has been shown to decrease injection site pain in patients; however, to date, this effect has not been assessed for patients who catastrophize pain (ie, patients who anticipate a higher pain level). The anticipation of a pain score greater than 4 on the 11-point Numeric Rating Scale (NRS) has been associated with an increase in a patient's perception of procedural pain.
Objective


To assess the efficacy of vibration during cutaneous anesthetic injection for dermatologic surgery for patients who catastrophize pain (NRS score >4) and patients who do not (NRS score ≤4).
Design, Setting, and Participants


Randomized, parallel-group clinical trial from June 19 to September 4, 2018, at a tertiary dermatologic surgery clinic among 87 adults undergoing cutaneous cancer removal surgery. Patients completed a preprocedural questionnaire detailing their baseline pain, anticipated pain, and drug use. Analysis was performed on an intent-to-treat basis.
Interventions


Use of a vibratory anesthetic device (VAD) on the treatment site prior to anesthetic injection in the on (VAD ON) or off (VAD OFF) mode.
Main Outcomes and Measures


Pain was reported using the 11-point NRS (where 0 indicates no pain and 11 indicates the worst pain imaginable). A minimum clinically important difference of 22% or more and a substantial clinically important difference of 57% or more were used to assess the efficacy of vibration in patient-reported NRS score during anesthetic injection (iNRS score).
Results


A total of 87 patients were included, with 101 unique events reported (among the unique events, 37 were reported in women and 64 were reported in men; mean [SD] age, 66.0 [11.3] years). The mean (confidence level [CL]) iNRS score for patients who catastrophized pain was 2.27 (0.66) compared with 1.44 (0.39) for patients who did not (P = .03). A 38.9% decrease in mean (CL) iNRS score was reported with VAD ON compared with VAD OFF in all participants (1.24 [0.38] vs 2.04 [0.54]). Patients who catastrophized pain reported a 25.5% decrease in mean (CL) iNRS score with VAD ON vs VAD OFF (1.91 [0.99] vs 2.57 [0.98]), and patients who did not reported a 79.4% decrease (1.02 [0.40] vs 1.84 [0.66]). VAD ON was the only statistically significant variable to affect iNRS score (F statistic, 2.741; P = .03).
Conclusions and Relevance


This trial demonstrates that those who catastrophize pain prior to a procedure report a higher perceived level of pain. The application of vibration during local anesthetic injection resulted in a minimum clinically important difference in pain level for patients who catastrophize pain and a substantial clinically important difference in pain level for patients who do not.
Level of Evidence


2.
Trial Registration


ClinicalTrials.gov identifier: NCT03467685.",2019,"The application of vibration during local anesthetic injection resulted in a minimum clinically important difference in pain level for patients who catastrophize pain and a substantial clinically important difference in pain level for patients who do not.
","['Patients', '87 adults undergoing cutaneous cancer removal surgery', 'patients who anticipate a higher pain level', 'Undergoing Cutaneous Cancer Removal Surgery', 'patients who catastrophize pain (NRS score >4) and patients who do not (NRS score', 'mean [SD] age, 66.0 [11.3] years', '87 patients were included, with 101 unique events reported (among the unique events, 37 were reported in women and 64 were reported in men', 'patients who catastrophize pain (ie']","['vibratory anesthetic device (VAD', 'Vibratory Anesthetic Device']","['preprocedural questionnaire detailing their baseline pain, anticipated pain, and drug use', 'pain level', 'mean (CL) iNRS score', '11-point Numeric Rating Scale (NRS', 'Measures\n\n\nPain', 'Pain Anticipation and Subsequent Pain Perception', 'iNRS score', 'mean (confidence level [CL]) iNRS score', 'level of pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",87.0,0.389978,"The application of vibration during local anesthetic injection resulted in a minimum clinically important difference in pain level for patients who catastrophize pain and a substantial clinically important difference in pain level for patients who do not.
","[{'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Govas', 'Affiliation': 'Department of Dermatology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rashek', 'Initials': 'R', 'LastName': 'Kazi', 'Affiliation': 'Department of Dermatology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rachel Marie', 'Initials': 'RM', 'LastName': 'Slaugenhaupt', 'Affiliation': 'Department of Dermatology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Carroll', 'Affiliation': 'Department of Dermatology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA facial plastic surgery,['10.1001/jamafacial.2019.0733']
518,31371287,"Nutrition and Exercise in Critical Illness Trial (NEXIS Trial): a protocol of a multicentred, randomised controlled trial of combined cycle ergometry and amino acid supplementation commenced early during critical illness.","INTRODUCTION


Survivors of critical illness often experience significant morbidities, including muscle weakness and impairments in physical functioning. This muscle weakness is associated with longer duration mechanical ventilation, greater hospital costs and increased postdischarge impairments in physical function, quality of life and survival. Compared with standard of care, the benefits of greater protein intake combined with structured exercise started early after the onset of critical illness remain uncertain. However, the combination of protein supplementation and exercise in other populations has demonstrated positive effects on strength and function. In the present study, we will evaluate the effects of a combination of early implementation of intravenous amino acid supplementation and in-bed cycle ergometry exercise versus a 'usual care' control group in patients with acute respiratory failure requiring mechanical ventilation in an intensive care unit (ICU).
METHODS AND ANALYSIS


In this multicentre, assessor-blinded, randomised controlled trial, we will randomise 142 patients in a 1:1 ratio to usual care (which commonly consists of minimal exercise and under-achievement of guideline-recommended caloric and protein intake goals) versus a combined intravenous amino acid supplementation and in-bed cycle ergometery exercise intervention. We hypothesise that this novel combined intervention will (1) improve physical functioning at hospital discharge; (2) reduce muscle wasting with improved amino acid metabolism and protein synthesis in-hospital and (3) improve patient-reported outcomes and healthcare resource utilisation at 6 months after enrolment. Key cointerventions will be standardised. In-hospital outcome assessments will be conducted at baseline, ICU discharge and hospital discharge. An intent-to-treat analysis will be used to analyse all data with additional per-protocol analyses.
ETHICS AND DISSEMINATION


The trial received ethics approval at each institution and enrolment has begun. These results will inform both clinical practice and future research in the area. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via nutritional and rehabilitation-focused electronic education and knowledge translation platforms.
TRIAL REGISTRATION NUMBER


NCT03021902; Pre-results.",2019,"This muscle weakness is associated with longer duration mechanical ventilation, greater hospital costs and increased postdischarge impairments in physical function, quality of life and survival.","['142 patients in a 1:1 ratio to usual care (which commonly consists of minimal exercise and under-achievement of guideline-recommended caloric and protein intake goals) versus a', 'patients with acute respiratory failure requiring mechanical ventilation in an intensive care unit (ICU']","['intravenous amino acid supplementation and in-bed cycle ergometry exercise', 'combined cycle ergometry and amino acid supplementation', 'combined intravenous amino acid supplementation and in-bed cycle ergometery exercise intervention']","['physical function, quality of life and survival', 'muscle wasting with improved amino acid metabolism and protein synthesis in-hospital and (3) improve patient-reported outcomes and healthcare resource utilisation', 'ICU discharge and hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0856558', 'cui_str': 'Muscle wasting (disuse)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",142.0,0.305924,"This muscle weakness is associated with longer duration mechanical ventilation, greater hospital costs and increased postdischarge impairments in physical function, quality of life and survival.","[{'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Critical Care, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Day', 'Affiliation': ""Department of Community Health and Epidemiology and CERU, Queen's Unversity, Kingston, Ontario, Canada.""}, {'ForeName': 'G John', 'Initials': 'GJ', 'LastName': 'Clarke', 'Affiliation': ""Critical Evalulation Research Unit, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Catherine Terri', 'Initials': 'CT', 'LastName': 'Hough', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Pulmonary, Critical Care, Allergy and Immunology Division, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mourtzakis', 'Affiliation': 'University of Waterloo Faculty of Applied Health Sciences, Waterloo, Ontario, Canada.'}, {'ForeName': 'Nicolaas', 'Initials': 'N', 'LastName': 'Deutz', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, Texas, USA.'}, {'ForeName': 'Dale M', 'Initials': 'DM', 'LastName': 'Needham', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, John Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Stapleton', 'Affiliation': 'Pulmonary and Critical Care, University of Vermont, Burlington, Vermont, USA.'}]",BMJ open,['10.1136/bmjopen-2018-027893']
519,30765762,Bushen Yijing Fang Reduces Fall Risk in Late Postmenopausal Women with Osteopenia: A Randomized Double-blind and Placebo-controlled Trial.,"Falls in late postmenopausal women with osteopenia usually cause fractures with severe consequences. This 36-month randomized, double-blind and placebo-controlled trial with a 10-year observational follow-up study aimed to investigate the long-term effect of herbal formula Bushen Yijing Fang (BSYJF) on fall risk in the late postmenopausal women with osteopenia. 140 late postmenopausal women (Femoral neck T-score, -2.5~-2 SD) were recruited and randomized to orally receive calcium carbonate 300 mg daily with either BSYJF or placebo for 36 months. The effect was further investigated for another 10-year follow-up. During the 36-month administration, there were 12 falls in BSYJF group and 28 falls in placebo group, respectively, indicating 64% lower risk of falls (RR 0.36 [95% CI, 0.18 to 0.71]; P = 0.004) in BSYJF group. During the 10-year follow-up, 36% lower fall risk (RR 0.64 [95% CI, 0.46 to 0.89]; P = 0.009) was observed in BSYJF group. No significant difference was found in safety profile between two groups. Thirty-six-month administration of BSYJF reduced fall risk with an increase in bone mass, and its latent effect on fall risk was continually observed in the 10-year follow-up in late postmenopausal women with osteopenia. This clinical trial was registered at Chinese clinical trial registry (ChiCTR-IOR-16008942).",2019,"Thirty-six-month administration of BSYJF reduced fall risk with an increase in bone mass, and its latent effect on fall risk was continually observed in the 10-year follow-up in late postmenopausal women with osteopenia.","['Late Postmenopausal Women with Osteopenia', 'late postmenopausal women with osteopenia', 'late postmenopausal women with osteopenia usually cause fractures with severe consequences', '140 late postmenopausal women (Femoral neck T-score, -2.5~-2\u2009SD']","['Bushen Yijing Fang', 'herbal formula Bushen Yijing Fang (BSYJF', 'placebo', 'Placebo', 'BSYJF', 'calcium carbonate 300\u2009mg daily with either BSYJF or placebo']","['bone mass', 'risk of falls', 'Fall Risk', 'fall risk', 'safety profile']","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C3854607', 'cui_str': 'T score'}]","[{'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0984378', 'cui_str': 'Calcium Carbonate 300 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.507256,"Thirty-six-month administration of BSYJF reduced fall risk with an increase in bone mass, and its latent effect on fall risk was continually observed in the 10-year follow-up in late postmenopausal women with osteopenia.","[{'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Xuezong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Zong-Kang', 'Initials': 'ZK', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Baosheng', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Dang', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wanzhong', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Preparation Center of Traditional Chinese Medicine, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Institute of Orthopaedics and Traumatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'Institute of Orthopaedics and Traumatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Institute of Orthopaedics and Traumatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Daogang', 'Initials': 'D', 'LastName': 'Guan', 'Affiliation': 'Institute of Integrated Bioinformedicine and Translational Science, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Xiaohao', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Zhenjian', 'Initials': 'Z', 'LastName': 'Zhuo', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Zhixiu', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Lidan', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Zhaoxiang', 'Initials': 'Z', 'LastName': 'Bian', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.'}, {'ForeName': 'Yinyu', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Bao-Ting', 'Initials': 'BT', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China. zhangbaoting@cuhk.edu.hk.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. zhangge@hkbu.edu.hk.'}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Lu', 'Affiliation': 'Institute for Advancing Translational Medicine in Bone & Joint Diseases, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China. aipinglu@hkbu.edu.hk.'}]",Scientific reports,['10.1038/s41598-018-38335-3']
520,31973579,Oxidative Stress Biomarker Decreased in Preterm Neonates Treated With Kangaroo Mother Care.,"OBJECTIVE


Due to physiological and metabolic immaturity, prematurely born infants are at increased risk because of maternal separation in many neonatal intensive care units (NICUs). The stress induced from maternal-infant separation can lead to well-documented short-term physiologic instability and potentially lifelong neurological, sociological, or psychological sequelae. Based on previous studies of kangaroo mother care (KMC) that demonstrated improvement in physiologic parameters, we examined the impact of KMC on physiologic measures of stress (abdominal temperature, heart rate, oxygen saturation, perfusion index, near-infrared spectrometry), oxidative stress, and energy utilization/conservation in preterm infants.
METHODS


In this randomized, stratified study of premature neonates, we compared the effects on urinary concentrations of biomarkers of energy utilization and oxidative stress of 1 hr of KMC versus incubator care on Day 3 of life in intervention-group babies ( n  = 26) and control-group babies ( n  = 25), respectively. On Day 4, both groups received 1 hr of KMC. Urinary samples were collected 3 hr before and 3 hr after intervention/incubator care on both days. Energy utilization was assessed by measures of adenosine triphosphate (ATP) degradation (i.e., hypoxanthine, xanthine, and uric acid). Oxidative stress was assessed using urinary allantoin. Mixed-models analysis was used to assess differences in purine/allantoin.
RESULTS


Mean allantoin levels over Days 3 and 4 were significantly lower in the KMC group than in the control group ( p  = .026).
CONCLUSIONS


Results provide preliminary evidence that KMC reduces neonatal oxidative stress processes and that urinary allantoin could serve as an effective noninvasive marker for future studies.",2020,"Mean allantoin levels over Days 3 and 4 were significantly lower in the KMC group than in the control group ( p  = .026).
","['Preterm Neonates', 'premature neonates', 'intervention-group babies ( n  = 26) and control-group babies ( n  = 25), respectively', 'preterm infants']","['kangaroo mother care (KMC', 'KMC versus incubator care', 'KMC']","['Oxidative stress', 'adenosine triphosphate (ATP) degradation (i.e., hypoxanthine, xanthine, and uric acid', 'Energy utilization', 'Oxidative Stress Biomarker', 'physiologic measures of stress (abdominal temperature, heart rate, oxygen saturation, perfusion index, near-infrared spectrometry), oxidative stress, and energy utilization/conservation', 'Mean allantoin levels']","[{'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0021178', 'cui_str': 'Incubators'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C3541955', 'cui_str': 'Xanthines'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0497913,"Mean allantoin levels over Days 3 and 4 were significantly lower in the KMC group than in the control group ( p  = .026).
","[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'Hahn School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, School of Medicine, Loma Linda University, Loma, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, Division of Biomedical Engineering Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, School of Medicine, Loma Linda University, Loma, CA, USA.'}, {'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Fry-Bowers', 'Affiliation': 'Hahn School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Barger', 'Affiliation': 'Hahn School of Nursing, University of San Diego, CA, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Bahjri', 'Affiliation': 'School of Pharmacy, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, School of Medicine, Loma Linda University, Loma, CA, USA.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, Division of Biochemistry, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Biological research for nursing,['10.1177/1099800419900231']
521,32046311,High Intensity Interval Training Does Not Have Compensatory Effects on Physical Activity Levels in Older Adults.,"BACKGROUND


Exercise has beneficial effects on older adults, but controversy surrounds the purported ""compensatory effects"" that training may have on total daily physical activity and energy expenditure in the elderly. We wanted to determine whether 8 weeks of high-intensity interval training (HIIT) induced such effects on physical activity and energy expenditure in healthy, active older adult men.
METHODS


Twenty-four healthy elderly male volunteers were randomized to two groups. The experimental group performed HIIT (7 × 2 min cycling repetitions, 3 d/w); the control group performed continuous moderate-intensity training (20-30 min cycling, 3 d/w). Physical activity and energy expenditure were measured with a multisensor activity monitor SenseWear Armband Mini.
RESULTS


During HIIT, significant changes were observed in moderate and vigorous physical activity, average daily metabolic equivalents (METs), physical activity level, and activity energy expenditure ( p  < 0.05) but not in total energy expenditure. Sleep and sedentary time, and levels of light physical activity remained constant during the training period.
CONCLUSIONS


The findings suggest that HIIT induced no compensatory effect: HIIT does not adversely affect lifestyle, as it does not reduce daily energy expenditure and/or increase sedentary time.",2020,"During HIIT, significant changes were observed in moderate and vigorous physical activity, average daily metabolic equivalents (METs), physical activity level, and activity energy expenditure ( p  < 0.05) but not in total energy expenditure.","['older adults', 'Older Adults', 'Twenty-four healthy elderly male volunteers', 'healthy, active older adult men']","['high-intensity interval training (HIIT', 'control group performed continuous moderate-intensity training', 'High Intensity Interval Training']","['Physical activity and energy expenditure', 'moderate and vigorous physical activity, average daily metabolic equivalents (METs), physical activity level, and activity energy expenditure', 'Sleep and sedentary time, and levels of light physical activity', 'Physical Activity Levels', 'daily energy expenditure and/or increase sedentary time', 'physical activity and energy expenditure', 'total energy expenditure']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0686754', 'cui_str': 'Well male elder (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}]",24.0,0.0386467,"During HIIT, significant changes were observed in moderate and vigorous physical activity, average daily metabolic equivalents (METs), physical activity level, and activity energy expenditure ( p  < 0.05) but not in total energy expenditure.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruseghini', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, 25123 Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Tam', 'Affiliation': 'Department of Neuroscience, Biomedicine and Movement, School of Exercise and Sport Sciences, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Calabria', 'Affiliation': 'Department of Neuroscience, Biomedicine and Movement, School of Exercise and Sport Sciences, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Milanese', 'Affiliation': 'Department of Neuroscience, Biomedicine and Movement, School of Exercise and Sport Sciences, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Capelli', 'Affiliation': 'Department of Neuroscience, Biomedicine and Movement, School of Exercise and Sport Sciences, University of Verona, 37131 Verona, Italy.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Galvani', 'Affiliation': 'Applied Exercise Physiology Laboratory, Department of Psychology, Università Cattolica del Sacro Cuore, 20162 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17031083']
522,32045077,A randomized controlled trial of a Group psychological intervention to increase locus of control for alcohol consumption among Alcohol-Misusing Short-term (male) Prisoners (GASP).,"BACKGROUND AND AIM


Reducing alcohol misuse by male prisoners is an important global issue. Control of drinking behaviour could be a useful target for intervention in this population, and locus of control could be a causal factor in this. We aimed to assess the effect of a clinical psychologist-facilitated group intervention on male prisoners' locus of control of drinking behaviour.
DESIGN


A two-arm, single-site, open, randomized controlled trial.
SETTING


A category B local training prison in South Wales, housing about 770 mainly sentenced men.
PARTICIPANTS


Prisoners serving less than 2 years who met inclusion criteria for pre-imprisonment alcohol misuse, alone or with drug misuse. A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87, respectively, completed the post-randomization baseline interview and 68 and 60 completed a second interview approximately 4 weeks later, respectively, after intervention or treatment as usual (TAU) alone.
INTERVENTION


Nine clinical psychologist-facilitated groups in the prison over 3 weeks. Range of participants per session was one to seven, with three to five most usual.
MEASURES


The primary outcome was locus of control of behaviour (LCB); secondary outcomes included mental state generally (comprehensive psychiatric rating scale/CPRS) and specifically (Beck Depression Inventory/BDI). An integral process evaluation was conducted.
FINDINGS


LCB scores decreased during the study, but without significant intervention effect [-1.7, 95% confidence interval (CI) = -5.1 to 1.6, P = 0.329]. Change among completers in the control group was from a mean score of 37.4 [standard deviation (SD) = 10.0] to 33.7[SD = 11.7] and in the intervention group from 37.4 (SD = 11.6) to 31.9 (SD = 11.8). Secondary outcomes, including change in mental state, did not differ between arms, but 686 (64%) sessions were lost, most because of 'prison issues'.
CONCLUSIONS


A clinical psychologist-facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre-imprisonment alcohol misuse serving less than 2 years in a South Wales prison. The study proved coterminous, however, with 40% prison staff cuts which seem likely to have contributed to the high loss of group sessions and possibly overwhelmed any treatment effect. Intervention completion failures, previously cited as harmful, had no effect here, so the trial should be repeated when the prison climate improves.",2020,"CONCLUSIONS


A clinical psychologist-facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre-imprisonment alcohol misuse serving under two years in a South Wales prison.","['Prisoners serving under two years who met inclusion criteria for pre-imprisonment alcohol misuse, alone or with drug misuse', 'A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87 respectively completed the', 'men with pre-imprisonment alcohol misuse serving under two years in a South Wales prison', ""male prisoners' locus of control of drinking behaviour"", 'male prisoners', 'Alcohol-misusing Short-term (male) Prisoners (GASP', 'A category B, local training prison in South Wales, housing nearly 800 mostly sentenced men']","['Group psychological intervention', 'post-randomisation baseline interview and 68 and 60 completed a second interview about 4 weeks later, respectively after intervention or treatment as usual (TAU) alone', 'clinical psychologist-facilitated group intervention']","['change in mental state', 'LCB scores', 'sense of control of drinking behaviour', 'Locus of Control of Behaviour (LCB); secondary outcomes included mental state generally (Comprehensive Psychiatric Rating Scale/CPRS) and specifically (Beck Depression Inventory/BDI']","[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4476470', 'cui_str': 'Drug Misuse'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237412', 'cui_str': 'Clinical psychologist (occupation)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021783', 'cui_str': 'Sense of Control'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0023953', 'cui_str': 'Locus of Control'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",,0.109688,"CONCLUSIONS


A clinical psychologist-facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre-imprisonment alcohol misuse serving under two years in a South Wales prison.","[{'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Taylor', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Playle', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Bezeczky', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'John-Evans', 'Affiliation': 'Division of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Polyxeni', 'Initials': 'P', 'LastName': 'Dimitropoulou', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McNamara', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Moriarty', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Zelda', 'Initials': 'Z', 'LastName': 'Summers', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bagshaw', 'Affiliation': 'Abertawe Bro Morgannwg University Health Board, Port Talbot, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.15006']
523,32091536,Association of Black Race With Early Recurrence After Minor Ischemic Stroke or Transient Ischemic Attack: Secondary Analysis of the POINT Randomized Clinical Trial.,"Importance


Stroke incidence is higher among black than white individuals in the United States. It is unclear whether black individuals have a higher risk of stroke recurrence after a minor ischemic stroke or transient ischemic attack (TIA), a high-risk setting in which focused preventive efforts can be effective.
Objective


To examine the association between black race and early ischemic stroke recurrence.
Design, Setting, and Participants


This cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017. The trial enrolled 4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4). For this analysis, we excluded 598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data.
Main Outcomes and Measures


The primary outcome for this analysis was ischemic stroke within 90 days after randomization. Covariates included age, sex, Hispanic ethnicity, study assignment to take clopidogrel vs placebo, index stroke vs TIA, vascular risk factors, statin use, study drug adherence, and index event etiological subtype.
Results


Among 4044 patients included in the analysis, 918 (22.7%) were black. In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3). Findings were similar in subgroup analyses and in analyses limited to sites that enrolled black patients.
Conclusions and Relevance


Among US participants in the POINT trial, black individuals faced a higher risk of early stroke recurrence after a minor ischemic stroke or TIA. Our findings support research into black-white racial differences in the underlying mechanisms of recurrent stroke. In the meantime, extra effort should be made to ensure that black patients have access to proven secondary prevention measures.
Trial Registration


clinicaltrials.gov Identifier: NCT00991029.",2020,"In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3).","['4044 patients included in the analysis, 918 (22.7%) were black', '598 patients enrolled outside the United States and 239 US patients with missing race/ethnicity data', 'Participants\n\n\nThis cohort study analyzed data from the Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial conducted at 269 sites from May 28, 2010, to December 19, 2017', '4881 adults within 12 hours of onset of a minor ischemic stroke (National Institutes of Health Stroke Scale score, 0-3) or high-risk TIA (ABCD2 score, ≥4']",['clopidogrel vs placebo'],"['risk of early stroke recurrence', 'ischemic stroke', 'Black Race']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]",4881.0,0.352948,"In an adjusted Cox model, black race was associated with a higher risk of recurrence compared with white race (hazard ratio, 1.6; 95% CI, 1.1-2.3).","[{'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Cenai', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute and Department of Neurology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Dawn O', 'Initials': 'DO', 'LastName': 'Kleindorfer', 'Affiliation': 'Department of Neurology, University of Cincinnati, Ohio.'}, {'ForeName': 'Emily B', 'Initials': 'EB', 'LastName': 'Levitan', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Virginia J', 'Initials': 'VJ', 'LastName': 'Howard', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elsayed Z', 'Initials': 'EZ', 'LastName': 'Soliman', 'Affiliation': 'Epidemiological Cardiology Research Center, Division of Cardiology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dell Medical School, Dean's Office, University of Texas at Austin, Austin.""}]",JAMA neurology,['10.1001/jamaneurol.2020.0010']
524,32157691,Impact of sleep restriction on affective functioning in adolescents with attention-deficit/hyperactivity disorder.,"BACKGROUND


Shortened sleep and affective disturbances are both prevalent in adolescents with attention-deficit/hyperactivity disorder (ADHD), yet the causal link between these domains has not been examined. This study investigated whether shortened sleep duration is causally linked to affective functioning in adolescents with ADHD.
METHODS


Participants were 48 adolescents (75% male) aged 14-17 years with ADHD who successfully completed a three-week sleep protocol using an experimental crossover design. The protocol included a phase stabilization week, followed, in randomized counterbalanced order, by one week of sleep restriction (6.5 hr in bed) and one week of sleep extension (9.5 hr in bed). Sleep was monitored with objective actigraphy, and all participants included in this study obtained ≥1 hr actigraphy-measured sleep duration during extension compared to restriction. Parents and adolescents provided daily ratings of positive and negative affect during the extension and restriction conditions. Ratings of affect, internalizing symptoms, and emotion regulation were collected at laboratory visits conducted at the end of each week.
RESULTS


Both parents and adolescents reported greater depressive symptoms and lower positive affect during restriction compared to extension. Parents also reported greater negative affect and emotion dysregulation among adolescents during sleep restriction than extension. No effects were found for parent- or adolescent-reported anxiety symptoms or for adolescent-reported emotion regulation or negative affect.
CONCLUSIONS


Findings from this study provide the first evidence that shortened sleep duration is a causal contributor to the affect and mood disturbances frequently experienced by adolescents with ADHD, particularly as observed by parents. Targeting sleep may be important to reduce affective disturbances in adolescents with ADHD.",2020,"No effects were found for parent- or adolescent-reported anxiety symptoms or for adolescent-reported emotion regulation or negative affect.
","['adolescents with ADHD', 'Participants were 48 adolescents (75% male) aged 14-17\xa0years with ADHD who successfully completed a three-week sleep protocol using an experimental crossover design', 'adolescents with attention-deficit/hyperactivity disorder', 'adolescents with attention-deficit/hyperactivity disorder (ADHD']",['sleep restriction'],"['parent- or adolescent-reported anxiety symptoms', 'Sleep', 'emotion regulation or negative affect', 'Ratings of affect, internalizing symptoms, and emotion regulation', 'depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4082109', 'cui_str': 'Three weeks'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0462368,"No effects were found for parent- or adolescent-reported anxiety symptoms or for adolescent-reported emotion regulation or negative affect.
","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Becker', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Tamm', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffery N', 'Initials': 'JN', 'LastName': 'Epstein', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13235']
525,30707847,"""But Dr Google said…"" - Training medical students how to communicate with E-patients.","Purpose:  Patients who have access to information online may feel empowered and also confront their physicians with more detailed questions. Medical students are not well-prepared for dealing with so-called ""e-patients."" We created a teaching module to deal with this, and evaluate its effectiveness. Method:  Senior medical students had to manage encounters with standardized patients (SPE) in a cross-over design. They received blended-learning teaching on e-patients and a control intervention according to their randomization group (EI/LI = early/late intervention). Each SPE was rated by two blinded video raters, the SP and the student. Results:  N = 46 students could be included. After the intervention, each group (EI, LI) significantly improved their competency in dealing with e-patients as judged by expert video raters (EI:  M T0  = 9.75 (2.51) versus  M T1  = 16.60 (2.80); LI:  M T0  = 8.70 (2.14) versus  M T2  = 15.20 (2.84); both p < 0.001) and SP (EI:  M T0  = 24.13 (4.83) versus  M T1  = 26.52 (3.06); LI:  M T0  = 23.37 (3.10) versus  M T2  = 27.47 (4.38); both p < 0.001). Students' rating showed a similar non-significant trend. Conclusions:  Students, SP and expert video raters determined that blended-learning teaching can improve students' competencies when dealing with e-patients. Within the study period, this effect was lasting; however, further studies should look at long-term outcomes.",2019,"CONCLUSIONS


Students, SP and expert video raters determined that blended-learning teaching can improve students' competencies when dealing with e-patients.","['Senior medical students had to manage encounters with standardized patients (SPE) in a cross-over design', 'N\u2009=\u200946 students']",['blended-learning teaching on e-patients and a control intervention according to their randomization group (EI/LI\u2009=\u2009early/late intervention'],[],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",[],46.0,0.0438779,"CONCLUSIONS


Students, SP and expert video raters determined that blended-learning teaching can improve students' competencies when dealing with e-patients.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Herrmann-Werner', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Loda', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Keifenheim', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Erschens', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Mölbert', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nikendei', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Medical Department VI/Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Masters', 'Affiliation': 'Medical Education & Informatics Unit, College of Medicine & Health Sciences SQU, Alkoudh, Sultanate of Oman.'}]",Medical teacher,['10.1080/0142159X.2018.1555639']
526,32069067,"Efficacy of  Insulclock  in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial.","Insulclock ®  is an electronic device designed to improve treatment adherence and insulin injection tracking. This randomized, single-center, pilot study assessed the clinical impact of  Insulclock  on glycemic control and variability, treatment adherence, and satisfaction in patients with uncontrolled type 1 diabetes mellitus (T1DM). We also compared these outcomes between the Active and Masked groups (with or without receiving reminders and app alerts). Sixteen patients completed the study: 10 in the Active group and 6 in the Masked group. Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL [1.5 mmol/L];  P  = 0.013), glucose standard deviation (-14.4 mg/dL [0.8 mmol/L];  P  = 0.003), and time above range (-12.5%;  P  = 0.0026), and an increase in time in range (TIR) (+7%;  P  = 0.038) in the overall population. The use of app information and alerts in the Active group was associated with an increase in TIR (+8%;  P  = 0.026). We observed a -3.9 ( P  = 0.1352) and -5.4 ( P  = 0.032) reduction per month in the number of missed and mistimed insulin doses in the overall population, respectively. Most of the items of the Insulin Treatment Satisfaction Questionnaire (ITSQ) improved after 4 weeks of  Insulclock  use. This pilot study points out an improvement in glycemic levels, adherence, and satisfaction in T1DM patients, supporting the development of clinical trials powered to confirm these effects.",2020,Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL,"['patients with uncontrolled Type 1 diabetes mellitus (T1DM', 'patients with poorly controlled type 1 diabetes mellitus', 'Sixteen patients completed the study: ten in the Active group and six in the Masked group']",['Insulclock'],"['time above range (TAR', 'glucose standard deviation (SD', 'mean glucose', 'TIR', 'time in range (TIR', 'Insulin Treatment Satisfaction Questionnaire (ITSQ', 'glycemic levels, adherence and satisfaction', 'glycemic control and variability, treatment adherence and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3887664', 'cui_str': 'Tars, topical antipsoriatics'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]",16.0,0.0771619,Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gomez-Peralta', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Abreu', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gomez-Rodriguez', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Cruz-Bravo', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'María-Sanchez', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Poza', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ruiz-Valdepeñas', 'Affiliation': 'Research and Development Unit, Insulcloud S.L. (B87131454), Madrid, Spain.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0427']
527,31154316,Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments (I-SOCIALISE): study protocol.,"INTRODUCTION


Social skills training interventions for children with autism spectrum disorder (ASD) typically focus on a skills deficit model rather than building on existing skills or encouraging the child to seek their own solutions. LEGO-based therapy is a child-oriented intervention to help improve social interactional skills and reduce isolation. The therapy is designed for school-age children with ASD and uses group-based play in a school setting to encourage peer relationships and social learning. Despite the reported potential benefits of LEGO-based therapy in a prior randomised controlled trial (RCT) and its adoption by many schools, the evidence to support its effectiveness on the social and emotional well-being of children with ASD is limited and includes no assessment of cost-effectiveness.
METHODS AND ANALYSIS


This multicentre, pragmatic, cluster RCT will randomise 240 participants (aged 7-15 years) with a clinical diagnosis of ASD to receive usual care or LEGO-based therapy with usual care. Cluster randomisation will be conducted on a school level, randomising each school as opposed to each individual child within a school. All prospective participants will be screened for eligibility before assenting to the study (with parents giving informed consent on behalf of their child). All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes. The primary outcome measure is the social skills subscale of the Social Skills Improvement System completed by a teacher or teaching assistant associated with participating children at the 20-week follow-up time point.
ETHICS AND DISSEMINATION


Ethics approval has been obtained via the University of York Research Ethics Committee. The results of the trial will be submitted for publication in a peer-reviewed journal and will be disseminated to participating families, education practitioners and the third sector including voluntary and community organisations.
TRIAL REGISTRATION NUMBER


ISRCTN64852382; Pre-results.",2019,"All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes.","['children with autism spectrum disorder (ASD', '240 participants (aged 7-15 years) with a clinical diagnosis of ASD to receive', 'school-age children with ASD', 'children with Autism taking part in LEGO-based therapy clubs In School Environments', 'All prospective participants will be screened for eligibility before assenting to the study (with parents giving informed consent on behalf of their child']","['Social skills training interventions', 'usual care or LEGO-based therapy with usual care', 'LEGO-based therapy']","['social skills subscale of the Social Skills Improvement System completed by a teacher or teaching assistant associated with participating children at the 20-week follow-up time point', 'social interactional skills']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",240.0,0.0518253,"All participants will be followed up at 20 and 52 weeks after randomisation to assess for social, emotional and behavioural changes.","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Varley', 'Affiliation': 'COMIC, Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'ScHARR, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Marshall', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Biggs', 'Affiliation': 'Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chater', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Coates', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Gomez de la Cuesta', 'Affiliation': 'Cambridgeshire Community Services NHS Trust, Cambridge, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kingsley', 'Affiliation': 'Leeds and York Partnership NHS Foundation Trust, York, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Le Couteur', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'McKelvey', 'Affiliation': 'City of York Council, York, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Shephard', 'Affiliation': 'Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Teare', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030471']
528,31870666,Digital Management of Hypertension Improves Systolic Blood Pressure Variability.,"BACKGROUND


Higher systolic blood pressure variability has been shown to be a better predictor of all-cause and cardiovascular disease mortality, stroke, and cardiac disease compared with average systolic blood pressure.
METHODS


We evaluated the impact of a digital hypertension program on systolic blood pressure variability in 803 consecutive patients with long-standing hypertension who had been under the care of a primary care physician for a minimum of 12 months prior to enrollment (mean 4.7 years). Blood pressure readings were transmitted directly from home using a digitally connected blood pressure unit. Medication adjustments and lifestyle coaching was performed virtually via a dedicated team of pharmacists and health coaches. Systolic blood pressure variability was grouped by quartile and measured using the standard deviation (SD) of all systolic blood pressure values per individual.
RESULTS


The mean age was 67 ± 12 years, 41% were male, submitting 3.3 ± 3.7 blood pressures per week. Under usual care, only 30% of patients were in the lowest-risk quartile, and 21% of patients were in the highest risk. After 24 months, the mean systolic blood pressure variability progressively fell from 12.8 ± 4.3 mm Hg to 9.9 ± 5.1 mm Hg (P <0.0001) with 57% of patients achieving the lowest-risk quartile.
CONCLUSIONS


The majority of patients with hypertension under usual care have elevated systolic blood pressure variability exposing them to higher risk of cardiovascular disease events. Digital management of hypertension that includes weekly submission of home readings leads to improvement in average systolic blood pressure as well as systolic blood pressure variability over time, which should improve cardiovascular prognosis.",2020,"After 24 months, the mean systolic blood pressure variability progressively fell from 12.8±4.3 mmHg to 9.9±5.1 mmHg (p<0.0001) with 57% of patients achieving the lowest risk quartile.
","['The mean age was 67±12 years, 41% were male, submitting 3.3±3.7 blood pressures per week', '803 consecutive patients with long-standing hypertension who had been under the care of a primary care physician for a minimum of 12 months prior to enrollment (mean 4.7 years']",['digital hypertension program'],"['Systolic Blood Pressure Variability', 'systolic blood pressure variability', 'average systolic blood pressure', 'mean systolic blood pressure variability', 'systolic blood pressure values per individual', 'Blood pressure readings', 'Systolic blood pressure variability']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",803.0,0.0248688,"After 24 months, the mean systolic blood pressure variability progressively fell from 12.8±4.3 mmHg to 9.9±5.1 mmHg (p<0.0001) with 57% of patients achieving the lowest risk quartile.
","[{'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Milani', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La; Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, La. Electronic address: rmilani@ochsner.org.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Wilt', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Milani', 'Affiliation': 'Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bober', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La; Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, La.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Malamud', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Entwisle', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Lavie', 'Affiliation': 'Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, La.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.10.043']
529,31320354,Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.,"INTRODUCTION


Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy.
METHODS AND ANALYSIS


The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment.
ETHICS AND DISSEMINATION


The trial design and protocol have received national ethical approval (12/YH/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns.
TRIAL REGISTRATION NUMBER


NCT01819662.",2019,"INTRODUCTION


Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life.","['1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months', 'pacemaker patients for heart failure']","['transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up', 'pacemaker therapy and medical therapy']","['external validation of our risk stratification model to predict onset of heart failure and quality of life assessment', 'time to all-cause mortality or heart failure hospitalisation']","[{'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography (procedure)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",1200.0,0.200593,"INTRODUCTION


Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life.","[{'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Paton', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gierula', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Haqeel A', 'Initials': 'HA', 'LastName': 'Jamil', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Lowry', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Byrom', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Gillott', 'Affiliation': 'Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Chumun', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Cubbon', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Stocken', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Kearney', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Klaus K', 'Initials': 'KK', 'LastName': 'Witte', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.'}]",BMJ open,['10.1136/bmjopen-2018-028613']
530,32167001,A single administration of 'microbial' D-alanine to healthy volunteers augments reaction to negative emotions: A comparison with D-serine.,"BACKGROUND


Activation of the glutamate N-methyl-D-aspartate receptor with its co-agonist D-serine has been shown to improve subjective mood in healthy volunteers. D-alanine is another potent N-methyl-D-aspartate receptor co-agonist which arises from the natural breakdown of host gut microbes, and is predominantly sequestered in the pituitary. This may suggest that D-alanine influences the neuroendocrine stress response which may then impact on emotion.
AIMS


The current study explored the effects of D-serine and D-alanine on emotional processing, cognition and the levels of the stress hormone cortisol in healthy volunteers.
METHODS


In a double-blind, placebo-controlled randomised study, participants ( n =63) received a single oral dose of either D-serine, D-alanine (60 mg/kg) or placebo and then performed the Emotional Test Battery and N-back task (two hours post-administration) and provided saliva samples at fixed intervals.
RESULTS


Subjects administered with D-alanine were faster at identifying facial expressions of fear, surprise and anger, and at categorising negative self-referential words. Participants on D-alanine also showed a trend to recall more words than placebo in a memory task. D-serine did not have any meaningful effects in any of the tasks. Neither amino acid had a significant effect on salivary cortisol or working memory.
CONCLUSION


This study is the first to suggest that D-alanine can modulate emotional cognitive processing after a single dose. The lack of findings for D-serine nevertheless contrasts a previous study, emphasising a need for further investigation to clarify discrepancies. A better understanding of the physiological actions of D-amino acids would be beneficial in evaluating their therapeutic potential.",2020,"RESULTS


Subjects administered with D-alanine were faster at identifying facial expressions of fear, surprise and anger, and at categorising negative self-referential words.","['participants ( n =63', 'healthy volunteers', 'healthy volunteers augments reaction to negative emotions']","['single oral dose of either D-serine, D-alanine', 'placebo', 'D-serine and D-alanine', 'D-alanine', ""microbial' D-alanine""]","['facial expressions of fear, surprise and anger', 'emotional processing, cognition and the levels of the stress hormone cortisol', 'emotional cognitive processing', 'salivary cortisol or working memory']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1880218', 'cui_str': 'serine, D-'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015457', 'cui_str': 'Facial Expression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]",,0.178192,"RESULTS


Subjects administered with D-alanine were faster at identifying facial expressions of fear, surprise and anger, and at categorising negative self-referential words.","[{'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Forsyth', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mia A', 'Initials': 'MA', 'LastName': 'Thomaidou', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Condon', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Philip Wj', 'Initials': 'PW', 'LastName': 'Burnet', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120908904']
531,32011642,Effectiveness of Intrapleural Tissue Plasminogen Activator and Dornase Alfa vs Tissue Plasminogen Activator Alone in Children with Pleural Empyema: A Randomized Clinical Trial.,"Importance


Clinical guidelines recommend that children with pleural empyema be treated with chest tube insertion and intrapleural fibrinolytics. The addition of dornase alfa (DNase) has been reported to improve outcomes in adults but remains unproven in children.
Objective


To determine if intrapleural tissue plasminogen activator (tPA) and DNase is more effective than tPA and placebo at reducing hospital length of stay in children with pleural empyema.
Design, Setting, and Participants


This multicenter, parallel-group, placebo-controlled, superiority randomized clinical trial included children diagnosed as having pleural empyema requiring drainage aged 6 months to 18 years treated at 6 tertiary Canadian children's hospitals. A total of 379 children were assessed for eligibility; 281 were excluded and 98 were randomized. One child was excluded after randomization for not meeting the inclusion criteria. Data were collected from March 4, 2013, to December 13, 2017.
Interventions


Participants underwent chest tube insertion and 3 daily administrations of intrapleural tPA, 4 mg, followed by DNase, 5 mg (intervention group), or 5 mL of normal saline (placebo; control group). Participants, families, clinical staff, and members of the study team were blinded to allocation.
Main Outcomes and Measures


The primary outcome was hospital length of stay from chest tube insertion to discharge. Secondary outcomes included time to meeting discharge criteria, time to chest tube removal, mean fever duration, additional pleural drainage procedures, hospital readmissions, and total health care cost.
Results


Of the 97 analyzed children with pleural empyema, 52 (54%) were male, and the mean (SD) age was 5.1 (3.6) years. A total of 49 children were randomized to tPA and DNase and 48 were randomized to tPA and placebo. Treatment with tPA and DNase was not associated with decreased hospital length of stay compared with tPA and placebo (mean [SD] length of stay, 9.0 [4.9] vs 9.1 [5.3] days; mean difference, -0.1 days; 95% CI, -2.0 to 2.1; P = .96). Similarly, no significant differences were observed for any of the secondary outcomes. Of the 14 adverse events in the tPA and DNase group, 6 (43%) were serious; of the 21 adverse events in the tPA and placebo group, 8 (38%) were serious. There were no deaths.
Conclusions and Relevance


The addition of DNase to intrapleural tPA for children with pleural empyema had no effect on hospital length of stay or other outcomes compared with tPA with placebo. Clinical practice guidelines should continue to support the use of chest tube insertion and intrapleural fibrinolytics alone as first-line treatment for pediatric empyema.
Trial Registration


ClinicalTrials.gov identifier: NCT01717742.",2020,"Treatment with tPA and DNase was not associated with decreased hospital length of stay compared with tPA and placebo (mean [SD] length of stay, 9.0 [4.9] vs 9.1","['A total of 379 children were assessed for eligibility; 281 were excluded and 98 were randomized', 'adults but remains unproven in children', '97 analyzed children with pleural empyema, 52 (54%) were male, and the mean (SD) age was 5.1 (3.6) years', ""children diagnosed as having pleural empyema requiring drainage aged 6 months to 18 years treated at 6 tertiary Canadian children's hospitals"", '49 children', 'children with pleural empyema', 'Children with Pleural Empyema']","['intrapleural tissue plasminogen activator (tPA) and DNase', 'tPA and DNase', 'placebo', 'intrapleural tPA, 4 mg, followed by DNase, 5 mg (intervention group), or 5 mL of normal saline (placebo', 'tPA and placebo', 'Intrapleural Tissue Plasminogen Activator and Dornase Alfa vs Tissue Plasminogen Activator Alone']","['hospital length of stay from chest tube insertion to discharge', 'time to meeting discharge criteria, time to chest tube removal, mean fever duration, additional pleural drainage procedures, hospital readmissions, and total health care cost', 'hospital length of stay']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456370', 'cui_str': 'Unproven (qualifier value)'}, {'cui': 'C0014013', 'cui_str': 'Pyothorax'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0011522', 'cui_str': 'Deoxyribonucleases'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1135662', 'cui_str': 'dornase alfa (desoxyribonuclease)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0189476', 'cui_str': 'Tube thoracostomy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2224175', 'cui_str': 'Chest tube removal'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",379.0,0.415324,"Treatment with tPA and DNase was not associated with decreased hospital length of stay compared with tPA and placebo (mean [SD] length of stay, 9.0 [4.9] vs 9.1","[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Livingston', 'Affiliation': ""McMaster Children's Hospital, McMaster University, Hamilton, Ontario, Canada.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mahant', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bairbre', 'Initials': 'B', 'LastName': 'Connolly', 'Affiliation': 'Image-Guided Therapy, Department of Diagnostic Imaging, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'MacLusky', 'Affiliation': ""Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Laberge', 'Affiliation': 'Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Giglia', 'Affiliation': ""McMaster Children's Hospital, McMaster University, Hamilton, Ontario, Canada.""}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ""British Columbia's Children's Hospital, Division of Respiratory Medicine, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': ""British Columbia's Children's Hospital, Division of Respiratory Medicine, Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shawyer', 'Affiliation': 'Health Sciences Centre, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Brindle', 'Affiliation': ""Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Parsons', 'Affiliation': ""Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Stoian', 'Affiliation': ""Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'Walton', 'Affiliation': ""McMaster Children's Hospital, McMaster University, Hamilton, Ontario, Canada.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mamdani', 'Affiliation': ""Li Ka Shing Centre for Healthcare Analytics Research and Training, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Loong', 'Affiliation': ""Centre for Excellence in Economic Analysis Research (CLEAR), The HUB Health Research Solutions, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ratjen', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Cohen', 'Affiliation': 'Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5863']
532,32162241,"Safety and tolerability of 6-month supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink in sarcopenic older adults.","AIMS


Safety and tolerability of prolonged supplementation with a vitamin D, calcium and leucine-enriched whey protein medical nutrition drink (WP-MND) was evaluated in sarcopenic older adults.
METHODS


A 13-week double-blinded, randomized, isocaloric placebo-controlled trial (PROVIDE study; n = 380) was extended with a voluntary 13-week open-label extension (OLE). OLE participants were randomized to receive daily 1 or 2 servings of WP-MND (21 g protein, 3 g leucine, 10 µg vitD and 500 mg calcium per serving). Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium were evaluated at week 0, 13 and 26.
RESULTS AND DISCUSSION


In response to the high daily protein intake (median1.5; IQR: 1.3, 1.7 g/kg BW/day), the estimated glomerular filtration rate (eGFR) increased in the test group during the RCT (p = 0.013). The same trend was observed for those participants with moderate chronic kidney disease. During OLE no eGFR change was observed in any of the groups. Serum calcidiol and calcium reached a plateau after 13-week WP-MND supplementation. As expected, PTH significantly changed in the opposite direction, decreasing during RCT in the test group (T vs C: p < 0.001) and during OLE in former control groups. During RCT, 20/366 participants with normal baseline calcidiol reached levels ≥ 100 nmol/L (T: n = 18; C: n = 2) and 6 developed albumin-corrected calcium levels > 2.55 mmol/L (T: n = 3; C: n = 3), without associated adverse events.
CONCLUSION


A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity. The product was overall well tolerated.",2020,A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity.,"['OLE participants', 'study; n\u2009=\u2009380', 'participants with moderate chronic kidney disease', 'sarcopenic older adults']","['enriched whey protein medical nutrition drink (WP-MND', 'voluntary 13-week open-label extension (OLE', 'WP-MND', 'prolonged supplementation with a vitamin D, calcium and leucine', 'vitamin D, calcium and leucine-enriched whey protein medical nutrition drink', 'isocaloric placebo']","['kidney function deterioration nor symptoms of vitamin D or calcium toxicity', 'tolerated', 'Gastro-intestinal tolerability, kidney function and serum levels of calcidiol, parathyroid hormone (PTH) and calcium', 'glomerular filtration rate (eGFR', 'Safety and tolerability', 'eGFR change', 'Serum calcidiol and calcium']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0681013,A 6 months intervention with up to 2 servings of WP-MND did neither result in kidney function deterioration nor symptoms of vitamin D or calcium toxicity.,"[{'ForeName': 'Jürgen M', 'Initials': 'JM', 'LastName': 'Bauer', 'Affiliation': 'Center for Geriatric Medicine, University Heidelberg, Agaplesion Bethanien Krankenhaus Heidelberg, Heidelberg, Germany. Juergen.Bauer@bethanien-heidelberg.de.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mikušová', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Sjors', 'Initials': 'S', 'LastName': 'Verlaan', 'Affiliation': 'Department of Internal Medicine, Section of Gerontology and Geriatrics, VU, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Brandt', 'Affiliation': 'Human Nutrition Research Centre, School of Agriculture, Food and Rural Development, Newcastle University Institute for Ageing, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lorenzo M', 'Initials': 'LM', 'LastName': 'Donini', 'Affiliation': 'Department of Experimental Medicine, Section of Medical Pathophysiology, Endocrinology and Human Nutrition, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Maggio', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Geriatrics, University of Parma, Parma, Italy.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mets', 'Affiliation': 'Frailty in Ageing Research Group (FRIA), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Sander L J', 'Initials': 'SLJ', 'LastName': 'Wijers', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Jossie A', 'Initials': 'JA', 'LastName': 'Garthoff', 'Affiliation': 'Danone Food Safety Center, Utrecht, The Netherlands.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Luiking', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Cornel', 'Initials': 'C', 'LastName': 'Sieber', 'Affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Public Health and Caring Sciences/Clinical Nutrition and Metabolism, Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Aging clinical and experimental research,['10.1007/s40520-020-01519-x']
533,30900550,Electronically delivered interventions to reduce antibiotic prescribing for respiratory infections in primary care: cluster RCT using electronic health records and cohort study.,"BACKGROUND


Unnecessary prescribing of antibiotics in primary care is contributing to the emergence of antimicrobial drug resistance.
OBJECTIVES


To develop and evaluate a multicomponent intervention for antimicrobial stewardship in primary care, and to evaluate the safety of reducing antibiotic prescribing for self-limiting respiratory infections (RTIs).
INTERVENTIONS


A multicomponent intervention, developed as part of this study, including a webinar, monthly reports of general practice-specific data for antibiotic prescribing and decision support tools to inform appropriate antibiotic prescribing.
DESIGN


A parallel-group, cluster randomised controlled trial.
SETTING


The trial was conducted in 79 general practices in the UK Clinical Practice Research Datalink (CPRD).
PARTICIPANTS


All registered patients were included.
MAIN OUTCOME MEASURES


The primary outcome was the rate of antibiotic prescriptions for self-limiting RTIs over the 12-month intervention period.
COHORT STUDY


A separate population-based cohort study was conducted in 610 CPRD general practices that were not exposed to the trial interventions. Data were analysed to evaluate safety outcomes for registered patients with 45.5 million person-years of follow-up from 2005 to 2014.
RESULTS


There were 41 intervention trial arm practices (323,155 patient-years) and 38 control trial arm practices (259,520 patient-years). There were 98.7 antibiotic prescriptions for RTIs per 1000 patient-years in the intervention trial arm (31,907 antibiotic prescriptions) and 107.6 per 1000 patient-years in the control arm (27,923 antibiotic prescriptions) [adjusted antibiotic-prescribing rate ratio (RR) 0.88, 95% confidence interval (CI) 0.78 to 0.99;  p  = 0.040]. There was no evidence of effect in children aged < 15 years (RR 0.96, 95% CI 0.82 to 1.12) or adults aged ≥ 85 years (RR 0.97, 95% CI 0.79 to 1.18). Antibiotic prescribing was reduced in adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year. Analysis of trial data for 12 safety outcomes, including pneumonia and peritonsillar abscess, showed no evidence that these outcomes might be increased as a result of the intervention. The analysis of data from non-trial practices showed that if a general practice with an average list size of 7000 patients reduces the proportion of RTI consultations with antibiotics prescribed by 10%, then 1.1 (95% CI 0.6 to 1.5) more cases of pneumonia per year and 0.9 (95% CI 0.5 to 1.3) more cases of peritonsillar abscesses per decade may be observed. There was no evidence that mastoiditis, empyema, meningitis, intracranial abscess or Lemierre syndrome were more frequent at low-prescribing practices.
LIMITATIONS


The research was based on electronic health records that may not always provide complete data. The number of practices included in the trial was smaller than initially intended.
CONCLUSIONS


This study found evidence that, overall, general practice antibiotic prescribing for RTIs was reduced by this electronically delivered intervention. Antibiotic prescribing rates were reduced for adults aged 15-84 years, but not for children or the senior elderly.
FUTURE WORK


Strategies for antimicrobial stewardship should employ stratified interventions that are tailored to specific age groups. Further research into the safety of reduced antibiotic prescribing is also needed.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN95232781.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 11. See the NIHR Journals Library website for further project information.",2019,"Antibiotic prescribing was reduced in adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year.","['All registered patients were included', 'adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year', 'A separate population-based cohort study was conducted in 610 CPRD general practices that were not exposed to the trial interventions', 'adults aged 15-84 years, but not for children or the senior elderly', 'registered patients with 45.5 million person-years of follow-up from 2005 to 2014', '79 general practices in the UK Clinical Practice Research Datalink (CPRD']",['multicomponent intervention'],"['safety outcomes', 'proportion of RTI consultations', 'Antibiotic prescribing rates', 'mastoiditis, empyema, meningitis, intracranial abscess or Lemierre syndrome', 'pneumonia and peritonsillar abscess', 'rate of antibiotic prescriptions for self-limiting RTIs', 'Antibiotic prescribing']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0444894', 'cui_str': 'CI 40'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0024904', 'cui_str': 'Mastoiditis'}, {'cui': 'C0014009', 'cui_str': 'Empyema'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0021874', 'cui_str': 'Intracranial abscess (disorder)'}, {'cui': 'C0343525', 'cui_str': 'Lemierre Disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0031157', 'cui_str': 'Peritonsillar Abscess'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.254537,"Antibiotic prescribing was reduced in adults aged between 15 and 84 years (RR 0.84, 95% CI 0.75 to 0.95), that is, one antibiotic prescription was avoided for every 62 patients (95% CI 40 to 200 patients) aged 15-84 years per year.","[{'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Gulliford', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Juszczyk', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Soames', 'Affiliation': 'Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDermott', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Kirin', 'Initials': 'K', 'LastName': 'Sultana', 'Affiliation': 'Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Fox', 'Affiliation': 'The Health Centre, Bicester, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care Research Group, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Department of Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Charlton', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23110']
534,31693083,Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial.,"Importance


This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms.
Objective


To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks.
Design, Setting, and Participants


This multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months.
Interventions


Paired right-sided SGB or sham procedures at weeks 0 and 2.
Main Outcomes and Measures


Improvement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori).
Results


Of 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was -12.6 points (95% CI, -15.5 to -9.7 points) for the group receiving SGB treatments, compared with -6.1 points (95% CI, -9.8 to -2.3 points) for those receiving sham treatment (P = .01).
Conclusions and Relevance


In this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct.
Trial Registration


ClinicalTrials.gov identifier: NCT03077919.",2020,To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5,"['Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months', '190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study', 'Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included', 'posttraumatic stress disorder (PTSD) symptoms', '2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers']","['stellate ganglion block (SGB', 'Stellate Ganglion Block Treatment']","['mean CAPS-5 total symptom severity scores', 'site and baseline total symptom severity scores (planned a priori', 'mean (SD) CAPS-5 scores', 'CAPS-5 total symptom severity scores', 'Posttraumatic Stress Disorder Symptoms', 'mean total symptom severity score change', 'mean Clinician-Administered PTSD Scale for DSM-5', 'CAPS-5) total symptom severity scores']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0038246', 'cui_str': 'Cervicothoracic Ganglion'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}]",100.0,0.229174,To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5,"[{'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Rae Olmsted', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bartoszek', 'Affiliation': 'Womack Army Medical Center, Fort Bragg, North Carolina.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mulvaney', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McLean', 'Affiliation': 'Tripler Army Medical Center, Honolulu, Hawaii.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Turabi', 'Affiliation': 'Landstuhl Regional Medical Center, Landstuhl, Germany.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Landstuhl Regional Medical Center, Landstuhl, Germany.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Womack Army Medical Center, Fort Bragg, North Carolina.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Vandermaas-Peeler', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Jessica Kelley', 'Initials': 'JK', 'LastName': 'Morgan', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Octav', 'Initials': 'O', 'LastName': 'Constantinescu', 'Affiliation': 'Landstuhl Regional Medical Center, Landstuhl, Germany.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kane', 'Affiliation': 'John F. Kennedy Special Warfare Center and School, Fort Bragg, North Carolina.'}, {'ForeName': 'Cuong', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Tripler Army Medical Center, Honolulu, Hawaii.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Hirsch', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Breda', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Croxford', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Lynch', 'Affiliation': 'US Army Special Operations Command, Fort Bragg, North Carolina.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'White', 'Affiliation': 'Landstuhl Regional Medical Center, Landstuhl, Germany.'}, {'ForeName': 'Bradford B', 'Initials': 'BB', 'LastName': 'Walters', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3474']
535,31704382,Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.,"OBJECTIVES


To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory.
METHODS


Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254).
RESULTS


Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes.
CONCLUSIONS


Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.",2019,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","['535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of', 'patients with OUD']","['BUP-NX', 'XR-NTX', 'buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'naltrexone and buprenorphine-naloxone']","['BUP-NX', 'XR-NTX']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],535.0,0.0141898,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol and Substance Use Studies, Graduate School of Applied and Professional Psychology, Rutgers University, New Brunswick, United States. Electronic address: lesia.ruglass@rutgers.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Biostatistics Department, Mailman School of Public Health, Columbia University, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, United States.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School and McLean Hospital, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University School of Medicine, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107649']
536,31343196,Sexual orientation and substance use treatment outcomes across five clinical trials of contingency management.,"Lesbian, gay, and bisexual (LGB) individuals have elevated rates of substance use disorders and present to treatment with more severe substance use problems. Despite this health disparity, recent reviews highlight the paucity of studies reporting sexual orientation in substance use research (e.g., Flentje, Bacca, & Cochran, 2015). Using data from 5 clinical trials of contingency management (CM), the current study investigated the impact of sexual orientation on 3 substance use outcomes: treatment retention, longest duration of abstinence, and percent negative samples submitted. Participants (N = 912; mean age = 36.6 years; 51.1% female; 45% African American, 42.2% Caucasian) were randomized to standard care in community-based intensive outpatient treatment (IOP) or the same plus CM. Patients identifying as LGB made up 10.6% of the sample. A significant proportion identified as bisexual (8.2% of the total sample). Regardless of sexual orientation, participants receiving CM achieved better treatment outcomes than those receiving IOP alone. There were no statistically significant differences between LGB and heterosexual participants in their response to IOP in general, and CM specifically, across all 3 treatment outcomes (ps > .05). However, equivalence testing revealed that outcomes were not statistically equivalent for LGB and heterosexual participants, with the exception of percentage of negative samples, which was equivalent within the CM group only. Differences in treatment response to CM and standard community-based IOP do not reach the level of statistical significance; however, in most cases, we cannot conclude that treatment response is equivalent for LGB and heterosexual individuals. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"There were no statistically significant differences between LGB and heterosexual participants in their response to IOP in general, and CM specifically, across all 3 treatment outcomes (ps > .05).","['Participants (N = 912; mean age = 36.6 years; 51.1% female; 45% African American, 42.2% Caucasian']","['contingency management (CM', 'standard care in community-based intensive outpatient treatment (IOP) or the same plus CM']",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],2019.0,0.0817234,"There were no statistically significant differences between LGB and heterosexual participants in their response to IOP in general, and CM specifically, across all 3 treatment outcomes (ps > .05).","[{'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Zajac', 'Affiliation': 'Calhoun Cardiology Center.'}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Rash', 'Affiliation': 'Calhoun Cardiology Center.'}, {'ForeName': 'Meredith K', 'Initials': 'MK', 'LastName': 'Ginley', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Heck', 'Affiliation': 'Putnam County Hospital.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000494']
537,31270116,Cost-effectiveness of a combined classroom curriculum and parental intervention: economic evaluation of data from the Steps Towards Alcohol Misuse Prevention Programme cluster randomised controlled trial.,"OBJECTIVES


This study aimed to assess the cost-effectiveness of the Steps Towards Alcohol Misuse Prevention Programme (STAMPP) compared with education as normal (EAN) in reducing self-reported heavy episodic drinking (HED) in adolescents.
DESIGN


This is a cost-effectiveness analysis from a public sector perspective conducted as part of a cluster randomised trial.
SETTING


This study was conducted in 105 high schools in Northern Ireland and in Scotland.
PARTICIPANTS


Students in school year 8/S1 (aged 11-12) at baseline were included in the study.
INTERVENTIONS


This is a classroom-based alcohol education curricula, combined with a brief alcohol intervention for parents/carers.
OUTCOME MEASURES


The outcome of this study is the cost per young person experiencing HED avoided due to STAMPP at 33 months from baseline.
RESULTS


The total cost of STAMPP was £85 900, equivalent to £818 per school and £15 per pupil. Due to very low uptake of the parental component, we calculated costs of £692 per school and £13 per pupil without this element. Costs per pupil were reduced further to £426 per school and £8 per pupil when it was assumed there were no additional costs of classroom delivery if STAMPP was delivered as part of activities such as personal, social, health and economic education. STAMPP was associated with a significantly greater proportion of pupils experiencing a heavy drinking episode avoided (0.08/8%) and slightly lower public sector costs (mean difference -£17.19). At a notional willingness-to-pay threshold of £15 (reflecting the cost of STAMPP), the probability of STAMPP being cost-effective was 56%. This level of uncertainty reflected the substantial variability in the cost differences between groups.
CONCLUSIONS


STAMPP was relatively low cost and reduced HED. STAMPP was not associated with any clear public sector cost savings, but neither did it increase them or lead to any cost-shifting within the public sector categories. Further research is required to establish if the cost-effectiveness of STAMPP is sustained in the long term.
TRIAL REGISTRATION NUMBER


ISRCTN47028486; Results.",2019,STAMPP was associated with a significantly greater proportion of pupils experiencing a heavy drinking episode avoided (0.08/8%) and slightly lower public sector costs (mean difference -£17.19).,"['self-reported heavy episodic drinking (HED) in adolescents', 'parents/carers', '105 high schools in Northern Ireland and in Scotland', 'Students in school year 8/S1 (aged 11-12) at baseline were included in the study']","['Steps Towards Alcohol Misuse Prevention Programme (STAMPP', 'combined classroom curriculum and parental intervention', 'STAMPP', 'alcohol intervention']","['total cost of STAMPP', 'Costs per pupil', 'Cost-effectiveness', 'public sector costs', 'low cost and reduced HED', 'cost-effectiveness', 'proportion of pupils experiencing a heavy drinking episode avoided']","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556342', 'cui_str': 'Drinking episode (finding)'}]",,0.0404408,STAMPP was associated with a significantly greater proportion of pupils experiencing a heavy drinking episode avoided (0.08/8%) and slightly lower public sector costs (mean difference -£17.19).,"[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Agus', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool School of Life Sciences, Liverpool, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool School of Life Sciences, Liverpool, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Foxcroft', 'Affiliation': 'Psychology and Public Health, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Séamus', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'School of Sport, Health and Exercise Sciences, University of Bangor, Bangor, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Murphy', 'Affiliation': 'Northern Ireland Clinical Trials Unit, The Royal Hospitals, Belfast, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Percy', 'Affiliation': ""School of Social Sciences, Education and Social Work, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Public Health Institute, Liverpool John Moores University, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027951']
538,30696686,Multicomponent non-pharmacological intervention to prevent delirium for hospitalised people with advanced cancer: study protocol for a phase II cluster randomised controlled trial.,"INTRODUCTION


Delirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group.
METHODS AND ANALYSIS


The study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial.
ETHICS AND DISSEMINATION


Ethical approval was obtained for all four sites. Trial results, qualitative substudy findings and implementation of the intervention will be submitted for publication in peer-reviewed journals, and reported at conferences, to study sites and key peak bodies.
TRIAL REGISTRATION NUMBER


ACTRN12617001070325; Pre-results.",2019,"The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients.","['inpatients with advanced cancer at four Australian palliative care inpatient units', '40 consecutively admitted eligible patients', 'inpatients with advanced cancer', 'hospitalised patients', 'hospitalised people with advanced cancer']","['multicomponent non-pharmacological delirium prevention intervention', 'multicomponent intervention', 'Multicomponent non-pharmacological intervention', 'multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership']","['adherence to the intervention during the first seven\u2009days of admission', 'fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures', 'delirium incidence']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",40.0,0.0805554,"The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients.","[{'ForeName': 'Annmarie', 'Initials': 'A', 'LastName': 'Hosie', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Noble', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Brassil', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kurrle', 'Affiliation': 'Hornsby Ku-ring-gai Health Service, Northern Clinical School, University of Sydney, Hornsby, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cumming', 'Affiliation': 'Australian Commission on Safety and Quality in Healthcare, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gideon A', 'Initials': 'GA', 'LastName': 'Caplan', 'Affiliation': 'Geriatric Medicine, Prince of Wales Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chye', 'Affiliation': ""Sacred Heart Health Service, St. Vincent's Hospital, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Le', 'Affiliation': 'Palliative and Supportive Services, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'E Wesley', 'Initials': 'EW', 'LastName': 'Ely', 'Affiliation': ""Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University, and the Tennessee Valley Veteran's Affairs Geriatric Research Education Clinical Center (GRECC), Nashville TN USA, Nashville, Tennessee, USA.""}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Lawlor', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Shirley H', 'Initials': 'SH', 'LastName': 'Bush', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jan Maree', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Palliative Care, Calvary Health Care Kogarah, Sydney, New South Wales, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lovell', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Fazekas', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Seong Leang', 'Initials': 'SL', 'LastName': 'Cheah', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Layla', 'Initials': 'L', 'LastName': 'Edwards', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Agar', 'Affiliation': 'IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, University of Technology Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2018-026177']
539,32022887,Effect of Hydrocortisone vs Pasireotide on Pancreatic Surgery Complications in Patients With High Risk of Pancreatic Fistula: A Randomized Clinical Trial.,"Importance


Both hydrocortisone and pasireotide have been shown in randomized clinical trials to be effective in reducing postoperative complications of pancreatic surgery, but to date no randomized clinical trial has evaluated the effectiveness of pasireotide compared with hydrocortisone.
Objective


To assess the noninferiority of hydrocortisone compared with pasireotide in reducing complications after partial pancreatectomy.
Design, Setting, and Participants


A noninferiority, parallel-group, individually randomized clinical trial was conducted at a single academic center between May 19, 2016, and December 17, 2018. Outcome collectors and analyzers were blinded. A total of 281 patients undergoing partial pancreatectomy were assessed for inclusion. Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded. Modified intention-to-treat analysis was used in determination of the results.
Interventions


Treatment included pasireotide, 900 μg, subcutaneously twice a day for 7 days or hydrocortisone, 100 mg, intravenously 3 times a day for 3 days.
Main Outcomes and Measures


The primary outcome was the Comprehensive Complication Index (CCI) score within 30 days. The noninferiority limit was set to 9 CCI points.
Results


Of the 281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses. Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received hydrocortisone (25 men [40%]; median [interquartile range] age, 67 [56-73] years). The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior. Postoperative pancreatic fistula was detected in 34 patients (54%) in the pasireotide group and 39 patients (62%) in the hydrocortisone group (odds ratio, 1.39; 95% CI, 0.68-2.82; P = .37). One patient in the pasireotide group and 2 patients in the hydrocortisone group died within 30 days. In subgroup analyses of patients undergoing distal pancreatectomy, the CCI score was a mean of 10.3 points lower (mean [SD], 16.03 [11.94] vs 26.28 [21.76]; 2-sided 95% CI, -19.34 to -2.12; P = .03) and postoperative pancreatic fistula rate was lower (37% vs 67%; P = .02) in the pasireotide group compared with the hydrocortisone group.
Conclusions and Relevance


In this study, hydrocortisone was not noninferior compared with pasireotide in patients undergoing partial pancreatectomy. Pasireotide may be more effective than hydrocortisone in patients undergoing distal pancreatectomy.
Trial Registration


ClinicalTrials.gov identifier: NCT02775227; EudraCT identifier: 2016-000212-16.",2020,"The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.","['281 patients (mean [SD] age, 63.8 years) assessed for eligibility, 168 patients (mean [SD] age, 63.6 years) were randomized and 126 were included in the modified intention-to-treat analyses', '25 men [40%]; median [interquartile range] age, 67 [56-73] years', '281 patients undergoing partial pancreatectomy were assessed for inclusion', 'patients undergoing partial pancreatectomy', 'Sixty-three patients received pasireotide (35 men [56%]; median [interquartile range] age, 64 [56-70] years) and 63 patients received', 'Patients younger than 18 years, those allergic to hydrocortisone or pasireotide, patients undergoing pancreaticoduodenectomy with hard pancreas or dilated pancreatic duct, and patients not eventually undergoing partial pancreatectomy were excluded', 'Patients', 'patients undergoing distal pancreatectomy', 'Pancreatic Fistula']","['hydrocortisone and pasireotide', 'pasireotide', 'Hydrocortisone vs Pasireotide', 'hydrocortisone']","['mean (SD) CCI score', 'postoperative pancreatic fistula rate', 'Postoperative pancreatic fistula', 'Comprehensive Complication Index (CCI) score', 'Pancreatic Surgery Complications', 'CCI score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0161912', 'cui_str': 'Partial pancreatectomy (procedure)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0085162', 'cui_str': 'Pancreatoduodenectomy'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0030274', 'cui_str': 'Pancreas'}, {'cui': 'C0030288', 'cui_str': 'Pancreatic duct structure (body structure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy (procedure)'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic Fistula'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",281.0,0.604697,"The mean (SD) CCI score was 23.94 (17.06) in the pasireotide group and 30.11 (20.47) in the hydrocortisone group (mean difference, -6.16; 2-sided 90% CI, -11.73 to -0.60), indicating that hydrocortisone was not noninferior.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Tarvainen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Sirén', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Kokkola', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Sallinen', 'Affiliation': 'Department of Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2019.6019']
540,31140709,Impact of intensively lowered low-density lipoprotein cholesterol on deferred lesion prognosis.,"OBJECTIVES


The aim of this study was to investigate the impact of intensively lowered low-density lipoprotein cholesterol (LDL-C) level on the deferred lesion prognosis after revascularization deferral based on fractional flow reserve (FFR).
BACKGROUND


Lowering LDL-C is associated with lower cardiovascular event rate, but its benefit on the deferred lesion prognosis has not been well evaluated.
METHODS


This retrospective, single-center, observational study analyzed 192 deferred lesions with FFR value >0.80 in 192 patients with stable coronary artery disease. According to the first follow-up LDL-C level, they were assigned to the LOW group (<70 mg/dL) or the HIGH group (≥70 mg/dL). Deferred lesion failure (DLF) was defined as the composite of deferred lesion revascularization and deferred vessel myocardial infarction.
RESULTS


Of all participants, 61 and 131 patients were assigned to the LOW and the HIGH group, respectively. During the median follow-up of 2.8 years, DLF occurred in 1 and 14 patients in the LOW group and the HIGH group (1.6% and 10.7%, log-rank p = .043), respectively. The incidence of any unplanned revascularization was also significantly lower in the LOW group than in the HIGH group (3.3% vs. 14.5%, log-rank p = .032).
CONCLUSIONS


The incidence of DLF was significantly lower in the patients with LDL-C < 70 mg/dL than in those with LDL-C ≥ 70 mg/dL at the first follow-up after FFR-based deferral of revascularization.",2020,The incidence of DLF was significantly lower in the patients with LDL-C < 70 mg/dL than in those with LDL-C ≥ 70 mg/dL at the first follow-up after FFR-based deferral of revascularization.,"['192 deferred lesions with FFR value >0.80 in 192 patients with stable coronary artery disease', '61 and 131 patients']",[],"['incidence of any unplanned revascularization', 'fractional flow reserve (FFR', 'Deferred lesion failure (DLF', 'low-density lipoprotein cholesterol (LDL-C) level', 'incidence of DLF', 'DLF']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",192.0,0.0312504,The incidence of DLF was significantly lower in the patients with LDL-C < 70 mg/dL than in those with LDL-C ≥ 70 mg/dL at the first follow-up after FFR-based deferral of revascularization.,"[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Teng', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Sawa', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Kasano', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Yoshiwara', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Eijiro', 'Initials': 'E', 'LastName': 'Hattori', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Tokunaga', 'Affiliation': 'JA Toride Medical Center, Ibaraki, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Yonetsu', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Tokyo Medical and Dental University, Tokyo, Japan.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28345']
541,30718620,Magnocellular Based Visual Motion Training Improves Reading in Persian.,"The visual magnocellular system is thought to play a crucial role in learning to read. Here therefore, we examined whether magnocellular based training could improve reading in children with visual reading problems. The participants were 24 male primary school students aged between 9-11 (Mean = 9.76, SD = 0.59) with specific reading difficulty. Experimental and control groups were matched for age, sex, educational level, IQ, reading abilities (measured by APRA), magnocellular performance as assessed by a random dot kinematogram (RDK) paradigm and recordings of their saccadic eye movements. The experimental group received twelve magnocellular based visual motion training sessions, twice a week over 6 weeks. During the same period, the control group played a video game with the help of a practitioner. All measures were made just prior to the training and were repeated at the 6 th , 12 th  training session and one month later. The experimental group showed significant improvements in magnocellular function, visual errors and reading accuracy during the course of intervention. Follow-up assessment confirmed that these effects persisted one month later. Impaired magnocellular functioning appeared to be an important cause of poor reading in Persian. Hence magnocellular based training could help many children with specific reading difficulties. Also testing magnocellular function could be used as screening tool for detecting dyslexia before a child begins to fail at school.",2019,"The experimental group showed significant improvements in magnocellular function, visual errors and reading accuracy during the course of intervention.","['participants were 24 male primary school students aged between 9-11 (Mean\u2009=\u20099.76, SD\u2009=\u20090.59) with specific reading difficulty', 'children with visual reading problems']","['random dot kinematogram (RDK) paradigm and recordings of their saccadic eye movements', 'magnocellular based training', 'Magnocellular Based Visual Motion Training', 'twelve magnocellular based visual motion training sessions']","['magnocellular function, visual errors and reading accuracy']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517465', 'cui_str': 'Zero point five nine'}, {'cui': 'C0476254', 'cui_str': 'Reading Disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0036019', 'cui_str': 'Saccadic Eye Movements'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",24.0,0.0108409,"The experimental group showed significant improvements in magnocellular function, visual errors and reading accuracy during the course of intervention.","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ebrahimi', 'Affiliation': 'Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Pouretemad', 'Affiliation': 'Institute for Cognitive & Brain Sciences, Shahid Beheshti University, Tehran, Iran. h-pouretemad@sbu.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khatibi', 'Affiliation': 'Department of Psychology, Bilkent University, 06800, Ankara, Turkey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stein', 'Affiliation': 'Tehran-Oxford Neurodevelopmental Center, Shahid Beheshti University, Tehran, Iran.'}]",Scientific reports,['10.1038/s41598-018-37753-7']
542,31570566,"Selective Progesterone Receptor Modulators in Early-Stage Breast Cancer: A Randomized, Placebo-Controlled Phase II Window-of-Opportunity Trial Using Telapristone Acetate.","PURPOSE


Selective progesterone receptor modulators (SPRMs) show preclinical activity against hormone-sensitive breast cancer, but have not been tested in patients with early, treatment-naïve tumors.
PATIENTS AND METHODS


In a double-blind presurgical window trial of oral telapristone acetate (TPA) 12 mg daily versus placebo, 70 patients with early-stage breast cancer were randomized 1:1 (stratified by menopause) and treated for 2 to 10 weeks. The primary endpoint was change in Ki67 between diagnostic biopsy and surgical specimens. Gene expression pre- and posttherapy was assessed using RNA-sequencing and gene set enrichment analysis was performed to determine pathways enriched in response to TPA and placebo treatments.
RESULTS


Among 61 evaluable women (29 placebo and 32 telapristone acetate), 91% of tumors were ER/PR positive. The mean Ki67 declined by 5.5% in all women treated with telapristone acetate ( P  = 0.003), and by 4.2% in all women treated with placebo ( P  = 0.04). After menopausal stratification, the Ki67 decline remained significant in 22 telapristone acetate-treated premenopausal women ( P  = 0.03). Differential gene expression analysis showed no significant modulation overall. However, in a subset of tumors that demonstrated ≥30% relative reduction in Ki67 in the telapristone acetate group, genes related to cell-cycle progression, and those in the HER2 amplicon were significantly downregulated. In contrast, no significantly enriched pathways were identified in the placebo group.
CONCLUSIONS


Patients treated with telapristone acetate whose Ki67 decreased by ≥30% demonstrated a selective antiproliferative signal, with a potentially important effect on HER2 amplicon genes. Evaluation of SPRMs in a neoadjuvant trial is merited, with attention to predictors of response to SPRM therapy, and inclusion of pre- and postmenopausal women.",2020,"The mean Ki67 declined by 5.5% in all TPA-treated women (p= 0.003), and by 4.2% in all placebo-treated women (p=0.04).","['early stage breast cancer', 'patients with early, treatment-naïve tumors', '70 early stage breast cancer patients']","['progesterone receptor modulators (SPRMs', 'placebo', 'oral telapristone acetate (TPA', 'Selective progesterone receptor modulators', 'telapristone acetate']","['change in Ki67 between diagnostic biopsy and surgical specimens', 'HER2 amplicon', 'mean Ki67']","[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3501648', 'cui_str': 'telapristone acetate'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",70.0,0.25022,"The mean Ki67 declined by 5.5% in all TPA-treated women (p= 0.003), and by 4.2% in all placebo-treated women (p=0.04).","[{'ForeName': 'Oukseub', 'Initials': 'O', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Sullivan', 'Affiliation': 'Department of Pathology of NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Yanfei', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Muzzio', 'Affiliation': 'Illinois Institute of Technology Research Institute, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Helenowski', 'Affiliation': 'Department of Surgery Preventive Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shidfar', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Zexian', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Department of Surgery Preventive Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Singhal', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Borko', 'Initials': 'B', 'LastName': 'Jovanovic', 'Affiliation': 'Department of Surgery Preventive Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Hansen', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Bethke', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gann', 'Affiliation': 'Department of Pathology, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': 'Department of Surgery Medicine, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'J Julie', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, Illinois. s-khan2@northwestern.edu susan.clare@northwestern.edu j-kim4@northwestern.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Clare', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois. s-khan2@northwestern.edu susan.clare@northwestern.edu j-kim4@northwestern.edu.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Department of Surgery, University of Illinois at Chicago, Chicago, Illinois. s-khan2@northwestern.edu susan.clare@northwestern.edu j-kim4@northwestern.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0443']
543,32122153,Active chest tube clearance after aortic valve surgery did not influence amount residual pericardial fluid after aortic valve replacement in a randomised trial.,"Objective.  Evaluate if the use of active clearance of chest tubes after aortic valve surgery influenced bleeding and reduced postoperative residual pericardial effusion.  Design.  Prospective randomised trial comparing PleuraFlow ®  32 F chest tube with FlowGlide™ active clearance to a standard Argyle ®  32 F chest tube in 100 patients undergoing aortic valve surgery. Chest tube outputs and pericardial effusion measurements assessed by two-dimensional transthoracic echocardiography were recorded before hospital discharge.  Results.  Postoperative chest tube outputs per hour did not differ between the two groups. The median chest tube output was 400 mL for patients who had a PleuraFlow ®  chest tube  vs . 490 mL for patients with an Argyle ®  chest tube ( p  = .08). Pericardial effusions ≥ 2 mm were detected in 76%  vs.  68% of the patients ( p  = .50) and postoperative atrial fibrillation occurred in 42%  vs . 34% ( p  = .54), respectively.  Conclusions.  Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.",2020,"Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.",['100 patients undergoing aortic valve surgery'],['PleuraFlow ®  32\u2009F chest tube with FlowGlide™ active clearance to a standard Argyle ®  32\u2009F chest tube'],"['Postoperative chest tube outputs per hour', 'postoperative atrial fibrillation', 'postoperative bleeding or degree of pericardial effusion', 'median chest tube output']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0349077', 'cui_str': 'Pericardial effusion - noninflammatory (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",100.0,0.0694004,"Use of active clearance chest tubes, compared to standard chest tubes after aortic valve surgery did not differ significantly regarding postoperative bleeding or degree of pericardial effusion as measured by echocardiography prior to hospital discharge.","[{'ForeName': 'Linnéa', 'Initials': 'L', 'LastName': 'Malgerud', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Maret', 'Affiliation': 'Department of Clinical Physiology, Karolinska University Hospital, and Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reitan', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm and Department of Cardiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Ivert', 'Affiliation': 'Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1728373']
544,31950979,"Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial.","Importance


It is unclear whether vitamin C, hydrocortisone, and thiamine are more effective than hydrocortisone alone in expediting resolution of septic shock.
Objective


To determine whether the combination of vitamin C, hydrocortisone, and thiamine, compared with hydrocortisone alone, improves the duration of time alive and free of vasopressor administration in patients with septic shock.
Design, Setting, and Participants


Multicenter, open-label, randomized clinical trial conducted in 10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock. The first patient was enrolled on May 8, 2018, and the last on July 9, 2019. The final date of follow-up was October 6, 2019.
Interventions


Patients were randomized to the intervention group (n = 109), consisting of intravenous vitamin C (1.5 g every 6 hours), hydrocortisone (50 mg every 6 hours), and thiamine (200 mg every 12 hours), or to the control group (n = 107), consisting of intravenous hydrocortisone (50 mg every 6 hours) alone until shock resolution or up to 10 days.
Main Outcomes and Measures


The primary trial outcome was duration of time alive and free of vasopressor administration up to day 7. Ten secondary outcomes were prespecified, including 90-day mortality.
Results


Among 216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63%]). Time alive and vasopressor free up to day 7 was 122.1 hours (interquartile range [IQR], 76.3-145.4 hours) in the intervention group and 124.6 hours (IQR, 82.1-147.0 hours) in the control group; the median of all paired differences was -0.6 hours (95% CI, -8.3 to 7.2 hours; P = .83). Of 10 prespecified secondary outcomes, 9 showed no statistically significant difference. Ninety-day mortality was 30/105 (28.6%) in the intervention group and 25/102 (24.5%) in the control group (hazard ratio, 1.18; 95% CI, 0.69-2.00). No serious adverse events were reported.
Conclusions and Relevance


In patients with septic shock, treatment with intravenous vitamin C, hydrocortisone, and thiamine, compared with intravenous hydrocortisone alone, did not significantly improve the duration of time alive and free of vasopressor administration over 7 days. The finding suggests that treatment with intravenous vitamin C, hydrocortisone, and thiamine does not lead to a more rapid resolution of septic shock compared with intravenous hydrocortisone alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT03333278.",2020,"No serious adverse events were reported.
","['Patients With Septic Shock', '216 patients who were randomized, 211 provided consent and completed the primary outcome measurement (mean age, 61.7 years [SD, 15.0]; 133 men [63', '10 intensive care units in Australia, New Zealand, and Brazil that recruited 216 patients fulfilling the Sepsis-3 definition of septic shock', 'The first patient was enrolled on May 8, 2018, and the last on July 9, 2019', 'patients with septic shock']","['intravenous vitamin C, hydrocortisone, and thiamine', 'intravenous hydrocortisone', 'hydrocortisone alone', 'vitamin C, hydrocortisone, and thiamine', 'intravenous vitamin C', 'thiamine', 'hydrocortisone', 'Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone']","['Time alive and vasopressor free', 'Ninety-day mortality', 'duration of time alive and free of vasopressor administration up to day 7', 'serious adverse events', 'duration of time alive and free of vasopressor administration', 'Time Alive and Free of Vasopressor Support', '90-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",216.0,0.416565,"No serious adverse events were reported.
","[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Frei', 'Affiliation': 'Department of Anaesthesia and Pain Medicine, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ludhmila A', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Gisele', 'Initials': 'G', 'LastName': 'Oliveira', 'Affiliation': 'Cancer Institute of the State of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Edney', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Hunt', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Judd', 'Affiliation': 'Intensive Care Unit, Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bitker', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thummaporn', 'Initials': 'T', 'LastName': 'Naorungroj', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Yanase', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Forbes', 'Initials': 'F', 'LastName': 'McGain', 'Affiliation': 'Department of Intensive Care, Anaesthesia, Pain, and Perioperative Medicine, Footscray Hospital, Western Health, Footscray, Melbourne, Victoria, Australia.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Hudson', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Wisam', 'Initials': 'W', 'LastName': 'Al-Bassam', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Dhiraj Bhatia', 'Initials': 'DB', 'LastName': 'Dwivedi', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Peppin', 'Affiliation': 'Critical Care and Perioperative Services, School of Clinical Sciences, Monash University and Monash Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'McCracken', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Orosz', 'Affiliation': 'Department of Intensive Care and Hyperbaric Medicine, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2019.22176']
545,31501165,Rehabilitation of patients after transient ischaemic attack or minor stroke: pilot feasibility randomised trial of a home-based prevention programme.,"BACKGROUND


Although the importance of secondary prevention after transient ischaemic attack (TIA) or minor stroke is recognised, research is sparse regarding novel, effective ways in which to intervene in a primary care context.
AIM


To pilot a randomised controlled trial (RCT) of a novel home-based prevention programme ( The Healthy Brain Rehabilitation Manual ) for patients with TIA or 'minor' stroke.
DESIGN AND SETTING


Pilot RCT, home-based, undertaken in Northern Ireland between May 2017 and March 2018.
METHOD


Patients within 4 weeks of a first TIA or 'minor' stroke received study information from clinicians in four hospitals. Participants were randomly allocated to one of three groups: standard care (control group) ( n  = 12); standard care with manual and GP follow-up ( n  = 14); or standard care with manual and stroke nurse follow-up ( n  = 14). Patients in all groups received telephone follow-up at 1, 4, and 9 weeks. Eligibility, recruitment, and retention were assessed; stroke/cardiovascular risk factors measured at baseline and 12 weeks; and participants' views were elicited about the study via focus groups.
RESULTS


Over a 32-week period, 28.2% of clinic attendees (125/443) were eligible; 35.2% of whom (44/125) consented to research contact; 90.9% of these patients (40/44) participated, of whom 97.5% (39/40) completed the study. After 12 weeks, stroke risk factors [cardiovascular risk factors, including blood pressure and measures of physical activity] improved in both intervention groups. The research methods and the programme were acceptable to patients and health professionals, who commented that the programme 'filled a gap' in current post-TIA management.
CONCLUSION


Findings indicate that implementation of this novel cardiac rehabilitation programme, and of a trial to evaluate its effectiveness, is feasible, with potential for clinically important benefits and improved secondary prevention after TIA or 'minor' stroke.",2019,"The research methods and the programme were acceptable to patients and health professionals, who commented that the programme 'filled a gap' in current post-TIA management.
","['clinic attendees (125/443) were eligible; 35.2% of whom (44/125) consented to research contact; 90.9% of these patients (40/44) participated, of whom 97.5% (39/40) completed the study', ""Patients within 4 weeks of a first TIA or 'minor' stroke received study information from clinicians in four hospitals"", ""patients with TIA or 'minor' stroke"", 'Pilot RCT, home-based, undertaken in Northern Ireland between May 2017 and March 2018', 'patients after transient ischaemic attack or minor stroke']","['standard care (control group) ( n  = 12); standard care with manual and GP follow-up ( n  = 14); or standard care with manual and stroke nurse follow-up', 'novel home-based prevention programme ( The Healthy Brain Rehabilitation Manual ', 'home-based prevention programme']","['stroke/cardiovascular risk factors', 'stroke risk factors [cardiovascular risk factors, including blood pressure and measures of physical activity']","[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0818232,"The research methods and the programme were acceptable to patients and health professionals, who commented that the programme 'filled a gap' in current post-TIA management.
","[{'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Heron', 'Affiliation': ""Department of Primary Care, Keele University, Keele; Centre for Public Health, Queen's University Belfast, Belfast.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kee', 'Affiliation': ""Queen's University Belfast, Belfast.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Mant', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Cupples', 'Affiliation': 'Department of General Practice and Primary Care; Centre for Public Health.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast; UKCRC Centre of Excellence for Public Health Research, Belfast.""}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp19X705509']
546,31339533,Effectiveness of the American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types: A Randomized Clinical Trial.,"Importance


More than 500 000 laypeople in the United States have been trained in hemorrhage control, including tourniquet application, under the Stop the Bleed campaign. However, it is unclear whether after hemorrhage control training participants become proficient in a specific type of tourniquet or can also use other tourniquets effectively.
Objective


To assess whether participants completing the American College of Surgeons Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs) can effectively apply bleeding control principles using other tourniquet types (commercial and improvised).
Design, Setting, and Participants


This nonblinded, crossover, sequential randomized clinical trial with internal control assessed a volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018. The order of application varied for each participant using randomly generated permutated blocks.
Interventions


Full B-Con course, including cognitive and skill sessions, that taught bleeding care, wound pressure and packing, and CAT application.
Main Outcomes and Measures


Correct tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap) in a simulated scenario for 3 commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test.
Results


A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study. Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%; Rapid Application Tourniquet System, 11.8%) and the improvised tourniquet (32.4%) (P < .001 for each pairwise comparison). When comparing tourniquets applied correctly, all tourniquet types had higher estimated blood loss, had longer application time, and applied less pressure than the CAT.
Conclusions and Relevance


The B-Con principles for correct CAT application are not fully translatable to other commercial or improvised tourniquet types. This study demonstrates a disconnect between the B-Con course and tourniquet designs available for bystander first aid, potentially stemming from the lack of consensus guidelines. These results suggest that current B-Con trainees may not be prepared to care for bleeding patients as tourniquet design evolves.
Trial Registration


ClinicalTrials.gov identifier: NCT03538379.",2019,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","['participants completing the American College of Surgeons', 'A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study', 'volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018', 'American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types']",['Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs'],"['commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test', 'blood loss', 'Measures\n\n\nCorrect tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0442588', 'cui_str': 'Stadium (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0524517', 'cui_str': 'Felis'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",102.0,0.0461564,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'McCarty', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Zain G', 'Initials': 'ZG', 'LastName': 'Hashmi', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Herrera-Escobar', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Elzerie', 'Initials': 'E', 'LastName': 'de Jager', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Muhammad Ali', 'Initials': 'MA', 'LastName': 'Chaudhary', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Lipsitz', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Jarman', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Caterson', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goralnick', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA surgery,['10.1001/jamasurg.2019.2275']
547,31315861,The NeMo real-time fMRI neurofeedback study: protocol of a randomised controlled clinical intervention trial in the neural foundations of mother-infant bonding.,"INTRODUCTION


Most mothers feel an immediate, strong emotional bond with their newborn. On a neurobiological level, this is accompanied with the activation of the brain reward systems, including the striatum. However, approximately 10% of all mothers report difficulties to bond emotionally with their infant and display impaired reward responses to the interaction with their infant which might have long-term negative effects for the child's development. As previous studies suggest that activation of the striatal reward system can be regulated through functional MRI (fMRI)-based neurofeedback (NFB), we have designed and investigate fMRI-NFB training to treat maternal bonding difficulties.
METHODS AND ANALYSIS


In the planned trial, mothers will be presented pictures of their infant and real-time fMRI (rtfMRI), peripheral measures, neural, endocrine, psychophysiological and behavioural measures will be assessed. Mothers with bonding difficulties (n=68) will be randomised to one of two double-blind intervention groups at 4-6 months postpartum. They will participate in three repeated NFB training sessions with rtfMRI-NFB training to increase activation of (a) the ventral striatum or (b) the anterior cingulate. Interview data and real-time mother-infant interaction behaviour pre-intervention, post-intervention and at follow-up will serve as clinical outcome measures.
ETHICS AND DISSEMINATION


Study procedures are in line with the recommendations of the World Medical Association (revised Declaration of Helsinki) and were approved by the Ethics Committee of the Medical Faculty, s-450/2017, Heidelberg University. All participants will provide written informed consent after receiving a detailed oral and written explanation of all procedures and can withdraw their consent at any time without negative consequence. Results will be internationally published and disseminated, to further the discussion on non-pharmacological treatment options in complex mental disorders.
TRIAL REGISTRATION NUMBER


DRKS00014570; Pre-results.",2019,"Interview data and real-time mother-infant interaction behaviour pre-intervention, post-intervention and at follow-up will serve as clinical outcome measures.
","['mother-infant bonding', 'Mothers with bonding difficulties (n=68']",['rtfMRI-NFB training'],"['pictures of their infant and real-time fMRI (rtfMRI), peripheral measures, neural, endocrine, psychophysiological and behavioural measures']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0780612,"Interview data and real-time mother-infant interaction behaviour pre-intervention, post-intervention and at follow-up will serve as clinical outcome measures.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Eckstein', 'Affiliation': 'Institute of Medical Psychology in the Center for Psychosocial Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Zietlow', 'Affiliation': 'Institute of Medical Psychology in the Center for Psychosocial Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martin Fungisai', 'Initials': 'MF', 'LastName': 'Gerchen', 'Affiliation': 'Department of Clinical Psychology, Central Institute for Mental Health, Mannheim, Germany.'}, {'ForeName': 'Mike Michael', 'Initials': 'MM', 'LastName': 'Schmitgen', 'Affiliation': 'Department of General Psychiatry, UniversitatsKlinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ashcroft-Jones', 'Affiliation': 'Institute of Medical Psychology in the Center for Psychosocial Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kirsch', 'Affiliation': 'Department of Clinical Psychology, Central Institute for Mental Health, Mannheim, Germany.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Ditzen', 'Affiliation': 'Institute of Medical Psychology in the Center for Psychosocial Medicine, UniversitatsKlinikum Heidelberg, Heidelberg, Germany.'}]",BMJ open,['10.1136/bmjopen-2018-027747']
548,31617873,Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia: A Randomized Clinical Trial.,"Importance


Negative symptoms represent a substantial burden in schizophrenia. Although preliminary studies have suggested that transcranial direct current stimulation (tDCS) is effective for some clusters of symptoms, the clinical benefits for negative symptoms are unclear.
Objective


To determine the efficacy and safety of tDCS vs sham as an add-on treatment for patients with schizophrenia and predominant negative symptoms.
Design, Setting, and Participants


The double-blind Schizophrenia Treatment With Electric Transcranial Stimulation (STARTS) randomized clinical trial was conducted from September 2014 to March 2018 in 2 outpatient clinics in the state of São Paulo, Brazil. Patients with schizophrenia with stable negative and positive symptoms and a minimum score of 20 points in the negative symptoms subscale of the Positive and Negative Syndrome Scale (PANSS) were included.
Interventions


Ten sessions of tDCS performed twice a day for 5 days or a sham procedure. The anode and the cathode were positioned over the left prefrontal cortex and the left temporoparietal junction, respectively.
Main Outcomes and Measures


Change in the PANSS negative symptoms subscale score at week 6 was the primary outcome. Patients were followed-up for an additional 6 weeks.
Results


Of the 100 included patients, 20 (20.0%) were female, and the mean (SD) age was 35.3 (9.3) years. A total of 95 patients (95.0%) finished the trial. In the intention-to-treat analysis, patients receiving active tDCS showed a significantly greater improvement in PANSS score compared with those receiving the sham procedure (difference, 2.65; 95% CI, 1.51-3.79; number needed to treat, 3.18; 95% CI, 2.12-6.99; P < .001). Response rates for negative symptoms (20% improvement or greater) were also higher in the active group (20 of 50 [40%]) vs the sham group (2 of 50 [4%]) (P < .001). These effects persisted at follow-up. Transcranial direct current stimulation was well tolerated, and adverse effects did not differ between groups, except for burning sensation over the scalp in the active group (43.8%) vs the sham group (14.3%) (P = .003).
Conclusions and Relevance


Transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia.
Trial Registration


ClinicalTrials.gov identifier: NCT02535676.",2020,"Transcranial direct current stimulation was well tolerated, and adverse effects did not differ between groups, except for burning sensation over the scalp in the active group (43.8%) vs the sham group (14.3%) (P = .003).
","['Patients with schizophrenia with stable negative and positive symptoms and a minimum score of 20 points in the negative symptoms subscale of the Positive and Negative Syndrome Scale (PANSS) were included', 'patients with schizophrenia', 'patients with schizophrenia and predominant negative symptoms', 'September 2014 to March 2018 in 2 outpatient clinics in the state of São Paulo, Brazil', '100 included patients, 20 (20.0%) were female, and the mean (SD) age was 35.3 (9.3) years', 'Schizophrenia']","['Transcranial Direct Current Stimulation', 'tDCS', 'Schizophrenia Treatment', 'Transcranial direct current stimulation', 'transcranial direct current stimulation (tDCS', 'Electric Transcranial Stimulation']","['Response rates for negative symptoms', 'tolerated, and adverse effects', 'PANSS score', 'efficacy and safety', 'PANSS negative symptoms subscale score', 'burning sensation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation (finding)'}]",95.0,0.5944,"Transcranial direct current stimulation was well tolerated, and adverse effects did not differ between groups, except for burning sensation over the scalp in the active group (43.8%) vs the sham group (14.3%) (P = .003).
","[{'ForeName': 'Leandro da Costa Lane', 'Initials': 'LDCL', 'LastName': 'Valiengo', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Pedro Caldana', 'Initials': 'PC', 'LastName': 'Gordon', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Mauricio Henriques', 'Initials': 'MH', 'LastName': 'Serpa', 'Affiliation': 'Laboratory of Neuroimaging (LIM-21), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Koebe', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leonardo Afonso Dos', 'Initials': 'LAD', 'LastName': 'Santos', 'Affiliation': 'Instituto Bairral de Psiquiatria, Itapira, Brazil.'}, {'ForeName': 'Roger Alberto Marcos', 'Initials': 'RAM', 'LastName': 'Lovera', 'Affiliation': 'Instituto Bairral de Psiquiatria, Itapira, Brazil.'}, {'ForeName': 'Juliana Barbosa de', 'Initials': 'JB', 'LastName': 'Carvalho', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Martinus', 'Initials': 'M', 'LastName': 'van de Bilt', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Acioly L T', 'Initials': 'ALT', 'LastName': 'Lacerda', 'Affiliation': 'Programa de Transtornos Afetivos, Laboratório Interdisciplinar de Neurociências Clínicas, Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Elkis', 'Affiliation': 'Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Wagner Farid', 'Initials': 'WF', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3199']
549,31693077,Efficacy and Safety of Dupilumab in Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis: A Phase 3 Randomized Clinical Trial.,"Importance


Adolescents with atopic dermatitis (AD) have high disease burden negatively affecting quality of life, with limited treatment options. The efficacy and safety of dupilumab, a monoclonal antibody, approved for treatment in adolescent patients with inadequately controlled AD, remain unknown in this patient population.
Objective


To assess the efficacy and safety of dupilumab monotherapy in adolescents with moderate to severe inadequately controlled AD.
Design, Setting, and Participants


A randomized, double-blind, parallel-group, phase 3 clinical trial was conducted at 45 US and Canadian centers between March 21, 2017, and June 5, 2018. A total of 251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included.
Interventions


Patients were randomized (1:1:1; interactive-response system; stratified by severity and body weight) to 16-week treatment with dupilumab, 200 mg (n = 43; baseline weight <60 kg), or dupilumab, 300 mg (n = 39; baseline weight ≥60 kg), every 2 weeks; dupilumab, 300 mg, every 4 weeks (n = 84); or placebo (n = 85).
Main Outcomes and Measures


Proportion of patients with 75% or more improvement from baseline in Eczema Area and Severity Index (EASI-75) (scores range from 0 to 72, with higher scores indicating greater severity) and Investigator's Global Assessment (IGA) 0 or 1 on a 5-point scale (scores range from 0 to 4, with higher scores indicating greater severity) at week 16.
Results


A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male). Of 250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6%). A total of 240 patients (95.6%) completed the study. Dupilumab achieved both coprimary end points at week 16. The proportion of patients with EASI-75 improvement from baseline increased (every 2 weeks, 41.5%; every 4 weeks, 38.1%; placebo, 8.2%) with differences vs placebo of 33.2% (95% CI, 21.1%-45.4%) for every 2 weeks and 29.9% (95% CI, 17.9%-41.8%) for every 4 weeks (P < .001). Efficacy of the every-2-week regimen was generally superior to the every-4-week regimen. Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
Conclusions and Relevance


In this study, dupilumab significantly improved AD signs, symptoms, and quality of life in adolescents with moderate to severe AD, with an acceptable safety profile. Placebo-corrected efficacy and safety of dupilumab were similar in adolescents and adults.
Trial Registration


ClinicalTrials.gov identifier: NCT03054428.",2020,"Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
","['adolescent patients with inadequately controlled AD', 'Adolescents with atopic dermatitis (AD', '250 patients with data available on concurrent allergic conditions, most had comorbid type 2 diseases (asthma, 134 [53.6%]; food allergies, 60.8%; allergic rhinitis, 65.6', '251 adolescents with moderate to severe AD inadequately controlled by topical medications or for whom topical therapy was inadvisable were included', 'adolescents with moderate to severe inadequately controlled AD', 'adolescents with moderate to severe AD', 'adolescents and adults', 'A total of 251 patients were randomized (mean [SD] age, 14.5 [1.7] years; 148 [59.0%] male', 'Adolescents With Uncontrolled Moderate to Severe Atopic Dermatitis', '240 patients (95.6%) completed the study']","['dupilumab, 200 mg (n\u2009=\u200943; baseline weight <60 kg), or dupilumab', 'Placebo', 'placebo', 'dupilumab', 'Dupilumab', 'dupilumab monotherapy']","['AD signs, symptoms, and quality of life', 'injection-site reactions', ""severity) and Investigator's Global Assessment (IGA) 0 or 1 on a 5-point scale"", 'efficacy and safety', 'Efficacy', 'Efficacy and Safety', 'nonherpetic skin infections', 'proportion of patients with EASI-75 improvement', 'Eczema Area and Severity Index (EASI-75', 'percentage values of conjunctivitis']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0851444', 'cui_str': 'Allergic condition'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037278', 'cui_str': 'Skin Diseases, Infectious'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}]",251.0,0.507851,"Patients in the dupilumab arms had higher percentage values of conjunctivitis (every 2 weeks, 9.8%; every 4 weeks, 10.8%; placebo, 4.7%) and injection-site reactions (every 2 weeks, 8.5%; every 4 weeks, 6.0%; placebo, 3.5%), and lower nonherpetic skin infections (every 2 weeks, 9.8%; every 4 weeks, 9.6%; placebo, 18.8%).
","[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Siegfried', 'Affiliation': 'Department of Pediatrics, School of Medicine, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Boguniewicz', 'Affiliation': 'Department of Pediatrics, National Jewish Health and University of Colorado School of Medicine, Denver.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, California.'}, {'ForeName': 'Melinda J', 'Initials': 'MJ', 'LastName': 'Gooderham', 'Affiliation': 'Skin Centre for Dermatology, Peterborough, Ontario, Canada.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Weisman', 'Affiliation': 'Advanced Medical Research, Atlanta, Georgia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lockshin', 'Affiliation': 'US Dermatology Partners, Rockville, Maryland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Regeneron Pharmaceuticals Inc, Tarrytown, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3336']
550,31693081,Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial.,"Importance


Because inadvertent damage of parathyroid glands can lead to postoperative hypocalcemia, their identification and preservation, which can be challenging, are pivotal during total thyroidectomy.
Objective


To determine if intraoperative imaging systems using near-infrared autofluorescence (NIRAF) light to identify parathyroid glands could improve parathyroid preservation and reduce postoperative hypocalcemia.
Design, Setting, and Participants


This randomized clinical trial was conducted from September 2016 to October 2018, with a 6-month follow-up at 3 referral hospitals in France. Adult patients who met eligibility criteria and underwent total thyroidectomy were randomized. The exclusion criteria were preexisting parathyroid diseases.
Interventions


Use of intraoperative NIRAF imaging system during total thyroidectomy.
Main Outcomes and Measures


The primary outcome was the rate of postoperative hypocalcemia (a corrected calcium <8.0 mg/dL [to convert to mmol/L, multiply by 0.25] at postoperative day 1 or 2). The main secondary outcomes were the rates of parathyroid gland autotransplantation and inadvertent parathyroid gland resection.
Results


A total of 245 of 529 eligible patients underwent randomization. Overall, 241 patients were analyzed for the primary outcome (mean [SD] age, 53.6 [13.6] years; 191 women [79.3%]): 121 who underwent NIRAF-assisted thyroidectomy and 120 who underwent conventional thyroidectomy (control group). The temporary postoperative hypocalcemia rate was 9.1% (11 of 121 patients) in the NIRAF group and 21.7% (26 of 120 patients) in the control group (between-group difference, 12.6% [95% CI, 5.0%-20.1%]; P = .007). There was no significant difference in permanent hypocalcemia rates (0% in the NIRAF group and 1.6% [2 of 120 patients] in the control group). Multivariate analyses accounting for center and surgeon heterogeneity and adjusting for confounders, found that use of NIRAF reduced the risk of hypocalcemia with an odds ratio of 0.35 (95% CI, 0.15-0.83; P = .02). Analysis of secondary outcomes showed that fewer patients experienced parathyroid autotransplantation in the NIRAF group than in the control group: respectively, 4 patients (3.3% [95% CI, 0.1%-6.6%) vs 16 patients (13.3% [95% CI, 7.3%-19.4%]; P = .009). The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).
Conclusions and Relevance


The use of NIRAF for the identification of the parathyroid glands may help improve the early postoperative hypocalcemia rate significantly and increase parathyroid preservation after total thyroidectomy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02892253.",2020,"The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).
","['241 patients were analyzed for the primary outcome (mean [SD] age, 53.6 [13.6] years; 191 women [79.3%]): 121 who underwent NIRAF-assisted thyroidectomy and 120 who underwent conventional thyroidectomy (control group', 'A total of 245 of 529 eligible patients underwent randomization', 'September 2016 to October 2018, with a 6-month follow-up at 3 referral hospitals in France', 'During Total Thyroidectomy With Postoperative Hypocalcemia Risk', 'Adult patients who met eligibility criteria and underwent total thyroidectomy were randomized']","['intraoperative NIRAF imaging system', 'Parathyroid Glands', 'NIRAF']","['permanent hypocalcemia rates', 'number of inadvertently resected parathyroid glands', 'rate of postoperative hypocalcemia', 'temporary postoperative hypocalcemia rate', 'parathyroid autotransplantation', 'rates of parathyroid gland autotransplantation and inadvertent parathyroid gland resection', 'risk of hypocalcemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C4517806', 'cui_str': '529 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030518', 'cui_str': 'Parathyroid structure (body structure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",529.0,0.20402,"The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).
","[{'ForeName': 'Fares', 'Initials': 'F', 'LastName': 'Benmiloud', 'Affiliation': 'Endocrine Surgery Unit, Hôpital Européen Marseille, Marseille, France.'}, {'ForeName': 'Gaelle', 'Initials': 'G', 'LastName': 'Godiris-Petit', 'Affiliation': 'General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Gras', 'Affiliation': 'Head and Neck Surgery Unit, Hôpital Saint-Joseph, Marseille, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Gillot', 'Affiliation': 'Head and Neck Surgery Unit, Hôpital Saint-Joseph, Marseille, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Turrin', 'Affiliation': 'General and Endocrine Surgery Unit, Hôpital Saint-Joseph, Marseille, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Penaranda', 'Affiliation': 'Biostatistic, Alphabio, Marseille, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Noullet', 'Affiliation': 'General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Chéreau', 'Affiliation': 'General and Endocrine Surgery Unit, Groupement Hospitalier Universitaire Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gaudart', 'Affiliation': ""Aix Marseille Université, Assistance Publique-Hôpitaux de Marseille, Institut National de la Santé et de la Recherche Médicale, L'Institut de Recherche Pour le Développement, Sciences Économiques et Sociales de la Santé et Traitement de L'information Médicale, Hôpital Timone, BioSTIC, Biostatistics & Information and Communication Technology, Marseille, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Chiche', 'Affiliation': 'Internal Medicine Unit, Hôpital Européen Marseille, Marseille, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Rebaudet', 'Affiliation': 'Internal Medicine Unit, Hôpital Européen Marseille, Marseille, France.'}]",JAMA surgery,['10.1001/jamasurg.2019.4613']
551,30352748,Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes.,"BACKGROUND & AIMS


Whether vitamin D affects lipid profile and cardiovascular disease (CVD) risk is controversial. We evaluated the effect of oral daily vitamin D supplementation on lipid profile and CVD risk in patients with well-controlled type 2 diabetes.
METHODS


Secondary analysis in the vitamin D for established type 2 diabetes (DDM2) study, a double-blind, randomized, placebo-controlled clinical trial. 127 patients (mean age 60 years) with stable (HbA1c ≤ 7.5%) diabetes managed with lifestyle only or lifestyle plus metformin were randomized to receive 4000 IU/day of vitamin D 3  (n = 66) or placebo (n = 61) for 48 weeks. Changes in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides [TG] and TG/HDL ratio), C-reactive protein and CVD risk (calculated according the American College of Cardiology/American Heart Association [ACC/AHA] guidelines) were assessed at week 24 and 48.
RESULTS


The mean [±SEM] plasma 25-hydroxyvitamin D [25(OH)D] level was higher in the vitamin D vs. the placebo group (20.5 ± 1.18 vs. -1.6 ± 1.2 ng/mL respectively; p < 0.001). There was no statistically significant change in lipid profile, C-reactive protein or CVD risk. Among patients who were not on cholesterol medication (n = 32), vitamin D supplementation reduced TG compared to placebo at week 48 (-18.74 ± 8.91 vs. 9.69 ± 8.60 mg/dL respectively; p = 0.032).
CONCLUSION


One year supplementation with vitamin D 3  at 4000 IU/day did not affect lipid profile, C-reactive protein and CVD risk in patients with stable type 2 diabetes not selected for vitamin D deficiency, with the exception of improvement of TG among patients not on cholesterol medication.
REGISTRATION


ClinicalTrials.gov Identifier NCT01736865.",2019,"There was no statistically significant change in lipid profile, C-reactive protein or CVD risk.","['patients with well-controlled type 2 diabetes', 'patients with stable type 2 diabetes', 'type 2 diabetes', '127 patients (mean age 60 years) with stable (HbA1c\xa0≤\xa07.5%) diabetes managed with lifestyle only or lifestyle plus metformin']","['vitamin D', 'vitamin D supplementation', 'placebo', 'oral daily vitamin D supplementation', 'vitamin D 3  (n\xa0=\xa066) or placebo']","['mean [±SEM] plasma 25-hydroxyvitamin D [25(OH)D] level', 'lipid profile and CVD risk', 'lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides [TG] and TG/HDL ratio), C-reactive protein and CVD risk (calculated according the American College of Cardiology/American Heart Association [ACC/AHA] guidelines', 'lipid profile, C-reactive protein and CVD risk', 'lipid profile, C-reactive protein or CVD risk', 'cardiovascular risk', 'lipid profile and cardiovascular disease (CVD) risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",127.0,0.526007,"There was no statistically significant change in lipid profile, C-reactive protein or CVD risk.","[{'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Angellotti', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, 800 Washington Street, #268, Boston, MA, 02111, USA. Electronic address: eangellotti@tuftsmedicalcenter.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Alessio"", 'Affiliation': ""Division of Endocrinology, Diabetes and Metabolism, Duke University, Durham, NC, 27710, USA. Electronic address: david.d'alessio@duke.edu.""}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, 800 Washington Street, #268, Boston, MA, 02111, USA; Bone Metabolism Laboratory, Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, 02111, USA. Electronic address: bess.dawson-hughes@tufts.edu.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'University of Kentucky College of Medicine, Lexington, KY, 40506, USA. Electronic address: ych228@uky.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Tufts Medical Center, Boston, MA, 02111, USA. Electronic address: jnelson2@tuftsmedicalcenter.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Cornell University, Ithaca, NY, 14850, USA. Electronic address: peterhu15412@gmail.com.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, University of Cincinnati College of Medicine and Cincinnati VA Medical Center, Cincinnati, OH, 45267-0547, USA. Electronic address: robert.cohen@uc.edu.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, 800 Washington Street, #268, Boston, MA, 02111, USA. Electronic address: apittas@tuftsmedicalcenter.org.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.10.003']
552,30665731,Effectiveness of DVD vs. group-initiated diabetes prevention on information uptake for high & low health literacy participants.,"OBJECTIVE


This study evaluates the effectiveness of technology versus in-person, group-initiated diabetes prevention to enhance comprehension of learning objectives between patients with differing health literacy (HL).
METHODS


Evidence-based content through either a DVD (n = 217) or in-person, group class (n = 225) to initiate the intervention. A teach-back call was used to assess comprehension of, and reinforce, learning objectives. Chi-squared was used to determine differences between conditions (DVD vs Class) and HL levels (High n = 361 vs. Low n = 81) and regression analyses were used to examine relationships.
RESULTS


DVD participants performed significantly better across teach back questions (15.4 ± 2.5 v. 14.8 ± 2.6, p < 0.01), demonstrated comprehension in fewer teach-back rounds (1.9 ± 0.7 v. 2.1 ± 0.7, p < 0.01), and answered more questions correctly on the first try (4.2 ± 1.6 v. 3.4 ± 1.8, p < 0.01). Models for HL levels and modality by HL level were statistically significant (p < 0.01) favoring the DVD.
CONCLUSION


Initiating a diabetes prevention program with the use of a DVD appears to be a superior option to in-person, class sessions. Teach-back and teach-to-goal strategies enables participants of both high and low health literacy levels to receive and confirm mastery of diabetes prevention objectives.
PRACTICE IMPLICATIONS


A teach-back call may improve information uptake increasing the likelihood of health behavior uptake.",2019,"Models for HL levels and modality by HL level were statistically significant (p < 0.01) favoring the DVD.
","['patients with differing health literacy (HL', 'Evidence-based content through either a DVD (n\u2009=\u2009217) or in-person, group class (n\u2009=\u2009225', 'high & low health literacy participants']","['DVD vs. group-initiated diabetes prevention', 'technology versus in-person, group-initiated diabetes prevention']","['HL levels', 'HL levels and modality by HL level', 'teach back questions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0262587,"Models for HL levels and modality by HL level were statistically significant (p < 0.01) favoring the DVD.
","[{'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Goessl', 'Affiliation': 'University of Nebraska Medical Center, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Estabrooks', 'Affiliation': 'University of Nebraska Medical Center, United States.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Virginia Tech, Blacksburg, Virginia, United States.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Britigan', 'Affiliation': 'University of Nebraska Medical Center, United States.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'DeAlba', 'Affiliation': 'University of Nebraska Medical Center, United States.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Almeida', 'Affiliation': 'University of Nebraska Medical Center, United States.'}]",Patient education and counseling,['10.1016/j.pec.2018.12.026']
553,31913424,Efficacy and Safety of Lumateperone for Treatment of Schizophrenia: A Randomized Clinical Trial.,"Importance


Individuals living with schizophrenia are affected by cardiometabolic, endocrine, and motor adverse effects of current antipsychotic medications. Lumateperone is a serotonin, dopamine, and glutamate modulator with the potential to treat schizophrenia with few adverse effects.
Objective


To examine the efficacy and safety of lumateperone for the short-term treatment of schizophrenia.
Design, Setting, and Participants


This randomized, double-blind, placebo-controlled, phase 3 clinical trial was conducted from November 13, 2014, to July 20, 2015, with data analyses performed from August 13 to September 15, 2015. Patients with schizophrenia who were aged 18 to 60 years and were experiencing an acute exacerbation of psychosis were enrolled from 12 clinical sites in the United States.
Interventions


Patients were randomized 1:1:1 (150 patients in each arm) to receive lumateperone tosylate, 60 mg; lumateperone tosylate, 40 mg (equivalent to 42 or 28 mg, respectively, of the active moiety lumateperone); or placebo once daily for 4 weeks.
Main Outcomes and Measures


The prespecified primary efficacy end point was mean change from baseline to day 28 in the Positive and Negative Syndrome Scale (PANSS) total score vs placebo. The key secondary efficacy measure was the Clinical Global Impression-Severity of Illness (CGI-S) score. The PANSS subscale scores, social function, safety, and tolerability were also assessed.
Results


The study comprised 450 patients (mean [SD] age, 42.4 [10.2] years; 346 [77.1%] male; mean [SD] baseline PANSS score, 89.8 [10.3]; mean [SD] baseline CGI-S score, 4.8 [0.6]). In the prespecified modified intent-to-treat efficacy analysis (n = 435), 42 mg of lumateperone met the primary and key secondary efficacy objectives, demonstrating a statistically significant improvement vs placebo from baseline to day 28 on the PANSS total score (least-squares mean difference [LSMD], -4.2; 95% CI, -7.8 to -0.6; P = .02; effect size [ES], -0.3) and the CGI-S (LSMD, -0.3; 95% CI, -0.5 to -0.1; P = .003; ES, -0.4). For 28 mg of lumateperone, the LSMD from baseline to day 28 was -2.6 (95% CI, -6.2 to 1.1; P = .16; ES, -0.2) on the PANSS total score and -0.2 (95% CI, -0.5 to 0.0; P = .02; ES, -0.3) on the CGI-S. Both lumateperone doses were well tolerated without clinically significant treatment-emergent motor adverse effects or changes in cardiometabolic or endocrine factors vs placebo.
Conclusions and Relevance


Lumateperone demonstrated efficacy for improving the symptoms of schizophrenia and had a favorable safety profile.
Trial Registration


ClinicalTrials.gov identifier: NCT02282761.",2020,"P = .16; ES, -0.2) on the PANSS total score and -0.2 (95% CI, -0.5 to 0.0; P = .02; ES, -0.3) on the CGI-S. Both lumateperone doses were well tolerated without clinically significant treatment-emergent motor adverse effects or changes in cardiometabolic or endocrine factors vs placebo.
","['Patients with schizophrenia who were aged 18 to 60 years and were experiencing an acute exacerbation of psychosis were enrolled from 12 clinical sites in the United States', '450 patients (mean [SD] age, 42.4 [10.2] years; 346 [77.1%] male; mean [SD] baseline PANSS score, 89.8 [10.3]; mean [SD] baseline CGI-S score, 4.8 [0.6', 'November 13, 2014, to July 20, 2015, with data analyses performed from August 13 to September 15, 2015', 'Schizophrenia']","['placebo', 'lumateperone tosylate, 60 mg; lumateperone tosylate', 'Lumateperone', 'lumateperone']","['efficacy and safety', 'Clinical Global Impression-Severity of Illness (CGI-S) score', 'Efficacy and Safety', 'mean change from baseline to day 28 in the Positive and Negative Syndrome Scale (PANSS) total score', 'PANSS total score', 'PANSS subscale scores, social function, safety, and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C4517519', 'cui_str': 'Ten point three'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",450.0,0.538683,"P = .16; ES, -0.2) on the PANSS total score and -0.2 (95% CI, -0.5 to 0.0; P = .02; ES, -0.3) on the CGI-S. Both lumateperone doses were well tolerated without clinically significant treatment-emergent motor adverse effects or changes in cardiometabolic or endocrine factors vs placebo.
","[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Davis', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weingart', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Saillard', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': ""O'Gorman"", 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York Presbyterian Hospital, New York.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Tamminga', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Mates', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Vanover', 'Affiliation': 'Intra-Cellular Therapies Inc, New York, New York.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4379']
554,31992407,Risk of excessive sleepiness in sleep restriction therapy and cognitive behavioral therapy for insomnia: a randomized controlled trial.,"STUDY OBJECTIVES


Sleep restriction therapy (SRT) has been shown to be comparably effective relative to cognitive behavioral therapy for insomnia (CBT-I), but with lower requirements for patient contact. As such, SRT appears to be a viable alternate treatment for those who cannot complete a full course of CBT-I. However, it is unclear whether SRT-a treatment solely focusing on restricting time in bed-increases risk for sleepiness comparably to CBT-I. The current study tested objective sleepiness as an outcome in a randomized controlled trial comparing SRT, CBT-I, and attention control in a sample of postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.
METHODS


Single-site, randomized controlled trial. A total of 150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder were randomized to 3 treatment conditions: sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions). Blinded assessments were performed at pretreatment and posttreatment. Risk of excessive sleepiness was evaluated using a symmetry analysis of sleepiness measured through the Multiple Sleep Latency Test (MSLT).
RESULTS


The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy. This suggests that excessive sleepiness is not of unique concern following SRT relative to CBT-I or sleep education.
CONCLUSIONS


SRT appears to have a comparable risk profile for excessive sleepiness as CBT-I, and thus may be considered a safe alternative to CBT-I. Future research should characterize objective measures of excessive sleepiness immediately following sleep restriction.
CLINICAL TRAIL REGISTRATION


Registry: ClinicalTrials.gov; Name: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295.",2020,"The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy.","['insomnia', 'postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition', '150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder']","['sleep restriction therapy and cognitive behavioral therapy', 'SRT', 'Sleep restriction therapy (SRT', 'sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions']","['Risk of excessive sleepiness', 'odds ratios (ORs) of being excessively sleepy versus nonsleepy']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy (regime/therapy)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}]",150.0,0.0429993,"The odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Fellman-Couture', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders and Research Center, Henry Ford Health System, Detroit, Michigan.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8164']
555,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES


To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS


This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS


Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2  provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION


Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2  provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
556,31761958,"Topical rapamycin reduces markers of senescence and aging in human skin: an exploratory, prospective, randomized trial.","Aging is a major risk factor for the majority of human diseases, and the development of interventions to reduce the intrinsic rate of aging is expected to reduce the risk for age-related diseases including cardiovascular disease, cancer, and dementia. In the skin, aging manifests itself in photodamage and dermal atrophy, with underlying tissue reduction and impaired barrier function. To determine whether rapamycin, an FDA-approved drug targeting the mechanistic target of rapamycin (mTOR) complex, can reduce senescence and markers of aging in human skin, an exploratory, placebo-controlled, interventional trial was conducted in a clinical dermatology setting. Participants were greater than 40 years of age with evidence of age-related photoaging and dermal volume loss and no major morbidities. Thirty-six participants were enrolled in the study, and nineteen discontinued or were lost to follow-up. A significant (P = 0.008) reduction in p16 INK4A  protein levels and an increase in collagen VII protein levels (P = 0.0077) were observed among participants at the end of the study. Clinical improvement in skin appearance was noted in multiple participants, and immunohistochemical analysis revealed improvement in histological appearance of skin tissue. Topical rapamycin reduced the expression of the p16 INK4A  protein consistent with a reduction in cellular senescence. This change was accompanied by relative improvement in clinical appearance of the skin and histological markers of aging and by an increase in collagen VII, which is critical to the integrity of the basement membrane. These results indicate that rapamycin treatment is a potential anti-aging therapy with efficacy in humans.Trial registration ClinicalTrials.gov Identifier: NCT03103893.",2019,A significant (P = 0.008) reduction in p16 INK4A  protein levels and an increase in collagen VII protein levels (P = 0.0077) were observed among participants at the end of the study.,"['Participants were greater than 40 years of age with evidence of age-related photoaging and dermal volume loss and no major morbidities', 'human skin', 'Thirty-six participants were enrolled in the study, and nineteen discontinued or were lost to follow-up']","['rapamycin', 'Topical rapamycin']","['histological appearance of skin tissue', 'skin appearance', 'collagen VII protein levels']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0684084', 'cui_str': 'Skin tissue'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",36.0,0.0435227,A significant (P = 0.008) reduction in p16 INK4A  protein levels and an increase in collagen VII protein levels (P = 0.0077) were observed among participants at the end of the study.,"[{'ForeName': 'Christina Lee', 'Initials': 'CL', 'LastName': 'Chung', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ibiyonu', 'Initials': 'I', 'LastName': 'Lawrence', 'Affiliation': 'Department of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Dareen', 'Initials': 'D', 'LastName': 'Elgindi', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Nadhan', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Potnis', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Catlin', 'Initials': 'C', 'LastName': 'Sershon', 'Affiliation': 'Department of Dermatology, Drexel University College of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Binnebose', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Lorenzini', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sell', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, 245 N 15th Street, Philadelphia, PA, 19102, USA. cs389@drexel.edu.'}]",GeroScience,['10.1007/s11357-019-00113-y']
557,32146074,"The Effects of Intraoperative Progressive Muscle Relaxation and Virtual Reality Application on Anxiety, Vital Signs, and Satisfaction: A Randomized Controlled Trial.","PURPOSE


This study aimed to determine the effects of intraoperative progressive muscle relaxation (PMR) and the application of virtual reality (VR) on anxiety, vital signs, and satisfaction levels during a knee arthroscopy operation.
DESIGN


The study was a three-group randomized controlled trial.
METHODS


This study was conducted with 93 patients who consented to participate in the study.
FINDINGS


The State-Trait Anxiety Inventory-S anxiety scale (STAI-S) scores were increased in all the three groups after the surgery. When the preoperative and postoperative STAI-S scores in the group were examined; intragroup STAI-S scores in the PMR and VR groups were statistically significant (P < .05). There was a significant difference between the control group and the PMR and VR groups in mean satisfaction scores (P < .05). The differences between blood pressure and pulse rate were statistically significant in the PMR and VR groups (P < .05).
CONCLUSIONS


Intraoperative PMR and VR can be used as nursing interventions to increase satisfaction and positively affect vital signs in patients who undergo surgery with spinal anesthesia.",2020,"The differences between blood pressure and pulse rate were statistically significant in the PMR and VR groups (P < .05).
","['patients who undergo surgery with spinal anesthesia', '93 patients who consented to participate in the study']","['intraoperative progressive muscle relaxation (PMR', 'virtual reality (VR', 'Intraoperative Progressive Muscle Relaxation and Virtual Reality Application']","['Anxiety, Vital Signs, and Satisfaction', 'anxiety, vital signs, and satisfaction levels', 'mean satisfaction scores', 'preoperative and postoperative STAI-S scores', 'blood pressure and pulse rate', 'State-Trait Anxiety Inventory-S anxiety scale (STAI-S) scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518766'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}]",93.0,0.0197409,"The differences between blood pressure and pulse rate were statistically significant in the PMR and VR groups (P < .05).
","[{'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Sahin', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Training and Research Hospital, Ankara. Electronic address: sahingl@gmail.com.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Ankara.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.11.002']
558,30360984,"A double-blind placebo controlled trial into the impacts of HMB supplementation and exercise on free-living muscle protein synthesis, muscle mass and function, in older adults.","Age-related sarcopenia and dynapenia are associated with frailty and metabolic diseases. Resistance exercise training (RET) adjuvant to evidence-based nutritional intervention(s) have been shown as mitigating strategies. Given that β-hydroxy-β-methyl-butyrate (HMB) supplementation during RET improves lean body mass in younger humans, and that we have shown that HMB acutely stimulates muscle protein synthesis (MPS) and inhibits breakdown; we hypothesized that chronic supplementation of HMB free acid (HMB-FA) would enhance MPS and muscle mass/function in response to RET in older people. We recruited 16 healthy older men (Placebo (PLA): 68.5 ± 1.0 y, HMB-FA: 67.8 ± 1.15 y) for a randomised double-blind-placebo controlled trial (HMB-FA 3 × 1 g/day vs. PLA) involving a 6-week unilateral progressive RET regime (6 × 8 repetitions, 75% 1-RM, 3 · wk -1 ). Deuterium oxide (D 2 O) dosing was performed over the first two weeks (0-2 wk) and last two weeks (4-6 wk) with bilateral vastus lateralis (VL) biopsies at 0-2 and 4-6 wk (each time 75 ± 2 min after a single bout of resistance exercise (RE)) for quantification of early and later MPS responses and post-RE myogenic gene expression. Thigh lean mass (TLM) was measured by DXA, VL thickness and architecture (fibre length and pennation angle) by ultrasound at 0/3/6 wk, and strength by knee extensor 1-RM testing and MVC by isokinetic dynamometry (approx. every 10 days). RET induced strength increases (1-RM) in the exercised leg of both groups (398 ± 22N to 499 ± 30N HMB-FA vs. 396 ± 29N to 510 ± 43N PLA (both P < 0.05)). In addition, maximal voluntary contraction (MVC) also increased (179 ± 12 Nm to 203 ± 12 Nm HMB-FA vs. 185 ± 10 Nm to 217 ± 11 Nm PLA (both P < 0.05); with no group differences. VL muscle thickness increased significantly in the exercised leg in both groups, with no group differences. TLM (by DXA) rose to significance only in the HMB-FA group (by 5.8%-5734 ± 245 g p = 0.015 vs. 3.0% to 5644 ± 323 g P = 0.06 in PLA). MPS remained unchanged in the untrained legs (UT) 0-2 weeks being 1.06 ± 0.08%.d -1  (HMB-FA) and 1.14 ± 0.09%.d -1  (PLA), the trained legs (T) exhibited increased MPS in the HMB-FA group only at 0-2-weeks (1.39 ± 0.10%.d -1 , P < 0.05) compared with UT: but was not different at 4-6-weeks: 1.26 ± 0.05%.d -1 . However, there were no significant differences in MPS between the HMB-FA and PLA groups at any given time point and no significant treatment interaction observed. We also observed significant inductions of c-Myc gene expression following each acute RE bout, with no group differences. Further, there were no changes in any other muscle atrophy/hypertrophy or myogenic transcription factor genes we measured. RET with adjuvant HMB-FA supplements in free-living healthy older men did not enhance muscle strength or mass greater than that of RET alone (PLA). That said, only HMB-FA increased TLM, supported by early increases in chronic MPS. As such, chronic HMB-FA supplementation may result in long term benefits in older males, however longer and larger studies may be needed to fully determine the potential effects of HMB-FA supplementation; translating to any functional benefit.",2019,RET with adjuvant HMB-FA supplements in free-living healthy older men did not enhance muscle strength or mass greater than that of RET alone (PLA).,"['16 healthy older men (Placebo (PLA): 68.5\xa0±\xa01.0\xa0y, HMB-FA: 67.8\xa0±', 'Nm to 203\xa0±\xa012', '10', 'free-living healthy older men', 'older males', 'older adults', 'younger humans', '245', 'Nm to 217\xa0±']","['Resistance exercise training (RET) adjuvant to evidence-based nutritional intervention(s', 'placebo', 'HMB supplementation and exercise', 'UT', 'bilateral vastus lateralis (VL', 'TLM', 'β-hydroxy-β-methyl-butyrate (HMB) supplementation', 'Deuterium oxide (D 2 O', 'RET with adjuvant HMB-FA supplements']","['Thigh lean mass (TLM', 'MPS', 'muscle atrophy/hypertrophy or myogenic transcription factor genes', 'chronic MPS', 'RET induced strength increases (1-RM', 'VL muscle thickness', 'lean body mass', 'maximal voluntary contraction (MVC']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0066231', 'cui_str': 'methyl butyrate'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040648'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}]",16.0,0.0731942,RET with adjuvant HMB-FA supplements in free-living healthy older men did not enhance muscle strength or mass greater than that of RET alone (PLA).,"[{'ForeName': 'U S U', 'Initials': 'USU', 'LastName': 'Din', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Brook', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Selby', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Quinlan', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boereboom', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Abdulla', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Franchi', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Narici', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Williams', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Rathmacher', 'Affiliation': 'Metabolic Technologies, Inc, Iowa State University Research Park, 2711 S. Loop Drive, Ste 4400, Ames, IA, 50010, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Wilkinson', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK. Electronic address: ken.smith@nottingham.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.09.025']
559,29347863,An Intervention to Improve Physical Function and Caregiver Perceptions in Family Caregivers of Persons With Heart Failure.,"Objective:  This randomized controlled trial was conducted to determine whether a 12-week home-based aerobic and resistance exercise program would improve physical function and caregiving perceptions among family caregivers (FCGs) of persons with heart failure.  Method:  Overall, 127 FCGs were randomized to one of three groups: usual care attention control (UCAC), psychoeducation only (PE), and psychoeducation plus exercise (PE + EX). Physical function measures (6-min walk test, handgrip, and upper and lower strength) and caregiving perceptions (Bakas Caregiving Outcomes Scale) were obtained at baseline and at 6 months.  Results:  FCGs in the PE + EX showed significant improvement in 6-min walk distance ( p  = .012), handgrip, and lower extremity strength compared with the PE and UCAC groups. The combined group had the greatest improvement in caregiver perceptions ( p  < .001).  Conclusion:  FCGs in the PE + EX group improved the most in physical function and caregiver perception outcomes. Directions for future research are provided.",2020,"RESULTS


FCGs in the PE + EX showed significant improvement in 6-min walk distance ( p = .012), handgrip, and lower extremity strength compared with the PE and UCAC groups.","['Family Caregivers of Persons With Heart Failure', '127 FCGs', 'family caregivers (FCGs) of persons with heart failure']","['home-based aerobic and resistance exercise program', 'PE + EX', 'usual care attention control (UCAC), psychoeducation only (PE), and psychoeducation plus exercise (PE + EX']","['6-min walk distance', 'physical function and caregiver perception outcomes', 'Physical function measures (6-min walk test, handgrip, and upper and lower strength) and caregiving perceptions (Bakas Caregiving Outcomes Scale', 'caregiver perceptions', 'handgrip, and lower extremity strength', 'physical function and caregiving perceptions', 'Physical Function and Caregiver Perceptions']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",127.0,0.0444537,"RESULTS


FCGs in the PE + EX showed significant improvement in 6-min walk distance ( p = .012), handgrip, and lower extremity strength compared with the PE and UCAC groups.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gary', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing (NHWSON), Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing (NHWSON), Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing (NHWSON), Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Butts', 'Affiliation': 'Department of Cardiovascular Disease, University of Alabama, Birmingham, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corwin', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing (NHWSON), Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Hepburn', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing (NHWSON), Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Stonybrook Medical Center, Long Island, NY, USA.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Emory University, Atlanta, GA, USA.'}]",Journal of applied gerontology : the official journal of the Southern Gerontological Society,['10.1177/0733464817746757']
560,31721978,Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial.,"Importance


The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) cluster-randomized trial found that copayment reduction for P2Y12 inhibitors improved 1-year patient persistence in taking that medication.
Objective


To assess whether providing copayment reduction for P2Y12 inhibitors increases patient persistence in taking other secondary prevention cardiovascular medications.
Design, Setting, and Participants


This post hoc analysis of the ARTEMIS trial includes data from 287 hospitals that enrolled patients between June 2015 and September 2016. Patients hospitalized with acute myocardial infarction were included. Data analysis occurred from May 2018 through August 2019.
Interventions


Hospitals randomized to the intervention provided patients vouchers that waived copayments for P2Y12 inhibitors fills for 1 year. Hospitals randomized to usual care did not provide study vouchers.
Main Outcomes and Measures


Persistence in taking β-blocker, statin, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker medications at 1 year, defined as the absence of a gap in medication supply of 30 or more days by pharmacy fill data in the intervention-arm (intent-to-treat) population.
Results


A total of 131 hospitals (with 5109 patients) were randomized to the intervention, and 156 hospitals (with 3264 patients) randomized to the control group. Patients discharged from intervention hospitals had higher persistence in taking statins (2247 [46.1%] vs 1300 [41.9%]; adjusted odds ratio, 1.11 [95% CI, 1.00-1.24]), and β-blockers (2235 [47.6%] vs 1277 [42.5%]; odds ratio, 1.23 [95% CI, 1.10-1.38]), although the association was smaller than that seen for P2Y12 inhibitors (odds ratio, 1.47 [95% CI, 1.29-1.66]). Persistence in taking angiotensin-converting enzyme inhibitors or angiotensin II-receptor blockers were also numerically higher among patients in the intervention arm than in the usual-care arm, but this was not significant after risk adjustment (1520 [43.9%] vs 847 [40.5%]; adjusted odds ratio, 1.10 [95% CI, 0.97-1.24]). Patients in the intervention arm reported greater financial burden associated with medication cost than the patients in the usual-care arm at baseline, but these differences were no longer significant at 1 year.
Conclusions and Relevance


Reducing patient copayments for 1 medication class increased persistence not only to that therapy class but may also have modestly increased persistence to other post-myocardial infarction secondary prevention medications. These findings have important implications for the clinical utility and cost-effectiveness of medication cost-assistance programs.
Trial Registration


ClinicalTrials.gov identifier: NCT02406677.",2020,"Patients in the intervention arm reported greater financial burden associated with medication cost than the patients in the usual-care arm at baseline, but these differences were no longer significant at 1 year.
","['287 hospitals that enrolled patients between June 2015 and September 2016', 'A total of 131 hospitals (with 5109 patients) were randomized to the intervention, and 156 hospitals (with 3264 patients) randomized to the control group', 'Patients hospitalized with acute myocardial infarction']","['P2Y12 Inhibitor Copayment Reduction Intervention', 'intervention provided patients vouchers that waived copayments for P2Y12 inhibitors fills for 1 year', 'P2Y12 inhibitors']","['1-year patient persistence', 'higher persistence in taking statins', 'financial burden associated with medication cost', 'Measures\n\n\nPersistence in taking β-blocker, statin, and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker medications at 1 year, defined as the absence of a gap in medication supply of 30 or more days by pharmacy fill data']","[{'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}]",3264.0,0.121541,"Patients in the intervention arm reported greater financial burden associated with medication cost than the patients in the usual-care arm at baseline, but these differences were no longer significant at 1 year.
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Fanaroff', 'Affiliation': 'Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, Ohio.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Fonseca', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Wilmington, Delaware.'}, {'ForeName': 'Naeem D', 'Initials': 'ND', 'LastName': 'Khan', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Wilmington, Delaware.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Ronald Reagan-UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2019.4408']
561,31320350,The effect of smell and taste of milk during tube feeding of preterm infants (the Taste trial): a protocol for a randomised controlled trial.,"INTRODUCTION


Smell and taste of milk are not generally considered when tube feeding preterm infants. Preterm infants have rapid growth, particularly of the brain, and high caloric needs. Enteral feeding is often poorly tolerated which may lead to growth failure and long-term neurodevelopmental impairment. Smell and taste are strong stimulators of digestion and metabolism. We hypothesise that regular smell and taste during tube feeding will improve weight z-scores of very preterm infants at discharge from hospital.
METHODS AND ANALYSIS


Taste is a randomised, unblinded two-centre trial. Infants born at <29 weeks' gestation and/or <1250 g at birth and admitted to a participating neonatal intensive care unit are eligible. Randomisation occurs before infants receive two hourly feeds for 24 hours. Infants are randomised to either smell and taste of milk with each tube feed or tube feeding without the provision of smell and taste. The primary outcome is weight z-score at discharge. Secondary outcomes include: days to full enteral feeds, duration of parenteral nutrition, rate of late-onset sepsis, post menstrual age at removal of nasogastric tube and at discharge from hospital, anthropometric data and neurodevelopmental outcomes at 2 years of corrected age.
ETHICS AND DISSEMINATION


Human Research Ethics Committees of Mater Misericordiae (trial reference number: HREC/16/MHS/112) and the Royal Women's Hospital (trial reference number: 17/21) last approved the trial protocol (version 4.2; Date: 18 December 2018) and recruitment commenced in May 2017 and November 2017, respectively. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


ACTRN12617000583347.",2019,Infants are randomised to either smell and taste of milk with each tube feed or tube feeding without the provision of smell and taste.,"['tube feeding preterm infants', ""Infants born at <29 weeks' gestation and/or <1250\u2009g at birth and admitted to a participating neonatal intensive care unit are eligible"", 'very preterm infants at discharge from hospital', 'preterm infants (the Taste trial', ""Human Research Ethics Committees of Mater Misericordiae (trial reference number: HREC/16/MHS/112) and the Royal Women's Hospital (trial reference number: 17/21""]","['smell and taste of milk', 'smell and taste of milk with each tube feed or tube feeding without the provision of smell and taste']","[' days to full enteral feeds, duration of parenteral nutrition, rate of late-onset sepsis, post menstrual age at removal of nasogastric tube and at discharge from hospital, anthropometric data and neurodevelopmental outcomes at 2\u2009years of corrected age', 'weight z-score at discharge', 'weight z-scores']","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086911', 'cui_str': 'Institutional Review Boards'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0204823', 'cui_str': 'Nasogastric tube removal (procedure)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.35117,Infants are randomised to either smell and taste of milk with each tube feed or tube feeding without the provision of smell and taste.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Beker', 'Affiliation': 'Mater Research Institute, University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Macey', 'Affiliation': 'Mater Research Institute, University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Liley', 'Affiliation': 'Mater Research Institute, University of Queensland, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Hughes', 'Affiliation': 'Office for Research Governance and Development, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Davis', 'Affiliation': ""Neonatal Intensive Care Unit and Newborn Research, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Twitchell', 'Affiliation': 'Clinical Sciences Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jacobs', 'Affiliation': ""Neonatal Intensive Care Unit and Newborn Research, The Royal Women's Hospital, Melbourne, Victoria, Australia.""}]",BMJ open,['10.1136/bmjopen-2018-027805']
562,31254451,Racial Differences in Performance-Based Function and Potential Explanatory Factors Among Individuals With Knee Osteoarthritis.,"OBJECTIVE


In individuals with knee osteoarthritis (OA), self-reported physical function is poorer in African Americans than in whites, but whether this difference holds true for objective assessments is unclear. The purpose of this study was to examine racial differences in performance-based physical function as well as potential underlying factors contributing to these racial differences.
METHODS


Participants with knee OA from a randomized controlled trial completed the 2-minute step test (2MST), timed-up-and-go (TUG), and 30-second chair stand (30s-CST) at baseline. Race differences in performance-based function were assessed by logistic regression. Separate models were adjusted for sets of demographic, socioeconomic, psychological health, and physical health variables.
RESULTS


In individuals with knee OA (n = 322; 72% women, 22% African American, mean ± SD age 66 ± 11 years, mean ± SD body mass index 31 ± 8 kg/m 2  ), African Americans (versus whites) had greater unadjusted odds of poorer function (30s-CST odds ratio [OR] 2.79 [95% confidence interval (95% CI) 1.65-4.72], 2MST OR 2.37 [95% CI 1.40-4.03], and TUG OR 3.71 [95% CI 2.16-6.36]). Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or nonsignificant when adjusted for physical health and socioeconomic covariates.
CONCLUSION


African American adults with knee OA had poorer unadjusted performance-based function than whites. Physical health and socioeconomic characteristics diminished these differences, emphasizing the fact that these factors may be important to consider in mitigating racial disparities in function.",2020,"Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or non-significant when adjusted for physical health and socioeconomic covariates.
","['Participants with knee OA', 'persons with knee OA (n=322; women: 72%, Black: 22%, age=66±11 years, BMI=31±8 kg/m 2  ), Blacks (vs. Whites) had greater unadjusted odds of poorer function (30s-CST: OR [95% CI] = 2.79 [1.65-4.72', 'people with knee osteoarthritis (OA', 'individuals with knee osteoarthritis']","['2MST', '2-minute step tests (2MST), timed-up-and-go (TUG), and 30-second chair stands']",[],"[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",[],322.0,0.120359,"Relationships were maintained when adjusted for demographic and psychological health covariates, but they were either partially attenuated or non-significant when adjusted for physical health and socioeconomic covariates.
","[{'ForeName': 'Portia P E', 'Initials': 'PPE', 'LastName': 'Flowers', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Schwartz', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Yvonne M', 'Initials': 'YM', 'LastName': 'Golightly', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'Comprehensive Physical Therapy Center, Chapel Hill, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jyotsna J', 'Initials': 'JJ', 'LastName': 'Gupta', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Leigh F', 'Initials': 'LF', 'LastName': 'Callahan', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Goode', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Corsi', 'Affiliation': 'Northeastern Ohio Medical University, Rootstown, Ohio.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'University of North Carolina at Chapel Hill and Durham VA Medical Center, Durham, North Carolina.'}]",Arthritis care & research,['10.1002/acr.24018']
563,31651843,Yoga and schizophrenia-a comprehensive assessment of neuroplasticity: Protocol for a single blind randomized controlled study of yoga in schizophrenia.,"INTRODUCTION


Schizophrenia is one of the most severe mental disorders with a prevalence of about 1% and a leading cause of disability among young adults. Pharmacotherapy is the mainstay in the management of schizophrenia. However, even with the best of medication, several problems like refractoriness, negative symptoms, frequent relapses, and cognitive impairments persist.
METHODS


This is a randomized-controlled clinical study including patients from an urban tertiary hospital and a semi-urban community center, with a between-group, repeated-measures, longitudinal design. This study will recruit 160 patients with DSM 5 diagnosis of schizophrenia who are on stable medication for a minimum of 6 weeks; they will be randomly assigned into 2 arms viz., yoga therapy (YT), and treatment-as-usual (TAU) with 80 patients in each arm. Participants will undergo Clinical, Laboratory, and Radiological assessments at baseline and at intervals of 1 month, 3 months, and 6 months from the baseline. It is hypothesized that yoga will improve psychopathology and emotion processing, increase serum brain derived neurotrophic factor (BDNF) and plasma oxytocin levels and effect changes in cerebral activation in areas of the brain associated with schizophrenia.
DISCUSSION


This study aims to measure the efficacy of a Yoga-based intervention as an adjunct in patients with schizophrenia as well as the mechanisms of these effects.
TRIAL REGISTRATION


Registered retrospectively with Clinical Trial Registry - India (CTRI) with registration number CTRI/2017/08/009219.",2019,", yoga therapy (YT), and treatment-as-usual (TAU) with 80 patients in each arm.","['young adults', 'patients from an urban tertiary hospital and a semi-urban community center, with a between-group, repeated-measures, longitudinal design', '160 patients with DSM 5 diagnosis of schizophrenia who are on stable medication for a minimum of 6 weeks', 'patients with schizophrenia']","['Pharmacotherapy', 'Yoga-based intervention', 'yoga therapy (YT), and treatment-as-usual (TAU']","['psychopathology and emotion processing, increase serum brain derived neurotrophic factor (BDNF) and plasma oxytocin levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",160.0,0.0910744,", yoga therapy (YT), and treatment-as-usual (TAU) with 80 patients in each arm.","[{'ForeName': 'Shivarama', 'Initials': 'S', 'LastName': 'Varambally', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Venkatasubramanian', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Ramajayam', 'Initials': 'R', 'LastName': 'Govindaraj', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Venkataram', 'Initials': 'V', 'LastName': 'Shivakumar', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Thrinath', 'Initials': 'T', 'LastName': 'Mullapudi', 'Affiliation': 'Department of Human Genetics.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Christopher', 'Affiliation': 'Department of Neurochemistry.'}, {'ForeName': 'Monojit', 'Initials': 'M', 'LastName': 'Debnath', 'Affiliation': 'Department of Human Genetics.'}, {'ForeName': 'Mariamma', 'Initials': 'M', 'LastName': 'Philip', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Rose Dawn', 'Initials': 'RD', 'LastName': 'Bharath', 'Affiliation': 'Department of Neuroimaging and Interventional Radiology, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'B N', 'Initials': 'BN', 'LastName': 'Gangadhar', 'Affiliation': 'Department of Psychiatry.'}]",Medicine,['10.1097/MD.0000000000017399']
564,31033434,Adalimumab in combination with methotrexate for refractory uveitis associated with juvenile idiopathic arthritis: a RCT.,"BACKGROUND


Children with juvenile idiopathic arthritis (JIA) are at risk of uveitis. The role of adalimumab (Humira ® ; AbbVie Inc., Ludwigshafen, Germany) in the management of uveitis in children needs to be determined.
OBJECTIVE


To compare the efficacy, safety and cost-effectiveness of adalimumab in combination with methotrexate (MTX) versus placebo with MTX alone, with regard to controlling disease activity in refractory uveitis associated with JIA.
DESIGN


This was a randomised (applying a ratio of 2 : 1 in favour of adalimumab), double-blind, placebo-controlled, multicentre parallel-group trial with an integrated economic evaluation. A central web-based system used computer-generated tables to allocate treatments. A cost-utility analysis based on visual acuity was conducted and a 10-year extrapolation by Markov modelling was also carried out.
SETTING


The setting was tertiary care centres throughout the UK.
PARTICIPANTS


Patients aged 2-18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks).
INTERVENTIONS


All participants received a stable dose of MTX and either adalimumab (20 mg/0.8 ml for patients weighing < 30 kg or 40 mg/0.8 ml for patients weighing ≥ 30 kg by subcutaneous injection every 2 weeks based on body weight) or a placebo (0.8 ml as appropriate according to body weight by subcutaneous injection every 2 weeks) for up to 18 months. A follow-up appointment was arranged at 6 months.
MAIN OUTCOME MEASURES


Primary outcome - time to treatment failure [multicomponent score as defined by set criteria based on the Standardisation of Uveitis Nomenclature (SUN) criteria]. Economic outcome - incremental cost per quality-adjusted life-year (QALY) gained from the perspective of the NHS in England and Personal Social Services providers. Full details of secondary outcomes are provided in the study protocol.
RESULTS


A total of 90 participants were randomised (adalimumab,  n  = 60; placebo,  n  = 30). There were 14 (23%) treatment failures in the adalimumab group and 17 (57%) in the placebo group. The analysis of the data from the double-blind phase of the trial showed that the hazard risk (HR) of treatment failure was significantly reduced, by 75%, for participants in the adalimumab group (HR 0.25, 95% confidence interval 0.12 to 0.51;  p  < 0.0001 from log-rank test). The cost-effectiveness of adalimumab plus MTX was £129,025 per QALY gained. Adalimumab-treated participants had a much higher incidence of adverse and serious adverse events.
CONCLUSIONS


Adalimumab in combination with MTX is safe and effective in the management of JIA-associated uveitis. However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold.
FUTURE WORK


A clinical trial is required to define the most effective time to stop therapy. Prognostic biomarkers of early and complete response should also be identified.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN10065623 and European Clinical Trials Database number 2010-021141-41.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 15. See the NIHR Journals Library website for further project information. This trial was also funded by Arthritis Research UK (grant reference number 19612). Two strengths of adalimumab (20 mg/0.8 ml and 40 mg/0.8 ml) and a matching placebo were manufactured by AbbVie Inc. (the Marketing Authorisation holder) and supplied in bulk to the contracted distributor (Sharp Clinical Services, Crickhowell, UK) for distribution to trial centres.",2019,"However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold.
","['refractory uveitis associated with juvenile idiopathic arthritis', 'refractory uveitis associated with JIA', 'Children with juvenile idiopathic arthritis (JIA', 'Patients aged 2-18 years inclusive, with persistently active JIA-associated uveitis (despite optimised MTX treatment for at least 12 weeks', 'A total of 90 participants were randomised']","['methotrexate', 'methotrexate (MTX', 'placebo', 'placebo with MTX', 'adalimumab', 'Adalimumab', 'adalimumab,  n \u2009=\u200960; placebo', 'adalimumab plus MTX', 'MTX', 'adalimumab (Humira ® ; AbbVie Inc., Ludwigshafen, Germany']","[' time to treatment failure [multicomponent score as defined by set criteria based on the Standardisation of Uveitis Nomenclature (SUN) criteria', 'adverse and serious adverse events', 'hazard risk (HR) of treatment failure', 'Economic outcome - incremental cost per quality-adjusted life-year (QALY', 'cost-effectiveness', 'efficacy, safety and cost-effectiveness']","[{'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C3495559', 'cui_str': 'Arthritis, Juvenile Chronic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1171255', 'cui_str': 'Humira'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0600281', 'cui_str': 'Nomenclature'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.518771,"However, the likelihood of cost-effectiveness is < 1% at the £30,000-per-QALY threshold.
","[{'ForeName': 'Athimalaipet V', 'Initials': 'AV', 'LastName': 'Ramanan', 'Affiliation': 'Department of Paediatric Rheumatology, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Dick', 'Affiliation': 'Bristol Eye Hospital, Bristol, UK.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Jones', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKay', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Hardwick', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Culeddu', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Catrin', 'Initials': 'C', 'LastName': 'Plumpton', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Eifiona', 'Initials': 'E', 'LastName': 'Wood', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Compeyrot-Lacassagne', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Woo', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Edelsten', 'Affiliation': 'Great Ormond Street Hospital, London, UK.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Beresford', 'Affiliation': ""Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23150']
565,29587530,"A multilevel examination of sleep, depression, and quality of life in people living with HIV/AIDS.","Sleep problems are prevalent in people living with HIV/AIDS; however, few studies examine how poor sleep affects mental health and quality of life longitudinally. A sample of people living with HIV/AIDS from a randomized trial ( N  = 240; mean age = 47.18; standard deviation = 8.3; 71.4% male; 61.2% White) completed measures of depression (Montgomery-Åsberg Depression Rating Scale), health-related quality of life (AIDS Clinical Trial Group Quality of Life Measure), and life satisfaction (Quality of Life Inventory) at baseline and 4, 8, and 12 months. Controlling for time, condition, and relevant interactions, sleep problems significantly predicted worse outcomes over time ( p s < 0.001). Findings have implications for the importance of identifying and treating sleep problems in people living with HIV/AIDS to improve mental health and quality-of-life outcomes.",2020,"Controlling for time, condition, and relevant interactions, sleep problems significantly predicted worse outcomes over time ( ps < 0.001).","['people living with HIV/AIDS', 'people living with HIV/AIDS from a randomized trial ( N\u2009=\u2009240; mean age\u2009=\u200947.18; standard deviation\u2009=\u20098.3; 71.4% male; 61.2% White) completed']",[],"['measures of depression (Montgomery-Åsberg Depression Rating Scale), health-related quality of life (AIDS Clinical Trial Group Quality of Life Measure), and life satisfaction (Quality of Life Inventory', 'sleep, depression, and quality of life']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517833', 'cui_str': '61.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1320290', 'cui_str': 'Clinical trial group'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",,0.140617,"Controlling for time, condition, and relevant interactions, sleep problems significantly predicted worse outcomes over time ( ps < 0.001).","[{'ForeName': 'Brooke G', 'Initials': 'BG', 'LastName': 'Rogers', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Jasper S', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Sierra A', 'Initials': 'SA', 'LastName': 'Bainter', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'C Andres', 'Initials': 'CA', 'LastName': 'Bedoya', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Pinkston', 'Affiliation': 'The Warren Alpert Medical School of Brown University, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'University of Miami, USA.'}]",Journal of health psychology,['10.1177/1359105318765632']
566,29649914,Positive affect skills may improve pain management in people with HIV.,"Non-opioid pain management strategies are critically needed for people with HIV. We therefore conducted a secondary analysis of pain-related outcomes in a randomized controlled trial of a positive affect skills intervention for adults newly diagnosed with HIV ( N  = 159). Results suggest that, even if pain prevalence rises, positive affect skills may reduce pain interference and prevent increased use of opioid analgesics by people living with HIV. Future research should replicate and extend these findings by conducting trials that are specifically designed to target pain outcomes.",2020,"Results suggest that, even if pain prevalence rises, positive affect skills may reduce pain interference and prevent increased use of opioid analgesics by people living with HIV.","['adults newly diagnosed with HIV ( N\u2009=\u2009159', 'people with HIV']",['positive affect skills intervention'],"['pain management', 'pain interference']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.354681,"Results suggest that, even if pain prevalence rises, positive affect skills may reduce pain interference and prevent increased use of opioid analgesics by people living with HIV.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Addington', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Elaine O', 'Initials': 'EO', 'LastName': 'Cheung', 'Affiliation': 'Northwestern University, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Northwestern University, USA.'}]",Journal of health psychology,['10.1177/1359105318769355']
567,31973960,Effects of an Individualized Fasting Program on Fasting Time and Comfort in Infants and Young Children During the Perioperative Period.,"PURPOSE


The study was designed to evaluate the effect of an individualized fasting program on fasting time and comfort in infants and young children during the perioperative period.
DESIGN


A quasiexperimental design was used.
METHODS


The study included 675 children (intervention = 353, control = 322). Data collection tools included Characteristics of Children Form and the Infant Hunger Rating Scale. The fasting program included individualized fasting education and fasting in batches. On the day of the operation, clear liquids were fed 2 hours before surgery and refed after the patient woke after surgery.
FINDINGS


The duration of perioperative fasting and the time to refeeding were shorter, the hunger scores were lower in the intervention group than those in the control group (P < .05). There was no difference in the incidence of vomiting between the two groups (P > .05), and no coughing and bloating occurred.
CONCLUSIONS


The fasting program for infants and young children can shorten the duration of fasting and can reduce the degree of hunger. This program is safe and feasible.",2020,"The duration of perioperative fasting and the time to refeeding were shorter, the hunger scores were lower in the intervention group than those in the control group (P < .05).","['Infants and Young Children', 'infants and young children during the perioperative period', '675 children (intervention\xa0=\xa0353, control\xa0=\xa0322', 'infants and young children']","['individualized fasting program', 'Individualized Fasting Program']","['Infant Hunger Rating Scale', 'incidence of vomiting', 'fasting time and comfort', 'hunger scores', 'duration of perioperative fasting and the time to refeeding', 'coughing and bloating', 'Fasting Time and Comfort']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0222045'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}]",675.0,0.0128534,"The duration of perioperative fasting and the time to refeeding were shorter, the hunger scores were lower in the intervention group than those in the control group (P < .05).","[{'ForeName': 'Canping', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China. Electronic address: 6201005@zju.edu.cn.""}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': ""Department of Respiratory, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}, {'ForeName': 'Shuangping', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ""Department of Day Surgery, The Children's Hospital School of Medicine Zhejiang University, Hangzhou, China.""}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.08.014']
568,20472939,Early CPAP versus surfactant in extremely preterm infants.,"BACKGROUND


There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants.
METHODS


We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen).
RESULTS


A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups.
CONCLUSIONS


The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)",2010,"Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01).","['infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation', 'extremely preterm infants', 'preterm infants', 'A total of 1316 infants were enrolled in the study']","['CPAP versus surfactant', 'CPAP', 'continuous positive airway pressure (CPAP) and early surfactant treatment', 'CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy', 'intubation and surfactant treatment']","['frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia', 'bronchopulmonary dysplasia', 'death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen', 'rates of other adverse neonatal outcomes']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011212', 'cui_str': 'Centers, Hospital Birth'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",1316.0,0.371486,"Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Neil N', 'Initials': 'NN', 'LastName': 'Finer', 'Affiliation': ''}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': ''}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Rich', 'Affiliation': ''}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': ''}, {'ForeName': 'Abbot R', 'Initials': 'AR', 'LastName': 'Laptook', 'Affiliation': ''}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Yoder', 'Affiliation': ''}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Faix', 'Affiliation': ''}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': ''}, {'ForeName': 'W Kenneth', 'Initials': 'WK', 'LastName': 'Poole', 'Affiliation': ''}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Donovan', 'Affiliation': ''}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': ''}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz', 'Affiliation': ''}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Buchter', 'Affiliation': ''}, {'ForeName': 'Pablo J', 'Initials': 'PJ', 'LastName': 'Sánchez', 'Affiliation': ''}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Kennedy', 'Affiliation': ''}, {'ForeName': 'Nirupama', 'Initials': 'N', 'LastName': 'Laroia', 'Affiliation': ''}, {'ForeName': 'Brenda B', 'Initials': 'BB', 'LastName': 'Poindexter', 'Affiliation': ''}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cotten', 'Affiliation': ''}, {'ForeName': 'Krisa P', 'Initials': 'KP', 'LastName': 'Van Meurs', 'Affiliation': ''}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Duara', 'Affiliation': ''}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Narendran', 'Affiliation': ''}, {'ForeName': 'Beena G', 'Initials': 'BG', 'LastName': 'Sood', 'Affiliation': ''}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': ''}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Bell', 'Affiliation': ''}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': ''}, {'ForeName': 'Kristi L', 'Initials': 'KL', 'LastName': 'Watterberg', 'Affiliation': ''}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Higgins', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa0911783']
569,31402293,Severe obesity and vitamin D deficiency treatment options before bariatric surgery: a randomized clinical trial.,"BACKGROUND


Obesity, which has various complications and co-morbidities, is an epidemic issue worldwide. Vitamin D deficiency (VDD) is a well-known metabolic disorder among patients with severe obesity. While they are good candidates for bariatric surgery, this deficiency can affect the outcome of surgery negatively.
OBJECTIVES


The aim of this study was to compare 3 different VDD treatment strategies for use before bariatric surgery and compare serum vitamin D levels after 7 weeks.
SETTINGS


University hospital, Isfahan, Iran.
METHODS


This was a single-blinded, randomized clinical trial on 100 patients who were referred for bariatric surgery from 2016 to 2018. Vitamin D (VitD) level was checked before surgery for the patients included in the study, if their VitD level was <30 ng/mL. We rechecked their serum VitD in the 8 th  week, after 7 weeks of treatment. The participants were randomly allocated into 3 groups: 33 patients were treated with 50,000 units VitD 3  capsules every week for 7 weeks; 33 patients were treated with a single dose of 300,000 units VitD 3  ampoule; and 34 patients were treated with a combination of a half of the injection dose, followed by the oral capsule for 4 weeks.
RESULTS


No case was lost during the follow-up time. No significant differences were found among the 3 groups in terms of their age (P = .654), body mass index (P = .434), sex (P = .799), initial 25(OH) VitD level (P = .273), and history of supplement use (P = .45). Mean serum VitD levels were 15.21, 13.16, and 13.37 ng/mL, respectively, before the surgery and reached 32.91, 24.74, and 29.49 ng/mL after 7 weeks of treatment in oral, injection, and combined groups, respectively. Finally, the 7-week oral treatment option had significantly higher levels of VitD (P value = .034).
CONCLUSION


VDD treatment with 50,000 units VitD 3  capsule every week for 7 weeks before bariatric surgery yields a higher level of VitD. Based on our findings, injectable supplements are not recommended for VDD treatment.",2019,"Finally, the 7-week oral treatment option had significantly higher levels of VitD (P value = .034).
","['patients with severe obesity', 'University hospital, Isfahan, Iran', '100 patients who were referred for bariatric surgery from 2016 to 2018']","['Vitamin D deficiency (VDD', 'vitamin D deficiency treatment options before bariatric surgery']","['Vitamin D (VitD) level', 'initial 25(OH) VitD level', 'body mass index', 'serum vitamin D levels', 'levels of VitD', 'Mean serum VitD levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0743909,"Finally, the 7-week oral treatment option had significantly higher levels of VitD (P value = .034).
","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Sayadi Shahraki', 'Affiliation': 'Laparoscopic Surgery Fellowship, Department of Surgery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yousefvand', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sheikhbahaei', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Shahabi Shahmiri', 'Affiliation': 'Laparoscopic Surgery Fellowship, Department of Surgery, Isfahan Minimal Invasive Surgery and Obesity Research Center, Alzahra University Hospital, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: shshahabi@yahoo.com.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2019.05.033']
570,30383090,Serum Neurofilament Light Chain for Prognosis of Outcome After Cardiac Arrest.,"Importance


Prognostication of neurologic outcome after cardiac arrest is an important but challenging aspect of patient therapy management in critical care units.
Objective


To determine whether serum neurofilament light chain (NFL) levels can be used for prognostication of neurologic outcome after cardiac arrest.
Design, Setting and Participants


Prospective clinical biobank study of data from the randomized Target Temperature Management After Cardiac Arrest trial, an international, multicenter study with 29 participating sites. Patients were included between November 11, 2010, and January 10, 2013. Serum NFL levels were analyzed between August 1 and August 23, 2017, after trial completion. A total of 782 unconscious patients with out-of-hospital cardiac arrest of presumed cardiac origin were eligible.
Exposures


Serum NFL concentrations analyzed at 24, 48, and 72 hours after cardiac arrest with an ultrasensitive immunoassay.
Main Outcomes and Measures


Poor neurologic outcome at 6-month follow-up, defined according to the Cerebral Performance Category Scale as cerebral performance category 3 (severe cerebral disability), 4 (coma), or 5 (brain death).
Results


Of 782 eligible patients, 65 patients (8.3%) were excluded because of issues with aliquoting, missing sampling, missing outcome, or transport problems of samples. Of the 717 patients included (91.7%), 580 were men (80.9%) and median (interquartile range [IQR]) age was 65 (56-73) years. A total of 360 patients (50.2%) had poor neurologic outcome at 6 months. Median (IQR) serum NFL level was significantly increased in the patients with poor outcome vs good outcome at 24 hours (1426 [299-3577] vs 37 [20-70] pg/mL), 48 hours (3240 [623-8271] vs 46 [26-101] pg/mL), and 72 hours (3344 [845-7838] vs 54 [30-122] pg/mL) (P < .001 at all time points), with high overall performance (area under the curve, 0.94-0.95) and high sensitivities at high specificities (eg, 69% sensitivity with 98% specificity at 24 hours). Serum NFL levels had significantly greater performance than the other biochemical serum markers (ie, tau, neuron-specific enolase, and S100). At comparable specificities, serum NFL levels had greater sensitivity for poor outcome compared with routine electroencephalogram, somatosensory-evoked potentials, head computed tomography, and both pupillary and corneal reflexes (ranging from 29.2% to 49.0% greater for serum NFL level).
Conclusions and Relevance


Findings from this study suggest that the serum NFL level is a highly predictive marker of long-term poor neurologic outcome at 24 hours after cardiac arrest and may be a useful complement to currently available neurologic prognostication methods.",2019,"Serum NFL levels had significantly greater performance than the other biochemical serum markers (ie, tau, neuron-specific enolase, and S100).","['65 patients (8.3%) were excluded because of issues with aliquoting, missing sampling, missing outcome, or transport problems of samples', '717 patients included (91.7%), 580 were men (80.9%) and median (interquartile range [IQR]) age was 65 (56-73) years', '782 unconscious patients with out-of-hospital cardiac arrest of presumed cardiac origin were eligible', '29 participating sites', '782 eligible patients', 'Patients were included between November 11, 2010, and January 10, 2013']",['serum neurofilament light chain (NFL) levels'],"['Main Outcomes and Measures\n\n\nPoor neurologic outcome at 6-month follow-up, defined according to the Cerebral Performance Category Scale as cerebral performance category 3 (severe cerebral disability), 4 (coma), or 5 (brain death', 'Serum NFL levels', 'poor neurologic outcome', 'Exposures\n\n\nSerum NFL concentrations', 'Median (IQR) serum NFL level', 'pupillary and corneal reflexes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0425259', 'cui_str': 'Transport problems (finding)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041654', 'cui_str': 'Unconscious'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C1562562', 'cui_str': 'Light chain measurement'}]","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0222045'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0006110', 'cui_str': 'Brain Dead'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0520451', 'cui_str': 'Corneal Reflexes'}]",782.0,0.108903,"Serum NFL levels had significantly greater performance than the other biochemical serum markers (ie, tau, neuron-specific enolase, and S100).","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Moseby-Knappe', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Mattsson', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Helsingborg Hospital, Lund, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Kaj', 'Initials': 'K', 'LastName': 'Blennow', 'Affiliation': 'Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Department of Clinical Sciences Lund, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Dragancea', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Insel', 'Affiliation': 'Clinical Memory Research Unit, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rylander', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Westhall', 'Affiliation': 'Department of Clinical Sciences Lund, Clinical Neurophysiology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergaard', 'Affiliation': 'Departments of Cardiology, Rigshospitalet and Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Matt P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Departments of Cardiology, Rigshospitalet and Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kuiper', 'Affiliation': 'Department of Intensive Care, Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Stammet', 'Affiliation': 'National Rescue Services, Luxembourg City, Luxembourg.'}, {'ForeName': 'Michael C Jaeger', 'Initials': 'MCJ', 'LastName': 'Wanscher', 'Affiliation': 'Department of Cardiothoracic Anaesthesia, The Heart Center, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research Department, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Clinical Sciences Lund, Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Intensive Care, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Pellis', 'Affiliation': 'Anesthesia and Intensive Care, Card. G. Panico Hospital Agency, Tricase, Italy.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Lund University, Skåne University Hospital, Lund, Sweden.'}]",JAMA neurology,['10.1001/jamaneurol.2018.3223']
571,31982493,Systemic Treatment With Glucocorticoids Is Associated With Incident Hypoglycemia and Mortality: A Historical Prospective Analysis.,"PURPOSE


The purpose of this study was to examine whether the increased glycemic variability associated with systemic glucocorticoid treatment is also associated with increased incidence of hypoglycemia.
METHODS


All patients discharged from internal medicine units between 2010 and 2013 were included in this retrospective analysis. Patients were assigned to 3 groups: Group 1: no steroids were prescribed;. Group 2: topical or inhaled steroids were prescribed with no systemic treatment; and Group 3: systemic steroids were prescribed, with or without topical or inhaled treatment.
RESULTS


A total of 45,272 patients were included in the study. Patients in Group 3 had significantly higher rates of hypoglycemia (10.9%) compared to patients in Group 2 (7.4%), and patients in Group 1 (7.3%). Patients with diabetes mellitus had higher rates of hypoglycemia compared to patients without diabetes mellitus (14.3% vs 4.9%) but exhibited similar trends in response to steroid treatment. Multivariate analysis showed that systemic steroids were associated with increased risk for hypoglycemia (odds ratio [OR] 1.513, 95% confidence interval [CI] 1.311-1.746, P <0.001). Hypoglycemia associated with systemic steroid treatment was also associated with increased risk of death (hazard ratio [HR] 2.328, 95% CI 1.931-2.807, P <0.001). Patients who were treated with systemic steroids but did not have hypoglycemia did not have higher mortality rates (HR 1.068, 95% CI 0.972-1.175, P = 0.171).
CONCLUSION


Treatment with systemic steroids is associated with increased hypoglycemia incidence during hospitalization. Patients treated with steroids that had incident hypoglycemia had a higher 1-year mortality risk compared to patients without hypoglycemia treated with steroids.",2020,"Multivariate analysis showed that systemic steroids were associated with increased risk for hypoglycemia (OR 1.513, 95% CI 1.311- 1.746, p<0.001).","['A total of 45,272 patients were included in the study', 'patients discharged from internal medicine units between 2010 and 2013', 'Patients with diabetes mellitus']","['systemic steroids', 'Systemic steroids were prescribed, with or without topical or inhaled treatment', 'Topical or inhaled steroids with no systemic treatment', 'glucocorticoids']","['incident hypoglycemia and mortality', 'hypoglycemia', 'risk of death', 'mortality rates', 'rates of hypoglycemia', 'year mortality risk', 'risk for hypoglycemia', 'Hypoglycemia', 'incident hypoglycemia', 'hypoglycemia incidence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",45272.0,0.111291,"Multivariate analysis showed that systemic steroids were associated with increased risk for hypoglycemia (OR 1.513, 95% CI 1.311- 1.746, p<0.001).","[{'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Khanimov', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Boaz', 'Affiliation': 'Department of Nutrition Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Shimonov', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Surgery ""A"", Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Diabetes Unit, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Leibovitz', 'Affiliation': 'Department of Internal Medicine ""A"", Yoseftal Hospital, Eilat, Israel. Electronic address: eyalle2@clalit.org.il.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.026']
572,31977104,Reaching out to big losers leads to sustained reductions in gambling over 1 year: a randomized controlled trial of brief motivational contact.,"BACKGROUND AND AIMS


A previous randomized controlled trial demonstrated that telephone- and letter-based motivational interventions with high-expenditure gamblers had significant short-term positive effects on gambling and use of responsible gambling tools. This post-trial follow-up examined outcomes in gambling expenditure over 12 months.
DESIGN


Observational study following a three-arm randomized controlled trial.
SETTING


Customers of Norsk Tipping (NT) gambling platforms, Norway.
PARTICIPANTS


A total of 1003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age and net losses. Mean age was 53.4 years; 19% were women, mean yearly loss for 2016 was 88 197 NoK. Interventions and comparator Feedback intervention by telephone, letter or a no-contact control condition.
MEASUREMENTS


Primary outcome measure was gambling theoretical loss, derived from the NT customer database. Secondary outcomes were responsible gambling customer actions and whether or not the participant was retained as an NT customer.
FINDINGS


Per-protocol analyses of triplets who received the telephone call or letter as randomly assigned (n = 596) showed a positive and sustained effect over 12 months: the telephone group showed a 30% reduction in theoretical loss (d = 0.44) and the letter group 13% (d = 0.18), both outperforming the control group with a 7% reduction (d = 0.11). The telephone condition was superior to both the letter and control conditions in per-protocol (P < 0.001) and to control condition in intention-to-treat analyses (ITT) (P < 0.001). Individuals in the telephone condition took more responsible gambling actions. The letter condition had better outcomes than the control in the ITT-only analysis (P < 0.001). More than 93% were still customers a year after the intervention.
CONCLUSIONS


Personal contact with high-expenditure gambling customers in Norway that provided individualized feedback on expenditures was associated with reduced theoretical losses and greater use of responsible gambling tools over a 12-month period, compared with no contact. Telephone intervention with customers had a larger impact than a mailed letter.",2020,The phone condition was superior to both the letter and control conditions in per protocol (p<.001) and to control condition in intention to treat analyses (ITT) (p<.001).,"['Customers of Norsk Tipping (NT) gambling platforms, Norway', 'Mean age 53.4 years, 19% were women, mean yearly loss for 2016 was 88,197 NoK. Interventions and comparator Feedback intervention by telephone, letter, or a no-contact control condition', '1,003 statistical triplets from the top 0.5% of customers based upon annual expenditure, matched on sex, age, and net losses']","['phone and letter-based motivational interventions', 'Telephone intervention', 'motivational contact']","['responsible gambling actions', 'gambling theoretical loss, derived from the Norsk Tipping customer database', 'theoretic loss', 'responsible gambling customer actions and whether the participant was retained as a NT customer']","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}]",,0.231814,The phone condition was superior to both the letter and control conditions in per protocol (p<.001) and to control condition in intention to treat analyses (ITT) (p<.001).,"[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Jonsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgins', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Munck', 'Affiliation': 'Department of Education and Special Education, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14982']
573,31975053,Short-term time-restricted feeding is safe and feasible in non-obese healthy midlife and older adults.,"Chronic calorie restriction (CR) improves cardiovascular function and several other physiological markers of healthspan. However, CR is impractical in non-obese older humans due to potential loss of lean mass and bone density, poor adherence, and risk of malnutrition. Time-restricted feeding (TRF), which limits the daily feeding period without requiring a reduction in calorie intake, may be a promising alternative healthspan-extending strategy for midlife and older adults; however, there is limited evidence for its feasibility and efficacy in humans. We conducted a randomized, controlled pilot study to assess the safety, tolerability, and overall feasibility of short-term TRF (eating <8 h day -1  for 6 weeks) without weight loss in healthy non-obese midlife and older adults, while gaining initial insight into potential efficacy for improving cardiovascular function and other indicators of healthspan. TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake. Cardiovascular function was not enhanced by short-term TRF in this healthy cohort, but functional (endurance) capacity and glucose tolerance were modestly improved. These results provide a foundation for conducting larger clinical studies of TRF in midlife and older adults, including trials with a longer treatment duration.",2020,"TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake.","['non-obese healthy midlife and older adults', 'healthy non-obese midlife and older adults', 'midlife and older adults']","['Chronic calorie restriction (CR', 'TRF', 'short-term TRF (eating <8\xa0h\xa0day -1  for 6\xa0weeks) without weight loss', 'Time-restricted feeding (TRF', 'Short-term time-restricted feeding']","['Cardiovascular function', 'functional (endurance) capacity and glucose tolerance', 'safe and well-tolerated', 'safety, tolerability, and overall feasibility', 'lean mass, bone density, or nutrient intake', 'cardiovascular function']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",,0.0344111,"TRF was safe and well-tolerated, associated with excellent adherence and reduced hunger, and did not influence lean mass, bone density, or nutrient intake.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Martens', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA. cmartens@udel.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Rossman', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Mazzo', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Jankowski', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Erzsebet E', 'Initials': 'EE', 'LastName': 'Nagy', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Blair A', 'Initials': 'BA', 'LastName': 'Denman', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Richey', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Ziemba', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Center for Innovative Design & Analysis, University of Colorado School of Public Health, Aurora, CO, 80045, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, 35294, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Diseases and Hypertension, University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Seals', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, 80309, USA.'}]",GeroScience,['10.1007/s11357-020-00156-6']
574,30946260,Evaluating the Effects of a Novel Neuromuscular Neck Training Device on Multiplanar Static and Dynamic Neck Strength: A Pilot Study.,"Versteegh, TH, Dickey, JP, Emery, CA, Fischer, LK, MacDermid, JC, and Walton, DM. Evaluating the effects of a novel neuromuscular neck training device on multiplanar static and dynamic neck strength: A pilot study. J Strength Cond Res 34(3): 708-716, 2020-The neck serves an important function in damping the transference of acceleration forces between the head and the trunk, such as that occurring during contact sports or motor vehicle collisions. An inability to adequately dissipate forces has been proposed as a potential mechanism for clinical conditions such as whiplash or concussion, but current approaches to neck training may not be targeting the correct mechanisms. The purpose of this study was to explore the training effect of a novel neuromuscular strengthening protocol on dynamic and static neck strength. This was a quasiexperimental pilot study design with intervention (n = 8) and control (n = 10) groups. The intervention group was trained (twice/week, ∼10 minutes, for 7 weeks) on a training device that uses self-generated centripetal force to create a dynamic rotational resistance. This protocol is intended to target the ability of the neck muscles to perform coordinated multiplanar plyometric contractions. Both groups also continued with traditional neck strengthening that included training on a straight-plane, isotonic, 4-way neck machine. Performance on the training device showed improvement after routine practice within 1 week, as evidenced by a trend toward increased peak speed in revolutions per minute (RPM). After 7 weeks, peak RPM increased from 122.8 (95% confidence interval [CI], 91.3-154.4) to 252.3 (95% CI, 241.5-263.1). There was also a large positive effect size (Hedge's d, 0.68) in isometric composite (multiplane) neck strength favoring the intervention group over the control group (difference, 20 N; 95% CI, -8 to 48). The largest magnitude strength improvement in a single plane was in axial rotation and also favored the intervention group over the control group (Hedge's d, 1.24; difference, 46 N; 95% CI, 9-83). Future studies should explore whether the dynamic training presented here could help reduce the risk of sports concussion, whiplash, or other head-neck trauma.",2020,"The largest magnitude strength improvement in a single plane was in axial rotation and also favored the intervention group over the control group (Hedge's d, 1.24; difference, 46 N; 95% CI, 9-83).",[],"['traditional neck strengthening that included training on a straight-plane, isotonic, 4-way neck machine', 'Novel Neuromuscular Neck Training Device', 'J Strength Cond Res XX(X', 'novel neuromuscular neck training device', 'novel neuromuscular strengthening protocol']","['peak RPM', 'dynamic and static neck strength', 'isometric composite (multiplane) neck strength', 'Multiplanar Static and Dynamic Neck Strength', 'multiplanar static and dynamic neck strength', 'Versteegh, TH, Dickey, JP, Emery, CA, Fischer, LK, MacDermid, JC, and Walton, DM', 'peak speed in revolutions per minute (RPM']",[],"[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C1813909', 'cui_str': '4-Way'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0582523', 'cui_str': 'rpm'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",,0.0434391,"The largest magnitude strength improvement in a single plane was in axial rotation and also favored the intervention group over the control group (Hedge's d, 1.24; difference, 46 N; 95% CI, 9-83).","[{'ForeName': 'Theodore H', 'Initials': 'TH', 'LastName': 'Versteegh', 'Affiliation': 'School of Physical Therapy, Western University, Elborn College, London, Ontario, Canada.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dickey', 'Affiliation': 'School of Kinesiology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Emery', 'Affiliation': 'Sport Injury Prevention Research Center, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Fischer', 'Affiliation': 'Faculty of Health Sciences, Western University, London, Ontario, Canada.'}, {'ForeName': 'Joy C', 'Initials': 'JC', 'LastName': 'MacDermid', 'Affiliation': 'School of Physical Therapy, Western University, London, Ontario, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Walton', 'Affiliation': 'School of Physical Therapy, Western University, London, Ontario, Canada.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003091']
575,31973959,Video Glasses Reduce Preoperative Anxiety Compared With Portable Multimedia Player in Children: A Randomized Controlled Trial.,"PURPOSE


Preoperative anxiety in children is challenging for anesthesia providers and nurses. The use of video glasses (VG), an immersive head mount display, helps conceal the unfamiliar operating room environment from the patient's visual field. The aim of this study was to determine the anxiolytic effect of VG compared with that of a portable multimedia player (PMP) during the preoperative period in children.
DESIGN


Prospective randomized trial.
METHODS


Participants were randomized into VG or PMP groups. Patients watched their favorite animation videos using the allocated device from the time of entering the preanesthetic holding area to the end of anesthetic induction. We evaluated modified Yale Preoperative Anxiety Scale scores during anesthetic induction.
FINDINGS


The modified Yale Preoperative Anxiety Scale score in the VG group was significantly lower than that in the PMP group (P = .001).
CONCLUSIONS


In children, the anxiolytic effect of VG during the preoperative period is larger than that of PMP.",2020,"The modified Yale Preoperative Anxiety Scale score in the VG group was significantly lower than that in the PMP group (P = .001).
","['children', 'Participants were randomized into VG or PMP groups', 'Children']","['PMP', 'Portable Multimedia Player', 'portable multimedia player (PMP', 'video glasses (VG']","['Preoperative Anxiety', 'modified Yale Preoperative Anxiety Scale scores', 'anxiolytic effect of VG', 'modified Yale Preoperative Anxiety Scale score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0017596', 'cui_str': 'Glass'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}]",,0.0478107,"The modified Yale Preoperative Anxiety Scale score in the VG group was significantly lower than that in the PMP group (P = .001).
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chaki', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan. Electronic address: chakitomohiro0728@yahoo.co.jp.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Hirata', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.10.001']
576,28056897,A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study): design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease.,"BACKGROUND


Recognizing patterns of coronary heart disease (CHD) risk in families helps to identify and target individuals who may have the most to gain from preventive interventions. The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in high risk families. The proposed care model targets the structural and environmental conditions that predispose high risk families to development of CHD through the following interventions: 1) screening for cardiovascular risk factors, 2) providing lifestyle interventions 3) providing a framework for linkage to appropriate primary health care facility, and 4) active follow-up of intervention adherence.
METHODS


Initially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package and feedback on the intervention. Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic (cost-effectiveness analyses) and qualitative evaluation (process outcomes) to estimate value and acceptability. Scalability is informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.
DISCUSSION


Knowledge generated from this trial has the potential to significantly affect new programmatic policy and clinical guidelines that will lead to improvements in cardiovascular health in India.
TRIAL REGISTRATION NUMBER


NCT02771873, registered in May 2016 ( https://clinicaltrials.gov/ct2/show/results/NCT02771873 ).",2017,Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families.,"['high risk families', '740 families comprising 1480 participants', 'individuals with family history of premature coronary heart disease']","['Lifestyle Intervention', 'package of interventions (integrated care model']",[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],740.0,0.069258,Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families.,"[{'ForeName': 'Panniyammakal', 'Initials': 'P', 'LastName': 'Jeemon', 'Affiliation': 'Public Health Foundation of India, New Delhi, India. jeemon.p@phfi.org.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Harikrishnan', 'Affiliation': 'Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sanjay', 'Affiliation': 'Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India.'}, {'ForeName': 'Sivasankaran', 'Initials': 'S', 'LastName': 'Sivasubramonian', 'Affiliation': 'Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Lekha', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Sandosh', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, New Delhi, India.'}]",BMC public health,['10.1186/s12889-016-3928-6']
577,31659983,The obesity paradox revisited: body mass index and -long-term outcomes after PCI from a large pooled patient-level database.,"AIMS


The aim of this study was to evaluate the relationship between body mass index (BMI) and outcomes in patients with coronary artery disease undergoing percutaneous revascularisation.
METHODS AND RESULTS


In 13 randomised trials, 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5 ≤BMI <25, used as reference), overweight (25 ≤BMI <30), and obese (Class I [30 ≤BMI <35], Class II [35 ≤BMI <40], or Class III [BMI ≥40]). The primary endpoint was all-cause death at five years. Secondary endpoints were cardiac and non-cardiac death, target (TLR) and non-target lesion revascularisation (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis. Despite adjustment for multiple confounders, overweight and Class I obesity were associated with lower all-cause mortality versus normal weight (HR 0.83, 95% CI: 0.71-0.96, and HR 0.83, 95% CI: 0.69-0.96, respectively); however, non-cardiac death was the major contributor to this effect (HR 0.77, 95% CI: 0.63-0.94 for overweight). Conversely, cardiac mortality was higher in severely obese individuals (HR 1.62, 95% CI: 1.05-2.51 for Class III obesity). Obesity was associated with higher rates of NTLR (HR 1.28, 95% CI: 1.04-1.58 for Class II obesity) but not with TLR, MI and stent thrombosis.
CONCLUSIONS


Moderately increased BMI is associated with improved survival post PCI, mostly due to lower non-cardiac but not cardiac mortality.",2020,"Moderately increased BMI is associated with improved survival post-PCI, mostly due to lower non-cardiac but not cardiac mortality.","['patients with coronary artery disease undergoing percutaneous revascularization', '13 randomized trials 22,922 patients were stratified (in kg/m2) as underweight (BMI &lt;18.5), normal weight (18.5≤BMI&lt;25, used as reference), overweight (25≤BMI&lt;30), and obese (Class I [30≤BMI&lt;35], Class II [35≤BMI&lt;40], or Class III [BMI≥40']",[],"['BMI', 'rates of NTLR', 'cardiac mortality', 'cause death', 'cardiac and non-cardiac death, target (TLR) and non-target lesion revascularization (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.0990975,"Moderately increased BMI is associated with improved survival post-PCI, mostly due to lower non-cardiac but not cardiac mortality.","[{'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Wolny', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': ''}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': ''}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': ''}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': ''}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': ''}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ''}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00467']
578,30198967,RANIBIZUMAB IN PIGMENT EPITHELIAL TEARS SECONDARY TO AGE-RELATED MACULAR DEGENERATION: A Prospective Study.,"PURPOSE


To assess efficacy of intravitreal ranibizumab in retinal pigment epithelium tears secondary to neovascular age-related macular degeneration.
METHODS


The Ranibizumab In Pigment epithelial tears secondary to age-related macular degeneration (RIP) study is a prospective, single-arm, multicenter, investigator-initiated trial. Twenty four eyes of 24 patients with a retinal pigment epithelium tear secondary to age-related macular degeneration received monthly intravitreal injection of 0.5mg ranibizumab for 12 months, together with monthly assessments of morphologic and functional efficacy parameters. Primary outcome measure was mean best-corrected visual acuity at final visit compared with baseline.
RESULTS


Mean best-corrected visual acuity remained stable over the 12-month study period with 50.3 Early Treatment of Diabetic Retinopathy Study letters (±18.7; Snellen equivalent 20/100) at baseline and 52.9 letters (±19.7; Snellen equivalent 20/100) at final visit (P = 0.39). One eye (4%) experienced a vision loss of ≥15 letters, and 2 eyes (8%) gained ≥15 letters. Mean central retinal thickness decreased from 571 µm (±185 µm) to 436 µm (±171 µm; P = 0.0001). Vision-related quality of life was stable with a mean VFQ-25 score of 79.0 (±10.8) at baseline and 74.3 (±13.9) at final visit (P = 0.12).
CONCLUSION


In retinal pigment epithelium tears secondary to age-related macular degeneration, monthly intravitreal ranibizumab therapy results in stabilization of visual acuity over 12 months.",2019,"Vision-related quality of life was stable with a mean VFQ-25 score of 79.0 (±10.8) at baseline and 74.3 (±13.9) at final visit (P = 0.12).
","['Twenty four eyes of 24 patients with a retinal pigment epithelium tear secondary to age-related macular degeneration received monthly', 'Pigment epithelial tears secondary to age-related macular degeneration', 'retinal pigment epithelium tears secondary to neovascular age-related macular degeneration']","['intravitreal injection of 0.5mg ranibizumab', 'intravitreal ranibizumab', 'Ranibizumab', 'TEARS']","['Mean best-corrected visual acuity', 'visual acuity', 'Mean central retinal thickness', 'Vision-related quality of life', 'mean VFQ-25 score', 'mean best-corrected visual acuity', 'vision loss']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035322', 'cui_str': 'Retinal Pigment Epithelium'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0333610', 'cui_str': 'Pigmented (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",24.0,0.118113,"Vision-related quality of life was stable with a mean VFQ-25 score of 79.0 (±10.8) at baseline and 74.3 (±13.9) at final visit (P = 0.12).
","[{'ForeName': 'Petra P', 'Initials': 'PP', 'LastName': 'Larsen', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Oishi', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Mohammad Seleman', 'Initials': 'MS', 'LastName': 'Bedar', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Philipp K R', 'Initials': 'PKR', 'LastName': 'Heymer', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Christoph R', 'Initials': 'CR', 'LastName': 'Clemens', 'Affiliation': 'Department of Ophthalmology, University of Münster, Münster, Germany.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'König', 'Affiliation': 'Department of Ophthalmology, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gutfleisch', 'Affiliation': 'Department of Ophthalmology, St. Franziskus Hospital, Münster, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pauleikhoff', 'Affiliation': 'Department of Ophthalmology, St. Franziskus Hospital, Münster, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Eter', 'Affiliation': 'Department of Ophthalmology, University of Münster, Münster, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Department of Ophthalmology, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Tim U', 'Initials': 'TU', 'LastName': 'Krohne', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002311']
579,30204729,"FACEDOWN POSITIONING AFTER VITRECTOMY WILL NOT FACILITATE MACULAR HOLE CLOSURE BASED ON SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY IMAGING IN GAS-FILLED EYES: A Prospective, Randomized Comparative Interventional Study.","PURPOSE


To compare clinical outcomes in eyes with macular hole (MH) managed by either facedown (FD) or no-FD (nFD) postoperative positioning protocols.
METHODS


This is a prospective randomized cohort study. Eighty eyes of 80 consecutive patients with MH who had undergone vitrectomy surgery with internal limiting membrane peeling and gas tamponade were included in this study. Forty eyes of 40 patients who were kept in FD position for 3 days after surgery were assigned to the FD group, 40 eyes of 40 patients with nFD positioning were assigned to the nFD group. Macular hole was examined with swept-source optical coherence tomography images at 1 day, 2 days, 3 days, 2 weeks, 1 month, and 3 months after surgery. The MH closure rate and change of best-corrected visual acuity were compared.
RESULTS


At postoperative Day 1, MH was closed in 24 of 32 eyes (with clear optical coherence tomography images) (75%) in the FD group and 23 of 30 eyes (with clear optical coherence tomography images) (77%) in the nFD group (P = 0.97). At postoperative Day 2, MH closure was confirmed in 32 of 36 eyes (88.9%) in the FD group and in 31 of 33 eyes (94%) in the nFD group (P = 0.84), and the results were unchanged at Day 3. At 2 weeks after surgery, clear optical coherence tomography images were acquired from all eyes in both groups, and MH closure was confirmed in 36 of 40 eyes (90%) in the FD group and in 37 of 40 (92.5%) eyes in the nFD group (P = 0.91). Macular hole closure was not achieved in eyes that were kept open by Day 3 after surgery, and none of the eyes with confirmed MH closure by Day 3 had a reopening of the MH by 3 months. The distribution of macular configuration at 3 months was not significantly different between the two groups (P = 0.96). There was no difference in terms of the improvement in best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letters gain) between the 2 groups at 1 month (P = 0.22) and 3 months (P = 0.45).
CONCLUSION


The nFD protocol neither delayed the MH closure nor decreased the final closure rate after vitrectomy surgery. Therefore, postoperative prone position seems to be unnecessary for all MH repair procedures.",2019,The distribution of macular configuration at 3 months was not significantly different between the two groups (P = 0.96).,"['Eighty eyes of 80 consecutive patients with MH who had undergone vitrectomy surgery with internal limiting membrane peeling and gas tamponade', 'eyes with macular hole (MH) managed by either', 'Forty eyes of 40 patients who were kept in FD position for 3 days after surgery were assigned to the FD group, 40 eyes of 40 patients with nFD positioning']","['facedown (FD) or no-FD (nFD) postoperative positioning protocols', 'MACULAR HOLE CLOSURE']","['MH closure rate and change of best-corrected visual acuity', 'Macular hole closure', 'MH closure', 'final closure rate', 'distribution of macular configuration', 'best-corrected visual acuity']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3544111', 'cui_str': 'Internal limiting membrane peeling'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0579016', 'cui_str': 'Tamponade - action (qualifier value)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0618845', 'cui_str': 'NFD'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",40.0,0.0422695,The distribution of macular configuration at 3 months was not significantly different between the two groups (P = 0.96).,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Hong', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Department of Ophthalmology, Wuhan General Hospital of PLA (Clinical Medicine Center of Eye Fundus Laser in Hubei Provience), Wuhan, Hubei, China.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002325']
580,31969796,Randomized Clinical Trial of Surgical vs. Percutaneous vs. Hybrid Revascularization in Multivessel Coronary Artery Disease: Residual Myocardial Ischemia and Clinical Outcomes at One Year-Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS).,"Aim


Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved. We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI.
Methods


Consecutive MV-CAD patients ( n  = 155) were randomized (1 : 1 : 1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy. SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control.
Results


Data are given, respectively, for the CABG, HCR, and MV-PCI arms. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% ( p =0.71). Hospital stay was 13.8 vs. 13.5 vs. 4.5 days ( p  < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks ( p  < 0.001). At 12 months, RI was 5 (2, 9)% vs. 5 (3, 7)% vs. 6 (3, 10)% (median; Q1, Q3) with noninferiority  p  values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs. 8.2% vs. 5.9% ( p =0.05). Clinical target vessel/graft failure occurred in 12.0% vs. 11.5% vs. 11.3% ( p =0.62). Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs. 13.4% vs. 13.2%;  p =0.83).
Conclusion


In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months. There was no midterm indication of any added value of HCR. Hospital stay and sick-leave duration were shortest with MV-PCI. While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization. This trial is registered with NCT01699048.",2020,"Hospital stay was 13.8 vs. 13.5 vs. 4.5 days ( p  < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks ( p  < 0.001).","['Methods\n\n\nConsecutive MV-CAD patients ( n \u2009=\u2009155', 'Multivessel Coronary Artery Disease', 'multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery']","['Hybrid coronary REvascularization Versus Stenting or Surgery (HREVS', 'conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents', 'Surgical vs. Percutaneous vs. Hybrid Revascularization', 'MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR']","['Clinical target vessel/graft failure', 'Incomplete revascularization rate', 'CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE', 'Major adverse cardiac and cerebral event (MACCE) rate', 'Rates of angiographic graft stenosis/occlusion or in-segment restenosis', 'sick-leave duration', 'Hospital stay and sick-leave duration', 'Hospital stay']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",155.0,0.122152,"Hospital stay was 13.8 vs. 13.5 vs. 4.5 days ( p  < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks ( p  < 0.001).","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Ganyukov', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Kochergin', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Shilov', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Tarasov', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Skupien', 'Affiliation': 'Jagiellonian University School of Medicine, Krakow, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szot', 'Affiliation': 'Jagiellonian University School of Medicine, Krakow, Poland.'}, {'ForeName': 'Aleksandr', 'Initials': 'A', 'LastName': 'Kokov', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Popov', 'Affiliation': 'Federal State Budgetary Institution A. V. Vishnevsky Institute of Surgery, Moscow, Russia.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Kozyrin', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Barbarash', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Barbarash', 'Affiliation': 'Federal State Budgetary Institution ""Research Institute for Complex Issues of Cardiovascular Diseases"", Kemerovo, Russia.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Musialek', 'Affiliation': 'Jagiellonian University School of Medicine, Krakow, Poland.'}]",Journal of interventional cardiology,['10.1155/2020/5458064']
581,31203062,Mixed Reality-Based Preoperative Planning for Training of Percutaneous Transforaminal Endoscopic Discectomy: A Feasibility Study.,"OBJECTIVE


To explore the effect of preoperative planning using mixed reality (MR) on training of percutaneous transforaminal endoscopic discectomy (PTED).
METHODS


Before the training, we invited an experienced chief physician to plan the puncture path of PTED on the X-ray films of the lumbar spine model and the 3D Slicer platform, respectively, and used this as the standard to guide trainees. In the aggregate, 60 young residents were randomly divided into Group A (N = 30) and Group B (N = 30). Group A learned the 2-dimensional standard planning route, whereas Group B learned the standard route planning based on MR through the 3D Slicer platform. Then, trainees were asked to conduct PTED puncture on a lumbar spine model. Questionnaires were distributed to trainees before and after the training. During the training, puncture times, operating time (minutes), and fluoroscopy times were recorded.
RESULTS


After the training, it was obvious that more trainees showed their recognition of MR, believing that MR could help preoperative planning and training of PTED. Their high satisfaction with the training indicated the success of our training. Moreover, puncture times, operating time (minutes), and fluoroscopy times of Group B were significantly lower than those of Group A.
CONCLUSIONS


MR technology contributes to preoperative planning of PTED and is beneficial in the training of PTED. It significantly reduces puncture times and fluoroscopy times, providing a standardized method for the training of PTED.",2019,"Moreover, puncture times, operating time (mins) and fluoroscopy times of Group B were significantly lower than those of Group A.
CONCLUSIONS


MR technology contributes to preoperative planning of PTED and is benefit to the training of PTED, which significantly reduces puncture times and fluoroscopy times, providing a standardized method for the training of PTED.",['60 young residents'],"['Mixed Reality Based Preoperative Planning', 'preoperative planning using mixed reality (MR']","['puncture times, operating time (mins) and fluoroscopy times', 'puncture times and fluoroscopy times']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",60.0,0.0145614,"Moreover, puncture times, operating time (mins) and fluoroscopy times of Group B were significantly lower than those of Group A.
CONCLUSIONS


MR technology contributes to preoperative planning of PTED and is benefit to the training of PTED, which significantly reduces puncture times and fluoroscopy times, providing a standardized method for the training of PTED.","[{'ForeName': 'Haiyang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Orthopedic Department, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Orthopedic Department, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': ""Orthopedic Department, Shanghai Tenth People's Hospital, Shanghai, China.""}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Spinal Pain Research Institute, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': ""Orthopedic Department, Shanghai Tenth People's Hospital, Shanghai, China; Spinal Pain Research Institute, Tongji University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shisheng', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Orthopedic Department, Shanghai Tenth People's Hospital, Shanghai, China; Spinal Pain Research Institute, Tongji University School of Medicine, Shanghai, China. Electronic address: tjhss7418@tongji.edu.cn.""}]",World neurosurgery,['10.1016/j.wneu.2019.06.020']
582,31291710,Immunogenicity and Optimal Timing of 13-Valent Pneumococcal Conjugate Vaccination during Adjuvant Chemotherapy in Gastric and Colorectal Cancer: A Randomized Controlled Trial.,"PURPOSE


Pneumococcal vaccination (13-valent pneumococcal conjugate vaccine [PCV13]) is recommended to cancer patients undergoing systemic chemotherapy. However, the optimal time interval between vaccine administration and initiation of chemotherapy has been little studied in adult patients with solid malignancies.
Materials and Methods


We conducted a prospective randomized controlled trial to evaluate whether administering PCV13 on the first day of chemotherapy is non-inferior to vaccinating 2 weeks prior to chemotherapy initiation. Patients were randomly assigned to two study arms, and serum samples were collected at baseline and 4 weeks after vaccination to analyze the serologic response against Streptococcus pneumoniae using a multiplexed opsonophagocytic killing assay.
RESULTS


Of the 92 patients who underwent randomization, 43 patients in arm A (vaccination 2 weeks before chemotherapy) and 44 patients in arm B (vaccination on the first day of chemotherapy) were analyzed. Immunogenicity was assessed by geometric mean and fold-increase of post-vaccination titers, seroprotection rates (percentage of patients with post-vaccination titers > 1:64), and seroconversion rates (percentage of patients with > 4-fold increase in post-vaccination titers). Serologic responses to PCV13 did not differ significantly between the two study arms according to all three types of assessments.
CONCLUSION


The overall antibody response to PCV13 is adequate in patients with gastric and colorectal cancer during adjuvant chemotherapy, and no significant difference was found when patients were vaccinated two weeks before or on the day of chemotherapy initiation.",2020,"Serologic responses to PCV13 did not differ significantly between the two study arms according to all three types of assessments.
","['cancer patients undergoing systemic chemotherapy', 'patients with gastric and colorectal cancer', 'adult patients with solid malignancies', 'Gastric and Colorectal Cancer']","['13-Valent Pneumococcal Conjugate Vaccination', 'Pneumococcal vaccination (13-valent pneumococcal conjugate vaccine [PCV13', 'Adjuvant Chemotherapy', 'PCV13']","['overall antibody response', 'seroconversion rates', 'Serologic responses to PCV13', 'geometric mean and fold-increase of post-vaccination titers, seroprotection rates', 'Immunogenicity']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}]","[{'cui': 'C3661918', 'cui_str': 'Pneumococcal conjugate vaccination'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",43.0,0.16419,"Serologic responses to PCV13 did not differ significantly between the two study arms according to all three types of assessments.
","[{'ForeName': 'Wonyoung', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.'}, {'ForeName': 'Jong Gwang', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Hematology/Oncology, School of Medicine, Kyungpook National University, Daegu, Korea.'}, {'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Beom', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei University of College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jun-Eul', 'Initials': 'JE', 'LastName': 'Hwang', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.'}, {'ForeName': 'Hyun-Jung', 'Initials': 'HJ', 'LastName': 'Shim', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.'}, {'ForeName': 'Sang-Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.'}, {'ForeName': 'Min-Ho', 'Initials': 'MH', 'LastName': 'Shin', 'Affiliation': 'Department of Preventive Medicine, Chonnam National University Medical School, Hwasun, Korea.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Ik-Joo', 'Initials': 'IJ', 'LastName': 'Chung', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.'}, {'ForeName': 'Joon Young', 'Initials': 'JY', 'LastName': 'Song', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woo Kyun', 'Initials': 'WK', 'LastName': 'Bae', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.'}]",Cancer research and treatment : official journal of Korean Cancer Association,['10.4143/crt.2019.189']
583,31955940,Ultralong Versus Standard Long Peripheral Intravenous Catheters: A Randomized Controlled Trial of Ultrasonographically Guided Catheter Survival.,"STUDY OBJECTIVE


Ultrasonographically guided intravenous peripheral catheters have dismal dwell time, with most intravenous lines failing before completion of therapy. Catheter length in the vein is directly related to catheter longevity. We investigate the survival of an ultralong ultrasonographically guided intravenous peripheral catheter compared with a standard long one.
METHODS


We conducted a single-site, nonblinded, randomized trial of catheter survival. Adult patients presenting to the emergency department with difficult vascular access were recruited and randomized to receive either standard long, 4.78-cm, 20-gauge ultrasonographically guided intravenous peripheral catheters or ultralong, 6.35-cm, 20-gauge ultrasonographically guided intravenous peripheral catheters. The primary outcome was duration of catheter survival. The secondary outcome was the optimal length of the catheter in the vein to maximize survival. Additional intravenous-related endpoints included first-stick success, time to insertion, number of attempts, thrombosis, and infection.
RESULTS


Between October 2018 and March 2019, 257 patients were randomized, with 126 in the standard long ultrasonographically guided intravenous peripheral catheter group and 131 in the ultralong group. Kaplan-Meier estimate of catheter median survival time in the ultralong group was 136 hours (95% confidence interval [CI] 116 to 311 hours) compared with 92 hours (95% CI 71 to 120 hours) in the standard long group, for a difference of 44 hours (95% CI 2 to 218 hours). The optimal catheter length in the vein was 2.75 cm, and intravenous lines with greater than 2.75 cm inserted had a median survival of 129 hours (95% CI 102 to 202 hours) compared with 75 hours (95% CI 52 to 116 hours) for intravenous lines with less than or equal to 2.75 cm, for a difference of 54 hours (95% CI 10 to 134 hours). Insertion characteristics were similar between the groups: 74.1% versus 79.4% first-stick success (95% CI for the difference -2% to 5%), 1.4 versus 1.3 for number of attempts (95% CI for the difference -0.1 to 0.3), and 6.9 versus 5.9 minutes to completion (95% CI for the difference -1.3 to 3.4) with ultralong versus standard long, respectively. There were no cases of infection or thrombosis.
CONCLUSION


This study demonstrated increased catheter survival when the ultralong compared with the standard long ultrasonographically guided intravenous peripheral catheter was used, whereas insertion characteristics and safety appeared similar.",2020,"This study demonstrated increased catheter survival when the ultralong compared with the standard long ultrasonographically guided intravenous peripheral catheter was used, whereas insertion characteristics and safety appeared similar.","['Adult patients presenting to the emergency department with difficult vascular access', '257 patients were randomized, with 126 in the', 'Between October 2018 and March 2019']","['Ultrasonographically Guided Catheter Survival', '20-gauge ultrasonographically guided intravenous peripheral catheters or ultralong, 6.35-cm, 20-gauge ultrasonographically guided intravenous peripheral catheters', 'Ultralong Versus Standard Long Peripheral Intravenous Catheters', 'standard long ultrasonographically guided intravenous peripheral catheter']","['optimal catheter length', 'Catheter length', 'stick success, time to insertion, number of attempts, thrombosis, and infection', 'optimal length of the catheter in the vein to maximize survival', 'median survival', 'infection or thrombosis', 'catheter median survival time', 'duration of catheter survival', 'Insertion characteristics', 'catheter survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C0221799', 'cui_str': 'Guiding catheter, device (physical object)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1827740', 'cui_str': 'Peripheral catheter (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4318418', 'cui_str': 'Stick'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",257.0,0.261121,"This study demonstrated increased catheter survival when the ultralong compared with the standard long ultrasonographically guided intravenous peripheral catheter was used, whereas insertion characteristics and safety appeared similar.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI. Electronic address: amit.bahl@beaumont.edu.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Hijazi', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Nai-Wei', 'Initials': 'NW', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lachapelle-Clavette', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Price', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2019.11.013']
584,31950977,Effect of Stress Ulcer Prophylaxis With Proton Pump Inhibitors vs Histamine-2 Receptor Blockers on In-Hospital Mortality Among ICU Patients Receiving Invasive Mechanical Ventilation: The PEPTIC Randomized Clinical Trial.,"Importance


Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs) are often prescribed for patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU). The comparative effect of these drugs on mortality is unknown.
Objective


To compare in-hospital mortality rates using PPIs vs H2RBs for stress ulcer prophylaxis.
Design, Setting, and Participants


Cluster crossover randomized clinical trial conducted at 50 ICUs in 5 countries between August 2016 and January 2019. Patients requiring invasive mechanical ventilation within 24 hours of ICU admission were followed up for 90 days at the hospital.
Interventions


Two stress ulcer prophylaxis strategies were compared (preferential use with PPIs vs preferential use with H2RBs). Each ICU used each strategy sequentially for 6 months in random order; 25 ICUs were randomized to the sequence with use of PPIs and then use of H2RBs and 25 ICUs were randomized to the sequence with use of H2RBs and then use of PPIs (13 436 patients randomized by site to PPIs and 13 392 randomized by site to H2RBs).
Main Outcomes and Measures


The primary outcome was all-cause mortality within 90 days during index hospitalization. Secondary outcomes were clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay.
Results


Among 26 982 patients who were randomized, 154 opted out, and 26 828 were analyzed (mean [SD] age, 58 [17.0] years; 9691 [36.1%] were women). There were 26 771 patients (99.2%) included in the mortality analysis; 2459 of 13 415 patients (18.3%) in the PPI group died at the hospital by day 90 and 2333 of 13 356 patients (17.5%) in the H2RB group died at the hospital by day 90 (risk ratio, 1.05 [95% CI, 1.00 to 1.10]; absolute risk difference, 0.93 percentage points [95% CI, -0.01 to 1.88] percentage points; P = .054). An estimated 4.1% of patients randomized by ICU site to PPIs actually received H2RBs and an estimated 20.1% of patients randomized by ICU site to H2RBs actually received PPIs. Clinically important upper gastrointestinal bleeding occurred in 1.3% of the PPI group and 1.8% of the H2RB group (risk ratio, 0.73 [95% CI, 0.57 to 0.92]; absolute risk difference, -0.51 percentage points [95% CI, -0.90 to -0.12 percentage points]; P = .009). Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group. One adverse event (an allergic reaction) was reported in 1 patient in the PPI group.
Conclusions and Relevance


Among ICU patients requiring mechanical ventilation, a strategy of stress ulcer prophylaxis with use of proton pump inhibitors vs histamine-2 receptor blockers resulted in hospital mortality rates of 18.3% vs 17.5%, respectively, a difference that did not reach the significance threshold. However, study interpretation may be limited by crossover in the use of the assigned medication.
Trial Registration


anzctr.org.au Identifier: ACTRN12616000481471.",2020,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"['50 ICUs in 5 countries between August 2016 and January 2019', 'ICU patients requiring mechanical ventilation', 'Patients Receiving Invasive Mechanical Ventilation', 'Patients requiring invasive mechanical ventilation within 24 hours of ICU admission', 'patients as stress ulcer prophylaxis drugs in the intensive care unit (ICU', '17.0] years; 9691 [36.1%] were women', '26\u202f982 patients who were randomized, 154 opted out, and 26\u202f828 were analyzed (mean [SD] age, 58']","['ICU', 'Proton pump inhibitors (PPIs) or histamine-2 receptor blockers (H2RBs', 'PPIs vs H2RBs', 'Proton Pump Inhibitors vs Histamine-2 Receptor Blockers', 'anzctr.org.au Identifier']","['hospital mortality rates', 'cause mortality', 'Hospital Mortality', 'Clinically important upper gastrointestinal bleeding', 'clinically important upper gastrointestinal bleeding, Clostridioides difficile infection, and ICU and hospital lengths of stay', 'Rates of Clostridioides difficile infection and ICU and hospital lengths of stay']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C2741638', 'cui_str': 'Stress ulcer (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]","[{'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal hemorrhage (disorder)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.126156,Rates of Clostridioides difficile infection and ICU and hospital lengths of stay were not significantly different by treatment group.,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Forbes', 'Affiliation': 'Biostatistics Unit, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Wright', 'Affiliation': 'Intensive Care Unit, Freeman Hospital, Newcastle upon Tyne, England.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Brickell', 'Affiliation': ""University College Dublin-Clinical Research Centre, St Vincent's Hospital, Dublin, Ireland.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Intensive Care Unit, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gattas', 'Affiliation': 'Intensive Care Unit, Royal Prince Alfred Hospital, Camperdown, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Intensive Care Unit, Canberra Hospital, Canberra, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Leanlove', 'Initials': 'L', 'LastName': 'Navarra', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Opgenorth', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta Hospital, Edmonton, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pilcher', 'Affiliation': 'Intensive Care Unit, Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Saxena', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Steve A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, England.'}]",JAMA,['10.1001/jama.2019.22190']
585,31965526,Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial.,"BACKGROUND


Intensive lifestyle interventions (LI) improve outcomes in obesity and type 2 diabetes but are not currently available in usual care.
OBJECTIVE


To compare the effectiveness and costs of two group LI programs, in-person LI and telephone conference call (telephone LI), to medical nutrition therapy (MNT) on weight loss in primary care patients with type 2 diabetes.
DESIGN


A randomized, assessor-blinded, practice-based clinical trial in three community health centers and one hospital-based practice affiliated with a single health system.
PARTICIPANTS


A total of 208 primary care patients with type 2 diabetes, HbA1c 6.5 to < 11.5, and BMI > 25 kg/m 2  (> 23 kg/m 2  in Asians).
INTERVENTIONS


Dietitian-delivered in-person or telephone group LI programs with medication management or MNT referral.
MAIN MEASURES


Primary outcome: mean percent weight change.
SECONDARY OUTCOMES


5% and 10% weight loss, change in HbA1c, and cost per kilogram lost.
KEY RESULTS


Participants' mean age was 62 (SD 10) years, 45% were male, and 77% were White, with BMI 35 (SD 5) kg/m 2  and HbA1c 7.7 (SD 1.2). Seventy were assigned to in-person LI, 72 to telephone LI, and 69 to MNT. The mean percent weight loss (95% CI) at 6 and 12 months was 5.6% (4.4-6.8%) and 4.6% (3.1-6.1%) for in-person LI, 4.6% (3.3-6.0%) and 4.8% (3.3-6.2%) for telephone LI, and 1.1% (0.2-2.0%) and 2.0% (0.9-3.0%) for MNT, with statistically significant differences between each LI arm and MNT (P < 0.001) but not between LI arms (P = 0.63). HbA1c improved in all participants. Compared with MNT, the incremental cost per kilogram lost was $789 for in-person LI and $1223 for telephone LI.
CONCLUSIONS


In-person LI or telephone group LI can achieve good weight loss outcomes in primary care type 2 diabetes patients at a reasonable cost.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02320253.",2020,HbA1c improved in all participants.,"['Type 2 Diabetes in Primary Care', ""Participants' mean age was 62 (SD 10) years, 45% were male, and 77% were White, with BMI 35"", 'three community health centers and one hospital-based practice affiliated with a single health system', 'primary care patients with type 2 diabetes', 'A total of 208 primary care patients with type 2 diabetes, HbA1c 6.5 to <\u200911.5, and BMI >\u200925\xa0kg/m 2  (>\u200923\xa0kg/m 2  in Asians', 'primary care type 2 diabetes patients']","['person LI and telephone conference call (telephone LI', 'medical nutrition therapy (MNT', 'Lifestyle Intervention', 'Dietitian-delivered in-person or telephone group LI programs with medication management or MNT referral', 'Intensive lifestyle interventions (LI', 'MNT']","['mean percent weight loss', 'good weight loss outcomes', 'weight loss, change in HbA1c, and cost per kilogram lost', 'weight loss', 'mean percent weight change']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C1257928', 'cui_str': 'Medical Nutrition Therapy'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",3.0,0.240265,HbA1c improved in all participants.,"[{'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA. delahanty.linda@mgh.harvard.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Levy', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bianca C', 'Initials': 'BC', 'LastName': 'Porneala', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Goldman', 'Affiliation': 'Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'McCarthy', 'Affiliation': 'Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Bissett', 'Affiliation': 'Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA.'}, {'ForeName': 'Anthony Romeo', 'Initials': 'AR', 'LastName': 'Rodriguez', 'Affiliation': 'Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Chase', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'LaRocca', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wheeler', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Wexler', 'Affiliation': 'Diabetes Unit, Department of Medicine, Massachusetts General Hospital (MGH) Diabetes Research Center, Boston, MA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05629-9']
586,31968059,Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial.,"Importance


Approximately 140 million children worldwide have experienced the death of one or both parents. These children, mostly in low- and middle-income countries, have higher rates of mental health problems than those who have not experienced parental death. Cognitive behavioral therapy (CBT) may improve the well-being of these children, but to our knowledge there have been no randomized clinical trials specifically focused on this population.
Objectives


To test the effectiveness of trauma-focused CBT (TF-CBT) for improving posttraumatic stress (PTS) in children in Kenya and Tanzania who have experienced parental death, to test the effects of TF-CBT on other mental health symptoms, and to examine the feasibility of task-shifting with greater reliance on experienced, local lay counselors as trainers and supervisors.
Design, Setting, and Participants


A randomized clinical trial conducted in urban and rural areas of Tanzania and Kenya compared TF-CBT and usual care (UC) for 640 children aged 7 to 13 years who were recruited from February 13, 2013, to July 24, 2015. All children had experienced the death of one or both parents and had elevated PTS and/or prolonged grief. Interviewers were masked to study condition. Participants were followed up for 12 months after the randomized clinical trial. Statistical analysis was performed from February 3, 2017, to August 26, 2019. All analyses were on an intent-to-treat basis.
Interventions


In the intervention condition, 320 children received 12 weeks of group TF-CBT delivered by lay counselors who were supervised weekly. In the UC condition, 320 children received community services typically offered to this population.
Main Outcomes and Measures


The primary outcome was PTS, evaluated using a continuous, standardized measure. Other mental health symptoms and child-guardian relationship were also measured.
Results


A total of 640 children (320 girls and 320 boys; mean [SD] age, 10.6 [1.6] years) were included in the study. Trauma-focused CBT was more effective than UC for PTS in 3 of 4 sites after treatment (end of 3-month randomized clinical trial): rural Kenya (Cohen d = 1.04 [95% CI, 0.72-1.36]), urban Kenya (Cohen d = 0.56 [95% CI, 0.29-0.83]), and urban Tanzania (Cohen d = 0.45 [95% CI, 0.10-0.80]). At 12-month follow-up, TF-CBT remained more effective than UC in both rural (Cohen d = 0.86 [95% CI, 0.64-1.07]) and urban (Cohen d = 0.99 [95% CI, 0.75-1.23]) Kenya. At 12-month follow-up in Tanzania, children who received TF-CBT and UC had comparable rates of improvement (rural Tanzania, Cohen d = 0.09 [95% CI, -0.08 to 0.26]; urban Tanzania, Cohen d = 0.11 [95% CI, -0.09 to 0.31]). A similar pattern was seen for secondary outcomes, with stronger effects observed in Kenya, where children experienced greater stress and adversity (eg, more food scarcity, poorer guardian health, and greater exposure to traumatic events).
Conclusions and Relevance


This study found that TF-CBT was more effective than UC in reducing PTS among children who experienced parental death in 3 of 4 sites in Kenya and Tanzania. At 12-month follow-up, TF-CBT was more effective in reducing PTS only among children in rural and urban Kenya.
Trial Registration


ClinicalTrials.gov identifier: NCT01822366.",2020,"At 12-month follow-up in Tanzania, children who received TF-CBT and UC had comparable rates of improvement (rural Tanzania, Cohen d = 0.09","['320 children', 'urban and rural areas of Tanzania and Kenya compared', '640 children aged 7 to 13 years who were recruited from February 13, 2013, to July 24, 2015', 'children in Kenya and Tanzania who have experienced parental death', 'children who experienced parental death in 3 of 4 sites in Kenya and Tanzania', '640 children (320 girls and 320 boys; mean [SD] age, 10.6 [1.6] years) were included in the study', 'Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania', '320 children received community services typically offered to this population']","['TF-CBT and usual care (UC', 'UC', 'trauma-focused CBT (TF-CBT', 'Cognitive behavioral therapy (CBT', 'Task-Shifted Trauma-Focused Cognitive Behavioral Therapy', 'TF-CBT']","['stress and adversity (eg, more food scarcity, poorer guardian health, and greater exposure to traumatic events', 'death of one or both parents and had elevated PTS and/or prolonged grief']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524342', 'cui_str': 'Parental Death'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0009482', 'cui_str': 'Services, Community'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0018235', 'cui_str': 'Grief'}]",640.0,0.216778,"At 12-month follow-up in Tanzania, children who received TF-CBT and UC had comparable rates of improvement (rural Tanzania, Cohen d = 0.09","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dorsey', 'Affiliation': 'Department of Psychology, University of Washington, Seattle.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Lucid', 'Affiliation': 'Department of Psychology, University of Washington, Seattle.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Department of Psychology, University of Washington, Seattle.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'King', 'Affiliation': 'Department of Psychology, University of Washington, Seattle.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': ""O'Donnell"", 'Affiliation': 'Center for Child and Family Health, Duke University, Durham, North Carolina.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Augustine I', 'Initials': 'AI', 'LastName': 'Wasonga', 'Affiliation': 'Ace Africa, Bungoma, Kenya.'}, {'ForeName': 'Dafrosa K', 'Initials': 'DK', 'LastName': 'Itemba', 'Affiliation': 'Tanzania Women Research Foundation, Moshi, Tanzania.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychiatry, Allegheny Health Network, Drexel University College of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Manongi', 'Affiliation': 'Institute of Public Health, Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Whetten', 'Affiliation': 'Center for Health Policy and Inequalities Research, Sanford School of Public Policy and Duke Global Health Institute, Duke University, Durham, North Carolina.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4475']
587,31968063,Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,"Importance


Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes.
Objective


To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation.
Design, Setting, and Participants


This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019.
Interventions


Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway.
Main Outcomes and Measures


The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures.
Results


Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups.
Conclusions and Relevance


In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively.
Trial Registration


ClinicalTrials.gov identifier: NCT02502760.",2020,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","['Frail Patients Undergoing Resection of Colorectal Cancer', '298 patients were excluded (not frail [n\u2009=\u2009290], unable to exercise [n\u2009=\u20093], and planned neoadjuvant treatment [n\u2009=\u20095]), and 120 frail patients (Fried Frailty Index,≥2', '110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups', 'patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019', 'frail patients undergoing colorectal cancer resection (predominantly minimally invasive', '418 patients 65 years or older were assessed for eligibility', 'Ten patients were excluded after randomization because they refused surgery (n\u2009=\u20093), died before surgery (n\u2009=\u20093), had no cancer (n\u2009=\u20091), had surgery without bowel resection (n\u2009=\u20091), or were switched to palliative care (n\u2009=\u20092', 'frail patients preoperatively', 'frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation', '110 patients randomized', ' mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery', 'Frail patients']","['prehabilitation program', 'Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery', 'Multimodal Prehabilitation vs Postoperative Rehabilitation']","['30-day Comprehensive Complications Index', '30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures', '30-Day Postoperative Complications', 'Comprehensive Complications Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",110.0,0.282382,"There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference,","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Carli', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bousquet-Dion', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Rashami', 'Initials': 'R', 'LastName': 'Awasthi', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Elsherbini', 'Affiliation': 'Currently a medical student at Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Liberman', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Charlebois', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Ghitulescu', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Morin', 'Affiliation': 'Department of Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jagoe', 'Affiliation': 'Department of Medicine, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Celena', 'Initials': 'C', 'LastName': 'Scheede-Bergdahl', 'Affiliation': 'Department of Anesthesia, McGill Research Centre for Physical Activity and Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Enrico Maria', 'Initials': 'EM', 'LastName': 'Minnella', 'Affiliation': 'Department of Anesthesia, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Julio F', 'Initials': 'JF', 'LastName': 'Fiore', 'Affiliation': 'Department of Surgery, Montreal General Hospital, McGill University Health Centre, Montreal, Quebec, Canada.'}]",JAMA surgery,['10.1001/jamasurg.2019.5474']
588,31926484,Body composition and neuromotor development in the year after NICU discharge in premature infants.,"BACKGROUND


Hypothesis: neuromotor development correlates to body composition over the first year of life in prematurely born infants and can be influenced by enhancing motor activity.
METHODS


Forty-six female and 53 male infants [27 ± 1.8 (sd) weeks] randomized to comparison or exercise group (caregiver provided 15-20 min daily of developmentally appropriate motor activities) completed the year-long study. Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS) were assessed.
RESULTS


AIMS at 1 year correlated with LBM (r = 0.32, p < 0.001) in the whole cohort. However, there was no effect of the intervention. LBM increased by ~3685 g (p < 0.001)); insulin-like growth factor-1 (IGF-1) was correlated with LBM (r = 0.36, p = 0.002). IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125). LBM and bone mineral density were significantly lower and IGF-1 higher in the females at 1 year.
CONCLUSIONS


We found an association between neuromotor development and LBM suggesting that motor activity may influence LBM. Our particular intervention was ineffective. Whether activities provided largely by caregivers to enhance motor activity in prematurely born infants can affect the interrelated (1) balance of growth and inflammation mediators, (2) neuromotor development, (3) sexual dimorphism, and/or (4) body composition early in life remains unknown.",2020,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","['Forty-six female and 53 male infants [27\u2009±\u20091.8 (sd) weeks', 'prematurely born infants', 'premature infants']",['randomized to comparison or exercise group (caregiver provided 15-20\u2009min daily of developmentally appropriate motor activities'],"['IL-1RA (an inflammatory biomarker', 'Body composition [lean body and fat mass (LBM, FM)], growth/inflammation predictive biomarkers, and Alberta Infant Motor Scale (AIMS', 'insulin-like growth factor-1 (IGF-1', 'Body composition and neuromotor development', 'motor activity', 'LBM and bone mineral density', 'LBM']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}]","[{'cui': 'C1704264', 'cui_str': 'IL-1 Inhibitor, Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0222045'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",46.0,0.0798796,"IL-1RA (an inflammatory biomarker) decreased (-75%, p < 0.0125).","[{'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Cooper', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA. dcooper@hs.uci.edu.'}, {'ForeName': 'Gay L', 'Initials': 'GL', 'LastName': 'Girolami', 'Affiliation': 'Department of Physical Therapy, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kepes', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Annamarie', 'Initials': 'A', 'LastName': 'Stehli', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Candice Taylor', 'Initials': 'CT', 'LastName': 'Lucas', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Fadia', 'Initials': 'F', 'LastName': 'Haddad', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zalidvar', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Nitzan', 'Initials': 'N', 'LastName': 'Dror', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Soliman', 'Affiliation': ""Miller Women's and Children's Hospital, Long Beach, CA, USA.""}, {'ForeName': 'Shlomit', 'Initials': 'S', 'LastName': 'Radom-Aizik', 'Affiliation': 'Pediatric Exercise and Genomics Research Center, UC Irvine School of Medicine, Irvine, CA, USA.'}]",Pediatric research,['10.1038/s41390-020-0756-2']
589,31961417,Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial.,"Importance


A prior pilot study demonstrated the systemic absorption of 4 sunscreen active ingredients; additional studies are needed to determine the systemic absorption of additional active ingredients and how quickly systemic exposure exceeds 0.5 ng/mL as recommended by the US Food and Drug Administration (FDA).
Objective


To assess the systemic absorption and pharmacokinetics of the 6 active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate) in 4 sunscreen products under single- and maximal-use conditions.
Design, Setting, and Participants


Randomized clinical trial at a clinical pharmacology unit (West Bend, Wisconsin) was conducted in 48 healthy participants. The study was conducted between January and February 2019.
Interventions


Participants were randomized to 1 of 4 sunscreen products, formulated as lotion (n = 12), aerosol spray (n = 12), nonaerosol spray (n = 12), and pump spray (n = 12). Sunscreen product was applied at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals, and 34 blood samples were collected over 21 days from each participant.
Main Outcomes and Measures


The primary outcome was the maximum plasma concentration of avobenzone over days 1 through 21. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, homosalate, octisalate, and octinoxate over days 1 through 21.
Results


Among 48 randomized participants (mean [SD] age, 38.7 [13.2] years; 24 women [50%]; 23 white [48%], 23 African American [48%], 1 Asian [2%], and 1 of unknown race/ethnicity [2%]), 44 (92%) completed the trial. Geometric mean maximum plasma concentrations of all 6 active ingredients were greater than 0.5 ng/mL, and this threshold was surpassed on day 1 after a single application for all active ingredients. For avobenzone, the overall maximum plasma concentrations were 7.1 ng/mL (coefficient of variation [CV], 73.9%) for lotion, 3.5 ng/mL (CV, 70.9%) for aerosol spray, 3.5 ng/mL (CV, 73.0%) for nonaerosol spray, and 3.3 ng/mL (CV, 47.8%) for pump spray. For oxybenzone, the concentrations were 258.1 ng/mL (CV, 53.0%) for lotion and 180.1 ng/mL (CV, 57.3%) for aerosol spray. For octocrylene, the concentrations were 7.8 ng/mL (CV, 87.1%) for lotion, 6.6 ng/mL (CV, 78.1%) for aerosol spray, and 6.6 ng/mL (CV, 103.9%) for nonaerosol spray. For homosalate, concentrations were 23.1 ng/mL (CV, 68.0%) for aerosol spray, 17.9 ng/mL (CV, 61.7%) for nonaerosol spray, and 13.9 ng/mL (CV, 70.2%) for pump spray. For octisalate, concentrations were 5.1 ng/mL (CV, 81.6%) for aerosol spray, 5.8 ng/mL (CV, 77.4%) for nonaerosol spray, and 4.6 ng/mL (CV, 97.6%) for pump spray. For octinoxate, concentrations were 7.9 ng/mL (CV, 86.5%) for nonaerosol spray and 5.2 ng/mL (CV, 68.2%) for pump spray. The most common adverse event was rash, which developed in 14 participants.
Conclusions and Relevance


In this study conducted in a clinical pharmacology unit and examining sunscreen application among healthy participants, all 6 of the tested active ingredients administered in 4 different sunscreen formulations were systemically absorbed and had plasma concentrations that surpassed the FDA threshold for potentially waiving some of the additional safety studies for sunscreens. These findings do not indicate that individuals should refrain from the use of sunscreen.
Trial Registration


ClinicalTrials.gov Identifier: NCT03582215.",2020,"For octisalate, concentrations were 5.1 ng/mL (CV, 81.6%) for aerosol spray, 5.8 ng/mL (CV, 77.4%) for nonaerosol spray, and 4.6 ng/mL","['48 randomized participants (mean [SD] age', 'January and February 2019', '48 healthy participants', '38.7 [13.2] years; 24 women [50%]; 23 white [48%], 23 African American [48%], 1 Asian [2%], and 1 of unknown race/ethnicity [2%]), 44 (92%) completed the trial', 'healthy participants']","['sunscreen products, formulated as lotion (n\u2009=\u200912), aerosol spray (n\u2009=\u200912), nonaerosol spray (n\u2009=\u200912), and pump spray', 'Sunscreen Application', '6 active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate']","['Geometric mean maximum plasma concentrations', 'maximum plasma concentration of avobenzone', 'overall maximum plasma concentrations', 'maximum plasma concentrations of oxybenzone, octocrylene, homosalate, octisalate, and octinoxate over days 1 through 21', 'Plasma Concentration of Sunscreen Active Ingredients']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C1706745', 'cui_str': 'Aerosol spray (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0097513', 'cui_str': 'avobenzone'}, {'cui': 'C0069803', 'cui_str': 'oxybenzone'}, {'cui': 'C0257715', 'cui_str': 'octocrylene'}, {'cui': 'C0304631', 'cui_str': 'homosalate'}, {'cui': 'C0304632', 'cui_str': 'octisalate'}, {'cui': 'C0046100', 'cui_str': 'Octinoxate'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0097513', 'cui_str': 'avobenzone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0069803', 'cui_str': 'oxybenzone'}, {'cui': 'C0257715', 'cui_str': 'octocrylene'}, {'cui': 'C0304631', 'cui_str': 'homosalate'}, {'cui': 'C0304632', 'cui_str': 'octisalate'}, {'cui': 'C0046100', 'cui_str': 'Octinoxate'}, {'cui': 'C0585022', 'cui_str': 'During day (qualifier value)'}, {'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]",48.0,0.539163,"For octisalate, concentrations were 5.1 ng/mL (CV, 81.6%) for aerosol spray, 5.8 ng/mL (CV, 77.4%) for nonaerosol spray, and 4.6 ng/mL","[{'ForeName': 'Murali K', 'Initials': 'MK', 'LastName': 'Matta', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jeffry', 'Initials': 'J', 'LastName': 'Florian', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Zusterzeel', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Nageswara R', 'Initials': 'NR', 'LastName': 'Pilli', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Donna A', 'Initials': 'DA', 'LastName': 'Volpe', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Division of Pharmaceutical Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Oh', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Bashaw', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Issam', 'Initials': 'I', 'LastName': 'Zineh', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanabria', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kemp', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Godfrey', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Adah', 'Affiliation': 'Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Coelho', 'Affiliation': 'Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Lesley-Anne', 'Initials': 'LA', 'LastName': 'Furlong', 'Affiliation': 'Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ganley', 'Affiliation': 'Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Michele', 'Affiliation': 'Division of Nonprescription Drug Products, Office of Drug Evaluation IV, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Strauss', 'Affiliation': 'Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}]",JAMA,['10.1001/jama.2019.20747']
590,31227386,Promoting Gender Egalitarian Norms and Practices Among Boys in Rural India: The Relative Effect of Intervening in Early and Late Adolescence.,"PURPOSE


Although the importance of exposing adolescent boys to gender transformative programs has been recognized, such programs are limited in India. Studies that assessed the relative effect of intervening in early compared with late adolescence are even more limited. This article examines the differential effect of exposing boys to a gender transformative program in early and late adolescence on their gender role attitudes and practices.
METHODS


We used data from a cluster randomized trial of a gender transformative life-skills education cum sports-coaching program for younger boys (aged 13-14 years) and older boys (aged 15-19 years) (N = 962) and used generalized estimating equation model to examine the differential effect.
RESULTS


The intervention had a greater effect in helping younger than older boys to espouse gender-egalitarian attitudes (β = .669; p < .001 vs. β = .344; p < .001) and attitudes rejecting men's controlling behaviors (β = .973; p < .003 vs. β = .453; p < .088), men's perpetration of wife beating (β = .423; p < .002 vs. β = .282; p < .035), and violence on unmarried girls (β = .332; p < .038 vs. β = .306; p < .045). Younger boys had higher odds of reporting that their peers would respect them for acting in gender-equitable ways (odds ratio [OR] = 2.15; p < .003) compared with older boys (OR = 1.78; p < .014). However, younger boys had lower odds of intervening to stop incidents of violence that they had witnessed, compared with older boys (OR = 2.17; p < .03 vs. OR = 2.56; p < .002). These differences remained significant even when difference in regular exposure to the intervention was adjusted.
CONCLUSIONS


Gender transformative programs are likely to be more effective in changing traditional attitudes and practices among boys if they target them during early adolescence compared with late adolescence.",2020,"However, younger boys had lower odds of intervening to stop incidents of violence that they had witnessed, compared with older boys (OR = 2.17; p < .03 vs. OR = 2.56; p < .002).","['Boys in Rural India', 'younger boys (aged 13-14\xa0years) and older boys (aged 15-19\xa0years', 'β\xa0= .332']",['gender transformative life-skills education cum sports-coaching program'],"[""attitudes rejecting men's controlling behaviors ""]","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4319517', 'cui_str': 'Order rejected (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1831579', 'cui_str': 'Controlling behavior'}]",,0.0497784,"However, younger boys had lower odds of intervening to stop incidents of violence that they had witnessed, compared with older boys (OR = 2.17; p < .03 vs. OR = 2.56; p < .002).","[{'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Population Council, India Habitat Centre, New Delhi, India. Electronic address: agupta@popcouncil.org.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Santhya', 'Affiliation': 'Population Council, India Habitat Centre, New Delhi, India.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.03.007']
591,31559633,Does the time-point of orthodontic space closure initiation after tooth extraction affect the incidence of gingival cleft development? A randomized controlled clinical trial.,"BACKGROUND


Gingival clefts (GCs) develop frequently during orthodontic space closure and may compromise the treatment outcome. This study assessed whether the time-point of orthodontic space closure initiation, after permanent tooth extraction, affects the incidence of GC.
METHODS


In 25 patients requiring bilateral premolar extraction because of orthodontic reasons, one premolar, chosen at random, was extracted 8 weeks before space closure initiation (""delayed movement,"" DM), whereas the contralateral premolar was extracted 1 week before (""early movement,"" EM) (""treatment group""). Presence or absence of GC after 3 and 6 months (""time-point"") was recorded and any association with various parameters (i.e., treatment group, time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure) was statistically assessed.
RESULTS


Twenty-one patients contributing with 26 jaws were finally included in the analysis. Overall, GCs were frequent after 3 (DM: 53.9%; EM: 69.2%) and 6 months (DM: 76.9%; EM: 88.5%). EM (P = 0.014) and larger space closure within the study period (P = 0.001) resulted in a significantly higher incidence of GC. Further, there was a tendency for GC development in the presence of buccal bone dehiscence (P = 0.052) and thin gingival biotype (P = 0.054). ""Fast movers"" (herein cases with a tooth movement ≥1 mm per month) developed a GC in >90% of the cases already after 3 months. ""Slow movers"" developed a GC in 25% and 70% after 3 months and final evaluation, respectively.
CONCLUSIONS


GC development is a frequent finding during orthodontic space closure and seems to occur more frequently with early tooth movement initiation and in ""fast movers.""",2020,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"['Twenty-one patients contributing with 26 jaws were finally included in the analysis', '25 patients requiring bilateral premolar extraction due to orthodontic reasons, one premolar, chosen at random']",[],"['larger space closure', 'buccal bone dehiscence', 'time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0449562', 'cui_str': 'Biotype (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",,0.157475,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bertl', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hemma', 'Initials': 'H', 'LastName': 'Neuner', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Meran', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bertl', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Reich', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nemec', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bruckmann', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stavropoulos', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Bantleon', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}]",Journal of periodontology,['10.1002/JPER.19-0376']
592,31967375,Blue-blocking glasses as additive treatment for mania: Effects on actigraphy-derived sleep parameters.,"Improvement of sleep is a central treatment goal for patients in a manic state. Blue-blocking (BB) glasses as adjunctive treatment hasten overall recovery from mania. This method is an evolvement from dark therapy and builds on the discovery of the blue-light-sensitive retinal ganglion cell that signals daytime to the brain. We report effects of adjunctive BB glasses on actigraphy-derived sleep parameters for manic inpatients as compared to placebo. Hospitalized patients with bipolar disorder in a manic state aged 18-70 years were recruited from five clinics in Norway from February 2012 to February 2015. The participants were randomly allocated to wearing BB glasses or placebo (clear glasses) as an adjunctive treatment from 18:00 to 08:00 hours for seven consecutive nights. Sleep and wake were monitored by actigraphy. From 32 eligible patients, 10 patients in each group qualified for the group analyses. The BB group's mean sleep efficiency was significantly higher at night 5 as compared to the placebo group (92.6% vs. 83.1%, p = .027). The 95% confidence interval (CI) was 89.4%-95.8% in the BB group and 75.9%-90.3% in the placebo group. There were fewer nights of interrupted sleep in the BB group: 29.6% versus 43.8% in the placebo group. The BB group received less-intensive sleep-promoting pharmacological treatment and showed significantly higher sleep efficiency and more consolidated sleep as compared to the placebo group. Our findings suggest sleep-promoting effects through deactivating mechanisms. Adjunctive BB glasses seem to be useful for improving sleep for manic patients in the hospital setting.",2020,The BB group received less-intensive sleep-promoting pharmacological treatment and showed significantly higher sleep efficiency and more consolidated sleep as compared to the placebo group.,"['Hospitalized patients with bipolar disorder in a manic state aged 18-70\xa0years were recruited from five clinics in Norway from February 2012 to February 2015', '32 eligible patients, 10 patients in each group qualified for the group analyses', 'patients in a manic state', 'mania', 'manic inpatients']","['placebo', 'adjunctive BB glasses', 'Blue-blocking (BB) glasses', 'wearing BB glasses or placebo (clear glasses']","['sleep efficiency', 'interrupted sleep', 'Improvement of sleep', 'mean sleep efficiency', 'consolidated sleep']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0775015,The BB group received less-intensive sleep-promoting pharmacological treatment and showed significantly higher sleep efficiency and more consolidated sleep as compared to the placebo group.,"[{'ForeName': 'Tone E G', 'Initials': 'TEG', 'LastName': 'Henriksen', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, Faculty of Psychology, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Ole Bernt', 'Initials': 'OB', 'LastName': 'Fasmer', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Schoeyen', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ieva', 'Initials': 'I', 'LastName': 'Leskauskaite', 'Affiliation': 'Department for Psychosis Treatment, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bjorke-Bertheussen', 'Affiliation': 'Division of Psychiatry, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Ytrehus', 'Affiliation': 'Division of Mental Health Care, Valen Hospital, Fonna Local Health Authority, Haugesund, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Department of Clinical Medicine, Section for Psychiatry, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.'}]",Journal of sleep research,['10.1111/jsr.12984']
593,31581295,Higher Caloric Exposure in Critically Ill Patients Transiently Accelerates Thyroid Hormone Activation.,"INTRODUCTION


The inflammatory response of critical illness is accompanied by nonthyroidal illness syndrome (NTIS). Feeding has been shown to attenuate this process, but this has not been explored prospectively over time in critically ill patients.
OBJECTIVE


To explore the impact of calorie exposure on NTIS over time in critically ill patients.
METHODS


Mechanically ventilated patients with systemic inflammatory response syndrome (SIRS) were randomized to receive either 100% or 40% of their estimated caloric needs (ECN). Thyroid hormones were measured daily for 7 days or until intensive care unit discharge or death. Mixed level regression modeling was used to explore the effect of randomization group on plasma triiodothyronine (T3), reverse triiodothyronine (rT3), thyroxine (T4), and thyroid stimulating hormone (TSH), as well as the T3/rT3 ratio.
RESULTS


Thirty-five participants (n=19 in 100% ECN; n=16 in 40% ECN) were recruited. Adjusting for group differences in baseline T3/rT3 ratio, the parameters defining the fitted curves (intercept, linear effect of study day, and quadratic effect of study day) differed by randomization group (P = 0.001, P = 0.01, and P = 0.02 respectively). Plots of the fitted curves revealed that participants in the 100% ECN group had a 54% higher T3/rT3 ratio on postintervention day 1 compared with the 40% ECN group, a difference which attenuated over time. This was driven by a 23% higher plasma T3 and 10% lower plasma rT3 levels on postintervention 1.
CONCLUSIONS


Higher caloric exposure in NTIS patients transiently attenuates the drop of the plasma T3/rT3 ratio, an effect that is minimized and finally lost over the following 3 days of continued higher caloric exposure.",2020,"This was driven by a 23% higher plasma T3 and 10% lower plasma rT3 levels on post-intervention 1.
","['critically ill patients', 'Mechanically ventilated systemic inflammatory response syndrome (SIRS) patients', 'Thirty-five participants (19 in 100% ECN, 16 in 40% ECN) were recruited']","['T3/rT3', 'calorie exposure on NTIS']","['plasma T3/rT3', 'thyroid hormone activation', 'Thyroid hormones', 'plasma rT3 levels']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0760481', 'cui_str': '(3beta,5alpha,17beta)-17-hydroxyestrane-3-carbonitrile'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4522017', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",35.0,0.385733,"This was driven by a 23% higher plasma T3 and 10% lower plasma rT3 levels on post-intervention 1.
","[{'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'McKeever', 'Affiliation': 'University of Illinois at Chicago, Department of Kinesiology and Nutrition, Chicago, Illinois.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Peterson', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Lateef', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'University of Illinois at Chicago, Department of Epidemiology and Biostatistics, Chicago, Illinois.'}, {'ForeName': 'Tatiana L', 'Initials': 'TL', 'LastName': 'Fonseca', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Barbara M L C', 'Initials': 'BMLC', 'LastName': 'Bocco', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Gustavo W', 'Initials': 'GW', 'LastName': 'Fernandes', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Roehl', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Nowak', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Mozer', 'Affiliation': 'Rush University Medical Center, Department of Clinical Nutrition, Chicago, Illinois.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Bianco', 'Affiliation': 'University of Chicago Medical Center, Section of Adult and Pediatric Endocrinology, Diabetes and Metabolism, Chicago, Illinois.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Braunschweig', 'Affiliation': 'University of Illinois at Chicago, Department of Kinesiology and Nutrition, Chicago, Illinois.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz077']
594,31952623,Effects of monthly buprenorphine extended-release injections on patient-centered outcomes: A long-term study.,"INTRODUCTION


The physical, social, psychological, and economic burden of opioid use disorder (OUD) is substantial. As of the year 2019, the predominant focus of OUD research was outcomes such as retention and abstinence. We report herein the effects of extended-release buprenorphine (BUP-XR), the first FDA-approved subcutaneously injected, monthly treatment for OUD, on patient-centered outcomes.
MATERIALS AND METHODS


Patient-centered outcomes were collected during an open-label safety study of participants with OUD (NCT# 02510014) evaluating BUP-XR. Measures collected during the study included the EQ-5D-5L, SF-36v2, Treatment Effectiveness Assessment (TEA), Addiction Severity Index-Lite (ASI-Lite), employment/insurance status questionnaire, and Medication Satisfaction Questionnaire (MSQ). Changes from baseline to end of study week 49 were analyzed using mixed models for repeated measures. ""Baseline"" was defined as the value collected prior to the first BUP-XR injection. Results presented are for those participants who initiated treatment on BUP-XR during the open-label study and were eligible to receive up to 12 injections.
RESULTS


Four hundred twelve participants were included in analyses; 206 participants discontinued BUP-XR prematurely. Mean EQ-5D-5L scores remained stable from baseline to end of study. Statistically significant improvements from baseline to end of study were noted for the SF-36v2 mental component summary score (difference = 5.0, 95%CI: 3.5-6.5) and 7 of 8 domain scores (P < .05 for all comparisons); the SF-36v2 physical component summary remained stable from baseline to end of study. The TEA total score (difference = 9.3 points, 95%CI: 8.0-10.5) and 4 of 4 domain scores (difference = 2-3 points per domain) significantly improved from baseline to end of study. Significant improvements (P < .05 for all comparisons) on the ASI-Lite were seen for all problem areas except alcohol use from baseline to end of study. Employment rate increased 7% whereas health insurance status remained stable from baseline to end of study. Medication satisfaction measured using the MSQ was >88% at end of study.
CONCLUSIONS


Treatment with BUP-XR monthly injections for up to 12 months in this cohort of treatment-seeking individuals with OUD led to positive PCOs and high treatment satisfaction, which correspond to personal recovery.",2020,"The TEA total score (difference = 9.3 points, 95%CI: 8.0-10.5) and 4 of 4 domain scores (difference = 2-3 points per domain) significantly improved from baseline to end of study.","['patient-centered outcomes', 'participants who initiated treatment on BUP-XR during the open-label study and were eligible to receive up to 12 injections', 'Patient-centered outcomes were collected during an open-label safety study of participants with OUD (NCT# 02510014) evaluating BUP-XR', 'twelve participants were included in analyses; 206 participants discontinued BUP-XR prematurely', 'Four hundred']","['buprenorphine', 'extended-release buprenorphine (BUP-XR']","['Employment rate', 'health insurance status', 'retention and abstinence', 'SF-36v2 mental component summary score', 'Medication satisfaction', 'TEA total score', 'EQ-5D-5L, SF-36v2, Treatment Effectiveness Assessment (TEA), Addiction Severity Index-Lite (ASI-Lite), employment/insurance status questionnaire, and Medication Satisfaction Questionnaire (MSQ', 'Mean EQ-5D-5L scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",412.0,0.0390751,"The TEA total score (difference = 9.3 points, 95%CI: 8.0-10.5) and 4 of 4 domain scores (difference = 2-3 points per domain) significantly improved from baseline to end of study.","[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Family Medicine, David Geffen School of Medicine, University of California, 10833 Le Conte Ave, Los Angeles, CA 90095, United States of America.'}, {'ForeName': 'Vijay R', 'Initials': 'VR', 'LastName': 'Nadipelli', 'Affiliation': 'Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States of America.'}, {'ForeName': 'Caitlyn T', 'Initials': 'CT', 'LastName': 'Solem', 'Affiliation': 'Pharmerit International, 4350 East-West Hwy, Suite 1100, Bethesda, MD 20814, United States of America. Electronic address: csolem@pharmerit.com.'}, {'ForeName': 'Naoko A', 'Initials': 'NA', 'LastName': 'Ronquest', 'Affiliation': 'Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States of America.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Yeh', 'Affiliation': 'Pharmerit International, 300 Washington Street, Newton, MA 02458, United States of America.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Learned', 'Affiliation': 'Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States of America.'}, {'ForeName': 'Vishaal', 'Initials': 'V', 'LastName': 'Mehra', 'Affiliation': 'Artemis Institute for Clinical Research, 770 Washington St #300, San Diego, CA 92103, United States of America.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heidbreder', 'Affiliation': 'Indivior Inc., 10710 Midlothian Turnpike, Suite 430, Richmond, VA 23235, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.11.004']
595,31913413,Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial.,"Importance


Neoadjuvant systemic therapy (NST) is often administered to enable breast-conserving therapy (BCT) in stages II to III breast cancer.
Objectives


To prospectively evaluate the role of NST in conversion from BCT ineligibility to BCT eligibility and to assess the association of response to NST, germline BRCA (gBRCA) status, and region of treatment with surgical choice in women with triple-negative breast cancer (TNBC).
Design, Setting, and Participants


This prespecified secondary analysis of a multicentered, phase 3, double-blind, randomized clinical trial (BrighTNess) enrolled 634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia. Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate. Data were collected from April 1, 2014, to December 8, 2016. This preplanned analysis was performed from January 5, 2018, to October 28, 2019.
Interventions


Study participants were randomized to receive 12 weeks of weekly paclitaxel alone or with the addition of carboplatin and/or veliparib, followed by 4 cycles of doxorubicin hydrochloride and cyclophosphamide.
Main Outcomes and Measures


Surgeons assessed BCT candidacy by clinical and radiographic criteria before and after NST. Surgical choices and whether BCT eligibility was associated with the likelihood of pathologic complete response were then analyzed.
Results


Among the 634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients. Of 141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible. Overall, 342 (68.1%) of 502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible. Patients treated in Europe and Asia were more likely to undergo BCT (odds ratio, 2.66; 95% CI, 1.84-3.84) compared with those treated in North America. Among patients without gBRCA mutation undergoing mastectomy, those treated in North America were more likely to undergo contralateral prophylactic mastectomy (57 of 81 [70.4%] vs 6 of 30 [20.0%]; P < .001). Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
Conclusions and Relevance


This prospective analysis of NST and BCT eligibility in TNBC demonstrates a conversion from BCT ineligibility to BCT eligibility of 53.2%. Lower BCT rates among eligible patients and higher bilateral mastectomy rates among patients without gBRCA mutation in North America merit investigation.
Trial Registration


ClinicalTrials.gov identifier: NCT02032277.",2020,"Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
","['634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients', '141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible', '634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia', '502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible', 'Triple-Negative Breast Cancer', 'Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate', 'women with triple-negative breast cancer (TNBC']","['Neoadjuvant systemic therapy (NST', 'doxorubicin hydrochloride and cyclophosphamide', 'Neoadjuvant Chemotherapy', 'NST', 'paclitaxel alone or with the addition of carboplatin and/or veliparib']","['Lower BCT rates', 'BCT candidacy by clinical and radiographic criteria', 'bilateral mastectomy rates', 'contralateral prophylactic mastectomy', 'Rates of pathologic complete response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II (finding)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0546861', 'cui_str': 'Doxorubicin Hydrochloride'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1958300', 'cui_str': 'veliparib'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0191877', 'cui_str': 'Bilateral mastectomy (procedure)'}, {'cui': 'C1705768'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",634.0,0.17405,"Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38).
","[{'ForeName': 'Mehra', 'Initials': 'M', 'LastName': 'Golshan', 'Affiliation': ""Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Medical Oncology, German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Jens Bodo', 'Initials': 'JB', 'LastName': 'Houber', 'Affiliation': 'Department of Medical Oncology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Medical Oncology, Texas Oncology-Baylor Sammons Cancer Center, US Oncology, Dallas.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medical Oncology, University of California, San Francisco.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'Department of Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maag', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Sullivan', 'Affiliation': 'AbbVie, Inc, North Chicago, Illinois.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Metzger-Filho', 'Affiliation': ""Department of Surgery, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'Von Minckwitz', 'Affiliation': 'Department of Medical Oncology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'Department of Medical Oncology, Virginia Commonwealth University Massey Cancer Center, Richmond.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Sikov', 'Affiliation': 'Department of Medical Oncology, Women and Infants Hospital of Rhode Island, Providence.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Breast Surgery, Helios Klinikum Berlin-Buch, Berlin, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2019.5410']
596,31690536,Short-Term Impacts of Pulse: An App-Based Teen Pregnancy Prevention Program for Black and Latinx Women.,"PURPOSE


Black and Latinx women aged 18-20 years have high rates of unplanned pregnancy. Furthermore, this age group is less likely than school-aged youth to be served by pregnancy prevention programs typically administered in schools. The study's purpose was to assess the effectiveness of a new app-based teen pregnancy prevention program created for this population using an online- and texting-only recruitment and evaluation approach.
METHODS


The study design was a randomized controlled trial with individual-level assignment of 1,304 women aged 18-20 years recruited online. Seventy-six percent of participants were black or Latinx. Women were randomized to the Pulse reproductive health app or a general health app and received regular text messages with program content and reminders to view the app. An intention-to-treat approach was used for analyses, and significance tests were adjusted to account for permuted block random assignment and multiple hypothesis testing. Linear probability models controlling for the baseline measure of each outcome, whether the participant reported ever having vaginal sex, age, and race/ethnicity, assessed program impacts for 1,124 participants 6 weeks after randomization.
RESULTS


Participants who received the intervention were 7.6 percentage points less likely (p = .001) to report having had sex without a hormonal or long-acting contraceptive method. Intervention participants also scored 7.1 percentage points higher on contraceptive knowledge (p = .000) and were 5.7 percentage points more likely to be confident that they can use birth control during every sexual intercourse (p = .027).
CONCLUSIONS


Impacts at 6 weeks are promising, particularly for a self-led intervention with no direct contact with study staff.",2020,"Intervention participants also scored 7.1 percentage points higher on contraceptive knowledge (p = .000) and were 5.7 percentage points more likely to be confident that they can use birth control during every sexual intercourse (p = .027).
","['1,304 women aged 18-20\xa0years recruited online', 'Black and Latinx women aged 18-20\xa0years have high rates of unplanned pregnancy', 'Black and Latinx Women', 'Seventy-six percent of participants were black or Latinx']","['Pulse', 'Pulse reproductive health app or a general health app and received regular text messages with program content and reminders to view the app', 'new app-based teen pregnancy prevention program']",['contraceptive knowledge'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0032968', 'cui_str': 'Pregnancy, Adolescent'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",1304.0,0.131247,"Intervention participants also scored 7.1 percentage points higher on contraceptive knowledge (p = .000) and were 5.7 percentage points more likely to be confident that they can use birth control during every sexual intercourse (p = .027).
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Manlove', 'Affiliation': 'Department of Reproductive Health and Family Formation, Child Trends, Inc., Bethesda, Maryland. Electronic address: jmanlove@childtrends.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cook', 'Affiliation': 'Department of Reproductive Health and Family Formation, Child Trends, Inc., Bethesda, Maryland.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Whitfield', 'Affiliation': 'Department of Reproductive Health and Family Formation, Child Trends, Inc., Bethesda, Maryland.'}, {'ForeName': 'Makedah', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'Department of Reproductive Health and Family Formation, Child Trends, Inc., Bethesda, Maryland.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Martínez-García', 'Affiliation': 'Department of Innovation & Research, Healthy Teen Network, Baltimore, Maryland.'}, {'ForeName': 'Milagros', 'Initials': 'M', 'LastName': 'Garrido', 'Affiliation': 'Department of Innovation & Research, Healthy Teen Network, Baltimore, Maryland.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.08.017']
597,31365151,Randomized controlled trial assessing the impact of everolimus and low-exposure tacrolimus on graft outcomes in kidney transplant recipients.,"This was a single-center, randomized controlled trial assessing the impact of a 3-month (10-16 weeks) conversion to everolimus with low-exposure tacrolimus, as compared to remaining on full exposure tacrolimus with mycophenolate (NCT02096107). Adult kidney transplant recipients with a functioning graft were eligible for participation. Goal troughs in the intervention arm were 2-5 ng/mL for tacrolimus and 3-8 ng/mL for everolimus, with tacrolimus maintained at 5-12 ng/mL in the control arm; 60 were randomized (30 in each arm) and were well matched at baseline; mean age was 51 years and 57% were African-American. At 12-months, fibrosis scores (27.8% tacrolimus/mycophenolate vs 22.9% tacrolimus/everolimus, P = .391), acute rejection rates (7% tacrolimus/mycophenolate vs 3% tacrolimus/everolimus, P = .554), and graft function (mean eGFR tacrolimus/mycophenolate 56 ± 15 vs tacrolimus/everolimus 59 ± 14 mL/min/1.73 m 2  , P = .465) were similar between arms. The everolimus arm had significantly lower rates of CMV infection, severe BK infection, and improved BK viral clearance kinetics, as compared to the MPA arm. In this population, including a significant number of African-Americans, an immunosuppression regimen of everolimus with low-exposure tacrolimus provided similar efficacy to tacrolimus and mycophenolate, with significantly lower rates of BK and CMV.",2019,"The everolimus arm had significantly lower rates of CMV infection, severe BK infection and improved BK viral clearance kinetics, as compared to the MPA arm.","['Adult, kidney transplant recipients with a functioning graft were eligible for participation', 'Kidney Transplant Recipients']","['tacrolimus/mycophenolate', 'mycophenolate', 'mL', 'tacrolimus and mycophenolate', 'tacrolimus', 'tacrolimus and 3-8 ng/mL for everolimus, with tacrolimus', 'Everolimus and Low Exposure Tacrolimus', 'everolimus with low exposure tacrolimus']","['graft function (mean eGFR tacrolimus /mycophenolate', 'acute rejection rates', 'Graft Outcomes', 'fibrosis scores', 'rates of CMV infection, severe BK infection and improved BK viral clearance kinetics', 'rates of BK and CMV']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",60.0,0.15593,"The everolimus arm had significantly lower rates of CMV infection, severe BK infection and improved BK viral clearance kinetics, as compared to the MPA arm.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Taber', 'Affiliation': 'Division of Transplant Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Avudaiappan', 'Initials': 'A', 'LastName': 'Chokkalingam', 'Affiliation': 'Department of Transplant, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Zemin', 'Initials': 'Z', 'LastName': 'Su', 'Affiliation': 'Division of General Internal Medicine, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Self', 'Affiliation': 'Department of Pathology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Department of Pathology, Intermountain Healthcare, Salt Lake City, Utah.'}, {'ForeName': 'Titte', 'Initials': 'T', 'LastName': 'Srinivas', 'Affiliation': 'Transplant Nephrology, Intermountain Healthcare, Salt Lake City, Utah.'}]",Clinical transplantation,['10.1111/ctr.13679']
598,31840323,Effect of Oral Nutrition Supplements and TGF-β2 on Nutrition and Inflammatory Patterns in Patients With Active Crohn's Disease.,"BACKGROUND


Crohn's disease (CD) is often associated with nutrition disorders. Many nutrition therapeutic alternatives have been studied. Nevertheless, the actual role of nutrition therapy is still controversial. The objective of this study was to assess the effects of nutrition supplementation with and without transforming growth factor-beta 2 (TGF-β2) on inflammatory, endoscopic, histopathologic, and nutrition parameters in active CD.
MATERIALS AND METHODS


Thirty-eight patients were allocated into 3 groups: group 1 (patients who received only nutrition orientation), group 2 (nutrition orientation and a normoproteic, normocaloric nutrition supplement), and group 3 (nutrition orientation and the nutritional supplement with TGF-β2). Clinical and nutrition evaluation, C-reactive protein (CRP) levels, and assessment of endoscopic and histologic parameters in the intestinal mucosa were performed before and after nutrition intervention.
RESULTS


The mean follow-up period was 3 months. In the beginning of the study, groups were homogeneous regarding age, gender, CD behavior and localization, and medication in use. In the end of the study, the Clinical Disease Activity Index score was reduced in groups 2 and 3; in group 3, a reduction in CRP levels and an improvement in histologic findings were observed. Among patients who received nutritional supplement, some anthropometric patterns were improved.
CONCLUSION


The results of the study indicate that nutritional supplementation improved nutrition and inflammatory patterns in patients with active CD. However, only patients receiving TGF-β2-enriched formula showed improvement in histologic parameters and significant reduction in CRP levels.",2020,"In the end of the study, the Clinical Disease Activity Index score was reduced in groups 2 and 3; in group 3, a reduction in CRP levels and an improvement in histologic findings were observed.","[""Patients With Active Crohn's Disease"", 'Thirty-eight patients', 'patients with active CD', ""Crohn's disease (CD""]","['Oral Nutrition Supplements and TGF-β2', 'nutritional supplementation', 'only nutrition orientation), group 2 (nutrition orientation and a normoproteic, normocaloric nutrition supplement), and group 3 (nutrition orientation and the nutritional supplement with TGF-β2', 'nutrition supplementation with and without transforming growth factor-beta 2 (TGF-β2']","['histologic findings', 'CRP levels', 'Clinical and nutrition evaluation, C-reactive protein (CRP) levels, and assessment of endoscopic and histologic parameters', 'Clinical Disease Activity Index score', 'inflammatory, endoscopic, histopathologic, and nutrition parameters', 'histologic parameters', 'nutrition and inflammatory patterns']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplement'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0079441', 'cui_str': 'Transforming Growth Factor Beta 2'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",38.0,0.0184359,"In the end of the study, the Clinical Disease Activity Index score was reduced in groups 2 and 3; in group 3, a reduction in CRP levels and an improvement in histologic findings were observed.","[{'ForeName': 'Talita Mayra Resende', 'Initials': 'TMR', 'LastName': 'Ferreira', 'Affiliation': 'Adult Health Post Graduation Program, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Annanda', 'Initials': 'A', 'LastName': 'Albuquerque', 'Affiliation': 'Adult Health Post Graduation Program, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Francisco Guilherme', 'Initials': 'FG', 'LastName': 'Cancela Penna', 'Affiliation': 'Adult Health Post Graduation Program, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Macedo Rosa', 'Affiliation': 'Instituto Alfa de Gastroenterologia, Hospital das Clínicas, Medical School, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Maria Isabel Toulson Davisson', 'Initials': 'MITD', 'LastName': 'Correia', 'Affiliation': 'Department of Surgery, Universidade Federal de Minas Gerais, Medical School, Belo Horizonte, Brazil.'}, {'ForeName': 'Alfredo José Afonso', 'Initials': 'AJA', 'LastName': 'Barbosa', 'Affiliation': 'Department of Pathology, Universidade Federal de Minas Gerais, Medical School, Belo Horizonte, Brazil.'}, {'ForeName': 'Aloísio', 'Initials': 'A', 'LastName': 'Salles Cunha', 'Affiliation': 'Department of Clinical Medicine, Universidade Federal de Minas Gerais, Medical School, Belo Horizonte, Brazil.'}, {'ForeName': 'Maria de Lourdes Abreu', 'Initials': 'MLA', 'LastName': 'Ferrari', 'Affiliation': 'Department of Clinical Medicine, Universidade Federal de Minas Gerais, Medical School, Belo Horizonte, Brazil.'}]",Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition,['10.1002/ncp.10448']
599,31915790,Online polarity-dependent effects of cerebellar transcranial direct current stimulation on motor speed and fine manual dexterity. A randomized controlled trial.,"OBJECTIVES


To investigate the role of cerebellar transcranial direct current stimulation (ctDCS) in modulating cerebellar functions in the motor domains of fine motor dexterity and motor speed. Methods: A single-blind, randomized sham-controlled study was conducted between January and July 2018 at the neuroscience laboratory of Imam Abdulrahman Bin Faisal University. A total of 63 healthy participants were assessed for eligibility. Sixty subjects met the criteria of the study and were randomly divided into 3 groups that received anodal, cathodal or sham ctDCS. Subjects performed 2 motor tasks, The Grooved Pegboard test (GPT) assessed fine manual dexterity and the Finger Tapping Task (FTT) assessed motor speed. Subjects undertook the 2 tasks in a single intervention session while 20 minutes of 2mA ctDCS was administered online. The short form of the Edinburgh Handedness Inventory was used to assess handedness and both tasks were performed first with the dominant and then the non-dominant hand. The primary outcome measures included the time of completion of GPT for fine manual dexterity and the mean number of finger-taps for motor speed of each hand. Results: ANOVA revealed a highly significant polarity dependent Group*Task interaction (p less than 0.01) for FTT scores. ANOVA also revealed a non-significant Group*Task interaction for GPT scores.  Conclusion: Findings indicate that ctDCS has a modulatory effect on motor speed and could be a promising therapeutic intervention for treatment of neurological conditions with motor deficits.",2020,ANOVA revealed a highly significant polarity dependent Group*Task interaction (p less than 0.01) for FTT scores.,"['Sixty subjects met the criteria of the study', '63 healthy participants', 'January and July 2018 at the neuroscience laboratory of Imam Abdulrahman Bin Faisal University']","['ctDCS', 'cerebellar transcranial direct current stimulation', 'cerebellar transcranial direct current stimulation (ctDCS', 'anodal, cathodal or sham ctDCS']","['Grooved Pegboard test (GPT) assessed fine manual dexterity and the Finger Tapping Task (FTT) assessed motor speed', 'FTT scores', 'time of completion of GPT for fine manual dexterity and the mean number of finger-taps for motor speed of each hand', 'motor speed and fine manual dexterity']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521321', 'cui_str': 'Imam'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449804', 'cui_str': 'Number of fingers (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",60.0,0.0646573,ANOVA revealed a highly significant polarity dependent Group*Task interaction (p less than 0.01) for FTT scores.,"[{'ForeName': 'Aysha N', 'Initials': 'AN', 'LastName': 'Kinakool', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Imam Abdulrahman, Bin Faisal University, Dammam, Kingdom of Saudi Arabia. E-mail. ayshakinakool@gmail.com.'}, {'ForeName': 'Turki S', 'Initials': 'TS', 'LastName': 'Abualait', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2020.1.24813']
600,31915800,Spinal direct current stimulation with locomotor training in chronic spinal cord injury.,"Transcutaneous spinal direct current stimulation (tsDCS) is a non-invasive method of stimulating spinal circuits that can modulate and induce changes in corticospinal excitability (CE) in incomplete spinal cord injury (SCI). A double-blinded sham controlled study of 2 male patients (A and B) with SCI was carried out. Patient A received sham and cathodal tsDCS, while Patient B received sham and anodal tsDCS. Four baselines were recorded prior to each arm of stimulation. Outcomes were then measured post each arm of stimulation; 10-meter walk test, modified ashworth scale, berg balance scale, manual muscle testing, and spinal cord independence measure-III. Transcranial magnetic stimulation, assessed motor evoked potentials. Cathodal tsDCS increased the scores in few of the outcome measures and decreased others. Anodal stimulation increased scores in all measures. Motor evoked potentials increased in post-cathode and deteriorated in post-anode. In conclusion, tsDCS modulated gait parameters, spasticity, and CE in incomplete SCI.",2020,Anodal stimulation increased scores in all measures.,"['chronic spinal cord injury', '2 male patients (A and B) with SCI']","['Transcutaneous spinal direct current stimulation (tsDCS', 'sham and cathodal tsDCS, while Patient B received sham and anodal tsDCS', 'locomotor training', 'Cathodal tsDCS']","['stimulation; 10-meter walk test, modified ashworth scale, berg balance scale, manual muscle testing, and spinal cord independence measure-III', 'Motor evoked potentials', 'corticospinal excitability (CE', 'tsDCS modulated gait parameters, spasticity, and CE']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}]",,0.17726,Anodal stimulation increased scores in all measures.,"[{'ForeName': 'Turki S', 'Initials': 'TS', 'LastName': 'Abualait', 'Affiliation': 'Department of Physical Therapy, College of Applied Medical Sciences, Eastern Campus, Imam Abdulrahman Bin Faisal University, Dammam, Kingdom of Saudi Arabia. E-mail. tsabualait@iau.edu.sa.'}, {'ForeName': 'Alaa I', 'Initials': 'AI', 'LastName': 'Ibrahim', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2020.1.24818']
601,31909672,Resting state fMRI reveals differential effects of glucose administration on central appetite signalling in young and old adults.,"BACKGROUND


Healthy aging has been associated with reduced appetite and lower energy intake, which can lead to loss of bodyweight, undernutrition and related health problems. The causes for the decline in caloric intake are multifactorial, involving physiological and non-physiological processes.
AIMS


Here we examined the effect of glucose on brain function in healthy adults as well as age-related, physiological changes in brain responses associated with macronutrient intake.
METHODS


Using a randomized, double-blind, balanced cross-over design, younger ( n  = 16, aged 21-30) and older ( n  = 16, aged 55-78) adults received a drink containing glucose and a taste-matched placebo after an overnight fast. Blood glucose and hunger were assessed at baseline and 20 min post-ingestion, after which participants underwent resting state functional magnetic resonance imaging.
RESULTS


Frequency-dependent changes associated with glucose administration in slow-5 (0.01-0.027 Hz) and slow-4 (0.027-0.073 Hz) amplitude of low-frequency fluctuations (ALFF) and fractional ALFF (fALFF) of the blood oxygen level-dependent (BOLD) signal were investigated within the young healthy adults, and then extended to the older age group. Consistent with previous reports, glucose decreased amplitude in slow-5 fALFF within the left orbitofrontal cortex and insular cortex in the young adults. We observed a significant interaction in slow-5 ALFF and fALFF in the left insula, such that younger participants showed a decrease in BOLD amplitude, whereas older participants showed an increase, after glucose administration. We further observed an interaction in slow-4 ALFF in the occipital region and precuneus, with older participants showing an increase in magnitude of slow-4 ALFF and younger participants showing a decrease in the same measure.
CONCLUSION


These age-related, frequency-dependent changes in the magnitude of the BOLD signal in the insula, a key region related to energy homeostasis following feeding, may point to a change in satiety or homeostatic signalling contributing to behavioural changes in energy intake during senescence.",2020,"We further observed an interaction in slow-4 ALFF in the occipital region and precuneus, with older participants showing an increase in magnitude of slow-4 ALFF and younger participants showing a decrease in the same measure.
","['healthy adults', 'younger ( n  = 16, aged 21-30) and older ( n  = 16, aged 55-78) adults received a', 'young and old adults']","['ALFF and fALFF', 'glucose administration', 'glucose', 'drink containing glucose and a taste-matched placebo']","['low-frequency fluctuations (ALFF) and fractional ALFF (fALFF) of the blood oxygen level-dependent (BOLD) signal', 'Blood glucose and hunger', 'BOLD amplitude', 'central appetite signalling', 'brain function']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.139994,"We further observed an interaction in slow-4 ALFF in the occipital region and precuneus, with older participants showing an increase in magnitude of slow-4 ALFF and younger participants showing a decrease in the same measure.
","[{'ForeName': 'Riccarda', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Centre for Human Psychopharmacology, Faculty of Health, Arts and Design, School of Health Sciences, Swinburne University of Technology, Melbourne, VIC, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'Centre for Human Psychopharmacology, Faculty of Health, Arts and Design, School of Health Sciences, Swinburne University of Technology, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Faculty of Health, Arts and Design, School of Health Sciences, Swinburne University of Technology, Melbourne, VIC, Australia.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119894540']
602,31919501,"Treatment of Perianal Fistulas in Crohn's Disease, Seton Versus Anti-TNF Versus Surgical Closure Following Anti-TNF [PISA]: A Randomised Controlled Trial.","BACKGROUND AND AIMS


Most patients with perianal Crohn's fistula receive medical treatment with anti-tumour necrosis factor [TNF], but the results of anti-TNF treatment have not been directly compared with chronic seton drainage or surgical closure. The aim of this study was to assess if chronic seton drainage for patients with perianal Crohn's disease fistulas would result in less re-interventions, compared with anti-TNF and compared with surgical closure.
METHODS


This randomised trial was performed in 19 European centres. Patients with high perianal Crohn's fistulas with a single internal opening were randomly assigned to: i] chronic seton drainage for 1 year; ii] anti-TNF therapy for 1 year; and iii] surgical closure after 2 months under a short course anti-TNF. The primary outcome was the cumulative number of patients with fistula-related re-intervention[s] at 1.5 years. Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort.
RESULTS


Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised. The study was stopped by the data safety monitoring board because of futility. Seton treatment was associated with the highest re-intervention rate [10/15, versus 6/15 anti-TNF and 3/14 surgical closure patients, p = 0.02]. No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed. Interestingly, in the PISA prospective registry, inferiority of chronic seton treatment was not observed for any outcome measure.
CONCLUSIONS


The results imply that chronic seton treatment should not be recommended as the sole treatment for perianal Crohn's fistulas.",2020,No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed.,"[""patients with perianal Crohn's disease fistulas"", 'Patients declining randomisation due to a specific treatment preference were included in a parallel prospective PISA registry cohort', 'Between September 14, 2013 and November 20, 2017, 44 of the 126 planned patients were randomised', ""Patients with high perianal Crohn's fistulas with a single internal opening"", '19 European centres', ""patients with perianal Crohn's fistula receive medical treatment with anti-TNF""]","['i) chronic seton drainage for 1 year, ii) anti-TNF therapy for 1 year, and iii) surgical closure after 2 months under a short course anti-TNF', 'seton versus anti-TNF versus surgical closure following anti-TNF (PISA', 'chronic seton drainage']","['highest re-intervention rate', 'cumulative number of patients with fistula-related re-intervention(s', 'perianal disease activity and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341395', 'cui_str': ""Perianal Crohn's disease (disorder)""}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442158', 'cui_str': 'Perianal region structure'}, {'cui': 'C0010346', 'cui_str': 'Regional Enteritis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0442158', 'cui_str': 'Perianal region structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}]",,0.112317,No substantial differences in perianal disease activity and quality of life between the three treatment groups were observed.,"[{'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Wasmann', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'E Joline', 'Initials': 'EJ', 'LastName': 'de Groof', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Merel E', 'Initials': 'ME', 'LastName': 'Stellingwerf', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Cyriel Y', 'Initials': 'CY', 'LastName': 'Ponsioen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Krisztina B', 'Initials': 'KB', 'LastName': 'Gecse', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Jeroen M', 'Initials': 'JM', 'LastName': 'Jansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Apollo', 'Initials': 'A', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'Sebastiaan A C', 'Initials': 'SAC', 'LastName': 'van Tuyl', 'Affiliation': 'Department of Gastroenterology and Hepatology, Diakonessenhuis, Utrecht, The Netherlands.'}, {'ForeName': 'David D E', 'Initials': 'DDE', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Surgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Karlien F', 'Initials': 'KF', 'LastName': 'Bruin', 'Affiliation': 'Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Spinelli', 'Affiliation': 'Department of Surgery, Humanitas Research Hospital and Humanitas University, Milan, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital and Humanitas University, Milan, Italy.'}, {'ForeName': 'Jarmila D W', 'Initials': 'JDW', 'LastName': 'van der Bilt', 'Affiliation': 'Department of Surgery, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Marco W', 'Initials': 'MW', 'LastName': 'Mundt', 'Affiliation': 'Department of Gastroenterology and Hepatology, Flevoziekenhuis, Almere, The Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Buskens', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Amsterdam, The Netherlands.'}]",Journal of Crohn's & colitis,['10.1093/ecco-jcc/jjaa004']
603,31904681,"Efficacy and Cost-effectiveness Comparison of 10-Day, 14-Day Sequential Versus 14-Day Triple Therapies for Treating Helicobacter pylori Infection in Egyptian Patients.","GOALS


The aim of this study was to clarify whether 10-day or 14-day sequential therapy (ST) can replace conventional triple therapy (TT) as a first-line treatment in Egypt.
BACKGROUND


Antimicrobial resistance has decreased the eradication rates for Helicobacter pylori infection worldwide.
MATERIALS AND METHODS


Patients who tested positive for H. pylori infection were randomly assigned to the 14-day triple-therapy group (n=34), 10-day ST group (n=34), or 14-day ST group (n=35). Sequential treatment includes lansoprazole 30 mg and amoxicillin 1000 mg, both twice for 5 or 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg, each twice for 5 or 7 days. Triple treatment consists of lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1000 mg, each twice for 14 days. Six weeks after treatment discontinuation, patients were examined by the urea breath test. Eradication rates, the incidence of adverse effects, compliance, and cost-effectiveness were evaluated.
RESULTS


The eradication rate was 90% with 10-day ST, 96.7% with 14-day ST, and 63.3% for TT (P=0.001). Mild tolerated adverse effects occurred in the 3 groups. The cost-effectiveness ratio was 2194 LE, 1241 LE, 1157 LE for standard triple therapy, 10-day, and 14-day ST, respectively.
CONCLUSIONS


Sequential therapies for 10 or 14 days are more cost-effective than standard TT, with 14-day ST being the most cost-effective. Accordingly, ST might replace TT as a first-line treatment for H. pylori infection in Egyptian patients.",2020,Mild tolerated adverse effects occurred in the 3 groups.,"['Egyptian patients', 'Egypt', 'Egyptian Patients', 'Patients who tested positive for H. pylori infection']","['clarithromycin 500\u2009mg, and amoxicillin', 'lansoprazole 30\u2009mg, clarithromycin 500\u2009mg, and tinidazole', 'lansoprazole 30\u2009mg and amoxicillin', '10-day ST', '14-day sequential therapy (ST', '10-Day, 14-Day Sequential Versus 14-Day Triple Therapies', 'lansoprazole']","['cost-effective', 'Efficacy and Cost-effectiveness', 'Eradication rates, the incidence of adverse effects, compliance, and cost-effectiveness', 'Helicobacter pylori Infection', 'Mild tolerated adverse effects', 'cost-effectiveness ratio', 'eradication rate']","[{'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1602204', 'cui_str': 'lansoprazole 30 MG [Prevacid]'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",1157.0,0.0170241,Mild tolerated adverse effects occurred in the 3 groups.,"[{'ForeName': 'Nagwan S', 'Initials': 'NS', 'LastName': 'Farhoud', 'Affiliation': 'Drug and Poison Information Centre, College of Pharmacy.'}, {'ForeName': 'Osama M', 'Initials': 'OM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Clinical Pharmacy, College of Pharmacy.'}, {'ForeName': 'Sherif E', 'Initials': 'SE', 'LastName': 'Ezzat', 'Affiliation': 'Department of Gastroenterology, College of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001278']
604,31568796,Persistence of the clinical effect of grass allergen peptide immunotherapy after the second and third grass pollen seasons.,"BACKGROUND


Grass allergen peptides are in development for the treatment of grass pollen-induced allergic rhinoconjunctivitis. A previous randomized, placebo-controlled study demonstrated that grass allergen peptides significantly improved total rhinoconjunctivitis symptom scores (TRSSs) after posttreatment challenge (PTC) to rye grass in an environmental exposure unit after 1 intervening grass pollen season (GPS1).
OBJECTIVE


We sought to evaluate the efficacy/safety of 4 dosing regimens of grass allergen peptides after a second (GPS2) and third (GPS3) intervening GPS in the environmental exposure unit.
METHODS


Eligible subjects who were randomized in the parent study (GPS1) during the first year of recruitment were invited to participate in GPS2 and GPS3, which took place 1 and 2 years after treatment cessation, respectively. Participants were not treated further, and both participants and study personnel remained blinded. The primary efficacy end point was the change in mean TRSS (reported every 30 minutes) from GPS1 baseline to the follow-up PTC calculated across all time points over days 2 to 4 for GPS2 and across hours 1 to 3 over days 2 to 4 for GPS3. Secondary efficacy end points and safety were also assessed.
RESULTS


One hundred twenty-two and 85 participants were enrolled in GPS2 and GPS3, respectively. A numerically greater, but not statistically significant improvement from baseline in mean TRSS at PTC was observed in the group receiving one 6-nmol intradermal injection every 2 weeks for 14 weeks group compared with the placebo at GPS2 (-6.0 vs -3.6, P = .0535) and GPS3 (-6.2 vs -3.6, P = .1128). Similar findings were observed for the group receiving one 6-nmol intradermal injection every 2 weeks for 14 weeks at GPS3 (-6.4 vs -3.6, P = .0759). No adverse safety signals were detected.
CONCLUSION


Treatment with grass allergen peptides led to an improvement in allergic rhinoconjunctivitis symptoms after 3 intervening GPSs, corresponding to up to 2 years off treatment.",2020,"A previous randomized, placebo-controlled study demonstrated grass allergen peptides significantly improved total rhinoconjunctivitis symptom scores(TRSS) following post-treatment challenges(PTC) to rye grass in an Environmental Exposure Unit(EEU) after one intervening grass pollen season(GPS1).
","['Eligible individuals who were randomized in the parent study(GPS1) during the first year of recruitment were invited to participate in GPS2 and GPS3, which took place 1 and 2 years after treatment cessation respectively', '85 participants were enrolled in GPS2 and GPS3 respectively', 'grass pollen-induced allergic rhinoconjunctivitis(ARC']","['placebo', 'grass allergen peptide immunotherapy']","['total rhinoconjunctivitis symptom scores(TRSS', 'efficacy/safety', 'mean TRSS at PTC', 'adverse safety signals', 'ARC symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018210', 'cui_str': 'Grasses'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015491', 'cui_str': 'factor IX'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}]",85.0,0.334702,"A previous randomized, placebo-controlled study demonstrated grass allergen peptides significantly improved total rhinoconjunctivitis symptom scores(TRSS) following post-treatment challenges(PTC) to rye grass in an Environmental Exposure Unit(EEU) after one intervening grass pollen season(GPS1).
","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Ellis', 'Affiliation': ""Departments of Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada; Allergy Research Unit, Kingston General Health Research Institute, Kingston, Ontario, Canada. Electronic address: ellisa@queensu.ca.""}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Frankish', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Armstrong', 'Affiliation': 'Adiga Life Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Steacy', 'Affiliation': 'Allergy Research Unit, Kingston General Health Research Institute, Kingston, Ontario, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Tenn', 'Affiliation': ""Departments of Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, Ontario, Canada; Allergy Research Unit, Kingston General Health Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pawsey', 'Affiliation': 'Circassia, Oxford, United Kingdom.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Hafner', 'Affiliation': 'Circassia, Oxford, United Kingdom.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.09.010']
605,31829432,G-estimation of structural nested restricted mean time lost models to estimate effects of time-varying treatments on a failure time outcome.,"G-estimation of structural nested models (SNMs) plays an important role in estimating the effects of time-varying treatments with appropriate adjustment for time-dependent confounding. As SNMs for a failure time outcome, structural nested accelerated failure time models (SNAFTMs) and structural nested cumulative failure time models have been developed. The latter models are included in the class of structural nested mean models (SNMMs) and are not involved in artificial censoring, which induces several difficulties in g-estimation of SNAFTMs. Recently, restricted mean time lost (RMTL), which corresponds to the area under a distribution function up to a restriction time, is attracting attention in clinical trial communities as an appropriate summary measure of a failure time outcome. In this study, we propose another SNMM for a failure time outcome, which is called structural nested RMTL model (SNRMTLM) and describe randomized and observational g-estimation procedures that use different assumptions for the treatment mechanism in a randomized trial setting. We also provide methods to estimate marginal RMTLs under static treatment regimes using estimated SNRMTLMs. A simulation study evaluates finite-sample performances of the proposed methods compared with the conventional intention-to-treat and per-protocol analyses. We illustrate the proposed methods using data from a randomized controlled trial for cardiovascular disease with treatment changes. G-estimation of SNRMTLMs is a useful tool to estimate the effects of time-varying treatments on a failure time outcome.",2020,"As SNMs for a failure time outcome, structural nested accelerated failure time models (SNAFTMs) and structural nested cumulative failure time models have been developed.",[],[],[],[],[],[],,0.0852601,"As SNMs for a failure time outcome, structural nested accelerated failure time models (SNAFTMs) and structural nested cumulative failure time models have been developed.","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]",Biometrics,['10.1111/biom.13200']
606,31940011,Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.,"Importance


Behavioral high-risk phenotypes predict the onset of bipolar disorder among youths who have parents with bipolar disorder. Few studies have examined whether early intervention delays new mood episodes in high-risk youths.
Objective


To determine whether family-focused therapy (FFT) for high-risk youths is more effective than standard psychoeducation in hastening recovery and delaying emergence of mood episodes during the 1 to 4 years after an active period of mood symptoms.
Design, Settings, and Participants


This multisite randomized clinical trial included referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II. Recruitment started from October 6, 2011, and ended on September 15, 2016. Independent evaluators interviewed participants every 4 to 6 months to measure symptoms for up to 4 years. Data analysis was performed from March 13 to November 3, 2019.
Interventions


High-risk youths and parents were randomly allocated to FFT (12 sessions in 4 months of psychoeducation, communication training, and problem-solving skills training; n = 61) or enhanced care (6 sessions in 4 months of family and individual psychoeducation; n = 66). Youths could receive medication management in either condition.
Main Outcomes and Measures


The coprimary outcomes, derived using weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery. Secondary outcomes were time to conversion to bipolar disorder I or II and longitudinal symptom trajectories.
Results


All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years) were followed up for a median of 98 weeks (range, 0-255 weeks). No differences were detected between treatments in time to recovery from pretreatment symptoms. High-risk youths in the FFT group had longer intervals from recovery to the emergence of the next mood episode (χ2 = 5.44; P = .02; hazard ratio, 0.55; 95% CI, 0.48-0.92;), and from randomization to the next mood episode (χ2 = 4.44; P = .03; hazard ratio, 0.59; 95% CI, 0.35-0.97) than youths in enhanced care. Specifically, FFT was associated with longer intervals to depressive episodes (log-rank χ2 = 6.24; P = .01; hazard ratio, 0.53; 95% CI, 0.31-0.88) but did not differ from enhanced care in time to manic or hypomanic episodes, conversions to bipolar disorder, or symptom trajectories.
Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes. Clarifying the relationship between changes in family functioning and changes in the course of high-risk syndromes merits future investigation.
Trial Registration


ClinicalTrials.gov identifier: NCT01483391.",2020,"Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes.","['Interventions\n\n\nHigh-risk youths and parents', 'Symptomatic Youths at High Risk for Bipolar Disorder', 'referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II', 'youths who have parents with bipolar disorder', 'All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years', 'high-risk youths']","['Family-Focused Therapy vs Enhanced Usual Care', 'family-focused therapy (FFT', 'psychoeducation, communication training, and problem-solving skills training; n\u2009=\u200961) or enhanced care (6 sessions in 4 months of family and individual psychoeducation', 'standard psychoeducation', 'FFT']","['weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery', 'time to conversion to bipolar disorder I or II and longitudinal symptom trajectories', 'longer intervals to depressive episodes']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443298', 'cui_str': 'Second degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]",127.0,0.142508,"Conclusions and Relevance


Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Denver.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Suddath', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Forgey Borlik', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Sugar', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles (UCLA), Los Angeles.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private practice, Menlo Park, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4520']
607,31908182,Daily blood loss transition after total knee arthroplasty with topical administration of tranexamic acid: Paradoxical blood loss after action of tranexamic acid.,"PURPOSE


The purpose of this study was to compare the daily blood loss transition between groups with and without topical administration of tranexamic acid (TXA) after cruciate retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA).
METHODS


A total of 220 patients undergoing unilateral TKA were enrolled in CR and PS TKAs, which were divided into groups that received topical administration of TXA (TXA group) or without TXA (non-TXA group). Each group in both types of TKA included 55 patients. The daily transition of blood loss was compared between the TXA and the non-TXA groups in CR and PS TKAs. The blood loss was calculated through Nadler formula using the patient's blood volume and hemoglobin reduction rate.
RESULTS


Total blood loss was significantly lower in the TXA group in both CR and PS TKAs ( p  < 0.001, respectively). The blood loss was lower for 0-24 h and 24-48 h after TKA. However, from 48 h to 72 h, it was greater in the TXA group (253.1 vs. 34.6 mL;  p  < 0.001) in CR TKAs. These tendencies were similar in PS TKAs after 48 h (186.2 vs. 134.9 mL,  p  = 0.223).
CONCLUSIONS


Topical administration of TXA for reduction of blood loss seemed to be effective up to 48 h after both CR and PS TKAs. The blood loss after 48 h tended to be even greater in the TXA group. Future studies will be required to identify the pharmacokinetic evidence for this clinical finding.
LEVEL OF EVIDENCE


Level II.",2020,"RESULTS


Total blood loss was significantly lower in the TXA group in both CR and PS TKAs ( p  < 0.001, respectively).",['220 patients undergoing unilateral TKA were enrolled in CR and PS TKAs'],"['tranexamic acid (TXA', 'topical administration of TXA (TXA group) or without TXA', 'cruciate retaining (CR) and posterior stabilized (PS) total knee arthroplasty (TKA', 'tranexamic acid', 'TXA']","['Total blood loss', 'daily transition of blood loss', 'Paradoxical blood loss', 'blood loss']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001566', 'cui_str': 'Drug Administration, Topical'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205310', 'cui_str': 'Paradoxical (qualifier value)'}]",220.0,0.0975924,"RESULTS


Total blood loss was significantly lower in the TXA group in both CR and PS TKAs ( p  < 0.001, respectively).","[{'ForeName': 'Sang Jun', 'Initials': 'SJ', 'LastName': 'Song', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, College of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Dae Kyung', 'Initials': 'DK', 'LastName': 'Bae', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul Sacred Heart General Hospital, Seoul, Korea.'}, {'ForeName': 'Cheol Hee', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Graduate School, Kyung Hee University, Seoul, Korea.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019895816']
608,31870925,A Prospective Randomized Blinded Trial of Remote Ischemic Preconditioning in Children Undergoing Cardiac Surgery.,"Remote ischemic preconditioning (RIPC) has been proposed as an intervention to protect myocardium and attenuate end-organ dysfunction associated with cardiopulmonary bypass. We investigated the effect of RIPC in children undergoing cardiopulmonary bypass involving clinical outcome, cardiac and end-organ function, inflammatory response, and myocardial gene expression. A prospective, investigator-blinded, randomized, controlled trial was performed. Patients were randomized into RIPC or Control; RIPC consisted of three 5-minute cycles of limb ischemia-reperfusion taking place 1 and 12 hours preoperatively. Clinical outcomes included cardiac function, ICU surveillance, and renal function. In addition, inflammatory markers and myocardial gene expression were evaluated. RIPC patients required shorter ICU stay (days), RIPC: 1.8 (0.94-3.88) vs Control: 4.9 (1.63-7.20), P = 0.029. Echocardiography parameters demonstrated reduced biventricular function following surgery showing no difference between groups. A nonsignificant trend for reduced troponin was observed following RIPC: AUC analysis, RIPC: 393.05 (98.85-1038.73) vs Control: 596.10 (225.38-954.24) P = 0.75. B-type natriuretic peptide and renal function parameters were similar between groups. Postoperative TNF-α was significantly reduced after RIPC, RIPC: 15.42 (7.81-114.86) vs Control: 108.98 (42.28-301.19) P = 0.02. Remaining inflammatory markers demonstrated no significant difference between groups. HSP-60 showed lower myocardial expression following RIPC, RIPC: 3.95 (2.69-6.28) vs Control: 6.83 (4.74-8.81), P = 0.05. Expression of other analyzed genes was not influenced by RIPC. RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction. The association between RIPC and ICU stay may be influenced by unaccounted latent variables, including cardiac morphology.",2020,"RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction.","['children undergoing CPB involving', 'children undergoing cardiac surgery']","['limb ischemia-reperfusion taking place one and twelve hours pre-operatively', 'RIPC or control; RIPC', 'RIPC', 'Remote ischaemic preconditioning (RIPC', 'Remote Ischaemic Preconditioning']","['cardiac function, ICU surveillance and renal function', 'BNP and renal function parameters', 'reduced Troponin', 'shorter ICU stay', 'clinical outcome, cardiac and end-organ function, inflammatory response and myocardial gene expression', 'shorter ICU stay and reduced TNF-α', 'myocardial expression', 'protection against cardiac injury or renal dysfunction', 'bi-ventricular function', 'inflammatory markers and myocardial gene expression']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C2945695', 'cui_str': 'Limb ischemia'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]",,0.337321,"RIPC was associated with shorter ICU stay and reduced TNF-α but did not influence other clinical outcomes, not confer protection against cardiac injury or renal dysfunction.","[{'ForeName': 'Maribel Carolina', 'Initials': 'MC', 'LastName': 'Verdesoto Rodriguez', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom. Electronic address: maribelcvr@hotmail.com.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Spenceley', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ilina', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}, {'ForeName': 'Mark H D', 'Initials': 'MHD', 'LastName': 'Danton', 'Affiliation': ""Royal Children's Hospital, Glasgow, United Kingdom.""}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2019.12.004']
609,31405391,Recovery Trajectories of Child and Family Outcomes Following Online Family Problem-Solving Therapy for Children and Adolescents after Traumatic Brain Injury.,"OBJECTIVES


We conducted joint analyses from five randomized clinical trials (RCTs) of online family problem-solving therapy (OFPST) for children with traumatic brain injury (TBI) to identify child and parent outcomes most sensitive to OFPST and trajectories of recovery over time.
METHODS


We examined data from 359 children with complicated mild to severe TBI, aged 5-18, randomized to OFPST or a control condition. Using profile analyses, we examined group differences on parent-reported child (internalizing and externalizing behavior problems, executive function behaviors, social competence) and family outcomes (parental depression, psychological distress, family functioning, parent-child conflict).
RESULTS


We found a main effect for measure for both child and family outcomes [F(3, 731) = 7.35, p < .001; F(3, 532) = 4.79, p = .003, respectively], reflecting differing degrees of improvement across measures for both groups. Significant group-by-time interactions indicated that children and families in the OFPST group had fewer problems than controls at both 6 and 18 months post baseline [t(731) = -5.15, p < .001, and t(731) = -3.90, p = .002, respectively, for child outcomes; t(532) = -4.81, p < .001, and t(532) = -3.80, p < .001, respectively, for family outcomes].
CONCLUSIONS


The results suggest limited differences in the measures' responsiveness to treatment while highlighting OFPST's utility in improving both child behavior problems and parent/family functioning. Group differences were greatest at treatment completion and after extended time post treatment.",2019,Significant group-by-time interactions indicated that children and families in the OFPST group had fewer problems than controls at both 6 and 18 months post baseline [t(731) =,"['359 children with complicated mild to severe TBI, aged 5-18, randomized to', 'F(3, 532) ', 'Children and Adolescents after Traumatic Brain Injury', 'children with traumatic brain injury (TBI']","['online family problem-solving therapy (OFPST', 'Online Family Problem-Solving Therapy', 'OFPST']","['parent-reported child (internalizing and externalizing behavior problems, executive function behaviors, social competence) and family outcomes (parental depression, psychological distress, family functioning, parent-child conflict']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C0424960', 'cui_str': 'Family problems (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity (observable entity)'}, {'cui': 'C0030540', 'cui_str': 'Parent/child conflict (finding)'}]",359.0,0.12849,Significant group-by-time interactions indicated that children and families in the OFPST group had fewer problems than controls at both 6 and 18 months post baseline [t(731) =,"[{'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Allison P', 'Initials': 'AP', 'LastName': 'Fisher', 'Affiliation': ""Division of Pediatric Rehabilitation Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Eloise E', 'Initials': 'EE', 'LastName': 'Kaizar', 'Affiliation': 'Department of Statistics, The Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Keith O', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute, Calgary, Alberta, Canada.""}, {'ForeName': 'H Gerry', 'Initials': 'HG', 'LastName': 'Taylor', 'Affiliation': ""Center for Biobehavioral Health, Nationwide Children's Hospital Research Institute, Columbus, OH 43205-2664, USA.""}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH 45267, USA.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000778']
610,31896121,Plasma ammonia concentrations in extremely low birthweight infants in the first week after birth: secondary analysis from the ProVIDe randomized clinical trial.,"BACKGROUND


Little is known about normative ammonia concentrations in extremely low birthweight (ELBW) babies and whether these vary with birth characteristics. We aimed to determine ammonia concentrations in ELBW babies in the first week after birth and relationships with neonatal characteristics and protein intake.
METHODS


Arterial blood samples for the measurement of plasma ammonia concentration were collected within 7 days of birth from ProVIDe trial participants in six New Zealand neonatal intensive care units.
RESULTS


Three hundred and twenty-two babies were included. Median (range) gestational age was 25.7 (22.7-31.6) weeks. Median (interquartile range (IQR)) ammonia concentration was 102 (80-131) µg/dL. There were no statistically significant associations between ammonia concentrations and birthweight or sex. Ammonia concentrations were weakly correlated with mean total (Spearman's r s  = 0.11, P = 0.047) and intravenous (r s  = 0.13, P = 0.02) protein intake from birth, gestational age at birth (r s  = -0.13, P = 0.02) and postnatal age (r s  = -0.13, P = 0.02).
CONCLUSIONS


Plasma ammonia concentrations in ELBW babies are similar to those of larger and more mature babies and only weakly correlated with protein intake. Currently, recommended thresholds for investigation of hyperammonaemia are appropriate for ELBW babies. Protein intake should not be limited by concerns about potential hyperammonaemia.",2020,ammonia concentration was 102 (80-131) µg/dL. There were no statistically significant associations between ammonia concentrations and birthweight or sex.,"['extremely low birthweight infants', 'Three hundred and twenty-two babies were included', 'trial participants in\xa0six New Zealand neonatal intensive care units']",[],"['ammonia concentration', 'Plasma ammonia concentrations', 'Median (interquartile range (IQR', 'plasma ammonia concentration', 'Ammonia concentrations', 'ammonia concentrations and birthweight or sex']","[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]",[],"[{'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",,0.184577,ammonia concentration was 102 (80-131) µg/dL. There were no statistically significant associations between ammonia concentrations and birthweight or sex.,"[{'ForeName': 'Barbara E', 'Initials': 'BE', 'LastName': 'Cormack', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Lynn', 'Affiliation': ""Neonatal Intensive Care Unit, Christchurch Women's Hospital, Christchurch, New Zealand.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Newborn Intensive Care Unit, Waikato Hospital, Hamilton, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hewson', 'Affiliation': 'Neonatal Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Neonatal Unit, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Broadbent', 'Affiliation': 'Neonatal Intensive Care Unit, Dunedin Hospital, Dunedin, New Zealand.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Webster', 'Affiliation': 'LabPlus, Auckland District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Glamuzina', 'Affiliation': 'National Adult and Paediatric Metabolic Service, Auckland, New Zealand.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Ryder', 'Affiliation': 'National Adult and Paediatric Metabolic Service, Auckland, New Zealand.'}, {'ForeName': 'Frank H', 'Initials': 'FH', 'LastName': 'Bloomfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand. f.bloomfield@auckland.ac.nz.'}]",Pediatric research,['10.1038/s41390-019-0730-z']
611,31877310,Clinical importance of cold polypectomy during the insertion phase in the left side of the colon and rectum: a multicenter randomized controlled trial (PRESECT study).,"BACKGROUND AND AIMS


Colorectal polyps are often detected during the insertion phase of colonoscopy but are commonly removed during the withdrawal phase. We aimed to investigate the clinical advantages of instant removal of colorectal polyps during the insertion phase to determine the appropriate strategy for polyps detected on insertion.
METHODS


This prospective, multicenter, randomized trial targeted patients with at least 1 left-sided polyp <10 mm in size detected unintentionally on endoscope insertion from April 2018 to March 2019. Patients were allocated to the following 2 groups: study group, consisting of patients who had polyp removal instantly on insertion, and control group, comprising patients who had the endoscope inserted to the cecum first and polyps removed subsequently on withdrawal. Carbon dioxide gas insufflation and cold polypectomy were applied to minimize the influences of polypectomy on endoscope insertion. Twenty advanced endoscopists from 7 community-based institutions participated in this trial.
RESULTS


Of 1451 patients enrolled, 220 patients were eligible for full assessment. Mean total procedure time was significantly shorter in the study group (18.9 vs 22.3 minutes, P < .001). Mean pure cecal intubation time and number of polyps per patient were similar between the 2 groups. In the control group, among 107 polyps found during insertion, 48 (45.8%) required reinspection and 7 (6.5%) were completely missed, with an average reinspection time of approximately 3 minutes.
CONCLUSIONS


Polypectomy during the insertion phase in the colon and rectum significantly shortens the total procedure time and eliminates all missed polyps without experiencing any disadvantages.",2020,Polypectomy during the insertion phase in the colon and rectum significantly shortens the total procedure time and eliminates all missed polyps without experiencing any disadvantages.,"['Twenty advanced endoscopists from 7 community-based institutions participated in this trial', 'patients with at least one left-sided polyp <10 mm in size detected unintentionally upon endoscope insertion from April 2018 to March 2019', '1451 patients enrolled, 220 patients were eligible for full assessment']","['polyp removal instantly upon insertion, and the Control group comprised patients who had the endoscope inserted to the cecum first and the polyps were removed subsequently upon withdrawal', 'Carbon dioxide gas insufflation and cold polypectomy', 'Polypectomy', 'cold polypectomy']","['Mean total procedure time', 'Mean pure cecal intubation time and number of polyps per patient', 'total procedure time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4521177', 'cui_str': '(F-18)-AV-1451'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",1451.0,0.0861598,Polypectomy during the insertion phase in the colon and rectum significantly shortens the total procedure time and eliminates all missed polyps without experiencing any disadvantages.,"[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Teramoto', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Aoyama', 'Affiliation': 'Department of Gastroenterology, Aoyama Clinic, Kobe, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Ebisutani', 'Affiliation': 'Department of Gastroenterology, Hyogo Prefectural Kakogawa Medical Center, Kakogawa, Japan.'}, {'ForeName': 'Tsuguhiro', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Gastroenterology, Akashi City Hospital, Akashi, Japan.'}, {'ForeName': 'Hirohisa', 'Initials': 'H', 'LastName': 'Machida', 'Affiliation': 'Department of Internal Medicine, Machida Gastrointestinal Hospital, Osaka, Japan.'}, {'ForeName': 'Shiei', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Kobe Medical Center, Kobe, Japan.'}, {'ForeName': 'Nobufumi', 'Initials': 'N', 'LastName': 'Uchima', 'Affiliation': 'Gastrointestinal Center, Urasoe General Hospital, Urasoe, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Utsumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Tomomasa', 'Initials': 'T', 'LastName': 'Tochio', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan; Department of Gastroenterology, Suzuka Central General Hospital, Suzuka, Japan.'}, {'ForeName': 'Daizen', 'Initials': 'D', 'LastName': 'Hirata', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Mineo', 'Initials': 'M', 'LastName': 'Iwatate', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Santa', 'Initials': 'S', 'LastName': 'Hattori', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Sano', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sano', 'Affiliation': 'Gastrointestinal Center, Sano Hospital, Kobe, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.12.019']
612,31722024,Effect of Intranasal vs Intramuscular Naloxone on Opioid Overdose: A Randomized Clinical Trial.,"Importance


Previous unblinded clinical trials suggested that the intranasal route of naloxone hydrochloride was inferior to the widely used intramuscular route for the reversal of opioid overdose.
Objective


To test whether a dose of naloxone administered intranasally is as effective as the same dose of intramuscularly administered naloxone in reversing opioid overdose.
Design, Setting, and Participants


A double-blind, double-dummy randomized clinical trial was conducted at the Uniting Medically Supervised Injecting Centre in Sydney, Australia. Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017. Eligible clients were aged 18 years or older with a history of injecting drug use (n = 197). Intention-to-treat analysis was performed for all participants who received both intranasal and intramuscular modes of treatment (active or placebo).
Interventions


Clients were randomized to receive 1 of 2 treatments: (1) intranasal administration of naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride 800 μg per 1 mL and intranasal administration of placebo 1 mL.
Main Outcomes and Measures


The primary outcome measure was the need for a rescue dose of intramuscular naloxone hydrochloride (800 μg) 10 minutes after the initial treatment. Secondary outcome measures included time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score greater than or equal to 13.
Results


A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2%) were randomized to intramuscular naloxone dose and 104 (52.8%) to intranasal naloxone dose. Clients randomized to intramuscular naloxone administration were less likely to require a rescue dose of naloxone compared with clients randomized to intranasal naloxone administration (8 [8.6%] vs 24 [23.1%]; odds ratio, 0.35; 95% CI, 0.15-0.66; P = .002). A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone. No major adverse events were reported for either group.
Conclusions and Relevance


This trial showed that intranasally administered naloxone in a supervised injecting facility can reverse opioid overdose but not as efficiently as intramuscularly administered naloxone can, findings that largely replicate those of previous unblinded clinical trials. These results suggest that determining the optimal dose and concentration of intranasal naloxone to respond to opioid overdose in real-world conditions is an international priority.
Trial Registration


anzctr.org.au Identifier: ACTRN12611000852954.",2019,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","['Eligible clients were aged 18 years or older with a history of injecting drug use (n\u2009=\u2009197', 'Clients of the center were recruited to participate from February 1, 2012, to January 3, 2017', 'A total of 197 clients (173 [87.8%] male; mean [SD] age, 34.0 [7.82] years) completed the trial, of whom 93 (47.2', 'Uniting Medically Supervised Injecting Centre in Sydney, Australia']","['anzctr.org.au Identifier', 'intranasal and intramuscular modes of treatment (active or placebo', 'placebo 1 mL.\nMain Outcomes and Measures', 'intramuscular naloxone', 'naloxone hydrochloride 800 μg per 1 mL and intramuscular administration of placebo 1 mL or (2) intramuscular administration of naloxone hydrochloride', 'naloxone', 'Intranasal vs Intramuscular Naloxone', 'intranasal naloxone', 'naloxone hydrochloride']","['Opioid Overdose', 'time to respiratory rate', 'time to Glasgow Coma Scale score', 'time to adequate respiratory rate greater than or equal to 10 breaths per minute and time to Glasgow Coma Scale score']","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0700549', 'cui_str': 'Naloxone Hydrochloride'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439386', 'cui_str': 'breaths per minute'}]",197.0,0.34555,"A 65% increase in hazard (hazard ratio, 1.65; 95% CI, 1.21-2.25; P = .002) for time to respiratory rate of at least 10 and an 81% increase in hazard (hazard ratio, 1.81; 95% CI, 1.28-2.56; P = .001) for time to Glasgow Coma Scale score of at least 13 were observed for the group receiving intranasal naloxone compared with the group receiving intramuscular naloxone.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dietze', 'Affiliation': 'Behaviours and Health Risks Program, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Jauncey', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Salmon', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Burwood, Victoria, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Uniting Medically Supervised Injecting Centre, Kings Cross, New South Wales, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'van Beek', 'Affiliation': 'South Eastern Sydney Local Health District, New South Wales, Australia.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Justice Health Forensic Mental Health Network, New South Wales Health, Randwick, New South Wales, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kerr', 'Affiliation': 'Centre for Quality and Patient Safety, School of Nursing and Midwifery, Deakin University, Geelong, Australia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.14977']
613,31890671,"The effect of  Nigella sativa  oil on serum levels of inflammatory markers, liver enzymes, lipid profile, insulin and fasting blood sugar in patients with non-alcoholic fatty liver.","Background


Non-alcoholic fatty liver disease (NAFLD) is one of the metabolic disturbances associated with inflammation.  Nigella sativa  (NS) seed oil has different chemical compounds including Thymoquinone (TQ), unsaturated fatty acids, and flavonoids. NSs are used as anti-inflammatory and antioxidants in medical sciences. This study aimed to investigate the effect of NS oil on several parameters in serum levels of patients with NAFLD.
Methods


Forty-four patients diagnosed with NAFLD participated in a randomized, double-blind, placebo-controlled clinical trial. Patients were randomly assigned into two groups; one receiving NS oil and the other receiving placebo (paraffin oil), for 8 weeks. Blood samples were taken from the patients at the beginning and the end of the study. Afterwards, liver enzymes (ALT, AST, and GGT), inflammatory markers (Hs-CRP, TNF-α, and IL-6), insulin, lipid profiles (total cholesterol, triglyceride, VLDL, LDL-C, and HDL-C), FBS, and blood pressure were measured.
Results


Consumption of NS seed oil as supplement decreased the FBS level, lipid profiles (TG, TC, LDL, VLDL), liver enzymes (AST and ALT), hs-CRP inflammatory marker, IL-6, TNF-α, while it increased the HDL-C levels, compared to the placebo group ( P  < 0.05). Receiving NS oil had no significant effect on serum levels of insulin, blood pressure, and GGT in comparison with the beginning of the study ( P  < 0.05).
Conclusion


NS seed oil supplements may decrease the liver enzymes and lipid profiles in the patients with NAFLD and play a protective role in the liver via reducing the inflammation in this group of patients.",2019,"Receiving NS oil had no significant effect on serum levels of insulin, blood pressure, and GGT in comparison with the beginning of the study ( P  < 0.05).
","['Methods\n\n\nForty-four patients diagnosed with NAFLD', 'patients with non-alcoholic fatty liver', 'patients with NAFLD']","['NS oil and the other receiving placebo (paraffin oil', 'Nigella sativa  (NS) seed oil', 'placebo', 'Nigella sativa  oil', 'NS oil']","['HDL-C levels', 'FBS level, lipid profiles (TG, TC, LDL, VLDL), liver enzymes (AST and ALT), hs-CRP inflammatory marker, IL-6, TNF-α', 'serum levels of insulin, blood pressure, and GGT', 'liver enzymes (ALT, AST, and GGT), inflammatory markers (Hs-CRP, TNF-α, and IL-6), insulin, lipid profiles (total cholesterol, triglyceride, VLDL, LDL-C, and HDL-C), FBS, and blood pressure', 'serum levels of inflammatory markers, liver enzymes, lipid profile, insulin and fasting blood sugar', 'liver enzymes and lipid profiles']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C3651714', 'cui_str': 'caraway black oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0070062', 'cui_str': 'paraffin oils'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",44.0,0.166729,"Receiving NS oil had no significant effect on serum levels of insulin, blood pressure, and GGT in comparison with the beginning of the study ( P  < 0.05).
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rashidmayvan', 'Affiliation': '1Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': '2Hyperlipidemia Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Seyedian', 'Affiliation': '3Research Institute for Infectious Diseases of the Digestive System, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': '4Department of Health Statistics, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-019-00439-6']
614,31880796,Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial.,"Importance


Insomnia disorder is prevalent and associated with health risks in older adults; however, efficacy and safety issues with existing treatments create significant unmet needs in this patient population.
Objective


To compare treatment with the orexin receptor antagonist lemborexant with placebo and zolpidem tartrate extended release in participants with insomnia disorder.
Design, Setting, and Participants


The Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) clinical trial was a global randomized double-blind parallel-group placebo-controlled active-comparator phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018. Data analyses were conducted from January 31, 2018, to September 10, 2018. Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography. Participants could have also had sleep onset difficulties.
Interventions


Participants received placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant (5 mg or 10 mg) for 1 month at bedtime.
Main Outcomes and Measures


Paired polysomnograms were collected at baseline, the first 2 nights, and the last 2 nights of treatment. The primary end point was the change from baseline in latency to persistent sleep for lemborexant therapy vs placebo. Key secondary end points were changes from baseline in sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset in the second half of the night compared with zolpidem therapy.
Results


Among 1006 participants randomized (placebo, n = 208; zolpidem, n = 263; lemborexant 5 mg, n = 266; and lemborexant 10 mg, n = 269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years). Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001). For nights 29 and 30, as measured using polysomnography, the mean change from baseline in sleep efficiency (LSM treatment difference vs placebo for lemborexant 5 mg, 7.1%; 95% CI, 5.6%-8.5%; P < .001 and for lemborexant 10 mg, 8.0%; 95% CI, 6.6%-9.5%; P < .001) and wake-after-sleep onset (least squares mean treatment ratio vs placebo for lemborexant 5 mg, -24.0 min; 95% CI, -30.0 to -18.0 min; P < .001 and for lemborexant 10 mg, -25.4 min; 95% CI, -31.4 to -19.3 min; P < .001) were significantly greater for both doses of lemborexant therapy compared with placebo. Also, for nights 29 and 30, wake-after-sleep onset in the second half of the night (least squares mean treatment difference vs zolpidem for lemborexant 5 mg, -6.7 min; 95% CI, -11.2 to -2.2 min; P = .004 and for lemborexant 10 mg, -8.0 min; 95% CI, -12.5 to -3.5 min; P < .001) was significantly greater for both doses of lemborexant therapy compared with zolpidem therapy measured using polysomnography. Six participants (4 in the zolpidem group and 2 in the lemborexant 5 mg group) reported serious adverse events; none were treatment-related. Other adverse events were mostly mild or moderate in severity.
Conclusions and Relevance


In this randomized clinical trial, lemborexant therapy significantly improved both sleep onset and sleep maintenance, including in the second half of the night, compared with both placebo and zolpidem measured objectively using polysomnography. Lemborexant therapy was well tolerated.
Trial Registrations


ClinicalTrials.gov identifier: NCT02783729; EudraCT identifier: 2015-001463-39.",2019,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","['phase 3 study conducted at 67 sites in North America and Europe from May 31, 2016, to January 30, 2018', '1006 participants randomized', 'older adults', '10 mg, n\u2009=\u2009269), 869 (86.4%) were women and the median age was 63 years (range, 55-88 years', 'Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1', 'Older Adults With Insomnia Disorder', 'participants with insomnia disorder', 'Participants were 55 years and older with insomnia disorder characterized by reported sleep maintenance difficulties and confirmed by sleep history, sleep diary, and polysomnography']","['zolpidem', 'placebo and zolpidem', 'orexin receptor antagonist lemborexant with placebo and zolpidem tartrate', 'Lemborexant With Placebo', 'Zolpidem Tartrate', 'placebo, zolpidem tartrate extended release (6.25 mg), or lemborexant', 'zolpidem, n\u2009=\u2009263; lemborexant 5 mg, n\u2009=\u2009266; and lemborexant', 'Lemborexant therapy', 'placebo', 'Lemborexant', 'placebo-controlled active-comparator', 'lemborexant therapy vs placebo', 'lemborexant therapy']","['serious adverse events', 'sleep efficiency', 'objective sleep onset', 'sleep onset difficulties', 'sleep efficiency and wake-after-sleep onset compared with placebo, and wake-after-sleep onset', 'sleep onset and sleep maintenance', 'latency to persistent sleep', 'tolerated']","[{'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019081', 'cui_str': 'Orexin Receptor Blockers'}, {'cui': 'C0724725', 'cui_str': 'Zolpidem tartrate'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4517821', 'cui_str': '6.25'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",1006.0,0.534433,"Both doses of lemborexant therapy demonstrated statistically significant greater changes from baseline on objective sleep onset as assessed by latency to persistent sleep (log transformed) that was measured using polysomnography at the end of 1 month of treatment (nights 29 and 30) compared with placebo (primary end point for least squares geometric means treatment ratio vs placebo: for lemborexant 5 mg, 0.77; 95% CI, 0.67-0.89; P < .001; for lemborexant 10 mg, 0.72; 95% CI, 0.63-0.83; P < .001).","[{'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Rosenberg', 'Affiliation': 'NeuroTrials Research, Atlanta, Georgia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': 'ICON, North Wales, Pennsylvania.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'Community Research, Cincinnati, Ohio.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Dhadda', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Filippov', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'LoPresti', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Moline', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18254']
615,31232675,Female Athlete Body Project Intervention with Professional Dancers: A Pilot Trial.,"As aesthetic athletes, professional dancers have increased vulnerability for eating disorders (EDs), with three times higher risk than non-dancers. Among ballet dancers, generalized risk for EDs associated with internalization of western cultural female beauty ideals is compounded by idealization of a ballet-specific body ideal, a combination that confers unique vulnerability for eating pathology. Empirical support has been established for an athlete-specific intervention promoting body acceptance and reduced eating pathology among general populations of young-adult women and female collegiate athletes; the current study adapted this intervention for pilot implementation among professional ballet dancers. Participants from two elite ballet companies ( N  = 19) were randomized to a control and intervention condition. All participants self-reported eating pathology and related variables pre- and post-intervention, and at six-week follow-up. Post-intervention, participants receiving the intervention demonstrated reductions in body dissatisfaction,  p  = .005,  r  = -.63, dietary restraint,  p  = .008,  r  = -.59, and eating pathology,  p  = .007,  r  = -.60, as compared to control group counterparts; significant differences were retained at follow-up. Results provide preliminary evidence that this intervention has the potential to provide a feasible and acceptable means of ED prevention in female professional ballet dancers. Barriers to feasibility are identified and discussed.",2019,"Post-intervention, participants receiving the intervention demonstrated reductions in body dissatisfaction,  p  = .005,  r  = -.63, dietary restraint,  ","['Female Athlete Body Project Intervention with Professional Dancers', 'Participants from two elite ballet companies ( N  = 19', 'young-adult women and female collegiate athletes']",[],['body dissatisfaction'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0335081', 'cui_str': 'Dancer (occupation)'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],[],19.0,0.0209316,"Post-intervention, participants receiving the intervention demonstrated reductions in body dissatisfaction,  p  = .005,  r  = -.63, dietary restraint,  ","[{'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Gorrell', 'Affiliation': 'a Department of Psychology , University at Albany, State University of New York , Albany , NY , USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Schaumberg', 'Affiliation': 'c Department of Psychology , University of Wisconsin , Madison , WI , USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'a Department of Psychology , University at Albany, State University of New York , Albany , NY , USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'a Department of Psychology , University at Albany, State University of New York , Albany , NY , USA.'}, {'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Anderson', 'Affiliation': 'a Department of Psychology , University at Albany, State University of New York , Albany , NY , USA.'}]",Eating disorders,['10.1080/10640266.2019.1632592']
616,31777210,Immersive simulation training at 6-week intervals for 1 year and multidisciplinary team performance scores: a randomized controlled trial of simulation training for life-threatening pediatric emergencies.,"OBJECTIVES


To demonstrate an effect of 1 year of training using immersive simulations repeated every 6 weeks versus every 6 months to improve the performance of multidisciplinary teams (MDTs) working with children in lifethreatening situations.
MATERIAL AND METHODS


Randomized controlled trial in 12 MDTs of emergency responders in France. Each MDT consisted of 4 persons: a physician, a resident, a nurse, and the ambulance driver. Six MDTs participated in 9 different high-fidelity simulations of pediatric shock over the course of a year. Six control MDTs were presented with 3 of the experimental group's simulations at 3 time points (starting point, 6 months, and 1 year). Technical performance was assessed with the Team Average Performance Assessment Scale (TAPAS) and an intraosseous (IO) access performance scale. Nontechnical performance assessment instruments were the Clinical Teamwork Scale (CTS) and, for leadership, the Behavioral Assessment Tool (BAT). Progress over time was analyzed by comparing the 2 groups during the 3 simulations they experienced in common.
RESULTS


Performance scores rose significantly over the study period in the experimental group (P=.01 for the TAPAS score, P=.008 for IO access, P=.03 for the CTS score, and P=.02 for the BAT score) but did not change in the control group (P=.46 for TAPAS, P=.55 for IO access, P=.62 for CTS, and P=.58 for BAT). All mean (SD) scores were higher in the experimental group than in the control group in the last session: TAPAS, 55.8 ± 6.3 vs 31.2 ± 10.3, P=.01; IO access, 91.7 ± 8.0 vs 62.9 ± 16.2, P=.01; CTS, 63.2 ± 9.3 vs 47.2 ± 13.1, P=.03; and BAT, 72.8 ± 5.1 vs 51.2 ± 14.3, P=.01). The 6-month assessment showed significant between-group differences on 2 technical performance measures (P=.02 for TAPAS and P=.03 for IO access); the experimental group's scores were higher. We also observed close correlations between the performance of the leader and the group on both nontechnical (rho > 0.9) and technical (rho > 0.7) assessments.
CONCLUSION


Simulation-based training should be repeated more than 3 times per year. Our findings suggest the advisability of repeating simulations of infrequent, high-risk scenarios every 6 weeks to improve all performance scores and guarantee acceptable technical and nontechnical performance throughout the year.",2019,"RESULTS


Performance scores rose significantly over the study period in the experimental group (P=.01 for the TAPAS score, P=.008 for IO access,","['life-threatening pediatric emergencies', '12 MDTs of emergency responders in France']","['simulation training', 'Immersive simulation training']","['performance scores and guarantee acceptable technical and nontechnical performance', 'Clinical Teamwork Scale (CTS) and, for leadership, the Behavioral Assessment Tool (BAT', 'Technical performance', 'Team Average Performance Assessment Scale (TAPAS) and an intraosseous (IO) access performance scale', 'All mean (SD) scores', 'Performance scores', '2 technical performance measures']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C3178988', 'cui_str': 'First Responders'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0008139', 'cui_str': 'Bats'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0729099,"RESULTS


Performance scores rose significantly over the study period in the experimental group (P=.01 for the TAPAS score, P=.008 for IO access,","[{'ForeName': 'Daniel Aiham', 'Initials': 'DA', 'LastName': 'Ghazali', 'Affiliation': 'Emergency Department and Emergency Medical Service, University Hospital of Bichat, París, Francia. Ilumens, Simulation Center, University of Paris-Diderot, París, Francia.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fournier', 'Affiliation': 'Pediatric and Congenital Cardiology Unit, University Hospital of Bordeaux, Francia.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Breque', 'Affiliation': 'ABS Lab, Simulation Center, Faculty of Medicine, University of Poitiers, Francia.'}, {'ForeName': 'Stéphanie Pharmad', 'Initials': 'SP', 'LastName': 'Ragot', 'Affiliation': 'Statistical Department and Clinical Investigation Center (CIC 1402), INSERM (French National Health and Medical Research Institute), University Hospital of Poitiers, Francia.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Oriot', 'Affiliation': 'ABS Lab, Simulation Center, Faculty of Medicine, University of Poitiers, Francia. Pediatric Emergency Department, University Hospital of Poitiers, Francia.'}]",Emergencias : revista de la Sociedad Espanola de Medicina de Emergencias,[]
617,31777212,Effectiveness of medical expulsive therapy with the ɲ-adrenergic blocker tamsulosin for distal ureterolithiasis in adults attended in an emergency department in Chile.,"OBJECTIVES


To assess the effectiveness of medical expulsive therapy with tamsulosin.
MATERIAL AND METHODS


Randomized double-blind controlled trial in an emergency department. We enrolled adults with uncomplicated distal ureterolithiasis and no other complaint. Patients were randomized to take either tamsulosin (0.4 mg/d) plus a nonsteroidal anti-inflammatory drug (NSAID) or placebo plus the NSAID for 21 days.
RESULTS


The stone expulsion rate did not differ statistically between the 2 groups (P=.29). Time until expulsion was also similar (P=.91).
CONCLUSION


Medical expulsive therapy with tamsulosin does not improve the rate of distal ureteral stone expulsion.",2019,The stone expulsion rate did not differ statistically between the 2 groups (P=.29).,"['adults attended in an emergency department in Chile', 'enrolled adults with uncomplicated distal ureterolithiasis and no other complaint']","['tamsulosin', 'nonsteroidal anti-inflammatory drug (NSAID) or placebo', 'medical expulsive therapy with the ɲ-adrenergic blocker tamsulosin']","['Time until expulsion', 'rate of distal ureteral stone expulsion', 'stone expulsion rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0008107', 'cui_str': 'Chile'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242889', 'cui_str': 'Adrenergic Receptor Blockaders'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}]",,0.0813513,The stone expulsion rate did not differ statistically between the 2 groups (P=.29).,"[{'ForeName': 'Gastón', 'Initials': 'G', 'LastName': 'Astroza Eulufi', 'Affiliation': 'Departamento de Urología, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sarrás Jadue', 'Affiliation': 'Departamento de Urología, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Cristóbal', 'Initials': 'C', 'LastName': 'Bettancourt Guglielmetti', 'Affiliation': 'Departamento de Urología, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Bárbara', 'Initials': 'B', 'LastName': 'Lara Hernández', 'Affiliation': 'Servicio de Urgencias, Hospital Clínico, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Neira Soto', 'Affiliation': 'Departamento de Urología, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Aguilera Fuenzalida', 'Affiliation': 'Servicio de Urgencias, Hospital Clínico, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.'}]",Emergencias : revista de la Sociedad Espanola de Medicina de Emergencias,[]
618,31879077,"Effects of protein supplementation on aerobic training-induced gains in cardiopulmonary fitness, muscle mass, and functional performance in chronic stroke: A randomized controlled pilot study.","BACKGROUND & AIMS


The beneficial effects of protein supplementation on aerobic exercise-induced gains in patients with stroke are currently unknown. This study evaluated the feasibility and potential value of protein supplementation with aerobic exercise among stroke survivors.
METHODS


This double-blinded randomized controlled pilot study included 20 ambulatory persons with chronic (>6 months) stroke randomly assigned to either the protein (PRO) or carbohydrate (CHO) group. All participants received three 40-min cycling ergometric training sessions a week for 8 weeks. Training intensity at 60%-80% heart rate reserve was determined using cardiopulmonary exercise pretests. Immediately before and after each session, the PRO group received a 20-g protein-rich supplement, and the CHO group received a 20-g calorie-matched carbohydrate-rich supplement. Outcomes included changes in body composition, cardiopulmonary capacity, and clinical functional performance.
RESULTS


Those completing the protocol (n = 18) received 18-24 cycling training sessions, achieving target training intensity without major adverse effects. Of the two groups, the PRO group tended to obtain greater aerobic capacity (effect size [ES]>0.5 in every cardiopulmonary index), greater improvements in functional performance (0.25 < ES < 1.00 in various clinical tests), and greater total lean mass versus total fat mass (ES = 0.52).
CONCLUSIONS


Protein supplementation with aerobic exercise training tends to improve body composition, cardiopulmonary fitness, and function among persons with stroke. This study protocol is feasible, and future trials with larger sample sizes could confirm these results.
TRIAL REGISTRATION


NCT03244527.",2020,"Of the two groups, the PRO group tended to obtain greater aerobic capacity (effect size [ES]>0.5 in every cardiopulmonary index), greater improvements in functional performance (0.25 < ES ","['chronic stroke', 'persons with stroke', 'patients with stroke', '20 ambulatory persons with chronic (>6 months) stroke randomly assigned to either the', 'stroke survivors']","['40-min cycling ergometric training sessions', 'protein (PRO) or carbohydrate (CHO', 'protein supplementation with aerobic exercise', '20-g protein-rich supplement, and the CHO group received a 20-g calorie-matched carbohydrate-rich supplement', 'aerobic exercise training', 'protein supplementation']","['body composition, cardiopulmonary fitness, and function', 'aerobic exercise-induced gains', 'functional performance', 'cardiopulmonary fitness, muscle mass, and functional performance', 'changes in body composition, cardiopulmonary capacity, and clinical functional performance', 'aerobic capacity', 'total lean mass versus total fat mass']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",20.0,0.0705294,"Of the two groups, the PRO group tended to obtain greater aerobic capacity (effect size [ES]>0.5 in every cardiopulmonary index), greater improvements in functional performance (0.25 < ES ","[{'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: heathcyh@gmail.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City, Taiwan; Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan. Electronic address: nsweili@gmail.com.'}, {'ForeName': 'Wing P', 'Initials': 'WP', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: wingchan@w.tmu.edu.tw.'}, {'ForeName': 'Chih-Yang', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: hsumacher@icloud.com.'}, {'ForeName': 'Shih-Wei', 'Initials': 'SW', 'LastName': 'Huang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shuang-Ho Hospital, Taipei Medical University, New Taipei City, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: 13001@s.tmu.edu.tw.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan. Electronic address: demiwang0628xx@gmail.com.'}, {'ForeName': 'Yen-Nung', 'Initials': 'YN', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan. Electronic address: semitune@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.12.013']
619,31899037,"Effects of a whole diet approach on metabolic flexibility, insulin sensitivity and postprandial glucose responses in overweight and obese adults - A randomized controlled trial.","BACKGROUND & AIMS


Metabolic flexibility is the ability to adapt fuel oxidation to fuel availability. Metabolic inflexibility has been associated with obesity, the metabolic syndrome and insulin resistance, and can be improved by exercise or weight loss. Dietary changes can modulate metabolic flexibility; however, the effect of a whole diet approach on metabolic flexibility has never been studied. Therefore, our objective was to assess the effect of a healthy diet (HD), as compared to a typical Western diet (WD), on several fasting and postprandial markers of metabolic flexibility and insulin sensitivity.
METHODS


In this parallel randomized trial, overweight or obese men and women (50-70 years; BMI 25-35 kg/m 2 ) consumed a healthy diet (HD; high in fruits and vegetables, pulses, fibers, nuts, fatty fish, and low in high-glycemic carbohydrates; n = 19) or a typical Western diet (WD; n = 21) for six weeks, following a two-week run-in period. The change in respiratory quotient upon insulin stimulation (ΔRQ), and insulin sensitivity, expressed as the M-value, were both determined with a hyperinsulinemic euglycemic clamp. Additionally, other fasting and postprandial markers of metabolic flexibility were assessed during a 5-h high-fat high-glycemic mixed meal challenge.
RESULTS


ΔRQ (p = 0.730) and insulin sensitivity (p = 0.802) were not significantly affected by diet. Postprandial RQ did also not show significant differences (p = 0.610), whereas postprandial glucose excursions were significantly higher in the HD group at T30 (p = 0.014) and T45 (p = 0.026) after mixed meal ingestion (p = 0.037). Fasting glucose (p = 0.530) and HbA1c (p = 0.124) remained unchanged, whereas decreases in fasting insulin (p = 0.038) and the HOMA-IR (p = 0.050) were significantly more pronounced with the HD.
CONCLUSION


A healthy diet for six weeks, without further life-style changes, did not improve metabolic flexibility and whole-body insulin sensitivity, when compared to a Western-style diet. It remains to be determined whether the short time increase in postprandial glucose is physiologically relevant or detrimental to metabolic health. This trial was registered at clinicaltrials.gov as NCT02519127.",2020,"Postprandial RQ did also not show significant differences (p = 0.610), whereas postprandial glucose excursions were significantly higher in the HD group at T30 (p = 0.014) and T45 (p = 0.026) after mixed meal ingestion (p = 0.037).","['overweight and obese adults', 'overweight or obese men and women (50-70 years; BMI 25-35\xa0kg/m 2 ']","['healthy diet (HD', 'healthy diet (HD; high in fruits and vegetables, pulses, fibers, nuts, fatty fish, and low in high-glycemic carbohydrates; n\xa0=\xa019) or a typical Western diet', 'whole diet approach']","['fasting and postprandial markers of metabolic flexibility', 'Fasting glucose', 'ΔRQ', 'metabolic flexibility, insulin sensitivity and postprandial glucose responses', 'insulin sensitivity', 'Postprandial RQ', 'fasting insulin', 'postprandial glucose excursions', 'metabolic flexibility and whole-body insulin sensitivity', 'metabolic flexibility', 'change in respiratory quotient upon insulin stimulation (ΔRQ), and insulin sensitivity, expressed as the M-value', 'HOMA-IR']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C3849996', 'cui_str': 'Western Dietary Pattern'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0417367,"Postprandial RQ did also not show significant differences (p = 0.610), whereas postprandial glucose excursions were significantly higher in the HD group at T30 (p = 0.014) and T45 (p = 0.026) after mixed meal ingestion (p = 0.037).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fechner', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands. Electronic address: e.fechner@maastrichtuniversity.nl.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Bilet', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Harry P F', 'Initials': 'HPF', 'LastName': 'Peters', 'Affiliation': 'Unilever Food Innovation Center, Wageningen, the Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Hiemstra', 'Affiliation': 'Unilever Food Innovation Center, Wageningen, the Netherlands.'}, {'ForeName': 'Doris M', 'Initials': 'DM', 'LastName': 'Jacobs', 'Affiliation': 'Unilever Food Innovation Center, Wageningen, the Netherlands.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': ""Op 't Eyndt"", 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Kornips', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schrauwen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, Maastricht, the Netherlands. Electronic address: p.schrauwen@maastrichtuniversity.nl.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.12.010']
620,31883905,The Effects of a Dysmenorrhea Support Program on University Students Who Had Primary Dysmenorrhea: A Randomized Controlled Study.,"STUDY OBJECTIVE


This study aims to determine the results of a cognitive-behavioral approach in a dysmenorrhea support program that covers the symptoms, acquaintance, and attitudes toward menstruation of university students who had primary dysmenorrhea.
DESIGN AND SETTING


This randomized controlled, prospective, experimental study was carried out in a nursing school using a pretest-posttest design.
PARTICIPANTS


A total of 682 female nursing students and 584 volunteers from the 2017-2018 academic year participated in a study of the prevalence of primary dysmenorrhea (94.0%). Study subjects were first-year female nursing students who scored severe on a visual analog scale for primary dysmenorrhea. As a result of the analysis, 80 female nursing students were assigned to study and control groups. A total of 60 students, 29 in the study group and 31 in the control group, completed the study.
INTERVENTION


The study group participated in a 6-session cognitive-behavioral approach in a dysmenorrhea support program. No intervention was administered to the control group. The control group and the study group were followed by using data collection forms during three menstrual cycles.
OUTCOME MEASURES


The Participant Introductory Form (PIF), Dysmenorrhea Follow-up Form (DFF), Dysmenorrhea Information Form (DIF), Functional and Emotional Dysmenorrhea Scale (FEDS), Visual Analog Scale (VAS), and Menstrual Attitude Questionnaire (MAQ) were used to measure outcomes.
RESULTS


In the case of primary dysmenorrhea, the use of nonpharmacological methods was higher in the study group than in the control group. In the third cycle, although the rate of analgesics use was 20.7% in the study group, it was 50% in the control group. Primary dysmenorrhea symptoms, pain levels, and analgesic use decreased. No change was observed in the attitude toward menstruation.
CONCLUSION


A cost-effective, reliable, cognitive-behavioral approach-based dysmenorrhea support program can be used to relieve symptoms, decrease the use of analgesics, and increase knowledge about primary dysmenorrhea.",2020,"In the case of primary dysmenorrhea, the use of nonpharmacological methods was higher in the study group than in the control group.","['Who Had Primary Dysmenorrhea', 'university students who had primary dysmenorrhea', 'Six hundred eighty-two female nursing students, 584 volunteers, from the 2017-2018 academic year participated in the study conducted for the prevalence of primary dysmenorrhea (94.0', 'Sixty students, 29 in the study group and 31 in the control group, completed the study', '80 female nursing students', 'University Students', 'Study subjects were first year female nursing students who scored severe on a Visual Analog Scale for primary dysmenorrhea']","['cognitive-behavioral approach', 'Dysmenorrhea Support Program']","['Primary dysmenorrhea symptoms, pain levels, and analgesic use decreased', 'rate of analgesics use', 'attitude toward menstruation']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}]",584.0,0.0216974,"In the case of primary dysmenorrhea, the use of nonpharmacological methods was higher in the study group than in the control group.","[{'ForeName': 'Busra', 'Initials': 'B', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Gynecologic and Obstetrics Nursing, Istanbul University-Cerrahpaşa, Florence Nightingale Nursing Faculty, Istanbul, Turkey. Electronic address: ylmzbsr678@gmail.com.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'Sahin', 'Affiliation': 'Department of Gynecologic and Obstetrics Nursing, Istanbul University-Cerrahpaşa, Florence Nightingale Nursing Faculty, Istanbul, Turkey.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2019.12.008']
621,31882232,Nutritional risk screening (NRS 2002) is a strong and modifiable predictor risk score for short-term and long-term clinical outcomes: secondary analysis of a prospective randomised trial.,"INTRODUCTION


The Nutritional Risk Screening 2002 (NRS 2002) identifies patients at risk of malnutrition. We studied the prognostic implications of this score with regard to short-term and long-term clinical outcomes in a well-characterised cohort of medical inpatients from a previous trial.
METHODS


This is a secondary analysis of an investigator-initiated, prospective randomised controlled multicenter trial in Switzerland (EFFORT) that compared the effects of an individualised nutritional support intervention with standard of care. We investigated associations between admission NRS and several short-term and long-term outcomes using multivariable regression analyses.
RESULTS


Of the 2028 patients, 31% had an NRS of 3, 38% of 4 and 31% of ≥5 points, and 477 (24%) died during the 180 days of follow-up. For each point increase in NRS, we found a stepwise increase in risk of 30-day mortality (adjusted Hazard Ratio (HR) 1.22 (95% CI 1.00 to 1.48), p = 0.048) and 180-day mortality (adjusted HR 1.37 (95% CI 1.22 to 1.55), p < 0.001). NRS was associated with length of hospital stay (adjusted difference of 0.60 days per NRS point increase, 95%CI 0.23 to 0.97, p = 0.002) and functional outcomes at 180 days (adjusted decrease in Barthel index of -4.49 points per NRS point increase, 95%CI -6.54 to -2.45, p < 0.001). In a subgroup analysis, associations of NRS and short-term adverse outcomes were less pronounced in patients receiving nutritional support (intervention group) compared to control group patients (adjusted HR for 30-day mortality 1.12 [95%CI 0.83 to 1.52, p = 0.454] vs. 1.33 [95%CI 1.02 to 1.72, p = 0.032]).
CONCLUSION


The NRS is a strong and independent risk score for malnutrition-associated mortality and adverse outcomes over 180 days. Our data provide strong evidence that the nutritional risk, however, is modifiable and can be reduced by the provision of adequate nutritional support.",2020,"In a subgroup analysis, associations of NRS and short-term adverse outcomes were less pronounced in patients receiving nutritional support (intervention group) compared to control group patients (adjusted HR for 30-day mortality 1.12 [95%CI 0.83 to 1.52, p = 0.454] vs. 1.33 [95%CI 1.02 to 1.72, p = 0.032]).
","['2028 patients', 'a well-characterised cohort of medical inpatients from a previous trial']","['Nutritional risk screening (NRS 2002', 'individualised nutritional support intervention']","['risk of 30-day mortality', 'length of hospital stay', '180-day mortality', 'NRS and short-term adverse outcomes', 'NRS', 'functional outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",2028.0,0.185055,"In a subgroup analysis, associations of NRS and short-term adverse outcomes were less pronounced in patients receiving nutritional support (intervention group) compared to control group patients (adjusted HR for 30-day mortality 1.12 [95%CI 0.83 to 1.52, p = 0.454] vs. 1.33 [95%CI 1.02 to 1.72, p = 0.032]).
","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Hersberger', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bargetzi', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Bargetzi', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Internal Medicine, Spital Lachen, Switzerland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Fehr', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Baechli', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Geiser', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Deiss', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; The New York Academy of Sciences, New York City, NY, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kutz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kägi-Braun', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Benz', 'Affiliation': 'Internal Medicine & Endocrinology/Diabetes, Kantonsspital St.Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Nigg', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Internal Medicine, Buergerspital Solothurn, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Brand', 'Affiliation': 'Internal Medicine, Buergerspital Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': ""Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Division of General Internal Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine & Metabolism, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, Division of General Internal and Emergency Medicine, Kantonsspital Aarau, Aarau, Switzerland; Medical Faculty of the University of Basel, Switzerland. Electronic address: schuetzph@gmail.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.11.041']
622,31868978,Gross motor adaptation benefits from sleep after training.,"Sleep has been shown to facilitate the consolidation of newly acquired motor memories. However, the role of sleep in gross motor learning, especially in motor adaptation, is less clear. Thus, we investigated the effects of nocturnal sleep on the performance of a gross motor adaptation task, i.e. riding an inverse steering bicycle. Twenty-six male participants (M = 24.19, SD = 3.70 years) were randomly assigned to a PM-AM-PM (n = 13) or an AM-PM-AM (n = 13) group, i.e. they trained in the evening/morning and were re-tested the next morning/evening and the following evening/morning (PM-AM-PM/AM-PM-AM group) so that every participant spent one sleep as well as one wake interval between the three test sessions. Inverse cycling performance was assessed by speed (riding time) and accuracy (standard deviation of steering angle) measures. Behavioural results showed that in the PM-AM-PM group a night of sleep right after training stabilized performance (accuracy and speed) and was further improved over the subsequent wake interval. In the AM-PM-AM group, a significant performance deterioration after the initial wake interval was followed by the restoration of subjects' performance levels from right after training when a full night of sleep was granted. Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"". Our results demonstrate that sleep facilitates the consolidation of gross motor adaptation, thus adding further insights to the role of sleep for tasks with real-life relevance.",2020,"Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"".","['3.70\xa0years', 'Twenty-six male participants (M\xa0=\xa024.19, SD\xa0']",['PM-AM-PM (n\xa0=\xa013) or an AM-PM-AM'],"['Inverse cycling performance', 'speed (riding time) and accuracy (standard deviation of steering angle) measures']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0553654', 'cui_str': 'Does steer (finding)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",26.0,0.0137131,"Regarding sleep, right hemispheric fast N2 sleep spindle activity was related to better stabilization of inverse cycling skills, thus possibly reflecting the ongoing process of updating the participants' mental model from ""how to ride a bicycle"" to ""how to ride an inverse steering bicycle"".","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Bothe', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Hirschauer', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Wiesinger', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Janina M', 'Initials': 'JM', 'LastName': 'Edfelder', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Hoedlmoser', 'Affiliation': 'Laboratory for Sleep, Cognition and Consciousness Research, Centre for Cognitive Neuroscience, University of Salzburg, Salzburg, Austria.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Birklbauer', 'Affiliation': 'Department of Sport and Exercise Science, University of Salzburg, Salzburg, Austria.'}]",Journal of sleep research,['10.1111/jsr.12961']
623,31864382,The effect of an educational program for pregnant women to prevent allergic diseases in infants: study protocol for a randomized controlled trial.,"BACKGROUND


Allergic diseases in infants have dramatically increased in developed countries during the past few decades. To date, extensive research has been done on risk factors for allergies in infancy, and preventive measures against them. However, the effect of the primary approach to preventing infantile allergy is still limited. The aim of this trial is to evaluate whether prenatal education interventions, including the latest public research results on allergic diseases, prevent the onset of infant allergies.
METHODS/DESIGN


We designed a randomized controlled, two-arm (standard prenatal education vs our education), parallel-group, assessor-blind trial. A sample of 120 pregnant women will be recruited at Chiba Aiyu-kai Kinen Hospital and allocation is by computer-generated randomization. Pregnant women in the intervention arm participate in the childbirth education program established by the specialist and a pediatric allergy educator. The program was developed based on evidences supporting interventions on primary prevention, which are suggested to be beneficial to infantile allergies in recent studies. The primary objective of the study is to determine whether it is possible to establish effective behaviors for allergy prevention in early infancy in the children of pregnant women who participate in an educational program developed by pediatric allergy specialists. Four months after birth, their behaviors will be compared against those of pregnant women who did not participate in the program.
DISCUSSION


Allergies are common in many individuals worldwide, and can be present from babyhood through the person's lifetime. One of the strong points of this study is that it should provide pregnant women with accumulated information on preventive knowledge against allergy, that can be effective in some cases, and that women can apply a combination of these behaviors before and after pregnancy. The results of our program will be publicized to help change the behaviors of mothers, and, if the program is effective, for preventing allergies in infants, it will be disclosed worldwide as a new preventive strategy for allergy in infants.
TRIAL REGISTRATION


UMIN-CTR, ID: UMIN000034730 Retrospectively registered on 1 December 2018.",2019,Pregnant women in the intervention arm participate in the childbirth education program established by the specialist and a pediatric allergy educator.,"['children of pregnant women who participate in an educational program developed by pediatric allergy specialists', 'pregnant women to prevent allergic diseases in infants', '120 pregnant women will be recruited at Chiba Aiyu-kai Kinen Hospital and allocation is by computer-generated randomization', 'pregnant women', 'Pregnant women in the intervention arm participate in the childbirth education program established by the specialist and a pediatric allergy educator']","['educational program', 'prenatal education interventions']",[],"[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3658257', 'cui_str': 'Childbirth Classes'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1276366', 'cui_str': 'Expectant Parent Classes'}]",[],120.0,0.127636,Pregnant women in the intervention arm participate in the childbirth education program established by the specialist and a pediatric allergy educator.,"[{'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'KOSÉ Corporation Research Laboratories, 48-18 Sakae-cho, Kita-ku, Tokyo, 114-0005, Japan. r-itou@kose.co.jp.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': 'Chiba Aiyu-kai Kinen hospital, 1-1 Niregasaki, Nagareyama-shi, Chiba, 270-0161, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Naru', 'Affiliation': 'KOSÉ Corporation Research Laboratories, 48-18 Sakae-cho, Kita-ku, Tokyo, 114-0005, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Ishitsuka', 'Affiliation': 'KOSÉ Corporation Research Laboratories, 48-18 Sakae-cho, Kita-ku, Tokyo, 114-0005, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakade', 'Affiliation': 'KOSÉ Corporation Research Laboratories, 48-18 Sakae-cho, Kita-ku, Tokyo, 114-0005, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nezu', 'Affiliation': 'Chiba Aiyu-kai Kinen hospital, 1-1 Niregasaki, Nagareyama-shi, Chiba, 270-0161, Japan.'}]",Trials,['10.1186/s13063-019-3797-2']
624,31864383,A disorder-specific group cognitive behavior therapy for social anxiety disorder in adolescents: study protocol for a randomized controlled study.,"BACKGROUND


Social anxiety disorder (SAD) is a common disorder in adolescence associated with extensive distress and long-term impairment. Generic cognitive behavior therapy (CBT) programs for anxiety disorders have shown poorer outcomes for adolescents with SAD than for other anxiety disorders.
AIM


The aim of the present study is to investigate the efficacy of a disorder-specific group cognitive behavior therapy (G-CBT) program for youth SAD, the Cool Kids Anxiety Program - Social Enhanced (CK-E), developed at Macquarie University, Sidney, Australia.
METHODS


The study is a randomized controlled trial comparing CK-E to a generic G-CBT program for anxiety disorders. Approximately 96 adolescents aged 12 to 17 years are included with data points at pre- and post-treatment, and at 3 months and 1 year follow-ups.
DISCUSSION


The current study will provide more information about the efficacy of diagnosis-specific G-CBT treatment for youth SAD.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03986827. Registered on 14 June 2019.",2019,"Generic cognitive behavior therapy (CBT) programs for anxiety disorders have shown poorer outcomes for adolescents with SAD than for other anxiety disorders.
","['adolescents with SAD than for other anxiety disorders', 'youth SAD, the Cool Kids Anxiety Program - Social Enhanced (CK-E), developed at Macquarie University, Sidney, Australia', 'anxiety disorders', 'Approximately 96 adolescents aged 12 to 17\u2009years are included with data points at pre- and post-treatment, and at 3 months and 1 year follow-ups', 'social anxiety disorder in adolescents']","['Generic cognitive behavior therapy (CBT) programs', 'generic G-CBT program', 'specific group cognitive behavior therapy', 'disorder-specific group cognitive behavior therapy (G-CBT']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0349232', 'cui_str': 'Other anxiety disorders'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],96.0,0.0702064,"Generic cognitive behavior therapy (CBT) programs for anxiety disorders have shown poorer outcomes for adolescents with SAD than for other anxiety disorders.
","[{'ForeName': 'Nanna Fensman', 'Initials': 'NF', 'LastName': 'Lassen', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Hougaard', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Kristian Bech', 'Initials': 'KB', 'LastName': 'Arendt', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Thastum', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Aarhus, Denmark. mikael@psy.au.dk.'}]",Trials,['10.1186/s13063-019-3885-3']
625,29562853,Virtual Remediation Versus Methylphenidate to Improve Distractibility in Children With ADHD: A Controlled Randomized Clinical Trial Study.,"Objective:  Virtual environments have been used to assess children with ADHD but have never been tested as therapeutic tools. We tested a new virtual classroom cognitive remediation program to improve symptoms in children with ADHD.  Method:  In this randomized clinical trial, 51 children with ADHD (7-11 years) were assigned to a virtual cognitive remediation group, a methylphenidate group, or a psychotherapy group. All children were evaluated before and after therapy with an ADHD Rating Scale, a Continuous Performance Test (CPT), and a virtual classroom task.  Results:  After therapy by virtual remediation, children exhibited significantly higher numbers of correct hits on the virtual classroom and CPT. These improvements were equivalent to those observed with methylphenidate treatment.  Conclusion:  Our study demonstrates for the first time that a cognitive remediation program delivered in a virtual classroom reduces distractibility in children with ADHD and could replace methylphenidate treatment in specific cases.",2020,"After therapy by virtual remediation, children exhibited significantly higher numbers of correct hits on the virtual classroom and CPT.","['Children With ADHD', '51 children with ADHD (7-11 years', 'children with ADHD']","['Virtual Remediation Versus Methylphenidate', 'virtual cognitive remediation', 'psychotherapy group', 'methylphenidate', 'virtual classroom cognitive remediation program']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],51.0,0.0263178,"After therapy by virtual remediation, children exhibited significantly higher numbers of correct hits on the virtual classroom and CPT.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Bioulac', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}, {'ForeName': 'Jean-Arthur', 'Initials': 'JA', 'LastName': 'Micoulaud-Franchi', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Maire', 'Affiliation': 'University of Bordeaux, INSERM U1219, Bordeaux, France.'}, {'ForeName': 'Manuel P', 'Initials': 'MP', 'LastName': 'Bouvard', 'Affiliation': 'Pôle Universitaire Psychiatrie Enfants et Adolescents, Bordeaux, France.'}, {'ForeName': 'Albert A', 'Initials': 'AA', 'LastName': 'Rizzo', 'Affiliation': 'University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sagaspe', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philip', 'Affiliation': 'University of Bordeaux, SANPSY, Bordeaux, France.'}]",Journal of attention disorders,['10.1177/1087054718759751']
626,31790543,Fenfluramine for Treatment-Resistant Seizures in Patients With Dravet Syndrome Receiving Stiripentol-Inclusive Regimens: A Randomized Clinical Trial.,"Importance


Fenfluramine treatment may reduce monthly convulsive seizure frequency in patients with Dravet syndrome who have poor seizure control with their current stiripentol-containing antiepileptic drug regimens.
Objective


To determine whether fenfluramine reduced monthly convulsive seizure frequency relative to placebo in patients with Dravet syndrome who were taking stiripentol-inclusive regimens.
Design, Setting, and Participants


This double-blind, placebo-controlled, parallel-group randomized clinical trial was conducted in multiple centers. Eligible patients were children aged 2 to 18 years with a confirmed clinical diagnosis of Dravet syndrome who were receiving stable, stiripentol-inclusive antiepileptic drug regimens.
Interventions


Patients with 6 or more convulsive seizures during the 6-week baseline period were randomly assigned to receive fenfluramine, 0.4 mg/kg/d (maximum, 17 mg/d), or a placebo. After titration (3 weeks), patients' assigned dosages were maintained for 12 additional weeks. Caregivers recorded seizures via a daily electronic diary.
Main Outcomes and Measures


The primary efficacy end point was the change in mean monthly convulsive seizure frequency between fenfluramine and placebo during the combined titration and maintenance periods relative to baseline.
Results


A total of 115 eligible patients were identified; of these, 87 patients (mean [SD], age 9.1 [4.8] years; 50 male patients [57%]; mean baseline frequency of seizures, approximately 25 convulsive seizures per month) were enrolled and randomized to fenfluramine, 0.4 mg/kg/d (n = 43) or placebo (n = 44). Patients treated with fenfluramine achieved a 54.0% (95% CI, 35.6%-67.2%; P < .001) greater reduction in mean monthly convulsive seizure frequency than those receiving the placebo. With fenfluramine, 54% of patients demonstrated a clinically meaningful (≥50%) reduction in monthly convulsive seizure frequency vs 5% with placebo (P < .001). The median (range) longest seizure-free interval was 22 (3.0-105.0) days with fenfluramine and 13 (1.0-40.0) days with placebo (P = .004). The most common adverse events were decreased appetite (19 patients taking fenfluramine [44%] vs 5 taking placebo [11%]), fatigue (11 [26%] vs 2 [5%]), diarrhea (10 [23%] vs 3 [7%]), and pyrexia (11 [26%] vs 4 [9%]). Cardiac monitoring demonstrated no clinical or echocardiographic evidence of valvular heart disease or pulmonary arterial hypertension.
Conclusions and Relevance


Fenfluramine demonstrated significant improvements in monthly convulsive seizure frequency in patients with Dravet syndrome whose conditions were insufficiently controlled with stiripentol-inclusive antiepileptic drug regimens. Fenfluramine was generally well tolerated. Fenfluramine may represent a new treatment option for Dravet syndrome.
Trial Registration


ClinicalTrials.gov identifier: NCT02926898.",2020,"Conclusions and Relevance


Fenfluramine demonstrated significant improvements in monthly convulsive seizure frequency in patients with Dravet syndrome whose conditions were insufficiently controlled with stiripentol-inclusive antiepileptic drug regimens.","['patients with Dravet syndrome who were taking stiripentol-inclusive regimens', 'Patients With Dravet Syndrome', '115 eligible patients were identified; of these, 87 patients (mean [SD], age 9.1 [4.8] years; 50 male patients [57%]; mean baseline frequency of seizures, approximately 25 convulsive seizures per month', 'patients with Dravet syndrome', 'patients with Dravet syndrome who have poor seizure control with their current stiripentol-containing antiepileptic drug regimens', 'Interventions\n\n\nPatients with 6 or more convulsive seizures during the 6-week baseline period', 'Eligible patients were children aged 2 to 18 years with a confirmed clinical diagnosis of Dravet syndrome who were receiving stable, stiripentol-inclusive antiepileptic drug regimens']","['placebo', 'fenfluramine and placebo', 'Fenfluramine', 'fenfluramine']","['mean monthly convulsive seizure frequency', 'tolerated', 'seizures via a daily electronic diary', 'pyrexia', 'monthly convulsive seizure frequency', 'median (range) longest seizure-free interval', 'diarrhea', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751122', 'cui_str': 'Myoclonic Epilepsy, Severe, Of Infancy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015827', 'cui_str': 'Fenfluramine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",115.0,0.719699,"Conclusions and Relevance


Fenfluramine demonstrated significant improvements in monthly convulsive seizure frequency in patients with Dravet syndrome whose conditions were insufficiently controlled with stiripentol-inclusive antiepileptic drug regimens.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Nabbout', 'Affiliation': 'Hôpital Universitaire Necker-Enfants Malades, Service de Neurologie Pédiatrique Centre de Référence Épilepsies Rares, Imagine Institute, Institut National de la Santé et de la Recherche Médicale, Unite Mixté de Recherche 1163, Paris Descartes University, Paris, France.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Mistry', 'Affiliation': 'Zogenix, Inc, Emeryville, California.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Zuberi', 'Affiliation': 'Paediatric Neurosciences Research Group, Royal Hospital for Children Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Villeneuve', 'Affiliation': 'Assistance Publique-Hôpitaux de Marseille, Department of Pediatric Neurology, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Nagel', 'Affiliation': 'Hospital Ruber Internacional, Madrid, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sanchez-Carpintero', 'Affiliation': 'Pediatric Neurology Unit, Clínica Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stephani', 'Affiliation': 'Department of Neuropediatrics, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Laux', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Wirrell', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Knupp', 'Affiliation': ""University of Colorado, Children's Hospital Colorado, Aurora.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chiron', 'Affiliation': 'Pediatric Neurology, Necker-Enfants Malades Hospital, Institut National de la Santé et de la Recherche Médicale Unite 1141, Paris, France.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Farfel', 'Affiliation': 'Zogenix, Inc, Emeryville, California.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Galer', 'Affiliation': 'Zogenix, Inc, Emeryville, California.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'Zogenix, Inc, Emeryville, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lock', 'Affiliation': 'Zogenix, Inc, Emeryville, California.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Zogenix, Inc, Emeryville, California.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Auvin', 'Affiliation': 'Robert Debré University Hospital, Université de Paris, Institut National de la Santé et de la Recherche Médicale Unite 1141, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.4113']
627,31886828,Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial.,"Importance


Staphylococcus aureus is a leading cause of health care-associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to S aureus colonization, a well-established predisposing factor to invasive S aureus disease.
Objective


To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
Design, Setting, and Participants


Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with S aureus-colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018.
Interventions


Parents were assigned to intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n = 117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n = 119) for 5 days.
Main Outcomes and Measures


The primary end point was concordant S aureus colonization by 90 days, defined as neonatal acquisition of an S aureus strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any S aureus strain and neonatal S aureus infections.
Results


Among 236 randomized neonates, 208 were included in the analytic sample (55% male; 76% singleton births; mean birth weight, 1985 g [SD, 958 g]; 76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up. Among 190 neonates included in the analysis, 74 (38.9%) acquired S aureus colonization by 90 days, of which 42 (56.8%) had a strain concordant with a parental baseline strain. In the intervention and placebo groups, 13 of 89 neonates (14.6%) and 29 of 101 neonates (28.7%), respectively, acquired concordant S aureus colonization (risk difference, -14.1% [95% CI, -30.8% to -3.9%]; hazard ratio [HR], 0.43 [95.2% CI, 0.16 to 0.79]). A total of 28 of 89 neonates (31.4%) in the intervention group and 46 of 101 (45.5%) in the control group acquired any S aureus strain (HR, 0.57 [95% CI, 0.31 to 0.88]), and 1 neonate (1.1%) in the intervention group and 1 neonate (1.0%) in the control group developed an S aureus infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo).
Conclusions and Relevance


In this preliminary trial of parents colonized with S aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an S aureus strain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT02223520.",2020,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
","['76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up', '190 neonates included in the analysis, 74 (38.9', 'Neonates (n\u2009=\u2009236) with S aureus-colonized parent(s) were enrolled', ' 208 were included in the analytic sample (55% male', 'Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit', '76% singleton births; mean birth weight, 1985 g [SD, 958 g', 'The study period was November 7, 2014, through December 13, 2018', '236 randomized neonates', 'parents to neonates']","['placebo', 'intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n\u2009=\u2009117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n\u2009=\u2009119) for 5 days', 'intranasal mupirocin and topical chlorhexidine', 'intranasal mupirocin and chlorhexidine-impregnated cloths']","['neonatal acquisition of any S aureus strain and neonatal S aureus infections', 'acquired S aureus colonization', 'neonatal acquisition of an S aureus strain', 'neonatal colonization', 'Skin reactions', 'transmission of S aureus', 'concordant S aureus colonization']","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]",236.0,0.562881,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.
","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Voskertchian', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Khamash', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Ross', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Aucott', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Carroll', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA,['10.1001/jama.2019.20785']
628,32301372,Pain and load progression following an early maximal strength training program in total hip- and knee arthroplasty patients.,"PURPOSE


Total hip arthroplasty (THA) and total knee arthroplasty (TKA) patients significantly increase muscle strength after maximal strength training (MST) initiated soon after surgery. Owing to severe postoperative pain, knee patients are anticipated to be more limited in performing heavy load exercises than hip patients. The aim of the present study was to describe pain and load progression during early MST in THA and TKA patients.
METHODS


Explorative study based on secondary analyses from two randomized controlled trials: 26 THA and 16 TKA patients had their training sessions logged. They trained at 85-90% of their maximal capacity in leg press, and abduction/knee-extension of the operated leg (4 × 5 repetitions) for 8-10 weeks, initiated early postoperatively.
RESULTS


Knee patients experienced significantly more pain than hip patients during the training sessions ( p  < 0.03), however, pain before and after training was not different ( p  > 0.09). All patients significantly increased leg press training load until the last intervention week ( p  < 0.01).
CONCLUSION


This study demonstrates that TKA patients experience more pain than THA patients during training following a MST program but not more than moderate levels during or after training. Pain before and after training is not different. Both groups significantly increased load progression during the intervention. These findings indicate that both THA and TKA patients might perform MST with extensive load progression early after surgery without compromising pain. The studies were registered at ClinicalTrials.gov .",2020,"RESULTS


Knee patients experienced significantly more pain than hip patients during the training sessions ( p  < 0.03), however, pain before and after training was not different ( p  > 0.09).","['total hip- and knee arthroplasty patients', 'Explorative study based on secondary analyses from two randomized controlled trials: 26 THA and 16 TKA patients had their training sessions logged', 'THA and TKA patients', 'Total hip arthroplasty (THA) and total knee arthroplasty ']","['THA and TKA', 'TKA', 'early maximal strength training program']","['muscle strength', 'Pain', 'Pain and load progression', 'leg press training load', 'pain', 'load progression', 'pain and load progression']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0205282,"RESULTS


Knee patients experienced significantly more pain than hip patients during the training sessions ( p  < 0.03), however, pain before and after training was not different ( p  > 0.09).","[{'ForeName': 'Siri B', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'Department of Orthopaedic Surgery, Clinic of Orthopaedics, Rheumatology, and Dermatology, St. Olavs Hospital HF, Trondheim, Norway.'}, {'ForeName': 'Olav A', 'Initials': 'OA', 'LastName': 'Foss', 'Affiliation': 'Department of Orthopaedic Surgery, Clinic of Orthopaedics, Rheumatology, and Dermatology, St. Olavs Hospital HF, Trondheim, Norway.'}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': 'Department of Orthopaedic Surgery, Clinic of Orthopaedics, Rheumatology, and Dermatology, St. Olavs Hospital HF, Trondheim, Norway.'}, {'ForeName': 'Vigdis S', 'Initials': 'VS', 'LastName': 'Husby', 'Affiliation': 'Department of Orthopaedic Surgery, Clinic of Orthopaedics, Rheumatology, and Dermatology, St. Olavs Hospital HF, Trondheim, Norway.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020916392']
629,32145206,Evaluation of Efficacy of Low Intensity Pulsed Ultrasound in Facilitating Mandibular Fracture Healing-A Blinded Randomized Controlled Clinical Trial.,"PURPOSE


The aim of the study was to evaluate the role of low intensity pulsed ultrasound (LIPUS) in improving fracture healing in American Society of Anesthesiologists Class II patients with mandibular fractures.
MATERIALS AND METHODS


A randomized controlled clinical trial of 40 patients with mandibular fractures was conducted. The patients were randomly allocated to the study and control groups, with 20 members each. A standardized surgical protocol was followed to manage the fractures by open reduction and internal fixation. After fixation, the study group received LIPUS stimulation (1.5 MHz, 30 mW/cm 2 ) on postoperative days 4, 8, 14, and 20 for 20 minutes daily; the control group received no LIPUS stimulation. The outcome parameters assessed were postoperative pain, wound healing, teeth mobility, and radiographic and ultrasound fracture healing.
RESULTS


The study variables were analyzed using the independent samples t test or Mann-Whitney U test. The pain score was reduced in the study group on all postoperative days (P < .001). The mean amount of wound healing was better in the study group than in the control group on days 5 and 9 (P < .004 and P < .019, respectively). The mean score for the ultrasound assessment of fracture healing was greater in the study group, with a statistically significant difference.
CONCLUSIONS


LIPUS application reduced postoperative pain and facilitated fracture healing in patients with compromised healing potential.",2020,The pain score was reduced in the study group on all postoperative days (P < .001).,"['American Society of Anesthesiologists Class II patients with mandibular fractures', '40 patients with mandibular fractures', 'patients with compromised healing potential']","['low intensity pulsed ultrasound (LIPUS', 'LIPUS stimulation', 'LIPUS application', 'Low Intensity Pulsed Ultrasound', 'control group received no LIPUS stimulation']","['postoperative pain and facilitated fracture healing', 'mean amount of wound healing', 'pain score', 'postoperative pain, wound healing, teeth mobility, and radiographic and ultrasound fracture healing', 'mean score for the ultrasound assessment of fracture healing']","[{'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C4042796', 'cui_str': 'Low Intensity Pulsed Ultrasound'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0162542', 'cui_str': 'Fracture Healing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0040445', 'cui_str': 'Tooth Mobility'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",40.0,0.0370075,The pain score was reduced in the study group on all postoperative days (P < .001).,"[{'ForeName': 'Aswath', 'Initials': 'A', 'LastName': 'Gopalan', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Elavenil', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'Guruprasad Thulasi', 'Initials': 'GT', 'LastName': 'Doss', 'Affiliation': 'Reader, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Keerthana', 'Initials': 'K', 'LastName': 'Ponvel', 'Affiliation': 'Postgraduate Trainee, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}, {'ForeName': 'Krishnakumar', 'Initials': 'K', 'LastName': 'Raja Vb', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, SRM Dental College and Hospital, Ramapuram Campus, Chennai, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.036']
630,32098609,Dabigatran Treatment of Acute Noncardioembolic Ischemic Stroke.,"Background and Purpose- Patients with transient ischemic attack (TIA) and minor ischemic stroke are at risk for early recurrent cerebral ischemia. Anticoagulants are associated with reduced recurrence but also increased hemorrhagic transformation (HT). The safety of the novel oral anticoagulant dabigatran in acute stroke has not been evaluated. Methods- DATAS II (Dabigatran Treatment of Acute Stroke II) was a phase II prospective, randomized open label, blinded end point trial. Patients with noncardioembolic stroke/transient ischemic attack (National Institutes of Health Stroke Scale score, ≤9; infarct volume, ≤25 mL) were randomized to dabigatran or aspirin. Magnetic resonance imaging was performed before randomization and repeated at day 30. Imaging end points were ascertained centrally by readers blinded to treatment. The primary end point was symptomatic HT within 37 days of randomization. Results- A total of 305 patients, mean age 66.59±13.21 years, were randomized to dabigatran or aspirin a mean of 42.00±17.31 hours after symptom onset. The qualifying event was a transient ischemic attack in 21%, and ischemic stroke in 79% of patients. Median National Institutes of Health Stroke Scale (interquartile range) was 1 (0-2), and mean infarct volume 3.2±6.5 mL. No symptomatic HT occurred. Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]). Baseline infarct volume predicted incident HT (odds ratio, 1.07 [95% CI, 1.03-1.12];  P =0.0026). Incident covert infarcts on day 30 imaging occurred in 9/142 (6.3%) of dabigatran-assigned and 14/142 (9.8%) of aspirin-assigned patients (relative risk, 0.62 [95% CI, 0.26, 1.48]). Conclusions- Dabigatran was associated with a risk of HT similar to aspirin in acute minor noncardioembolic ischemic stroke/transient ischemic attack. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02295826.",2020,"Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]).","['Acute Noncardioembolic Ischemic Stroke', 'Patients with noncardioembolic stroke/transient ischemic attack (National Institutes of Health Stroke Scale score, ≤9; infarct volume, ≤25 mL', 'A total of 305 patients, mean age 66.59±13.21 years']","['dabigatran or aspirin', 'Dabigatran', 'aspirin', 'Conclusions- Dabigatran', 'Magnetic resonance imaging']","['ischemic stroke', 'symptomatic HT', 'Asymptomatic petechial HT', 'Median National Institutes of Health Stroke Scale', 'hemorrhagic transformation (HT']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}]",305.0,0.308993,"Asymptomatic petechial HT developed in 11/142 (7.8%) of dabigatran-assigned patients and 5/142 (3.5%) of aspirin-assigned patients (relative risk, 2.301 [95% CI, 0.778-6.802]).","[{'ForeName': 'Ken S', 'Initials': 'KS', 'LastName': 'Butcher', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sheridan', 'Affiliation': ''}, {'ForeName': 'Thalia S', 'Initials': 'TS', 'LastName': 'Field', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Shelagh B', 'Initials': 'SB', 'LastName': 'Coutts', 'Affiliation': 'Department of Clinical Neuroscience, Radiology, and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (S.B.C., M.D.H.).'}, {'ForeName': 'Muzzafar', 'Initials': 'M', 'LastName': 'Siddiqui', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Gioia', 'Affiliation': 'University of Montreal, QC, Canada (L.C.G).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neuroscience, Radiology, and Community Health Sciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, AB, Canada (S.B.C., M.D.H.).'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Klahr', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Leka', 'Initials': 'L', 'LastName': 'Sivakumar', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}, {'ForeName': 'Oscar R', 'Initials': 'OR', 'LastName': 'Benavente', 'Affiliation': 'University of British Columbia, Vancouver, Canada (T.S.F., O.R.B.).'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, ON, Canada (M.S., K.N., J.M., T.S.F., J.M., R.G.H).'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'From the Division of Neurology, University of Alberta, Edmonton, Canada (K.S.B., A.C.K., B.B., L.S., M.S.).'}]",Stroke,['10.1161/STROKEAHA.119.027569']
631,32138631,Single-Dose Intraventricular Nimodipine Microparticles Versus Oral Nimodipine for Aneurysmal Subarachnoid Hemorrhage.,"Background and Purpose- EG-1962 is a sustained release formulation of nimodipine administered via external ventricular drain in patients with aneurysmal subarachnoid hemorrhage. A randomized, open-label, phase 1/2a, dose-escalation study provided impetus for this study to evaluate efficacy and safety of a single intraventricular 600 mg dose of EG-1962 to patients with aneurysmal subarachnoid hemorrhage, compared with standard of care oral nimodipine. Methods- Subjects were World Federation of Neurological Surgeons grades 2-4, modified Fisher grades 2-4 and had an external ventricular drain inserted as part of standard of care. The primary end point was the proportion of subjects with favorable outcome at day 90 after aneurysmal subarachnoid hemorrhage (extended Glasgow outcome scale 6-8). The proportion of subjects with favorable outcome at day 90 on the Montreal cognitive assessment, as well as the incidence of delayed cerebral ischemia and infarction, use of rescue therapy and safety were evaluated. Results- The study was halted by the independent data monitoring board after planned interim analysis of 210 subjects (289 randomized) with day 90 outcome found the study was unlikely to achieve its primary end point. After day 90 follow-up of all subjects, the proportion with favorable outcome on the extended Glasgow outcome scale was 45% (65/144) in the EG-1962 and 42% (62/145) in the placebo group (risk ratio, 1.01 [95% CI, 0.83-1.22],  P =0.95). Consistent with its mechanism of action, EG-1962 significantly reduced vasospasm (50% [69/138] EG-1962 versus 63% [91/144],  P =0.025) and hypotension (7% [9/138] versus 10% [14/144]). Analysis of prespecified subject strata suggested potential efficacy in World Federation of Neurological Surgeons 3-4 subjects (46% [32/69] EG-1962 versus 32% [24/75] placebo, odds ratio, 1.22 [95% CI, 0.94-1.58],  P =0.13). No safety concerns were identified that halted the study or that preclude further development. Conclusions- There was no significant increase in favorable outcome for EG-1962 compared with standard of care in the overall study population. The safety profile was acceptable. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02790632.",2020,There was no significant increase in favorable outcome for EG-1962 compared with standard of care in the overall study population.,"['210 subjects (289 randomized', 'patients with aneurysmal subarachnoid hemorrhage, compared with standard of care oral', 'Aneurysmal Subarachnoid Hemorrhage', 'patients with aneurysmal subarachnoid hemorrhage']","['nimodipine', 'placebo', ' and Purpose', 'EG-1962', 'Nimodipine Microparticles Versus Oral Nimodipine', 'Conclusions']","['efficacy and safety', 'favorable outcome for EG-1962', 'extended Glasgow outcome scale', 'vasospasm', 'delayed cerebral ischemia and infarction, use of rescue therapy and safety', 'proportion of subjects with favorable outcome at day 90 after aneurysmal subarachnoid hemorrhage', 'hypotension']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0085616', 'cui_str': 'Vasospasm (finding)'}, {'cui': 'C0917798', 'cui_str': 'Cerebral Ischemia'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",,0.0583632,There was no significant increase in favorable outcome for EG-1962 compared with standard of care in the overall study population.,"[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Carlson', 'Affiliation': 'From the Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque (A.P.C.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hänggi', 'Affiliation': 'Department of Neurosurgery, Düsseldorf University Hospital, Heinrich-Heine-Universität, Germany (D.H.).'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery and Neurosurgery, Prince of Wales Hospital, The Chinese University of Hong Kong, China (G.K.W.).'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Etminan', 'Affiliation': 'Department of Neurosurgery, Ruprecht-Karls-University Heidelberg, Mannheim, Germany (N.E.).'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Mayer', 'Affiliation': 'Department of Neurology, Henry Ford Health System, Detroit, MI (S.A.M.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Aldrich', 'Affiliation': 'Department of Neurosurgery, University of Maryland (F.A.).'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Diringer', 'Affiliation': 'Neurological Critical Care, Washington University School of Medicine, St Louis, MO (M.N.D.).'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Schmutzhard', 'Affiliation': 'Department of Neurology, Neurointensive Care Unit, Medical University Innsbruck, Austria (E.S.).'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Faleck', 'Affiliation': 'Edge Therapeutics, Berkeley Heights, NJ (H.J.F., R.L.M.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ng', 'Affiliation': 'WuXi Clinical, Austin, TX (D.N.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants LLC, Austin, TX (B.R.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bleck', 'Affiliation': 'Department of Neurology, Northwestern University, Feinberg School of Medicine, Chicago, IL (T.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grubb', 'Affiliation': 'Department of Neurological Surgery, Washington University Medical Center, St Louis, MO (R.G.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Integrated Medical Development, Princeton Junction, NJ (M.M.).'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD (J.I.S.).'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin & Associates, Rochester, New York, NY (H.M.P.).'}, {'ForeName': 'R Loch', 'Initials': 'RL', 'LastName': 'Macdonald', 'Affiliation': 'Edge Therapeutics, Berkeley Heights, NJ (H.J.F., R.L.M.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027396']
632,31055640,Low-dose preoperative pregabalin improves postoperative pain management in septorhinoplasty surgery: a double-blind randomized clinical trial.,"PURPOSE


To evaluate the efficacy of single low dose (75 mg) preoperative pregabalin in reducing post-operative pain of septorhinoplasty.
METHODS


A double blind single center Randomized controlled trial based on block randomization. In the pregabalin group (PG) 34 participants received 75 mg pregabalin orally one hour before anesthesia induction while in control group (CG) 34 participants received a placebo. Pain and sedation were repeatedly measured with Visual Analouge Scale (VAS) and Riker Sedation-Agitation Scale (RSAS) respectively, 0.5, 1, 2, 6, 24 hours postextubation. Cumulative doses of fentanyl and ibuprofen received in both groups were compared.
RESULTS


Thirty-two of the participants in PG and 33 of the participants in CG completed the study. The Mean VAS pain score was less in PG versus CG 30 min postoperatively (2.30 ± 1.30 vs. 4.85 ± 1.17), one hour (2.28 ± 0.92 vs. 4.27 ± 0.78), two hours (2.11 ± 0.88 vs. 3.60 ± 0.61) and six hours (1.47 0.62 vs. 2.76 ± 0.91) but not 24-hours postoperatively (0.84 ± 0.62 vs. 1.09 ± 0.92). Participants in the PG were less agitated during early post-extubation period (at 10 min: RSAS 3.93 ± 0.43 vs. 4.42 ± 0.50) and more alert during the first hour post-extubation (at 60 min: RSAS 3.90 ± 0.29 vs. 3.36 ± 0.69). The total dose of rescue fentanyl and ibuprofen was lower in the PG compared to the CG.
CONCLUSIONS


A single dose of 75 mg pregabalin is very effective for pain control after septorhinoplasty procedure when administered one hour before anesthesia induction. Side effects are rare and opioid sparing was noted.
TRIAL REGISTRATION


Clinical trial number: IRCT2017043033706N1.",2019,A single dose of 75 mg pregabalin is very effective for pain control after septorhinoplasty procedure when administered one hour before anesthesia induction.,['septorhinoplasty surgery'],"['single low\xa0dose (75\xa0mg) preoperative pregabalin', 'ibuprofen', 'placebo', 'pregabalin', 'Low-dose preoperative pregabalin']","['Visual Analouge Scale (VAS)\xa0and Riker Sedation-Agitation Scale (RSAS', 'Mean VAS\xa0pain score', 'Pain and sedation', 'postoperative pain management', 'pain control']","[{'cui': 'C0189054', 'cui_str': 'Rhinoseptoplasty (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}]",,0.430834,A single dose of 75 mg pregabalin is very effective for pain control after septorhinoplasty procedure when administered one hour before anesthesia induction.,"[{'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Pourfakhr', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khajavi', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. a.jalali.md@gmail.com.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Memari', 'Affiliation': 'Department of Otology/Neurotology, Erfan Hospital, Tehran, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Etezadi', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrnoush', 'Initials': 'M', 'LastName': 'Momeni Roochi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Shariat Moharari', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atabak', 'Initials': 'A', 'LastName': 'Najafi', 'Affiliation': 'Department of Anesthesiology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05448-y']
633,31241003,The Effect of Framed Health Messages on Intention to Take Antivirals for Pandemic Influenza: A Vignette-Based Randomised Controlled Trial.,"During the last influenza pandemic, adherence to antivirals was suboptimal. This study investigated the effect of manipulating the wording of written health messages on intentions to use antivirals as prophylaxis for pandemic influenza. After reading a hypothetical pandemic flu scenario, adult UK residents (N = 216) were randomly allocated to one of the four conditions, defined by a 2 × 2 (agency assignment × attribute framing) factorial design. Each condition presented messages describing the pandemic flu using linguistic expressions that assigned agency to either humans (HA: human agency) or the virus itself (VA: virus agency), whilst describing the antivirals side effects in terms of the chances of either experiencing (NF: negative framing) or not experiencing side effects (PF: positive framing). Intentions to use the antivirals and potential mediating factors were measured. Mean adherence intentions were high in all conditions with no significant differences between them. Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs were found to predict adherence intentions. The VA messages increased perceived severity, the PF messages increased self-efficacy, whilst VA*PF affected response efficacy. The evidence did not support the hypothesis that the VA and PF framings can increase adherence intentions compared to the HA and NF messages, respectively.",2019,"Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs were found to predict adherence intentions.",['adult UK residents (N = 216'],['Framed Health Messages'],"['self-efficacy, whilst VA*PF affected response efficacy', 'adherence intentions', 'Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs', 'Mean adherence intentions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",216.0,0.0498844,"Higher perceived susceptibility, anticipated regret, self-efficacy, trust, and low response costs were found to predict adherence intentions.","[{'ForeName': 'Donatella', 'Initials': 'D', 'LastName': ""D'Antoni"", 'Affiliation': ""a King's College London, Institute of Pharmaceutical Sciences , London , UK.""}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Auyeung', 'Affiliation': ""a King's College London, Institute of Pharmaceutical Sciences , London , UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weinman', 'Affiliation': ""a King's College London, Institute of Pharmaceutical Sciences , London , UK.""}]",Journal of health communication,['10.1080/10810730.2019.1631914']
634,31127413,Compare two surgical interventions for otitis media with effusion in young children.,"OBJECTIVE


To prospectively evaluate the effect of tympanostomy tubes combined with adenoidectomy and tube insertion on treatment for otitis media with effusion in young children, and to analyze the related factors of prognosis and recurrence of the disease.
METHODS


The clinical and follow-up data of 184 children with otitis media with effusion who were treated in the department of Otolaryngology, Head and Neck Surgery, Beijing Children's Hospital, Capital Medical University from September 2013 to January 2015, were reviewed systematically. According to different surgical methods, they were randomly divided into the observation group in which patients were treated with tube insertion combined with adenoidectomy, and control group in which the rest underwent simple tube insertion. The curative effect, changes of air conduction hearing threshold before and after surgery, the healing time of tympanic membrane and recurrence of middle ear effusion were compared between the two groups. Influencing factors of recurrence of otitis media with effusion were analyzed, and the effect of healing time on tympanic membrane after tube removal was observed.
RESULTS


The total effective rate of treatment in the observation group was higher than that in the control group (91.84% vs 80.23%, P < 0.05), and the air conduction hearing thresholds in two groups were decreased significantly at 3 months and 6 months after surgery, respectively (P < 0.05). The total effective rate of children under 4 years old in the observation group was also higher than that in the control group. The duration of middle ear effusion and the recurrence rate in the observation group were shorter/lower than those in the control group (P < 0.05). Analysis showed that recurrent respiratory tract infection before surgery and retention time of ventilating tube shorter than 12 months were risk factors for recurrence of otitis media with effusion, while adenoidectomy was a protective factor. Besides, the tympanic membrane healing time of the tympanic membrane tube for 1 years was shorter than that of the tympanic membrane tube for more than one year (P < 0.05). The persisted perforation rate is 3.57% in less 12 months of tube, as opposed to it was 12% in more 12 months of tube (P < 0.05).
CONCLUSIONS


Tube insertion combined with adenoidectomy is more effective than tympanostomy tubes in the treatment of young children with OME, and the same results were found for children under four years of age. It can significantly shorten the duration of middle ear effusion and reduce the recurrence rate after surgery. For 3-6 year-old children, the upper respiratory tract infection and short ventilation tube indwelling time increase the possibility of OME recurrence, it is recommended that the ventilation tube should be retained for at least 12 months.",2019,The duration of middle ear effusion and the recurrence rate in the observation group were shorter/lower than those in the control group (P < 0.05).,"['otitis media with effusion in young children', 'young children with OME', ""184 children with otitis media with effusion who were treated in the department of Otolaryngology, Head and Neck Surgery, Beijing Children's Hospital, Capital Medical University from September 2013 to January 2015, were reviewed systematically""]","['tube insertion combined with adenoidectomy, and control group in which the rest underwent simple tube insertion', 'tympanostomy tubes combined with adenoidectomy and tube insertion', 'Tube insertion combined with adenoidectomy']","['duration of middle ear effusion', 'healing time of tympanic membrane and recurrence of middle ear effusion', 'tympanic membrane healing time of the tympanic membrane tube', 'duration of middle ear effusion and the recurrence rate', 'recurrence of otitis media with effusion', 'air conduction hearing thresholds', 'total effective rate', 'perforation rate', 'recurrence rate']","[{'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0041445', 'cui_str': 'Eardrum'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0234744', 'cui_str': 'Air conduction, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}]",184.0,0.0255313,The duration of middle ear effusion and the recurrence rate in the observation group were shorter/lower than those in the control group (P < 0.05).,"[{'ForeName': 'Jinsheng', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Qiaoyin', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China. nixin@bch.com.cn.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""National Center for children's Health, Beijing, People's Republic of China. stzhangj@263.net.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05421-9']
635,32409485,Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.,"OBJECTIVE


To evaluate the efficacy and safety of adjunctive cenobamate 200 mg/d in patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs.
METHODS


In this multicenter, double-blind, placebo-controlled study, adults 18 to 65 years of age with focal seizures were randomized 1:1 (cenobamate:placebo) after an 8-week baseline period. The 12-week double-blind treatment period consisted of a 6-week titration phase and a 6-week maintenance phase. The primary outcome was percent change in seizure frequency (from baseline) per 28 days during double-blind treatment.
RESULTS


Two hundred twenty-two patients were randomized; 113 received cenobamate and 109 received placebo; and 90.3% and 90.8% of patients, respectively, completed double-blind treatment. Median baseline seizure frequency was 6.5 in 28 days (range 0-237). Compared to placebo, cenobamate conferred a greater median percent seizure reduction (55.6% vs 21.5%;  p  < 0.0001) The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p  < 0.0001). Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures were significantly reduced with cenobamate vs placebo. During maintenance, 28.3% of cenobamate-treated and 8.8% of placebo-treated patients were seizure-free. Treatment-emergent adverse events reported in >10% in either group (cenobamate vs placebo) were somnolence (22.1% vs 11.9%), dizziness (22.1% vs 16.5%), headache (12.4% vs 12.8%), nausea (11.5% vs 4.6%), and fatigue (10.6% vs 6.4%).
CONCLUSION


Adjunctive treatment with cenobamate 200 mg/d significantly improved seizure control in adults with uncontrolled focal seizures and was well tolerated.
CLINICALTRIALSGOV IDENTIFIER


NCT01397968.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that, for patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures.",2020,The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p  < 0.0001).,"['patients with uncontrolled focal seizures', 'adults 18 to 65 years of age with focal seizures', 'Two hundred twenty-two patients were randomized; 113 received', 'patients with uncontrolled focal (partial-onset) seizures despite treatment with 1 to 3 antiepileptic drugs', 'patients with uncontrolled focal seizures, adjunctive cenobamate reduces seizures']","['adjunctive cenobamate', 'cenobamate vs placebo', 'cenobamate', 'placebo']","['headache', 'Median baseline seizure frequency', 'dizziness', 'responder rate', 'fatigue', 'seizure-free', 'efficacy and safety', 'somnolence', 'Focal seizures with motor component, impaired awareness, and focal to bilateral tonic-clonic seizures', 'nausea', 'percent change in seizure frequency', 'median percent seizure reduction', 'seizure control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",222.0,0.791106,The responder rate (≥50% reduction in seizure frequency) was 50.4% for cenobamate and 22.2% for placebo ( p  < 0.0001).,"[{'ForeName': 'Steve S', 'Initials': 'SS', 'LastName': 'Chung', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ. steve.chung@bannerhealth.com.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'French', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Kowalski', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Maciejowski', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Rosenfeld', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sperling', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mizne', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'From the Neuroscience Institute (S.S.C), Banner-University Medical Center, University of Arizona, Phoenix; NYU Langone Comprehensive Epilepsy Center (J.A.F.), New York; NZOZ Vito-Med (J.K.), Gliwice, Poland; Johns Hopkins University School of Medicine (G.L.K.), Baltimore, MD; Adult Comprehensive Epilepsy Center (S.K.L.), Seoul National University Hospital, Republic of Korea; NZOZ Diagnomed Clinical Research (M.M.), Katowice, Poland; Comprehensive Epilepsy Care Center for Children and Adults (W.E.R.), St. Louis, MO; Thomas Jefferson University (M.R.S.), Philadelphia, PA; MedVal Scientific Information Services (S.M.), Princeton, NJ; and SK Life Science, Inc (M.K.), Paramus, NJ.'}]",Neurology,['10.1212/WNL.0000000000009530']
636,31839432,"Normal BMI predicts the survival benefits of inductive docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced oral squamous cell carcinoma.","BACKGROUND & AIMS


This study aimed to evaluate the prognostic value of the body mass index (BMI), as well as the association with docetaxel, cisplatin, and 5-fluorouracil (TPF) induction chemotherapy in patients with locally advanced oral squamous cell carcinoma (OSCC).
METHODS


This retrospective study enrolled 253 patients with locally advanced OSCC between 2008 and 2010 based on our previous prospective, randomized, phase 3 trial (NCT01542931). Univariate and multivariate Cox regression models, and the Kaplan-Meier method were used for survival analyses.
RESULTS


Among the 253 patients, the BMI at the time of clinical diagnosis ranged from 13.16 to 34.66 kg/m 2 . Smoking status among patients showed a marked correlation with a higher BMI status at the time of clinical diagnosis (tobacco status: P < 0.001). The distribution of clinical nodal (cN) stage was significantly different, as patients with higher BMIs generally had earlier cN stages (P < 0.021) among the different BMI groups. The Kaplan-Meier analysis showed that the BMI was significantly correlated with overall survival (OS, P = 0.004), disease-free survival (DFS, P = 0.005), locoregional recurrence-free survival (LRFS, P = 0.003) and distant metastasis-free survival (DMFS, P = 0.007). When the BMI was included in the multivariate Cox regression model adjusted for potentially confounding clinical variables, the BMI was shown to be an independent predictive factor of OS (P = 0.015), DFS (P = 0.015), LRFS (P = 0.009), and DMFS (P = 0.023). The TPF group showed better 5-year clinical survival rates than the control group when analyzing patients with a normal BMI (OS: 64.2% vs. 55.9%; DFS: 54.7% vs. 46.4%; LRFS: 56.6% vs. 49.6%; DMFS: 64.2% vs. 56.0%), but no significant difference was observed. Subgroup survival analysis indicated that patients with a normal BMI and clinical stage IVA disease who accepted TPF induction chemotherapy had a significantly improved OS (HR: 0.425, 95% CI: 0.187-0.966, P = 0.035) and DMFS (HR: 0.425, 95% CI: 0.187-0.966, P = 0.034).
CONCLUSION


The BMI at the time of clinical diagnosis was showed to be an independent predictive factor for patients with locally advanced OSCC. Compared with normoweight patients, underweight patients may have worse clinical outcomes, while overweight and obese patients have a better prognosis. A normal BMI in clinical stage IVA OSCC patients predicts significant OS and DMFS benefits of TPF induction chemotherapy.",2020,"The TPF group showed better 5-year clinical survival rates than the control group when analyzing patients with a normal BMI (OS: 64.2% vs. 55.9%; DFS: 54.7% vs. 46.4%; LRFS: 56.6% vs. 49.6%; DMFS: 64.2% vs. 56.0%), but no significant difference was observed.","['253 patients with locally advanced OSCC between 2008 and 2010 based', 'patients with locally advanced OSCC', 'patients with locally advanced oral squamous cell carcinoma (OSCC', 'patients with locally advanced oral squamous cell carcinoma']","['TPF', 'TPF induction chemotherapy', 'inductive docetaxel, cisplatin, and 5-fluorouracil', 'docetaxel, cisplatin, and 5-fluorouracil (TPF) induction chemotherapy']","['BMI status', 'BMI at the time of clinical diagnosis', '5-year clinical survival rates', 'DFS', 'overall survival', 'survival benefits', 'LRFS', 'OS', 'disease-free survival', 'locoregional recurrence-free survival', 'distribution of clinical nodal (cN) stage', 'distant metastasis-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}]","[{'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}]",253.0,0.0490011,"The TPF group showed better 5-year clinical survival rates than the control group when analyzing patients with a normal BMI (OS: 64.2% vs. 55.9%; DFS: 54.7% vs. 46.4%; LRFS: 56.6% vs. 49.6%; DMFS: 64.2% vs. 56.0%), but no significant difference was observed.","[{'ForeName': 'Tong-Chao', 'Initials': 'TC', 'LastName': 'Zhao', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Si-Yuan', 'Initials': 'SY', 'LastName': 'Liang', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Wu-Tong', 'Initials': 'WT', 'LastName': 'Ju', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Yi-Ran', 'Initials': 'YR', 'LastName': 'Tan', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China. Electronic address: tanyiran9th@163.com.""}, {'ForeName': 'Dong-Wang', 'Initials': 'DW', 'LastName': 'Zhu', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Chen-Ping', 'Initials': 'CP', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Zhi-Yuan', 'Initials': 'ZY', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China.""}, {'ForeName': 'Lai-Ping', 'Initials': 'LP', 'LastName': 'Zhong', 'Affiliation': ""Department of Oral & Maxillofacial-Head & Neck Oncology, Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology, National Clinical Research Center for Oral Diseases, Shanghai, China. Electronic address: zhonglp@hotmail.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.11.037']
637,31275125,Does Transcranial Direct Current Stimulation (tDCS) Improve Disgust Regulation Through Imagery Rescripting?,"The first pilot studies have shown the potential of imagery rescripting (ImR) for reducing contamination-related pathological disgust, although the effects were rather small. The aim of the present study is to investigate whether the effects of ImR in reducing disgust can be further increased by transcranial direct current stimulation (tDCS). tDCS is a non-invasive method of brain stimulation that has been successfully used multiple times to support emotion-regulation strategies. In the present study, disgust was induced via images related to individualized sources of disgust. Fifty-eight healthy volunteers took part in two parallel experiments. The two groups were matched by age, highest educational level and gender, and were tested under two emotion-regulation conditions, namely an ImR condition and a control condition. Participants performed three trials on the first day and three trials on the second day. Across both days they performed three trials under each of the two emotion-regulation conditions in a randomized order. On one day active stimulation was applied, while on the other day participants were sham stimulated. The combination of emotion-regulation and stimulation condition was balanced across subjects. The only difference between the two groups was the localization of tDCS stimulation: one group was stimulated over the dorsolateral prefrontal cortex and the other group was stimulated over the visual cortex (VC). This experimental manipulation was implemented to gain further insights into the underlying neuropsychological mechanisms of imagery. ImR was conducted via a previously-recorded audio file. The results confirm the effect of ImR on the reduction of disgust. However, with the present experimental design we were not able to show that supplementary tDCS of the VC or the dorsolateral prefrontal cortex lead to improvement.",2019,"The first pilot studies have shown the potential of imagery rescripting (ImR) for reducing contamination-related pathological disgust, although the effects were rather small.",['Fifty-eight healthy volunteers took part in two parallel experiments'],"['Transcranial Direct Current Stimulation (tDCS', 'tDCS']",['localization of tDCS stimulation'],"[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",58.0,0.0168277,"The first pilot studies have shown the potential of imagery rescripting (ImR) for reducing contamination-related pathological disgust, although the effects were rather small.","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Fink', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Exner', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Leipzig, Leipzig, Germany.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2019.00192']
638,31803482,Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study.,"Objective


Medication adherence is impacted by regimen complexity. The SIMPLE (Simple basal Insulin titration, Metformin Plus Liraglutide for type 2 diabetes with very Elevated HbA1c) study compared GLP1RA plus basal insulin (GLP1RA+BI) to basal-bolus insulin (BBI) regimen in participants with very uncontrolled type 2 diabetes mellitus (T2DM). This analysis aimed to evaluate medication adherence to GLP1RA+BI compared with BBI, the effect of adherence on clinical and patient-reported outcomes, and baseline predictors of adherence.
Research design and methods


This was an analysis of the SIMPLE study based on prespecified outcome. The study took place in pragmatic, real-world setting. A total of 120 adults with T2DM and HgbA1c≥10% were randomized to detemir plus liraglutide, or detemir plus aspart before each meal; 6-month follow-up. The main outcomes evaluated were: adherence, HgbA1c, weight, quality of life, and hypoglycemia. Adherence rate was calculated for each study medication at each follow-up visit; participants were classified as ≥80% or <80% adherent.
Result


A higher percentage of participants in the GLP1RA+BI compared with the BBI group had ≥80% adherence to detemir (59.3% vs 35.7%, p=0.02) as well as liraglutide versus aspart (57.4% vs 30.4%, p=0.007). Higher age was predictive of ≥80% adherence (OR per 5-year increment=1.48, 95% CI 1.09 to 2.0, p=0.01). Higher adherence led to greater improvement in HbA1c and weight in both groups. Treatment with GLP1RA+BI compared with BBI led to greater improvement in HbA1c, weight, and quality of life and lower risk of hypoglycemia even after adjusting for the difference in adherence between groups.
Conclusions


Adherence was higher with the simplified regimen of GLP1RA+BI compared with BBI. Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence.
Trial registration number


NCT01966978.",2019,"Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence.
","['type 2 diabetes', '120 adults with T2DM and HgbA1c≥10', 'participants with very uncontrolled type 2 diabetes mellitus (T2DM']","['medication adherence', 'GLP1RA plus basal insulin (GLP1RA+BI) to basal-bolus insulin', 'GLP1RA+BI', 'detemir plus liraglutide, or detemir plus aspart', 'SIMPLE (Simple basal Insulin titration, Metformin Plus Liraglutide']","['HbA1c and weight', 'Adherence rate', 'adherence, HgbA1c, weight, quality of life, and hypoglycemia', 'HbA1c, weight, and quality of life and lower risk of hypoglycemia', 'HbA1c, weight, quality of life, and risk of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",120.0,0.124561,"Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence.
","[{'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Marconi', 'Initials': 'M', 'LastName': 'Abreu', 'Affiliation': 'Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tumyan', 'Affiliation': 'Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Population and Data Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Population and Data Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Endocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000761']
639,31841156,Exploring Patients' Experiences of Internet-Based Self-Management Support for Low Back Pain in Primary Care.,"OBJECTIVE


We explored patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance.
DESIGN


Exploratory descriptive qualitative study using thematic analysis, nested within a randomized feasibility trial.
METHODS


Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population). Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population). Data were analyzed thematically.
RESULTS


Analysis resulted in the development of six themes (subthemes in parentheses): Perceptions of SupportBack's design (Clarity and ease of use, Variety and range of information provided, Need for specificity and flexibility), Engaging with the SupportBack intervention, Promoting positive thought processes (Reassurance, Awareness of self-management), Managing behavior with SupportBack (Motivation and goal setting, Using activity as a pain management strategy, Preferences for walking or gentle back exercises), Feeling supported by telephone physiotherapists (Provision of reassurances and clarity, Physiotherapists are motivating), Severity and comorbidity as barriers (Preexisting condition or severity acting as a barrier, Less useful for mild low back pain).
CONCLUSIONS


The Internet intervention SupportBack appeared to feasibly support self-management of LBP. Reassurance and ongoing support to implement behavioral changes were central to reported benefits. The addition of physiotherapist telephone support further enhanced the patient experience and the potential utility of the intervention.",2020,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[""patients' experiences of using Internet-based self-management support for low back pain (LBP) in primary care, with and without physiotherapist telephone guidance"", 'Fifteen participants took part (age range = 36-87 years, 66.7% female, characteristics representative of the trial population', 'Patients with LBP who participated in a feasibility trial of the SupportBack Internet intervention (ISRCTN: 31034004) were invited to take part in semistructured telephone interviews after the three-month intervention period (a convenience sample from within the trial population', 'for Low Back Pain in Primary Care']","['Internet-Based Self-Management Support', 'physiotherapist telephone']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],15.0,0.0816618,The Internet intervention SupportBack appeared to feasibly support self-management of LBP.,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Stanford', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Yoganantham', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Arthritis Research UK Primary Care Centre, Institute for Primary Care and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, UK.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz312']
640,30617130,Brentuximab Vedotin plus Chemotherapy in North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma.,"PURPOSE


To evaluate safety and efficacy outcomes for subjects on the ECHELON-1 study treated in North America (NA).
PATIENTS AND METHODS


ECHELON-1 is a global, open-label, randomized phase III study comparing doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD + bleomycin) as first-line therapy in subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490). Subjects were randomized 1:1 to receive A+AVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to 6 cycles.
RESULTS


The NA subgroup consisted of 497 subjects in the A+AVD ( n  = 250) and ABVD ( n  = 247) arms. Similar to the primary analysis based on the intent-to-treat population, the primary endpoint [modified progression-free survival (PFS) per independent review] demonstrated an improvement among subjects who received A+AVD compared with ABVD (HR = 0.60;  P  = 0.012). For PFS, the risk of progression or death was also reduced (HR = 0.50;  P  = 0.002). Subsequent anticancer therapies were lower in the A+AVD arm. Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD. Noted differences between arms included higher rates of febrile neutropenia (20% vs. 9%) and peripheral neuropathy (80% vs. 56%), but lower rates of pulmonary toxicity (3% vs. 10%) in subjects treated with A+AVD versus ABVD.
CONCLUSIONS


The efficacy benefit and manageable toxicity profile observed in the NA subgroup of ECHELON-1 support A+AVD as a frontline treatment option for patients with stage III or IV cHL.",2019,"Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD.","['North American Subjects with Newly Diagnosed Stage III or IV Hodgkin Lymphoma', '497 subjects in the A+AVD ( n  = 250) and ABVD ( n  = 247) arms', 'patients with stage III or IV cHL', 'subjects with stage III or IV classical Hodgkin lymphoma (cHL; NCT01712490', 'subjects on the ECHELON-1 study treated in North America (NA']","['Brentuximab Vedotin plus Chemotherapy', 'A+AVD or ABVD', 'doxorubicin, vinblastine, and dacarbazine in combination with brentuximab vedotin (A+AVD) versus ABVD (AVD + bleomycin']","['progression-free survival (PFS', 'febrile neutropenia', 'efficacy benefit and manageable toxicity profile', 'pulmonary toxicity', 'peripheral neuropathy', 'Grade 3 or 4 adverse events (AEs', 'safety and efficacy outcomes', 'risk of progression or death']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",497.0,0.110861,"Grade 3 or 4 adverse events (AEs) were more common, but there were fewer study discontinuations due to AEs in the A+AVD arm as compared with ABVD.","[{'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Hematology/Oncology, Barbara Ann Karmanos Cancer Center, Detroit, Michigan. RRamchandren@utmck.edu.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, California.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Oncology, Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Centre, Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Friedberg', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Gopal', 'Affiliation': 'Fred Hutchinson Cancer Research Center, University of Washington, Seattle, Washington.'}, {'ForeName': 'Leo I', 'Initials': 'LI', 'LastName': 'Gordon', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kuruvilla', 'Affiliation': 'Division of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'University of British Columbia and the Department of Medical Oncology, British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Engley', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Manley', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'Keenan', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seattle Genetics, Inc., Bothell, Washington.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Straus', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2435']
641,31977572,Easy-to-use tool for evaluating the elevated acute kidney injury risk against reduced cardiovascular disease risk during intensive blood pressure control.,"OBJECTIVE


The Systolic Blood Pressure Intervention Trial (SPRINT) reported that lowering SBP to below 120 mmHg (intensive treatment) reduced cardiovascular morbidity and mortality among adults with hypertension but increased the incidence of adverse events, particularly acute kidney injury (AKI). The goal of this study was to develop an accurate risk estimation tool for comparing the risk of cardiovascular events and adverse kidney-related outcomes between standard and intensive antihypertensive treatment strategies.
METHODS


By applying Lasso regression on the baseline characteristics and health outcomes of 8760 participants with complete baseline information in the SPRINT trial, we developed predictive models for primary cardiovascular disease (CVD) outcome and incidence of AKI. Both models were validated against an independent test set of the SPRINT trial (one third of data not used for model building) and externally against the cardiovascular and renal outcomes available in Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial, consisting of 4733 participants with type 2 diabetes mellitus.
RESULTS


Lasso regression identified a subset of variables that accurately predicted the primary CVD outcome and the incidence of AKI (areas under receiver-operating characteristic curves 0.70 and 0.77, respectively). Based on the validated risk models, an easy-to-use risk assessment tool was developed and made available as an easy-to-use online tool.
CONCLUSION


By predicting the risks of CVD and AKI at baseline, the developed tool can be used to weigh the benefits of intensive versus standard blood pressure control and to identify those who are likely to benefit most from intensive treatment.",2020,", the developed tool can be used to weigh the benefits of intensive versus standard blood pressure control and to identify those who are likely to benefit most from intensive treatment.","['8760 participants with complete baseline information in the SPRINT trial', 'adults with hypertension', '4733 participants with type 2 diabetes mellitus']",[],"['incidence of AKI', 'cardiovascular morbidity and mortality', 'primary cardiovascular disease (CVD) outcome and incidence of AKI']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",8760.0,0.0865745,", the developed tool can be used to weigh the benefits of intensive versus standard blood pressure control and to identify those who are likely to benefit most from intensive treatment.","[{'ForeName': 'Mikko S', 'Initials': 'MS', 'LastName': 'Venäläinen', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Klén', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University.'}, {'ForeName': 'Mehrad', 'Initials': 'M', 'LastName': 'Mahmoudian', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University.'}, {'ForeName': 'Olli T', 'Initials': 'OT', 'LastName': 'Raitakari', 'Affiliation': 'Research Centre of Applied and Preventive Cardiovascular Medicine, University of Turku.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Elo', 'Affiliation': 'Turku Bioscience Centre, University of Turku and Åbo Akademi University.'}]",Journal of hypertension,['10.1097/HJH.0000000000002282']
642,31252161,"Effects of a dawn-dusk simulation on circadian rest-activity cycles, sleep, mood and well-being in dementia patients.","Light is the most powerful ""zeitgeber"" signal to synchronize circadian sleep-wake cycles. In dementia, these rhythms are often fragmented - probably due to loss of neuronal function of the suprachiasmatic nuclei (the biological ""master clock"" in the brain) and/or weakness of external zeitgebers. We investigated the effects of a prototype dawn-dusk simulator (DDS) on circadian rest-activity cycles, sleep, mood and well-being in a balanced crossover design during fall and winter in 20 institutionalized patients with dementia (86 ± 6 y, 17 f). All participants had one baseline week followed by exposure to individually timed DDS over their beds for 7-8 weeks. They spent 8 weeks without DDS as a control. Mood, self-reliant daily activity, social behavior, agitation, and quality of life were assessed by standardized questionnaires and visual analogue scales, regularly rated by trained caregivers. Circadian and sleep characteristics of their rest-activity cycles were analyzed by actimetry over 17 weeks. DDS exposure led to significantly better mood in the morning hours after waking. The effects were most pronounced in the second 4 weeks with DDS, indicating that positive effects emerged gradually. Differences in circadian rest-activity cycles and sleep were mainly age-dependent. We found statistically significant correlations between measures of higher quality of life and better mood, greater alertness and circadian rhythm stability. We conclude that continuous, long-term application of dawn-dusk simulation at the sleep-wake transitions appears to increase external zeitgeber strength in institutionalized patients with dementia. The DDS may provide an effective, non-invasive tool to improve mood and ameliorate patients' quality of life.",2019,"We found statistically significant correlations between measures of higher quality of life and better mood, greater alertness and circadian rhythm stability.","['institutionalized patients with dementia', 'dementia patients', '20 institutionalized patients with dementia (86\u202f±\u202f6 y, 17 f']","['dawn-dusk simulation', 'prototype dawn-dusk simulator (DDS']","['Mood, self-reliant daily activity, social behavior, agitation, and quality of life', 'circadian rest-activity cycles and sleep', 'Circadian and sleep characteristics of their rest-activity cycles', 'higher quality of life and better mood, greater alertness and circadian rhythm stability', 'circadian rest-activity cycles, sleep, mood and well-being', 'external zeitgeber strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0010980', 'cui_str': 'Dapsone'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0037397', 'cui_str': 'Social Behavior'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0001289', 'cui_str': 'Activity Cycles'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]",20.0,0.0901164,"We found statistically significant correlations between measures of higher quality of life and better mood, greater alertness and circadian rhythm stability.","[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Bromundt', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Dept. of Neurology, Inselspital, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wirz-Justice', 'Affiliation': 'Centre for Chronobiology, Transfaculty Research Platform Molecular and Cognitive Neurosciences, Psychiatric Hospital of the University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Boutellier', 'Affiliation': 'Nursing Home Hofmatt, Münchenstein, BL, Switzerland.'}, {'ForeName': 'Seraina', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'Nursing Home Hofmatt, Münchenstein, BL, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Haberstroh', 'Affiliation': 'Haberstroh Architects, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Terman', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Münch', 'Affiliation': 'Charité, University Medicine Berlin, Institute of Physiology and Institute of Medical Immunology, Berlin, Germany. Electronic address: m.munch@massey.ac.nz.'}]",Experimental gerontology,['10.1016/j.exger.2019.110641']
643,31880167,Compassion-focused self-help for psychological distress associated with skin conditions: a randomized feasibility trial.,"Objective:  This study tested the feasibility of a self-help intervention based on Compassion-Focused Theory (CFT), and estimated treatment effects in a population of adults with skin conditions and associated psychological distress. Design:  A randomized-controlled design was used, with 176 participants being allocated to either CFT-based self-help or a waitlist control group, who received usual medical care. The two-week intervention was provided by email. Main Outcome Measures:  Treatment adherence and attrition rates were calculated, and effectiveness was estimated using measures of perceived stress, anxiety, depression, dermatology-specific quality of life and self-compassion. Results:  Eighty-seven participants completed the post-intervention questionnaires (51%), and practiced on a median of 9/14 days. Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls. In intention-to-treat (ITT) analyses, these findings remained significant, however effect sizes reduced from moderate to small. Conclusions:  The findings indicate that CFT self-help shows promise in the treatment of psychological distress associated with skin conditions, however further testing of the intervention is not feasible without significant methodological changes, including the method of treatment delivery. Future studies should also include a follow-up period, as the duration of treatment effects could not be shown.",2020,"Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls.","['population of adults with skin conditions and associated psychological distress', '176 participants being allocated to either']","['Compassion-focused self-help', 'CFT-based self-help or a waitlist control group, who received usual medical care', 'self-help intervention based on Compassion-Focused Theory (CFT']","['post-intervention questionnaires', 'adherence and attrition rates were calculated, and effectiveness was estimated using measures of perceived stress, anxiety, depression, dermatology-specific quality of life and self-compassion', 'measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1719933', 'cui_str': 'Skin condition'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",87.0,0.0307342,"Study completers demonstrated significant, moderate improvements on measures of stress, anxiety, depression, self-compassion and dermatology-specific quality of life, relative to controls.","[{'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Hudson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Emerson', 'Affiliation': 'Department of Psychology, Clinical Psychology Unit, Western Bank, The University of Sheffield, Sheffield, UK.'}]",Psychology & health,['10.1080/08870446.2019.1707829']
644,31282698,Suggestion of cognitive enhancement improves emotion regulation.,"Cognitive training seems a promising approach to enhance emotion regulation. To establish a causal connection, researchers must compare the training intervention with a control group that accounts for improvements induced by some factors other than the training. Despite this familiar methodology, the influence of expectations on the transfer effects of training remains poorly understood. We tested this possibility in 2 experiments, where a procedure was designed to intentionally induce a placebo effect via the suggestion of cognitive enhancement to evaluate the role of expectation in emotion regulation gains from cognitive training. Both the Placebo and Control groups completed the identical short-term working memory training (20 min) in Experiment 1. New participants were recruited to complete a long-term pseudotraining program (7 days) in Experiment 2. The results from the 2 experiments consistently showed that the Placebo group, who expected benefits from the training, unlike the Control group, showed less negative emotion and better regulatory effects after pseudotraining, irrespective of the duration of the training. Thus, inadequate control of expectation is a fundamental design flaw that potentially undermines any causal inferences. These findings also suggest a novel perspective for optimizing the experimental designs in psychological interventions and advancing the understanding of emotion regulation enhancement. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The results from the 2 experiments consistently showed that the Placebo group, who expected benefits from the training, unlike the Control group, showed less negative emotion and better regulatory effects after pseudotraining, irrespective of the duration of the training.",['New participants were recruited to complete a long-term pseudotraining program (7 days) in Experiment 2'],"['Placebo', 'Cognitive training']","['emotion regulation', 'negative emotion and better regulatory effects']","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0259245,"The results from the 2 experiments consistently showed that the Placebo group, who expected benefits from the training, unlike the Control group, showed less negative emotion and better regulatory effects after pseudotraining, irrespective of the duration of the training.","[{'ForeName': 'Quanshan', 'Initials': 'Q', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Hanxiao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Center for Brain Imaging.'}, {'ForeName': 'Jiajin', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}, {'ForeName': 'Antao', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000629']
645,31282704,DUI offenders display reduced perception of intoxication and heightened impulsive choice in response to alcohol.,"Driving under the influence (DUI) of alcohol continues to be a major contributor in traffic fatalities. There is growing evidence for heightened trait impulsivity in DUI offenders, but little is known about how impulsivity could interact with alcohol intoxication in a manner that would increase the likelihood of driving while intoxicated. This placebo-controlled study examined the acute effects of 0.65g/kg alcohol on 2 facets of impulsivity (impulsive choice and response inhibition), simulated risky driving behavior, and subjective intoxication in a group of 20 DUI offenders and 20 control drivers with no history of DUI. It was predicted that compared with controls, DUI offenders would self-report greater impulsivity, and display greater impulsive choice and driver risk taking, particularly in response to alcohol. Results showed that alcohol impaired drivers' inhibitory control and increased their impulsive choice behavior and risky driving behavior. Alcohol selectively increased impulsive choice of DUI offenders, as control drivers showed no alcohol-induced increase in their impulsive choices. Results also showed that, compared with controls, offenders reported feeling less intoxicated and were more willing to drive after drinking. Laboratory studies are beginning to show that DUI offenders differ from nonoffenders in their acute responses to alcohol. This study identified two alcohol response characteristics of DUI offenders that indicate their lack of risk awareness during intoxication: heightened impulsivity and reduced subjective intoxication. Strategies and treatments to alter these response characteristics in DUI offenders could enhance their risk awareness during the intoxicated state and possibly reduce risk of DUI recidivism. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Alcohol selectively increased impulsive choice of DUI offenders, as control drivers showed no alcohol-induced increase in their impulsive choices.","['DUI offenders', '20 DUI offenders and 20 control drivers with no history of DUI']",['placebo'],"['impulsive choice of DUI offenders', 'impulsivity (impulsive choice and response inhibition), simulated risky driving behavior, and subjective intoxication', 'impulsive choice behavior and risky driving behavior']","[{'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]",,0.0175995,"Alcohol selectively increased impulsive choice of DUI offenders, as control drivers showed no alcohol-induced increase in their impulsive choices.","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Fillmore', 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, University of Kentucky.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Van Dyke', 'Affiliation': 'Department of Psychology, University of Kentucky College of Arts and Sciences, University of Kentucky.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000311']
646,31801155,"Meningitis, urinary tract, and bloodstream infections in very low birth weight infants enrolled in a heart rate characteristics monitoring trial.","BACKGROUND


Displaying heart rate characteristic (HRC) scores was associated with lower sepsis-associated mortality in very low birth weight (VLBW) infants in a multicenter randomized controlled trial (HeRO trial). The aim of this study was to test whether HRC indices rise before diagnosis of urinary tract infection (UTI) or meningitis, with and without concomitant BSI.
METHODS


Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants. The HRC index was analyzed 12 h prior to positive cultures compared to 36 h prior, using paired signed-rank tests.
RESULTS


UTI, meningitis, and BSI were diagnosed in 10%, 2%, and 24% of infants, respectively. The mean hourly HRC index was significantly higher 12 h prior to diagnosis of UTI and BSI compared to 36 h prior (UTI 2.07 versus 1.81; BSI 2.62 versus 2.25, both p < 0.0001). The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
CONCLUSIONS


In a large cohort of VLBW infants enrolled in the HeRO trial, the HRC index increased in the 24-h period prior to diagnosis of UTI and BSI but not meningitis.",2020,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","['Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants', 'very low birth weight infants enrolled in a heart rate characteristic monitoring trial']",[],"['HRC index', 'baseline HRC index', 'Meningitis, urinary tract, and bloodstream infections', 'mean hourly HRC index', 'UTI, meningitis, and BSI']","[{'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0042027'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.151055,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","[{'ForeName': 'Joern-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. hendrik.weitkamp@vumc.org.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Aschner', 'Affiliation': 'Pediatrics, Hackensack Meridian Health School of Medicine, Nutley, NJ, USA.'}, {'ForeName': 'Wallly A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bancalari', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Perez', 'Affiliation': 'Pediatrix Medical Group, Orlando, FL, USA.'}, {'ForeName': 'Cristina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whit Walker', 'Affiliation': 'USC School of Medicine, Greenville Memorial Hospital, Greenville, SC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Porcelli', 'Affiliation': 'Pediatrics, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'Pediatrics, Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grossarth', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}]",Pediatric research,['10.1038/s41390-019-0701-4']
647,30836228,ELLIPTA Dry Powder Versus Metered-Dose Inhalers in an Optimized Clinical Trial Setting.,"BACKGROUND


Reduced error rates have been demonstrated with the ELLIPTA inhaler versus other commonly used devices.
OBJECTIVE


This phase IV, randomized, crossover study evaluated correct use of ELLIPTA compared with 2 commonly prescribed metered-dose inhalers (MDIs) in adults with asthma and optimized inhaler technique.
METHODS


The study comprised 2 crossover substudies (ELLIPTA vs MDI-1 and ELLIPTA vs MDI-2). Inhaler use was assessed at the start of each period, following instruction from a health care professional, and after 28 days of use without instruction. Data for each inhaler were pooled within substudies, irrespective of treatment sequence; study objectives were addressed in each substudy. The primary end point, percentage of participants making 0 errors after 28 days of use, was analyzed separately for each substudy using a Mainland-Gart test for each ELLIPTA versus MDI comparison.
RESULTS


Correct use rates after 28 days were higher with ELLIPTA than with MDI-1 and MDI-2 (ELLIPTA vs MDI-1, 96% vs 84%; ELLIPTA vs MDI-2, 98% vs 91%). Among discordant cases, statistically significantly more participants correctly used ELLIPTA but made 1 or more overall error with MDIs than did those who correctly used the MDIs but made 1 or more overall error using ELLIPTA (87% vs 13% in both substudies; P < .001 and P = .007 for ELLIPTA vs MDI-1 and ELLIPTA vs MDI-2, respectively). More participants made multiple device errors with MDIs than with ELLIPTA.
CONCLUSIONS


Inhaler technique can be optimized in trial settings. In such settings, ELLIPTA is associated with higher rates of correct use and lower error rates than are MDIs.",2019,Correct use rates after 28 days were higher with ELLIPTA than with MDI-1,['adults with asthma and optimized inhaler technique'],"['ELLIPTA', 'ELLIPTA Dry Powder Versus Metered-Dose Inhalers', 'MDI-1']","['overall error with MDIs', 'percentage of participants making 0 errors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}]",,0.133948,Correct use rates after 28 days were higher with ELLIPTA than with MDI-1,"[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, Ore. Electronic address: ekerwin@criresearch.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Preece', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline plc., Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Brintziki', 'Affiliation': 'Respiratory Clinical Statistics, GlaxoSmithKline plc., Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Collison', 'Affiliation': 'GlaxoSmithKline plc., Research Triangle Park, Durham, NC.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Respiratory Medical Franchise, GlaxoSmithKline plc., Brentford, Middlesex, United Kingdom.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.02.023']
648,31276178,Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial.,"Importance


Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups.
Objective


To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates.
Design, Setting, and Participants


This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled.
Interventions


Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion).
Main Outcomes and Measures


The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures.
Results


A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03).
Conclusions and Relevance


Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups.
Trial Registration


ClinicalTrials.gov identifier: NCT00697047.",2019,"For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group.","['59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity', 'March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington', '838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled', '838 participants (mean [SD] age']","['colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n\u2009=\u2009270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n\u2009=\u2009284; mailings plus a 1 in 10 chance of receiving $50 on screening completion']","['completion of any colorectal cancer screening', 'Colorectal Cancer Screening Uptake and Decrease Disparities', 'FIT completion', 'Completion of any colorectal screening', 'FIT or colonoscopy completion']","[{'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517801', 'cui_str': '52.2 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0282599', 'cui_str': 'Integrated Health Care Systems'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",838.0,0.172407,"For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group.","[{'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Anderson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Cook', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Chubak', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Fuller', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Kilian J', 'Initials': 'KJ', 'LastName': 'Kimbel', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Kullgren', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Meenan', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Sally W', 'Initials': 'SW', 'LastName': 'Vernon', 'Affiliation': 'Department of Health Promotion and Behavior Sciences, University of Texas School of Public Health, Houston.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.6570']
649,31186189,The relative effects of determinants on Chinese adults' decision for influenza vaccination choice: What is the effect of priming?,"OBJECTIVES


To assess the relative effects of altering different factors (attributes) related to adults' decision for influenza vaccination choice, and whether priming modifies these relative effects.
METHODS


Chinese adults were randomly allocated to either a control condition (non-risk related video), or one of the three health risk-priming conditions (disease (influenza) risk video, intervention (vaccine) risk video, or non-specific (air pollution) risk video), each comprising ∼200 participants, prior to a discrete choice experiment survey. Mixed logit modelling estimated the relative effects of pre-determined attributes influencing vaccination choice.
RESULTS


Across all four conditions, for determining vaccination choice, Vaccine Efficacy had a greater effect than social cues (community vaccination coverage rate (CVCR) and doctors' advice) but social cues can compensate for the effect of ""uncertain"" vaccine safety; influenza case-fatality ratio (CFR) became dominantly important among all included attributes when it reached 20%; vaccination preference increased when a CVCR changed incrementally from 5% to 60% but declined thereafter when the CVCR reached 80%. Compared with Control participants, a CVCR increased by 80% had a smaller effect for participants primed by intervention risk on vaccination choice, while the effect of influenza risk relative to vaccine risk increased following disease risk priming.
CONCLUSION


While increasing confidence on vaccine efficacy is more important for influenza with less severe consequences, highlighting disease consequences becomes increasingly important when its CFR increases, for promoting vaccination uptake. For a new vaccine with uncertain safety, involving doctors and early vaccine takers to validate vaccine safety should be important. Brief exposure to influenza/vaccine risk didn't increase the effect of specific risk on vaccination choice but may change the relative weight of disease versus intervention risk when individuals make trade-off for vaccination decision. Free riding on herd immunity may increase when community vaccination coverage is high particularly following intervention risk priming.",2019,"Across all four conditions, for determining vaccination choice, Vaccine Efficacy had a greater effect than social cues (community vaccination coverage rate (CVCR) and doctors' advice) but social cues can compensate for the effect of ""uncertain"" vaccine safety; influenza case-fatality ratio (CFR) became dominantly important among all included attributes when it reached 20%; vaccination preference increased when a CVCR changed incrementally from 5% to 60% but declined thereafter when the CVCR reached 80%.",['Chinese adults'],"['control condition (non-risk related video), or one of the three health risk-priming conditions (disease (influenza) risk video, intervention (vaccine) risk video, or non-specific (air pollution) risk video']","[""social cues (community vaccination coverage rate (CVCR) and doctors' advice"", 'vaccination preference', 'CVCR']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0001873', 'cui_str': 'Air Pollution'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",,0.0663111,"Across all four conditions, for determining vaccination choice, Vaccine Efficacy had a greater effect than social cues (community vaccination coverage rate (CVCR) and doctors' advice) but social cues can compensate for the effect of ""uncertain"" vaccine safety; influenza case-fatality ratio (CFR) became dominantly important among all included attributes when it reached 20%; vaccination preference increased when a CVCR changed incrementally from 5% to 60% but declined thereafter when the CVCR reached 80%.","[{'ForeName': 'Qiuyan', 'Initials': 'Q', 'LastName': 'Liao', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: qyliao11@hku.hk.'}, {'ForeName': 'Wendy Wing Tak', 'Initials': 'WWT', 'LastName': 'Lam', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: wwtlam@hku.hk.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China. Electronic address: carlosho@hku.hk.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Lam', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: cylam1@hku.hk.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China. Electronic address: pianogal@hku.hk.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fielding', 'Affiliation': 'Division of Behavioural Sciences, School of Public Health, The University of Hong Kong, Hong Kong, China. Electronic address: fielding@hku.hk.'}]",Vaccine,['10.1016/j.vaccine.2019.05.072']
650,32406770,Development of Quality-Controlled Low-Dose Protocols for Radiography in the Neonatal ICU Using a New Mobile Digital Radiography System.,"OBJECTIVE.  The aim of this study was to develop a low-dose radiography protocol for the neonatal ICU (NICU) using a new mobile digital radiography system with advanced denoising image processing and to evaluate the noninferiority of that protocol.  SUBJECTS AND METHODS.  In this prospective randomized study, 40 neonates in the NICU underwent radiography of the thorax and abdomen with two different mobile radiography units: conventional technique on one unit (50 kV, 1.6 mAs, and no additional filtration) and a new technique on another unit (54 kV, 0.1-mm Cu filtration). Three low-dose protocols for the second unit were developed in a phantom study: protocol A (100% equivalent dose with conventional protocol), protocol B (80% equivalent dose), and protocol C (64% equivalent dose). The noninferiority of each low-dose protocol was assessed by three independent readers using image quality criteria.  RESULTS.  Forty patients each underwent three pairs of radiography examinations (protocol A and the conventional protocol, protocol B and the conventional protocol, and protocol C and the conventional protocol), except one pair that did not include one image of the conventional protocol. The interrater reliability among the three readers was 0.91 ( p  < 0.001). Both of the low-dose protocols (B and C) were statistically noninferior to the conventional protocol with respect to overall image quality. Protocol B better depicted almost all anatomic landmarks and had better overall image quality than the conventional protocol.  CONCLUSION.  Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.",2020,"Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.","['40 neonates in the NICU underwent radiography of the thorax and abdomen with two different mobile radiography units: conventional technique on one unit (50 kV, 1.6 mAs, and no additional filtration) and a new technique on another unit (54 kV', 'Forty patients each underwent three pairs of']","['radiography examinations (protocol A and the conventional protocol, protocol B and the conventional protocol, and protocol C and the conventional protocol), except one pair that did not include one image of the conventional protocol']","['overall image quality', 'interrater reliability']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0597311,"Using appropriate technique and acquisition factors, radiation dose can be lowered on a digital radiography system without significant effect on the image quality by adding filtrations and a new denoising technique.","[{'ForeName': 'Gayoung', 'Initials': 'G', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Jung-Eun', 'Initials': 'JE', 'LastName': 'Cheon', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Young Hun', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Seung Han', 'Initials': 'SH', 'LastName': 'Shin', 'Affiliation': 'Department of Pediatrics, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Yeon Jin', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Radiology and Institute of Radiation Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongo-gu, Seoul 03080, Korea.'}, {'ForeName': 'Sun Won', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Seoul National University, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22269']
651,31272939,Temsirolimus versus Pazopanib (TemPa) in Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features: A Randomized Phase II Trial.,"BACKGROUND


Temsirolimus has level 1 evidence for initial treatment of poor-risk patients with advanced renal cell carcinoma (mRCC), but its efficacy has not been directly compared with an antiangiogenic tyrosine kinase inhibitor (vascular endothelial growth factor receptor tyrosine kinase inhibitor [VEGFR TKi]) in this setting.
OBJECTIVE


To evaluate temsirolimus versus pazopanib as first-line therapy in patients with mRCC, predominant clear-cell features, and clinical characteristics of a poor prognosis.
DESIGN, SETTING, AND PARTICIPANTS


A randomized (1:1) phase II trial in 69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center. Crossover to the alternative treatment upon discontinuation of the first-line agent was permitted.
INTERVENTION


Mechanistic target of rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs). Radiographic response was assessed by blinded radiologists. Efficacy outcomes were adjusted by prior nephrectomy status, prior interleukin-2 treatment, and the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score.
RESULTS AND LIMITATIONS


Thirty-five patients received temsirolimus and 34 received pazopanib upfront; 72% overall had poor risk by IMDC. Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210). Median OS was 7.1mo with temsirolimus and 11.9mo with pazopanib (adjusted HR 1.16, 95% CI 0.70-1.93; p=0.558), and ORRs were 5.9% and 21.2%, respectively (adjusted odds ratio 5.2, 95% CI 0.9-29.3; p=0.062). PRO measures favored pazopanib. Five patients discontinued first-line therapy due to adverse events.
CONCLUSIONS


Temsirolimus and pazopanib had modest activity in patients with poor-risk clear-cell mRCC, and therefore their use should be discouraged in this setting.
PATIENT SUMMARY


We evaluated outcomes of advanced renal cell carcinoma patients presenting with aggressive features when treated with temsirolimus or pazopanib as first-line therapy. Survival was <1yr for most, suggesting that more efficacious alternative treatments should be favored for these patients.",2019,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","['patients with mRCC', 'patients with poor-risk clear-cell mRCC', '69 treatment-naïve mRCC patients and with three or more predictors of short survival for temsirolimus was conducted during 2012-2017 in a single academic cancer center', 'Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features', 'advanced renal cell carcinoma patients presenting with aggressive features when treated with', 'poor-risk patients with advanced renal cell carcinoma (mRCC']","['Temsirolimus versus Pazopanib (TemPa', 'Temsirolimus and pazopanib', 'temsirolimus or pazopanib', 'rapamycin inhibitor temsirolimus and VEGFR TKi pazopanib', 'pazopanib', 'pazopanib upfront']","['progression-free survival (PFS', 'Survival', 'Radiographic response', 'overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes (PROs', 'Median OS', 'ORRs', 'International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) score', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0279702', 'cui_str': 'Clear Cell Renal Carcinoma'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",69.0,0.0983514,"Median PFS in the first line was 2.7mo with temsirolimus and 5.2mo with pazopanib (adjusted hazard ratio [HR] 1.36, 95% confidence interval [CI] 0.84-2.22; p=0.210).","[{'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ntannir@mdanderson.org.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Msaouel', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Ross', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Devine', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Graciela M Nogueras', 'Initials': 'GMN', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Corn', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zita D', 'Initials': 'ZD', 'LastName': 'Lim', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Pruitt', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Karam', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Wood', 'Affiliation': 'Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Amado J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",European urology oncology,['10.1016/j.euo.2019.06.004']
652,31209657,Bayesian Population Model of the Pharmacokinetics of Venetoclax in Combination with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results from the Phase III MURANO Study.,"BACKGROUND


Venetoclax is a selective B-cell lymphoma-2 (BCL-2) inhibitor approved for use as monotherapy or with rituximab in patients with chronic lymphocytic leukemia (CLL). The objectives of the current analysis of observed data from adult patients randomized to venetoclax-rituximab in the phase III MURANO study were to characterize venetoclax pharmacokinetics (PKs) using a Bayesian approach, evaluate whether a previously developed population PK model for venetoclax can describe the PKs of venetoclax when administered with rituximab, and to determine post hoc estimates of PK parameters for the exposure-response analysis.
METHODS


Parameter estimates and uncertainty estimated by a population PK model were used as priors. Additional covariate effects (CLL risk status, geographic region, and 17p deletion [del(17p)] status) were added to the model. The updated model was used to describe venetoclax PKs after repeated dosing in combination with rituximab, and to determine post hoc estimates of PK parameters for exposure-response analysis.
RESULTS


The PK analysis included 600 quantifiable venetoclax PK samples from 182 patients in the MURANO study. Model evaluation using standard diagnostic plots, visual predictive checks, and normalized prediction distribution error plots indicated no model deficiencies. There was no significant relationship between venetoclax apparent clearance (CL/F) and bodyweight, age, sex, mild and moderate hepatic and renal impairment, or coadministration of weak cytochrome P450 3A inhibitors. The chromosomal abnormality del(17p) and CLL risk status had no apparent effect on the PKs of venetoclax. A minimal increase in venetoclax CL/F (approximately 7%) was observed after coadministration with rituximab. CL/F was 30% lower in patients from Central and Eastern Europe (n = 60) or Asia (n = 4) compared with other regions (95% confidence interval [CI] 21-39%). Apparent central volume of distribution was 30% lower (95% CI 22-38%) in females (n = 56) compared with males (n = 126). No clinically significant impact of region or sex was observed on key safety and efficacy outcomes.
CONCLUSIONS


The Bayesian model successfully characterized venetoclax PKs over time and confirmed key covariates affecting PKs in the MURANO study. The model was deemed appropriate for further use in simulations and for generating individual patient PK parameters for subsequent exposure-response evaluation.",2019,The model was deemed appropriate for further use in simulations and for generating individual patient PK parameters for subsequent exposure-response evaluation.,"['600 quantifiable venetoclax PK samples from 182 patients in the MURANO study', 'Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia', 'patients with chronic lymphocytic leukemia (CLL']","['venetoclax-rituximab', 'Venetoclax in Combination with Rituximab', 'rituximab']","['venetoclax CL/F', 'venetoclax apparent clearance (CL/F) and bodyweight, age, sex, mild and moderate hepatic and renal impairment', 'Additional covariate effects (CLL risk status, geographic region, and 17p deletion [del(17p)] status', 'key safety and efficacy outcomes', 'Apparent central volume of distribution', 'CL/F']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}]",600.0,0.0410057,The model was deemed appropriate for further use in simulations and for generating individual patient PK parameters for subsequent exposure-response evaluation.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA. deng.rong@gene.com.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm, LLC, North Potomac, MD, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Kshirsagar', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Chunze', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Girish', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Boyer', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Freise', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Ahmed Hamed', 'Initials': 'AH', 'LastName': 'Salem', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital, Peter MacCallum Cancer Centre, and University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Amsterdam UMC, University of Amsterdam on behalf of HOVON CLL WG, Amsterdam, The Netherlands.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00788-8']
653,31240998,The differential influence of computerized neuropsychological assessment across psychopathology.,"Objective:  Novel technologies have transformed neuropsychological test administration so that research examining the equivalency of computerized versions of traditional tests is needed. This study examined the relationship between psychological symptom severity and performance on the Wisconsin Card Sorting Test (WCST) using the manual versus computerized administration. Method:  Eighty-five participants were randomly assigned to the manual or computerized WCST administration and also completed the Dot Counting Test, Depression Anxiety Stress Scales, and Short UPPS-P Impulsive Behavior Scale. Moderation analyses examined the effects of depressive, anxiety, and impulsivity symptom severity on WCST performance. Results:  For Perseverative Responses (PR), the methods of administration (MOAs) were equivalent regardless of psychological symptom severity. For failures to maintain set (FMS), MOA itself influenced performance, with participants making at least twice as many FMS on the computerized WCST. MOA also significantly moderated the relationship between FMS and impulsivity severity, including Lack of Perseverance, Sensation Seeking, and Positive Urgency. Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST. Conclusions:  Findings suggest that equivalence between the manual and computerized versions of the WCST depends on the WCST subscale and the type of psychological symptom. New normative data need to be developed for the computerized WCST, along with a more consistent method of scoring and interpreting WCST subscales.",2020,"Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST.  ",['Method:  Eighty-five participants'],"['manual or computerized WCST', 'Wisconsin Card Sorting Test (WCST) using the manual versus computerized administration']","['depressive, anxiety, and impulsivity symptom severity on WCST performance', 'FMS and impulsivity severity, including Lack of Perseverance, Sensation Seeking, and Positive Urgency', 'Results:  For Perseverative Responses (PR), the methods of administration (MOAs', 'Dot Counting Test, Depression Anxiety Stress Scales, and Short UPPS-P Impulsive Behavior Scale', 'WCST subscale and the type of psychological symptom']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517892', 'cui_str': '85'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",85.0,0.0192767,"Individuals with greater Positive Urgency made more FMS on the manual WCST, and individuals with greater Lack of Perseverance made more FMS on the computerized WCST.  ","[{'ForeName': 'Shifali M', 'Initials': 'SM', 'LastName': 'Singh', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Soble', 'Affiliation': 'Department of Psychiatry, University of Illinois College of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Illinois Institute of Technology, Chicago, IL, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1631888']
654,31789492,"Clinical assessment of tolerability, immunological and cutaneous reactivity effects of an abbreviated schedule with Olea europaeanative extract of subcutaneous immunotherapy.","Summary


Objectives. To evaluate the tolerability and efficacy of Olea europaea subcutaneous immunotherapy (SCIT) on patients with rhinoconjunctivitis. Methods. In this open clinical trial patients were assigned to an abbreviated build-up scheme. The outcomes were: number, percentage, and severity of adverse reactions. Secondary outcomes included: changes in immunoglobulin titers and changes in dose-response skin prick tests. Results. Only 8 systemic reactions were registered, which represented 7/47 (14.9%) of patients and 8/429 (1.9%) of administered doses. Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system. Cutaneous reactivity decreased significantly. Conclusions. Olea europaea SCIT (Allergovac® depot ROXALL Medicina España S.A.) showed a good safety and tolerability profile. Immunological changes with induction of blocking IgG and decreases in cutaneous reactivity were detected in the patients.",2020,Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system.,['patients with rhinoconjunctivitis'],"['subcutaneous immunotherapy', 'Olea europaea subcutaneous immunotherapy (SCIT']","['cutaneous reactivity', 'number, percentage, and severity of adverse reactions', 'sIgG and sIgG4', 'changes in immunoglobulin titers and changes in dose-response skin prick tests', 'Cutaneous reactivity', 'Olea europaea SCIT ', 'tolerability and efficacy', 'tolerability, immunological and cutaneous reactivity effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}]","[{'cui': 'C0413381', 'cui_str': 'Subcutaneous immunotherapy (procedure)'}, {'cui': 'C1122969', 'cui_str': 'Olea europaea'}]","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C1122969', 'cui_str': 'Olea europaea'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0435717,Regarding immunological parameters the significant increases of sIgG and sIgG4 evidenced the changes in the patient immune system.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Saenza De San Pedro', 'Affiliation': 'Hospital Universitario de Jaén. Allergology Department, Jaén, Spain.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Mur', 'Affiliation': 'Hospital Santa Bárbara. Allergology Department, Puertollano, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Valverde', 'Affiliation': 'Hospital Costa de la Luz de Huelva. Allergology Department, Huelva, Spain.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Gonzalo Garijo', 'Affiliation': 'Hospital Universitario Infanta Cristina. Allergology Department, Badajoz, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Hospital Nisa. Allergology Department, Seville, Spain.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Madariaga', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Asturias', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Begona', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gomez Fernandez', 'Affiliation': 'ROXALL España, R and D Department, Zamudio, Spain.'}]",European annals of allergy and clinical immunology,['10.23822/EurAnnACI.1764-1489.124']
655,31683023,Modified Biofeedback (Conditioned Biofeedback) Promotes Antinociception by Increasing the Nociceptive Flexion Reflex Threshold and Reducing Temporal Summation of Pain: A Controlled Trial.,"This study examined whether a modified version of biofeedback (ie, Conditioned Biofeedback) that incorporated placebo analgesia-like manipulations could promote antinociception in healthy, pain-free participants. During Conditioned Biofeedback (n = 28), sympathetic arousal level was displayed visually and participants were asked to reduce it while they received painful electric stimulations that were surreptitiously controlled by their arousal level. Thus, electric pain decreased as arousal decreased to associate successful arousal-reduction/relaxation with pain relief, and to promote expectations for future pain relief. A Biofeedback Only group (n = 24) controlled for the general effects of biofeedback/relaxation. A Biofeedback+Shock group (n = 21) controlled for the effects of practicing biofeedback during painful shocks. Nociceptive flexion reflex (NFR) threshold and temporal summation of pain (TS-pain) were used to assess changes in spinal nociception and pain facilitation, respectively. Results indicated all groups showed pre- to postbiofeedback increases in NFR threshold, but only the Conditioned Biofeedback group showed pre- to postbiofeedback reductions in TS-pain. Moreover, Conditioned Biofeedback resulted in a persistent (prebiofeedback) increase in NFR threshold across sessions, whereas Biofeedback Only resulted in a persistent (prebiofeedback) decrease in TS-pain. In sum, Conditioned Biofeedback may promote antinociception in healthy participants thus reducing risk for chronic pain. The study was registered prospectively on ClinicalTrials.gov (TU1560). PERSPECTIVE: A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers. As a result, it may be an effective means of reducing risk of future chronic pain onset by promoting an antinociceptive pain profile.",2020,A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers.,"['healthy, pain-free participants', 'healthy participants', 'healthy volunteers']","['placebo analgesia-like manipulations', 'Conditioned Biofeedback', 'practicing biofeedback', 'placebo analgesia manipulations', 'biofeedback/relaxation', 'modified version of biofeedback (ie, Conditioned Biofeedback', 'Biofeedback+Shock', 'Modified biofeedback (Conditioned Biofeedback']","['pain facilitation', 'electric pain', 'spinal nociception and pain facilitation', 'sympathetic arousal level', 'temporal summation of pain', 'TS-pain', 'Nociceptive flexion reflex (NFR) threshold and temporal summation of pain (TS-pain', 'NFR threshold']","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation, function (observable entity)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1264664', 'cui_str': 'Number fraction'}]",,0.0847309,A modified version of biofeedback that employs placebo analgesia manipulations was successful in increasing descending inhibition and reducing pain facilitation in healthy volunteers.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Rhudy', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma. Electronic address: jamie-rhudy@utulsa.edu.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Hellman', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Sturycz', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Tyler A', 'Initials': 'TA', 'LastName': 'Toledo', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma.'}, {'ForeName': 'Shreela', 'Initials': 'S', 'LastName': 'Palit', 'Affiliation': 'Department of Psychology, The University of Tulsa, Tulsa, Oklahoma; Pain Research and Intervention Center of Excellence, University of Florida, Gainesville, Florida.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.006']
656,31794625,Effect of Single-Fraction vs Multifraction Radiotherapy on Ambulatory Status Among Patients With Spinal Canal Compression From Metastatic Cancer: The SCORAD Randomized Clinical Trial.,"Importance


Malignant spinal canal compression, a major complication of metastatic cancer, is managed with radiotherapy to maintain mobility and relieve pain, although there is no standard radiotherapy regimen.
Objective


To evaluate whether single-fraction radiotherapy is noninferior to 5 fractions of radiotherapy.
Design, Setting, and Participants


Multicenter noninferiority randomized clinical trial conducted in 42 UK and 5 Australian radiotherapy centers. Eligible patients (n = 686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area. Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017.
Interventions


Patients were randomized to receive external beam single-fraction 8-Gy radiotherapy (n = 345) or 20 Gy of radiotherapy in 5 fractions over 5 consecutive days (n = 341).
Main Outcomes and Measures


The primary end point was ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power). The noninferiority margin for the difference in ambulatory status was -11%. Secondary end points included ambulatory status at weeks 1, 4, and 12 and overall survival.
Results


Among 686 randomized patients (median [interquartile range] age, 70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point (255 patients died before the 8-week assessment). Ambulatory status grade 1 or 2 at week 8 was achieved by 115 of 166 (69.3%) patients in the single-fraction group vs 128 of 176 (72.7%) in the multifraction group (difference, -3.5% [1-sided 95% CI, -11.5% to ∞]; P value for noninferiority = .06). The difference in ambulatory status grade 1 or 2 in the single-fraction vs multifraction group was -0.4% (63.9% vs 64.3%; [1-sided 95% CI, -6.9 to ∞]; P value for noninferiority = .004) at week 1, -0.7% (66.8% vs 67.6%; [1-sided 95% CI, -8.1 to ∞]; P value for noninferiority = .01) at week 4, and 4.1% (71.8% vs 67.7%; [1-sided 95% CI, -4.6 to ∞]; P value for noninferiority = .002) at week 12. Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02 [95% CI, 0.74-1.41]). Of the 11 other secondary end points that were analyzed, the between-group differences were not statistically significant or did not meet noninferiority criterion.
Conclusions and Relevance


Among patients with malignant metastatic solid tumors and spinal canal compression, a single radiotherapy dose, compared with a multifraction dose delivered over 5 days, did not meet the criterion for noninferiority for the primary outcome (ambulatory at 8 weeks). However, the extent to which the lower bound of the CI overlapped with the noninferiority margin should be considered when interpreting the clinical importance of this finding.
Trial Registration


ISRCTN Identifiers: ISRCTN97555949 and ISRCTN97108008.",2019,"Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02","['Patients With Spinal Canal Compression From Metastatic Cancer', '70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point', '42 UK and 5 Australian radiotherapy centers', 'patients with malignant metastatic solid tumors and spinal canal compression', 'Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017', '686 randomized patients (median [interquartile range] age', 'Eligible patients (n\u2009=\u2009686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area']","['single-fraction radiotherapy', 'external beam single-fraction 8-Gy radiotherapy (n\u2009=\u2009345) or 20 Gy of radiotherapy', 'radiotherapy', 'Single-Fraction vs Multifraction Radiotherapy']","['ambulatory status', 'ambulatory status grade', 'ambulatory status at weeks 1, 4, and 12 and overall survival', 'Ambulatory Status', 'ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power', 'Overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037922', 'cui_str': 'Spinal Canal'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0007458', 'cui_str': 'Cauda Equina'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0222045'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",686.0,0.209207,"Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group (stratified hazard ratio, 1.02","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, United Kingdom.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Hopkins', 'Affiliation': 'Bristol Centre for Haematology and Oncology Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Misra', 'Affiliation': 'The Christie Hospital, Manchester, United Kingdom.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Holt', 'Affiliation': 'Princess Alexandra Hospital, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Rhona', 'Initials': 'R', 'LastName': 'McMenemin', 'Affiliation': 'The Freeman Hospital, Newcastle, United Kingdom.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Dubois', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McKinna', 'Affiliation': 'Royal Sussex County Hospital, Brighton, United Kingdom.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Foran', 'Affiliation': 'Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Krishnaswamy', 'Initials': 'K', 'LastName': 'Madhavan', 'Affiliation': 'Southend University Hospital, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'MacGregor', 'Affiliation': 'Raigmore Hospital, Inverness, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bates', 'Affiliation': 'Southampton General Hospital, Southampton, United Kingdom.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': ""O'Rourke"", 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.'}, {'ForeName': 'Jason F', 'Initials': 'JF', 'LastName': 'Lester', 'Affiliation': 'Velindre Cancer Centre, Cardiff, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sevitt', 'Affiliation': 'Kent Oncology Centre, Maidstone, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Castle Hill Hospital, Hull, United Kingdom.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Brown', 'Affiliation': 'Weston Park Hospital, Sheffield, United Kingdom.'}, {'ForeName': 'Seonaid', 'Initials': 'S', 'LastName': 'Arnott', 'Affiliation': 'Raigmore Hospital, Inverness, United Kingdom.'}, {'ForeName': 'Sharon Shibu', 'Initials': 'SS', 'LastName': 'Thomas', 'Affiliation': 'Southend University Hospital, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Forsyth', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Beare', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Reczko', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hackshaw', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'CRUK & UCL Cancer Trials Centre, London, United Kingdom.'}]",JAMA,['10.1001/jama.2019.17913']
657,31794684,Telemedicine Technologies and Tuberculosis Management: A Randomized Controlled Trial.,"Background:  Since 1990s, directly observed therapy (DOT) has been the standard-of-care for tuberculosis (TB), although it is cumbersome for patients as well as service providers. For raising implementation, an alternative delivery method with good potential is telehealth. The current study assessed the clinical and cost benefit of video directly observed therapy (VDOT), compared with DOT service.  Methods:  This prospective randomized controlled trial randomized adults with bacteriologically confirmed pulmonary TB to the intervention (VDOT) or control (DOT) group. The observation data for DOT and VDOT were updated by observers until the end of treatment or until the study concluded. The primary outcome was the TB treatment result defined by the World Health Organization (WHO) as used in some other studies conducted in North India and England as follows: good (cured and treatment completed), poor (death and failure), relocation, and lost to follow-up and others (refused, adverse reaction, not a TB case). Other secondary measures were treatment adherence, patient satisfaction, time and cost spent on DOT or VDOT.  Results:  On analyzing the results from 405 participants from each study arm, we found very high rates of treatment completion (96.1% with VDOT vs. 94.6% with DOT). The two observed treatment methods had no statistical differences, and all could accomplish their tasks well. Average time per dose observed was 16.5 min (standard deviation [SD] 12.1) for VDOT, while 44.1 min (SD 3.7) for DOT (including travel time),  p  < 0.01. And the cost incurred on VDOT was ￥34.3 (SD 3.8) manmo, which was statistically lower compared with ￥71.6 (SD 49.7) manmo in the DOT group,  p  < 0.01. Most of the patients in both groups believed that observed treatment (VDOT/DOT) helped them not to miss doses (185 [93.0%] vs. 171 [86.7%],  p  = 0.057). Patients in the VDOT group had a better experience compared with those in DOT group. They thought the way was convenient and comfortable (191 [96.0%] vs. 111 [56.6%],  p  < 0.001), would choose the original way if necessary (191 [96.0%] vs. 113 [57.7%],  p  < 0.001), and would recommend the method to other patients (191 [96.0%] vs. 113 [57.7%],  p  < 0.001).  Conclusion:  The study showed that VDOT enabled meaningful direct observation for TB patients through mobile devices, which was highly acceptable to patients and health care providers. It also saved time and is a cost-effective method, enabling the use of the saved money to other much-needed areas for TB.",2020,"The two observed treatment methods had no statistical differences, and all could accomplish their tasks well.",['adults with bacteriologically confirmed pulmonary TB to the intervention (VDOT) or control (DOT) group'],"['VDOT', 'Telemedicine Technologies and Tuberculosis Management', 'video directly observed therapy (VDOT']","['poor (death and failure), relocation, and lost to follow-up and others (refused, adverse reaction', 'treatment adherence, patient satisfaction, time and cost spent on DOT or VDOT', 'cost incurred on VDOT', 'TB treatment result defined by the World Health Organization (WHO']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]",405.0,0.0959519,"The two observed treatment methods had no statistical differences, and all could accomplish their tasks well.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shandong Provincial Chest Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'Department of Respiration, Weihai Chest Hospital, Weihai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shandong Provincial Chest Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Shandong Provincial Chest Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Chunting', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0190']
658,19692147,A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain.,"STUDY OBJECTIVE


We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component).
METHODS


This was a randomized, double-blind, clinical trial of children during the first 3 days after discharge from the emergency department (ED). The primary outcome was failure of the oral study medication, defined as use of the rescue medication. Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction were also assessed.
RESULTS


Three hundred thirty-six children were randomized to treatment, 169 to ibuprofen and 167 to acetaminophen with codeine; 244 patients were analyzed. Both groups used a median of 4 doses (interquartile range 2, 6.5). The proportion of treatment failures for ibuprofen (20.3%) was lower than for acetaminophen with codeine (31.0%), though not statistically significant (difference=10.7%; 95% confidence interval -0.2 to 21.6). The proportion of children who had any function (play, sleep, eating, school) affected by pain when pain was analyzed by day after injury was significantly lower for the ibuprofen group. Significantly more children receiving acetaminophen with codeine reported adverse effects and did not want to use it for future fractures.
CONCLUSION


Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.",2009,"There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes.","['Three hundred thirty-six children', 'children with arm fractures', 'children with uncomplicated arm fractures', 'children during the first 3 days after discharge from the emergency department (ED', 'children with arm fractures by', 'acute pediatric arm fracture pain']","['ibuprofen', 'ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component', 'acetaminophen', 'acetaminophen with codeine', 'Ibuprofen', 'codeine']","['analgesic failure or pain scores', 'pain when pain', 'proportion of treatment failures', 'adverse effects', 'failure of the oral study medication, defined as use of the rescue medication', 'Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction', 'functional outcomes']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0178316', 'cui_str': 'Fracture of upper limb (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162643'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",336.0,0.300277,"There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes.","[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Drendel', 'Affiliation': 'Pediatric Emergency Medicine Division, Medical College of Wisconsin, Milwaukee, WI, USA. adrendel@mcw.edu'}, {'ForeName': 'Marc H', 'Initials': 'MH', 'LastName': 'Gorelick', 'Affiliation': ''}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Weisman', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Lyon', 'Affiliation': ''}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Brousseau', 'Affiliation': ''}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': ''}]",Annals of emergency medicine,['10.1016/j.annemergmed.2009.06.005']
659,31782367,Short-term Effect of Fresh Pomegranate Juice on Serum Cortisol and Thyroxine in Patients with type 2 Diabetes.,"BACKGROUND


The effect of pomegranate juice on type 2 diabetic conditions has been determined in various occasions. However, such an effect on cortisol and thyroxine hormones, which are major controllers of energy metabolism, is not yet revealed.
OBJECTIVES


In this study, we intended to measure the short-term effect of fresh pomegranate juice on serum cortisol and thyroxine in patients with type 2 diabetes.
MATERIALS AND METHODS


This study was a randomized clinical trial in which 89 fasted patients with type 2 diabetes were supplemented with fresh pomegranate juice at a dose of 1.5 mL kg-1. Blood specimens were then collected before and at 1 and 3 hours after juice administration. Serum cortisol and thyroxine were assessed using commercial chemiluminescent-immunoassay kits.
RESULTS


Serum cortisol, but not thyroxine, was significantly (P < 0.0001) lower in patients with type 2 diabetes after ingesting fresh pomegranate juice. In addition, no significant correlation (r2 = 0.00003, P = 0.9569) was observed between cortisol response to fresh pomegranate juice and the level of fasting serum glucose in the recruited patients. Moreover, no significant difference (P = 0.9118) in cortisol response to fresh pomegranate juice was found between recruited males and females.
CONCLUSIONS


In conclusion, fresh pomegranate juice decreased serum cortisol, 1 hour after juice ingestion, but not serum thyroxine 3 hours after juice ingestion, in patients with type 2 diabetes. In addition, cortisol response to fresh pomegranate juice was found not to be affected by patients' gender and the level of fasting serum glucose.",2020,"RESULTS


Serum cortisol, but not thyroxine, was significantly (P &amp;lt; 0.0001) lower in patients with type 2 diabetes after ingesting fresh pomegranate juice.","['patients with type 2 diabetes', '89 patients with type 2 diabetes']",['fresh pomegranate juice'],"['Serum cortisol', 'level of fasting serum glucose', 'cortisol response to fresh pomegranate juice', 'cortisol response', 'Serum cortisol and thyroxine', 'serum cortisol and thyroxine', 'cortisol response to fresh pomegranate juice and the level of fasting serum glucose', 'serum cortisol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}]","[{'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}]",89.0,0.023162,"RESULTS


Serum cortisol, but not thyroxine, was significantly (P &amp;lt; 0.0001) lower in patients with type 2 diabetes after ingesting fresh pomegranate juice.","[{'ForeName': 'Saleem Ali', 'Initials': 'SA', 'LastName': 'Banihani', 'Affiliation': 'Department of Medical Laboratory Sciences, Jordan University of Science and Technology, Irbid 22110, Jordan.'}, {'ForeName': 'Seham M', 'Initials': 'SM', 'LastName': 'Makahleh', 'Affiliation': 'Department of Medical Laboratory Sciences, Jordan University of Science and Technology, Irbid 22110, Jordan.'}, {'ForeName': 'Zeyad J', 'Initials': 'ZJ', 'LastName': 'El-Akawi', 'Affiliation': 'Department of Physiology and Biochemistry, Jordan University of Science and Technology, Irbid 22110, Jordan.'}]",Current molecular medicine,['10.2174/1566524019666191129104153']
660,31361922,"Prolonged Effect of Zoledronic Acid on Bone Mineral Density and Turnover in HIV-Infected Adults on Tenofovir: A Randomized, Open-Label Study.","Zoledronic acid (ZOL) 5 mg annually was more effective than tenofovir disoproxil fumarate (TDF) switching at increasing bone mineral density (BMD) over 24 months in HIV-infected, osteopenic adults. To determine whether the effects of ZOL would persist without further infusions, we compared changes in left hip and spine BMD over 36 months in participants randomized to ZOL 5 mg at baseline and month 12 (and to continue TDF) or to switch TDF (without receiving ZOL). We also compared changes in the plasma bone turnover markers (BTMs) C-terminal telopeptide of type 1 collagen (CTX; bone resorption), and procollagen type 1 N propeptide (P1NP; bone formation) and determined whether CTX and P1NP changes at month 3 predicted BMD changes at month 36. Changes were compared in the per-protocol populations, which included 32 (74%) of 43 participants randomized to ZOL and 37 (88%) of 42 participants who switched TDF. Despite not receiving ZOL after month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at month 36 than with TDF switching (spine: 7.5% versus 2.7%, mean difference 4.7%, p < 0.001; hip: 5.5% versus 1.5%, mean difference 4.0%, p < 0.001). CTX and P1NP levels declined in both groups but significantly more with ZOL. Only percent changes in P1NP at month 3 correlated inversely with BMD changes at month 36 (spine: rho = -0.442, p < 0.001; hip: rho = -0.373, p = 0.002). Two infusions of ZOL (in the presence of ongoing TDF) yielded sustained BMD increases through month 36 that remained greater than with TDF switching. © 2019 American Society for Bone and Mineral Research.",2019,"Despite not receiving ZOL after Month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at Month 36 than with TDF switching (spine: 7.5% vs 2.7%, mean difference 4.7%,",['HIV-infected adults on'],"['tenofovir', 'ZOL', 'switch TDF (without receiving ZOL', 'tenofovir disoproxil fumarate (TDF) switching', 'Zoledronic acid (ZOL', 'zoledronic acid']","['sustained BMD', 'mean hip and spine BMD change', 'CTX and P1NP levels', 'bone mineral density (BMD', 'BMD changes', 'bone mineral density and turnover', 'left hip and spine BMD', 'plasma bone turnover markers (BTMs']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}]",43.0,0.0517675,"Despite not receiving ZOL after Month 12, mean hip and spine BMD change from baseline were stable and remained greater with ZOL at Month 36 than with TDF switching (spine: 7.5% vs 2.7%, mean difference 4.7%,","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': ""Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kerr', 'Affiliation': ""Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Richardson', 'Affiliation': ""Centre for Applied Medical Research, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Pocock', 'Affiliation': ""Department of Nuclear Medicine, St Vincent's Hospital, Sydney, Australia.""}, {'ForeName': 'Jhon', 'Initials': 'J', 'LastName': 'Rojas', 'Affiliation': 'Infectious Diseases Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Infectious Diseases Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hoy', 'Affiliation': 'Department of Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3834']
661,31093929,The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects.,"BACKGROUND


Oral insulin 338 is a novel tablet formulation of a long-acting basal insulin. This randomised, open-label, four-period crossover trial investigated the effect of timing of food intake on the single-dose pharmacokinetic properties of oral insulin 338.
METHODS


After an overnight fast, 44 healthy males received single fixed doses of oral insulin 338 administered 0, 30, 60 or 360 min before consuming a standardised meal (500 kcal, 57 energy percent [E%] carbohydrate, 13 E% fat, 30 E% protein). Blood samples for pharmacokinetic assessment were taken up to 288 h post-dose.
RESULTS


Total exposure (area under the concentration-time curve from time zero to infinity [AUC Ins338,0-∞ ]) and maximum concentration (C max,Ins338 ) of insulin 338 were both significantly lower for 0 versus 360 min post-dose fasting (ratio [95% confidence interval (CI)]: 0.36 [0.26-0.49], p < 0.001, and 0.35 [0.25-0.49], p < 0.001, respectively). There were no significant differences in AUC Ins338,0-∞  and C max,Ins338  for 30 or 60 versus 360 min post-dose fasting (ratio [95% CI] 30 versus 360 min: 0.85 [0.61-1.21], p = 0.36, and 0.86 [0.59-1.26], p = 0.42; ratio [95% CI] 60 versus 360 min: 0.96 [0.72-1.28], p = 0.77, and 0.99 [0.75-1.31], p = 0.95). The mean half-life was ~ 55 h independent of the post-dose fasting period. Oral insulin 338 was well-tolerated with no safety issues identified during the trial.
CONCLUSIONS


Oral insulin 338 pharmacokinetics are not affected by food intake from 30 min after dosing, implying that patients with diabetes mellitus do not need to wait more than 30 min after a morning dose of oral insulin 338 before having their breakfast. This is considered important for convenience and treatment compliance. CLINICALTRIALS.
GOV IDENTIFIER


NCT02304627.",2019,"There were no significant differences in AUC Ins338,0-∞  and C max,Ins338  for 30 or 60 versus 360 ","['Healthy Male Subjects', 'patients with diabetes mellitus', '44 healthy males']","['oral insulin 338 administered 0, 30, 60 or 360\xa0min before consuming a standardised meal', 'Food Intake']","['Total exposure (area under the concentration-time curve', 'mean half-life', 'Pharmacokinetics of Oral Basal Insulin']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",44.0,0.227668,"There were no significant differences in AUC Ins338,0-∞  and C max,Ins338  for 30 or 60 versus 360 ","[{'ForeName': 'Inge B', 'Initials': 'IB', 'LastName': 'Halberg', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. ibh@novonordisk.com.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lyby', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Wassermann', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraße 9, 41460, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil Mainz GmbH & Co. KG, Rheinstraße 4c, 55116, Mainz, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil Institut für Stoffwechselforschung GmbH, Hellersbergstraße 9, 41460, Neuss, Germany.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00772-2']
662,31790546,Effectiveness of a Brief Self-determination Theory-Based Smoking Cessation Intervention for Smokers at Emergency Departments in Hong Kong: A Randomized Clinical Trial.,"Importance


Clinicians have an opportunity to provide smoking cessation interventions to smokers who present to emergency departments (EDs). The effectiveness of a brief intervention based on self-determination theory for smoking cessation is uncertain.
Objective


To examine the effectiveness of a brief intervention based on self-determination theory for smoking cessation (immediate or progressive) among Chinese smokers presenting at EDs in Hong Kong.
Design, Setting, and Participants


This single-blind, multicenter intent-to-treat randomized clinical trial was conducted at the EDs of 4 major acute care hospitals in different districts of Hong Kong. In total, 1571 smokers 18 years or older who presented at 4 major EDs between July 4, 2015, and March 17, 2017, were randomized into an intervention group (n = 787) and a control group (n = 784).
Interventions


The intervention group received brief advice (about 1 minute) and could choose their own quit schedules (immediate or progressive). The control group received a smoking cessation leaflet.
Main Outcomes and Measures


Follow-up visits were conducted at 1, 3, 6, and 12 months. The primary outcome measure, by intent to treat, was biochemically validated abstinence at 6 months.
Results


Participants (N = 1571) included 1381 men (87.9%); the mean (SD) age at baseline was 47.4 (16.4) years. Among participants who self-reported abstinence at 6 months, 50.3% (85 of 169) had biochemical validation by both an exhaled carbon monoxide test and a saliva cotinine test. Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P < .001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P < .001). The intervention group also had higher self-reported quit rates at 6 months (12.2% [96 of 787] vs 9.3% [73 of 784], P = .04) and 12 months (13.0% [102 of 787] vs 8.5% [67 of 784], P < .01), as well as higher biochemically validated abstinence at 12 months (7.0% [55 of 787] vs 3.7% [29 of 784], P < .001). The additional cost for each intervention group participant was US $0.47, with an estimated gain of 0.0238 quality-adjusted life-year. The incremental cost per quality-adjusted life-year (US $19.53) fell within acceptable thresholds.
Conclusions and Relevance


This brief, low-cost self-determination theory-based intervention for smokers presenting at EDs effectively increased the biochemically validated quit rate at 6 months. If delivered routinely, such a simple intervention may offer a cost-effective and sustainable approach to help many smokers quit smoking.
Trial Registration


ClinicalTrials.gov identifier: NCT02660957.",2020,"Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P < .001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P < .001).","['4 major acute care hospitals in different districts of Hong Kong', 'Smokers at Emergency Departments in Hong Kong', '1571 smokers 18 years or older who presented at 4 major EDs between July 4, 2015, and March 17, 2017', 'Results\n\n\nParticipants (N\u2009=\u20091571) included 1381 men (87.9%); the mean (SD) age at baseline was 47.4 (16.4) years', 'Chinese smokers presenting at EDs in Hong Kong']","['brief advice (about 1 minute) and could choose their own quit schedules (immediate or progressive', 'brief intervention based on self-determination theory for smoking cessation (immediate or progressive', 'smoking cessation leaflet', 'Brief Self-determination Theory-Based Smoking Cessation Intervention']","['validated abstinence', 'higher self-reported quit rates', 'exhaled carbon monoxide test and a saliva cotinine test']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}]",1381.0,0.0958918,"Compared with the control group, the intervention group had statistically higher biochemically validated abstinence at 6 months: 6.7% (53 of 787) vs 2.8% (22 of 784) (P < .001), with an adjusted relative risk of 3.21 (95% CI, 1.74-5.93; P < .001).","[{'ForeName': 'William Ho Cheung', 'Initials': 'WHC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ka Yan', 'Initials': 'KY', 'LastName': 'Ho', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Derek Yee Tak', 'Initials': 'DYT', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Katherine Ka Wai', 'Initials': 'KKW', 'LastName': 'Lam', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kai Yeung', 'Initials': 'KY', 'LastName': 'Cheung', 'Affiliation': 'United Christian Hospital, Hospital Authority, Hong Kong, China.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sophia Siu Chee', 'Initials': 'SSC', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5176']
663,30997650,Optimal Sampling Strategies for Therapeutic Drug Monitoring of First-Line Tuberculosis Drugs in Patients with Tuberculosis.,"BACKGROUND


The 24-h area under the concentration-time curve (AUC 24 )/minimal inhibitory concentration ratio is the best predictive pharmacokinetic/pharmacodynamic (PK/PD) parameter of the efficacy of first-line anti-tuberculosis (TB) drugs. An optimal sampling strategy (OSS) is useful for accurately estimating AUC 24 ; however, OSS has not been developed in the fed state or in the early phase of treatment for first-line anti-TB drugs.
METHODS


An OSS for the prediction of AUC 24  of isoniazid, rifampicin, ethambutol and pyrazinamide was developed for TB patients starting treatment. A prospective, randomized, crossover trial was performed during the first 3 days of treatment in which first-line anti-TB drugs were administered either intravenously or in fasting or fed conditions. The PK data were used to develop OSS with best subset selection multiple linear regression. The OSS was internally validated using a jackknife analysis and externally validated with other patients from different ethnicities and in a steady state of treatment.
RESULTS


OSS using time points of 2, 4 and 8 h post-dose performed best. Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition. External validation showed that OSS 2-4-8  cannot be used for rifampicin in steady state conditions.
CONCLUSION


OSS at 2, 4 and 8 h post-dose enabled an accurate and precise prediction of AUC 24  values of first-line anti-TB drugs in this population.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT02121314).",2019,Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition.,['Patients with Tuberculosis'],"['rifampicin', 'isoniazid, rifampicin, ethambutol and pyrazinamide']",['concentration-time curve'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0518982,Bias was < 5% and imprecision was < 15% for all drugs except ethambutol in the fed condition.,"[{'ForeName': 'Antonia Morita I', 'Initials': 'AMI', 'LastName': 'Saktiawati', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Harkema', 'Affiliation': ', Groningen, The Netherlands.'}, {'ForeName': 'Althaf', 'Initials': 'A', 'LastName': 'Setyawan', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Population Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yanri W', 'Initials': 'YW', 'LastName': 'Subronto', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Sumardi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Ymkje', 'Initials': 'Y', 'LastName': 'Stienstra', 'Affiliation': 'Department of Internal Medicine/Infectious Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rob E', 'Initials': 'RE', 'LastName': 'Aarnoutse', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Magis-Escurra', 'Affiliation': 'Department of Pulmonary Diseases, Radboud University Medical Center-Dekkerswald, Groesbeek, The Netherlands.'}, {'ForeName': 'Jos G W', 'Initials': 'JGW', 'LastName': 'Kosterink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Tjip S', 'Initials': 'TS', 'LastName': 'van der Werf', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jan-Willem C', 'Initials': 'JC', 'LastName': 'Alffenaar', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands.'}, {'ForeName': 'Marieke G G', 'Initials': 'MGG', 'LastName': 'Sturkenboom', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, PO Box 30.001, 9700 RB, Groningen, The Netherlands. m.g.g.sturkenboom@umcg.nl.'}]",Clinical pharmacokinetics,['10.1007/s40262-019-00763-3']
664,31790015,A Pilot Study Comparing Effects of Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation in Mild Cognitive Impairment and Mild Alzheimer Disease.,"OBJECTIVE


While transcranial direct current stimulation (tDCS) can enhance aspects of memory in patients with mild cognitive impairment (MCI) and Alzheimer disease (AD), there has been wide variability in both the placement of tDCS electrodes and treatment response. This study compared the effects of bifrontal (anodal stimulation over the dorsolateral prefrontal cortices), bitemporal (anodal stimulation over the temporal cortices), and sham tDCS on cognitive performance in MCI and AD.
METHODS


Seventeen patients diagnosed with MCI or mild AD received 3 sessions of anodal tDCS (bifrontal, bitemporal, 2 mA for 20 minutes; and sham) in random order. Sessions were separated by 1 week. The Alzheimer's Disease Assessment Scale-Cognitive Word Recognition Task, Alzheimer's Disease Assessment Scale-Cognitive Word Recall Task, 2-back, and Montreal Cognitive Assessment were used to assess cognition.
RESULTS


There was a significant effect of stimulation condition on 2-back accuracy (F2,28 = 5.28 P = 0.01, ηp = 0.27), with greater improvements following bitemporal tDCS compared with both bifrontal and sham stimulations. There were no significant changes on other outcome measures following any stimulation. Adverse effects from stimulation were mild and temporary.
CONCLUSIONS


These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.",2020,These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.,"['Mild Cognitive Impairment and Mild Alzheimer Disease', 'Seventeen patients diagnosed with MCI or mild AD', 'patients with mild cognitive impairment (MCI) and Alzheimer disease (AD']","['transcranial direct current stimulation (tDCS', 'Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation', 'bifrontal (anodal stimulation', 'anodal tDCS (bifrontal, bitemporal, 2 mA for 20 minutes; and sham']","['cognitive performance', 'specific memory tasks', ""Alzheimer's Disease Assessment Scale-Cognitive Word Recognition Task, Alzheimer's Disease Assessment Scale-Cognitive Word Recall Task, 2-back, and Montreal Cognitive Assessment"", '2-back accuracy']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal (qualifier value)'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C3496286'}]",,0.145084,These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.,"[{'ForeName': 'Celina S', 'Initials': 'CS', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pharmacology & Toxicology, University of Toronto.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Adult Neurodevelopment and Geriatric Psychiatry Division, Centre for Addiction & Mental Health.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Vieira', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'From the Department of Pharmacology & Toxicology, University of Toronto.'}]",The journal of ECT,['10.1097/YCT.0000000000000639']
665,31155415,Safety and immunogenicity of a replication-deficient H5N1 influenza virus vaccine lacking NS1.,"BACKGROUND


Traditional inactivated influenza vaccines are the type of vaccines that were most frequently developed for immunization against the highly pathogenic avian H5N1 influenza virus. However, clinical trials with inactivated influenza vaccines for H5N1 indicated that high doses and at least two immunizations are required for an effective immune response (Nicholson et al., 2001; Treanor, Campbell et al., 2006; Treanor, Schiff et al., 2006; Ehrlich et al., 2008). We investigated the safety and immunogenicity of a live attenuated H5N1 vaccine (delNS1-H5N1) lacking the interferon antagonist nonstructural protein 1 (NS1).
METHODS


We conducted a double-blind, placebo-controlled, phase 1 study in healthy adult participants who were randomly assigned at a 2:1 ratio to receive two immunizations of delNS1-H5N1 vaccine at 6.8 log10 50% tissue culture infectious doses (TCID 50 )/subject or 7.5 log10 TCID 50 /subject, or placebo.
RESULTS


Intranasal vaccination with the live attenuated delNS1-H5N1 vaccine was safe and well tolerated. The most common adverse events identified were symptoms associated with mild influenza infections, such as increased body temperature (>37.0 °C), pharyngeal erythema, rhinitis and throat irritation, and were reported within 7 days after the first immunization. delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID 50 /subject. Seroconversion occurred in 75% of study participants after only one immunization with 7.5 log10 TCID 50 /subject. Vaccine-specific local IgA responses were observed in 41.7% of individuals that showed serum antibody responses after 2nd immunization.
CONCLUSIONS


We show that vaccination with a live attenuated H5N1 influenza vaccine lacking NS1 is safe and induces significant levels of vaccine-specific antibodies even after one immunization. The safety and immunogenicity data indicate that delNS1-H5N1 has the potential to fulfil the unmet need for an effective influenza vaccine in pandemic situations. (ClinicalTrials.gov identifier NCT03745274).",2019,delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID 50 /subject.,['healthy adult participants'],"['placebo', 'delNS1-H5N1', 'replication-deficient H5N1 influenza virus vaccine lacking NS1', 'delNS1-H5N1 vaccine at 6.8 log10 50% tissue culture infectious doses (TCID 50 )/subject or 7.5 log10', 'delNS1-H5N1 vaccine', 'live attenuated H5N1 vaccine (delNS1-H5N1']","['safe and well tolerated', 'serum antibody responses', 'pharyngeal erythema, rhinitis and throat irritation', 'Seroconversion', 'Vaccine-specific local IgA responses', 'body temperature', 'vaccine-specific serum antibody titers', 'safety and immunogenicity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C2748361', 'cui_str': 'H5N1 influenza'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0040284', 'cui_str': 'Tissue culture (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0455899', 'cui_str': 'Red throat (disorder)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0700184', 'cui_str': 'Throat irritation (finding)'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0784688,delNS1-H5N1 was able to induce significant vaccine-specific serum antibody titers even at the lower dose level of 6.8 log10 TCID 50 /subject.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nicolodi', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria. Electronic address: nicolodi.christina@gmail.com.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Groiss', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Kiselev', 'Affiliation': 'Research Institute of Influenza, Russian Academy of Medical Sciences, St. Petersburg, Russia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Wolschek', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Seipelt', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muster', 'Affiliation': 'AVIR Green Hills Biotechnology, 1200 Vienna, Austria.'}]",Vaccine,['10.1016/j.vaccine.2019.05.013']
666,31153688,The influence of neonatal Bacille Calmette-Guérin (BCG) immunisation on heterologous vaccine responses in infants.,"INTRODUCTION


Bacillus Calmette-Guérin vaccine (BCG), one of the most widely used vaccines, does not only provide protection against tuberculosis and other mycobacterial infections, but also has non-specific (heterologous) immunomodulatory effects. In participants in a randomised trial, we investigated the effect of neonatal BCG immunisation on antibody responses to routine infant vaccines given in the first year of life.
METHODS


Antibodies against antigens in the diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b (Hib), and the 13-valent pneumococcal conjugate vaccines were measured in 91 (45 BCG-vaccinated, 46 BCG-naïve) infants one month after, and in 310 (169 BCG-vaccinated, 141 BCG-naïve) infants seven months after immunisation at 6 weeks, 4 and 6 months of age. In addition, antibodies against meningococcus C, Hib, measles, mumps, and rubella were measured in 147 (78 BCG-vaccinated, 69 BCG-naïve) infants one month after immunisation at 12 months of age. The seroprotection rates for each vaccine and the geometric mean concentrations (GMC) of antibodies were compared in BCG-vaccinated and BCG-naïve infants.
RESULTS


At 7 months of age, seroprotection rates were high in both BCG-vaccinated and BCG-naïve infants. At 13 months of age, seroprotection rates were lower than at 7 months of age, particularly for pertussis and a number of pneumococcal antigens, with generally higher rates for the latter in BCG-vaccinated infants. Although not statistically significant, antibody responses in BCG-vaccinated infants were consistently higher against diphtheria, tetanus, and pneumococcal antigens at both 7 and 13 months of age, and against measles and mumps at 13 months of age, but were lower against Hib one month after immunisation at both 7 and 13 months of age.
CONCLUSION


The immunomodulatory effect of BCG on antibody responses to heterologous vaccines adds to the evidence that BCG immunisation at birth has broad heterologous effects on the infant immune system.",2019,"At 7 months of age, seroprotection rates were high in both BCG-vaccinated and BCG-naïve infants.",['infants'],"['neonatal Bacille Calmette-Guérin (BCG) immunisation', 'Bacillus Calmette-Guérin vaccine (BCG', 'BCG', 'neonatal BCG immunisation']","['heterologous vaccine responses', 'antibody responses', 'seroprotection rates', 'geometric mean concentrations (GMC) of antibodies']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0439860', 'cui_str': 'Heterologous (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",,0.0402968,"At 7 months of age, seroprotection rates were high in both BCG-vaccinated and BCG-naïve infants.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zimmermann', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Australia; Infectious Diseases Unit, The Royal Children's Hospital Melbourne, Parkville, Australia; Department of Pediatrics, Fribourg Hospital HFR and Faculty of Science and Medicine, University of Fribourg, Switzerland.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Donath', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Australia.""}, {'ForeName': 'Kirsten P', 'Initials': 'KP', 'LastName': 'Perrett', 'Affiliation': ""Food Allergy Research Group and Melbourne Children's Trial Centre, Murdoch Children's Research Institute, Melbourne, Australia; Departments of Allergy and Immunology and General Medicine, Royal Children's Hospital, Melbourne, Australia; School of Population and Global Health, The University of Melbourne, Parkville, Australia.""}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Messina', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Australia.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ritz', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Unit, University of Basel Children's Hospital, Basel, Switzerland.""}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine, Radboud Institute for Molecular Life Sciences and Radboud Center for Infectious Diseases, Radboud University Nijmegen Medical Center, the Netherlands.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Flanagan', 'Affiliation': 'University of Tasmania, Launceston and Monash University, Clayton, Australia.'}, {'ForeName': 'Fiona R M', 'Initials': 'FRM', 'LastName': 'van der Klis', 'Affiliation': 'National Institute of Public Health and the Environment, Centre for Infectious Diseases, Bilthoven, the Netherlands.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Curtis', 'Affiliation': ""Department of Paediatrics, The University of Melbourne, Parkville, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Australia; Infectious Diseases Unit, The Royal Children's Hospital Melbourne, Parkville, Australia. Electronic address: nigel.curtis@rch.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.03.016']
667,31629805,Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream.,"BACKGROUND


Atopic dermatitis (AD) is a highly pruritic chronic inflammatory skin disorder. Ruxolitinib, a selective inhibitor of Janus kinase 1 and Janus kinase 2, potently suppresses cytokine signaling involved in AD pathogenesis.
OBJECTIVE


We sought to evaluate the efficacy and safety of ruxolitinib (RUX) cream in adults with AD.
METHODS


In this phase 2 study (NCT03011892), 307 adult patients with AD, an Investigator's Global Assessment score of 2 or 3 (mild or moderate), and 3% to 20% affected body surface area were equally randomized for 8 weeks of double-blind treatment to RUX (1.5% twice daily [BID], 1.5% once daily [QD], 0.5% QD, 0.15% QD), vehicle, or triamcinolone cream (0.1% BID for 4 weeks, then vehicle for 4 weeks). Subsequently, patients could apply 1.5% RUX BID for 4 additional weeks of open-label treatment. The primary end point was the comparison between 1.5% RUX cream BID and vehicle in mean percentage change from baseline in Eczema Area and Severity Index at week 4.
RESULTS


All RUX regimens demonstrated therapeutic benefit at week 4; 1.5% BID provided the greatest improvement in Eczema Area and Severity Index (71.6% vs 15.5%; P < .0001) and Investigator's Global Assessment responses (38.0% vs 7.7%; P < .001) versus vehicle. Rapid reductions in the itch numerical rating scale score occurred within 36 hours (1.5% BID vs vehicle, ‒1.8 vs ‒0.2; P < .0001) and were sustained through 12 weeks. Patients who transitioned to 1.5% RUX BID improved in all measures. RUX was not associated with clinically significant application-site reactions.
CONCLUSIONS


RUX cream provided rapid and sustained improvements in AD symptoms and was well tolerated.",2020,"Ruxolitinib, a selective inhibitor of Janus kinase (JAK)-1 and JAK2, potently suppresses cytokine signaling involved in AD pathogenesis.
","['adults with AD', ""307 adult patients with AD, an Investigator's Global Assessment (IGA) score of 2 or 3 (mild or moderate), and 3%‒20% affected body surface area""]","['RUX', 'triamcinolone cream', 'RUX cream', 'ruxolitinib cream', 'Ruxolitinib Cream (JAK1/JAK2 Inhibitor', 'ruxolitinib (RUX) cream', 'Triamcinolone Cream']","['IGA responses', 'tolerated', 'Eczema Area and Severity Index (EASI', 'efficacy and safety', 'therapeutic benefit', 'itch numerical rating scale score', 'AD symptoms', 'EASI', 'atopic dermatitis (AD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]",307.0,0.118593,"Ruxolitinib, a selective inhibitor of Janus kinase (JAK)-1 and JAK2, potently suppresses cytokine signaling involved in AD pathogenesis.
","[{'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo. Electronic address: briankim@wustl.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Howell', 'Affiliation': 'Incyte Corporation, Wilmington, Del.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, Del.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Nasir', 'Affiliation': 'Wake Research Associates LLC, Raleigh, NC.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kuligowski', 'Affiliation': 'Incyte Corporation, Wilmington, Del.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.042']
668,31799996,Effect of Topical Brimonidine on Alcohol-Induced Flushing in Asian Individuals: A Randomized Clinical Trial.,"Importance


Alcohol flushing syndrome (AFS, also known as Asian glow and Asian flush) affects 20% to 47% of East Asians and causes significant psychosocial distress. There are no approved treatments for this condition.
Objective


To determine whether brimonidine gel, 0.33%, decreases facial erythema in patients with AFS after consumption of alcohol.
Design, Setting, and Participants


In this randomized clinical trial, 20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019.
Interventions


Participants were randomized to application of brimonidine gel to either the left or right half of their face. Placebo control was applied to the opposite side. After 30 minutes, participants ingested alcohol.
Main Outcomes and Measures


Outcomes were specified before data collection. The difference in erythema between the treated and placebo side of each participant's face was measured 60 minutes after drug application (primary outcome) and at 90 and 120 minutes after drug application (secondary outcomes). Participants were asked to rate their likelihood of using the medication again and their likelihood of recommending the medication to a friend on a scale of 0 to 10.
Results


The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50%). There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001). This effect persisted at 90 and 120 minutes. Individuals were likely to use the medication again (7.2; 95% CI, 6.0-8.3) and would also recommend it to a friend (7.6; 95% CI, 6.5-8.6).
Conclusions and Relevance


This study demonstrates that brimonidine gel is effective in reducing the facial erythema of AFS. Patients with psychosocial distress due to AFS may benefit from treatment with brimonidine.
Trial Registration


ClinicalTrials.gov identifier: NCT03497442.",2020,"There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001).","['patients with AFS after consumption of alcohol', '20 healthy volunteers of East Asian descent with a self-reported history of AFS were recruited between April 2018 and March 2019', 'Asian Individuals', 'Patients with psychosocial distress', 'The mean (SD) age of the 20 individuals enrolled in the study was 30.5 (8.4) years, and there were 10 women (50']","['Topical Brimonidine', 'brimonidine gel', 'brimonidine', 'Placebo']","['Clinician Erythema Assessment score', 'facial erythema of AFS', 'erythema', 'Subject Self-Assessment score', 'facial erythema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",20.0,0.0595844,"There was a significant difference in erythema at 60 minutes after drug application as measured by the difference in Clinician Erythema Assessment score (2.1; 95% CI, 1.5-2.71; P < .001) and by the difference in Subject Self-Assessment score (1.7; 95% CI, 1.1- 2.3; P < .001).","[{'ForeName': 'Wesley Y', 'Initials': 'WY', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': 'University of California School of Medicine, San Francisco.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Aroyan', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Kanade', 'Initials': 'K', 'LastName': 'Shinkai', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Kieron S', 'Initials': 'KS', 'LastName': 'Leslie', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Lindy P', 'Initials': 'LP', 'LastName': 'Fox', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Siegrid', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Isaac M', 'Initials': 'IM', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Roy C', 'Initials': 'RC', 'LastName': 'Grekin', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}, {'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Arron', 'Affiliation': 'Department of Dermatology, University of California, San Francisco.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3508']
669,24756515,Lorazepam vs diazepam for pediatric status epilepticus: a randomized clinical trial.,"IMPORTANCE


Benzodiazepines are considered first-line therapy for pediatric status epilepticus. Some studies suggest that lorazepam may be more effective or safer than diazepam, but lorazepam is not Food and Drug Administration approved for this indication.
OBJECTIVE


To test the hypothesis that lorazepam has better efficacy and safety than diazepam for treating pediatric status epilepticus.
DESIGN, SETTING, AND PARTICIPANTS


This double-blind, randomized clinical trial was conducted from March 1, 2008, to March 14, 2012. Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible. There were 273 patients; 140 randomized to diazepam and 133 to lorazepam.
INTERVENTIONS


Patients received either 0.2 mg/kg of diazepam or 0.1 mg/kg of lorazepam intravenously, with half this dose repeated at 5 minutes if necessary. If status epilepticus continued at 12 minutes, fosphenytoin was administered.
MAIN OUTCOMES AND MEASURES


The primary efficacy outcome was cessation of status epilepticus by 10 minutes without recurrence within 30 minutes. The primary safety outcome was the performance of assisted ventilation. Secondary outcomes included rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status. Outcomes were measured 4 hours after study medication administration.
RESULTS


Cessation of status epilepticus for 10 minutes without recurrence within 30 minutes occurred in 101 of 140 (72.1%) in the diazepam group and 97 of 133 (72.9%) in the lorazepam group, with an absolute efficacy difference of 0.8% (95% CI, -11.4% to 9.8%). Twenty-six patients in each group required assisted ventilation (16.0% given diazepam and 17.6% given lorazepam; absolute risk difference, 1.6%; 95% CI, -9.9% to 6.8%). There were no statistically significant differences in secondary outcomes except that lorazepam patients were more likely to be sedated (66.9% vs 50%, respectively; absolute risk difference, 16.9%; 95% CI, 6.1% to 27.7%).
CONCLUSIONS AND RELEVANCE


Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam. These findings do not support the preferential use of lorazepam for this condition.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00621478.",2014,"Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam.","['March 1, 2008, to March 14, 2012', 'pediatric status epilepticus', 'pediatric patients with convulsive status epilepticus', 'Patients aged 3 months to younger than 18 years with convulsive status epilepticus presenting to 1 of 11 US academic pediatric emergency departments were eligible', '273 patients; 140 randomized to']","['diazepam or 0.1 mg/kg of lorazepam', 'Lorazepam vs diazepam', 'Benzodiazepines', 'diazepam', 'lorazepam']","['cessation of status epilepticus by 10 minutes without recurrence', 'efficacy or safety', 'assisted ventilation', 'rates of seizure recurrence and sedation and times to cessation of status epilepticus and return to baseline mental status', 'efficacy and safety', 'performance of assisted ventilation']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311335', 'cui_str': 'Grand Mal Status Epilepticus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0038220', 'cui_str': 'Status Epilepticus, Generalized'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0554804', 'cui_str': 'Ventilation assistance'}]",,0.599116,"Among pediatric patients with convulsive status epilepticus, treatment with lorazepam did not result in improved efficacy or safety compared with diazepam.","[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN).""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Okada', 'Affiliation': 'University of Texas, Southwestern, Dallas.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Holsti', 'Affiliation': 'The Pediatric Emergency Care Applied Research Network (PECARN)4Department of Pediatrics, University of Utah, Salt Lake City.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mahajan', 'Affiliation': ""The Pediatric Emergency Care Applied Research Network (PECARN)5Department of Pediatrics, Children's Hospital of Michigan, Detroit.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, DC2The Pediatric Emergency Care Applied Research Network (PECARN).""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Vance', 'Affiliation': 'The Pediatric Emergency Care Applied Research Network (PECARN)6University of California, Davis, Sacramento.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Gonzalez', 'Affiliation': 'The Pediatric Emergency Care Applied Research Network (PECARN)7Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lichenstein', 'Affiliation': 'Department of Pediatrics, University of Maryland, Baltimore.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Stanley', 'Affiliation': 'The Pediatric Emergency Care Applied Research Network (PECARN)9University of Michigan, Ann Arbor.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Brousseau', 'Affiliation': 'The Pediatric Emergency Care Applied Research Network (PECARN)10Department of Pediatrics, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Grubenhoff', 'Affiliation': ""The Pediatric Emergency Care Applied Research Network (PECARN)11Children's Hospital of Colorado, Denver.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Zemek', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': ""Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The EMMES Corp, Rockville, Maryland.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Baren', 'Affiliation': ""The Pediatric Emergency Care Applied Research Network (PECARN)15Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2014.2625']
670,31155969,Cognitive oriented strategy training augmented rehabilitation (COSTAR) for ischemic stroke: a pilot exploratory randomized controlled study.,"Purpose:  To investigate the effect of adding cognitive strategy training to task-specific training (TST), called Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR), compared with TST on activity and participation for chronic stroke survivors in an outpatient occupational therapy setting  Materials and methods:  We conducted an exploratory, single-blind, randomized controlled trial. Participants were randomized to TST or COSTAR protocol. Our primary outcomes measured activity and participation after stroke: the Stroke Impact Scale (SIS), Canadian Occupational Performance Measure (COPM), and Performance Quality Rating Scale (PQRS).  Results:  Forty-four participants were randomized. The COSTAR group had an attrition rate of 50% and an average of 9.8 of 12 sessions were completed; the TST group had an attrition rate of 25% and an average of 10.7 sessions were completed. Generally both groups improved on the majority of primary and secondary outcomes. There is little evidence to support a beneficial effect of COSTAR over TST for improvement of primary measures of activity performance or secondary measures.  Conclusion:  Negligible findings may be attributed to an inadvertent treatment group equivalency. Further, the research design did not allow for adequate measurement of the effect of each intervention on participants' ability to generalize learned skills. Implications for rehabilitation Stroke rehabilitation is largely based upon the principles of task-specific training, which is associated with improvements in upper extremity motor performance; however, TST requires a heavy dosage and lacks generalization to untrained activities. Cognitive strategy use has been associated with improved generalization of treatment to untrained activities and novel contexts however, it is often not used in TST protocols. The results of this preliminary study found no clear advantage between task-specific training and strategy-adapted task-specific training on trained and untrained activities when both interventions targeted activity performance. Task-specific training, if focused at the activity performance level rather than the impairment reduction level, may have a stronger effect on improving in individual's ability to participate in everyday life activities even without the use of cognitive-strategies. Incorporating cognitive strategy-use into TST would likely produce the greatest effect on generalization and transfer of the treatment effects to other activities and contexts rather than solely on activity performance of trained activities.",2019,The results of this preliminary study found no clear advantage between task-specific training and strategy-adapted task-specific training on trained and untrained activities when both interventions targeted activity performance.,"['ischemic stroke', 'chronic stroke survivors in an outpatient occupational therapy setting  Materials and methods', 'Results:  Forty-four participants were randomized']","['Cognitive oriented strategy training augmented rehabilitation (COSTAR', 'TST', 'Task-specific training', 'cognitive strategy training to task-specific training (TST), called Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR']","['attrition rate', 'activity and participation after stroke: the Stroke Impact Scale (SIS), Canadian Occupational Performance Measure (COPM), and Performance Quality Rating Scale (PQRS', 'activity performance']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",44.0,0.055322,The results of this preliminary study found no clear advantage between task-specific training and strategy-adapted task-specific training on trained and untrained activities when both interventions targeted activity performance.,"[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wolf', 'Affiliation': 'a Department of Occupational Therapy , University of Missouri , Columbia , MO , USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'b Department of Occupational Science and Occupational Therapy , Saint Louis University , St. Louis , MO , USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Boone', 'Affiliation': 'a Department of Occupational Therapy , University of Missouri , Columbia , MO , USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rios', 'Affiliation': ""c Sunnybrook Research Institute , St. John's Rehab Program , Toronto , Canada.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Polatajko', 'Affiliation': 'd Department of Occupational Science and Occupational Therapy , University of Toronto , Toronto , Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Baum', 'Affiliation': 'e Program in Occupational Therapy , Washington University School of Medicine , St. Louis , MO , USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'McEwen', 'Affiliation': ""c Sunnybrook Research Institute , St. John's Rehab Program , Toronto , Canada.""}]",Disability and rehabilitation,['10.1080/09638288.2019.1620877']
671,31795799,"Effect of psychological care given to the women who underwent hysterectomy before and after the surgery on depressive symptoms, anxiety and the body image levels.","This study was conducted for the purpose of evaluating the effect of the psychological care given to women before and after hysterectomy surgery on depression levels, anxiety and body image. This experimental study was conducted in the gynecological oncology surgery clinic of Samsun Education and Research Hospital in Turkey between the dates of January 2018 and June 2018. Those who meet the sample selection criterion and agreed to participation to the study among the women who were admitted to the clinic for hysterectomy were assigned randomly to the experimental and control groups. 42 women in total including 21 women in each of experimental and control groups formed the sample of the study. The effect of the psychological care was evaluated through Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI) and Body Catherix Scale (BCS). The evaluation measurements were conducted as pre-test, post-test and follow-up (2-months post-test). The BDI and STAI scores of the women who receive psychological care have decreased and their BPS scores have increased. On the contrary, BDI and STAI scores of the women who receive psychological care in the experimental group have increased and their BCS scores have decreased. These findings show that psychological care has positive effects on depressive symptoms, anxiety and the body image in the women who underwent hysterectomy.IMPACT STATEMENT What is already known on this subject?  Having a hysterectomy impacts a woman's life in a significant manner. As such, deciding to undergo a hysterectomy is a difficult process for women, especially from a psychological perspective. Following a hysterectomy, women commonly experience changes in body perception, such as perceiving the body as different, feeling disabled, feeling hollow, believing they are different than other women and feeling that their body is attracting notice. The literature reports that women perceive themselves as different, alienated, impaired and changed after a hysterectomy and that they have difficulty making contact with the environment; furthermore, the more changes in body perception increase, the more depression increases. What the results of this study add?  This study revealed that psychological care given to women before and after undergoing a hysterectomy decreases anxiety and increases positive body perception. For this reason, psychological care for women undergoing hysterectomies should be part of routine nursing care and should be started upon the hospitalisation of the patient. What are the implications of these findings for clinical practice and/or further research?  The findings of this study indicate that after a hysterectomy, women experience not only physiological disease symptoms but also psychological problems. Therefore, women who have undergone or will undergo a hysterectomy also have psychological needs. Further study is suggested to determine what can be done with a professional team to meet the demands for psychological care.",2020,"These findings show that psychological care has positive effects on depressive symptoms, anxiety and the body image in the women who underwent hysterectomy.","['women who have undergone or will undergo a hysterectomy also have psychological needs', '42 women in total including 21 women in each of experimental and control groups formed the sample of the study', 'women who underwent hysterectomy before and after the surgery on depressive symptoms, anxiety and the body image levels', 'women undergoing hysterectomies', 'women who were admitted to the clinic for hysterectomy', 'gynecological oncology surgery clinic of Samsun Education and Research Hospital in Turkey between the dates of January 2018 and June 2018']","['IMPACT', 'hysterectomy surgery', 'psychological care']","['Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI) and Body Catherix Scale (BCS', 'BPS scores', 'depressive symptoms, anxiety and the body image', 'depression levels, anxiety and body image', 'BCS scores', 'positive body perception', 'BDI and STAI scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035168'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",42.0,0.0212887,"These findings show that psychological care has positive effects on depressive symptoms, anxiety and the body image in the women who underwent hysterectomy.","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Erdoğan', 'Affiliation': 'Sağlık Bilimleri University, Samsun Training and Research Hospital, Samsun, Turkey.'}, {'ForeName': 'Satı', 'Initials': 'S', 'LastName': 'Demir', 'Affiliation': 'Faculty of Health Sciences, Nursing Department, Gazi University, Ankara, Turkey.'}, {'ForeName': 'Behice Belkıs', 'Initials': 'BB', 'LastName': 'Çalışkan', 'Affiliation': 'Faculty of Health Sciences, Nursing Department, İstanbul Aydın University, İstanbul, Turkey.'}, {'ForeName': 'Nurten Gülsüm', 'Initials': 'NG', 'LastName': 'Bayrak', 'Affiliation': 'Giresun A. İlhan Özdemir Training and Research Hospital/Children Follow-up Center, Giresun, Turkey.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2019.1678574']
672,29862630,Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial.,"OBJECTIVE


To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH.
METHODS


We conducted prespecified and post hoc exploratory subgroup analyses from a double-blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade ≥2 surgical complications.
RESULTS


For men with larger prostates (50-80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume.
CONCLUSIONS


In men with moderate-to-severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.",2019,"Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume.
","['men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH', 'men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume']","['aquablation or transurethral resection', 'transurethral resection of the prostate (TURP', 'standard electrocautery vs surgery using robotic waterjet (aquablation', 'TURP']","['IPSS changes', 'International Prostate Symptom Score (IPSS', 'Postoperative anejaculation', 'occurrence of Clavien-Dindo persistent grade 1 or grade ≥2 surgical complications', 'Symptom relief and anejaculation', 'mean IPSS reduction']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0426732', 'cui_str': 'Large prostate (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume (observable entity)'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0278106', 'cui_str': 'Anejaculation (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.329959,"Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume.
","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Plante', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gilling', 'Affiliation': 'Tauranga Urology Research, Tauranga, New Zealand.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Frimley Park Hospital, Frimley Health Foundation Trust, Surrey, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bidair', 'Affiliation': 'San Diego Clinical Trials, San Diego, CA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Anderson', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'Houston Metro Urology, Houston, TX, USA.'}, {'ForeName': 'Tev', 'Initials': 'T', 'LastName': 'Aho', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge, UK.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kramolowsky', 'Affiliation': 'Virginia Urology, Richmond, VA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Princess of Wales Hospital, Bridgend, Wales, UK.'}, {'ForeName': 'Barrett', 'Initials': 'B', 'LastName': 'Cowan', 'Affiliation': 'Urology Associates, P.C., Englewood, CO, USA.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Kaufman', 'Affiliation': 'Albany Medical College, Albany, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trainer', 'Affiliation': 'Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Arther', 'Affiliation': 'Adult Pediatric Urology and Urogynecology, P.C., Omaha, NE, USA.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Badlani', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Institute of Urology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Doumanian', 'Affiliation': 'Institute of Urology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Te', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'DeGuenther', 'Affiliation': 'Urology Centers of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Roehrborn', 'Affiliation': 'Department of Urology, UT Southwestern Medical Center, University of Texas Southwestern, Dallas, TX, USA.'}]",BJU international,['10.1111/bju.14426']
673,31232252,Use It or Lose It? A 5-Year Follow-up Study of Goal Management Training in Patients with Acquired Brain Injury.,"OBJECTIVES


To determine the perceived 5-year outcome of Goal Management Training (GMT) for individuals with chronic acquired brain injury and executive dysfunction, when compared to a nonspecific psychoeducational intervention (Brain Health Workshop, BHW).
METHODS


Of the 67 subjects in the initial randomized controlled trial [Tornås et al. (2016). Journal of the International Neuropsychological Society, 1-17], 50 (GMT, n = 21; BHW, n = 29) subjects returned written consent and questionnaires (54% male, age 45.8 ± 10.9 years). The 5-year follow-up consisted of two questionnaires, including the Behavior Rating Inventory of Executive Function for daily life executive function (EF) and Quality of Life after Brain Injury to assess health-related quality of life (HRQoL). Changes related to daily life EF and HRQoL were assessed pre-treatment, post-treatment, 6-month follow-up, and 5-year follow-up. Data were analyzed using a 2 × 4 mixed-design ANOVA.
RESULTS


The findings indicate that GMT is efficacious in improving EF and HRQoL 6-month post-treatment. However, these changes failed to remain significant at 5-year follow-up.
CONCLUSIONS


Data from 50 participants receiving either GMT or BHW suggested that the significant GMT-related improvements on perceived EF and HRQoL observed at 6-month follow-up were no longer present at 5-year follow-up. These findings indicate a need to promote maintenance of interventions post-treatment.",2019,"The 5-year follow-up consisted of two questionnaires, including the Behavior Rating Inventory of Executive Function for daily life executive function (EF) and Quality of Life after Brain Injury to assess health-related quality of life (HRQoL).","['Patients with Acquired Brain Injury', 'individuals with chronic acquired brain injury and executive dysfunction', 'Journal of the International Neuropsychological Society, 1-17], 50 (GMT, n = 21; BHW, n = 29) subjects returned written consent and questionnaires (54% male, age 45.8 ± 10.9 years', 'Of the 67 subjects in the initial randomized controlled trial', '50 participants receiving either']","['nonspecific psychoeducational intervention', 'GMT or BHW', 'Goal Management Training', 'Goal Management Training (GMT', 'GMT']","['Behavior Rating Inventory of Executive Function for daily life executive function (EF) and Quality of Life after Brain Injury to assess health-related quality of life (HRQoL', 'EF and HRQoL', 'daily life EF and HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034380'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",29.0,0.0432937,"The 5-year follow-up consisted of two questionnaires, including the Behavior Rating Inventory of Executive Function for daily life executive function (EF) and Quality of Life after Brain Injury to assess health-related quality of life (HRQoL).","[{'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Tornås', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Løvstad', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}, {'ForeName': 'Anne-Kristin', 'Initials': 'AK', 'LastName': 'Solbakk', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Kristine', 'Initials': 'AK', 'LastName': 'Schanke', 'Affiliation': 'Department of Research, Sunnaas Rehabilitation Hospital, Nesodden, Norway.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stubberud', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000626']
674,31774468,Long-term Effects of Repeat Hepatectomy vs Percutaneous Radiofrequency Ablation Among Patients With Recurrent Hepatocellular Carcinoma: A Randomized Clinical Trial.,"Importance


Repeat hepatectomy and percutaneous radiofrequency ablation (PRFA) are most commonly used to treat early-stage recurrent hepatocellular carcinoma (RHCC) after initial resection, but previous studies comparing the effectiveness of the 2 treatments have reported conflicting results.
Objective


To compare the long-term survival outcomes after repeat hepatectomy with those after PRFA among patients with early-stage RHCC.
Design, Setting, and Participants


This open-label randomized clinical trial was conducted at the Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer of China. A total of 240 patients with RHCC (with a solitary nodule diameter of ≤5 cm; 3 or fewer nodules, each ≤3 cm in diameter; and no macroscopic vascular invasion or distant metastasis) were randomized 1:1 to receive repeat hepatectomy or PRFA between June 3, 2010, and January 15, 2013. The median (range) follow-up time was 44.3 (4.3-90.6) months (last follow-up, January 15, 2018). Data analysis was conducted from June 15, 2018, to September 28, 2018.
Interventions


Repeat hepatectomy (n = 120) or PRFA (n = 120).
Main Outcomes and Measures


The primary outcome was overall survival (OS). Secondary outcomes included repeat recurrence-free survival (rRFS), patterns of repeat recurrence, and therapeutic safety.
Results


Among the 240 randomized patients (216 men [90.0%]; median [range] age, 53.0 [24.0-59.0] years), 217 completed the trial. In the intention-to-treat (ITT) population, the 1-year, 3-year, and 5-year OS rates were 92.5% (95% CI, 87.9%-97.3%), 65.8% (95% CI, 57.8%-74.8%), and 43.6% (95% CI, 35.5%-53.5%), respectively, for the repeat hepatectomy group and 87.5% (95% CI, 81.8%-93.6%), 52.5% (95% CI, 44.2%-62.2%), and 38.5% (95% CI, 30.6%-48.4%), respectively, for the PRFA group (P = .17). The corresponding 1-year, 3-year, and 5-year rRFS rates were 85.0% (95% CI, 78.8%-91.6%), 52.4% (95% CI, 44.2%-62.2%), and 36.2% (95% CI, 28.5%-46.0%), respectively, for the repeat hepatectomy group and 74.2% (95% CI, 66.7%-82.4%), 41.7% (95% CI, 33.7%-51.5%), and 30.2% (95% CI, 22.9%-39.8%), respectively, for the PRFA group (P = .09). Percutaneous radiofrequency ablation was associated with a higher incidence of local repeat recurrence (37.8% vs 21.7%, P = .04) and early repeat recurrence than repeat hepatectomy (40.3% vs 23.3%, P = .04). In subgroup analyses, PRFA was associated with worse OS vs repeat hepatectomy among patients with an RHCC nodule diameter greater than 3 cm (hazard ratio, 1.72; 95% CI, 1.05-2.84) or an α fetoprotein level greater than 200 ng/mL (hazard ratio, 1.85; 95% CI, 1.15-2.96). Surgery had a higher complication rate than did ablation (22.4% vs 7.3%, P = .001).
Conclusions and Relevance


No statistically significant difference was observed in survival outcomes after repeat hepatectomy vs PRFA for patients with early-stage RHCC. Repeat hepatectomy may be associated with better local disease control and long-term survival in patients with an RHCC diameter greater than 3 cm or an AFP level greater than 200 ng/mL.
Trial Registration


ClinicalTrials.gov identifier: NCT00822562.",2020,No statistically significant difference was observed in survival outcomes after repeat hepatectomy vs PRFA for patients with early-stage RHCC.,"['Patients', '240 randomized patients (216 men [90.0%]; median [range] age, 53.0 [24.0-59.0] years), 217 completed the trial', 'patients with early-stage RHCC', 'Data analysis was conducted from June 15, 2018, to September 28, 2018', '240 patients with RHCC (with a solitary nodule diameter of ≤5 cm; 3 or fewer nodules, each ≤3 cm in diameter; and no macroscopic vascular invasion or distant metastasis', 'With Recurrent Hepatocellular Carcinoma', 'Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer of China']","['Repeat hepatectomy and percutaneous radiofrequency ablation (PRFA', 'repeat hepatectomy or PRFA', 'Percutaneous radiofrequency ablation', 'Interventions\n\n\nRepeat hepatectomy (n\u2009=\u2009120) or PRFA', 'Repeat Hepatectomy vs Percutaneous Radiofrequency Ablation']","['α fetoprotein level', 'long-term survival outcomes', 'survival outcomes', 'overall survival (OS', 'local repeat recurrence', 'repeat recurrence-free survival (rRFS), patterns of repeat recurrence, and therapeutic safety', '5-year OS rates', 'corresponding 1-year, 3-year, and 5-year rRFS rates', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0015950', 'cui_str': 'Fetoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0254792', 'cui_str': 'frr protein'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",240.0,0.325074,No statistically significant difference was observed in survival outcomes after repeat hepatectomy vs PRFA for patients with early-stage RHCC.,"[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Kui', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Guojun', 'Initials': 'G', 'LastName': 'Qian', 'Affiliation': 'Department of Ultrasound Intervention Therapy, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Ultrasound Intervention Therapy, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhengqing', 'Initials': 'Z', 'LastName': 'Lei', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Anfeng', 'Initials': 'A', 'LastName': 'Si', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xuying', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Department of Chinese Traditional Medicine, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Clinical Laboratory, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhangjun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Pawlik', 'Affiliation': 'Department of Surgery, The Ohio State University, Wexner Medical Center, Columbus.'}, {'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Center for Liver Cancer, Key Laboratory of Signaling Regulation and Targeting Therapy of Liver Cancer of the Ministry of Education of China, Shanghai Key Laboratory of Hepatobiliary Tumor Biology, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Wan Yee', 'Initials': 'WY', 'LastName': 'Lau', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Mengchao', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China.'}]",JAMA oncology,['10.1001/jamaoncol.2019.4477']
675,31769240,Switching to Once-Daily Insulin Degludec/Insulin Aspart from Basal Insulin Improves Postprandial Glycemia in Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial.,"BACKGROUND


To explore the efficacy and safety of switching from once-daily basal insulin therapy to once-daily pre-meal injection insulin degludec/insulin aspart (IDegAsp) with respect to the glycemic control of participants with type 2 diabetes mellitus (T2DM).
METHODS


In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, participants on basal insulin therapy were switched to IDegAsp (IDegAsp group;  n =30) or continued basal insulin (Basal group;  n =29). The primary endpoint was the superiority of IDegAsp in causing changes in the daily blood glucose profile, especially post-prandial blood glucose concentration after 12 weeks.
RESULTS


Blood glucose concentrations after dinner and before bedtime were lower in the IDegAsp group, and the improvement in blood glucose before bedtime was significantly greater in the IDegAsp group than in the Basal group at 12 weeks (-1.7±3.0 mmol/L vs. 0.3±2.1 mmol/L,  P <0.05). Intriguingly, glycemic control after breakfast was not improved by IDegAsp injection before breakfast, in contrast to the favorable effect of injection before dinner on blood glucose after dinner. Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol,  P <0.05). Changes in daily insulin dose, body mass, and recorded adverse effects, including hypoglycemia, were comparable between groups.
CONCLUSION


IDegAsp was more effective than basal insulin at reducing blood glucose after dinner and before bedtime, but did not increase the incidence of hypoglycemia. Switching from basal insulin to IDegAsp does not increase the burden on the patient and positively impacts glycemic control in patients with T2DM.",2020,"Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol,  P <0.05).","['participants with type 2 diabetes mellitus (T2DM', 'Patients with Type 2 Diabetes Mellitus', 'patients with T2DM']","['basal insulin therapy were switched to IDegAsp (IDegAsp group;  n =30) or continued basal insulin', 'insulin aspart (IDegAsp', 'Switching to Once-Daily Insulin Degludec/Insulin Aspart from Basal Insulin']","['superiority of IDegAsp in causing changes in the daily blood glucose profile, especially post-prandial blood glucose concentration', 'Changes in daily insulin dose, body mass, and recorded adverse effects, including hypoglycemia', 'Postprandial Glycemia', 'incidence of hypoglycemia', 'blood glucose before bedtime', 'Blood glucose concentrations', 'Glycosylated hemoglobin', 'blood glucose']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0586684,"Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol,  P <0.05).","[{'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Oba-Yamamoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Yanagiya', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Manda', 'Affiliation': 'Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0093']
676,31748208,"Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial.","OBJECTIVE


To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture.
DESIGN


Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial.
SETTING


Secondary care trauma units across 19 hospitals in the United Kingdom's health service.
PARTICIPANTS


Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions.
INTERVENTIONS


Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy).
MAIN OUTCOMES AND MEASURES


Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat.
RESULTS


Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%)  v  38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings.
CONCLUSIONS


There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit.
TRIAL REGISTRATION


ISRCTN54992179.",2019,"No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%)  v  38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates.","['Recruitment commenced in July 2015 and follow-up was completed in March 2018', 'acute Achilles tendon rupture', '230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment', ""Secondary care trauma units across 19 hospitals in the United Kingdom's health service"", 'Participants were 46 years old on average, and 57 (25%) of 230 were female']","['Platelet rich plasma injection', 'platelet rich plasma', 'standard rehabilitation care (ankle immobilisation followed by physiotherapy', 'placebo', 'platelet rich plasma (n=114) or placebo (dry needle; n=116) injection']","['quality and content of platelet rich plasma', 'muscle tendon function', 'muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue', 'heel rise endurance test', 'patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events']","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0040788', 'cui_str': 'Trauma Units'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",230.0,0.706218,"No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%)  v  38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK david.keene@ndorms.ox.ac.uk.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Alsousou', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harrison', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hulley', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wagland', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Parsons', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jacqueline Y', 'Initials': 'JY', 'LastName': 'Thompson', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': ""O'Connor"", 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael Maia', 'Initials': 'MM', 'LastName': 'Schlüssel', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Willett', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.l6132']
677,31188268,"A randomised, double-blind, placebo-controlled crossover trial of the influence of the HCN channel blocker ivabradine in a healthy volunteer pain model: an enriched population trial.","Preclinical studies suggest that type 2 hyperpolarization-activated cyclic nucleotide gated ion channels (HCN2) are necessary for neuropathic pain. This trial assessed the influence of ivabradine, a nonselective HCN channel blocker, on capsaicin-induced hyperalgesia and pain in healthy human subjects. An enriched population comprising subjects who developed >20 cm of punctate hyperalgesia from topical capsaicin (0.5% cream applied onto 9 cm area) was identified. These subjects then received ivabradine (15 mg) or placebo 1 hour before capsaicin application in randomly allocated order in a crossover study. The forearm site for capsaicin alternated with each application of the cream. The interval of time from screening to the first and to the second treatment visits was at least 3 and 5 weeks, respectively, to minimize carryover effects. Fifty-five participants were screened, of which 25 completed at least 1 treatment visit. Intention-to-treat hierarchical analysis revealed no significant effects of the drug on primary trial outcome, defined as a difference in effects of placebo and ivabradine on the area of punctate hyperalgesia (ivabradine - placebo: mean = 3.22 cm, 95% confidence interval: = -4.04 to 10.48, P = 0.37). However, ivabradine caused a slowing of heart rate (difference of 10.10 beats per minute [95% confidence interval -6.48 to -13.73; P-value <0.0001]). We conclude that ivabradine lacks analgesic effects in the capsaicin pain model at a dose that caused appreciable slowing of heart rate and, hence, is unlikely to prove a useful analgesic in humans. More selective drugs are required to establish a role of HCN2 for pain in humans.",2019,"mean=3.22 cm2, 95% CI: = -4.04, 10.48, p=0.37).","['healthy human subjects', '55 participants were screened, of which 25 completed at least one treatment visit', 'healthy volunteer pain model']","['ivabradine', 'topical capsaicin', 'HCN channel blocker ivabradine', 'placebo', 'ivabradine, a non-selective HCN channel blocker', 'placebo and ivabradine', 'capsaicin application', 'capsaicin']","['slowing of heart rate', 'heart rate', 'hyperalgesia and pain']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",55.0,0.494916,"mean=3.22 cm2, 95% CI: = -4.04, 10.48, p=0.37).","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wheeler', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Scholtes', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Armstrong', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University NHS Foundation Trust, Cambridge, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McNaughton', 'Affiliation': 'Wolfson Centre for Age-Related Diseases, Kings College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Menon', 'Affiliation': 'Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}]",Pain,['10.1097/j.pain.0000000000001638']
678,31199549,Observations of Autonomic Variability Following Central Neuromodulation for Chronic Neuropathic Pain in Spinal Cord Injury.,"BACKGROUND


Spinal cord injury (SCI) persons with chronic neuropathic pain (NP) demonstrate maladaptive autonomic profiles compared to SCI counterparts without NP (SCI - NP) or able-bodied (AB) controls. These aberrations may be secondary to maladaptive neuroplasticity in the shared circuitry of the pain neuromatrix-central autonomic network interface (PNM-CAN). In this study, we explored the proposed PNM-CAN mechanism in SCI + NP and AB cohorts following centrally-directed neuromodulation to assess if the PNM and CAN are capable of being differentially modulated.
MATERIALS AND METHODS


Central neuromodulation was administered via breathing-controlled electrical stimulation (BreEStim), previously evidenced to operate at the PNM. To quantify CAN activity, conventional heart rate variability (HRV) recordings were used to gather time and frequency domain parameters of autonomic modulation. SCI + NP (n = 10) and AB (n = 13) cohorts received null and active BreEStim randomly in crossover fashion. HRV data were gathered pretest and 30 minutes posttest. Pain modulation was quantified at both time-points by visual analog scale (VAS) for SCI + NP persons and electrical detection and pain threshold levels (EDT, EPT) for AB persons.
RESULTS


Following active BreEStim only, SCI + NP persons demonstrated increased parasympathetic tone (increased NN50, p = 0.03, and pNN50, p = 0.02, HRV parameters). This parasympathetic restoration was associated with analgesia (VAS reduction, p < 0.01). Similarly, AB persons demonstrated increased noxious tolerance (increased EPT, p = 0.03, with preserved EDL, p = 0.78) only following active BreEStim. However, this increased pain threshold was not associated with autonomic changes.
CONCLUSIONS


Central modulation targeting the PNM produced autonomic changes in SCI + NP persons but not AB persons. These findings suggest that AB persons exhibit intact CAN mechanisms capable of compensating for PNM aberrations or simply that SCI + NP persons exhibit altered PNM-CAN machinery altogether. Our collective findings confirm the interconnectedness and maladaptive plasticity of PNM-CAN machinery in SCI + NP persons and suggest that the PNM and CAN circuitry can be differentially modulated.",2019,"Similarly, AB persons demonstrated increased noxious tolerance (increased EPT, p = 0.03, with preserved EDL, p = 0.78) only following active BreEStim.","['Spinal cord injury (SCI) persons with chronic neuropathic pain (NP', 'Chronic Neuropathic Pain in Spinal Cord Injury']","['breathing-controlled electrical stimulation (BreEStim', 'SCI\u2009+\u2009NP', 'Central Neuromodulation']","['pain threshold', 'parasympathetic tone', 'autonomic changes', 'noxious tolerance', 'Pain modulation']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0209999,"Similarly, AB persons demonstrated increased noxious tolerance (increased EPT, p = 0.03, with preserved EDL, p = 0.78) only following active BreEStim.","[{'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Karri', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Shengai', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'TIRR Memorial Hermann Research Center, TIRR Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Yen-Ting', 'Initials': 'YT', 'LastName': 'Chen', 'Affiliation': 'TIRR Memorial Hermann Research Center, TIRR Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Argyrios', 'Initials': 'A', 'LastName': 'Stampas', 'Affiliation': 'TIRR Memorial Hermann Research Center, TIRR Memorial Hermann Hospital, Houston, TX, USA.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'TIRR Memorial Hermann Research Center, TIRR Memorial Hermann Hospital, Houston, TX, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12979']
679,31190607,Brain and lesion segmentation in multiple sclerosis using fully convolutional neural networks: A large-scale study.,"OBJECTIVE


To investigate the performance of deep learning (DL) based on fully convolutional neural network (FCNN) in segmenting brain tissues in a large cohort of multiple sclerosis (MS) patients.
METHODS


We developed a FCNN model to segment brain tissues, including T2-hyperintense MS lesions. The training, validation, and testing of FCNN were based on ~1000 magnetic resonance imaging (MRI) datasets acquired on relapsing-remitting MS patients, as a part of a phase 3 randomized clinical trial. Multimodal MRI data (dual-echo, FLAIR, and T1-weighted images) served as input to the network. Expert validated segmentation was used as the target for training the FCNN. We cross-validated our results using the leave-one-center-out approach.
RESULTS


We observed a high average (95% confidence limits) Dice similarity coefficient for all the segmented tissues: 0.95 (0.92-0.98) for white matter, 0.96 (0.93-0.98) for gray matter, 0.99 (0.98-0.99) for cerebrospinal fluid, and 0.82 (0.63-1.0) for T2 lesions. High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2  > 0.92 for all tissues). The cross validation showed consistent results across the centers for all tissues.
CONCLUSION


The results from this large-scale study suggest that deep FCNN can automatically segment MS brain tissues, including lesions, with high accuracy.",2019,High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2  > 0.92 for all tissues).,['segmenting brain tissues in a large cohort of multiple sclerosis (MS) patients'],"['Multimodal MRI data (dual-echo, FLAIR, and T1-weighted images', 'deep learning (DL) based on fully convolutional neural network (FCNN']",['Dice similarity coefficient'],"[{'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue (substance)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]",[],,0.039133,High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2  > 0.92 for all tissues).,"[{'ForeName': 'Refaat E', 'Initials': 'RE', 'LastName': 'Gabr', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Coronado', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Electrical Engineering, The University of Texas at Tyler, Houston, TX, USA.'}, {'ForeName': 'Sheeba J', 'Initials': 'SJ', 'LastName': 'Sujit', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Allen', 'Affiliation': 'Texas Advanced Computing Center, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Ponnada A', 'Initials': 'PA', 'LastName': 'Narayana', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519856843']
680,31082669,Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial.,"PURPOSE


Radium 223 dichloride (radium-223) is an alpha particle-emitting bone-directed therapy that prolongs overall survival in men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC). Docetaxel is an antimicrotubule cytotoxic agent that improves survival in mCRPC. We investigated whether combining these potentially cross-sensitising agents to dually target tumour and bone would be safe and effective.
PATIENTS AND METHODS


Phase 1 was a dose escalation study to define a recommended phase 2 dose (RP2D) of docetaxel and radium-223. In phase 2a, patients were randomised 2:1 to the recommended combination regimen or docetaxel at a dose of 75 mg/m 2  every 3 weeks (q3w). Patients with bone-predominant mCRPC were eligible. End-points were safety, efficacy and treatment-related changes in serum and imaging biomarkers.
RESULTS


Twenty patients were enrolled in phase 1; 53 patients were randomised in phase 2a: 36 to combination treatment and 17 to docetaxel alone. The RP2D for the combination was radium-223 55 kBq/kg every six weeks × 5 doses, plus docetaxel 60 mg/m 2  q3w × 10 doses. Febrile neutropenia was dose limiting. A higher rate of febrile neutropenia was seen in the docetaxel monotherapy arm (15% vs 0%); the safety profile of the treatment groups was otherwise similar. The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
CONCLUSIONS


Radium-223 in combination with docetaxel at the RP2D was well tolerated. Exploratory efficacy data suggested enhanced antitumour activity for the combination relative to docetaxel alone. Comparative studies with end-points of clinical benefit are warranted. ClinicalTrials.gov number: NCT01106352.",2019,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","['patients with castration-resistant prostate cancer and bone metastases', 'men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC', 'Twenty patients were enrolled in phase 1; 53 patients', 'Patients with bone-predominant mCRPC were eligible']","['Radium 223 dichloride', 'plus docetaxel 60\xa0mg/m 2  q3w', 'Radium-223 in combination with docetaxel', 'docetaxel', 'docetaxel alone', 'docetaxel and radium-223', 'Docetaxel']","['tolerated', 'alkaline phosphatase', 'antitumour activity', 'safety profile', 'Febrile neutropenia', 'rate of febrile neutropenia', 'durable suppression of prostate-specific antigen', 'safety, efficacy\xa0and treatment-related changes in serum and imaging biomarkers', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]","[{'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",20.0,0.0447673,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA. Electronic address: morrism@mskcc.org.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Shevrin', 'Affiliation': 'NorthShore Medical Group, NorthShore University Health System, Evanston Hospital Kellogg Cancer Center, Evanston, IL, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Pandit-Taskar', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'Deandreis', 'Affiliation': 'Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': ""Department of Imaging, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Vesselle', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Carrasquillo', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Department of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.007']
681,31155413,A post-hoc analysis of serotype-specific vaccine efficacy of 13-valent pneumococcal conjugate vaccine against clinical community acquired pneumonia from a randomized clinical trial in the Netherlands.,"BACKGROUND


Serotype-specific vaccine efficacy (VE) against adult community acquired pneumonia (CAP) remains poorly defined, yet such data are important for assessing the utility of adult pneumococcal conjugate vaccine (PCV) programs.
METHODS


We evaluated the Community Acquired Pneumonia Immunization Trial in Adults to assess serotype-specific VE for CAP. This parallel-arm randomized clinical trial assessed 13-valent PCV (PCV13) VE among community dwelling persons aged ≥65 years in The Netherlands. In the original analysis, PCV13 VE against first episodes of vaccine-type (VT) chest radiology confirmed CAP was 45.6% (95% confidence interval [CI] 21.8-62.5%). Unlike the original analysis, we included any subject that met a clinical definition of CAP regardless of radiographic findings. VT-CAP was identified by culture (sterile or non-sterile) or serotype-specific urinary antigen detection (SSUAD) test. Only the five serotypes with at least 10 episodes in the control arm, based on the original analysis, were included for VE assessment.
RESULTS


Of 272 clinical CAP visits with VT serotypes identified, 253 (93%) were identified by SSUAD including 210 (77%) by SSUAD alone. VE was determined for serotypes 1, 3, 6A, 7F, and 19A, with total first episodes of, respectively, 27, 36, 25, 38, and 48. VE (95%CI) for the five evaluated serotypes against first clinical CAP episodes were: serotype 1, 20.0% (-83.1% to 65.8%); serotype 3, 61.5% (17.6-83.4%); serotype 6A, 33.3% (-58.6% to 73.2%); serotype 7F, 73.3% (40.5-89.4%); and serotype 19A, 45.2% (-2.2% to 71.5%).
DISCUSSION


Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults. The VE point estimates and CIs for serotypes 1, 6A, and 19A were lower but consistent with the overall VT-CAP VE of 45.6% previously reported. These findings may be relevant in models to accurately account for the potential impact of adult PCV13 immunization.",2019,Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults.,"['elderly community dwelling adults', 'community dwelling persons aged ≥65\u202fyears in The Netherlands', 'Adults to assess serotype-specific VE for CAP', 'adult community acquired pneumonia (CAP']","['13-valent PCV (PCV13) VE', '13-valent pneumococcal conjugate vaccine']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}]","[{'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]",[],,0.180764,Statistically significant VE was observed for serotypes 3 and 7F for clinical CAP among elderly community dwelling adults.,"[{'ForeName': 'Bradford D', 'Initials': 'BD', 'LastName': 'Gessner', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA. Electronic address: Bradford.gessner@Pfizer.com.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'Van Werkhoven', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Sings', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Pfizer Vaccines, Clinical Research and Development, Hurley, United Kingdom; Pearl River, NY, USA; Collegeville, PA, USA.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Julius Clinical, Academic Contract Research Organization, Zeist, the Netherlands.'}, {'ForeName': 'Marc J M', 'Initials': 'MJM', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, the Netherlands; Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jodar', 'Affiliation': 'Pfizer Vaccines, Collegeville, PA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.05.065']
682,31749128,"Putative Probiotic Strains Isolated from Kefir Improve Gastrointestinal Health Parameters in Adults: a Randomized, Single-Blind, Placebo-Controlled Study.","The dairy products remain as the largest reservoir for isolation of probiotic microorganisms. While probiotics have been immensely reported to exert various health benefits, it is also a common notion that these health potentials are strain and host dependent, leading to the need of more human evidence based on specific strains, health targets, and populations. This randomized, single-blind, and placebo-controlled human study aimed to evaluate the potential benefits of putative probiotic strains isolated from kefir on gastrointestinal parameters in fifty-six healthy adults. The consumption of AB-kefir (Bifidobacterium longum, Lactobacillus acidophilus, L. fermentum, L. helveticus, L. paracasei, L. rhamnosus, and Streptococcus thermophiles; total 10 log CFU/sachet) daily for 3 week reduced symptoms of abdominal pain, bloating (P = 0.014), and appetite (P = 0.041) in male subjects as compared to the control. Gut microbiota distribution profiles were shifted upon consumption of AB-kefir compared to baseline, where the abundance of bifidobacteria was increased in male subjects and maintained upon cessation of AB-kefir consumption. The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks. Our results indicated that AB-kefir could potentially be developed as a natural strategy to improve gastrointestinal functions in adults.",2020,The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks.,"['adults', 'Adults', 'male subjects', 'fifty-six healthy adults']","['placebo', 'Placebo', 'putative probiotic strains isolated from kefir']","['appetite', 'abundance of bifidobacteria', 'total bacterial', 'symptoms of abdominal pain, bloating', 'gastrointestinal functions', 'gastrointestinal abundance of total anaerobes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0524649', 'cui_str': 'Kefir'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0004613', 'cui_str': 'Bacteria, Anaerobic'}]",56.0,0.025813,The consumption of AB-kefir also increased gastrointestinal abundance of total anaerobes (P = 0.038) and total bacterial (P = 0.049) in female subjects compared to the control after 3 weeks.,"[{'ForeName': 'Ming-Cheng', 'Initials': 'MC', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Ahmad Imran', 'Initials': 'AI', 'LastName': 'Zaydi', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia.'}, {'ForeName': 'Wei-Hung', 'Initials': 'WH', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Jin-Seng', 'Initials': 'JS', 'LastName': 'Lin', 'Affiliation': 'Culture Collection and Research Institute, SYNBIO TECH INC., Kaohsiung, Taiwan.'}, {'ForeName': 'Min-Tze', 'Initials': 'MT', 'LastName': 'Liong', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, 11800, Penang, Malaysia. mintze.liong@usm.my.'}, {'ForeName': 'Jiunn-Jong', 'Initials': 'JJ', 'LastName': 'Wu', 'Affiliation': 'Department of Biotechnology and Laboratory Science in Medicine, School of Biomedical Science and Engineering, National Yang Ming University, Taipei, Taiwan. jjwu1019@ym.edu.tw.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-019-09615-9']
683,31913085,Effects of desvenlafaxine versus placebo on MDD symptom clusters: A pooled analysis.,"BACKGROUND


Major depressive disorder is characterized by the presence of at least five of nine specific symptoms that contribute to clinically significant functional impairment. This analysis examined the effect of desvenlafaxine (50 or 100 mg) versus placebo on symptom cluster scores and the association between early improvement in symptom clusters and symptomatic or functional remission at week 8.
METHODS


Using data from nine double-blind, placebo-controlled studies of desvenlafaxine for the treatment of major depressive disorder ( N =4317), the effect of desvenlafaxine 50 or 100 mg versus placebo on scores for symptom clusters based on 17-item Hamilton Rating Scale for Depression items was assessed using analysis of covariance. Association between early improvement in symptom clusters (⩾20% improvement from baseline at week 2) and symptomatic and functional remission (17-item Hamilton Rating Scale for Depression total score ⩽7; Sheehan Disability Scale score <7) at week 8 was analyzed using logistic regression. Symptom clusters based on Montgomery-Åsberg Depression Rating Scale were also examined.
RESULTS


Desvenlafaxine 50 or 100 mg was associated with significant improvement from baseline compared to placebo for all symptom clusters ( p <0.001), except a sleep cluster for desvenlafaxine 100 mg. For all symptom clusters, early improvement was significantly associated with achievement of symptomatic and functional remission at week 8 for all treatment groups ( p ⩽0.0254).
CONCLUSION


Early improvement in symptom clusters significantly predicts symptomatic or functional remission at week 8 in patients with depression receiving desvenlafaxine (50 or 100 mg) or placebo. Importantly, patients without early improvement were less likely to remit.",2020,"For all symptom clusters, early improvement was significantly associated with achievement of symptomatic and functional remission at week 8 for all treatment groups ( p ⩽0.0254).
","['MDD symptom clusters', 'major depressive disorder ( N =4317']","['desvenlafaxine', 'Desvenlafaxine', 'placebo']","['17-item Hamilton Rating Scale for Depression items', 'symptom clusters', 'achievement of symptomatic and functional remission', 'symptomatic and functional remission (17-item Hamilton Rating Scale for Depression total score ⩽7; Sheehan Disability Scale score', 'symptom clusters and symptomatic or functional remission', 'Montgomery-Åsberg Depression Rating Scale', 'symptom cluster scores', 'symptomatic or functional remission']","[{'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",,0.137175,"For all symptom clusters, early improvement was significantly associated with achievement of symptomatic and functional remission at week 8 for all treatment groups ( p ⩽0.0254).
","[{'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Katzman', 'Affiliation': 'START Clinic for Mood and Anxiety Disorders, Toronto, ON, Canada.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Syneos Health, Inc., Raleigh, NC, USA.'}, {'ForeName': 'Dalia B', 'Initials': 'DB', 'LastName': 'Wajsbrot', 'Affiliation': 'Pfizer, Inc., New York, NY, USA.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boucher', 'Affiliation': 'Pfizer Canada, Inc., Kirkland, QC, Canada.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119896066']
684,31911641,Comparison of extubation success using noninvasive positive pressure ventilation (NIPPV) versus noninvasive neurally adjusted ventilatory assist (NI-NAVA).,"OBJECTIVE


Compare rates of initial extubation success in preterm infants extubated to NIPPV or NI-NAVA.
STUDY DESIGN


In this pilot study, we randomized 30 mechanically ventilated preterm infants at the time of initial elective extubation to NI-NAVA or NIPPV in a 1:1 assignment. Primary study outcome was initial extubation success.
RESULTS


Rates of continuous extubation for 120 h were 92% in the NI-NAVA group and 69% in the NIPPV group (12/13 vs. 9/13, respectively, p = 0.14). Infants extubated to NI-NAVA remained extubated longer (median 18 vs. 4 days, p = 0.02) and experienced lower peak inspiratory pressures (PIP) than infants managed with NIPPV throughout the first 3 days after extubation. Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.
CONCLUSIONS


Our study is the first to suggest that a strategy of extubating preterm infants to NI-NAVA may be more successful.",2020,"Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.
","['30 mechanically ventilated preterm infants at the time of initial elective extubation to NI-NAVA or NIPPV in a 1:1 assignment', 'preterm infants extubated to NIPPV or NI-NAVA']",['noninvasive positive pressure ventilation (NIPPV) versus noninvasive neurally adjusted ventilatory assist (NI-NAVA'],"['peak inspiratory pressures (PIP', 'initial extubation success', 'Rates of continuous extubation', 'Infants extubated to NI-NAVA remained extubated longer']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}]","[{'cui': 'C3164735', 'cui_str': 'Noninvasive positive pressure ventilation (procedure)'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}]","[{'cui': 'C0232021', 'cui_str': 'Maximum inspiratory pressure (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",30.0,0.203056,"Survival analysis through 14 days post extubation showed a sustained difference in the primary study outcome until 12 days post extubation.
","[{'ForeName': 'Kartikeya', 'Initials': 'K', 'LastName': 'Makker', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA. kmakker@gmail.com.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Cortez', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Kanishk', 'Initials': 'K', 'LastName': 'Jha', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Nandula', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lowrie', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Smotherman', 'Affiliation': 'Center for Health Equity and Research (CHEQR), University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Center for Health Equity and Research (CHEQR), University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0578-4']
685,31912274,"""She is Like a Sister to Me."" Gender-Affirming Services and Relationships are Key to the Implementation of HIV Care Engagement Interventions with Transgender Women of Color.","We present findings from qualitative interviews (N = 67) with 36 staff and 31 participants of nine distinct individual and/or group level interventions to engage transgender women of color (TWOC) in HIV care in the U.S. We examine the commonalities amongst the intervention services (addressing unmet basic needs, facilitating engagement in HIV care, health system navigation, improving health literacy, emotional support), and the relationships formed during implementation of the interventions (between interventionists and participants, among participants in intervention groups, between participants and peers in the community). Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community. Intervention groups engaged participants to reinforce the importance of health and HIV care and provided mutual support. Gender affirming services and caring relationships may be two key characteristics of interventions that address individual and structural-level barriers to engage TWOC in HIV care.",2020,"Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community.",[],['nine distinct individual and/or group level interventions to engage transgender women of color (TWOC) in HIV care in the U.S'],[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],,0.045641,"Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community.","[{'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 550 16th Street, 3rd floor, Box 0886, San Francisco, CA, 94143, USA. andres.maiorana@ucsf.edu.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Sevelius', 'Affiliation': 'Center for AIDS Prevention Studies and Center of Excellence for Transgender Health, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'JoAnne', 'Initials': 'J', 'LastName': 'Keatley', 'Affiliation': 'Center of Excellence for Transgender Health, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rebchook', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 550 16th Street, 3rd floor, Box 0886, San Francisco, CA, 94143, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02777-6']
686,31756117,Comparison of change in body weight between contraception containing 30-μg ethinylestradiol/2-mg chlormadinone acetate or 30-μg ethinylestradiol/3-mg drospirenone: a randomised controlled trial.,"Objectives:  The aim of this study was to compare changes in body weight in women using a combined oral contraceptive (COC) consisting of 30-μg ethinylestradiol (EE) and 2-mg chlormadinone acetate (CMA) or a COC consisting of 30-μg EE and 3-mg drospirenone (DRSP). Methods:  This randomised double-blind controlled trial (ClinicalTrials.gov NCT01608698) was conducted at a university hospital-based clinic in Thailand between June 2012 and September 2015. A total of 102 women were enrolled in the study, 99 of whom were randomised to EE/CMA (n = 45) or EE/DRSP (n = 54). Each participant was treated for six cycles. Body weight and other parameters as well as side effects were recorded at baseline and at the end of the third and sixth cycles of treatment. Results:  A significant difference was observed in mean body weight change between the EE/CMA and EE/DRSP groups from both baseline to third cycle (0.51 ± 1.36 kg vs -0.43 ± 1.56 kg;  p  = .003) and baseline to sixth cycle (1.00 ± 1.84 kg vs -0.20 ± 2.23 kg;  p  = .013). The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight. There was no significant difference in side effects between groups. Conclusion:  A COC containing 30-µg EE/3-mg DRSP tended to confer a significantly more favourable change in body weight over a 6-month period compared with a COC containing 30-µg EE/2-mg CMA, which was associated with an increase in body weight.",2020,The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight.,"['university hospital-based clinic in Thailand between June 2012 and September 2015', 'women using a', 'A total of 102 women were enrolled in the study, 99 of whom were randomised to']","['ethinylestradiol/2-mg chlormadinone acetate or 30-μg ethinylestradiol/3-mg drospirenone', 'EE/CMA', 'EE/DRSP', 'combined oral contraceptive (COC) consisting of 30-μg ethinylestradiol (EE) and 2-mg chlormadinone acetate (CMA) or a COC consisting of 30-μg EE and 3-mg drospirenone (DRSP']","['body mass index and waist circumference', 'side effects', 'mean body weight change', 'body weight', 'Body weight and other parameters as well as side effects']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0008214', 'cui_str': 'Chlormadinone Acetate'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0009906', 'cui_str': 'Contraceptive Agents, Female, Combined'}, {'cui': 'C0015011', 'cui_str': 'Ethinyl Estradiol'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",102.0,0.271867,The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight.,"[{'ForeName': 'Thanyarat', 'Initials': 'T', 'LastName': 'Wongwananuruk', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Nalinee', 'Initials': 'N', 'LastName': 'Panichyawat', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tachjaree', 'Initials': 'T', 'LastName': 'Panchalee', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Preeyaporn', 'Initials': 'P', 'LastName': 'Jirakittidul', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Angsuwathana', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Korakot', 'Initials': 'K', 'LastName': 'Sirimai', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manopchai', 'Initials': 'M', 'LastName': 'Thamkhantho', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Gessuda', 'Initials': 'G', 'LastName': 'Chiravacharadej', 'Affiliation': 'Family Planning and Reproductive Health Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception,['10.1080/13625187.2019.1688290']
687,31754697,Biomarkers of Docosahexaenoic Acid but Not Arachidonic Acid Reflect Dietary Intakes in Toddlers at Ages 1 and 2 Years Who Are Not Meeting Dietary Recommendations.,"BACKGROUND


Long-chain n-6 and n-3 PUFAs are important for growth and development. However, little is known about requirements and current dietary intakes of these fatty acids in toddlers.
OBJECTIVES


This study assessed dietary intakes of n-6 and n-3 PUFAs and determined the relation to circulating PUFAs in toddlers at ages 1 and 2 y.
METHODS


This is a secondary analysis of data from toddlers enrolled in a double-blind randomized controlled trial of arachidonic acid (ARA) and DHA supplementation between ages 1 and 2 y. Dietary intakes of fatty acids were estimated by 3-d food records, and fatty acid composition in plasma total phospholipids, red blood cell phosphatidylethanolamine (PE), and phosphatidylcholine (PC) were assessed by GC at baseline in all subjects (n = 110; mean age 1.12 y; 64% male) and in the control subjects at 2 y (n = 43).
RESULTS


The dietary intakes of ARA, EPA, and DHA at age 1 y (baseline) were [mean (median)] 36.8 (30.0), 16.0 (0.00), and 31.1 (10.0) mg/d, respectively. Dietary intakes increased to 52.7 (45.0), 35.8 (0.00), and 64.8 (20.0) mg/d, respectively, at age 2 y (P < 0.05). The predominant dietary source of EPA and DHA was fish/seafood; eggs were an important source of ARA and DHA. Dietary DHA intakes were positively associated with plasma PE and PC DHA (P < 0.05). No relations between dietary ARA intakes and plasma PE and PC ARA (P > 0.05) were observed.
CONCLUSIONS


These findings suggest that most toddlers are not meeting the recommendation for dietary PUFA intakes and that higher dietary DHA intakes are reflected in plasma PE and PC DHA composition. Further work is required to investigate a biomarker for dietary ARA intake. This trial is registered at clinicaltrials.gov as NCT01263912.",2020,Dietary DHA intakes were positively associated with plasma PE and PC DHA (P < 0.05).,"['Toddlers at Ages 1 and 2 Years Who Are Not Meeting Dietary Recommendations', 'all subjects (n\xa0=\xa0110; mean age 1.12 y; 64% male) and in the control subjects at 2 y (n\xa0=\xa043', 'toddlers at ages 1 and 2 y.\nMETHODS']","['Arachidonic Acid', 'Docosahexaenoic Acid', 'n-6 and n-3 PUFAs', 'arachidonic acid (ARA) and DHA supplementation']","['plasma PE and PC DHA', 'Dietary intakes', 'dietary intakes of ARA, EPA, and DHA', 'plasma PE and PC DHA composition', 'plasma total phospholipids, red blood cell phosphatidylethanolamine (PE), and phosphatidylcholine (PC', 'dietary ARA intakes and plasma PE and PC ARA', 'Dietary DHA intakes']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1168488', 'cui_str': 'Total phospholipids'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C1959616', 'cui_str': 'Phosphatidyl Cholines'}]",,0.0932511,Dietary DHA intakes were positively associated with plasma PE and PC DHA (P < 0.05).,"[{'ForeName': 'Alejandra M', 'Initials': 'AM', 'LastName': 'Wiedeman', 'Affiliation': ""Department of Pediatrics, The University of British Columbia and BC Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Dyer', 'Affiliation': ""Department of Pediatrics, The University of British Columbia and BC Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'DSM Nutritional Products, Columbia, MD, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Yurko-Mauro', 'Affiliation': 'DSM Nutritional Products, Columbia, MD, USA.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Innis', 'Affiliation': ""Department of Pediatrics, The University of British Columbia and BC Children's Hospital Research Institute, Vancouver, Canada.""}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Devlin', 'Affiliation': ""Department of Pediatrics, The University of British Columbia and BC Children's Hospital Research Institute, Vancouver, Canada.""}]",The Journal of nutrition,['10.1093/jn/nxz280']
688,31148332,Investigating optimal β-cell-preserving treatment in latent autoimmune diabetes in adults: Results from a 21-month randomized trial.,"AIMS


To compare outcomes of glucagon-stimulated C-peptide tests (GSCTs) in people with latent autoimmune diabetes in adults (LADA) after a 21-month intervention with either insulin or the dipeptidyl peptidase-4 inhibitor sitagliptin.
RESEARCH DESIGN AND METHODS


We included 64 glutamic acid decarboxylase (GAD) antibody-positive individuals, who were diagnosed with diabetes <3 years before the study, aged 30 to 70 years, and without clinical need for insulin treatment. We stratified participants by age and body mass index (BMI) and evaluated β-cell function by GSCT after a 48-hour temporary withdrawal of study medication.
RESULTS


Age at randomization (mean 53 years), BMI (mean 27 kg/m 2  ) and metabolic markers were similar between treatment arms. Glycated haemoglobin concentrations during intervention did not differ between arms. Fasting C-peptide concentrations after the intervention were similar, as were stimulated C-peptide levels (0.82 ± 0.63 nmol/L after insulin, 0.82 ± 0.46 nmol/L after sitagliptin; nonsignificant). Autoimmunity in the study population (estimated from GAD antibody titres and positivity/no positivity for zinc transporter 8 and islet antigen 2 antibodies) affected the evolution of the GSCT results significantly, which deteriorated in participants with high but not in those with low autoimmunity. Adjustment using analysis of covariance for the degree of autoimmunity did not alter the findings of no difference between treatment arms.
CONCLUSIONS


β-cell function after intervention was similar in patients with insulin- and sitagliptin-treated LADA, regardless of the strength of autoimmunity. Further, participants with low levels of GAD antibodies did not experience progressive deterioration of β-cell function over a 21-month period. Taken together, these findings could be useful for clinicians' choices of treatment in people with LADA.",2019,"Fasting C-peptide concentrations after the intervention were similar, as were stimulated C-peptide levels (0.82 ± 0.63 nmol/L after insulin, 0.82 ± 0.46 nmol/L after sitagliptin; nonsignificant).","['64 glutamic acid decarboxylase (GAD) antibody-positive individuals, who were diagnosed with diabetes <3\u2009years before the study, aged 30 to 70\u2009years, and without clinical need for insulin treatment', 'stratified participants by age and body mass index (BMI) and evaluated β-cell function by GSCT after a 48-hour temporary withdrawal of study medication', 'people with LADA', 'people with latent autoimmune diabetes in adults (LADA) after a 21-month intervention with either insulin or the dipeptidyl peptidase-4 inhibitor sitagliptin', 'Age at randomization', 'latent autoimmune diabetes in adults']",['glucagon-stimulated C-peptide tests (GSCTs'],"['Fasting C-peptide concentrations', 'Glycated haemoglobin concentrations', 'metabolic markers', 'BMI']","[{'cui': 'C0443891', 'cui_str': 'Glutamic acid decarboxylase antibody (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}]",64.0,0.108357,"Fasting C-peptide concentrations after the intervention were similar, as were stimulated C-peptide levels (0.82 ± 0.63 nmol/L after insulin, 0.82 ± 0.46 nmol/L after sitagliptin; nonsignificant).","[{'ForeName': 'Ingrid K', 'Initials': 'IK', 'LastName': 'Hals', 'Affiliation': 'Department of Endocrinology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Fiskvik Fleiner', 'Affiliation': 'Department of Clinical Pharmacology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Reimers', 'Affiliation': 'Department of Endocrinology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.'}, {'ForeName': 'Marianne C', 'Initials': 'MC', 'LastName': 'Astor', 'Affiliation': 'Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Filipsson', 'Affiliation': 'Department of Clinical Sciences, Lund University, Malmö, Sweden.'}, {'ForeName': 'Zuheng', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Molecular Medicine and Surgery, Endocrine and Diabetes Unit, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Valdemar', 'Initials': 'V', 'LastName': 'Grill', 'Affiliation': 'Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Björklund', 'Affiliation': 'Department of Molecular Medicine and Surgery, Endocrine and Diabetes Unit, Karolinska University Hospital, Stockholm, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13797']
689,31747846,"The Efficacy of a Resilience Intervention Among Diverse, At-Risk, College Athletes: A Mixed-Methods Study.","BACKGROUND:  Adverse childhood experiences (ACEs) have been associated with psychological and physiological disease, and risky health behaviors. A person's ability to be resilient may protect them from these negative health outcomes, as resilience has been associated with increased emotional awareness, coping, belonging, and greater likelihood of good health and well-being.  AIMS:  The purpose of this pilot study was to assess the efficacy of a strengths-based resilience intervention to improve access to internal and external resources that effect perceptions of stress, resilience, emotional awareness, and belonging among student-athletes.  METHODS:  A mixed-methods design was used to examine variables of interest between intervention and control groups. A sample of 56 college athletes completed surveys and engaged in expressive writing during a 5-week resilience intervention.  RESULTS:  Self-report data indicated that student-athletes in the intervention group improved decision making, lowered perceived stress, and increased resilience compared with controls. Of note, participants with ACEs showed greater increments of positive change in emotional awareness scales than participants without ACEs. Descriptions of emotion management, authentic connections, and increased ability to request support from others were identified in the qualitative data.  CONCLUSIONS:  A strengths-based course designed to increase resilience-offered as academic and athletic stress is mounting-provided a unique opportunity to promote student-athlete success. Participants gained skills key to victory on and off the field, including health-promoting behaviors, a sense of belonging, persistence, and the ability to negotiate external resources.",2020,"Self-report data indicated that student-athletes in the intervention group improved decision making, lowered perceived stress, and increased resilience compared with controls.","['Diverse, At-Risk, College Athletes', '56 college athletes completed surveys and engaged in expressive writing during a 5-week resilience intervention']",['strengths-based resilience intervention'],['positive change in emotional awareness scales'],"[{'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0222045'}]",,0.034505,"Self-report data indicated that student-athletes in the intervention group improved decision making, lowered perceived stress, and increased resilience compared with controls.","[{'ForeName': 'Genevieve E', 'Initials': 'GE', 'LastName': 'Chandler', 'Affiliation': 'Genevieve E. Chandler, PhD, RN, University of Massachusetts Amherst, MA, USA.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Kalmakis', 'Affiliation': 'Karen A. Kalmakis, PhD, MPH, FNP, FAANP, University of Massachusetts Amherst, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chiodo', 'Affiliation': 'Lisa Chiodo, PhD, University of Massachusetts Amherst, MA, USA.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Helling', 'Affiliation': 'Jim Helling, LICSW, University of Massachusetts Amherst, MA, USA.'}]",Journal of the American Psychiatric Nurses Association,['10.1177/1078390319886923']
690,31115032,The efficacy of simendan in the treatment of acute heart failure and its impact on NT-proBNP.,"OBJECTIVE


Simendan is a calcium sensitizer that enhances myocardial contractility but does not affect ventricular diastole. Simendan also has a vasodilatation effect, which causes coronary artery resistance and venous volume blood vessel relax, thereby improving coronary blood supply. This study adopted simendan on the basis of conventional anti-heart failure treatment to explore a new approach for the treatment of heart failure.
PATIENTS AND METHODS


Eighty patients with heart failure were randomly and equally divided into an observation group and control group according to the digital table method. The control group was given a conventional anti-heart failure treatment. The observation group was treated with simendan on the basis of the control group. The left ventricular ejection fraction (LEVF), stroke volume (SV), NT-proBNP, K+, and Ca2+ were measured before and after the treatment. The clinical efficacy and adverse reactions after treatment were compared. The 6-minute walking distance (6MWT) was recorded on the 60th day after treatment.
RESULTS


There were no significant differences in LVEF and SV between the two groups before the treatment. They were significantly increased after treatment and were significantly higher in the observation group than that in the control group (p < 0.05). The total effective rate in the observation group (92.50%) was significantly higher than that in the control group (67.50%). There was no statistical difference in the occurrence of adverse reactions between the two groups (p > 0.05). The 6MWT in the observation group was 452.63±86.51 meters, which was significantly higher than that in the control group (366.85±70.46 meters) (p < 0.05). There was no significant difference in plasma NT-proBNP levels between the two groups (p > 0.05). The plasma NT-proBNP level was significantly lower in the observation group than that in the control group after treatment (p < 0.05). Serum K+ and Ca2+ were not significantly changed after treatment in the control group (p > 0.05). Serum K+, but not Ca2+, was significantly elevated in the observation group.
CONCLUSIONS


Simendan can significantly reduce plasma NT-proBNP level; thus, it is relatively safe and effective for the treatment of acute heart failure (AHF).",2019,There was no significant difference in plasma NT-proBNP levels between the two groups (p > 0.05).,['Eighty patients with heart failure'],"['conventional anti-heart failure treatment', 'simendan']","['clinical efficacy and adverse reactions', 'occurrence of adverse reactions', 'LVEF and SV', 'Serum K+ and Ca2', 'Serum K', '6-minute walking distance (6MWT', 'myocardial contractility', 'total effective rate', 'plasma NT-proBNP level', 'plasma NT-proBNP levels', 'left ventricular ejection fraction (LEVF), stroke volume (SV), NT-proBNP, K+, and Ca2']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0287806', 'cui_str': '((4-(1,4,5,6-tetrahydro-4-methyl-6-oxo-3-pyridazinyl)phenyl)hydrazono)propanedinitrile'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2603574', 'cui_str': 'Ca(BD4)2'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}]",80.0,0.0174552,There was no significant difference in plasma NT-proBNP levels between the two groups (p > 0.05).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of General Medicine, Affiliated Hospital of Hebei University of Engineering, Handan, Heibei, China. rtlb5n1b7r3f@sina.com.'}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Z-Y', 'Initials': 'ZY', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201905_17833']
691,31393319,Impact of Stressful Climates on Provider Perceptions of Integrated Behavioral Health Services in Pediatric Primary Care: An Exploratory Study.,"OBJECTIVE


Pediatric primary care providers (PCPs) work in challenging environments and are increasingly called to implement complex interventions, such as behavioral health (BH) service integration. We explore how perceived stressful practice climates (1) change over time in and (2) influence provider perceptions of collaborative care versus usual care, 2 models of integrated BH care.
METHODS


Secondary exploratory analysis using hierarchical linear modeling was performed on an 18-month cluster-randomized trial of 8 pediatric primary care practices to Doctor-Office Collaborative Care (DOCC), where an on-site care manager delivered BH services in coordination with PCPs, or Enhanced Usual Care (EUC), where a care manager facilitated referrals to local BH providers. Various indicators of PCP perceptions of BH services, including satisfaction with practice, burdens and beliefs regarding psychosocial problems, and effectiveness in treating behavioral problems, were assessed as outcomes. Moderators were 2 domains of stressful climates, role conflict and role overload.
RESULTS


Role conflict and role overload stayed stable in both conditions. Role conflict strengthened the positive effect of DOCC on PCP perceived effectiveness in treating behavioral problems (β [SE], 0.04 [0.02]; p = 0.04) and improvement in managing oppositional/aggressive behavior (0.02 [0.01]; p = 0.02). Role overload strengthened the positive effect of DOCC on PCP-perceived improvement in managing attention-deficit hyperactivity disorder (0.03 [0.01]; p = 0.01). Stressful climates did not influence perceptions for EUC providers.
CONCLUSIONS


Providers experiencing more stressful practice climates developed more positive perceptions of collaborative care. This may encourage stressed providers to make effective practice changes and promote practice integration of BH services.",2019,Role overload strengthened the positive effect of DOCC on PCP-perceived improvement in managing attention-deficit hyperactivity disorder (0.03 [0.01]; p = 0.01).,"['Pediatric Primary Care', '8 pediatric primary care practices to Doctor-Office Collaborative Care (DOCC), where an on-site care manager delivered BH services in coordination with PCPs, or Enhanced Usual Care (EUC), where a care manager facilitated referrals to local BH providers']",['Stressful Climates'],"['stressful climates, role conflict and role overload', 'managing attention-deficit hyperactivity disorder', 'satisfaction with practice, burdens and beliefs regarding psychosocial problems, and effectiveness in treating behavioral problems', 'managing oppositional/aggressive behavior']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031834', 'cui_str': ""Physicians' Offices""}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0008946', 'cui_str': 'Climate'}]","[{'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}]",,0.0462052,Role overload strengthened the positive effect of DOCC on PCP-perceived improvement in managing attention-deficit hyperactivity disorder (0.03 [0.01]; p = 0.01).,"[{'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Hsiung', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'Western Psychiatric Hospital, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Kelleher', 'Affiliation': ""Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kolko', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000712']
692,31129092,2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.,"OBJECTIVES


The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent.
BACKGROUND


The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial.
METHODS


The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization.
RESULTS


At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34).
CONCLUSIONS


The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.",2019,Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent.,"['1,653 patients']","['Firehawk stent', 'Firehawk or the XIENCE stent', 'Firehawk stent, a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE', 'Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent']","['late definite or probable stent thrombosis', 'safety and efficacy profiles', 'target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization', 'TLF', 'incidence of target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1653.0,0.1022,Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent.,"[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Centre for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Roskilde University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': 'Shanghai MicroPort Medical (Group) Co., Ltd., Shanghai, China.'}, {'ForeName': 'Marie-Angèle', 'Initials': 'MA', 'LastName': 'Morel', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': 'Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Amsterdam Department of Interventional Cardiolody, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Johnson', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Vlachojannis', 'Affiliation': 'Division Heart and Lungs, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Karin E', 'Initials': 'KE', 'LastName': 'Arkenbout', 'Affiliation': 'Department of Cardiology, Tergooi Ziekenhuis, Blaricum, the Netherlands.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Heart Centre, Imelda Ziekenhuis, Bonheiden, Belgium.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Ochala', 'Affiliation': 'Department of Invasive Cardiology, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Christoph K', 'Initials': 'CK', 'LastName': 'Naber', 'Affiliation': 'Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus, Essen, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Department of Cardiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Rittger', 'Affiliation': 'Medizinische Klinik I, Klinikum Fürth, University of Erlangen, Fürth, Germany.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Berti', 'Affiliation': 'UOC Cardiologia Diagnostica ed Interventistica, Fondazione C.N.R. Reg. Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Research Centre Aalst, OLV Hospital, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Gabor G', 'Initials': 'GG', 'LastName': 'Toth', 'Affiliation': 'Department of Cardiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Maillard', 'Affiliation': 'Service de Cardiologie, Clinique Axium, Aix-en-Provence, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Valina', 'Affiliation': 'Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Katowice, Poland.'}, {'ForeName': 'Holge', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Herzzentrum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Medizinische Klinik I, Herz-Thorax Zentrum, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Lansky', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut; Barts Heart Centre, London and Queen Mary University of London, London, United Kingdom. Electronic address: alexandra.lansky@yale.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, University College Hospital Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.05.001']
693,31176540,Protective effect of PCV vaccine against experimental pneumococcal challenge in adults is primarily mediated by controlling colonisation density.,"Widespread use of Pneumococcal Conjugate Vaccines (PCV) has reduced vaccine-type nasopharyngeal colonisation and invasive pneumococcal disease. In a double-blind, randomised controlled trial using the Experimental Human Pneumococcal Challenge (EHPC) model, PCV-13 (Prevenar-13) conferred 78% protection against colonisation acquisition and reduced bacterial intensity (AUC) as measured by classical culture. We used a multiplex qPCR assay targeting lytA and pneumococcal serotype 6A/B cpsA genes to re-assess the colonisation status of the same volunteers. Increase in detection of low-density colonisation resulted in reduced PCV efficacy against colonisation acquisition (29%), compared to classical culture (83%). For experimentally colonised volunteers, PCV had a pronounced effect on decreasing colonisation density. These results obtained in adults suggest that the success of PCV vaccination could primarily be mediated by the control of colonisation density. Studies assessing the impact of pneumococcal vaccines should allow for density measurements in their design.",2019,"Increase in detection of low-density colonisation resulted in reduced PCV efficacy against colonisation acquisition (29%), compared to classical culture (83%).",[],"['multiplex qPCR assay targeting lytA and pneumococcal serotype 6A/B cpsA', 'PCV vaccine', 'Pneumococcal Conjugate Vaccines (PCV', 'Experimental Human Pneumococcal Challenge (EHPC) model, PCV-13 (Prevenar-13']","['colonisation density', 'PCV efficacy against colonisation acquisition', 'bacterial intensity (AUC']",[],"[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.128852,"Increase in detection of low-density colonisation resulted in reduced PCV efficacy against colonisation acquisition (29%), compared to classical culture (83%).","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'German', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Esther.German@lstmed.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solórzano', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Carla.SolorzanoGonzalez@lstmed.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sunny', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: syba.sunny@rlbuht.nhs.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dunne', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: f.j.dunne@bham.ac.uk.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Gritzfeld', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: j.gritzfeld@liverpool.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mitsi', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Elena.Mitsi@lstmed.ac.uk.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nikolaou', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Elissavet.Nikolaou@lstmed.ac.uk.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Hyder-Wright', 'Affiliation': 'Royal Liverpool University Hospital, Liverpool, United Kingdom. Electronic address: Angela.Hyder-Wright@lstmed.ac.uk.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Collins', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Andrea.Collins@lstmed.ac.uk.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: sgordon@mlw.mw.'}, {'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, United Kingdom. Electronic address: Daniela.Ferreira@lstmed.ac.uk.'}]",Vaccine,['10.1016/j.vaccine.2019.05.080']
694,32410152,Letter to the Editor Re: Sera of Obese Type 2 Diabetic Patients Undergoing Metabolic Surgery Instead of Conventional Treatment Exert Beneficial Effects on Beta Cell Survival and Function: Results of a Randomized Clinical Study.,,2020,,['Sera of Obese Type 2 Diabetic Patients Undergoing'],"['Metabolic Surgery', 'Letter to the Editor Re']",['Beta Cell Survival and Function'],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}]","[{'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.0341806,,"[{'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Pories', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA. poriesw@ecu.edu.'}, {'ForeName': 'G Lynis', 'Initials': 'GL', 'LastName': 'Dohm', 'Affiliation': 'Department of Surgery, Brody School of Medicine, East Carolina University, 600 Moye Blvd, Greenville, NC, 27834, USA.'}]",Obesity surgery,['10.1007/s11695-020-04665-3']
695,31145173,The Effect of Depth of Anesthesia on Hemodynamic Changes Induced by Therapeutic Compression of the Trigeminal Ganglion.,"BACKGROUND


Percutaneous compression of the trigeminal ganglion (PCTG) has been used to treat trigeminal neuralgia since 1983. A PCTG-related trigeminocardiac reflex (TCR) can induce dramatic hemodynamic disturbances. This study investigates the effects of depth of propofol anesthesia on hemodynamic changes during PCTG.
MATERIALS AND METHODS


A total of 120 patients who underwent PTCG for trigeminal neuralgia were randomly assigned to control group-intravenous saline pretreatment before PCTG puncture and anesthesia targeted to bispectral index (BIS) 40 to 60 throughout, and study group-intravenous propofol 1 to 2 mg/kg pretreatment to deepen anesthesia to BIS<40 before PCTG. Mean arterial pressure, heart rate (HR), cardiac output, system vascular resistance, and BIS were measured at 9 time points during the procedure, and the incidence of the TCR was observed at T5 and T6.
RESULTS


BIS was lower in the study group compared with the control after pretreatment with propofol or saline, respectively. Compared with the control group, mean arterial pressure was lower in the study group at several points during the procedure, but there was no difference in HR between the 2 groups at any point. Cardiac output was higher and system vascular resistance lower in the study compared with the control group. In the control group, 42 (70.0%) and 52 (86.7%) of patients developed a TCR at the 2 points, and 37 (67.1%) and 45 (75.0%) in the study group. There was no difference in the incidence of TCR between the 2 groups.
CONCLUSION


Increasing the depth of propofol anesthesia partially attenuated PTCG-related elevation of blood pressure but did not modify the abrupt reduction in HR.",2020,Increasing the depth of propofol anesthesia partially attenuated PTCG-related elevation of blood pressure but did not modify the abrupt reduction in HR.,['120 patients who underwent PTCG for trigeminal neuralgia'],"['propofol anesthesia', 'control group-intravenous saline pretreatment before PCTG puncture and anesthesia targeted to bispectral index (BIS) 40 to 60 throughout, and study group-intravenous propofol 1 to 2\u2009mg/kg pretreatment to deepen anesthesia to BIS<40 before PCTG', 'Percutaneous compression of the trigeminal ganglion (PCTG', 'propofol']","['incidence of the TCR', 'blood pressure', 'Cardiac output', 'BIS', 'incidence of TCR', 'HR', 'Mean arterial pressure, heart rate (HR), cardiac output, system vascular resistance, and BIS', 'hemodynamic changes', 'mean arterial pressure']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040997', 'cui_str': 'Fothergill Disease'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0040995', 'cui_str': 'Semilunar Ganglion'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",120.0,0.0364491,Increasing the depth of propofol anesthesia partially attenuated PTCG-related elevation of blood pressure but did not modify the abrupt reduction in HR.,"[{'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesiology, Shengjing Hospital of China Medical University.'}, {'ForeName': 'Zhan-Ying', 'Initials': 'ZY', 'LastName': 'Guan', 'Affiliation': 'Department of Anesthesiology, Branch Hospital of Hunan, The General Hospital of Shenyang Military Region.'}, {'ForeName': 'Quan-Cai', 'Initials': 'QC', 'LastName': 'Wang', 'Affiliation': ""Second Department of Neurosurgery, People's Hospital of China Medical University (Liaoning Provincial People's Hospital), Shenyang, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, People's Hospital of China Medical University (Liaoning Provincial People's Hospital).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Second Department of Neurosurgery, People's Hospital of China Medical University (Liaoning Provincial People's Hospital), Shenyang, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anaesthesiology, Shengjing Hospital of China Medical University.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000612']
696,30664702,Anemia is an independent risk factor for cardiovascular and renal events in hypertensive outpatients with well-controlled blood pressure: a subgroup analysis of the ATTEMPT-CVD randomized trial.,"To investigate whether anemia is an independent risk factor for cardiovascular and renal events in hypertensive outpatients, we performed a subgroup analysis of the ATTEMPT-CVD study based on baseline hemoglobin. The ATTEMPT-CVD study was a multicenter, prospective, randomized study of hypertensive outpatients that compared the efficacy of angiotensin receptor blocker (ARB)-based antihypertensive treatment with non-ARB antihypertensive treatment over 3 years. In the present subanalysis, ATTEMPT-CVD study participants (n = 1213) were categorized into the anemic group and nonanemic group according to their baseline hemoglobin. We compared the anemic and nonanemic groups mainly in regard to the incidence of cardiovascular and renal events and blood pressure. We also performed a multivariable Cox proportional hazards analysis to determine the prognostic factors that were independently associated with cardiovascular and renal events. Of the 1213 patients enrolled in the ATTEMPT-CVD, 194 patients had anemia (mostly mild anemia) and 1019 patients did not. Blood pressure was well-controlled during the 3 years of antihypertensive therapy in both the anemic and nonanemic groups. However, the incidence of cardiovascular and renal events was significantly greater in the anemic group than in the nonanemic group (HR = 1.945: 95%CI 1.208-3.130; P = 0.0062). Even after adjustment, anemia was independently associated with cardiovascular and renal events (HR = 1.816: 95%CI 1.116-2.955; P = 0.0163) in overall hypertensive patients with well-controlled blood pressure. Anemia, even mild anemia, is an independent risk factor for cardiovascular and renal events in hypertensive outpatients whose blood pressure is well-controlled. Thus, anemia may be a novel therapeutic target for cardiovascular and renal diseases in hypertensive outpatients with anemia.",2019,"Anemia, even mild anemia, is an independent risk factor for cardiovascular and renal events in hypertensive outpatients whose blood pressure is well-controlled.","['hypertensive outpatients with anemia', 'hypertensive outpatients with well-controlled blood pressure', 'hypertensive outpatients', '1213 patients enrolled in the ATTEMPT-CVD, 194 patients had anemia (mostly mild anemia) and 1019 patients did not', 'participants (n\u2009=\u20091213) were categorized into the anemic group and nonanemic group according to their baseline hemoglobin']",['angiotensin receptor blocker (ARB)-based antihypertensive treatment with non-ARB antihypertensive treatment'],"['Blood pressure', 'incidence of cardiovascular and renal events', 'incidence of cardiovascular and renal events and blood pressure', 'cardiovascular and renal events']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1264693', 'cui_str': 'Arbitrary'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1213.0,0.0258605,"Anemia, even mild anemia, is an independent risk factor for cardiovascular and renal events in hypertensive outpatients whose blood pressure is well-controlled.","[{'ForeName': 'Shokei', 'Initials': 'S', 'LastName': 'Kim-Mitsuyama', 'Affiliation': 'Department of Pharmacology and Molecular Therapeutics, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. mitsuyam@gpo.kumamoto-u.ac.jp.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yasuda', 'Affiliation': 'Department of Sports and Life Sciences, National Institute of Fitness and Sports in Kanoya, Kanoya, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Node', 'Affiliation': 'Department of Cardiovascular Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Diabetes Care Center, Jinnouchi Clinic, Kumamoto, Japan.'}, {'ForeName': 'Eiichiro', 'Initials': 'E', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Sekigami', 'Affiliation': 'Division of Internal Medicine & Diabetes and Endocrine, Sekigami Clinic, Yatsushiro, Japan.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Department of General and Community Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0210-1']
697,31644921,Effect of community-based lifestyle interventions on weight loss and cardiometabolic risk factors in obese elderly in China: A randomized controlled trial.,"PURPOSE


We aimed to assess the effect of community-based lifestyle interventions on weight loss and cardiometabolic risk factors among obese older adults, and to explore the potential factors that impede weight loss during lifestyle interventions.
MATERIALS AND METHODS


A 2-arm parallel randomized controlled trial was conducted from 2013 through 2016 in the community health service centers in Nanjing, China. Four hundred and eighty obese older adults were randomly assigned to receive a 24-month lifestyle intervention (242 participants) or usual care (238 participants). The intervention group received a community-based behavioral lifestyle intervention program, which targeted weight loss through dietary changes and increased physical activity, with a combination mode of intervention delivery.
RESULTS


Weight loss was statistically significant at the end of the intervention with a mean reduction of 0.03 ± 2.51 kg in the control group and 3.22 ± 3.43 kg in the intervention group (p < .001). In the intervention group, 41.1% of participants achieved the target of 5% weight loss significantly (p < .001). Participants in the intervention group had significantly greater improvements in cardiometabolic risk factors. Multivariable logistic regression showed that female, living alone, and having more comorbidities were barriers to weight loss during the intervention.
CONCLUSIONS


This study demonstrated that community-based lifestyle interventions are effective for managing weight and improving cardiometabolic risk factors in obese older adults.",2019,"In the intervention group, 41.1% of participants achieved the target of 5% weight loss significantly (p < .001).","['242 participants) or usual care (238 participants', 'obese older adults', '2013 through 2016 in the community health service centers in Nanjing, China', 'Four hundred and eighty obese older adults', 'obese elderly in China']","['community-based behavioral lifestyle intervention program', '24-month lifestyle intervention', 'community-based lifestyle interventions']","['cardiometabolic risk factors', 'weight loss and cardiometabolic risk factors', 'target of 5% weight loss', 'Weight loss']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009472', 'cui_str': 'Community Health Services'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",480.0,0.0506889,"In the intervention group, 41.1% of participants achieved the target of 5% weight loss significantly (p < .001).","[{'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianqian', 'Initials': 'J', 'LastName': 'Chao', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China. Electronic address: chao_seu@163.com.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lingyan', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yingpeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Environmental Medicine Engineering of Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.'}]",Experimental gerontology,['10.1016/j.exger.2019.110749']
698,29743322,"Protocol for a randomised controlled trial to evaluate the effectiveness of the 'Care for Stroke' intervention in India: a smartphone-enabled, carer-supported, educational intervention for management of disabilities following stroke.","INTRODUCTION


The rising prevalence of stroke and stroke-related disability witnessed globally over the past decades may cause an overwhelming demand for rehabilitation services. This situation is of concern for low-income and middle-income countries like India where the resources for rehabilitation are often limited. Recently, a smartphone-enabled carer-supported educational intervention for management of physical disabilities following stroke was developed in India. It was found to be feasible and acceptable, but evidence of effectiveness is lacking. Hence, as a step forward, this study intends to evaluate clinical effectiveness of the intervention through a randomised controlled trial.
METHODS


The objective of the study is to evaluate whether the 'Care for Stroke' intervention is clinically and cost-effective for the reduction of dependency in activities of daily living among stroke survivors in an Indian setting. This study is designed as a randomised controlled trial comparing people who received the intervention to those receiving standard care. The trial will be pragmatic and outcome assessor-blinded. The primary outcome for the study is dependency in daily living measured by the Modified Rankin Scale (MRS). A total of 266 adult stroke survivors who fulfil the eligibility criteria will be randomised to receive either 'Care for Stroke' intervention or standard treatment and will be followed up for 6 weeks. The main analyses will compare participants allocated to the 'Care for Stroke' intervention versus those allocated to the standard treatment group on an 'intention-to-treat' basis, irrespective of whether the participants received the treatment allocated or not. The dichotomised MRS scores (0-3 and 4-6) in both the groups will be used to calculate the effect estimates with a measure of precision (95% CI) and presented in the results of the trial.
ETHICS AND DISSEMINATION


The Indian Institute of Public Health-Hyderabad/Public Health Foundation of India - Independent Institutional Ethics Committee and the Ethics Committee of the London School of HygieneandTropical Medicine. Dissemination will be through peer-reviewed publications.
TRIAL REGISTRATION NUMBER


Clinical Trial Registry of India CTRI/2017/07/009014.",2018,"Recently, a smartphone-enabled carer-supported educational intervention for management of physical disabilities following stroke was developed in India.","['266 adult stroke survivors who fulfil the eligibility criteria', 'people who received the intervention to those receiving standard care', 'stroke survivors in an Indian setting']","['smartphone-enabled carer-supported educational intervention', ""Care for Stroke' intervention or standard treatment and will be followed up for 6\u2009weeks"", 'smartphone-enabled, carer-supported, educational intervention']","['dependency in daily living measured by the Modified Rankin Scale (MRS', 'dichotomised MRS scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C1276367', 'cui_str': 'Carer support'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",266.0,0.1993,"Recently, a smartphone-enabled carer-supported educational intervention for management of physical disabilities following stroke was developed in India.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sureshkumar', 'Affiliation': 'Public Health Foundation of India, Indian institute of Public Health - Hyderabad, South Asia Centre for Disability, Inclusive Development and Research (SACDIR), Hyderabad, Telangana, India.'}, {'ForeName': 'G V S', 'Initials': 'GVS', 'LastName': 'Murthy', 'Affiliation': 'Public Health Foundation of India, Indian institute of Public Health - Hyderabad, South Asia Centre for Disability, Inclusive Development and Research (SACDIR), Hyderabad, Telangana, India.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Kuper', 'Affiliation': 'Department of Clinical Research, International Centre for Evidence in Disability, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2017-020098']
699,32492105,A Randomized Trial of Convalescent Plasma for COVID-19-Potentially Hopeful Signals.,,2020,,[],[],[],[],[],[],,0.04554,,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Casadevall', 'Affiliation': 'Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Joyner', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Liise-Anne', 'Initials': 'LA', 'LastName': 'Pirofski', 'Affiliation': 'Montefiore Medical Center, Division of Infectious Diseases, Department of Medicine, Albert Einstein College of Medicine, Bronx, New York.'}]",JAMA,['10.1001/jama.2020.10218']
700,31103365,Therapeutic HSV-2 vaccine decreases recurrent virus shedding and recurrent genital herpes disease.,"BACKGROUND


Genital herpes simplex virus (HSV) type 2 is a common persistent infection that frequently reactivates to cause recurrent lesions and recurrent viral shedding which is incompletely controlled by antiviral therapy. GEN-003 is a candidate therapeutic vaccine containing 2 HSV-2 proteins, gD2 and ICP4, and Matrix-M2 adjuvant (M2).
METHODS


HSV-2 seropositive persons with genital herpes were randomized into three dose cohorts of Gen-003 (60 µg antigen/50 µg M2, 60 µg/75 µg M2 or Placebo). Three intramuscular doses 21 days apart of GEN-003 or placebo were administered. Participants obtained genital area swabs twice-daily for HSV-2 detection and monitored genital lesions for 12 months. The rates of virus shedding and lesion rates before vaccination were compared to 3 defined periods after vaccination; Days 43-71, Month 6 and Month 12.
RESULTS


GEN-003 at a dose of 60 µg each antigen/50 µg M2 reduced HSV shedding immediately after dosing with a rate ratio of 0.58, compared to 0.75 for the GEN-003 60 µg/75 µg M2 and 1.06 for placebo. Lesion rates, recurrence rates, and duration of recurrences were also reduced. Reactogenicity was higher with the 75 µg M2 dose than the 50 µg M2 dose, specifically for pain, tenderness, malaise and fatigue. Antibody and cellular immune responses were stimulated by both doses and persisted to 12 months.
CONCLUSIONS


GEN-003 vaccine manufactured with a scalable process gave results similar to those observed in prior clinical trials. GEN-003 had an acceptable safety profile and stimulated both humoral and cellular immune responses. The 60 µg antigen/50 µg M2 provided the maximal effect on virologic and clinical measures and warrants further development. (Funded by Genocea; ClinicalTrials.gov number NCT02515175).",2019,"Reactogenicity was higher with the 75 µg M2 dose than the 50 µg M2 dose, specifically for pain, tenderness, malaise and fatigue.",['HSV-2 seropositive persons with genital herpes'],"['placebo', 'Gen-003 (60\u202fµg antigen/50\u202fµg\u202fM2, 60\u202fµg/75\u202fµg\u202fM2 or Placebo', 'GEN-003', 'GEN-003 or placebo', 'Therapeutic HSV-2 vaccine']","['Lesion rates, recurrence rates, and duration of recurrences', 'rates of virus shedding and lesion rates', 'Reactogenicity', 'Antibody and cellular immune responses', 'pain, tenderness, malaise and fatigue']","[{'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019342', 'cui_str': 'Herpes Simplex Virus Genital Infection'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019351', 'cui_str': 'Human Herpesvirus 2'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0024528', 'cui_str': 'Malaise and fatigue (finding)'}]",,0.0722721,"Reactogenicity was higher with the 75 µg M2 dose than the 50 µg M2 dose, specifically for pain, tenderness, malaise and fatigue.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Cincinnati Children's Hospital Medzical Center, University of Cincinnati, Cincinnati, OH, USA. Electronic address: david.bernstein@cchmc.org.""}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'Flechtner', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'McNeil', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heineman', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Oliphant', 'Affiliation': 'Innovative Analytics, Kalamazoo, MI, USA.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Tasker', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Hetherington', 'Affiliation': 'Genocea Biosciences, Cambridge, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.05.009']
701,31103367,Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings.,"OBJECTIVE


To test the effectiveness of a multimodal intervention in obstetrics/gynecology (ob-gyn) clinics to increase uptake of influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccines in pregnant women and these vaccines plus human papillomavirus (HPV) vaccine in non-pregnant women.
METHODS


A cluster randomized controlled trial among 9 private ob-gyn practices in Colorado from 9/2011 to 5/2014. The intervention consisted of: designation of immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials. Control practices continued usual care. Primary outcomes were receipt of influenza and Tdap vaccines among pregnant women and these vaccines plus HPV vaccine among non-pregnant women, comparing a Baseline period (Year 0/Year 1) to Year 2, intervention versus control. With an estimated sample size of 32,590 per arm, there would be >80% power to detect a 10% difference between groups.
RESULTS


In the Baseline period, 27% of pregnant women in both intervention and control practices received influenza vaccine. In Year 2, 29% of pregnant women in intervention practices received influenza vaccine versus 41% in control practices. In the Baseline period, 18% of pregnant women in intervention practices received Tdap vaccine versus 22% in control practices. Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations. Relatively few HPV, influenza or Tdap vaccines (≤6% of eligible patients) were given to non-pregnant patients in either intervention or control practices at any time during the study.
CONCLUSION


In this cluster randomized trial designed to increase vaccination uptake, both intervention and control practices showed improved vaccination of pregnant but not non-pregnant patients. Future work should focus on tailoring evidence-based immunization practices or developing new approaches to specifically fit busy ob-gyn offices.",2019,"Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations.","['pregnant women and these', 'obstetrics/gynecology settings', 'non-pregnant women', 'pregnant but not non-pregnant patients', '9 private ob-gyn practices in Colorado from 9/2011 to 5/2014']","['Tdap vaccines', 'Tdap vaccine', 'vaccines plus human papillomavirus (HPV) vaccine', 'immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials', 'diphtheria-acellular pertussis (Tdap) vaccines', 'influenza vaccine', 'multimodal intervention']",['receipt of influenza and Tdap vaccines'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4277736', 'cui_str': 'Standing Orders'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",9.0,0.0895034,"Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations.","[{'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Pediatrics, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA. Electronic address: sean.oleary@ucdenver.edu.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Brewer', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Miriam Dickinson', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Family Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Pediatrics, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}]",Vaccine,['10.1016/j.vaccine.2019.05.034']
702,29972085,Non-strategic ignorance: Considering the potential for a paradigm shift in evidence-based mental health.,"Randomised controlled trials form a central building block within the prevailing evidence-based mental health paradigm. Both methodology and paradigm have been widely problematised since their emergence in the mid-late twentieth century. We draw on the concept of 'strategic ignorance' to understand why the paradigm still prevails. We present focus group data gathered from 37 participants (service users, public, carers, general practitioners, commissioners) concerning the way they made sense of a randomised controlled trial of psychotherapy for treatment-resistant depression. Thematic analysis of the findings revealed an overall critique of randomised controlled trial methods which we refer to as 'non-strategic ignorance'. Specifically, participants problematised the construct of depression, unseating the premise of the randomised controlled trial; they were sceptical about the purpose and highlighted its failure to show how therapy works or who might benefit; the randomised controlled trial was seen as inadequate for informing decisions about how to select a therapy. Participants assumed the treatment would be cost-effective given the client group and nature of the therapy, irrespective of any randomised controlled trial findings. Each area of lay ('non-strategic') critique has an analogous form within the methodological expert domain. We argue that 'expert' critiques have generally failed to have paradigmatic impact because they represent strategic ignorance. Yet parallel non-strategic critiques have common sense appeal, highlighting the potential power of lay voices. The discussion considers whether the evidence-based mental health paradigm is faced with epistemological problems of such complexity that the conditions exist for a new paradigm in which service user views are central and randomised controlled trials peripheral.",2020,Both methodology and paradigm have been widely problematised since their emergence in the mid-late twentieth century.,"['Non-strategic ignorance', '37 participants (service users, public, carers, general practitioners, commissioners']",['psychotherapy'],[],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],37.0,0.282929,Both methodology and paradigm have been widely problematised since their emergence in the mid-late twentieth century.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'University of Essex, UK.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Rost', 'Affiliation': 'The Tavistock and Portman NHS Foundation Trust, UK.'}, {'ForeName': 'Sukhjit', 'Initials': 'S', 'LastName': 'Sidhu', 'Affiliation': 'University of Essex, UK.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'The Tavistock and Portman NHS Foundation Trust, UK.'}]","Health (London, England : 1997)",['10.1177/1363459318785720']
703,31072087,Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Polydeoxyribonucleotide in the Treatment of Knee Osteoarthritis.,"OBJECTIVE


To assess the clinical efficacy and safety of intra-articular injection of hyaluronic acid (HA) combined with polydeoxyribonucleotide (PDRN) in patients with knee osteoarthritis in comparison with that of HA alone.
METHODS


The current single-center, prospective, randomized, double-blind, controlled study was conducted in 36 patients with knee osteoarthritis at our medical institution. All the eligible patients (n=30) were equally assigned to two treatment arms (trial group 'HA+PDRN' and control group 'HA'). For efficacy assessment, the patients were evaluated for the visual analogue scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Society Scores (KSS), all of which served as efficacy outcome measures. We monitored time-dependent changes in efficacy outcome measures at baseline and 1, 3 and 6 months. Subsequently, we compared differences in changes in efficacy outcome measures at 6 months from baseline between the two groups. Moreover, we assessed the safety based on the treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs) and any other complications serving as safety outcome measures.
RESULTS


There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except 'Stiffness', the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05). In our series, there were no TEAEs, ADRs, and any other complications.
CONCLUSION


Intra-articular injections of HA combined with PDRN can also be considered in the treatment of knee osteoarthritis. However, further large-scale and multi-center studies are required to demonstrate the potential of the proposed combination.",2019,"There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except 'Stiffness', the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05).","['Knee Osteoarthritis', 'patients with knee osteoarthritis in comparison with that of HA alone', 'eligible patients (n=30', '36 patients with knee osteoarthritis at our medical institution']","[""HA+PDRN' and control group 'HA"", 'hyaluronic acid (HA) combined with polydeoxyribonucleotide (PDRN', 'Hyaluronic Acid Combined With Polydeoxyribonucleotide', 'HA combined with PDRN']","['visual analogue scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Society Scores (KSS', 'safety based on the treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs) and any other complications serving as safety outcome measures', 'VAS scores, the WOMAC scores', 'total WOMAC scores, and the KSS scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032468', 'cui_str': 'Polydeoxyribonucleotides'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",36.0,0.0490441,"There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except 'Stiffness', the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05).","[{'ForeName': 'Seihee', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Jung Joong', 'Initials': 'JJ', 'LastName': 'Kang', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Jungin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Seunghun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Jong Moon', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.2019.43.2.204']
704,31740271,"The effects of nalmefene on emotion processing in alcohol use disorder - A randomized, controlled fMRI study.","Nalmefene is a µ- and δ-opioid receptor antagonist and a partial κ-opioid receptor agonist. The drug is suggested to reduce the craving for, and the consumption of alcohol effectively, also alleviating anxiety and anhedonia. The present fMRI study is the first to investigate the processing of emotions as a possible mechanism of action of nalmefene in humans. Fifteen non-treatment-seeking participants suffering from alcohol use disorder (AUD) (24-66 years; 5 females) finished this randomized, placebo controlled, double blind study. Following a cross over design, participants received either a single dose nalmefene or a placebo, with an interval of one week between sessions. Using fMRI, we investigated neural reactivity during the presentation of emotional faces picture sets. Additionally, we performed a visual dot-probe task to detect nalmefene's effects on attentional bias. We detected an increase in the response to emotional faces in the supramarginal gyrus, the angular gyrus as well as the putamen in the nalmefene vs. placebo condition. However, contradictory to our initial hypotheses, amygdala activation was not altered significantly in the placebo condition - a limitation, which might be associated with a lack of activation in the placebo condition maybe due to the small sample size. Attentional bias analyses revealed an interaction effect by trend, which was driven by a significant effect in a sub-analysis showing increased attentional shift towards happy compared to fearful facial expressions under nalmefene. Nalmefene increased brain activation in areas responsible for empathy, social cognition and behavior, which might help alleviating the reinforcing properties of alcohol.",2019,"We detected an increase in the response to emotional faces in the supramarginal gyrus, the angular gyrus as well as the putamen in the nalmefene vs. placebo condition.",['Fifteen non-treatment-seeking participants suffering from alcohol use disorder (AUD) (24-66 years; 5 females'],"['nalmefene', 'placebo']","['attentional shift towards happy', 'emotion processing', 'brain activation', 'response to emotional faces', 'attentional bias']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0068377', 'cui_str': 'nalmefene'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}]",,0.118707,"We detected an increase in the response to emotional faces in the supramarginal gyrus, the angular gyrus as well as the putamen in the nalmefene vs. placebo condition.","[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Vollstädt-Klein', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany. Electronic address: s.vollstaedt-klein@zi-mannheim.de.'}, {'ForeName': 'J Malte', 'Initials': 'JM', 'LastName': 'Bumb', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Otto', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dinter', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Karl', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Koopmann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}, {'ForeName': 'Derik', 'Initials': 'D', 'LastName': 'Hermann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Mann', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany.'}, {'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Kiefer', 'Affiliation': 'Department of Addictive Behavior and Addiction Medicine, Central Institute of Mental Health, Medical Faculty Mannheim/Heidelberg University, Square J5, D-68159 Mannheim, Germany; Feuerlein Center on Translational Addiction Medicine (FCTS), University of Heidelberg, Germany.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2019.10.014']
705,31043521,A phase 2 clinical trial of a vasopressin V1a receptor antagonist shows improved adaptive behaviors in men with autism spectrum disorder.,"There are no approved pharmacological therapies to address the core symptoms of autism spectrum disorder (ASD), namely, persistent deficits in social communication and social interaction and the presence of restricted, repetitive patterns of behaviors, interests, or activities. The neuropeptide vasopressin has been implicated in the regulation of social behaviors, and its modulation has emerged as a therapeutic target for ASD. The phase 2 VANILLA clinical trial reported here evaluated balovaptan, an orally administered selective vasopressin V1a receptor antagonist, in 223 men with ASD and intelligence quotient ≥70. The drug was administered daily for 12 weeks and was compared with placebo. Participants were randomized to placebo ( n  = 75) or one of three balovaptan dose arms (1.5 mg,  n  = 32; 4 mg,  n  = 77; 10 mg,  n  = 39). Balovaptan treatment was not associated with a change from baseline compared with placebo at 12 weeks in the primary efficacy endpoint (Social Responsiveness Scale, 2nd Edition). However, dose-dependent and clinically meaningful improvements on the Vineland-II Adaptive Behavior Scales composite score were observed for participants treated with balovaptan 4 or 10 mg compared with placebo. This was driven principally by improvements in the Vineland-II socialization and communication scores. Balovaptan was well tolerated across all doses, and no drug-related safety concerns were identified. These results support further study of balovaptan as a potential treatment for the socialization and communication deficits in ASD.",2019,"Balovaptan treatment was not associated with a change from baseline compared with placebo at 12 weeks in the primary efficacy endpoint (Social Responsiveness Scale, 2nd Edition).","['men with autism spectrum disorder', '223 men with ASD and intelligence quotient ≥70']","['balovaptan', 'placebo', 'Balovaptan', 'selective vasopressin V1a receptor antagonist', 'neuropeptide vasopressin', 'vasopressin V1a receptor antagonist']","['Vineland-II Adaptive Behavior Scales composite score', 'efficacy endpoint (Social Responsiveness Scale, 2nd Edition', 'adaptive behaviors']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient (observable entity)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0284725', 'cui_str': 'Vasopressin Type 1A Receptor'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}]","[{'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0222045'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}]",223.0,0.105261,"Balovaptan treatment was not associated with a change from baseline compared with placebo at 12 weeks in the primary efficacy endpoint (Social Responsiveness Scale, 2nd Edition).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bolognani', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Valle Rubido', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Squassante', 'Affiliation': 'Product Development, F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'Product Development, F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Derks', 'Affiliation': 'Roche Pharma Research and Early Development, Roche Innovation Center Welwyn, Roche Products Ltd., Welwyn, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Murtagh', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sevigny', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khwaja', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Umbricht', 'Affiliation': 'Neuroscience, Ophthalmology, and Rare Diseases (NORD), Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Fontoura', 'Affiliation': 'Product Development, F. Hoffmann-La Roche AG, Basel, Switzerland. paulo.fontoura@roche.com.'}]",Science translational medicine,['10.1126/scitranslmed.aat7838']
706,31079163,Three days of training with a low-fidelity arthroscopy triangulation simulator box improves task performance in a virtual reality high-fidelity virtual knee arthroscopy simulator.,"PURPOSE


The aim of this work is to evaluate the effectiveness of training with the low-fidelity ArthroBox ®  regarding performance of different basic arthroscopy tasks using a validated high-fidelity virtual reality simulator of the knee.
METHODS


Nineteen volunteers (14 females and 5 males) without any previous experience in arthroscopy were randomly assigned either to the ArthroBox ®  training group (n =10) or the non-training group (n =9). The training group underwent a supervised ArthroBox  ®  training consisting of a daily 60-min session for three consecutive days. Both groups completed the basic and the final assessment using a validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™). The following three factors were measured in different exercises (explained in ""Materials and methods""): amount of time to finish the task, length of camera and scope path within the joint. Furthermore, the volunteers' demographics (age, sex, dexterity, video game experience, sport activities and profession) was assessed but showed no differences between the groups.
RESULTS


There were no significant differences between the training and non-training group regarding the above-mentioned demographic factors. However, the training group showed significant improvement from baseline to follow-up in most activities (e.g. task performance time in seconds, intra-articular camera and grasp distance in centimetres; see Table 1) in comparison to the non-training group.
CONCLUSIONS


The results from this study demonstrate that training for three consecutive days using a portable and versatile low-fidelity simulator significantly improves arthroscopy performance when using a validated high-fidelity virtual knee simulator. Arthroscopic triangulation training outside the operating theatre with a portable, low-cost simulator has proven to be a valuable educational tool to improve the arthroscopic skills of trainee surgeons.
LEVEL OF EVIDENCE


Diagnostic study, Level II.",2020,"Both groups completed the basic and the final assessment using a validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™).","['Nineteen volunteers (14 females and 5 males) without any previous experience in arthroscopy', 'virtual reality high-fidelity virtual knee arthroscopy simulator']","['validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™', 'ArthroBox ®  training group (n\u2009=10) or the non-training group']","['arthroscopy performance', 'most activities (e.g. task performance time in seconds, intra-articular camera and grasp distance', 'task performance']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",19.0,0.0404162,"Both groups completed the basic and the final assessment using a validated virtual reality-based passive haptic knee arthroscopy simulator (ArthroS, VirtaMed™).","[{'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Bouaicha', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland. samy.bouaicha@balgrist.ch.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Epprecht', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Jentzsch', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Ernstbrunner', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Rany', 'Initials': 'R', 'LastName': 'El Nashar', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rahm', 'Affiliation': 'Department of Orthopedics, Balgrist University Hospital, University of Zurich, Forchstrasse 340, 8008, Zurich, Switzerland.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-019-05526-y']
707,31076307,Combined Approach Versus 2 Conventional Approaches in Ultrasound-Guided Central Venous Catheterization: A Randomized Controlled Trial.,"OBJECTIVE


The authors compared the occurrence of posterior wall puncture using the short-axis out-of-plane and long-axis in-plane approaches with that using the combined short-axis-and-long-axis approach that the authors previously showed to be effective in observational and manikin studies.
DESIGN


Randomized controlled study.
SETTING


Single tertiary institution.
PARTICIPANTS


One hundred twenty patients who underwent cardiac or vascular surgery under general anesthesia.
INTERVENTIONS


The patients were divided randomly into combined short-axis-and-long-axis (n = 40), short-axis out-of-plane (SA-OOP) (n = 40), and long-axis in-plane (LA-IP) (n = 40) groups and received ultrasound-guided central venous catheterization at the right internal jugular vein.
MEASUREMENTS AND MAIN RESULTS


Successful guidewire insertion without posterior wall puncture was performed in 40 patients (100%) in the combined short-axis-and-long-axis approach group, 28 (70%) in the short-axis out-of-plane approach group, and 38 (95%) in the LA-IP approach group (combined short-axis-and-long-axis v SA-OOP, p = 0.0002 [relative risk = 1.43; 95% CI: 1.17-1.75]; combined short-axis-and-long-axis v LA-IP, p = 0.49 [relative risk = 1.05; 95% CI: 0.98-1.13]). Procedure durations were 28.5 (24.1-36.4) seconds in the combined short-axis-and-long-axis group, 31.7 (24.4-40.6) seconds in the SA-OOP group, and 24.3 (20.8-32.1) seconds in the long-axis in-plane group (combined short-axis-and-long-axis v SA-OOP, p = 0.53; combined short-axis-and-long-axis v LA-IP, p = 0.044).
CONCLUSION


The combined short-axis-and-long-axis approach for ultrasound-guided central venous catheterization had a lower posterior wall puncture rate than the SA-OOP approach, but there was no significant difference with the long-axis in-plane approach.",2019,"The combined short-axis-and-long-axis approach for ultrasound-guided central venous catheterization had a lower posterior wall puncture rate than the SA-OOP approach, but there was no significant difference with the long-axis in-plane approach.","['Single tertiary institution', 'One hundred twenty patients who underwent cardiac or vascular surgery under general anesthesia']","['combined short-axis-and-long-axis (n\u202f=\u202f40), short-axis out-of-plane (SA-OOP) (n\u202f=\u202f40), and long-axis in-plane (LA-IP) (n\u202f=\u202f40) groups and received ultrasound-guided central venous catheterization at the right internal jugular vein', 'Combined Approach Versus 2 Conventional Approaches in Ultrasound-Guided Central Venous Catheterization', 'combined short-axis-and-long-axis approach for ultrasound-guided central venous catheterization']","['Procedure durations', 'Successful guidewire insertion without posterior wall puncture', 'posterior wall puncture rate']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714645', 'cui_str': 'Vascular surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0522488', 'cui_str': 'Short axis (qualifier value)'}, {'cui': 'C0522487', 'cui_str': 'Long axis (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0007435', 'cui_str': 'Central Catheterization'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442071', 'cui_str': 'Posterior wall (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",120.0,0.0460817,"The combined short-axis-and-long-axis approach for ultrasound-guided central venous catheterization had a lower posterior wall puncture rate than the SA-OOP approach, but there was no significant difference with the long-axis in-plane approach.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeshita', 'Affiliation': ""Department of Intensive Care Medicine, Osaka Prefectural Hospital Organization, Osaka Women's and Children's Hospital, Izumi, Osaka, Japan. Electronic address: t-k-s-t@koto.kpu-m.ac.jp.""}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Emergency and Critical Care Medicine, National Hospital Organization, Kyoto Medical Center, Mukaihata-cho, Fushimi-ku, Kyoto, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Fukumoto', 'Affiliation': 'Department of Cardiovascular Surgery, Rakuwakai Otowa Hospital, Yamashina-ku, Kyoto, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Shime', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Graduate School of Biomedical & Health Sciences, Hiroshima University, Minami-ku, Hiroshima, Japan.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.03.051']
708,31072710,A Pilot Randomized Controlled Study of Mild Hypercapnia During Cardiac Surgery With Cardiopulmonary Bypass.,"OBJECTIVES


To test whether targeted therapeutic mild hypercapnia (TTMH) would attenuate cerebral oxygen desaturation detected using near-infrared spectroscopy during cardiac surgery requiring cardiopulmonary bypass (CPB).
DESIGN


Randomized controlled trials.
SETTING


Operating rooms and intensive care unit of tertiary hospital.
PARTICIPANTS


The study comprised 30 patients undergoing cardiac surgery with CPB.
INTERVENTIONS


Patients were randomly assigned to receive either standard carbon dioxide management (normocapnia) or TTMH (target arterial carbon dioxide partial pressure between 50 and 55 mmHg) throughout the intraoperative period and postoperatively until the onset of spontaneous ventilation.
MEASUREMENTS AND MAIN RESULTS


Relevant biochemical and hemodynamic variables were measured, and cerebral tissue oxygen saturation (SctO 2 ) was monitored with near-infrared spectroscopy. Patients were followed-up with neuropsychological testing. Patient demographics between groups were compared using the Fisher exact and Mann-Whitney tests, and SctO 2  between groups was compared using repeated measures analysis of variance. The median patient age was 67 years (interquartile range [IQR] 62-72 y), and the median EuroSCORE II was 1.1. The median CPB time was 106 minutes. The mean intraoperative arterial carbon dioxide partial pressure for each patient was significantly higher with TTMH (52.1 mmHg [IQR 49.9-53.9 mmHg] v 40.8 mmHg [IQR 38.7-41.7 mmHg]; p < 0.001) as was pulmonary artery pressure (23.9 mmHg [IQR 22.4-25.3 mmHg] v 18.5 mmHg [IQR 14.8-20.7 mmHg]; p = 0.004). There was no difference in mean percentage change in SctO 2  during CPB in the control group for both hemispheres (left: -6.7% v -2.3%; p = 0.110; right: -7.9% v -1.0%; p = 0.120). Compliance with neuropsychological test protocols was poor. However, the proportion of patients with drops in test score >20% was similar between groups in all tests.
CONCLUSIONS


TTMH did not increase SctO 2  appreciably during CPB but increased pulmonary artery pressures before and after CPB. These findings do not support further investigation of TTMH as a means of improving SctO 2  during and after cardiac surgery requiring CPB.",2019,These findings do not support further investigation of TTMH as a means of improving SctO 2  during and after cardiac surgery requiring CPB.,"['30 patients undergoing cardiac surgery with CPB', 'Operating rooms and intensive care unit of tertiary hospital']","['Cardiac Surgery With Cardiopulmonary Bypass', 'Mild Hypercapnia', 'TTMH', 'standard carbon dioxide management (normocapnia) or TTMH (target arterial carbon dioxide partial pressure', 'targeted therapeutic mild hypercapnia (TTMH']","['pulmonary artery pressures', 'pulmonary artery pressure', 'cerebral oxygen desaturation', 'cerebral tissue oxygen saturation (SctO 2 ', 'mean intraoperative arterial carbon dioxide partial pressure', 'median CPB time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",30.0,0.157163,These findings do not support further investigation of TTMH as a means of improving SctO 2  during and after cardiac surgery requiring CPB.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Chan', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Lucchetta', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cutuli', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Eyeington', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Glassford', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mårtensson', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Angelopoulos', 'Affiliation': 'Department of Cardiac Perfusion, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Matalanis', 'Affiliation': 'Department of Cardiac Surgery, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Weinberg', 'Affiliation': 'Department of Anaesthesia, Austin Hospital, Melbournez, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Australia; School of Medicine, University of Melbourne, Melbourne, Australia; Data Assessment Research Evaluation Centre, University of Melbourne and Austin Hospital, Melbourne, Australia. Electronic address: rinaldo.bellomo@austin.org.au.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.03.012']
709,30475006,Perspectives on a contingency management intervention for alcohol use among consumers with serious mental illness.,"OBJECTIVE


This study describes the perspectives of outpatients with serious mental illness (SMI) and alcohol dependence on their participation in a contingency management (CM) intervention for alcohol use.
METHODS


Thirty-five adults with SMI and alcohol dependence participated in a randomized trial of CM for alcohol use, where they were rewarded with prizes contingent on abstinence from alcohol. All participants were interviewed regarding their participation in CM with a consistent structure that included nine open-ended questions. Favored and disliked aspects of CM, perception of alcohol biomarker accuracy, and interest in participating in similar CM interventions provided by treatment centers, rather than researchers, were explored.
RESULTS


Participants spoke enthusiastically about receiving prizes, as well as how CM increased their awareness of drinking and helped support their abstinence from alcohol. Most participants felt the ethyl glucuronide biomarker urine tests used to measure alcohol use were accurate, and they were interested in enrolling in CM if it was offered as a clinical program. Research staff who implemented the intervention were well regarded by participants, and interactions with research staff were perceived positively.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


Adults with SMI and alcohol dependence participating in a trial of CM for alcohol use reported overall positive perceptions of and experiences with CM. Receiving small tangible prizes and having positive interpersonal interactions with study staff were reported as especially impactful. These findings indicate that CM is well received by consumers, in addition to its empirical and practical benefits as an evidence-based, low-cost intervention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"RESULTS


Participants spoke enthusiastically about receiving prizes, as well as how CM increased their awareness of drinking and helped support their abstinence from alcohol.","['Thirty-five adults with SMI and alcohol dependence participated in a randomized trial of CM for alcohol use, where they were rewarded with prizes contingent on abstinence from alcohol', 'consumers with serious mental illness', 'outpatients with serious mental illness (SMI) and alcohol dependence on their participation in a contingency management (CM) intervention for alcohol use', 'Adults with SMI and alcohol dependence participating']",['contingency management intervention'],[],"[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]",[],[],35.0,0.0309629,"RESULTS


Participants spoke enthusiastically about receiving prizes, as well as how CM increased their awareness of drinking and helped support their abstinence from alcohol.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Leickly', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Skalisky', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Angelo', 'Affiliation': 'School of Public Health, University of Washington.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Srebnik', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Sterling', 'Initials': 'S', 'LastName': 'McPherson', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Roll', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Ries', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McDonell', 'Affiliation': 'Initiative for Research and Education to Advance Community Health, Washington State University.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000330']
710,30590600,When is it appropriate to stop non-vitamin K antagonist oral anticoagulants before catheter ablation of atrial fibrillation? A multicentre prospective randomized study.,"AIMS


Although a recent expert consensus statement has recommended periprocedural uninterrupted (UI) non-vitamin K antagonist oral anticoagulants (NOACs) during catheter ablation of atrial fibrillation (AF) as a Class I indication, there have been no clear randomized trials. We investigated the safety and efficacy of UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs in patients undergoing AF ablation.
METHODS AND RESULTS


In this prospective, open-label, randomized multicentre trial, 326 patients (75% male, 58 ± 11 years old) scheduled for AF catheter ablation were randomly assigned in a 1:1:1 ratio to UI, SDS, and 24S at three tertiary hospitals. Bridging with low molecular weight heparin was carried out in the patients with persistent AF who were assigned to the 24S group. Dabigatran, rivaroxaban, and apixaban were assigned in order after randomization. The primary endpoint was the incidence of bleeding events within 1 month after ablation. The secondary endpoints included thrombo-embolic and other procedure-related complications. The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139). The incidence of major bleeding up to 1 month after ablation and a post-procedural reduction in the haemoglobin levels did not significantly differ among the treatment groups and different NOACs (P > 0.05). There were no fatal events or thrombo-embolic complications in all the three groups.
CONCLUSION


In patients undergoing AF ablation, UI NOACs and SDS or double dose skipped NOACs had a comparable efficacy and safety, regardless of the type of NOAC.",2019,"The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139).","['patients undergoing AF ablation', '326 patients (75% male, 58\u2009±\u200911 years old) scheduled for AF catheter ablation', 'patients with persistent AF who were assigned to the 24S group']","['vitamin K antagonist oral anticoagulants (NOACs', 'Dabigatran, rivaroxaban, and apixaban', 'UI, procedure day single-dose skipped (SDS), and 24-hour skipped (24S) NOACs']","['safety and efficacy', 'incidence of bleeding events', 'mean activated clotting time', 'haemoglobin levels', 'thrombo-embolic and other procedure-related complications', 'incidence of major bleeding', 'efficacy and safety', 'intra-procedural heparin requirement', 'fatal events or thrombo-embolic complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0560435', 'cui_str': 'Does skip (finding)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",326.0,0.072216,"The intra-procedural heparin requirement was higher in the 24S group than others (P < 0.001), and the mean activated clotting time was comparable among the groups (P = 0.139).","[{'ForeName': 'Hee Tae', 'Initials': 'HT', 'LastName': 'Yu', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jaemin', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Korea University Cardiovascular Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Junbeom', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Ewha Womans University, 52 Ewhayeodae-gil, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Sun', 'Initials': 'JS', 'LastName': 'Uhm', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Youn', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Boyoung', 'Initials': 'B', 'LastName': 'Joung', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Moon-Hyoung', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Korea University Cardiovascular Center, 73 Inchon-ro, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Hui-Nam', 'Initials': 'HN', 'LastName': 'Pak', 'Affiliation': 'Yonsei University Health System, 50-1 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea.'}]",European heart journal,['10.1093/eurheartj/ehy870']
711,31076882,Comparative study of nasal septal retainer and nasal packing in patients undergoing septoplasty.,"PURPOSE


Nasal packing is frequently used after septoplasty and some complications caused by nasal packing are unavoidable. A nasal septal retainer has recently been developed. We evaluated the safety and clinical efficacy of the retainer in septoplasty, and the subjective symptoms of patients with the retainer were compared with Merocel nasal packing.
METHODS


A prospective, randomized, controlled study was performed in patients who had undergone septoplasty. In total, 39 patients were randomized to receive Merocel (n = 17) or the retainer (n = 22) after septoplasty. The deviation of nasal septum and nasal mucosa was evaluated by endoscopy. The clinical efficacy and subjective symptoms were compared using the visual analog scale.
RESULTS


During the packing/retaining period, the mean scores of headache, nasal obstruction, epiphora, and facial pressure in the retainer group were significantly lower than in the Merocel group (P < 0.05); the mean scores of nasal pain, nasal itching, rhinorrhea, dysphagia, and sleep disturbance in the retainer group were lower than in the Merocel group, but the difference did not reach statistical significance. On the removal of Merocel/retainer, nasal pain was significantly lower in patients with the retainer (P < 0.05). In the retainer group, the incidence of grade 1 bleeding was 45.5%, and grade 0 bleeding was 54.5%. In the Merocel group, the incidence of grade 2 bleeding was 23.5%, grade 1 was 47.1%, and grade 0 was 29.4%.
CONCLUSIONS


The nasal septal retainer is suitable for use after septoplasty with more beneficial effects than nasal packing.",2019,"During the packing/retaining period, the mean scores of headache, nasal obstruction, epiphora, and facial pressure in the retainer group were significantly lower than in the Merocel group (P < 0.05); the mean scores of nasal pain, nasal itching, rhinorrhea, dysphagia, and sleep disturbance in the retainer group were lower than in the Merocel group, but the difference did not reach statistical significance.","['patients with the retainer were compared with Merocel nasal packing', 'patients undergoing septoplasty', 'patients who had undergone septoplasty', '39 patients']","['nasal septal retainer and nasal packing', 'Merocel']","['clinical efficacy and subjective symptoms', 'mean scores of headache, nasal obstruction, epiphora, and facial pressure', 'removal of Merocel/retainer, nasal pain', 'safety and clinical efficacy', 'grade 0 bleeding', 'mean scores of nasal pain, nasal itching, rhinorrhea, dysphagia, and sleep disturbance', 'deviation of nasal septum and nasal mucosa', 'incidence of grade 2 bleeding', 'incidence of grade 1 bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027429', 'cui_str': 'Nasal Airway Obstruction'}, {'cui': 'C0152227', 'cui_str': 'Epiphora'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0127601', 'cui_str': 'Merocel'}, {'cui': 'C4551580', 'cui_str': 'Retainer (attribute)'}, {'cui': 'C0240564', 'cui_str': 'Pain of nose (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0850060', 'cui_str': 'Nasal pruritus'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0027432', 'cui_str': 'Nasal Septum'}, {'cui': 'C0027428', 'cui_str': 'Nasal Mucosa'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",39.0,0.0151227,"During the packing/retaining period, the mean scores of headache, nasal obstruction, epiphora, and facial pressure in the retainer group were significantly lower than in the Merocel group (P < 0.05); the mean scores of nasal pain, nasal itching, rhinorrhea, dysphagia, and sleep disturbance in the retainer group were lower than in the Merocel group, but the difference did not reach statistical significance.","[{'ForeName': 'Shengjian', 'Initials': 'S', 'LastName': 'Fang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Ying', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Cui', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Zhaoxin', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shanghai East Hospital, Tongji University School of Medicine, 150 Jimo Road, Shanghai, 200120, China. whwangcn@outlook.com.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05455-z']
712,30260488,Dietary Management of Blood Glucose in Medical Critically Ill Overweight and Obese Patients: An Open-Label Randomized Trial.,"BACKGROUND


Enteral nutrition (EN) increases hyperglycemia due to high carbohydrate concentrations while providing insufficient protein. The study tested whether an EN formula with very high-protein- and low-carbohydrate-facilitated glucose control delivered higher protein concentrations within a hypocaloric protocol.
METHODS


This was a multicenter, randomized, open-label clinical trial with parallel design in overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day. Patients received either an experimental very high-protein (37%) and low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula.
RESULTS


A prespecified interim analysis was performed after enrollment of 105 patients (52 experimental, 53 control). Protein and energy delivery for controls and experimental groups on days 1-5 were 1.2 ± 0.4 and 1.1 ± 0.3 g/kg ideal body weight/day (P = .83), and 18.2 ± 6.0 and 12.5 ± 3.7 kcals/kg ideal body weight/day (P < .0001), respectively. The combined rate of glucose events outside the range of >110 and ≤150 mg/dL were not different (P = .54, primary endpoint); thereby the trial was terminated. The mean blood glucose for the control and the experimental groups were 138 (-SD 108, +SD 177) and 126 (-SD 99, +SD 160) mg/dL (P = .004), respectively. Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007). Insulin administration decreased 10.9% (95% CI, -22% to 0.1%; P = .048) in the experimental group relative to the controls. Glycemic events ≤80 mg/dL and rescue dextrose use were not different (P = .23 and P = .53).
CONCLUSIONS


A very high-protein and low-carbohydrate EN formula in a hypocaloric protocol reduces hyperglycemic events and insulin requirements while increasing glycemic events between 80-110 mg/dL.",2019,"Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007).","['Medical Critically Ill Overweight and Obese Patients', 'overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day']","['EN formula with very high-protein- and low-carbohydrate-facilitated glucose control', 'low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula', 'dL', 'Dietary Management of Blood Glucose', 'Enteral nutrition (EN']","['Protein and energy delivery', 'glycemic events', 'mean blood glucose', 'Mean rate of glucose events', 'hyperglycemic events and insulin requirements']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0421272', 'cui_str': 'Normal Body Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.0304656,"Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007).","[{'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Department of Internal Medicine-Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Morris', 'Affiliation': 'University of Kentucky Healthcare, Lexington, Kentucky, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Bernard', 'Affiliation': 'University of Kentucky Healthcare, Lexington, Kentucky, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Ziegler', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Drover', 'Affiliation': ""Department of Critical Care Medicine, Queen's University and Kingston Health Science Center, Kingston, Ontario, Canada.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kress', 'Affiliation': 'The University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'Department of Critical Care Medicine, Regions Hospital, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research Center, Vers-chez-les-Blanc, Lausanne, Switzerland.'}, {'ForeName': 'Maureen B', 'Initials': 'MB', 'LastName': 'Huhmann', 'Affiliation': 'Nestlé Health Science, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Juan B Ochoa', 'Initials': 'JBO', 'LastName': 'Gautier', 'Affiliation': 'Nestlé Health Science, Bridgewater, New Jersey, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1447']
713,32037910,Does metformin affect mammographic breast density in postmenopausal women with type 2 diabetes.,"Background:  Increased mammographic breast density (MBD) is known to be associated with an increased risk of developing breast cancer. Aims:  In this study, we aimed to research the possible relationship between MBD and metformin use in postmenopausal women diagnosed with type 2 diabetes mellitus (T2DM). Method:  The patients were divided into two groups: women with T2DM and who were on metformin and women who were newly diagnosed with T2DM and had not yet taken metformin. MBD types are evaluated by a specialist radiologist. Results:  Among the 74 women, 32 (43.2%) were in the group that did not use metformin and 42 (56.8%) were in the group of patients using metformin. The duration of breastfeeding ( p  = .0003), fasting blood glucose ( p  = .0003) and HbA1c ( p  = .0006) were statistically significantly higher in the group not using metformin. The quantitative mean ranks of the group members' MBD's were 41.81 in the metformin naïve group and 34.21 in the group using metformin ( p  = .12). Conclusions:  In conclusion, metformin has no statistically significant effect on MBD in postmenopausal female patients with T2DM.",2020,"The duration of breastfeeding ( p  = .0003), fasting blood glucose ( p  = .0003) and HbA1c ( p  = .0006) were statistically significantly higher in the group not using metformin.","['postmenopausal women with type 2 diabetes', 'postmenopausal women diagnosed with type 2 diabetes mellitus (T2DM', 'postmenopausal female patients with T2DM', 'patients were divided into two groups: women with T2DM and who were on metformin and women who were newly diagnosed with T2DM and had not yet taken metformin']","['metformin', 'MBD and metformin']","['fasting blood glucose', 'duration of breastfeeding', 'mammographic breast density (MBD', 'MBD', ""MBD's""]","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1268717', 'cui_str': 'Mammographic Density'}]",74.0,0.0230802,"The duration of breastfeeding ( p  = .0003), fasting blood glucose ( p  = .0003) and HbA1c ( p  = .0006) were statistically significantly higher in the group not using metformin.","[{'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Ozturk', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Serpil', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Muzeyyen', 'Initials': 'M', 'LastName': 'Eryilmaz', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Cinar', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Sertbas', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Feyza', 'Initials': 'F', 'LastName': 'Ak', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Sertbas', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Internal Medicine, Fatih Sultan Mehmet Education and Research Hospital, Istanbul, Turkey.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1725972']
714,30896356,"Impact of exercise-induced hypohydration on gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profile.","It is commonly believed that gastrointestinal issues during exercise are exacerbated by hypohydration. This study aimed to determine the effect of exercise-induced hypohydration on gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profiles. In a randomized crossover design, male endurance runners ( n  = 11) performed 2 h of running at 70% of maximum oxygen uptake in 25°C ambient temperature with water provision [euhydration (EuH)] and total water restriction [hypohydration (HypoH)] during running, which accounted for 0.6 ± 0.6% and 3.1 ± 0.7% body mass loss, respectively. Blood and fecal samples were collected before and after exercise. Breath samples (H 2  determination) were collected and gastrointestinal symptoms (GIS) recorded before, during, and after exercise. HypoH resulted in a higher, yet insignificant, ∆ preexercise to postexercise plasma cortisol concentration (+286 nmol/l vs. +176 nmol/l;  P  = 0.098) but significantly higher intestinal fatty acid-binding protein (I-FABP) (+539 pg/ml vs. +371 pg/ml;  P  = 0.047) concentration compared with EuH. A greater breath H 2  response ( P  = 0.026) was observed on HypoH (1,188 ppm/3 h, peak +12 ppm) vs. EuH (579 ppm/3 h, peak +6 ppm). Despite greater GIS incidence on HypoH (82%) vs. EuH (64%), GIS severity scores were not significant between trials. Exercise-induced leukocytosis (overall pre- to postexercise: 5.9 × 10 9 /l to 12.1 × 10 9 /l) was similar on both trials. Depressed in vitro neutrophil function was observed during recovery on HypoH (-36%) but not on EUH (+6%). A pre- to postexercise increase ( P  < 0.05) was observed for circulating cytokine concentrations but not endotoxin values. Hypohydration during 2 h of running modestly perturbs gastrointestinal integrity and function and increases GIS incidence but does not affect systemic endotoxemia and cytokinemia.  NEW & NOTEWORTHY  Despite anecdotal beliefs that exercise-induced hypohydration exacerbates perturbations to gastrointestinal status, the present study reports only modest perturbations in gastrointestinal integrity, function, and symptoms compared with euhydration maintenance. Exercise-induced hypohydration does not exacerbate systemic endotoxemia and cytokinemia compared with euhydration maintenance. Programmed water intake to maintain euhydration results in gastrointestinal symptom severity similar to exercise-induced hypohydration. Maintaining euhydration during exertional stress prevents the exercise-associated depression in bacterially stimulated neutrophil function.",2019,"HypoH resulted in a higher, yet insignificant, ∆ preexercise to postexercise plasma cortisol concentration (+286 nmol/l vs. +176 nmol/l;  P  = 0.098) but significantly higher intestinal fatty acid-binding protein (I-FABP) (+539 pg/ml vs. +371 pg/ml;  P  = 0.047) concentration compared with EuH. A greater breath H 2  response ( P  = 0.026) was observed on HypoH (1,188 ppm/3 h, peak +12 ppm) vs. EuH (579 ppm/3 h, peak +6 ppm).",['male endurance runners ( n  = 11'],"['performed 2 h of running at 70% of maximum oxygen uptake in 25°C ambient temperature with water provision [euhydration (EuH)] and total water restriction [hypohydration (HypoH', 'exercise-induced hypohydration', 'Exercise-induced hypohydration']","['gastrointestinal integrity and function and increases GIS incidence', 'gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profile', 'circulating cytokine concentrations', '∆ preexercise to postexercise plasma cortisol concentration', 'intestinal fatty acid-binding protein', 'gastrointestinal integrity, function, symptoms, and systemic endotoxin and inflammatory profiles', 'vitro neutrophil function', 'GIS severity scores', 'Exercise-induced leukocytosis', 'Blood and fecal samples']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake (observable entity)'}, {'cui': 'C0542496', 'cui_str': 'Ambient temperature (observable entity)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0163314', 'cui_str': 'Fatty Acid-Binding Proteins, Intestinal-Specific'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023518', 'cui_str': 'Leukocytosis'}, {'cui': 'C0005768'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0910886,"HypoH resulted in a higher, yet insignificant, ∆ preexercise to postexercise plasma cortisol concentration (+286 nmol/l vs. +176 nmol/l;  P  = 0.098) but significantly higher intestinal fatty acid-binding protein (I-FABP) (+539 pg/ml vs. +371 pg/ml;  P  = 0.047) concentration compared with EuH. A greater breath H 2  response ( P  = 0.026) was observed on HypoH (1,188 ppm/3 h, peak +12 ppm) vs. EuH (579 ppm/3 h, peak +6 ppm).","[{'ForeName': 'Ricardo J S', 'Initials': 'RJS', 'LastName': 'Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Camões-Costa', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}, {'ForeName': 'Rhiannon M J', 'Initials': 'RMJ', 'LastName': 'Snipe', 'Affiliation': 'Centre for Sport Research, School of Exercise and Nutrition Sciences, Deakin University, Burwood, Victoria , Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Writtle University College , Chelmsford , United Kingdom.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Russo', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}, {'ForeName': 'Zoya', 'Initials': 'Z', 'LastName': 'Huschtscha', 'Affiliation': 'Department of Nutrition, Dietetics and Food, Monash University, Notting Hill, Victoria , Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01032.2018']
715,31734702,Effect of Face-to-Face vs Virtual Reality Training on Cardiopulmonary Resuscitation Quality: A Randomized Clinical Trial.,"Importance


Bystander cardiopulmonary resuscitation (CPR) is crucial for survival after cardiac arrest but not performed in most cases. New, low-cost, and easily accessible training methods, such as virtual reality (VR), may reach broader target populations, but data on achieved CPR skills are lacking.
Objective


To compare CPR quality between VR and face-to-face CPR training.
Design, Setting, and Participants


Randomized noninferiority trial with a prospective randomized open blinded end point design. Participants were adult attendees from the science section of the Lowlands Music Festival (August 16 to 18, 2019) in the Netherlands. Analysis began September 2019.
Interventions


Two standardized 20-minute protocols on CPR and automated external defibrillator use: instructor-led face-to-face training or VR training using a smartphone app endorsed by the Resuscitation Council (United Kingdom).
Main Outcomes and Measures


During a standardized CPR scenario following the training, we assessed the primary outcome CPR quality, measured as chest compression depth and rate using CPR manikins. Overall CPR performance was assessed by examiners, blinded for study groups, using a European Resuscitation Council-endorsed checklist (maximum score, 13). Additional secondary outcomes were chest compression fraction, proportions of participants with mean depth (50 mm-60 mm) or rate (100 min-1-120 min-1) within guideline ranges, and proportions compressions with full release.
Results


A total of 381 participants were randomized: 216 women (57%); median (interquartile range [IQR]) age, 26 (22-31) years. The VR app (n = 190 [49.9%]) was inferior to face-to-face training (n = 191 [50.1%]) for chest compression depth (mean [SD], VR: 49 [10] mm vs face to face: 57 [5] mm; mean [95% CI] difference, -8 [-9 to -6] mm), and noninferior for chest compression rate (mean [SD]: VR: 114 [12] min-1 vs face to face: 109 [12] min-1; mean [95% CI] difference, 6 [3 to 8] min-1). The VR group had lower overall CPR performance scores (median [IQR], 10 [8-12] vs 12 [12-13]; P < .001). Chest compression fraction (median [IQR], 61% [52%-66%] vs 67% [62%-71%]; P < .001) and proportions of participants fulfilling depth (51% [n = 89] vs 75% [n = 133], P < .001) and rate (50% [n = 87] vs 63% [n = 111], P = .01) requirements were also lower in the VR group. The proportion of compressions with full release was higher in the VR group (median [IQR], 98% [59%-100%] vs 88% [55%-99%]; P = .002).
Conclusions and Relevance


In this randomized noninferiority trial, VR training resulted in comparable chest compression rate but inferior compression depth compared with face-to-face training. Given the potential of VR training to reach a larger target population, further development is needed to achieve the compression depth and overall CPR skills acquired by face-to-face training.
Trial Registration


ClinicalTrials.gov identifier: NCT04013633.",2020,"The VR app (n = 190 [49.9%]) was inferior to face-to-face training (n = 191 [50.1%]) for chest compression depth (mean [SD], VR: 49 [10] mm vs face to face:","['381 participants were randomized: 216 women (57%); median (interquartile range [IQR]) age, 26 (22-31) years', 'Participants were adult attendees from the science section of the Lowlands Music Festival (August 16 to 18, 2019) in the Netherlands']","['CPR and automated external defibrillator use: instructor-led face-to-face training or VR training using a smartphone app endorsed by the Resuscitation Council (United Kingdom', 'Bystander cardiopulmonary resuscitation (CPR', 'Face-to-Face vs Virtual Reality Training', 'VR training']","['Cardiopulmonary Resuscitation Quality', 'chest compression depth', 'CPR quality', 'Chest compression fraction', 'overall CPR performance scores', 'Overall CPR performance', 'proportion of compressions with full release', 'chest compression fraction, proportions of participants with mean depth (50 mm-60 mm) or rate', 'CPR quality, measured as chest compression depth and rate using CPR manikins', 'chest compression rate']","[{'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0015922', 'cui_str': 'Festivals'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0450400', 'cui_str': '50mm (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]",381.0,0.0762093,"The VR app (n = 190 [49.9%]) was inferior to face-to-face training (n = 191 [50.1%]) for chest compression depth (mean [SD], VR: 49 [10] mm vs face to face:","[{'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Hella E C', 'Initials': 'HEC', 'LastName': 'Muijsers', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Sandra G A M', 'Initials': 'SGAM', 'LastName': 'Ahoud-Schoenmakers', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Judith L', 'Initials': 'JL', 'LastName': 'Bonnes', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.4992']
716,31734701,Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial.,"Importance


Guidelines recommend exercise training as a component of heart failure management. There are large disparities in access to rehabilitation, and introducing hybrid comprehensive telerehabilitation (HCTR) consisting of remote monitoring of training at patients' homes might be an appealing alternative.
Objective


To assess whether potential improvements in quality-of-life outcomes after a 9-week HCTR intervention in patients with heart failure translate into improvement in clinical outcomes during extended 12 to 24 months of follow-up, compared with usual care.
Design, Setting, and Participants


The Telerehabilitation in Heart Failure Patients (TELEREH-HF) trial is a multicenter, prospective, open-label, parallel-group randomized clinical trial that enrolled 850 patients with heart failure up to 6 months after a cardiovascular hospitalization with New York Heart Association levels I, II, or III and left ventricular ejection fraction of 40% or less. Patients from 5 centers in Poland were randomized 1:1 to HCTR plus usual care or usual care only and followed up for 14 to 26 months after randomization.
Interventions


During the first 9 weeks, patients underwent either an HCTR program (1 week in hospital and 8 weeks at home) or usual care with observation. The HCTR intervention encompassed telecare, telerehabilitation, and remote monitoring of implantable devices. No intervention occurred in the remaining study period.
Main Outcomes and Measures


The percentage of days alive and out of the hospital from randomization through the end of follow-up at 14 to 26 months.
Results


A total of 850 patients were enrolled, with 425 randomized to the HCTR group (377 male patients [88.7%]; mean [SD] age, 62.6 [10.8] years) and 425 randomized to usual care (376 male patients [88.5%]; mean [SD] age, 62.2 [10.2] years). The HCTR intervention did not extend the percentage of days alive and out of the hospital. The mean (SD) days were 91.9 (19.3) days in the HCTR group vs 92.8 (18.3) days in the usual-care group, with the probability that HCTR extends days alive and out of the hospital equal to 0.49 (95% CI, 0.46-0.53; P = .74) vs usual care. During follow-up, 54 patients died in the HCTR arm and 52 in the usual-care arm, with mortality rates at 26 months of 12.5% vs 12.4%, respectively (hazard ratio, 1.03 [95% CI, 0.70-1.51]). There were also no differences in hospitalization rates (hazard ratio, 0.94 [95% CI, 0.79-1.13]). The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, -0.31 to 0.30] mL/kg/min; P < .001) and quality of life (Medical Outcome Survey Short Form-36 questionnaire score, 1.58 [95% CI, 0.74-2.42] vs 0.00 [95% CI, -0.84 to 0.84]; P = .008), and it was well tolerated, with no serious adverse events during exercise.
Conclusions and Relevance


In this trial, the positive effects of a 9-week program of HCTR in patients with heart failure did not lead to the increase in percentage of days alive and out of the hospital and did not reduce mortality and hospitalization over a follow-up period of 14 to 26 months.
Trial Registration


ClinicalTrials.gov identifier: NCT02523560.",2020,"The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, -0.31 to 0.30]","['Heart Failure Patients (TELEREH-HF', 'patients with heart failure', 'Heart Failure Patients ', 'Patients With Heart Failure', 'enrolled 850 patients with heart failure up to 6 months after a cardiovascular hospitalization with New York Heart Association levels I, II, or III and left ventricular ejection fraction of 40% or less', 'Patients from 5 centers in Poland', 'mean [SD] age, 62.2 [10.2] years', '850 patients were enrolled, with 425 randomized to the HCTR group (377 male patients [88.7%]; mean [SD] age, 62.6 [10.8] years) and 425 randomized to usual care (376 male patients [88.5']","['HCTR', '9-Week Hybrid Comprehensive Telerehabilitation Program', 'HCTR intervention', 'HCTR program', 'exercise training', 'HCTR plus usual care or usual care']","['mean (SD) days', 'mortality rates', 'quality of life (Medical Outcome Survey Short Form-36 questionnaire score', 'percentage of days alive and out of the hospital', 'hospitalization rates', 'quality-of-life outcomes', 'peak oxygen consumption']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517523', 'cui_str': '10.8'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0034380'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",850.0,0.106485,"The HCTR intervention was effective at 9 weeks, significantly improving peak oxygen consumption (0.95 [95% CI, 0.65-1.26] mL/kg/min vs 0.00 [95% CI, -0.31 to 0.30]","[{'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Piotrowicz', 'Affiliation': 'Telecardiology Center, Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Pencina', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Opolski', 'Affiliation': 'Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Kowalik', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Orzechowski', 'Affiliation': 'Telecardiology Center, Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Szalewska', 'Affiliation': 'Department of Rehabilitation Medicine, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Pluta', 'Affiliation': 'Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases, Silesian Medical University, Zabrze, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Glówczynska', 'Affiliation': 'Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Irzmanski', 'Affiliation': 'Department of Internal Medicine and Cardiac Rehabilitation, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Oreziak', 'Affiliation': 'Department of Arrhythmia, Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Kalarus', 'Affiliation': 'Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Silesian Center for Heart Diseases, Silesian Medical University, Zabrze, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Lewicka', 'Affiliation': 'Department of Cardiology and Electrotherapy, Medical University of Gdańsk, Gdańsk, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Cacko', 'Affiliation': 'Department of Medical Informatics and Telemedicine, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mierzynska', 'Affiliation': 'Department of Cardiac Rehabilitation and Noninvasive Electrocardiology, Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Ryszard', 'Initials': 'R', 'LastName': 'Piotrowicz', 'Affiliation': 'Department of Cardiac Rehabilitation and Noninvasive Electrocardiology, Institute of Cardiology, Warsaw, Poland.'}]",JAMA cardiology,['10.1001/jamacardio.2019.5006']
717,30218286,"The Effects of Probiotic Honey Consumption on Metabolic Status in Patients with Diabetic Nephropathy: a Randomized, Double-Blind, Controlled Trial.","To the best of our knowledge, this study is the first evaluating the effects of probiotic honey intake on glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress in patients with diabetic nephropathy (DN). This investigation was conducted to evaluate the effects of probiotic honey intake on metabolic status in patients with DN. This randomized, double-blind, controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 25 g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11 (IBRC-M10791) (10 8  CFU/g) or 25 g/day control honey (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and 12 weeks after supplementation to quantify glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress. After 12 weeks of intervention, patients who received probiotic honey compared with the control honey had significantly decreased serum insulin levels (- 1.2 ± 1.8 vs. - 0.1 ± 1.3 μIU/mL, P = 0.004) and homeostasis model of assessment-estimated insulin resistance (- 0.5 ± 0.6 vs. 0.003 ± 0.4, P = 0.002) and significantly improved quantitative insulin sensitivity check index (+ 0.005 ± 0.009 vs. - 0.0007 ± 0.005, P = 0.004). Additionally, compared with the control honey, probiotic honey intake has resulted in a significant reduction in total-/HDL-cholesterol (- 0.2 ± 0.5 vs. + 0.1 ± 0.1, P = 0.04). Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey. Probiotic honey intake had no significant effects on other metabolic profiles compared with the control honey. Overall, findings from the current study demonstrated that probiotic honey consumption for 12 weeks among DN patients had beneficial effects on insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels, but did not affect other metabolic profiles. http://www.irct.ir: IRCT201705035623N115.",2019,"Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey.","['patients with diabetic nephropathy (DN', 'patients with DN', 'Patients with Diabetic Nephropathy', '60 patients with DN']","['Probiotic Honey Consumption', 'probiotic honey intake', '25\xa0g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11']","['serum high-sensitivity C-reactive protein (hs-CRP', 'serum insulin levels', 'quantitative insulin sensitivity check index', 'homeostasis model of assessment-estimated insulin resistance', 'plasma malondialdehyde (MDA) levels', 'metabolic status', 'insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels', 'probiotic honey consumption', 'Fasting blood samples', 'Metabolic Status', 'metabolic profiles', 'glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress', 'glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress', 'total-/HDL-cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",60.0,0.0768944,"Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey.","[{'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazruei Arani', 'Affiliation': 'Department of Food Science and Technology, North Tehran Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Emam-Djomeh', 'Affiliation': 'Department of Food Science, Technology and Engineering Faculty of Agricultural Engineering and Technology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Tavakolipour', 'Affiliation': 'Department of Food Science and Technology, Sabzevar Branch, Islamic Azad University, Sabzevar, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sharafati-Chaleshtori', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9468-x']
718,25174150,Culturally relevant model program to prevent and reduce agricultural injuries.,"Limited research has explored pesticide injury prevention among American Indian farmers. In a five-year agricultural intervention, a university-community partnership, including the University of New Mexico School of Medicine, New Mexico State University, Shiprock Area Cooperative Extension Service, and Navajo Nation communities, used a culturally relevant model to introduce and maintain safe use of integrated pest management techniques. We applied the Diffusion of Innovations theory and community-based approaches to tailor health promotion strategies for our intervention. In a longitudinal study with repeated measures, we trained six ""model farmers"" to be crop management experts in pesticide safety, application, and control. Subsequently, these model farmers worked with 120 farm families randomized into two groups: intervention (Group 1) and delayed intervention (Group 2). Measurements included a walk-through analysis, test of knowledge and attitudes, and yield analysis. Both groups demonstrated improvements in pesticide storage behaviors after training. Test scores regarding safety practices improved significantly: from 57.3 to 72.4 for Group 1 and from 52.6 to 76.3 for Group 2. Group 1 maintained their knowledge and safety practices after the intervention. Attitudes about pesticides and communication of viewpoints changed across the study years. With pesticides and fertilizer, the number of corn ears increased by 56.3% and yield (kg m(-2)) of alfalfa increased by 41.2%. The study combined traditional farming practices with culturally relevant approaches and behavior change theory to affect knowledge, safety practices, attitudes, communication channels, and crop yield. Storage behaviors, use of pesticides and safety and application equipment, and safety practice knowledge changed significantly, as did attitudes about social networking, social support, and the compatibility and relative advantage of pesticides for farms.",2014,Test scores regarding safety practices improved significantly: from 57.3 to 72.4 for Group 1 and from 52.6 to 76.3 for Group 2.,['American Indian farmers'],['delayed intervention'],"['knowledge and safety practices', 'Test scores regarding safety practices', 'walk-through analysis, test of knowledge and attitudes, and yield analysis', 'alfalfa', 'pesticide storage behaviors', 'number of corn ears']","[{'cui': 'C0002460', 'cui_str': 'American Indians'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0939897', 'cui_str': 'Alfalfa preparation'}, {'cui': 'C0031253', 'cui_str': 'Pesticides'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087179', 'cui_str': 'Zea'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}]",,0.0160567,Test scores regarding safety practices improved significantly: from 57.3 to 72.4 for Group 1 and from 52.6 to 76.3 for Group 2.,"[{'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Helitzer', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hathorn', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benally', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': ''}]",Journal of agricultural safety and health,[]
719,31060979,"Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial.","BACKGROUND


Guadecitabine is a next-generation hypomethylating agent whose active metabolite decitabine has a longer in-vivo exposure time than intravenous decitabine. More effective hypomethylating agents are needed for the treatment of myelodysplastic syndromes. In the present study, we aimed to compare the activity and safety of two doses of guadecitabine in hypomethylating agent treatment-naive or relapsed or refractory patients with intermediate-risk or high-risk myelodysplastic syndromes.
METHODS


This phase 2 part of the phase 1/2, randomised, open-label study enrolled patients aged 18 years or older from 14 North American medical centres with International Prognostic Scoring System intermediate-1-risk, intermediate-2-risk, or high-risk myelodysplastic syndromes, or chronic myelomonocytic leukaemia. They were either hypomethylating agent treatment-naive or had relapsed or refractory disease after previous hypomethylating agent treatment as determined by the investigators' judgment. Eligible patients had Eastern Cooperative Oncology Group performance status of 0-2. Patients were randomly assigned (1:1) using a computer algorithm for dynamic randomisation to subcutaneous guadecitabine 60 or 90 mg/m 2  on days 1-5 of a 28-day treatment cycle. Treatment was stratified by previous treatment with hypomethylating agents and neither patients nor investigators were masked. The primary endpoint was overall response (a composite of complete response, partial response, marrow complete response, and haematological improvement) assessed in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT01261312.
FINDINGS


Between July 9, 2012, and April 7, 2014, 105 patients were enrolled: 55 (52%) were allocated to guadecitabine 60 mg/m 2  (28 patients were treatment-naive and 27 had relapsed or refractory disease after previous hypomethylating agent treatment) and 50 (48%) patients to 90 mg/m 2  (23 patients were treatment-naive and 27 had relapsed or refractory disease). Three (3%) patients of 105 did not receive study treatment and were excluded from analyses. Median follow-up was 3·2 years (IQR 2·8-3·5). The proportion of patients achieving an overall response did not significantly differ between dose groups (21 of 53 [40%, 95% CI 27-54] with 60 mg/m 2  and 27 of 49 [55%, 95% CI 40-69] with 90 mg/m 2 ; p=0·16). 25 of 49 (51%, 95% CI 36-66) patients who were treatment-naive and 23 of 53 (43%, 30-58) patients with relapsed or refractory disease achieved an overall response. The most common grade 3 or worse adverse events in both groups, regardless of relationship to treatment, were thrombocytopenia (22 [41%] of 53 patients in the 60 mg/m 2  group and 28 [57%] of 49 in the 90 mg/m 2  group), neutropaenia (21 [40%] and 25 [51%]), anaemia (25 [47%] and 24 [49%]), febrile neutropaenia (17 [32%] and 21 [43%]), and pneumonia (13 [25%] and 15 [31%]). Seven (7%) of 102 patients died due to adverse events (three with 90 mg/m 2  and four with 60 mg/m 2 ), and all except one were in the relapsed or refractory cohort. Two deaths were deemed treatment related (septic shock with 60 mg/m 2 ; pneumonia with 90 mg/m 2 ).
INTERPRETATION


Guadecitabine was clinically active with acceptable tolerability in patients with intermediate-risk and high-risk myelodysplastic syndromes. Responses and overall survival in the relapsed or refractory cohort offer the potential of a new therapeutic option for patients for whom currently available hypomethylating agents are not successful. We therefore recommend guadecitabine at a dose of 60 mg/m 2  on a 5-day schedule for these patients.
FUNDING


Astex Pharmaceuticals and Stand Up To Cancer.",2019,"The proportion of patients achieving an overall response did not significantly differ between dose groups (21 of 53 [40%, 95% CI 27-54] with 60 mg/m 2  and 27 of 49 [55%, 95% CI 40-69] with 90 mg/m 2 ; p=0·16).","['hypomethylating agent treatment-naive or relapsed or refractory patients with intermediate-risk or high-risk myelodysplastic syndromes', 'Between July 9, 2012, and April 7, 2014, 105 patients were enrolled: 55 (52', 'patients with intermediate or high-risk myelodysplastic syndromes', 'Eligible patients had Eastern Cooperative Oncology Group performance status of 0-2', 'patients with intermediate-risk and high-risk myelodysplastic syndromes', 'patients aged 18 years or older from 14 North American medical centres with International Prognostic Scoring System intermediate-1-risk, intermediate-2-risk, or high-risk myelodysplastic syndromes, or chronic myelomonocytic leukaemia']","['guadecitabine', 'Guadecitabine (SGI-110', 'computer algorithm for dynamic randomisation to subcutaneous guadecitabine']","['neutropaenia', 'Responses and overall survival', 'anaemia', 'adverse events', 'activity and safety', 'overall response (a composite of complete response, partial response, marrow complete response, and haematological improvement', 'febrile neutropaenia', 'proportion of patients achieving an overall response', 'overall response', 'thrombocytopenia']","[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0023480', 'cui_str': 'Leukemia, Myelomonocytic, Chronic'}]","[{'cui': 'C3899005', 'cui_str': 'guadecitabine'}, {'cui': 'C2986994', 'cui_str': 'SGI-110'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0002045'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0330477', 'cui_str': 'Cucurbita'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",105.0,0.0904329,"The proportion of patients achieving an overall response did not significantly differ between dose groups (21 of 53 [40%, 95% CI 27-54] with 60 mg/m 2  and 27 of 49 [55%, 95% CI 40-69] with 90 mg/m 2 ; p=0·16).","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ggarciam@mdanderson.org.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Roboz', 'Affiliation': 'New York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Walsh', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Ritchie', 'Affiliation': 'New York-Presbyterian/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kropf', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': ""O'Connell"", 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Tibes', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lunin', 'Affiliation': 'Fort Myers Cancer Center, Fort Myers, FL, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rosenblat', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Yee', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'The University of Chicago Medicine Comprehensive Cancer Center, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Griffiths', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mace', 'Affiliation': 'Florida Cancer Specialists & Research Institute, St Petersburg, FL, USA.'}, {'ForeName': 'Nikolai', 'Initials': 'N', 'LastName': 'Podoltsev', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Berdeja', 'Affiliation': 'Sarah Cannon Cancer Center, Nashville, TN, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jean-Pierre J', 'Initials': 'JJ', 'LastName': 'Issa', 'Affiliation': 'Fels Institute for Cancer Research & Molecular Biology, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'Astex Pharmaceuticals, Pleasanton, CA, USA.'}, {'ForeName': 'Harold N', 'Initials': 'HN', 'LastName': 'Keer', 'Affiliation': 'Astex Pharmaceuticals, Pleasanton, CA, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azab', 'Affiliation': 'Astex Pharmaceuticals, Pleasanton, CA, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Savona', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(19)30029-8']
720,31852380,Pharmacokinetics and pharmacodynamics of a recombinant fusion protein linking activated coagulation factor VII with human albumin (rVIIa-FP) in patients with congenital FVII deficiency.,"Objectives:  Recombinant fusion protein linking activated factor VIIa to human albumin (rVIIa-FP) is a therapeutic option designed to prevent and treat bleeding events in patients with congenital FVII deficiency with reduced infusion frequency compared to current FVII treatments. This study characterized the pharmacokinetics (PK) and pharmacodynamics (PD) of rVIIa-FP. Methods:  A phase I multicenter, randomized, open-label, parallel-arm, single-dose study (NCT02470871) was conducted in nine patients with severe congenital FVII deficiency. Patients received their routine FVII product (30 IU/kg plasma-derived FVII [pdFVII] or 25 μg/kg recombinant activated FVII (rFVIIa) [eptacog alfa]), and were then randomly assigned to receive 100 or 300 μg/kg of rVIIa-FP. Blood samples for PK and PD assessments were drawn up to 48 hr after administration. FVIIa activity was determined using a one-stage clotting assay. PD parameters were derived from thrombin generation testing, using the Nijmegen hemostasis assay. Results:  rVIIa-FP showed improved PK compared to rFVIIa, with 2- to 3-fold longer t 1/2  and 4- to 8-fold lower clearance. Analysis of PD data showed a sustained suppression of lag time below 4.5 min (upper limit of healthy people) for rVIIa-FP compared to rFVIIa. AUEC and EC max  were similar across the two dose groups of rVIIa-FP and rFVIIa. Discussion : rVIIa-FP was well tolerated in patients with congenital FVII deficiency, showed a longer half-life and lower clearance compared to rFVIIa, and lag time remaining within healthy ranges for ≥8 hr. Conclusion:  These results warrant further investigation into the efficacy of rVIIa-FP to control and prevent bleeding in patients with FVII deficiency.",2020,AUEC and EC max  were similar across the two dose groups of rVIIa-FP and rFVIIa.,"['patients with FVII deficiency', 'nine patients with severe congenital FVII deficiency', 'patients with congenital FVII deficiency']","['recombinant fusion protein linking activated coagulation factor VII with human albumin (rVIIa-FP', 'Recombinant fusion protein linking activated factor VIIa to human albumin (rVIIa-FP', 'rVIIa-FP', 'routine FVII product (30\u2005IU/kg plasma-derived FVII [pdFVII] or 25\u2005μg/kg recombinant activated FVII (rFVIIa']","['AUEC and EC max', 'FVIIa activity', 'sustained suppression of lag time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}]","[{'cui': 'C0034857', 'cui_str': 'Recombinant Fusion Proteins'}, {'cui': 'C4521950', 'cui_str': 'Activated coagulation factor'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0015505', 'cui_str': 'Factor VIIa'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0534191', 'cui_str': 'recombinant FVIIa'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0173771,AUEC and EC max  were similar across the two dose groups of rVIIa-FP and rFVIIa.,"[{'ForeName': 'Britta Laros-van', 'Initials': 'BL', 'LastName': 'Gorkom', 'Affiliation': 'Department of Hematology and Hemophilia Treatment Center Nijmegen-Eindhoven-Maastricht, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Pål André', 'Initials': 'PA', 'LastName': 'Holme', 'Affiliation': 'Department of Hematology, Oslo University Hospital and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Joch', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Rogosch', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Feussner', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McKeand', 'Affiliation': 'CSL Behring, King of Prussia, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'CSL Behring, King of Prussia, USA.'}, {'ForeName': 'Waander', 'Initials': 'W', 'LastName': 'van Heerde', 'Affiliation': 'Department of Hematology and Hemophilia Treatment Center Nijmegen-Eindhoven-Maastricht, Radboud University Medical Center, Nijmegen, The Netherlands.'}]","Hematology (Amsterdam, Netherlands)",['10.1080/16078454.2019.1700329']
721,31606398,Moderators of Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Chronic Pain: Who Benefits From Treatment at Long-Term Follow-Up?,"Cognitive behavioral therapy (CBT) is effective for pediatric chronic pain, but little is understood about which youth are most likely to benefit. The current study aimed to identify individual characteristics for which CBT yielded the greatest (and least) clinical benefit among adolescents with chronic pain participating in a multicenter randomized controlled trial of Internet-delivered CBT (WebMAP2). A total of 273 adolescents ages 11 to 17 with chronic pain (M age = 14.7; 75.1% female) were randomly assigned to Internet-delivered CBT or Internet-delivered pain education and evaluated at pretreatment, post-treatment, and 2 longer term follow-up periods (6 and 12 months). Multilevel growth models tested several adolescent- and parent-level moderators of change in pain-related disability including 1) adolescent age, sex, pain characteristics, distress, and sleep quality and 2) parent education level, distress, and protective parenting behavior. Younger adolescents (ages 11-14; vs older adolescents ages 15-17) and those whose parents experienced lower levels (vs higher levels) of emotional distress responded better to Internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment. This study expands knowledge on who benefits most from Internet-delivered psychological treatment for youth with chronic pain in the context of a large multicenter randomized controlled trial, suggesting several avenues for maximizing treatment efficacy and durability in this population. PERSPECTIVE: This study identified adolescent- and parent-level predictors of treatment response to Internet-based CBT for pediatric chronic pain up to 12 months later. Younger adolescents and those whose parents had lower levels of distress may particularly benefit from this intervention. Older adolescents and those whose parents exhibit higher distress may require alternative treatment approaches.",2020,"Young adolescents (ages 11-14 vs. older adolescents ages 15-17) and those whose parents experienced lower levels (vs. higher levels) of emotional distress responded better to internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment.","['Young adolescents (ages 11-14 vs. older adolescents ages 15-17', 'Older adolescents', 'adolescents with chronic pain participating in a multi-center randomized controlled trial (RCT) of', '273 adolescents ages 11-17 with chronic pain (Mage=14.7; 75.1% female', 'adolescents with chronic pain', 'Younger adolescents', 'youth with chronic pain']","['internet-delivered cognitive-behavioral therapy', 'Internet-based CBT', 'internet-delivered CBT (WebMAP2', 'Cognitive-behavioral therapy (CBT', 'internet-delivered CBT or internet-delivered pain education and evaluated at pre-treatment, post-treatment']","['pain-related disability including (1) adolescent age, sex, pain characteristics, distress, and sleep quality and (2) parent education level, distress, and protective parenting behaviors', 'disability', 'emotional distress']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}]",273.0,0.0873187,"Young adolescents (ages 11-14 vs. older adolescents ages 15-17) and those whose parents experienced lower levels (vs. higher levels) of emotional distress responded better to internet CBT treatment, showing greater improvements in disability up to 12 months post-treatment.","[{'ForeName': 'Caitlin B', 'Initials': 'CB', 'LastName': 'Murray', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington. Electronic address: caitlin.murray@seattlechildrens.org.""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'de la Vega', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Loren', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; Loyola University Chicago, Chicago, Illinois.""}, {'ForeName': 'Tonya M', 'Initials': 'TM', 'LastName': 'Palermo', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington; University of Washington, Seattle, Washington.""}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.001']
722,31439579,"POSEIDON Trial Phase 1b Results: Safety, Efficacy and Circulating Tumor DNA Response of the Beta Isoform-Sparing PI3K Inhibitor Taselisib (GDC-0032) Combined with Tamoxifen in Hormone Receptor Positive Metastatic Breast Cancer Patients.","PURPOSE


The strategy of combining endocrine therapy with PI3K-mTOR inhibition has shown promise in estrogen receptor (ER)-positive breast cancer, but new agents and combinations with a better therapeutic index are urgently needed. Taselisib is a potent, selective, beta-isoform-sparing PI3 kinase inhibitor.
PATIENTS AND METHODS


30 patients with ER-positive, metastatic breast cancer who had failed prior endocrine therapy were treated with escalating doses of taselisib (2 or 4 mg in an intermittent or continuous schedule) combined with tamoxifen 20 mg once daily in this phase 1b study using a ""rolling six"" design.
RESULTS


Taselisib combined with tamoxifen was generally well tolerated, with treatment-emergent adverse events as expected for this class of drugs, including diarrhea (13 patients, 43%), mucositis (10 patients, 33%), and hyperglycemia (8 patients, 27%). No dose-limiting toxicities were observed. Objective responses were seen in 6 of 25 patients with RECIST-measurable disease (ORR 24%). Median time to disease progression was 3.7 months. Twelve of 30 patients (40%) had disease control for 6 months or more. Circulating tumor (ct)DNA studies using next-generation tagged amplicon sequencing identified early indications of treatment response and mechanistically relevant correlates of clinical drug resistance (e.g., mutations in  KRAS, ERBB2 ) in some patients.
CONCLUSIONS


Taselisib can be safely combined with tamoxifen at the recommended phase 2 dose of 4 mg given once daily on a continuous schedule. Preliminary evidence of antitumor activity was seen in both  PIK3CA  mutant and wild-type cancers. The randomized phase 2 part of POSEIDON (testing tamoxifen plus taselisib or placebo) is currently recruiting.",2019,No dose-limiting toxicities were observed.,"['receptor positive metastatic breast cancer patients', '30 patients with ER-positive, metastatic breast cancer who had failed prior endocrine therapy were treated with']","['tamoxifen', 'PI3K-mTOR inhibition', 'escalating doses of taselisib (2 or 4 mg in an intermittent or continuous schedule) combined with tamoxifen', 'tamoxifen plus taselisib or placebo', 'taselisib combined with tamoxifen']","['No dose-limiting toxicities', 'mucositis', 'safety, efficacy and ctDNA response', 'Median time to disease progression', 'Objective responses', 'tolerated', 'diarrhea', 'hyperglycemia']","[{'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4053731'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",30.0,0.0298478,No dose-limiting toxicities were observed.,"[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Baird', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom. rdb39@cam.ac.uk.'}, {'ForeName': 'Annelot G J', 'Initials': 'AGJ', 'LastName': 'van Rossum', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Beelen', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Schrier', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Mandjes', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Garcia-Corbacho', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Anne-Laure', 'Initials': 'AL', 'LastName': 'Vallier', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Greig', 'Initials': 'G', 'LastName': 'Dougall', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Linossi', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'van Tinteren', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Callari', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Beddowes', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'José-Manuel', 'Initials': 'JM', 'LastName': 'Perez-Garcia', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Rosing', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Platte', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Nederlof', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Schot', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'de Vries Schultink', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Bernards', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gallagher', 'Affiliation': 'University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortès', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Caldas', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, the Netherlands.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0508']
723,31097338,20% Human Albumin Solution Fluid Bolus Administration Therapy in Patients After Cardiac Surgery (the HAS FLAIR Study).,"OBJECTIVE


To compare the effects of fluid bolus therapy using 20% albumin versus crystalloid on fluid balance, hemodynamic parameters, and intensive care unit (ICU) treatment effects in post-cardiac surgery patients.
DESIGN


Sequential period open-label pilot study.
SETTING


University teaching hospital.
PARTICIPANTS


One hundred adult cardiac surgery patients who were prescribed fluid bolus therapy to correct hypotension or perceived hypovolemia or to optimize cardiac index during the first 24 hours in the ICU.
INTERVENTIONS


The first 50 patients were treated with crystalloid fluid bolus therapy in the first period (control), and 50 patients with up to 2 treatments of 100 mL of 20% albumin fluid bolus therapy in the second period (intervention), followed by crystalloid therapy if needed.
MEASUREMENTS AND MAIN RESULTS


Demographic characteristics were similar at baseline. The intervention was associated with a less positive median fluid balance in the first 24 hours (albumin: 1,100 [650-1,960] v crystalloid: 1,970 [1,430-2,550] p = 0.001), fewer episodes of fluid bolus therapy (3 [2-5] v 5 [4-7]; p < 0.0001) and a lesser volume of fluid bolus therapy (700 [200-1,450] v 1,500 mL/24 h [1,100-2,250]; p < 0.0001). The intervention also was associated with a decreased median overall dose of norepinephrine in the first 24 hours of ICU stay (19 [0-52] v 47 µg/kg/24 hours [0-134]; p = 0.025) and shorter median time to cessation of norepinephrine (17 [5-28] v 28 hours [20-48]; p = 0.002).
CONCLUSION


Post-cardiac surgery fluid bolus therapy with 20% albumin when compared with crystalloid fluid resulted in less positive fluid balance as well as several hemodynamic and potential ICU treatment advantages.",2019,"The intervention was associated with a less positive median fluid balance in the first 24 hours (albumin: 1,100 [650-1,960] v crystalloid: 1,970 [1,430-2,550] p = 0.001), fewer episodes of fluid bolus therapy (3 [2-5] v 5 [4-7]; p < 0.0001) and a lesser volume of fluid bolus therapy (700 [200-1,450] v 1,500 mL/24 h [1,100-2,250]; p < 0.0001).","['One hundred adult cardiac surgery patients who were prescribed fluid bolus therapy to correct hypotension or perceived hypovolemia or to optimize cardiac index during the first 24 hours in the ICU', 'Patients', 'post-cardiac surgery patients', 'University teaching hospital']","['albumin versus crystalloid', 'norepinephrine', 'crystalloid fluid bolus therapy']","['episodes of fluid bolus therapy', 'fluid balance, hemodynamic parameters, and intensive care unit (ICU) treatment effects', 'positive median fluid balance', 'median overall dose of norepinephrine', 'positive fluid balance', 'lesser volume of fluid bolus therapy']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance (finding)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",50.0,0.106563,"The intervention was associated with a less positive median fluid balance in the first 24 hours (albumin: 1,100 [650-1,960] v crystalloid: 1,970 [1,430-2,550] p = 0.001), fewer episodes of fluid bolus therapy (3 [2-5] v 5 [4-7]; p < 0.0001) and a lesser volume of fluid bolus therapy (700 [200-1,450] v 1,500 mL/24 h [1,100-2,250]; p < 0.0001).","[{'ForeName': 'Geoffrey J', 'Initials': 'GJ', 'LastName': 'Wigmore', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia. Electronic address: geoffrey.wigmore@mh.org.au.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anstey', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'St John', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Greaney', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Morales-Codina', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Presneill', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Department of Medicine, Royal Melbourne Hospital, Parkville, Australia.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Intensive Care, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre, Melbourne, Victoria, Australia; Department of Medicine and Radiology, University of Melbourne, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tatoulis', 'Affiliation': 'Department of Cardiothoracic Surgery, Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, The Alfred Centre, Melbourne, Victoria, Australia; Department of Intensive Care, Austin Hospital, Heidelberg, Melbourne, Victoria, Australia.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.03.049']
724,31009400,A randomized double-blinded sham-controlled cross-over trial of tined-lead sacral nerve stimulation testing for chronic constipation.,"OBJECTIVES


Sacral nerve stimulation (SNS) may provide long-term symptom relief to patients suffering from chronic constipation. Patients are currently selected for SNS using a 2-week peripheral nerve evaluation (PNE) comprising stimulation by temporary leads. However, only 40% of test responders receive long-term benefit from treatment meaning that healthcare costs per successfully treated patient are too high. The primary objective was to assess tined-lead testing to predict benefit from SNS for chronic constipation.
PATIENTS AND METHODS


A randomized double-blind sham-controlled cross-over design evaluated enhanced PNE (ePNE) using tined quadripolar electrode leads over 6 weeks. The design differentiated between patients with discriminate and indiscriminate responses to testing. A score improvement of 25% or more was considered to be a positive response within a stimulation period. The primary outcome was the proportion of patients showing a reduction of at least 0.5 in constipation symptom score at 6 months.
RESULTS


A total of 45 patients were randomized, of whom 29 (64.4%) were test-phase responders. Of these, 27 were implanted providing permanent SNS. During ePNE, seven (18%) were discriminate responders, 22 (56%) were indiscriminate responders and 10 (26%) were nonresponders. Six patients were withdrawn during the test phase because of infection or noncompliance. At 6 months, there was no significant difference in primary outcome between discriminate and indiscriminate responders (60 vs. 57%, P=0.76). The study was terminated prematurely because of a persistent infection rate of 10 (22%) during ePNE of which nine (20%) were severe.
CONCLUSION


ePNE is a poor predictor of treatment response at 6 months. This suggests a strong and persistent placebo response during both SNS PNE and treatment. An extended 6-week PNE poses a high risk of infection.",2019,"At 6 months, there was no significant difference in primary outcome between discriminate and indiscriminate responders (60 vs. 57%, P=0.76).","['Patients are currently selected for SNS using a 2-week peripheral nerve evaluation (PNE) comprising stimulation by temporary leads', 'chronic constipation', 'patients suffering from chronic constipation', 'A total of 45 patients']","['Sacral nerve stimulation (SNS', 'tined-lead sacral nerve stimulation testing', 'enhanced PNE (ePNE']","['persistent infection rate', 'proportion of patients showing a reduction of at least 0.5 in constipation symptom score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C2609267', 'cui_str': 'Sacral nerve stimulation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.678689,"At 6 months, there was no significant difference in primary outcome between discriminate and indiscriminate responders (60 vs. 57%, P=0.76).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yiannakou', 'Affiliation': 'Departments of Neurogastroenterology.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Etherson', 'Affiliation': 'Department of Colorectal Surgery, North Tees and Hartlepool NHS Foundation Trust, Stockton.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Close', 'Affiliation': 'Institute of Health and Society.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Durham University, Durham.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mercer-Jones', 'Affiliation': 'Department of Colorectal Surgery, Gateshead Health Foundation Trust, Gateshead.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Plusa', 'Affiliation': 'Department of Colorectal Surgery, Newcastle University Teaching Hospitals, Newcastle upon Tyne.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Green', 'Affiliation': 'General and Colorectal Surgery, County Durham and Darlington NHS Foundation Trust.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cundall', 'Affiliation': 'General and Colorectal Surgery, County Durham and Darlington NHS Foundation Trust.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Knowles', 'Affiliation': 'Queen Mary University of London, London.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'Department of Health Economics, Warwick Medical School, Warwick University, Warwick, UK.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001379']
725,31005993,Prediction of the effect of dapagliflozin on kidney and heart failure outcomes based on short-term changes in multiple risk markers.,"BACKGROUND


Besides improving glucose control, sodium-glucose co-transporter 2 inhibition with dapagliflozin reduces blood pressure, body weight and urinary albumin:creatinine ratio (UACR) in patients with type 2 diabetes (T2DM). The parameter response efficacy (PRE) score was developed to predict how short-term drug effects on cardiovascular risk markers translate into long-term changes in clinical outcomes. We applied the PRE score to clinical trials of dapagliflozin to model the effect of the drug on kidney and heart failure (HF) outcomes in patients with T2DM and impaired kidney function.
METHODS


The relationships between multiple risk markers and long-term outcome were determined in a background population of patients with T2DM with a multivariable Cox model. These relationships were then applied to short-term changes in risk markers observed in a pooled database of dapagliflozin trials (n = 7) that recruited patients with albuminuria to predict the drug-induced changes to kidney and HF outcomes.
RESULTS


A total of 132 and 350 patients had UACR >200 mg/g and >30 mg/g at baseline, respectively, and were selected for analysis. The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 mg/g subgroups. The predicted change in risk for HF events was -27.3% (95% CI -47.7 to -5.1) and -21.2% (95% CI -35.0 to -7.8), respectively. Simulation analyses showed that even with a smaller albuminuria-lowering effect of dapagliflozin (10% instead of the observed 35% in both groups), the estimated kidney risk reduction was still 26.5 and 26.8%, respectively.
CONCLUSIONS


The PRE score predicted clinically meaningful reductions in kidney and HF events associated with dapagliflozin therapy in patients with diabetic kidney disease. These results support a large long-term outcome trial in this population to confirm the benefits of the drug on these endpoints.",2020,The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 ,"['patients with type 2 diabetes (T2DM', 'A total of 132 and 350 patients had UACR\u2009>200\u2009mg/g and >30\u2009mg/g at baseline, respectively, and were selected for analysis', 'patients with T2DM and impaired kidney function', 'patients with diabetic kidney disease']","['dapagliflozin therapy', 'placebo', 'dapagliflozin']","['parameter response efficacy (PRE) score', 'multiple risk markers', 'blood pressure, body weight and urinary albumin:creatinine ratio (UACR', 'risk for HF events', 'kidney risk reduction', 'kidney and heart failure (HF) outcomes', 'PRE score predicted a risk change for kidney events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0689993,The PRE score predicted a risk change for kidney events of -40.8% [95% confidence interval (CI) -51.7 to -29.4) and -40.4% (95% CI -48.4 to -31.1) with dapagliflozin 10 mg compared with placebo for the UACR >200 mg/g and >30 ,"[{'ForeName': 'Nienke M A', 'Initials': 'NMA', 'LastName': 'Idzerda', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Bergur V', 'Initials': 'BV', 'LastName': 'Stefansson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Pena', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Sjostrom', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Wheeler', 'Affiliation': 'Department of Renal Medicine, University College London, London, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz064']
726,31878961,Effects of aerobic interval training on glucose tolerance in children and adolescents with cystic fibrosis: a randomized trial protocol.,"BACKGROUND


Individuals with cystic fibrosis (CF) may develop CF-related diabetes (CFDR). This comorbidity is related to a poorer quality of life, microvascular complications, a decline in lung function, and an increase in exacerbations, as well as delayed growth and puberty. Evidence exists that physical exercise contributes to glycemic control in individuals with non-CF-related diabetes. This exercise is usually continuous with moderate intensity and long duration, which can cause muscle dyspnea and fatigue in CF individuals. Aerobic interval training (AIT) emerges as a safe and effective alternative for treating these individuals. The objective of this study is to evaluate the effects of AIT on glucose tolerance in children and adolescents with CF.
METHODS


This study will be a two-arm, prospectively registered, randomized controlled trial with blind assessors and twenty 6- to 18-year-old individuals with cystic fibrosis (CF) from two different Brazilian states. People with CF will be randomly allocated to either the experimental or control group using block randomization, stratified by puberty stage,. Participants from both groups will receive an educational intervention and will be asked to continue their usual daily treatment for the full duration of the study. Those in the experimental group will perform AIT on a cycle ergometer at home three times a week, for 8 consecutive weeks. The sample characterization will include an assessment of puberty stage, socioeconomic status, dyspnea, and anthropometry. The primary outcome will be the change in glucose tolerance, while the secondary outcomes will include lung function, exercise tolerance, respiratory muscle strength, quality of life, and CF exacerbations. All outcomes will be assessed at baseline, week 9, and week 17.
DISCUSSION


This is the first study to evaluate the effects of AIT on glucose tolerance in children and adolescents with CF. This study will serve as a basis for guiding clinical practice and decision-making in treating glucose intolerance and CF-related diabetes (CFRD) in children and adolescents with CF.
TRIAL REGISTRATION


ClinicalTrials.gov Protocol Registration System: NCT03653949. Registered on August 31, 2018.",2019,Participants from both groups will receive an educational intervention and will be asked to continue their usual daily treatment for the full duration of the study.,"['Individuals with cystic fibrosis (CF', 'People with CF', 'twenty 6- to 18-year-old individuals with cystic fibrosis (CF) from two different Brazilian states', 'individuals with non-CF-related diabetes', 'children and adolescents with cystic fibrosis', 'children and adolescents with CF']","['aerobic interval training', 'Aerobic interval training (AIT', 'educational intervention', 'physical exercise', 'AIT']","['lung function, exercise tolerance, respiratory muscle strength, quality of life, and CF exacerbations', 'change in glucose tolerance', 'glucose tolerance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",,0.0942226,Participants from both groups will receive an educational intervention and will be asked to continue their usual daily treatment for the full duration of the study.,"[{'ForeName': 'Karolinne Souza', 'Initials': 'KS', 'LastName': 'Monteiro', 'Affiliation': 'Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil. karolsm@outlook.com.br.'}, {'ForeName': 'Matheus de Paiva', 'Initials': 'MP', 'LastName': 'Azevedo', 'Affiliation': 'Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Lucas Menescal', 'Initials': 'LM', 'LastName': 'Jales', 'Affiliation': 'Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Fernanda Elizabeth Pereira', 'Initials': 'FEP', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Ricardo Fernando', 'Initials': 'RF', 'LastName': 'Arrais', 'Affiliation': 'Department of Pediatrics, Pediatric and Adolescent Unit of University Hospital Prof. Onofre Lopes of Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Karla Morganna Pereira Pinto', 'Initials': 'KMPP', 'LastName': 'de Mendonça', 'Affiliation': 'Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}]",Trials,['10.1186/s13063-019-3803-8']
727,31062455,Examining the effects of computerised cognitive training on levels of executive function in adults with Down syndrome.,"BACKGROUND


Individuals with Down syndrome (DS) are at much greater risk of developing Alzheimer's disease, and one of the early clinical symptoms of Alzheimer's disease is executive dysfunction. In the general population, cognitive training has shown some promising results in relation to maintaining or improving cognitive processes. There is currently a gap in the literature in relation to cognitive training for adults with DS.
METHODS


A quasi-experimental mixed factorial design with partial crossover was used involving an 8-week intervention period using a brain training programme. Participants were matched on age and then randomly assigned to either the intervention group or the delayed intervention group. Forty adults with DS, aged between 30 and 49 and with a mild or moderate level of intellectual disability, participated in the study. All participants completed baseline measures of executive function, using both neuropsychological assessments and an informant-rated measure of behavioural executive function. The intervention group first completed the training and then the delayed intervention group. Executive function assessments were repeated for both groups following the training.
RESULTS


The study aimed to examine whether a cognitive training programme could have an effect on levels of executive function. While conclusions are limited owing to small sample size, improvement was seen in neuropsychological assessments of executive function following cognitive training. Positive effects reflected in everyday behaviours were not as promising.
CONCLUSIONS


This study showed that, while it has not been previously an area of focus, individuals with DS can complete a computerised cognitive training programme. Furthermore, the results were promising with significant improvements found in neuropsychological assessments of executive function. These findings need further investigation with a larger sample size and would benefit from the use of a brain imaging component to strengthen the findings.",2019,"While conclusions are limited owing to small sample size, improvement was seen in neuropsychological assessments of executive function following cognitive training.","['adults with Down syndrome', 'adults with DS', 'Individuals with Down syndrome (DS', 'Forty adults with DS, aged between 30 and 49 and with a mild or moderate level of intellectual disability, participated in the study']","['computerised cognitive training', 'cognitive training programme', 'cognitive training', 'delayed intervention group']","['Executive function assessments', 'everyday behaviours', 'behavioural executive function', 'levels of executive function', 'neuropsychological assessments of executive function', 'executive function']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714756', 'cui_str': 'Intellectual Development Disorder'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",40.0,0.0519556,"While conclusions are limited owing to small sample size, improvement was seen in neuropsychological assessments of executive function following cognitive training.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'McGlinchey', 'Affiliation': 'Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'McCarron', 'Affiliation': 'Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holland', 'Affiliation': 'Cambridge Intellectual & Development Disabilities Research Group (CIDDRG), University of Cambridge, Cambridge, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'McCallion', 'Affiliation': 'School of Social Work, Temple University, Philadelphia, PA, USA.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12626']
728,31033625,Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial.,"BACKGROUND


Major lumbar spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study was to compare the effect of ultrasound (US)-guided erector spinae plane (ESP) block on 24-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia. Postoperative pain control and patient satisfaction were also assessed.
MATERIALS AND METHODS


Adults scheduled for elective lumbar spine surgery under general anesthesia were randomly assigned to the following (and they are): Control group-no preoperative ESP block, or ESP block group-preoperative bilateral US-guided ESP block. Both groups received standard general anesthesia during surgery. Postoperative pain score, number of patients requiring rescue analgesia, and total morphine consumption during the first 24 postoperative hours were recorded. Patient satisfaction was assessed 24 hours after surgery.
RESULTS


Postoperative morphine consumption was significantly lower in patients in the ESP group compared with those in the control group (1.4±1.5 vs. 7.2±2.0 mg, respectively; P<0.001). All patients in the control group required supplemental morphine compared with only 9 (45%) in the ESP block group (P=0.002). Pain scores immediately after surgery (P=0.002) and at 6 hours after surgery (P=0.040) were lower in the ESP block group compared with the control group. Patient satisfaction scores were more favorable in the block group (P<0.0001).
CONCLUSIONS


US-guided ESP block reduces postoperative opioid requirement and improves patient satisfaction compared with standard analgesia in lumbar spine surgery patients.",2020,"CONCLUSIONS


US-guided ESP block reduces postoperative opioid requirement and improves patient satisfaction compared with standard analgesia in lumbar spine surgery patients.","['lumbar spine surgery patients', 'Lumbar Spine Surgery', 'Adults scheduled for elective lumbar spine surgery under general anesthesia', 'Major lumbar spine surgery causes severe postoperative pain']","['ultrasound (US)-guided erector spinae plane (ESP) block', 'supplemental morphine', 'Control group-no preoperative ESP block, or ESP block group-preoperative bilateral US-guided ESP block', 'standard general anesthesia', 'Bilateral Ultrasound-guided Erector Spinae Plane Block', 'ESP', 'standard (opioid-based) analgesia', 'US-guided ESP block']","['Postoperative pain control and patient satisfaction', 'Postoperative morphine consumption', 'Patient satisfaction', 'Postoperative pain score, number of patients requiring rescue analgesia, and total morphine consumption', 'Pain scores', 'Patient satisfaction scores', 'patient satisfaction']","[{'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}]",,0.183817,"CONCLUSIONS


US-guided ESP block reduces postoperative opioid requirement and improves patient satisfaction compared with standard analgesia in lumbar spine surgery patients.","[{'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesia and Critical Care, Postgraduate Institute of Medical Education and Research, Chandigarh, Punjab.'}, {'ForeName': 'Neeraj K', 'Initials': 'NK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anaesthesia and Critical Care, Patna Medical College and Hospital, Patna, Bihar.'}, {'ForeName': 'Dusu', 'Initials': 'D', 'LastName': 'Lalin', 'Affiliation': 'Indira Gandhi Institute of Medical Sciences.'}, {'ForeName': 'Vinod K', 'Initials': 'VK', 'LastName': 'Verma', 'Affiliation': 'Department of Anaesthesia, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000603']
729,31002147,Single nucleotide polymorphisms at the ADIPOQ gene locus rs1501299 interact with different type of dietary fatty acids in two hypocaloric diets.,"OBJECTIVE


Some adiponectin gene (ADIPOQ) and single nucleotide polymorphisms (SNPs) have been related to adiponectin levels and metabolic parameters. Few studies of interaction gene-nutrient have been realized in this topic area. The aim of our study was to analyze the effect of the rs1501299 ADIPOQ gene polymorphism, and the dietary intake on total adiponectin levels and the insulin resistance changes after an enriched-monounsaturated fat (Diet M) vs. an enriched-polyunsaturated fat hypocaloric diet (Diet P).
PATIENTS AND METHODS


A Caucasian population of 363 obese patients was enrolled in a randomized clinical trial with two hypocaloric diets. Before and after 12 weeks on each hypocaloric diet, an anthropometric evaluation, an assessment of nutritional intake and a biochemical analysis were realized. The statistical analysis was performed for the combined GT and TT as a group (mutant) and GG as second group (wild).
RESULTS


With both caloric restriction strategies, body weight, body mass index (BMI), fat mass, waist circumference, systolic blood pressure and leptin levels decreased. After Diet P, only subjects with GG genotype showed a significant improvement in the insulin levels (GG vs. GT±TT) (-3.2±1.0 mU/L vs. -0.6±0.4 mU/L: p=0.01) and in the homeostasis model assessment (HOMA-IR) (-1.1±0.2 units vs. -0.3±0.4 units: p=0.02). The same improvement in both parameters was reported after Diet M: insulin levels (-3.7±0.9 mU/L vs. -0.4±0.5 mU/L: p=0.01) and HOMA-IR (-1.0±0.2 units vs. -0.4±0.3 units: p=0.03). After weight loss with diet M, both genotypes (GG vs. GT±TT) showed similar decrease in total cholesterol and LDL-cholesterol. Only subjects with GG genotype showed a significant increase of the adiponectin levels after both diets: (Diet P: 9.3±3.0 ng/dl vs. Diet M: 8.2±2.9 ng/dl: p=0.38).
CONCLUSIONS


The GG genotype of ADIPOQ gene variant (rs1501299) is associated to a significant improvement in the adiponectin levels and a decrease of insulin and HOMA-IR after two different hypocaloric diets with different profile of unsaturated dietary fats.",2019,The GG genotype of ADIPOQ gene variant (rs1501299) is associated to a significant improvement in the adiponectin levels and a decrease of insulin and HOMA-IR after two different hypocaloric diets with different profile of unsaturated dietary fats.,['A Caucasian population of 363 obese patients'],['enriched-monounsaturated fat (Diet M) vs. an enriched-polyunsaturated fat hypocaloric diet (Diet P'],"['insulin and HOMA-IR', 'total cholesterol and LDL-cholesterol', 'body weight, body mass index (BMI), fat mass, waist circumference, systolic blood pressure and leptin levels', 'adiponectin levels', 'homeostasis model assessment (HOMA-IR) ', 'total adiponectin levels', 'insulin levels (GG vs. GT±TT', 'HOMA-IR']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2362517', 'cui_str': 'Monounsaturated fat (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2362518', 'cui_str': 'Polyunsaturated fat (substance)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]",363.0,0.0296689,The GG genotype of ADIPOQ gene variant (rs1501299) is associated to a significant improvement in the adiponectin levels and a decrease of insulin and HOMA-IR after two different hypocaloric diets with different profile of unsaturated dietary fats.,"[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'de Luis', 'Affiliation': 'Center of Investigation of Endocrinology and Nutrition, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. dadluis@yahoo.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_201904_17577']
730,31035808,Perceived cancer-related benefits of quitting smoking and associations with quit intentions among recently diagnosed cancer patients.,"One third of smokers diagnosed with cancer continue smoking, perhaps due to low perceived cancer-related benefits of cessation. To examine perceived cancer-related benefits of quitting among newly diagnosed cancer patients who smoke and associations with quit intentions, baseline measures from patients (N = 303) enrolled in a randomized controlled trial were analyzed using hierarchical regression models and bootstrapping. Higher perceived cancer-related benefits of quitting were associated with having a smoking-related cancer and less education. Perceived cancer-related benefits of quitting and quit intentions were positively correlated, particularly among patients with smoking-related cancers. For smokers with smoking-related cancers, perceived cancer-related benefits of quitting are correlated with quit intentions.",2019,"Perceived cancer-related benefits of quitting and quit intentions were positively correlated, particularly among patients with smoking-related cancers.","['newly diagnosed cancer patients who smoke and associations with quit intentions, baseline measures from patients (N\u2009=\u2009303', 'diagnosed cancer patients']",[],['Perceived cancer-related benefits of quitting and quit intentions'],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0449770', 'cui_str': 'Measured from (attribute)'}]",[],"[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",303.0,0.0755629,"Perceived cancer-related benefits of quitting and quit intentions were positively correlated, particularly among patients with smoking-related cancers.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Neil', 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': '3 Memorial Sloan Kettering Cancer Center, USA.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Hawari', 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': '1 Massachusetts General Hospital, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': '1 Massachusetts General Hospital, USA.'}]",Journal of health psychology,['10.1177/1359105319845131']
731,31715582,Individualized Training Based on Force-Velocity Profiling During Jumping in Ballet Dancers.,"PURPOSE


Ballet dancers are required to achieve performance feats such as exciting and dramatic elevations. Dancers with a greater jump height can perform a wider range of skills during their flight time and implement more specific technical skills related to the aesthetic components of a dance choreography. New findings suggest the relationship between force and velocity mechanical capabilities (F-V profile) as an important variable for jumping performance. A new field method based on several series of loaded vertical jumps provides information on the theoretical maximal force, theoretical maximal velocity, theoretical maximal power, and the imbalance between force and velocity (F-VIMB). The purpose of this study was to observe the effects of 9 wk of individualized F-V profile-based training during countermovement jumps (CMJs) in female ballet dancers.
METHODS


CMJ and mechanical outputs of 46 dancers (age = 18.9 [1.1] y, body mass = 54.8 [6.1] kg, height = 163.7 [8.4] cm) were estimated in a pre-post intervention. The control group (10 participants) continued with the standardized training regimen (no resistance training), whereas the experimental group (36 participants) performed 2 sessions over 9 wk of a training plan based on their F-V profile.
RESULTS


The experimental group presented significant differences with large effect sizes in CMJ height (29.3 [3.2] cm vs 33.5 [3.72] cm), theoretical maximal force (24.1 [2.2] N/kg vs 29.9 [2.8] N/kg), and theoretical maximal velocity (4 [0.6] m/s vs 3.2 [0.5] m/s). Significant differences with a very large effect size were found in F-VIMB (43.8% [15.3%] vs 24.9% [8.7%]).
CONCLUSION


A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.",2020,A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.,"['female ballet dancers', '46 dancers (age ']","['individualized F-V profile-based training during countermovement jumps (CMJs', 'standardized training regimen (no resistance training', 'Individualized Training Based on Force-Velocity Profiling']","['theoretical maximal force', 'F-VIMB', 'CMJ height']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0871967', 'cui_str': 'Ballet'}, {'cui': 'C0335081', 'cui_str': 'Dancer (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]",36.0,0.0246706,A training program addressing F-VIMB is an effective way to improve CMJ height in female ballet dancers.,"[{'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Escobar Álvarez', 'Affiliation': ''}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Fuentes García', 'Affiliation': ''}, {'ForeName': 'Filipe A', 'Initials': 'FA', 'LastName': 'Da Conceição', 'Affiliation': ''}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez-Reyes', 'Affiliation': ''}]",International journal of sports physiology and performance,"['10.1123/ijspp.2019-0492', '10.1123/ijspp.2019-0492']"
732,31714986,Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial.,"Importance


Additional treatment options are needed for patients who do not achieve sufficient reduction in low-density lipoprotein cholesterol (LDL-C) level with available lipid-lowering therapies.
Objective


To assess the efficacy of bempedoic acid vs placebo in patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy.
Design, Setting, and Participants


Phase 3, randomized, double-blind, placebo-controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018. A total of 779 patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both met randomization criteria, which included LDL-C level 70 mg/dL (1.8 mmol/L) or greater while receiving maximally tolerated lipid-lowering therapy.
Interventions


Patients were randomized 2:1 to treatment with bempedoic acid (180 mg) (n = 522) or placebo (n = 257) once daily for 52 weeks.
Main Outcomes and Measures


The primary end point was percent change from baseline in LDL-C level at week 12. Secondary measures included changes in levels of lipids, lipoproteins, and biomarkers.
Results


Among 779 randomized patients (mean age, 64.3 years; 283 women [36.3%]), 740 (95.0%) completed the trial. At baseline, mean LDL-C level was 120.4 (SD, 37.9) mg/dL. Bempedoic acid lowered LDL-C levels significantly more than placebo at week 12 (-15.1% vs 2.4%, respectively; difference, -17.4% [95% CI, -21.0% to -13.9%]; P < .001). Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04). Common adverse events included nasopharyngitis (5.2% vs 5.1% with bempedoic acid and placebo, respectively), urinary tract infection (5.0% vs 1.9%), and hyperuricemia (4.2% vs 1.9%).
Conclusions and Relevance


Among patients at high risk for cardiovascular disease receiving maximally tolerated statins, the addition of bempedoic acid compared with placebo resulted in a significant lowering of LDL-C level over 12 weeks. Further research is needed to assess the durability and clinical effect as well as long-term safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02991118.",2019,"Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04).","['Patients at High Risk for Cardiovascular Disease', '779 patients with atherosclerotic cardiovascular disease, heterozygous familial hypercholesterolemia, or both met randomization criteria, which included LDL-C level 70 mg/dL (1.8 mmol/L) or greater while receiving maximally tolerated lipid-lowering therapy', '779 randomized patients (mean age, 64.3 years; 283 women [36.3%]), 740 (95.0%) completed the trial', 'patients at high risk for cardiovascular disease receiving maximally tolerated statins', 'patients at high cardiovascular risk receiving maximally tolerated lipid-lowering therapy', 'controlled clinical trial conducted at 91 clinical sites in North America and Europe from November 2016 to September 2018, with a final date of follow-up of September 22, 2018']","['placebo', 'Bempedoic Acid vs Placebo', 'bempedoic acid vs placebo', 'bempedoic acid']","['high-sensitivity C-reactive protein', 'urinary tract infection', 'hyperuricemia', 'apolipoprotein B', 'changes in levels of lipids, lipoproteins, and biomarkers', 'Low-Density Lipoprotein Cholesterol', 'low-density lipoprotein cholesterol (LDL-C) level', 'LDL-C level', 'total cholesterol', 'density lipoprotein cholesterol', 'mean LDL-C level', 'nasopharyngitis', 'LDL-C levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous (disorder)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",779.0,0.807018,"Significant reductions with bempedoic acid vs placebo were observed at week 12 for non-high-density lipoprotein cholesterol (-10.8% vs 2.3%; difference, -13.0% [95% CI, -16.3% to -9.8%]; P < .001), total cholesterol (-9.9% vs 1.3%; difference, -11.2% [95% CI, -13.6% to -8.8%]; P < .001), apolipoprotein B (-9.3% vs 3.7%; difference, -13.0% [95% CI, -16.1% to -9.9%]; P < .001), and high-sensitivity C-reactive protein (median, -18.7% vs -9.4%; difference, -8.7% [asymptotic confidence limits, -17.2% to -0.4%]; P = .04).","[{'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Seth J', 'Initials': 'SJ', 'LastName': 'Baum', 'Affiliation': 'Preventive Cardiology Inc, Boca Raton, Florida.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Hanselman', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'LeAnne T', 'Initials': 'LT', 'LastName': 'Bloedon', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Narendra D', 'Initials': 'ND', 'LastName': 'Lalwani', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Pragna M', 'Initials': 'PM', 'LastName': 'Patel', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'P Barton', 'Initials': 'PB', 'LastName': 'Duell', 'Affiliation': 'Center for Preventive Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland.'}]",JAMA,['10.1001/jama.2019.16585']
733,31878966,Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial.,"BACKGROUND


Psychotic experiences, social functioning and general psychopathology are important targets for early intervention in individuals with Ultra-High-Risk state (UHR) and a first-episode psychosis (FEP). Acceptance and Commitment Therapy (ACT) is a promising, next-generation Cognitive Behavioural Therapy (CBT) that aims to modify these targets, but evidence on sustainable change and its underlying mechanisms in individuals' daily lives remains limited. The aim of the INTERACT study is to investigate the efficacy of a novel ecological momentary intervention, Acceptance and Commitment Therapy in Daily Life (ACT-DL) in a multi-centre randomised controlled trial of individuals with UHR or FEP.
METHODS/DESIGN


In a multi-centre randomised controlled trial, individuals aged 16-65 years with UHR or FEP will be randomly allocated to ACT-DL in addition to treatment as usual (TAU) as the experimental condition or a control condition of TAU only, which will include - for the entire study period - access to routine mental health care and, where applicable, CBT for psychosis (CBTp). Outcomes will be assessed at baseline (i.e. before randomisation), post-intervention (i.e. after the 8-week intervention period), and 6-month and 12-month follow-ups (i.e. 6 and 12 months after completing the intervention period) by blinded assessors. The primary outcome will be distress associated with psychotic experiences, while secondary outcomes will include (momentary) psychotic experiences, social functioning and psychopathology. Process measures to assess putative mechanisms of change will include psychological flexibility, stress sensitivity and reward experiences. In addition, acceptability, treatment adherence and treatment fidelity of ACT-DL will be assessed.
DISCUSSION


The current study is the first to test the efficacy of ACT-DL in individuals with UHR and FEP. If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services.
TRIAL REGISTRATION


Netherlands Trial Register, ID: NTR4252. Registered on 26 September 2013.",2019,"If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services.
","['individuals with UHR or FEP', 'individuals with UHR and FEP', 'individuals with Ultra-High-Risk state (UHR) and a first-episode psychosis (FEP', 'early psychosis', 'individuals aged 16-65 years with UHR or FEP']","['novel ecological momentary intervention, Acceptance and Commitment Therapy in Daily Life (ACT-DL', 'ACT-DL', 'Acceptance and Commitment Therapy (ACT', 'Acceptance and Commitment Therapy']","['psychological flexibility, stress sensitivity and reward experiences', 'distress associated with psychotic experiences, while secondary outcomes will include (momentary) psychotic experiences, social functioning and psychopathology', 'acceptability, treatment adherence and treatment fidelity of ACT-DL']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.257101,"If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services.
","[{'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Reininghaus', 'Affiliation': 'Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany. ulrich.reininghaus@zi-mannheim.de.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Klippel', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Steinhart', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vaessen', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'van Nierop', 'Affiliation': 'Department of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Viechtbauer', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Batink', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Kasanova', 'Affiliation': 'Department of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'van Aubel', 'Affiliation': 'Department of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'van Winkel', 'Affiliation': 'Universitair Psychiatrisch Centrum KU Leuven, Kortenberg, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Gaag', 'Affiliation': 'Department of Clinical Psychology, VU Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lieuwe', 'Initials': 'L', 'LastName': 'de Haan', 'Affiliation': 'Department of Psychiatry, University of Amstderdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Myin-Germeys', 'Affiliation': 'Department of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.'}]",Trials,['10.1186/s13063-019-3912-4']
734,31816096,Endoscopic Versus Microscopic Management of Attic Cholesteatoma: A Randomized Controlled Trial.,"OBJECTIVES


To compare endoscopic transcanal approach to attic cholesteatoma with conventional microscopic transcanal technique METHODS: Seventy-eight patients diagnosed with attic cholesteatoma were randomly assigned into two groups-one undergoing endoscopic approach and the other microscopic technique. The two groups were compared in terms of area of exposure, access to hidden areas in terms of Middle Ear Structural Visibility Index (MESVI), intraoperative time, postoperative pain, vertigo, long-term hearing, and surgical outcomes.
RESULTS


The mean area of exposure in endoscopic atticotomy required was less than that in microscopic group and was found to be statistically significant. The median MESVI for endoscopic group better than that for microscopic group (P < .0001). The mean operating time in endoscopic approach was less than that in case of microscopic approach, with P < .05. The median postoperative pain score in the endoscopic group was less than that in microscopic group (P < .05). No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure. When long-term surgical outcomes were assessed at 1 year, in endoscopic group, one patient had disease recurrence, one cartilage displacement, one perforation, and two had retraction pocket formation. In the microscopic group, two patients had recurrence, four cartilage displacement, one perforation, and five retraction pocket formation.
CONCLUSION


Endoscopic management of limited attic cholesteatoma has definite advantages over the conventional microscopic approach.
LEVEL OF EVIDENCE


1 Laryngoscope, 130:2461-2466, 2020.",2020,No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure.,"['Attic Cholesteatoma', ' Seventy-eight patients diagnosed with attic cholesteatoma']","['endoscopic approach and the other microscopic technique', 'endoscopic transcanal approach to attic cholesteatoma with conventional microscopic transcanal technique']","['vertigo', 'disease recurrence, one cartilage displacement, one perforation, and two had retraction pocket formation', 'median MESVI', 'mean area of exposure in endoscopic atticotomy', 'Middle Ear Structural Visibility Index (MESVI), intraoperative time, postoperative pain, vertigo, long-term hearing, and surgical outcomes', 'median postoperative pain score', 'mean operating time in endoscopic approach']","[{'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0241518', 'cui_str': 'Retraction of tympanic membrane (finding)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0198106', 'cui_str': 'Atticotomy of ear (procedure)'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",78.0,0.0610664,No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure.,"[{'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Sandipta', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Ghosh', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Arunabha', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Laryngoscope,['10.1002/lary.28446']
735,32410819,Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine.,"Purpose


A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women.
Methods


The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications.
Results


Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples.
Conclusion


The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.",2020,"No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed.","['07 February 2017', 'Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine', 'healthy women']","['Econazole, benzydamine', '150\u2009mg of econazole with 6\u2009mg of benzydamine', 'placebo']","['Safety and tolerability', 'Pruritus and pain', 'adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs', 'Very low econazole, benzydamine, and benzydamine-N-oxide concentrations', 'laboratory parameters, vital signs, body weight, vaginal pH, or ECG', 'overall tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C2718098', 'cui_str': 'Ovule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}]","[{'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0013547', 'cui_str': 'Econazole'}, {'cui': 'C0005099', 'cui_str': 'Benzydamine'}, {'cui': 'C0081742', 'cui_str': 'benzydamine N-oxide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.138482,"No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed.","[{'ForeName': 'A F D', 'Initials': 'AFD', 'LastName': 'Di Stefano', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Radicioni', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vaccani', 'Affiliation': 'CROSS Research S.A., Via F. A. Giorgioli, 14, CH-6864 Arzo, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Caccia', 'Affiliation': 'Service for Gynaecology and Obstetrics, Ospedale Regionale di Mendrisio, Mendrisio, Switzerland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Focanti', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Salvatori', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pelacchi', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Olivieri', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bovi', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': 'Angelini S.p.A., S. Palomba, Rome, Italy.'}]",Infectious diseases in obstetrics and gynecology,['10.1155/2020/7201840']
736,30939081,Effects of guided mindfulness meditation on anxiety and stress in a pre-healthcare college student population: a pilot study.,"Objective:  To identify the effects of guided mindfulness meditation on anxiety and stress in pre-healthcare college students.  Participants : Students ( n  = 33, age 19-22 years) were tested between September and November of 2017.  Methods : Students completed 5-12 minutes of meditation 6 days/week for 8 weeks. We examined differences in pre- and post-intervention stress, anxiety, mindfulness, and heart rate variability.  Results : All variables significantly improved after the intervention. When broken into quartiles based on minutes of meditation, groups 1 (0-184 min,  p  = 0.044) and 2 (184.1-268 min,  p  = 0.042) significantly increased mindfulness after the intervention. Group 3 (268-350 min) significantly decreased state anxiety ( p  = 0.015) and increased mindfulness ( p  = 0.029). Group 4 (350.24-424.05 min) decreased stress ( p  = 0.003), state anxiety ( p  = 0.007), trait anxiety ( p  = 0.003), and increased mindfulness ( p  = 0.007).  Conclusion : Five to twelve minutes of daily mindfulness meditation is associated with decreased stress and anxiety, and increased mindfulness with greater changes observed following more minutes of meditation.",2020,"Group 4 (350.24-424.05 min) decreased stress (p = 0.003), state anxiety (p = 0.007), trait anxiety (p = 0.003), and increased mindfulness (p = 0.007).
CONCLUSION


","['33, age 19-22\u2009years) were tested between September and November of 2017', 'a pre-healthcare college student population', 'Students (n\u2009', 'Students completed 5-12\u2009minutes of meditation 6\u2009days/week for 8\u2009weeks', 'pre-healthcare college students']",['guided mindfulness meditation'],"['trait anxiety', 'pre- and post-intervention stress, anxiety, mindfulness, and heart rate variability', 'anxiety and stress', 'state anxiety', 'stress', 'stress and anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0150277'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0273303,"Group 4 (350.24-424.05 min) decreased stress (p = 0.003), state anxiety (p = 0.007), trait anxiety (p = 0.003), and increased mindfulness (p = 0.007).
CONCLUSION


","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Burgstahler', 'Affiliation': ""Exercise Science and Sport Studies, College of St. Benedict and St. John's University, St. Joseph, MN, USA.""}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Stenson', 'Affiliation': ""Exercise Science and Sport Studies, College of St. Benedict and St. John's University, St. Joseph, MN, USA.""}]",Journal of American college health : J of ACH,['10.1080/07448481.2019.1590371']
737,30961424,Effects of a short video feedback intervention on enhancing maternal sensitivity and infant development in low-income families.,"This study evaluated the effects of a short video feedback intervention aimed at enhancing maternal sensitivity and the development of infants from low-income families in a randomized controlled trial. Forty-four mother-infant dyads living in low-income communities from Salvador, Brazil were randomly assigned between intervention and control groups. Maternal sensitivity was assessed during free-play and infant development was evaluated with a standardized scale. Intervention took place in eight home visits between the infant's third and tenth month. Results showed mothers in the intervention group interpreted the meaning of their infants' behavior more often (r = 0.33), asked babies more questions (r = 0.39), and were less intrusive (r = 0.47) when compared to controls on posttest. The absence of significant intervention effects on infant development suggests the need for additional intervention strategies and a greater time lag between maternal sensitivity and infant development assessments to detect possible delayed effects.",2020,"Results showed mothers in the intervention group interpreted the meaning of their infants' behavior more often (r = 0.33), asked babies more questions (r = 0.39), and were less intrusive (r = 0.47) when compared to controls on posttest.","['infants from low-income\xa0families', 'low-income families', 'Forty-four\xa0mother-infant dyads living in low-income\xa0communities from Salvador, Brazil']",['short video feedback intervention'],"['maternal sensitivity and infant development', 'Maternal sensitivity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}]",44.0,0.0368303,"Results showed mothers in the intervention group interpreted the meaning of their infants' behavior more often (r = 0.33), asked babies more questions (r = 0.39), and were less intrusive (r = 0.47) when compared to controls on posttest.","[{'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Alvarenga', 'Affiliation': 'Institute of Psychology, Federal University of Bahia , Salvador, Brazil.'}, {'ForeName': 'Maria Ángeles', 'Initials': 'MÁ', 'LastName': 'Cerezo', 'Affiliation': 'Department of Basic Psychology, University of Valencia , Valencia, Spain.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wiese', 'Affiliation': 'University College Roosevelt, Utrecht University , Middelburg, The Netherlands.'}, {'ForeName': 'Cesar Augusto', 'Initials': 'CA', 'LastName': 'Piccinini', 'Affiliation': 'Institute of Psychology, Federal University of Rio Grande do Sul , Porto Alegre, Brazil.'}]",Attachment & human development,['10.1080/14616734.2019.1602660']
738,30895697,A trial to evaluate the effect of the sodium-glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF).,"BACKGROUND


Sodium-glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown.
DESIGN AND METHODS


The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF) is an international, multicentre, parallel group, randomized, double-blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N-terminal pro B-type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m 2  . The trial is event-driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes. A total of 4744 patients have been randomized.
CONCLUSIONS


DAPA-HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.",2019,"Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes.","['individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease', 'patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF', '4744 patients have been randomized', 'patients with heart failure and reduced ejection fraction', 'Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N-terminal pro B-type natriuretic peptide level, and an estimated glomerular filtration rate ≥', 'individuals with established heart failure (with or without diabetes', 'patients with chronic heart failure']","['Sodium-glucose co-transporter 2 (SGLT2) inhibitors', 'sodium-glucose co-transporter 2 inhibitor dapagliflozin', 'placebo', 'SGLT2 inhibitors', 'dapagliflozin']","['composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes', 'worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death', 'morbidity and mortality', 'heart failure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3811844'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",4744.0,0.449577,"Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes.","[{'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1432']
739,30928284,The Effect of Simultaneous Renal Replacement Therapy on Extracorporeal Membrane Oxygenation Support for Postcardiotomy Patients with Cardiogenic Shock: A Pilot Randomized Controlled Trial.,"OBJECTIVE


The objectives of this study were to determine the feasibility and safety of simultaneous renal replacement therapy (RRT) during extracorporeal membrane oxygenation (ECMO) support for postcardiotomy patients with cardiogenic shock and whether simultaneous RRT with ECMO would improve survival and reduce morbidity. The authors hypothesized that simultaneous RRT could facilitate effective fluid management and rapid metabolic control in postcardiotomy patients with cardiogenic shock who were undergoing ECMO support.
DESIGN


A parallel, open-label, single-center pilot randomized trial.
SETTING


University-affiliated cardiac surgery intensive care unit.
PARTICIPANTS


The study comprised 41 postcardiotomy patients with cardiogenic shock who received ECMO support.
INTERVENTIONS


Participants were enrolled and randomly assigned via a 1:1 allocation to a simultaneous RRT arm versus a standard care arm. The patients in the simultaneous RRT arm received RRT within 12 hours of the start of ECMO regardless of the conventional RRT indication. Simultaneous RRT was delivered with the RRT machine connected to the ECMO circuit. The patients in the standard care arm did not receive RRT at the start of ECMO unless the conventional RRT indications were fulfilled.
MEASUREMENTS AND MAIN RESULTS


All 41 patients enrolled were followed-up for 30 days and the results analyzed. The primary feasibility outcome was the time from randomization to simultaneous RRT of <12 hours in the simultaneous RRT arm. All participants in simultaneous RRT arm fulfilled with a median time from randomization to simultaneous RRT of 4.4 (2.7-5.6) hours. The 30-day all-cause mortality was 61.9% in the simultaneous RRT arm and 75.0% in the standard care arm (p = 0.51). The lactate clearance was higher in the simultaneous RRT arm (0.56 ± 0.4 v 0.28 ± 0.4 mmol/L/h; p = 0.04). There was lower cumulative fluid balance in the simultaneous RRT arm on ECMO day 3 (-1,510 [-3560 to 1,162] v -332 [-2,027 to 2,181]; p = 0.38) and ECMO day 5 (-2,671 [-5,197 to 3,334] v -1,509 [-3,595 to 1,162]; p = 0.41) without significance. There were no significant differences in adverse events reported and no hemodynamic instability owing to simultaneous RRT delivery.
CONCLUSIONS


This pilot study suggests the feasibility and safety of simultaneous RRT during ECMO support for postcardiotomy patients with cardiogenic shock, providing an efficient means for controlling fluid status and metabolics. A large trial based on this pilot study is required to confirm the clinical benefits.",2019,The lactate clearance was higher in the simultaneous RRT arm (0.56 ± 0.4 v 0.28 ± 0.4 mmol/L/h; p = 0.04).,"['postcardiotomy patients with cardiogenic shock who were undergoing ECMO support', 'postcardiotomy patients with cardiogenic shock', 'University-affiliated cardiac surgery intensive care unit', '41 postcardiotomy patients with cardiogenic shock who received ECMO support', 'Postcardiotomy Patients with Cardiogenic Shock']","['extracorporeal membrane oxygenation (ECMO', 'ECMO', 'Simultaneous Renal Replacement Therapy', 'RRT', 'simultaneous RRT arm versus a standard care arm', 'simultaneous RRT', 'simultaneous renal replacement therapy (RRT']","['survival and reduce morbidity', 'adverse events', 'cumulative fluid balance', '30-day all-cause mortality', 'lactate clearance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036980', 'cui_str': 'Shock, Cardiogenic'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0015357', 'cui_str': 'ECLS Treatment'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016284', 'cui_str': 'Fluid Balance'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",41.0,0.0999134,The lactate clearance was higher in the simultaneous RRT arm (0.56 ± 0.4 v 0.28 ± 0.4 mmol/L/h; p = 0.04).,"[{'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Jia', 'Affiliation': 'Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: xt.hou@ccmu.edu.cn.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.02.031']
740,30930140,"Intravenous Iron Versus Placebo in the Management of Postoperative Functional Iron Deficiency Anemia in Patients Undergoing Cardiac Valvular Surgery: A Prospective, Single-Blinded, Randomized Controlled Trial.","OBJECTIVE


To compare the efficacy of intravenous iron versus placebo to correct postoperative functional iron deficiency anemia in patients undergoing cardiac valvular surgery.
DESIGN


A prospective, single-blinded, randomized controlled study.
SETTING


National Center for Cardiovascular Diseases and a university hospital.
PARTICIPANTS


The study comprised 150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery.
INTERVENTIONS


The patients were randomly assigned (1:1) to either the treatment (intravenous iron) group or the control (placebo) group.
MEASUREMENTS AND MAIN RESULTS


The hemoglobin and ferritin concentrations and postoperative adverse events were collected and compared between the 2 groups. The hemoglobin concentration and the proportion of patients who had their anemia corrected or achieved hemoglobin increments of >20 g/L in the intravenous iron group were significantly higher than that in the placebo group at postoperative day 14 (p = 0.023, p = 0.037, and p = 0.001), whereas there was no statistical difference at postoperative day 7. The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001). There were no significant differences in rates of death, blood tranfusion, antibiotic upgrade, ventilator time >24 hours, postoperative hospital stay >10 days, poor wound healing, and perivalvular leakage between the 2 groups.
CONCLUSIONS


Intravenous iron could significantly increase the hemoglobin level in patients with postoperative functional iron deficiency anemia at postoperative day 14. However, there is no difference in blood transfusion requirements or postoperative adverse outcomes between the 2 groups.",2019,The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001).,"['patients undergoing cardiac valvular surgery', 'Undergoing Cardiac Valvular Surgery', 'patients with postoperative functional iron deficiency anemia at postoperative day 14', 'Patients', '150 patients with postoperative functional iron deficiency anemia after cardiac valvular surgery', 'National Center for Cardiovascular Diseases and a university hospital']","['Intravenous Iron Versus Placebo', 'treatment (intravenous iron) group or the control (placebo', 'placebo', 'intravenous iron versus placebo']","['Postoperative Functional Iron Deficiency Anemia', 'hemoglobin concentration', 'postoperative hospital stay ', 'blood transfusion requirements or postoperative adverse outcomes', 'anemia corrected or achieved hemoglobin increments', 'hemoglobin and ferritin concentrations and postoperative adverse events', 'rates of death, blood tranfusion, antibiotic upgrade, ventilator time', '10days, poor wound healing, and perivalvular leakage', 'ferritin concentration', 'hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005768'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",150.0,0.390836,The ferritin concentration was substantially higher at postoperative day 7 and postoperative day 14 in the intravenous iron group compared with the placebo group (both p < 0.001).,"[{'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yabing', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hengchao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hansong', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Adult Cardiac Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Science, Peking Union Medical College, Beijing, China. Electronic address: drsunhs@sina.com.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.01.063']
741,31712711,Correlation between blood pressure variability and subclinical target organ damage in patients with essential hypertension.,"High blood pressure (BP) variability is associated with the increased risk of cardiovascular and renal damage together with increased cardiovascular mortality. The aim of our study was to investigate the relationship between BP variability and subclinical target organ damage (TOD) in patients with controlled essential hypertension. One hundred patients with controlled essential hypertension were randomly selected from outpatient clinic of Beni-Suef University hospital. All patients were subjected to full history taking, physical examination, three separate office BP measurements for assessment of long-term BP variability, ambulatory BP monitoring for short-term variability, and finally different investigations for subclinical TOD. We had 73 patients with subclinical TOD. Long-term visit-to-visit variability was evaluated by measuring SD (standard deviation) and CV (coefficient of variance) of systolic and diastolic BP. None of the parameters of long-term BP variability were significantly higher among patients with TOD compared with those without TOD. For short-term variability evaluated by ambulatory BP monitoring, average real variability (ARV) was the only parameter that had a significant consistent association with TOD in contrast to SD and CV. Finally, Daytime systolic ARV, nighttime diastolic ARV, and age were independent predictors of TOD (P values = 0.014, 0.018, 0.047, and 0.02, respectively). We concluded that ARV could be an appropriate index of BP variability and a more useful predictor of TOD in contrast to other parameters of BP variability.",2020,None of the parameters of long-term BP variability were significantly higher among patients with TOD compared with those without TOD.,"['patients with essential hypertension', 'patients with controlled essential hypertension', '73 patients with subclinical TOD', 'One hundred patients with controlled essential hypertension were randomly selected from outpatient clinic of Beni-Suef University hospital']",['ARV'],"['High blood pressure (BP) variability', 'Daytime systolic ARV, nighttime diastolic ARV', 'SD (standard deviation) and CV (coefficient of variance) of systolic and diastolic BP', 'long-term BP variability', 'cardiovascular mortality', 'ambulatory BP monitoring, average real variability (ARV', 'BP variability and subclinical target organ damage (TOD', 'BP variability', 'blood pressure variability and subclinical target organ damage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]",[],"[{'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",100.0,0.043857,None of the parameters of long-term BP variability were significantly higher among patients with TOD compared with those without TOD.,"[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'El Mokadem', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt. mostafa.elmokadem9@gmail.com.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Boshra', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Abd El Hady', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Kasla', 'Affiliation': 'Cardiology Clinic, 57357 Children Cancer Hospital, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Gouda', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}]",Journal of human hypertension,['10.1038/s41371-019-0286-8']
742,30844507,"Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter, Factorial, Randomized, Controlled Pilot Trial.","Persistent postsurgical pain is defined as pain localized to the area of surgery of a duration of ≥2 months and is, unfortunately, a common complication after breast cancer surgery. Although there is insufficient evidence to support any preventative strategy, prior literature suggests the possible efficacy of intravenous lidocaine and perioperative pregabalin in preventing persistent pain after surgery. To determine feasibility of conducting a larger definitive trial, we conducted a multicenter 2 × 2 factorial, randomized, placebo-controlled pilot trial of 100 female patients undergoing breast cancer surgery. Patients were randomized to receive an intraoperative lidocaine infusion (1.5 mg/kg bolus followed by 2 mg/kg/h) or placebo and perioperative pregabalin (300 mg preoperatively, 75 mg twice daily for 9 days) or placebo. All feasibility criteria were surpassed; recruitment of 100 patients was accomplished within 42 weeks, with a follow-up rate of 100% and study drug compliance of ≥80%. At 3 months, 53% of patients reported persistent neuropathic pain. Although there was no interaction between lidocaine and pregabalin, lidocaine decreased the development of persistent neuropathic pain (43.1% vs 63.3%; relative risk = .68; 95% confidence interval = .47-1.0). Pregabalin did not reduce persistent pain (60% vs 46%; relative risk = 1.3; 95% confidence interval = .90-1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life. Our pilot trial successfully demonstrated feasibility and provided promising data for conducting further trials of intraoperative lidocaine infusions during breast cancer surgeries. Clinical trial number: NCT02240199 PERSPECTIVE: This article reports the findings of a pilot randomized, controlled trial evaluating the effects of perioperative pregabalin and intraoperative lidocaine infusions in patients undergoing breast cancer surgery. This trial demonstrated the feasibility of conducting a larger trial and provided promising data that these interventions may decrease the development of persistent pain.",2019,"Pregabalin did not reduce persistent pain (60% vs 46%; relative risk = 1.3; 95% confidence interval = .90-1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life.","['100 female patients undergoing breast cancer surgery', 'patients undergoing breast cancer surgery', 'breast cancer surgeries', 'After Breast Cancer Surgery']","['placebo', 'lidocaine', 'intraoperative lidocaine infusions', 'pregabalin, lidocaine', 'intraoperative lidocaine infusion', 'Perioperative Pregabalin and Intraoperative Lidocaine', 'placebo and perioperative pregabalin', 'perioperative pregabalin and intraoperative lidocaine infusions', 'Pregabalin']","['acute postoperative pain, opioid consumption, pain interference, or quality of life', 'Neuropathic Pain', 'persistent pain', 'persistent neuropathic pain']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}]",100.0,0.628591,"Pregabalin did not reduce persistent pain (60% vs 46%; relative risk = 1.3; 95% confidence interval = .90-1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life.","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Khan', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada. Electronic address: james.khan@medportal.ca.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hodgson', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Reid', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Paul', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicole J Look', 'Initials': 'NJL', 'LastName': 'Hong', 'Affiliation': 'Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Holloway', 'Affiliation': 'Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Busse', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada; Michael G. DeGroote Institute for Pain Research and Care; Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilron', 'Affiliation': ""Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'D Norman', 'Initials': 'DN', 'LastName': 'Buckley', 'Affiliation': 'Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada; Michael G. DeGroote Institute for Pain Research and Care.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada; School of Nursing, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Hance', 'Initials': 'H', 'LastName': 'Clarke', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada; Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada; Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Palo Alto, California, USA.'}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Avram', 'Affiliation': 'Department of Surgery, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Pohl', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.02.010']
743,31714309,Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.,"BACKGROUND


Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections.
METHODS


Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI).
FINDINGS


In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection.
INTERPRETATION


Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.",2020,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"['healthy patient group', 'Eligible donors', '293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm', 'Renal Donation (POWAR']","['hand-assisted laparoscopic donor nephrectomy (HALDN', 'Placebo', 'preoperative single-dose intravenous co-amoxiclav or saline', 'placebo']","['clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI', 'LRTIs', 'Superficial SSIs', 'total infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",293.0,0.709113,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"[{'ForeName': 'Zubir', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Uwechue', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chandak', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Dellen', 'Affiliation': 'Dept of Renal and Pancreas Transplantation, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Barwell', 'Affiliation': 'Renal Transplant Unit, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heap', 'Affiliation': ""Renal Transplant Unit, St. George's Hospital, London, UK.""}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Szabo', 'Affiliation': ""Department of Microbiology and Infection, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hemsley', 'Affiliation': 'Department of Nephrology & Transplant Surgery, University Hospital of Wales, Cardiff & Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Olsburgh', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Kessaris', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nizam', 'Initials': 'N', 'LastName': 'Mamode', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}]",Annals of surgery,['10.1097/SLA.0000000000003666']
744,31411768,Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.,"In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 μg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors. Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months. This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups. Baseline risk subgroups included BMD T-score at the lumbar spine, total hip, and femoral neck (≤ - 2.5 versus > - 2.5 and ≤ -3.0 versus > - 3.0), history of nonvertebral fracture (yes/no), prevalent vertebral fracture (yes/no), and age (<65 versus 65 to <75 versus ≥75 years). Forest plots display treatment effect. Treatment-by-subgroup interactions were tested using the Breslow-Day test, Cox proportional hazards model, and ANCOVA model. After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups. BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group. No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed. The sequence of abaloparatide for 18 months followed by alendronate for up to 24 months appears to be an effective treatment option for a wide range of postmenopausal women at risk for osteoporotic fractures. © 2019 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.",2019,"BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.","['postmenopausal women at risk for osteoporotic fractures', 'Patients Treated With Abaloparatide Followed by', 'postmenopausal women at risk of osteoporotic fracture']","['abaloparatide/alendronate', 'placebo', 'alendronate', 'Alendronate', 'abaloparatide 80 μg daily (subcutaneous injection', 'sequential, open-label monotherapy with alendronate', 'placebo/alendronate', 'abaloparatide and placebo']","['relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures', 'BMD gains at the lumbar spine, total hip, and femoral neck', 'Fracture and Bone Mineral Density Response', 'BMD T-score at the lumbar spine, total hip, and femoral neck', 'bone mineral density (BMD', 'history of nonvertebral fracture', 'fracture risk reductions and BMD gains']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1272017', 'cui_str': 'At risk of osteoporotic fracture'}]","[{'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.115049,"BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group.","[{'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Zapalowski', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Ming-Yi', 'Initials': 'MY', 'LastName': 'Hu', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Hattersley', 'Affiliation': 'Radius Health, Inc., Waltham, MA, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'School of Medicine, University of California at Davis, Sacramento, CA, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Singer', 'Affiliation': 'Medstar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Dore', 'Affiliation': 'David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3848']
745,30924702,"A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD.","Objective:  The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years.  Method:  In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting.  Results:  Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p  < .05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly ( p  < .05) versus placebo. The most frequent AEs (≥15%) were somnolence, headache, and decreased appetite.  Conclusion:  SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.",2020,"RESULTS


Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p < .05; effect size [ES] = 0.547, 0.596, and 0.623).","['Children With ADHD', 'children aged 6 to 12 years', '222 participants were randomized to']","['SPN-812 (extended-release viloxazine', 'placebo', 'SPN-812 (Extended-Release Viloxazine', 'Placebo', 'SPN-812', 'placebo or SPN-812']","['CGI-S score', 'tolerated', 'laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting', 'CGI-I score', 'ADHD-RS-IV total score', 'somnolence, headache, and decreased appetite', 'severity of ADHD symptoms', 'ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0042665', 'cui_str': 'Viloxazine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",222.0,0.105641,"RESULTS


Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p < .05; effect size [ES] = 0.547, 0.596, and 0.623).","[{'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Tesfaye', 'Initials': 'T', 'LastName': 'Liranso', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Saylor', 'Affiliation': 'NeuroScience, Inc., Herndon, VA, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Tulloch', 'Affiliation': 'Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Adewole', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwabe', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Azmi', 'Initials': 'A', 'LastName': 'Nasser', 'Affiliation': 'Supernus Pharmaceuticals, Inc., Rockville, MD, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of attention disorders,['10.1177/1087054719836159']
746,25672894,Long-term effects of inhaled budesonide on screening-detected lung nodules.,"BACKGROUND


A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT.
PATIENTS AND METHODS


We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed.
RESULTS


The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms.
CONCLUSIONS


Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications.
CLINICAL TRIAL NUMBER


NCT01540552.",2015,The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm,[],"['low-dose computed tomography (LDCT', 'budesonide and placebo', 'placebo', 'inhaled budesonide', 'LDCT', 'budesonide']","['size of non-solid nodules', 'size of solid nodules', 'number of new lesions nor the number of lung cancers', 'screening-detected lung nodules', 'mean diameter of partially solid lesions', 'mean maximum diameter of non-solid nodules']",[],"[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0034079', 'cui_str': 'Lung nodule'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}]",,0.188636,The mean maximum diameter of non-solid nodules reduced significantly (from 5.03 mm at baseline to 2.61 mm after 5 years) in the budesonide arm,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Veronesi', 'Affiliation': 'Divisions of Thoracic Surgery. Electronic address: giulia.veronesi@ieo.it.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lazzeroni', 'Affiliation': 'Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Brown', 'Affiliation': 'Department of Clinical Cancer Prevention, University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'DeCensi', 'Affiliation': 'Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy; Division of Medical Oncology, Ospedali Galliera, Genoa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guerrieri-Gonzaga', 'Affiliation': 'Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellomi', 'Affiliation': 'Division of Radiology, European Institute of Oncology, Milan; University of Milan, Milan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Radice', 'Affiliation': 'Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Grimaldi', 'Affiliation': 'Division of Radiology, European Institute of Oncology, Milan.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spaggiari', 'Affiliation': 'Divisions of Thoracic Surgery; University of Milan, Milan.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bonanni', 'Affiliation': 'Cancer Prevention and Genetics, European Institute of Oncology, Milan, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv064']
747,30908879,Antegrade Hepatic Artery and Portal Vein Perfusion Versus Portal Vein Perfusion Alone in Living Donor Liver Transplantation: A Randomized Trial.,"Traditionally, deceased donor liver grafts receive dual perfusion (DP) through the portal vein and the hepatic artery (HA) either in situ or on the back table. HA perfusion is avoided in living donor liver grafts for fear of damage to the intima and consequent risk of hepatic artery thrombosis (HAT). However, biliary vasculature is predominantly derived from the HA. We hypothesized that antegrade perfusion of the HA in addition to the portal vein on the back table could reduce the incidence of postoperative biliary complications. Consecutive adult patients undergoing living donor liver transplantations were randomized after donor hepatectomy to receive graft perfusion of histidine-tryptophan-ketoglutarate solution either via both the HA and portal vein (DP group, n = 62) or only through the portal vein (standard perfusion [SP] group, n = 62). The primary endpoint was the occurrence of biliary complications (biliary leak/stricture). Secondary endpoints included HAT and patient survival. The incidence of biliary stricture was significantly lower in the DP group (6.5% versus 19.4%; odds ratio, 0.29; 95% confidence interval, 0.09-0.95; P = 0.04). There was no significant reduction in the incidence of HAT, bile leak, or hospital stay between the 2 groups. The 3-year mortality and graft survival rates were significantly higher among patients who received DP compared with SP (P = 0.004 and P = 0.003, respectively). On multivariate analysis, nonperfusion of the HA and preceding bile leak were found to be risk factors for the development of biliary stricture (P = 0.04 and P < 0.001, respectively). In conclusion, DP of living donor liver grafts through both the HA and portal vein on the back table may protect against the development of biliary stricture. This could translate to improved patient survival in the short term.",2019,"Three year patient and graft survival was significantly higher among patients who received dual perfusion compared to standard perfusion[P=0.004, P=0.003].","['live donor liver transplantation', 'Consecutive adult patients undergoing live donor liver transplants (LDLT']","['donor hepatectomy to receive graft perfusion of HTK (Histidine-tryptophan-ketoglutarate) solution either via both the hepatic artery and portal vein (dual perfusion group,n=62) or only through the portal vein (standard perfusion', 'Antegrade hepatic artery and portal vein perfusion versus portal vein perfusion alone']","['occurrence of biliary complications (biliary leak/stricture', 'graft survival', 'incidence of HAT, bile leak or hospital stay', 'patient survival', 'hepatic artery thrombosis and patient survival', 'biliary vasculature', 'incidence of biliary stricture']","[{'cui': 'C0348050', 'cui_str': 'Living Donors'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3544287', 'cui_str': 'Living donor liver transplant'}]","[{'cui': 'C0411259', 'cui_str': 'Removal of liver from donor (procedure)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0019602', 'cui_str': 'L-histidine'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0019145', 'cui_str': 'Hepatic artery (body structure)'}, {'cui': 'C0032718', 'cui_str': 'Portal Vein'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0444765', 'cui_str': 'Hat (physical object)'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392106', 'cui_str': 'Hepatic artery thrombosis (disorder)'}, {'cui': 'C0005839', 'cui_str': 'vasculature'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture (disorder)'}]",,0.0720787,"Three year patient and graft survival was significantly higher among patients who received dual perfusion compared to standard perfusion[P=0.004, P=0.003].","[{'ForeName': 'Johns', 'Initials': 'J', 'LastName': 'Shaji Mathew', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'K Y Santosh', 'Initials': 'KYS', 'LastName': 'Kumar', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Krishnanunni', 'Initials': 'K', 'LastName': 'Nair', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Binoj Sivasankara Pillai', 'Initials': 'BSP', 'LastName': 'Thankamony Amma', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Krishnakumar', 'Affiliation': 'Department of Transplant Anaesthesia, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Unnikrishnan', 'Initials': 'U', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Ramachandran Narayana', 'Initials': 'RN', 'LastName': 'Menon', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Sunny', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Dhar', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Othiyil Vayoth', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}, {'ForeName': 'Sudhindran', 'Initials': 'S', 'LastName': 'Surendran', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplant, Amrita Institute of Medical Sciences and Research Centre, Amrita University, Kochi, Kerala, India.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25455']
748,30887050,Reduction in acute kidney injury stage predicts survival in patients with type-1 hepatorenal syndrome.,"BACKGROUND


Hepatorenal syndrome type 1 (HRS-1), a form of acute kidney injury (AKI) in cirrhosis, has a median survival of days to weeks if untreated. The impact of reduction in AKI stage on overall survival in cirrhosis, independent of HRS reversal, is unclear.
METHODS


The Randomized, placEbo-controlled, double-blind study to confirm the reVERSal of HRS-1 with terlipressin study assessed terlipressin versus placebo, both with albumin, as treatment for HRS-1 for ≤14 days. Renal dysfunction severity was categorized by AKI stage at enrollment. Baseline patient characteristics were evaluated as predictors of AKI improvement using a multivariate model; the association between AKI stage reduction and 90-day survival was assessed using linear regression.
RESULTS


A total of 184 patients (terlipressin: n = 91; placebo: n = 93) with similar numbers in AKI Stages 1-3 (terlipressin/placebo, Stage 1: n = 25/26; Stage 2: n = 35/33; Stage 3: n = 31/34) were included. Predictors of AKI improvement were absence of alcoholic hepatitis, baseline serum creatinine and male gender. Overall survival was not significantly different across AKI stages (range 53-65%). In patients with no AKI worsening, 90-day survival was consistently better when AKI improved independent of HRS reversal, regardless of the initial AKI stage, with patients with Stage 1 at initial diagnosis achieving the greatest clinical benefit. A significant association was observed between AKI reduction and overall 90-day survival (P = 0.0022).
CONCLUSIONS


A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1. The goal for HRS-1 treatment should be less stringent than absolute HRS reversal.",2020,"A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1.","['184 patients (terlipressin: n\xa0=\xa091', '35/33; Stage 3: n\xa0=\xa031/34) were included', '25/26; Stage 2: n\xa0', 'Hepatorenal syndrome type 1', 'HRS-1 for ≤14\u2009days', 'patients with HRS-1', 'patients with type-1 hepatorenal syndrome']","['terlipressin versus placebo, both with albumin', 'placEbo', 'placebo: n\xa0=\xa093) with similar numbers in AKI Stages 1-3 (terlipressin/placebo, Stage 1: n\xa0']","['AKI stage reduction and 90-day survival', 'Renal dysfunction severity', 'Overall survival', 'alcoholic hepatitis, baseline serum creatinine and male gender', '90-day survival', 'AKI reduction and overall 90-day survival', 'overall survival']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal Syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}]","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0019187', 'cui_str': 'Hepatitis, Alcoholic'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",184.0,0.62913,"A reduction in AKI stage, independent of HRS reversal, was sufficient to improve overall survival in patients with HRS-1.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Boyer', 'Affiliation': 'Department of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Gastroenterology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Pappas', 'Affiliation': 'Scientific Affairs, Orphan Therapeutics, Lebanon, NJ, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Escalante', 'Affiliation': 'Biometrics, Mallinckrodt Pharmaceuticals, Bedminister, NJ, USA.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Jamil', 'Affiliation': 'Scientific Affairs, Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz048']
749,30816744,Nudging the better angels of our nature: A field experiment on morality and well-being.,"A field experiment examines how moral behavior, moral thoughts, and self-benefiting behavior affect daily well-being. Using experience sampling technology, we randomly grouped participants over 10 days to either behave morally, have moral thoughts, or do something positive for themselves. Participants received treatment-specific instructions in the morning of 5 days and no instructions on the other 5 control days. At each day's end, participants completed measures that examined, among others, subjective well-being, self-perceived morality and empathy, and social isolation and closeness. Full analyses found limited evidence for treatment- versus control-day differences. However, restricting analyses to occasions on which participants complied with instructions revealed treatment- versus control-day main effects on all measures, while showing that self-perceived morality and empathy toward others particularly increased in the moral deeds and moral thoughts group. These findings suggest that moral behavior, moral thoughts, and self-benefiting behavior are all effective means of boosting well-being, but only moral deeds and, perhaps surprisingly, also moral thoughts strengthen the moral self-concept and empathy. Results from an additional study assessing laypeople's predictions suggest that people do not fully intuit this pattern of results. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Full analyses found limited evidence for treatment- versus control-day differences.,[],[],"['subjective well-being, self-perceived morality and empathy, and social isolation and closeness']",[],[],"[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]",,0.0222172,Full analyses found limited evidence for treatment- versus control-day differences.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Waytz', 'Affiliation': 'Kellogg School of Management.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000588']
750,30908129,The relationship between binge drinking and prosocial bystander behavior among college men.,"Objectives:  This study prospectively examined binge drinking's effect on prosocial bystander behavior and indicators of bystander behavior: intentions to intervene, self-efficacy to intervene, and positive outcome expectancies for intervening.  Participants:  College men were recruited from February to April 2010.  Methods:  Pre- and posttest surveys were administered as part of a randomized controlled trial ( n  = 743). Potential confounders were identified using Pearson product-moment correlations. Controlling for covariates, multiple linear regression was used to examine whether binge drinking was predictive of prosocial bystander behavior and indicators of bystander behavior.  Results:  Binge drinking was related to lower bystander behavior ( p <.05), lower intentions to intervene ( p <.001), and less positive outcome expectancies for intervening ( p <.05).  Conclusions:  Binge drinking may reduce the ability to notice a risk situation and intervene as a prosocial bystander. Results highlight the need for bystander programs to address alcohol use within the context of bystander behavior.",2020,"RESULTS


Binge drinking was related to lower bystander behavior (p<.05), lower intentions to intervene (p<.001), and less positive outcome expectancies for intervening (p<.05).
","['college men', 'College men were recruited from February to April 2010']",[],['positive outcome expectancies'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.0285082,"RESULTS


Binge drinking was related to lower bystander behavior (p<.05), lower intentions to intervene (p<.001), and less positive outcome expectancies for intervening (p<.05).
","[{'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Schipani-McLaughlin', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'Salazar', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Alana M', 'Initials': 'AM', 'LastName': 'Vivolo-Kantor', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2019.1583656']
751,30470611,Association between precystectomy epithelial tumor marker response to neoadjuvant chemotherapy and oncological outcomes in urothelial bladder cancer.,"INTRODUCTION AND OBJECTIVES


We previously reported that elevated precystectomy serum levels of epithelial tumor markers predict worse oncological outcome in patients with invasive bladder cancer (BC). Herein, we evaluated the effect of neoadjuvant chemotherapy (NAC) on elevated tumor marker levels and their association with oncological outcomes.
METHODS


Under IRB approval, serum levels of Carbohydrate Antigen 125 (CA-125), Carbohydrate Antigen 19-9 (CA 19-9) and Carcinoembryonic Antigen (CEA) were prospectively measured in 480 patients with invasive BC from August 2011 through December 2016. In the subgroup undergoing NAC, markers were measured prior to the first and after the last cycle of chemotherapy (prior to cystectomy).
RESULTS


Three hundred and thirty-seven patients were eligible for the study, with a median age was 71 years (range 34-93) and 81% (272) male. Elevated precystectomy level of any tumor markers (31% of patients) was independently associated with worse recurrence-free survival (hazard ratio [HR] = 2.81; P < 0.001) and overall survival (HR = 3.97; P < 0.001). One hundred and twenty-five (37%) patients underwent NAC, of whom 59 had a complete tumor marker profile and 30 (51%) had an elevated pre-NAC tumor marker. Following completion of chemotherapy, 10/30 (33%) patients normalized their tumor markers, while 20/30 (67%) had one or more persistently elevated markers. There was no difference in clinical or pathological stage between groups (P = 0.54 and P = 0.09, respectively). Further analysis showed a significantly lower rate and longer median time to recurrence/progression in the responder group (50% in responders vs. 90% in nonresponders at a median time of 22 vs. 4.8 months, respectively; P = 0.015). There was also significant difference in mortality rates and median overall survival between the study groups (30% in responders vs. 70% in nonresponders at a median time of 27.3 vs. 11.6 months respectively; P = 0.037). Two of the three patients that died in the normalized tumor marker group had tumor marker relapse at recurrence prior to their death.
CONCLUSIONS


To our knowledge, this is the first study showing tumor marker response to NAC. Patients with persistently elevated markers following NAC have a very poor prognosis following cystectomy, which may help identifying chemotherapy-resistant tumors. A larger, controlled study with longer follow up is needed to determine their role in predicting survival.",2019,"There was no difference in clinical or pathological stage between groups (P = 0.54 and P = 0.09, respectively).","['patients with invasive bladder cancer (BC', 'Three hundred and thirty-seven patients were eligible for the study, with a median age was 71 years (range 34-93) and 81% (272) male', 'urothelial bladder cancer', '480 patients with invasive BC from August 2011 through December 2016']","['neoadjuvant chemotherapy', 'neoadjuvant chemotherapy (NAC']","['Carcinoembryonic Antigen (CEA', 'rate and longer median time to recurrence/progression', 'clinical or pathological stage', 'mortality rates and median overall survival', 'recurrence-free survival', 'Elevated precystectomy level of any tumor markers', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0007082', 'cui_str': 'Antigens, CD66e'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}]",480.0,0.153004,"There was no difference in clinical or pathological stage between groups (P = 0.54 and P = 0.09, respectively).","[{'ForeName': 'Soroush T', 'Initials': 'ST', 'LastName': 'Bazargani', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Clifford', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Djaladat', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Schuckman', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wayne', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Miranda', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA.'}, {'ForeName': 'Sarmad', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Clinical Medicine, Section of Genitourinary (Gu) Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Dorff', 'Affiliation': 'Department of Clinical Medicine, Section of Genitourinary (Gu) Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Department of Clinical Medicine, Section of Genitourinary (Gu) Oncology, USC Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Daneshmand', 'Affiliation': 'Norris Comprehensive Cancer Center, USC Institute of Urology, Los Angeles, CA. Electronic address: siadaneshmand@yahoo.com.'}]",Urologic oncology,['10.1016/j.urolonc.2018.09.008']
752,30815933,"A pilot evaluation of an advocacy programme on knowledge, empowerment, family-school partnership and parent well-being.","BACKGROUND


Internationally, it has been recognised that parents need to advocate for their children with disabilities to receive services. However, many parents find advocacy difficult because of systemic and logistical barriers. As such, parents of children with disabilities may seek a special education advocate to help them understand their child's rights and secure services. Yet little research has been conducted about programmes to develop special education advocates.
METHODS


In this study, we conducted a comparison study to determine the association of an advocacy programme (i.e. the Volunteer Advocacy Project) on a primary outcome (i.e. special education knowledge) and other outcomes (i.e. family-school partnership, empowerment and parent well-being). Specifically, in 2017, 34 participants, all mothers of children with disabilities, were recruited from disability organisations in the USA. Seventeen mothers participated in the intervention group (i.e. the advocacy training), while 17 mothers participated in the wait list control group. The Volunteer Advocacy Project is a 36 hr advocacy training for individuals to gain instrumental and affective knowledge to advocate for their own children with disabilities and for other families. All participants completed a pre-survey and post-survey; only intervention group participants completed a 6-month follow-up survey.
RESULTS


Compared with 17 wait list control group participants, the 17 intervention group participants demonstrated improvements in special education knowledge, P = 0.002, η 2   = 0.32, and self-mastery, P = 0.04, η 2   = 0.15, and decreases in the quality of family-school partnerships, P = 0.002, η 2   = 0.32. At the follow-up survey, intervention group participants demonstrated increases in empowerment, P = 0.04, η 2   = 0.29, and special education knowledge, P = 0.02, η 2   = 0.38.
CONCLUSIONS


Implications for research including the need for a randomised controlled trial are discussed; also, practitioners need to evaluate advocacy training programmes regarding their effectiveness.",2019,"At the follow-up survey, intervention group participants demonstrated increases in empowerment, P = 0.04, η 2   = 0.29, and special education knowledge, P = 0.02, η 2   = 0.38.
","['Seventeen mothers participated in the intervention group (i.e. the advocacy training), while 17 mothers participated in the wait list control group', 'parents of children with disabilities', '34 participants, all mothers of children with disabilities, were recruited from disability organisations in the USA']","['advocacy programme (i.e. the Volunteer Advocacy Project', 'advocacy training', 'advocacy programme']","['quality of family-school partnerships', 'special education knowledge']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0259916', 'cui_str': 'Children with Disabilities'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}]","[{'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013649', 'cui_str': 'Special Education'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",17.0,0.0401774,"At the follow-up survey, intervention group participants demonstrated increases in empowerment, P = 0.04, η 2   = 0.29, and special education knowledge, P = 0.02, η 2   = 0.38.
","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Burke', 'Affiliation': 'Department of Special Education, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Lee', 'Affiliation': 'Department of Special Education, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rios', 'Affiliation': 'Department of Special Education, University of Illinois at Urbana-Champaign, Champaign, IL, USA.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12613']
753,30798790,Stepped approach to improving sexual function after gynaecological cancer: the SAFFRON feasibility RCT.,"BACKGROUND


Women affected by gynaecological cancer are often unaware of the sexual consequences of both the cancer and its treatment. Most do not receive appropriate advice or help to recover sexual function, and the effect on their sexuality may be profound, both physically and emotionally. However, several potential therapies can be effective in helping recover some sexual engagement and change self-perception around sex. A major initial challenge is informing and involving patients in an appropriate and sensitive manner, and a further issue is delivering therapies in busy gynaelogical oncology clinics. This study was conceived in response to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA) call asking for proposals to improve sexual functioning in women treated for gynaecological cancer while taking into account associated issues of mood. Existing evidence-based therapies for improving sexual function after cancer treatment were adapted and placed within a 'stepped care' model for delivering these in the NHS setting. An assessment and treatment stepping algorithm was developed in parallel, both to assign women to a treatment level at assessment and to follow their progress session by session to advise on changing intervention level. The assessment tool was applied to all participants on the principle that the problem was sexual difficulty, not the cancer of origin.
PARTICIPANTS


Women aged > 18 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions.
DESIGN


A feasibility two-arm, parallel-group randomised controlled pilot trial.
SETTING


Two NHS gynaecological cancer centres, one in London and one in Bristol.
INTERVENTIONS


A three-level stepped care intervention.
OBJECTIVE


To assess the feasibility of conducting a full-scale investigation of stepped therapy and indicate the potential benefits to patients and to the NHS generally.
PRIMARY OUTCOME MEASURES


Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial.
RESULTS


Development of the intervention and accompanying algorithm was completed. The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
LIMITATIONS


As the study did not proceed, the intervention and its accompanying algorithm have not been evaluated in practice, and the capacity of the NHS system to deliver it has not been examined.
CONCLUSIONS


None, as the study was halted.
FUTURE WORK


The intervention could be studied within a clinical setting; however, the experience of the study group points to the need for psychosocial studies in medical settings to establish pragmatic and innovative mechanisms to ensure adequate resource when extending staff clinical skills and time to deliver any new intervention for the duration of the trial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN12010952 and ClinicalTrials.gov NCT02458001.
FUNDING


This project was funded by the NIHR HTA programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 5. See the NIHR Journals Library website for further project information.",2019,"The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
","['Women aged >\u200918 years (with partners at their choice) treated for any gynaecological malignancy with surgery and/or chemotherapy and/or radiation at University College London Hospital or Bristol Gynaecological cancer centres, minimally 3 months post end of treatment, of any sexual orientation, with sexual function difficulties identified by three initial screening questions', 'National Institute for Health Research (NIHR', 'after gynaecological cancer', 'Two NHS gynaecological cancer centres, one in London and one in Bristol']",['Health Technology Assessment (HTA) call asking for proposals'],"['sexual functioning', 'Recruitment to study, proportion of women stepping up, number of usable data points of all measures and time points over length of trial, and retention of participants to end of trial', 'sexual function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205949', 'cui_str': 'Sexual Orientation'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}]","[{'cui': 'C0039423', 'cui_str': 'Technology Assessment, Health'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",,0.0482877,"The study was stopped before the recruitment stage and, hence, no randomisation, recruitment, numbers analysed, outcomes or harms were recorded.
","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Gessler', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lemma', 'Affiliation': 'Psychological Therapies Development Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dunning', 'Affiliation': 'Patient Advocate, London, UK.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Madden', 'Affiliation': 'Patient Advocate, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Research Department of Clinical Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'PRIMENT Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Summerville', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'MacDonald', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Olaitan', 'Affiliation': 'Gynaecological Cancer Centre, University College London Hospitals, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Lanceley', 'Affiliation': ""Department of Women's Cancer, Institute for Women's Health, University College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23060']
754,31887222,Treatment effect of oil-based contrast is related to experienced pain at HSG: a post-hoc analysis of the randomised H2Oil study.,"STUDY QUESTION


Does pain or volume of used contrast medium impact the effectiveness of oil-based contrast during hysterosalpingography (HSG)?
SUMMARY ANSWER


In women who report moderate to severe pain during HSG, the use of oil-based contrast resulted in more ongoing pregnancies compared to the use of water-based contrast, whereas in women who reported mild or no pain, no difference in ongoing pregnancies was found.
WHAT IS KNOWN ALREADY


We recently showed that in infertile women undergoing HSG, the use of oil-based contrast results in more ongoing pregnancies within 6 months as compared to the use of water-based contrast. However, the underlying mechanism of this fertility-enhancing effect remains unclear.
STUDY DESIGN, SIZE, DURATION


We performed a post-hoc analysis of the H2Oil study, a multicentre randomised controlled trial (RCT) evaluating the therapeutic effect of oil- and water-based contrast at HSG. Here, we evaluated the impact of pain experienced at HSG and volume of used contrast media during HSG on ongoing pregnancy.
PARTICIPANTS/MATERIALS, SETTING, METHODS


In a subset of 400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0-10.0 cm) was reported, while in 512 women, we registered the volume of used contrast (in millilitres). We used logistic regression analyses to assess whether pain and volume of used contrast media modified the effect of oil-based contrast on ongoing pregnancy rates. Data were analysed according to intention-to-treat principle.
MAIN RESULTS AND THE ROLE OF CHANCE


In 400 women in whom pain scores were reported, the overall median pain score was 5.0 (Interquartile range (IQR) 3.0-6.8) (oil group (n = 199) 4.8 (IQR 3.0-6.4); water group (n = 201) 5.0 (IQR 3.0-6.7); P-value 0.28). There was a significant interaction between pain (VAS ≤5 versus VAS ≥6) and the primary outcome ongoing pregnancy (P-value 0.047). In women experiencing pain (VAS ≥6), HSG with oil-based contrast resulted in better 6-month ongoing pregnancy rates compared to HSG with water-based contrast (49.4% versus 29.6%; RR 1.7; 95% CI, 1.1-2.5), while in women with a pain score ≤5, 6-month ongoing pregnancy rates were not significantly different between the use of oil- (28.8%) versus water-based contrast (29.2%) (RR 0.99; 95% CI, 0.66-1.5). In the 512 women in whom we recorded contrast, median volume was 9.0 ml (IQR 5.7-15.0) in the oil group versus 8.0 ml (IQR 5.9-13.0) in the water group, respectively (P-value 0.72). Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23).
LIMITATIONS, REASONS FOR CAUTION


This was a post-hoc analysis that should be considered as hypothesis generating. The RCT was restricted to infertile ovulatory women, younger than 39 years of age and with a low risk for tubal pathology. Therefore, our results should not be generalised to infertile women who do not share these features.
WIDER IMPLICATIONS OF THE FINDINGS


The underlying mechanism of the fertility-enhancing effect induced by HSG with the use of oil-based contrast remains unclear. However, these findings suggest a possible mechanistic pathway, that is increasing intrauterine pressure occurring prior to dislodging pregnancy hindering debris or mucus plugs from the proximal part of otherwise normal fallopian tubes. This information might help in the search of the underlying fertility-enhancing mechanism found by using oil-based contrast during HSG.
STUDY FUNDING/COMPETING INTEREST(S)


The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports consultancy for Guerbet. H.V. reports consultancy fees from Ferring. C.B.L. reports speakers' fees from Ferring and research grants from Ferring, Merck and Guerbet. V.M. reports receiving travel and speakers fees as well as research grants from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflict of interests.
TRIAL REGISTRATION NUMBER


The H2Oil study was registered at the Netherlands Trial Registry (NTR 3270).
TRIAL REGISTRATION DATE


1 February 2012.
DATE OF FIRST PATIENT’S ENROLMENT


3 February 2012.",2019,"Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23).
","['infertile women who do not share these features', 'infertile women undergoing', 'infertile ovulatory women, younger than 39\xa0years of age and with a low risk for tubal pathology', '400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0-10.0 cm) was reported, while in 512 women']","['oil-based contrast', 'oil- and water-based contrast at HSG', 'oil-based contrast during hysterosalpingography (HSG', 'HSG']","['median volume', 'pain scores', 'pain score', 'overall median pain score', '6-month ongoing pregnancy rates', 'severe pain']","[{'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",512.0,0.128665,"Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23).
","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Verhoeve', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam 1091 AC, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam 1105 AZ, The Netherlands.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Nap', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem 6815 AD, The Netherlands.'}, {'ForeName': 'J M J', 'Initials': 'JMJ', 'LastName': 'Smeenk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elisabeth-TweeSteden Hospital, Tilburg 5022 GC, The Netherlands.'}, {'ForeName': 'M A F', 'Initials': 'MAF', 'LastName': 'Traas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn 7334 DZ, The Netherlands.'}, {'ForeName': 'H G M', 'Initials': 'HGM', 'LastName': 'Rijnsaardt-Lukassen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital, Dordrecht 3318 AT, The Netherlands.'}, {'ForeName': 'A J C M', 'Initials': 'AJCM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hospital Gelderse Vallei, Ede 6716 RP, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bourdrez', 'Affiliation': 'Department of Obstetrics and Gynaecology, VieCuri Medical Centre, Venlo 5912 BL, The Netherlands.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'de Bruin', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's Hertogenbosch 5223 GZ, The Netherlands.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sluijmer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Wilhelmina Hospital, Assen 9401 RK, The Netherlands.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Hospital, Helmond 5707 HA, The Netherlands.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam 1081 HV, The Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, VIC 3800, Australia.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez206']
755,30892806,"Rationale and design of the DIGIT-HF trial (DIGitoxin to Improve ouTcomes in patients with advanced chronic Heart Failure): a randomized, double-blind, placebo-controlled study.","AIMS


Despite recent advances in the treatment of chronic heart failure (HF), mortality and hospitalizations still remain high. Additional therapies to improve mortality and morbidity are urgently needed. The efficacy of cardiac glycosides - although regularly used for HF treatment - remains unclear. DIGIT-HF was designed to demonstrate that digitoxin on top of standard of care treatment improves mortality and morbidity in patients with HF and a reduced ejection fraction (HFrEF).
METHODS


Patients with chronic HF, New York Heart Association (NYHA) functional class III-IV and left ventricular ejection fraction (LVEF) ≤ 40%, or patients in NYHA functional class II and LVEF ≤ 30% are randomized 1:1 in a double-blind fashion to treatment with digitoxin (target serum concentration 8-18 ng/mL) or matching placebo. Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline. A total of 2190 eligible patients will be included in this clinical trial (1095 per group). All patients receive standard of care treatment recommended by expert guidelines upon discretion of the treating physician. The primary outcome is a composite of all-cause mortality or hospital admission for worsening HF (whatever occurs first). Key secondary endpoints are all-cause mortality, hospital admission for worsening HF, and recurrent hospital admission for worsening HF.
CONCLUSION


The DIGIT-HF trial will provide important evidence, whether the cardiac glycoside digitoxin reduces the risk for all-cause mortality and/or hospital admission for worsening HF in patients with advanced chronic HFrEF on top of standard of care treatment.",2019,"Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline.","['Patients with chronic HF, New York Heart Association (NYHA) functional class III-IV and left ventricular ejection fraction (LVEF', '≤\u200940%, or patients in NYHA functional class II and LVEF ≤\u200930', 'patients with advanced chronic HFrEF on top of standard of care treatment', '2190 eligible patients will be included in this clinical trial (1095 per group', 'patients with advanced chronic Heart Failure', 'patients with HF and a reduced ejection fraction (HFrEF']","['standard of care treatment recommended by expert guidelines upon discretion of the treating physician', 'digitoxin', 'digitoxin (target serum concentration 8-18\u2009ng/mL) or matching placebo', 'placebo']","['cause mortality, hospital admission for worsening HF, and recurrent hospital admission for worsening HF.\nCONCLUSION', 'mortality and morbidity', 'composite of all-cause mortality or hospital admission for worsening HF (whatever occurs first']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0012258', 'cui_str': 'Digitoxin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",2190.0,0.367173,"Randomization is stratified by centre, sex, NYHA functional class (II, III, or IV), atrial fibrillation, and treatment with cardiac glycosides at baseline.","[{'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bavendiek', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Berliner', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Lukas Aguirre', 'Initials': 'LA', 'LastName': 'Dávila', 'Affiliation': 'Department of Biostatistics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schwab', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Clinical Center Nuernberg, Paracelsus Medical University, Nuernberg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Maier', 'Affiliation': 'Department of Internal Medicine II, University Medical Center Regensburg, Regensburg, Germany.'}, {'ForeName': 'Sebastian A', 'Initials': 'SA', 'LastName': 'Philipp', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, Elbe Clinic Stade, Stade, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Rieth', 'Affiliation': 'Department of Cardiology, Kerckhoff Heart, Rheuma and Thoracic Center, Bad Nauheim, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Westenfeld', 'Affiliation': 'Department of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Piorkowski', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Technology Dresden, Dresden, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Weber', 'Affiliation': 'Department of Biostatistics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Hänselmann', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Maximiliane', 'Initials': 'M', 'LastName': 'Oldhafer', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schallhorn', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'von der Leyen', 'Affiliation': 'Hannover Clinical Trial Centre, Hannover, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schröder', 'Affiliation': 'Institute of Clinical Pharmacology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Veltmann', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Störk', 'Affiliation': 'Department of Internal Medicine I, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Department of Internal Medicine III, University Hospital of the Saarland, Homburg, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Department of Biostatistics, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Bauersachs', 'Affiliation': 'Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1452']
756,30847805,Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee.,"Triamcinolone acetonide extended-release (ER) 32 mg (Zilretta ® ) is approved in the USA for the management of osteoarthritis (OA) pain of the knee and is administered as a single, 5 mL intra-articular (IA) injection. Although the therapeutic effects from IA corticosteroids are typically short-lived, triamcinolone acetonide ER is formulated in poly (lactic-co-glycolic acid) (PLGA) microspheres that slowly release triamcinolone acetonide in the synovium, enabling their prolonged presence in the joint. This reduces systemic exposure and lessens corticosteroid-related systemic adverse reactions, such as blood glucose elevations. In a 24-week, randomized, phase III clinical trial, triamcinolone acetonide ER 32 mg significantly improved mean average daily pain intensity in patients with knee OA relative to placebo, and pain, stiffness and physical function (according to WOMAC criteria) relative to placebo and triamcinolone acetonide crystalline suspension (CS). Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo. Findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee.",2019,"Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo.",['patients with knee OA relative to'],"['triamcinolone acetonide', 'placebo', 'Triamcinolone Acetonide Extended-Release', '32\xa0mg (Zilretta ® ', 'Triamcinolone acetonide', 'placebo and triamcinolone acetonide crystalline suspension (CS', 'Triamcinolone acetonide ER', 'triamcinolone acetonide ER']","['release (ER', 'blood glucose elevations', 'mean average daily pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4529671', 'cui_str': 'Zilretta'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.060841,"Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Paik', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': 'Duggan', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Keam', 'Affiliation': 'Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.'}]",Drugs,['10.1007/s40265-019-01083-3']
757,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
758,30817246,Effect of Trendelenburg position and lower-body positive pressure on neck fluid distribution.,"Fluid that shifts out of the legs and into the neck when supine can contribute to upper-airway narrowing. The present study investigates the relative contributions of vascular and extravascular fluid to the total accumulation of neck fluid volume (NFV). In 22 healthy awake participants (8 women), aged 42 ± 9 yr, we measured NFV with bioelectrical impedance, internal jugular vein volume (IJVV) with ultrasound, and extravascular NFV (NFV EV ) as the difference between NFV and IJVV. Participants were randomly allocated to control and intervention, both of which were conducted on the same day. Measurements were made at baseline and every 5 min thereafter during control and intervention. During intervention, participants received 40 mmHg lower-body positive pressure (LBPP) when supine, followed by LBPP plus 10° Trendelenburg position, then LBPP when supine again, followed by recovery. During control, participants lay supine for equal time. LBPP and LBPP plus Trendelenburg position both increased NFV from baseline compared with control ( P  < 0.001), with significant contributions from IJVV ( P  < 0.001). Returning to supine with LBPP, IJVV returned to baseline, but NFV remained elevated because of accumulation of NFV EV.  These findings suggest that contributions of IJVV to NFV are immediate but transient, whereas sustained elevation in NFV when supine is likely a result of NFV EV . These findings add new insights into the mechanism by which fluid accumulates in the neck by rostral fluid shift.  NEW & NOTEWORTHY  This study demonstrates that lying supine for 30 min as well as increased fluid shift out of the legs to simulate nocturnal rostral fluid shift causes fluid to accumulate mainly in the extravascular space of the neck rather than in the internal jugular veins. Therefore, in subjects without fluid-retaining states, extravascular neck fluid accumulation overnight might play a more significant role in the pathophysiology of upper-airway narrowing than intravascular fluid accumulation.",2019,"LBPP and LBPP plus Trendelenburg position both increased NFV from baseline compared with control ( P  < 0.001), with significant contributions from IJVV ( P  < 0.001).","['22 healthy awake participants (8 women), aged 42\u2009±\u20099 yr']","['Trendelenburg position and lower-body positive pressure', '40 mmHg lower-body positive pressure (LBPP']","['LBPP and LBPP plus Trendelenburg position both increased NFV', 'NFV with bioelectrical impedance, internal jugular vein volume (IJVV) with ultrasound, and extravascular NFV (NFV EV ']","[{'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0277812', 'cui_str': 'Trendelenburg Position'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0277812', 'cui_str': 'Trendelenburg Position'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]",22.0,0.0416471,"LBPP and LBPP plus Trendelenburg position both increased NFV from baseline compared with control ( P  < 0.001), with significant contributions from IJVV ( P  < 0.001).","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Yadollahi', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}, {'ForeName': 'Bhajan', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Millar', 'Affiliation': 'Human Health and Nutritional Sciences, University of Guelph , Guelph, Ontario , Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vena', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'Department of Medicine, University of Toronto , Toronto, Ontario , Canada.'}, {'ForeName': 'T Douglas', 'Initials': 'TD', 'LastName': 'Bradley', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network , Toronto, Ontario , Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00926.2018']
759,30849021,The impact of a health education intervention on health behaviors and mental health among Chinese college students.,"Objective:  This study aimed to assess the impact of a health education intervention on health behaviors, self-efficacy, and well-being among college students.  Participants:  Between March and October 2016, a total of 532 undergraduates participated.  Methods:  A theory-based intervention was conducted at Wuhan University, China. Participants were assigned to a control or intervention group (IG). The IG attended a 7-week health education class on knowledge, attitude, and practice of health behaviors.  Results:  Participants in the IG, compared with those in the control group (CG), reported significantly increased prevalence of high physical activity and regular breakfast, as well as lower screen time, sugar beverage intake, and Internet addiction tendency. Furthermore, intervention students improved in health behavior scores ( p  = 0.040), compared with the CG, while the changes in subjective well-being and self-efficacy remained similar between the two groups.  Conclusions:  Health education may promote health behaviors among Chinese college students.",2020,"Furthermore, intervention students improved in health behavior scores (p = 0.040), compared with the CG, while the changes in subjective well-being and self-efficacy remained similar between the two groups.
","['Chinese college students', 'college students', 'Between March and October 2016, a total of 532 undergraduates participated.\nMETHODS']",['health education intervention'],"['health behaviors', 'health behaviors, self-efficacy', 'health behaviors and mental health', 'prevalence of high physical activity and regular breakfast, as well as lower screen time, sugar beverage intake, and Internet addiction tendency', 'subjective well-being and self-efficacy', 'health behavior scores']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",[{'cui': 'C0018701'}],"[{'cui': 'C0018687'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",532.0,0.0248817,"Furthermore, intervention students improved in health behavior scores (p = 0.040), compared with the CG, while the changes in subjective well-being and self-efficacy remained similar between the two groups.
","[{'ForeName': 'Xu-Hao', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Hong-Jie', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Liu', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Bo-Wen', 'Initials': 'BW', 'LastName': 'Tang', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Yuan', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Danijela', 'Initials': 'D', 'LastName': 'Gasevic', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Paul', 'Affiliation': 'Institute for Sport, Physical Education and Health Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Pei-Gang', 'Initials': 'PG', 'LastName': 'Wang', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}, {'ForeName': 'Qi-Qiang', 'Initials': 'QQ', 'LastName': 'He', 'Affiliation': ""School of Health Sciences, Wuhan University, Wuhan, People's Republic of China.""}]",Journal of American college health : J of ACH,['10.1080/07448481.2019.1583659']
760,31698917,Cardiac Magnetic Resonance Imaging used for Evaluation of Adipose-Derived Stromal Cell Therapy in Patients with Chronic Ischemic Heart Disease.,"Adipose-derived stromal cell (ASC) therapy is currently investigated as a new treatment option for patients with ischemic heart disease (IHD). The aim of this study was to evaluate the effect of ASC therapy in patients with chronic IHD measuring myocardial perfusion and cardiac function using cardiac magnetic resonance imaging (CMRI). Patients were included in MyStromalCell trial, a phase II, randomized, double-blinded, placebo-controlled study investigated the effect of ASCs in patients with chronic IHD with preserved left ventricular ejection fraction (LVEF). In total, 41 of 60 patients underwent cine, late enhancement, rest and stress imaging with CMRI. There was a non-significant difference between stress and rest values in maximal signal intensity, a measure of myocardial perfusion, from baseline to follow-up comparing placebo with ASC group (-52.52 ± 88.61 and 3.05 ± 63.17,  p  = 0.061, respectively). LVEF, myocardial mass, stroke volume, left ventricle end-diastolic volume and end-systolic volume changed non-significantly (-0.5 ± 4.7%, -3.5 ± 13.1 g, -0.7 ± 8.6 mL, 1.9 ± 25.1 mL and 2.6 ± 16.5 mL, respectively) in the placebo group and in the ASC group (0.7 ± 8.6%, 0.9 ± 10.8 g, -0.3 ± 26.1 mL, -3.0 ± 31.5 mL and -2.7 ± 20.4 mL, respectively) from baseline to 6 months follow-up. The amount of scar tissue was unchanged in the placebo group by 0.0 ± 1.6 g,  p  = 1.0 and in the ASC group with -0.3 ± 2.3 g,  p  = 0.540. There was no difference between the groups. There was a non-significant trend toward increased myocardial perfusion but no significant changes in functional parameters or amount of scar tissue in patients treated with ASCs compared with patients allocated into the placebo group.",2019,There was a non-significant trend toward increased myocardial perfusion but no significant changes in functional parameters or amount of scar tissue in patients treated with ASCs compared with patients allocated into the placebo group.,"['patients with ischemic heart disease (IHD', 'patients with chronic IHD with preserved left ventricular ejection fraction (LVEF', 'Patients with Chronic Ischemic Heart Disease', 'patients with chronic IHD measuring myocardial perfusion and cardiac function using']","['cardiac magnetic resonance imaging (CMRI', 'placebo', 'Adipose-derived stromal cell (ASC) therapy', 'Adipose-Derived Stromal Cell Therapy', 'Cardiac Magnetic Resonance Imaging', 'ASC therapy']","['LVEF, myocardial mass, stroke volume, left ventricle end-diastolic volume and end-systolic volume', 'amount of scar tissue', 'myocardial perfusion', 'stress and rest values in maximal signal intensity, a measure of myocardial perfusion', 'functional parameters or amount of scar tissue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0264694', 'cui_str': 'Chronic myocardial ischemia (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0225897', 'cui_str': 'Left Ventricle'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C2004491', 'cui_str': 'Scars'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",60.0,0.355122,There was a non-significant trend toward increased myocardial perfusion but no significant changes in functional parameters or amount of scar tissue in patients treated with ASCs compared with patients allocated into the placebo group.,"[{'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Qayyum', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders Bruun', 'Initials': 'AB', 'LastName': 'Mathiasen', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Naja Dam', 'Initials': 'ND', 'LastName': 'Mygind', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels Groove', 'Initials': 'NG', 'LastName': 'Vejlstrup', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Department of Cardiology & Cardiac Catheterization Laboratory 2014, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.'}]",Cell transplantation,['10.1177/0963689719883592']
761,31701699,"γ-Linolenic Acid versus α-Lipoic Acid for Treating Painful Diabetic Neuropathy in Adults: A 12-Week, Double-Placebo, Randomized, Noninferiority Trial.","BACKGROUND


This study was a multicenter, parallel-group, double-blind, double-dummy, randomized, noninferiority trial to evaluate the efficacy and safety of γ-linolenic acid (GLA) relative to α-lipoic acid (ALA) over a 12-week treatment period in type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN).
METHODS


This study included 100 T2DM patients between 20 and 75 years of age who had painful DPN and received either GLA (320 mg/day) and placebo or ALA (600 mg/day) and placebo for 12 weeks. The primary outcome measures were mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS).
RESULTS


Of the 100 subjects who initially participated in the study, 73 completed the 12-week treatment period. Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups. The treatment difference for the VAS (95% confidence interval [CI]) between the two groups was -0.65 (-1.526 to 0.213) and the upper bound of the 95% CI did not exceed the predefined noninferiority margin (δ₁=0.51). For the TSS, the treatment difference was -0.05 (-1.211 to 1.101) but the upper bound of the 95% CI crossed the noninferiority margin (δ₂=0.054). There were no serious adverse events associated with the treatments.
CONCLUSION


GLA treatment in patients with painful DPN was noninferior to ALA in terms of reducing pain intensity measured by the VAS over 12 weeks.",2020,"Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups.","['type 2 diabetes mellitus (T2DM) patients with painful diabetic peripheral neuropathy (DPN', 'Adults', '100 T2DM patients between 20 and 75 years of age who had painful DPN and received either', '100 subjects who initially participated in the study', 'patients with painful DPN']","['placebo or ALA', 'γ-Linolenic Acid versus α-Lipoic Acid', 'placebo', 'Double-Placebo', 'γ-linolenic acid (GLA) relative to α-lipoic acid (ALA', 'GLA']","['mean changes in pain intensities as measured by the visual analogue scale (VAS) and the total symptom scores (TSS', 'pain intensity', 'mean VAS and TSS scores', 'VAS', 'serious adverse events']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0740447', 'cui_str': 'Peripheral neuropathy co-occurrent and due to diabetes mellitus'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",73.0,0.297576,"Per-protocol analyses revealed significant decreases in the mean VAS and TSS scores compared to baseline in both groups, but there were no significant differences between the groups.","[{'ForeName': 'Jong Chul', 'Initials': 'JC', 'LastName': 'Won', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyuk Sang', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Seong Su', 'Initials': 'SS', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Dongguk University College of Medicine, Gyeongju, Korea.'}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Chong Hwa', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea.'}, {'ForeName': 'Ie Byung', 'Initials': 'IB', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicien, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'In Joo', 'Initials': 'IJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Bong Yun', 'Initials': 'BY', 'LastName': 'Cha', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Tae Sun', 'Initials': 'TS', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea. pts@jbnu.ac.kr.'}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0099']
762,30773722,"Vitamin D-supplemented yogurt drink reduces Candida infections in a paediatric intensive care unit: a randomised, placebo-controlled clinical trial.","BACKGROUND


The prevalence of Candida infections in paediatric intensive care units (PICUs) has dramatically increased as a result of resistance to conventional anti-fungal treatments. Because vitamin D has been shown to exhibit fungicidal activity against Candida infection in an in vitro antimicrobial screening, we aimed to investigate the effect of vitamin D on Candida infections in the PICU.
METHODS


Four hundred sixteen eligible children aged between 12 months to 5 years old admitted to the PICU, who were on broad-spectrum antibiotic therapy, participated in the study. Patients were randomly assigned to two study groups, receiving a plain yogurt drink (placebo group) or supplemented with 300 IU day -1  vitamin D (VD group). Primary outcome was defined as the incidences of Candida colonisation (Candida isolated from rectal swab) 14 days after enrollment. Secondary outcome measures were Candida growth in blood (candidaemia) and urine (candiduria).
RESULTS


The prevalence of candiduria as well as candidaemia was significantly lower in the VD-treated group (26 cases) than in the placebo group (62 cases). The mean (SD) length of PICU stay was obviously lowered in the VD group [11.8 (1.2) days] compared to the placebo group [15.2 (2.3 days)], whereas cases of patient death were similar between the two groups.
CONCLUSIONS


Supplementation of vitamin D effectively reduces infections of Candida in children who were critically ill and on broad-spectrum antibiotic treatment.",2019,The prevalence of candiduria as well as candidaemia was significantly lower in the VD-treated group (26 cases) than in the placebo group (62 cases).,"['paediatric intensive care units (PICUs', 'children who were critically ill and on broad-spectrum antibiotic treatment', 'paediatric intensive care unit', 'Four hundred sixteen eligible children aged between 12\xa0months to 5\xa0years old admitted to the PICU, who were on broad-spectrum antibiotic therapy, participated in the study']","['vitamin D', 'plain yogurt drink (placebo group) or supplemented with 300\xa0IU\xa0day -1  vitamin D', 'placebo', 'Vitamin D-supplemented yogurt drink']","['mean (SD) length of PICU stay', 'prevalence of candiduria as well as candidaemia', 'Candida growth in blood (candidaemia) and urine (candiduria', 'patient death', 'Candida infections', 'incidences of Candida colonisation (Candida isolated from rectal swab']","[{'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3541352', 'cui_str': 'Vitamin D supplement (substance)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0403723', 'cui_str': 'Candiduria (disorder)'}, {'cui': 'C0877445', 'cui_str': 'Candidemia'}, {'cui': 'C0006836', 'cui_str': 'Monilia'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006840', 'cui_str': 'Moniliasis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2242557', 'cui_str': 'Candida colonisation'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0444215', 'cui_str': 'Rectal swab (specimen)'}]",416.0,0.311592,The prevalence of candiduria as well as candidaemia was significantly lower in the VD-treated group (26 cases) than in the placebo group (62 cases).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jian', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': ""Nursing Department, Wuxi Children's Hospital, Wuxi, China.""}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12634']
763,30786793,Neonatal painful stimuli: skin conductance algesimeter index to measure efficacy 24% of sucrose oral solution.,"Pain management is one of the main challenges in addressing the improved care of hospitalized newborns. The administration of oral sucrose with and without non-nutritive suction has been proposed as a nonpharmacological intervention to relieve procedural pain in newborns. The effects have not yet been well characterized. The aim of this study is to investigate, using skin conductance algesimeter (SCA) pain monitor index, the effects of 24% sucrose solution on pain perception during capillary and arterial blood sampling. It is a prospective, randomized controlled study: sucrose versus placebo. Sucrose was given orally to infants who were submitted to arterial or capillary sampling. The SCA was measured during, and for 3 min before and after the intervention. Fifty-six infants were enrolled: 31 in the sucrose group and 25 in the placebo group. SCA showed that the measurement of peaks per second of pain during and 3 min after the procedures was lower in the sucrose group than the placebo group and that this difference was statistically significant ( p  < .05). In conclusion, 24% sucrose administered orally is effective in reducing pain during and after capillary and arterial sampling in newborns and can be used for the prevention and treatment of pain in the Neonatal Intensive Care Unit. Brief rationale To treat neonatal pain, a tiered approach with nonpharmacological and pharmacological method can be used.Among nonpharmacological therapies, sucrose administration is safe and effective in reducing single episodes of minor procedural pain. This study aimed to investigate, the effects of 24% sucrose solution on pain perception during capillary and arterial blood withdrawn by using an objective method: skin conductance algesimeter (SCA) pain monitor index.This randomized controlled trial in which term and/or preterm neonates (postnatal age maximum of 28 days corrected for postmenstrual age) received sucrose for procedural pain. Oral sucrose was administered directly by a disposable plastic vial. SCA was measured by means of a specific device.We demonstrated, using SCA pain monitor index, the efficacy of 24% sucrose solution on pain perception during capillary and arterial blood withdrawn. The results of this study provide an objective evidence of sucrose efficacy for the prevention and treatment of neonatal painful procedures.",2020,SCA showed that the measurement of peaks per second of pain during and 3 min after the procedures was lower in the sucrose group than the placebo group and that this difference was statistically significant (p < .05).,"['Fifty-six infants were enrolled: 31 in the sucrose group and 25 in the placebo group', 'term and/or preterm neonates (postnatal age maximum of 28 days corrected for postmenstrual age', 'neonatal painful procedures', 'hospitalized newborns', 'newborns']","['sucrose versus placebo', 'placebo', 'Oral sucrose', 'sucrose solution', '24% sucrose solution', 'oral sucrose with and without non-nutritive suction', 'Sucrose', 'SCA', 'sucrose oral solution']","['pain', 'pain perception', 'pain perception during capillary and arterial blood sampling', 'SCA', 'measurement of peaks per second of pain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C2346281', 'cui_str': 'Sucrose Oral Solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0006901', 'cui_str': 'Capillaries'}, {'cui': 'C0189587', 'cui_str': 'Arterial puncture for withdrawal of blood for diagnosis (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0565930', 'cui_str': '/s'}]",56.0,0.146944,SCA showed that the measurement of peaks per second of pain during and 3 min after the procedures was lower in the sucrose group than the placebo group and that this difference was statistically significant (p < .05).,"[{'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Passariello', 'Affiliation': 'Department of Translational Medical Science, Pediatric Section of University ""Federico II"", Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Montaldo', 'Affiliation': 'Neonatal Intensive Care Unit, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Palma', 'Affiliation': 'Department of Translational Medical Science, Pediatric Section of University ""Federico II"", Naples, Italy.'}, {'ForeName': 'Marilù', 'Initials': 'M', 'LastName': 'Cirillo', 'Affiliation': 'Neonatal Intensive Care Unit, Dei Colli Hospital, Naples, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Di Guida', 'Affiliation': 'Department of Translational Medical Science, Pediatric Section of University ""Federico II"", Naples, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Esposito', 'Affiliation': 'Department of Translational Medical Science, Pediatric Section of University ""Federico II"", Naples, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Caruso', 'Affiliation': 'Department of Translational Medical Science, Pediatric Section of University ""Federico II"", Naples, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Pugliese', 'Affiliation': 'Department of Translational Medical Science, Pediatric Section of University ""Federico II"", Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giliberti', 'Affiliation': 'Neonatal Intensive Care Unit, Dei Colli Hospital, Naples, Italy.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1580690']
764,30786792,A randomized controlled trial comparing the effect of fortification of human milk with an infant formula powder versus unfortified human milk on the growth of preterm very low birth weight infants.,,2020,,['preterm very low birth weight infants'],['fortification of human milk with an infant formula powder versus unfortified human milk'],[],"[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}]","[{'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]",[],,0.0900118,,"[{'ForeName': 'Viraraghavan Vadakkencherry', 'Initials': 'VV', 'LastName': 'Ramaswamy', 'Affiliation': 'Department of Neonatology, Nori Multi-Speciality Hospital, Vijayawada, India.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1580260']
765,30789384,Mannitol Improves Intraoperative Brain Relaxation in Patients With a Midline Shift Undergoing Supratentorial Tumor Surgery: A Randomized Controlled Trial.,"BACKGROUND


Mannitol is widely used to reduce brain tissue swelling and improve brain relaxation during neurosurgery. However, the optimal dosage for patients with midline shift undergoing supratentorial tumor resection remains unclear.
METHODS


In this randomized, controlled double-blinded study, 204 patients with preoperative midline shift who underwent elective supratentorial brain tumor surgery were equally allocated to receive placebo or 0.7, 1.0, or 1.4 g/kg mannitol infusion. The primary outcome was the proportion of satisfactory brain relaxation.
RESULTS


Demographics and baseline characteristics were similar among the 4 groups. Trend analysis showed that mannitol infusion increased satisfactory brain relaxation (P<0.0001), relaxed dural tension (P<0.0001) and adequate surgical exposure (P<0.0001), and decreased the requirement for rescue therapy for brain swelling (P<0.0005), all in a dose-dependent manner. Tumor size (odds ratio [OR]: 0.99 per 1 mm, 95% confidence interval [CI]: 0.989-0.998, P=0.004), peritumoral edema classification (OR: 0.60, 95% CI: 0.37-0.97; P=0.038) as well as mannitol dose (OR: 2.81, 95% CI: 1.97-4.02, P<0.0001) were significantly associated with satisfactory brain relaxation. An increased risk of moderate to severe postoperative cerebral edema was found in the group receiving 1.4 g/kg mannitol (P=0.025) in a dose-dependent manner (P=0.018).
CONCLUSIONS


An optimal mannitol infusion dosage of 1.0 g/kg is recommended to improve brain relaxation with lower risk of moderate to severe postoperative cerebral edema in patients with midline shift undergoing supratentorial tumor resections. The effect of mannitol on brain relaxation is affected by tumor size and severity of peritumoral edema, rather than by midline shift.",2020,"Trend analysis showed that mannitol infusion increased satisfactory brain relaxation (P<0.0001), relaxed dural tension (P<0.0001) and adequate surgical exposure (P<0.0001), and decreased the requirement for rescue therapy for brain swelling (P<0.0005), all in a dose-dependent manner.","['patients with midline shift undergoing supratentorial tumor resections', '204 patients with preoperative midline shift who underwent elective supratentorial brain tumor surgery', 'Patients With a Midline Shift Undergoing Supratentorial Tumor Surgery']","['Mannitol', 'mannitol', 'placebo', 'mannitol infusion']","['Intraoperative Brain Relaxation', 'peritumoral edema classification (OR', 'relaxed dural tension (P<0.0001) and adequate surgical exposure', 'Tumor size', 'risk of moderate to severe postoperative cerebral edema', 'brain relaxation', 'satisfactory brain relaxation', 'proportion of satisfactory brain relaxation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0038874', 'cui_str': 'Supratentorial Tumors'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1522407', 'cui_str': 'Supratentorial brain structure (body structure)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C3267127', 'cui_str': 'Peritumoural oedema'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0006114', 'cui_str': 'Cerebral Edema'}]",204.0,0.3139,"Trend analysis showed that mannitol infusion increased satisfactory brain relaxation (P<0.0001), relaxed dural tension (P<0.0001) and adequate surgical exposure (P<0.0001), and decreased the requirement for rescue therapy for brain swelling (P<0.0005), all in a dose-dependent manner.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Huihui', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Beijing Fu Xing Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Neurosurgery, Beijing Tian Tan Hospital, Capital Medical University.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Hao', 'Affiliation': 'Neurosurgery, Beijing Tian Tan Hospital, Capital Medical University.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Dexiang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Kan', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Departments of Anesthesiology.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000585']
766,28363923,Interactive web-based pulmonary rehabilitation programme: a randomised controlled feasibility trial.,"OBJECTIVES


The aim of this study was to determine if an interactive web-based pulmonary rehabilitation (PR) programme is a feasible alternative to conventional PR.
DESIGN


Randomised controlled feasibility trial.
SETTING


Participants with a diagnosis of chronic obstructive pulmonary disease were recruited from PR assessments, primary care and community rehabilitation programmes. Patients randomised to conventional rehabilitation started the programme according to the standard care at their referred site on the next available date.
PARTICIPANTS


103 patients were recruited to the study and randomised: 52 to conventional rehabilitation (mean (±SD) age 66 (±8) years, Medical Research Council (MRC) 3 (IQR2-4)); 51 to the web arm (mean (±SD) age 66 (±10) years, MRC 3 (IQR2-4)). Participants had to be willing to participate in either arm of the trial, have internet access and be web literate.
INTERVENTIONS


Patients randomised to the web-based programme worked through the website, exercising and recording their progress as well as reading educational material. Conventional PR consisted of twice weekly, 2 hourly sessions (an hour for exercise training and an hour for education).
OUTCOME MEASURES


Recruitment rates, eligibility, patient preference and dropout and completion rates for both programmes were collected. Standard outcomes for a PR assessment including measures of exercise capacity and quality of life questionnaires were also evaluated.
RESULTS


A statistically significant improvement (p≤0.01) was observed within each group in the endurance shuttle walk test (WEB: mean change 189±211.1; PR classes: mean change 184.5±247.4 s) and Chronic Respiratory disease Questionnaire-Dyspnoea (CRQ-D; WEB: mean change 0.7±1.2; PR classes: mean change 0.8±1.0). However, there were no significant differences between the groups in any outcome. Dropout rates were higher in the web-based programme (57% vs 23%).
CONCLUSIONS


An interactive web-based PR programme is feasible and acceptable when compared with conventional PR. Future trials maybe around choice-based PR programmes for select patients enabling stratification of patient care.
TRIAL REGISTRATION NUMBER


ISRCTN03142263; Results.",2017,A statistically significant improvement (p≤0.01) was observed within each group in the endurance shuttle walk test (WEB:,"['Participants with a diagnosis of chronic obstructive pulmonary disease were recruited from PR assessments, primary care and community rehabilitation programmes', '103 patients were recruited to the study and randomised: 52 to conventional rehabilitation (mean (±SD) age 66 (±8) years, Medical Research Council (MRC) 3 (IQR2-4)); 51 to the web arm (mean (±SD) age 66 (±10) years, MRC 3 (IQR2-4', 'Participants had to be willing to participate in either arm of the trial, have internet access and be web literate']","['interactive web-based PR programme', 'web-based programme worked through the website, exercising and recording their progress as well as reading educational material', 'Interactive web-based pulmonary rehabilitation programme', 'conventional rehabilitation', 'interactive web-based pulmonary rehabilitation (PR) programme']","['Dropout rates', 'Recruitment rates, eligibility, patient preference and dropout and completion rates', 'Chronic Respiratory disease Questionnaire-Dyspnoea', 'endurance shuttle walk test (WEB', 'exercise capacity and quality of life questionnaires']","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C4704731', 'cui_str': 'Internet Access'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1960627', 'cui_str': 'Endurance Shuttle Walk Test'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",103.0,0.13037,A statistically significant improvement (p≤0.01) was observed within each group in the endurance shuttle walk test (WEB:,"[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chaplin', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Hewitt', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Apps', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bankart', 'Affiliation': 'Department of Primary Care and Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pulikottil-Jacob', 'Affiliation': 'Health Sciences Research Institute, Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Boyce', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Leicester Respiratory Biomedical Research Unit, Department of Respiratory Medicine, Centre for Exercise and Rehabilitation Science, Glenfield Hospital, University Hospitals of Leicester, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2016-013682']
767,31627908,No Advantage of Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene-Covered Stents over Uncovered Nitinol Stents for Percutaneous Palliation of Malignant Infrahilar Biliary Obstruction: Results of a Single-Center Prospective Randomized Trial.,"PURPOSE


To prove that covered stents are more efficacious than uncovered stents regarding patency, safety, enabling of chemotherapy, and survival in percutaneous palliation of malignant infrahilar biliary obstruction.
MATERIALS AND METHODS


After failed endoscopic treatment, 154 patients with obstructive jaundice caused by unresectable infrahilar malignancy were randomly allocated to receive an expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent. Occlusion rate, patency, and survival were assessed. Safety and clinical success in terms of chemotherapy were compared.
RESULTS


Three patients were excluded post hoc. Fifteen patients died within 7 d and were excluded from patency analysis. Occlusion rates were 32% (21 of 66) for covered and 29% (20 of 70) for uncovered stents (P = .7). Estimated median patency durations were 308 d (95% confidence interval [CI], 178-438 d) for covered and 442 d (95% CI, 172-712 d) for uncovered stents (P = .1). Serious adverse events (P = 1.0) and 30-day mortality (P = .5) were equivalent between groups. At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001). In the covered stent group, 35 patients (48%) received palliative chemotherapy, vs 29 (37%) in the uncovered stent group (P = .2). Estimated median survival times were 96 days (95% CI, 68-124 d) with covered stents and 75 days (95% CI, 42-108 d) with uncovered stents (P = .6).
CONCLUSIONS


In malignant infrahilar biliary obstruction not amenable to endoscopy, no improvement in patency or survival with percutaneously placed covered stents could be confirmed. Covered and uncovered stent types exhibit similar safety profiles and clinical success rates.",2020,"At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001).","['154 patients with obstructive jaundice caused by unresectable infrahilar malignancy', 'Malignant Infrahilar Biliary Obstruction']","['Expanded Polytetrafluoroethylene and Fluorinated Ethylene Propylene-Covered Stents', 'expanded polytetrafluoroethylene and fluorinated ethylene propylene-covered or an uncovered nitinol stent', 'Nitinol Stents', 'palliative chemotherapy']","['Occlusion rate, patency, and survival', 'Estimated median survival times', 'patency or survival', 'Estimated median patency durations', 'Safety and clinical success', 'median bilirubin reduction', 'Serious adverse events', '30-day mortality', 'Occlusion rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0382943', 'cui_str': 'poly(tetrafluoroethylene-co-hexafluoropropylene)'}, {'cui': 'C1322797', 'cui_str': 'Covered Stent'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",154.0,0.269582,"At hospital discharge, median bilirubin reduction of 8 mg/dL was found in both groups (P < .001).","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium. Electronic address: elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Man', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Huyck', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.07.013']
768,32407654,Caffeine increases peripheral fatigue in low- but not in high-performing cyclists.,"The influence of cyclists' performance levels on caffeine-induced increases in neuromuscular fatigue after a 4-km cycling time trial (TT) was investigated. Nineteen cyclists performed a 4-km cycling TT 1 h after ingesting caffeine (5 mg·kg -1 ) or placebo (cellulose). Changes from baseline to after exercise in voluntary activation (VA) and potentiated 1 Hz force twitch ( Q tw,pot ) were used as markers of central and peripheral fatigue, respectively. Participants were classified as ""high performing"" (HP,  n  = 8) or ""low performing"" (LP,  n  = 8) in accordance with their performance in a placebo trial. Compared with placebo, caffeine increased the power, anaerobic mechanical power, and anaerobic work, reducing the time to complete the trial in both groups ( p  < 0.05). There was a group versus supplement and a group versus supplement versus trial interaction for  Q tw,pot , in which the postexercise reduction was greater after caffeine compared with placebo in the LP group ( Q tw,pot  = -34% ± 17% vs. -21% ± 11%,  p  = 0.02) but not in the HP group ( Q tw,pot  = -22% ± 8% vs. -23% ± 10%,  p  = 0.64). There was no effect of caffeine on VA, but there was a group versus trial interaction with lower postexercise values in the LP group than in the HP group ( p  = 0.03). Caffeine-induced improvement in 4-km cycling TT performance seems to come at the expense of greater locomotor muscle fatigue in LP but not in HP cyclists.  Novelty  Caffeine improves exercise performance at the expense of a greater end-exercise peripheral fatigue in low-performing athletes. Caffeine-induced improvement in exercise performance does not affect end-exercise peripheral fatigue in high-performing athletes. High-performing athletes seem to have augmented tolerance to central fatigue during a high-intensity time trial.",2020,"Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05).",['Nineteen cyclists'],"['High', 'caffeine', 'Caffeine', 'placebo in LP', 'caffeine (5 mg‧kg-1) or placebo (cellulose', 'placebo, caffeine']","['4-km cycling TT performance', 'Peripheral Fatigue', 'locomotor muscle fatigue', 'anaerobic mechanical power and the anaerobic work', 'neuromuscular fatigue', 'exercise performance']","[{'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0234116', 'cui_str': 'Neuromuscular fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",19.0,0.100991,"Compared with placebo, caffeine increased the power, the anaerobic mechanical power and the anaerobic work, reducing the time to complete the trial for both groups (p<0.05).","[{'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Santos', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Felippe', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Guilherme A', 'Initials': 'GA', 'LastName': 'Ferreira', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Learsi', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}, {'ForeName': 'Patrícia G', 'Initials': 'PG', 'LastName': 'Couto', 'Affiliation': 'Endurance Sports Research Group (GEDAE-USP), University of São Paulo, São Paulo, SP 05508-030, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Sports Research Group (GEDAE-USP), University of São Paulo, São Paulo, SP 05508-030, Brazil.'}, {'ForeName': 'Gleber', 'Initials': 'G', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Education, Federal University of Parana, Curitiba, PR 81531-980, Brazil.'}, {'ForeName': 'Adriano E', 'Initials': 'AE', 'LastName': 'Lima-Silva', 'Affiliation': 'Human Performance Research Group, Academic Department of Physical Education, Federal University of Technology - Parana (UTFPR), Neoville, Curitiba, PR 81310-900, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0992']
769,30772477,Long-Term Outcomes with Subcutaneous C1-Inhibitor Replacement Therapy for Prevention of Hereditary Angioedema Attacks.,"BACKGROUND


For the prevention of attacks of hereditary angioedema (HAE), the efficacy and safety of subcutaneous human C1-esterase inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) was established in the 16-week Clinical Study for Optimal Management of Preventing Angioedema with Low-Volume Subcutaneous C1-Inhibitor Replacement Therapy (COMPACT).
OBJECTIVE


To assess the long-term safety, occurrence of angioedema attacks, and use of rescue medication with C1-INH(SC).
METHODS


Open-label, randomized, parallel-arm extension of COMPACT across 11 countries. Patients with frequent angioedema attacks, either study treatment-naive or who had completed COMPACT, were randomly assigned (1:1) to 40 IU/kg or 60 IU/kg C1-INH(SC) twice per week, with conditional uptitration to optimize prophylaxis (ClinicalTrials.gov registration no. NCT02316353).
RESULTS


A total of 126 patients with a monthly attack rate of 4.3 in 3 months before entry in COMPACT were enrolled and treated for a mean of 1.5 years; 44 patients (34.9%) had more than 2 years of exposure. Mean steady-state C1-INH functional activity increased to 66.6% with 60 IU/kg. Incidence of adverse events was low and similar in both dose groups (11.3 and 8.5 events per patient-year for 40 IU/kg and 60 IU/kg, respectively). For 40 IU/kg and 60 IU/kg, median annualized attack rates were 1.3 and 1.0, respectively, and median rescue medication use was 0.2 and 0.0 times per year, respectively. Of 23 patients receiving 60 IU/kg for more than 2 years, 19 (83%) were attack-free during months 25 to 30 of treatment.
CONCLUSIONS


In patients with frequent HAE attacks, long-term replacement therapy with C1-INH(SC) is safe and exhibits a substantial and sustained prophylactic effect, with the vast majority of patients becoming free from debilitating disease symptoms.",2019,"Incidence of adverse events was low and similar in both dose groups (11.3 and 8.5 events per patient-year for 40 IU/kg and 60 IU/kg, respectively).","['across 11 countries', '126 patients with a monthly attack rate of 4.3 in 3 months before entry in COMPACT were enrolled and treated for a mean of 1.5 years; 44 patients (34.9%) had more than 2 years of exposure', 'Patients with frequent angioedema attacks, either study treatment-naive or who had completed COMPACT', '23 patients receiving 60 IU/kg for more than 2 years, 19 (83%) were attack-free during months 25 to 30 of treatment', 'Angioedema with Low-Volume Subcutaneous C1-Inhibitor Replacement Therapy (COMPACT']","['C1-INH(SC', 'Subcutaneous C1-Inhibitor Replacement Therapy', 'subcutaneous human C1-esterase inhibitor (C1-INH[SC', 'COMPACT']","['Incidence of adverse events', 'Mean steady-state C1-INH functional activity', 'median annualized attack rates', 'Hereditary Angioedema Attacks']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1869027', 'cui_str': 'Angioedema (SMQ)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 inhibitor antigen measurement'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C1446194', 'cui_str': 'Serum C1 inhibitor antigen measurement'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}, {'cui': 'C2366367', 'cui_str': 'C1 esterase inhibitor (human)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0540301', 'cui_str': 'C1-INH'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}]",126.0,0.106803,"Incidence of adverse events was low and similar in both dose groups (11.3 and 8.5 events per patient-year for 40 IU/kg and 60 IU/kg, respectively).","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craig', 'Affiliation': 'Department of Medicine, Pediatrics and Graduate Studies, Penn State University Hershey Medical Center, Hershey, Pa. Electronic address: tcraig@psu.edu.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Zuraw', 'Affiliation': 'Department of Medicine, University of California San Diego and San Diego VA Healthcare, La Jolla, Calif.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Longhurst', 'Affiliation': 'Immunology Department, Barts Health NHS Trust, The Royal London Hospital, London, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cicardi', 'Affiliation': 'Department of Biomedical and Clinical Sciences, ""L. Sacco"" University of Milan/ASST Fatebenefratelli-Sacco, Milan, Italy.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Bork', 'Affiliation': 'Department of Dermatology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Grattan', 'Affiliation': ""St John's Institute of Dermatology, Tower Wing Guy's Hospital, London, United Kingdom.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Katelaris', 'Affiliation': 'Department of Medicine, Immunology and Allergy, Campbelltown Hospital, Campbelltown, NSW, Australia.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Gordon Sussman Clinical Research, Inc, Toronto, ON, Canada.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Keith', 'Affiliation': 'McMaster University Medical Center Site, Hamilton, ON, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corp, Ottawa, ON, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Hébert', 'Affiliation': 'Clinique Specialisée en Allergie de la Capitale (CSAC), Québec, QC, Canada.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hanzlikova', 'Affiliation': 'Fakultni nemocnice Plzen - Ustav Imunologie a Alergologie, Plzen, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Staubach-Renz', 'Affiliation': 'Clinical Research Centre, Hautklinik und Poliklinik der Universitätsklinik Mainz, Mainz, Germany.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Martinez-Saguer', 'Affiliation': 'HZRM Haemophilia Center Rhein Main, Moerfelden-Walldorf, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Magerl', 'Affiliation': 'Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Avner', 'Initials': 'A', 'LastName': 'Reshef', 'Affiliation': 'Barzilai University Medical Center, Allergy, Immunology & Angioedema, Ashkelon, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Kivity', 'Affiliation': 'Tel Aviv Sourasky Medical Center, Allergy and Immunology Unit, Tel Aviv, Israel.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Neri', 'Affiliation': 'Dipartimento di Medicina Interna, Azienda Ospedaliero - Universitaria ""Policlinico - Vittorio Emanuele,"" Catania, Italy.'}, {'ForeName': 'Ioana', 'Initials': 'I', 'LastName': 'Crisan', 'Affiliation': 'Spitalul Clinic Municipal Cluj, Cluj Napoca, Romania.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Caballero', 'Affiliation': 'Servicio de Alergia, Hospital, La Paz Institute for Health Research (IdiPaz), Centro de Investigacion Biomédica en Red de Enfermedades Raras (CIBERER)-U754, Madrid, Spain.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Baeza', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Servicio de Alergología, Instituto de Investigación Gregorio Marañón, Centro de Investigacion Biomédica en Red de Enfermedades Raras (CIBERER)-U761, Madrid, Spain.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Hernandez', 'Affiliation': 'Hospital Universitario La Fe, Servicio de Alergia, Bulevar del Sur, Valencia, Spain.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, Chevy Chase, Md.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, Dallas, Texas.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center LLC, Cincinnati, Ohio.'}, {'ForeName': 'Iftikar', 'Initials': 'I', 'LastName': 'Hussain', 'Affiliation': 'Allergy, Asthma and Immunology Center, Tulsa, Okla.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Alabama Allergy & Asthma, Birmingham, Ala.'}, {'ForeName': 'Lawrence B', 'Initials': 'LB', 'LastName': 'Schwartz', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Va.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'Allergy & Asthma Clinical Research, Walnut Creek, Calif.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manning', 'Affiliation': 'Medical Research of Arizona, Scottsdale, Ariz.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Levy', 'Affiliation': 'Dr Donald Levy, MD, Orange, Calif.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Riedl', 'Affiliation': 'Clinical Allergy and Immunology Section, University of California San Diego School of Medicine, La Jolla, Calif.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Christiansen', 'Affiliation': 'Clinical Allergy and Immunology Section, University of California San Diego School of Medicine, La Jolla, Calif.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Feuersenger', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Pragst', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mycroft', 'Affiliation': 'CSL Behring LLC, King of Prussia, Pa.'}, {'ForeName': 'Dipti', 'Initials': 'D', 'LastName': 'Pawaskar', 'Affiliation': 'CSL Behring LLC, King of Prussia, Pa.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': 'CSL Behring LLC, King of Prussia, Pa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.054']
770,30462220,Edoxaban and implantable cardiac device interventions: insights from the ENGAGE AF-TIMI 48 trial.,"Aims


Pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy device implantations and generator changes are frequently performed in patients receiving direct oral anticoagulants. In an exploratory analysis, we investigated the outcome of patients undergoing such device procedures in the ENGAGE AF-TIMI 48 trial.
Methods and results


During the trial, 1217 device procedures were performed in 1145 patients, with intervention dates available for 1203 procedures. Two hundred and twenty-five procedures (in 212 patients) were performed >30 days after study drug was stopped and are not included in the event analysis. For most interventions (n = 728, 74%), study drug was interrupted >3 days (median for the entire cohort: 5 days, interquartile range 0-11 days); 250 interventions were performed with ≤3 days study drug interruption. During the first 30 days after the procedure, six strokes/systemic embolic events (SEEs) (three each in the lower-dose edoxaban and warfarin arm) and one major bleeding event (in the lower-dose edoxaban arm) occurred; no stroke/SEEs or major bleeds occurred around the 295 device procedures in the higher-dose edoxaban arm. Two ischaemic and one major bleeding event occurred after the 288 device procedures performed with ≤3 days periprocedural interruption of study drug.
Conclusion


In this first experience of patients undergoing device surgery with edoxaban, a low risk of ischaemic and bleeding events was observed during the first 30 days post-procedure. Our data are in line with current recommendations of no or only brief interruption of non-vitamin K antagonist oral anticoagulants prior to cardiac device surgery.",2019,"Two ischaemic and one major bleeding event occurred after the 288 device procedures performed with ≤3 days periprocedural interruption of study drug.
","['patients undergoing device surgery with', 'patients receiving direct oral anticoagulants', '1217 device procedures were performed in 1145 patients, with intervention dates available for 1203 procedures', 'Two hundred and twenty-five procedures (in 212 patients', 'patients undergoing such device procedures in the ENGAGE AF-TIMI 48 trial']","['edoxaban', 'Edoxaban', 'implantable cardioverter-defibrillator, and cardiac resynchronization therapy device implantations']","['low risk of ischaemic and bleeding events', 'stroke/SEEs or major bleeds', 'systemic embolic events (SEEs', 'major bleeding event']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C2936377', 'cui_str': 'Cardiac Resynchronization Therapy Devices'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",1145.0,0.0907969,"Two ischaemic and one major bleeding event occurred after the 288 device procedures performed with ≤3 days periprocedural interruption of study drug.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Steffel', 'Affiliation': 'Department of Cardiology, University Heart Center Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""Cardiovascular Division, TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Avenue, 1st Floor Offices, Boston, MA 02115, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Cardiovascular Division, TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Avenue, 1st Floor Offices, Boston, MA 02115, USA.""}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Hamershock', 'Affiliation': ""Cardiovascular Division, TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Avenue, 1st Floor Offices, Boston, MA 02115, USA.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""Cardiovascular Division, TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Avenue, 1st Floor Offices, Boston, MA 02115, USA.""}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Nieminen', 'Affiliation': 'University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi-Sankyo Europe GmbH, Munich, Germany.'}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Baskin Ridge, NJ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Peterson', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Baskin Ridge, NJ, USA.'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""Cardiovascular Division, TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Avenue, 1st Floor Offices, Boston, MA 02115, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Cardiovascular Division, TIMI Study Group, Brigham and Women's Hospital, 350 Longwood Avenue, 1st Floor Offices, Boston, MA 02115, USA.""}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy253']
771,27855099,Cluster randomised feasibility trial to improve the Control of Hypertension In Rural India (CHIRI): a study protocol.,"INTRODUCTION


Hypertension is emerging in rural populations of India. Barriers to diagnosis and treatment of hypertension may differ regionally according to economic development. Our main objectives are to estimate the prevalence, awareness, treatment and control of hypertension in 3 diverse regions of rural India; identify barriers to diagnosis and treatment in each setting and evaluate the feasibility of a community-based intervention to improve control of hypertension.
METHODS AND ANALYSIS


This study includes 4 main activities: (1) assessment of risk factors, quality of life, socioeconomic position and barriers to changes in lifestyle behaviours in ∼14 500 participants; (2) focus group discussions with individuals with hypertension and indepth interviews with healthcare providers, to identify barriers to control of hypertension; (3) use of a medicines-availability survey to determine the availability, affordability and accessibility of medicines and (4) trial of an intervention provided by Accredited Social Health Activists (ASHAs), comprising group-based education and support for individuals with hypertension to self-manage blood pressure. Wards/villages/hamlets of a larger Mandal are identified as the primary sampling unit (PSU). PSUs are then randomly selected for inclusion in the cross-sectional survey, with further randomisation to intervention or control. Changes in knowledge of hypertension and risk factors, and clinical and anthropometric measures, are assessed. Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs.
ETHICS AND DISSEMINATION


Approval for the overall study was obtained from the Health Ministry's Screening Committee, Ministry of Health and Family Welfare (India), institutional review boards at each site and Monash University. In addition to publication in peer-reviewed articles, results will be shared with federal, state and local government health officers, local healthcare providers and communities.
TRIAL REGISTRATION NUMBER


CTRI/2016/02/006678; Pre-results.",2016,"Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs.
","['in ∼14\u2005500 participants; (2) focus group discussions with individuals with hypertension and indepth interviews with healthcare providers, to identify barriers to control of hypertension; (3) use of a medicines-availability survey to determine the availability, affordability and accessibility of medicines and (4) trial of an']","['intervention provided by Accredited Social Health Activists (ASHAs), comprising group-based education and support for individuals with hypertension to self-manage blood pressure']","['risk factors, quality of life, socioeconomic position and barriers to changes in lifestyle behaviours', 'Hypertension', 'knowledge of hypertension and risk factors, and clinical and anthropometric measures']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0814630', 'cui_str': 'Affordabilities'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272452', 'cui_str': 'Manage blood pressure taking'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0412749,"Evaluation of the intervention by participants provides insight into perceptions of education and support of self-management delivered by the ASHAs.
","[{'ForeName': 'Michaela A', 'Initials': 'MA', 'LastName': 'Riddell', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rohina', 'Initials': 'R', 'LastName': 'Joshi', 'Affiliation': 'The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': 'School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Thomas', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Velandai K', 'Initials': 'VK', 'LastName': 'Srikanth', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Evans', 'Affiliation': 'Department of Physiology, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Kalyanram', 'Affiliation': 'Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India.'}, {'ForeName': 'Kamakshi', 'Initials': 'K', 'LastName': 'Kartik', 'Affiliation': 'Rishi Valley Rural Health Centre, Chittoor District, Andhra Pradesh, India.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'George Institute for Global Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Arabshahi', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'R P', 'Initials': 'RP', 'LastName': 'Varma', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Rama K', 'Initials': 'RK', 'LastName': 'Guggilla', 'Affiliation': 'George Institute for Global Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Oduru', 'Initials': 'O', 'LastName': 'Suresh', 'Affiliation': 'The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'G K', 'Initials': 'GK', 'LastName': 'Mini', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': ""D'Esposito"", 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alim', 'Affiliation': 'George Institute for Global Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Amanda G', 'Initials': 'AG', 'LastName': 'Thrift', 'Affiliation': 'School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2016-012404']
772,28631250,Lactobacillus salivarius NK02: a Potent Probiotic for Clinical Application in Mouthwash.,"A specific strain of naturally occurring oral lactobacilli was isolated and identified based on morphological, biochemical, and 16S rRNA gene sequencing. The phylogenetic affiliation of the isolate confirmed that the NK02 strain had close association with the Lactobacillus salivarius. An effective mouthwash was developed for treatment of periodontitis and suppression of the indicator bacterium Aggregatibacter actinomycetemcomitans which is an obvious pathogen of periodontal disease. The mouthwash containing L. salivarius NK02 was tested at a dose level of 10 8  (colony forming units (CFU) ml -1 ), monitoring over a period of 4 weeks. The study was a randomized double-blind placebo control trial, and the patients were treated in two groups of control and test by using scaling and root planing (SRP) + placebo and scaling and root planing (SRP) + probiotic, respectively. It appeared that the probiotic mouthwash was able to inhibit the bacterial growth on both saliva and sub-gingival crevice and exhibited antibacterial activity against A. actinomycetemcomitans. The results also showed that SRP+ probiotic treatment led to a significant decrease of gingival index (GI) and bleeding on probing (BOP) compared with that of SRP + placebo for the probiotic group. The rate of decrease in pocket depth was displayed in the group with SRP + probiotic treatment equal to 1/2 mm, and probing pocket depth (PPD) value was decreased in the probiotic bacteria treatment group that can explain the decrease in inflammation in gingiva. Our findings suggest that probiotic mouthwash is healthy for daily use as an alternative for maintaining dental and periodontal health.",2018,The results also showed that SRP+ probiotic treatment led to a significant decrease of gingival index (GI) and bleeding on probing (BOP) compared with that of SRP + placebo for the probiotic group.,[],"['mouthwash containing L. salivarius NK02', 'placebo', 'SRP+ probiotic', 'scaling and root planing (SRP) + placebo and scaling and root planing (SRP) + probiotic, respectively', 'Lactobacillus salivarius NK02', 'SRP + placebo']","['gingival index (GI) and bleeding on probing (BOP', 'inflammation in gingiva', 'rate of decrease in pocket depth', 'probing pocket depth (PPD) value']",[],"[{'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0317593', 'cui_str': 'Lactobacillus salivarius'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.099428,The results also showed that SRP+ probiotic treatment led to a significant decrease of gingival index (GI) and bleeding on probing (BOP) compared with that of SRP + placebo for the probiotic group.,"[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Sajedinejad', 'Affiliation': 'Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Paknejad', 'Affiliation': 'Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Houshmand', 'Affiliation': 'Faculty of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hakimeh', 'Initials': 'H', 'LastName': 'Sharafi', 'Affiliation': 'Division of Environmental & Industrial Biotechnology, National Institute of Genetic Engineering and Biotechnology (NIGEB), P.O. Box 14155-6343, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Jelodar', 'Affiliation': 'Faculty of Dentistry, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Shahbani Zahiri', 'Affiliation': 'Division of Environmental & Industrial Biotechnology, National Institute of Genetic Engineering and Biotechnology (NIGEB), P.O. Box 14155-6343, Tehran, Iran.'}, {'ForeName': 'Kambiz Akbari', 'Initials': 'KA', 'LastName': 'Noghabi', 'Affiliation': 'Division of Environmental & Industrial Biotechnology, National Institute of Genetic Engineering and Biotechnology (NIGEB), P.O. Box 14155-6343, Tehran, Iran. Akbari@nigeb.ac.ir.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-017-9296-4']
773,28759333,Do Pattern-Focused Visuals Improve Skin Self-Examination Performance? Explicating the Visual Skill Acquisition Model.,"Skin self-examination (SSE) consists of routinely checking the body for atypical moles that might be cancerous. Identifying atypical moles is a visual task; thus, SSE training materials utilize pattern-focused visuals to cultivate this skill. Despite widespread use, researchers have yet to explicate how pattern-focused visuals cultivate visual skill. Using eye tracking to capture the visual scanpaths of a sample of laypersons (N = 92), the current study employed a 2 (pattern: ABCDE vs. ugly duckling sign [UDS]) × 2 (presentation: photorealistic images vs. illustrations) factorial design to assess whether and how pattern-focused visuals can increase layperson accuracy in identifying atypical moles. Overall, illustrations resulted in greater sensitivity, while photos resulted in greater specificity. The UDS × photorealistic condition showed greatest specificity. For those in the photo condition with high self-efficacy, UDS increased specificity directly. For those in the photo condition with self-efficacy levels at the mean or lower, there was a conditional indirect effect such that these individuals spent a larger amount of their viewing time observing the atypical moles, and time on target was positively related to specificity. Illustrations provided significant gains in specificity for those with low-to-moderate self-efficacy by increasing total fixation time on the atypical moles. Findings suggest that maximizing visual processing efficiency could enhance existing SSE training techniques.",2017,Illustrations provided significant gains in specificity for those with low-to-moderate self-efficacy by increasing total fixation time on the atypical moles.,[],"['ABCDE vs. ugly duckling sign [UDS', 'Skin self-examination (SSE']","['layperson accuracy', 'Skin Self-Examination Performance', 'total fixation time']",[],"[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1444170', 'cui_str': 'Skin self-examination'}]","[{'cui': 'C1444170', 'cui_str': 'Skin self-examination'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0139209,Illustrations provided significant gains in specificity for those with low-to-moderate self-efficacy by increasing total fixation time on the atypical moles.,"[{'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'John', 'Affiliation': 'a School of Communication , Brigham Young University , Provo , Utah , USA.'}, {'ForeName': 'Jakob D', 'Initials': 'JD', 'LastName': 'Jensen', 'Affiliation': 'b Department of Communication , University of Utah , Salt Lake City , Utah , USA.'}, {'ForeName': 'Andy J', 'Initials': 'AJ', 'LastName': 'King', 'Affiliation': 'd Department of Public Relations , Texas Tech University , Lubbock , Texas , USA.'}, {'ForeName': 'Chelsea L', 'Initials': 'CL', 'LastName': 'Ratcliff', 'Affiliation': 'b Department of Communication , University of Utah , Salt Lake City , Utah , USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': 'e Departments of Dermatology and Oncological Sciences , University of Utah , Salt Lake City , Utah , USA.'}]",Journal of health communication,['10.1080/10810730.2017.1344750']
774,30718802,"Cryotherapy as prophylaxis against oral mucositis after high-dose melphalan and autologous stem cell transplantation for myeloma: a randomised, open-label, phase 3, non-inferiority trial.","The conditioning therapy used in connection with haematopoietic stem cell transplantation (HSCT) can induce painful oral mucositis, which has negative impacts on patient quality of life and survival, as well as on health-care costs. While cooling of the oral mucosa (cryotherapy) is regarded as standard prophylaxis against oral mucositis, the long duration of the treatment affects compliance owing to side effects. In this prospective, randomised trial, 94 patients (62 males/32 females; median age 59 years, range 34-69) with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 h (N = 46) or 2 h (N = 48). Oral mucositis was evaluated prospectively. No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively; 95% CI -0.09 to 0.049; p = 0.98) as between the groups. Two hours of cryotherapy was as effective as 7 h in terms of protecting against severe oral mucositis in connection with autologous HSCT for myeloma. This trial is registered with ClinicalTrials.gov (NCT03704597).",2019,"No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively;","['myeloma', '94 patients (62 males/32 females; median age 59 years, range 34-69) with a diagnosis of myeloma who were undergoing autologous HSCT']","['haematopoietic stem cell transplantation (HSCT', 'oral mucosa (cryotherapy', 'cryotherapy', 'Cryotherapy', 'melphalan and autologous stem cell transplantation']","['WHO scale', 'Oral mucositis']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}]","[{'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026639', 'cui_str': 'Oral Mucosa'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]","[{'cui': 'C0222045'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}]",94.0,0.0395796,"No significant difference was observed with respect to the proportion of patients who showed grades 3 and 4 toxicity according to the WHO scale (2.1 and 4.3% for 2 and 7 h, respectively;","[{'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Johansson', 'Affiliation': 'Department of Haematology, Sahlgrenska University Hospital, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden. jan-erik.j.johansson@vgregion.se.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bratel', 'Affiliation': 'Specialist clinic for Hospital Dentistry/Oral Medicine, Göteborg, Public Dental Service, Region Västra Götaland, Göteborg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hardling', 'Affiliation': 'Department of Haematology, Uddevalla Hospital, Uddevalla, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Heikki', 'Affiliation': 'Specialist Clinic for Hospital Dentistry, South Älvsborg Hospital, Borås, Sweden.'}, {'ForeName': 'Ulf-Henrik', 'Initials': 'UH', 'LastName': 'Mellqvist', 'Affiliation': 'Department of Haematology, South Älvsborg Hospital, Borås, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Hasséus', 'Affiliation': 'Department of Oral Medicine and Pathology, Institute of Odontology, The Sahlgrenska Academy at Göteborg University, Göteborg, Sweden.'}]",Bone marrow transplantation,['10.1038/s41409-019-0468-6']
775,29982562,Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events.,"Aims


This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF).
Methods and results


We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428).
Conclusion


Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.",2019,Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.,"['661 patients undergoing post-ablation magnetic resonance (MR) imaging', 'catheter ablation of atrial fibrillation', 'NVAF patients undergoing catheter ablation', '846 NVAF patients receiving DOACs prior to ablation to uninterruption (n\u2009=\u2009422) or interruption (n\u2009=\u2009424) of the DOACs on the day of the procedure', 'patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF']","['uninterrupted DOAC', 'Uninterrupted vs. interrupted periprocedural direct oral anticoagulants', 'uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs']","['safety and efficacy', 'percentage of SCILs with disappearance', 'composite of symptomatic thromboembolisms and major bleeding events', 'incidence of SCILs', 'incidence of major and minor bleeding', 'symptomatic and silent thromboembolisms and major and minor bleeding events', 'low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events', 'Silent cerebral ischaemic lesions (SCILs', 'major bleeding events', 'transient ischaemic attack (TIA) and 2 major bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]",846.0,0.050415,Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.,"[{'ForeName': 'Kohki', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Shigeto', 'Initials': 'S', 'LastName': 'Naito', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Takehito', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Take', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Minami', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Kitagawa', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Motoda', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Mitsuho', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Otsuka', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Katsura', 'Initials': 'K', 'LastName': 'Niijima', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Yamashita', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Yoshinao', 'Initials': 'Y', 'LastName': 'Sugai', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kumagai', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Koyama', 'Affiliation': 'Division of Radiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}, {'ForeName': 'Nobusada', 'Initials': 'N', 'LastName': 'Funabashi', 'Affiliation': 'Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Oshima', 'Affiliation': 'Division of Cardiology, Gunma Prefectural Cardiovascular Center, 3-12 Kameizumi-machi, Maebashi City, Gunma, Japan.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euy148']
776,31693879,The DAPA-HF Trial: A Momentous Victory in the War against Heart Failure.,"In a randomized trial of patients with heart failure and reduced ejection fraction, the SGLT2 inhibitor dapagliflozin markedly reduced mortality and worsening heart failure (McMurray et al., 2019). Remarkably, these benefits seemed to be similar in people with and without diabetes. These data usher in a new paradigm in the treatment of heart failure.",2019,"In a randomized trial of patients with heart failure and reduced ejection fraction, the SGLT2 inhibitor dapagliflozin markedly reduced mortality and worsening heart failure","['patients with heart failure and reduced ejection fraction, the']",['SGLT2 inhibitor dapagliflozin'],['mortality and worsening heart failure'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.0299736,"In a randomized trial of patients with heart failure and reduced ejection fraction, the SGLT2 inhibitor dapagliflozin markedly reduced mortality and worsening heart failure","[{'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: dlbhattmd@post.harvard.edu.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Departments of Surgery, and Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Cell metabolism,['10.1016/j.cmet.2019.10.008']
777,31706886,The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis.,"PURPOSE


To present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs).
MATERIALS AND METHODS


Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit.
RESULTS


Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P = .02) at 9 months, 44% ± 5 vs 36% ± 4 (P = .04) at 12 months, 34% ± 5 vs 28% ± 4 (P = .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P = .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P = .27). Post hoc analyses showed equivalent DCB effect in all subgroups.
CONCLUSIONS


Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs.",2020,"Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19).","['Twenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm', 'hemodialysis arteriovenous fistulae (AVFs', 'Arteriovenous Fistula Stenosis', 'Ninety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study']","['DCB angioplasty', 'Paclitaxel-Coated Balloons', 'paclitaxel-coated vs uncoated balloon angioplasty', 'ultra-high-pressure percutaneous transluminal angioplasty (PTA']","['maintain target lesion patency', 'Mortality', 'Target lesion primary patency (TLPP) rates', 'equivalent DCB effect', 'Mean time to TLPP event', 'successful vessel preparation']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous (qualifier value)'}, {'cui': 'C0340908', 'cui_str': 'Arteriovenous fistula stenosis (disorder)'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}]","[{'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}]",285.0,0.122314,"Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19).","[{'ForeName': 'Scott O', 'Initials': 'SO', 'LastName': 'Trerotola', 'Affiliation': 'Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, 1 Silverstein, 3400 Spruce St., Philadelphia, PA 19104. Electronic address: streroto@uphs.upenn.edu.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Saad', 'Affiliation': 'Section of Renal and Hypertensive Diseases, Christiana Care Health System, Newark, Delaware.'}, {'ForeName': 'Prabir', 'Initials': 'P', 'LastName': 'Roy-Chaudhury', 'Affiliation': 'University of North Carolina Kidney Center, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.08.035']
778,29463586,"Evaluation of a complex intervention (Engager) for prisoners with common mental health problems, near to and after release: study protocol for a randomised controlled trial.","INTRODUCTION


The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community. The trial will evaluate the clinical and cost-effectiveness of the Engager intervention.
METHODS AND ANALYSIS


The study is a parallel two-group randomised controlled trial with 1:1 individual allocation to either: (a) the Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England). Two hundred and eighty prisoners meeting eligibility criteria will take part. Engager is a person-centred complex intervention delivered by practitioners and aimed at addressing offenders' mental health and social care needs. It comprises one-to-one support for participants prior to release from prison and for up to 20 weeks postrelease. The primary outcome is change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6 months postrelease. Secondary outcomes include: assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life measured at 3, 6 and 12 months postrelease; change in objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism at 12 months postrelease. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness.
ETHICS AND DISSEMINATION


This study has been approved by the Wales Research Ethics Committee 3 (ref: 15/WA/0314) and the National Offender Management Service (ref: 2015-283). Findings will be disseminated to commissioners, clinicians and service users via papers and presentations.
TRIAL REGISTRATION NUMBER


ISRCTN11707331; Pre-results.",2018,The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community.,"['Two hundred and eighty prisoners meeting eligibility criteria will take part', '15/WA/0314) and the National Offender Management Service', 'prisoners with common mental health problems']","['Engager intervention plus standard care (intervention group) or (b) standard care alone (control group) across two investigation centres (South West and North West of England', 'complex intervention (Engager']","[' assessment of subjective met/unmet need, drug and alcohol use, health-related quality of life and well-being-related quality of life', 'change in psychological distress measured by the Clinical Outcomes in Routine Evaluation-Outcome Measure at 6\u2009months postrelease', 'objective social domains, drug and alcohol dependence, service utilisation and perceived helpfulness of services and change in psychological constructs related to desistence at 6 and 12 months postrelease; and recidivism']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}]",,0.135671,The 'Engager' programme is a 'through-the-gate' intervention designed to support prisoners with common mental health problems as they transition from prison back into the community.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Kirkpatrick', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Lennox', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maguire', 'Affiliation': 'Centre for Criminology, University of South Wales, Pontypridd, Wales.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Haddad', 'Affiliation': 'School of Health Sciences, City, University of London, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'UCL Centre for Behaviour Change, University College London, London, UK.'}, {'ForeName': 'Christabel', 'Initials': 'C', 'LastName': 'Owens', 'Affiliation': 'Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Durcan', 'Affiliation': 'Criminal Justice Programme, Centre for Mental Health, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Stirzaker', 'Affiliation': 'LIFT Psychology Service, Avon & Wiltshire Mental Health Partnership NHS Trust, Swindon, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Henley', 'Affiliation': 'Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Stevenson', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Carroll', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Sarah Louise', 'Initials': 'SL', 'LastName': 'Brand', 'Affiliation': 'Y Lab, Cardiff University, Cardiff, Wales, UK.'}, {'ForeName': 'Tirril', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Institute of Psychiatry, Kings College London, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Stewart', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rybczynska-Bunt', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Greer', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Shaw', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Byng', 'Affiliation': 'Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth University, Plymouth, UK.'}]",BMJ open,['10.1136/bmjopen-2017-017931']
779,31623493,Immediate and controlled-release pregabalin for the treatment of epilepsy.,"Introduction : Epilepsy is a common neurological disease requiring complex therapies, which are unable to achieve seizure control in 30% of patients. Poor adherence has been recognized as a possible determinant of drug-resistance. Prolonged-release formulations of antiepileptic drugs might help increase adherence and minimize side effects. Areas covered : Pregabalin (PGB) has peculiar pharmacodynamics and almost ideal pharmacokinetics, except for a short half-life and therefore requiring multiple daily dosing. PGB immediate-release (IR) is effective in focal-onset epilepsy (FOE), neuropathic pain, generalized anxiety disorder, and fibromyalgia, despite some tolerability issues, especially at higher doses. The controlled-release formulation (CR) shares PGB IR advantages and requires slight dose adjustments to guarantee bioavailability. In 2014, PGB CR (165 and 330 mg/day) failed to prove superior to placebo in a randomized placebo-controlled trial on 323 subjects with drug-resistant FOE, although it was just as tolerable. Therefore, PGB CR is not currently licensed for epilepsy. Expert opinion : Considering the disappointing results of the only controlled trial, PGB CR is unlikely to become an established epilepsy treatment anytime soon. Nevertheless, given its peculiar properties and potential advantages, PGB (in either formulation) should be further evaluated in specific populations of patients, especially fragile subjects with several comorbidities and complex polytherapies.",2019,The controlled-release formulation (PGB CR) shares PGB IR advantages and requires slight dose adjustments to guarantee bioavailability.,"['epilepsy', '323 subjects with drug-resistant FOE']","['placebo', 'Pregabalin (PGB', 'PGB immediate-release (IR', 'PGB CR']",[],"[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0033557', 'cui_str': 'PGB'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",[],323.0,0.015637,The controlled-release formulation (PGB CR) shares PGB IR advantages and requires slight dose adjustments to guarantee bioavailability.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morano', 'Affiliation': 'Neurology Unit, Department of Human Neurosciences, ""Sapienza"" University, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Palleria', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Citraro', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nesci', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'De Caro', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Anna Teresa', 'Initials': 'AT', 'LastName': 'Giallonardo', 'Affiliation': 'Neurology Unit, Department of Human Neurosciences, ""Sapienza"" University, Rome, Italy.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'De Sarro', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Russo', 'Affiliation': 'Science of Health Department, School of Medicine, University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Bonaventura', 'Affiliation': 'Neurology Unit, Department of Human Neurosciences, ""Sapienza"" University, Rome, Italy.'}]",Expert review of neurotherapeutics,['10.1080/14737175.2019.1681265']
780,27471048,Long-term psychosocial outcomes of low-dose CT screening: results of the UK Lung Cancer Screening randomised controlled trial.,"BACKGROUND


The UK Lung Cancer Screening (UKLS) trial is a randomised pilot trial of low-dose CT (LDCT) screening for individuals at high risk of lung cancer. We assessed the long-term psychosocial impact on individuals participating in the UKLS trial.
METHODS


A random sample of individuals aged 50-75 years was contacted via primary care. High-risk individuals who completed T 0  questionnaires (baseline) were randomised to LDCT screening (intervention) or usual care (no screening control). T 1  questionnaires were sent 2 weeks after baseline scan results or control assignment. T 2  questionnaires were sent up to 2 years after recruitment. Measures included cancer distress, anxiety, depression and decision satisfaction.
RESULTS


A total of 4037 high-risk individuals were randomised and they completed T 0  questionnaires (n=2018 intervention, n=2019 control). Cancer distress was higher at T 1  in intervention arm participants who received positive screening results (p≤0.001), but not at T 2  (p=0.04). T 2  anxiety (p≤0.001) and depression (p≤0.01) were higher in the control arm, but the absolute differences were small and not clinically relevant. At both time points, fewer control than screened participants were satisfied with their decision to participate in UKLS (p≤0.001). Regardless of trial allocation, cancer distress was higher in women (p≤0.01), participants aged ≤65 years (p≤0.001), current smokers (p≤0.001), those with lung cancer experience (p≤0.001) and those recruited from the Liverpool area (p≤0.001).
CONCLUSION


Lung cancer screening using LDCT appears to have no clinically significant long-term psychosocial impact on high-risk participants. Strategies for engaging and supporting underserved groups are the key to implement routine lung cancer screening in the UK.
TRIAL REGISTRATION NUMBER


ISRCTN 78513845; results.",2016,"Cancer distress was higher at T 1  in intervention arm participants who received positive screening results (p≤0.001), but not at T 2  (p=0.04).","['individuals at high risk of lung cancer', 'High-risk individuals who completed T 0  questionnaires (baseline', 'women (p≤0.01), participants aged ≤65\u2005years (p≤0.001), current smokers (p≤0.001), those with lung cancer experience (p≤0.001) and those recruited from the Liverpool area (p≤0.001', 'individuals participating in the UKLS trial', 'A total of 4037 high-risk individuals', 'individuals aged 50-75\u2005years was contacted via primary care']","['low-dose CT screening', 'CT (LDCT) screening', 'LDCT screening (intervention) or usual care (no screening control', 'LDCT']","['cancer distress', 'T 2  anxiety (p≤0.001) and depression', 'cancer distress, anxiety, depression and decision satisfaction', 'Cancer distress']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",4037.0,0.335015,"Cancer distress was higher at T 1  in intervention arm participants who received positive screening results (p≤0.001), but not at T 2  (p=0.04).","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Kate J', 'Initials': 'KJ', 'LastName': 'Lifford', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burke', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McRonald', 'Affiliation': 'Public Health England, Liverpool, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hansell', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Department of Respiratory Medicine, Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Field', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}]",Thorax,['10.1136/thoraxjnl-2016-208283']
781,30887927,"Dietary Adherence, Self-Efficacy, and Health Behavior Change of WASHOKU-Modified DASH Diet: A Sub-analysis of the DASH-JUMP Study.","BACKGROUND


We previously reported the nutritional characteristics and effects of the DASH-JUMP diet, which is a WASHOKU-modified DASH diet, in Japanese participants with untreated high-normal blood pressure or stage 1 hypertension. The dietary adherence of the DASH diet in Japanese participants has never been evaluated before.
OBJECTIVE


We aimed to assess the relationships between dietary adherence, self-efficacy, and health behavior change among study participants who received the DASH-JUMP diet by home delivery.
METHODS


Participants were treated with the DASH-JUMP diet for 2 months and consumed their usual diets for the next 4 months. We conducted surveys using the stage of behavior change model questionnaire and the modified perceived health competence scale Japanese version questionnaire at baseline and 1, 2, 3, and 6 months to assess dietary adherence.
RESULTS


Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years) returned completed questionnaires, which we analyzed. Health behavior change was motivated by previous behavioral changes and improved biomarkers. The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy. The experience of the DASH-JUMP study for participants included three processes to improve lifestyle habits: Phase 1, reflecting on previous lifestyle habits; Phase 2, learning through new experiences and the acquisition of knowledge; and Phase 3, desiring to maintain their own health.
CONCLUSION


It indicated that the DASH-JUMP diet significantly increased self-efficacy and promoted health behavior change.",2020,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"['Forty-three participants (25 men, 18 women; mean age 53.6 ± 8.2 years', 'Japanese participants with untreated high-normal blood pressure or stage 1 hypertension', 'Japanese participants', 'Participants were treated with the', 'study participants who received the DASH-JUMP diet by home delivery']","['DASH-JUMP diet', 'modified DASH Diet', 'DASH diet']","['health behavior change and previous self-efficacy', 'improvement and maintenance of self-efficacy', 'health competence scale Japanese version questionnaire', 'Dietary Adherence, Self-Efficacy, and Health Behavior Change', 'self-efficacy and promoted health behavior change', 'dietary adherence, self-efficacy, and health behavior change']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}]","[{'cui': 'C0018687'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0222045'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",43.0,0.019028,The improvement and maintenance of self-efficacy were deeply related to health behavior change and previous self-efficacy.,"[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Kawamura', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Inagaki', 'Affiliation': 'Faculty of Nursing Science, Yamanashi Prefectural University, Kouhu, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Umemoto', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kajiya', 'Affiliation': 'Department of Food Science and Biotechnology, Faculty of Agriculture, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kishi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Mitarai', 'Affiliation': 'Central Research Institute, Maruha Nichiro Corporation, Tsukuba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oda', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}, {'ForeName': 'Sei', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Molecular Physiology and Medical Bioregulation, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}]",Current hypertension reviews,['10.2174/1573402115666190318125006']
782,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
783,30663156,"Changes in dietary intake, plasma carotenoids and erythrocyte membrane fatty acids in breast cancer survivors after a lifestyle intervention: results from a single-arm trial.","BACKGROUND


The influence of nutrition on breast cancer prognosis is still inconclusive and therefore dietary interventions incorporating dietary biomarkers are needed to confirm compliance with dietary goals and clarify biological mechanisms. The present study assessed whether a lifestyle intervention in breast cancer survivors could affect dietary biomarkers of fruit and vegetables and fatty acids.
METHODS


In this phase II single-arm trial, 37 overweight/obese early stage breast cancer patients completed a 12-week diet and exercise intervention. The intervention involved 1-h weekly diet sessions delivered by a dietician and 75-min bi-weekly physical activity sessions of moderate-to-high intensity led by trained monitors. Before and after the intervention, three 24-h dietary recalls were carried out to calculate nutrient intakes and, in addition, blood samples were taken to measure plasma carotenoids, vitamin E and retinol concentrations and erythrocyte membrane fatty acid (EFA) composition. Wilcoxon signed rank tests were used to assess changes in dietary and biomarkers measurements over the intervention period.
RESULTS


After the intervention, there was a significant increase in the intake of dietary carotenoids (+15.1% compared to baseline) but not plasma carotenoids levels (+6.3%). Regarding the EFA levels, we observed a significant decrease in percentage of saturated fatty acids (-1.4%) and n-6 polyunsaturated fatty acids (-2.9%) and an increase in monounsaturated fatty acids (1.7%) and total and long-chain n-3 polyunsaturated fatty acids (by 13.1% and 13.7%, respectively). A favourable decrease in the ratio of long-chain n-6 to n-3 polyunsaturated fatty acids (-9.1%) was also observed.
CONCLUSIONS


After a short-term diet and exercise intervention in overweight/obese breast cancer survivors, we observed significant changes in dietary nutrients and fatty acid biomarkers, suggesting positive dietary changes that could be relevant for breast cancer prognosis.",2019,"After the intervention, there was a significant increase in the intake of dietary carotenoids (+15.1% compared to baseline) but not plasma carotenoids levels (+6.3%).","['37 overweight/obese early stage breast cancer patients', 'overweight/obese breast cancer survivors', 'breast cancer survivors after a lifestyle intervention', 'breast cancer survivors']","['lifestyle intervention', 'short-term diet and exercise intervention', 'diet sessions delivered by a dietician and 75-min bi-weekly physical activity sessions of moderate-to-high intensity led by trained monitors', 'diet and exercise intervention']","['n-6 polyunsaturated fatty acids', 'total and long-chain n-3 polyunsaturated fatty acids', 'dietary intake, plasma carotenoids and erythrocyte membrane fatty acids', 'intake of dietary carotenoids', 'ratio of long-chain n-6 to n-3 polyunsaturated fatty acids', 'percentage of saturated fatty acids', 'monounsaturated fatty acids', 'plasma carotenoids levels', 'plasma carotenoids, vitamin E and retinol concentrations and erythrocyte membrane fatty acid (EFA) composition']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]","[{'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0007271', 'cui_str': 'Carotenes and Carotenoids'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",37.0,0.0170637,"After the intervention, there was a significant increase in the intake of dietary carotenoids (+15.1% compared to baseline) but not plasma carotenoids levels (+6.3%).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Buckland', 'Affiliation': ""Unit of Nutrition and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Travier', 'Affiliation': ""Unit Breast Cancer Screening Unit, Cancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Arribas', 'Affiliation': 'Clinical Nutrition Unit, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Del Barco', 'Affiliation': 'Department of Medical Oncology-ICO, Hospital Universitari de Girona Dr Josep Trueta, Girona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': 'Breast Cancer Unit, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zamora', 'Affiliation': ""Department of Breast Cancer Oncology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellet', 'Affiliation': ""Department of Breast Cancer Oncology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cirauqui', 'Affiliation': 'Department of Medical Oncology-ICO, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Margelí', 'Affiliation': 'Department of Medical Oncology-ICO, Hospital Germans Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Muñoz', 'Affiliation': ""Translational Genomics and Targeted Therapeutics, Institut d'Investigacions Biomèdiques Pi i Sunyer IDIBAPS, Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tusquets', 'Affiliation': 'Department of Medical Oncology, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Arcusa', 'Affiliation': 'Department of Medical Oncology, Consorci Sanitari de Terrassa, Terrassa, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Javierre', 'Affiliation': 'Department of Physiological Sciences II, School of Medicine, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Moreno', 'Affiliation': 'Breast Cancer Unit, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, Spain.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Valverde', 'Affiliation': 'Breast Cancer Unit, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'Centre for Health Protection, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Chajès', 'Affiliation': 'Nutrition and Metabolism Department, International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Castro', 'Affiliation': ""Unit of Nutrition and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Agudo', 'Affiliation': ""Unit of Nutrition and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12621']
784,31683021,Efficacy of Interpretation Bias Modification in Patients With Chronic Pain.,"Patients with chronic pain demonstrate interpretational bias to pain, and models of pain suggest interpretational bias affects subsequent pain experience. This study developed an interpretation bias modification for pain (IBM-P) and examined its efficacy. A total of 48 patients with chronic pain were recruited and randomly assigned to either the training group (n = 24) or the control group (n = 24). Interpretational bias, negative emotions, and attentional bias to pain-related stimuli were assessed before and after conducting IBM-P. The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group. The training group also gazed at neutral words longer than at ""new"" affective pain words after IBM-P than they did prior to the intervention. Furthermore, significant mediating effects of postinterpretational bias were found in the relationship between the group type and postnegative emotions and postdwell time bias. These results suggest that IBM-P can modify interpretational bias which leads to changes in negative emotions and attentional bias. Future research is needed to confirm the effect of modifying interpretational bias and its clinical utility in the field of pain management. PERSPECTIVE: This article investigated the efficacy of IBM-P and suggested that modifying interpretational bias is followed by changes in negative emotions and attentional bias. These findings may help health professionals understand the role of interpretational bias in chronic pain and encourage the potential use of IBM in pain management.",2020,The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group.,"['48 patients with chronic pain', 'Patients with Chronic Pain', 'Patients with chronic pain']",['Interpretation Bias Modification'],"['negative emotions and attentional bias', 'Interpretational bias, negative emotions, and attentional bias to pain-related stimuli', 'interpretational bias and negative emotions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",48.0,0.0286894,The main results indicated that the training group showed less interpretational bias and negative emotions after IBM-P than the control group.,"[{'ForeName': 'Jeongwi', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Kyeong-Seok', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'Hearim Medical Clinic, Daejeon, Republic of Korea.'}, {'ForeName': 'Youn-Hee', 'Initials': 'YH', 'LastName': 'Jung', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Sungkun', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Psychology, Chungnam National University, Daejeon, Republic of Korea. Electronic address: sungkunc@cnu.ac.kr.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.10.005']
785,30653416,Remote ischemic preconditioning increases accumulated oxygen deficit in middle-distance runners.,"The mediators underlying the putative benefits of remote ischemic preconditioning (IPC) on dynamic whole body exercise performance have not been widely investigated. Our objective was to test the hypothesis that remote IPC improves supramaximal exercise performance in National Collegiate Athletic Association (NCAA) Division I middle-distance runners by increasing accumulated oxygen deficit (AOD), an indicator of glycolytic capacity. A randomized sham-controlled crossover study was employed. Ten NCAA Division I middle-distance athletes [age: 21 ± 1 yr; maximal oxygen uptake (V̇o 2max ): 65 ± 7 ml·kg -1 ·min -1 ] completed three supramaximal running trials (baseline, after mock IPC, and with remote IPC) at 110% V̇o 2max  to exhaustion. Remote IPC was induced in the right arm with 4 × 5 min cycles of brachial artery ischemia with 5 min of reperfusion. Supramaximal AOD (ml/kg) was calculated as the difference between the theoretical oxygen demand required for the supramaximal running bout (linear regression extrapolated from ~12 × 5 min submaximal running stages) and the actual oxygen demand for these bouts. Remote IPC [122 ± 38 s, 95% confidence interval (CI): 94-150] increased ( P  < 0.001) time to exhaustion 22% compared with baseline (99 ± 23 s, 95% CI: 82-116,  P  = 0.014) and sham (101 ± 30 s, 95% CI: 80-123,  P  = 0.001). In the presence of IPC, AOD was 47 ± 36 ml/kg (95% CI: 20.8-73.9), a 29% increase compared with baseline (36 ± 28 ml/kg, 95% CI: 16.3-56.9,  P  = 0.008) and sham (38 ± 32 ml/kg, 95% CI: 16.2-63.0,  P  = 0.024). Remote IPC considerably improved supramaximal exercise performance in NCAA Division I middle-distance athletes. Greater glycolytic capacity, as estimated by increased AOD, is a potential mediator for these performance improvements.  NEW & NOTEWORTHY  Our novel findings indicate that ischemic preconditioning enhanced glycolytic exercise capacity, enabling National Collegiate Athletic Association (NCAA) middle-distance track athletes to run ~22 s longer before exhaustion compared with baseline and mock ischemic preconditioning. The increase in ""all-out"" performance appears to be due to increased accumulated oxygen deficit, an index of better supramaximal capacity. Of note, enhanced exercise performance was demonstrated in a specific group of in-competition NCAA elite athletes that has already undergone substantial training of the glycolytic energy systems.",2019,Remote IPC considerably improved supramaximal exercise performance in NCAA Division,"['National Collegiate Athletic Association (NCAA', 'middle-distance runners', 'NCAA Division', 'I middle-distance athletes', 'I middle-distance athletes [age: 21\u2009±\u20091 yr']","['maximal oxygen uptake (V̇o 2max ): 65\u2009±\u20097 ml·kg -1 ·min -1 ] completed three supramaximal running trials (baseline, after mock IPC, and with remote IPC', 'remote ischemic preconditioning (IPC', 'Remote ischemic preconditioning', 'Division']","['accumulated oxygen deficit (AOD', 'Greater glycolytic capacity', 'glycolytic exercise capacity, enabling National Collegiate Athletic Association (NCAA) middle-distance track athletes', 'supramaximal exercise performance', 'oxygen deficit']","[{'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C1293097', 'cui_str': 'Division - action (qualifier value)'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",,0.563839,Remote IPC considerably improved supramaximal exercise performance in NCAA Division,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Paull', 'Affiliation': 'Vascular Protection Research Laboratory, Department of Health and Nutritional Sciences, South Dakota State University , Brookings, South Dakota.'}, {'ForeName': 'Gary P', 'Initials': 'GP', 'LastName': 'Van Guilder', 'Affiliation': 'Vascular Protection Research Laboratory, Department of Health and Nutritional Sciences, South Dakota State University , Brookings, South Dakota.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00585.2018']
786,30418198,Effectiveness of Field-Based Resistance Training Protocols on Hip Muscle Strength Among Young Elite Football Players.,"OBJECTIVE


The objective of this study was to examine the effects of an 8-week progressive resistance training program on hip joint muscles' strength measures, using the Copenhagen adduction (CA) and the sliding hip (SH) exercises.
DESIGN


Prospective randomized controlled trial.
SETTING


Sport training and medical centers.
PARTICIPANTS


Forty-two young male football athletes (age 17.5 ± 1.1 years; height 178.3 ± 3.2 cm; body mass 66.1 ± 8.6 kg) allocated to a CA, SH, and matched control (C) group.
INTERVENTIONS


Two weekly sessions of CA and SH.
MAIN OUTCOME MEASURES


Maximal eccentric strength test for the hip adductor (EHAD) and maximal eccentric strength test for the hip abductor (EHAB) muscles, and the relative EHAD/EHAB ratio assessed through a break test in the side-lying position.
RESULTS


No significant differences between groups were found at baseline for any of the assessed variables (all P > 0.053). The CA group had a significant strength increase in the right and left leg (d = 2.11, d = 1.9, respectively). The SH group also had a significant strength increase in the right and left leg (d = 1.68 and d = 1.67, respectively). The CA group presented EHAD/EHAB improvements in the right and left leg (d = 0.84 and d = 1.14, respectively). The SH group also presented EHAD/EHAB improvements in the right and left leg (d = 1.34 and d = 1.44, respectively).
CONCLUSIONS


Both exercises' protocols were effective in inducing significant increases on EHAD, EHAB, and EHAD/EHAB ratio when compared with the control group. Practitioners should be aware of the training effectiveness of both protocols.",2020,No significant differences between groups were found at baseline for any of the assessed variables (all P > 0.053).,"['Forty-two young male football athletes (age 17.5 ± 1.1 years; height 178.3 ± 3.2 cm; body mass 66.1 ± 8.6 kg) allocated to a CA, SH, and matched control (C) group', 'Young Elite Football Players', 'Sport training and medical centers']","['Copenhagen adduction (CA) and the sliding hip (SH) exercises', 'progressive resistance training program', 'Field-Based Resistance Training Protocols']","['right and left leg', 'Maximal eccentric strength test for the hip adductor (EHAD) and maximal eccentric strength test for the hip abductor (EHAB) muscles, and the relative EHAD/EHAB ratio assessed through a break test in the side-lying position', 'Hip Muscle Strength', 'EHAD, EHAB, and EHAD/EHAB ratio']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0231457', 'cui_str': 'Adduction, function (observable entity)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0454362', 'cui_str': 'Hip exercises (regime/therapy)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position (finding)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",42.0,0.0128678,No significant differences between groups were found at baseline for any of the assessed variables (all P > 0.053).,"[{'ForeName': 'Bar', 'Initials': 'B', 'LastName': 'Kohavi', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, UCAM, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Beato', 'Affiliation': 'School of Science, Technology and Engineering, University of Suffolk, Ipswich, United Kingdom.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Laver', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Tomas T', 'Initials': 'TT', 'LastName': 'Freitas', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, UCAM, Spain.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Chung', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, UCAM, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': 'Life Sciences Department, The Academic College at Wingate, Natanya, Israel.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000649']
787,30518302,Sumter County on the Move! Evaluation of a Walking Group Intervention to Promote Physical Activity Within Existing Social Networks.,"BACKGROUND


Social network-driven approaches have promise for promoting physical activity in community settings. Yet, there have been few direct investigations of such interventions. This study tested the effectiveness of a social network-driven, group-based walking intervention in a medically underserved community.
METHODS


This study used a quasi-experimental pretest-posttest design with 3 measurement time points to examine the effectiveness of Sumter County on the Move! in communities in Sumter County, SC. A total of 293 individuals participated in 59 walking groups formed from existing social networks. Participants were 86% females, 67% black, and 31% white, with a mean age of 49.5 years. Measures included perceptions of the walking groups; psychosocial factors such as self-regulation, self-efficacy, and social support; and both self-reported and objectively measured physical activity.
RESULTS


The intervention produced significant increases in goal setting and social support for physical activity from multiple sources, and these intervention effects were sustained through the final measurement point 6 months after completion of the intervention. Nonetheless, few of the desired changes in physical activity were observed.
CONCLUSION


Our mixed results underscore the importance of future research to better understand the dose and duration of intervention implementation required to effect and sustain behavior change.",2018,"The intervention produced significant increases in goal setting and social support for physical activity from multiple sources, and these intervention effects were sustained through the final measurement point 6 months after completion of the intervention.","['Participants were 86% females, 67% black, and 31% white, with a mean age of 49.5 years', 'medically underserved community', '293 individuals participated in 59 walking groups formed from existing social networks']","['Walking Group Intervention', 'social network-driven, group-based walking intervention']","['physical activity', 'perceptions of the walking groups; psychosocial factors such as self-regulation, self-efficacy, and social support; and both self-reported and objectively measured physical activity', 'goal setting and social support for physical activity', 'Physical Activity']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}]",293.0,0.0147345,"The intervention produced significant increases in goal setting and social support for physical activity from multiple sources, and these intervention effects were sustained through the final measurement point 6 months after completion of the intervention.","[{'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Forthofer', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wilcox', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kinnard', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Hutto', 'Affiliation': ''}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Sharpe', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2017-0603']
788,30282699,Impact of Gastric Banding Versus Metformin on β-Cell Function in Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes.,"OBJECTIVE


Type 2 diabetes (T2D) results from progressive loss of β-cell function. The BetaFat study compared gastric banding and metformin for their impact on β-cell function in adults with moderate obesity and impaired glucose tolerance (IGT) or recently diagnosed, mild T2D.
RESEARCH DESIGN AND METHODS


Eighty-eight people aged 21-65 years, BMI 30-40 kg/m 2 , with IGT or diabetes known for <1 year, were randomized to gastric banding or metformin for 2 years. Hyperglycemic clamps (11.1 mmol/L) followed by arginine injection at maximally potentiating glycemia (>25 mmol/L) were performed at baseline, 12 months, and 24 months to measure steady-state C-peptide (SSCP) and acute C-peptide response to arginine at maximum glycemic potentiation (ACPRmax) and insulin sensitivity (M/I).
RESULTS


At 24 months, the band group lost 10.7 kg; the metformin group lost 1.7 kg ( P  < 0.01). Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups). SSCP adjusted for insulin sensitivity fell slightly but not significantly in each group ( P  = 0.34 between groups). ACPRmax adjusted for insulin sensitivity fell significantly in the metformin group ( P  = 0.002) but not in the band group ( P  = 0.25 between groups). HbA 1c  fell at 12 and 24 months in the band group ( P  < 0.004) but only at 12 months ( P  < 0.01) in the metformin group ( P  > 0.14 between groups). Normoglycemia was present in 22% and 15% of band and metformin groups, respectively, at 24 months ( P  = 0.66 between groups).
CONCLUSIONS


Gastric banding and metformin had similar effects to preserve β-cell function and stabilize or improve glycemia over a 2-year period in moderately obese adults with IGT or recently diagnosed, mild T2D.",2018,Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups).,"['moderately obese adults with IGT or recently diagnosed, mild T2D', 'adults with moderate obesity and impaired glucose tolerance (IGT) or recently diagnosed, mild T2D', 'Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes', 'Eighty-eight people aged 21-65 years, BMI 30-40 kg/m 2 , with IGT or diabetes known for <1 year']","['metformin', 'Gastric Banding Versus Metformin', 'Gastric banding and metformin', 'Hyperglycemic clamps', 'gastric banding or metformin', 'gastric banding and metformin']","['steady-state C-peptide (SSCP) and acute C-peptide response to arginine at maximum glycemic potentiation (ACPRmax) and insulin sensitivity (M/I', 'β-cell function', 'HbA 1c  fell', 'SSCP adjusted for insulin sensitivity fell', 'ACPRmax adjusted for insulin sensitivity fell', 'Normoglycemia', 'β-Cell Function', 'Insulin sensitivity', 'β-cell function and stabilize or improve glycemia']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3854330', 'cui_str': 'Gastric band (physical object)'}, {'cui': 'C1960832', 'cui_str': 'Partitioning of stomach using band (procedure)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0243031', 'cui_str': 'SSCP'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",88.0,0.0382476,Insulin sensitivity increased 45% in the band group and 25% in the metformin group ( P  = 0.30 between groups).,"[{'ForeName': 'Anny H', 'Initials': 'AH', 'LastName': 'Xiang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA buchanan@usc.edu anny.h.xiang@kp.org.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Trigo', 'Affiliation': 'Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Martinez', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Namir', 'Initials': 'N', 'LastName': 'Katkhouda', 'Affiliation': 'Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Beale', 'Affiliation': 'Division of Endocrinology and Diabetes, Department of Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Chow', 'Affiliation': 'Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, CA.'}, {'ForeName': 'Cortney', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Krishna S', 'Initials': 'KS', 'LastName': 'Nayak', 'Affiliation': 'Ming Hsieh Department of Electrical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Hendee', 'Affiliation': 'Division of Endocrinology, Clinical Nutrition and Metabolism, Department of Internal Medicine, University of Nevada Reno School of Medicine, Reno, NV.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc18-1662']
789,30208868,What makes the pregnant women revisit public hospitals for research? Participant engagement and retention trial in a public hospital (PERTH): an RCT protocol.,"BACKGROUND


Cohort studies have public health importance as they effectively provide evidence on determinants of health from a life course perspective. Researchers often confront the poor follow-up rates as a major challenge in the successful conduct of cohort studies. We are currently recruiting in a birth cohort study, titled as ""Maternal Antecedents of Adiposity and Studying the Transgenerational role of Hyperglycemia and Insulin"" (MAASTHI) in a public hospital; with the aim of assessing maternal glycemic levels on the risk of adverse fetal outcomes. Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital.
METHODS


A randomized trial of 795 pregnant women, with 265 women each in three arms observed through pregnancy, until their baby is 14 weeks old. The comparator group receives a standard leaflet, with details on the importance of glucose testing and regular follow up in pregnancy. Intervention arm-1 will receive the standard leaflet plus individualized messages, through an Interactive Voice Response (IVR) system; a type of computer-linked telephone intervention system to remind the participants about the lab test and follow-up dates. Intervention arm- 2 will have the opportunity to attend Mother and Baby Affairs (MBA) workshops, which will provide information on Gestational Diabetes Mellitus (GDM) screening and management to pregnant women and personalized counselling services. The outcome of interest is the difference in the proportion of participants completing follow-up at different points in time, among three arms.
DISCUSSION


Between the two interventions (IVR and MBA), the study results would uncover the contextually specific, timely intervention, which can increase the proportion of pregnant women followed up in public hospitals. If effective, this study will provide information on an effective intervention, useful in ensuring the success of longitudinal follow-up in the public hospitals.
TRIAL REGISTRATION


NCT03088501 , Date Registered: 16/03/2017.",2018,"Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital.
","['pregnant women revisit public hospitals', '795 pregnant women, with 265 women each in three arms observed through pregnancy, until their baby is 14\xa0weeks old']","['two interventions (IVR and MBA', 'Interactive Voice Response (IVR) system; a type of computer-linked telephone intervention system']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]",[],795.0,0.0816367,"Nested within the ongoing cohort, the proposed trial aims to evaluate the effectiveness of two interventions in improving the follow-up in the cohort study in a public hospital.
","[{'ForeName': 'Giridhara R', 'Initials': 'GR', 'LastName': 'Babu', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India. giridhar@iiphh.org.'}, {'ForeName': 'Maithili', 'Initials': 'M', 'LastName': 'Karthik', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Ravi', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India.'}, {'ForeName': 'Yamuna', 'Initials': 'Y', 'LastName': 'Ana', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India.'}, {'ForeName': 'Prafulla', 'Initials': 'P', 'LastName': 'Shriyan', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India.'}, {'ForeName': 'Kiran Kumar', 'Initials': 'KK', 'LastName': 'Hasige', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India.'}, {'ForeName': 'Keerti', 'Initials': 'K', 'LastName': 'Deshpande', 'Affiliation': 'Public Health Foundation of India (PHFI), IIPH-H, Bengaluru campus, SIHFW premises, Beside leprosy hospital, 1st cross, Magadi road, Bengaluru, 560023, India.'}, {'ForeName': 'Lokesh Bangalore', 'Initials': 'LB', 'LastName': 'Siddlingaiah', 'Affiliation': 'Jayanagar General Hospital, Bengaluru, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'London School of Hygiene & Tropical Medicine & University College London Hospital, London, UK.'}, {'ForeName': 'Gudlavalleti Venkata Satyanarayana', 'Initials': 'GVS', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health-Hyderabad, Plot # 1, A.N.V.Arcade, Amar Co-op Society, Kavuri Hills, Madhapur, Hyderabad, 500033, India.'}]",BMC pregnancy and childbirth,['10.1186/s12884-018-2000-1']
790,30621460,A qualitative analysis of pressure injury development among medically underserved adults with spinal cord injury.,"Purpose:  Medically underserved adults with spinal cord injury (SCI) remain at high risk of incurring medically serious pressure injuries even after receiving education in prevention techniques. The purpose of this research is to identify circumstances leading to medically serious pressure injury development in medically underserved adults with SCI during a lifestyle-based pressure injury prevention program, and provide recommendations for future rehabilitation approaches and intervention design. Methods:  This study entailed a qualitative secondary case analysis of treatment notes from a randomized controlled trial. Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT. Results and conclusions:  Among the 25 participants, 40 unique medically serious pressure injuries were detected. The six themes related to medically serious pressure injury development were: (1)  lack of rudimentary knowledge pertaining to wound care ; (2)  equipment and supply issues ; (3)  comorbidities ; (4)  non-adherence to prescribed bed rest ; (5)  inactivity ; and (6)  circumstances beyond the intervention's reach.  Together, these factors may have undermined the effectiveness of the intervention program. Modifications, such as assessing health literacy levels of patients prior to providing care, providing tailored wound care education, and focusing on equipment needs, have potential for altering future rehabilitation programs and improving health outcomes.Implications for rehabilitationTo provide patients with spinal cord injury with the necessary information to prevent medically serious pressure injury development, health care providers need to understand their patient's unique personal contexts, including socio-economic status, language skills, and mental/cognitive functioning.When providing wound care information to patients with spinal cord injury who have developed a medically serious pressure injury, practitioners should take into account the level of health literacy of their patient in order to provide education that is appropriate and understandable.Practitioners should be aware of how to help their patient advocate for outside services and care that address their equipment needs, such as finding funding or grants to pay for expensive medical equipment.",2020,The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach.,"['patients with spinal cord injury', 'medically underserved adults with spinal cord injury', 'Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT', '25 participants, 40 unique medically serious pressure injuries', 'patients with spinal cord injury who have developed a medically serious pressure injury, practitioners', 'medically underserved adults with SCI during a lifestyle-based pressure injury prevention program', 'Medically underserved adults with spinal cord injury (SCI']",[],"[""medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0332679', 'cui_str': 'Pressure injury'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0014674', 'cui_str': 'Apparatus and Instruments'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",40.0,0.0512108,The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention's reach.,"[{'ForeName': 'Lucía I', 'Initials': 'LI', 'LastName': 'Floríndez', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Mike E', 'Initials': 'ME', 'LastName': 'Carlson', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pyatak', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Cogan', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alix G', 'Initials': 'AG', 'LastName': 'Sleight', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hill', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Erna', 'Initials': 'E', 'LastName': 'Blanche', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Garber', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Florence A', 'Initials': 'FA', 'LastName': 'Clark', 'Affiliation': 'USC Mrs. T.H. Chan Division of Occupational Science and Occupational Therapy in the Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA, USA.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1552328']
791,31313123,A simple risk score for prediction of sepsis associated-acute kidney injury in critically ill patients.,"BACKGROUND


Sepsis is common and frequently fatal condition in critically ill patients and is a major cause of acute kidney injury (AKI). In this retrospective study, we sought to develop a comprehensive risk score model of sepsis associated-AKI (SA-AKI).
METHODS


A total of 2617 patients were randomly assigned to a development (1554 patients) and a validation group (777 patients). The risk score model for SA-AKI was developed with multivariate regression analysis in development group and the model was further evaluated on validation group.
RESULTS


We identified 16 independent predictors of SA-AKI in development group (age ≥ 60 years, hypertension/coronary heart disease, diabetes, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, acute severe pancreatitis, hypotension, hypoproteinemia, lactic acidosis, the length of stay in intensive care unit(ICU), 60 g/L<hemoglobin < 90 g/L, hemoglobin ≤ 60 g/L, and ≥ 2 failed organs. This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
CONCLUSION


The novel risk score model for SA-AKI in ICU can identify patients at high risk to develop AKI. Application of this model could help clinicians to stratify patients for primary prevention, surveillance and early therapeutic intervention to improve care and prognosis of sepsis patients in ICU.",2019,"This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
","['60\xa0years, hypertension/coronary heart disease, diabetes, chronic kidney disease, heart failure, chronic obstructive pulmonary disease, acute severe pancreatitis, hypotension, hypoproteinemia, lactic acidosis, the length of stay in intensive care unit(ICU), 60\xa0g/L<hemoglobin\u2009<\u200990\xa0g/L, hemoglobin', 'sepsis patients in ICU', '2617 patients were randomly assigned to a development (1554 patients) and a validation group (777 patients', 'critically ill patients']",[],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0020639', 'cui_str': 'Hypoproteinemia'}, {'cui': 'C1869036', 'cui_str': 'Lactic acidosis (SMQ)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}]",[],[],2617.0,0.0635966,"This model had excellent performance characteristics in validation cohort(c statistic 0.857, 95% CI 0.839-0.874).
","[{'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Division of Ultrasound, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Division of Nephrology, Nanchong Central Hospital, Nanchong, 637000, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China.'}, {'ForeName': 'Dingming', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Division of Ultrasound, West China Hospital of Sichuan University, Chengdu, 610041, China. doccai@163.com.'}, {'ForeName': 'Lichuan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Division of Nephrology, West China Hospital of Sichuan University, Chengdu, 610041, China. ylcgh@163.com.'}]",Journal of nephrology,['10.1007/s40620-019-00625-y']
792,30622317,Nebivolol reduces short-term blood pressure variability more potently than irbesartan in patients with intradialytic hypertension.,"Increased blood pressure (BP) variability (BPV) is associated with high cardiovascular risk in hemodialysis. Studies on the effects of antihypertensive drugs on BPV in hemodialysis are scarce. This study examines the effects of nebivolol and irbesartan on short-term BPV in patients with intradialytic hypertension. This randomized-cross-over study included 38 patients (age: 60.4 ± 11.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase ≥ 10 mmHg at ≥4 over 6 consecutive sessions). After the baseline evaluation, participants were randomized to nebivolol 5 mg and subsequently irbesartan 150 mg, or vice versa, with a two-week wash-out period before initiation of the second drug. Patients underwent three respective 24 h-ABPM sessions starting before a midweek-session. We calculated the standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas. The post-hemodialysis and 24 h-SBP and DBP levels were significantly lower after treatment with both drugs. The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively). The diastolic-BPV indices decreased with nebivolol and increased with irbesartan, resulting in significant differences between the two drugs (SD: baseline 10.56 ± 2.50; nebivolol 9.75 ± 2.12; irbesartan 10.84 ± 1.98, between-drug p = 0.014; wSD: baseline 9.86 ± 2.12; nebivolol 9.34 ± 2.01; irbesartan 10.25 ± 2.01, between-drug p = 0.029). The diastolic-BPV during intradialytic and day-time periods was marginally lower with nebivolol than with irbesartan. During nighttime, the BPV indices were unchanged with either drug. The short-term BPV was reduced after nebivolol but not after irbesartan treatment in patients with intradialytic hypertension. These findings suggest that sympathetic-overdrive may be a major factor that affects BPV in intradialytic hypertension patients.",2019,"The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively).","['38 patients (age: 60.4\u2009±\u200911.1 years, male: 65.8%) with intradialytic hypertension (intradialytic-SBP increase\u2009≥\u200910\u2009mmHg at ≥4 over 6 consecutive sessions', 'intradialytic hypertension patients', 'patients with intradialytic hypertension']","['Nebivolol', 'nebivolol', 'nebivolol and irbesartan', 'nebivolol 5\u2009mg and subsequently irbesartan 150\u2009mg, or vice versa']","['blood pressure (BP) variability (BPV', 'diastolic-BPV indices', 'BPV indices', 'SBP and DBP levels', 'short-term BPV', 'diastolic-BPV during intradialytic and day-time periods', 'standard deviation (SD), weighted SD (wSD), coefficient of variation (CV), and average real variability (ARV) of BP with validated formulas', 'systolic-BPV indices']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}]","[{'cui': 'C0068475', 'cui_str': 'nebivolol'}, {'cui': 'C0288171', 'cui_str': 'irbesartan'}, {'cui': 'C1306211', 'cui_str': 'nebivolol 5 MG'}, {'cui': 'C0986849', 'cui_str': 'irbesartan 150 MG'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1948053', 'cui_str': 'Time periods (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",38.0,0.0273608,"The systolic-BPV indices were marginally lower after nebivolol but not after irbesartan compared to baseline (SD: baseline 15.70 ± 4.69; nebivolol 14.45 ± 3.37, p = 0.090; irbesartan 15.39 ± 3.85, p = 0.706; wSD: 14.62 ± 4.36 vs 13.40 ± 3.07, p = 0.053 vs 14.36 ± 3.47, p = 0.805, respectively).","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Bikos', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Raptis', 'Affiliation': 'Pieria Hemodialysis Unit, Katerini, Greece.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Afkou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrgidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stylianos', 'Initials': 'S', 'LastName': 'Panagoutsos', 'Affiliation': 'Department of Nephrology, General Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Ploumis', 'Initials': 'P', 'LastName': 'Pasadakis', 'Affiliation': 'Department of Nephrology, General Hospital of Alexandroupolis, Alexandroupolis, Greece.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Balaskas', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Liakopoulos', 'Affiliation': 'Section of Nephrology and Hypertension, 1st Department of Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'Istituto Auxologico Italiano, IRCCS, Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, Milan, Italy.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. psarafidis11@yahoo.gr.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0194-2']
793,25830446,"The RAISE early treatment program for first-episode psychosis: background, rationale, and study design.","OBJECTIVE


The premise of the National Institute of Mental Health Recovery After an Initial Schizophrenia Episode Early Treatment Program (RAISE-ETP) is to combine state-of-the-art pharmacologic and psychosocial treatments delivered by a well-trained, multidisciplinary team in order to significantly improve the functional outcome and quality of life for first-episode psychosis patients. The study is being conducted in non-academic (ie, real-world) treatment settings, using primarily extant reimbursement mechanisms.
METHOD


We developed a treatment model and training program based on extensive literature review and expert consultation. Our primary aim is to compare the experimental intervention to ""usual care"" on quality of life. Secondary aims include comparisons on remission, recovery, and cost-effectiveness. Patients 15-40 years old with a first episode of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or brief psychotic disorder according to DSM-IV and no more than 6 months of treatment with antipsychotic medications were eligible. Patients are followed for a minimum of 2 years, with major assessments conducted by blinded, centralized raters using live, 2-way video. We selected 34 clinical sites in 21 states and utilized cluster randomization to assign 17 sites to the experimental treatment and 17 to usual care. Enrollment began in July 2010 and ended in July 2012 with 404 subjects. The results of the trial will be published separately. The goal of the article is to present both the overall development of the intervention and the design of the clinical trial to evaluate its effectiveness.
CONCLUSIONS


We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT01321177.",2015,"We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia.
","['34 clinical sites in 21 states and utilized cluster randomization to assign 17 sites to the experimental treatment and 17 to usual care', 'Enrollment began in July 2010 and ended in July 2012 with 404 subjects', 'Patients 15-40 years old with a first episode of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified, or brief psychotic disorder according to DSM-IV and no more than 6 months of treatment with antipsychotic medications were eligible']",[],"['remission, recovery, and cost-effectiveness', 'functional outcome and quality of life', 'quality of life']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0036358', 'cui_str': 'Schizophreniform Disorders'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0033958', 'cui_str': 'Psychosis, Brief Reactive'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}]",[],"[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}]",,0.0516895,"We believe that we have succeeded in both designing a multimodal treatment intervention that can be delivered in real-world clinical settings and implementing a controlled clinical trial that can provide the necessary outcome data to determine its impact on the trajectory of early phase schizophrenia.
","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Department of Psychiatry, The Zucker Hillside Hospital, 75-59 263rd St, Kaufmann Bldg, Ste 103, Glen Oaks, NY 11004 psychiatry@lij.edu.'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Schooler', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marcy', 'Affiliation': ''}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': ''}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Brunette', 'Affiliation': ''}, {'ForeName': 'Kim T', 'Initials': 'KT', 'LastName': 'Mueser', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rosenheck', 'Affiliation': ''}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Addington', 'Affiliation': ''}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Estroff', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Penn', 'Affiliation': ''}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.14m09289']
794,31672070,Nurse-Delivered Brief Behavioral Treatment for Insomnia in Lung Cancer Survivors: A Pilot RCT.,"Objective/Background : Insomnia occurs in 50 to 80% of lung cancer survivors. Cognitive behavioral therapy is the standard treatment for insomnia (CBTI); however, treatment length and lack of psychologists trained in CBTI limits access. Brief Behavioral Treatment for Insomnia (BBTI), a nurse-delivered modified CBTI, is proposed. This feasibility pilot study sought to compare the BBTI intervention to attention control Healthy Eating Program (HEP) for insomnia in lung cancer survivors.  Participants : The participants comprised adults, 21 years of age or older with insomnia and stage I/II non-small cell lung cancer, more than 6 weeks from surgery and living in Western NY.  Methods : Participants (n = 40) were randomly assigned to an experimental (BBTI) or attention control condition (Healthy Eating Program). Thirty participants completed the study.  Results : Participants were 66 years of age (± 7.6; range 53-82), 40% (n = 16) male, 87.5% (n = 35) Caucasian, 50% (n = 20) married, BMI 27.7 (± 5.8), and 12% (n = 5) never smokers. Baseline sleep diary sleep efficiency, ISI and other baseline covariates were balanced between the groups. Sleep efficiency improved ≥85% in BBTI group ( p  = .02), but not in HEP control group ( p  = 1.00). Mean ISI for BBTI and attention control were 6.40 ± 4.98 and 14.10 ± 4.48 ( p  = .001) respectively. In addition, BBTI group mean total FACT-L score improved by 6.66 points from baseline while HEP group score worsened ( p  = .049).  Conclusions : BBTI is a practical, evidence-based, clinically relevant intervention that improved sleep and quality of life in lung cancer survivors with insomnia. Additional research to evaluate efficacy, duration, and implementation strategies are essential.",2020,"Sleep efficiency improved ≥85% in BBTI group ( p  = .02), but not in HEP control group ( p  = 1.00).","['Participants were 66\xa0years of age (± 7.6; range 53-82), 40% (n\xa0=\xa016) male, 87.5% (n\xa0=\xa035', 'lung cancer survivors with insomnia', 'participants comprised adults, 21\xa0years of age or older with insomnia and stage I/II non-small cell lung cancer, more than 6\xa0weeks from surgery and living in Western NY', 'Participants ', 'Thirty participants completed the study', 'Caucasian, 50% (n\xa0=\xa020) married, BMI 27.7 (± 5.8), and 12% (n\xa0=\xa05) never smokers', 'Lung Cancer Survivors', 'lung cancer survivors', 'Methods : Participants (n\xa0=\xa040']","['Cognitive behavioral therapy', 'BBTI intervention to attention control Healthy Eating Program (HEP', 'Nurse-Delivered Brief Behavioral Treatment', 'experimental (BBTI) or attention control condition (Healthy Eating Program', ' ']","['sleep and quality of life', 'Baseline sleep diary sleep efficiency, ISI and other baseline covariates', 'mean total FACT-L score', 'Sleep efficiency', 'Insomnia', 'Mean ISI for BBTI and attention control']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",30.0,0.0998049,"Sleep efficiency improved ≥85% in BBTI group ( p  = .02), but not in HEP control group ( p  = 1.00).","[{'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Dean', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Carleara', 'Initials': 'C', 'LastName': 'Weiss', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Carla R', 'Initials': 'CR', 'LastName': 'Jungquist', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Klimpt', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Alameri', 'Affiliation': 'Department of Fundamental Nursing, College Nursing, Imam Abdulrahman Bin Faisal University , Dammam, Saudi Arabia.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Ziegler', 'Affiliation': 'Department of Medicine, VA Western New York Health Systems , Buffalo, New York.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Steinbrenner', 'Affiliation': 'Department of Medicine, VA Western New York Health Systems , Buffalo, New York.'}, {'ForeName': 'Elisabeth U', 'Initials': 'EU', 'LastName': 'Dexter', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine , Buffalo, New York.'}, {'ForeName': 'Samjot S', 'Initials': 'SS', 'LastName': 'Dhillon', 'Affiliation': 'Department of Medicine, Jacobs School of Medicine , Buffalo, New York.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Lucke', 'Affiliation': 'Department of Psychiatry, Clinical and Research Institute on Addictions , Buffalo, New York.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Dickerson', 'Affiliation': 'School of Nursing, University at Buffalo, State University of New York , Buffalo, New York.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1685523']
795,28786012,The Effects of Synbiotic Supplementation on Pregnancy Outcomes in Gestational Diabetes.,"Synbiotics are known to exert multiple beneficial effects, including anti-inflammatory and antioxidative actions. This study was designed to evaluate the effects of synbiotic administration on biomarkers of inflammation, oxidative stress, and pregnancy outcomes among gestational diabetic (GDM) women. This randomized, double-blind, placebo-controlled clinical trial was carried out among 60 subjects with GDM who were not on oral hypoglycemic agents. Patients were randomly assigned to consume either one synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), L. casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 10 9  CFU/g each) plus 800 mg inulin (HPX) (n = 30) or placebo (n = 30) for 6 weeks. Compared with the placebo, synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 4.2 vs. +1.1 ± 3.5 mg/L, P = 0.004), plasma malondialdehyde (MDA) (- 0.1 ± 0.6 vs. + 0.3 ± 0.7 μmol/L, P = 0.02), and significantly increased total antioxidant capacity (TAC) (+ 70.1 ± 130.9 vs. - 19.7 ± 124.6 mmol/L, P = 0.009) and total glutathione (GSH) levels (+ 28.7 ± 61.5 vs. - 14.9 ± 85.3 μmol/L, P = 0.02). Supplementation with synbiotic had a significant decrease in cesarean section rate (16.7 vs. 40.0%, P = 0.04), lower incidence of hyperbilirubinemic newborns (3.3 vs. 30.0%, P = 0.006), and newborns' hospitalization (3.3 vs. 30.0%, P = 0.006) compared with the placebo. Synbiotic supplementation did not affect plasma nitric oxide (NO) levels and other pregnancy outcomes. Overall, synbiotic supplementation among GDM women for 6 weeks had beneficial effects on serum hs-CRP, plasma TAC, GSH, and MDA; cesarean section; incidence of newborn's hyperbilirubinemia; and newborns' hospitalization but did not affect plasma NO levels and other pregnancy outcomes. http://www.irct.ir : www.irct.ir : IRCT201704205623N108.",2018,"Compared with the placebo, synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP)","['60 subjects with GDM who were not on oral hypoglycemic agents', 'Gestational Diabetes', 'gestational diabetic (GDM) women']","['placebo', 'Synbiotic supplementation', 'Synbiotic Supplementation', 'synbiotic', 'synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), L. casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2\xa0×\xa010 9 \xa0CFU/g each) plus 800\xa0mg inulin (HPX', 'placebo, synbiotic supplementation']","['serum high-sensitivity C-reactive protein (hs-CRP', 'Pregnancy Outcomes', 'plasma nitric oxide (NO) levels and other pregnancy outcomes', ""newborns' hospitalization"", 'total antioxidant capacity (TAC', 'hyperbilirubinemic newborns', 'biomarkers of inflammation, oxidative stress, and pregnancy outcomes', ""beneficial effects on serum hs-CRP, plasma TAC, GSH, and MDA; cesarean section; incidence of newborn's hyperbilirubinemia; and newborns' hospitalization"", 'total glutathione (GSH) levels', 'plasma malondialdehyde (MDA', 'cesarean section rate']","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0439362', 'cui_str': 'cfu/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}]",60.0,0.266331,"Compared with the placebo, synbiotic supplementation significantly decreased serum high-sensitivity C-reactive protein (hs-CRP)","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Karamali', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nabiollah', 'Initials': 'N', 'LastName': 'Nasiri', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naemeh', 'Initials': 'N', 'LastName': 'Taghavi Shavazi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Endocrinology and Metabolism Research Center, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Faculty member of Science department, science faculty, Islamic Azad University, Tehran Central branch, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-017-9313-7']
796,30590425,"Clinical outcomes, edoxaban concentration, and anti-factor Xa activity of Asian patients with atrial fibrillation compared with non-Asians in the ENGAGE AF-TIMI 48 trial.","AIMS


Prior studies suggested that the risks of ischaemic stroke and bleeding in patients of Asian race with atrial fibrillation (AF) may be higher than that of non-Asians. In the analysis of ENGAGE AF-TIMI 48 trial, we compared clinical outcomes, edoxaban concentration, and anti-factor Xa (anti-FXa) activity, between Asian and non-Asian races.
METHODS AND RESULTS


There were 2909 patients of Asian race and 18 195 non-Asian race in the ENGAGE AF-TIMI 48 trial. The risks of thromboembolism and bleeding events were compared for Asians and non-Asians treated with warfarin. The trough levels of edoxaban concentration and anti-FXa activity were also compared and correlated with the efficacy and safety of edoxaban vs. warfarin. Compared to non-Asian patients, the Asian population was on average 2 years younger and 20 kg lighter. In the warfarin group, the adjusted risk of ischaemic stroke did not differ significantly for patients of Asian and non-Asian race [adjusted hazard ratio (aHR) = 1.12, P = 0.56). Asians treated with warfarin had a higher-adjusted risk of intracranial haemorrhage (ICH: aHR 1.71, P = 0.03) compared with non-Asians. The trough edoxaban concentration and anti-FXa activity were 20-25% lower for Asians compared with non-Asians. Compared to warfarin, higher dose edoxaban significantly reduced ICH while preserving the efficacy of stroke prevention in both Asians and non-Asians. Two of three net clinical outcomes appeared to be more favourably reduced with edoxaban in Asians compared with non-Asians (Pint = 0.063 for primary, 0.037 for secondary, and 0.032 for third net clinical outcomes, respectively).
CONCLUSION


Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race.",2019,"Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race.","['Asian patients with atrial fibrillation', 'patients of Asian race with atrial fibrillation (AF', '2909 patients of Asian race and 18\u2009195 non-Asian race in the ENGAGE AF-TIMI 48 trial']","['edoxaban', 'warfarin', 'edoxaban vs. warfarin']","['adjusted risk of ischaemic stroke', 'risks of thromboembolism and bleeding events', 'clinical outcomes, edoxaban concentration, and anti-factor Xa (anti-FXa) activity', 'trough levels of edoxaban concentration and anti-FXa activity', 'trough edoxaban concentration and anti-FXa activity', 'intracranial haemorrhage', 'efficacy and safety', 'ICH']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0519727,"Compared to warfarin, higher dose edoxaban preserved the efficacy for stroke prevention and was associated with a favourable safety profile for Asians, which may be due to the lower trough edoxaban concentration and anti-FXa activity achieved in patients of Asian race.","[{'ForeName': 'Tze-Fan', 'Initials': 'TF', 'LastName': 'Chao', 'Affiliation': 'Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City 112, Taiwan.'}, {'ForeName': 'Shih-Ann', 'Initials': 'SA', 'LastName': 'Chen', 'Affiliation': 'Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City 112, Taiwan.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Hamershock', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development, 211 Mt. Airy Road, Basking Ridge, NJ USA.'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital, 60 Fenwood Road, 7th Floor, Suite 7022, Boston, MA, USA.""}]",European heart journal,['10.1093/eurheartj/ehy807']
797,31484660,Efficacy of Difluoromethylornithine and Aspirin for Treatment of Adenomas and Aberrant Crypt Foci in Patients with Prior Advanced Colorectal Neoplasms.,"Difluoromethylornithine (DFMO), an inhibitor of polyamine synthesis, was shown to act synergistically with a NSAID for chemoprevention of colorectal neoplasia. We determined the efficacy and safety of DFMO plus aspirin for prevention of colorectal adenomas and regression of rectal aberrant crypt foci (ACF) in patients with prior advanced adenomas or cancer. A double-blinded, placebo-controlled trial was performed in 104 subjects (age 46-83) randomized (1:1) to receive daily DFMO (500 mg orally) plus aspirin (325 mg) or matched placebos for one year. All polyps were removed at baseline. Adenoma number (primary endpoint) and rectal ACF (index cluster and total) were evaluated at a one year colonoscopy. ACF were identified by chromoendoscopy. Toxicity was monitored, including audiometry. Eighty-seven subjects were evaluable for adenomas or ACF modulation ( n  = 62). At one year of treatment, adenomas were detected in 16 (38.1%) subjects in the DFMO plus aspirin arm ( n  = 42) versus 18 (40.9%) in the placebo arm ( n  = 44;  P  = 0.790); advanced adenomas were similar ( n  = 3/arm). DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared with placebo ( P  = 0.036). Total rectal ACF burden was also reduced in the treatment versus the placebo arm relative to baseline (74% vs. 45%,  P  = 0.020). No increase in adverse events, including ototoxicity, was observed in the treatment versus placebo arms. While adenoma recurrence was not significantly reduced by one year of DFMO plus aspirin, the drug combination significantly reduced rectal ACF number consistent with a chemopreventive effect.",2019,DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared to placebo (p= 0.036).,"['Patients with Prior Advanced Colorectal Neoplasms', '104 subjects (age 46- 83', 'patients with prior advanced adenomas or cancer', 'Eighty-seven subjects were evaluable for adenomas or ACF modulation (n=62']","['daily DFMO', 'Difluoromethylornithine and Aspirin', 'DFMO plus aspirin', 'placebo', 'Difluoromethylornithine (DFMO', 'aspirin']","['Adenoma number (primary endpoint) and rectal ACF (index cluster and total', 'median number of rectal ACF', 'adenoma recurrence', 'Total rectal ACF burden', 'Toxicity', 'rectal aberrant crypt foci (ACF', 'adverse events, including ototoxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0009404', 'cui_str': 'Colorectal Tumors'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0002260', 'cui_str': 'Eflornithine'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}]",87.0,0.482134,DFMO plus aspirin was associated with a statistically significant reduction in the median number of rectal ACF compared to placebo (p= 0.036).,"[{'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota. sinicrope.frank@mayo.edu.'}, {'ForeName': 'Pruthvi R', 'Initials': 'PR', 'LastName': 'Velamala', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Louis M Wong Kee', 'Initials': 'LMWK', 'LastName': 'Song', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Viggiano', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Bruining', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Gostout', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kraichely', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Navtej S', 'Initials': 'NS', 'LastName': 'Buttar', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Schroeder', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kisiel', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mark V', 'Initials': 'MV', 'LastName': 'Larson', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Seth R', 'Initials': 'SR', 'LastName': 'Sweetser', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Sedlack', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Sinicrope', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Richmond', 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Asad', 'Initials': 'A', 'LastName': 'Umar', 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': ""Della'Zanna"", 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Joni S', 'Initials': 'JS', 'LastName': 'Noaeill', 'Affiliation': 'Divisions of Gastroenterology & Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Meyers', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Foster', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0167']
798,29469046,Treatment of Type-1 Hepatorenal Syndrome with Pentoxifylline: A Randomized Placebo Controlled Clinical Trial.,"INTRODUCTION


Type-1 hepatorenal syndrome (HRS-1) portends a poor prognosis in patients with cirrhosis. Currently available medical therapies are largely ineffective, save for liver transplantation. We aimed to determine if pentoxifylline (PTX) therapy in addition to the standard of care of volume expansion with albumin and vasoconstriction with midodrine and octreotide (AMO) is safe and efficacious compared to AMO in HRS-1 treatment.
MATERIAL AND METHODS


Hospitalized subjects with decompensated cirrhosis and HRS-1 were enrolled. PTX or placebo was administered with AMO therapy for up to 14 days. The primary endpoint was HRS-1 resolution (serum creatinine ≤ 1.5 g/dL for &gt; 24 h). Secondary endpoints were change in creatinine and MELD score, partial treatment response, 30-and 180-day overall and transplant free survival.
RESULTS


Twelve subjects with mean age 58.9 ± 6.2 years were enrolled and randomized. Mean MELD score was 26.5 ± 7.4 and 58.3% were male. Overall cohort 30- and 180-day survival was 58.3% and 33.3% respectively. Two subjects underwent liver transplantation. HRS-1 resolution (16.7% vs. 16.7%, p = 1.000), partial treatment response (33.3% vs. 16.7%, p = 0.505), change in creatinine (+0.48 g/dL, 95% CI -0.49-1.46 vs. +0.03 g/dL, 95% CI -0.64- 0.70, p = 0.427), 30-day survival (66.6% vs. 50.0%, p = 0.558) and 180-day survival (50.0% vs. 16.7%, p = 0.221) were similar between the two groups. Serious adverse events necessitating treatment discontinuation were rare (n = 1, PTX).
DISCUSSION


The addition of PTX to AMO in the treatment of HRS-1 is safe when compared to the current standard of care. Future large-scale prospective study to validate the efficacy of this treatment seems warranted.",2018,"HRS-1 resolution (16.7% vs. 16.7%, p = 1.000), partial treatment response (33.3% vs. 16.7%, p = 0.505), change in creatinine (+0.48 g/dL, 95% CI -0.49-1.46 vs. +0.03 g/dL, 95% CI -0.64- 0.70, p = 0.427), 30-day survival (66.6% vs. 50.0%, p = 0.558) and 180-day survival (50.0% vs. 16.7%, p = 0.221) were similar between the two groups.","['Twelve subjects with mean age 58.9 ± 6.2 years', 'Hospitalized subjects with decompensated cirrhosis and HRS-1 were enrolled', 'Two subjects underwent liver transplantation', 'patients with cirrhosis']","['PTX or placebo', 'Placebo', 'midodrine and octreotide (AMO', 'Pentoxifylline', 'pentoxifylline (PTX) therapy', 'AMO therapy']","['HRS-1 resolution', '30-day survival', 'change in creatinine and MELD score, partial treatment response, 30-and 180-day overall and transplant free survival', 'HRS-1 resolution (serum creatinine', 'change in creatinine', 'partial treatment response', '180-day survival', 'Mean MELD score']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1619727', 'cui_str': 'Decompensated cirrhosis of liver (disorder)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026078', 'cui_str': 'Midodrine'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",12.0,0.209734,"HRS-1 resolution (16.7% vs. 16.7%, p = 1.000), partial treatment response (33.3% vs. 16.7%, p = 0.505), change in creatinine (+0.48 g/dL, 95% CI -0.49-1.46 vs. +0.03 g/dL, 95% CI -0.64- 0.70, p = 0.427), 30-day survival (66.6% vs. 50.0%, p = 0.558) and 180-day survival (50.0% vs. 16.7%, p = 0.221) were similar between the two groups.","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Stine', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Department of Medicine.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Cornella', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Behm', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Henry', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}, {'ForeName': 'Neeral L', 'Initials': 'NL', 'LastName': 'Shah', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Northup', 'Affiliation': 'University of Virginia, Charlottesville, VA, United States. Division of Gastroenterology & Hepatology, Department of Medicine.'}]",Annals of hepatology,['10.5604/01.3001.0010.8660']
799,30587857,"Combined use of a healthy lifestyle smartphone application and usual primary care counseling to improve arterial stiffness, blood pressure and wave reflections: a Randomized Controlled Trial (EVIDENT II Study).","Our aim was to investigate the effects of an intervention that comprised a brief counseling session on lifestyle habits together with the use of the EVIDENT (Lifestyles and arterial aging) application on the modification of markers that indicated different hemodynamic functions, such as arterial stiffness, blood pressure or wave reflections. The EVIDENT II study (Lifestyles and arterial aging) is a randomized clinical trial with two parallel groups. Each participant had an initial visit and two follow-up visits at 3 and 12 months where the peripheral augmentation index-PAIx75 was measured by tonometry, while an oscillometric method was used for the cardio-ankle vascular index-CAVI and brachial-ankle pulse wave velocity-baPWV. Both groups (intervention-IG and control-CG) were briefly counseled on diet and exercise. The IG also received instructions on the use of the EVIDENT II application during the 3 months. The sample (N = 597; 52 ± 11 years; 64% women) was randomized into IG = 291 and CG = 306. Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0). There was also a nonsignificant reduction of the CAVI at 3 months in the IG. A group effect was observed in the measurement of the PAIx75 over the 12-month follow-up (p = 0.003). This interaction was only observed in women (p = 0.017). In conclusion, the use of the EVIDENT II application achieved a modification of the PAIx75, a marker of wave reflection and vascular tone, in women through lifestyle improvements (physical activity and adherence to the Mediterranean diet). No significant results were found regarding blood pressure or arterial stiffness markers.",2019,"Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0).",['The sample (N\u2009=\u2009597; 52\u2009±\u200911 years; 64% women'],['healthy lifestyle smartphone application and usual primary care counseling'],"['blood pressure or arterial stiffness markers', 'peripheral augmentation index-PAIx75', 'arterial stiffness, blood pressure and wave reflections', 'CAVI', 'arterial stiffness, blood pressure or wave reflections']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4034558', 'cui_str': 'Cardio-ankle vascular index'}]",,0.0223544,"Comparing groups, there was a decrease in the PAIx75 favorable to the IG at 3 months (-4.9%, 95% CI: -7.7 to -2.1) and 12 months (-3.9%, 95% CI: -6.8 to -1.0).","[{'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Recio-Rodríguez', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain. donrecio@gmail.com.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martin-Cantera', 'Affiliation': 'Primary Health Care Research Unit of Barcelona, Institute IDIAP-Jordi Gol, Barcelona, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martinez-Vizcaino', 'Affiliation': 'Center for Health and Social Research, University of Castilla-La Mancha, Cuenca, Spain.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Arietaleanizbeaskoa', 'Affiliation': 'Primary Health Care Research Unit of Bizkaia, Basque Health Service-Osakidetza, Bilbao, Spain.'}, {'ForeName': 'Natividad', 'Initials': 'N', 'LastName': 'Gonzalez-Viejo', 'Affiliation': 'Torre Ramona Health Center, Aragon Health Service, Zaragoza, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Menendez-Suarez', 'Affiliation': 'Casa del Barco Health Center, Castilla and León Health Service, Valladolid, Spain.'}, {'ForeName': 'Manuel A', 'Initials': 'MA', 'LastName': 'Gómez-Marcos', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Garcia-Ortiz', 'Affiliation': 'Primary Health Care Research Unit, The Alamedilla Health Center, Health Service of Castilla and Leon (SACYL), Biomedical Research Institute of Salamanca (IBSAL), Primary Care Prevention and Health Promotion Research Network (REDIAPP), Salamanca, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-018-0182-6']
800,31820806,Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial.,"STUDY QUESTION


Is there a difference in functional outcomes and recurrence rate between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 5 years postoperatively?
SUMMARY ANSWER


No evidence was found that long-term outcomes differed when nodule excision was compared to rectal resection for deeply invasive endometriosis involving the bowel.
WHAT IS KNOWN ALREADY


Functional outcomes of nodule excision and rectal resection for deeply invasive endometriosis involving the bowel are comparable 2 years after surgery. Despite numerous previously reported case series enrolling patients managed for colorectal endometriosis, long-term data remain scarce in the literature.
STUDY DESIGN, SIZE, DURATION


From March 2011 to August 2013, we performed a two-arm randomized trial, enrolling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring >20 mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference. Among them, 55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre. Institute review board approval was obtained to continue follow-up to 10 years postoperatively. One patient requested to stop the follow-up 2 years after surgery.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Patients underwent either nodule excision by shaving or disc excision, or segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of randomization results. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were values taken from the Knowles-Eccersley-Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36).
MAIN RESULTS AND THE ROLE OF CHANCE


Fifty-five patients were enrolled. Among the 27 patients in the excision arm, two were converted to segmental resection (7.4%). One patient managed by segmental resection withdrew from the study 2 years postoperatively, presuming that associated pain of other aetiologies may have jeopardized the outcomes. The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively. For excision and resection, the primary endpoint was present in 44.4% versus 60.7% of patients (P = 0.29), respectively, while 55.6% versus 53.6% of patients subjectively reported normal bowel movements (P = 1). An intention-to-treat comparison of overall KESS, GIQLI, Wexner, USP and SF36 scores did not reveal significant differences between the two arms 5 years postoperatively. Statistically significant improvement was observed shortly after surgery with no further improvement or impairment recorded 1-5 years postoperatively. During the 5-year follow-up, additional surgical procedures were performed in 25.9% versus 28.6% of patients who had undergone excision or resection (P = 0.80), respectively.
LIMITATIONS, REASONS FOR CAUTION


The presumption of a 40% difference concerning postoperative functional outcomes in favour of nodule excision resulted in a lack of power for demonstration of the primary endpoint difference.
WIDER IMPLICATIONS OF THE FINDINGS


Five-year follow-up data do not show statistically significant differences between conservative and radical rectal surgery for long-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum.
STUDY FUNDING/COMPETING INTEREST(S)


No specific funding was received. Patient enrolment and follow-up until 2 years postoperatively was supported by a grant from the clinical research programme for hospitals in France. The authors declare no competing interests related to this study.
TRIAL REGISTRATION NUMBER


This randomized study is registered with ClinicalTrials.gov, number NCT01291576.
TRIAL REGISTRATION DATE


31 January 2011.
DATE OF FIRST PATIENT’S ENROLMENT


7 March 2011.",2019,"The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively.","['55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre', '31 January 2011', 'Patients underwent either', '27 patients in the excision arm, two were converted to segmental resection (7.4', 'Fifty-five patients were enrolled', 'patients with large deep endometriosis infiltrating the rectum 5\xa0years postoperatively', '60 patients with deep endometriosis infiltrating the rectum up to 15\xa0cm from the anus, measuring >20\xa0mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference', 'From March 2011 to August 2013', 'deep endometriosis infiltrating the rectum']","['nodule excision and rectal resection', 'nodule excision by shaving or disc excision, or segmental resection', 'Excision versus colorectal resection', 'radical rectal surgery']","['functional outcomes and recurrence rate', 'recurrence rate for excision and resection', 'frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24\xa0months postoperatively', 'normal bowel movements', 'values taken from the Knowles-Eccersley-Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36', 'proportion of patients experiencing one of the following symptoms: constipation', 'overall KESS, GIQLI, Wexner, USP and SF36 scores']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003461', 'cui_str': 'Anus'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}]","[{'cui': 'C2939022', 'cui_str': 'Nodule excision'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0239978', 'cui_str': 'Increased frequency of defecation (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0403645', 'cui_str': 'Acontractile detrusor (disorder)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.122253,"The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively.","[{'ForeName': 'Horace', 'Initials': 'H', 'LastName': 'Roman', 'Affiliation': 'Endometriosis Center, Clinique Tivoli-Ducos, Bordeaux 33000, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Huet', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Bridoux', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Khalil', 'Affiliation': 'Department of Surgery, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Hennetier', 'Affiliation': 'Expert Center in the Diagnosis and Multidisciplinary Management of Endometriosis, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bubenheim', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital, Rouen 76031, France.'}, {'ForeName': 'Lacramioara Aurelia', 'Initials': 'LA', 'LastName': 'Branduse', 'Affiliation': 'Department of Public Health and Management, Carol Davila University of Medicine and Pharmacy Bucharest, Romania.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez217']
801,30624719,Relationship between body mass index and outcomes in patients with atrial fibrillation treated with edoxaban or warfarin in the ENGAGE AF-TIMI 48 trial.,"AIMS


To investigate the relationship between body mass index (BMI) and outcomes in patients with atrial fibrillation (AF).
METHODS AND RESULTS


In the ENGAGE AF-TIMI 48 trial, patients with AF were randomized to warfarin (international normalized ratio 2.0-3.0) or edoxaban. The cohort (N = 21 028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5%. In an adjusted analysis, higher BMI (continuous, per 5 kg/m2 increase) was significantly and independently associated with lower risks of stroke/systemic embolic event (SEE) [hazard ratio (HR) 0.88, P = 0.0001], ischaemic stroke/SEE (HR 0.87, P < 0.0001), and death (HR 0.91, P < 0.0001), but with increased risks of major (HR 1.06, P = 0.025) and major or clinically relevant non-major bleeding (HR 1.05, P = 0.0007). There was a significant interaction between sex and increasing BMI category, with lower risk of ischaemic stroke/SEE in males and increased risk of bleeding in women. Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >18.5 kg/m2, while time in therapeutic range for warfarin improved significantly as BMI increased (P < 0.0001). The effects of edoxaban vs. warfarin on stroke/SEE, major bleeding, and net clinical outcome were similar across BMI groups.
CONCLUSION


An increased BMI was independently associated with a lower risk of stroke/SEE, better survival, but increased risk of bleeding. The efficacy and safety profiles of edoxaban were similar across BMI categories ranging from 18.5 to >40.",2019,Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >,"['The cohort (N\u2009=\u200921\xa0028) included patients across BMI categories (kg/m2): underweight (<18.5) in 0.8%, normal (18.5 to <25) in 21.4%, overweight (25 to <30) in 37.6%, moderately obese (30 to <35) in 24.8%, severely obese (35 to <40) in 10.0%, and very severely obese (≥40) in 5.5', 'patients with atrial fibrillation treated with', 'patients with atrial fibrillation (AF', 'patients with AF']","['edoxaban', 'edoxaban or warfarin', 'warfarin', 'edoxaban vs. warfarin']","['BMI', 'risk of bleeding', 'Trough edoxaban concentration and anti-Factor Xa activity', 'death', 'major or clinically relevant non-major bleeding', 'lower risk of stroke/SEE, better survival', 'stroke/SEE, major bleeding, and net clinical outcome', 'lower risks of stroke/systemic embolic event (SEE', 'ischaemic stroke/SEE']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0443793', 'cui_str': 'Anti factor Xa (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",,0.116703,Trough edoxaban concentration and anti-Factor Xa activity were similar across BMI groups >,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Boriani', 'Affiliation': 'Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena & Reggio Emilia, Modena University Hospital, Via del Pozzo 71, Modena, Italy.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Kuder', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi Sankyo, Inc., Global Clinical Development Department, 211 Mount Airy Road, Basking Ridge, NJ, USA.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Global Medical Affairs Department, Zielstattstr. 48, Munich, Germany.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Rutman', 'Affiliation': 'Daiichi Sankyo, Inc., Global Clinical Development Department, 211 Mount Airy Road, Basking Ridge, NJ, USA.'}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Daiichi Sankyo, Inc., Global Clinical Development Department, 211 Mount Airy Road, Basking Ridge, NJ, USA.'}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA, USA.""}]",European heart journal,['10.1093/eurheartj/ehy861']
802,31677087,The effect of time spent outdoors during summer on daily blood glucose and steps in women with type 2 diabetes.,"This study investigated changes in glycemic control following a small increase in time spent outdoors. Women participants with type 2 diabetes (N = 46) wore an iBUTTON temperature monitor and a pedometer for 1 week and recorded their morning fasting blood glucose (FBG) daily. They went about their normal activities for 2 days (baseline) and were asked to add 30 min of time outdoors during Days 3-7 (intervention). Linear mixed effects models were used to test whether morning FBG values were different on days following intervention versus baseline days, and whether steps and/or heat exposure changed. Results were stratified by indicators of good versus poor glycemic control prior to initiation of the study. On average, blood glucose was reduced by 6.1 mg/dL (95% CI - 11.5, - 0.6) on mornings after intervention days after adjusting for age, BMI, and ambient weather conditions. Participants in the poor glycemic control group (n = 16) experienced a 15.8 mg/dL decrease (95% CI - 27.1, - 4.5) in morning FBG on days following the intervention compared to a 1.6 mg/dL decrease (95%CI - 7.7, 4.5) for participants in the good glycemic control group (n = 30). Including daily steps or heat exposure did not attenuate the association between intervention and morning FBG. The present study suggests spending an additional 30 min outdoors may improve glycemic control; however, further examination with a larger sample over a longer duration and determination of mediators of this relationship is warranted.",2020,"On average, blood glucose was reduced by 6.1 mg/dL (95% CI - 11.5, - 0.6) on mornings after intervention days after adjusting for age, BMI, and ambient weather conditions.","['Women participants with type 2 diabetes (N\u2009=\u200946', 'women with type 2 diabetes']",[],"['morning FBG values', 'glycemic control', 'morning fasting blood glucose (FBG) daily', 'time spent outdoors', 'blood glucose']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0490201,"On average, blood glucose was reduced by 6.1 mg/dL (95% CI - 11.5, - 0.6) on mornings after intervention days after adjusting for age, BMI, and ambient weather conditions.","[{'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Richardson', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Chmielewski', 'Affiliation': 'Physiology and Biophysics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Connor Y H', 'Initials': 'CYH', 'LastName': 'Wu', 'Affiliation': 'Department of Geospatial Informatics, Troy University, Troy, AL, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Evans', 'Affiliation': 'Center for the Study of Community Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'McClure', 'Affiliation': 'Department of Epidemiology and Biostatistics, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'Kathryn W', 'Initials': 'KW', 'LastName': 'Hosig', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Gohlke', 'Affiliation': 'Department of Population Health Sciences, Virginia Tech, Blacksburg, VA, USA. jgohlke@vt.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00113-5']
803,30535100,Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial.,"BACKGROUND


Gram-negative bacteremia is a major cause of morbidity and mortality in hospitalized patients. Data to guide the duration of antibiotic therapy are limited.
METHODS


This was a randomized, multicenter, open-label, noninferiority trial. Inpatients with gram-negative bacteremia, who were afebrile and hemodynamically stable for at least 48 hours, were randomized to receive 7 days (intervention) or 14 days (control) of covering antibiotic therapy. Patients with uncontrolled focus of infection were excluded. The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative, or distant complications; and readmission or extended hospitalization (>14 days). The noninferiority margin was set at 10%.
RESULTS


We included 604 patients (306 intervention, 298 control) between January 2013 and August 2017 in 3 centers in Israel and Italy. The source of the infection was urinary in 411 of 604 patients (68%); causative pathogens were mainly Enterobacteriaceae (543/604 [90%]). A 7-day difference in the median duration of covering antibiotics was achieved. The primary outcome occurred in 140 of 306 patients (45.8%) in the 7-day group vs 144 of 298 (48.3%) in the 14-day group (risk difference, -2.6% [95% confidence interval, -10.5% to 5.3%]). No significant differences were observed in all other outcomes and adverse events, except for a shorter time to return to baseline functional status in the short-course therapy arm.
CONCLUSIONS


In patients hospitalized with gram-negative bacteremia achieving clinical stability before day 7, an antibiotic course of 7 days was noninferior to 14 days. Reducing antibiotic treatment for uncomplicated gram-negative bacteremia to 7 days is an important antibiotic stewardship intervention.
CLINICAL TRIALS REGISTRATION


NCT01737320.",2019,"The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization (>14 days).","['604 patients (306 intervention, 298 control) between January 2013 and August 2017 in three centers in Israel and Italy', 'hospitalized patients', 'Patients with uncontrolled focus of infection were excluded', 'Inpatients with Gram-negative bacteremia, afebrile and hemodynamically stable for at least 48 hours']","['antibiotic therapy', 'Antibiotic Therapy']","['composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization', 'shorter time to return to baseline functional status', 'median duration of covering antibiotics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}]","[{'cui': 'C0338237', 'cui_str': 'Antibiotic therapy (procedure)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3249881', 'cui_str': 'Infection - suppurative (disorder)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",604.0,0.222348,"The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative or distant complications; and re-admission or extended hospitalization (>14 days).","[{'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Yahav', 'Affiliation': 'Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Franceschini', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Fidi', 'Initials': 'F', 'LastName': 'Koppel', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Turjeman', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Babich', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Bitterman', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Ami', 'Initials': 'A', 'LastName': 'Neuberger', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Ghanem-Zoubi', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Eliakim-Raz', 'Affiliation': 'Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Pertzov', 'Affiliation': 'Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Stern', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Dickstein', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Maroun', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Hiba', 'Initials': 'H', 'LastName': 'Zayyad', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Bishara', 'Affiliation': 'Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Alon', 'Affiliation': 'Department of Medicine B, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.'}, {'ForeName': 'Yonatan', 'Initials': 'Y', 'LastName': 'Edel', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine F, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Venturelli', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mussini', 'Affiliation': 'Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Italy.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Leibovici', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel.'}, {'ForeName': 'Mical', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Infectious Diseases Institute, Rambam Health Care Campus, Haifa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1054']
804,30552829,Breast lesion detection and characterization with contrast-enhanced magnetic resonance imaging: Prospective randomized intraindividual comparison of gadoterate meglumine (0.15 mmol/kg) and gadobenate dimeglumine (0.075 mmol/kg) at 3T.,"BACKGROUND


Contrast-enhanced magnetic resonance imaging (CE-MRI) of the breast is highly sensitive for breast cancer detection. Multichannel coils and 3T scanners can increase signal, spatial, and temporal resolution. In addition, the T 1  -reduction effect of a gadolinium-based contrast agent (GBCA) is higher at 3T. Thus, it might be possible to reduce the dose of GBCA at 3T without losing diagnostic information.
PURPOSE


To compare a three-quarter (0.075 mmol/kg) dose of the high-relaxivity GBCA gadobenate dimeglumine, with a 1.5-fold higher than on-label dose (0.15 mmol/kg) of gadoterate meglumine for breast lesion detection and characterization at 3T CE-MRI.
STUDY TYPE


Prospective, randomized, intraindividual comparative study.
POPULATION


Eligible were patients with imaging abnormalities (BI-RADS 0, 4, 5) on conventional imaging. Each patient underwent two examinations, 24-72 hours apart, one with 0.075 mmol/kg gadobenate and the other with 0.15 mmol/kg gadoterate administered in a randomized order. In all, 109 patients were prospectively recruited.
FIELD STRENGTH/SEQUENCE


3T MRI with a standard breast protocol (dynamic-CE, T 2  w-TSE, STIR-T 2  w, DWI).
ASSESSMENT


Histopathology was the standard of reference. Three blinded, off-site breast radiologists evaluated the examinations using the BI-RADS lexicon.
STATISTICAL TESTS


Lesion detection, sensitivity, specificity, and diagnostic accuracy were calculated per-lesion and per-region, and compared by univariate and multivariate analysis (Generalized Estimating Equations, GEE).
RESULTS


Five patients were excluded, leaving 104 women with 142 histologically verified breast lesions (109 malignant, 33 benign) available for evaluation. Lesion detection with gadobenate (84.5-88.7%) was not inferior to gadoterate (84.5-90.8%) (P ≥ 0.165). At per-region analysis, gadobenate demonstrated higher specificity (96.4-98.7% vs. 92.6-97.3%, P ≤ 0.007) and accuracy (96.3-97.8% vs. 93.6-96.1%, P ≤ 0.001) compared with gadoterate. Multivariate analysis demonstrated superior, reader-independent diagnostic accuracy with gadobenate (odds ratio = 1.7, P < 0.001 using GEE).
DATA CONCLUSION


A 0.075 mmol/kg dose of the high-relaxivity contrast agent gadobenate was not inferior to a 0.15 mmol/kg dose of gadoterate for breast lesion detection. Gadobenate allowed increased specificity and accuracy.
LEVEL OF EVIDENCE


1 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2019;49:1157-1165.",2019,"Multivariate analysis demonstrated superior, reader-independent diagnostic accuracy with gadobenate (odds ratio = 1.7, P < 0.001 using GEE).
","['Five patients were excluded, leaving 104 women with 142 histologically verified breast lesions (109 malignant, 33 benign) available for evaluation', '109 patients were prospectively recruited', 'Eligible were patients with imaging abnormalities (BI-RADS 0, 4, 5) on conventional imaging']","['gadolinium-based contrast agent (GBCA', 'contrast-enhanced magnetic resonance imaging', 'Contrast-enhanced magnetic resonance imaging (CE-MRI', 'gadoterate meglumine', 'high-relaxivity GBCA gadobenate dimeglumine', 'gadobenate dimeglumine', 'Multichannel coils and 3T scanners']","['Lesion detection with gadobenate', 'specificity', 'specificity and accuracy', 'accuracy', 'signal, spatial, and temporal resolution', 'Lesion detection, sensitivity, specificity, and diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0118538', 'cui_str': 'gadoterate meglumine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0209453', 'cui_str': 'Gadobenate dimeglumine'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C1097281', 'cui_str': '3-(DMP)-T'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1875994', 'cui_str': 'Gadobenate'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0428763', 'cui_str': 'Temporal resolution (observable entity)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]",109.0,0.0808301,"Multivariate analysis demonstrated superior, reader-independent diagnostic accuracy with gadobenate (odds ratio = 1.7, P < 0.001 using GEE).
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Clauser', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Helbich', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Kapetas', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pinker', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bernathova', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Woitek', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kaneider', 'Affiliation': 'Diagnose Zentrum Urania, Vienna, Austria.'}, {'ForeName': 'Pascal A T', 'Initials': 'PAT', 'LastName': 'Baltzer', 'Affiliation': 'Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26335']
805,30539266,"Randomized, double-blind, placebo-controlled, crossover study of the effects of repeated-dose caffeine on neurobehavioral performance during 48 h of total sleep deprivation.","RATIONALE


Caffeine is widely used as a countermeasure against neurobehavioral impairment during sleep deprivation. However, little is known about the pharmacodynamic profile of caffeine administered repeatedly during total sleep deprivation.
OBJECTIVES


To investigate the effects of repeated caffeine dosing on neurobehavioral performance during sleep deprivation, we conducted a laboratory-based, randomized, double-blind, placebo-controlled, crossover, multi-dose study of repeated caffeine administration during 48 h of sleep deprivation. Twelve healthy adults (mean age 27.4 years, six women) completed an 18-consecutive-day in-laboratory study consisting of three 48 h total sleep deprivation periods separated by 3-day recovery periods. During each sleep deprivation period, subjects were awakened at 07:00 and administered caffeine gum (0, 200, or 300 mg) at 6, 18, 30, and 42 h of wakefulness. The Psychomotor Vigilance Test and Karolinska Sleepiness Scale were administered every 2 h.
RESULTS


The 200 and 300 mg doses of caffeine mitigated neurobehavioral impairment across the sleep deprivation period, approaching two-fold performance improvements relative to placebo immediately after the nighttime gum administrations. No substantive differences were noted between the 200 mg and 300 mg caffeine doses, and adverse effects were minimal.
CONCLUSIONS


The neurobehavioral effects of repeated caffeine dosing during sleep deprivation were most evident during the circadian alertness trough (i.e., at night). The difference between the 200 mg and 300 mg doses, in terms of the mitigation of performance impairment, was small. Neither caffeine dose fully restored performance to well-rested levels. These findings inform the development of biomathematical models that more accurately account for the time of day and sleep pressure-dependent effects of caffeine on neurobehavioral performance during sleep loss.",2019,"No substantive differences were noted between the 200 mg and 300 mg caffeine doses, and adverse effects were minimal.
","['Twelve healthy adults (mean age 27.4\xa0years, six women) completed an 18-consecutive-day in-laboratory study consisting of three 48\xa0h total sleep deprivation periods separated by 3-day recovery periods', '48\xa0h of total sleep deprivation', '48\xa0h of sleep deprivation']","['repeated-dose caffeine', 'caffeine gum', 'placebo', 'caffeine']","['neurobehavioral performance', 'adverse effects', 'Psychomotor Vigilance Test and Karolinska Sleepiness Scale']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}]",12.0,0.218318,"No substantive differences were noted between the 200 mg and 300 mg caffeine doses, and adverse effects were minimal.
","[{'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA. devon.hansen@wsu.edu.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Defense Biotechnology High Performance Computing Software Applications Institute, Telemedicine and Advanced Technology Research, US Army Medical Research and Materiel Command, Fort Detrick, Frederick, MD, USA.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Wesensten', 'Affiliation': 'Air Traffic Organization, Federal Aviation Administration, Washington, DC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Layton', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Reifman', 'Affiliation': 'Department of Defense Biotechnology High Performance Computing Software Applications Institute, Telemedicine and Advanced Technology Research, US Army Medical Research and Materiel Command, Fort Detrick, Frederick, MD, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center and Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",Psychopharmacology,['10.1007/s00213-018-5140-0']
806,30535188,"A Randomized, Double-blinded, Placebo-controlled Trial of Sitagliptin for Reducing Inflammation and Immune Activation in Treated and Suppressed Human Immunodeficiency Virus Infection.","BACKGROUND


Dipeptidyl peptidase-4 (DPP-4) inhibitors have pleotropic anti-inflammatory and immune regulatory effects in addition to glucoregulation. We evaluated inflammation and immune markers in suppressed human immunodeficiency virus (HIV) infection during treatment with the DPP-4 inhibitor sitagliptin.
METHODS


Virologically suppressed adults with HIV without diabetes on stable antiretroviral therapy (ART) with ≥100/μL CD4 cells were randomized to 16 weeks of sitagliptin 100 mg/day vs placebo in a multicenter trial. The primary endpoint was the change in plasma soluble CD14 (sCD14) from baseline to week 15-16.
RESULTS


Ninety participants were randomized, and 42 from each arm were included in per-protocol analyses. Participants were 45% non-Hispanic white, 38% non-Hispanic black, and 15% Hispanic, with a median age of 51 years; 83% were male; and the median CD4 count was 602 cells/μL. At week 15-16, there was no difference in sCD14 change between the 2 arms (P = .69). Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10 (95% confidence interval, -57% to -35%) at week 15 (P < .001). There were no significant between-arm differences in other soluble biomarkers, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation. Sitagliptin was well tolerated.
CONCLUSIONS


Sixteen weeks of sitagliptin had no effect on sCD14 levels in virologically suppressed participants with HIV. CXCL10, a chemokine involved in atherogenesis that predicts non-AIDS events during ART, declined markedly with sitagliptin. This suggests that DPP-4 inhibition has the potential to reduce cardiovascular morbidity in treated HIV infection.
CLINICAL TRIALS REGISTRATION


NCT01426438.",2019,"Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10","['Evaluable participants were 45% non-Hispanic white, 38% non-Hispanic black, 15% Hispanic, median age of 51 years, 83% male, with median CD4 count 602 cells/mm 3', 'Treated and Suppressed HIV Infection', 'adults with HIV without diabetes mellitus on stable ART with ≥100/mm 3 CD4 cells', 'Ninety participants were randomized, and 42 from each arm were included in per-protocol analyses']","['placebo', 'sitagliptin 100 mg/d vs. placebo', 'Sitagliptin', 'Placebo', 'CXCL10', '\n\n\nDipeptidyl peptidase-4 (DPP-4) inhibitors']","['cardiovascular morbidity', 'tolerated', 'CXCL10', 'sCD14 change', 'change in plasma soluble CD14 (sCD14', 'soluble CD163, soluble CD26, interleukin-6, C-reactive protein, soluble tumour necrosis factor receptors I and II, total CD4 and CD8 counts, or markers of lymphocyte or monocyte activation', 'Additional soluble biomarkers, and lymphocyte and monocyte activation', 'sCD14 levels', 'Inflammation and Immune Activation']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C3653297', 'cui_str': 'Dipeptidyl peptidase 4 (DPP-4) inhibitors'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}]",90.0,0.579292,"Relative to placebo, the sitagliptin arm had 47% greater decline in CXCL10","[{'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jordan E', 'Initials': 'JE', 'LastName': 'Lake', 'Affiliation': 'University of Texas Health Science Center, Houston.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kinslow', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Coombs', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Floris-Moore', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Ribaudo', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Yarasheski', 'Affiliation': 'Washington University, St. Louis, Missouri.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1051']
807,31648006,"Power vs strength training to improve muscular strength, power, balance and functional movement in individuals diagnosed with Parkinson's disease.","BACKGROUND


Declines in strength and power are cardinal symptoms of Parkinson's disease (PD), a progressive neuromuscular disorder. Progressive resistance training (PRT) has been shown to reduce a wide variety of PD-related motor deficits; however, no study has examined differences between the two most common RT methodologies utilized in this population, high-load, low velocity strength training (ST) and low-load, high-velocity power training (PT). The primary purpose of this study was to compare the effects of ST and PT on measures of strength, power, balance and functional movement in persons with PD.
METHOD


Thirty-five persons with mild to moderate PD (Hoehm and Yahr Stages = 1-3; UPDRS Part III = 30.6 ± 14.0) were randomized into either a ST or PT group involving 12 weeks of supervised PRT (2 visits per week). Leg press (LP) and chest press (CP) muscular strength (1RM) and muscular peak power (PP) were assessed before and after the twelve week training period as primary outcome measures. In addition, secondary measures of balance (Berg Balance Assessment (BBA), dynamic posturography (DMA), Modified Falls Efficacy Scale (MFES)), functional movement (timed up-and-go), and quality of life (PDQ-39 summary index and Mobility subscore) were obtained at the same time points, given the impact of PD symptoms on fall probability and independence.
RESULTS


Repeated measures ANCOVA revealed significant improvements in LP 1RM (M diff  = 54.89 kg, 95% CI: 43.38, 66.40; p < .05; d = 3.38) and CP 1RM (M diff  = 7.33 kg, 95% CI: 4.75, 9.91; p < .05; d = 2.02). Additionally, significant improvements were seen in LP PP  (M diff  = 112.27 W, 95% CI: 56.03, 168.51; p < .05; d = 1.42) and CP PP  (M diff  = 52.1 W, 95% CI: 23.38, 80.86; p = .001; d = 1.29). No significant improvements were seen for any secondary outcome measures, however BBA scores were shown to significantly decrease following the intervention (M diff  = -1.686, 95% CI: -2.89, -0.482; p = .007 d = -0.96), although this change did not reach clinical significance (clinically meaningful change = ±4.0). In addition, the ST group demonstrated significantly poorer PDQ-39 SI  scores (M diff  = 4.96, 95% CI: 0.54, 9.38; p = .029), whereas the entire sample showed significantly poorer PDQ-39 MOB  scores (M diff  = 4.80, 95% CI: 0.17, 9.43; p = .043; d = 0.71).
CONCLUSIONS


Both ST and PT appear to be effective at reducing the neuromuscular deficits associated with PD; however, the use of these interventions for improving functional performance was not supported.",2019,"No significant improvements were seen for any secondary outcome measures, however BBA scores were shown to significantly decrease following the intervention (M diff  = -1.686, 95% CI: -2.89, -0.482; p = .007 d = -0.96), although this change did not reach clinical significance (clinically meaningful change = ±4.0).","['persons with PD', ""individuals diagnosed with Parkinson's disease"", 'Thirty-five persons with mild to moderate PD (Hoehm and Yahr Stages\u202f=\u202f1-3; UPDRS Part III\u202f=\u202f30.6\u202f±\u202f14.0']","['Progressive resistance training (PRT', 'ST or PT', 'Power vs strength training', 'ST and PT']","['CP 1RM', 'balance (Berg Balance Assessment (BBA), dynamic posturography (DMA), Modified Falls Efficacy Scale (MFES)), functional movement (timed up-and-go), and quality of life (PDQ-39 summary index and Mobility subscore', 'fall probability and independence', 'LP 1RM', 'LP PP', 'poorer PDQ-39 SI  scores', 'functional performance', 'Leg press (LP) and chest press (CP) muscular strength (1RM) and muscular peak power (PP', 'strength, power, balance and functional movement', 'PDQ-39 MOB  scores', 'muscular strength, power, balance and functional movement', 'BBA scores', 'CP PP']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1960377', 'cui_str': 'Assessment of sense of balance (procedure)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",35.0,0.0283854,"No significant improvements were seen for any secondary outcome measures, however BBA scores were shown to significantly decrease following the intervention (M diff  = -1.686, 95% CI: -2.89, -0.482; p = .007 d = -0.96), although this change did not reach clinical significance (clinically meaningful change = ±4.0).","[{'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Cherup', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Andrew N L', 'Initials': 'ANL', 'LastName': 'Buskard', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Keri L', 'Initials': 'KL', 'LastName': 'Strand', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Kirk B', 'Initials': 'KB', 'LastName': 'Roberson', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Michiels', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Kuhn', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Lopez', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'Laboratory of Neuromuscular Research and Active Aging, Department of Kinesiology and Sport Sciences, University of Miami, 1507 Levante Ave, Max Orovitz Building, Coral Gables 33146, FL, USA; Miller School of Medicine, Center on Aging, University of Miami, Miami, FL 33136, USA. Electronic address: jsignorile@miami.edu.'}]",Experimental gerontology,['10.1016/j.exger.2019.110740']
808,31665912,Combination treatment of autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy for type 2 diabetes mellitus: A randomized controlled trial.,"The objective of this study was to compare standard treatment versus the combination of intrapancreatic autologous stem cell (ASC) infusion and hyperbaric oxygen treatment (HBOT) before and after ASC in the metabolic control of patients with type 2 diabetes mellitus (T2DM). This study was a prospective, randomized controlled trial. The combined intervention consisted of 10 sessions of HBOT before the intrapancreatic infusion of ASC and 10 sessions afterwards. ASCs were infused into the main arterial supply of the pancreas to maximize the presence of the stem cells where the therapeutic effect is most desired. A total of 23 patients were included (control group = 10, intervention group = 13). Age, gender, diabetes duration, number of medications taken, body weight and height, and insulin requirements were recorded at baseline and every three months. Also, body mass index, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR) were measured every three months for one year. HbA1c was significantly lower in the intervention group compared with control throughout follow-up. Overall, 77% of patients in the intervention group and 30% of patients in the control group demonstrated a decrease of HbA1c at 180 days (compared with baseline) of at least 1 unit. Glucose levels were significantly lower in the intervention group at all timepoints during follow-up. C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively,  p  = 0.0021. CPGR was higher in the intervention group at all controls during follow-up. The requirement for insulin was significantly lower in the intervention group at 90, 180, 270, and 365 days. Combined therapy of intrapancreatic ASC infusion and HBOT showed increased metabolic control and reduced insulin requirements in patients with T2DM compared with standard treatment.",2019,"C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively,  p  ","['A total of 23 patients were included (control group = 10, intervention group = 13', 'patients with T2DM', 'type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['autologous bone marrow stem cell transplantation and hyperbaric oxygen therapy', 'intrapancreatic autologous stem cell (ASC) infusion and hyperbaric oxygen treatment (HBOT', 'intrapancreatic ASC infusion and HBOT']","['body mass index, fasting plasma glucose, C-peptide, and HbA1c, C-peptide/glucose ratio (CPGR', 'HbA1c', 'Age, gender, diabetes duration, number of medications taken, body weight and height, and insulin requirements', 'metabolic control and reduced insulin requirements', 'CPGR', 'requirement for insulin', 'C-peptide levels', 'Glucose levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0202100', 'cui_str': 'Insulin C-peptide measurement (procedure)'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}]",,0.0442099,"C-peptide levels were significantly higher in the intervention group during follow-up and at one year: 1.9 ± 1.0 ng/mL versus 0.7 ± 0.4 ng/mL in intervention versus control groups, respectively,  p  ","[{'ForeName': 'Esteban J', 'Initials': 'EJ', 'LastName': 'Estrada', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Decima', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bortman', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Roberti', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Elida Beatriz', 'Initials': 'EB', 'LastName': 'Romero', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Samaja', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Aldo Rodríguez', 'Initials': 'AR', 'LastName': 'Saavedra', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Martínez', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Gutiérrez', 'Affiliation': 'Hospital de Alta Complejidad Pte. Juan Domingo Perón, Formosa, Argentina.'}]",Cell transplantation,['10.1177/0963689719883813']
809,30522389,Intraclass Correlation Coefficients for Planning Cluster Randomized Trials in Community-Dwelling Older Adults.,"Objectives:  With the emerging trends, more cluster randomized trials will be conducted in older adults, where facilities are randomized rather than individuals. Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available. We document ICCs for measures commonly used in community-dwelling older adults and discuss implications.  Method:  Secondary analysis of a range of baseline measures from the  On the Move  cluster randomized trial, whose ICCs were computed using a linear mixed model.  Results:  Self-reported disability measures related to facility characteristics and sense of community had the greatest ICCs (>0.10), while mobility performance measures had 0.05 to 0.10, and cognitive measure 0.11.  Discussion:  The ICCs for measures commonly used in older adults are of a sufficient magnitude to have a substantial impact on planned sample size of a study and credibility of results, and should be taken into consideration in study planning and data analysis.",2020,"Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available.","['community-dwelling older adults', 'Community-Dwelling Older Adults', 'older adults']",[],['mobility performance measures'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0469596,"Similarity of individuals from a facility (intraclass correlation coefficient/ICC) plays a critical role, but not readily available.","[{'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Neelesh K', 'Initials': 'NK', 'LastName': 'Nadkarni', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wert', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'VanSwearingen', 'Affiliation': 'University of Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Brach', 'Affiliation': 'University of Pittsburgh, PA, USA.'}]",Journal of aging and health,['10.1177/0898264318816216']
810,30293208,Effect of Synbiotic and Probiotic Supplementation on Serum Levels of Endothelial Cell Adhesion Molecules in Hemodialysis Patients: a Randomized Control Study.,"The aim of this study was to investigate the effect of synbiotic and probiotic supplementation on serum vascular dysfunction and necrosis markers in hemodialysis (HD) patients. In this randomized, double-blind, placebo-controlled trial, 75 HD patients were randomly assigned to either the synbiotic or probiotic or placebo group. The patients in the synbiotic group received 15 g of prebiotics and 5 g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5 (2.7 × 10 7  CFU/g each) in sachets (n = 25), whereas the probiotic group received 5 g probiotics same to the first group with 15 g of maltodextrin powder in sachets (n = 25) and the placebo group received 20 g of maltodextrin powder in sachets (n = 25) for 12 weeks. At baseline and the end of the study, serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels were measured. Feces also were collected for microbiota colony counting. Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03). Serum levels of VCAM-1 and CK-18 were not significantly different between the groups. However, the reduction in serum levels of VCAM-1 in the synbiotic group was significantly higher in comparison to the placebo group (P = 0.01). Multivariate linear regression analysis revealed that ∆ phosphate was the sole independent determinant of ∆ICAM-1 (P = 0 < 001). The study indicated that synbiotic supplementation reduced serum ICAM-1 level, which is a risk factor for cardiovascular diseases in HD patients, but has no effect on the necrosis marker. Trial registration: www.irct.ir (IRCT2017041233393N1).",2019,"Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03).","['hemodialysis (HD) patients', '75 HD patients', 'HD patients', 'Hemodialysis Patients']","['placebo group received 20\xa0g of maltodextrin powder in sachets', 'placebo', 'maltodextrin powder in sachets', 'synbiotic and probiotic supplementation', 'synbiotic or probiotic or placebo', 'synbiotic supplementation', '15\xa0g of prebiotics and 5\xa0g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5', 'Synbiotic and Probiotic Supplementation']","['Serum levels of VCAM-1 and CK-18', 'serum levels of VCAM-1', 'Serum ICAM-1 level', 'serum vascular dysfunction and necrosis markers', 'serum ICAM-1 level', 'serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels', 'Serum Levels of Endothelial Cell Adhesion Molecules']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",75.0,0.220696,"Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03).","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haghighat', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. shahi334@gmail.com.'}, {'ForeName': 'Shokouh', 'Initials': 'S', 'LastName': 'Shayanpour', 'Affiliation': 'Department of Nephrology, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9477-9']
811,30389760,Trial of intraoperative cell salvage versus transfusion in ovarian cancer (TIC TOC): protocol for a randomised controlled feasibility study.,"INTRODUCTION


Ovarian cancer is the leading cause of death from gynaecological cancer, with more than 7000 new cases registered in the UK in 2014. In patients suitable for surgery, the National Institute of Health and Care Excellence guidance for treatment recommends surgical resection of all macroscopic tumour, followed by chemotherapy. The surgical procedure can be extensive and associated with substantial blood loss which is conventionally replaced with a donor blood transfusion. While often necessary and lifesaving, the use of donor blood is associated with increased risks of complications and adverse surgical outcomes. Intraoperative cell salvage (ICS) is a blood conservation strategy in which red cells collected from blood lost during surgery are returned to the patient thus minimising the use of donor blood. This is the protocol for a feasibility randomised controlled trial with an embedded qualitative study and feasibility economic evaluation. If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery.
METHODS AND ANALYSIS


Sixty adult women scheduled for primary or interval ovarian cancer surgery at participating UK National Health Service Trusts will be recruited and individually randomised in a 1:1 ratio to receive ICS reinfusion or donor blood (as required) during surgery. Participants will be followed up by telephone at 30 days postoperatively for adverse events monitoring and by postal questionnaire at 6 weeks and 3 monthly thereafter, to capture quality of life and resource use data. Qualitative interviews will capture participants' and clinicians' experiences of the study.
ETHICS AND DISSEMINATION


This study has been granted ethical approval by the South West-Exeter Research Ethics Committee (ref: 16/SW/0256). Results will be disseminated via peer-reviewed publications and will inform the design of a larger trial.
TRIAL REGISTRATION NUMBER


ISRCTN19517317.",2018,"If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery.
","['ovarian cancer (TIC TOC', 'Sixty adult women scheduled for primary or interval ovarian cancer surgery at participating UK National Health Service Trusts', 'ovarian cancer surgery']","['intraoperative cell salvage versus transfusion', 'ICS reinfusion or donor blood', 'Intraoperative cell salvage (ICS', 'ICS reinfusion versus donor blood transfusion']",[],"[{'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0005768'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",[],60.0,0.260001,"If feasible, a later definitive trial will test the effectiveness and cost-effectiveness of ICS reinfusion versus donor blood transfusion in ovarian cancer surgery.
","[{'ForeName': 'Khadra', 'Initials': 'K', 'LastName': 'Galaal', 'Affiliation': 'Gynaeoncology, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Pritchard', 'Affiliation': 'Research, Development and Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'NIHR research and Design Services (South West), NIHR South West Research Design Service, Plymouth, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wingham', 'Affiliation': 'Gynaecology, Royal Cornwall Hospital NHS Trust, Truro, UK.'}, {'ForeName': 'Elsa M R', 'Initials': 'EMR', 'LastName': 'Marques', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Faulds', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Research, Development and Innovation, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Patricia Jane', 'Initials': 'PJ', 'LastName': 'Vickery', 'Affiliation': 'Peninsula Clinical Trials Unit, Plymouth University, Plymouth, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ralph', 'Affiliation': 'Department of Anaesthesia, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ferreira', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ewings', 'Affiliation': 'NIHR research and Design Services (South West), NIHR South West Research Design Service, Plymouth, UK.'}]",BMJ open,['10.1136/bmjopen-2018-024108']
812,30298202,Similar neurocognitive outcomes after 48 weeks in HIV-1-infected participants randomized to continue tenofovir/emtricitabine + atazanavir/ritonavir or simplify to abacavir/lamivudine + atazanavir.,"Human immunodeficiency virus (HIV)-associated neurocognitive disorders can persist in many patients despite achieving viral suppression while on antiretroviral therapy (ART). Neurocognitive function over 48 weeks was evaluated using a Cogstate test battery assessing psychomotor function, attention, learning, and working memory in 293 HIV-1-infected, ART-experienced, and virologically suppressed adults. The ASSURE study randomized participants 1:2 to remain on tenofovir/emtricitabine (TDF/FTC) and ritonavir-boosted atazanavir (ATV/r) or simplify to abacavir/lamivudine + atazanavir (ABC/3TC + ATV). Neurocognitive z-scores were computed using demographically adjusted normative data and were classified as ""impaired"" (defined as either a z-score ≤ - 2 or having 2 or more standardized individual test z-scores ≤ - 1); while higher scores (equaling better performance) were classified as ""normal"". By z-scores, 54.7% of participants had impaired neurocognition at baseline and 50.2% at week 48. There were no significant differences (p < 0.05) in the baseline-adjusted performance between treatment groups for any individual test or by z-score. Specific demographic and medical risk factors were evaluated by univariate analysis for impact on neurocognitive performance. Factors with p < 0.10 were evaluated by backwards regression analysis to identify neurocognition-correlated factors after accounting for treatment, assessment, and baseline. Four risk factors at baseline for impaired neurocognition were initially identified: lower CD4 nadir lymphocyte counts, higher Framingham risk scores, and interleukin-6 levels, and a history of psychiatric disorder not otherwise specified, however none were found to moderate the effect of treatment on neurocognition. In this aviremic, treatment-experienced population, baseline-adjusted neurocognitive function remained stable and equivalent over 48 weeks with both TDF/FTC + ATV/r-treated and in the ART-simplified ABC/3TC + ATV treatment groups.",2019,There were no significant differences (p < 0.05) in the baseline-adjusted performance between treatment groups for any individual test or by z-score.,"['293 HIV-1-infected, ART-experienced, and virologically suppressed adults']","['continue tenofovir/emtricitabine + atazanavir/ritonavir', 'abacavir/lamivudine + atazanavir', 'tenofovir/emtricitabine (TDF/FTC) and ritonavir-boosted atazanavir (ATV/r) or simplify to abacavir/lamivudine + atazanavir (ABC/3TC + ATV']","['Specific demographic and medical risk factors', 'CD4 nadir lymphocyte counts, higher Framingham risk scores, and interleukin-6 levels', 'Neurocognitive function', 'Cogstate test battery assessing psychomotor function, attention, learning, and working memory', 'Neurocognitive z-scores']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1613391', 'cui_str': 'abacavir / Lamivudine'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.121753,There were no significant differences (p < 0.05) in the baseline-adjusted performance between treatment groups for any individual test or by z-score.,"[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'AIDS Neurological Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Maruff', 'Affiliation': 'Cogstate Ltd., Melbourne, Australia.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Ross', 'Affiliation': 'ViiV Healthcare Company, 5 Moore Drive, Research Triangle Park, NC, 27709, USA. lisa.l.ross@viivhealthcare.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wohl', 'Affiliation': 'AIDS Clinical Trials Unit, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Small', 'Affiliation': 'New York Medical College, Valhalla, NY, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Edelstein', 'Affiliation': 'Alameda County Medical Center, Oakland, CA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Shaefer', 'Affiliation': 'ViiV Healthcare Company, 5 Moore Drive, Research Triangle Park, NC, 27709, USA.'}]",Journal of neurovirology,['10.1007/s13365-018-0680-y']
813,30335527,You Mad? Using Anger Appeals to Promote Activism Intentions and Policy Support in the Context of Sugary Drink Marketing to Kids.,"One proposed solution to address childhood obesity is to limit children's exposure to advertising for sugar-sweetened beverages. Might persuasive appeals be able to channel anger toward the soda industry in order to promote support for marketing regulations and increase intentions to engage in activism around this issue? This study sought to answer this question by drawing on research in communication and psychology about the relationships between anger, persuasion, and activism-related outcomes. Participants ( N  = 551) were randomly assigned to read one of four messages about sugary drink marketing to kids, following a 2 (anger: high vs. low) × 2 (efficacy: high vs. low) design, or to a no-exposure control group. There was a main effect of the anger manipulation on policy support, which was driven by support for punitively oriented policies. Although no main effects were observed for activism intentions, mediation analyses indicated indirect effects of the anger and efficacy appeals on intentions by way of evoked anger and perceived efficacy, respectively. Contrary to expectations, messaging effects did not differ for pro-attitudinal and counter-attitudinal groups. Implications for public health advocacy and persuasion research are discussed.",2019,"Although no main effects were observed for activism intentions, mediation analyses indicated indirect effects of the anger and efficacy appeals on intentions by way of evoked anger and perceived efficacy, respectively.",['Participants (N\xa0=\xa0551'],"['sugary drink marketing to kids, following a 2 (anger: high vs. low']",['anger and efficacy appeals on intentions by way of evoked anger and perceived efficacy'],[],"[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}]",551.0,0.0280932,"Although no main effects were observed for activism intentions, mediation analyses indicated indirect effects of the anger and efficacy appeals on intentions by way of evoked anger and perceived efficacy, respectively.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Skurka', 'Affiliation': 'Department of Communication, Cornell University.'}]",Health communication,['10.1080/10410236.2018.1536943']
814,30385215,"The Community-targeted Self-management of Epilepsy and Mental Illness (C-TIME) initiative: A research, community, and healthcare administration partnership to reduce epilepsy burden.","AIMS


Comorbid mental health conditions (MHCs) such as depression and anxiety are common in people with epilepsy. Targeted Self-Management for Epilepsy and Mental Illness (TIME) is a behavioral program that targets mood symptoms in adults with epilepsy and comorbid MHCs. Building upon positive findings of a randomized controlled study to establish the efficacy of TIME, the Community-TIME (C-TIME) initiative assessed the implementation feasibility and pre-/post-outcomes of this new evidence-based epilepsy self-management intervention in a community setting and in collaboration with key stakeholders.
METHODS


The C-TIME program is a group-format curriculum-based intervention delivered in ten 60-90 sessions over the course of 12 weeks. The C-TIME initiative used research staff to guide intervention performance evaluation, staff of a regional epilepsy advocacy agency to assist with community engagement and a county mental health services agency to support the transition from science to service. Process evaluations included outreach and engagement efforts needed to reach people with epilepsy and MHCs, the barriers and facilitators to roll out, and the participants' retention and satisfaction. The primary intervention participant outcome was depressive symptom severity at 4-month follow-up.
RESULTS


Referrals came from a variety of sources and approximately 1 in 3 referrals resulted in an enrollment. Thirty individuals were enrolled in 3 ""cohorts"" of 10. The most common reason for not being enrolled postscreening was that individuals did not show up for the baseline evaluation. Mean age of participants was 49.1 (12.8) years, 50% (N = 15) female, 55.2% (N = 16) white, 34.5% (N = 10) African-American. With respect to participation, 2/3 of the enrolled sample attended at least 7 out of the maximum 10 C-TIME sessions. Mean number of C-TIME sessions attended was 6.9 (4.1). Five participants (17%) had family members attend the C-TIME sessions, although family members were encouraged to play a supportive rather than primary role. Four-month follow-up outcome evaluation was available for 66% of the enrolled group. There was a significant reduction in depression severity, and patient satisfaction was over 90%.
CONCLUSIONS


The C-TIME program can be successfully implemented in the community and is associated with improved outcomes in adults with epilepsy and comorbid MHCs. Continued and broader scale-up of C-TIME and similar approaches could reach larger groups of adults with epilepsy and improve the health of our communities.",2018,The C-TIME program can be successfully implemented in the community and is associated with improved outcomes in adults with epilepsy and comorbid MHCs.,"['Thirty individuals were enrolled in 3 ""cohorts"" of 10', 'Mean age of participants was 49.1 (12.8) years, 50% (N\u202f=\u202f15) female, 55.2% (N\u202f=\u202f16) white, 34.5% (N\u202f=\u202f10) African-American', 'people with epilepsy', 'adults with epilepsy and comorbid MHCs']",[],"['depression severity, and patient satisfaction', 'Mean number of C-TIME sessions', 'depressive symptom severity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024518', 'cui_str': 'Histocompatibility Complex'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0719058', 'cui_str': 'C-Time'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",30.0,0.0496014,The C-TIME program can be successfully implemented in the community and is associated with improved outcomes in adults with epilepsy and comorbid MHCs.,"[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry and of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Electronic address: Martha.sajatovic@uhhospitals.org.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Needham', 'Affiliation': 'Epilepsy Association, Cleveland, OH, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Colón-Zimmermann', 'Affiliation': 'Department of Psychiatry and of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Richter', 'Affiliation': 'Epilepsy Association, Cleveland, OH, USA.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry and of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA; Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Garrity', 'Affiliation': 'Alcohol, Drug Addiction and Mental Health Services Board of Cuyahoga County, Cleveland, OH, USA.'}, {'ForeName': 'Eleanor R', 'Initials': 'ER', 'LastName': 'Ryan', 'Affiliation': 'Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Storer', 'Affiliation': 'Neurological and Behavioral Outcomes Center, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Harper', 'Affiliation': 'Alcohol, Drug Addiction and Mental Health Services Board of Cuyahoga County, Cleveland, OH, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2018.10.004']
815,30350380,"Overnight Steady-State Infusions of Parenteral Nutrition on Myosin Heavy Chain Transcripts in Rectus Abdominis Muscle Related to Amino Acid Transporters, Insulin-like Growth Factor 1, and Blood Amino Acids in Patients Aimed at Major Surgery.","BACKGROUND


Evaluation of improvements by nutrition support to severely ill patients requires sensitive methods to demonstrate activation of protein synthesis in various tissues from groups with a limited number of patients to be statistically efficient. This study examines effects of standard parenteral nutrition (PN) on abdominal muscle transcripts of amino acid (AA) transporters, myosin heavy chains (MHCs), and the insulin-like growth factor 1 and its receptor (IGF-1/IGF-1R) in patients aimed at major surgery.
METHODS


Twenty-two randomized patients received steady-state PN (0.16 gN/kg/d, 30 kcal/kg/d) or saline infusions for 12 hours before operation. Blood samples and muscle biopsies were obtained at operation start. Muscle messenger RNA (mRNA) levels of AA transporters (solute carrier family members SNAT2, LAT1, LAT3, LAT4, TAUT, PAT1, CD98), IGF-1, IGF-1R, MHC isoforms (MHC1, MHC2A, MHC2X), and LAT3 protein were quantified and related to concentrations of AA, IGF-1, insulin, and metabolic substrates in blood.
RESULTS


Muscle mRNA LAT3, LAT4, IGF-1R, and MHC2A increased by PN infusion, with correlations to specific AA transporters and MHC isoforms (P < .01-.05). TAUT and LAT3 correlated to slow (MHC1) and fast (MHC2A, MHC2X) isoforms (P < .001-.02). Muscle IGF-1 mRNA correlated to plasma essential AAs, whereas IGF-1R mRNA was related to LAT3, MHC2A, and serum IGF-1 (P < .001-.03).
CONCLUSIONS


The results confirm that short-term preoperative PN activates transcription of AA transporters and myosin isoforms. Thus, combinations of methods on gene transcription and translation of muscle proteins can be applied to define efficient combinations of nutrition and hormones to catabolic patients in preoperative and postoperative settings.",2019,"RESULTS


Muscle mRNA LAT3, LAT4, IGF-1R, and MHC2A increased by PN infusion, with correlations to specific AA transporters and MHC isoforms (P < .01-.05).","['patients aimed at major surgery', 'Twenty-two randomized patients received', 'severely ill patients']","['steady-state PN', 'saline infusions', 'standard parenteral nutrition (PN']","['Muscle messenger RNA (mRNA) levels of AA transporters (solute carrier family members SNAT2, LAT1, LAT3, LAT4, TAUT, PAT1, CD98), IGF-1, IGF-1R, MHC isoforms (MHC1, MHC2A, MHC2X), and LAT3 protein', 'TAUT and LAT3 correlated to slow (MHC1) and fast (MHC2A, MHC2X) isoforms', 'Muscle mRNA LAT3, LAT4, IGF-1R, and MHC2A', 'Blood samples and muscle biopsies', 'LAT3, MHC2A, and serum IGF-1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C4019022', 'cui_str': 'Taut (qualifier value)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0024518', 'cui_str': 'Histocompatibility Complex'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",22.0,0.0586473,"RESULTS


Muscle mRNA LAT3, LAT4, IGF-1R, and MHC2A increased by PN infusion, with correlations to specific AA transporters and MHC isoforms (P < .01-.05).","[{'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Iresjö', 'Affiliation': 'Surgical Metabolic Research Lab, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Engström', 'Affiliation': 'Surgical Metabolic Research Lab, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Smedh', 'Affiliation': 'Surgical Metabolic Research Lab, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Lundholm', 'Affiliation': 'Surgical Metabolic Research Lab, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1458']
816,30095737,The Effect of Aspartate and Sodium Bicarbonate Supplementation on Muscle Contractile Properties Among Trained Men.,"Farney, TM, MacLellan, MJ, Hearon, CM, Johannsen, NM, and Nelson, AG. The effect of aspartate and sodium bicarbonate supplementation on muscle contractile properties among trained men. J Strength Cond Res 34(3): 763-770, 2020-The focus of this investigation was to examine the effects of aspartate and NaHCO3 supplementation on muscle contractile properties within trained men. Eleven men (21.9 ± 1.5 years) ingested supplementation as 4 conditions all separated by 1 week and included the following: placebo (PLA), L-aspartate (12.5 mg) (ASP), NaHCO3 (0.3 g·kg) (SBC), or combination of ASP and SBC (CBO). For each day of testing, participants performed 1 high-intensity exercise session along with a pre- and postexercise (pre- or postex) isometric mid thigh pull test to measure peak force (PF) production and rate of force development (RFD). Blood was collected for all testing sessions before and after the high-intensity exercise to determine ammonia accumulation (AMM). Exercise sessions consisted of 4 exercises: barbell thrusters, squat jumps, lunge jumps, and forward jumps, with the total amount of work being equated for all 4 exercises across all 4 testing sessions. Participants performed the exercises in the aforementioned order, which was designated as 1 round. Each participant performed 3 rounds, with the work-to-rest ratio being 20-second work, 30-second rest. A 1-minute rest was given between the rounds. There were no treatment effects (p > 0.05) for PF, RFD, or AMM. However, there was a significant main effect for supplement consumption for the total time of work with the ASP, SBC, and CBO treatments having a lower time to completion compared with the PLA treatment. Ammonia was significantly elevated postexercise (p = 0.004), whereas there were no differences from preexercise to postexercise for PF or RFD (p > 0.05). The only significant treatment × time interaction was for RFD (p = 0.03) with CBO increasing postexercise, with the other 3 treatments all decreasing postexercise. The combination of ASP and SBC together may have the potential to reduce fatigue by mitigating the effects of metabolic by-product accumulation.",2020,"Ammonia was significantly elevated postexercise (p = 0.004), whereas there were no differences from preexercise to postexercise for PF or RFD (p > 0.05).","['trained men', 'Eleven men (21.9 ± 1.5 years', 'Trained Men']","['ingested supplementation', 'J Strength Cond Res XX(X', 'Aspartate and Sodium Bicarbonate Supplementation', 'Exercise sessions consisted of 4 exercises: barbell thrusters, squat jumps, lunge jumps, and forward jumps, with the total amount of work being equated for all 4 exercises across all 4 testing sessions', 'high-intensity exercise session along with a pre- and postexercise (pre- or postex) isometric mid thigh pull test', 'placebo (PLA), L-aspartate (12.5 mg) (ASP), NaHCO3 (0.3 g·kg) (SBC), or combination of ASP and SBC (CBO', 'aspartate and NaHCO3 supplementation', 'aspartate and sodium bicarbonate supplementation']","['PF, RFD, or AMM', 'muscle contractile properties', 'elevated postexercise', 'Farney, TM, MacLellan, MJ, Hearon, CM, Johannsen, NM, and Nelson, AG', 'postexercise', 'peak force (PF) production and rate of force development (RFD', 'Muscle Contractile Properties']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0580846', 'cui_str': 'Does pull (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}]","[{'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0243107', 'cui_str': 'development'}]",,0.0378705,"Ammonia was significantly elevated postexercise (p = 0.004), whereas there were no differences from preexercise to postexercise for PF or RFD (p > 0.05).","[{'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Farney', 'Affiliation': 'Human Performance Laboratory, Department of Health and Kinesiology, Texas A&M University-Kingsville, Kingsville, Texas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'MacLellan', 'Affiliation': 'Biomechanics/Neuromuscular Control Laboratory, School of Kinesiology, Louisiana State University, Baton Rouge, Louisiana.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Hearon', 'Affiliation': 'Human Performance Laboratory, Department of Health and Kinesiology, Texas A&M University-Kingsville, Kingsville, Texas.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Johannsen', 'Affiliation': 'Biomechanics/Neuromuscular Control Laboratory, School of Kinesiology, Louisiana State University, Baton Rouge, Louisiana.'}, {'ForeName': 'Arnold G', 'Initials': 'AG', 'LastName': 'Nelson', 'Affiliation': 'Biomechanics/Neuromuscular Control Laboratory, School of Kinesiology, Louisiana State University, Baton Rouge, Louisiana.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002692']
817,30198318,"Effects of Heart Rate Reduction With Either Pyridostigmine or Ivabradine in Patients With Heart Failure: A Randomized, Double-Blind Study.","BACKGROUND


Heart rate (HR) reduction with ivabradine has been proved to reduce hospitalization and death from heart failure (HF). We sought to investigate whether pyridostigmine would effectively reduce HR in patients with chronic HF as compared with ivabradine.
METHODS


Twenty-one patients with HF who were in sinus rhythm with a resting HR over 70 bpm, despite optimal medical treatment, were included in a randomized, double-blind study comparing pyridostigmine versus ivabradine. The initial dose of ivabradine was 5 mg twice daily to reach a target HR between 50 and 60 bpm and could be titrated to a maximum of 7.5 mg twice daily. Pyridostigmine was used in a fixed dose of 30 mg 3 times daily.
RESULTS


The baseline HR for ivabradine and pyridostigmine groups was 89.1 (13.5) and 80.1 (7.2) bpm, respectively ( P  = .083). After 6 months of treatment, HR was significantly reduced to 64.8 (8.3) bpm in the ivabradine group ( P  = .0014) and 63.6 (5.9) bpm in the pyridostigmine group ( P  = .0001). The N-terminal pro-B-type natriuretic peptide was reduced in the ivabradine group (median: 1308.4 [interquartile range: 731-1896] vs 755.8 [134.5-1014] pg/mL;  P  = .027) and in the pyridostigmine group (132.8 [89.9-829] vs 100.7 [38-360] pg/mL;  P  = .002). Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups. Exercise capacity was improved in both groups, with increments in volume of oxygen utilization ( V ˙ O 2 ; ivabradine: 13.1 vs 15.6,  P  = .048; pyridostigmine: 13.3 vs 16.7,  P  = .032). Heart rate recovery in the first minute postexercise was improved with pyridostigmine (11.8 [3.9] vs 18 [6.5];  P  = .046), but not with ivabradine (13.3 [6.9] vs 14.1 [8.2];  P  = .70). No differences in either group were observed in the myocardial scintigraphy with 123-iodine-metaiodobenzylguanidine.
CONCLUSION


Both drugs significantly reduced HR, with improvements in exercise capacity and in neurohormonal and inflammatory profiles.",2019,"Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups.","['Patients With Heart Failure', 'Twenty-one patients with HF who were in sinus rhythm with a resting HR over 70 bpm, despite optimal medical treatment', 'patients with chronic HF as compared with ivabradine']","['ivabradine', 'Pyridostigmine or Ivabradine', 'pyridostigmine', 'pyridostigmine versus ivabradine', 'Pyridostigmine']","['Heart Rate Reduction', 'volume of oxygen utilization', 'HR', 'Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor', 'Heart rate recovery', 'exercise capacity and in neurohormonal and inflammatory profiles', 'Exercise capacity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C0034261', 'cui_str': 'Pyridostigmine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",21.0,0.262683,"Inflammatory markers interleukin-1, interleukin-6, and tumor necrosis factor were reduced in both groups.","[{'ForeName': 'Aline Sterque', 'Initials': 'AS', 'LastName': 'Villacorta', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Villacorta', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'José Antônio', 'Initials': 'JA', 'LastName': 'Caldas', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bernardo Campanário', 'Initials': 'BC', 'LastName': 'Precht', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pilar Barreto', 'Initials': 'PB', 'LastName': 'Porto', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Letícia Ubaldo', 'Initials': 'LU', 'LastName': 'Rodrigues', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Neves', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Analucia Rampazzo', 'Initials': 'AR', 'LastName': 'Xavier', 'Affiliation': 'Pathology Department, LAMAP, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Kanaan', 'Affiliation': 'Pathology Department, LAMAP, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Cláudio Tinoco', 'Initials': 'CT', 'LastName': 'Mesquita', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Antônio Cláudio Lucas', 'Initials': 'ACL', 'LastName': 'da Nóbrega', 'Affiliation': 'Postgraduate Program in Cardiovascular Sciences, Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248418799364']
818,30195728,"Effects of levocarnitine on cardiac function, urinary albumin, hs-CRP, BNP, and troponin in patients with coronary heart disease and heart failure.","OBJECTIVE


To investigate the effects of levocarnitine on cardiac function, urinary albumin (ALB), high-sensitivity C-reactive protein (hs-CRP), brain natriuretic peptide (BNP), and troponin in patients with coronary heart disease (CHD) and heart failure (HF).
METHODS


In total, 246 patients with CHD-caused HF were selected and randomly divided into Group A and Group B. A fully automatic biochemical analyzer was used to measure the levels of ALB, hs-CRP, BNP, and troponin in both groups of patients, and the expression levels of LVDD and LVEF were detected by cardiac color ultrasonography. Patients in Group B were intravenously injected with 3.0 g of levocarnitine, once per day. After 14 days, changes in levels of ALB, hs-CRP, BNP, troponin, LVDD, and LVEF in Group A patients were detected.
RESULTS


The effective cure rates of patients in both groups were 65.8% and 81.3%, respectively, and there was a statistically significant difference between the two groups (p < 0.05). After administration of levocarnitine, all indicators showed decreasing trends, but the LVEF level increased. Among them, patients treated with levocarnitine showed the most evident decrease in LVEF. Decrease in BNP was the largest (p < 0.05). Additionally, there was no statistical difference in incidence rate between the two groups (5.8% vs. 2.5%, p = 0.222).
CONCLUSION


Levocarnitine can effectively improve ALB, hs-CRP, BNP, troponin, and LVDD levels to improve cardiac function rating and thus improve cardiac function.",2020,"Levocarnitine can effectively improve ALB, hs-CRP, BNP, troponin, and LVDD levels to improve cardiac function rating and thus improve cardiac function.","['patients with coronary heart disease (CHD) and heart failure (HF', 'patients with coronary heart disease and heart failure', '246 patients with CHD-caused HF']","['levocarnitine', 'Levocarnitine']","['BNP', 'effective cure rates', 'levels of ALB, hs-CRP, BNP, and troponin', 'incidence rate', 'changes in levels of ALB, hs-CRP, BNP, troponin, LVDD, and LVEF', 'ALB, hs-CRP, BNP, troponin, and LVDD levels to improve cardiac function rating', 'LVEF', 'cardiac function, urinary albumin, hs-CRP, BNP, and troponin', 'cardiac function', 'cardiac function, urinary albumin (ALB), high-sensitivity C-reactive protein (hs-CRP), brain natriuretic peptide (BNP), and troponin', 'LVEF level', 'expression levels of LVDD and LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]","[{'cui': 'C0087163', 'cui_str': 'l-carnitine'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0912730', 'cui_str': 'aluminum boride'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",246.0,0.0283394,"Levocarnitine can effectively improve ALB, hs-CRP, BNP, troponin, and LVDD levels to improve cardiac function rating and thus improve cardiac function.","[{'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Emergency Internal Medicine, The First People's Hospital of Jining, Jining 272011, PR China.""}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Clinical Laboratory, People's Hospital of Lanshan District, Rizhao 276800, PR China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Respiration, People's Hospital of Zhangqiu District, Jinan 250000, PR China.""}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Magnetic Resonance, People's Hospital of Zhangqiu District, Jinan 250000, PR China.""}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, People's Hospital of Zhangqiu District, Jinan 250000, PR China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Emergent Intensive Care Unit, The First People's Hospital of Jining, Jining 272011, PR China. Electronic address: weiliu1225@163.com.""}]",Hellenic journal of cardiology : HJC = Hellenike kardiologike epitheorese,['10.1016/j.hjc.2018.08.006']
819,30076988,Protocol for the Imagine HEALTH Study: Guided imagery lifestyle intervention to improve obesity-related behaviors and salivary cortisol patterns in predominantly Latino adolescents.,"Innovative lifestyle interventions are needed to reduce type 2 diabetes risk in adolescents. This report describes the protocol of the Imagine HEALTH cluster randomized control trial, that tests an intervention based in Self-Determination Theory (SDT) and uses lifestyle education combined with the mind-body, complementary health modality of guided imagery (GI), to address obesity prevention and treatment in predominantly Latino adolescents. The primary aim is to determine the unique effects of each of the three major components of the 12-week lifestyle intervention (lifestyle education, stress reduction guided imagery, and lifestyle behavior guided imagery) compared to control on primary outcomes of physical activity (accelerometry), dietary intake (3-day recall), and stress biomarker levels (salivary cortisol). Secondary aims assess changes compared to controls in psychosocial outcomes (stress, well-being, depression), diabetes-related metabolic outcomes (adiposity, insulin resistance), maintenance of outcome changes for one year post-intervention, and SDT-based mediation of intervention effects. The development and rationale for each of the intervention components, study design, and outcome measurement processes are described. Adolescent participants recruited from four urban schools are cluster randomized by school into one of four arms of the 12-week (3-month) intervention, followed by 6 months of maintenance and 6 months of no contact. Outcome measures are assessed at the end of each period (3-, 9-, and 15-months). Results to date show successful recruitment of 97% of the target study population. Future results will demonstrate the effects of this integrative intervention on primary and secondary outcome measures in adolescents at risk for lifestyle-related metabolic disease.",2018,"Secondary aims assess changes compared to controls in psychosocial outcomes (stress, well-being, depression), diabetes-related metabolic outcomes (adiposity, insulin resistance), maintenance of outcome changes for one year post-intervention, and SDT-based mediation of intervention effects.","['Adolescent participants recruited from four urban schools', 'predominantly Latino adolescents', 'adolescents', 'adolescents at risk for lifestyle-related metabolic disease']","['Innovative lifestyle interventions', 'lifestyle intervention (lifestyle education, stress reduction guided imagery, and lifestyle behavior guided imagery', 'Self-Determination Theory (SDT) and uses lifestyle education combined with the mind-body, complementary health modality of guided imagery (GI', 'imagery lifestyle intervention']","['psychosocial outcomes (stress, well-being, depression), diabetes-related metabolic outcomes (adiposity, insulin resistance), maintenance of outcome changes for one year post-intervention, and SDT-based mediation of intervention effects', 'physical activity (accelerometry), dietary intake (3-day recall), and stress biomarker levels (salivary cortisol', 'obesity-related behaviors and salivary cortisol patterns']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025517', 'cui_str': 'Thesaurismosis'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0680727', 'cui_str': 'Negotiation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0293792,"Secondary aims assess changes compared to controls in psychosocial outcomes (stress, well-being, depression), diabetes-related metabolic outcomes (adiposity, insulin resistance), maintenance of outcome changes for one year post-intervention, and SDT-based mediation of intervention effects.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weigensberg', 'Affiliation': 'USC Keck School of Medicine, Department of Pediatrics, United States. Electronic address: weigensb@usc.edu.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': 'USC Dornsife Center for Economic and Social Research, Department of Psychology, United States; USC Keck School of Medicine, Department of Preventive Medicine, United States.'}, {'ForeName': 'Cheng K Fred', 'Initials': 'CKF', 'LastName': 'Wen', 'Affiliation': 'USC Keck School of Medicine, Department of Preventive Medicine, United States.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'University of Texas at Austin, Department of Nutritional Sciences, United States.'}, {'ForeName': 'Quintilia', 'Initials': 'Q', 'LastName': 'Ávila', 'Affiliation': 'USC Keck School of Medicine, Department of Pediatrics, United States.'}, {'ForeName': 'Magaly', 'Initials': 'M', 'LastName': 'Juarez', 'Affiliation': 'USC Keck School of Medicine, Department of Pediatrics, United States.'}, {'ForeName': 'Niquelle', 'Initials': 'N', 'LastName': 'Brown-Wadé', 'Affiliation': 'USC Keck School of Medicine, Department of Preventive Medicine, Division of Biostatistics, United States.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Lane', 'Affiliation': 'USC Keck School of Medicine, Department of Preventive Medicine, Division of Biostatistics, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.07.009']
820,31560794,Effects of a toothpaste containing 0.3% triclosan on periodontal parameters of subjects enrolled in a regular maintenance program: A secondary analysis of a 2-year randomized clinical trial.,"BACKGROUND


The triclosan-containing dentifrices are effective in controlling biofilm formation and maintaining gingival health; however, there is limited information on their effects during the periodontal maintenance phase. Therefore, the aim of this study was to evaluate the clinical effects of a toothpaste containing 0.3% triclosan on the periodontal parameters of subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program.
METHODS


Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected. Sixty days post-surgery (baseline), subjects were randomized into two groups: (1) toothpaste containing 0.3% triclosan + 2.0% PVM/MA copolymer + 1450 ppm fluoride (test) or (2) toothpaste containing 1450 ppm fluoride (control), and were instructed to brush with the assigned toothpaste twice/day for 2 years. They received clinical monitoring at baseline, 3, 6, 12, 18, and 24 months, and professional maintenance every 3 months.
RESULTS


Eighty-eight subjects with natural teeth were enrolled in the study (Test, n = 39; Control, n = 49). The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (P < 0.05). The mean percentage of sites with probing depth ≥5 mm was reduced over the course of the study only in the test group (P < 0.05).
CONCLUSION


A toothpaste containing 0.3% triclosan was more effective than a regular fluoride toothpaste in improving the periodontal clinical condition around natural teeth of periodontally healthy subjects enrolled in a regular maintenance program for 2 years.",2020,The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (p<0.05).,"['periodontally healthy subjects enrolled in a regular maintenance program for 2 years', 'subjects enrolled in a regular maintenance program', 'Subjects presenting at least one implant with peri-implantitis and received surgical anti-infective therapy were selected', 'Eighty-eight subjects with natural teeth were enrolled in the study (Test, n: 39; Control, n:49', 'subjects that have been treated for peri-implantitis and were enrolled in a regular maintenance program']","['toothpaste containing 0.3% triclosan', 'regular fluoride toothpaste', 'i)toothpaste containing 0.3% triclosan+2.0% PVM/MA copolymer (Gantrez™)+1450 ppm fluoride (test) or (ii)toothpaste containing 1450 ppm fluoride (control']","['periodontal clinical condition', 'levels of plaque', 'percentage of sites exhibiting bleeding', 'periodontal parameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1141958', 'cui_str': 'Anti-infective therapy'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0596383', 'cui_str': 'Copolymer'}, {'cui': 'C0118823', 'cui_str': 'Gantrez'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",88.0,0.0368354,The test group showed a greater reduction in the percentage of sites exhibiting bleeding on probing (primary outcome) and lower levels of plaque in comparison with the control group after 24 months (p<0.05).,"[{'ForeName': 'Bernal', 'Initials': 'B', 'LastName': 'Stewart', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Jamil Awad', 'Initials': 'JA', 'LastName': 'Shibli', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'School of Dentistry, Maringa University, Maringa, Paraná, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Fotinos', 'Initials': 'F', 'LastName': 'Panagakos', 'Affiliation': 'Colgate-Palmolive Technology Center, Piscataway, New Jersey, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Matarazzo', 'Affiliation': 'School of Dentistry, Maringa University, Maringa, Paraná, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Mairink', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Onuma', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Faveri', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology and Implantology, Dental Research Division, Guarulhos University, Guarulhos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.18-0501']
821,29808120,Effects of Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy: A Randomized Controlled Trial.,"Background


Constraint-induced movement therapy (CIMT) is effective in improving motor outcomes after stroke. However, its existing protocols are resource-intensive and difficult to implement. The aim of this study is to design an easier CIMT protocol using number of repetitions of shaping practice.
Method


The study design was randomized controlled trial. Participants within 4 weeks after stroke were recruited at Murtala Muhammad Specialist Hospital. They were randomly assigned to groups A, B, C, and D. Group A received 3 hours of traditional therapy. Groups B, C, and D received modified CIMT consisting of 3 hours of shaping practice per session, 300 repetitions of shaping practice in 3 sessions, and 600 repetitions of shaping practice in 3 sessions per day, respectively, and constraint for 90% of the waking hours. All treatment protocols were administered 5 times per week for 4 weeks. The primary outcome was measured using upper limb Fugl-Meyer assessment, while the secondary outcome was measured using motor activity log, Wolf Motor Function Test, and upper limb self-efficacy test at baseline, 2 weeks, and 4 weeks after intervention.
Result


There were 48 participants 4 weeks after intervention. The result showed that there was no significant difference between groups at baseline ( p  > 0.05). Within-group improvements attained minimal clinically important difference (MCID) in modified CIMT and 300 repetitions and 600 repetitions groups.
Conclusion


Number of repetitions of shaping practice significantly improved motor function, real-world arm use, and upper limb self-efficacy after stroke. Therefore, it seems to be a simple alternative for the use of number of hours.
Trial Registration


This trial is registered with Pan African Clinical Trial Registry (registration number: PACTR201610001828172) (date of registration: 21/10/2016).",2018,"Within-group improvements attained minimal clinically important difference (MCID) in modified CIMT and 300 repetitions and 600 repetitions groups.
","['48 participants 4 weeks after intervention', 'Participants within 4 weeks after stroke were recruited at Murtala Muhammad Specialist Hospital']","['\n\n\nConstraint-induced movement therapy (CIMT', 'Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy']","['motor function, real-world arm use, and upper limb self-efficacy', 'upper limb Fugl-Meyer assessment', 'motor activity log, Wolf Motor Function Test, and upper limb self-efficacy test']","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.185072,"Within-group improvements attained minimal clinically important difference (MCID) in modified CIMT and 300 repetitions and 600 repetitions groups.
","[{'ForeName': 'Auwal', 'Initials': 'A', 'LastName': 'Abdullahi', 'Affiliation': 'Department of Physiotherapy, Bayero University Kano, Kano, Kano State, Nigeria.'}]",Neurology research international,['10.1155/2018/5496408']
822,30095507,Effectiveness of an Exercise-Based Active Rehabilitation Intervention for Youth Who Are Slow to Recover After Concussion.,"OBJECTIVE


(1) To determine the impact of providing participants aged 8 to 17 years who are slow to recover after a concussion with a well-developed active rehabilitation intervention (ARI), compared with receiving standard care alone, on postconcussion symptoms (PCS) at 2 and 6 weeks after the initiation of ARI; and (2) to investigate functional recovery 6 weeks after initiation of ARI.
DESIGN


A multicenter prospective quasi-experimental control group design.
SETTING


Tertiary care pediatric trauma center and community health care providers.
PARTICIPANTS


Forty-nine youth were enrolled (experimental n = 36; control n = 13).
PROCEDURES


Participants were assessed on 3 different occasions: (1) initial visit (baseline); (2) 2 weeks; and (3) 6 weeks after enrollment.
MAIN OUTCOME MEASURES


Child- and parent-reported PCS were obtained by the PCS Inventory Scale (primary outcome). Secondary outcomes included: (1) mood and anxiety; (2) quality of life; (3) energy level; (4) coordination and balance; (5) neurocognition; (6) parental anxiety; and (7) satisfaction with intervention.
RESULTS


Both groups reported decrease of PCS over time (child: P = 0.01; parent: P = 0.03). Children in the experimental group presented higher quality of life (P = 0.04) and less anger (P = 0.02). A trend toward significance was observed for better tandem gait (P = 0.07) and for less general fatigue on self-reported PCS (P = 0.09) in the experimental group.
CONCLUSIONS


Active rehabilitation intervention does not affect the PCS beyond the usual management, but it increases their quality of life, decreases anger, and potentially increases energy level and balance.",2020,Children in the experimental group presented higher quality of life (P = 0.04) and less anger (P = 0.02).,"['participants aged 8 to 17 years who are slow to recover after a concussion with a well-developed active rehabilitation intervention (ARI), compared with receiving standard care alone, on postconcussion symptoms (PCS', 'Tertiary care pediatric trauma center and community health care providers', 'Youth', 'Forty-nine youth were enrolled (experimental n = 36; control n = 13']","['Exercise-Based Active Rehabilitation Intervention', 'Active rehabilitation intervention']","[' (1) mood and anxiety; (2) quality of life; (3) energy level; (4) coordination and balance; (5) neurocognition; (6) parental anxiety; and (7) satisfaction with intervention', 'tandem gait', 'higher quality of life', 'PCS Inventory Scale', 'PCS over time']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0086034', 'cui_str': 'Community Health Care'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231779', 'cui_str': 'Heel toe gait (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",49.0,0.072986,Children in the experimental group presented higher quality of life (P = 0.04) and less anger (P = 0.02).,"[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Gauvin-Lepage', 'Affiliation': 'Faculty of Nursing, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Friedman', 'Affiliation': ""The Montreal Children's Hospital Trauma Centre, McGill University Health Centre, Montreal, QC, Canada.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Grilli', 'Affiliation': ""MTBI Program and Concussion Clinic, The Montreal Children's Hospital Trauma Centre, McGill University Health Centre, Montreal, QC, Canada.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sufrategui', 'Affiliation': ""MTBI Program and Concussion Clinic, The Montreal Children's Hospital Trauma Centre, McGill University Health Centre, Montreal, QC, Canada.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'De Matteo', 'Affiliation': 'School of Rehabilitation Sciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Grant L', 'Initials': 'GL', 'LastName': 'Iverson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gagnon', 'Affiliation': 'School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Montreal, QC, Canada.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000634']
823,31647503,"Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial.","Importance


Prospective assessment of treatments known to benefit patients in global clinical trials in specific racial groups is essential.
Objective


To compare the efficacy, safety, and tolerability of adding pertuzumab to trastuzumab and docetaxel vs placebo, trastuzumab, and docetaxel in Asian patients with ERBB2-positive early or locally advanced breast cancer.
Design, Setting, and Participants


This multicenter, double-blind, placebo-controlled phase 3 trial enrolled 329 women with ERBB2-positive early (T2-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) and primary tumor larger than 2 cm from March 14, 2016, to March 13, 2017. Analysis of the primary end point was performed on an intention-to-treat basis.
Interventions


Before surgery, patients received 4 cycles of intravenous pertuzumab (840-mg loading dose and 420-mg maintenance doses), trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), and docetaxel (75 mg/m2) or intravenous placebo, trastuzumab, and docetaxel every 3 weeks. After surgery, patients received 3 cycles of intravenous fluorouracil, epirubicin, and cyclophosphamide followed by 13 cycles of the same intravenous anti-ERBB2 therapy (pertuzumab and trastuzumab or placebo and trastuzumab) for up to 1 year.
Main Outcomes and Measures


The primary end point was independent review committee-assessed total pathologic complete response rate. The 2-sided Cochran-Mantel-Haenszel test, stratified by disease category and hormone receptor status, was used to compare rates between treatment groups.
Results


In total, 329 female patients were randomized (pertuzumab, 219; and placebo, 110; mean [SD] age, 48.8 [9.5] years). In the intention-to-treat population, total pathologic complete response rates were 39.3% (86 of 219) in the pertuzumab group and 21.8% (24 of 110) in the placebo group (difference, 17.5% [95% CI, 6.9%-28.0%]; P = .001). Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]). Serious adverse events were reported in 10.1% of patients (22 of 218) in the pertuzumab group and 8.2% of patients (9 of 110) in the placebo group.
Conclusions and Relevance


Treatment with pertuzumab, trastuzumab, and docetaxel resulted in a statistically significant improvement in the total pathologic complete response rate vs placebo, trastuzumab, and docetaxel for the neoadjuvant treatment of ERBB2-positive early or locally advanced breast cancer in Asian patients. Safety data were in line with the known pertuzumab safety profile and generally comparable between treatment groups. The PEONY trial adds to the totality of data showing the benefit of the pertuzumab regimen.
Trial Registration


ClinicalTrials.gov identifier: NCT02586025.",2020,"Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]).","['Asian patients', 'Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia', ' 110; mean [SD] age, 48.8 [9.5] years', 'Asian patients with ERBB2-positive early or locally advanced breast cancer', '329 women with ERBB2-positive early (T2-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) and primary tumor larger than 2 cm from March 14, 2016, to March 13, 2017', '329 female patients']","['trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), and docetaxel', 'Pertuzumab, Trastuzumab, and Docetaxel', 'ERBB2 therapy (pertuzumab and trastuzumab or placebo and trastuzumab', 'intravenous fluorouracil, epirubicin, and cyclophosphamide', 'intravenous pertuzumab', 'placebo', 'placebo, trastuzumab, and docetaxel', 'pertuzumab to trastuzumab and docetaxel vs placebo, trastuzumab, and docetaxel', 'pertuzumab, trastuzumab, and docetaxel']","['efficacy, safety, and tolerability', 'total pathologic complete response rate', 'total pathologic complete response rates', 'neutropenia', 'Efficacy, Safety, and Tolerability', 'Serious adverse events', 'review committee-assessed total pathologic complete response rate']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}]",329.0,0.274601,"Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]).","[{'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Pang', 'Affiliation': 'Breast Surgery, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Hongjian', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Breast Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Medicine-Oncology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Shusen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Medicine-Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Shude', 'Initials': 'S', 'LastName': 'Cui', 'Affiliation': 'Department of Breast Disease, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Liao', 'Affiliation': 'Department of Breast Disease, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Breast Disease Center, Shandong Cancer Hospital, Jinan, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Yuan-Ching', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of General Surgery, Mackay Memorial Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Hweichung', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Surgery, China Medical University Hospital, Taichung City, Taiwan.'}, {'ForeName': 'Seok Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'Seo', 'Affiliation': 'Division of Oncology/Hematology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Breast Disease Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Suphawat', 'Initials': 'S', 'LastName': 'Laohawiriyakamol', 'Affiliation': 'Department of Surgery, Songklanagarind Hospital, Songkhla, Thailand.'}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""Medicine-Oncology, The Affiliated Hospital of Military Medical Sciences (The 307th Hospital of Chinese People's Liberation Army), Beijing, China.""}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Biometrics, Roche Product Development, Shanghai, China.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Althaus', 'Affiliation': 'Product Development Oncology, Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Yixiang', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Roche Product Development, Shanghai, China.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Eng-Wong', 'Affiliation': 'Product Development Oncology, Genentech, Inc, South San Francisco, California.'}]",JAMA oncology,['10.1001/jamaoncol.2019.3692']
824,29912763,Factors Associated With Adenoma Detection in Propofol-sedated Patients.,"GOALS


To assess the factors associated with adenoma detection in propofol-sedated patients.
BACKGROUNDS


Low adenoma detection rate (ADR) are linked to increased risk of interval cancer and related deaths. Compared with air insufflation (AI) colonoscopy, the method of water exchange (WE) significantly decreased insertion pain and increased ADR in unsedated patients. Deep sedation with propofol has been increasingly used in colonoscopy. One report suggested that WE significantly increased ADR in propofol-sedated patients, but the factors associated with adenoma detection were not analyzed.
STUDY


Post hoc multiple logistic regression analyses were performed based on pooled data from 2 randomized controlled trials to assess the factors associated with adenoma detection in propofol-sedated patients.
RESULTS


Propofol-sedated patients (n=510) were randomized to AI and WE. The baseline characteristics were comparable. Multiple logistic regression analyses show that age, withdrawal time, indications (screening vs. diagnostic), and WE were significantly and independently associated with higher ADR. WE had fewer patients with inadequate Boston Bowel Preparation Scale score of <6. Despite a significantly shorter inspection time, WE had significantly higher overall ADR than AI, especially in those with adequate Boston Bowel Preparation Scale of ≥6. Right colon ADR (17.5% vs. 10.5%), flat ADR (32.3% vs. 19.4%), combined advanced and sessile serrated ADR (13.1% vs. 7.4%) of WE were significantly higher than those of AI.
CONCLUSIONS


WE enhanced quality of colonoscopy in propofol-sedated patients by significantly improving colon cleanliness and overall ADR. Colonoscopists with patients under propofol sedation might consider evaluating WE method for performance improvement.",2019,"Compared with air insufflation (AI) colonoscopy, the method of water exchange (WE) significantly decreased insertion pain and increased ADR in unsedated patients.","['sedated patients', 'unsedated patients', 'sedated Patients', 'sedated patients (n=510']","['air insufflation (AI) colonoscopy', 'Propofol', 'propofol']","['quality of colonoscopy', 'flat ADR', 'ADR', 'insertion pain and increased ADR', 'Right colon ADR', 'inadequate Boston Bowel Preparation Scale score', 'colon cleanliness and overall ADR']","[{'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",510.0,0.0273162,"Compared with air insufflation (AI) colonoscopy, the method of water exchange (WE) significantly decreased insertion pain and increased ADR in unsedated patients.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills and David Geffen School of Medicine at UCLA, Los Angeles, CA.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Koo', 'Affiliation': 'Departments of Medical Research.'}, {'ForeName': 'Yu-Hsi', 'Initials': 'YH', 'LastName': 'Hsieh', 'Affiliation': 'Medicine, Division of Gastroenterology, Dalin Tzu Chi Hospital, Dalin, Chiayi.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tseng', 'Affiliation': 'Medicine, Division of Gastroenterology, Dalin Tzu Chi Hospital, Dalin, Chiayi.'}, {'ForeName': 'Chi-Tan', 'Initials': 'CT', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Tzu Chi University.'}, {'ForeName': 'Linhui', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yanglin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': ""Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Felix W', 'Initials': 'FW', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Sepulveda Ambulatory Care Center, Veterans Affairs Greater Los Angeles Healthcare System, North Hills and David Geffen School of Medicine at UCLA, Los Angeles, CA.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001080']
825,30095506,Can Ultrasound Identify Paradoxical Vocal Fold Movement? A Pilot Study.,"OBJECTIVE


Vocal cord dysfunction (VCD) is characterized by paradoxical vocal fold movement (PVFM) during inspiration. The aim of this study was to determine whether ultrasound could accurately differentiate between normal and PVFM during respirations in a resting state.
DESIGN


Prospective, single-subject design.
SETTING


Academic medical center.
PATIENTS


A speech-language pathologist who was able to volitionally alternate between normal and PVFM when breathing at rest was recruited to participate in the study.
INTERVENTIONS


The subject was instructed to randomly alternate between normal and PVFM 20 times (10 times each). A single investigator imaged the vocal folds using ultrasound and reported when the subject alternated between the 2 respiratory states.
MAIN OUTCOME MEASURES


The subject recorded when they changed between the 2 respiratory states, whether the investigator identified with the change occurred, and if the correct respiratory state was identified.
RESULTS


The investigator recognized when the subject changed respiratory states and correctly identified the new respiratory state 100% of the time.
CONCLUSIONS


The findings of the current study were promising and suggest that ultrasound may have utility in the diagnosis of VCD. However, because of the preliminary nature of these results, further research is required before recommending its clinical implementation.",2020,"The investigator recognized when the subject changed respiratory states and correctly identified the new respiratory state 100% of the time.
","['A speech-language pathologist who was able to volitionally alternate between normal and PVFM when breathing at rest was recruited to participate in the study', 'Academic medical center']",[],[],"[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0334866', 'cui_str': 'Pathologists'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]",[],[],,0.0208644,"The investigator recognized when the subject changed respiratory states and correctly identified the new respiratory state 100% of the time.
","[{'ForeName': 'Jonathan T', 'Initials': 'JT', 'LastName': 'Finnoff', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Orbelo', 'Affiliation': 'Department of Otolaryngology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Ekbom', 'Affiliation': 'Department of Otolaryngology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000641']
826,30006887,Action plan interrupted: resolution of proactive interference while coordinating execution of multiple action plans during sleep deprivation.,"The ability to retain an action plan to execute another is necessary for most complex, goal-directed behavior. Research shows that executing an action plan to an interrupting event can be delayed when it partly overlaps (vs. does not overlap) with the retained action plan. This phenomenon is known as partial repetition costs (PRCs). PRCs reflect proactive interference, which may be resolved by inhibitory, executive control processes. We investigated whether these inhibitory processes are compromised due to one night of sleep deprivation. Participants were randomized to a sleep-deprived group or a well-rested control group. All participants performed an action planning task at baseline after a full night of sleep, and again either after a night of sleep deprivation (sleep-deprived group) or a full night of sleep (control group). In this task, two visual events occurred in a sequence. Participants retained an action plan to the first event in working memory while executing a speeded action to the second (interrupting) event; afterwards, they executed the action to the first event. The two action plans either partly overlapped (required the same hand) or did not (required different hands). Results showed slower responses to the interrupting event during sleep deprivation compared to baseline and the control group. However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group. Thus, one night of sleep deprivation slowed global responses to the interruption, but inhibitory processes involved in reducing proactive interference while responding to an interrupting event were not compromised. These findings are consistent with other studies that show sleep deprivation degrades global task performance, but does not necessarily degrade performance on isolated, executive control components of cognition. The possibility that our findings involve local as opposed to central inhibition is also discussed.",2020,"However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group.",[],"['action planning task at baseline after a full night of sleep, and again either after a night of sleep deprivation (sleep-deprived group) or a full night of sleep (control group', 'sleep-deprived group or a well-rested control group']",[],[],"[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0135948,"However, the magnitude of the PRCs was no different during sleep deprivation compared to baseline and the control group.","[{'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, WA, USA. lfournier@wsu.edu.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Stubblefield', 'Affiliation': 'Department of Psychology, Washington State University, Pullman, WA, USA.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, Spokane, WA, USA.'}]",Psychological research,['10.1007/s00426-018-1054-z']
827,31621832,Chemoprophylaxis Vaccination: Phase I Study to Explore Stage-specific Immunity to Plasmodium falciparum in US Adults.,"BACKGROUND


Chemoprophylaxis vaccination with sporozoites (CVac) with chloroquine induces protection against a homologous Plasmodium falciparum sporozoite (PfSPZ) challenge, but whether blood-stage parasite exposure is required for protection remains unclear. Chloroquine suppresses and clears blood-stage parasitemia, while other antimalarial drugs, such as primaquine, act against liver-stage parasites. Here, we evaluated CVac regimens using primaquine and/or chloroquine as the partner drug to discern whether blood-stage parasite exposure impacts protection against homologous controlled human malaria infection.
METHODS


In a Phase I, randomized, partial double-blind, placebo-controlled study of 36 malaria-naive adults, all CVac subjects received chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received postexposure primaquine (CVac-primaquine/chloroquine arm). Drug control subjects received primaquine, chloroquine, and uninfected mosquito bites. After a chloroquine washout, subjects, including treatment-naive infectivity controls, underwent homologous, PfSPZ controlled human malaria infection and were monitored for parasitemia for 21 days.
RESULTS


No serious adverse events occurred. During CVac, all but 1 subject in the study remained blood-smear negative, while only 1 subject (primaquine/chloroquine arm) remained polymerase chain reaction-negative. Upon challenge, compared to infectivity controls, 3/3 chloroquine arm subjects displayed delayed patent parasitemia (P = .01) but not sterile protection, while 3/11 primaquine/chloroquine subjects remained blood-smear negative.
CONCLUSIONS


CVac-primaquine/chloroquine is safe and induces sterile immunity to P. falciparum in some recipients, but a single 45 mg dose of primaquine postexposure does not completely prevent blood-stage parasitemia. Unlike previous studies, CVac-chloroquine did not produce sterile immunity.
CLINICAL TRIALS REGISTRATION


NCT01500980.",2020,No serious adverse events occurred.,"['36 malaria-naïve adults, all CVac subjects received', 'U.S. adults']","['primaquine, chloroquine, and uninfected mosquito bites', 'CVac-primaquine/chloroquine', 'Chemoprophylaxis vaccination', 'chloroquine or primaquine', 'placebo', 'primaquine/chloroquine', 'chloroquine prophylaxis and bites from 12-15 P. falciparum-infected mosquitoes (CVac-chloroquine arm) at 3 monthly iterations, and some received post-exposure primaquine (CVac-primaquine/chloroquine arm', 'primaquine', 'Chloroquine', 'CVac-chloroquine', 'chloroquine']","['blood smear-negative', 'blood-stage parasitemia', 'blood smear negative', 'delayed patent parasitemia']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0417744', 'cui_str': 'Mosquito bite (disorder)'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0005768'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0030650', 'cui_str': 'Patent'}]",,0.0560313,No serious adverse events occurred.,"[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Healy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Murphy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Jen C C', 'Initials': 'JCC', 'LastName': 'Hume', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shelton', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Kuntz', 'Affiliation': 'Department of Medicine, Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Wesley C', 'Initials': 'WC', 'LastName': 'Van Voorhis', 'Affiliation': 'Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Moodie', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Metch', 'Affiliation': 'Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Ruobing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Silver-Brace', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fishbaugher', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Olivia C', 'Initials': 'OC', 'LastName': 'Finney', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Chaturvedi', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Marcsisin', 'Affiliation': 'Military Malaria Research Program, Division of Experimental Therapeutics, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Charlotte V', 'Initials': 'CV', 'LastName': 'Hobbs', 'Affiliation': 'Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Warner-Lubin', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Talley', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Wong-Madden', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Stuart', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Department of Laboratory Medicine and Microbiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Kappe', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kublin', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Duffy', 'Affiliation': 'Center for Infectious Disease Research, Seattle, Washington, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1010']
828,31524941,Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial.,"Importance


The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) randomized clinical trial was stopped early owing to the efficacy of low-dose rivaroxaban plus aspirin in preventing major cardiovascular events. The main reason for early trial termination was the effect of combination therapy on reducing ischemic strokes.
Objective


To analyze the association between low-dose rivaroxaban with or without aspirin and different ischemic stroke subtypes.
Design, Setting, and Participants


This is a secondary analysis of a multicenter, double-blind, randomized, placebo-controlled study that was performed in 33 countries from March 12, 2013, to May 10, 2016. Patients with stable atherosclerotic vascular disease were eligible, and a total of 27 395 participants were randomized and followed up to February 6, 2017. All first ischemic strokes and uncertain strokes that occurred by this date were adjudicated using TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria. The analysis of ischemic stroke subtypes was evaluated using an intention-to-treat principle. Statistical analysis was performed from March 12, 2013, to February 6, 2017.
Interventions


Participants received rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban (5 mg twice a day), or aspirin (100 mg once a day).
Main Outcomes and Measures


Risk of ischemic stroke subtypes during follow-up.
Results


A total of 291 patients (66 women; mean [SD] age, 69.4 [8.5] years; 43 [14.8%] had a previous nonlacunar stroke) experienced an ischemic stroke. During the study, 49 patients (16.8%) received a diagnosis of atrial fibrillation. Applying TOAST criteria, 59 strokes (20.3%) were cardioembolic, 54 strokes (18.6%) were secondary to greater than 50% stenosis of the ipsilateral internal carotid artery, 42 strokes (14.4%) had a negative evaluation that met criteria for embolic stroke of undetermined source, and 21 strokes (7.2%) were secondary to small vessel disease. There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30 [95% CI, 0.12-0.74]; P = .006) in the combination therapy group compared with the aspirin-only group. A trend for reduction in strokes secondary to small vessel disease (HR, 0.36 [95% CI, 0.12-1.14]; P = .07) was not statistically significant. No significant difference was observed between the 2 groups in strokes secondary to greater than 50% carotid artery stenosis (HR, 0.85 [95% CI, 0.45-1.60]; P = .61). Rivaroxaban, 5 mg, twice daily showed a trend for reducing cardioembolic strokes compared with aspirin (HR, 0.57 [95% CI, 0.31-1.03]; P = .06) but was not associated with reducing other stroke subtypes.
Conclusions and Relevance


For patients with systemic atherosclerosis, low-dose rivaroxaban plus aspirin was associated with large, significant reductions in cardioembolic strokes and embolic strokes of undetermined source. However, these results of exploratory analysis need to be independently confirmed before influencing clinical practice.
Trial Registration


ClinicalTrials.gov identifier: NCT01776424.",2020,"There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30","['33 countries from March 12, 2013, to May 10, 2016', '49 patients (16.8%) received a diagnosis of atrial fibrillation', 'patients with systemic atherosclerosis', 'Patients with stable atherosclerotic vascular disease were eligible, and a total of 27\u202f395 participants were randomized and followed up to February 6, 2017', '291 patients (66 women; mean [SD] age, 69.4 [8.5] years; 43 [14.8%] had a previous nonlacunar stroke) experienced an ischemic stroke', 'and Ischemic Stroke Subtypes']","['Rivaroxaban With or Without Aspirin', 'rivaroxaban', 'rivaroxaban with or without aspirin', 'placebo', 'TOAST', 'aspirin', 'Rivaroxaban', 'rivaroxaban plus aspirin']","['Measures\n\n\nRisk of ischemic stroke subtypes during follow-up', 'cardioembolic strokes', 'cardioembolic strokes and embolic strokes', 'embolic strokes', 'ischemic strokes']","[{'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C0262469', 'cui_str': 'Embolic stroke (disorder)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}]",59.0,0.590201,"There were significantly fewer cardioembolic strokes (hazard ratio [HR], 0.40 [95% CI, 0.20-0.78]; P = .005) and embolic strokes of undetermined source (HR, 0.30","[{'ForeName': 'Kanjana S', 'Initials': 'KS', 'LastName': 'Perera', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kelvin K H', 'Initials': 'KKH', 'LastName': 'Ng', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sumiti', 'Initials': 'S', 'LastName': 'Nayar', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Catanese', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Bosch', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA neurology,['10.1001/jamaneurol.2019.2984']
829,31520525,No effect of triheptanoin on exercise performance in McArdle disease.,"OBJECTIVE


To study if treatment with triheptanoin, a 7-carbon triglyceride, improves exercise tolerance in patients with McArdle disease. McArdle patients have a complete block in glycogenolysis and glycogen-dependent expansion of tricarboxylic acid cycle (TCA), which may restrict fat oxidation. We hypothesized that triheptanoin metabolism generates substrates for the TCA, which potentially boosts fat oxidation and improves exercise tolerance in McArdle disease.
METHODS


Double-blind, placebo-controlled, crossover study in patients with McArdle disease completing two treatment periods of 14 days each with a triheptanoin or placebo diet (1 g/kg/day). Primary outcome was change in mean heart rate during 20 min submaximal exercise on a cycle ergometer. Secondary outcomes were change in peak workload and oxygen uptake along with changes in blood metabolites and respiratory quotients.
RESULTS


Nineteen of 22 patients completed the trial. Malate levels rose on triheptanoin treatment versus placebo (8.0 ± SD2.3 vs. 5.5 ± SD1.8 µmol/L, P < 0.001), but dropped from rest to exercise (P < 0.001). There was no difference in exercise heart rates between triheptanoin (120 ± SD16 bpm) and placebo (121 ± SD16 bpm) treatments. Compared with placebo, triheptanoin did not change the submaximal respiratory quotient (0.82 ± SD0.05 vs. 0.84 ± SD0.03), peak workload (105 ± SD38 vs. 102 ± SD31 Watts), or peak oxygen uptake (1938 ± SD499 vs. 1977 ± SD380 mL/min).
INTERPRETATION


Despite increased resting plasma malate with triheptanoin, the increase was insufficient to generate a normal TCA turnover during exercise and the treatment has no effect on exercise capacity or oxidative metabolism in patients with McArdle disease.",2019,"Compared with placebo, triheptanoin did not change the submaximal respiratory quotient (0.82 ± SD0.05 vs. 0.84 ± SD0.03), peak workload (105 ± SD38 vs. 102 ± SD31 Watts), or peak oxygen uptake (1938 ± SD499 vs. 1977 ± SD380 mL/min).
","['1\xa0g/kg/day', 'patients with McArdle disease', 'Nineteen of 22 patients completed the trial', 'McArdle disease', 'patients with McArdle disease completing two treatment periods of 14\xa0days each with a']","['triheptanoin, a 7-carbon triglyceride', 'placebo', 'placebo, triheptanoin', 'triheptanoin or placebo diet', 'triheptanoin']","['complete block in glycogenolysis and glycogen-dependent expansion of tricarboxylic acid cycle (TCA', 'exercise capacity or oxidative metabolism', 'submaximal respiratory quotient', 'peak workload (105\xa0±\xa0SD38 vs. 102\xa0±\xa0SD31\xa0Watts), or peak oxygen uptake', 'exercise heart rates', 'mean heart rate during 20\xa0min submaximal exercise on a cycle ergometer', 'Malate levels', 'change in peak workload and oxygen uptake along with changes in blood metabolites and respiratory quotients', 'exercise performance', 'exercise tolerance']","[{'cui': 'C1532536', 'cui_str': 'g/kg/day'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017924', 'cui_str': 'Myophosphorylase deficiency'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C2604598', 'cui_str': 'triheptanoin'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0596624', 'cui_str': 'Glycogenolysis'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0008858', 'cui_str': 'Tricarboxylic Acid Cycle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439261', 'cui_str': 'watt (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0024546', 'cui_str': 'Malates'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005768'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}]",,0.436338,"Compared with placebo, triheptanoin did not change the submaximal respiratory quotient (0.82 ± SD0.05 vs. 0.84 ± SD0.03), peak workload (105 ± SD38 vs. 102 ± SD31 Watts), or peak oxygen uptake (1938 ± SD499 vs. 1977 ± SD380 mL/min).
","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Laforêt', 'Affiliation': 'Centre de référence des maladies neuromusculaires Nord/Est/Ile de France, Service de Neurologie, Hôpital Raymond-Poincaré, AP-HP, Garches, France.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Buch', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads G', 'Initials': 'MG', 'LastName': 'Stemmerik', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ottolenghi', 'Affiliation': 'Metabolomics Unit, Service des Explorations fonctionnelles, Necker Hospital and Descartes University of Paris, AP-HP, Paris, France.'}, {'ForeName': 'Stéphane N', 'Initials': 'SN', 'LastName': 'Hatem', 'Affiliation': 'Institute of Cardiometabolism and Nutrition, La Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Raaschou-Pedersen', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nanna S', 'Initials': 'NS', 'LastName': 'Poulsen', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Atencio', 'Affiliation': 'Inserm U 1127, CNRS UMR 7225, ICM, F-75013, Paris, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Luton', 'Affiliation': 'Inserm U 1127, CNRS UMR 7225, ICM, F-75013, Paris, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Ceccaldi', 'Affiliation': 'Institute of Cardiometabolism and Nutrition, La Pitié-Salpêtrière Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Haller', 'Affiliation': 'Neuromuscular Center, Institute for Exercise and Environmental Medicine of Texas Health Presbyterian Hospital, Dallas, Texas.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': 'MRC Centre for Neuromuscular Diseases, National Hospital for Neurology and Neurosurgery, Queen Square, London, England.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Mochel', 'Affiliation': 'Inserm U 1127, CNRS UMR 7225, ICM, F-75013, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark.'}]",Annals of clinical and translational neurology,['10.1002/acn3.50863']
830,29502458,Project reach: Piloting a risk-tailored smoking cessation intervention for lung screening.,"The purpose of this study was to explore the feasibility, acceptability, and efficacy of a telephone-based smoking cessation intervention for lung screening patients. Participants ( N  = 39) were enrolled in a single-arm pilot study of a four-session telephone-based intervention. Self-report measures were completed at baseline, post-intervention, and 3-month follow-up. Participants were long-term smokers; 62 percent were not motivated to quit. Twenty-three percent attempted quitting, 29 percent decreased their smoking, and 11 percent reported abstinence. Confidence increased ( p  < .001) and there were trends toward increased importance ( p  = .09) and comparative disease risk ( p  = .02). This intervention was acceptable and associated with improvements in smoking-related beliefs and behaviors.",2020,Confidence increased ( p < .001) and there were trends toward increased importance ( p = .09) and comparative disease risk ( p = .02).,"['Participants ( N\u2009=\u200939', 'lung screening patients', 'lung screening']","['telephone-based smoking cessation intervention', 'risk-tailored smoking cessation intervention']","['abstinence', 'feasibility, acceptability, and efficacy', 'comparative disease risk', 'smoking-related beliefs and behaviors']","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.02117,Confidence increased ( p < .001) and there were trends toward increased importance ( p = .09) and comparative disease risk ( p = .02).,"[{'ForeName': 'Inga T', 'Initials': 'IT', 'LastName': 'Lennes', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Alaina L', 'Initials': 'AL', 'LastName': 'Carr', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Strauss', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Ponzani', 'Affiliation': 'Massachusetts General Hospital, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Massachusetts General Hospital, USA.'}]",Journal of health psychology,['10.1177/1359105318756500']
831,31617562,Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial.,"Importance


Polypharmacy and inappropriate drug regimens are major health concerns among older adults. Various interventions focused on medication optimization strategies have been carried out, but the effect on patient-relevant outcomes remains uncertain.
Objective


To investigate the effect of clinical geriatric assessments and collaborative medication reviews by geriatrician and family physician (FP) on health-related quality of life and other patient-relevant outcomes in home-dwelling older patients receiving polypharmacy.
Design, Setting, and Participants


Cluster randomized, single-blind, clinical trial. Norwegian FPs were recruited from March 17, 2015, to March 16, 2017, to participate in the trial with their eligible patients. Participants were home-dwelling patients 70 years or older, using at least 7 medications regularly, and having their medications administered by the home nursing service. Patients in the control group received usual care. Randomization occurred at the FP level. A modified intent-to-treat analysis was used.
Intervention


The intervention consisted of 3 main parts: (1) clinical geriatric assessment of the patients combined with a thorough review of their medications; (2) a meeting between the geriatrician and the FP; and (3) clinical follow-up.
Main Outcomes and Measures


The primary outcome was health-related quality of life as assessed by the 15D instrument (score range, 0-1; higher scores indicate better quality of life, with a minimum clinically important change of ±0.015) at week 16. Secondary outcomes included changes in medication appropriateness, physical and cognitive functioning, use of health services, and mortality.
Results


Among 174 patients (mean [SD] age, 83.3 [7.3] years; 67.8% women; 87 randomized to the intervention group and 87 randomized to the control [usual care] group) in 70 FP clusters (36 intervention and 34 control), 158 (90.8%) completed the trial. The mean (SD) 15D instrument score at baseline was 0.708 (0.121) in the intervention group and 0.714 (0.113) in the control group. At week 16, the mean (SD) 15D instrument score was 0.698 (0.164) in the intervention group and 0.655 (0.184) in the control group, with an estimated between-group difference of 0.045 (95% CI, 0.004-0.086; P = .03). Several secondary outcomes were also in favor of the intervention. There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.
Conclusions and Relevance


This study's findings indicate that, among older patients exposed to polypharmacy, clinical geriatric assessments and collaborative medication reviews carried out by a geriatrician in cooperation with the patient's FP can result in positive effects on health-related quality of life.
Trial Registration


ClinicalTrials.gov identifier: NCT02379455.",2020,"There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.
","['Home-Dwelling Older Patients Receiving Polypharmacy', 'older patients', 'older adults', 'Participants were home-dwelling patients 70 years or older, using at least 7 medications regularly, and having their medications administered by the home nursing service', 'home-dwelling older patients receiving polypharmacy', 'Norwegian FPs were recruited from March 17, 2015, to March 16, 2017, to participate in the trial with their eligible patients', '174 patients (mean [SD] age, 83.3 [7.3] years; 67.8% women; 87 randomized to the intervention group and 87 randomized to the control [usual care] group) in 70 FP clusters (36 intervention and 34 control), 158 (90.8%) completed the trial']","['geriatrician and family physician (FP', '3 main parts: (1) clinical geriatric assessment of the patients combined with a thorough review of their medications; (2) a meeting between the geriatrician and the FP; and (3) clinical follow-up', 'usual care', 'Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician']","['changes in medication appropriateness, physical and cognitive functioning, use of health services, and mortality', 'mean (SD) 15D instrument score', 'health-related quality of life as assessed by the 15D instrument (score range, 0-1; higher scores indicate better quality of life']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0019860', 'cui_str': 'Home Care, Nonprofessional'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0586872', 'cui_str': 'Gerontologists'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0017463', 'cui_str': 'Geriatric Assessment'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]",87.0,0.067781,"There were more drug withdrawals, reduced dosages, and new drug regimens started in the intervention group.
","[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Romskaug', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skovlund', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørund', 'Initials': 'J', 'LastName': 'Straand', 'Affiliation': 'Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Molden', 'Affiliation': 'School of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Kersten', 'Affiliation': 'School of Pharmacy, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kaisu H', 'Initials': 'KH', 'LastName': 'Pitkala', 'Affiliation': 'Department of General Practice, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Christofer', 'Initials': 'C', 'LastName': 'Lundqvist', 'Affiliation': 'Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Torgeir B', 'Initials': 'TB', 'LastName': 'Wyller', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5096']
832,31523057,Understanding of prognosis in non-metastatic prostate cancer: a randomised comparative study of clinician estimates measured against the PREDICT prostate prognostic model.,"PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ). In this study clinician estimates of survival were compared against model predictions and its potential value as a clinical tool was assessed. Prostate cancer (PCa) specialists were invited to participate in the study. 190 clinicians (63% urologists, 17% oncologists, 20% other) were randomised into two groups and shown 12 clinical vignettes through an online portal. Each group viewed opposing vignettes with clinical information alone, or alongside PREDICT Prostate estimates. 15-year clinician survival estimates were compared against model predictions and reported treatment recommendations with and without seeing PREDICT estimates were compared. 155 respondents (81.6%) reported counselling new PCa patients at least weekly. Clinician estimates of PCa-specific mortality exceeded PREDICT estimates in 10/12 vignettes. Their estimates for treatment survival benefit at 15 years were over-optimistic in every vignette, with mean clinician estimates more than 5-fold higher than PREDICT Prostate estimates. Concomitantly seeing PREDICT Prostate estimates led to significantly lower reported likelihoods of recommending radical treatment in 7/12 (58%) vignettes, particularly in older patients. These data suggest clinicians overestimate cancer-related mortality and radical treatment benefit. Using an individualised prognostic tool may help reduce overtreatment.",2019,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"['non-metastatic prostate cancer', 'Prostate cancer (PCa) specialists', 'men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ', '190 clinicians (63% urologists, 17% oncologists, 20% other']",[],"['PCa-specific mortality', '15-year clinician survival estimates']","[{'cui': 'C1282496', 'cui_str': 'Metastasis from malignant tumor of prostate'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0260314', 'cui_str': 'Urologists'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]",[],"[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",,0.0282638,PREDICT Prostate is an individualised prognostic model that provides long-term survival estimates for men diagnosed with non-metastatic prostate cancer ( www.prostate.predict.nhs.uk ).,"[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Thurtle', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK. dt433@cam.ac.uk.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Jenkins', 'Affiliation': 'Sussex Health Outcomes Research & Education in Cancer, University of Sussex, Brighton, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, University of Cambridge, Cambridge, UK.'}]",British journal of cancer,['10.1038/s41416-019-0569-4']
833,29730727,"""Healthy Habits, Healthy Girls-Brazil"": an obesity prevention program with added focus on eating disorders.","PURPOSE


To evaluate the immediate post-intervention and 6-month post-intervention effects of a Brazilian school-based randomized controlled trial for girls targeting shared risk factors for obesity and disordered eating.
METHODS


Total of 253 girls, mean of 15.6 (0.05) years from 1st to 3rd grades of high school participated in this 6-month school-based cluster randomized controlled trial. ""Healthy Habits, Healthy Girls-Brazil (H3G-Brazil)"", originally developed in Australia, emphasized 10 key nutrition and physical activity (PA) messages delivered over 6 months. Disordered eating prevention procedures, i.e., prevention of weight-teasing, body satisfaction, and unhealthy weight control behavior, were added to the intervention. Body dissatisfaction, unhealthy weight control behaviors and social cognitive-related diet, and physical activity variables were assessed at baseline, immediate post-intervention, and 6-month post-intervention. Intervention effects were determined by one-way analysis of covariance or logistic regression, after checking for the clustering effects of school. The control group did not receive intervention prior to follow-up assessment. A conservative significance level was set at p < 0.01.
RESULTS


Beneficial effects were detected for PA social support (F = 6.005, p = 0.01), and healthy eating strategies (F = 6.08, p = 0.01) immediate post-intervention; and healthy eating social support (F = 14.731, p = 0.00) and healthy eating strategies (F = 5.812, p = 0.01) at 6-month post-intervention. Intervention group was more likely to report unhealthy weight control behaviors (OR = 1.92, 95% CI 1.15-3.21, p = 0.01) at 6-month post-intervention. No other significant immediate or 6-month post effects were detected.
CONCLUSION


H3G-Brazil demonstrated positive 6-month effects on some social cognitive variables but an adverse effect on unhealthy weight control behaviors. Thus, this study was not able to achieve synergy by combining obesity and disordered eating prevention procedures in an intervention among low-income girls in Brazil.
TRIAL REGISTRATION


Level I: cluster randomized controlled trial.",2019,"RESULTS


Beneficial effects were detected for PA social support (F = 6.005, p = 0.01), and healthy eating strategies (F = 6.08, p = 0.01) immediate post-intervention; and healthy eating social support (F = 14.731, p = 0.00) and healthy eating strategies (F = 5.812, p = 0.01) at 6-month post-intervention.","['girls targeting shared risk factors for obesity and disordered eating', 'low-income girls in Brazil', 'Healthy Habits, Healthy Girls-Brazil (H3G-Brazil)"", originally developed in Australia', 'Total of 253 girls, mean of 15.6 (0.05) years from 1st to 3rd grades of high school participated in this 6-month school-based cluster randomized controlled trial. ']",[],"['weight-teasing, body satisfaction, and unhealthy weight control behavior', 'healthy eating strategies', 'unhealthy weight control behaviors', 'healthy eating social support', 'social cognitive variables', 'PA social support', 'Body dissatisfaction, unhealthy weight control behaviors and social cognitive-related diet, and physical activity variables']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0037438'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",253.0,0.0516977,"RESULTS


Beneficial effects were detected for PA social support (F = 6.005, p = 0.01), and healthy eating strategies (F = 6.08, p = 0.01) immediate post-intervention; and healthy eating social support (F = 14.731, p = 0.00) and healthy eating strategies (F = 5.812, p = 0.01) at 6-month post-intervention.","[{'ForeName': 'Ana Carolina Barco', 'Initials': 'ACB', 'LastName': 'Leme', 'Affiliation': ""Children's Nutrition Research Center, Baylor College of Medicine, Houston, USA. acarol.leme@gmail.com.""}, {'ForeName': 'Sonia Tucunduva', 'Initials': 'ST', 'LastName': 'Philippi', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""Children's Nutrition Research Center, Baylor College of Medicine, Houston, USA.""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Nicklas', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': 'Department of Nutrition, School of Public Health, University of São Paulo, São Paulo, Brazil.'}]",Eating and weight disorders : EWD,['10.1007/s40519-018-0510-5']
834,31450541,Assessment of radiation dose and iodine load reduction in head-neck CT angiography using two scan protocols with wide-detector.,"OBJECTIVE


To compare image quality, radiation dose, and iodine intake of head-neck CT angiography (CTA) acquired by wide-detector with the gemstone spectral imaging (GSI) combination with low iodine intake or routine scan protocol.
METHODS


Three hundred patients who had head-neck CTA were enrolled and divided into three groups according to their BMI values: group A (18.5 kg/m2 ≦ BMI <24.9 kg/m2), group B (24.9 kg/m2 ≦ BMI <29.9 kg/m2) and group C (29.9 kg/m2 ≦ BMI ≦ 34.9 kg/m2) with 100 patients in each group. Patients in each group were randomly divided into two subgroups (n = 50) namely, A1, A2, B1, B2, C1 and C2. The patients in subgroups A1, B1 and C1 underwent GSI with low iodine intake (270 mgI/ml, 50 ml) and combined with the ASiR-V algorithm. Other patients underwent three dimensional (3D) smart mA modulation with routine iodine intake (350 mgI/ml, 60 ml). Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of all images were calculated after angiography. Images were then subjectively assessed using a 5-point scale. CT dose index of volume and dose-length product (DLP) was converted to the effective dose (ED) and then compared.
RESULTS


The mean CT values, SNR, CNR and subjective image quality in subgroups A2, B2 and C2 are significantly lower than in subgroups A1, B1, and C1 (P < 0.01), respectively. The ED values in subgroup A1, B1, and C1 are 55.18%, 61.89%, and 69.64% lower than those in A2, B2, and C2, respectively (P < 0.01). The total iodine intakes in subgroups A1, B1, and C1 are 35.72% lower than those in subgroups A2, B2, and C2.
CONCLUSIONS


The gemstone spectral imaging with monochromatic images at 53-57 keV combined with ASiR-V algorithm allows significant reduction in iodine load and radiation dose in head-neck CT angiography than those yielded in routine scan protocol. It also enhances signal intensity of head-neck CTA and maintains image quality.",2019,"The mean CT values, SNR, CNR and subjective image quality in subgroups A2, B2 and C2 are significantly lower than in subgroups A1, B1, and C1 (P < 0.01), respectively.",['Three hundred patients who had head-neck CTA'],"['GSI with low iodine intake', 'iodine intake of head-neck CT angiography (CTA) acquired by wide-detector with the gemstone spectral imaging (GSI) combination with low iodine intake', 'three dimensional (3D) smart mA modulation with routine iodine intake']","['total iodine intakes', 'CT dose index of volume and dose-length product (DLP', 'mean CT values, SNR, CNR and subjective image quality', 'Signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",300.0,0.0175663,"The mean CT values, SNR, CNR and subjective image quality in subgroups A2, B2 and C2 are significantly lower than in subgroups A1, B1, and C1 (P < 0.01), respectively.","[{'ForeName': 'Yongxia', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Geng', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Tianle', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Xiuzhi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Yize', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Dong', 'Affiliation': 'College of Medicine, Hebei University, Baoding, China.'}]",Journal of X-ray science and technology,['10.3233/XST-190541']
835,31518224,A Pilot Study of Exenatide Actions in Alzheimer's Disease.,"BACKGROUND


Strong preclinical evidence suggests that exenatide, a glucagon-like peptide-1 (GLP- 1) receptor agonist used for treating type 2 diabetes, is neuroprotective and disease-modifying in Alzheimer's Disease (AD).
OBJECTIVE


We performed an 18-month double-blind randomized placebo-controlled Phase II clinical trial to assess the safety and tolerability of exenatide and explore treatment responses for clinical, cognitive, and biomarker outcomes in early AD.
METHOD


Eighteen participants with high probability AD based on cerebrospinal fluid (CSF) biomarkers completed the entire study prior to its early termination by the sponsor; partial outcomes were available for twentyone.
RESULTS


Exenatide was safe and well-tolerated, showing an expectedly higher incidence of nausea and decreased appetite compared to placebo and decreasing glucose and GLP-1 during Oral Glucose Tolerance Tests. Exenatide treatment produced no differences or trends compared to placebo for clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV) except for a reduction of Aβ42 in EVs.
CONCLUSION


The positive finding of lower EV Aβ42 supports emerging evidence that plasma neuronal EVs provide an effective platform for demonstrating biomarker responses in clinical trials in AD. The study was underpowered due to early termination and therefore we cannot draw any firm conclusions. However, the analysis of secondary outcomes shows no trends in support of the hypothesis that exenatide is diseasemodifying in clinical AD, and lowering EV Aβ42 in and of itself may not improve cognitive outcomes in AD.",2019,"Exenatide treatment produced no differences or trends compared to placebo for clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV) except for a reduction of Aβ42 in EVs.
","[""Alzheimer's disease"", 'Eighteen participants with high probability AD based on cerebrospinal fluid (CSF) biomarkers completed the entire study prior to its early termination by the sponsor; partial outcomes were available for twenty-one', 'early AD']","['placebo', 'Exenatide', 'exenatide', 'exenatide actions']","['clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV', 'nausea and decreased appetite', 'safety and tolerability', 'safe and well-tolerated']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0007807'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",18.0,0.226788,"Exenatide treatment produced no differences or trends compared to placebo for clinical and cognitive measures, MRI cortical thickness and volume, or biomarkers in CSF, plasma, and plasma neuronal extracellular vesicles (EV) except for a reduction of Aβ42 in EVs.
","[{'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Mullins', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Mustapic', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Chee W', 'Initials': 'CW', 'LastName': 'Chia', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Carlson', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulyani', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tran', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Yazhou', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Translational Gerontology Branch, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Mattson', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Resnick', 'Affiliation': 'Laboratory of Behavioral Neuroscience, Intramural Research Program, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Josephine M', 'Initials': 'JM', 'LastName': 'Egan', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Nigel H', 'Initials': 'NH', 'LastName': 'Greig', 'Affiliation': 'Translational Gerontology Branch, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kapogiannis', 'Affiliation': 'Laboratory of Neurosciences, National Institute on Aging/National Institutes of Health (NIA/NIH), 3001 S. Hanover St, NM531, Baltimore, MD, 21225, United States.'}]",Current Alzheimer research,['10.2174/1567205016666190913155950']
836,31608373,The Effect of Community-Based Nutritional Interventions on Children of Women Living With Human Immunodeficiency Virus in Rural India: A 2 × 2 Factorial Intervention Trial.,"BACKGROUND


Malnutrition is a common clinical concern among children in low-income communities affected by human immunodeficiency virus (HIV). We examined the effect of a community-based nutritional intervention on anthropometric and clinical outcomes of children of women living with HIV in rural India.
METHODS


We assigned women living with HIV and their child (oldest 3-8 years) to 1 of 4 programs: (1) community-based HIV care program, (2) program 1 + nutrition education, (3) program 1 + food supplement, and (4) all elements of programs 1-3. Study data were collected at baseline and months 6, 12, and 18. We applied mixed-effects modeling with restricted maximum likelihood estimation to examine changes in weight (all children) and CD4+ T-cell counts (children with HIV only).
RESULTS


Overall, 600 mother-child pairs were enrolled (150/group) with 100% retention at follow-up visits. Approximately 20% of children were living with HIV. Children in program 4 had higher weight gain than those in programs 1, 2, and 3 at all time points (adjusted P < .001). We found a higher increase in CD4+ T cells across all time points among participants in programs 3 and 4 compared with program 1 (adjusted P < .001). Factorial analysis suggested a synergistic effect of combining nutrition education and food supplements for weight gain but not for increase in CD4+ T cells.
CONCLUSIONS


A combination of nutrition education and food supplements provided to women living with HIV significantly increased weight and CD4+ T cells, and such interventions can be integrated into HIV-care programs in low-income settings.",2020,"Children in Program 4 had higher weight gain compared to Programs 1, 2 and 3 at all time points (adjusted p < 0.001).","['children of women living with HIV in rural India', 'women living with HIV and their child (oldest 3-8 years) to one of the four programs: 1', '600 mother-child pairs were enrolled (150 per group) with 100% retention at follow-up visits', 'women living with HIV']","['community-based nutritional interventions', 'nutrition education and food supplements', 'community-based nutritional intervention', 'community-based HIV care program']","['CD4+ T cells', 'weight and CD4+ T cells', 'weight gain']","[{'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",600.0,0.0719227,"Children in Program 4 had higher weight gain compared to Programs 1, 2 and 3 at all time points (adjusted p < 0.001).","[{'ForeName': 'Sanghyuk S', 'Initials': 'SS', 'LastName': 'Shin', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Veena A', 'Initials': 'VA', 'LastName': 'Satyanarayana', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neurosciences, Bengaluru, India.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Carpenter', 'Affiliation': 'Department of Epidemiology, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Pamujula', 'Affiliation': 'A.C. Subba Reddy Government Medical College, Nellore, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Medicine, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Adeline M', 'Initials': 'AM', 'LastName': 'Nyamathi', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California Irvine, Irvine, California, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1009']
837,31634877,"Medication Management Program: Adherence, Disease-related Knowledge, Health-related Quality of Life, and Glycemic Control for Type 2 Diabetes Mellitus.","Context


Escalation in rates of diabetes in Pakistan is posing threats to the economy and to the people's quality of life due to poor glycemic control and very high rates of complications. Cost of care is very high, and many barriers to quality care exist. Most often patients are unable to afford the high cost of treatment. Patients' knowledge about diabetes is associated with better medication adherence and better glycemic control.
Objective


The current study intended to evaluate the effects of an educational intervention in a pharmacist led, medication management program (MTM) tailored for patients with type 2 diabetes (T2DM).
Design


The research team conducted a nonclinical, randomized controlled trial.
Setting


The study took place at District Headquarters and Teaching Hospital, a public-sector hospital (Sargodha, Pakistan).
Participants


Participants were 392 individuals with T2DM.
Intervention


Participants were randomly assigned to one of 2 groups-intervention and control-with 196 patients in each. The intervention group, instead of receiving standard care, received pharmaceutical care through the Medication Therapy Management program, whereas the control group received standard care.
Outcome Measures


At baseline and 3 mo post ntervention, the study assessed participants' diabetes-related knowledge, medication adherence, and health-related quality of life (HRQoL) using the 14-item Michigan Diabetes Knowledge Test, the 8-item Morisky Medication Adherence Scale, and the European Quality of Life scales, respectively. To determine glycemic control, participants' baseline HbA1c levels were taken from their medical records, and the final HbA1c result was obtained postintervention.
Results


For the intervention and control groups at baseline, diabetes-related knowledge was average, at 7.99 ± 2.65 and 8.03 ± 2.49, respectively; medication adherence was low, at 4.54 ± 1.69 and 4.41 ± 1.84, respectively; and glycemic control was poor, at 9.47 ± 1.57 and 9.41 ± 1.57, respectively. After the educational intervention, the intervention group had increased its diabetes-related knowledge, medication adherence, and HRQoL scores, with the results being 10.55 ± 2.56, 5.24 ± 1.48, and 0.6115 ± 0.286, respectively. The group's glycemic control has also improved to 8.97 ± 1.362. A statistically significant difference between the groups had occurred, with P < .001. The control group's scores had remained approximately the same for medication adherence, HRQoL, and glycemic control, and little difference had occurred as compared with the group's baseline analysis.
Conclusion


The study found that the educational program increased the intervention group's level of diabetes-related knowledge, and improved its adherence to medication and its glycemic control, all due to its improved HRQoL. Patients' beliefs about the effects of long-term use of medicines were also addressed by the MTM program. The program was successful because it decreased participants' HbA1c values, which is a positive indicator of successful T2DM therapy.",2020,"After the educational intervention, the intervention group had increased its diabetes-related knowledge, medication adherence, and HRQoL scores, with the results being 10.55 ± 2.56, 5.24 ± 1.48, and 0.6115 ± 0.286, respectively.","['Setting\n\n\nThe study took place at District Headquarters and Teaching Hospital, a public-sector hospital (Sargodha, Pakistan', 'patients with type 2 diabetes (T2DM', 'Participants\n\n\nParticipants were 392 individuals with T2DM']","['receiving standard care, received pharmaceutical care through the Medication Therapy Management program, whereas the control group received standard care', 'medication management program (MTM', 'educational intervention', 'Medication Management Program']","['medication adherence', 'diabetes-related knowledge, medication adherence, and HRQoL scores', 'Adherence, Disease-related Knowledge, Health-related Quality of Life, and Glycemic Control', 'glycemic control', 'diabetes-related knowledge, medication adherence, and health-related quality of life (HRQoL) using the 14-item Michigan Diabetes Knowledge Test, the 8-item Morisky Medication Adherence Scale, and the European Quality of Life scales', 'medication adherence, HRQoL, and glycemic control']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}]",392.0,0.026022,"After the educational intervention, the intervention group had increased its diabetes-related knowledge, medication adherence, and HRQoL scores, with the results being 10.55 ± 2.56, 5.24 ± 1.48, and 0.6115 ± 0.286, respectively.","[{'ForeName': 'Saeed Ur Rashid', 'Initials': 'SUR', 'LastName': 'Nazir', 'Affiliation': ''}, {'ForeName': 'Mohamed Azmi', 'Initials': 'MA', 'LastName': 'Hassali', 'Affiliation': ''}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Saleem', 'Affiliation': ''}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Haque', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
838,29522138,"Pacritinib vs Best Available Therapy, Including Ruxolitinib, in Patients With Myelofibrosis: A Randomized Clinical Trial.","Importance


Myelofibrosis is a hematologic malignancy characterized by splenomegaly and debilitating symptoms. Thrombocytopenia is a poor prognostic feature and limits use of Janus kinase 1 (JAK1)/Janus kinase 2 (JAK2) inhibitor ruxolitinib.
Objective


To compare the efficacy and safety of JAK2 inhibitor pacritinib with that of best available therapy (BAT), including ruxolitinib, in patients with myelofibrosis and thrombocytopenia.
Design, Setting, and Participants


For this phase 3 randomized international multicenter study-the PERSIST-2 study-of pacritinib vs BAT, 311 patients with myelofibrosis and platelet count 100 × 109/L or less were recruited for analysis. Crossover from BAT was allowed after week 24 or for progression of splenomegaly.
Interventions


Patients were randomized 1:1:1 to pacritinib 400 mg once daily, pacritinib 200 mg twice daily, or BAT.
Main Outcomes and Measures


Coprimary end points were rates of patients achieving 35% or more spleen volume reduction (SVR) and 50% or more reduction in total symptom score (TSS) at week 24. Efficacy analyses were performed on the intention-to-treat efficacy population, comprising all patients with a randomization date allowing for week 24 data.
Results


Overall, 311 patients (mean [SD] age, 63.70 [9.08] years; 171 men [55%] and 140 women [45%]) were included in the study; 149 patients (48%) had prior ruxolitinib. The most common BAT was ruxolitinib (44 patients [45%]); 19 patients (19%) received watchful-waiting only. The intention-to-treat efficacy population included 75 patients randomized to pacritinib once daily; 74, pacritinib twice daily, and 72, BAT. Pacritinib (arms combined) was more effective than BAT for 35% or more SVR (27 patients [18%] vs 2 patients [3%]; P = .001) and had a nonsignificantly greater rate of 50% or more reduction in TSS (37 patients [25%] vs 10 patients [14%]; P = .08). Pacritinib twice daily led to significant improvements in both end points over BAT (≥35% SVR: 16 patients [22%] vs 2 patients [3%]; P = .001; ≥50% reduction in TSS: 24 patients [32%] vs 10 patients [14%]; P = .01). Clinical improvement in hemoglobin and reduction in transfusion burden were greatest with pacritinib twice daily. For pacritinib once daily, pacritinib twice daily, and BAT, the most common (>10%) grade 3 or 4 adverse events were thrombocytopenia (32 patients [31%], 34 patients [32%], 18 patients [18%]), and anemia (28 patients [27%], 23 patients [22%], 14 patients [14%]). In the pacritinib once daily, twice daily, and BAT arms, discontinuation owing to adverse events occurred in 15 patients (14%), 10 patients (9%), and 4 patients (4%).
Conclusions and Relevance


In patients with myelofibrosis and thrombocytopenia, including those with prior anti-JAK therapy, pacritinib twice daily was more effective than BAT, including ruxolitinib, for reducing splenomegaly and symptoms.
Trial Registration


clinicaltrials.gov Identifier: NCT02055781.",2018,Pacritinib twice daily led to significant improvements in both end points over BAT (≥35% SVR: 16 patients [22%] vs 2 patients [3%]; P = .001; ≥50% reduction in TSS: 24 patients [32%] vs 10 patients [14%]; P = .01).,"['311 patients (mean [SD] age, 63.70', 'patients with myelofibrosis and thrombocytopenia', '311 patients with myelofibrosis and platelet count 100\u2009×\u2009109/L or less were recruited for analysis', '9.08] years; 171 men [55%] and 140 women [45%]) were included in the study; 149 patients (48%) had prior ruxolitinib', 'Patients With Myelofibrosis']","['pacritinib 400 mg once daily, pacritinib 200 mg twice daily, or BAT', 'JAK2 inhibitor pacritinib', 'pacritinib vs BAT', 'BAT', 'TSS']","['Thrombocytopenia', 'hemoglobin and reduction in transfusion burden', 'adverse events', 'rates of patients achieving 35% or more spleen volume reduction (SVR', 'total symptom score (TSS', 'anemia', 'thrombocytopenia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001815', 'cui_str': 'Idiopathic Myelofibrosis'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2931926', 'cui_str': 'ruxolitinib'}]","[{'cui': 'C3467842'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0008139', 'cui_str': 'Bats'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037993', 'cui_str': 'Spleen'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",311.0,0.0778592,Pacritinib twice daily led to significant improvements in both end points over BAT (≥35% SVR: 16 patients [22%] vs 2 patients [3%]; P = .001; ≥50% reduction in TSS: 24 patients [32%] vs 10 patients [14%]; P = .01).,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mascarenhas', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Talpaz', 'Affiliation': 'University of Michigan, Comprehensive Cancer Center, Ann Arbor.'}, {'ForeName': 'Aaron T', 'Initials': 'AT', 'LastName': 'Gerds', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Princess Margaret Cancer Center, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Szoke', 'Affiliation': 'Albert Szent-Györgyi Clinical Center, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drummond', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pristupa', 'Affiliation': ""Ryazan's Clinical Hospital, Ryazan, Russia.""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Granston', 'Affiliation': 'CTI BioPharma Corp, Seattle, Washington.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Daly', 'Affiliation': 'CTI BioPharma Corp, Seattle, Washington.'}, {'ForeName': 'Suliman', 'Initials': 'S', 'LastName': 'Al-Fayoumi', 'Affiliation': 'CTI BioPharma Corp, Seattle, Washington.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Callahan', 'Affiliation': 'CTI BioPharma Corp, Seattle, Washington.'}, {'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Singer', 'Affiliation': 'CTI BioPharma Corp, Seattle, Washington.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gotlib', 'Affiliation': 'Stanford University School of Medicine/Stanford Cancer Institute, Stanford, California.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Jamieson', 'Affiliation': 'University of California-San Diego, La Jolla.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Harrison', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, England.""}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Mesa', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}]",JAMA oncology,['10.1001/jamaoncol.2017.5818']
839,29519156,The effect of attentional bias modification training on food intake in overweight and obese women.,"This study modified food attentional biases via computerized attentional bias modification training and examined the effects on food intake. Overweight women were randomly allocated to (1) direct attention away from food (""attentional-training""), (2) direct attention at random to food or neutral (""placebo""), or (3) no training (""control""). Individuals then completed a taste test. Those in the attentional-training consumed on average 600 kJ less of total food compared to the placebo. Those in the attentional-training had a reduction in food attentional bias compared to the placebo group, when controlling for executive function. Attentional-training seems to reduce high-calorie intake in overweight women.",2020,"Those in the attentional-training had a reduction in food attentional bias compared to the placebo group, when controlling for executive function.","['Overweight women', 'overweight and obese women', 'overweight women']","['computerized attentional bias modification training', 'Attentional-training', 'placebo', 'attentional bias modification training', 'direct attention away from food (""attentional-training""), (2) direct attention at random to food or neutral (""placebo""), or (3) no training (""control']",['food attentional bias'],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0566193', 'cui_str': 'Does direct attention (finding)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}]",,0.0335096,"Those in the attentional-training had a reduction in food attentional bias compared to the placebo group, when controlling for executive function.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Agatha', 'Initials': 'A', 'LastName': 'Treffiletti', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Phoebe E', 'Initials': 'PE', 'LastName': 'Bailey', 'Affiliation': 'Western Sydney University, Australia.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Moustafa', 'Affiliation': 'Western Sydney University, Australia.'}]",Journal of health psychology,['10.1177/1359105318758856']
840,30445572,The effects of low suction on digital drainage devices after lobectomy using video-assisted thoracoscopic surgery: a randomized controlled trial†.,"OBJECTIVES


The optimal level of suction on digital chest drainage devices after lobectomy using video-assisted thoracoscopic surgery (VATS) is unknown and varies between thoracic centres. In this randomized controlled trial, we assessed the potential benefits of low suction of -2 cmH2O compared to -10 cmH2O, using a digital drainage device.
METHODS


Two hundred and twenty-eight patients were randomized into 2 groups after VATS lobectomy for suspected or confirmed lung cancer. Primary outcome was time to chest drain removal. Drain data were obtained from the digital drainage devices, and patient data were obtained from medical records during admission, with a follow-up until postoperative day 30.
RESULTS


For the -2 cmH2O and -10 cmH2O groups, median (interquartile range) drainage duration was 27.4 h (23.3-71.2) and 47.5 h (24.5-117.8) (P = 0.047), and the incidence of prolonged air leak >5 days was 14.4% and 24.3% (P = 0.089), respectively. Median total fluid production was 566 h (329-1155) ml and 795 h (454-1605) ml (P = 0.007). Median time to consistent air leak cessation (<20 ml/min) was 5.2 h (0.3-34.2) and 23.7 h (0.8-90.8) (P < 0.001). There were no differences in the proportion or the size of the pneumothorax or subcutaneous emphysema after drain removal, and no differences were observed in postoperative morbidity. Median length of in-hospital stay was 2.0 days (2.0-5.8) and 3.0 days (2.0-9.0) (P = 0.18).
CONCLUSIONS


A low suction level significantly shortened drainage duration, time to air leak cessation and total fluid production, without increasing morbidity.
CLINICAL TRIAL REGISTRATION NUMBER


NCT02911259.",2019,"CONCLUSIONS


A low suction level significantly shortened drainage duration, time to air leak cessation and total fluid production, without increasing morbidity.
",['Two hundred and twenty-eight patients'],"['low suction', 'video-assisted thoracoscopic surgery (VATS', 'lobectomy using video-assisted thoracoscopic surgery', 'VATS lobectomy', 'low suction of -2 cmH2O compared to -10 cmH2O']","['postoperative morbidity', 'Median total fluid production', 'digital drainage devices', 'drainage duration, time to air leak cessation and total fluid production', 'time to chest drain removal', 'Median time to consistent air leak cessation', 'incidence of prolonged air leak', 'Median length of in-hospital stay', 'proportion or the size of the pneumothorax or subcutaneous emphysema', 'median (interquartile range) drainage duration']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland (procedure)'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0033268'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking (qualifier value)'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0038536', 'cui_str': 'Subcutaneous Emphysema'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",228.0,0.417699,"CONCLUSIONS


A low suction level significantly shortened drainage duration, time to air leak cessation and total fluid production, without increasing morbidity.
","[{'ForeName': 'Bo Laksáfoss', 'Initials': 'BL', 'LastName': 'Holbek', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Jessen', 'Initials': 'HJ', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Unit of Surgical Pathophysiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'René Horsleben', 'Initials': 'RH', 'LastName': 'Petersen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery,['10.1093/ejcts/ezy361']
841,29369834,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise -Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2018,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Twenty race finishers with mild to moderately symptomatic EAH', 'Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada']","['Oral Hypertonic Saline', 'oral HTS', 'HTS', 'sealed envelopes, containing the word either ""oral"" or ""IV', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
842,31617048,Adherence to behavioral recommendations for weight loss and associated psychosocial factors among African American adults.,"PURPOSE


To identify patterns of behavioral adherence among 388 African Americans who participated in the Weight Loss Maintenance trial and examine associated psychosocial factors.
METHODS


Using repeated measures latent class analysis, we modeled patterns of adherence to recommendations regarding fruit and vegetable, total fat, and saturated fat intake and physical activity at baseline, 6, and 18 months. Latent classes were compared on the SF-36 (mental health composite and vitality subscale), Perceived Stress Scale, and PHQ-8 at each time point.
RESULTS


Three distinct latent classes emerged: Nutrition Adherers (n = 96); Physical Activity Adherers (n = 61); and Non-Adherers (n = 231). All groups showed initial improvement in psychosocial measures followed by relapse. Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months.
CONCLUSION


Psychological well-being should be addressed with African Americans in weight loss treatment to enhance behavior change and improve weight loss outcomes.",2020,"Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months.
","['388 African Americans who participated in the Weight Loss Maintenance trial and examine associated psychosocial factors', 'African American adults']",[],"['Nutrition Adherers', 'mean mental health and vitality scores and higher depression scores', 'weight loss outcomes', 'SF-36 (mental health composite and vitality subscale), Perceived Stress Scale, and PHQ-8 at each time point', 'Physical Activity Adherers', 'adherence to recommendations regarding fruit and vegetable, total fat, and saturated fat intake and physical activity', 'psychosocial measures']","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0556120', 'cui_str': 'Saturated fat intake (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",388.0,0.0180087,"Non-Adherers had significantly lower mean mental health and vitality scores and higher depression scores than adherers at 6 and 18 months.
","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Fitzpatrick', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA. Stephanie.L.Fitzpatrick@kpchr.org.'}, {'ForeName': 'Neon', 'Initials': 'N', 'LastName': 'Brooks', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Bray', 'Affiliation': 'The Methodology Center, Penn State University, State College, PA, USA.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Stevens', 'Affiliation': 'Kaiser Permanente Center for Health Research, 3800 N. Interstate Ave, Portland, OR, 97227, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00108-2']
843,29630433,Prospective evaluation of relationships between radiotherapy dose to masticatory apparatus and trismus.,"AIMS


This feasibility study aimed to identify relationships between radiation doses to the masticatory apparatus as a combined block or as individual subunits with changes in trismus following radiotherapy.
MATERIAL AND METHODS


Twenty patients from a single center were recruited prospectively as part of a randomized trial comparing proactive exercises in the management of trismus. Patients with stage III/IV oral cavity or oropharyngeal squamous cell cancers received intensity-modulated radiotherapy with concurrent systemic therapy. All patients had trismus prior to radiotherapy. Maximal inter-incisor distance (MID) was measured pre- and 6 months from the start of radiotherapy. Bilateral muscles of mastication: medial and lateral pterygoids (MP and LP), masseters (M), temporalis (T), temporomandibular joint (TMJ) were contoured on CT images. The block comprised all muscles excluding the TMJ below the orbital floor. Mean dose, equivalent uniform dose (EUD) and V35-V60 Gy were compared with change in MID.
RESULTS


In six patients, the MID deteriorated at 6 months from the start of radiotherapy compared with 14 whose MID improved. No significant association was observed between age, gender, smoking, alcohol status, exercise compliance, cisplatin, tumor site, stage, V35-V60 Gy or EUD with change in MID. A clinical outlier was excluded. Without the outlier (n = 19), a significant association was seen between mean dose and change in MID at 6 months for the ipsilateral block (p = .01), LP (p = .04) and M (p < .01). All patients where trismus deteriorated at 6 months received mean doses >40 Gy to the block.
CONCLUSION


Higher mean radiation doses to the ipsilateral block, LP and M were significantly associated with deterioration in trismus. Limiting dose to these structures to ≤40 Gy for tumors not invading the masticatory muscles may improve treatment-related sequelae. The ipsilateral block, LP and M should be studied further as possible alternative avoidance structures in radiotherapy treatment planning.",2018,"Higher mean radiation doses to the ipsilateral block, LP and M were significantly associated with deterioration in trismus.","['Patients with stage III/IV oral cavity or oropharyngeal squamous cell cancers', 'Twenty patients from a single center']","['intensity-modulated radiotherapy with concurrent systemic therapy', 'proactive exercises', 'radiotherapy']","['MID deteriorated', 'Maximal inter-incisor distance (MID', 'Bilateral muscles of mastication: medial and lateral pterygoids (MP and LP), masseters (M), temporalis (T), temporomandibular joint (TMJ', 'age, gender, smoking, alcohol status, exercise compliance, cisplatin, tumor site, stage, V35-V60\u2009Gy or EUD with change in MID', 'Mean dose, equivalent uniform dose (EUD) and V35-V60\u2009Gy', 'mean dose and change in MID']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0751688', 'cui_str': 'Squamous Cell Cancer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0024890', 'cui_str': 'Masticatory muscles'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0475445', 'cui_str': 'Tumor site'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4019284', 'cui_str': 'Uniforms'}]",20.0,0.0320996,"Higher mean radiation doses to the ipsilateral block, LP and M were significantly associated with deterioration in trismus.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Hague', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Beasley', 'Affiliation': 'b Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Heath , University of Manchester, Manchester Academic Health Science Centre , Manchester , UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Garcez', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'Lip W', 'Initials': 'LW', 'LastName': 'Lee', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McPartlin', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'McWilliam', 'Affiliation': 'b Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Heath , University of Manchester, Manchester Academic Health Science Centre , Manchester , UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ryder', 'Affiliation': 'd Statistics Unit , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Sykes', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thomson', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'van Herk', 'Affiliation': 'b Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Heath , University of Manchester, Manchester Academic Health Science Centre , Manchester , UK.'}, {'ForeName': 'Catharine', 'Initials': 'C', 'LastName': 'West', 'Affiliation': 'e Translational Radiobiology Group, Division of Cancer Sciences , Manchester Academic Health Science Centre, University of Manchester, The Christie NHS Foundation Trust , Manchester , UK.'}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Slevin', 'Affiliation': 'a Department of Head and Neck Clinical Oncology , The Christie NHS Foundation Trust , Manchester , UK.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2018.1459047']
844,29642095,"Efficacy of Intra-articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2018,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['Knee Osteoarthritis', '100 patients']","['HA [PNs associated with HA (PNHA', 'Hyaluronic acid (HA', 'PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone']","['Knee Society Score total score and pain item', 'knee function and pain', 'adverse events', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
845,29602860,Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study.,"INTRODUCTION


Patients can develop trismus from their head and neck cancer or as a result of treatment. Trismus affects the jaw muscles and makes mouth opening difficult. To potentially combat trismus, patients could undertake proactive jaw stretching exercises prior to, during and after radiotherapy, although currently these are not the standard of care.
METHODS AND ANALYSIS


This is a randomised, open-label, controlled, two-centre feasibility study, to assess the objective and subjective effectiveness and cost-effectiveness of therabite use compared with wooden spatula in ameliorating trismus in patients treated for stage 3 and 4 oral and oropharyngeal cancer, managed either by primary surgery followed by (chemo)radiotherapy or primary (chemo)radiotherapy. The principal objective assessment is measurement of maximum jaw opening. Assessments in all cases will be performed preradiotherapy and again at 3 and 6 months postintervention.Secondary aims of the study will be (1) to assess whether therabite or the wooden spatula intervention improves patients' quality of life, (2) reduce the level of post-treatment clinical management/healthcare use and (3) a nested qualitative study will explore the experience of the patient taking part in the intervention; data will be transcribed verbatim and analysis will be based on content analysis methods using the interview questions as the framework for examination.
ETHICS AND DISSEMINATION


North West Greater Manchester granted ethical approval (REC Reference 11/NW/0744). Good Clinical Practice and the Declaration of Helsinki have been adhered to. The results will be presented internationally and submitted to a peer-reviewed journal. Head and neck cancer charities and information websites will also be approached.
TRIAL REGISTRATION NUMBER


NCT01733797.",2018,"Secondary aims of the study will be (1) to assess whether therabite or the wooden spatula intervention improves patients' quality of life, (2) reduce the level of post-treatment clinical management/healthcare use and (3) a nested qualitative study will explore the experience of the patient taking part in the intervention; data will be transcribed verbatim and analysis will be based on content analysis methods using the interview questions as the framework for examination.
","['patients treated for stage 3 and 4 oral and oropharyngeal cancer, managed either by primary surgery followed by (chemo)radiotherapy or primary (chemo)radiotherapy', 'patients with head and neck cancer']","['wooden spatula intervention', 'wooden spatula']",['amelioration of trismus'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0557859', 'cui_str': 'Wooden (qualifier value)'}]","[{'cui': 'C0041105', 'cui_str': 'Trismus'}]",,0.0971398,"Secondary aims of the study will be (1) to assess whether therabite or the wooden spatula intervention improves patients' quality of life, (2) reduce the level of post-treatment clinical management/healthcare use and (3) a nested qualitative study will explore the experience of the patient taking part in the intervention; data will be transcribed verbatim and analysis will be based on content analysis methods using the interview questions as the framework for examination.
","[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Oncology, The Christie NHS Foundation Trust Hospital, Manchester, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Molassiotis', 'Affiliation': 'The School of Nursing, Hong Kong Polytechnic University, China, Hong Kong.'}, {'ForeName': 'Simon N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Evidence-Based Practice Research Centre (EPRC), Edge Hill University, Liverpool, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ryder', 'Affiliation': 'Clinical Trials Unit, The Christie NHS Foundation Trust Hospital, Manchester, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Slevin', 'Affiliation': 'Department of Clinical Oncology, The Christie NHS Foundation Trust Hospital, Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2018-021938']
846,29505772,"Effect of ibuprofen vs acetaminophen on postpartum hypertension in preeclampsia with severe features: a double-masked, randomized controlled trial.","BACKGROUND


Nonsteroidal antiinflammatory drug use has been shown to increase blood pressure in nonpregnant adults. Because of this, the American College of Obstetricians and Gynecologists suggests avoiding their use in women with postpartum hypertension; however, evidence to support this recommendation is lacking.
OBJECTIVE


Our goal was to test the hypothesis that nonsteroidal antiinflammatory drugs, such as ibuprofen, adversely affect postpartum blood pressure control in women with preeclampsia with severe features.
STUDY DESIGN


At delivery, we randomized women with preeclampsia with severe features to receive around-the-clock oral dosing with either 600 mg of ibuprofen or 650 mg of acetaminophen every 6 hours. Dosing began within 6 hours after delivery and continued until discharge, with opioid analgesics available as needed for breakthrough pain. Study drugs were encapsulated in identical capsules such that patients, nurses, and physicians were masked to study allocation. Exclusion criteria were serum aspartate aminotransferase or alanine aminotransferase >200 mg/dL, serum creatinine >1.0 mg/dL, infectious hepatitis, gastroesophageal reflux disease, age <18 years, or current incarceration. Our primary outcome was the duration of severe-range hypertension, defined as the time (in hours) from delivery to the last blood pressure ≥160/110 mm Hg. Secondary outcomes were time from delivery to last blood pressure ≥150/100 mm Hg, mean arterial pressure, need for antihypertensive medication at discharge, prolongation of hospital stay for blood pressure control, postpartum use of short-acting antihypertensives for acute blood pressure control, and opioid use for breakthrough pain. We analyzed all outcome data according to intention-to-treat principles.
RESULTS


We assessed 154 women for eligibility, of whom 100 met entry criteria, agreed to participate, and were randomized to receive postpartum ibuprofen or acetaminophen for first-line pain control. Seven patients crossed over or did not receive their allocated study drug, and 93 completed the study protocol in their assigned groups. We found no differences in baseline characteristics between groups, including mode of delivery, body mass index, parity, race, chronic hypertension, and maximum blood pressure prior to delivery. We did not find a difference in the duration of severe-range hypertension in the ibuprofen vs acetaminophen groups (35.3 vs 38.0 hours, P = .30). There were no differences between groups in the secondary outcome measures of time from delivery to last blood pressure ≥150/100 mm Hg, postpartum mean arterial pressure, maximum postpartum systolic or diastolic blood pressures, any postpartum blood pressure ≥160/110 mm Hg, short-acting antihypertensive use for acute blood pressure control, length of postpartum stay, need to extend postpartum stay for blood pressure control, antihypertensive use at discharge, or opioid use for inadequate pain control. In a subgroup analysis of patients who experienced severe-range hypertension, the mean time to blood pressure control in the acetaminophen group was 68.4 hours and ibuprofen group was 56.7 hours (P = .26). At 6 weeks postpartum, there were no differences between groups in the rates of obstetric triage visits, hospital readmissions, continued opioid use, or continued antihypertensive use.
CONCLUSION


The first-line use of ibuprofen rather than acetaminophen for postpartum pain did not lengthen the duration of severe-range hypertension in women with preeclampsia with severe features.",2018,"At 6 weeks postpartum, there were no differences between groups in the rates of obstetric triage visits, hospital readmissions, continued opioid use, or continued antihypertensive use.
","['postpartum hypertension in preeclampsia with severe features', '154 women for eligibility, of whom 100 met entry criteria, agreed to participate', 'women with postpartum hypertension', 'women with preeclampsia with severe features', 'Seven patients crossed over or did not receive their allocated study drug, and 93 completed the study protocol in their assigned groups', 'nonpregnant adults']","['ibuprofen', 'acetaminophen', 'ibuprofen vs acetaminophen', 'postpartum ibuprofen or acetaminophen']","['duration of severe-range hypertension', 'duration of severe-range hypertension, defined as the time (in hours) from delivery to the last blood pressure ≥160/110 mm Hg', 'blood pressure', 'time from delivery to last blood pressure ≥150/100 mm Hg, postpartum mean arterial pressure, maximum postpartum systolic or diastolic blood pressures, any postpartum blood pressure ≥160/110 mm Hg, short-acting antihypertensive use for acute blood pressure control, length of postpartum stay, need to extend postpartum stay for blood pressure control, antihypertensive use at discharge, or opioid use for inadequate pain control', 'rates of obstetric triage visits, hospital readmissions, continued opioid use, or continued antihypertensive use', 'mode of delivery, body mass index, parity, race, chronic hypertension, and maximum blood pressure prior to delivery', 'mean time to blood pressure control', 'time from delivery to last blood pressure ≥150/100 mm Hg, mean arterial pressure, need for antihypertensive medication at discharge, prolongation of hospital stay for blood pressure control, postpartum use of short-acting antihypertensives for acute blood pressure control, and opioid use for breakthrough pain', 'severe-range hypertension', 'serum aspartate aminotransferase or alanine aminotransferase']","[{'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C3650806', 'cui_str': 'Inadequate pain control (finding)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4301972', 'cui_str': 'Maximum blood pressure (observable entity)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough Pain'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}]",154.0,0.186846,"At 6 weeks postpartum, there were no differences between groups in the rates of obstetric triage visits, hospital readmissions, continued opioid use, or continued antihypertensive use.
","[{'ForeName': 'Nathan R', 'Initials': 'NR', 'LastName': 'Blue', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM. Electronic address: nblue1297@gmail.com.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Murray-Krezan', 'Affiliation': 'Division of Epidemiology, Biostatistics, and Preventive Medicine, Department of Internal Medicine, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Drake-Lavelle', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weinberg', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Holbrook', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Vivek R', 'Initials': 'VR', 'LastName': 'Katukuri', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Leeman', 'Affiliation': 'Departments of Family and Community Medicine and of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}, {'ForeName': 'Ellen L', 'Initials': 'EL', 'LastName': 'Mozurkewich', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2018.02.016']
847,31611155,"Effects of thoracic kinesio taping on pulmonary functions, respiratory muscle strength and functional capacity in patients with chronic obstructive pulmonary disease: A randomized controlled trial.","CONTEXT


Respiratory and peripheral muscle dysfunctions seen in Chronic Obstructive Pulmonary Disease (COPD) cause ventilatory limitation, dyspnea and inactivity, which then result in a reduction in functional capacity. Kinesio Taping (KT) is a rehabilitative technique performed by the cutaneous application of a special elastic tape, thus increasing muscle activation and blood circulation.
OBJECTIVES


To investigate the effects of KT application that was applied on respiratory muscles to improve pulmonary function, respiratory muscle strength and functional capacity in patients with COPD.
PATIENTS AND METHODS


In total, 27 COPD patients (16 in KT group, 11 in control group) were included. Thoracic KT was applied to facilitate the respiratory muscles along the subcostal area for KT group. Deep breathing exercises were applied to both groups. Interventions were done 2 days a week, through 6 weeks. Pulmonary function and maximal respiratory mouth pressures were measured with a spirometer. Severity of dyspnea and fatigue were assessed with Modified Medical Research Council dyspnea scale and Modified Borg Scale, respectively. Functional capacity was evaluated using six-minute walk test.
RESULTS


Percentage predicted of forced expiratory volume in one second (FEV 1 %), peak expiratory flow (PEF) value, percentage predicted of peak expiratory flow (PEF%) and walking distance were significantly increased in KT group (p = 0.038, p = 0.011, p = 0.013, p = 0.004, respectively). The severity of dyspnea and fatigue were reduced in KT group (p < 0.05). There was no significant change for other variables in-group and between-group analyses (p > 0.05).
CONCLUSIONS


Thoracic KT may be beneficial for improving pulmonary function and functional capacity in patients with COPD.",2020,"There was no significant change for other variables in-group and between-group analyses (p > 0.05).
","['patients with COPD', 'patients with chronic obstructive pulmonary disease', 'Chronic Obstructive Pulmonary Disease (COPD', '27 COPD patients (16 in KT group, 11 in control group) were included']","['Kinesio Taping (KT', 'KT', 'thoracic kinesio taping', 'Deep breathing exercises']","['Severity of dyspnea and fatigue', 'pulmonary function, respiratory muscle strength and functional capacity', 'forced expiratory volume', 'peak expiratory flow (PEF%) and walking distance', 'peak expiratory flow (PEF) value', 'pulmonary function and functional capacity', 'pulmonary functions, respiratory muscle strength and functional capacity', 'Pulmonary function and maximal respiratory mouth pressures', 'Functional capacity', 'severity of dyspnea and fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises (regime/therapy)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",27.0,0.0239342,"There was no significant change for other variables in-group and between-group analyses (p > 0.05).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Tomruk', 'Affiliation': 'Deaprtment of Pulmonary Rehabilitation, Dokuz Eylul University, Izmir, Turkey. Electronic address: murat.tomruk@deu.edu.tr.'}, {'ForeName': 'Elvan', 'Initials': 'E', 'LastName': 'Keleş', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Izmir Katip Çelebi University, Izmir, Turkey. Electronic address: elvan.felekoglu@ikc.edu.tr.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Özalevli', 'Affiliation': 'Deaprtment of Pulmonary Rehabilitation, Dokuz Eylul University, Izmir, Turkey. Electronic address: sevgi.sevgi.ozalevli@deu.edu.tr.'}, {'ForeName': 'Aylin Özgen', 'Initials': 'AÖ', 'LastName': 'Alpaydin', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Dokuz Eylul University, Izmir, Turkey. Electronic address: aylin.alpaydin@deu.edu.tr.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.08.018']
848,31541768,Efficacy and Safety of HDM SLIT Tablet in Japanese Adults with Allergic Asthma.,"BACKGROUND


The standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT) tablet has demonstrated efficacy and safety for allergic asthma (AA) in European trials.
OBJECTIVE


To evaluate the efficacy and safety of SQ HDM SLIT tablet treatment for up to 19 months in Japanese adults with AA.
METHODS


In this randomized, double-blind, placebo-controlled trial, patients aged 18 to 64 years with AA were randomly assigned (1:1:1) to SQ HDM SLIT doses of 10,000 or 20,000 Japanese Allergy Unit or placebo. Subjects had Asthma Control Questionnaire score of 1.0 to 1.5 and daily inhaled corticosteroid use of 200 to 400 μg of fluticasone propionate at randomization. The primary end point was the time from randomization to the first asthma exacerbation as the inhaled corticosteroid dose was being reduced.
RESULTS


Of the 826 randomized subjects, 693 (84%) completed the trial. No statistically significant differences between the active groups and the placebo group were observed for the primary or any other efficacy end points. However, post hoc analysis indicated a significant difference between the 20,000 Japanese Allergy Unit and placebo groups among subjects who used a short-acting β 2 -agonist during the baseline period (hazard ratio, 0.70; 95% CI, 0.48-1.00; P = .04997). No deaths or anaphylactic reactions were reported. Most adverse events were mild to moderate in severity.
CONCLUSIONS


The trial demonstrated a favorable safety profile of the SQ HDM SLIT tablet in Japanese adult patients with AA. The treatment appeared to be efficacious in patients requiring rescue medication (ie, short-acting β 2 -agonist) at baseline in the efficacy assessment using asthma exacerbation during inhaled corticosteroid reduction (JapicCTI number 121847).",2020,No deaths or anaphylactic reactions were reported.,"['Japanese adult patients with AA', 'patients aged 18-64 with AA', 'Subjects had Asthma Control Questionnaire score of 1.0-1.5 and daily inhaled corticosteroid (ICS) use of 200-400 μg of', 'Japanese adults with allergic asthma', 'Japanese adults with AA', 'Of the 826 randomized subjects, 693 (84%) completed the trial']","['SQ HDM SLIT-tablet', 'fluticasone propionate', 'HDM SLIT-tablet', 'placebo', 'SQ HDM SLIT doses of 10,000 or 20,000 Japanese Allergy Unit (JAU) or placebo']","['deaths or anaphylactic reactions', 'Efficacy and safety', 'time from randomization to the first asthma exacerbation']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4706265', 'cui_str': 'ACQ (Asthma Control Questionnaire) score'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0184904', 'cui_str': 'Slitting (procedure)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002792', 'cui_str': 'Anaphylactic Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",826.0,0.532977,No deaths or anaphylactic reactions were reported.,"[{'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Tanaka', 'Affiliation': 'Division of Respiratory Medicine and Allergology, Department of Medicine, School of Medicine, Showa University, Tokyo, Japan. Electronic address: tanakaa@med.showa-u.ac.jp.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tohda', 'Affiliation': 'Department of Respiratory Medicine and Allergology, Kindai University Faculty of Medicine, Osakasayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Okamiya', 'Affiliation': 'Torii Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Azuma', 'Affiliation': 'Torii Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Terada', 'Affiliation': 'Torii Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Adachi', 'Affiliation': 'International University of Health and Welfare/Sanno Hospital, Tokyo, Japan.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.09.002']
849,31561272,Subepithelial connective tissue graft with or without enamel matrix derivative for the treatment of multiple Class III-IV recessions in lower anterior teeth: A 3-year randomized clinical trial.,"BACKGROUND


This study compared clinical and patient-centered outcomes of subepithelial connective tissue graft (CTG) with and without enamel matrix derivative (EMD) in the treatment of multiple Class III-IV Miller periodontal recession (REC) defects on mandibular anterior teeth.
METHODS


This randomized clinical study evaluated 41 patients at 3 years follow-up. One hundred and fifty-six teeth were divided into two groups: test (CTG-EMD, 79 teeth) and control (CTG only, 77 teeth). Clinical REC, keratinized tissue (KT) width, percentage of root coverage, patient-centered outcomes were compared between the two groups.
RESULTS


At 36 months follow-up, patient level analysis showed that REC in the test group reduced significantly (5.71 ± 0.58 mm to 1.57 ± 0.85 mm) compared with the control group (5.94 ± 0.46 mm to 2.51 ± 0.62 mm) (P < 0.001), while KT width increased in the test group (1.51 ± 0.26 mm to 4.18 ± 0.34 mm) and was significantly greater than the control group (1.65 ± 0.21 mm to 2.90 ± 0.20 mm) (P < 0.001). At 36 months, tooth level analysis (Class III and Class IV groups) found less residual REC and increased KT in the test group compared with the control group (P < 0.01). Significantly less pain was reported at 2, 7, and 14 days follow-up post-surgery in the test group (P < 0.001).
CONCLUSIONS


The addition of EMD to CTG results in improved root coverage outcomes and higher amounts of KT width 36 months after treatment of Class III-IV REC on mandibular anterior teeth. The adjunctive use of EMD also resulted in significantly reduced pain 14 days post-surgery.",2020,"Significantly less pain was reported at 2 nd  , 7 th  and 14 days follow-up post-surgery in the test group (p<0.001).
","['41 patients over 3 years follow up', '156 teeth', 'multiple Class III-IV recessions in lower anterior teeth', 'Multiple Class III-IV Miller periodontal recession defects on lower anterior teeth']","['sub-epithelial connective tissue graft (CTG) with and without enamel matrix derivative (EMD', 'Sub-epithelial connective tissue graft with or without enamel matrix derivative', 'EMD']","['residual REC and increased KT', 'Clinical Recession (REC), Keratinized Tissue (KT) width, % root coverage, patient centered outcomes', 'pain', 'KT width increase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0442000', 'cui_str': 'Lower anterior (qualifier value)'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",156.0,0.0489282,"Significantly less pain was reported at 2 nd  , 7 th  and 14 days follow-up post-surgery in the test group (p<0.001).
","[{'ForeName': 'Faustino', 'Initials': 'F', 'LastName': 'Mercado', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hamlet', 'Affiliation': 'School of Dentistry and Oral Health, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Saso', 'Initials': 'S', 'LastName': 'Ivanovski', 'Affiliation': 'School of Dentistry, University of Queensland, Brisbane, Queensland, Australia.'}]",Journal of periodontology,['10.1002/JPER.19-0058']
850,29203509,Protocol for a feasibility study and randomised pilot trial of a low-intensity psychological intervention for depression in adults with autism: the Autism Depression Trial (ADEPT).,"INTRODUCTION


High rates of co-occurring depression are reported in autism spectrum disorder (ASD), a neurodevelopmental condition characterised by social communication impairments and repetitive behaviours. Cognitive-behavioural interventions adapted for ASD have been effective for anxiety problems. There have been evaluation studies of group cognitive-behavioural therapy for co-occurring depression, but no randomised trials investigating low-intensity psychological interventions as recommended in clinical guidelines for mild-moderate depression.
METHODS AND ANALYSIS


A feasibility study comprising a randomised controlled trial (RCT) and nested qualitative evaluation is under way as preparation for a definitive RCT. Participants (n=70) will be randomised to Guided Self-Help: a low-intensity psychological intervention based on behavioural activation adapted for ASD or treatment as usual. Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered. The analysis will aim to establish the rates of recruitment and retention for a larger-scale RCT as well as the most appropriate measure of depression to serve as primary outcome. The qualitative study will purposively sample up to 24 participants from each treatment group to consider the acceptability and feasibility of the intervention and the trial design.
ETHICS AND DISSEMINATION


Ethical approval has been received from WALES REC 3 (IRAS project ID: 191558) and the Health Research Authority with R&D approval from Avon and Wiltshire Mental Health Partnership and Northumberland, Tyne and Wear Foundation NHS Trusts. To our knowledge, this is the first study of a low-intensity intervention for depression in adults with autism. The results will inform the design of a definitive RCT. Dissemination will include peer-reviewed journal publications reporting the quantitative and qualitative research findings of the study and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN54650760; Pre-results.",2017,"Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered.",['adults with autism'],"['low-intensity psychological intervention', 'Guided Self-Help: a low-intensity psychological intervention based on behavioural activation adapted for ASD or treatment as usual', 'low-intensity intervention']","['depression symptoms, anxiety, social function and service use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",70.0,0.222004,"Outcomes including depression symptoms, anxiety, social function and service use will be measured at 10, 16 and 24 weeks postrandomisation and will be blind to group allocation for measures that are not self-administered.","[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology, University of Bath, Bath, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'Newcastle Cognitive and Behaviour Therapies (CBT) Centre, Northumberland Tyne & Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ensum', 'Affiliation': 'Bristol Adult Autism Services, Avon and Wiltshire Mental Health Partnership NHS Trust, Chippenham, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Population Health Sciences, Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Population Health Sciences, Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ingham', 'Affiliation': 'Northumberland, Tyne & Wear NHS Foundation Trust, Northumberland, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Population Health Sciences, School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Population Health Sciences, Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Parr', 'Affiliation': 'Institute of Neuroscience, University of Newcastle, Newcastle, UK.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'Population Health Sciences, School of Social and Community Medicine, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2017-019545']
851,27958774,Early-Stage Hyperoxia Is Associated with Favorable Neurological Outcomes and Survival after Severe Traumatic Brain Injury: A Post-Hoc Analysis of the Brain Hypothermia Study.,"The effects of hyperoxia on the neurological outcomes of patients with severe traumatic brain injury (TBI) are still controversial. We examined whether the partial pressure of arterial oxygen (PaO 2 ) and hyperoxia were associated with neurological outcomes and survival by conducting  post-hoc  analyses of the Brain Hypothermia (B-HYPO) study, a multi-center randomized controlled trial of mild therapeutic hypothermia for severe TBI. The differences in PaO 2  and PaO 2 /fraction of inspiratory oxygen (P/F) ratio on the 1st day of admission were compared between patients with favorable ( n  = 64) and unfavorable ( n  = 65) neurological outcomes and between survivors ( n  = 90) and deceased patients ( n  = 39). PaO 2  and the P/F ratio were significantly greater in patients with favorable outcomes than in patients with unfavorable neurological outcomes (PaO 2 : 252 ± 122 vs. 202 ± 87 mm Hg, respectively,  p  = 0.008; P/F ratio: 455 ± 171 vs. 389 ± 155, respectively,  p  = 0.022) and in survivors than in deceased patients (PaO 2 : 242 ± 117 vs. 193 ± 75 mm Hg, respectively,  p  = 0.005; P/F ratio: 445 ± 171 vs. 370 ± 141, respectively,  p  = 0.018). Similar tendencies were observed in subgroup analyses in patients with fever control and therapeutic hypothermia, and in patients with an evacuated mass or other lesions (unevacuated lesions). PaO 2  was independently associated with survival (odds ratio 1.008,  p  = 0.037). These results suggested that early-stage hyperoxia might be associated with favorable neurological outcomes and survival following severe TBI.",2017,"PaO 2  and the P/F ratio were significantly greater in patients with favorable outcomes than in patients with unfavorable neurological outcomes (PaO 2 : 252 ± 122 vs. 202 ± 87 mm Hg, respectively, p = 0.008; P/F ratio: 455 ± ","['Severe Traumatic Brain Injury', 'patients with severe traumatic brain injury (TBI', 'mild therapeutic hypothermia for severe TBI']","['partial pressure of arterial oxygen (PaO 2 ) and hyperoxia', 'hyperoxia']","['PaO 2  and the P/F ratio', 'survival']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}]","[{'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0242706', 'cui_str': 'Hyperoxia'}]","[{'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.100092,"PaO 2  and the P/F ratio were significantly greater in patients with favorable outcomes than in patients with unfavorable neurological outcomes (PaO 2 : 252 ± 122 vs. 202 ± 87 mm Hg, respectively, p = 0.008; P/F ratio: 455 ± ","[{'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Fujita', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Emergency Medicine, Tokuyama Central Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Kaneda', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Emergency and General Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Suehiro', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Dohi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kuroda', 'Affiliation': 'Department of Emergency, Disaster, and Critical Care Medicine, Faculty of Medicine, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Kobata', 'Affiliation': 'Osaka Mishima Emergency Critical Care Center, Osaka, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Tsuruta', 'Affiliation': 'Advanced Medical Emergency and Critical Care Center, Yamaguchi University Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Maekawa', 'Affiliation': 'Yamaguchi Prefectural Grand Medical Center, Yamaguchi, Japan.'}]",Journal of neurotrauma,['10.1089/neu.2016.4753']
852,31020797,Intra-aortic balloon pump counterpulsation in extensive myocardial infarction with persistent ischemia: The SEMPER FI pilot study.,"OBJECTIVES


This study aimed to prospectively investigate intra-aortic balloon pump counterpulsation (IABP) support in large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI).
BACKGROUND


Use of IABP is suggested to be effective by increasing diastolic aortic pressure, thereby improving coronary blood flow. This can only be expected with exhausted coronary autoregulation, typical in acute myocardial infarction complicated by persistent ischemia. In this situation, augmented diastolic pressure is expected to increase myocardial oxygenation.
METHODS


One hundred patients with large STEMI complicated by persistent ischemia after primary PCI were randomized to treatment with or without IABP therapy on top of standard care. IABP support was initiated following primary PCI, immediately after inclusion. Primary end point was all-cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months.
RESULTS


Mean age was 63 ± 10 years, 76% were male. Mean systolic and diastolic blood pressure were 120 ± 25 mmHg and 73 ± 17 mmHg. Mean heart rate was 75 ± 18 mmHg. Before PCI, mean summed ST-deviation was 21 ± 8 mm with only minimal ST-resolution after PCI. One patient in the IABP group reached the primary end point versus four patients in the control group (2% vs. 8%; p = 0.16). After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01).
CONCLUSIONS


In this pilot study, in patients with large STEMI and persistent ischemia after primary PCI, use of IABP showed a nonsignificant decrease in mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure at 6 months, and resulted in more rapid ST-resolution.",2020,"After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01).
","['extensive myocardial infarction with persistent ischemia', 'Mean age was 63\u2009±\u200910 years, 76% were male', 'One hundred patients with large STEMI complicated by persistent ischemia after primary PCI', 'large myocardial infarction complicated by persistent ischemia after primary percutaneous coronary intervention (PCI']","['IABP', 'Intra-aortic balloon pump counterpulsation', 'IABP therapy', 'aortic balloon pump counterpulsation (IABP']","['resolution of ST-deviation', 'diastolic aortic pressure', 'coronary blood flow', 'myocardial oxygenation', 'Mean systolic and diastolic blood pressure', 'cause mortality, need for (additional) mechanical hemodynamic support, or readmission for heart failure within 6 months', 'diastolic pressure', 'Mean heart rate', 'mortality, necessity for (additional) mechanical hemodynamic support or readmission for heart failure']","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0702122', 'cui_str': 'Intra-aortic balloon pump, device (physical object)'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump, device (physical object)'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",100.0,0.0286795,"After primary PCI, resolution of ST-deviation was significantly more pronounced in the IABP group (73 ± 17%) compared to the control group (56 ± 26%; p < 0.01).
","[{'ForeName': 'Lokien X', 'Initials': 'LX', 'LastName': 'van Nunen', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Wijnbergen', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Guus R G', 'Initials': 'GRG', 'LastName': 'Brueren', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Pim A L', 'Initials': 'PAL', 'LastName': 'Tonino', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Wilbert A', 'Initials': 'WA', 'LastName': 'Aarnoudse', 'Affiliation': 'Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Nico H J', 'Initials': 'NHJ', 'LastName': 'Pijls', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28289']
853,31581898,Effect of isometric handgrip exercise on the size of cephalic veins in patients with stage 3 and 4 chronic kidney disease: A randomized controlled trial.,"BACKGROUND


Proper vascular access is essential for the long-term survival of chronic haemodialysis patients. The preferred vascular access in terms of long-term function is the native arteriovenous fistula. The success of native arteriovenous fistula depends mainly on a sufficient vein diameter. Thus, any intervention that could increase vein diameter before arteriovenous fistula creation could improve its patency. We conduct a study to investigate the effect of local physical training, namely handgrip exercise, on the distal forearm cephalic vein diameter in patients with chronic renal disease.
MATERIAL AND METHODS


A total of 34 chronic renal disease patients (stage 3 and 4) were recruited in a randomized controlled trial. Handgrip exercise was performed for 8 weeks in the intervention group. Handgrip-strength measurement and distal forearm cephalic vein diameter of a non-dominant hand with and without tourniquet was recorded (measurement is taken 1 cm proximal to the radial styloid).
RESULTS


After 8 weeks, the mean cephalic vein diameter in the intervention group increased from 1.77 and 1.97 mm to 2.15 and 2.43 mm, without and with a tourniquet, respectively ( p  < 0.05). There is also a significant change in the mean diameter of distal forearm cephalic vein ( p  < 0.05) in the intervention group when measured in both the absence (mean change 0.39 ± 0.06 mm vs 0.01 ± 0.02 mm) and the presence of tourniquet (mean change 0.47 ± 0.07 mm vs 0.01 ± 0.01 mm).
CONCLUSION


These findings suggest that non-invasive handgrip exercise can increase in the diameter of the distal forearm cephalic vein, thereby increasing the rate of successful arteriovenous fistula creation.",2020,"There is also a significant change in the mean diameter of distal forearm cephalic vein ( p  < 0.05) in the intervention group when measured in both the absence (mean change 0.39 ± 0.06 mm vs 0.01 ± 0.02 mm) and the presence of tourniquet (mean change 0.47 ± 0.07 mm vs 0.01 ± 0.01 mm).
","['patients with stage 3 and 4 chronic kidney disease', 'chronic haemodialysis patients', 'patients with chronic renal disease', '34 chronic renal disease patients (stage 3 and 4']","['Handgrip exercise', 'local physical training, namely handgrip exercise', 'invasive handgrip exercise', 'isometric handgrip exercise']","['mean cephalic vein diameter', 'Handgrip-strength measurement and distal forearm cephalic vein diameter of a non-dominant hand with and without tourniquet', 'mean diameter of distal forearm cephalic vein', 'size of cephalic veins']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",34.0,0.0759296,"There is also a significant change in the mean diameter of distal forearm cephalic vein ( p  < 0.05) in the intervention group when measured in both the absence (mean change 0.39 ± 0.06 mm vs 0.01 ± 0.02 mm) and the presence of tourniquet (mean change 0.47 ± 0.07 mm vs 0.01 ± 0.01 mm).
","[{'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Kumar A/L S Katheraveloo', 'Affiliation': 'Vascular Surgery Unit, Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lenny', 'Initials': 'L', 'LastName': 'Suryani Safri', 'Affiliation': 'Vascular Surgery Unit, Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Loo', 'Initials': 'L', 'LastName': 'Guo Hou', 'Affiliation': 'Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aminnur', 'Initials': 'A', 'LastName': 'Hafiz Maliki', 'Affiliation': 'Department of General Surgery, Sarawak General Hospital, Kuching, Malaysia.'}, {'ForeName': 'Mohamad Azim', 'Initials': 'MA', 'LastName': 'Md Idris', 'Affiliation': 'Vascular Surgery Unit, Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hanafiah', 'Initials': 'H', 'LastName': 'Harunarashid', 'Affiliation': 'Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}]",The journal of vascular access,['10.1177/1129729819879314']
854,30976787,Uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation: the ELIMINATE-AF trial.,"AIMS


Edoxaban is a direct factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF). Uninterrupted edoxaban therapy in patients undergoing AF ablation has not been tested.
METHODS AND RESULTS


The ELIMINATE-AF trial, a multinational, multicentre, randomized, open-label, parallel-group study, was conducted to assess the safety and efficacy of once-daily edoxaban 60 mg (30 mg in patients indicated for dose reduction) vs. vitamin K antagonists (VKAs) in AF patients undergoing catheter ablation. Patients were randomized 2:1 to edoxaban vs. VKA. The primary endpoint (per-protocol population) was time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding during the period from the end of the ablation procedure to end of treatment (90 days). Overall, 632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent brain magnetic resonance imaging to assess silent cerebral infarcts. The primary endpoint (only major bleeds occurred) was observed in 0.3% (1 patient) on edoxaban and 2.0% (2 patients) on VKA [hazard ratio (95% confidence interval): 0.16 (0.02-1.73)]. In the ablation population (modified intent-to-treat population including patients with ablation), the primary endpoint was observed in 2.7% of edoxaban (N = 10) and 1.7% of VKA patients (N = 3) between start of ablation and end of treatment. There were one ischaemic and one haemorrhagic stroke, both in patients on edoxaban. Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62).
CONCLUSION


Uninterrupted edoxaban therapy represents an alternative to uninterrupted VKA treatment in patients undergoing AF ablation.",2019,"Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62).
","['patients undergoing AF ablation', '632 patients were enrolled, 614 randomized, and 553 received study drug and underwent ablation; 177 subjects underwent', 'AF patients undergoing catheter ablation', 'atrial fibrillation']","['Uninterrupted edoxaban therapy', 'Edoxaban', 'vitamin K antagonists (VKAs', 'edoxaban vs. VKA', 'edoxaban', 'Uninterrupted edoxaban vs. vitamin K antagonists', 'edoxaban therapy', 'brain magnetic resonance imaging']","['safety and efficacy', 'time to first occurrence of all-cause death, stroke, or International Society of Thrombosis and Haemostasis-defined major bleeding', 'Cerebral microemboli', 'major bleeds occurred', 'haemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0333227', 'cui_str': 'Microembolus (morphologic abnormality)'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}]",632.0,0.0578728,"Cerebral microemboli were detected in 13.8% (16) patients who received edoxaban and 9.6% (5) patients in the VKA group (nominal P = 0.62).
","[{'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division of Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Theodor-Stern-Kai 7, Frankfurt am Main, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Camm', 'Affiliation': ""Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, Blackshaw Road, London, UK.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cappato', 'Affiliation': 'Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Via A. Manzoni 56, Rozzano (MI), Italy.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Medical Faculty of the University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbüchel', 'Affiliation': 'Department of Cardiology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, Edegem, Belgium.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Department of Cardiology, Hospital Clinic, University of Barcelona, Carrer de Villarroel 170, Barcelona, Spain.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Division of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 1403 29th Street NW, Calgary, Alberta, Canada.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Abozguia', 'Affiliation': 'Blackpool Teaching Hospitals NHS Lancashire Cardiac Centre, Whinney Heys Road, Blackpool, UK.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Cardiology - Arrhythmias Unit, Ospedale ""F. Miulli"" Acquaviva delle Fonti, Strada Provinciale Acquaviva - Santeramo, Km4 Acquaviva delle Fonti, Bari, Italy.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Rauer', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Zielstattstr. 48, München, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Zielstattstr. 48, München, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Zielstattstr. 48, München, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Mönninghoff', 'Affiliation': 'Institute for Diagnostic and Interventional Radiology and Neuroradiology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, Essen, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, Prague, Czech Republic.'}]",European heart journal,['10.1093/eurheartj/ehz190']
855,31397255,Effects of High-Definition Transcranial Direct Current Stimulation and Theta Burst Stimulation for Modulating the Posterior Parietal Cortex.,"OBJECTIVES


Noninvasive brain stimulation methods, including high-definition transcranial direct current stimulation (HD-tDCS) and theta burst stimulation (TBS) have emerged as novel tools to modulate and explore brain function. However, the relative efficacy of these newer stimulation approaches for modulating cognitive functioning remains unclear. This study investigated the cognitive effects of HD-tDCS, intermittent TBS (iTBS) and prolonged continuous TBS (ProcTBS) and explored the potential of these approaches for modulating hypothesized functions of the left posterior parietal cortex (PPC).
METHODS


Twenty-two healthy volunteers attended four experimental sessions in a cross-over experimental design. In each session, participants either received HD-tDCS, iTBS, ProcTBS or sham, and completed cognitive tasks, including a divided attention task, a working memory maintenance task and an attention task (emotional Stroop test).
RESULTS


The results showed that compared to sham, HD-tDCS, iTBS and ProcTBS caused significantly faster response times on the emotional Stroop task. The effect size (Cohen's d) was d = .32 for iTBS (p < .001), .21 for ProcTBS (p = .01) and .15 for HD-tDCS (p = .044). However, for the performance on the divided attention and working memory maintenance tasks, no significant effect of stimulation was found.
CONCLUSIONS


The results suggest that repetitive transcranial magnetic stimulation techniques, including TBS, may have greater efficacy for modulating cognition compared with HD-tDCS, and extend existing knowledge about specific functions of the left PPC.",2019,"The effect size (Cohen's d) was d = .32 for iTBS (p < .001), .21 for ProcTBS",['Twenty-two healthy volunteers attended four experimental sessions in a cross-over experimental design'],"['HD-tDCS, iTBS, ProcTBS or sham, and completed cognitive tasks, including a divided attention task, a working memory maintenance task and an attention task (emotional Stroop test', 'HD-tDCS', 'HD-tDCS, intermittent TBS (iTBS) and prolonged continuous TBS (ProcTBS', 'high-definition transcranial direct current stimulation (HD-tDCS) and theta burst stimulation (TBS', 'High-Definition Transcranial Direct Current Stimulation and Theta Burst Stimulation']",['emotional Stroop task'],"[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}, {'cui': 'C0015320', 'cui_str': 'Experimental Design'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",22.0,0.0293111,"The effect size (Cohen's d) was d = .32 for iTBS (p < .001), .21 for ProcTBS","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Gan', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney 2031, NSW, Australia.'}, {'ForeName': 'Stevan', 'Initials': 'S', 'LastName': 'Nikolin', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney 2031, NSW, Australia.'}, {'ForeName': 'Colleen K', 'Initials': 'CK', 'LastName': 'Loo', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney 2031, NSW, Australia.'}, {'ForeName': 'Donel M', 'Initials': 'DM', 'LastName': 'Martin', 'Affiliation': 'School of Psychiatry, University of New South Wales, Sydney 2031, NSW, Australia.'}]",Journal of the International Neuropsychological Society : JINS,['10.1017/S1355617719000766']
856,28596861,"Systematic Medical Appraisal, Referral and Treatment (SMART) Mental Health Programme for providing innovative mental health care in rural communities in India.","BACKGROUND


India has few mental health professionals to treat the large number of people suffering from mental disorders. Rural areas are particularly disadvantaged due to lack of trained health workers. Ways to improve care could be by training village health workers in basic mental health care, and by using innovative methods of service delivery. The ongoing Systematic Medical Appraisal, Referral and Treatment Mental Health Programme will assess the acceptability, feasibility and preliminary effectiveness of a task-shifting mobile-based intervention using mixed methods, in rural Andhra Pradesh, India.
METHOD


The key components of the study are an anti-stigma campaign followed by a mobile-based mental health services intervention. The study will be done across two sites in rural areas, with intervention periods of 1 year and 3 months, respectively. The programme uses a mobile-based clinical decision support tool to be used by non-physician health workers and primary care physicians to screen, diagnose and manage individuals suffering from depression, suicidal risk and emotional stress. The key aim of the study will be to assess any changes in mental health services use among those screened positive following the intervention. A number of other outcomes will also be assessed using mixed methods, specifically focussed on reduction of stigma, increase in mental health awareness and other process indicators.
CONCLUSIONS


This project addresses a number of objectives as outlined in the Mental Health Action Plan of World Health Organization and India's National Mental Health Programme and Policy. If successful, the next phase will involve design and conduct of a cluster randomised controlled trial.",2015,"The programme uses a mobile-based clinical decision support tool to be used by non-physician health workers and primary care physicians to screen, diagnose and manage individuals suffering from depression, suicidal risk and emotional stress.","['rural Andhra Pradesh, India', 'rural communities in India']",['task-shifting mobile-based intervention'],['mental health awareness'],"[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}]","[{'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.142672,"The programme uses a mobile-based clinical decision support tool to be used by non-physician health workers and primary care physicians to screen, diagnose and manage individuals suffering from depression, suicidal risk and emotional stress.","[{'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'Research & Development, The George Institute for Global Health, 219-221 Splendor Forum, Jasola District Centre, New Delhi, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Devarapalli', 'Affiliation': 'Research & Development, The George Institute for Global Health, Hyderabad, Telengana, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kallakuri', 'Affiliation': 'Research & Development, The George Institute for Global Health, Hyderabad, Telengana, India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'Research & Development, The George Institute for Global Health, Hyderabad, Telengana, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, New Delhi, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}]","Global mental health (Cambridge, England)",['10.1017/gmh.2015.11']
857,28826281,Patients' Perceptions of an Exercise Program Delivered Following Discharge From Hospital After Critical Illness (the Revive Trial).,"BACKGROUND


The REVIVE randomized controlled trial (RCT) investigated the effectiveness of an individually tailored (personalized) exercise program for patients discharged from hospital after critical illness. By including qualitative methods, we aimed to explore patients' perceptions of engaging in the exercise program.
METHODS


Patients were recruited from general intensive care units in 6 hospitals in Northern Ireland. Patients allocated to the exercise intervention group were invited to participate in this qualitative study. Independent semistructured interviews were conducted at 6 months after randomization. Interviews were audio-recorded, transcribed, and content analysis used to explore themes arising from the data.
RESULTS


Of 30 patients allocated to the exercise group, 21 completed the interviews. Patients provided insight into the physical and mental sequelae they experienced following critical illness. There was a strong sense of patients' need for the exercise program and its importance for their recovery following discharge home. Key facilitators of the intervention included supervision, tailoring of the exercises to personal needs, and the exercise manual. Barriers included poor mental health, existing physical limitations, and lack of motivation. Patients' views of outcome measures in the REVIVE RCT varied. Many patients were unsure about what would be the best way of measuring how the program affected their health.
CONCLUSIONS


This qualitative study adds an important perspective on patients' attitude to an exercise intervention following recovery from critical illness, and provides insight into the potential facilitators and barriers to delivery of the program and how programs should be evolved for future trials.",2019,"RESULTS


Of 30 patients allocated to the exercise group","['30 patients allocated to the exercise group', 'patients discharged from hospital after critical illness', 'Patients were recruited from general intensive care units in 6 hospitals in Northern Ireland']","['Exercise Program Delivered Following Discharge From Hospital', 'exercise intervention', 'individually tailored (personalized) exercise program']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}]",[],,0.110915,"RESULTS


Of 30 patients allocated to the exercise group","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Ferguson', 'Affiliation': 'Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, Ulster University, Newtownabby, United Kingdom.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Bradley', 'Affiliation': ""Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Blackwood', 'Affiliation': ""Centre Experimental Medicine, School of Medicine, Dentistry & Biomedical Sciences, Queen's University Belfast, United Kingdom.""}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Health and Rehabilitation Technologies (CHaRT), Institute of Nursing and Health Research, Ulster University, Newtownabby, United Kingdom.'}]",Journal of intensive care medicine,['10.1177/0885066617724738']
858,27053273,NAP SACC UK: protocol for a feasibility cluster randomised controlled trial in nurseries and at home to increase physical activity and healthy eating in children aged 2-4 years.,"INTRODUCTION


Systematic reviews have identified the lack of intervention studies with young children to prevent obesity. This feasibility study examines the feasibility and acceptability of adapting the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) intervention in the UK to inform a full-scale trial.
METHODS AND ANALYSIS


A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes. Parents will be invited to participate in a digital media-based home component to set goals for making changes in the home. As this is a feasibility study, the sample size was not based on a power calculation but will indicate the likely response rates and intracluster correlations. Measures will be assessed at baseline and 8-10 months later. We will estimate the recruitment rate of nurseries and children and adherence to the intervention and data. Nursery measurements will include the Environmental Policy Assessment and Observation score and the nursery staff's review of the nursery environment. Child measurements will include height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time, and diet using the Child and Diet Evaluation Tool. Questionnaires with nursery staff and parents will measure mediators. A process evaluation will assess fidelity of intervention delivery and views of participants.
ETHICS AND DISSEMINATION


Ethical approval for this study was given by Wales 3 NHS Research Ethics Committee. Findings will be made available through publication in peer-reviewed journals, at conferences and to participants via the University of Bristol website. Data will be available from the University of Bristol Research Data Repository.
TRIAL REGISTRATION NUMBER


ISRCTN16287377.",2016,"A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes.","['12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive', 'Child Care', 'children aged 2-4 years']","['NAP SACC) intervention', 'training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes', 'Nutrition and Physical Activity Self-Assessment']","['physical activity and healthy eating', 'height and weight to calculate z-score body mass index (zBMI), accelerometer-determined minutes of moderate-to-vigorous physical activity per day and sedentary time']","[{'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0067518', 'cui_str': 'NAPS'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0029162'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",12.0,0.0593364,"A feasibility cluster randomised controlled trial in 12 nurseries in England, with 6 randomly assigned to the adapted NAP SACC UK intervention: nursery staff will receive training and support from an NAP SACC UK Partner to review the nursery environment (nutrition, physical activity, sedentary behaviours and oral health) and set goals for making changes.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kipping', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jago', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK Bristol Randomised Trials Collaboration, Bristol, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'South East Wales Trials Unit, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Papadaki', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Campbell', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brockman', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nicholson', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Moore', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}]",BMJ open,['10.1136/bmjopen-2015-010622']
859,31587569,Outcomes of Ultrasound-Guided Gastrocnemius Injection With Botulinum Toxin for Chronic Plantar Fasciitis.,"BACKGROUND


The objective of this study was to determine whether the injection of botulinum toxin A (BTA) in the medial head of the gastrocnemius muscle could yield improvements in function and disability in patients with chronic plantar fasciitis with follow-up 12 months after treatment.
METHODS


Thirty-two patients with chronic plantar fasciitis were included in the study and randomly allocated to the BTA and placebo groups. The visual analog scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) scores were used to evaluate pain levels pre- and postinjection as well as function of the foot, respectively. Patients were also asked to rate their treatment satisfaction 1 year after injection. The range of dorsiflexion was measured before and 12 months after the injection.
RESULTS


At the 12-month follow-up, the mean VAS decreased from 7.8 to 4 in the placebo group and from 8 to 0.33 in the BTA group. Furthermore, the mean AOFAS scores increased from 48.4 to 65.3 in the placebo group and from 45.5 to 90.6 in the BTA group. The postinjection scores in the BTA group were significantly higher than those in the placebo group ( P  < .001). Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up.
CONCLUSION


In patients with chronic plantar fasciitis, the use of BTA had a positive effect on improvement in pain and foot function 1 year after treatment.
LEVEL OF EVIDENCE


Level I, prospective randomized controlled trial.",2020,"Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up.
","['Chronic Plantar Fasciitis', 'patients with chronic plantar fasciitis', 'Thirty-two patients with chronic plantar fasciitis', 'patients with chronic plantar fasciitis with follow-up 12 months after treatment']","['placebo', 'BTA and placebo', 'botulinum toxin A (BTA', 'Ultrasound-Guided Gastrocnemius Injection With Botulinum Toxin']","['range of dorsiflexion', 'Patient satisfaction', 'mean AOFAS scores', 'pain and foot function', 'mean VAS', 'visual analog scale (VAS) and American Orthopaedic Foot & Ankle Society (AOFAS) scores', 'postinjection scores']","[{'cui': 'C1136148', 'cui_str': 'Heel Spur Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]",32.0,0.0972854,"Patient satisfaction in the BTA group was higher than that in the placebo group at the 12-month follow-up.
","[{'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Abbasian', 'Affiliation': 'Department of Orthopedics, Akhtar Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Baghbani', 'Affiliation': 'Department of Orthopedics, Akhtar Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Barangi', 'Affiliation': 'Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Paul Gilbert', 'Initials': 'PG', 'LastName': 'Fairhurst', 'Affiliation': 'Department of Orthopaedics, Inselspital, University Hospital of Berne, Berne, Switzerland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Ebrahimpour', 'Affiliation': 'Department of Orthopedics, Taleghani Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Krause', 'Affiliation': 'Department of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, Berne, Switzerland.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Hashemi', 'Affiliation': 'Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Foot & ankle international,['10.1177/1071100719875220']
860,28388850,Auditory and Visual Executive Functions in Children and Response to Methylphenidate: A Randomized Controlled Trial.,Objectives:  The aim of the study was to assess auditory and visually based executive functions (EFs) and the effect of methylphenidate (MPH) in children with ADHD.  Methods:  Thirty-six boys between the ages of 8.3 and 9.7 years with ADHD and 36 matched controls were included. The study group was randomized into MPH and placebo for 7 days each in a crossover design. A Cued Choice Reaction Time (CCRT) test that included incongruent cuing was administered at baseline and following 1 and 2 weeks.  Results:  The difference between the study and control groups was more evident with visual cues and incongruent cuing. Increased gains by children with predominantly hyperactive-impulsive\combined (HI\C) type of ADHD were observed under MPH.  Conclusions:  The differences between children with ADHD and typical children are more pronounce under incongruent auditory cuing . The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.,2020,The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.,"['Thirty-six boys between the ages of 8.3 and 9.7 years with ADHD and 36 matched controls were included', 'children with ADHD and typical children', 'children with ADHD']","['methylphenidate (MPH', 'Methylphenidate', 'MPH and placebo']","['visual cues and incongruent cuing', 'Auditory and Visual Executive Functions', 'pronounce under incongruent auditory cuing ']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",36.0,0.113036,The gains attributable to MPH are more specific to tasks involving auditory and visual EFs and in children with HI\C type ADHDs.,"[{'ForeName': 'Yaffa', 'Initials': 'Y', 'LastName': 'Hadar', 'Affiliation': 'Haifa University, Israel.'}, {'ForeName': 'Shraga', 'Initials': 'S', 'LastName': 'Hocherman', 'Affiliation': 'Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Lamm', 'Affiliation': 'Haifa University, Israel.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Tirosh', 'Affiliation': 'Technion-Israel Institute of Technology, Haifa, Israel.'}]",Journal of attention disorders,['10.1177/1087054717700978']
861,32119035,Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome: A Randomized Clinical Trial.,"Importance


Clinical evidence supports effectiveness of cannabidiol for treatment-resistant seizures in Dravet syndrome, but this trial is the first to evaluate the 10-mg/kg/d dose.
Objective


To evaluate the efficacy and safety of a pharmaceutical formulation of cannabidiol, 10 and 20 mg/kg/d, vs placebo for adjunctive treatment of convulsive seizures in patients with Dravet syndrome.
Design, Setting, and Participants


This double-blind, placebo-controlled, randomized clinical trial (GWPCARE2) recruited patients from April 13, 2015, to November 10, 2017, with follow-up completed on April 9, 2018. Of 285 patients screened from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel, 86 were excluded, and 199 were randomized. Patients were aged 2 to 18 years with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during the 4-week baseline period while receiving at least 1 antiepileptic drug. Data were analyzed from November 16 (date of unblinding) to December 13 (date of final outputs), 2018, based on intention to treat and per protocol.
Interventions


Patients received cannabidiol oral solution at a dose of 10 or 20 mg/kg per day (CBD10 and CBD20 groups, respectively) or matched placebo in 2 equally divided doses for 14 weeks. All patients, caregivers, investigators, and individuals assessing data were blinded to group assignment.
Main Outcomes and Measures


The primary outcome was change from baseline in convulsive seizure frequency during the treatment period. Secondary outcomes included change in all seizure frequency, proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score.
Results


Of 198 eligible patients (mean [SD] age, 9.3 [4.4] years; 104 female [52.5%]), 66 were randomized to the CBD10 group, 67 to the CBD20 group, and 65 to the placebo group, and 190 completed treatment. The percentage reduction from baseline in convulsive seizure frequency was 48.7% for CBD10 group and 45.7% for the CBD20 group vs 26.9% for the placebo group; the percentage reduction from placebo was 29.8% (95% CI, 8.4%-46.2%; P = .01) for CBD10 group and 25.7% (95% CI, 2.9%-43.2%; P = .03) for the CBD20 group. The most common adverse events were decreased appetite, diarrhea, somnolence, pyrexia, and fatigue. Five patients in the CBD20 group discontinued owing to adverse events. Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
Conclusions and Relevance


Adjunctive cannabidiol at doses of 10 and 20 mg/kg/d led to similar clinically relevant reductions in convulsive seizure frequency with a better safety and tolerability profile for the 10-mg/kg/d dose in children with treatment-resistant Dravet syndrome. Dose increases of cannabidiol to greater than 10 mg/kg/d should be tailored to individual efficacy and safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02224703.",2020,"Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
","['198 eligible patients (mean [SD] age, 9.3 [4.4] years; 104 female [52.5%]), 66 were randomized to the CBD10 group, 67 to the CBD20 group, and 65 to the placebo group, and 190 completed treatment', 'children with treatment-resistant Dravet syndrome', '285 patients screened from 38 centers in the United States, Spain, Poland, the Netherlands, Australia, and Israel, 86 were excluded, and 199 were randomized', 'Patients were aged 2 to 18 years with a confirmed diagnosis of Dravet syndrome and at least 4 convulsive seizures during the 4-week baseline period while receiving at least 1 antiepileptic drug', 'patients with Dravet syndrome', 'Dravet Syndrome', 'patients from April 13, 2015, to November 10, 2017, with follow-up completed on April 9, 2018']","['cannabidiol', 'Adjunctive Oral Cannabidiol vs Placebo', 'placebo', 'CBD20', 'cannabidiol oral solution', 'valproate sodium']","['Elevated liver transaminase levels', 'efficacy and safety', 'appetite, diarrhea, somnolence, pyrexia, and fatigue', 'convulsive seizure frequency', 'change in all seizure frequency, proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score', 'safety and tolerability profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0751122', 'cui_str': 'Myoclonic Epilepsy, Severe, Of Infancy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0037567', 'cui_str': 'Sodium Valproate'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0751494', 'cui_str': 'Convulsive Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",198.0,0.58063,"Elevated liver transaminase levels occurred more frequently in the CBD20 (n = 13) than the CBD10 (n = 3) group, with all affected patients given concomitant valproate sodium.
","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Miller', 'Affiliation': ""Department of Neurology, Nicklaus Children's Hospital, Miami, Florida.""}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Scheffer', 'Affiliation': ""Epilepsy Research Centre, The University of Melbourne at Austin Health and the Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'Gunning', 'Affiliation': 'Stichting Epilepsie Instellingen Nederland, Zwolle, the Netherlands.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Sanchez-Carpintero', 'Affiliation': 'Pediatric Neurology Unit, Clínica Universidad de Navarra, Navarra Institute for Health Research, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Nagel', 'Affiliation': 'Department of Neurology, Hospital Ruber Internacional, Madrid, Spain.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Perry', 'Affiliation': ""Jane and John Justin Neurosciences Center, Cook Children's Medical Center, Ft Worth, Texas.""}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Saneto', 'Affiliation': ""Neuroscience Institute, Division of Pediatric Neurology, Department of Neurology, Seattle Children's Hospital and University of Washington, Seattle.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research, Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, California.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Knappertz', 'Affiliation': 'Greenwich Biosciences, Inc, Carlsbad, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.0073']
862,31580931,Effects of stress-induced inflammation on reward processing in healthy young women.,"BACKGROUND


Anhedonia, or loss of interest or pleasure, is a feature of depression and transdiagnostic construct in psychopathology. Theory and compelling evidence from preclinical models implicates stress-induced inflammation as a psychobiological pathway to anhedonic behavior; however, this pathway has not been tested in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. Thus, the current experimental study used a standardized laboratory stressor task to elicit an inflammatory response and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.
METHODS


Healthy young women (age 18-25) completed behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control (n = 17). Tasks were re-administered 90-120 min post-stress to coincide with the peak of the stress-induced inflammatory response. Blood samples were collected for assessment of the pro-inflammatory cytokine interleukin-6 (IL-6) at baseline and 90 and 120 min post stressor.
RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low. Sensitivity to reward in the context of a motivation task was not altered in association with stress-induced IL-6.
CONCLUSIONS


Contrary to hypotheses, mild increases in IL-6 following acute stress were associated with increased reward responsiveness during reward learning and selective increases in motivation. Results contribute to an emerging and nuanced literature linking inflammation to reward processing, and demonstrate that behavioral effects of stress-induced inflammation may be detected in the laboratory setting.
CLINICAL TRIAL REGISTRATION


NCT03828604.",2020,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","['Healthy Young Women', 'Healthy young women (age 18-25) completed']","['Stress-Induced Inflammation', 'behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control']",['reward responsiveness during reward learning and selective increases in motivation'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0614676,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","[{'ForeName': 'Chloe C', 'Initials': 'CC', 'LastName': 'Boyle', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States. Electronic address: ccboyle@ucla.edu.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Stanton', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Julienne E', 'Initials': 'JE', 'LastName': 'Bower', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.09.023']
863,32412858,Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial.,"Background:  This analysis from the SMILE randomized study was performed to identify predictive factors associated with the greatest reductions in hypoglycemia with the Medtronic MiniMed™ 640G Suspend before low feature in adults with type 1 diabetes at high risk of severe hypoglycemia.  Methods:  Clinical and treatment-related factors associated with decreased sensor hypoglycemia (SH) were identified in participants from the intervention arm by univariate and multivariate analyses.  Results:  The reduction in SH events <54 mg/dL (<3.0 mmol/L) in the intervention group was significantly ( P  < 0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54 mg/dL. When excluding continuous glucose monitoring (CGM) factors not readily available (MNSHE, duration of SH events, area under the curve, mean amplitude of glycemic excursions), only the baseline mean time spent <54 mg/dL was found to be a significant independent predictor factor ( P  < 0.0001). Baseline HbA1 c , mean self-monitoring of blood glucose (SMBG), and coefficient of variation of SMBG were significant, although weak, predictors in the absence of any CGM data.  Conclusions:  The greatest reductions in SH events achieved with the MiniMed 640G system with the Suspend before low feature were seen in participants with higher baseline MNSHE. Measuring these (usually uncollected) events can be a useful tool to predict hypoglycemia reduction. ClinicalTrials.gov Registration Identifier NCT02733991.",2020,"The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001).","['adults with type 1 diabetes at high risk of severe hypoglycemia', 'patients at high risk of severe hypoglycemia']",['automated predictive insulin suspension'],"['CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE', 'sensor hypoglycemia (SH', 'sensor hypoglycemic events (MNSHE', 'reduction in SH events', 'Baseline HbA1c, mean self-monitoring of blood glucose (SMBG) and coefficient of variation (CV) of SMBG', 'SH events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.0353609,"The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001).","[{'ForeName': 'Aklilu', 'Initials': 'A', 'LastName': 'Habteab', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castañeda', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'de Valk', 'Affiliation': 'Department of Internal Medicine, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""Department of Internal Medicine King's College Hospital, Diabetes Research Group, London, United Kingdom.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milano, Italy.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': ""Department of Diabetology, Grenoble University Hospital, Service d'Endocrinologie, Grenoble, France.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'de Portu', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Da Silva', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vorrink-de Groot', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Medtronic, Northridge, California, USA.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0495']
864,31917050,Targeting malnutrition: Nutrition programs yield cost savings for hospitalized patients.,"BACKGROUND & AIMS


Between 30 and 50% of Colombian patients are malnourished or at-risk of malnutrition on hospital admission. Malnutrition is associated with poor outcomes and increased costs. We used cost modeling to estimate savings that could be derived from implementation of a nutrition therapy program for patients at malnutrition risk.
METHODS


The budget impact analysis was performed using previously-published outcomes data. Outcomes included length of stay, 30-day readmissions, and infectious/non-infectious complications. We developed a Markov model that compared patients who were assigned to receive early nutrition therapy (started within 24-48 h of hospital admission) with those assigned to receive standard nutrition therapy (not started early). Our model used a 60-day time-horizon and estimated event probabilities based on published data.
RESULTS


Average total costs over 60 days were $3770 US dollars for patients with delayed nutrition therapy vs $2419 for patients with early nutrition therapy-a savings of $1351 (35.8% decrease) per nutrition-treated patient. Cost differences between the groups were: $2703 vs $1600 for hospital-associated costs; $883 vs $665 for readmissions; and $176 vs $94 for complications. Taken broadly, the potential costs savings from a nutrition care program for an estimated 638,318 hospitalized Colombian patients at malnutrition risk is $862.6 million per year.
CONCLUSIONS


Our budget impact analysis demonstrated the potential for hospital-based nutrition care programs to improve health outcomes and reduce healthcare costs for hospitalized patients in Colombia. These findings provide a rationale for implementing comprehensive nutrition care in Colombian hospitals.",2020,"RESULTS


Average total costs over 60 days were $3770 US dollars for patients with delayed nutrition therapy vs $2419 for patients with early nutrition therapy-a savings of $1351 (35.8% decrease) per nutrition-treated patient.","['638,318 hospitalized Colombian patients at malnutrition risk is $862.6 million per year', 'patients at malnutrition risk', 'Colombian hospitals', '30 and 50% of Colombian patients are malnourished or at-risk of malnutrition on hospital admission', 'hospitalized patients', 'hospitalized patients in Colombia']","['standard nutrition therapy', 'early nutrition therapy']","['Cost differences', 'length of stay, 30-day readmissions, and infectious/non-infectious complications', 'healthcare costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2937349', 'cui_str': 'Nutrition Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.060816,"RESULTS


Average total costs over 60 days were $3770 US dollars for patients with delayed nutrition therapy vs $2419 for patients with early nutrition therapy-a savings of $1351 (35.8% decrease) per nutrition-treated patient.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Buitrago', 'Affiliation': 'Director Clinical Research Institute, Universidad Nacional de Colombia, Bogota, Colombia.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Vargas', 'Affiliation': 'Health Economics, EconoPharma Consulting, Mexico City, Mexico.'}, {'ForeName': 'Suela', 'Initials': 'S', 'LastName': 'Sulo', 'Affiliation': 'Health Economics and Outcomes Research, Abbott Nutrition, Columbus, OH, USA. Electronic address: suela.sulo@abbott.com.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Partridge', 'Affiliation': 'Health Economics and Outcomes Research, Abbott Nutrition, Columbus, OH, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Guevara-Nieto', 'Affiliation': 'Health Economics, EconoPharma Consulting, Mexico City, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gomez', 'Affiliation': 'Scientific and Medical Affairs and Market Access, Abbott Laboratories, Bogota, Colombia.'}, {'ForeName': 'Juan Diego', 'Initials': 'JD', 'LastName': 'Misas', 'Affiliation': 'Scientific and Medical Affairs and Market Access, Abbott Laboratories, Bogota, Colombia.'}, {'ForeName': 'M Isabel T D', 'Initials': 'MITD', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal de Minas Gerais, Medical School, Belo Horizonte, Brazil.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2019.12.025']
865,32412860,Effects of a Single Power Strength Training Session on Heart Rate Variability When Performed at Different Simulated Altitudes.,"Álvarez-Herms, Jesús, Sonia Julià-Sánchez, Hannes Gatterer, Francisco Corbi, Gines Viscor, and Martin Burtscher. Effects of a single power strength training session on heart rate variability when performed at different simulated altitudes.  High Alt Med Biol . 21:292-296, 2020.  Background:  This study assessed heart rate variability (HRV) after a single power strength training session performed at different hypoxic levels.  Materials and Methods:  Eight physically active subjects (31.1 ± 4.3 years; 177.6 ± 3.0 cm; 70.1 ± 5.2 kg) performed 6 bouts of 15-second continuous maximal jump exercises interspersed by 3 minutes of rest at different altitude levels (total volume of each session: 20 minutes). The normoxic hypoxia levels were FiO 2  low altitude: 20.9%; moderate altitude: 16.5%; and high altitude: 13.5%.  Results:  Average power output during the jumps was similar for all conditions (≅3150 W). Twenty-four hours before (PRE) and 24 hours after (POST) each training session, HRV parameters (R-R, square root of the mean of the sum of differences between intervals [RMSSD], pNN50, and very low frequency, low frequency, and high frequency) were determined without resulting in significant statistical differences, neither from PRE to POST nor between conditions ( p  > 0.05).  Conclusions:  This study showed a negligible perturbation of HRV parameters 24 hours after a single power strength session up to a hypoxic level equivalent to 4000 m. Further studies are needed to determine the hypoxia-dependent threshold and intensities of training loads affecting HRV.",2020,"Twenty-four hours before (PRE) and 24 hours after (POST) each training session, HRV parameters (R-R, square root of the mean of the sum of differences between intervals [RMSSD], pNN50, and very low frequency, low frequency, and high frequency) were determined without resulting in significant statistical differences, neither from PRE to POST nor between conditions ( p  > 0.05).  ",['Eight physically active subjects (31.1\u2009±\u20094.3 years; 177.6\u2009±\u20093.0\u2009cm; 70.1\u2009±\u20095.2\u2009kg) performed'],"['6 bouts of 15-second continuous maximal jump exercises', 'Single Power Strength Training Session']","['heart rate variability (HRV', 'normoxic hypoxia levels', 'Heart Rate Variability']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",8.0,0.014031,"Twenty-four hours before (PRE) and 24 hours after (POST) each training session, HRV parameters (R-R, square root of the mean of the sum of differences between intervals [RMSSD], pNN50, and very low frequency, low frequency, and high frequency) were determined without resulting in significant statistical differences, neither from PRE to POST nor between conditions ( p  > 0.05).  ","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-Herms', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Julià-Sánchez', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute for Mountain Emergency Medicine, Bolzano, Italy.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Corbi', 'Affiliation': 'National Institute of Physical Education of Catalonia, University of Lleida, Lleida, Spain.'}, {'ForeName': 'Gines', 'Initials': 'G', 'LastName': 'Viscor', 'Affiliation': 'Department of Cell Biology, Physiology and Immunology, Faculty of Biology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Burtscher', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Innsbruck, Austria.'}]",High altitude medicine & biology,['10.1089/ham.2020.0014']
866,28965097,Does laryngeal reinnervation or type I thyroplasty give better voice results for patients with unilateral vocal fold paralysis (VOCALIST): study protocol for a feasibility randomised controlled trial.,"INTRODUCTION


A functioning voice is essential for normal human communication. A good voice requires two moving vocal folds; if one fold is paralysed (unilateral vocal fold paralysis (UVFP)) people suffer from a breathy, weak voice that tires easily and is unable to function normally. UVFP can also result in choking and breathlessness. Current treatment for adults with UVFP is speech therapy to stimulate recovery of vocal fold (VF) motion or function and/or injection of the paralysed VF with a material to move it into a more favourable position for the functioning VF to close against. When these therapies are unsuccessful, or only provide temporary relief, surgery is offered. Two available surgical techniques are: (1) surgical medialisation; placing an implant near the paralysed VF to move it to the middle (thyroplasty) and/or repositioning the cartilage (arytenoid adduction) or (2) restoring the nerve supply to the VF (laryngeal reinnervation). Currently there is limited evidence to determine which surgery should be offered to adults with UVFP.
METHODS AND ANALYSIS


A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty. Participants will be followed up for 12 months. The primary outcome focuses on recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life.
ETHICS AND DISSEMINATION


Ethical approval was received from National Research Ethics Service-Committee Bromley (reference 11/LO/0583). In addition to dissemination of results through presentation and publication of peer-reviewed articles, results will be shared with key clinician and patient groups required to develop the future large-scale randomised controlled trial.
TRIAL REGISTRATION NUMBER


ISRCTN90201732; 16 December 2015.",2017,"METHODS AND ANALYSIS


A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty.","['30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty', 'patients with unilateral vocal fold paralysis (VOCALIST', 'adults with UVFP']",['UVFP'],"['choking and breathlessness', 'recruitment and retention, with secondary outcomes covering voice, swallowing and quality of life']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0396386', 'cui_str': 'Thyroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0034380'}]",30.0,0.153845,"METHODS AND ANALYSIS


A feasibility study to test the practicality of running a multicentre, randomised clinical trial of surgery for UVFP, including: (1) a qualitative study to understand the recruitment process and how it operates in clinical centres and (2) a small randomised trial of 30 participants recruited at 3 UK sites comparing non-selective laryngeal reinnervation to type I thyroplasty.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Blackshaw', 'Affiliation': 'Ear Institute, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Carding', 'Affiliation': 'School of Allied Health, Australian National Catholic University, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jepson', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mat Baki', 'Affiliation': 'Faculty of Medicine, National University of Malaysia, Malaysia.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Statistical Science, University College London, London, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schilder', 'Affiliation': 'Ear Institute, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Aneeka', 'Initials': 'A', 'LastName': 'Degun', 'Affiliation': 'Ear Institute, University College London, London, UK.'}, {'ForeName': 'Rosamund', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'UCL Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Husbands', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Knowles', 'Affiliation': 'Royal National Throat, Nose and Ear Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Walton', 'Affiliation': 'School of Allied Health, Australian National Catholic University, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Yakubu', 'Initials': 'Y', 'LastName': 'Karagama', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Heathcote', 'Affiliation': 'Department of Otolaryngology, Poole Hospital, Poole, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Birchall', 'Affiliation': 'Ear Institute, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2017-016871']
867,28527746,Sugar Restriction Leads to Increased Ad Libitum Sugar Intake by Overweight Adolescents in an Experimental Test Meal Setting.,"BACKGROUND


The impact of sugar restriction on subsequent sugar intake by overweight adolescents is unknown.
OBJECTIVE


Our aim was to examine the effect of sugar restriction on subsequent ad libitum sugar intake by overweight adolescents and whether habitual sugar intake and impulsivity influence the effect of sugar restriction on subsequent sugar intake.
DESIGN


This was an in-laboratory crossover feeding trial with sugar-exposure and sugar-restriction conditions.
PARTICIPANTS/SETTING


Eighty-seven overweight Latino and African-American adolescents underwent both meal conditions in two separate 8-hour in-laboratory visits.
INTERVENTION


Participants had access to ad libitum snack trays for 3 hours after the condition-specific meals.
MAIN OUTCOME MEASURES


Ad libitum sugar intake during the snack period was measured at each visit. Habitual sugar intake and impulsivity were assessed at baseline.
STATISTICAL ANALYSES PERFORMED


Repeated measures analysis of covariance was used to examine the within-person effect of meal condition on ad libitum sugar intake. Mixed models were used to examine the moderating effects of habitual sugar intake and impulsivity on the meal condition-ad libitum sugar intake relationship.
RESULTS


Participants consumed more ad libitum sugar during the snack period in the sugar-restriction condition than in the sugar-exposure condition (sugar restriction=78.63±38.84 g, sugar exposure=70.86±37.73 g; F=9.64, P=0.002). There was no relationship between habitual sugar intake and how much ad libitum sugar participants consumed during either condition. Higher impulsivity was associated with greater ad libitum sugar intake during both conditions (sugar restriction: b=.029, standard error=.01, P<0.05; sugar exposure: b=.034, standard error=.01, P<0.05).
CONCLUSIONS


Findings suggest that overweight adolescents restricted from sugar intake consume greater amounts of sugar when they are later given access to high-sugar foods. Overweight adolescents with higher impulsivity appear to consume greater amounts of sugar regardless of previous levels of sugar consumption. Compensatory sugar intake and trait impulsivity may have implications for dietary interventions in this population.",2017,"Higher impulsivity was associated with greater ad libitum sugar intake during both conditions (sugar restriction: b=.029, standard error=.01, P<0.05; sugar exposure: b=.034, standard error=.01, P<0.05).
","['Eighty-seven', 'overweight Latino and African-American adolescents', 'overweight adolescents', 'Overweight adolescents with higher impulsivity']","['Participants had access to ad libitum snack trays', 'sugar-exposure and sugar-restriction conditions', 'sugar restriction']","['Habitual sugar intake and impulsivity', 'Higher impulsivity', 'habitual sugar intake']","[{'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0184054', 'cui_str': 'Tray (attribute)'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake (observable entity)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",87.0,0.0644874,"Higher impulsivity was associated with greater ad libitum sugar intake during both conditions (sugar restriction: b=.029, standard error=.01, P<0.05; sugar exposure: b=.034, standard error=.01, P<0.05).
","[{'ForeName': 'Gillian A', 'Initials': 'GA', 'LastName': ""O'Reilly"", 'Affiliation': ''}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Black', 'Affiliation': ''}, {'ForeName': 'Jimi', 'Initials': 'J', 'LastName': 'Huh', 'Affiliation': ''}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Unger', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2017.03.025']
868,31603076,"Study protocol for a randomised double-blinded, sham-controlled, prospective, cross-over clinical trial of vagal neuromodulation for pain treatment in patients with chronic pancreatitis.","INTRODUCTION


The management of chronic pancreatitis (CP) is challenging and requires a personalised approach focused on the individual patient's main symptoms. Abdominal pain is the most prominent symptom in CP, where central pain mechanisms, including sensitisation and impaired pain modulation, often are involved. Recent clinical studies suggest that vagal nerve stimulation (VNS) induces analgesic effects through the modulation of central pain pathways. This study aims to investigate the effect of 2 weeks transcutaneous VNS (t-VNS) on clinical pain in patients with CP, in comparison to the effect of sham treatment.
METHODS AND ANALYSIS


Twenty-one patients with CP will be enrolled in this randomised, double-blinded, single-centre, sham-controlled, cross-over study. The study has two treatment periods: A 2-week active t-VNS using GammaCore device and a 2-week treatment with a sham device. During both treatment periods, the patients are instructed to self-administer VNS bilaterally to the cervical vagal area, three times per day. Treatment periods will be separated by 2 weeks. During the study period, patients will record their daily pain experience in a diary (primary clinical endpoint). In addition, all subjects will undergo testing which will include MRI, quantitative sensory testing, cardiac vagal tone assessment and collecting blood samples, before and after the two treatments to investigate mechanisms underlying VNS effects. The data will be analysed using the principle of intention to treat.
ETHICS AND DISSEMINATION


The regional ethics committee has approved the study: N-20170023. Results of the trial will be submitted for publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


The study is registered at www.clinicaltrials.gov: NCT03357029.",2019,"Abdominal pain is the most prominent symptom in CP, where central pain mechanisms, including sensitisation and impaired pain modulation, often are involved.","['patients with CP', 'patients with chronic pancreatitis', 'Twenty-one patients with CP']","['2\u2009weeks transcutaneous VNS (t-VNS', 'vagal nerve stimulation (VNS', 'vagal neuromodulation']",['clinical pain'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149521', 'cui_str': 'Pancreatitis, Chronic'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",21.0,0.540233,"Abdominal pain is the most prominent symptom in CP, where central pain mechanisms, including sensitisation and impaired pain modulation, often are involved.","[{'ForeName': 'Janusiya Anajan', 'Initials': 'JA', 'LastName': 'Muthulingam', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Søren Schou', 'Initials': 'SS', 'LastName': 'Olesen', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Tine Maria', 'Initials': 'TM', 'LastName': 'Hansen', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Asbjørn Mohr', 'Initials': 'AM', 'LastName': 'Drewes', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jens Brøndum', 'Initials': 'JB', 'LastName': 'Frøkjær', 'Affiliation': 'Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-029546']
869,31283355,The Effect of Group Counseling Based on Quality of Life Therapy on Stress and Life Satisfaction in Family Caregivers of Individuals with Substance Use Problem: A Randomized Controlled Trial.,"Family caregivers of people with substance abuse are exposed to psychological problems that diminish their life quality and satisfaction. The purpose of this study was to diagnose the efficacy of quality-of-life intervention on stress and life satisfaction of family caregivers of individuals with substance use problem. This is a randomized controlled trial conducted on 80 family caregivers of individuals with substance use problem in the process of withdrawal who were referred to a psychiatric center in southeastern Iran (2018). The intervention group received seven sessions of quality-of-life group counseling every other day based on predetermined content. Twelve weeks post-intervention, data were collected from the control and intervention groups using the Depression Anxiety and Stress Scales (DASS-21) and the Satisfaction with Life Scale (SWLS). The results were analyzed through statistical tests. After group counseling based on quality of life, the mean stress score in the family caregivers of the intervention group (11.50 ± 4.36) was significantly lower than in those of the control group (14.67 ± 4.93) ( p  = 0.003). Also, in the posttest, the mean score of life satisfaction in the intervention group (24.75 ± 4.28) was significantly higher than that of the control group (19.57 ± 7.33) ( p  = 0.001). Group counseling based on quality of life exerted a significantly positive impact on reducing the severity of stress and improving life satisfaction among family caregivers of individuals with substance use problem. Therefore, it is highly recommended that healthcare service providers incorporate this counseling approach in substance use withdrawal programs so as to increase the well-being and mental health of family caregivers.",2019,Group counseling based on quality of life exerted a significantly positive impact on reducing the severity of stress and improving life satisfaction among family caregivers of individuals with substance use problem.,"['80 family caregivers of individuals with substance use problem in the process of withdrawal who were referred to a psychiatric center in southeastern Iran (2018', 'family caregivers of individuals with substance use problem', 'Family Caregivers of Individuals with Substance Use Problem', 'Family caregivers of people with substance abuse']","['quality-of-life intervention', 'seven sessions of quality-of-life group counseling', 'Group Counseling Based on Quality of Life Therapy']","['Stress and Life Satisfaction', 'stress and life satisfaction', 'quality of life, the mean stress score', 'mean score of life satisfaction', 'severity of stress and improving life satisfaction', 'Depression Anxiety and Stress Scales (DASS-21) and the Satisfaction with Life Scale (SWLS']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}]","[{'cui': 'C0034380'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale (assessment scale)'}]",80.0,0.0428724,Group counseling based on quality of life exerted a significantly positive impact on reducing the severity of stress and improving life satisfaction among family caregivers of individuals with substance use problem.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Department of Psychiatric Nursing, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Rezaee', 'Affiliation': 'Department of Psychiatric Nursing, Nursing and Midwifery School, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Shakiba', 'Affiliation': 'Department of Psychiatry, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Navidian', 'Affiliation': 'Community Nursing Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.'}]",Issues in mental health nursing,['10.1080/01612840.2019.1609635']
870,28810425,Psychological and behavioral effects of obesity prevention campaigns.,"Public health campaigns are often used to prevent or reduce obesity. However, social psychological theory suggests these efforts might not be universally helpful and could potentially have detrimental consequences. This investigation explored the effects of obesity prevention campaigns. Participants were randomized to view either weight-focused or weight-neutral campaigns. Assessments at three time points (pre, post, and follow-up) examined the differences between groups in reactions to campaigns and changes in health behaviors and psychological outcomes. Compared with weight-neutral campaigns, weight-focused campaigns were associated with increases in negative perceptions of obesity and decreases in self-efficacy for health behavior change.",2019,"Compared with weight-neutral campaigns, weight-focused campaigns were associated with increases in negative perceptions of obesity and decreases in self-efficacy for health behavior change.",[],['weight-focused or weight-neutral campaigns'],"['health behaviors and psychological outcomes', 'negative perceptions of obesity']",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0018687'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0154223,"Compared with weight-neutral campaigns, weight-focused campaigns were associated with increases in negative perceptions of obesity and decreases in self-efficacy for health behavior change.","[{'ForeName': 'Courtney C', 'Initials': 'CC', 'LastName': 'Simpson', 'Affiliation': 'Virginia Commonwealth University, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Griffin', 'Affiliation': 'Virginia Commonwealth University, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, USA.'}]",Journal of health psychology,['10.1177/1359105317693913']
871,31183945,"Effect of the mineralocorticoid receptor antagonist eplerenone on liver fat and metabolism in patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial (MIRAD trial).","AIM


To investigate whether the mineralocorticoid receptor antagonist eplerenone has beneficial effects on liver fat and metabolism in patients with type 2 diabetes (T2D), the mineralocorticoid receptor antagonist in type 2 diabetes (MIRAD) trial.
MATERIAL AND METHODS


In this 26-week, double-blind, randomized, placebo-controlled trial, we enrolled 140 patients with T2D and high risk of cardiovascular disease. Patients were randomized 1:1 to either eplerenone with a target dose of 200 mg/day for patients with estimated glomerular filtration rate (eGFR) of 60 mL/min per 1.73 m 2  or more and 100 mg/day for patients with eGFR between 41 and 59 mL/min per 1.73 m 2  or placebo. The primary outcome measure was change in liver fat by proton magnetic resonance spectroscopy at week 26 from baseline; secondary outcomes were changes in metabolism, and safety by incident hyperkalaemia.
RESULTS


No changes in liver fat in the eplerenone group 0.91% (95% CI -0.57 to 2.39) or the placebo group -1.01% (-2.23 to 0.21) were found. The estimated absolute treatment difference was 1.92% (-3.81 to 0.01; P = 0.049). There was no beneficial impact on supporting secondary outcome variables of metabolism as fat mass distribution, lipid metabolism or insulin resistance. Despite a high dosage of eplerenone 164 versus 175 mg in patients treated with placebo (P = 0.228), the number of patients with incident hyperkalaemia (≥5.5 mmol/L) was low, with six in the eplerenone versus two in the placebo group (P = 0.276).
CONCLUSION


The addition of high doses of eplerenone to background antidiabetic and antihypertensive therapy does not show beneficial effects on liver fat and metabolism in patients with T2D.",2019,The estimated absolute treatment difference was 1.92% (-3.81 to 0.01; P = 0.049).,"['140 patients with T2D and high risk of cardiovascular disease', 'patients with T2D', 'patients with type 2 diabetes', 'patients with type 2 diabetes (T2D']","['mineralocorticoid receptor antagonist eplerenone', 'placebo', 'eplerenone']","['liver fat and metabolism', 'changes in metabolism, and safety by incident hyperkalaemia', 'metabolism as fat mass distribution, lipid metabolism or insulin resistance', 'liver fat', 'number of patients with incident hyperkalaemia', 'change in liver fat by proton magnetic resonance spectroscopy']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}]",140.0,0.717743,The estimated absolute treatment difference was 1.92% (-3.81 to 0.01; P = 0.049).,"[{'ForeName': 'Marie L', 'Initials': 'ML', 'LastName': 'Johansen', 'Affiliation': 'Department of Endocrinology-Internal Medicine, Copenhagen University Hospital, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, Inserm CIC Plurithémathique 1433, UMRS 1116 Inserm, CHRU Nancy, and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Holm', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Brandt', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Frandsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Chabanova', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Faculty of Health and Medical Sciences, Department of Biomedical Sciences, Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Endocrinology-Internal Medicine, Copenhagen University Hospital, Herlev-Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13809']
872,31575336,Different preprocessing strategies lead to different conclusions: A [ 11 C]DASB-PET reproducibility study.,"Positron emission tomography (PET) neuroimaging provides unique possibilities to study biological processes in vivo under basal and interventional conditions. For quantification of PET data, researchers commonly apply different arrays of sequential data analytic methods (""preprocessing pipeline""), but it is often unknown how the choice of preprocessing affects the final outcome. Here, we use an available data set from a double-blind, randomized, placebo-controlled [ 11 C]DASB-PET study as a case to evaluate how the choice of preprocessing affects the outcome of the study. We tested the impact of 384 commonly used preprocessing strategies on a previously reported positive association between the change from baseline in neocortical serotonin transporter binding determined with [ 11 C]DASB-PET, and change in depressive symptoms, following a pharmacological sex hormone manipulation intervention in 30 women. The two preprocessing steps that were most critical for the outcome were motion correction and kinetic modeling of the dynamic PET data. We found that 36% of the applied preprocessing strategies replicated the originally reported finding ( p  < 0.05). For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction. In conclusion, the choice of preprocessing strategy can have a major impact on a study outcome.",2020,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.",['30 women'],"['placebo', 'Positron emission tomography (PET', 'pharmacological sex hormone manipulation intervention']","['replication percentage', 'motion correction and kinetic modeling of the dynamic PET data']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0036884', 'cui_str': 'Gonadal Steroid Hormones'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]",384.0,0.255819,"For preprocessing strategies with motion correction, the replication percentage was 72%, whereas it was 0% for strategies without motion correction.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Ganz', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Svarer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Vibe G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Douglas N', 'Initials': 'DN', 'LastName': 'Greve', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Strother', 'Affiliation': 'Rotman Research Institute, Baycrest, Department of Medical Biophysics, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Gitte M', 'Initials': 'GM', 'LastName': 'Knudsen', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism,['10.1177/0271678X19880450']
873,27534622,Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development.,"BACKGROUND


Methods for developing a core outcome or information set require involvement of key stakeholders to prioritise many items and achieve agreement as to the core set. The Delphi technique requires participants to rate the importance of items in sequential questionnaires (or rounds) with feedback provided in each subsequent round such that participants are able to consider the views of others. This study examines the impact of receiving feedback from different stakeholder groups, on the subsequent rating of items and the level of agreement between stakeholders.
METHODS


Randomized controlled trials were nested within the development of three core sets each including a Delphi process with two rounds of questionnaires, completed by patients and health professionals. Participants rated items from 1 (not essential) to 9 (absolutely essential). For round 2, participants were randomized to receive feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple). Decisions as to which items to retain following each round were determined by pre-specified criteria.
RESULTS


Whilst type of feedback did not impact on the percentage of items for which a participant subsequently changed their rating, or the magnitude of change, it did impact on items retained at the end of round 2. Each core set contained discordant items retained by one feedback group but not the other (3-22 % discordant items). Consensus between patients and professionals in items to retain was greater amongst those receiving multiple group feedback in each core set (65-82 % agreement for peer-only feedback versus 74-94 % for multiple feedback). In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only. Variability in item scores across stakeholders was reduced following any feedback but this reduction was consistently greater amongst the multiple feedback group.
CONCLUSIONS


In the development of a core outcome or information set, providing feedback within Delphi questionnaires from all stakeholder groups separately may influence the final core set and improve consensus between the groups. Further work is needed to better understand how participants rate and re-rate items within a Delphi process.
TRIAL REGISTRATION


The three randomized controlled trials reported here were each nested within the development of a core information or outcome set to investigate processes in core outcome and information set development. Outcomes were not health-related and therefore trial registration was not applicable.",2016,"In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only.",[],"['peer-only or multiple stakeholder group feedback within Delphi surveys', 'feedback from their peer stakeholder group only (peer) or both stakeholder groups separately (multiple']",[],[],"[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1720467', 'cui_str': 'Only'}]",[],,0.0919007,"In addition, differences in round 2 scores were smaller between stakeholder groups receiving multiple feedback than between those receiving peer group feedback only.","[{'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Brookes', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Sara.T.Brookes@bristol.ac.uk.'}, {'ForeName': 'Rhiannon C', 'Initials': 'RC', 'LastName': 'Macefield', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, 1st floor Duncan Building, Daulby Street, Liverpool, L69 3GA, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'McNair', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Strong', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}]",Trials,['10.1186/s13063-016-1479-x']
874,27609783,An RCT of an Online Parenting Program for Parents of Preschool-Aged Children With ADHD Symptoms.,"Objective:  This randomized control trial evaluated the efficacy of an online self-help program in a sample of parents of preschoolers with ADHD symptoms.  Method:  Parents were randomly assigned to the intervention group ( n  = 27) or the delayed intervention group ( n  = 26). Child behavior measures were completed by mothers, fathers, and teachers, and parenting measures were completed by mothers.  Results:  Intent-to-treat analyses indicated significant post-intervention improvements in mother-rated child hyperactivity/inattention, restlessness/impulsivity, defiance/aggression, social functioning, and teacher-rated prosocial behavior, as well as significant improvements in maternal over-reactivity, verbosity, laxness, positive parenting, parenting satisfaction, self-efficacy, stress, and depression. At 6-month follow-up, effects were maintained for maternal over-reactivity and verbosity, parenting satisfaction and self-efficacy, and parental stress and depression.  Conclusion:  This study provides evidence for the effectiveness of an online self-help parenting program in reducing preschool inattentive behavior difficulties, and in increasing parenting competence, satisfaction in the parenting role, and maternal well-being.",2020,"This study provides evidence for the effectiveness of an online self-help parenting program in reducing preschool inattentive behavior difficulties, and in increasing parenting competence, satisfaction in the parenting role, and maternal well-being.","['parents of preschoolers with ADHD symptoms', 'Parents of Preschool-Aged Children With ADHD Symptoms', 'Parents']","['online self-help program', 'online self-help parenting program', 'delayed intervention group', 'Online Parenting Program']","['mother-rated child hyperactivity/inattention, restlessness/impulsivity, defiance/aggression, social functioning, and teacher-rated prosocial behavior', 'Child behavior measures', 'preschool inattentive behavior difficulties', 'maternal over-reactivity, verbosity, laxness, positive parenting, parenting satisfaction, self-efficacy, stress, and depression', 'maternal over-reactivity and verbosity, parenting satisfaction and self-efficacy, and parental stress and depression']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0424101', 'cui_str': 'Inattention (finding)'}, {'cui': 'C0542200', 'cui_str': 'Restlessness (phenothiazine)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0424348', 'cui_str': 'Defiant behavior (finding)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0542257', 'cui_str': 'Verbosity'}, {'cui': 'C0332536', 'cui_str': 'Laxness'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",,0.0544384,"This study provides evidence for the effectiveness of an online self-help parenting program in reducing preschool inattentive behavior difficulties, and in increasing parenting competence, satisfaction in the parenting role, and maternal well-being.","[{'ForeName': 'Nike', 'Initials': 'N', 'LastName': 'Franke', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Louise J', 'Initials': 'LJ', 'LastName': 'Keown', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sanders', 'Affiliation': 'The University of Auckland, New Zealand.'}]",Journal of attention disorders,['10.1177/1087054716667598']
875,31347742,Comparison of hypocalcemia rates between LigaSure and clamp-and-tie hemostatic technique in total thyroidectomies.,"BACKGROUND


Postoperative hypocalcemia (PH) is a serious complication after total thyroidectomy. This study aimed to compare PH rates between LigaSure Small Jaw (LSJ) and clamp-and-tie hemostatic technique in patients undergoing total thyroidectomy.
METHODS


Four hundred twenty patients were divided into two groups: group L (210 patients) performed with LSJ and group C (210 patients) with clamp-and-tie technique. Serum ionized calcium (iCa) was measured before and 12, 24, 48, 72 hours after surgery. PH was defined as iCa lower than 4.2 mg/dL in at least two measurements.
RESULTS


There was no significant difference between groups in sex, age, extent of surgery, pathology, and the strategy of intraoperative management of parathyroid glands (PG). The PH rate was significantly lower in group L compared to group C (22.9% vs 32.4%, P = .03).
CONCLUSIONS


Compared to clamp-and-tie technique, LigaSure is superior to decrease PH rate after total thyroidectomy.",2019,"The PH rate was significantly lower in group L compared to group C (22.9% vs 32.4%, P = .03).
","['Four hundred twenty patients', 'patients undergoing total thyroidectomy', 'total thyroidectomies']","['LigaSure and clamp-and-tie hemostatic technique', 'clamp-and-tie technique', 'LigaSure Small Jaw (LSJ) and clamp-and-tie hemostatic technique', 'LSJ']","['PH rate', 'PH', 'Serum ionized calcium (iCa', 'PH rates', 'hypocalcemia rates']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy (procedure)'}]","[{'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0019119', 'cui_str': 'Hemostatic Technics'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0025990', 'cui_str': 'Mandibular Micrognathia'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte (substance)'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",420.0,0.0329394,"The PH rate was significantly lower in group L compared to group C (22.9% vs 32.4%, P = .03).
","[{'ForeName': 'Feng-Yu', 'Initials': 'FY', 'LastName': 'Chiang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kang Dae', 'Initials': 'KD', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Kosin University, Busan, South Korea.'}, {'ForeName': 'Kyung', 'Initials': 'K', 'LastName': 'Tae', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, Seoul, South Korea.'}, {'ForeName': 'Ralph P', 'Initials': 'RP', 'LastName': 'Tufano', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Che-Wei', 'Initials': 'CW', 'LastName': 'Wu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'I-Cheng', 'Initials': 'IC', 'LastName': 'Lu', 'Affiliation': 'Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Pi-Ying', 'Initials': 'PY', 'LastName': 'Chang', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yi-Chu', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tzu-Yen', 'Initials': 'TY', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}]",Head & neck,['10.1002/hed.25884']
876,31568927,Personalized Biofeedback on Inhaler Adherence and Technique by Community Pharmacists: A Cluster Randomized Clinical Trial.,"BACKGROUND


Guidelines recommend that patients treated with inhalers receive adherence counseling and device training. Digital technologies that assess both inhaler adherence and technique have been developed. Using these technologies community pharmacists, who have regular contact with patients, are well placed to deliver personalized inhaler education.
OBJECTIVE


To determine the impact of a pharmacist intervention, informed by digital technology, on inhaler technique and adherence of patients with asthma in the community.
METHODS


A cluster randomized, parallel-group, multisite pharmacy study was conducted over 6 months. All study groups had an electronic device (inhaler compliance assessment device) attached to their maintenance inhaler. A biofeedback group received personalized inhaler training informed by data recorded by the device. The demonstration group received inhaler training, by physical demonstration with a placebo inhaler. The control group received usual care. The primary outcome was inhaler adherence, which was classified as ""actual adherence"" and expressed as the proportion of expected drug accumulation if adherence and technique had been perfect. Secondary outcomes were quality-of-life scores as measured by the St George's Respiratory Questionnaire, symptoms, and exacerbations.
RESULTS


A total of 152 participants (n = 74 biofeedback, n = 56 demonstration, and n = 22 control) were recruited. Asthma was the predominant condition among participants (n = 83), with chronic obstructive pulmonary disease (n = 55) and asthma/chronic obstructive pulmonary disease overlap also reported (n = 8). In intention-to-treat analysis, adherence in the biofeedback group during month 2 was 62%, 18% higher (95% CI, 6 to 30) than that in the demonstration group (P = .004) and 24% higher (95% CI, 9 to 40) than that in the control group (P = .003). During month 6, adherence was 14% higher (95% CI, -1 to 30; P = .07) in the biofeedback group than in the demonstration group and 31% higher (95% CI, 13 to 48; P = .001) than in the control group. At the end of the study, the biofeedback group had a sustained fall in St George's Respiratory Questionnaire from baseline, -6.1 (95% CI, -9 to -0.4; P = .04) and had significantly improved daily respiratory symptoms.
CONCLUSIONS


Community pharmacist-delivered inhaler training informed by a digital technology improved adherence and health status.",2020,"During month 6, adherence was 14% higher (95% CI: -1, 30, p=0.07) in the biofeedback group than the demonstration group, and 31% higher (95% CI: 13, 48, p=0.001) than the control group.","['participants (n=83), with Chronic Obstructive Pulmonary Disease (COPD) (n=55) and Asthma/COPD Overlap (ACO) also reported (n=8', 'patients with asthma in the community', '152 participants (n=74 biofeedback, n=56 demonstration and n=22 control) were recruited']","['Personalised biofeedback', 'pharmacist intervention', 'electronic device (INCA', 'inhaler training, by physical demonstration with a placebo inhaler', 'personalised inhaler training', 'adherence counselling and device training', 'usual care']","['adherence and health status', 'inhaler adherence which was classified as ""actual adherence"" and expressed as the proportion of expected drug accumulation if adherence and technique', ""quality-of-life scores as measured by the St George's Respiratory Questionnaire (SGRQ), symptoms and exacerbations"", 'daily respiratory symptoms', 'SGRQ']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0337871', 'cui_str': 'Inca (ethnic group)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}]",152.0,0.154409,"During month 6, adherence was 14% higher (95% CI: -1, 30, p=0.07) in the biofeedback group than the demonstration group, and 31% higher (95% CI: 13, 48, p=0.001) than the control group.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Dwyer"", 'Affiliation': 'Boots Retail (Ireland) Limited, Dublin, Ireland; School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Greene', 'Affiliation': 'Department of Population Health Science, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'MacHale', 'Affiliation': 'Clinical Research Centre, Beaumont Hospital, RCSI, Dublin, Ireland.'}, {'ForeName': 'Breda', 'Initials': 'B', 'LastName': 'Cushen', 'Affiliation': 'Clinical Research Centre, Beaumont Hospital, RCSI, Dublin, Ireland.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Sulaiman', 'Affiliation': 'Clinical Research Centre, Beaumont Hospital, RCSI, Dublin, Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Boland', 'Affiliation': 'Data Science Centre, RCSI, Dublin, Ireland.'}, {'ForeName': 'Sinthia', 'Initials': 'S', 'LastName': 'Bosnic-Anticevich', 'Affiliation': 'School of Medical Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Matshediso C', 'Initials': 'MC', 'LastName': 'Mokoka', 'Affiliation': 'Clinical Research Centre, Beaumont Hospital, RCSI, Dublin, Ireland.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Reilly', 'Affiliation': 'Trinity Centre for Bioengineering, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Trinity Centre for Bioengineering, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Ryder', 'Affiliation': 'School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Costello', 'Affiliation': 'Clinical Research Centre, Beaumont Hospital, RCSI, Dublin, Ireland; Department of Respiratory Medicine, RCSI, Dublin, Ireland. Electronic address: rcostello@rcsi.ie.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.09.008']
877,32413933,Adalimumab for maintenance of remission in Crohn's disease.,"BACKGROUND


Conventional medications for Crohn's disease (CD) include anti-inflammatory drugs, immunosuppressants and corticosteroids. If an individual does not respond, or loses response to first-line treatments, then biologic therapies such as tumour necrosis factor-alpha (TNF-α) antagonists such as adalimumab are considered for treating CD. Maintenance of remission of CD is a clinically important goal, as disease relapse can negatively affect quality of life.
OBJECTIVES


To assess the efficacy and safety of adalimumab for maintenance of remission in people with quiescent CD.
SEARCH METHODS


We searched the Cochrane IBD Group Specialized Register, CENTRAL, MEDLINE, Embase, and clinicaltrials.gov from inception to April 2019.
SELECTION CRITERIA


We considered for inclusion randomized controlled trials (RCTs) comparing adalimumab to placebo or to an active comparator.
DATA COLLECTION AND ANALYSIS


We analyzed data on an intention-to-treat basis. We calculated risk ratios (RRs) and corresponding 95% confidence intervals (95% CI) for dichotomous outcomes. The primary outcome was failure to maintain clinical remission. We define clinical remission as a Crohn's Disease Activity Index (CDAI) score of < 150. Secondary outcomes were failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs). We assessed biases using the Cochrane 'Risk of bias' tool. We used GRADE to assess the overall certainty of evidence supporting the primary outcome.
MAIN RESULTS


We included six RCTs (1158 participants). We rated four trials at low risk of bias and two trials at unclear risk of bias. All participants had moderate-to-severe CD that was in clinical remission. Four studies were placebo-controlled (1012 participants). Two studies (70 participants) compared adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine) in participants who had an ileocolic resection prior to study enrolment. Adalimumab versus placebo Fifty-nine per cent (252/430) of participants treated with adalimumab failed to maintain clinical remission at 52 to 56 weeks, compared with 86% (217/253) of participants receiving placebo (RR 0.70, 95% CI 0.64 to 0.77; 3 studies, 683 participants; high-certainty evidence). Among those who received prior TNF-α antagonist therapy, 69% (129/186) of adalimumab participants failed to maintain clinical or endoscopic response at 52 to 56 weeks, compared with 93% (108/116) of participants who received placebo (RR 0.76, 95% CI 0.68 to 0.85; 2 studies, 302 participants; moderate-certainty evidence). Fifty-one per cent (192/374) of participants who received adalimumab failed to maintain clinical remission at 24 to 26 weeks, compared with 79% (149/188) of those who received placebo (RR 0.66, 95% CI 0.52 to 0.83; 2 studies, 554 participants; moderate-certainty evidence). Eighty-seven per cent (561/643) of participants who received adalimumab reported an AE compared with 85% (315/369) of participants who received placebo (RR 1.01, 95% CI 0.94 to 1.09; 4 studies, 1012 participants; high-certainty evidence). Serious adverse events were seen in 8% (52/643) of participants who received adalimumab and 14% (53/369) of participants who received placebo (RR 0.56, 95% CI 0.39 to 0.80; 4 studies, 1012 participants; moderate-certainty evidence) and withdrawal due to AEs was reported in 7% (45/643) of adalimumab participants compared to 13% (48/369) of placebo participants (RR 0.59, 95% CI 0.38 to 0.91; 4 studies, 1012 participants; moderate-certainty evidence). Commonly-reported AEs included CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain. Adalimumab versus active comparators No studies reported failure to maintain clinical remission. One study reported on failure to maintain clinical response and endoscopic remission at 104 weeks in ileocolic resection participants who received either adalimumab, azathioprine or mesalamine as post-surgical maintenance therapy. Thirteen per cent (2/16) of adalimumab participants failed to maintain clinical response compared with 54% (19/35) of azathioprine or mesalamine participants (RR 0.23, 95% CI 0.06 to 0.87; 51 participants). Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence). One study reported on failure to maintain endoscopic response at 24 weeks in ileocolic resection participants who received either adalimumab or 6-mercaptopurine (6-MP) as post-surgical maintenance therapy. Nine per cent (1/11) of adalimumab participants failed to maintain endoscopic remission compared with 50% (4/8) of 6-MP participants (RR 0.18, 95% CI 0.02 to 1.33; 19 participants).
AUTHORS' CONCLUSIONS


Adalimumab is an effective therapy for maintenance of clinical remission in people with quiescent CD. Adalimumab is also effective in those who have previously been treated with TNF-α antagonists. The effect of adalimumab in the post-surgical setting is uncertain. More research is needed in people with recent bowel surgery for CD to better determine treatment plans following surgery. Future research should continue to explore factors that influence initial and subsequent biologic selection for people with moderate-to-severe CD. Studies comparing adalimumab to other active medications are needed, to help determine the optimal maintenance therapy for CD.",2020,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","['people with moderate-to-severe CD', ""Crohn's disease"", 'people with quiescent CD', 'participants who had an ileocolic resection prior to study enrolment']","['adalimumab to placebo', 'azathioprine', 'adalimumab', '6-MP', 'adalimumab or 6-mercaptopurine (6-MP', 'TNF-α antagonist therapy', 'adalimumab, azathioprine or mesalamine', 'azathioprine or mesalamine', 'mesalamine', 'Adalimumab', 'Adalimumab versus active comparators', 'adalimumab to active medication (azathioprine, mesalamine or 6-mercaptopurine', 'placebo']","['maintain clinical response', 'maintain clinical or endoscopic response', 'maintain endoscopic remission', ""Crohn's Disease Activity Index (CDAI) score"", 'efficacy and safety', 'maintain clinical remission', 'moderate-certainty evidence) and withdrawal due to AEs', 'failure to maintain clinical response, endoscopic remission, endoscopic response, histological remission and adverse events (AEs', 'CD aggravation, arthralgia, nasopharyngitis, urinary tract infections, headache, nausea, fatigue and abdominal pain', 'failure to maintain clinical remission', 'calculated risk ratios (RRs', 'Serious adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1280902', 'cui_str': 'Ileocolic resection'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",,0.562927,"Six per cent (1/16) of participants who received adalimumab failed to maintain endoscopic remission, compared with 57% (20/35) of participants who received azathioprine or mesalamine (RR 0.11, 95% CI 0.02 to 0.75; 51 participants; very low-certainty evidence).","[{'ForeName': 'Cassandra M', 'Initials': 'CM', 'LastName': 'Townsend', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Tran M', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cepek', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Abbass', 'Affiliation': 'Schulich School of Medicine & Dentistry, University of Western Ontario, London, Canada.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Parker', 'Affiliation': 'Robarts Clinical Trials, London, Canada.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'MacDonald', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Reena', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jairath', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Canada.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012877.pub2']
878,32415664,Neuronal Biomarkers in Predicting Neurodevelopmental Outcome in Term Babies with Perinatal Asphyxia.,"OBJECTIVE


To assess whether serum levels of neuronal biomarkers (S100 calcium-binding protein B and Neuron specific enolase) correlate with the neurodevelopmental outcome of term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia.
METHODS


This randomized controlled trial was conducted in a tertiary care teaching hospital, south India. There were 162 term infants with moderate to severe hypoxic ischemic encephalopathy who were randomized into 2 groups (Group A and B). Neonates in Group A and B received normothermia and therapeutic hypothermia respectively. Serum levels of neuronal biomarkers were estimated at 0, 24 (±1) and 72 (±1) h after birth using sandwich ELISA in both groups. All neonates were carefully monitored till discharge. Infants who survived the neonatal period were followed up in the high risk clinic for 18 mo and neurodevelopmental assessment was done using Developmental Assessment Scale for Indian Infants (DASII). Neurodevelopmental outcomes between the two groups were compared using Chi square test and neuronal biomarker levels between the groups were compared using Mann Whitney test.
RESULTS


The baseline maternal and neonatal characteristics in both groups were comparable. There was statistically insignificant lesser mortality in therapeutic hypothermia group compared to normothermia group with Risk Ratio (RR): 0.82 (28.2% vs. 34.5%, 95% CI: 0.52-1.29, p = 0.38). Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo. There was no significant correlation between S100B and Neuron specific enolase levels and neurodevelopmental outcome.
CONCLUSIONS


Serum levels of neuronal biomarkers (S100B and Neuron specific enolase) do not correlate with the long term neurodevelopmental outcome among these infants.",2020,"Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo.","['162 term infants with moderate to severe hypoxic ischemic encephalopathy', 'Term Babies with Perinatal Asphyxia', 'term neonates at 18 mo who had hypoxic ischemic encephalopathy and underwent therapeutic hypothermia', 'tertiary care teaching hospital, south India']",[],"['Chi square test and neuronal biomarker levels', 'baseline maternal and neonatal characteristics', 'S100B and Neuron specific enolase levels and neurodevelopmental outcome', 'Neurodevelopmental outcomes', 'motor and mental scores', 'mortality', 'Serum levels of neuronal biomarkers']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],"[{'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",162.0,0.0912209,"Among the survivors, children in therapeutic hypothermia group had better motor and mental scores compared to those in normothermia group at 18 mo.","[{'ForeName': 'R Christina', 'Initials': 'RC', 'LastName': 'Catherine', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'B Vishnu', 'Initials': 'BV', 'LastName': 'Bhat', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. drvishnubhat@yahoo.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Adhisivam', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Shruthi K', 'Initials': 'SK', 'LastName': 'Bharadwaj', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.'}, {'ForeName': 'Vickneshwaran', 'Initials': 'V', 'LastName': 'Vinayagam', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Palanivel', 'Initials': 'P', 'LastName': 'Chinnakali', 'Affiliation': 'Department of Preventive & Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03283-2']
879,28134056,Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.,"Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.",2017,"In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries.",[],['stroke rehabilitation compared to usual care'],[],[],"[{'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}]",[],,0.21566,"In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': '1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': '1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': '2 Sydney Medical School, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': '3 Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': '1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gudlavalleti Vs', 'Initials': 'GV', 'LastName': 'Murthy', 'Affiliation': '6 Indian Institute of Public Health, Hyderabad, India.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': '1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Bindiganavale R', 'Initials': 'BR', 'LastName': 'Shamanna', 'Affiliation': '8 School of Medical Sciences, University of Hyderabad, Hyderabad, Telangana, India.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': '1 The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': '9 School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': '10 Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': '11 Academic Section of Geriatric Medicine, Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Shweta J', 'Initials': 'SJ', 'LastName': 'Verma', 'Affiliation': '12 Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Felix', 'Affiliation': '3 Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alim', 'Affiliation': '3 Research and Development, George Institute for Global Health India, Hyderabad, Telangana, India.'}, {'ForeName': 'Dorcas Bc', 'Initials': 'DB', 'LastName': 'Gandhi', 'Affiliation': '12 Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Jeyaraj Durai', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': '12 Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493016674956']
880,32414563,Impact of an educational intervention in primary care on fasting blood glucose levels and diabetes knowledge among patients with type 2 diabetes mellitus in rural China.,"OBJECTIVE


To assess the impact of an educational intervention for type 2 diabetes mellitus (T2DM) in primary care in rural China, on fasting blood glucose (FBG) level and diabetes knowledge.
METHODS


Patients with T2DM (n = 1,589) in 18 township health centres in three counties in Jiangsu Province were randomly divided into an intervention group receiving educational intervention and follow-up visits, and a control group with standard care. Questionnaires and medical records, including FBG level and diabetes knowledge score, were compared, at baseline and follow-up. Propensity score matching and Difference-in-Difference analysis were used.
RESULTS


The FBG level decreased significantly in the intervention group compared to the control group, DID=-0.53 mmol/l, (CI95 % -0.90 to -0.16). The diabetes knowledge score increased significantly in the intervention group compared to the control group, DID = 0.91, (CI95 % 0.64-1.18). The FBG level and diabetes knowledge score improved significantly in the intervention group in all counties.
CONCLUSIONS


The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
PRACTICE IMPLICATIONS


Educational intervention and increased collaboration between hospitals and primary care may improve diabetes care in rural China.",2020,"The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
","['Patients with T2DM (n = 1,589) in 18 township health centres in three counties in Jiangsu Province', 'patients with type 2 diabetes mellitus in rural China', 'rural China', 'type 2 diabetes mellitus (T2DM) in primary care in rural China, on fasting blood glucose (FBG) level and diabetes knowledge']","['educational intervention', 'intervention group receiving educational intervention and follow-up visits, and a control group with standard care']","['diabetes knowledge score', 'FBG level and diabetes knowledge score', 'FBG level', 'fasting blood glucose levels and diabetes knowledge', 'Questionnaires and medical records, including FBG level and diabetes knowledge score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",1589.0,0.023265,"The educational intervention and increased collaboration between hospitals and primary care improved the FBG level and diabetes knowledge score in the intervention group compared to the control group after one year.
","[{'ForeName': 'Shaofan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Stockholm Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden; Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China. Electronic address: shaofan.chen@ki.se.'}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Qian', 'Affiliation': 'School of Health Policy and Management, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China. Electronic address: dqian@njmu.edu.cn.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Burström', 'Affiliation': 'Health Outcomes and Economic Evaluation Research Group, Stockholm Centre for Healthcare Ethics, Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, SE-17177 Stockholm, Sweden; Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; Center for Health Policy Studies, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Burström', 'Affiliation': 'Equity and Health Policy Research Group, Department of Global Public Health, Karolinska Institutet, SE-17177 Stockholm, Sweden; Center for Health Policy Studies, Nanjing Medical University, No. 101 Longmian Avenue, Nanjing 211166, China.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.010']
881,31565758,Combining a UV photo intervention with self-affirmation or self-compassion exercises: implications for skin protection.,"The current study tested whether self-affirmation or self-compassion exercises, shown to increase message acceptance, could maximize the benefit of a UV photo intervention on skin protection cognitions. College women (N = 167) were randomly assigned to: (1) view a UV photo or Black and White (no-UV) photo of their face and (2) write a self-affirmation, self-compassion, or neutral essay. Participants who saw their UV photo reported healthier cognitions, including greater perceived vulnerability and intentions to protect skin. Within the self-compassion condition, participants who saw their UV photo were also more likely to take the sunscreen packets offered. However, neither self-affirmation nor self-compassion enhanced the effect of the UV photo. Within the UV condition, women who completed these exercises had similar (and occasionally less healthy) cognitions and behavior as those who wrote a neutral essay. The benefits of self-affirmation and self-compassion in conjunction with health messages may be limited to higher risk groups who experience more message defensiveness than the current sample.",2020,"The current study tested whether self-affirmation or self-compassion exercises, shown to increase message acceptance, could maximize the benefit of a UV photo intervention on skin protection cognitions.",['College women (N\u2009=\u2009167'],"['UV photo or Black and White (no-UV) photo of their face and (2) write a self-affirmation, self-compassion, or neutral essay', 'UV photo intervention with self-affirmation or self-compassion exercises', 'self-affirmation or self-compassion exercises']","['vulnerability and intentions to protect skin', 'skin protection cognitions', 'healthier cognitions']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0600647', 'cui_str': 'Essays'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0195548,"The current study tested whether self-affirmation or self-compassion exercises, shown to increase message acceptance, could maximize the benefit of a UV photo intervention on skin protection cognitions.","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Hagerman', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA. mstock@gwu.edu.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}, {'ForeName': 'Janine B', 'Initials': 'JB', 'LastName': 'Beekman', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'Behavioral Research Program, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Butler', 'Affiliation': 'George Washington University, 2125 G St. NW, Room 306, Washington, DC, 20052, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00104-6']
882,32091610,"Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial.","INTRODUCTION


The French army has implemented an algorithm based on the acronym ""MARCHE RYAN,"" each letter standing for a key action to complete in order to help first care providers during emergency casualty care. On the battlefield, the risk of error is increased, and the use of cognitive aids (CAs) might be helpful to avoid distraction. We investigated the effect of using a digital CA (MAX, for Medical Assistance eXpert) by combat casualty care providers on their technical and nontechnical performances during the early management of simulated war wounds, compared to their memory and training alone.
MATERIALS AND METHODS


We conducted a randomized, controlled, unblinded study between July 2016 and February 2017. This study was approved by the Ethics Committee of the Ethical Board of Desgenettes Army Training Hospital (14.06.2017 n°385) and was registered on clinicaltrials.gov (NCT03483727). It took place during medicalization training in hostile environment (""MEDICHOS"") in Chamonix Mont-Blanc and in the first aid training center in La Valbonne military base (France). Each participant had to deal with two different scenarios, one with MAX (MAX+) and the other without (MAX-). Scenarios were held using either high-fidelity patient simulators or actors as wounded patients. The primary outcome was participants' technical performance rated as their adherence to the MARCHE RYAN procedure (maximum 100%). The secondary outcome was the nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42).
RESULTS


Technical performance was significantly higher in the MAX+ scenarios (70.60 IQR [63.70-73.56] than in the MAX- scenarios (56.25 IQR [52.88-62.09], p = 0.002). The Ottawa scores were significantly higher in the MAX+ scenarios (31.50 IQR [29.50-33.75]) than in the MAX- scenarios (29.50 IQR [24.50-32.00], p = 0.031).
CONCLUSIONS


The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises. Following recommendations on the design and use of CA, regular team training would improve fluidity in the use and acceptance of an aid, by a highly drilled professional corporation with a strong culture of leadership. Digital CA should be tested at a larger scale in order to validate their contribution to real combat casualty care.",2020,The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises.,['July 2016 and February 2017'],"['CA, regular team training', 'MAX (MAX+) and the other without (MAX', 'cognitive aids (CAs', 'digital CA (MAX, for Medical Assistance eXpert', 'Digital Cognitive Aid']","['nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42', 'Technical performance', 'technical performance rated as their adherence to the MARCHE RYAN procedure']",[],"[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0025070', 'cui_str': 'Medical Assistance'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",,0.0500687,The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Truchot', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Balança', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Pierre François', 'Initials': 'PF', 'LastName': 'Wey', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Tazarourte', 'Affiliation': 'Health Services and Performance Research EA74, Université Claude Bernard Lyon1, 43 Boulevard du 11 Novembre 1918, 69100 Villeurbanne, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lecomte', 'Affiliation': 'Emergency Department, Hôpital Cochin, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Le Goff', 'Affiliation': 'Direction de la Médecine des Forces, Bureau Soutien des Activités Opérationnelles, BA 705 - RD 910, 37076 Tour Cedex 02, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Leigh-Smith', 'Affiliation': 'Royal Infirmary of Edinburgh, Emergency Department, 51 Little France Cres, Edinburgh EH16 4SA, Scotland.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Lehot', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmele', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Cejka', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}]",Military medicine,['10.1093/milmed/usz482']
883,32492354,Rationale and Design of ORCHID: A Randomized Placebo-controlled Clinical Trial of Hydroxychloroquine for Adults Hospitalized with COVID-19.,"The ORCHID (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with coronavirus disease (COVID-19). This document provides the rationale and background for the trial and highlights key design features. We discuss five novel challenges to the design and conduct of a large, multicenter, randomized trial during a pandemic, including  1 ) widespread, off-label use of the study drug before the availability of safety and efficacy data;  2 ) the need to adapt traditional procedures for documentation of informed consent during an infectious pandemic;  3 ) developing a flexible and robust Bayesian analysis incorporating significant uncertainty about the disease, outcomes, and treatment;  4 ) obtaining indistinguishable drug and placebo without delaying enrollment; and  5 ) rapidly obtaining administrative and regulatory approvals. Our goals in describing how the ORCHID trial progressed from study conception to enrollment of the first patient in 15 days are to inform the development of other high-quality, multicenter trials targeting COVID-19. We describe lessons learned to improve the efficiency of future clinical trials, particularly in the setting of pandemics. The ORCHID trial will provide high-quality, clinically relevant data on the safety and efficacy of hydroxychloroquine for the treatment of COVID-19 among hospitalized adults.Clinical trial registered with www.clinicaltrials.gov (NCT04332991).",2020,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19.","['patients with symptomatic Disease (ORCHID) trial', 'hospitalized adults', 'adults hospitalized with COVID-19', 'Adults Hospitalized with COVID-19']","['Placebo', 'ORCHID', 'hydroxychloroquine', 'Hydroxychloroquine', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.277733,"The Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) trial is a multicenter, blinded, randomized trial of hydroxychloroquine versus placebo for the treatment of adults hospitalized with COVID-19.","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, and.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Aggarwal', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Chang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eppensteiner', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Filbin', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine and.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Epidemiology and Population Health, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, New York City, New York.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Harrell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Harborview Medical Center, and.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland, Oregon.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Leither', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Cathryn F', 'Initials': 'CF', 'LastName': 'Oldmixon', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lora A', 'Initials': 'LA', 'LastName': 'Reineck', 'Affiliation': 'Division of Lung Diseases, National Heart, Lung and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Ringwood', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle, Washington.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Medicine, and.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield, Massachusetts.'}, {'ForeName': 'Donna K', 'Initials': 'DK', 'LastName': 'Torr', 'Affiliation': 'Department of Pharmacy Services, Vanderbilt University Medical Center, Nashville, Tennessee; and.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center and University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, and.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202005-478SD']
884,3317272,A randomized clinical trial of early hospital discharge and home follow-up of very-low-birth-weight infants.,,1987,,['early hospital discharge and home follow-up of very-low-birth-weight infants'],[],[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}]",[],[],,0.135073,,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brooten', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Butts', 'Affiliation': ''}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Finkler', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bakewell-Sachs', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gibbons', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Delivoria-Papadopoulos', 'Affiliation': ''}]",NLN publications,[]
885,26739268,"Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial.","BACKGROUND


Globally, most strokes occur in low- and middle-income countries, such as India, with many affected people having no or limited access to rehabilitation services. Western models of stroke rehabilitation are often unaffordable in many populations but evidence from systematic reviews of stroke unit care and early supported discharge rehabilitation trials suggest that some components might form the basis of affordable interventions in low-resource settings. We describe the background, history and design of the ATTEND trial, a complex intervention centred on family-led stroke rehabilitation in India.
METHODS/DESIGN


The ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India.
DISCUSSION


The ATTEND trial is testing the effectiveness of a low-cost rehabilitation intervention that could be widely generalizable to other low- and middle-income countries.
TRIAL REGISTRATION


Clinical Trials Registry-India CTRI/2013/04/003557 . Australian New Zealand Clinical Trials Registry ACTRN12613000078752 . Universal Trial Number U1111-1138-6707.",2016,"The ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India.
","['family-led stroke rehabilitation in India', 'Family-led rehabilitation after stroke in India', '1200 patients across 14 hospital sites in India']","['low-cost rehabilitation intervention', 'family-led caregiver-delivered home-based rehabilitation intervention']",[],"[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.382655,"The ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India.
","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alim', 'Affiliation': 'Research and Development, George Institute for Global Health India, Unit 301, Second Floor ANR Centre, Road No 1, Banjara Hills, Hyderabad, Telangana, India. malim@georgeinstitute.org.in.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia. rlindley@georgeinstitute.org.au.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Felix', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India. cfelix@georgeinstitute.org.in.'}, {'ForeName': 'Dorcas Beulah Chandramathy', 'Initials': 'DB', 'LastName': 'Gandhi', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India. dorcasattend@gmail.com.'}, {'ForeName': 'Shweta Jain', 'Initials': 'SJ', 'LastName': 'Verma', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India. sjvmv1947@gmail.com.'}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Tugnawat', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India. deepak.k@iiphh.org.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Syrigapu', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India. anuradha.s@iiphh.org.'}, {'ForeName': 'Craig Stuart', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia. canderson@georgeinstitute.org.au.'}, {'ForeName': 'Ramaprabhu Krishnappa', 'Initials': 'RK', 'LastName': 'Ramamurthy', 'Affiliation': 'Department of Physiotherapy, Father Muller Medical College, Mangalore, India. physioram2002@gmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'University of Glasgow, Glasgow, UK. Peter.Langhorne@glasgow.ac.uk.'}, {'ForeName': 'Gudlavalleti Venkata Satyanarayana', 'Initials': 'GV', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, India. murthy.gvs@iiphh.org.'}, {'ForeName': 'Bindiganavale Ramaswamy', 'Initials': 'BR', 'LastName': 'Shamanna', 'Affiliation': 'School of Medical Sciences, University of Hyderabad, Gachibowli, Hyderabad, India. brsham@gmail.com.'}, {'ForeName': 'Maree Lisa', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia. mhackett@georgeinstitute.org.au.'}, {'ForeName': 'Pallab Kumar', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'Research and Development, George Institute for Global Health India, Unit 301, Second Floor ANR Centre, Road No 1, Banjara Hills, Hyderabad, Telangana, India. pmaulik@georgeinstitute.org.in.'}, {'ForeName': 'Lisa Anne', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, Australia. lisa.harvey@sydney.edu.au.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia. sjan@georgeinstitute.org.'}, {'ForeName': 'Hueiming', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia. hliu@georgeinstitute.org.au.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'University of Nottingham, Nottingham, UK. marion.walker@nottingham.ac.uk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'University of Leeds, Leeds, UK. a.forster@leeds.ac.uk.'}, {'ForeName': 'Jeyaraj Durai', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India. jeyarajpandian@hotmail.com.'}]",Trials,['10.1186/s13063-015-1129-8']
886,31498380,Effect of Immersive Virtual Reality Education Before Chest Radiography on Anxiety and Distress Among Pediatric Patients: A Randomized Clinical Trial.,"Importance


Pediatric patients often encounter anxiety and distress in hospital settings, and virtual reality education, providing a vivid, immersive, and realistic experience, has been introduced to mitigate these anxiety responses.
Objective


To evaluate whether virtual reality education for pediatric patients before chest radiography could reduce anxiety and distress in children and improve the radiographic process.
Design, Setting, and Participants


This prospective randomized clinical trial was conducted in a tertiary academic hospital in Seongnam, Republic of Korea. Participants (n = 112) were children aged 4 to 8 years who underwent chest radiography between July 20, 2018, and September 11, 2018. Analysis was performed from October 2, 2018, to April 23, 2019.
Interventions


Children were randomized to simple verbal instruction (control group) or 3-minute virtual reality education explaining the process of chest radiography in detail and leading to appropriate cooperation (virtual reality group).
Main Outcomes and Measures


The primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed). Secondary outcomes were the need of parental presence, parental satisfaction score, procedure time, number of repeated images, and process difficulty score.
Results


Of 99 children included in the final analysis, 50 (50.5%) were allocated to the control group (mean [SD] age, 5.6 [1.2] years; 26 boys [52.0%]) and 49 (49.5%) to the virtual reality group (mean [SD] age, 5.8 [1.3] years; 32 boys [65.3%]). The mean (SD) score for anxiety and distress (2.0 [3.7] vs 5.0 [6.1]; mean difference, 3.0 [95% CI, 1.0-5.0]; P = .004), need for parental presence (8 cases with parents present [16.3%] vs 18 cases with parents present [36.0%]), and mean (SD) procedure time (55.1 [21.6] seconds vs 75.0 [42.0] seconds) were lower in the virtual reality group than in the control group. The mean (SD) score for parental satisfaction (9.4 [1.4] vs 8.6 [2.0]) was higher in the virtual reality group than in the control group.
Conclusions and Relevance


Virtual reality education before chest radiography improved the radiography experience among pediatric patients by reducing anxiety, distress, and procedure time while increasing parents' satisfaction.
Trial Registration


UMIN Clinical Trials Registry: UMIN000030663.",2019,"The primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed).","['Interventions\n\n\nChildren', 'Pediatric Patients', '99 children included in the final analysis, 50 (50.5%) were allocated to the control group (mean [SD] age, 5.6 [1.2] years; 26 boys [52.0%]) and 49 (49.5%) to the virtual reality group (mean [SD] age, 5.8 [1.3] years; 32 boys [65.3', 'pediatric patients', 'pediatric patients before chest', 'Participants (n\u2009', 'tertiary academic hospital in Seongnam, Republic of Korea', '112) were children aged 4 to 8 years who underwent chest radiography between July 20, 2018, and September 11, 2018']","['simple verbal instruction (control group) or 3-minute virtual reality education explaining the process of chest radiography in detail and leading to appropriate cooperation (virtual reality group', 'Immersive Virtual Reality Education Before Chest Radiography', 'virtual reality education', 'radiography']","['mean (SD) procedure time', 'mean (SD) score for parental satisfaction', 'behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed', 'anxiety and distress', 'Anxiety and Distress', 'need of parental presence, parental satisfaction score, procedure time, number of repeated images, and process difficulty score', 'mean (SD) score for anxiety and distress']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558039', 'cui_str': 'Behavior Observation'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0222045'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",99.0,0.0928754,"The primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed).","[{'ForeName': 'Sung-Hee', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Gwanak-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Gwanak-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Il', 'Initials': 'SI', 'LastName': 'Choi', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyunju', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Hee-Jeong', 'Initials': 'HJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Psychiatry, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Medical Virtual Reality Research Group, Seoul National University College of Medicine, Gwanak-gu, Seoul, Republic of Korea.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.3000']
887,31259608,Day of Ascent Dosing of Acetazolamide for Prevention of Acute Mountain Sickness.,"Background:  Acetazolamide is the most common medication used for prevention of acute mountain sickness (AMS), usually administered the day or night before ascent. The objective of this study was to evaluate the efficacy of day of ascent dosing of acetazolamide for AMS prevention.  Methods:  Double-blind, randomized, controlled noninferiority trial of acetazolamide 125 mg twice daily beginning either the night before or the morning of ascent. Healthy low altitude adults ascended from 1240 m (4100 ft) to 3810 m (12,570 ft) during summer 2018 on White Mountain, California. Primary outcome was incidence of AMS with the two different dosing patterns, assessed by the 1993 Lake Louise Questionnaire (LLQ) of ≥3 with headache and a minimum of 1 for other symptom.  Results:  One hundred four participants completed the study, with 54 (52%) randomized to night before acetazolamide and 50 (48%) to day of ascent dosing, without differences in baseline characteristics. There was 9% greater incidence of AMS in the day of ascent acetazolamide group (48.0% vs. 39%, 95% confidence interval [CI] -11.8 to 30,  p  = 0.46, number needed to treat [NNT] = 5.6 vs. 3.7), with the CI just surpassing the predetermined 26% noninferiority margin. There was a lower incidence of severe AMS (1993 LLQ >5) in the day of ascent group ( n  = 5, 10%, NNT = 2.3) compared with night before dosing ( n  = 12, 22%, NNT = 3.1) (95% CI -28 to 3.6), and lower average symptom severity in the day of ascent group (3 vs. 3.5, 95% CI -0.5 to 1.4).  Conclusions:  Day of ascent acetazolamide demonstrated higher rates of AMS compared with traditional dosing by a small margin. With similar rates of severe AMS and overall symptom severity, the potential for improved convenience and compliance may support day of ascent use.",2019,"There was a lower incidence of severe AMS (1993 LLQ >5) in the day of ascent group ( n  = 5, 10%, NNT = 2.3) compared with night before dosing ( n  = 12, 22%, NNT = 3.1) (95% CI -28 to 3.6), and lower average symptom severity in the day of ascent group (3 vs. 3.5, 95% CI -0.5 to 1.4).  ","['Healthy low altitude adults ascended from 1240\u2009m (4100 ft) to 3810\u2009m (12,570 ft) during summer 2018 on White Mountain, California', 'One hundred four participants completed the study, with 54 (52%) randomized to night before', 'Acute Mountain Sickness']","['Acetazolamide', 'acetazolamide', 'High Alt Med Biol']","['incidence of AMS', 'incidence of AMS with the two different dosing patterns, assessed by the 1993 Lake Louise Questionnaire (LLQ) of ≥3 with headache and a minimum of 1 for other symptom', 'rates of AMS', 'severe AMS', 'average symptom severity', 'severe AMS and overall symptom severity']","[{'cui': 'C0238618', 'cui_str': 'Low altitude (physical force)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness (disorder)'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0337049', 'cui_str': 'Lakes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",104.0,0.108389,"There was a lower incidence of severe AMS (1993 LLQ >5) in the day of ascent group ( n  = 5, 10%, NNT = 2.3) compared with night before dosing ( n  = 12, 22%, NNT = 3.1) (95% CI -28 to 3.6), and lower average symptom severity in the day of ascent group (3 vs. 3.5, 95% CI -0.5 to 1.4).  ","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Lipman', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Jurkiewicz', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Winstead-Derlega', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Navlyt', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Burns', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Computational Science, University of Colorado, Boulder, Boulder, Colorado.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Reilly', 'Affiliation': 'Department of Emergency Medicine, University of New Mexico School of Medicine, Albuquerque, New Mexico.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Burnier', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Keiran', 'Initials': 'K', 'LastName': 'Warner', 'Affiliation': 'Stanford University Emergency Medicine Residency, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hackett', 'Affiliation': 'Altitude Research Center, Department of Emergency Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}]",High altitude medicine & biology,['10.1089/ham.2019.0007']
888,31560227,Effects of a Laxation and Probiotic Bowel Preparation Regimen: A Randomized Controlled Trial in Patients Undergoing Prostate Radiation Therapy.,"Aim : To determine the effect of bulking and osmotic laxation regimens on reducing rectal gas in patients receiving external beam radiation therapy for prostate cancer. Methods:  A single blinded randomized controlled trial was conducted. Participants assigned to the intervention group (IG) were instructed to consume a bulking laxative and probiotic and the standard care group (SC) instructed to consume an osmotic laxative. Both groups followed a standard low gas diet. Rectal gas ratings were determined from cone-beam computed tomography (CBCT) scans. Dietary and laxative compliance, bowel habits, fiber and fluid intakes were determined from food diaries. Results:  Demographic characteristics were not significantly different between the two treatment arms. The mean age was 74 years. Participants were randomized into the IG ( n  = 8) and SC group ( n  = 9). Analysis of 433 CBCT scans indicate the odds of a higher rectal gas rating were significantly increased for the IG compared with the SC group (OR 3.2, 95% CI 1.77-5.78,  P  < 0.001). Conclusions:  The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study. Larger studies of commonly used laxatives are required to develop recommendations for bowel preparation during radiotherapy to the prostate.",2020,The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study.,"['Patients Undergoing Prostate Radiation Therapy', 'patients receiving external beam radiation therapy for prostate cancer', 'The mean age was 74\u2009years']","['intervention group (IG) were instructed to consume a bulking laxative and probiotic and the standard care group (SC) instructed to consume an osmotic laxative', 'bulking and osmotic laxation regimens', 'Laxation and Probiotic Bowel Preparation Regimen']","['higher rectal gas rating', 'Demographic characteristics', 'Rectal gas ratings', 'Dietary and laxative compliance, bowel habits, fiber and fluid intakes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1955900', 'cui_str': 'Bulk Laxatives'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0353980', 'cui_str': 'Osmotic laxatives (product)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0282090', 'cui_str': 'Laxatives'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake (observable entity)'}]",,0.113742,The osmotic laxative was more effective at achieving lower rectal gas levels than a bulking laxative with probiotic in this study.,"[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Weston', 'Affiliation': 'Central West Cancer Care Centre, Orange Health Service, Orange, NSW, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Luscombe', 'Affiliation': 'The School of Rural Health, Sydney Medical School, The University of Sydney, Orange, NSW, Australia.'}, {'ForeName': 'Kerith', 'Initials': 'K', 'LastName': 'Duncanson', 'Affiliation': 'Health Education and Training Institute, The Junction, NSW, Australia.'}]",Nutrition and cancer,['10.1080/01635581.2019.1669675']
889,32091548,"Effect of High-Dose vs Standard-Dose Vitamin D Supplementation in Pregnancy on Bone Mineralization in Offspring Until Age 6 Years: A Prespecified Secondary Analysis of a Double-Blinded, Randomized Clinical Trial.","Importance


Studies suggest an association between maternal vitamin D status during pregnancy and offspring anthropometry and bone mineralization, but investigations are few and with mixed results.
Objective


To investigate the effect of a high dose vs standard dose of vitamin D supplementation in pregnancy on anthropometric and bone outcomes until age 6 years in the offspring.
Design, Setting, and Participants


A prespecified analysis of a double-blinded, randomized clinical trial in the Copenhagen Prospective Studies on Asthma in Childhood 2010 mother-child cohort that included 623 pregnant mothers and their 584 children. Data were analyzed between January 2019 and September 2019.
Interventions


Vitamin D supplementation of 2800 IU/d (high-dose) vs 400 IU/d (standard-dose) from pregnancy week 24 until 1 week after birth.
Main Outcomes and Measures


Longitudinal anthropometry assessments including length/height, weight, and body mass index until age 6 years and bone mineral content (BMC) and bone mineral density (BMD) at age 3 years and 6 years from dual-energy radiography absorptiometry scans.
Results


At age 6 years, 517 children (89%) completed the clinical follow-up. All participants were Danish and white; 261 were boys and 256 were girls. A mixed-effects model analysis of dual-energy radiography absorptiometry scan outcomes from ages 3 years and 6 years showed that children in the vitamin D vs placebo group had higher whole-body BMC: mean difference adjusted (aMD) for age, sex, height, and weight was 11.5 g (95% CI, 2.3-20.7; P = .01); higher whole-body-less-head BMC aMD was 7.5 g (95% CI, 1.5-13.5; P = .01); and higher head BMD aMD was 0.023 g/cm2 (95% CI, 0.003-0.004; P = .03). The largest effect was in children from vitamin D-insufficient mothers (<30 ng/mL; to convert to nanomoles per liter, multiply by 2.496) and among winter births. In a post hoc analysis, we found borderline lower incidence of fractures in the vitamin D group (n = 23 vs n = 36; incidence rate ratio, 0.62 [95% CI, 0.37-1.05]; P = .08), but no differences in any anthropometric outcomes. Adjustment for a concomitant ω-3 polyunsaturated fatty acids intervention did not change the results.
Conclusions and Relevance


High-dose vitamin D supplementation in pregnancy improved offspring bone mineralization through age 6 years compared with the standard dose, suggesting an increased recommended gestational intake, which may influence peak bone mass, fracture risk, and risk of osteoporosis later in life. We found no supplementation effect on anthropometric outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT00856947.",2020,"n = 36; incidence rate ratio, 0.62 [95% CI, 0.37-1.05]; P = .08), but no differences in any anthropometric outcomes.","['Offspring Until Age 6 Years', 'pregnancy on anthropometric and bone outcomes until age 6 years in the offspring', 'All participants were Danish and white; 261 were boys and 256 were girls', 'At age 6 years, 517 children (89%) completed the clinical follow-up', 'Childhood 2010 mother-child cohort that included 623 pregnant mothers and their 584 children']","['ω-3 polyunsaturated fatty acids intervention', 'vitamin D supplementation', 'vitamin D vs placebo', 'Vitamin D supplementation', 'vitamin D', 'High-Dose vs Standard-Dose Vitamin D Supplementation']","['Measures\n\n\nLongitudinal anthropometry assessments including length/height, weight, and body mass index until age 6 years and bone mineral content (BMC) and bone mineral density (BMD) at age 3 years and 6 years from dual-energy radiography absorptiometry scans', 'head BMD aMD', 'Bone Mineralization']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0441633'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C2350989', 'cui_str': 'Bone Mineralization'}]",584.0,0.47793,"n = 36; incidence rate ratio, 0.62 [95% CI, 0.37-1.05]; P = .08), but no differences in any anthropometric outcomes.","[{'ForeName': 'Nicklas', 'Initials': 'N', 'LastName': 'Brustad', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Garland', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Thorsen', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Sevelsted', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krakauer', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Vinding', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Stokholm', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Bønnelykke', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Bisgaard', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bo L', 'Initials': 'BL', 'LastName': 'Chawes', 'Affiliation': 'Copenhagen Prospective Studies on Asthma in Childhood, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.6083']
890,31907649,Is Xbox 360 Kinect-based virtual reality training as effective as standard physiotherapy in patients undergoing breast cancer surgery?,"PURPOSE


Breast cancer surgery may be associated with pain and physical symptoms in the upper limbs. Functional impairment and pain-related avoidance of movement may further increase disability level. This study aimed to investigate the potential effects of early postoperative virtual reality (VR) therapy on pain, range of motion (ROM), muscle strength, functionality, and fear of movement.
METHODS


Forty women with breast cancer who had undergone unilateral mastectomy with axillary lymph node dissection and who were receiving adjuvant therapy were included in the study and randomly assigned to two groups: the Kinect-based rehabilitation group (KBRG) and the standardized physical therapy group (SPTG). The KBRG (n = 20) received VR therapy using Xbox Kinect-based games and the SPTG (n = 20) received standard physiotherapy. Study subjects were assessed at baseline and after the 6-week treatment. Outcome measures were pain (visual analogue scale), grip strength (dynamometer), functionality (disabilities of the arm shoulder and hand questionnaire), muscle strength (handheld dynamometer), ROM (digital goniometer), and fear of movement (Tampa kinesiophobia scale (TKS)).
RESULTS


Both groups detected significant changes in pain, ROM, muscle strength, grip strength, functionality, and TKS scores after the treatment (p < 0.01). Fear of movement was significantly improved in the KBRG and the SPTG displayed more improvement in functionality (p < 0.05). There were no differences in ROM, muscle strength, grip strength, and pain between the groups after the treatment (p > 0.05).
CONCLUSION


Kinect-based VR therapy resulted in significant outcomes that were comparable to those obtained under standard physiotherapy in the early postoperative phase in patients who had undergone breast cancer surgery.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov ( ClinicalTrials.gov identifier: NCT03618433).",2020,"Both groups detected significant changes in pain, ROM, muscle strength, grip strength, functionality, and TKS scores after the treatment (p < 0.01).","['Forty women with breast cancer who had undergone unilateral mastectomy with axillary lymph node dissection and who were receiving', 'patients undergoing breast cancer surgery', 'patients who had undergone breast cancer surgery']","['adjuvant therapy', 'Kinect-based VR therapy', 'standard physiotherapy', 'VR therapy using Xbox Kinect-based games and the SPTG', 'KBRG', 'Kinect-based rehabilitation group (KBRG) and the standardized physical therapy group (SPTG', 'Xbox 360 Kinect-based virtual reality training', 'early postoperative virtual reality (VR) therapy']","['pain, ROM, muscle strength, grip strength, functionality, and TKS scores', 'Fear of movement', 'ROM, muscle strength, grip strength, and pain', 'pain and physical symptoms', 'pain, range of motion (ROM), muscle strength, functionality, and fear of movement', 'pain (visual analogue scale), grip strength (dynamometer), functionality (disabilities of the arm shoulder and hand questionnaire), muscle strength (handheld dynamometer), ROM (digital goniometer), and fear of movement (Tampa kinesiophobia scale (TKS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3494470', 'cui_str': 'Virtual Reality Immersion Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2919270', 'cui_str': 'Disabilities of the arm, shoulder and hand outcome measurement'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0222045'}]",40.0,0.0550651,"Both groups detected significant changes in pain, ROM, muscle strength, grip strength, functionality, and TKS scores after the treatment (p < 0.01).","[{'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Feyzioğlu', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey. ozlem.feyzioglu@acibadem.edu.tr.'}, {'ForeName': 'Selvi', 'Initials': 'S', 'LastName': 'Dinçer', 'Affiliation': 'Department of Radiation Oncology, Ministry of Health Okmeydanı Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Akan', 'Affiliation': 'Department of Breast and Endocrine Surgery, Ministry of Health Okmeydanı Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Zeliha Candan', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': 'Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Istanbul Medipol University, Istanbul, Turkey.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05287-x']
891,30459099,"The effects of vitamin D and probiotic co-supplementation on glucose homeostasis, inflammation, oxidative stress and pregnancy outcomes in gestational diabetes: A randomized, double-blind, placebo-controlled trial.","BACKGROUND AND AIMS


This study was designed to assess the effects of combined vitamin D and probiotic supplementation on metabolic status and pregnancy outcomes in women with gestational diabetes (GDM).
METHODS


This randomized, double-blind, placebo-controlled clinical trial was performed in 87 women with GDM. Patients were randomly assigned three groups to receive either vitamin D (50,000 IU/every 2 weeks) plus probiotic (8 × 10 9  CFU/day) (n = 30), probiotic (8 × 10 9  CFU/day) (n = 29) or placebo (n = 28) for 6 weeks.
RESULTS


Vitamin D and probiotic co-supplementation significantly reduced fasting plasma glucose (β -10.99 mg/dL; 95% CI, -14.26, -7.73; P < 0.001), serum insulin levels (β -1.95 μIU/mL; 95% CI, -3.05, -0.84; P = 0.001) and homeostasis model of assessment-insulin resistance (β -0.76; 95% CI, -1.06, -0.45; P < 0.001), and significantly increased the quantitative insulin sensitivity check index (β 0.01; 95% CI, 0.008, 0.03; P = 0.001) compared with the placebo. In addition, vitamin D and probiotic co-supplementation resulted in a significant reduction in triglycerides (β -37.56 mg/dL; 95% CI, -51.55, -23.56; P < 0.001), VLDL- (β -7.51 mg/dL; 95% CI, -10.31, -4.71; P < 0.001), HDL-/total cholesterol ratio (β -0.52; 95% CI, -0.79, -0.24; P < 0.001), high sensitivity C-reactive protein (β -1.80 mg/L; 95% CI, -2.53, -1.08; P < 0.001) and malondialdehyde (β -0.43 μmol/L; 95% CI, -0.77, -0.09; P = 0.01); also, a significant rise in HDL-cholesterol (β 4.09 mg/dL; 95% CI, 1.11, 7.08; P = 0.008) and total antioxidant capacity (TAC) levels (β 97.77 mmol/L; 95% CI, 52.34, 143.19; P < 0.001) were observed compared with the placebo. Vitamin D and probiotic co-supplementation did not change other metabolic parameters. Vitamin D and probiotic co-supplementation significantly decreased triglycerides (P = 0.02), VLDL-cholesterol (P = 0.02) and hs-CRP (P = 0.01), and significantly increased TAC (P = 0.006) and total glutathione levels (P = 0.04) compared with only probiotic group.
CONCLUSIONS


In conclusion, vitamin D and probiotic co-supplementation in women with GDM had beneficial effects on metabolic status. This trial was registered at www.irct.ir as IRCT201706075623N119.",2019,co-supplementation significantly reduced fasting plasma glucose (β -10.99 ,"['women with gestational diabetes (GDM', 'women with GDM', 'gestational diabetes', '87 women with GDM', '37.56']","['vitamin D', 'placebo', 'Vitamin D and probiotic', 'Vitamin D and probiotic co-supplementation', 'combined vitamin D and probiotic supplementation', 'vitamin D and probiotic co-supplementation']","['triglycerides', 'triglycerides ', 'homeostasis model of assessment-insulin resistance', 'VLDL-cholesterol', 'total glutathione levels', 'high sensitivity C-reactive protein ', 'metabolic status and pregnancy outcomes', 'serum insulin levels', 'quantitative insulin sensitivity check index', 'HDL-/total cholesterol ratio', 'metabolic status', 'HDL-cholesterol', 'total antioxidant capacity (TAC) levels', 'TAC', 'VLDL- (β', 'glucose homeostasis, inflammation, oxidative stress and pregnancy outcomes', 'metabolic parameters', 'fasting plasma glucose']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",87.0,0.804558,co-supplementation significantly reduced fasting plasma glucose (β -10.99 ,"[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Endocrinology and Metabolism Research Center, Department of Gynecology and Obstetrics, School of Medicine, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: asemi_r@yahoo.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.10.028']
892,30497695,A randomized controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing elective craniotomy.,"OBJECT


The aim of this study was to evaluate the effect of preoperative oral carbohydrate loading versus fasting on the outcomes of patients undergoing elective craniotomy.
METHODS


In a single-center randomized controlled study, 120 neurosurgical patients who were admitted for elective craniotomy were included and randomized into 2 groups: 58 patients received 400 mL of oral carbohydrate loading 2 h before surgery (intervention group), and 62 patients were fasting for 8 h prior to surgery as routine management (control group). The primary end point was glucose homeostasis. Secondary outcomes included handgrip strength, pulmonary function and postoperative complications.
RESULTS


Better glucose homeostasis (5.6 ± 1.0 mmol/L vs. 6.3 ± 1.2 mmol/L, P = 0.001) was achieved in patients who received preoperative oral carbohydrate loading compared to fasting. Furthermore, patients in the intervention group had better handgrip strength (25.3 ± 7.1 kg vs. 19.9 ± 7.5 kg, P < 0.0001) and pulmonary function (in terms of peak expiratory flow rate) (315.8 ± 91.5 L/min vs. 270.0 ± 102.7 L/min, P = 0.036) compared to the controls postoperatively. The rates of postoperative surgical and non-surgical complications did not differ between the groups. Both postoperative and total hospital length of stay (LOS) reduced significantly in the intervention group (-3d, P < 0.0001 and P = 0.004).
CONCLUSIONS


Oral carbohydrate loading given 2 h before surgery in patients undergoing elective craniotomy seems to improve glucose homeostasis, handgrip strength and pulmonary function as well as decrease LOS without increasing the risk of postoperative complications. Routine use of preoperative oral carbohydrate loading could be suggested in clinical settings, though further evaluation of its safety and efficacy is warranted.",2019,"Both postoperative and total hospital length of stay (LOS) reduced significantly in the intervention group (-3d, P ","['patients undergoing elective craniotomy', '120 neurosurgical patients who were admitted for elective craniotomy']","['Oral carbohydrate loading', 'preoperative oral carbohydrate loading versus fasting', '400\xa0mL of oral carbohydrate loading 2\xa0h before surgery (intervention group), and 62 patients were fasting for 8\xa0h prior to surgery as routine management (control group']","['postoperative and total hospital length of stay (LOS', 'glucose homeostasis, handgrip strength and pulmonary function', 'pulmonary function', 'rates of postoperative surgical and non-surgical complications', 'handgrip strength', 'handgrip strength, pulmonary function and postoperative complications', 'glucose homeostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",120.0,0.0321879,"Both postoperative and total hospital length of stay (LOS) reduced significantly in the intervention group (-3d, P ","[{'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China; Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Tianzhi', 'Initials': 'T', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Binfang', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': ""Department of Nutrition, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Lanfu', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Wenhai', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yingxi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Zhengmin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Nutrition, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Nutrition, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Xude', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China; Department of Neurosurgery, Xi'an International Medical Center, Xi'an, Shaanxi Province, China. Electronic address: he-shiming@163.com.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.11.008']
893,31550363,Real-World Effectiveness From the Asia Pacific Rim Liver Consortium for HBV Risk Score for the Prediction of Hepatocellular Carcinoma in Chronic Hepatitis B Patients Treated With Oral Antiviral Therapy.,"BACKGROUND


Patients on oral antiviral (OAV) therapy remain at hepatocellular carcinoma (HCC) risk. Risk prediction tools distinguishing treated patients with residual HCC risk are limited. The aim of this study was to develop an accurate, precise, simple-to-use HCC risk score using routine clinical variables among a treated Asian cohort.
METHODS


Adult Asian chronic hepatitis B (CHB) patients on OAV were recruited from 25 centers in the United States and the Asia-Pacific region. Excluded persons were coinfected with hepatitis C, D, or human immunodeficiency virus, had HCC before or within 1 year of study entry, or their follow-up was <1 year. Patients were randomized to derivation and validation cohorts on a 2:1 ratio. Statistically significant predictors from multivariate modeling formed the Real-world Effectiveness from the Asia Pacific Rim Liver Consortium for HBV (REAL-B) score.
RESULTS


A total of 8048 patients were randomized to the derivation (n = 5365) or validation group (n = 2683). The REAL-B model included 7 variables (male gender, age, alcohol use, diabetes, baseline cirrhosis, platelet count, and alpha fetoprotein), and scores were categorized as follows: 0-3 low risk, 4-7 moderate risk, and 8-13 high risk. Area under receiver operating characteristics were >0.80 for HCC risk at 3, 5, and 10 years, and these were significantly higher than other risk models (p < .001).
CONCLUSIONS


The REAL-B score provides 3 distinct risk categories for HCC development in Asian CHB patients on OAV guiding HCC surveillance strategy.",2020,"AUROCs were >0.80 for HCC risk at 3, 5, and 10 years, and were significantly higher than other risk models (p<0·001).
","['Excluded persons were co-infected with hepatitis C, D, or HIV, had HCC prior to or within 1 year of study entry or their follow-up was <1 year', 'treated Asian cohort', 'Asian CHB patients', 'patients with residual HCC risk', 'Routine practice adult Asian CHB patients on OAV were recruited from 25 centers in the US and Asia-Pacific region', 'Asia Pacific Rim Liver Consortium for HBV', '8,048 patients were randomized to the derivation (n=5,365) or validation group (n=2,683).The REAL-B model included 7 variables (male gender, age, alcohol use, diabetes, baseline cirrhosis, platelet count, and AFP) scores were categorized as: 0-3 low risk, 4-7 moderate risk, and 8-13 high risk', 'Patients on oral antiviral (OAV) therapy remain at HCC risk']",['Oral Antiviral Therapy'],['REAL-B '],"[{'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0556630', 'cui_str': 'Anal penetration using tongue (finding)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy (procedure)'}]",[],,0.0341628,"AUROCs were >0.80 for HCC risk at 3, 5, and 10 years, and were significantly higher than other risk models (p<0·001).
","[{'ForeName': 'Hwai-I', 'Initials': 'HI', 'LastName': 'Yang', 'Affiliation': 'Genomics Research Center, Academia Sinica, Taipei, Taiwan.'}, {'ForeName': 'Ming-Lun', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Wong', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Peng', 'Affiliation': 'Department of Gastroenterology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Huy N', 'Initials': 'HN', 'LastName': 'Trinh', 'Affiliation': 'San Jose Gastroenterology, San Jose, California, USA.'}, {'ForeName': 'Ka-Shing', 'Initials': 'KS', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': ""Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Peopole's Republic of China.""}, {'ForeName': 'Tung-Hung', 'Initials': 'TH', 'LastName': 'Su', 'Affiliation': 'Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ritsuzo', 'Initials': 'R', 'LastName': 'Kozuka', 'Affiliation': 'Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology, Good Gang-An Hospital, Busan, South Korea.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Ogawa', 'Affiliation': 'Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, Peopole's Republic of China.""}, {'ForeName': 'Hui-Bin', 'Initials': 'HB', 'LastName': 'Ning', 'Affiliation': ""Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Peopole's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Department of Infectious Diseases, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu, Peopole's Republic of China.""}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Palo Alto Medical Foundation, Mountain View Division, Mountain View, California, USA.'}, {'ForeName': 'Jian Q', 'Initials': 'JQ', 'LastName': 'Zhang', 'Affiliation': 'Chinese Hospital, San Francisco, California, USA.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ide', 'Affiliation': 'Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Huichun', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""Beijing Ditan Hospital, Capital Medical University, Beijing, Peopole's Republic of China.""}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Iwane', 'Affiliation': 'Department of Internal Medicine, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Internal Medicine, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Wong Clinics, San Francisco, California, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Wong Clinics, San Francisco, California, USA.'}, {'ForeName': 'Chia-Hsin', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Hoang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Le', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Henry', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Toyoda', 'Affiliation': 'Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterology, Yamagata University, Yamagata, Japan.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Gane', 'Affiliation': 'Liver Transplant Unit, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Internal Medicine, Saga University Hospital, Saga, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kurosaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Infectious Diseases, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu, Peopole's Republic of China.""}, {'ForeName': 'Chenghai', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, Peopole's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Shang', 'Affiliation': ""Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Peopole's Republic of China.""}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Furusyo', 'Affiliation': 'Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Enomoto', 'Affiliation': 'Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Jia-Horng', 'Initials': 'JH', 'LastName': 'Kao', 'Affiliation': 'Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Man-Fung', 'Initials': 'MF', 'LastName': 'Yuen', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ming-Lung', 'Initials': 'ML', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Mindie H', 'Initials': 'MH', 'LastName': 'Nguyen', 'Affiliation': 'Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, California, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz477']
894,32492293,A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19.,"BACKGROUND


Coronavirus disease 2019 (Covid-19) occurs after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For persons who are exposed, the standard of care is observation and quarantine. Whether hydroxychloroquine can prevent symptomatic infection after SARS-CoV-2 exposure is unknown.
METHODS


We conducted a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis. We enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Within 4 days after exposure, we randomly assigned participants to receive either placebo or hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days). The primary outcome was the incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days.
RESULTS


We enrolled 821 asymptomatic participants. Overall, 87.6% of the participants (719 of 821) reported a high-risk exposure to a confirmed Covid-19 contact. The incidence of new illness compatible with Covid-19 did not differ significantly between participants receiving hydroxychloroquine (49 of 414 [11.8%]) and those receiving placebo (58 of 407 [14.3%]); the absolute difference was -2.4 percentage points (95% confidence interval, -7.0 to 2.2; P = 0.35). Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
CONCLUSIONS


After high-risk or moderate-risk exposure to Covid-19, hydroxychloroquine did not prevent illness compatible with Covid-19 or confirmed infection when used as postexposure prophylaxis within 4 days after exposure. (Funded by David Baszucki and Jan Ellison Baszucki and others; ClinicalTrials.gov number, NCT04308668.).",2020,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","['United States and parts of Canada testing', '821 asymptomatic participants', 'enrolled adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure']","['placebo', 'Hydroxychloroquine', 'placebo or hydroxychloroquine', 'hydroxychloroquine']","['Side effects', 'incidence of new illness compatible with Covid-19', 'incidence of either laboratory-confirmed Covid-19 or illness compatible with Covid-19 within 14 days', 'serious adverse reactions']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0454979', 'cui_str': 'Part of Canada'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0028798', 'cui_str': 'Exposure, Occupational'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",821.0,0.751633,"Side effects were more common with hydroxychloroquine than with placebo (40.1% vs. 16.8%), but no serious adverse reactions were reported.
","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Alanna A', 'Initials': 'AA', 'LastName': 'Nascene', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Nicol', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole W', 'Initials': 'NW', 'LastName': 'Engen', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'LaBar', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Ilan S', 'Initials': 'IS', 'LastName': 'Schwartz', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'From the University of Minnesota (D.R.B., M.F.P., A.S.B., K.A.P., S.M.L., E.C.O., C.P.S., A.A.N., M.R.N., M.A., N.W.E., R.R., K.H.H.) and M Health Fairview Investigational Drug Service Pharmacy (D.L.), Minneapolis; and the Research Institute of the McGill University Health Centre and the Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal (M.P.C., E.G.M., T.C.L.), the Department of Internal Medicine, University of Manitoba (S.A.L., L.J.M., G.D., N.M., R.Z.), the Research Institute in Oncology and Hematology, CancerCare Manitoba, University of Manitoba (R.Z.), and the George and Fay Yee Centre for Healthcare Innovation (L.E.K.), Winnipeg, and the University of Alberta, Edmonton (I.S.S.) - all in Canada.'}]",The New England journal of medicine,['10.1056/NEJMoa2016638']
895,30884661,Probiotic potential of a Lactobacillus rhamnosus cheese isolate and its effect on the fecal microbiota of healthy volunteers.,"The present study describes an in vitro characterization of strains of lactic acid bacteria, focusing on physiological characters of probiotic interest, and a subsequent placebo-controlled, crossover administration trial, with a cohort of healthy volunteers. The strains of lactic acid bacteria were previously isolated from a fermented food (ripened cheese) and several ones resulted to have promising probiotic characteristics. Based on comprehensive evaluation of the data obtained, one strain was chosen and supplemented in a fermented milk. The fermented milk was then used in the administration trial with the goal of assessing its effect on the composition of the intestinal microbiota, as reflected in the feces. The fermented milk, with or without probiotic, had an effect on the intestinal microbiota and significant inter-individual differences were observed in response to the intervention. A common trend was observed related to two important populations of the human gut microbiota; a reduction in the relative abundance of Bacteroides and increase in the abundance of Prevotella in subjects during treatment compared to baseline were registered.",2019,"The fermented milk, with or without probiotic, had an effect on the intestinal microbiota and significant inter-individual differences were observed in response to the intervention.",['healthy volunteers'],[],"['intestinal microbiota', 'fecal microbiota']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",,0.0346137,"The fermented milk, with or without probiotic, had an effect on the intestinal microbiota and significant inter-individual differences were observed in response to the intervention.","[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Bautista-Gallego', 'Affiliation': 'Food Biotechnology Department, Instituto de la Grasa, Consejo Superior de Investigaciones Científicas, Universidad Pablo de Olavide, Seville, Spain.'}, {'ForeName': 'Ilario', 'Initials': 'I', 'LastName': 'Ferrocino', 'Affiliation': 'Department of Agricultural, Forest and Food Sciences, University of Torino, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Botta', 'Affiliation': 'Department of Agricultural, Forest and Food Sciences, University of Torino, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Departmentof Agricultural Sciences, University of Naples ""Federico II"", Italy; Task Force on Microbiome Studies, University of Naples ""Federico II"", Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cocolin', 'Affiliation': 'Department of Agricultural, Forest and Food Sciences, University of Torino, Italy.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Rantsiou', 'Affiliation': 'Department of Agricultural, Forest and Food Sciences, University of Torino, Italy. Electronic address: kalliopi.rantsiou@unito.it.'}]","Food research international (Ottawa, Ont.)",['10.1016/j.foodres.2019.02.004']
896,32416145,Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.,"OBJECTIVE


To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism.
STUDY DESIGN


We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.
RESULTS


Sixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.
CONCLUSIONS


Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use.
IMPLICATIONS


A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.",2020,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"['Sixty-five participants enrolled in E2 75 (n=22), 100 (n=21), and 200 (n=22) mcg/day groups; 35 participated in the substudy', 'healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups']","['contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate', '90-day contraceptive vaginal ring releasing estradiol and segesterone acetate', '2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information', 'segesterone acetate (SA']","['zero median unscheduled bleeding or spotting days', 'withdrawal bleeding', 'median E2 concentrations', 'Median serum E2 concentrations', 'serum estradiol (E2) concentrations', 'zero median unscheduled bleeding']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439426', 'cui_str': 'ug/day'}, {'cui': 'C4723383', 'cui_str': 'Segesterone acetate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152010', 'cui_str': 'Withdrawal bleeding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",65.0,0.194795,Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL.,"[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States. Electronic address: mejchen@ucdavis.edu.'}, {'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': 'Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States.'}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Carolyn L', 'Initials': 'CL', 'LastName': 'Westhoff', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, NY, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Thomas', 'Affiliation': 'Reproductive Medicine Research, Department of Obstetrics and Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Jensen', 'Affiliation': 'Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Variano', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Sitruk-Ware', 'Affiliation': 'Center for Biomedical Research, Population Council, New York, NY, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Health Decisions, Durham, NC, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Blithe', 'Affiliation': 'Contraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, United States.'}]",Contraception,['10.1016/j.contraception.2020.05.004']
897,31560971,Acceptability and Efficacy of a Sexual Health Texting Intervention Designed to Support Adolescent Females.,"OBJECTIVE


To evaluate the feasibility, acceptability, and initial efficacy of a pilot texting intervention (""t4she"") in primary care designed to increase sexual health knowledge and promote dual protection strategies to reduce unintended pregnancies and sexually transmitted infections among adolescent females.
METHODS


Participants were recruited from 2 federally qualified health centers. Eligibility included: being 13 to 18 years of age; assigned female at birth; English-speaking; not currently pregnant and/or intending to become pregnant; and having texting capabilities. A randomized controlled trial assessed between-group differences at 3 and 6 months on knowledge, Health Belief Model constructs, and sexual behaviors. Input on intervention acceptability was obtained at 3 months.
RESULTS


Among 244 participants enrolled and randomized, the average age was 16 (±1.6), 80% were Hispanic/Latina, 53% had ever had vaginal sex, and 50% had used prescription birth control with 24% currently using a long-acting reversible method. Among those sexually active, 29% reported consistent condom use and 24% reported engaging in dual protection behaviors at last sex. Among participants with all follow-up data (N = 136), intervention participants had significant increases in sexual health knowledge and reported more prescription birth control use at follow-up than control participants. No significant outcome differences were found for condom use or dual protection behaviors. Intervention participants reported receiving messages, being introduced to new information, and reading and sharing the messages.
CONCLUSIONS


The pilot t4she sexual health intervention significantly improved knowledge and use of short-acting prescription birth control among young females in primary care and was acceptable by youth and feasible to implement.",2020,The pilot t4she sexual health intervention significantly improved knowledge and use of short-acting prescription birth control among young females in primary care and was acceptable by youth and feasible to implement.,"['support adolescent females', 'Participants were recruited from 2 federally qualified health centers', 'adolescent females', 'young females in primary care', 'Eligibility included: being 13-18 years of age; assigned female at birth; English-speaking; not currently pregnant and/or intending to become pregnant; and having texting capabilities', '244 participants enrolled and randomized, the average age was 16 (±1.6), 80% were Hispanic/Latina, 53% had ever had vaginal sex, and 50% had used prescription birth control with 24% currently using a long-acting reversible method']","['pilot texting intervention (""t4she', 'sexual health texting intervention']","['sexual health knowledge', 'prescription birth control use', 'dual protection behaviors', 'Acceptability and efficacy', 'knowledge, Health Belief Model constructs, and sexual behaviors', 'feasibility, acceptability and initial efficacy', 'condom use or dual protection behaviors']","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444864', 'cui_str': 'AM 13 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]","[{'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}]",244.0,0.0454064,The pilot t4she sexual health intervention significantly improved knowledge and use of short-acting prescription birth control among young females in primary care and was acceptable by youth and feasible to implement.,"[{'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Rinehart', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo; Department of Medicine, University of Colorado, School of Medicine (DJ Rinehart, EP Havranek, and M Cox-Martin), Aurora, Colo. Electronic address: deborah.rinehart@dhha.org.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Leslie', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo.'}, {'ForeName': 'M Joshua', 'Initials': 'MJ', 'LastName': 'Durfee', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Stowell', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cox-Martin', 'Affiliation': 'Department of Medicine, University of Colorado, School of Medicine (DJ Rinehart, EP Havranek, and M Cox-Martin), Aurora, Colo.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Thomas-Gale', 'Affiliation': 'Ambulatory Care Services, Denver Health and Hospital Authority (T Thomas-Gale), Denver, Colo.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Shlay', 'Affiliation': 'Denver Public Health, Denver Health and Hospital Authority (JC Shlay), Denver, Colo; Department of Family Medicine, School of Medicine, University of Colorado Anschutz Medical Campus (JC Shlay), Aurora, Colo.'}, {'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Havranek', 'Affiliation': 'Center for Health Systems Research, Office of Research, Denver Health and Hospital Authority (DJ Rinehart, S Leslie, MJ Durfee, M Stowell, and EP Havranek), Denver, Colo; Department of Medicine, University of Colorado, School of Medicine (DJ Rinehart, EP Havranek, and M Cox-Martin), Aurora, Colo.'}]",Academic pediatrics,['10.1016/j.acap.2019.09.004']
898,32419594,Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results.,"Purpose:  To present the 6-month results of the  S tromal Cell-Derived Factor-1 Plasmid  T reatment f o r  P atients with  P eripheral  A rtery  D isease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee.  Materials and Methods:  The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov  identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months.  Results:  Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major].  Conclusion:  Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.",2020,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","['109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or', '16-mg (n=36', 'Patients With Peripheral Artery Disease']","['Stromal Cell-Derived Factor-1 Plasmid Treatment', 'intramuscular injections of a non-viral DNA plasmid-based treatment vs placebo', 'S tromal Cell-Derived Factor-1 Plasmid  T reatment', 'biological agent vs placebo', 'placebo']","['toe-brachial index', '6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months', 'complete wound healing', 'rates of MALE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0012939', 'cui_str': 'Viral DNA'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C2116889', 'cui_str': 'Toe brachial index'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",109.0,0.510948,"In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups).","[{'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Hammad', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rundback', 'Affiliation': 'Interventional Institute, Holy Name Medical Center, Teaneck, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Bunte', 'Affiliation': ""Saint Luke's Mid America Heart Institute, St Luke's Hospital and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Miller', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Parag D', 'Initials': 'PD', 'LastName': 'Patel', 'Affiliation': 'BayCare Physician Partners, Clearwater, FL, USA.'}, {'ForeName': 'Saihari', 'Initials': 'S', 'LastName': 'Sadanandan', 'Affiliation': ""St Joseph's Hospital, Tampa, FL, USA.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fitzgerald', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pastore', 'Affiliation': 'Juventas Therapeutics, Cleveland, OH, USA.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kashyap', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Christ Hospital, Cincinnati, OH, USA.'}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center and Case Western Reserve University School of Medicine, Cleveland, OH, USA.'}]",Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists,['10.1177/1526602820919951']
899,32418680,The effect of nutritional education program on quality of life and serum electrolytes levels in hemodialysis patients: A single-blind randomized controlled trial.,"OBJECTIVE


To determine the effect of nutrition education program on hemodialysis patients' quality of life (QoL) and serum electrolytes levels.
METHODS


This study was a randomized controlled trial in which 94 eligible hemodialysis patients were randomly assigned to intervention (n = 48) and control (n = 46) groups. In the intervention group, the patients were trained in healthy nutrition for four weeks. After two months, samples of both groups completed the Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels were also measured and compared.
RESULTS


There were no significant differences in QoL scores and electrolytes between the two groups before intervention (p > 0.05). After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05). However, after intervention the levels of Na, K, P and Mg in the intervention group were significantly lower than in the control group (p < 0.05). Calcium level was not significantly different between the two groups after intervention (p = 0.16).
CONCLUSION


The results showed that e-learning is effective in improving the QoL and serum electrolytes of hemodialysis patients.
PRACTICE IMPLICATIONS


This paper could serve as support for clinical healthcare professionals to improve patient knowledge and QoL through virtual education methods.",2020,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"['94 eligible hemodialysis patients', 'hemodialysis patients']","['nutritional education program', 'nutrition education program']","['QoL scores and electrolytes', 'quality of life and serum electrolytes levels', 'levels of Na, K, P and Mg', ""hemodialysis patients' quality of life (QoL) and serum electrolytes levels"", 'Calcium level', 'QoL and serum electrolytes', 'Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels', 'QoL scores']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C1287347', 'cui_str': 'Serum electrolyte levels - finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}, {'cui': 'C0587355', 'cui_str': 'Electrolytes measurement, serum'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",94.0,0.0310619,After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05).,"[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Naseri-Salahshour', 'Affiliation': 'School of Nursing and Midwifery, Saveh University of Medical Sciences, Saveh, Iran. Electronic address: vahidnaseri1994@yahoo.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Sajadi', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Basij Sq., Sardasht Region, 6941738481 Arak, Iran. Electronic address: sajadimahbobeh@yahoo.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Nikbakht-Nasrabadi', 'Affiliation': 'School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: nikbakht@tums.ac.ir.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Davodabady', 'Affiliation': 'Clinical Research Development Center of Amiralmomenin Hospital, Arak University of Medical Sciences, Arak, Basij Sq., Sardasht Region, 6941738481 Iran. Electronic address: fahimedavodabady@gmail.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'College of Doctoral Studies, Grand Canyon University, Phoenix, AZ, USA. Electronic address: afournier2@my.gcu.edu.'}]",Patient education and counseling,['10.1016/j.pec.2020.03.021']
900,32418770,Comment on: Severe obesity and vitamin D deficiency treatment options before the bariatric surgery: a randomized clinical trial.,,2020,,[],[],[],[],[],[],,0.0865464,,"[{'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Furtado', 'Affiliation': 'Department of Bariatric Surgery, University of Maryland Medical Center, Baltimore, Maryland.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.004']
901,32418845,Association between Patient-Reported Outcomes and Time to Late Age-Related Macular Degeneration in the Laser Intervention in Early Stages of Age-Related Macular Degeneration Study.,"PURPOSE


To investigate the relationship between patient-reported outcome (PRO) questionnaire responses and time to late age-related macular degeneration (AMD; neovascular AMD [nAMD] or multimodal imaging [MMI]-defined atrophy) among individuals with bilateral large drusen, and the prognostic value of baseline PROs for 36-month AMD status.
DESIGN


Exploratory analyses from a multicenter randomized controlled trial of an AMD intervention (Australian New Zealand Clinical Trials Registry identifier, ACTRN12612000704897).
PARTICIPANTS


Sham treatment group of the Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n = 141; age, 50-88 years; 77% female).
METHODS


The 28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10) were administered at the baseline visit. The PRO scores were derived using rating scale models. Multivariate Cox regression adjusting for demographics and clinical measures of vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity) from the poorer-performing eye was used to investigate the association between PRO scores and time to late AMD in either eye. Multivariate competing-risk regression was used to estimate cause-specific subhazard ratios for nAMD and atrophy in either eye. Cross-validated logistic lasso models were used to estimate the predicted probability of AMD at 36 months. The area under the receiver operating characteristic curve was assessed to compare prognostic accuracy between models with and without PROs.
MAIN OUTCOME MEASURE


Time until nAMD or atrophy in either eye.
RESULTS


The PRO scores were skewed toward higher functional vision. Higher IVI-28 scores were associated with a lower risk of progression to MMI-defined atrophy (20 events: adjusted hazard ratio, 0.65/logit increase; P = 0.002) but not nAMD (10 events; P = 0.562). Insufficient evidence was found of an association between NVQ-10 score and rate of progression to late AMD (P ≥0.149). Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
CONCLUSIONS


On average, PROs were associated with an increased risk of progression from intermediate AMD to MMI-defined atrophy. Continuing development of instruments to record PROs in the early stages of AMD have the potential to produce inexpensive and efficient tools to assist in the assessment of disease severity and risk of AMD progression.",2020,"Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
","['individuals with bilateral large drusen', 'in Early Stages of Age-Related Macular Degeneration (LEAD) Study (n\xa0= 141; age, 50-88 years; 77% female']","['multimodal imaging [MMI]-defined atrophy', 'Laser Intervention', 'AMD intervention']","['NVQ-10 score and rate of progression to late AMD', 'PRO scores and time to late AMD', 'Higher IVI-28 scores', '28-item Impact of Vision Impairment (IVI-28) and 10-item Night Vision Questionnaire (NVQ-10', 'PRO scores', 'Time until nAMD or atrophy in either eye', 'Baseline IVI-28 scores', 'vision (low-luminance visual acuity, low-luminance deficit, and microperimetric sensitivity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0035312', 'cui_str': 'Retinal drusen'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1513743', 'cui_str': 'Imaging, Multimodal'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0010985', 'cui_str': 'Dark adaptation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0234684', 'cui_str': 'Luminance'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",141.0,0.0309192,"Baseline IVI-28 scores were found to contribute to the prognosis of atrophy at the 36-month visit (P = 0.010).
","[{'ForeName': 'Myra B', 'Initials': 'MB', 'LastName': 'McGuinness', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Centre for Biostatistics and Epidemiology, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: myra.mcguinness@unimelb.edu.au.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Finger', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Chi D', 'Initials': 'CD', 'LastName': 'Luu', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Fred K', 'Initials': 'FK', 'LastName': 'Chen', 'Affiliation': 'Centre for Ophthalmology and Visual Science (incorporating Lions Eye Institute), The University of Western Australia, Crawley, Australia, Department of Ophthalmology, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Jenifer J', 'Initials': 'JJ', 'LastName': 'Arnold', 'Affiliation': 'Marsden Eye Research, Sydney, Australia.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, United Kingdom.'}, {'ForeName': 'Robyn H', 'Initials': 'RH', 'LastName': 'Guymer', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye & Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2020.03.015']
902,32418846,Orally Administered Alpha Lipoic Acid as a Treatment for Geographic Atrophy: A Randomized Clinical Trial.,"PURPOSE


Alpha lipoic acid (ALA) is a nutraceutical and potent antioxidant that has shown efficacy in the retina light damage mouse model and in humans for multiple sclerosis. Our objective was to evaluate the efficacy and safety of oral ALA for the treatment of geographic atrophy (GA).
DESIGN


Randomized, controlled, double-masked, multicenter phase 2 clinical trial of ALA versus placebo.
PARTICIPANTS


Participants with unilateral or bilateral GA from age-related macular degeneration.
METHODS


Participants were randomized to 1200 mg daily of ALA or placebo. Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA) was obtained at baseline and every 6 months through month 18.
MAIN OUTCOME MEASURES


Annual rate of change over 18 months in square root-transformed area of GA in study eyes as measured on fundus autofluorescence. Secondary outcomes included the number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs.
RESULTS


Fifty-three participants (mean age, 80 years) were randomized (April 2016-August 2017). Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group. Unadjusted mean (standard error) annual change in GA area was 0.28 (0.02) mm and 0.31 (0.02) mm for the placebo and ALA groups, respectively (difference, 0.04 mm; 95% confidence interval [CI], -0.03 to 0.11 mm; P = 0.30). Adjusting for baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area was 0.27 (0.04) mm and 0.32 (0.05) mm for the placebo and ALA groups, respectively (difference, 0.05 mm; 95% CI, -0.02 to 0.12 mm; P = 0.14). At 18 months, the percent of eyes losing 15 letters or more of BCVA was 22% (8 of 36) and 14% (5 of 36) in the placebo and ALA groups, respectively (P = 0.54). No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
CONCLUSIONS


Results do not support ALA having beneficial effects on GA or BCVA. This trial design may be useful for other GA repurposing drug trials.",2020,"No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
","['Participants with unilateral or bilateral GA from age-related macular degeneration', 'Twenty-seven participants (37 eyes) were in the placebo group, and 26 participants (36 eyes) were in the ALA group', 'Fifty-three participants (mean age, 80 years', 'Participants', 'Geographic Atrophy']","['Alpha lipoic acid (ALA', 'ALA or placebo', 'oral ALA', 'Alpha Lipoic Acid', 'ALA versus placebo', 'placebo']","['number of adverse events (AEs), change in BCVA, and annual rate of change in area of GA measured on color photographs', 'Fundus autofluorescence, fundus color photography, and spectral-domain OCT were conducted and best-corrected visual acuity (BCVA', 'percent of eyes losing 15 letters or more of BCVA', 'efficacy and safety', 'Unadjusted mean (standard error) annual change in GA area', 'baseline GA area, number of GA lesions, and presence of subfoveal GA, the mean annual change in GA area']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C0016823', 'cui_str': 'Structure of fundus of eye'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}]",,0.764548,"No difference was found in the percentage of participants with nonserious AEs (P = 0.96) or serious AEs (P = 0.28) between the placebo and ALA groups.
","[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: Benjamin.Kim@uphs.upenn.edu.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hunter', 'Affiliation': 'Oregon Eye Consultants, Eugene, Oregon.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Brucker', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hahn', 'Affiliation': 'New Jersey Retina, Teaneck, New Jersey.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gehrs', 'Affiliation': 'Department of Ophthalmology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Retina Northwest, Portland, Oregon.'}, {'ForeName': 'Albert O', 'Initials': 'AO', 'LastName': 'Edwards', 'Affiliation': 'Oregon Retina, Eugene, Oregon.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California.'}, {'ForeName': 'Itzhak', 'Initials': 'I', 'LastName': 'Nissim', 'Affiliation': ""Division of Genetics and Metabolic Disease, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Pediatrics, Biochemistry and Biophysics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Grunwald', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Pistilli', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Dunaief', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.03.019']
903,32418881,Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation.,"INTRODUCTION


Pelvic floor muscle (PFM) training for postprostatectomy incontinence is considered a first line approach to rehabilitation, but PFM training for erectile dysfunction (ED) after surgery is less well known. With more than 1.4 million new cases diagnosed globally per year, there is a need for non-invasive options to assist sexual dysfunction recovery.
AIM


Commencing preoperatively and using both fast and slow twitch fibre training performed in standing postures, new protocols were developed to address clinical presentations with aims to reduce ED and impact on quality of life (QoL). Comparisons with ""usual care"" PFM training, prerehabilitation and postrehabilitation were then assessed.
METHODS


A randomised controlled trial of 97 men undergoing radical prostatectomy (RP) were allocated to either a control group (n = 47) performing ""usual care"" of 3 sets/d PFMT or an intervention group (n = 50), performing 6 sets/d in standing, commencing 5 weeks before RP.
OUTCOME MEASURES


Participants were assessed preoperatively and at 2, 6, and 12 weeks after RP using the Expanded Prostate Cancer Index Composite for Clinical Practice, International Index of Erectile Function-5, and real time ultrasound measurements of PFM function.
RESULTS


At all time points, there was a significant difference (P< 0.05) between groups; however, the only time point where this difference was clinically relevant was at 2 weeks after RP, with the intervention group reporting less distress in the Expanded Prostate Cancer Index Composite for Clinical Practice QoL outcome. Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
CONCLUSIONS


Early PFM training reduces early QoL impact for postprostatectomy ED, with faster return to continence enabling earlier commencement of penile rehabilitation. While our 12-week protocol and sample size was not powerful enough to demonstrate conclusive benefits of early PFM training for ED, PFM intervention after RP over longer times has been supported by others. Milios JE, Ackland TR, Green DJ. Pelvic Floor Muscle Training and Erectile Dysfunction in Radical Prostatectomy: A Randomized Controlled Trial Investigating a Non-Invasive Addition to Penile Rehabilitation. J Sex Med 2020;8:414-421.",2020,"Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
","['97 men undergoing', 'Radical Prostatectomy']","['Pelvic floor muscle (PFM) training', 'PFM training', 'radical prostatectomy (RP', 'Pelvic Floor Muscle Training', 'Penile Rehabilitation', 'control group (n\xa0= 47) performing ""usual care"" of 3 sets/d PFMT or an intervention group']","['EPIC-EF and real time ultrasound PFM function tests', 'bothersome scores', 'quality of life (QoL']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",97.0,0.077007,"Secondary measures of EPIC-EF and real time ultrasound PFM function tests demonstrated improvement over all time points in both groups with lower bothersome scores in the intervention group.
","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Milios', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia. Electronic address: jomilios22@gmail.com.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Ackland', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia.'}]",Sexual medicine,['10.1016/j.esxm.2020.03.005']
904,32421168,Effect of Patient Portal Reminders Sent by a Health Care System on Influenza Vaccination Rates: A Randomized Clinical Trial.,"Importance


Influenza vaccination rates across the US are low. Because few practices send patient reminders for influenza vaccination, a scalable patient reminder system is needed.
Objective


To evaluate the effect of patient reminders sent via a health care system's electronic health record patient portal on influenza vaccination rates.
Design, Setting, and Participants


This pragmatic, 4-arm randomized clinical trial was performed from October 1, 2018, to March 31, 2019, across the UCLA (University of California, Los Angeles) health care system. A total of 164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included.
Interventions


Patients due for an influenza vaccine were sent a letter via the patient portal of the health care system reminding them about the importance of influenza vaccination, safety of the vaccine, and morbidity associated with influenza. Patients were randomized within primary care practices to 1 of 4 study groups (no reminder [n = 41 070] vs 1 reminder [n = 41 055], 2 reminders [n = 41 046], or 3 reminders [n = 41 034]).
Main Outcomes and Measures


The primary outcome was receipt of 1 or more influenza vaccines as documented in the electronic health record, which was supplemented with influenza vaccination data from external sources (eg, pharmacies). Secondary outcomes were influenza vaccination rates among subgroups and influenza vaccinations self-reported by patients in reply to the portal-based query as having been received elsewhere.
Results


A total of 164 205 patients (mean [SD] age, 46.2 [19.6] years; 95 779 [58.3%] female) were randomly allocated to 1 of the 4 study arms. In the primary analysis across all ages and not including patient self-reported vaccinations in reply to portal reminders, influenza vaccination rates were 37.5% for those receiving no reminders, 38.0% for those receiving 1 reminder (P = .008 vs no reminder), 38.2% for those receiving 2 reminders (P = .03 vs no reminder), and 38.2% for those receiving 3 reminders (P = .02 vs no reminder). In the secondary analysis not including patient self-reported vaccinations, among adults aged 18 to 64 years (vaccination rates: 32.0% in the control group, 32.8% in the 1-reminder group, 32.8% in the 2-reminder group, and 32.8% in the 3-reminder group; P = .001), male patients (vaccination rates: 37.3% vs 38.3%, 38.6%, and 38.8%; P = .001), non-Hispanic patients (vaccination rates: 37.6% vs 38.2%, 38.3%, and 38.2%; P = .004), and those who were not vaccinated in the prior 2 years (vaccination rates: 15.3% vs 15.9%, 16.3%, and 16.1%; P < .001), vaccination rates were higher in the portal reminder groups than in the control group; the findings in these 3 subgroups mirrored the findings in the entire population. When self-reported vaccinations received elsewhere were included, influenza vaccination rates were 1.4 to 2.9 percentage points higher in the portal reminder groups, with a dose-response effect (0 reminders: 15 537 [37.8%]; 1 reminder: 16 097 [39.2%]; 2 reminders: 16 426 [40.0%]; and 3 reminders: 16 714 [40.7%]; P < .001).
Conclusions and Relevance


Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
Trial Registration


ClinicalTrials.gov Identifier: NCT03666026.",2020,"Conclusions and Relevance


Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
","['October 1, 2018, to March 31, 2019, across the UCLA (University of California, Los Angeles) health care system', 'A total of 164\u202f205 patients (mean [SD] age, 46.2 [19.6] years; 95 779 [58.3%] female', '164 205 patients in 52 primary care practices who had used the patient portal within 12 months were included']","['no reminder [n\u2009=\u200941 070] vs 1 reminder [n\u2009=\u200941 055], 2 reminders [n\u2009=\u200941 046], or 3 reminders [n\u2009=\u200941 034']","['Influenza Vaccination Rates', 'influenza vaccination data from external sources (eg, pharmacies', 'influenza vaccination rates', 'patient self-reported vaccinations in reply to portal reminders, influenza vaccination rates', 'vaccination rates', 'receipt of 1 or more influenza vaccines', 'influenza vaccination rates among subgroups and influenza vaccinations self-reported by patients in reply to the portal-based query as having been received elsewhere']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4277550', 'cui_str': 'Patient Portal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",164205.0,0.190866,"Conclusions and Relevance


Generic patient portal reminders were effective in minimally increasing influenza vaccination rates, but more intensive or more targeted patient motivational strategies appear to be needed.
","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Casillas', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}, {'ForeName': 'O Kenrik', 'Initials': 'OK', 'LastName': 'Duru', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Ong', 'Affiliation': 'Department of Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine Statistics Core, David Geffen School of Medicine, UCLA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, Missouri.""}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'Department of Information Services and Solutions, UCLA Health System, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sloyan', 'Affiliation': 'Department of Information Services and Solutions, UCLA Health System, Los Angeles, California.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Lerner', 'Affiliation': ""Department of Pediatrics, UCLA (University of California, Los Angeles) Mattel Children's Hospital, UCLA.""}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1602']
905,32421103,A Component Analysis of the Mindfulness-Based Positive Behavior Support (MBPBS) Program for Mindful Parenting by Mothers of Children with Autism Spectrum Disorder.,"Objectives


Mindfulness-Based Positive Behavior Support (MBPBS) has been shown to be effective in reducing stress and burnout in parents and professional caregivers of children and adolescents with intellectual and developmental disabilities (IDD) and autism spectrum disorder (ASD). The aim of this study was to assess the comparative effects of the mindfulness (MB) and positive behavior support (PBS) components against the MBPBS program for mindful parenting.
Methods


The study utilized a three-arm randomized controlled trial design, with a 10-week pre-treatment control condition, 30 weeks of intervention, and 3 years of post-intervention follow-up. Mothers of children with ASD were randomly assigned to the MB, PBS, and MBPBS conditions and provided 3 days of training specific to each condition. The effects of these programs were assessed on the mothers (i.e., training attendance, meditation time, perceived psychological stress) and spillover effects were assessed on their children with ASD (i.e., aggression, disruptive behavior, compliance with mothers' requests).
Results


Mothers in the MBPBS condition reported greater reductions in perceived psychological stress, followed by those in the MB condition, and with no significant changes reported by those in the PBS condition. Reduction in the children's aggression and disruptive behavior followed a similar pattern, with most to least significant reductions being in MBPBS, MB, and PBS condition, respectively. Significant increases in compliance (i.e., responsiveness to mothers' requests) were largest in the MBPBS condition, followed by MB, and then PBS. Changes across all variables for both mothers and their children were maintained for 3 years post-intervention. After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests.
Conclusions


Positive outcomes for mothers and their children with ASD were significantly greater in the MBPBS condition, followed by the MB condition, and least in the PBS condition. MBPBS appears to be an effective mindful parenting program on the assessed variables.",2020,"After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests.
","['Mindful Parenting by Mothers of Children with Autism Spectrum Disorder', 'parents and professional caregivers of children and adolescents with intellectual and developmental disabilities (IDD) and autism spectrum disorder (ASD', 'Mothers of children with ASD', 'mindful parenting', 'mothers and their children with ASD']","['Mindfulness-Based Positive Behavior Support (MBPBS) Program', 'MBPBS', 'mindfulness (MB) and positive behavior support (PBS) components against the MBPBS program', 'Mindfulness-Based Positive Behavior Support (MBPBS']","['MBPBS, MB, and PBS condition', ""children's aggression and disruptive behavior"", 'training attendance, meditation time, perceived psychological stress) and spillover effects', 'aggressive and disruptive behaviors', 'perceived psychological stress', ""compliance (i.e., responsiveness to mothers' requests"", ""children with ASD (i.e., aggression, disruptive behavior, compliance with mothers' requests""]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",,0.033065,"After time and training type were controlled for, meditation time was a significant predictor in reducing aggressive and disruptive behaviors, and in enhancing compliance of the children with mothers' requests.
","[{'ForeName': 'Nirbhay N', 'Initials': 'NN', 'LastName': 'Singh', 'Affiliation': '1Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA 30912 USA.'}, {'ForeName': 'Giulio E', 'Initials': 'GE', 'LastName': 'Lancioni', 'Affiliation': '2Department of Neuroscience and Sense Organs, University of Bari, Bari, Italy.'}, {'ForeName': 'Oleg N', 'Initials': 'ON', 'LastName': 'Medvedev', 'Affiliation': '3School of Psychology, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Yoon-Suk', 'Initials': 'YS', 'LastName': 'Hwang', 'Affiliation': '4Institute for Learning Sciences and Teacher Education, Australian Catholic University, Brisbane, Queensland Australia.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Myers', 'Affiliation': '5WellStar School of Nursing, Kennesaw State University, Kennesaw, GA USA.'}]",Mindfulness,['10.1007/s12671-020-01376-9']
906,26975187,Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.,"BACKGROUND


Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed.
METHODS


DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district. The study included a representative baseline cross-sectional survey, development of a structured intervention model, delivery of intervention for a minimum period of 18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques.
DISCUSSION


Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction.
TRIAL REGISTRATION


CTRI/2013/10/004049 . Registered 7 October 2013.",2016,"If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district.","['18 months by trained frontline health workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample', '10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters', 'small village with 250-300 households and well defined geographical boundaries', '12 clusters were randomly selected from a district', 'frontline community health workers for cardiovascular risk reduction']","[""task shifting' interventions""]",[],"[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0442825', 'cui_str': 'Well defined (qualifier value)'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",[],[],,0.112924,"If any of the intervention and control clusters were <10 km apart, one was dropped and replaced with another randomly selected cluster from the same district.","[{'ForeName': 'Panniyammakal', 'Initials': 'P', 'LastName': 'Jeemon', 'Affiliation': 'Centre for Control of Chronic Conditions, Public Health Foundation of India, New Delhi, India.'}, {'ForeName': 'Gitanjali', 'Initials': 'G', 'LastName': 'Narayanan', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Kashvi', 'Initials': 'K', 'LastName': 'Kahol', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Bharadwaj', 'Affiliation': 'Rajendra Prasad Government Medical College, Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Purty', 'Affiliation': 'Pondicherry Institute of Medical Sciences, Puducherry, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Negi', 'Affiliation': 'Indira Gandhi Medical College, Shimla, India.'}, {'ForeName': 'Sulaiman', 'Initials': 'S', 'LastName': 'Ladhani', 'Affiliation': 'Aga Khan Health Services, Mumbai, India.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Sanghvi', 'Affiliation': 'Sri Aurbindo Institute of Medical Sciences, Indore, India.'}, {'ForeName': 'Kuldeep', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Sri Aurbindo Institute of Medical Sciences, Indore, India.'}, {'ForeName': 'Deksha', 'Initials': 'D', 'LastName': 'Kapoor', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sobti', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Lall', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Sathyaprakash', 'Initials': 'S', 'LastName': 'Manimunda', 'Affiliation': 'Centre for Chronic Disease Control, Sector 44, Plot 47, Gurgaon, Haryana, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Gurudyal', 'Initials': 'G', 'LastName': 'Toteja', 'Affiliation': 'Indian Council of Medical Research, New Delhi, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Control of Chronic Conditions, Public Health Foundation of India, New Delhi, India. dprabhakaran@ccdcindia.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-016-2891-6']
907,32419304,"Efficacy and Safety of PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor, in Patients With Moderate-to-Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate.","OBJECTIVE


To evaluate the efficacy and safety of PF-06651600 (ritlecitinib), an irreversible inhibitor of JAK3 and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, in comparison with placebo in patients with rheumatoid arthritis (RA).
METHODS


An 8-week, phase II, double-blind, parallel-group study was conducted. Seventy patients who were seropositive for anti-citrullinated protein antibodies and/or rheumatoid factor were randomized 3:2 to receive oral PF-06651600 (200 mg once daily) or placebo for 8 weeks. Eligible patients had an inadequate response to methotrexate, and the study design allowed up to 50% of patients to have previously received 1 tumor necrosis factor inhibitor that was inadequately effective and/or not tolerated. The primary end point was change from baseline in the Simplified Disease Activity Index (SDAI) score at week 8, assessed by Bayesian analysis using an informative prior distribution for placebo response.
RESULTS


Mean change from baseline in the SDAI score at week 8 was greater in the PF-06651600 group (-26.1 [95% credible interval -29.7, -22.4]) than in the placebo group (-16.8 [95% credible interval -20.9, -12.7]; P < 0.001). Most adverse events (AEs) were mild in severity, and no treatment-related serious AEs, severe AEs, or deaths were reported. The most common classes of AE were infections and infestations as well as skin and subcutaneous tissue disorders; there was 1 mild case of herpes simplex in the PF-06651600 group that was considered to be treatment related, which resolved within 3 days without study treatment discontinuation or antiviral therapy.
CONCLUSION


Treatment with the oral JAK3/TEC inhibitor PF-06651600 (200 mg once daily) was associated with significant improvements in RA disease activity and was generally well-tolerated in this small 8-week study.",2020,"Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported.","['patients with rheumatoid arthritis (RA', 'Seventy patients, seropositive for anticitrullinated protein antibodies and/or rheumatoid factor', 'Patients with Moderate to Severe Rheumatoid Arthritis']","['oral PF-06651600 (200\xa0mg once daily [QD]) or placebo', 'oral JAK3/TEC inhibitor, PF-06651600', 'methotrexate', 'PF-06651600 (Ritlecitinib), a Novel JAK3/TEC Inhibitor', 'PF-06651600 (ritlecitinib', 'Methotrexate', 'placebo']","['infections and infestations and skin and subcutaneous tissue disorders', 'Mean change from baseline SDAI score', 'Simple Disease Activity Index (SDAI) score', 'RA disease activity', 'serious or severe AEs, or deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4505882', 'cui_str': 'PF-06651600'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178298', 'cui_str': 'Disorder of skin and/or subcutaneous tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.272349,"Most adverse events (AEs) were mild in severity, and no treatment-related serious or severe AEs, or deaths were reported.","[{'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Robinson', 'Affiliation': 'California Medical Research Associates, Northridge.'}, {'ForeName': 'Nemanja', 'Initials': 'N', 'LastName': 'Damjanov', 'Affiliation': 'University of Belgrade School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Bojana', 'Initials': 'B', 'LastName': 'Stamenkovic', 'Affiliation': 'Institute for Treatment and Rehabilitation Niska Banja and Nis University School of Medicine, Nis, Serbia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Radunovic', 'Affiliation': 'University of Belgrade School of Medicine, Belgrade, Serbia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Cox', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Zorayr', 'Initials': 'Z', 'LastName': 'Manukyan', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Banfield', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Chandra', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Vincent', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer, Inc., Groton, Connecticut.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Peeva', 'Affiliation': 'Pfizer, Inc., New York, New York.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Beebe', 'Affiliation': 'Pfizer, Inc., New York, New York.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41316']
908,32421159,Effect of Endovascular Treatment With Medical Management vs Standard Care on Severe Cerebral Venous Thrombosis: The TO-ACT Randomized Clinical Trial.,"Importance


To date, only uncontrolled studies have evaluated the efficacy and safety of endovascular treatment (EVT) in patients with cerebral venous thrombosis (CVT), leading to the lack of recommendations on EVT for CVT.
Objective


To evaluate the efficacy and safety of EVT in patients with a severe form of CVT.
Design, Setting, and Participants


TO-ACT (Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis) was a multicenter, open-label, blinded end point, randomized clinical trial conducted in 8 hospitals in 3 countries (the Netherlands, China, and Portugal). Patients were recruited from September 2011 to October 2016, and follow-up began in March 2012 and was completed in December 2017. Adult patients with radiologically confirmed CVT who had at least 1 risk factor for a poor outcome (mental status disorder, coma state, intracerebral hemorrhage, or thrombosis of the deep venous system) were included. Data were analyzed according to the intention-to-treat principle from March 2018 to February 2019. The trial was halted after the first interim analysis for reasons of futility.
Interventions


Patients were randomized to receive either EVT with standard medical care (intervention group) or guideline-based standard medical care only (control group). The EVT consisted of mechanical thrombectomy, local intrasinus application of alteplase or urokinase, or a combination of both strategies. Patients in the intervention group underwent EVT as soon as possible but no later than 24 hours after randomization.
Main Outcomes and Measures


Primary end point was the proportion of patients with a good outcome at 12 months (recovered without a disability; modified Rankin Scale [mRS] score of 0-1). Secondary end points were the proportion of patients with an mRS score of 0 to 1 at 6 months and an mRS score of 0 to 2 at 6 and 12 months, outcome on the mRS across the ordinal continuum at 12 months, recanalization rate, and surgical interventions in relation to CVT. Safety end points included symptomatic intracranial hemorrhage.
Results


Of the 67 patients enrolled and randomized, 33 (49%) were randomized to the intervention group and 34 (51%) were randomized to the control group. Patients in the intervention group vs those in the control group were slightly older (median [interquartile range (IQR)] age, 43 [33-50] years vs 38 [23-48] years) and comprised fewer women (23 women [70%] vs 27 women [79%]). The median (IQR) baseline National Institutes of Health Stroke Scale score was 12 (7-20) in the EVT group and 12 (5-20) in the standard care group. At the 12-month follow-up, 22 intervention patients (67%) had an mRS score of 0 to 1 compared with 23 control patients (68%) (relative risk ratio, 0.99; 95% CI, 0.71-1.38). Mortality was not statistically significantly higher in the EVT group (12% [n = 4] vs 3% [n = 1]; P = .20). The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1] vs 9% [n = 3]; P = .61).
Conclusions and Relevance


The TO-ACT trial showed that EVT with standard medical care did not appear to improve functional outcome of patients with CVT. Given the small sample size, the possibility exists that future studies will demonstrate better recovery rates after EVT for this patient population.
Trial Registration


ClinicalTrials.gov Identifier: NCT01204333.",2020,The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1],"['patients with a severe form of CVT', '8 hospitals in 3 countries (the Netherlands, China, and Portugal', 'Adult patients with radiologically confirmed CVT who had at least 1 risk factor for a poor outcome (mental status disorder, coma state, intracerebral hemorrhage, or thrombosis of the deep venous system) were included', 'Severe Cerebral Venous Thrombosis', 'patients with CVT', '67 patients enrolled and randomized, 33 (49%) were randomized to the intervention group and 34 (51', 'Patients were recruited from September 2011 to October 2016, and follow-up began in March 2012 and was completed in December 2017', 'patients with cerebral venous thrombosis (CVT']","['ACT (Thrombolysis or Anticoagulation', 'alteplase or urokinase', 'EVT with standard medical care (intervention group) or guideline-based standard medical care only (control group', 'EVT', 'endovascular treatment (EVT', 'Endovascular Treatment With Medical Management vs Standard Care']","['frequency of symptomatic intracerebral hemorrhage', 'functional outcome', 'proportion of patients with an mRS score of 0 to 1 at 6 months and an mRS score', 'recanalization rate, and surgical interventions in relation to CVT', 'efficacy and safety', 'symptomatic intracranial hemorrhage', 'mRS score', 'proportion of patients with a good outcome at 12 months (recovered without a disability; modified Rankin Scale [mRS] score of 0-1', 'median (IQR) baseline National Institutes of Health Stroke Scale score', 'Mortality', 'slightly older']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0947967', 'cui_str': 'Coma states'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1267406', 'cui_str': 'Venous system structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",67.0,0.10781,The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1],"[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Coutinho', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Susanna M', 'Initials': 'SM', 'LastName': 'Zuurbier', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Marie-Germaine', 'Initials': 'MG', 'LastName': 'Bousser', 'Affiliation': 'Department of Neurology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Xunming', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': 'Department of Interventional Radiology, XuanWu Hospital, Beijing, China.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Canhão', 'Affiliation': 'Serviço de Neurologia, Instituto de Medicina Molecular, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Department of Neurosciences and Mental Health, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Yvo B', 'Initials': 'YB', 'LastName': 'Roos', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Crassard', 'Affiliation': 'Department of Neurology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Ana Paiva', 'Initials': 'AP', 'LastName': 'Nunes', 'Affiliation': 'Department of Neurology, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Uyttenboogaart', 'Affiliation': 'Department of Neurology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Interventional Radiology, XuanWu Hospital, Beijing, China.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Emmer', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Roosendaal', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Houdart', 'Affiliation': 'Department of Neuroradiology, Hôpital Lariboisière, Paris, France.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Reekers', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'van den Berg', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'de Haan', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Majoie', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ferro', 'Affiliation': 'Serviço de Neurologia, Instituto de Medicina Molecular, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Department of Neurosciences and Mental Health, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stam', 'Affiliation': 'Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.1022']
909,26199949,First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).,"Background.  We report the first-in-human safety and immunogenicity evaluation of a highly attenuated, replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine. Methods.  Sixty healthy, HIV-1-uninfected adults were enrolled in a randomized, double-blinded, placebo-controlled dose-escalation study. Groups of 12 participants received rVSV HIV-1 gag vaccine at 5 dose levels (4.6 × 10(3) to 3.4 × 10(7) particle forming units) (N = 10/group) or placebo (N = 2/group), delivered intramuscularly as bilateral injections at 0 and 2 months. Safety monitoring included VSV cultures from blood, urine, saliva, and swabs of oral lesions. Vesicular stomatitis virus-neutralizing antibodies, T-cell immunogenicity, and HIV-1 specific binding antibodies were assessed. Results.  Local and systemic reactogenicity symptoms were mild to moderate and increased with dose. No severe reactogenicity or product-related serious adverse events were reported, and all rVSV cultures were negative. All vaccine recipients became seropositive for VSV after 2 vaccinations. gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost. Conclusions.  An attenuated replication-competent rVSV gag vaccine has an acceptable safety profile in healthy adults. This rVSV vector is a promising new vaccine platform for the development of vaccines to combat HIV-1 and other serious human diseases.",2015,gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost.,"['Sixty healthy, HIV-1-uninfected adults', 'healthy adults']","['replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine', 'rVSV HIV-1 gag vaccine', 'placebo', 'Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090']","['gag-specific T-cell responses', 'Local and systemic reactogenicity symptoms', 'VSV cultures from blood, urine, saliva, and swabs of oral lesions', 'severe reactogenicity or product-related serious adverse events']","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1623048', 'cui_str': 'Vesicular stomatitis virus (organism)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0328767', 'cui_str': 'Mycteroperca microlepis (organism)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0149744', 'cui_str': 'Oral lesion (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.274579,gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost.,"[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Fuchs', 'Affiliation': 'San Francisco Department of Public Health, California ; University of California , San Francisco.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'University of Pennsylvania , Philadelphia.'}, {'ForeName': 'Marnie L', 'Initials': 'ML', 'LastName': 'Elizaga', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': 'Division of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Frahm', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Kochar', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention , Fred Hutchinson Cancer Research Center , Seattle, Washington.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention , Fred Hutchinson Cancer Research Center , Seattle, Washington.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Edupuganti', 'Affiliation': 'Emory University , Atlanta, Georgia.'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Kalams', 'Affiliation': 'Vanderbilt University , Nashville, Tennessee.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke Human Vaccine Institute, Duke University Medical Center , Durham, North Carolina.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sheets', 'Affiliation': 'Division of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pensiero', 'Affiliation': 'Division of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Tremblay', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'Terry J', 'Initials': 'TJ', 'LastName': 'Higgins', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Latham', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Egan', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Clarke', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Eldridge', 'Affiliation': 'Profectus Biosciences, Inc. , Tarrytown, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mulligan', 'Affiliation': ''}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': ''}, {'ForeName': 'Scharla', 'Initials': 'S', 'LastName': 'Estep', 'Affiliation': ''}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Rybczyk', 'Affiliation': ''}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Dunbar', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Buchbinder', 'Affiliation': ''}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Reese', 'Initials': 'R', 'LastName': 'Isbell', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Chinnell', 'Affiliation': ''}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Escamilla', 'Affiliation': ''}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tseng', 'Affiliation': ''}, {'ForeName': 'Ramey', 'Initials': 'R', 'LastName': 'Fair', 'Affiliation': ''}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Ramirez', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Broder', 'Affiliation': ''}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Briesemeister', 'Affiliation': ''}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': ''}]",Open forum infectious diseases,['10.1093/ofid/ofv082']
910,26173719,Barriers to uptake among high-risk individuals declining participation in lung cancer screening: a mixed methods analysis of the UK Lung Cancer Screening (UKLS) trial.,"OBJECTIVE


The current study aimed to identify the barriers to participation among high-risk individuals in the UK Lung Cancer Screening (UKLS) pilot trial.
SETTING


The UKLS pilot trial is a randomised controlled trial of low-dose CT (LDCT) screening that has recruited high-risk people using a population approach in the Cambridge and Liverpool areas.
PARTICIPANTS


High-risk individuals aged 50-75 years were invited to participate in UKLS. Individuals were excluded if a LDCT scan was performed within the last year, if they were unable to provide consent, or if LDCT screening was unable to be carried out due to coexisting comorbidities.
OUTCOME MEASURES


Statistical associations between individual characteristics and UKLS uptake were examined using multivariable regression modelling. In those who completed a non-participation questionnaire (NPQ), thematic analysis of free-text data was undertaken to identify reasons for not taking part, with subsequent exploratory linkage of key themes to risk factors for non-uptake.
RESULTS


Comparative data were available from 4061 high-risk individuals who consented to participate in the trial and 2756 who declined participation. Of those declining participation, 748 (27.1%) completed a NPQ. Factors associated with non-uptake included: female gender (OR=0.64, p<0.001), older age (OR=0.73, p<0.001), current smoking (OR=0.70, p<0.001), lower socioeconomic group (OR=0.56, p<0.001) and higher affective risk perception (OR=0.52, p<0.001). Among non-participants who provided a reason, two main themes emerged reflecting practical and emotional barriers. Smokers were more likely to report emotional barriers to participation.
CONCLUSIONS


A profile of risk factors for non-participation in lung screening has emerged, with underlying reasons largely relating to practical and emotional barriers. Strategies for engaging high-risk, hard-to-reach groups are critical for the equitable uptake of a potential future lung cancer screening programme.
TRIAL REGISTRATION NUMBER


The UKLS trial was registered with the International Standard Randomised Controlled Trial Register under the reference 78513845.",2015,"Factors associated with non-uptake included: female gender (OR=0.64, p<0.001), older age (OR=0.73, p<0.001), current smoking (OR=0.70, p<0.001), lower socioeconomic group (OR=0.56, p<0.001) and higher affective risk perception (OR=0.52, p<0.001).","['High-risk individuals aged 50-75\u2005years were invited to participate in UKLS', '4061 high-risk individuals who consented to participate in the trial and 2756 who declined participation', 'high-risk individuals in the UK Lung Cancer Screening (UKLS) pilot trial', 'recruited high-risk people using a population approach in the Cambridge and Liverpool areas']",['low-dose CT (LDCT'],['affective risk perception'],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.101935,"Factors associated with non-uptake included: female gender (OR=0.64, p<0.001), older age (OR=0.73, p<0.001), current smoking (OR=0.70, p<0.001), lower socioeconomic group (OR=0.56, p<0.001) and higher affective risk perception (OR=0.52, p<0.001).","[{'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Cochrane Institute of Primary Care and Public Health, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Kate J', 'Initials': 'KJ', 'LastName': 'Lifford', 'Affiliation': 'Cochrane Institute of Primary Care and Public Health, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': 'Cochrane Institute of Primary Care and Public Health, Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McRonald', 'Affiliation': 'Cochrane Institute of Primary Care and Public Health, Cardiff University School of Medicine, Cardiff, UK Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, The University of Liverpool Cancer Research Centre, Liverpool, UK.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Yadegarfar', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, The University of Liverpool Cancer Research Centre, Liverpool, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Centre, Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Centre for Population Health Sciences, Medical School, Edinburgh, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Hansell', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital, London UK.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Field', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, Institute of Translational Medicine, The University of Liverpool Cancer Research Centre, Liverpool, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Cochrane Institute of Primary Care and Public Health, Cardiff University School of Medicine, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2015-008254']
911,31141465,Benefits of Yoga on IL-6: Findings from a Randomized Controlled Trial of Yoga for Depression.,"The present research sought to examine whether hatha yoga, implemented as an adjunctive intervention for major depression, influences markers of inflammation. A subset of 84 participants who were enrolled in a randomized controlled trial (RCT) of hatha yoga vs. health education control provided blood samples at baseline (pre-treatment) and at 3-(during treatment) and 10-week (end of treatment) follow-up visits. To be eligible for the RCT, participants met criteria for a current or recent (past two years) major depressive episode, had current elevated depression symptoms, and current antidepressant medication use. Venous blood was drawn between 2 and 6 pm and following at least one hour of fasting, and inflammatory markers (IL-6, CRP, and TNF-α) were assayed. Effects of participation in yoga relative to health education on inflammatory markers over time were examined with latent growth analyses. We observed a significant reduction in IL-6 concentrations in the yoga treatment group relative to the health education control group as demonstrated by a negative interaction between treatment group and slope of IL-6. TNF-α and CRP did not evidence significant interactions of treatment group by mean slope or intercept. In addition to the benefits of hatha yoga as an adjunctive intervention for individuals who have shown inadequate response to antidepressant medications, our findings point to possible benefits of yoga on IL-6 in depressed populations. Further research is needed to explore the effects of hatha yoga on immune function over time.",2019,We observed a significant reduction in IL-6 concentrations in the yoga treatment group relative to the health education control group as demonstrated by a negative interaction between treatment group and slope of IL-6.,"['84 participants who were enrolled in a randomized controlled trial (RCT) of', 'participants met criteria for a current or recent (past two years) major depressive episode, had current elevated depression symptoms, and current antidepressant medication use']","['TNF-α and CRP', 'hatha yoga vs. health education control', 'hatha yoga']","['Venous blood', 'IL-6 concentrations', 'inflammatory markers (IL-6, CRP, and TNF-α']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",,0.0655882,We observed a significant reduction in IL-6 concentrations in the yoga treatment group relative to the health education control group as demonstrated by a negative interaction between treatment group and slope of IL-6.,"[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Nugent', 'Affiliation': ""a Bradley Hasbro Children's Research Center , Rhode Island Hospital , Providence , RI , USA.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Brick', 'Affiliation': ""a Bradley Hasbro Children's Research Center , Rhode Island Hospital , Providence , RI , USA.""}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Armey', 'Affiliation': 'c Department of Psychiatry and Human Behavior , Alpert Medical School at Brown University , Providence , RI , USA.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Tyrka', 'Affiliation': 'c Department of Psychiatry and Human Behavior , Alpert Medical School at Brown University , Providence , RI , USA.'}, {'ForeName': 'Kathryn K', 'Initials': 'KK', 'LastName': 'Ridout', 'Affiliation': 'c Department of Psychiatry and Human Behavior , Alpert Medical School at Brown University , Providence , RI , USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'c Department of Psychiatry and Human Behavior , Alpert Medical School at Brown University , Providence , RI , USA.'}]","Behavioral medicine (Washington, D.C.)",['10.1080/08964289.2019.1604489']
912,31804698,The Effect of Botulinum Toxin Injection into the Common Extensor Tendon in Patients with Chronic Lateral Epicondylitis: A Randomized Trial.,"BACKGROUND


Botulinum toxin (BTX) is widely used for pain control in various musculoskeletal disorders.
OBJECTIVES


We evaluated the analgesic effect of botulinum toxin type A (BTX-A) in chronic lateral epicondylitis and compared the effect between 10 and 50 IU of BTX-A.
METHODS


Sixty subjects with chronic lateral epicondylitis were included and underwent a BTX-A injection in the common extensor tendon. The subjects were randomly allocated into two groups: the small-dose group (SD group; 30 subjects, 10 IU) and large-dose group (LD group; 30 subjects, 50 IU). Treatment outcomes were evaluated by measuring the pain level using the numeric rating scale (NRS) and measuring grip strength before and one, two, three, four, five, and six months after treatment.
RESULTS


Subjects in both groups showed a significant decrease in NRS scores at all evaluation time points after treatment. The reduction in NRS scores was significantly greater in the LD group at one, two, three, and four months after treatment. Six months after treatment, 19 subjects (63.3%) in the SD group and 21 (70%) in the LD group reported successful pain relief (pain relief ≥50%). The rate of successful pain relief was not significantly different between the two groups. Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment.
CONCLUSIONS


BTX-A injection into the common extensor tendon can be a good treatment option for chronic lateral epicondylitis. The 50-IU BTX-A injection achieved a better outcome than the 10-IU injection.",2020,"Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment.
","['chronic lateral epicondylitis', 'Sixty subjects with chronic lateral epicondylitis', 'Patients with Chronic Lateral Epicondylitis']","['BTX-A injection', 'Botulinum Toxin Injection', 'Botulinum toxin (BTX', 'botulinum toxin type A (BTX-A']","['pain level using the numeric rating scale (NRS) and measuring grip strength', 'successful pain relief', 'Grip strength', 'rate of successful pain relief', '50-IU BTX', 'NRS scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",60.0,0.0659534,"Grip strength was more increased in the LD group at one, two, three, four, and six months after treatment.
","[{'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Madi Pain Management Center, Jeonju, Republic of Korea.'}, {'ForeName': 'Hyun Hee', 'Initials': 'HH', 'LastName': 'Choi', 'Affiliation': 'Madi Research and Development Center, Jeonju, Republic of Korea.'}, {'ForeName': 'Min Cheol', 'Initials': 'MC', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, College of Medicine, Yeungnam University, Daegu, Republic of Korea.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz323']
913,32418143,"Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Acetylsalicylic Acid in Fixed-Dose Combination with Clopidogrel Versus Enteric Aspirin in Chinese Subjects Under Fasting Conditions: A Phase 1, Open-Label, Randomized, Crossover Study.","INTRODUCTION


Dual antiplatelet therapy, aspirin and a P2Y 12  inhibitor, is recommended to prevent thrombotic complications of acute coronary syndrome. Clopidogrel plus acetylsalicylic acid combination is the most commonly used dual antiplatelet therapy recommended by international guidelines and in Chinese clinical practice. Poor adherence to dual antiplatelet therapy or premature interruption of dual antiplatelet therapy is an important contributor to cardiovascular mortality and lethal cardiovascular events. Clopidogrel + acetylsalicylic acid fixed-dose combination enhances adherence to dual antiplatelet therapy. Herein, we aimed to evaluate bioequivalence of acetylsalicylic acid and clopidogrel in fixed-dose combination compared with simultaneous administration of their individual formulations in healthy Chinese subjects under fasting conditions.
METHODS


This was a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study with a washout period of 10 days conducted in healthy Chinese volunteers. Subjects were randomized to receive Co-Plavix ®  (test formulation- fixed-dose combination of 100 mg acetylsalicylic acid and 75 mg clopidogrel) once and reference formulations (coadministration of individual formulations of 100 mg acetylsalicylic acid and 75 mg clopidogrel) twice during the study period. Pharmacokinetic parameters were analyzed for acetylsalicylic acid, its metabolite salicylic acid, clopidogrel, and its metabolite SR26334. As acetylsalicylic acid shows high intrasubject variability, the reference-scaled average bioequivalence (RSABE) approach was implemented for acetylsalicylic acid analysis, while bioequivalence of clopidogrel was assessed using the average bioequivalence method. Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel were calculated.
RESULTS


In total, 171 healthy subjects were enrolled in this study. Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study. Regarding acetylsalicylic acid exposure, as reference within-subject standard deviation (SD W ) was at least 0.294 for acetylsalicylic acid C max , AUC last , and AUC, the RSABE analysis method was used to assess bioequivalence for all three parameters. The point estimates were within the 0.80-1.25 range (1.19, 1.09, and 1.04, respectively), and upper one-sided 95% CIs of scaled average bioequivalence metric were at most 0 (- 0.30, - 0.14, and - 0.10, respectively). Thus, bioequivalence was demonstrated with acetylsalicylic acid. Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
CONCLUSION


Application of the reference-scaled average bioequivalence approach to evaluate bioequivalence of acetylsalicylic acid in Chinese male and female healthy volunteers under fasting conditions demonstrated bioequivalence of test and reference formulations.
TRIAL REGISTRATION


CTR20181695.",2020,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","['171 healthy subjects', 'Subjects were randomized and 170 subjects were treated with test or reference formulation; 164 subjects completed the study', 'healthy Chinese subjects under fasting conditions', 'Chinese Subjects Under Fasting Conditions', 'healthy Chinese volunteers', 'Chinese male and female healthy volunteers']","['Clopidogrel plus acetylsalicylic acid combination', 'acetylsalicylic acid and 75\xa0mg clopidogrel', 'acetylsalicylic acid', 'acetylsalicylic acid and clopidogrel', 'aspirin', 'Clopidogrel Versus Enteric Aspirin', 'Co-Plavix ®  (test formulation- fixed-dose combination of 100\xa0mg acetylsalicylic acid and 75\xa0mg clopidogrel', 'Clopidogrel\u2009+\u2009acetylsalicylic acid']","['Point ratios and confidence intervals (CIs) for AUC, AUC last , and C max  for acetylsalicylic acid and clopidogrel', 'geometric mean ratios of clopidogrel C max , AUC last , and AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0633084', 'cui_str': 'Plavix'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",171.0,0.0504812,"Bioequivalence was also achieved with clopidogrel as the 90% CIs for geometric mean ratios of clopidogrel C max , AUC last , and AUC were within the bioequivalence range (0.80-1.25).
","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Di', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Phase I Center, Luzhong Hospital, Shandong, China. jie.hou@estartpoc.com.'}]",Advances in therapy,['10.1007/s12325-020-01369-z']
914,30928252,Corneal crosslinking and intracorneal ring segments for keratoconus: A randomized study of concurrent versus sequential surgery.,"PURPOSE


To assess outcomes of corneal crosslinking (CXL) and intracorneal ring segments (ICRS) (Intacs) used adjunctively, and then compare the safety and efficacy of concurrent versus sequential surgery.
SETTING


Cornea and refractive surgery subspecialty practice.
DESIGN


Prospective randomized clinical trial.
METHODS


Patients were randomized to one of two groups: ICRS first, immediately followed by CXL during the same session (n = 104), or ICRS followed by CXL 3 months later (n = 94). Outcomes included changes in maximum keratometry (K) and topographic inferior-superior (I-S) difference, maximum flattening of topographic K, and changes in uncorrected (UDVA) and corrected (CDVA) distance visual acuities. These were analyzed in the entire cohort, in the two randomized groups, and in subgroups stratified to ICRS size and placement. Patients were followed for 6 months.
RESULTS


The study comprised 198 eyes of 198 patients. Overall, maximum K decreased by an average of 2.5 D, I-S difference improved by 3.9 D, and there was an average maximum flattening of -7.5 D. The UDVA improved by 2.0 logarithm of the minimum angle of resolution lines, on average, and the CDVA improved by 1.1 lines. There was no significant difference between the sequential and concurrent groups in any of the outcomes analyzed. There were 6 clinically significant adverse events.
CONCLUSIONS


CXL and ICRS can be used adjunctively with substantial improvement in corneal topography, and with no increase in safety concerns over each procedure alone. Sequential and concurrent treatment with ICRS and CXL show equivalent outcomes. Both thicker segment size and single segment placement seem to result in greater topographic improvement.",2019,"Overall, maximum K decreased by an average of 2.5 D, I-S difference improved by 3.9 D, and there was an average maximum flattening of -7.5 D.","['Patients', 'Cornea and refractive surgery subspecialty practice', '198 eyes of 198 patients']","['Corneal crosslinking and intracorneal ring segments', 'ICRS and CXL', 'corneal crosslinking (CXL) and intracorneal ring segments (ICRS) (Intacs', 'sequential surgery', 'ICRS followed by CXL', 'CXL and ICRS']","['safety and efficacy', 'maximum K', 'changes in maximum keratometry (K) and topographic inferior-superior (I-S) difference, maximum flattening of topographic K, and changes in uncorrected (UDVA) and corrected (CDVA) distance visual acuities', 'safety concerns', 'UDVA', 'CDVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C1706535', 'cui_str': 'Refractive surgery specialty'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C3879219', 'cui_str': 'Intracorneal ring segment (physical object)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430885', 'cui_str': 'Keratometry (procedure)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}]",198.0,0.0776748,"Overall, maximum K decreased by an average of 2.5 D, I-S difference improved by 3.9 D, and there was an average maximum flattening of -7.5 D.","[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hersh', 'Affiliation': 'Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, New Jersey, USA; Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA. Electronic address: phersh@vision-institute.com.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Issa', 'Affiliation': 'Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, New Jersey, USA; Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Greenstein', 'Affiliation': 'Cornea and Laser Eye Institute-Hersh Vision Group, CLEI Center for Keratoconus, Teaneck, New Jersey, USA; Department of Ophthalmology, Rutgers-New Jersey Medical School, Newark, New Jersey, USA.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2019.01.020']
915,32417961,Postoperative morbidity after adenotonsillectomy versus adenopharyngoplasty in young children with obstructive sleep apnea: an RCT.,"PURPOSE


In our previous randomized controlled trial (RCT), comparing adenotonsillectomy (ATE) with adenopharyngoplasty (APP) in children with severe obstructive sleep apnea (OSA), there were no differences in respiratory sleep parameters or quality of life. The purpose of the present report was to evaluate postoperative morbidity from this RCT.
METHODS


The study was a blinded RCT in 83 children (ATE = 47; APP = 36), 2-4 years of age, with an obstructive apnea-hypopnea index of ≥ 10. Pain was assessed from the first until the tenth day after surgery with a logbook that reported pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change. Bleeding, infection, satisfaction with treatment, speech, and swallowing were assessed with a questionnaire and medical records 6 months after surgery.
RESULTS


Sixty-four children (77%) returned the logbook and 65 (78%) answered the questionnaire. The median (interquartile range) day the children graded themselves as pain free (FPS-R = 0) was 7 (6-10) after ATE, compared with 9 (7 to > 10) after APP (p = 0.018). There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
CONCLUSION


The results regarding postoperative morbidity were in favor of ATE and the results from our previous report showed no advantages of APP. Therefore, APP should not be recommended in young, otherwise healthy children with OSA.",2020,"There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
","['83 children (ATE\u2009=\u200947; APP\u2009=\u200936), 2-4\xa0years of age, with an obstructive apnea-hypopnea index of\u2009≥\u200910', 'healthy children with OSA', 'young children with obstructive sleep apnea', 'children with severe obstructive sleep apnea (OSA']","['adenotonsillectomy versus adenopharyngoplasty', 'adenotonsillectomy (ATE) with adenopharyngoplasty (APP']","['respiratory sleep parameters or quality of life', 'Pain', 'pain free', 'postoperative morbidity', 'pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech', 'Postoperative morbidity', 'impaired speech after APP', 'pain by child (FPS-R, Faces Pain Scale-Revised) and caregiver (visual analogue scale), analgesic use, return to normal diet, and weight change', 'Bleeding, infection, satisfaction with treatment, speech, and swallowing']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0233715', 'cui_str': 'Disturbance in speech'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2676780', 'cui_str': 'Progeroid Syndrome, Congenital, Petty Type'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.0413008,"There were no other significant differences between the groups regarding any other pain-related outcomes, bleeding, infection, satisfaction, swallowing, or speech, but three children (11%) reported impaired speech after APP compared to none after ATE (p = 0.067).
","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fehrm', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden. johan.fehrm@sll.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borgström', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nerfeldt', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06035-2']
916,31030773,Comparative evaluation of femtosecond laser-assisted cataract surgery and conventional phacoemulsification in eyes with a shallow anterior chamber.,"PURPOSE


To compare intraoperative performance and postoperative outcomes between femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification in eyes with a shallow anterior chamber (AC).
SETTING


Iladevi Cataract & IOL Research Centre, India.
DESIGN


Prospective randomized masked clinical study.
METHODS


Patients undergoing cataract surgery with a shallow AC (<2.5 mm) were randomized to have FLACS (Group 1, n = 91) or conventional phacoemulsification (Group 2, n = 91). Patients were followed up at 1 day, 1 week, and at 1, 3, and 6 months. The primary outcome measure was central corneal thickness (CCT). The secondary outcome measures were corneal clarity, AC cells and flare, endothelial cell density (ECD), coefficient of variance, hexagonality, and uncorrected distance visual acuity (UDVA) at 1 week.
RESULTS


The study comprised 182 eyes (91 in each group) The cumulative dissipative energy was lower in the FLACS group (P < .05). The mean CCT was significantly lower with FLACS (540.40 μm + 49.40 [SD] vs 556 + 12.5 μm, P = .03) at 1 day and 1 week (535.5 + 44.3 μm vs 551 + 40.8 μm, P = .04), with fewer eyes having higher than grade 2 AC cells and flare with FLACS (85% vs 72%, P = .056) at 1 day and 1 week (15% vs 28%, P = .03). At 1 week, the UDVA was better with FLACS (0.089 ± 0.31 logarithm of the minimum angle of resolution [logMAR] vs 0.178 ± 0.65 logMAR, P = .042). At 6 months, the reduction in ECD was lower in the FLACS group; however, the difference was not statistically significant.
CONCLUSION


In eyes with shallow ACs, compared with conventional phacoemulsification, FLACS maintained clearer corneas, showed less increase in CCT, lower AC inflammation, and better UDVA in the early postoperative period.",2019,The cumulative dissipative energy was lower in the FLACS group (P < .05).,"['eyes with a shallow anterior chamber (AC', '182 eyes (91 in each group', 'eyes with a shallow anterior chamber', 'Patients undergoing cataract surgery with a shallow AC (<2.5\xa0mm']","['femtosecond laser-assisted cataract surgery and conventional phacoemulsification', 'femtosecond laser-assisted cataract surgery (FLACS', 'conventional phacoemulsification', 'conventional phacoemulsification, FLACS', 'FLACS']","['mean CCT', 'central corneal thickness (CCT', 'CCT, lower AC inflammation, and better UDVA', 'corneal clarity, AC cells and flare, endothelial cell density (ECD), coefficient of variance, hexagonality, and uncorrected distance visual acuity (UDVA', 'grade 2 AC cells and flare with FLACS', 'intraoperative performance and postoperative outcomes', 'cumulative dissipative energy', 'reduction in ECD']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0423276', 'cui_str': 'Shallow anterior chamber of eye (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property) (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell count'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0722478,The cumulative dissipative energy was lower in the FLACS group (P < .05).,"[{'ForeName': 'Viraj A', 'Initials': 'VA', 'LastName': 'Vasavada', 'Affiliation': 'Iladevi Cataract & IOL Research Centre, Ahmedabad, India. Electronic address: viraj@raghudeepeyeclinic.com.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Iladevi Cataract & IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Abhay R', 'Initials': 'AR', 'LastName': 'Vasavada', 'Affiliation': 'Iladevi Cataract & IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Iladevi Cataract & IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Iladevi Cataract & IOL Research Centre, Ahmedabad, India.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.11.037']
917,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND


Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.
METHODS


Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).
RESULTS


188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.
CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021']
918,24562789,The minimum important difference for the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire.,"INTRODUCTION AND HYPOTHESIS


Although the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ) is widely used to assess sexual function in women, the minimum important difference (MID) (defined as the smallest difference in scores of a patient-reported outcome measure that is perceived by patients as beneficial or harmful and which would lead the clinician to consider a change in treatment) is not known. The objective was to estimate the MID for the PISQ.
METHODS


Two study populations, one of women with overactive bladder (OAB) and urgency UI (UUI) treated with tolterodine in a placebo-controlled trial (cohort I), and one of women treated surgically for prolapse and/or UI (cohort II) were used. Cohort I anchors were the Overactive Bladder Questionnaire (OAB-q), the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Treatment Benefit Questionnaire (PPTBQ), and the change in number of UUI episodes in bladder diaries. Distribution MIDs were also calculated.
RESULTS


In the anchor-based analysis, the MID values for changes in PISQ total scores at 3 months in cohort I were 5 points using the UUI anchor (diary-dry women), 5 points using the PPBC anchor, 5 points with the PPTBQ, and 9 points with the OAB-q. In cohort II, the MID at week 12 in PISQ total scores was 7 points in women with improved IIQ-7 scores. The distribution-based MID in PISQ total scores was 5.3 points in cohort I and 5.8 points in cohort II.
CONCLUSION


A reasonable estimate of MID for the PISQ total score is 6 points. Improvements that meet these thresholds may be considered clinically important.",2014,"In cohort II, the MID at week 12 in PISQ total scores was 7 points in women with improved IIQ-7 scores.","['Two study populations, one of women with overactive bladder (OAB) and urgency UI (UUI) treated with tolterodine in a placebo-controlled trial (cohort I), and one of women treated surgically for prolapse and/or UI (cohort II) were used']",[],"['IIQ-7 scores', 'PISQ total scores', 'Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ', 'Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire', 'Distribution MIDs', 'Overactive Bladder Questionnaire (OAB-q), the Patient Perception of Bladder Condition (PPBC), the Patient Perception of Treatment Benefit Questionnaire (PPTBQ', 'distribution-based MID in PISQ total scores']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.0666649,"In cohort II, the MID at week 12 in PISQ total scores was 7 points in women with improved IIQ-7 scores.","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Mamik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1176 5th Avenue, Klingenstein Pavilion, 9th Floor, Box 1170, New York, NY, 10029, USA, mamta.mamik@gmail.com.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Qualls', 'Affiliation': ''}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Morrow', 'Affiliation': ''}]",International urogynecology journal,['10.1007/s00192-014-2342-9']
919,24767729,"Changes in fruit and vegetable consumption of third-grade students in body quest: food of the warrior, a 17-class childhood obesity prevention program.","OBJECTIVE


To increase fruit and vegetable (FV) consumption of youth in Body Quest: Food of the Warrior (BQ), a childhood obesity prevention program.
DESIGN


Quasi-experimental.
SETTING


Supplemental Nutrition Assistance Program-Education eligible schools (n = 60).
PARTICIPANTS


Third-grade students (n = 2,477).
INTERVENTION


Treatment groups (n = 1,674) self-reported foods consumed through the School Lunch Program for 17 weekly assessments; they participated in BQ curriculum, iPad app education, and weekly FV tastings. Control groups (n = 803) completed only pre- and post-assessments.
MAIN OUTCOME MEASURE


Weekly FV consumed through School Lunch Program.
ANALYSIS


ANCOVA and growth modeling.
RESULTS


From before to after the program, the treatment group demonstrated significant, moderate increases in fruit (P < .01) and vegetable (P < .001) consumptions, increasing from 7 to 8 weekly FV servings. After the program, the treatment group consumed significantly (P < .001) more FV than the control group. Fruit and vegetable consumption increased to class 10 and then stabilized. From before to after the program, all FV predictors were significantly higher and included gender (vegetables), race (FV), and free/reduced lunch (fruit).
CONCLUSIONS AND IMPLICATIONS


Nutrition programs can increase FV intake. Even moderate increases in FV intake can be an initial step for the prevention of chronic disease.",2014,"From before to after the program, the treatment group demonstrated significant, moderate increases in fruit (P < .01) and vegetable (P < .001) consumptions, increasing from 7 to 8 weekly FV servings.","['third-grade students in body quest', 'Third-grade students (n = 2,477', 'Supplemental Nutrition Assistance Program-Education eligible schools (n = 60']","['self-reported foods consumed through the School Lunch Program for 17 weekly assessments; they participated in BQ curriculum, iPad app education, and weekly FV tastings']","['FV intake', 'fruit and vegetable (FV) consumption', 'moderate increases in fruit', 'Fruit and vegetable consumption', 'gender (vegetables), race (FV), and free/reduced lunch (fruit']","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}]",2477.0,0.0141936,"From before to after the program, the treatment group demonstrated significant, moderate increases in fruit (P < .01) and vegetable (P < .001) consumptions, increasing from 7 to 8 weekly FV servings.","[{'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Struempler', 'Affiliation': 'Expanded Food and Nutrition Education Program and Supplemental Nutrition Assistance Program-Education, Auburn University, Auburn, AL. Electronic address: struebj@auburn.edu.'}, {'ForeName': 'Sondra M', 'Initials': 'SM', 'LastName': 'Parmer', 'Affiliation': 'Expanded Food and Nutrition Education Program and Supplemental Nutrition Assistance Program-Education, Auburn University, Auburn, AL.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Mastropietro', 'Affiliation': 'Expanded Food and Nutrition Education Program and Supplemental Nutrition Assistance Program-Education, Auburn University, Auburn, AL.'}, {'ForeName': 'Dilbur', 'Initials': 'D', 'LastName': 'Arsiwalla', 'Affiliation': 'Department of Psychology, University of Northern Iowa, Cedar Falls, IA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Bubb', 'Affiliation': 'Department of Human Development and Family Studies, Auburn University, Auburn, AL.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2014.03.001']
920,31138465,Cardiopulmonary Bypass Priming with Hydroxyethyl Starch 6% 130/0.4 or Sodium Chloride 0.9%: A Preliminary Double-Blind Randomized Controlled Study in Cardiac Surgery.,,2019,,[],['Hydroxyethyl Starch 6% 130/0.4 or Sodium Chloride 0.9'],[],[],"[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}]",[],,0.348423,,"[{'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Schweizer', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Lameche', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Coelembier', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Portran', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fornier', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Colombet', 'Affiliation': 'Service de Pharmacie Hospitalière, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grinberg', 'Affiliation': 'Service de Chirurgie Cardiaque, Vasculaire et Thoracique, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pozzi', 'Affiliation': 'Service de Chirurgie Cardiaque, Vasculaire et Thoracique, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Jacquet-Lagrèze', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Fellahi', 'Affiliation': ""Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France; IHU OPERA Cardioprotection, Université Claude Bernard Lyon 1, Lyon, France.""}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.05.003']
921,25753445,FAmily-Led RehabiliTaTion aftEr Stroke in INDia: the ATTEND pilot study.,"BACKGROUND


The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care.
METHODS


A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133.
RESULTS


A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study.
CONCLUSION


The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial 'ATTEND' is currently underway in over 10 centers in India.",2015,"Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months.","['aftEr Stroke in INDia', '10 centers in India', 'patients with residual disability', '104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months']","['FAmily-Led RehabiliTaTion', 'family-led, trained caregiver-delivered, home-based stroke rehabilitation', 'trained caregiver-delivered, home-based rehabilitation intervention vs. routine care', 'structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control']",[],"[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C0344346', 'cui_str': 'Christian, follower of religion (person)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],104.0,0.158409,"Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months.","[{'ForeName': 'Jeyaraj D', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Felix', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Paramdeep', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Lizzie', 'Initials': 'L', 'LastName': 'Julia', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Toor', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Rajni', 'Initials': 'R', 'LastName': 'Arora', 'Affiliation': 'Department of Physiotherapy, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Dorcas B C', 'Initials': 'DB', 'LastName': 'Gandhi', 'Affiliation': 'Department of Physiotherapy, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Shweta J', 'Initials': 'SJ', 'LastName': 'Verma', 'Affiliation': 'Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'G V S', 'Initials': 'GV', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health Hyderabad, Public Health Foundation of India, Hyderabad, India.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alim', 'Affiliation': 'The George Institute for Global Health, Hyderabad, India.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'Sydney Medical School/Northern, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'University of Leeds, Bradford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health, University of Sydney, Sydney, New South Wales, Australia.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1111/ijs.12475']
922,32425062,The predictive value of procalcitonin in ventilator-associated pneumonia after cardiac valve replacement.,"This study aimed to evaluate the predictive value of procalcitonin (PCT) in ventilator-associated pneumonia (VAP) after cardiac valve replacement. A total of 80 patients who underwent cardiac valve replacement in our department were enrolled in this study. Of these patients,40 were diagnosed with VAP and assigned to the observation group, while the other 40 patients not diagnosed with VAP were assigned to the control group. The changes in serum PCT, white blood cell count and C-reactive protein (CRP) were observed before each operation (T0), on the first day after the operation (T1), the second day after the operation (T2) and the third day after the operation (T3). After the operation, the serum PCT in the observation group was significantly higher than those at different time points after the operation, and also significantly higher than those in the control group ( p  < .05). In the control group, PCT was significantly higher after the operation than before the operation ( p  < .05), but the differences among the different postoperative time points were not statistically significant ( p  > .05). In the two groups, the white blood cell count and CRP were significantly higher after the operation than before the operation ( p  < .05), but the differences between the two groups were not statistically significant ( p  > .05). Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.",2020,"Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.","['ventilator-associated pneumonia (VAP) after cardiac valve replacement', '80 patients who underwent cardiac valve replacement in our department were enrolled in this study', '40 patients not diagnosed with VAP', 'ventilator-associated pneumonia after cardiac valve replacement']",['procalcitonin (PCT'],"['serum PCT', 'serum PCT, white blood cell count and C-reactive protein (CRP', 'PCT', 'white blood cell count and CRP']","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0072027', 'cui_str': 'Procalcitonin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",80.0,0.0145082,"Serum PCT is an early, sensitive and highly specific high-risk monitoring index and has an early prediction value for VAP after cardiac valve replacement.","[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Song', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ji-Wei', 'Initials': 'JW', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Ningxia Medical University, Yinchuan, China.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1762242']
923,32425361,"Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.","BACKGROUND


Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza.
PURPOSE


To determine the safety and efficacy of LH capsule in patients with Covid-19.
METHODS


We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery.
RESULTS


We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported.
CONCLUSION


In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.",2020,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%,  P <0.001) and clinical cure (78.9% vs. 66.2%,  P= 0.017) was also higher in treatment group.","['patients with Covid-19', '284 patients (142 each in treatment and control group) in the full-analysis set', 'Patients with Coronavirus disease 2019']","['LH capsule', 'Lianhuaqingwen Capsules, a repurposed Chinese Herb', 'usual treatment alone or in combination with LH capsules']","['Efficacy and Safety', 'rate of improvement in chest computed tomographic manifestations', 'coughing', 'Time to recovery of fever', 'fatigue', 'rate of symptom (fever, fatigue, coughing) recovery', 'rate of conversion to severe cases or viral assay findings', 'clinical cure', 'safety and efficacy', 'serious adverse events', 'median time to symptom recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",284.0,0.213016,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%,  P <0.001) and clinical cure (78.9% vs. 66.2%,  P= 0.017) was also higher in treatment group.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035 PR China. Electronic address: jzhjiazhenhua@163.com.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China. Electronic address: nanshan@vip.163.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153242']
924,32420683,"Discovery of Intake Biomarkers of Lentils, Chickpeas, and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine.","SCOPE


To identify reliable biomarkers of food intake (BFIs) of pulses.
METHODS AND RESULTS


A randomized crossover postprandial intervention study is conducted on 11 volunteers who consumed lentils, chickpeas, and white beans. Urine and serum samples are collected at distinct postprandial time points up to 48 h, and analyzed by LC-HR-MS untargeted metabolomics. Hypaphorine, trigonelline, several small peptides, and polyphenol-derived metabolites prove to be the most discriminating urinary metabolites. Two arginine-related compounds, dopamine sulfate and epicatechin metabolites, with their microbial derivatives, are identified only after intake of lentils, whereas protocatechuic acid is identified only after consumption of chickpeas. Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, are found after white bean consumption. Most of the metabolites identified in the postprandial study are replicated as discriminants in 24 h urine samples, demonstrating that in this case the use of a single, noninvasive sample is suitable for revealing the consumption of pulses.
CONCLUSIONS


The results of the present untargeted metabolomics work reveals a broad list of metabolites that are candidates for use as biomarkers of pulse intake. Further studies are needed to validate these BFIs and to find the best combinations of them to boost their specificity.",2020,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","['11 volunteers who consumed lentils, chickpeas and white beans']","['Hypaphorine, trigonelline', 'dopamine sulfate and epicatechin metabolites']",['Urine and serum samples'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0446305', 'cui_str': 'White bean'}]","[{'cui': 'C0064754', 'cui_str': 'lenticin'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}]",11.0,0.0132396,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Garcia-Aloy', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Marynka', 'Initials': 'M', 'LastName': 'Ulaszewska', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Center for Omics Sciences, Proteomics and Metabolomics Facility - ProMeFa, Milan, 20132, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Franceschi', 'Affiliation': ""Computational Biology Unit, Research and Innovation Center, Fondazione Edmund Mach, San Michele all'Adige, 38010, Italy.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Estruel-Amades', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Christoph H', 'Initials': 'CH', 'LastName': 'Weinert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Federal Research Institute of Nutrition and Food, Karlsruhe, 76131, Germany.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Tor-Roca', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Urpi-Sarda', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Center, Fondazione Edmund Mach (FEM), San Michele all'Adige, 38010, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901137']
925,31999500,Therapeutic Potential of  Bauhinia forficata  Link in Dental Biofilm Treatment.,"The oral cytotoxicity, antimicrobial and anti-demineralizing effects of a tincture from  Bauhinia forficata  Link tincture (BFLT) were evaluated  in vitro  and  ex vivo . Susceptibility tests (minimum inhibitory and microbicidal concentrations-MIC and time-kill assay-MMC) were performed against planktonic oral microorganisms. The contents of phenolic compounds were investigated. Cytotoxic potential was evaluated on oral fibroblasts after 1-5 min exposure to BFLT. Blocks of sound bovine enamel ( N  = 60) were inoculated with a saliva pool and sustained in a multiple plaque growth system for 48 h to form a biofilm. Biofilm blocks were randomly divided into groups-G ( n  = 10): G1-Baseline (48 h maturation biofilm), G2-BFLT 23.2 mg/mL, G3-Ethanol 81.20 g/mL, G4-Chlorhexidine 0.12%, G5-Growth control, and G6-Blank control. Treatments (50  μ L/1 min) were performed once a day for a week.  Streptococcus  spp. (S) and total microorganism (TM) counts were expressed as Log 10  CFU/mL. Biofilm height was evaluated by confocal microscopy analyses (CMA). Final surface hardness was assessed and percentage of microhardness loss (% MHL) was calculated. Results were significant when  P  < .05. BFLT inhibited all tested microorganisms (MIC = 1.3-23.2 mg/mL) and promoted optical reduction (0.05-0.22 nm) of all microorganisms after 48-h treatment compared with controls. After 5-min treatment, BFLT showed low values of cell death (3.20%). G2-BFLT reduced S (6.61 ± 0.20) and TM (7.14 ± 0.38) compared with G1-Baseline (S = 7.82 ± 0.28; TM = 8.81 ± 0.67) and G5-Growth control (S = 7.48 ± 0.39; TM = 7.89 ± 0.68); but G4-chlororexidine (S = 6.11 ± 0.48; TM = 6.45 ± 0.16) showed the highest antibiofilm activity. CMA was not different among treatment groups. G2 showed lower % MHL compared with G5, although G4 presented the lowest. Results suggest BFLT is beneficial against dental caries, showing antimicrobial effects against a mature dental biofilm and no cytotoxicity.",2020,BFLT inhibited all tested microorganisms (MIC = 1.3-23.2 mg/mL) and promoted optical reduction (0.05-0.22 nm) of all microorganisms after 48-h treatment compared with controls.,[],"['BFLT', 'sound bovine enamel', 'G2-BFLT 23.2\u2009mg/mL, G3-Ethanol', 'G1-Baseline']","['S) and total microorganism (TM) counts', 'highest antibiofilm activity', 'optical reduction', 'Susceptibility tests (minimum inhibitory and microbicidal concentrations-MIC and time-kill assay-MMC', 'Cytotoxic potential', 'cell death', 'Final surface hardness', 'CMA']",[],"[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C4521706', 'cui_str': 'Cytotoxic'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}]",60.0,0.0274935,BFLT inhibited all tested microorganisms (MIC = 1.3-23.2 mg/mL) and promoted optical reduction (0.05-0.22 nm) of all microorganisms after 48-h treatment compared with controls.,"[{'ForeName': 'Julio Cesar C', 'Initials': 'JCC', 'LastName': 'Ferreira-Filho', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Andressa Temperini de Oliveira', 'Initials': 'ATO', 'LastName': 'Marre', 'Affiliation': 'Department of Medical Microbiology, Institute of Microbiology, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Juliana Soares', 'Initials': 'JS', 'LastName': 'de Sá Almeida', 'Affiliation': 'Department of Medical Microbiology, Institute of Microbiology, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Leandro de Araújo', 'Initials': 'LA', 'LastName': 'Lobo', 'Affiliation': 'Department of Medical Microbiology, Institute of Microbiology, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Farah', 'Affiliation': 'Institute of Nutrition, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Maria Teresa Villela', 'Initials': 'MTV', 'LastName': 'Romanos', 'Affiliation': 'Department of Virology, Institute of Microbiology, UFRJ, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Lucianne Cople', 'Initials': 'LC', 'LastName': 'Maia', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Ana Maria Gondim', 'Initials': 'AMG', 'LastName': 'Valença', 'Affiliation': 'Department of Clinic and Social Dentistry, School of Dentistry, Federal University of Paraíba (UFPB), João Pessoa, PB, Brazil.'}, {'ForeName': 'Andréa', 'Initials': 'A', 'LastName': 'Fonseca-Gonçalves', 'Affiliation': 'Department of Pediatric Dentistry and Orthodontics, School of Dentistry, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}]",Journal of medicinal food,['10.1089/jmf.2019.0277']
926,31816508,Online social support groups for informal caregivers of hospice patients with cancer.,"PURPOSE


Social support is an important factor in reducing caregiver burden, however, accessing social support via traditional means is often challenging for family caregivers of hospice patients. Online support groups may offer an effective solution. The present study sought to understand dynamics of online social support among family and other informal (e.g., friends) caregivers of hospice cancer patients in an online social support group. The primary aim of the study was to identify types of online social support and support-seeking behaviors, with a secondary aim to understand informal hospice caregivers' preferences for social support.
METHOD


Data used in this study were collected as part of a federally funded randomized clinical trial of an informal hospice cancer caregiver support intervention. Findings are based on directed and conventional content analysis of support group members' posts and comments-including text and images-and a sample of caregivers' exit interviews.
RESULTS


Analyses demonstrated that the majority of online support provided by group members was emotional support, followed by companionship support, appraisal support, and informational support. Instrumental support was rarely provided. Support was primarily elicited in an indirect manner through self-disclosure and patient updates, with few overt requests for support.
CONCLUSIONS


Findings suggest online social support groups can be a valuable resource for informal caregivers who are in need of emotional support and lack the ability to access face-to-face support groups. Clinical implications of this research to healthcare systems regarding the importance of incorporating nurses and other medical professionals as co-facilitators of online support groups are discussed.",2020,"CONCLUSIONS


Findings suggest online social support groups can be a valuable resource for informal caregivers who are in need of emotional support and lack the ability to access face-to-face support groups.","['informal caregivers of hospice patients with cancer', 'family caregivers of hospice patients', ""informal hospice caregivers' preferences for social support"", 'family and other informal (e.g., friends) caregivers of hospice cancer patients in an online social support group']","['informal hospice cancer caregiver support intervention', 'online social support and support-seeking behaviors']",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0150162', 'cui_str': 'Caregiver support (regime/therapy)'}, {'cui': 'C0037438'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],,0.0335399,"CONCLUSIONS


Findings suggest online social support groups can be a valuable resource for informal caregivers who are in need of emotional support and lack the ability to access face-to-face support groups.","[{'ForeName': 'Jacquelyn J', 'Initials': 'JJ', 'LastName': 'Benson', 'Affiliation': 'University of Missouri, Columbia, MO, USA. Electronic address: bensonjj@missouri.edu.'}, {'ForeName': 'Debra Parker', 'Initials': 'DP', 'LastName': 'Oliver', 'Affiliation': 'University of Missouri, Columbia, MO, USA. Electronic address: oliverdr@health.missouri.edu.'}, {'ForeName': 'Karla T', 'Initials': 'KT', 'LastName': 'Washington', 'Affiliation': 'University of Missouri, Columbia, MO, USA. Electronic address: washingtonkar@health.missouri.edu.'}, {'ForeName': 'Abigail J', 'Initials': 'AJ', 'LastName': 'Rolbiecki', 'Affiliation': 'University of Missouri, Columbia, MO, USA. Electronic address: rolbieckia@health.missouri.edu.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'Lombardo', 'Affiliation': 'University of Missouri, Columbia, MO, USA. Electronic address: cblnt4@health.missouri.edu.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Garza', 'Affiliation': 'University of Missouri, Columbia, MO, USA. Electronic address: jeg343@health.missouri.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA. Electronic address: gdemiris@upenn.edu.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2019.101698']
927,25231953,"Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.","BACKGROUND


The BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here.
PATIENTS AND METHODS


BOLERO-2 is a phase III, double-blind, randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo (PBO) + EXE 25 mg/day in postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs. The primary end point was PFS by local investigator assessment; OS was a key secondary end point.
RESULTS


At the time of data cutoff (3 October 2013), 410 deaths had occurred and 13 patients remained on treatment. Median OS in patients receiving EVE + EXE was 31.0 months [95% confidence interval (CI) 28.0-34.6 months] compared with 26.6 months (95% CI 22.6-33.1 months) in patients receiving PBO + EXE (hazard ratio = 0.89; 95% CI 0.73-1.10; log-rank P = 0.14). Poststudy treatments were received by 84% of patients in the EVE + EXE arm versus 90% of patients in the PBO + EXE arm. Types of poststudy therapies were balanced across arms, except for chemotherapy (53% EVE + EXE versus 63% PBO + EXE). No new safety concerns were identified.
CONCLUSIONS


In BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001). Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting.
TRIAL REGISTRATION NUMBER


NCT00863655.",2014,"In BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001).","['patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs', 'postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs']","['everolimus (EVE) to exemestane (EXE', 'placebo (PBO) + EXE', 'Everolimus plus exemestane', 'PBO + EXE', 'EVE + EXE', 'EVE 10 mg/day plus EXE']","['Median OS', 'overall survival (OS', 'progression-free survival (PFS', 'PFS by local investigator assessment; OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.286511,"In BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: martine.piccart@bordet.be.'}, {'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'Department of Breast Medical Oncology, Multidisciplinary Breast Cancer Research Program, University of Texas MD Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Institut de Cancérologie de l'Ouest, René Gauducheau, Centre de Recherche en Cancérologie, Nantes Saint Herblain, France.""}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Department of Medicine, Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lebrun', 'Affiliation': 'Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Noguchi', 'Affiliation': 'Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': 'Breast Cancer Centers, Memorial Cancer Institute, Hollywood.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Breast Oncology and Clinical Trials Education, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Deleu', 'Affiliation': 'Oncologic Centre, AZ Nikolaas, Sint-Niklaas, Belgium.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Burris', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'Centre des Maladies du Sein Deschênes-Fabia, CHU-Hôpital du Saint Sacrement, Québec, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shtivelband', 'Affiliation': 'Ironwood Cancer & Research Centers, Chandler.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Taran', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu456']
928,31529691,Randomized controlled trial of TDCS on cognition in 201 seniors with mild neurocognitive disorder.,"OBJECTIVE


To examine the efficacy and safety of combined transcranial direct current stimulation (tDCS) and working memory training (WMT) in enhancing the cognitive functions for individuals with mild neurocognitive disorder due to AD (NCD-AD).
METHODS


In this double-blind, sham-controlled randomized clinical trial (RCT), 201 patients with NCD-AD were randomly assigned for a 4-week intervention of either a combination of tDCS and WMT, sham tDCS and WMT, or tDCS and control cognitive training (CCT). Global cognition and domain-specific cognitive function were assessed before and after the intervention with Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog), category verbal fluency test, logical memory, digit, and visual span tests.
RESULTS


Study participants did not show intervention group differences in baseline demographics, or cognitive characteristics (ANOVA). Cognitive enhancement was found across three groups after 4 weeks intervention. Combined tDCS-WMT group showed significantly greater improvement compared with single-modality groups in delayed recall (P = 0.043, η 2   = 0.036) and working memory capacity (P = 0.04, η 2   = 0.038) at 4th week, and logical memory at 12th week (P = 0.042, η 2   = 0.037). Adverse events, including skin lesions (2.2%), were similar between groups.
INTERPRETATION


tDCS or WMT could be a safe, feasible, and effective intervention for individuals with NCD-AD. A combination of tDCS and WMT presents greater cognitive enhancement, which may highlight the potential synergistic effects of combined modality intervention on cognition.",2019,"Combined tDCS-WMT group showed significantly greater improvement compared with single-modality groups in delayed recall (P = 0.043, η 2   = 0.036) and working memory capacity (P = 0.04, η 2   = 0.038) at 4th week, and logical memory at 12th week (P = 0.042, η 2   = 0.037).","['201 seniors with mild neurocognitive disorder', 'individuals with mild neurocognitive disorder due to AD (NCD-AD', '201 patients with NCD-AD', 'individuals with NCD-AD']","['combined transcranial direct current stimulation (tDCS) and working memory training (WMT', 'TDCS', 'tDCS and WMT, sham tDCS and WMT, or tDCS and control cognitive training (CCT', 'tDCS and WMT', 'Combined tDCS-WMT']","['Adverse events, including skin lesions', 'working memory capacity', 'Cognitive enhancement', ""Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog), category verbal fluency test, logical memory, digit, and visual span tests"", 'delayed recall', 'baseline demographics, or cognitive characteristics (ANOVA', 'Global cognition and domain-specific cognitive function']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion (disorder)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0002780', 'cui_str': 'ANOVA'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",201.0,0.144839,"Combined tDCS-WMT group showed significantly greater improvement compared with single-modality groups in delayed recall (P = 0.043, η 2   = 0.036) and working memory capacity (P = 0.04, η 2   = 0.038) at 4th week, and logical memory at 12th week (P = 0.042, η 2   = 0.037).","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Sandra Sau Man', 'Initials': 'SSM', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Wai Chi', 'Initials': 'WC', 'LastName': 'Chan', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Cuichan', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Calvin Pak Wing', 'Initials': 'CPW', 'LastName': 'Cheng', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Lam', 'Initials': 'L', 'LastName': 'Linda Chiu Wa', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong SAR, China.'}]",Annals of clinical and translational neurology,['10.1002/acn3.50823']
929,24220044,"Training in methods of preventing childhood obesity increases self-efficacy in nurses in child health services: a randomized, controlled trial.","OBJECTIVE


To evaluate the effects of training in methods of preventing childhood obesity on self-efficacy (SE) in nurses.
METHODS


In a randomized, controlled trial conducted in child health services in Sweden, nurses in the intervention and control groups of the PRIMROSE prevention trial of childhood obesity were offered a 5-day workshop on dietary and physical activity interventions, and motivational interviewing. Self-efficacy for influencing parents to promote healthy dietary and physical activity behaviors in their children was measured using an 18-item instrument. Difference in SE between groups at post-assessment was analyzed using multiple linear regression analysis.
RESULTS


Compared to control nurses (n = 38), intervention nurses (n = 22) demonstrated higher SE (β = 14.70, P < .001).
CONCLUSIONS AND IMPLICATIONS


Training in methods of preventing childhood obesity increased SE in nurses. Self-efficacy should be included as a construct in evaluations of clinical training.",2014,"Compared to control nurses (n = 38), intervention nurses (n = 22) demonstrated higher SE (β = 14.70, P < .001).
","['nurses', 'nurses in child health services', 'child health services in Sweden, nurses in the intervention and control groups of the PRIMROSE prevention trial of childhood obesity']","['5-day workshop on dietary and physical activity interventions, and motivational interviewing']","['healthy dietary and physical activity behaviors', 'Self-efficacy']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0008079', 'cui_str': 'Child Health Services'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0330455', 'cui_str': 'Primrose'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",38.0,0.0432698,"Compared to control nurses (n = 38), intervention nurses (n = 22) demonstrated higher SE (β = 14.70, P < .001).
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Bohman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: benjamin.bohman@ki.se.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Ghaderi', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2013.10.006']
930,25007003,"Efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar depression with generalized anxiety disorder and other comorbidities: a randomized, placebo-controlled trial.","OBJECTIVE


To study the efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities.
METHOD


The study was conducted from January 2007 to November 2011. The Mini-International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV bipolar disorder, GAD, and other Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. The Hamilton Depression Rating Scale-17 items (HDRS-17) was used as a primary outcome to evaluate the difference between the 2 groups using the change from baseline to end of study. Last observation carried forward and mixed-effects modeling for repeated measures were used to analyze the primary and secondary outcome measures.
RESULTS


Of the 120 patients screened, 100 patients were randomized to receive quetiapine-XR (n = 50) or placebo (n = 50). Twenty-six patients in the quetiapine-XR and 18 in the placebo group completed the study. The mean quetiapine-XR dose was 276 ± 50 mg/d (50-300 mg/d). There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR. There were also no significant differences between the 2 groups in secondary efficacy and safety outcome measures.
CONCLUSIONS


Quetiapine-XR was not significantly superior to placebo in bipolar I or II depression with GAD and other comorbidities, suggesting that data from relatively ""pure"" bipolar patients may not be generalizable to a highly comorbid population.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00671853.",2014,There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR.,"['100 patients', 'Twenty-six patients in the', 'Eligible patients', '120 patients screened', 'January 2007 to November 2011', 'acute bipolar depression with generalized anxiety disorder and other comorbidities', 'acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities']","['Quetiapine-XR', 'quetiapine-XR', 'placebo', 'quetiapine-XR or placebo']","['Efficacy and safety', 'HDRS-17 total score', 'secondary efficacy and safety outcome measures', 'Hamilton Depression Rating Scale-17 items (HDRS-17']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",100.0,0.0826703,There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR.,"[{'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University School of Medicine, 10524 Euclid Ave, 12th floor, Cleveland, OH 44106 keming.gao@uhhospitals.org.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kemp', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karberg', 'Affiliation': ''}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Conroy', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Serrano', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ganocy', 'Affiliation': ''}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.13m08847']
931,29313415,A Controlled Trial of Extended-Release Guanfacine and Psychostimulants on Executive Function and ADHD.,"Objective:  To evaluate the effectiveness of guanfacine extended-release (GXR) versus placebo as adjunct therapy to usual care stimulant therapy in improving executive function in children aged 6 to 12 years diagnosed with ADHD.  Method:  In this single center, double-blind placebo-controlled crossover trial, subjects continued to take their psychostimulant and were randomly assigned at baseline to receive active treatment or placebo first. Efficacy measures included Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales. Safety measures included adverse events and vital signs.  Results:  Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p  value = .0392), ADHD-RS-IV ( p  < .0001), CGI-S ( p  = .0007), and CGI-I ( p  = .003). There were no serious adverse events and no new safety signals.  Conclusion:  Use of GXR as adjunctive therapy to stimulant therapy significantly improves executive function in children with ADHD.",2020,"RESULTS


Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003).","['children aged 6 to 12 years diagnosed with ADHD', 'children with ADHD']","['guanfacine extended-release (GXR) versus placebo', 'GXR', 'placebo', 'Guanfacine']","['Behavioural Rating Inventory of Executive Function (BRIEF-P), ADHD Rating Scale IV (ADHD-RS IV), and Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) scales', 'Executive Function and ADHD', 'BRIEF-P', 'adverse events and vital signs', 'serious adverse events', 'executive function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}]",,0.132221,"RESULTS


Significant benefits of GXR plus psychostimulant were observed on BRIEF-P ( p value = .0392), ADHD-RS-IV ( p < .0001), CGI-S ( p = .0007), and CGI-I ( p = .003).","[{'ForeName': 'Judy P M', 'Initials': 'JPM', 'LastName': 'van Stralen', 'Affiliation': 'Center for Pediatric Excellence, Ottawa, Ontario, Canada.'}]",Journal of attention disorders,['10.1177/1087054717751197']
932,32087839,Adolescent SBIRT implementation: Generalist vs. Specialist models of service delivery in primary care.,"BACKGROUND


Drug, alcohol, and tobacco use among adolescents pose significant short- and long-term health consequences and are associated with more severe use as adults. Screening, brief intervention, and referral to treatment in primary care settings has the potential to deliver preventive interventions to a diverse range of adolescents, but optimal implementation of these services needs to be determined. The purpose of this study was to compare implementation of two different SBIRT service delivery models in primary care settings.
METHODS


This cluster-randomized trial assigned 7 primary care clinics of a federally qualified health center to implement brief interventions (BI) using a Generalist model (4 sites), in which BIs were delivered by the primary care provider (PCP), or a Specialist model (3 sites), in which BIs were delivered by a behavioral health counselor (BHC) for adolescent patients ages 12-17 years. Implementation was tracked through the clinic's electronic health record, spanning 9639 clinic visits over 20 months. Multilevel logistic regression modeling was used to compare Generalist and Specialist strategies on penetration of BI for patients scoring ≥2 on the CRAFFT substance use screen, delivered by the PCP in the Generalist sites, and via warm hand-off to a BHC in the Specialist sites.
RESULTS


Approximately 62% of adolescent patient visits were screened with the CRAFFT (with <4% screening positive with a CRAFFT score ≥ 2). The Generalist Condition had significantly higher self-reported penetration of BI delivery than the Specialist Condition (38% vs. 8%; Adjusted Odds Ratio = 6.53; p = .005).
DISCUSSION


Despite having co-located behavioral health services at all sites, a Specialist approach to providing BI was less effectively implemented than a Generalist approach in this FQHC. BI delivered by PCPs rather than by hand-off to a BHC may ensure greater penetration of these services in primary care settings. Both implementation models provided a framework for identifying and intervening with adolescent primary care patients whose substance use might have otherwise gone undetected.",2020,The Generalist Condition had significantly higher self-reported penetration of BI delivery than the Specialist Condition (38% vs. 8%; Adjusted Odds Ratio = ,"['primary care settings', 'adolescent patients ages 12-17\xa0years', '7 primary care clinics of a federally qualified health center to']","['CRAFFT', 'implement brief interventions (BI) using a Generalist model (4 sites), in which BIs were delivered by the primary care provider (PCP), or a Specialist model (3 sites), in which BIs were delivered by a behavioral health counselor (BHC']",['self-reported penetration of BI delivery'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",7.0,0.017035,The Generalist Condition had significantly higher self-reported penetration of BI delivery than the Specialist Condition (38% vs. 8%; Adjusted Odds Ratio = ,"[{'ForeName': 'Shannon Gwin', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, Baltimore, MD, United States of America. Electronic address: smitchell@friendsresearch.org.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gryczynski', 'Affiliation': 'Friends Research Institute, Baltimore, MD, United States of America.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, Baltimore, MD, United States of America.'}, {'ForeName': 'Arethusa S', 'Initials': 'AS', 'LastName': 'Kirk', 'Affiliation': 'Total Health Care, Baltimore, MD, United States of America.'}, {'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Dusek', 'Affiliation': 'Friends Research Institute, Baltimore, MD, United States of America.'}, {'ForeName': 'Marla', 'Initials': 'M', 'LastName': 'Oros', 'Affiliation': 'Mosaic Group, Baltimore, MD, United States of America.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Hosler', 'Affiliation': 'University of Maryland Baltimore County, United States of America.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'University of Maryland, College Park, College Park, MD, United States of America.'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Brown', 'Affiliation': 'University of North Carolina at Wilmington, Wilmington, NC, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.01.007']
933,24368367,Advantages and pitfalls of combining intravenous antithrombin with nebulized heparin and tissue plasminogen activator in acute respiratory distress syndrome.,"BACKGROUND


Pulmonary coagulopathy has become an important therapeutic target in adult respiratory distress syndrome (ARDS). We hypothesized that combining intravenous recombinant human antithrombin (rhAT), nebulized heparin, and nebulized tissue plasminogen activator (TPA) more effectively improves pulmonary gas exchange compared with a single rhAT infusion, while maintaining the anti-inflammatory properties of rhAT in ARDS. Therefore, the present prospective, randomized experiment was conducted using an established ovine model.
METHODS


Following burn and smoke inhalation injury (40% of total body surface area, third-degree flame burn, and 4 × 12 breaths of cold cotton smoke), 18 chronically instrumented sheep were randomly assigned to receive intravenous saline plus saline nebulization (control), intravenous rhAT (6 IU/kg/h) started 1 hour after injury plus saline nebulization (AT i.v.) or intravenous rhAT combined with nebulized heparin (10,000 IU every 4 hours, started 2 hours after injury), and nebulized TPA (2 mg every 4 hours, started 4 hours after injury) (triple therapy, n = 6 each). All animals were mechanically ventilated and fluid resuscitated according to standard protocols during the 48-hour study period.
RESULTS


Both treatment approaches attenuated ARDS compared with control animals. Notably, triple therapy was associated with an improved PaO2/FiO2 ratio (p = 0.007), attenuated pulmonary obstruction (p = 0.02) and shunting (p = 0.025), as well as reduced ventilatory pressures (p < 0.05 each) versus AT i.v. at 48 hours. However, the anti-inflammatory effects of sole AT i.v., namely, the inhibition of neutrophil activation (neutrophil count in the lymph and pulmonary polymorphonuclear cells, p < 0.05 vs. control each), pulmonary transvascular fluid flux (lymph flow, p = 0.004 vs. control), and systemic vascular leakage (cumulative net fluid balance, p < 0.001 vs. control), were abolished in the triple therapy group.
CONCLUSION


Combining intravenous rhAT with nebulized heparin and nebulized TPA more effectively restores pulmonary gas exchange, but the anti-inflammatory effects of sole rhAT are abolished with the triple therapy. Interferences between the different anticoagulants may represent a potential explanation for these findings.",2014,"Notably, triple therapy was associated with an improved PaO2/FiO2 ratio (p = 0.007), attenuated pulmonary obstruction (p = 0.02) and shunting (p = 0.025), as well as reduced ventilatory pressures (p < 0.05 each) versus AT i.v. at 48 hours.","['Following burn and smoke inhalation injury (40% of total body surface area, third-degree flame burn, and 4 × 12 breaths of cold cotton smoke', 'adult respiratory distress syndrome (ARDS', '18 chronically instrumented sheep', 'acute respiratory distress syndrome']","['intravenous saline plus saline nebulization (control), intravenous rhAT', 'nebulized TPA', 'antithrombin with nebulized heparin and tissue plasminogen activator', 'nebulized heparin and nebulized TPA', 'recombinant human antithrombin (rhAT), nebulized heparin, and nebulized tissue plasminogen activator (TPA', 'intravenous rhAT combined with nebulized heparin']","['improved PaO2/FiO2 ratio', 'reduced ventilatory pressures', 'pulmonary obstruction', 'ARDS', 'pulmonary transvascular fluid flux (lymph flow', 'inhibition of neutrophil activation (neutrophil count', 'systemic vascular leakage']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0037367', 'cui_str': 'Smoke Inhalation Injury'}, {'cui': 'C0445175', 'cui_str': '% of total body surface (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0443323', 'cui_str': 'Third degree (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0036945', 'cui_str': 'Ovis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0024202', 'cui_str': 'Lymph'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0242599', 'cui_str': 'Neutrophil Activation'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}]",,0.143928,"Notably, triple therapy was associated with an improved PaO2/FiO2 ratio (p = 0.007), attenuated pulmonary obstruction (p = 0.02) and shunting (p = 0.025), as well as reduced ventilatory pressures (p < 0.05 each) versus AT i.v. at 48 hours.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Rehberg', 'Affiliation': 'From the Investigational Intensive Care Unit (S.R., Y.Y., L.E.S., C.J., D.S.P., P.E.), Department of Anesthesiology, and Department of Pathology (R.A.C.), The University of Texas Medical Branch; and Shriners Hospital for Children (R.A.C., P.E.), Galveston, Texas; and Department of Anesthesiology, Intensive Care and Pain Medicine (S.R.), University of Muenster, Muenster, Germany.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Sousse', 'Affiliation': ''}, {'ForeName': 'Collette', 'Initials': 'C', 'LastName': 'Jonkam', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Prough', 'Affiliation': ''}, {'ForeName': 'Perenlei', 'Initials': 'P', 'LastName': 'Enkhbaatar', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0b013e3182ab0785']
934,32065601,Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial.,"Importance


Prevention of postcontrast acute kidney injury in patients with stage 3 chronic kidney disease (CKD) by means of prehydration has been standard care for years. However, evidence for the need for prehydration in this group is limited.
Objective


To assess the renal safety of omitting prophylactic prehydration prior to iodine-based contrast media administration in patients with stage 3 CKD.
Design, Setting, and Participants


The Kompas trial was a multicenter, noninferiority, randomized clinical trial conducted at 6 hospitals in the Netherlands in which 523 patients with stage 3 CKD were randomized in a 1:1 ratio to receive no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate administered in a 1-hour infusion before undergoing elective contrast-enhanced computed tomography from April 2013 through September 2016. Final follow-up was completed in September 2017. Data were analyzed from January 2018 to June 2019.
Interventions


In total, 262 patients were allocated to the no prehydration group and 261 were allocated to receive prehydration. Analysis on the primary end point was available in 505 patients (96.6%).
Main Outcomes and Measures


The primary end point was the mean relative increase in serum creatinine level 2 to 5 days after contrast administration compared with baseline (noninferiority margin of less than 10% increase in serum creatinine level). Secondary outcomes included the incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs.
Results


Of 554 patients randomized, 523 were included in the intention-to-treat analysis. The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women. The mean (SD) relative increase in creatinine level 2 to 5 days after contrast administration compared with baseline was 3.0% (10.5) in the no prehydration group vs 3.5% (10.3) in the prehydration group (mean difference, 0.5; 95% CI, -1.3 to 2.3; P < .001 for noninferiority). Postcontrast acute kidney injury occurred in 11 patients (2.1%), including 7 of 262 (2.7%) in the no prehydration group and 4 of 261 (1.5%) in the prehydration group, which resulted in a relative risk of 1.7 (95% CI, 0.5-5.9; P = .36). None of the patients required dialysis or developed acute heart failure. Subgroup analyses showed no evidence of statistical interactions between treatment arms and predefined subgroups. Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001). Other health care costs were similar.
Conclusions and Relevance


Among patients with stage 3 CKD undergoing contrast-enhanced computed tomography, withholding prehydration did not compromise patient safety. The findings of this study support the option of not giving prehydration as a safe and cost-efficient measure.
Trial Registration


Netherlands Trial Register Identifier: NTR3764.",2020,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"['6 hospitals in the Netherlands in which 523 patients with stage 3 CKD', '262 patients', 'patients with stage', 'The median (interquartile range) age was 74 (67-79) years; 336 (64.2%) were men and 187 (35.8%) were women', 'patients with stage 3 CKD', 'patients with stage 3 chronic kidney disease (CKD', 'Adults With Chronic Kidney Disease', '554 patients randomized', 'Data were analyzed from January 2018 to June 2019']","['prehydration', 'no prehydration or prehydration with 250 mL of 1.4% sodium bicarbonate', 'omitting prophylactic prehydration prior to iodine-based contrast media administration', 'Contrast-Enhanced Computed Tomography', 'No Prehydration vs Sodium Bicarbonate Prehydration']","['incidence of postcontrast acute kidney injury 2 to 5 days after contrast administration, mean relative increase in creatinine level 7 to 14 days after contrast administration, incidences of acute heart failure and renal failure requiring dialysis, and health care costs', 'Postcontrast acute kidney injury', 'Mean hydration costs', 'serum creatinine level', 'mean (SD) relative increase in creatinine level', 'renal safety', 'safe and cost-efficient measure', 'acute heart failure']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442799', 'cui_str': 'Efficient (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",262.0,0.201305,Mean hydration costs were €119 (US $143.94) per patient in the prehydration group compared with €0 (US $0) in the no prehydration group (P < .001).,"[{'ForeName': 'Rohit J', 'Initials': 'RJ', 'LastName': 'Timal', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kooiman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yvo W J', 'Initials': 'YWJ', 'LastName': 'Sijpkens', 'Affiliation': 'Department of Internal Medicine, Haaglanden Medisch Centrum Bronovo, The Hague, the Netherlands.'}, {'ForeName': 'Jean-Paul P M', 'Initials': 'JPM', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Surgery, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Iris J A M', 'Initials': 'IJAM', 'LastName': 'Verberk-Jonkers', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Harald F H', 'Initials': 'HFH', 'LastName': 'Brulez', 'Affiliation': 'Department of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'van Buren', 'Affiliation': 'Department of Internal Medicine, Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'van der Molen', 'Affiliation': 'Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Cannegieter', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Ton J', 'Initials': 'TJ', 'LastName': 'Rabelink', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.7428']
935,23804582,Sex steroid levels and response to weight loss interventions among postmenopausal women in the diabetes prevention program.,"OBJECTIVES


To examine whether estrogen use potentiates weight loss interventions via sex steroid levels and whether endogenous sex steroid levels predict response to weight loss interventions among women not using estrogen.
METHODS


The Diabetes Prevention Program randomized overweight or obese dysglycemic participants to lifestyle change with the goals of weight reduction of >7% of initial weight and 150 minutes per week of exercise, metformin, or placebo. In this secondary analysis, we examined sex steroid levels and reductions in weight and waist circumference (WC) among postmenopausal women using (n = 324) and not using (n = 382) oral estrogen.
RESULTS


Estrogen users and nonusers randomized to lifestyle change and metformin both lost significant amounts of weight compared to placebo. Reductions in weight and WC over 1 year associated with randomization arm were not associated with baseline sex steroid levels among estrogen users or nonusers.
CONCLUSIONS


Among estrogen users, baseline sex steroids were not associated with reductions in weight or WC, suggesting that exogenous estrogen does not potentiate weight loss by altering sex steroids. Among nonestrogen users, baseline sex steroids were not associated with reductions in weight or WC.",2014,"Reductions in weight and WC over 1 year associated with randomization arm were not associated with baseline sex steroid levels among estrogen users or nonusers.
","['postmenopausal women in the diabetes prevention program', 'women not using estrogen', 'postmenopausal women using (n\u2009=\u2009324) and not using (n\u2009=\u2009382) oral estrogen']","['placebo', 'exercise, metformin, or placebo']","['Sex steroid levels and response to weight loss interventions', 'sex steroid levels and reductions in weight and waist circumference (WC', 'weight loss', 'weight or WC', 'weight and WC']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]",,0.0358016,"Reductions in weight and WC over 1 year associated with randomization arm were not associated with baseline sex steroid levels among estrogen users or nonusers.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Departments of Medicine and Obstetrics & Gynecology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Barrett-Connor', 'Affiliation': ''}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Randolph', 'Affiliation': ''}, {'ForeName': 'Shengchun', 'Initials': 'S', 'LastName': 'Kong', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Nan', 'Affiliation': ''}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': ''}, {'ForeName': 'Sherita H', 'Initials': 'SH', 'LastName': 'Golden', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.20527']
936,31468988,The impact of relocation stress on cognitively impaired and cognitively unimpaired long-term care residents.,"Objectives:  The current aims were to explore the effects of relocation stress on depression and anxiety in long-term care residents and to investigate the moderating effect of cognitive status.  Methods:  The study used existing data from nursing home and congregate apartment residents. Self-reported measures of relocation stress, cognitive status, depression, and anxiety were examined. Exploratory analyses examined group differences in depression and anxiety within the full sample ( n  = 568) and the sample of first-year residents ( n  = 347). Main analyses were conducted in a subsample of 107 first-year residents who completed the measure of relocation stress.  Results:  Residents who had moved in the past year reported more anxiety but not depression than longer-term residents. Relocation stress significantly predicted depression but not anxiety in the subsample of first-year residents. There was no significant effect of cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety.  Conclusion:  Findings suggest that cognitively impaired older adults are no more vulnerable to the negative effects of relocation stress than cognitively unimpaired older adults. Relocation stress should be regarded as a risk factor for depression in long-term care residents, regardless of cognitive status, in the first year after relocation.",2019,There was no significant effect of cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety.  ,"['Results:  Residents who had moved in the past year', 'subsample of 107 first-year residents who completed the measure of relocation stress', 'cognitively unimpaired older adults', 'nursing home and congregate apartment residents', 'cognitively impaired older adults', 'within the full sample ( n \u2009=\u2009568) and the sample of first-year residents ( n \u2009=\u2009347', 'cognitively impaired and cognitively unimpaired long-term care residents']",['relocation stress'],"['relocation stress, cognitive status, depression, and anxiety', 'depression and anxiety', 'cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety', 'anxiety']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0457933', 'cui_str': 'Residential flat'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0023977'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",568.0,0.0172567,There was no significant effect of cognitive status or the interaction of cognitive status and relocation stress on depression and anxiety.  ,"[{'ForeName': 'Kyrsten', 'Initials': 'K', 'LastName': 'Costlow', 'Affiliation': 'Alabama Research Institute on Aging and Department of Psychology, University of Alabama , Tuscaloosa , AL , USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Parmelee', 'Affiliation': 'Alabama Research Institute on Aging and Department of Psychology, University of Alabama , Tuscaloosa , AL , USA.'}]",Aging & mental health,['10.1080/13607863.2019.1660855']
937,31464476,Response to nicotine following overnight smoking abstinence during short-term progesterone treatment in women.,"Preclinical and clinical literature suggest that sex hormones impact tobacco use behaviors in women. The goal of this double-blind crossover laboratory study was to examine the effect of oral exogenous progesterone (200 mg twice per day) versus placebo on nicotine response using measures of motor speed and cognitive function in women following overnight smoking abstinence. We hypothesized that increased progesterone would blunt the nicotine response whereby producing less change in motor speed and cognition in response to nicotine exposure. Female smokers, age 18-35, were randomized to participate in two 9-day crossover testing weeks. Participants completed a lab session following overnight abstinence where they were administered nicotine nasal spray and asked to complete measures of immediate memory (IMT), delayed memory (DMT), word recall (WR), and finger tapping speed (FT). After the first 9-day testing week, participants resumed smoking and returned the following month to complete the identical lab session in the crossover condition. Forty-seven women were included in this analysis (n = 47). We found no differences in the magnitude of response for IMT, DMT, and WR between conditions. For FT, women had a blunted response to nicotine during the placebo condition. When examining the association between hormone levels and relative performance, we found increases in DMT, WR, and FT but decreases in IMT during the progesterone condition. We observed differences between progesterone versus placebo in relative change in some measures of nicotine response following overnight abstinence. Future studies are needed to further characterize this response. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"We found no differences in the magnitude of response for IMT, DMT, and WR between conditions.","['Female smokers, age 18-35', 'women following overnight smoking abstinence', 'women', 'Forty-seven women were included in this analysis (n = 47']","['progesterone versus placebo', 'placebo', 'oral exogenous progesterone', 'nicotine', 'nicotine nasal spray']","['immediate memory (IMT), delayed memory (DMT), word recall (WR), and finger tapping speed (FT', 'motor speed and cognitive function', 'DMT, WR, and FT', 'overnight smoking abstinence']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3192374', 'cui_str': 'Nicotine Nasal Spray'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0027183', 'cui_str': 'Dimethyltryptamine'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",47.0,0.0981361,"We found no differences in the magnitude of response for IMT, DMT, and WR between conditions.","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine & Community Health.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine & Community Health, University of Minnesota.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tosun', 'Affiliation': 'Department of Family Medicine & Community Health, University of Minnesota.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Cameron', 'Affiliation': 'William Beaumont School of Medicine, Oakland University.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000312']
938,23905525,Body mass index is a stronger predictor than the metabolic syndrome for future asthma in women. The longitudinal CARDIA study.,"RATIONALE


It is hypothesized that the metabolic syndrome explains the association between body mass index (BMI) and asthma in adults.
OBJECTIVES


Our objective was to longitudinally compare the relative strengths of the associations of the metabolic syndrome and BMI with incident asthma in adults.
METHODS


We included 4,619 eligible participants in the Coronary Artery Risk Development in Young Adults (CARDIA) cohort followed over 25 years. Incident asthma was defined by a new self-reported provider asthma diagnosis plus either the presence of asthma symptoms and/or use of asthma medications. Cox proportional hazard analyses were performed.
MEASUREMENTS AND MAIN RESULTS


Six hundred two subjects (417 women and 185 men) developed incident asthma over 25 years of follow-up. Metabolic syndrome predicted incident asthma among women but not men (unadjusted hazard ratios, 1.50 and 0.98; P = 0.01 and 0.93, respectively). BMI had a similar predictive association among women but not men (unadjusted hazard ratios, 1.19 and 1.04 per 5 units of BMI; P < 0.001 and 0.60, respectively). The association of metabolic syndrome with incident asthma in women was no longer statistically significant after adjustment for BMI (P = 0.44). In contrast, the association of BMI with incident asthma in women remained statistically significant after adjusting for the metabolic syndrome (P = 0.01). In a stepwise model, BMI was a stronger predictor than the metabolic syndrome (P = 0.001).
CONCLUSIONS


BMI is a stronger predictor of incident asthma among women than the metabolic syndrome. Other obesity-associated factors that are not a part of the metabolic syndrome may play a role in the BMI-asthma association in women.",2013,"Metabolic syndrome predicted incident asthma among women but not men (unadjusted hazard ratios, 1.50 and 0.98; P = 0.01 and 0.93, respectively).","['4,619 eligible participants in the Coronary Artery Risk Development in Young Adults (CARDIA) cohort followed over 25 years', 'adults', 'Six hundred two subjects (417 women and 185 men) developed incident asthma over 25 years of follow-up']",[],[],"[{'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],[],4619.0,0.0322454,"Metabolic syndrome predicted incident asthma among women but not men (unadjusted hazard ratios, 1.50 and 0.98; P = 0.01 and 0.93, respectively).","[{'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Assad', 'Affiliation': 'Department of Medicine, University of New Mexico Health Sciences Center School of Medicine, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': ''}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Arynchyn', 'Affiliation': ''}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Thyagarajan', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schuyler', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Jacobs', 'Affiliation': ''}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201303-0457OC']
939,30590537,Human Direct Skin Feeding Versus Membrane Feeding to Assess the Mosquitocidal Efficacy of High-Dose Ivermectin (IVERMAL Trial).,"BACKGROUND


Ivermectin is being considered for mass drug administration for malaria, due to its ability to kill mosquitoes feeding on recently treated individuals. In a recent trial, 3-day courses of 300 and 600 mcg/kg/day were shown to kill Anopheles mosquitoes for at least 28 days post-treatment when fed patients' venous blood using membrane feeding assays. Direct skin feeding on humans may lead to higher mosquito mortality, as ivermectin capillary concentrations are higher. We compared mosquito mortality following direct skin and membrane feeding.
METHODS


We conducted a mosquito feeding study, nested within a randomized, double-blind, placebo-controlled trial of 141 adults with uncomplicated malaria in Kenya, comparing 3 days of ivermectin 300 mcg/kg/day, ivermectin 600 mcg/kg/day, or placebo, all co-administered with 3 days of dihydroartemisinin-piperaquine. On post-treatment day 7, direct skin and membrane feeding assays were conducted using laboratory-reared Anopheles gambiae sensu stricto. Mosquito survival was assessed daily for 28 days post-feeding.
RESULTS


Between July 20, 2015, and May 7, 2016, 69 of 141 patients participated in both direct skin and membrane feeding (placebo, n = 23; 300 mcg/kg/day, n = 24; 600 mcg/kg/day, n = 22). The 14-day post-feeding mortality for mosquitoes fed 7 days post-treatment on blood from pooled patients in both ivermectin arms was similar with direct skin feeding (mosquitoes observed, n = 2941) versus membrane feeding (mosquitoes observed, n = 7380): cumulative mortality (risk ratio 0.99, 95% confidence interval [CI] 0.95-1.03, P = .69) and survival time (hazard ratio 0.96, 95% CI 0.91-1.02, P = .19). Results were consistent by sex, by body mass index, and across the range of ivermectin capillary concentrations studied (0.72-73.9 ng/mL).
CONCLUSIONS


Direct skin feeding and membrane feeding on day 7 resulted in similar mosquitocidal effects of ivermectin across a wide range of drug concentrations, suggesting that the mosquitocidal effects seen with membrane feeding accurately reflect those of natural biting. Membrane feeding, which is more patient friendly and ethically acceptable, can likely reliably be used to assess ivermectin's mosquitocidal efficacy.
CLINICAL TRIALS REGISTRATION


NCT02511353.",2019,Direct-skin-feeding on humans may lead to higher mosquito-mortality as ivermectin capillary-concentrations are higher.,"['69 of 141 patients participated in both direct-skin- and membrane-feeding (placebo n=23, 300mcg/kg/day', '141 adults with uncomplicated malaria in Kenya comparing 3-day', 'n=24, 600mcg/kg/day n=22']","['placebo', 'ivermectin', 'Ivermectin', 'ivermectin 0', 'direct-skin- and membrane-feeding', 'co-administered with dihydroartemisinin-piperaquine']","['survival-time', 'Mosquito survival', 'cumulative-mortality']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439418', 'cui_str': 'kg/day'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0026584', 'cui_str': 'Mosquitoes'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",141.0,0.245221,Direct-skin-feeding on humans may lead to higher mosquito-mortality as ivermectin capillary-concentrations are higher.,"[{'ForeName': 'Menno R', 'Initials': 'MR', 'LastName': 'Smit', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Eric O', 'Initials': 'EO', 'LastName': 'Ochomo', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu.'}, {'ForeName': 'Ghaith', 'Initials': 'G', 'LastName': 'Aljayyoussi', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Titus K', 'Initials': 'TK', 'LastName': 'Kwambai', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Bernard O', 'Initials': 'BO', 'LastName': ""Abong'o"", 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waterhouse', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Nabie M', 'Initials': 'NM', 'LastName': 'Bayoh', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Gimnig', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'Meghna R', 'Initials': 'MR', 'LastName': 'Desai', 'Affiliation': 'US Centers for Disease Control and Prevention, Center for Global Health, Division of Parasitic Diseases and Malaria, Atlanta, Georgia.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Phillips-Howard', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Simon K', 'Initials': 'SK', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Ward', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Liverpool School of Tropical Medicine, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy1063']
940,23589771,School-based health center intervention improves body mass index in overweight and obese adolescents.,"Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION) was undertaken to determine feasibility of a school-based health center (SBHC) weight management program. Two urban New Mexico SBHCs were randomized to deliver ACTION or standard care. ACTION consisted of eight visits using motivational interviewing to improve eating and physical activity behavior. An educational nutrition and physical activity DVD for students and a clinician toolkit were created for use as menu of options. Standard care consisted of one visit with the SBHC provider who prescribed recommendations for healthy weight. Sixty nondiabetic overweight/obese adolescents were enrolled. Measures included BMI percentile, waist circumference, insulin resistance by homeostasis model assessment (HOMA-IR), blood pressure, triglycerides, and HDL-C levels. Pre- to postchanges for participants were compared between groups. Fifty-one students (mean age 15 years, 62% female, 75% Hispanic) completed pre- and postmeasures. ACTION students (n = 28) had improvements in BMI percentile (P = 0.04) and waist circumference (P = 0.04) as compared with students receiving standard care (n = 23). No differences were found between the two groups in blood pressure, HOMA-IR, triglycerides, and HDL-C. The ACTION SBHC weight management program was feasible and demonstrated improved outcomes in BMI percentile and waist circumference.",2013,"No differences were found between the two groups in blood pressure, HOMA-IR, triglycerides, and HDL-C.","['students (n = 28', 'overweight and obese adolescents', 'Fifty-one students (mean age 15 years, 62% female, 75% Hispanic) completed pre- and postmeasures', 'Sixty nondiabetic overweight/obese adolescents', 'Two urban New Mexico SBHCs']","['school-based health center (SBHC) weight management program', 'Pre', 'motivational interviewing', 'School-based health center intervention']","['eating and physical activity behavior', 'BMI percentile, waist circumference, insulin resistance by homeostasis model assessment (HOMA-IR), blood pressure, triglycerides, and HDL-C levels', 'blood pressure, HOMA-IR, triglycerides, and HDL-C', 'waist circumference', 'BMI percentile', 'BMI percentile and waist circumference', 'body mass index']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0121521,"No differences were found between the two groups in blood pressure, HOMA-IR, triglycerides, and HDL-C.","[{'ForeName': 'Alberta S', 'Initials': 'AS', 'LastName': 'Kong', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM 87131-0001, USA. akong@salud.unm.edu'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Sussman', 'Affiliation': ''}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Yahne', 'Affiliation': ''}, {'ForeName': 'Betty J', 'Initials': 'BJ', 'LastName': 'Skipper', 'Affiliation': ''}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Burge', 'Affiliation': ''}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': ''}]",Journal of obesity,['10.1155/2013/575016']
941,23755093,The stroke oxygen pilot study: a randomized controlled trial of the effects of routine oxygen supplementation early after acute stroke--effect on key outcomes at six months.,"INTRODUCTION


Post-stroke hypoxia is common, and may adversely affect outcome. We have recently shown that oxygen supplementation may improve early neurological recovery. Here, we report the six-month outcomes of this pilot study.
METHODS


Patients with a clinical diagnosis of acute stroke were randomized within 24 h of admission to oxygen supplementation at 2 or 3 L/min for 72 h or to control treatment (room air). Outcomes (see below) were assessed by postal questionnaire at 6 months. Analysis was by intention-to-treat, and statistical significance was set at p ≤ 0.05.
RESULTS


Out of 301 patients randomized two refused/withdrew consent and 289 (148 in the oxygen and 141 in the control group) were included in the analysis: males 44%, 51%; mean (SD) age 73 (12), 71 (12); median (IQR) National Institutes of Health Stroke Scale score 6 (3, 10), 5 (3, 10) for the two groups respectively. At six months 22 (15%) patients in the oxygen group and 20 (14%) in the control group had died; mean survival in both groups was 162 days (p = 0.99). Median (IQR) scores for the primary outcome, the modified Rankin Scale, were 3 (1, 5) and 3 (1, 4) for the oxygen and control groups respectively. The covariate-adjusted odds ratio was 1.04 (95% CI 0.67, 1.60), indicating that the odds of a lower (i.e. better) score were non-significantly higher in the oxygen group (p = 0.86). The mean differences in the ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol) were also non-significant.
CONCLUSIONS


None of the key outcomes differed at 6 months between the groups. Although not statistically significant and generally of small magnitude, the effects were predominantly in favour of the oxygen group; a larger trial, powered to show differences in longer-term functional outcomes, is now on-going.
TRIAL REGISTRATION


Controlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41.",2014,"The mean differences in the ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol) were also non-significant.
CONCLUSIONS


","['Patients with a clinical diagnosis of acute stroke', '301 patients randomized two refused/withdrew consent and 289 (148 in the oxygen and 141 in the control group) were included in the analysis: males 44%, 51']","['routine oxygen supplementation', 'oxygen supplementation', 'admission to oxygen supplementation at 2 or 3 L/min for 72 h or to control treatment (room air']","['median (IQR) National Institutes of Health Stroke Scale score', 'ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol', 'died; mean survival', 'Median (IQR) scores', 'modified Rankin Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",301.0,0.245085,"The mean differences in the ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol) were also non-significant.
CONCLUSIONS


","[{'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Ali', 'Affiliation': 'Academic Department of Geriatrics, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Warusevitane', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lally', 'Affiliation': ''}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Sim', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sills', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pountain', 'Affiliation': ''}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Nevatte', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Allen', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Roffe', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0059274']
942,23720785,PTSD symptom reduction with mindfulness-based stretching and deep breathing exercise: randomized controlled clinical trial of efficacy.,"CONTEXT


Abnormal cortisol levels are a key pathophysiological indicator of post-traumatic stress disorder (PTSD). Endogenous normalization of cortisol concentration through exercise may be associated with PTSD symptom reduction.
OBJECTIVE


The aim of the study was to determine whether mindfulness-based stretching and deep breathing exercise (MBX) normalizes cortisol levels and reduces PTSD symptom severity among individuals with subclinical features of PTSD.
DESIGN AND SETTING


A randomized controlled trial was conducted at the University of New Mexico Health Sciences Center.
PARTICIPANTS


Twenty-nine nurses (28 female) aged 45-66 years participated in the study.
INTERVENTION


Sixty-minute MBX sessions were conducted semiweekly for 8 weeks.
MAIN OUTCOME MEASURES


Serum cortisol was measured, and the PTSD Checklist-Civilian version (PCL-C) was performed at baseline and weeks 4, 8, and 16.
RESULTS


Twenty-nine participants completed the study procedures, 22 (79%) with PTSD symptoms (MBX, n = 11; control, n = 11), and 7 (21%) without PTSD (BASE group). Eight-week outcomes for the MBX group were superior to those for the control group (mean difference for PCL-C scores, -13.6; 95% confidence interval [CI], -25.6, -1.6; P = .01; mean difference for serum cortisol, 5.8; 95% CI, 0.83, 10.8; P = .01). No significant differences were identified between groups in any other items. The changes in the MBX group were maintained at the 16-week follow-up (P = .85 for PCL-C; P = .21 for cortisol). Our data show that improved PTSD scores were associated with normalization of cortisol levels (P < .05).
CONCLUSIONS


The results suggest that MBX appears to reduce the prevalence of PTSD-like symptoms in individuals exhibiting subclinical features of PTSD.",2013,"mean difference for serum cortisol, 5.8; 95% CI, 0.83, 10.8; P = .01).","['Twenty-nine participants completed the study procedures, 22 (79%) with PTSD symptoms (MBX, n = 11; control, n = 11), and 7 (21%) without PTSD (BASE group', 'individuals with subclinical features of PTSD', 'University of New Mexico Health Sciences Center', 'Twenty-nine nurses (28 female) aged 45-66 years participated in the study']","['MBX', 'mindfulness-based stretching and deep breathing exercise (MBX', 'mindfulness-based stretching and deep breathing exercise']","['PTSD symptom severity', 'prevalence of PTSD-like symptoms', 'Serum cortisol', 'PTSD scores', 'normalization of cortisol levels', 'PTSD Checklist-Civilian version (PCL-C', 'PTSD symptom reduction', 'Abnormal cortisol levels']","[{'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0027972', 'cui_str': 'New Mexico'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises (regime/therapy)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0860768', 'cui_str': 'Abnormal hydrocortisone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",29.0,0.0346868,"mean difference for serum cortisol, 5.8; 95% CI, 0.83, 10.8; P = .01).","[{'ForeName': 'Sang Hwan', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'National Institutes of Health, Clinical Center, Bethesda, Maryland 20892, USA. sanghk@gmail.com'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bevans', 'Affiliation': ''}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Kravitz', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mermier', 'Affiliation': ''}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': ''}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Burge', 'Affiliation': ''}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2012-3742']
943,23040523,"Serum insulin-like factor 3 is highly correlated with intratesticular testosterone in normal men with acute, experimental gonadotropin deficiency stimulated with low-dose human chorionic gonadotropin: a randomized, controlled trial.","OBJECTIVE


To study the potential role for using serum biomarkers, including insulin-like factor 3 (INSL3), 17α-hydroxyprogesterone, antimüllerian hormone, and inhibin B, as correlates of intratesticular T (IT-T) concentrations in men.
DESIGN


Prospective, randomized, controlled trial.
SETTING


University-based medical center.
PATIENT(S)


Thirty-seven healthy men aged 18-50 years.
INTERVENTION(S)


All men received the GnRH antagonist acyline, plus very low doses of hCG (0 IU, 15 IU, 60 IU, or 125 IU) SC every other day or 7.5 g T gel daily (75 mg delivered). The IT-T concentrations obtained by percutaneous testicular aspiration with simultaneous serum protein and steroid concentrations were measured at baseline and after 10 days of treatment.
MAIN OUTCOME MEASURE(S)


Intratesticular and serum hormone and gonadotropin concentrations.
RESULT(S)


After 10 days of gonadotropin suppression, serum INSL3 decreased by more than 90% and correlated highly with IT-T concentrations. In contrast, serum inhibin B, antimüllerian hormone, and 17α-hydroxyprogesterone did not correlate with IT-T. Serum INSL3 increased with the dose of hCG administered and returned to baseline after treatment.
CONCLUSION(S)


Serum INSL3 correlates highly with IT-T and serum T concentrations during acute gonadotropin suppression in men. Human chorionic gonadotropin stimulates dose-dependent increases in INSL3 and IT-T in healthy men and might be a useful biomarker of IT-T concentration in some clinical settings.
CLINICAL TRIAL REGISTRATION NUMBER


NCT# 00839319.",2013,"Human chorionic gonadotropin stimulates dose-dependent increases in INSL3 and IT-T in healthy men and might be a useful biomarker of IT-T concentration in some clinical settings.
","['University-based medical center', 'normal men with acute, experimental gonadotropin deficiency stimulated with low-dose human chorionic gonadotropin', 'Thirty-seven healthy men aged 18-50 years', 'men', 'healthy men']","['GnRH antagonist acyline, plus very low doses of hCG', 'Human chorionic gonadotropin', 'hCG']","['serum protein and steroid concentrations', 'Intratesticular and serum hormone and gonadotropin concentrations', 'gonadotropin suppression, serum INSL3', 'insulin-like factor 3 (INSL3), 17α-hydroxyprogesterone, antimüllerian hormone, and inhibin B, as correlates of intratesticular T (IT-T) concentrations', 'serum inhibin B, antimüllerian hormone, and 17α-hydroxyprogesterone did not correlate with IT-T. Serum INSL3', 'Serum INSL3 correlates highly with IT-T and serum T concentrations']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4552011', 'cui_str': 'Gonadotropin deficiency'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0668202', 'cui_str': 'D-alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-4-(acetylamino)-L-phenylalanyl-4-(acetylamino)-D-phenylalanyl-L-leucyl-N6-(1-methylethyl)-L-lysyl-L-prolyl-'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}]","[{'cui': 'C0036825', 'cui_str': 'Serum Proteins'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0971174', 'cui_str': 'inhibin B'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",37.0,0.0582671,"Human chorionic gonadotropin stimulates dose-dependent increases in INSL3 and IT-T in healthy men and might be a useful biomarker of IT-T concentration in some clinical settings.
","[{'ForeName': 'Mara Y', 'Initials': 'MY', 'LastName': 'Roth', 'Affiliation': 'Center for Research in Reproduction and Contraception, Department of Medicine, University of Washington, Seattle, Washington. Electronic address: mylang@u.washington.edu.'}, {'ForeName': 'Kat', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Bay', 'Affiliation': 'University Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Amory', 'Affiliation': 'Center for Research in Reproduction and Contraception, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Anawalt', 'Affiliation': 'Center for Research in Reproduction and Contraception, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Alvin M', 'Initials': 'AM', 'LastName': 'Matsumoto', 'Affiliation': 'Center for Research in Reproduction and Contraception, Department of Medicine, University of Washington, Seattle, Washington; Geriatric Research, Education and Clinical Center, Veterans Affairs Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Marck', 'Affiliation': 'Geriatric Research, Education and Clinical Center, Veterans Affairs Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Bremner', 'Affiliation': 'Center for Research in Reproduction and Contraception, Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Page', 'Affiliation': 'Center for Research in Reproduction and Contraception, Department of Medicine, University of Washington, Seattle, Washington.'}]",Fertility and sterility,['10.1016/j.fertnstert.2012.09.009']
944,31855907,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise-Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2020,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada', 'Twenty race finishers with mild to moderately symptomatic EAH']","['Oral Hypertonic Saline', 'sealed envelopes, containing the word either ""oral"" or ""IV', 'HTS', 'oral HTS', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
945,32421411,"Re: Effect of Tadalafil 5 mg on Post-Micturition Dribble in Men with Lower Urinary Tract Symptoms: A Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial.",,2020,,['Men with Lower Urinary Tract Symptoms'],"['Tadalafil', 'Placebo']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.61342,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001118.04']
946,32130359,Azithromycin administered for acute bronchiolitis may have a protective effect on subsequent wheezing.,"OBJECTIVE


A significant proportion of the infants developed recurrent wheezing after an acute bronchiolitis (AB) event. Recent studies have demonstrated protection for recurrent wheeze and lower respiratory morbidity in infants treated with azithromycin during an acute respiratory wheezing. The aim of the present study was to test the hypothesis that administration of azithromycin during an AB event reduces subsequent wheezing and hospital re-admissions.
METHODS


This is a secondary analysis of a randomized, double-blinded, placebo-controlled trial, including unpublished data of wheezing and hospitalizations during the initial 6 months following admission for acute viral bronchiolitis. The study was performed in a tertiary University hospital. Infants (<12 months of age) hospitalized with AB were randomized to receive either azithromycin or placebo, administered orally, for 7 days. Families were contacted by telephone at 3 and 6 months after the initial acute event and answered to a standardized questionnaire in order to identify recurrent wheezing and hospital readmissions.
RESULTS


One hundred and four patients were included (Azithromycin group, n= 50; placebo group, n=54). Considering the total of patients contacted 3 months after hospitalization (n=70), the recurrence rate of wheezing in the azithromycin group was significantly lower than in the placebo group (RR = 0.48; CI = 0.24-0.98; p = 0.038).
CONCLUSION


Azithromycin significantly reduces the risk of subsequent wheezing between 0 and 3 months after hospital admission due to acute bronchiolitis irrespective of the presence of respiratory syncytial virus.",2020,Recent studies have demonstrated protection for recurrent wheeze and lower respiratory morbidity in infants treated with azithromycin during an acute respiratory wheezing.,"['acute viral bronchiolitis', 'tertiary University hospital', 'Infants (<12 months of age) hospitalized with AB', 'One hundred and four patients were included (Azithromycin group, n= 50; placebo group, n=54']","['placebo', 'azithromycin or placebo', 'azithromycin', 'Azithromycin']","['respiratory morbidity', 'risk of subsequent wheezing', 'recurrence rate of wheezing']","[{'cui': 'C0339941', 'cui_str': 'Acute viral bronchiolitis (disorder)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",104.0,0.517826,Recent studies have demonstrated protection for recurrent wheeze and lower respiratory morbidity in infants treated with azithromycin during an acute respiratory wheezing.,"[{'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Luisi', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Clarissa Aires', 'Initials': 'CA', 'LastName': 'Roza', 'Affiliation': 'Universidade de Santa Cruz do Sul, Santa Cruz do Sul (RS) Brasil.'}, {'ForeName': ""Victória d'Azevedo"", 'Initials': 'VD', 'LastName': 'Silveira', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Camila Correia', 'Initials': 'CC', 'LastName': 'Machado', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Katiana Murieli da', 'Initials': 'KMD', 'LastName': 'Rosa', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Paulo Márcio', 'Initials': 'PM', 'LastName': 'Pitrez', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Marcus Herbert', 'Initials': 'MH', 'LastName': 'Jones', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Renato Tetelbom', 'Initials': 'RT', 'LastName': 'Stein', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Lidiane Alves de Azeredo', 'Initials': 'LAA', 'LastName': 'Leitão', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Talitha', 'Initials': 'T', 'LastName': 'Comaru', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Magáli', 'Initials': 'M', 'LastName': 'Mocellin', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}, {'ForeName': 'Leonardo Araújo', 'Initials': 'LA', 'LastName': 'Pinto', 'Affiliation': 'Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre (RS) Brasil.'}]",Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia,['10.36416/1806-3756/e20180376']
947,31855906,"Efficacy of Intra-Articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2020,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['100 patients', 'Knee Osteoarthritis']","['PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone', 'Hyaluronic acid (HA', 'HA [PNs associated with HA (PNHA']","['knee function and pain', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function', 'adverse events', 'Knee Society Score total score and pain item']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
948,32423584,"Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial.","BACKGROUND


No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.
METHODS


We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2-10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656.
FINDINGS


Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87-1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95-2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.
INTERPRETATION


In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
FUNDING


Chinese Academy of Medical Sciences Emergency Project of COVID-19, National Key Research and Development Program of China, the Beijing Science and Technology Project.",2020,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"['Between Feb 6, 2020, and March 12, 2020, 237 patients', 'Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia', 'adults with severe COVID-19', 'patients with severe coronavirus disease 2019 (COVID-19', 'ten hospitals in Hubei, China']","['lopinavir-ritonavir, interferons, and corticosteroids', 'intravenous remdesivir', 'placebo']","['time to clinical improvement', 'six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first', 'Adverse events', 'intention-to-treat (ITT) population and safety analysis', 'adverse events']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",237.0,0.583704,Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23,"[{'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Guanhua', 'Initials': 'G', 'LastName': 'Du', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ronghui', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shouzhi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhenshun', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiaofa', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Guangwei', 'Initials': 'G', 'LastName': 'Luo', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'Jin Yin-tan Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Chengqing', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Mei', 'Affiliation': 'Wuhan Lung Hospital, Wuhan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Union Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianzhi', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Wuhan Third Hospital, Wuhan, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Wuhan Fourth Hospital, Wuhan, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'The Central Hospital of Wuhan, Wuhan, China.'}, {'ForeName': 'Aili', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Wuhan First Hospital, Wuhan, China.'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Tsinghua University School of Medicine, Beijing, China.'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Lianjun', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Tigermed Consulting, Hangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Teddy Clinical Research Laboratory, Shanghai, China.'}, {'ForeName': 'Yushen', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Hangzhou DI'AN Medical Laboratory, Hangzhou, China.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Lancaster University, Lancaster, UK; University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'International Severe Acute Respiratory and Emerging Infection Consortium, University of Oxford, Oxford, UK.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Respiratory Medicine, Capital Medical University, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China. Electronic address: caobin_ben@163.com.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijiing, China; Peking Union Medical College, Beijing, China. Electronic address: wangchen@pumc.edu.cn.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31022-9']
949,31145798,Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial.,"AIMS


The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG.
METHODS AND RESULTS


We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53).
CONCLUSION


In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated.
CLINICALTRIALS.GOV IDENTIFIER


NCT01755520.",2019,"All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group.","['patients undergoing coronary artery bypass grafting (CABG', 'patients after coronary artery bypass grafting', '3850 planned patients']","['aspirin', 'ticagrelor', 'CABG to either ticagrelor 90\u2009mg twice daily or 100\u2009mg aspirin', 'ticagrelor and aspirin', 'ticagrelor vs. aspirin']","['composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG', 'Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings', 'cardiovascular death', 'major cardiovascular events or major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",3850.0,0.279313,"All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group.","[{'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Boening', 'Affiliation': 'Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Ludwigstraße 23, Gießen, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'von Scheidt', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Lanig', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Gusmini', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'de Waha', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Kuna', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fach', 'Affiliation': 'Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Grothusen', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Oberhoffer', 'Affiliation': 'Department of Cardiac Surgery, Asklepios Klinik St. Georg, Lohmühlenstraße 5, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Knosalla', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walther', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Benekestraße 2-8, Bad Nauheim, Germany.'}, {'ForeName': 'Bernhard C', 'Initials': 'BC', 'LastName': 'Danner', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Medical Center, Robert-Koch-Straße 40, Göttingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Misfeld', 'Affiliation': 'University Department of Cardiac Surgery, Leipzig Heart Center, Strümpellstraße 39, Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Klinikum Ludwigshafen and Institut für Herzinfarktforschung Ludwigshafen, Bremserstraße 79, Ludwigshafen, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Wimmer-Greinecker', 'Affiliation': 'Department for Cardiothoracic Surgery, Heart and Vessel Center Bad Bevensen, Römstedter Straße 25, Bad Bevensen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Siepe', 'Affiliation': 'Department of Cardiovascular Surgery, Heart Centre Freiburg University, University of Freiburg, Hugstetter Straße 55, Freiburg, Germany.'}, {'ForeName': 'Herko', 'Initials': 'H', 'LastName': 'Grubitzsch', 'Affiliation': 'Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, Charitéplatz 1, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Joost', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, Medical Clinic II, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, Lübeck, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schaefer', 'Affiliation': 'Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Lenard', 'Initials': 'L', 'LastName': 'Conradi', 'Affiliation': 'Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Justus-Liebig University Gießen, Kerckhoff Campus, Ludwigstraße 23, Gießen, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Radke', 'Affiliation': 'Department of Internal Medicine-Cardiology, Schön Klinik Neustadt SE & Co. KG, Am Kiebitzberg 10, Neustadt, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Schulz', 'Affiliation': 'Institute of Physiology, Justus-Liebig University Gießen, Aulweg 129, Gießen, Germany.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Laufer', 'Affiliation': 'Division of Cardiac Surgery, Medical University Vienna, Spitalgasse 23, Wien, Austria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grieshaber', 'Affiliation': 'Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Ludwigstraße 23, Gießen, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Pader', 'Affiliation': 'Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Attmann', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Arnold-Heller-Straße 3, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schmoeckel', 'Affiliation': 'Department of Cardiac Surgery, Asklepios Klinik St. Georg, Lohmühlenstraße 5, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Ziegelhöffer', 'Affiliation': 'Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Benekestraße 2-8, Bad Nauheim, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hambrecht', 'Affiliation': 'Department of Cardiology and Angiology, Klinikum Links der Weser, Senator-Weßling-Straße 1, Bremen, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, Munich, Germany.'}, {'ForeName': 'Sigrid E', 'Initials': 'SE', 'LastName': 'Sandner', 'Affiliation': 'Division of Cardiac Surgery, Medical University Vienna, Spitalgasse 23, Wien, Austria.'}]",European heart journal,['10.1093/eurheartj/ehz185']
950,31155673,Impact of preoperative fractional flow reserve on arterial bypass graft anastomotic function: the IMPAG trial.,"AIMS


Visual estimation is the most commonly used method to evaluate the degree of coronary artery stenosis prior to coronary artery bypass grafting. In interventional cardiology, the use of fractional flow reserve (FFR) to guide revascularization decisions has become routine. We investigated whether the preoperative FFR measurement of coronary lesions is associated with anastomosis function 6 months after surgical revascularization using a multiarterial grafting strategy.
METHODS AND RESULTS


In this prospective double-blind study, 67 patients were enrolled from two institutions in Europe and Canada. From these patients, 199 coronary lesions were assessed visually and with FFR at the time of the preoperative angiogram. All patients received coronary revascularization using multiple arterial grafts. A post-operative 6-month angiogram was performed to assess anastomosis functionality using a described angiographic method. The primary outcome was the association between preoperative FFR values and anastomosis function 6 months after surgery. Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P  <  0.001). An FFR value of ≤0.78 was associated with an anastomotic occlusion rate of 3%.
CONCLUSION


We found a significant association between the preoperative FFR measurement of the target vessel and the anastomotic functionality at 6 months, with a cut-off of 0.78. Integration of FFR measurement into the preoperative diagnostic workup before multiarterial coronary surgical revascularization leads to improved anastomotic graft function.
CLINICAL TRIALS. GOV IDENTIFIER


NCT02527044.",2019,Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P  <  0.001).,['67 patients were enrolled from two institutions in Europe and Canada'],['coronary revascularization using multiple arterial grafts'],"['arterial bypass graft anastomotic function', 'anastomotic occlusion rate', '6-months anastomotic function', 'Preoperative FFR', 'preoperative FFR values and anastomosis function', 'preoperative FFR measurement of the target vessel and the anastomotic functionality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0450140', 'cui_str': 'Arterial graft (morphologic abnormality)'}]","[{'cui': 'C0189695', 'cui_str': 'Arterial bypass graft'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}]",67.0,0.0303736,Preoperative FFR was significantly associated with 6-months anastomotic function for all conduits and for all targets (P  <  0.001).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glineur', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Juan B', 'Initials': 'JB', 'LastName': 'Grau', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Etienne', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Benedetto', 'Affiliation': 'Department of Cardiothoracic Surgery, New York Presbyterian-Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Jacqueline H', 'Initials': 'JH', 'LastName': 'Fortier', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Spiridon', 'Initials': 'S', 'LastName': 'Papadatos', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Laruelle', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Pieters', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'El Khoury', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Blouard', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Timmermans', 'Affiliation': 'Division of Cardiology, Cliniques St Luc Bouge, Bouge, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Aun-Yeong', 'Initials': 'AY', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Rubens', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa Heart Institute, 40 Ruskin St, Ottawa, Ontario K1Y 4W7, Canada.'}, {'ForeName': 'Mario Fl', 'Initials': 'MF', 'LastName': 'Gaudino', 'Affiliation': 'Department of Cardiothoracic Surgery, New York Presbyterian-Weill Cornell Medicine, New York, NY, USA.'}]",European heart journal,['10.1093/eurheartj/ehz329']
951,32423239,Post hoc  Responder and Remission Analyses from Two Studies of SHP465 Mixed Amphetamine Salts Extended-Release Among Adults with Attention-Deficit/Hyperactivity Disorder.,"Objectives:  In two studies of adult attention-deficit/hyperactivity disorder (ADHD), SHP465 mixed amphetamine salts (MAS) extended-release significantly reduced ADHD-Rating Scale, 4th Edition total score (ADHD-RS-IV-TS) versus placebo (PBO). This report describes  post hoc  analyses of SHP465 MAS treatment response and remission rates from those studies.  Methods:  Adults with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision-defined ADHD were randomized to SHP465 MAS (12.5-75 mg) or PBO in a 7-week dose-optimization study and to SHP465 MAS (25, 50, or 75 mg) or PBO in a 6-week fixed-dose study. Response was examined using three definitions (definition 1: ≥30% ADHD-RS-IV-TS reduction + Clinical Global Impressions-Improvement [CGI-I] rating of 1 or 2; definition 2: ≥50% ADHD-RS-IV-TS reduction + CGI-I rating of 1 or 2; definition 3: ADHD-RS-IV-TS ≤18). Remission was defined as ADHD-RS-IV-TS ≤12. The Kaplan-Meier analyses assessed time to response or remission.  Results:  The intent-to-treat populations included 136 SHP465 MAS and 132 PBO participants in the dose-optimization study and 302 SHP465 MAS and 103 PBO participants in the fixed-dose study. Percentages of participants meeting response criteria (SHP465 MAS vs. PBO) at the final treatment week in the dose-optimization and fixed-dose studies, respectively, were 66.0% versus 31.6% and 72.7% versus 28.3% (definition 1); 47.9% versus 27.6% and 60.6% versus 16.7% (definition 2); and 54.3% versus 30.3% and 52.6% versus 18.3% (definition 3). The remission criterion (SHP465 MAS vs. PBO) at the final treatment week was met by 37.2% versus 19.7% of participants in the dose-optimization study and 39.7% versus 10.0% of participants in the fixed-dose study. Times to response and remission favored SHP465 MAS over PBO in both studies (all nominal log-rank  p  < 0.0001).  Conclusion:  These  post hoc  analyses indicate that SHP465 MAS was associated with greater response and remission rates than PBO in adults with ADHD, with times to response and remission also nominally favoring SHP465 MAS.",2020,Times to response and remission favored SHP465 MAS over PBO in both studies (all nominal log-rank  p  < 0.0001).  ,"['Adults with Attention-Deficit/Hyperactivity Disorder', '132 PBO participants in the dose-optimization study and 302 SHP465 MAS and 103 PBO participants in the fixed-dose study', 'Adults with Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision-defined ADHD']","['SHP465 MAS', 'PBO', 'SHP465 Mixed Amphetamine Salts', 'SHP465 mixed amphetamine salts (MAS']","['time to response or remission', 'remission rates', 'remission criterion (SHP465 MAS vs. PBO', 'Remission', 'ADHD-Rating Scale, 4th Edition total score', 'response and remission rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.030036,Times to response and remission favored SHP465 MAS over PBO in both studies (all nominal log-rank  p  < 0.0001).  ,"[{'ForeName': 'Lenard A', 'Initials': 'LA', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and NYU Langone Medical Center, New York, New York, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Global Clinical Development, Shire, a member of the Takeda group of companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Biostatistics, Shire, a member of the Takeda group of companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Sarkis', 'Affiliation': 'Sarkis Family Psychiatry, Gainesville, Florida, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0012']
952,31860107,Effect of Teaching Bayesian Methods Using Learning by Concept vs Learning by Example on Medical Students' Ability to Estimate Probability of a Diagnosis: A Randomized Clinical Trial.,"Importance


Clinicians use probability estimates to make a diagnosis. Teaching students to make more accurate probability estimates could improve the diagnostic process and, ultimately, the quality of medical care.
Objective


To test whether novice clinicians can be taught to make more accurate bayesian revisions of diagnostic probabilities using teaching methods that apply either explicit conceptual instruction or repeated examples.
Design, Setting, and Participants


A randomized clinical trial of 2 methods for teaching bayesian updating and diagnostic reasoning was performed. A web-based platform was used for consent, randomization, intervention, and testing of the effect of the intervention. Participants included 61 medical students at McMaster University and Eastern Virginia Medical School recruited from May 1 to September 30, 2018.
Interventions


Students were randomized to (1) receive explicit conceptual instruction regarding diagnostic testing and bayesian revision (concept group), (2) exposure to repeated examples of cases with feedback regarding posttest probability (experience group), or (3) a control condition with no conceptual instruction or repeated examples.
Main Outcomes and Measures


Students in all 3 groups were tested on their ability to update the probability of a diagnosis based on either negative or positive test results. Their probability revisions were compared with posttest probability revisions that were calculated using the Bayes rule and known test sensitivity and specificity.
Results


Of the 61 participants, 22 were assigned to the concept group, 20 to the experience group, and 19 to the control group. Approximate age was 25 years. Two participants were first-year; 37, second-year; 12, third-year; and 10, fourth-year students. Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001). Although statistically significant, the differences between groups were relatively modest, and students in all groups performed better than expected, based on prior reports in the literature.
Conclusions and Relevance


The study showed a modest advantage for students who received theoretical instruction on bayesian concepts. All participants' probability estimates were, on average, close to the bayesian calculation. These findings have implications for how to teach diagnostic reasoning to novice clinicians.
Trial Registration


ClinicalTrials.gov identifier: NCT04130607.",2019,"Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001).","['61 participants', 'Participants included 61 medical students at McMaster University and Eastern Virginia Medical School recruited from May 1 to September 30, 2018', 'Two participants were first-year; 37, second-year; 12, third-year; and 10, fourth-year students']","['explicit conceptual instruction regarding diagnostic testing and bayesian revision (concept group), (2) exposure to repeated examples of cases with feedback regarding posttest probability (experience group), or (3) a control condition with no conceptual instruction or repeated examples', 'Teaching Bayesian Methods Using Learning by Concept vs Learning by Example']","['Mean (SE) probability estimates', 'probability of a diagnosis based on either negative or positive test results', 'calculated bayesian probability']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242198', 'cui_str': 'Bayesian Method'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",61.0,0.049877,"Mean (SE) probability estimates of students in the concept group were statistically significantly closer to calculated bayesian probability than the other 2 groups (concept, 0.4%; [0.7%]; experience, 3.5% [0.7%]; control, 4.3% [0.7%]; P < .001).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Brush', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Eastern Virginia Medical School, Sentara Healthcare, Norfolk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sherbino', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'Taylor-Fishwick', 'Affiliation': 'Cardiology Division, Department of Internal Medicine, Eastern Virginia Medical School, Sentara Healthcare, Norfolk.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Norman', 'Affiliation': 'McMaster Education Research, Innovation and Theory Program, McMaster University, Hamilton, Ontario, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.18023']
953,22406907,Comparison of the effects of weight loss from a high-protein versus standard-protein energy-restricted diet on strength and aerobic capacity in overweight and obese men.,"PURPOSE


To compare the effects of two low-fat, hypoenergetic diets differing in carbohydrate-to-protein ratio, on strength and aerobic capacity measures in overweight and obese men.
METHODS


In a parallel design, 56 men (age, 45.5 ± 8.7 years; BMI, 33.6 ± 3.9 kg/m(2)) were randomly assigned to a low-fat, energy-restricted diet (7,000 kJ/day) with either high protein (HP: protein/carbohydrate/fat % energy, 35:40:25) or standard protein (SP, 17:58:25). Body weight, body composition, muscle strength and aerobic capacity were assessed at baseline and after 12 weeks.
RESULTS


Forty-two participants completed the study (HP, n = 21; SP, n = 21). Both groups experienced similar reductions in body weight (HP, -10.7 ± 5.3 kg [-9.8%]; SP, -8.7 ± 3.5 kg [-8.4%]) and fat-free mass (HP, -2.8 ± 3.6 kg; SP, -3.2 ± 2.7 kg; P < 0.001 time; P > 0.14 time × group interaction). There was a trend for a greater reduction in fat mass in the HP diet group, (-7.7 ± 4.3 kg [-21.2%] vs. -5.4 ± 3.3 kg [-15.1%]; P < 0.001 time; P = 0.06 time × group interaction). Absolute peak oxygen uptake did not change in either group (P = 0.39 time; P = 0.50 time × group interaction). Overall, in both groups, relative peak oxygen uptake increased (2.9 ± 2.8 ml kg(-1) min(-1) [8.9%]), peak isometric knee extensor strength increased (14.1 ± 35.7 Nm [7.1%]) and peak handgrip strength decreased (-1.6 ± 4.1 kg [-3%]) (P ≤ 0.02 time for all), with no diet effect (P ≤ 0.23 time × group interaction).
CONCLUSION


In overweight and obese men, both a HP and SP diet reduced body weight and improved body composition with similar effects on strength and aerobic capacity.",2013,Absolute peak oxygen uptake did not change in either group (P = 0.39 time; P = 0.50 time × group interaction).,"['Forty-two participants completed the study (HP, n = 21; SP, n = 21', '56 men (age, 45.5 ± 8.7 years; BMI, 33.6 ± 3.9 kg/m(2', 'overweight and obese men']","['low-fat, hypoenergetic diets', 'weight loss from a high-protein versus standard-protein energy-restricted diet', 'low-fat, energy-restricted diet (7,000 kJ/day) with either high protein (HP: protein/carbohydrate/fat % energy, 35:40:25) or standard protein (SP, 17:58:25']","['Absolute peak oxygen uptake', 'peak handgrip strength', 'strength and aerobic capacity', 'Body weight, body composition, muscle strength and aerobic capacity', 'body weight', 'body weight and improved body composition', 'fat mass', 'strength and aerobic capacity measures', 'relative peak oxygen uptake', 'peak isometric knee extensor strength']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0456646', 'cui_str': 'kilojoules/day'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",42.0,0.0234764,Absolute peak oxygen uptake did not change in either group (P = 0.39 time; P = 0.50 time × group interaction).,"[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Wycherley', 'Affiliation': 'Division of Health Sciences, Sansom Institute for Health Research, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': ''}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': ''}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': ''}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-012-0338-0']
954,22453228,Hypnotherapy for treatment of overactive bladder: a randomized controlled trial pilot study.,"OBJECTIVES


: The objective of the study was to obtain pilot data comparing hypnotherapy and behavioral therapy (hypnotherapy) to behavioral therapy alone (behavioral therapy) in overactive bladder (OAB) treatment.
METHODS


: Women with OAB were randomized to hypnotherapy or behavioral therapy treatments. Patient Global Impression of Improvement (PGI-I), the OAB-q Short Form (OAB-q SF) questionnaire, and voiding diaries were recorded, and within- and between-group differences were compared.
RESULTS


: Twenty women enrolled in and completed the study. Both hypnotherapy and behavioral therapy groups improved their mean number of voids (P = 0.005, P = 0.01, respectively) and their OAB-q SF distress scores (P = 0.002, P = 0.03). The hypnotherapy group had significant improvement in quality-of-life scores (P < 0.001), whereas the behavioral group did not (P = 0.05). Between-group comparisons showed that the hypnotherapy group had superior PGI-I scores compared with the behavioral group (P < 0.009). The hypnotherapy group trended toward greater improvement in OAB-q quality-of-life scores compared with the behavioral therapy group (67% vs 42% improvement), although this did not reach statistical significance (P = 0.07). Number of voids and OAB-q SF distress scores improved in both groups with no difference between groups.
CONCLUSIONS


: Both groups improved with treatment. Hypnotherapy resulted in superior PGI-I scores compared with behavioral therapy. Voiding and OAB-q SF results trended toward greater improvement with hypnotherapy. As a pilot study, recruitment was underpowered to find statistical differences between groups' voids and OAB scores. These findings support the need for an expanded trial that could likely show hypnotherapy to be superior in OAB treatment.",2011,"Both hypnotherapy and behavioral therapy groups improved their mean number of voids (P = 0.005, P = 0.01, respectively) and their OAB-q SF distress scores (P = 0.002, P = 0.03).","['overactive bladder', 'Women with OAB', 'Twenty women enrolled in and completed the study', 'overactive bladder (OAB) treatment']","['hypnotherapy and behavioral therapy', 'hypnotherapy', 'hypnotherapy and behavioral therapy (hypnotherapy', 'Hypnotherapy', 'hypnotherapy or behavioral therapy treatments', 'behavioral therapy alone (behavioral therapy']","['quality-of-life scores', 'superior PGI-I scores', 'Patient Global Impression of Improvement (PGI-I), the OAB-q Short Form (OAB-q SF) questionnaire, and voiding diaries', 'Voiding and OAB-q', 'voids and OAB scores', 'mean number of voids', 'Number of voids and OAB-q SF distress scores', 'OAB-q SF distress scores', 'OAB-q quality-of-life scores']","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4706333', 'cui_str': 'Patient Global Impression of Improvement (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",20.0,0.0383847,"Both hypnotherapy and behavioral therapy groups improved their mean number of voids (P = 0.005, P = 0.01, respectively) and their OAB-q SF distress scores (P = 0.002, P = 0.03).","[{'ForeName': 'Yuko M', 'Initials': 'YM', 'LastName': 'Komesu', 'Affiliation': 'From the Departments of *Obstetrics and Gynecology, †Emergency Room Medicine, and ‡Radiology, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sapien', 'Affiliation': ''}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ''}, {'ForeName': 'Loren H', 'Initials': 'LH', 'LastName': 'Ketai', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0b013e31823a08d9']
955,31843251,Quality of life after pharmacomechanical catheter-directed thrombolysis for proximal deep venous thrombosis.,"BACKGROUND


After deep venous thrombosis (DVT), many patients have impaired quality of life (QOL). We aimed to assess whether pharmacomechanical catheter-directed thrombolysis (PCDT) improves short-term or long-term QOL in patients with proximal DVT and whether QOL is related to extent of DVT.
METHODS


The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) trial was an assessor-blinded randomized trial that compared PCDT with no PCDT in patients with DVT of the femoral, common femoral, or iliac veins. QOL was assessed at baseline and 1 month, 6 months, 12 months, 18 months, and 24 months using the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures. Change in QOL scores from baseline to assessment time were compared in the PCDT and no PCDT treatment groups overall and in the iliofemoral DVT and femoral-popliteal DVT subgroups.
RESULTS


Of 692 ATTRACT patients, 691 were analyzed (mean age, 53 years; 62% male; 57% iliofemoral DVT). VEINES-QOL change scores were greater (ie, better) in PCDT vs no PCDT from baseline to 1 month (difference, 5.7; P = .0006) and from baseline to 6 months (5.1; P = .0029) but not for other intervals. SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 2.4; P = .01) but not for other intervals. Among iliofemoral DVT patients, VEINES-QOL change scores from baseline to all assessments were greater in the PCDT vs no PCDT group; this was statistically significant in the intention-to-treat analysis at 1 month (difference, 10.0; P < .0001) and 6 months (8.8; P < .0001) and in the per-protocol analysis at 18 months (difference, 5.8; P = .0086) and 24 months (difference, 6.6; P = .0067). SF-36 PCS change scores were greater in PCDT vs no PCDT from baseline to 1 month (difference, 3.2; P = .0010) but not for other intervals. In contrast, in femoral-popliteal DVT patients, change scores from baseline to all assessments were similar in the PCDT and no PCDT groups.
CONCLUSIONS


Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later. In patients with iliofemoral DVT, PCDT led to greater improvement in disease-specific QOL during 24 months.",2020,"Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later.","['patients with DVT of the femoral, common femoral, or iliac veins', 'proximal deep venous thrombosis', 'Of 692 ATTRACT patients, 691 were analyzed (mean age', '53\xa0years; 62% male; 57% iliofemoral DVT', 'patients with proximal DVT and whether QOL']","['PCDT with no PCDT', 'pharmacomechanical catheter-directed thrombolysis', 'pharmacomechanical catheter-directed thrombolysis (PCDT', 'PCDT']","['QOL scores', 'disease-specific QOL', 'Quality of life', 'VEINES-QOL change scores', 'Quality of Life/Symptoms (VEINES-QOL/Sym) disease-specific QOL measure and the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary general QOL measures', 'SF-36 PCS change scores', 'QOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0020888', 'cui_str': 'Iliac Vein'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",691.0,0.105402,"Among patients with proximal DVT, PCDT leads to greater improvement in disease-specific QOL than no PCDT at 1 month and 6 months but not later.","[{'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. Electronic address: susan.kahn@mcgill.ca.'}, {'ForeName': 'Jim A', 'Initials': 'JA', 'LastName': 'Julian', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada; Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chu-Shu', 'Initials': 'CS', 'LastName': 'Gu', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""Department of Medicine, University of Missouri-Kansas City, Kansas City, Mo; St. Luke's Mid America Heart Institute, Kansas City, Mo.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Magnuson', 'Affiliation': ""St. Luke's Mid America Heart Institute, Kansas City, Mo.""}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Comerota', 'Affiliation': 'Inova Heart and Vascular Institute, Inova Alexandria Hospital, Alexandria, Va.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Mass; Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': 'Harvard Medical School, Boston, Mass; Newton-Wellesley Hospital, Newton, Mass.'}, {'ForeName': 'Mahmood K', 'Initials': 'MK', 'LastName': 'Razavi', 'Affiliation': ""St. Joseph's Hospital, Orange, Calif.""}, {'ForeName': 'Andrei L', 'Initials': 'AL', 'LastName': 'Kindzelski', 'Affiliation': 'Division of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Schneider', 'Affiliation': 'Vascular Surgery and Interventional Radiology Partners/VSIR, Northwestern Medicine, Chicago, Ill.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Maine Medical Center, Portland, Me.'}, {'ForeName': 'Rabih', 'Initials': 'R', 'LastName': 'Chaer', 'Affiliation': 'Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa.'}, {'ForeName': 'Akhilesh K', 'Initials': 'AK', 'LastName': 'Sista', 'Affiliation': 'Department of Radiology, New York University, New York, NY.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'McLafferty', 'Affiliation': 'Department of Surgery, Portland Veterans Administration, Portland, Me.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kaufman', 'Affiliation': 'Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health & Science University, Portland.'}, {'ForeName': 'Brandt C', 'Initials': 'BC', 'LastName': 'Wible', 'Affiliation': ""Department of Radiology, St. Luke's Hospital, Kansas City, Mo.""}, {'ForeName': 'Morey', 'Initials': 'M', 'LastName': 'Blinder', 'Affiliation': 'Department of Medicine, Washington University in St. Louis, St. Louis, Mo.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Vedantham', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, Mo.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2019.03.023']
956,31377776,Thromboembolic events around the time of cardioversion for atrial fibrillation in patients receiving antiplatelet treatment in the ACTIVE trials.,"AIMS


It is unknown whether cardioversion of atrial fibrillation causes thromboembolic events or is a risk marker. To assess causality, we examined the temporal pattern of thromboembolism in patients having cardioversion.
METHODS AND RESULTS


We studied patients randomized to aspirin or aspirin plus clopidogrel in the ACTIVE trials, comparing the thromboembolic rate in the peri-cardioversion period (30 days before until 30 days after) to the rate during follow-up, remote from cardioversion. Among 962 patients, the 30-day thromboembolic rate remote from cardioversion was 0.16%; while it was 0.73% in the peri-cardioversion period [hazard ratio (HR) 4.1, 95% confidence interval (CI) 2.1-7.9]. The 30-day thromboembolic rates in the periods immediately before and after cardioversion were 0.47% and 0.96%, respectively (HR 2.2, 95% CI 0.7-7.1). Heart failure (HF) hospitalization increased in the peri-cardioversion period (HR 11.5, 95% CI 6.8-19.4). Compared to baseline, the thromboembolic rate in the 30 days following cardioversion was increased both in patients who received oral anticoagulation or a transoesophageal echocardiogram prior to cardioversion (HR 7.9, 95% CI 2.8-22.4) and in those who did not (HR 4.8, 95% CI 1.6-14.9) (interaction P = 0.2); the risk was also increased with successful (HR 4.5; 95% CI 2.0-10.5) and unsuccessful (HR 10.2; 95% CI 2.3-44.9) cardioversion.
CONCLUSIONS


Thromboembolic risk increased in the 30 days before cardioversion and persisted until 30 days post-cardioversion, in a pattern similar to HF hospitalization. These data suggest that the increased thromboembolic risk around the time of cardioversion may not be entirely causal, but confounded by the overall clinical deterioration of patients requiring cardioversion.",2019,"Compared to baseline, the thromboembolic rate in the 30 days following cardioversion was increased both in patients who received oral anticoagulation or a transoesophageal echocardiogram prior to cardioversion (HR 7.9, 95% CI 2.8-22.4) and in those who did not (HR 4.8, 95% CI 1.6-14.9) (interaction P = 0.2); the risk was also increased with successful (HR 4.5; 95% CI 2.0-10.5) and unsuccessful (HR 10.2; 95% CI 2.3-44.9) cardioversion.
","['patients having cardioversion', 'patients receiving antiplatelet treatment in the ACTIVE trials']",['aspirin or aspirin plus clopidogrel'],"['Thromboembolic events', 'thromboembolic risk', 'Heart failure (HF) hospitalization', 'thromboembolic rate', '30-day thromboembolic rates', '30-day thromboembolic rate remote from cardioversion', 'Thromboembolic risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}]",962.0,0.0807114,"Compared to baseline, the thromboembolic rate in the 30 days following cardioversion was increased both in patients who received oral anticoagulation or a transoesophageal echocardiogram prior to cardioversion (HR 7.9, 95% CI 2.8-22.4) and in those who did not (HR 4.8, 95% CI 1.6-14.9) (interaction P = 0.2); the risk was also increased with successful (HR 4.5; 95% CI 2.0-10.5) and unsuccessful (HR 10.2; 95% CI 2.3-44.9) cardioversion.
","[{'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'McIntyre', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Masiero', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Benz', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Conen', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Wong', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Beresh', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Healey', 'Affiliation': 'Population Health Research Institute, McMaster University, 30 Birge St. Room C3-121, Hamilton, Ontario, Canada.'}]",European heart journal,['10.1093/eurheartj/ehz521']
957,31843246,Elastic compression after ultrasound-guided foam sclerotherapy in overweight patients does not improve primary venous hemodynamics outcomes.,"OBJECTIVE


Lower extremity varicose veins have a high prevalence and can be associated with significant morbidity in their more advanced presentations; overweight patients tend to present with more severe clinical symptoms and conventional surgical treatment remains challenging. Although the advent of ultrasound-guided foam sclerotherapy (UGFS) increased the treatment options for these patients, the need for elastic compression after UGFS remains controversial.
METHODS


Overweight patients with lower extremity varicose veins secondary to great saphenous vein reflux were treated with UGFS and then randomized to use or no use of a 3-week treatment of elastic compression stockings. Follow-up was performed by clinical evaluation and duplex ultrasound examination. The primary outcome measure was the absence of venous reflux in the great saphenous vein.
RESULTS


One hundred thirty-five lower limbs were treated; 72 limbs were randomized to elastic compression and 63 limbs to the control group. There were no statistically significant differences in the number of procedures (P = .64) or the mean foam volume per procedure (P = .27) between groups. There was no difference in the reflux rate at either 3 weeks (26% vs 35%; P = .16) or 3 months (25% vs 21%; P = .85). Major complications were venous deep thrombosis (n = 2), neurologic event (n = 1), and ischemic ulceration (n = 1); the overall rate was 3% in both groups-2 of 62 in control patients and 2 of 69 in compression patients (P = .45). Venous diameter reduction was noted in both groups during treatment (P < .05) but with greater decrease in greater saphenous vein diameter in patients treated with compression.
CONCLUSIONS


Elastic compression stockings for 3 consecutive weeks after UGFS in overweight patients did not decrease great saphenous vein reflux, need for repeat procedures, or the volume of foam injected. However, UGFS was associated with a greater and uniform reduction in saphenous vein diameter at all times after the procedure.",2020,There was no difference in the reflux rate at either 3 weeks (26% vs 35%; P = .16) or 3 months (25% vs 21%; P = .85).,"['One hundred thirty-five lower limbs were treated; 72 limbs', 'overweight patients', 'Overweight patients with lower extremity varicose veins secondary to great saphenous vein reflux were treated with']","['Elastic compression after ultrasound-guided foam sclerotherapy', 'UGFS', 'elastic compression stockings', 'ultrasound-guided foam sclerotherapy (UGFS', 'elastic compression', 'Elastic compression stockings']","['saphenous vein diameter', 'reflux rate', 'Venous diameter reduction', 'number of procedures', 'absence of venous reflux in the great saphenous vein', 'neurologic event', 'ischemic ulceration', 'great saphenous vein reflux', 'overall rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0036435', 'cui_str': 'Sclerotherapy'}, {'cui': 'C0038348', 'cui_str': 'Compression Stockings'}]","[{'cui': 'C0036186', 'cui_str': 'Saphenous Vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C2363955', 'cui_str': 'Venous reflux'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C3887532', 'cui_str': 'Ulceration (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",135.0,0.0432575,There was no difference in the reflux rate at either 3 weeks (26% vs 35%; P = .16) or 3 months (25% vs 21%; P = .85).,"[{'ForeName': 'Cristiane Vilaça', 'Initials': 'CV', 'LastName': 'Campos Gomes', 'Affiliation': 'Department of Cardiovascular, Division of Vascular Surgery, University Hospital of Sergipe, Federal University of Sergipe, Aracaju, Brazil. Electronic address: cristianevilaca@gmail.com.'}, {'ForeName': 'Marco Antônio', 'Initials': 'MA', 'LastName': 'Prado Nunes', 'Affiliation': 'Department of Cardiovascular, Division of Vascular Surgery, University Hospital of Sergipe, Federal University of Sergipe, Aracaju, Brazil.'}, {'ForeName': 'Tulio Pinho', 'Initials': 'TP', 'LastName': 'Navarro', 'Affiliation': 'Department of Surgery, Vascular Surgery Unit, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Dardik', 'Affiliation': 'Department of Surgery, Division of Vascular Surgery, Yale University School of Medicine, New Haven, Conn.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2019.07.008']
958,31841599,"Nilotinib Effects on Safety, Tolerability, and Potential Biomarkers in Parkinson Disease: A Phase 2 Randomized Clinical Trial.","Importance


This study evaluated nilotinib safety and its effects on biomarkers as a potential disease-modifying drug in Parkinson disease.
Objectives


To assess nilotinib effects on safety and pharmacokinetics and measure the change in exploratory biomarkers in patients with moderately severe Parkinson disease.
Design, Setting, and Participants


This was a single-center, phase 2, randomized, double-blind, placebo-controlled trial with 300 patients approached in clinic; of these, 200 declined to participate, 100 were screened, 25 were excluded, and 75 were randomized 1:1:1 into placebo; nilotinib, 150-mg; or nilotinib, 300-mg groups. Recruitment started on May 17, 2017, and ended April 28, 2018, and follow-up ended August 10, 2019. Parkinson disease was confirmed according to the UK Brain Bank diagnostic criteria and symptoms were stabilized with use of optimal levodopa and/or dopamine agonists and other medications used in Parkinson disease.
Interventions


Nilotinib vs placebo, administered orally once daily for 12 months followed by a 3-month washout period.
Main Outcomes and Measures


It was hypothesized that nilotinib is safe and can be detected in the cerebrospinal fluid, where it alters exploratory biomarkers via inhibition of Abelson tyrosine kinase and potentially improves clinical outcomes.
Results


Of the 75 patients included in the study, 55 were men (73.3%); mean (SD) age was 68.4 (8.2) years. Doses of 150 or 300 mg of nilotinib were reasonably safe, although more serious adverse events were detected in the nilotinib (150 mg: 6 [24%]; 300 mg: 12 [48%]) vs placebo (4 [16%]) groups. The 150-mg nilotinib group showed an increase in cerebrospinal fluid levels of the dopamine metabolites homovanillic acid (159.80nM; 90% CI, 7.04-312.60nM; P = .04) and 3,4-dihydroxyphenylacetic acid (4.87nM; 90% CI, 1.51-8.23nM; P = .01), and the 300-mg nilotinib group showed an increase in 3,4-dihydroxyphenylacetic acid (7.52nM; 90% CI, 2.35-12.69nM; P = .01). The nilotinib 150-mg but not the nilotinib 300-mg group demonstrated a reduction of α-synuclein oligomers (-0.04 pg/mL; 90% CI, -0.08 to 0.01 pg/mL; P = .03). A significant reduction of hyperphosphorylated tau levels was seen in the nilotinib 150-mg (-10.04 pg/mL; 90% CI, -17.41 to -2.67 pg/mL; P = .01) and nilotinib 300-mg (-12.05 pg/mL; 90% CI, -19.21 to -4.90 pg/mL; P = .01) groups.
Conclusions and Relevance


In this study, nilotinib appeared to be reasonably safe and detectable in the cerebrospinal fluid. Exploratory biomarkers were altered in response to nilotinib. Taken together, these data will guide the development of a phase 3 study to investigate the effects of nilotinib therapy in patients with Parkinson disease.
Trial Registration


ClinicalTrials.gov identifier: NCT02954978.",2020,"The 150-mg nilotinib group showed an increase in cerebrospinal fluid levels of the dopamine metabolites homovanillic acid (159.80nM; 90% CI, 7.04-312.60nM; P = .04) and 3,4-dihydroxyphenylacetic acid (4.87nM; 90% CI, 1.51-8.23nM; P = .01), and the 300-mg nilotinib group showed an increase in 3,4-dihydroxyphenylacetic acid (7.52nM; 90% CI, 2.35-12.69nM; P = .01).","['75 patients included in the study, 55 were men (73.3', 'patients with Parkinson disease', 'mean (SD) age was 68.4 (8.2) years', 'Parkinson Disease', 'patients with moderately severe Parkinson disease', '300 patients approached in clinic; of these, 200 declined to participate, 100 were screened, 25 were excluded, and 75']","['nilotinib therapy', 'placebo', 'placebo; nilotinib, 150-mg; or nilotinib', 'Nilotinib vs placebo']","['reduction of α-synuclein oligomers', 'serious adverse events', 'cerebrospinal fluid levels of the dopamine metabolites homovanillic acid', '3,4-dihydroxyphenylacetic acid', 'hyperphosphorylated tau levels', 'Safety, Tolerability, and Potential Biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}]","[{'cui': 'C1721377', 'cui_str': 'nilotinib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0165073', 'cui_str': 'Synucleins'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007807'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0019903', 'cui_str': '4-Hydroxy-3-Methoxyphenylacetic Acid'}, {'cui': 'C0000376', 'cui_str': 'DOPAC'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",100.0,0.23397,"The 150-mg nilotinib group showed an increase in cerebrospinal fluid levels of the dopamine metabolites homovanillic acid (159.80nM; 90% CI, 7.04-312.60nM; P = .04) and 3,4-dihydroxyphenylacetic acid (4.87nM; 90% CI, 1.51-8.23nM; P = .01), and the 300-mg nilotinib group showed an increase in 3,4-dihydroxyphenylacetic acid (7.52nM; 90% CI, 2.35-12.69nM; P = .01).","[{'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Pagan', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Michaeline L', 'Initials': 'ML', 'LastName': 'Hebron', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wilmarth', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Yasar', 'Initials': 'Y', 'LastName': 'Torres-Yaghi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Lawler', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Mundel', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Yusuf', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Starr', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Anjum', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Arellano', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Helen H', 'Initials': 'HH', 'LastName': 'Howard', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, MedStar Georgetown University Hospital, Washington, DC.'}, {'ForeName': 'Wangke', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Mulki', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Tarick', 'Initials': 'T', 'LastName': 'Kurd-Misto', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matar', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Jaeil', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Charbel', 'Initials': 'C', 'LastName': 'Moussa', 'Affiliation': 'Translational Neurotherapeutics Program, Laboratory for Dementia and Parkinsonism, Department of Neurology, Georgetown University Medical Center, Washington, DC.'}]",JAMA neurology,['10.1001/jamaneurol.2019.4200']
959,22154131,Family ties to health program: a randomized intervention to improve vegetable intake in children.,"OBJECTIVE


Evaluate a home-based intervention targeted toward parents to improve vegetable intake in preschool-aged children.
METHODS


Four-month feasibility study of home-based intervention consisting of 4 tailored newsletters and 2 motivational phone calls compared to control; 4 children's books for the control group; and measured pre and post parent-reported physical and social home environment and child vegetable intake in 22 intervention and 21 control homes with a child 2-5 years old assessed with linear regression of group predicting home environment and diet characteristics post-intervention, adjusting for baseline (P < .05 significant).
RESULTS


Intervention increased availability of vegetables (+1.5 ± 2.5 vegetable types vs -0.3 ± 2.7 vegetable types, P = .02), offering fruits and vegetables for snacks (+0.95 ± 1.5 d/wk vs -0.05 ± 1.9 d/wk, P = .04), and self-efficacy (+2.4 ± 4.1 vs -0.3 ± 2.0, P = .02).
CONCLUSIONS AND IMPLICATIONS


The data suggest potential for home-based interventions to alter parent behaviors such as feeding practices and the home physical environment, which may be steps toward increasing vegetable intake in children.",2012,"The data suggest potential for home-based interventions to alter parent behaviors such as feeding practices and the home physical environment, which may be steps toward increasing vegetable intake in children.","['preschool-aged children', 'children']","[""home-based intervention consisting of 4 tailored newsletters and 2 motivational phone calls compared to control; 4 children's books for the control group; and measured pre and post parent-reported physical and social home environment and child vegetable intake"", 'home-based intervention targeted toward parents to improve vegetable intake']","['self-efficacy', 'availability of vegetables']","[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}]",,0.0217145,"The data suggest potential for home-based interventions to alter parent behaviors such as feeding practices and the home physical environment, which may be steps toward increasing vegetable intake in children.","[{'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Tabak', 'Affiliation': 'George Warren Brown School of Social Work, Prevention Research Center in St. Louis, Washington University in St. Louis, MO 63110, USA. rtabak@gwbmail.wustl.edu'}, {'ForeName': 'Deborah F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': ''}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Siega-Riz', 'Affiliation': ''}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': ''}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2011.06.009']
960,22291880,White matter correlates of neuropsychological dysfunction in systemic lupus erythematosus.,"Patients diagnosed with Systemic Lupus Erythematosus have similar levels of neuropsychological dysfunction (i.e., 20-50%) as those with Neuropsychiatric Systemic Lupus Erythematosus (NPSLE). We hypothesized a gradient between cognition and white matter integrity, such that strongest brain-behavior relationships would emerge in NPSLE, intermediate in non-NPSLE, and minimal in controls. We studied thirty-one patients (16 non-NPSLE; 15 NPSLE), ranging in age from 18 to 59 years old (100% female), and eighteen age and gender matched healthy controls. DTI examinations were performed on a 1.5T scanner. A broad neuropsychological battery was administered, tapping attention, memory, processing speed, and executive functioning. The Total z-score consisted of the combined sum of all neuropsychological measures. In control subjects, we found no significant FA-Total z-score correlations. NPSLE, non-NPSLE, and control subjects differed significantly in terms of Total z-score (NPSLE = -2.25+/-1.77, non-NPSLE = -1.22+/-1.03, Controls = -0.10+/-.57; F = 13.2, p<.001). In non-NPSLE subjects, FA within the right external capsule was significantly correlated with Total z-score. In NPSLE subjects, the largest FA-Total z-score clusters were observed within the left anterior thalamic radiation and right superior longitudinal fasciculus. In subsequent analyses the largest number of significant voxels linked FA with the Processing Speed z-score in NPSLE. The current results reflect objective white matter correlates of neuropsychological dysfunction in both NPSLE and (to a lesser degree) in non-NPSLE. non-NPSLE and NPSLE subjects did not differ significantly in terms of depression, as measured by the GDI; thus, previous hypotheses suggesting moderating effects of depression upon neuropsychological performance do not impact the current FA results.",2012,"NPSLE, non-NPSLE, and control subjects differed significantly in terms of Total z-score (NPSLE = -2.25+/-1.77, non-NPSLE = -1.22+/-1.03, Controls = -0.10+/-.57; F = 13.2, p<.001).","['Patients diagnosed with Systemic Lupus Erythematosus', 'thirty-one patients (16 non-NPSLE; 15 NPSLE), ranging in age from 18 to 59 years old (100% female), and eighteen age and gender matched healthy controls', 'systemic lupus erythematosus']",[],"['FA-Total z-score correlations', 'largest FA-Total z-score clusters', 'neuropsychological dysfunction', 'tapping attention, memory, processing speed, and executive functioning', 'Total z-score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}]",31.0,0.0198752,"NPSLE, non-NPSLE, and control subjects differed significantly in terms of Total z-score (NPSLE = -2.25+/-1.77, non-NPSLE = -1.22+/-1.03, Controls = -0.10+/-.57; F = 13.2, p<.001).","[{'ForeName': 'Rex E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, University of New Mexico, Albuquerque, New Mexico, United States of America. rex.jung@gmail.com'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Chavez', 'Affiliation': ''}, {'ForeName': 'Ranee A', 'Initials': 'RA', 'LastName': 'Flores', 'Affiliation': ''}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': ''}, {'ForeName': 'Wilmer L', 'Initials': 'WL', 'LastName': 'Sibbitt', 'Affiliation': ''}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Roldan', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0028373']
961,22392834,Weight loss in obese older adults increases serum sclerostin and impairs hip geometry but both are prevented by exercise training.,"We reported that weight loss induces bone loss which is prevented by exercise training; however, the mechanism for this observation remains unclear. Sclerostin, an inhibitor of bone formation, has been found to increase in states of unloading and may mediate the changes in bone metabolism associated with weight loss and exercise. The objective of the study was to determine the effect of lifestyle intervention in obese older adults on sclerostin levels, and on hip geometry parameters. A total of 107 obese (body mass index [BMI] ≥ 30 kg/m(2)) older (≥65 years) adults were randomly assigned to control, diet, exercise, and combined diet-exercise for 1 year. Sclerostin levels were measured by ELISA at baseline, 6 months, and 12 months, while hip geometry parameters were obtained from bone mineral density (BMD) images done by dual-energy X-ray absorptiometry using hip structure analysis at baseline and 12 months. Both the diet and diet-exercise groups had significant decreases in body weight (-9.6% and -9.4%, respectively), whereas weight was stable in the exercise and control groups. Sclerostin levels increased significantly and progressively in the diet group (6.6% ± 1.7% and 10.5% ± 1.9% at 6 and 12 months, respectively, all p < 0.05), whereas they were unchanged in the other groups; in particular, they were stable in the diet-exercise group (0.7% ± 1.6% and 0.4% ± 1.7% at 6 and 12 months, respectively, all p = 0.05). Hip geometry parameters showed significant decreases in cross-sectional area, cortical thickness, and BMD; and increases in buckling ratio at the narrow neck, intertrochanter, and femoral shaft. These negative changes on bone geometry were not observed in the diet-exercise group. Significant correlations between changes in sclerostin and changes in certain hip geometry parameters were also observed (p < 0.05). In conclusion, the increase in sclerostin levels with weight loss that was prevented by exercise may partly mediate the negative effects of weight loss on bone metabolism and the osteoprotective effect of exercise training.",2012,"Hip geometry parameters showed significant decreases in cross-sectional area, cortical thickness, and BMD; and increases in buckling ratio at the narrow neck, intertrochanter, and femoral shaft.","['107 obese (body mass index [BMI] ≥ 30\u2009kg/m(2)) older (≥65 years) adults', 'obese older adults']","['control, diet, exercise, and combined diet-exercise', 'lifestyle intervention']","['bone geometry', 'weight', 'serum sclerostin and impairs hip geometry', 'Weight loss', 'cross-sectional area, cortical thickness, and BMD', 'body weight', 'buckling ratio at the narrow neck, intertrochanter, and femoral shaft', 'certain hip geometry parameters', 'Sclerostin levels']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0542562', 'cui_str': 'Buckle (physical object)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",107.0,0.0143644,"Hip geometry parameters showed significant decreases in cross-sectional area, cortical thickness, and BMD; and increases in buckling ratio at the narrow neck, intertrochanter, and femoral shaft.","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Geriatrics, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Corinn', 'Initials': 'C', 'LastName': 'Sadler', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': ''}, {'ForeName': 'Krupa', 'Initials': 'K', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Chode', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Sinacore', 'Affiliation': ''}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': ''}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': ''}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.1560']
962,22266602,Efficacy of non-selective β-blockers as adjunct to endoscopic prophylactic treatment for gastric variceal bleeding: a randomized controlled trial.,"BACKGROUND & AIMS


Gastric variceal obturation (GVO) therapy is the current treatment of choice for gastric variceal bleeding (GVB). However, the efficacy of non-selective β-blockers (NSBB) in the secondary prevention of GVB is still debatable. This study aimed at evaluating the efficacy of additional NSBB to repeated GVO in the secondary prevention of GVB.
METHODS


From April 2007 to March 2011, 95 patients with GVB after primary hemostasis using GVO were enrolled. Repeated GVO were performed until GV eradication. Forty-eight and 47 patients were randomized into the GVO alone group (Group A) and the GVO+NSBB group (Group B), respectively. Primary outcomes in terms of re-bleeding and overall survival were analyzed by multivariate analysis.
RESULTS


After a mean follow-up of 18.10 months in group A, 26 patients bled and 20 died. In group B, 22 patients bled and 22 died after a mean follow-up of 20.29 months. The overall re-bleeding and survival rates analyzed by the Kaplan-Meier method were not different between the two groups (p=0.336 and 0.936, respectively). The model of end-stage liver disease (MELD) score and main portal vein thrombosis (MPT) were independent determinants of re-bleeding while MPT and re-bleeding were independent factors of mortality by time-dependent Cox-regression model. Asthenia was the most common adverse event and was higher in group B (p<0.001).
CONCLUSIONS


Adding NSBB therapy to repeated GVO provides no benefit for the secondary prevention of bleeding and mortality in patients with GVB.",2012,"The overall re-bleeding and survival rates analyzed by the Kaplan-Meier method were not different between the two groups (p=0.336 and 0.936, respectively).","['Forty-eight and 47 patients', 'gastric variceal bleeding (GVB', 'gastric variceal bleeding', 'From April 2007 to March 2011, 95 patients with GVB after primary hemostasis using GVO were enrolled', 'patients with GVB']","['non-selective β-blockers', 'GVO alone', 'endoscopic prophylactic treatment', 'Gastric variceal obturation (GVO) therapy', 'GVO+NSBB', 'non-selective β-blockers (NSBB']","['bleeding and mortality', 'Asthenia', 're-bleeding and overall survival', 'overall re-bleeding and survival rates', 'model of end-stage liver disease (MELD) score and main portal vein thrombosis (MPT']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0745744', 'cui_str': 'End Stage Liver Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis (disorder)'}]",95.0,0.0625398,"The overall re-bleeding and survival rates analyzed by the Kaplan-Meier method were not different between the two groups (p=0.336 and 0.936, respectively).","[{'ForeName': 'Hung-Hsu', 'Initials': 'HH', 'LastName': 'Hung', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jung', 'Initials': 'CJ', 'LastName': 'Chang', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Endoscopy Center for Diagnosis and Treatment, Taipei Veterans General Hospital, Taipei, Taiwan. Electronic address: mchou@vghtpe.gov.tw.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Liao', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Municipal Gan-Dau Hospital, Taipei, Taiwan.'}, {'ForeName': 'Che-Chang', 'Initials': 'CC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Han-Chieh', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Fa-Yauh', 'Initials': 'FY', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shou-Dong', 'Initials': 'SD', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Deparement of Medicine, School of Medicine, National Defense Medical Center, Taipei, Taiwan; Cheng Hsin General Hospital, Taipei, Taiwan.'}]",Journal of hepatology,['10.1016/j.jhep.2011.12.021']
963,22266603,A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C.,"BACKGROUND & AIMS


Genotype 6 chronic hepatitis C (HCV) is encountered predominantly in Southeast Asia and data on optimal treatment strategy is limited. This study was aimed at assessing the rate and predictors of sustained virological response (SVR) in genotype 6 chronic HCV following 48 and 24 weeks of pegylated interferon and ribavirin therapy.
METHODS


This investigator-initiated, open-label randomized trial was conducted in Vietnam between 2008 and 2010. One hundred and five treatment-naïve HCV genotype 6 patients were randomized to either 48-week (N=70) or 24-week (N=35) duration of pegylated interferon (PEG-IFN) alfa-2a 180 mcg/week and ribavirin (RBV) 15mg/kg/day; 92 patients completed the study (63 in the 48-week and 29 in the 24-week group, respectively). Primary outcome was sustained virological response (SVR) as intention-to-treat analysis.
RESULTS


There was no statistical difference in SVR between 48-week and 24-week treated groups (71% vs. 60%, respectively; p=0.24). In the 48-week and 24-week treatment groups, 81% and 80% of cases achieved rapid virological response (RVR) (p=0.86), and 86% and 80% achieved complete early virological response (p=0.45). Among those patients with RVR, SVR was in 86% (48-weeks), and 75% (24-weeks) of cases, whereas following non-RVR, only 8% of cases had an SVR with 48-week treatment duration.
CONCLUSIONS


Overall, RVR was achieved in the majority of genotype 6 patients and, in those patients, similar and high rates of SVR were noted following 24-week and 48-week therapy. This observation, however, needs validation in a larger study to demonstrate non-inferiority of the shorter duration therapy. In non-RVR patients, even 48-week therapy achieved low SVR rates.",2012,"There was no statistical difference in SVR between 48-week and 24-week treated groups (71% vs. 60%, respectively; p=0.24).","['genotype 6 chronic hepatitis C', 'HCV genotype 6 patients', 'genotype 6 chronic HCV following 48 and 24 weeks of', 'Vietnam between 2008 and 2010', 'One hundred and five treatment-naïve']","['combination pegylated interferon and ribavirin therapy', 'pegylated interferon and ribavirin therapy', 'pegylated interferon (PEG-IFN) alfa-2a 180 mcg/week and ribavirin (RBV']","['complete early virological response', 'rate and predictors of sustained virological response (SVR', 'RVR', 'SVR', 'low SVR rates', 'rapid virological response (RVR', 'sustained virological response (SVR) as intention-to-treat analysis']","[{'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",,0.0880686,"There was no statistical difference in SVR between 48-week and 24-week treated groups (71% vs. 60%, respectively; p=0.24).","[{'ForeName': 'Pham Thi', 'Initials': 'PT', 'LastName': 'Thu Thuy', 'Affiliation': 'Medic Medical Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Chalermrat', 'Initials': 'C', 'LastName': 'Bunchorntavakul', 'Affiliation': 'Rajavithi Hospital, Ministry of Public Health, Bangkok, Thailand; Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Tan Dat', 'Affiliation': 'Medic Medical Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Rajender Reddy', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: rajender.reddy@uphs.upenn.edu.'}]",Journal of hepatology,['10.1016/j.jhep.2011.12.020']
964,22266605,A novel biliary stent loaded with (125)I seeds in patients with malignant biliary obstruction: preliminary results versus a conventional biliary stent.,"BACKGROUND & AIMS


Stenting is a palliative therapy method for relieving malignant biliary obstruction. The aim of this study was to evaluate the safety and effectiveness of an irradiation stent compared to a conventional biliary stent in patients with biliary obstruction caused by both primary and metastatic adenocarcinomas.
METHODS


Participants were randomly assigned to receive treatment with a biliary irradiation stent (irradiation stent group) or a conventional biliary stent (control group). After stent implantation, the outcomes were measured in terms of relief of obstructive jaundice, survival time, complications related to the procedure. A p value of less than 0.05 indicated a significant difference.
RESULTS


The stents were successfully placed in all the 23 patients. The obstructive jaundice was relieved in all patients except three in the control group. The median and mean overall survivals in the irradiation stent group were higher than those in the control group (7.40 months versus 2.50 months, 8.03 months versus 3.36 months, p=0.006). The patients with stent patent at 3, 6, and 12 months in the irradiation stent group were 11 (91.7%), 7 (58.3%), and 1 (8.3%), respectively. While in the control group, 4 (36.4%), 1 (9.1%), and 0 (0%), respectively. There were no significant differences in the complications related to stent insertion between the two groups.
CONCLUSIONS


This interim analysis shows that treatment with the biliary intraluminal irradiation stent in patients with biliary obstruction caused by adenocarcinomas appears safe and technically feasible, has benefits in relieving jaundice, and seems to extend survival when compared to a conventional biliary stent.",2012,"There were no significant differences in the complications related to stent insertion between the two groups.
","['patients with biliary obstruction caused by both primary and metastatic adenocarcinomas', 'patients with biliary obstruction', 'patients with malignant biliary obstruction', 'Participants']","['biliary irradiation stent (irradiation stent group) or a conventional biliary stent (control group', 'novel biliary stent loaded with (125)I seeds', 'conventional biliary stent', 'irradiation stent', 'biliary intraluminal irradiation stent']","['safety and effectiveness', 'relief of obstructive jaundice, survival time, complications related to the procedure', 'median and mean overall survivals', 'obstructive jaundice']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}]","[{'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0183512', 'cui_str': 'Biliary stent (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",23.0,0.0361439,"There were no significant differences in the complications related to stent insertion between the two groups.
","[{'ForeName': 'Hai-Dong', 'Initials': 'HD', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Jin-He', 'Initials': 'JH', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Shi-Cheng', 'Initials': 'SC', 'LastName': 'He', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Deng', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Yong-Lin', 'Initials': 'YL', 'LastName': 'Qin', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Guo-Zhao', 'Initials': 'GZ', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Coldwell', 'Affiliation': 'Department of Radiology, University of Louisville Hospital, 530 South Jackson Street, Louisville, KY 40202, USA.'}, {'ForeName': 'Gao-Jun', 'Initials': 'GJ', 'LastName': 'Teng', 'Affiliation': 'Department of Radiology, Zhong-Da Hospital, Medical School, Southeast University, 87 Dingjiaqiao Road, Nanjing 210009, China. Electronic address: gjteng@vip.sina.com.'}]",Journal of hepatology,['10.1016/j.jhep.2011.12.018']
965,22245891,"Vandetanib in patients with inoperable hepatocellular carcinoma: a phase II, randomized, double-blind, placebo-controlled study.","BACKGROUND & AIMS


Inhibitors of vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR) have shown anti-tumor activities in advanced hepatocellular carcinoma (HCC). The present study evaluated the efficacy and safety of vandetanib, an oral inhibitor of both VEGFR and EGFR, in patients with unresectable advanced HCC.
METHODS


Eligible patients were randomized 1:1:1 to receive vandetanib 300mg/day, vandetanib 100mg/day, or placebo. Upon disease progression, all patients had the option to receive open-label vandetanib 300mg/day. The primary objective was to evaluate tumor stabilization rate (complete response+partial response+stable disease ⩾4months). Secondary assessments included progression-free survival (PFS), overall survival (OS) and safety. Biomarker studies included circulating pro-angiogenic factors and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
RESULTS


Sixty-seven patients were randomized to vandetanib 300mg (n=19), vandetanib 100mg (n=25) or placebo (n=23) groups. Twenty-nine patients entered open-label treatment. Vandetanib induced a significant increase in circulating VEGF and decrease in circulating VEGFR levels. In both vandetanib arms, tumor stabilization rate was not significantly different from placebo: 5.3% (vandetanib 300mg), 16.0% (vandetanib 100mg) and 8.7% (placebo). DCE-MRI did not detect significant vascular change after vandetanib treatment. Although trends of improved PFS and OS after vandetanib treatment were found, they were statistically insignificant. The most common adverse events were diarrhea and rash, whose incidence did not differ significantly between treatment groups.
CONCLUSIONS


Vandetanib has limited clinical activity in HCC. The safety profile was consistent with previous studies.",2012,"In both vandetanib arms, tumor stabilization rate was not significantly different from placebo: 5.3% (vandetanib 300mg), 16.0% (vandetanib 100mg) and 8.7% (placebo).","['advanced hepatocellular carcinoma (HCC', 'patients with inoperable hepatocellular carcinoma', 'Sixty-seven patients', 'Eligible patients', 'Twenty-nine patients entered open-label treatment', 'patients with unresectable advanced HCC']","['Vandetanib', 'placebo', 'vandetanib, an oral inhibitor of both VEGFR and EGFR', 'vandetanib 300mg/day, vandetanib 100mg/day, or placebo', 'vandetanib 100mg (n=25) or placebo', 'vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR']","['diarrhea and rash', 'circulating VEGFR levels', 'PFS and OS', 'progression-free survival (PFS), overall survival (OS) and safety', 'circulating VEGF', 'tumor stabilization rate']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1121849', 'cui_str': 'Vandetanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3152967', 'cui_str': 'Vandetanib 100 MG'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",67.0,0.36223,"In both vandetanib arms, tumor stabilization rate was not significantly different from placebo: 5.3% (vandetanib 300mg), 16.0% (vandetanib 100mg) and 8.7% (placebo).","[{'ForeName': 'Chiun', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Departments of Oncology and Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tsai-Sheng', 'Initials': 'TS', 'LastName': 'Yang', 'Affiliation': 'Division of Hematology and Oncology, Chang-Gung Memorial Hospital Linkou, Linkou, Taiwan.'}, {'ForeName': 'Teh-Ia', 'Initials': 'TI', 'LastName': 'Huo', 'Affiliation': 'Division of Gastroenterology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ruey-Kuen', 'Initials': 'RK', 'LastName': 'Hsieh', 'Affiliation': 'Division of Hematology and Oncology, Mackay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Shou', 'Initials': 'WS', 'LastName': 'Hwang', 'Affiliation': 'Division of Hematology and Oncology, Chie-Mei Medical Center Yong-Kang Branch, Tainan, Taiwan.'}, {'ForeName': 'Tsai-Yuan', 'Initials': 'TY', 'LastName': 'Hsieh', 'Affiliation': 'Division of Gastroenterology, Tri-Service General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Tsung', 'Initials': 'WT', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology and Oncology, Chie-Mei Medical Center Liouying Branch, Tainan, Taiwan.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Cancer Treatment Center, Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Meng', 'Affiliation': 'AstraZeneca, Taipei, Taiwan.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'Departments of Oncology and Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: alcheng@ntu.edu.tw.'}]",Journal of hepatology,['10.1016/j.jhep.2011.12.013']
966,22137666,"A randomized, masked study of weekly erythropoietin dosing in preterm infants.","OBJECTIVE


To compare reticulocyte responses of once-per-week erythropoietin (EPO) dosing with 3-times-a-week dosing in preterm infants.
STUDY DESIGN


Infants weighing ≤ 1500 g and ≥ 7 days of age were randomized to once-per-week EPO, 1200 U/kg/dose, or 3-times-a-week EPO, 400 U/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts (ARCs), transfusions, phlebotomy losses, and adverse events were recorded.
RESULTS


Twenty preterm infants (962 ± 55 g, 27.9 ± 0.4 weeks, 17 ± 3 days of age) were enrolled. Groups were similar at baseline. Infants in both groups had increased ARCs, which were similar between treatment groups at the start and end of 4 weeks. Hematocrit remained stable, and similar numbers of transfusions were administered. No adverse effects of either dosing schedule were noted.
CONCLUSIONS


Preterm infants respond to weekly EPO by increasing ARCs and maintaining hematocrit. We speculate that once-per-week EPO dosing might be beneficial to preterm infants requiring increased erythropoiesis.",2012,"No adverse effects of either dosing schedule were noted.
","['Infants weighing ≤ 1500 g and ≥ 7 days of age', 'Twenty preterm infants (962 ± 55 g, 27.9 ± 0.4 weeks, 17 ± 3 days of age) were enrolled', 'preterm infants', 'preterm infants requiring increased erythropoiesis']","['erythropoietin', 'erythropoietin (EPO', 'iron and vitamin supplementation']","['Complete blood counts, absolute reticulocyte counts (ARCs), transfusions, phlebotomy losses, and adverse events', 'adverse effects']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0014819', 'cui_str': 'Erythropoiesis'}]","[{'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1533658', 'cui_str': 'Vitamin supplement therapy'}]","[{'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",20.0,0.0759296,"No adverse effects of either dosing schedule were noted.
","[{'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Ohls', 'Affiliation': 'Department of Pediatrics, University of New Mexico, Albuquerque, NM, USA. rohls@salud.unm.edu'}, {'ForeName': 'Mashid', 'Initials': 'M', 'LastName': 'Roohi', 'Affiliation': ''}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Peceny', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Schrader', 'Affiliation': ''}, {'ForeName': 'Ryann', 'Initials': 'R', 'LastName': 'Bierer', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2011.10.026']
967,22337905,Estimation of maximal cortisol secretion rate in healthy humans.,"CONTEXT


Cortisol secretion is related to ACTH concentration by a sigmoidal dose-response curve, in which high ACTH concentrations drive maximal cortisol secretion rates (CSR(max)).
OBJECTIVE


We sought to estimate CSR(max) and free cortisol half-life in healthy humans (n = 21) using numerical methods applied to data acquired during cosyntropin (250 μg) stimulation. We also evaluated the effect of overnight dexamethasone (DEX; 1 mg) vs. placebo on estimates of CSR(max) and free cortisol half-life.
DESIGN


This study was a double-blind, placebo-controlled, randomized order of overnight DEX vs. placebo, cosyntropin (250 μg) stimulation with frequent serum cortisol sampling and computer-assisted numerical analysis.
SETTING


The study was conducted at a single academic medical center.
PARTICIPANTS


Twenty-one healthy adult subjects (15 females and six males), mean aged 46 yr, participated in the study.
INTERVENTION


Intervention in the study included DEX vs. placebo pretreatment, cosyntropin (250 μg) iv with frequent cortisol sampling.
MAIN OUTCOME MEASURES


CSR(max) and free cortisol half-life estimates, R² for goodness of fit, were measured.
RESULTS


Mean ± sd CSR(max) was 0.44 ± 0.13 nm/second, with free cortisol half-life of 2.2 ± 1.1 min. DEX did not significantly affect estimates of CSR(max) or free cortisol half-life. Our model accounts for most of the variability of measured cortisol concentrations (overall R² = 90.9 ±11.0%) and was more accurate (P = 0.004) during DEX suppression (R² = 94.6 ± 4.6%) compared with placebo (R² = 87.2 ± 8.7%).
CONCLUSIONS


Application of a mass-action model under conditions of cosyntropin stimulation provides a relatively simple method for estimation CSR(max) that accurately predicts measured cortisol concentrations. DEX administration did not significantly affect estimates of CSR(max) or free cortisol half-life.",2012,DEX did not significantly affect estimates of CSR(max) or free cortisol half-life.,"['single academic medical center', 'Twenty-one healthy adult subjects (15 females and six males), mean aged 46 yr, participated in the study', 'healthy humans', 'healthy humans (n = 21) using numerical methods applied to data acquired during cosyntropin (250 μg) stimulation']","['DEX', 'overnight DEX vs. placebo, cosyntropin (250 μg) stimulation with frequent serum cortisol sampling and computer-assisted numerical analysis', 'placebo', 'DEX vs. placebo pretreatment, cosyntropin (250 μg) iv with frequent cortisol sampling', 'overnight dexamethasone (DEX']","['CSR(max) and free cortisol half-life estimates, R² for goodness of fit', 'maximal cortisol secretion rate', 'CSR(max', 'cortisol concentrations']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010192', 'cui_str': 'tetracosactide'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0729349', 'cui_str': 'Serum cortisol (substance)'}, {'cui': 'C0028645', 'cui_str': 'Numerical Analysis, Computer-Assisted'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0443476', 'cui_str': 'Free cortisol (substance)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",21.0,0.0714516,DEX did not significantly affect estimates of CSR(max) or free cortisol half-life.,"[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Dorin', 'Affiliation': 'Medical Service 111/Endocrinology, New Mexico Veterans Affairs Healthcare System, 1501 San Pedro Boulevard SE, Albuquerque, New Mexico 87108, USA. rdorin@salud.unm.edu'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Qiao', 'Affiliation': ''}, {'ForeName': 'Clifford R', 'Initials': 'CR', 'LastName': 'Qualls', 'Affiliation': ''}, {'ForeName': 'Frank K', 'Initials': 'FK', 'LastName': 'Urban', 'Affiliation': ''}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2011-2227']
968,22245896,"Relationship between baseline hepatic status and outcome, and effect of sorafenib on liver function: SHARP trial subanalyses.","BACKGROUND & AIMS


Hepatic markers are utilized in many classification systems of patients with hepatocellular carcinoma and, by measuring organ damage and tumor stage, can influence treatment. Moreover, elevated serum concentrations of aminotransferases and alpha-fetoprotein are indicators of poor prognosis in patients with hepatocellular carcinoma. We examined the effects of sorafenib on hepatic markers by performing exploratory subset analyses of the Sorafenib HCC Assessment Randomized Protocol (SHARP) trial in patients categorized by baseline concentrations of alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, and bilirubin; and by evaluating the effects of sorafenib on bilirubin concentrations during treatment.
METHODS


Patients (n=602) were grouped by baseline concentrations of alanine aminotransferase/aspartate aminotransferase (not significantly elevated, mildly elevated, or moderately elevated), alpha-fetoprotein (normal or elevated), and bilirubin (normal or elevated). Bilirubin was measured at baseline and on day 1 of each cycle.
RESULTS


Patients with elevated baseline concentrations of alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin had shorter overall survival (OS) than those with normal baseline concentrations, irrespective of treatment group. No notable differences in safety profiles were observed between patients with normal vs. elevated alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin. Median changes from baseline in bilirubin concentration at the last cycle of treatment were +0.17 and +0.19 mg/dl in the sorafenib and placebo groups, respectively.
CONCLUSIONS


These subset analyses suggest that sorafenib is safe and effective for hepatocellular carcinoma, irrespective of baseline alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin concentration and that hepatic function remains stable over the course of sorafenib therapy.",2012,"No notable differences in safety profiles were observed between patients with normal vs. elevated alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin.","['patients with hepatocellular carcinoma', 'Patients (n=602', 'not significantly elevated, mildly elevated, or moderately elevated), alpha-fetoprotein (normal or elevated), and bilirubin (normal or elevated', 'patients categorized by baseline concentrations of alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, and bilirubin']","['placebo', 'sorafenib']","['Bilirubin', 'baseline alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin concentration', 'safety profiles', 'alanine aminotransferase/aspartate aminotransferase', 'alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin', 'bilirubin concentrations', 'alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin had shorter overall survival (OS', 'bilirubin concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0002210', 'cui_str': 'alpha-Fetoproteins'}, {'cui': 'C0427734', 'cui_str': 'Bilirubin concentration, test strip measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",602.0,0.173434,"No notable differences in safety profiles were observed between patients with normal vs. elevated alanine aminotransferase/aspartate aminotransferase, alpha-fetoprotein, or bilirubin.","[{'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Raoul', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France; Institut National de la Santé et de la Recherche Médicale (INSERM) U991, Rennes, France. Electronic address: raouljl@marseille.fnclcc.fr.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Bruix', 'Affiliation': ""Barcelona Clínic Liver Cancer (BCLC) Group, Liver Unit, CIBERehd, Institut d'Investigacions Biomèdiques, August Pi i Sunyer (IDIBAPS), Hospital Clínic Barcelona, Barcelona, Spain.""}, {'ForeName': 'Tim F', 'Initials': 'TF', 'LastName': 'Greten', 'Affiliation': 'Medizinische Hochschule Hannover, Abteilung fur Gastroenterologie, Hepatologie und Endokrinologie, Hannover, Germany.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Sherman', 'Affiliation': 'Toronto General Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'National Cancer Institute, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Foundation, Milan, Italy.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hilgard', 'Affiliation': 'University Hospital of Essen, Essen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Scherubl', 'Affiliation': 'Medizinische Klinik ""Charite"", Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Max E', 'Initials': 'ME', 'LastName': 'Scheulen', 'Affiliation': 'Innere Klinik (Tumorforschung), West German Cancer Center, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Germanidis', 'Affiliation': 'AHEPA University Hospital, First Department of Medicine, Thessaloniki, Greece.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dominguez', 'Affiliation': 'Centre Oscar Lambret, Departement de Cancerologie Digestive et Urologique, Lille, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'St. Chiara University Hospital, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Nadel', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Montville, NJ, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Moscovici', 'Affiliation': 'Bayer Schering Pharma, Milan, Italy.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Voliotis', 'Affiliation': 'Bayer Schering Pharma, Milan, Italy.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': ""Barcelona Clínic Liver Cancer (BCLC) Group, Liver Unit, CIBERehd, Institut d'Investigacions Biomèdiques, August Pi i Sunyer (IDIBAPS), Hospital Clínic Barcelona, Barcelona, Spain; Mount Sinai Liver Cancer Program, Mount Sinai School of Medicine, New York, NY, USA; Institució Catalana de Recerca I Estudis Avançats, Catalonia, Spain.""}]",Journal of hepatology,['10.1016/j.jhep.2011.12.009']
969,32115392,Clinical pharmacists in diabetes management: What do minority patients with uncontrolled diabetes have to say?,"OBJECTIVE


Clinical pharmacist support for patients with type 2 diabetes mellitus (T2DM) can optimize patient outcomes and medication adherence. However, there is limited understanding of what pharmacist roles patients perceive as most helpful in T2DM management interventions. This study describes experiences of minority patients with uncontrolled T2DM in terms of perceived pharmacist helpfulness and specific roles found to be most helpful within diabetes management.
DESIGN


A secondary analysis of a 2-year randomized, crossover trial was conducted.
SETTING AND PARTICIPANTS


This study included 244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model.
OUTCOME MEASURES


The patients completed a mixed-methods survey regarding their experience with the intervention that included a general helpfulness rating on a 10-point unipolar Likert scale and described the support qualitatively, including their perception of the pharmacist roles. Thematic analysis guided coding of the responses.
RESULTS


One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist. Of these, 108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women. The median rating of clinical pharmacist helpfulness was 10 (very helpful). Only 10 (7%) participants rated pharmacist helpfulness as 1 (not at all helpful). ""Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination."" Miscommunication related to scheduling was the most common reason cited for not meeting with the clinical pharmacist.
CONCLUSION


This sample of minority patients with uncontrolled T2DM recognized many roles outlined within the American Pharmacists Association Medication Therapy Management framework. Patient experiences with clinical pharmacist T2DM support are crucial for developing effective programs, maximizing patient engagement, satisfying patient needs, and ensuring that a program's intended purpose aligns with the patient perspective.",2020,"Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination.""","['minority patients with uncontrolled T2DM', '108 (74%) were African American, 39 (27%) were Hispanic, and 101 (69%) were women', 'minority patients with uncontrolled diabetes', '244 African American and Hispanic adults with uncontrolled T2DM who received clinical pharmacist support within a team-based model', 'One hundred forty-seven (60%) patients completed the survey and had at least 1 encounter with a clinical pharmacist', 'patients with type 2 diabetes mellitus (T2DM']",[],"['pharmacist helpfulness', 'median rating of clinical pharmacist helpfulness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}]",244.0,0.0432504,"Medication education and management"" was the most frequently perceived supportive role of the clinical pharmacists, followed by ""non-medication-related patient education,"" ""social support,"" and ""care coordination.""","[{'ForeName': 'Nadia A', 'Initials': 'NA', 'LastName': 'Nabulsi', 'Affiliation': ''}, {'ForeName': 'Connie H', 'Initials': 'CH', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Tilton', 'Affiliation': ''}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': ''}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Sharp', 'Affiliation': ''}]",Journal of the American Pharmacists Association : JAPhA,['10.1016/j.japh.2020.01.024']
970,21427067,"Efficacy of venlafaxine for the prevention and relief of oxaliplatin-induced acute neurotoxicity: results of EFFOX, a randomized, double-blind, placebo-controlled phase III trial.","BACKGROUND


Oxaliplatin neurosensory toxicity is dose limiting and may present as acute symptoms and/or cumulative peripheral neuropathy.
PATIENTS AND METHODS


From October 2005 to May 2008, patients with oxaliplatin-induced acute neurotoxicity were randomized into a double-blind study, to receive either venlafaxine 50 mg 1 h prior oxaliplatin infusion and venlafaxine extended release 37.5 mg b.i.d. from day 2 to day 11 or placebo. Neurotoxicity was evaluated using numeric rating scale (NRS) for pain intensity and experienced relief under treatment, the Neuropathic Pain Symptom Inventory and the oxaliplatin-specific neurotoxicity scale. The primary end point was the percentage of patients with a 100% relief under treatment.
RESULTS


Forty-eight patients were included (27 males, median age: 67.6 years). Most patients had colorectal cancer (72.9%). Median number of cycles administered at inclusion was 4.5 (mean cumulative oxaliplatin dose: 684.6 mg). Twenty out of 24 patients in arm A (venlafaxine) and 22 out of 24 patients in arm B (placebo) were assessable for neurotoxicity. Based on the NRS, full relief was more frequent in the venlafaxine arm: 31.3% versus 5.3% (P=0.03). Venlafaxine side-effects included grade 1-2 nausea (43.1%) and asthenia (39.2%) without grade 3-4 events.
CONCLUSION


Venlafaxine has clinical activity against oxaliplatin-induced acute neurosensory toxicity.",2012,"Based on the NRS, full relief was more frequent in the venlafaxine arm: 31.3% versus 5.3% (P=0.03).","['induced acute neurotoxicity', 'Forty-eight patients were included (27 males, median age: 67.6 years', 'Twenty out of 24 patients in arm A', 'From October 2005 to May 2008, patients with oxaliplatin-induced acute neurotoxicity']","['Venlafaxine', 'placebo', 'EFFOX', 'venlafaxine', 'arm B (placebo', 'oxaliplatin', 'venlafaxine 50 mg 1 h prior oxaliplatin infusion and venlafaxine extended release 37.5 mg b.i.d']","['grade 1-2 nausea', 'colorectal cancer', 'percentage of patients with a 100% relief under treatment', 'Median number of cycles', 'asthenia', 'Neurotoxicity', 'neurotoxicity', 'numeric rating scale (NRS) for pain intensity and experienced relief under treatment, the Neuropathic Pain Symptom Inventory and the oxaliplatin-specific neurotoxicity scale']","[{'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1123786', 'cui_str': 'venlafaxine 50 MG'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0222045'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",48.0,0.465784,"Based on the NRS, full relief was more frequent in the venlafaxine arm: 31.3% versus 5.3% (P=0.03).","[{'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Durand', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris. Electronic address: jean-philippe.durand@cch.aphp.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Deplanque', 'Affiliation': 'Department of Medical Oncology, Saint Joseph Hospital, Paris.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Montheil', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Gornet', 'Affiliation': 'Department of Gastro-Enterology, Saint Louis Teaching Hospital, AP-HP, Paris.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Scotte', 'Affiliation': 'Department of Medical Oncology, Georges Pompidou European Hospital, AP-HP, Paris.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mir', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cessot', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Coriat', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Raymond', 'Affiliation': 'Department of Medical Oncology, Beaujon Teaching Hospital, AP-HP, Clichy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mitry', 'Affiliation': 'Department of Gastro-Enterology, Ambroise Paré Teaching Hospital, AP-HP, Boulogne-Billancourt.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Herait', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yataghene', 'Affiliation': 'Oncology Unit, Sanofi Aventis France, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Goldwasser', 'Affiliation': 'Department of Medical Oncology, Cochin Teaching Hospital, AP-HP, Université Paris Descartes, Paris.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr045']
971,31398258,Randomized controlled trial on the effect of an online decision aid for young female cancer patients regarding fertility preservation.,"STUDY QUESTION


Does the use of an online decision aid (DA) about fertility preservation (FP), in addition to standard counselling by a specialist in reproductive medicine, reduce decisional conflict compared to standard counselling alone?
SUMMARY ANSWER


Female cancer patients who could make use of the online DA had a significantly lower short-term decisional conflict score.
WHAT IS KNOWN ALREADY


Nowadays, female cancer patients have several options for preserving fertility, but having to decide whether to opt for FP within a short time frame after cancer diagnosis and before the start of treatment is challenging. According to previous studies focussing mainly on breast cancer patients, decisional conflict among these women is high, and they have expressed the need for additional support.
STUDY DESIGN, SIZE, DURATION


The study was a randomized controlled trial including female cancer patients who were referred by their treating oncologist to a specialist in reproductive medicine for fertility counselling. Participants were randomly assigned to the control group (counselling only) or to the intervention group (counselling and additional use of the online DA immediately after counselling). Recruitment was ongoing from July 2016 to December 2017 at eight fertility centres in Switzerland and Germany.
PARTICIPANTS/MATERIALS, SETTING, METHODS


The online DA was developed by an interdisciplinary team of specialists in reproductive medicine, gynaecologists, oncologists and psychologists. Of 79 recruited participants, 59 completed the first assessment and could therefore be enrolled in the study. They were asked to complete an online questionnaire at three time points: at T1, after counselling (control group, n = 27) or after counselling and the additional use of the DA (intervention group, n = 24); at T2, 1 month later (N = 41: control group, n = 23; intervention group, n = 18); and at T3, 12 months later (N = 37: control group, n = 20; intervention group, n = 17). The survey comprised questions about fertility-related knowledge, attitude towards FP, willingness to undergo FP and socio-demographic data, as well as the decisional conflict and decisional regret scales.
MAIN RESULTS AND THE ROLE OF CHANCE


All participants showed low decisional conflict scores. Women who used the online DA in addition to counselling (intervention group) showed a significantly lower total score on the Decisional Conflict Scale (DCS) compared to the control group at T1 (P = 0.008; M = 12.15, SD = 4.38; 95% CI, 3.35-20.95) and at T2 (P = 0.043; M = 9.35, SD = 4.48; 95% CI, 0.31-18.38). At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, -3.78 to 17.51). The majority of participants had already made a decision regarding FP (yes or no) at T1 (72.5%): 91.7% in the intervention group compared to 55.6% in the control group (P = 0.014). Those who had decided already at T1 showed significantly lower decisional conflict (P = 0.007; M = 13.69, SD = 4.89; 95% CI, 3.86-23.52). The average number of DA sessions per user was 2.23, and 80.8% of the participants completed the DA's value clarification exercises. Participants in the intervention group were satisfied with the DA and would recommend it to other patients.
LIMITATIONS, REASONS FOR CAUTION


The recruitment of participants was challenging because of the emotionally difficult situation patients were in. This led to the limited sample size for final analysis. Education levels were high in two-thirds of the participants. It is difficult to say whether the DA would be equally effective in women with a lower educational background.
WIDER IMPLICATIONS OF THE FINDINGS


There is evidence that the DA served as a helpful complement to the decision-making process for young female cancer patients qualifying for FP. This is, to our knowledge, the first randomized controlled trial evaluating a DA targeted at patients with several cancer types and in a language other than English (i.e. German). This study contributes to extending the range of the still limited number of DAs in the context of FP.
STUDY FUNDING/COMPETING INTEREST(S)


The study was supported by a research grant of the Swiss Cancer Research. The authors declare that no competing interests exist.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov, trial no. NCT02404883.
TRIAL REGISTRATION DATE


19 March 2015.
DATE OF FIRST PATIENT’S ENROLMENT


4 July 2016.",2019,"At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, -3.78 to 17.51).","['Of 79 recruited participants, 59 completed the first assessment and could therefore be enrolled in the study', 'The online DA was developed by an interdisciplinary team of specialists in reproductive medicine, gynaecologists, oncologists and psychologists', 'young female cancer patients qualifying for FP', 'patients with several cancer types and in a language other than English (i.e. German', 'Female cancer patients who could make use of the online DA', 'female cancer patients', 'female cancer patients who were referred by their treating oncologist to a specialist in reproductive medicine for fertility counselling', 'July 2016 to December 2017 at eight fertility centres in Switzerland and Germany', 'young female cancer patients regarding fertility preservation', 'women with a lower educational background']","['online decision aid', 'control group (counselling only) or to the intervention group (counselling and additional use of the online DA immediately after counselling', 'online decision aid (DA) about fertility preservation (FP']","['average number of DA sessions', 'decisional conflict', 'mean total score of the DCS', 'short-term decisional conflict score', 'total score on the Decisional Conflict Scale (DCS', 'low decisional conflict scores', 'Education levels']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1171194', 'cui_str': 'Fertility Preservation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1171194', 'cui_str': 'Fertility Preservation'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",79.0,0.110846,"At T3, the mean total score of the DCS was still lower in the intervention group compared to the control group; however, this group difference was no longer significant (P = 0.199, M = 6.86, SD = 5.24; 95% CI, -3.78 to 17.51).","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ehrbar', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Urech', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rochlitz', 'Affiliation': 'Medical Oncology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Zanetti Dällenbach', 'Affiliation': 'Gynecology and Gynaecologic Oncology, St. Claraspital Basel, Basel, Switzerland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Moffat', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Stiller', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Germeyer', 'Affiliation': ""Division of Gynaecological Endocrinology and Reproductive Medicine, University Women's Hospital, University Hospital of Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Nawroth', 'Affiliation': 'Centre for Infertility, Prenatal Medicine, Endocrinology and Osteology, Amedes Experts, Hamburg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Dangel', 'Affiliation': 'Centre for Infertility, Prenatal Medicine, Endocrinology and Osteology, Amedes Experts, Hamburg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Findeklee', 'Affiliation': ""Obstetrics and Reproductive Medicine, University Women's Hospital Saarland, Homburg, Germany.""}, {'ForeName': 'Sibil', 'Initials': 'S', 'LastName': 'Tschudin', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital Basel, Basel, Switzerland.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez136']
972,31318231,SMART longitudinal analysis: A tutorial for using repeated outcome measures from SMART studies to compare adaptive interventions.,"In recent years, there has been increased interest in the development of adaptive interventions across various domains of health and psychological research. An adaptive intervention is a protocolized sequence of individualized treatments that seeks to address the unique and changing needs of individuals as they progress through an intervention program. The sequential, multiple assignment, randomized trial (SMART) is an experimental study design that can be used to build the empirical basis for the construction of effective adaptive interventions. A SMART involves multiple stages of randomizations; each stage of randomization is designed to address scientific questions concerning the best intervention option to employ at that point in the intervention. Several adaptive interventions are embedded in a SMART by design; many SMARTs are motivated by scientific questions that concern the comparison of these embedded adaptive interventions. Until recently, analysis methods available for the comparison of adaptive interventions were limited to end-of-study outcomes. The current article provides an accessible and comprehensive tutorial to a new methodology for using repeated outcome data from SMART studies to compare adaptive interventions. We discuss how existing methods for comparing adaptive interventions in terms of end-of-study outcome data from a SMART can be extended for use with longitudinal outcome data. We also highlight the scientific utility of using longitudinal data from a SMART to compare adaptive interventions. A SMART study aiming to develop an adaptive intervention to engage alcohol- and cocaine-dependent individuals in treatment is used to demonstrate the application of this new methodology. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"In recent years, there has been increased interest in the development of adaptive interventions across various domains of health and psychological research.",[],[],[],[],[],[],2019.0,0.0344952,"In recent years, there has been increased interest in the development of adaptive interventions across various domains of health and psychological research.","[{'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research.'}, {'ForeName': 'Jamie R T', 'Initials': 'JRT', 'LastName': 'Yap', 'Affiliation': 'Institute for Social Research.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'McKay', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Freiheit', 'Affiliation': 'Institute for Social Research.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Dziak', 'Affiliation': 'Methodology Center.'}]",Psychological methods,['10.1037/met0000219']
973,20821333,[PrefCheck: patient-centered treatment planning with older multimorbid patients. Method and design].,"BACKGROUND


The aim of the study is to develop and test a consultation guide (PrefCheck) for general practitioners (GPs) based on geriatric assessment results. The goal of the consultation guide is to facilitate priority setting and treatment planning based on building a partnership with geriatric patients with multiple chronic diseases.
METHODS AND AIMS


The mixed method study consists of three complementary parts: (A) health and treatment priorities of 32 patients and their 8 GPs are determined and explored on the basis of assessment results. These findings lead to the development of the consultation guide, which is subsequently tested in a cluster-randomized controlled intervention study (B) with 40 GPs and 320 patients. The aim of this study is to assess whether PrefCheck results in improved agreement in the number of health and treatment priorities between patients and their doctors. The study concludes with an evaluation study (C) with 5 GPs and 15 patients.
CONCLUSIONS


Results will be presented in a future publication. In particular it will be demonstrated whether the consultation guide can strengthen the position of older patients in the doctor-patient relationship, increase the level of information on both sides, and contribute to a shared and holistic treatment planning.",2010,"In particular it will be demonstrated whether the consultation guide can strengthen the position of older patients in the doctor-patient relationship, increase the level of information on both sides, and contribute to a shared and holistic treatment planning.","['older multimorbid patients', 'patients and their doctors', 'geriatric patients with multiple chronic diseases']",[],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]",[],[],,0.0300331,"In particular it will be demonstrated whether the consultation guide can strengthen the position of older patients in the doctor-patient relationship, increase the level of information on both sides, and contribute to a shared and holistic treatment planning.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Voigt', 'Affiliation': 'Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Carl-Neuberg-Str. 1, 30625 Hannover. voigt.isabel@mh-hannover.de'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wrede', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Diederichs-Egidi', 'Affiliation': ''}, {'ForeName': 'M-L', 'Initials': 'ML', 'LastName': 'Dierks', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hummers-Pradier', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Junius-Walker', 'Affiliation': ''}]",Zeitschrift fur Gerontologie und Geriatrie,['10.1007/s00391-010-0112-y']
974,31526207,Effects of ketamine in patients with treatment-refractory generalized anxiety and social anxiety disorders: Exploratory double-blind psychoactive-controlled replication study.,"BACKGROUND


We previously reported that ketamine has anxiolytic effects in patients with treatment-resistant generalized anxiety and social anxiety disorders.
AIMS


The purpose of this study was to replicate our earlier report about ketamine's anxiolytic activity, using a more robust study design.
METHODS


This was a double-blind, psychoactive-controlled ascending dose study in 12 patients with treatment-resistant generalized anxiety and social anxiety disorders who were not currently depressed. Ascending doses of ketamine (0.25, 0.5, 1 mg/kg) were administered at weekly intervals, and midazolam 0.01 mg/kg, the control, was randomly inserted into the ketamine dose sequence. Assessments included ratings of anxiety and dissociation, safety and tolerability, and blood samples for ketamine pharmacokinetics and BDNF concentrations.
RESULTS


Improvements in anxiety ratings occurred within an hour of ketamine dosing, and persisted for up to 1 week. A dose-response profile was noted for anxiolytic effects, dissociative side effects, and changes in blood pressure and heart rate after ketamine dosing. Midazolam had minor brief effects on anxiety ratings. Ketamine was safe and well tolerated. Ketamine pharmacokinetics were correlated with dissociation ratings. Serum BDNF concentrations declined over time and were similar for all treatments.
CONCLUSIONS


Ketamine may be a potential therapeutic option for patients with treatment-resistant generalized anxiety and social anxiety disorders.",2020,"A dose-response profile was noted for anxiolytic effects, dissociative side effects, and changes in blood pressure and heart rate after ketamine dosing.","['patients with treatment-resistant generalized anxiety and social anxiety disorders', '12 patients with treatment-resistant generalized anxiety and social anxiety disorders who were not currently depressed', 'patients with treatment-refractory generalized anxiety and social anxiety disorders']","['Midazolam', 'midazolam', 'Ketamine', 'ketamine']","['dissociation ratings', 'Serum BDNF concentrations', 'blood pressure and heart rate', 'ratings of anxiety and dissociation, safety and tolerability, and blood samples for ketamine pharmacokinetics and BDNF concentrations', 'anxiolytic effects, dissociative side effects', 'anxiety ratings', 'safe and well tolerated', 'anxiolytic effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0086168', 'cui_str': 'Dissociation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3179404', 'cui_str': 'Antianxiety Effects'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.017002,"A dose-response profile was noted for anxiolytic effects, dissociative side effects, and changes in blood pressure and heart rate after ketamine dosing.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Glue', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Neehoff', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Sabadel', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Broughton', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Le Nedelec', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Shabah', 'Initials': 'S', 'LastName': 'Shadli', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'McNaughton', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Medlicott', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119874457']
975,31529450,Does Prepregnancy Weight or Maternal BMI at Betamethasone Administration Impact Late Preterm Respiratory Morbidity?,"OBJECTIVE


We sought to determine if maternal prepregnancy body mass index (BMI) is a risk factor for neonatal respiratory morbidity and to determine if increasing BMI decreased the efficacy of betamethasone (BMZ).
STUDY DESIGN


This was a secondary analysis of the Antenatal Late Preterm Steroids trial, double-blind, randomized controlled trial involving 2,831 women between 34 0/7  and 36 5/7  weeks who received BMZ or a matching placebo. We compared the rate of neonatal respiratory morbidity among prepregnancy BMI classes in both the placebo and treatment groups. We also stratified the treatment effect by maternal BMI at the time of delivery.
RESULTS


A total of 2,822 women were identified with maternal weight recorded at delivery; 2,740 women also had self-reported prepregnancy weight available. When stratified by prepregnancy BMI class, there was no difference in neonatal respiratory morbidity in the BMZ or in placebo groups. When analyzed by BMI at delivery, there was no difference in the rate of neonatal respiratory morbidity, and BMI was not a predictor of treatment response (odds ratio = 1.00, 95% confidence interval = 0.99-1.02).
CONCLUSION


Maternal prepregnancy BMI is not associated with late preterm neonatal respiratory morbidity. Maternal obesity does not decrease the efficacy of BMZ for preventing late preterm neonatal respiratory morbidity.",2020,"When stratified by prepregnancy BMI class, there was no difference in neonatal respiratory morbidity in the BMZ or in placebo groups.","['2,822 women were identified with maternal weight recorded at delivery; 2,740 women also had self-reported prepregnancy weight available', '2,831 women between 34 0/7  and 36 5/7  weeks who received']","['placebo', 'BMZ', 'BMZ or a matching placebo', 'betamethasone (BMZ']","['Prepregnancy Weight or Maternal BMI', 'rate of neonatal respiratory morbidity', 'neonatal respiratory morbidity', 'rate of neonatal respiratory morbidity, and BMI']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}]",2831.0,0.436586,"When stratified by prepregnancy BMI class, there was no difference in neonatal respiratory morbidity in the BMZ or in placebo groups.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Bicocca', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Blackwell', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas.'}]",American journal of perinatology,['10.1055/s-0039-1696644']
976,31529406,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept in a Randomized Trial in Healthy Caucasian and Japanese Subjects.","BACKGROUND AND OBJECTIVE


Atacicept is an inhibitor of the B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), and is being studied in relation to immunological disease. Currently, limited data on atacicept are available in non-Caucasian subjects. Pharmacokinetic data from earlier studies of atacicept were derived using an enzyme-linked immunosorbent assay (ELISA), which was subsequently found to have inadequacies. Hence, a new bioanalytical ELISA for total atacicept was developed and validated. We conducted this randomized, double-blind, placebo-controlled phase I study to compare the safety, tolerability, pharmacokinetics, and pharmacodynamics of atacicept in healthy Japanese and Caucasian subjects while generating pharmacokinetic data using the new ELISA.
METHODS


Japanese subjects aged ≥ 18 to ≤ 55 years (n  = 24) were randomized (1:1:1:1) to a single subcutaneous dose of atacicept 25, 75, or 150 mg or placebo. Caucasian subjects were then enrolled to match the Japanese subjects' gender, body weight (± 20%), and height (± 15%).
RESULTS


Atacicept was well tolerated and there were no clinically significant differences in treatment-emergent adverse events (TEAEs), vital signs, or laboratory parameters between the Japanese and Caucasian subjects. Most (90%) TEAEs were mild; no severe or serious TEAEs or deaths occurred. Weight-adjusted atacicept exposure was comparable between ethnicities and across doses: the Japanese/Caucasian ratio of the area under the serum concentration-time curve from time zero to the last sampling point (AUC 0-t ) was 107.21% (90% CI 93.42-123.02%) and the Japanese/Caucasian ratio of maximum serum concentration (C max ) was 95.74% (90% CI 74.26-123.43%; ANCOVA). Median time to reach C max  (t max ) was 20-60 h across all subjects. Dose-exposure relationships were comparable for the two ethnicities, with dose-normalized AUC 0-t  decreasing with increasing dose, indicating nonlinear pharmacokinetics for the doses examined. There were no statistically significant differences between ethnicities in the pharmacokinetics-dose relationship. Some transient dose-related decreases in mean serum immunoglobulin (Ig)A and IgM, but not IgG, were observed after atacicept administration. There were small transient increases in peripheral B cell numbers in the first 4 days after dosing that were larger with atacicept than with placebo, with no apparent dose relationship. No anti-atacicept antibodies were detected.
CONCLUSION


The safety, pharmacokinetic, and pharmacodynamic profiles of atacicept in healthy Japanese subjects were comparable to those in healthy Caucasian subjects. EudraCT-ID: 2013-002703-34.",2020,"RESULTS


Atacicept was well tolerated and there were no clinically significant differences in treatment-emergent adverse events (TEAEs), vital signs, or laboratory parameters between the Japanese and Caucasian subjects.","['healthy Japanese and Caucasian subjects', 'healthy Caucasian subjects', 'non-Caucasian subjects', ""Caucasian subjects were then enrolled to match the Japanese subjects' gender, body weight (±\u200920%), and height (±\u200915"", 'Healthy Caucasian and Japanese Subjects', 'healthy Japanese subjects', 'Japanese subjects aged\u2009≥\u200918 to\u2009≤\u200955\xa0years (n\u2009 =\u200924']","['placebo', 'atacicept 25, 75, or 150\xa0mg or placebo']","['Median time to reach C max  (t max ', 'mean serum immunoglobulin (Ig)A and IgM', 'tolerated', 'peripheral B cell numbers', 'Weight-adjusted atacicept exposure', 'safety, tolerability, pharmacokinetics, and pharmacodynamics of atacicept', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Atacicept', 'mild; no severe or serious TEAEs or deaths', 'treatment-emergent adverse events (TEAEs), vital signs, or laboratory parameters', 'safety, pharmacokinetic, and pharmacodynamic profiles of atacicept', 'Japanese/Caucasian ratio of maximum serum concentration (C max ']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2351058', 'cui_str': 'Atacicept'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0858451', 'cui_str': 'Serum immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C2351058', 'cui_str': 'Atacicept'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0898679,"RESULTS


Atacicept was well tolerated and there were no clinically significant differences in treatment-emergent adverse events (TEAEs), vital signs, or laboratory parameters between the Japanese and Caucasian subjects.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Willen', 'Affiliation': 'Merck KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Uhl', 'Affiliation': 'Merck KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wolna', 'Affiliation': 'Merck KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany.'}, {'ForeName': 'Orestis', 'Initials': 'O', 'LastName': 'Papasouliotis', 'Affiliation': 'Merck Institute for Pharmacometrics (An Affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.'}, {'ForeName': 'Özkan', 'Initials': 'Ö', 'LastName': 'Yalkinoglu', 'Affiliation': 'Merck KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany. oezkan.yalkinoglu@merckgroup.com.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-019-00575-7']
977,31801620,Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies.,"BACKGROUND


Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies.
METHOD


Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3-6) to full resolution (FR), stable (similar or reduction of EC), or worse (EC > baseline). Efficacy outcomes (ACR, PASI, HAQ-DI, SF-36 PCS, and DAS28-CRP) were assessed in patients with or without baseline enthesitis. Results are reported for secukinumab 300 and 150 mg in the overall population and by prior TNFi treatment.
RESULTS


A total of 65% (466/712) of patients had baseline enthesitis. In the overall population, FR was achieved as early as week 16 in 65% (300 mg) and 56% (150 mg) versus 44% (placebo) patients, with further improvements to 91% (300 mg) and 88% (150 mg) at week 104. The majority (89%) of patients without enthesitis at baseline maintained this status at week 104. Median days to resolution of EC were shorter with secukinumab 300 and 150 mg versus placebo (57 and 85 vs 167 days, respectively). In patients with EC of 1 or 2, shift analysis from baseline to week 24 showed that more patients achieved FR with secukinumab 300 mg and 150 mg versus placebo, whereas no difference between secukinumab and placebo was shown in the more severe patients with EC of 3-6. Increases in proportions of patients with FR were observed with secukinumab irrespective of the severity of EC from baseline to week 104. Improvements in efficacy outcomes were similar in patients with or without enthesitis treated with secukinumab 300 mg.
CONCLUSION


Secukinumab provided early and sustained resolution of enthesitis in patients with PsA over 2 years. Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis.
TRIAL REGISTRATION


FUTURE 2: ClinicalTrials.gov, NCT01752634 (date of study registration: December 19, 2012), and EudraCT, 2012-004439-22 (date of study registration: December 12, 2012) FUTURE 3: ClinicalTrials.gov, NCT01989468 (date of study registration: November 21, 2013), and EudraCT, 2013-004002-25 (date of study registration: December 17, 2013).",2019,"Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis.
","['Assessments of enthesitis through week 104 used the Leeds Enthesitis Index', 'psoriatic arthritis', 'patients with PsA', ' December 19, 2012), and EudraCT, 2012-004439-22 (date of study registration: December 12, 2012) FUTURE 3: ClinicalTrials.gov, NCT01989468 (date of study registration: November 21, 2013), and EudraCT, 2013-004002-25 (date of study registration']","['placebo', 'secukinumab']","['Efficacy outcomes (ACR, PASI, HAQ-DI, SF-36 PCS, and DAS28-CRP', 'efficacy outcomes', 'overall efficacy', 'Median days to resolution of EC', 'resolution of enthesitis count (EC\u2009=\u20090), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3-6) to full resolution (FR), stable (similar or reduction of EC']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis (disorder)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0451148', 'cui_str': 'Enthesitis index (assessment scale)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis (disorder)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.241508,"Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis.
","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Windmill Road, Oxford, OX3 7LD, UK. laura.coates@ndorms.ox.ac.uk.'}, {'ForeName': 'Johan K', 'Initials': 'JK', 'LastName': 'Wallman', 'Affiliation': 'Department of Clinical Sciences Lund, Rheumatology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'McGonagle', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Georg A', 'Initials': 'GA', 'LastName': 'Schett', 'Affiliation': 'University of Erlangen-Nuremberg, Erlangen, Germany.'}, {'ForeName': 'Iain B', 'Initials': 'IB', 'LastName': 'McInnes', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Centre and University of Washington, Seattle, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Rasouliyan', 'Affiliation': 'RTI Health Solutions, Barcelona, Spain.'}, {'ForeName': 'Erhard', 'Initials': 'E', 'LastName': 'Quebe-Fehling', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Asquith', 'Affiliation': 'Novartis Pharmaceuticals UK Ltd., Camberley, UK.'}, {'ForeName': 'Andreas E R', 'Initials': 'AER', 'LastName': 'Fasth', 'Affiliation': 'Novartis Sverige AB, Täby, Sweden.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Gaillez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Arthritis research & therapy,['10.1186/s13075-019-2055-z']
978,31334793,Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial.,"Importance


Patients with active rheumatoid arthritis (RA) despite treatment with biologic disease-modifying antirheumatic drug (bDMARD) therapy need treatment options.
Objective


To evaluate the effects of filgotinib vs placebo on the signs and symptoms of RA in a treatment-refractory population.
Design, Setting, and Participants


A 24-week, randomized, placebo-controlled, multinational phase 3 trial conducted from July 2016 to June 2018 at 114 sites internationally, randomizing 449 adult patients (and treating 448) with moderately to severely active RA and inadequate response/intolerance to 1 or more prior bDMARDs.
Interventions


Filgotinib, 200 mg (n = 148); filgotinib, 100 mg (n = 153); or placebo (n = 148) once daily; patients continued concomitant stable conventional synthetic DMARDs (csDMARDs).
Main Outcomes and Measures


The primary end point was the proportion of patients who achieved 20% improvement in the American College of Rheumatology criteria (ACR20) at week 12. Secondary outcomes included week 12 assessments of low disease activity (disease activity score in 28 joints-C-reactive protein [DAS28-CRP] ≤3.2) and change in Health Assessment Questionnaire-Disability Index, 36-Item Short-Form Health Survey Physical Component, and Functional Assessment of Chronic Illness Therapy-Fatigue scores, as well as week 24 assessment of remission (DAS28-CRP <2.6) and adverse events.
Results


Among 448 patients who were treated (mean [SD] age, 56 [12] years; 360 women [80.4%]; mean [SD] DAS28-CRP score, 5.9 [0.96]; 105 [23.4%] with ≥3 prior bDMARDs), 381 (85%) completed the study. At week 12, more patients receiving filgotinib, 200 mg (66.0%) or 100 mg (57.5%), achieved ACR20 response (placebo, 31.1%; difference vs placebo: 34.9% [95% CI, 23.5%-46.3%] and 26.4% [95% CI, 15.0%-37.9%], respectively; both P < .001), including among patients with prior exposure to 3 or more bDMARDs (70.3%, 58.8%, and 17.6%, respectively; difference vs placebo: 52.6% [95% CI, 30.3%-75.0%] for filgotinib, 200 mg, and 41.2% [95% CI, 17.3%-65.0%] for filgotinib, 100 mg; both P < .001). The most common adverse events were nasopharyngitis (10.2%) for filgotinib, 200 mg; headache, nasopharyngitis, and upper respiratory infection (5.9% each) for filgotinib, 100 mg; and RA (6.1%) for placebo. Four uncomplicated herpes zoster cases and 1 retinal vein occlusion were reported with filgotinib; there were no opportunistic infections, active tuberculosis, malignancies, gastrointestinal perforations, or deaths.
Conclusions and Relevance


Among patients with active RA who had an inadequate response or intolerance to 1 or more bDMARDs, filgotinib, 100 mg daily or 200 mg daily, compared with placebo resulted in a significantly greater proportion achieving a clinical response at week 12. However, further research is needed to assess longer-term efficacy and safety.
Trial Registration


ClinicalTrials.gov Identifier: NCT02873936.",2019,"The most common adverse events were nasopharyngitis (10.2%) for filgotinib, 200 mg; headache, nasopharyngitis, and upper respiratory infection (5.9% each) for filgotinib, 100 mg; and RA (6.1%) for placebo.","['patients with active RA who had an inadequate response or intolerance', '448 patients who were treated (mean [SD] age, 56 [12] years', ' 360 women [80.4%]; mean [SD] DAS28-CRP score, 5.9 [0.96]; 105 [23.4%] with ≥3 prior bDMARDs), 381 (85%) completed the study', 'Importance\n\n\nPatients with active rheumatoid arthritis (RA) despite treatment with biologic disease-modifying antirheumatic drug (bDMARD) therapy need treatment options', 'July 2016 to June 2018 at 114 sites internationally, randomizing 449 adult patients (and treating 448) with moderately to severely active RA and inadequate response/intolerance to 1 or more prior bDMARDs', 'Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy']","['placebo (n\u2009=\u2009148) once daily; patients continued concomitant stable conventional synthetic DMARDs (csDMARDs', 'Filgotinib vs Placebo', 'filgotinib vs placebo', 'placebo']","['bDMARDs', 'achieved ACR20 response', 'adverse events', 'opportunistic infections, active tuberculosis, malignancies, gastrointestinal perforations, or deaths', 'proportion of patients who achieved 20% improvement in the American College of Rheumatology criteria (ACR20', 'low disease activity (disease activity score in 28 joints-C-reactive protein [DAS28-CRP] ≤3.2) and change in Health Assessment Questionnaire-Disability Index, 36-Item Short-Form Health Survey Physical Component, and Functional Assessment of Chronic Illness Therapy-Fatigue scores, as well as week 24 assessment of remission', 'retinal vein occlusion', 'clinical response', 'headache, nasopharyngitis, and upper respiratory infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517655', 'cui_str': '23.4 (qualifier value)'}, {'cui': 'C4708787', 'cui_str': '381 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C0151332', 'cui_str': 'Active tuberculosis (disorder)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0035328', 'cui_str': 'Retinal Vein Occlusion'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",449.0,0.596729,"The most common adverse events were nasopharyngitis (10.2%) for filgotinib, 200 mg; headache, nasopharyngitis, and upper respiratory infection (5.9% each) for filgotinib, 100 mg; and RA (6.1%) for placebo.","[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University, Stanford, California.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kalunian', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Neelufar', 'Initials': 'N', 'LastName': 'Mozaffarian', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Bartok', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Matzkies', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Gilead Sciences Inc, Foster City, California.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare, North Shields, United Kingdom.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Keio University School of Medicine, Tokyo, Japan.'}]",JAMA,['10.1001/jama.2019.9055']
979,31324126,Use of eggshell-derived nano-hydroxyapatite as novel bone graft substitute-A randomized controlled clinical study.,,2019,,[],['eggshell-derived nano-hydroxyapatite'],[],[],"[{'cui': 'C4521537', 'cui_str': 'Eggshell'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}]",[],,0.0540946,,"[{'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Kattimani', 'Affiliation': '1 Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Guntur, India.'}, {'ForeName': 'Krishna Prasad', 'Initials': 'KP', 'LastName': 'Lingamaneni', 'Affiliation': '1 Department of Oral and Maxillofacial Surgery, Sibar Institute of Dental Sciences, Guntur, India.'}, {'ForeName': 'Samatha', 'Initials': 'S', 'LastName': 'Yalamanchili', 'Affiliation': '2 Department of Oral Medicine and Radiology, Sibar Institute of Dental Sciences, Guntur, India.'}, {'ForeName': 'Muralidhar', 'Initials': 'M', 'LastName': 'Mupparapu', 'Affiliation': '3 Department of Oral Medicine, University of Pennsylvania School of Dental Medicine, Philadelphia, PA, USA.'}]",Journal of biomaterials applications,['10.1177/0885328219863311']
980,19732888,Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial.,"OBJECTIVE


To compare the effect of letrozole with combined metformin and clomiphene citrate (CC) for ovulation induction in CC-resistant women with polycystic ovary syndrome (PCOS).
DESIGN


A randomized controlled trial.
SETTING


University teaching hospital and a private practice setting.
PATIENT(S)


Two hundred fifty anovulatory women (582 cycles) with CC-resistant PCOS.
INTERVENTION(S)


Patients received 2.5 mg of letrozole daily (123 patients, 285 cycles) or combined metformin-CC (127 patients, 297 cycles) for three treatment cycles.
MAIN OUTCOME MEASURE(S)


Ovulation rate, number of follicles, serum E(2), serum P, endometrial thickness, pregnancy, and miscarriage rates.
RESULT(S)


Ovulation occurred in 185/285 cycles (64.9%) in the letrozole group versus 207/297 cycles (69.6%) in the combined metformin-CC group, without statistically significant difference. The total number of follicles was significantly more in the combined metformin-CC group (4.4+/-0.4 vs. 6.8+/-0.3). A nonsignificant increase in endometrial thickness on the day of hCG administration was observed in the letrozole group (9.5+/-0.2 mm vs. 9.1+/-0.1 mm). No statistically significant difference regarding the pregnancy rate (PR) was observed between both groups (14.7% vs. 14.4%).
CONCLUSION(S)


Letrozole and combined metformin-CC are equally effective for inducing ovulation and achieving pregnancy in patients with CC-resistant PCOS.",2010,"No statistically significant difference regarding the pregnancy rate (PR) was observed between both groups (14.7% vs. 14.4%).
","['CC-resistant women with polycystic ovary syndrome (PCOS', 'University teaching hospital and a private practice setting', 'clomiphene-resistant women with polycystic ovary syndrome', 'Two hundred fifty anovulatory women (582 cycles) with CC-resistant PCOS', 'patients with CC-resistant PCOS']","['letrozole with combined metformin and clomiphene citrate (CC', 'Letrozole', 'Letrozole and combined metformin-CC', 'letrozole', 'metformin and clomiphene citrate', 'combined metformin-CC']","['endometrial thickness', 'Ovulation rate, number of follicles, serum E(2), serum P, endometrial thickness, pregnancy, and miscarriage rates', 'Ovulation', 'pregnancy rate (PR', 'total number of follicles']","[{'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0429468', 'cui_str': 'Anovulatory (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.127884,"No statistically significant difference regarding the pregnancy rate (PR) was observed between both groups (14.7% vs. 14.4%).
","[{'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Abu Hashim', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: hatem_ah@hotmail.com.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokeir', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2009.07.985']
981,32432388,"Lorecivivint, a Novel Intraarticular CDC-Like Kinase 2 and Dual-Specificity Tyrosine Phosphorylation-Regulated Kinase 1A Inhibitor and Wnt Pathway Modulator for the Treatment of Knee Osteoarthritis: A Phase II Randomized Trial.","OBJECTIVE


To assess the safety and efficacy of a novel Wnt pathway modulator, lorecivivint (SM04690), for treating pain and inhibiting structural progression in moderately to severely symptomatic knee osteoarthritis (OA).
METHODS


Subjects in this 52-week, phase IIa, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial received a single 2-ml intraarticular injection of lorecivivint (dose of 0.03 mg, 0.07 mg, or 0.23 mg) or placebo. Efficacy was assessed based on change from baseline on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score subscales for pain and function (scale 0-100 for each) and change from baseline in the radiographic medial joint space width (JSW). Baseline-adjusted analysis of covariance with multiple imputation was performed separately to evaluate efficacy. This proof-of-concept study evaluated the intent-to-treat population as well as a prespecified group of subjects with unilateral symptoms of knee OA (designated UNI) and an additional post hoc subgroup of subjects with unilateral symptoms but without widespread pain (designated UNI WP-).
RESULTS


In this trial, 455 subjects were randomized to a treatment group. The primary end point, significant improvement in the WOMAC pain score compared with placebo at week 13, was not met by any lorecivivint dose group (mean ± SD change from baseline, -23.3 ± 2.2 in the 0.03 mg group, -23.5 ± 2.1 in the 0.07 mg group, -21.3 ± 2.2 in the 0.23 mg group, and -22.1 ± 2.1 in the placebo group; each P > 0.05 versus placebo). All groups (including placebo) demonstrated clinically meaningful (≥20-point) improvements from baseline in the WOMAC pain score. The durability of response was evaluated through week 52. In the prespecified UNI group and post hoc UNI WP- group at week 52, treatment with 0.07 mg lorecivivint significantly improved the WOMAC pain score (between-group difference versus placebo, -8.73, 95% confidence interval [95% CI] -17.44, -0.03 [P = 0.049] and -11.21, 95% CI -20.99, -1.43 [P = 0.025], respectively) and WOMAC function score (between-group difference versus placebo, -10.26, 95% CI -19.82, -0.69 [P = 0.036] and -13.38, 95% CI -24.33, -2.43 [P = 0.017], respectively). Relative to baseline, the mean change in the medial JSW at week 52 was -0.04 mm in the 0.03 mg cohort, -0.09 mm in the 0.07 mg cohort, -0.16 mm in the 0.23 mg cohort, and -0.14 mm in the placebo cohort; no treatment group achieved a significant change in medial JSW compared with placebo at week 52. In both unilateral symptom subgroups, the 0.07 mg lorecivivint dose significantly increased medial JSW compared with placebo at week 52 (medial JSW 0.39 mm, 95% CI 0.06, 0.72 in the UNI group [P = 0.021] and 0.42 mm, 95% CI 0.04, 0.80 in the UNI WP- group [P = 0.032]). Changes observed in the 0.03 mg and 0.23 mg dose groups were not significantly different from those in the placebo group for any of these measures. Lorecivivint appeared safe and well tolerated.
CONCLUSION


This phase IIa, proof-of-concept trial in patients with symptomatic knee OA did not meet its primary end point. Nevertheless, the study identified a target population in whom to evaluate the potential efficacy of lorecivivint for the treatment of knee OA.",2020,"The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05).","['Subjects', 'Four hundred fifty-five subjects were randomized', 'Knee Osteoarthritis', 'subjects with unilateral symptoms (UNI) and an additional post hoc subgroup of unilateral symptomatic subjects without widespread pain (UNI WP', 'moderate-to-severe symptomatic knee osteoarthritis (OA']","['placebo (PBO)-controlled', 'novel Wnt pathway modulator lorecivivint (SM04690']","['mean change in mJSW', 'mJSW', 'durability of response', 'WOMAC Pain [0-100] and WOMAC Function [0-100] subscales and radiographic medial joint space width (mJSW', 'safety and efficacy', 'Efficacy', 'safe and well tolerated', 'WOMAC Function', 'WOMAC Pain']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1520113', 'cui_str': 'Wnt Pathway'}, {'cui': 'C4706114', 'cui_str': 'SM04690'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",455.0,0.138937,"The primary endpoint, improvement in WOMAC Pain compared with PBO at Week 13, was not met by any dose group (change from baseline, 0.03 mg, -23.3±2.2; 0.07 mg, -23.5±2.1; 0.23 mg, -21.3±2.2; PBO, -22.1±2.1; all P>0.05).","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Yazici', 'Affiliation': 'Samumed LLC, San Diego, California.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'McAlindon', 'Affiliation': 'Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Gibofsky', 'Affiliation': 'Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'UC Davis Medical School, Burlingame, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Clauw', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bergfeld', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Swearingen', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'DiFrancesco', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Simsek', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Jeyanesh', 'Initials': 'J', 'LastName': 'Tambiah', 'Affiliation': 'Samumed, LLC, San Diego, California.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41315']
982,31518174,Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial.,"PURPOSE


The addition of ovarian function suppression (OFS) for 5 years to tamoxifen (TAM) for treatment of premenopausal patients with breast cancer after completion of chemotherapy has beneficial effects on disease-free survival (DFS). This study evaluated the efficacy of adding 2 years of OFS to TAM in patients with hormone receptor-positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy.
PATIENTS AND METHODS


We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor-positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy. Ovarian function was assessed every 6 months for 2 years since enrollment on the basis of follicular-stimulating hormone levels and vaginal bleeding history. If ovarian function was confirmed to be premenopausal at each visit, the patient was randomly assigned to complete 5 years of TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS) group. DFS was defined from the time of enrollment to the time of the first event.
RESULTS


A total of 1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis. The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97;  P  = .033). The estimated 5-year overall survival rate was 99.4% in the TAM + OFS group and 97.8% in the TAM-only group (hazard ratio, 0.31; 95% CI, 0.10 to 0.94;  P  = .029).
CONCLUSION


The addition of 2 years of OFS to TAM significantly improved DFS compared with TAM alone in patients who remained premenopausal or resumed ovarian function after chemotherapy.",2020,"The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97;  P  = .033).","['Premenopausal Breast Cancer', 'patients with hormone receptor-positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy', 'patients who remained premenopausal or resumed ovarian function after chemotherapy', 'We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor-positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy', '1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis', 'premenopausal patients with breast cancer after completion of']","['ovarian function suppression (OFS', 'TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS', 'TAM + OFS', 'OFS to TAM', 'chemotherapy', 'TAM', 'Tamoxifen', 'tamoxifen (TAM']","['disease-free survival (DFS', '5-year DFS rate', '5-year overall survival rate', 'DFS', 'Ovarian function']","[{'cui': 'C0741682', 'cui_str': 'Premenopausal breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0016712', 'cui_str': ""Freund's Adjuvant""}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0031843', 'cui_str': 'function'}]",1293.0,0.181147,"The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97;  P  = .033).","[{'ForeName': 'Hyun-Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Byeong-Woo', 'Initials': 'BW', 'LastName': 'Park', 'Affiliation': 'Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital Seoul, Republic of Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Ajou University, Suwon, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kang', 'Affiliation': ""Cheil General Hospital and Women's Healthcare Center, Seoul, Republic of Korea.""}, {'ForeName': 'Soo-Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Yeungnam University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'Gangnam Severance Hospital, Seoul, Republic or Korea.'}, {'ForeName': 'Se-Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Soonchunhyang University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Lee Su', 'Initials': 'LS', 'LastName': 'Kim', 'Affiliation': 'Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Byung-In', 'Initials': 'BI', 'LastName': 'Moon', 'Affiliation': ""Ewha Woman's University Mokdong Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Min Hyuk', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Soonchunhyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Inje University Busan Paik Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Chanheun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hoo', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Geumhee', 'Initials': 'G', 'LastName': 'Gwak', 'Affiliation': 'Inje University Sanggye Paik Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jeryong', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Jin', 'Affiliation': 'Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Se-Hwan', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Ajou University, Suwon, Republic of Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Hur', 'Affiliation': 'Inha University, Incheon, Republic of Korea.'}, {'ForeName': 'Woo Chul', 'Initials': 'WC', 'LastName': 'Noh', 'Affiliation': 'Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00126']
983,18692823,Clomiphene citrate or aromatase inhibitors for superovulation in women with unexplained infertility undergoing intrauterine insemination: a prospective randomized trial.,"OBJECTIVE


To compare clomiphene citrate (CC) and letrozole used for superovulation before intrauterine insemination (IUI) in unexplained infertility.
DESIGN


Prospective randomized trial.
SETTING


A university teaching hospital and a private practice setting.
PATIENT(S)


Four hundred and twelve infertile women with unexplained infertility.
INTERVENTION(S)


Patients were randomized to treatment with 100 mg of CC daily (207 patients, 404 cycles) or 5 mg of letrozole daily (205 patients, 400 cycles) for 5 days starting on day 3 of menses. The IUI was done 36 +/- 4 hours after human chorionic gonadotropin (hCG) injection.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum estradiol level, serum progesterone level, endometrial thickness, and pregnancy and miscarriage rates.
RESULT(S)


The total number of follicles during stimulation was statistically significantly greater in the CC group (3.1 +/- 0.36 vs. 1.6 +/- 0.41). There was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hCG administration. Serum E(2) and progesterone concentrations were statistically significantly higher in the CC group. The days to hCG injection were similar in both groups. Pregnancy occurred in 73 out of 205 patients (400 cycles) in the letrozole group (35.6% and 18.2%, respectively) and 78 out of 207 patients (404 cycles) (37.6% and 19.3%, respectively) in the CC group; the differences were not statistically significant. Two twin pregnancies occurred in the CC group.
CONCLUSION(S)


This study found no superiority between letrozole and CC for inducing ovulation in women with unexplained infertility before IUI.",2009,There was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hCG administration.,"['women with unexplained infertility before IUI', 'women with unexplained infertility undergoing intrauterine insemination', 'Four hundred and twelve infertile women with unexplained infertility', 'A university teaching hospital and a private practice setting']","['clomiphene citrate (CC) and letrozole', 'human chorionic gonadotropin (hCG) injection', 'letrozole and CC', 'letrozole', 'Clomiphene citrate or aromatase inhibitors']","['Pregnancy', 'pretreatment endometrial thickness', 'total number of follicles during stimulation', 'Number of follicles, serum estradiol level, serum progesterone level, endometrial thickness, and pregnancy and miscarriage rates', 'Serum E(2) and progesterone concentrations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility (finding)'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination (procedure)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}]","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0428410', 'cui_str': 'Serum progesterone measurement'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",412.0,0.07962,There was no statistically significant difference in pretreatment endometrial thickness between the two groups or endometrial thickness at the time of hCG administration.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Elnashar', 'Affiliation': 'Department of Obstetrics and Gynecology, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Totongy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2008.06.013']
984,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance


Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands.
Objective


To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
Design, Setting, and Participants


Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018.
Interventions


The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform.
Main Outcomes and Measures


Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period.
Results


One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively.
Conclusions and Relevance


In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs.
Trial Registration


ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients.
","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011']
985,31473291,A Randomized Controlled Trial of Interventions for Growth Suppression in Children With Attention-Deficit/Hyperactivity Disorder Treated With Central Nervous System Stimulants.,"OBJECTIVE


To examine the impact of central nervous system (CNS) stimulants on the growth of children with attention-deficit/hyperactivity disorder (ADHD), and to assess the efficacy and feasibility of weight recovery interventions on growth.
METHOD


A total of 230 children aged 5 to 12 years with ADHD with no history of chronic CNS stimulant use were randomly assigned to receive daily CNS stimulants (78%, primarily OROS-methylphenidate [OROS-MPH]) or behavioral treatment (22%) for 30 months. After 6 months, children evidencing a decline in body mass index (BMI) of >0.5 z-units were randomized to 1 of 3 weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication; drug holidays (DH) with medication limited to school days; or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication.
RESULTS


Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p values <.01). Adherence to CS and DH during WRT was high, with significant increases in daily caloric intake and decreases in weekly medication exposure (p values <.05). Across all WRT participants (n = 71), weight velocity increased significantly after WRT randomization (β 2  = 0.271, SE = 0.027, p < .001).When analyzed by what parents did (versus what they were assigned to), CS (p < .01) and DH (p < .05) increased weight velocity more than MON. No increase in height velocity was seen after randomization to any WRT. Over the entire study, WRT participants declined in standardized weight (-0.44 z-units) and height (-0.20 z-units).
CONCLUSION


Drug holidays, caloric supplementation, and increased monitoring all led to increased weight velocity in children taking CNS stimulants, but none led to increased height velocity.
CLINICAL TRIAL REGISTRATION INFORMATION


Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth; https://clinicaltrials.gov/; NCT01109849.",2019,"Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p's<.01).","['children with attention-deficit/hyperactivity disorder (ADHD', '230 children ages 5-12 with ADHD with no history of chronic CNS stimulant usage', 'Children With Attention-Deficit/Hyperactivity Disorder']","['daily CNS stimulants', 'weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication, drug holidays (DH) with medication limited to school days, or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication', 'central nervous system (CNS) stimulants', 'Central Nervous System Stimulants', 'primarily OROS-Methylphenidate [OROS-MPH]) or behavioral treatment']","['weight velocity', 'body mass index (BMI', ""standardized weight and height (p's<.01"", 'height velocity', 'daily caloric intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0019843', 'cui_str': 'Holidays'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3544299', 'cui_str': 'Caloric supplementation'}, {'cui': 'C0050286', 'cui_str': 'A 150 (plastic)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0002763', 'cui_str': 'Central Stimulants'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}]","[{'cui': 'C0455808', 'cui_str': 'Weight velocity (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",230.0,0.183562,"Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p's<.01).","[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'Penn State College of Medicine, Hershey, PA. Electronic address: jwaxmonsky@pennstatehealth.psu.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Arizona State University, Tempe.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Campa', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Waschbusch', 'Affiliation': 'Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Marshall', 'Affiliation': 'Herbert Wertheim College of Medicine, Florida International University, Miami.'}, {'ForeName': 'Lysett', 'Initials': 'L', 'LastName': 'Babocsai', 'Affiliation': 'University of Heidelberg, Germany.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Humphery', 'Affiliation': 'Herbert Wertheim College of Medicine, Florida International University, Miami.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gnagy', 'Affiliation': 'Florida International University, Miami.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': 'School of Medicine, University of California, Irvine.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Hanć', 'Affiliation': 'Adam Mickiewicz University, Poznan, Poland.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Fallahazad', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Florida International University, Miami.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.08.472']
986,31791386,"Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs.","BACKGROUND


Patient-reported outcomes (PROs) are important when evaluating treatment benefits in rheumatoid arthritis (RA). We compared upadacitinib, an oral, selective JAK-1 inhibitor, with placebo to assess clinically meaningful improvements in PROs in patients with RA who have had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR).
METHODS


PRO responses between upadacitinib 15 mg or 30 mg and placebo were evaluated at week 12 from the SELECT-BEYOND trial. Improvement was determined by measuring Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning (AM) stiffness, and Insomnia Severity Index (ISI). Least squares mean changes and percentage of patients reporting improvements ≥ minimum clinically important differences (MCID) and scores greater than or equal to normative values were determined. The number needed to treat (NNT) to achieve clinically meaningful improvements was calculated.
RESULTS


In 498 patients, both upadacitinib doses resulted in statistically significant changes from baseline versus placebo in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity. Compared with placebo, more upadacitinib-treated patients reported improvements ≥ MCID in PtGA, pain, HAQ-DI, SF-36 PCS, 7 of 8 SF-36 domains (15 mg), 5 of 8 SF-36 domains (30 mg), AM stiffness duration and severity, and ISI (30 mg) and scores ≥ normative values in HAQ-DI and SF-36 domains. Across most PROs, NNTs to achieve MCID with upadacitinib ranged from 4 to 7 patients.
CONCLUSIONS


In bDMARD-IR RA patients, upadacitinib (15 mg or 30 mg) improved multiple aspects of quality of life, and more patients reached clinically meaningful improvements approaching normative values compared with placebo.
TRIAL REGISTRATION


The trial is registered with ClinicalTrials.gov (NCT02706847), registered 6 March 2016.",2019,"In 498 patients, both upadacitinib doses resulted in statistically significant changes from baseline versus placebo in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity.","['patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs', 'patients with RA who have had inadequate responses to biologic disease-modifying antirheumatic drugs (bDMARD-IR']","['placebo', 'upadacitinib 15\u2009mg or 30\u2009mg and placebo', 'upadacitinib']","['multiple aspects of quality of life', 'PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS', 'Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Short Form-36 Health Survey (SF-36), duration and severity of morning (AM) stiffness, and Insomnia Severity Index (ISI', 'AM stiffness duration and severity, and ISI', 'improvements ≥ MCID in PtGA, pain, HAQ-DI, SF-36 PCS', 'AM stiffness duration and severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}]",498.0,0.0800182,"In 498 patients, both upadacitinib doses resulted in statistically significant changes from baseline versus placebo in PtGA, pain, HAQ-DI, SF-36 Physical Component Summary (PCS), 7 of 8 SF-36 domains (15 mg), 6 of 8 SF-36 domains (30 mg), and AM stiffness duration and severity.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, 306 Ramona Road, Portola Valley, CA, 94028, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schiff', 'Affiliation': 'University of Colorado School of Medicine, Denver, CO, 80045, USA.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Tundia', 'Affiliation': 'AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA. namita.tundia@abbvie.com.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Meerwein', 'Affiliation': 'AbbVie Deutschland GmbH & Co., KG, Mainzer Strasse 81, 65189, Wiesbaden, Germany.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Ganguli', 'Affiliation': 'AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Fuldeore', 'Affiliation': 'AbbVie Inc., 1 North Waukegan Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Analysis Group Inc., 14th Floor, 111 Huntington Avenue, Boston, MA, 02199, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': ""University of Western Ontario, St. Joseph's Health Care, 268 Grosvenor Street, London, ON, N6A 4V2, Canada.""}]",Arthritis research & therapy,['10.1186/s13075-019-2059-8']
987,31825067,Matched Weight Loss Through Intermittent or Continuous Energy Restriction Does Not Lead To Compensatory Increases in Appetite and Eating Behavior in a Randomized Controlled Trial in Women with Overweight and Obesity.,"BACKGROUND


Continuous energy restriction (CER) is purported to be problematic because of reductions in fat-free mass (FFM), compensatory motivation to overeat, and weakened satiety. Intermittent energy restriction (IER) is an alternative behavioral weight loss (WL) strategy that may mitigate some of these limitations.
OBJECTIVE


The objective of the DIVA study was to compare the effects of CER and IER on appetite when the degree of WL (≥5%) is matched.
METHODS


Women with overweight/obesity (BMI 25.0-34.9 kg/m2; age 18-55 y) were recruited for this controlled-feeding RCT via CER (25% daily energy restriction) or IER (alternating ad libitum and 75% energy restriction days). Probe days were conducted at baseline and post-intervention to assess body composition, ad libitum energy intake and subjective appetite in response to a fixed-energy breakfast, and eating behavior traits. After baseline measurements, participants were allocated to CER (n = 22) or IER (n = 24). Per protocol analyses (≥5% WL within 12 wk) were conducted with use of repeated measures ANOVA.
RESULTS


Thirty of 37 completers reached ≥5% WL [CER (n = 18): 6.3 ± 0.8% in 57 ± 16 d, IER (n = 12): 6.6 ± 1.1% in 67 ± 13 d; % WL P = 0.43 and days P = 0.10]. Fat mass [-3.9 (95% CI: -4.3, -3.4) kg] and FFM [-1.3 (95% CI: -1.6, -1.0) kg] were reduced post-WL (P < 0.001), with no group differences. Self-selected meal size decreased post-WL in CER (P = 0.03) but not in IER (P = 0.19). Hunger AUC decreased post-WL (P < 0.05), with no group differences. Satiety quotient remained unchanged and was similar in both groups. Both interventions improved dietary restraint, craving control, susceptibility to hunger, and binge eating (P < 0.001).
CONCLUSIONS


Controlled ≥5% WL via CER or IER did not differentially affect changes in body composition, reductions in hunger, and improvements in eating behavior traits. This suggests that neither CER nor IER lead to compensatory adaptations in appetite in women with overweight/obesity. This trial was registered at clinicaltrials.gov as NCT03447600.",2020,Self-selected meal size decreased post-WL in CER (P = 0.03) but not in IER (P = 0.19).,"['Women with overweight/obesity (BMI 25.0-34.9\xa0kg/m2; age 18-55 y', 'women with overweight/obesity', 'Women with Overweight and Obesity']","['CER and IER', 'CER', 'Intermittent energy restriction (IER', 'IER', 'Continuous energy restriction (CER']","['Satiety quotient', 'Appetite and Eating Behavior', 'dietary restraint, craving control, susceptibility to hunger, and binge eating', 'FFM', 'Hunger AUC', 'body composition, reductions in hunger, and improvements in eating behavior traits', 'Fat mass']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0237504', 'cui_str': 'CER (body structure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.283,Self-selected meal size decreased post-WL in CER (P = 0.03) but not in IER (P = 0.19).,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Casanova', 'Affiliation': 'School of Food Science and Nutrition, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Oustric', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Turicchi', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gibbons', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hopkins', 'Affiliation': 'School of Food Science and Nutrition, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Varady', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Blundell', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS2 9JT, UK.'}]",The Journal of nutrition,['10.1093/jn/nxz296']
988,31390890,Can Nonexperimental Methods Provide Unbiased Estimates of a Breastfeeding Intervention? A Within-Study Comparison of Peer Counseling in Oregon.,"Between July 2005 and July 2007, the Oregon Supplemental Nutrition Program for Women, Infants and Children program conducted the largest randomized field experiment (RFE) ever in the United States to assess the effectiveness of a low-cost peer counseling intervention to promote exclusive breastfeeding. We undertook a within-study comparison of the intervention using unique administrative data between July 2005 and July 2010. We found no difference between experimental and nonexperimental estimates but failed to determine correspondence based on more stringent criteria. We show that tests for nonconsent bias in the benchmark RFE might provide an important signal as to confounding in the nonexperimental estimates.",2019,We found no difference between experimental and nonexperimental estimates but failed to determine correspondence based on more stringent criteria.,[],"['Peer Counseling', 'low-cost peer counseling intervention to promote exclusive breastfeeding']",[],[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3650830', 'cui_str': 'Promotion of exclusive breastfeeding (procedure)'}]",[],,0.0165471,We found no difference between experimental and nonexperimental estimates but failed to determine correspondence based on more stringent criteria.,"[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Altindag', 'Affiliation': 'Bentley University, Waltham, MA, USA.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Joyce', 'Affiliation': 'Department of Economics and Finance, Baruch College, New York, NY, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Reeder', 'Affiliation': 'Oregon WIC Program, Portland, OR, USA.'}]",Evaluation review,['10.1177/0193841X19865963']
989,20124231,Intravenous immunoglobulin treatment of the complex regional pain syndrome: a randomized trial.,"BACKGROUND


Treatment of long-standing complex regional pain syndrome (CRPS) is empirical and often of limited efficacy. Preliminary data suggest that the immune system is involved in sustaining this condition and that treatment with low-dose intravenous immunoglobulin (IVIG) may substantially reduce pain in some patients.
OBJECTIVE


To evaluate the efficacy of IVIG in patients with longstanding CRPS under randomized, controlled conditions.
DESIGN


A randomized, double-blind, placebo-controlled crossover trial. (National Research Registry number: N0263177713; International Standard Randomised Controlled Trial Number Registry: 63918259)
SETTING


University College London Hospitals Pain Management Centre.
PATIENTS


Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment.
INTERVENTION


IVIG, 0.5 g/kg, and normal saline in separate treatments, divided by a washout period of at least 28 days.
MEASUREMENTS


The primary outcome was pain intensity 6 to 19 days after the initial treatment and the crossover treatment.
RESULTS


13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial. The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001). In 3 patients, pain intensity after IVIG was less than after saline by 50% or more. No serious adverse reactions were reported.
LIMITATION


The trial was small, and recruitment bias and chance variation could have influenced results and their interpretation.
CONCLUSION


IVIG, 0.5 g/kg, can reduce pain in refractory CRPS. Studies are required to determine the best immunoglobulin dose, the duration of effect, and when repeated treatments are needed.
PRIMARY FUNDING SOURCE


Association of Anaesthetists of Great Britain and Ireland, University College London Hospitals Charity, and CSL-Behring.",2010,"The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001).","['University College London Hospitals Pain Management Centre', 'complex regional pain syndrome', '13 eligible participants were randomly assigned between November 2005 and May 2008; 12 completed the trial', 'patients with longstanding CRPS under randomized, controlled conditions', 'Persons who had pain intensity greater than 4 on an 11-point (0 to 10) numerical rating scale and had CRPS for 6 to 30 months that was refractory to standard treatment']","['Intravenous immunoglobulin', 'placebo']","['serious adverse reactions', 'pain', 'pain intensity', 'average pain intensity']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0458219', 'cui_str': 'CRPS (Complex Regional Pain Syndromes)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",13.0,0.514229,"The average pain intensity was 1.55 units lower after IVIG treatment than after saline (95% CI, 1.29 to 1.82; P < 0.001).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goebel', 'Affiliation': 'University of Liverpool, Clinical Sciences Building, University Hospital Aintree, Liverpool L9 7AL, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Baranowski', 'Affiliation': ''}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Maurer', 'Affiliation': ''}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Ghiai', 'Affiliation': ''}, {'ForeName': 'Candy', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': ''}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/0003-4819-152-3-201002020-00006']
990,27633636,Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India.,"INTRODUCTION


We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting.
METHODS AND ANALYSIS


The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation.
ETHICS AND DISSEMINATION


The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation.
TRIAL REGISTRATION NUMBER


CTRI/2013/04/003557.",2016,"We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India.",['patients with stroke-related disability'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",[],[],,0.0965285,"We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India.","[{'ForeName': 'Hueiming', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alim', 'Affiliation': 'George Institute for Global Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Felix', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Dorcas B C', 'Initials': 'DB', 'LastName': 'Gandhi', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Shweta J', 'Initials': 'SJ', 'LastName': 'Verma', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Deepak Kumar', 'Initials': 'DK', 'LastName': 'Tugnawat', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Syrigapu', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Ramaprabhu Krishnappa', 'Initials': 'RK', 'LastName': 'Ramamurthy', 'Affiliation': 'College of Allied Health Sciences, Gulf Medical University, Ajman, UAE.'}, {'ForeName': 'Jeyaraj D', 'Initials': 'JD', 'LastName': 'Pandian', 'Affiliation': 'Christian Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Forster', 'Affiliation': 'University of Leeds, West Yorkshire, UK.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Gudlavalleti Venkata Satyanarayana', 'Initials': 'GV', 'LastName': 'Murthy', 'Affiliation': 'Indian Institute of Public Health, Hyderabad, Telangana, India.'}, {'ForeName': 'Bindiganavale Ramaswamy', 'Initials': 'BR', 'LastName': 'Shamanna', 'Affiliation': 'School of Medical Sciences, University of Hyderabad, Hyderabad, Telangana, India.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Pallab K', 'Initials': 'PK', 'LastName': 'Maulik', 'Affiliation': 'George Institute for Global Health, Hyderabad, Telangana, India The George Institute for Global Health, Oxford University, Oxford, UK.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2016-012027']
991,18622632,Mycophenolate mofetil versus cyclosporine for remission maintenance in nephrotic syndrome.,"We performed a multi-centre randomized controlled trial to compare the efficacy of mycophenolate mofetil (MMF) to that of cyclosporine A (CsA) in treating children with frequently relapsing nephrotic syndrome and biopsy-proven minimal change disease. Of the 31 randomized initially selected patients, seven were excluded. The remaining 24 children received either MMF 1200 mg/m(2) per day (n = 12) or CsA 4-5 mg/kg per day (n = 12) during a 12-month period. Of the 12 patients in the MMF group, two discontinued the study medication. Evaluation of the changes from the baseline glomerular filtration rate showed an overall significant difference in favour of MMF over the treatment period (p = 0.03). Seven of the 12 patients in the MMF group and 11 of the 12 patients in the CsA group remained in complete remission during the entire study period. Relapse rate in the MMF group was 0.83/year compared to 0.08/year in the CsA group (p = 0.08). None of the patients reported diarrhea. Pharmacokinetic profiles of mycophenolic acid were performed in seven patients. The patient with the lowest area under the curve had three relapses within 6 months. In children with frequently relapsing minimal change nephrotic syndrome, MMF has a favourable side effect profile compared to CsA; however, there is a tendency towards a higher relapse risk in patients treated with MMF.",2008,Relapse rate in the MMF group was 0.83/year compared to 0.08/year in the CsA group (p = 0.08).,"['seven patients', 'nephrotic syndrome', '31 randomized initially selected patients, seven were excluded', 'children with frequently relapsing nephrotic syndrome and biopsy-proven minimal change disease']","['Mycophenolate mofetil versus cyclosporine', 'mycophenolate mofetil (MMF', 'MMF', 'mycophenolic acid', 'cyclosporine A (CsA']","['Relapse rate', 'complete remission', 'diarrhea']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic Syndrome'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0027721', 'cui_str': 'Minimal Change Disease'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",7.0,0.0688121,Relapse rate in the MMF group was 0.83/year compared to 0.08/year in the CsA group (p = 0.08).,"[{'ForeName': 'Eiske M', 'Initials': 'EM', 'LastName': 'Dorresteijn', 'Affiliation': ""Department of Pediatric Nephrology, Erasmus Medical Center/Sophia Children's Hospital, Rotterdam, the Netherlands. e.dorresteijn@erasmusmc.nl""}, {'ForeName': 'Joana E', 'Initials': 'JE', 'LastName': 'Kist-van Holthe', 'Affiliation': ''}, {'ForeName': 'Elena N', 'Initials': 'EN', 'LastName': 'Levtchenko', 'Affiliation': ''}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Nauta', 'Affiliation': ''}, {'ForeName': 'Wim C J', 'Initials': 'WC', 'LastName': 'Hop', 'Affiliation': ''}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'van der Heijden', 'Affiliation': ''}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-008-0899-6']
992,31825075,A Carbohydrate Beverage Reduces Monocytes Expressing TLR4 in Children with Overweight or Obesity.,"BACKGROUND


Childhood obesity is increasing, with about one-third of children overweight or obese. Obesity is characterized by a state of chronic low-grade inflammation that is related to cardiometabolic comorbidities. Inflammatory monocytes, which are classified into 3 different groups-classical, intermediate, and nonclassical monocytes, with Toll-like receptor 4 (TLR4+) expression indicating a proinflammatory state-underlie several obesity-associated morbidities.
OBJECTIVES


This study aimed to assess the responses of monocyte populations to beverages of differing macronutrient composition in children with healthy weight (HW) or overweight/obesity (OW/OB).
METHODS


Ten HW children (5th to 84.9th percentile; mean age 12.29 ± 2.5 y) and 7 children with OW/OB (85th to 99.99th percentile; mean age 11.96 ± 3.8 y) completed the study. Adiposity was determined via DXA. Using a double-blinded, randomized, crossover design, participants consumed either a high-carbohydrate (CHO; 210 kcal; 0 g fat/56 g carbohydrates/0 g protein) or a whole-egg-based high-protein/fat (EGG; 210 kcal; 15 g fat/0 g carbohydrates/18 g protein) beverage. Venous blood was collected at baseline and 2 h postprandially for evaluation of metabolic and inflammatory responses. Repeated measures ANOVA and Pearson correlations were conducted.
RESULTS


Consuming the CHO beverage significantly reduced the primary outcome: TLR4+ expression on classical monocytes in children with OW/OB only (25.60% decrease from baseline in OW/OB compared with 1.61% increase in HW). Children with OW/OB had significantly less percentages of TLR4+ nonclassical monocytes than HW (47.66% lower after CHO). Insulin and glucose (secondary outcomes), were significantly higher after the CHO condition compared with baseline (230.61% and 9.93% increase, respectively). Changes in glucose were significantly and negatively related to changes in monocyte populations in the CHO condition.
CONCLUSIONS


These data suggest that high-carbohydrate beverages alter monocyte populations in the blood in children with OW/OB, which is related to glucose metabolism. These findings have implications for nutritional recommendations in children with overweight/obesity. National Clinical Trial registry trial number: NCT03597542.",2020,Children with OW/OB had significantly less percentages of TLR4+ nonclassical monocytes than HW (47.66% lower after CHO).,"['children with OW/OB', 'Children with Overweight or Obesity', 'children with overweight/obesity', ' mean age 12.29\xa0±\xa02.5 y) and 7 children with OW/OB (85th to 99.99th percentile; mean age 11.96\xa0±\xa03.8 y) completed the study', 'Ten HW children ', 'children overweight or obese', 'children with healthy weight (HW) or overweight/obesity (OW/OB']","['Carbohydrate Beverage', 'high-carbohydrate (CHO; 210 kcal; 0\xa0g fat/56\xa0g carbohydrates/0\xa0g protein) or a whole-egg-based high-protein/fat (EGG; 210 kcal; 15\xa0g fat/0\xa0g carbohydrates/18\xa0g protein) beverage']","['Changes in glucose', 'Adiposity', 'Insulin and glucose', 'classical monocytes', 'TLR4+ nonclassical monocytes', 'Venous blood']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}]",10.0,0.0405511,Children with OW/OB had significantly less percentages of TLR4+ nonclassical monocytes than HW (47.66% lower after CHO).,"[{'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'Niemiro', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Chiarlitti', 'Affiliation': 'School of Human Kinetics, Brain and Mind Institute, Centre on Neuromuscular Disease, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'De Lisio', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz294']
993,32074243,New Evidence Supporting a Novel Conceptual Framework for Distinguishing Proportionate and Disproportionate Functional Mitral Regurgitation.,"Importance


Traditionally, physicians distinguished between mitral regurgitation (MR) as a determinant of outcomes and MR as a biomarker of left-ventricular (LV) dysfunction by designating the lesions as primary or secondary, respectively. In primary MR, leaflet abnormalities cause the MR, resulting in modest increases in LV end-diastolic volume over time, whereas in patients with classic secondary MR, LV dysfunction and dilatation lead to MR without structural leaflet abnormalities. However, certain patients with global LV disease (eg, those with left bundle branch block or regional wall motion abnormalities) have the features of primary MR and might respond favorably to interventions that aim to restore the proper functioning of the mitral valve apparatus.
Observations


A novel conceptual framework is proposed, which classifies patients with meaningful LV disease based on whether the severity of MR is proportionate or disproportionate to the LV end-diastolic volume. Treatments that reduce LV volumes (eg, neurohormonal antagonists) are effective in proportionate MR but not disproportionate MR. Conversely, procedures that restore mitral valve function (eg, cardiac resynchronization and mitral valve repair) are effective in patients with disproportionate MR but not in those with proportionate MR. The proposed framework explains the discordant findings in the Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR) and the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trials; differences in procedural success and medical therapy in the 2 studies cannot explain the different results. In addition, the small group of patients in the COAPT trial who had the features of proportionate MR and were similar to those enrolled in the MITRA-FR trial did not respond favorably to transcatheter mitral valve repair.
Conclusions and Relevance


The characterization of patients with functional MR into proportionate and disproportionate subtypes may explain the diverse range of responses to drug and device interventions that have been observed.",2020,"Treatments that reduce LV volumes (eg, neurohormonal antagonists) are effective in proportionate MR but not disproportionate MR.","['classifies patients with meaningful LV disease', 'Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trials', 'patients with disproportionate MR', 'certain patients with global LV disease (eg, those with left bundle branch block or regional wall motion abnormalities', 'Patients With Severe Secondary Mitral Regurgitation (MITRA-FR']","['MitraClip Percutaneous Therapy', 'Percutaneous Mitral Valve Repair MitraClip Device']",['LV end-diastolic volume'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation (disorder)'}, {'cui': 'C0205350', 'cui_str': 'Disproportionate (qualifier value)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0006384', 'cui_str': 'Bundle-Branch Block'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.0353613,"Treatments that reduce LV volumes (eg, neurohormonal antagonists) are effective in proportionate MR but not disproportionate MR.","[{'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Scott & White Heart and Vascular Hospital, Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Grayburn', 'Affiliation': 'Baylor Scott & White Heart and Vascular Hospital, Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas.'}]",JAMA cardiology,['10.1001/jamacardio.2019.5971']
994,32430870,Preliminary effects of treating the half of high latent hyperopia on refractive and visual results of femtosecond laser-assisted in situ keratomileusis in subjects with hyperopia.,"BACKGROUND


To evaluate the preliminary effects of treating the half of high latent hyperopia on refractive and visual outcomes of femtosecond laser-assisted in situ keratomileusis (LASIK) in young subjects with hyperopia.
METHODS


This non-randomized comparative study includes 120 eyes of 60 subjects who underwent femtosecond LASIK to correct hyperopia. Group 1 (n = 60) includes subjects with ≤ 1D algebraic difference (DRSE) between cycloplegic (CRSE) and manifest (MRSE) refraction spherical equivalents and was treated by entering manifest refraction values. Group 2 includes subjects with > 1D DRSE and was treated by entering the mean manifest and cycloplegic refraction values. Refractive and subjective outcomes obtained at the 1-, 3-, and 6-month postoperative visits were compared.
RESULTS


The mean age of the subjects was 26.2 ± 3.5 and 26.2 ± 5.2 years for Group 1 and Group 2, respectively. The male-to-female ratios were 10/10 in both groups. Demographic values of the groups were similar (p > 0.05). Preoperative MRSE values were similar (p = 0.924), while CRSE and DRSE values were significantly higher in Group 2 (p < 0.001). At the 1- and 3-month postoperative visits, MRSE was higher and uncorrected distance visual acuity (UDVA) was lower in Group 2 (p < 0.001). Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05).
CONCLUSION


At the 6-month visit after treating the half of > 1D latent hyperopia with femtosecond LASIK, refractive and visual outcomes like MRSE, UDVA, subjective visual parameters, and quality of vision scores become similar to those obtained in ≤ 1D latent hyperopia.",2020,"Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05).
","['The mean age of the subjects was 26.2\u2009±\u20093.5 and 26.2\u2009±', 'young subjects with hyperopia', 'subjects with hyperopia', '120 eyes of 60 subjects who underwent femtosecond LASIK to correct hyperopia']","['femtosecond laser-assisted in situ keratomileusis (LASIK', 'femtosecond laser-assisted']","['Subjective visual parameters and quality of vision scores', 'uncorrected distance visual acuity (UDVA', 'MRSE, UDVA, some subjective visual parameters, and quality of vision scores', 'femtosecond LASIK, refractive and visual outcomes like MRSE, UDVA, subjective visual parameters, and quality of vision scores', 'CRSE and DRSE values', 'Demographic values', 'subjects with ≤\u20091D algebraic difference (DRSE) between cycloplegic (CRSE) and manifest (MRSE) refraction spherical equivalents', 'Preoperative MRSE values']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0020490', 'cui_str': 'Hypermetropia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]","[{'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",,0.0280514,"Subjective visual parameters and quality of vision scores were also worse in Group 2 during these visits (p < 0.001); however, at the 6-month visit, all outcomes for Group 2 improved, and MRSE, UDVA, some subjective visual parameters, and quality of vision scores became similar between groups (p > 0.05).
","[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Ozulken', 'Affiliation': 'Department of Ophthalmology, TOBB ETU, Ankara, Turkey.'}, {'ForeName': 'Cagri', 'Initials': 'C', 'LastName': 'Ilhan', 'Affiliation': 'Department of Ophthalmology, Hatay State Hospital, Antakya, Hatay, Turkey. cagriilhan@yahoo.com.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Yuksel', 'Affiliation': 'Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Boston, MA, USA.'}, {'ForeName': 'Tarkan', 'Initials': 'T', 'LastName': 'Mumcuoglu', 'Affiliation': 'Department of Ophthalmology, TOBB ETU, Ankara, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01421-5']
995,31738365,Does Guideline-Directed Medical Therapy for Heart Failure Offer Benefits After LVAD Placement?-A Call for a Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.122134,,"[{'ForeName': 'Clyde W', 'Initials': 'CW', 'LastName': 'Yancy', 'Affiliation': 'Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles Medical Center, Los Angeles.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Associate Editor.'}]",JAMA cardiology,['10.1001/jamacardio.2019.5019']
996,18648230,Low-dose propofol-induced amnesia is not due to a failure of encoding: left inferior prefrontal cortex is still active.,"BACKGROUND


Propofol may produce amnesia by affecting encoding. The hypothesis that propofol weakens encoding was tested by measuring regional cerebral blood flow during verbal encoding.
METHODS


Seventeen volunteer participants (12 men; aged 30.4 +/- 6.5 yr) had regional cerebral blood flow measured using H2O positron emission tomography during complex and simple encoding tasks (deep vs. shallow level of processing) to identify a region of interest in the left inferior prefrontal cortex (LIPFC). The effect of either propofol (n = 6, 0.9 microg/ml target concentration), placebo with a divided attention task (n = 5), or thiopental at sedative doses (n = 6, 3 microg/ml) on regional cerebral blood flow activation in the LIPFC was tested. The divided attention task was expected to decrease activation in the LIPFC.
RESULTS


Propofol did not impair encoding performance or reaction times, but impaired recognition memory of deeply encoded words 4 h later (median recognition of 35% [interquartile range, 17-54%] of words presented during propofol vs. 65% [38-91%] before drug; P < 0.05). Statistical parametric mapping analysis identified a region of interest of 6.6 cm in the LIPFC (T = 7.44, P = 0.014). Regional cerebral blood flow response to deep encoding was present in this region of interest in each group before drug (T > 4.41, P < 0.04). During drug infusion, only the propofol group continued to have borderline significant activation in this region (T = 4.00, P = 0.063).
CONCLUSIONS


If the amnesic effect of propofol were solely due to effects on encoding, activation in the LIPFC should be minimal. Because LIPFC activation was not totally eliminated by propofol, the amnesic action of propofol must be present in other brain regions and/or affect other memory processes.",2008,"During drug infusion, only the propofol group continued to have borderline significant activation in this region (T = 4.00, P = 0.063).
",['Seventeen volunteer participants (12 men; aged 30.4 '],"['propofol', 'placebo with a divided attention task (n = 5), or thiopental at sedative doses', 'Propofol', 'H2O positron emission tomography during complex and simple encoding tasks (deep vs. shallow level of processing']","['Regional cerebral blood flow response', 'regional cerebral blood flow activation', 'encoding performance or reaction times', 'regional cerebral blood flow', 'recognition memory of deeply encoded words 4 h later (median recognition']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039925', 'cui_str': 'Thiopental'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C4554317', 'cui_str': 'Deeply - dosing instruction fragment (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",17.0,0.0413063,"During drug infusion, only the propofol group continued to have borderline significant activation in this region (T = 4.00, P = 0.063).
","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Veselis', 'Affiliation': 'Department of Anesthesiology (Box 24), Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, New York 10065, USA. veselisr@mskcc.org'}, {'ForeName': 'Kane O', 'Initials': 'KO', 'LastName': 'Pryor', 'Affiliation': ''}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Reinsel', 'Affiliation': ''}, {'ForeName': 'Meghana', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0b013e31817fd8ae']
997,31837032,Can text messages save lives? A field experiment on blood donor motivation.,"BACKGROUND


Continuous effort around the globe is exerted into donor management, with the overall aim of keeping a constant flow of new donations. To achieve this goal, blood banks and blood donor associations are taking initiatives to get the same donor to make repeated donations. In general, such initiatives are implemented without proper evaluation. This study circumvents this trend and evaluates the effect on donations from sending blood donors a text message when their donation has helped a patient.
METHODS AND MATERIALS


In a large-scale field experiment (n = 20,365), we randomized donors such that half are sent a text message when their donation was used. Among those who were randomized to the text message, we also randomized the time of day the text message was sent.
RESULTS


The messages increased subsequent donations by 3.6% (p = 0.023), compared with donors who did not get the message. It was also shown that optimizing the time of day when the text messages were sent increased the effect substantially. Text messages sent in the evening increased donations by 6.5% (p = 0.011). Finally, it was found that, among whole blood donors, the text messages did not have a significant effect (p = 0.554), whereas it did among the plasma donors (p = 0.003).
CONCLUSION


Several blood banks have adopted the strategy of sending blood donors a text message that acknowledges that donors' contributions helped a patient. This study is the first to formally test the effects of such a message with a control group.",2020,"The messages increased subsequent donations by 3.6% (p = 0.023), compared with donors who did not get the message.",[],[],"['blood donor motivation', 'subsequent donations']",[],[],"[{'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]",,0.0305997,"The messages increased subsequent donations by 3.6% (p = 0.023), compared with donors who did not get the message.","[{'ForeName': 'Toke', 'Initials': 'T', 'LastName': 'Fosgaard', 'Affiliation': 'Department of Food and Resource Economics, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hansen', 'Affiliation': 'Department of Food and Resource Economics, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Catrine', 'Initials': 'C', 'LastName': 'Jacobsen', 'Affiliation': 'Bro Kommunikation, Esplanaden, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Sørensen', 'Affiliation': 'Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Romose', 'Affiliation': 'Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ullum', 'Affiliation': 'Copenhagen Hospital Biobank Unit, Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Transfusion,['10.1111/trf.15633']
998,32432669,Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial.,"Importance


Factors contributing to underrepresentation of women in surgery are incompletely understood. Pro-male bias and stereotype threat appear to contribute to gender imbalance in surgery.
Objectives


To evaluate the association between pro-male gender bias and career engagement and the effect of stereotype threat on skill performance among trainees in academic surgery.
Design, Setting, and Participants


A 2-phase study with a double-blind, randomized clinical trial component was conducted in 3 academic general surgery training programs. Residents were recruited between August 1 and August 15, 2018, and the study was completed at the end of that academic year. In phase 1, surveys administered 5 to 6 months apart investigated the association of gender bias with career engagement. In phase 2, residents were randomized 1:1 using permuted-block design stratified by site, training level, and gender to receive either a trigger of or protection against stereotype threat. Immediately after the interventions, residents completed the Fundamentals of Laparoscopic Surgery (FLS) assessment followed by a final survey. A total of 131 general surgery residents were recruited; of these 96 individuals with academic career interests met eligibility criteria; 86 residents completed phase 1. Eighty-five residents were randomized in phase 2, and 4 residents in each arm were lost to follow-up.
Intervention


Residents read abstracts that either reported that women had worse laparoscopic skill performance than men (trigger of stereotype threat [A]) or had no difference in performance (protection against stereotype threat [B]).
Main Outcomes and Measures


Association between perception of pro-male gender bias and career engagement survey scores (phase 1) and stereotype threat intervention and FLS scores (phase 2) were the outcomes. Intention-to-treat analysis was conducted.
Results


Seventy-seven residents (38 women [49.4%]) completed both phases of the study. The association between pro-male gender bias and career engagement differed by gender (interaction coefficient, -1.19; 95% CI, -1.90 to -0.49; P = .02); higher perception of bias was associated with higher engagement among men (coefficient, 1.02; 95% CI, 0.19-2.24; P = .04), but no significant association was observed among women (coefficient, -0.25; 95% CI, -1.59 to 1.08; P = .50). There was no evidence of a difference in FLS score between interventions (mean [SD], A: 395 [150] vs B: 367 [157]; P = .51). The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39). The association between stereotype threat activation and FLS score differed by gender across levels of susceptibility to stereotype threat (interaction coefficient, -35.3; 95% CI, -47.0 to -23.6; P = .006). Higher susceptibility to stereotype threat was associated with lower FLS scores among women who received a stereotype threat trigger (coefficient, -43.4; 95% CI, -48.0 to -38.9; P = .001).
Conclusions and Relevance


Perception of pro-male bias and gender stereotypes may influence career engagement and skill performance, respectively, among surgical trainees.
Trial Registration


ClinicalTrials.gov Identifier: NCT03623009.",2020,"The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39).","['Results\n\n\nSeventy-seven residents (38 women [49.4%]) completed both phases of the study', '3 academic general surgery training programs', 'Residents were recruited between August 1 and August 15, 2018, and the study was completed at the end of that academic year', 'Eighty-five residents', '131 general surgery residents were recruited; of these 96 individuals with academic career interests met eligibility criteria; 86 residents completed phase 1', 'Surgical Training', 'trainees in academic surgery']","['trigger of or protection against stereotype threat', 'stereotype threat']","['perception of pro-male gender bias and career engagement survey scores (phase 1) and stereotype threat intervention and FLS scores (phase 2', 'stereotype threat activation and FLS score', 'FLS scores', 'performance (protection against stereotype threat [B', 'skill performance', 'FLS score', 'laparoscopic skill performance', 'response to stereotype threat activation']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]",131.0,0.222041,"The response to stereotype threat activation was similar in men and women (interaction coefficient, 15.1; 95% CI, -124.5 to 154.7; P = .39).","[{'ForeName': 'Sara P', 'Initials': 'SP', 'LastName': 'Myers', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Dasari', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Lumpkin', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chaumont', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Downs-Canner', 'Affiliation': 'Department of Surgery, University of North Carolina at Chapel Hill School of Medicine.'}, {'ForeName': 'Meghan R', 'Initials': 'MR', 'LastName': 'Flanagan', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Rosengart', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA surgery,['10.1001/jamasurg.2020.1127']
999,31876922,Limited Conclusions Can Be Reached From Danish Randomized Clinical Trial of Supported Employment.,,2020,,[],[],[],[],[],[],,0.141252,,"[{'ForeName': 'Kim T', 'Initials': 'KT', 'LastName': 'Mueser', 'Affiliation': 'Center for Psychiatric Rehabilitation, Department of Occupational Therapy, Boston University, Boston, Massachusetts.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'McGurk', 'Affiliation': 'Center for Psychiatric Rehabilitation, Department of Occupational Therapy, Boston University, Boston, Massachusetts.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4177']
1000,31876925,Limited Conclusions Can Be Reached From Danish Randomized Clinical Trial of Supported Employment-Reply.,,2020,,[],[],[],[],[],[],,0.129909,,"[{'ForeName': 'Thomas Nordahl', 'Initials': 'TN', 'LastName': 'Christensen', 'Affiliation': 'Mental Health Centre Copenhagen, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Nordentoft', 'Affiliation': 'Mental Health Centre Copenhagen, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene Falgaard', 'Initials': 'LF', 'LastName': 'Eplov', 'Affiliation': 'Research Unit, Mental Health Centre Copenhagen, Copenhagen, Denmark.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4180']
1001,32014293,"Comparing the effectiveness of simulation as adjuncts to standardized lectures, on the identification and reporting of intimidation during surgical clerkship: A mixed method randomized controlled trial.","BACKGROUND


Intimidation constitutes a learning barrier for undergraduates and its reporting rate to authorities remains suboptimal.
METHODS


A randomized controlled trial was conducted to evaluate the effectiveness of three interventions designed to increase reporting by undergraduates during their surgical rotation. As adjuncts to a standardized lecture, participants were assigned to a simulated intimidation scenario, a video of intimidation events, or a control group. Surveys were completed before the interventions, and at the end of the rotation.
RESULTS


Of the 119 included participants, 17.6% reported that they had been intimidated during their previous rotation as compared to 37.0% after the surgical rotation. There were no statistically significant differences in the reporting of intimidation between the groups. However, 65.5% of all participants declared feeling more at ease to report intimidation, yet the reporting rate remained low.
CONCLUSION


Intimidation during clerkship persists as a frequent problem although the best method to increase its reporting remains unclear.",2020,There were no statistically significant differences in the reporting of intimidation between the groups.,['Of the 119 included participants'],[],[],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],[],119.0,0.109104,There were no statistically significant differences in the reporting of intimidation between the groups.,"[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Thivierge-Southidara', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Canada; Faculty of Medicine, Université Laval, Canada. Electronic address: maureen.thivierge-southidara@umontreal.ca.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Rodriguez-Qizilbash', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Canada; Faculty of Medicine, McGill University, Canada.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Vincelette', 'Affiliation': 'School of Nursing, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Canada; Research Centre Charles-Le-Moyne-Saguenay-Lac-Saint-Jean sur les innovations en santé, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Dubrowski', 'Affiliation': ""Canada Research Chair in HealthCare Simulation, Ontario Tech University, Faculty of Health Sciences, Canada; Department of Education and CHUM Academy, Centre Hospitalier de l'Université de Montréal, Canada.""}, {'ForeName': 'Kerianne', 'Initials': 'K', 'LastName': 'Boulva', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Centre Hospitalier de l'Université de Montréal, Canada.""}, {'ForeName': 'Ramses', 'Initials': 'R', 'LastName': 'Wassef', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Centre Hospitalier de l'Université de Montréal, Canada.""}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Godbout', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Hôpital Notre-Dame de Montréal, Canada.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Patocskai', 'Affiliation': ""Faculty of Medicine, Université de Montréal, Canada; Department of Surgery, Centre Hospitalier de l'Université de Montréal, Canada.""}]",American journal of surgery,['10.1016/j.amjsurg.2020.01.025']
1002,32087836,Enhancing engagement in evidence-based tobacco cessation treatment for smokers with mental illness: A pilot randomized trial.,"OBJECTIVE


To evaluate the efficacy of a brief telephone-delivered Motivational Interviewing (MI)-based intervention to facilitate engagement in evidence-based cessation treatment for Veterans with mental illness referred to smoking cessation treatment.
METHODS


86 military Veteran smokers with mental illness were recruited from a tobacco cessation consult clinic and randomized to receive either a MI-based treatment engagement intervention (TE; n = 48) or a non-MI assessment and information control (CON; n = 38) condition. Intervention was delivered during a single brief telephone contact. Primary engagement outcomes were 1) attending a treatment session within 30 days and 2) combination treatment (attending session plus using pharmacotherapy). Cessation outcomes included self-reported 24 h cessation attempts and 7 day point abstinence at 3 months post-intervention. Outcomes were assessed at 1 and 3 months post intervention.
RESULTS


Outcome analyses included 85 participants (47 TE, 38 CON) using an intent-to-treat analytic approach. Participants were on average 49.5 (13.4) years old, 88% Male, 59% white, 18% African American and 14% Hispanic/Latino(a). Following intervention delivery TE and CON participants did not differ on likelihood of attending a treatment session during the subsequent 30 days (47% vs 45%, respectively). A significant difference was observed when classified as utilizing combination treatment, 40% of TE versus 18% of CON reported use of smoking cessation medication and behavioral counseling (p = 0.04). No statistical differences were observed for cessation outcomes, although more TE than CON participants reported 7 day point abstinence at 3 months post-intervention (30% vs 18%).
CONCLUSIONS


The present pilot study provides initial evidence for the feasibility, acceptability and efficacy of a telephone delivered TE intervention for enhancing engagement in combinationevidence evidence-based treatment in a sample of Veteran smokers with mental illness referred to smoking cessation treatment. Smokers with mental illness typically have greater difficulty stopping smoking than those without mental illness. Increased engagement in combination treatment thus has the potential to increase quit rates and ultimately reduce the burden of tobacco use for this population.",2020,"No statistical differences were observed for cessation outcomes, although more TE than CON participants reported 7 day point abstinence at 3 months post-intervention (30% vs 18%).
","['Participants were on average 49.5 (13.4) years old, 88% Male, 59% white, 18% African American and 14% Hispanic/Latino(a', 'Veteran smokers with mental illness referred to smoking cessation treatment', '86 military Veteran smokers with mental illness were recruited from a tobacco cessation consult clinic and randomized to receive either a', 'Smokers with mental illness', 'smokers with mental illness', 'Veterans with mental illness referred to smoking cessation treatment']","['telephone delivered TE intervention', 'MI-based treatment engagement intervention (TE; n\xa0=\xa048) or a non-MI assessment and information control (CON; n\xa0=\xa038) condition', 'CON', 'telephone-delivered Motivational Interviewing (MI)-based intervention']","['self-reported 24\xa0h cessation attempts and 7\xa0day point abstinence', 'smoking cessation medication and behavioral counseling', 'quit rates']","[{'cui': 'C4517558', 'cui_str': 'Thirteen point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}]",88.0,0.0959386,"No statistical differences were observed for cessation outcomes, although more TE than CON participants reported 7 day point abstinence at 3 months post-intervention (30% vs 18%).
","[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Myers', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA 92161, USA; Department of Psychiatry University of California, 9500 Gilman Dr. La Jolla, San Diego, CA 92093-0603, USA. Electronic address: mgmyers@ucsd.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, 9500 Gilman Dr. La Jolla, San Diego, CA 92093-0807, USA. Electronic address: dstrong@ucsd.edu.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Chen', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA 92161, USA; Department of Psychiatry University of California, 9500 Gilman Dr. La Jolla, San Diego, CA 92093-0603, USA. Electronic address: tic072@ucsd.edu.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, 9500 Gilman Dr. La Jolla, San Diego, CA 92093-0807, USA. Electronic address: slinke@ucsd.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.012']
1003,17686479,Anastrozole or letrozole for ovulation induction in clomiphene-resistant women with polycystic ovarian syndrome: a prospective randomized trial.,"OBJECTIVE


To compare the effects of letrozole (2.5 mg) and anastrozole (1 mg) meant for ovulation induction in clomiphene (CC)-resistant women with PCOS.
DESIGN


Prospective randomized trial.
SETTING


University teaching hospital and private practice setting.
PATIENT(S)


The study comprised a total of 220 infertile women (574 cycles) with CC-resistant PCOS.
INTERVENTION(S)


Patients were randomized to treatment with 2.5 mg of letrozole daily (111 patients, 295 cycles) or 1 mg of anastrozole daily (109 patients, 279 cycles) for 5 days from day 3 of menses.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum E(2), serum P, endometrial thickness, pregnancy rate (PR), and miscarriage rate.
RESULT(S)


The total number of follicles was significantly more in the anastrozole group (5.4 +/- 0.4 vs. 5.8 +/- 0.4). The number of follicles > or = 14 mm (3.1 +/- 0.3 vs. 2.7 +/- 0.2) and > or = 18 mm (2.3 +/- 0.1 vs. 3.1 +/- 0.2) were significantly higher in the anastrozole group. The endometrial thickness at the time of hCG administration was significantly more in the anastrozole group (9.1 +/- 0.2 vs. 10.2 +/- 0.7 mm). The duration to reach a dominant follicle was longer in the letrozole group (12.1 +/- 1.3 days vs. 8.8 +/- 1.9 days) but without statistical significant difference. Ovulation occurred in 183/295 cycles (62%) in the letrozole group and 177/279 cycles (63.4%) in the anastrozole group, whereas pregnancy occurred in 36/295 cycles (12.2%) in the letrozole group and 42/279 cycles (15.1%) in the anastrozole group and the differences were not statistically significant.
CONCLUSION(S)


The results of this study did not show a significant difference in PR or miscarriage rate between anastrozole and letrozole when used for ovulation induction in women with CC-resistant PCOS.",2008,The endometrial thickness at the time of hCG administration was significantly more in the anastrozole group (9.1 +/-,"['women with CC-resistant PCOS', 'University teaching hospital and private practice setting', 'clomiphene (CC)-resistant women with PCOS', '220 infertile women (574 cycles) with CC-resistant PCOS', 'clomiphene-resistant women with polycystic ovarian syndrome']","['Anastrozole or letrozole', 'anastrozole', 'letrozole', 'anastrozole and letrozole']","['Number of follicles, serum E(2), serum P, endometrial thickness, pregnancy rate (PR), and miscarriage rate', 'endometrial thickness', 'Ovulation', 'total number of follicles', 'pregnancy', 'duration to reach a dominant follicle', 'PR or miscarriage rate']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",220.0,0.0807456,The endometrial thickness at the time of hCG administration was significantly more in the anastrozole group (9.1 +/-,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Mosbah', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Shady', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.05.010']
1004,17582406,Clomiphene citrate or letrozole for ovulation induction in women with polycystic ovarian syndrome: a prospective randomized trial.,"OBJECTIVE


To compare the effects of letrozole (5 mg) and clomiphene citrate (100 mg) for ovulation induction in women with polycystic ovary syndrome (PCOS).
DESIGN


Prospective randomized trial.
SETTING


University teaching hospital and private practice setting.
PATIENT(S)


The study comprised a total of 438 infertile women (1063 cycles) with PCOS.
INTERVENTION(S)


Patients were randomized to treatment with 5 mg of letrozole daily (218 patients, 545 cycles) or 100 mg of clomiphene citrate daily (220 patients, 518 cycles) for 5 days starting on day 3 of menses. Timed intercourse was advised 24 to 36 hours after hCG injection.
MAIN OUTCOME MEASURE(S)


Number of follicles, serum estradiol, serum progesterone, endometrial thickness, and pregnancy and miscarriage rates.
RESULT(S)


The mean age, parity, and duration of infertility in both groups were similar. The total number of follicles was statistically significantly greater in the clomiphene citrate group (6.8 +/- 0.3 versus 4.4 +/- 0.4). Endometrial thickness at the time of hCG administration was statistically significantly greater in the CC group (9.2 +/- 0.7 mm versus 8.1 +/- 0.2 mm). The duration to reach a dominant follicle was statistically significantly longer in the letrozole group (12.1 +/- 1.3 versus 8.8 +/- 2.9 days). Ovulation occurred in 365 out of 540 cycles (67.5%) in letrozole group and 371 out of 523 cycles (70.9%) without a statistically significant difference. Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group. The pregnancy rate per cycle was 15.1% in the letrozole group and 17.9% in the clomiphene citrate group without statistically difference between the groups.
CONCLUSION(S)


The results of this study did not show any advantage to the use of letrozole over clomiphene citrate as a first-line treatment for induction of ovulation in women with PCOS.",2009,Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group.,"['women with polycystic ovary syndrome (PCOS', 'University teaching hospital and private practice setting', '438 infertile women (1063 cycles) with PCOS', 'women with PCOS', 'women with polycystic ovarian syndrome']","['clomiphene citrate daily', 'Clomiphene citrate or letrozole', 'letrozole', 'clomiphene citrate']","['Number of follicles, serum estradiol, serum progesterone, endometrial thickness, and pregnancy and miscarriage rates', 'mean age, parity, and duration of infertility', 'Ovulation', 'Timed intercourse', 'pregnancy rate per cycle', 'total number of follicles', 'Levels of serum estradiol and progesterone', 'duration to reach a dominant follicle', 'Endometrial thickness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene Citrate'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}]",438.0,0.0622772,Levels of serum estradiol and progesterone were statistically significantly higher in the clomiphene citrate group.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt. Electronic address: ambadawy@yahoo.com.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Abdel Aal', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abulatta', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2007.02.062']
1005,32060584,[Positron emission tomography-guided treatment in early-stage favorable Hodgkin lymphoma: final results of the international randomized phase III HD16 trial conducted by the German Hodgkin Study Group].,,2020,,['early-stage favorable Hodgkin lymphoma'],['Positron emission tomography-guided treatment'],[],"[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C1266193', 'cui_str': 'Hodgkin lymphoma - category (morphologic abnormality)'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0249972,,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Nieder', 'Affiliation': 'Dept. of Oncology and Palliative Medicine, Nordland Hospital Trust, P.O. Box 1480, 8092, Bodø, Norwegen. cnied@hotmail.com.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01593-0']
1006,31904670,Efficacy of a Short Psychoeducational Group Intervention for the Prevention of Cardiovascular Risk in Patients With Severe Mental Disorder: A Randomized Trial.,"Psychoeducational interventions to improve healthy habits regarding cardiovascular risk (CVR) in people with a severe mental disorder showed scarce results in the literature. In this article, we showed the results of a randomized clinical trial including 80 adult outpatients (mainly psychosis spectrum) with moderate to very high CVR. A short-term psychoeducational group intervention to improve healthy habits regarding CVR was added to their as-usual individual psychoeducational schedule. With an intention-to-treat analysis, we expected improvements in the different parameters. Baseline and 1-year follow-up included CVR factors and indexes (REGICOR, SCORE, and DORICA). Basal characteristics did not show statistically significant differences between the groups. No significant improvements in any of the variables studied were observed in the intervention enriched group compared with the control individual group. Compliance with the sessions was scarce. The satisfaction with the intervention and the acquisition of knowledge were adequate. Moreover, the benefits of both interventions were weak.",2020,No significant improvements in any of the variables studied were observed in the intervention enriched group compared with the control individual group.,"['Patients', 'With Severe Mental Disorder', '80 adult outpatients (mainly psychosis spectrum) with moderate to very high CVR', 'people with a severe mental disorder']","['Short Psychoeducational Group Intervention', 'Psychoeducational interventions']","['healthy habits regarding cardiovascular risk (CVR', 'CVR factors and indexes (REGICOR, SCORE, and DORICA', 'healthy habits regarding CVR', 'Cardiovascular Risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4046029', 'cui_str': 'Mental Disorders, Severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.0565276,No significant improvements in any of the variables studied were observed in the intervention enriched group compared with the control individual group.,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Torralbas-Ortega', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Paños-Martínez', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Patró-Moncunill', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Angel Maria', 'Initials': 'AM', 'LastName': 'Santiago-Barragán', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Cobo', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Escayola-Maranges', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Granero-Lázaro', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Marti-Mestre', 'Affiliation': ""Parc Taulí Mental Health Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT-Universitat Autònoma de Barcelona.""}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001081']
1007,32081289,Muscle Complaints or Events in Patients Randomized to Simvastatin or Ezetimibe/Simvastatin.,,2020,,[],['Simvastatin or Ezetimibe/Simvastatin'],[],[],"[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}]",[],,0.0163499,,"[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Nanna', 'Affiliation': ''}, {'ForeName': 'Ann Marie', 'Initials': 'AM', 'LastName': 'Navar', 'Affiliation': ''}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ''}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': ''}, {'ForeName': 'Yale B', 'Initials': 'YB', 'LastName': 'Mitchel', 'Affiliation': ''}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Musliner', 'Affiliation': ''}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Blazing', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.022']
1008,32107012,Training with cognitive load improves performance under similar conditions in a real surgical task.,"BACKGROUND


Enhancing cognitive load while performing a bimanual surgical task affects performance. Whether repeated training under this condition could benefit performance in an operating room was tested using a virtual reality simulator with cognitive load applied through two-digit math multiplication questions.
METHOD


11 subjects were randomized to Control, VR and VR + CL groups. After a pre-test, VR and VR + CL groups repeated the peg transfer task 150 times over 15 sessions with cognitive load applied only for the last 100 trials. After training, all groups took a post-test and two weeks later the retention test with and without cognitive load and the transfer task on a pig intestine of 150 cm long under cognitive load.
RESULTS AND CONCLUSION


Mixed ANOVA analysis showed significant differences between the control and VR and VR + CL groups (p = 0.013, p = 0.009) but no differences between the VR + CL and the VR groups (p = 1.0). GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03). Training under cognitive load benefitted performance on an actual surgical task under similar conditions.",2020,"GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03).",['11 subjects'],"['Control, VR and VR\xa0+\xa0CL', 'retention test with and without cognitive load and the transfer task on a pig intestine of 150\xa0cm long under cognitive load', 'VR\xa0+\xa0CL']",[],[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],11.0,0.0101945,"GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03).","[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA. Electronic address: ganesh.sankaranarayanan@bswhealth.org.'}, {'ForeName': 'Coleman A', 'Initials': 'CA', 'LastName': 'Odlozil', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Katerina O', 'Initials': 'KO', 'LastName': 'Wells', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Leeds', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Chauhan', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Fleshman', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Jones', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Suvranu', 'Initials': 'S', 'LastName': 'De', 'Affiliation': 'Center for Modeling, Simulation, and Imaging in Medicine, Rensselaer Polytechnic Institute, Troy, NY, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.02.002']
1009,32087835,Intervention to decrease leaving without treatment among intoxicated emergency department patients.,"OBJECTIVE


Approximately 15% of the >4000 patients presenting each year to our emergency department (ED) with a chief complaint or discharge diagnosis related to alcohol were leaving without treatment (LWT). If they are not clinically sober at the time of departure, these patients are at risk for falls or other injury. Our goal was to create an intervention to decrease this rate of early departure.
METHODS


A stakeholder group identified the reasons why intoxicated patients were leaving without treatment, concluding that the primary reason patients left was there was no process in place for evaluating and caring for these patients who potentially had impaired decision-making capacity. The group created a worksheet for the triage nurse to identify and manage patients presenting with intoxication and impaired decision-making or ambulation, with protocols to keep the patient in a supervised area. We performed a before and after analysis, evaluating 12 months before and 12 months after the protocol was initiated, with the primary outcome being the rate of intoxicated patients who left without treatment. We also measured the recidivism rate (the rate of return to the ED within 24 h after departure) and the ED length of stay (LOS).
RESULTS


After the intervention was initiated, the percentage of intoxicated patients who left without treatment decreased from 15.0% to 7.4% LWT (p < 0.001). Among patients who stayed until discharge during the intervention period, the 24-hour recidivism was 9.4%, compared to 22.6% for those who left without treatment (p < 0.001). This difference in recidivism rates for each group was the same before and after the intervention, but fewer patients left without treatment after. For those patients with alcohol-related visits, the ED LOS was statistically significantly longer in the intervention phase, by a mean of 42 min for all patients (p < 0.001), as well as by a mean of 24 min for those who stayed to be dispositioned (p = 0.031).
CONCLUSION


Providing a standardized process for caring for acutely intoxicated patients leads to fewer patients leaving the ED before discharge. Patients who stay to the completion of treatment have a lower recidivism rate within 24 h after leaving than those in the leaving without treatment category.",2020,"For those patients with alcohol-related visits, the ED LOS was statistically significantly longer in the intervention phase, by a mean of 42 min for all patients (p < 0.001), as well as by a mean of 24 min for those who stayed to be dispositioned (p = 0.031).
","['intoxicated emergency department patients', '4000 patients presenting each year to our emergency department (ED) with a chief complaint or discharge diagnosis related to alcohol were leaving without treatment (LWT', 'patients who potentially had impaired decision-making capacity']","['intoxication and impaired decision-making or ambulation, with protocols to keep the patient in a supervised area']","['recidivism rates', 'recidivism rate', 'ED length of stay (LOS', '24-hour recidivism']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}]","[{'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}]",4000.0,0.042582,"For those patients with alcohol-related visits, the ED LOS was statistically significantly longer in the intervention phase, by a mean of 42 min for all patients (p < 0.001), as well as by a mean of 24 min for those who stayed to be dispositioned (p = 0.031).
","[{'ForeName': 'Leslie W', 'Initials': 'LW', 'LastName': 'Milne', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Electronic address: lmilne@mgh.harvard.edu.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Williamson', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Electronic address: dwilliamson19@partners.org.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Electronic address: ckraus2@partners.org.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Wilcox', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA. Electronic address: swilcox1@partners.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.013']
1010,32076768,"Renin aldosterone vasopressin and copeptin kinetics in patients with septic shock, a post-hoc Hyper2S randomized trial analysis.",,2020,,['patients with septic shock'],['Renin aldosterone vasopressin'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}]","[{'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0201849', 'cui_str': 'Antidiuretic hormone measurement (procedure)'}]",[],,0.200224,,"[{'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Olivier', 'Affiliation': ""Département de Médecine Intensive-Réanimation et Médecine Hyperbare, CHU d'Angers, France, 4 Rue Larrey, 49 993, Angers Cedex 9, France.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Moal', 'Affiliation': ""Département de Biochimie et de Génétique, CHU d'Angers, France, 4 Rue Larrey, 49 993, Angers Cedex 9, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saulnier', 'Affiliation': ""Département de Bio-Statistiques et de Méthodologie, CHU d'Angers, France, 4 Rue Larrey, 49 993, Angers Cedex 9, France.""}, {'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': ""Département d'Anesthésie Réanimation, CHU d'Angers, France, 4 Rue Larrey, Angers Cedex 9, France.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Radermacher', 'Affiliation': 'Institut für Anästhesiologische Pathophysiologie Und Verfahrensentwicklung, Universitätsklinikum, Ulm, Helmholtzstr. 8/1, 89081, Ulm, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Asfar', 'Affiliation': ""Département de Médecine Intensive-Réanimation et Médecine Hyperbare, CHU d'Angers, France, 4 Rue Larrey, 49 993, Angers Cedex 9, France. piasfar@chu-angers.fr.""}]",Intensive care medicine,['10.1007/s00134-019-05912-7']
1011,32072198,[Clinical implications of the PORTEC-3 trial for the treatment of high-risk endometrial cancer].,,2020,,['high-risk endometrial cancer'],[],[],"[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]",[],[],,0.0346619,,"[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Waltar', 'Affiliation': 'Universitätsklinikum Köln, Köln, Deutschland.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Marnitz', 'Affiliation': 'Universitätsklinikum Köln, Köln, Deutschland. simone.marnitz-schulze@uk-koeln.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01592-1']
1012,17199030,Lacosamide.,"Lacosamide is a new chemical entity being investigated as an adjunctive treatment for epilepsy, as well as monotherapy for diabetic neuropathic pain. Lacosamide appears to have a dual mode of action: selective enhancement of sodium channel inactivation and modulation of collapsin response mediator protein-2. Rapidly and completely absorbed after oral administration, lacosamide has an elimination half-life of approximately 13 hours and a low potential for drug interactions. Additionally, lacosamide exhibits linear, dose-proportional pharmacokinetics with low intra- and interpatient variability. Randomized controlled trials of adjunctive lacosamide (200, 400, and 600 mg/day) have demonstrated statistically significant reduction in median seizure frequency compared with placebo. In addition, 50% responder rates for lacosamide (400 and 600 mg/day) were statistically superior to placebo. The most frequently reported adverse events (> or =10% of lacosamide-treated patients) included dizziness, headache, and nausea. A double-blind, double-dummy randomized trial of intravenous lacosamide (30- and 60-minute infusion) as replacement for oral lacosamide showed that the safety and tolerability profiles were comparable for intravenous and oral lacosamide. The efficacy and safety results from completed clinical trials, as well as the favorable pharmacokinetic profile, suggest that lacosamide may represent a significant advance in antiepileptic drug therapy.",2007,"The most frequently reported adverse events (> or =10% of lacosamide-treated patients) included dizziness, headache, and nausea.",[],"['intravenous lacosamide', 'placebo', 'adjunctive lacosamide', 'Lacosamide']","['safety and tolerability profiles', 'median seizure frequency', 'dizziness, headache, and nausea', 'adverse events']",[],"[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.404095,"The most frequently reported adverse events (> or =10% of lacosamide-treated patients) included dizziness, headache, and nausea.","[{'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Doty', 'Affiliation': 'SCHWARZ BIOSCIENCES, Inc., Research Triangle Park, North Carolina 27709, USA. pamela.doty@schwarzbiosciences.com'}, {'ForeName': 'G David', 'Initials': 'GD', 'LastName': 'Rudd', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stoehr', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': ''}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,[]
1013,32103410,Implementing Parent-Teen Motivational Interviewing + Behavior Therapy for ADHD in Community Mental Health.,"Despite the promise of psychosocial interventions for adolescent Attention Deficit Hyperactivity Disorder (ADHD), there are no studies that examine their implementation in community mental health contexts. In this study, we evaluate the implementation of community-based Supporting Teens' Autonomy Daily (STAND), a parent-teen Motivational Interviewing + Behavior Therapy intervention for adolescents with ADHD. Adolescents with ADHD (N = 225), who were clients at four community mental health agencies, received treatment from 82 therapists. There was double randomization of adolescents and therapists to STAND or Usual Care (UC). Nearly all therapists randomized to STAND completed the training and regularly attended supervision, rating STAND as acceptable and lower burden than UC practices. In the STAND group, MI competence and implementation were lower than in university trials (benchmark range, 19.5% for reflection to question ratio to 83.1% for technical globals). MI integrity in the STAND group was significantly higher than UC across most MITI indices. Content fidelity was adequate in STAND's engagement and skills phases (76.4-85.0%), but not its planning phase (24.4%). Therapists commonly neglected weekly review of goals and home practice and deviated from manualized pace and sequencing of therapy tasks. Learning MI was more challenging for bilingual therapists and therapists with more years of experience. STAND was delivered with higher integrity in earlier sessions and office-based sessions. Discussion identifies future directions for exporting adolescent ADHD interventions to community settings. Patient outcome data for this trial is presented elsewhere. Trial Registration: NCT02694939 www.clinicaltrials.gov.",2020,"Nearly all therapists randomized to STAND completed the training and regularly attended supervision, rating STAND as acceptable and lower burden than UC practices.","['Adolescents with ADHD', 'N\u2009=\xa0225), who were clients at four community mental health agencies, received treatment from 82 therapists', 'adolescent Attention Deficit Hyperactivity Disorder (ADHD', 'adolescents with ADHD']","['Implementing Parent-Teen Motivational Interviewing + Behavior Therapy', 'psychosocial interventions', ""community-based Supporting Teens' Autonomy Daily (STAND), a parent-teen Motivational Interviewing + Behavior Therapy intervention""]","['MI integrity', 'MI competence and implementation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0979506,"Nearly all therapists randomized to STAND completed the training and regularly attended supervision, rating STAND as acceptable and lower burden than UC practices.","[{'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, USA. margaret.sibley@seattlechildrens.org.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Graziano', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bickman', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Stefany J', 'Initials': 'SJ', 'LastName': 'Coxe', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Lourdes M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Fallah', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Ortiz', 'Affiliation': 'Center for Children and Families, Florida International University, Miami, FL, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01105-7']
1014,31485804,"Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial.","PURPOSE


The purpose of this study was to determine the impact of food on gastric pH and the ability of over the counter betaine hydrochloride (BHCl) acid to reacidify gastric pH after food-induced elevations in gastric pH.
METHODS


This open-label cross over clinical study (NCT02758015) included 9 subjects who were randomly assigned to one of 16 possible, 4-period cross-over sequences to determine the impact and relationship of food and gastric pH with acid supplementation. Subjects were administered various doses (1500 mg, 3000 mg and 4500 mg) of betaine hydrochloride (BHCl) to determine the ability of acid supplementation to reacidify gastric pH after the elevation of gastric pH caused by the ingestion of food.
RESULTS


Following the administration of food and the resulting elevation in gastric pH, time to return to baseline gastric pH levels without acid supplementation was 49.7 ± 14.0 min. Administering 4500 mg of BHCl acid in capsules was able to reacidify gastric pH levels back to baseline following the administration of food in approximately 17.3 ± 5.9 min. AUC pH  of each treatment were similar and not statistically different. Mean max pH following the administration of food was 3.20 ± 0.55.
CONCLUSION


The ability of food to elevate and maintain gastric pH levels in the presence of acid supplementation was made evident throughout the study. A 4500 mg dose of BHCl was required to reacidify gastric pH after the administration of food. This study details the difficulty faced by clinicians in dosing a poorly soluble, weakly basic drug to patients receiving acid reducing agents where administration with food is recommended to avoid gastric side effects.
TRIAL REGISTRATION


https://clinicaltrials.gov/ct2/show/NCT02758015.",2019,Administering 4500 mg of BHCl acid in capsules was able to reacidify gastric pH levels back to baseline following the administration of food in approximately 17.3 ± 5.9 min.,['9 subjects who'],"['betaine hydrochloride (BHCl', 'Food, Acid Supplementation and Drug Absorption ', 'hydrochloride (BHCl) acid', 'Administering 4500\xa0mg of BHCl acid', 'BHCl']","['Mean max pH', 'ability of food to elevate and maintain gastric pH levels', 'reacidify gastric pH', 'reacidify gastric pH levels back', 'gastric pH, time to return to baseline gastric pH levels']",[],"[{'cui': 'C0282072', 'cui_str': 'Betaine Hydrochloride'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4517780', 'cui_str': 'Four thousand five hundred'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}]",9.0,0.141432,Administering 4500 mg of BHCl acid in capsules was able to reacidify gastric pH levels back to baseline following the administration of food in approximately 17.3 ± 5.9 min.,"[{'ForeName': 'Dalga D', 'Initials': 'DD', 'LastName': 'Surofchy', 'Affiliation': 'School of Pharmacy, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lynda A', 'Initials': 'LA', 'LastName': 'Frassetto', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leslie Z', 'Initials': 'LZ', 'LastName': 'Benet', 'Affiliation': 'Department of Bioengineering and Therapeutic Sciences, University of California San Francisco, 533 Parnassus Avenue, U-68, San Francisco, 94143-0912, CA, USA. leslie.benet@ucsf.edu.'}]",Pharmaceutical research,['10.1007/s11095-019-2693-5']
1015,32435929,Effectiveness of the clinical decision support tool ESR eGUIDE for teaching medical students the appropriate selection of imaging tests: randomized cross-over evaluation.,"OBJECTIVES


To evaluate ESR eGUIDE-the European Society of Radiology (ESR) e-Learning tool for appropriate use of diagnostic imaging modalities-for learning purposes in different clinical scenarios.
METHODS


This anonymized evaluation was performed after approval of ESR Education on Demand leadership. Forty clinical scenarios were developed in which at least one imaging modality was clinically most appropriate, and the scenarios were divided into sets 1 and 2. These sets were provided to medical students randomly assigned to group A or B to select the most appropriate imaging test for each scenario. Statistical comparisons were made within and across groups.
RESULTS


Overall, 40 medical students participated, and 31 medical students (78%) answered both sets. The number of correctly chosen imaging methods per set in these 31 paired samples was significantly higher when answered with versus without use of ESR eGUIDE (13.7 ± 2.6 questions vs. 12.1 ± 3.2, p = 0.012). Among the students in group A, who first answered set 1 without ESR eGUIDE (11.1 ± 3.2), there was significant improvement when set 2 was answered with ESR eGUIDE (14.3 ± 2.5, p = 0.013). The number of correct answers in group B did not drop when set 2 was answered without ESR eGUIDE (12.4 ± 2.6) after having answered set 1 first with ESR eGUIDE (13.0 ± 2.7, p = 0.66).
CONCLUSION


The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
KEY POINTS


• ESR eGUIDE improved the number of appropriately selected imaging modalities among medical students. • This improvement was also seen in the group of students which first selected imaging tests without ESR eGUIDE. • In the student group which used ESR eGUIDE first, appropriate selection remained stable even without the teaching tool.",2020,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","['40 medical students participated, and 31 medical students (78%) answered both sets', 'teaching medical students']",[],['number of correct answers'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0195978,"The clinical decision support tool ESR eGUIDE is suitable for training medical students in choosing the best radiological imaging modality in typical scenarios, and its use in teaching radiology can thus be recommended.
","[{'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oleaga', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany. marc.dewey@charite.de.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Humboldt-Universität zu Berlin, Freie Universitat Berlin, Charitéplatz 1, 10117, Berlin, Germany.'}]",European radiology,['10.1007/s00330-020-06942-2']
1016,31506853,Psychological Outcomes of a Cognitive Behavioral Therapy for Youth with Inflammatory Bowel Disease: Results of the HAPPY-IBD Randomized Controlled Trial at 6- and 12-Month Follow-Up.,"Youth with inflammatory bowel disease (IBD) often experience psychological difficulties, such as anxiety and depression. This randomized controlled study tested whether a 3-month disease-specific cognitive behavioral therapy (CBT) in addition to standard medical care versus standard medical care only was effective in improving these youth's psychological outcomes. As this study was aimed at prevention, we included 70 youth (10-25 years) with IBD and symptoms of subclinical anxiety and/or depression, and measured psychological outcomes at 6- and 12-month follow-up. In general, participants in both groups showed improvements in anxiety, depression, health-related quality of life, social functioning, coping, and illness perceptions, sustained until 12 months follow-up. Overall, we found no differences between those receiving additional CBT and those receiving standard medical care only. We assume that this can be explained by the perceived low burden (both somatically and psychologically) or heightened awareness of psychological difficulties and IBD. ClinicalTrials.gov NCT02265588.",2020,"In general, participants in both groups showed improvements in anxiety, depression, health-related quality of life, social functioning, coping, and illness perceptions, sustained until 12 months follow-up.","['Youth with inflammatory bowel disease (IBD', 'Youth with Inflammatory Bowel Disease', '70 youth (10-25\xa0years) with IBD and symptoms of subclinical anxiety and/or depression, and measured psychological outcomes at 6- and 12-month follow-up']","['Cognitive Behavioral Therapy', 'disease-specific cognitive behavioral therapy (CBT']","['anxiety, depression, health-related quality of life, social functioning, coping, and illness perceptions']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",70.0,0.0700625,"In general, participants in both groups showed improvements in anxiety, depression, health-related quality of life, social functioning, coping, and illness perceptions, sustained until 12 months follow-up.","[{'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'Stapersma', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, P.O. Box 2060, 3000 CB, Rotterdam, The Netherlands.""}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'van den Brink', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'van der Ende', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, P.O. Box 2060, 3000 CB, Rotterdam, The Netherlands.""}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Szigethy', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Groeneweg', 'Affiliation': 'Department of Pediatrics, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Frederieke H', 'Initials': 'FH', 'LastName': 'de Bruijne', 'Affiliation': 'Department of Gastroenterology, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Manon H J', 'Initials': 'MHJ', 'LastName': 'Hillegers', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, P.O. Box 2060, 3000 CB, Rotterdam, The Netherlands.""}, {'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Escher', 'Affiliation': ""Department of Pediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Elisabeth M W J', 'Initials': 'EMWJ', 'LastName': 'Utens', 'Affiliation': ""Department of Child and Adolescent Psychiatry/Psychology, Erasmus MC-Sophia Children's Hospital, P.O. Box 2060, 3000 CB, Rotterdam, The Netherlands. e.utens@erasmusmc.nl.""}]",Journal of clinical psychology in medical settings,['10.1007/s10880-019-09649-9']
1017,32176306,"Association of a Lay Health Worker Intervention With Symptom Burden, Survival, Health Care Use, and Total Costs Among Medicare Enrollees With Cancer.","Importance


Undertreated patient symptoms require approaches that improve symptom burden.
Objective


To determine the association of a lay health worker-led symptom screening and referral intervention with symptom burden, survival, health care use, and total costs among Medicare Advantage enrollees with a new diagnosis of solid or hematologic malignant neoplasms.
Design, Setting, and Participants


This quality improvement study conducted at 9 community oncology practices from November 1, 2016, to October 31, 2018, compared newly diagnosed Medicare Advantage enrollees with solid or hematologic malignant neoplasms with patients diagnosed and treated 1 year prior. Analysis was conducted from August 1, 2019, to January 11, 2020.
Interventions


Usual care augmented by a lay health worker trained to screen symptoms and refer patients to palliative care and behavioral medicine.
Main Outcomes and Measures


The primary outcome was change in symptoms using the Edmonton Symptom Assessment Scale and the 9-item Patient Health Questionnaire at baseline and 6 and 12 months after enrollment. Secondary outcomes were between-group comparison of survival, 12-month health care use, and costs.
Results


Among 425 patients in the intervention group and 407 patients in the control group, the mean (SD) age was 78.8 (8.3) years, 345 (41.5%) were female, and 407 (48.9%) were non-Hispanic white. Patients in the intervention group experienced a lower symptom burden as measured by the Edmonton Symptom Assessment Scale score over time compared with patients in the control group (mean [SD] difference, -1.9 [14.2]; 95% CI, -3.77 to -0.19; P = .01 for the intervention group and 2.32 [17.7]; 95% CI, 0.47 to 4.19; P = .02 for the control group). Similar findings were noted in 9-item Patient Health Questionnaire depression scores (mean [SD] difference, -0.63 [3.99]; 95% CI, -1.23 to -0.028; P = .04 for the intervention group and 1.67 [5.49]; 95% CI, 0.95 to 2.37; P = .01 for the control group). Patients in the intervention group compared with patients in the control group had fewer mean (SD) inpatient visits (0.54 [0.77]; 95% CI, 0.47-0.61 vs 0.72 [1.12]; 95% CI, 0.61-0.83; P = .04) and emergency department visits (0.43 [0.76]; 95% CI, 0.36-0.50 vs 0.57 [1.00]; 95% CI, 0.48-0.67; P = .002) per 1000 patients per year and lower total costs (median, $17 869 [interquartile range, $6865-$32 540] vs median, $18 473 [interquartile range, $6415-$37 910]; P = .02). A total of 180 patients in the intervention group and 189 patients in the control group died within 12 months. Among those who died, patients in the intervention group had greater hospice use (125 of 180 [69.4%] vs 79 of 189 [41.8%]; odds ratio, 3.16; 95% CI, 2.13-4.69; P < .001), fewer mean (SD) emergency department and hospital visits (emergency department: 0.10 [0.30]; 95% CI, 0.06-0.14 vs 0.30 [0.46]; 95% CI, 0.24-0.38; P = .001; hospital: 0.27 [0.44]; 95% CI, 0.21-0.34 vs 0.43 [0.82]; 95% CI, 0.32-0.55; P = .02), and lower costs (median, $3602 [interquartile range, $1076-$9436] vs median, $12 726 [interquartile range, $5259-$22 170]; P = .002), but there was no significant difference in inpatient deaths (18 of 180 [10.0%] vs 30 of 189 [15.9%]; P = .14).
Conclusions and Relevance


This study suggests that a lay health worker-led intervention may be one way to improve burdensome and costly care.",2020,"Patients in the intervention group experienced a lower symptom burden as measured by the Edmonton Symptom Assessment Scale score over time compared with patients in the control group (mean [SD] difference, -1.9 [14.2]; 95% CI, -3.77 to -0.19; P = .01 for the intervention group and 2.32 [17.7]; 95% CI, 0.47 to 4.19; P = .02 for the control group).","['Medicare Advantage enrollees with a new diagnosis of solid or hematologic malignant neoplasms', '9 community oncology practices from November 1, 2016, to October 31, 2018, compared newly diagnosed Medicare Advantage enrollees with solid or hematologic malignant neoplasms with patients diagnosed and treated 1 year prior', '180 patients in the intervention group and 189 patients in the control group died within 12 months', 'Medicare Enrollees With Cancer', '425 patients in the intervention group and 407 patients in the control group, the mean (SD) age was 78.8 (8.3) years, 345 (41.5%) were female, and 407 (48.9%) were non-Hispanic white']","['lay health worker-led symptom screening and referral intervention', 'Interventions\n\n\nUsual care augmented by a lay health worker trained to screen symptoms and refer patients to palliative care and behavioral medicine']","['Edmonton Symptom Assessment Scale score over time', 'lower costs', 'mean (SD) inpatient visits', 'greater hospice use', 'survival, 12-month health care use, and costs', '9-item Patient Health Questionnaire depression scores', 'total costs', 'inpatient deaths', 'Survival, Health Care Use, and Total Costs', 'lower symptom burden', 'change in symptoms using the Edmonton Symptom Assessment Scale and the 9-item Patient Health Questionnaire', 'emergency department visits', 'mean (SD) emergency department and hospital visits']","[{'cui': 'C2713369', 'cui_str': 'Medicare Advantage'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis (observable entity)'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0004937', 'cui_str': 'Behavioral Medicine'}]","[{'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0019947', 'cui_str': 'Hospices'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.238954,"Patients in the intervention group experienced a lower symptom burden as measured by the Edmonton Symptom Assessment Scale score over time compared with patients in the control group (mean [SD] difference, -1.9 [14.2]; 95% CI, -3.77 to -0.19; P = .01 for the intervention group and 2.32 [17.7]; 95% CI, 0.47 to 4.19; P = .02 for the control group).","[{'ForeName': 'Manali I', 'Initials': 'MI', 'LastName': 'Patel', 'Affiliation': 'Division of Oncology, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ramirez', 'Affiliation': 'CareMore Health, Cerritos, California.'}, {'ForeName': 'Richy', 'Initials': 'R', 'LastName': 'Agajanian', 'Affiliation': 'The Oncology Institute of Hope and Innovation, Downy, California.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Agajanian', 'Affiliation': 'The Oncology Institute of Hope and Innovation, Downy, California.'}, {'ForeName': 'Tumaini', 'Initials': 'T', 'LastName': 'Coker', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington.""}]",JAMA network open,['10.1001/jamanetworkopen.2020.1023']
1018,31511891,Recurrent Hemispheric Stroke Syndromes in Symptomatic Atherosclerotic Internal Carotid Artery Occlusions: The Carotid Occlusion Surgery Study Randomized Trial.,"BACKGROUND


There are limited data on outcomes of extracranial-intracranial (EC-IC) bypass in patients with recurrent hemispheric syndromes due to atherosclerotic internal carotid artery occlusion (AICAO).
OBJECTIVE


To compare clinical outcomes and efficacy of EC-IC bypass surgery in patients with and without recurrent hemispheric syndromes associated with AICAO in the Carotid Occlusion Surgery Study (COSS).
METHODS


In patients enrolled in the COSS trial, we compared baseline characteristics and clinical outcomes for participants with (rHEMI+) and without recurrent hemispheric ischemia (rHEMI-) prior to randomization into surgical vs medical groups. The primary outcome was all stroke and death from randomization through 30 d and ipsilateral ischemic stroke within 2 yr.
RESULTS


Of 195 randomized participants, 100 were rHEMI+ (50 in each group). Baseline characteristics between rHEMI+ and rHEMI- participants were similar except rHEMI+ were more likely to have had previous stroke prior to randomization (61% vs 20%, P < .01) and to have TIA as the entry event (59% vs 21%, P < .01). All primary endpoints were ipsilateral ischemic strokes. There were no significant differences in occurrence of the primary endpoint between nonsurgical and surgical participants in rHEMI+ (26.3% vs 22.4%, P = .660) and rHEMI- (18.9% vs 19.5%, P = .943). For nonsurgical participants, there was no significant difference in the primary endpoint for rHEMI+ vs rHEMI- patients (P = .410).
CONCLUSION


Patients with recurrent hemispheric stroke syndromes enrolled in the COSS trial did not show benefit from EC-IC bypass compared to medical treatment. Early aggressive risk factor measures should be prioritized to reduce recurrent strokes in these patients.",2020,"For nonsurgical participants, there was no significant difference in the primary endpoint for rHEMI+ vs rHEMI- patients (P = .410).
","['participants with (rHEMI+) and without recurrent hemispheric ischemia (rHEMI-) prior to randomization into surgical vs medical groups', 'patients with recurrent hemispheric syndromes due to atherosclerotic internal carotid artery occlusion (AICAO', 'patients with and without recurrent hemispheric syndromes associated with AICAO in the Carotid Occlusion Surgery Study (COSS', 'Symptomatic Atherosclerotic Internal Carotid Artery Occlusions', 'Of 195 randomized participants, 100 were rHEMI', 'Patients with recurrent hemispheric stroke syndromes']","['extracranial-intracranial (EC-IC) bypass', 'EC-IC bypass', 'EC-IC bypass surgery']","['recurrent strokes', 'rHEMI', 'ipsilateral ischemic strokes', 'stroke and death from randomization through 30 d and ipsilateral ischemic stroke within 2 yr']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0265101', 'cui_str': 'Carotid artery obstruction (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1263853', 'cui_str': 'Paralytic stroke (disorder)'}]","[{'cui': 'C0580586', 'cui_str': 'Extracranial (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1536078', 'cui_str': 'Bypass surgery'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]",195.0,0.220234,"For nonsurgical participants, there was no significant difference in the primary endpoint for rHEMI+ vs rHEMI- patients (P = .410).
","[{'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Nahab', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Haseeb A', 'Initials': 'HA', 'LastName': 'Rahman', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Srikant', 'Initials': 'S', 'LastName': 'Rangaraju', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Barrow', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Cawley', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Grubb', 'Affiliation': 'Charleston, South Carolina.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Harold P', 'Initials': 'HP', 'LastName': 'Adams', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Tom O', 'Initials': 'TO', 'LastName': 'Videen', 'Affiliation': 'Santa Fe, New Mexico.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Powers', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}]",Neurosurgery,['10.1093/neuros/nyz352']
1019,32127657,Plerixafor combined with standard regimens for hematopoietic stem cell mobilization in pediatric patients with solid tumors eligible for autologous transplants: two-arm phase I/II study (MOZAIC).,"This study (NCT01288573) investigated plerixafor's safety and efficacy in children with cancer. Stage 1 investigated the dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor + standard mobilization (G-CSF ± chemotherapy). The stage 2 primary endpoint was successful mobilization (doubling of peripheral blood CD34+ cell count in the 24 h prior to first apheresis) in patients treated with plerixafor + standard mobilization vs. standard mobilization alone. In stage 1, three patients per age group (2-<6, 6-<12, and 12-<18 years) were treated at each dose level (160, 240, and 320 µg/kg). Based on PK and PD data, the dose proposed for stage 2 was 240 µg/kg (patients 1-<18 years), in which 45 patients were enrolled (30 plerixafor arm, 15 standard arm). Patient demographics and characteristics were well balanced across treatment arms. More patients in the plerixafor arm (24/30, 80%) met the primary endpoint of successful mobilization than in the standard arm (4/14, 28.6%, p = 0.0019). Adverse events reported as related to study treatment were mild, and no new safety concerns were identified. Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.",2020,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"['children with cancer', 'pediatric patients with solid tumors eligible for autologous transplants', 'pediatric cancer patients']","['Plerixafor combined with standard regimens', 'Plerixafor', 'plerixafor']","['successful mobilization', 'successful mobilization (doubling of peripheral blood CD34+ cell count', 'Adverse events', 'dosage, pharmacokinetics (PK), pharmacodynamics (PD), and safety of plerixafor\u2009+\u2009standard mobilization', 'tolerated and efficacious']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}]","[{'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",45.0,0.045626,Plerixafor + standard G-CSF ± chemotherapy mobilization was generally well tolerated and efficacious when used to mobilize CD34+ cells in pediatric cancer patients.,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women's and Children's Hospital, Birmingham, UK. bruce.morland@nhs.net.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kepak', 'Affiliation': 'University Hospital Brno and ICRC/St. Anna University Hospital, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Dallorso', 'Affiliation': 'IRCCS Giannina Gaslini, Genova, Italy.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Sevilla', 'Affiliation': 'Hospital Infantil Universitario Niño Jesus, FIB HIUNJ, CIBERER, Madrid, Spain.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': 'Royal Hospital for Children, Glasgow, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Luksch', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Yaniv', 'Affiliation': ""Schneider Children's Medical Center of Israel, Tel Aviv University, Petah Tikva, Israel.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bader', 'Affiliation': 'Universitätsklinikum Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Rößler', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Gianni', 'Initials': 'G', 'LastName': 'Bisogno', 'Affiliation': ""Department for Women's and Children's Health, University of Padua, Padua, Italy.""}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Maecker-Kolhoff', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': ""University Children's Hospital, Tübingen, Germany.""}, {'ForeName': 'C Michel', 'Initials': 'CM', 'LastName': 'Zwaan', 'Affiliation': ""Erasmus MC-Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sumerauer', 'Affiliation': 'Faculty Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Gergely', 'Initials': 'G', 'LastName': 'Kriván', 'Affiliation': 'United St Istvan and St Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bernard', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Doyle', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': ""IRCCS Bambino Gesù Children's Hospital, Rome, Italy.""}]",Bone marrow transplantation,['10.1038/s41409-020-0836-2']
1020,32433194,"Comparing the Efficiency, Radiation Exposure, and Accuracy Using C-Arm versus O-Arm With 3D Navigation in Placement of Transiliac-Transsacral and Iliosacral Screws: A Cadaveric Study Evaluating an Early Career Surgeon.","OBJECTIVES


To compare the efficiency, radiation exposure to surgeon and patient, and accuracy of C-arm versus O-arm with navigation in the placement of transiliac-transsacral and iliosacral screws by an orthopaedic trauma fellow, for a surgeon early in practice.
METHODS


Twelve fresh frozen cadavers were obtained. Preoperative computed tomography scans were reviewed to assess for safe corridors in the S1 and S2 segments. Iliosacral screws were assigned to the S1 segment in dysmorphic pelvises. Screws were randomized to modality and laterality. An orthopaedic trauma fellow placed all screws. Time of procedure and radiation exposure to the cadaver and surgeon were recorded. Three fellowship-trained orthopaedic trauma surgeons rated the safety of each screw on postoperative computed tomography scan.
RESULTS


Six normal and 6 dysmorphic pelvises were identified. Eighteen transiliac-transsacral screws and 6 iliosacral screws were distributed evenly between C-arm and O-arm. Average operative duration per screw was significantly shorter using C-arm compared with O-arm (15.7 minutes ± 6.1 vs. 23.7 ± 8.5, P = 0.014). Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10 rads vs. 0.32 × 10, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001). Two S2 transiliac-transsacral screws (1 C-arm and 1 O-arm) were categorized as unsafe based on scoring. There was no difference in screw accuracy between modalities.
CONCLUSIONS


A difference in accuracy between modalities could not be elucidated, whereas efficiency was improved with utilization of C-arm, with statistical significance. A statistically significant increase in radiation exposure to the surgeon using C-arm was found, which may be clinically significant over a career. The results of this study can be extrapolated to a fellow or surgeon early in practice. The decision between use of these modalities will vary depending on surgeon preference and hospital resources.",2020,"Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10 rads vs. 0.32 × 10, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001).","['Eighteen transiliac-transsacral screws and 6 iliosacral screws', 'Twelve fresh frozen cadavers were obtained']","['C-Arm versus O-Arm', 'C-arm versus O-arm with navigation', '3D Navigation', 'Preoperative computed tomography scans']","['radiation exposure', 'screw accuracy', 'amount of radiation', 'Average operative duration per screw']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0589469', 'cui_str': 'Transsacral approach'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",12.0,0.0365087,"Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10 rads vs. 0.32 × 10, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001).","[{'ForeName': 'Edgar T', 'Initials': 'ET', 'LastName': 'Araiza', 'Affiliation': 'Department of Orthopaedic Surgery, Wake Forest Baptist Medical Center, Winston Salem, NC.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Medda', 'Affiliation': ''}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Plate', 'Affiliation': ''}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Marquez-Lara', 'Affiliation': ''}, {'ForeName': 'Amy P', 'Initials': 'AP', 'LastName': 'Trammell', 'Affiliation': ''}, {'ForeName': 'Fernando S', 'Initials': 'FS', 'LastName': 'Aran', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lara', 'Affiliation': ''}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Danelson', 'Affiliation': ''}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Halvorson', 'Affiliation': ''}, {'ForeName': 'Eben A', 'Initials': 'EA', 'LastName': 'Carroll', 'Affiliation': ''}, {'ForeName': 'Holly T', 'Initials': 'HT', 'LastName': 'Pilson', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001724']
1021,30904515,Tactile Precision Remains Intact When Acute Neck Pain Is Induced.,"A growing body of evidence suggests that chronic pain is associated with perceptual changes, such as impaired tactile acuity and laterality judgements. A recent study on low back pain showed that tactile acuity was decreased immediately after acute pain induction. Biologically, acute pain should lead to enhanced rather than disruptive changes in tactile acuity to meaningfully respond to potentially damaging nociceptive stimuli. In this double-blinded experiment, 30 healthy volunteers attended 3 experimental sessions (injection, sham injection, and control condition) separated by 1 week each, to investigate the effect of acute nociception on tactile precision and laterality judgements. In the real injection condition, acute pain was induced by hypertonic saline solution injected into the mid portion of the trapezius muscle. Tactile acuity (2-point discrimination and an estimation task) and laterality judgements were measured before and during pain perception. In the sham condition, the injection was mimicked by a sham procedure (without piercing the skin), and in the control condition no intervention took place. Results showed that tactile acuity remained intact (P = .92), indicating that experimentally induced neck pain did not affect tactile precision. The time needed to complete the laterality judgement task improved over time in all conditions, reflecting a learning effect (P = .05). We conclude that acute neck pain does not result in perceptual distortions, possibly reflecting a higher protection demand for the neck, a body region in close anatomic proximity to neural centers responsible for vital functions. These data-in the context of existing evidence-indicates that tactile acuity may respond differently to noxious stimulation in different anatomic regions. PERSPECTIVE: In this study, a sensory adaptation to acute neck pain was investigated. It was found that experimental neck pain did not elicit changes in the sensory axis, leaving tactile acuity intact in otherwise healthy participants. These data support site-specific sensory adaptation to pain.",2019,"Results showed that tactile acuity remained intact (P = .92), indicating that experimentally induced neck pain did not affect tactile precision.",['30 healthy volunteers'],['hypertonic saline solution'],"['tactile acuity', 'tactile precision', 'time needed to complete the laterality judgement task', 'neck pain', 'acute pain', 'tactile precision and laterality judgements', 'Tactile acuity (2-point discrimination and an estimation task) and laterality judgements']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332304', 'cui_str': 'Laterality (attribute)'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}]",30.0,0.280813,"Results showed that tactile acuity remained intact (P = .92), indicating that experimentally induced neck pain did not affect tactile precision.","[{'ForeName': 'Wacław M', 'Initials': 'WM', 'LastName': 'Adamczyk', 'Affiliation': 'Laboratory of Pain Research, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland; Department of Orthopaedic and Trauma Surgery, Pain & Exercise Research Luebeck, University of Luebeck, Luebeck, Germany; Department of Kinesiotherapy and Special Methods in Physiotherapy, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland. Electronic address: w.adamczyk@awf.katowice.pl.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Budzisz', 'Affiliation': 'Department of Pedagogy and Psychology, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Saulicz', 'Affiliation': 'Regional Specialised Hospital No. 4, Bytom, Poland.'}, {'ForeName': 'Tibor M', 'Initials': 'TM', 'LastName': 'Szikszay', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Pain & Exercise Research Luebeck, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Saulicz', 'Affiliation': 'Department of Kinesiotherapy and Special Methods in Physiotherapy, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Pain & Exercise Research Luebeck, University of Luebeck, Luebeck, Germany; Department of Kinesiotherapy and Special Methods in Physiotherapy, The Jerzy Kukuczka Academy of Physical Education, Katowice, Poland; Department of Systems Neuroscience, Center for Experimental Medicine, University Medical Center Hamburg-Eppendorf, Germany.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.03.006']
1022,32425006,Efficacy of internet-based integrated intervention on depression and anxiety symptoms in patients with COVID-19.,"Public health crises, such as the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) since Dec. 2019, are widely acknowledged as severe traumatic events that impose threats not only because of physical concerns but also because of the psychological distress of infected patients. We designed an internet-based integrated intervention and evaluated its efficacy on depression and anxiety symptoms in patients infected by SARS-CoV-2.",2020,We designed an internet-based integrated intervention and evaluated its efficacy on depression and anxiety symptoms in patients infected by SARS-CoV-2.,"['patients with COVID-19', 'patients infected by SARS-CoV-2']",['internet-based integrated intervention'],['depression and anxiety symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0207417,We designed an internet-based integrated intervention and evaluated its efficacy on depression and anxiety symptoms in patients infected by SARS-CoV-2.,"[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wei', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Bo-Chao', 'Initials': 'BC', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Shao-Jia', 'Initials': 'SJ', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jian-Bo', 'Initials': 'JB', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Xiao-Yi', 'Initials': 'XY', 'LastName': 'Zhou', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Chan-Chan', 'Initials': 'CC', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jing-Kai', 'Initials': 'JK', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Jin-Wen', 'Initials': 'JW', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Shu-Guang', 'Initials': 'SG', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}, {'ForeName': 'Shao-Hua', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.'}]",Journal of Zhejiang University. Science. B,['10.1631/jzus.B2010013']
1023,32103495,Omega-3 PUFA and aspirin as adjuncts to periodontal debridement in patients with periodontitis and type 2 diabetes mellitus: Randomized clinical trial.,"BACKGROUND


Supplementation with omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA) have been proposed as a host modulation regimen to control chronic inflammatory diseases. The aim of this study was to investigate the clinical and immunological impact of orally administered ω-3 PUFA and ASA as adjuncts to periodontal debridement for the treatment of periodontitis in patients type 2 diabetes.
METHODS


Seventy-five patients (n = 25/group) were randomly assigned to receive placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) after periodontal debridement (test group [TG]1), or ω-3 PUFA + ASA (3 g of fish oil/d + 100 mg ASA/d for 2 months) before periodontal debridement (TG2). Periodontal parameters and GCF were collected at baseline (t0), 3 months after periodontal debridement and ω-3 PUFA + ASA or placebo for TG1 and CG (t1), after ω-3 PUFA + ASA (before periodontal debridement) for TG2 (t1), and 6 months after periodontal debridement (all groups) (t2). GCF was analyzed for cytokine levels by multiplex ELISA.
RESULTS


Ten patients (40%) in TG1 and nine patients (36%) in TG2 achieved the clinical endpoint for treatment (less than or equal to four sites with probing depth ≥ 5 mm), as opposed to four (16%) in CG. There was clinical attachment gain in moderate and deep pockets for TG1. IFN-γ and interleukin (IL)-8 levels decreased over time for both test groups. IL-6 levels were lower for TG1. HbA1c levels reduced for TG1.
CONCLUSION


Adjunctive ω-3 and ASA after periodontal debridement provides clinical and immunological benefits to the treatment of periodontitis in patients with type 2 diabetes.",2020,IFN-γ and IL-8 levels decreased over time for both test groups.,"['patients with periodontitis and type 2 diabetes mellitus', 'patients with type 2 diabetes', 'Seventy-five patients (n = 25/group', 'patients type 2 diabetes']","['Omega-3 PUFA and aspirin', 'ω-3 PUFA + ASA or placebo', 'ω-3 PUFA and ASA', 'placebo and periodontal debridement (CG), ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) after periodontal debridement (Test Group [TG]1), or ω-3 PUFA + ASA (3g of fish oil/day + 100mg ASA/day for 2 months) before periodontal debridement (TG2', 'omega-3 polyunsaturated fatty acids (ω-3 PUFA) and low-dose aspirin (ASA']","['clinical attachment gain', 'HbA1c levels', 'IFN-γ and IL-8 levels', 'IL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.114601,IFN-γ and IL-8 levels decreased over time for both test groups.,"[{'ForeName': 'Nidia C', 'Initials': 'NC', 'LastName': 'Castro Dos Santos', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Naira M R B', 'Initials': 'NMRB', 'LastName': 'Andere', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Cássia F', 'Initials': 'CF', 'LastName': 'Araujo', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'de Marco', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Alpdogan', 'Initials': 'A', 'LastName': 'Kantarci', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Van Dyke', 'Affiliation': 'Center for Clinical and Translational Research, The Forsyth Institute, Cambridge, Massachusetts, United States.'}, {'ForeName': 'Mauro P', 'Initials': 'MP', 'LastName': 'Santamaria', 'Affiliation': 'Division of Periodontics, Unesp - São Paulo State University, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.19-0613']
1024,31161692,"A 24-week, randomized, double-blind, active-controlled clinical trial comparing bexagliflozin with sitagliptin as an adjunct to metformin for the treatment of type 2 diabetes in adults.","AIM


To compare the relative safety and effectiveness of bexagliflozin and sitagliptin as adjuncts to metformin for the treatment of adults with type 2 diabetes.
METHODS


Participants (n = 386) were randomized to receive bexagliflozin (20 mg) or sitagliptin (100 mg) in addition to their existing doses of metformin. The primary endpoint was the non-inferiority of bexagliflozin to sitagliptin for change in HbA1c from baseline to week 24. Changes from baseline to week 24 in fasting plasma glucose (FPG), body mass (in subjects with baseline body mass index ≥25 kg m -2  ) and systolic blood pressure (SBP) were secondary endpoints.
RESULTS


The mean change from baseline to week 24 in HbA1c was -0.74 (95% CI -0.86%, -0.62%) in the bexagliflozin arm and -0.82% (95% CI -0.93%, -0.71%) in the sitagliptin arm, establishing non-inferiority. The changes from baseline FPG, body mass and SBP were -1.82 mmol L -1  , -3.35 kg and -4.23 mmHg in the bexagliflozin arm and -1.45 mmol L -1  , -0.81 kg and -1.90 mmHg in the sitagliptin arm, respectively. These differences were significant for the first two measures (one-sided P = 0.0123, P < 0.0001 and P = 0.0276, respectively.) Adverse events were experienced by 47.1% of subjects in the bexagliflozin arm and 56.0% of subjects taking sitagliptin. Serious adverse events affected 3.7% of subjects in the bexagliflozin arm and 2.1% of subjects in the sitagliptin arm.
CONCLUSIONS


Bexagliflozin was non-inferior to sitagliptin and provided benefits over sitagliptin in FPG and body mass. Adverse event incidences in the two arms were similar.",2019,The primary endpoint was the non-inferiority of bexagliflozin to sitagliptin for change in HbA1c from baseline to week 24.,"['adults with type 2 diabetes', 'Participants (n = 386', 'type 2 diabetes in adults']","['Bexagliflozin', 'metformin', 'bexagliflozin', 'bexagliflozin with sitagliptin', 'bexagliflozin and sitagliptin', 'sitagliptin']","['Adverse events', 'Adverse event incidences', 'systolic blood pressure (SBP', 'non-inferiority of bexagliflozin to sitagliptin for change in HbA1c', 'fasting plasma glucose (FPG), body mass', 'Serious adverse events', 'baseline FPG, body mass and SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",386.0,0.0908454,The primary endpoint was the non-inferiority of bexagliflozin to sitagliptin for change in HbA1c from baseline to week 24.,"[{'ForeName': 'Yuan-Di', 'Initials': 'YD', 'LastName': 'Halvorsen', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Lock', 'Affiliation': 'Diabetes Center of Excellence, Department of Medicine, University of Massachusetts, Worcester, Massachusetts.'}, {'ForeName': 'Wenjiong', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Hopkins Consulting LLC, Philadelphia, Pennsylvania.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'Syneos Health, Blue Bell, Pennsylvania.'}, {'ForeName': 'Mason W', 'Initials': 'MW', 'LastName': 'Freeman', 'Affiliation': 'Translational Medicine Group, Center for Computational and Integrative Biology, Massachusetts General Hospital, Boston, Massachusetts.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13801']
1025,30561610,Persistent arterial wall inflammation in patients with elevated lipoprotein(a) despite strong low-density lipoprotein cholesterol reduction by proprotein convertase subtilisin/kexin type 9 antibody treatment.,"AIMS


Subjects with lipoprotein(a) [Lp(a)] elevation have increased arterial wall inflammation and cardiovascular risk. In patients at increased cardiovascular risk, arterial wall inflammation is reduced following lipid-lowering therapy by statin treatment or lipoprotein apheresis. However, it is unknown whether lipid-lowering treatment in elevated Lp(a) subjects alters arterial wall inflammation. We evaluated whether evolocumab, which lowers both low-density lipoprotein cholesterol (LDL-C) and Lp(a), attenuates arterial wall inflammation in patients with elevated Lp(a).
METHODS AND RESULTS


In this multicentre, randomized, double-blind, placebo-controlled study, 129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0 [155.5-301.5] nmol/L [80.0 (62.5-121.0) mg/dL]; mean [standard deviation (SD)] LDL-C 3.7 [1.0] mmol/L [144.0 (39.7) mg/dL]; National Cholesterol Education Program high risk, 25.6%} were randomized to monthly subcutaneous evolocumab 420 mg or placebo. Compared with placebo, evolocumab reduced LDL-C by 60.7% [95% confidence interval (CI) 65.8-55.5] and Lp(a) by 13.9% (95% CI 19.3-8.5). Among evolocumab-treated patients, the Week 16 mean (SD) LDL-C level was 1.6 (0.7) mmol/L [60.1 (28.1) mg/dL], and the median (IQR) Lp(a) level was 188.0 (140.0-268.0) nmol/L [75.2 (56.0-107.2) mg/dL]. Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR)] in the index vessel (left carotid, right carotid, or thoracic aorta) was assessed by 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography. Week 16 index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%) [treatment difference -3.0% (95% CI -7.4% to 1.4%); P = 0.18].
CONCLUSION


Evolocumab treatment in patients with median baseline Lp(a) 200.0 nmol/L led to a large reduction in LDL-C and a small reduction in Lp(a), resulting in persistent elevated Lp(a) levels. The latter may have contributed to the unaltered arterial wall inflammation.",2019,index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%),"['patients with median baseline Lp(a', '129 patients {median [interquartile range (IQR)]: age 60.0 [54.0-67.0] years, Lp(a) 200.0', 'Aims\n\n\nSubjects with lipoprotein(a) [Lp(a', 'patients with elevated lipoprotein(a', 'patients with elevated Lp(a']","['subcutaneous evolocumab 420\u2009mg or placebo', 'dL', 'placebo']","['cardiovascular risk, arterial wall inflammation', 'index vessel MDS TBR', 'arterial wall inflammation and cardiovascular risk', 'mean (SD) LDL-C level', 'low-density lipoprotein cholesterol (LDL-C) and Lp(a', 'median (IQR) Lp(a) level', 'Arterial wall inflammation [most diseased segment target-to-background ratio (MDS TBR', 'LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}]","[{'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0507850', 'cui_str': 'Structure of wall of artery (body structure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",129.0,0.615669,index vessel MDS TBR was not significantly altered with evolocumab (-8.3%) vs. placebo (-5.3%),"[{'ForeName': 'Lotte C A', 'Initials': 'LCA', 'LastName': 'Stiekema', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Simone L', 'Initials': 'SL', 'LastName': 'Verweij', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Helina', 'Initials': 'H', 'LastName': 'Kassahun', 'Affiliation': 'Department of Clinical Development, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Wasserman', 'Affiliation': 'Department of Clinical Development, Amgen Inc., One Amgen Center Drive Thousand Oaks, CA, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Division of Cardiovascular Medicine, TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Fenwood Road, Boston, MA, USA.""}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Mani', 'Affiliation': 'Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl, New York, NY, USA.'}, {'ForeName': 'Zahi A', 'Initials': 'ZA', 'LastName': 'Fayad', 'Affiliation': 'Translational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Pl, New York, NY, USA.'}]",European heart journal,['10.1093/eurheartj/ehy862']
1026,31501493,Effect of angiotensin II receptor blocker and salt supplementation on short-term blood pressure variability in type 2 diabetes.,"High blood pressure variability (BPV) has been associated with increased cardiovascular (CV) risk. The effect of dietary salt and renin-angiotensin-aldosterone system (RAAS) activity on short-term BPV in type 2 diabetes mellitus (T2DM) is not well characterised. We aimed to determine the effect of dietary salt (sodium chloride, NaCl) supplementation on 24-h mean arterial BPV (24hBPV) during angiotensin II receptor blocker (telmisartan) use and to evaluate the effects of age, sex, plasma renin activity (PRA) and serum aldosterone on 24hBPV. In a randomised, double-blind, crossover study, patients with T2DM (n = 28), treated with telmisartan received NaCl (100 mmol/24 h) or placebo capsules during 2 weeks of telmisartan. Following a 6-week washout, the protocol was repeated in reverse. 24hBPV was evaluated as a co-efficient of variation [CV (%) = mean/standard deviation] × 100). Twenty-four hour urinary sodium excretion, ambulatory BP and biochemical tests were performed at each phase. Results were analysed using a linear mixed model to generate predicted values for 24hBPV. Predicted 24hBPV was higher with telmisartan vs baseline (p = 0.01), with a trend towards reduced 24hBPV with salt (p = 0.052). Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011). In patients with T2DM, predicted 24hBPV increased from baseline with telmisartan, but there was no additional increase in predicted 24hBPV with salt supplementation. This suggests that in the short-term, salt supplementation has no apparent deleterious effects on 24hBPV. Long-term studies are required to evaluate the effect of 24hBPV on CV outcomes in patients with T2DM.",2020,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","['patients with T2DM (n\u2009=\u200928), treated with', 'type 2 diabetes', 'type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['telmisartan', 'telmisartan received NaCl', '24hBPV', 'dietary salt (sodium chloride, NaCl) supplementation', 'placebo', 'angiotensin II receptor blocker and salt supplementation', 'angiotensin II receptor blocker (telmisartan', 'dietary salt and renin-angiotensin-aldosterone system (RAAS) activity']","['urinary sodium excretion, ambulatory BP and biochemical tests', 'Predicted 24hBPV', 'cardiovascular (CV) risk', '24hBPV', 'CV outcomes', 'High blood pressure variability (BPV', 'short-term blood pressure variability', 'PRA', '24-h mean arterial BPV (24hBPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0546638,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Moran', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Libianto', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baqar', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Callaghan"", 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jerums', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia. elif.ekinci@unimelb.edu.au.'}]",Journal of human hypertension,['10.1038/s41371-019-0238-3']
1027,31952625,"Effectiveness of a brief motivation enhancing intervention on treatment initiation, treatment retention and abstinence: Results from a multi-site cluster-randomized trial.","The aim of this study was to test the effectiveness of a brief motivational enhancing intervention (MEI) as an add-on to supervision-as-usual (SAU) in reducing time to treatment initiation in offenders with substance use disorders (SUDs) under probation supervision. We also tested the effectiveness in enhancing treatment retention and abstinence of primary substance rates. The study was designed as a multi-site, cluster randomized trial (CRT) in six addiction probation offices. We randomized 73 probation officers (37 to intervention, 36 to control) and followed 220 substance-abusing repeat offenders during their supervision (111 intervention, 109 control). Individualized SAU was compared with supervision with MEI. We report time to treatment initiation, treatment retention rate during the 12 months follow-up, and primary substance abstinence rate in the 30 days before follow-up. Results show that time to treatment initiation (χ2(1) = 1.817, p = .178), and the proportion of treatment retention (OR = 1.980, p = .213) and primary substance abstinence (OR = 0.945, p = .886) did not significantly differ between offenders that received SAU plus MEI and those that received SAU at 12 months follow-up. Our findings provide no evidence that supervision plus a brief manual-base MEI is more effective than SAU.",2020,"1.817, p = .178), and the proportion of treatment retention (OR = 1.980, p = .213) and primary substance abstinence (OR = 0.945, p = .886) did not significantly differ between offenders that received SAU plus MEI and those that received SAU at 12 months follow-up.","['six addiction probation offices', '73 probation officers (37 to intervention, 36 to control) and followed 220 substance-abusing repeat offenders during their supervision (111 intervention, 109 control', 'offenders with substance use disorders (SUDs) under probation supervision']","['motivational enhancing intervention (MEI', 'Individualized SAU', 'brief motivation enhancing intervention', 'supervision-as-usual (SAU', 'SAU']","['primary substance abstinence', 'proportion of treatment retention', 'substance abstinence rate', 'time to treatment initiation (χ2(1)\xa0']","[{'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0401946', 'cui_str': 'Probation officer (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0740858', 'cui_str': 'Substance Abuse'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]",6.0,0.105448,"1.817, p = .178), and the proportion of treatment retention (OR = 1.980, p = .213) and primary substance abstinence (OR = 0.945, p = .886) did not significantly differ between offenders that received SAU plus MEI and those that received SAU at 12 months follow-up.","[{'ForeName': 'Lilach', 'Initials': 'L', 'LastName': 'Shaul', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Institute for Addiction Research, Amsterdam, the Netherlands. Electronic address: l.shaul@amsterdamumc.nl.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'de Waal', 'Affiliation': 'Arkin Mental Health Care, Department of Research, Amsterdam, the Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Institute for Addiction Research, Amsterdam, the Netherlands; Arkin Mental Health Care, Department of Research, Amsterdam, the Netherlands; Trimbos institute, Netherlands Institute of Mental Health and Addiction, Utrecht, the Netherlands.'}, {'ForeName': 'Maarten W J', 'Initials': 'MWJ', 'LastName': 'Koeter', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Institute for Addiction Research, Amsterdam, the Netherlands.'}, {'ForeName': 'Gerard M', 'Initials': 'GM', 'LastName': 'Schippers', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Institute for Addiction Research, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Goudriaan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Institute for Addiction Research, Amsterdam, the Netherlands.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.002']
1028,31495506,Early pyeloplasty versus conservative management of severe ureteropelvic junction obstruction in asymptomatic infants.,"BACKGROUND


Ureteric-pelvic junction obstruction (UPJO) is the most common cause of antenatal and neonatal hydronephrosis and its management remains controversial. While conservative management is advocated for all, this strategy puts a quarter of these patients at risk for possibly irreversible renal damage.
AIM


In this study, we compare functional and anatomic outcomes in newborns and infants less than 1 year of age with high-grade unilateral UPJO, following early surgical pyeloplasty (ESP) versus conservative management (CM).
MATERIALS AND METHODS


This was a single center prospective interventional study. Infants referred to our tertiary care pediatric surgery clinic between September 2016 and September 2018 with UPJO were considered. To be included patients must have been less than 1 year old, lack of clinical symptoms, suffer from severe hydronephrosis as defined by Society for Fetal Urology (SFU) grades 3 or 4, and have affected kidney Split Renal Function (SRF) above 40%. Patients with bilateral disease, structural anomalies, or an abnormal voiding cystourethrogram (VCUG) were excluded. Anatomical and functional outcomes were measured and compared at 6 and 12 months.
RESULTS


Fifty-six patients were assigned to receive either ESP (n = 28) or CM (n = 28). At 6 months Cortical thickness, polar length, and SFU indices were significantly lower in the ESP group, while none of the outcomes were significantly different between the two groups at 12 months. Despite the two groups not being different at 12 months regarding differential renal function (DRF), there was a significant decrease of function in the CM group compared to baseline.
CONCLUSION


When considering treatment options for infants with high-grade UPJO, it appears that ESP hastens improvement of anatomic and functional indices, while CM may lead to a significant deterioration in renal function.",2020,"At 6 months Cortical thickness, polar length, and SFU indices were significantly lower in the ESP group, while none of the outcomes were significantly different between the two groups at 12 months.","['Infants referred to our tertiary care pediatric surgery clinic between September 2016 and September 2018 with UPJO were considered', 'patients must have been less than 1 year old, lack of clinical symptoms, suffer from severe hydronephrosis as defined by Society for Fetal Urology (SFU) grades 3 or 4, and have affected kidney Split Renal Function (SRF) above 40', 'asymptomatic infants', 'Patients with bilateral disease, structural anomalies, or an abnormal voiding cystourethrogram (VCUG) were excluded', 'Fifty-six patients', 'newborns and infants less than 1 year of age with high-grade unilateral UPJO, following early surgical pyeloplasty (ESP) versus conservative management (CM', 'infants with high-grade UPJO']","['Early pyeloplasty versus conservative management', 'ESP']","['functional and anatomic outcomes', 'Cortical thickness, polar length, and SFU indices', 'function', 'Anatomical and functional outcomes', 'differential renal function (DRF']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C3839137', 'cui_str': 'Pediatric surgery clinic (environment)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1629849', 'cui_str': 'Fluoroscopic cystourethrography'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0554139', 'cui_str': 'Reconstruction of ureteropelvic junction (procedure)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0554139', 'cui_str': 'Reconstruction of ureteropelvic junction (procedure)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0015373', 'cui_str': 'Extrasensory Perception'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0430198', 'cui_str': 'Differential renal function (procedure)'}]",56.0,0.0741235,"At 6 months Cortical thickness, polar length, and SFU indices were significantly lower in the ESP group, while none of the outcomes were significantly different between the two groups at 12 months.","[{'ForeName': 'Ahmad Khaleghnejad', 'Initials': 'AK', 'LastName': 'Tabari', 'Affiliation': ""Pediatric Surgery Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Atqiaee', 'Affiliation': ""Pediatric Surgery Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: khashayaratqiaee@gmail.com.""}, {'ForeName': 'Leily', 'Initials': 'L', 'LastName': 'Mohajerzadeh', 'Affiliation': ""Pediatric Surgery Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rouzrokh', 'Affiliation': ""Pediatric Surgery Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Ghoroubi', 'Affiliation': ""Pediatric Surgery Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': ""Department of Pediatric Urology Miami Children's Hospital Miami, FL.""}, {'ForeName': 'Saran', 'Initials': 'S', 'LastName': 'Lotfollahzadeh', 'Affiliation': ""Pediatric Surgery Research Center, Research Institute for Children's Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tabatabaey', 'Affiliation': 'Department of Emergency Medicine, Amiralmomenin Hospital, Islamic Azad University Tehran Medical Branch.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Bakaeean', 'Affiliation': 'Department of Biology, Science and Research Branch, Islamic Azad University, Tehran, Iran.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.08.006']
1029,31774485,Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers.,"Importance


Brief cognitive behavioral therapy (BCBT) is a clinically effective intervention for reducing risk of suicide attempts among suicidal US Army soldiers. However, because specialized treatments can be resource intensive, more information is needed on costs and benefits of BCBT compared with existing treatments.
Objective


To evaluate the cost-effectiveness of BCBT compared with treatment as usual for suicidal soldiers in the US Army.
Design, Setting, and Participants


A decision analytic model compared effects and costs of BCBT vs treatment as usual from a US Department of Defense (DoD) perspective. Model input data were drawn from epidemiologic data sets and a clinical trial among suicidal soldiers conducted from January 31, 2011, to April 3, 2014. Data were analyzed from July 3, 2018, to March 25, 2019.
Interventions


The strategies compared were treatment as usual alone vs treatment as usual plus 12 individual BCBT sessions. Treatment as usual could include a range of pharmacologic and psychological treatment options.
Main Outcomes and Measures


Costs in 2017 US dollars, suicide attempts averted (self-directed behavior with intent to die, but with nonfatal outcome), suicide deaths averted, and incremental cost-effectiveness ratios, assuming a 2-year time horizon for treatment differences but including lifetime costs.
Results


In the base-case analysis, BCBT was expected to avert approximately 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients treated than treatment as usual. Sensitivity analyses assuming a range of treatment effects showed BCBT to be cost saving in most scenarios. Using the federal discount rate, the DoD was estimated to save from $15 000 to $16 630 per patient with BCBT vs treatment as usual. In a worst-case scenario (ie, assuming the weakest plausible BCBT effect sizes), BCBT cost an additional $1910 to $2250 per patient compared with treatment as usual.
Conclusions and Relevance


Results suggest BCBT may be a cost-saving intervention for suicidal active-duty soldiers. The costs of ensuring treatment fidelity would also need to be considered when assessing the implications of disseminating BCBT across the entire DoD.",2020,"Using the federal discount rate, the DoD was estimated to save from $15 000 to $16 630 per patient with BCBT vs treatment as usual.",[],"['cognitive behavioral therapy (BCBT', 'BCBT', 'Brief Cognitive Behavioral Therapy']","['lifetime costs', 'suicide deaths', 'BCBT cost', ' suicide attempts averted (self-directed behavior with intent to die, but with nonfatal outcome), suicide deaths averted, and incremental cost-effectiveness ratios']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0516579,"Using the federal discount rate, the DoD was estimated to save from $15 000 to $16 630 per patient with BCBT vs treatment as usual.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Bernecker', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Zuromski', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Curry', 'Affiliation': 'Psychological Health Center of Excellence, Research and Development Directorate (J-9), Defense Health Agency, Silver Spring, Maryland.'}, {'ForeName': 'Jane J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Gutierrez', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Joiner', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee.'}, {'ForeName': 'Ronald C', 'Initials': 'RC', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Nock', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, University of Utah, Salt Lake City.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, University of Utah, Salt Lake City.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3639']
1030,31830211,Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials.,"Importance


For men with metastatic castration-resistant prostate cancer (mCRPC) whose condition is responding to enzalutamide, new unconfirmed bone lesions detected at posttreatment scinitigraphy may reflect an osteoblastic reaction that represents healing, known as pseudoprogression, which can lead to premature discontinuation of therapy.
Objective


To determine the association between new unconfirmed lesions detected on a follow-up bone scintigram (bone scan) and outcomes in enzalutamide-treated men with mCRPC.
Design, Setting, and Participants


This post hoc, retrospective secondary analysis of 1672 enzalutamide-treated men from 2 phase 3, randomized mCRPC studies (PREVAIL and AFFIRM) before or after treatment with docetaxel was conducted from April 12, 2018, to July 25, 2019. Participants were men from the enzalutamide groups of the 2 studies with a decrease in prostate-specific antigen level at any time or with stable disease or soft-tissue disease responding to treatment based onradiologic findings.
Intervention


Enzalutamide, 160 mg once daily.
Main Outcomes and Measures


The clinical significance of new lesions detected on the first (early) or second (late) posttreatment bone scan, without an unfavorable change in prostate-specific antigen level or soft-tissue progression, was investigated. Associations of new unconfirmed lesions with radiographic progression-free survival, overall survival, decrease in prostate-specific antigen level, objective response in soft tissue, and quality of life were evaluated.
Results


Among the 643 men (median age, 72 years [range, 43-93 years]) in PREVAIL, early and late unconfirmed lesions were observed in 177 men (27.5%) with stable disease or disease responding to enzalutamide. Among the 404 men (median age, 70 years [range, 41-88 years]) in AFFIRM, early and late unconfirmed lesions were observed in 73 men (18.1%) with stable disease or disease responding to enzalutamide. In PREVAIL, men with new unconfirmed lesions had median radiographic progression-free survival (hazard ratio [HR], 1.37 [95% CI, 0.81-2.30]; P = .23) and median overall survival (HR, 1.25 [95% CI, 0.85-1.83]) in the chemotherapy-naive setting similar to men those of men without such new lesions. In AFFIRM, the median overall survival (HR, 1.94 [95% CI, 1.10-3.44]) was reduced among men with unconfirmed bone lesions, but the median radiographic progression-free survival was not reduced (HR, 1.21 [95% CI, 0.83-1.75]; P = .32). Quality of life over time was similar regardless of the presence of new unconfirmed lesions detected on a follow-up bone scan in either setting.
Conclusions and Relevance


These results suggest that new unconfirmed lesions detected on follow-up bone scans may represent pseudoprogression in men with mCRPC and are indicative of a favorable treatment response to enzalutamide. The detection of new unconfirmed bone lesions in men with mCRPC that responded to treatment with enzalutamide after docetaxel appears to be associated with worse overall survival and may represent true progression, thus highlighting the need for improved functional bone metastasis imaging.
Trial Registration


ClinicalTrials.gov Identifiers: NCT01212991 and NCT00974311.",2020,"In AFFIRM, the median overall survival (HR, 1.94 [95% CI, 1.10-3.44]) was reduced among men with unconfirmed bone lesions, but the median radiographic progression-free survival was not reduced (HR, 1.21 [95% CI, 0.83-1.75]; P = .32).","['treated men with mCRPC.\nDesign, Setting, and Participants', 'Men', 'Participants were men from the enzalutamide groups of the 2 studies with a decrease in prostate-specific antigen level at any time or with stable disease or soft-tissue disease responding to treatment based onradiologic findings', 'men with mCRPC', 'men with metastatic castration-resistant prostate cancer (mCRPC', '1672 enzalutamide-treated men from 2 phase 3, randomized mCRPC studies (PREVAIL and AFFIRM) before or after treatment with', '643 men (median age, 72 years [range, 43-93 years]) in PREVAIL, early and late unconfirmed lesions were observed in 177 men (27.5%) with stable disease or disease responding to enzalutamide', '404 men (median age, 70 years [range, 41-88 years]) in AFFIRM, early and late unconfirmed lesions were observed in 73 men (18.1%) with stable disease or disease responding to enzalutamide']","['Enzalutamide', 'enzalutamide after docetaxel', 'enzalutamide', 'docetaxel', 'Enzalutamide, 160 mg once daily']","['median overall survival', 'median radiographic progression-free survival', 'radiographic progression-free survival, overall survival, decrease in prostate-specific antigen level, objective response in soft tissue, and quality of life', 'Quality of life', 'overall survival']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C4517674', 'cui_str': '27.5'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0034380'}]",,0.0974355,"In AFFIRM, the median overall survival (HR, 1.94 [95% CI, 1.10-3.44]) was reduced among men with unconfirmed bone lesions, but the median radiographic progression-free survival was not reduced (HR, 1.21 [95% CI, 0.83-1.75]; P = .32).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Division of Medical Oncology and Urology, Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, North Carolina.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Adhami', 'Affiliation': 'Biostatistics, Pfizer Inc, Cambridge, Massachusetts.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, Pfizer Inc, San Francisco, California.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Parli', 'Affiliation': 'Clinical Development, Pfizer Inc, San Francisco, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Biostatistics, Astellas Pharma Inc, Northbrook, Illinois.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Clinical Development, Astellas Pharma Inc, Northbrook, Illinois.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Division of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Medical Oncology, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'Division of Clinical Studies, The Institute of Cancer Research, The Royal Marsden National Health Service Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Division of Hematology/Medical Oncology, OHSU Knight Cancer Institute, Oregon Health & Science University, Portland.'}]",JAMA oncology,['10.1001/jamaoncol.2019.4636']
1031,31126887,Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial.,"OBJECTIVES


This study sought to assess the efficacy and safety of a drug-coated balloon (DCB) strategy versus drug-eluting stent (DES) in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI).
BACKGROUND


In primary percutaneous coronary intervention for STEMI, stenting has proved to be beneficial with regard to repeat revascularization, but not recurrent myocardial infarction or death, compared with balloon angioplasty alone. A strategy of DCB angioplasty without stenting might abolish the potential disadvantages of stent implantation while reducing the probability of restenosis observed in plain old balloon angioplasty.
METHODS


In the prospective, randomized, single-center REVELATION trial, we compared DCB with DES in patients presenting with STEMI. Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of <50% after pre-dilatation were randomized to treatment with a DCB or DES. The primary endpoint was fractional flow reserve at 9 months, allowing for a functional measurement of the infarct-related lesion.
RESULTS


A total of 120 patients were included. At 9 months after enrolment, the mean fractional flow reserve value was 0.92 ± 0.05 in the DCB group (n = 35) and 0.91 ± 0.06 in the DES group (n = 38) (p = 0.27). One abrupt vessel closure requiring treatment occurred after treatment with DCB. Up to 9-months follow-up, 2 patients required nonurgent target lesion revascularization (1 in each group).
CONCLUSIONS


In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months. Furthermore, it seemed to be a safe and feasible strategy. (Revascularization With Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stenting in Acute Myocardial Infarction [REVELATION]; NCT02219802).",2019,"In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months.","['patients presenting with STEMI', 'Myocardial Infarction', 'A total of 120 patients were included', 'Patients with a new, nonseverely calcified culprit lesion in a native coronary artery and a residual stenosis of\xa0<50% after pre-dilatation', 'Acute', 'Acute Myocardial Infarction [REVELATION']","['DCB or DES', 'DCB', 'Paclitaxel-Coated Balloon Angioplasty', 'Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent', 'Drug-Eluting Stenting', 'DCB angioplasty without stenting', 'drug-coated balloon (DCB) strategy versus drug-eluting stent (DES']","['nonurgent target lesion revascularization', 'mean fractional flow reserve value', 'fractional flow reserve at 9\xa0months, allowing for a functional measurement of the infarct-related lesion', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0904456,"In the setting of STEMI, the DCB strategy was noninferior to DES in terms of fractional flow reserve assessed at 9 months.","[{'ForeName': 'Nicola S', 'Initials': 'NS', 'LastName': 'Vos', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Nick D', 'Initials': 'ND', 'LastName': 'Fagel', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Amoroso', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Jean-Paul R', 'Initials': 'JR', 'LastName': 'Herrman', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Patterson', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Lieuwe H', 'Initials': 'LH', 'LastName': 'Piers', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis Hospital, Amsterdam, the Netherlands. Electronic address: m.a.vink@olvg.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.016']
1032,30664725,VCAP-AMP-VECP as a preferable induction chemotherapy in transplant-eligible patients with aggressive adult T-cell leukemia-lymphoma: a propensity score analysis.,"A dose-intensified multi-agent chemotherapy regimen called VCAP-AMP-VECP was investigated in Japan as front-line therapy for patients with adult T-cell leukemia-lymphoma (ATL). Although a prospective randomized controlled study showed that VCAP-AMP-VECP was superior to CHOP, the trial was rather small and no subsequent studies confirmed the benefit of VCAP-AMP-VECP over CHOP. We conducted a retrospective analysis of transplant-eligible patients with ATL who received only VCAP-AMP-VECP or CHOP, incorporating inverse probability of treatment weighting (IPTW) using propensity scoring. Overall, 947 and 513 patients were treated with VCAP-AMP-VECP and CHOP, respectively. The median follow-up of surviving patients was 1006 days. The crude probabilities of 2-year overall survival (OS) for patients in the VCAP-AMP-VECP and CHOP groups were 31.2% and 24.6%, respectively (P < 0.001). Stratified by risk group according to the modified ATL-prognostic index score at diagnosis, the crude probabilities of 2-year OS in the VCAP-AMP-VECP and CHOP groups were 39.8 and 45.0% in the low-risk group (P = 0.69), 32.2 and 21.6% in the intermediate-risk group (P < 0.001), and 17.2 and 6.2% in the high-risk group (P = 0.005). Our current analysis suggests that VCAP-AMP-VECP regimen is a preferable front-line therapy in patients with aggressive ATL in intermediate- and high-risk groups.",2019,"The crude probabilities of 2-year overall survival (OS) for patients in the VCAP-AMP-VECP and CHOP groups were 31.2% and 24.6%, respectively (P < 0.001).","['transplant-eligible patients with aggressive adult T-cell leukemia-lymphoma', 'transplant-eligible patients with ATL who received only', 'patients with aggressive ATL in intermediate- and high-risk groups', 'patients with adult T-cell leukemia-lymphoma (ATL']","['VCAP-AMP-VECP', 'VCAP-AMP-VECP or CHOP, incorporating inverse probability of treatment weighting (IPTW']",['crude probabilities of 2-year overall survival (OS'],"[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023493', 'cui_str': 'ATLL'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0327527,"The crude probabilities of 2-year overall survival (OS) for patients in the VCAP-AMP-VECP and CHOP groups were 31.2% and 24.6%, respectively (P < 0.001).","[{'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Fuji', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan. fujishige1231@gmail.com.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Atae', 'Initials': 'A', 'LastName': 'Utsunomiya', 'Affiliation': 'Department of Hematology, Imamura General Hospital, Kagoshima, Japan.'}, {'ForeName': 'Yukiyoshi', 'Initials': 'Y', 'LastName': 'Moriuchi', 'Affiliation': 'Department of Hematology, Sasebo City General Hospital, Sasebo, Japan.'}, {'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Owatari', 'Affiliation': 'Department of Hematology, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Hematology, Heart-Life Hospital, Okinawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sawayama', 'Affiliation': 'Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Otsuka', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital, Oita, Japan.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.'}]",Bone marrow transplantation,['10.1038/s41409-019-0446-z']
1033,31888670,Translational value of IDH1 and DNA methylation biomarkers in diagnosing lung cancers: a novel diagnostic panel of stage and histology-specificity.,"BACKGROUND


Lung cancer is the leading cause of cancer-related death worldwide, and the timely and serial assessment of low-dose computed tomography (LDCT) in high-risk populations remains a challenge. Furthermore, testing a single biomarker for the diagnosis of lung cancers is of relatively low effectiveness. Thus, a stronger diagnostic combination of blood biomarkers is needed to improve the diagnosis of non-small cell lung cancer (NSCLC).
METHODS


The blood levels of individual biomarkers [IDH1, DNA methylation of short stature homeobox 2 gene (SHOX2), and prostaglandin E receptor 4 gene (PTGER4)] were measured and statistically analyzed in samples from healthy controls and patients with lung cancer. In total, 221 candidates were enrolled and randomly assigned into two groups for the training and validation of a diagnostic panel. Additionally, a subgroup analysis was performed in the whole cohort.
RESULTS


A newly combined 3-marker diagnostic model for lung cancers was established and validated with area under the receiver operating characteristic (ROC) curve (AUC) values ranging from 0.835 to 0.905 in independent groups showing significantly stronger diagnostic value compared with a single tested biomarker. The sensitivity of the diagnostic model was as high as 86.1% and 80.0% in the training and validation sets, respectively. Although no apparent differences were found between the 3-marker and 2-marker models, the high clinical T-stage and histological type specificity of IDH1 and two other methylated DNA biomarkers were demonstrated in the subgroup analysis.
CONCLUSIONS


The combination of single biomarkers with high stage-specificity and histological type specificity (SHOX2 and PTGER4 DNA methylation and IDH1) showed better diagnostic performance in the detection of lung cancers compared with single marker assessment. A greater clinical utility of the panel may be developed by adding demographic/epidemiologic characteristics.",2019,"The sensitivity of the diagnostic model was as high as 86.1% and 80.0% in the training and validation sets, respectively.","['221 candidates', 'diagnosing lung cancers', 'healthy controls and patients with lung cancer']",[],"['receiver operating characteristic (ROC) curve (AUC) values', 'blood levels of individual biomarkers [IDH1, DNA methylation of short stature homeobox 2 gene (SHOX2), and prostaglandin E receptor 4 gene (PTGER4', 'sensitivity of the diagnostic model']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0013336', 'cui_str': 'Nanism'}, {'cui': 'C0242303', 'cui_str': 'Homeobox Sequence'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C2936367', 'cui_str': 'Prostaglandin EP4 Receptors'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",221.0,0.0726371,"The sensitivity of the diagnostic model was as high as 86.1% and 80.0% in the training and validation sets, respectively.","[{'ForeName': 'Ruochuan', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Runsen', 'Initials': 'R', 'LastName': 'Jin', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Jianbing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Chengming', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Sufei', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. sunnan@vip.126.com.'}, {'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. gaoshugeng@vip.sina.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. prof.jiehe@gmail.com.'}]",Journal of translational medicine,['10.1186/s12967-019-2117-7']
1034,31422087,"Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT.","OBJECTIVES


The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES).
BACKGROUND


The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
METHODS


A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.
RESULTS


Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (p log rank  = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, p log rank  = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES.
CONCLUSIONS


Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.",2019,"Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
","['patients with 3 contemporary drug-eluting stents (DES', 'A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention']","['durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES', 'SES', 'Ultrathin Strut Biodegradable- or Durable-Polymer-Coated Drug-Eluting Stents', 'ZES', '2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent']","['composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization', 'repeat revascularization', 'Definite or probable stent thrombosis rates', 'Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization', 'Target vessel failure', 'favorable 3-year safety and efficacy', '3-year safety and efficacy', 'individual components of target vessel failure and stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",3514.0,0.0438463,"Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.
","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'K Gert', 'Initials': 'KG', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'R Melvyn', 'Initials': 'RM', 'LastName': 'Tjon Joe Gin', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Somi', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.04.054']
1035,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance


Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data.
Objective


To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer.
Design, Setting, and Participants


The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.
Interventions


Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241).
Main Outcomes and Measures


The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy.
Results


Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]).
Conclusions and Relevance


Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207']
1036,32494991,Impact of a pharmacist-administered deprescribing intervention on nursing home residents: a randomized controlled trial.,"Background Polypharmacy is prevalent among long-term care residents in Canada, with 48.4% receiving ten or more different medications and 40.7% chronically prescribed potentially inappropriate medications. Objective We implemented a pharmacist-administered deprescribing program in a long-term care facility to determine if the number of medications taken per resident could be reduced.
SETTING


A long-term care facility in Newfoundland and Labrador, Canada from February 2017 to February 2018.
METHOD


Residents were randomized to receive either a deprescribing-focused medication review by a pharmacist or usual care. Main outcome measure Change in the number of medications at 3 and 6 months. Results Forty-five residents enrolled in the study (n = 22 intervention, n = 23 control). Seventy-eight deprescribing recommendations were made, and 85.1% were successfully implemented. The average number of medications taken by residents in the intervention group was 2.68 less than the control group (p < 0.02; 95% CI - 4.284, - 1.071) at 3 months and 2.88 less (p = 0.02, 95% CI - 4.543, - 1.112) at 6 months. In 14.9% of cases, a medication had to be restarted after deprescribing was attempted because symptoms returned.
CONCLUSION


A pharmacist-led deprescribing intervention can reduce the number of unnecessary and potentially harmful medications taken by LTC residents.",2020,"The average number of medications taken by residents in the intervention group was 2.68 less than the control group (p < 0.02; 95% CI - 4.284, - 1.071) at 3 months and 2.88 less (p = 0.02, 95% CI - 4.543, - 1.112) at 6 months.","['Results Forty-five residents enrolled in the study (n\u2009=\u200922 intervention, n\u2009=\u200923 control', 'nursing home residents', 'Residents', 'A long-term care facility in Newfoundland and Labrador, Canada from February 2017 to February 2018']","['deprescribing-focused medication review by a pharmacist or usual care', 'pharmacist-administered deprescribing program', 'pharmacist-administered deprescribing intervention']","['number of medications at 3 and 6\xa0months', 'average number of medications taken']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1956182', 'cui_str': 'Newfoundland and Labrador'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}]",45.0,0.102374,"The average number of medications taken by residents in the intervention group was 2.68 less than the control group (p < 0.02; 95% CI - 4.284, - 1.071) at 3 months and 2.88 less (p = 0.02, 95% CI - 4.543, - 1.112) at 6 months.","[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Balsom', 'Affiliation': ""Medication Therapy Services Clinic, School of Pharmacy, Memorial University, St. John's, NF, Canada. catherineb@mun.ca.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pittman', 'Affiliation': ""Medication Therapy Services Clinic, School of Pharmacy, Memorial University, St. John's, NF, Canada.""}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'King', 'Affiliation': ""St. Patrick's Mercy Home, St. John's, NF, Canada.""}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': ""Medication Therapy Services Clinic, School of Pharmacy, Memorial University, St. John's, NF, Canada.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01073-6']
1037,31473111,"Cefepime vs. meropenem for moderate-to-severe pneumonia in patients at risk for aspiration: An open-label, randomized study.","BACKGROUND


Treatment of aspiration pneumonia is an important problem due to aging of populations worldwide. However, the effectiveness of cefepime in aspiration pneumonia has not yet been evaluated.
AIM


To compare the clinical efficacy and safety of cefepime and meropenem in patients with moderate-to-severe aspiration pneumonia.
METHODS


In this open-label, randomized study, either cefepime 1 g or meropenem 0.5 g was administered intravenously every 8 h to patients with moderate-to-severe community-acquired or nursing-home acquired pneumonia at risk for aspiration for an average of 10.5 days. The primary outcome was the clinical response rate at the end of treatment (EOT) in the validated per-protocol (VPP)-population. Secondary outcomes were clinical response during treatment (days 4 and 7) and at the end of study (EOS) in the VPP-population, and survival at day 30 in the modified intention-to-treat (MITT)-population.
RESULTS


There was no difference between the groups in the primary or secondary outcomes or safety. Significant improvement was observed in each group on day 4.
CONCLUSION


Cefepime is as effective and safe as meropenem in the treatment of moderate-to-severe aspiration pneumonia.
CLINICAL TRIALS IDENTIFIER


UMIN000001349.",2020,"Cefepime is as effective and safe as meropenem in the treatment of moderate-to-severe aspiration pneumonia.
","['patients with moderate-to-severe aspiration pneumonia', 'patients at risk for aspiration', 'patients with moderate-to-severe community-acquired or nursing-home']","['cefepime 1\xa0g or meropenem', 'meropenem', 'cefepime and meropenem', 'Cefepime vs. meropenem']","['clinical response during treatment (days 4 and 7) and at the end of study (EOS) in the VPP-population, and survival', 'clinical response rate at the end of treatment (EOT', 'safety', 'clinical efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0150012', 'cui_str': 'At risk for aspiration'}, {'cui': 'C0456394', 'cui_str': 'Community acquired (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0055003', 'cui_str': 'cefepime'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}]",,0.0575398,"Cefepime is as effective and safe as meropenem in the treatment of moderate-to-severe aspiration pneumonia.
","[{'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Oi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Ito', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan; Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo 675-1332, Japan. Electronic address: isaoito@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan; Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo 675-1332, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Konishi', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan; Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo 675-1332, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Hamao', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Yasutomo', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo 675-1332, Japan.'}, {'ForeName': 'Seizo', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Internal Medicine, Ono Municipal Hospital, 323 Naka-cho, Ono, Hyogo 675-1332, Japan.'}, {'ForeName': 'Toyohiro', 'Initials': 'T', 'LastName': 'Hirai', 'Affiliation': 'Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Shogoin-kawaharacho, Sakyo, Kyoto 606-8507, Japan.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2019.08.005']
1038,31578918,Caffeine improves text reading and global perception.,"BACKGROUND


Reading is a unique human skill. Several brain networks involved in this complex skill mainly involve the left hemisphere language areas. Nevertheless, nonlinguistic networks found in the right hemisphere also seem to be involved in sentence and text reading. These areas do not deal with phonological information, but are involved in verbal and nonverbal pattern information processing. The right hemisphere is responsible for global processing of a scene, which is needed for developing reading skills.
AIMS


Caffeine seems to affect global pattern processing specifically. Consequently, our aim was to discover if it could enhance text reading skill.
METHODS


In two mechanistic studies ( n =24 and  n =53), we tested several reading skills, global and local perception, alerting, spatial attention and executive functions, as well as rapid automatised naming and phonological memory, using a double-blind, within-subjects, repeated-measures design in typical young adult readers.
RESULTS


A single dose of 200 mg caffeine improved global processing, without any effect on local information processing, alerting, spatial attention and executive or phonological functions. This improvement in global processing was accompanied by faster text reading speed of meaningful sentences, whereas single word/pseudoword or pseudoword text reading abilities were not affected. These effects of caffeine on reading ability were enhanced by mild sleep deprivation.
CONCLUSIONS


These findings show that a small quantity of caffeine could improve global processing and text reading skills in adults.",2020,"A single dose of 200 mg caffeine improved global processing, without any effect on local information processing, alerting, spatial attention and executive or phonological functions.","['adults', 'typical young adult readers']","['Caffeine', 'caffeine']","['text reading and global perception', 'several reading skills, global and local perception, alerting, spatial attention and executive functions', 'global processing', 'reading ability', 'local information processing, alerting, spatial attention and executive or phonological functions', 'global processing and text reading skills', 'single word/pseudoword or pseudoword text reading abilities']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]",,0.0838441,"A single dose of 200 mg caffeine improved global processing, without any effect on local information processing, alerting, spatial attention and executive or phonological functions.","[{'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Franceschini', 'Affiliation': 'Developmental and Cognitive Neuroscience Lab, Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lulli', 'Affiliation': ""Department of Experimental and Clinical Biomedical Sciences 'Mario Serio', University of Florence, Florence, Italy.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bertoni', 'Affiliation': 'Developmental and Cognitive Neuroscience Lab, Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gori', 'Affiliation': 'Department of Human and Social Sciences, University of Bergamo, Bergamo, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Angrilli', 'Affiliation': 'Developmental and Cognitive Neuroscience Lab, Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancarella', 'Affiliation': 'Developmental and Cognitive Neuroscience Lab, Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Puccio', 'Affiliation': 'Developmental and Cognitive Neuroscience Lab, Department of General Psychology, University of Padua, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Facoetti', 'Affiliation': 'Developmental and Cognitive Neuroscience Lab, Department of General Psychology, University of Padua, Padua, Italy.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119878178']
1039,31809418,Early Radiographic Union Score for Hip Is Predictive of Femoral Neck Fracture Complications Within 2 Years.,"OBJECTIVES


To determine if the Radiographic Union Score for Hip (RUSH) measured at 3 and 6 months after femoral neck fracture were predictive of reoperation for infection, nonunion, delayed union, avascular necrosis, or implant failure within 24 months of initial surgery.
DESIGN


Secondary analysis of a randomized controlled trial. Logistic regression was performed to investigate associations between lower RUSH and reoperation. Results were reported as odds ratios (OR), 95% confidence intervals (CIs), and associated P values. All tests were 2 tailed with alpha = 0.05.
SETTING


Eighty-one clinical sites across 8 countries.
PATIENTS/PARTICIPANTS


Data from 734 of the clinical trial participants with radiographs at 3 and 6 months after fracture fixation were included.
INTERVENTION


A reviewer blinded to patients' outcomes independently assigned a RUSH at each follow-up time point.
MAIN OUTCOME MEASURES


Revision surgery rate related to intervention.
RESULTS


Lower RUSH at 3 and 6 months were associated with increased odds of reoperation within 24 months of fracture fixation. For every 2-point decrease in RUSH at 3 months, there was a 16% increase in the odds of a patient experiencing a re-operation (OR, 1.16; 95% CI, 1.10-1.22; P < 0.0001). A similar association was observed at the 6-month assessment for every 2-point decrease (OR = 1.05; 95% CI, 1.01-1.09; P = 0.005).
CONCLUSIONS


Decreased radiographic healing as early as 3 months post fracture fixation is associated with developing patient important femoral neck fracture reoperations. This relationship may guide early treatment decisions, suggesting that 3- and 6-month RUSH are a useful surrogate measure of reoperations within 24 months of fracture fixation.
LEVEL OF EVIDENCE


Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Lower RUSH at 3 and 6 months were associated with increased odds of reoperation within 24 months of fracture fixation.","['Eighty-one clinical sites across 8 countries', 'Data from 734 of the clinical trial participants with radiographs at 3 and 6 months after fracture fixation were included']",[],"['Radiographic Union Score for Hip (RUSH', 'odds of reoperation', 'Revision surgery rate related to intervention', 'RUSH', 'radiographic healing', 'reoperation for infection, nonunion, delayed union, avascular necrosis, or implant failure']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027543', 'cui_str': 'Avascular necrosis of bone'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}]",2.0,0.130555,"RESULTS


Lower RUSH at 3 and 6 months were associated with increased odds of reoperation within 24 months of fracture fixation.","[{'ForeName': 'Martí', 'Initials': 'M', 'LastName': 'Bernaus', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Universitari Mútua Terrassa, Barcelona, Spain.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Swiontkowski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001713']
1040,31451521,"Effect of Intermittent Versus Continuous Low-Dose Aspirin on Nasal Epithelium Gene Expression in Current Smokers: A Randomized, Double-Blinded Trial.","A chemopreventive effect of aspirin (ASA) on lung cancer risk is supported by epidemiologic and preclinical studies. We conducted a randomized, double-blinded study in current heavy smokers to compare modulating effects of intermittent versus continuous low-dose ASA on nasal epithelium gene expression and arachidonic acid (ARA) metabolism. Fifty-four participants were randomized to intermittent (ASA 81 mg daily for one week/placebo for one week) or continuous (ASA 81 mg daily) for 12 weeks. Low-dose ASA suppressed urinary prostaglandin E2 metabolite (PGEM; change of -4.55 ± 11.52 from baseline 15.44 ± 13.79 ng/mg creatinine for arms combined,  P  = 0.02), a surrogate of COX-mediated ARA metabolism, but had minimal effects on nasal gene expression of nasal or bronchial gene-expression signatures associated with smoking, lung cancer, and chronic obstructive pulmonary disease. Suppression of urinary PGEM correlated with favorable changes in a smoking-associated gene signature ( P  < 0.01). Gene set enrichment analysis (GSEA) showed that ASA intervention led to 1,079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database. In conclusion, low-dose ASA had minimal effects on known carcinogenesis gene signatures in nasal epithelium of current smokers but results in wide-ranging genomic changes in the nasal epithelium, demonstrating utility of nasal brushings as a surrogate to measure gene-expression responses to chemoprevention. PGEM may serve as a marker for smoking-associated gene-expression changes and systemic inflammation. Future studies should focus on NSAIDs or agent combinations with broader inhibition of pro-inflammatory ARA metabolism to shift gene signatures in an anti-carcinogenic direction.",2019,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"['Fifty-four participants were randomized to intermittent ', 'current heavy smokers', 'current smokers']","['intermittent versus continuous low dose ASA', 'aspirin (ASA', 'placebo', 'intermittent versus continuous low dose aspirin', 'ASA intervention', 'ASA']","['nasal epithelium gene expression', 'lung cancer risk', 'Suppression of urinary PGEM', 'urinary prostaglandin E2 metabolite (PGEM', 'nasal epithelium gene expression and arachidonic acid (ARA) metabolism']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0857118', 'cui_str': 'Heavy smoker'}, {'cui': 'C3241966'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0599331', 'cui_str': 'Nasal Epithelium'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",54.0,0.22044,Gene set enrichment analysis (GESA) showed that ASA intervention led to 1079 enriched gene sets from the Canonical Pathways within the Molecular Signatures Database.,"[{'ForeName': 'Linda L', 'Initials': 'LL', 'LastName': 'Garland', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona. lgarland@azcc.arizona.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Guillen-Rodriguez', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Chiu-Hsieh', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Szabo', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Merenstein', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Lel', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Hanqiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Avrum E', 'Initials': 'AE', 'LastName': 'Spira', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Beane', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wojtowicz', 'Affiliation': 'Division of Cancer Prevention, NCI/NIH, Boston, Massachusetts.'}, {'ForeName': 'H-H Sherry', 'Initials': 'HS', 'LastName': 'Chow', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0036']
1041,31195828,Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments: Reliability and Validity in Veterans Following Orthopedic Surgery.,"The patient-reported outcomes measurement information system (PROMIS) offers standardized assessment measures of clinically relevant patient-reported outcomes. This study evaluated the reliability and validity of select PROMIS measures with U.S. military veterans following orthopedic surgery. Data for the current study were collected as part of a pilot randomized control trial assessing the efficacy of a 1-day Acceptance and Commitment Therapy workshop on persistent postsurgical pain in at-risk veterans undergoing orthopedic surgery. Sixty-seven participants completed surveys 3 months after surgery. Participants completed the following PROMIS instruments: PROMIS Anxiety Short Form 8a, PROMIS Depression Short Form 8b, and PROMIS Pain Interference Short Form 8a. PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively. All three PROMIS measures demonstrated excellent internal consistency (Cronbach's αs ranged from .93 to .96) and each loaded onto a single factor. The PROMIS measures were moderately correlated with their respective comparison measures ( r  = .69 to .76). The PROMIS anxiety and PROMIS depression measures were highly correlated to one another ( r  = .91). Findings highlight the potential utility of these PROMIS measures in veterans following orthopedic surgery and the overlap between the PROMIS depression and anxiety measures in this sample.",2019,"PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively.","['Veterans Following Orthopedic Surgery', 'U.S. military veterans following orthopedic surgery', 'at-risk veterans undergoing orthopedic surgery']",['1-day Acceptance and Commitment Therapy workshop'],"['PROMIS anxiety and PROMIS depression measures', 'Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3874856', 'cui_str': 'Generalized anxiety disorder 7 item scale (assessment scale)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",67.0,0.0603727,"PROMIS measures were compared to the Generalized Anxiety Disorder 7-Item Scale, the Patient Health Questionnaire 9-Item Scale, and the Brief Pain Inventory Pain Interference subscale, respectively.","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Hadlandsmyth', 'Affiliation': '1 Department of Anesthesia, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Lilian N', 'Initials': 'LN', 'LastName': 'Dindo', 'Affiliation': '2 Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'St Marie', 'Affiliation': '3 College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Roohina', 'Initials': 'R', 'LastName': 'Wajid', 'Affiliation': '3 College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jennie L', 'Initials': 'JL', 'LastName': 'Embree', 'Affiliation': '3 College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Nicolas O', 'Initials': 'NO', 'LastName': 'Noiseux', 'Affiliation': '4 Orthopedics and Rehabilitation, Carver College of Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Tripp-Reimer', 'Affiliation': '3 College of Nursing, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': '5 College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': '3 College of Nursing, University of Iowa, Iowa City, IA, USA.'}]",Evaluation & the health professions,['10.1177/0163278719856406']
1042,32441198,"Effects of Vitamin D and Omega-3 Fatty Acids Co-Supplementation on Inflammatory Factors and Tumor Marker CEA in Colorectal Cancer Patients Undergoing Chemotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","Objectives:  This study aimed to investigate the effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory factors and tumor marker CEA in colorectal cancer patients undergoing chemotherapy. Methods:  In this study, 81 patients with stage ӀӀ or ӀӀӀ colorectal cancer were randomly assigned into four groups: (1) control: receiving a vitamin D placebo, weekly + two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids), daily + a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000 IU vitamin D soft gel, weekly + two omega-3 fatty acids capsules, for 8 weeks. Before and after the intervention, serum levels of 25(OH)D, TNF-α, IL-1β, IL-6, IL-8, NF-kB activity, and tumor marker CEA, were measured. Results:  After 8 weeks of intervention, patients who received combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo had significantly decreased TNF-α, and IL-1β ( P  < .05). In addition, serum levels of TNF-α, IL-1β, IL-6, IL-8, and tumor marker CEA were decreased significantly in omega-3, vitamin D, and co-supplementation of them, compared with baseline. NF-kB activity was decreased significantly in vitamin D and co-supplementation groups, compared with baseline. Regarding CEA, there was no significant difference between the four groups at the end of intervention ( P  > .05). Conclusion:  Results show that co-supplementation of vitamin D and omega-3 fatty acids co-supplementation, in colorectal cancer patients have beneficial impacts on inflammation and tumor marker CEA.",2020,"Regarding CEA, there was no significant difference between the four groups at the end of intervention ( P  > .05).","['colorectal cancer patients', 'colorectal cancer patients undergoing chemotherapy', 'Colorectal Cancer Patients', '81 patients with stage ӀӀ or ӀӀӀ colorectal cancer']","['Placebo', 'vitamin D placebo, weekly\u2009+\u2009two omega-3 fatty acid placebo capsules, daily; (2) omega-3 fatty acid, receiving two omega-3 fatty acid capsules (each capsule containing 330\u2009mg of omega-3 fatty acids), daily\u2009+\u2009a vitamin D placebo, weekly; (3) vitamin D, receiving a 50,000\u2009IU vitamin D soft gel, weekly\u2009+\u2009two omega-3 fatty acid placebo capsules, daily; (4) co-supplementation, receiving a 50,000\u2009IU vitamin D soft gel, weekly\u2009+\u2009two omega-3 fatty acids capsules', 'Undergoing Chemotherapy', 'combined vitamin D and omega-3 fatty acids supplements compared with omega-3, vitamin D, and placebo', 'Vitamin D and Omega-3 Fatty Acids Co-Supplementation', 'vitamin D and omega-3 fatty acids co-supplementation']","['serum levels of TNF-α, IL-1β, IL-6, IL-8, and tumor marker CEA', 'serum levels of 25(OH)D, TNF-α, IL-1β, IL-6, IL-8, NF-kB activity, and tumor marker CEA', 'inflammatory factors and tumor marker CEA', 'NF-kB activity', 'TNF-α, and IL-1β', 'Inflammatory Factors and Tumor Marker CEA']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0310589', 'cui_str': 'Vitamin A- and vitamin D-containing product'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",81.0,0.302644,"Regarding CEA, there was no significant difference between the four groups at the end of intervention ( P  > .05).","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Department of Medical Oncology and Hematology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Nutrition and cancer,['10.1080/01635581.2019.1659380']
1043,31451566,Falls and Cognitive Training 2 (FaCT2) study protocol: a randomised controlled trial exploring cognitive training to reduce risk of falls in at-risk older adults.,"BACKGROUND


The primary cause of traumatic injury in older adults is fall. Recent reports suggest that cognitive function contributes significantly to fall risk. Therefore, by targeting cognitive function for intervention, we could potentially reduce the incidence of fall and injury.
PRIMARY OBJECTIVE


To explore the effectiveness of a 16-week cognitive training (CT) intervention to reduce risk and incidence of fall in community-dwelling older adults at risk for fall.
OUTCOMES


Primary outcome is number of falls over a 16-week period (ascertained by fall calendar method). Secondary outcomes include: change fall risk as indicated by improvement in 10 m walk and 90 s balance tests.
DESIGN/METHODS


The design is a two-group randomised controlled trial. Eligible participants are older adults (aged 65-85) residing in the community who are at risk for fall based on physical performance testing. Following completion of 1-week run-in phase, participants are randomly allocated (1:2) to either a group that is assigned to attention control or to the group that receives CT intervention for a total of 16 weeks. Participants are followed for an additional 4 weeks after intervention. Mann-Whitney U test and Student's t-test will be used to examine between-group differences using intention-to-treat analyses.
DISCUSSION


Limited evidence supports the potential of CT to improve cognition and gait, but no published study has evaluated whether such an intervention would reduce incidence of fall. The present trial is designed to provide initial answers to this question. CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders.
TRIAL REGISTRATION NUMBER


NCT03190460.",2020,"CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders.
","['older adults', 'at-risk older adults', 'community-dwelling older adults at risk for fall', 'Eligible participants are older adults (aged 65-85) residing in the community who are at risk for fall based on physical performance testing']","['CT', 'cognitive training', 'attention control or to the group that receives CT intervention', 'cognitive training (CT) intervention']","['number of falls over a 16-week period (ascertained by fall calendar method', ' change fall risk as indicated by improvement in 10 m walk and 90\u2009s balance tests', 'risk of falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607857'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0797019,"CT may also improve functioning important in other activities (eg, driving), reducing overall risk of injury in elders.
","[{'ForeName': 'Hilaire J', 'Initials': 'HJ', 'LastName': 'Thompson', 'Affiliation': 'Biobehavioral Nursing and Health Informatics, University of Washington Seattle Campus, Seattle, Washington, USA hilairet@uw.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McGough', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington Seattle Campus, Seattle, Washington, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Demiris', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]",Injury prevention : journal of the International Society for Child and Adolescent Injury Prevention,['10.1136/injuryprev-2019-043332']
1044,31764959,Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials.,"Importance


Alzheimer disease (AD) is a neurodegenerative disorder characterized by cognitive deterioration and impaired activities of daily living. Current treatments provide only minor symptomatic improvements with limited benefit duration. Lanabecestat, a brain-permeable inhibitor of human beta-site amyloid precursor protein-cleaving enzyme 1 (BACE1/β-secretase), was developed to modify the clinical course of AD by slowing disease progression.
Objective


To assess whether lanabecestat slows the progression of AD compared with placebo in patients with early AD (mild cognitive impairment) and mild AD dementia.
Design, Setting, and Participants


AMARANTH (first patient visit on September 30, 2014; last patient visit on October 4, 2018) and DAYBREAK-ALZ (first patient visit on July 1, 2016; last patient visit on September 28, 2018) were randomized, placebo-controlled, phase 2/3 and phase 3 clinical trials lasting 104 weeks and 78 weeks, respectively. AMARANTH and DAYBREAK-ALZ were multicenter, global, double-blind studies conducted at 257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively. A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging-Alzheimer's Association criteria for early AD or mild AD dementia was screened using cognitive assessments, and the presence of amyloid was confirmed. Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation. AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study. DAYBREAK-ALZ screened 5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study.
Interventions


Patients were randomized (1:1:1) to once-daily oral doses of lanabecestat (20 mg), lanabecestat (50 mg), or placebo.
Main Outcomes and Measures


The primary outcome measure was change from baseline on the 13-item Alzheimer Disease Assessment Scale-cognitive subscale. Secondary outcomes included Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory. Efficacy analyses were conducted on the intent-to-treat population.
Results


Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women. Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women. Both studies were terminated early after futility analysis. There were no consistent, reproducible dose-related findings on primary or secondary efficacy measures. Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
Conclusions and Relevance


Treatment with lanabecestat was well tolerated and did not slow cognitive or functional decline.
Trial Registration


ClinicalTrials.gov identifiers: NCT02245737 and NCT02783573.",2020,"Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
","['Among 1722 DAYBREAK-ALZ patients, the mean (SD) age was 72.3 (7.0) years, and 1023 of 1722 (59.4%) were women', 'AMARANTH screened 6871 patients; 2218 (32.3%) were randomized, and 539 patients completed the study', 'Among 2218 AMARANTH patients, the mean (SD) age was 71.3 (7.1) years, and 1177 of 2218 (53.1%) were women', '5706 patients; 1722 (30.2%) were randomized, and 76 patients completed the study', '257 and 251 centers, respectively, located in 15 and 18 countries or territories, respectively', 'Patients were excluded for unstable medical conditions or medication use, significant cerebrovascular pathologic findings, or a history of vitiligo and/or current evidence of postinflammatory hypopigmentation', 'patients with early AD (mild cognitive impairment) and mild AD dementia', 'Early and Mild Alzheimer Disease', ""A population-based sample of men and women aged 55 to 85 years who met National Institute on Aging-Alzheimer's Association criteria for early AD or mild AD dementia""]","['placebo', 'lanabecestat (20 mg), lanabecestat (50 mg), or placebo', 'Lanabecestat', 'lanabecestat']","['13-item Alzheimer Disease Assessment Scale-cognitive subscale', 'Efficacy and Safety', ""Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory, Clinical Dementia Rating, Functional Activities Questionnaire, Mini-Mental State Examination, and Neuropsychiatric Inventory"", 'Psychiatric adverse events, weight loss, and hair color changes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002406', 'cui_str': 'Amaranth Dye'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0333612', 'cui_str': 'Postinflammatory hypopigmentation (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1955974', 'cui_str': 'National Institute on Aging'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0474378', 'cui_str': 'Hair color change (finding)'}]",539.0,0.552879,"Psychiatric adverse events, weight loss, and hair color changes were reported in a higher percentage of patients receiving lanabecestat than placebo.
","[{'ForeName': 'Alette M', 'Initials': 'AM', 'LastName': 'Wessels', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, University of Arizona College of Medicine, Phoenix.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Zimmer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Selzler', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sonja M', 'Initials': 'SM', 'LastName': 'Bragg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Andersen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Krull', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'AnnCatherine M', 'Initials': 'AM', 'LastName': 'Downing', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Willis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shcherbinin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Mullen', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barker', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schumi', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Shering', 'Affiliation': 'AstraZeneca, Waltham, Massachusetts, and Gaithersburg, Maryland.'}, {'ForeName': 'Brandy R', 'Initials': 'BR', 'LastName': 'Matthews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Stern', 'Affiliation': ""Alzheimer's Disease Center, Boston University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle, Centre Hospitalier Universitaire de Toulouse, Unités Mixtes de Recherche Institut National de la Santé et de la Recherche Médicale 1027, Université Toulouse III-Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Toronto Memory Program, Toronto, Ontario, Canada.'}, {'ForeName': 'Emer', 'Initials': 'E', 'LastName': 'MacSweeney', 'Affiliation': 'Re:Cognition Health, London, United Kingdom.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Boada', 'Affiliation': 'Research Center and Memory Clinic, Fundació Alzheimer Centre Educacional, Institut Català de Neurociències Aplicades, Barcelona-Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Sims', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3988']
1045,31995132,Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.,"Importance


Patients with residual depressive symptoms face a gap in care because few resources, to date, are available to manage the lingering effects of their illness.
Objective


To evaluate the effectiveness for treating residual depressive symptoms with Mindful Mood Balance (MMB), a web-based application that delivers mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only.
Design, Setting, and Participants


This randomized clinical trial was conducted in primary care and behavioral health clinics at Kaiser Permanente Colorado, Denver. Adults identified with residual depressive symptoms were recruited between March 2, 2015, and November 30, 2018. Outcomes were assessed for a 15-month period, comprising a 3-month intervention interval and a 12-month follow-up period.
Interventions


Patients were randomized to receive usual depression care (UDC; n = 230) or MMB plus UDC (n = 230), which included 8 sessions delivered online for a 3-month interval plus minimal phone or email coaching support.
Main Outcomes and Measures


Primary outcomes were reduction in residual depressive symptom severity, assessed using the Patient Health Questionaire-9 (PHQ-9); rates of depressive relapse (PHQ-9 scores ≥15); and rates of remission (PHQ-9 scores <5). Secondary outcomes included depression-free days, anxiety symptoms (General Anxiety Disorder-7 Item Scale), and functional status (12-Item Short Form Survey).
Results


Among 460 randomized participants (mean [SD] age, 48.30 [14.89] years; 346 women [75.6%]), data were analyzed for the intent-to-treat sample, which included 362 participants (78.7%) at 3 months and 330 (71.7%) at 15 months. Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P < .02). A significantly greater proportion of patients achieved remission in the MMB plus UDC group compared with the UDC only group (PHQ-9 score, <5: β [SE], 0.38 [0.14], P = .008), and rates of depressive relapse were significantly lower in the MMB plus UDC group compared with the UDC only group (hazard ratio, 0.61; 95% CI, 0.39-0.95; P < .03). Compared with the UDC only group, the MMB plus UDC group had decreased depression-free days (mean [SD], 281.14 [164.99] days vs 247.54 [158.32] days; difference, -33.60 [154.14] days; t = -2.33; P = .02), decreased anxiety (mean [SE] General Anxiety Disorder-7 Item Scale score, 1.21 [0.42], P = .004), and improved mental functioning (mean [SE] 12-Item Short Form Survey score, -5.10 [1.37], P < .001), but there was no statistically significant difference in physical functioning.
Conclusions and Relevance


Use of MMB plus UDC resulted in significant improvement in depression and functional outcomes compared with UDC only. The MMB web-based treatment may offer a scalable approach for the management of residual depressive symptoms.
Trial Registration


ClinicalTrials.gov identifier: NCT02190968.",2020,"Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P < .02).","['primary care and behavioral health clinics at Kaiser Permanente Colorado, Denver', 'Patients With Residual Depressive Symptoms', '460 randomized participants (mean [SD] age, 48.30', 'Adults identified with residual depressive symptoms were recruited between March 2, 2015, and November 30, 2018', '14.89] years; 346 women [75.6%]), data were analyzed for the intent-to-treat sample, which included 362 participants (78.7%) at 3 months and 330 (71.7%) at 15 months']","['UDC', 'Online Mindfulness-Based Cognitive Therapy', 'usual depression care (UDC; n\u2009=\u2009230) or MMB plus UDC (n\u2009=\u2009230), which included 8 sessions delivered online for a 3-month interval plus minimal phone or email coaching support', 'MMB plus UDC', 'mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only', 'Mindful Mood Balance (MMB']","['proportion of patients achieved remission', 'mental functioning', 'physical functioning', 'depression and functional outcomes', 'residual depressive symptoms', 'decreased anxiety (mean [SE] General Anxiety Disorder-7 Item Scale score', 'residual depressive symptom severity, assessed using the Patient Health Questionaire-9 (PHQ-9); rates of depressive relapse (PHQ-9 scores ≥15); and rates of remission (PHQ-9 scores <5', 'depression-free days, anxiety symptoms (General Anxiety Disorder-7 Item Scale), and functional status (12-Item Short Form Survey', 'rates of depressive relapse']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",460.0,0.147985,"Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P < .02).","[{'ForeName': 'Zindel V', 'Initials': 'ZV', 'LastName': 'Segal', 'Affiliation': 'Graduate Department Psychological Clinical Science, University of Toronto Scarborough, Toronto, Ontario, Canada.'}, {'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'University of Colorado Boulder, Boulder.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Beck', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Denver.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Boggs', 'Affiliation': 'Kaiser Permanente Colorado, Institute for Health Research, Denver.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Vanderkruik', 'Affiliation': 'University of Colorado Boulder, Boulder.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Metcalf', 'Affiliation': 'University of Colorado Boulder, Boulder.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Westchester University, Chester County, Pennsylvania.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Felder', 'Affiliation': 'University of California, San Francisco, San Francisco.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'University of Colorado Boulder, Boulder.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4693']
1046,32048203,Effects of intravenous and mask induction on post-operative emergence delirium in pediatric patients undergoing tonsillectomy with or without adenoidectomy.,"BACKGROUND


Emergence delirium occurs in children during recovery from general anesthesia. The aim of the study was to examine the effects of mask and intravenous sevoflurane anesthesia induction on emergence delirium in children undergoing tonsillectomy with or without adenoidectomy.
METHODS


This single-blinded, prospective, randomized clinical trial was conducted in the operating room and the post-operative recovery area at a university hospital. Sixty-seven children (aged 3-12 years) were randomly assigned to receive either mask induction (group M) or intravenous induction (group IV). Vascular access was provided in group M after 8% sevoflurane and 60% nitrous oxide in oxygen were given through a mask. In the IV cohort, an intravenous cannula was inserted prior to induction. The incidence of emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale after arrival in the post-anesthesia care unit. Post-operative pain was assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale.
RESULTS


PAED scores were significantly higher in group M at 5 min (group M = 12.2 ± 4.215, group IV = 9.1 ± 4.0; mean difference = 3.094, 95% CI [1.108; 5.081]; P = 0.003), at 15 min (group M = 8.0 ± 2.6, group IV = 5.1 ± 2.3; mean difference = 2.942, 95% CI [1.586-4.301]; P < 0.001), and at 30 min (group M = 5.1 ± 2.8, group IV = 2.5 ± 1.8; mean difference = 2.620, 95% CI [1.457; 3.783]; P < 0.001) than in group IV. The FLACC scale scores were similar between the two groups.
CONCLUSION


Mask induction for pediatric patients undergoing tonsillectomy with or without adenoidectomy increased Pediatric Anesthesia Emergence Delirium scores more than intravenous induction.
TRIAL REGISTRATION


NCT03252405.",2020,"RESULTS


PAED scores were significantly higher in group M at 5 min (group M = 12.2 ± 4.215, group IV = 9.1 ± 4.0; mean difference = 3.094, 95% CI [1.108; 5.081]; P = 0.003), at 15 min (group M = 8.0 ± 2.6, group IV = 5.1 ± 2.3; mean difference = 2.942, 95% CI [1.586-4.301]; P < 0.001), and at 30 min (group M = 5.1 ± 2.8, group IV = 2.5 ± 1.8; mean difference = 2.620, 95% CI [1.457; 3.783]; P < 0.001) than in group IV.","['children during recovery from general anesthesia', 'pediatric patients undergoing tonsillectomy with or without adenoidectomy', 'children undergoing tonsillectomy with or without adenoidectomy', 'pediatric patients undergoing', 'Sixty-seven children (aged 3-12\xa0years']","['sevoflurane anesthesia induction', 'intravenous and mask induction', 'tonsillectomy with or without adenoidectomy', 'sevoflurane and 60% nitrous oxide', 'mask induction (group M) or intravenous induction']","['Pediatric Anesthesia Emergence Delirium scores', 'PAED scores', 'Vascular access', 'Face, Legs, Activity, Cry, and Consolability (FLACC) scale', 'Pediatric Anesthesia Emergence Delirium (PAED) scale', 'FLACC scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0412768', 'cui_str': 'Inhalational induction (procedure)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0001425', 'cui_str': 'Adenoidectomy'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0920253', 'cui_str': 'Postanesthetic Excitement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0222045'}]",67.0,0.219269,"RESULTS


PAED scores were significantly higher in group M at 5 min (group M = 12.2 ± 4.215, group IV = 9.1 ± 4.0; mean difference = 3.094, 95% CI [1.108; 5.081]; P = 0.003), at 15 min (group M = 8.0 ± 2.6, group IV = 5.1 ± 2.3; mean difference = 2.942, 95% CI [1.586-4.301]; P < 0.001), and at 30 min (group M = 5.1 ± 2.8, group IV = 2.5 ± 1.8; mean difference = 2.620, 95% CI [1.457; 3.783]; P < 0.001) than in group IV.","[{'ForeName': 'Kevser', 'Initials': 'K', 'LastName': 'Peker', 'Affiliation': 'Department of Anesthesiology and Critical Care, Kırıkkale University School of Medicine, Kırıkkale, Turkey. drbabacan@hotmail.com.'}, {'ForeName': 'Reyhan', 'Initials': 'R', 'LastName': 'Polat', 'Affiliation': 'Department of Anesthesiology and Critical Care, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02197-4']
1047,31462735,MRD response in relapsed/refractory FL after obinutuzumab plus bendamustine or bendamustine alone in the GADOLIN trial.,"We report assessment of minimal residual disease (MRD) status and its association with outcome in rituximab-refractory follicular lymphoma (FL) in the randomized GADOLIN trial (NCT01059630). Patients received obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone. Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement) detected at study screening were assessed for MRD at mid-induction (MI), end of induction (EOI), and every 6-24 months post-EOI/discontinuation by real-time quantitative PCR. At MI, 41/52 (79%) patients receiving G-Benda were MRD-negative vs. 17/36 (47%) patients receiving Benda alone (p = 0.0029). At EOI, 54/63 (86%) patients receiving G-Benda were MRD-negative vs. 30/55 (55%) receiving Benda alone (p = 0.0002). MRD-negative patients at EOI had improved progression-free survival (HR, 0.33, 95% CI, 0.19-0.56, p < 0.0001) and overall survival (HR, 0.39, 95% CI, 0.19-0.78, p = 0.008) vs. MRD-positive patients, and maintained their MRD-negative status for longer if they received G maintenance than if they did not. These results suggest that the addition of G to Benda-based treatment during induction can significantly contribute to the speed and depth of response, and G maintenance in MRD-negative patients potentially delays lymphoma regrowth.",2020,patients receiving Benda alone (p = 0.0029).,"['rituximab-refractory follicular lymphoma (FL', 'Patients with a clonal marker (t[14;18] translocation and/or immunoglobulin heavy or light chain rearrangement']","['obinutuzumab (G) plus bendamustine (Benda) induction followed by G maintenance, or Benda induction alone', 'bendamustine']","['MRD response', 'progression-free survival', 'overall survival']","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0473059,patients receiving Benda alone (p = 0.0029).,"[{'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany. c.pott@med2.uni-kiel.de.'}, {'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'British Columbia Cancer Agency and the University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Department of Internal Medicine-Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gribben', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'Hospital of the Ludwig-Maximilians University, Munich, Germany.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Kehden', 'Affiliation': 'University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Nicolas-Virelizier', 'Affiliation': 'University of Lyon, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Harbron', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Mundt', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Wassner-Fritsch', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Cheson', 'Affiliation': 'Georgetown University Hospital, Washington, DC, USA.'}]",Leukemia,['10.1038/s41375-019-0559-9']
1048,32440738,Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial.,"Background Pulmonary hypertension is a rare, chronic and life-threatening group of diseases. Recent advances in pulmonary hypertension management prolong survival and improve quality-of-life. However, highly complex drug therapy enhances the risk of drug-related problems. Objective To assess the impact of involving clinical pharmacists in the collaborative care of pulmonary hypertension patients. Setting Ten French University Hospital Pneumology departments, all members of the French Network for Pulmonary Hypertension. Methods This prospective multicenter randomized controlled trial included incident pulmonary hypertension patients who were followed-up for 18 months. Randomization using an adapted Zelen method allocated patients to collaborative care (n = 41) or usual care groups (n = 51). A collaborative care program involving clinical pharmacists was developed through a close partnership between with physicians, nurses and pharmacists. Besides usual care, the program includes regular one-to-one interviews between the pharmacist and the patient. These interviews had following objectives: to perform an exhaustive medication history review; to identify the patient' needs, knowledge and skills; to define educational objectives and to provide patients with relevant information when needed. Following each interview, a standardized report form containing the pharmacist's recommendations was provided to physicians and nurses and discussed collaboratively. An ancillary economic analysis was performed. Main outcome measure Number of drug-related problems and their outcomes. Results The number of drug-related problems was not significantly different between groups (1.6 ± 1.5 vs. 1.9 ± 2.4; p = 0.41). More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01). Time to clinical worsening, therapeutic adherence, satisfaction or quality-of-life were not statistically different between groups. Collaborative care decreased costs of drug-related hospitalizations. Conclusion Including clinical pharmacists in the multidisciplinary care of hospitalized patients with pulmonary hypertension improved the outcome of drug-related problems and reduced the costs of related hospitalization. However, we observed no efficacy on medication errors, clinical outcomes or medication adherence. Clinical Trial Registration ClinicalTrials.gov Identifier NCT01038284.",2020,"More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01).","['incident pulmonary hypertension patients who were followed-up for 18\xa0months', 'pulmonary hypertension patients', 'Setting Ten French University Hospital Pneumology departments, all members of the French Network for Pulmonary Hypertension', 'hospitalized patients with pulmonary hypertension']","['adapted Zelen method allocated patients to collaborative care (n\u2009=\u200941) or usual care groups', 'collaborative care program']","['number of drug-related problems', 'medication errors, clinical outcomes or medication adherence', 'quality-of-life', 'Time to clinical worsening, therapeutic adherence, satisfaction or quality-of-life', 'Number of drug-related problems and their outcomes', 'costs of drug-related hospitalizations', 'costs of related hospitalization']","[{'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.128263,"More problems were resolved in the collaborative care group than in the usual care group (86.5% vs. 66.7%, p = 0.01).","[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Roustit', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France. MRoustit@chu-grenoble.fr.'}, {'ForeName': 'Marie-Camille', 'Initials': 'MC', 'LastName': 'Chaumais', 'Affiliation': 'Faculty of Pharmacy, Paris-Sud University, 92290, Châtenay Malabry, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chapuis', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gairard-Dory', 'Affiliation': 'Pharmacy Department, Strasbourg University Hospital, 67000, Strasbourg, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hadjadj', 'Affiliation': 'Health Products Division, Bordeaux University Hospital, 33600, Pessac, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Chanoine', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Allenet', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Sitbon', 'Affiliation': 'INSERM UMR_S 999, Marie Lannelongue Surgery Center, 92350, Le Plessis Robinson, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pison', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Bedouch', 'Affiliation': 'Faculty of Medicine and Pharmacy, Grenoble Alpes University, 38000, Grenoble, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical pharmacy,['10.1007/s11096-020-01047-8']
1049,31219150,"Association Between Single-Nucleotide Polymorphisms in HLA Alleles and Human Immunodeficiency Virus Type 1 Viral Load in Demographically Diverse, Antiretroviral Therapy-Naive Participants From the Strategic Timing of AntiRetroviral Treatment Trial.","The impact of variation in host genetics on replication of human immunodeficiency virus type 1 (HIV-1) in demographically diverse populations remains uncertain. In the current study, we performed a genome-wide screen for associations of single-nucleotide polymorphisms (SNPs) to viral load (VL) in antiretroviral therapy-naive participants (n = 2440) with varying demographics from the Strategic Timing of AntiRetroviral Treatment (START) trial. Associations were assessed using genotypic data generated by a customized SNP array, imputed HLA alleles, and multiple linear regression. Genome-wide significant associations between SNPs and VL were observed in the major histocompatibility complex class I region (MHC I), with effect sizes ranging between 0.14 and 0.39 log10 VL (copies/mL). Supporting the SNP findings, we identified several HLA alleles significantly associated with VL, extending prior observations that the (MHC I) is a major host determinant of HIV-1 control with shared genetic variants across diverse populations and underscoring the limitations of genome-wide association studies as being merely a screening tool.",2019,Genome-wide significant associations between SNPs and VL were observed in the major histocompatibility complex class,"['antiretroviral therapy-naive participants (n = 2440) with varying demographics from the Strategic Timing of AntiRetroviral Treatment (START) trial', 'major histocompatibility complex class', 'HLA Alleles and Human Immunodeficiency']",[],[],"[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021051', 'cui_str': 'Immunodeficiency disorder'}]",[],[],2440.0,0.0452578,Genome-wide significant associations between SNPs and VL were observed in the major histocompatibility complex class,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Ekenberg', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Man-Hung', 'Initials': 'MH', 'LastName': 'Tang', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Zucco', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Murray', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Cameron Ross', 'Initials': 'CR', 'LastName': 'MacPherson', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Laboratory of Human Retrovirology and Immunoinformatics, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Bethesda, Maryland.'}, {'ForeName': 'Brad T', 'Initials': 'BT', 'LastName': 'Sherman', 'Affiliation': 'Laboratory of Human Retrovirology and Immunoinformatics, Leidos Biomedical Research, Frederick National Laboratory for Cancer Research, Bethesda, Maryland.'}, {'ForeName': 'Marcelo H', 'Initials': 'MH', 'LastName': 'Losso', 'Affiliation': 'Hospital General de Agudos JM Ramos, Buenos Aires, Argentina.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Desmond Tutu HIV Foundation Clinical Trials Unit, Cape Town, South Africa.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'Infectious Diseases Service and irsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, University of Paris Diderot, Sorbonne Paris Cité, and Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Nureen', 'Initials': 'N', 'LastName': 'Jina', 'Affiliation': 'Clinical HIV Research Unit, Wits Health Consortium, Department of Medicine, University of the Witwatersrand, Helen Joseph Hospital, Themba Lethu Clinic, Johannesburg, South Africa.'}, {'ForeName': 'Cissy M', 'Initials': 'CM', 'LastName': 'Kityo', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Florence', 'Affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium.'}, {'ForeName': 'Mark N', 'Initials': 'MN', 'LastName': 'Polizzotto', 'Affiliation': 'Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis.'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Division of Clinical Research, Bethesda, Maryland.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'Centre of Excellence for Health, Immunity and Infections, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz294']
1050,32057371,Ticagrelor With or Without Aspirin After PCI: The TWILIGHT Platelet Substudy.,"BACKGROUND


An evolving strategy in the setting of percutaneous coronary intervention (PCI) involves withdrawal of acetylsalicylic acid (ASA), or aspirin, while maintaining P2Y 12  inhibition. However, the pharmacodynamic effects of this approach on blood thrombogenicity and platelet reactivity remain unknown.
OBJECTIVES


This study sought to compare the antithrombotic potency of ticagrelor alone versus ticagrelor plus ASA among high-risk patients undergoing PCI with drug-eluting stents.
METHODS


This was a mechanistic substudy within the TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention) trial, which randomized patients undergoing PCI to ticagrelor plus placebo versus ticagrelor plus ASA following 3 months of dual antiplatelet therapy. Substudy participants were enrolled after randomization, at which time ex vivo assays to quantify thrombus size under dynamic flow conditions and platelet reactivity were performed. Pharmacodynamic assessments were repeated 1 to 6 months thereafter. The primary endpoint was thrombus size at the post-randomization visit with platelet reactivity following stimuli to arachidonic acid, collagen, adenosine diphosphate, and thrombin as secondary endpoints. Results were analyzed using analysis of covariance.
RESULTS


A total of 51 patients were enrolled, among whom 42 underwent perfusion assays at baseline and follow-up with a median time between studies of 1.5 months. The adjusted mean difference in post-randomization thrombus area was similar between groups: -218.2 μm 2  (95% confidence interval [CI]: -575.9 to 139.9 μm 2 ; p = 0.22). Markers sensitive to cyclo-oxygenase-1 blockade, including platelet reactivity in response to arachidonic acid (mean difference: 10.9 U; 95% CI: 1.9 to 19.9 U) and collagen (mean difference: 9.8 U; 95% CI: 0.8 to 18.8 U) stimuli were higher among patients receiving placebo, whereas levels of platelet reactivity were similar with adenosine diphosphate and thrombin.
CONCLUSIONS


Among high-risk patients receiving drug-eluting stents, the antithrombotic potency of ticagrelor monotherapy is similar to that of ticagrelor plus ASA with respect to ex vivo blood thrombogenicity, whereas markers sensitive to cyclo-oxygenase-1 blockade are increased in the absence of ASA. (Platelet Substudy of the TWILIGHT Trial; NCT04001374).",2020,"Markers sensitive to cyclo-oxygenase-1 blockade, including platelet reactivity in response to arachidonic acid (mean difference: 10.9 U; 95% CI: 1.9 to 19.9 U) and collagen (mean difference: 9.8 U; 95% CI: 0.8 to 18.8 U) stimuli were higher among patients receiving placebo, whereas levels of platelet reactivity were similar with adenosine diphosphate and thrombin.
","['High-Risk Patients', 'A total of 51 patients were enrolled, among whom 42 underwent perfusion assays at baseline and follow-up with a median time between studies of 1.5\xa0months', 'high-risk patients receiving drug-eluting stents', 'high-risk patients undergoing PCI with drug-eluting stents']","['Ticagrelor With or Without Aspirin', 'ticagrelor', 'placebo', 'Ticagrelor With Aspirin', 'acetylsalicylic acid (ASA), or aspirin', 'TWILIGHT', 'ticagrelor plus ASA', 'PCI to ticagrelor plus placebo', 'percutaneous coronary intervention (PCI']","['levels of platelet reactivity', 'antithrombotic potency', 'blood thrombogenicity and platelet reactivity', 'thrombus size at the post-randomization visit with platelet reactivity following stimuli to arachidonic acid, collagen, adenosine diphosphate, and thrombin as secondary endpoints']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0005768'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",51.0,0.327655,"Markers sensitive to cyclo-oxygenase-1 blockade, including platelet reactivity in response to arachidonic acid (mean difference: 10.9 U; 95% CI: 1.9 to 19.9 U) and collagen (mean difference: 9.8 U; 95% CI: 0.8 to 18.8 U) stimuli were higher among patients receiving placebo, whereas levels of platelet reactivity were similar with adenosine diphosphate and thrombin.
","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'M Urooj', 'Initials': 'MU', 'LastName': 'Zafar', 'Affiliation': 'Atherothrombosis Research Unit, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Ginés', 'Initials': 'G', 'LastName': 'Escolar', 'Affiliation': 'Atherothrombosis Research Unit, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.'}, {'ForeName': 'Samin K', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Annapoorna S', 'Initials': 'AS', 'LastName': 'Kini', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Joyce', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Vogel', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Farhan', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gurbel', 'Affiliation': 'Inova Center for Thrombosis Research and Translational Medicine, Falls Church, Virginia.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Badimon', 'Affiliation': 'Atherothrombosis Research Unit, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.056']
1051,32441643,Tocilizumab in giant cell arteritis: differences between the GiACTA trial and a multicentre series of patients from the clinical practice.,"OBJECTIVES


A potential point of concern among clinicians is whether results derived from the clinical trials can be reasonably applied or generalised to a definable group of patients seen in real world. It can be the case of the GiACTA study that is a phase III randomised controlled trial of tocilizumab (TCZ) in giant cell arteritis (GCA). To address this question, we compared the clinical features and the responses to TCZ from the GiACTA trial patients with those from a series of GCA seen in the daily clinical practice.
METHODS


Comparative study of clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134). The diagnosis of GCA in the GiACTA trial was established by the ACR modified criteria whereas in the series of real-world patients it was made by using the ACR criteria, a positive biopsy of temporal artery or the presence of imaging techniques consistent with large-vessel vasculitis in individuals who presented cranial symptoms of GCA. GiACTA trial patients received subcutaneous TCZ (162 mg every 1 or 2 weeks) whereas those from the clinical practice series were treated using standard IV dose (8 mg/kg/month) or subcutaneous (162 mg/week).
RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial. Despite clinical differences, TCZ was equally effective in both GiACTA trial and clinical practice patients. However, serious infections were more commonly observed in GCA patients recruited from the clinical practice.
CONCLUSIONS


Despite clinical differences with patients recruited in clinical trials, data from real-life patients confirm the efficacy of TCZ in GCA.",2020,"RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial.","['giant cell arteritis', 'clinical features between patients from the GiACTA trial (overall n=251) and those from a multicentre series of real-world GCA patients undergoing TCZ therapy (n=134', 'GiACTA trial patients with those from a series of GCA seen in the daily clinical practice']","['subcutaneous TCZ', 'TCZ', 'conventional immunosuppressive therapy (mainly methotrexate', 'Tocilizumab', 'tocilizumab (TCZ']",['serious infections'],"[{'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C4510396', 'cui_str': 'Tocilizumab therapy'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.0362626,"RESULTS


Real-life patients undergoing TCZ were older with longer disease duration and higher values of ESR and had received conventional immunosuppressive therapy (mainly methotrexate) more commonly than those included in the GiACTA trial.","[{'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Calderón-Goercke', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Castañeda', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Aldasoro', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario de Navarra, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Villa', 'Affiliation': 'Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Prieto-Peña', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Atienza-Mateo', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Patiño', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Moriano', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial Universitario de León, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Romero-Yuste', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario Pontevedra, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Narváez', 'Affiliation': 'Department of Rheumatology, Hospital de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Gómez-Arango', 'Affiliation': 'Department of Rheumatology, Hospital Alto Deba, Mondragón, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Pérez-Pampín', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Melero', 'Affiliation': 'Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Becerra-Fernández', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.'}, {'ForeName': 'Marcelino', 'Initials': 'M', 'LastName': 'Revenga', 'Affiliation': 'Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Álvarez-Rivas', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Galisteo', 'Affiliation': 'Department of Rheumatology, Hospital Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Sivera', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Elda, Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Olivé-Marqués', 'Affiliation': 'Department of Rheumatology, Hospital Trías i Pujol, Badalona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Álvarez Del Buergo', 'Affiliation': 'Department of Rheumatology, Hospital Río Carrión, Palencia, Spain.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Marena-Rojas', 'Affiliation': 'Department of Rheumatology, Hospital La Mancha Centro, Alcázar de San Juan, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernández-López', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Juan Canalejo, A Coruña, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Navarro', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Raya', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Galindez-Agirregoikoa', 'Affiliation': 'Department of Rheumatology, Hospital de Basurto, Bilbao, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arca', 'Affiliation': 'Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Solans-Laqué', 'Affiliation': 'Department of Internal Medicine, Hospital Valle de Hebrón, Barcelona, Spain.'}, {'ForeName': 'Arantxa', 'Initials': 'A', 'LastName': 'Conesa', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Castellón, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hidalgo', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial Universitario de Salamanca, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Vázquez', 'Affiliation': 'Department of Rheumatology, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'José Andrés', 'Initials': 'JA', 'LastName': 'Román-Ivorra', 'Affiliation': 'Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Loricera', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Lluch', 'Affiliation': 'Department of Rheumatology, Hospital Mateu Orfila, Menorca, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Manrique-Arija', 'Affiliation': 'Department of Rheumatology, Hospital Regional de Málaga, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Vela', 'Affiliation': 'Department of Rheumatology, Hospital General Universitario de Alicante, Spain.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'De Miguel', 'Affiliation': 'Department of Rheumatology, Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Torres-Martín', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial de Ávila, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Nieto', 'Affiliation': 'Department of Rheumatology, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ordas-Calvo', 'Affiliation': 'Department of Rheumatology, Hospital Cabueñes, Gijón, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Salgado-Pérez', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Ourense, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Luna-Gomez', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Nuestra Señora de la Candelaria, Tenerife, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Toyos-Sáenz de Miera', 'Affiliation': 'Department of Rheumatology, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Nagore', 'Initials': 'N', 'LastName': 'Fernández-Llanio', 'Affiliation': 'Department of Rheumatology, Hospital Arnau de Vilanova, Lérida, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García', 'Affiliation': 'Department of Rheumatology, Hospital Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Larena', 'Affiliation': 'Department of Rheumatology, Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'González-Vela', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Corrales', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Varela-García', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid; Cátedra UAM-Roche, EPID-Future, Universidad Autónoma (UAM), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Aurrecoechea', 'Affiliation': 'Department of Rheumatology, Hospital de Sierrallana, Torrelavega, Cantabria, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Rheumatology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Manzanares', 'Affiliation': 'Department of Rheumatology, Hospital Universitario de Torrevieja, Alicante, Spain.'}, {'ForeName': 'Norberto', 'Initials': 'N', 'LastName': 'Ortego', 'Affiliation': 'Department of Rheumatology and Internal Medicine, Hospital San Cecilio, Granada, Spain.'}, {'ForeName': 'Sabela', 'Initials': 'S', 'LastName': 'Fernández', 'Affiliation': 'Department of Rheumatology, Hospital Universitario San Agustín, Avilés, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ortiz-Sanjuán', 'Affiliation': 'Department of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Corteguera', 'Affiliation': 'Department of Rheumatology, Complejo Asistencial de Ávila, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Hernández', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain.'}, {'ForeName': 'Miguel Á', 'Initials': 'MÁ', 'LastName': 'González-Gay', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. miguelaggay@hotmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Departments of Rheumatology, Internal Medicine and Pathology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. rblanco@humv.es.'}]",Clinical and experimental rheumatology,[]
1052,31443961,"Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial.","BACKGROUND


Docetaxel combined with androgen deprivation therapy (ADT) has improved patient survival for advanced prostate cancer (PCa).
OBJECTIVE


This randomised trial aimed to evaluate whether six courses of docetaxel improved biochemical disease-free survival (BDFS) after radical radiotherapy (RT) for intermediate- or high-risk PCa patients.
DESIGN, SETTING, AND PARTICIPANTS


A total of 376 patients were randomised in this multinational phase III study, and received either six cycles of adjuvant docetaxel 75 mg/m 2  every 3 wk without continuous prednisone (arm A, n = 188) or surveillance (arm B, n = 188) after RT (NTC006653848). Neoadjuvant/adjuvant ADT was mandatory for all the patients. The primary endpoint was rising prostate-specific antigen (PSA) ≥2 ng/ml above the nadir PSA value. Intermediate- or high-risk PCa was defined as T2 with a Gleason score (GS) of 4 + 3, PSA > 10; T2, GS 8-10, ≤ 70 ng/ml; or any T3. The patients were followed for 5 yr by assessing PSA levels every 3 mo for 2 yr and every 6 mo thereafter.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The study power was 89% to detect a difference in BDFS between groups, and the sample size calculation accounted for the T2/T3 distribution, where a 12%/15% difference in BDFS was assumed for the T2/T3 patients.
RESULTS AND LIMITATIONS


All six cycles were completed in 147 (78%) of the patients in arm A. The median age was 67 yr in both treatment groups, 75% had T3 disease, and 47% had GS 8-10. The median follow-up was 59 mo (range 1-111 mo). The primary endpoint was observed for 58 patients in arm A (docetaxel) and for 57 patients in arm B (surveillance). The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups. The 5-yr estimated biochemical progression rates were 31% for arm A and 28% for arm B. Febrile neutropenia occurred in 16% of the docetaxel patients. No deaths were related to the docetaxel treatment. There were 43 deaths during the trial, including 20 in arm A and 23 in arm B, of which nine and seven, respectively, were due to PCa. The hazard ratio from Cox multivariate analysis for PSA progression of arm A (docetaxel) versus arm B (surveillance) was 1.14 (95% confidence interval 0.79-1.64, p = 0.5).
CONCLUSIONS


Adjuvant docetaxel without prednisone did not improve BDFS after radical RT with ADT for intermediate- or high-risk PCa.
PATIENT SUMMARY


We compared six cycles of adjuvant docetaxel given after radical external radiotherapy plus androgen deprivation therapy to surveillance in intermediate- and high-risk localised prostate cancer. We found no overall benefit in this setting.",2019,The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups.,"['intermediate- and high-risk localised prostate cancer', 'median age was 67\u202fyr in both treatment groups, 75% had T3 disease, and 47% had GS 8-10', 'advanced prostate cancer (PCa', 'A total of 376 patients', 'intermediate- or high-risk PCa patients']","['adjuvant docetaxel', 'Docetaxel Versus Surveillance', 'Docetaxel combined with androgen deprivation therapy (ADT', 'docetaxel', 'Radical Radiotherapy', 'docetaxel without prednisone', 'radical external radiotherapy plus androgen deprivation therapy', 'radical radiotherapy (RT', 'adjuvant docetaxel 75\u202fmg/m 2  every 3 wk without continuous prednisone', 'Neoadjuvant/adjuvant ADT']","['5-yr estimated biochemical progression rates', 'BDFS curves', 'BDFS', 'biochemical disease-free survival (BDFS', 'Febrile neutropenia']","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}]",376.0,0.126569,The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups.,"[{'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland. Electronic address: pirkko-liisa.kellokumpu-lehtinen@tuni.fi.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hjälm-Eriksson', 'Affiliation': 'Department of Surgery, Capio S.t Görans Hospital, Stockholm, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg-Karlsson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Åström', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Franzen', 'Affiliation': 'Sundsvall University Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Fransson', 'Affiliation': 'Gävle Central Hospital, Gävle, Sweden.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Leskinen', 'Affiliation': 'Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Mihalj', 'Initials': 'M', 'LastName': 'Zeke', 'Affiliation': 'Växjö Central Hospital, Växjö, Sweden.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Huttunen', 'Affiliation': '4Pharma, Turku, Finland.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.08.010']
1053,31415306,"Maternal Depressive Symptoms and Perceived Picky Eating in a Low-Income, Primarily Hispanic Sample.","OBJECTIVE


Feeding concerns are common in the first 2 years of life and typically reflect maternal perceptions occurring within the larger context of the parent-child relationship. We aimed to determine whether (1) maternal depressive systems predicted perceived picky eating, mediated by maternal negative perceptions; (2) receipt of the Video Interaction Project (VIP) parenting intervention impacted perceived picky eating through this pathway; and (3) perceived picky eating was associated with child growth or subsequent dietary patterns.
METHODS


We performed a partial longitudinal analysis of 187 low-income, predominantly Hispanic mother-child dyads enrolled in a randomized controlled trial of the VIP. Mother-infant dyads were enrolled postpartum in an urban public hospital. Participants randomized to the VIP met with an interventionist on days of well-child visits; sessions were designed to facilitate interactions in play and shared reading through provision of learning materials and review of videotaped parent-child interaction; the curriculum did not contain feeding-specific elements. We used structural equation modeling to determine direct, indirect, and total effects of maternal depressive symptoms, maternal negative perceptions, and the VIP on perceived picky eating. We then tested associations between perceived picky eating and (1) child growth, using multivariable linear regression and multilevel modeling; and (2) subsequent child dietary consumption, using multivariable multinomial logistic regression.
RESULTS


Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders. This effect was partially mediated by maternal negative perceptions (indirect effect: β = 0.06, p = 0.04). When used in the model as the predictor, the VIP had a significant total effect on perceived picky eating (β = -0.16, p = 0.02), which was partially mediated by maternal depressive symptoms and negative perceptions (indirect effect: β = -0.05, p = 0.02). Perceived picky eating was not associated with child diet at age 2 years or adiposity from 6 months to 3 years.
CONCLUSION


Maternal concerns about picky eating may reflect deeper depressive symptoms and negative perceptions of her child's behavior. Interventions designed to facilitate positive parenting in general may lessen feeding-specific concerns, such as picky eating. Although reassurance about growth and nutritional outcomes for children perceived as picky eaters is appropriate, clinicians should also consider probing for underlying symptoms of depression that could lead to eating concerns.",2019,"RESULTS


Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders.","['Mother-infant dyads were enrolled postpartum in an urban public hospital', '187 low-income, predominantly Hispanic mother-child dyads enrolled']",['Video Interaction Project (VIP) parenting intervention impacted perceived picky eating through this pathway; and (3) perceived picky eating was associated with child growth or subsequent dietary patterns'],"['Perceived picky eating', 'Maternal Depressive Symptoms and Perceived Picky Eating', 'negative maternal perceptions', 'maternal depressive symptoms and negative perceptions', 'perceived picky eating']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",187.0,0.0759602,"RESULTS


Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Canfield', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Carolyn Brockmeyer', 'Initials': 'CB', 'LastName': 'Cates', 'Affiliation': 'Department of Psychology, State University of New York at Purchase, Harrison, NY.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weisleder', 'Affiliation': 'Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Samantha Berkule', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000715']
1054,32133910,Increased dopamine availability magnifies nicotine effects on cognitive control: A pilot study.,"INTRODUCTION AND OBJECTIVES


The ability to adapt to new task demands flexibly and to stabilise performance in the presence of distractors is termed cognitive control and is mediated by dopaminergic and cholinergic neurotransmission. We aimed to test the hypothesis that the effect of the cholinergic agonist nicotine on cognitive control depends on baseline dopamine levels.
METHODS


Thirty-eight healthy non-smokers (16 males;  M age =24.05 years) performed a cognitive control task including distractor and switch trials twice. Subjects were split into two parallel groups. One group received 2 g of L-tyrosine two hours prior to testing to manipulate dopamine availability experimentally, while the other group received placebo on both days. One hour later, both groups received in a within-subject design: on one day, a 7 mg nicotine patch; on the other day, a matched placebo. Response time costs for distractor and switch trials served as measures of cognitive stability and flexibility.
RESULTS


Nicotinic modulation reduced response time costs in switch trials and increased costs in distractor trials (nicotine×condition,  p =0.027) with a trend-wise interaction between nicotine, L-tyrosine and trial type (nicotine×L-tyrosine×condition,  p =0.068), which was due to stronger nicotine effects under L-tyrosine.
CONCLUSIONS


Our data provide preliminary evidence that nicotine has opponent effects on cognitive stability and flexibility. Subjects who received the dopamine precursor L-tyrosine were more prone to nicotine effects on behaviours, which are improvements in cognitive flexibility at the cost of decreased cognitive stability.",2020,"Subjects who received the dopamine precursor L-tyrosine were more prone to nicotine effects on behaviours, which are improvements in cognitive flexibility at the cost of decreased cognitive stability.","['Thirty-eight healthy non-smokers (16 males;  M age =24.05 years', 'cognitive control']","['cholinergic agonist nicotine', 'dopamine precursor L-tyrosine', 'placebo', 'nicotine', 'nicotine patch', 'cognitive control task including distractor and switch trials twice']","['cognitive stability and flexibility', 'cognitive flexibility', 'Response time costs', 'response time costs']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0242894', 'cui_str': 'Acetylcholine Agonists'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",38.0,0.0265435,"Subjects who received the dopamine precursor L-tyrosine were more prone to nicotine effects on behaviours, which are improvements in cognitive flexibility at the cost of decreased cognitive stability.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ahrens', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Laux', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Müller', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christiane M', 'Initials': 'CM', 'LastName': 'Thiel', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120907989']
1055,32049319,Comparison of Tightly Controlled Dose Reduction of Biologics With Usual Care for Patients With Psoriasis: A Randomized Clinical Trial.,"Importance


Biologics revolutionized the treatment of psoriasis. Biologics are given in a fixed dose, but lower doses might be possible.
Objective


To investigate whether dose reduction (DR) of biologics in patients with stable psoriasis is noninferior to usual care (UC).
Design, Setting, and Participants


This pragmatic, open-label, prospective, controlled, noninferiority randomized clinical trial was conducted from March 1, 2016, to July 22, 2018, at 6 dermatology departments in the Netherlands. A total of 120 patients with plaque psoriasis and stable low disease activity who were receiving treatment with adalimumab, etanercept, or ustekinumab were studied.
Interventions


Patients were randomized 1:1 to DR (n = 60) or UC (n = 60). In the DR group, injection intervals were prolonged stepwise, leading to 67% and 50% of the original dose.
Main Outcomes and Measures


The primary outcome was between-group difference in disease activity corrected for baseline at 12 months compared with the predefined noninferiority margin of 0.5. Secondary outcomes were Psoriasis Area and Severity Index (PASI) score and health-related quality of life (including Dermatology Life Quality Index [DLQI] and Medical Outcomes Study 36-Item Short Form Health Survey scores), proportion of patients with short and persistent flares (defined as PASI and/or DLQI scores >5 for ≥3 months), and proportion of patients with successful dose tapering.
Results


Of 120 patients (mean [SD] age, 54.0 [13.2] years; 82 [68%] male), 2 patients were lost to follow-up, 2 patients had a protocol violation, and 5 patients had a protocol deviation, leaving 111 patients for the per-protocol analysis (53 in the DR group and 58 in the UC group). The median PASI scores at month 12 were 3.4 (interquartile range [IQR], 2.2-4.5) in the DR group and 2.1 (IQR, 0.6-3.6) in the UC group (mean difference, 1.2; 95% CI, 0.7-1.8). This indicates that noninferiority was not demonstrated for DR compared to UC. The median DLQI score at month 12 was 1.0 (IQR, 0.0-2.0) in the DR group and 0.0 (IQR, 0.0-2.0) in the UC group (mean difference, 0.8; 95% CI, 0.3-1.3), indicating noninferiority for DR compared with UC. No significant difference was found regarding persistent flares between groups (n = 5 in both groups). Twenty-eight patients (53%; 95% CI, 39%-67%) in the DR group tapered their dose successfully at 12 months. No severe adverse events related to the intervention occurred.
Conclusions and Relevance


In this trial, noninferiority was not demonstrated for DR of adalimumab, etanercept, and ustekinumab based on the PASI in patients with psoriasis compared with UC with the chosen noninferiority margin. However, the strategy was noninferior based on the DLQI. Dose tapering did not lead to persistent flares or safety issues.
Trial Registration


ClinicalTrials.gov Identifier: NCT02602925.",2020,"In this trial, noninferiority was not demonstrated for DR of adalimumab, etanercept, and ustekinumab based on the PASI in patients with psoriasis compared with UC with the chosen noninferiority margin.","['patients with stable psoriasis is noninferior to usual care (UC', 'March 1, 2016, to July 22, 2018, at 6 dermatology departments in the Netherlands', '120 patients (mean [SD] age', 'Patients With Psoriasis', '120 patients with plaque psoriasis and stable low disease activity who were receiving treatment with adalimumab, etanercept, or ustekinumab were studied', '54.0 [13.2] years; 82 [68%] male), 2 patients were lost to follow-up, 2 patients had a protocol violation, and 5 patients had a protocol deviation, leaving 111 patients for the per-protocol analysis (53 in the DR group and 58 in the UC group', 'patients with psoriasis']","['UC', 'Biologics With Usual Care']","['persistent flares', 'disease activity', 'Psoriasis Area and Severity Index (PASI) score and health-related quality of life (including Dermatology Life Quality Index [DLQI] and Medical Outcomes Study 36-Item Short Form Health Survey scores), proportion of patients with short and persistent flares (defined as PASI and/or DLQI scores >5 for ≥3 months), and proportion of patients with successful dose tapering', 'median PASI scores', 'median DLQI score', 'severe adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0587461', 'cui_str': 'Dermatology department (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.112969,"In this trial, noninferiority was not demonstrated for DR of adalimumab, etanercept, and ustekinumab based on the PASI in patients with psoriasis compared with UC with the chosen noninferiority margin.","[{'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Atalay', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Juul M P A', 'Initials': 'JMPA', 'LastName': 'van den Reek', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Alfons A', 'Initials': 'AA', 'LastName': 'den Broeder', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'Lieke J', 'Initials': 'LJ', 'LastName': 'van Vugt', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marisol E', 'Initials': 'ME', 'LastName': 'Otero', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Marcellus D', 'Initials': 'MD', 'LastName': 'Njoo', 'Affiliation': 'Department of Dermatology, Ziekenhuis Groep Twente, Hengelo, the Netherlands.'}, {'ForeName': 'Johannes M', 'Initials': 'JM', 'LastName': 'Mommers', 'Affiliation': 'Department of Dermatology, Sint Anna Ziekenhuis, Geldrop, the Netherlands.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ossenkoppele', 'Affiliation': 'Department of Dermatology, Ziekenhuis Groep Twente, Almelo, the Netherlands.'}, {'ForeName': 'Marjolein I', 'Initials': 'MI', 'LastName': 'Koetsier', 'Affiliation': 'Department of Dermatology, Gelre ziekenhuizen, Apeldoorn, the Netherlands.'}, {'ForeName': 'Maartje A', 'Initials': 'MA', 'LastName': 'Berends', 'Affiliation': 'Department of Dermatology, Slingelandziekenhuis, Doetinchem, the Netherlands.'}, {'ForeName': 'Peter C M', 'Initials': 'PCM', 'LastName': 'van de Kerkhof', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans M M', 'Initials': 'HMM', 'LastName': 'Groenewoud', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'Wietske', 'Initials': 'W', 'LastName': 'Kievit', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Elke M G J', 'Initials': 'EMGJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.4897']
1056,30626566,A Mobile Phone-Based Program to Promote Healthy Behaviors Among Adults With Prediabetes Who Declined Participation in Free Diabetes Prevention Programs: Mixed-Methods Pilot Randomized Controlled Trial.,"BACKGROUND


Despite evidence that Diabetes Prevention Programs (DPPs) can delay or prevent progression to type 2 diabetes mellitus (T2DM), few individuals with prediabetes enroll in offered programs. This may be in part because many individuals with prediabetes have low levels of autonomous motivation (ie, motivation that arises from internal sources) to prevent T2DM.
OBJECTIVE


This study aims to examine the feasibility and acceptability of a mobile health (mHealth) intervention designed to increase autonomous motivation and healthy behaviors among adults with prediabetes who previously declined participation free DPPs. In addition, the study aims to examine changes in autonomous motivation among adults offered 2 versions of the mHealth program compared with an information-only control group.
METHODS


In this 12-week, parallel, 3-arm, mixed-methods pilot randomized controlled trial, participants were randomized to (1) a group that received information about prediabetes and strategies to prevent T2DM (control); (2) a group that received a mHealth app that aims to increase autonomous motivation among users (app-only); or (3) a group that received the app plus a physical activity tracker and wireless-enabled digital scale for self-monitoring (app-plus). Primary outcome measures included rates of intervention uptake (number of individuals enrolled/number of individuals assessed for eligibility), retention (number of 12-week survey completers/number of participants), and adherence (number of device-usage days). The secondary outcome measure was change in autonomous motivation (measured using the Treatment Self-Regulation Questionnaire), which was examined using difference-in-difference analysis. Furthermore, we conducted postintervention qualitative interviews with participants.
RESULTS


Overall, 28% (69/244) of eligible individuals were randomized; of these, 80% (55/69) completed the 12-week survey. Retention rates were significantly higher among app-plus participants than participants in the other 2 study arms combined (P=.004, χ 2 ). No significant differences were observed in adherence rates between app-only and app-plus participants (43 days vs 37 days; P=.34). Among all participants, mean autonomous motivation measures were relatively high at baseline (6.0 of 7.0 scale), with no statistically significant within- or between-group differences in follow-up scores. In qualitative interviews (n=15), participants identified reasons that they enjoyed using the app (eg, encouraged self-reflection), reasons that they did not enjoy using the app (eg, did not consider personal circumstances), and strategies to improve the intervention (eg, increased interpersonal contact).
CONCLUSIONS


Among individuals with prediabetes who did not engage in free DPPs, this mHealth intervention was feasible and acceptable. Future work should (1) examine the effectiveness of a refined intervention on clinically relevant outcomes (eg, weight loss) among a larger population of DPP nonenrollees with low baseline autonomous motivation and (2) identify other factors associated with DPP nonenrollment, which may serve as additional potential targets for interventions.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03025607; https://clinicaltrials.gov/ct2/show/NCT03025607 (Archived by WebCite at http://www.webcitation.org/73cvaSAie).",2019,No significant differences were observed in adherence rates between app-only and app-plus participants (43 days vs 37 days; P=.34).,"['Adults With Prediabetes', 'individuals with prediabetes who did not engage in free DPPs', 'adults with prediabetes who previously declined participation free DPPs']","['Diabetes Prevention Programs (DPPs', 'information about prediabetes and strategies to prevent T2DM (control); (2) a group that received a mHealth app that aims to increase autonomous motivation among users (app-only); or (3) a group that received the app plus a physical activity tracker and wireless-enabled digital scale for self-monitoring (app-plus', 'Mobile Phone-Based Program', 'mobile health (mHealth) intervention']","['rates of intervention uptake (number of individuals enrolled/number of individuals assessed for eligibility), retention (number of 12-week survey completers/number of participants), and adherence (number of device-usage days', 'mean autonomous motivation measures', 'Retention rates', 'adherence rates', 'autonomous motivation and healthy behaviors', 'change in autonomous motivation (measured using the Treatment Self-Regulation Questionnaire']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.238589,No significant differences were observed in adherence rates between app-only and app-plus participants (43 days vs 37 days; P=.34).,"[{'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Griauzde', 'Affiliation': 'Veterans Affairs Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Kullgren', 'Affiliation': 'University of Michigan School of Dentistry, Ann Arbor, MI, United States.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Liestenfeltz', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, United States.'}, {'ForeName': 'Tahoora', 'Initials': 'T', 'LastName': 'Ansari', 'Affiliation': 'University of Michigan School of Public Health, Ann Arbor, MI, United States.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Johnson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Fedewa', 'Affiliation': 'University of Michigan School of Dentistry, Ann Arbor, MI, United States.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Saslow', 'Affiliation': 'University of Michigan School of Nursing, Ann Arbor, MI, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, United States.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, United States.'}]",JMIR mHealth and uHealth,['10.2196/11267']
1057,30833118,Changes in Health-Related Outcomes in Youth With Obesity in Response to a Home-Based Parent-Led Physical Activity Program.,"PURPOSE


The purpose of this study was to elucidate whether implementation of a parent-led physical activity (PA) curriculum improved health parameters in youth with obesity.
METHODS


This prospective study included 45 youth with Prader-Willi syndrome (PWS) and 66 youth classified as obese without PWS. Participants were quasi-randomly assigned to an intervention (I) group which completed PA sessions (25-45+ minutes long) 4 days/week for 24 weeks or to a control (C) group. Generalized estimating equations analyzed differences in body composition, PA, and health-related quality of life (HRQL) by youth group, time, and treatment group. A secondary analysis in the I-group compared outcomes based on whether youth showed increases (n = 12) or decreases (n = 19) of ≥2 minutes of moderate-to-vigorous PA (MVPA).
RESULTS


Body mass index increased from baseline to 24 weeks in youth with obesity (p = .032) but not in youth with PWS. There were no changes in MVPA, total PA, or body fat indicators over time. The I-group demonstrated an increase of 7.2% and 7.6% in social and school HRQL, respectively, and a 3.3% improvement in total HRQL. Youth in the I-group who increased MVPA demonstrated decreased body mass (p = .010), body mass index z-score (p = .018), and body fat mass (p = .011); these changes were not observed in those who decreased MVPA over time.
CONCLUSIONS


Participation in a parent-led PA intervention at home can positively influence HRQL in youth with obesity and/or PWS. Increases in MVPA ≥2 minutes above baseline led to decreases in body mass and fat, while maintaining lean mass.",2019,"Youth in the I-group who increased MVPA demonstrated decreased body mass (p = .010), body mass index z-score (p = .018), and body fat mass (p = .011); these changes were not observed in those who decreased MVPA over time.
","['youth with obesity', '45 youth with Prader-Willi syndrome (PWS) and 66\xa0youth classified as obese without PWS', 'youth with obesity and/or PWS']","['parent-led physical activity (PA) curriculum', 'intervention (I) group which completed PA sessions']","['Body mass index', 'body fat mass', 'body mass index z-score', 'MVPA, total PA, or body fat indicators', 'body mass', 'total HRQL', 'body composition, PA, and health-related quality of life (HRQL']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032897', 'cui_str': 'Labhart-Willi-Prader-Fanconi Syndrome'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",45.0,0.0453122,"Youth in the I-group who increased MVPA demonstrated decreased body mass (p = .010), body mass index z-score (p = .018), and body fat mass (p = .011); these changes were not observed in those who decreased MVPA over time.
","[{'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Rubin', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, Fullerton, California. Electronic address: drubin@fullerton.edu.'}, {'ForeName': 'Kathleen S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, Fullerton, California.'}, {'ForeName': 'Diobel M', 'Initials': 'DM', 'LastName': 'Castner', 'Affiliation': 'Department of Kinesiology, California State University, Fullerton, Fullerton, California.'}, {'ForeName': 'Marilyn C', 'Initials': 'MC', 'LastName': 'Dumont-Driscoll', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2018.11.014']
1058,32441691,Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors.,"BACKGROUND


Regular physical activity after breast cancer diagnosis improves survival rates and quality of life (QOL). However, breast cancer survivors rarely meet guidelines for recommended levels of physical activity. Wellness coaching interventions (WCIs) have improved exercise and health behaviors in other patient populations.
OBJECTIVES


This study assessed the feasibility and effectiveness of WCIs for increasing physical activity in breast cancer survivors; secondary measures included changes in dietary habits, weight, and QOL.
METHODS


20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment were recruited into a single-arm, 12-week WCI pilot feasibility study. The intervention was comprised of one in-person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations.
FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL. Forty percent of participants achieved the 3% postintervention weight-loss goal, but this was not sustained at 30 weeks.",2020,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","['Breast Cancer Survivors', 'breast cancer survivors', '20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment']","['WCIs', 'Wellness coaching interventions (WCIs', 'person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations', 'Wellness Coaching']","['dietary habits, weight, and QOL', 'physical activity level, dietary habits', 'survival rates and quality of life (QOL']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0242179,"FINDINGS


Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","[{'ForeName': 'Daniela L', 'Initials': 'DL', 'LastName': 'Stan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Cutshall', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Tammy F', 'Initials': 'TF', 'LastName': 'Adams', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ghosh', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kaisa C', 'Initials': 'KC', 'LastName': 'Wieneke', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Esayas B', 'Initials': 'EB', 'LastName': 'Kebede', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Donelan Dunlap', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Hazelton', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Alissa M', 'Initials': 'AM', 'LastName': 'Butts', 'Affiliation': 'Medical College of Wisconsin.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jenkins', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Bauer', 'Affiliation': 'Mayo Clinic.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.305-315']
1059,31369676,Three-dimensional evaluation of forced unilateral posterior crossbite correction in the mixed dentition: a randomized controlled trial.,"OBJECTIVES


The objectives of this study were to assess the three-dimensional (3D) treatment changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using either quad-helix or removable expansion plate appliances in the mixed dentition, and to compare the treatment changes with the three-dimensional changes occurring in age-matched untreated unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or mild orthodontic treatment need.
TRIAL DESIGN


Six-arm parallel group multicentre randomized controlled trial.
MATERIALS AND METHODS


One-hundred and thirty-five patients with unilateral posterior crossbite with functional shift were recruited. The patients were randomized by an independent person not involved in the trial. The randomization used blocks of 25, and the patients were randomized into the following five groups: quad-helix treatments in specialist orthodontic clinics (QHS), quad-helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG), and untreated crossbite (UC). Twenty-five patients with normal occlusion who served as normal controls were also included in the trial. Blinding of the outcome assessor and data analyst was accomplished. Data on all children were evaluated on an intention-to-treat basis, regarding 3D palatal surface area, palatal projection area, and palatal shell volume; two-dimensional linear measurements were registered at the same time.
RESULTS


After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG). QHS increased significantly more than EPG for the surface and projection area. The QHS and EPS had significantly higher mean difference for shell volume.
LIMITATIONS


The trial considers a short-term evaluation.
CONCLUSION


After treatment, there were no significant differences between the four treatment groups and the normal group, which implies that the surface and projection area together with the shell volume for the four treatment groups and the normal group were equivalent.
TRIAL REGISTRATION


The trial was registered with https://www.researchweb.org/is/sverige, registration number: 220751.",2020,"After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG).","['age-matched untreated unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or mild orthodontic treatment need', 'Twenty-five patients with normal occlusion who served as normal controls were also included in the trial', 'One-hundred and thirty-five patients with unilateral posterior crossbite with functional shift were recruited']","['quad-helix treatments in specialist orthodontic clinics (QHS), quad-helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG), and untreated crossbite (UC', 'three-dimensional (3D) treatment changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using either quad-helix or removable expansion plate appliances', 'unilateral posterior crossbite correction']","['surface and projection area and shell volume', 'QHS']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0266059', 'cui_str': 'Posterior crossbite (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]","[{'cui': 'C4042790', 'cui_str': 'Quad'}, {'cui': 'C0018882', 'cui_str': 'Helix (Snails)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0242385', 'cui_str': 'Crossbite'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0266059', 'cui_str': 'Posterior crossbite (disorder)'}, {'cui': 'C0243112'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0033363', 'cui_str': 'Projection'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1275563', 'cui_str': 'qHS'}]",135.0,0.218393,"After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG).","[{'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Sollenius', 'Affiliation': 'Department of Orthodontics, County Council, Halland, Halmstad, Sweden.'}, {'ForeName': 'Aljaž', 'Initials': 'A', 'LastName': 'Golež', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Primožič', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Ovsenik', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Faculty of Medicine, University of Ljubljana, Slovenia.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bondemark', 'Affiliation': 'Department of Orthodontics, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Petrén', 'Affiliation': 'Department of Orthodontics, Malmö University, Malmö, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjz054']
1060,31424235,Narrative theory III: Evolutionary narratives addressing mating motives change discounting and tobacco valuation.,"Relationships between discounting and addictive behaviors have both state- and trait-based components. Evolutionarily driven motives may trigger risk-taking behaviors, and narratives might be used to alter the temporal window of reward valuation. The current investigation-in 2 separate studies-sought to understand the basic effects of narratives on smoking behavior by examining the effect of mating narratives on the discounting rates of cigarette smokers. Using data collected online, Study 1 ( N  = 132) assessed the within-individual effect of a mating narrative describing a long-term romantic relationship on rates of discounting after being randomly assigned to 1 of 2 narratives (romance or control) and Study 2 ( N  = 273) assessed the between-individual effect of 2 mating narratives (1 describing a long-term romantic relationship and 1 describing a short-term sexual encounter) on rates of discounting, craving, and cigarette valuation after being randomly assigned to 1 of 3 motivational narratives (romance, sex, or control). Reading the romance narrative decreased rates of discounting (i.e., increased preference for larger delayed rewards), compared to a control narrative (Studies 1 and 2). In contrast, reading the sexual narrative increased discounting (i.e., decreased preference for larger delayed rewards). Moreover, the romance narrative significantly decreased craving of cigarettes while the sexual narrative increased cigarette valuation (Study 2). These findings suggest that mating narratives may be useful in manipulating the temporal window of reward valuation, relevant for altering demand and craving, and may show potential as a component of future behavioral addiction interventions. Given the small effect sizes, replicating the study in future research will be beneficial. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Moreover, the romance narrative significantly decreased craving of cigarettes while the sexual narrative increased cigarette valuation (Study 2).",['cigarette smokers'],"['Narrative theory III: Evolutionary narratives addressing mating motives change discounting and tobacco valuation', '2 mating narratives (1 describing a long-term romantic relationship and 1 describing a short-term sexual encounter']","['rates of discounting, craving, and cigarette valuation', 'craving of cigarettes']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",2019.0,0.0226181,"Moreover, the romance narrative significantly decreased craving of cigarettes while the sexual narrative increased cigarette valuation (Study 2).","[{'ForeName': 'Liqa N', 'Initials': 'LN', 'LastName': 'Athamneh', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Stein', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000315']
1061,32134436,Effects of Cataract Surgery on Melatonin Secretion in Adults 60 Years and Older: A Randomized Clinical Trial.,"Importance


Cataract surgery, which increases perception of light, may increase melatonin secretion. Melatonin secretion has been associated with depression, diabetes, cognitive impairment, and breast cancer. To date, no evidence from a randomized clinical trial exists to support this cataract surgery hypothesis.
Objective


To determine whether cataract surgery modifies the melatonin secretion at 3 months after cataract surgery in 169 adult patients.
Design, Setting, and Participants


A parallel-group randomized clinical trial was conducted at a single referral center from July 1, 2014, to June 30, 2017. Data were analyzed from January 1, 2018, to March 31, 2019. Patients were aged 60 years or older, had no history of cataract surgery, and had cataracts with grade 2 or higher nuclear opacifications based on the Lens Opacities Classification System III. Analyses were based on intention to treat.
Interventions


Patients were randomized 1:1:1:1 to receive cataract surgery using artificial clear intraocular lens (IOL) or yellow IOL. Group 1 received prompt surgery with clear IOL, group 2, prompt surgery with yellow IOL, group 3, delayed surgery with clear IOL, and group 4, delayed surgery with yellow IOL. The intervention group consisted of groups 1 and 2, and the control group consisted of groups 3 and 4.
Main Outcomes and Measures


Urinary melatonin excretion in the intervention group was measured at 3 months after surgery, and urinary melatonin excretion in the control group was measured before delayed surgery.
Results


Of the 169 randomized patients, 97 were men (57.4%). The mean (SD) age was 75.7 (6.7) years. Mean urinary melatonin excretion was calculated as standardized urinary concentration, the ratio of urinary concentration to urinary creatinine concentration (nanograms per milligram of creatinine), in the intervention group after cataract surgery. Mean urinary melatonin excretion was significantly higher than in the control group (adjusted mean difference of creatinine concentration, 0.159 log ng/mg, 95% CI, 0.045-0.273; P = .007) independent of baseline urinary melatonin excretion and potential confounders. Subgroup analysis comparing group 1 with group 3 revealed that concentration of urinary melatonin excretion in patients who received clear IOLs was higher than the control group by creatinine concentration 0.212 log ng/mg (95% CI of the difference, 0.058-0.365; P = .008). However, the difference between patients in group 2 and group 4 was not significant (adjusted mean difference for creatinine excretion, 0.083 log ng/mg, 95% CI, -0.087 to 0.253; P = .33). The difference of concentration of mean urinary melatonin excretion between patients in group 1 and those in group 2 was not significant (95% CI of the difference for creatinine concentration, -0.19 to 0.40 log ng/mg; P = .48).
Conclusions and Relevance


The findings in this study support the hypothesis that cataract surgery increases melatonin secretion. The effect of clear IOLs vs yellow IOLs on these outcomes was not shown to be different.
Trial Registration


UMIN-CTR Identifier: UMIN000014559.",2020,"Mean urinary melatonin excretion was significantly higher than in the control group (adjusted mean difference of creatinine concentration, 0.159 log ng/mg, 95% CI, 0.045-0.273; P = .007) independent of baseline urinary melatonin excretion and potential confounders.","['169 randomized patients, 97 were men (57.4', 'Patients were aged 60 years or older, had no history of cataract surgery, and had cataracts with grade 2 or higher nuclear opacifications based on the Lens Opacities Classification System III', 'Adults 60 Years and Older', '169 adult patients']","['cataract surgery using artificial clear intraocular lens (IOL) or yellow IOL', 'cataract surgery', 'prompt surgery with clear IOL, group 2, prompt surgery with yellow IOL, group 3, delayed surgery with clear IOL, and group 4, delayed surgery with yellow IOL', 'Melatonin secretion', 'Cataract Surgery']","['Melatonin Secretion', 'concentration of urinary melatonin excretion', 'melatonin secretion', 'Measures\n\n\nUrinary melatonin excretion', 'creatinine excretion', 'urinary melatonin excretion', 'Mean urinary melatonin excretion', 'concentration of mean urinary melatonin excretion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449584', 'cui_str': 'Opacification (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0221205', 'cui_str': 'Yellow color (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",169.0,0.200729,"Mean urinary melatonin excretion was significantly higher than in the control group (adjusted mean difference of creatinine concentration, 0.159 log ng/mg, 95% CI, 0.045-0.273; P = .007) independent of baseline urinary melatonin excretion and potential confounders.","[{'ForeName': 'Tomo', 'Initials': 'T', 'LastName': 'Nishi', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Saeki', 'Affiliation': 'Department of Epidemiology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kimie', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Tadanobu', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Kurumatani', 'Affiliation': 'Department of Epidemiology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Obayashi', 'Affiliation': 'Department of Epidemiology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Nahoko', 'Initials': 'N', 'LastName': 'Ogata', 'Affiliation': 'Department of Ophthalmology, Nara Medical University School of Medicine, Nara, Japan.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.0206']
1062,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8']
1063,32437507,Effect of Nivolumab vs Bevacizumab in Patients With Recurrent Glioblastoma: The CheckMate 143 Phase 3 Randomized Clinical Trial.,"Importance


Clinical outcomes for glioblastoma remain poor. Treatment with immune checkpoint blockade has shown benefits in many cancer types. To our knowledge, data from a randomized phase 3 clinical trial evaluating a programmed death-1 (PD-1) inhibitor therapy for glioblastoma have not been reported.
Objective


To determine whether single-agent PD-1 blockade with nivolumab improves survival in patients with recurrent glioblastoma compared with bevacizumab.
Design, Setting, and Participants


In this open-label, randomized, phase 3 clinical trial, 439 patients with glioblastoma at first recurrence following standard radiation and temozolomide therapy were enrolled, and 369 were randomized. Patients were enrolled between September 2014 and May 2015. The median follow-up was 9.5 months at data cutoff of January 20, 2017. The study included 57 multicenter, multinational clinical sites.
Interventions


Patients were randomized 1:1 to nivolumab 3 mg/kg or bevacizumab 10 mg/kg every 2 weeks until confirmed disease progression, unacceptable toxic effects, or death.
Main Outcomes and Measures


The primary end point was overall survival (OS).
Results


A total of 369 patients were randomized to nivolumab (n = 184) or bevacizumab (n = 185). The MGMT promoter was methylated in 23.4% (43/184; nivolumab) and 22.7% (42/185; bevacizumab), unmethylated in 32.1% (59/184; nivolumab) and 36.2% (67/185; bevacizumab), and not reported in remaining patients. At median follow-up of 9.5 months, median OS (mOS) was comparable between groups: nivolumab, 9.8 months (95% CI, 8.2-11.8); bevacizumab, 10.0 months (95% CI, 9.0-11.8); HR, 1.04 (95% CI, 0.83-1.30); P = .76. The 12-month OS was 42% in both groups. The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%). Grade 3/4 treatment-related adverse events (TRAEs) were similar between groups (nivolumab, 33/182 [18.1%]; bevacizumab, 25/165 [15.2%]), with no unexpected neurological TRAEs or deaths due to TRAEs.
Conclusions and Relevance


Although the primary end point was not met in this randomized clinical trial, mOS was comparable between nivolumab and bevacizumab in the overall patient population with recurrent glioblastoma. The safety profile of nivolumab in patients with glioblastoma was consistent with that in other tumor types.
Trial Registration


ClinicalTrials.gov Identifier: NCT02017717.",2020,"The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%).","['patients with recurrent glioblastoma compared with bevacizumab', '439 patients with glioblastoma at first recurrence following standard radiation and temozolomide therapy were enrolled, and 369 were randomized', '369 patients', 'patients with glioblastoma', 'Patients With Recurrent Glioblastoma', 'Patients were enrolled between September 2014 and May 2015', '57 multicenter, multinational clinical sites']","['nivolumab', 'immune checkpoint blockade', 'nivolumab 3 mg/kg or bevacizumab', 'Nivolumab vs Bevacizumab', 'bevacizumab']","['safety profile of nivolumab', 'survival', 'median OS (mOS', 'Grade 3/4 treatment-related adverse events (TRAEs', 'objective response rate', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",439.0,0.244696,"The objective response rate was higher with bevacizumab (23.1%; 95% CI, 16.7%-30.5%) vs nivolumab (7.8%; 95% CI, 4.1%-13.3%).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Alba A', 'Initials': 'AA', 'LastName': 'Brandes', 'Affiliation': 'AUSL-IRCCS Institute of Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Omuro', 'Affiliation': 'Department of Neurology and Yale Cancer Center, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulholland', 'Affiliation': 'University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lim', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Baehring', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Manmeet S', 'Initials': 'MS', 'LastName': 'Ahluwalia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Roth', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Bähr', 'Affiliation': 'Dr Senckenberg Institute of Neurooncology, Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Surasak', 'Initials': 'S', 'LastName': 'Phuphanich', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'De Souza', 'Affiliation': 'University of Wollongong School of Medicine, Wollongong, NSW, Australia.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Sahebjam', 'Affiliation': 'Moffitt Cancer Center, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Carleton', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tatsuoka', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Taitt', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Zwirtes', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sampson', 'Affiliation': 'Duke University Hospital, Durham, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology and Brain Tumor Center, University Hospital and University of Zurich, Zurich, Switzerland.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1024']
1064,31433518,Zoledronate for the Prevention of Bone Loss in Women Discontinuing Denosumab Treatment. A Prospective 2-Year Clinical Trial.,"Cessation of denosumab treatment is associated with increases in bone turnover above baseline values and rapid bone loss. We investigated the efficacy of zoledronate to prevent this bone loss in women with postmenopausal osteoporosis who were treated with denosumab (mean duration 2.2 years) and discontinued treatment after achieving osteopenia. Women were randomized to receive a single 5-mg infusion of zoledronate (ZOL) (n = 27) or two additional 60-mg injections of denosumab (Dmab) (n = 30). Both groups were followed for a total period of 24 months. At 24 months lumbar spine-bone mineral density (LS-BMD) was not different from baseline in the ZOL group, but decreased in the Dmab group by (mean ± SD) 4.82% ± 0.7% (p < 0.001) from the 12-month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025). Results of femoral neck (FN)-BMD changes were similar. ZOL infusion was followed by small but significant increases in serum procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide of type 1 collagen (CTX) during the first year and stabilization thereafter. In the Dmab group, bone turnover marker values did not change during the first 12 months but increased significantly at 15 months and in the majority of women these remained elevated at 24 months. Neither baseline nor 12-month bone turnover marker values were associated with BMD changes in either group of women. In the Dmab group, three patients sustained vertebral fractures (two patients multiple clinical, one patient morphometric) whereas one patient in the ZOL group sustained clinical vertebral fractures 12 months after the infusion. In conclusion, a single intravenous infusion of ZOL given 6 months after the last Dmab injection prevents bone loss for at least 2 years independently of the rate of bone turnover. Follow-up is recommended, because in a few patients ZOL treatment might not have the expected effect at 2 years. © 2019 American Society for Bone and Mineral Research.",2019,"At 24 months LS-BMD was not different from baseline in the ZOL group, but decreased in the Dmab group by 4.82 ± 0.7% (p < 0.001) from the 12-month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025).","['Women Discontinuing Denosumab Treatment', 'women with postmenopausal osteoporosis who were treated with denosumab (mean duration 2.2\u2009years) and discontinued treatment after achieving osteopenia']","['denosumab', 'zoledronate', 'single zoledronate 5\u2009mg infusion (n\xa0=\xa027) or two additional denosumab 60\u2009mg injections', 'Zoledronate']","['serum Procollagen type 1\u2009N-terminal propeptide (P1NP) and C-terminal telopeptide of type 1 collagen (CTX', 'bone turnover marker values', 'Bone Loss', '12-month bone turnover marker values', 'BMD changes', 'vertebral fractures', 'bone loss', 'bone turnover above baseline values and rapid bone loss']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",,0.0319117,"At 24 months LS-BMD was not different from baseline in the ZOL group, but decreased in the Dmab group by 4.82 ± 0.7% (p < 0.001) from the 12-month value; the difference in BMD changes between the two groups, the primary endpoint of the study, was statistically significant (p = 0.025).","[{'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Department of Pharmacology, Faculty of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section of Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3853']
1065,31398441,Cardiac autonomic activity during sleep deprivation with and without caffeine administration.,"Caffeine is often consumed to mitigate degraded alertness associated with sleep deprivation. Both caffeine and sleep deprivation have been implicated in cardiovascular disease, but evidence is largely anecdotal. We determined the effects of sleep deprivation and caffeine on markers of cardiac autonomic activity. Twelve healthy young adults completed an 18-day laboratory study. They were exposed to three 48 h sessions of acute total sleep deprivation (TSD), each separated by three recovery days. In randomized, counter-balanced order, subjects received 0 mg (placebo), 200 mg, or 300 mg of caffeine at 12 h intervals during each sleep deprivation session. Every 2 h during scheduled wakefulness, a 15-minute neurobehavioral task battery was administered, during which heart rate (HR) and the high frequency (HF) component of the HR variability power spectrum (HF-HRV) were measured. Caffeine administration decreased HR and increased HF-HRV, indicating elevated parasympathetic activity. The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose. There was no significant effect of 48 h of TSD on HR, whereas there was a small increase across hours awake in HF-HRV. There was no significant interaction of TSD with caffeine. Circadian rhythmicity in HR and HF-HRV surpassed the magnitude of the effects of caffeine and TSD. Caffeine and acute TSD thus produced only modest changes in cardiac autonomic activity, unlikely to have immediate clinical implications in healthy young adults. However, further research is needed to determine the long-term effects of chronic exposure to sleep loss and/or caffeine on cardiac health, and to determine the generalizability of our findings to non-healthy populations.",2019,The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose.,"['healthy young adults', 'Twelve healthy young adults completed an 18-day laboratory study']","['caffeine', 'mg (placebo', 'Caffeine']","['acute total sleep deprivation (TSD', 'autonomic activity', 'elevated parasympathetic activity', 'Cardiac autonomic activity', 'cardiac autonomic activity', 'HR and increased HF-HRV']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0039373', 'cui_str': 'Hexosaminidase A Deficiency Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",12.0,0.055929,The 300 mg caffeine dose did not significantly affect autonomic activity to a greater extent than the 200 mg dose.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crooks', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Department of Physical Therapy, Eastern Washington University, 310 N. Riverpoint Blvd., Spokane, WA 99202-0002, USA. Electronic address: ecrooks@ewu.edu.'}, {'ForeName': 'Devon A', 'Initials': 'DA', 'LastName': 'Hansen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: devon.hansen@wsu.edu.'}, {'ForeName': 'Brieann C', 'Initials': 'BC', 'LastName': 'Satterfield', 'Affiliation': 'Social, Cognitive, and Affective Neuroscience Lab, University of Arizona College of Medicine, PO Box 245002, Tucson, AZ 85724-5002, USA. Electronic address: bsatterfield@psychiatry.arizona.edu.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Layton', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: layton@wsu.edu.'}, {'ForeName': 'Hans P A', 'Initials': 'HPA', 'LastName': 'Van Dongen', 'Affiliation': 'Sleep and Performance Research Center, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA; Elson S. Floyd College of Medicine, Washington State University, PO Box 1495, Spokane, WA 99210-1495, USA. Electronic address: hvd@wsu.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2019.112643']
1066,31420374,Higher negative emotions in response to cigarette pictorial warning labels predict higher quit intentions among smokers.,"BACKGROUND


Cigarette pictorial warning labels (PWLs) could produce stronger quit intentions than text-only warning labels (TWLs) due to greater emotional arousal. Yet, it remains unclear whether PWLs that elicit different levels of emotions produce different outcomes. To better understand the role of negative emotions in the effects of PWLs, this study developed two sets of PWLs arousing different emotional levels (high vs low) but equally high on informativeness and compared them to each other and to the current TWLs.
METHODS


Adult US smokers (n=1503) were randomised to view nine high-emotion-arousing or low-emotion-arousing PWLs or TWLs. After each label, participants reported the negative emotions they felt while looking at the label. After seeing all the labels, participants reported their intentions to quit smoking. Mediation analyses tested whether message condition influenced quit intentions indirectly through negative emotions.
RESULTS


Compared with TWLs, PWLs produced higher levels of negative emotions (b=0.27, SE=0.04, p<0.001). Compared with low-emotion arousing PWLs, high-emotion-arousing PWLs produced higher levels of negative emotions (b = 0.24, SE=0.07, p<0.001). Higher negative emotions predicted stronger quit intentions (b=0.20, SE=0.03, p<0.001). Negative emotions mediated the effects of PWLs versus TWLs and high-emotion-arousing versus low- emotion-arousing PWLs on quit intentions.
CONCLUSIONS


The results provide additional evidence for negative emotions as the mechanism through which PWLs motivate smokers to consider quitting. The findings call on the Food and Drug Administration to design and implement high-emotion-arousing cigarette warning labels.",2020,"Compared with TWLs, PWLs produced higher levels of negative emotions (b=0.27, SE=0.04, p<0.001).",['Adult US smokers (n=1503'],"['cigarette pictorial warning labels', 'Cigarette pictorial warning labels (PWLs', 'PWLs versus TWLs and high-emotion-arousing versus low- emotion-arousing PWLs', 'emotion-arousing or low-emotion-arousing PWLs or TWLs']","['intentions to quit smoking', 'negative emotions', 'Higher negative emotions predicted stronger quit intentions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}]",,0.0446065,"Compared with TWLs, PWLs produced higher levels of negative emotions (b=0.27, SE=0.04, p<0.001).","[{'ForeName': 'Yachao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Communication Studies and Department of Public Health, The College of New Jersey, Ewing, New Jersey, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, Arizona, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Owusu', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, USA lpopova1@gsu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055116']
1067,31326680,Design and rationale of a pragmatic trial integrating routine screening for atrial fibrillation at primary care visits: The VITAL-AF trial.,"Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.",2019,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","['atrial fibrillation at primary care visits', '16,000 patients in each arm', 'individuals 65 years or older during primary care visits', 'eligible patients who agree to participate during office visits using a single-lead ECG device']",['AF screening'],"['new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0527347,"Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Ashburner', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Atlas', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'McManus', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Yuchiao', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Trisini Lipsanopoulos', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Leila H', 'Initials': 'LH', 'LastName': 'Borowsky', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wyliena', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Ellinor', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Singer', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA; Department of Medicine, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Cardiovascular Research Center and Cardiac Arrhythmia Service, Massachusetts General Hospital, Boston, MA. Electronic address: slubitz@mgh.harvard.edu.'}]",American heart journal,['10.1016/j.ahj.2019.06.011']
1068,32054380,Benefits of a Dance Intervention on Balance in Adolescents with Cerebral Palsy.,"AIMS


Cerebral palsy (CP) impacts motor functions such as balance, limits of stability and walking, and may also affect other functions such as attention and rhythm production. Motor and non-motor deficits lead to difficulties in daily life activities. The main objective of this study was to evaluate the effects of a dance intervention on balance in adolescents with CP. The secondary objectives were to evaluate the effects of this intervention on walking speed, attention, and rhythm production.
METHODS


A pre-post design study with a double baseline was conducted on ten adolescents with CP in order to assess the effects of a 10-week dance intervention. The dance intervention focused on improving balance and limits of stability. Outcomes on static and dynamic balance were evaluated with clinical and laboratory tests before and after the intervention. Walking speed, attention, and rhythm production were also evaluated before and after the intervention.
RESULTS


Balance improved after the dance intervention as assessed with both the clinical tests and a laboratory test. Rhythm production also improved after the dance intervention.
CONCLUSIONS


Results suggest that a 10-week dance intervention is an effective activity to improve static and dynamic balance as well as rhythmic production in adolescents with CP.",2020,Rhythm production also improved after the dance intervention.,"['ten adolescents with CP', 'adolescents with CP', 'Adolescents with Cerebral Palsy']","['Dance Intervention', 'dance intervention']","['walking speed, attention, and rhythm production', 'balance and limits of stability', 'Rhythm production', 'static and dynamic balance', 'Walking speed, attention, and rhythm production']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033268'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}]",10.0,0.0199103,Rhythm production also improved after the dance intervention.,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Cherriere', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Martel', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sarrasin', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ballaz', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tallet', 'Affiliation': 'ToNIC Toulouse NeuroImaging Center, Université de Toulouse, Inserm, UPS, Toulouse, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lemay', 'Affiliation': 'Centre de Réadaptation Marie Enfant, Centre de Recherche du CHU Sainte Justine, Montréal, Canada.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1720053']
1069,32496526,Evaluation of a Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data: A Secondary Analysis of 2 Randomized Clinical Trials.,"Importance


The contribution of long-term intraocular pressure (IOP) variability to the development of primary open-angle glaucoma is still controversial.
Objective


To assess whether long-term IOP variability data improve a prediction model for the development of primary open-angle glaucoma (POAG) in individuals with untreated ocular hypertension.
Design, Setting, and Participants


This post hoc secondary analysis of 2 randomized clinical trials included data from 709 of 819 participants in the observation group of the Ocular Hypertension Treatment Study (OHTS) followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study (EGPS) followed up from January 1, 1997, to September 30, 2003. Data analyses were completed between January 1, 2019, and March 15, 2020.
Exposures


The original prediction model for the development of POAG included the following baseline factors: age, IOP, central corneal thickness, vertical cup-disc ratio, and pattern SD. This analysis tested whether substitution of baseline IOP with mean follow-up IOP, SD of IOP, maximum IOP, range of IOP, or coefficient of variation IOP would improve predictive accuracy.
Main Outcomes and Measures


The C statistic was used to compare the predictive accuracy of multivariable landmark Cox proportional hazards regression models for the development of POAG.
Results


Data from the OHTS consisted of 97 POAG end points from 709 of 819 participants (416 [58.7%] women; 177 [25.0%] African American and 490 [69.1%] white; mean [SD] age, 55.7 [9.59] years; median [range] follow-up, 6.9 [0.96-8.15] years). Data from the EGPS consisted of 44 POAG end points from 397 of 500 participants in the placebo group (201 [50.1%] women; 397 [100%] white; mean [SD] age, 57.8 [9.76] years; median [range] follow-up, 4.9 [1.45-5.76] years). The C statistic for the original prediction model was 0.741. When a measure of follow-up IOP was substituted for baseline IOP in this prediction model, the C statistics were as follows: mean follow-up IOP, 0.784; maximum IOP, 0.781; SD of IOP, 0.745; range of IOP, 0.741; and coefficient of variation IOP, 0.729. The C statistics in the EGPS were similarly ordered. No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
Conclusions and Relevance


Evidence from the OHTS and the EGPS suggests that long-term variability does not add substantial explanatory power to the prediction model as to which individuals with untreated ocular hypertension will develop POAG.",2020,"No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
","['African American and 490', '819 participants in the observation group of the Ocular Hypertension Treatment Study (OHTS) followed up from February 28, 1994, to June 1, 2002, and 397 of 500 participants in the placebo group of the European Glaucoma Prevention Study (EGPS) followed up from January 1, 1997, to September 30, 2003', 'individuals with untreated ocular hypertension', 'mean [SD] age, 55.7 [9.59] years; median [range] follow-up, 6.9 [0.96-8.15] years', 'group (201 [50.1%] women; 397 [100%] white; mean [SD] age, 57.8 [9.76] years; median [range] follow-up, 4.9 [1.45-5.76] years']","['Primary Open-Angle Glaucoma Prediction Model Using Long-term Intraocular Pressure Variability Data', 'long-term intraocular pressure (IOP', 'placebo']","['C statistic', 'central corneal thickness, vertical cup-disc ratio, and pattern SD', 'IOP variability']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C1299676', 'cui_str': 'Vertical cup disc ratio'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.230639,"No measure of IOP variability, when added to the prediction model that included mean follow-up IOP, age, central corneal thickness, vertical cup-disc ratio, and pattern SD, increased the C statistic by more than 0.007 in either cohort.
","[{'ForeName': 'Mae O', 'Initials': 'MO', 'LastName': 'Gordon', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'Department of Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Julia Beiser', 'Initials': 'JB', 'LastName': 'Huecker', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Margolis', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Kass', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Miglior', 'Affiliation': 'Policlinico di Monza University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'Department of Oncology, Istituto di Ricerche Farmacologiche ""Mario Negri,"" Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1902']
1070,31519975,Identification and injury to the inferior hypogastric plexus in nerve-sparing radical hysterectomy.,"Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study. However, the definite reasons for these results were unknown. This subgroup analysis compared the neural areas and impairment in the IHP uterine branches harvested during NSRH as an alternative to the IHP vesical branches between the waterjet and control groups. This study included samples from 30 eligible patients in each group of the trial NCT03020238. At least one specimen from each side of the IHP uterine branches was resected. The tissues were scanned, images were captured, and the neural component areas were calculated using the image segmentation method. Immunohistochemical staining was used to evaluate neural impairment. The control and waterjet groups had similar areas of whole tissues sent for evaluation. However, the control group had significantly fewer areas (median 272158 versus 200439 μm 2 , p = 0.044) and a lower percentage (median 4.9% versus 3.0%, p = 0.011) of neural tissues. No significant changes in immunohistochemical staining were found between the two groups. For patients with residual urine ≤100 and >100 ml at 14 days after NSRH (42 and 18 patients, respectively), there were significantly different percentages of neural tissues in the resected samples (p < 0.001). Hence, Due to the accurate identification of IHP during NSRH, the waterjet dissection technique achieved better urodynamic results.",2019,Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study.,"['nerve-sparing radical hysterectomy', '30 eligible patients in each group of the trial NCT03020238']","['Immunohistochemical staining', 'Waterjet dissection of the inferior hypogastric plexus (IHP', 'laparoscopic nerve-sparing radical hysterectomy (NSRH']","['immunohistochemical staining', 'neural tissues']","[{'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0205797', 'cui_str': 'Pelvic Plexus'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}]","[{'cui': 'C0487602', 'cui_str': 'Staining'}]",,0.0323975,Waterjet dissection of the inferior hypogastric plexus (IHP) resulted in a more rapid return of normal urodynamics than blunt dissection (control group) in patients who received laparoscopic nerve-sparing radical hysterectomy (NSRH) in a randomized controlled study.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Yalan', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Leiming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Pathology, Xuanwu Hospital, Capital Medical University, 45# Changchun Street, Beijing, 100053, China.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Kraemer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tuebingen, Calwerstr. 7, Tübingen, 72076, Germany.'}, {'ForeName': 'Jinghe', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Quancai', 'Initials': 'Q', 'LastName': 'Cui', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China. cuiqc@sina.com.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing, 100730, China. wuming@pumch.cn.'}]",Scientific reports,['10.1038/s41598-019-49856-w']
1071,31945149,Brentuximab vedotin with chemotherapy for stage III/IV classical Hodgkin lymphoma: 3-year update of the ECHELON-1 study.,"The phase 3 ECHELON-1 study demonstrated that brentuximab vedotin (A) with doxorubicin, vinblastine, and dacarbazine (AVD; A+AVD) exhibited superior modified progression-free survival (PFS) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of patients with stage III/IV classical Hodgkin lymphoma (cHL). Maturing positron emission tomography (PET)-adapted trial data highlight potential limitations of PET-adapted approaches, including toxicities with dose intensification and higher-than-expected relapse rates in PET scan after cycle 2 (PET2)-negative (PET2-) patients. We present an update of the ECHELON-1 study, including an exploratory analysis of 3-year PFS per investigator. A total of 1334 patients with stage III or IV cHL were randomized 1:1 to receive 6 cycles of A+AVD (n = 664) or ABVD (n = 670). Interim PET2 was required. At median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2- patients aged <60 years were 87.2% vs 81.0%, respectively. A beneficial trend in PET2+ patients aged <60 years on A+AVD was also observed, with a 3-year PFS rate of 69.2% vs 54.7% with ABVD. The benefit of A+AVD in the intent-to-treat population appeared independent of disease stage and prognostic risk factors. Upon continued follow-up, 78% of patients with peripheral neuropathy on A+AVD had either complete resolution or improvement compared with 83% on ABVD. These data highlight that A+AVD provides a durable efficacy benefit compared with ABVD for frontline stage III/IV cHL, consistent across key subgroups regardless of patient status at PET2, without need for treatment intensification or bleomycin exposure. This trial was registered at www.clinicaltrials.gov as #NCT01712490 (EudraCT no. 2011-005450-60).",2020,"At a median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2(-) patients aged <60 years were 87.2% versus 81.0%, respectively.","['1334 patients with stage III or IV cHL', 'Stage III/IV classical Hodgkin lymphoma', 'patients with stage III/IV classical Hodgkin lymphoma (cHL) (NCT01712490; 2011-005450-60']","['A+AVD', 'bleomycin', 'ABVD', 'brentuximab vedotin (A) with AVD (A+AVD) exhibited superior modified PFS versus ABVD', 'Brentuximab vedotin with chemotherapy']","['PFS rates', '3-year PFS rate', '3-year PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1333064', 'cui_str': 'Classical Hodgkin lymphoma (disorder)'}]","[{'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",1334.0,0.136096,"At a median follow-up of 37 months, 3-year PFS rates were 83.1% with A+AVD and 76.0% with ABVD; 3-year PFS rates in PET2(-) patients aged <60 years were 87.2% versus 81.0%, respectively.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Straus', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Długosz-Danecka', 'Affiliation': 'Department of Hematology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Alekseev', 'Affiliation': 'N. N. Petrov Scientific Research Institute of Oncology, St. Petersburg, Russian Federation.'}, {'ForeName': 'Árpád', 'Initials': 'Á', 'LastName': 'Illés', 'Affiliation': 'Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Picardi', 'Affiliation': 'Department of Advanced Biomedical Science, Federico II University Hospital, Naples, Italy.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Lech-Maranda', 'Affiliation': 'Department of Hematology, Institute of Hematology and Transfusion Medicine, Warsaw, Poland.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Smolewski', 'Affiliation': 'Department of Experimental Hematology, Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Savage', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Division of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Department of Lymphoid Malignancy, The Maria Sklodowska-Curie Memorial Institute and Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Radhakrishnan', 'Initials': 'R', 'LastName': 'Ramchandren', 'Affiliation': 'Department of Medicine, Graduate School of Medicine, The University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology Seragnoli, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hutchings', 'Affiliation': 'Department of Hematology, Finsen Centre, National Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Radford', 'Affiliation': 'Department of Medical Oncology, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Munoz', 'Affiliation': 'Department of Lymphoma/Myeloma, Banner MD Anderson Cancer Center, Gilbert, AZ.'}, {'ForeName': 'Won Seog', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.'}, {'ForeName': 'Ranjana', 'Initials': 'R', 'LastName': 'Advani', 'Affiliation': 'Department of Medicine/Oncology, Stanford Cancer Institute, Stanford, CA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'Younes', 'Affiliation': 'Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Millennium Pharmaceuticals, Inc, Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited.'}, {'ForeName': 'Keenan', 'Initials': 'K', 'LastName': 'Fenton', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA; and.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Forero-Torres', 'Affiliation': 'Seattle Genetics, Inc, Bothell, WA; and.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gallamini', 'Affiliation': 'Research and Clinical Innovation, Antoine-Lacassagne Cancer Centre, Nice, France.'}]",Blood,['10.1182/blood.2019003127']
1072,32438407,Thrombosis in patients with myeloma treated in the Myeloma IX and Myeloma XI phase 3 randomized controlled trials.,"Newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulatory drugs are at high risk of venous thromboembolism (VTE), but data are lacking from large prospective cohorts. We present thrombosis outcome data from Myeloma IX (n = 1936) and Myeloma XI (n = 4358) phase 3 randomized controlled trials for NDMM that treated transplant-eligible and transplant-ineligible patients before and after publication of thrombosis prevention guidelines. In Myeloma IX, transplant-eligible patients randomly assigned to cyclophosphamide, vincristine, doxorubicin, and dexamethasone (CVAD) induction had higher risk of VTE compared with patients treated with cyclophosphamide, thalidomide, and dexamethasone (CTD) (22.5% [n = 121 of 538] vs 16.1% [n = 89 of 554]; adjusted hazard ratio [aHR],1.46; 95% confidence interval [95% CI], 1.11-1.93). For transplant-ineligible patients, those randomly assigned to attenuated CTD (CTDa) induction had a higher risk of VTE compared with those treated with melphalan and prednisolone (MP) (16.0% [n = 68 of 425] vs 4.1% [n = 17 of 419]; aHR, 4.25; 95% CI, 2.50-7.20). In Myeloma XI, there was no difference in risk of VTE (12.2% [n = 124 of 1014] vs 13.2% [n = 133 of 1008]; aHR, 0.92; 95% CI, 0.72-1.18) or arterial thrombosis (1.2% [n = 12 of 1014] vs 1.5% [n = 15 of 1008]; aHR, 0.80; 95% CI, 0.37-1.70) between transplant-eligible pathways for patients treated with cyclophosphamide, lenalidomide, and dexamethasone (CRD) or CTD. For transplant-ineligible patients, there was no difference in VTEs between attenuated CRD (CRDa) and CTDa (10.4% [n = 95 of 916] vs 10.7% [n = 97 of 910]; aHR, 0.97; 95% CI, 0.73-1.29). However, arterial risk was higher with CRDa than with CTDa (3.1% [n = 28 of 916] vs 1.6% [n = 15 of 910]; aHR, 1.91; 95% CI, 1.02-3.57). Thrombotic events occurred almost entirely within 6 months of treatment initiation. Thrombosis was not associated with inferior progression-free survival (PFS) or overall survival (OS), apart from inferior OS for patients with arterial events (aHR, 1.53; 95% CI, 1.12-2.08) in Myeloma XI. The Myeloma XI trial protocol incorporated International Myeloma Working Group (IMWG) thrombosis prevention recommendations and compared with Myeloma IX, more patients received thromboprophylaxis (80.5% vs 22.3%) with lower rates of VTE for identical regimens (CTD, 13.2% vs 16.1%; CTDa, 10.7% vs 16.0%). However, thrombosis remained frequent in spite of IMWG-guided thromboprophylaxis, suggesting that new approaches are needed.",2020,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","['Patients with Myeloma Treated in the Myeloma IX and Myeloma XI', 'Newly diagnosed multiple myeloma (NDMM) patients treated with', 'Myeloma IX (n=1936) and Myeloma XI (n=4358), phase III randomized controlled trials for NDMM, treating transplant-eligible and ineligible patients before and after publication of thrombosis prevention guidelines']","['immunomodulatory drugs (IMiDs', 'CRD (cyclophosphamide, lenalidomide and dexamethasone', 'CVAD induction (cyclophosphamide, vincristine, doxorubicin and dexamethasone', 'MP (melphalan and prednisolone', 'CTD (cyclophosphamide, thalidomide and dexamethasone']","['Thrombosis', 'arterial risk', 'VTE rates', 'Thrombotic events', 'inferior progression-free or overall survival (OS', 'VTE or arterial thrombosis risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0082139', 'cui_str': 'CVAD protocol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}]","[{'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}]",,0.147899,"Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI.","[{'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Bradbury', 'Affiliation': 'School of Translational Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Craig', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hockaday', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Paterson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Jones', 'Affiliation': 'Kings College Hospital NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology, School of Immunity and Infection, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Roger G', 'Initials': 'RG', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Faith E', 'Initials': 'FE', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Health, New York, NY; and.'}, {'ForeName': 'J Anthony', 'Initials': 'JA', 'LastName': 'Child', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, New York University Langone Health, New York, NY; and.'}, {'ForeName': 'Graham H', 'Initials': 'GH', 'LastName': 'Jackson', 'Affiliation': 'Freeman Hospital, University of Newcastle, Newcastle Upon Tyne, United Kingdom.'}]",Blood,['10.1182/blood.2020005125']
1073,31411903,Randomized Trial of First-Line Behavioral Intervention to Reduce Need for Medication in Children with ADHD.,"A study conducted in an analogue summer treatment setting showed that when concurrently receiving behavioral intervention, many children with Attention-Deficit Hyperactivity Disorder (ADHD) did not need medication or maximized responsiveness at very low doses. The present study followed participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings. There were 127 unmedicated children with ADHD between the ages of 5 and 13 who were randomly assigned to receive or not receive behavioral consultation (BC) at the start of the school year. Children were evaluated by teachers and parents each week to determine if central nervous system stimulant treatment was needed. Children who received BC were approximately half as likely those who did not (NoBC) to initiate medication use each week at school or home and used lower doses when medicated at school. This produced a 40% reduction in total methylphenidate exposure over the course of the school year. BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive. Moreover, BC and NoBC groups did not significantly differ in cost of treatment; although children in the BC condition accrued additional costs via the BC, these costs were offset by the associated delay and reduction in medication use. Results add to a growing literature suggesting that the use of low-intensity behavioral intervention as a first-line treatment reduces or eliminates the need for medication in children with ADHD.",2019,"BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive.","['children with ADHD', 'participants in that summer study into the subsequent school year to investigate whether the same pattern would extend to the natural school and home settings', 'Children with ADHD', '127 unmedicated children with ADHD between the ages of 5 and 13 who were randomly assigned to', 'children with Attention-Deficit Hyperactivity Disorder (ADHD']","['behavioral intervention', 'receive or not receive behavioral consultation (BC', 'First-Line Behavioral Intervention']",['total methylphenidate exposure'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",127.0,0.0272917,"BC and NoBC groups did not significantly differ on end-of-year teacher or parent ratings of behavior, which were positive.","[{'ForeName': 'Erika K', 'Initials': 'EK', 'LastName': 'Coles', 'Affiliation': 'a Center for Children and Families, Florida International University.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham Iii', 'Affiliation': 'b Department of Psychology, Arizona State University.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fabiano', 'Affiliation': 'c Department of Counseling, School, and Educational Psychology, State University of New York at Buffalo.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Gnagy', 'Affiliation': 'a Center for Children and Families, Florida International University.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Burrows-MacLean', 'Affiliation': 'd Department of Psychology, State University of New York at Buffalo.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Wymbs', 'Affiliation': 'e Department of Psychology, Ohio University.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Chacko', 'Affiliation': 'f Department of Applied Psychology, New York University.'}, {'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'Walker', 'Affiliation': 'g The Hospital for Sick Children.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Wymbs', 'Affiliation': 'e Department of Psychology, Ohio University.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Robb Mazzant', 'Affiliation': 'a Center for Children and Families, Florida International University.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Garefino', 'Affiliation': 'h Department of Psychology, Kennesaw State University.'}, {'ForeName': 'Martin T', 'Initials': 'MT', 'LastName': 'Hoffman', 'Affiliation': 'j Department of Pediatrics, State University of New York at Buffalo.'}, {'ForeName': 'Greta M', 'Initials': 'GM', 'LastName': 'Massetti', 'Affiliation': 'd Department of Psychology, State University of New York at Buffalo.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Page', 'Affiliation': 'k Department of Health Policy and Management, Florida International University.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Waschbusch', 'Affiliation': 'i Department of Psychiatry, Pennsylvania State University Milton S. Hershey Medical Center.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'i Department of Psychiatry, Pennsylvania State University Milton S. Hershey Medical Center.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'a Center for Children and Families, Florida International University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1630835']
1074,31480979,Does testosterone impair men's cognitive empathy? Evidence from two large-scale randomized controlled trials.,"The capacity to infer others' mental states (known as 'mind reading' and 'cognitive empathy') is essential for social interactions across species, and its impairment characterizes psychopathological conditions such as autism spectrum disorder and schizophrenia. Previous studies reported that testosterone administration impaired cognitive empathy in healthy humans, and that a putative biomarker of prenatal testosterone exposure (finger digit ratios) moderated the effect. However, empirical support for the relationship has relied on small sample studies with mixed evidence. We investigate the reliability and generalizability of the relationship in two large-scale double-blind placebo-controlled experiments in young men (n = 243 and n = 400), using two different testosterone administration protocols. We find no evidence that cognitive empathy is impaired by testosterone administration or associated with digit ratios. With an unprecedented combined sample size, these results counter current theories and previous high-profile reports, and demonstrate that previous investigations of this topic have been statistically underpowered.",2019,"The capacity to infer others' mental states (known as 'mind reading' and 'cognitive empathy') is essential for social interactions across species, and its impairment characterizes psychopathological conditions such as autism spectrum disorder and schizophrenia.","['healthy humans', 'young men (n = 243 and n = 400']","['testosterone administration protocols', 'testosterone', 'placebo']",['cognitive empathy'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}]",400.0,0.329516,"The capacity to infer others' mental states (known as 'mind reading' and 'cognitive empathy') is essential for social interactions across species, and its impairment characterizes psychopathological conditions such as autism spectrum disorder and schizophrenia.","[{'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Nadler', 'Affiliation': 'BFI, Toronto, Ontario, Canada.'}, {'ForeName': 'Colin F', 'Initials': 'CF', 'LastName': 'Camerer', 'Affiliation': 'Department of the Humanities and Social Sciences, California Institute of Technology, 1200 E California Boulevard, MC 228-77, Pasadena, CA 91125, USA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Zava', 'Affiliation': 'ZRT Laboratory, 8605 SW Creekside Place, Beaverton, OR 97008, USA.'}, {'ForeName': 'Triana L', 'Initials': 'TL', 'LastName': 'Ortiz', 'Affiliation': 'Department of Psychology, Nipissing University, 100 College Drive, North Bay, Ontario, Canada P1B 8L7.'}, {'ForeName': 'Neil V', 'Initials': 'NV', 'LastName': 'Watson', 'Affiliation': 'Department of Psychology, Simon Fraser University, 8888 University Drive, Burnaby, British Columbia, Canada V5A 1S6.'}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Carré', 'Affiliation': 'Department of Psychology, Nipissing University, 100 College Drive, North Bay, Ontario, Canada P1B 8L7.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Nave', 'Affiliation': 'Marketing Department, The Wharton School of the University of Pennsylvania, 3730 Walnut Street, Philadelphia, PA 19104, USA.'}]",Proceedings. Biological sciences,['10.1098/rspb.2019.1062']
1075,31506478,A Prediction Model with Lifestyle in Addition to Previously Known Risk Factors Improves Its Predictive Ability for Cardiovascular Death.,"This longitudinal cohort study aimed to create a novel prediction model for cardiovascular death with lifestyle factors. Subjects aged 40-74 years in the Japanese nationwide Specific Health Checkup Database in 2008 were included. Subjects were randomly assigned to the derivation and validation cohorts by a 2:1 ratio. Points for the prediction model were determined using regression coefficients that were derived from the Cox proportional hazards model in the derivation cohort. Models 1 and 2 were developed using known risk factors and known factors with lifestyle factors, respectively. The models were validated by comparing Kaplan-Meier curves between the derivation and validation cohorts, and by calibration plots in the validation cohort. Among 295,297 subjects, data for 120,823 were available. There were 310 cardiovascular deaths during a mean follow-up of 3.6 years. Model 1 included known risk factors. In model 2, weight gain, exercise habit, gait speed, and drinking alcohol were additionally included as protective factors. Kaplan-Meier curves matched better between the derivation and validation cohorts in model 2, and model 2 was better calibrated. In conclusion, our prediction model with lifestyle factors improved the predictive ability for cardiovascular death.",2019,"Kaplan-Meier curves matched better between the derivation and validation cohorts in model 2, and model 2 was better calibrated.","['Subjects aged 40-74 years in the Japanese nationwide Specific Health Checkup Database in 2008 were included', '295,297 subjects, data for 120,823 were available']",[],"['weight gain, exercise habit, gait speed, and drinking alcohol', 'predictive ability for cardiovascular death', '310 cardiovascular deaths']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2008.0,0.0220599,"Kaplan-Meier curves matched better between the derivation and validation cohorts in model 2, and model 2 was better calibrated.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Tagawa', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Matsui', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Eriguchi', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Samejima', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Kunitoshi', 'Initials': 'K', 'LastName': 'Iseki', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Iseki', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Asahi', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamagata', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Konta', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Ichiei', 'Initials': 'I', 'LastName': 'Narita', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kasahara', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Yugo', 'Initials': 'Y', 'LastName': 'Shibagaki', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Steering Committee of Research on Design of the Comprehensive Health Care System for Chronic Kidney Disease (CKD) Based on the Individual Risk Assessment by Specific Health Check, Fukushima, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Tsuruya', 'Affiliation': 'Department of Nephrology, Nara Medical University, Nara, Japan. tsuruya@naramed-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-019-49003-5']
1076,31511557,One-year clinical evaluation of rotationally asymmetric multifocal intraocular lens with +1.5 diopters near addition.,"We conducted a one-year prospective, multicenter study to assess clinical outcomes after implantation of segmented, rotationally asymmetric multifocal intraocular lenses (IOLs) with +1.5 diopters (D) near addition. In this phase III clinical trial, 120 eyes of 65 patients undergoing phacoemulsification and implantation of Lentis Comfort LS-313 MF15 (Oculentis GmbH) were included. The ophthalmological examinations were performed before and 1 day, 1 week, 1, 3, 6, 9, and 12 months after surgery. Uncorrected (UDVA) and corrected (CDVA) distance visual acuity, uncorrected (UIVA) and distance-corrected (DCIVA) intermediate visual acuity at 70 cm, and uncorrected (UNVA) and distance-corrected (DCNVA) near visual acuity at 30 cm were measured. A defocus curve was obtained and patients were asked about the severity of photic phenomena. Postoperative distance and intermediate visual acuity was excellent, with UDVA, CDVA, UIVA, and DCIVA of approximately 20/20, 20/16, 20/25, 20/25 were attained, respectively. The level of near visual acuity was lower; UNVA and DCNVA remained at around 20/60 and 20/70, respectively. The defocus curve indicated that postoperative uncorrected visual acuity of 20/25 and 20/40 was obtained at as close as 67 cm and 50 cm, respectively. Contrast sensitivity was within the normal range, with a minimal level of subjective symptoms and high patient satisfaction. The rotationally asymmetric multifocal IOLs with +1.5 D near addition provided excellent distance and intermediate vision, but near vision was not enough for reading small prints. Contrast sensitivity was high, with very low incidences of photic phenomena and a high level of patient satisfaction.",2019,"The level of near visual acuity was lower; UNVA and DCNVA remained at around 20/60 and 20/70, respectively.",['120 eyes of 65 patients undergoing phacoemulsification and implantation of Lentis Comfort LS-313 MF15 (Oculentis GmbH)\xa0were included'],"['implantation of segmented, rotationally asymmetric multifocal intraocular lenses (IOLs) with +1.5 diopters (D) near addition']","['Uncorrected (UDVA) and corrected (CDVA', 'postoperative uncorrected visual acuity', 'Contrast sensitivity', 'Postoperative distance and intermediate visual acuity', 'level of near visual acuity', 'distance visual acuity, uncorrected (UIVA) and distance-corrected (DCIVA) intermediate visual acuity at 70\u2009cm, and uncorrected (UNVA) and distance-corrected (DCNVA) near visual acuity', 'UDVA, CDVA, UIVA, and DCIVA']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0493722', 'cui_str': 'Multifocal IOLs'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}]","[{'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}]",65.0,0.175873,"The level of near visual acuity was lower; UNVA and DCNVA remained at around 20/60 and 20/70, respectively.","[{'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Oshika', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan. oshika@eye.ac.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': ""Queen's Eye Clinic, Kanagawa, Japan.""}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Fujita Eye Clinic, Tokushima, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Inamura', 'Affiliation': 'Inamura Eye Clinic, Kanagawa, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Inoue Eye Clinic, Okayama, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Noda', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization, Tokyo Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Miyata Eye Hospital, Miyazaki, Japan.'}]",Scientific reports,['10.1038/s41598-019-49524-z']
1077,31511629,The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial.,"Surface electromyography-biofeedback (sEMG-B) is a technique employed for the rehabilitation of patients with neurological pathologies, such as stroke-derived hemiplegia; however, little is known about its effectiveness in the rehabilitation of the extension and flexion of several muscular groups in elderly patients after a stroke. Therefore, this research was focused on determining the effectiveness of sEMG-B in the muscles responsible for the extension of the hand and the dorsiflexion of the foot in post-stroke elderly subjects. Forty subjects with stroke-derived hemiplegia were randomly divided into intervention or control groups. The intervention consisted of 12 sEMG-B sessions. The control group underwent 12 weeks (24 sessions) of conventional physiotherapy. Muscle activity test and functionality (Barthel index) were determined. Attending to the results obtained, the intervention group showed a higher increase in the average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot than the control group (p < 0.001 in both cases), which was associated with an increase in the patients' Barthel index score (p = 0.006); In addition, Fugl-Meyer test revealed higher effectiveness in the lower limb (p = 0.007). Thus, the sEMG-B seems to be more effective than conventional physiotherapy, and the use of this technology may be essential for improving muscular disorders in elderly patients with physical disabilities resulting from a stroke.",2019,"Attending to the results obtained, the intervention group showed a higher increase in the average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot than the control group (p < 0.001 in both cases), which was associated with an increase in the patients' Barthel index score (p = 0.006); In addition, Fugl-Meyer test revealed higher effectiveness in the lower limb (p = 0.007).","['elderly adults', 'patients with neurological pathologies', 'Forty subjects with stroke-derived hemiplegia', 'post-stroke elderly subjects', 'elderly patients after a stroke', 'elderly patients with physical disabilities resulting from a stroke']","['surface electromyography biofeedback', 'Surface electromyography-biofeedback (sEMG-B', 'conventional physiotherapy']","['average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot', ""patients' Barthel index score"", 'activity of extensor and dorsiflexor muscles', 'Muscle activity test and functionality (Barthel index']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",40.0,0.0233435,"Attending to the results obtained, the intervention group showed a higher increase in the average EMG activity of the extensor muscle of the hand and in the dorsal flexion of the foot than the control group (p < 0.001 in both cases), which was associated with an increase in the patients' Barthel index score (p = 0.006); In addition, Fugl-Meyer test revealed higher effectiveness in the lower limb (p = 0.007).","[{'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Gámez', 'Affiliation': 'Physiotherapy Service, ""Sagrado Corazón"" Hospital, Malaga, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Hernandez Morante', 'Affiliation': 'Faculty of Health and Life Sciences, Catholic University of Murcia, Murcia, Spain. jjhernandez@ucam.edu.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Martínez Gil', 'Affiliation': 'Physiotherapy Service, Arrixaca Hospital, Murcia, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Esparza', 'Affiliation': 'International Chair of Cineanthropometry, Catholic University of Murcia, Murcia, Spain.'}, {'ForeName': 'Carlos Manuel', 'Initials': 'CM', 'LastName': 'Martínez', 'Affiliation': 'IMIB - Experimental Pathology Service, Arrixaca Hospital, Murcia, Spain.'}]",Scientific reports,['10.1038/s41598-019-49720-x']
1078,32506325,Postoperative online follow-up improves the quality of life of patients who undergo extraction of impacted madibular third molars: a randomized controlled trial.,"OBJECTIVE


To evaluate the effect of online follow-up on the quality of life of patients who undergo extraction of impacted mandibular third molars.
MATERIALS AND METHODS


This study enrolled patients with impacted mandibular third molars who were treated at the Department of Oral and Maxillofacial Surgery of the Stomatological Hospital at Southern Medical University and divided them into test and control groups. The test group received an online follow-up on the first, third, and fifth days after tooth extraction, while the control group was not followed up with. Patients in both groups were reexamined on the postoperative seventh day, completing the postoperative symptom severity (PoSSe) scale to comprehensively and quantitatively evaluate their quality of life after tooth extraction. A visual analogue scale (VAS) was used to evaluate the degree of approval for an online follow-up after tooth extraction by 20 senior doctors (≥ 40 years old) and 20 young doctors (<4 0 years old).
RESULTS


The PoSSe scale scores of the remaining options in the test group were significantly lower than those in the control group. The VAS score of senior doctors for online follow-up was significantly lower than that of young doctors.
CONCLUSIONS


A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars. Compared with senior doctors, young doctors were more likely to approve an online follow-up after tooth extraction.
CLINICAL RELEVANCE


Online medical care can be considered as an auxiliary tool to improve the effect of oral treatment.",2020,A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars.,"['patients who undergo extraction of impacted mandibular third molars', 'patients who undergo extraction of impacted madibular third molars', 'enrolled patients with impacted mandibular third molars who were treated at the Department of Oral and Maxillofacial Surgery of the Stomatological Hospital at Southern Medical University and divided them into test and control groups', '20 senior doctors (≥ 40 years old) and 20 young doctors (<4 0 years old', 'patients who underwent extraction of impacted mandibular third molars']",[],"['quality of life', 'visual analogue scale (VAS', 'PoSSe scale scores', 'postoperative symptom severity (PoSSe) scale', 'VAS score of senior doctors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0438377,A postoperative online follow-up effectively improved the quality of life of patients who underwent extraction of impacted mandibular third molars.,"[{'ForeName': 'Xianghuai', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jia', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhaoqiang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Jinyuan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': ""Department of Oral and Maxillofacial Surgery, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Center of Oral Implantology, Stomatological Hospital, Southern Medical University (Guangdong Provincial Stomatological Hospital), No. 366, South of Jiangnan Road, Guangzhou, 510280, Guangdong, People's Republic of China. 654365980@qq.com.""}]",Clinical oral investigations,['10.1007/s00784-020-03388-0']
1079,32246478,Results of the prematurely terminated TEMPLE randomized controlled trial in patients with myelodysplastic syndrome: liberal versus restrictive red blood cell transfusion threshold.,,2020,,['patients with myelodysplastic syndrome'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}]",[],[],,0.0599636,,"[{'ForeName': 'A J G', 'Initials': 'AJG', 'LastName': 'Jansen', 'Affiliation': 'Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'van den Bosch', 'Affiliation': 'Department of Oncology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Peter A W', 'Initials': 'PAW', 'LastName': 'Te Boekhorst', 'Affiliation': 'Department of Hematology, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Schipperus', 'Affiliation': 'Department of Hematology, Leyenburg Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Erik A M', 'Initials': 'EAM', 'LastName': 'Beckers', 'Affiliation': 'Sanquin Blood Bank South West Region, Rotterdam, The Netherlands.'}]",Transfusion,['10.1111/trf.15708']
1080,32499466,The efficacy of two doses versus 7 days' course of prophylactic antibiotics following cesarean section: An experience from Aminu Kano Teaching Hospital.,"Background


Postcesarean wound infection is a leading cause of prolonged hospital stay. Considerable debates still exist regarding choice of antibiotics, dose, and duration of use.
Objectives


The objective is to compare the efficacy of 2 doses of amoxicillin-clavulanic acid versus a 7 days combination of amoxicillin-clavulanic acid and metronidazole as prophylactic antibiotics following cesarean section (CS).
Methodology


It was a randomized controlled trial that was conducted among 160 women undergoing CS at Aminu Kano Teaching Hospital. Women were randomized into two groups. Group I (study group) received 2 doses of 1.2 g amoxicillin-clavulanic acid. Group II (control group) received a 7 days course of amoxicillin-clavulanic acid and metronidazole. The data obtained were analyzed using SPSS version 17. Categorical (qualitative) variables were analyzed using Chi-square test and Fisher's exact test as appropriate while continuous (quantitative) variables were analyzed using independent sample t-test. P < 0.05 was considered statistically significant.
Results


There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups. There was statistically significant difference in the mean cost of antibiotics (₦2883/US$9.5 vs. ₦7040/US$23.1, P < 0.001) and maternal side effects (10.3% vs. 26.3%, P < 0.001) between the study and the control groups, respectively.
Conclusion


This study found no statistically significant difference in infectious morbidity, duration of hospital stay, and neonatal outcomes when two doses of amoxicillin-clavulanic acid was compared with a 7 days course of prophylactic antibiotic following CS. The use of two doses of amoxicillin-clavulanic acid has the advantages of reduced cost and some maternal side effects. The two doses were cheaper with minimal side effects.",2020,"There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups.","['160 women undergoing CS at Aminu Kano Teaching Hospital', 'cesarean section']","['prophylactic antibiotics', 'amoxicillin-clavulanic acid', 'amoxicillin-clavulanic acid and metronidazole']","['mean duration of hospital stay', 'occurrence of fever', 'mean cost of antibiotics', 'wound infection', 'infectious morbidity, duration of hospital stay, and neonatal outcomes', 'endometritis', 'maternal side effects', 'neonatal outcomes']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",160.0,0.0917406,"There was no statistically significant association in the occurrence of fever (12.8% vs. 15.8%, P = 0.6), wound infection (6.4% vs. 10.5%, P = 0.36), endometritis (7.7% vs. 11.8%, P = 0.38), UTI (6.4% vs. 5.3%, P = 1.00), mean duration of hospital stay (129.7 vs. 134.2 h, P = 0.48), and neonatal outcomes between the two groups.","[{'ForeName': 'Salihu Ozegya', 'Initials': 'SO', 'LastName': 'Mohammed', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Samaila Danjuma', 'Initials': 'SD', 'LastName': 'A Shuaibu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Sule Abdullahi', 'Initials': 'SA', 'LastName': 'Gaya', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}, {'ForeName': 'Ayyuba', 'Initials': 'A', 'LastName': 'Rabiu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Bayero University Kano/Aminu Kano Teaching Hospital, Kano, Nigeria.'}]",Annals of African medicine,['10.4103/aam.aam_39_19']
1081,32504314,Analysis of C. difficile infection-related outcomes in European participants in the bezlotoxumab MODIFY I and II trials.,"The MODIFY I/II trials demonstrated that bezlotoxumab, a human monoclonal antibody against Clostridioides difficile toxin B, given during antibiotic treatment for Clostridioides difficile infection (CDI) significantly reduced C. difficile recurrence (rCDI) in adults at high risk for rCDI. Efficacy of CDI-directed intervention may depend on ribotype regional epidemiology, and patient characteristics. This post hoc analysis assessed the efficacy of bezlotoxumab in the subgroup of MODIFY I/II trial participants enrolled in Europe. Data from the bezlotoxumab (10 mg/kg single intravenous infusion) and placebo (0.9% saline) groups from MODIFY I/II were compared to assess initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality through 12 weeks post-infusion. Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48%). Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%). Fifty-five percent of participants were female, and 86% were hospitalized at randomization. The rate of ICC was similar between treatment groups. The rate of rCDI in the bezlotoxumab group was lower compared with placebo among European participants overall, and among those with ≥ 1 risk factor for rCDI. Bezlotoxumab reduced 30-day CDI-associated rehospitalizations compared with placebo. These results are consistent with overall results from the MODIFY trials and demonstrate that bezlotoxumab reduces rCDI and CDI-associated rehospitalizations in European patients with CDI. MODIFY I/II (NCT01241552 and NCT01513239).",2020,"Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%).","['Fifty-five percent of participants were female, and 86% were hospitalized at randomization', 'adults at high risk for rCDI', 'Of 1554 worldwide participants, 606 were from Europe (bezlotoxumab n = 313, 51%; placebo n = 292; 48', 'European participants in the bezlotoxumab MODIFY I and II trials', 'European patients with CDI', 'subgroup of MODIFY I/II trial participants enrolled in Europe']","['bezlotoxumab', 'CDI-directed intervention', 'Bezlotoxumab', 'placebo']","['initial clinical cure (ICC), rCDI, all-cause, and CDI-associated rehospitalizations within 30 days of discharge, and mortality', 'rate of rCDI', 'rate of ICC', '30-day CDI-associated rehospitalizations']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}]","[{'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0343386', 'cui_str': 'Clostridioides difficile infection'}]",1554.0,0.572207,"Baseline characteristics were generally similar across groups, although there were more immunocompromised participants in the bezlotoxumab group (27.2%) compared with placebo (20.1%).","[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Bouza', 'Affiliation': 'University Complutense of Madrid, Madrid, Spain.'}, {'ForeName': 'Oliver A', 'Initials': 'OA', 'LastName': 'Cornely', 'Affiliation': 'Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM); Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD); Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ramos-Martinez', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plesniak', 'Affiliation': 'University of Rzeszów Medical Center, Łańcut, Poland.'}, {'ForeName': 'Misoo C', 'Initials': 'MC', 'LastName': 'Ellison', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Hanson', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. mary.beth.dorr@merck.com.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-03935-3']
1082,32493780,Accuracy of Xpert Ultra in Diagnosis of Pulmonary Tuberculosis among Children in Uganda: a Substudy from the SHINE Trial.,"Childhood tuberculosis (TB) presents significant diagnostic challenges associated with paucibacillary disease and requires a more sensitive test. We evaluated the diagnostic accuracy of Xpert MTB/RIF Ultra (Ultra) compared to other microbiological tests using respiratory samples from Ugandan children in the SHINE trial. SHINE is a randomized trial evaluating shorter treatment in 1,204 children with minimal TB disease in Africa and India. Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with the Xpert MTB/RIF assay (Xpert) and with Lowenstein-Jensen medium (LJ) and liquid mycobacterial growth indicator tube (MGIT) cultures. We selected only uncontaminated stored sample pellets for Ultra testing. We estimated the sensitivity of Xpert and Ultra against culture and a composite microbiological reference standard (any positive result). Of 398 children, 353 (89%) had culture, Xpert, and Ultra results. The median age was 2.8 years (interquartile range [IQR], 1.3 to 5.3); 8.5% (30/353) were HIV infected, and 54.4% (192/353) were male. Of the 353, 31 (9%) were positive by LJ and/or MGIT culture, 36 (10%) by Ultra, and 16 (5%) by Xpert. Sensitivities (95% confidence intervals [CI]) were 58% (39 to 65% [18/31]) for Ultra and 45% (27 to 64% [14/31]) for Xpert against any culture-positive result, with false positives of <1% and 5.5% for Xpert and Ultra. Against a composite microbiological reference, sensitivities were 72% (58 to 84% [36/50]) for Ultra and 32% (20 to 47% [16/50]) for Xpert. However, there were 17 samples that were positive only with Ultra (majority trace). Among children screened for minimal TB in Uganda, Ultra has higher sensitivity than Xpert. This represents an important advance for a condition which has posed a diagnostic challenge for decades.",2020,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","['Ugandan children in the SHINE trial', '1204 children with minimal TB disease in Africa/India', '398 children, 353 (89%) had culture, Xpert and Ultra results', 'Among 352 samples and one cervical lymph node fine needle aspirate, one sample was randomly selected per patient and tested with', 'Median age was 2.8-years (IQR 1.3-5.3); 8.5% (30/353) HIV-infected, 54.4% (192/353) male', 'pulmonary tuberculosis among children in Uganda']","['Xpert MTB/Rif (Xpert), Lowenstein Jensen (LJ) and liquid (MGIT) cultures', 'XpertMTB/Rif Ultra (Ultra', 'Xpert Ultra']",['Sensitivities'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C1280568', 'cui_str': 'Specimen obtained by fine needle aspiration procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",1204.0,0.137987,"Sensitivities were (%; 95% CI), 58% (39-65% (18/31)) for Ultra and 45% (27-64% (14/31)) for Xpert against any culture-positive, with false-positives of <1% and 5.5% for Xpert and Ultra.","[{'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Ssengooba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda Willyssengooba@gmail.com.'}, {'ForeName': 'Jean de Dieu', 'Initials': 'JD', 'LastName': 'Iragena', 'Affiliation': 'Communicable Diseases Cluster, HIV/TB and Hepatitis Programme, World Health Organization Regional Office for Africa, Brazzaville, Congo.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Nakiyingi', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Serestine', 'Initials': 'S', 'LastName': 'Mujumbi', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wobudeya', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Mboizi', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boulware', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Meya', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences Makerere University, Kampala, Uganda.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Choo', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lebeau', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Joloba', 'Affiliation': 'Makerere University, Department of Medical Microbiology, Mycobacteriology (BSL-3) Laboratory, Kampala, Uganda.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Demers', 'Affiliation': 'Desmond Tutu Tuberculosis Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Fiona V', 'Initials': 'FV', 'LastName': 'Cresswell', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, United Kingdom.'}]",Journal of clinical microbiology,['10.1128/JCM.00410-20']
1083,32268000,A Single and Multiple Ascending Dose Study of Toll-Like Receptor 7 Agonist (RO7020531) in Chinese Healthy Volunteers.,"Toll-like receptor 7 (TLR7) agonists modulate broad spectrum immune activity and are evaluated in the treatment of human diseases, including cancer and chronic viral infection. RO7020531, an oral prodrug of a TLR7 agonist, is in clinical development as part of a curative regimen against chronic hepatitis B. We report the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of RO7020531 in healthy Chinese volunteers following single and multiple ascending doses (SAD and MAD). PK and PD samples were evaluated from four SAD cohorts and 3 MAD cohorts with 10 subjects each (8 active and 2 placebo). Safety and tolerability were monitored throughout the study. A total of 155 adverse events (AEs) were reported in 49 subjects. Fifty-one AEs in 18 subjects were assessed as treatment-related. Most of the AEs were mild; nine subjects experienced moderate AEs; there were no severe AEs. In two 150 mg MAD cohorts given every other day (q.o.d.), 7 of 20 subjects experienced pyrexia and were discontinued due to transient asymptomatic lymphopenia, which resolved 24-48 hours postdose. The PK of the active metabolite, RO7011785, increased linearly with dose from 40 mg to 170 mg. There was no PK accumulation following q.o.d. dosing. The PK profile is consistent with observations in white subjects in the global first-in-human study. SADs and MADs of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100 mg or above. Flu-like symptoms were associated with higher interferon-α levels. RO7020531 was safe and acceptably tolerated in healthy Chinese volunteers with a multiple 150 mg q.o.d. dose regimen.",2020,Single and multiple doses of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100mg or above.,"['Chinese healthy volunteers', 'Chinese healthy volunteers following single and multiple ascending doses (SAD & MAD', 'Chinese Healthy Volunteers']","['Toll', 'Like Receptor 7 (TLR 7) Agonist (RO7020531', 'RO7020531', 'TLR7 agonist', 'TLR7']","['TLR7 response markers', 'Safety and tolerability', 'safe and acceptably tolerated', 'PK accumulation', 'safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}]","[{'cui': 'C0971207', 'cui_str': 'TLR7 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",18.0,0.0606734,Single and multiple doses of RO7020531 resulted in dose-dependent increases in TLR7 response markers at 100mg or above.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Luk', 'Affiliation': 'Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Qiudi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Glavini', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Triyatni', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Roche Pharma Development Shanghai, Shanghai, China.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Racek', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Roche Innovation Center Shanghai, Shanghai, China.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Grippo', 'Affiliation': 'Roche Innovation Center New York, New York, New York, USA.'}]",Clinical and translational science,['10.1111/cts.12791']
1084,26474943,Telmisartan and Insulin Resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy.,"INTRODUCTION


Telmisartan, an angiotensin receptor blocker, has beneficial effects on insulin resistance and cardiovascular health in non-HIV populations. This trial will evaluate whether telmisartan can reduce insulin resistance in HIV-positive individuals on combination antiretroviral therapy.
METHODS AND ANALYSIS


This is a phase II, multicentre, randomised, open-labelled, dose-ranging trial of telmisartan in 336 HIV-positive individuals over a period of 48 weeks. The trial will use an adaptive design to inform the optimal dose of telmisartan. Patients will be randomised initially 1:1:1:1 to receive one of the three doses of telmisartan (20, 40 and 80 mg) or no intervention (control). An interim analysis will be performed when half of the planned maximum of 336 patients have been followed up for at least 24 weeks. The second stage of the study will depend on the results of interim analysis. The primary outcome measure is a reduction in insulin resistance (as measured by Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)) in telmisartan treated arm(s) after 24 weeks of treatment in comparison with the non-intervention arm. The secondary outcome measures include changes in lipid profile; body fat redistribution (as measured by MRI); plasma and urinary levels of various biomarkers of cardiometabolic and renal health at 12, 24 and 48 weeks. Serious adverse events will be compared between different telmisartan treated dose arm(s) and the control arm.
ETHICS AND DISSEMINATION


The study, this protocol and related documents have been approved by the National Research Ethics Service Committee North West-Liverpool Central (Ref: 12/NW/0214). On successful completion, study data will be shared with academic collaborators. The findings from TAILoR will be disseminated through peer-reviewed publications, at scientific conferences, the media and through patient and public involvement.
TRIAL REGISTRATION NUMBERS


04196/0024/001-0001;
EUDRACT


2012-000935-18;
ISRCTN


51069819.",2015,"INTRODUCTION


Telmisartan, an angiotensin receptor blocker, has beneficial effects on insulin resistance and cardiovascular health in non-HIV populations.","['HIV (TAILoR', '336 patients have been followed up for at least 24\u2005weeks', '336 HIV-positive individuals over a period of 48\u2005weeks', 'HIV-positive individuals on combination antiretroviral therapy']","['Telmisartan', 'telmisartan (20, 40 and 80\u2005mg) or no intervention (control', 'telmisartan']","['changes in lipid profile; body fat redistribution (as measured by MRI); plasma and urinary levels of various biomarkers of cardiometabolic and renal health', 'reduction in insulin resistance (as measured by Homeostatic Model Assessment-Insulin Resistance (HOMA-IR', 'insulin resistance']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0332620', 'cui_str': 'Redistribution (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.370795,"INTRODUCTION


Telmisartan, an angiotensin receptor blocker, has beneficial effects on insulin resistance and cardiovascular health in non-HIV populations.","[{'ForeName': 'Sudeep P', 'Initials': 'SP', 'LastName': 'Pushpakom', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, The Wolfson Centre for Personalised Medicine, University of Liverpool, Liverpool, UK MRC Centre for Drug Safety Science, University of Liverpool, Liverpool, UK Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Spowart', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jiten', 'Initials': 'J', 'LastName': 'Vora', 'Affiliation': 'Department of Diabetes and Endocrinology, The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'Kemp', 'Affiliation': 'Magnetic Resonance and Image Analysis Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Whitehead', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Williamson', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK Department of Biostatistics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Pirmohamed', 'Affiliation': 'Department of Molecular and Clinical Pharmacology, The Wolfson Centre for Personalised Medicine, University of Liverpool, Liverpool, UK MRC Centre for Drug Safety Science, University of Liverpool, Liverpool, UK Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}]",BMJ open,['10.1136/bmjopen-2015-009566']
1085,32504862,Comparative Study of Mizoribine and Mycophenolate Mofetil Combined with a Calcineurin Inhibitor-Based Immunosuppressive Regimen in Patients with Alternative Donor Hematopoietic Cell Transplantation.,"Cytomegalovirus (CMV) infection and graft-versus-host disease (GVHD) remain the major causes of nonrelapse mortality (NRM) in patients following alternative donor hematopoietic stem cell transplantation (HCT). Mizoribine (MZR) showed an anti-CMV effect in addition to its immunosuppressive effect in patients with renal transplantation. In this study, we aimed to evaluate the efficacy and safety of MZR combined with a calcineurin inhibitor (CNI) as a method of prophylactic immunosuppression in recipients following alternative donor HCT. Eighty patients were enrolled in the study and randomized to the MZR (n = 40) or MMF (n = 40) cohort before transplantation conditioning. Analyses involved a comparison of the outcomes between the 2 cohorts, as well as risk analyses of early nonrelapse mortality (NRM) and severe CMV infection. In contrast to MMF, MZR was associated with a lower but statistically nonsignificant median CMV DNA peak load (P = .075), significantly fewer episodes of persistent/refractory infection (odds ratio [OR], .12), and a lower failure rate of CMV treatment (OR, .82), but a significantly higher rate of hyperuricemia (OR, 2.75). Transplantation efficacy was comparable in the 2 cohorts regarding engraftment, the development of secondary poor graft function and GVHD, and the estimated OS and PFS. The 1-year NRM of the MZR cohort did not differ from that of the MMF cohort, whereas the rate of 1-year NRM caused by viral infections was reduced in the MZR cohort and was of borderline statistical significance (P = .05). In the multivariate analysis, lower doses of CD34 +  cells in grafts (hazard ratio [HR], 3.65) and persistent/refractory CMV infections (versus no CMV infection: HR, 7.31; versus CMV infection that was not persistent/refractory: HR, 4.46) were predictors of increased 1-year NRM. The use of MMF (versus MZR cohort: OR, 11.54) and grade II-IV acute GVHD (OR, 15.32) were independent risk factors for developing persistent/refractory CMV infection. When combined with CNIs, MZR functioned well in terms of both immunosuppression and reduced severity of CMV infection; however, further studies are warranted to verify its use as a potential immunosuppressant for alternative donor HCT.",2020,"The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS.","['patients with renal transplantation', 'recipients following alternative donor HCT', 'patients following alternative donor HCT', 'for hematopoietic cell transplantation', 'patients with alternative donor hematopoietic cell transplantation', 'Eighty patients were enrolled in the study and randomized to the MZR (n\u202f=\u202f40) and MMF (n\u202f=\u202f40) cohorts before transplant conditioning']","['mizoribine and mycophenolate mofetil combined with a calcineurin inhibitor-based immunosuppressive regimen', 'Mizoribine vs mycophenolate mofetil', 'Mizoribine (MZR', 'MMF', 'MZR combined with CNIs']","['risk analyses of early NRM and severe CMV infection', 'episodes of persistent/refractory infection', 'median CMV DNA peak load', 'failure rate of CMV treatment', 'transplant efficacy', 'refractory CMV infections', 'rate of 1-y NRM caused by viral infections', 'efficacy and safety', 'occurrence of hyperuricemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0376450', 'cui_str': 'Conditioning, Transplantation'}]","[{'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0369083', 'cui_str': 'Cytomegalovirus DNA'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]",80.0,0.0245141,"The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Mingzhe', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Pang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhai', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Erlie', 'Initials': 'E', 'LastName': 'Jiang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Sizhou', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China. Electronic address: zhangli@ihcams.ac.cn.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.022']
1086,32507538,Vitamin D Supplementation Improves Health-Related Quality of Life and Physical Performance in Children with Sickle Cell Disease and in Healthy Children.,"INTRODUCTION


No study determined if vitamin D supplementation improves health-related quality of life (HRQL) using pediatric Patient-Reported Outcomes Measurement Information System or physical functioning in type SS sickle cell disease (HbSS).
METHOD


Subjects with HbSS (n = 21) and healthy subjects (n = 23) were randomized to daily oral doses (4,000 vs. 7,000 IU) of cholecalciferol (vitamin D 3 ) and evaluated at 6 and 12 weeks for changes in serum 25 hydroxyvitamin D (25(OH)D), HRQL, and physical functioning.
RESULTS


In subjects with HbSS, significant reductions in pain, fatigue, and depressive symptoms and improved upper-extremity function were observed. In healthy subjects, significant reductions in fatigue and improved upper-extremity function were observed. Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups. In subjects with HbSS, improved plantar flexion isometric maximal voluntary contraction torques were observed. Both groups saw significant improvement in their total Bruininks-Oseretsky Test of Motor Proficiency score.
DISCUSSION


Daily high-dose vitamin D supplementation for African American children with and without HbSS improved HRQL and physical performance.",2020,Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups.,"['African American children', 'type SS sickle cell disease (HbSS', 'Subjects with HbSS (n\u202f=\u202f21) and healthy subjects (n\u202f=\u202f23', 'Children with Sickle Cell Disease and in Healthy Children']","['Vitamin D Supplementation', 'cholecalciferol (vitamin D 3 ) and evaluated at 6 and 12 weeks for changes in serum 25 hydroxyvitamin D (25(OH)D), HRQL, and physical functioning', 'vitamin D supplementation']","['Health-Related Quality of Life and Physical Performance', 'health-related quality of life (HRQL', 'pain, fatigue, and depressive symptoms and improved upper-extremity function', 'HRQL and physical performance', 'total Bruininks-Oseretsky Test of Motor Proficiency score', 'peak power and dorsiflexion isometric maximal voluntary contraction torques', 'fatigue and improved upper-extremity function', 'plantar flexion isometric maximal voluntary contraction torques']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion'}]",23.0,0.0773497,Significant improvements in peak power and dorsiflexion isometric maximal voluntary contraction torques were observed in both groups.,"[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Dougherty', 'Affiliation': ''}, {'ForeName': 'Joan I', 'Initials': 'JI', 'LastName': 'Schall', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bertolaso', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Smith-Whitley', 'Affiliation': ''}, {'ForeName': 'Virginia A', 'Initials': 'VA', 'LastName': 'Stallings', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.04.007']
1087,31410765,Effect of Lozenges Containing Lactobacillus reuteri on the Severity of Recurrent Aphthous Ulcers: a Pilot Study.,"To investigate the effect of a probiotic supplement on the severity of aphthous lesions in patients with recurrent aphthous stomatitis (RAS) over a 3-month period. A second endpoint was to study the effect on pain related to the lesions. The study employed a double-blind randomized, placebo-controlled design with two parallel arms. Twenty patients with minor and major RAS were consecutively enrolled and randomly assigned to the test or the control group. The intervention consisted of lozenges containing two strains of Lactobacillus reuteri taken twice daily for 90 days. Ulcer Severity Score (USS) consisting of six lesion characteristics (number, size, duration, ulcer-free period, site, and pain) was calculated at baseline and after the intervention. Oral pain related to the lesions was estimated by the patients with a Visual Analogue Pain Scale. An improvement of the USS, as well as oral pain, was evident in both groups after 90 days but the reduction was only statistically significant (p < 0.05) compared with baseline in the test group. There were no significant differences between the groups, neither at baseline nor at follow-up. No side effects were recorded. Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo. The results encourage further research and provide a basis for power calculations of larger and extended studies. ClinicalTrials.gov Identifier: NCT02976922.",2020,Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo.,"['patients with recurrent aphthous stomatitis (RAS', 'Twenty patients with minor and major RAS']","['lozenges containing two strains of Lactobacillus reuteri', 'placebo', 'probiotic supplement', 'Lozenges Containing Lactobacillus reuteri']","['Oral pain', 'severity of aphthous lesions', 'pain', 'oral pain', 'Severity of Recurrent Aphthous Ulcers', 'Ulcer Severity Score (USS) consisting of six lesion characteristics (number, size, duration, ulcer-free period, site, and pain', 'Visual Analogue Pain Scale', 'side effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2937365', 'cui_str': 'Recurrent aphthous ulcer (disorder)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C4319836', 'cui_str': 'Lozenge'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0221776', 'cui_str': 'Painful mouth (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2937365', 'cui_str': 'Recurrent aphthous ulcer (disorder)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0042815', 'cui_str': 'Visual Analog Pain Scale'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0855241,Daily supplements with L. reuteri reduced the severity of aphthous lesions over a 90-day period but the improvement was not significantly better than placebo.,"[{'ForeName': 'Anne Marie Lynge', 'Initials': 'AML', 'LastName': 'Pedersen', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark. amlp@sund.ku.dk.'}, {'ForeName': 'Kathrine Hansen', 'Initials': 'KH', 'LastName': 'Bukkehave', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'Eric Paul', 'Initials': 'EP', 'LastName': 'Bennett', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark.'}, {'ForeName': 'Svante', 'Initials': 'S', 'LastName': 'Twetman', 'Affiliation': 'Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Nørre Allé 20, 2200, Copenhagen N, Denmark.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-019-09586-x']
1088,32493715,"Starch Digestion-Related Amylase Genetic Variants, Diet, and Changes in Adiposity: Analyses in Prospective Cohort Studies and a Randomized Dietary Intervention.","Salivary amylase, encoded by the  AMY1  gene, is responsible for the digestion of carbohydrates. We investigated associations of  AMY1  genetic variations with general and central adiposity changes considering dietary carbohydrate intake among 32,054 adults from four prospective cohort studies. A genetic risk score (GRS) was calculated based on nine  AMY1  single-nucleotide polymorphisms, with higher AMY1-GRS indicating higher activity of salivary amylase. We meta-analyzed interactions between AMY1-GRS and dietary intake for changes in general and central adiposity over 5.5-10 years. We found that carbohydrate food intake significantly altered associations of AMY1-GRS with changes in BMI ( P   interaction  = 0.001) and waist circumference ( P   interaction  < 0.001). Results were consistent and significant in female cohorts rather than in male cohorts. Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low. Also, in a 2-year randomized dietary intervention trial, associations of AMY1-GRS with changes in weight ( P   interaction  = 0.023) and waist circumference ( P   interaction  = 0.037) were significantly modified by carbohydrate intake. Our results suggest the importance of precision nutrition strategies considering participants' genetic adaptation to carbohydrate-rich diets in regulating general and central adiposity.",2020,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.",['32054 adults from 4 prospective cohort studies'],[],"['genetic risk score (GRS', 'waist circumference', 'adiposity if dietary carbohydrate food intake', 'body mass index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",32054.0,0.0265795,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.","[{'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu luqi@hsph.harvard.edu.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu luqi@hsph.harvard.edu.'}]",Diabetes,['10.2337/db19-1257']
1089,32503946,Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma.,"BACKGROUND


We have previously reported significantly longer overall survival (OS) with ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with advanced melanoma, with higher incidences of adverse events (AEs) at 10 mg/kg. This follow-up analysis reports a 5-year update of OS and safety.
METHODS


This randomized, multicenter, double-blind, phase III trial included patients with untreated or previously treated unresectable stage III or IV melanoma. Patients were randomly assigned (1:1) to ipilimumab 10 mg/kg or 3 mg/kg every 3 weeks for 4 doses. The primary end point was OS.
RESULTS


At a minimum follow-up of 61 months, median OS was 15.7 months (95% CI 11.6 to 17.8) at 10 mg/kg and 11.5 months (95% CI 9.9 to 13.3) at 3 mg/kg (HR 0.84, 95% CI 0.71 to 0.99; p=0.04). In a subgroup analysis, median OS of patients with asymptomatic brain metastasis was 7.0 months (95% CI 4.0 to 12.8) in the 10 mg/kg group and 5.7 months (95% CI 4.2 to 7.0) in the 3 mg/kg group. In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively. The incidence of grade 3/4 treatment-related AEs was 36% in the 10 mg/kg group vs 20% in the 3 mg/kg group, and deaths due to treatment-related AEs occurred in four (1%) and two patients (1%), respectively.
CONCLUSIONS


This 61-month follow-up of a phase III trial showed sustained long-term survival in patients with advanced melanoma who started metastatic treatment with ipilimumab monotherapy, and confirmed the significant benefit for those who received ipilimumab 10 mg/kg vs 3 mg/kg. These results suggest the emergence of a plateau in the OS curve, consistent with previous ipilimumab studies.
TRIAL REGISTRATION NUMBER


NCT01515189.",2020,"In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","['patients with advanced melanoma', 'patients with untreated or previously treated unresectable stage III or IV melanoma', 'patients with advanced melanoma who started metastatic treatment with']","['ipilimumab monotherapy', 'ipilimumab']","['OS', 'median OS', 'Overall survival', 'sustained long-term survival', 'median OS of patients with asymptomatic brain metastasis', 'overall survival (OS', 'incidence of grade 3/4 treatment-related AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.585321,"In patients with wild-type or mutant  BRAF  tumors, median OS was 13.8 months (95% CI 10.2 to 17.0) and 33.2 months (95% CI 19.4 to 45.2) in the 10 mg/kg group, and 11.2 months (95% CI 9.2 to 13.8) and 19.7 months (95% CI 11.6 to 25.3) in the 3 mg/kg group, respectively.","[{'ForeName': 'Paolo Antonio', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy paolo.ascierto@gmail.com.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Del Vecchio', 'Affiliation': 'Unit of Melanoma Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mackiewicz', 'Affiliation': 'Department of Diagnostics and Cancer Immunology, Greater Poland Cancer Center, Poznan Medical University, Poznan, Poland.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Department of Medicine, Dermatology Service, Gustave Roussy, Villejuif and Paris-Sud-University, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Melanoma Oncology Unit, Istituto Oncologico Veneto-IRCCS, Padova, Italy.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': ""Hospital Clinic and Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'Université de Paris, INSERM, Dermatology and CIC, Saint Louis Hospital, Paris, France.'}, {'ForeName': 'Inge Marie', 'Initials': 'IM', 'LastName': 'Svane', 'Affiliation': 'Center for Cancer Immune Therapy, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska-Curie Institute-Oncology Center, Warsaw, Poland.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': ""Clinique de Dermatologie, Unité d'Onco-Dermatologie, INSERM U1189, Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez, Lille, France.""}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Melanoma Center, The Angeles Clinic and Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Department of Oncodermatology, University Hospital Centre Nantes, Nantes, Pays de la Loire, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, Eberhard Karls Universitat Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Nyakas', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Skin Cancers Department, Aix-Marseille University, APHM, Marseille, France.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Liszkay', 'Affiliation': 'Department of Oncodermatology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoeller', 'Affiliation': 'Division of General Dermatology and Dermato-Oncology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Unit of Medical Oncology, IRCCS-Regina Elena National Cancer Institute, Rome, Italy.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Grange', 'Affiliation': 'Department of Dermatology, University Hospital Centre Reims, Reims, Champagne-Ardenne, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Operative Dermatology and Dermato-Oncology, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pikiel', 'Affiliation': 'Department of Oncology, Wojewodzkie Centrum Oncologii, Gdańsk, Poland.'}, {'ForeName': 'Fareeda', 'Initials': 'F', 'LastName': 'Hosein', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Burcin', 'Initials': 'B', 'LastName': 'Simsek', 'Affiliation': 'Oncology Clinical Development, Bristol-Myers Squibb Co, Princeton, New Jersey, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Instituto Toscano Tumori, Siena, Italy.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000391']
1090,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM


This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG).
METHODS


Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test.
RESULTS


Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05).
CONCLUSIONS


It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572']
1091,32150239,Five-Year Follow-up of a Randomized Clinical Trial Testing Mailed Nicotine Patches to Promote Tobacco Cessation.,,2020,,[],[],[],[],[],[],,0.0907266,,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cunningham', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Vladyslav', 'Initials': 'V', 'LastName': 'Kushnir', 'Affiliation': ""St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Selby', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zawertailo', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Leatherdale', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schell', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0001']
1092,27486798,"Molecular Identification of Hookworm Isolates in Humans, Dogs and Soil in a Tribal Area in Tamil Nadu, India.","BACKGROUND


Hookworms (Necator americanus and Ancylostoma duodenale) remain a major public health problem worldwide. Infections with hookworms (e.g., A. caninum, A. ceylanicum and A. braziliense) are also prevalent in dogs, but the role of dogs as a reservoir for zoonotic hookworm infections in humans needs to be further explored.
METHODOLOGY/PRINCIPAL FINDINGS


As part of an open-label community based cluster-randomized trial in a tribal area in Tamil Nadu (India; 2013-2015), a total of 143 isolates of hookworm eggs from human stool were speciated based on a previously described PCR-RFLP methodology. The presence of hookworm DNA was confirmed in 119 of 143 human samples. N. americanus (100%) was the most prevalent species, followed by A. caninum (16.8%) and A. duodenale (8.4%). Because of the high prevalence of A. caninum in humans, dog samples were also collected to assess the prevalence of A. caninum in dogs. In 68 out of 77 canine stool samples the presence of hookworms was confirmed using PCR-RFLP. In dogs, both A. caninum (76.4%) and A. ceylanicum (27.9%) were identified. Additionally, to determine the contamination of soil with zoonotic hookworm larvae, topsoil was collected from defecating areas. Hookworm DNA was detected in 72 out of 78 soil samples that revealed presence of hookworm-like nematode larvae. In soil, different hookworm species were identified, with animal hookworms being more prevalent (A. ceylanicum: 60.2%, A. caninum: 29.4%, A. duodenale: 16.6%, N. americanus: 1.4%, A. braziliense: 1.4%).
CONCLUSIONS/SIGNIFICANCE


In our study we regularly detected the presence of A. caninum DNA in the stool of humans. Whether this is the result of infection is currently unknown but it does warrant a closer look at dogs as a potential reservoir.",2016,"In soil, different hookworm species were identified, with animal hookworms being more prevalent (A. ceylanicum: 60.2%, A. caninum: 29.4%, A. duodenale: 16.6%, N. americanus: 1.4%, A. braziliense: 1.4%).
","['As part of an open-label community based cluster-randomized trial in a tribal area in Tamil Nadu (India; 2013-2015), a total of 143 isolates of hookworm eggs from human stool were speciated based on a previously described PCR-RFLP methodology', 'Hookworm Isolates in Humans, Dogs and Soil in a Tribal Area in Tamil Nadu, India']",[],"['Hookworm DNA', 'contamination of soil with zoonotic hookworm larvae, topsoil', 'hookworm DNA']","[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0337946', 'cui_str': 'Tamils (ethnic group)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C3686536', 'cui_str': 'Egg of family Ancylostomatidae (organism)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0035268', 'cui_str': 'RFLP'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C1265425', 'cui_str': 'Family Ancylostomatidae (organism)'}, {'cui': 'C0012984', 'cui_str': 'Canis familiaris'}, {'cui': 'C0349450', 'cui_str': 'Soiling (finding)'}]",[],"[{'cui': 'C1265425', 'cui_str': 'Family Ancylostomatidae (organism)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0349450', 'cui_str': 'Soiling (finding)'}, {'cui': 'C0023047', 'cui_str': 'Larva'}]",,0.0563964,"In soil, different hookworm species were identified, with animal hookworms being more prevalent (A. ceylanicum: 60.2%, A. caninum: 29.4%, A. duodenale: 16.6%, N. americanus: 1.4%, A. braziliense: 1.4%).
","[{'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Levecke', 'Affiliation': 'Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium.'}, {'ForeName': 'Deepthi', 'Initials': 'D', 'LastName': 'Kattula', 'Affiliation': 'Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Vasanthakumar', 'Initials': 'V', 'LastName': 'Velusamy', 'Affiliation': 'Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Geldhof', 'Affiliation': 'Department of Virology, Parasitology and Immunology, Ghent University, Merelbeke, Belgium.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Sarkar', 'Affiliation': 'Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}, {'ForeName': 'Gagandeep', 'Initials': 'G', 'LastName': 'Kang', 'Affiliation': 'Department of Gastrointestinal Sciences, Christian Medical College, Vellore, India.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0004891']
1093,30077178,The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol.,"BACKGROUND


Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns.
METHODS


DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18-35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant's socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression.
DISCUSSION


Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country.
TRIAL REGISTRATION


The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 ).",2018,The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII).,"['pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI', '957 pregnant women aged 18-35\xa0years from ≤20\xa0weeks gestation through 6\xa0months postpartum with 400\xa0mg/d algal-derived DHA or', 'maternal and child health and nutrition in India']","['Maternal docosahexaenoic acid (DHA) supplementation', 'pre- and post-natal DHA maternal supplementation', 'placebo', 'DocosaHexaenoic Acid supplementation']","['infant motor and mental development quotient at 12\xa0months of age evaluated by Development Assessment Scale in Indian Infants (DASII', 'Biochemical indices (blood and breast-milk', 'mean DASII score', 'gestational age, APGAR scores, and infant anthropometry']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0022925', 'cui_str': 'Milk Secretion'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0556102', 'cui_str': 'DHA - Docosahexaenoic acid supplementation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0454729', 'cui_str': 'Natal (geographic location)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005768'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",957.0,0.535859,The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII).,"[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Khandelwal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Gurugram, Haryana, India. shweta.khandelwal@phfi.org.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Swamy', 'Affiliation': ""KLEU's JN Medical College, Belgavi, India.""}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patil', 'Affiliation': ""KLEU's JN Medical College, Belgavi, India.""}, {'ForeName': 'Dimple', 'Initials': 'D', 'LastName': 'Kondal', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Gurugram, Haryana, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chaudhry', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Gurugram, Haryana, India.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Gurugram, Haryana, India.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Sangath, Delhi, Goa, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kamate', 'Affiliation': 'Child Development Centre, Prabhakar Kore Hospital, Belgavi, India.'}, {'ForeName': 'Lakshmy', 'Initials': 'L', 'LastName': 'Ramakrishnan', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Mrutyunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLEU's JN Medical College, Belgavi, India.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Gan', 'Affiliation': ""KLEU's JN Medical College, Belgavi, India.""}, {'ForeName': 'Bhalchandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': 'Research Foundation, KLE University, Belgavi, India.'}, {'ForeName': 'Reynaldo', 'Initials': 'R', 'LastName': 'Martorell', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Srinath Reddy', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Gurugram, Haryana, India.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Public Health Foundation of India, 47, Sector 44, Gurugram, Haryana, India.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, USA.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health Emory University, Atlanta, USA.'}]",BMC pediatrics,['10.1186/s12887-018-1225-5']
1094,32505810,Improving Oral Health and Modulating the Oral Microbiome to Reduce Bloodstream Infections from Oral Organisms in Pediatric and Young Adult Hematopoietic Stem Cell Transplantation Recipients: A Randomized Controlled Trial.,"Bloodstream infections (BSIs) from oral organisms are a significant cause of morbidity and mortality in hematopoietic stem cell transplantation (HSCT) recipients. There are no proven strategies to decrease BSIs from oral organisms. The aim of this study was to evaluate the impact of daily xylitol wipes in improving oral health, decreasing BSI from oral organisms, and modulating the oral microbiome in pediatric HSCT recipients. This was a single-center 1:1 randomized controlled trial in pediatric HSCT recipients age >2 years. Age-matched healthy children were enrolled to compare the oral microbiome. The oral hygiene standard of care (SOC) group continued to receive the standard oral hygiene regimen. The xylitol group received daily oral xylitol wipes (with .7 g xylitol) in addition to the SOC. The intervention started from the beginning of the transplantation chemotherapy regimen and extended to 28 days following transplantation. The primary outcome was oral health at interval time points, and secondary outcomes included BSIs from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance. The study was closed early due to efficacy after an interim analysis of the first 30 HSCT recipients was performed (SOC group, n = 16; xylitol group, n = 14). The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (P = .031, .0039, and .0005, respectively); oral plaque at days 7 and 14 (P = .045 and .0023, respectively); and oral ulcers >10 mm at day 14 (P = .049) compared with the SOC group. The xylitol group had no BSI from oral organisms compared with the SOC group, which had 4 (P = .04). The xylitol group had significantly lower abundance of potential BSI pathogens, such as Staphylococcus aureus (P = .036), Klebsiella pneumoniae (P = .033), and Streptococcus spp (P = .011) at the day after transplantation compared with the SOC group. Healthy children and young adults had significantly increased oral microbiome diversity compared with all HSCT recipients (P < .001). The addition of xylitol to standard oral care significantly improves oral health, decreases BSI from oral organisms, and decreases the abundance of pathogenic oral organisms in pediatric and young adult HSCT recipients.",2020,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","['hematopoietic stem cell transplant (HSCT) recipients', 'Age matched healthy children', 'pediatric HSCT recipients older than 2 years', 'Healthy children and young adults', 'pediatric and young adult HSCT recipients', 'Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients', 'pediatric HSCT recipients']","['daily oral xylitol wipes (with 0.7gm xylitol', 'oral hygiene standard of care (SOC', 'xylitol']","['Klebsiella pneumoniae', 'oral health', 'oral ulcers', 'rate of gingivitis', 'oral microbiome diversity', 'abundance of potential BSI pathogens such as Staphylococcus aureus', 'oral plaque', 'oral health at interval time points, and secondary outcomes included blood stream infections from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance', 'pathogenic oral organism abundance']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",30.0,0.10366,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Badia', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona. Electronic address: pbadia@phoenixchildrens.com.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': ""Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haslam', 'Affiliation': ""Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Nelson', 'Affiliation': ""Center for Cancer and Blood Disorders, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Pate', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Golkari', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Teusink-Cross', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flesch', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Ashely', 'Initials': 'A', 'LastName': 'Bedel', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hickey', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Kramer', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Davies', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Sarat', 'Initials': 'S', 'LastName': 'Thikkurissy', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Dandoy', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.019']
1095,32516810,Effect of the proton-pump Inhibitor pantoprazole on MycoPhenolic ACid exposure in kidney and liver transplant recipienTs (IMPACT study): a randomized trial.,"BACKGROUND


Mycophenolic acid (MPA) is widely utilized as an immunosuppressant in kidney and liver transplantation, with reports suggesting an independent relationship between MPA concentrations and adverse allograft outcome. Proton-pump inhibitors (PPIs) may have variable effects on the absorption of different MPA formulations leading to differences in MPA exposure.
METHODS


A multicentre, randomized, prospective, double-blind placebo-controlled cross-over study was conducted to determine the effect of the PPI pantoprazole on the MPA and its metabolite MPA-glucuronide (MPA-G) area under the curve (AUC) >12 h (MPA-AUC12 h) in recipients maintained on mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium (EC-MPS). We planned a priori to examine separately recipients maintained on MMF and EC-MPS for each pharmacokinetic parameter. The trial (and protocol) was registered with the Australian New Zealand Clinical Trials Registry on 24 March 2011, with the registration number of ACTRN12611000316909 ('IMPACT' study).
RESULTS


Of the 45 recipients screened, 40 (19 MMF and 21 EC-MPS) were randomized. The mean (standard deviation) recipient age was 58 (11) years with a median (interquartile range) time post-transplant of 43 (20-132) months. For recipients on MMF, there was a significant reduction in the MPA-AUC12 h [geometric mean (95% confidence interval) placebo: 53.9 (44.0-65.9) mg*h/L versus pantoprazole: 43.8 (35.6-53.4) mg*h/L; P = 0.004] when pantoprazole was co-administered compared with placebo. In contrast, co-administration with pantoprazole significantly increased MPA-AUC12 h [placebo: 36.1 (26.5-49.2) mg*h/L versus pantoprazole: 45.9 (35.5-59.3) mg*h/L; P = 0.023] in those receiving EC-MPS. Pantoprazole had no effect on the pharmacokinetic profiles of MPA-G for either group.
CONCLUSIONS


The co-administration of pantoprazole substantially reduced the bioavailability of MPA in patients maintained on MMF and had the opposite effect in patients maintained on EC-MPS, and therefore, clinicians should be cognizant of this drug interaction when prescribing the different MPA formulations.",2020,"Pantoprazole had no effect on the pharmacokinetic profiles of MPA-G for either group.
","['recipients maintained on mycophenolate mofetil (MMF) or enteric-coated', 'kidney and liver transplant recipienTs (IMPACT study', '45 recipients screened, 40 (19 MMF and 21 EC-MPS']","['mycophenolate sodium (EC-MPS', 'proton-pump\xa0Inhibitor pantoprazole', 'pantoprazole', 'Mycophenolic acid (MPA', 'PPI pantoprazole', 'Proton-pump inhibitors (PPIs', 'Pantoprazole', 'placebo']","['MPA and its metabolite MPA-glucuronide (MPA-G) area under the curve (AUC', 'pharmacokinetic profiles of MPA-G', 'MPA-AUC12', 'MPA-AUC12\u2009h [geometric mean', 'MycoPhenolic ACid exposure', 'bioavailability of MPA']","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0455647', 'cui_str': 'H/O: liver recipient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}]","[{'cui': 'C1337395', 'cui_str': 'Mycophenolate sodium'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0676811', 'cui_str': 'mycophenolic acid glucuronide'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.35859,"Pantoprazole had no effect on the pharmacokinetic profiles of MPA-G for either group.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sunderland', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Russ', 'Affiliation': 'Department of Nephrology & Transplantation Services, Royal\xa0Adelaide Hospital, and University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Sallustio', 'Affiliation': 'Discipline of Pharmacology, Adelaide Medical School, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cervelli', 'Affiliation': 'Department of Pharmacy, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joyce', 'Affiliation': 'School of Biomedical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Ooi', 'Affiliation': 'School of Biomedical Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Jeffrey', 'Affiliation': 'Faculty of Health and Medical Sciences, Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Chakera', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Gursharan', 'Initials': 'G', 'LastName': 'Dogra', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Wong', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Wai H', 'Initials': 'WH', 'LastName': 'Lim', 'Affiliation': 'Department of Renal Medicine, Sir Charles Gairdner Hospital, Perth, Australia.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa111']
1096,32518012,A multimodality triage algorithm to improve cytoreductive outcomes in patients undergoing primary debulking surgery for advanced ovarian cancer: A Memorial Sloan Kettering Cancer Center team ovary initiative.,"OBJECTIVE


To describe outcomes using a multimodal algorithm to triage patients with advanced epithelial ovarian cancer (EOC) to primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT).
METHODS


All patients with EOC treated at our institution from 04/2015-08/2018 were identified. We included patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score. A low risk score for suboptimal cytoreduction was defined as ≤6, and a high risk score ≥7. Patients were triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score.
RESULTS


Among 299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score. For patients with a low risk score, management included laparotomy/PDS, 181 (80%); LSC, 43 (19%) (with subsequent triage: PDS, 31; NACT, 12); and NACT, 2 (1%). For patients with a high risk score, management included laparotomy/PDS, 9 (12%); LSC, 51 (70%) (with subsequent triage: PDS, 28; NACT, 23); and NACT, 13 (18%). Overall, 83% underwent PDS, with a 75% CGR rate and 94% optimal cytoreduction rate. Use of the algorithm resulted in a 31% LSC rate and a 6% rate of suboptimal PDS.
CONCLUSIONS


The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.",2020,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","['triage patients with advanced epithelial ovarian cancer (EOC', 'patients undergoing primary debulking surgery for advanced ovarian cancer', '299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score', 'All patients with EOC treated at our institution from 04/2015-08/2018 were identified', 'patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score']",['primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT'],"['cytoreductive outcomes', 'triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score']","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",299.0,0.0508146,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","[{'ForeName': 'Alli M', 'Initials': 'AM', 'LastName': 'Straubhar', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Olga T', 'Initials': 'OT', 'LastName': 'Filippova', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Renee A', 'Initials': 'RA', 'LastName': 'Cowan', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lakhman', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Nikolovski', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Torrisi', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Weining', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ginger J', 'Initials': 'GJ', 'LastName': 'Gardner', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Long Roche', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA. Electronic address: longrock@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.041']
1097,32510985,Large Drill Holes Are Still Present in the Long Term After Arthroscopic Bankart Repair With Absorbable Tacks: An 18-Year Randomized Prospective Study.,"BACKGROUND


Studies have demonstrated the development of an osseous reaction at the drill sites of anchors after arthroscopic shoulder surgery.
PURPOSE


To investigate the drill-hole size at 18 years after arthroscopic Bankart repair using either fast polygluconate acid (PGA) or slow polylevolactic acid (PLLA) absorbable tacks and to compare the functional outcomes and development of osteoarthritis.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


40 patients with unidirectional anterior shoulder instability, treated with arthroscopic Bankart repair, were randomized into the PGA group (n = 20) or the PLLA group (n = 20). Plain radiographs of both shoulders, as well as computed tomography (CT) images of the operated shoulder, were used to evaluate the drill-hole size, volume, and degenerative changes. Functional outcomes were assessed by use of the Rowe score, Constant score, and Western Ontario Shoulder Instability (WOSI) index.
RESULTS


Of the 40 patients, 32 patients returned for the follow-up (15 PGA and 17 PLLA). No significant differences were found in the population characteristics between the study groups. The mean follow-up time was 18 years for both groups. No significant differences were seen in range of motion, strength in abduction, or Constant, Rowe, and WOSI scores between the groups. Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P  = .07). The drill-hole appearance on plain radiographs (invisible/hardly visible/visible/cystic) was 11/2/2/0 and 6/5/5/1 for the PGA and PLLA groups, respectively ( P  = .036). The mean ± SD drill-hole volume as estimated on CT images was 89 ± 94 and 184 ± 158 mm 3  in the PGA and PLLA groups, respectively ( P  = .051). Degenerative changes (normal/minor/moderate/severe) on plain radiographs were 7/4/4/0 and 3/8/5/1 for the PGA and PLLA groups, respectively ( P  = .21), and on CT images were 5/7/3/0 and 2/6/6/3 for the PGA and PLLA groups, respectively ( P  = .030).
CONCLUSION


This long-term follow-up study demonstrated that the PLLA group had significantly more visible drill holes than the PGA group on plain radiographs. However, this difference was not evident on CT imaging, with both groups having several visible cystic drill holes and a substantial drill-hole volume defect. No significant differences were found between the study groups in terms of clinical outcomes.",2020,Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P  = .07).,"['40 patients with unidirectional anterior shoulder instability, treated with arthroscopic Bankart repair', '40 patients']","['arthroscopic Bankart repair using either fast polygluconate acid (PGA) or slow polylevolactic acid (PLLA) absorbable tacks', 'Arthroscopic Bankart Repair With Absorbable Tacks', 'PGA', 'PLLA']","['Degenerative changes', 'plain radiographs', 'Rowe score, Constant score, and Western Ontario Shoulder Instability (WOSI) index', 'CT images', 'range of motion, strength in abduction, or Constant, Rowe, and WOSI scores', 'Recurrence rate', 'visible drill holes', 'drill-hole appearance on plain radiographs', 'mean ± SD drill-hole volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}]","[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1101255', 'cui_str': 'polylevolactic acid'}, {'cui': 'C3874006', 'cui_str': 'Tack'}]","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",40.0,0.0322059,Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P  = .07).,"[{'ForeName': 'Christina Chrysanthou', 'Initials': 'CC', 'LastName': 'Constantinou', 'Affiliation': 'NU Hospital Group, Department of Orthopaedics, Trollhättan, Sweden.'}, {'ForeName': 'Ninni', 'Initials': 'N', 'LastName': 'Sernert', 'Affiliation': 'Department of Research and Development, NU Hospital Group, Trollhättan, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rostgård-Christensen', 'Affiliation': 'Department of Radiology, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Kartus', 'Affiliation': 'NU Hospital Group, Department of Orthopaedics, Trollhättan, Sweden.'}]",The American journal of sports medicine,['10.1177/0363546520922191']
1098,32520316,Association of Naturalistic Administration of Cannabis Flower and Concentrates With Intoxication and Impairment.,"Importance


The rapidly growing legal cannabis market includes new and highly potent products, the effects of which, to our knowledge, have not previously been examined in biobehavioral research studies because of federal restrictions on cannabis research.
Objective


To use federally compatible, observational methods to study high-∆9-tetrahydrocannabinol (THC) legal market forms of cannabis.
Design, Setting, and Participants


In this cohort study with a between-groups design that was conducted in a community and university setting, cannabis flower users and concentrate users were randomly assigned to higher- vs lower-THC products within user groups. Participants completed a baseline and an experimental mobile laboratory assessment that included 3 points: before, immediately after, and 1 hour after ad libitum legal market flower and concentrate use. Of the 133 individuals enrolled and assessed, 55 regular flower cannabis users (41.4%) and 66 regular concentrate cannabis users (49.6%) complied with the study's cannabis use instructions and had complete data across primary outcomes.
Exposures


Flower users were randomly assigned to use either 16% or 24% THC flower and concentrate users were randomly assigned to use either 70% or 90% THC concentrate that they purchased from a dispensary.
Main Outcomes and Measures


Primary outcome measures included plasma cannabinoids, subjective drug intoxication, and neurobehavioral tasks testing attention, memory, inhibitory control, and balance.
Results


A total of 121 participants completed the study for analysis: 55 flower users (mean [SD] age, 28.8 [8.1] years; 25 women [46%]) and 66 concentrate users (mean [SD] age, 28.3 [10.4] years; 30 women [45%]). Concentrate users compared with flower users exhibited higher plasma THC levels and 11-hydroxyΔ9-THC (THC's active metabolite) across all points. After ad libitum cannabis administration, mean plasma THC levels were 0.32 (SE = 0.43) μg/mL in concentrate users (to convert to millimoles per liter, multiply by 3.18) and 0.14 (SE = 0.16) μg/mL in flower users. Most neurobehavioral measures were not altered by short-term cannabis consumption. However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use. Differing outcomes for the type of product (flower vs concentrate) or potency within products were not observed.
Conclusions and Relevance


This study provides information about the association of pharmacological and neurobehavioral outcomes with legal market cannabis. Short-term use of concentrates was associated with higher levels of THC exposure. Across forms of cannabis and potencies, users' domains of verbal memory and proprioception-focused postural stability were primarily associated with THC administration.",2020,"However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use.","['community and university setting, cannabis flower users and concentrate users', 'Exposures\n\n\nFlower users', ""133 individuals enrolled and assessed, 55 regular flower cannabis users (41.4%) and 66 regular concentrate cannabis users (49.6%) complied with the study's cannabis use instructions and had complete data across primary outcomes"", '121 participants completed the study for analysis: 55 flower users (mean [SD] age, 28.8 [8.1] years; 25 women [46%]) and 66 concentrate users (mean [SD] age, 28.3']","['THC flower and concentrate users were randomly assigned to use either 70% or 90% THC concentrate that they purchased from a dispensary', 'higher- vs lower-THC products']","[""plasma THC levels and 11-hydroxyΔ9-THC (THC's active metabolite"", 'mean plasma THC levels', 'verbal memory and proprioception-focused postural stability', 'balance function', 'THC exposure', 'delayed verbal memory', 'plasma cannabinoids, subjective drug intoxication, and neurobehavioral tasks testing attention, memory, inhibitory control, and balance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0330090', 'cui_str': 'Flowers'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0589137', 'cui_str': 'Delayed verbal memory'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013221', 'cui_str': 'Poisoning by drug AND/OR medicinal substance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",121.0,0.322435,"However, delayed verbal memory (F1,203 = 32.31; P < .001) and balance function (F1,203 = 18.88; P < .001) were impaired after use.","[{'ForeName': 'L Cinnamon', 'Initials': 'LC', 'LastName': 'Bidwell', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Jarrod M', 'Initials': 'JM', 'LastName': 'Ellingson', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Hollis C', 'Initials': 'HC', 'LastName': 'Karoly', 'Affiliation': 'Institute for Cognitive Science, University of Colorado, Boulder.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'YorkWilliams', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Hitchcock', 'Affiliation': 'Institute for Cognitive Science, University of Colorado, Boulder.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Tracy', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins.'}, {'ForeName': 'Jost', 'Initials': 'J', 'LastName': 'Klawitter', 'Affiliation': 'Division of Substance Dependence, Department of Psychiatry, University of Colorado, Aurora.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Sempio', 'Affiliation': 'Department of Anesthesiology, University of Colorado, Aurora.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}, {'ForeName': 'Kent E', 'Initials': 'KE', 'LastName': 'Hutchison', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado, Boulder.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0927']
1099,32524512,Cost-effectiveness of atezolizumab plus chemotherapy for advanced non-small-cell lung cancer.,"Background Adding atezolizumab to carboplatin/nab-paclitaxel improved progression-free survival and overall survival in patients with advanced non-squamous non-small-cell lung cancer. However, estimating the economy of atezolizumab/carboplatin/nab-paclitaxel is urgent on account of the high cost of atezolizumab. Objective This study aimed to evaluate the cost-effectiveness of atezolizumab plus carboplatin/nab- paclitaxel for untreated advanced non-squamous non-small-cell lung cancer from the United States payer perspective. Setting This study was based on randomized clinical trial data from the IMpower130 (NCT02367781) published in Lancet Oncology (May 2019). Method A Markov model was constructed to estimate the health expenditure on atezolizumab in combination with carboplatin/nab-paclitaxel for advanced non-small-cell lung cancer treatment. Drug costs were collected from Red Book Wholesale Acquisition Cost, and health state utility values were obtained from the literature. Uncertainty was evaluated via one-way and probabilistic sensitivity analyses. Main outcome measure The main outcomes were cost, life years, quality-adjusted life years, and incremental cost-effectiveness ratio. Results Over a 10-year horizon, atezolizumab/carboplatin/nab-paclitaxel treatment was associated with an expected 1.76 life years and 0.99 quality-adjusted life years compared to the 1.21 life years and 0.67 quality-adjusted life years for carboplatin/nab-paclitaxel alone. Compared to carboplatin/nab-paclitaxel, atezolizumab/carboplatin/nab-paclitaxel produced an incremental cost of $105,617. The resultant incremental cost-effectiveness ratio was $333,199 per quality-adjusted life year, which exceeded the willingness-to-pay threshold of $180,000 per quality-adjusted life year. The price of atezolizumab and utility values were the parameters that greatly impacted the incremental cost-effectiveness ratio. Carboplatin/nab-paclitaxel exhibited 98.6% probability of being a cost-effective treatment option compared to atezolizumab/carboplatin/nab-paclitaxel at a willingness-to-pay of $180,000 per quality-adjusted life year. However, reducing atezolizumab acquisition cost by 43.4% could make atezolizumab/carboplatin/nab-paclitaxel more cost-effective than carboplatin/nab-paclitaxel. Conclusion Adding atezolizumab to carboplatin/nab-paclitaxel was not cost-effective for advanced non-squamous non-small-cell lung cancer in the base-case scenario. Decreasing atezolizumab acquisition cost might enhance the cost-effectiveness.",2020,"Carboplatin/nab-paclitaxel exhibited 98.6% probability of being a cost-effective treatment option compared to atezolizumab/carboplatin/nab-paclitaxel at a willingness-to-pay of $180,000 per quality-adjusted life year.","['patients with advanced non-squamous non-small-cell lung cancer', 'advanced non-small-cell lung cancer', 'untreated advanced non-squamous non-small-cell lung cancer from the United States payer perspective']","['atezolizumab plus chemotherapy', 'atezolizumab to carboplatin/nab-paclitaxel', 'atezolizumab/carboplatin/nab-paclitaxel', 'carboplatin/nab-paclitaxel', 'atezolizumab plus carboplatin/nab- paclitaxel', 'atezolizumab in combination with carboplatin/nab-paclitaxel', 'carboplatin/nab-paclitaxel, atezolizumab/carboplatin/nab-paclitaxel', 'Carboplatin/nab-paclitaxel']","['atezolizumab acquisition cost', 'cost, life years, quality-adjusted life years, and incremental cost-effectiveness ratio', 'Red Book Wholesale Acquisition Cost, and health state utility values', 'incremental cost-effectiveness ratio', 'Drug costs', 'cost-effectiveness', 'progression-free survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0725535,"Carboplatin/nab-paclitaxel exhibited 98.6% probability of being a cost-effective treatment option compared to atezolizumab/carboplatin/nab-paclitaxel at a willingness-to-pay of $180,000 per quality-adjusted life year.","[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Shaohong', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Lixian', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'College of Pharmacy, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Dayong', 'Initials': 'D', 'LastName': 'Zeng', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Rao', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China.""}, {'ForeName': 'Pinfang', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China. 2363869908@qq.com.""}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': ""Department of Pharmacy, First Affiliated Hospital of Fujian Medical University, Chazhong Road NO. 20, Fuzhou, Fujian, People's Republic of China. wxh001@fjmu.edu.cn.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01076-3']
1100,32518064,GIP and GLP-1 Potentiate Sulfonylurea-Induced Insulin Secretion in Hepatocyte Nuclear Factor 1α Mutation Carriers.,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1α (HNF1A) diabetes, but SUs have limitations due to risk of hypoglycemia. Treatment based on the incretin hormones glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) is characterized by their glucose-dependent insulinotropic actions without risk of hypoglycemia. The effect of SUs together with GIP or GLP-1, respectively, on insulin and glucagon secretion in patients with HNF1A diabetes is currently unknown. To investigate this, 10  HNF1A  mutation carriers and 10 control subjects without diabetes were recruited for a double-blinded, placebo-controlled, crossover study including 6 experimental days in a randomized order involving 2-h euglycemic-hyperglycemic clamps with coadministration of:  1 ) SU (glimepiride 1 mg) or placebo, combined with  2 ) infusions of GIP (1.5 pmol/kg/min), GLP-1 (0.5 pmol/kg/min), or saline (NaCl). In  HNF1A  mutation carriers, we observed:  1 ) hypoinsulinemia,  2 ) insulinotropic effects of both GIP and GLP-1,  3 ) additive to supra-additive effects on insulin secretion when combining SU+GIP and SU+GLP-1, respectively, and  4 ) increased fasting and arginine-induced glucagon levels compared with control subjects without diabetes. Our study suggests that a combination of SU and incretin-based treatment may be efficacious in patients with HNF1A diabetes via potentiation of glucose-stimulated insulin secretion.",2020,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia.","['patients with HNF1A-diabetes', 'patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes', 'ten  HNF1A  mutation carriers and ten non-diabetic controls']","['GIP and GLP-1', 'euglycemic-hyperglycemic clamps with co-administration of 1) SU (glimepiride 1 mg) or placebo, combined with 2) infusions of either GIP', 'GLP-1 (0.5 pmol/kg/min) or saline (NaCl', 'Sulfonylureas (SUs', 'placebo']","['fasting and arginine-induced glucagon levels', 'insulin and glucagon secretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451774', 'cui_str': 'HNF1A protein, human'}, {'cui': 'C0209278', 'cui_str': 'Liver-Specific Transcription Factor LF-B1'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0986239', 'cui_str': 'glimepiride 1 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0574518', 'cui_str': 'Susu language'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",,0.0900443,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia.","[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes,['10.2337/db20-0074']
1101,32519599,Patients' and caregivers' experiences of driving with chronic breathlessness before and after regular low-dose sustained-release morphine: A qualitative study.,"BACKGROUND


Chronic breathlessness is a disabling syndrome that profoundly impacts patients' and caregivers' lives. Driving is important for most people, including those with advanced disease. Regular, low-dose, sustained-release morphine safely reduces breathlessness, but little is known about its impact on driving.
AIM


To understand patients' and caregivers' (1) perspectives and experiences of driving with chronic breathlessness; and (2) perceived impact of regular, low-dose, sustained-release morphine on driving.
DESIGN


A qualitative study embedded in a pragmatic, phase III, randomised, placebo-controlled trial of low-dose, sustained-release morphine (⩽32 mg/24 h) for chronic breathlessness. Semi-structured interviews were conducted immediately after participants withdrew or completed the randomised, placebo-controlled trial. Informed by grounded theory, a constant comparative approach to analysis was adopted.
SETTING/PARTICIPANTS


Participants were recruited from an outpatients palliative care service in Adelaide, Australia. Participants included patients ( n  = 13) with severe breathlessness associated with chronic obstructive pulmonary disease and their caregivers ( n  = 9).
RESULTS


Participants were interviewed at home. Eleven received morphine 8-32 mg. Three themes emerged: (1) independence; (2) breathlessness' impact on driving; and (3) driving while taking regular, low-dose, sustained-release morphine.
CONCLUSION


Driving contributed to a sense of identity and independence. Being able to drive increased the physical and social space available to patients and caregivers, their social engagement and well-being. Patients reported breathlessness at rest may impair driving skills, while the introduction of sustained-release morphine seemed to have no self-reported impact on driving. Investigating this last perception objectively, especially in terms of safety, is the subject of ongoing work.",2020,"Being able to drive increased the physical and social space available to patients and caregivers, their social engagement and well-being.","['Participants included patients ( n \u2009=\u200913) with severe breathlessness associated with chronic obstructive pulmonary disease and their caregivers ( n \u2009=\u20099', 'Participants were interviewed at home', ""Patients' and caregivers' experiences of driving with chronic breathlessness before and after regular low-dose sustained-release"", 'Participants were recruited from an outpatients palliative care service in Adelaide, Australia']","['placebo', 'sustained-release morphine', 'morphine']","[""independence; (2) breathlessness' impact on driving; and (3) driving while taking regular, low-dose, sustained-release morphine""]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",,0.0508524,"Being able to drive increased the physical and social space available to patients and caregivers, their social engagement and well-being.","[{'ForeName': 'Diana H', 'Initials': 'DH', 'LastName': 'Ferreira', 'Affiliation': 'Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Boland', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Slavica', 'Initials': 'S', 'LastName': 'Kochovska', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, NSW, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Honson', 'Affiliation': 'Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, NSW, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'Palliative and Supportive Services, Flinders University, Bedford Park, SA, Australia.'}]",Palliative medicine,['10.1177/0269216320929549']
1102,32524948,Rapid Reduction of  Campylobacter  Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial.,"Campylobacter  has emerged as a potential important cause of childhood morbidity in sub-Saharan Africa. Biannual mass azithromycin distribution has previously been shown to reduce all-cause child mortality in sub-Saharan Africa. We conducted a randomized controlled trial in Burkina Faso in which children were randomized in a 1:1 fashion to a 5-day course of azithromycin or placebo to investigate the effect of oral antibiotics on the gut microbiome. We evaluated the changes in the gut microbiome of preschool children treated with azithromycin using metagenomic DNA sequencing. We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo. These results were consistent with other studies that have shown decreases in  Campylobacter  species after azithromycin treatment, generating the hypothesis that a decrease in  Campylobacter  may contribute to observations of reduction in mortality following azithromycin distribution.",2020,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"['Preschool Children after Oral', 'preschool children treated with']","['azithromycin', 'Azithromycin', 'azithromycin or placebo', 'placebo']",[],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0812107,We found that three  Campylobacter  species were reduced with azithromycin treatment compared with placebo.,"[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Cindi', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0940']
1103,32520654,Effects of an Individualized Active Aging Counseling Intervention on Mobility and Physical Activity: Secondary Analyses of a Randomized Controlled Trial.,"Objectives:  The aim of this study was to report preplanned secondary analyses of the effects of a 12-month individualized active aging counseling intervention on six mobility and physical activity outcomes.  Methods:  A two-arm, single-blinded randomized controlled trial was conducted among 75- and 80-year-old community-dwelling people. The intervention group (IG,  n  = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity. The control group (CG,  n  = 103) received general health information. Data were analyzed with generalized estimating equations.  Results:  Physical performance improved in the IG more than that in the CG (group by time  p  = .022), self-reported physical activity increased in both groups (time  p  = .012), and autonomy in outdoor mobility declined in the IG and was enhanced in the CG (group by time  p  = .011). No change was observed for life-space mobility, proportion of persons perceiving difficulty walking 2 km, or monitored physical activity.  Discussion:  Individualized counseling aiming at increasing self-selected out-of-home activity had nonsystematic effects on mobility and positively affected physical performance only.",2020,Results:  Physical performance improved in the IG more than that in the CG (group by time  p  = .022),['75- and 80-year-old community-dwelling people'],"['Individualized counseling', 'Individualized Active Aging Counseling Intervention', 'intervention group (IG,  n  = 101) received counseling aimed at increasing self-selected, primarily out-of-home activity', 'individualized active aging counseling intervention', 'CG', 'general health information']","['six mobility and physical activity outcomes', 'autonomy in outdoor mobility', 'physical activity', 'life-space mobility, proportion of persons perceiving difficulty walking 2\xa0km, or monitored physical activity', 'Physical performance', 'Mobility and Physical Activity']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0311394', 'cui_str': 'Difficulty walking'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.034241,Results:  Physical performance improved in the IG more than that in the CG (group by time  p  = .022),"[{'ForeName': 'Sini', 'Initials': 'S', 'LastName': 'Siltanen', 'Affiliation': 'University of Jyvaskyla, Finland.'}, {'ForeName': 'Erja', 'Initials': 'E', 'LastName': 'Portegijs', 'Affiliation': 'University of Jyvaskyla, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Pynnönen', 'Affiliation': 'University of Jyvaskyla, Finland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hassandra', 'Affiliation': '37786University of Thessaly, Greece.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Rantalainen', 'Affiliation': 'University of Jyvaskyla, Finland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Karavirta', 'Affiliation': 'University of Jyvaskyla, Finland.'}, {'ForeName': 'Milla J', 'Initials': 'MJ', 'LastName': 'Saajanaho', 'Affiliation': 'University of Jyvaskyla, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'University of Jyvaskyla, Finland.'}]",Journal of aging and health,['10.1177/0898264320924258']
1104,31854221,Sparing the pronator quadratus for volar plating of distal radius fractures: a comparative study of two methods.,"OBJECTIVES


The objective of this study was to compare the results of two methods for sparing the pronator quadratus in volar plating of distal radius fractures.
METHODS


A total of 110 patients were randomized to volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method (Group B, 55 people). The operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications were recorded.
RESULTS


There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups. We found no significant differences in range of motion, grip strength, VAS scores, and DASH scores at any of the study intervals between the groups. Although neurapraxia of the superficial branch of the radial nerve was more common in Group B than in Group A (6.7% vs. 0%), the difference was not significant.
CONCLUSIONS


Both methods were efficient approaches for sparing the pronator quadratus and had similar clinical outcomes, but they had different indications.",2020,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","['110 patients', 'distal radius fractures']","['volar plating with sparing of the pronator quadratus either by a transverse incision along the distal border of the pronator quadratus (Group A, 55 people) or by the brachioradialis splitting method']","['range of motion, grip strength, VAS scores, and DASH scores', 'mean operative time, radiation time, mean bone union time, or total complication rate', 'operative and radiation time, range of motion, grip strength, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, Visual Analog Scale (VAS) scores, and complications']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0224263', 'cui_str': 'Structure of pronator quadratus muscle'}, {'cui': 'C1261209', 'cui_str': 'Transverse incision'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0224264', 'cui_str': 'Structure of brachioradialis muscle'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",110.0,0.0516226,"There were no significant differences in the mean operative time, radiation time, mean bone union time, or total complication rate between the groups.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Yun-Qiang', 'Initials': 'YQ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Gang-Qiang', 'Initials': 'GQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ya-Di', 'Initials': 'YD', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedic Surgery, Ningbo No.6 Hospital, Ningbo, Zhejiang, China.'}]",The Journal of international medical research,['10.1177/0300060519893851']
1105,32526017,Transcranial Direct Current Stimulation Combined With Therapeutic Exercise in Chronic Low Back Pain: Protocol of a Randomized Controlled Trial.,"OBJECTIVE


Although some studies have shown the clinical benefits of therapeutic exercise in chronic nonspecific low back pain, the effect sizes are generally small to moderate and recurrence rates are high. Transcranial direct current stimulation (tDCS) has been used to modulate pain-processing systems and motor outputs and has the potential to optimize the clinical benefits of therapeutic exercise. However, evidence for this combination is still lacking. The purpose of this protocol for a randomized clinical trial is to investigate whether the combination of tDCS and therapeutic exercise is more effective in relieving pain than therapeutic exercise alone.
METHODS


This 2-arm, randomized controlled clinical trial will take place at the Federal University of Piauí, Brazil. Sixty patients will be randomized into 2 groups to receive tDCS (real/sham) + exercise therapies for 12 sessions over a period of 4 weeks. Pain intensity, sensory and affective aspects of pain, physical functioning, kinesiophobia, and global perceived effect will be recorded before treatment and at 4 weeks, 3 months, and 6 months after randomization. Data will be collected by an examiner unaware of (blind to) the treatment allocation.
IMPACT


This trial can potentially provide important information and assist in clinical decision-making on the combined use of tDCS to optimize the clinical benefits of therapeutic exercise in patients with chronic nonspecific low back pain.",2020,,['Chronic Low Back Pain'],"['Transcranial Direct Current Stimulation (tDCS', 'Therapeutic Exercise']",[],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}]",[],,0.160382,,"[{'ForeName': 'Polyanna Gomes Lacerda', 'Initials': 'PGL', 'LastName': 'Cavalcante', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, PI - Brazil.'}, {'ForeName': 'Abrahão Fontes', 'Initials': 'AF', 'LastName': 'Baptista', 'Affiliation': 'Center for Mathematics, Computation and Cognition, Universidade Federal do ABC, São Bernardo do Campo, SP - Brazil.'}, {'ForeName': 'Vinícius Saura', 'Initials': 'VS', 'LastName': 'Cardoso', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui.'}, {'ForeName': 'Marcelo de Carvalho', 'Initials': 'MC', 'LastName': 'Filgueiras', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui.'}, {'ForeName': 'Renata Hydee', 'Initials': 'RH', 'LastName': 'Hasue', 'Affiliation': 'Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Doctoral Programs in Rehabilitation Sciences, Faculdade de Medicina da Universidade de São Paulo - USP, São Paulo, SP - Brazil.'}, {'ForeName': 'Silvia Maria Amado', 'Initials': 'SMA', 'LastName': 'João', 'Affiliation': 'Department of Physical Therapy, Communication Sciences and Disorders, and Occupational Therapy, Doctoral Programs in Rehabilitation Sciences, Faculdade de Medicina da Universidade de São Paulo.'}, {'ForeName': 'Fuad Ahmad', 'Initials': 'FA', 'LastName': 'Hazime', 'Affiliation': 'Department of Physical Therapy, Biomedical Master Science Program, Universidade Federal do Piaui, Parnaíba, Avenida São Sebastião, 2819, CEP: 64202-020 Parnaíba, PI - Brazil.'}]",Physical therapy,['10.1093/ptj/pzaa105']
1106,32519005,Hypertonic saline for fluid resuscitation in ICU patients post-cardiac surgery (HERACLES): a double-blind randomized controlled clinical trial.,"PURPOSE


Recent evidence questions a liberal approach to fluid resuscitation in intensive care unit (ICU) patients. Here, we assess whether use of hypertonic saline applied as single infusion at ICU admission after cardiac surgery can reduce cumulative perioperative fluid volume.
METHODS


Prospective randomized double-blind single-center clinical trial investigates effects of a single infusion of hypertonic saline (HS) versus normal saline (comparator). Primary endpoint was the cumulative amount of fluid administered in patients in the hypertonic saline versus the 0.9% saline groups (during ICU stay). Upon ICU admission, patients received a single infusion of 5 ml/kg body weight of 7.3% NaCl (or 0.9% NaCl) over 60 min. Patients undergoing cardiac surgery for elective valvular and/or coronary heart disease were included. Patients with advanced organ dysfunction, infection, and/or patients on chronic steroid medication were excluded.
RESULTS


A total of 101 patients were randomized to receive the study intervention (HS n = 53, NS n = 48). Cumulative fluid intake on the ICU (primary endpoint) did not differ between the HS and the NS groups [median 3193 ml (IQR 2052-4333 ml) vs. 3345 ml (IQR 2332-5043 ml)]. Postoperative urinary output until ICU discharge was increased in HS-treated patients [median 2250 ml (IQR 1640-2690 ml) vs. 1545 ml (IQR 1087-1976 ml)], and ICU fluid balance was lower in the HS group when compared to the NS group [296 ml (IQR - 441 to 1412 ml) vs. 1137 ml (IQR 322-2660 ml)].
CONCLUSION


In a monocentric prospective double-blind randomized clinical trial, we observed that hypertonic saline did not reduce the total fluid volume administered on the ICU in critically ill cardiac surgery patients. Hypertonic saline infusion was associated with timely increase in urinary output. Variations in electrolyte and acid-base homeostasis were transient, but substantial in all patients.",2020,Primary endpoint was the cumulative amount of fluid administered in patients in the hypertonic saline versus the 0.9% saline groups (during ICU stay).,"['ICU patients post-cardiac surgery (HERACLES', 'intensive care unit (ICU) patients', 'Patients with advanced organ dysfunction, infection, and/or patients on chronic steroid medication were excluded', '101 patients', 'critically ill cardiac surgery patients', 'Patients undergoing cardiac surgery for elective valvular and/or coronary heart disease']","['hypertonic saline (HS) versus normal saline (comparator', 'hypertonic saline', 'Hypertonic saline']","['Postoperative urinary output until ICU discharge', 'cumulative amount of fluid', 'ICU fluid balance', 'total fluid volume', 'urinary output', 'Cumulative fluid intake']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}]",101.0,0.791992,Primary endpoint was the cumulative amount of fluid administered in patients in the hypertonic saline versus the 0.9% saline groups (during ICU stay).,"[{'ForeName': 'Carmen A', 'Initials': 'CA', 'LastName': 'Pfortmueller', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland. Carmen.Pfortmueller@insel.ch.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Kindler', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Noelle', 'Initials': 'N', 'LastName': 'Schenk', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Messmer', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hess', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Wenger', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Waskowski', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zuercher', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Stoehr', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Englberger', 'Affiliation': 'Department of Cardiovascular Surgery, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Joerg C', 'Initials': 'JC', 'LastName': 'Schefold', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010, Bern, Switzerland.'}]",Intensive care medicine,['10.1007/s00134-020-06132-0']
1107,32520991,"l-Serine and EPA Relieve Chronic Low-Back and Knee Pain in Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Multisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life.
OBJECTIVES


This study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo.
METHODS


This was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates.
RESULTS


The JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P < 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11-27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed.
CONCLUSIONS


l-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment.This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.",2020,"No adverse events were observed.
","['120 participants aged\xa0≥20 y (36 men and 84 women: mean\xa0±\xa0SD age = 40.8\xa0±\xa010.9 y', 'Adults', 'adults with pain in at least the low back and knee for\xa0≥3 mo']","['Placebo', 'l-Serine and EPA', 'l-serine', 'l-Serine and EPA Relieve', 'mg l-serine and 149\xa0mg EPA', 'active group (daily ingestion of 594', 'placebo']","['Chronic Low-Back and Knee Pain', 'JKOM scores', 'BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving', 'BPI5D', 'pain relief', 'Brief Pain Inventory (BPI) and safety evaluation', 'JLEQ scores', 'adverse events', 'Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036720', 'cui_str': 'Serine'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",120.0,0.682536,"No adverse events were observed.
","[{'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Sasahara', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Takeshita', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Suga', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Nishikata', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Takada', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Direct Marketing Department, Ajinomoto Co, Inc, Tokyo, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Mine', 'Affiliation': 'Institute of Food Sciences and Technologies, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Kobuna', 'Affiliation': 'Kobuna Orthopedic Clinic, Maebashi, Gunma, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nagao', 'Affiliation': 'Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co, Inc, Kawasaki, Kanagawa, Japan.'}]",The Journal of nutrition,['10.1093/jn/nxaa156']
1108,32524991,Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials.,"BACKGROUND


Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.
OBJECTIVE


Our aim was to determine omalizumab safety and efficacy in CRSwNP in phase 3 trials (POLYP 1 and POLYP 2).
METHODS


Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score. Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22) score, University of Pennsylvania Smell Identification Test, sense of smell, postnasal drip, runny nose, and adverse events.
RESULTS


Patients in POLYP 1 (n = 138) and POLYP 2 (n = 127) exhibited severe CRSwNP and substantial quality of life impairment evidenced by a mean NPS higher than 6 and SNOT-22 score of approximately 60. Both studies met both the coprimary end points. SNOT-22 score, University of Pennsylvania Smell Identification Test score, sense of smell, postnasal drip, and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, the mean changes from baseline at week 24 for omalizumab versus placebo were as follows: NPS, -1.08 versus 0.06 (P < .0001) and -0.90 versus -0.31 (P = .0140); Nasal Congestion Score, -0.89 versus -0.35 (P = .0004) and -0.70 versus -0.20 (P = .0017); and SNOT-22 score, -24.7 versus -8.6 (P < .0001) and -21.6 versus -6.6 (P < .0001). Adverse events were similar between groups.
CONCLUSION


Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and it was well tolerated.",2020,"The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.
","['nasal polyposis', 'Adults with CRSwNP with inadequate response to intranasal corticosteroids', 'Chronic rhinosinusitis with nasal polyps (CRSwNP', 'patients with CRSwNP and comorbid asthma previously', 'Patients in POLYP 1']","['omalizumab or placebo and intranasal mometasone', 'CRSwNP', 'Omalizumab', 'omalizumab', 'placebo']","['change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), sense of smell, postnasal drip, runny nose, and adverse events (AEs', 'tolerated', 'Efficacy and safety', 'SNOT-22, UPSIT, sense of smell, postnasal drip and runny nose', 'Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS', 'severe CRSwNP and substantial quality-of-life impairment']","[{'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.169777,"The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Omachi', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif. Electronic address: omachi.theodore@gene.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Departments of Medicine and Pediatrics, David Geffen School of Medicine at UCLA, Los Angeles, Calif.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Mullol', 'Affiliation': 'Hospital Clinic, IDIBAPS, Universitat de Barcelona, CIBERES, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Va.'}, {'ForeName': 'Stella E', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Kaufman', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ligueros-Saylan', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Monet', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Genentech, Inc, South San Francisco, Calif.'}, {'ForeName': 'Lutaf', 'Initials': 'L', 'LastName': 'Islam', 'Affiliation': 'Roche, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Bachert', 'Affiliation': 'Upper Airway Research Laboratory, Department of Otorhinolaryngology, Ghent University Hospital, Ghent, Belgium; Division of ENT Diseases, CLINTEC, Karolinska Institute, Stockholm, Sweden.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.032']
1109,32525517,Association of Weight-Adjusted Caffeine and β-Blocker Use With Ophthalmology Fellow Performance During Simulated Vitreoretinal Microsurgery.,"Importance


Vitreoretinal surgery can be technically challenging and is limited by physiologic characteristics of the surgeon. Factors that improve accuracy and precision of the vitreoretinal surgeon are invaluable to surgical performance.
Objectives


To establish weight-adjusted cutoffs for caffeine and β-blocker (propranolol) intake and to determine their interactions in association with the performance of novice vitreoretinal microsurgeons.
Design, Settings, and Participants


This single-blind cross-sectional study of 15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting. Five simulations were performed daily for 2 days. On day 1, performance was assessed after sequential exposure to placebo, low-dose caffeine (2.5 mg/kg), high-dose caffeine (5.0 mg/kg), and high-dose propranolol (0.6 mg/kg). On day 2, performance was assessed after sequential exposure to placebo, low-dose propranolol (0.2 mg/kg), high-dose propranolol (0.6 mg/kg), and high-dose caffeine (5.0 mg/kg).
Interventions


Surgical simulation tasks were repeated 30 minutes after masked ingestion of placebo, caffeine, or propranolol pills during the 2 days.
Main Outcomes and Measures


An Eyesi surgical simulator was used to assess surgical performance, which included surgical score (range, 0 [worst] to 700 [best]), task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best]). The nonparametric Friedman test followed by Dunn-Bonferroni post hoc test was applied for multiple comparisons.
Results


Of 15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9). Compared with low-dose propranolol, low-dose caffeine was associated with a worse total surgical score (557.0 vs 617.0; difference, -53.0; 95% CI, -99.3 to -6.7; P = .009), a lower antitremor maneuver score (55.0 vs 75.0; difference, -12.0; 95% CI, -21.2 to -2.8; P = .009), longer intraocular trajectory (2298.6 vs 2080.7 mm; difference, 179.3 mm; 95% CI, 1.2-357.3 mm; P = .048), and increased task completion time (14.9 minutes vs 12.7 minutes; difference, 2.3 minutes; 95% CI, 0.8-3.8 minutes; P = .048). Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03).
Conclusions and Relevance


The findings suggest that performance of novice vitreoretinal surgeons was worse after receiving low-dose caffeine alone but improved after receiving low-dose propranolol alone. Their performance after receiving propranolol alone was better than after the combination of propranolol and caffeine. These results may be helpful for novice vitreoretinal surgeons to improve microsurgical performance.",2020,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03).
","['15 vitreoretinal surgeons, 9 (60%) were male, with a mean (SD) age of 29.6 (1.4) years and mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) of 23.15 (2.9', '15 vitreoretinal surgeons who had less than 2 years of surgical experience was conducted from September 19, 2018, to September 25, 2019, at a dry-laboratory setting']","['placebo, low-dose propranolol', 'Postcaffeine', 'placebo, low-dose caffeine', 'propranolol and caffeine', 'caffeine', 'placebo, caffeine, or propranolol pills', 'caffeine and β-blocker (propranolol', 'propranolol']","['intraocular trajectory', 'surgical performance, which included surgical score (range, 0', 'lower antitremor maneuver score', 'total surgical score', 'task completion time', 'tremor-specific score', 'longer intraocular trajectory', 'task completion time, intraocular trajectory, and tremor rate (range, 0 [worst] to 100 [best']","[{'cui': 'C1720040', 'cui_str': 'Retinal surgeon'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3217257', 'cui_str': 'Propranolol Pill'}]","[{'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",5.0,0.394633,"Postcaffeine treatment with propranolol was associated with performance improvement; however, surgical performance remained inferior compared with low-dose propranolol alone for total surgical score (570.0 vs 617.0; difference, -51.0; 95% CI, -77.6 to -24.4; P = .01), tremor-specific score (50.0 vs 75.0; difference, -16.0; 95% CI, -31.8 to -0.2; P = .03), and intraocular trajectory (2265.9 mm vs 2080.7 mm; difference, 166.8 mm; 95% CI, 64.1-269.6 mm; P = .03).
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Roizenblatt', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vitor', 'Initials': 'V', 'LastName': 'Dias Gomes Barrios Marin', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alex Treiger', 'Initials': 'AT', 'LastName': 'Grupenmacher', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Muralha', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Neurology and Neurosurgery, Neuroengineering and Neurocognition Laboratory, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jiramongkolchai', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Peter Louis', 'Initials': 'PL', 'LastName': 'Gehlbach', 'Affiliation': 'Johns Hopkins University School of Medicine, The Wilmer Eye Institute, Baltimore, Maryland.'}, {'ForeName': 'Michel Eid', 'Initials': 'ME', 'LastName': 'Farah', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Belfort', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Department of Ophthalmology, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.1971']
1110,32530412,The Effects of Intensive Versus Routine Treatment in Patients with Acute Kidney Injury.,"BACKGROUND


In patients with acute kidney injury (AKI), specialized treatment-initiated in response to an early-warning system- may be beneficial compared with routine treatment.
METHOD


To explore effect estimators in a pilot trial (DRKS00010530), patients with AKI on regular wards of a university hospital were treated either in the usual way (control group) or more intensively (intervention group). The subjects were allotted randomly to the two treatment groups. The more intensive treatment consisted of an early warning system for a rise in the serum creatinine concentration, immediate consultation of a specialist, and the issuance of a patient kidney passport. The primary endpoint was recovery of renal function after AKI during the index hospitalization. Renal complications and process indicators were the secondary endpoints.
RESULTS


The proportion of patients whose renal function returned to baseline after AKI was 50% in the intervention group (N = 26) and 42% in the control group (N = 26) (odds ratio 1.4, 95% confidence interval [0.5; 4.0], p = 0.58). The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile: [6; -20]) in the intervention group and by 13 mL/min/1.73 m2 in the control group (1st-3rd quartile: [0; -25]; p = 0.09). Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis were rarer in the intervention group (15% versus 39%; p = 0.03). In the intervention group, compared with the control group, the cause of AKI was identified more frequently (27% versus 4%; p = 0.05); drugs with relevance to the kidney were discontinued more frequently (65% versus 31%; p = 0.01); and the diagnosis of AKI was more frequently documented in the patient's chart (58% versus 37%; p = 0.03).
CONCLUSION


Specialized consultations supported by an early warning system for AKI seem to be beneficial for patients. The findings of this pilot trial should be verified in larger-scale randomized controlled trials.",2020,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","['patients with acute kidney injury (AKI', 'Patients with Acute Kidney Injury', 'patients with AKI on regular wards of a university hospital']",['Intensive Versus Routine Treatment'],"['cause of AKI', 'renal function', 'recovery of renal function', 'calculated glomerular filtration rate', 'diagnosis of AKI', 'Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}]",,0.061064,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haase-Fielitz', 'Affiliation': 'Department of Cardiology, Brandenburg Heart Center, Immanuel Hospital, Bernau; Brandenburg Medical School Theodor Fontane; Institute of Social Medicine and Health Systems Research, Magdeburg University, Magdeburg; Department of Nephrology and Endocrinology, Ernst von Bergmann Hospital, Potsdam; Department of Urology and Pediatric Urology, Magdeburg University Hospital, Magdeburg; Department of Orthopedics and Trauma Surgery, Ameos Hospital, Schönebeck; Institute of Laboratory Medicine, Leipzig University Hospital, Leipzig; Diaverum Renal Care Center Am Neuen Garten, Potsdam; Faculty of Medicine, Otto-von-Guericke University of Magdeburg; Department of Nephrology, Essen University Hospital, Essen.'}, {'ForeName': 'Saban', 'Initials': 'S', 'LastName': 'Elitok', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schostak', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Isermann', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Bernt-Peter', 'Initials': 'BP', 'LastName': 'Robra', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haase', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0289']
1111,32527270,Family-centeredness of childhood obesity interventions: psychometrics & outcomes of the family-centered care assessment tool.,"BACKGROUND


Incorporating family-centered care principles into childhood obesity interventions is integral for improved clinical decision making, better follow-through, and more effective communication that leads to better outcomes and greater satisfaction with services. The purpose of this study is to evaluate the psychometric properties of a modified version of the Family Centered-Care Assessment (mFCCA) tool and to assess the family-centeredness of two clinical-community childhood obesity interventions.
METHODS


Connect for Health was a randomized trial testing the comparative effectiveness of two interventions that enrolled 721 children, ages 2-12 years, with a body mass index (BMI) ≥ 85th percentile. The two arms were (1) enhanced primary care; and (2) enhanced primary care plus contextually-tailored, health coaching. At the end of the one-year intervention, the mFCCA was administered. We used Rasch analyses to assess the tool's psychometrics and examined differences between the groups using multiple linear regression.
RESULTS


629 parents completed the mFCCA resulting in an 87% response rate. The mean (SD) age of children was 8.0 (3.0) years. The exploratory factor analysis with 24 items all loaded onto a single factor. The Rasch modeling demonstrated good reliability as evidenced by the person separation reliability coefficient (0.99), and strong validity as evidenced by the range of item difficulty and overall model fit. The mean (SD, range) mFCCA score was 4.14 (0.85, 1-5). Compared to parents of children in the enhanced primary care arm, those whose children were in the enhanced primary care plus health coaching arm had higher mFCCA scores indicating greater perception of family-centeredness (β = 0.61 units [95% CI: 0.49, 0.73]).
CONCLUSIONS


Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02124460.",2020,"Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management.
","['enrolled 721 children, ages 2-12\u2009years, with a body mass index (BMI)\u2009≥\u200985th percentile', 'parents of children with obesity']","['modified version of the Family Centered-Care Assessment (mFCCA', 'primary care plus contextually-tailored, health coaching', 'mFCCA']","['mFCCA scores', 'mean (SD, range) mFCCA score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",721.0,0.0180158,"Using the mFCCA which demonstrated good psychometric properties for the assessment of family-centered care among parents of children with obesity, we found that individualized health coaching is a family-centered approach to pediatric weight management.
","[{'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Simione', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA. msimione@mgh.harvard.edu.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Section of General Pediatrics, Department of Pediatrics, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Monica W', 'Initials': 'MW', 'LastName': 'Gerber', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Marshall', 'Affiliation': 'Department of Pediatrics, Harvard Vanguard Medical Associates, Boston, MA, USA.'}, {'ForeName': 'Earlene', 'Initials': 'E', 'LastName': 'Avalon', 'Affiliation': 'Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Fiechtner', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Horan', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Skelton', 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Elsie M', 'Initials': 'EM', 'LastName': 'Taveras', 'Affiliation': 'Division of General Academic Pediatrics, Department of Pediatrics, MassGeneral Hospital for Children, 125 Nashua Street, Suite 860, Boston, MA, 02114, USA.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01431-y']
1112,32531798,"Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies.","BACKGROUND


Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic.
OBJECTIVES


To report 3-year safety data from three phase III trials of CZP in adults with plaque psoriasis.
METHODS


Data were pooled from CIMPASI-1 (NCT02326298), CIMPASI-2 (NCT02326272) and CIMPACT (NCT02346240). Included patients had moderate-to-severe plaque psoriasis of ≥ 6 months' duration; had been randomized to CZP 200 mg every 2 weeks (Q2W) (400 mg at weeks 0, 2 and 4) or CZP 400 mg Q2W; and had received at least one dose of CZP with up to 144 weeks of exposure. Treatment-emergent adverse events (TEAEs) were classified using MedDRA v18·1. Reported incidence rates (IRs) are incidence of new cases per 100 patient-years (PY).
RESULTS


Over 144 weeks, 995 patients received at least one dose of CZP (exposure: 2231·3 PY); 731 and 728 received at least one dose of CZP 200 mg Q2W (1211·4 PY) and/or 400 mg Q2W (1019·9 PY), respectively. The IR [95% confidence interval (CI)] of TEAEs was 144·9 (135·3-155·0) for all patients, 134·1 (123·2-145·7) for CZP 200 mg Q2W and 158·3 (145·5-171·9) for CZP 400 mg Q2W. The IR (95% CI) of serious TEAEs for all patients was 7·5 (6·4-8·8); the IRs were 6·7 (5·2-8·3) and 8·7 (6·9-10·8) for CZP 200 mg and 400 mg Q2W, respectively. Overall, 3·2% of patients reported serious infections (2·2% within each of the CZP 200 and 400 mg Q2W groups). Overall, there was one case of active tuberculosis, 16 malignancies in 14 patients and seven deaths (two considered treatment-related). The cumulative IR of TEAEs did not increase over time.
CONCLUSIONS


No new safety signals were identified compared with previously reported data. Risk did not increase with longer or higher CZP exposure.",2020,3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups).,"['Plaque Psoriasis', 'Included patients: had moderate to severe PSO ≥6 months', 'adults with plaque psoriasis (PSO', '995 patients received ≥1 dose CZP (exposure: 2,231.3 PY); 731 and 728 received']","['Placebo', 'CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP', 'Certolizumab pegol (CZP', '≥1 dose CZP 200 mg Q2W']","['serious infections', 'Cumulative IR of TEAEs']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",995.0,0.282486,3.2% patients reported serious infections (2.2% within each of the CZP 200 and 400 mg Q2W groups).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'van de Kerkhof', 'Affiliation': 'Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Arendt', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19314']
1113,32533228,Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).,"PURPOSE


To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer.
METHODS


This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H 0 ), and promising if the lower limit of the 95% confidence interval was >45%. If that lower limit was >40%, H 0  was rejected. Secondary objectives included progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity. The study was terminated early after 74 patients; 68 patients were evaluable.
RESULTS


Two-year OS was 71% in arm A (95% CI: 55-87%) vs. 53% in arm B (95% CI: 36-71%); H 0  was rejected. Median OS was 49.1 vs. 24.1 months (p = 0.147). Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21). At 2 years, PFS was 56% vs. 44%, LC 84% vs. 72%, and MFS 74% vs. 54%. HRs were 0.51 (0.25-1.04) for progression, 0.43 (0.13-1.40) for locoregional failure, and 0.43 (0.17-1.05) for distant metastasis. Overall response was 81% vs. 69% (p = 0.262). Twenty-six and 27 patients, respectively, experienced at least one toxicity grade ≥3 (p = 0.573). A significant difference was found for grade ≥3 allergic reactions (12.5% vs. 0%, p = 0.044).
CONCLUSION


Given the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.",2020,Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21).,"['74\xa0patients; 68\xa0patients were evaluable', 'unresectable esophageal cancer']","['cetuximab', 'radiochemotherapy', 'radiochemotherapy plus cetuximab', 'Radiochemotherapy with or without cetuximab']","['PFS', 'Median OS', 'efficacy and toxicity', 'PFS and MFS', 'locoregional failure', 'progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity', '2‑year overall survival (OS', 'Overall response', 'grade ≥3 allergic reactions', 'Hazard ratio (HR) for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.261344,Hazard ratio (HR) for death was 0.60 (95% CI: 0.30-1.21).,"[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Rades', 'Affiliation': 'Department of Radiation Oncology, University of Lübeck, Ratzeburger Allee\xa0160, 23562, Lübeck, Germany. Rades.Dirk@gmx.net.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Bartscht', 'Affiliation': 'Department of Hematology and Oncology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hunold', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiation Oncology, Johannes-Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'König', 'Affiliation': 'Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Debus', 'Affiliation': 'Department of Radiation Oncology, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Belka', 'Affiliation': 'Department of Radiation Oncology, Ludwig-Maximillians University, Munich, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Homann', 'Affiliation': 'Medical Department II, Klinikum Wolfsburg, Wolfsburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Spillner', 'Affiliation': 'Department of Radiation Oncology, Eberhard-Karls University, Tübingen, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Petersen', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuhnt', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Ridwelski', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Karcher-Kilian', 'Affiliation': 'Practice for Gastroenterology, Diabetology, Oncology and Hematology Lübeck, Lübeck, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kranich', 'Affiliation': 'Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg, Germany.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Männikkö', 'Affiliation': 'Pharma Ltd, Turku, Finland.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic Scottsdale, AZ, USA.'}, {'ForeName': 'Annett', 'Initials': 'A', 'LastName': 'Maderer', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': '1st Department of Internal Medicine, Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01646-4']
1114,32538106,Randomised controlled study to compare radiofrequency ablation with minimally invasive ultrasound-guided non-flush ligation and stripping of great saphenous vein in the treatment of varicose veins.,"INTRODUCTION


Flush ligation at the saphenofemoral junction and stripping of the great saphenous vein is being increasingly replaced by endovenous methods such as radiofrequency or endovenous laser ablation for the treatment of varicose veins. These modalities are expensive and not widely available. A minimally invasive ultrasound-guided surgery with non-flush ligation and stripping under local anaesthesia is a cost-effective alternative with similar postoperative outcomes.
MATERIALS AND METHODS


A total of 62 limbs (58 patients) with saphenofemoral junction incompetence underwent clinical evaluation including the CEAP clinical score, the venous clinical severity score, the venous disability score and venous doppler. Patients were randomly assigned to either group A (radiofrequency ablation) or group B (ultrasound-guided non-flush ligation and stripping of the great saphenous vein) for procedures under tumescent anaesthesia and ultrasound guidance. Patients were followed-up on days 7, 30 and 90 to assess primary (obliteration rates) and secondary (venous clinical severity score and venous disability score) outcomes.
RESULTS


Both the groups showed 100% obliteration of the great saphenous vein at day 90. The venous clinical severity and venous disability scores significantly improved from day 0 to day 90 in both groups ( p  = 0.0001). There were no major complications. Group A showed significantly lower minor complications ( p  = 0.001). None required conversation to general anaesthesia.
CONCLUSIONS


The ultrasound-guided non-flush ligation and stripping of the great saphenous vein are as efficacious as radio frequency ablation, with similar obliteration rates, improvement in disability scores and complication profile at a lower cost. It has the potential for wider availability in the community as most surgeons are conversant with the surgical procedure.",2020,Group A showed significantly lower minor complications ( p  = 0.001).,"['A total of 62 limbs (58 patients) with saphenofemoral junction incompetence underwent clinical evaluation including the', 'varicose veins']","['radiofrequency or endovenous laser ablation', 'ultrasound-guided non-flush ligation and stripping of the great saphenous vein', 'group A (radiofrequency ablation) or group B (ultrasound-guided non-flush ligation and stripping of the great saphenous vein) for procedures under tumescent anaesthesia and ultrasound guidance', 'radiofrequency ablation with minimally invasive ultrasound-guided non-flush ligation and stripping of great saphenous vein', 'minimally invasive ultrasound-guided surgery with non-flush ligation and stripping under local anaesthesia']","['venous clinical severity and venous disability scores', 'CEAP clinical score, the venous clinical severity score, the venous disability score and venous doppler', 'disability scores and complication profile', 'primary (obliteration rates) and secondary (venous clinical severity score and venous disability score) outcomes', 'minor complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0447132', 'cui_str': 'Structure of saphenofemoral junction'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}]","[{'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C3888865', 'cui_str': 'Venous Doppler'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026193', 'cui_str': 'Minor'}]",,0.0311134,Group A showed significantly lower minor complications ( p  = 0.001).,"[{'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Sandhya', 'Affiliation': 'Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Mohil', 'Affiliation': 'Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sricharan', 'Affiliation': 'RajaRajeswari Medical College and Hospital, Bangalore, India.'}]",Annals of the Royal College of Surgeons of England,['10.1308/rcsann.2020.0116']
1115,32539121,Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus Arteriosus in Preterm Infants: A Randomized Clinical Trial.,"Importance


Persistent patent ductus arteriosus (PDA) in preterm infants is associated with increased mortality and respiratory morbidities, including bronchopulmonary dysplasia (BPD). Despite recent increasing use of noninterventional approaches, no study to our knowledge has yet directly compared the nonintervention vs pharmacologic treatment for mediating PDA closure for decreasing mortality and preventing BPD.
Objective


To determine the noninferiority of nonintervention vs oral ibuprofen treatment for PDA in decreasing BPD incidence or death in very preterm infants.
Design, Setting, and Participants


A randomized, double-blind, placebo-controlled, noninferiority clinical trial was conducted on preterm infants (gestational age [GA] 23-30 weeks) with hemodynamically significant PDA (ductal size >1.5 mm plus respiratory support) diagnosed between postnatal days 6 and 14. Participants included 383 infants screened between July 24, 2014, and March 15, 2019.
Interventions


Infants were stratified by GA and randomly assigned (1:1) to receive either oral ibuprofen (initial dose of 10 mg/kg followed by a 5-mg/kg dose after 24 hours and a second 5-mg/kg dose after 48 hours) or placebo.
Main Outcomes and Measures


The primary outcome was BPD or death; the secondary outcomes included major morbidities and ductal closure rates. Per-protocol analysis was used.
Results


Among 383 infants screened for participation, 146 infants were randomly assigned, with 72 in the nonintervention and 70 in the ibuprofen treatment group in the final analyses. The PDA closure rate at 1 week after randomization was significantly higher with ibuprofen (11 [34%]) than nonintervention (2 [7%]) in infants at GA 27 to 30 weeks (P = .007); however, the findings were not significant at GA 23 to 26 weeks (ibuprofen, 3 [8%] vs nonintervention, 1 [2%], P = .34). In addition, the ductal closure rates before hospital discharge (ibuprofen, 62 [89%] vs nonintervention, 59 [82%], P = .27) and device closure (ibuprofen, 2 [3%] vs nonintervention, 4 [6%], P = .40) were not significantly different between the 2 groups. The nonintervention approach was noninferior to ibuprofen treatment in terms of BPD incidence or death (nonintervention, 44%; ibuprofen, 50%; 95% CI, -0.11 to 0.22; noninferiority margin -0.2; P = .51). One infant in the ibuprofen arm received oral ibuprofen backup rescue treatment owing to cardiopulmonary compromise refractory to conservative management, and another infant in the ibuprofen group received surgical ligation; none of the infants in the placebo group received backup treatment.
Conclusions and Relevance


Nonintervention showed noninferiority compared with ibuprofen treatment in closing of hemodynamically significant PDA and reduction of BPD or death. The noninferiority of nonintervention over ibuprofen might be attributable to the low efficacy of oral ibuprofen for closing PDA, especially in infants born at 23 to 26 weeks' gestation.
Trial Registration


ClinicalTrials.gov Identifier: NCT02128191.",2020,"Conclusions and Relevance


Nonintervention showed noninferiority compared with ibuprofen treatment in closing of hemodynamically significant PDA and reduction of BPD or death.","['very preterm infants', 'Participants included 383 infants screened between July 24, 2014, and March 15, 2019', '383 infants screened for participation, 146 infants', 'preterm infants', ""infants born at 23 to 26 weeks' gestation"", 'Patent Ductus', 'Preterm Infants', 'preterm infants (gestational age [GA] 23-30 weeks) with hemodynamically significant PDA (ductal size >1.5 mm plus respiratory support) diagnosed between postnatal days 6 and 14']","['surgical ligation', 'Nonintervention vs Oral Ibuprofen', 'nonintervention vs oral ibuprofen', 'ibuprofen', 'oral ibuprofen', 'placebo']","['BPD or death', 'PDA closure rate', 'device closure', 'mortality and respiratory morbidities, including bronchopulmonary dysplasia (BPD', 'BPD incidence or death', 'major morbidities and ductal closure rates', 'ductal closure rates before hospital discharge']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1301752', 'cui_str': 'Respiratory morbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",,0.397656,"Conclusions and Relevance


Nonintervention showed noninferiority compared with ibuprofen treatment in closing of hemodynamically significant PDA and reduction of BPD or death.","[{'ForeName': 'Se In', 'Initials': 'SI', 'LastName': 'Sung', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Statistics and Data Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'So Yoon', 'Initials': 'SY', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yun Sil', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Won Soon', 'Initials': 'WS', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Department of Pediatrics, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.1447']
1116,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
1117,32532581,"Effects of Using an Endotracheal Tube Introducer for Intubation During Mechanical Chest Compressions of a Manikin: Randomized, Prospective, Crossover Study.","BACKGROUND


Airway management methods during out-of-hospital cardiac arrest remain controversial.
OBJECTIVES


This study aimed to compare the impact of using an endotracheal tube introducer with a Macintosh laryngoscope on the first-pass success rates of final-year medical students on a manikin during continuous chest compressions with a mechanical compression device.
METHODS


Fifty-two final-year students of the faculty of medicine performed endotracheal intubations on a manikin using the Macintosh laryngoscope with and without the endotracheal tube introducer during chest compressions. First-pass success rates, the times of endotracheal intubations, the second endotracheal intubation attempt success rates, and the difficulty level of each method according to the participants' perceptions were measured.
RESULTS


First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope. Second endotracheal intubation attempt success rates also did not differ by endotracheal tube introducer use. The usage of an endotracheal tube introducer required significantly longer endotracheal intubation time than using only a Macintosh laryngoscope. The perception of difficulty was significantly lower with endotracheal tube introducer use.
CONCLUSION


The use of an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope is not associated with higher first-pass success rates during mechanical chest compressions in adult simulations performed by final-year medical students. © 2020 Elsevier Inc.",2020,"RESULTS


First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope.",['Fifty-two final-year students of the faculty of'],"['endotracheal tube introducer with a Macintosh laryngoscope', 'medicine performed endotracheal intubations on a manikin using the Macintosh laryngoscope with and without the endotracheal tube introducer during chest compressions', 'endotracheal tube introducer', 'Endotracheal Tube Introducer for Intubation']","['perception of difficulty', 'times of endotracheal intubations, the second endotracheal intubation attempt success rates', 'endotracheal intubation time']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}]","[{'cui': 'C0179390', 'cui_str': 'Bougie'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",,0.0210338,"RESULTS


First-pass success rates did not differ using an endotracheal tube introducer as an adjunct to a Macintosh laryngoscope.","[{'ForeName': 'Asim Enes', 'Initials': 'AE', 'LastName': 'Ozbek', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Huseyin Cahit', 'Initials': 'HC', 'LastName': 'Halhalli', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Emergency Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Celik', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Ozerol', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Şancı', 'Affiliation': 'Department of Emergency Medicine, University of Health Sciences Kocaeli Derince Training and Research Hospital, Kocaeli, Turkey.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.04.056']
1118,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE


Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed.
MATERIALS AND METHODS


Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2  weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2  weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2  biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed.
RESULTS


Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers.
CONCLUSIONS


There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011']
1119,32541299,Design of a Randomized Clinical Trial of Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair (Investigation to Minimize Prolapse Recurrence of the Vagina using Estrogen: IMPROVE).,"OBJECTIVES


To provide the rationale and design for a randomized, double-blind clinical trial of conjugated estrogen vaginal cream (applied for at least 5 weeks preoperatively and continued twice-weekly through 12 months postoperatively) compared with placebo in postmenopausal women with symptomatic pelvic organ prolapse undergoing a standardized transvaginal native tissue apical repair.
METHODS


Study population, randomization process, study cream intervention, masking of participants and evaluators, placebo cream manufacture, standardized surgical intervention, and collection of adverse events are described. The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months. Time-to-failure postoperatively will be compared in the 2 groups with continued surveillance to 36 months. Secondary outcomes assessed at baseline, preoperatively (ie, after at least 5 weeks of study cream), and postoperatively at 6 month intervals include validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image. Challenges unique to this study include design and manufacture of placebo and defining and measuring study drug adherence.
RESULTS


Recruitment of 204 women is complete with 197 randomized. There have been 174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit.
CONCLUSIONS


This trial will contribute evidence-based information regarding the effect of perioperative vaginal estrogen as an adjunct therapy to standardized transvaginal native tissue prolapse surgical repair.",2020,"The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months.","['204 women is complete with 197 randomized', 'postmenopausal women with symptomatic pelvic organ prolapse undergoing a', 'standardized transvaginal native tissue prolapse surgical repair', '174 surgeries completed with 15 more pending; 111 have completed their 12 month postoperative visit']","['Perioperative Vaginal Estrogen Versus Placebo With Transvaginal Native Tissue Apical Prolapse Repair', 'perioperative vaginal estrogen', 'conjugated estrogen vaginal cream', 'standardized transvaginal native tissue apical repair', 'placebo cream manufacture, standardized surgical intervention', 'placebo']","['validated condition-specific and general quality-of-life metrics, overall impression of improvement, sexual function, vaginal atrophy symptoms, and body image', 'surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580703', 'cui_str': 'Postoperative visit'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0241616', 'cui_str': 'Atrophy of vagina'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1550321', 'cui_str': 'Vaginal cuff'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]",204.0,0.688158,"The primary outcome of surgical success is a composite of objectively no prolapse beyond the hymen and the vaginal cuff descending no more than one third the vaginal length; subjectively, no sense of vaginal pressure or bulging; and no retreatment for prolapse at 12 months.","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'From the *Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX †Department of Obstetrics and Gynecology, University of Alabama, Birmingham, AL ‡Department of Obstetrics and Gynecology, Alpert Medical School of Brown University/Women and Infants Hospital of Rhode Island, Providence, RI §Department of Obstetrics and Gynecology, Baylor Scott and White Memorial Hospital, Temple TX ∥Departments of Population and Data Sciences and Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ''}, {'ForeName': 'Wilma I', 'Initials': 'WI', 'LastName': 'Larsen', 'Affiliation': ''}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Hynan', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000899']
1120,32512262,Intensive therapy alleviates subclinical synovitis on ultrasound and disease activity and reduces flare in rheumatoid arthritis patients who have achieved clinical target - a randomized controlled trial.,"OBJECTIVE


Whether intensive therapy can alleviate subclinical synovitis and reduce flare in rheumatoid arthritis (RA) patients in clinical remission remains unclear. We designed a 1-year open-labelled, randomized controlled clinical trial to elucidate this question.
METHODS


RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2] were randomized to receive maintenance or intensive treatment at a ratio of 1:1. The primary outcome was the rate of RA relapse (defined by DAS28-CRP>3.2 and an increase≥0.6). The secondary outcomes were changes of PD and GS scores, and clinical disease activity at each visit from baseline.
RESULTS


108 patients with 54 in each group were enrolled. During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively]. Although GS and PD scores were decreased at 12 months in both groups, the decline was more remarkable in intensive group than in maintenance group. The improvement of clinical disease activity score was only observed in intensive group, not maintenance group. Adverse events were comparable between two groups. Abnormal liver function tests were observed in 24 (22%) patients with 16 from intensive group.
CONCLUSION


Intensive therapy can alleviate subclinical synovitis on ultrasound and clinical disease activity, and prevent relapse in RA patients who have achieved clinical remission or low disease activity, with comparable safety profiles to maintenance therapy.
REGISTRATION NUMBER


ChiCTR2000029279.",2020,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","['rheumatoid arthritis patients who have achieved clinical target ', '24 (22%) patients with 16 from intensive group', 'RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2', '108 patients with 54 in each group were enrolled', 'rheumatoid arthritis']","['Intensive therapy', 'intensive therapy']","['rate of RA relapse', 'Adverse events', 'changes of PD and GS scores, and clinical disease activity', 'GS and PD scores', 'relapse rate', 'clinical disease activity score', 'Abnormal liver function tests']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}]",108.0,0.101084,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China. Electronic address: zhuoli.zhang@126.com.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.014']
1121,32521324,"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.","OBJECTIVE


To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities.
METHODS


Prospective, randomized, controlled, open, 12-month trial (NCT02374749).
PARTICIPANTS


consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group).
MAIN OUTCOME


change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management).
RESULTS


502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
CONCLUSIONS AND RELEVANCE


This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.",2020,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
","['consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM', 'patients with axial spondyloarthritis', '502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y', 'young population of patients with axSpA']","['nurse-led program of systematic screening', 'nurse-led program', 'single-visit nurse-led program']",['weighted comorbidity management score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",502.0,0.0692749,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France. Electronic address: anna.molto@aphp.fr.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, Paris France; Pitié Salpêtrière hospital, APHP, Rheumatology department, Paris, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, F-94010, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, Toulouse, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, Paris, France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.012']
1122,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE


Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD


To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS


Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION


Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
1123,32524499,"PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta ® ): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers.","INTRODUCTION


PF-06881894 is a proposed biosimilar to pegfilgrastim (Neulasta ® ). This study evaluated the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ) in healthy volunteers.
METHODS


A phase 1, open-label, randomized, crossover study was conducted to assess the pharmacologic equivalence and safety of a single 6-mg dose of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU. The primary PD endpoints were area under the effect-versus-time curve for absolute neutrophil count (ANC) from dose administration to 288 h postdose, and maximum observed ANC value among subjects confirmed negative for anti-pegfilgrastim antibodies. Primary PK variables included area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration. A second phase 1, open-label, randomized (1:1), parallel-group, non-inferiority study was conducted to assess the immunogenicity and safety of multiple 6-mg doses of PF-06881894 versus pegfilgrastim-US. The primary endpoint for the immunogenicity study was the proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies at any time during the study.
RESULTS


Across the single- and multiple-dose studies (N = 153 and N = 420 treated subjects, respectively), demographics for age (18-65 years), male gender (n = 264/573), and white race (n = 423/573) were similar. Three-way PD/PK equivalence of PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU was demonstrated with the primary PD endpoints and primary PK variables being completely contained within the predefined 90% confidence interval acceptance limits (80-125%). The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%). Overall, there were no clinically meaningful differences in safety profiles among or between study groups.
CONCLUSIONS


Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT02629289; NCT03273842 (C1221005).",2020,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"['Healthy Volunteers', '420 treated subjects, respectively), demographics for age (18-65\xa0years), male gender (n\u2009=\u2009264/573), and white race (n\u2009=\u2009423/573', 'healthy volunteers']","['PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta ® ', 'pegfilgrastim-US', 'PF-06881894, pegfilgrastim-US, and pegfilgrastim-EU']","['area under the effect-versus-time curve for absolute neutrophil count (ANC', 'pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety', 'proportion of subjects with both negative baseline and confirmed positive postdose anti-pegfilgrastim antibodies', 'area under the serum pegfilgrastim-versus-time curve from the time of dose administration to time infinity and maximum observed serum pegfilgrastim concentration', 'pharmacologic equivalence and safety', 'PD/PK equivalence', 'immunogenicity and safety', 'confidence interval acceptance limits']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C1171279', 'cui_str': 'Neulasta'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",420.0,0.0810477,The non-inferiority of PF-06881894 versus pegfilgrastim-US in terms of immunogenicity was established according to the prespecified non-inferiority margin (≤10%).,"[{'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Moosavi', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Borema', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Ewesuedo', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Quotient Sciences, Miami, FL, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'May', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Summers', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Pfizer Inc, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA.'}, {'ForeName': 'Hsuan-Ming', 'Initials': 'HM', 'LastName': 'Yao', 'Affiliation': 'Pfizer Inc, Lake Forest, IL, USA. hsuan-ming.yao@pfizer.com.'}]",Advances in therapy,['10.1007/s12325-020-01387-x']
1124,32524500,"Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis.","INTRODUCTION


The primary analysis of a global phase 3 study that evaluated the efficacy and safety of denosumab versus zoledronic acid for preventing skeletal-related events (SREs) in adults with newly diagnosed multiple myeloma (MM) indicated that denosumab was noninferior to zoledronic acid for time to first on-study SREs. Here we present a subgroup analysis to evaluate efficacy and safety in Asian patients.
METHODS


Patients were randomized 1:1 to receive denosumab 120 mg subcutaneously or zoledronic acid intravenously 4 mg every 4 weeks in a double-blind, double-dummy fashion. All patients received standard-of-care first-line antimyeloma treatment. Each patient received either study drug until an estimated 676 patients experienced at least one on-study SRE and the primary efficacy and safety analyses were completed.
RESULTS


Of 1718 total enrolled patients, 196 Asian patients (denosumab, n = 103; zoledronic acid, n = 93) were included in this subgroup analysis. Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]). All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE. The most common AEs reported in either group (denosumab, zoledronic acid) were diarrhea (51.0%, 51.1%), nausea (42.2%, 46.7%), and pyrexia (38.2%, 41.3%). Treatment-emergent renal toxicity occurred in 9/102 (8.8%) and 20/92 (21.7%) patients, respectively. Similar rates of positively adjudicated osteonecrosis of the jaw (7 [6.9%] vs 5 [5.4%]) and treatment-emergent hypocalcemia (19 [18.6%] vs 17 [18.5%]) were reported in the denosumab and zoledronic acid groups, respectively.
CONCLUSION


Efficacy and safety outcomes from this Asian subgroup were comparable to those of the full study population. Overall, this analysis supports denosumab as an additional treatment option for standard of care for Asian patients with newly diagnosed MM with lytic bone lesions.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01345019.",2020,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","['Newly Diagnosed Multiple Myeloma', 'adults with newly diagnosed multiple myeloma (MM', 'Asian patients', 'Patients', 'Asian patients with newly diagnosed MM with lytic bone lesions', '1718 total enrolled patients, 196 Asian patients (denosumab, n\u2009=\u2009103; zoledronic acid, n\u2009=\u200993', 'All 194 patients receiving at least one dose of study drug experienced at least one treatment-emergent AE']","['standard-of-care first-line antimyeloma treatment', 'zoledronic acid', 'Denosumab Versus Zoledronic Acid', 'denosumab versus zoledronic acid', 'denosumab 120\xa0mg subcutaneously or zoledronic acid']","['diarrhea', 'skeletal-related events (SREs', 'treatment-emergent hypocalcemia', 'renal toxicity', 'pyrexia', 'efficacy and safety', 'Efficacy and safety outcomes', 'crude incidence of SREs', 'nausea']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0238792', 'cui_str': 'Bone lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",196.0,0.620923,"Fewer patients in the denosumab group developed first on-study SRE compared with the zoledronic acid group; the crude incidence of SREs at the primary analysis cutoff was 38.8% and 50.5%, respectively (HR [95% CI], 0.77 [0.48-1.26]).","[{'ForeName': 'Shang-Yi', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sung-Soo', 'Initials': 'SS', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Wee Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore, National University Health System, Singapore, Republic of Singapore.'}, {'ForeName': 'Cheng-Shyong', 'Initials': 'CS', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.'}, {'ForeName': 'Raymond Siu-Ming', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer and Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Seasea', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Gordon', 'Affiliation': 'Amgen Asia Holding Ltd., Hong Kong SAR, China.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Glennane', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea. ckmin@catholic.ac.kr.""}]",Advances in therapy,['10.1007/s12325-020-01395-x']
1125,32524511,A novel approach to medicines optimisation post-discharge from hospital: pharmacist-led medicines optimisation clinic.,"Background There is a major drive within healthcare to reduce patient readmissions, from patient care and cost perspectives. Pharmacist-led innovations have been demonstrated to enhance patient outcomes. Objective To assess the impact of a post-discharge, pharmacist-led medicines optimisation clinic on readmission parameters. Assessment of the economic, clinical and humanistic outcomes were considered. Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland. Method Randomised, controlled trial. Blinded random sequence generation; a closed envelope-based system, with block randomisation. Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic. Analysis was carried out for intention-to-treat and per-protocol perspectives. Main Outcome Measure 30-day readmission rate. Results Readmission rate reduction at 30 days was 9.6% (P = 0.42) and the reduction in multiple readmissions over 180-days was 29.1% (P = 0.003) for the intention-to-treat group (n = 31) compared to the control group (n = 31). Incidence rate ratio for control patients for emergency department visits was 1.65 (95% CI 1.05-2.57, P = 0.029) compared with the intention-to-treat group. For unplanned GP consultations the equivalent incident rate ratio was 2.00 (95% CI 1.18-3.58, P = 0.02). Benefit to cost ratio in the intention-to-treat and per-protocol groups was 20.72 and 21.85 respectively. Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points. A positive impact was also demonstrated in relation to patient beliefs about their medicines and medication adherence. Conclusion A pharmacist-led post-discharge medicines optimisation clinic was beneficial from a patient care and cost perspective.",2020,"Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.","['Adult patients with acute unplanned admission to medical wards subject to inclusion criteria were invited to attend clinic', 'Setting Respiratory and cardiology wards in a district general hospital in Northern Ireland']",[],"['Readmission rate reduction', 'Patient Health Related Quality of Life', 'multiple readmissions', 'Incidence rate ratio', '30-day readmission rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0730261', 'cui_str': 'Attending clinic'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}]",[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}]",,0.208605,"Patient Health Related Quality of Life was significantly higher at 30-day (P < 0.001), 90-day (P < 0.001) and 180-day (P = 0.036) time points.","[{'ForeName': 'Mohanad', 'Initials': 'M', 'LastName': 'Odeh', 'Affiliation': 'Pharmacy Management and Pharmaceutical Care Innovation Centre, Hashemite University, 13133 Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Scullin', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hogg', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Fleming', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Scott', 'Affiliation': 'Medicines Optimisation Innovation Centre (MOIC), Bretten Hall, Northern Health and Social Care Trust, Antrim Site, Antrim, UK.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'McElnay', 'Affiliation': ""Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, UK. j.mcelnay@qub.ac.uk.""}]",International journal of clinical pharmacy,['10.1007/s11096-020-01059-4']
1126,32531302,Wound eversion versus planar closure for wounds on the face or neck: A randomized split-wound comparative effectiveness trial.,,2020,,['Wounds on the Face or Neck'],['Wound Eversion Versus Planar Closure'],[],"[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.024742,,"[{'ForeName': 'Claire C', 'Initials': 'CC', 'LastName': 'Alexanian', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California; Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Zhuang', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California.'}, {'ForeName': 'Milene K', 'Initials': 'MK', 'LastName': 'Crispin', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Eisen', 'Affiliation': 'Department of Dermatology, University of California, Davis, Sacramento, California. Electronic address: deisen123@gmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.013']
1127,32533948,Corneal Topography Raw Data Classification Using a Convolutional Neural Network.,"PURPOSE


We investigated the efficiency of a convolutional neural network applied to corneal topography raw data to classify examinations of 3 categories: normal, keratoconus (KC), and history of refractive surgery (RS).
DESIGN


Retrospective machine-learning experimental study.
METHODS


A total of 3,000 Orbscan examinations (1,000 of each class) of different patients of our institution were selected for model training and validation. One hundred examinations of each class were randomly assigned to the test set. For each examination, the raw numerical data from ""elevation against the anterior best fit sphere (BFS),"" ""elevation against the posterior BFS"" ""axial anterior curvature,"" and ""pachymetry"" maps were used. Each map was a square matrix of 2,500 values. The 4 maps were stacked and used as if they were 4 channels of a single image.A convolutional neural network was built and trained on the training set. Classification accuracy and class wise sensitivity and specificity were calculated for the validation set.
RESULTS


Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%). Sensitivity and specificity were, respectively, 100% and 100% for KC, 100% and 99% (94.9%-100%) for normal examinations, and 98% (97.4%-100%) and 100% for RS examinations.
CONCLUSION


Using combined corneal topography raw data with a convolutional neural network is an effective way to classify examinations and probably the most thorough way to automatically analyze corneal topography. It should be considered for other routine tasks performed on corneal topography, such as refractive surgery screening.",2020,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"['3,000 Orbscan examinations (1000 of each class) of different patients of our institution were selected for model training and validation', '100 examinations of each class']",[],"['Classification accuracy and class wise sensitivity and specificity', 'Sensitivity and specificity']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],"[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",,0.0443956,Overall classification accuracy of the validation set (n = 300) was 99.3% (98.3%-100%):.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Zéboulon', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France. Electronic address: pierrezeboulon@gmail.com.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Debellemanière', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Magalie', 'Initials': 'M', 'LastName': 'Bouvet', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gatinel', 'Affiliation': 'Department of Ophthalmology, Rothschild Foundation, Paris, France; CEROC (Center of Expertise and Research in Optics for Clinicians), Paris, France.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.005']
1128,32540150,Sleeve gastrectomy and Roux-en-Y gastric bypass in the treatment of type 2 diabetes. Two-year results from a Swedish multicenter randomized controlled trial.,"BACKGROUND


Obesity is a world-wide epidemic and it is a risk factor for type 2 diabetes (T2D). Few randomized controlled studies have compared the 2 most common surgical procedures, Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in the treatment of obese patients with T2D.
OBJECTIVES


To compare diabetes remission rates (glycosylated hemoglobin ≤6.0%, without diabetes medications) in obese T2D patients (body mass index, 35-50) undergoing RYGB or SG.
SETTING


Three University Hospital clinics and 1 Regional Hospital in Sweden.
METHODS


Forty-nine patients with T2D were included. Twenty-five were randomized to RYGB and 24 to SG. There was no difference between groups regarding patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels. All patients (100%) completed 1-year follow-up and 47 (95.9%) 2-year follow-up.
RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up. Similarly, mean glycosylated hemoglobin was improved in both groups at 1 and 2 years, with no significant differences between the groups (RYGB baseline versus 1 yr; mean ± standard deviation: 7.9 ± 1.5 versus 5.8 ± .6%, P < .0001; versus 2 yr: 5.9 ± .7%, P < .0001; SG baseline versus 1 yr: 8.2 ± 1.9 versus 5.9 ± .7%, P < .0001; versus 2 yr: 5.9 ± 1.1%, P < .0001). Total weight loss was not different but percentage excess weight loss was higher after RYGB compared with SG both at 1 and 2 years; mean ± standard deviation: 78 ± 22 versus 60 ± 22%, and 76 ± 24 versus 54 ± 21%, respectively (P < .01 for both). Waist circumference also decreased significantly more in the RYGB group.
CONCLUSIONS


Despite superior excess weight loss after RYGB, T2D remission rates did not differ significantly between RYGB and SG after 2 years. Long-term follow-up data are needed to define the role of SG in the treatment of patients with obesity and T2D.",2020,"RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up.","['patients with obesity and T2D', 'obese patients with T2D', 'obese T2D patients (body mass index, 35-50) undergoing RYGB or SG', 'Forty-nine patients with T2D were included', 'Twenty-five were randomized to RYGB and 24 to SG', 'type 2 diabetes', 'Three University Hospital clinics and 1 Regional Hospital in Sweden']","['Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG', 'Sleeve gastrectomy and Roux-en-Y gastric bypass']","['Waist circumference', 'Total weight loss', 'T2D remission rates', 'mean glycosylated hemoglobin', 'patient characteristics, duration of T2D, overall usage of antidiabetic medications, or glycosylated hemoglobin levels', 'Remission of T2D', 'diabetes remission rates', 'weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",49.0,0.0638498,"RESULTS


Remission of T2D was not significantly different between the RYGB and SG, reaching 44% and 46% (n = 25 and n = 24, respectively, P = .897, power = .80) at 1 year, and 48% and 55% (n = 25 and n = 22, respectively, P = .654) at 2 years of follow-up.","[{'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Wallenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital Östra, University of Gothenburg, Gothenburg, Sweden. Electronic address: ville.wallenius@gastro.gu.se.'}, {'ForeName': 'Aiham', 'Initials': 'A', 'LastName': 'Alaraj', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Björnfot', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Orrenius', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kylebäck', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Björklund', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital Östra, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Werling', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Thorell', 'Affiliation': 'Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden; Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fändriks', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Almantas', 'Initials': 'A', 'LastName': 'Maleckas', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.04.033']
1129,32524827,An integrated videoconferencing intervention for chronic pain and heavy drinking among patients in HIV-care: a proof-of-concept study.,"Chronic pain and heavy drinking are common comorbid conditions among people living with HIV/AIDS (PLWHA). An integrated approach to address these co-occurring conditions in a manner that facilitates treatment utilization would represent an important advance in HIV-care. This study examined the acceptability and feasibility of a tailored, videoconferencing intervention to reduce chronic pain and heavy drinking among PLWHA. Participants in HIV-care (n = 8) completed baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions. Acceptability and feasibility were assessed with patient satisfaction ratings and interview responses 8 weeks following baseline along with videoconferencing use during the intervention period. Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format. All participants successfully enabled videoconferencing on their own smartphones and completed a median number of 4.5 (out of 6) video-sessions. Changes in heavy drinking and pain provided additional support for the potential utility of this approach. Results suggest that this videoconferencing intervention is an acceptable and feasible method of addressing chronic pain and heavy drinking among PLWHA. Findings provide the basis for future work to examine the efficacy of this approach in a Stage 1b trial.",2020,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","['patients in HIV-care', 'Participants in HIV-care (n\u2009=\u20098) completed', 'people living with HIV/AIDS (PLWHA']","['integrated videoconferencing intervention', 'baseline assessments and an in-person intervention session followed by 6 videoconferencing sessions', 'videoconferencing intervention']","['Acceptability and feasibility', 'chronic pain and heavy drinking', 'Chronic pain and heavy drinking', 'Treatment satisfaction and comprehensibility ratings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0421099,"Treatment satisfaction and comprehensibility ratings were high and supported by interview responses indicating the value of the intervention content, treatment alliance, and format.","[{'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Maya P L', 'Initials': 'MPL', 'LastName': 'Kratzer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston Medical Center and Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Otis', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA.'}]",AIDS care,['10.1080/09540121.2020.1776825']
1130,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803']
1131,32532700,The Hunger Games: Laparoscopic Performance in Novice Surgeons is Not Altered by Food Deprivation but Influenced by the Degree of Appetite - A Randomized Controlled Trial.,"OBJECTIVES


Food deprivation is a common condition for visceral surgeons and especially laparoscopic approaches require high levels of concentration. The current literature does not provide adequate answers whether intraoperative breaks, especially food intake, might influence the quality of the surgical skills. Thus, the primary aim of this trial was to analyze the influence of food deprivation on the laparoscopic performance.
DESIGN SETTING AND PARTICIPANTS


37 laparoscopic novices participated from 10/2017 to 04/2018 in this single center, prospective-randomized trial and were trained during laparoscopic training sessions until they reached a predefined level of proficiency. Subsequently, participants were randomized into 3 different groups: food deprivation of 8 hours, 4 hours, or carbohydrate loading directly prior to the laparoscopic exam. The exam comprised PEG-transfer, precise cutting, gallbladder resection and surgical knot.
MAIN FINDINGS


Completion time for PEG-transfer, precise cutting, gallbladder resection and surgical knot was 63s, 139s, 192s and 272s respectively. Participants starving for 8 hours performed 3 of 4 tasks more slowly whilst participants starving for 4 hours performed 3 of 4 tasks faster than the average. Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s). Additionally, hungry students had been more inaccurate during the surgical knot (p <0.05) whilst students with intermediate appetite level tend to be most accurate (p - value 0.012).
CONCLUSIONS


The subjective level of appetite rather than the absolute number of fasting hours influences the laparoscopic performance most. Thus, any extreme level of appetite may be avoided and surgeons may achieve the best performance when they have an intermediate level of appetite. In consequence, heavy meals may be omitted immediately prior to demanding laparoscopic procedures and surgeons may have access to mini-breaks and refreshers during major procedures.",2020,Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s).,['37 laparoscopic novices participated from 10/2017 to 04/2018 in this single center'],"['laparoscopic training sessions', 'food deprivation of 8 hours, 4 hours, or carbohydrate loading directly prior to the laparoscopic exam']","['Completion time for PEG-transfer, precise cutting, gallbladder resection and surgical knot']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0016464', 'cui_str': 'Food Deprivation'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C4277655', 'cui_str': 'Carbohydrate Loading Diet'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0560032', 'cui_str': 'knot'}]",37.0,0.0776599,Analyzing self-reported level of appetite revealed: Students with an intermediate level were significantly faster (p <0.05) during complex procedures compared to participants that reported hunger prior to performing these tasks (192s vs. 307s).,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Bechtolsheim', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Oehme', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Weitz', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Oppermann', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Reissfelder', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of Surgery, University Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Soeren T', 'Initials': 'ST', 'LastName': 'Mees', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of General, Visceral, and Thoracic Surgery, Municipal Hospital Dresden-Friedrichstadt, Dresden, Germany.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery, University Hospital Dresden, Dresden, Germany; Department of Surgery, University Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: cui.yang@umm.de.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.03.029']
1132,32682995,The impact of narratives and active video games on long-term moderate-to-vigorous physical activity: A randomized controlled trial protocol.,"BACKGROUND


Although physical activity (PA) has been shown in helping prevent and treat obesity, current PA interventions are still not effective in ameliorating the obesity epidemic. Additional forms of PA need to be investigated to improve PA engagement and outcomes. We hypothesize that pairing a narrative (i.e., story) with an active video game (AVG), a less traditional form of PA, will increase participant engagement in PA. This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes.
OBJECTIVE


This paper presents the rationale, implementation, and pilot results of a study assessing the effect of narrative's impact on PA and a series of other health outcomes.
METHODS/DESIGN


The Active Video Game Study is a six-month randomized controlled single-blind trial projected to include 210 participants. The intervention strategy will pair a narrative to an active video game (AVG). Participants will be randomized into 3 groups: condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control]. Participants will undergo three in-person data collection visits over the course of six months. Inclusion criteria are that children are between the ages of 8-12 and have a BMI ≥ 85%. The primary outcome is change in moderate to vigorous physical activity (MVPA). Secondary outcome measures include change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function. A pilot trial of n = 6 was conducted to help develop procedures and address problems that could arise in the main trial.
DISCUSSION


Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.",2020,Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.,"['210 participants', 'long-term moderate-to-vigorous physical activity']","['physical activity (PA', 'narratives and active video games', 'condition A [Narrative + AVG], condition B [AVG Only], and condition C [Control']","['change in moderate to vigorous physical activity (MVPA', 'change in BMI percentile, fasting insulin and glucose, lipid panel, C-reactive protein, and cognitive function']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",210.0,0.130661,Successful completion of this study will provide the empirical basis for novel intervention and design strategies to enhance the impact of AVGs on long-term MVPA.,"[{'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Alon', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': 'Distinguished Emeritus Professor, Baylor College of Medicine, 1100 Bates St, Houston, TX 77030, United States.'}, {'ForeName': 'Tiago V', 'Initials': 'TV', 'LastName': 'Barreira', 'Affiliation': 'Exercise Science Department, Syracuse University, 820 Comstock Ave, Syracuse, NY 13244, United States.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Cabrera-Perez', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Chiu', 'Affiliation': 'Harvard Medical School, Primary Care Martha Eliot, 75 Bickford St, Jamaica Plain, MA 02478, United States.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Fernandez', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fleischman', 'Affiliation': ""Harvard Medical School, Optimal Wellness for Life Clinic, Boston Children's Hospital, Boston, MA 02115, United States.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Floating Hospital for Children at Tufts Medical Center, Boston, MA 02111, United States.'}, {'ForeName': 'Jungyun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Medicine, Stanford University Medical Center, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Melanie C', 'Initials': 'MC', 'LastName': 'Green', 'Affiliation': 'Department of Communication, University at Buffalo, 359 Baldy Hall, Buffalo, NY 14260, United States.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02215, United States.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lessard', 'Affiliation': ""Research Division, Joslin Diabetes Center, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02215, United States.""}, {'ForeName': 'Lynne L', 'Initials': 'LL', 'LastName': 'Levitsky', 'Affiliation': 'Pediatric Endocrinology, Massachusetts General Hospital, Pediatrics, Harvard Medical School, 175 Cambridge St 5(th) Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Misawa', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Noubary', 'Affiliation': 'Department of Health Sciences, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Samuels', 'Affiliation': ""Children's Hospital Primary Care Center, Boston Children's Hospital, 300 Longwood Ave, Boston, MA 02115, United States.""}, {'ForeName': 'Kyung Jin', 'Initials': 'KJ', 'LastName': 'Sun', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, 1100 Bates Avenue, Houston, TX 77030, United States.""}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Lu', 'Affiliation': 'Health Technology Lab, College of Arts, Media, and Design, Bouvé College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA 02115, United States. Electronic address: a.lu@northeastern.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106087']
1133,32549208,Evaluation of Sleep Quality in a Disaster Evacuee Environment.,"We aimed to evaluate sleep and sleep-related physiological parameters (heart rate variability and glucose dynamics) among evacuees by experimentally recreating the sleep environment of evacuation shelters and cars. Nine healthy young male subjects participated in this study. Two interventions, modeling the sleep environments of evacuation shelters (evacuation shelter trial) and car seats (car trial), were compared with sleep at home (control trial). Physiological data were measured using portable two-channel electroencephalogram and electrooculogram monitoring systems, wearable heart rate sensors, and flash glucose monitors. Wake after sleep onset (WASO) and stage shift were greater in both intervention trials than the control trial, while rapid-eye movement (REM) latency and non-rapid eye movement (NREM) 1 were longer and REM duration was shorter in the evacuation shelter trial than the control trial. Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial. It was confirmed that sleep environment was important to maintain sleep, and affected glucose dynamics and heart rate variability in the experimental situation.",2020,Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial.,"['Nine healthy young male subjects', 'evacuees by experimentally recreating the sleep environment of evacuation shelters and cars']",[],"['glucose dynamics and heart rate variability', 'Glucose dynamics and power at low frequency (LF.p) of heart rate variability', 'REM duration', 'rapid-eye movement (REM) latency and non-rapid eye movement (NREM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C3178959', 'cui_str': 'Evacuation Shelter'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}]",[],"[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}]",9.0,0.0882766,Glucose dynamics and power at low frequency (LF.p) of heart rate variability were higher in the car trial than in the control trial.,"[{'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Momoko', 'Initials': 'M', 'LastName': 'Kayaba', 'Affiliation': 'Department of Somnology, Tokyo Medical University, Tokyo 160-0023, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Kaneko', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Osaka 565-8531, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima 739-8521, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kiyono', 'Affiliation': 'Graduate School of Engineering Science, Osaka University, Osaka 565-8531, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17124252']
1134,32532687,Mild Inflammation in Healthy Males Induces Fatigue Mediated by Changes in Effective Connectivity Within the Insula.,"BACKGROUND


Systemic inflammation is associated with sickness behaviors such as low mood and fatigue. Activity patterns within the insula are suggested to coordinate these behaviors but have not been modeled. We hypothesized that mild systemic inflammation would result in changes in effective connectivity between the viscerosensory and the visceromotor regions of the insula.
METHODS


We used a double-blind, crossover design to randomize 20 male subjects to receive either a Salmonella typhi vaccine or a placebo saline injection at two separate sessions. All participants underwent a resting-state functional magnetic resonance scan 3 hours after injection. We determined behavioral and inflammatory changes, using the Profile of Mood States questionnaire and interleukin-6 levels. We extracted effective connectivity matrices between bilateral mid/posterior (viscerosensory) and anterior (visceromotor) insular cortices using spectral dynamic causal modeling. We applied parametric empirical Bayes and mediation analysis to determine a vaccination effect on effective connectivity and whether this mediated behavioral changes.
RESULTS


The vaccine condition was associated with greater interleukin-6 levels and greater fatigue 3 hours after the injection. Activity within the right mid/posterior insula increased the activity within the bilateral anterior insular regions. This connectivity was augmented by vaccination over a 99% posterior confidence threshold. The right mid/posterior insula-to-left anterior insula connectivity was significantly associated with fatigue and mediated the association between inflammation and increased fatigue scores.
CONCLUSIONS


These results demonstrate that increased effective connectivity between specific nodes of the insula can model and mediate the association between inflammation and fatigue in males.",2020,Activity within the right mid/posterior insula increased the activity within the bilateral anterior insular regions.,"['20 male subjects', 'Healthy Males']",['Salmonella typhi vaccine or a placebo saline injection'],"['interleukin-6 levels', 'Mood States questionnaire and interleukin-6 levels', 'fatigue scores', 'Mild Inflammation']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0036125', 'cui_str': 'Salmonella Typhi'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522567', 'cui_str': 'Mild inflammation'}]",20.0,0.215377,Activity within the right mid/posterior insula increased the activity within the bilateral anterior insular regions.,"[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Stefanov', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom. Electronic address: kristian.stefanov@glasgow.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McLean', 'Affiliation': 'Institute for Neurological Sciences, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McColl', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Basu', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cavanagh', 'Affiliation': 'Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, United Kingdom; Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Krishnadas', 'Affiliation': 'Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, United Kingdom. Electronic address: rajeev.krishnadas@glasgow.ac.uk.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2020.04.005']
1135,32538535,What have we learned about how to prevent and treat antibody-mediated rejection in kidney transplantation?,"Antibody-mediated rejection (ABMR) in kidney transplantation is a major cause of late graft loss, and despite all efforts to date the ""standard of care"" remains plasmapheresis, IVIg, and steroids, which itself is based on low quality evidence. This review focuses on the risk factors leading to memory and de novo donor-specific antibody (DSA)-associated ABMR, the optimal prevention strategies for ABMR, and advances in  adjunctive and emerging therapies for ABMR. Because new agents require regulatory approval via a Phase 3 randomized control trial (RCT), an overview of progress in innovative trial design for ABMR is provided. Finally, based on the insights gained in the biology of ABMR, current knowledge gaps are identified for future research that could significantly affect our understanding of how to optimally treat ABMR.",2020,"This review focuses on the risk factors leading to memory and de novo donor-specific antibody (DSA)-associated ABMR, the optimal prevention strategies for ABMR, and advances in  adjunctive and emerging therapies for ABMR.",[],['Antibody-mediated rejection (ABMR'],[],[],"[{'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}]",[],,0.0232235,"This review focuses on the risk factors leading to memory and de novo donor-specific antibody (DSA)-associated ABMR, the optimal prevention strategies for ABMR, and advances in  adjunctive and emerging therapies for ABMR.","[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Nickerson', 'Affiliation': 'Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15859']
1136,32540553,Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM).,"BACKGROUND


The combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC.
Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.
RESULTS


Sixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.
CONCLUSIONS


Combination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.",2020,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","['Patients at first relapse or with synchronous metastasis', 'HER-2 positive advanced breast cancer', 'HER-2 positive advanced breast cancer (ABC) therapy', 'Sixty patients with measurable ABC, tumors scored as\xa0+3 for HER-2 or FISH\xa0+, untreated for advanced disease were enrolled', 'Fifteen patients had SD (25']","['trastuzumab', 'cyclophosphamide', 'chemotherapy plus anti HER-2 agents', 'trastuzumab and metronomic capecitabine/cyclophosphamide (HEX', 'trastuzumab and metronomic oral chemotherapy', 'oral capecitabine', 'Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX']","['Median PFS', 'grade 2 nausea', 'Median OS', 'Worst toxicities', 'grade 3 anaemia', 'ORR', 'objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR\xa0+\xa0CR\xa0+\xa0SD for\xa0≥\xa024 weeks) and tolerability', 'Cardiac toxicity grade 1', 'tolerability', 'Median number of cycles', 'visceral metastases', 'grade 3-4 diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0419073', 'cui_str': 'Oral chemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",9.0,0.0480206,"ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Orlando', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy. Electronic address: laura.orlando68@gmail.com.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Lorusso', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giotta', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin at Ordine Mauriziano Hospital, Turin, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Schiavone', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Palma', 'Initials': 'P', 'LastName': 'Fedele', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Quaranta', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caliolo', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Ciccarese', 'Affiliation': 'Medical Oncology, Ospedale Vito Fazzi, Lecce, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Cinefra', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}, {'ForeName': 'Sante', 'Initials': 'S', 'LastName': 'Romito', 'Affiliation': 'Medical Oncology, Ospedali Riuniti, Foggia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Pisconti', 'Affiliation': 'Medical Oncology, Ospedale Moscato, Taranto, Italy.'}, {'ForeName': 'Salvatore Del', 'Initials': 'SD', 'LastName': 'Prete', 'Affiliation': 'Medical Oncology, Ospedale San Giovanni di Dio, Frattamaggiore, Napoli, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Aieta', 'Affiliation': 'Medical Oncology, Ospedale Oncologico Regionale, Rionero in Vulture, Potenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rizzi', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Evaristo', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology, Ospedale Sollievo Della Sofferenza, IRCCS, San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Medical Oncology, Istituto Tumori Giovanni Paolo II, IRCCS, Bari, Italy.'}, {'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Cinieri', 'Affiliation': 'Medical Oncology, Antonio Perrino Hospital, Brindisi, Italy.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.002']
1137,32542356,SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke: A Randomized Controlled Trial.,"OBJECTIVE


Trunk training after stroke is an effective method for improving mobility, yet underlying associations leading to the observed mobility carryover effects are unknown. The purposes of this study were to investigate the effectiveness of trunk training for gait and trunk kinematics and to find explanatory variables for the mobility carryover effects.
METHODS


This study was an assessor-masked, randomized controlled trial. Participants received either additional trunk training (n = 19) or cognitive training (n = 20) after subacute stroke. Outcome measures were the Tinetti Performance-Oriented Mobility Assessment (POMA), the Trunk Impairment Scale, spatiotemporal gait parameters, center-of-mass excursions, and trunk and lower limb kinematics during walking. Multivariate analysis with post hoc analysis was performed to observe treatment effects. Correlation and an exploratory regression analysis were used to examine associations with the mobility carryover effects.
RESULTS


Significant improvements after trunk training, compared with the findings for the control group, were found for the Trunk Impairment Scale, Tinetti POMA, walking speed, step length, step width, horizontal/vertical center-of-mass excursions, and trunk kinematics. No significant differences were observed in lower limb kinematics. Anteroposterior excursions of the trunk were associated with 30% of the variability in the mobility carryover effects.
CONCLUSIONS


Carryover effects of trunk control were present during ambulation. Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale. However, the implementation and generalizability of this treatment approach in a clinical setting are laborious and limited, necessitating further research.
IMPACT


Trunk training is an effective strategy for improving mobility after stroke. Regaining trunk control should be considered an important treatment goal early after stroke to adequately prepare patients for walking.",2020,Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale.,[],"['Trunk Training', 'trunk training', 'SWEAT2', 'IMPACT\n\n\nTrunk training', 'additional trunk training (n\xa0=\xa019) or cognitive training']","['Trunk Impairment Scale, Tinetti POMA, walking speed, step length, step width, horizontal/vertical center-of-mass excursions, and trunk kinematics', 'lower limb kinematics', 'Tinetti POMA Gait subscale', 'Gait and Trunk Kinematics', 'Tinetti Performance-Oriented Mobility Assessment (POMA), the Trunk Impairment Scale, spatiotemporal gait parameters, center-of-mass excursions, and trunk and lower limb kinematics during walking']",[],"[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2317515', 'cui_str': 'Assessment of mobility'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0333277,Decreased anteroposterior movements of the thorax were the main variable explaining higher scores on the Tinetti POMA Gait subscale.,"[{'ForeName': 'Tamaya', 'Initials': 'T', 'LastName': 'Van Criekinge', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI, Universiteitsplein 1, Wilrijk, 2610 Belgium; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hallemans', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Herssens', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lafosse', 'Affiliation': 'RevArte Rehabilitation Hospital, Edegem, Antwerp, Belgium; and Department of Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Claes', 'Affiliation': 'RevArte Rehabilitation Hospital.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'De Hertogh', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Truijen', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Saeys', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Science, University of Antwerp, MOVANT/REVAKI; RevArte Rehabilitation Hospital; and Multidisciplinary Motor Centre Antwerp (M2OCEAN), University of Antwerp.'}]",Physical therapy,['10.1093/ptj/pzaa110']
1138,32546834,A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy.,"BACKGROUND


Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA).
METHODS


A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA.
RESULTS


Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
CONCLUSION


DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number NCT03097653.",2020,"Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
","['Two thousand one hundred and nineteen women were randomised and 1001 completed the study', 'six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB']",['web-based dynamic decision aid (DA'],"['percentage of women attending screening', 'participation rate, satisfaction, decisional conflict, and acceptability of DA', 'Decisional conflict', 'informed choice measured on knowledge, attitudes, and intentions']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",2119.0,0.168763,"Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Roberto', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Candiani', 'Affiliation': 'Zadig, Agenzia di Editoria Scientifica, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Satolli', 'Affiliation': 'Zadig, Agenzia di Editoria Scientifica, Milano, Italy.'}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Giordano', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Jaramillo', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Castagno', 'Affiliation': 'SSD Epidemiologia e Screening - CPO Piemonte - AOU Città della Salute e della Scienza, Torino, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mantellini', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Falini', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carnesciali', 'Affiliation': 'SC Screening e Prevenzione Secondaria, Istituto per lo Studio, la Prevenzione e la Rete Oncologica - ISPRO, Firenze, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Valenza', 'Affiliation': 'UO Centro Gestionale Screening, ASP di Palermo, Palermo, Italy.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Costa', 'Affiliation': 'U.O.S. Screening Mammografico, ASP di Palermo, Palermo, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Campari', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Caroli', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Roberto Cosimo', 'Initials': 'RC', 'LastName': 'Faggiano', 'Affiliation': 'S.S. Screening Oncologici - Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Orione', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Belmessieri', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Marchiò', 'Affiliation': 'Centro Screening Cuneo, ASL CN1, Cuneo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Deandrea', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silvestri', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Luciano', 'Affiliation': 'UOC Medicina Preventiva delle Comunità - Screening, ATS della Città Metropolitana di Milano, Milano, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Paci', 'Affiliation': 'Lega Italiana per la Lotta contro i Tumori, Sezione Firenze, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mosconi', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy. paola.mosconi@marionegri.it.'}]",British journal of cancer,['10.1038/s41416-020-0935-2']
1139,32557133,"Persistent Barriers to Smoking Cessation Among Urban, Underserved Women: A Feasibility Study of Tailored Barriers Text Messages.","OBJECTIVES


Despite health risks for themselves and their children, urban underserved women smoke at high rates postpartum. The postpartum period is a stressful transition time that presents unique barriers to sustained cessation. There is limited extant evidence of efficacious psychosocial programs to maintain postpartum smoking cessation.
METHODS


Guided by the Cognitive-Social Health Information Processing model, we explored the feasibility of TxT2Commit, a text-messaging intervention designed to prevent postpartum smoking relapse. Participants (n = 43) received supportive cessation-focused text messages for one month postpartum. Using a convergent mixed method design, surveys and interviews assessed changes in psychosocial factors and smoking status through a three month follow-up.
RESULTS


Participants reported satisfaction with TxT2Commit, rating text messages as helpful, understandable, supportive, and not bothersome. However, a majority of women (n = 28, 65.1%) relapsed by three months. Participants who stayed smoke free (i.e., non-relapsers) reported significantly less temptation to smoke at one and three months postpartum compared to relapsers (ps < .01). While relapsers had significantly less temptation at one month compared to baseline, temptation increased by three months (p < .01). Consistent with the quantitative results, qualitative interviews identified informational and coping needs, with continued temptation throughout the three months. Non-relapsers were able to manage temptation and reported greater support.
CONCLUSIONS FOR PRACTICE


TxT2Commit demonstrates preliminary feasibility and acceptability among urban, underserved postpartum women. However, most participants relapsed by three months postpartum. Additional research is needed to identify targeted messaging to best help women avoid temptation and bolster support to stay smoke free in this uniquely stressful period.",2020,"While relapsers had significantly less temptation at one month compared to baseline, temptation increased by three months (p < .01).","['urban underserved women smoke at high rates postpartum', 'urban, underserved postpartum women', 'Urban, Underserved Women']","['Smoking Cessation', 'supportive cessation-focused text messages for one month postpartum']","['postpartum smoking relapse', 'psychosocial factors and smoking status', 'temptation to smoke', 'satisfaction with TxT2Commit, rating text messages as helpful, understandable, supportive, and not bothersome']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",,0.0255218,"While relapsers had significantly less temptation at one month compared to baseline, temptation increased by three months (p < .01).","[{'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Tagai', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Miller', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA. Suzanne.Miller@fccc.edu.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Belfiglio', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Wen', 'Affiliation': 'Cancer Prevention and Control, Fox Chase Cancer Center/Temple University Health System, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hernandez', 'Affiliation': 'Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine, Temple University, 3500 N. Broad Street, Philadelphia, PA, 19410, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02963-x']
1140,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE


Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D.
SUBJECTS/METHODS


Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction.
RESULTS


After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
CONCLUSIONS


Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020).
","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571']
1141,32552310,A randomised phase II trial testing the acceptability and feasibility of a narrative approach to public health communication to increase community engagement with palliative care.,"BACKGROUND


Communities have limited understanding of palliative care, creating barriers to informed choice around consideration of a full range of care options in the event of serious illness. Few empirically tested interventions are available to educate community about palliative care, and ultimately improve timely access to these services.
AIM


To test the acceptability (primary outcome), and feasibility of a narrative approach to public health communication seeking to improve attitudes to possible access to palliative care in the event of serious illness.
DESIGN


Randomised phase II trial with six parallel experimental conditions. Outcomes tested included measures of acceptability, feasibility and change in attitudes to possible access to palliative care post-intervention. Contrasts planned for exploratory testing included format, message content and narrator.
SETTING/PARTICIPANTS


Community-based sample of consecutive English-speaking adults who volunteered their participation in response to a study advertisement distributed online through established community groups.
RESULTS


A narrative approach to public health communication was found to be acceptable to community members, and feasible to deliver online. Exploratory data suggested it immediately improved attitudes towards possible access to palliative care in the event of serious illness, with the narrative detailing a description of the evidence delivered by a healthcare professional appearing to be the most promising strategy.
CONCLUSIONS


This study provides preliminary data to inform a future, longitudinal trial evaluating effectiveness and ultimately other evidence-based, public health approaches to improve community engagement with palliative care. Further studies are required to confirm the generalisability of findings to a broader representative sample and other settings including internationally.",2020,"Exploratory data suggested it immediately improved attitudes towards possible access to palliative care in the event of serious illness, with the narrative detailing a description of the evidence delivered by a healthcare professional appearing to be the most promising strategy.
",['Community-based sample of consecutive English-speaking adults who volunteered their participation in response to a study advertisement distributed online through established community groups'],"['narrative approach to public health communication seeking', 'narrative approach to public health communication']","['acceptability, feasibility and change in attitudes to possible access to palliative care post-intervention']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",6.0,0.0851889,"Exploratory data suggested it immediately improved attitudes towards possible access to palliative care in the event of serious illness, with the narrative detailing a description of the evidence delivered by a healthcare professional appearing to be the most promising strategy.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': ""Department of Medicine, St Vincent's Hospital, The University of Melbourne, Fitzroy, VIC, Australia.""}, {'ForeName': 'Sue-Anne', 'Initials': 'SA', 'LastName': 'McLachlan', 'Affiliation': ""Medical Oncology, St Vincent's Hospital Melbourne, Fitzroy, VIC, Australia.""}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Moonshine Agency, Cremorne, VIC, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'Moonshine Agency, Cremorne, VIC, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': ""Department of Medicine, St Vincent's Hospital, The University of Melbourne, Fitzroy, VIC, Australia.""}]",Palliative medicine,['10.1177/0269216320932766']
1142,32556156,Vision-Related Functioning in Patients Undergoing Pneumatic Retinopexy vs Vitrectomy for Primary Rhegmatogenous Retinal Detachment: A Post Hoc Exploratory Analysis of the PIVOT Randomized Clinical Trial.,"Importance


Although rhegmatogenous retinal detachment (RRD) repair techniques have high anatomical reattachment rates, there may be differences in various aspects of postoperative vision-related quality of life (VRQoL).
Objective


To explore the differences in various aspects of VRQoL between pneumatic retinopexy (PnR) and pars plana vitrectomy (PPV) following RRD repair.
Design, Setting, and Participants


Post hoc exploratory analysis of the the Pneumatic Retinopexy vs Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes randomized clinical trial conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada. Patients with RRD with a single break or multiple breaks within 1 clock hour of detached retina in the superior 8 clock hours of the retina with any number, location, and size of retinal breaks or lattice degeneration in attached retina.
Main Outcomes and Measures


Differences in the 25-Item National Eye Institute Visual Function Questionnaire 12 subscale scores between the PnR and PPV groups at 6 months following RRD repair.
Results


A total of 160 patients were included in this analysis, with 81 patients (92%) and 79 patients (90%) in the PnR and PPV groups, respectively. The PnR group consisted of 32% women with a mean (SD) age of 60.9 (9.3) years, while the PPV group consisted of 38% women with a mean (SD) age of 60.3 (7.6) years. For the 152 patients with 6-month follow-up (75 patients in PnR [85%] and 77 patients in PPV [88%]), there was evidence for an association of PnR with superior vision-related functioning compared with PPV for several subscales. There were no differences between groups at 1 year. After adjusting for age, sex, baseline macular status, visual acuity in the nonstudy eye, and lens status, patients who underwent PnR had higher scores for distance activities (mean [SD] PnR, 88.7 [13.4]; PPV, 82.8 [17.1]; adjusted difference, 6.5; 95% CI, 1.6-11.4; P = .01), mental health (mean [SD] PnR, 84.3 [17.4]; PPV, 78.7 [21.1]; adjusted difference, 6.7; 95% CI, 0.4-13; P = .04), dependency (mean [SD] PnR, 96.1 [10.1]; PPV, 91.1 [18.6]; adjusted difference, 5.7; 95% CI, 0.6-10.8; P = .03), and peripheral vision (mean [SD] PnR, 91.6 [16.2]; PPV, 81.2 [24.4]; adjusted difference, 10.8; 95% CI, 4.3-17.4; P = .001) at 6 months.
Conclusions and Relevance


These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV.
Trial Registration


ClinicalTrials.gov Identifier: NCT01639209.",2020,"These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV.
","['Primary Rhegmatogenous Retinal Detachment', ""Primary Rhegmatogenous Retinal Detachment Outcomes randomized clinical trial conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada"", 'The PnR group consisted of 32% women with a mean (SD) age of 60.9 (9.3) years, while the PPV group consisted of 38% women with a mean (SD) age of 60.3 (7.6) years', 'Patients with RRD', 'Patients Undergoing', '160 patients were included in this analysis, with 81 patients (92%) and 79 patients (90%) in the PnR and PPV groups, respectively']","['Pneumatic Retinopexy vs Vitrectomy', 'rhegmatogenous retinal detachment (RRD) repair techniques', 'pneumatic retinopexy (PnR) and pars plana vitrectomy (PPV']","['mental health scores and superior vision-related functioning scores', '25-Item National Eye Institute Visual Function Questionnaire 12 subscale scores', '25-Item National Eye Institute Visual Function Questionnaire', 'peripheral vision', 'mental health', 'distance activities']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0395578', 'cui_str': 'Pneumatic retinopexy'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0234628', 'cui_str': 'Peripheral vision'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",160.0,0.412786,"These findings demonstrate that patients undergoing PnR for RRD report higher mental health scores and superior vision-related functioning scores in several subscales of the 25-Item National Eye Institute Visual Function Questionnaire during the first 6 months postoperatively compared with PPV.
","[{'ForeName': 'Rajeev H', 'Initials': 'RH', 'LastName': 'Muni', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Carolina L M', 'Initials': 'CLM', 'LastName': 'Francisconi', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Felfeli', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael Y K', 'Initials': 'MYK', 'LastName': 'Mak', 'Affiliation': 'Division of Ophthalmology, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Berger', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Wong', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Filiberto', 'Initials': 'F', 'LastName': 'Altomare', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Louis R', 'Initials': 'LR', 'LastName': 'Giavedoni', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Radha P', 'Initials': 'RP', 'LastName': 'Kohly', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kertes', 'Affiliation': 'Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Figueiredo', 'Affiliation': ""St Michael's Hospital, Department of Ophthalmology, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Roxane J', 'Initials': 'RJ', 'LastName': 'Hillier', 'Affiliation': 'Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne, England.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2007']
1143,32535646,Patient safety incidents and medication errors during a clinical trial: experience from a pre-hospital randomized controlled trial of emergency medication administration.,"AIM


To assess and evaluate patient safety incidents and in particular, medication errors, during a large multi-center pre-hospital trial of emergency therapy (PARAMEDIC2), in order to inform and improve future pre-hospital medicines trials.
METHODS


The PARAMEDIC2 trial was undertaken across five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017. Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation were randomly assigned to 1 mg intravenous adrenaline or matching placebo. Records were reviewed to identify trial medication errors involving documentation and/or clinical protocol errors occurring in trial participants. Causes of medication errors, including root cause analysis where available, were reviewed to identify patterns and themes contributing to these errors.
RESULTS


Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication. A total of 331 patient safety incidents was reported, involving 295 patients, representing an overall rate of 3.6% of these, 166 (50.2%) were documentation errors while 165 (49.8%) were clinical protocol/medication errors. An overall rate of 0-4.5% was reported across all five ambulance services, with a mean of 2.0%. These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs. A similar number of patients had documentation errors. This study is the first to provide data on patient safety incidents relating to medication errors encountered during a pre-hospital trial of emergency medication administration and will provide supporting data for planning future trials in this area.",2020,These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs.,"['Patients with an out -of-hospital cardiac arrest unresponsive to initial resuscitation', 'five NHS Ambulance Services in England and Wales with randomisation between December 2014 and October 2017', 'Eight thousand sixteen patients were enrolled, of whom 4902 received trial medication']",['adrenaline or matching placebo'],"['overall medication error rate', 'overall rate', 'documentation errors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C3840857', 'cui_str': '8000'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025115', 'cui_str': 'Medication error'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",8016.0,0.110179,These errors had no impact on patient care or the trial and were all resolved CONCLUSION: The overall medication error rate of 1.8% primarily consisted of administration of open-label adrenaline and confusion with trial medication packs.,"[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'England', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gates', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': ""O'Shea"", 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pocock', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Rees', 'Affiliation': 'Welsh Ambulance Services NHS Trust, Swansea, Wales, SA2 8PP, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Scomparin', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK. paramedic@warwick.ac.uk.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02887-z']
1144,32682996,THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design.,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.",2020,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","['Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress', 'teens with type 1 diabetes', 'adolescents with T1D']","['Diabetes Education + text-message-based Positive Affect intervention', 'Positive psychology intervention']","[""adolescents' diabetes distress, self-management, and glycemic control"", 'diabetes distress']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0417244,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Datye', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Morrow', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Sinisterra', 'Affiliation': ""Children's National Hospital, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'LeStourgeon', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Fayo', 'Initials': 'F', 'LastName': 'Abadula', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': ""Children's National Hospital, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106086']
1145,32548619,"Sublobar resection versus lobectomy for patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis: a phase III study evaluating survival (JCOG1708, SURPRISE).","The standard treatment for the patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy. However, if patients have idiopathic pulmonary fibrosis combined with early stage lung cancer, there is no standard treatment for this population. Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function; thus, the preservation of respiratory function is essential. The aim of this trial is to confirm the clinical effectiveness of sublobar resection such as wedge resection or segmentectomy for early NSCLC with idiopathic pulmonary fibrosis compared with lobectomy in a randomized phase III trial. The primary endpoint is overall survival. If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis. A planned total 430 patients will be enrolled from 50 institutions over 5 years. This trial has been registered in the UMIN Clinical Trials Registry with code UMIN000032696 [http://www.umin.ac.jp/ctr/index.htm].",2020,"If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis.","['patients have idiopathic pulmonary fibrosis combined with early stage lung cancer', 'A planned total 430 patients will be enrolled from 50 institutions over 5\xa0years', 'Patients with idiopathic pulmonary fibrosis have chronic progressive decline in respiratory function', 'patients with surgically resectable early non-small cell lung cancer (NSCLC) is lung lobectomy', 'early NSCLC with idiopathic pulmonary fibrosis', 'patients with resectable stage I non-small cell lung cancer with idiopathic pulmonary fibrosis']","['Sublobar resection versus lobectomy', 'sublobar resection such as wedge resection or segmentectomy']",['overall survival'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0278504', 'cui_str': 'Non-small cell lung cancer stage I'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0184909', 'cui_str': 'Wedge resection - action'}, {'cui': 'C0024885', 'cui_str': 'Partial mastectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",430.0,0.0933941,"If the non-inferiority of overall survival and minimal invasiveness are proven, it can be a new standard treatment for early NSCLC with idiopathic pulmonary fibrosis.","[{'ForeName': 'Kiyo', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tsutani', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Wakabayashi', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiju', 'Initials': 'K', 'LastName': 'Aokage', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kuroda', 'Affiliation': 'Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Saji', 'Affiliation': 'Department of Chest Surgery, St. Marianna University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Watanabe', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Morihito', 'Initials': 'M', 'LastName': 'Okada', 'Affiliation': 'Department of Surgical Oncology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa092']
1146,32545655,Effect of C242T Polymorphism in the Gene Encoding the NAD(P)H Oxidase p22 phox  Subunit and Aerobic Fitness Levels on Redox State Biomarkers and DNA Damage Responses to Exhaustive Exercise: A Randomized Trial.,"NAD(P)H oxidases (NOXs) constitute a principal source of cellular reactive oxygen species (ROS) and contribute to exercise-induced ROS production in the skeletal muscle. Here, we aimed to investigate the effect of single-bout exhaustive exercise on redox state biomarkers and oxidative DNA damage based on the C242T polymorphism in the gene encoding NOXs subunit p22 phox  ( CYBA ) and aerobic fitness levels. We enrolled 220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110), who were divided into CC genotype and T allele groups through the analysis of the  CYBA  C242T polymorphism. Furthermore, maximum oxygen uptake (VO 2 max) was evaluated to divide subjects into high fitness (HF; 70th percentile for aerobic fitness) and mid-range fitness (MF; 40-60th percentile for aerobic fitness) groups, with a total of 32 subjects assigned to four groups (eight subjects per group): CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF). All subjects performed treadmill running exercise at 85% of VO 2 max until exhaustion. Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM]) were measured in the blood samples obtained immediately before (IBE), immediately after (IAE), and 30 min after exercise (30 MAE). Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05). All groups displayed increased plasma MDA levels at IAE rather than at IBE, with CC + MF being significantly higher than T + HF ( p  < 0.05); only the CC + HF and T + HF groups exhibited a significant reduction at 30 MAE ( p  < 0.05). Moreover, TL at IAE was significantly higher in the CC + MF group than in the T + HF group ( p  < 0.05), and significantly higher in the CC + MF and CC + HF groups than in the T + HF group at 30 MAE ( p  < 0.05). TM was significantly higher in the T + MF than in the T + HF group at IAE ( p  < 0.05) and that of CC + MF was significantly higher than CC + HF and T + HF values at IAE and 30 MAE ( p  < 0.05). These results suggest that single-bout exhaustive exercise could induce peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage. Moreover, high aerobic fitness levels combined with the T allele may protect against exercise-induced redox imbalance and DNA damage.",2020,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","['220 healthy adults in their 20s (men,  n  = 110; women,  n  = 110']","['C242T Polymorphism', 'treadmill running exercise', 'CC + MF', 'CC genotype and HF group (CC + HF), CC genotype and MF group (CC + MF), T allele and HF group (T + HF), and T allele and MF group (T + MF', 'single-bout exhaustive exercise']","['peripheral fatigue and the accumulation of temporary redox imbalance and oxidative DNA damage', 'plasma MDA levels', 'Plasma lactate, malondialdehyde (MDA), superoxide dismutase (SOD), and lymphocyte DNA damage (tail DNA percentage [TD], tail length [TL], and the tail moment [TM', 'Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM', 'TM', 'TL at IAE', 'maximum oxygen uptake (VO 2 max']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1272145', 'cui_str': 'Plasma lactate level'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",220.0,0.020247,"Plasma lactate levels, SOD activities, and lymphocyte DNA damage markers (TD, TL, and TM) were significantly increased at IAE than that at IBE and significantly decreased at 30 MAE ( p  < 0.05).","[{'ForeName': 'Su-Youn', 'Initials': 'SY', 'LastName': 'Cho', 'Affiliation': 'Exercise Physiology Laboratory, Department of Physical Education, Yonsei University, Seoul 03722, Korea.'}, {'ForeName': 'Wi-Young', 'Initials': 'WY', 'LastName': 'So', 'Affiliation': 'Sports and Health Care Major, College of Humanities and Arts, Korea National University of Transportation, Chungju-si 27469, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17124215']
1147,32552523,Cooling as an Adjunctive Therapy to Percutaneous Intervention in Acute Myocardial Infarction: COOL-MI InCor Trial.,"Endovascular Therapeutic hypothermia (ETH) reduces the damage caused by postischemia reperfusion injury syndrome in cardiopulmonary arrest and has already established its role in patients with sudden death; however, its role in ST-segment elevation myocardial infarction (STEMI) remains controversial. The objectives of this study were to investigate the safety, feasibility, and 30-day efficacy of rapid induction of therapeutic hypothermia as adjunctive therapy to percutaneous coronary intervention (PCI) in patients with anterior and inferior STEMIs. This was a prospective, controlled, randomized, two-arm, prospective, interventional study of patients admitted to the emergency department within 6 hours of angina onset, with anterior or inferior STEMI eligible for PCI. Subjects were randomized to the hypothermia group (primary PCI+ETH) or to the control group (primary PCI) at a 4:1 ratio. The ETH was induced by 1 L cold saline (1-4°C) associated with the Proteus™ System, by cooling for at least 18 minutes before coronary reperfusion with a target temperature of 32°C ± 1°C. Maintenance of ETH was conducted for 1-3 hours, and active reheating was done at a rate of 1°C/h for 4 hours. Primary safety outcomes were the feasibility of ETH in the absence of (1) door-to-balloon (DTB) delay; (2) major adverse cardiac events (MACE) within 30 days after randomization. The primary outcomes of effectiveness were infarct size (IS) and left ventricular ejection fraction (LVEF) at 30 days. An as-treated statistical analysis was performed. Fifty patients were included: 35 (70%) randomized to the hypothermia group and 15 (30%) to the control group. The mean age was 58 ± 12 years; 78% were men; and associated diseases were 60% hypertension, 42% diabetes, and 72% dyslipidemia. The compromised myocardial wall was anterior in 38% and inferior in 62%, and the culprit vessels were left anterior descending artery (LAD) (40%), right coronary artery (38%), and left circumflex (18%). All 35 patients who attempted ETH (100%) had successful cooling, with a mean endovascular coronary reperfusion temperature of 33.1°C ± 0.9°C. The mean ischemic time was 375 ± 89.4 minutes in the hypothermia group and 359.5 ± 99.4 minutes in the control group. The mean DTB was 92.1 ± 20.5 minutes in the hypothermia group and 87 ± 24.4 minutes in the control group. The absolute difference of 5.1 minutes was not statistically significant ( p  = 0.509). The MACE rates were similar between both groups (21.7% vs. 20% respectively,  p  = 0.237). In the comparison between the hypothermia and control groups, no statistically significant differences were observed at 30 days between mean IS (13.9% ± 8% vs. 13.8% ± 10.8%, respectively,  p  = 0.801) and mean final LVEF (43.3% ± 11.2% vs. 48.3 ± 10.9%, respectively;  p  = 0.194). Hypothermia as an adjunctive therapy to primary PCI in STEMI is feasible and can be implemented without delay in coronary reperfusion. Hypothermia was safe regarding the incidence of MACE at 30 days. However, there was a higher incidence of arrhythmia and in-hospital infection in the hypothermia group, with no increase in mortality. Regarding efficacy, there was no difference in IS or LVEF at 30 days that would suggest additional myocardial protection with ETH. ClinicalTrials.gov: NCT02664194.",2020,"The MACE rates were similar between both groups (21.7% vs. 20% respectively,  p  = 0.237).","['All 35 patients who attempted ETH (100%) had successful cooling, with a mean endovascular coronary reperfusion temperature of 33.1°C\u2009±\u20090.9°C', 'patients admitted to the emergency department within 6 hours of angina onset, with anterior or inferior STEMI eligible for PCI', 'Fifty patients were included: 35 (70%) randomized to the', 'patients with sudden death', 'Acute Myocardial Infarction', 'patients with anterior and inferior STEMIs', 'The mean age was 58\u2009±\u200912 years; 78% were men; and associated diseases were 60% hypertension, 42% diabetes, and 72% dyslipidemia']","['percutaneous coronary intervention (PCI', 'hypothermia', 'Percutaneous Intervention', 'Endovascular Therapeutic hypothermia (ETH', 'hypothermia group (primary PCI+ETH', 'control group (primary PCI']","['arrhythmia and in-hospital infection', 'MACE rates', 'mean DTB', 'mean ischemic time', 'mean final LVEF', 'mortality', 'safety, feasibility, and 30-day efficacy', 'feasibility of ETH in the absence of (1) door-to-balloon (DTB) delay; (2) major adverse cardiac events (MACE', 'infarct size (IS) and left ventricular ejection fraction (LVEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0020672', 'cui_str': 'Hypothermia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]",50.0,0.0457433,"The MACE rates were similar between both groups (21.7% vs. 20% respectively,  p  = 0.237).","[{'ForeName': 'Luis Augusto Palma', 'Initials': 'LAP', 'LastName': 'Dallan', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Natali Schiavo', 'Initials': 'NS', 'LastName': 'Giannetti', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Rochitte', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Thatiane Facholi', 'Initials': 'TF', 'LastName': 'Polastri', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Claudia Yanet', 'Initials': 'CY', 'LastName': 'Bernoche San Martin', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ludhmila Abrahao', 'Initials': 'LA', 'LastName': 'Hajjar', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Felipe Gallego', 'Initials': 'FG', 'LastName': 'Lima', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mucio Tavares de', 'Initials': 'MT', 'LastName': 'Oliveira', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dae', 'Affiliation': 'Department of Radiology, UCSF, University of California, San Francisco, California, USA.'}, {'ForeName': 'Expedito Eustaquio', 'Initials': 'EE', 'LastName': 'Ribeiro da Silva', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Kalil Filho', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Pedro Alves', 'Initials': 'PA', 'LastName': 'Lemos Neto', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Timerman', 'Affiliation': 'Department of Cardiology, InCor, Heart Institute, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Therapeutic hypothermia and temperature management,['10.1089/ther.2020.0018']
1148,32556539,"Absence of QTc prolongation in a thorough QT study with imeglimin, a first in class oral agent for type 2 diabetes mellitus.","PURPOSE


Imeglimin is the first in a new class of oral antidiabetic agents, the glimins, currently in development to improve glycemic control in patients with type 2 diabetes mellitus. A thorough QT study was conducted to establish electrophysiological effects of therapeutic and supratherapeutic doses of imeglimin on cardiac repolarization.
METHODS


In this randomized, double-blind, four-period, placebo and active controlled crossover study, healthy subjects were administered a single dose of imeglimin 2250 mg, imeglimin 6000 mg, moxifloxacin 400 mg, and placebo. 12-Lead Holter ECGs were recorded from 1 h before dosing until at least 24 h after each dose. This study was performed at a single-center inpatient clinical pharmacology unit.
RESULTS


The upper bound of the two-sided 90% confidence interval for time-matched, placebo-subtracted, baseline-adjusted QTc intervals (ΔΔQTcF) did not exceed the regulatory threshold of 10 ms in any of the imeglimin dose groups. There were no QTcF values above 500 ms nor changes from pre-dose in QTcF above 60 ms in the imeglimin groups. Imeglimin did not exert a relevant effect on heart rate and PR or QRS intervals. Assay sensitivity was demonstrated by the effect of moxifloxacin 400 mg, with a lower bound two-sided 90% confidence interval for ΔΔQTcF of 10.6 ms.
CONCLUSION


This thorough QT study demonstrated that therapeutic and supratherapeutic exposures of imeglimin did not induce a QT/QTc prolongation with a strong confidence as evidenced by the assay sensitivity.
TRIAL REGISTRATION NUMBER/DATE


NCT02924337/ October 5, 2016.",2020,There were no QTcF values above 500 ms nor changes from pre-dose in QTcF above 60 ms in the imeglimin groups.,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus', 'healthy subjects']","['imeglimin 2250 mg, imeglimin 6000 mg, moxifloxacin 400 mg, and placebo', 'moxifloxacin', 'placebo']","['QTcF values', 'heart rate and PR or QRS intervals', 'Assay sensitivity', '12-Lead Holter ECGs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3501765', 'cui_str': 'imeglimin'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",,0.169849,There were no QTcF values above 500 ms nor changes from pre-dose in QTcF above 60 ms in the imeglimin groups.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubourg', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France. julie.dubourg@poxelpharma.com.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Perrimond-Dauchy', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Felices', 'Affiliation': 'Phinc Development, 36 rue Victor Basch, Massy, 91300, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bolze', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Voiriot', 'Affiliation': 'Banook group, 84 avenue du XXeme Corps, Nancy, 54000, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'POXEL S.A., 259/261 Avenue Jean Jaurès, 69007, Lyon, France.'}]",European journal of clinical pharmacology,['10.1007/s00228-020-02929-6']
1149,32556585,Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study.,"PURPOSE


To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques.
METHODS


The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm 2 , (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B.
RESULTS


No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm 2  in the UL-group, 71.9 (SD 37.1) mm 2  in the BL-group and 68.1 (SD 41.0) mm 2  in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found.
CONCLUSION


For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area.
CLINICAL TRIAL REGISTRATION


The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.",2020,No differences between the three surgical groups were found in the mean increase in dural sac area.,"['437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n\u2009=\u2009146', 'patients with lumbar spinal stenosis', 'patients undergoing surgery for lumbar spinal stenosis', 'lumbar spinal stenosis']","['posterior decompression techniques', 'bilateral laminotomy (BL) (n\u2009=\u2009142) and spinous process osteotomy (SPO']","['Mean values', 'dural sac area', 'dural sac area and\xa0Schizas grade', 'dural sac area of at least 50% and (3) postoperative Schizas grade A or B']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0392866', 'cui_str': 'Laminotomy'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}]",437.0,0.0565306,No differences between the three surgical groups were found in the mean increase in dural sac area.,"[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Hermansen', 'Affiliation': 'Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway. Erland.hermansen@helse-bergen.no.'}, {'ForeName': 'Ivar Magne', 'Initials': 'IM', 'LastName': 'Austevoll', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hellum', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital Ulleval, Oslo, Norway.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Communication and Research Unit for Musculoskeletal Health (FORMI), Oslo University Hospital,, Oslo, Norway.'}, {'ForeName': 'Tor Åge', 'Initials': 'TÅ', 'LastName': 'Myklebust', 'Affiliation': 'Department of Research and Innovation, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Aaen', 'Affiliation': 'Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Diagnostic Imaging, Akershus University Hospital,, Oslo, Norway.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Anvar', 'Affiliation': 'Unilabs Radiology, Oslo, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Rekeland', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Franssen', 'Affiliation': 'Department of Orthopaedics, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Weber', 'Affiliation': 'Department of Neurosurgery, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Solberg', 'Affiliation': 'Department of Neurosurgery and the Norwegian Registry for Spine Surgery (NORspine), University Hospital of Northern Norway, Tromsö, Norway.'}, {'ForeName': 'Knut Jørgen', 'Initials': 'KJ', 'LastName': 'Haug', 'Affiliation': 'Departement of Orthopedic Surgery, Telemark Regional Hospital, Skien, Norway.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Grundnes', 'Affiliation': 'Department of Orthopedics, Akershus University Hospital, Oslo, Norway.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brisby', 'Affiliation': 'Department of Orthopaedics, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Indrekvam', 'Affiliation': 'Kysthospitalet in Hagevik. Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06499-0']
1150,32551868,"Maximum Bridging Suture Tension Provides Better Clinical Outcomes in Transosseous-Equivalent Rotator Cuff Repair: A Clinical, Prospective Randomized Comparative Study.","BACKGROUND


Some studies reporting clinical outcomes after transosseous-equivalent (TOE) repair have attributed type II rotator cuff failure to excessive bridging suture tension, as it can cause overloading on the medial row. In a previous biomechanical cadaveric study, increasing bridging suture tension over 90 N did not improve the contact area and ultimate failure load of the TOE construct, despite increasing the contact force and contact pressure.
PURPOSE


To compare the clinical outcomes of different bridging suture tensions after TOE rotator cuff repair based on the results of a previous biomechanical study.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 78 patients who underwent arthroscopic rotator cuff repair for medium- to large-sized tears were prospectively enrolled and randomly divided into 2 groups according to the applied bridging suture tension: optimum tension group (96.3 ± 4.9 N) and maximum tension group (199.0 ± 20.3 N). Bridging suture tension was measured with a customized tensiometer, as used in the previous biomechanical study. The functional outcome was measured at the final follow-up (27.4 ± 5.9 months [range, 24-45 months]) using the visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Constant score, and the anatomic outcome was evaluated using magnetic resonance imaging or ultrasonography at least 12 months after surgery.
RESULTS


Overall, 64 patients (32 in each group) were analyzed. The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05). Regarding the anatomic outcomes, the maximum tension group (n = 1; 3.1%) had a significantly lower healing failure rate than the optimum tension group (n = 9; 28.1%) ( P  = .013). One patient in the maximum tension group had a type II failure.
CONCLUSION


Maximum bridging suture tension in TOE repair for medium- to large-sized rotator cuff tears provided better anatomic healing with less risk of medial rotator cuff failure, which differs from the results of a previous time-zero biomechanical study.",2020,The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05).,"['Transosseous-Equivalent Rotator Cuff Repair', '78 patients who underwent arthroscopic rotator cuff repair for medium- to large-sized tears', '64 patients (32 in each group) were analyzed']","['Maximum Bridging Suture Tension', 'Maximum bridging suture tension in TOE repair for medium- to large-sized rotator cuff tears', 'bridging suture tension: optimum tension group (96.3 ± 4.9 N) and maximum tension', 'bridging suture tensions after TOE rotator cuff repair', 'transosseous-equivalent (TOE) repair']","['visual analog scale for pain, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Constant score, and the anatomic outcome', 'healing failure rate', 'type II failure']","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",78.0,0.0432952,The functional outcomes improved significantly compared with preoperative values (all  P  < .05) but did not show significant differences between the 2 groups (all  P  > .05).,"[{'ForeName': 'Joo Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Ji Soon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Healthpoint, Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Rhee', 'Affiliation': 'Shoulder and Elbow Clinic, Department of Orthopedic Surgery, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Bundang Jesaeng General Hospital, Daejin Medical Center, Seongnam, Republic of Korea.'}]",The American journal of sports medicine,['10.1177/0363546520930425']
1151,32559759,Short-term nicotine deprivation alters dorsal anterior cingulate glutamate concentration and concomitant cingulate-cortical functional connectivity.,"Most cigarette smokers who wish to quit too often relapse within the first few days of abstinence, primarily due to the aversive aspects of the nicotine withdrawal syndrome (NWS), which remains poorly understood. Considerable research has suggested that the dorsal anterior cingulate cortex (dACC) plays a key role in nicotine dependence, with its functional connections between other brain regions altered as a function of trait addiction and state withdrawal. The flow of information between dACC and fronto-striatal regions is secured through different pathways, the vast majority of which are glutamatergic. As such, we investigated dACC activity using resting state functional connectivity (rsFC) with functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS). We also investigated the changes in adenosine levels in plasma during withdrawal as a surrogate for brain adenosine, which plays a role in fine-tuning synaptic glutamate transmission. Using a double-blind, placebo-controlled, randomized crossover design, nontreatment seeking smoking participants (N = 30) completed two imaging sessions, one while nicotine sated and another after 36 h nicotine abstinence. We observed reduced dACC Glu (P = 0.029) along with a significant reduction in plasma adenosine (P = 0.03) and adenosine monophosphate (AMP; P < 0.0001) concentrations during nicotine withdrawal in comparison with nicotine sated state. This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG). Moreover, the state-trait changes in dACC Glu and rsFC strength between the dACC and both SFG and MFG were positively correlated (P = 0.012, and P = 0.007, respectively). Finally, the change in circuit strength between dACC and LSFG was negatively correlated with the change in withdrawal symptom manifestations as measured by the Wisconsin Smoking Withdrawal Scale (P = 0.04) and Tobacco Craving Questionnaire (P = 0.014). These multimodal imaging-behavioral findings reveal the complex cascade of changes induced by acute nicotine deprivation and call for further investigation into the potential utility of adenosine- and glutamate-signaling as novel therapeutic targets to treat the NWS.",2020,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).",['nontreatment seeking smoking participants (N\u2009=\u200930) completed two'],"['placebo', 'Short-term nicotine deprivation', 'imaging sessions, one while nicotine sated and another after 36\u2009h nicotine abstinence', 'functional magnetic resonance imaging (fMRI) and glutamate (Glu) concentration with magnetic resonance spectroscopy (MRS']","['plasma adenosine', 'left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG', 'Wisconsin Smoking Withdrawal Scale', 'dACC Glu', 'dACC Glu and rsFC strength', 'rsFC strength', 'withdrawal symptom manifestations', 'circuit strength', 'Tobacco Craving Questionnaire']","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0152296', 'cui_str': 'Structure of superior frontal gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0275209,"This withdrawal state manipulation also led to an increase in rsFC strength (P < 0.05) between dACC and several frontal cortical regions, including left superior frontal gyrus (LSFG), and right middle frontal gyrus (RMFG).","[{'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Abulseoud', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA. osama.abulseoud@nih.gov.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hyung Wook', 'Initials': 'HW', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology, Toxicology and Neuroscience, LSU Health Sciences Center, Shreveport, LA, USA.'}, {'ForeName': 'Elisabeth C', 'Initials': 'EC', 'LastName': 'Caparelli', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tennekoon', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Schleyer', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fedota', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, Intramural Research Program, National Institute on Drug Abuse, Baltimore, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0741-9']
1152,32560544,Active Breaks: A Pilot and Feasibility Study to Evaluate the Effectiveness of Physical Activity Levels in a School Based Intervention in an Italian Primary School.,"Background:  The school gives access to children, regardless of age, ethnicity, gender and socio-economic class and can be identified as the key environment in which to promote children's physical activity (PA). The guidelines of the European Union recommend accumulating at least 10-min bouts of PA to reach the daily 60 min. Active breaks (ABs) led by teachers inside the classroom represent a good strategy to promote PA. The aim of this pilot and feasibility study was to evaluate the feasibility and effectiveness in terms of PA level of an AB programme in children aged 8-9 years attending primary school.  Methods:  A pre-post quasi-experimental pilot and feasibility study was performed in two primary school classes, one of which was assigned to a 14-week AB intervention (AB group) and the other to the control group (CG). At baseline and at follow-up, children were monitored for sedentary and motor activity during an entire week using ActiGraph Accelerometer (ActiLife6 wGT3X-BT). The satisfaction of children and teachers was assessed by self-administered questionnaires.  Results:  In the pre-post comparison, AB group ( n  = 16) showed a reduction in the minutes spent in weekly sedentary activity (-168.7 min,  p  > 0.05), an increase in the number of step counts (+14,026.9,  p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%. On the contrary, CG showed a worsening in all variables. ANCOVA analysis, after adjusting for baseline values, showed significant differences between the AB group and CG for time spent in MVPA, percentage of MVPA and step counts. The satisfaction of children and teachers was good. Teachers were able to adapt the AB protocol to the needs of the school curriculum, thus confirming the feasibility of the AB programme.  Conclusions:  This pilot and feasibility study showed the feasibility and effectiveness of the AB protocol and represented the basis for a future controlled trial.",2020,"p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","['children aged 8-9 years attending primary school', 'Italian Primary School']",['AB programme'],"['number of step counts', 'minutes spent in weekly sedentary activity', 'Physical Activity Levels', 'feasibility and effectiveness']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2.0,0.0270913,"p  < 0.05) and in time spent in moderate to vigorous PA (MVPA): weekly MVPA: +64.4 min, daily MVPA: +8.05 min, percentage of MVPA: +0.70%.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Masini', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Leoni', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lorusso', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Toselli', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via Selmi, 3, 40126 Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tessari', 'Affiliation': 'Department of Psychology, University of Bologna, Bologna Viale Berti Pichat, 5, 40126 Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ceciliani', 'Affiliation': ""Department of Life Quality Studies, University of Bologna, Campus of Rimini, Rimini Corso d'Augusto 237, 47921 Rimini, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dallolio', 'Affiliation': 'Department of Biomedical and Neuromotor Science, University of Bologna, Bologna Via San Giacomo, 12, 40126 Bologna, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17124351']
1153,32562376,"Effect of the FreeStyle Libre™ flash glucose monitoring system on glycemic control in individuals with type 2 diabetes treated with basal-bolus insulin therapy: An open label, prospective, multicenter trial in Japan.","AIMS/INTRODUCTION


We investigated the effect of FreeStyle Libre TM  on glycemic control in Japanese type 2 diabetes patients treated with basal-bolus insulin therapy.
MATERIALS AND METHODS


This prospective, 90-day single-arm study enrolled 94 adults with type 2 diabetes treated with insulin. A 14-day masked baseline phase was followed by an 11-week treatment phase during which participants used the device to monitor glucose levels. The primary end-point was time spent in hypoglycemia (<70 mg/dL) for baseline versus study end (days 76-90). Secondary end-points included other measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire.
RESULTS


Time spent in hypoglycemia was low at baseline (0.51 ± 0.93 h/day) and did not significantly decrease at study end (0.47 ± 0.63 h/day, P = 0.6354). Time in range, time in hyperglycemia and estimated A1c all improved versus baseline (by +1.7 ± 3.0 h/day, -1.6 ± .4 h/day and -0.4 ± 0.8%, respectively, P < 0.0001 in each). Finger stick tests fell from 2.9 ± 1.3 to 1.9 ± 1.4/day, and mean scanning frequency during the intervention phase was 11.3/day. The mean treatment satisfaction score increased by 11.8 ± 5.3 (P < 0.0001). Two severe hypoglycemia-related adverse events were reported; one of which was possibly related to the device. Three participants reported mild device-related skin trauma, site discomfort or subcutaneous bleeding.
CONCLUSIONS


Use of FreeStyle Libre by Japanese type 2 patients diabetes treated with basal-bolus insulin therapy showed a low baseline of hypoglycemia, and enabled improved glycemic control and treatment satisfaction.",2020,Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001).,"['Japanese type 2 diabetes subjects treated with basal-bolus insulin therapy', '94 adults with type 2 diabetes treated with insulin', 'Subjects with Type 2 Diabetes Treated with Basal-Bolus Insulin Therapy']","['FreeStyle Libre TM', 'FreeStyle Libre TM  Flash Glucose Monitoring System', 'FreeStyle Libre']","['severe hypoglycemia-related adverse events', 'measures of glycemic control, along with patient satisfaction using the Japanese Diabetes Treatment and Satisfaction Questionnaire (DTSQ', 'mean scanning frequency', 'glycemic control and treatment satisfaction', 'mild device-related skin trauma, site discomfort or subcutaneous bleeding', 'Time spent in hypoglycemia', 'Mean treatment satisfaction score', 'Time in range, time in hyperglycemia', 'glycemic control', 'time spent in hypoglycemia']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C2750515', 'cui_str': 'Subcutaneous bleeding'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",94.0,0.0575329,Mean treatment satisfaction score increased by 11.8 ± 5.3 (p<0.0001).,"[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Ogawa', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Osonoi', 'Affiliation': 'Nakakinen Clinic, Ibaraki, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tosaki', 'Affiliation': 'TDE Healthcare Corporation, TOSAKI Clinic for Diabetes and Endocrinology, Aichi, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Kato', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Utsunomiya', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Rimei', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Division of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Aichi, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13327']
1154,32567975,Effects of aerobic and cognitively-engaging physical activity on academic skills: A cluster randomized controlled trial.,"This cluster randomized controlled trial (trial-number #) compares effects of two school-based physical activity interventions (aerobic vs. cognitively-engaging) on reading, mathematics, and spelling achievement; and whether effects are influenced by volume of moderate-to-vigorous physical activity and baseline achievement. Twenty-two primary schools participated, where a third and fourth grade class were randomly assigned to the intervention or control group. Intervention groups were randomly assigned to a 14-week aerobic or cognitively-engaging intervention, receiving four physical education lessons a week. Control groups followed their regular physical education program. Academic achievement of 891 children (mean age 9.17 years, 49.4% boys) was assessed with standardized tests before and after the interventions. Post-Test academic achievement did not significantly differ between intervention groups and control group. A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group. Compared to the control group, lower achievers in reading performed better in reading after the cognitively-engaging intervention. A combination of moderate-to-vigorous physical activity and cognitively-engaging exercises seems to have the most beneficial effects. Future intervention studies should take into account quantitative and qualitative aspects of physical activity, and children's baseline academic achievement.",2020,"A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group.","['891 children (mean age 9.17\xa0years, 49.4% boys', 'academic skills', 'Twenty-two primary schools participated, where a third and fourth grade class']","['regular physical education program', '14-week aerobic or cognitively-engaging intervention, receiving four physical education lessons a week', 'aerobic and cognitively-engaging physical activity', 'two school-based physical activity interventions (aerobic vs. cognitively-engaging']","['Post-Test academic achievement', 'reading, mathematics, and spelling achievement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",891.0,0.0342309,"A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group.","[{'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'De Bruijn', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Danny D N M', 'Initials': 'DDNM', 'LastName': 'Kostons', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'Van Der Fels', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Visscher', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam , Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hartman', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Bosker', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756680']
1155,32568399,Evaluation of a Machine Learning Model Based on Pretreatment Symptoms and Electroencephalographic Features to Predict Outcomes of Antidepressant Treatment in Adults With Depression: A Prespecified Secondary Analysis of a Randomized Clinical Trial.,"Importance


Despite the high prevalence and potential outcomes of major depressive disorder, whether and how patients will respond to antidepressant medications is not easily predicted.
Objective


To identify the extent to which a machine learning approach, using gradient-boosted decision trees, can predict acute improvement for individual depressive symptoms with antidepressants based on pretreatment symptom scores and electroencephalographic (EEG) measures.
Design, Setting, and Participants


This prognostic study analyzed data collected as part of the International Study to Predict Optimized Treatment in Depression, a randomized, prospective open-label trial to identify clinically useful predictors and moderators of response to commonly used first-line antidepressant medications. Data collection was conducted at 20 sites spanning 5 countries and including 518 adult outpatients (18-65 years of age) from primary care or specialty care practices who received a diagnosis of current major depressive disorder between December 1, 2008, and September 30, 2013. Patients were antidepressant medication naive or willing to undergo a 1-week washout period of any nonprotocol antidepressant medication. Statistical analysis was conducted from January 5 to June 30, 2019.
Exposures


Participants with major depressive disorder were randomized in a 1:1:1 ratio to undergo 8 weeks of treatment with escitalopram oxalate (n = 162), sertraline hydrochloride (n = 176), or extended-release venlafaxine hydrochloride (n = 180).
Main Outcomes and Measures


The primary objective was to predict improvement in individual symptoms, defined as the difference in score for each of the symptoms on the 21-item Hamilton Rating Scale for Depression from baseline to week 8, evaluated using the C index.
Results


The resulting data set contained 518 patients (274 women; mean [SD] age, 39.0 [12.6] years; mean [SD] 21-item Hamilton Rating Scale for Depression score improvement, 13.0 [7.0]). With the use of 5-fold cross-validation for evaluation, the machine learning model achieved C index scores of 0.8 or higher on 12 of 21 clinician-rated symptoms, with the highest C index score of 0.963 (95% CI, 0.939-1.000) for loss of insight. The importance of any single EEG feature was higher than 5% for prediction of 7 symptoms, with the most important EEG features being the absolute delta band power at the occipital electrode sites (O1, 18.8%; Oz, 6.7%) for loss of insight. Over and above the use of baseline symptom scores alone, the use of both EEG and baseline symptom features was associated with a significant increase in the C index for improvement in 4 symptoms: loss of insight (C index increase, 0.012 [95% CI, 0.001-0.020]), energy loss (C index increase, 0.035 [95% CI, 0.011-0.059]), appetite changes (C index increase, 0.017 [95% CI, 0.003-0.030]), and psychomotor retardation (C index increase, 0.020 [95% CI, 0.008-0.032]).
Conclusions and Relevance


This study suggests that machine learning may be used to identify independent associations of symptoms and EEG features to predict antidepressant-associated improvements in specific symptoms of depression. The approach should next be prospectively validated in clinical trials and settings.
Trial Registration


ClinicalTrials.gov Identifier: NCT00693849.",2020,"The importance of any single EEG feature was higher than 5% for prediction of 7 symptoms, with the most important EEG features being the absolute delta band power at the occipital electrode sites (O1, 18.8%; Oz, 6.7%) for loss of insight.","['20 sites spanning 5 countries and including 518 adult outpatients (18-65 years of age) from primary care or specialty care practices who received a diagnosis of current major depressive disorder between December 1, 2008, and September 30, 2013', 'Exposures\n\n\nParticipants with major depressive disorder', '518 patients (274 women; mean [SD] age, 39.0 [12.6] years', 'Patients were antidepressant medication naive or willing to undergo a 1-week washout period of any nonprotocol antidepressant medication', 'Adults With Depression']","['escitalopram oxalate', 'sertraline hydrochloride (n\u2009=\u2009176), or extended-release venlafaxine hydrochloride', 'Machine Learning Model']","['appetite changes (C index increase', 'energy loss (C index increase', 'mean [SD] 21-item Hamilton Rating Scale for Depression score', 'C index scores', 'psychomotor retardation', '21-item Hamilton Rating Scale for Depression', 'individual symptoms', 'C index']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0600526', 'cui_str': 'Sertraline hydrochloride'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0771200', 'cui_str': 'Venlafaxine hydrochloride'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",518.0,0.0823125,"The importance of any single EEG feature was higher than 5% for prediction of 7 symptoms, with the most important EEG features being the absolute delta band power at the occipital electrode sites (O1, 18.8%; Oz, 6.7%) for loss of insight.","[{'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Rajpurkar', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Dass', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Vinjai', 'Initials': 'V', 'LastName': 'Vale', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Arielle S', 'Initials': 'AS', 'LastName': 'Keller', 'Affiliation': 'Stanford Center for Precision Mental Health and Wellness, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Irvin', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Taylor', 'Affiliation': 'Stanford Center for Precision Mental Health and Wellness, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Center for Primary Care, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Department of Computer Science, Stanford University, Stanford, California.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Stanford Center for Precision Mental Health and Wellness, Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6653']
1156,32536316,Clinical comparison of single-incision and dual-incision approaches for the treatment of distal tibial and fibular fractures: A randomized controlled trial.,"PURPOSE


The purpose of this study was to clinically compare the single-incision and dual-incision approaches for the treatment of distal tibial and fibular fractures.
METHODS


In total, 93 patients were enrolled, and the mean follow-up was 15 months (range 12-19 months). The patients treated for open reduction and internal fixation were randomly classified into two groups based on the approach used: 45 patients were treated using the single-incision approach (group 1) and 48 patients were treated using the dual-incision approach (group 2). In these two groups, operation time, discharge time, postoperative complications, and ankle function evaluations (Olerud-Molander Ankle Score) were compared between the two groups.
RESULTS


There were no significant differences in the mean operation time (98.2 ± 18.5 vs. 103.6 ± 19.3), discharge time (11.1 ± 3.9 vs. 12.5 ± 5.7), overall surgical complication rates (9/45 vs. 15/48), or ankle function between the two groups ( p  > 0.05). However, the rate of soft tissue-related complications, such as skin slough, infection, nonunion, and delayed union, was significantly lower in group 1 (5/45) than in group 2 (14/48) ( p  < 0.05).
CONCLUSION


The two incision approaches were found to have similar clinical outcomes. However, with regard to soft tissue conservation, the single-incision approach was superior to the dual-incision and maybe a reliable alternative.",2020,"However, with regard to soft tissue conservation, the single-incision approach was superior to the dual-incision and maybe a reliable alternative.","['distal tibial and fibular fractures', '93 patients were enrolled, and the mean follow-up was 15 months (range 12-19 months', 'patients treated for open reduction and internal fixation']","['dual-incision approach', 'single-incision approach', 'single-incision and dual-incision approaches']","['discharge time', 'ankle function', 'operation time, discharge time, postoperative complications, and ankle function evaluations (Olerud-Molander Ankle Score', 'rate of soft tissue-related complications, such as skin slough, infection, nonunion, and delayed union', 'overall surgical complication rates', 'mean operation time']","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0159852', 'cui_str': 'Fracture of tibia AND fibula'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0027544', 'cui_str': 'Necrotic debris'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",93.0,0.0259224,"However, with regard to soft tissue conservation, the single-incision approach was superior to the dual-incision and maybe a reliable alternative.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'An', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Weihu', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Xianfeng', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Jichong', 'Initials': 'J', 'LastName': 'Ying', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Yunqiang', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': ""Department of Traumatic Orthopedics, Ningbo No. 6 Hospital, Ningbo, Zhejiang, People's Republic of China.""}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020930305']
1157,32683215,Intensive upper extremity training improved whole body movement control for children with unilateral spastic cerebral palsy.,"BACKGROUND


Children with unilateral spastic cerebral palsy (USCP) exhibit impaired bimanual coordination, gait control, and whole body movement control. Intensive upper extremity training has been found to be effective for improving upper extremity function. However, the effectiveness of the intensive upper extremity training on whole body movement control is not known.
RESEARCH QUESTION


The present study aimed to evaluate the effects of Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT) on bimanual coordination and gait control during a complex whole body task.
METHODS


Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS: I-II, MACS: I-II) were randomly assigned to either CIMT or HABIT for 6 h per day training for 15 days. Children were asked to perform two whole body tasks (walking with and without a tray carrying) while 3-D kinematic analysis was performed before and after training.
RESULTS


After training, the HABIT group increased the symmetry in height of their hands during tray carrying (more leveled tray). Both CIMT and HABIT groups decreased the lateral motion of the tray. The CIMT group increased speed and stride length after training in both the walking and tray carrying tasks. Both groups also increased their minimum toe clearance (all p < 0.05).
SIGNIFICANCE


Two types of intensive upper extremity training have provided significant improvements to whole body movement control for children with USCP. Adhering to the specificity of practice concept, HABIT improved bimanual coordination after training during the whole body tray carrying tasks. Given extensive interactions between the upper and lower extremities in real-world activities, future studies should focus on the effects of such combined training.",2020,"Both groups also increased their minimum toe clearance (all p < 0.05).
","['children with unilateral spastic cerebral palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', 'Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS']","['CIMT or HABIT', 'Intensive upper extremity training improved whole body movement control', 'CIMT', 'Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT', 'intensive upper extremity training', 'Intensive upper extremity training']","['bimanual coordination and gait control', 'symmetry in height of their hands', 'speed and stride length', 'lateral motion of the tray', 'minimum toe clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",16.0,0.0108967,"Both groups also increased their minimum toe clearance (all p < 0.05).
","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA. Electronic address: yaching.hung@qc.cuny.edu.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shirzad', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Box 199, NY 10027, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.009']
1158,32683383,Efficacy of ozonized water for the treatment of erosive oral lichen planus: a randomized controlled study.,"BACKGROUND


Management of erosive Oral Lichen Planus (eOLP) is challenging. Currently, topical corticosteroids are widely used as first-line therapy, but they might be associated with side-effects and incomplete clinical response. Among non-pharmacological strategies, ozone at low medical concentration has proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases. The aim of this randomized controlled study was to investigate the effectiveness of ozonized water in association with conventional topical corticosteroids for the treatment of eOLP.
MATERIAL AND METHODS


Fifty-one patients were included in the study and randomized into 2 groups: study group (n=26) included patients receiving ozonized water treatment; control group (n=25) included patients receiving placebo treatment (i.e. double-distilled water). Treatment protocol consisted of 1-minute oral rinses, repeated for 4 times, twice a week for 4 weeks. All patients received conventional corticosteroid topical therapy (betamethasone soluble tablets, 2 rinses/day for 4 weeks). Assessment of size of lesions, sign and pain scores was performed before treatment, after 2 weeks of treatment (T1) and at the end of 4-week treatment (T2). Efficacy Index (EI) of treatment, candidiasis and relapse rates were also recorded.
RESULTS


All patients experienced significant improvement of sign and pain scores with a higher rate of improvement in ozone-treated group (T1 improvement rates: Thongprasom 92.2% vs 28%; VAS pain 76.9% vs 32%; p<0.05). Pain and size reduction were significantly higher in ozone-treated group both at T1 and T2 (p<0.05). Ozone-treated group showed a higher EI at every time point (T0-T2: 72.77% vs 37.66%, p<0.01). Candidiasis (32% vs 11.5%) and relapse (40% vs 34.6%) rates were higher in control group, however the differences were not statistically significant.
CONCLUSIONS


Within the limitations of this study, ozonized water seems to be effective as an adjunct therapy, in combination with topical corticosteroids, for the treatment of eOLP.",2020,Pain and size reduction were significantly higher in ozone-treated group both at T1 and T2 (p<0.05).,"['Fifty-one patients were included in the study and randomized into 2 groups: study group (n=26) included patients receiving', 'erosive oral lichen planus', 'erosive Oral Lichen Planus']","['conventional corticosteroid topical therapy (betamethasone soluble tablets', 'ozonized water treatment; control group', 'placebo treatment (i.e. double-distilled water', 'ozonized water']","['size of lesions, sign and pain scores', 'Candidiasis', 'sign and pain scores', 'Efficacy Index (EI) of treatment, candidiasis and relapse rates', 'relapse', 'Pain and size reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0406378', 'cui_str': 'Erosive oral lichen planus'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",51.0,0.0461569,Pain and size reduction were significantly higher in ozone-treated group both at T1 and T2 (p<0.05).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Veneri', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Bardellini', 'Affiliation': 'Dental Clinic, p.le Spedali Civili n.1 25133 Brescia elena.bardellini@unibs.it.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Amadori', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Majorana', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23693']
1159,32552472,Successful Outcomes of Newly Diagnosed T Lymphoblastic Lymphoma: Results From Children's Oncology Group AALL0434.,"PURPOSE


The Children's Oncology Group (COG) protocol AALL0434 evaluated the safety and efficacy of multi-agent chemotherapy with Capizzi-based methotrexate/pegaspargase (C-MTX) in patients with newly diagnosed pediatric T-cell lymphoblastic lymphoma (T-LL) and gained preliminary data using nelarabine in high-risk patients.
PATIENTS AND METHODS


The trial enrolled 299 patients, age 1-31 years. High-risk (HR) patients had ≥ 1% minimal detectable disease (MDD) in the bone marrow at diagnosis or received prior steroid treatment. Induction failure was defined as failure to achieve a partial response (PR) by the end of the 4-week induction. All patients received the augmented Berlin-Frankfurt-Muenster (ABFM) C-MTX regimen. HR patients were randomly assigned to receive or not receive 6 5-day courses of nelarabine incorporated into ABFM. Patients with induction failure were nonrandomly assigned to ABFM C-MTX plus nelarabine. No patients received prophylactic cranial radiation; however, patients with CNS3 disease (CSF WBC ≥ 5/μL with blasts or cranial nerve palsies, brain/eye involvement, or hypothalamic syndrome) were ineligible.
RESULTS


At end-induction, 98.8% of evaluable participants had at least a PR. The 4-year event-free survival (EFS) and overall survival (OS) were 84.7% ± 2.3% and 89.0% ± 2.0%. The 4-year disease-free survival (DFS) from end-induction was 85.9% ± 2.6%. There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55). Disease stage, tumor response, and MDD at diagnosis did not demonstrate thresholds that resulted in differences in EFS. Nelarabine did not show an advantage for HR patients. CNS relapse occurred in only 4 patients.
CONCLUSION


COG AALL0434 produced excellent outcomes in one of the largest trials ever conducted for patients with newly diagnosed T-LL. The COG ABFM regimen with C-MTX provided excellent EFS and OS without cranial radiation.",2020,There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55).,"['patients with newly diagnosed pediatric T-cell lymphoblastic lymphoma (T-LL) and gained preliminary data using nelarabine in high-risk patients', '299 patients, age 1-31 years', 'patients with CNS3 disease (CSF WBC', 'Patients with induction failure', 'HR patients', 'patients with newly diagnosed T-LL', 'Newly Diagnosed T Lymphoblastic Lymphoma']","['nelarabine incorporated into ABFM', 'COG AALL0434', 'Nelarabine', 'augmented Berlin-Frankfurt-Muenster (ABFM) C-MTX regimen', 'prophylactic cranial radiation', 'multi-agent chemotherapy with Capizzi-based methotrexate/pegaspargase (C-MTX', 'ABFM C-MTX plus nelarabine']","['4-year disease-free survival (DFS', '4-year event-free survival (EFS) and overall survival (OS', 'DFS', '≥ 5/μL with blasts or cranial nerve palsies, brain/eye involvement, or hypothalamic syndrome', 'partial response (PR', 'Induction failure', 'CNS relapse', 'Disease stage, tumor response, and MDD at diagnosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0855357', 'cui_str': 'CSF white blood cell count'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1292758', 'cui_str': 'Precursor T-cell lymphoblastic lymphoma'}]","[{'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0151311', 'cui_str': 'Cranial nerve paralysis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0442850', 'cui_str': 'Eye involvement'}, {'cui': 'C0751230', 'cui_str': 'Hypothalamic syndrome'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",299.0,0.0654142,There was no difference in DFS observed between the HR and standard-risk groups ( P  = .29) or by treatment regimen ( P  = .55).,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hayashi', 'Affiliation': ""Pediatric Hematology/Oncology, Washington School of Medicine, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Stuart S', 'Initials': 'SS', 'LastName': 'Winter', 'Affiliation': ""Children's Minnesota Cancer and Blood Disorders Program, Minneapolis, MN.""}, {'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Dunsmore', 'Affiliation': 'Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, VA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': ""Laboratory Medicine, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Hermiston', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Teachey', 'Affiliation': ""Division of Oncology, Department of Pediatrics, Center for Childhood Cancer Research, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Sherrie L', 'Initials': 'SL', 'LastName': 'Perkins', 'Affiliation': 'Department of Pathology, University of Utah Health Sciences Center, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT.'}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': 'Department of Pathology, University of Utah Health Sciences Center, ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Department of Pediatrics and Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Pediatric Hematology/Oncology, University of Texas Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Division of Oncology, Department of Pediatrics, Center for Childhood Cancer Research, Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Lim', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Hospital of Philadelphia, and The Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': 'National Cancer Institute Center for Global Health, Rockville, MD.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""Division of Blood and Marrow Transplantation, Children's National Health System, Washington, DC.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00531']
1160,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS


As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
1161,32555011,Effect of Tactile Experience During Preterm Infant Feeding on Clinical Outcomes.,"BACKGROUND


Although the survival rate of very preterm infants has improved, rates of subsequent neurobehavioral disabilities remain high. One factor implicated in poor neurobehavioral and developmental outcomes is hospitalization and inconsistent caregiving patterns in the neonatal intensive care unit. Although much underlying brain damage occurs in utero or shortly after birth, neuroprotective strategies may stop progression of damage, particularly when these strategies are used during the most sensitive periods of neural plasticity 2-3 months before term age.
OBJECTIVE


The purpose of this analysis was to test the effect of a patterned feeding experience involving a tactile component (touch and/or holding) provided during feedings on preterm infants' clinical outcomes, measured by oral feeding progress, as an early indicator of neurodevelopment.
METHODS


We used an experimental, longitudinal, two-group random assignment design. Preterm infants (n = 120) were enrolled within the first week of life and randomized to an experimental group receiving a patterned feeding experience or to a control group receiving usual feeding care.
RESULTS


Analysis of data from 91 infants showed that infants receiving touch at more than 25% of early gavage feedings achieved full oral feeding more quickly; as touch exposure increased, time from first oral to full oral feeding decreased. There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
DISCUSSION


Neurological expectation during critical periods of development is important for infants. However, a preterm infant's environment is not predictable: Caregivers change regularly, medical procedures dictate touch and holding, and care provision based on infant cues is limited. Current knowledge supports caregiving that occurs with a naturally occurring sensation (i.e., hunger), is provided in a manner that is congruent with the expectation of the neurological system, and occurs with enough regularity to enhance neuronal and synaptic development. In this study, we modeled an experience infants would ""expect"" if they were not in the neonatal intensive care unit and demonstrated a shorter time from first oral feeding to full oral feeding, an important clinical outcome with neurodevelopmental implications. We recommend further research to determine the effect of patterned caregiving experiences on other areas of neurodevelopment, particularly those that may occur later in life.",2020,"There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
",['Preterm infants (n = 120'],"['experimental group receiving a patterned feeding experience or to a control group receiving usual feeding care', 'Tactile Experience', 'patterned feeding experience involving a tactile component (touch and/or holding']",['survival rate'],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",120.0,0.0399053,"There was no association between holding during early gavage feedings or touch during transition feedings and time to full oral feeding.
","[{'ForeName': 'Rita H', 'Initials': 'RH', 'LastName': 'Pickler', 'Affiliation': ""Rita H. Pickler, PhD, RN, FAAN, is FloAnn Sours Easton Professor of Child and Adolescent Health, College of Nursing, The Ohio State University, Columbus. Jareen Meinzen-Derr, PhD, MPH, is Professor, Department of Pediatrics, University of Cincinnati College of Medicine, and Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Ohio. Margo Moore, MS, RN, is Research Nurse III, Division of Infectious Disease, Cincinnati Children's Hospital Medical Center, Ohio. Stephanie Sealschott, MS, RN, is PhD Candidate, College of Nursing, The Ohio State University, Columbus. Karin Tepe, BS, RN, is Research Nurse in Neonatology, Cincinnati Children's Hospital Medical Center, Ohio.""}, {'ForeName': 'Jareen', 'Initials': 'J', 'LastName': 'Meinzen-Derr', 'Affiliation': ''}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Sealschott', 'Affiliation': ''}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Tepe', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000453']
1162,32559794,Preoperative Fasting Abbreviation and its Effects on Postoperative Nausea and Vomiting Incidence in Gynecological Surgery Patients.,"OBJECTIVE


To investigate the effects of preoperative fasting abbreviation with a carbohydrate and protein-enriched solution, on postoperative nausea and vomiting (PONV) incidence in gynecological surgery patients, a population naturally at risk for such unpleasant episodes.
METHODS


The present prospective double-blind randomized study was performed at The Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP), approved by the Human Research Ethics Committee of UNIFESP and the board of HMMOLC, and included in the Brazil Platform and in the Brazilian Clinical Trial Registry. After signing the consent form, 80 women, who were submitted to gynecological surgery in the period from January to June 2016, were randomized into 2 groups: control group ( n  = 42) and juice group ( n  = 38). They received, respectively, 200 mL of inert solution or liquid enriched with carbohydrate and protein 4 hours presurgery. The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA).
RESULTS


The incidence of nausea and vomiting was lower than in the literature, to this population, with 18.9% (14/74) for the control group and 10.8% (8/74) for the juice group, respectively, with no statistically significant difference between the groups.
CONCLUSION


The incidence of nausea and vomiting was lower than in the literature, but it cannot be said that this is due to the abbreviation of fasting. It can provide greater comfort, with the possibility of PONV prevention in patients at risk for these episodes.",2020,"The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA).
","['Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP', '80 women, who were submitted to gynecological surgery in the period from January to June 2016', 'Gynecological Surgery Patients', 'gynecological surgery patients, a population naturally at risk for such unpleasant episodes']","['inert solution or liquid enriched with carbohydrate and protein 4\u2009hours presurgery', 'preoperative fasting abbreviation with a carbohydrate and protein-enriched solution', 'control group ( n \u2009=\u200942) and juice group']","['incidence, frequency and intensity of PONV', 'nausea and vomiting', 'Postoperative Nausea and Vomiting Incidence', 'Visual Analogue Scale (VAS', 'postoperative nausea and vomiting (PONV) incidence']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C1956259', 'cui_str': 'Acronyms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0587481', 'cui_str': 'Gynecology department'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0000723', 'cui_str': 'Abbreviation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0588202,"The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA).
","[{'ForeName': 'Gisele Vissoci', 'Initials': 'GV', 'LastName': 'Marquini', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Francisco Edes da Silva', 'Initials': 'FEDS', 'LastName': 'Pinheiro', 'Affiliation': 'Department of Gynecology, Hospital Municipal Maternidade Dr. Odelmo Leão Carneiro, Uberlândia, MG, Brazil.'}, {'ForeName': 'Alfredo Urbano da Costa', 'Initials': 'AUDC', 'LastName': 'Vieira', 'Affiliation': 'Department of Gynecology, Hospital Municipal Maternidade Dr. Odelmo Leão Carneiro, Uberlândia, MG, Brazil.'}, {'ForeName': 'Rogério Melo da Costa', 'Initials': 'RMDC', 'LastName': 'Pinto', 'Affiliation': 'Faculty of Mathematics, Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Maria Gabriela Baumgarten Kuster', 'Initials': 'MGBK', 'LastName': 'Uyeda', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Manoel João Batista Castello', 'Initials': 'MJBC', 'LastName': 'Girão', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Marair Gracio Ferreira', 'Initials': 'MGF', 'LastName': 'Sartori', 'Affiliation': 'Department of Gynecology, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}]",Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia,['10.1055/s-0040-1712994']
1163,32560970,Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial.,"OBJECTIVE


To compare the longer-term development outcomes in children born after freeze-only versus fresh embryo transfer (ET) in women with an ovulatory cycle.
DESIGN


Long-term follow-up study (NCT04099784) of babies born alive after the first ET in a randomized controlled trial (RCT) comparing ongoing pregnancy and live birth rates after use of a freeze-only versus fresh ET strategy (NCT02471573).
SETTING


Private clinic.
PATIENT(S)


Of 391 couples randomized to each treatment group in the RCT, 132 (97 singleton/35 twins) and 123 (95 singleton/28 twins) in the freeze-only and fresh ET groups had live birth; 113 parents (86%) from the freeze-only group (147 babies) and 99 (80%) from the fresh ET group (120 babies) returned questionnaires for this follow-up study.
INTERVENTION(S)


Use of a freeze-only or fresh ET strategy after controlled ovarian hyperstimulation with a follicle-stimulating hormone/gonadotropin-releasing antagonist protocol.
MAIN OUTCOME MEASURE(S)


Developmental status at ≥2 years after birth, determined using the Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires.
RESULT(S)


Mean age of children at the end of follow-up was 37 months. Height (95.0 ± 6.1 vs. 95.7 ± 5.6 cm) and weight (14.9 ± 2.6 vs. 14.8 ± 2.6 kg) were similar in the freeze-only and fresh ET groups (results were similar when singletons and twins were analyzed separately). Overall, ASQ-3 scores for problem solving were significantly better in the freeze-only versus fresh ET group (overall: 53.6 ± 8.4 vs. 51.1 ± 10.2), with no significant between-group difference when singletons (52.3 ± 10.1 vs. 51.0 ± 9.9) and twins (55.0 ± 5.5 vs. 51.4 ± 11.1) were analyzed separately. Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6). The overall proportion of children with abnormal ASQ-3 (6.8% vs. 8.3%) or abnormal Red Flags (5.4% vs. 6.7%) findings in the freeze-only and fresh ET groups was low and did not differ significantly between groups.
CONCLUSION(S)


These data provide physicians with additional information on which to base decisions about the relative merits of different approaches to infertility treatment. There do not appear to be any grounds for concern about worse outcomes after use of a freeze-only strategy. However, additional studies comparing childhood development after a freeze-only strategy, fresh ET, and natural cycles are needed before firm conclusions can be drawn.",2020,"Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6).","['children born after', 'women with an ovulatory cycle', 'children born from', '132 (97 singleton/35 twins) and 123 (95 singleton/28 twins) in the freeze-only and fresh ET groups had live birth; 113 parents (86%) from the freeze-only group (147 babies) and 99 (80%) from the fresh ET group (120 babies) returned questionnaires for this follow-up study', '391 couples randomized to each treatment group in the RCT', 'Private clinic', 'babies born alive after the first ET']","['freeze-only or fresh ET strategy', 'freeze-only versus fresh embryo transfer (ET', 'freeze-only versus fresh embryo transfer']","['Developmental Red Flags and Ages & Stages Third Edition (ASQ-3) Questionnaires', 'Fine motor skills scores', 'overall proportion of children with abnormal ASQ-3', 'abnormal Red Flags', 'Overall, ASQ-3 scores for problem solving']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]",391.0,0.0738169,"Fine motor skills scores were numerically higher (with P values approaching statistical significance) in the freeze-only versus fresh ET group in the overall analysis (47.8 ± 11.6 vs. 44.9 ± 12.6) and twins (49.85 ± 8.72 vs. 43.93 ± 12.71), but not singletons (46.0 ± 13.4 vs. 45.4 ± 12.6).","[{'ForeName': 'Lan Ngoc', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam; IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: lanvuong@ump.edu.vn.'}, {'ForeName': 'Trung Thien', 'Initials': 'TT', 'LastName': 'Ly', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nghia An', 'Initials': 'NA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Pediatrics, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Loc Minh Tai', 'Initials': 'LMT', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Xuyen Thi Ha', 'Initials': 'XTH', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tien Khac', 'Initials': 'TK', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Khanh Tuan Quoc', 'Initials': 'KTQ', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thanh Van', 'Initials': 'TV', 'LastName': 'Le', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Minh Hoang Nhat', 'Initials': 'MHN', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vinh Quang', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Adelaide, South Australia, Australia; Fertility SA, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ben Willem', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tuong Manh', 'Initials': 'TM', 'LastName': 'Ho', 'Affiliation': 'IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.04.041']
1164,32562721,Lower Adenoma Miss Rate of Computer-Aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy in a Prospective Tandem Study.,"BACKGROUND AND AIMS


Up to 30% of adenomas might be missed during screening colonoscopy-these could be polyps that appear on-screen but are not recognized by endoscopists or polyps that are in locations that do not appear on the screen at all. Computer-aided detection (CADe) systems, based on deep learning, might reduce rates of missed adenomas by displaying visual alerts that identify precancerous polyps on the endoscopy monitor in real time. We compared adenoma miss rates of CADe colonoscopy vs routine white-light colonoscopy.
METHODS


We performed a prospective study of patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019. Same day, tandem colonoscopies were performed for each participant by the same endoscopist. Patients were randomly assigned to groups that received either CADe colonoscopy (n=184) or routine colonoscopy (n=185) first, followed immediately by the other procedure. Endoscopists were blinded to the group each patient was assigned to until immediately before the start of each colonoscopy. Polyps that were missed by the CADe system but detected by endoscopists were classified as missed polyps. False polyps were those continuously traced by the CADe system but then determined not to be polyps by the endoscopists. The primary endpoint was adenoma miss rate, which was defined as the number of adenomas detected in the second-pass colonoscopy divided by the total number of adenomas detected in both passes.
RESULTS


The adenoma miss rate was significantly lower with CADe colonoscopy (13.89%; 95% CI, 8.24%-19.54%) than with routine colonoscopy (40.00%; 95% CI, 31.23%-48.77%, P<.0001). The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001). Adenoma miss rates in ascending, transverse, and descending colon were significantly lower with CADe colonoscopy than with routine colonoscopy (ascending colon 6.67% vs 39.13%; P=.0095; transverse colon 16.33% vs 45.16%; P=.0065; and descending colon 12.50% vs 40.91%, P=.0364).
CONCLUSIONS


CADe colonoscopy reduced the overall miss rate of adenomas by endoscopists using white-light endoscopy. Routine use of CADe might reduce the incidence of interval colon cancers. chictr.org.cn study no: ChiCTR1900023086.",2020,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[""patients, 18-75 years old, referred for diagnostic, screening, or surveillance colonoscopies at a single endoscopy center of Sichuan Provincial People's Hospital from June 3, 2019 through September 24, 2019""]","['CADe colonoscopy', 'Computer-aided Detection-Assisted Colonoscopy vs Routine White-Light Colonoscopy', 'CADe colonoscopy (n=184) or routine colonoscopy', 'CADe colonoscopy vs routine white-light colonoscopy', 'CADe']","['adenoma miss rate', 'Adenoma miss rates in ascending, transverse, and descending colon', 'incidence of interval colon cancers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0563228', 'cui_str': 'White light'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0227389', 'cui_str': 'Descending colon structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]",,0.0444084,"The polyp miss rate significantly lower with CADe colonoscopy (12.98%; 95% CI, 9.08%-16.88%) than with routine colonoscopy (45.90%; 95% CI, 39.65%-52.15%) (P<.0001).","[{'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Peixi', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Glissen Brown', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Berzin', 'Affiliation': 'Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Guanyu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Liangping', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Department of Gastroenterology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. Electronic address: xiaoxun001@outlook.com.""}]",Gastroenterology,['10.1053/j.gastro.2020.06.023']
1165,32568108,Carbidopa and Levodopa Extended Release Capsules in Patients with and without Troublesome and Non-Troublesome Dyskinesia.,"BACKGROUND


Carbidopa (CD) and levodopa (LD) extended release (CD-LD ER) capsules are designed to combine both immediate and extended release pharmacokinetics. In the phase 3, randomized, double-blind, ADVANCE-PD trial, patients randomized to CD-LD ER experienced a 1.17-hour greater reduction in OFF time compared to patients randomized to CD-LD IR (p < 0.0001).
OBJECTIVE


To compare CD-LD IR optimization to CD-LD ER conversion based on patient dyskinesia status at baseline using data from the ADVANCE-PD trial.
METHODS


This was a retrospective analysis of the ADVANCE-PD study. Patients were categorized by dyskinesia status at baseline into 1) those who had No Dyskinesia (ND), 2) those who had Non-Troublesome Dyskinesia Only (NTDO), and 3) those who had Troublesome Dyskinesia (TD).
RESULTS


Comparative reductions in OFF time favoring CD-LD ER over CD-LD IR were similar for the ND (-1.08 h, p = 0.0071, n = 183) and NTDO (-1.12 h, p = 0.0104, n = 131) groups, and smaller for the TD group (-0.82 h, p = 0.2382, n = 79). Reductions in OFF time for both CD-LD ER conversion and CD-LD IR adjustment were largest within the ND group and smallest within the TD group (CD-LD ER: ND -2.86 h, NTDO -2.11 h, TD -1.36 h; CD-LD IR: ND -1.78 h, NTDO -0.99 h, TD -0.55 h).
CONCLUSION


Responses to both CD-LD IR adjustment and CD-LD ER conversion depended on baseline dyskinesia status. Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups. In the TD group, comparing CD-LD ER conversion to CD-LD IR optimization, benefits were still observed, but there was less reduction in OFF time, less reduction in troublesome dyskinesia, and fewer patients self-rated themselves much or very much improved than in the ND and NTDO groups. These data suggest that in clinical practice, the best chances for success with conversion from CD-LD IR to CD-LD ER are in patients without TD.",2020,Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups.,"['Patients were categorized by dyskinesia status at baseline into 1) those who had No Dyskinesia (ND), 2) those who had Non-Troublesome Dyskinesia', 'Patients with and without Troublesome and Non-Troublesome Dyskinesia']","['CD-LD IR adjustment and CD-LD ER conversion', 'ND', 'Carbidopa (CD) and levodopa (LD) extended release (CD-LD ER, Rytary®) capsules', 'CD-LD IR optimization to CD-LD ER conversion', 'CD-LD ER', 'Carbidopa and Levodopa Extended Release Capsules (Rytary®']","['troublesome dyskinesia', 'CD-LD IR', 'OFF time', 'OFF time favoring CD-LD ER over CD-LD IR', 'Troublesome Dyskinesia (TD', 'OFF time for both CD-LD ER conversion and CD-LD IR adjustment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C3872096', 'cui_str': 'Rytary'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}]",,0.017814,Significant reductions in OFF time with CD-LD ER compared to CD-LD IR were observed in the ND and NTDO groups.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Zeitlin', 'Affiliation': 'Quartesian, Princeton, NJ, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'Amneal Pharmaceuticals, Bridgewater, NJ, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': ""D'Souza"", 'Affiliation': 'Amneal Pharmaceuticals, Bridgewater, NJ, USA.'}]",Journal of Parkinson's disease,['10.3233/JPD-202010']
1166,32564940,How to improve adherence the captors of phosphorus on hemodialysis: Experience in real life with sucroferric oxyhydroxide.,"INTRODUCTION


The lack of adherence to phosphate -binders (PB) is the most important factor in not achieving the objectives of serum phosphorus (sP). Studies in the real-world population are needed to understand the influence of PBs on adherence and how to modify it.
METHODS


Prospective study conducted during 3 months in usual clinical practice. Out of 105 hemodialysis patients, 57 were switched to SFOH and 48 maintained their baseline treatment (control group). sP levels and the percentage of patients with sP levels <5mg/dl were compared. Adherence before and after introduction of SFOH, number of pills of PB, preferences in the administration mode and side effects were analyzed.
RESULTS


The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS). The average of daily tablets decreased significantly in the SFOH group (7.2-2.3 comp, p<0.001), but not in the control group (5.6-5.6, p=NS) and 100% of the patients used only one PB in SFOH group. The use of SFOH increased the adherence according to the SMAQ questionnaire (57.8-84.3%; OR 13.1, p<0.001). The possibility to choose the preferred mode of administration (split-swallowing 89% compared to chewing 11%), improved the acceptance (44.7-78%). 14% of the patients experienced side effects and in 5.2% SFOH was discontinued for this reason.
CONCLUSIONS


SFOH controlled serum sP in 93% of patients, 100% in monotherapy, and with fewer tablets. The exploration and adaptation of preferences in the mode of administration influenced the acceptance of the drug by the patient and, probably, the future adherence.",2020,"The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS).","['Prospective study conducted during 3 months in usual clinical practice', '105 hemodialysis patients, 57 were switched to SFOH and 48 maintained their baseline treatment (control group']","['sucroferric oxyhydroxide', 'SFOH']","['sP levels', 'side effects', 'average of daily tablets', 'acceptance']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",105.0,0.0183717,"The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS).","[{'ForeName': 'M Dolores', 'Initials': 'MD', 'LastName': 'Arenas Jiménez', 'Affiliation': 'Nephrology Department, Hospital Vithas Perpetuo Internacional, Alicante, Spain; Nephrolgy Department, Hospital del Mar, Barcelona, Spain. Electronic address: lola@olemiswebs.com.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Navarro González', 'Affiliation': 'Nephrology Department, Hospital Universitario Nuestra Señora de la Candelaria, RedinRen, Santa Cruz de Tenerife, Spain.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.04.011']
1167,32572611,QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.,"BACKGROUND


Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life.
METHODS


At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores.
RESULTS


Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2).
CONCLUSIONS


Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.",2020,"RESULTS


Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery.",['after esophagectomy for cancer'],"['nutritional and respiratory counseling', 'nutritional counseling', 'QOLEC2', 'nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care']","['impairment in quality of life', 'Dyspnea', 'postoperative quality of life', 'mean score differences (MDs) in quality of life scores', 'appetite loss', 'Global quality of life']","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0621371,"RESULTS


Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery.","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Pinto', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Nardi', 'Affiliation': 'Nutritional Support Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Marchi', 'Affiliation': 'Respiratory Intensive Care Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Alfieri', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Saadeh', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cagol', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baldan', 'Affiliation': 'Nutritional Support Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Saraceni', 'Affiliation': 'Intensive Care Unit (ISTAR 2), Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Parotto', 'Affiliation': 'Intensive Care Unit, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Baratto', 'Affiliation': 'Intensive Care Unit (ISTAR 2), Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Caberlotto', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vianello', 'Affiliation': 'Respiratory Intensive Care Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Castoro', 'Affiliation': 'Department. of Upper GI Surgery, Humanitas Research Hospital-Humanitas University, Rozzano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scarpa', 'Affiliation': 'General Surgery Unit, Azienda Ospedaliera di Padova, Padua, Italy. marcoscarpa73@yahoo.it.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05573-z']
1168,32569284,A biofeedback-enhanced therapeutic exercise video game intervention for young people with cerebral palsy: A randomized single-case experimental design feasibility study.,"IMPORTANCE/BACKGROUND


Movement-controlled video games have potential to promote home-based practice of therapy activities. The success of therapy gaming interventions depends on the quality of the technology used and the presence of effective support structures.
AIM


This study assesses the feasibility of a novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC) strategies to support therapy engagement and efficacy at home.
METHODS


Following feasibility and single-case reporting standards (CONSORT and SCRIBE), this was a non-blind, randomized, multiple-baseline, AB, design. Nineteen (19) young people with cerebral palsy (8-18 years old) completed the 4-week home-based intervention in France and Canada. Participant motivations, personalized practice goals, and relevance of the intervention to daily activities were discussed in a Solution Focused Coaching-style conversation pre-, post-intervention and during weekly check-ins. Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software). Process feasibility success criteria for recruitment response, completion and adherence rates, and frequency of technical issues were established a priori. Scientific feasibility, effect size estimates and variance were determined for Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS).
RESULTS


Recruitment response (31%) and assessment completion (84%) rates were good and 74% of participants reached self-identified practice goals. As 17% of technical issues required external support to resolve, the intervention was graded as feasible with modifications. No adverse events were reported. Moderate effects were observed in Body Function measures (active wrist extension: SMD = 1.82, 95%CI = 0.85-2.78; Grip Strength: SMD = 0.63, 95%CI = 0.65-1.91; Box and Blocks: Hedge's g = 0.58, 95%CI = -0.11-1.27) and small-moderate effects in Activities and Participation measures (AHA: Hedge's g = 0.29, 95%CI = -0.39-0.97, COPM: r = 0.60, 95%CI = 0.13-0.82, SEAS: r = 0.24, 95%CI = -0.25-0.61).
CONCLUSION


A definitive RCT to investigate the effectiveness of this novel intervention is warranted. Combining SFC-style coaching with high-quality biofeedback may positively engage youth in home rehabilitation to complement traditional therapy.
TRIAL REGISTRATION


ClinicalTrials.gov, U.S. National Library of Medicine: NCT03677193.",2020,"Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software).","['Nineteen (19) young people with cerebral palsy (8-18 years old', 'young people with cerebral palsy']","['novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC', 'single-case reporting standards (CONSORT and SCRIBE', 'biofeedback-enhanced therapeutic exercise video game intervention', 'SFC-style coaching with high-quality biofeedback', '4-week home-based intervention in France and Canada', 'video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software']","['adverse events', 'Body Function measures', 'Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0932629,"Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'MacIntosh', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Desailly', 'Affiliation': 'Recherche et innovation, Fondation Ellen Poidatz, Saint Fargeau-Ponthierry, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vignais', 'Affiliation': 'Complexité, Innovation, Activités Motrices et Sportives, Sciences du Sport, de la Motricité et du Mouvement Humain, Université Paris-Saclay, Orsay, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vigneron', 'Affiliation': ""Informatique, Bio-informatique et Systèmes Complexes, l'Université d'Evry Val-d'Essonne, Evry, France.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Biddiss', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}]",PloS one,['10.1371/journal.pone.0234767']
1169,32583982,The Effects of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Chronic Knee Pain in Older U.S. Adults: Results from a Randomized Trial.,"OBJECTIVE


Knee pain from osteoarthritis is frequent in the adult population. Prior trials have had conflicting results concerning vitamin D's therapeutic effects on knee pain and few trials have investigated marine omega-3 fatty acids (n-3 FA).
METHODS


The double-blind, placebo-controlled VITamin D and OmegA-3 TriaL (VITAL) randomized 25,871 U.S. adults in a two-by-two factorial design to vitamin D and n-3 FA. We identified a subgroup with chronic knee pain prior to randomization and assessed knee pain at baseline and annually during follow-up with the Western Ontario and McMaster Universities Arthritis Index (WOMAC; 0-100, 100 worst). Repeated measures modeling tested the effect of randomized treatment on WOMAC Pain over follow-up after adjustment for age and sex. Analyses were repeated for WOMAC Function and Stiffness.
RESULTS


We included 1,398 participants who returned at least one knee pain questionnaire. Mean age was 67.7 years, 66% were female, and mean WOMAC Pain was 37 (SD 19). Mean follow-up time was 5.3 years (SD 0.7). WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up. Linear time by treatment interactions were not statistically significant for either treatment (vitamin D p= 0.41, n-3 FA p= 0.77). Vitamin D and n-3 FA supplementation did not significantly affect WOMAC Function or Stiffness scores over time.
CONCLUSION


Vitamin D and n-3 FA supplementation for a mean of 5.3 years did not reduce knee pain or improve function or stiffness in a large sample of U.S adults with chronic knee pain.",2020,WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up.,"['1,398 participants who returned at least one knee pain questionnaire', 'subgroup with chronic knee pain prior to randomization and assessed knee pain at baseline and annually during follow-up with the Western Ontario and McMaster Universities Arthritis Index', 'adults with chronic knee pain', 'Older U.S. Adults', 'Mean age was 67.7 years, 66% were female, and mean WOMAC Pain was 37 (SD 19']","['vitamin D and n-3 FA', 'Vitamin D and n-3 FA supplementation', 'placebo-controlled VITamin D and OmegA-3 TriaL', 'vitamin D or n-3 FA and placebo', 'Vitamin D and Marine Omega-3 Fatty Acid Supplementation']","['knee pain', 'Chronic Knee Pain', 'WOMAC Function or Stiffness scores', 'WOMAC Function and Stiffness', 'WOMAC Pain']","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",25871.0,0.401195,WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up.,"[{'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'MacFarlane', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maura D', 'Initials': 'MD', 'LastName': 'Iversen', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41416']
1170,32444994,"""BAX602"" in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial.","BACKGROUND


The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. The present study aims to evaluate the safety and effectiveness of BAX602 spray in patients undergoing extracorporeal ventricular assist device implantation surgery to treat refractory congestive heart failure.
METHODS AND DESIGN


This investigator-initiated, multicenter, pivotal, two-arm, open-label, randomized trial will include a total of 30 patients. The primary outcome measure is the severity of adhesions, which will be evaluated during re-sternotomy surgery performed 2-12 weeks after the primary extracorporeal ventricular assist device implantation surgery. The adhesion severity will be evaluated at five predefined sites using a four-grade adhesion evaluation score (0 = no adhesion; 1 = filmy and avascular adhesion; 2 = dense/vascular adhesion; 3 = cohesive adhesion). This measure will be summarized in two ways to evaluate the effect of BAX602: (1) the total score of the severity of adhesions at all five sites (ranging from 0 to 15), and (2) the total number of sites with dense/vascular or cohesive adhesions (ranging from 0 to 5).
ETHICS AND DISSEMINATION


The study findings will be disseminated at regional, national, and international conferences and through peer-reviewed scientific journals.
TRIAL REGISTRATION


The trial was registered in the UMIN Clinical Trials Registry (UMIN-CTR: UMIN000038998) on 6 January 2020.",2020,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"['Refractory Congestive Heart Failure', '30 patients', 'patients undergoing']","['Extracorporeal Ventricular Assist Device Implantation', 'BAX602 spray', 'BAX602', 'extracorporeal ventricular assist device implantation surgery']","['safety and effectiveness', 'severity of adhesions, which will be evaluated during re-sternotomy surgery', 'adhesion severity']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0397128', 'cui_str': 'Implantation of ventricular assist device'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.202345,Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery.,"[{'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Fukushima', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan. s.fukushima@ncvc.go.jp.'}, {'ForeName': 'Koko', 'Initials': 'K', 'LastName': 'Asakura', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Hamasaki', 'Affiliation': 'The Biostatistics Center and Department of Biostatistics and Bioinformatics, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Onda', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shiose', 'Affiliation': 'Department of Cardiovascular Surgery, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiac Surgery, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Norihide', 'Initials': 'N', 'LastName': 'Fukushima', 'Affiliation': 'Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Data Science, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 6-1 Kishibeshimmachi, Suita, Osaka, 564-8565, Japan.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06990-2']
1171,32545534,"Self-Regulation in Children with Neurodevelopmental Disorders ""SR-MRehab: Un Colegio Emocionante"": A Protocol Study.","Self-regulation refers to the ability to control and modulate behavior, and it can include both emotional and cognitive modulation. Children with neurodevelopmental disorders may show difficulties in self-regulation. The main objective of this study is to improve self-regulation skills in children between 6 and 11 years of age with neurodevelopmental disorders. Methodology: A randomized controlled trial will be conducted with the use of ""SR-MRehab: Un colegio emocionante"", based on a non-immersive virtual reality system where virtual objects can be managed by children in a natural way using their hands. Children will be recruited from several schools of Granada (Spain) and they will be randomly allocated to two groups. An assessment will be conducted before and after the intervention and 24 weeks after the end of the intervention process. The experimental group will receive the intervention using virtual reality. The control group will receive a standard self-regulation program. Both interventions will be performed once a week for a total of 10 sessions. Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated. The results will be published and will provide evidence regarding the use of this type of intervention in children with neurodevelopmental disorders. Trial registration: Registered with code NCT04418921.",2020,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","['children with neurodevelopmental disorders', 'Children with neurodevelopmental disorders', 'children between 6 and 11 years of age with neurodevelopmental disorders', 'Children with Neurodevelopmental Disorders', 'Children will be recruited from several schools of Granada (Spain']","['standard self-regulation program', 'SR-MRehab', 'Methodology']",['self-regulation skills'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.0449342,"Changes in self-regulation, as well as the acceptability of technology with the use of SR-MRehab, will be evaluated.","[{'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Romero-Ayuso', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alcántara-Vázquez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Almenara-García', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nuñez-Camarero', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José Matías', 'Initials': 'JM', 'LastName': 'Triviño-Juárez', 'Affiliation': 'Primary Care Center Zaidín Sur, Granada Metropolitan Sanitary District, 18007 Granada, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Ariza-Vega', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy Division, Faculty of Health Sciences, University of Granada, Avda. De la Ilustración nº60, 18016 Granada, Spain.'}, {'ForeName': 'José-Pascual', 'Initials': 'JP', 'LastName': 'Molina', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'González', 'Affiliation': 'LoUISE Research Group, Computing Systems Department, University of Castilla-La Mancha, 02071 Albacete, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124198']
1172,32545539,"Identifying Social Network Conditions that Facilitate Sedentary Behavior Change: The Benefit of Being a ""Bridge"" in a Group-based Intervention.","Using data from one of the first trials to try to leverage social networks as a mechanism for obesity intervention, we examined which social network conditions amplified behavior change. Data were collected as part of a community-based healthy lifestyle intervention in Nashville, USA, between June 2014 and July 2017. Adults randomized to the intervention arm were assigned to a small group of 10 participants that met in person for 12 weekly sessions. Intervention small group social networks were measured three times; sedentary behavior was measured by accelerometry at baseline and 12 months. Multivariate hidden Markov models classified people into distinct social network trajectories over time, based on the structure of the emergent network and where the individual was embedded. A multilevel regression analysis assessed the relationship between network trajectory and sedentary behavior (N = 261). Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04]. Certain social network conditions may make it easier to reduce adult sedentary behavior in group-based interventions. While further research will be necessary to establish causality, the implications for intervention design are discussed.",2020,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].",[],[],[],[],[],[],,0.0215047,"Being a person that connected clusters of intervention participants at any point during the intervention predicted an average reduction of 31.3 min/day of sedentary behavior at 12 months, versus being isolated [95% CI: (-61.4, -1.07),  p  = 0.04].","[{'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'de la Haye', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA 90007, USA.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Santiago J', 'Initials': 'SJ', 'LastName': 'Saldana', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Division of Academic General Pediatrics, Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Ip', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17124197']
1173,32557974,Association between biomarkers and house dust mite sublingual immunotherapy in allergic asthma.,"BACKGROUND


House dust mite (HDM) sublingual immunotherapy (SLIT) has demonstrated efficacy in clinical trials of patients with asthma. Airway inflammation is a characteristic of respiratory allergy, but its relationship to SLIT remains unclear.
OBJECTIVE


We evaluate the association between clinical outcomes with pulmonary function and biomarkers in before and after HDM SLIT (UMIN Number 000022390).
METHODS


One hundred twelve patients with asthma sensitized to HDM were randomized to add-on 6 standardized quality (SQ)-HDM SLIT to pharmacotherapy or pharmacotherapy alone for 48 weeks. At baseline and end of study, biomarkers, blood eosinophils, serum IgE, serum periostin, fractional exhaled nitric oxide (FeNO), and spirometry and clinical symptoms were measured. Association between biomarkers and an increase in FEV 1  of 120 mL or greater were analysed.
RESULTS


Sublingual immunotherapy (SLIT) demonstrated a significant reduction of serum periostin (P < .001), FeNO (P < .01), and increase in HDM-specific IgE (P < .05), FEV 1  (P < .001) and improvement of clinical symptom scores, when compared to pharmacotherapy. The change in FEV 1  correlated with the changes in serum periostin (r = .696, P < .001) and the changes in FeNO (r = .682, P < .001). The independent predictor of improvement in airflow limitation was changed in serum periostin (r 2   = .753, P = .013) and FeNO (P = .038). Based on cut-off values derived by receiver operating characteristic analysis (periostin 30.9 ng/mL, FeNO 28.0 ppb), patients were distinguished responders from non-responders, but with no predictive value for blood eosinophils or total IgE. The proportion of patients with both high periostin and FeNO levels was significantly higher in responder than in non-responder (P = .026).
CONCLUSIONS AND CLINICAL RELEVANCE


Adding HDM SLIT to pharmacotherapy resulted in reduced serum periostin and FeNO, and improved pulmonary function. Serum periostin and FeNO may be useful biomarkers for prediction of SLIT.",2020,"The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038).","['patients with asthma', 'One hundred twelve patients with asthma sensitized to HDM', 'allergic asthma']","['standardized quality (SQ)-HDM SLIT to pharmacotherapy or pharmacotherapy alone', 'House dust mite (HDM) sublingual immunotherapy (SLIT']","['airflow limitation', 'HDM specific IgE', 'clinical symptom scores', 'serum periostin and FeNO, and improved pulmonary function', 'FeNO levels', 'changes in FeNO', 'serum periostin', 'FeNO', 'blood eosinophils or total IgE', 'biomarkers, blood eosinophils, serum IgE, serum periostin, fractional exhaled nitric oxide (FeNO), and spirometry and clinical symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1270515', 'cui_str': 'House dust mite (Bt) specific immunoglobulin E'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}]",112.0,0.0433362,"The independent predictor of improvement in airflow limitation were change in serum periostin (r 2  = 0.753, P = 0.013) and FeNO (P = 0.038).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Division of Clinical Allergy, Department of Internal Medicine, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Akitsu', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Ohtawa', 'Affiliation': 'Department of Radiology, Atami Hospital, International University of Health and Welfare, Atami, Japan.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13686']
1174,32554365,Comparison of efficacy between combined periarticular and incisional injections versus periarticular injection alone of bupivacaine for pain control after total knee arthroplasty: A prospective randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the efficacy of combined periarticular and incisional injections versus periarticular injection alone of bupivacaine in reducing post-operative pain after total knee arthroplasty (TKA).
METHODS


In this prospective, randomized, double-blind comparative study, 90 patients with primary osteoarthritis who underwent TKA were enrolled. The patients were then randomly divided into 3 groups (30 in each): group 1, without injection; group 2, with periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl (50 mg) before wound closure. Post-operative pain levels were measured using a 100-mm visual analogue scale (VAS) (0 mm: no pain and 100 mm: worst pain) at 30 min and 1, 2, 4, and 6 h, post-operatively.
RESULTS


The mean VAS score in group 3 (the combined group-periarticular and incisional injections) within the first 4 h was lower than that in group 1 and group 2 (p<0.001). The mean VAS scores at the first 30 min were 65.21±9.46 in group 1, 51.86±5.96 in group 2, and 29.33±8.55 in group 3 (p<0.001). The mean VAS scores at the first 1 h were 64.43±9.32 in group 1, 47.26±4.77 in group 2, and 31.66±7.37 in group 3 (p<0.001). The mean scores at the 2 h were 61.46±8.62 in group 1, 48.33±4.66 in group 2, and 30.83±6.76 in group 3 (p<0.001). The mean scores at the 4 h were 64.72±8.91 in group 1, 47.53±4.35 in group 2, and 34.36±6.64 in group 3 (p<0.001). The differences were not significant at 6 h between group 2 (44.91±4.12) and group 3 (41.83±6.71) (p>0.001). However, the values were significantly lower than those of the control group (63.56±9.73) (p<0.001). In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
CONCLUSION


Evidence from this study revealed that the combined injection of bupivacaine is more effective than its periarticular injection alone and provides effective post-operative pain management after TKA.
LEVEL OF EVIDENCE


Level I, Therapeutic study.",2020,"In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
","['90 patients with primary osteoarthritis who underwent TKA were enrolled', 'pain control after total knee arthroplasty', 'after total knee arthroplasty (TKA']","['combined periarticular and incisional injections versus periarticular injection alone of bupivacaine', 'periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl', 'bupivacaine']","['mean scores', '100-mm visual analogue scale (VAS', 'Post-operative pain levels', 'mean VAS scores', 'post-operative pain', 'mean VAS score', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",90.0,0.0690695,"In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Sarıkaya', 'Affiliation': 'Department of Orthopedics and Traumatology, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Mahmut Alp', 'Initials': 'MA', 'LastName': 'Karahan', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Büyükfırat', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Binici', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Ertürk', 'Affiliation': 'Deparment of Orthopedics and Traumatology, Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Altay', 'Affiliation': 'Department of Orthopedics and Traumatology, Harran University, School of Medicine, Şanlıurfa, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.20212']
1175,32683384,Effect of lingual-based flap design on postoperative pain of impacted mandibular third molar surgery: Split-mouth randomized clinical trial.,"BACKGROUND


The extraction of third molars is one of the most common procedures in oral and maxillofacial surgery clinic. Surgical extraction involves the manipulation of both soft and hard tissues, so the patient usually experiences pain, swelling, and trismus in the immediate post-operative period. Several studies have been conducted using different types of surgical flaps to provide access with the least possible damage of soft tissues. Designing and implementing an optimum flap, which provides easier technique, better visibility, minimal post-operative complications, and best healing, is an aspired goal of every oral surgeon. This study aimed to compare lingual-based four-cornered flap with conventional triangular flap, and to evaluate its effect on post-operative pain after surgical extraction of impacted lower third molars.
MATERIAL AND METHODS


Seventeen patients (age ranged from 19 to 26 years) with bilateral, symmetrical impacted lower third molars (n=34) were included in the study. This was a randomized clinical trial with a split-mouth design. The impacted molars were assigned randomly, by coin flipping, to two groups: Case side with lingual-based four-cornered flap (Group A), and control side with conventional triangular flap (Group B). Away from the incision, the prognosis, surgical intervention, and postoperative procedures were exactly the same for the two groups. Postsurgical pain was assessed for 5 days using visual analogue scale (VAS) and by recording patients need for analgesics on a daily basis. Patients were also evaluated via a self-reporting questionnaire, i.e. Postoperative Symptoms Severity (PoSSe) scale, administered on the seventh postoperative day.
RESULTS


Pain scores recorded in Group A were found to be significantly lower as compared to pain scores in Group B in the 5 postoperative days (P<0.05). Total analgesic intake in Group B was significantly higher (P<0.05). PoSSe scores were lower in Group A, however, this difference was insignificant (P>0.05).
CONCLUSIONS


According to the data of the current study and within its limits, it appeared that lingual-based four-cornered flap design was superior to the conventional triangular flap regarding the postsurgical discomfort and pain.",2020,Total analgesic intake in Group B was significantly higher (P<0.05).,"['Seventeen patients (age ranged from 19 to 26 years) with bilateral, symmetrical impacted lower third molars (n=34) were included in the study', 'postoperative pain of impacted mandibular third molar surgery']","['Case side with lingual-based four-cornered flap (Group A), and control side with conventional triangular flap', 'lingual-based flap design', 'lingual-based four-cornered flap with conventional triangular flap']","['pain scores', 'Total analgesic intake', 'PoSSe scores', 'visual analogue scale (VAS', 'Postsurgical pain', 'self-reporting questionnaire, i.e. Postoperative Symptoms Severity (PoSSe) scale', 'Pain scores']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",34.0,0.119895,Total analgesic intake in Group B was significantly higher (P<0.05).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hassan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery Faculty of Dentistry, Syrian Private University P.O. Box 36822, Damascus, Syria nuraldeen.alkhanati@gmail.com.'}, {'ForeName': 'N-M', 'Initials': 'NM', 'LastName': 'Al-Khanati', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bahhah', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23666']
1176,32683388,Hemostatic agents in endodontic surgery of maxillary molars: A randomized controlled pilot study of polytetrafluoroethylene (PTFE) strips as an adjunct to epinephrine impregnated gauze versus aluminum chloride.,"BACKGROUND


Hemostasis is of critical importance in endodontic surgery. Studies on bleeding control in maxillary molars are scarce. The present study compares the efficacy of two hemostatic techniques in controlling bleeding in endodontic surgery.
MATERIAL AND METHODS


A randomized two-arm pilot study involving 30 patients with peri-radicular lesions in maxillary molars (first and second molars) was carried out including the following hemostatic agents: polytetrafluoroethylene (PTFE) strips as an adjunct to epinephrine impregnated gauze (test group; n = 15) and aluminum chloride (Expasyl™) (control; n = 15). Bleeding control was independently assessed by the surgeon and by two blinded observers before and after application of the hemostatic agent, and was classified as either adequate (complete bleeding control) or inadequate (incomplete bleeding control).
RESULTS


Bleeding control was similar in both groups. Simple binary logistic regression analysis failed to identify variables affecting bleeding control. Only the height of the keratinized mucosal band (≥ 2 mm) suggested a decreased risk of inadequate bleeding control of up to 89% (OR=0.11; p=0.06).
CONCLUSIONS


No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.",2020,No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.,"['30 patients with peri-radicular lesions in maxillary molars (first and second molars', 'endodontic surgery of maxillary molars']","['epinephrine impregnated gauze (test group; n = 15) and aluminum chloride (Expasyl™', 'polytetrafluoroethylene (PTFE) strips', 'epinephrine impregnated gauze and aluminum chloride', 'Hemostatic agents', 'hemostatic agents: polytetrafluoroethylene (PTFE) strips', 'hemostatic techniques', 'epinephrine impregnated gauze versus aluminum chloride']","['Bleeding control', 'efficacy of bleeding control', 'risk of inadequate bleeding control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0019120', 'cui_str': 'Hemostatic agent'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0051512', 'cui_str': 'Aluminum chloride hexahydrate'}, {'cui': 'C0019119', 'cui_str': 'Hemostatic Technics'}]","[{'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",30.0,0.0325652,No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Soto-Peñaloza', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cervera-Ballester', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cabanes-Gumbau', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23652']
1177,32560069,Effects of a Physical Education Intervention on Academic Performance: A Cluster Randomised Controlled Trial.,"BACKGROUND


We investigated the effects of three different interventions on academic performance in students enrolled in the first year of high school.
METHODS


This was a cluster randomised controlled trial conducted with 1200 students enrolled in the first year of high school. Schools were randomly assigned to: 1. Doubling physical education (PE) classes (3:20 h of PE/week); 2. workshop with the PE teachers; 3. workshop with the PE teachers and doubling the PE classes; and 4. control group (1:40 h of PE/week). We assured that the schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom.
RESULTS


Overall, the intervention was not effective in improving the students' academic performance. However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
CONCLUSIONS


Enhancing the pedagogical skills of the teachers is a promising approach in improving the academic performance of students who failed an academic year.",2020,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","['1200 students enrolled in the first year of high school', 'students enrolled in the first year of high school', 'schools within the groups were equal regarding: The structural condition of the sports court; number of PE teachers; number of school classes; and the average number of students per classroom', 'students who failed an academic year']","['workshop intervention', 'Physical Education Intervention']","[""students' academic performance"", 'academic performance', 'Doubling physical education (PE) classes', 'Academic Performance']","[{'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0456387', 'cui_str': 'Class'}]",1200.0,0.0519151,"However, the subgroup analysis showed that the workshop intervention group increased the academic performance of students who had failed an academic year (from 16 years of age), compared to their peers in the doubling the PE classes (1.3 points on average) and the control groups (1.4 points on average).
","[{'ForeName': 'Rodrigo Antunes', 'Initials': 'RA', 'LastName': 'Lima', 'Affiliation': 'Institute of Sport Science, University of Graz, Mozartgasse 14, 8010 Graz, Austria.'}, {'ForeName': 'Fernanda Cunha', 'Initials': 'FC', 'LastName': 'Soares', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bezerra', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}, {'ForeName': 'Mauro Virgílio Gomes', 'Initials': 'MVG', 'LastName': 'de Barros', 'Affiliation': 'Research Group on Lifestyles and Health, University of Pernambuco, Arnóbio Marquês Street, 310, Recife 50100-130, PE, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17124287']
1178,32561426,Recombinant human thrombopoietin in critically ill patients with sepsis-associated thrombocytopenia: A clinical study.,"BACKGROUND


Sepsis causes varying degrees of thrombocytopenia that are closely related to the likelihood of patient mortality. This study analysed the effect of recombinant human thrombopoietin (rhTPO) on the platelet count in critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment.
MATERIAL/METHODS


The study was a retrospective analysis of the clinical data of patients. Patients were divided into an rhTPO group and control group according to rhTPO use during treatment. Demographical and clinical data (age, sex, history of hypertension, diabetes, platelet counts, mortality rate, etc.) of the patients were collected and analysed using statistical software; p < 0.05 was considered statistically significant.
RESULTS


Of 213 patients, 84 constituted the rhTPO group and 129 constituted the control group. The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01 ± 18.23 × 10 9 /L vs. 36.31 ± 14.17 × 10 9 /L, p = 0.003), fifth day (71.51 ± 39.59 × 10 9 /L vs. 42.95 ± 20.48 × 10 9 /L, p < 0.001) and seventh day (115.36 ± 69.41 × 10 9 /L vs. 62.54 ± 42.70 × 10 9 /L, p < 0.001). Further statistical analysis of the data of patients with platelet counts ≤30 × 10 9 /L and >30 × 10 9 /L and APACHE II scores >15 and ≤15 at the time of diagnosis showed that the increase in platelet counts in the rhTPO group was greater. There was no significant between-group difference in volume of platelet transfusions (rhTPO group 15.42 ± 17.20 vs. control group 10.93 ± 17.48, p = 0.068). The cost of ICU treatment in patients with rhTPO was higher (RMB 126,936.21 ± 86,548.27 vs. 101,685.28 ± 77,291.75, p = 0.027); however, the ICU stay time was shorter (9.20 ± 5.38 vs. 10.88 ± 6.82, p = 0.047). There was no significant difference in 28-day mortality (rhTPO group: 25.0% vs. control group: 34.1%, p = 0.158) between the two groups.
CONCLUSION


For patients with severe thrombocytopenia or severe sepsis, rhTPO was efficacious in increasing their platelet counts, resulting in a shorter ICU stay time.",2020,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"['patients with severe thrombocytopenia or patients with severe sepsis', 'patients with platelet counts', 'critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment', '213 patients', '84 patients constituted the rhTPO group and 129 constituted the control group', 'critically ill patients with sepsis-associated thrombocytopenia', '≤30×10 9']","['recombinant human thrombopoietin (rhTPO', 'Recombinant human thrombopoietin', 'rhTPO']","['ICU stay time', 'platelet counts', 'volume of platelet transfusions', 'cost of ICU treatment', '28-days mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",213.0,0.0258731,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': ""Emergency Department, Xi'an Aerospace General Hospital, Xi'an, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: wangxuejd2008@126.com.""}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: glt2002@xjtu.edu.cn.""}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.045']
1179,32567518,A Clustered Randomized Trial Informing Patients on Dialysis About Their Ability to Donate Organs and Tissues.,"INTRODUCTION


The transplant waiting list exceeds the number of organs available. One means of increasing the organ pool is to broaden potential donors to include those with chronic diseases.
RESEARCH QUESTIONS


The study tested the effectiveness of using peer mentors to encourage individuals on dialysis to enroll on an organ donor registry.
DESIGN


Dialysis units were pair-matched by size and racial composition and then randomized to one of 2 interventions: meetings with a peer mentor (experimental intervention) or organ donation mailings (control). Peer mentors were trained to discuss organ donation with individuals on dialysis during in-person meetings at dialysis units. The primary outcome was verified registration in the state's donor registry.
RESULTS


After adjusting for age, gender, race, income, and education and accounting for correlation within the dialysis center, there was a significant intervention effect. Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
DISCUSSION


The use of peer mentors to discuss donating organs after death with individuals on dialysis can increase enrollment on a donor registry. Dispelling myths about chronic illness and donation can counter widely held misconceptions and help persons make an informed choice about end-of-life decisions and present an opportunity to increase the number of organs and tissues available for transplant.",2020,"Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
",[],['peer mentor (experimental intervention) or organ donation mailings (control'],"[""verified registration in the state's donor registry""]",[],"[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]",,0.028342,"Among individuals in the intervention group, the odds of enrolling (verified) on the donor registry were 2.52 times higher than those in the control group.
","[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Andrews', 'Affiliation': '456953National Kidney Foundation of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': ""Division of Biostatistics and Epidemiology, 2518Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Allyce Haney', 'Initials': 'AH', 'LastName': 'Smith', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Loughery', 'Affiliation': '456953National Kidney Foundation of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, 51329University of Michigan School of Public Health, Ann Arbor, MI, USA.'}, {'ForeName': 'Remonia', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Gift of Life Michigan, Minority Organ and Tissue Transplant Education Program, Ann Arbor, MI, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Jenkins Riley', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Stav', 'Affiliation': 'Greenfield Health Systems, Bingham Farms, MI, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Yee', 'Affiliation': '2971Henry Ford Health System, Detroit, MI, USA.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.1177/1526924820933840']
1180,32567544,Acute effects of sitagliptin on progenitor cells and soluble mediators in newly diagnosed type 2 diabetes.,"OBJECTIVE


Studies have confirmed that endothelial progenitor cells (EPCs) are involved in diabetic complications. The present study assessed the action of the dipeptidyl peptidase-4 inhibitor sitagliptin on EPCs in newly diagnosed type 2 diabetes patients.
MATERIALS AND METHODS


60 newly-diagnosed type 2 diabetes patients were randomly divided into three treatment groups: sitagliptin (n = 20), metformin (n = 20), and combination sitagliptin and metformin (n = 20). Patients were treated once daily for 3 days. Before and after each treatment, the number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α)) were determined.
RESULTS


The number of CD34 + KDR +  and CD34 + CD133 + KDR +  EPCs and concentration of GLP-1, NO, and SDF-1α in sitagliptin and combination groups were both increased (both p < 0.05) but to a greater extent in the combination group (p < 0.05). Pearson correlation analysis and multiple linear regression analyses showed that the change in EPC numbers correlated with changes in peripheral GLP-1, NO, and SDF-1α levels (p < 0.05).
CONCLUSION


Sitagliptin is able to directly increase the number of peripheral blood EPCs. This direct effect is to be important for lowering vascular risk in early diabetes before macrovascular complications appear.",2020,"Before and after each treatment, the number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α)) were determined.
","['60', 'newly diagnosed type 2 diabetes patients', 'newly-diagnosed type 2 diabetes patients', 'newly diagnosed type 2 diabetes\u2029']","['sitagliptin', 'dipeptidyl peptidase-4 inhibitor sitagliptin', 'metformin', 'combination sitagliptin and metformin']","['number of peripheral blood EPCs', 'peripheral GLP-1, NO, and SDF-1α levels', 'number of CD34+KDR+ and CD34+CD133+KDR+ EPCs and concentration of GLP-1, NO, and SDF-1α', 'number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}]",60.0,0.0215393,"Before and after each treatment, the number of EPCs and concentration of soluble mediators (glucagon-like peptide 1 (GLP-1), nitric oxide (NO), endothelin-1 (ET-1), and stromal cell-derived factor-1α (SDF-1α)) were determined.
","[{'ForeName': 'Murong', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Datong', 'Initials': 'D', 'LastName': 'Deng', 'Affiliation': ''}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Youmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': ''}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203665']
1181,32563787,Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis.,"OBJECTIVES


The role of topical anti-infectives in acute exacerbations of chronic rhinosinusitis is controversial. Povidone-iodine is an anti-bacterial and anti-viral that is affordable and available over-the-counter and may demonstrate advantages over mupirocin as a sinus irrigation therapy. The objective was to compare povidone-iodine or mupirocin versus saline sinus irrigations for sinusitis exacerbations in post-surgery subjects as well as to assess tolerability of povidone-iodine sinus irrigations.
MATERIALS AND METHODS


This was a prospective single-blinded (clinician only) randomized controlled trial. Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture. They received povidone-iodine, mupirocin, or saline sinus irrigations, twice daily for 30 days. Outcomes were post-treatment culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary).
RESULTS


Of the 62 subjects analyzed, post-treatment culture negativity rate was higher in the MUP (14/20, 70%) group compared to the PI (9/21, 43%) and SAL (9/19, 47%) groups, although this was not significant (p = 0.29). Povidone-iodine sinus irrigations at the 1% concentration were very well-tolerated, similar to saline irrigations. There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3 [-0.7, 0.05] vs. saline -0.4 [-0.8, 0.05]; p = 0.86) or Lund-Kennedy endoscopic score (povidone-iodine -3.5 [-7, -0.5] vs. mupirocin -2 [-4, 2] vs. saline -3 [-5, 0]; p = 0.45) change. No serious adverse effects were reported.
CONCLUSIONS


In patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations achieved a better post-treatment culture ""control"" rate compared to saline and povidone-iodine. In addition, 1% povidone-iodine solution was well-tolerated as a sinus irrigation and may represent a feasible method for temporarily disinfecting the sinonasal cavity of bacteria and viruses such as COVID-19.",2020,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","['patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations', 'sinusitis exacerbations in post-surgery subjects', 'chronic rhinosinusitis', '62 subjects analyzed', 'Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture']","['povidone-iodine, mupirocin, or saline sinus irrigations', 'Povidone-iodine sinus irrigations', 'saline -3', 'povidone-iodine solution', 'saline and povidone-iodine', 'Povidone-iodine', 'povidone-iodine or mupirocin versus saline sinus irrigations', 'topical anti-infectives']","['Lund-Kennedy endoscopic score', 'Tolerability and effectiveness', 'Sinonasal Outcome Test-20 score', 'culture negativity rate', 'culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018154', 'cui_str': 'Gram-positive bacteria'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5197691', 'cui_str': 'SNOT-20'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.208361,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America. Electronic address: vlee39@uic.edu.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pottinger', 'Affiliation': 'Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, 1959 NE Pacific St, PO Box 356130, Courier BB-302, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Davis', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102604']
1182,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE


This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English.
METHOD


Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation.
RESULTS


As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures.
CONCLUSIONS


Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004']
1183,32572652,Ticagrelor Versus Clopidogrel in Patients with Late or Very Late Stent Thrombosis.,"PURPOSE


To compare the effect of ticagrelor with clopidogrel in reducing the risk of ischemic cardiovascular events in patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI).
METHODS


A total of 4538 patients with acute coronary syndrome were screened for angiographically determined LST/VLST. Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n = 81) or clopidogrel (n = 160) at discharge. The clinical outcome was major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period.
RESULTS


After propensity score matching, 65 pairs were generated. The incidence of MACE was significantly lower in the ticagrelor group compared with the clopidogrel group (9.3% vs. 21.5%, log-rank p = 0.048). However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
CONCLUSION


Following successful primary PCI, patients with LST/VLST who received ticagrelor had fewer ischemic cardiovascular events at 1-yr follow-up, compared with those who received clopidogrel.",2020,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
","['patients with late or very late stent thrombosis (LST/VLST) after primary percutaneous coronary intervention (PCI', 'n\u2009=\u2009160) at discharge', 'Patients with Late or Very Late Stent Thrombosis', 'Two hundred and forty-one patients were included in the analysis and grouped according to ticagrelor (n\u2009=\u200981) or', '4538 patients with acute coronary syndrome']","['ticagrelor with clopidogrel', 'Ticagrelor Versus Clopidogrel', 'clopidogrel', 'ticagrelor']","['incidence of MACE', 'event rates of death, MI, ischemic stroke, and revascularization', 'ischemic cardiovascular events', 'major adverse cardiovascular events (MACE) defined as death, myocardial infarction (MI), ischemic stroke, and revascularization during the 1-yr follow-up period']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",4538.0,0.0802211,"However, no difference was observed in event rates of death, MI, ischemic stroke, and revascularization between the ticagrelor group and the clopidogrel group.
","[{'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhaoxue', 'Initials': 'Z', 'LastName': 'Sheng', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiannan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Runzhen', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Coronary Heart Disease Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. hbyanfuwai2018@163.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07021-w']
1184,32569395,Fast effectiveness of a solubilized low-dose budesonide nasal spray in allergic rhinitis.,"BACKGROUND


Budesonide, a poorly water-soluble corticosteroid, is currently marketed as a suspension. Budesolv is a novel aqueous formulation containing dissolved budesonide showing increased local availability in preclinical models. Budesolv contains ~85% less corticosteroid than the marketed comparator.
OBJECTIVE


The study (EudraCT:2018-001324-19) was designed to assess non-inferiority of Budesolv compared to Rhinocort® Aqua 64 (RA) and early onset of action.
METHODS


In a three-way cross-over double-blinded randomized trial, Budesolv 10 was compared to RA and placebo in grass pollen allergic rhinoconjunctivitis volunteers (n = 83 (ITT); n = 75 (PP)). On day 1, participants entered the Vienna Challenge Chamber (VCC) for 6 hours; first treatment took place at 1:45 hours after entry. Participants treated themselves for further 6 days; on day 8, the last treatment was applied before entering the VCC. Subjective symptom scores, nasal airflow and nasal secretion were measured regularly during allergen challenge.
RESULTS


Budesolv 10 was equally effective compared to RA with respect to TNSS and nasal airflow after eight days of treatment with a strongly reduced dose (more than 80% reduction). After first dose, only Budesolv 10 showed a significant reduction of nasal and respiratory symptoms starting 90 minutes (P < .05) and 15 minutes (P < .05) after application onwards, respectively, demonstrating an early onset of efficacy. A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (P < .05) after application.
CONCLUSIONS AND CLINICAL RELEVANCE


The novel preservative-free, aqueous low-dose budesonide formulation is highly efficacious even after an initial single treatment. Thus, Budesolv 10 appears to be an effective acute treatment for allergic rhinitis as well as for AR comorbidities like mild asthma and conjunctivitis.",2020,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","['allergic rhinitis', 'grass pollen allergic rhinoconjunctivitis volunteers (n=83 (ITT); n=75 (PP']","['Budesonide', 'RA and placebo', 'solubilized low-dose budesonide nasal spray']","['TNSS and nasal airflow', 'Subjective symptom scores, nasal airflow and nasal secretion', 'nasal symptom score', 'nasal and respiratory symptoms']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}]",,0.0434773,"A clinically significant 1 point reduction in nasal symptom score was reached at 195 minutes (p<0.05) after application.
","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmutz', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lemell', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Unger-Manhart', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Nakowitsch', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Goessl', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Savli', 'Affiliation': 'Biostatistik & Consulting, Hartberg, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Zieglmayer', 'Affiliation': 'Power Project GmbH, Vienna Challenge Chamber, Vienna, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Prieschl-Grassauer', 'Affiliation': 'Marinomed Biotech AG, Vienna, Austria.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13691']
1185,32442118,"Effects of Kinesio Taping on pain, paresthesia, functional status, and overall health status in patients with symptomatic thoracic outlet syndrome: A single-blind, randomized, placebo-controlled study.","OBJECTIVE


This study aimed to assess the effects of kinesio taping (KT) on pain, paresthesia, functional status, and overall health status in patients with symptomatic thoracic outlet syndrome (sTOS).
METHODS


A single-blind placebo-controlled design was employed in this study. The study duration was defined as 12 months. Analyses were performed on 60 patients with sTOS randomly assigned to KT (4 men and 26 women; mean age=33.5 years, range=20-46 years) and control groups (5 men and 25 women; mean age=26 years, range=20-43 years). KT was applied to the KT group three times. The control group received placebo taping. Pain and paresthesia were evaluated using the visual analogue scale (VAS) pain (10 cm) and VAS paresthesia (10 cm). The upper limb function was assessed using the disabilities of the arm, shoulder, and hand (DASH) questionnaire. The overall health status was evaluated based on the Nottingham Health Profile (NHP). Each assessment was carried out at baseline (t0), posttreatment (t1), and 8 weeks after baseline (t2).
RESULTS


In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1. At the second follow-up visit (t2), improvements remained visible compared with baseline. However, none of the variables improved from t1 to t2. Otherwise, all measures deteriorated slightly, and the deteriorations in VAS for pain, NHP pain, NHP sleep, and NHP physical abilities were statistically significant (p=0.041, p=0.048, p=0.013, and p=0.016, respectively). In the control group, only VAS for paresthesia and NHP emotional reaction showed improvement over time (p=0.002 and p=0.044, respectively). When changes in outcome measures between the two groups were compared, except NHP emotional reaction and NHP social isolation, median changes (from t0 to t1) were higher in the KT group than in the control group (p<0.05 for all variables). Regarding VAS pain, VAS paresthesia, DASH, and three NHP domains (energy level, pain, and physical abilities), changes from t0 to t2 were also higher in the KT group (p<0.05 for all variables).
CONCLUSION


KT can provide benefits in terms of relieving pain and paresthesia, as well as improving the upper limb function and quality of life in patients with sTOS.
LEVEL OF EVIDENCE


Level II, Therapeutic study.",2020,"In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1.","['patients with symptomatic thoracic outlet syndrome', '60 patients with sTOS randomly assigned to KT (4 men and 26 women; mean age=33.5 years, range=20-46 years) and control groups (5 men and 25 women; mean age=26 years, range=20-43 years', 'patients with sTOS', 'patients with symptomatic thoracic outlet syndrome (sTOS']","['placebo', 'kinesio taping (KT', 'placebo taping', 'kinesio taping']","['deteriorations in VAS for pain, NHP pain, NHP sleep, and NHP physical abilities', 'disabilities of the arm, shoulder, and hand (DASH) questionnaire', 'upper limb function', 'VAS for paresthesia and NHP emotional reaction', 'Pain and paresthesia', 'overall health status', 'VAS pain, VAS paresthesia, DASH, and three NHP domains (energy level, pain, and physical abilities', 'except NHP emotional reaction and NHP social isolation, median changes', 'pain, paresthesia, functional status, and overall health status', 'visual analogue scale (VAS) pain (10 cm) and VAS paresthesia', 'upper limb function and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0325014,"In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1.","[{'ForeName': 'Emine Aygül', 'Initials': 'EA', 'LastName': 'Ortaç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}, {'ForeName': 'Tunay', 'Initials': 'T', 'LastName': 'Sarpel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}, {'ForeName': 'İlke Coşkun', 'Initials': 'İC', 'LastName': 'Benlidayı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19042']
1186,32453406,Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial.,"Importance


Medication overuse headache (MOH) is a disabling, globally prevalent disorder representing a well-known and debated clinical problem. Evidence for the most effective treatment strategy is needed.
Objective


To compare 3 treatment strategies for MOH.
Design, Setting, and Participants


This open-label, randomized clinical trial with 6 months of follow-up was conducted in the tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019. Of 483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding. Of these, 75 refused participation and 120 were included. Data were analyzed from July 3 to September 6, 2019.
Interventions


Random assignment (1:1:1 allocation) to 1 of the 3 outpatient treatments consisting of (1) withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal.
Main Outcomes and Measures


The primary outcome was change in headache days per month after 6 months. Predefined secondary outcomes were change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH.
Results


Of 120 patients, 102 (mean [SD] age, 43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up. Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20). No difference was found in reduction of migraine days per month, use of short-term medication, or headache intensity. In the withdrawal plus preventive group, 23 of 31 patients (74.2%) reverted to episodic headache, compared with 21 of 35 (60.0%) in the preventive group and 15 of 36 (41.7%) in the withdrawal group (P = .03). Moreover, 30 of 31 patients (96.8%) in the withdrawal plus preventive group were cured of MOH, compared with 26 of 35 (74.3%) in the preventive group and 32 of 36 (88.9%) in the withdrawal group (P = .03). These findings corresponded to a 30% (relative risk, 1.3; 95% CI, 1.1-1.6) increased chance of MOH cure in the withdrawal plus preventive group compared with the preventive group (P = .03).
Conclusion and Relevance


All 3 treatment strategies were effective, but based on these findings, withdrawal therapy combined with preventive medication from the start of withdrawal is recommended as treatment for MOH.
Trial Registration


ClinicalTrials.gov Identifier: NCT02993289.",2020,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","['120 patients, 102 (mean [SD] age', '43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up', 'Medication Overuse Headache', 'tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019', '483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding', '75 refused participation and 120 were included']","['withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal']","['chance of MOH cure', 'reduction of migraine days per month, use of short-term medication, or headache intensity', 'Headache days per month', 'change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH', 'episodic headache', 'change in headache days', 'cured of MOH']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0039567', 'cui_str': 'Tertiary Sector'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",483.0,0.1209,"Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20).","[{'ForeName': 'Louise Ninett', 'Initials': 'LN', 'LastName': 'Carlsen', 'Affiliation': 'Currently a PhD student at the University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Signe Bruun', 'Initials': 'SB', 'LastName': 'Munksgaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Nielsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Ida Maria Storm', 'Initials': 'IMS', 'LastName': 'Engelstoft', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Maria Lurenda', 'Initials': 'ML', 'LastName': 'Westergaard', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bendtsen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Rigmor Højland', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Rigshospitalet, Glostrup, Denmark.'}]",JAMA neurology,['10.1001/jamaneurol.2020.1179']
1187,32453876,"Metabolomics Reveals Altered Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids Associated with Marginal Vitamin A Deficiency in a Mongolian Gerbil Model.","SCOPE


This study is designed to provide a broad evaluation of the impacts of vitamin A (VA) deficiency on hepatic metabolism in a gerbil model.
METHODS AND RESULTS


After 28 days of VA depletion, male Mongolian gerbils (Meriones unguiculatus) are randomly assigned to experimental diets for 28 days. Groups are fed a white-maize-based diet with ≈50 µL cottonseed oil vehicle either alone (VA-, n = 10) or containing 40 µg retinyl acetate (VA+, n = 10) for 28 days. Liver retinol is measured by high-performance liquid chromatography. Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides, and endocannabinoids are analyzed in post-mortem liver samples by liquid chromatography-mass spectrometry.
RESULTS


Liver retinol is lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency. A total of 300 metabolites are identified. Marginal VA deficiency is associated with lower bile acids, trimethylamine N-oxide, and a variety of acylcarnitines, phospholipids and sphingomyelins (p < 0.05). Components of DNA, including deoxyguanosine, cytidine, and N-carbomoyl-beta-alanine (p < 0.05), are differentially altered.
CONCLUSIONS


Hepatic metabolomics in a marginally VA-deficient gerbil model revealed alterations in markers of the gut microbiome, fatty acid and nucleotide metabolism, and cellular structure and signaling.",2020,"RESULTS


Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.",['male Mongolian gerbils (Meriones unguiculatus'],"['white maize-based diet with ∼50\xa0μL cottonseed oil vehicle either alone (VA-, n\xa0=\xa010) or containing 40\xa0μg retinyl acetate (VA+, n\xa0=\xa010) for 28 d. Liver retinol was measured by high-performance liquid chromatography (HPLC', 'vitamin A (VA) deficiency']","['Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides and endocannabinoids', 'Liver retinol', 'Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0324939', 'cui_str': 'Meriones unguiculatus'}, {'cui': 'C0022392', 'cui_str': 'Meriones'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073109', 'cui_str': 'Retinol acetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025249', 'cui_str': 'Membrane lipid'}]",300.0,0.057129,"RESULTS


Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'La Frano', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Brito', 'Affiliation': 'Laboratory of Pharmacokinetics and Metabolomic Analysis, Institute of Translational Medicine and Biotechnology, I. M. Sechenov First Moscow State Medical University, Moscow, 119991, Russia.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Baylee', 'Initials': 'B', 'LastName': 'Wilhelmson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Gannon', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'Rob K', 'Initials': 'RK', 'LastName': 'Fanter', 'Affiliation': 'College of Agriculture, Food and Environmental Sciences, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Pedersen', 'Affiliation': 'Department of Food Science and Technology, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'West Coast Metabolomics Center, University of California, Davis, CA, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901319']
1188,32557688,The contemplated average success probability for normally distributed models with an application to optimal sample sizes selection.,"We analytically obtain the average success probability (ASP) and the contemplated average success probability (CASP) for normally distributed observed differences in the treatment group and the placebo group means of the early trial and the confirmatory trial, assuming a uniform noninformative prior for the population treatment effect and a common known variance of the observations from both groups. For the CASP optimization problem with a fixed subtotal sample size of the early trial and the confirmatory trial of one arm larger than a threshold, we obtain the optimal plan of the sample sizes in a theorem. Moreover, in the theorem, we obtain the analytical formula of the optimal CASP as an increasing function of the subtotal sample size. After that, we calculate and compare the numerical values of the ASP with those in Table 1 of Chuang-Stein (2006). Finally, we investigate the numerical features of the CASP and find the optimal plan of the sample sizes for a given subtotal sample size.",2020,"We analytically obtain the average success probability (ASP) and the contemplated average success probability (CASP) for normally distributed observed differences in the treatment group and the placebo group means of the early trial and the confirmatory trial, assuming a uniform noninformative prior for the population treatment effect and a common known variance of the observations from both groups.",[],['placebo'],['average success probability (ASP'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0755397,"We analytically obtain the average success probability (ASP) and the contemplated average success probability (CASP) for normally distributed observed differences in the treatment group and the placebo group means of the early trial and the confirmatory trial, assuming a uniform noninformative prior for the population treatment effect and a common known variance of the observations from both groups.","[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics and Actuarial Science, College of Mathematics and Statistics, Chongqing University, Chongqing, China.'}, {'ForeName': 'Teng-Zhong', 'Initials': 'TZ', 'LastName': 'Rong', 'Affiliation': 'Department of Statistics and Actuarial Science, College of Mathematics and Statistics, Chongqing University, Chongqing, China.'}, {'ForeName': 'Man-Man', 'Initials': 'MM', 'LastName': 'Li', 'Affiliation': 'Department of Statistics and Actuarial Science, College of Mathematics and Statistics, Chongqing University, Chongqing, China.'}]",Statistics in medicine,['10.1002/sim.8658']
1189,32553717,Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate.,"OBJECTIVES


The aim was to fully characterize the plasma and urine washout pharmacokinetics of tenofovir (TFV) in adults following 6 weeks of controlled levels of tenofovir disoproxil fumarate (TDF) adherence, in order to inform the utility of clinic-based adherence testing.
DESIGN


This was a three-arm, randomized, open-label study in adult volunteers. Participants were randomized to receive TDF 300 mg/emtricitabine (FTC) 200 mg as (1) 7 doses/week (perfect adherence), (2) 4 doses/week (moderate adherence), or (3) 2 doses/week (low adherence). Plasma and urine samples were collected regularly during the 6-week dosing phase and for 4 weeks following drug cessation.
RESULTS


Twenty-eight adults were included in this analysis. Median (range) age was 33 (20-49) years. No differences in TFV pharmacokinetic parameters during the washout were observed across the study arms. Small differences in TFV plasma concentrations occurred across arms between 4 and 10 h post-dose. The cumulative amount of TFV excreted in urine was not different at 24 h post-dose, but at 148 h it was 24.8 mg, 21.0 mg, and 17.2 mg for the perfect, moderate, and low adherence arms, respectively (p = 0.043).
CONCLUSIONS


Among adults with different TDF adherence patterns, relative differences in plasma concentrations and cumulative urine extraction of TFV were minor following cessation. TFV measurement in plasma or urine is more indicative of last drug ingestion, rather than prior dose patterns.",2020,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","['Adults with Controlled Levels of Adherence to', 'adult volunteers', 'adults with different TDF adherence patterns', 'Median (range) age was 33 (20-49) years', 'Twenty-eight adults']","['Tenofovir Disoproxil Fumarate', 'TDF 300\u2009mg/emtricitabine (FTC']","['Plasma and urine samples', 'cumulative amount of TFV excreted in urine', 'TFV PK parameters', 'Plasma Pharmacokinetics and Urinary Excretion of Tenofovir', 'plasma concentrations and cumulative urine extraction of TFV', 'TFV measurement in plasma or urine', 'TFV plasma concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",28.0,0.0747984,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043).
","[{'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand; Department of Immunology and Infectious Diseases, Boston, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK. Electronic address: tim.cressey@phpt.org.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, CA, USA.'}, {'ForeName': 'Yardpiroon', 'Initials': 'Y', 'LastName': 'Tawon', 'Affiliation': 'PHPT/IRD UMI 174, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, CA, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.037']
1190,32683390,"Efficacy of a topical gel containing chitosan, chlorhexidine, allantoin and dexpanthenol for pain and inflammation control after third molar surgery: A randomized and placebo-controlled clinical trial.","BACKGROUND


The aim of this study was to evaluate and compare the postoperative effect of a topic gel containing chlorhexidine, chitosan, allantoine and dexpanthenol versus a placebo for pain and inflammation control after third molar surgery.
MATERIAL AND METHODS


A gel combining 0.2% chlorhexdine, 0.5% chitosan, 5% dexpanthenol, 0.15% allantoin and 0.01% sodium saccharin was selected for this split mouth randomized controlled and double-blind trial including 36 patients with bilaterally and symmetrically impacted lower third molars. The teeth (n=72) were randomly divided into two groups before surgical removal: control group (CG; in which a placebo was given) and experimental group (EG). Swelling, trismus, postoperative pain, wound healing and complications were measured and recorded in order to evaluate differences between the placebo and experimental product.
RESULTS


Five patients suffered from an alveolitis in the CG (13.9%), and none in the study group (0%), but no statistically significant difference was found (p=0.063). From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001). Mean VAS scores during the seven postoperative days were statistically lower in the study (2.56±1,19) compared to the placebo group (3.25±1.6) (p=0.002). The mean consumption of analgesic pills during the first 92 hours was also statistically lower in the EG (0.26±0.51) in comparison to the CG (0.56±0.67) (p=0.003).
CONCLUSIONS


The use of an experimental gel containing chlorhexidine, chitosan, allantoine and dexpanthenol seems to significantly reduce postoperative pain, trismus and signs of inflammation. Future studies should further evaluate, if the gel is effective in dry socket preventing after third molar removal.",2020,"From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001).","['36 patients with bilaterally and symmetrically impacted lower third molars', 'pain and inflammation control after third molar surgery', 'The teeth (n=72']","['topical gel containing chitosan, chlorhexidine, allantoin and dexpanthenol', 'placebo', 'surgical removal: control group (CG; in which a placebo', 'gel combining 0.2% chlorhexdine, 0.5% chitosan, 5% dexpanthenol, 0.15% allantoin and 0.01% sodium saccharin', 'chlorhexidine, chitosan, allantoine and dexpanthenol']","['trismus and swelling', 'mean consumption of analgesic pills', 'wound healing', 'Mean VAS scores', 'Swelling, trismus, postoperative pain, wound healing and complications', 'postoperative pain, trismus and signs of inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C1160728', 'cui_str': 'Cutaneous gel'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0057610', 'cui_str': 'dexpanthenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0917900', 'cui_str': 'Saccharin sodium'}]","[{'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",36.0,0.206127,"From day 0 to day 7, trismus and swelling were significantly less pronounced in the EG, and wound healing was considered 'good' in 22.2% for the CG and 97.2% for the EG (p<0.001).","[{'ForeName': 'L-M', 'Initials': 'LM', 'LastName': 'Sáez-Alcaide', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Molinero-Mourelle', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Serrano', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rubio-Alonso', 'Affiliation': ''}, {'ForeName': 'M-M', 'Initials': 'MM', 'LastName': 'Bornstein', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'López-Quiles', 'Affiliation': ''}]","Medicina oral, patologia oral y cirugia bucal",['10.4317/medoral.23661']
1191,32560485,Real-World Setting Cost-Effectiveness Analysis Comparing Three Therapeutic Schemes of One-Year Adjuvant Trastuzumab in HER2-Positive Early Breast Cancer from the Cyprus NHS Payer Perspective.,"INTRODUCTION


This study is one of the first real-world cost-effectiveness analyses of one-year adjuvant trastuzumab used in HER2-positive early female breast cancer in comparison to chemotherapy alone. It is just the second one in Europe, the first one in Cyprus, and the fourth one worldwide ever carried out using real-world data.
METHODS


Using a Markov model (four health states), a cost-effectiveness analysis was carried out both over 20 years and for a lifetime horizon. The sampling method used in this study was the randomized sampling of 900 women.
RESULTS


The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY]. For the lifetime horizon, with thresholds of €20,000, €40,000, and €60,000/QALY, all trastuzumab arms were found to be more cost-effective (ICER: €17,753.85/QALY). Moreover, for the 20-year and the lifetime horizons, with thresholds of €20,000/QALY, €40,000/QALY, and €60,000/QALY, the most cost-effective of the three subgroups (anthracyclines and then trastuzumab, no anthracyclines and then trastuzumab, and anthracyclines, taxanes, and trastuzumab) was that of anthracyclines and then trastuzumab (ICER: €18,301.55/QALY and €8954.97/QALY, respectively).
CONCLUSIONS


The study revealed that adjuvant trastuzumab for one year in female HER2-positive early breast cancer can be considered cost-effective.",2020,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","['HER2-positive early female breast cancer in comparison to chemotherapy alone', 'female HER2-positive early breast cancer', '900 women']","['Trastuzumab', 'adjuvant trastuzumab']","['quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY', 'cost-effective']","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0166592,"The findings for the 20-year horizon showed that all trastuzumab arms were more cost-effective, with a willingness-to-pay threshold of only €60,000 per quality-adjusted life year (QALY) [incremental cost-effectiveness ratios (ICER): €40,436.10/QALY].","[{'ForeName': 'Savvas S', 'Initials': 'SS', 'LastName': 'Ioannou', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}, {'ForeName': 'Yiola', 'Initials': 'Y', 'LastName': 'Marcou', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kakouri', 'Affiliation': 'Department of Medical Oncology, Bank of Cyprus Oncology Center, 32 Acropoleos Avenue, 2006 Strovolos, Nicosia 2255, Cyprus.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Talias', 'Affiliation': 'Healthcare Management Postgraduate Program, Open University Cyprus, P.O. Box 12794, Nicosia 2255, Cyprus.'}]",International journal of environmental research and public health,['10.3390/ijerph17124339']
1192,32561942,[A superoxide dismutase mimetic (GC4419) vs. placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer: a phase-IIb randomized double-blind study].,,2020,,['head and neck cancer'],"['superoxide dismutase mimetic (GC4419) vs. placebo', 'radiotherapy and cisplatin']",['severe oral mucositis'],"[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",,0.573769,,"[{'ForeName': 'Irenäus A', 'Initials': 'IA', 'LastName': 'Adamietz', 'Affiliation': 'Klinik für Strahlentherapie und Radio-Onkologie, Marien Hospital Herne Universitätsklinik, Ruhr-Universität Bochum, Hölkeskampring\xa040, 44625, Herne, Deutschland. irenaeus.adamietz@elisabethgruppe.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01639-3']
1193,32568220,Laparoscopic Radical Left Pancreatectomy for Pancreatic Cancer: Surgical Strategy and Technique Video.,"Radical resection margins, resection of Gerota's (perirenal) fascia, and adequate lymph node dissection are crucial for an adequate oncological resection of left-sided pancreatic cancer. Several surgical techniques have been described in recent years, but few were specifically designed for minimally invasive approaches. This study describes and demonstrates a standardized and reproducible technique for an adequate oncological resection of pancreatic cancer: laparoscopic radical left pancreatectomy (LRLP). A 61-year-old woman presented with an incidental finding of a 3 cm mass in the left pancreas suspect for malignancy. Imaging did not reveal distant metastases, central vascular involvement, or morbid obesity, hence the patient was suitable for LRLP. This study describes the main steps of LRLP for pancreatic cancer. First, the lesser sac is opened by transecting the gastrocolic ligament. The splenic flexure of the colon is mobilized and the inferior border of the pancreas including Gerota's fascia is dissected down to the inferior border of the spleen. The pancreas is tunneled and hung, including Gerota's fascia with a vessel loop. At the pancreatic neck, a tunnel is created between the pancreas and the portal vein, likewise a vessel loop is passed. The pancreas is then transected using the graded compression technique with an endostapler. Both the splenic vein and artery are transected before completing the resection. The entire specimen is extracted in a retrieval bag via a small Pfannenstiel incision. Duration of the surgery was 210 min with 250 mL blood loss. Pathology revealed a R0-resection (>1 mm) of a well-to-moderately differentiated adenocarcinoma originating from an intraductal papillary mucinous neoplasm. A total of 15 tumor-negative lymph nodes were resected. This is a detailed description of LRLP for left-sided pancreatic cancer as is currently being used within the international, multicenter randomized DIPLOMA (Distal Pancreatectomy Minimally Invasive or Open for PDAC) trial.",2020,"Imaging did not reveal distant metastases, central vascular involvement, or morbid obesity, hence the patient was suitable for LRLP.","['Pancreatic Cancer', 'A 61-year-old woman presented with an incidental finding of a 3 cm mass in the left pancreas suspect for malignancy', 'pancreatic cancer']","['laparoscopic radical left pancreatectomy (LRLP', 'LRLP', 'Laparoscopic Radical Left Pancreatectomy', 'Surgical Strategy and Technique Video', ""Radical resection margins, resection of Gerota's (perirenal) fascia, and adequate lymph node dissection""]",[],"[{'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0743997', 'cui_str': 'Incidental Findings'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0400476', 'cui_str': '50-70% distal pancreatectomy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0229985', 'cui_str': 'Surgical margins'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0227616', 'cui_str': 'Structure of fibrous capsule of kidney'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]",[],,0.0456372,"Imaging did not reveal distant metastases, central vascular involvement, or morbid obesity, hence the patient was suitable for LRLP.","[{'ForeName': 'Frederique L', 'Initials': 'FL', 'LastName': 'Vissers', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'Maurice J W', 'Initials': 'MJW', 'LastName': 'Zwart', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Balduzzi', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam; General and Pancreatic Surgery Department, Pancreas Institute, University and Hospital Trust of Verona.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Korrel', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Lof', 'Affiliation': 'Department of Surgery, Southampton University Hospital NHS Foundation Trust.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abu Hilal', 'Affiliation': 'Department of Surgery, Southampton University Hospital NHS Foundation Trust.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam; m.g.besselink@amsterdamumc.nl.'}]",Journal of visualized experiments : JoVE,['10.3791/60332']
1194,32572862,Outcomes of anterior versus posterior peroral endoscopic myotomy 2 years post-procedure: prospective follow-up results from a randomized clinical trial.,"BACKGROUND


Peroral endoscopic myotomy (POEM) is considered a primary treatment modality for achalasia. It can be performed using either the anterior or posterior approach. A previous randomized clinical trial (RCT) showed that the posterior approach was noninferior to the anterior approach at 1 year post-POEM in terms of clinical success, rate of adverse event, and risk of gastroesophageal reflux disease (GERD). The aim of this post-RCT study was to compare outcomes at ≥ 2 years post-POEM.
METHODS


Patients who previously completed the 1-year follow-up were contacted and their Eckardt, dysphagia, and GERD questionnaire (GERDQ) scores and frequency of proton pump inhibitor use were recorded. Clinical success was defined as an Eckardt score < 3.
RESULTS


150 patients were initially randomized and 138 completed the 1-year follow-up. Of the 138, 111 (anterior group 54, posterior group 57) also completed ≥ 2 years of follow-up, with an overall clinical success decrease from 89 % to 82 %. At ≥ 2 years post-POEM, clinical success was achieved in 46/54 (85 %) and 45/57 (79 %) in the anterior and posterior groups, respectively ( P  = 0.43). A similar decrease in clinical success was noted in both groups at ≥ 2 years (anterior: 90 % to 85 %; posterior 89 % to 79 %;  P  = 0.47). GERDQ score was 6 (interquartile range 6 - 8;  P  = 0.08) in both treatment groups.
CONCLUSIONS


The anterior and posterior POEM techniques remained equally effective at 2 years and decreases in efficacy were similar between the two approaches over time. GERD outcomes were also similar in both groups during medium-term follow-up.",2020,A similar decrease in clinical success was noted in both groups at ≥ 2-years,"['Patients who previously completed their 1-year follow-up were contacted and their', 'A total of 150 patients were initially randomized and 138 completed their 1-year follow-up']","['Peroal endoscopic myotomy (POEM', 'Anterior versus posterior peroral endoscopic myotomy']","['Clinical success', 'clinical success', 'clinical success, rate of adverse event and risk of gastroesophageal reflux disease (GERD', 'efficacy', 'GERDQ score', 'GERD outcomes', 'Eckardt (ES), Dysphagia, and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores and frequency of proton pump inhibitor (PPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0185181', 'cui_str': 'Incision of muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C4760898', 'cui_str': 'Peroral endoscopic myotomy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]",150.0,0.119721,A similar decrease in clinical success was noted in both groups at ≥ 2-years,"[{'ForeName': 'Yervant', 'Initials': 'Y', 'LastName': 'Ichkhanian', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Jad P', 'Initials': 'JP', 'LastName': 'Abimansour', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Pioche', 'Affiliation': 'Endoscopy and Gastroenterology Unit, Edouard Herriot Hospital, Lyon, France.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Vosoughi', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Eleftheriadis', 'Affiliation': 'Endoscopy Department, Gastroenterology Unit, Metropolitan Hospital Athens, Athens, Greece.'}, {'ForeName': 'Philip Wai Yan', 'Initials': 'PWY', 'LastName': 'Chiu', 'Affiliation': 'Division of Upper GI and Metabolic Surgery, Department of Surgery, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagazaki University Hospital, Nagazaki, Japan.'}, {'ForeName': 'Kumi', 'Initials': 'K', 'LastName': 'Ogihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagazaki University Hospital, Nagazaki, Japan.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Sanaei', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Manol', 'Initials': 'M', 'LastName': 'Jovani', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}, {'ForeName': 'Mouen A', 'Initials': 'MA', 'LastName': 'Khashab', 'Affiliation': 'Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institutions, Baltimore, Maryland, United States.'}]",Endoscopy,['10.1055/a-1204-4242']
1195,32570661,Preliminary Results from a Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Young Men.,Our study team developed the MyPEEPS Mobile App for improving HIV prevention behaviors in diverse young men. We conducted a randomized controlled trial and evaluated the preliminary outcomes in the first half (N=350) of our intended study sample. Higher self-efficacy for HIV prevention behaviors (p=0.0042) and more recent HIV tests in the past 3 months (p=0.0156) were reported by the intervention group compared to control. Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001). Preliminary results indicate that some sexual risk behaviors were reduced among the intervention group in the preliminary analytic sample.,2020,Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001).,"['diverse young men', 'Young Men']","['MyPEEPS Mobile', 'MyPEEPS Mobile App']","['HIV Prevention Behaviors', 'Numbers of condomless anal sex acts', 'receptive anal sex acts', 'sexual risk behaviors', 'HIV prevention behaviors']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0422696,Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001).,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University School of Nursing, NY, NY USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen Lorde Community Health Center, NY, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen Lorde Community Health Center, NY, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ganzhorn', 'Affiliation': 'Columbia University School of Nursing, NY, NY USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}]",Studies in health technology and informatics,['10.3233/SHTI200444']
1196,32570700,Acute Effects of a Whole Body Vibration Session on the Vibration Perception Threshold in Patients with Type 2 Diabetes Mellitus.,"BACKGROUND


Type 2 Diabetes Mellitus (T2DM) is a chronic disease that affects millions of people, and according to the International Diabetes Federation, 46.5% of people have undiagnosed diabetes. One of the most common complications of diabetes mellitus is loss of peripheral sensation. Whole Body Vibration (WBV) is a therapy, and it would be interesting to know if it can be considered as a training method to improve the Vibration Perception Threshold (VPT). The aim of the study is to verify whether there are really acute effects on the VPT after a WBV training session in people with T2DM.
METHODS


Ninety people with T2DM (56 men and 34 women) were randomly allocated to two groups: the WBV group and the placebo group. The ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device.
RESULTS


After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
CONCLUSIONS


Vibration perception threshold is increased after a WBV training session in people with T2DM, compared to a placebo group.",2020,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
","['ninety subjects went through a VPT training test before receiving the assigned intervention, and they performed the VPT test using the Vibratron II device', 'Patients with Type 2 Diabetes Mellitus', 'people with T2DM', 'Ninety people with T2DM (56 men and 34 women']","['Whole Body Vibration Session', 'placebo', 'Whole Body Vibration (WBV']","['VPT', 'Vibration Perception Threshold']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",90.0,0.0272834,"After one session of WBV, an increase of the VPT in the WBV group was found, with respect to the placebo group.
","[{'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Dominguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Hernandez-Mocholi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Villafaina', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Gordillo', 'Affiliation': 'Facultad de Administración y Negocios, Universidad Autónoma de Chile, sede Talca 3467987, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, 28943 Madrid, Spain.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Jose Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar', 'Affiliation': 'Health Economy Motricity and Education (HEME), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124356']
1197,32444573,"Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT).","PURPOSE


To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.
METHODS


Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure-88 (GMFM E) as the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5-week follow-up.
RESULTS


The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were -0.7 (-2.8 to 3.5) after RAGT and 0 (-2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow-up, or carry-over effects observable.
CONCLUSIONS


RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.",2020,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
","['children with cerebral palsy (PeLoGAIT', '16 children with a mean age of 11.3 years (6.0-15.3 years', 'ambulatory children with spastic cerebral palsy', 'Children']","['outpatient robot-assisted gait training (RAGT', 'robot-assisted gait training', 'RAGT']","['Dimension D (GMFM D), and timed walking tests', 'walking abilities', 'GMFM E median (IQR) change scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",16.0,0.0332735,"Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow - up, or carry - over effects observable.
","[{'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Ammann-Reiffer', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Caroline H G', 'Initials': 'CHG', 'LastName': 'Bastiaenen', 'Affiliation': 'Functioning and Rehabilitation, CAPHRI, Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Meyer-Heim', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}, {'ForeName': 'Hubertus J A', 'Initials': 'HJA', 'LastName': 'van Hedel', 'Affiliation': ""Swiss Children's Rehab, Research Department, University Children's Hospital Zurich, Eleonore Foundation, Affoltern am Albis, Switzerland.""}]",Journal of pediatric rehabilitation medicine,['10.3233/PRM-190614']
1198,32452208,"The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.","BACKGROUND


Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR.
HYPOTHESIS


Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at  P  < .10. The Cohen  d  was calculated to determine the effect size.
RESULTS


HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period ( P  < .05;  d  = 2.93). The primary outcome measure was knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque by 29% compared with the placebo group ( P  = .05;  d  = 0.80). Matrix metalloproteinase-3 (MMP3), which was used as an indirect biomarker of cartilage degradation, was 36% lower in the HGH group ( P  = .05;  d  = -1.34). HGH did not appear to be associated with changes in muscle volume or patient-reported outcome scores.
CONCLUSION


HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted.
REGISTRATION


NCT02420353 ( ClinicalTrials.gov identifier).",2020,Matrix metalloproteinase-3,"['patients undergoing ACLR', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction', 'Anterior cruciate ligament (ACL) tears are common knee injuries', '19 male patients (aged 18-35 years) scheduled to undergo ACLR', 'patients undergoing ACLR are warranted']","['extensive rehabilitation after ACL reconstruction (ACLR', 'Recombinant Human Growth Hormone', 'Placebo', 'Human growth hormone (HGH', 'Matrix metalloproteinase-3', 'placebo or HGH', 'HGH', 'placebo']","['quadriceps strength and reduced MMP3 levels', 'knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque', 'adverse events', 'Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers', 'circulating insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}]","[{'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",19.0,0.277985,Matrix metalloproteinase-3,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Mendias', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Elizabeth R Sibilsky', 'Initials': 'ERS', 'LastName': 'Enselman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Olszewski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Gumucio', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edon', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Konnaris', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Carpenter', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tariq M', 'Initials': 'TM', 'LastName': 'Awan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Jacobson', 'Affiliation': 'Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Joel J', 'Initials': 'JJ', 'LastName': 'Gagnier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Barkan', 'Affiliation': 'Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520920591']
1199,32462483,Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation-a randomized controlled trial.,"Preterm neonates with respiratory distress syndrome (RDS) are commonly treated with surfactant by intubate surfactant extubate (InSurE) technique. Mode of surfactant administration has evolved towards less invasive technique in the last few years. We randomised 58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive surfactant by InSurE or minimally invasive surfactant therapy (MIST). Non-invasive positive pressure ventilation (NIPPV) was used as primary respiratory support. The main objective was to compare the need of invasive mechanical ventilation (IMV) in first 72 h of life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality. We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32). No difference was observed in terms of hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality.Conclusion: There is no difference between MIST and InSurE in preterm neonates with RDS with NIPPV as a primary mode of respiratory support. Larger multicentre studies are needed to further explore differences in treatment failure and other secondary outcomes.Trial registration: www.ctri.nic.in id CTRI/2019/03/017992, registration date March 8, 2019. What is Known • InSurE is commonly used for many years for treatment of RDS in preterm neonates. • MIST has been introduced as a newer tool. What is New • MIST with feeding tube is comparable with InSurE in preterm infants with RDS in developing countries. •NIPPV can be used as primary respiratory support for MIST.",2020,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","['Preterm neonates with respiratory distress syndrome (RDS', 'preterm infants with RDS', 'preterm neonates with RDS with', '58 preterm infants of 28-34 weeks of gestation with RDS within 6 h of birth to receive', 'preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation']","['surfactant by intubate surfactant extubate (InSurE) technique', 'Minimally invasive surfactant therapy', 'invasive positive pressure ventilation (NIPPV', 'surfactant by InSurE or minimally invasive surfactant therapy (MIST', 'NIPPV']","['need of IMV', 'hs PDA, IVH (> grade 2), BPD and composite outcome of BPD/mortality', 'need of invasive mechanical ventilation (IMV', 'life and secondarily hemodynamically significant patent ductus arteriosus (hsPDA), intraventricular haemorrhage (IVH) (> grade 2), bronchopulmonary dysplasia (BPD) and composite outcome of BPD/mortality']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}]","[{'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",58.0,0.200468,"We did not find any difference in need of IMV in first 72 h between MIST and InSurE (relative risk with MIST, 0.62; 95% confidence interval, 0.22 to 1.32).","[{'ForeName': 'Bhupendra Kumar', 'Initials': 'BK', 'LastName': 'Gupta', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Anindya Kumar', 'Initials': 'AK', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Suchandra', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Saha', 'Affiliation': 'Department of Neonatology, Institute of Post Graduate Medical Education & Research and SSKM Hospital, 244, A J C Bose Road, Kolkata, 700020, India. bijansaha18@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03682-9']
1200,32554133,A video-game based cognitive training for breast cancer survivors with cognitive impairment: A prospective randomized pilot trial.,"INTRODUCTION


We investigated whether a web-based cognitive training video game is an effective approach to improve cognitive decline in combination with our standard of care for rehabilitation of breast cancer (BC) patients.
MATERIALS AND METHODS


Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied. The patients received access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™). The early intervention group (n = 23) had a training program of 6 months of at least three times a week for a minimum of 60 min of game playing per week at home in addition to standard of care rehabilitation. The delayed intervention (n = 23) received standard of care for three months, followed by three months of similar MyCQ training. Outcome measures were the MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests.
RESULTS


At baseline the means for CFQ (a measure of self-reported cognitive failure), anxiety, PSQI and self-reflectiveness were beyond normal range in both groups. CFQ improved significantly better in the intervention group (p = 0.029). Combining the evolution over time in the entire population a significant improvement was seen for overall MyCQ score, level of fear, physical and emotional role limitation, and health change (all p < 0.05), but self-reflectivess deteriorated (p < 0.05)). Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N back 1 and 2 (all p < 0.05).
CONCLUSION


A program of cognitive training improves cognitive functioning over time. ""Aquasnap"" has a beneficial effect on the perception of subjective cognitive functioning (CFQ) but the exact role of video gaming in this process remains uncertain.",2020,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","['Self-selected BC patients between 18 and 71 years old complaining of disturbing cognitive impairment were studied', 'breast cancer (BC) patients', 'breast cancer survivors with cognitive impairment']","['video-game based cognitive training', 'cognitive training', 'web-based cognitive training video game', 'MyCQ training', 'access to a web-based internet video game and online cognitive assessments (Aquasnap, Cambridge, MyCQ™']","['speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N', 'cognitive failure), anxiety, PSQI and self-reflectiveness', 'cognitive functioning', 'MyCQ (sub)scores and Activity of Daily Life (ADL), mood, subjective cognition and functional cognitive status measured by classic neuropsychological tests', 'overall MyCQ score, level of fear, physical and emotional role limitation, and health change', 'CFQ']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0411642,"Significant differences in the various MyCQ subtests over time were: improved speed in choice reaction time, visual memory recognition, N back 1 and 2, coding, trail making test B, improved accuracy of N","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellens', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Roelant', 'Affiliation': 'Clinical Trial Center (CTC), CRC Antwerp, Antwerp University Hospital, University of Antwerp, Edegem, B2650, Belgium; StatUa, Center for Statistics, University of Antwerp, Antwerp, B2000, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Sabbe', 'Affiliation': 'Department of Psychiatry, Antwerp University, Wilrijk, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'van Dam', 'Affiliation': 'Multidisciplinary Oncologic Center Antwerp (MOCA), Antwerp University Hospital, Edegem, B2650, Belgium; Centre for Oncological Research (CORE), University of Antwerp, Wilrijk, B2610, Belgium. Electronic address: peter.vandam@telenet.be.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.003']
1201,32561468,Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.,"Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.",2020,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","['Posttraumatic stress disorder (PTSD', 'PTSD among veterans with']","['Prolonged Exposure (PE) therapy', 'oxytocin', 'oxytocin (vs. placebo) administration combined with PE therapy', 'Intranasal oxytocin', 'placebo']","['PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.421747,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: jennifer.mitchell@ucsf.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: josh.woolley@ucsf.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Wangelin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bethany.wangelin@va.gov.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: john.mcquaid@va.gov.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: thomas.neylan@ucsf.edu.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: william.wolfe@ucsf.edu.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradykt@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106074']
1202,32565067,Smartphone-Based Therapeutic Exercises for Men Affected by Premature Ejaculation: A Pilot Study.,"INTRODUCTION


Smartphone-delivered healthcare interventions allow patients to access services on demand when needed, improving motivation and compliance. However, the use of mobile health apps has been scarcely explored in sexual medicine.
AIM


To evaluate the effects of integrating psychological treatment for premature ejaculation (PE) with a mobile coaching app that offers therapeutic exercises on the patient's smartphone.
METHODS


This study comprised 35 heterosexual men with primary psychogenic PE (mean age 34 years, standard deviation = 9.15). All patients entered a cycle of 15 sessions of psychodynamic psychotherapy integrating behavioral therapy, each lasting about 45 minutes. The patients were randomly assigned to 2 groups, each of which performed daily homework exercises (physiotherapy exercises for reinforcing the pelvic floor muscles and cognitive exercises for distancing from sexual failure.) The first group (15 patients) received verbal and printed instructions only (treatment as usual-TAU), whereas the second group (17 patients) experienced the exercises with guidance from the mobile app (app). In both groups, the exercises started after the seventh session. Patients were advised to perform the exercises 3 times a day for 3 months.
MAIN OUTCOME MEASURES


The primary outcome measures were the Premature Ejaculation Diagnostic Tool and the Premature Ejaculation Profile.
RESULTS


Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01). The frequency of patients with no-PE condition for the app group after treatment was significantly higher than the frequency of patients with no-PE condition for the TAU group (P < .001).
CONCLUSION


Results suggest that a mobile coaching app performs better than TAU in improving both the behavioral skills of ejaculatory delay and sexual self-confidence within a psychological treatment for PE. Future studies should collect follow-up data and explore the potential of mobile coaching apps in combined pharmacotherapy and psychotherapy interventions. Optale G, Burigat S, Chittaro L. et al. Smartphone-Based Therapeutic Exercises for Men Affected by Premature Ejaculation: A Pilot Study. J Sex Med 2020;8:461-471.",2020,"RESULTS


Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01).","['35 heterosexual men with primary psychogenic PE (mean age 34 years, standard deviation\xa0=\xa09.15', 'premature ejaculation (PE', 'Men Affected by Premature Ejaculation']","['integrating psychological treatment', 'Smartphone-Based Therapeutic Exercises', 'TAU', 'verbal and printed instructions only (treatment as usual-TAU', 'exercises with guidance from the mobile app (app', 'homework exercises (physiotherapy exercises for reinforcing the pelvic floor muscles and cognitive exercises for distancing from sexual failure', 'psychodynamic psychotherapy integrating behavioral therapy', 'Smartphone-delivered healthcare interventions']","['behavioral skills of ejaculatory delay and sexual self-confidence', 'Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores', 'frequency of patients with no-PE condition', 'Premature Ejaculation Diagnostic Tool and the Premature Ejaculation Profile']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0589414', 'cui_str': 'Homework'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1261382', 'cui_str': 'Psychodynamic psychotherapy'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",35.0,0.0387204,"RESULTS


Analysis of the data revealed significant pre-post improvements in Premature Ejaculation Diagnostic Tool and Premature Ejaculation Profile scores for the app group compared with those of the TAU group (P < .01).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Optale', 'Affiliation': 'Male and Female Sexual Dysfunctions Center of the Regione Veneto, ASL3, Mestre-Venezia, Italy. Electronic address: optale.gabriele@gmail.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Burigat', 'Affiliation': 'HCI Lab, Department of Mathematics, Computer Science, and Physics, Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Chittaro', 'Affiliation': 'HCI Lab, Department of Mathematics, Computer Science, and Physics, Università degli Studi di Udine, Udine, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Riva', 'Affiliation': 'Applied Technology for Neuro-Psychology Lab, IRCCS Istituto Auxologico Italiano, Milan, Italy; Department of Psychology, Università Cattolica del Sacro Cuore, Milan, Italy.'}]",Sexual medicine,['10.1016/j.esxm.2020.05.003']
1203,32574181,It's how you say it: Systematic A/B testing of digital messaging cut hospital no-show rates.,"Failure to attend hospital appointments has a detrimental impact on care quality. Documented efforts to address this challenge have only modestly decreased no-show rates. Behavioral economics theory has suggested that more effective messages may lead to increased responsiveness. In complex, real-world settings, it has proven difficult to predict the optimal message composition. In this study, we aimed to systematically compare the effects of several pre-appointment message formats on no-show rates. We randomly assigned members from Clalit Health Services (CHS), the largest payer-provider healthcare organization in Israel, who had scheduled outpatient clinic appointments in 14 CHS hospitals, to one of nine groups. Each individual received a pre-appointment SMS text reminder five days before the appointment, which differed by group. No-show and advanced cancellation rates were compared between the eight alternative messages, with the previously used generic message serving as the control. There were 161,587 CHS members who received pre-appointment reminder messages who were included in this study. Five message frames significantly differed from the control group. Members who received a reminder designed to evoke emotional guilt had a no-show rates of 14.2%, compared with 21.1% in the control group (odds ratio [OR]: 0.69, 95% confidence interval [CI]: 0.67, 0.76), and an advanced cancellation rate of 26.3% compared with 17.2% in the control group (OR: 1.2, 95% CI: 1.19, 1.21). Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format. Carefully selecting the narrative of pre-appointment SMS reminders can lead to a marked decrease in no-show rates. The process of a/b testing, selecting, and adopting optimal messages is a practical example of implementing the learning healthcare system paradigm, which could prevent up to one-third of the 352,000 annually unattended appointments in Israel.",2020,"Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format.","['161,587 CHS members who received pre-appointment reminder messages who were included in this study']","['Clalit Health Services (CHS), the largest payer-provider healthcare organization in Israel, who had scheduled outpatient clinic appointments']","['advanced cancellation rates', 'advanced cancellation rate']","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}]",,0.0627862,"Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format.","[{'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Berliner Senderey', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kornitzer', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Lawrence', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}, {'ForeName': 'Hilla', 'Initials': 'H', 'LastName': 'Zysman', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Hallak', 'Affiliation': 'Fuqua School of Business, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Balicer', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}]",PloS one,['10.1371/journal.pone.0234817']
1204,32445215,Comparative clinical study on microwave ablation combined with gemcitabine and cisplatin or combined with pemetrexed and cisplatin in treatment of advanced NSCLC.,"OBJECTIVE


Solving the limitations of single chemotherapy in the treatment of non-small cell lung cancer (NSCLC).
METHODS


About 100 patients with NSCLC treated in First Hospital of Jiaxing, Zhejiang from June 2016 to June 2018 were selected and randomly divided into MPC group and MGC group, with 50 cases in each group. The patients in MPC group were treated with microwave ablation (MWA) combined with PC while patients in MGC group were given MWA combined with gemcitabine plus cisplatin (GC). The therapeutic effects of the two groups as well as the complications and adverse reactions (ADRs) were observed and recorded.
RESULTS


There was no significant difference in disease response rate (MPC group 33.3% vs MGC group 32.0%), disease control rate (MPC group 86.4% vs MGC group 78.0%) and overall survival (1-, 2- and 3-year survival, MPC group 65%, 59%, 32.7% vs MGC group 58%, 46%, 30%) between the two groups. In addition, the ADR myelosuppression was slighter in MPC group. There were 12 cases (23%) developed myelosuppression in the MPC group and 20 cases (42%) in MGC group, with a significant difference between the two groups (P < 0.05). The treatment was interrupted for 0 case (0%) in MPC group because of myelosuppression while 4 cases (8.3%) in MGC group.
CONCLUSION


The two therapeutic regimens have similar efficacy in treatment of advanced NSCLC, but MPC causes slighter myelosuppression and can be the first-line therapy for advanced NSCLC.",2020,"There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (","['100 patients with NSCLC treated in First Hospital of Jiaxing, Zhejiang from June 2016 to June 2018', 'non-small cell lung cancer (NSCLC', 'advanced NSCLC']","['cisplatin plus gemcitabine or pemetrexed', 'single chemotherapy', 'MPC group and MGC', 'MWA combined with GC', 'MWA combined with PC']","['complications and ADRs', 'disease control rate', '1-, 2- and 3-year survival', 'overall survival', 'disease response rate', 'ADR myelosuppression', 'myelosuppression']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}]",100.0,0.0331002,"There was no significant difference in disease response rate (MPC group 33.3% vs. MGC group 32.0%), disease control rate (MPC group 86.4% vs. MGC group 78.0%) and overall survival (","[{'ForeName': 'YingQing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'YongLei', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'YingXin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}, {'ForeName': 'LinLan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation, The First Hospital of Jiaxing, Affiliated Hospital of Jiaxing University, Jiaxing, China.'}]",The clinical respiratory journal,['10.1111/crj.13219']
1205,32554035,Effect of a computer network-based feedback program on antibiotic prescription rates of primary care physicians: A cluster randomized crossover-controlled trial.,"OBJECTIVE


Antibiotic overuse is one of the major prescription problems in rural China and a major risk factor for antibiotic resistance. Low antibiotic prescription rates can effectively reduce the risk of antibiotic resistance. We hypothesized that under a paperless, computer-based feedback system the rates of antibiotic prescriptions among primary care physicians can be reduced.
METHODS


A cluster randomized crossover open controlled trial was conducted in 31 hospitals. These hospitals were randomly allocated to two groups to receive the intervention for three months followed by no intervention for three months in a random sequence. The feedback intervention information, which displayed the physicians' antibiotic prescription rates and ranking, was updated every 10 days. The primary outcome was the 10-day antibiotic prescription rate of the physicians.
RESULTS


There were 82 physicians in group 1 (intervention first followed by control) and 81 in group 2 (control first followed by intervention). Baseline comparison showed no significant difference in antibiotic prescription rate between the two groups (30.8% vs 35.2%, P-value=0.07). At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001). After a further 3 months, the rate of decline in antibiotic prescriptions was also significantly greater in the intervention group compared to the control group (14.2% vs 4.6%, P-value<0.001). The characteristics of physicians did not significantly determine the change in rate of antibiotic prescriptions.
CONCLUSION


A computer network-based feedback intervention can significantly reduce the antibiotic prescription rates of primary care outpatient physicians and continuously affected their prescription behavior for up to six months.
TRIAL REGISTRATION


ChiCTR1900021823.",2020,"At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001).","['31 hospitals', 'primary care physicians']","['computer network-based feedback intervention', 'computer network-based feedback program']","['rate of antibiotic prescriptions', 'antibiotic prescription rates', 'antibiotic prescription rate', 'risk of antibiotic resistance', '10-day antibiotic prescription rate of the physicians', 'rate of decline in antibiotic prescriptions']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]",,0.0905095,"At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value<0.001).","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'School of Medicine and Health Management, Guizhou Medical University, Guizhou 550025, China; Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Rassamee', 'Initials': 'R', 'LastName': 'Sangthong', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'McNeil', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'School of Medicine and Health Management, Guizhou Medical University, Guizhou 550025, China. Electronic address: tlei1974@163.com.'}, {'ForeName': 'Virasakdi', 'Initials': 'V', 'LastName': 'Chongsuvivatwong', 'Affiliation': 'Epidemiology Unit, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand. Electronic address: cvirasak@medicine.psu.ac.th.'}]",Journal of infection and public health,['10.1016/j.jiph.2020.05.027']
1206,31836178,"Perioperative tight glycemic control using artificial pancreas decreases infectious complications via suppression of inflammatory cytokines in patients who underwent pancreaticoduodenectomy: A prospective, non-randomized clinical trial.","BACKGROUND


We sought to investigate the efficacy of perioperative tight glycemic control (TGC) in reducing of postoperative infectious complications (POICs) and study its impact on early inflammatory mediators in patients who underwent pancreaticoduodenectomy.
METHODS


In this non-randomized trial, the artificial pancreas (AP) group received TGC (target glucose range of 80-110 mg/dL; n = 14), while the control group received conventional glycemic control (range of 80-180 mg/dL; n = 15). The primary endpoint was POICs.
RESULTS


The AP group had a markedly decreased POIC rate (28.6% vs. 73.3%; P = 0.027), mean glycemic variability (13.5 ± 3.5% vs. 16.4 ± 5.9%; P = 0.038), and plasma interleukin-6 level (26.3 ± 33.8 vs 98.3 ± 89.1 pg/ml; P = 0.036) compared to the control group, but insulin dosage (27.0 ± 13.4 vs. 10.2 ± 16.2 U; P = 0.002) and the adiponectin ratio (i.e., postoperative/preoperative adiponectin; 0.8 ± 0.2 vs. 0.6 ± 0.3; P = 0.021) were markedly higher in the AP group.
CONCLUSIONS


Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs.
SUMMARY


Perioperative hyperglycemia increases postoperative infectious complications; however, tight glycemic control using artificial pancreas can reduce them via a dual effect. Artificial pancreas facilitates strict and safe glycemic control while reducing anti-inflammatory mediators, including adiponectin, following pancreaticoduodenectomy.",2020,"Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs.
","['patients who underwent', 'patients who underwent pancreaticoduodenectomy', 'patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control']","['pancreaticoduodenectomy', 'artificial pancreas', 'artificial pancreas (AP) group received TGC', 'perioperative tight glycemic control (TGC', 'conventional glycemic control']","['mean glycemic variability', 'adiponectin ratio', 'POIC rate', 'plasma interleukin-6 level', 'POICs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0612314,"Among patients undergoing PD with impaired glucose tolerance, AP facilitated strict glycemic control and resulted in a reduction of anti-inflammatory mediators and POICs.
","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Akabori', 'Affiliation': 'Department of Surgery, Shiga, Japan. Electronic address: hakabori@belle.shiga-med.ac.jp.'}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Tani', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kitamura', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Maehira', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Imashuku', 'Affiliation': 'Department of Anesthesiology, Shiga, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tsujita', 'Affiliation': 'Department of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Surgery, Shiga, Japan.'}, {'ForeName': 'Hirotoshi', 'Initials': 'H', 'LastName': 'Kitagawa', 'Affiliation': 'Department of Anesthesiology, Shiga, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Critical and Intensive Care Medicine, Shiga University of Medical Science, Shiga, Japan.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.12.008']
1207,32570178,Effects of a 10-week multimodal dance and art intervention program leading to a public performance in persons with multiple sclerosis - A controlled pilot-trial.,"BACKGROUND


Dance therapy is increasingly reported in neurological diseases for improving several motor and cognitive functions, but was mostly studied in partner dance. No individual choreo-based dance program has ever been reported in MS.
OBJECTIVES


The aim of this pilot study is to investigate effects of a ten-week choreo-based dance intervention on different impairments in MS.
PARTICIPANTS


Seventeen participants with MS were allocated to a dance group (DG) or an art group (AG) for a ten-week intervention program, with a public live performance at the end of the intervention.
METHODS


The DG received choreo-based dance courses twice a week for 90 min, while the active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography. Measurements for fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place before and after the intervention. Differences were analysed with Wilcoxon Signed Rank test.
RESULTS


Both groups improved significantly on executive cognitive performance during dual task and fatigue. Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT). The AG showed significant improvements in on cognitive function (SDMT).
CONCLUSION


A ten-week multimodal dance intervention has positive effects on impact of fatigue, physical capacity and coordination, and cognitive performance during a dual task. Larger samples, follow-up measurements and research in different disability groups is recommended.",2020,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","['persons with multiple sclerosis', 'Seventeen participants with MS']","['active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography', 'ten-week choreo-based dance intervention', 'multimodal dance and art intervention program', 'dance group (DG) or an art group (AG']","['functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT', 'impact of fatigue, physical capacity and coordination, and cognitive performance', 'executive cognitive performance', 'fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place', 'cognitive function (SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",17.0,0.0172608,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Van Geel', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: fanny.vangeel@uhasselt.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Fit Up Neurological and Sport Physiotherapy, Antwerp, Belgium; Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Veldkamp', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: renee.veldkamp@uhasselt.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: peter.feys@uhasselt.be.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102256']
1208,32570237,Single-Center Noninferiority Randomized Trial on the Efficacy and Safety of Low- and High-Dose Rush Oral Milk Immunotherapy for Severe Milk Allergy.,"INTRODUCTION


Oral immunotherapy (OIT) has been reported to be effective but associated with a risk of severe symptoms. Thus, an OIT method with decreased risk is required.
OBJECTIVES


We aimed to evaluate the efficacy and safety of low- and high-dose OIT regimens in children with severe milk allergy.
METHODS


Overall, 33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included. The participants were randomly assigned to groups that received either a low (20 mL; n = 19) or high (100 mL; n = 14) maintenance target dose of OIT. The dose was gradually increased to the target dose in the rush escalation phase and was then maintained daily at home. The primary endpoint was the final OFC dose at 6 months of OIT. Adverse events during OIT were evaluated.
RESULTS


The final OFC dose after OIT was significantly higher than that before OIT in both groups (low-dose, p = 0.000; high-dose, p = 0.006), but there was no significant difference in the final OFC dose between the 2 groups (p = 0.767). In the maintenance phase, the high-dose group had significantly more severe symptoms than did the low-dose group (0.5%, 11/2,355 total intake events vs. 0.1%, 4/3,230 total intake events; p = 0.018).
CONCLUSIONS


An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy. The risk of severe symptoms in the maintenance phase was lower in the low-dose group. A low-dose OIT regimen is recommended for severe milk allergy.",2020,An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy.,"['Severe Milk Allergy', '33 participants (median age, 9 years; median final dose of the milk oral food challenge [OFC], 2 mL) were included', 'children with severe milk allergy']","['Low- and High-Dose Rush Oral Milk Immunotherapy', 'low- and high-dose OIT regimens']","['final OFC dose after OIT', 'Adverse events', 'severe symptoms', 'efficacy and safety', 'final OFC dose at 6 months of OIT', 'risk of severe symptoms', 'final OFC dose']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0079840', 'cui_str': 'Milk allergy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0443052', 'cui_str': 'Rush'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0436345', 'cui_str': 'Symptom severe'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0474029,An equally increased dose effect was observed for maintenance OIT doses of 20 and 100 mL in children with severe milk allergy.,"[{'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Takaoka', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan, zvb11075@nifty.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Yajima', 'Affiliation': 'Department of Pediatrics, Tannan Regional Medical Center, Sabae, Japan.'}, {'ForeName': 'Yoichi M', 'Initials': 'YM', 'LastName': 'Ito', 'Affiliation': 'Department of Biostatics, Hokkaido University Hospital Clinical Research and Medical Innovation Center, Sapporo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Kumon', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Muroya', 'Affiliation': 'Department of Pediatrics, Suita Municipal Hospital, Suita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Tsurinaga', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Amane', 'Initials': 'A', 'LastName': 'Shigekawa', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Pediatrics, Sumitomo Hospital, Osaka, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Iba', 'Affiliation': 'Department of Pediatrics, Arida Municipal Hospital, Arida, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Department of Pediatrics, Okinawa Chubu Hospital, Uruma, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Nishikido', 'Affiliation': ""Department of Respiratory and Allergy, Osaka Women's and Children's Hospital, Izumi, Japan.""}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Faculty of Education, Shitennoji University, Habikino, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kameda', 'Affiliation': 'Department of Pediatrics, Osaka Habikino Medical Center, Habikino, Japan.'}]",International archives of allergy and immunology,['10.1159/000508627']
1209,32578778,Comparison of the effect of ultrasound-guided thoracic paravertebral nerve block and intercostal nerve block for video-assisted thoracic surgery under spontaneous-ventilating anesthesia.,"OBJECTIVE


The aim of the current study was to compare the efficacy of two different techniques for blocking chest nerves during video-assisted thoracic surgery (VATS) under spontaneous-ventilating anesthesia.
METHODS


One hundred patients were recruited in this study and divided into two groups. The first, P group, underwent the TPVB approach; the second, I group, underwent the ICNB approach. Then, the rate of clinical efficacy, duration of the block procedure, and its complications were recorded for comparison of the effect of the two approaches.
RESULTS


No difference was found in the clinical effect of chest nerve blocks between the two groups. Two patients in the ICNB group were converted to general anesthesia due to severe mediastinal flutter (grade three). The number of patients who had grade one mediastinal flutter in the TPVB group was significantly higher than in the ICNB group. Vascular puncture was detected in four patients in the ICNB group and in one patient in the TPVB group. No other complications were observed.
CONCLUSIONS


No difference was found regarding the clinical efficacy in the two groups. However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia. Additionally, vascular puncture should receive more attention.",2020,"However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia.",['One hundred patients'],"['ICNB', 'ultrasound-guided thoracic paravertebral nerve block and intercostal nerve block for video-assisted thoracic surgery under spontaneous-ventilating anesthesia', 'video-assisted thoracic surgery (VATS']","['clinical effect of chest nerve blocks', 'clinical efficacy', 'rate of clinical efficacy, duration of the block procedure, and its complications', 'grade one mediastinal flutter', 'Vascular puncture', 'general anesthesia due to severe mediastinal flutter']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198806', 'cui_str': 'Paravertebral anesthesia'}, {'cui': 'C0196716', 'cui_str': 'Local anesthetic intercostal nerve block'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",100.0,0.0389686,"However, ultrasound-guided TPVB was superior to ultrasound-guided ICBN during VATS for pulmonary lobectomy under spontaneous-ventilating anesthesia.","[{'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Weibao', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Shao', 'Affiliation': "". Department of Anesthesiology, Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212002, China.""}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.4.452']
1210,32576219,"Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study).","BACKGROUND


Epidermolysis bullosa (EB) is a rare genetic disorder that manifests as blistering and/or skin erosion. There is no approved treatment for EB; current standard of care consists of wound and pain management. SD-101 6% is a topical cream containing 6% allantoin that was developed for treating skin lesions in patients with EB. The aim of this phase 3, multicenter, randomized, double-blind, vehicle-controlled study was to assess the efficacy and safety of SD-101 6% cream versus vehicle (0% allantoin) on lesions in patients with EB.
METHODS


Eligible patients were ≥1 month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50 cm 2  in size that was present for ≥21 days. Patients were randomly assigned to SD-101 6% cream or vehicle, which was applied topically once a day to the entire body for 3 months. Primary efficacy endpoints were time to complete target wound closure within 3 months and the proportion of patients who experienced complete target wound closure within 3 months. Post hoc subgroup analyses were conducted by patient age and in those with body surface area index of total body wound burden ≥5% at baseline.
RESULTS


In total, 169 patients were enrolled and randomly assigned to SD-101 6% (n = 82) or vehicle (n = 87). Baseline demographics and disease characteristics were similar between treatment groups. There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733 [0.365, 1.474]; nominal P = 0.390). A positive trend toward faster wound closure with SD-101 6% versus vehicle was observed in patients aged 2 to <12 years and those with total body wound burden ≥5% at baseline. SD-101 6% cream was well tolerated.
CONCLUSIONS


SD-101 6% cream for treatment of EB-associated lesions was not more effective than vehicle in shortening the time to complete target wound closure or achieving complete target wound closure within 3 months.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02384460; Date of trial registration, February 13, 2015; First participant enrolled, March 11, 2015.",2020,"There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733","['patients with EB.\nMETHODS\n\n\nEligible patients were\u2009≥1\u2009month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50\u2009cm 2  in size that was present for ≥21\u2009days', 'February 13, 2015; First participant enrolled, March 11, 2015', 'patients with epidermolysis bullosa', 'patients with EB', '169 patients']","['SD-101 6% cream versus vehicle (0% allantoin', 'SD-101 6% cream or vehicle', 'investigational topical cream SD-101 (6% allantoin']","['Baseline demographics and disease characteristics', 'Efficacy and tolerability', 'tolerated', 'skin lesions', 'efficacy and safety', 'time to target wound closure', 'time to complete target wound closure within 3\u2009months and the proportion of patients who experienced complete target wound closure', 'faster wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014527', 'cui_str': 'Epidermolysis bullosa'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",169.0,0.658526,"There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA. apaller@northwestern.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browning', 'Affiliation': 'Texas Dermatology & Laser Specialists, San Antonio, TX, USA.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Nikolic', 'Affiliation': 'Clinical Center of Serbia, Department of Dermatology, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bodemer', 'Affiliation': 'EB Reference Centre, Department of Dermatology, University Hospital Necker Enfants Malades, Paris, France.'}, {'ForeName': 'Dedee F', 'Initials': 'DF', 'LastName': 'Murrell', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Willistine', 'Initials': 'W', 'LastName': 'Lenon', 'Affiliation': 'Scioderm-An Amicus Therapeutics Company, Durham, NC, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krusinska', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Reha', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Hjalmar', 'Initials': 'H', 'LastName': 'Lagast', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Barth', 'Affiliation': 'Amicus Therapeutics, Inc, Cranbury, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01419-3']
1211,32584367,Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial.,"Importance


ERBB2 (HER2)-targeted therapy provides benefits in metastatic breast cancer (mBC) and gastric cancer, but additional treatments are needed to maximize efficacy and quality of life.
Objective


To determine maximum tolerated doses (MTDs) of trastuzumab emtansine (T-DM1) plus capecitabine in patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC) (phase 1) and the efficacy and safety of this combination vs T-DM1 alone in patients with mBC (phase 2).
Design, Setting, and Participants


The MTD in phase 1 was assessed using a 3 + 3 design with capecitabine dose modification. Phase 2 was an open-label, randomized, international multicenter study of patients with mBC treated with T-DM1 plus capecitabine or T-DM1 alone. Eligible patients had previously treated ERBB2-positive mBC or LA/mGC with no prior chemotherapy treatment for advanced disease.
Interventions


Patients in the phase 1 mBC cohort received capecitabine (750 mg/m2, 700 mg/m2, or 650 mg/m2 twice daily, days 1-14 of a 3-week cycle) plus T-DM1 3.6 mg/kg every 3 weeks. Patients with LA/mGC received capecitabine at the mBC phase 1 MTD, de-escalating as needed, plus T-DM1 2.4 mg/kg weekly. In phase 2, patients with mBC were randomized (1:1) to receive capecitabine (at the phase 1 MTD) plus T-DM1 or T-DM1 alone.
Main Outcomes and Measures


The phase 1 primary objective was to identify the MTD of capecitabine plus T-DM1. The phase 2 primary outcome was investigator-assessed overall response rate (ORR).
Results


In phase 1, the median (range) age was 54.0 (37-71) and 57.5 (53-70) years for patients with mBC and patients with LA/mGC, respectively. The capecitabine MTD was identified as 700 mg/m2 in 11 patients with mBC and 6 patients with LA/mGC evaluable for dose-limiting toxic effects. In phase 2, between October 2014 and April 2016, patients with mBC (median [range] age, 52.0 [28-80] years) were randomized to receive combination therapy (n = 81) or T-DM1 (n = 80). The ORR was 44% (36 of 81 patients) and 36% (29 of 80 patients) in the combination and T-DM1 groups, respectively (difference, 8.2%; 90% CI, -4.5 to 20.9; P = .34; clinical cutoff, May 31, 2017). Adverse events (AEs) were reported in 78 of 82 patients (95%) in the combination group, with 36 (44%) experiencing grade 3-4 AEs, and 69 of 78 patients (88%) in the T-DM1 group, with 32 (41%) experiencing grade 3-4 AEs. No grade 5 AEs were reported.
Conclusions and Relevance


Adding capecitabine to T-DM1 did not statistically increase ORR associated with T-DM1 in patients with previously treated ERBB2-positive mBC. The combination group reported more AEs, but with no unexpected toxic effects.
Trial Registration


ClinicalTrials.gov Identifier: NCT01702558.",2020,"No grade 5 AEs were reported.
","['patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC', 'patients with previously treated ERBB2-positive mBC', 'patients with mBC treated with', 'patients with mBC (phase 2', 'Eligible patients had previously treated ERBB2-positive mBC or LA/mGC with no prior chemotherapy treatment for advanced disease', 'HER2)-Positive Metastatic Breast Cancer', 'In phase 2, between October 2014 and April 2016, patients with mBC (median [range] age, 52.0 [28-80] years', 'metastatic breast cancer (mBC) and gastric cancer', 'Patients With Previously Treated ERBB2', 'patients with mBC']","['HER2)-targeted therapy', 'combination therapy', 'capecitabine (at the phase 1 MTD) plus T-DM1 or T-DM1 alone', 'T-DM1 plus capecitabine or T-DM1 alone', 'capecitabine MTD', 'capecitabine', 'trastuzumab emtansine (T-DM1) plus capecitabine', 'Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone']","['Efficacy and Safety', 'investigator-assessed overall response rate (ORR', 'Importance\n\n\nERBB2', 'ORR', 'efficacy and safety', 'Adverse events (AEs', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.170456,"No grade 5 AEs were reported.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'Quirónsalud Group, IOB Institute of Oncology, Madrid, Spain.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Hematology/Medical Oncology, 3rd Department of Internal Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montemurro', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Immunologie, Universitätsklinikum Gießen und Marburg, Standort Marburg, Philipps-Universität Marburg, Baldingerstraße, Marburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Allegrini', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Pontedera Hospital, Azienda L Toscana Nord Ovest, Pisa, Italy.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Division of Breast Medical Oncology, Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Napoli, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lohrisch', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Oravcová', 'Affiliation': '2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Perez-Garcia', 'Affiliation': 'Quirónsalud Group, IOB Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Sakaeva', 'Affiliation': 'Department of Chemotherapy, Republican Clinical Oncology Center, Ufa, Russia.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Serpanchy', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Šufliarský', 'Affiliation': '2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Irahara', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wohlfarth', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Aout', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1796']
1212,32584384,Association of Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density in Patients With Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Although previous studies have evaluated the association between anti-vascular endothelial growth factor therapy and macular vessel density, they were confounded by the presence of macular edema, which may be associated with artifacts and segmentation errors in optical coherence tomography angiography (OCTA).
Objective


To evaluate the association of intravitreal aflibercept with changes in macular vascular density using OCTA in patients with proliferative diabetic retinopathy without diabetic macular edema.
Design, Setting, and Participants


This post hoc analysis of a randomized clinical trial used data on 40 eyes of 40 patients with proliferative diabetic retinopathy without diabetic macular edema who were enrolled in the Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy (RECOVERY) clinical trial from August 1, 2016, to June 31, 2017. Three patients were lost to follow-up at month 12, and 5 patients were excluded from analysis because of poor OCTA image quality, leaving 16 patients in each cohort in the final analysis. Data analysis was performed from March 1, 2018, to January 15, 2019.
Intervention


In the RECOVERY trial, patients were randomized into cohorts receiving 2 mg of aflibercept injections monthly (n = 20) or quarterly (n = 20) and treated for 12 months.
Main Outcomes and Measures


The percentage of vascular density (in total scan and foveal and parafoveal regions) was compared before and after 12 months of therapy.
Results


The sample for this OCTA analysis included 32 eyes from 32 patients (mean [SD] age, 48.37 [12.30] years; 17 [53.1%] male). The mean (SD) total scan vascular density for the superficial vascular complex was 42.28% (4.03%; 95% CI, 40.63%-43.93%) at baseline and 39.64% (4.01%; 95% CI, 37.91%-41.37%) at month 12 (P = .69). For the deep vascular complex, the mean (SD) vascular density was 48.42% (4.99%; 95% CI, 46.36%-50.47%) at baseline and 45.69% (4.63%; 95% CI, 43.69%-47.70%) at month 12 (P = .40). For the choriocapillaris, the mean (SD) vascular density was 64.42% (3.36%; 95% CI, 63.04%-65.81%) at baseline and 62.55% (4.79%; 95% CI, 60.48%-64.62%) at month 12 (P = .16). There was no difference in vascular density parameters between monthly and quarterly injection arms at month 12.
Conclusions and Relevance


In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy. Because nonperfusion is expected to progress in diabetic retinopathy, this finding may represent a beneficial association between anti-vascular endothelial growth factor therapy and macular vascular density.
Trial Registration


ClinicalTrials.gov Identifier: NCT02863354.",2020,"In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy.","['32 eyes from 32 patients (mean [SD] age, 48.37', 'Patients With Proliferative Diabetic Retinopathy', '40 eyes of 40 patients with proliferative diabetic retinopathy without diabetic macular edema who were enrolled in the Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy (RECOVERY) clinical trial from August 1, 2016, to June 31, 2017', 'patients with proliferative diabetic retinopathy without diabetic macular edema', '12.30] years; 17 [53.1%] male']","['aflibercept injections', 'OCTA', 'Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density', 'intravitreal aflibercept']","['macular vascular density', 'mean (SD) total scan vascular density for the superficial vascular complex', 'percentage of vascular density (in total scan and foveal and parafoveal regions', 'mean (SD) vascular density', 'vascular density parameters']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4049512', 'cui_str': 'Retinal nonperfusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",3.0,0.299412,"In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy.","[{'ForeName': 'Ahmed Roshdy', 'Initials': 'AR', 'LastName': 'Alagorie', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Muneeswar Gupta', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Swetha', 'Initials': 'S', 'LastName': 'Velaga', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Rusakevich', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2130']
1213,32445184,Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program.,"INTRODUCTION


Etrolizumab is a next-generation anti-integrin with dual action that targets two pathways of inflammation in the gut. A robust phase 3 clinical program in ulcerative colitis (UC) and Crohn's disease is ongoing and will evaluate the efficacy and safety of etrolizumab in well-defined patient populations in rigorous trials that include direct head-to-head comparisons against approved anti-tumor necrosis factor alpha agents (anti-TNF). The etrolizumab phase 3 clinical program consists of six randomized controlled trials (RCTs; UC: HIBISCUS I and II, GARDENIA, LAUREL, HICKORY; Crohn's disease: BERGAMOT) and two open-label extension trials (OLEs; UC: COTTONWOOD; Crohn's disease: JUNIPER) evaluating patients with moderately to severely active UC or Crohn's disease.
METHODS


In the UC RCTs, patients are randomly assigned according to each protocol to receive etrolizumab, adalimumab, infliximab, or placebo. In BERGAMOT, patients are randomly assigned to receive etrolizumab 105 mg, etrolizumab 210 mg, or placebo. The primary outcomes for the UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease). The OLEs will primarily assess long-term efficacy and safety. Secondary and exploratory endpoints include endoscopy, histology, quality of life, and biomarkers at various timepoints.
DISCUSSION


The etrolizumab phase 3 clinical program is the largest and most comprehensive in inflammatory bowel disease, enrolling more than 3000 patients. The program explores both induction and maintenance regimens. HIBISCUS I and II and GARDENIA are among the first head-to-head trials in UC against an anti-TNF and are the first registrational trials making that comparison. This program will also help address unanswered clinical questions on evaluation of treatment effects and treatment selection across a range of patients with varying treatment histories using an extensive repository of patient samples and data.
TRIAL REGISTRATION


ClinicalTrials.gov: HIBISCUS I (NCT02163759), HIBISCUS II (NCT02171429), GARDENIA (NCT02136069), LAUREL (NCT02165215), HICKORY (NCT02100696), COTTONWOOD (NCT02118584), BERGAMOT (NCT02394028), JUNIPER (NCT02403323).",2020,HIBISCUS ,"['3000 patients', ""Ulcerative Colitis and Crohn's Disease"", ""patients with moderately to severely active UC or Crohn's disease""]","['Etrolizumab', 'etrolizumab, adalimumab, infliximab, or placebo', 'etrolizumab 105\xa0mg, etrolizumab 210\xa0mg, or placebo', 'etrolizumab']","[""UC RCTs are Mayo Clinic score-based clinical response, remission, and clinical remission; for BERGAMOT, the co-primary outcomes are clinical remission (based on abdominal pain and stool frequency) and endoscopic improvement (based on the Simple Endoscopic Score for Crohn's disease"", 'endoscopy, histology, quality of life, and biomarkers at various timepoints']","[{'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3177463', 'cui_str': 'rhuMAb Beta7'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3715207', 'cui_str': 'Bergamot orange extract'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.181287,HIBISCUS ,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Vermeire', 'Affiliation': 'University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tyrrell', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Azra', 'Initials': 'A', 'LastName': 'Hassanali', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lacey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Tole', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland.'}, {'ForeName': 'Amanda R', 'Initials': 'AR', 'LastName': 'Tatro', 'Affiliation': 'F. Hoffmann-La Roche AG, Global Product Development Medical Affairs, 4070, Basel, Switzerland. amanda.tatro@roche.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01366-2']
1214,32449022,Acetic acid disinfection as a potential adjunctive therapy for non-severe COVID-19.,"PURPOSE


SARS-CoV-2 is a new pandemic influenza caused by a coronavirus which main route of transmission is through exhaled droplets that primarily infect the nose and the nasopharynx. The aim of this paper is to evaluate the effect of acetic acid, the active component of vinegar, as a potential disinfectant agent for upper airways.
METHODS


Twenty-nine patients were enrolled and divided into two groups: group 1 (14 patients) was composed of patients treated with off-label hydroxychloroquine and lopinavir/ritonavir, whereas group 2 (15 patients) was composed of patients treated with hydroxychloroquine only, combined with the inhalation of acetic acid disinfectant at a 0.34% concentration. A questionnaire-based evaluation of symptoms was performed after 15 days in both groups.
RESULTS


It appears that the number of patients treated with acetic acid (group 2) that experienced improvement in individual symptoms was double that of the other group of patients (group 1), although numbers are too small for robust statistical analysis.
CONCLUSIONS


Considering its potential benefits and high availability, acetic acid disinfection appears to be a promising adjunctive therapy in cases of non-severe COVID-19 and deserves further investigation.",2020,"It appears that the number of patients treated with acetic acid (group 2) that experienced improvement in individual symptoms was double that of the other group of patients (group 1), although numbers are too small for robust statistical analysis.
",['Twenty-nine patients'],"['hydroxychloroquine only, combined with the inhalation of acetic acid disinfectant', 'acetic acid', 'Acetic acid disinfection', 'label hydroxychloroquine and lopinavir/ritonavir']",['individual symptoms'],"[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",29.0,0.0329194,"It appears that the number of patients treated with acetic acid (group 2) that experienced improvement in individual symptoms was double that of the other group of patients (group 1), although numbers are too small for robust statistical analysis.
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Pianta', 'Affiliation': 'Department of Otorhinolaryngology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vinciguerra', 'Affiliation': 'Division of Head and Neck Department, Otorhinolaryngology Unit, San Raffaele Hospital, IRCCS San Raffaele Scientific Institute, Via Olgettina, 68, 20100, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bertazzoni', 'Affiliation': 'Department of Otorhinolaryngology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'Department of Otorhinolaryngology, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mangiatordi', 'Affiliation': 'Department of Emergency, ASST Cremona, Cremona, Italy.'}, {'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Lund', 'Affiliation': 'Royal National Throat, Nose and Ear Hospital, UCLH, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Trimarchi', 'Affiliation': 'Division of Head and Neck Department, Otorhinolaryngology Unit, San Raffaele Hospital, IRCCS San Raffaele Scientific Institute, Via Olgettina, 68, 20100, Milan, Italy. trimarchi.matteo@hsr.it.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06067-8']
1215,32449896,Peritoneal Flap in Robot-Assisted Radical Prostatectomy.,"BACKGROUND


Lymphocele is the most common complication arising after pelvic lymph node dissection (PLND) in the setting of robot-assisted radical prostatectomy (RARP). The only data available until now on the utility of a peritoneal flap to prevent lymphocele were retrospectively acquired.
METHODS


A randomized, controlled, multi-center trial with blinded assessment of endpoints was carried out on 232 patients with prostate cancer who underwent RARP with PLND. The patients in the intervention group were given a peritoneal flap; in the control group, surgery was performed without this modification. The two joint primary endpoints were the rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2). The secondary endpoints were lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence. German Clinical Trials Register number: DRKS00011115.
RESULTS


The data were evaluated in an intention-to-treat analysis, which, in this trial, was identical to an as-treated analysis. 108 patients (46.6%) were allotted to the intervention group. There were no statistically significant intergroup differences with respect to any clinical or histopathological criteria. A median of 16 lymph nodes were removed (interquartile range, 11-21). A symptomatic lymphocele arose in 1.3% (iT1) and 9.1% (iT2) of the patients, without any statistically significant difference between the two trial groups (p = 0.599 and p = 0.820, respectively). Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2). 81.5% of all patients (n = 189) had no complications at all in the first three months after surgery. Nor were there any intergroup differences at 90 days with respect to the degree of stress urinary incontinence (p = 0.306) or complications (p = 0.486).
CONCLUSION


A peritoneal flap after RARP was not found to influence the rate of postoperative lymphocele, whether asymptomatic or requiring treatment.",2020,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","['232 patients with prostate cancer who underwent RARP with PLND', '108 patients (46.6']","['Peritoneal Flap in Robot-Assisted Radical Prostatectomy', 'peritoneal flap', 'robot-assisted radical prostatectomy (RARP']","['degree of stress urinary incontinence', 'rate of postoperative lymphocele', 'lymphocele volume, the need for treatment of lymphocele, complications requiring an intervention, and the degree of postoperative stress incontinence', 'rates of symptomatic lymphocele during the same hospitalization as the operative procedure (iT1) and within 90 days of surgery (iT2', 'lymphocele volume', 'symptomatic lymphocele', 'no complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C1998084', 'cui_str': 'Lymphocele after surgical procedure'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",232.0,0.0672329,"Nor did the groups differ significantly with respect to lymphocele volume (p = 0.670 on hospital discharge [T1], p = 0.650 90 days after surgery [T2]) or the type and frequency of need for subsequent surgical intervention (p = 0.535; iT2).","[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Bründl', 'Affiliation': 'Department of Urology, University of Regensburg, Caritas St. Josef Medical Center, Regensburg, Germany; Department of Urology and Andrology, Hospital of St. John of God (Krankenhaus der Barmherzigen Brüder Wien), Vienna, Austria; Department of Urology and Andrology, Paracelsus Medical University Salzburg, Salzburg, Austria; Department of Urology, St. Elisabeth Hospital Straubing, Straubing, Germany; Department of Urology, Vivantes Humboldt Hospital Berlin, Berlin Germany; These two authors are co-first authors.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lenart', 'Affiliation': ''}, {'ForeName': 'Gjoko', 'Initials': 'G', 'LastName': 'Stojanoski', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gilfrich', 'Affiliation': ''}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Rosenhammer', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stolzlechner', 'Affiliation': ''}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Ponholzer', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dreissig', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weikert', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'May', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0243']
1216,32459322,Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial.,"Importance


Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications.
Objective


To determine whether postoperative PCIA decreases the occurrence of gastrointestinal complications after pancreatic surgery compared with EDA.
Design, Setting, and Participants


In this adaptive, pragmatic, international, multicenter, superiority randomized clinical trial conducted from June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy were randomized to receive PCIA (n = 185) or EDA (n = 186); 248 patients (124 in each group) were analyzed. Data were analyzed from February 22 to April 25, 2019, using modified intention to treat and per protocol.
Interventions


Patients in the PCIA group received general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device. In the EDA group, patients received general anesthesia and intraoperative and postoperative EDA.
Main Outcomes and Measures


The primary end point was a composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus within 30 days after surgery. Secondary end points included 30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution.
Results


Among the 248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years), the primary composite end point did not differ between the PCIA group (61 [49.2%]) and EDA group (57 [46.0%]) (odds ratio, 1.17; 95% CI, 0.71-1.95 P = .54). Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups. Patients receiving EDA gained more weight by postoperative day 4 than patients receiving PCIA (mean [SD], 4.6 [3.8] vs 3.4 [3.6] kg; P = .03) and received more vasopressors (46 [37.1%] vs 31 [25.0%]; P = .04). Failure of EDA occurred in 23 patients (18.5%).
Conclusions and Relevance


This study found that the choice between PCIA and EDA for pain control after pancreatic surgery should not be based on concerns regarding gastrointestinal complications because the 2 procedures are comparable with regard to effectiveness and safety. However, EDA was associated with several shortcomings.
Trial Registration


German Clinical Trials Register: DRKS00007784.",2020,"Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups.","['June 30, 2015, to October 1, 2017, 371 patients at 9 European pancreatic surgery centers who were scheduled for elective pancreatoduodenectomy', '248 patients analyzed (147 men; mean [SD] age, 64.9 [10.7] years', 'pain control after pancreatic surgery', 'n\u2009=\u2009186); 248 patients (124 in each group) were analyzed']","['Pancreatoduodenectomy', 'Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA', 'EDA', 'Epidural vs Patient-Controlled Intravenous Analgesia', 'PCIA and EDA', 'general anesthesia and postoperative PCIA with intravenous opioids with the help of a patient-controlled analgesia device', 'PCIA']","['gastrointestinal complications', '30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids', '30-day mortality, other complications, postoperative pain levels, intraoperative or postoperative use of vasopressor therapy, and fluid substitution', 'composite of pancreatic fistula, bile leakage, delayed gastric emptying, gastrointestinal bleeding, or postoperative ileus', 'Gastrointestinal Complications', 'Failure of EDA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0400997', 'cui_str': 'Leakage of bile'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]",,0.168465,"Neither individual components of the primary end point nor 30-day mortality, postoperative pain levels, or intraoperative and postoperative substitution of fluids differed significantly between groups.","[{'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Klotz', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Larmann', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Klose', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Benner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Doerr-Harim', 'Affiliation': 'The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Tenckhoff', 'Affiliation': 'The Study Centre of the German Surgical Society, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Lock', 'Affiliation': 'Department of General, Visceral, Transplant, Vascular and Paediatric Surgery, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Elmar-Marc', 'Initials': 'EM', 'LastName': 'Brede', 'Affiliation': 'Department of Anaesthesiology and Critical Care, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Surgical and Oncological Department, Pancreas Institute, University Hospital Trust, Verona, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Polati', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Verona University Hospital, Verona, Italy.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Köninger', 'Affiliation': 'Department of General, Visceral, Thorax and Transplantation Surgery, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Jan-Henrik', 'Initials': 'JH', 'LastName': 'Schiff', 'Affiliation': 'Department of Anaesthesiology and Operative Intensive Care, Klinikum Stuttgart, Katharinenhospital, Stuttgart, Germany.'}, {'ForeName': 'Uwe A', 'Initials': 'UA', 'LastName': 'Wittel', 'Affiliation': 'Department of General and Visceral Surgery, Medical Centre, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hötzel', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Medical Centre, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Keck', 'Affiliation': 'Department of Surgery, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nau', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University Medical Centre Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Anca-Laura', 'Initials': 'AL', 'LastName': 'Amati', 'Affiliation': 'Department of Visceral, Thoracic, Transplant and Paediatric Surgery, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eberl', 'Affiliation': 'Department of Surgery, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zink', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, General Public Hospital of the Brothers of St John of God, St Veit/Glan, Austria.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Tomazic', 'Affiliation': 'Department of Abdominal Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Novak-Jankovic', 'Affiliation': 'Clinical Department of Anaesthesiology and Intensive Therapy, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hofer', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Weigand', 'Affiliation': 'Department of Anaesthesiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2020.0794']
1217,32462740,Vitamin D supplementation for sickle cell disease.,"BACKGROUND


Sickle cell disease (SCD) is a genetic chronic haemolytic and pro-inflammatory disorder. With increased catabolism and deficits in energy and nutrient intake, individuals with SCD suffer multiple macro- and micro-nutritional deficiencies, including vitamin D deficiency. This is an update of a previous review.
OBJECTIVES


To investigate the effects of vitamin D supplementation in children and adults with SCD and to compare different dose regimens. To determine the effects of vitamin D supplementation on general health (e.g. growth status and health-related quality of life), on musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections) and the safety of vitamin D supplementation.
SEARCH METHODS


We searched the Cochrane Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. Date of last search: 19 March 2020. We also searched database such as PubMed, clinical trial registries and the reference lists of relevant articles and reviews. Date of last search: 14 January 2020.
SELECTION CRITERIA


Randomised controlled trials (RCTs) and quasi-RCTs comparing oral administration of any form of vitamin D supplementation at any dose and for any duration to another type or dose of vitamin D or placebo or no supplementation in people with SCD, of all ages, gender, and phenotypes.
DATA COLLECTION AND ANALYSIS


Two authors independently extracted the data and assessed the risk of bias of the included studies. They used the GRADE guidelines to assess the quality of the evidence.
MAIN RESULTS


Vitamin D versus placebo One double-blind RCT (n = 39) compared oral vitamin D3 (cholecalciferol) supplementation (20 participants) to placebo (19 participants) for six weeks. Only 25 participants completed the full six months of follow-up. The study had a high risk of bias due to incomplete outcome data, but a low risk of bias for randomisation, allocation concealment, blinding (of participants, personnel and outcome assessors) and selective outcome reporting; and an unclear risk of other biases. Vitamin D supplementation probably led to higher serum 25(OH)D levels at eight weeks, mean difference (MD) 29.79 (95% confidence interval (CI) 26.63 to 32.95); at 16 weeks, MD 12.67 (95% CI 10.43 to 14.90); and at 24 weeks, MD 15.52 (95% CI 13.50 to 17.54) (moderate-quality evidence). There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence). Vitamin D supplementation probably caused fewer pain days compared to the placebo group at eight weeks, MD -10.00 (95% CI -16.47 to -3.53) (low-quality evidence), but probably led to a lower (worse) health-related quality of life score (change from baseline in physical functioning PedsQL scores); at both 16 weeks, MD -12.56 (95% CI -16.44 to -8.69) and 24 weeks, MD -12.59 (95% CI -17.43 to -7.76), although this may not be the case at eight weeks (low-quality evidence). Vitamin D supplementation regimens compared Two double-blind RCTs (83 participants) compared different regimens of vitamin D. One RCT (n = 62) compared oral vitamin D3 7000 IU/day to 4000 IU/day for 12 weeks, while the second RCT (n = 21) compared oral vitamin D3 100,000 IU/month to 12,000 IU/month for 24 months. Both RCTs had low risk of bias for blinding (of participants, personnel and outcome assessors) and incomplete outcome data, but the risk of selective outcome reporting bias was high. The bias from randomisation and allocation concealment was low in one study but not in the second. There was an unclear risk of other biases. When comparing oral vitamin D 100,000 IU/month to 12,000 IU/month, the higher dose may have resulted in higher serum 25(OH)D levels at one year, MD 16.40 (95% CI 12.59 to 20.21) and at two years, MD 18.96 (95% CI 15.20 to 22.72) (low-quality evidence). There was little or no difference in adverse events between doses (low-quality evidence). There were more episodes of acute chest syndrome in the high-dose group, at one year, MD 0.27 (95% CI 0.02 to 0.52) but there was little or no difference at two years, MD 0.09 (95% CI -0.04 to 0.22) (moderate-quality evidence). At one year and two years there was also little or no difference between the doses in the presence of pain (moderate-quality evidence) or forced expiratory volume in one second % predicted. However, the high-dose group had lower values for % predicted forced vital capacity at both one and two years, MD -7.20% predicted (95% CI -14.15 to -0.25) and MD -7.10% predicted (95% CI -14.03 to -0.17), respectively. There were little or no differences between dose regimens in the muscle health of either hand or the dominant hand. The study comparing oral vitamin D3 7000 IU/day to 4000 IU/day (21 participants) did not provide data for analysis, but median serum 25(OH)D levels were reported to be lower in the low-dose group at both six and 12 weeks. At 12 weeks the median serum parathyroid hormone level was lower in the high-dose group.
AUTHORS' CONCLUSIONS


We included three RCTs of varying quality. We consider that the current evidence presented in this review is not of sufficient quality to guide clinical practice. Until further evidence becomes available, clinicians should consider the relevant existing guidelines for vitamin D supplementation and dietary reference intakes for calcium and vitamin D. Well-designed RCTs of parallel design, are required to determine the effects and the safety of vitamin D supplementation as well as to assess the relative benefits of different doses in children and adults with SCD.",2020,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","['sickle cell disease', 'children and adults with SCD', 'people with SCD, of all ages, gender, and phenotypes']","['vitamin D. One RCT', 'vitamin D or placebo or no supplementation', 'Vitamin D supplementation', 'oral vitamin D3', 'vitamin D supplementation', 'oral vitamin D3 (cholecalciferol) supplementation', 'placebo']","['general health (e.g. growth status and health-related quality of life', 'musculoskeletal health (including bone mineral density, pain crises, bone fracture and muscle health), on respiratory health (including lung function, acute chest syndrome, acute exacerbation of asthma and respiratory infections', 'forced vital capacity', 'pain days', 'episodes of acute chest syndrome', 'presence of pain (moderate-quality evidence) or forced expiratory volume', 'adverse events (tingling of lips or hands', 'lower (worse) health-related quality of life score', 'adverse events', 'median serum parathyroid hormone level', 'median serum 25(OH)D levels', 'serum 25(OH)D levels']","[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0231225', 'cui_str': 'Pain crisis'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0742343', 'cui_str': 'Acute chest syndrome'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877487', 'cui_str': 'Tingling lips'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.658415,"There was little or no difference in adverse events (tingling of lips or hands) between the vitamin D and placebo groups, risk ratio 3.16 (95% CI 0.14 to 72.84) (low-quality evidence).","[{'ForeName': 'Htoo Htoo Kyaw', 'Initials': 'HHK', 'LastName': 'Soe', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College, Manipal Academy of Higher Education (MAHE), Melaka, Malaysia.'}, {'ForeName': 'Adinegara Bl', 'Initials': 'AB', 'LastName': 'Abas', 'Affiliation': 'Department of Community Medicine, Melaka-Manipal Medical College (Manipal Academy of Higher Education), Melaka, Malaysia.'}, {'ForeName': 'Nan Nitra', 'Initials': 'NN', 'LastName': 'Than', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Melaka-Manipal Medical College (MMMC), Manipal Academy of Higher Education(MAHE), Melaka, Malaysia.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': 'Faculty of Medicine, SEGi University, Sibu, Malaysia.'}, {'ForeName': 'Jaspal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Faculty of Medicine, Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Abdul Razzak Bin Mohd', 'Initials': 'ARBM', 'LastName': 'Said', 'Affiliation': 'Melaka-Manipal Medical College, Melaka, Malaysia.'}, {'ForeName': 'Ifeyinwa', 'Initials': 'I', 'LastName': 'Osunkwo', 'Affiliation': 'Comprehensive Sickle Cell Program, Aflac Cancer and Blood Disorders Service, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010858.pub3']
1218,32466660,Compound Danshen Dripping Pill Promotes Adaptation to Acute High-Altitude Exposure.,"Li, Zongbin, Jun Guo, Chunwei Liu, Yajun Shi, Yang Li, Jinli Wang, Dandan Li, Jing Wang, and Yundai Chen. Compound Danshen Dripping Pill promotes adaptation to acute high-altitude exposure.  High Alt Med Biol . 21:258-264, 2020.  Background:  In this study, we aimed to investigate whether the traditional Chinese medicine, Compound Danshen Dripping Pill (CDDP), can prevent acute mountain sickness (AMS). We allocated CDDP and matching placebos to 160 volunteers before they ascended to a high altitude. Treadmill exercise tests, echocardiography, blood routine examinations, biochemical analysis, and blood gas analysis were performed upon arrival at high altitude. The primary outcome included incidence of AMS, exercise times, and metabolic equivalents (METs) of treadmill exercise tests. Second endpoints included the heart rates and rate-pressure product (RPP) before and after treadmill exercise tests.  Results:  After high-altitude exposure, the incidence of AMS in the CDDP group was lower than that in the placebo group (48.6% vs. 67.6%,  p  = 0.022). The exercise time of the treadmill exercise test was significantly longer (507 ± 77.9 seconds vs. 457 ± 90.8 seconds,  p  = 0.004), the heart rate was lower (pre-exercise: 91.8 ± 11.7 beats/min vs. 97.2 ± 12.7 beats/min,  p  = 0.016; postexercise: 114 ± 22.2 beats/min vs. 121 ± 22.6 beats/min,  p  = 0.019), the pre-exercise and postexercise RPP were lower (pre-exercise: 1.13 × 10 4  ± 1.68 × 10 3  mmHg·beats/min vs. 1.23 × 10 4  ± 1.84 × 10 3  mmHg·beats/min,  p  = 0.027; postexercise: 1.19 × 10 4  ± 1.75 × 10 3  mmHg·beats/min vs. 1.31 × 10 4  ± 2.00 × 10 3  mmHg·beats/min,  p  = 0.002), and the MET value of the treadmill exercise test was significantly higher (9.93 ± 1.18 METs vs. 9.31 ± 1.52 METs,  p  = 0.037) in the CDDP group.  Discussion:  CDDP decreases the incidence of AMS and enhances exercise tolerance greater than placebo after high-altitude exposure. CDDP decreases the heart rate and myocardial oxygen consumption, increases the levels of hemoglobin, hematocrit, and antioxidant factors, and decreases the levels of inflammatory factors, which may explain the roles of CDDP in improving the adaptation to high-altitude exposure.",2020,"CDDP decreases the heart rate and myocardial oxygen consumption, increases the levels of hemoglobin, hematocrit, and antioxidant factors, and decreases the levels of inflammatory factors, which may explain the roles of CDDP in improving the adaptation to high-altitude exposure.","['160 volunteers before they ascended to a high altitude', 'acute mountain sickness (AMS']","['traditional Chinese medicine, Compound Danshen Dripping Pill (CDDP', 'CDDP', 'CDDP and matching placebos', 'placebo']","['incidence of AMS and enhances exercise tolerance', 'Treadmill exercise tests, echocardiography, blood routine examinations, biochemical analysis, and blood gas analysis', 'incidence of AMS, exercise times, and metabolic equivalents (METs) of treadmill exercise tests', 'heart rate', 'pre-exercise and postexercise RPP', 'exercise time of the treadmill exercise test', 'levels of hemoglobin, hematocrit, and antioxidant factors', 'heart rate and myocardial oxygen consumption', 'heart rates and rate-pressure product (RPP', 'incidence of AMS']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0377336', 'cui_str': 'dan-shen root extract'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1860224', 'cui_str': 'Ablepharon macrostomia syndrome'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0314205,"CDDP decreases the heart rate and myocardial oxygen consumption, increases the levels of hemoglobin, hematocrit, and antioxidant factors, and decreases the levels of inflammatory factors, which may explain the roles of CDDP in improving the adaptation to high-altitude exposure.","[{'ForeName': 'Zongbin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Chunwei', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Medical Center, Chinese PLA General Hospital, Beijing, China.'}]",High altitude medicine & biology,['10.1089/ham.2019.0126']
1219,32466678,Feasibility of Targeting Hispanic Fathers and Children in an Obesity Intervention:  Papás Saludables Niños Saludables .,"Background:  Hispanic children and men carry a high burden for obesity and associated medical conditions.  Healthy Dads Healthy Kids  was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia. The aim of this study was to assess the feasibility of a culturally adapted version of the program for Hispanic families,  Papás Saludables Niños Saludables .  Methods:  A randomized waitlist controlled trial with a process evaluation was conducted to assess the feasibility of  Papás Saludables Niños Saludables   ( NCT03532048). Fathers, their partner (mother), and one to three children were enrolled.  A priori  feasibility criteria were: (1) recruit 40 Hispanic fathers and their families in ≤4 months; (2) retain 80% of participants for pre- and postassessments; (3) maintain ≥70% attendance to the 10 sessions; (4) obtain 80% ""excellent"" or ""good"" satisfaction from participants; and (5) collect anthropometric and behavioral data on ≥75% of participants at baseline and follow-up.  Results:  The study enrolled 90% ( n  = 36) of the goal from one local pediatric clinic between May and August 2018; retained 75% of participants for postassessment; maintained 72% attendance among those who started the program; and achieved 100% ""excellent/good"" satisfaction ratings among the participating fathers and mothers. One hundred percent of participants had most anthropometric and behavioral data at baseline and 72% at follow-up.  Conclusions:  With oversampling and improvements in the recruitment strategies,  Papás Saludables Niños Saludables  is feasible for a randomized controlled clinical trial to address whether a father-targeted lifestyle program is efficacious among low-income Hispanic men and their children.",2020,Healthy Kids  was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia.,"['Healthy Dads', 'low-income Hispanic men and their children', 'Hispanic children and men carry a high burden for obesity and associated medical conditions', 'Hispanic Fathers and Children in an Obesity Intervention', 'fathers and children in Australia', '40 Hispanic fathers and their families in ≤4 months; (2) retain 80% of participants for pre- and postassessments; (3) maintain ≥70% attendance to the 10 sessions; (4', 'Hispanic families,  Papás Saludables Niños Saludables ', 'The study enrolled 90% ( n \u2009=\u200936) of the goal from one local pediatric clinic between May and August 2018; retained 75% of participants for postassessment; maintained 72% attendance among those who started the program; and achieved 100% ""excellent/good"" satisfaction ratings among the participating fathers and mothers', 'Fathers, their partner (mother), and one to three children were enrolled']","['obtain 80% ""excellent"" or ""good"" satisfaction from participants; and (5) collect anthropometric and behavioral data on ≥75% of participants at baseline and follow-up']",['weight loss'],"[{'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015670', 'cui_str': 'Father-Child Relationship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015671', 'cui_str': 'Father'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",90.0,0.0374602,Healthy Kids  was the first obesity prevention intervention targeting fathers and demonstrated weight loss among fathers and behavior change among fathers and children in Australia.,"[{'ForeName': 'Teresia M', 'Initials': 'TM', 'LastName': ""O'Connor"", 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Beltran', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Musaad', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Perez', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Flores', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Galdamez-Calderon', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Tasia', 'Initials': 'T', 'LastName': 'Isbell', 'Affiliation': 'School of Public Health, University of Texas, Houston, TX, USA.'}, {'ForeName': 'Elva M', 'Initials': 'EM', 'LastName': 'Arredondo', 'Affiliation': 'School of Public Health, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Parra Cardona', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Cabrera', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Marton', 'Affiliation': ""Texas Children's Health Plan, Houston, TX, USA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Baranowski', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine, USDA/ARS Children's Nutrition Research Center, Houston, TX, USA.""}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Morgan', 'Affiliation': 'Faculty of Education and Arts, Priority Research Center for Physical Activity and Nutrition, University of Newcastle, Newcastle, New South Wales, Australia.'}]",Childhood obesity (Print),['10.1089/chi.2020.0006']
1220,32472958,"Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial .","Rebound pain after brachial plexus block resolution and development of long-lasting pain are problems associated with volar plate fixation for distal radius fractures. The aim of this double-blind study was to evaluate the effect of a single prophylactic intravenous dose of dexamethasone in this setting. The primary endpoint was highest pain score during the first 24 hours after surgery. We included 51 adults of ASA physical status 1-2 due to undergo planned acute fixation of the radius. All received premedication with oral paracetamol and etoricoxib, and a pre-operative brachial plexus block with ropivacaine. Patients were randomly allocated into two groups: a dexamethasone group receiving 16 mg dexamethasone intravenously at start of surgery and a control group receiving 4 ml saline. After surgery, all patients received fixed doses of paracetamol, etoricoxib and oxycodone, with further oxycodone added as needed in the first 48 hours. Pain, analgesic consumption and daily function were registered at predefined times up to 1 year after surgery. Median (IQR [range]) worst pain score in the first 24 hours, as assessed by verbal numeric rating scale (0-10), was 4 (2-6 [0-7]) in the dexamethasone group compared with 8 (5-8 [2-10]) in the placebo group (p < 0.001). Average pain score, 2 (1-4 [0-5]) vs. 5 (3-6 [0-8]), p = 0.001 and rescue oxycodone consumption, 5 (0-10 [0-35]) mg vs. 10 (5-15 [0-50]) mg, p = 0.037), respectively, were both significantly lower in the dexamethasone group compared with control from 8 to 24 hours. Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6]) hours, p < 0.001. Two patients (9%) in the dexamethasone group compared with 12 (50%) in the placebo group experienced worst pain scores of 8-10 during the first 36 hours (p = 0.002). At 3 and 7 days postoperatively, there were no significant differences between groups for pain scores or opioid consumption. At 6 months, 27 patients (57%) reported pain at the site of surgery, with significantly higher average pain score (p = 0.024) in the placebo group. At 1 year, two patients in the dexamethasone group reported pain compared with 10 in the placebo group (p = 0.015), and worst pain score was significantly higher in the placebo group (p = 0.018). We conclude that intravenous dexamethasone improves early postoperative analgesia and may also improve clinical outcomes after 6 and 12 months.",2020,"Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6])","['distal radius fracture with brachial plexus block anaesthesia', '51 adults of ASA physical status 1-2 due to undergo planned acute fixation of the radius']","['volar plate fixation', 'dexamethasone group receiving 16\xa0mg dexamethasone', 'dexamethasone', 'volar plate surgery', 'ropivacaine', 'control group receiving 4\xa0ml saline', 'intravenous dexamethasone', 'paracetamol, etoricoxib and oxycodone, with further oxycodone', 'oral paracetamol and etoricoxib', 'placebo']","['Pain, analgesic consumption and daily function', 'Analgesic effect', 'early postoperative analgesia', 'verbal numeric rating scale', 'clinical outcomes', 'worst pain scores', 'highest pain score', 'average pain score', 'Brachial plexus block duration', 'Rebound pain', 'Median (IQR [range]) worst pain score', 'pain scores or opioid consumption', 'pain', 'worst pain score', 'Average pain score']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}]","[{'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0972314', 'cui_str': 'etoricoxib'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",51.0,0.547037,"Brachial plexus block duration was 69% longer in the dexamethasone group, 21.5 (19.1-23.4 [12.9-24.1]) hours vs. 12.7 (11.9-15.3 [7.4-26.6])","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Holmberg', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Hassellund', 'Affiliation': 'Department of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Draegni', 'Affiliation': 'Department of Research and Development, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nordby', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Ottesen', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gulestøl', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Raeder', 'Affiliation': 'Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway.'}]",Anaesthesia,['10.1111/anae.15111']
1221,32469625,A case series of suprascapular nerve block (with an historical comparator) for shoulder pain in motor neurone disease.,"BACKGROUND


Shoulder pain is a distressing but under-reported and poorly managed symptom in people with motor neurone disease.
OBJECTIVES


This study aimed to assess the efficacy of suprascapular nerve block for the management of shoulder pain in patients with motor neurone disease.
METHODS


A total of 27 patients with motor neurone disease and shoulder pain were offered a suprascapular nerve block. Ten of these patients had bilateral shoulder pain and both were injected, making a total of 37 shoulders. The patients were followed up for a total of 3 months, or until death. Shoulder pain was measured using the pain scale (out of 100) of the shoulder pain and disability index and compared with baseline scores and a placebo control group from an earlier study using the same methodology (ACTRN12619000353190).
RESULTS


Following the nerve block there was a significant improvement of pain scores from baseline (58.4) at week 1 (20.8,  p  < 0.000), week 6 (17.6,  p  < 0.000) and week 12 (30.4,  p  = 0.001) and a significant improvement compared with the control group across each time interval.
CONCLUSION


Suprascapular nerve block is a safe, effective therapy for patients with chronic shoulder pain.",2020,"Following the nerve block there was a significant improvement of pain scores from baseline (58.4) at week 1 (20.8,  p  < 0.000), week 6 (17.6,  p  < 0.000) and week 12 (30.4,  p  = 0.001) and a significant improvement compared with the control group across each time interval.
","['shoulder pain in motor neurone disease', 'patients with motor neurone disease', 'patients with chronic shoulder pain', 'people with motor neurone disease', '27 patients with motor neurone disease and shoulder pain']","['Suprascapular nerve block', 'suprascapular nerve block (with an historical comparator', 'suprascapular nerve block']","['pain scores', 'shoulder pain and disability index', 'Shoulder pain', 'bilateral shoulder pain', 'pain scale']","[{'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0085084', 'cui_str': 'Motor neuron disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",27.0,0.133856,"Following the nerve block there was a significant improvement of pain scores from baseline (58.4) at week 1 (20.8,  p  < 0.000), week 6 (17.6,  p  < 0.000) and week 12 (30.4,  p  = 0.001) and a significant improvement compared with the control group across each time interval.
","[{'ForeName': 'E Michael', 'Initials': 'EM', 'LastName': 'Shanahan', 'Affiliation': 'Department of Rheumatology, Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Glaezter', 'Affiliation': 'Department of Rheumatology, Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Gill', 'Affiliation': 'Discipline of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hill', 'Affiliation': 'Discipline of Medicine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Graf', 'Affiliation': 'Department of Rheumatology, Flinders University and Flinders Medical Centre, Adelaide, SA, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Allcroft', 'Affiliation': 'Southern Adelaide Local Health Network, Adelaide, SA, Australia.'}]",Palliative medicine,['10.1177/0269216320929553']
1222,32475079,Mepitel Film is superior to Biafine cream in managing acute radiation-induced skin reactions in head and neck cancer patients: a randomised intra-patient controlled clinical trial.,"INTRODUCTION


We previously showed that Mepitel Film decreased the severity of acute radiation-induced skin reactions in head and neck cancer patients. In the current study, we compared the effect of Mepitel Film and Biafine cream on skin reaction severity in a larger cohort of head and neck cancer patients.
METHODS


A total of 44 head and neck cancer patients were recruited with 39 patients contributing full data sets for analysis. Patients received a dose of 50 Gy in 25 fractions to the bilateral lymph nodes in the neck. Left and right lymph node areas were randomised to either Mepitel Film or Biafine cream, applied prophylactically. Skin reaction severity was measured using Radiation-Induced Skin Reaction Assessment Scale (RISRAS) and expanded Radiation Oncology group (RTOG) grades. Skin dose was measured using gafchromic Film.
RESULTS


Skin reaction severity (combined RISRAS score) underneath Mepitel Film was decreased by 30% (P < 0.001) and moist desquamation rates by 41% (P < 0.001). Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity. The vast majority (80%) of patients preferred Mepitel Film over Biafine cream. Negative aspects of Mepitel Film included poor adherence (11/39) and discomfort (16/39) during hot weather and showering and itchy skin underneath Mepitel Film (12/39).
CONCLUSIONS


Mepitel Film was superior to Biafine cream in reducing the severity of acute radiation-induced skin reactions and moist desquamation incidence in our head and neck patient cohort.",2020,Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity.,"['larger cohort of head and neck cancer patients', 'head and neck cancer patients', 'Left and right lymph node areas', '44 head and neck cancer patients were recruited with 39 patients contributing full data sets for analysis']","['Biafine cream', 'Skin dose underneath Mepitel Film and Biafine cream', 'Mepitel Film or Biafine cream', 'Mepitel Film and Biafine cream']","['Skin reaction severity (combined RISRAS score) underneath Mepitel Film', 'severity of acute radiation-induced skin reactions', 'skin reaction severity', 'Radiation-Induced Skin Reaction Assessment Scale (RISRAS', 'Skin reaction severity', 'moist desquamation rates']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0677828', 'cui_str': 'Biafine'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0758246', 'cui_str': 'mepitel'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0758246', 'cui_str': 'mepitel'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}]",,0.0289646,Skin dose underneath Mepitel Film and Biafine cream was similar (P = 0.925) and unlikely to have affected skin reaction severity.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Shuangshuang', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Yao', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Kongcheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Comprehensive Cancer Centre, Drum Tower Hospital/Clinical Cancer Institute of Nanjing University, Nanjing, China.'}, {'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand.'}]",Journal of medical radiation sciences,['10.1002/jmrs.397']
1223,32484533,Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.,"Importance


Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates.
Objective


To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality.
Design, Setting, and Participants


Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019.
Interventions


Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743).
Main Outcomes and Measures


The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality.
Results


Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important).
Conclusions and Relevance


Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.",2020,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","['1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n\u2009=\u2009735 in both randomization groups) and were included in the analysis', 'women with 1 previous cesarean delivery', 'A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019']","[""tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool"", 'patient-centered decision support tool', 'Patient-Centered Decision Support Tool']","['labor; vaginal birth', 'labor rates', 'cesarean delivery rates', '5 decision quality measures (eg, mean decisional conflict scores', 'Rates of Trial of Labor', 'rate of trial of labor', 'rates of trial of labor and vaginal birth', 'vaginal birth rates', 'maternal and neonatal outcomes and decision quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.215832,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Anjali J', 'Initials': 'AJ', 'LastName': 'Kaimal', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Blat', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Mari-Paule', 'Initials': 'MP', 'LastName': 'Thiet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Yamilee', 'Initials': 'Y', 'LastName': 'Bermingham', 'Affiliation': 'Marin Community Clinic, San Rafael, California.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Altshuler', 'Affiliation': 'California Pacific Medical Center, San Francisco.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bryant', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2020.5952']
1224,32572439,Biomarkers of orthodontic tooth movement with fixed appliances and vibration appliance therapy: a pilot study.,"INTRODUCTION


The aim of this study was to investigate the effect of supplemental vibratory force on biomarkers of bone remodelling during orthodontic tooth movement, the rate of mandibular anterior alignment (RMAA), and compliance with a vibration device.
DESIGN, SETTINGS, AND PARTICIPANTS


Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic were randomly allocated to supplemental use of an intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance only (n = 20). Salivary multiplex assay was completed to analyse the concentration of selected biomarkers of bone remodelling before treatment (T0) and at three following time points (T1, T2, T3), 4-6 weeks apart. Irregularity of the mandibular anterior teeth and compliance was assessed at the same trial time points. Data were analysed blindly on an intention-to-treat basis with descriptive statistics, Mann-Whitney U-test, Wilcoxon signed-rank test, and linear mixed effects regression modelling.
RESULTS


No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed. No correlation was found between changes in irregularity and biomarker level from baseline to another time point. Lastly, there was no association between RMAA and compliance with the AcceleDent® device.
CONCLUSIONS


Supplemental vibratory force during orthodontic treatment with fixed appliances does not affect biomarkers of bone remodelling or the RMAA.
LIMITATIONS


The main limitation of the study was the small sample size and the large variability in the salivary biomarkers.
HARMS


No harms were observed during the duration of the trial.
PROTOCOL


The protocol was not published prior to trial commencement.
REGISTRATION


The study was registered in Clinical Trials.gov (NCT02119455) first posted on April 2014.",2020,No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed.,['Forty patients between the ages 15-35 undergoing fixed appliance treatment that presented to a university orthodontic clinic'],"['fixed appliances and vibration appliance therapy', 'intraoral vibrational device (n = 20, AcceleDent®) or fixed appliance', 'supplemental vibratory force']","['salivary biomarkers of bone remodelling and RMAA', 'rate of mandibular anterior alignment (RMAA), and compliance with a vibration device', 'irregularity and biomarker level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443221', 'cui_str': 'Forced'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",40.0,0.100189,No difference in the changes in salivary biomarkers of bone remodelling and RMAA between groups at any time point over the trial duration was observed.,"[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Reiss', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Marie Claude', 'Initials': 'MC', 'LastName': 'Chouinard', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Dasha', 'Initials': 'D', 'LastName': 'Frias Landa', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Nanda', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Taranpreet', 'Initials': 'T', 'LastName': 'Chandhoke', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Sobue', 'Affiliation': 'Division of Periodontics, Department of Oral Health and Diagnostic Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Veerasathpurush', 'Initials': 'V', 'LastName': 'Allareddy', 'Affiliation': 'Department of Orthodontics, College of Dentistry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chia-Ling', 'Initials': 'CL', 'LastName': 'Kuo', 'Affiliation': 'CICATS/Department of Community Medicine/Institute for System Genomics, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Jinjian', 'Initials': 'J', 'LastName': 'Mu', 'Affiliation': 'CICATS/Department of Community Medicine/Institute for System Genomics, University of Connecticut Health, Farmington, CT, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Uribe', 'Affiliation': 'Division of Orthodontics, Department of Craniofacial Sciences, School of Dental Medicine, University of Connecticut Health, Farmington, CT, USA.'}]",European journal of orthodontics,['10.1093/ejo/cjaa026']
1225,32568810,Evaluation of Evidence-Based Guidelines for Fever Management in Critically Ill Adult Patients With Brain Injury.,"PURPOSE


The aim of this study was to evaluate the effectiveness of evidence-based guidelines for fever management of critically ill adult patients with brain injury.
METHODS


We used a pretest-posttest design with 48 patients 19 years or older admitted to an intensive care unit after surgery for brain injury. We applied evidence-based guidelines only to an experimental group of 24 patients and compared with 24 control patients who did not receive evidence-based guidelines. Experimental and control groups were matched 1:1 using the Acute Physiology and Chronic Health Evaluation II score. Data included the proportion of patients with reduced fever and time to normalized temperature.
RESULTS


The proportion of patients whose temperature fell to normal after fever was 4.5 times higher in the experimental group than in the control group. The time it took the patients' highest fever to fall to normal during their intensive care unit stay was 4.84 times faster in the experimental group than in the control group (hazard ratio, 4.84; 95% confidence interval, 1.79-13.11; P = .002).
CONCLUSION


Evidence-based guidelines for fever management in patients with a brain injury can be used in nursing practice with rapid response, improving healthcare efficiency and contributing to better outcomes for critically ill patients.",2020,The proportion of patients whose temperature fell to normal after fever was 4.5 times higher in the experimental group than in the control group.,"['critically ill patients', '24 patients and compared with 24 control patients who did not receive evidence-based guidelines', 'critically ill adult patients with brain injury', 'patients with a brain injury', '48 patients 19 years or older admitted to an intensive care unit after surgery for brain injury', 'Critically Ill Adult Patients With Brain Injury']",[],['temperature fell to normal after fever'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",[],"[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.0836794,The proportion of patients whose temperature fell to normal after fever was 4.5 times higher in the experimental group than in the control group.,"[{'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Jung Min Lee, RN, is Staff Nurse, Neurosurgery Intensive Care Unit, Department of Nursing, Samsung Medical Center; and Doctoral Candidate, College of Nursing, The Catholic University of Korea, Seoul, South Korea. Hye Jeong Kim, is Unit Manager, Department of Nursing, Samsung Medical Center, Seoul, South Korea. Do Yeon Kwon, RN, is Staff Nurse, Neurosurgery Intensive Care Unit, Department of Nursing, Samsung Medical Center, Seoul, South Korea. Ja Young Shin, RN, is Staff Nurse, Neurosurgery Intensive Care Unit, Department of Nursing, Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ju Ryoung', 'Initials': 'JR', 'LastName': 'Moon', 'Affiliation': ''}, {'ForeName': 'Hye Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Do Yeon', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': ''}, {'ForeName': 'Ja Young', 'Initials': 'JY', 'LastName': 'Shin', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000524']
1226,32578775,Cefazolin sodium pentahydrate combined with vacuum sealing drainage in the treatment of open fracture complicated with soft tissue injury.,"OBJECTIVE


To investigate the clinical efficacy of cefazolin sodium pentahydrate combined with vacuum sealing drainage (VSD) in the treatment of open fracture complicated with soft tissue injury.
METHODS


Sixty-three patients with open fracture complicated with soft tissue injury were divided into observation (n = 33) and control (n = 30) groups. After surgical reduction, fixation, and repair of the fractures, the control group was treated with VSD for 10 days, and the observation group was treated with cefazolin sodium pentahydrate based on VSD for 10 days. The infection control time was recorded. After treatment, the pain of patients was evaluated. Before and after treatment, the serum levels of C-reactive protein (CRP), interleukin (IL)-6, IL-8, tumor necrosis factor α (TNF-α), cortisol, epinephrine, norepinephrine, and glucose were detected. After 6 months of treatment, the total effective rate of the treatment was evaluated.
RESULTS


The infection control time and Visual Analogue Scale score after treatment in the observation group were significantly lower than in the control group, respectively (P < 0.05). After the treatment, the serum levels of CRP, IL-6, IL-8, TNF-α, cortisol, epinephrine, norepinephrine, and glucose in each group were significantly lower than before the treatment (P < 0.05), and each index in observation was significantly lower than in the control group (P < 0.05).
CONCLUSIONS


In the treatment of open fractures complicated with soft tissue injury, cefazolin sodium pentahydrate combined with VSD can effectively reduce inflammation and stress, thus improving the treatment efficacy.",2020,"The infection control time and Visual Analogue Scale score after treatment in the observation group were significantly lower than in the control group, respectively (P < 0.05).","['Sixty-three patients with open fracture complicated with soft tissue injury were divided into observation (n = 33) and control (n = 30) groups', 'open fracture complicated with soft tissue injury']","['cefazolin sodium pentahydrate combined with VSD', 'Cefazolin sodium pentahydrate combined with vacuum sealing drainage', 'cefazolin sodium pentahydrate combined with vacuum sealing drainage (VSD', 'cefazolin sodium pentahydrate', 'VSD']","['serum levels of C-reactive protein (CRP), interleukin (IL)-6, IL-8, tumor necrosis factor α (TNF-α), cortisol, epinephrine, norepinephrine, and glucose', 'total effective rate', 'index in observation', 'fixation, and repair of the fractures', 'serum levels of CRP, IL-6, IL-8, TNF-α, cortisol, epinephrine, norepinephrine, and glucose', 'infection control time and Visual Analogue Scale score', 'infection control time']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0700526', 'cui_str': 'Cefazolin sodium'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",63.0,0.0136703,"The infection control time and Visual Analogue Scale score after treatment in the observation group were significantly lower than in the control group, respectively (P < 0.05).","[{'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zou', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Zhongbin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Che', 'Affiliation': '. Department of Orthopedics, General Hospital of the Yangtze River Shipping and Wuhan Brain Hospital, Wuhan 430010, China.'}]",Revista da Associacao Medica Brasileira (1992),['10.1590/1806-9282.66.4.430']
1227,32574773,Macular and Peripapillary Optical Coherence Tomography Angiography Metrics Predict Progression in Diabetic Retinopathy: A Sub-analysis of TIME-2b Study Data.,"PURPOSE


To identify optical coherence tomography angiography (OCTA)-derived vessel metrics of the macula and optic nerve head (ONH) that predict diabetic retinopathy (DR) disease progression.
DESIGN


Secondary analysis of clinical trial data.
METHODS


This was a sub-analysis of prospectively collected data from 73 subjects that participated in the TIME-2b study (Aerpio Pharmaceuticals), a multicenter clinical trial for patients with moderate-to-severe DR treated with AKB-9778 and followed over a 12-month period. Eligible subjects were tested every 3 months with color fundus photography, spectral-domain OCT, and slit-lamp biomicroscopy. OCTA of the macula and ONH was obtained for a subset of patients enrolled at participating sites. En face, full-depth retinal projections centered at the macula were analyzed for multiple metrics including foveal avascular zone (FAZ) area and perimeter, nonperfusion area, vessel density (VD), and presence of intraretinal microvascular abnormalities (IRMA). VD of the radial peripapillary capillaries was evaluated in 4 quadrants surrounding the optic disc for ONH images. Progression was defined as a ≥2-step increase in DR severity scale score or development of diabetic macular edema.
RESULTS


Over a follow-up period of 12 months, 15 of 73 (20.5%) subjects progressed. At pretreatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
CONCLUSIONS


FAZ area and temporal peripapillary VD are predictors of DR progression. OCTA metrics may improve progression risk assessment in DR when compared to established risk factors alone.",2020,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","['Diabetic Retinopathy', '73 subjects that participated in the TIME-2b Study (Aerpio Pharmaceuticals), a multi-center clinical trial for patients with moderate to severe DR treated with AKB-9778 and followed over a 12-month period']","['color fundus photography, spectral domain OCT and slit-lamp biomicroscopy', 'optical coherence tomography angiography (OCTA']","['larger FAZ area, presence of IRMA, and reduced peripapillary VD', 'DR severity scale score or development of diabetic macular edema', 'foveal avascular zone (FAZ) area and perimeter, non-perfusion area, vessel density (VD) and presence of intraretinal microvascular abnormalities (IRMA']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4043862', 'cui_str': 'AKB-9778'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3714733', 'cui_str': 'Intraretinal microvascular abnormality'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0442163', 'cui_str': 'Peripapillary'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",73.0,0.0248145,"At pre-treatment baseline, larger FAZ area, presence of IRMA, and reduced peripapillary VD in the superior temporal and inferior temporal regions were significantly associated with increased odds of progression.
","[{'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Custo Greig', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Brigell', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Cao', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Levine', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA; Tufts University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': 'Aerpio Pharmaceuticals, Cincinnati, Ohio, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Moult', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Fujimoto', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Nadia K', 'Initials': 'NK', 'LastName': 'Waheed', 'Affiliation': 'New England Eye Center, Boston, Massachusetts, USA. Electronic address: nadiakwaheed@gmail.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.009']
1228,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
OBJECTIVES


To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
METHODS


240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.
CONCLUSIONS


If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061']
1229,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION


Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.
METHODS


The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.
DISCUSSION


Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.
TRIAL REGISTRATION


This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067']
1230,32446770,Using Self-Reported Measures of Confidence and Anxiety to Determine the Efficacy of the Surgical Exploration And Discovery (SEAD) Program in Reducing Anxiety and Increasing Confidence in Performing Procedural Skills.,"OBJECTIVE


Clerkship students feel increased anxiety and lack of confidence when it comes to surgery. This study assessed whether participation in Surgical Exploration And Discovery (SEAD), a 2-week intensive surgical program that includes career information, simulation workshops, and operating room observerships, would help decrease anxiety, increase confidence, and foster interest in a surgical career.
SETTING


This study took place at The Ottawa Hospital in Ottawa, Ontario, Canada.
DESIGN


Thirty first year medical students were randomly selected for the SEAD program and 32 were only given the program's instruction manual during the duration of the program serving as the control. At baseline and after the completion of SEAD, both groups were given a survey containing the State Trait Anxiety Inventory that measures self-reported anxiety levels with an adjunct that gauges confidence and interest in a surgical career.
RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001). However, there was no difference in the average state anxiety with procedural skills (p-value = 0.190) between students who participated in SEAD and those who did not. Students who completed SEAD had a notable increase in their interest in pursuing a career in surgery compared with their pretest (p-value = 0.020) and compared with the control group (p-value = 0.600).
CONCLUSIONS


The SEAD program may increase medical students' confidence and interest in pursuing a surgical career. These results encourage offering medical students with similar opportunities that provide exposure to surgery in preclerkship.",2020,"RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001).","['Thirty first year medical students', 'place at The Ottawa Hospital in Ottawa, Ontario, Canada']","['Surgical Exploration And Discovery (SEAD', 'Surgical Exploration And Discovery (SEAD) Program', ""SEAD program and 32 were only given the program's instruction manual during the duration of the program serving as the control""]","['surgical assisting', 'maintaining sterility', 'State Trait Anxiety Inventory that measures self-reported anxiety levels', 'self-perceived knowledge and confidence for each surgical skill: scrubbing', 'average state anxiety with procedural skills']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0184899', 'cui_str': 'Exploratory incision'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",,0.0163054,"RESULTS


Students who participated in the program showed significant improvements in self-perceived knowledge and confidence for each surgical skill: scrubbing (p-value < 0.001, p-value < 0.001), maintaining sterility (p-value < 0.001, p-value < 0.001), and surgical assisting (p-value < 0.001, p-value < 0.001).","[{'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Market', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: mmark030@uottawa.ca.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Battaglia', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: fbatt066@uottawa.ca.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Langlois', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: elang086@uottawa.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada. Electronic address: jshin059@uottawa.ca.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Seabrook', 'Affiliation': 'The Ottawa Hospital, Department of Surgery, Division of Vascular Surgery, Ottawa, Ontario, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Brandys', 'Affiliation': 'The Ottawa Hospital, Department of Surgery, Division of Vascular Surgery, Ottawa, Ontario, Canada.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.03.010']
1231,32453377,"Safety, Tolerability, and Efficacy of Viltolarsen in Boys With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A Phase 2 Randomized Clinical Trial.","Importance


An unmet need remains for safe and efficacious treatments for Duchenne muscular dystrophy (DMD). To date, there are limited agents available that address the underlying cause of the disease.
Objective


To evaluate the safety, tolerability, and efficacy of viltolarsen, a novel antisense oligonucleotide, in participants with DMD amenable to exon 53 skipping.
Design, Setting, and Participants


This phase 2 study was a 4-week randomized clinical trial for safety followed by a 20-week open-label treatment period of patients aged 4 to 9 years with DMD amenable to exon 53 skipping. To enroll 16 participants, with 8 participants in each of the 2 dose cohorts, 17 participants were screened. Study enrollment occurred between December 16, 2016, and August 17, 2017, at sites in the US and Canada. Data were collected from December 2016 to February 2018, and data were analyzed from April 2018 to May 2019.
Interventions


Participants received 40 mg/kg (low dose) or 80 mg/kg (high dose) of viltolarsen administered by weekly intravenous infusion.
Main Outcomes and Measures


Primary outcomes of the trial included safety, tolerability, and de novo dystrophin protein production measured by Western blot in participants' biceps muscles. Secondary outcomes included additional assessments of dystrophin mRNA and protein production as well as clinical muscle strength and function.
Results


Of the 16 included boys with DMD, 15 (94%) were white, and the mean (SD) age was 7.4 (1.8) years. After 20 to 24 weeks of treatment, significant drug-induced dystrophin production was seen in both viltolarsen dose cohorts (40 mg/kg per week: mean [range] 5.7% [3.2-10.3] of normal; 80 mg/kg per week: mean [range] 5.9% [1.1-14.4] of normal). Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug. No serious adverse events or deaths occurred during the study. Compared with 65 age-matched and treatment-matched natural history controls, all 16 participants treated with viltolarsen showed significant improvements in timed function tests from baseline, including time to stand from supine (viltolarsen: -0.19 s; control: 0.66 s), time to run/walk 10 m (viltolarsen: 0.23 m/s; control: -0.04 m/s), and 6-minute walk test (viltolarsen: 28.9 m; control: -65.3 m) at the week 25 visit.
Conclusions and Relevance


Systemic treatment of participants with DMD with viltolarsen induced de novo dystrophin production, and clinical improvement of timed function tests was observed.
Trial Registration


ClinicalTrials.gov Identifier: NCT02740972.",2020,"Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug.","['To enroll 16 participants, with 8 participants in each of the 2 dose cohorts, 17 participants were screened', 'Boys', '16 included boys with DMD, 15 (94%) were white, and the mean (SD) age was 7.4 (1.8) years', 'participants with DMD with', 'participants with DMD amenable to exon 53 skipping', 'patients aged 4 to 9 years with DMD amenable to exon 53 skipping', 'Data were collected from December 2016 to February 2018, and data were analyzed from April 2018 to May 2019', 'Exon 53 Skipping']","['viltolarsen', 'viltolarsen administered by weekly intravenous infusion']","['serious adverse events or deaths', 'additional assessments of dystrophin mRNA and protein production as well as clinical muscle strength and function', 'Safety, Tolerability, and Efficacy of Viltolarsen', ""safety, tolerability, and de novo dystrophin protein production measured by Western blot in participants' biceps muscles"", 'safety, tolerability, and efficacy', 'timed function tests', 'dystrophin production']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0079259', 'cui_str': 'Dystrophin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",17.0,0.134131,"Viltolarsen was well tolerated; no treatment-emergent adverse events required dose reduction, interruption, or discontinuation of the study drug.","[{'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Clemens', 'Affiliation': 'Department of Neurology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vamshi K', 'Initials': 'VK', 'LastName': 'Rao', 'Affiliation': ""Division of Neurology, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Connolly', 'Affiliation': ""Division of Neurology, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus.""}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Harper', 'Affiliation': ""Children's Hospital of Richmond at Virginia Commonwealth University, Richmond.""}, {'ForeName': 'Jean K', 'Initials': 'JK', 'LastName': 'Mah', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Smith', 'Affiliation': 'Division of Pediatric Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Department of Pediatrics, UC Davis Health, University of California, Davis, Sacramento.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'Zaidman', 'Affiliation': 'Department of Neurology, Washington University at St Louis, St Louis, Missouri.'}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Morgenroth', 'Affiliation': 'Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Osaki', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Youhei', 'Initials': 'Y', 'LastName': 'Satou', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'NS Pharma, Paramus, New Jersey.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Hoffman', 'Affiliation': 'AGADA BioSciences, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.1264']
1232,32451827,Paracetamol versus Ibuprofen for the Acute Treatment of Migraine Headache in Children: A Blinded Randomized Controlled Trial.,"OBJECTIVE


To compare the efficacy of oral paracetamol and oral ibuprofen for the management of acute headache in children with migraine without aura.
METHODS


This randomized-controlled trial was done at the Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria. The 50 patients (21 females, mean age 9.9 y) consecutively enrolled were randomized by block randomization to two study groups, with one group (n = 25) receiving oral paracetamol (15 mg/kg/dose) and the other group (n = 25) oral ibuprofen (10 mg/kg/dose), at home, during a single episode of acute migraine headache. The study drugs were dispensed in a blinded fashion. Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief (≥2-point reduction from the baseline) two-hours after the study drug intake were the primary outcomes. Side-effects to the study drugs were actively solicited. Non-parametric tests for paired data were used.
RESULTS


The two groups were similar at baseline. Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study. Both pain-freedom (32% vs. 28%, P = 0.77) and pain-relief (80% vs. 80%, P = 0.86) were not significantly different between the Paracetamol and Ibuprofen groups, respectively. Ten (23.2%) children had a side-effect due to the study drug, with no significant difference between the groups (13.6% vs. 33.3%; P = 0.11).
CONCLUSIONS


Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.",2020,Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.,"['acute migraine attacks in children', '50 patients (21 females, mean age 9.9 y) consecutively enrolled', 'Migraine Headache in Children', 'children with migraine without aura', 'Pediatric department of a public hospital in India between 20 May, 2017 and 22 March, 2018, and enrolled children (aged 6-12 y) with Migraine without aura as per International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria', 'Forty-three children (22 paracetamol group and 21 ibuprofen group) completed the study']","['ibuprofen', 'paracetamol and ibuprofen', 'Ibuprofen', 'Paracetamol versus Ibuprofen', 'oral paracetamol and oral ibuprofen', 'oral paracetamol']","['pain-relief', 'Pain-freedom (score of zero in a 0-10 Visual analogue pain scale) and Pain-relief', 'pain-freedom', 'acute headache']","[{'cui': 'C1740836', 'cui_str': 'Acute migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0338480', 'cui_str': 'Migraine without aura'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}]",43.0,0.160754,Both paracetamol and ibuprofen are effective and safe for the treatment of acute migraine attacks in children.,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pavithra', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}, {'ForeName': 'Devendra', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India. drdmishra@gmail.com.'}, {'ForeName': 'Shatrishna', 'Initials': 'S', 'LastName': 'Behera', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Juneja', 'Affiliation': 'Neurology Clinic, Department of Pediatrics, Maulana Azad Medical College (University of Delhi) and associated Lok Nayak Hospital, 2, BSZ Marg, Delhi, 110002, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03315-x']
1233,32458091,Executive function training in very preterm children: a randomized controlled trial.,"Objective of the current study was to assess whether game-formatted executive function (EF) training, is effective in improving attention, EF and academic performance in very preterm and/or extremely low birthweight children aged 8-12 years. A multi-center, double-blind, placebo- and waitlist controlled randomized trial (NTR5365) in two academic hospitals in The Netherlands was performed. Eighty-five very preterm children with parent-rated attention problems on the Child Behavior Checklist were randomized to one of three treatment conditions: EF training, placebo training or waitlist condition. EF or placebo training was completed at home (6 weeks, 25 sessions of 30-45 min each). At baseline, 2 weeks after training or being on the waitlist, and five months after first follow-up visit, children underwent assessments of primary outcomes (parent and teacher ratings of attention) and secondary outcomes (parent and teacher ratings of daily-life EF, computerized EF tasks and academic performance). Linear mixed model analyses were performed for all outcome measures. There were no significant differences in improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading) between the EF training, placebo training and waitlist condition. In conclusion, game-formatted EF training does not improve attention, EF or academic performance in very preterm children with parent-rated attention problems.",2020,"There were no significant differences in improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading) between the EF training, placebo training and waitlist condition.","['very preterm children', 'very preterm and/or extremely low birthweight children aged 8-12\xa0years', 'Eighty-five very preterm children with parent-rated attention problems on the Child Behavior Checklist', 'two academic hospitals in The Netherlands was performed', 'very preterm children with parent-rated attention problems']","['game-formatted EF training', 'Executive function training', 'EF training, placebo training or waitlist condition', 'EF or placebo', 'game-formatted executive function (EF) training', 'placebo']","['attention, EF or academic performance', 'improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading', 'attention, EF and academic performance', 'teacher ratings of attention) and secondary outcomes (parent and teacher ratings of daily-life EF, computerized EF tasks and academic performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0589092', 'cui_str': 'Executive functions training'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",85.0,0.465743,"There were no significant differences in improvement over time on parent- and teacher ratings of attention, parent- and teacher ratings of daily-life EF, computerized EF tasks, and academic performance (arithmetic and reading) between the EF training, placebo training and waitlist condition.","[{'ForeName': 'Carolien A', 'Initials': 'CA', 'LastName': 'van Houdt', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. c.a.vanhoudt@amsterdamumc.nl.""}, {'ForeName': 'Aleid G', 'Initials': 'AG', 'LastName': 'van Wassenaer-Leemhuis', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': ""Department of Pediatrics, Amsterdam UMC, University of Amsterdam, Emma Neuroscience Group at Emma Children's Hospital, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Marsh', 'Initials': 'M', 'LastName': 'Königs', 'Affiliation': ""Emma Neuroscience Group, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Koopman-Esseboom', 'Affiliation': 'Department of Neonatology, University Medical Center Utrecht, Heidelberglaan 100, Utrecht, The Netherlands.'}, {'ForeName': 'A R Céleste', 'Initials': 'ARC', 'LastName': 'Laarman', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, de Boelelaan 1117, Amsterdam, The Netherlands.""}, {'ForeName': 'Anton H', 'Initials': 'AH', 'LastName': 'van Kaam', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}, {'ForeName': 'Cornelieke S H', 'Initials': 'CSH', 'LastName': 'Aarnoudse-Moens', 'Affiliation': ""Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.""}]",European child & adolescent psychiatry,['10.1007/s00787-020-01561-0']
1234,32462427,Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial.,"While preclinical stroke studies have shown that mesenchymal stem cells (MSCs) promote recovery, few randomized controlled trials (RCT) have assessed cell therapy in humans. In this RCT, we assessed the safety, feasibility, and efficacy of intravenous autologous bone marrow-derived MSCs in subacute stroke. ISIS-HERMES was a single-center, open-label RCT, with a 2-year follow-up. We enrolled patients aged 18-70 years less than 2 weeks following moderate-severe ischemic carotid stroke. Patients were randomized 2:1 to receive intravenous MSCs or not. Primary outcomes assessed feasibility and safety. Secondary outcomes assessed global and motor recovery. Passive wrist movement functional MRI (fMRI) activity in primary motor cortex (MI) was employed as a motor recovery biomarker. We compared ""treated"" and ""control"" groups using as-treated analyses. Of 31 enrolled patients, 16 patients received MSCs. Treatment feasibility was 80%, and there were 10 and 16 adverse events in treated patients, and 12 and 24 in controls at 6-month and 2-year follow-up, respectively. Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002). Intravenous autologous MSC treatment following stroke was safe and feasible. Motor performance and task-related MI activity results suggest that MSCs improve motor recovery through sensorimotor neuroplasticity. ClinicalTrials.gov Identifier NCT00875654.",2020,"Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002).","['Subacute Ischemic Stroke', 'primary motor cortex (MI', '31 enrolled patients, 16 patients received', 'subacute stroke', 'enrolled patients aged 18-70\xa0years less than 2\xa0weeks following moderate-severe ischemic carotid stroke']","['intravenous MSCs', 'intravenous autologous bone marrow-derived MSCs', 'Intravenous autologous MSC', 'MSCs', 'Autologous Mesenchymal Stem Cells']","['task-related fMRI activity in MI-4a', 'global and motor recovery', 'safety, feasibility, and efficacy', 'motor-NIHSS', 'feasibility and safety', 'motor-Fugl-Meyer scores', 'Passive wrist movement functional MRI (fMRI) activity', 'Barthel Index, NIHSS, and modified-Rankin scores']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C3888574', 'cui_str': 'Modified Rankin score'}]",31.0,0.338725,"Using mixed modeling analyses, we observed no treatment effects on the Barthel Index, NIHSS, and modified-Rankin scores, but significant improvements in motor-NIHSS (p = 0.004), motor-Fugl-Meyer scores (p = 0.028), and task-related fMRI activity in MI-4a (p = 0.031) and MI-4p (p = 0.002).","[{'ForeName': 'Assia', 'Initials': 'A', 'LastName': 'Jaillard', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France. Jaillard@univ-grenoble-alpes.fr.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hommel', 'Affiliation': 'AGEIS EA 7407, Université Grenoble Alpes (UGA), Grenoble, France.'}, {'ForeName': 'Anaick', 'Initials': 'A', 'LastName': 'Moisan', 'Affiliation': 'Cell Therapy and Engineering Unit, EFS Rhône Alpes Auvergne, Saint Ismier, France.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zeffiro', 'Affiliation': 'University of Maryland Medical Center, Baltimore, MD, USA.'}, {'ForeName': 'Isabelle M', 'Initials': 'IM', 'LastName': 'Favre-Wiki', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Barbieux-Guillot', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Vadot', 'Affiliation': 'Stroke Unit, CH Annecy-Genevois, Epagny Metz-Tessy, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Marcel', 'Affiliation': 'Stroke Unit, CH Métropole Savoie, Chambéry, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Lamalle', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Grand', 'Affiliation': 'IRMaGe, Inserm US17 CNRS UMS 3552-UGA, CHU Grenoble Alpes (CHUGA), Grenoble, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Detante', 'Affiliation': 'Stroke Unit, CHUGA, La Tronche, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational stroke research,['10.1007/s12975-020-00787-z']
1235,32461554,Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial.,"OBJECTIVE


Recent clinical trials have demonstrated that colchicine may have metabolic and cardiovascular and benefits in at-risk patients; however, the mechanisms through which colchicine may improve outcomes are still unclear. We sought to examine colchicine's effects on circulating inflammatory and metabolic molecules in adults with obesity and metabolic syndrome (MetS).
METHODS


Blood samples were collected pre- and post-intervention during a double-blind randomized controlled trial in which 40 adults with obesity and MetS were randomized to colchicine 0.6 mg or placebo twice-daily for 3 months. Serum samples were analyzed for 1305 circulating factors using the SomaScan Platform. The Benjamini-Hochberg procedure was used to adjust the false discovery rate (FDR) for multiple testing.
RESULTS


At baseline, age (48.0 ± 13.8 vs. 44.7 ± 10.3 years) and BMI (39.8 ± 6.4 vs. 41.8 ± 8.2 kg/m 2 ) were not different between groups. After controlling for the FDR, 34 molecules were significantly changed by colchicine. Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A). Conversely, relative to placebo, colchicine significantly increased concentrations of eight molecules including secreted factors associated with metabolism and anti-thrombosis.
CONCLUSIONS


In adults with obesity, colchicine significantly affected concentrations of proteins involved in the innate immune system, endothelial function and atherosclerosis, uncovering new mechanisms behind its cardiometabolic effects. Further research is warranted to investigate whether colchicine's IL-6 suppressive effects may be beneficial in COVID-19.",2020,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","['adults with obesity and metabolic syndrome', '40 adults with obesity and MetS', 'adults with obesity and metabolic syndrome (MetS', 'At baseline, age (48.0\u2009±\u200913.8 vs. 44.7\u2009±\u200910.3 years) and BMI (39.8\u2009±\u20096.4 vs. 41.8\u2009±\u20098.2\u2009kg/m 2 ']","['placebo, colchicine', 'Colchicine', 'colchicine', ""Colchicine's"", 'colchicine 0.6\u2009mg or placebo']","['concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin', 'metabolic and inflammatory molecules', 'circulating inflammatory and metabolic molecules', 'false discovery rate (FDR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0985108', 'cui_str': 'Colchicine 0.6 MG'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",40.0,0.602228,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA. ademido1@jh.edu.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Apps', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Foo K', 'Initials': 'FK', 'LastName': 'Cheung', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Jinguo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Fantoni', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Tushar P', 'Initials': 'TP', 'LastName': 'Patel', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0598-3']
1236,32468956,"Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study.","PURPOSE


Pembrolizumab monotherapy has shown antitumor activity in patients with small-cell lung cancer (SCLC). The randomized, double-blind, phase III KEYNOTE-604 study compared pembrolizumab plus etoposide and platinum (EP) with placebo plus EP for patients with previously untreated extensive-stage (ES) SCLC.
METHODS


Eligible patients were randomly assigned 1:1 to pembrolizumab 200 mg once every 3 weeks or saline placebo for up to 35 cycles plus 4 cycles of EP. Primary end points were progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS) in the intention-to-treat population. Objective response rate (ORR) and duration of response were secondary end points. Prespecified efficacy boundaries were one-sided  P  = .0048 for PFS and .0128 for OS.
RESULTS


Of the 453 participants, 228 were randomly assigned to pembrolizumab plus EP and 225 to placebo plus EP. Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023). Twelve-month PFS estimates were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. Although pembrolizumab plus EP prolonged OS, the significance threshold was not met (HR, 0.80; 95% CI, 0.64 to 0.98;  P  = .0164). Twenty-four-month OS estimates were 22.5% and 11.2%, respectively. ORR was 70.6% in the pembrolizumab plus EP group and 61.8% in the placebo plus EP group; the estimated proportion of responders remaining in response at 12 months was 19.3% and 3.3%, respectively. In the pembrolizumab plus EP and placebo plus EP groups, respectively, any-cause adverse events were grade 3-4 in 76.7% and 74.9%, grade 5 in 6.3% and 5.4%, and led to discontinuation of any drug in 14.8% and 6.3%.
CONCLUSION


Pembrolizumab plus EP significantly improved PFS compared with placebo plus EP as first-line therapy for patients with ES-SCLC. No unexpected toxicities were seen with pembrolizumab plus EP. These data support the benefit of pembrolizumab in ES-SCLC.",2020,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","['453 participants', 'patients with ES-SCLC', 'patients with small-cell lung cancer (SCLC', 'Extensive-Stage Small-Cell Lung Cancer', 'Eligible patients', 'patients with previously untreated extensive-stage (ES) SCLC']","['Pembrolizumab or Placebo Plus Etoposide and Platinum', 'pembrolizumab plus EP', 'placebo plus EP', 'Pembrolizumab plus EP', 'pembrolizumab 200 mg once every 3 weeks or saline placebo', 'pembrolizumab plus EP and placebo plus EP', 'Pembrolizumab monotherapy', 'pembrolizumab plus etoposide and platinum (EP) with placebo plus EP']","['PFS', 'Objective response rate (ORR) and duration of response', 'toxicities', 'ORR', 'progression-free survival (PFS; RECIST version 1.1, blinded central review) and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0149925', 'cui_str': 'Small cell carcinoma of lung'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",453.0,0.588583,"Pembrolizumab plus EP significantly improved PFS (hazard ratio [HR], 0.75; 95% CI, 0.61 to 0.91;  P  = .0023).","[{'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Rudin', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navarro', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Gottfried', 'Affiliation': 'Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Hetényi Géza Kórház Onkológiai Központ, Szolnok, Hungary.'}, {'ForeName': 'Parneet K', 'Initials': 'PK', 'LastName': 'Cheema', 'Affiliation': 'William Osler Health System, University of Toronto, Brampton, Ontario, Canada.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Wollner', 'Affiliation': 'Rambam Medical Center, Haifa, Israel.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Orlandi', 'Affiliation': 'Oncología-Health and Care, Santiago, Chile.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Istanbul Medeniyet University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Kalemkerian', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ebiana', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Kenilworth, NJ.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00793']
1237,32581088,Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.,"OBJECTIVES


Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.
METHODS


Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m 2 ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.
RESULTS


188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections.
CONCLUSIONS


This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.",2020,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","['Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis', 'patients with relapsing AAV treated with', 'patients enrolled into the induction phase of the RITAZAREM trial', '188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years', 'patients with AAV who have relapsed, with a similar safety profile to previous studies']","['cyclophosphamide', 'rituximab and glucocorticoids', 'Rituximab', 'remission-induction therapy with rituximab (4×375\u2009mg/m 2 ) and a higher or lower dose glucocorticoid regimen', 'rituximab in conjunction with glucocorticoids', 'rituximab']",['41 severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",188.0,0.0880274,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","[{'ForeName': 'Rona M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'University of Cambridge, Cambridge, UK ronasmith@doctors.net.uk.'}, {'ForeName': 'Rachel Bronwen', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Nodale', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Aljayyousi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Camilleri', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chee Kay', 'Initials': 'CK', 'LastName': 'Cheung', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Derebail', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Doulton', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Lindsy', 'Initials': 'L', 'LastName': 'Forbess', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Gewurz-Singer', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Klocke', 'Affiliation': 'Dudley Group NHS Foundation Trust, Dudley, West Midlands, UK.'}, {'ForeName': 'Curry', 'Initials': 'C', 'LastName': 'Koening', 'Affiliation': 'University of Utah Vasculitis Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Komagata', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Rheumatology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Raashid Ahmed', 'Initials': 'RA', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama Universty Hospital, Okayama, Japan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'McAlear', 'Affiliation': 'Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'Division of Rheumatology, VA Boston Healthcare System, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburg, Pittsburg, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mynard', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nachman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Rennie L', 'Initials': 'RL', 'LastName': 'Rhee', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'HSS, New York, New York, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wroe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, Middlesbrough, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216863']
1238,32581112,"A Genetic Risk Score to Personalize Prostate Cancer Screening, Applied to Population Data.","BACKGROUND


A polygenic hazard score (PHS), the weighted sum of 54 SNP genotypes, was previously validated for association with clinically significant prostate cancer and for improved prostate cancer screening accuracy. Here, we assess the potential impact of PHS-informed screening.
METHODS


United Kingdom population incidence data (Cancer Research United Kingdom) and data from the Cluster Randomized Trial of PSA Testing for Prostate Cancer were combined to estimate age-specific clinically significant prostate cancer incidence (Gleason score ≥7, stage T3-T4, PSA ≥10, or nodal/distant metastases). Using HRs estimated from the ProtecT prostate cancer trial, age-specific incidence rates were calculated for various PHS risk percentiles. Risk-equivalent age, when someone with a given PHS percentile has prostate cancer risk equivalent to an average 50-year-old man (50-year-standard risk), was derived from PHS and incidence data. Positive predictive value (PPV) of PSA testing for clinically significant prostate cancer was calculated using PHS-adjusted age groups.
RESULTS


The expected age at diagnosis of clinically significant prostate cancer differs by 19 years between the 1st and 99th PHS percentiles: men with PHS in the 1st and 99th percentiles reach the 50-year-standard risk level at ages 60 and 41, respectively. PPV of PSA was higher for men with higher PHS-adjusted age.
CONCLUSIONS


PHS provides individualized estimates of risk-equivalent age for clinically significant prostate cancer. Screening initiation could be adjusted by a man's PHS.
IMPACT


Personalized genetic risk assessments could inform prostate cancer screening decisions.",2020,"PPV of PSA was higher for men with higher PHS-adjusted age.
","['UK population incidence data (Cancer Research UK) and data from the Cluster Randomized Trial of PSA Testing for Prostate Cancer were combined to estimate age-specific clinically significant prostate cancer incidence (Gleason≥7, stage T3-T4, PSA ≥10, or nodal/distant metastases', 'men with higher PHS-adjusted age']",[],['PPV of PSA'],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0475374', 'cui_str': 'T3 category'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}]",,0.0430511,"PPV of PSA was higher for men with higher PHS-adjusted age.
","[{'ForeName': 'Minh-Phuong', 'Initials': 'MP', 'LastName': 'Huynh-Le', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Chun Chieh', 'Initials': 'CC', 'LastName': 'Fan', 'Affiliation': 'Center for Multimodal Imaging and Genetics, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Karunamuni', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, Department of Population Health Sciences, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, University of California, San Diego, La Jolla, California.'}, {'ForeName': 'Rosalind A', 'Initials': 'RA', 'LastName': 'Eeles', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Easton', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Zsofia', 'Initials': 'Z', 'LastName': 'Kote-Jarai', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Amin Al Olama', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Benlloch Garcia', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Public Health and Primary Care, University of Cambridge, Strangeways Research Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Muir', 'Affiliation': 'Division of Population Health, Health Services Research and Primary Care, University of Manchester, Oxford Road, Manchester, United Kingdom.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Grönberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Wiklund', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Aly', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schleutker', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Sipeky', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Teuvo Lj', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Faculty of Medicine and Health Technology, Prostate Cancer Research Center, Tampere University, Tampere, Finland.'}, {'ForeName': 'Børge Grønne', 'Initials': 'BG', 'LastName': 'Nordestgaard', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Key', 'Affiliation': 'University of Oxford, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ruth C', 'Initials': 'RC', 'LastName': 'Travis', 'Affiliation': 'University of Oxford, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul D P', 'Initials': 'PDP', 'LastName': 'Pharoah', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Oncology, University of Cambridge, Strangeways Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Pashayan', 'Affiliation': 'Centre for Cancer Genetic Epidemiology, Department of Oncology, University of Cambridge, Strangeways Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Kay-Tee', 'Initials': 'KT', 'LastName': 'Khaw', 'Affiliation': 'Clinical Gerontology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Thibodeau', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Shannon K', 'Initials': 'SK', 'LastName': 'McDonnell', 'Affiliation': 'Division of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Schaid', 'Affiliation': 'Division of Biomedical Statistics & Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Maier', 'Affiliation': 'Humangenetik Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Walther', 'Initials': 'W', 'LastName': 'Vogel', 'Affiliation': 'Institute for Human Genetics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Luedeke', 'Affiliation': 'Humangenetik Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Herkommer', 'Affiliation': 'Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Urology, Munich, Germany.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': 'Division of Urologic Surgery, Brigham and Womens Hospital, Boston, Massachusetts.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Cybulski', 'Affiliation': 'International Hereditary Cancer Center, Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Wokolorczyk', 'Affiliation': 'International Hereditary Cancer Center, Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kluzniak', 'Affiliation': 'International Hereditary Cancer Center, Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cannon-Albright', 'Affiliation': 'Division of Genetic Epidemiology, Department of Medicine, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brenner', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Schöttker', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Holleczek', 'Affiliation': 'Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Jong Y', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Sellers', 'Affiliation': 'Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Hui-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'School of Public Health, Louisiana State University Health Sciences Center, New Orleans, Louisiana.'}, {'ForeName': 'Chavdar Kroumov', 'Initials': 'CK', 'LastName': 'Slavov', 'Affiliation': 'Department of Urology and Alexandrovska University Hospital, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Radka P', 'Initials': 'RP', 'LastName': 'Kaneva', 'Affiliation': 'Molecular Medicine Center, Department of Medical Chemistry and Biochemistry, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Vanio I', 'Initials': 'VI', 'LastName': 'Mitev', 'Affiliation': 'Molecular Medicine Center, Department of Medical Chemistry and Biochemistry, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Batra', 'Affiliation': 'Institute of Health and Biomedical Innovation and School of Biomedical Sciences, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Clements', 'Affiliation': 'Australian Prostate Cancer Research @Centre-Qld, Translational Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Spurdle', 'Affiliation': ''}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Teixeira', 'Affiliation': 'Department of Genetics, Portuguese Oncology Institute, Porto, Portugal.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Paulo', 'Affiliation': 'Department of Genetics, Portuguese Oncology Institute, Porto, Portugal.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Maia', 'Affiliation': 'Department of Genetics, Portuguese Oncology Institute, Porto, Portugal.'}, {'ForeName': 'Hardev', 'Initials': 'H', 'LastName': 'Pandha', 'Affiliation': 'The University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Michael', 'Affiliation': 'The University of Surrey, Guildford, Surrey, United Kingdom.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Mills', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anders M', 'Initials': 'AM', 'LastName': 'Dale', 'Affiliation': 'Center for Multimodal Imaging and Genetics, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Seibert', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1527']
1239,32585278,"Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study.","BACKGROUND


Onychomycosis is a recalcitrant fungal nail infection. Topical antifungal agents may be preferred over systemic agents due to lack of systemic adverse effects.
OBJECTIVE


To investigate the efficacy and safety of topical terbinafine 10% solution (MOB-015) for the treatment of distal and lateral subungual onychomycosis.
METHODS


In a multicenter, double-blind, phase III, North American study, patients with mild to moderate distal and lateral subungual onychomycosis involving 20% to 60% of at least 1 great toenail were randomized to once daily application of MOB-015 or matching vehicle for 48 weeks. The primary efficacy variable was complete cure, while the secondary efficacy variables were mycological cure and treatment success. Safety evaluations were also performed.
RESULTS


At week 52, the mycological cure (negative culture and potassium hydroxide microscopy) rate in the MOB-015 and vehicle groups was 69.9% and 27.7%, respectively (P < .001), and complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% of patients, respectively (P = .0195). At least 1 adverse event leading to discontinuation of treatment occurred in 2.8% of patients in the MOB-015 group and in 4.2% in the vehicle group.
LIMITATION


The follow-up period after end of treatment may not be sufficient to accurately reflect cure in distal and lateral subungual onychomycosis.
CONCLUSIONS


MOB-015 is a treatment option for onychomycosis with an adverse event profile similar to vehicle.",2020,"Complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% subjects, respectively (P=0.0195).","['North American study subjects with mild to moderate DSO involving 20-60% of at least one great toenail', 'distal and lateral subungual onychomycosis (DSO', 'mild-to-moderate distal subungual onychomycosis']","['MOB-015 or matching vehicle', 'topical terbinafine 10% solution (MOB-015']","['adverse event (AE) leading to discontinuation', 'Efficacy and safety', 'complete and mycological cure', 'efficacy and safety', 'mycological cure (negative culture and KOH) rate', 'Complete cure', 'mycological cure']","[{'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1274513', 'cui_str': 'Distal and lateral subungual onychomycosis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}]","[{'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}]",,0.185955,"Complete cure (0% clinical disease involvement and mycological cure) was achieved in 4.5% and 0% subjects, respectively (P=0.0195).","[{'ForeName': 'Aditya K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Mediprobe Research Inc, London, Ontario, Canada. Electronic address: agupta@execulink.com.'}, {'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Surprenant', 'Affiliation': 'Doctors Research Network, Miami, Florida.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kempers', 'Affiliation': 'Minnesota Clinical Study Center, Fridley, Minnesota.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Department of Dermatology, Eastern Virginia Medical School and Virginia Clinical Research, Inc, Norfolk, Virginia.'}, {'ForeName': 'Kjell', 'Initials': 'K', 'LastName': 'Rensfeldt', 'Affiliation': 'currently retired, Stockholm, Sweden.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Tavakkol', 'Affiliation': 'Moberg Pharma AB (publ), Bromma, Sweden. Electronic address: amir.tavakkol@mobergpharma.se.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.055']
1240,32448931,The disaster worker resiliency training program: a randomized clinical trial.,"OBJECTIVES


Disaster workers are at elevated risk for mental health problems as a result of trauma exposures during response efforts. One possible way to prevent mental health problems is to build-up coping resources that promote resilience to the effects of disaster work. The primary aim of this study was to evaluate the efficacy of a resilience building workshop, the Disaster Worker Resiliency Training Program (DWRT), in disaster workers previously exposed to Hurricane Sandy.
METHODS


Disaster workers (N = 167) were randomly assigned to the DWRT workshop (n = 78) or a waitlist (n = 89). Workers completed self-report measures on healthy lifestyle behaviors, perceived stress, depression, and Posttraumatic Stress Disorder (PTSD) symptoms at baseline and 3-month follow-up. They also completed a measure assessing subsequent trauma-exposure between the baseline and 3-month post-intervention.
RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02). Among participants reporting subsequent trauma exposures between T1 and T2  (n = 101), participants in the waitlist condition, were more likely to report significant increases in perceived stress (η 2  = .07, p < .01), PTSD (η 2  = .05, p = .03), and depression (η 2  = .07, p < .01) symptoms.
CONCLUSIONS


Participation in the resilience workshop promoted engagement in positive health behaviors and reduced the incidence of mental health symptoms, especially when administered prior to a repeat trauma exposure. Further research is needed to evaluate the long-term health effects of participation in the program.",2020,"RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02).","['Disaster workers (N\u2009=\u2009167', 'disaster workers previously exposed to Hurricane Sandy']","['DWRT workshop', 'resilience building workshop, the Disaster Worker Resiliency Training Program (DWRT']","['incidence of mental health symptoms', 'healthy lifestyle behaviors', 'stress management', 'positive health behaviors', 'spiritual growth', 'PTSD', 'healthy lifestyle behaviors, perceived stress, depression, and Posttraumatic Stress Disorder (PTSD) symptoms', 'depression', 'perceived stress']","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020183', 'cui_str': 'Hurricane'}]","[{'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687002', 'cui_str': 'Spiritual growth'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",167.0,0.0234846,"RESULTS


Participants in the workshop condition, as compared to those in a waitlist control, reported significantly greater improvements from pre-intervention (T1) to 3-month follow-up (T2) in healthy lifestyle behaviors (η 2  = .03; p = .03), stress management (η 2  = .03, p = .04), and spiritual growth (η 2  = .03, p = .02).","[{'ForeName': 'Brittain L', 'Initials': 'BL', 'LastName': 'Mahaffey', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Stony Brook University School of Medicine, Putnam Hall-South Campus, Stony Brook, NY, 11794, USA. Brittain.Mahaffey@stonybrookmedicine.edu.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Mackin', 'Affiliation': 'Department of Psychology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosen', 'Affiliation': 'National Clearinghouse for Worker Safety & Health Training, Washington, DC, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Schwartz', 'Affiliation': 'Center for Disaster Health Trauma, & Resilience at Stony Brook University, Mount Sinai, and Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Taioli', 'Affiliation': 'Center for Disaster Health Trauma, & Resilience at Stony Brook University, Mount Sinai, and Northwell Health, Great Neck, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Stony Brook University School of Medicine, Putnam Hall-South Campus, Stony Brook, NY, 11794, USA.'}]",International archives of occupational and environmental health,['10.1007/s00420-020-01552-3']
1241,32453346,"Effects of a Workplace Wellness Program on Employee Health, Health Beliefs, and Medical Use: A Randomized Clinical Trial.","Importance


Many employers use workplace wellness programs to improve employee health and reduce medical costs, but randomized evaluations of their efficacy are rare.
Objective


To evaluate the effect of a comprehensive workplace wellness program on employee health, health beliefs, and medical use after 12 and 24 months.
Design, Setting, and Participants


This randomized clinical trial of 4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018. Members of the treatment group (n = 3300) received incentives to participate in the workplace wellness program. Members of the control group (n = 1534) did not participate in the wellness program. Statistical analysis was performed on April 9, 2020.
Interventions


The 2-year workplace wellness program included financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management).
Main Outcomes and Measures


Measures taken at 12 and 24 months included clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes).
Results


Among the 4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years), no significant effects of the program on biometrics, medical diagnoses, or medical use were seen after 12 or 24 months. A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002). The intervention significantly improved a set of employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly decreased by 0.07 SDs (95% CI, -0.12 to -0.01 SDs; P = .02); however, effects on individual belief measures were not significant.
Conclusions and Relevance


This randomized clinical trial showed that a comprehensive workplace wellness program had no significant effects on measured physical health outcomes, rates of medical diagnoses, or the use of health care services after 24 months, but it increased the proportion of employees reporting that they have a primary care physician and improved employee beliefs about their own health.
Trial Registration


American Economic Association Randomized Controlled Trial Registry number: AEARCTR-0001368.",2020,A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002).,"['4834 participants (2770 women; mean [SD] age, 43.9 [11.3] years', '4834 employees of the University of Illinois at Urbana-Champaign was conducted from August 9, 2016, to April 26, 2018']","['incentives to participate in the workplace wellness program', 'Workplace Wellness Program', 'comprehensive workplace wellness program']","['physical health outcomes, rates of medical diagnoses, or the use of health care services', 'employee health beliefs on average: participant beliefs about their chance of having a body mass index greater than 30, high cholesterol, high blood pressure, and impaired glucose level jointly', 'proportion of employees', 'biometrics, medical diagnoses, or medical use', 'employee health, health beliefs, and medical use', 'Employee Health, Health Beliefs, and Medical Use', 'clinician-collected biometrics (16 outcomes), administrative claims related to medical diagnoses (diabetes, hypertension, and hyperlipidemia) and medical use (office visits, inpatient visits, and emergency department visits), and self-reported health behaviors and health beliefs (14 outcomes', 'financial incentives and paid time off for annual on-site biometric screenings, annual health risk assessments, and ongoing wellness activities (eg, physical activity, smoking cessation, and disease management']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0079272', 'cui_str': 'Employee Health'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0679809', 'cui_str': 'Health Risk Assessment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",4834.0,0.0185591,A significantly higher proportion of employees in the treatment group than in the control group reported having a primary care physician after 24 months (1106 of 1200 [92.2%] vs 477 of 554 [86.1%]; adjusted P = .002).,"[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Reif', 'Affiliation': 'Department of Finance, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'National Bureau of Economic Research, Cambridge, Massachusetts.'}, {'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'National Bureau of Economic Research, Cambridge, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Payne', 'Affiliation': 'Department of Recreation, Sport and Tourism, University of Illinois at Urbana-Champaign.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Molitor', 'Affiliation': 'Department of Finance, University of Illinois at Urbana-Champaign.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1321']
1242,32453667,Biomechanical Functional Elbow Restoration of Acute Ulnar Collateral Ligament Tears: The Role of Internal Bracing on Gap Formation and Repair Stabilization.,"BACKGROUND


Biomechanical studies have compared augmented primary repair with internal bracing versus reconstruction techniques of the anterior ulnar collateral ligament (aUCL) in the elbow. However, aUCL repair alone has not been compared with augmented repair or reconstruction techniques.
HYPOTHESIS


Internal bracing of aUCL repair provides improved time-zero stabilization in terms of gap formation, torsional stiffness, and residual torque compared with both repair alone and the modified docking technique, with enhanced valgus stability restoration to that of the native ligament.
STUDY DESIGN


Controlled laboratory study.
METHODS


We randomized 8 matched pairs of cadaveric elbows to undergo either augmented aUCL repair or a modified docking technique through use of the palmaris longus tendon. Valgus laxity testing was consecutively performed at 90° of flexion on the intact, torn, and repaired conditions as well as the previously assigned techniques. First, intact elbows were loaded up to 10 N·m valgus torque to evaluate time-zero ligament rotations at valgus moments of 2.5, 5.0, 7.5, and 10 N·m. Rotation controlled cycling was performed (total 1000 cycles) for each surgical condition. Gap formation, stiffness, and residual torque were analyzed. Finally, these elbows and 8 additional intact elbows underwent torque to failure testing (30 deg/min).
RESULTS


Repair alone revealed low torsional resistance and gapping, similar to the torn state. The augmented repair technique showed significantly higher torsional stiffness ( P  < .001) and residual torque ( P  < .001) compared with all other conditions and restored native function. Although reconstruction revealed similar initial stiffness and residual torque compared with an intact ligament, a steady decrease of torsional resistance led to a completely loose state at higher valgus rotations. Analysis of covariance between all groups showed significantly less gap formation for augmented repair ( P  < .001). The native failure load and stiffness were significantly higher and were similar to those of augmented repair ( P  = .766).
CONCLUSION


Internal bracing of aUCL repair restored valgus stability to the native state with statistically improved torsional resistance, loading capability, and gap formation compared with reconstruction, especially at the upper load range of native aUCL function in the elbow.
CLINICAL RELEVANCE


We found that aUCL repair with an internal brace effectively improves time-zero mechanical characteristics and may provide stabilized healing with accelerated and reliable recovery without the need for a tendon graft.",2020,The augmented repair technique showed significantly higher torsional stiffness ( P  < .001) and residual torque ( P  < .001) compared with all other conditions and restored native function.,['Acute Ulnar Collateral Ligament Tears'],"['cadaveric elbows to undergo either augmented aUCL repair or a modified docking technique through use of the palmaris longus tendon', 'primary repair with internal bracing versus reconstruction techniques of the anterior ulnar collateral ligament (aUCL']","['torsional stiffness', 'low torsional resistance', 'time-zero mechanical characteristics', 'native failure load and stiffness', 'Biomechanical Functional Elbow Restoration', 'residual torque', 'torsional resistance', 'torsional resistance, loading capability, and gap formation', 'initial stiffness and residual torque', 'Gap formation, stiffness, and residual torque']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1261052', 'cui_str': 'Structure of collateral carpal ulnar ligament'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1261052', 'cui_str': 'Structure of collateral carpal ulnar ligament'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442632', 'cui_str': 'Dock - marine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0448547', 'cui_str': 'Structure of tendon of palmaris longus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",8.0,0.0337054,The augmented repair technique showed significantly higher torsional stiffness ( P  < .001) and residual torque ( P  < .001) compared with all other conditions and restored native function.,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bachmaier', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Coen A', 'Initials': 'CA', 'LastName': 'Wijdicks', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Laurence D', 'Initials': 'LD', 'LastName': 'Higgins', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Greiner', 'Affiliation': 'Sporthopaedicum, Regensburg, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520921174']
1243,32463430,Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial.,"Importance


Adenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age.
Objective


To determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA.
Design, Setting, and Participants


This randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.
Interventions


Adenotonsillectomy.
Main Outcomes and Measures


The primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses. Polysomnography and the OSA-18 questionnaire were completed at baseline and after 6 months.
Results


Of the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA-18 questionnaire (eg, total OSA-18 score: -17; 95% CI, -24 to -10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and <10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (-3.1; 95% CI, -5.7 to -0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline.
Conclusions and Relevance


This randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.
Trial Registration


ClinicalTrials.gov Identifier: NCT02315911.",2020,"Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE.","['With Mild to Moderate Obstructive Sleep Apnea', 'children between 2 and 4 years of age', '60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n\u2009=\u200929) or', 'healthy children with mild to moderate OSA.\nDesign, Setting, and Participants', 'A total of 53 participants (88%; ATE, n\u2009=\u200925; watchful waiting, n\u2009=\u200928) completed the study', '60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months', 'December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden', 'Young Children', 'Data were analyzed from August 2018 to December 2018', 'children with obstructive sleep apnea (OSA']","['Adenotonsillectomy vs Watchful Waiting', 'Adenotonsillectomy (ATE', 'ATE', 'watchful waiting']","['quality of life', 'polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses', 'mean OAHI score change', 'mean OAHI score', 'Polysomnography and the OSA-18 questionnaire', 'OSA-18 questionnaire']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0587514', 'cui_str': 'Ear, nose and throat department'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",24.0,0.10545,"Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE.","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fehrm', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nerfeldt', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Browaldh', 'Affiliation': 'Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2020.0869']
1244,32463456,Effect of Osimertinib and Bevacizumab on Progression-Free Survival for Patients With Metastatic EGFR-Mutant Lung Cancers: A Phase 1/2 Single-Group Open-Label Trial.,"Importance


The combination of erlotinib and bevacizumab as initial treatment of epidermal growth factor receptor (EGFR [OMIM 131550])-mutant lung cancers improves progression-free survival (PFS) compared with erlotinib alone. Because osimertinib prolongs PFS compared with erlotinib, this trial was designed to study the combination of osimertinib and bevacizumab as first-line treatment.
Objectives


To determine the safety and tolerability of osimertinib and bevacizumab combination treatment and assess the 12-month PFS of the combination in patients with metastatic EGFR-mutant lung cancers.
Design, Setting, and Particiants


From August 15, 2016, to May 15, 2018, 49 patients with metastatic EGFR-mutant lung cancers were enrolled in this interventional clinical trial, conducted at a single academic cancer center. In the phase 1 portion of the study, a standard 3 + 3 dose de-escalation design was used to determine the maximum tolerated dose of osimertinib and bevacizumab. In the phase 2 portion of the study, patients were treated at the maximum tolerated dose defined in the phase 1 portion. Statistical analysis was performed from August 1 to October 1, 2019.
Interventions


All patients received osimertinib, 80 mg daily, and bevacizumab, 15 mg/kg once every 3 weeks.
Main Outcomes and Measures


The primary objective of the phase 2 portion of the study was to determine the number of patients receiving the combination of osimertinib and bevacizumab who were progression free at 12 months. Secondary end points included overall response rate, median PFS, overall survival, and definition of the toxic effects of the combination treatment.
Results


Among the 49 patients in the study (34 women; median age, 60 years [range, 36-83 years]), PFS at 12 months was 76% (95% CI, 65%-90%). The overall response rate was 80% (95% CI, 67%-91%), and median PFS was 19 months (95% CI, 15-24 months). Of the 6 patients with measurable central nervous system disease, all had a partial or complete central nervous system response. Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002). Identified mechanisms of resistance included squamous cell transformation (n = 2) pleomorphic transformation (n = 1), and acquired EGFR L718Q (n = 1) and C797S (n = 1) mutations.
Conclusions and Relevance


The combination of osimertinib and bevacizumab met the study's prespecified effectiveness end point. Persistent EGFR-mutant circulating tumor DNA at 6 weeks was associated with early progression and shorter survival. A randomized phase 3 study comparing osimertinib and bevacizumab with osimertinib alone is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT02803203.",2020,"Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002).","['patients with metastatic EGFR-mutant lung cancers', '6 patients with measurable central nervous system disease, all had a partial or complete central nervous system response', '49 patients in the study (34 women; median age, 60 years [range, 36-83 years', '49 patients with metastatic EGFR-mutant lung cancers', 'Patients With Metastatic EGFR-Mutant Lung Cancers']","['Osimertinib and Bevacizumab', 'erlotinib and bevacizumab', 'osimertinib and bevacizumab', 'bevacizumab']","['early progression and shorter survival', 'overall response rate, median PFS, overall survival, and definition of the toxic effects of the combination treatment', 'safety and tolerability', 'median overall survival (clearance', 'median PFS (clearance', 'overall response rate', 'Progression-Free Survival', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",49.0,0.125856,"Persistent detection of EGFR-mutant circulating tumor (ct)DNA at 6 weeks was associated with shorter median PFS (clearance at 6 weeks, 16.2 months [95% CI, 13 months to not reached]; and no clearance at 6 weeks, 9.8 months [95% CI, 4 months to not reached]; P = .04) and median overall survival (clearance at 6 weeks, not reached; and no clearance at 6 weeks, 10.1 months [95% CI, 6 months to not reached]; P = .002).","[{'ForeName': 'Helena A', 'Initials': 'HA', 'LastName': 'Yu', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Schoenfeld', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Makhnin', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kim', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Rizvi', 'Affiliation': 'Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tsui', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Falcon', 'Affiliation': 'Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Houck-Loomis', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Fanli', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Julie Li', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Tobi', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Heller', 'Affiliation': 'Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Ahn', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hayes', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Young', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Arcila', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berger', 'Affiliation': 'Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Chaft', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ladanyi', 'Affiliation': 'Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Riely', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kris', 'Affiliation': 'Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1260']
1245,32460414,The effects of home noninvasive ventilation on the quality of life and physiological parameters of patients with chronic respiratory failure.,"INTRODUCTION


Home noninvasive mechanical ventilation (HNIV) in patients with chronic hypercapnic respiratory failure (CHRF) may improve the health-related quality of life (HRQoL) and reduce hospitalizations.
OBJECTIVE


To determine the effects of HNIV on HRQoL, sleep quality and hospitalization rates in restrictive thoracic diseases (RTD) and chronic obstructive pulmonary disease (COPD) patients with CHRF.
METHODS


In this prospective, single center study patients divided into two groups; the COPD and the RTD groups. HRQoL assessed by The Medical Outcome Study 36-Item Short-form Health Survey (SF-36) and Severe Respiratory Insufficiency (SRI); the sleep quality was assessed by Epworth and Pittsburgh Sleep Quality Index questionnaires. The patients were reevaluated first month, third months, sixth months and 1 year following HNIV establishment, during which time, hospitalization rates were recorded.
RESULTS


Ninety (COPD n = 50, RTD n = 40) out of 102 eligible patients completed the study. Significant improvements in blood gases and HRQoL were observed in the first month of HNIV establishment and remained stable. Mean ± SD SRI summary scale improved significantly from 30 ± 12 baseline to 65 ± 16 at 1 year in COPD group (P < 0.001) and from 39 ± 13 to 63 ± 18 in RTD group (P < 0.001). HNIV reduced hospitalization rates from a mean of 1.9 ± 1.1 to 0.5 ± 0.9 in COPD group (P < 0.001) and a mean of 1.9 ± 1 to 0.5 ± 0.7 in RTD group (P < 0.001).
CONCLUSION


HNIV improves HRQoL, sleep quality and gas exchange and reduces hospitalizations in patients with CHRF regardless of etiology.",2020,Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001).,"['patients with CHRF regardless of etiology', 'COPD n=50, RTD n=40) out of 102 eligible patients completed the study', 'restrictive thoracic diseases (RTD) and COPD patients with CHRF', 'patients with chronic hypercapnic respiratory failure (CHRF', 'Ninety', 'Patients with Chronic Respiratory Failure']","['Home Noninvasive Ventilation', 'Home noninvasive mechanical ventilation (HNIV', 'HNIV']","['blood gases and HRQL', 'Epworth and Pitsburg Sleep Quality Index (PSQI) questionnaires', 'Quality Of Life and Physiological Parameters', 'Mean±SD SRI summary scale', 'hospitalization rates', 'HRQL assessed by The Medical Outcome Study 36-Item Short-form Health Survey (SF-36) and Severe Respiratory Insufficiency (SRI); the sleep quality', 'HRQoL, sleep quality and gas exchange and reduces hospitalizations', 'HRQL, sleep quality and hospitalization rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960052', 'cui_str': 'Chronic hypercapnic respiratory failure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0039978', 'cui_str': 'Disorder of thorax'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1868982', 'cui_str': 'Noninvasive mechanical ventilation'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034088', 'cui_str': 'Pulmonic valve regurgitation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",102.0,0.0463646,Mean±SD SRI summary scale improved significantly from 30±12 baseline to 65±16 at one year in COPD group (p<0.001) and from 39±13 to 63±18 in RTD group (p<0.001).,"[{'ForeName': 'Aycan', 'Initials': 'A', 'LastName': 'Yüksel', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Çiftçi', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Çiledağ', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Akın', 'Initials': 'A', 'LastName': 'Kaya', 'Affiliation': 'Faculty of Medicine, Department of Chest Diseases, Ankara University, Ankara, Turkey.'}]",The clinical respiratory journal,['10.1111/crj.13221']
1246,32461117,The value of extensive catheter linear ablation on persistent atrial fibrillation (the CLEAR-AF Study).,"BACKGROUND


The ablation therapy for persistent atrial fibrillation (PerAF) is still a challenge due to the high recurrence rate. This study was aimed to investigate the value of extensive linear ablation with contact force sensing techniques for PerAF.
METHODS


A total of 214 patients with PerAF were enrolled in five centers. The patients were randomly assigned to Group I (PVI + LA roof line+ LA anterior wall line) and Group II (PVI + LA roof line), mitral valve isthmus lines were added in both groups if the atrial fibrillation (AF) could not be terminated after all approaches above.
RESULTS


Acute success rate of AF termination during the ablation procedure in Group I was significantly higher than Group II (P = 0.028). Two-years follow-up showed no significant difference in the sinus rhythm maintenance rate between the two groups (63.4% in group I vs. 57.2% in group II, P = 0.218). More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P = 0.001). The Kaplan-Meier estimates of AF/AT-free survival after repeat ablation procedures were 76.2% in Group I and 47.1% in Group II (P = 0.039).
CONCLUSIONS


Extensive linear ablation with contact force monitoring did not improve the long-term outcomes for PerAF patients. Repeat ablation procedure showed a possible higher chance of sinus rhythm restoration during follow-up.",2020,"More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001).","['PerAF patients', '214 patients with PerAF were enrolled in five centers']","['Group I (PVI + LA roof line+ LA anterior wall line) and Group II (PVI + LA roof line), mitral valve isthmus lines', 'extensive catheter linear ablation']","['sinus rhythm restoration', 'sinus rhythm maintenance rate', 'organized atrial tachycardia (AT', 'AF termination']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0557685', 'cui_str': 'Roof'}, {'cui': 'C0442070', 'cui_str': 'Anterior wall'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0229583', 'cui_str': 'Structure of isthmus of thyroid gland'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",214.0,0.015255,"More patients in Group I recurred as organized atrial tachycardia (AT) and can be precisely mapped during repeat ablation procedures (15 vs. 2, P=0.001).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: ianyao@263.net.cn.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhongpeng', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Beijing Hospital, Beijing, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Wuhan Asia Heart Hospital, Wuhan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yuhe', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Erpeng', 'Initials': 'E', 'LastName': 'Liang', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingmin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.05.032']
1247,32468174,Hysterectomy with uterosacral suspension or Uphold™ hysteropexy in women with apical prolapse: a parallel cohort study.,"INTRODUCTION AND HYPOTHESIS


The aim was to compare objective and subjective cure rates between Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension.
METHODS


A sample size of 49 in each arm would be required to detect a clinical difference of 20% between the groups. Owing to delayed recruitment, this originally planned randomised controlled trial was changed to a patient preference study after randomising initial 6 participants. Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included. Routine follow-up was scheduled at 6 weeks, 6 months, 12 months, and annually thereafter. Primary outcome was absence of stage ≥2 apical prolapse. Secondary outcomes included a composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes were based on quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score).
RESULTS


We recruited 50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016. Participants were followed up for a median of 25 months (23-96). Five women from the VH (10%) and 7 from the HP (14%) group were lost to follow-up. Combined anatomical and symptomatic outcomes were available for 41 (82%) VH and 39 (76%) in the HP group. There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50). We found no difference in the composite cure rate (78% VH vs 85% HP, 0.45) between the groups. There was no significant difference in surgical complications (p = 0.33), assessed using Clavien-Dindo classification. There was a 2% surgery rate for mesh exposure in the HP group.
CONCLUSIONS


Uphold™ uterine suspension and VH appear to have similar objective and subjective cure at 25 months, with no significant difference in surgical complications.",2020,There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50).,"['patient preference study after randomising initial 6 participants', 'Women with symptomatic stage ≥2 uterine descent wishing a surgical solution were included', '50 patients undergoing VH between 2011 and 2013 and 51 patients undergoing HP between 2011 and 2016', 'women with apical prolapse']","['Uphold™ hysteropexy (HP) and vaginal hysterectomy (VH) with uterosacral suspension', 'Hysterectomy with uterosacral suspension or Uphold™ hysteropexy']","['composite cure of no leading edge beyond the hymen, absence of bulge symptoms and no retreatment; patient-reported outcomes', 'objective apical outcomes; the incidence of stage 2 prolapse', 'quality-of-life questionnaires (PFDI-20, PFIQ-7, PISQ-12, PGI-I, EQ5D and a health score', 'absence of stage ≥2 apical prolapse', 'objective and subjective cure', 'objective and subjective cure rates', 'composite cure rate', 'surgical complications']","[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]","[{'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0020700', 'cui_str': 'Vaginal hysterectomy'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.187724,There was no difference in objective apical outcomes; the incidence of stage 2 prolapse was 0% in the VH group and 2% in HP group (p = 0.50).,"[{'ForeName': 'Mugdha', 'Initials': 'M', 'LastName': 'Kulkarni', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia. doc.mugdha@gmail.com.'}, {'ForeName': 'Natharnia', 'Initials': 'N', 'LastName': 'Young', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'St. Vincents Clinic, UNSW Sydney Australia, Sydney, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosamilia', 'Affiliation': 'Monash Health, 823-865 Centre RRoad, Melbourne, 3165, Australia.'}]",International urogynecology journal,['10.1007/s00192-020-04328-y']
1248,32469106,Addressing social stressors in a brief motivational interview improve mental health symptoms for Latinx heavy drinkers.,"OBJECTIVE


Depressive and anxiety symptoms co-occur with hazardous drinking among Latinxs. This secondary analysis of a clinical trial to reduce hazardous drinking (motivational interviewing adapted to address social stressors [CAMI] vs. motivational interviewing [MI]) examined effects on anxiety/depressive symptoms. Discrimination and acculturation were examined as moderators.
METHODS


Latinx (n = 296) hazardous drinkers (2+ occasions/month of heavy drinking; 4/5 drinks/occasion, females/males) were randomized to CAMI/MI. Generalized estimating equations analyzed how treatment conditions and interactions were related to depressive and anxiety symptoms after controlling for covariates.
RESULTS


Baseline symptoms (anxiety, depression) exceeded clinical thresholds (Anxiety ≥8, M = 14.62, SD = 13.52; Depression ≥ 12, M = 18.78, SD = 12.57). Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI. CAMI with high baseline discrimination reported significantly less depression than MI (12 months).
CONCLUSIONS


Explicitly addressing social stressors may be a beneficial adjunct to treatment for Latinx drinkers.",2020,"Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI.","['Latinx heavy drinkers', 'Latinx drinkers', 'Latinx (n\u2009', '296) hazardous drinkers (2+ occasions/month of heavy drinking; 4/5 drinks/occasion, females/males', 'Depressive and anxiety symptoms co-occur with hazardous drinking among Latinxs']","['Cultural adaptation of motivational interviewing (CAMI', 'hazardous drinking (motivational interviewing adapted to address social stressors [CAMI] vs. motivational interviewing [MI', 'CAMI/MI']","['anxiety and depressive symptoms', 'depressive and anxiety symptoms', 'anxiety/depressive symptoms', 'mental health symptoms', 'Baseline symptoms (anxiety, depression) exceeded clinical thresholds ']","[{'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.0149421,"Cultural adaptation of motivational interviewing (CAMI) showed significantly lower anxiety and depressive symptoms (6/12 months, respectively) than MI.","[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Practice, Boston University School of Social Work, Boston, Massachusetts.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rosales', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Koriann', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Department of Applied Psychology, Northeastern University, Boston, Massachusetts.'}, {'ForeName': 'Damaris J', 'Initials': 'DJ', 'LastName': 'Rohsenow', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.'}]",Journal of clinical psychology,['10.1002/jclp.22976']
1249,32469385,Survival Outcomes Associated With 3 Years vs 1 Year of Adjuvant Imatinib for Patients With High-Risk Gastrointestinal Stromal Tumors: An Analysis of a Randomized Clinical Trial After 10-Year Follow-up.,"Importance


Adjuvant imatinib is associated with improved recurrence-free survival (RFS) when administered after surgery to patients with operable gastrointestinal stromal tumor (GIST), but its influence on overall survival (OS) has remained uncertain.
Objective


To evaluate the effect of adjuvant imatinib on OS of patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery.
Design, Setting, and Participants


In this open-label, randomized (1:1), multicenter phase 3 clinical trial conducted in Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008. Data for this follow-up analysis were analyzed from September to November, 2019.
Interventions


Imatinib 400 mg/d administered orally for either 12 months or 36 months after surgery.
Main Outcomes And Measures


The primary end point was RFS; the secondary objectives included OS and treatment safety.
Results


The intention-to-treat cohort consisted of 397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat population. Five-year and 10-year RFS was 71.4% and 52.5%, respectively, in the 36-month group and 53.0% and 41.8% in the 12-month group (hazard ratio [HR], 0.66; 95% CI, 0.49-0.87; P = .003). In the 36-month group, 5-year OS and 10-year OS rates were 92.0% and 79.0%, respectively, and in the 12-month group 85.5% and 65.3% (HR, 0.55; 95% CI, 0.37-0.83; P = .004). The results were similar in the efficacy population, from which 15 patients who did not have GIST in central pathology review and 24 patients who had intra-abdominal metastases removed at surgery were excluded (36-month group, 10-year OS 81.6%; 12-month group, 66.8%; HR, 0.50; 95% CI, 0.32-0.80; P = .003). No new safety signals were detected.
Conclusions and Relevance


Three years of adjuvant imatinib is superior in efficacy compared with 1 year of imatinib. Approximately 50% of deaths may be avoided during the first 10 years of follow-up after surgery with longer adjuvant imatinib treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT00116935.",2020,"No new safety signals were detected.
","['Finland, Germany, Norway, and Sweden, 400 patients who had undergone macroscopically complete surgery for GIST with a high estimated risk for recurrence according to the modified National Institutes of Health Consensus Criteria were enrolled between February 2004 and September 2008', 'patients with operable gastrointestinal stromal tumor (GIST', 'Patients With High-Risk Gastrointestinal Stromal Tumors', 'patients who have a high estimated risk for GIST recurrence after macroscopically complete surgery', '397 patients (12-month group, 199; 36-month group, 198; 201 men and 196 women; median [IQR] age, 62 (51-69) years and 60 (51-67) years, during a median follow-up time of 119 months after the date of randomization, 194 RFS events and 96 OS events were recorded in the intention-to-treat Population']",['adjuvant imatinib'],"['intra-abdominal metastases', '10-year RFS', '5-year OS and 10-year OS rates', 'recurrence-free survival (RFS', 'Survival Outcomes', 'overall survival (OS', 'RFS; the secondary objectives included OS and treatment safety']","[{'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0854198', 'cui_str': 'Metastases to abdominal cavity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",400.0,0.296023,"No new safety signals were detected.
","[{'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Oncology, Skåne University Hospital and Lund University, Lund, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Sundby Hall', 'Affiliation': 'Department of Oncology, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Reichardt', 'Affiliation': 'Helios Klinikum Berlin-Buch, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schütte', 'Affiliation': 'Schwerpunktpraxis Oncology/Hematology, Düsseldorf, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': 'Department of Gastroenterology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Division of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, Mannheim, Germany.'}, {'ForeName': 'Philipp J', 'Initials': 'PJ', 'LastName': 'Jost', 'Affiliation': 'Medical Department III, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Salah-Eddin', 'Initials': 'SE', 'LastName': 'Al-Batran', 'Affiliation': 'Klinik für Onkologie und Hämatologie am Krankenhaus Nordwest, Frankfurt, Germany.'}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lindner', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Sarcoma Center, West German Cancer Center, Essen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Wardelmann', 'Affiliation': 'Gerhard-Domagk-Institute of Pathology, University of Münster, Münster, Germany.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Nilsson', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Raija', 'Initials': 'R', 'LastName': 'Kallio', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Jaakkola', 'Affiliation': 'Department of Oncology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jouni', 'Initials': 'J', 'LastName': 'Junnila', 'Affiliation': '4Pharma Ltd, Turku, Finland.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Alvegård', 'Affiliation': 'Department of Cancer Epidemiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Helios Klinikum Berlin-Buch, Sarkomzentrum Berlin-Brandenburg, Berlin, Germany.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2091']
1250,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
1251,32474918,"An open-label cluster-randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19 (ARCHAIC)-Protocol publication.",,2020,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","['patients admitted with moderate to severe COVID-19 (ARCHAIC) - Protocol publication', 'COVID-19 in China']","['Chloroquine (CQ) and hydroxychloroquine (HCQ', 'chloroquine, hydroxychloroquine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0514377,"Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in moderate to severe COVID-19.","[{'ForeName': 'Jesper M', 'Initials': 'JM', 'LastName': 'Weehuizen', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",European journal of clinical investigation,['10.1111/eci.13297']
1252,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE


The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD


A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS


A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION


These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1253,32486583,[Efficacy and safety of levosimendan in elderly patients with severe heart failure].,"Objective:  To investigate the efficacy and safety of different dosage regimens of levosimendan in elderly patients with severe heart failure.  Methods:  Thirty-two patients 75 years or older were randomly divided into a loading dose group (16 cases) in which levosimendan was maintained at 0.1 μg·kg(-1)·min(-1) for 24 h after loaded with 6 μg/kg, and a maintenance dose group (16 cases) with same schedule without loading dose. The amino-terminal brain natriuretic peptide (NT-proBNP) before and after treatment was detected. Left ventricular ejection fraction (LVEF), stroke volume (SV), stroke volume index (SVI) by echocardiograph were monitored. Adverse events, the length of stay in ICU and 28-day mortality were recorded.  Results:  The NT-proBNP level in loading group after treatment was 1 950 (922,6 481)ng/L, which was improved than that before treatment [4 018(2 716,9 637)ng/L,  P <0.05]. The result was similar in maintenance group [1 390 (599,3 297)ng/L vs. 4 576 (2 681,10 682)ng/L,  P <0.05]. LVEF in loading group before and after treatment was (39.4±8.8) % vs. (48.9±9.2) % respectively, while in maintenance group it was (40.4±8.8) % vs. (48.7±12.0) % (both  P <0.05). SV were also improved after treatment in both groups compared with baseline levels ( P <0.05). NT-proBNP started to decline on day 3 in the loading group, while on day 7 in the maintenance group. SVI recovered on day 14 in the loading group [ (29.4±6.5) ml/m(2) vs. (27.3±6.7) ml/m(2), P <0.05], while it did not change much in the maintenance group. There was no significant differences as to the length of stay in ICU [ (11.1±4.4) d in loading group vs. (9.6±3.5) d in maintenance group] and 28-day mortality rates were comparable (2/16 in loading group vs. 1/16 in maintenance group) . The adverse events were 7 vs. 2 cases in loading group and maintenance group respectively, which were mild and all alleviated.  Conclusion:  The application of levosimendan only with maintenance dose improves cardiac function in very elderly patients with severe heart failure. Adverse events are mild and manageable.",2020,"NT-proBNP started to decline on day 3 in the loading group, while on day 7 in the maintenance group.","['Methods:  Thirty-two patients 75 years or older', 'elderly patients with severe heart failure', 'very elderly patients with severe heart failure']","['levosimendan', 'LVEF']","['Adverse events, the length of stay in ICU and 28-day mortality', 'SVI', 'efficacy and safety', 'SV', 'cardiac function', 'Left ventricular ejection fraction (LVEF), stroke volume (SV), stroke volume index (SVI', 'adverse events', 'length of stay in ICU', '28-day mortality rates', 'NT-proBNP level']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0432178,"NT-proBNP started to decline on day 3 in the loading group, while on day 7 in the maintenance group.","[{'ForeName': 'Y B', 'Initials': 'YB', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Yu', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Gong', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Care Unit, Zhejiang Hospital, Hangzhou 310013, China.'}]",Zhonghua nei ke za zhi,['10.3760/cma.j.cn112138-20190827-00587']
1254,32591933,Can reminders improve adherence to regular physical activity and exercise recommendations in people over 60 years old? : A randomized controlled study.,"PURPOSE


The purpose of the study was to investigate whether additional reminders could enhance adherence to a 12-week program consisting of regular physical activity.
METHODS


The study collective consisted of pensioners insured with the Austrian Insurance Fund for Civil or Public Servants. They were made aware of our program through the public service union. The subjects were randomized to an intervention group (group A) that received reminders and to a control group (group B) that did not receive such notifications. Adherence to physical activity was assessed by the use of diaries.
RESULTS


Group A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min). The Mann-Whitney U-test showed no significant differences (p = 0.080) between the study groups. There was no difference in muscle strengthening activity (group A: median: 2, r = 0-13 sessions; group B: median: 2, r = 0-20 sessions).
CONCLUSION


The major positive observation was that both the experimental and control group participants exceeded the recommended level of physical activity. Nevertheless, there were some differences concerning the minutes of physical activity performed in favor of the intervention group.",2020,"A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min).","['pensioners insured with the Austrian Insurance Fund for Civil or Public Servants', 'people over 60 years old']",['intervention group (group\xa0A) that received reminders and to a\xa0control group (group\xa0B) that did not receive such notifications'],"['muscle strengthening activity', 'moderate intensity regular physical activity', 'level of physical activity', 'Adherence to physical activity']","[{'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0253331,"A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min).","[{'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wolner-Strohmeyer', 'Affiliation': 'Wien Hauptstelle, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Vienna, Austria.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Keilani', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mähr', 'Affiliation': 'Therapiezentrum Rosalienhof, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Bad Tatzmannsdorf, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Morawetz', 'Affiliation': 'Wien Hauptstelle, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Vienna, Austria.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Palma', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mickel', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Galateja', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. richard.crevenna@meduniwien.ac.at.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01699-6']
1255,32594785,"Influence of timolol, benzalkonium-preserved timolol, and benzalkonium-preserved brimonidine on oxidative stress biomarkers in the tear film.","PURPOSE


The objective of this study was to investigate the influence of topical preservative-free timolol, benzalkonium chloride(BAC)-preserved timolol, BAC-preserved timolol, and BAC-preserved brimonidine on total protein concentration, advanced oxidation protein products (AOPP) content, total sulfhydryl groups content, the activity of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as Total Oxidant Status (TOS), Total Antioxidant Response, and Oxidative Stress Index (OSI) in the tear film.
METHODS


The patients were divided into four groups: group C ( n  = 25)-control group-subjects who did not use topical antiglaucoma medications, group T ( n  = 17)-patients using topical preservative-free timolol, group T + BAC ( n  = 24)-patients using topical BAC-preserved timolol, and group BR + BAC ( n  = 19)-patients using topical BAC-preserved brimonidine.
RESULTS


The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.
CONCLUSIONS


This indicates that using BAC-preserved topical medications increases oxidative stress in the tear film and may, in the long-term, contribute to the clinical presentation of dry eye disease.",2020,"Results:  The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.",[],"['preservative-free timolol', 'BAC-preserved topical medications', '25)-control group-subjects who did not use topical antiglaucoma medications, group T (n\u2009=\u200917)-patients using topical preservative-free timolol, group T\u2009+\u2009BAC (n\u2009=\u200924)-patients using topical BAC-preserved timolol, and group BR\u2009+\u2009BAC (n\u2009=\u200919)-patients using topical BAC-preserved brimonidine', 'brimonidine', 'timolol, benzalkonium-preserved timolol, and benzalkonium-preserved brimonidine', 'topical preservative-free timolol, benzalkonium chloride(BAC)-preserved timolol, BAC-preserved timolol, and BAC-preserved brimonidine']","['SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI', 'total protein concentration, advanced oxidation protein products (AOPP) content, total sulfhydryl groups content, the activity of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as Total Oxidant Status (TOS), Total Antioxidant Response, and Oxidative Stress Index (OSI', 'oxidative stress', 'oxidative stress biomarkers']",[],"[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0005025', 'cui_str': 'Benzalkonium'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium chloride'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0166171,"Results:  The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.","[{'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Sedlak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Weronika', 'Initials': 'W', 'LastName': 'Wojnar', 'Affiliation': 'Department of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zych', 'Affiliation': 'Department of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Katowice, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Wyględowska-Promieńska', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, Katowice, Poland.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2020.1787435']
1256,32607574,Relationship Between Intensive Care Unit Delirium Severity and 2-Year Mortality and Health Care Utilization.,"BACKGROUND


Critical care patients with delirium are at an increased risk of functional decline and mortality long term.
OBJECTIVE


To determine the relationship between delirium severity in the intensive care unit and mortality and acute health care utilization within 2 years after hospital discharge.
METHODS


A secondary data analysis of the Pharmacological Management of Delirium and Deprescribe randomized controlled trials. Patients were assessed twice daily for delirium or coma using the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Delirium severity was measured using the CAM-ICU-7. Mean delirium severity (from time of randomization to discharge) was categorized as rapidly resolving, mild to moderate, or severe. Cox proportional hazards regression was used to model time to death, first emergency department visit, and rehospitalization. Analyses were adjusted for age, sex, race, Charlson Comorbidity Index, Acute Physiology and Chronic Health Evaluation II score, discharge location, diagnosis, and intensive care unit type.
RESULTS


Of 434 patients, those with severe delirium had higher mortality risk than those with rapidly resolving delirium (hazard ratio 2.21; 95% CI, 1.35-3.61). Those with 5 or more days of delirium or coma had higher mortality risk than those with less than 5 days (hazard ratio 1.52; 95% CI, 1.07-2.17). Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations.
CONCLUSION


Increased delirium severity and days of delirium or coma are associated with higher mortality risk 2 years after discharge.",2020,"Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations.
",[],[],"['mortality risk', 'Mean delirium severity', 'Delirium severity and number of days of delirium or coma', 'Delirium severity', 'delirium or coma using the Richmond Agitation-Sedation Scale']",[],[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",434.0,0.192125,"Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations.
","[{'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Andrews', 'Affiliation': 'About the Authors: Patricia S. Andrews is an assistant professor, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant professor, Department of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Anthony J. Perkins is a staff biostatistician, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sikandar', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Sikandar Khan is an assistant professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and a research scientist, Indiana University Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Heidi Lindroth is a postdoctoral fellow, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and an affiliate at the Indiana University Center for Aging Research, Regenstrief Institute.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Malaz Boustani is a professor, Department of Medicine, Indiana University School of Medicine; the founding director, Center for Health Innovation and Implementation Science at Indiana Clinical Translational Science Institute; director of senior care innovation, Eskenazi Hospital; and a research scientist, Indiana University Center for Aging Research, Regen strief Institute.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Babar Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and a research scientist, Indiana University Center for Aging Research, Regenstrief Institute.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020498']
1257,32459666,Comparison of self- and nurse-measured office blood pressure in patients with chronic kidney disease.,"OBJECTIVE


As blood pressure (BP) control is very important in chronic kidney disease (CKD), we investigated how office BP is influenced by the measurement circumstances and compared nonautomated self- and nurse-measured BP values.
MATERIALS AND METHODS


Two hundred stage 1-5 CKD patients with scheduled visits to an outpatient clinic were randomized to either self-measured office BP (SMOBP) followed by nurse-measured office BP (NMOBP) or NMOBP followed by SMOBP. The participants had been educated to perform the self-measurement in at least one previous visit. The SMOBP and NMOBP measurement series both consisted of three recordings, and the means of the last two recordings during SMOBP and NMOBP were compared for the 174 (mean age 52.5 years) with complete BP data.
RESULTS


SMOBP and NMOBP showed similar systolic (135.3 ± 16.6 vs 136.4 ± 17.4 mmHg, Δ = 1.1 mmHg, P = 0.13) and diastolic (81.5 ± 10.2 vs 82.2 ± 10.4 mmHg, Δ = 0.6 mmHg, P = 0.09) values. The change in BP from the first to the third recording was not different for SMOBP and NMOBP. In 17 patients, systolic SMOBP was ≥10 mmHg higher than NMOBP and in 28 patients systolic NMOBP exceeded SMOBP by ≥10 mmHg. The difference between systolic SMOBP and NMOBP was independent of CKD stage and the number of medications, but significantly more pronounced in patients above 60 years.
CONCLUSION


In a population of CKD patients, there is no clinically relevant difference in SMOBP and NMOBP when recorded at the same visit. However, in 25% of the patients, systolic BP differs ≥10 mmHg between the two measurement modalities.",2020,"The difference between systolic SMOBP and NMOBP was independent of CKD stage and the number of medications, but significantly more pronounced in patients above 60 years.
","['Two hundred stage 1-5 CKD patients with scheduled visits to an outpatient clinic', 'chronic kidney disease (CKD', 'patients with chronic kidney disease']","['self-measured office BP (SMOBP) followed by nurse-measured office BP (NMOBP) or NMOBP followed by SMOBP', 'self- and nurse-measured office blood pressure']","['systolic SMOBP', 'systolic SMOBP and NMOBP', 'similar systolic', 'diastolic', 'systolic BP', 'change in BP', 'SMOBP and NMOBP']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}]",,0.0287159,"The difference between systolic SMOBP and NMOBP was independent of CKD stage and the number of medications, but significantly more pronounced in patients above 60 years.
","[{'ForeName': 'Birgitte Godskesen', 'Initials': 'BG', 'LastName': 'Tougaard', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Kathrine Skaaning', 'Initials': 'KS', 'LastName': 'Laursen', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Jens Dam', 'Initials': 'JD', 'LastName': 'Jensen', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Buus', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000453']
1258,32469384,Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial.,"Importance


Papillary renal cell carcinoma (PRCC) is the most common type of non-clear cell RCC. Because some cases of PRCC are MET-driven, MET inhibition could be a targeted treatment approach. In previous studies, savolitinib (AZD6094, HMPL-504, volitinib), a highly selective MET-tyrosine kinase inhibitor, demonstrated antitumor activity in this patient group.
Objective


To determine whether savolitinib is a better treatment option for this patient population, vs standard of care, sunitinib.
Design, Setting, and Participants


The SAVOIR phase 3, open-label, randomized clinical trial was a multicenter study carried out in 32 centers in 7 countries between July 2017 and the data cutoff in August 2019. Overall, 360 to 450 patients were to be screened to randomize approximately 180 patients. Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions. Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment. Overall, 254 patients were screened.
Interventions


Patients received 600 mg of savolitinib orally once daily (qd), or 50 mg of sunitinib orally qd for 4 weeks, followed by 2 weeks without treatment.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS, assessed by investigator and confirmed by blinded independent central review). Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability.
Results


At data cutoff, 60 patients were randomized (savolitinib n = 33; sunitinib n = 27); most patients had chromosome 7 gain (savolitinib, 30 [91%]; sunitinib, 26 [96%]) and no prior therapy (savolitinib, 28 [85%]; sunitinib, 25 [93%]). For savolitinib and sunitinib, 4 (12%) and 10 (37%) patients were women, and the median (range) age was 60 (23-78) and 65 (31-77) years, respectively. Following availability of external data on PFS with sunitinib in patients with MET-driven disease, study enrollment was closed. Progression-free survival, OS, and ORR were numerically greater with savolitinib vs sunitinib. Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31). For savolitinib and sunitinib respectively, grade 3 or higher adverse events (AEs) were reported in 14 (42%) and 22 (81%) of patients and AE-related dose modifications in 10 (30%) and 20 (74%). After discontinuation, 12 (36%) and 5 (19%) of patients on savolitinib and sunitinib respectively, received subsequent anticancer therapy.
Conclusions and Relevance


Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy vs sunitinib, with fewer grade 3 or higher AEs and dose modifications. Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT03091192.",2020,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","['360 to 450 patients were to be screened, to randomize approximately 180 patients', 'Importance\n\n\nPapillary renal cell carcinoma ', '32 centers in 7 countries between July 2017 and the data cutoff in August 2019', '60 patients were randomized (savolitinib n\u2009=\u200933', '254 patients were screened', 'Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment', 'patients with MET-driven disease, study enrollment was closed', 'Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions', 'Patients With MET-Driven Papillary Renal Cell Carcinoma']","['PRCC', 'Savolitinib vs Sunitinib']","['progression-free survival (PFS', 'Median PFS', 'overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability', 'Progression-free survival, OS, and ORR']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.307135,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Cancel', 'Affiliation': 'CHU Bretonneau Centre, Tours University, France.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Lone H', 'Initials': 'LH', 'LastName': 'Ottesen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Frigault', 'Affiliation': 'Oncology R&D, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Hernault"", 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szijgyarto', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2218']
1259,32472172,Intravitreal ranibizumab alone or in combination with panretinal photocoagulation for the treatment of proliferative diabetic retinopathy with coexistent macular edema: long-term outcomes of a prospective study.,"AIMS


To compare intravitreal ranibizumab as monotherapy or in combination with panretinal photocoagulation (PRP) in patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME) in a long-term follow-up of 24 months.
METHODS


Participants in this prospective study were 47 patients with PDR and concurrent DME, who were randomized at baseline into two groups: (i) the ""ranibizumab alone"" group (n = 23), which was treated with at least 3 intravitreal ranibizumab injections as a loading phase, and (ii) the ""combination"" group (n = 24), which was treated with PRP and at least 3 intravitreal ranibizumab injections. Thereafter, all patients were followed up at a pro re nata (PRN) basis, with regular monthly monitoring for 24 months. At each visit, best corrected visual acuity (BCVA) and spectral domain-optical coherence tomography were performed, while regression of neovascularization was also recorded.
RESULTS


The ""combination"" group had better control of neovascularization and less events of vitreous hemorrhage than ranibizumab alone through the 2 years. BCVA did not differ significantly between the two groups at months 12 and 24 of the follow-up. The ""ranibizumab"" alone group presented greater reduction in central retinal thickness at month 12, which did not reach significance at month 24 compared to ""combination"" group. Greater number of injections was needed in the monotherapy group (mean 14 injections) compared to ""combination"" group (mean 11 injections) through month 24.
CONCLUSIONS


Both intravitreal ranibizumab alone or in combination with PRP could be used effectively for the treatment of PDR and coexistent DME. Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.",2020,"Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.","['patients with proliferative diabetic retinopathy (PDR) and coexistent diabetic macular edema (DME', 'proliferative diabetic retinopathy with coexistent macular edema', 'Participants in this prospective study were 47 patients with PDR and concurrent DME']","['ranibizumab alone"" group', 'ranibizumab injections', 'panretinal photocoagulation (PRP', 'intravitreal ranibizumab', 'Intravitreal ranibizumab alone or in combination with panretinal photocoagulation', 'ranibizumab']","['BCVA and CRT', 'Greater number of injections', 'vitreous hemorrhage', 'central retinal thickness', 'control of neovascularization', 'BCVA', 'corrected visual acuity (BCVA) and spectral domain-optical coherence tomography']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0730064', 'cui_str': 'Panretinal photocoagulation'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027686', 'cui_str': 'Neovascularization'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]",47.0,0.0173837,"Even though there was no difference in BCVA and CRT at the 24-month follow-up between the two groups, the combination group presented greater regression of neovascularization with less injections.","[{'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Chatziralli', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece. eirchat@yahoo.gr.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Dimitriou', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kazantzis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}]",Acta diabetologica,['10.1007/s00592-020-01548-y']
1260,32483072,Outcomes of resident-performed laser-assisted vs traditional phacoemulsification.,"PURPOSE


To compare the effectiveness of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification cataract surgery (CPS) by resident surgeons.
SETTING


Parkland Memorial Health and Hospital System, Dallas, Texas, USA.
DESIGN


Prospective randomized study.
METHODS


All surgeries to be performed by postgraduate year 3 and year 4 residents from October 2015 through June 2017 were eligible for inclusion. Patients were required to complete postoperative day 1, week 1, month 1, and month 3 visits. Specular microscopy was performed preoperatively and postoperatively. Surgeries were filmed, and each step was timed and compared. Surgeon and patient surveys were filled out postoperatively.
RESULTS


Of the 135 eyes of 96 subjects enrolled in the study, 64 eyes received FLACS and 71 eyes received CPS. There was no significant difference in corrected distance visual acuity (CDVA), either preoperatively or at the postoperative day 1, week 1, month 1, or month 3 visits (P = .469, .539, .701, .777, and .777, respectively). Cumulated dissipated energy and irrigation fluid usage were not different between FLACS and CPS (P = .521 and .368, respectively), nor was there a difference in the reduction of endothelial cell counts postoperatively (P = .881). Wound creation (P = .014), cortical cleanup (P = .009), and IOL implantation (P = .031) were faster in the CPS group. Survey results indicated that the overall patient experience was similar for FLACS and CPS.
CONCLUSIONS


This first prospective randomized trial evaluating resident-performed FLACS shows that, in resident hands, FLACS provides similar results to CPS regarding visual acuity, endothelial cell loss, operative time, patient satisfaction, and surgical complication rate.",2020,"There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively).","['All surgeries to be performed by PGY-3 & 4 residents from October 2015 through June 2017 were eligible for inclusion', 'Of the 135 eyes of 96 subjects enrolled in the study, 64 eyes received']","['Resident-Performed Laser-Assisted vs Traditional Phacoemulsification', 'CPS', 'conventional phacoemulsification cataract surgery (CPS', 'FLACS', 'femtosecond laser-assisted cataract surgery (FLACS']","['IOL implantation', 'Cumulated dissipated energy and irrigation fluid usage', 'best corrected visual acuity (BCVA', 'visual acuity, endothelial cell loss, operative time, patient satisfaction, and surgical complication rate', 'endothelial cell counts', 'cortical cleanup', 'Wound creation']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0149958', 'cui_str': 'Partial Seizures, Complex'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}]","[{'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0441513', 'cui_str': 'Construction'}]",96.0,0.0403187,"There was no significant difference in best corrected visual acuity (BCVA), either preoperatively or at the postop day 1, week 1, month 1, or month 3 visits (P= 0.469, 0.539, 0.701, 0.777, and 0.777 respectively).","[{'ForeName': 'Brock', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'From the Department of Ophthalmology, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Preston H', 'Initials': 'PH', 'LastName': 'Blomquist', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ririe', 'Affiliation': ''}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Pouly', 'Affiliation': ''}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'W Matthew', 'Initials': 'WM', 'LastName': 'Petroll', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'McCulley', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000253']
1261,32479807,Short-Term Changes in Prediction Error after Cataract Surgery in Eyes Receiving 1 of 3 Types of Single-Piece Acrylic Intraocular Lenses.,"PURPOSE


To compare short-term changes in refractive prediction error (PE) after phacoemulsification among eyes receiving different types of single-piece acrylic intraocular lenses (IOLs).
DESIGN


Randomized clinical trial.
METHODS


A total of 195 eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL were randomly assigned to receive 1 of 3 IOLs: 1) an Alcon model SN60WF, 2) a Hoya model XY-1, or 3) an AMO model ZCB00V. Manifest spherical equivalent (MRSE) value, PE, and changes in PE were examined at 1 day and at 1 and 2 months postoperatively and were compared among groups.
RESULTS


The mean MRSE and PE significantly changed toward myopia between 1 day and 2 months postoperatively in all groups (P < .0001). The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P ≤ .0006). The PE change between 1 day and 2 months postoperatively was significantly smaller in the SN60WF group than in the other groups (P = .0062). IOL type and changes in anterior chamber depth and corneal curvature independently correlated with PE changes.
CONCLUSIONS


The MRSE and PE showed a significant myopic change for 2 months postoperatively in eyes implanted with 1 of 3 types of single-piece acrylic IOLs and were significantly smaller in the SN60WF than in the XY-1 and ZCB00V groups. Changes in PE during the 2 postoperative months were smaller in the SN60WF IOLs than in the other IOLs, suggesting that postoperative refractive stability differs among single-piece acrylic IOLs.",2020,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","['One-hundred ninety-five eyes of 195 patients scheduled for implantation of a single-piece acrylic IOL', 'eyes receiving different types of single-piece acrylic intraocular lenses (IOLs']",['SN60WF'],"['PE change', 'IOL type, and changes in anterior chamber depth and corneal curvature', 'mean MRSE and PE', 'MRSE and PE', 'AMO ZCB00V. Manifest spherical equivalent value (MRSE), PE, and changes in PE', 'refractive prediction error (PE']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",195.0,0.0496226,"The MRSE and PE did not differ significantly among groups at 1 day and 1 month postoperatively, and were significantly smaller in the SN60WF group than in the XY-1 and ZCB00V groups at 2 months (P≤.0006).","[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan. Electronic address: hayashi-ken@hayashi.or.jp.'}, {'ForeName': 'Motoaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Hayashi', 'Affiliation': 'Department of Ophthalmology, National Hospital Organization Saitama Hospital, Saitama, Japan; Department of Ophthalmology, Keio University Faculty of Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Hayashi Eye Hospital, Fukuoka, Japan.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.05.031']
1262,32487120,The long and winding road to happiness: A randomized controlled trial and cost-effectiveness analysis of a positive psychology intervention for lonely people with health problems and a low socio-economic status.,"BACKGROUND


Our objective was to evaluate the effectiveness and cost-effectiveness of the positive psychology intervention 'Happiness Route' compared to an active control condition in a vulnerable population with an accumulation of health and psychosocial problems.
METHODS


We conducted a randomized, single-blind, actively-controlled, parallel group study in seven municipalities in the Netherlands. To be eligible, participants had to experience loneliness, health problems and low socio-economic status. Each group received several home visits by a counsellor (two in the control condition, two to six in the experimental condition). In the Happiness Route, a happiness-based approach was used, whereas the control condition used a traditional problem-based approach. The primary outcome was well-being, measured with the Mental Health Continuum-Short Form (MHC-SF).
RESULTS


Fifty-eight participants were randomized to the Happiness Route, 50 to the control condition. Participants were severely lonely, had on average three health problems and less than 5% had paid work. The total MHC-SF score, emotional and social well-being, depression and loneliness improved significantly over the nine-month period in both conditions (p < .05), but there were no significant changes between the conditions across time. Languishing decreased significantly from 33% at baseline to 16% at follow-up among the Happiness Route participants but did not change significantly in the control condition. No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation. Cost-effectiveness analysis showed that expected saved costs per QALY lost was €219,948 for the Happiness Route, relative to the control condition. The probability was 83% that the Happiness Route was cost saving and 54% that the Happiness Route was cost-effective at a willingness to accept a threshold of €100,000.
CONCLUSIONS


Mental health status of both groups improved considerably. However, we could not demonstrate that the Happiness Route yielded better health outcomes compared to the control condition. Nevertheless, the results of the cost-effectiveness analysis suggested that the Happiness Route is an acceptable intervention from a health-economic point of view. Our results should be viewed in light of the fact that we could not include the planned number of participants.
TRIAL REGISTRATION


Netherlands Trial Register: NTR3377. Registered 2 Apr 2012.",2020,"No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation.","['Fifty-eight participants', 'participants had to experience loneliness, health problems and low socio-economic status', 'lonely people with health problems and a low socio-economic status', 'Participants were severely lonely, had on average three health problems and less than 5% had paid work', 'seven municipalities in the Netherlands']","['NTR3377', 'positive psychology intervention', ""positive psychology intervention 'Happiness Route""]","['total MHC-SF score, emotional and social well-being, depression and loneliness', 'psychological well-being, resilience, purpose in life, health-related quality of life and social participation', 'effectiveness and cost-effectiveness', 'well-being, measured with the Mental Health Continuum-Short Form (MHC-SF', 'health outcomes']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",58.0,0.0683567,"No significant improvement over time was found in psychological well-being, resilience, purpose in life, health-related quality of life and social participation.","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Weiss', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands. weiss.laura.a@gmail.com.'}, {'ForeName': 'Martijn A H', 'Initials': 'MAH', 'LastName': 'Oude Voshaar', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}, {'ForeName': 'Gerben J', 'Initials': 'GJ', 'LastName': 'Westerhof', 'Affiliation': 'Faculty of Behavioural, Management & Social Sciences, Department of Psychology, Health & Technology, Centre for eHealth and Wellbeing Research, University of Twente, Postbus 217, 7500 AE, Enschede, The Netherlands.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01416-x']
1263,32581042,Serum interleukin-6 and C-reactive protein are associated with survival in melanoma patients receiving immune checkpoint inhibition.,"BACKGROUND


Inflammatory mediators, including acute phase reactants and cytokines, have been reported to be associated with clinical efficacy in patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI). Analyses of patient sera from three large phase II/III randomized ICI trials, one of which included a chemotherapy arm, were performed to assess whether baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios were prognostic or predictive.
PATIENTS AND METHODS


Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of nivolumab followed by ipilimumab or the reverse sequence. Baseline sera, and peripheral blood mononuclear cells using automated cell counting, were analyzed from treatment-naïve patients who were BRAF wild-type and randomly allocated 1:1 to receive nivolumab or dacarbazine on the phase III Checkmate-066 trial, and from treatment-naïve patients allocated 1:1:1 to receive nivolumab, ipilimumab or both ipilimumab and nivolumab on the phase III Checkmate-067 trial.
RESULTS


Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy. Increased on-treatment levels of IL-6 in patients on the Checkmate-064 study were also associated with shorter survival. IL-6 levels from patients on Checkmate-064, Checkmate-066 and Checkmate-067 were highly correlated with levels of CRP and the N/L ratio.
CONCLUSION


IL-6, CRP and the N/L ratio are prognostic factors with higher levels associated with shorter overall survival in patients with metastatic melanoma receiving ICI or chemotherapy in large randomized trials. In a multi-variable analysis of the randomized phase III Checkmate-067 study, IL-6 was a significant prognostic factor for survival.",2020,"RESULTS


Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","['melanoma patients receiving immune checkpoint inhibition', 'Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of', 'patients with metastatic melanoma receiving', 'patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI', 'naïve patients who were BRAF wild-type']","['nivolumab, ipilimumab or both ipilimumab and nivolumab', 'nivolumab followed by ipilimumab', 'nivolumab or dacarbazine', 'ICI or chemotherapy']","['baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios', 'IL-6 levels', 'overall survival', 'IL-6', 'shorter survival']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.152016,"RESULTS


Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","[{'ForeName': 'Andressa S', 'Initials': 'AS', 'LastName': 'Laino', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, University of Colorado Denver-Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Vassallo', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA Jeffrey.Weber@nyulangone.org.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000842']
1264,32583712,Use of traction table did not increase complications in total hip arthroplasty through direct anterior approach performed by novice surgeon.,"PURPOSE


The purpose of this study was to investigate the surgical outcomes of total hip arthroplasty (THA) through direct anterior approach (DAA) performed by beginners by comparing the outcomes after the introduction of DAA-THA between using a normal operating table and a traction table.
METHODS


The total subjects were 200 patients, there were 120 cases from the introduction of three surgeons using a normal table and 80 cases from two surgeons using a traction table. The surgical procedure was standardized, and a surgeon skilled in DAA entered the operating room and instructed the novice surgeons of DAA in all cases.
RESULTS


The mean operative time was no significant difference between the two groups ( p  = 0.093). The difference in slope of the operative time was no significant difference between the two groups ( p  value = 0.089). The mean fluoroscopy time and the mean blood loss were significant difference between the two groups ( p  < 0.05). The difference in slope of the fluoroscopy time and blood loss were significant difference between the two groups ( p  < 0.05). There were no intraoperative complications and no reoperations for any reason.
CONCLUSIONS


At the facility with a surgeon skilled in DAA, the use of a traction table in DAA did not increase the complication rate compared with the use of a normal operating table when the exclusion criteria for DAA were set and surgery was performed using intraoperative fluoroscopy under supervision by a skilled surgeon.",2020,The mean fluoroscopy time and the mean blood loss were significant difference between the two groups ( p  < 0.05).,"['total subjects were 200 patients, there were 120 cases from the introduction of three surgeons using a normal table and 80 cases from two surgeons using a traction table']","['traction table', 'total hip arthroplasty (THA) through direct anterior approach (DAA']","['intraoperative complications', 'slope of the operative time', 'mean operative time', 'complication rate', 'slope of the fluoroscopy time and blood loss', 'mean fluoroscopy time and the mean blood loss']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0183817', 'cui_str': 'Traction table'}]","[{'cui': 'C0183817', 'cui_str': 'Traction table'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",200.0,0.0249639,The mean fluoroscopy time and the mean blood loss were significant difference between the two groups ( p  < 0.05).,"[{'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Banno', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Tanabe', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Homma', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Ochi', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taiji', 'Initials': 'T', 'LastName': 'Watari', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Department of Orthopaedic Surgery, Juntendo University School of Medicine, Tokyo, Japan.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020923093']
1265,32585670,Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 Study.,"INTRODUCTION


Control of hyperphosphatemia in patients on dialysis remains a major challenge.
OBJECTIVE


This study evaluated predictors of serum phosphorus (sP) control among dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial.
METHODS


Post hoc analyses were performed using data for patients with hyperphosphatemia who received 52 weeks of treatment with sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer). Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52). Because SFOH and sevelamer have previously demonstrated similar effects on chronic kidney disease-mineral-bone disorder parameters in this study, the treatment groups were pooled.
RESULTS


Average age at baseline was higher among sP-controlled versus sP-uncontrolled patients (56.9 vs. 53.4 years; p = 0.005). Baseline sP levels were significantly lower among sP-controlled versus sP-uncontrolled patients (7.30 vs. 7.85 mg/dL; p < 0.001), and sP reductions from baseline were significantly greater in the sP-controlled group (-2.89 vs. -0.99 mg/dL at week 52; p < 0.001). Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]: 0.765-0.960), no concomitant active vitamin D therapy use (OR = 0.51, 95% CI: 0.328-0.804), and higher body mass index at baseline (OR = 0.96, 95% CI: 0.937-0.992) as significant predictors of uncontrolled sP.
CONCLUSION


This analysis indicates that sP control may be more challenging in younger patients with high sP levels. Closer monitoring and management of serum phosphorus levels may be required in this population.",2020,"Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]:","['younger patients with high sP levels', 'patients with hyperphosphatemia who received 52 weeks of treatment with', 'dialysis patients treated with noncalcium, oral phosphate binder therapy in a phase 3 clinical trial', 'Patients were categorized into those who achieved sP control (n = 302; defined as sP ≤ 5.5 mg/dL at week 52), and those with uncontrolled sP (n = 195; sP >5.5 mg/dL at week 52']","['Sevelamer Carbonate', 'sucroferric oxyhydroxide (SFOH) or sevelamer carbonate (sevelamer']","['Baseline sP levels', 'chronic kidney disease-mineral-bone disorder parameters', 'higher body mass index', 'sP reductions']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4517624', 'cui_str': '195'}]","[{'cui': 'C1721288', 'cui_str': 'Sevelamer carbonate'}, {'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}, {'cui': 'C0718050', 'cui_str': 'sevelamer'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",302.0,0.0379352,"Logistic regression analysis identified higher baseline sP levels (odds ratio [OR] = 0.86, 95% confidence interval [CI]:","[{'ForeName': 'Adrian C', 'Initials': 'AC', 'LastName': 'Covic', 'Affiliation': 'Nephrology Clinic and Dialysis and Transplantation Center, Grigore T. Popa University of Medicine and Pharmacy, Iași, Romania, accovic@gmail.com.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'NorthShore University Health System, University of Chicago, Pritzker School of Medicine, Evanston, Illinois, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Division of Nephrology, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Ketteler', 'Affiliation': 'Department of General Internal Medicine and Nephrology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Walpen', 'Affiliation': 'Department of Medical Affairs, Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Perrin', 'Affiliation': 'Department of Biometrics, Vifor Pharma, Glattbrugg, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology, RWTH University Hospital Aachen, Aachen, Germany.'}]",Nephron,['10.1159/000507258']
1266,32586643,Axial or Helical? CT imaging of the thorax for dyspnoea patients with free-breathing using 16 cm wide-detector CT.,"AIM


To compare image quality and radiation dose between fast-helical mode (FHM) and two-axial mode (TAM) in chest computed tomography (CT) with 16 cm wide-detector for emergency patients with dyspnoea.
MATERIALS AND METHODS


Ninety-six emergency chest CT patients who cannot comply with breathing instructions were prospectively divided randomly into two groups: the FHM group (n=48, helical scan with 80 mm collimation and pitch 0.992:1), the TAM group (n=48, two axial scans with 160 mm collimation). Both groups used 0.28 seconds rotation speed and automatic tube current modulation. All scans were performed in free breathing. CT value, image noise, and signal-to-noise ratio (SNR) were measured on the descending thoracic aorta, lung parenchyma, and paraspinal muscle at the carina level. Two radiologists assessed images for subjective image quality, motion artefacts and diagnostic confidence. The volume CT dose index and dose-length product (DLP) were evaluated and effective dose (ED) was calculated.
RESULTS


The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05). TAM resulted in 24% lower DLP (96.76±31.58 versus 126.99±33.37 mGy·cm) and ED (1.36±0.44 versus 1.78±0.47 mSv) than FHM (p<0.001), but there was no difference in the CT value, image noise, and SNR between the two groups (p>0.05).
CONCLUSIONS


TAM with 16 cm detector coverage further reduces the exposure time in chest CT for dyspnoea patients and ensures good image quality with 24% radiation dose reduction, compared with fast-helical chest CT with 80 mm collimation.",2020,"The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05).","['emergency patients with dyspnoea', 'Ninety-six emergency chest CT patients who cannot comply with breathing instructions', 'dyspnoea patients with free-breathing using 16 cm wide-detector CT']","['FHM group (n=48, helical scan with 80 mm collimation and pitch 0.992:1), the TAM', 'fast-helical mode (FHM) and two-axial mode (TAM', 'FHM', 'TAM']","['exposure time', 'CT value, image noise, and SNR', 'subjective image quality, motion artefacts and diagnostic confidence', 'DLP', 'frequency of motion artefacts', 'CT value, image noise, and signal-to-noise ratio (SNR', 'volume CT dose index and dose-length product (DLP', 'diagnostic confidence score']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0454169', 'cui_str': 'Collimator'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0240973,"The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'GE Healthcare, Computed Tomography Research Center, Beijing, 100176, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: yj1118@mail.xjtu.edu.cn.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: xjyjsz@163.com.""}]",Clinical radiology,['10.1016/j.crad.2020.05.014']
1267,32586693,"Peer Companionship for Mental Health of Older Adults in Primary Care: A Pragmatic, Nonblinded, Parallel-Group, Randomized Controlled Trial.","OBJECTIVES


To determine whether peer companionship delivered by an aging services agency to socially-disconnected older adult primary care patients was associated with improvement in suicidal ideation depression, anxiety, and psychological connectedness.
DESIGN


Pragmatic, nonblinded, parallel-group, randomized controlled trial comparing peer companionship, The Senior Connection (TSC), to care-as-usual (CAU).
SETTING


Lifespan, a nonmedical, community-based aging services agency.
PARTICIPANTS


Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others.
INTERVENTION


TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls in the subjects' homes. CAU involved no peer companion assignment.
MEASUREMENTS


The primary outcome was suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others. Data were collected at baseline, 3-, 6-, and 12-months.
RESULTS


Subjects (55% female) had a mean age of 71 years. There was no difference between groups in change in suicidal ideation or belonging. Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01).
CONCLUSIONS


TSC was superior to CAU for improving depression, anxiety, and perceived burden, but not suicidal ideation. Although effect sizes were small, the low-cost and nationwide availability of peer companionship justify further examination of its effectiveness and scalability in improving mental health outcomes of socially disconnected older adults.",2020,"Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01).
","['socially disconnected older adults', 'Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others', 'Older Adults in Primary Care', 'Subjects (55% female) had a mean age of 71 years', 'Lifespan, a nonmedical, community-based aging services agency', 'to socially-disconnected older adult primary care patients']","['TSC', 'Peer Companionship', 'peer companionship delivered by an aging services agency', 'TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls', 'CAU', 'peer companionship, The Senior Connection (TSC), to care-as-usual (CAU']","['depression, anxiety, and perceived burden', 'anxiety', 'suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others', 'mental health outcomes', 'suicidal ideation', 'suicidal ideation depression, anxiety, and psychological connectedness', 'depression']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.118022,"Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01).
","[{'ForeName': 'Yeates', 'Initials': 'Y', 'LastName': 'Conwell', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY. Electronic address: yeates_conwell@urmc.rochester.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Van Orden', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Injury Prevention (DMS, WLKWM), Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Wendy LiKamWa', 'Initials': 'WL', 'LastName': 'McIntosh', 'Affiliation': 'Division of Injury Prevention (DMS, WLKWM), Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Messing', 'Affiliation': 'Department of Biostatistics and Computational Biology (SM, KAK), University of Rochester School of Medicine, NY.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Rowe', 'Affiliation': 'Lifespan of Greater Rochester, Inc. (JR), NY.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Podgorski', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Kaukeinen', 'Affiliation': 'Department of Biostatistics and Computational Biology (SM, KAK), University of Rochester School of Medicine, NY.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tu', 'Affiliation': 'Department of Family Medicine and Public Health, Division of Biostatistics and Bioinformatics (XT), UC San Diego School of Medicine, La Jolla, CA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.021']
1268,32588738,"Similar early functional recovery after total knee replacement comparing single shot versus continuous saphenous nerve block: A randomised, double-blind trial.","PURPOSE


Total knee replacement (TKR) is associated with post-operative pain. Femoral nerve block can relieve the pain but also affects the post-operative mobility. Saphenous nerve block (SNB) can improve analgesia without interfering mobilisation. However, there is no consensus on the ideal mode of administration of SNB. We aim to compare the effects of single shot versus continuous SNB on patients undergoing TKR.
METHODS


Patients were randomised into two groups: single shot and continuous SNB groups. Post-operative rehabilitation and mobilisation were assessed by blinded physiotherapists, and preoperative and post-operative American knee scores were recorded by blinded specialised nurse. Post-operative analgesics usage was recorded by blinded pain nurses and anaesthetists.
RESULTS


Sixty-four patients were recruited; 6 patients withdrew with 29 patients in each group. There is no significant difference in early mobilisation and rehabilitation comparing both groups. The mean of the range gained on day 2 when compared to day 1 in single-shot SNB group was 17.41 ± 19.67° versus continuous SNB group was 23.45 ± 19.18° ( p  = 0.149). The mean of the range gained on day 3 when compared to day 1 in single-shot group was 27.24 ± 22.66° versus continuous SNB group was 29.31 ± 21.57° ( p  = 0.6). The mean of maximum flexion achieved by day 3 in single-shot SNB group was 92.41 ± 9.6° versus continuous SNB was 91.90 ± 7.95° ( p  = 0.84). The day of reaching maximum flexion and the goal of 40 m showed no significant difference. Length of stay (LOS), difference in post-operative American Knee Society knee score at 3 months and analgesics usage showed no significant difference.
CONCLUSION


There is no significant difference in comparing the effect on mobilisation, LOS, early clinical outcome, analgesics usage in the single-shot group and the continuous SNB group.",2020,"There is no significant difference in comparing the effect on mobilisation, LOS, early clinical outcome, analgesics usage in the single-shot group and the continuous SNB group.","['patients undergoing TKR', 'Patients', 'Sixty-four patients were recruited; 6 patients withdrew with 29 patients in each group']","['total knee replacement comparing single shot versus continuous saphenous nerve block', 'Saphenous nerve block (SNB', 'Total knee replacement (TKR', 'single shot versus continuous SNB']","['mobilisation, LOS, early clinical outcome, analgesics usage', 'pain', 'mean of maximum flexion', 'early mobilisation and rehabilitation', 'Length of stay (LOS), difference in post-operative American Knee Society knee score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394744', 'cui_str': 'Local anesthetic saphenous nerve block'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.0970219,"There is no significant difference in comparing the effect on mobilisation, LOS, early clinical outcome, analgesics usage in the single-shot group and the continuous SNB group.","[{'ForeName': 'Ho Yee Joyce', 'Initials': 'HYJ', 'LastName': 'Lam', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}, {'ForeName': 'Yan Ho Bruce', 'Initials': 'YHB', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}, {'ForeName': 'Hok Leung', 'Initials': 'HL', 'LastName': 'Wong', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}, {'ForeName': 'Isaac Bruce', 'Initials': 'IB', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics and Traumatology, Pok Oi Hospital, Hong Kong SAR.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020932037']
1269,32596882,Cognitive behavioural therapy for insomnia does not appear to have a substantial impact on early markers of cardiovascular disease: A preliminary randomized controlled trial.,"According to the World Health Organization, cardiovascular diseases are the leading cause of death in the world. Therefore, early prevention of these diseases is a public health priority. Epidemiological data suggest that insomnia may be a modifiable risk factor for cardiovascular diseases. A randomized controlled trial in a sample of insomnia patients without cardiovascular disease was conducted to investigate the effects of insomnia treatment on early markers of cardiovascular diseases assessed by 24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples. Forty-six patients with insomnia disorder were randomized to cognitive behavioural therapy for insomnia (CBT-I; n = 23) or a waitlist control condition (n = 23). Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3). Potential methodological and conceptual reasons for these negative findings are discussed. Future studies might include larger sample sizes that are at risk of cardiovascular diseases and focus on other cardiovascular markers.",2020,"Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3).","['Forty-six patients with insomnia disorder', 'insomnia patients without cardiovascular disease']","['Cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia (CBT-I; n\xa0=\xa023) or a waitlist control condition']","['early markers of cardiovascular disease', '24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",46.0,0.0606613,"Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3).","[{'ForeName': 'Anna Friederike', 'Initials': 'AF', 'LastName': 'Johann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hertenstein', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, Bern, Switzerland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Feige', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Umair', 'Initials': 'U', 'LastName': 'Akram', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Holub', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Baglioni', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nissen', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, Bern, Switzerland.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Sleep and Circadian Neuroscience Institute (SCNi), University of Oxford, Oxford, UK.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Riemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Biermann', 'Affiliation': 'Department of Cardiology and Angiology, Cardiac Electrophysiology, St. Franziskus-Hospital Münster, Münster, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}]",Journal of sleep research,['10.1111/jsr.13102']
1270,32593323,"Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.","BACKGROUND


Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs.
METHODS


In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing.
FINDINGS


Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; p non-inferiority =0·034, p superiority =0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; p non-inferiority =0·0058, p superiority =0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups.
INTERPRETATION


The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves.
FUNDING


Abbott.",2020,"The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days.","['high and extreme risk patients with severe aortic stenosis (PORTICO IDE', '1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369', 'risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia', 'Mean age was 83 years (SD 7) and 395 (52·7%) patients were female', 'Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis', 'Eligible patients']","['self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA', 'transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT', 'Self-expanding intra-annular versus commercially available transcatheter heart valves']","['event rate', 'intention to treat and the Kaplan-Meier method to estimate event rates', 'cause mortality or disabling stroke', 'disabling stroke', 'composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days', 'safety and efficacy', 'rates of death', 'Clinical outcomes and valve performance', 'rates of death or disabling stroke', 'rates of the primary efficacy endpoint']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C4302018', 'cui_str': 'Bleeding requiring transfusion'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.297403,"The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days.","[{'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: raj.makkar@cshs.org.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Groh', 'Affiliation': 'Mission Health and Hospitals, Asheville, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abernethy', 'Affiliation': 'Mission Health and Hospitals, Asheville, NC, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Russo', 'Affiliation': 'Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA; Newark Beth Israel Medical Center, Newark, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heimansohn', 'Affiliation': 'St Vincent Heart Center, Indianapolis, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hermiller', 'Affiliation': 'St Vincent Heart Center, Indianapolis, IN, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Worthley', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, SA, Australia; Genesis Care, Sydney, NSW, Australia.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Chehab', 'Affiliation': 'Cardiovascular Research Institute of Kansas, Ascension Via Christi Hospital, Wichita, KS, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cunningham', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Matthews', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Ramana', 'Affiliation': 'Advocate Christ Medical Center, Oak Lawn, IL, USA; Heart Care Centers of Illinois, Palos Park, IL, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Yong', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Ruiz', 'Affiliation': 'Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Newark Beth Israel Medical Center, Newark, NY, USA.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, Washington, DC, USA.'}, {'ForeName': 'Mamoo', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Jilaihawi', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Sung-Han', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Augusto D', 'Initials': 'AD', 'LastName': 'Pichard', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Fontana', 'Affiliation': 'Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31358-1']
1271,32604401,Using prefrontal transcranial direct current stimulation (tDCS) to enhance proactive cognitive control in schizophrenia.,"The goal of this study was to use transcranial direct current stimulation (tDCS) to examine the role of the prefrontal cortex (PFC) in neural oscillatory activity associated with proactive cognitive control in schizophrenia. To do so, we tested the impact of PFC-targeted tDCS on behavioral and electrophysiological markers of proactive cognitive control engagement in individuals with schizophrenia. Using a within-participants, double-blinded, sham-controlled crossover design, we recorded EEG while participants with schizophrenia completed a proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20 min of active prefrontal stimulation at 2 mA or sham stimulation. We hypothesized that active stimulation would enhance proactive cognitive control, leading to changes in behavioral performance on the DPX task and in activity in the gamma frequency band during key periods of the task designed to tax proactive cognitive control. The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control. These findings, considered alongside our previous work in healthy adults, provides novel support for the role gamma oscillations in proactive cognitive control and they suggest that frontal tDCS may be a promising approach to enhance proactive cognitive control in schizophrenia.",2020,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","['healthy adults', 'schizophrenia', 'individuals with schizophrenia', 'participants with schizophrenia completed a']","['transcranial direct current stimulation (tDCS', 'proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20\u2009min of active prefrontal stimulation at 2\u2009mA or sham stimulation', 'PFC-targeted tDCS', 'prefrontal transcranial direct current stimulation (tDCS']",['pattern of error rates and increases in EEG gamma power'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0402734,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Boudewyn', 'Affiliation': 'University of California, Santa Cruz, CA, USA. mboudewyn@ucsc.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scangos', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Charan', 'Initials': 'C', 'LastName': 'Ranganath', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'University of California, Davis, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0750-8']
1272,32614875,Participation in interventions and recommended follow-up for non-attendees in cervical cancer screening -taking the women's own preferred test method into account-A Swedish randomised controlled trial.,"BACKGROUND


Cervical cancer is a highly preventable disease. To not attend an organized cervical cancer screening program increases the risk for cervical dysplasia and cervical cancer. The aim was to investigate the participation rate in three different intervention groups for non- attendees in the Swedish national program for cervical screening. The participation in the recommended follow up, and the histology found were also examined.
METHOD


Population-based randomized control trial. It included10,614 women that had not participated in the cervical cancer screening programme during the last six years (ages 30-49) and the last eight years (ages 50-64) were randomised 1:1:1(telephone call from a midwife (offering the choice between a visit for a pap smear or an HPV self-sampling test); an HPV self-sampling test only; or the routine procedure with a yearly invitation).
RESULTS


In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (p<0.001) for telephone, HPV self-test and control groups respectively. In the by protocol analysis including women that answered the phone call the participation rates were 31.7% (N = 565/1784) vs 26.1% (N = 788/3002) and 7.0% (N = 250/3538) (p<0.001) for telephone, HPV self-test and control groups. The corresponding results in the by protocol analysis including women that did not answer the phone call was 19.7% (N = 565/2870) vs 26.1% (N = 788/3002) and 7.0% (N = 250/3538) (p< 0.001). The majority of the women 63,4% (1131/1784) who answered the telephone wanted to participate either by booking a visit for pap smear (38,5%) or to be sent a HPV self- sampling test (24,9%) (p<0.001). Women who chose an HPV self-test were older and gave anxiety/ fear as a reason to decline participation, and they were also less likely to participate in the follow-up if found to be HPV-positive compared to the women who chose a Pap smear. The attendance to the recommended follow-up after abnormality was in total 87%. The non-attendees had a three or eight times higher risk of having a cytology result of HSIL or suspected SCC respectively, in the index sample compared to women screened as recommended (OR 3.3 CI 95% 1.9-5.2, OR 8.6 CI 1.6-30). A total of ten SCC and one adenocarcinoma were found in the histopathology results from the non-attendee group with a study intervention, while there was only one SCC in the non-attendee group without any study intervention (p = 0.02, OR 8.1 CI 95% 1.2-350).
CONCLUSIONS


Our study suggests, according to intention to treat analysis, that the best intervention to get as many non-attendees as possible to participate is to send an HPV self-sampling test together with an invitation letter. Almost 90% of women in the study with an abnormal index sample attended follow-up. This is high enough to indicate that interventions to increase the participation among non-attendees are meaningful.
REGISTRY


International Standard Randomised Controlled Trial Number (ISRCTN) Registration number ISRCTN78719765.",2020,In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (,"['It included10,614 women that had not participated in the cervical cancer screening programme during the last six years (ages 30-49) and the last eight years (ages 50-64', 'non- attendees in the Swedish national program for cervical screening']","['1:1:1(telephone call from a midwife (offering the choice between a visit for a pap smear or an HPV self-sampling test); an HPV self-sampling test only; or the routine procedure with a yearly invitation', 'organized cervical cancer screening program']","['participation rates', 'participation rate', 'cervical dysplasia and cervical cancer']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1298805', 'cui_str': 'Routine procedure'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007868', 'cui_str': 'Dysplasia of cervix'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",10.0,0.0285619,In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lilliecreutz', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Anna-Clara', 'Initials': 'AC', 'LastName': 'Spetz Holm', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}]",PloS one,['10.1371/journal.pone.0235202']
1273,32622346,Effect of Lower Blood Pressure Goals on Left Ventricular Structure and Function in Patients With Subclinical Hypertensive Heart Disease.,"BACKGROUND


Subclinical hypertensive heart disease (SHHD) is a precursor to heart failure. Blood pressure (BP) reduction is an important component of secondary disease prevention in patients with SHHD. Treating patients with SHHD utilizing a more intensive BP target (120/80 mm Hg), may lead to improved cardiac function but there has been limited study of this, particularly in African Americans (AAs).
METHODS


We conducted a single center, randomized controlled trial where subjects with uncontrolled, asymptomatic hypertension, and SHHD not managed by a primary care physician were randomized to standard (<140/90 mm Hg) or intensive (<120/80 mm Hg) BP therapy groups with quarterly follow-up for 12 months. The primary outcome was the differences of BP reduction between these 2 groups and the secondary outcome was the improvement in echocardiographic measures at 12 months.
RESULTS


Patients (95% AAs, 65% male, mean age 49.4) were randomized to the standard (n = 65) or the intensive (n = 58) BP therapy groups. Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg, respectively) (P < 0.05), no significant differences were noted between intention-to-treat groups (P = 0.33) or the proportion with resolution of SHHD (P = 0.31). However, on post hoc analysis, achievement of a sBP <130 mm Hg was associated with significant reduction in indexed left ventricular mass (-6.91 gm/m2.7; P = 0.008) which remained significant on mixed effect modeling (P = 0.031).
CONCLUSIONS


In post hoc analysis, sBP <130 mm Hg in predominantly AA patients with SHHD was associated with improved cardiac function and reverse remodeling and may help to explain preventative effects of lower BP goals.
CLINICAL TRIALS REGISTRATION


Trial Number NCT00689819.",2020,"Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31).","['subjects with uncontrolled, asymptomatic hypertension, and SHHD not managed by a primary care physician were randomized to standard (<140/90 mm Hg) or intensive (<120/80 mm', 'Treating patients with SHHD utilizing a more intensive BP target (120/80 mm Hg', 'patients with SHHD', 'Hg', 'Patients (95% AAs, 65% male, mean age 49.4', 'Subclinical hypertensive heart disease (SHHD', 'African Americans (AAs']",[],"['cardiac function and reverse remodeling', 'Blood pressure ', 'systolic BP (sBP', 'BP reduction', 'indexed left ventricular mass', 'cardiac function', 'echocardiographic measures']","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0152105', 'cui_str': 'Hypertensive heart disease'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085756', 'cui_str': 'African American'}]",[],"[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.120816,"Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31).","[{'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burla', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, Michigan, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Twiner', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Marinica', 'Affiliation': 'Department of Surgery, Sinai-Grace Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Mahn', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Brody', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ehrman', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Brodsky', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Integrative Biosciences Center, Clinical Research Division, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Samar A', 'Initials': 'SA', 'LastName': 'Nasser', 'Affiliation': 'Department of Clinical Research and Leadership, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Flack', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University, Springfield, Illinois, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa108']
1274,32467299,Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma.,"BACKGROUND


A pilot study of stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2) showed a higher than anticipated objective response rate (ORR) among patients with metastatic melanoma (MM). We performed a prospective randomized study to determine if the ORR of SBRT + IL-2 was greater than IL-2 monotherapy in patients with advanced melanoma.
METHODS


Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible. There was a 1:1 randomization to SBRT + IL-2 or IL-2 monotherapy. Patients received one or two doses of SBRT (20 Gy per fraction) with the last dose administered 3 days before starting the first cycle of IL-2. IL-2 (600,000 IU per kg via intravenous bolus infusion) was given every 8 hours for a maximum of 14 doses with a second cycle after a 2-week rest. Responding patients received up to six IL-2 cycles. Patients assigned to IL-2 monotherapy who exhibited progression of melanoma after cycle 2 were allowed to crossover and receive SBRT and additional IL-2. Response Evaluation Criteria in Solid Tumors 1.1 criteria were applied to non-irradiated lesions for response assessment.
RESULTS


44 patients were included in the analysis. The ORR in the SBRT + IL-2 group was 54%: 21% complete response (CR), 33% partial response (PR), 21% stable disease (SD) and 25% progressive disease (PD). The ORR in patients receiving IL-2 monotherapy was 35%: 15% CR, 20% PR, 25% SD and 40% PD. Seven patients assigned to IL-2 subsequently received SBRT + IL-2. One CR and two PRs were observed in the crossover group. There was no difference in progression-free or overall survival (OS). At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group. The disease control rate (DCR) was higher in the SBRT + IL-2 group (75% vs 60%, p=0.34).
CONCLUSIONS


SBRT + IL-2 induced more objective responses with a higher DCR compared to IL-2 monotherapy in MM. IL-2 monotherapy resulted in a significantly higher ORR than anticipated. Some patients in the crossover group also achieved objective responses.
TRIAL REGISTRATION NUMBER


NCT01416831.",2020,At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group.,"['patients with advanced melanoma', 'patients with metastatic melanoma (MM', '44 patients were included in the analysis', 'Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible', 'patients with metastatic melanoma']","['IL-2', 'monotherapy', 'IL-2 monotherapy', 'SBRT + IL-2', 'SBRT', 'stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2', 'stereotactic body radiotherapy and interleukin-2 versus interleukin-2']","['objective response rate (ORR', 'progression-free or overall survival (OS', 'ORR', 'objective responses', 'disease control rate (DCR', 'ORR of SBRT + IL-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}]",44.0,0.306046,At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group.,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Curti', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA brendan.curti@providence.org.'}, {'ForeName': 'Marka', 'Initials': 'M', 'LastName': 'Crittenden', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Seung', 'Affiliation': 'Division of Radiation Oncology, The Oregon Clinic, Portland, Oregon, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Fountain', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Payne', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'ShuChing', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Medical Data Research Center, Providence St Joseph Health, Portland, Oregon, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Fleser', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Malkasian', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Lyn B', 'Initials': 'LB', 'LastName': 'Dobrunick', 'Affiliation': 'Providence Cancer Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Urba', 'Affiliation': 'Providence Cancer Institute, Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000773']
1275,32469304,Pharmacodynamic evaluation of L-carnitine and piracetam in muscle injury induced by the chronic use of simvastatin.,"OBJECTIVES


To evaluate the effect of L-carnitine and piracetam on the muscle injury induced by simvastatin in healthy male subjects during the therapy with oral doses of 10 mL of a solution containing L-carnitine 100 mg/mL + piracetam 80 mg/mL (test group) or placebo (control group) and 40 mg simvastatin once a day during 35 consecutive days. The effect of L-carnitine and piracetam in the reduction of myopathic symptomatology caused by exercise, as well as safety and tolerability were also evaluated.
MATERIALS AND METHODS


This study was performed on two different occasions, of which 42 subjects were investigated on occasion 1 and 19 on occasion 2. Discomfort or pain was evaluated according to modified Borg scale. Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), creatine kinase (CK), and lactic dehydrogenase (LDH) were evaluated on the 4 th , 11 th , 18 th , 25 th , and 32 nd  day after therapy, and before and until 4 hours after an exercise test performed on a treadmill on day 36.
RESULTS


A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295). The serum levels of AST, ALT, and LDH were statistically different, with lower values in the test group compared to the control group.
CONCLUSION


Concomitant use of L-carnitine and piracetam might have a muscle-protective effect and protection against simvastatin-induced myalgia. Furthermore, the formulation was safe and well tolerated by the subjects investigated in this trial.",2020,"A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295).","['42 subjects were investigated on occasion 1 and 19 on occasion 2', 'healthy male subjects during the therapy with oral doses of 10 mL of a']","['L-carnitine and piracetam', 'simvastatin', 'solution containing L-carnitine 100 mg/mL + piracetam 80 mg/mL (test group) or placebo (control group) and 40 mg simvastatin']","['Discomfort or pain', 'safety and tolerability', 'serum levels of AST, ALT, and LDH', 'safe and well tolerated', 'pain or discomfort', 'Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transferase (γ-GT), creatine kinase (CK), and lactic dehydrogenase (LDH']","[{'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0031977', 'cui_str': 'Piracetam'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0678107', 'cui_str': 'Glutamyl transferase'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",42.0,0.0436808,"A higher incidence of pain or discomfort was observed in the control group than in the test group, mainly in occasion 1 (29% vs. 62% experienced pain or discomfort in any period, p = 0.0295).","[{'ForeName': 'Renan Marcel Bonilha', 'Initials': 'RMB', 'LastName': 'Dezena', 'Affiliation': ''}, {'ForeName': 'Natalícia de Jesus', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Campos', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Ilha', 'Affiliation': ''}, {'ForeName': 'Ronilson A', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': ''}, {'ForeName': 'Paulo César Pires', 'Initials': 'PCP', 'LastName': 'Rosa', 'Affiliation': ''}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203496']
1276,32464420,Whole egg consumption increases plasma choline and betaine without affecting TMAO levels or gut microbiome in overweight postmenopausal women.,"As a crucial part of the symbiotic system, the gut microbiome is metabolically connected to many diseases and conditions, including cardiovascular diseases (CVD). Trimethylamine (TMA) is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and is then converted in the liver to Trimethylamine N-oxide (TMAO), which in turn affects hepatic and intestinal lipid metabolism. Circulating TMAO is positively associated with CVD risk. Because eggs are rich in choline, it has been speculated that their consumption may increase plasma TMAO. In this study, we hypothesized that 2 eggs per day increases plasma TMAO level by altering gut microbiome composition in mildly hypercholesterolemic postmenopausal women. In this randomized, cross-over study, 20 overweight, postmenopausal women were given 2 whole eggs and the equivalent amount of yolk-free substitute as breakfast for 4 weeks, in randomized order, with a 4-week washout in between. Fasting blood draws and stool were collected at the beginning and end of each treatment period. Plasma TMAO, choline, betaine and other metabolites were analyzed using LC/MS, while gut microbiome composition was analyzed using 16S amplicon sequencing. Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments. Gut microbiome composition showed large inter-individual variability at baseline and in response to the treatments. The consumption of 2 eggs per day in overweight, postmenopausal mildly hypercholesterolemic women significantly increased plasma choline and betaine, but did not increase plasma TMAO or alter gut microbiome composition.",2020,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","['mildly hypercholesterolemic postmenopausal women', 'overweight postmenopausal women', '20 overweight, postmenopausal women']",['Trimethylamine (TMA'],"['plasma TMAO', 'plasma TMAO level', 'Plasma TMAO, choline, betaine and other metabolites', 'Plasma choline and betaine', 'Fasting blood draws and stool', 'TMAO level', 'plasma choline and betaine', 'plasma TMAO or alter gut microbiome composition']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0077172', 'cui_str': 'trimethylamine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0381708,"Plasma choline and betaine were significantly increased after whole egg but not yolk-free substitute, however TMAO level was not significantly affected by treatments.","[{'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: chhzhu@ucdavis.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sawrey-Kubicek', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: lsawreykubicek@ucdavis.edu.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bardagjy', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: asteve@ucdavis.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Houts', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: hehouts@ucdavis.edu.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: xctang@ucdavis.edu.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Sacchi', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: romisacchi@gmail.com.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Randolph', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: jmrandolph@ucdavis.edu.'}, {'ForeName': 'Francene M', 'Initials': 'FM', 'LastName': 'Steinberg', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: fmsteinberg@ucdavis.edu.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Zivkovic', 'Affiliation': 'Department of Nutrition, University of California, Davis, Davis, CA, USA 95616. Electronic address: amzivkovic@ucdavis.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.04.002']
1277,32473378,Annexin A1 is a Potential Novel Biomarker of Congestion in Acute Heart Failure.,"OBJECTIVES


This study sought to identify the role of annexin A1 (AnxA1) as a congestion marker in acute heart failure (AHF) and to identify its putative role in predicting clinical outcomes.
BACKGROUND


AnxA1 is a protein that inhibits inflammation following ischemia-reperfusion injury in cardiorenal tissues. Because AHF is a state of tissue hypoperfusion, we hypothesized that plasma AnxA1 levels are altered in AHF.
METHODS


In the Renal Optimization Strategies Evaluation (ROSE) trial, patients hospitalized for AHF with kidney injury were randomized to receive dopamine, nesiritide, or placebo for 72 hours in addition to diuresis. In a subanalysis, plasma AnxA1 levels were measured at baseline and at 72 hours in 275 patients. Participants were divided into 3 tertiles based on their baseline AnxA1 levels.
RESULTS


The prevalence of peripheral edema 2+ increased with increasing AnxA1 levels (P < .007). Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (P< .05). Patients with a congestion score of 4 had a mean baseline AnxA1 level 8.63 units higher than those with a congestion score of 0 (P = .03). Patients in tertiles 2 and 3 were twice as likely to experience creatinine elevation as patients in tertile 1 (P = .03). Patients in tertiles 2 and 3 were at a higher risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality (P < .05).
CONCLUSIONS


Among patients hospitalized for AHF with impaired kidney function, elevated AnxA1 levels are associated with worse congestion, higher risk for further creatinine elevation, and higher rates of 60-day morbidity or all-cause mortality and 180-day all-cause mortality.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01132846.",2020,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).",['patients hospitalized for AHF with kidney injury'],"['dopamine, nesiritide, or placebo', 'nAnnexin A1', 'Annexin A1']","['plasma AnxA1 levels', '60-day morbidity', 'Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels', 'risk of 60-day all-cause mortality or heart failure hospitalization and 180-day all-cause mortality', 'experience creatinine elevation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103403', 'cui_str': 'Annexin A1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C1313407', 'cui_str': 'HAVCR1 protein, human'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",,0.20289,"Cystatin C, blood urea nitrogen, and kidney injury molecule-1 plasma levels were higher among participants in tertile 3 vs tertiles 1 or 2 (p < 0.05).","[{'ForeName': 'Fadi W', 'Initials': 'FW', 'LastName': 'Adel', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Rikhi', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Siu-Hin', 'Initials': 'SH', 'LastName': 'Wan', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Seethalakshmi R', 'Initials': 'SR', 'LastName': 'Iyer', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Cardiorenal Research Laboratory, Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota. Electronic address: Chen.Horng@mayo.edu.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.05.012']
1278,32475359,"Glucose control upon waking is unaffected by hourly sleep fragmentation during the night, but is impaired by morning caffeinated coffee.","Morning coffee is a common remedy following disrupted sleep, yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults. Remarkably, the combined effects of sleep fragmentation and coffee on glucose control upon waking per se have never been investigated. In a randomised crossover design, twenty-nine adults (mean age: 21 (sd 1) years, BMI: 24·4 (sd 3·3) kg/m2) underwent three oral glucose tolerance tests (OGTT). One following a habitual night of sleep (Control; in bed, lights-off trying to sleep approximately 23.00-07.00 hours), the others following a night of sleep fragmentation (as Control but waking hourly for 5 min), with and without morning coffee approximately 1 h after waking (approximately 300 mg caffeine as black coffee 30 min prior to OGTT). Individualised peak plasma glucose and insulin concentrations were unaffected by sleep quality but were higher following coffee consumption (mean (normalised CI) for Control, Fragmented and Fragmented + Coffee, respectively; glucose: 8·20 (normalised CI 7·93, 8·47) mmol/l v. 8·23 (normalised CI 7·96, 8·50) mmol/l v. 8·96 (normalised CI 8·70, 9·22) mmol/l; insulin: 265 (normalised CI 247, 283) pmol/l; and 235 (normalised CI 218, 253) pmol/l; and 310 (normalised CI 284, 337) pmol/l). Likewise, incremental AUC for plasma glucose was higher in the Fragmented + Coffee trial compared with Fragmented. Whilst sleep fragmentation did not alter glycaemic or insulinaemic responses to morning glucose ingestion, if a strong caffeinated coffee is consumed, then a reduction in glucose tolerance can be expected.",2020,Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults.,"['healthy adults', '29 adults (Mean ± SD; age: 21 ± 1 years, BMI: 24.4 ± 3.3 kg·m-2) underwent three']","['habitual night of sleep (Control; in bed, lights-off trying to sleep ~2300-0700 h) the others following a night of sleep fragmentation', 'oral glucose tolerance tests (OGTT', 'Fragmented+Coffee']","['glucose tolerance', 'Likewise, iAUC for plasma glucose']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",29.0,0.0411912,Morning coffee is a common remedy following disrupted sleep yet each factor can independently impair glucose tolerance and insulin sensitivity in healthy adults.,"[{'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Walhin', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Perkin', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Centre for Nutrition, Exercise & Metabolism, Department for Health, University of Bath, BathBA2 7AY, UK.'}]",The British journal of nutrition,['10.1017/S0007114520001865']
1279,32482970,Efficacy of Guanfacine Extended Release in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder.,"OBJECTIVE


To assess the efficacy of the non-stimulant guanfacine extended release (GXR) on attention-deficit/hyperactivity disorder (ADHD) symptoms in children and adolescents, with and without comorbid oppositional defiant disorder (ODD).
METHODS


Data were derived from 4 phase 3, randomized, placebo-controlled trials of dose-optimized GXR monotherapy, in which at least 10% of participants had a diagnosis of comorbid ODD. SPD503-312 and SPD503-316 were 10- to 13-week studies of GXR (1-7 mg/d). SPD503-314 and SPD503-307 were 8-week studies of GXR (1-4 mg/d). Efficacy was assessed using the ADHD Rating Scale IV (ADHD-RS-IV) total scores.
RESULTS


In total, 1,084 participants were included (SPD503-312 and SPD503-316, n = 537; SPD503-314, n = 333; and SPD503-307, n = 214). GXR was associated with significant improvements in ADHD core symptoms at endpoint in participants with and without ODD (p < 0.01 in all studies). Placebo-adjusted least-squares mean (95% confidence interval) changes from baseline to endpoint in the ADHD-RS-IV total scores in participants with and without ODD were -8.6 (-14.4, -2.8) and -7.3 (-9.5, -5.0) in the pooled data from SPD503-312 and SPD503-316, -12.6 (-19.6, -5.7) and -8.7 (-11.8, -5.5) in SPD503-314, and -12.7 (-17.3, -8.1) and -11.8 (-19.3, -4.4) in SPD503-307, respectively. The corresponding effect sizes were 0.688 and 0.598 in SPD503-312 and SPD503-316, 0.876 and 0.729 in SPD503-314, and 0.962 and 0.842 in SPD503-307.
CONCLUSION


The findings demonstrate the efficacy of GXR for treating ADHD in children and adolescents with comorbid ODD.",2020,GXR was associated with significant improvements in ADHD core symptoms at endpoint in participants with and without ODD (p < 0.01 in all studies).,"['children and adolescents with comorbid ODD', 'Children and Adolescents with Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder', 'Data were derived from 4 phase 3, randomized', 'children and adolescents, with and without comorbid oppositional defiant disorder (ODD', '1,084 participants were included (SPD503-312 and SPD503-316, n = 537; SPD503-314, n = 333; and SPD503-307, n = 214']","['Placebo', 'GXR monotherapy', 'Guanfacine', 'GXR', 'guanfacine extended release (GXR', 'placebo']","['Efficacy', 'ADHD-RS-IV total scores', 'ADHD core symptoms', 'ADHD Rating Scale IV (ADHD-RS-IV) total scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1084.0,0.181548,GXR was associated with significant improvements in ADHD core symptoms at endpoint in participants with and without ODD (p < 0.01 in all studies).,"[{'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Newcorn', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Huss', 'Affiliation': 'Child and Adolescent Psychiatry, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Connor', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry, University of Connecticut School of Medicine, Farmington, CT.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Hervás', 'Affiliation': 'Psiquiatría Infantil y Juvenil, University Hospital Mútua de Terrassa, Barcelona, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Werner-Kiechle', 'Affiliation': 'Shire, Zug, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Shire, Lexington, MA.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000822']
1280,32491006,Controlled Study of Central Hemodynamic Changes in Inspiratory Exercise with Different Loads in Heart Failure.,"Background Inspiratory muscle weakness contributes to exercise intolerance and decreased quality of life in patients with heart failure. Studies with inspiratory muscle training show improvement in inspiratory muscle strength, functional capacity and quality of life. However, little is known about the central hemodynamic response (CHR) during inspiratory exercise (IE). Objective To evaluate CHR in a single IE session with different loads (placebo, 30% and 60%) in heart failure. Methods Randomized placebo-controlled clinical trial in patients with heart failure with reduced ejection fraction, functional class II and III. Twenty patients aged 65 ± 11 years completed a single session of inspiratory exercise, in 3 cycles of 15 minutes, with a 1-hour washout, involving loads of 30% (C30), 60% (C60) and placebo, using a linear load resistor (PowerBreathe Light). The noninvasive hemodynamic study was performed by cardiothoracic bioimpedance (Niccomo™ CardioScreen®). Statistical analysis was performed with Student's t-test and Pearson's correlation, and P≤0.05 was considered significant. Results An increase in heart rate (HR) was observed with C30 (64 ± 15 vs 69 ± 15 bpm; p = 0.005) and C60 (67 ± 14 vs 73 ± 14 bpm, p = 0.002). A decrease was observed in systolic volume (SV) with C30 (73 ± 26 vs 64 ± 20 ml; p = 0.004). Cardiac output (CO), on its turn, increased only with C60 (4.6 ± 1.5 vs 5.3 ± 1.7 l/min; p = -0.001). Conclusion When using the 60% load, in a single IE session, changes in CHR were observed. HR and CD increased, as did the Borg scales and subjective sensation of dyspnea. The 30% load reduced the SV. (Arq Bras Cardiol. 2020; 114(4):656-663).",2020,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","['patients with heart failure with reduced ejection fraction, functional class II and III', 'patients with heart failure', 'Twenty patients aged 65 ± 11 years completed a', 'Inspiratory Exercise with Different Loads in Heart Failure']","['placebo', 'single session of inspiratory exercise', 'inspiratory muscle training']","['quality of life', 'CHR', 'inspiratory muscle strength, functional capacity and quality of life', 'systolic volume (SV', 'HR and CD', 'heart failure', 'heart rate (HR', 'SV', 'subjective sensation of dyspnea', 'Cardiac output (CO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",,0.0580409,"HR and CD increased, as did the Borg scales and subjective sensation of dyspnea.","[{'ForeName': 'Luana de Decco', 'Initials': 'LD', 'LastName': 'Marchese', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Chermont', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Warol', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Lucia Brandão de', 'Initials': 'LB', 'LastName': 'Oliveira', 'Affiliation': 'Clínica de Insuficiência Cardíaca, Centro Universitário Serra dos Órgãos, Teresópolis, RJ, Brasil.'}, {'ForeName': 'Sabrina Bernardez', 'Initials': 'SB', 'LastName': 'Pereira', 'Affiliation': 'Hospital do Coração, São Paulo, SP – Brazil'}, {'ForeName': 'Mônica', 'Initials': 'M', 'LastName': 'Quintão', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}, {'ForeName': 'Evandro Tinoco', 'Initials': 'ET', 'LastName': 'Mesquita', 'Affiliation': 'Universidade Federal Fluminense, Niterói, RJ, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180375']
1281,32487507,Reducing the Number of Opioids Consumed After Discharge Following Elective Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


To reduce opioids consumed after discharge from hospital after elective cesarean delivery by 50%.
METHODS


This was a 2-week parallel group non-blinded randomized controlled trial at Mount Sinai Hospital. Eligible women undergoing elective cesarean delivery were assigned by random number generation to receive the hospital's standard post-cesarean opioid prescription of 20 1-mg hydromorphone tablets or a prescription for 10 1-mg hydromorphone tablets if opioids were required in hospital or no hydromorphone if no opioids were required in hospital. Patients completed a study questionnaire at 2 weeks postpartum detailing outcome measures. The primary outcome was the amount of opioid consumed after discharge.
RESULTS


A total of 40 women were randomly assigned to a study group and 37 were included in the data analysis; 17 patients were in the control group and 20 in the experimental group. The median number of tablets consumed did not differ between groups (P = 0.407). The median number of excess tablets prescribed was 20 (range 2-18) in the control group and 0 (range 0-10) in the experimental group (P < 0.001).
CONCLUSIONS


The current standard discharge practice of giving 20 1-mg hydromorphone tablets to all patients post-discharge after cesarean delivery contributes to a substantial excess of opioids in the community. These opioids can be diverted for unintended or accidental usage, and exacerbate larger societal issues of opioid misuse and addiction. Decreasing the number of opioids prescribed with tailored discharge prescriptions based on in-hospital opioid use provides nearly all patients with adequate pain control.",2020,The median number of tablets consumed did not differ between groups (P = 0.407).,"['Eligible women undergoing elective cesarean delivery', 'A total of 40 women were randomly assigned to a study group and 37 were included in the data analysis; 17 patients were in the control group and 20 in the experimental group']","['hydromorphone tablets if opioids were required in hospital or no hydromorphone if no opioids', 'hydromorphone tablets']","['median number of excess tablets', 'median number of tablets', 'amount of opioid consumed after discharge', 'Number of Opioids Consumed']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",40.0,0.373934,The median number of tablets consumed did not differ between groups (P = 0.407).,"[{'ForeName': 'Shira', 'Initials': 'S', 'LastName': 'Gold', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Figueiro-Filho', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selk', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto, Toronto, ON; Mount Sinai Hospital, Department of Obstetrics and Gynecology, Toronto, ON. Electronic address: amanda.selk@utoronto.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.02.123']
1282,32589129,"Prospective partially randomized comparison of clopidogrel loading versus maintenance dosing to prevent periprocedural myocardial infarction after stenting for stable angina pectoris: Results from the ""Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients (MECCA)"" study.","WHAT IS KNOWN AND OBJECTIVE


Pre-treatment of clopidogrel 600 mg is better than 300 mg loading for reducing periprocedural myocardial infarction (PMI). We aimed to evaluate pre-treatment methods for preventing PMI among patients undergoing conventional coronary angiography (CAG) for stable angina pectoris.
MATERIALS AND METHODS


The study analyzed 402 patients who underwent percutaneous coronary intervention (PCI) during 2010 - 2011 at three Korean hospitals. Clopidogrel-naïve patients received routine maintenance therapy (75 mg/day for ≥ 5 days) and were randomly assigned to a 300-mg reload (RL) or only the maintenance dose (MD). Patients who received a loading dose (LD; 600 mg at 2 - 24 hours before the procedure) were entered into a non-randomized group.
RESULTS


After excluding patients who showed an abnormal creatinine kinase myocardial band (CK-MB) level, the study included 233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group. The LD group had a significantly higher rate of PMI (LD: 21, RL: 3, MD: 0 cases; p = 0.007) and a significant increase in the mean CK-MB levels after 8 hours (p = 0.016) and 24 h (p = 0.01). However, there was no difference in PMI between the RL and MD groups. Furthermore, no significant differences between the three groups were observed in the P2Y12 reaction unit (PRU) values (p = 0.57). Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days.
WHAT IS NEW AND CONCLUSION


Clopidogrel maintenance is better than 600-mg loading for preventing PMI, and the RL protocol did not further prevent PMI.",2020,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days.
","['233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group', 'patients undergoing', '402 patients who underwent percutaneous coronary intervention (PCI) during 2010\xa0-\xa02011 at three Korean hospitals', 'stable angina pectoris']","['clopidogrel loading', 'conventional coronary angiography (CAG', '300-mg reload (RL) or only the maintenance dose (MD', 'clopidogrel', 'Clopidogrel-naïve patients received routine maintenance therapy', 'Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram']","['rate of PMI', 'rate of moderate-to-severe GUSTO bleeding', 'periprocedural myocardial infarction', 'P2Y12 reaction unit (PRU) values', 'periprocedural myocardial infarction (PMI', 'mean CK-MB levels', 'PMI', 'abnormal creatinine kinase myocardial band (CK-MB) level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0740471', 'cui_str': 'Creatinine abnormal NOS'}]",233.0,0.0456417,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days.
","[{'ForeName': 'Jae Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Je Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Kyung Joo', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Do-Sun', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203644']
1283,32589455,Virtual Reality Aids Game Navigation: Evidence from the Hypertext Lostness Measure.,"Instead of traditional free movement, node-based movement can be used in virtual reality (VR) games. In node-based movement systems, players navigate by jumping to set locations. Node-based movement is similar to hypertext navigation. We show that the hypertext lostness measure can be used as a game analytic to evaluate navigational efficiency. In a randomized controlled trial with 25 adolescent participants, an immersive desktop game environment and a VR game environment were compared on the transmission of in-game educational content and navigational efficiency. Results show that the hypertext lostness measure is also valuable outside its original hypertext domain: in VR. VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency. We conclude (a) the hypertext lostness measure is also valuable for node-based VR games and (b) VR games add to spatial learning, even when compared with already immersive desktop games.",2020,"VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency.",['25 adolescent participants'],['immersive desktop game environment and a VR game environment'],"[""players' spatial knowledge and navigational efficiency"", ""players' retention of factual knowledge""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",25.0,0.0146821,"VR did not improve players' retention of factual knowledge, but did significantly improve players' spatial knowledge and navigational efficiency.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ferguson', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Egon L', 'Initials': 'EL', 'LastName': 'van den Broek', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Herre', 'Initials': 'H', 'LastName': 'van Oostendorp', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'de Redelijkheid', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Giezeman', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Utrecht, Netherlands.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2019.0435']
1284,32591267,The Effect of Motivational Interviewing on Women with Overweight and Obesity Before Conception.,"OBJECTIVE


To investigate the efficacy of motivational interviewing (MI) to elicit change in eating and physical activity behaviors in women with overweight and obesity before conception.
DESIGN


A randomized controlled trial was conducted. The participants were randomly divided into intervention and comparison groups. Data were gathered using the Three-Factor Eating Questionnaire Revised 18-item version (TFEQ-R18), International Physical Activity Questionnaire (IPAQ), and Stages of Change checklist.
SETTING


Primary health centers of Tabriz, Iran.
PARTICIPANTS


The participants were 70 women with overweight or obesity, aged 18-35 years, who were referred for preconception care.
INTERVENTION(S)


The intervention group received 6 MI sessions, and the comparison group received routine preconception care.
MAIN OUTCOME MEASURE(S)


Variables of primary outcomes were eating behavior measures and physical activity levels 8 weeks after intervention.
ANALYSIS


Independent t test, ANCOVA, Fisher exact test, Mann-Whitney U test, and Wilcoxon test were used.
RESULTS


The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively). After the intervention, the mean score of cognitive restraint in the intervention group was higher than in the comparison group (adjusted mean difference, 16.9; 95% CI, 10.8 to 23.0; P < .001), whereas there were no significant differences between the 2 groups in terms of emotional and uncontrolled eating (P = .33 and P = .25, respectively).
CONCLUSIONS AND IMPLICATIONS


The MI had a positive effect on physical activity and eating behavior change, except for uncontrolled and emotional eating. Future studies to examine differences between overweight and women with obesity and within other populations is warranted.",2020,"The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively).","['women with overweight and obesity before conception', 'Primary health centers of Tabriz, Iran', 'participants were 70 women with overweight or obesity, aged 18-35 years, who were referred for preconception care', 'Women with Overweight and Obesity Before Conception']","['6 MI sessions, and the comparison group received routine preconception care', 'motivational interviewing (MI', 'Motivational Interviewing']","['mean score of cognitive restraint', 'Factor Eating Questionnaire Revised 18-item version (TFEQ-R18), International Physical Activity Questionnaire (IPAQ), and Stages of Change checklist', 'emotional and uncontrolled eating', 'physical activity', 'eating and physical activity behaviors', 'eating behavior measures and physical activity levels', 'physical activity and eating behavior change']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0085284', 'cui_str': 'Preconception care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",70.0,0.0661103,"The MI had a positive effect on physical activity in the moderate and vigorous levels in the intervention group (P = .01, P = .02, respectively).","[{'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Nourizadeh', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samar', 'Initials': 'S', 'LastName': 'Azami', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Azizeh', 'Initials': 'A', 'LastName': 'Farshbaf-Khalili', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: b.mehrabi62@gmail.com.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.04.219']
1285,32592897,In-Hospital Management of Sleep Apnea During Heart Failure Hospitalization: A Randomized Controlled Trial.,"BACKGROUND


Obstructive sleep apnea (OSA) is associated with increased mortality and readmissions in patients with heart failure (HF). The effect of in-hospital diagnosis and treatment of OSA during decompensated HF episodes remains unknown.
METHODS AND RESULTS


A single-site, randomized, controlled trial of hospitalized patients with decompensated HF (n = 150) who were diagnosed with OSA during the hospitalization was undertaken. All participants received guideline-directed therapy for HF decompensation. Participants were randomized to an intervention arm which received positive airway pressure (PAP) therapy during the hospitalization (n = 75) and a control arm (n = 75). The primary outcome was discharge left ventricular ejection fraction (LVEF). The LVEF changed in the PAP arm from 25.5 ± 10.4 at baseline to 27.3 ± 11.9 at discharge. In the control group, LVEF was 27.3 ± 11.7 at baseline and 28.8 ± 10.5 at conclusion. There was no significant effect on LVEF of in-hospital PAP compared with controls (P = .84) in the intention-to-treat analysis. The on-treatment analysis in the intervention arm showed a significant increase in LVEF in participants who used PAP for ≥3 hours per night (n = 36, 48%) compared with those who used it less (P = .01). There was a dose effect with higher hours of use associated with more improvement in LVEF. Follow-up of readmissions at 6 months after discharge revealed a >60% decrease in readmissions for patients who used PAP ≥3 h/night compared with those who used it <3 h/night (P < .02) and compared with controls (P < .04).
CONCLUSIONS


In-hospital treatment with PAP was safe but did not significantly improve discharge LVEF in patients with decompensated HF and newly diagnosed OSA. An exploratory analysis showed that adequate use of PAP was associated with higher discharge LVEF and decreased 6 months readmissions.",2020,There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis.,"['hospitalized patients with decompensated HF (n=150) who were diagnosed with OSA during the hospitalization', 'patients with decompensated HF and newly diagnosed OSA', 'patients with heart failure (HF', 'Obstructive sleep apnea (OSA']","['positive airway pressure (PAP) therapy', 'LVEF', 'guideline directed therapy', 'OSA']","['LVEF', 'discharge LVEF', 'discharge left ventricular ejection fraction (LVEF', 'readmissions', 'LVEF of in-hospital PAP']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.0782909,There was no significant effect on LVEF of in-hospital PAP compared to control (p = 0.84) in the intention to treat analysis.,"[{'ForeName': 'Rami N', 'Initials': 'RN', 'LastName': 'Khayat', 'Affiliation': 'The UCI Sleep Disorders Center and the Division of Pulmonary and Critical Care, University of California at Irvine, Irvine, California; The Sleep Heart Program at the Ohio State University, Columbus, Ohio. Electronic address: rnkhayat@gmail.com.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': 'Bethesda North Hospital, Cincinnati, Ohio; Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio; University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Porter', 'Affiliation': 'The Center for Biostatistics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sow', 'Affiliation': 'The Sleep Heart Program at the Ohio State University, Columbus, Ohio; The Center for Clinical and Translational Science, The Ohio State University Columbus, Ohio.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Randerath', 'Affiliation': 'Bethanien Hospital, Institute of Pneumology at the University of Cologne, Solingen, Germany.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jarjoura', 'Affiliation': 'The Sleep Heart Program at the Ohio State University, Columbus, Ohio; Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio; The Center for Biostatistics, The Ohio State University, Columbus, Ohio.'}]",Journal of cardiac failure,['10.1016/j.cardfail.2020.06.007']
1286,32593960,Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors.,"BACKGROUND


Increasing evidence for contribution of hemostasis components in multiple sclerosis (MS) has been reported. Hemostasis protein inhibitors display key regulatory roles, extending to regulation of innate immune response and inflammation, and promotion of blood-brain barrier integrity. Whereas the effects on hemostasis of exercise and rehabilitation strategies have been extensively investigated, relationships between MS rehabilitation strategies and hemostasis have not been previously reported.
OBJECTIVES


To investigate in MS patients the association between outcomes of rehabilitative exercise and plasma levels of selected hemostasis inhibitors.
METHODS


Sixty-one severely disabled progressive-MS (P-MS) patients were randomized in the RAGTIME trial to receive 12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT). Outcome parameters were: timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29). Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3). Descriptive analysis, trend analysis, Spearman's rank and Pearson's correlations, and multiple regression models were used.
RESULTS


Rehabilitative exercises moderately modified plasma protein concentrations. A significant trend to increase was observed for PS (p=0.015) and TFPI (p=0.047) in the whole population, and for PS (p=0.011) in the CT group. Correlation between TFPI and sTM levels was detectable at all time points in the whole P-MS patients and in RAGT group. The correlation between TFPI and PS, present at T0, was lost during the rehabilitation, and recovered at T3 in the whole population and CT group. During rehabilitation, positive variations of TFPI were inversely related with changes in 6MWT in the whole population (r=-0.309, p=0.021), and in the RAGT group (r=-0.51, p=0.004). In all P-MS, PS T0 levels were associated (r=0.379, p=0.004) with increased gait speed, which in the RAGT group was associated both with PS T0 (r=0.378, p=0.040), and sTM T0 (r=0.453, p=0.012). Accordingly, in the regression model including age, sex and EDSS and the stepwise enter of PS T0, higher PS T0 levels predicted increased gait speed in all P-MS (F=3.4, p=0.016) The regression model in the RAGT group indicated that higher PS and sTM T0 levels were both predictors of increased gait speed (F=5.7, p=0.001).
CONCLUSIONS


Plasma levels of coagulation inhibitors were related to variations of outcome measurements after high-intensity walking rehabilitation programs. Patients with decreased TFPI levels from T0 to T2 displayed the most significant functional recovery following rehabilitation, and particularly after RAGT. Higher baseline total PS levels were associated with favorable outcomes of rehabilitation therapies in MS. These novel findings, which suggest that plasma levels of hemostasis inhibitors might have implication for rehabilitative therapy options in MS, warrant further investigation.",2020,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","['Sixty-one severely disabled progressive-MS (P-MS) patients', 'multiple sclerosis patients undergoing rehabilitation programs', 'multiple sclerosis (MS']",['12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT'],"['PS T0 levels', 'TFPI levels', 'Higher baseline total PS levels', 'gait speed', 'Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI', 'timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29', 'plasma protein concentrations', 'PS', 'TFPI', 'PS and sTM T0 levels', 'TFPI and sTM levels', 'multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1168441', 'cui_str': 'Protein S total'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",61.0,0.0295241,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ziliotto', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara; School of Medicine and Surgery, University of Milano - Bicocca, Monza, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy; Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Baroni', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tisato', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Carantoni', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Secchiero', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Marchetti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bernardi', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara. Electronic address: ber@unife.it.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102319']
1287,32609230,Effect of CPP-ACP on remineralization of artificial caries-like lesion: an in situ study.,"The purpose of this double-blind, randomized, crossover in situ study is to compare remineralization of preformed enamel lesions by casein phosphopeptide-stabilized amorphous calcium phosphate (CPP-ACP) and fluoride dentifrice products. During each of four 10-day experimental legs, 10 participants wore intraoral removable palatal acrylic appliances with four human enamel slabs with preformed lesions. A 0.03-mL treatment paste was dripped extraorally onto the enamel blocks once a day for 3 min. The four randomly allocated treatments were as follows: CO- Control: silica dentifrice without fluoride; MP: MI Paste; MPP: MI Paste Plus and FD: Fluoride dentifrice - 1100 ppm F as NaF). Knoop surface hardness (SH) test was performed in three stages (T0 - sound enamel, T1 - after preformed lesion, and T2 - after treatment) and the cross-sectional hardness (CSH) test was performed after treatment using a 50-gram Knoop load for 15 s. Knoop hardness number (KHN) was similar between treatments. %SHr was significantly higher in the MP, FD, and MPP when compared to CO group (Kruskal-Wallis and Mann-Whitney tests, p < 0.05). Harder enamel was found in MP (75 μm) and FD groups at 75 to 175 μm. Treatment with DF, MP, and MPP promoted an increase of 20.27%, 19.24%, and 14.71%, respectively, in Integral Hardness Change (ΔIHC) when compared to CO (p<0.05). Remineralizing agents (MP, MPP, and DF) were able to inhibit demineralization of human enamel subjected to high cariogenic challenge in situ. DF had the greatest preventive potential against the progression of carious lesions.",2020,"Remineralizing agents (MP, MPP, and DF) were able to inhibit demineralization of human enamel subjected to high cariogenic challenge in situ.","['artificial caries-like lesion', '10 participants wore intraoral removable palatal acrylic appliances with four human enamel slabs with preformed lesions']","['CPP-ACP', 'Remineralizing agents (MP, MPP, and DF', 'casein phosphopeptide-stabilized amorphous calcium phosphate (CPP-ACP) and fluoride dentifrice products', 'CO', 'FD', 'Fluoride dentifrice - 1100 ppm F as NaF']","['Integral Hardness Change (ΔIHC', 'Knoop surface hardness (SH) test', 'MP, FD, and MPP']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018600', 'cui_str': 'Hardness Tests'}]",10.0,0.0616156,"Remineralizing agents (MP, MPP, and DF) were able to inhibit demineralization of human enamel subjected to high cariogenic challenge in situ.","[{'ForeName': 'Patrícia Regina Almeida de', 'Initials': 'PRA', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}, {'ForeName': 'Caroliny Mello', 'Initials': 'CM', 'LastName': 'Barboza', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}, {'ForeName': 'Luísa Schubach da Costa', 'Initials': 'LSDC', 'LastName': 'Barreto', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}, {'ForeName': 'Mônica Almeida', 'Initials': 'MA', 'LastName': 'Tostes', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0061']
1288,32609304,Questions on a Randomized Clinical Trial of Stellate Ganglion Block for Patients With Posttraumatic Stress Disorder-Reply.,,2020,,['Patients'],['Stellate Ganglion Block'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}]",[],,0.0384787,,"[{'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Rae Olmsted', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Bradford B', 'Initials': 'BB', 'LastName': 'Walters', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1822']
1289,32609319,Questions on a Randomized Clinical Trial of Stellate Ganglion Block for Patients With Posttraumatic Stress Disorder.,,2020,,['Patients With Posttraumatic Stress Disorder'],['Stellate Ganglion Block'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}]",[],,0.0411613,,"[{'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1815']
1290,32485095,"Differential effects of testosterone on circulating neutrophils, monocytes, and platelets in men: Findings from two trials.","BACKGROUND


Testosterone treatment increases erythrocytes in men, but its effects on leukocyte and platelet counts are unknown and could affect its safety.
OBJECTIVE


To determine whether testosterone affects circulating leukocytes and platelets in men.
METHODS


Secondary analyses of two randomized testosterone trials were performed: the 5α-reductase (5aR) and OPTIMEN trials. In 5aR trial, 102 healthy men, 21-50 years (mean age 38), received a long-acting GnRH agonist, and 50, 125, 300, or 600 mg/week testosterone enanthate (TE) plus placebo or 2.5 mg /  day dutasteride for 20 weeks. In OPTIMEN, 78 functionally limited men, ≥65 years (mean age 72) with protein intake ≤ 0.83 g kg -1   day -1  , were randomized to controlled diets with 0.8 g kg -1   day -1  protein or 1.3 g kg -1   day -1  protein plus placebo or TE (100 mg/week) for 6 months. Changes from baseline in total and differential leukocyte count, and platelet count were evaluated.
RESULTS


In 5aR, testosterone administration was associated with increases in total leukocyte (estimated change from baseline 40, 490, 1230, and 1280 cells/µL, P < .001), neutrophil (65.1, 436.1, 1177.2, and 1192.2 cells/µL, P < .001), monocyte (-20.2, 24.5, 90.6, and 143.9 cells/µL, P < .001), platelet (-7.3, 8.4, 8.7, and 8.9 × 10 3  cells/µL, P = .033), and erythrocyte counts. Testosterone did not affect absolute lymphocyte count. Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77 × 10 3  cells/µL, P vs placebo = 0.004).
CONCLUSIONS


Testosterone administration in men differentially increases neutrophil and monocyte counts. These findings, together with its erythropoietic effects, suggest that testosterone promotes the differentiation of hematopoietic progenitors into the myeloid lineage. These findings have potential mechanistic, therapeutic, and safety implications.",2020,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"['78 functionally-limited men, ≥65 years (mean age 72) with protein intake ≤0.83 g *  kg -1   *  day -1', 'men', '102 healthy men, 21-50 years (mean age 38', 'Men']","['controlled diets with 0.8 g *  kg -1   *  day -1  protein or 1.3 g *  kg -1   *  day -1  protein plus placebo or TE', 'testosterone', 'Testosterone', 'enanthate (TE) plus placebo', '5α-Reductase (5aR']","['total and differential leukocyte count, and platelet count', 'monocyte', 'total leukocyte', 'total leukocyte count', 'Peripheral Neutrophils, Monocytes and Platelets', 'platelet', 'neutrophil and monocyte counts', 'absolute lymphocyte count', 'neutrophil', 'erythrocyte counts']","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0019226', 'cui_str': 'Enanthates'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162401', 'cui_str': 'Differential white blood cell count procedure'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",102.0,0.505029,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Gagliano-Jucá', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Andrology,['10.1111/andr.12834']
1291,32485112,"Effect of Platelet-Rich Plasma on Nonsurgically Treated Acute Achilles Tendon Ruptures: A Randomized, Double-Blinded Prospective Study.","BACKGROUND


An acute Achilles tendon rupture (ATR) is a long-lasting and devastating injury. Possible biological augmentation to promote and strengthen tendon healing after an ATR would be desirable.
PURPOSE


To determine whether the application of a platelet-rich plasma (PRP) injection in nonsurgically treated ATRs may promote healing and thereby improve functional outcomes.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months. All patients were treated with an orthosis with 3 wedges for 8 weeks; full weightbearing from day 1 was allowed, combined with either 4 PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin) 14 days apart. All patients received the same instructions on an exercise program starting from week 9. Outcomes included the self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion.
RESULTS


The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group). No differences in all functional outcomes at any time points were seen between the groups. At 12 months, the injured leg did not reach normal functional values compared with the uninjured leg.
CONCLUSION


The application of PRP in nonsurgically treated ATRs did not appear to show any superior clinical and functional improvement.
REGISTRATION


NCT02417922 (ClinicalTrials.gov identifier).",2020,"The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","['40 men (aged 18-60 years) with an ATR incurred within 72 hours were included, and 38 were followed for 12 months', 'Nonsurgically Treated Acute Achilles Tendon Ruptures']","['PRP or 4 placebo injections (a few drops of saline, <0.5 mL, under the skin', 'Platelet-Rich Plasma', 'platelet-rich plasma (PRP) injection']","['self-reported Achilles tendon Total Rupture Score (ATRS) as well as heel-rise work, heel-rise height, tendon elongation, calf circumference, and ankle dorsiflexion range of motion', 'mean ATRS score']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0856439', 'cui_str': 'Tendon elongation'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",72.0,0.431477,"The mean ATRS score improved in both groups at all time points ( P  < .001), but there was no difference between the groups at any time points (12 months: 90.1 points in PRP group and 88.8 points in placebo group).","[{'ForeName': 'Anders Ploug', 'Initials': 'AP', 'LastName': 'Boesen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Ilum', 'Initials': 'MI', 'LastName': 'Boesen', 'Affiliation': 'Department Of Orthopaedics, Køge Sygehus, Køge, Denmark.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Hansen', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristoffer Weisskirchner', 'Initials': 'KW', 'LastName': 'Barfod', 'Affiliation': 'Department of Orthopaedic Surgery, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lenskjold', 'Affiliation': 'Institute of Sports Medicine, Department of Orthopaedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Malliaras', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'CopenRehab, Section of Social Medicine, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of sports medicine,['10.1177/0363546520922541']
1292,32589670,"Does the type of foam roller influence the recovery rate, thermal response and DOMS prevention?","PURPOSE


Supporting post-exercise recovery requires choosing not only the right treatment but also the equipment, in which the impact is not always clear. The study aimed to determine the effect of foam rolling on the rate of lactate removal and DOMS prevention and whether the type of foam roller is effective in the context of post-exercise recovery.
METHODS


This randomized trial enrolled 33 active healthy males divided into three groups of eleven individuals: foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS). All the participants performed full squat jumps for one minute. Examination took place at rest (thermal imaging of skin temperature-[Tsk] and blood lactate-[LA]), immediately following exercise (Tsk & LA), immediately after recovery treatment (Tsk) and after 30 minutes of rest (Tsk & LA). Their pain levels were assessed using the Visual Analog Scale (VAS) 24, 48, 72, and 96 hours after exercise.
RESULTS


The magnitude of lactate decrease depended on the type of recovery used. In the PAS group, the decrease in lactate concentration by 2.65 mmol/L following a half-hour rest was significantly lower than that in the other groups (STH vs. PAS p = 0.042 / GRID vs. PAS p = 0.025). For thermal responses, significant differences between both experimental groups were noted only 30 minutes after exercise. A significant decrease in pain in the STH group occurred between 48 and 96 hours, while the GRID group showed a systematic significant decrease in VAS values in subsequent measurements. Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05).
CONCLUSIONS


Foam rolling seems to be effective for enhancing lactate clearance and counteracting DOMS, but the type of foam roller does not seem to influence the recovery rate.",2020,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05).
",['33 active healthy males divided into three groups of eleven individuals'],['foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS'],"['VAS values', 'lactate concentration', 'pain levels', 'recovery rate, thermal response and DOMS prevention', 'pain']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",33.0,0.0430707,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05).
","[{'ForeName': 'Jakub Grzegorz', 'Initials': 'JG', 'LastName': 'Adamczyk', 'Affiliation': 'Theory of Sport Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Gryko', 'Affiliation': 'Athletics and Team Sport Games Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Boguszewski', 'Affiliation': 'Rehabilitation Department, Physiotherapy Division, Medical University of Warsaw, Warsaw, Poland.'}]",PloS one,['10.1371/journal.pone.0235195']
1293,32591421,"A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study.","OBJECTIVE


While the adjustment of insulin is an established strategy to reduce the risk of exercise-associated hypoglycemia for individuals with type 1 diabetes, it is not easily feasible for those treated with ultra-long-acting basal insulin. The current study determined whether pre-exercise intake of fructose attenuates the risk of exercise-induced hypoglycemia in individuals with type 1 diabetes using insulin degludec.
RESEARCH DESIGN AND METHODS


Fourteen male adults with type 1 diabetes completed two 60-min aerobic cycling sessions with or without prior intake (30 min) of 20 g of fructose, in a randomized two-period crossover design. Exercise was performed in the morning in a fasted state without prior insulin reduction and after 48 h of standardized diet. The primary outcome was time to hypoglycemia (plasma glucose ≤3.9 mmol/L) during exercise.
RESULTS


Intake of fructose resulted in one hypoglycemic event at 60 min compared with six hypoglycemic events at 27.5 ± 9.4 min of exercise in the control condition, translating into a risk reduction of 87.8% (hazard ratio 0.12 [95% CI 0.02, 0.66];  P  = 0.015). Mean plasma glucose during exercise was 7.3 ± 1.4 mmol/L with fructose and 5.5 ± 1.1 mmol/L in the control group ( P  < 0.001). Lactate levels were higher at rest in the 30 min following fructose intake ( P  < 0.001) but were not significantly different from the control group during exercise ( P  = 0.32). Substrate oxidation during exercise did not significantly differ between the conditions ( P  = 0.73 for carbohydrate and  P  = 0.48 for fat oxidation). Fructose was well tolerated.
CONCLUSIONS


Pre-exercise intake of fructose is an easily feasible, effective, and well-tolerated strategy to alleviate the risk of exercise-induced hypoglycemia while avoiding hyperglycemia in individuals with type 1 diabetes on ultra-long-acting insulin.",2020,Substrate oxidation during exercise did not significantly differ between the conditions ( P  = 0.73 for carbohydrate and  P  = 0.48 for fat oxidation).,"['Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin', 'individuals with type 1 diabetes using insulin degludec', 'Fourteen male adults with type 1 diabetes', 'individuals with type 1 diabetes']","['Fructose', '60-min aerobic cycling sessions with or without prior intake (30 min) of 20 g of fructose']","['Lactate levels', 'Mean plasma glucose', 'tolerated', 'hypoglycemic event', 'time to hypoglycemia (plasma glucose ≤3.9 mmol/L) during exercise', 'Substrate oxidation during exercise']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0450403', 'cui_str': '20G'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",14.0,0.0650296,Substrate oxidation during exercise did not significantly differ between the conditions ( P  = 0.73 for carbohydrate and  P  = 0.48 for fat oxidation).,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Kosinski', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Céline Isabelle', 'Initials': 'CI', 'LastName': 'Laesser', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christos T', 'Initials': 'CT', 'LastName': 'Nakas', 'Affiliation': 'Laboratory of Biometry, School of Agriculture, University of Thessaly, Nea Ionia Magnesia, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Melmer', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Laimer', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland christoph.stettler@insel.ch.'}]",Diabetes care,['10.2337/dc19-2250']
1294,32594522,"Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial.","BACKGROUND


Patients with plaque psoriasis treated with biologic therapies need more efficacious, safe and convenient treatments to improve quality of life. Risankizumab and secukinumab inhibit interleukin-23 and interleukin-17A, respectively, and are effective in adult patients with moderate-to-severe plaque psoriasis but have different dosing regimens.
OBJECTIVES


To compare directly the efficacy and safety of risankizumab vs. secukinumab over 52 weeks.
METHODS


IMMerge was an international, phase III, multicentre, open-label, efficacy-assessor-blinded, active-comparator study, in which adult patients with chronic, moderate-to-severe plaque psoriasis were randomized in a 1 : 1 ratio to treatment with risankizumab 150 mg or secukinumab 300 mg. Primary efficacy endpoints were the proportions of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison).
RESULTS


In total 327 patients from nine countries were treated with risankizumab (n = 164) or secukinumab (n = 163). Risankizumab was noninferior to secukinumab in the proportion of patients achieving PASI 90 at week 16 [73·8% vs. 65·6%; difference of 8·2%, 96·25% confidence interval (CI)-2·2 to 18·6; within the 12% noninferiority margin] and superior to secukinumab at week 52 (86·6% vs. 57·1%; difference of 29·8%, 95% CI 20·8-38·8; P < 0·001), thus meeting both primary endpoints. All secondary endpoints (PASI 100, static Physician's Global Assessment 0 or 1, and PASI 75) at week 52 demonstrated superiority for risankizumab vs. secukinumab (P < 0·001). No new safety concerns were identified.
CONCLUSIONS


At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.",2020,"Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points.","['adult patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis (IMMerge', '327 patients from nine countries', 'adult patients with chronic, moderate-to-severe plaque psoriasis', 'Patients with plaque psoriasis treated with']","['Risankizumab and secukinumab inhibit interleukin (IL)-23 and IL-17A', 'biologic therapies', 'risankizumab vs. secukinumab', 'risankizumab', 'risankizumab 150mg or secukinumab 300mg', 'secukinumab', 'Risankizumab']","['quality of life', 'points (PASI 100, static Physician Global Assessment 0 or 1, and PASI 75', 'Efficacy and safety', 'Psoriasis Area Severity Index (PASI 90']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}]",327.0,0.270528,"Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points.","[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Centre, Portland, OR, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Laval University and Centre de Recherche Dermatologique du Québec Métropolitain, Québec City, QC, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beeck', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Paul Sabatier University and Larrey Hospital, Toulouse, France.'}]",The British journal of dermatology,['10.1111/bjd.19341']
1295,32595083,Family Mealtime Communication in Single- and Dual-Headed Households Among Hispanic Adolescents With Overweight and Obesity.,"OBJECTIVE


To investigate the association of adolescent self-report of family mealtime communication on obesity-related behaviors in single- and dual-parent households and by sex in a sample of overweight and obese Hispanic adolescents.
DESIGN


Cross-sectional analysis of a randomized control trial SETTING: Eighteen middle schools in Miami-Dade County, Florida.
PARTICIPANTS


Two-hundred and eighty Hispanic seventh- and eighth-grade students MAIN OUTCOME MEASURES: Physical activity, fruit and vegetable intake, and added sugar intake.
ANALYSIS


Structural equation modeling.
RESULTS


The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30). Moreover, a single-parent household was associated with dietary consumption in boys (fruit and vegetable intake [β= .18; P = .039; 95% CI, 0.02-2.60] but had a moderating effect on fruit and vegetable consumption in girls (β = .21; P = .015; 95% CI, 0.14-2.19).
CONCLUSIONS AND IMPLICATIONS


Family mealtime communication may impact dietary and physical activity outcomes in Hispanic adolescents with overweight and obesity, but differentially across gender and household parent makeup. These findings, together with the prevalence of single parents, point to the importance of targeting Hispanic single parents as agents of change to promote healthy lifestyle behaviors in their children via positive mealtime interactions.",2020,"The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30).","['single- and dual-parent households and by sex in a sample of overweight and obese Hispanic adolescents', 'Hispanic Adolescents With Overweight and Obesity', 'Two-hundred and eighty Hispanic seventh- and eighth-grade students', 'Eighteen middle schools in Miami-Dade County, Florida', 'Hispanic adolescents with overweight and obesity']",['family mealtime communication'],"['fruit and vegetable consumption', 'physical activity', 'Physical activity, fruit and vegetable intake, and added sugar intake', 'healthy lifestyle behaviors']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0046889', 'cui_str': ""3,3'-diallyldiethylstilbestrol""}, {'cui': 'C0016253', 'cui_str': 'Florida'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",280.0,0.0816013,"The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30).","[{'ForeName': 'Cynthia N', 'Initials': 'CN', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL. Electronic address: Clebron@med.miami.edu.'}, {'ForeName': 'Yaray', 'Initials': 'Y', 'LastName': 'Agosto', 'Affiliation': 'Department of Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Sara M St', 'Initials': 'SMS', 'LastName': 'George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Pantin', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': ""University of Texas Health Science Center, School of Public Health, Dallas, TX; Center for Pediatric Population Health, Children's Health System of Texas and UTHealth School of Public Health, Dallas, TX.""}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.03.003']
1296,32611643,Suitability of external controls for drug evaluation in Duchenne muscular dystrophy.,"OBJECTIVE


To evaluate the suitability of real-world data (RWD) and natural history data (NHD) for use as external controls in drug evaluations for ambulatory Duchenne muscular dystrophy (DMD).
METHODS


The consistency of changes in the 6-minute walk distance (Δ6MWD) was assessed across multiple clinical trial placebo arms and sources of NHD/RWD. Six placebo arms reporting 48-week Δ6MWD were identified via literature review and represented 4 sets of inclusion/exclusion criteria (n = 383 patients in total). Five sources of RWD/NHD were contributed by Universitaire Ziekenhuizen Leuven, DMD Italian Group, The Cooperative International Neuromuscular Research Group, ImagingDMD, and the PRO-DMD-01 study (n = 430 patients, in total). Mean Δ6MWD was compared between each placebo arm and RWD/NHD source after subjecting the latter to the inclusion/exclusion criteria of the trial for baseline age, ambulatory function, and steroid use. Baseline covariate adjustment was investigated in a subset of patients with available data.
RESULTS


Analyses included ∼1,200 patient-years of follow-up. Differences in mean Δ6MWD between trial placebo arms and RWD/NHD cohorts ranged from -19.4 m (i.e., better outcomes in RWD/NHD) to 19.5 m (i.e., worse outcomes in RWD/NHD) and were not statistically significant before or after covariate adjustment.
CONCLUSIONS


We found that Δ6MWD was consistent between placebo arms and RWD/NHD subjected to equivalent inclusion/exclusion criteria. No evidence for systematic bias was detected. These findings are encouraging for the use of RWD/NHD to augment, or possibly replace, placebo controls in DMD trials. Multi-institution collaboration through the Collaborative Trajectory Analysis Project rendered this study feasible.",2020,The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD.,"['ambulatory Duchenne muscular dystrophy (DMD', 'Duchenne muscular dystrophy']","['real-world data (RWD) and natural history data (NHD', 'Six placebo', 'placebo']","['Mean Δ6MWD', 'mean Δ6MWD']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",430.0,0.447587,The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gordish-Dressman', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Vandenborne', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': ""From the University Hospitals Leuven (N.G.), Child Neurology, Belgium; Analysis Group, Inc (J.S., G.S., Z.Y.), Boston; Collaborative Trajectory Analysis Project (J.S., S.J.W.), Cambridge, MA; Children's National Medical Center (H.G.-D.), Research Center for Genetic Medicine, Washington, DC; Department of Physical Medicine and Rehabilitation and Pediatrics (C.M.M.), University of California, Davis, Sacramento; Department of Physical Therapy (K.V.), University of Florida, Gainesville; CureDuchenne (D.M.), Newport Beach, CA; and Department of Pediatric Neurology (E.M.), Fondazione Policlinico Gemelli IRCCS, Catholic University, Rome, Italy. eugeniomaria.mercuri@unicatt.it.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010170']
1297,32613332,Matching Psychosocial Support Needs of Parents of a Child with a Chronic Illness to a Feasible Intervention.,"OBJECTIVES


Parents of children with a chronic illness (CI) are at risk for psychosocial problems. The aim of this study was to refine an existing face-to-face intervention into an online psychosocial group intervention for parents by (1) exploring which themes are important, (2) determine what type of intervention parents would like and (3) assess parents' practical preferences.
METHODS


Parents of children with a CI (0-18 years) were invited to complete an online questionnaire. To acquire more in-depth information, focus groups and telephone interviews were conducted. Descriptive statistics were used.
RESULTS


272 parents (mean age = 43.1 years, 85% female) participated. Three focus groups (15 parents) and seven telephone interviews were conducted. Most important themes were: the CI of the child, family functioning, taking care of yourself, relationships with others and practical support. Parents preferred a group with parents of children in the same age category. At first, parents preferred face-to-face contact. After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home.
CONCLUSIONS FOR PRACTICE


Parents have a need for psychosocial support focusing on different themes. Professionals should explain and demonstrate an online intervention to parents. Based on these results, Op Koers Online for parents was developed. An RCT to assess feasibility and effectiveness of the intervention is currently running.",2020,"After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home.
","['Parents of children with a chronic illness (CI', 'Parents of children with a CI (0-18\xa0years', '272 parents (mean age\u2009=\u200943.1\xa0years, 85% female) participated']",[],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],272.0,0.0280083,"After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home.
","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Douma', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.douma@amsterdamumc.nl.""}, {'ForeName': 'Charlotte P', 'Initials': 'CP', 'LastName': 'Bouman', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Hedy A', 'Initials': 'HA', 'LastName': 'van Oers', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Maurice-Stam', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Haverman', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Grootenhuis', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Linde', 'Initials': 'L', 'LastName': 'Scholten', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}]",Maternal and child health journal,['10.1007/s10995-020-02925-3']
1298,32614699,"Teriparatide Promotes Bone Healing in Medication-Related Osteonecrosis of the Jaw: A Placebo-Controlled, Randomized Trial.","PURPOSE


Medication-related osteonecrosis of the jaw (MRONJ) is an infrequent but morbid and potentially serious condition associated with antiresorptive and antiangiogenic therapies. Although MRONJ can be prevented by optimizing oral health, management of established cases is supportive and remains challenging. Teriparatide, an osteoanabolic agent that improves bone healing in preclinical studies and in chronic periodontitis, represents a potential treatment option.
PATIENTS AND METHODS


In a double-blind, randomized, controlled trial, 34 participants with established MRONJ, with a total of 47 distinct MRONJ lesions, were allocated to either 8 weeks of subcutaneous teriparatide (20 µg/day) or placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care. Participants were observed for 12 months, with primary outcomes that included the clinical and radiologic resolution of MRONJ lesions. Secondary outcomes included osteoblastic responses as measured biochemically and radiologically and changes in quality of life.
RESULTS


Teriparatide was associated with a greater rate of resolution of MRONJ lesions (odds ratio [OR], 0.15  v  0.40;  P  = .013), and 45.4% of lesions resolved by 52 weeks compared with 33.3% in the placebo group. Teriparatide was also associated with reduced bony defects at week 52 (OR, 8.1;  P  = .017). The incidence of adverse events was balanced between groups, including nausea, anorexia, and musculoskeletal pain, most of mild severity.
CONCLUSION


Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.",2020,Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.,"['Medication-Related Osteonecrosis of the Jaw', '34 participants with established MRONJ, with a total of 47 distinct MRONJ lesions']","['Placebo', 'subcutaneous teriparatide', 'Teriparatide', 'placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care', 'placebo']","['nausea, anorexia, and musculoskeletal pain, most of mild severity', 'rate of resolution of MRONJ lesions', 'reduced bony defects', 'clinical and radiologic resolution of MRONJ lesions', 'bone healing', 'osteoblastic responses as measured biochemically and radiologically and changes in quality of life', 'adverse events']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",34.0,0.409353,Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.,"[{'ForeName': 'Ie-Wen', 'Initials': 'IW', 'LastName': 'Sim', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gelsomina L', 'Initials': 'GL', 'LastName': 'Borromeo', 'Affiliation': 'Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Tsao', 'Affiliation': 'Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Hardiman', 'Affiliation': 'Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Papatziamos Hjelle', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Musib', 'Initials': 'M', 'LastName': 'Siddique', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Gary J R', 'Initials': 'GJR', 'LastName': 'Cook', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02192']
1299,32615994,Inhaled granulocyte-macrophage colony stimulating factor for mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24 months of follow-up.,"BACKGROUND


Treatment of autoimmune pulmonary alveolar proteinosis (aPAP) by inhaled granulocyte-macrophage colony stimulating factor (GM-CSF) is considered safe and effective. Evidence of benefit from GM-CSG inhalation for mild to moderate aPAP patients is limited.
METHODS


In this multicenter, randomized, open-labeled clinical trial, 36 aPAP patients with mild to moderate disease severity were randomized into either the GM-CSF treatment group or control group. Inhaled GM-CSF was prescribed for 6 months, and patients received follow-up for another 18 months without treatment. Physiological features of the patients were analyzed.
RESULTS


There were 36 patients (19 in the treatment group, 17 in the control group) included. There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]). Percentage of diffusion capacity predicted (DLCO%) and percentage of total lung capacity predicted (TLC%), however, were significantly improved in the treatment group by the end of the study (P = 0.010 and 0.027). St. George Respiratory questionnaire (SGRQ) scores were better after 6 months treatment with GM-CSF compared to the control group, and the benefits of treatment were maintained throughout the observation period. No severe side effects were observed during the study.
CONCLUSION


Six months of inhaled GM-CSF treatment had no effect on the alveolar-arterial oxygen gradient in patients with mild to moderate pulmonary alveolar proteinosis. There were changes in some clinical or laboratory measures, but no clinically important changes were noted at the end of study. (Clinical Trial Registry: NCT02243228, Registered on September 17, 2014, https://www.clinicaltrials.gov/ct2/show/NCT02243228?term=NCT02243228&draw=2&rank=1 ).",2020,"There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]).","['36 patients (19 in the treatment group, 17 in the control group) included', 'patients with mild to moderate pulmonary alveolar proteinosis', '36 aPAP patients with mild to moderate disease severity', 'mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24\u2009months of follow-up', 'mild to moderate aPAP patients']","['inhaled GM-CSF', 'Inhaled granulocyte-macrophage colony stimulating factor', 'GM-CSG inhalation', 'inhaled granulocyte-macrophage colony stimulating factor (GM-CSF', 'GM-CSF treatment group or control group', 'Inhaled GM-CSF']","['alveolar-arterial oxygen gradient', 'Percentage of diffusion capacity predicted (DLCO%) and percentage of total lung capacity predicted (TLC', 'change of alveolar arterial oxygen gradient', 'St. George Respiratory questionnaire (SGRQ) scores', 'severe side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0034050', 'cui_str': 'Pulmonary alveolar proteinosis'}, {'cui': 'C1970472', 'cui_str': 'Autoimmune pulmonary alveolar proteinosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3203470', 'cui_str': 'Alveolar-arterial oxygen gradient'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0040509', 'cui_str': 'Total lung capacity'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",36.0,0.0306328,"There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]).","[{'ForeName': 'Xinlun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Jiangsu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenshuai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaobei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingshan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yusen', 'Initials': 'Y', 'LastName': 'Situ', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Meng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yonglong', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Jiangsu, China. yonglongxiao@sina.cn.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. xukf@pumch.cn.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01450-4']
1300,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND


The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.
METHODS


We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233.
FINDINGS


Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
INTERPRETATION


ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing.
FUNDING


The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2']
1301,32620131,Gait improvements by assisting hip movements with the robot in children with cerebral palsy: a pilot randomized controlled trial.,"BACKGROUND


Recently, rehabilitation robots are expected to improve the gait of cerebral palsy (CP) children. However, only few previous studies have reported the kinematic and kinetic changes by using wearable exoskeleton robots. The aim of this study was to investigate the change in gait parameters in CP children by training with the wearable robot-assisted gait training.
METHODS


10 spastic CP children with Gross Motor Function Classification Scale levels I-III completed a sham-controlled crossover randomized trial. Robot-assisted gait training (RAGT) and non-assisted gait training (NAGT) were performed on the treadmill with the Honda Walking Assist (HWA) in two different days. To examine the carry-over effect from treadmill walking to overground walking, participants also performed 5.5 m overground-walks without the HWA before and after treadmill training (pre- and post-trial). During treadmill walking, peak of both hip and knee angles were measured. Also, we calculated the limb symmetry of hip range of motion. In addition, gait speed and ground reaction force were measured in overground trials.
RESULTS


The maximum hip angle on the limb with fewer hip movements, which was defined as the affected limb, showed a significant interaction between ASSIST (RAGT and NAGT) and TIME (pre- and post-trial) (p < 0.05). Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT. Furthermore, the affected limb showed a significant increase in the positive peak of the anterior-posterior ground reaction force during 70-100% of the gait cycle (p < 0.05). However, there was no change in gait speed.
CONCLUSION


By assisting the both hip movements with the HWA, maximum hip flexion and extension angle of the affected limb improved. Also, limb symmetry and propulsion force of the affected limb improved. Our results suggest that assisting both hip movements with the HWA might be an effective method for improving gait in CP children.
TRIAL REGISTRATION


UMIN-CTR, UMIN000030667. Registered 3 January 2018, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033737.",2020,"Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT.","['10 spastic CP children with Gross Motor Function Classification Scale levels I-III completed a sham-controlled crossover randomized trial', 'CP children by training with the wearable robot-assisted gait training', 'children with cerebral palsy', 'cerebral palsy (CP) children']","['Robot-assisted gait training (RAGT) and non-assisted gait training (NAGT', 'treadmill walking to overground walking, participants also performed 5.5\u2009m overground-walks without the HWA before and after treadmill training']","['Gait improvements', 'positive peak of the anterior-posterior ground reaction force', 'maximum hip angle on the limb with fewer hip movements', 'gait speed', 'limb symmetry of hip range of motion', 'gait speed and ground reaction force', 'Limb symmetry', 'gait parameters', 'limb symmetry and propulsion force']","[{'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0698618,"Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT.","[{'ForeName': 'Shihomi', 'Initials': 'S', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan. kawasaki.shihomi.55n@kyoto-u.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Shigehito', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00712-3']
1302,32647911,Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study.,"INTRODUCTION


The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.
METHODS


Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.
RESULTS


The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.
CONCLUSIONS


This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.
TRIAL REGISTRATION NUMBER


NCT02164513.",2020,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"['10,355 patients (TDI population: 5058 patients', 'COPD', 'patients enrolled at study sites in North America and Europe', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate (FF) 100\xa0μg, umeclidinium (UMEC) 62.5\xa0μg, and vilanterol (VI']","[""St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI"", 'SGRQ total score', 'rate of moderate or severe exacerbations', 'CAT and TDI focal score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",10355.0,0.664861,Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI,"[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK. margaret.x.tabberer@gsk.com.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline plc, Research Triangle Park, NC, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline plc, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'The Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'The Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Morrys C', 'Initials': 'MC', 'LastName': 'Kaisermann', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline plc, Collegeville, PA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01409-8']
1303,32645169,"Garzon R, Savona M, Baz R, et al. A phase 1 clinical trial of single-agent selinexor in acute myeloid leukemia. Blood. 2017;129(24):3165-3174.",,2020,,['acute myeloid leukemia'],['single-agent selinexor'],[],"[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3852671', 'cui_str': 'Selinexor'}]",[],,0.0224881,,[],Blood,['10.1182/blood.2020007231']
1304,32645640,The ocrelizumab phase II extension trial suggests the potential to improve the risk: Benefit balance in multiple sclerosis.,"OBJECTIVE


Ocrelizumab inhibits relapsing multiple sclerosis when administered every six months. Based on potential similar memory B cell depletion mechanisms with cladribine and alemtuzumab, we hypothesised that CD20-depletion of B cells by ocrelizumab may exhibit a duration of response exceeding the current licenced treatment interval.
METHODS


Internet-located information from regulatory submissions and meeting reports relating to the unpublished open-label, phase II ocrelizumab extension trial (NCT00676715) were reviewed. This followed people (54-55/arm) with MS, who switched from placebo or interferon-beta to ocrelizumab for three 600 mg treatment cycles (week 24, 48, 72) or people treated with ocrelizumab for four 600 mg treatment cycles (week 0-72), followed by an 18 month treatment-free period.
RESULTS


CD19+ B cells were rapidly depleted within 2 weeks and slow CD19+ B cell repopulation began about 6 months after the last infusion with median-repletion of over 15 months. The reduced annualized relapse rate during the published efficacy study appeared to be maintained in the extension study and there were no new T1 gadolinium-enhancing or T2 lesions detected in the treatment-free period. Importantly, within these extension cohorts, there appeared to be fewer adverse events and infections events.
CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles Therefore, it may be possible to reduce the frequency of dosing to maintain efficacy, whilst limiting infection and other risks associated with continuous immunosuppression and could allow more effective vaccination against new pathogens. Further studies are now clearly required to determine whether this data is robust.",2020,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles",[],"['placebo or interferon-beta to ocrelizumab', 'cladribine and alemtuzumab', 'Ocrelizumab', 'ocrelizumab']","['annualized relapse rate', 'new T1 gadolinium-enhancing or T2 lesions']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.0255681,"CONCLUSIONS


Ocrelizumab appears to induce durable relapsing disease inhibition, within 3 treatment cycles","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom. Electronic address: david.baker@qmul.ac.uk.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Pryce', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Louisa K', 'Initials': 'LK', 'LastName': 'James', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Marta', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmierer', 'Affiliation': 'Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 2AT, United Kingdom; Clinical Board:Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London E1 1BB, United Kingdom.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102279']
1305,32591219,Cognitive Behavioral Sex Therapy: An Emerging Treatment Option for Nonorganic Erectile Dysfunction in Young Men: A Feasibility Pilot Study.,"INTRODUCTION


An increasing number of young men have been found to develop nonorganic erectile dysfunction (NOED) in recent years. The NOED has been shown to respond better to cognitive behavior sex therapy (CBST) in a few past studies.
AIM


The present research aims to establish the efficacy of CBST as a promising treatment option in young men suffering from NOED by administering a feasibility pilot trial.
METHODS


28 young men (M = 31 years) out of a total of 39 men (7 excluded, 4 quit treatment) diagnosed with NOED from sexual health clinics in Pakistan were recruited to receive CBST treatment (n = 13) on average twice a week for a period of 50 minutes per session for a period of 4, 6, 8, and 12 weeks for the mild, mild to moderate, moderate, and severe forms of NOED, respectively, and sildenafil citrate group (n = 15) receiving sildenafil citrate 50 mg on demand. The trial design was sequential random assignment clinical trial.
MAIN OUTCOME MEASURES


International Index of Erectile Functoning-5 and Depression Anxiety Stress Scale-21 were used before treatment, after treatment, and in follow-up as the main outcome measures.
RESULTS


The repeated measures analysis of covariance established a nonsignificant difference between CBST and sildenafil citrate 50 mg in NOED scores improvement, NOED severity reduction, and reduction in depression scores at posttreatment assessment. There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores. There was significant difference in CBST and sildenafil citrate 50 mg in anxiety reduction at posttreatment assessment. The covariates age, age groups, and NOED duration did not significantly impact the treatment outcome for both treatment groups except age which impacted the interaction of treatment and anxiety scores.
CONCLUSION


The CBST is an emerging and promising treatment choice in younger men suffering from NOED. Bilal A, Abbasi NuH. Cognitive Behavioral Sex Therapy: An Emerging Treatment Option for Nonorganic Erectile Dysfunction in Young Men: A Feasibility Pilot Study. J Sex Med 2020;8:396-407.",2020,"There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores.","['28 young men (M\xa0', 'Young Men', 'young men suffering from NOED', '31\xa0years) out of a total of 39 men (7 excluded, 4 quit treatment) diagnosed with NOED from sexual health clinics in Pakistan', 'younger men suffering from NOED']","['Cognitive Behavioral Sex Therapy', 'Abbasi NuH. Cognitive Behavioral Sex Therapy', 'CBST and sildenafil citrate', 'CBST', 'CBST treatment', 'sildenafil citrate 50\xa0mg on demand', 'sildenafil citrate']","['NOED scores improvement, NOED severity reduction, and reduction in depression scores', 'CBST and sildenafil citrate 50', 'International Index of Erectile Functoning-5 and Depression Anxiety Stress Scale-21', 'anxiety reduction', 'anxiety scores', 'NOED scores, reduction in NOED severity, and depression scores']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3839552', 'cui_str': 'Sexual health clinic'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",28.0,0.0202324,"There were significant differences among different CBST modalities in improving NOED scores, reduction in NOED severity, and depression scores.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Bilal', 'Affiliation': 'PhD Research Scholar, Department of Psychology, International Islamic University, Islamabad, Pakistan. Electronic address: ahmadbilal4@gmail.com.'}, {'ForeName': 'Najam Ul Hasan', 'Initials': 'NUH', 'LastName': 'Abbasi', 'Affiliation': 'Assistant Professor, Department of Psychology, International Islamic University, Islamabad, Pakistan.'}]",Sexual medicine,['10.1016/j.esxm.2020.05.005']
1306,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE


To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM).
METHODS


A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated.
RESULTS


Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
CONCLUSIONS


The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively.
","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024']
1307,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE


To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK).
METHOD


The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting.
RESULTS


The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed.
CONCLUSION


Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005']
1308,32594451,Efficacy and safety of hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs.,"OBJECTIVE


To evaluate the Safety and Efficacy of Hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs.
MATERIALS AND METHODS


This was a double blind, placebo controlled, parallel group study in 304 inadequately controlled type 2 diabetes (T2DM) subjects with two oral antidiabetic drugs (glimepiride 4 mg and metformin 500 mg) were randomised to hydroxychloroquine (HCQ) 200 mg, 300 mg, 400 mg once daily (OD) or placebo. Dose of hydroxychloroquine was selected as per body weight of the subject. Primary end point was glycated haemoglobin (HbA1c) change at week 12 from baseline. Secondary endpoint was change in fasting plasma glucose (FPG), post prandial plasma glucose (PPG), body weight and any adverse reaction including no of hypoglycemic events, as well as a change in the percentage of subjects with A1C < 7.0% and > 6.5% after 12 weeks of treatment.. In follow-up of 400 mg once daily was once again divided to 200 mg twice daily (BD) to study the effect on tolerability profile for further 12 weeks.
RESULTS


Hydroxychloroquine was associated with significant reduction in HbA1c from baseline (7-8.5%) in 12 weeks -0.78%, -0.91% and 1.2% for hydroxychloroquine 200 mg, 300 mg and 400 mg OD, respectively, versus 0.13% with placebo (P < 0.005). FPG and PPG were reduced by -25 to -38 mg/dl and 34-53 mg/dl, respectively. Body weight also reduced in each group of HCQ. Hypoglycemia was reported only with 300 mg (1.2%) and 400 mg (2.1%) group of HCQ. It was observed that patients who complains with mild GI disturbance with HCQ 400 mg glycemic efficacy was maintained with 200 mg BD with significant relief of the symptoms.
CONCLUSION


Hydroxychloroquine added to sulphonylurea and metformin, improves glycemic control significantly in T2DM patients. Glycemic effect of different dose of hydroxychloroquine is dose dependent. The safety/tolerability profile of hydroxychloroquine was favourable except GI disturbance which is more frequent with 400 mg. This can be avoided with 200 mg BD without compromise on efficacy.",2020,"FPG and PPG were reduced by -25 to -38 mg/dl and 34-53 mg/dl, respectively.","['500\xa0mg', '304 inadequately controlled type 2 diabetes (T2DM) subjects with two', 'T2DM patients', 'uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs']","['hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'sulphonylurea and metformin', 'oral antidiabetic drugs (glimepiride 4\xa0mg and metformin', 'placebo']","['Hypoglycemia', 'Safety and Efficacy', 'FPG and PPG', 'safety/tolerability profile', 'glycated haemoglobin (HbA1c) change', 'Efficacy and safety', 'Body weight', 'glycemic control', 'tolerability profile', 'glycemic efficacy', 'Glycemic effect', 'fasting plasma glucose (FPG), post prandial plasma glucose (PPG), body weight and any adverse reaction including no of hypoglycemic events, as well as a change in the percentage of subjects with A1C']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0986240', 'cui_str': 'glimepiride 4 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",,0.111767,"FPG and PPG were reduced by -25 to -38 mg/dl and 34-53 mg/dl, respectively.","[{'ForeName': 'H N', 'Initials': 'HN', 'LastName': 'Chakravarti', 'Affiliation': 'Department of Medicine, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nag', 'Affiliation': 'Department of Medicine, Medical College and Hospital, Kolkata, West Bengal, India. dravicknag@rediffmail.com.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01330-5']
1309,32602592,Cognitive evolutionary therapy versus standard cognitive therapy for depression: A single-blinded randomized clinical trial.,"OBJECTIVE


To compare the efficacy of cognitive evolutionary therapy (CET) with cognitive therapy (CT) for depression.
METHODS


Ninety-seven participants (78 females/19 males) were randomized to a single-blinded controlled trial (CET: n = 51 vs. CT: n = 46). Assessments were conducted at baseline, Sessions 4 and 8, posttreatment, and 3-month follow-up. Clinical diagnoses were made with Structured Clinical Interview for DSM-IV (SCID) and self-reports for depression and secondary outcomes.
RESULTS


Although both groups showed significant reductions in depressive symptomatology, the overall Time × Treatment group interaction in the intent to treat analysis was not significant (p = .770, posttreatment: d = 0.39). However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62). The between-group differences generally diminished at the 3-month follow-up.
CONCLUSIONS


CET is a novel therapy for depression that may add therapeutic benefits beyond those of CT.",2020,"However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62).","['Ninety-seven participants (78\xa0females/19\xa0males', 'depression']","['CT', 'cognitive evolutionary therapy (CET) with cognitive therapy (CT', 'Cognitive evolutionary therapy versus standard cognitive therapy', 'CET']","['depressive symptomatology', 'behavioral inhibition/avoidance', 'social and enjoyable activities']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",97.0,0.0923318,"However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62).","[{'ForeName': 'Cezar', 'Initials': 'C', 'LastName': 'Giosan', 'Affiliation': 'Department of Psychology, University of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Cobeanu', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Epidemiology and Biostatistics, Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Muresan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mogoase', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Szentagotai', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Malta', 'Affiliation': 'Capital Psychological Associates, Albany, New York, USA.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Moldovan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}]",Journal of clinical psychology,['10.1002/jclp.22991']
1310,32603380,Treatment outcomes of Pumani bubble-CPAP versus oxygen therapy among preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial.,"BACKGROUND


Respiratory distress syndrome (RDS) is the most common respiratory disease in premature babies and the major cause of morbidity and mortality among preterm babies. Effective treatment of these babies requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in low and middle income countries. A cheaper, simpler and more accessible treatment for preterms with RDS called bubble-continuous positive airway pressure (bCPAP) has been reported to be effective in treating RDS in preterm babies with varying levels of effectiveness ranging from 42% to 85%. We aimed to implement and determine the efficacy of bCPAP and its immediate outcomes as compared to oxygen therapy in preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania.
METHOD


A randomized control trial, conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria. The primary outcome was survival while the secondary outcomes were treatment duration, duration of hospital stay and treatment complications.
RESULTS


A total of 824 babies were admitted in the neonatal care unit during the study period. Of these, 187 babies were preterm and 48 babies were recruited and randomized (25 bCPAP vs 23 oxygen). The overall survival to discharge for all eligible participants (n = 48) was 58.2% compared to those who adhered to treatment protocol (n = 45, 62.2%). Babies in the bCPAP group had higher survival (17/22; 77.3%) as compared to their counterparts in the oxygen therapy group (11/23; 47.8%). Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy. The median duration of treatment for babies in the oxygen therapy group was 2 (Range 0-16) days compared to 2 (Range 0-5) days in the bCPAP group. The median duration of hospital stay for babies receiving bCPAP was 14 (range 7-43) days. Nasal bleeding was commonly observed among babies in the bCPAP group as compared to those in the oxygen therapy group.
CONCLUSION


This study revealed that treatment with bCPAP had a 30% clinical improvement in survival to discharge. Our findings highlight the role of bCPAP in reducing neonatal mortality in resource limited settings but further adequately powered studies in this or similar settings are required.",2020,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","['conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania', '187 babies were preterm and 48 babies', 'Respiratory distress syndrome (RDS', 'preterm babies', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial', '824 babies were admitted in the neonatal care unit during the study period']","['oxygen therapy', 'bCPAP', 'Pumani bubble-CPAP versus oxygen therapy']","['Nasal bleeding', 'median duration of hospital stay', 'risk of death', 'survival to discharge', 'median duration of treatment for babies', 'treatment duration, duration of hospital stay and treatment complications', 'survival', 'neonatal mortality', 'overall survival to discharge', 'higher survival']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}]",824.0,0.182245,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","[{'ForeName': 'Annette Baine', 'Initials': 'AB', 'LastName': 'Mwatha', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mahande', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Raimos', 'Initials': 'R', 'LastName': 'Olomi', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Philemon', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}]",PloS one,['10.1371/journal.pone.0235031']
1311,32614262,A Preliminary Study of the Effects of Treatment with Lithium Versus Quetiapine on Attention of Adolescents with Bipolar Disorder.,"Objectives:  Despite attentional deficits being a prominent feature of bipolar disorder, there are limited data on the effects of common treatments for bipolar disorder on attention. Thus, we sought to compare the effects of lithium versus quetiapine on attention in adolescents with bipolar disorder.  Methods:  Adolescents ages 10-17 with bipolar disorder, type I, who were experiencing a manic or mixed episode, were recruited from outpatient settings and the inpatient psychiatric units at Cincinnati Children's Hospital Medical Center during their first manic episode. Healthy comparison subjects were recruited from outreach programs in the community. Patients were randomized to lithium or quetiapine, administered in a double-dummy, double-blinded manner for 6 weeks. Attentional deficits were assessed in all groups using the Identical Pairs Continuous Performance Task at baseline and at week 6.  Results:  Patients with bipolar disorder ( n  = 79) had impaired attention relative to the healthy group ( n  = 57) at both baseline and after 6 weeks of treatment. The lithium-treated group ( n  = 30) had poorer attentional performance than the healthy group at week 6. There was a difference in change in performance between lithium- and quetiapine-treated ( n  = 49) groups.  Conclusion:  Youth with bipolar disorder may have impaired attention relative to their healthy peers. Conclusions are limited by the high dropout rate in the lithium-treated group.",2020,There was a difference in change in performance between lithium- and quetiapine-treated ( n  = 49) groups.  ,"[""Adolescents ages 10-17 with bipolar disorder, type I, who were experiencing a manic or mixed episode, were recruited from outpatient settings and the inpatient psychiatric units at Cincinnati Children's Hospital Medical Center during their first manic episode"", 'Healthy comparison subjects were recruited from outreach programs in the community', 'Adolescents with Bipolar Disorder', 'Youth with bipolar disorder', 'adolescents with bipolar disorder', 'Patients with bipolar disorder ( n \u2009=\u200979']","['lithium versus quetiapine', 'lithium or quetiapine', 'quetiapine', 'Lithium Versus Quetiapine']","['poorer attentional performance', 'Attentional deficits']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0349208', 'cui_str': 'Manic episode, unspecified'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.137722,There was a difference in change in performance between lithium- and quetiapine-treated ( n  = 49) groups.  ,"[{'ForeName': 'Joshua V', 'Initials': 'JV', 'LastName': 'Streicher', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wen', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Tallman', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Klein', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'L Rodrigo', 'Initials': 'LR', 'LastName': 'Patino', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0169']
1312,32618713,"Antenatal Uterotonics as a Risk Factor for Intrapartum Stillbirth and First-day Death in Haryana, India: A Nested Case-control Study.","BACKGROUND


Use of uterotonics like oxytocin to induce or augment labor has been shown to reduce placental perfusion and oxygen supply to the fetus, and studies indicate that it may increase the risk of stillbirth and neonatal asphyxia. Antenatal use of uterotonics, even without the required fetal monitoring and prompt access to cesarean section, is widespread, yet no study has adequately estimated the risk of intrapartum stillbirth and early neonatal deaths ascribed to such use. We conducted a case-control study to estimate this risk.
METHODS


We conducted a population-based case-control study nested in a cluster-randomized trial. From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery. We visited all live-born infants on day 29 to ascertain whether they were alive. We conducted verbal autopsies for stillbirths and neonatal deaths. Cases (n = 2,076) were the intrapartum stillbirths and day-1 deaths (early deaths), and controls (n = 532) were live-born babies who died between day 8 and 28 (late deaths).
RESULTS


Antenatal administration of uterotonics preceded 74% of early and 62% of late deaths, translating to an adjusted odds ratio (95% confidence interval [CI]) for early deaths of 1.7 (95% CI = 1.4, 2.1), and a population attributable risk of 31% (95% CI = 22%, 38%).
CONCLUSIONS


Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death. See video abstract: http://links.lww.com/EDE/B707.",2020,"CONCLUSIONS


Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.","['From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery']",[],"['risk of intrapartum stillbirth and day-1 death', 'intrapartum stillbirths and day-1 deaths (early deaths']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.117976,"CONCLUSIONS


Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.","[{'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Brahmawar Mohan', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Sommerfelt', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'J Frederik', 'Initials': 'JF', 'LastName': 'Frøen', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Tivendra', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'van der Merwe', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Martines', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Mazumder', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001224']
1313,32618829,Magnesium Sulfate Administration in Moderate Coronary Artery Disease Patients Improves Atherosclerotic Risk Factors: A Double-Blind Clinical Trial Study.,"Magnesium (Mg) deficiency is known to promote vascular and cardiac dysfunctions such as atherosclerosis. This study investigated the effect of oral MgSO4 therapy to improve lipid profile and serum oxidized LDL level and its receptor (LOX1) in moderate coronary atherosclerotic patients. In this randomized double-blind placebo-controlled clinical trial study, 64 patients with moderate coronary artery disease were selected according to angiography findings. Participants were divided into 2 groups including Mg-treated (n = 32) and placebo (n = 32) The patients received either placebo or MgSO4 supplement capsule, containing 300 mg MgSO4 for 6 months on a daily basis. Lipid profile, HbA1c, 2h postprandial (2hpp) blood glucose, fasting blood sugar, serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), oxidized low-density lipoprotein, and lectin-like ox-LDL receptor 1 (LOX1) concentrations were measured at baseline and every 3 months. HbA1c, serum LOX1, and oxidized low-density lipoprotein concentrations were significantly lower in the Mg-treated group than the placebo group 3 months after MgSO4 administration. 2hpp, serum low-density lipoprotein cholesterol, SGPT, SGOT levels, and HbA1c levels significantly improved in the Mg-treated group compared with the placebo-received group. Overall, the results of this study showed that magnesium treatment improved some of the major risk factors of atherosclerosis. According to the results of liver function tests (SGOT and SGPT), magnesium therapy seems to be safe in patients with moderate atherosclerotic plaque. Therefore, it is suggested that magnesium to be used along with other atherosclerosis control drugs.",2020,"HbA1c, serum LOX1 and oxLDL concentrations were significantly lower in Mg-treated than placebo group three months after MgSO4 administration.","['sixty-four patients with moderate coronary artery disease were selected according to angiography findings', 'moderate coronary atherosclerotic patients', 'patients with moderate atherosclerotic plaque', 'Moderate Coronary Artery Disease Patients Improves Atherosclerotic Risk Factors']","['oral MgSO4 therapy', 'Magnesium Sulfate Administration', 'placebo or MgSO4 supplement capsule containing 300 mg MgSO4', 'Magnesium (Mg) deficiency', 'Mg-treated (n=32) and placebo(n=32 ', 'magnesium', 'placebo']","['Lipid profile, HbA1c, 2h postprandial (2hpp) blood glucose, fasting blood sugar (FBS), serum SGOT, SGPT, ox-LDL and lectin-like ox-LDL receptor 1(LOX1) concentrations', 'HbA1c, serum LOX1 and oxLDL concentrations', 'serum LDL-C, SGPT, SGOT levels and HbA1c levels', 'lipid profile and serum oxidized LDL (oxLDL) level and its receptor (LOX1', 'major risk factors of atherosclerosis']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0024473', 'cui_str': 'Magnesium deficiency'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0023206', 'cui_str': 'Lectin'}, {'cui': 'C0536243', 'cui_str': 'Oxidized LDL Receptor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",64.0,0.22722,"HbA1c, serum LOX1 and oxLDL concentrations were significantly lower in Mg-treated than placebo group three months after MgSO4 administration.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Farshidi', 'Affiliation': 'Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ali R', 'Initials': 'AR', 'LastName': 'Sobhani', 'Affiliation': 'Clinical Pathology Department, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahdiye', 'Initials': 'M', 'LastName': 'Eslami', 'Affiliation': 'Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Azarkish', 'Affiliation': 'Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Eftekhar', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Keshavarz', 'Affiliation': 'Physiology Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nepton', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Physiology Department, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000874']
1314,32620716,Comparison between mesh fixation and non-fixation in patients undergoing total extraperitoneal inguinal hernia repair.,"Background


The most important advantages of laparoscopic hernia repair include less postoperative pain, good cosmetic results, and early return to daily activities. Different methods and mesh types are used in inguinal hernia repair.
Aims


The objective of this study was to evaluate the complications and recurrence rates in patients who underwent laparoscopic inguinal hernia repair with and without mesh fixation.
Subjects and Methods


A total of 183 patients who underwent total extraperitoneal (TEP) inguinal hernia repair in the general surgery clinic between January 2012 and January 2015 patients operated due to inguinoscrotal hernia and those lost to follow-up were excluded from the study. Patients were divided into two groups. Group 1 consisted of patients in whom 3D (Bard 3D Max) mesh was used and fixed with symphysis pubis absorbable tucker, while group 2 included patients without mesh fixation. All statistical analyses were performed using SPSS 22.0 statistical package software. The differences were considered statistically significant if the P value was less than 0.05.
Results


In the study, 178 patients were included. The median age was 48 years. Of all patients, 98 had right-sided, 72 left-sided, and eight bilateral hernias. The mean follow-up duration was 45 months. The demographic data between the groups were similar. Operation time was 51.82 ± 18.87 min in group 1 and 52 ± 19.92 in group 2 (P = 0.089). No statistically significant difference was found between both groups in terms of the development of early and late complications. Intraoperative complications, port-site hernia, and mortality were not seen in any patient.
Conclusion


TEP seems to be a safe and effective surgical approach in inguinal hernia treatment with acceptable operation times and postoperative results. It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.",2020,It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.,"['in the general surgery clinic between January 2012 and January 2015 patients operated due to inguinoscrotal hernia and those lost to follow-up were excluded from the study', 'patients undergoing total extraperitoneal inguinal hernia repair', 'patients who underwent', 'Of all patients, 98 had right-sided, 72 left-sided, and eight bilateral hernias', 'Subjects and Methods\n\n\nA total of 183 patients who underwent', '178 patients were included']","['mesh fixation and non-fixation', 'laparoscopic inguinal hernia repair with and without mesh fixation', 'laparoscopic hernia repair', 'total extraperitoneal (TEP) inguinal hernia repair', 'symphysis pubis absorbable tucker, while group 2 included patients without mesh fixation']","['complications and recurrence rates', 'morbidity and recurrence rates', 'Intraoperative complications, port-site hernia, and mortality', 'development of early and late complications', 'Operation time']","[{'cui': 'C3840262', 'cui_str': 'General surgery clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}, {'cui': 'C0034014', 'cui_str': 'Bone structure of pubis'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",178.0,0.0514192,It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Acar', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kabak', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Tolan', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Canbak', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_398_19']
1315,32620717,The effect of different mouthwashes on bacteremia after debonding.,"Objectives


This study aims to investigate the effects of various mouthwashes on bacteremia development following a debonding process, which is performed after orthodontic treatment.
Subjects and Methods


The study included patients who received fixed orthodontic treatment and were indicated for debonding. A total of 40 patients in four groups were selected for the study; no mouthwash (Group 1), mouthwash containing 0.12% chlorhexidine-gluconate (Group 2), mouthwash containing essential-oils (Group 3), and mouthwash containing 7.5% povidone-iodine (Group 4). Before (T 0 ) and following (T 1 ) the debonding procedure, blood samples were obtained from the patients. Then, the blood samples were placed in blood culture bottles to investigate bacterial growth.
Results


Based on the results of the study, it was determined that the blood samples obtained at T 0 did not indicate any bacterial growth. Furthermore, it was observed that the blood samples obtained at T 1 included Streptococcus viridans, Streptococcus oralis, Streptococcus mutans, and Staphylococcus aereus growth, respectively, in 4 patients from Group 1 while Streptococcus salivarius growth was observed in 1 patient from Group 3 in addition to Streptococcus mitis growth in 1 patient from Group 4. No bacterial growth was observed in Group 2. While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups.
Conclusions


Finally, it was determined that the mouthwash 0.12% chlorhexidine-gluconate was statistically significant in comparison to the control group. It can be concluded that this mouthwash can be used to decrease bacterial density in oral flora before debonding procedures.",2020,"While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups.
","['Subjects and Methods', '40 patients in four groups were selected for the study; no mouthwash (Group 1']","['mouthwash containing 0.12% chlorhexidine-gluconate', 'chlorhexidine-gluconate', 'mouthwash containing essential-oils (Group 3), and mouthwash containing 7.5% povidone-iodine', 'fixed orthodontic treatment']","['bacteremia', 'bacterial growth', 'Streptococcus salivarius growth', 'bacteremia development']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",40.0,0.0236568,"While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups.
","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akbulut', 'Affiliation': 'Department of Orthodontics, Fırat University, Elazıǧ, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_664_19']
1316,32621918,Dexmedetomidine pretreatment attenuates myocardial ischemia reperfusion induced acute kidney injury and endoplasmic reticulum stress in human and rat.,"BACKGROUND


Patients undergoing cardiopulmonary bypass (CPB) often develop acute kidney injury (AKI) caused by myocardial ischemia reperfusion (MI/R), and this renal injury can be resolved notably by dexmedetomidine. Endoplasmic reticulum (ER) stress was reported to get involved in organ injury including AKI.
OBJECTIVES


The current study aimed to address the correlation between MI/R induced AKI with ER stress and to assess the effects of dexmedetomidine pretreatment on AKI protection.
METHOD


Patients selected for heart valve replacement surgery were randomly assigned to NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine). Rat MI/R model was induced by occluding coronary artery for 30 min followed by 48-hour reperfusion. Rats were randomized into Sham (0.9% NaCl), I/R (MI/R + 0.9% NaCl) and I/R + DEX (MI/R + dexmedetomidine). Organ function and ER stress condition were evaluated by blood chemistry, pathology, and molecular test.
RESULTS


Clinical data indicated dexmedetomidine pretreatment attenuated AKI and oxidative stress as well as postischemic myocardial injury in patients. Accordingly animal results suggested dexmedetomidine reduced cellular injury and improved postischemic myocardial and renal function. Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
CONCLUSIONS


These results suggested that dexmedetomidine pretreatment attenuates MI/R injury-induced AKI by relieving the ER stress.",2020,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","['Patients undergoing', 'Patients selected for heart valve replacement surgery', 'human and rat']","['cardiopulmonary bypass (CPB', 'NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine', 'Dexmedetomidine', '\u202fDEX (MI/R\u202f+\u202fdexmedetomidine', 'dexmedetomidine']","['MI/R injury-induced AKI', 'Endoplasmic reticulum (ER) stress', 'AKI and oxidative stress', 'myocardial and renal cells apoptosis and down-regulated ER stress', 'cellular injury and improved postischemic myocardial and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0014239', 'cui_str': 'Endoplasmic reticulum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0396497,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: chaolt@ustc.edu.cn.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02144, USA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency, Huashan Hospital North, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Xinghan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Laboratory, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230000, Anhui, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: xiaoqingchai@163.com.'}]",Life sciences,['10.1016/j.lfs.2020.118004']
1317,32628146,The ISCHEMIA trial: Implications for non-invasive imaging.,"Coronary artery disease (CAD) is highly prevalent and constitutes the single most common cause of death worldwide. However, the diagnosis of CAD remains challenging. There are two ways to approach the diagnosis of CAD, namely (1) by a functional non-invasive stress test to detect ischemia (stress echocardiography, stress cardiovascular magnetic resonance, single-photon emission computed tomography, positron emission tomography) or (2) by imaging for stenosis visualization (coronary computed tomography angiography or invasive coronary angiography). There are also two approaches for treatment: medical treatment and revascularization. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial investigated the outcome differences of patients who had moderate to severe ischemia on stress testing and who, after CT angiography, had ruled out left main stenosis and demonstrated at least 1 coronary artery stenosis exceeding 50%. The patients were randomized to an initially conservative treatment versus immediate revascularization. No difference in hard outcomes was found, but angina relief was more effective in the revascularization group. In this article, we explore the implications of the ISCHEMIA trial for non-invasive testing in suspected CAD.",2020,"No difference in hard outcomes was found, but angina relief was more effective in the revascularization group.","['patients who had moderate to severe ischemia on stress testing and who, after CT angiography, had ruled out left main stenosis and demonstrated at least 1 coronary artery stenosis exceeding 50']","['Medical and Invasive Approaches (ISCHEMIA', 'imaging for stenosis visualization (coronary computed tomography angiography or invasive coronary angiography', 'initially conservative treatment versus immediate revascularization']",['angina relief'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",,0.049503,"No difference in hard outcomes was found, but angina relief was more effective in the revascularization group.","[{'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Rakisheva', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Marwan', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Friedrich Alexander University Erlangen-Nürnberg (FAU); Erlangen-Germany.'}]",Anatolian journal of cardiology,['10.14744/AnatolJCardiol.2020.82428']
1318,32623402,"Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND


Probiotics use has been associated with modulation of inflammation and considered as a possible intervention for CNS diseases such as mild cognitive impairment (MCI) and dementia.
OBJECTIVE


We aimed to test the effect of the probiotic strain, Bifidobacterium breve A1 (MCC1274), to restore cognition in a physically healthy, suspected MCI population.
METHODS


In this randomized, double-blind, placebo-controlled trial, 80 healthy older adults suffering from MCI were divided into two even groups to receive once daily either probiotic (B. breve A1, 2×1010 CFU) or placebo for 16 weeks using a computer-generated algorithm. Cognitive functions were assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests before and after the study as primary and secondary endpoints, respectively.
RESULTS


79 participants completed the study, and no adverse events were observed. RBANS total score was significantly improved in probiotic group compared with placebo (mean between-group difference 11.3 [95% CI 6.7 to 15.8]; p < 0.0001) after 16 weeks of consumption, in particular with significant improvement in domain scores of immediate memory, visuospatial/constructional, and delayed memory (p < 0.0001), in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis. JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
CONCLUSION


Study results indicate B. breve A1 is a safe and effective approach for improving memory functions of suspected MCI subjects.",2020,"JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
","['suspected MCI subjects', 'physically healthy, suspected MCI population', '80 healthy older adults suffering from MCI', 'Older Adults with Suspected Mild Cognitive Impairment']","['Placebo', 'Probiotic Bifidobacterium breve', 'probiotic strain, Bifidobacterium breve A1 (MCC1274', 'probiotic (B. breve A1, 2×1010 CFU) or placebo', 'placebo']","['Cognitive functions', 'JMCIS score', 'Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests', 'Cognitive Functions', 'domain scores of immediate memory, visuospatial/constructional, and delayed memory', 'RBANS total score']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0376364', 'cui_str': 'Delayed Memory'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",80.0,0.666455,"JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).
","[{'ForeName': 'Jinzhong', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Katsumata', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bernier', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ohno', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamauchi', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Odamaki', 'Affiliation': 'Morinaga Milk Industry Co., Ltd., Next Generation Science Institute, Kanagawa, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Huma R & D Co. Ltd, Tokyo, Japan.'}, {'ForeName': 'Kumie', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Nihonbashi Sakura Clinic, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, Tokyo, Japan.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200488']
1319,32632523,Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity.,"BACKGROUND


Due to the SARS-CoV2 pandemic, medical face masks are widely recommended for a large number of individuals and long durations. The effect of wearing a surgical and a FFP2/N95 face mask on cardiopulmonary exercise capacity has not been systematically reported.
METHODS


This prospective cross-over study quantitated the effects of wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask (ffpm) in 12 healthy males (age 38.1 ± 6.2 years, BMI 24.5 ± 2.0 kg/m 2 ). The 36 tests were performed in randomized order. The cardiopulmonary and metabolic responses were monitored by ergo-spirometry and impedance cardiography. Ten domains of comfort/discomfort of wearing a mask were assessed by questionnaire.
RESULTS


The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± 1.6 l/s; p < 0.001). The maximum power was 269 ± 45, 263 ± 42 and 277 ± 46 W with sm, ffpm and nm, respectively; p = 0.002; the ventilation was significantly reduced with both face masks (131 ± 28 vs 114 ± 23 vs 99 ± 19 l/m; p < 0.001). Peak blood lactate response was reduced with mask. Cardiac output was similar with and without mask. Participants reported consistent and marked discomfort wearing the masks, especially ffpm.
CONCLUSION


Ventilation, cardiopulmonary exercise capacity and comfort are reduced by surgical masks and highly impaired by FFP2/N95 face masks in healthy individuals. These data are important for recommendations on wearing face masks at work or during physical exercise.",2020,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","['12 healthy males (age 38.1\u2009±\u20096.2\xa0years, BMI 24.5\u2009±\u20092.0\xa0kg/m 2 ', 'healthy individuals']","['wearing a surgical and a FFP2/N95 face mask', 'wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask', 'surgical and FFP2/N95 face masks']","['Cardiac output', 'Peak blood lactate response', 'ventilation', 'pulmonary function parameters', 'cardiopulmonary exercise capacity', 'cardiopulmonary and metabolic responses']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",12.0,0.0184074,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Fikenzer', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany. sven.fikenzer@medizin.uni-leipzig.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Uhe', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lavall', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rudolph', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hepp', 'Affiliation': 'Klinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01704-y']
1320,32650729,Testing the regulatory framework in South Africa - a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis.,"BACKGROUND


Bacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment.
METHODS


Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7-10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment.
RESULTS


The  South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24-1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product.
CONCLUSION


Navigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered.
TRIAL REGISTRATION


This trial was registered on 17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ).",2020,"Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules.","['Women with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs', 'women with bacterial vaginosis', 'vaginal health in South Africa', '17 October 2017 with the South African National Clinical Trial Register ( http://www.sanctr.gov.za/ ; BV-trial1; DOH-27-1117-5579 ', 'BV+ (Nugent 7-10) but STI- women']","['commercial probiotic supplementation', 'metronidazole followed by a commercial oral/vaginal probiotic', 'commercial oral-vaginal-combination probiotic', 'vaginal metronidazole alone']","['BV recurrence, symptoms, vaginal microbiota and genital cytokine changes', 'BV cure', 'Acceptability and adherence', 'acceptability of vaginal application', 'recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations', 'HIV risk and adverse reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}]","[{'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.359196,"Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules.","[{'ForeName': 'Anna-Ursula', 'Initials': 'AU', 'LastName': 'Happel', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa. anna.happel@uct.ac.za.'}, {'ForeName': 'Ravesh', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Nireshni', 'Initials': 'N', 'LastName': 'Mitchev', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Koleka', 'Initials': 'K', 'LastName': 'Mlisana', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of Kwa-Zulu Natal, Durban, South Africa.'}, {'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Jaspan', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Shaun L', 'Initials': 'SL', 'LastName': 'Barnabas', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}, {'ForeName': 'Jo-Ann S', 'Initials': 'JS', 'LastName': 'Passmore', 'Affiliation': 'Division of Medical Virology, Faculty of Health Sciences, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Anzio Road, Observatory, Cape Town, 7925, South Africa.'}]",BMC infectious diseases,['10.1186/s12879-020-05210-4']
1321,32656869,Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.,"BACKGROUND


Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs.
AIM


To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn.
METHODS


A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients had moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient.
RESULTS


Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups.
CONCLUSION


This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief or consumption of PPIs. ClinicalTrials.gov NCT01682265.",2020,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","['patients with PPI-refractory heartburn', 'PPI non-responding patients with heartburn', 'patients with gastro-oesophageal reflux disease responding to PPIs']","['oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn', 'oesophageal radiofrequency', 'proton pump inhibitors (PPIs']","['moderate-to-severe heartburn', 'occurrence of adverse events', 'number of days without heartburn, days with PPI consumption', 'clinical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",62.0,0.307362,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Sacher-Huvelin', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coron', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Melchior', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ponchon', 'Affiliation': 'Gastroenterology Department, CHU de Lyon, Hôpital Edouard Herriot, Université de Lyon, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Chabrun', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Vavasseur', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gorbatchef', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zalar', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mion', 'Affiliation': 'Digestive Physiology Department, Hospices Civils de Lyon, Université de Lyon, Inserm U1082 LabTau, Lyon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Robaszkiewicz', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Le Rhun', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Methodology and Biostatistics Department, CHU de Nantes, Université de Nantes, Nantes, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paul Galmiche', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Bruley des Varannes', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15936']
1322,32657029,"Raltitrexed versus 5-fluorouracil with cisplatin and concurrent radiotherapy for locally advanced nasopharyngeal carcinoma: An open labeled, randomized, controlled, and multicenter clinical trial.","BACKGROUND


This study aimed to compare the efficacy and toxicity of raltitrexed (Saiweijian ®  ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen) as concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).
METHODS


Eligible patients (N = 135) were allocated randomly in a ratio of 1:1 to receive CCRT with either SP or FP. At least 2 cycles of chemotherapy was administrated during radiotherapy. Progression free survival (PFS) was primary endpoint. Secondary endpoints included overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity.
RESULTS


In this study, 68 patients received SP as CCRT, and 67 received FP. Objective responses were noted in 97.1% of the patients in the SP group and in 97.0% of the patients in the FP group (P = 1.00). At the end of a median 36 months follow-up period, the estimated 3-year PFS rates were 70.1% for SP and 66.6% for FP, respectively. The 3-year LRRFS, DMFS and OS rates were 88.9%, 74.7% and 84.0%, respectively, for the SP group, and 92.3%, 71.0% and 73.7%, respectively, for the FP group. Overall, there was no difference between treatment groups with regard to response or survival. The most frequent acute toxicities monitored in both groups were bone marrow suppression, gastrointestinal side effects and oral mucositis (OM). The overall incidence of grade 3-4 OM in the FP group (47.8%) was higher than in the SP group (11.8%). However, the incidence of other adverse effects observed in both groups was similar (P > .05).
CONCLUSIONS


These data indicate that SP and FP therapies have similar efficacy in treating LA-NPC. The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality. In conclusion, SP was a well tolerated, effective, regimen for LA-NPC treatment.",2020,"The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality.","['locally advanced nasopharyngeal carcinoma', 'Eligible patients (N\xa0=\xa0135', 'patients with locally advanced nasopharyngeal carcinoma (LA-NPC', '68 patients received SP as CCRT, and 67 received']","['raltitrexed (Saiweijian ®  ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen', 'CCRT with either SP or FP', 'FP', 'Raltitrexed versus 5-fluorouracil with cisplatin and concurrent radiotherapy', 'chemotherapy', 'chemoradiotherapy (CCRT']","['acute toxicities', 'incidence of other adverse effects', '3-year PFS rates', 'response or survival', '3-year LRRFS, DMFS and OS rates', 'efficacy and toxicity', 'overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity', 'tolerable safety profile', 'bone marrow suppression, gastrointestinal side effects and oral mucositis (OM', 'life quality', 'overall incidence of grade 3-4 OM', 'Progression free survival (PFS', 'Objective responses']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",135.0,0.0930863,"The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality.","[{'ForeName': 'Pengwei', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Radiotherapy, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Shengfu', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Bian', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feijiang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Fuzheng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Cancer Institute of Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hongping', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Director of Department of Radiotherapy Oncology, Nanjing Benq Medicalcenter, Nanjing, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}]",Cancer medicine,['10.1002/cam4.3260']
1323,32654580,A Randomized Double-Blind Placebo-Control Study to Assess the Efficacy and Safety of OLNP-05 Versus Placebo for the Treatment of Subjects with Premature Ejaculation.,"Premature ejaculation (PE) is one of the foremost sex-related health problems among men. The global occurrence ranges from 20% to 30%, according to various studies. PE has a great impact on the men's quality of life, with deleterious effects such as embarrassment, frustration, and feeling of incompetence. Considering the necessity of treatment of PE, this study was planned to compare the efficacy and safety of OLNP-05 versus placebo for treating subjects suffering from PE. In this randomized clinical study, 60 men with PE were enrolled and randomly assigned to receive either OLNP-05 or placebo one capsule twice daily for a period of 8 weeks. Subjects were evaluated during visits on day 1, day 28, and day 56. Mean change from baseline in intravaginal ejaculatory latency time (IELT), improvement in premature ejaculation profile (PEP), and Clinical Global Impression-Improvement scale (CGI-I) were used to assess the efficacy of treatment.  P -value <.05 was considered significant. At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo. Subjects in the OLNP-05 treatment group also reported significantly greater improvement in PEP subscale score. Majority of OLNP-05-treated subjects were found to be in the ""much improved"" category as per CGI-I assessment. The result confirms the safety and efficacy of OLNP-05, therefore suggesting that OLNP-05 may be a safe and effective intervention for the management of PE.  Trial registration:  Clinical Trials Registry India (Registration No: CTRI/2017/08/009226, 02/08/2017).",2020,"At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo.","['Subjects with Premature Ejaculation', '60 men with PE', 'subjects suffering from PE']","['OLNP-05 versus placebo', 'Placebo', 'OLNP-05 or placebo', 'OLNP-05', 'PE', 'placebo']","['PEP subscale score', 'efficacy and safety', 'Premature ejaculation (PE', 'IELT score', 'intravaginal ejaculatory latency time (IELT), improvement in premature ejaculation profile (PEP), and Clinical Global Impression-Improvement scale (CGI-I']","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",60.0,0.168967,"At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo.","[{'ForeName': 'Sanjib Kumar', 'Initials': 'SK', 'LastName': 'Panda', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}, {'ForeName': 'Somashekara', 'Initials': 'S', 'LastName': 'Nirvanashetty', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}, {'ForeName': 'Vivek A', 'Initials': 'VA', 'LastName': 'Parachur', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}, {'ForeName': 'Nilima', 'Initials': 'N', 'LastName': 'Mohanty', 'Affiliation': 'Olene Life Sciences Private Limited, Chennai, India.'}]",Journal of medicinal food,['10.1089/jmf.2019.4661']
1324,32658797,Addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia improves analgesic efficacy after tonsillectomy and adenoidectomy: A randomized controlled trial.,"OBJECTIVES


The aim of this study was to determine whether the addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia was more effective than ropivacaine alone in attenuating pain after tonsillectomy and adenoidectomy.
METHODS


This was a double-blind randomized clinical trial. One hundred and twenty children scheduled for tonsillectomy and adenoidectomy using a combination of general anaesthesia and local infiltration anaesthesia were randomized into the dexmedetomidine plus ropivacaine group (DR) and ropivacaine group (R). The children were locally infiltrated with 1 μg kg -1  dexmedetomidine and 0.25% ropivacaine in the DR group or 0.25% ropivacaine alone in the R group. In both groups, local infiltration anaesthesia was performed using 5 ml of solution. The pain scores were recorded at the 1st, 4th, 8th, 12th, 16th, 20th, and 24th hours after surgery using the Face Legs Activity Cry Consolability (FLACC) scale. When the pain score exceeded 4, paracetamol syrup (15 mg kg -1 ) was administered as a rescue analgesic. Time to the first administration of analgesic was recorded.
RESULTS


8th, 16th, 20th, and 24th hours after surgery, the children in the DR group had lower pain scores than those in the R group (P<0.05). The time to the first administration of analgesic was significantly longer in the DR group (mean: 10.4 h, range: 9.4-11.4 h) than in the R group (mean: 8.1 h, range: 7.3-8.8 h) (P < 0.001).
CONCLUSION


The addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia effectively improved the efficacy of analgesia and extended the duration of analgesia after tonsillectomy and adenoidectomy.",2020,The addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia effectively improved the efficacy of analgesia and extended the duration of analgesia after tonsillectomy and adenoidectomy.,['One hundred and twenty children scheduled for tonsillectomy and adenoidectomy using a combination of general anaesthesia and local infiltration anaesthesia'],"['dexmedetomidine plus ropivacaine', 'tonsillectomy and adenoidectomy', 'ropivacaine', 'paracetamol syrup', 'dexmedetomidine']","['pain scores', 'Face Legs Activity Cry Consolability (FLACC) scale', 'efficacy of analgesia and extended the duration of analgesia', 'time to the first administration of analgesic', 'analgesic efficacy', 'pain', 'pain score', 'lower pain scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",120.0,0.171204,The addition of dexmedetomidine to ropivacaine for local infiltration anaesthesia effectively improved the efficacy of analgesia and extended the duration of analgesia after tonsillectomy and adenoidectomy.,"[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China.""}, {'ForeName': 'Zanqing', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China.""}, {'ForeName': 'Zhenguo', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China.""}, {'ForeName': 'Buhuai', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': ""Department of Anesthesiology, HongHui Hospital, Xi'an JiaoTong University, Xi'an, China. Electronic address: dongbuhai@sina.com.""}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110168']
1325,32660725,Pregnancy and neonatal outcomes 42 months after application of hyaluronic acid gel following dilation and curettage for miscarriage in women who have experienced at least one previous curettage: follow-up of a randomized controlled trial.,"OBJECTIVE


To study whether intrauterine application of auto-crosslinked polymers of hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive outcomes.
DESIGN


Follow-up of a prospective randomized trial.
SETTING


University and university-affiliated teaching hospitals.
PATIENT(S)


Women with a miscarriage at <14 weeks' gestation with at least one previous D&C were randomized to D&C plus ACP gel (intervention) or D&C alone (control). A hysteroscopy was performed after 8-12 weeks, and if intrauterine adhesion (IUAs) were encountered, adhesiolysis was executed.
INTERVENTION(S)


Participants received a questionnaire 30 months after treatment.
MAIN OUTCOME MEASURE(S)


Ongoing pregnancy and outcome of subsequent pregnancies.
RESULT(S)


Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive. The median times to conception leading to a live birth were, respectively, 21.9 versus 36.1 months. Reduced menstrual blood loss was reported in 7.5% (5/67) versus 20.3% (13/64) and dysmenorrhea in 14.9% (10/67) versus 34.4% (22/64), respectively.
CONCLUSION(S)


Application of ACP gel following D&C performed after miscarriage seems to have a favorable effect on subsequent reproductive outcomes in women with at least one previous D&C. Given the fact that the study was not powered for reproductive outcomes, the data should be interpreted with caution. The effect may be underestimated due to routine removal of IUAs.
DUTCH CLINICAL TRIAL REGISTRY NUMBER


NTR 3120.",2020,"Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive.","['University and university-affiliated teaching hospitals', ""\n\n\nWomen with a miscarriage at <14 weeks' gestation with at least one previous D&C"", 'women who have experienced at least one previous curettage', 'women with at least one previous D&C']","['hyaluronic acid (ACP) gel after dilation and curettage (D&C', 'ACP gel', 'hyaluronic acid gel', 'D&C plus ACP gel (intervention) or D&C alone (control', 'dilation and curettage']","['menstrual blood loss', 'median times to conception leading to a live birth', 'dysmenorrhea']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0012358', 'cui_str': 'Dilation and curettage of uterus'}, {'cui': 'C0968234', 'cui_str': 'auto-cross-linked polysaccharide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",,0.185464,"Ongoing pregnancies were recorded in 74.6% (50/67) of the intervention group versus 67.2% (43/64) of the control group, and in, respectively, 94.3% (50/53) versus 71.7% (43/60) in the women wishing to conceive.","[{'ForeName': 'Angelo B', 'Initials': 'AB', 'LastName': 'Hooker', 'Affiliation': 'Department of Obstetrics and Gynecology, Zaans Medical Center, Zaandam, the Netherlands; Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands. Electronic address: hooker.a@zaansmc.n.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hans A M', 'Initials': 'HAM', 'LastName': 'Brölmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynecology, Amsterdam University Medical Center, Vrije Universiteit Medical Center, Amsterdam, the Netherlands.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.04.021']
1326,32614361,"The Efficacy of a Dietary Supplement with Carnosine and Hibiscus Sabdariffa L. (AqualiefTM) in Patients with Xerostomia: a Randomized, Placebo-Controlled, Double-Blind Trial.","The purpose of this study was to test the safety and efficacy of AqualiefTM in patients affected by xerostomia. The main ingredients of AqualiefTM are carnosine and dried calyces of Hibiscus sabdariffa L. (karkadè) for their buffering effect at pH 7 as well as for their antioxidant, antimicrobial and lenitive properties. In a Randomized, Placebo-Controlled, Double-Blind Trial, sixty patients with xerostomia (RTOG/EORTC grade 1-2) were randomly assigned to receive either placebo, or AqualiefTM tablets (three times/day after meals) for 6 consecutive days. A questionnaire was used to evaluate dry mouth symptoms before and after 6 days of AqualiefTM or placebo application. Unstimulated and stimulated salivary flow rates and pH were measured before and after application. Treatment with AqualiefTM for 6 days induced a significant increase in saliva pH from 6.2 ± 0.5 to 6.4 ± 0.6 (P < 0.05) while placebo was ineffective (from 6.2 ± 0.5 to 6.3 ± 0.5). AqualiefTM also induced a significant increase in the pH of stimulated saliva from 6.3 ± 0.5 to 6.6 ± 0.5 (P < 0.01). Placebo was ineffective also in this setting (from 6.2 ± 0.5 to 6.3 ± 0.5). Besides an expected normalization of the saliva pH value, AqualiefTM treatment for 6 days greatly increased (56%, P < 0.0001) saliva production. Placebo induced a 19% increase (P < 0.05), which was likely due to mechanical stimulation. AqualiefTM also increased stimulated saliva production (27% increase with respect to day 0, P < 0.05), while placebo was ineffective. AqualiefTM was effective in regulating the saliva pH, in increasing saliva production and improving dry mouth symptoms in xerostomic patients.",2020,"AqualiefTM was effective in regulating the saliva pH, in increasing saliva production and improving dry mouth symptoms in xerostomic patients.","['Patients with Xerostomia', 'patients affected by xerostomia', 'xerostomic patients', 'sixty patients with xerostomia (RTOG/EORTC grade 1-2']","['placebo, or AqualiefTM tablets', 'Placebo', 'Dietary Supplement with Carnosine and Hibiscus Sabdariffa L. (AqualiefTM', 'placebo']","['safety and efficacy of AqualiefTM', 'stimulated saliva production', 'saliva pH value', 'saliva pH', 'saliva production and improving dry mouth symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C1207898', 'cui_str': 'Roselle'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.435261,"AqualiefTM was effective in regulating the saliva pH, in increasing saliva production and improving dry mouth symptoms in xerostomic patients.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Levrini', 'Affiliation': 'Department of Surgical and Morphological Sciences, Dental Hygiene School, University of Insubria, Varese.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Azzi', 'Affiliation': 'Department of Surgical and Morphological Sciences, Dental Hygiene School, University of Insubria, Varese.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bossi', 'Affiliation': 'Private pratice.'}]",La Clinica terapeutica,['10.7417/CT.2020.2231']
1327,32614368,Awake fiberoptic intubation in patients with stenosis of the upper airways: Utility of the laryngeal nerve block.,"Awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways. Superior laryngeal nerve block (SLNB) could reduce risks and improve patient comfort. The aim of this study is to assess the procedural comfort of SLNB during AFOI in a population of patients undergoing upper airway oncological surgery. Forty patients were randomized into two groups and were treated with continuous infusion of remifentanil, topic anesthesia and intercricoid block. In the study group (=20), SLNB was performed with lidocaine (L-SLNB); in the control group (n=20) SLNB was performed using saline (S-SLNB). AFOI was more comfortable in the L-SLNB group compared to S-SLNB patients [FOICS ≤ 1 in 18 patients (90%) L-SLNB; 2 (10%) S-SLNB (P <0.001)]. Intubation was faster in L-SLNB (47.45 ±15.38 sec) than S-SLNB (80.15 ±37.91 sec) (p <0.001). The SLNB procedure during AFOI is a safe and comfortable procedure in a population of patients undergoing upper airways surgery. Time to intubation was shorter in L-SLNB than in S-SLNB.",2020,Intubation was faster in L-SLNB (47.45 ±15.38 sec) than S-SLNB (80.15 ±37.91 sec) (p <0.001).,"['patients undergoing upper airways surgery', 'Forty patients', 'patients with stenosis of the upper airways', 'patients undergoing upper airway oncological surgery']","['Awake fiberoptic intubation', 'lidocaine (L-SLNB', 'Awake fiberoptic intubation (AFOI', 'Superior laryngeal nerve block (SLNB', 'remifentanil, topic anesthesia and intercricoid block', 'SLNB']","['Time to intubation', 'AFOI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0394817', 'cui_str': 'Local anesthetic superior laryngeal nerve block'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]",40.0,0.0565902,Intubation was faster in L-SLNB (47.45 ±15.38 sec) than S-SLNB (80.15 ±37.91 sec) (p <0.001).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Alessandri', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bellucci', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tellan', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pinchera', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buonopane', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Department of Sense Organs, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Vincentiis', 'Affiliation': 'Department of oral and maxillofacial sciences, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pugliese', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bilotta', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}]",La Clinica terapeutica,['10.7417/CT.2020.2236']
1328,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
1329,32628258,Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial.,"Importance


Standardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.
Objective


To test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.
Design, Setting, and Participants


The Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.
Interventions


Five 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.
Main Outcomes and Measures


Twelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.
Results


The study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).
Conclusions and Relevance


This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.
Trial Registration


ClinicalTrials.gov Identifier: NCT02612688.",2020,"This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness.","['Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations', 'Long-Stay Nursing Home Residents', '4171 residents with advanced illness (21.9%) viewed ACP videos', '4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11\u202f773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years', 'Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11\u202f773 long-stay residents without advanced illness in the control group', 'long-stay residents with or without advanced illness', 'long-stay nursing home residents with and without advanced illness']","['advance care planning (ACP', 'Video Education', 'Advance Care Planning Video Intervention', 'ACP video program']","['proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment', 'hospital transfers, burdensome treatments, and hospice enrollment', 'hospital transfers', 'hospital transfers per 1000 person-days alive in the advanced illness cohort', 'Facility-level rates of showing ACP videos']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",4171.0,0.160497,"This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness.","[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Roee', 'Initials': 'R', 'LastName': 'Gutman', 'Affiliation': 'Department of Biostatistics, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Gozalo', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Ogarek', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Ruoshui', 'Initials': 'R', 'LastName': 'Zhai', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Center for Gerontology and Healthcare Research, Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, Rhode Island.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2366']
1330,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1331,32631074,"Utility of Neuromuscular Electrical Stimulation to Preserve Quadriceps Muscle Fiber Size and Contractility After Anterior Cruciate Ligament Injuries and Reconstruction: A Randomized, Sham-Controlled, Blinded Trial.","BACKGROUND


Anterior cruciate ligament (ACL) injuries and reconstruction (ACLR) promote quadriceps muscle atrophy and weakness that can persist for years, suggesting the need for more effective rehabilitation programs. Whether neuromuscular electrical stimulation (NMES) can be used to prevent maladaptations in skeletal muscle size and function is unclear.
PURPOSE


To examine whether early NMES use, started soon after an injury and maintained through 3 weeks after surgery, can preserve quadriceps muscle size and contractile function at the cellular (ie, fiber) level in the injured versus noninjured leg of patients undergoing ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 1.
METHODS


Patients (n = 25; 12 men/13 women) with an acute, first-time ACL rupture were randomized to NMES (5 d/wk) or sham (simulated microcurrent electrical nerve stimulation; 5 d/wk) treatment to the quadriceps muscles of their injured leg. Bilateral biopsies of the vastus lateralis were performed 3 weeks after surgery to measure skeletal muscle fiber size and contractility. Quadriceps muscle size and strength were assessed 6 months after surgery.
RESULTS


A total of 21 patients (9 men/12 women) completed the trial. ACLR reduced single muscle fiber size and contractility across all fiber types ( P  < .01 to  P  < .001) in the injured compared with noninjured leg 3 weeks after surgery. NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001). NMES preserved contractility in slow-twitch MHC I fibers ( P  < .01 to  P  < .001), increasing maximal contractile velocity ( P  < .01) and preserving power output ( P  < .01), but not in MHC II fibers. Differences in whole muscle strength between groups were not discerned 6 months after surgery.
CONCLUSION


Early NMES use reduced skeletal muscle fiber atrophy in MHC II fibers and preserved contractility in MHC I fibers. These results provide seminal, cellular-level data demonstrating the utility of the early use of NMES to beneficially modify skeletal muscle maladaptations to ACLR.
CLINICAL RELEVANCE


Our results provide the first comprehensive, cellular-level evidence to show that the early use of NMES mitigates early skeletal muscle maladaptations to ACLR.
REGISTRATION


NCT02945553 (ClinicalTrials.gov identifier).",2020,NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001).,"['Patients (n = 25; 12 men/13 women) with an acute, first-time ACL rupture', '21 patients (9 men/12 women) completed the trial', 'After Anterior Cruciate Ligament Injuries and Reconstruction']","['Anterior cruciate ligament (ACL) injuries and reconstruction (ACLR', 'neuromuscular electrical stimulation (NMES', 'Neuromuscular Electrical Stimulation', 'NMES (5 d/wk) or sham (simulated microcurrent electrical nerve stimulation; 5 d/wk) treatment to the quadriceps muscles of their injured leg']","['maximal contractile velocity', 'preserving power output', 'Quadriceps Muscle Fiber Size and Contractility', 'ACLR reduced single muscle fiber size and contractility', 'Quadriceps muscle size and strength', 'fast-twitch myosin heavy chain (MHC) II fibers', 'contractility in slow-twitch MHC', 'muscle fiber atrophy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0027100', 'cui_str': 'Myosin Heavy Chain'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}, {'cui': 'C0333751', 'cui_str': 'Muscle fiber atrophy'}]",21.0,0.154142,NMES reduced muscle fiber atrophy ( P  < .01) through effects on fast-twitch myosin heavy chain (MHC) II fibers ( P  < .01 to  P  < .001).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Toth', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Tourville', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Voigt', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Choquette', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Anair', 'Affiliation': 'Department of Medicine, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Failla', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Stevens-Lapslaey', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Colorado, Denver, Colorado, USA.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'Endres', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Slauterbeck', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Beynnon', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Vermont, Burlington, Vermont, USA.'}]",The American journal of sports medicine,['10.1177/0363546520933622']
1332,32631820,Population Pharmacokinetics of Praziquantel in Pregnant and Lactating Filipino Women Infected with Schistosoma japonicum.,"An estimated 40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  spp. Treatment with praziquantel (PZQ) via mass drug administration (MDA) campaigns is the mainstay of schistosomiasis control for populations living in areas of endemicity. The World Health Organization recommends that pregnant and lactating women be included in schistosomiasis MDA programs, and several recent studies have evaluated the safety and efficacy of PZQ use during pregnancy. To date, there are no data describing PZQ pharmacokinetics (PK) during pregnancy or among lactating postpartum women. As part of a randomized controlled trial investigating the safety and efficacy of PZQ during human pregnancy, we examined the PK of this therapeutic drug among three distinct cohorts of women infected with  S. japonicum  in Leyte, Philippines. Specifically, we studied the PK properties of PZQ among early- and late-gestation pregnant women ( n  = 15 each) and lactating postpartum women ( n  = 15) with schistosomiasis. We found that women in early pregnancy had increased apparent clearance and lower area-under-the-curve (AUC 0-24 ) values that may be related to physiological changes in drug clearance and/or changes in oral bioavailability. There was no relationship between body weight and apparent clearance. The mean ± standard deviation partition ratio of plasma to breast milk was 0.36. ± 0.13. The estimated median infant PZQ daily dose would be 0.037 mg/kg of body weight ingested from breast milk, which is significantly lower than the dosage required for antischistosomal activity and not known to be harmful to the infant. Our PK data do not support the suggestion to delay breastfeeding 72 h after taking PZQ. Results can help inform future drug efficacy studies in pregnant and lactating women with schistosomiasis.",2020,There was no relationship between body weight and apparent clearance.,"['populations living in endemic areas', 'three distinct cohorts of women infected with  S. japonicum  in Leyte, The Philippines', 'among early and late gestation pregnant women (N= 15 each) and lactating post-partum women (N=15) with schistosomiasis', 'pregnant and lactating women with schistosomiasis', 'Pregnant and Lactating Filipino Women infected with  Schistosoma japonicum ', 'pregnant and lactating women', 'lactating postpartum women', '40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  ( S. ) spp']","['Praziquantel', 'praziquantel (PZQ) via mass drug administration (MDA) campaigns', 'PZQ']","['body weight and apparent clearance', 'PK properties of PZQ', 'mean ± standard deviation partition ratio of plasma to breast milk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454753', 'cui_str': 'Leyte'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036323', 'cui_str': 'Disease due to Schistosomatidae'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0036317', 'cui_str': 'Schistosoma japonicum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",,0.0915495,There was no relationship between body weight and apparent clearance.,"[{'ForeName': 'Amaya L', 'Initials': 'AL', 'LastName': 'Bustinduy', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom Amaya.Bustinduy@lshtm.ac.uk.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Mirochnick', 'Affiliation': 'Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Department of Epidemiology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'Department of Pediatrics, Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Antimicrobial Pharmacodynamics and Therapeutics, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00566-20']
1333,32639468,"A Randomized, Controlled Pharmacokinetic and Pharmacodynamics Trial of Ambrisentan After Fontan Surgery.","OBJECTIVES


To determine the pharmacokinetics, pharmacodynamics, and safety of the hepatically metabolized endothelin receptor antagonist, ambrisentan in children after Fontan surgery.
DESIGN


Prospective, randomized, double-blind, placebo-controlled pharmacokinetic/pharmacodynamics and safety trial.
SETTING


Single-center, postoperative cardiac ICU.
PATIENTS


Children undergoing elective Fontan surgery.
INTERVENTIONS


Subjects randomized on postoperative day number 1 to short-term (3 d) treatment with oral ambrisentan (2.5 mg in suspension, daily) versus placebo (4:1 randomization).
MEASUREMENTS AND MAIN RESULTS


Plasma drug concentrations were measured at 0.5, 1, 2, 4, and 18-36 hours after the first dose. We developed a population pharmacokinetic model in NONMEM 7.2 (Icon Solutions, Ellicott City, MD) and applied the model to dose-exposure simulations. Pharmacodynamics endpoints were assessed at baseline and 3 hours after study drug administration, using postoperative hemodynamic monitoring lines. The analysis included 16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males. There were no differences in baseline characteristics between ambrisentan and controls. A one-compartment model with first-order absorption and lag-time characterized the data well. Allometrically scaled weight was the only covariate retained in the final model. Typical values for clearance and volume of distribution were lower than previously reported in adults, 1 L/hr/70 kg and 13.7 L/70 kg, respectively. Simulated exposures with doses of 0.1-0.2 mg/kg approximated therapeutic exposures in adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses. Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
CONCLUSIONS


Ambrisentan clearance is reduced following Fontan surgery, perhaps reflecting abnormal hepatic metabolism in this population. The observed safety profile appears favorable and hemodynamic effects of ambrisentan may be beneficial for Fontan patients.",2020,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","['Fontan patients', 'adults with pulmonary arterial hypertension receiving 5 mg or 10 mg doses', 'children after Fontan surgery', 'Children undergoing elective Fontan surgery', 'Single-center, postoperative cardiac ICU', '16 patients, 13 on ambrisentan (77 plasma samples); median age 36 months (range, 26-72 mo), weight 13.3 kg (11.1-17.6 kg), and nine males']","['Ambrisentan', 'oral ambrisentan (2.5 mg in suspension, daily) versus placebo', 'placebo']","['Fontan pressures', 'Plasma drug concentrations', 'Typical values for clearance and volume of distribution', 'indexed pulmonary vascular resistance', 'plasma brain natriuretic peptide concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0918012', 'cui_str': 'Indexes as Topic'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}]",,0.416991,"Ambrisentan lowered plasma brain natriuretic peptide concentrations (452 ± 479 to 413 ± 462; p = 0.046), Fontan pressures (16.8 ± 2.9 to 15.6 ± 2.9; p = 0.01), and indexed pulmonary vascular resistance (2.3 ± 0.9 to 1.8 ± 0.6; p = 0.01) with no drug-related adverse events.
","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Anil R', 'Initials': 'AR', 'LastName': 'Maharaj', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thompson', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Piers C A', 'Initials': 'PCA', 'LastName': 'Barker', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Division of Pediatric Cardiology, Department of Pediatrics, Duke University Pediatric and Congenital Heart Center, Durham, NC.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002410']
1334,32639470,A Randomized Comparative Trial to Evaluate a PICU Navigator-Based Parent Support Intervention.,"OBJECTIVES


Communication breakdowns in PICUs contribute to inadequate parent support and poor post-PICU parent outcomes. No interventions supporting communication have demonstrated improvements in parental satisfaction or psychologic morbidity. We compared parent-reported outcomes from parents receiving a navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure.
DESIGN


Patient-level, randomized trial.
SETTING


Two university-based, tertiary-care children's hospital PICUs.
PARTICIPANTS


Parents of patients requiring more than 24 hours in the PICU.
INTERVENTIONS


PICU Supports included adding a trained navigator to the patient's healthcare team. Trained navigators met with parents and team members to assess and address communication, decision-making, emotional, informational, and discharge or end-of-life care needs; offered weekly family meetings; and did a post-PICU discharge parent check-in. The comparator arm received an informational brochure providing information about PICU procedures, terms, and healthcare providers.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was percentage of ""excellent"" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge. Secondary outcomes included parental psychologic and physical morbidity and perceptions of team communication. We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure. Fifty-seven percent (216/382) completed the 3-5 weeks post-PICU discharge survey. The mean percentage of excellent responses to the Pediatric Family Satisfaction in the ICU 24 decision-making items was 60.4% for PICU Supports versus 56.1% for the brochure (estimate, 3.57; SE, 4.53; 95% CI, -5.77 to 12.90; p = 0.44). Differences in secondary outcomes were not statistically significant. Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively. Differences in decision-making satisfaction scores between those receiving PICU Supports and a brochure were not statistically significant. Interventions like PICU Supports should be evaluated in larger studies employing enhanced recruitment and retention of subjects.",2020,"Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively.","['We enrolled 382 families: 190 received PICU Supports, and 192 received the brochure', ""Two university-based, tertiary-care children's hospital PICUs"", 'Parents of patients requiring more than 24 hours in the PICU']","['navigator-based parent support intervention (PICU Supports) with those from parents receiving an informational brochure', 'informational brochure providing information about PICU procedures, terms, and healthcare providers', 'PICU Navigator-Based Parent Support Intervention']","['percentage of ""excellent"" responses to the Pediatric Family Satisfaction in the ICU 24 decision-making domain obtained 3-5 weeks following PICU discharge', 'Pediatric Family Satisfaction', 'decision-making satisfaction scores', 'parental psychologic and physical morbidity and perceptions of team communication', 'parental satisfaction or psychologic morbidity']","[{'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",382.0,0.172012,"Most parents (91.1%; 113/124) described PICU Supports as ""extremely"" or ""somewhat"" helpful.
CONCLUSIONS


Parents who received PICU Supports rated the intervention positively.","[{'ForeName': 'Kelly N', 'Initials': 'KN', 'LastName': 'Michelson', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Frader', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Charleston', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rychlik', 'Affiliation': ""Stanley Manne Children's Research Institute, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Danica Y', 'Initials': 'DY', 'LastName': 'Aniciete', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Division of Biostatistics, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Sorce', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Marla L', 'Initials': 'ML', 'LastName': 'Clayman', 'Affiliation': 'Health and Social Development, American Institutes for Research, Chicago, IL.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': ""Department of Pediatrics, Section of Critical Care, The University of Chicago Comer Children's Hospital, Chicago, IL.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Fragen', 'Affiliation': 'Normal Moments, Chicago, IL.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Malakooti', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Derrington', 'Affiliation': ""Division of Pediatric Critical Care Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Program in Ethics and Decision Making in Critical Illness, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002378']
1335,32644148,Evaluation of Month-24 Efficacy and Safety of Epimacular Brachytherapy for Previously Treated Neovascular Age-Related Macular Degeneration: The MERLOT Randomized Clinical Trial.,"Importance


Although anti-vascular endothelial growth factor (VEGF) treatment offers better outcomes than the natural history of neovascular age-related macular degeneration (ARMD), a less burdensome, less expensive, and more durable treatment is needed.
Objective


To assess the efficacy and safety of epimacular brachytherapy (EMB) for chronic, active, neovascular ARMD.
Design, Setting, and Participants


The Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis) Only Treatment (MERLOT) pivotal device trial was conducted at 24 National Health Service hospitals across the UK. Patients who had neovascular ARMD and received intravitreal ranibizumab were enrolled between November 10, 2009, and January 30, 2012. Eligible patients were randomized 2:1 and were stratified by lens status and angiographic lesion type to receive either EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy. Participants were followed up monthly for 24 months and then assessed at a final visit at month 36. Masking of participants and clinicians was not possible, but best-corrected visual acuity (BCVA) and imaging were analyzed by masked assessors. Analysis followed the intent-to-treat approach.
Interventions


Pars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab vs as-needed ranibizumab monotherapy.
Main Outcomes and Measures


Coprimary outcomes were the number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters. Secondary outcomes were the percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters and the mean change in angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography.
Results


Of 363 participants, 329 (90.6%) completed 24 months of follow-up (222 participants in the EMB group and 107 in the ranibizumab group). The mean (SD) age of the combined groups was 76.5 (7.4) years. The mean (SD) number of ranibizumab injections was 9.3 (6.7) in the EMB group and 8.3 (4.5) in the ranibizumab group, with a difference of 1.0 injection (95% CI, -0.3 to 2.3; P = .13). The mean (SD) BCVA change was -11.2 (15.7) ETDRS letters in the EMB group and -1.4 (10.9) ETDRS letters in the ranibizumab group, with a difference of 9.8 ETDRS letters (95% CI, -6.7 to -12.9). In the EMB group, 65.6% of participants (160 of 244) lost fewer than 15 ETDRS letters vs 86.6% (103 of 119) in the ranibizumab group, with a difference of 21% (95% CI, 12.4%-29.5%; P < .001). Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group. These abnormalities occurred outside the foveal center, and there were no unexpected safety concerns.
Conclusions and Relevance


The MERLOT trial found that despite the acceptable safety of EMB, it did not reduce the number of ranibizumab injections and was associated with worse visual acuity than anti-VEGF treatment alone; these results do not support EMB use as an adjunct treatment for chronic, active neovascular ARMD.
Trial Registration


ClinicalTrials.gov Identifier: NCT01006538.",2020,Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group.,"['24 National Health Service hospitals across the UK', 'Patients who had neovascular ARMD and received', '363 participants, 329 (90.6', 'Eligible patients', 'Previously Treated Neovascular Age-Related Macular Degeneration']","['Macular Epiretinal Brachytherapy vs Ranibizumab (Lucentis', 'EMB', 'ranibizumab', 'Epimacular Brachytherapy', 'epimacular brachytherapy (EMB', 'intravitreal ranibizumab', 'Interventions\n\n\nPars plana vitrectomy with 24 Gy EMB plus as-needed ranibizumab', 'anti-vascular endothelial growth factor (VEGF) treatment', 'EMB plus as-needed ranibizumab or as-needed ranibizumab monotherapy']","['visual acuity', 'percentage of participants losing fewer than 15 ETDRS letters and gaining 0 or more or 15 or more ETDRS letters', 'mean (SD) number of ranibizumab injections', 'angiographic total lesion size, choroidal neovascularization size, and foveal thickness on optical coherence tomography', 'Microvascular abnormalities', 'efficacy and safety', 'number of as-needed ranibizumab injections and the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA with a noninferiority margin of -5 ETDRS letters', 'mean (SD) BCVA change']","[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.358324,Microvascular abnormalities occurred in 20 of 207 eyes (9.7%) in the EMB group and 1 of 97 eyes (1.0%) in the ranibizumab group.,"[{'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Jackson', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Soare', 'Affiliation': ""Department of Ophthalmology, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Petrarca', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Neffendorf', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Petrarca', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, United Kingdom.""}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""NetwORC UK, Central Angiographic Reading Center, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': 'Reading Center, Moorfields Eye Hospital, London, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""NetwORC UK, Central Angiographic Reading Center, Queen's University of Belfast, Belfast, United Kingdom.""}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Membrey', 'Affiliation': 'Department of Ophthalmology, Maidstone Hospital, Maidstone, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Department of Ophthalmology, Bristol Eye Hospital, Bristol, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Costen', 'Affiliation': 'Department of Ophthalmology, Hull and East Yorkshire Eye Hospital, Hull, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Steel', 'Affiliation': 'Vitreoretinal Unit, Sunderland Eye Infirmary, Sunderland, United Kingdom.'}, {'ForeName': 'Riti', 'Initials': 'R', 'LastName': 'Desai', 'Affiliation': ""Department of Ophthalmology, King's College Hospital, London, United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2309']
1336,32648100,Oral versus Injectable Antibiotics in Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis: A Pilot Randomized Controlled Trial.,"OBJECTIVE


To compare oral co-amoxiclav with injectable ampicillin and amikacin for the management of asymptomatic neonates born to mothers with risk factors for infection.
METHODS


This open label, randomized controlled trial was conducted in a tertiary care teaching hospital on neonates of gestational age ≥ 34 wk with maternal risk factors for infection, who were asymptomatic at birth and accepting breastfeeds. Newborns were randomized to receive either oral co-amoxiclav or injectable ampicillin and amikacin within 1-3 h after birth. Primary outcome variable was the development of clinical signs of sepsis with or without a positive blood culture by 72 h of life. Secondary outcome variables were development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy.
RESULTS


One hundred twenty-six newborns were randomized to receive either oral co-amoxyclav (n = 63) or injectable ampicillin and amikacin (n = 63). Data were analyzed on intention to treat basis. Both groups were comparable with respect to maternal and neonatal characteristics. Incidence of clinical sepsis within three days of age was similar between the groups [2 (3.2%) vs. 1 (1.6%) in injectable and oral groups, respectively; RR (95% CI) 0.500 (0.047-5.373); p = 0.567]. No significant difference was noted for the development of sepsis by 1 wk [1 (1.6%) vs. 0 in injectable and oral groups, respectively; RR (95% CI) 0.333 (0.014-8.03100); p = 0.499]. Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
CONCLUSIONS


Oral co-amoxyclav is as effective as injectable ampicillin and amikacin for management of asymptomatic neonates born to mothers with risk factors for infection.",2020,"Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
","['Newborns', 'asymptomatic neonates born to mothers with risk factors for infection', 'Asymptomatic Neonates Born to Mothers with Risk Factors for Sepsis', 'One hundred twenty-six newborns', 'tertiary care teaching hospital on neonates of gestational age\u2009≥']","['oral co-amoxiclav or injectable ampicillin and amikacin', 'oral co-amoxiclav with injectable ampicillin and amikacin', 'oral co-amoxyclav (n\u2009=\u200963) or injectable ampicillin and amikacin', 'ampicillin and amikacin', 'Oral versus Injectable Antibiotics']","['development of clinical signs of sepsis with or without a positive blood culture by 72\xa0h of life', 'development of sepsis', 'Adverse drug reactions such as vomiting, diarrhea and skin rash', 'development of sepsis with or without a positive blood culture by 7 d of life and adverse effects of drug therapy', 'Incidence of clinical sepsis']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin and clavulanate'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0740299', 'cui_str': 'Blood culture positive for microorganism'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3164780', 'cui_str': 'Clinical sepsis'}]",126.0,0.188147,"Adverse drug reactions such as vomiting, diarrhea and skin rash were infrequent and comparable in two groups.
","[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India. ashokkumar_bhu@hotmail.com.'}, {'ForeName': 'Abhishek Kumar', 'Initials': 'AK', 'LastName': 'Dubey', 'Affiliation': 'Neonatal Unit, Department of Pediatrics, Institute of Medical Sciences, Banaras Hindu University, Varanasi, 221005, India.'}, {'ForeName': 'Sriparna', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Neonatology, All India Institute of Medical Sciences, Rishikesh, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03412-x']
1337,32644833,Effects of Extended-Release Methylphenidate Treatment on Cognitive Task Performance in Children with Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder.,"Objective:  To examine the effectiveness of four doses of psychostimulant medication, combining extended-release methylphenidate (ER-MPH) in the morning with immediate-release MPH (IR-MPH) in the afternoon, on cognitive task performance.  Method:  The sample comprised 24 children (19 boys and 5 girls) who met the  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision  (DSM-IV-TR) criteria for an autism spectrum disorder (ASD) on the  Autism Diagnostic Interview-R  and the  Autism Diagnostic Observation Schedule , and had significant symptoms of attention-deficit/hyperactivity disorder (ADHD). This sample consisted of elementary school-age, community-based children (mean chronological age = 8.8 years, SD = 1.7; mean intelligence quotient = 85; SD = 16.8). Effects of placebo and three dose levels of ER-MPH (containing 0.21, 0.35, and 0.48 mg/kg equivalent of IR-MPH) on cognitive task performance were compared using a within-subject, crossover, placebo-controlled design. Each of the four MPH dosing regimens (placebo, low-dose MPH, medium-dose MPH, and high-dose MPH) was administered for 1 week; the dosing order was counterbalanced across children.  Results:  MPH treatment was associated with significant performance gains on cognitive tasks tapping sustained attention, selective attention, and impulsivity/inhibition. Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied.  Conclusion:  The results of this study suggest that MPH formulations are associated with significant improvements on cognitive task performance in children with ASD and ADHD.",2020,"Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied.  ","['children with ASD and ADHD', '24 children (19 boys and 5 girls) who met the  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision  (DSM-IV-TR) criteria for an autism spectrum disorder (ASD) on the  Autism Diagnostic Interview-R  and the  Autism Diagnostic Observation Schedule , and had significant symptoms of attention-deficit/hyperactivity disorder (ADHD', 'Children with Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder', 'elementary school-age, community-based children (mean chronological age\u2009=\u20098.8 years, SD\u2009=\u20091.7; mean intelligence quotient\u2009=\u200985; SD\u2009=\u200916.8']","['ER-MPH', 'IR-MPH', 'MPH dosing regimens (placebo, low-dose MPH, medium-dose MPH, and high-dose MPH', 'psychostimulant medication, combining extended-release methylphenidate (ER-MPH', 'Extended-Release Methylphenidate', 'placebo']","['cognitive tasks tapping sustained attention, selective attention, and impulsivity/inhibition', 'Cognitive Task Performance', 'cognitive task performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C4517591', 'cui_str': '16.8'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.130164,"Dose/response was generally linear in the dose range studied, with no evidence of deterioration in performance at higher MPH doses in the dose range studied.  ","[{'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Pearson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Cynthia W', 'Initials': 'CW', 'LastName': 'Santos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Aman', 'Affiliation': 'Nisonger Center, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Nisonger Center, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lane', 'Affiliation': 'Department of Psychological Sciences and Department of Statistics, Rice University, Houston, Texas, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Loveland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Rosleen', 'Initials': 'R', 'LastName': 'Mansour', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Ward', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Casat', 'Affiliation': 'Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jerger', 'Affiliation': 'School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schachar', 'Affiliation': 'The Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Oscar G', 'Initials': 'OG', 'LastName': 'Bukstein', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Lynne A', 'Initials': 'LA', 'LastName': 'Cleveland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0004']
1338,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1339,32666402,Associations between commonly used patient-reported outcome tools in postpartum depression clinical practice and the Hamilton Rating Scale for Depression.,"The objective of this study is to explore the associations between the patient-reported Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17) in order to facilitate clinical decision-making. An integrated efficacy dataset of three randomized placebo-controlled trials (NCT02614547, NCT02942004, and NCT02942017) evaluating brexanolone injection, a neuroactive steroid chemically identical to allopregnanolone, in women with postpartum depression was used for this post hoc analysis. Data were pooled across treatment arms. Associations were assessed at day 30 (end-of-trial follow-up). Pearson correlation assessed the relationship between EPDS and PHQ-9 item and total scores and HAMD-17 total score. Cohen's kappa assessed agreement of EPDS remission (score < 10) and PHQ-9 remission (score < 5) with HAMD-17 remission (score ≤ 7). Ordinary least squares (OLS) regression models were used to develop equations estimating HAMD-17 total scores from EPDS and PHQ-9 scores, respectively. The total scores showed large correlations (HAMD-17/EPDS: r = 0.71, p < 0.001; HAMD-17/PHQ-9: r = 0.75, p < 0.001). Individual EPDS and PHQ-9 items significantly correlated (r= 0.35 to 0.67, all p < 0.001) with HAMD-17 total score. EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%. OLS models yielded the following equations: HAMD-17 total = 2.66 + (EPDS total × 0.87) and HAMD-17 total = 3.99 + (PHQ-9 total × 0.97). There were large and statistically significant associations between patient-reported outcomes (EPDS, PHQ-9) and clinician-reported outcomes (HAMD-17) as clinical improvements were associated with patient-reported symptom improvement. These results provide tools to help translate clinical trial data to clinical practice, thus aiding shared decision-making for this critical population.",2020,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,['women with postpartum depression'],"['brexanolone injection', 'placebo']","['PHQ-9 remission', 'Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ)-9 and clinician-reported 17-item Hamilton Depression Rating Scale (HAMD-17', 'EPDS and PHQ-9 item and total scores and HAMD-17 total score', 'EPDS remission', 'Hamilton Rating Scale for Depression', 'Individual EPDS and PHQ-9 items']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]","[{'cui': 'C4765158', 'cui_str': 'brexanolone Injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",,0.0698929,EPDS had 79% sensitivity and 67% specificity to detect HAMD-17 remission; corresponding estimates for PHQ-9 were 76% and 78%.,"[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Gerbasi', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Eldar-Lissai', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Acaster', 'Affiliation': 'Acaster Lloyd Consulting Ltd., London, UK.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Fridman', 'Affiliation': 'AMF Consulting, Los Angeles, CA, USA.'}, {'ForeName': 'Vijayveer', 'Initials': 'V', 'LastName': 'Bonthapally', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hodgkins', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kanes', 'Affiliation': 'Sage Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Meltzer-Brody', 'Affiliation': 'Department of Psychiatry, University of North Carolina School of Medicine, 101 Manning Drive, Chapel Hill, NC, 27514, USA. samantha_meltzer-brody@med.unc.edu.'}]",Archives of women's mental health,['10.1007/s00737-020-01042-y']
1340,32672806,Effectiveness of a Multimedia Educational Intervention to Improve Understanding of the Risks and Benefits of Palliative Chemotherapy in Patients With Advanced Cancer: A Randomized Clinical Trial.,"Importance


Despite requirements of informed consent, patients with advanced cancer often receive palliative chemotherapy (PC) without understanding that the likelihood of cure is remote.
Objective


To determine whether a PC educational video and booklet at treatment initiation could improve patients' understanding of its benefits and risks.
Interventions


Regimen-specific PC videos and booklets presenting information about logistics, potential benefits, life expectancy (optional), adverse effects, and alternatives. Videos featured authentic patients sharing diverse experiences. After receiving treatment recommendations, research assistants distributed materials to patients for independent review.
Design, Setting, and Participants


Multicenter randomized clinical trial of patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019.
Main Outcomes and Measures


The primary outcome was accurate expectations of chemotherapy benefits at 3 months, defined as responding ""not at all likely"" to ""What is your understanding of how likely the chemotherapy is to cure your cancer?"" (from the Cancer Care Outcomes Research and Surveillance study). Secondary outcomes included understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale).
Results


Among 186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68 [36.6%] pancreatic cancer), most patients wanted ""a lot"" of information or ""as much information as possible"" about adverse effects (149, 80.1%), likelihood of cure (148, 79.6%), and prognosis (148, 79.6%). Among the intervention arm, 59 (78%) reviewed the booklet and 30 (40%) reviewed the video within 2 weeks. The primary outcome did not differ between intervention and control arms (52.6%; 95% CI, 40.3%-65.0%; vs 55.5%; 95% CI, 45.1%-66.0%). Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance. The intervention did not increase distress, despite frank prognostic information. Other secondary outcomes were similar.
Conclusions and Relevance


Provision of an educational video and booklet did not alter patients' expectation of cure from PC. Alternative delivery strategies, such as integration with nurse teaching, could be explored in future studies.
Trial Registration


ClinicalTrials.gov Identifier: NCT02282722.",2020,"Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance.","['Patients With Advanced Cancer', 'patients with advanced cancer often receive', 'patients with advanced colorectal or pancreatic cancer starting first-line or second-line PC in 5 US cancer centers with enrollment from June 2015 to September 2017 and follow-up to December 2019', '186 patients with advanced colorectal or pancreatic cancer who were starting first-line or second-line PC (94 randomized to usual care, 92 to intervention; mean [SD] age, 59.3 [12.6] [range, 28-86] years; 107 [58%] male; 118 [63.4%] colorectal and 68']","['Palliative Chemotherapy', 'palliative chemotherapy (PC', 'PC educational video and booklet', 'Multimedia Educational Intervention']","['likelihood of cure', 'understanding of adverse effects, decisional conflict (SURE test), regret (Decisional Regret Scale), and distress (Functional Assessment of Cancer Therapy-General emotional well-being subscale', 'accurate expectations of chemotherapy benefits', 'distress, despite frank prognostic information', 'pancreatic cancer']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0398650', 'cui_str': 'Idiopathic thrombocytopenic purpura'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]",186.0,0.171388,"Accurate adverse effect understanding was more common among intervention than control patients (56.0%; 95% CI, 44.3%-67.7%; vs 40.2%; 95% CI, 29.5%-50.9%; P = .05), although this did not meet the threshold for statistical significance.","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Enzinger', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Dana-Farber/Partners CancerCare, Boston, Massachusetts.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': 'Division of Medical Oncology, University of North Carolina Lineberger Cancer Center, Chapel Hill.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Van Loon', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Matin', 'Affiliation': 'Division of Medical Oncology, Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cronin', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Cibotti', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bagley', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1921']
1341,32668990,Is Percutaneous Nephrolithotomy the Modality of Choice Versus Extracorporeal Shockwave Lithotripsy for a 20 to 30 mm Single Renal Pelvic Stone with ≤1000 Hounsfield Unit in Adults? A Prospective Randomized Comparative Study.,"Objectives:  To compare the efficacy, complications, and costs of percutaneous nephrolithotomy (PNL) and extracorporeal shock wave lithotripsy (SWL) in the treatment of a 20 to 30 mm single renal pelvic stone with a density ≤1000 HU.  Patients and Methods:  Eighty patients were prospectively randomized to receive either PNL or SWL during May 2017 to April 2019. The relevant demographic and clinical characteristics were compared.  Results:  The mean age in the PNL and SWL groups was 43.25 ± 15.16 and 44.18 ± 12.08 years, respectively. The mean stone sizes were 25.2 ± 3.9 and 24.6 ± 2.3 mm, respectively. The stone-free rate (SFR) was significantly different after the primary procedures (92.5%  vs  37.5%, respectively;  p  < 0.04), but it was comparable after 3 months (97.5%  vs  90%, respectively;  p  = 0.723), with a higher rate of auxiliary procedures after SWL ( p  = 0.017). On multivariate analysis, stone density was the only significant variable for the SFR in the SWL group ( p  = 0.004). Complications occurred in 27.5% and 22.5% of cases, respectively ( p  = 0.796). The mean costs of SWL (650.23 ± 424.74 United States Dollars [US$]) were significantly lower than those of PNL (1137.65 ± 224.43 US$;  p  < 0.0001).  Conclusions:  The SFRs for PNL and SWL were not significantly different after 3 months in the treatment of a 20 to 30 mm single renal pelvic stone with ≤1000 HU, although PNL provided a significantly higher rate after its primary procedure. SWL was significantly less costly, but it mandated a significantly higher number of auxiliary procedures than PNL.",2020,"The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure.","['a 20-30 mm single renal pelvic stone with a density ≤1000 Hounsfield unit', 'Eighty patients']","['percutaneous nephrolithotomy', 'percutaneous nephrolithotomy and shock wave lithotripsy', 'Shock wave lithotripsy', 'percutaneous nephrolithotomy or shock wave lithotripsy', 'Percutaneous Nephrolithotomy the Modality of Choice versus Shock Wave Lithotripsy']","['efficacy, complications, and costs', 'stone sizes', 'mean costs of shock wave lithotripsy', 'Complications', 'stone free rate']","[{'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0227666', 'cui_str': 'Renal pelvis structure'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0449454', 'cui_str': 'Stone size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",80.0,0.0396091,"The stone free rates for percutaneous nephrolithotomy and shock wave lithotripsy were not significantly different after three months in the treatment of a 20-30 mm single renal pelvic stone with ≤1000 Hounsfield unit, although percutaneous nephrolithotomy provided a significantly higher rate after its primary procedure.","[{'ForeName': 'Rabea Ahmed', 'Initials': 'RA', 'LastName': 'Gadelkareem', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Yaser Mahmoud', 'Initials': 'YM', 'LastName': 'Abdelsalam', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed Abdelsalam', 'Initials': 'MA', 'LastName': 'Ibraheim', 'Affiliation': 'Department of Urology, Armed Forces Medical Complex, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Reda', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Abdel-Basir', 'Initials': 'MA', 'LastName': 'Sayed', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed Shehata', 'Initials': 'AS', 'LastName': 'El-Azab', 'Affiliation': 'Assiut Urology and Nephrology Hospital, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Journal of endourology,['10.1089/end.2020.0288']
1342,32622904,"Effects of acute inspiratory loading during treadmill running on cerebral, locomotor and respiratory muscle oxygenation in women soccer players.","Respiratory limitation can be a primary mechanism for exercise cessation in female athletes. This study aimed to assess the effects of inspiratory loading (IL) on intercostal muscles (IM), vastus lateralis (VL) and cerebral (Cox) muscles oxygenation in women soccer players during high-intensity dynamic exercise. Ten female soccer players were randomized to perform in order two constant-load tests on a treadmill until the exhaustion time (Tlim) (100 % of maximal oxygen uptake- V˙O 2 ). They breathed freely or against a fixed inspiratory loading (IL) of 41 cm H 2 O (∼30 % of maximal inspiratory pressure). Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb]), total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI) were obtained by NIRs. Also, blood lactate [La - ] was obtained. IL significantly reduced Tlim (224 ± 54 vs 78 ± 20; P < 0.05) and increased [La - ], V˙O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05). IL also resulted in decrease of Δ[OxyHb] of Cox and IM during exercise compared with rest condition. In addition, decrease of Δ[OxyHb] was observed on IM during exercise when contrasted with Sham (P < 0.05). Furthermore, significant higher Δ[DeoxyHb] of IM and significant lower Δ[DeoxyHb] of Cox were observed when IL was applied during exercise in contrast with Sham (P < 0.05). These results were accompanied with significant reduction of Δ[tHb] and ΔTSI of IM and VL when IL was applied (P < 0.05). High-intensity exercise with IL decreased respiratory and peripheral muscle oxygenation with negative impact on exercise performance. However, the increase in ventilatory work did not impact cerebral oxygenation in soccer players.",2020,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","['women soccer players', 'Ten female soccer players', 'female athletes', 'women soccer players during high-intensity dynamic exercise', 'soccer players']","['acute inspiratory loading during treadmill running', 'Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb', 'High-intensity exercise with IL']","['Δ[OxyHb', 'intercostal (IM), vastus lateralis (VL) and cerebral (Cox) oxygenation', 'total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI', 'Δ[DeoxyHb', 'Δ[tHb] and ΔTSI of IM and VL', 'increased [La-], V̇O 2 , respiratory cycles and dyspnea', 'blood lactate [La', 'cerebral, locomotor and respiratory muscle oxygenation', 'exercise performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0592251,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","[{'ForeName': 'Flavia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Trimer', 'Affiliation': 'Physical Therapy Department, University of Santa Cruz Do Sul - UNISC, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bonjorno-Junior', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Claudio Ricardo', 'Initials': 'CR', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103488']
1343,32631152,Intradetrusor OnabotulinumtoxinA Injections Ameliorate Autonomic Dysreflexia while Improving Lower Urinary Tract Function and Urinary Incontinence-Related Quality of Life in Individuals with Cervical and Upper Thoracic Spinal Cord Injury.,"Pilot data of our phase IV clinical trial (pre/post study design) highlighted a beneficial effect of intradetrusor onabotulinumtoxinA (200 IU) injections to reduce autonomic dysreflexia (AD) in individuals with chronic spinal cord injury (SCI) at T6 or above. After trial completion, we assessed whether our primary expectation (i.e., decrease of AD severity in 50% of participants during urodynamics [UDS]) was met. Secondary outcome measures were reduction of spontaneous AD in daily life as well as amelioration of AD-related and urinary incontinence-related quality of life (QoL). In addition, we conducted injury-level-dependent analysis-i.e., cervical and upper thoracic-to explore group-specific treatment efficacy. Post-treatment, AD severity decreased in 82% (28/34) of all participants during UDS and in 74% (25/34) in daily life assessed with 24-h ambulatory blood pressure monitoring. In addition, urinary incontinence-related QoL was improved, cystometric capacity was increased, and maximum detrusor pressure during storage was reduced (all  p  < 0.001). Further, the treatment was well tolerated, with only minor complications (grade I [ n  = 7] and II [ n  = 7]) in accordance with the Clavien-Dindo classification recorded in 11 individuals (cervical  n  = 9, upper thoracic  n  = 2). Injury-level-dependent analysis revealed lower incidence (cervical  n  = 15/23, upper thoracic  n  = 6/11) and lesser severity (cervical  p  = 0.009; upper thoracic  p  = 0.06 [Pearson  r  = -0.6, i.e., large effect size]) of AD during UDS. Further, reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum detrusor pressure during storage (all  p  < 0.05) were found in both groups post-treatment. Intradetrusor onabotulinumtoxinA injections are an effective and safe second-line treatment option that ameliorates AD while improving lower urinary tract function and urinary incontinence-related QoL in individuals with cervical and upper thoracic SCI.",2020,"Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced.","['individuals with cervical and upper thoracic SCI', 'individuals with cervical and upper thoracic spinal cord injury', 'individuals with chronic spinal cord injury (SCI) at T6 or above']",['intradetrusor onabotulinumtoxinA (200 IU) injections'],"['AD severity', 'daily life assessed with 24-hour ambulatory blood pressure monitoring', 'autonomic dysreflexia (AD', 'cystometric capacity', 'reduced AD severity in daily life, improved urinary incontinence-related QoL, greater cystometric capacity, and lower maximum storage detrusor pressure', 'urinary tract function and urinary incontinence-related quality of life', 'urinary incontinence-related QoL', 'maximum storage detrusor pressure', 'spontaneous AD in daily life, amelioration of AD and urinary incontinence-related quality of life (QoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0228625', 'cui_str': 'Structure of upper thoracic spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0238015', 'cui_str': 'Autonomic dysreflexia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure'}, {'cui': 'C0042031', 'cui_str': 'Urinary tract function'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",,0.20053,"Additionally, urinary incontinence-related QoL was improved (all p<0.001), cystometric capacity was increased and maximum storage detrusor pressure (both p<0.001) was reduced.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Kran', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Ramirez', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rapoport', 'Affiliation': 'Department of Urologic Sciences, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mark K', 'Initials': 'MK', 'LastName': 'Nigro', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Stothers', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Urologic Sciences, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrei V', 'Initials': 'AV', 'LastName': 'Krassioukov', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of neurotrauma,['10.1089/neu.2020.7115']
1344,32634172,Optimal paramedic numbers in resuscitation of patients with out-of-hospital cardiac arrest: A randomized controlled study in a simulation setting.,"BACKGROUND


The effect of paramedic crew size in the resuscitation of patients with out-of-hospital cardiac arrest (OHCA) remains inconclusive. We hypothesised that teams with a larger crew size have better resuscitation performance including chest compression fraction (CCF), advanced life support (ALS), and teamwork performance than those with a smaller crew size.
METHODS


We conducted a randomized controlled study in a simulation setting. A total of 140 paramedics from New Taipei City were obtained by stratified sampling and were randomly allocated to 35 teams with crew sizes of 2, 3, 4, 5, and 6 (i.e. 7 teams in every paramedic crew size). A scenario involving an OHCA patient who experienced ventricular fibrillation and was attached to a cardiopulmonary resuscitation (CPR) machine was simulated. The primary outcome was the overall CCF; the secondary outcomes were the CCF in manual CPR periods, time from the first dose of epinephrine until the accomplishment of intubation, and teamwork performance. Tasks affecting the hands-off time during CPR were also analysed.
RESULTS


In all 35 teams with crew sizes of 2, 3, 4, 5, and 6, the overall CCFs were 65.1%, 64.4%, 70.7%, 72.8%, and 71.5%, respectively (P = 0.148). Teams with a crew size of 5 (58.4%, 61.8%, 68.9%, 72.4%, and 68.7%, P<0.05) had higher CCF in manual CPR periods and better team dynamics. Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics. Troubleshooting of M-CPR machine decreased the hands-off time during resuscitation (39 s), with teams comprising 2 paramedics having the longest hands-off time (63s).
CONCLUSION


Larger paramedic crew size (≧4 paramedics) did not significantly increase the overall CCF in OHCA resuscitation but showed higher CCF in manual CPR period before the setup of the CPR machine. A crew size of ≧4 paramedics can also shorten the time of ALS interventions, while teams with 5 paramedics will have the best teamwork performance. Paramedic teams with a smaller crew size should focus more on the quality of manual CPR, teamwork, and training how to troubleshoot a M-CPR machine.",2020,"Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics.","['A total of 140 paramedics from New Taipei City', 'patients with out-of-hospital cardiac arrest (OHCA', 'patients with out-of-hospital cardiac arrest']","['M-CPR machine', 'epinephrine']","['overall CCF', 'chest compression fraction (CCF), advanced life support (ALS), and teamwork performance', 'CCF in manual CPR periods, time from the first dose of epinephrine until the accomplishment of intubation, and teamwork performance', 'overall CCFs', 'overall CCF in OHCA resuscitation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0419055', 'cui_str': 'Advanced life support'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",140.0,0.0659625,"Time to the first dose of epinephrine was significantly shorter in teams with 4 paramedics, while time to completion of intubation was shortest in teams with 6 paramedics.","[{'ForeName': 'Bing Min', 'Initials': 'BM', 'LastName': 'Tsai', 'Affiliation': 'Division of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Jen-Tang', 'Initials': 'JT', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Yu-You', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Division of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Tsung-Chi', 'Initials': 'TC', 'LastName': 'Kao', 'Affiliation': 'Division Chief of Emergency Medical Service, New Taipei City Fire Department, New Taipei City, Taiwan.'}, {'ForeName': 'Lee-Wei', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Institute of Emergency and Critical Care Medicine, National Yang Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Matthew Huei-Ming', 'Initials': 'MH', 'LastName': 'Ma', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Wen-Chu', 'Affiliation': 'Department of Emergency Medicine, National Taiwan University Hospital, Taipei City, Taiwan.'}]",PloS one,['10.1371/journal.pone.0235315']
1345,32645079,Cardiopulmonary bypass and internal thoracic artery: Can roller or centrifugal pumps change vascular reactivity of the graft? The IPITA study: A randomized controlled clinical trial.,"BACKGROUND


Cardiopulmonary bypass (CPB) induces a systemic inflammatory response (SIRS) and affects the organ vascular bed. Experimentally, the lack of pulsatility alters myogenic tone of resistance arteries and increases the parietal inflammatory response. The purpose of this study was to compare the vascular reactivity of the internal thoracic arteries (ITAs) due to the inflammatory response between patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump.
METHODS


Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under CPB with a roller pump (RP group) or centrifugal pump (CFP group). ITA samples were collected before starting CPB (Time 1) and before the last coronary anastomosis during aortic cross clamping (Time 2). The primary endpoint was the endothelium-dependent relaxation of ITAs investigated using wire-myography. The secondary endpoint was the parietal inflammatory response of arteries defined by the measurements of superoxide levels, leukocytes and lymphocytes rate and gene expression of inflammatory proteins using. Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.
RESULTS


Exposure time of ITAs to the pump flow was respectively 43.3 minutes in the RP group and 45.7 minutes in the CFP group. Acetylcholine-dependent relaxation was conserved in the two groups whatever the time. Gene expression of C3 and C4a in the artery wall decreased from Time 1 to Time 2. No oxidative stress was observed in the graft. There was no difference between the groups concerning the leukocytes and lymphocytes rate. SC5b-9 and elastase increased between Time 1 and Time 2.
CONCLUSION


Endothelium-dependent relaxation of the internal thoracic arteries was preserved during CPB whatever the type of pump used. The inflammatory response observed in the blood was not found in the graft wall within this time frame.
TRIAL REGISTRATION


Name of trial study protocol: IPITA Registration number (ClinicalTrials.gov): NCT04168853.",2020,"Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.
","['patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump', 'Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under']","['internal thoracic arteries (ITAs', 'Cardiopulmonary bypass (CPB', 'Cardiopulmonary bypass and internal thoracic artery', 'CPB with a roller pump (RP group) or centrifugal pump (CFP group', 'Acetylcholine']","['leukocytes and lymphocytes rate', 'parietal inflammatory response of arteries defined by the measurements of superoxide levels, leukocytes and lymphocytes rate and gene expression of inflammatory proteins using', 'oxidative stress', 'parietal inflammatory response', 'vascular reactivity', 'Gene expression of C3 and C4a', 'SC5b-9 and elastase', 'Exposure time of ITAs to the pump flow', 'endothelium-dependent relaxation of ITAs investigated using wire-myography', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0444755', 'cui_str': 'Centrifugal pump'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}]","[{'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444755', 'cui_str': 'Centrifugal pump'}, {'cui': 'C0055162', 'cui_str': 'CFP protocol'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0038836', 'cui_str': 'Superoxide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0523345', 'cui_str': 'Complement C4a measurement'}, {'cui': 'C0074124', 'cui_str': 'SC5b-9 protein complex'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0242599', 'cui_str': 'Neutrophil Activation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}, {'cui': 'C0027081', 'cui_str': 'Myography'}]",80.0,0.0607982,"Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.
","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fouquet', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dang Van', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Baudry', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Meisnerowski', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'MITOVASC Institute CNRS UMR 6214, INSERM U1083, University of Angers, Angers, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Pinaud', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Binuani', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Chrétien', 'Affiliation': 'Clinical Research Department, University Hospital, Angers, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Henrion', 'Affiliation': 'MITOVASC Institute CNRS UMR 6214, INSERM U1083, University of Angers, Angers, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Baufreton', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, University Hospital, Angers, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Loufrani', 'Affiliation': 'MITOVASC Institute CNRS UMR 6214, INSERM U1083, University of Angers, Angers, France.'}]",PloS one,['10.1371/journal.pone.0235604']
1346,32649708,Feasibility and acceptability of a milk and resistance exercise intervention to improve muscle function in community-dwelling older adults (MIlkMAN): Pilot study.,"BACKGROUND


Dietary protein supplementation combined with resistance exercise (RE) may counteract declines in muscle strength, mass, and function (sarcopenia), but the role of whole foods rich in protein, such as milk, is less well understood. In the MIlkMAN study, we aimed to examine the feasibility and acceptability of milk+RE as an intervention for muscle function in community-dwelling older adults, and provide exploratory pilot data for future substantive research in population at risk of sarcopenia.
METHODS


In a parallel groups design, 30 older adults (71.7±3.6 years; 12 women) were randomised into three groups: WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE. RE was performed twice-weekly over 6 weeks in a community gym, followed by the consumption of 500 ml of milk (~20 g protein) or carbohydrate drink immediately after exercise and a further 500 ml at home within the following 4-5 hours. The feasibility and acceptability of the study was determined by calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events.
RESULTS


The response rate was 49% (out of 400 invitations sent), and the recruitment rate was 73.2% (30 participants recruited out of 41 screened for eligibility). Twenty-nine participants completed the intervention-an attendance rate of 97.1%; 89.7% rated their experience as 'excellent'/very good'. Compliance with taking the drinks was 97.1% (WM), 98.3% (SM), and 95.0% (C); 93.1% rated their drink intake as 'easy'/'very easy' with no adverse effects. Collection of exploratory pilot data to inform future trials was successful. Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
CONCLUSIONS


This community-based milk+RE intervention was feasible and acceptable to older adults. The study successfully collected pilot data for future substantive research.",2020,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","['30 older adults (71.7±3.6 years; 12 women', 'older adults', 'community-dwelling older adults', '20', 'community-dwelling older adults (MIlkMAN']","['milk and resistance exercise intervention', 'milk+RE', 'carbohydrate drink', 'WM (whole milk 3.6% fat)+RE, SM (skimmed milk 0.3% fat)+RE, and C (isocaloric carbohydrate drink)+RE', 'Dietary protein supplementation combined with resistance exercise (RE', 'milk+RE intervention']","['attendance rate', 'muscle function', 'Mean change in grip strength, 5-chair rises, and gait speed', ""calculating recruitment and attendance rates, compliance with the intervention, rating participants' experiences, and recording adverse health events"", 'response rate', 'Feasibility and acceptability']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0402554', 'cui_str': 'Milkman'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0452717', 'cui_str': 'Whole milk'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0398701,"Mean change in grip strength, 5-chair rises, and gait speed were 0.9±3.4 kg, 1.8±2.2 s, 0.1±0.1 m/s, respectively with no differences between the groups.
","[{'ForeName': 'Antoneta', 'Initials': 'A', 'LastName': 'Granic', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hurst', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Lorelle', 'Initials': 'L', 'LastName': 'Dismore', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Research and Development, North Tyneside General Hospital, North Shields, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Stevenson', 'Affiliation': 'Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Avan A', 'Initials': 'AA', 'LastName': 'Sayer', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Aspray', 'Affiliation': 'AGE Research Group, Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235952']
1347,32649717,Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial.,"OBJECTIVE


Intranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting.
METHODS


We randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (≥7, scale: 0 ""none"" to 10 ""worst pain""). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group).
RESULTS


At T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
CONCLUSIONS


Two of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02459964.",2020,"Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
","['cancer patients with severe pain in an emergency department (ED) setting', 'patients with cancer in the emergency department setting', '82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40']","['INF relative to IVH', 'Intranasal fentanyl spray versus intravenous opioids', 'Intranasal fentanyl (INF', 'hydromorphone (IVH']","['maximum pain at T0 and that T0 pain', 'T0 pain ratings', 'mean pain decrease', 'mean pain change', 'mean log-transformed pain ratings', '2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group', 'severe pain', 'pain change']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",82.0,0.173866,"Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).
","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Banala', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Osama K', 'Initials': 'OK', 'LastName': 'Khattab', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Valda D', 'Initials': 'VD', 'LastName': 'Page', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Carla L', 'Initials': 'CL', 'LastName': 'Warneke', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Knox H', 'Initials': 'KH', 'LastName': 'Todd', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}, {'ForeName': 'Sai-Ching Jim', 'Initials': 'SJ', 'LastName': 'Yeung', 'Affiliation': 'Department of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.'}]",PloS one,['10.1371/journal.pone.0235461']
1348,32649733,An exploratory Study of EEG Alpha Oscillation and Pupil Dilation in Hearing-Aid Users During Effortful listening to Continuous Speech.,"Individuals with hearing loss allocate cognitive resources to comprehend noisy speech in everyday life scenarios. Such a scenario could be when they are exposed to ongoing speech and need to sustain their attention for a rather long period of time, which requires listening effort. Two well-established physiological methods that have been found to be sensitive to identify changes in listening effort are pupillometry and electroencephalography (EEG). However, these measurements have been used mainly for momentary, evoked or episodic effort. The aim of this study was to investigate how sustained effort manifests in pupillometry and EEG, using continuous speech with varying signal-to-noise ratio (SNR). Eight hearing-aid users participated in this exploratory study and performed a continuous speech-in-noise task. The speech material consisted of 30-second continuous streams that were presented from loudspeakers to the right and left side of the listener (±30° azimuth) in the presence of 4-talker background noise (+180° azimuth). The participants were instructed to attend either to the right or left speaker and ignore the other in a randomized order with two different SNR conditions: 0 dB and -5 dB (the difference between the target and the competing talker). The effects of SNR on listening effort were explored objectively using pupillometry and EEG. The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition. This study demonstrates that both measures are sensitive to changes in SNR during continuous speech.",2020,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"['Eight hearing-aid users participated', 'Hearing-Aid Users', 'Individuals with hearing loss allocate cognitive resources']","['EEG Alpha Oscillation and Pupil Dilation', 'continuous speech-in-noise task', 'SNR', 'continuous speech with varying signal-to-noise ratio (SNR']",['mean pupil dilation and decreased EEG alpha power'],"[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0919808', 'cui_str': 'Hearing aid user'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026961', 'cui_str': 'Dilated pupil'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0156161,The results showed larger mean pupil dilation and decreased EEG alpha power in the parietal lobe during the more effortful condition.,"[{'ForeName': 'Tirdad', 'Initials': 'T', 'LastName': 'Seifi Ala', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Graversen', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Wendt', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Alickovic', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Whitmer', 'Affiliation': 'Hearing Sciences-Scottish Section, Division of Clinical Neuroscience, University of Nottingham, Glasgow, Scotland, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lunner', 'Affiliation': 'Eriksholm Research Centre, Oticon A/S, Snekkersten, Denmark.'}]",PloS one,['10.1371/journal.pone.0235782']
1349,32657437,Niacinamide mitigates SASP-related inflammation induced by environmental stressors in human epidermal keratinocytes and skin.,"OBJECTIVE


To evaluate whether niacinamide (Nam) can mitigate production of inflammatory and senescence-related biomarkers induced by environmental stressors.
METHODS


Human epidermal keratinocytes were exposed to UVB, urban dust, diesel exhaust and cigarette smoke extract and treated with Nam or vehicle control. Full thickness 3-D skin organotypic models were exposed to a combination of UVB and PM 2.5  and treated with Nam or vehicle control. Quantitation of the SASP-related inflammatory mediators PGE 2  , IL-6 and IL-8 was performed on cultured media. UVB-exposed keratinocytes treated with and without Nam were immunostained for the senescence biomarker Lamin B1 (LmnB1). Transcriptomics profiling of cigarette smoke extract effects on keratinocytes was performed. A double-blind, placebo-controlled clinical was conducted on 40 female panellists that were pretreated on back sites for two weeks with 5% Nam or vehicle and then exposed to 1.5 minimal erythemal dose (MED) solar-simulated radiation (SSR). Treated sites were compared with non-treated exposed sites for erythema and the skin surface IL-1αRA/IL-1α inflammatory biomarkers.
RESULTS


Ultraviolet B induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes. Urban dust and diesel exhaust only stimulated synthesis of IL-8 whereas cigarette smoke extract only stimulated levels of PGE 2  . In all exposures, treatment with Nam significantly mitigated synthesis of the inflammatory mediators and restored levels of UVB-reduced LmnB1. In the 3D skin equivalent model, Nam reduced IL-8 levels stimulated by a combination of topical PM 2.5  and UV exposure. In a UV challenge clinical, pretreatment with 5% Nam reduced erythema and skin surface IL-1αRA/IL-1α inflammatory biomarkers that were induced by SSR.
CONCLUSION


Since it is known that Nam has anti-inflammatory properties, we tested whether Nam can inhibit environmental stress-induced inflammation and senescence-associated secretory phenotype (SASP) biomarkers. We show Nam can reduce PGE 2  , IL-6 and IL-8 levels induced by environmental stressors. Additionally, in vivo pretreatment with Nam can reduce UV-induced erythema and skin surface inflammatory biomarkers. These findings add to the body of evidence that Nam can mitigate the skin's inflammatory response elicited by environmental stressors. This supports Nam can potentially inhibit senescence and premature ageing and thereby maintain skin's functionality and appearance.",2020,"RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes.","['40 female panelists that were pretreated on back sites for two weeks with', 'Human epidermal keratinocytes were exposed to UVB, urban dust, diesel exhaust, and']","['niacinamide (Nam', 'cigarette smoke extract and treated with Nam or vehicle control', 'UVB and PM 2.5  and treated with Nam or vehicle control', '5% Nam or vehicle and then exposed to 1.5 minimal erythemal dose (MED) solar simulated radiation (SSR', 'placebo']","['synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels', 'PGE 2  , IL-6, and IL-8 levels', 'mitigated synthesis of the inflammatory mediators and restored levels of UVB-reduced LmnB1', 'IL-8 levels', 'erythema and skin surface IL-1αRA/IL-1α inflammatory biomarkers', 'UV-induced erythema and skin surface inflammatory biomarkers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",40.0,0.0491362,"RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Bierman', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Laughlin', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Tamura', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Ben C', 'Initials': 'BC', 'LastName': 'Hulette', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mack', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Sherrill', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Christina Y R', 'Initials': 'CYR', 'LastName': 'Tan', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, #06-06 Immunos, Singapore, 138648, Singapore.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Morenc', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, #06-06 Immunos, Singapore, 138648, Singapore.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bellanger', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, #06-06 Immunos, Singapore, 138648, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Oblong', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}]",International journal of cosmetic science,['10.1111/ics.12651']
1350,32654917,Left Ventricular Pressure-Strain Loop-Based Quantitative Examination of the Global and Regional Myocardial Work of Patients with Dilated Cardiomyopathy.,"The aim of our prospective pilot study was to explore the distribution characteristics of myocardial work (MW) of patients with dilated cardiomyopathy (DCM) and their clinical value in evaluation of therapeutic effects. Thirty patients with DCM were enrolled in the case group, and 30 healthy patients were randomly allocated to the control group. Global myocardial work (GMW) and regional myocardial work (RMW) of the control and case groups before and after therapy were evaluated by using left ventricular pressure-strain loops and then compared. We found significant differences in GMW and RMW between the control and case groups (p < 0.05). Compared with before therapy, the global work index and 6-min walking distance increased, but LV ejection fraction and global longitudinal strain did not significantly change after therapy. GMW was significantly correlated with LV ejection fraction and global longitudinal strain (p < 0.01). Bland-Altman plot analysis revealed that GMW values were consistent between and within the groups. The results suggest that LV MW values were diffusely impaired in patients with DCM and that the global work index may be used as an indicator in evaluation of therapeutic effects.",2020,We found significant differences in GMW and RMW between the control and case groups (p < 0.05).,"['Thirty patients with DCM were enrolled in the case group, and 30 healthy patients', 'Patients with Dilated Cardiomyopathy', 'patients with dilated cardiomyopathy (DCM', 'patients with DCM']",[],"['GMW', 'LV ejection fraction and global longitudinal strain', 'global work index and 6-min walking distance increased, but LV ejection fraction and global longitudinal strain', 'GMW values', 'GMW and RMW', 'LV MW values', 'Global myocardial work (GMW) and regional myocardial work (RMW']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007193', 'cui_str': 'Dilated cardiomyopathy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",30.0,0.021088,We found significant differences in GMW and RMW between the control and case groups (p < 0.05).,"[{'ForeName': 'Cunying', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Danqing', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China.""}, {'ForeName': 'Lianzhong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Ultrasonography, People's Hospital of Zhengzhou University, Henan Provincial People's Hospital, Fuwai Central China Cardiovascular Hospital, Zhengzhou, China. Electronic address: lianzhong_z@126.com.""}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.06.008']
1351,32659136,Effect of Tranexamic Acid on Wound Complications and Blood Loss in Total Ankle Arthroplasty.,"BACKGROUND


Tranexamic acid (TXA) is a medication that has been shown to decrease blood loss and risk of blood transfusion in total knee and total hip arthroplasty. The purpose of this study was to evaluate the use of TXA in patients undergoing total ankle arthroplasty (TAA). We hypothesized there would be less blood loss and wound complications in patients receiving TXA.
METHODS


A retrospective review of 2 patient cohorts operated on by 2 surgeons was performed from 2010 to 2018. We compared a group of TAA patients that did not receive TXA vs a subsequent group that received TXA. Patients received 1g intravenous TXA before the tourniquet was inflated followed by another 1 g after release of the tourniquet. Intraoperative blood loss was recorded and preoperative hemoglobin and hematocrit levels were compared to postoperative levels. Intraoperative and postoperative complications were compared between the 2 groups. A total of 119 patients were included in the study, of whom 55 received TXA. No significant difference existed between the 2 groups in gender, age, body mass index, or Charlson comorbidity index.
RESULTS


There was no difference in estimated blood loss, postoperative hemoglobin/hematocrit values or preoperative to postoperative change in hemoglobin/hematocrit values. Additionally, there was no difference in wound complications or overall complication rate between the groups.
CONCLUSION


TXA has been shown to be effective in total knee and total hip arthroplasty in decreasing blood loss and transfusion risk. We did not find it to be effective in reducing intraoperative blood loss, perioperative blood loss, or wound complications in TAA.
LEVEL OF EVIDENCE


Level III, comparative study.",2020,"We did not find it to be effective in reducing intraoperative blood loss, perioperative blood loss, or wound complications in TAA.
","['A total of 119 patients were included in the study, of whom 55 received', 'Total Ankle Arthroplasty', 'patients undergoing total ankle arthroplasty (TAA', 'total knee and total hip arthroplasty', 'patients receiving TXA', '2 patient cohorts operated on by 2 surgeons was performed from 2010 to 2018']","['Tranexamic Acid', 'Tranexamic acid (TXA', 'TXA', 'intravenous TXA']","['Intraoperative and postoperative complications', 'Wound Complications and Blood Loss', 'wound complications or overall complication rate', 'preoperative hemoglobin and hematocrit levels', 'blood loss and wound complications', 'Intraoperative blood loss', 'estimated blood loss, postoperative hemoglobin/hematocrit values or preoperative to postoperative change in hemoglobin/hematocrit values', 'intraoperative blood loss, perioperative blood loss, or wound complications']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0188664', 'cui_str': 'Prosthetic total arthroplasty of ankle'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",119.0,0.0722524,"We did not find it to be effective in reducing intraoperative blood loss, perioperative blood loss, or wound complications in TAA.
","[{'ForeName': 'R Garrett', 'Initials': 'RG', 'LastName': 'Steinmetz', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Luick', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tkach', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Falcon', 'Affiliation': 'Department of Orthopedic Surgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stoner', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Hollabaugh', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Ringus', 'Affiliation': 'Orthopaedic and Sports Medicine Center of Norman, Norman, OK, USA.'}, {'ForeName': 'Amgad M', 'Initials': 'AM', 'LastName': 'Haleem', 'Affiliation': 'Department of Orthopedic Surgery, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}]",Foot & ankle international,['10.1177/1071100720934889']
1352,32659699,A web-based daily care training to improve the quality of life of mothers of children with cerebral palsy: A randomized controlled trial.,"BACKGROUND


Mothers of moderately to severely affected children with cerebral palsy (CP) have to spend a long time to take care of their children. This time-consuming responsibility affects their physical and psychosocial health. Therefore, mothers as caregivers are required to receive special training to take care of their children.
AIMS


The aim of this study was to evaluate the effectiveness of a developed web-based intervention for daily care training of children with CP on their mothers' quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain.
METHODS AND PROCEDURES


This study was a single blind randomized controlled trial. 91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years were assigned to the intervention and control groups using block randomization. Mothers in the control group received their routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention. QOL, depression, anxiety, stress, and pain were measured before and after the intervention in both groups.
OUTCOMES AND RESULTS


The results of analysis of covariance showed that after controlling the mean score of pretest of pain, the mean score of post-tests in the intervention and control groups was significantly different (P < 0.05). The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
CONCLUSIONS AND IMPLICATIONS


Designed web-based intervention affects the caregivers' QOL and pain significantly. This intervention can be used to provide daily care training for mothers of children with CP.",2020,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","['91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years', 'mothers of children with cerebral palsy', 'Mothers of moderately to severely affected children with cerebral palsy (CP', 'mothers of children with CP', 'children with CP on their mothers']","['special training', 'A web-based daily care training', 'routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention']","['quality of life', 'QOL, depression, anxiety, stress, and pain', 'mean score of pretest of pain', 'quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain', 'mean scores of physical health and total QOL scores of post-tests']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",91.0,0.0560542,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Nobakht', 'Affiliation': 'Pediatric Neurorehabilitation Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rassafiani', 'Affiliation': 'Occupational Therapy Department, Faculty of Allied Health Sciences, Kuwait University, Kuwait. Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: mrassafiani@yahoo.com.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Social Determinants of Health Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Biosatistics Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103731']
1353,32661006,A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19.,"To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively,  P  = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively,  P  = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.).",2020,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","['Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications ', 'severe COVID-19', 'Between 29 th  February to 3 rd  April 2020, 92 patients were recruited that finally 42 patients in the IFN group and 39 patients in the control group completed the study', 'patients with severe COVID-19']","['hydroxychloroquine plus lopinavir/ritonavir or atazanavir/ritonavir', 'IFN β-1a', 'IFN', 'interferon β-1a']","['reduced mortality', 'time to the clinical response', 'Efficacy and safety', 'duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization', 'time to reach clinical response', '28-day mortality', 'discharge rate', '28-day overall mortality']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",92.0,0.186626,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","[{'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran Khalilih@sina.tums.ac.ir.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kazemzadeh', 'Affiliation': 'Advanced Thoracic Research Center, Occupational Sleep Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01061-20']
1354,32666238,Effect of T-Piece Resuscitator versus Self Inflating Bag on Arterial CO 2  Levels in Preterm Neonates.,"OBJECTIVE


To compare the effect of self-inflating bag (SIB) vs. T-piece resuscitator (TPR) on PaCO 2  levels, when used for brief manual ventilation during administration of first dose of surfactant.
METHODS


Preterm neonates were randomized to receive positive pressure ventilation with either self-inflating bag or T-piece resuscitator during administration of first dose of surfactant. Arterial blood gases were obtained at baseline and 1 h after the intervention. Primary outcome was the mean change in PaCO 2  levels 1 h after the intervention.
RESULTS


Eighty neonates were enrolled (40 in each group). The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01]. The PaCO 2  change was also statistically significant in the subgroup of infants that required only non-invasive ventilation. The need for second dose of surfactant was higher in the self-inflating bag group [77% vs. 55%, RR - 1.41 (95% CI: 1.02 to 1.94); P = 0.03].
CONCLUSIONS


T-piece resuscitator results in smaller reduction in PaCO 2  levels compared to the self inflating bag, when used for brief manual ventilation during surfactant administration.",2020,"The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01].","['Preterm neonates', 'Preterm Neonates', 'Eighty neonates were enrolled (40 in each group']","['positive pressure ventilation with either self-inflating bag or T-piece resuscitator during administration of first dose of surfactant', 'self-inflating bag (SIB) vs. T-piece resuscitator (TPR', 'T-Piece Resuscitator versus Self']","['Arterial blood gases', 'mean change in PaCO 2  levels']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0182998', 'cui_str': 'Resuscitator'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}]",80.0,0.188474,"The drop in PaCO 2  at 1 h was significantly greater in the self inflating bag group as compared to the T-piece resuscitator group [8.96 ± 9.06 mmHg vs. 1.37 ± 9.06 mmHg, Mean difference = 7.58 mmHg, (95% CI: 3.78 to 11.4); P < 0.01].","[{'ForeName': 'Amrit', 'Initials': 'A', 'LastName': 'Jeevan', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India.""}, {'ForeName': 'Haribalakrishna', 'Initials': 'H', 'LastName': 'Balasubramanian', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India. doctorhbk@gmail.com.""}, {'ForeName': 'Nandkishor', 'Initials': 'N', 'LastName': 'Kabra', 'Affiliation': ""Division of Neonatology, Surya Children's Hospital, SV Road, Santacruz West, Mumbai, Maharashtra, India.""}]",Indian journal of pediatrics,['10.1007/s12098-020-03393-x']
1355,32669622,Correction: A pragmatic randomized controlled trial testing the effects of the international scientific SCI exercise guidelines on SCI chronic pain: protocol for the EPIC-SCI trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],['international scientific SCI exercise guidelines'],['SCI chronic pain'],[],"[{'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.173102,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Martin Ginis', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada. kathleen_martin.ginis@ubc.ca.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'van der Scheer', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Kendra R', 'Initials': 'KR', 'LastName': 'Todd', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Davis', 'Affiliation': 'Centre for Chronic Disease Prevention and Management, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gaudet', 'Affiliation': 'Spinal Cord Injury British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Hoekstra', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Mohammad Ehsanul', 'Initials': 'ME', 'LastName': 'Karim', 'Affiliation': 'School of Population and Public Health and Centre for Health Evaluation and Outcome Sciences, Providence Health Care, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'John L K', 'Initials': 'JLK', 'LastName': 'Kramer', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Jonathan Peter', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, UBC; Centre for Health Evaluation and Outcome Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Townson', 'Affiliation': 'Department of Medicine, Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'West', 'Affiliation': 'International Collaboration on Repair Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}]",Spinal cord,['10.1038/s41393-020-0519-2']
1356,32676976,Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.,"OBJECTIVES


To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS


A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS


An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS


Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).",2020,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","['48 participants (24 cases each arm', 'COVID-19 patients']","['control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir', 'Keguan-1-based integrative therapy']","['adverse events', 'development of ARDS', 'adverse events, time to fever resolution, ARDS development, and lung injury', 'time to fever resolution']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}]",48.0,0.271286,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","[{'ForeName': 'Jia-Bo', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhong-Xia', 'Initials': 'ZX', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Hui', 'Initials': 'JH', 'LastName': 'Dong', 'Affiliation': 'Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Feng', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Niu', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Tian-Jun', 'Initials': 'TJ', 'LastName': 'Jiang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Feng', 'Initials': 'JF', 'LastName': 'Bi', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhao-Fang', 'Initials': 'ZF', 'LastName': 'Bai', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Guo', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Si-Miao', 'Initials': 'SM', 'LastName': 'Yu', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Qiang', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zi-Teng', 'Initials': 'ZT', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhan', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Yan', 'Initials': 'PY', 'LastName': 'Li', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jin-Biao', 'Initials': 'JB', 'LastName': 'Ding', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Zhao', 'Affiliation': 'College of Life Science, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Xue-Ai', 'Initials': 'XA', 'LastName': 'Song', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jian-Yuan', 'Initials': 'JY', 'LastName': 'Tang', 'Affiliation': 'Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Dong-Chu', 'Initials': 'DC', 'LastName': 'He', 'Affiliation': 'Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan, 430070, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, Beijing, 100039, China.'}, {'ForeName': 'En-Qiang', 'Initials': 'EQ', 'LastName': 'Qin', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. qeq2004@sina.com.'}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. wrl7905@163.com.'}, {'ForeName': 'Xiao-He', 'Initials': 'XH', 'LastName': 'Xiao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3426-7']
1357,32674009,Extracorporeal shockwave therapy in the management of plantar fasciitis: A randomized controlled trial.,"BACKGROUND


This study aimed at estimating the extent to which a combination therapy of extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support) improve functional ability in the patient with plantar fasciitis when compared to usual care alone.
METHODS


Participants with plantar fasciitis were randomly allocated into two groups: ESWT (n=23), and control (n=21). All participants received home exercise program with orthotic support. In addition, ESWT group received 2000 shock waves with 0.02 mJ/mm 2  for three sessions. Functional outcomes were measured by function subscale of American orthopedic foot and ankle society (AOFAS-F) score and 12 minutes walking test including walking speed, cadence. The scores were recorded at baseline, third week and third month after the treatment. Analysis was performed using repeated measures ANOVA, and an intention to treat approach using multiple imputations.
RESULTS


Results showed that there was a significant improvement in AOFAS-F total score and walking speed over three months in both groups (p<0.001, p=0.04 respectively); improvements in AOFAS-F were particularly in activity limitation (p=0.001), walking distance (p=0.02) and walking surface (p=0.02). Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05). However, groups performed differently in cadence where there was an increase in cadence in ESWT group whereas a decline in control at the third month (p=0.07).
CONCLUSION


The results revealed that ESWT did not have an additive benefit over usual care to improve foot function and walking performance in patient with plantar fasciitis over three months post-treatment.",2020,Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05).,"['Participants with plantar fasciitis', 'plantar fasciitis', 'patient with plantar fasciitis']","['ESWT', 'extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support', 'Extracorporeal shockwave therapy', 'home exercise program with orthotic support']","['foot function and walking performance', 'walking surface', 'AOFAS-F total score and walking speed', 'AOFAS-F', 'function subscale of American orthopedic foot and ankle society (AOFAS-F) score and 12 minutes walking test including walking speed, cadence', 'cadence', 'walking distance', 'activity limitation', 'functional ability']","[{'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0430516', 'cui_str': '12-minute walk test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0431827,Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05).,"[{'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cinar', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, 8852 Saint Hubert, Montreal, QC, H2M 1Y5, Canada. Electronic address: edaccinar@gmail.com.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, 8852 Saint Hubert, Montreal, QC, H2M 1Y5, Canada. Electronic address: shikha.saxena@mail.mcgill.ca.'}, {'ForeName': 'Halil Ekrem', 'Initials': 'HE', 'LastName': 'Akkurt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Konya Training and Research Hospital, Konya Eğitim ve Araştırma Hastanesi Fiziksel Tıp ve Rehabilitasyon Kliniği, Meram, Konya, 42090, Turkey. Electronic address: ekremakkurt@yahoo.com.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uygur', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Science Cyprus International University, via Mersin 10, 99258 Lefkoşa, Turkey. Electronic address: fztuygur@yahoo.com.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101679']
1358,32674098,The Effectiveness and Safety of General and Spinal Anesthesia on Systemic Inflammatory Response in Patients with Tumor-Type Total Knee Arthroplasty.,"BACKGROUND


The anesthesia procedure in tumor-type total knee arthroplasty (TKA) may contribute to systemic inflammatory response. Therefore, we aim to investigate the effectiveness and safety of general and spinal anesthesia in patients with tumor-type TKA.
PATIENTS AND METHODS


Twenty-five patients with tumors around the knee undergoing primary unilateral TKA were randomly divided into the general anesthesia group (n = 13) and spinal anesthesia group (n = 12). Knee joint HSS scores and Western Ontario and McMaster University osteoarthritis index (WOMAC osteoarthritis) were recorded before surgery and 12 months after surgery. Visual analogue scale, C-reactive protein (CPR), tumor necrosis factor-α (TNF-α), and interleukin-8 (IL-8) concentration were measured preoperatively (T0), on the day of the operation (T1), and on the first day (T2) after the operation. Complications in the two groups were recorded.
RESULTS


The operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate were not significantly different between the general anesthesia and spinal anesthesia groups (all p > 0.05). There were no significant differences in CPR (7.6 ± 3.1, 8.1 ± 4.1, 91.3 ± 24.2 vs. 7.1 ± 2.9, 7.6 ± 3.8, 85.1 ± 19.3 pg/mL, respectively), IL-8 (12.2 ± 6.6, 13.4 ± 7.3, 19.2 ± 10.5 vs. 11.9 ± 5.7, 12.9 ± 8.6, 22.2 ± 12.4 pg/mL, respectively), and TNF-α (2.5 ± 1.7, 2.2 ± 1.9, 2.8 ± 2.1 vs. 2.4 ± 1.3, 2.7 ± 2.1, 2.9 ± 1.6 pg/mL, respectively) between the two groups at T0, T1, and T2 (all p > 0.05). There were no statistical differences in pre- and postoperative HSS knee scores (39.78 ± 11.3, 90.24 ± 15.3 vs. 42.68 ± 12.5, 91.21 ± 16.3) and WOMAC indexes (49.89 ± 7.9, 25.12 ± 6.2 vs. 51.3 ± 8.3, 23.15 ± 5.3) between the two groups (p > 0.05).
CONCLUSION


General anesthesia and spinal anesthesia in patients with tumor-type TKA had the same effectiveness and safety.",2020,"The operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate were not significantly different between the general anesthesia and spinal anesthesia groups (all p > 0.05).","['Twenty-five patients with tumors around the knee undergoing primary unilateral TKA', 'tumor-type total knee arthroplasty (TKA', 'Patients with Tumor-Type Total Knee Arthroplasty', 'patients with tumor-type TKA']","['spinal anesthesia group', 'General anesthesia and spinal anesthesia', 'general and spinal anesthesia', 'General and Spinal Anesthesia', 'general anesthesia group']","['operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate', 'WOMAC indexes', 'effectiveness and safety', 'Knee joint HSS scores and Western Ontario and McMaster University osteoarthritis index (WOMAC osteoarthritis', 'pre- and postoperative HSS knee scores', 'Complications', 'Visual analogue scale, C-reactive protein (CPR), tumor necrosis factor-α (TNF-α), and interleukin-8 (IL-8) concentration']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0428724', 'cui_str': 'Duration of tourniquet inflation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",25.0,0.0436429,"The operative time, intraoperative blood loss, postoperative drainage, tourniquet time, and complication rate were not significantly different between the general anesthesia and spinal anesthesia groups (all p > 0.05).","[{'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China.'}, {'ForeName': 'Ling Hui', 'Initials': 'LH', 'LastName': 'Pan', 'Affiliation': 'Department of Anesthesiology, Affiliated Tumor Hospital, Guangxi Medical University, Nanning, China, plinghui@hotmail.com.'}]",Oncology research and treatment,['10.1159/000507892']
1359,32679370,Early application of caffeine improves white matter development in very preterm infants.,"The aim of this study was to evaluate the effect of early prophylactic caffeine treatment on white matter development in very preterm infants using cerebral magnetic resonance imaging. A total of 194 preterm infants (≤32 weeks gestational age) were randomly assigned to the caffeine (n = 96) or placebo (n = 93) treatment group and administered with either caffeine or placebo within 72 h after birth. Cerebral magnetic resonance imaging, including diffuse tensor imaging examination, was performed at 34-36 weeks of corrected gestational age, and the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured. In total, 160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group. There were fewer instances of apnea of prematurity and shorter assisted ventilation times for infants in the caffeine group compared to the placebo group (p < 0.05). Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group. ADC values in the above white matter areas were significantly reduced in the caffeine group. However, there were no significant differences regarding the FA and ADC in the gray matter between the two groups. These results demonstrate that early administration of caffeine improves white matter micro-structural development in preterm infants, but with no significant effect on short-term complications related to prematurity.",2020,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","['very preterm infants', 'very preterm infants using cerebral magnetic resonance imaging', 'preterm infants', '194 preterm infants (≤32 weeks gestational age', '160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group']","['placebo', 'caffeine', 'caffeine or placebo', 'prophylactic caffeine']","['white matter micro-structural development', 'apnea of prematurity and shorter assisted ventilation times', 'FA values', 'fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values', 'FA and ADC', 'ADC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",194.0,0.144528,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Ruili', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Perinatal Medicine and Health, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden.'}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm 17177, Sweden. Electronic address: changlian.zhu@neuro.gu.se.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103495']
1360,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
1361,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1362,32641236,Adherence to postoperative thromboprophylactic medication among gynecologic oncology patients: A subanalysis.,"INTRODUCTION


Venous thromboembolism (VTE) is a major cause of morbidity and mortality among gynecologic cancer patients, especially in the immediate postoperative period. We sought to identify patterns related with patient non-adherence to postoperative prophylactic anticoagulation.
METHODS


Participant data (N = 400) were reviewed from a previously conducted randomized controlled trial comparing the safety and efficacy of prophylactic postoperative anticoagulation with enoxaparin versus apixaban among gynecologic oncology patients. Variables hypothesized to be related to medication adherence were pre-selected by the study authors, and adherence was defined as missing ≤2 days of medication (4 pills or 2 injections) in 28 days postoperatively. For univariate comparisons and multivariate modeling, the threshold for statistical significance was set at p < .05.
RESULTS


Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission. African American race, lower mental QOL, difficulty remembering to take medication, and 28-day ED visit or readmission were predictive of non-adherence in a multivariate model. Patients taking enoxaparin versus apixaban more frequently attributed non-adherence to pain or bruising (25.0% vs. 3.1%, P = .01).
CONCLUSION


Our findings provide new insights into factors associated with medication adherence that are particularly relevant to gynecologic oncology patients after surgery. Preoperative interventions to identify patients with these risk factors for more intensive followup of postoperative anticoagulation regimen may help increase medication adherence.",2020,"Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission.","['gynecologic cancer patients', 'Participant data (N\xa0=\xa0400', 'gynecologic oncology patients']","['enoxaparin', 'prophylactic postoperative anticoagulation with enoxaparin versus apixaban']","['mental QOL, difficulty remembering to take medication, and 28-day ED visit or readmission', 'lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission', 'adherence to pain or bruising', 'medication adherence']","[{'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0243164', 'cui_str': 'peroperative procedures'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",400.0,0.05271,"Non-adherence (N = 64) was associated with lower quality of life (QOL) score, history of anxiety disorder, decreased medication satisfaction, taking more medications at baseline, higher baseline heart rate, fewer total intraoperative procedures, not undergoing radical hysterectomy and/or lymph node dissection, not meeting 2-week postoperative milestones, and 28-day emergency department (ED) visit or readmission.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ross', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA. Electronic address: megan.ross@cuanschutz.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Glickman', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine Anschutz Medical Campus, Aurora, CO, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.06.505']
1363,32645111,The effects of ten weeks resistance training on sticking region in chest-press exercises.,"The aim of the study was to compare the effects of a 10-week chest-press resistance training on lifting regions in a trained exercise and a none-trained exercise; the barbell bench press (BBP). Thirty-five resistance trained men with 4.2 (± 2.3) years of resistance training experience were recruited. The participants were randomized to attend a resistance program, performing the chest-press, twice per week using either, Smith machine, dumbbells or laying on Swiss ball using a barbell. A six-repetitions maximum (6RM) test was conducted pre- and post-training in the trained chest-press exercise and non-trained BBP to examine lifting velocity, load displacement and the time of the pre-sticking, sticking and post-sticking regions. Additionally, the muscle activity in pectoralis major, triceps brachii, biceps brachii and deltoid anterior was examined. In the post-test, all three chest-press groups decreased lifting velocity and increased the time to reach the sticking- and post-sticking region. Independent of the type of chest-press exercise trained, no differences were observed in vertical displacement or in the muscle activity for the three lifting regions. In general, similar changes in kinematics in trained exercise and those observed in the BBP were observed for all three groups. This indicates that none of the three chest-press exercises (Swiss ball, Smith machine or dumbbells) were specific regarding the lifting regions but displaced a transferability towards the non-trained BBP. However, improved strength altered the sticking region among resistance trained men.",2020,"In the post-test, all three chest-press groups decreased lifting velocity and increased the time to reach the sticking- and post-sticking region.",['Thirty-five resistance trained men with 4.2 (± 2.3) years of resistance training experience were recruited'],"['10-week chest-press resistance training', 'Smith machine, dumbbells or laying on Swiss ball using a barbell', 'resistance training']","['lifting velocity', 'muscle activity in pectoralis major, triceps brachii, biceps brachii and deltoid anterior', 'BBP']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517758', 'cui_str': '4.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C2721273', 'cui_str': 'Balance ball exerciser'}]","[{'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}]",35.0,0.0227159,"In the post-test, all three chest-press groups decreased lifting velocity and increased the time to reach the sticking- and post-sticking region.","[{'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Rennes School of Sports, Rennes, France.'}, {'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Matthew Peter', 'Initials': 'MP', 'LastName': 'Shaw', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}, {'ForeName': 'Tom Erik Jorung', 'Initials': 'TEJ', 'LastName': 'Solstad', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Sogndal, Norway.'}]",PloS one,['10.1371/journal.pone.0235555']
1364,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
1365,32658264,Cardiovascular Safety of Abaloparatide in Postmenopausal Women With Osteoporosis: Analysis From the ACTIVE Phase 3 Trial.,"CONTEXT


Abaloparatide is a US Food and Drug Administration-approved parathyroid hormone-related peptide analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
OBJECTIVES


We assessed the cardiovascular safety profile of abaloparatide.
DESIGN


Review of heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACEs) and heart failure (HF) from: (a) ACTIVE (NCT01343004), a phase 3 trial that randomized 2463 postmenopausal women with osteoporosis to abaloparatide, teriparatide, or placebo for 18 months; (b) ACTIVExtend (NCT01657162), where participants from the abaloparatide and placebo arms received alendronate for 2 years; and (c) a pharmacology study in 55 healthy adults.
RESULTS


Abaloparatide and teriparatide transiently increased HR relative to placebo. Following first dose, mean (standard deviation [SD]) HR change from pretreatment to 1 hour posttreatment was 7.9 (8.5) beats per minute (bpm) for abaloparatide, 5.3 (7.5) for teriparatide, and 1.2 (7.1) for placebo. A similar pattern was observed over subsequent visits. In healthy volunteers, HR increase resolved within 4 hours. The corresponding change in mean supine systolic and diastolic BP 1 hour posttreatment was -2.7/-3.6 mmHg (abaloparatide), -2.0/-3.6 (teriparatide), and -1.5/-2.3 (placebo). The percentage of participants with serious cardiac AEs was similar among groups (0.9%-1.0%). In a post hoc analysis, time to first incidence of MACE + HF was longer with abaloparatide (P = 0.02 vs placebo) and teriparatide (P = 0.04 vs placebo).
CONCLUSIONS


Abaloparatide was associated with transient increases in HR and small decreases in BP in postmenopausal women with osteoporosis, with no increase in risk of serious cardiac AEs, MACE, or HF.",2020,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","['postmenopausal women at high risk of fracture', 'Postmenopausal Women with Osteoporosis', 'postmenopausal women with osteoporosis', 'healthy volunteers', 'for 18 months', '2463 postmenopausal women with osteoporosis to abaloparatide', '55 healthy adults']","['teriparatide', 'teriparatide, or placebo', 'Abaloparatide', 'alendronate', 'abaloparatide and placebo', 'placebo']","['heart rate (HR), blood pressure (BP), and cardiovascular-related adverse events (AEs), including major adverse cardiovascular events (MACE) and heart failure (HF', 'mean (SD) HR change', 'risk of serious cardiac AEs, MACE, or HF', 'mean supine systolic and diastolic BP', 'percentage of participants with serious cardiac AEs', 'Cardiovascular Safety', 'HR relative']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4042342', 'cui_str': 'abaloparatide'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",2463.0,0.501999,"Abaloparatide is an FDA-approved PTHrp analog for treatment of osteoporosis in postmenopausal women at high risk of fracture.
","[{'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Cosman', 'Affiliation': 'Department of Medicine, Columbia University, New York, New York.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Diabetic Cardiovascular Disease Center and Department of Medicine, Washington University, St Louis, Missouri.'}, {'ForeName': 'Dwight A', 'Initials': 'DA', 'LastName': 'Towler', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Mitlak', 'Affiliation': 'Clinical Development, Radius Health, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Radius Health, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Cummings', 'Affiliation': 'San Francisco Coordinating Center, Sutter Health, California; University of California, San Francisco, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa450']
1366,32658308,Fatty acid sentinels as covalently bound randomization standards for triacylglycerol (TAG) quantitative analysis.,"RATIONALE


Quantitative analysis of triacylglycerols (TAG) is impeded by a lack of standards and the huge number of potential TAG molecular species that may be present due to the combinatorial nature of glycerolipids. Randomization of acyl groups yields TAG mixtures with profiles predictable from fatty acid profiles; however, their use as calibration mixtures has been limited.
METHODS


We introduce here the principle of fatty acid isotopic sentinels that are quantitatively added prior to randomization to enable verification that randomization is complete, and that can be used as internal standards. A mixture of two isotopically labeled fatty acid methyl esters (FAME) is prepared at a ratio of 2:1 and the exact ratio is carefully measured by gas chromatography flame ionization detection (GC-FID) and randomized covalently into the acyl groups of TAG mixtures.
RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile. TAG mixture analysis reveals that the isotopic sentinels have been covalently incorporated into the TAG molecular species at <1% deviation from the expected proportions, thus verifying randomization within experimental error.
CONCLUSIONS


The sentinel principle demonstrated here as covalently incorporated internal standards verifies that randomization chemistry went to completion. It applies in general to use of combinatorial chemistry for quantitative standards.",2020,"RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile.",[],['A mixture of two isotopically labeled fatty acid methyl esters (FAME'],[],[],"[{'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0014898', 'cui_str': 'Ester'}]",[],3.0,0.0577684,"RESULTS


Reaction with catalytic amounts of NaOCH 3  yields complete randomization, such that the product FAME and TAG have the same fatty acid profile.","[{'ForeName': 'Dong Hao', 'Initials': 'DH', 'LastName': 'Wang', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'Secilia', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Tobias', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}, {'ForeName': 'J Thomas', 'Initials': 'JT', 'LastName': 'Brenna', 'Affiliation': 'Dell Pediatric Research Institute, Departments of Pediatrics, Chemistry, and Nutrition, University of Texas at Austin, 1400 Barbara Jordan Blvd, Austin, TX, USA.'}]",Rapid communications in mass spectrometry : RCM,['10.1002/rcm.8891']
1367,32653539,The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.,"Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.",2020,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","['African American adults with uncontrolled diabetes and multiple chronic health conditions', ' African American patients with uncontrolled diabetes living in medically underserved areas', 'Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability', '646 patients (n\u202f=\u202f581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC', 'African Americans individuals with uncontrolled diabetes']","['Text messaging (TM) and health coaching (HC', 'text messaging versus health coaching', 'TM and HC with enhanced usual care (EC']","['diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c', 'general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",646.0,0.105121,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Bailey', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: jeb@uthsc.edu.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Surbhi', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gatwood', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Q-consult, LLC, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Sohul A', 'Initials': 'SA', 'LastName': 'Shuvo', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ankur A', 'Initials': 'AA', 'LastName': 'Dashputre', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Brooks', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, United States of America.'}, {'ForeName': 'Bonnie L', 'Initials': 'BL', 'LastName': 'Binkley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Carrie Jo', 'Initials': 'CJ', 'LastName': 'Riordan', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Helmut O', 'Initials': 'HO', 'LastName': 'Steinberg', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Endocrinology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Cardella L', 'Initials': 'CL', 'LastName': 'Leak', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tolley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106080']
1368,32653577,Evaluation of platelet-rich plasma as a treatment for androgenetic alopecia: A randomized controlled trial.,"BACKGROUND


Platelet-rich plasma (PRP) shows promise as an androgenetic alopecia (AGA) treatment.
OBJECTIVE


To conduct a randomized placebo-controlled split-scalp study to investigate the effects of PRP on hair regrowth and thickness.
METHODS


Two 7.6-cm × 7.6-cm squares were tattooed on the scalps of 35 study participants with AGA. Areas were randomly assigned to intradermal injection with PRP or saline. Participants received 3 monthly treatment sessions with evaluation 3 months after the final treatment.
RESULTS


Hair density in the PRP-treated area was significantly increased compared with baseline at all visits. At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (P < .05). However, hair density in placebo-treated areas also increased from 151.04 ± 41.99 hairs/cm 2  to 166.72 ± 37.13 hairs/cm 2  (P < .05). There was no significant difference in hair density change between the 2 groups (P > .05). No serious adverse events were reported.
LIMITATIONS


Possible PRP diffusion due to split-scalp study design as well as microinjections causing microinjury to both sides.
CONCLUSION


PRP may have benefit in increasing hair density.",2020,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05).","['35 study participants with AGA had two 7.6-centimeter x 7.6-centimeter squares tattooed on their scalps', 'androgenetic alopecia']","['intradermal injection with PRP or saline', 'platelet-rich plasma', 'placebo']","['hair regrowth and thickness', 'hair density in PRP-treated areas', 'serious adverse events', 'Hair density', 'hair density', 'hair density change']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0475210', 'cui_str': 'cm'}, {'cui': 'C0439479', 'cui_str': 'sq. cm'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}]","[{'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",35.0,0.0990235,"At the final assessment, hair density in PRP-treated areas increased from 151 ± 39.82 hairs/cm 2  at baseline to 170.96 ± 37.14 hairs/cm 2 , a mean increase of approximately 20 hairs/cm 2  (p < 0.05).","[{'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Shapiro', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York. Electronic address: Jerry.Shapiro@nyulangone.org.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ho', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Sukhdeo', 'Affiliation': 'Pilaris Dermatology, New York, New York.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Lo Sicco', 'Affiliation': 'Ronald O. Perelman Department of Dermatology, New York University Grossman School of Medicine, New York, New York.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.07.006']
1369,32655132,Intranasal oxytocin increases heart-rate variability in men at clinical high risk for psychosis: a proof-of-concept study.,"Autonomic nervous system (ANS) dysfunction (i.e., increased sympathetic and/or decreased parasympathetic activity) has been proposed to contribute to psychosis vulnerability. Yet, we still lack directed therapeutic strategies that improve ANS regulation in psychosis or at-risk states. The oxytocin system constitutes a potential therapeutic target, given its role in ANS regulation. However, whether intranasal oxytocin ameliorates autonomic regulation during emerging psychosis is currently unknown. We pooled together two datasets, one of 30 men at clinical high risk for psychosis (CHR-P), and another of 17 healthy men, who had participated in two double-blinded, placebo-controlled, randomised, crossover MRI studies with similar protocols. All participants self-administered 40 IU of intranasal oxytocin or placebo using a nasal spray. We recorded pulse plethysmography during a period of 8 min at about 1 h post dosing and estimated heart rate (HR) and high-frequency HR variability (HF-HRV), an index of cardio-parasympathetic activity. CHR-P and healthy men did not differ at resting HR or HF-HRV under placebo. We found a significant condition × treatment effect for HF-HRV, showing that intranasal oxytocin, compared with placebo, increased HF-HRV in CHR-P but not in healthy men. The main effects of treatment and condition were not significant. In this proof-of-concept study, we show that intranasal oxytocin increases cardio-parasympathetic activity in CHR-P men, highlighting its therapeutic potential to improve autonomic regulation in this clinical group. Our findings support the need for further research on the preventive and therapeutic potential of intranasal oxytocin during emerging psychosis, where we lack effective treatments.",2020,"We found a significant condition × treatment effect for HF-HRV, showing that intranasal oxytocin, compared with placebo, increased HF-HRV in CHR-P but not in healthy men.","['men at clinical high risk for psychosis', 'CHR-P men', '30 men at clinical high risk for psychosis (CHR-P), and another of 17 healthy men, who had participated in two double-blinded', 'healthy men']","['placebo', 'intranasal oxytocin or placebo', 'intranasal oxytocin', 'Intranasal oxytocin']","['heart-rate variability', 'heart rate (HR) and high-frequency HR variability (HF-HRV), an index of cardio-parasympathetic activity', 'cardio-parasympathetic activity', 'HF-HRV']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.128575,"We found a significant condition × treatment effect for HF-HRV, showing that intranasal oxytocin, compared with placebo, increased HF-HRV in CHR-P but not in healthy men.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Micheli', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Krawczun-Rygmaczewska', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fusar-Poli', 'Affiliation': ""Early Psychosis: Interventions & Clinical detection (EPIC) lab, Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. yannis.paloyelis@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-00890-7']
1370,32659480,Effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia: A randomized controlled trial.,"PURPOSE


The present study aimed to assess the effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia.
METHODS


Thirty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: 1) voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program only (n=14). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic, electroglottographic, and acoustic assessment. The Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE). Comparison for all variables were performed between experimental group and control group.
RESULTS


Wilcoxon test showed significant improvements for experimental group for VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
CONCLUSION


Physiologic voice therapy based on semioccluded vocal tract exercises seems to be an effective tool to improve voice in subjects diagnosed with behavioral dysphonia. Apparently, most changes should be expected in variables related to physical and functional aspects compared to objective variables. Subglottic pressure and phonation threshold pressure seem to be the most change-sensitive parameters and they may reflect a reduction in phonatory effort reported by patients after voice therapy.",2020,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","['subjects diagnosed with behavioral dysphonia', 'Thirty-four participants with behavioral dysphonia', 'subjects with behavioral dysphonia']","['physiologic voice therapy program', 'phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program', 'Physiologic voice therapy']","['VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase', 'Subglottic pressure and phonation threshold pressure', 'Laryngoscopic assessment', 'Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality', 'subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",34.0,0.0112718,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile; Department of Otolaryngology, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bertucci', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: terebertucci@gmail.com.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Pacheco', 'Affiliation': 'Department of Otolaryngology, Las Condes Clinic, Av. Estoril 850, Santiago, Chile. Electronic address: cpachecob@clinicalascondes.cl.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Vicuña Mackena 44, Santiago, Chile. Electronic address: fernando.leiva.solari@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Quintana', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: quintana.b.felipe@gmail.com.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Ansaldi', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad de las Américas, Santiago, Chile. Electronic address: romina.ansaldi@gmail.com.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: cequezad@uc.cl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: daniel.uchile@gmail.com.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106023']
1371,32660604,Effects of virtual reality associated with serious games for upper limb rehabilitation inpatients with multiple sclerosis: randomized controlled trial.,"BACKGROUND


Dexterity and activities of daily living limitations on the upper limb (UL) represent one of the most common problems in patients with multiple sclerosis (MS). The aim of this study was to evaluate the effectiveness of the specially developed Serious Games that make use of the Leap Motion Controller (LMC) as main user interface for improving UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance.
METHODS


A single-blinded randomized controlled trial was conducted. The sample was randomized into two groups: an experimental group who received treatment based on serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL. Both groups received two 60 min sessions per week over a ten-week period. Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance were assessed in both groups pre-treatment, post-treatment and in a follow-up period of 1 month without receiving any treatment.
RESULTS


In the experimental group compared to the control group, significant improvements were observed in the post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity. Also, significant results were found in the follow-up in coordination, speed of movements, fine and gross for the more affected side.
CONCLUSIONS


An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.
TRIAL REGISTRATION


This randomized controlled trial has been registered at ClinicalTrials.gov Identifier: NCT04171908 , Nov 2019.",2020,"An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.
","['upper limb rehabilitation inpatients with multiple sclerosis', 'patients with multiple sclerosis (MS']","['virtual reality associated with serious games', 'serious games designed by the research team using the developed LMC based Serious Games for the UL plus conventional rehabilitation, and a control group who received the same conventional rehabilitation for the UL', 'LMC based Serious Games designed for UL rehabilitation', 'Leap Motion Controller (LMC']","['unilateral gross manual dexterity, fine manual dexterity, and coordination', 'post-treatment assessment for coordination, speed of movements, fine and gross UL dexterity', 'Grip muscle strength, coordination, speed of movements, fine and gross UL dexterity, fatigue, quality of life, satisfaction and compliance', 'follow-up in coordination, speed of movements, fine and gross for the more affected side', 'UL grip muscle strength, dexterity, fatigue, quality of life, satisfaction and compliance']","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",,0.0783139,"An experimental protocol using an LMC based Serious Games designed for UL rehabilitation showed improvements for unilateral gross manual dexterity, fine manual dexterity, and coordination in MS patients with high satisfaction and excellent compliance.
","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Cuesta-Gómez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sánchez-Herrera-Baeza', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain. patricia.sanchezherrera@urjc.es.'}, {'ForeName': 'Edwin Daniel', 'Initials': 'ED', 'LastName': 'Oña-Simbaña', 'Affiliation': 'Robotics Lab. University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Martínez-Medina', 'Affiliation': 'Asociación de Esclerosis Múltiple de Toledo (ADEMTO), Toledo, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ortiz-Comino', 'Affiliation': 'Asociación de Esclerosis Múltiple de Toledo (ADEMTO), Toledo, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Balaguer-Bernaldo-de-Quirós', 'Affiliation': 'Robotics Lab. University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jardón-Huete', 'Affiliation': 'Robotics Lab. University Carlos III of Madrid, Leganés, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Physical Medicine and Rehabilitation, Faculty of Health Sciences, Rey Juan Carlos University, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00718-x']
1372,32661106,Hyperglycemia But Not Hyperinsulinemia Is Favorable for Exercise in Type 1 Diabetes: A Pilot Study.,"OBJECTIVE


To distinguish the effects of hyperglycemia and hyperinsulinemia on exercise-induced increases in R d  and endogenous glucose production (EGP) in type 1 diabetes.
RESEARCH DESIGN AND METHODS


We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI). Glucose fluxes were measured using [6,6- 2 H 2 ] glucose before, during, and after 60 min of exercise.
RESULTS


R d  increased ( P  < 0.01) with exercise within groups, while peak R d  during exercise was lower ( P  < 0.01) in participants with type 1 diabetes than participants without diabetes during all visits. In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI. This demonstrates that hyperinsulinemia, but not hyperglycemia, blunts the compensatory exercise-induced increase in EGP in type 1 diabetes.
CONCLUSIONS


The data from this pilot study indicate that  1 ) exercise-induced compensatory increase in EGP was inhibited in participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia;  2 ) in contrast, in participants without diabetes, exercise-induced increase in EGP was inhibited only during combined hyperinsulinemia and hyperglycemia. Taken together, these results suggest that low insulin coupled with euglycemia or modest hyperglycemia appear to be the most favorable milieu for type 1 diabetes during exercise.",2020,"In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","['type 1 diabetes', 'participants with type 1 diabetes with hyperinsulinemia but not with hyperglycemia;  2 ', 'We studied six participants without diabetes and six participants with type 1 diabetes on three visits in random order for the following: euglycemia, low insulin (EuLoI); euglycemia, high insulin (EuHiI); and hyperglycemia, low insulin (HyLoI']",[],"['R d  and endogenous glucose production (EGP', 'compensatory increase in EGP', 'Hyperglycemia', 'Glucose fluxes', 'EGP']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205452', 'cui_str': '6'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0861023', 'cui_str': 'Insulin low'}]",[],"[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0903677', 'cui_str': 'TACSTD1 protein, human'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",6.0,0.031498,"In type 1 diabetes participants, EGP increased ( P  < 0.001) with exercise during EuLoI and HyLoI but not during EuHiI.","[{'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Romeres', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Rickey', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Cobelli', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dalla Man', 'Affiliation': 'Department of Information Engineering, University of Padova, Padova, Italy.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Basu', 'Affiliation': 'Division of Endocrinology, Center of Diabetes Technology, University of Virginia School of Medicine, Charlottesville, VA basu.rita@virginia.edu.'}]",Diabetes care,['10.2337/dc20-0611']
1373,32661107,"Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA).","OBJECTIVE


Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-α (HNF1A) diabetes (maturity-onset diabetes of the young type 3), but many patients do not achieve optimal glycemic control without episodes of hypoglycemia. We investigated the combination of the sulfonylurea glimepiride and the dipeptidyl peptidase 4 inhibitor linagliptin versus glimepiride monotherapy with respect to glycemic variability, glycemic control, and risk of hypoglycemia.
RESEARCH DESIGN AND METHODS


In a randomized, double-blinded, crossover trial, patients with HNF1A diabetes ( n  = 19; mean ± SD age 43 ± 14 years, BMI 24.8 ± 2.8 kg/m 2 , and glycated hemoglobin [HbA 1c ] 7.4 ± 0.2% [57.1 ± 7.3 mmol/mol]) were randomly assigned to treatment with glimepiride + linagliptin 5 mg (16 weeks), washout (4 weeks), and glimepiride + placebo (16 weeks) (or vice versa). Glimepiride was titrated targeting a fasting plasma glucose of 4.5-6.0 mmol/L without hypoglycemia. Treatments were evaluated by continuous glucose monitoring (CGM), HbA 1c , and meal test.
RESULTS


Compared with glimepiride + placebo, glimepiride + linagliptin did not significantly improve the primary end point, mean amplitude of glycemic excursions (MAGE) (mean difference -0.7 mmol/L,  P =  0.1540), but displayed significant reductions in coefficient of variation on CGM (-3.6%,  P =  0.0401), HbA 1c  (-0.5%,  P =  0.0048), and glimepiride dose (-0.7 mg/day,  P =  0.0099). β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin. Incidences of hypoglycemia were similar with both treatments.
CONCLUSIONS


Linagliptin as add-on treatment to glimepiride improved glycemic variability and control without increasing risk of hypoglycemia in patients with HNF1A diabetes.",2020,β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin.,"['patients with HNF1A diabetes ( n  = 19; mean ± SD age 43 ± 14 years, BMI 24.8 ± 2.8 kg/m 2 , and glycated hemoglobin', 'Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3', 'patients with HNF1A diabetes']","['Linagliptin', 'Placebo', 'sulfonylurea glimepiride and the dipeptidyl peptidase-4 inhibitor linagliptin versus glimepiride monotherapy', 'glimepiride + placebo, glimepiride + linagliptin', 'glimepiride', 'glimepiride + placebo', 'Glimepiride', 'glimepiride + linagliptin']","['Efficacy and Safety', 'continuous glucose monitoring (CGM), HbA 1c , and meal test', 'glycemic variability', 'Incidences of hypoglycemia', 'glycemic variability, glycemic control, and risk of hypoglycemia', 'β-cell glucose sensitivity', 'coefficient of variation on CGM', 'mean amplitude of glycemic excursions (MAGE', 'risk of hypoglycemia', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451774', 'cui_str': 'HNF1A protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",,0.166354,β-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin.,"[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Støy', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Kampmann', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Seghieri', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes care,['10.2337/dc20-0408']
1374,32661108,Effect of Afrezza on Glucose Dynamics During HCL Treatment.,"OBJECTIVE


A major obstacle in optimizing the performance of closed-loop automated insulin delivery systems has been the delay in insulin absorption and action that results from the subcutaneous (SC) route of insulin delivery leading to exaggerated postmeal hyperglycemic excursions. We aimed to investigate the effect of Afrezza inhaled insulin with ultrafast-in and -out action profile on improving postprandial blood glucose control during hybrid closed-loop (HCL) treatment in young adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS


We conducted an inpatient, three-way, randomized crossover standardized meal study to assess the efficacy and safety of Afrezza at a low (A L ) and a high (A H ) dose as compared with a standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment. Participants received two sequential meals on three study days, and premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H  and down for A L ). The primary efficacy outcome was the peak postprandial plasma glucose (PPG) level calculated by pooling data for up to 4 h after the start of each meal. Secondary outcomes included hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics.
RESULTS


The mean ± SD PPG for the rapid-acting insulin control arm and A H  was similar (185 ± 50 mg/dL vs. 195 ± 46 mg/dL, respectively;  P  = 0.45), while it was higher for meals using A L  (208 ± 54 mg/dL,  P  = 0.04). The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
CONCLUSIONS


Afrezza (A H ) premeal bolus reduced the early glycemic excursion and improved PPG during HCL compared with aspart premeal bolus. The improvement in PPG was not sustained after the end of Afrezza glucodynamic action at 120 min.",2020,"The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
",['young adults with type 1 diabetes'],"['Afrezza', 'hybrid closed-loop (HCL', 'Afrezza inhaled insulin with ultrafast-in and -out action profile', 'standard SC rapid-acting insulin (aspart) premeal bolus during Diabetes Assistant (DiAs) HCL treatment', 'premeal insulin bolus was determined based on home insulin-to-carbohydrate ratio for each meal (rounded up to the closest available Afrezza cartridge dose for A H  and down for A L ']","['early PPG level', 'PPG', 'postprandial blood glucose control', 'mean ± SD PPG', 'efficacy and safety', 'early glycemic excursion and improved PPG', 'hyperglycemic, hypoglycemic, and euglycemic venous glucose metrics', 'peak postprandial plasma glucose (PPG) level']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3834216', 'cui_str': 'Afrezza'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.101007,"The A H  achieved significantly lower early PPG level than the control arm (30 min;  P  < 0.001), and improvement in PPG waned at later time points (120 and 180 min;  P  = 0.02) coinciding with the end of Afrezza glucodynamic action.
","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Galderisi', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT alfonso.galderisi@yale.edu alfonso.galderisi@unipd.it.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, FL.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Kraemer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Weinzimer', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Department of Pediatrics, Yale School of Medicine, New Haven, CT.'}]",Diabetes care,['10.2337/dc20-0091']
1375,32445440,Remdesivir for the Treatment of Covid-19 - Preliminary Report.,"BACKGROUND


Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious.
METHODS


We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS


A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).
CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS


Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health + Hospitals- Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota, School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol & irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1376,32638392,The impact of different hair-removal behaviours on the biophysical and biochemical characteristics of female axillary skin.,"OBJECTIVE


The impact of hair removal on the biophysical and biochemical characteristics of human axillary skin is not fully understood. This study investigated the effect of different hair-removal techniques on biophysical parameters and the concentrations of key inflammatory biomarkers in the axillae of female Thai subjects. Axillary hair was removed by shaving, plucking or waxing.
METHODS


Following a 2-week washout phase without hair removal, subjects underwent visual assessment for erythema and skin dryness in one (randomized) axilla, then, hair was removed from the axilla by shaving, plucking or waxing according to each subject's established habit. Erythema and dryness were assessed again 30 min after hair removal, and buffer scrubs collected from depilated and non-depilated axillae and analysed for inflammatory cytokines; after a further 48 h, erythema, dryness and post-inflammatory hyperpigmentation (PIHP) were assessed in the depilated axilla. Biophysical assessments (skin hydration, barrier integrity, elasticity and roughness) were made in depilated and non-depilated axillae.
RESULTS


All three hair-removal techniques induced an increase in axillary erythema and skin dryness. Shaving was associated with significantly less erythema (P < 0.01), but significantly greater skin dryness (P < 0.05) versus the other techniques 30 min after hair removal. There were no between-technique differences in PIHP or biophysical parameters. Interleukins IL-1α and IL-1RA concentrations increased, and IL-8 concentration decreased following hair removal by each technique.
CONCLUSION


This is the first study to identify the principal cytokines associated with the inflammatory process triggered by axillary hair removal. A single hair-removal treatment did not appear to induce PIHP or further biophysical changes to the skin.",2020,"Interleukins IL-1α and IL-1RA concentrations increased, and IL-8 concentration decreased following hair removal by each technique.
","['female axillary skin', 'female Thai subjects']",['hair-removal techniques'],"['IL-8 concentration', 'Interleukins IL-1α and IL-1RA concentrations', 'axillary erythema and skin dryness', 'Biophysical assessments (skin hydration, barrier integrity, elasticity and roughness', 'Erythema and dryness', 'PIHP or biophysical parameters', 'erythema, dryness and post-inflammatory hyperpigmentation (PIHP', 'skin dryness', 'erythema']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0222146', 'cui_str': 'Skin structure of axilla'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]","[{'cui': 'C0018504', 'cui_str': 'Epilation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0592639,"Interleukins IL-1α and IL-1RA concentrations increased, and IL-8 concentration decreased following hair removal by each technique.
","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Evans', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bates', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Marriott', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Arnold', 'Affiliation': 'Unilever Research & Development, Port Sunlight Laboratory, Quarry Road East, Bebington, Wirral, Merseyside, CH63 3JW, UK.'}]",International journal of cosmetic science,['10.1111/ics.12648']
1377,32641374,The Association Between HbA 1c  and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4).,"OBJECTIVE


According to recent guidelines, individuals with type 1 diabetes should spend <4.0% of time per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).
RESEARCH DESIGN AND METHODS


In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA 1c  levels.
RESULTS


Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA 1c  and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA 1c  <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA 1c  7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
CONCLUSIONS


Reaching current targets for time in hypoglycemia while at the same time reaching HbA 1c  targets is challenging for patients with type 1 diabetes treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA 1c  levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.",2020,"Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
","['People With Type 1 Diabetes and Multiple Daily Insulin Injections', '161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI']","['CGM', 'continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG', 'CGM and Self-Monitoring of Blood Glucose']","['mean HbA 1c  and mean glucose levels', 'mean time spent in hypoglycemia', 'time spent in hypoglycemia and various mean glucose and HbA 1c  levels', 'Time spent in hypoglycemia', 'time with glucose levels', 'mean glucose levels', 'time spent in hypoglycemia', 'HbA 1c  and Time in Hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",161.0,0.01482,"Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
","[{'ForeName': 'Shilan', 'Initials': 'S', 'LastName': 'Seyed Ahmadi', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden shilan.seyed.ahmadi@vgregion.se.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Westman', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Pivodic', 'Affiliation': 'Statistiska Konsultgruppen, Gothenburg, Sweden.'}, {'ForeName': 'Arndís F', 'Initials': 'AF', 'LastName': 'Ólafsdóttir', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Dahlqvist', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, WA.'}, {'ForeName': 'Jarl', 'Initials': 'J', 'LastName': 'Hellman', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Type 1 Diabetes & Functional Insulins, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Polonsky', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Wijkman', 'Affiliation': 'Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Schwarcz', 'Affiliation': 'Department of Medicine, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden.'}]",Diabetes care,['10.2337/dc19-2606']
1378,32641376,Metabolic Effects of an SGLT2 Inhibitor (Dapagliflozin) During a Period of Acute Insulin Withdrawal and Development of Ketoacidosis in People With Type 1 Diabetes.,"OBJECTIVE


To determine the effect of the sodium-glucose cotransporter 2 inhibitor dapagliflozin on glucose flux, lipolysis, and ketone body concentrations during insulin withdrawal in people with type 1 diabetes.
RESEARCH DESIGN AND METHODS


A double-blind, placebo-controlled crossover study with a 4-week washout period was performed in 12 people with type 1 diabetes using insulin pump therapy. Participants received dapagliflozin or placebo in random order for 7 days. Stable isotopes were infused to measure the glucose R a , R d , and lipolysis. At isotopic steady state, insulin was withdrawn, and the study was terminated after 600 min or earlier if blood glucose reached 18 mmol/L, bicarbonate <15 mmol/L, venous pH <7.35, or capillary ketones >5.0 mmol/L.
RESULTS


At baseline, glucose R a  was significantly higher for the dapagliflozin group than the placebo group. Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB) AUC 0-180 min  were significantly higher. There was a small but significantly higher glycerol R a  (measure of lipolysis) AUC 0-180 min  with dapagliflozin. Nonesterified fatty acid concentrations were not different between treatments. When divided by BMI >27 and <27 kg/m 2 , basal glucose R a , BOHB, and glycerol R a  AUC 0-180 min  were significantly higher in the low-BMI group with dapagliflozin treatment versus the low-BMI group with placebo.
CONCLUSIONS


During insulin withdrawal, the increase in BOHB with dapagliflozin may be partially due to increased lipolysis. However, reduced renal excretion, reduced BOHB uptake by peripheral tissues, or a metabolic switch to increased ketogenesis within the liver may also play a role.",2020,"Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB)","['people with type 1 diabetes', 'People With Type 1 Diabetes', '12 people with type 1 diabetes using insulin pump therapy']","['dapagliflozin or placebo', 'dapagliflozin', 'SGLT2 Inhibitor (Dapagliflozin', 'sodium-glucose cotransporter 2 inhibitor dapagliflozin', 'placebo']","['glycerol R a  (measure of lipolysis', 'glucose flux, lipolysis, and ketone body concentrations', 'Nonesterified fatty acid concentrations', 'reduced renal excretion, reduced BOHB uptake', 'plasma glucose concentrations', 'glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB', 'basal glucose R a , BOHB, and glycerol R a  AUC 0-180 min']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1373187', 'cui_str': 'Renal Excretion'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0205112', 'cui_str': 'Basal'}]",12.0,0.111194,"Following insulin withdrawal, plasma glucose concentrations at the end point were significantly lower with dapagliflozin than placebo and glucose R d  area under the curve (AUC) 0-180 min  and β-hydroxybutyrate (BOHB)","[{'ForeName': 'Roselle A', 'Initials': 'RA', 'LastName': 'Herring', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K. roselle.herring@nhs.net.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Shojaee-Moradie', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garesse', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stevenage', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Fielding', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Agampodi', 'Initials': 'A', 'LastName': 'Mendis', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Johnsen', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'A Margot', 'Initials': 'AM', 'LastName': 'Umpleby', 'Affiliation': 'Department of Nutritional Sciences, University of Surrey, Guildford, U.K.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, Department of Health Sciences, University of Leicester, Leicester, U.K.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Russell-Jones', 'Affiliation': 'Centre for Endocrinology, Diabetes and Research, Royal Surrey County Hospital, Guildford, U.K.'}]",Diabetes care,['10.2337/dc19-2579']
1379,32641379,Impact of Acarbose on Incident Diabetes and Regression to Normoglycemia in People With Coronary Heart Disease and Impaired Glucose Tolerance: Insights From the ACE Trial.,"OBJECTIVE


We examined the impact of acarbose, an α-glucosidase inhibitor, on incident diabetes and regression to normoglycemia in 6,522 Acarbose Cardiovascular Evaluation (ACE) trial participants in China who had impaired glucose tolerance (IGT) and coronary heart disease (CHD).
RESEARCH DESIGN AND METHODS


Participants were randomly assigned to acarbose or placebo and followed with four monthly fasting plasma glucose (FPG) tests and annual oral glucose tolerance tests. Incident diabetes was defined as two successive diagnostic FPG levels ≥7 mmol/L or 2-h plasma glucose (PG) levels ≥11.1 mmol/L while taking study medication or a masked adjudicated confirmation of this diagnosis. Regression to normoglycemia was defined as FPG <6.1 mmol/L and 2-h PG <7.8 mmol/L. Intention-to-treat and on-treatment analyses were conducted using Poisson regression models, overall and for subgroups (age, sex, CHD type, HbA 1c , FPG, 2-h PG, BMI, estimated glomerular filtration rate, for IGT alone, for IGT + impaired fasting glucose, and for use of thiazides, ACE inhibitors [ACEis]/angiotensin receptor blockers [ARBs], β-blockers, calcium channel blockers, or statins).
RESULTS


Incident diabetes was less frequent with acarbose compared with placebo (3.2 and 3.8 per 100 person-years, respectively; rate ratio 0.82 [95% CI 0.71, 0.94],  P  = 0.005), with no evidence of differential effects within the predefined subgroups after accounting for multiple testing. Regression to normoglycemia occurred more frequently in those randomized to acarbose compared with placebo (16.3 and 14.1 per 100 person-years, respectively; 1.16 [1.08, 1.25],  P  < 0.0001). This effect was greater in participants not taking an ACEi or ARB (1.36 [1.21, 1.53],  P   interaction  = 0.0006). The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P  = 0.41).
CONCLUSIONS


Acarbose reduced the incidence of diabetes and promoted regression to normoglycemia in Chinese people with IGT and CHD.",2020,"The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P  = 0.41).
","['Chinese people with IGT and CHD', 'Participants', 'People With Coronary Heart Disease and Impaired Glucose Tolerance', '6,522 Acarbose Cardiovascular Evaluation trial participants in China who had impaired glucose tolerance (IGT) and coronary heart disease (CHD']","['acarbose', 'acarbose or placebo and followed with four monthly fasting plasma glucose (FPG) tests and annual oral glucose tolerance tests', 'Acarbose', 'placebo']","['likelihood of remaining in normoglycemic regression', 'diagnostic FPG levels ≥7 mmol/L or 2-h plasma glucose', 'Regression to normoglycemia', 'PG) levels']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0948955', 'cui_str': 'Cardiovascular evaluation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.176977,"The likelihood of remaining in normoglycemic regression did not differ between the acarbose and placebo groups ( P  = 0.41).
","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Department of Medicine and Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada gerstein@mcmaster.ca.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Charles A B', 'Initials': 'CAB', 'LastName': 'Scott', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Shishi', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2046']
1380,32647051,Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover.,"OBJECTIVE


To study the effect of 12 weeks of high-intensity interval training (HIIT) on glycemic control in adults with type 1 diabetes and overweight or obesity.
RESEARCH DESIGN AND METHODS


Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2  and HbA 1c  ≥7.5% were randomized to 12 weeks of either HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control. In a partial crossover design, the control group subsequently performed the 12-week HIIT intervention. The primary end point was the change in HbA 1c  from baseline to 12 weeks. Glycemic and cardiometabolic outcomes were measured at 0, 12, and 24 weeks.
RESULTS


Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 . HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08). In participants who undertook at least 50% of the prescribed HIIT intervention, the HbA 1c  reduction was significantly greater than control (HIIT -0.64 ± 0.64% [ n  = 9], control -0.14 ± 0.48% [ n  = 15],  P  = 0.04). There were no differences in insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition between groups.
CONCLUSIONS


Overall, there was no significant reduction in HbA 1c  with a 12-week HIIT intervention in adults with type 1 diabetes. However, glycemic control may improve for people who undertake HIIT with greater adherence.",2020,"HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08).","['Adults With Type 1 Diabetes and Overweight or Obesity', 'adults with type 1 diabetes', 'Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m 2  and HbA 1c  ≥7.5', 'adults with type 1 diabetes and overweight or obesity', 'Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m 2 ']","['HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control', 'high-intensity interval training (HIIT', 'High-Intensity Interval Training']","['change in HbA 1c', 'Glycemic and cardiometabolic outcomes', 'HbA 1c  reduction', 'insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition', 'HbA 1c']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517683', 'cui_str': '3.1'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",30.0,0.0504138,"HbA 1c  decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group ( P  = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%,  P  = 0.08).","[{'ForeName': 'Angela S', 'Initials': 'AS', 'LastName': 'Lee', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'McGill', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Overland', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Luo', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Callum J', 'Initials': 'CJ', 'LastName': 'Baker', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Martinez-Huenchullan', 'Affiliation': 'Central Clinical School, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jencia', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Flack', 'Affiliation': 'Diabetes Centre, Bankstown-Lidcombe Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'Department of Endocrinology, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia stephen.twigg@sydney.edu.au.'}]",Diabetes care,['10.2337/dc20-0342']
1381,32647053,Effects of Liraglutide on Cardiovascular Outcomes in Type 2 Diabetes Patients With and Without Baseline Metformin Use: Post Hoc Analyses of the LEADER Trial.,,2020,,['Type 2 Diabetes Patients With and'],['Liraglutide'],['Cardiovascular Outcomes'],"[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0347564,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Crowley', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC matthew.crowley@duke.edu.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Anastasia-Stefania', 'Initials': 'AS', 'LastName': 'Alexopoulos', 'Affiliation': 'Division of Endocrinology, Metabolism, and Nutrition, Department of Medicine, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Thomas Jon', 'Initials': 'TJ', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital and University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}]",Diabetes care,['10.2337/dc20-0437']
1382,32647054,Effects of Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists) on Esophageal and Gastric Function in Patients With Type 2 Diabetes.,"OBJECTIVE


Short-acting glucagon-like peptide 1 receptor agonists (GLP-1 RAs) decelerate gastric emptying more than long-acting GLP-1 RAs. Delayed gastric emptying is a risk factor for gastroesophageal reflux disease. We aimed to measure esophageal reflux and function as well as gastric emptying and acid secretion during treatment with short-acting (lixisenatide) and long-acting (liraglutide) GLP-1 RAs.
RESEARCH DESIGN AND METHODS


A total of 57 subjects with type 2 diabetes were randomized to a 10-week treatment with lixisenatide or liraglutide. Changes from baseline in the number of reflux episodes during 24-h pH registration in the lower esophagus, lower esophagus sphincter pressure, gastric emptying ( 13 C-sodium octanoate acid breath test), and gastric acid secretion ( 13 C-calcium carbonate breath test) were analyzed.
RESULTS


Gastric emptying half-time was delayed by 52 min (Δ 95% CI 16, 88) with lixisenatide ( P  = 0.0065) and by 25 min (3, 46) with liraglutide ( P  = 0.025). There was no difference in the number of reflux episodes (mean ± SEM 33.7 ± 4.1 vs. 40.1 ± 5.3 for lixisenatide and liraglutide, respectively,  P  = 0.17) or the extent of gastroesophageal reflux (DeMeester score) (35.1 ± 6.7 vs. 39.7 ± 7.5,  P  = 0.61), with similar results for the individual GLP-1 RAs. No significant changes from baseline in other parameters of esophageal motility and lower esophageal sphincter function were observed. Gastric acidity decreased significantly by -20.7% (-40.6, -0.8) ( P  = 0.042) with the GLP-1 RAs.
CONCLUSIONS


Lixisenatide exerted a more pronounced influence on gastric emptying after breakfast than liraglutide. Neither lixisenatide nor liraglutide had significant effects on esophageal reflux or motility. Gastric acid secretion appears to be slightly reduced by GLP-1 RAs.",2020,"RESULTS


Gastric emptying half time was delayed by 52 min (Δ [95% CI] 16, 88) with lixisenatide ( P  = 0.0065) and by 25 min (3, 46) with liraglutide ( P  = 0.025).","['57 subjects with type 2 diabetes', 'Patients With Type 2 Diabetes']","['Lixisenatide Versus Liraglutide (Short- and Long-Acting GLP-1 Receptor Agonists', 'short-acting (lixisenatide) and long-acting (liraglutide) GLP-1 RAs', 'lixisenatide or liraglutide', 'liraglutide']","['Gastric acidity', 'Delayed gastric emptying', 'gastroesophageal reflux', 'number of reflux episodes', 'Gastric emptying half time', 'Gastric acid secretion', 'esophagus sphincter pressure, gastric emptying ( 13 C-sodium octanoate acid breath test), and gastric acid secretion', 'esophageal reflux or motility', 'gastric emptying and acid secretion', 'Esophageal and Gastric Function', 'esophageal motility and lower esophageal sphincter function', 'gastric emptying']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}]","[{'cui': 'C0017120', 'cui_str': 'Gastric acidity'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232552', 'cui_str': 'Gastric acid secretion'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0142816', 'cui_str': 'Sodium caprylate'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0232538', 'cui_str': 'Gastric function'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",57.0,0.0332538,"RESULTS


Gastric emptying half time was delayed by 52 min (Δ [95% CI] 16, 88) with lixisenatide ( P  = 0.0065) and by 25 min (3, 46) with liraglutide ( P  = 0.025).","[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Quast', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Schenker', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Björn A', 'Initials': 'BA', 'LastName': 'Menge', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juris J', 'Initials': 'JJ', 'LastName': 'Meier', 'Affiliation': 'Diabetes Division, Department of Medicine I, St Josef-Hospital Bochum, Ruhr-University Bochum, Bochum, Germany juris.meier@ruhr-uni-bochum.de.'}]",Diabetes care,['10.2337/dc20-0720']
1383,32656692,Pilot Randomized Controlled Trial of an Interconception Intervention Provided by Public Health Nurses.,"OBJECTIVES


Preconception health impacts perinatal outcomes, but the difficulty in engaging reproductive-aged individuals in health promotion activities is a barrier to effective implementation of preconception interventions. Since most women have more than one pregnancy and many risk factors repeat across pregnancies, the time between pregnancies-the interconception period-may be an opportune time to improve health. Our objective was to examine the feasibility and acceptability of an interconception intervention delivered by public health nurses.
METHODS


We conducted a pilot randomized controlled trial in three small urban and rural public health units in Ontario, Canada, in 2017-2018 among women who were ≥ 18 years of age and between 2 and 12 months postpartum after a first birth. Women randomly allocated to the intervention group received a preconception risk assessment, tailored health education, and referral for clinical follow-up as needed, while those in the control group received standard care. Primary outcomes were intervention feasibility, adherence, and acceptability.
RESULTS


Of 66 eligible women, 61% agreed to participate and were randomized to the intervention (n = 16) or control (n = 24) groups. The follow-up rate was 78% at 1 month and 71% at 3 months. Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
CONCLUSIONS FOR PRACTICE


Results demonstrate the potential feasibility and acceptability of an interconception intervention delivered in a public health setting. The short- and long-term impacts of the intervention on knowledge, behavior, and health should be tested in a larger sample.",2020,"Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
","['engaging reproductive-aged individuals in health promotion activities', '66 eligible women', 'Public Health Nurses', '18\xa0years of age and between 2 and 12\xa0months postpartum after a first birth', 'three small urban and rural public health units in Ontario, Canada, in 2017-2018 among women who were\u2009≥']","['interconception intervention', 'preconception risk assessment, tailored health education, and referral for clinical follow-up as needed, while those in the control group received standard care', 'Interconception Intervention']","['feasibility and acceptability', 'knowledge, behavior, and health', 'intervention feasibility, adherence, and acceptability', 'number and length of sessions and content of recommendations']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034022', 'cui_str': 'Public health nurse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0016145', 'cui_str': 'First Birth'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",66.0,0.0888779,"Most women (83%) were satisfied with the intervention, including the number and length of sessions and content of recommendations.
","[{'ForeName': 'Saranyah', 'Initials': 'S', 'LastName': 'Ravindran', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Yoganathan', 'Affiliation': 'Interdisciplinary Centre for Health & Society, University of Toronto Scarborough, Toronto, ON, Canada.'}, {'ForeName': 'Zoe F', 'Initials': 'ZF', 'LastName': 'Cairncross', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cindy-Lee', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': ""Women's College Research Institute, Women's College Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enders', 'Affiliation': 'Ontario Public Health Association, Toronto, ON, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Graves', 'Affiliation': 'Department of Family and Community Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Mill', 'Affiliation': 'Ontario Public Health Association, Toronto, ON, Canada.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Telner', 'Affiliation': 'Department of Family and Community Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. hk.brown@utoronto.ca.'}]",Maternal and child health journal,['10.1007/s10995-020-02980-w']
1384,32660512,Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease.,"BACKGROUND


This study aimed to evaluate the effectiveness of a customized interactive video game-based (IVGB) training on balance in older adults with mild-to-moderate Parkinson's disease (PD).
METHODS


In this 12-week crossover trial, PD patients ≥65 years of age were randomly divided into Group A (a 6-week intervention phase followed by a 6-week control phase) and Group B (a 6-week control phase followed by a 6-week intervention phase). Participants received IVGB exercise training during the intervention phase and no exercise during the control phase. Functional outcomes were measured using behavioral evaluation scales and questionnaires at baseline, week 6 and week 12.
RESULTS


Twenty-four PD patients were included in this study, and were evenly divided into two groups. After Bonferroni adjustment, the changes in Modified Falls Efficacy Scale (MFES) and two subscales of Multi-Directional Reach Test were significantly different between two groups in the first 6-week period. In addition, the changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length were significantly different between two groups in the second 6-week period. Compared to controls, 6-week IVGB exercise intervention significantly improved different but overlapping functional outcomes in two groups of PD patients.
CONCLUSIONS


The customized IVGB exercise training improves balance, postural stability and confidence in preventing falls in older adults with mild-to-moderate PD. However, this IVGB exercise doesn't have a significant impact on quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov. NCT03689764 . Registered 27 September 2018, retrospectively registered.",2020,"In addition, the changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length were significantly different between two groups in the second 6-week period.","['older adults with mild-to-moderate PD', 'PD patients ≥65\u2009years of age', ""older adults with mild-to-moderate Parkinson's disease"", ""older adults with mild-to-moderate Parkinson's disease (PD"", 'Twenty-four PD patients']","['customized IVGB exercise training', 'IVGB exercise training', 'IVGB exercise', 'interactive video-game-based exercise', 'IVGB exercise intervention', 'customized interactive video game-based (IVGB) training']","['quality of life', 'behavioral evaluation scales and questionnaires', 'changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length', 'balance, postural stability and confidence', 'Modified Falls Efficacy Scale (MFES) and two subscales of Multi-Directional Reach Test']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.015981,"In addition, the changes in Berg Balance Scale, MFES, and two subscales of Maximum Step Length were significantly different between two groups in the second 6-week period.","[{'ForeName': 'Rey-Yue', 'Initials': 'RY', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Ching', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Peng', 'Affiliation': 'Taipei Neuroscience Institute, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Nung', 'Initials': 'YN', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Tai', 'Initials': 'YT', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, No. 252, Wu-Hsing St., Taipei City, 110, Taiwan.'}, {'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. chlai@tmu.edu.tw.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00725-y']
1385,32667270,Prospective Long-term Follow-up of Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation: A Randomized Clinical Trial.,"BACKGROUND


Matrix-associated autologous chondrocyte implantation (MACI) is a further development of the original autologous chondrocyte implantation periosteal flap technique (ACI-P) for the treatment of articular cartilage defects.
PURPOSE


We aimed to establish whether MACI or ACI-P provides superior long-term outcomes in terms of patient satisfaction, clinical assessment, and magnetic resonance imaging (MRI) evaluation.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


A total of 21 patients with cartilage defects at the femoral condyle were randomized to MACI (n = 11) or ACI-P (n = 10) between the years 2004 and 2006. Patients were assessed for subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0), at 1 and 2 years postoperatively (T1, T2), and at the final follow-up 8 to 11 years after surgery (T3). Onset of osteoarthritis was determined using the Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage was used to evaluate the cartilage. Adverse events were recorded to assess safety.
RESULTS


There were 16 patients (MACI, n = 9; ACI-P, n = 7) who were reassessed on average 9.6 years after surgery (76% follow-up rate). The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2. IKDC scores increased significantly at all postoperative evaluation time points in ACI-P. In MACI, IKDC scores showed a significant increase at T1 and T3 when compared with T0. In the majority of the patients (10/16; MACI, 5/9; ACI-P, 5/7) a complete defect filling was present at the final follow-up as shown by the MOCART score, and 1 patient in the ACI-P group displayed hypertrophy of the repair tissue, which represents 6% of the whole study group and 14.3% of the ACI-P group. Besides higher SF-36 vitality scores in ACI-P at T3, no significant differences were seen in clinical scores and MRI scores between the 2 methods at any time point. Revision rate was 33.3% in MACI and 28.6% in ACI-P at the last follow-up.
CONCLUSION


Our long-term results suggest that first- and third-generation ACI methods are equally effective treatments for isolated full-thickness cartilage defects of the knee. With the number of participants available, no significant difference was noted between MACI and ACI-P at any time point. Interpretation of our data has to be performed with caution due to the small sample size, which was further limited by a loss to follow-up of 24%.",2020,The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2.,"['A total of 21 patients with cartilage defects at the femoral condyle', 'n = 11) or ACI-P (n = 10) between the years 2004 and 2006']","['MACI', 'Autologous Chondrocyte Implantation With Periosteum Versus Matrix-Associated Autologous Chondrocyte Implantation', 'MACI or ACI-P', 'Matrix-associated autologous chondrocyte implantation (MACI']","['Kellgren-Lawrence score and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, and delayed gadolinium-enhanced MRI of cartilage', 'hypertrophy of the repair tissue', 'SF-36 vitality scores', 'Adverse events', 'complete defect filling', 'MACI, IKDC scores', 'Revision rate', 'clinical scores and MRI scores', 'Lysholm and Gillquist score', 'IKDC scores', 'subjective International Knee Documentation Committee (IKDC) score, Lysholm and Gillquist score, Tegner Activity Score, and 36-Item Short Form Health Survey (SF-36) preoperatively (T0']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0582800', 'cui_str': 'Condyle of femur'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0031110', 'cui_str': 'Periosteum'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C1112785', 'cui_str': 'Cartilage repair'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3850078', 'cui_str': 'Tegner Activity Level'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",21.0,0.102406,The Lysholm and Gillquist score improved in both groups after surgery and remained elevated but reached statistical significance only in ACI-P at T1 and T2.,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Barié', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Kruck', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sorbi', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Rehnitz', 'Affiliation': 'Diagnostic and Interventional Radiology, Department of Radiology, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Oberle', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zeifang', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Moradi', 'Affiliation': 'Clinic of Orthopedics and Trauma Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520928337']
1386,32652544,Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2).,"BACKGROUND


Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic.
OBJECTIVES


To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials.
METHODS


Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16-144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician's Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology).
RESULTS


In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144.
CONCLUSIONS


Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.",2020,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","['Plaque Psoriasis', 'Adults with moderate to severe PSO for ≥6 months', '186 patients']","['CZP 400 mg Q2W', 'Certolizumab Pegol', 'CZP 200 mg Q2W', 'CZP', 'Certolizumab pegol (CZP', 'CZP 200 mg Q2W. Patients not achieving Week 16 PASI 50 entered an open-label CZP 400 mg Q2W escape', 'CZP 200 mg, CZP 400 mg, placebo']","['PASI\xa075, PASI\xa090, and PGA 0/1 responder rates', 'Psoriasis Area and Severity Index (PASI) response', 'durable efficacy']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4026841', 'cui_str': 'certolizumab pegol 200 MG'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",186.0,0.321058,"At Week 48, PASI 75/90 was achieved by 72.7%/51.3% CZP 200 mg-randomised and 84.4%/62.7% CZP 400 mg-randomised patients.","[{'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology and Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Centre de Recherche Dermatologique du Québec Métropolitain, Québec, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Boehnlein', 'Affiliation': 'UCB Pharma, Monheim, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Slough, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ecoffet', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19393']
1387,32652591,Active vs. standard sun protection in patients with melanoma stage I or II: a randomized controlled feasibility trial assessing compliance with sun protection and quality of life.,,2020,"This project was designed as a randomised controlled feasibility trial to explore the feasibility of the diary method and tube count to assess patient compliance in the setting of a monocentric trial, furthermore to observe any recognisable trends regarding anxiety and QoL between the intervention and control group.","['patients with melanoma stage I or II', 'melanoma patients', 'patients with diagnosed melanoma']",['Active versus standard sun protection'],['sun protection and quality of life'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.117173,"This project was designed as a randomised controlled feasibility trial to explore the feasibility of the diary method and tube count to assess patient compliance in the setting of a monocentric trial, furthermore to observe any recognisable trends regarding anxiety and QoL between the intervention and control group.","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Goeth', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koller', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'M-V', 'Initials': 'MV', 'LastName': 'Hegemann', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Drexler', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zeman', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Huppertz', 'Affiliation': 'Centre for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berneburg', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Maisch', 'Affiliation': 'Department of Dermatology, University Hospital Regensburg, Regensburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.19395']
1388,32654255,Does physical exercise and congruent visual stimulation enhance perceptual learning?,"PURPOSE


There is currently great interest in methods that can modulate brain plasticity, both in terms of understanding the basic mechanisms, and in the remedial application to situations of sensory loss. Recent work has focussed on how different manipulations might be combined to produce new settings that reveal synergistic actions. Here we ask whether a prominent example of adult visual plasticity, called perceptual learning, is modified by other environmental factors, such as visual stimulation and physical exercise.
METHODS


We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness). We trained subjects for 5 days on a Vernier alignment task. In one group, we introduced an exercise protocol with congruent visual stimulation. The control group received the same visual stimulation, but did not exercise prior to measurement of Vernier thresholds.
RESULTS


Although the task generated large amounts of learning (~40%) and some transfer to untrained conditions in both groups, there were no specific benefits associated with either the addition of an exercise schedule or congruent visual stimulation.
CONCLUSION


In adults, short periods of physical exercise and visual stimulation do not enhance perceptual learning.",2020,"We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness).","['two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness']","['exercise protocol with congruent visual stimulation', 'physical exercise and visual stimulation', 'same visual stimulation, but did not exercise prior to measurement of Vernier thresholds', 'physical exercise and congruent visual stimulation']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",[],,0.0464675,"We quantified the magnitude, rate and transfer of perceptual learning using a peripheral Vernier alignment task, in two groups of subjects matched for a range of baseline factors (e.g. age, starting Vernier threshold, baseline fitness).","[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campana', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fongoni', 'Affiliation': 'Dipartimento di Psicologia Generale, Università di Padova, Padova, Italy.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Astle', 'Affiliation': 'Visual Neuroscience Group, School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'McGraw', 'Affiliation': 'Visual Neuroscience Group, School of Psychology, University of Nottingham, Nottingham, UK.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12712']
1389,32660869,"A Double-Blind, Randomized, Placebo-Controlled Clinical Study of Trofinetide in the Treatment of Fragile X Syndrome.","BACKGROUND


We analyze the safety and tolerability of trofinetide and provide a preliminary evaluation of its efficacy in adolescent and adult males with fragile X syndrome.
METHODS


This study was an exploratory, phase 2, multicenter, double-blind, placebo-controlled, parallel group study of the safety and tolerability of orally administered trofinetide in 72 adolescent and adult males with fragile X syndrome. Subjects were randomly assigned in a 1:1:1 ratio to 35 or 70 mg/kg twice daily trofinetide or placebo for 28 days. Safety assessments included adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications. Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
RESULTS


Both 35 and 70 mg/kg dose levels of trofinetide were well tolerated and appeared to be generally safe. Trofinetide at the 70 mg/kg dose level demonstrated efficacy compared with placebo based on prespecified criteria. On the basis of a permutation test, the probability of a false-positive outcome for the achieved prespecified success was 0.045. In the group analysis, improvement from treatment baseline was demonstrated on three fragile X syndrome-specific outcome measures.
CONCLUSIONS


Trofinetide was well tolerated in adolescent and adult males with fragile X syndrome. Despite the relatively short duration of the study, a consistent signal of efficacy at the higher dose was observed in both caregiver and clinician assessments, based on a novel analytical model incorporating evaluation of multiple key symptom areas of fragile X syndrome. This finding suggests a potential for trofinetide treatment to provide clinically meaningful improvement in core fragile X syndrome symptoms.",2020,"Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
","['72 adolescent and adult males with fragile X syndrome', 'Fragile X Syndrome', 'adolescent and adult males with fragile X syndrome']","['trofinetide or placebo', 'trofinetide', 'Placebo', 'placebo']","['safety and tolerability', 'adverse events, clinical laboratory tests, vital signs, electrocardiograms, physical examinations, and concomitant medications']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016667', 'cui_str': 'Fragile X syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",72.0,0.270683,"Efficacy measurements were categorized into four efficacy domains, which related to clinically relevant phenotypic dimensions of impairment associated with fragile X syndrome.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Berry-Kravis', 'Affiliation': 'Department of Pediatrics, Rush University Medical Center, Chicago, Illinois; Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois; Department of Biochemistry, Rush University Medical Center, Chicago, Illinois. Electronic address: Elizabeth_Berry-Kravis@rush.edu.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Horrigan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, North Carolina.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Tartaglia', 'Affiliation': ""Department of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Hagerman', 'Affiliation': 'Department of Pediatrics, University of California Davis MIND Institute, Sacramento, California.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Child and Adolescent Psychiatry, Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Hatti', 'Affiliation': 'Suburban Research Associates, Media, Pennsylvania.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'AMO Pharma Ltd., London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Yaroshinsky', 'Affiliation': 'Vital Systems, Inc., Rolling Meadows, Illinois.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Stoms', 'Affiliation': 'Vital Systems, Inc., Rolling Meadows, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Glass', 'Affiliation': 'Neuren Pharmaceuticals, Ltd., Melbourne, Victoria, Australia.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Jones', 'Affiliation': 'Neuren Pharmaceuticals, Ltd., Melbourne, Victoria, Australia.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.04.019']
1390,32687612,"Interaction of Ethanol and Oral ANS-6637, a Selective ALDH2 Inhibitor in Males: A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Cohort Study.","BACKGROUND


ANS-6637, an orally bioavailable selective and reversible aldehyde dehydrogenase-2 (ALDH2) inhibitor, is under development for drug and alcohol use disorders. During the elimination of alcohol, ALDH2 metabolizes acetaldehyde to acetate; inhibiting this enzyme can lead to aversive reactions due to the accumulation of acetaldehyde. Thus, understanding the safety and tolerability of ANS-6637 in combination with alcohol is essential.
TRIAL DESIGN AND METHODS


Forty eight healthy males participated in a randomized, double-blind, placebo-controlled, single-ascending dose cohort study of oral ANS-6637. Eligible participants were randomized to ANS-6637 (n = 36) or placebo (n = 12) in a 3:1 fashion in each of 6 dose cohorts (8 per cohort; ANS-6637 dose levels were 25, 50, 100, 200, 400, and 600 mg). Two hours after receiving study drug, participants drank up to 5 standard drinks, 1 every 30 minutes. Safety assessments, pharmacodynamic measures, and pharmacokinetic blood samples were obtained.
RESULTS


Flushing was the most common adverse event (AE) associated with ANS-6637 (24 of 36 participants) compared with placebo (3 of 12). Statistically significant, but modest, increases in heart rate (HR) occurred (+10.5 bpm after 2 drinks; +16.9 to + 20.5 bpm after 3 rd  through 5 th  drink). No participant met HR or systolic blood pressure criteria for stopping ethanol administration. There were no clinically significant QTc interval prolongations. Individuals receiving ANS-6637 reported lower ratings of liking, alcohol effects, and feeling drunk.
CONCLUSIONS


A single oral dose of ANS-6637 with up to 5 standards drinks over 2.5 hours was generally well tolerated in healthy males. The most common pharmacological response was flushing and an increase in HR, which are known effects of acetaldehyde accumulation and consistent with inhibition of ALDH2 with oral ANS-6637 in combination with alcohol. The results of this alcohol interaction study support further testing of ANS-6637 in individuals who consume alcohol heavily.",2020,"Individuals receiving ANS-6637 reported lower ratings of liking, alcohol effects, and feeling drunk.
","['Eligible participants', 'healthy males', '48 healthy males', 'Males', 'individuals with substance use disorders who may consume alcohol']","['Placebo', 'Ethanol and Oral ANS-6637, a Selective ALDH2 Inhibitor', 'ANS-6637', 'oral ANS-6637', 'placebo']","['safety and tolerability', 'ratings of liking, alcohol effects, and feeling drunk', 'heart rate (HR', 'HR or systolic blood pressure criteria', 'Safety assessments, pharmacodynamic measures and pharmacokinetic blood samples']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001985', 'cui_str': 'Aldehyde dehydrogenase (NAD^+^)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0522172', 'cui_str': 'Feeling intoxicated'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",48.0,0.210466,"Individuals receiving ANS-6637 reported lower ratings of liking, alcohol effects, and feeling drunk.
","[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'From the Department of Psychiatry, (SSO), Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Shram', 'Affiliation': 'Altreos Research Partners, (MJS, NL-C), Toronto, Ontario, Canada.'}, {'ForeName': 'Naama', 'Initials': 'N', 'LastName': 'Levy-Cooperman', 'Affiliation': 'Altreos Research Partners, (MJS, NL-C), Toronto, Ontario, Canada.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences/Vince Associates, (BV), Overland Park, Kansas, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Strumph', 'Affiliation': 'Amygdala Neurosciences, Inc, (PMS, ID, BKB), San Francisco, California, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Diamond', 'Affiliation': 'Amygdala Neurosciences, Inc, (PMS, ID, BKB), San Francisco, California, USA.'}, {'ForeName': 'Brent K', 'Initials': 'BK', 'LastName': 'Blackburn', 'Affiliation': 'Amygdala Neurosciences, Inc, (PMS, ID, BKB), San Francisco, California, USA.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14416']
1391,32663066,Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial - description of device use and physiotherapy support in the post-hospital phase.,"PURPOSE


To describe device use and physiotherapy support in the post-hospital phase of the AMOUNT rehabilitation trial.
METHODS


We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase ( n  = 144). Intervention, additional to standard rehabilitation, utilised eight digital devices (virtual reality videogames, activity monitors and handheld computer devices) to improve mobility and increase physical activity. Participants were taught to use devices during inpatient rehabilitation and were then discharged home to use the devices for the remainder of the 6-month trial. Physiotherapist-participant contact occurred every 1-2 weeks using a health coaching approach, including technology support when required. Intervention datasheets were audited, and descriptive statistics used to report device use and support required.
RESULTS


Participants (mean (SD) age 70 (18) years; 49% neurological health conditions) used an average of 2 (SD 1) devices (98% used an activity monitor). Eight percent of physiotherapy contact included technology support with 30% provided remotely. Support addressed 845 issues categorised under initial set-up and instruction (27%), education and training (31%), maintenance (23%) and trouble-shooting (19%).
CONCLUSION


Digital devices can be used for home-based rehabilitation, but ongoing technology support is essential.  Clinical Trials Registry:  ACTRN12614000936628 IMPLICATIONS FOR REHABILITATION Digital device use at home to support long-term management of health conditions is likely to become increasingly important as the need for rehabilitation increases and rehabilitation resources become more limited. Technology support for set-up and ongoing device use is a critical enabler of home-based digital interventions. Health professionals delivering home-based digital interventions require sufficient training and equipment and may need to vary the mode (e.g., home visit vs. telephone or video conference) depending on the technology support required.",2020,We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase ( n  = 144).,['Participants (mean (SD) age 70 (18) years; 49% neurological health conditions'],"['standard rehabilitation, utilised eight digital devices (virtual reality videogames, activity monitors and handheld computer devices']",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C1136005', 'cui_str': 'Computers, Handheld'}]",[],,0.0423924,We performed an evaluation of the support required for device use by participants randomised to the intervention group who received digitally-enabled rehabilitation in the post-hospital phase ( n  = 144).,"[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Maayken', 'Initials': 'M', 'LastName': 'van den Berg', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide,\xa0Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide,\xa0Australia.'}, {'ForeName': 'Sakina', 'Initials': 'S', 'LastName': 'Chagpar', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rabie', 'Affiliation': 'Liverpool Hospital, South Western Sydney Local Health District,\xa0Sydney, Australia.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McCluskey', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health,\xa0The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney,\xa0Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide,\xa0Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney/Sydney Local Health District, Sydney, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1790679']
1392,32671664,"An Investigation of the Skin Barrier Restoring Effects of a Cream and Lotion Containing Ceramides in a Multi-vesicular Emulsion in People with Dry, Eczema-Prone, Skin: The RESTORE Study Phase 1.","INTRODUCTION


The replenishment of skin lipids depleted in the dry skin state is a desirable therapeutic target to restore skin moisturization; however, there is limited evidence demonstrating the success of this approach through the use of topical emollients. The purpose of this study was to provide evidence of the benefits of a cream and equivalent lotion containing skin lipids in a multi-vesicular emulsion for the management of dry skin. The hypothesis was that the test cream and test lotion could sustain skin moisturization for longer than traditional emollients by sustainably delivering skin lipids.
METHODS


A double-blind intra-subject vehicle-controlled single open-application test on the lower legs in people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted. There were six treatment sites, three per lower leg in each participant, which were treated with the test cream, the test lotion, three reference creams commonly prescribed in the UK and no treatment as a control. After baseline measurements of skin hydration, 100 μl of the test/reference creams was applied to each of the relevant treatment sites (random site allocation). Following treatment, measurements of skin hydration and scoring of visual dryness was conducted at timed intervals (3, 6, 12 and 24 h post-product application).
RESULTS


The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site. Compared to three reference emollient creams the test cream and test lotion were the only products capable of sustaining clinically meaningful improvements in skin moisturization for 24 h.
CONCLUSION


The sustained moisturization imparted by the test products reduces the need for frequent emollient application, often requiring 3-4 applications per day for traditional emollients, and should reduce the high burden of managing dry skin conditions like atopic dermatitis.",2020,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"['People with Dry, Eczema-Prone, Skin', 'people with dry, atopic dermatitis (atopic eczema)-prone, skin was conducted', 'dry skin']","['cream and equivalent lotion containing skin lipids', 'Cream and Lotion Containing Ceramides', 'double-blind intra-subject vehicle-controlled single open-application test']","['skin hydration and scoring of visual dryness', 'skin hydration and reduced skin dryness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]",,0.0643835,The test cream and lotion both significantly increased skin hydration and reduced skin dryness for at least 24 h following a single application compared to a no treatment control site.,"[{'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Danby', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK. s.danby@sheffield.ac.uk.'}, {'ForeName': 'Paul V', 'Initials': 'PV', 'LastName': 'Andrew', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chittock', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Kay', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Cork', 'Affiliation': 'Sheffield Dermatology Research, Department of Infection, Immunity and Cardiovascular Disease, The University of Sheffield Medical School, Sheffield, UK.'}]",Dermatology and therapy,['10.1007/s13555-020-00426-3']
1393,32667956,Improved balance in middle-aged adults after 8 weeks of a modified version of Otago Exercise Program: A randomized controlled trial.,"OBJECTIVE


The objective of this randomized controlled trial was to examine dynamic balance changes (reach distance) in middle-aged adults using the Y Balance Test (YBT) following 8 weeks of home-based exercise program adapted from the Otago Exercise Program (OEP).
METHODS


Fifty-two healthy middle-aged adults with mean age of 54.4±5.4 years and body mass index of 27.7±5.7 kg/m2 were randomly assigned into either the exercise group (a modification of the Otago Exercise Program, that consisted of home-based balance and strength exercises) or the non-exercise group (continuation of usual lifestyle) by having the participants select a paper from a sealed envelope. The YBT was used to measure participants' dynamic balance in the right and left anterior (RA, LA), posteromedial (RPM, LPM), and posterolateral (RPL, LPL) directions.
RESULTS


The outcome in this trial was reach distance (cm). There was a significant group by time interaction in terms of reach distance for all directions (p<0.05, η2 ranged from 0.06 to 0.20). In the exercise group, results of the repeated measures analysis of variance (ANOVA) showed significant improvements in the reach distance in all the directions (p<0.001). In contrast, the non-exercise group had significant difference only in the left posterolateral direction (p = 0.009). Participants in the exercise group achieved significantly greater reach distance (cm) (95% confidence interval (CI)) for RA[(2.8, 0.4 to 5.2), p = 0.023]; LA[(3.2, 0.9 to 5.6), p = 0.008]; RPM[(4.0, 1.0 to 7.9), p = 0.046]; LPM[(5.8,1.3 to 10.3), p = 0.013]; RPL[(7.6, 2.6 to 12.6), p = 0.003]; and LPL[(4.2, 0.3 to 8.2), p = 0.035].
CONCLUSION


The modified version of OEP appears to be effective in improving parameters of dynamic balance in the middle-aged adult population. The improvements in YBT reach distance in the exercise group are indicative of the significance of performing balance and strength exercises regularly for this population.",2020,The modified version of OEP appears to be effective in improving parameters of dynamic balance in the middle-aged adult population.,"['middle-aged adult population', 'middle-aged adults', 'middle-aged adults using the Y Balance Test (YBT) following 8 weeks of', 'Fifty-two healthy middle-aged adults with mean age of 54.4±5.4 years and body mass index of 27.7±5.7 kg/m2']","['exercise group (a modification of the Otago Exercise Program, that consisted of home-based balance and strength exercises) or the non-exercise group (continuation of usual lifestyle) by having the participants select a paper from a sealed envelope', 'home-based exercise program adapted from the Otago Exercise Program (OEP', 'YBT']","['reach distance (cm', 'left posterolateral direction', 'YBT reach distance', 'greater reach distance (cm', 'dynamic balance changes (reach distance']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",52.0,0.0643444,The modified version of OEP appears to be effective in improving parameters of dynamic balance in the middle-aged adult population.,"[{'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Almarzouki', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Gurinder', 'Initials': 'G', 'LastName': 'Bains', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Lohman', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bradley', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Nelson', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}, {'ForeName': 'Samiah', 'Initials': 'S', 'LastName': 'Alqabbani', 'Affiliation': 'Department of Rehabilitation Sciences, School of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alonazi', 'Affiliation': 'Department of Physical Therapy, School of Applied Medical Sciences, Majmaah University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0235734']
1394,32663379,Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study.,"BACKGROUND


Pancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established.
METHODS


This trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. The primary efficacy endpoint was the composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death. The primary safety endpoint was International Society on Thrombosis and Haemostasis-defined major bleeding.
RESULTS


In total, 49/1080 (4.5%) patients enrolled had baseline VTE on screening, with higher rates (24/362 [6.6%]) in pancreatic cancer and they were not randomized. Of 841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period. The primary endpoint occurred in 13/135 (9.6%) patients in the rivaroxaban group and in 18/138 (13.0%) in the placebo group (hazard ratio [HR] = 0.70; 95% CI, 0.34-1.43; P = .328) in up-to-day-180 period and 5/135 (3.7%) patients receiving rivaroxaban and 14/138 (10.1%) receiving placebo in the intervention period (HR = 0.35; 95% CI, 0.13-0.97; P = .034). Major bleeding was similar (2 [1.5%] receiving rivaroxaban and 3 [2.3%] receiving placebo). Correlative biomarker studies demonstrated significant decline in D-dimer (weeks 8 and 16) in patients randomized to rivaroxaban compared to placebo (P < .01).
CONCLUSIONS


In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period. During the intervention period, however, rivaroxaban substantially reduced VTE without increasing major bleeding, suggesting benefit of rivaroxaban prophylaxis in this setting.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT02555878.",2020,"In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period.","['ambulatory patients with pancreatic cancer', 'cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to', 'Pancreatic cancer patients', 'pancreatic cancer patients', '841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period', 'ambulatory pancreatic cancer patients']","['rivaroxaban 10 mg or placebo', 'placebo', 'Rivaroxaban thromboprophylaxis', 'rivaroxaban']","['composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death', 'Major bleeding', 'International Society on Thrombosis and Haemostasis-defined major bleeding', 'VTE or VTE-related death']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",841.0,0.591116,"In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period.","[{'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'The UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.'}, {'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust & Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Venerito', 'Affiliation': 'Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum, Magdeburg, Germany.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Overman', 'Affiliation': 'The UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'The UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA.'}]",Cancer medicine,['10.1002/cam4.3269']
1395,32671719,Cabozantinib for the Treatment of Advanced Hepatocellular Carcinoma: Current Data and Future Perspectives.,"Cabozantinib (Cabometyx ® ) is a potent multikinase inhibitor targeting the vascular endothelial growth factor (VEGF) receptor 2, the mesenchymal-epithelial transition factor (MET) receptor, and the ""anexelekto"" (AXL) receptor tyrosine kinase. It is approved for the treatment of advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since November 2018) and in the USA (since January 2019). The approval of cabozantinib was based on results of the randomized, placebo-controlled, phase 3 CELESTIAL trial in patients with unresectable HCC, who received one or two prior lines of treatment including sorafenib. At the second planned interim analysis, the trial was stopped, because the primary end point overall survival was clearly in favor for cabozantinib. Additionally, median progression-free survival was superior to placebo. The most common ≥ grade 3 relevant adverse events in patients with HCC treated with cabozantinib were palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea. In this review, current data on cabozantinib for the treatment of patients with advanced HCC, with a focus on the management of common adverse events and ongoing clinical trials, are discussed.",2020,"Additionally, median progression-free survival was superior to placebo.","['patients with advanced HCC', 'Advanced Hepatocellular Carcinoma', 'patients with unresectable HCC, who received one or two prior lines of treatment including', 'advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since\xa0November 2018) and in the USA (since January 2019']","['Cabozantinib (Cabometyx ® ', 'sorafenib', 'Cabozantinib', 'placebo']","['palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea', 'overall survival', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237933', 'cui_str': 'Cabometyx'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.065429,"Additionally, median progression-free survival was superior to placebo.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Universitätsklinikum Frankfurt, Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. trojan@em.uni-frankfurt.de.'}]",Drugs,['10.1007/s40265-020-01361-5']
1396,32668012,Sustained improvement of surgical scar appearance 1 year after early intervention with nonablative fractional laser treatment: a randomized controlled split-wound trial.,,2020,The majority of trials addressing early laser intervention for improving scar formation present short follow-up time of 1-3 months 2  .,[],"['nonablative fractional laser treatment', 'laser intervention']","['surgical scar appearance', 'scar formation']",[],"[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0276531,The majority of trials addressing early laser intervention for improving scar formation present short follow-up time of 1-3 months 2  .,"[{'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Grove', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Banzhaf', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Paasch', 'Affiliation': 'Department of Dermatology, Venerology and Allergology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nast', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haedersdal', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Karmisholt', 'Affiliation': 'Department of Dermatology, Bispebjerg University Hospital, Copenhagen, Denmark.'}]",The British journal of dermatology,['10.1111/bjd.19400']
1397,32668087,Associations between resting-state functional connectivity and treatment response in a randomized clinical trial for posttraumatic stress disorder.,"BACKGROUND


Alterations in resting-state functional connectivity (rsFC) have been reported in posttraumatic stress disorder (PTSD). Here, we examined pre- and post-treatment rsFC during a randomized clinical trial to characterize alterations and examine predictors of treatment response.
METHODS


Sixty-four combat veterans with PTSD were randomly assigned to prolonged exposure (PE) plus placebo, sertraline plus enhanced medication management, or PE plus sertraline. Symptom assessment and resting-state functional magnetic resonance imaging (fMRI) scans occurred before and after treatment. Twenty-nine trauma-exposed combat veterans without PTSD served as a control group at intake. Seed-based and region of interest (ROI)-to-ROI connectivities, as well as an exploratory connectome-based approach were used to analyze rsFC patterns. Based on previously reported findings, analyses focused on Salience Network (SN) and Default-Mode Network (DMN).
RESULTS


At intake, patients with PTSD showed greater DMN-dorsal attention network (DAN) connectivity (between ventromedial prefrontal cortex and superior parietal lobule; family-wise error corrected p = .011), greater SN-DAN connectivity (between insula and middle frontal gyrus; corrected p = .003), and a negative correlation between re-experiencing symptoms and within-DMN connectivity (between posterior cingulate cortex (PCC) and middle temporal gyrus; corrected p < .001). We also found preliminary evidence for associations between rsFC and treatment response. Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042).
CONCLUSIONS


Our findings suggest neural abnormalities in PTSD and may inform future research examining neural biomarkers of PTSD treatment response.",2020,"Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042).
","['Twenty-nine trauma-exposed combat veterans without PTSD served as a control group at intake', 'Sixty-four combat veterans with PTSD', 'posttraumatic stress disorder']","['prolonged exposure (PE) plus placebo, sertraline plus enhanced medication management, or PE plus sertraline']","['greater DMN-dorsal attention network (DAN) connectivity', 'Symptom assessment and resting-state functional magnetic resonance imaging (fMRI) scans', 'greater SN-DAN connectivity', 'SN-DMN segregation', 'Salience Network (SN) and Default-Mode Network (DMN']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}]",,0.0394609,"Specifically, high responders (≥50% PTSD symptom improvement), compared with low responders, had greater SN-DMN segregation (i.e., less pre-treatment amygdala-PCC connectivity; p = .011) and lower pre-treatment global centrality (p = .042).
","[{'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Angstadt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Atlanta VA Healthcare System, Decatur, Georgia.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan.'}]",Depression and anxiety,['10.1002/da.23075']
1398,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1399,32675583,Impact of Electroacupuncture Stimulation on Postoperative Constipation for Patients Undergoing Brain Tumor Surgery.,"BACKGROUND


Constipation is frequently encountered in patients undergoing brain tumor resection. Constipation has negative effects on daily living, well-being, and individuals' quality of life. We examined the impact of acupuncture and electroacupuncture (EA) stimulation on postoperative constipation for patients undergoing brain tumor resection.
METHODS


Patients undergoing brain tumor resection (n = 150) were randomly divided into a nontreatment group, an acupuncture group, and an EA group. Rome III Diagnostic Criteria, Cleveland Clinic Constipation Score, symptom assessment, Patient Assessment of Constipation Quality of Life questionnaire, Self-Rating Anxiety Scale, and a Self-Rating Depression Scale were collected.
RESULTS


Acupuncture and EA were effective in relieving postoperative constipation. Electroacupuncture decreased constipation and improved quality of life scores.
CONCLUSION


Acupuncture and EA are novel adjuvant therapies to treat constipation.",2020,"Electroacupuncture decreased constipation and improved quality of life scores.
","['patients undergoing brain tumor resection', 'Patients Undergoing Brain Tumor Surgery', 'Patients undergoing brain tumor resection (n = 150']","['acupuncture', 'acupuncture and electroacupuncture (EA) stimulation', 'Acupuncture and EA', 'Electroacupuncture', 'Electroacupuncture Stimulation']","['relieving postoperative constipation', 'postoperative constipation', 'Rome III Diagnostic Criteria, Cleveland Clinic Constipation Score, symptom assessment, Patient Assessment of', 'constipation and improved quality of life scores', 'Constipation Quality of Life questionnaire, Self-Rating Anxiety Scale, and a Self-Rating Depression Scale', 'Postoperative Constipation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0948179', 'cui_str': 'Postoperative constipation'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3165118', 'cui_str': 'Cleveland Clinic constipation score'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",150.0,0.023133,"Electroacupuncture decreased constipation and improved quality of life scores.
","[{'ForeName': 'Danni', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Danni Li, MSN, is Staff Nurse, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Hui Li, MSN, is Staff Nurse, Department of Spine Surgery, Second Affiliated Hospital of Harbin Medical University. Hongyan Liu, MSN, is Staff Nurse, Department of Nursing, Harbin Medical University Cancer Hospital. Hongbo Bao, PhD, is Surgeon, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Tianming Zhu, BSN, is Nurse, Department of Nursing, First Affiliated Hospital of Harbin Medical University. Jingchen Tian, BSN, is Nurse, Department of Neurosurgery, Harbin the First Hospital. Huiyan Li, MSN, is Staff Nurse, Department of Spine Surgery, Second Affiliated Hospital of Harbin Medical University. Jie Li, BSN, is Nurse, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Xinxin Guo, BSN, is Nurse, Department of Neurosurgery, Harbin Medical University Cancer Hospital. Zhe Zhuang, PhD, is Associate Professor, Hanan Branch of Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Tianming', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Jingchen', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhuang', 'Affiliation': ''}, {'ForeName': 'Guofeng', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000531']
1400,32676977,"A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects.","BACKGROUND


The delta opioid receptor (DOR) has been identified as a therapeutic target for migraine, with DOR agonists exhibiting low abuse potential compared with conventional µ-opioid agonists. TRV250 is a novel small molecule agonist of the DOR that is preferentially selective for G-protein signaling, with relatively little activation of the β-arrestin2 post-receptor signaling pathway. This selectivity provides reduced susceptibility to proconvulsant activity seen with non-selective DOR agonists. TRV250 significantly reduced nitroglycerin-evoked hyperalgesia in rodents, indicating a potential utility in acute migraine without the risk of seizure activity or abuse potential.
OBJECTIVE


This trial evaluated the safety, tolerability, and pharmacokinetics of ascending dose levels of TRV250 administered subcutaneously (SC) and the relative bioavailability of TRV250 administered orally compared with SC administration.
METHODS


This was a two-part, single ascending dose study. Part A included four cohorts of healthy adults (N = 38). Each cohort was dosed on three occasions (placebo and two different dose levels of TRV250, allocated in randomized order and administered by SC route). In Part B, a single cohort of nine subjects received an oral dose of either TRV250 (n = 7) or placebo (n = 2) in a fed or fasted state. Serial blood samples were obtained for pharmacokinetic determination across a 24-h post-dose period. Safety assessments included clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing.
RESULTS


TRV250 was well tolerated. There were no serious adverse events (SAEs), and all AEs were mild in severity. Injection-site reactions and headache were the most common AEs. One subject was withdrawn from the study due to a TRV250-related AE of postural orthostatic tachycardia. There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects. No subject experienced abnormalities in EEGs or experienced a change from baseline in heart-rate-corrected QT interval (QTcF) > 60 ms, or an absolute QTcF interval > 480 ms at any post-dosing observation. Peak and total plasma exposure to TRV250 increased in a dose-proportional manner following 0.1-30 mg SC doses, with the mean half-life ranging from 2.39 to 3.76 h. Oral bioavailability of TRV250 ranged from 14% (fasting) to 19% (fed) relative to SC dosing, while administration with food increased the AUC but decreased the rate of absorption as reflected by a modest delay in median time to maximum concentration and a slight reduction in maximum concentration.
CONCLUSION


The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine.",2020,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","['Part A included four cohorts of healthy adults (N\u2009=\u200938', 'Healthy Subjects']","['occasions (placebo', 'Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist', 'TRV250 administered subcutaneously (SC', 'TRV250', 'placebo']","['clinical laboratory measures, vital signs, 12-lead electrocardiogram (ECG), and electroencephalogram (EEG) pre- and post-dosing', 'absolute QTcF interval\u2009', 'tolerated', 'rate of absorption', 'safety, tolerability, and pharmacokinetics', 'Peak and total plasma exposure to TRV250', 'physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs', 'serious adverse events (SAEs', 'nitroglycerin-evoked hyperalgesia', 'heart-rate-corrected QT interval (QTcF)\u2009']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086376', 'cui_str': 'G protein'}, {'cui': 'C0140057', 'cui_str': 'delta Opioid Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.101361,"There were no clinically relevant changes in physical examination, hematology, clinical chemistry, urinalysis, suicidal ideation, or vital signs, with the exception of orthostatic changes in some subjects.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena, Inc., 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA. mfossler@trevena.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Schmith', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lohmer', 'Affiliation': 'Nuventra Pharma Sciences, Durham, NC, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Scientific Operations and Alliance Management, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Arscott', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'James', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs Department, Trevena Inc, 955 Chesterbrook Boulevard, Suite 110, Chesterbrook, PA, 19087, USA.'}]",CNS drugs,['10.1007/s40263-020-00738-0']
1401,32677106,"Safety and efficacy of (+)-epicatechin in subjects with Friedreich's ataxia: A phase II, open-label, prospective study.","BACKGROUND


(+)-Epicatechin (EPI) induces mitochondrial biogenesis and antioxidant metabolism in muscle fibers and neurons. We aimed to evaluate safety and efficacy of (+)-EPI in pediatric subjects with Friedreich's ataxia (FRDA).
METHODS


This was a phase II, open-label, baseline-controlled single-center trial including 10 participants ages 10 to 22 with confirmed FA diagnosis. (+)-EPI was administered orally at 75 mg/d for 24 weeks, with escalation to 150 mg/d at 12 weeks for subjects not showing improvement of neuromuscular, neurological or cardiac endpoints. Neurological endpoints were change from baseline in Friedreich's Ataxia Rating Scale (FARS) and 8-m timed walk. Cardiac endpoints were changes from baseline in left ventricular (LV) structure and function by cardiac magnetic resonance imaging (MRI) and echocardiogram, changes in cardiac electrophysiology, and changes in biomarkers for heart failure and hypertrophy.
RESULTS


Mean FARS/modified (m)FARS scores showed nonstatistically significant improvement by both group and individual analysis. FARS/mFARS scores improved in 5/9 subjects (56%), 8-m walk in 3/9 (33%), 9-peg hole test in 6/10 (60%). LV mass index by cardiac MRI was significantly reduced at 12 weeks (P = .045), and was improved in 7/10 (70%) subjects at 24 weeks. Mean LV ejection fraction was increased at 24 weeks (P = .008) compared to baseline. Mean maximal septal thickness by echocardiography was increased at 24 weeks (P = .031). There were no serious adverse events.
CONCLUSION


(+)-EPI was well tolerated over 24 weeks at up to 150 mg/d. Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes.
SYNOPSIS


A (+)-epicatechin showed improvement of cardiac function, nonsignificant reduction of FARS/mFARS scores, and sustained significant upregulation of muscle-regeneration biomarker follistatin.",2020,Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes.,"[""pediatric subjects with Friedreich's Ataxia (FRDA"", ""Subjects with Friedreich's Ataxia"", 'ten participants ages 10-22 with confirmed FA diagnosis']","['Epicatechin', 'EPI']","['Mean FARS', 'LV mass index by cardiac MRI', 'Safety and Efficacy', ""Friedreich's Ataxia Rating Scale (FARS) and 8-m timed walk"", 'Mean maximal septal thickness by echocardiography', 'cardiac structure and function', 'left ventricular (LV) structure and function by cardiac MRI and echocardiogram, changes in cardiac electrophysiology, and changes in biomarkers for heart failure and hypertrophy', 'safety and efficacy', 'FARS/mFARS scores', 'Mean LV ejection fraction']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016719', 'cui_str': ""Friedreich's ataxia""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430467', 'cui_str': 'Cardiac electrophysiology'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}]",10.0,0.0379406,Improvement was observed in cardiac structure and function in subset of subjects with FRDA without statistically significant improvement in primary neurological outcomes.,"[{'ForeName': 'Muhammad Yasir', 'Initials': 'MY', 'LastName': 'Qureshi', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Patterson', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Clark', 'Affiliation': 'Center for Individualized Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Johnson', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Moutvic', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Sherilyn W', 'Initials': 'SW', 'LastName': 'Driscoll', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kemppainen', 'Affiliation': 'Department of Clinical Genomics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Huston', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jeff R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Office of Translation to Practice, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Badley', 'Affiliation': 'Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Tebben', 'Affiliation': 'Division of Endocrinology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wackel', 'Affiliation': 'Department of Pediatrics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Oglesbee', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Rochester, Minnesota, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glockner', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Schreiner', 'Affiliation': 'Epirium Bio Inc., San Diego, California, USA.'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Dugar', 'Affiliation': 'Epirium Bio Inc., San Diego, California, USA.'}, {'ForeName': 'Jillienne C', 'Initials': 'JC', 'LastName': 'Touchette', 'Affiliation': 'Superior Medical Experts, St. Paul, Minnesota, USA.'}, {'ForeName': 'Ralitza H', 'Initials': 'RH', 'LastName': 'Gavrilova', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12285']
1402,32678082,Vagus nerve stimulation boosts the drive to work for rewards.,"Interoceptive feedback transmitted via the vagus nerve plays a vital role in motivation by tuning actions according to physiological needs. Whereas vagus nerve stimulation (VNS) reinforces actions in animals, motivational effects elicited by VNS in humans are still largely elusive. Here, we applied non-invasive transcutaneous auricular VNS (taVNS) on the left or right ear while participants exerted effort to earn rewards using a randomized cross-over design (vs. sham). In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards. In contrast, we do not find conclusive evidence that acute taVNS affects effort maintenance or wanting ratings. Collectively, our results suggest that taVNS enhances reward-seeking by boosting invigoration, not effort maintenance and that the stimulation side affects generalization beyond food reward. Thus, taVNS may enhance the pursuit of prospective rewards which may pave avenues to treat motivational deficiencies.",2020,"In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards.",[],"['vagus nerve stimulation (VNS', 'invasive transcutaneous auricular VNS (taVNS']",[],[],"[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}]",[],,0.0294214,"In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards.","[{'ForeName': 'Monja P', 'Initials': 'MP', 'LastName': 'Neuser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kühnel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': 'Department of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Otfried-Müller-Straße 25, 72076, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany. nils.kroemer@uni-tuebingen.de.'}]",Nature communications,['10.1038/s41467-020-17344-9']
1403,32673969,A systematic review and indirect treatment comparison of perampanel versus brivaracetam as adjunctive therapy in patients with focal-onset seizures with or without secondary generalization.,"PURPOSE


To date, there has not been a single randomized controlled trial (RCT) conducted to directly compare the efficacy and safety of perampanel to brivaracetam in the adjunctive treatment of focal-onset seizures. This study makes these comparisons through the use of indirect treatment comparison (ITC) methods.
METHODS


A systematic review was conducted to identify RCTs that evaluated either one of perampanel or brivaracetam in the treatment of patients with focal-onset seizures. The Bucher ITC method was then used to compare efficacy and safety outcomes between perampanel and brivaracetam. Additional subgroup analyses, by levetiracetam usage (prior or concomitant), were conducted.
RESULTS


Eight RCTs (four comparing perampanel to placebo, four comparing brivaracetam to placebo) were included in the ITC. For patients taking concomitant levetiracetam, perampanel showed a significantly better responder rate compared to brivaracetam [relative risk (RR) and 95 % confidence interval (CI): 2.62 (1.15, 5.99)]. For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate. In the overall population, both perampanel and brivaracetam were more effective than placebo in terms of responder rate, seizure freedom, and secondarily generalized tonic-clonic seizure responder rate; however, for these outcomes, no evidence of a difference between perampanel and brivaracetam was found. Patients taking brivaracetam showed significantly less dizziness compared to patients taking perampanel. No differences for any other safety outcome were found.
CONCLUSION


Perampanel and brivaracetam are effective for the adjunctive treatment of focal-onset seizures and display similar adverse event profiles. Perampanel demonstrated an improved focal-onset seizure responder rate compared to brivaracetam in patients taking concomitant levetiracetam. This may be due to the similarity in the mechanism of action between brivaracetam and levetiracetam.",2020,"For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate.","['focal-onset seizures', 'patients with focal-onset seizures with or without secondary generalization', 'patients with focal-onset seizures']","['perampanel', 'perampanel versus brivaracetam', 'perampanel or brivaracetam', 'levetiracetam, perampanel', 'Perampanel', 'placebo']","['efficacy and safety outcomes', 'dizziness', 'responder rate', 'responder rate, seizure freedom, and secondarily generalized tonic-clonic seizure responder rate', 'efficacy and safety', 'focal-onset seizure responder rate']","[{'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}]",,0.188512,"For patients who had previously, or never, taken levetiracetam, there was no difference in the responder rate.","[{'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Trinka', 'Affiliation': 'FRCP Department of Neurology, Christian Doppler University Hospital, Paracelsus Medical University, Harrerstrasse 79, A-5020, Salzburg, Austria. Electronic address: eugen@trinka.at.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Tsong', 'Affiliation': 'Formerly Eisai Inc, 100 Tice Blvd, Woodcliff Lake, NJ, 07677, United States. Electronic address: wtsong.esi@gmail.com.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Toupin', 'Affiliation': 'Quantics Biostatistics, Exchange Tower, 19 Canning Street Fourth Floor, Edinburgh, EH3 8EG, United Kingdom. Electronic address: sydney.toupin@outlook.com.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd. European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'York Health Economics Consortium, Enterprise House, Innovation Way, University of York, York, YO10 5NQ, United Kingdom. Electronic address: katy.wilson@york.ac.uk.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Isojarvi', 'Affiliation': 'York Health Economics Consortium, Enterprise House, Innovation Way, University of York, York, YO10 5NQ, United Kingdom. Electronic address: jaana.isojarvi@york.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'James', 'Affiliation': 'Quantics Biostatistics, Exchange Tower, 19 Canning Street Fourth Floor, Edinburgh, EH3 8EG, United Kingdom. Electronic address: Daniel.James@quantics.co.uk.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106403']
1404,32673171,Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With  FLT3 -Internal Tandem Duplication Mutation (SORMAIN).,"PURPOSE


Despite undergoing allogeneic hematopoietic stem cell transplantation (HCT), patients with acute myeloid leukemia (AML) with internal tandem duplication mutation in the  FMS- like tyrosine kinase 3 gene ( FLT3- ITD) have a poor prognosis, frequently relapse, and die as a result of AML. It is currently unknown whether a maintenance therapy using FLT3 inhibitors, such as the multitargeted tyrosine kinase inhibitor sorafenib, improves outcome after HCT.
PATIENTS AND METHODS


In a randomized, placebo-controlled, double-blind phase II trial (SORMAIN; German Clinical Trials Register: DRKS00000591), 83 adult patients with  FLT3- ITD-positive AML in complete hematologic remission after HCT were randomly assigned to receive for 24 months either the multitargeted and FLT3-kinase inhibitor sorafenib (n = 43) or placebo (n = 40 placebo). Relapse-free survival (RFS) was the primary endpoint of this trial. Relapse was defined as relapse or death, whatever occurred first.
RESULTS


With a median follow-up of 41.8 months, the hazard ratio (HR) for relapse or death in the sorafenib group versus placebo group was 0.39 (95% CI, 0.18 to 0.85; log-rank  P  = .013). The 24-month RFS probability was 53.3% (95% CI, 0.36 to 0.68) with placebo versus 85.0% (95% CI, 0.70 to 0.93) with sorafenib (HR, 0.256; 95% CI, 0.10 to 0.65; log-rank  P  = .002). Exploratory data show that patients with undetectable minimal residual disease (MRD) before HCT and those with detectable MRD after HCT derive the strongest benefit from sorafenib.
CONCLUSION


Sorafenib maintenance therapy reduces the risk of relapse and death after HCT for  FLT3- ITD-positive AML.",2020,", the hazard ratio (HR) for relapse or death in the sorafenib group versus placebo group was 0.39 (95% CI, 0.18 to 0.85; log-rank  P  = .013).","['ITD-positive AML in complete hematologic remission after HCT', '83 adult patients with', 'patients with acute myeloid leukemia (AML) with internal tandem duplication mutation']","['multitargeted and FLT3-kinase inhibitor sorafenib', 'Sorafenib Maintenance', 'FLT3', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'allogeneic hematopoietic stem cell transplantation (HCT', 'Sorafenib maintenance therapy', 'placebo']","['relapse or death', '24-month RFS probability', 'Relapse-free survival (RFS', 'hazard ratio (HR) for relapse or death', 'Relapse', 'risk of relapse and death']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",83.0,0.554634,", the hazard ratio (HR) for relapse or death in the sorafenib group versus placebo group was 0.39 (95% CI, 0.18 to 0.85; log-rank  P  = .013).","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Burchert', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Bug', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Lea V', 'Initials': 'LV', 'LastName': 'Fritz', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Finke', 'Affiliation': 'Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Department of Medicine A/Hematology and Oncology, University of Muenster, Münster, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Röllig', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Wollmer', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wäsch', 'Affiliation': 'Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bornhäuser', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Berg', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Lang', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ehninger', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zeiser', 'Affiliation': 'Department of Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Freiburg University Medical Center, Freiburg, Germany.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Wagner', 'Affiliation': 'Medical Department III, Hematology, Medical Oncology and Pneumology, University Mainz, Germany.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wolschke', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schleuning', 'Affiliation': 'German Clinic for Diagnostics, Helios Clinic, Wiesbaden, Germany.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Götze', 'Affiliation': 'Department of Medicine III, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmid', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crysandt', 'Affiliation': 'Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Eßeling', 'Affiliation': 'Department of Medicine A/Hematology and Oncology, University of Muenster, Münster, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Wolf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Bonn, Bonn, Germany; and Department of Hematology and Oncology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Böhm', 'Affiliation': 'Department of Hematology/Oncology/Stem Cell Transplantation, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medical Department I, University Hospital Carl Gustav Carus, Technische Universitat Dresden, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Haferlach', 'Affiliation': 'Munich Leukemia Laboratory, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Michel', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Bethge', 'Affiliation': 'University of Tuebingen Medical Center, Tuebingen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wündisch', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandts', 'Affiliation': 'Department of Medicine 2, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Harnisch', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wittenberg', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Heinz-Gert', 'Initials': 'HG', 'LastName': 'Hoeffkes', 'Affiliation': 'Tumorklinik (Medizinische Onkologie, Palliativmedizin, Hämatologie und Hämostasiologie), Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rospleszcz', 'Affiliation': 'Chair of Genetic Epidemiology, Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, Faculty of Medicine, Ludwigs Maximilian Universität München and Institute of Genetic Epidemiology, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Burchardt', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, University Hospital Gießen and Marburg, Campus Gießen, Gießen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Brugger', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, Faculty of Medicine, Ludwigs Maximilian Universität München and Institute of Genetic Epidemiology, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany and Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Strauch', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung Biometrie und Epidemiologie, Faculty of Medicine, Ludwigs Maximilian Universität München and Institute of Genetic Epidemiology, Helmholtz Zentrum München - German Research Center for Environmental Health, Neuherberg, Germany and Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Stephan K', 'Initials': 'SK', 'LastName': 'Metzelder', 'Affiliation': 'Department of Internal Medicine, Hematology, Oncology and Immunology, Philipps University Marburg and University Hospital Gießen and Marburg, Campus Marburg, Marburg, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03345']
1405,32678852,The effect of comprehensive intervention for childhood obesity on dietary diversity among younger children: Evidence from a school-based randomized controlled trial in China.,"BACKGROUND


Little evidence from developing countries on dietary transition demonstrates the effects of comprehensive childhood obesity interventions on dietary diversity and food variety among younger children. This study aimed to evaluate the effects of comprehensive childhood obesity interventions on dietary diversity among younger children.
METHODS


A total of 4846 children aged 7-13 years were included based on a multicenter randomized controlled trial for childhood obesity interventions in 38 primary schools. Nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention including both NE and PA (CNP) were carried out separately for 2 semesters. Dietary Diversity Score (DDS9 and DDS28 for 9 and 28 food groupings, respectively), Food Variety Score (FVS, the number of food items) and the proportions of different foods consumed were calculated according to the food intake records collected with the 24-h dietary recall method.
RESULTS


The intervention effects per day of comprehensive intervention group were 0 (95% Confidence Interval (CI): 0, 0.1; p = 0.382) on DDS9, 0.1 (95% CI: -0.1, 0.2; p = 0.374) on DDS28 and 0.1 (95% CI: -0.1, 0.3; p = 0.186) on FVS of overall diet, which was 0.1 (95% CI: 0, 0.1; p < 0.001) on DDS9, 0 (95% CI: 0, 0.1; p = 0.168) on DDS28 and 0.1 (95% CI: 0, 0.1; p = 0.067) on FVS of dietary scores of breakfast only. Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group. Decreasing side effect on dietary diversity and food variety were found for PA intervention, but not for NE intervention only.
CONCLUSIONS


Though the comprehensive obesity intervention didn't improve the overall dietary diversity per day, the positive intervention effects were observed on breakfast foods and some foods' consumption.",2020,"Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group.","['younger children', '4846 children aged 7-13 years', '38 primary schools']","['comprehensive childhood obesity interventions', 'childhood obesity interventions', 'comprehensive intervention', 'Nutrition education intervention (NE), physical activity intervention (PA) and comprehensive intervention including both NE and PA (CNP', 'CNP']","['Dietary Diversity Score (DDS9 and DDS28', 'FVS of dietary scores', 'dietary diversity', 'Food Variety Score ', 'cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions', 'FVS of overall diet', 'overall dietary diversity']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1511518', 'cui_str': 'Copy Number Polymorphisms'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0236026', 'cui_str': 'Fetal valproate syndrome'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",4846.0,0.0989589,"Additionally, CNP group had greater increases in cereals, meat and fruits, and more decreases in eggs, fish and dried legumes consumption proportions as compared with the control group.","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Ecker', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing, China.'}, {'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Tingyu', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""Chongqing Children's Hospital, Chongqing, China.""}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Harbin Medical University, Harbin, China.'}, {'ForeName': 'Guifa', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Public Health, Shandong University, Jinan, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Guangzhou Center for Disease Control and Prevention, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Junmao', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing, China.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing, China.'}]",PloS one,['10.1371/journal.pone.0235951']
1406,32687266,A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study.,"Eflapegrastim (Rolontis ®  ) is a novel, long-acting hematopoietic growth factor consisting of a recombinant human granulocyte-colony stimulating factor (rhG-CSF) analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. We report results from a second pivotal, randomized, open-label, Phase 3 study comparing the efficacy and safety of eflapegrastim to pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. Patients with Stage I to IIIA early-stage breast cancer (ESBC) were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or pegfilgrastim (6 mg G-CSF) administered one day after standard docetaxel/cyclophosphamide (TC) therapy for four cycles. The primary objective was to demonstrate noninferiority (NI) of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN; Grade 4) in Cycle 1. A total of 237 eligible patients were randomized 1:1 to receive either eflapegrastim (n = 118) or pegfilgrastim (n = 119). Cycle 1 severe neutropenia was observed in 20.3% (n = 24) of patients receiving eflapegrastim and 23.5% (n = 28) receiving pegfilgrastim. The DSN of eflapegrastim in Cycle 1 was noninferior to pegfilgrastim with a mean difference of -0.074 days (NI P-value < .0001). Noninferiority was maintained throughout the four treatment cycles (P < .0001 in all cycles). Other efficacy endpoints results were comparable between treatment arms, and adverse events, irrespective of causality and grade, were comparable between treatment arms. The results demonstrate noninferior efficacy and comparable safety for eflapegrastim, at a lower G-CSF dose, vs pegfilgrastim. The potential for the increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study.",2020,Noninferiority was maintained throughout the four treatment cycles (P < .0001 in all cycles).,"['Patients with Stage I to IIIA early-stage breast cancer (ESBC', 'patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER', '237 eligible patients']","['pegfilgrastim', 'pegfilgrastim (6\xa0mg G-CSF', 'Eflapegrastim (Rolontis ®  ', 'eflapegrastim 13.2\xa0mg', 'docetaxel/cyclophosphamide (TC) therapy', 'eflapegrastim to pegfilgrastim', 'eflapegrastim']","['adverse events, irrespective of causality and grade', 'Cycle 1 severe neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C4076002', 'cui_str': 'Cyclophosphamide therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",237.0,0.0235253,Noninferiority was maintained throughout the four treatment cycles (P < .0001 in all cycles).,"[{'ForeName': 'Patrick Wayne', 'Initials': 'PW', 'LastName': 'Cobb', 'Affiliation': ""St. Vincent's Frontier Cancer Center, Frontier Cancer Center, Billings, MT, USA.""}, {'ForeName': 'Yong Wha', 'Initials': 'YW', 'LastName': 'Moon', 'Affiliation': 'CHA Bundang Medical Center, Seongnam, Korea.'}, {'ForeName': 'Klára', 'Initials': 'K', 'LastName': 'Mezei', 'Affiliation': 'Szabolcs-Szatmár - Bereg County Hospital, Nyíregyháza, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Bhat', 'Affiliation': 'Spectrum Pharmaceuticals, Inc, Irvine, CA, USA.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Chawla', 'Affiliation': 'Spectrum Pharmaceuticals, Inc, Irvine, CA, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Hasal', 'Affiliation': 'Spectrum Pharmaceuticals, Inc, Irvine, CA, USA.'}, {'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Schwartzberg', 'Affiliation': 'West Cancer Center, Germantown, TN, USA.'}]",Cancer medicine,['10.1002/cam4.3227']
1407,32694162,Effect of Ferric Citrate versus Ferrous Sulfate on Iron and Phosphate Parameters in Patients with Iron Deficiency and CKD: A Randomized Trial.,"BACKGROUND AND OBJECTIVES


Ferric citrate is an oral medication approved for treatment of iron deficiency anemia in patients with CKD not requiring dialysis. The relative efficacy of ferric citrate versus ferrous sulfate in treating iron deficiency in patients with CKD is unclear.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


We randomized 60 adults with moderate to severe CKD (eGFR 15-45 ml/min per 1.73 m 2 ) and iron deficiency (transferrin saturation [TSAT] ≤30% and ferritin ≤300 ng/ml) to ferric citrate (2 g three times a day with meals,  n =30) or ferrous sulfate (325 mg three times a day,  n =30) for 12 weeks. Primary outcomes were change in TSAT and ferritin from baseline to 12 weeks. Secondary outcomes were change in hemoglobin, fibroblast growth factor 23 (FGF23), and hepcidin.
RESULTS


Baseline characteristics were well balanced between study arms. There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15;  P =0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64;  P =0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate. Similarly, as compared with ferrous sulfate, treatment with ferric citrate resulted in a greater increase in hepcidin from baseline to 12 weeks (between-group difference, 69 pg/ml; 95% CI, 8 to 130). There were no between-group differences in mean change for hemoglobin (0.3 g/dl; 95% CI, -0.2 to 0.8), intact FGF23 (-29 pg/ml; 95% CI, -59 to 0.1), or C-terminal FGF23 (61 RU/ml; 95% CI, -181 to 58). The incidence of adverse events did not differ between treatment arms.
CONCLUSIONS


As compared with ferrous sulfate, treatment with ferric citrate for 12 weeks resulted in a greater mean increase in TSAT and ferritin concentrations in individuals with moderate to severe CKD and iron deficiency.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With Moderate to Severe Chronic Kidney Disease (CKD) With Iron Deficiency, NCT02888171.",2020,"There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15;  P =0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64;  P =0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate.","['60 adults with moderate to severe CKD (eGFR 15-45 ml/min per 1.73 m 2 ) and iron deficiency (transferrin saturation [TSAT] ≤30% and ferritin ≤300 ng/ml) to', 'individuals with moderate to severe CKD and iron deficiency', 'patients with CKD not requiring dialysis', 'Individuals With Moderate to Severe Chronic Kidney Disease (CKD', 'patients with CKD', 'Patients with Iron Deficiency and CKD']","['Ferric Citrate versus Ferrous Sulfate', 'ferric citrate', 'ferrous sulfate', 'Ferric Citrate vs Ferrous Sulfate', 'ferric citrate (2 g three times a day with meals,  n =30) or ferrous sulfate', 'ferric citrate versus ferrous sulfate']","['mean change for hemoglobin', 'TSAT', 'change in TSAT and ferritin', 'TSAT and ferritin concentrations', 'ferritin', 'hepcidin', 'change in hemoglobin, fibroblast growth factor 23 (FGF23), and hepcidin', 'intact FGF23', 'incidence of adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0060231', 'cui_str': 'ferric citrate'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C4553624', 'cui_str': 'With meals'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C3272931', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.220652,"There was a greater increase in TSAT (between-group difference in mean change, 8%; 95% confidence interval [95% CI], 1 to 15;  P =0.02) and ferritin (between-group difference in mean change, 37 ng/ml; 95% CI, 10 to 64;  P =0.009) from baseline to 12 weeks in participants randomized to ferric citrate as compared with ferrous sulfate.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Womack', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Berru', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Bhupesh', 'Initials': 'B', 'LastName': 'Panwar', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Orlando M', 'Initials': 'OM', 'LastName': 'Gutiérrez', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama ogutierrez@uabmc.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15291219']
1408,32699918,The effect of melatonin on reduction in the need for sedative agents and duration of mechanical ventilation in traumatic intracranial hemorrhage patients: a randomized controlled trial.,"PURPOSE


This study aimed to determine the effect of exogenous melatonin on the number of sedative drugs and the duration of mechanical ventilation in traumatic intracranial hemorrhage patients in ICU.
METHODS


This double-blind randomized clinical trial study was conducted in the ICU wards of Golestan Hospital, Ahvaz, Iran, from September 2017 to March 2018. In this study, 52 patients with intracerebral hemorrhage were selected by convenient sampling (26 patients in each group) and were randomly assigned to two groups of melatonin and control. Sedation and pain management package was applied to both groups.
OUTCOMES


Amount of the sedative and opioid drug; mechanical ventilation time; ICU staying time; Glasgow Coma Score; hemodynamic parameters.
RESULTS


There was no significant difference between them in terms of demographic characteristics. Cumulative doses of morphine and mechanical ventilation time were significant in two groups. (P < 0.05) The mean length of ICU staying was not significant. Glasgow Coma Score on the 6th day was significant in two groups (P < 0.05). Diastolic blood pressure was significant between groups (P < 0.001).
CONCLUSION


This study presented that morphine consumption and mechanical ventilation time were significantly lower in the melatonin group than in the control. Also, rise in GCS in the melatonin group was faster in the melatonin group than in the control. The use of melatonin can be recommended for patients with ICH in the ICU for better outcomes.",2020,Glasgow Coma Score on the 6th day was significant in two groups (P < 0.05).,"['traumatic intracranial hemorrhage patients', 'ICU wards of Golestan Hospital, Ahvaz, Iran, from September 2017 to March 2018', 'patients with ICH in the ICU for better outcomes', 'traumatic intracranial hemorrhage patients in ICU', '52 patients with intracerebral hemorrhage were selected by convenient sampling (26 patients in each group']","['morphine', 'melatonin', 'exogenous melatonin', 'melatonin and control']","['sedative and opioid drug; mechanical ventilation time; ICU staying time; Glasgow Coma Score; hemodynamic parameters', 'Diastolic blood pressure', 'mechanical ventilation time', 'morphine consumption and mechanical ventilation time', 'Glasgow Coma Score', 'mean length of ICU staying', 'rise in GCS']","[{'cui': 'C0273058', 'cui_str': 'Intracranial hemorrhage following injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",52.0,0.0797376,Glasgow Coma Score on the 6th day was significant in two groups (P < 0.05).,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Soltani', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Salari', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Javaherforooshzadeh', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. f_javaherforoosh@yahoo.com.'}, {'ForeName': 'Nozar', 'Initials': 'N', 'LastName': 'Nassajjian', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farahmand', 'Initials': 'F', 'LastName': 'Kalantari', 'Affiliation': 'Department of Anesthesia, Ahvaz Anesthesiology and Pain Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",European journal of trauma and emergency surgery : official publication of the European Trauma Society,['10.1007/s00068-020-01449-3']
1409,32700655,Incidence of silent venous thromboembolism after total hip arthroplasty: A comparison of rivaroxaban and enoxaparin.,"PROPOSE


Total hip arthroplasty (THA) is associated with a significant risk of venous thromboembolism (VTE). Different thromboprophylaxis strategies have been used to prevent VTE. The primary aim of this study was to report the incidence of VTE and compare the efficacy and safety of rivaroxaban to enoxaparin. The secondary outcome was to report the incidence of silent deep venous thrombosis (DVT) using computed tomography venography.
METHODS


One hundred sixty patients who underwent THA were enrolled in a prospective study. Patients were randomized into two groups as follows: those who received rivaroxaban 10 mg oral daily (group RXE) and those who received enoxaparin 40 IU/day subcutaneously for 14 days (group ENO).
RESULTS


Both groups were matched for age, sex, comorbidities, special habits and preoperative laboratory investigations. The overall incidence of DVT was 5% ( n  = 8), which included four patients clinically diagnosed as having DVT and four with silent DVT. All the DVT cases occurred in veins below the knee and in the group RXE; none of the cases occurred in group ENO ( p  = 0.04). The incidence of DVT was significantly higher in patients with high body mass indexes ( p  < 0.001), older age ( p  = 0.024) and medical comorbidities ( p  = 0.14). No mortality, pulmonary embolism, stroke, wound infection or major bleeding occurred in either group.
CONCLUSIONS


Among the patients who underwent hip arthroplasty, rivaroxaban prophylaxis was found to be associated with lower efficacy and similar safety outcomes as compared with enoxaparin anticoagulants.",2020,"The incidence of DVT was significantly higher in patients with high body mass indexes ( p  < 0.001), older age ( p  = 0.024) and medical comorbidities ( p  = 0.14).","['One hundred sixty patients who underwent THA were enrolled in a prospective study', 'total hip arthroplasty']","['rivaroxaban', 'enoxaparin', 'rivaroxaban prophylaxis', 'rivaroxaban and enoxaparin']","['overall incidence of DVT', 'No mortality, pulmonary embolism, stroke, wound infection or major bleeding', 'incidence of silent deep venous thrombosis (DVT', 'Incidence of silent venous thromboembolism', 'efficacy and safety', 'medical comorbidities', 'incidence of DVT']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",160.0,0.0228021,"The incidence of DVT was significantly higher in patients with high body mass indexes ( p  < 0.001), older age ( p  = 0.024) and medical comorbidities ( p  = 0.14).","[{'ForeName': 'Wael A', 'Initials': 'WA', 'LastName': 'Rahman', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Gamal H', 'Initials': 'GH', 'LastName': 'Habsa', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'Al-Mohrej', 'Affiliation': 'Department of orthopedics, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hammad', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Naser M', 'Initials': 'NM', 'LastName': 'Selim', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Hammad', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020938865']
1410,32674956,Effect of high-intensity training on peak oxygen uptake and muscular strength after lung transplantation: A randomized controlled trial.,"BACKGROUND


Peak oxygen uptake (VO 2peak ) remains low after lung transplantation (LTx). We evaluated the effect of high-intensity interval training (HIIT) on VO 2peak , muscular strength, health-related quality of life (HRQOL), pulmonary function, and physical function after LTx.
METHODS


In this randomized controlled trial, 54 participants were enrolled from 6 to 60 months after LTx. The HIIT group (n = 25) followed a supervised HIIT program, consisting of endurance and strength trainings 3 times a week for 20 weeks. The control group (n = 29) received usual care. The primary outcome was a change in VO 2peak  measured by cardiopulmonary exercise testing. The secondary outcomes were changes in 1-repetition maximum (1RM) for arm press and leg press, HRQOL (36-Item Short-Form Health Survey [SF-36]), pulmonary function (forced expiratory volume in 1 sec, diffusing capacity of the lungs for carbon monoxide), and physical function (1RM in handgrip, 15-sec stair run, and 30-sec chair stand).
RESULTS


A total of 46 participants completed the study, including 23 of 25 in the intervention group. For the primary outcome, the intention-to-treat analysis revealed a non-significant between-group difference for change in VO 2peak  of 0.7 ml/(kg.min) (95% CI = ‒0.3, 1.8) (p = 0.17). The between-group differences for 1RM arm press and leg press and mental aspect of SF-36 were 4.9 kg (95% CI = ‒0.1, 9.9) (p = 0.05), 11.6 kg (95% CI = 0.1, 23.0) (p < 0.05), and 5.7 kg (95% CI = 0.9, 10.4) (p = 0.02), respectively. There were no between-group differences in pulmonary function or physical function. When excluding participants with an attendance of <70% (n = 16), the between-group difference for VO 2peak  was 1.2 ml/(kg.min) (95% CI = 0.1, 2.4) (p = 0.032).
CONCLUSIONS


HIIT improved muscular strength and HRQOL but did not improve VO 2peak  more than usual care after LTx. However, with acceptable adherence, HIIT appears to have beneficial effects on VO 2peak .",2020,"For the primary outcome, the intention-to-treat analysis revealed a non-significant between-group difference for change in VO 2peak  of 0.7 ml/(kg.min)","['46 participants completed the study, including 23 of 25 in the intervention group', '54 participants were enrolled from 6 to 60 months after LTx', 'after lung transplantation']","['supervised HIIT program, consisting of endurance and strength trainings', 'usual care', 'high-intensity interval training (HIIT', 'high-intensity training']","['peak oxygen uptake and muscular strength', 'pulmonary function or physical function', 'VO 2peak , muscular strength, health-related quality of life (HRQOL), pulmonary function, and physical function after LTx', 'intention-to-treat analysis', 'change in VO 2peak  measured by cardiopulmonary exercise testing', '1RM arm press and leg press and mental aspect of SF-36', 'changes in 1-repetition maximum (1RM) for arm press and leg press, HRQOL (36-Item Short-Form Health Survey [SF-36]), pulmonary function (forced expiratory volume in 1 sec, diffusing capacity of the lungs for carbon monoxide), and physical function (1RM in handgrip, 15-sec stair run, and 30-sec chair stand', 'muscular strength and HRQOL']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024128', 'cui_str': 'Transplant of lung'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1135599', 'cui_str': 'mental aspects'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}]",54.0,0.236441,"For the primary outcome, the intention-to-treat analysis revealed a non-significant between-group difference for change in VO 2peak  of 0.7 ml/(kg.min)","[{'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Ulvestad', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: mariannulv@gmail.com.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Durheim', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Johny S', 'Initials': 'JS', 'LastName': 'Kongerud', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'May B', 'Initials': 'MB', 'LastName': 'Lund', 'Affiliation': 'Department of Respiratory Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Edvardsen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport and Sciences, Oslo, Norway; Department of Pulmonary Medicine, Oslo University Hospital Ullevål, Oslo, Norway.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.06.006']
1411,32675474,Characterization of resting and exercise inter-arm differences in SBP to isometric handgrip exercise in males and females.,"A large inter-arm difference (IAD; ≥10 mmHg) in SBP is linked to cardiovascular and peripheral vascular disease, hypertension, and premature mortality. Exercise-induced IAD (eIAD) is related to resting IAD, and acute aerobic activity alters eIAD and reduces IAD in recovery. Isometric handgrip exercise (IHE) affects blood pressure (BP), though the eIAD response to IHE is unknown. Further, the eIAD response may differ between males and females.
OBJECTIVES


To characterize the eIAD response to IHE in males and females.
METHODS


On visit 1, participants (16 females and 15 males, aged 18-35 years) completed three maximal voluntary isometric contractions (MVIC) per arm. On visit 2, before IHE, a series of three simultaneous, bilateral BP measures were averaged at rest. During IHE, participants maintained handgrip at 20% of MVIC for 2 minutes (arm randomly assigned), at which time bilateral BP was measured (IHE) during exercise and subsequent recovery (REC1 and REC2). Repeated-measures analysis of variance assessed eIAD and SBP (time × sex).
RESULTS


IHE increased absolute eIAD (4 mmHg). Differences in relative eIAD were observed at IHE and REC2 based on resting IAD status (P < 0.05). Females only had an exaggerated SBP and pulse pressure response in the working arm.
CONCLUSION


Acute IHE was shown to augment eIAD. Further eIAD and resting IAD were related. Acute IHE induced different bilateral responses between males and females, though the impact of sex on eIAD warrants further investigation. Future studies should address the effects of repeated bouts of IHE, which may benefit individuals with a large resting IAD.",2020,Differences in relative eIAD were observed at IHE and REC2 based on resting IAD status (P < 0.05).,"['participants (16 females and 15 males, aged 18-35 years', 'males and females']","['Isometric handgrip exercise (IHE', 'isometric handgrip exercise', 'maximal voluntary isometric contractions (MVIC', 'Exercise-induced IAD (eIAD']","['relative eIAD', 'absolute eIAD', 'bilateral BP measures', 'resting IAD status', 'blood pressure (BP', 'eIAD and SBP (time × sex', 'bilateral responses', 'exaggerated SBP and pulse pressure response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0022230', 'cui_str': 'Inosine Pranobex'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022230', 'cui_str': 'Inosine Pranobex'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}]",,0.0394639,Differences in relative eIAD were observed at IHE and REC2 based on resting IAD status (P < 0.05).,"[{'ForeName': 'Brock T', 'Initials': 'BT', 'LastName': 'Jensen', 'Affiliation': 'Department of Exercise and Rehabilitative Sciences, Slippery Rock University, Slippery Rock, Pennsylvania, USA.'}, {'ForeName': 'Benjamin D H', 'Initials': 'BDH', 'LastName': 'Gordon', 'Affiliation': ''}, {'ForeName': 'Lance S', 'Initials': 'LS', 'LastName': 'Neuscheler', 'Affiliation': ''}, {'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Ace', 'Affiliation': ''}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Borland', 'Affiliation': ''}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Holmstrup', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000465']
1412,32675475,Postural blood pressure changes in the elderly: orthostatic hypotension and hypertension.,"OBJECTIVES


Orthostatic hypotension is a well-known disorder, but orthostatic hypertension (OHT) still remains unclear in older adults. The aim of this study was to determine the comparison orthostatic hypotension with OHT according to fall risk and geriatric assessment parameters.
METHODS


A total of 741 patients who were admitted to the geriatric clinic and underwent comprehensive geriatric assessment were reviewed. Orthostatic blood pressure changes were measured by head-up-tilt Table test within the first three minutes. Orthostatic hypotension was defined as 20 or 10-mmHg drop in systolic and/or diastolic blood pressure from supine to standing position. OHT was defined as an increase in systolic blood pressure of 10 mmHg or more while the patient was standing up from the supine position.
RESULTS


The mean age was 75 ± 8 and 65. About 65% of all participants were female. The rate of orthostatic hypotension and OHT was 17.3 and 7.2%, respectively. The falls and dementia were more frequent, and the Instrumental Activities of Daily Living (IADL) score was lower in orthostatic hypotension group than in OHT and control groups (P < 0.05). These variables were similar between OHT and control groups (P > 0.05). The rates of falls [odds ratio (OR) = 2.02; 95% confidence interval (CI), (0.94-4.33); P = 0.044] and dementia [OR = 2.65; 95% CI, (1.08-6.48); P = 0.032] in orthostatic hypotension group were still higher than in OHT group, even after adjusting for age, sex, estimated glomerular filtration rate and drugs.
CONCLUSION


Orthostatic hypotension may be more significant in terms of falls, dementia and impaired IADLs scores in older adults than in OHT and control groups. It seems that OHT may be of no clinical importance in geriatric practice.",2020,"The falls and dementia were more frequent, and the Instrumental Activities of Daily Living (IADL) score was lower in orthostatic hypotension group than in OHT and control groups (P < 0.05).","['elderly: orthostatic hypotension and hypertension', 'The mean age was 75\u2009±\u20098 and 65', 'older adults', '741 patients who were admitted to the geriatric clinic and underwent comprehensive geriatric assessment were reviewed', 'older adults than in OHT and control groups']",[],"['rates of falls [odds ratio', 'Instrumental Activities of Daily Living (IADL) score', 'Postural blood pressure changes', 'orthostatic hypotension', 'Orthostatic blood pressure changes', 'Orthostatic hypotension', 'systolic blood pressure', 'falls and dementia', 'systolic and/or diastolic blood pressure', 'rate of orthostatic hypotension and OHT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}]",741.0,0.0233568,"The falls and dementia were more frequent, and the Instrumental Activities of Daily Living (IADL) score was lower in orthostatic hypotension group than in OHT and control groups (P < 0.05).","[{'ForeName': 'Suleyman Emre', 'Initials': 'SE', 'LastName': 'Kocyigit', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Neziha', 'Initials': 'N', 'LastName': 'Erken', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Dokuzlar', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Fatma Sena', 'Initials': 'FS', 'LastName': 'Dost Gunay', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Ates Bulut', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Ali Ekrem', 'Initials': 'AE', 'LastName': 'Aydin', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Soysal', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ahmet Turan', 'Initials': 'AT', 'LastName': 'Isik', 'Affiliation': 'Department of Geriatric Medicine, Faculty of Medicine, Dokuz Eylul University, Izmir.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000466']
1413,32676679,Health-related quality of life in survivors of septic shock: 6-month follow-up from the ADRENAL trial.,"PURPOSE


To investigate the impact of hydrocortisone treatment and illness severity on health-related quality of life (HRQoL) at 6 months in septic shock survivors from the ADRENAL trial.
METHODS


Using the EuroQol questionnaire (EQ-5D-5L) at 6 months after randomization we assessed HRQoL in patient subgroups defined by hydrocortisone or placebo treatment, gender, illness severity (APACHE II < or ≥ 25), and severity of shock (baseline peak catecholamine doses < or ≥ 15 mcg/min). Additionally, in subgroups defined by post-randomisation variables; time to shock reversal (days), treatment with renal replacement therapy (RRT), and presence of bacteremia.
RESULTS


At 6 months, there were 2521 survivors. Of these 2151 patients (85.3%-1080 hydrocortisone and 1071 placebo) completed 6-month follow-up. Overall, at 6 months the mean EQ-5D-5L visual analogue scale (VAS) was 70.8, mean utility score 59.4. Between 15% and 30% of patients reported moderate to severe problems in any given HRQoL domain. There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611). In all patients combined, males experienced lower pain levels compared to females [p = 0.0002). Neither higher severity of illness or shock impacted reported HRQoL. In post-randomisation subgroups, longer time to shock reversal was associated with increased problems with mobility (p = < 0.0001]; self-care (p = 0.0.0142), usual activities (p = <0.0001] and pain (p = 0.0384). Amongst those treated with RRT, more patients reported increased problems with mobility (p = 0.0307) and usual activities (p = 0.0048) compared to those not treated. Bacteraemia was not associated with worse HRQoL in any domains of the EQ-5D-5L.
CONCLUSIONS


Approximately one fifth of septic shock survivors report moderate to extreme problems in HRQoL domains at 6 months. Hydrocortisone treatment for septic shock was not associated with improved HRQoL at 6 months. Female gender was associated with worse pain at 6 months.",2020,"There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611).","['septic shock survivors', 'survivors of septic shock', '2151 patients (85.3%-1080']","['RRT', 'hydrocortisone', 'Hydrocortisone', 'hydrocortisone vs. placebo', 'hydrocortisone or placebo', 'hydrocortisone and 1071 placebo', 'EuroQol questionnaire\xa0(EQ-5D-5L']","['health-related quality of life (HRQoL', 'usual activities', 'problems with mobility', 'moderate to severe problems', 'worse pain', 'mean EQ-5D-5L visual analogue scale (VAS', 'pain levels', 'pain', 'EQ-5D-5L domain', 'longer time to shock reversal', 'renal replacement therapy (RRT), and presence of bacteremia', 'mean\xa0VAS', 'mean utility score']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5192768', 'cui_str': '1080'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.531361,"There were no differences in any EQ-5D-5L domain in patients who received hydrocortisone vs. placebo, nor in the mean VAS (p = 0.6161), or mean utility score (p = 0.7611).","[{'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia. nhammond@georgeinstitute.org.au.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Finfer', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Austin and Repatriation Medical Center, Melbourne, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Harward', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Dorrilyn', 'Initials': 'D', 'LastName': 'Rajbhandari', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rhodes', 'Affiliation': ""St. George's Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Webb', 'Affiliation': 'Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'Statistics Division, The George Institute for Global Health, UNSW Sydney, Newtown, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06169-1']
1414,32673356,Comparing feasibility of low-tube-voltage protocol with low-iodine-concentration contrast and high-tube-voltage protocol with high-iodine-concentration contrast in coronary computed tomography angiography.,"BACKGROUND


To investigate the feasibility of a low tube voltage (80 kVp) protocol with low concentration contrast media (CM) (iodixanol 320 mgl/ml) as compared with a high tube voltage (100 kVp) protocol with high concentration CM (iomeprol 400 mgl/ml) in coronary CT angiography (CCTA) for patients with body mass index less than 30.
MATERIALS AND METHODS


A total of 93 patients were randomly assigned into three groups and underwent CCTA as follows: Group A) 100 kVp, 100-350 mAs, 400 mgl/ml CM at 4ml/s, and reconstructed with filtered back projection; Group B and C) 80 kVp, 100-450 mAs, 320 mgl/ml CM at 4 ml/s and 5 ml/s, respectively and reconstructed with iterative reconstruction. Objective and subjective image quality (IQ) was analyzed.
RESULTS


The image noise, intravascular attenuation, signal-to-noise ratio and contrast-to-noise ratio of major coronary arteries did not differ significantly among three groups. Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05). Qualitative IQ of Group B and C was non-inferior to that of Group A. Substantial reduction of radiation exposure was achieved in group B (2.60 ± 0.48 mSv) and C (2.72 ± 0.54 mSv), compared with group A (3.58 ± 0.67 mSv) (p < 0.05).
CONCLUSION


CCTA at 80 kVp with 320 mgl/ml CM and iterative reconstruction is feasible, achieving radiation dose reduction, while preserving IQ.",2020,"Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05).","['patients with body mass index less than 30', 'A total of 93 patients']","['low tube voltage (80 kVp) protocol with low concentration contrast media (CM) (iodixanol 320 mgl/ml) as compared with a high tube voltage (100 kVp) protocol with high concentration CM (iomeprol 400 mgl/ml) in coronary CT angiography (CCTA', 'CCTA', 'low-tube-voltage protocol with low-iodine-concentration contrast and high-tube-voltage protocol with high-iodine-concentration contrast in coronary computed tomography angiography']","['radiation exposure', 'Objective and subjective image quality (IQ', 'image noise, intravascular attenuation, signal-to-noise ratio and contrast-to-noise ratio of major coronary arteries', 'vascular attenuation and image noise']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C2350056', 'cui_str': 'iodixanol-320'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0635652', 'cui_str': 'iomeprol 400'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",93.0,0.0341413,"Subjective IQ analyses on vascular attenuation and image noise did not differ significantly, either (all of p > 0.05).","[{'ForeName': 'Min Jae', 'Initials': 'MJ', 'LastName': 'Cha', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Mok', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Ran', 'Initials': 'TR', 'LastName': 'Ahn', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yeon Hyeon', 'Initials': 'YH', 'LastName': 'Choe', 'Affiliation': 'Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0236108']
1415,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1416,32687974,Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study.,"INTRODUCTION


Latina women report disproportionately high rates of physical inactivity and related chronic health conditions. Physical activity (PA) efforts to date have shown modest success in this at-risk population; thus, more effective interventions are necessary to help Latinas reach national PA guidelines and reduce related health disparities. This paper describes the design, rationale, and baseline findings from the Seamos Activas II intervention.
METHODS/DESIGN


The ongoing RCT will test the efficacy of the Seamos Saludables PA print intervention vs. a theory-and technology-enhanced version (Seamos Activas II). The purpose of the study is to increase the percentage of Latinas meeting the national PA guidelines compared to the prior trial, improve biomarkers related to disease, and extend generalizability to a broader and more representative population of Latinas (i.e. Mexican/Mexican-Americans). Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies. The primary outcome is change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers at 6- and 12-months. Secondary PA outcomes assessed by the 7-Day PA Recall will be used to corroborate findings.
RESULTS


Participants (N = 199) are Latinas 18-65 years (mean = 43.8) of predominantly Mexican origin (89%). At baseline, objectively measured MVPA was 39.51 min/week (SD = 71.20, median = 10) and self-reported MVPA was 12.47 min/week (SD = 22.54, median = 0).Participants reported generally low self-efficacy and higher cognitive vs. behavioral processes of change.
CONCLUSION


Addressing interactivity and accountability through text messaging, and more rigorously targeting theoretical constructs may be key to helping Latinas achieve nationally recommended PA levels and thereby reducing health disparities.",2020,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","['representative population of Latinas (i.e. Mexican/Mexican-Americans', 'Latina women report disproportionately high rates of physical inactivity and related chronic health conditions', 'Participants (N\u202f=\u202f199) are Latinas 18-65\u202fyears (mean\u202f=\u202f43.8) of predominantly Mexican origin (89', 'Latinas']","['Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies', 'theory- and technology- enhanced physical activity intervention']","['low self-efficacy and higher cognitive vs. behavioral processes of change', 'change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2712043', 'cui_str': 'Lacking belief in own ability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0266557,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","[{'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America; Department of Human Development and Family Studies, University of Connecticut, Storrs, CT, United States of America.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America. Electronic address: bess_marcus@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106081']
1417,32690032,Timing-dependent effects of transcranial direct current stimulation with mirror therapy on daily function and motor control in chronic stroke: a randomized controlled pilot study.,"BACKGROUND


The timing of transcranial direct current stimulation (tDCS) with neurorehabilitation interventions may affect its modulatory effects. Motor function has been reported to be modulated by the timing of tDCS; however, whether the timing of tDCS would also affect restoration of daily function and upper extremity motor control with neurorehabilitation in stroke patients remains largely unexplored. Mirror therapy (MT) is a potentially effective neurorehabilitation approach for improving paretic arm function in stroke patients. This study aimed to determine whether the timing of tDCS with MT would influence treatment effects on daily function, motor function and motor control in individuals with chronic stroke.
METHODS


This study was a double-blinded randomized controlled trial. Twenty-eight individuals with chronic stroke received one of the following three interventions: (1) sequentially combined tDCS with MT (SEQ), (2) concurrently combined tDCS with MT (CON), and (3) sham tDCS with MT (SHAM). Participants received interventions for 90 min/day, 5 days/week for 4 weeks. Daily function was assessed using the Nottingham Extended Activities of Daily Living Scale. Upper extremity motor function was assessed using the Fugl-Meyer Assessment Scale. Upper extremity motor control was evaluated using movement kinematic assessments.
RESULTS


There were significant differences in daily function between the three groups. The SEQ group had greater improvement in daily function than the CON and SHAM groups. Kinematic analyses showed that movement time of the paretic hand significantly reduced in the SEQ group after interventions. All three groups had significant improvement in motor function from pre-intervention to post-intervention.
CONCLUSION


The timing of tDCS with MT may influence restoration of daily function and movement efficiency of the paretic hand in chronic stroke patients. Sequentially applying tDCS prior to MT seems to be advantageous for enhancing daily function and hand movement control, and may be considered as a potentially useful strategy in future clinical application.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02827864 . Registered on 29th June, 2016.",2020,Mirror therapy (MT) is a potentially effective neurorehabilitation approach for improving paretic arm function in stroke patients.,"['Twenty-eight individuals with chronic stroke', 'individuals with chronic stroke', 'stroke patients', 'chronic stroke', 'chronic stroke patients']","['combined tDCS with MT (SEQ), (2) concurrently combined tDCS with MT (CON), and (3) sham tDCS with MT (SHAM', 'SEQ', 'tDCS with MT', 'transcranial direct current stimulation (tDCS) with neurorehabilitation interventions', 'Mirror therapy (MT', 'CON', 'transcranial direct current stimulation with mirror therapy']","['daily function, motor function and motor control', 'Upper extremity motor function', 'daily function and motor control', 'daily function', 'movement time of the paretic', 'Nottingham Extended Activities of Daily Living Scale', 'motor function', 'Daily function']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",28.0,0.17181,Mirror therapy (MT) is a potentially effective neurorehabilitation approach for improving paretic arm function in stroke patients.,"[{'ForeName': 'Wan-Wen', 'Initials': 'WW', 'LastName': 'Liao', 'Affiliation': 'Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University, 259 Wen-hwa 1st Road, Taoyuan City, Taiwan.'}, {'ForeName': 'Wei-Chi', 'Initials': 'WC', 'LastName': 'Chiang', 'Affiliation': 'Department of Occupational Therapy, I-Shou University, Kaohsiung, Taiwan.'}, {'ForeName': 'Keh-Chung', 'Initials': 'KC', 'LastName': 'Lin', 'Affiliation': 'School of Occupational Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ching-Yi', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': 'Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University, 259 Wen-hwa 1st Road, Taoyuan City, Taiwan. cywu@mail.cgu.edu.tw.'}, {'ForeName': 'Chien-Ting', 'Initials': 'CT', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation, Taipei Tzu Chi Hospital, The Buddhist Tzu-Chi Medical Foundation, Taipei, Taiwan.'}, {'ForeName': 'Yu-Wei', 'Initials': 'YW', 'LastName': 'Hsieh', 'Affiliation': 'Department of Occupational Therapy and Graduate Institute of Behavioral Sciences, College of Medicine, Chang Gung University, 259 Wen-hwa 1st Road, Taoyuan City, Taiwan.'}, {'ForeName': 'Yun-Chung', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chia-Ling', 'Initials': 'CL', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital, Linkou, Taiwan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00722-1']
1418,32690591,Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE).,"BACKGROUND


Observational studies have supported the practice of offering minimally invasive interval debulking surgery after neoadjuvant chemotherapy for well-selected patients with advanced epithelial ovarian cancer. However, there are no prospective randomized data comparing the oncologic efficacy of minimally invasive and open interval debulking surgery in epithelial ovarian cancer.
PRIMARY OBJECTIVE


The primary objective of this study is to examine whether minimally invasive surgery is non-inferior to laparotomy in terms of disease-free survival in women with advanced stage epithelial ovarian cancer that responded to three or four cycles of neoadjuvant chemotherapy.
STUDY HYPOTHESIS


We hypothesize that in patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy.
TRIAL DESIGN


The Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE) trial is an international, prospective, randomized, multicenter, non-inferiority phase III trial to compare minimally invasive surgery vs laparotomy in women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125. The first 100 participants will be enrolled into a pilot lead-in to determine feasibility. The study will be considered feasible and will continue to Phase III under the following conditions: the accrual rate reaches at least 80% of the target rate after all pilot sites are open; the crossover rate in the minimally invasive group is less than 25%; and the difference of complete gross resection between the minimally invasive and open group is less than 20%. If the study is determined to be feasible, all remaining participants will be enrolled into the Phase III stage.
MAJOR INCLUSION/EXCLUSION CRITERIA


Patients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled. Patients with evidence of tumor not amenable to minimally invasive resection on pre-operative imaging will be excluded.
PRIMARY ENDPOINT


The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.
SAMPLE SIZE


To demonstrate non-inferiority with a margin of 33% in the hazard ratio (HR=1.33), 549 patients will be randomized.",2020,"The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.
","['100 participants', 'women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125', 'patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy', '549 patients will be randomized', 'women with advanced stage epithelial ovarian cancer', 'patients with advanced epithelial ovarian cancer', 'Patients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled']","['minimally invasive and open interval debulking surgery', 'Laparoscopic cytoreduction', 'Neoadjuvant ChEmotherapy (LANCE', 'minimally invasive surgery', 'minimally invasive interval debulking surgery after neoadjuvant chemotherapy', 'minimally invasive surgery vs laparotomy', 'neoadjuvant chemotherapy']",['non-inferiority of disease-free survival'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006610', 'cui_str': 'Cancer antigen 125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}]","[{'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",549.0,0.355422,"The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.
","[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nitecki', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jose Alejandro', 'Initials': 'JA', 'LastName': 'Rauh-Hain', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA jarauh@mdanderson.org.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Melamed', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': ""Department of Women's and Children's Health, Policlinico A Gemelli, Rome, Italy.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Instituto Nacional de Cancerología, Bogotá, and Clínica de Oncología Astorga, Medellin, Colombia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The US Oncology Network, The Woodlands, Texas, USA.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Fagotti', 'Affiliation': ""Department of Women's and Children's Health, Policlinico A Gemelli, Rome, Italy.""}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001584']
1419,32696178,Effect of weight-loss diet combined with taurine supplementation on body composition and some biochemical markers in obese women: a randomized clinical trial.,"Taurine (Tau), an endogenous non-protein and sulfuric-amino acid, is involved in various biological pathways including anti-inflammatory, anti-oxidation, insulin resistance inhibition, and lipid profile improvement. According to some experimental and clinical studies, insulin resistance and excess body weight are associated with reduced serum level of Tau. Therefore, this study was aimed to evaluate Tau supplementation and a diet-induced weight-loss intervention on body composition and some biochemical indices of obese women. Participants were divided randomly into the intervention (standard weight-loss group + cap Tau 3 g/day for 8 weeks, n = 20) and control (standard weight-loss group + cap placebo for 8 weeks, n = 18) groups. To achieve weight loss, all participants received an individualized diet that included a 30% reduction in their total energy intake. Chi-square test was applied to compare categorical variables between two groups at baseline. Paired t test and independent-sample t test were also used to analyze the parametric continuous data within and between the two groups, respectively. Analysis of covariance was run for controlling the confounding variables. At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group. No significant results were found in the mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes between the two groups (p > 0.05). The findings showed that Tau supplementation along with a weight-loss diet may be more effective in improving the lipid profile and metabolic risk factors compared with a weight-loss diet alone.",2020,"At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group.",['obese women'],"['Tau supplementation and a diet-induced weight-loss intervention', 'weight-loss diet combined with taurine supplementation', 'Taurine (Tau', 'intervention (standard weight-loss group\u2009+\u2009cap Tau 3 g/day for 8\xa0weeks, n\u2009=\u200920) and control (standard weight-loss group\u2009+\u2009cap placebo']","['high sensitivity C-reactive protein', 'leptin', 'low-density lipoprotein cholesterol', 'body composition', 'total adiponectin', 'weight loss', 'mean changes of high-density lipoprotein cholesterol, anthropometric measurements, glycemic indices, and liver enzymes', 'lipid profile and metabolic risk factors', 'mean changes of total cholesterol']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0281008,"At the post-intervention, the mean changes of total cholesterol (p = 0.03), low-density lipoprotein cholesterol (p = 0.03), leptin (p = 0. 006), total adiponectin (p = 0.04), and high sensitivity C-reactive protein (p = 0.03) decreased significantly in Tau group compared with the control group.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Asadi', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. maryamasadi136@gmail.com.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Mohammadi-Asl', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Amino acids,['10.1007/s00726-020-02876-7']
1420,32700926,Countering emotional behaviors in the treatment of borderline personality disorder.,"The purpose of the current study was to investigate the unique effects of a commonly used skill incorporated into treatment packages for borderline personality disorder (BPD), countering emotion-driven behavioral urges. Individuals with BPD ( N  = 8) participated in a single-case experimental design, specifically a multiple baseline, in which they were randomly assigned to complete a baseline assessment-only phase of 2 or 4 weeks. Participants then received four sessions of the countering emotional behaviors module from the unified protocol, followed by a 4-week follow-up phase. Throughout the duration of the study, daily data capture was used to assess real-time changes in the frequency of emotionally avoidant behaviors in response to emotional experiences. Symptoms of BPD, depression, and anxiety were also assessed. By follow-up, the majority of patients demonstrated a meaningful reduction (per single-case experimental design guidelines for evaluating improvements) in their use of avoidant behaviors. There was also preliminary evidence that encouraging participants to act counter to avoidant urges is associated with decreases in BPD, depression, and anxiety symptoms, as well as negative affectivity. The countering emotional behaviors skill from the unified protocol indeed engages its putative target of emotionally avoidant behavioral coping, indicating it is an active ingredient in multicomponent treatment packages for BPD, with implications for downstream clinical endpoints such as BPD and depressive and anxiety symptoms. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"There was also preliminary evidence that encouraging participants to act counter to avoidant urges is associated with decreases in BPD, depression, and anxiety symptoms, as well as negative affectivity.","['borderline personality disorder', 'Individuals with BPD ( N  = 8) participated', 'borderline personality disorder (BPD']",[],"['Countering emotional behaviors', 'Symptoms of BPD, depression, and anxiety', 'BPD, depression, and anxiety symptoms']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0317915,"There was also preliminary evidence that encouraging participants to act counter to avoidant urges is associated with decreases in BPD, depression, and anxiety symptoms, as well as negative affectivity.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Sauer-Zavala', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Clair', 'Initials': 'C', 'LastName': 'Cassiello-Robbins', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Brittany K', 'Initials': 'BK', 'LastName': 'Woods', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Curreri', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Juilanne', 'Initials': 'J', 'LastName': 'Wilner Tirpak', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Rassaby', 'Affiliation': 'Department of Psychological and Brain Sciences.'}]",Personality disorders,['10.1037/per0000379']
1421,32702259,Re: Home-Based 'Exergaming' Was Safe and Significantly Improved 6-Min Walking Distance in Patients with Prostate Cancer: A Single-Blinded Randomised Controlled Trial.,,2020,,['Patients with Prostate Cancer'],[],['6-Min Walking Distance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.10883,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.03']
1422,32702079,Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial.,"Importance


Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear.
Objective


To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF.
Design, Setting, and Participants


This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019.
Interventions


Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter.
Main Outcomes and Measures


Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process.
Results


The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes).
Conclusion and Relevance


The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF.
Trial Registration


ClinicalTrials.gov Identifier: NCT02905032.",2020,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","['Patients With Atrial Fibrillation', 'mean [SD] age, 71 [11] years) and 244 clinicians', 'patients with atrial fibrillation (AF', '922 patients (559 men [60.6', 'A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication', 'patients with AF', '463 patients were randomized to the intervention arm and 459 patients to the standard care arm', 'patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019']",['standard care arm or care that included the use of an SDM tool (intervention arm'],"['Decision Making 12-item scale) scores', 'encounter duration', 'SDM quality and clinician satisfaction', 'Measures\n\n\nQuality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",922.0,0.0691682,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","[{'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kunneman', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Branda', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Hargraves', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Sivly', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lee', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Haeshik', 'Initials': 'H', 'LastName': 'Gorr', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Burnett', 'Affiliation': 'Thrombosis Clinic and Anticoagulation Services, Park Nicollet Health Services, St Louis Park, Minnesota.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jackson', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linzer', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Brand-McCarthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2908']
1423,32710304,Early surfactant replacement guided by lung ultrasound in preterm newborns with RDS: the ULTRASURF randomised controlled trial.,"This study aimed to investigate whether using lung ultrasound (LUS) scores in premature newborns with respiratory distress syndrome (RDS) allows for earlier surfactant therapy (within the first 3 h of life) than using FiO 2  criteria. This was a randomised, non-blinded clinical trial conducted in a neonatal intensive care unit. The inclusion criteria were newborns with a gestational age of ≤ 32 weeks and RDS. Patients meeting the inclusion criteria were randomly assigned to two groups: the ultrasound group, administered surfactant based on LUS score and/or FiO 2  threshold, and the control group, guided by FiO 2  only. Fifty-six patients were included. The ultrasound group received surfactant earlier (1 h of life vs. 6 h, p < 0.001), with lower FiO 2  (25% vs. 30%, p = 0.016) and lower CO 2  (48 vs. 54, p = 0.011). After surfactant treatment, newborns in the ultrasound group presented a greater SpO 2  (p = 0.001) and SpO 2 /FiO 2  ratio (p = 0.012).Conclusions: LUS score allowed an earlier surfactant therapy, reduced oxygen exposure early in life and a better oxygenation after the treatment. This early surfactant replacement may lead to reduced oxygen exposure. What is Known: • Lung ultrasound scores predict the need for surfactant therapy in premature newborns. What is New: • This study shows that using lung ultrasound scores improves the timeliness of surfactant replacement compared with using FiO 2 alone.",2020,"The ultrasound group received surfactant earlier (1 h of life vs. 6 h, p < 0.001), with lower FiO 2  (25% vs. 30%, p = 0.016) and lower CO 2  (48 vs. 54, p = 0.011).","['premature newborns', 'preterm newborns with RDS', 'Patients meeting the inclusion criteria', 'newborns with a gestational age of ≤ 32 weeks and RDS', 'premature newborns with respiratory distress syndrome (RDS', 'Fifty-six patients were included']","['surfactant replacement guided by lung ultrasound', 'surfactant therapy', 'lung ultrasound (LUS) scores', 'ultrasound group, administered surfactant based on LUS score and/or FiO 2  threshold, and the control group, guided by FiO 2  only']",['oxygen exposure early in life and a better oxygenation'],"[{'cui': 'C0233315', 'cui_str': 'Premature birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",56.0,0.110221,"The ultrasound group received surfactant earlier (1 h of life vs. 6 h, p < 0.001), with lower FiO 2  (25% vs. 30%, p = 0.016) and lower CO 2  (48 vs. 54, p = 0.011).","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodriguez-Fanjul', 'Affiliation': 'Neonatal Intensive Care Unit, Paediatrics Department, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain. javier.rodriguez.fanjul@gmail.com.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Jordan', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balaguer', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Batista-Muñoz', 'Affiliation': 'Neonatal Intensive Care Unit, Paediatrics Department, Hospital Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramon', 'Affiliation': 'Neonatal Intensive Care Unit, Paediatrics Department, Hospital Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bobillo-Perez', 'Affiliation': 'Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain.'}]",European journal of pediatrics,['10.1007/s00431-020-03744-y']
1424,32706883,IL-6 Response to Psychosocial Stress Predicts 12-month Changes in Cardiometabolic Biomarkers in Perimenopausal Women.,"OBJECTIVE


Cardiometabolic diseases are the number one cause of mortality, accounting for over one third of all deaths in the United States. Cardiometabolic risk further increases with psychosocial stress exposure and during menopausal transition in women. Because disease risk and stress burden are associated with aberrant immune signaling, we hypothesized that responses of interleukin-6 (IL-6) to psychosocial stress may predict longitudinal cardiometabolic outcomes in perimenopausal women.
METHODS


We conducted post hoc analyses in 151 perimenopausal or early postmenopausal women participants in a previously completed study. At study onset, participants underwent the Trier Social Stress Test (TSST), and plasma IL-6 was measured repeatedly before and during the 1 hour post-TSST. Subsequently, participants were randomly assigned to either hormonal treatment (HT) or placebo and followed for 12 months to determine longitudinal changes in cardiometabolic biomarkers.
RESULTS


Greater IL-6 reactivity to stress, measured with baseline-adjusted area under the curve, predicted 12-month decrease in flow-mediated dilatation of the brachial artery (P = 0.0005), a measure of endothelial-dependent vascular function, but not in endothelial-independent function measured with nitroglycerin-mediated dilatation (P = 0.17). Greater baseline IL-6 levels predicted 12-month increase in insulin resistance based on the homeostatic model assessment of insulin resistance score (P = 0.0045) and in the number of criteria met for metabolic syndrome (P = 0.0008). These predictions were not moderated by HT.
CONCLUSIONS


Greater baseline IL-6 levels as well as its reactivity to stress may predict worsening in distinct cardiometabolic biomarkers as women transition to menopause. Interleukin-6 reactivity predicts decline in endothelial-dependent vascular function, whereas baseline IL-6 presages accumulation of metabolic risk.",2020,Greater baseline IL-6 levels predicted 12-month increase in insulin resistance based on the HOMA-IR score (p=0.0045) and in the number of criteria met for metabolic syndrome (p=0.0008).,"['perimenopausal women', 'Perimenopausal Women', '151 perimenopausal or early postmenopausal women participants in a previously completed study', 'women']","['hormonal treatment (HT) or placebo', 'IL-6']","['IL-6 reactivity to stress', 'flow-mediated dilatation of the brachial artery', 'Trier Social Stress Test (TSST), and plasma IL-6', 'HOMA-IR score', 'Greater baseline IL-6 levels', 'endothelial-dependent vascular function']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.148833,Greater baseline IL-6 levels predicted 12-month increase in insulin resistance based on the HOMA-IR score (p=0.0045) and in the number of criteria met for metabolic syndrome (p=0.0008).,"[{'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Zannas', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, University of Regina, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Girdler', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa476']
1425,32679405,A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.,"PURPOSE


Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA.
PATIENTS AND METHODS


E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections.
RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients.
CONCLUSIONS


We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.",2020,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","['120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers', 'oropharyngeal cancer (OPC']","['surgeon expertise and surgical quality assurance (QA', 'transoral surgery', 'transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC']","['positive final pathologic margins', 'positive margins, low oropharyngeal bleeding rates', 'Grade III/IV and grade V oropharyngeal bleeding']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0010298', 'cui_str': 'Credentialing'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",120.0,0.0606723,"RESULTS


120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers.","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States. Electronic address: Ferrisrl@upmc.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Flamand', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'F Christopher', 'Initials': 'FC', 'LastName': 'Holsinger', 'Affiliation': 'Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Weinstein', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joaquin J', 'Initials': 'JJ', 'LastName': 'Garcia', 'Affiliation': 'Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Hinni', 'Affiliation': 'Mayo Clinic in Arizona, Phoenix, AZ, United States.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Erich M', 'Initials': 'EM', 'LastName': 'Sturgis', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'Umamaheswar', 'Initials': 'U', 'LastName': 'Duvvuri', 'Affiliation': 'UPMC Hillman Cancer Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Méndez', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ridge', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Magnuson', 'Affiliation': 'Florida Hospital Orlando, Celebration, FL, United States.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Higgins', 'Affiliation': 'ECOG-ACRIN Cancer Research Group, Boston, MA, United States.'}, {'ForeName': 'Mihir R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Russel B', 'Initials': 'RB', 'LastName': 'Smith', 'Affiliation': 'University of Nebraska, Omaha, NE, United States.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Karakla', 'Affiliation': 'Sentara Norfolk General Hospital, Norfolk, VA, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Kupferman', 'Affiliation': 'The University of Texas, M.D. Anderson Cancer Center, Houston, TX, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Malone', 'Affiliation': 'UPMC Pinnacle Cancer Center, Harrisburg, PA, United States.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Judson', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Richmon', 'Affiliation': 'Massachusetts Eye and Ear, Harvard University, Boston, MA, United States.'}, {'ForeName': 'Jay O', 'Initials': 'JO', 'LastName': 'Boyle', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, United States.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Bayon', 'Affiliation': 'University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Bert W', 'Initials': 'BW', 'LastName': ""O'Malley"", 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Enver', 'Initials': 'E', 'LastName': 'Ozer', 'Affiliation': 'The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Giovana R', 'Initials': 'GR', 'LastName': 'Thomas', 'Affiliation': 'University of Miami Leonard Miller School of Medicine, Miami, FL, United States.'}, {'ForeName': 'Wayne M', 'Initials': 'WM', 'LastName': 'Koch', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'R Bryan', 'Initials': 'RB', 'LastName': 'Bell', 'Affiliation': 'Providence Cancer Institute, Portland, OR, United States.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute at Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute-ECOG-ACRIN Biostatistics Center, Boston, MA, United States.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale School of Medicine and Yale Cancer Center, New Haven, CT, United States.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104797']
1426,32680630,"Corrigendum to 'Unmet Needs of US Acute Stroke Survivors Enrolled in a Transitional Care Intervention Trial' [Journal of Stroke and Cerebrovascular Diseases, Vol. 29, No. 2 (February), 2020: 104462].",,2020,,[],[],[],[],[],[],,0.0411084,,"[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Hughes', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI. Electronic address: hughesa@msu.edu.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Woodward', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI.'}, {'ForeName': 'Michele C', 'Initials': 'MC', 'LastName': 'Fritz', 'Affiliation': 'Michigan State University, Department of Epidemiology and Biostatistics, East Lansing, MI.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Swierenga', 'Affiliation': 'Michigan State University, Outreach and Engagement, East Lansing, MI.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Freddolino', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Reeves', 'Affiliation': 'Michigan State University, Department of Epidemiology and Biostatistics, East Lansing, MI.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105044']
1427,32681460,Reduced Hypoglycemia Risk in Type 2 Diabetes Patients Switched to/Initiating Insulin Glargine 300 vs 100 U/ml: A European Real-World Study.,"INTRODUCTION


Randomized controlled trials and real-world data from the USA have shown similar glycemic control with insulin glargine 300 U/ml (Gla-300) and insulin glargine 100 U/ml (Gla-100) and reduced hypoglycemia risk with Gla-300. This real-world study describes the efficacy and safety of Gla-300 and Gla-100 in patients with type 2 diabetes (T2D) in France, Spain, and Germany.
METHODS


This retrospective chart review analysis used anonymized data for adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100. Outcomes included change from baseline to 6-month follow-up in glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice.
RESULTS


Six hundred sixty-five physicians (33.8% Spain, 31.7% France, 34.4% Germany) provided chart data for patients switching to Gla-300 (n = 679) or Gla-100 (n = 429) or initiating Gla-300 (n = 719) or Gla-100 (n = 711). After adjustment for baseline characteristics, A1C reductions from baseline were similar for patients switching to Gla-300 or Gla-100 (- 0.87% vs. - 0.93%; p = 0.326) while those switched to Gla-300 vs. Gla-100 had a significantly greater mean reduction in hypoglycemic events (- 1.29 vs. - 0.81 events during 6 months; p = 0.012). Mean insulin doses after titration were 0.43 ± 0.36 and 0.40 ± 0.28 U/kg in Gla-300 and Gla-100 switchers, respectively. Factors that significantly influenced BIA choice included a lower risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100). Outcomes for insulin-naïve patients were broadly similar to those of switchers.
CONCLUSIONS


In this real-world European study, patients with T2D who switched therapy to Gla-300 or Gla-100 had improved glycemic control and reduced hypoglycemia at 6 months, with significant hypoglycemia advantages with Gla-300.",2020,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","['Six hundred sixty-five physicians', '300 vs 100 U', 'adults with T2D switching basal insulin analog (BIA) therapy to Gla-300 or Gla-100, or insulin-naïve patients initiating Gla-300 or Gla-100', 'patients with type 2 diabetes (T2D) in France, Spain, and Germany']","['Gla-300 and Gla-100', 'Insulin Glargine']","['glycated hemoglobin A1c (A1C), total and severe hypoglycemia incidences and events, insulin dose, and reasons for BIA choice', 'risk of hypoglycemia (for Gla-300) and physician familiarity (for Gla-100', 'Hypoglycemia Risk', 'Mean insulin doses', 'glycemic control and reduced hypoglycemia', 'hypoglycemic events', 'hypoglycemia risk']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}]",,0.0204853,"Outcomes for insulin-naïve patients were broadly similar to those of switchers.
","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escalada', 'Affiliation': 'Clinic University of Navarra, Pamplona, Spain. fjavier.escalada@gmail.com.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bonnet', 'Affiliation': 'CHU de Rennes, Université Rennes 1, Rennes, France.'}, {'ForeName': 'Jasmanda', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Shaloo', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Janelle M', 'Initials': 'JM', 'LastName': 'Cambron-Mellott', 'Affiliation': 'Kantar, New York, NY, USA.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Nicholls', 'Affiliation': 'Sanofi, Reading, UK.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Medicine, University Hospital Aachen, Aachen, Germany.'}]",Advances in therapy,['10.1007/s12325-020-01436-5']
1428,32689826,Prospective Evaluation of Bilateral Retrograde Intrarenal Surgery: Is It Really Safe?,"Introduction:  The aim of this study was to prospectively compare the outcomes of bilateral same-session retrograde intrarenal surgery (BSS RIRS) with unilateral RIRS and to compare the outcomes of first with second operated kidneys in BSS RIRS.  Subjects and Methods:  Consecutive symptomatic adult patients with kidney stones up to 20 mm who accepted to be treated by RIRS were prospectively studied. Stone-free rate (SFR) was evaluated by non-contrast CT for each renal unit, and surgical complications were evaluated based on Clavien-Dindo classification.  Results:  SFR (73.9%  vs  76.1%,  p  = 0.830) and hospitalization time (14.43 ± 18.81 hours  vs  13.00 ± 4.89 hours,  p  = 0.564) were similar between unilateral and BSS RIRS groups, with less consumption of disposable devices in BSS RIRS ( p  = 0.017). Operative time was longer in BSS RIRS (61.24 ± 26.62 minutes  vs  88.65 ± 33.19 minutes,  p  < 0.001). Bilateral group had significant more overall complications by Clavien-Dindo classification than unilateral (15.9%  vs  39.9%,  p  = 0.030) and more emergency room (ER) visits (11.6%  vs  34.8%,  p  = 0.026). Moreover, although both groups temporarily increased creatinine levels, it was significantly higher in bilateral RIRS ( p  = 0.019). First operated kidney outcomes were similar to second operated kidney outcomes of BSS RIRS.  Conclusion  Although BSS RIRS had similar SFR and consumed less disposable devices, it had a higher overall complication rate, a higher frequency of ER visits, and higher creatinine levels during follow-up than unilateral RIRS. There is no significant outcome difference between first and second operated kidneys in BSS RIRS.",2020,"Results SFR (73.9% vs. 76.1%, p=0.830) and hospitalization time (14.43 ± 18.81 h vs. 13.00 ± 4.89 h, p=0.564) were similar between unilateral and BSS RIRS groups with less consumption of disposable devices in BSS RIRS (p=0.017).",['Methods Consecutive symptomatic adult patients with kidney stones up to 20 mm that accepted to be treated by RIRS were prospectively studied'],"['bilateral same session retrograde intrarenal surgery (BSS RIRS', 'Bilateral Retrograde Intrarenal Surgery']","['Stone-free rate (SFR', 'overall complications', 'Operative time', 'hospitalization time', 'overall complication rate, higher frequency of emergency room visits and higher creatinine levels', 'emergency room visits', 'creatinine levels', 'bilateral RIRS']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0151578', 'cui_str': 'Creatinine increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",,0.0533197,"Results SFR (73.9% vs. 76.1%, p=0.830) and hospitalization time (14.43 ± 18.81 h vs. 13.00 ± 4.89 h, p=0.564) were similar between unilateral and BSS RIRS groups with less consumption of disposable devices in BSS RIRS (p=0.017).","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Danilovic', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Fabio Cesar Miranda', 'Initials': 'FCM', 'LastName': 'Torricelli', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Giovanni Scala', 'Initials': 'GS', 'LastName': 'Marchini', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Batagello', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Fabio Carvalho', 'Initials': 'FC', 'LastName': 'Vicentini', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Traxer', 'Affiliation': 'Department of Urology, Sorbonne Université, GRC n20 Lithiase Renale, AP-HP, Hôpital Tenon, Paris, France.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mazzucchi', 'Affiliation': 'Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",Journal of endourology,['10.1089/end.2020.0611']
1429,32690739,Study protocol for the POPART study-Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial.,"INTRODUCTION


Many preterm infants develop respiratory distress syndrome (RDS), a condition characterised by a relative lack of surfactant. Endotracheal surfactant therapy revolutionised the care of preterm infants in the 1990s. However, supporting newborns with RDS with continuous positive airway pressure (CPAP) and reserving endotracheal surfactant for those who develop respiratory failure despite CPAP yield better results than intubating all infants for surfactant. Half of preterm infants born before 29 weeks gestation initially managed with CPAP are intubated for surfactant. Intubation is difficult to learn and associated with adverse effects. Surfactant administration into the oropharynx has been reported in preterm animals and humans and may be effective. We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.
METHODS AND ANALYSIS


Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial (POPART, Eudract No. 2016-004198-41) is an investigator-led, unblinded, multicentre, randomised, parallel group, controlled trial. Infants are eligible if born at a participating centre before 29 weeks gestational age (GA) and there is a plan to offer intensive care. Infants are excluded if they have major congenital anomalies. Infants are randomised at birth to treatment with oropharyngeal surfactant (120 mg vial <26 weeks GA stratum; 240 mg vial 26-28 +6  weeks GA stratum) in addition to CPAP or CPAP alone. The primary outcome is intubation within 120 hours of birth, for bradycardia and/or apnoea despite respiratory support in the delivery room or respiratory failure in the intensive care unit. Secondary outcomes include incidence of mechanical ventilation, endotracheal surfactant use, chronic lung disease and death before hospital discharge.
ETHICS AND DISSEMINATION


Approval for the study has been granted by the Research Ethics Committees at the National Maternity Hospital, Dublin, Ireland (EC31.2016) and at each participating site. The trial is being conducted at nine centres in six European countries. The study results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


2016-004198-41; Pre-results.",2020,"We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.
","['Many preterm infants develop respiratory distress syndrome (RDS', 'newborns with RDS with continuous positive airway pressure (CPAP', 'Infants are eligible if born at a participating centre before 29 weeks gestational age (GA) and there is a plan to offer intensive care', 'nine centres in six European countries', 'preterm infants in the 1990s', 'Preterm infants', 'preterm infants born before 29 weeks gestation initially managed with', 'preterm infants within 120\u2009hours of birth']","['Endotracheal surfactant therapy', 'oropharyngeal surfactant', 'CPAP', 'Prophylactic Oropharyngeal surfactant', 'CPAP or CPAP alone']","['intubation within 120\u2009hours of birth, for bradycardia and/or apnoea despite respiratory support in the delivery room or respiratory failure in the intensive care unit', 'incidence of mechanical ventilation, endotracheal surfactant use, chronic lung disease and death before hospital discharge']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",,0.44978,"We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.
","[{'ForeName': 'Madeleine Claire', 'Initials': 'MC', 'LastName': 'Murphy', 'Affiliation': 'Department of Neonatology, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Galligan', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Molloy', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'UCD Clinical Research Centre, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Neonatology, National Maternity Hospital, Dublin, Ireland codonnell@nmh.ie.'}]",BMJ open,['10.1136/bmjopen-2019-035994']
1430,32696600,The detrimental effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.,"AIMS


A reduction of habitual physical activity due to prolonged COVID-19 quarantine can have serious consequences for patients with cardiovascular diseases, such as heart failure. This study aimed to explore the effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.
METHODS AND RESULTS


We analysed the daily number of steps in 26 heart failure patients during a 6-week period that included 3 weeks immediately preceding the onset of the quarantine and the first 3 weeks of the quarantine. The daily number of steps was assessed using a wrist-worn accelerometer worn by the patients as part of an ongoing randomized controlled trial. Multilevel modelling was used to explore the effect of the quarantine on the daily step count adjusted for weather conditions. As compared with the 3 weeks before the onset of the quarantine, the step count was significantly lower during each of the first 3 weeks of the quarantine (P < 0.05). When the daily step count was averaged across the 3 weeks before and during the quarantine, the decrease amounted to 1134 (SE 189) steps per day (P < 0.001), which translated to a 16.2% decrease.
CONCLUSIONS


The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period. Staying active and maintaining sufficient levels of physical activity during the COVID-19 pandemic are essential despite the unfavourable circumstances of quarantine.",2020,"The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period.","['heart failure patients', 'patients with cardiovascular diseases, such as heart failure', '26 heart failure patients']",['COVID-19 nationwide quarantine'],['habitual physical activity'],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0034386', 'cui_str': 'Quarantine'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0344114,"The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Vetrovsky', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Tereza', 'Initials': 'T', 'LastName': 'Frybova', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Iulian', 'Initials': 'I', 'LastName': 'Gant', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Semerad', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cimler', 'Affiliation': 'Faculty of Science, University of Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Vaclav', 'Initials': 'V', 'LastName': 'Bunc', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, José Martího 269/31, Prague, 162 52, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Siranec', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Miklikova', 'Affiliation': 'Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Vesely', 'Affiliation': 'Faculty of Medicine in Hradec Králové, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Griva', 'Affiliation': 'Department of Cardiology, Tomas Bata Regional Hospital in Zlin, Zlin, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Precek', 'Affiliation': 'Department of Internal Medicine I-Cardiology, University Hospital Olomouc, Olomouc, Czech Republic.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Pelouch', 'Affiliation': '1st Department of Internal Medicine-Cardioangiology, University Hospital Hradec Králové, Hradec Králové, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Parenica', 'Affiliation': 'Cardiology Department, University Hospital Brno and Medical Faculty of the Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': '2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.'}]",ESC heart failure,['10.1002/ehf2.12916']
1431,32693197,"Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve.","Vitamin K antagonists are the only approved oral anticoagulants for long-term prophylaxis against valve thrombosis and thromboembolism in patients with a mechanical heart valve. Despite the proven efficacy and safety of anticoagulation with the oral direct factor Xa inhibitor apixaban compared with warfarin in high-risk populations including subjects with atrial fibrillation or with venous thromboembolism, it remains unknown whether patients with a mechanical heart valve can be safely managed with apixaban. The On-X Aortic Heart Valve and On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft may have lower rates of valve thrombosis and thromboembolism than conventional bileaflet and tilting disc valves due its unique pyrolytic carbon composition and flared inlet design. DESIGN: PROACT Xa is a randomized, multicenter, open-label, active-controlled trial comparing apixaban with warfarin in patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft. The study will randomize approximately 1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3 months prior. Patients will be randomized 1:1 to receiving apixaban 5 mg twice daily or warfarin with a target international normalized ratio of 2.0-3.0. The last randomized participant will be followed for at least 2 years. The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding. Assuming the primary outcome occurs in warfarin-anticoagulated patients at a rate of 1.75%/patient-year, the study has more than 90% power to assess noninferiority of apixaban treatment with an absolute noninferiority margin of 1.75%/patient-year. A second co-primary analysis is to compare the hazard rate for the apixaban arm to twice the objective performance criterion for thromboembolism and valve thrombosis, that is, 3.4%/patient-year. SUMMARY: PROACT Xa will determine whether patients with an On-X Aortic Heart Valve can be anticoagulated with apixaban as an alternative to warfarin.",2020,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","['patients with an On-X Aortic Heart Valve or On-X Ascending Aortic Prosthesis with the Vascutek Gelweave Valsalva Graft', 'subjects with atrial fibrillation or with venous thromboembolism', '1,000 patients from approximately 60 sites in North America who underwent aortic valve replacement at least 3\u202fmonths prior', 'patients with a mechanical heart valve', 'patients with a mechanical On-X Aortic Heart Valve']","['PROACT Xa', 'apixaban 5\u202fmg twice daily or warfarin', 'apixaban versus warfarin', 'apixaban', 'warfarin', 'Vitamin K antagonists', 'apixaban with warfarin']","['efficacy and safety', 'composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding', 'hazard rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018829', 'cui_str': 'Prosthetic heart'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C3530472', 'cui_str': 'apixaban 5 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0697264,"The primary efficacy outcome is the composite of valve thrombosis and valve-related thromboembolism, and the primary safety outcome is major bleeding.","[{'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Department of Surgery, Duke University Medical Center, Durham, NC. Electronic address: oliver.jawitz@duke.edu.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Brittanny', 'Initials': 'B', 'LastName': 'Boyer', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Diseases, University of Cincinnati Heart, Lung & Vascular Institute, Cincinnati, OH.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Blackstone', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruel', 'Affiliation': 'Division of Cardiac Surgery, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Department of Cardiovascular Surgery, Mount Sinai St. Luke's, New York, NY.""}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Gerdisch', 'Affiliation': 'Department of Cardiothoracic Surgery, Franciscan Hospital, Indianapolis, IN.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Johnston', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Capps', 'Affiliation': 'CryoLife, Inc., Kennesaw, GA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Lars G', 'Initials': 'LG', 'LastName': 'Svensson', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH.'}]",American heart journal,['10.1016/j.ahj.2020.06.014']
1432,32693833,Wound closure in epidermolysis bullosa: data from the vehicle arm of the phase 3 ESSENCE Study.,"BACKGROUND


Chronic wounds are a fundamental issue for patients with epidermolysis bullosa (EB). Herein, we assess the natural history of wound closure in patients with EB who were randomly assigned to the vehicle-control arm of the multicenter, randomized, double-blind, phase 3 ESSENCE (NCT02384460) trial.
METHODS


ESSENCE was designed to assess the efficacy and safety of a topical cream formulation of 6% allantoin (SD-101 6%) vs vehicle (SD-101 0%) in patients ≥1 month old who had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50 cm 2  present for ≥21 days. Time to complete target wound closure and the proportion of patients with target wound closure over time were analyzed overall and by parameters including patient age and baseline body surface area index (BSAi) of total wound burden (< 5% and ≥ 5%). Changes in BSAi of lesional skin, pain, and itching were also assessed.
RESULTS


The vehicle-control arm included 87 patients. Mean (standard deviation [SD]) time to target wound closure within 3 months was 53.6 (28.6) days, with a range of 14 to 142 days. The proportion of patients with target wound closure increased over time from 7.1% at day 14 to 53.6% at month 3. Mean (SD) changes from baseline in BSAi of total wound burden and BSAi of lesional skin at month 3 were -2.3% (6.3) and -5.0% (13.5) of total body coverage, respectively. Reductions in pain and itching were observed at day 7 and maintained for 3 months. Faster healing times and a greater proportion of patients with wound closure were observed in patients aged 1 month to < 2 years; those with wounds < 30 days old, and in those with BSAi of total body wound burden < 5%.
CONCLUSIONS


Treatment response observed in the vehicle-control arm of the ESSENCE study was unexpectedly high and may have been due to unforeseen benefits of vehicle or enhanced wound care provided by the clinical trial staff. These observations will help inform the study design of future trials in patients with EB.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT02384460 ; Date of registration: February 13, 2015; First participant enrollment: March 11, 2015.",2020,"Faster healing times and a greater proportion of patients with wound closure were observed in patients aged 1 month to < 2 years; those with wounds < 30 days old, and in those with BSAi of total body wound burden < 5%.
","['patients with epidermolysis bullosa (EB', 'patients ≥1\u2009month old who had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10-50\u2009cm 2  present for ≥21\u2009days', 'patients with EB', '87 patients']",['topical cream formulation of 6% allantoin (SD-101 6%) vs vehicle (SD-101 0'],"['pain and itching', 'proportion of patients with wound closure', 'patient age and baseline body surface area index (BSAi) of total wound burden', 'natural history of wound closure', 'Mean (standard deviation [SD]) time to target wound closure', 'BSAi of lesional skin, pain, and itching', 'efficacy and safety', 'proportion of patients with target wound closure', 'Mean (SD) changes from baseline in BSAi of total wound burden and BSAi of lesional skin', 'Faster healing times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014527', 'cui_str': 'Epidermolysis bullosa'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0228492', 'cui_str': 'Structure of posterior semilunar lobule'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",,0.297534,"Faster healing times and a greater proportion of patients with wound closure were observed in patients aged 1 month to < 2 years; those with wounds < 30 days old, and in those with BSAi of total body wound burden < 5%.
","[{'ForeName': 'Dedee F', 'Initials': 'DF', 'LastName': 'Murrell', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Departments of Dermatology and Pediatric Dermatology, Northwestern University Feinberg School of Medicine, 676 N. St. Clair, Suite 1600, Chicago, IL, 60611-2997, USA. apaller@northwestern.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Bodemer', 'Affiliation': 'EB Expert Centre (MAGEC), Department of Dermatology, Necker-Enfants Malades Hospital, Paris Centre University, Paris, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browning', 'Affiliation': 'Texas Dermatology & Laser Specialists, San Antonio, TX, USA.'}, {'ForeName': 'Milos', 'Initials': 'M', 'LastName': 'Nikolic', 'Affiliation': 'Clinical Center of Serbia, Department of Dermatology, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Barth', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': 'Hjalmar', 'Initials': 'H', 'LastName': 'Lagast', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krusinska', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Reha', 'Affiliation': 'Amicus Therapeutics, Inc., Cranbury, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01435-3']
1433,32697909,Improved Fast Randomized Iteration Approach to Full Configuration Interaction.,"We present three modifications to our recently introduced fast randomized iteration method for full configuration interaction (FCI-FRI) and investigate their effects on the method's performance for Ne, H 2 O, and N 2 . The initiator approximation, originally developed for full configuration interaction quantum Monte Carlo, significantly reduces statistical error in FCI-FRI when few samples are used in compression operations, enabling its application to larger chemical systems. The semistochastic extension, which involves exactly preserving a fixed subset of elements in each compression, improves statistical efficiency in some cases but reduces it in others. We also developed a new approach to sampling excitations that yields consistent improvements in statistical efficiency and reductions in computational cost. We discuss possible strategies based on our findings for improving the performance of stochastic quantum chemistry methods more generally.",2020,"The initiator approximation, originally developed for full configuration interaction quantum Monte Carlo, significantly reduces statistical error in FCI-FRI when few samples are used in compression operations, enabling its application to larger chemical systems.",[],[],[],[],[],[],,0.0381083,"The initiator approximation, originally developed for full configuration interaction quantum Monte Carlo, significantly reduces statistical error in FCI-FRI when few samples are used in compression operations, enabling its application to larger chemical systems.","[{'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Greene', 'Affiliation': 'Department of Chemistry, Columbia University, New York, New York 10027, United States.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Webber', 'Affiliation': 'Courant Institute of Mathematical Sciences, New York University, New York, New York 10012, United States.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weare', 'Affiliation': 'Courant Institute of Mathematical Sciences, New York University, New York, New York 10012, United States.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Berkelbach', 'Affiliation': 'Department of Chemistry, Columbia University, New York, New York 10027, United States.'}]",Journal of chemical theory and computation,['10.1021/acs.jctc.0c00437']
1434,32701984,Acupuncture in persons with an increased stress level-Results from a randomized-controlled pilot trial.,"BACKGROUND


In today's Western societies a high percentage of people experience increased or chronic stress. Acupuncture could serve as treatment for persons affected adversely by the increased stress.
METHODS


The AkuRest study was a two-centre randomized controlled pilot study in adult persons with increased stress levels. Participants were randomly allocated to one of three groups: verum acupuncture treatment, sham acupuncture, and a waiting control group. The feasibility of the study was assessed. In addition, effects on stress level (measured by the Perceived Stress Questionnaire (PSQ-20)) and other variables were assessed at the end of treatment and a 3-month follow-up.
RESULTS


Altogether, N = 70 persons were included in the study. At the end of the treatment 15.7% were lost to follow-up. The adherence to the protocol was good: 82.9% of the participants completed 100% of their treatment. The stress level of the participants was high at baseline (mean PSQ-20 score 75.5, SD = 8.2). Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) = -1.39, 95%-CI = [-2.11; -0.67]: ES (sham) = -1.12, CI = [-1.78;-0.44]). At follow-up, effect sizes were in favour of the verum group (as compared to sham). However, confidence intervals and t-tests showed that these differences were not significant.
CONCLUSION


The pilot study demonstrated the feasibility of the acupuncture RCT in persons with increased stress levels. Estimated parameters can be used to design a larger RCT to prove the-here indicated-efficacy of verum acupuncture to decrease stress.
TRIAL REGISTRATION NUMBER


ISRCTN15259166.",2020,Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) =,"['persons with increased stress levels', 'persons with an increased stress level', 'Altogether, N = 70 persons were included in the study', 'adult persons with increased stress levels']","['acupuncture RCT', 'verum and sham acupuncture', 'Acupuncture', 'verum acupuncture', 'verum acupuncture treatment, sham acupuncture, and a waiting control group']","['Perceived Stress Questionnaire (PSQ-20', 'stress level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",70.0,0.0786007,Effect sizes (ES) at T1 showed that verum and sham acupuncture were superior to the waiting condition in reducing stress (ES (verum) =,"[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Wild', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Brenner', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Joos', 'Affiliation': 'Institute for General Practice and Interprofessional Care, Medical University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Samstag', 'Affiliation': 'Institute of Immunology, Section Molecular Immunology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Buckert', 'Affiliation': 'Department of General Internal Medicine and Psychosomatics, Medical University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Valentini', 'Affiliation': 'Institute for General Practice and Interprofessional Care, Medical University Hospital Tübingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0236004']
1435,32709912,Exercise as a protective mechanism against the negative effects of oxidative stress in first-episode psychosis: a biomarker-led study.,"First-episode psychosis (FEP) is a psychiatric disorder, characterised by positive and negative symptoms, usually emerging during adolescence and early adulthood. FEP represents an early intervention opportunity for intervention in psychosis. Redox disturbance and subsequent oxidative stress have been linked to the pathophysiology of FEP. Exercise training can perturb oxidative stress and rebalance the antioxidant system and thus represents an intervention with the potential to interact with a mechanism of disease. The aim of this study was to assess the effect of exercise on markers of redox status in FEP. Twenty-two young men were recruited from Birmingham Early Intervention services and randomised to either a 12-week exercise programme or treatment as usual (control). Measures of blood and brain glutathione (GSH), markers of oxidative damage, inflammation, neuronal health, symptomology and habitual physical activity were assessed. Exercise training was protective against changes related to continued psychosis. Symptomatically, those in the exercise group showed reductions in positive and general psychopathology, and stable negative symptoms (compared to increased negative symptoms in the control group). Peripheral GSH was increased by 5.6% in the exercise group, compared to a significant decrease (24.4%) (p = 0.04) in the control group. Exercise attenuated negative changes in markers of neuronal function (brain-derived neurotrophic factor), lipid damage (thiobarbituric acid-reactive substances) and total antioxidant capacity. C-reactive protein and tumour necrosis factor-α also decreased in the exercise group, although protein and DNA oxidation were unchanged. Moderate-intensity exercise training has the ability to elicit changes in markers of oxidative stress and antioxidant concentration, with subsequent improvements in symptoms of psychosis.",2020,"C-reactive protein and tumour necrosis factor-α also decreased in the exercise group, although protein and DNA oxidation were unchanged.","['Twenty-two young men', 'first-episode psychosis']","['Exercise training', 'Moderate-intensity exercise training', 'FEP', 'exercise programme or treatment as usual (control']","['Peripheral GSH', 'protein and DNA oxidation', 'blood and brain glutathione (GSH), markers of oxidative damage, inflammation, neuronal health, symptomology and habitual physical activity', 'positive and general psychopathology, and stable negative symptoms', 'C-reactive protein and tumour necrosis factor-α', 'neuronal function (brain-derived neurotrophic factor), lipid damage (thiobarbituric acid-reactive substances) and total antioxidant capacity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]",22.0,0.0277852,"C-reactive protein and tumour necrosis factor-α also decreased in the exercise group, although protein and DNA oxidation were unchanged.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fisher', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Wood', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Elsworthy', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Upthegrove', 'Affiliation': 'Institute for Mental Health, University of Birmingham, Edgbaston, B15 2TT, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Aldred', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, B15 2TT, UK. s.aldred.1@bham.ac.uk.'}]",Translational psychiatry,['10.1038/s41398-020-00927-x']
1436,32706996,Changes in the Health-Related Quality of Life and Weight Status of Children with Overweight or Obesity Aged 7 to 13 Years after Participating in a 10-Week Lifestyle Intervention.,"Background:  The aim of the study was to assess changes in the health-related quality of life (HRQOL) and weight status of children with overweight and obesity after participating in a 10-week family-based combined lifestyle group intervention in their community.  Methods:  In total, 340 children with overweight or obesity aged between 7 and 13 years, as well as one of their primary caregivers, took part in this intervention, in a real-world setting. The intervention comprised 20 group sessions for a 10-week period, and focused on improving knowledge, attitudes, social support, and self-efficacy in regard to healthy lifestyles. The Pediatric Quality of Life Inventory 4.0 (PedsQL) and Impact of Weight on Quality of Life-Kids (IWQOL-KIDS) questionnaires were used to determine generic and weight-specific HRQOL. Changes in HRQOL and BMI (standard deviation [SDS] of BMI, objectively measured) were tested using a Wilcoxon signed-rank test, Mann-Whitney U test, and paired  t -test.  Results:  Generic quality of life ( Z  = -3.58,  r  = -0.25), weight-specific quality of life ( Z  = -4.83,  r  = -0.34), and SDS-BMI ( d  = 0.21) were all significantly improved after participating in the 10-week intervention. The mean attendance rate was 73.74%.  Conclusion:  This study demonstrated that participation in the intervention LEFF for children with overweight and obesity was associated with improved generic and weight-specific HRQOL and SDS-BMI.",2020,"Results:  Generic quality of life ( Z  = -3.58,  r  = -0.25), weight-specific quality of life ( Z  = -4.83,  r  = -0.34), and SDS-BMI ( d  = 0.21) were all significantly improved after participating in the 10-week intervention.","['Children with Overweight or Obesity Aged 7 to 13 Years after Participating in a 10-Week Lifestyle Intervention', 'children with overweight and obesity after participating in a 10-week family-based combined lifestyle group intervention in their community', '340 children with overweight or obesity aged between 7 and 13 years, as well as one of their primary caregivers, took part in this intervention, in a real-world setting', 'children with overweight and obesity']",[],"['Pediatric Quality of Life Inventory 4.0 (PedsQL) and Impact of Weight on Quality of Life-Kids (IWQOL-KIDS) questionnaires', 'mean attendance rate', 'HRQOL and BMI (standard deviation [SDS] of BMI, objectively measured', 'SDS-BMI', 'Health-Related Quality of Life and Weight Status', 'health-related quality of life (HRQOL) and weight status', 'weight-specific quality of life', 'Generic quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0449719', 'cui_str': 'Part'}]",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]",340.0,0.0233863,"Results:  Generic quality of life ( Z  = -3.58,  r  = -0.25), weight-specific quality of life ( Z  = -4.83,  r  = -0.34), and SDS-BMI ( d  = 0.21) were all significantly improved after participating in the 10-week intervention.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'van den Eynde', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Roxanna', 'Initials': 'R', 'LastName': 'Camfferman', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Putten', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Carry M', 'Initials': 'CM', 'LastName': 'Renders', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jacob C', 'Initials': 'JC', 'LastName': 'Seidell', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jutka', 'Initials': 'J', 'LastName': 'Halberstadt', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Institute, Amsterdam, the Netherlands.'}]",Childhood obesity (Print),['10.1089/chi.2020.0070']
1437,32707101,The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).,"BACKGROUND


Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
METHODS


We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
PROJECTED OUTCOMES


This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.",2020,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","['partnership with a primary care clinic in a low-income, majority Latino community', 'Families with 2- to 5-year-old children', 'integrated primary care (the healthy communities 4 healthy students study']",['Family Check-Up 4 Health (FCU4Health) program'],"['RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance', 'cost, acceptability, appropriateness, and feasibility', 'child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",,0.0514529,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","[{'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': ""REACH Institute, Arizona State University, Tempe, AZ, USA; Phoenix Children's Hospital, Phoenix, AZ, USA. Electronic address: Cady.Berkel@asu.edu.""}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology (Ce-PIM), Department of Psychiatry and Behavioral Sciences, Department of Preventive Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Meg M', 'Initials': 'MM', 'LastName': 'Bruening', 'Affiliation': 'Department of Nutrition, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Winslow', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ray', 'Affiliation': 'Bayless Integrated Healthcare, Phoenix, AZ, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bourne', 'Affiliation': 'Southwest Maricopa Regional Council, First Things First, Peoria, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106088']
1438,32710787,Blood 15N:13C Enrichment Ratios Are Proportional to the Ingested Quantity of Protein with the Dual-Tracer Approach for Determining Amino Acid Bioavailability in Humans.,"BACKGROUND


Assessment of amino acid bioavailability is of key importance for the evaluation of protein quality; however, measuring ileal digestibility of dietary proteins in humans is challenging. Therefore, a less-invasive dual stable isotope tracer approach was developed.
OBJECTIVE


We aimed to test the assumption that the 15N:13C enrichment ratio in the blood increases proportionally to the quantity ingested by applying different quantities of 15N test protein.
METHODS


In a crossover design, 10 healthy adults were given a semi-liquid mixed meal containing 25 g (low protein) or 50 g (high protein) of 15N-labeled milk protein concentrate simultaneous with 0.4 g of highly 13C-enriched spirulina. The meal was distributed over multiple small portions, frequently provided every 20 min during a period of 160 min. For several amino acids, the blood 15N- related to 13C-isotopic enrichment ratio was determined at t = 0, 30, 60, 90, 120, 180, 240, 300, and 360 min and differences between the 2 meals were compared using paired analyses.
RESULTS


No differences in 13C AUC for each of the measured amino acids in serum was observed when ingesting a low- or high-protein meal, whereas 15N AUC of amino acids was ∼2 times larger on the high-protein meal (P < 0.001). Doubling the intake of 15N-labeled amino acids increased the 15N:13C ratio by a factor of 2.04 ± 0.445 for lysine and a factor between 1.8 and 2.2 for other analyzed amino acids, with only phenylalanine (2.26), methionine (2.48), and tryptophan (3.02) outside this range.
CONCLUSIONS


The amino acid 15N:13C enrichment ratio in the peripheral circulation increased proportionally to the quantity of 15N-labeled milk protein ingested, especially for lysine, in healthy adults. However, when using 15N-labeled protein, correction for, e.g., α-carbon 15N atom transamination is advised for determination of bioavailability of individual amino acids. This trial was registered at www.clinicaltrials.gov as NCT02966704.",2020,"The amino acid 15N:13C enrichment ratio in the peripheral circulation increased proportionally to the quantity of 15N-labeled milk protein ingested, especially for lysine, in healthy adults.","['10 healthy adults', 'healthy adults']",['semi-liquid mixed meal containing 25 g (low protein) or 50 g (high protein) of 15N-labeled milk protein concentrate simultaneous with 0.4 g of highly 13C-enriched spirulina'],"['13C AUC', '13C-isotopic enrichment ratio', '15N:13C ratio', 'amino acids in serum', 'Blood 15N:13C']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026138', 'cui_str': 'Milk protein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",10.0,0.0251836,"The amino acid 15N:13C enrichment ratio in the peripheral circulation increased proportionally to the quantity of 15N-labeled milk protein ingested, especially for lysine, in healthy adults.","[{'ForeName': 'Nikkie', 'Initials': 'N', 'LastName': 'van der Wielen', 'Affiliation': 'Division of Human Nutrition, Wageningen University and Research, Wageningen, Netherlands.'}, {'ForeName': 'Nadezda V', 'Initials': 'NV', 'LastName': 'Khodorova', 'Affiliation': 'UMR Physiologie de la nutrition et du comportement alimentaire, AgroParisTech, National Research Institute for Agriculture, Food and Environment, Université Paris-Saclay, Paris, France.'}, {'ForeName': 'Walter J J', 'Initials': 'WJJ', 'LastName': 'Gerrits', 'Affiliation': 'Animal Nutrition Group, Wageningen University and Research, Wageningen, Netherlands.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Gaudichon', 'Affiliation': 'UMR Physiologie de la nutrition et du comportement alimentaire, AgroParisTech, National Research Institute for Agriculture, Food and Environment, Université Paris-Saclay, Paris, France.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Calvez', 'Affiliation': 'UMR Physiologie de la nutrition et du comportement alimentaire, AgroParisTech, National Research Institute for Agriculture, Food and Environment, Université Paris-Saclay, Paris, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Tomé', 'Affiliation': 'UMR Physiologie de la nutrition et du comportement alimentaire, AgroParisTech, National Research Institute for Agriculture, Food and Environment, Université Paris-Saclay, Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mensink', 'Affiliation': 'Division of Human Nutrition, Wageningen University and Research, Wageningen, Netherlands.'}]",The Journal of nutrition,['10.1093/jn/nxaa205']
1439,32716291,A novel rizatriptan oral gel formulation: Bioavailability and bioequivalence.,"OBJECTIVES


To establish the relative bioavailability between a newly developed oral gel and a marketed oral lyophilisate-containing rizatriptan benzoate.
MATERIALS AND METHODS


A total of 47 out of 48 healthy subjects, aged 34 ± 10 (SD) years and body mass index 24.7 ± 3.3 (SD) kg/m 2  completed this single-center, open-label, randomized, 2-period cross-over trial with single-dose fasted administrations. Intake of both investigational products was separated by a washout period of at least 6 days. For pharmacokinetic evaluation, blood samples were withdrawn until 24 hours post dose. A validated liquid chromatography-tandem mass spectrometry method (LC-MS/MS) was applied for the determination of rizatriptan in plasma. The lower limit of quantitation (LLOQ) was 0.100 ng/mL. Adverse events (AEs) were descriptively analyzed in the study population. Palatability of the new product was investigated based on a questionnaire.
RESULTS


The geometric means of the parameters related with the extent of total exposure, i.e., AUC 0-tlast  and AUC 0-∞ , were 60.285 ng × h/mL and 60.865 ng × h/mL for test and 62.729 ng × h/mL and 63.312 ng × h/mL for reference, respectively. The geometric means of the peak exposure, i.e., C max , were 21.262 ng/mL for test and 21.447 ng/mL for reference. The point estimates (PEs) of the test/reference (T/R) adjusted geometric mean ratios of AUC 0-tlast , C max , and AUC 0-∞  (secondary parameter) were 96.11%, 99.12%, and 96.15%, respectively, and all of them showed 90% confidence intervals (CIs) within the range of 80.00 - 125.00% as suggested by regulatory requirements for bioequivalence assessment. In total, 13 subjects experienced 20 AEs during the trial; the most frequently reported AEs were headache (5 cases) and dizziness (3 cases). No AEs of severe intensity were reported. Palatability assessment of the new product provided sufficient data to discuss its acceptability.
CONCLUSION


Bioequivalence was demonstrated in terms of rate and extent of absorption after administration of test and reference products. Concerning the safety evaluation, no negative implications on the possible use of the test formulation could be determined. Based on ratings by the subjects no relevant problem concerning acceptability of the new formulation in particular regarding taste and smell is to be expected.",2020,Based on ratings by the subjects no relevant problem concerning acceptability of the new formulation in particular regarding taste and smell is to be expected.,"['A total of 47 out of 48 healthy subjects, aged 34 ± 10 (SD) years and body mass index 24.7 ± 3.3 (SD) kg/m2 completed this single-center, open-label, randomized, 2-period cross-over trial with single-dose fasted administrations']",['rizatriptan'],"['headache', 'dizziness', 'lower limit of quantitation (LLOQ', 'severe intensity', 'relative bioavailability', 'geometric mean ratios of AUC 0-tlast , C max , and AUC 0-∞']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517688', 'cui_str': '3.3'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0297635', 'cui_str': 'rizatriptan'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.078419,Based on ratings by the subjects no relevant problem concerning acceptability of the new formulation in particular regarding taste and smell is to be expected.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Tellone', 'Affiliation': ''}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Dragone', 'Affiliation': ''}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Picollo', 'Affiliation': ''}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Rosignoli', 'Affiliation': ''}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Garofolo', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Del Vecchio', 'Affiliation': ''}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Calisti', 'Affiliation': ''}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Comandini', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Donath', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schug', 'Affiliation': ''}, {'ForeName': 'Ralph-Steven', 'Initials': 'RS', 'LastName': 'Wedemeyer', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203652']
1440,32712347,Impact of myoglobin oxygenation state prior to frozen storage on color stability of thawed beef steaks through retail display.,"Consumers consider beef color to be an indicator of freshness and therefore it is a major factor when purchasing beef. The ideal conditions for maintaining color throughout retail display following frozen storage have yet to be well established. Therefore, the objective of this study was to determine the effects of myoglobin oxygenation levels (especially high oxygenation) during freezing on color stability of thawed steaks during retail display (RD) and to determine the impact that frozen storage duration, aging, and packaging films have on meat color after thawing under RD conditions. USDA Choice strip loins (n = 36) were aged for 4 or 20 d. Steaks were randomly assigned to a myoglobin oxygenation level [deoxymyoglobin (DeOxy; packaged within 3 min), oxygenation (Oxy; oxygenated in air for 30 min), or high oxygenation (HiOxy; packaged for 24 h in 80% O 2 )]. Steaks were then vacuum packaged in oxygen permeable or impermeable film and immediately frozen (-10 °C). Following either 0, 2, 4, or 6 months of frozen storage at -5 °C, steaks were removed from the packaging and immediately placed under simulated RD conditions for 7 d. During RD, instrumental color and subjective color were measured every day after the initial 24 h thaw period. Steaks were analyzed for instrumental color (L*, a*, b*), a*:b* ratio, percentage oxymyoglobin, metmyoglobin, and deoxymyoglobin, delta E, redness ratio, subjective discoloration, and lipid oxidation. For all days of RD, steaks that were frozen for 0 months had higher a* values (greater redness) than steaks frozen for 6 months which typically had the lowest a* values (P < .0001). HiOxy steaks frozen for 6 months had the lowest amounts of percentage oxymyoglobin than all other frozen storage periods and myoglobin oxygenation levels on days 4-7 of RD (P < .05). The HiOxy steaks frozen for 4 and 6 months had higher percentage metmyoglobin than DeOxy and Oxy, regardless of packaging (P < .05). Delta E, discoloration, and lipid oxidation were greatest for HiOxy steaks compared to Oxy and DeOxy (P < .05). Extended storage brought about detrimental color effects for all differing levels of myoglobin oxygenation. The HiOxy steaks through the first few days of RD and frozen for under 6 months provided had bright cherry red color, similar to that of DeOxy and Oxy. However, with extended frozen storage and RD, HiOxy steaks had worse color characteristics (more discoloration) than the other myoglobin oxygenation levels.",2020,HiOxy steaks frozen for 6 months had the lowest amounts of percentage oxymyoglobin than all other frozen storage periods and myoglobin oxygenation levels on days 4-7 of RD (P ,['n\xa0=\xa036) were aged for 4 or 20\xa0d. Steaks'],"['myoglobin oxygenation state prior to frozen storage', 'USDA Choice strip loins', 'myoglobin oxygenation level [deoxymyoglobin (DeOxy; packaged within 3\xa0min), oxygenation (Oxy; oxygenated in air for 30\xa0min), or high oxygenation (HiOxy']","['myoglobin oxygenation levels', 'percentage oxymyoglobin, metmyoglobin, and deoxymyoglobin, delta E, redness ratio, subjective discoloration, and lipid oxidation', 'Delta E, discoloration, and lipid oxidation', 'color stability']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0085410', 'cui_str': 'Department of Agriculture (U.S.)'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0446502', 'cui_str': 'Loin (surface region)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0057444', 'cui_str': 'deoxymyoglobin'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0069830', 'cui_str': 'oxymyoglobin'}, {'cui': 'C0025852', 'cui_str': 'Metmyoglobin'}, {'cui': 'C0057444', 'cui_str': 'deoxymyoglobin'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",36.0,0.0389964,HiOxy steaks frozen for 6 months had the lowest amounts of percentage oxymyoglobin than all other frozen storage periods and myoglobin oxygenation levels on days 4-7 of RD (P ,"[{'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Henriott', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln 68583-0908, USA.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Herrera', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln 68583-0908, USA.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln 68583-0908, USA.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Hart', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln 68583-0908, USA.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Bland', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln 68583-0908, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eskridge', 'Affiliation': 'Department of Statistics, University of Nebraska, Lincoln 68583-0908, USA.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Calkins', 'Affiliation': 'Department of Animal Science, University of Nebraska, Lincoln 68583-0908, USA. Electronic address: ccalkins1@unl.edu.'}]",Meat science,['10.1016/j.meatsci.2020.108232']
1441,32697145,Re: Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 mL): 6-Month Results from the WATER II Trial.,,2020,,['Benign Prostatic Hyperplasia in Large Prostates (80-150 mL'],[],[],"[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0426732', 'cui_str': 'Large prostate'}, {'cui': 'C4321486', 'cui_str': '150'}]",[],[],,0.0279485,,"[{'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001205']
1442,32692952,Posterior Rotational and Translational Stability in Acromioclavicular Ligament Complex Reconstruction: A Comparative Biomechanical Analysis in Cadaveric Specimens.,"BACKGROUND


Persistent posterior instability of the acromioclavicular (AC) joint is a reported complication after isolated coracoclavicular (CC) reconstruction. Thus, multiple techniques have been proposed attempting to restore biomechanics of the AC ligament complex (ACLC).
PURPOSE/HYPOTHESIS


The purpose was to evaluate the posterior translational and rotational stability of an ACLC reconstruction with a dermal allograft (ACLC patch) as compared with 3 suture brace constructs. It was hypothesized that the ACLC patch would better restore AC joint posterior stability.
STUDY DESIGN


Controlled laboratory study.
METHODS


A total of 28 cadaveric shoulders (mean ± SD age, 57.6 ± 8.3 years) were randomly assigned to 1 of 4 surgical techniques: ACLC patch, oblique brace, anterior brace, and x-frame brace. The force and torque to achieve 10 mm of posterior translation and 20° of posterior rotation of the AC joint were recorded in the following conditions: intact, transected ACLC, ACLC patch/brace repair, ACLC patch/brace repair with dissected CC ligaments, and ACLC patch/brace repair with CC ligament repair.
RESULTS


For posterior translation, transection of the ACLC reduced resistance to 16.7% of the native. With the native CC ligaments intact, the ACLC patch (59.1%), oblique brace (54.1%), and anterior brace (60.7%) provided significantly greater stability than the x-frame brace (33.2%;  P  < .001,  P  = .008,  P  < .001, respectively). ACLC patch, oblique brace, and anterior brace continued to have significantly higher posterior translational resistance than the x-frame (35.1%;  P  < .001,  P  = .003,  P  < .001) after transection and subsequent CC ligament repair. For posterior rotation, transection of the ACLC decreased the resistance to 5.4% of the intact state. With the CC ligaments intact, the ACLC patch (77.1%) better restored posterior rotational stability than the oblique (35.3%), anterior (48.5%), and x-frame (23.0%) brace repairs ( P  < .001,  P  = .002,  P  < .001). CC ligament transection and subsequent repair demonstrated the ACLC patch (41.0%) to have improved stability when compared with the oblique (16.0%), anterior (14.0%), and x-frame (12.7%) repairs ( P  = .006,  P  = .003,  P  = .002).
CONCLUSION


ACLC reconstruction with a dermal allograft better restored native posterior rotational stability than other brace constructs, with translational stability similar to the oblique and anterior brace technique at the time of surgery.
CLINICAL RELEVANCE


Horizontal stability of the AC joint is primarily controlled by the ACLC. Inability to restore AC joint biomechanics can result in persistent posterior instability and lead to functional impairment.",2020,"With the CC ligaments intact, the ACLC patch (77.1%) better restored posterior rotational stability than the oblique (35.3%), anterior (48.5%), and x-frame (23.0%) brace repairs ( P  < .001,  P  = .002,  P  < .001).","['Cadaveric Specimens', 'Acromioclavicular Ligament Complex Reconstruction', '28 cadaveric shoulders (mean ± SD age, 57.6 ± 8.3 years']","['ACLC reconstruction with a dermal allograft (ACLC patch', '4 surgical techniques: ACLC patch, oblique brace, anterior brace, and x-frame brace', 'ACLC patch', 'intact, transected ACLC, ACLC patch/brace repair, ACLC patch/brace repair with dissected CC ligaments, and ACLC patch/brace repair with CC ligament repair']","['posterior translational and rotational stability', 'restore AC joint posterior stability', 'anterior brace', 'oblique brace', 'posterior rotational stability', 'posterior translational resistance']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0225039', 'cui_str': 'Structure of acromioclavicular ligament'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}, {'cui': 'C0225040', 'cui_str': 'Coracoclavicular ligament structure'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001208', 'cui_str': 'Acromioclavicular joint structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",28.0,0.0329299,"With the CC ligaments intact, the ACLC patch (77.1%) better restored posterior rotational stability than the oblique (35.3%), anterior (48.5%), and x-frame (23.0%) brace repairs ( P  < .001,  P  = .002,  P  < .001).","[{'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Morikawa', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Joel B', 'Initials': 'JB', 'LastName': 'Huleatt', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Lukas N', 'Initials': 'LN', 'LastName': 'Muench', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Kia', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Berthold', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Elifho', 'Initials': 'E', 'LastName': 'Obopilwe', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Kelolli', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Scheiderer', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}, {'ForeName': 'Augustus D', 'Initials': 'AD', 'LastName': 'Mazzocca', 'Affiliation': 'Department of Orthopaedic Surgery, University of Connecticut, Farmington, Connecticut, USA.'}]",The American journal of sports medicine,['10.1177/0363546520939882']
1443,32692990,Liposomal Bupivacaine Local Infiltration for Buccal Mucosal Graft Harvest Site Pain Control: A Single-blinded Randomized Controlled Trial.,"OBJECTIVE


To assess efficacy and safety of liposomal bupivacaine (LB) infiltration of the buccal mucosal graft (BMG) harvest site in alleviating pain by evaluating the postoperative narcotic usage, pain score, and morbidities.
PATIENTS AND METHODS


Single-blinded randomized controlled trial of 43 adult patients for BMG substitution urethroplasty between January 2015 to June 2017 (Clinicaltrials.gov: NCT03720223). A computer-generated allocation scheme randomized patients to control group (n = 22) no further local anesthetic infiltration aside from that of used in the hydrodissection for BMG harvest, and to intervention group with additional infiltration of LB to BMG harvest site (n = 21). We assessed postoperative cumulative narcotic use on post-op day 1 and 2 (24- and 48-hour total intravenous [IV] morphine equivalents in milligrams). A self-reported 10-point numeric rating scale survey was administered to assess postprocedural oral pain, oral conditions, and morbidity on days 1-3, and at 1-month follow-up. Fisher's exact test and independent T test were performed to assess differences between treatment groups. Linear regression was used to determine adjusted effect estimates of intervention.
RESULTS


Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day 1 (IV morphine equivalent mean difference 8.58 mg; 95% confidence interval 1.59, 15.56, P =.017), while no significant difference was noticed on post-op day 2. There was no significant difference between treatment groups with regards to postprocedural oral pain score or oral morbidities.
CONCLUSION


Our study showed that LB infiltration of the BMG harvest site is safe and associated with lower 24-hour narcotic use only at post-op day 1.",2020,"Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day-1","['43 adult patients for BMG substitution urethroplasty between January 2015 to June 2017', 'Buccal Mucosal Graft Harvest Site Pain Control']","['liposomal bupivacaine (LB', 'Liposomal Bupivacaine']","['narcotic use', 'postoperative cumulative narcotic', 'post-procedural oral pain score or oral morbidities']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0450135', 'cui_str': 'Mucosal graft'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",43.0,0.0844186,"Compared to controls, a significantly lower narcotic use was noticed among the LB treatment group on post-op day-1","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Chua', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Zuckerman', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA; Department of Urology, Naval Medical Center, Portsmouth, VA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strehlow', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA; Spartanburg Medical Center, Spartanburg, SC.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Virasoro', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'DeLong', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Tonkin', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA.'}, {'ForeName': 'Kurt A', 'Initials': 'KA', 'LastName': 'McCammon', 'Affiliation': 'Department of Urology, Eastern Virginia Medical School, Norfolk, VA; Devine-Jordan Center for Reconstructive Surgery and Pelvic Health, Urology of Virginia, Virginia Beach, VA. Electronic address: mccammKa@evms.edu.'}]",Urology,['10.1016/j.urology.2020.06.067']
1444,32693097,"Improving management of the genitourinary syndrome of menopause: evaluation of a health system-based, cluster-randomized intervention.","BACKGROUND


Genitourinary symptoms are common in postmenopausal women and adversely affect the quality of life. National surveys and data collected from our healthcare system indicate that postmenopausal women with the genitourinary syndrome of menopause often fail to receive appropriate diagnosis or treatment.
OBJECTIVE


To promote greater detection and treatment of the genitourinary syndrome of menopause, we created and tested a clinician-focused health system intervention that included clinician education sessions and a suite of evidence-based electronic health record tools.
STUDY DESIGN


Using a cluster-randomized design, we allocated primary care (16) and gynecology (6) clinics to the intervention or control group. From September to November 2014, we provided training about the diagnosis and treatment of genitourinary syndrome of menopause in face-to-face presentations at each intervention clinic and in an online video. We developed clinical decision support tools in the electronic health record that contained an evidence-based, point-of-care knowledge resource, a standardized order set, and a checklist of patient education materials for the patient's after visit summary. The tools aimed to facilitate accurate diagnostic coding and prescribing (SmartSet, SmartRx) along with relevant patient information (SmartText). Clinicians who only performed visits at control clinics received no training or notification about the tools. Our primary outcome was vulvovaginal diagnoses made at well visits for women at the age of 55 years and older from November 15, 2014 to November 15, 2015. We also assessed urinary diagnoses, vaginal estrogen prescriptions, and use of the electronic tools. There was departmental support for the intervention but no prioritization within the healthcare system to incentivize change.
RESULTS


In the 1-year period, 386 clinicians performed 14,921 well visits for women at the age of 55 years and older. Among the 190 clinicians who performed well visits in the intervention clinics, 109 (57.4%) completed either in-person or online educational training. The proportion of visits that included a vulvovaginal (7.2% vs 5.8%; odds ratio, 1.27; 95% confidence interval, 0.65-2.51) or urinary diagnosis (2.5% vs 3.1%; odds ratio, 0.79; 95% confidence interval, 0.55-1.13) or vaginal estrogen prescription (4.5% vs 3.7%; odds ratio, 1.24; 95% confidence interval, 0.63-2.46) did not differ between study arms. There was a significant interaction for primary care and gynecology, which revealed more vulvovaginal diagnoses by gynecology but not primary care intervention clinics (odds ratio, 1.63; 95% confidence interval, 1.15-2.31), but there was no significant interaction for prescriptions. Clinicians in the intervention clinics were more likely to use decision support tools than those in control clinics-SmartSet (22.2% vs 1.5%; odds ratio, 18.8; 95% confidence interval, 5.5-63.8) and SmartText for patient information (38.0% vs 24.4%; odds ratio, 1.91; 95% confidence interval, 1.10-3.34). A per-protocol analysis revealed similar findings.
CONCLUSION


Overall, the intervention did not lead to more diagnoses or prescription therapy for postmenopausal genitourinary symptoms but did result in greater distribution of patient information. Gynecology clinicians were more likely to address genitourinary symptoms generally and were more likely to make a vulvovaginal diagnosis after the intervention. Further efforts for improving care should consider ongoing clinician education beginning with enhanced menopause curricula in residency training. Additional interventions to consider include greater access for postmenopausal women to gynecologic care, addressing treatment barriers, and development of national performance metrics.",2020,Clinicians in the intervention clinics were more likely to use decision support tools compared to those in control clinics--SmartSet (22.2% vs.1.5%),"['postmenopausal women with the genitourinary syndrome of menopause often fail to receive appropriate diagnosis or treatment', '386 clinicians performed 14,921 well visits for women aged 55 and older', 'women aged 55 and older from 11/15/14 through 11/15/15', 'postmenopausal women', 'postmenopausal women to gynecologic care', '190 clinicians who performed well visits in the intervention clinics, 109 (57.4%) completed either in-person or']","['gynecology (6) clinics to intervention or control', 'online educational training']","['vaginal estrogen prescription', 'proportion of visits that included a vulvovaginal', 'urinary diagnosis', 'postmenopausal genitourinary symptoms', 'vulvovaginal diagnoses', 'vulvovaginal diagnosis', 'vulvovaginal diagnoses made at well visits']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0426317', 'cui_str': 'Genitourinary symptoms'}]",,0.0627479,Clinicians in the intervention clinics were more likely to use decision support tools compared to those in control clinics--SmartSet (22.2% vs.1.5%),"[{'ForeName': 'Kimberly K', 'Initials': 'KK', 'LastName': 'Vesco', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR; Department of Obstetrics and Gynecology, Kaiser Permanente Northwest, Portland, OR. Electronic address: kimberly.k.vesco@kpchr.org.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Bulkey', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'Kate R', 'Initials': 'KR', 'LastName': 'Beadle', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente Northwest, Portland, OR.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Stoneburner', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Francisco', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR; Department of Obstetrics and Gynecology, Kaiser Permanente Northwest, Portland, OR.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.029']
1445,32698830,Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial.,"BACKGROUND


Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28-57% cases. Glucocorticoids, administered through oral or intratympanic way, are currently regularly and standardly applied for ISSNHL to improve the hearing outcome. However, the vestibular prognosis of ISSNHL after routine treatments remains seldom explored. This study aims to compare the effectiveness of oral and intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.
METHODS/DESIGN


A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. Seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo or imbalance will be recruited and randomized into either oral or intratympanic glucocorticoid therapy group with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, cervical vestibular evoked myogenic potential, and ocular vestibular evoked myogenic potential; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessments of primary outcomes will be performed at baseline and at 4 and 8 weeks post-randomization, while assessments of secondary outcomes will be performed at baseline and 1, 2, 4, and 8 weeks post-randomization.
DISCUSSION


Previous intervention studies of ISSNHL included only hearing outcomes, with little attention paid on the prognosis of vestibular dysfunction. This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. The efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03974867 . Registered on 23 July 2019.",2020,"The efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone.
",['Seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo or imbalance'],"['oral or intratympanic glucocorticoids', 'oral and intratympanic glucocorticoids', 'Glucocorticoids', 'glucocorticoids', 'oral or intratympanic glucocorticoid therapy']","['vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, cervical vestibular evoked myogenic potential, and ocular vestibular evoked myogenic potential; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4720873', 'cui_str': 'Sensory organization test'}, {'cui': 'C0006778', 'cui_str': 'Caloric vestibular test'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3658201', 'cui_str': 'Head impulse test'}, {'cui': 'C2936455', 'cui_str': 'Cervical Vestibular Evoked Myogenic Potentials'}, {'cui': 'C2936454', 'cui_str': 'Ocular Vestibular Evoked Myogenic Potentials'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}]",72.0,0.111893,"The efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone.
","[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Hao', 'Affiliation': ""ENT Institute and Otorhinolaryngology Department of Eye & ENT Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, 83 Fenyang Road, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""ENT Institute and Otorhinolaryngology Department of Eye & ENT Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, 83 Fenyang Road, Shanghai, 200031, People's Republic of China.""}, {'ForeName': 'Huiqian', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""ENT Institute and Otorhinolaryngology Department of Eye & ENT Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, 83 Fenyang Road, Shanghai, 200031, People's Republic of China. yhq925@163.com.""}, {'ForeName': 'Huawei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""ENT Institute and Otorhinolaryngology Department of Eye & ENT Hospital, State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, 83 Fenyang Road, Shanghai, 200031, People's Republic of China. huaweili2000@163.com.""}]",Trials,['10.1186/s13063-020-04579-6']
1446,32700432,A Randomized Controlled Pilot Study Comparing the Efficacy of Pulsed Radiofrequency Combined With Exercise Versus Exercise Alone in Pain Relief and Functional Improvement for Chronic Knee Osteoarthritis.,"OBJECTIVES


To compare the long-term efficacy between pulsed radiofrequency (PRF) combined with passive stretching (PRF-PS) exercise and PS exercise alone in reducing pain and improving quadriceps muscle strength and knee function.
METHODS


Sixty-two participants were randomly assigned with a 1:1 allocation to the PRF-PS exercise group or the PS exercise group. Level of pain, muscle strength, and knee function were assessed from baseline to the first, third, and sixth months after treatment using the VAS, peak torque (PT), and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), respectively.
RESULTS


There were no significant differences at baseline between the 2 groups. Compared to exercise alone, participants achieved superior efficacy with PRF-PS in pain relief, improvement of muscle strength, and knee function. Moreover, the improvement of all variables was maintained for a longer period of time in the PRF-PS group. The reduction in participants' VAS pain intensity scores was superior for PRF-PS vs. PS with overall estimation (adjusted mean difference: -1.85 cm; 95% confidence interval [CI] -2.25, -1.45 cm; P = 0.000). The increase in participants' PT scores was superior for PRF-PS vs. PS with overall estimation (adjusted mean difference: 15.53 N. m; 95% CI 7.07, 23.98 N. m; P = 0.000; and 12.62 N. m; 95% CI 0.96, 24.28 N. m; P = 0.000 for PT 60 degrees/s and PT 180 degrees/s, respectively). The reduction in participants' WOMAC scores was superior for PRF-PS vs. PS with overall estimation (adjusted mean difference: -16.43; 95% CI -22.22, -10.64; P = 0.000).
DISCUSSION


The improvement in pain relief and knee function might be associated with restoration of muscle strength after PRF-PS exercise by overcoming muscle inhibition.",2020,"Compared to exercise, participants achieved superior efficacy of PRF-PS exercise in pain relief, improvement of muscle strength and knee function.","['chronic knee osteoarthritis', 'Sixty-two participants']","['pulsed radiofrequency (PRF) combined with passive stretching (PRF-PS) exercise and PS exercise alone', 'PRF-PS exercise', 'PRF-PS exercise group or PS exercise group', 'Pulsed Radiofrequency combined with Exercise versus Exercise']","['WOMAC score', 'pain relief and functional improvement', 'pain and improving quadriceps muscle strength and knee function', 'PT score', 'pain relief, improvement of muscle strength and knee function', 'Level of pain, muscle strength and knee function', 'pain relief and knee function', 'VAS, peak torque (PT) and WOMAC, respectively', 'VAS pain intensity', 'efficacy improvement']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",62.0,0.137443,"Compared to exercise, participants achieved superior efficacy of PRF-PS exercise in pain relief, improvement of muscle strength and knee function.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': 'Department of Pain Management, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Yantao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Pain Management, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Jia', 'Affiliation': 'Department of Pain Management, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Pain Management, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Pain Management, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Pain Management, Huadong Hospital Affiliated to Fudan University, Shanghai, China.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12942']
1447,32702255,"Re: Long-Term Effect of Community-Based Continence Promotion on Urinary Symptoms, Falls and Health Active Life Expectance among Older Women: Cluster Randomised Trial.",,2020,,['Older Women'],['Community-Based Continence Promotion'],"['Urinary Symptoms, Falls and Health Active Life Expectance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0837289,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.01']
1448,32702256,"Re: Testosterone for Androgen Deficiency-Like Symptoms in Men without Pathologic Hypogonadism: A Randomized, Placebo-Controlled Cross-Over with Masked Choice Extension Clinical Trial.",,2020,,['Men without Pathologic Hypogonadism'],"['Re: Testosterone', 'Placebo']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.745346,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.04']
1449,32702258,"Re: A Group-Based Yoga Program for Urinary Incontinence in Ambulatory Women: Feasibility, Tolerability, and Change in Incontinence Frequency over 3 Months in a Single-Center Randomized Trial.",,2020,,['Ambulatory Women'],['Re: A Group-Based Yoga Program'],[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0157535,,"[{'ForeName': 'Tomas L', 'Initials': 'TL', 'LastName': 'Griebling', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001207.02']
1450,32706638,First Randomized Trial Supporting the Use of Proton Over Photon Chemoradiotherapy in Esophageal Cancer.,,2020,,['Esophageal Cancer'],['Proton Over Photon Chemoradiotherapy'],[],"[{'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]",[],,0.0869142,,"[{'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Simone', 'Affiliation': 'Department of Radiation Oncology, New York Proton Center and Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01405']
1451,32706639,"Cancer and Leukemia Group B 90203 (Alliance): Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy in Localized, High-Risk Prostate Cancer.","PURPOSE


Radical prostatectomy (RP) alone is often inadequate in curing men with clinically localized, high-risk prostate cancer (PC). We hypothesized that chemohormonal therapy (CHT) with androgen-deprivation therapy plus docetaxel before RP would improve biochemical progression-free survival (BPFS) over RP alone.
PATIENTS AND METHODS


Men with clinically localized, high-risk PC were assigned to RP alone or neoadjuvant CHT with androgen deprivation plus docetaxel (75 mg/m 2  body surface area every 3 weeks for 6 cycles) and RP. The primary end point was 3-year BPFS. Biochemical failure was defined as a serum prostate-specific antigen level > 0.2 ng/mL that increased on 2 consecutive occasions that were at least 3 months apart. Secondary end points included 5-year BPFS, overall BPFS, local recurrence, metastasis-free survival (MFS), PC-specific mortality, and overall survival (OS).
RESULTS


In total, 788 men were randomly assigned. Median follow-up time was 6.1 years. The overall rates of grade 3 and 4 adverse events during chemotherapy were 26% and 19%, respectively. No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89  v  0.84, respectively; 95% CI for the difference, -0.01 to 0.11;  P  = .11). Neoadjuvant CHT was associated with improved overall BPFS (hazard ratio [HR], 0.69; 95% CI, 0.48 to 0.99), improved MFS (HR, 0.70; 95% CI, 0.51 to 0.95), and improved OS (HR, 0.61; 95% CI, 0.40 to 0.94) compared with RP alone.
CONCLUSION


The primary study end point, 3-year BPFS, was not met. Although some improvement was seen in secondary end points, any potential benefit must be weighed against toxicity. Our data do not support the routine use of neoadjuvant CHT and RP in patients with clinically localized, high-risk PC at this time.",2020,"No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89  v  0.84, respectively; 95% CI for the difference, -0.01 to 0.11;  P  = .11).","['Cancer and Leukemia Group B 90203 (Alliance', '788 men were randomly assigned', 'curing men with clinically localized, high-risk prostate cancer (PC', 'Men with clinically localized, high-risk PC']","['Neoadjuvant CHT', 'RP alone or neoadjuvant CHT with androgen deprivation plus docetaxel', 'chemohormonal therapy (CHT) with androgen-deprivation therapy plus docetaxel', 'Radical prostatectomy (RP) alone', 'Radical Prostatectomy With or Without Neoadjuvant Chemohormonal Therapy']","['overall rates of grade 3 and 4 adverse events', 'MFS', 'overall BPFS', '3-year BPFS', 'Biochemical failure', '5-year BPFS, overall BPFS, local recurrence, metastasis-free survival (MFS), PC-specific mortality, and overall survival (OS', 'biochemical progression-free survival (BPFS']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",788.0,0.220039,"No difference was seen in 3-year BPFS between neoadjuvant CHT plus RP and RP alone (0.89  v  0.84, respectively; 95% CI for the difference, -0.01 to 0.11;  P  = .11).","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Eastham', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Heller', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Monk', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, The James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Himisha', 'Initials': 'H', 'LastName': 'Beltran', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gleave', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Evans', 'Affiliation': 'University of California, Davis, Sacramento, CA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Clinton', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, The James Cancer Hospital, Columbus, OH.'}, {'ForeName': 'Russell Z', 'Initials': 'RZ', 'LastName': 'Szmulewitz', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Colleen R', 'Initials': 'CR', 'LastName': 'Watt', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Sanda', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Olwen M', 'Initials': 'OM', 'LastName': 'Hahn', 'Affiliation': 'Alliance Protocol Operations Office, University of Chicago, Chicago, IL.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'University of California, San Diego, San Diego, CA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California, San Francisco, Medical Center-Mount Zion, San Francisco, CA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00315']
1452,32707403,"Changes to stance limb peak, cumulative, and regional plantar foot forces among normal walking and three mobility aids in healthy older adults.","BACKGROUND


Mobility aids are commonly prescribed to offload an injured lower extremity. Device selection may impact stance foot loading patterns and foot health in clinical populations at risk of foot ulceration.
RESEARCH QUESTIONS


Two questions motivated this study: How does device selection influence peak plantar and regional (rearfoot, mid foot and forefoot) foot forces on the stance foot? Does device selection influence peak, cumulative, and regional plantar forces within a 200 m walking trial?
METHODS


Twenty-one older adults walked 200 m at self-selected pace in four randomized conditions for this prospective crossover study. Participants used a walker, crutches, wheeled knee walker (WKW), and no assistive device (control condition). Plantar forces were measured using a wireless in-shoe system (Loadsol, Novel Inc., St. Paul, MN). Repeated measures analyses of variance were used to determine differences in peak and cumulative total and regional forces among walking conditions. Paired sample t-tests compared forces during first and last 30 s epochs of each condition to determine device influence over time.
RESULTS


The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions. Crutch use had similar peak forces as control. There were no differences in the number of steps taken within devices comparing first and last epochs. Crutches had a 0.04 and 0.07 BW increase in peak net and forefoot forces during the last epoch. Walker use had 66.44 BW lower cumulative forefoot forces in the last epoch.
SIGNIFICANCE


Crutches had similar stance foot loading as normal walking while a walker lowered forefoot forces at the expense of increased steps. A WKW may be the best choice to 'protect' tissues in the stance foot from exposure to peak and cumulative forces in the forefoot region.",2020,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"['healthy older adults', 'Twenty-one older adults walked 200 m at self-selected pace']",['normal walking and three mobility aids'],"['device selection influence peak, cumulative, and regional plantar forces', 'peak net forces', 'Plantar forces', 'peak net and forefoot forces', 'stance limb peak, cumulative, and regional plantar foot forces', 'peak and cumulative total and regional forces among walking conditions', 'cumulative forefoot forces']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3495449', 'cui_str': 'Mobility aid'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",21.0,0.0456241,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kingston', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada. Electronic address: david.kingston@usask.ca.'}, {'ForeName': 'A Gary', 'Initials': 'AG', 'LastName': 'Linassi', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada; School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: anl931@mail.usask.ca.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Zucker-Levin', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: audrey.zuckerlevin@usask.ca.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.015']
1453,32715754,Fidaxomicin for the treatment of  Clostridioides difficile  in children.,"Fidaxomicin is an oral narrow-spectrum novel 18-membered macrocyclic antibiotic that was initially approved in 2011 by the US FDA for the treatment of  Clostridioides difficile  infections (CDI) in adults. In February 2020, the FDA approved fidaxomicin for the treatment of CDI in children age >6 months. In adults, fidaxomicin is as efficacious as vancomycin in treating CDI and reduces the risk of recurrent CDI. An investigator-blinded, randomized, multicenter, multinational clinical trial comparing the efficacy and safety of fidaxomicin with vancomycin in children was recently published confirming similar findings as previously reported in adults. Fidaxomicin is the first FDA-approved treatment for CDI in children and offers a promising option for reducing recurrent CDI in this population.",2020,"In adults, fidaxomicin is as efficacious as vancomycin in treating CDI and reduces the risk of recurrent CDI.",['Clostridioides difficile  in children'],"['fidaxomicin', 'Fidaxomicin', 'vancomycin', 'fidaxomicin with vancomycin']",[],"[{'cui': 'C0079134', 'cui_str': 'Clostridium difficile (bacteria)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0065023', 'cui_str': 'fidaxomicin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]",[],,0.0536865,"In adults, fidaxomicin is as efficacious as vancomycin in treating CDI and reduces the risk of recurrent CDI.","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Skinner', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Loyola University Medical Center, Maywood, IL, USA.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Scardina', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Larry K', 'Initials': 'LK', 'LastName': 'Kociolek', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}]",Future microbiology,['10.2217/fmb-2020-0104']
1454,32715915,"Re: Evaluating the Safety and Potential Activity of URO-902 (hMaxi-K) Gene Transfer by Intravesical Instillation or Direct Injection into the Bladder Wall in Female Participants with Idiopathic (Non-Neurogenic) Overactive Bladder Syndrome and Detrusor Overactivity from Two Double-Blind, Imbalanced, Placebo-Controlled Randomized Phase 1 Trials.",,2020,,['Female Participants with Idiopathic (Non-Neurogenic) Overactive Bladder Syndrome and Detrusor Overactivity'],"['URO-902', 'hMaxi-K) Gene Transfer by Intravesical Instillation or Direct Injection']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}]","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",[],,0.212251,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001223.02']
1455,32716603,The effect of adjuvant oral irrigation on self-administered oral care in the management of peri-implant mucositis: A randomized controlled clinical trial.,"OBJECTIVES


This single-blinded randomized clinical trial evaluated the effect of adjuvant oral irrigation in addition to self-administered oral care on prevalence and severity of peri-implant mucositis.
MATERIAL & METHODS


After randomization, patients suffering from peri-implant mucositis were assigned to the following: Group 1 (control) received oral hygiene instruction following a standardized protocol, including a sub- and supramucosal mechanical debridement. Group 2 and 3 additionally were instructed to use an oral irrigator with either water or 0.06% CHX solution. One implant per patient was considered for examination. Clinical examinations included Probing Depth, Bleeding on Probing (BOP-positive sites), and Modified Plaque and Gingival Index. A surrogate variable (mucositis severity score) was applied measuring severity of disease. Statistical analysis included linear regression models and sensitivity analysis.
RESULTS


Sixty periodontally healthy patients were examined for presence and severity of peri-implant mucositis. 70% of all patients reached complete resolution of disease after 12 weeks. The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3. Average BOP-positive sites were reduced in all groups after 12 weeks (mean change from baseline: group 1: -1.5; group 2: -1.8; group 3: -2.3).
CONCLUSION


Within the limits of the study, adjuvant use of an oral irrigator with 0.06% CHX in addition to mechanical biofilm removal and oral hygiene instruction can reduce the presence and severity of peri-implant mucositis after 12 weeks.",2020,"The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3.","['peri-implant mucositis', 'patients suffering from peri-implant mucositis', '60', 'periodontally healthy patients']","['oral hygiene instruction following a standardized protocol, including a sub- and supramucosal mechanical debridement', 'adjuvant oral irrigation', 'oral irrigator with either water or 0.06% CHX solution']","['prevalence of peri-implant mucositis', 'presence and severity of peri-implant mucositis', 'probing depth (PD), bleeding on probing (BOP-positive sites), modified plaque and gingiva-index (mPI, mGI', 'Average BOP-positive sites', 'complete resolution of disease']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0399271', 'cui_str': 'Oral irrigation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0335463', 'cui_str': 'Irrigator'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",60.0,0.0604381,"The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bunk', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eisenburger', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Häckl', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Eberhard', 'Affiliation': 'School of Dentistry and the Charles Perkins Centre, Faculty of Health and Medicine, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Stiesch', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Grischke', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}]",Clinical oral implants research,['10.1111/clr.13638']
1456,32717112,Influence of delayed umbilical cord clamping on pain during suture of perineal tears: A randomised controlled study.,"OBJECTIVE


This study investigated whether the delayed umbilical cord clamping can influence the pain during suturing perineal tears.
DESIGN


This randomised controlled study applied the Consolidated Standards of Reporting Trials statement.
METHODS


The sample comprised 288 pregnant women who gave birth through vaginal delivery in our hospital from November 2019 to December 2019. They were randomly divided into 2 groups-early umbilical cord clamping (n = 147) and delayed umbilical cord clamping (n = 141)-without severe pregnancy complications. There was no intrauterine infection, neonatal asphyxia or premature birth in the 288 newborns. The pain scores of the Numerical Rating Scale, Visual Analogue Scale, Verbal Rating Scale and Faces Pain Scale-Revised were used as indicators to evaluate the mothers' pain. The Mann-Whitney U test was used, and the statistical significance was set to p < .05.
RESULT


All indicators suggest that perineal suture pain of delayed umbilical cord clamping was lower than that of the control group. For the experience group, the perception of pain for the mothers who received analgesia was less than that for those who did not. For the control group, the Verbal Rating Scale suggests a statistical difference in suturing pain between acceptable and unacceptable labour analgesia. The degree of cooperation of the experience group was higher than that of the control group, but labour analgesia did not affect cooperation degree in both groups.
CONCLUSION


Delayed umbilical cord clamping can alleviate maternal pain when suturing perineal tears and improve the delivery experience. Labour analgesia can enhance the pain relief effect. Trial registration was performed on www.chictr.org.cn (ChiCTR1900026797).
RELEVANCE TO CLINICAL PRACTICE


As a part of perinatal nursing, delayed umbilical cord clamping can help alleviate the pain of perineal suture and improve the experience of parturient. The method is simple and can be used as a routine nursing operation.",2020,"For the control group, the Verbal Rating Scale suggests a statistical difference in suturing pain between acceptable and unacceptable labor analgesia.","['288 pregnant women who gave birth through vaginal delivery in our hospital from November 2019 to December 2019', 'pain during suture of perineal tears']","['Delayed umbilical cord clamping', 'Labor analgesia', 'umbilical cord clamping (n=147) and delayed umbilical cord clamping', 'delayed umbilical cord clamping']","['intrauterine infection, neonatal asphyxia, or premature birth', ""pain scores of the Numerical Rating Scale, Visual Analogue Scale, Verbal Rating Scale, and Faces Pain Scale-Revised were used as indicators to evaluate the mothers' pain"", 'suturing pain between acceptable and unacceptable labor analgesia', 'perineal suture pain of delayed umbilical cord clamping', 'labor analgesia', 'maternal pain', 'Verbal Rating Scale', 'pain', 'perception of pain', 'pain relief effect']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0404427', 'cui_str': 'Repair of perineal tear'}]","[{'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}]","[{'cui': 'C1112157', 'cui_str': 'Intrauterine infection'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0405737', 'cui_str': 'Umbilical cord clamping'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",288.0,0.0279898,"For the control group, the Verbal Rating Scale suggests a statistical difference in suturing pain between acceptable and unacceptable labor analgesia.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Cuicun', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Obstetrics, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, China.'}]",Journal of clinical nursing,['10.1111/jocn.15421']
1457,32718943,Effect of Low-dose and Standard-dose Aspirin on PGE 2  Biosynthesis Among Individuals with Colorectal Adenomas: A Randomized Clinical Trial.,"Low-dose aspirin is recommended by the U.S. Preventive Services Task Force for primary prevention of colorectal cancer in certain individuals. However, broader implementation will require improved precision prevention approaches to identify those most likely to benefit. The major urinary metabolite of PGE 2 , 11α-hydroxy-9,15-dioxo-2,3,4,5-tetranor-prostane-1,20-dioic acid (PGE-M), is a biomarker for colorectal cancer risk, but it is unknown whether PGE-M is modifiable by aspirin in individuals at risk for colorectal cancer. Adults ( N  = 180) who recently underwent adenoma resection and did not regularly use aspirin or NSAIDs were recruited to a double-blind, placebo-controlled, randomized trial of aspirin at 81 or 325 mg/day for 8-12 weeks. The primary outcome was postintervention change in urinary PGE-M as measured by LC/MS. A total of 169 participants provided paired urine samples for analysis. Baseline PGE-M excretion was 15.9 ± 14.6 (mean ± S.D, ng/mg creatinine). Aspirin significantly reduced PGE-M excretion (-4.7 ± 14.8) compared with no decrease (0.8 ± 11.8) in the placebo group ( P  = 0.015; mean duration of treatment = 68.9 days). Aspirin significantly reduced PGE-M levels in participants receiving either 81 (-15%;  P  = 0.018) or 325 mg/day (-28%;  P  < 0.0001) compared with placebo. In 40% and 50% of the individuals randomized to 81 or 325 mg/day aspirin, respectively, PGE-M reduction reached a threshold expected to prevent recurrence in 10% of individuals. These results support that aspirin significantly reduces elevated levels of PGE-M in those at increased colorectal cancer risk to levels consistent with lower risk for recurrent neoplasia and underscore the potential utility of PGE-M as a precision chemoprevention biomarker. The ASPIRED trial is registered as NCT02394769.",2020,Aspirin significantly reduced PGE-M levels in participants receiving either 81 (-15%; p=0.018) or 325 mg/day (-28%; p<0.0001) compared to placebo.,"['Individuals with Colorectal Adenomas', 'Adults (N=180) who recently underwent adenoma resection and did not regularly use aspirin or non-steroidal anti-inflammatory drugs', 'individuals at risk for CRC', '169 participants provided paired urine samples for analysis']","['placebo', 'Aspirin', 'Low-dose and Standard-dose Aspirin', 'aspirin']","['Baseline PGE-M excretion', 'recurrence', 'PGE-M excretion', 'PGE-M levels', 'post-intervention change in urinary PGE-M as measured by liquid-chromatography mass spectrometry', 'PGE2 Biosynthesis']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0049896', 'cui_str': 'prostaglandin M'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}]",169.0,0.217073,Aspirin significantly reduced PGE-M levels in participants receiving either 81 (-15%; p=0.018) or 325 mg/day (-28%; p<0.0001) compared to placebo.,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Drew', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Madeline M', 'Initials': 'MM', 'LastName': 'Schuck', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marina V', 'Initials': 'MV', 'LastName': 'Magicheva-Gupta', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kathleen O', 'Initials': 'KO', 'LastName': 'Stewart', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Gilpin', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Miller', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Melanie P', 'Initials': 'MP', 'LastName': 'Parziale', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'Pond', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Takacsi-Nagy', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Dylan C', 'Initials': 'DC', 'LastName': 'Zerjav', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Chin', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mackinnon Krems', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Meixell', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Amit D', 'Initials': 'AD', 'LastName': 'Joshi', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Colizzo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Carolan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Norman S', 'Initials': 'NS', 'LastName': 'Nishioka', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Staller', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Richter', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Gala', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Garber', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Chung', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Yarze', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Zukerberg', 'Affiliation': 'Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Petrucci', 'Affiliation': 'Institute of Pharmacology, Catholic University School of Medicine and IRCCS Fondzione Policlinico Gemielli, Rome, Italy.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Rocca', 'Affiliation': 'Institute of Pharmacology, Catholic University School of Medicine and IRCCS Fondzione Policlinico Gemielli, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Patrono', 'Affiliation': 'Institute of Pharmacology, Catholic University School of Medicine and IRCCS Fondzione Policlinico Gemielli, Rome, Italy.'}, {'ForeName': 'Ginger L', 'Initials': 'GL', 'LastName': 'Milne', 'Affiliation': 'Division of Clinical Pharmacology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Chan', 'Affiliation': 'Clinical & Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. achan@mgh.harvard.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0216']
1458,32725584,"Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients ≥ 65 years with Overactive Bladder-Wet.","BACKGROUND


In older patients with overactive bladder (OAB), mirabegron, a β 3 -adrenoreceptor agonist, represents an alternative treatment that may have a favorable risk-benefit profile.
OBJECTIVES


Our objective was to further examine the safety and tolerability of mirabegron versus placebo treatment in patients aged ≥ 65 years with OAB-wet.
METHODS


We conducted a 12-week, double-blind, randomized, placebo-controlled phase IV study to compare mirabegron with placebo. Community-dwelling patients aged ≥ 65 years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24 h over a 3-day diary) were randomized to receive placebo or mirabegron 25 mg/day (optional dose escalation to 50 mg/day at week 4 or 8). Safety analyses were performed for adverse events (AEs) and vital signs on all randomized patients who received one or more dose of study drug.
RESULTS


Treatment-emergent AEs (TEAEs), the majority mild or moderate in severity, were reported in 39.4% of placebo patients and 44.2 and 49.8% of those who received mirabegron 25 mg or 50 mg, respectively. The most common TEAEs in mirabegron-treated patients were urinary tract infection, headache, and diarrhea. The incidence of TEAEs was slightly higher in mirabegron patients aged ≥ 75 years than in those aged < 75 years. There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups. TEAEs tended to occur early post exposure and were not dose related.
CONCLUSIONS


Mirabegron treatment was well-tolerated in older adults with OAB-wet. Safety and tolerability were consistent with the known mirabegron safety profile.
TRIAL REGISTRATION


This study is registered at ClinicalTrials.gov: NCT02216214.",2020,"There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups.","['patients aged\u2009≥', '65\xa0years with OAB-wet (one or more incontinence episode and three or more urgency episodes, and an average of eight or more micturitions/24\xa0h over a 3-day diary', 'older adults with OAB-wet', '65\xa0years with OAB-wet', 'Patients\u2009≥', '65\xa0years with Overactive Bladder-Wet', 'Community-dwelling patients aged\u2009≥', 'older patients with overactive bladder (OAB']","['Placebo', 'placebo']","['vital signs', 'Safety and tolerability', 'safety and tolerability', 'incidence of TEAEs', 'Safety and Tolerability', 'urinary tract infection, headache, and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.543871,"There were no clinically meaningful differences in changes in vital signs from baseline to end of treatment for any treatment group, and no differences were observed between mirabegron and placebo treatment groups.","[{'ForeName': 'Sender', 'Initials': 'S', 'LastName': 'Herschorn', 'Affiliation': 'Department of Surgery/Urology, Sunnybrook Health Sciences Centre, University of Toronto, 2075 Bayview Avenue, MG408, Toronto, Ontario, M4N 3M5, Canada. s.herschorn@utoronto.ca.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': ""Division of Urology, St Elizabeth's Medical Center, 736 Cambridge Street, Brighton, MA, USA.""}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Schermer', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Kristy', 'Affiliation': 'Astellas Pharma Global Development, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wagg', 'Affiliation': 'Department of Medicine, University of Alberta, 1-198 Clinical Sciences Building, 11350 83 Avenue, Edmonton, AB, Canada.'}]",Drugs & aging,['10.1007/s40266-020-00783-w']
1459,32729404,Central Sympathetic Nervous System Effects on Cognitive-Motor Performance.,"The intriguing interplay between acute stress physiology and cognitive processes has long been noted. However, while stress-induced release of glucocorticoids has repeatedly been shown to impact brain mechanisms underlying cognition and memory, less experimental research addressed the effects of stress-induced central sympathetic nervous system (SNS) activation on cognitive performance. Moreover, despite the long-standing notion that the way performance is modulated by arousal may crucially depend on task complexity, mechanistic research demonstrating a direct, causal influence of altered SNS activity is scarce. Twelve healthy men participated in a placebo-controlled, pharmacologic dose-response study involving three within-subject assessments (1-week intervals). Subjective and objective indices of SNS activity as well as reaction time (RT) in three different tasks varying in cognitive demand (simple RT, choice RT, and verbal RT in complex mental arithmetic) were assessed during modulation of central SNS tone by intravenous infusions of dexmedetomidine (alpha2-agonist), yohimbine (alpha2-antagonist), and placebo. Cognitive performance was negatively affected by alpha2-agonism in all task conditions. By contrast, administration of yohimbine improved simple RT, while diminishing complex RT, supporting the assumption of a nonlinear way of action depending on task characteristics. Our results highlight the consequences of central (noradrenergic) SNS activation for cognitive-motor performance in RT tasks of varying complexity.",2020,"Subjective and objective indices of SNS activity as well as reaction time (RT) in three different tasks varying in cognitive demand (simple RT, choice RT, and verbal RT in complex mental arithmetic) were assessed during modulation of central SNS tone by intravenous infusions of dexmedetomidine (alpha2-agonist), yohimbine (alpha2-antagonist), and placebo.",['Twelve healthy men participated in a'],"['dexmedetomidine (alpha2-agonist), yohimbine (alpha2-antagonist), and placebo', 'yohimbine', 'placebo']","['Cognitive performance', 'cognitive demand (simple RT, choice RT, and verbal RT in complex mental arithmetic', 'Cognitive-Motor Performance', 'reaction time (RT']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",12.0,0.040691,"Subjective and objective indices of SNS activity as well as reaction time (RT) in three different tasks varying in cognitive demand (simple RT, choice RT, and verbal RT in complex mental arithmetic) were assessed during modulation of central SNS tone by intravenous infusions of dexmedetomidine (alpha2-agonist), yohimbine (alpha2-antagonist), and placebo.","[{'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Finke', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, University of Trier, Trier, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schächinger', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, University of Trier, Trier, Germany.'}]",Experimental psychology,['10.1027/1618-3169/a000475']
1460,32729888,Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial.,"Importance


Faricimab, the first bispecific antibody designed for intraocular use, simultaneously and independently binds and neutralizes angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).
Objective


To assess the efficacy and safety of different doses and regimens of faricimab vs ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
Design, Setting, and Participants


AVENUE was a 36-week, multiple-dose-regimen, active comparator-controlled, double-masked, phase 2 randomized clinical study performed at 58 sites in the United States. Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320). Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017. Data were analyzed from August 11, 2015, to October 4, 2019.
Interventions


Patients were randomized 3:2:2:2:3 to receive ranibizumab, 0.5 mg every 4 weeks (arm A [n = 68]); faricimab, 1.5 mg every 4 weeks (arm B [n = 47]); faricimab, 6.0 mg every 4 weeks (arm C [n = 42]); faricimab, 6.0 mg every 4 weeks until week 12, then faricimab, 6.0 mg every 8 weeks (arm D [n = 47]); and ranibizumab, 0.5 mg every 4 weeks until week 8, then faricimab, 6.0 mg every 4 weeks (arm E [n = 69]).
Main Outcomes and Measures


Mean change in BCVA from baseline to week 36, proportion of participants gaining at least 15 letters, BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes in anti-VEGF treatment-naive participants (arms A, B, C, D) and from weeks 12 to 36 in those with incomplete response (participants in arms A and E with week 12 BCVA ETDRS letter score of ≤68 [Snellen equivalent, 20/50 or worse]).
Results


A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years). At week 36, adjusted mean change in BCVA vs ranibizumab was 1.6 (80% CI, -1.6 to 4.7) letters for arm B (P = .52), -1.6 (80% CI, -4.9 to 1.7) letters for arm C (P = .53), and -1.5 (80% CI, -4.6 to 1.6) letters for arm D (P = .53). For arm E, adjusted mean change from week 12 was -1.7 (80% CI, -3.8 to 0.4) letters (P = .30).
Conclusions and Relevance


AVENUE did not meet its primary end point of superiority of faricimab over ranibizumab in BCVA at week 36. Although not superior to monthly ranibizumab as given in this trial, overall visual and anatomical gains noted with faricimab support pursuing phase 3 trials for a potential alternative to monthly anti-VEGF therapy. Faricimab showed no new or unexpected safety signals.
Trial Registration


ClinicalTrials.gov Identifier: NCT02484690.",2020,"For arm E, adjusted mean change from week 12 was -1.7","['Data were collected from August 11, 2015, to January 12, 2017, with the final patient visit completed September 26, 2017', 'A total of 263 participants were included in the analysis (172 [65.4%] female; 258 [98.1%] white; mean [SD] age, 78.3 [8.7] years', 'Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 73 (Snellen equivalent, 20/40) to 24 (Snellen equivalent, 20/320', 'Neovascular Age-Related Macular Degeneration', 'patients with neovascular age-related macular degeneration (nAMD', 'Eligible participants were anti-VEGF treatment naive with choroidal neovascularization secondary to nAMD and best-corrected visual acuity (BCVA']","['faricimab vs ranibizumab', 'Faricimab vs Ranibizumab', 'BCVA', 'ranibizumab']","['efficacy and safety', 'BCVA of 20/40 or better or 20/200 or worse, and ocular coherence tomographic outcomes', 'Safety and Efficacy']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0442752', 'cui_str': 'Distance vision 6/12'}, {'cui': 'C0442756', 'cui_str': 'Distance vision 6/60'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",263.0,0.321469,"For arm E, adjusted mean change from week 12 was -1.7","[{'ForeName': 'Jayashree', 'Initials': 'J', 'LastName': 'Sahni', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Patel', 'Affiliation': 'West Texas Retina Consultants, Abilene.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Chittum', 'Affiliation': 'Retina Consultants of Southern Colorado, Colorado Springs.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Retina Research Center, Austin, Texas.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Del Valle Rubido', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Shamil', 'Initials': 'S', 'LastName': 'Sadikhov', 'Affiliation': 'Roche Product Development, F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Szczesny', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Schwab', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Everson', 'Initials': 'E', 'LastName': 'Nogoceke', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weikert', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Fauser', 'Affiliation': 'Roche Innovation Center Basel, Roche Pharma Research and Early Development, F. Hoffman-La Roche Ltd, Basel, Switzerland.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2685']
1461,32726475,Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care.,"BACKGROUND


Group visits can support health behavior change and self-efficacy. In primary care, an advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement.
OBJECTIVE


To determine whether the ENgaging in Advance Care Planning Talks (ENACT) group visits intervention improves ACP documentation and readiness in older adults.
METHODS


This randomized clinical trial was conducted among geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019. Participants randomized to ENACT group visits (n = 55) participated in two 2-hour sessions with discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos). Participants randomized to the control arm (n = 55) received the Conversation Starter Kit and a Medical Durable Power of Attorney form by mail. The primary outcomes included presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR) at 6 months, and a secondary outcome was ACP readiness (validated four-item ACP Engagement Survey) at 6 months.
RESULTS


Participants were a mean of 77 years old, 60% female, and 79% white. At 6 months, 71% of ENACT participants had an advance directive in the EHR (26% higher) compared with 45% of control arm participants (P < .001). Similarly, 93% of ENACT participants had decision-maker documentation in the EHR (29% higher) compared with 73% in the control arm (P < .001). ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
CONCLUSION


An ACP group visit increased ACP documentation and readiness to engage in ACP behavior change. Primary care teams can explore implementation and adaptation of ACP group visits into routine care, as well as longer-term impact on patient health outcomes.",2020,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
","['geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019', 'Participants were a mean of 77\u2009years old, 60% female, and 79% white', 'older adults', 'Older Adults in Primary Care']","['discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos', 'Conversation Starter Kit and a Medical Durable Power of Attorney form by mail', 'ENgaging in Advance Care Planning Talks (ENACT) group visits intervention', 'ACP', 'Advance Care Planning Group Visits', 'advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement', 'ENACT']","['readiness to engage in ACP', 'presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR', 'decision-maker documentation', 'ACP documentation and readiness', 'ACP documentation and readiness to engage in ACP behavior change', 'advance directive in the EHR']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0586806', 'cui_str': 'Power of attorney observable'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]",,0.0679267,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
","[{'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Lum', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dukes', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Division of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.'}, {'ForeName': 'Prajakta', 'Initials': 'P', 'LastName': 'Shanbhag', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine , Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Cari R', 'Initials': 'CR', 'LastName': 'Levy', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value Driven Care, Eastern Colorado Health Care System, Aurora, Colorado, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16694']
1462,32734366,"A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc ®  Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts.","INTRODUCTION


Anogenital warts (AGW) are a relevant clinical issue in the field of sexually transmitted disease, and to date no treatment provides a satisfactory clearance rate. Treatment can be both medical and surgical, and be provided by a healthcare provider or by the patient. Cryotherapy (CRYO) is among the most common treatments for AGW. Nitrizinc® Complex solution (NZCS) is a solution containing organic acids, nitric acid and zinc and copper salts that is applied topically to warts, producing mummification of the damaged tissue. It is considered to be an effective and well-tolerated treatment for genital and common warts. The aim of our study was to compare NZCS to CRYO in the treatment of AGW.
METHODS


We performed a prospective, multicentre, single-blind, randomised, superiority clinical study involving 120 patients, aged 18-55 years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW. The patients were treated either with NZCS or CRYO for a maximum of four treatments. Primary endpoints were: (1) comparison of the clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire at the end of each treatment session. Secondary endpoints were: (1) number of treatments needed for clearance; and (2) recurrence at 1 and 3e months after confirmed clearance. The results were analysed on an intention-to-treat basis.
RESULTS


A complete response was achieved in 89.7% of the NZCS group and in 75.4% of the CRYO group (p = 0.0443). NZCS was found to be better tolerated. There was no difference between the NZCS and CRYO treatment arms in the number of sessions needed to clear the lesions. Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
CONCLUSIONS


Nitrizinc® Complex solution can be considered to be as effective as CRYO for the treatment of small (< 5 mm) external AGW, with a better tolerability profile and lower rate of recurrence.
TRIAL REGISTRATION


ISRCTN identifier, ISRCTN36102369.",2020,"Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
","['120 patients, aged 18-55\xa0years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW', 'Anogenital Warts']","['Nitrizinc® Complex solution (NZCS', 'Topical Nitrizinc ®  Complex Solution Versus Cryotherapy', 'Cryotherapy (CRYO', 'NZCS or CRYO', 'NZCS']","['number of sessions needed to clear the lesions', 'tolerated', 'Recurrence', 'clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire', '1) number of treatments needed for clearance; and (2) recurrence']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",120.0,0.0861442,"Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pontini', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy. pontini.p@gmail.com.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Mastorino', 'Affiliation': 'Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Gaspari', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Granger', 'Affiliation': 'Innovation and Development, ISDIN, Barcelona, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ramoni', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Delmonte', 'Affiliation': 'Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Evangelista', 'Affiliation': ""Unit of Dermatology, Head and Neck Department, Sant'Orsola Malpighi University Hospital, Bologna, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Cusini', 'Affiliation': ""Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.""}]",Dermatology and therapy,['10.1007/s13555-020-00430-7']
1463,32730561,Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis.,"Importance


Nonoperative management with antibiotics alone has the potential to treat uncomplicated pediatric appendicitis with fewer disability days than surgery.
Objective


To determine the success rate of nonoperative management and compare differences in treatment-related disability, satisfaction, health-related quality of life, and complications between nonoperative management and surgery in children with uncomplicated appendicitis.
Design, Setting, and Participants


Multi-institutional nonrandomized controlled intervention study of 1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019. Of the 1209 eligible patients approached, 1068 enrolled in the study.
Interventions


Patient and family selection of nonoperative management with antibiotics alone (nonoperative group, n = 370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n = 698).
Main Outcomes and Measures


The 2 primary outcomes assessed at 1 year were disability days, defined as the total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care (expected difference, 5 days), and success rate of nonoperative management, defined as the proportion of patients initially managed nonoperatively who did not undergo appendectomy by 1 year (lowest acceptable success rate, ≥70%). Inverse probability of treatment weighting (IPTW) was used to adjust for differences between treatment groups for all outcome assessments.
Results


Among 1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery. A total of 806 (75%) had complete follow-up: 284 (77%) in the nonoperative group; 522 (75%) in the surgery group. Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%). After IPTW, the success rate of nonoperative management at 1 year was 67.1% (96% CI, 61.5%-72.31%; P = .86). Nonoperative management was associated with significantly fewer patient disability days at 1 year than did surgery (adjusted mean, 6.6 vs 10.9 days; mean difference, -4.3 days (99% CI, -6.17 to -2.43; P < .001). Of 16 other prespecified secondary end points, 10 showed no significant difference.
Conclusion and Relevance


Among children with uncomplicated appendicitis, an initial nonoperative management strategy with antibiotics alone had a success rate of 67.1% and, compared with urgent surgery, was associated with statistically significantly fewer disability days at 1 year. However, there was substantial loss to follow-up, the comparison with the prespecified threshold for an acceptable success rate of nonoperative management was not statistically significant, and the hypothesized difference in disability days was not met.
Trial Registration


ClinicalTrials.gov Identifier: NCT02271932.",2020,"Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%).","['1209 eligible patients approached, 1068 enrolled in the study', ""1068 children aged 7 through 17 years with uncomplicated appendicitis treated at 10 tertiary children's hospitals across 7 US states between May 2015 and October 2018 with 1-year follow-up through October 2019"", 'Children With Uncomplicated Appendicitis', 'children with uncomplicated appendicitis', '1068 patients who were enrolled (median age, 12.4 years; 38% girls), 370 (35%) chose nonoperative management and 698 (65%) chose surgery']","['Antibiotic Therapy vs Laparoscopic Appendectomy', 'antibiotics alone', 'antibiotics alone (nonoperative group, n\u2009=\u2009370) or urgent (≤12 hours of admission) laparoscopic appendectomy (surgery group, n\u2009=\u2009698']","['total number of days the child was not able to participate in all of his/her normal activities secondary to appendicitis-related care', 'disability, satisfaction, health-related quality of life, and complications', 'patient disability days', 'Inverse probability of treatment weighting (IPTW', 'success rate', 'success rate of nonoperative management']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517543', 'cui_str': '12.4'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",1068.0,0.123447,"Patients in the nonoperative group were more often younger (median age, 12.3 years vs 12.5 years), Black (9.6% vs 4.9%) or other race (14.6% vs 8.7%), had caregivers with a bachelor's degree (29.8% vs 23.5%), and underwent diagnostic ultrasound (79.7% vs 74.5%).","[{'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Minneci', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Lawrence', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Yuri V', 'Initials': 'YV', 'LastName': 'Sebastião', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'Saito', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Grace Z', 'Initials': 'GZ', 'LastName': 'Mak', 'Affiliation': 'Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Section of Pediatric Surgery, Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Illinois.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Hirschl', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gadepalli', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Helmrath', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Kohler', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Leys', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Thomas T', 'Initials': 'TT', 'LastName': 'Sato', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Dave R', 'Initials': 'DR', 'LastName': 'Lal', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Landman', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Kabre', 'Affiliation': ""Division of Pediatric Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois.""}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Fallat', 'Affiliation': 'Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, Kentucky.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Cooper', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Deans', 'Affiliation': ""Center for Surgical Outcomes Research, Abigail Wexner Research Institute at Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10888']
1464,32730613,Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.,"Importance


National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
Objective


To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.
Design, Setting, and Participants


A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.
Interventions


The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.
Main Outcomes and Measures


Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).
Results


Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).
Conclusions and Relevance


This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.
Trial Registration


ClinicalTrials.gov Identifier: NCT02505425.",2020,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","['patients with advanced heart failure, which disproportionately affects rural and minority populations', '415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals', 'Patients and Caregivers', '415 participants (221 men', ' baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n\u2009=\u2009208) or usual care (n\u2009=\u2009207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0', 'patients with advanced heart failure', 'Patients With Heart Failure']","['early palliative care telehealth intervention', 'Early Palliative Care Telehealth Intervention vs Usual Care', 'person palliative care consultation and 6 weekly nurse-coach telephonic sessions']","['mean (SE) KCCQ score', 'pain intensity and interference', 'quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores ≥50 are considered ""fairly good"" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS', 'global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits', 'quality of life, mood, global health, pain, and resource use', 'mood (HADS-anxiety, d\u2009', 'quality of life or mood', 'mean (SE) FACIT-Pal-14 score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0441785', 'cui_str': 'Stage C'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0562342', 'cui_str': 'Empowered'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.155537,"At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]).","[{'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steinhauser', 'Affiliation': 'Center for Innovation, Veterans Affairs Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin.'}, {'ForeName': 'Raegan W', 'Initials': 'RW', 'LastName': 'Durant', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Rodney O', 'Initials': 'RO', 'LastName': 'Tucker', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2861']
1465,32737900,Nitric oxide added to the sweep gas of the oxygenator during cardiopulmonary bypass in infants: A pilot randomized controlled trial.,"Our objective was to assess the effect of nitric oxide added to the sweep gas of the oxygenator during cardiopulmonary bypass (CPB) in infants on platelet count, platelet function, clinical outcomes, and safety. A randomized, double-blinded, placebo-controlled clinical trial in infants less than a year of age undergoing cardiac surgery requiring CPB was undertaken. Nitric oxide at a dose of 20 ppm was added to the sweep gas in the treatment group. Blood was collected at baseline and prior to separation from CPB to measure platelet count and function as determined by responsiveness to specific agonists. Clinical outcomes were observed through hospital discharge. Methemoglobin levels were measured preoperatively, at the conclusion of CPB, and upon admission to the ICU. Forty patients consented and were randomized in the trial. Eighteen patients were randomized to the treatment group and 22 were included in the placebo group. The groups were similar in terms of age, weight, gender, and surgical complexity. No significant differences were found in measures of platelet count, platelet response to agonist, or clinical outcomes. Patients in the treatment group had higher methemoglobin levels after receiving nitric oxide, but no levels approached toxicity (maximum 2.4%). Nitric oxide added to the sweep gas of the oxygenator during CPB in infants did not have an appreciable effect on the preservation of platelet count, platelet responsiveness to agonist, or clinical outcomes. Methemoglobin levels were increased after receiving nitric oxide but were far below a toxic level of 15%.",2020,"No significant differences were found in measures of platelet count, platelet response to agonist, or clinical outcomes.","['infants less than a year of age undergoing cardiac surgery requiring CPB was undertaken', 'Infants', 'Forty patients consented and were randomized in the trial', 'Eighteen patients were randomized to the treatment group and twenty-two were included in the']","['Nitric Oxide Added to the Sweep Gas of the Oxygenator', 'nitric oxide', 'Nitric oxide', 'placebo']","['platelet count, platelet response to agonist, or clinical outcomes', 'Methemoglobin levels', 'toxicity', 'platelet count, platelet function, clinical outcomes, and safety', 'hospital discharge', 'methemoglobin levels']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025635', 'cui_str': 'Methemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",18.0,0.13949,"No significant differences were found in measures of platelet count, platelet response to agonist, or clinical outcomes.","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Niebler', 'Affiliation': 'Departments of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Chiang-Ching', 'Affiliation': 'School of Public Health, University of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Daley', 'Affiliation': ""Herma Heart Institute, Children's Wisconsin, Milwaukee, WI, USA.""}, {'ForeName': 'Rae', 'Initials': 'R', 'LastName': 'Janecke', 'Affiliation': 'Versiti Blood Research Institute, Milwaukee, WI, USA.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'Jobe', 'Affiliation': 'Departments of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Mitchell', 'Affiliation': ""Herma Heart Institute, Children's Wisconsin, Milwaukee, WI, USA.""}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Varner', 'Affiliation': ""Herma Heart Institute, Children's Wisconsin, Milwaukee, WI, USA.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Woods', 'Affiliation': 'Departments of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Scott', 'Affiliation': ""Herma Heart Institute, Children's Wisconsin, Milwaukee, WI, USA.""}]",Artificial organs,['10.1111/aor.13788']
1466,32736046,"Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double-dummy, double-blind placebo controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants' parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out.
AIM OF THE STUDY


In the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil).
MATERIALS AND METHODS


Fifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 μg/mL isoquercitrin.
RESULTS


Our study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level.
CONCLUSIONS


It seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients.",2020,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"['primary chronic insomnia', 'Fifty patients with primary chronic insomnia']","['violet oil, saffron oil, and lettuce seeds oil nasal drop', 'placebo (sesame oil', 'TPM-treatment or placebo', 'TPM', 'intranasal dosage form containing saffron, lettuce seeds and sweet violet', 'herbal oil or placebo', 'placebo']","['ISI scores', 'mean ISI scores', 'chronic insomnia', 'PSQI scores', 'ISI and PSQI scores', 'Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242765', 'cui_str': 'Lettuce'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330464', 'cui_str': 'Viola odorata'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",50.0,0.415055,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"[{'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Taherzadeh', 'Affiliation': 'Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khaluyan', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Iranshahy', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Eshaghi Ghalibaf', 'Affiliation': 'Anesthesiology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Behjat', 'Initials': 'B', 'LastName': 'Javadi', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: javadib@mums.ac.ir.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113116']
1467,32736164,The presence of a caregiver is associated with patient outcomes in patients with Parkinson's disease and atypical parkinsonisms.,"INTRODUCTION


Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver. Although caregivers can play a key role in supporting patients, little is known about how and whether PD patients with and without caregivers differ in terms of physical, cognitive, and mood outcomes. This study explored whether caregiver presence was associated with variations in patient presentation and outcomes in a palliative PD and atypical PD population.
METHODS


Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada. Measures included: MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale.
RESULTS


Of 210 participants, 175 (83%) had a caregiver. Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale. Despite poorer cognitive and motor function, those with caregivers had higher QOL as measured by the Quality of Life in Alzheimer Disease and less spiritual distress. There were no group differences on anxiety, depression, or grief. Caregiver presence moderated the association between lower MoCA score and worse motor symptoms.
CONCLUSION


Findings of the present study highlight the influence of caregiver engagement on PD patient outcomes. These findings have implications for clinical practice and suggest that presence of a caregiver may be an important modifying variable on patient outcomes to examine in future research.",2020,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","['Of 210 participants, 175 (83%) had a caregiver', ""patients with Parkinson's disease and atypical parkinsonisms"", 'Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada', ""Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver""]",[],"['Palliative Performance Scale', 'MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale', 'anxiety, depression, or grief', 'lower MoCA score and worse motor symptoms', 'motor difficulty, lower cognitive scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585086', 'cui_str': 'Has a caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4302185', 'cui_str': 'Atypical Parkinsonism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]",[],"[{'cui': 'C4720846', 'cui_str': 'Palliative performance scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.115968,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","[{'ForeName': 'Lindsay Penny', 'Initials': 'LP', 'LastName': 'Prizer', 'Affiliation': 'Division of General Medicine and Geriatrics, Emory University School of Medicine, 6 Executive Park, 1st Floor, Atlanta, GA, 30329, USA. Electronic address: lprizer@emory.edu.'}, {'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Departments of Neurology and Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Galifianakis', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miyasaki', 'Affiliation': 'Parkinson and Movement Disorders Program, Neuropalliative Care, Department of Medicine, University of Alberta, Canada.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.003']
1468,32741829,Music Playlists for People with Dementia: Trialing A Guide for Caregivers.,"BACKGROUND


Music programs have the potential to provide an effective non-pharmacological tool for caregivers to reduce depression and agitation and increase quality of life in people with dementia. However, where such programs are not facilitated by a trained music therapist, caregivers need greater access to information about how to use music most effectively in response to key challenges to care, and how to pre-empt and manage adverse responses.
OBJECTIVE


This study reports on the trial of a Guide for use of music with 45 people with dementia and their caregivers in residential care facilities and home-based care.
METHODS


The study used a pre-post experimental design in which participants were randomly allocated to a treatment group or a waitlist control group.
RESULTS


Improvements to quality of life were found in the experimental group over the 6-week period. Significant increases in Interest, Responsiveness, Initiation, Involvement, and Enjoyment were reported for individual listening sessions.
CONCLUSION


The Guide can provide an effective protocol for caregivers to follow in selecting music to manage particular challenges to care, confirming the need for caregivers to be prepared to monitor and manage potential negative responses.",2020,"Significant increases in Interest, Responsiveness, Initiation, Involvement, and Enjoyment were reported for individual listening sessions.
","['45 people with dementia and their caregivers in residential care facilities and home-based care', 'People with Dementia', 'people with dementia']","['Music Playlists', 'waitlist control group']","['quality of life', 'Interest, Responsiveness, Initiation, Involvement, and Enjoyment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",45.0,0.0631866,"Significant increases in Interest, Responsiveness, Initiation, Involvement, and Enjoyment were reported for individual listening sessions.
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garrido', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dunne', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': 'MARCS Institute for Brain, Behaviour & Development, Western Sydney University, Penrith, Australia.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'School of Nursing & Midwifery, Western Sydney University, Penrith, Australia.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200457']
1469,32742520,Salivary and Serum Glucose Levels in Diabetes Mellitus Patients versus Control - A Randomised Control Trial.,"Oral fluids provide a readily available and non-invasive medium for the diagnosis of a wide range of diseases and clinical situations. Diabetes mellitus is a common chronic metabolic disorder that affects millions of people. Our objective was to compare the salivary and serum glucose levels in patients with diabetes mellitus and healthy individuals. Two ml of unstimulated whole saliva was collected by the spitting method. Also, 2 ml of the patient's intravenous blood was obtained from the forearm's median cephalic vein. Both the samples were centrifuged at 2000 rpm for 2-3 minutes. Ten μl of both saliva and serum were taken out and added to glucose reagent. These were kept in a temperature-controlled water bath at 37°C for 10 minutes. The color change was noted, and the optical density was measured in a semi-auto analyzer. The presence of glucose was detected in both groups; however, the levels were raised in people with diabetes compared to healthy individuals. The present study indicated a substantial increase in salivary and serum glucose levels in diabetic patients compared to healthy controls. The concentration of glucose in saliva increases with the increase in serum glucose concentration.",2020,"The presence of glucose was detected in both groups; however, the levels were raised in people with diabetes compared to healthy individuals.","['Diabetes Mellitus Patients', 'diabetic patients compared to healthy controls', 'patients with diabetes mellitus and healthy individuals']",[],"['serum glucose concentration', 'concentration of glucose in saliva', 'Salivary and Serum Glucose Levels', 'salivary and serum glucose levels', 'presence of glucose', 'optical density']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439164', 'cui_str': 'OD units'}]",,0.0246428,"The presence of glucose was detected in both groups; however, the levels were raised in people with diabetes compared to healthy individuals.","[{'ForeName': 'Avanindra', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department Of Oral Pathology and Microbiology, Patna Dental College And Hospital, Patna, India.'}, {'ForeName': 'Tanoj', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Department Of Oral Pathology, Patna Dental College And Hospital, Patna, India.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Bhargava', 'Affiliation': 'Department Of Oral Pathology, Manav Rachna Dental College, Faridabad, Hayana, India.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'Department Of Public Health Dentistry, Patna Dental College And Hospital, Patna, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Vaibhav', 'Affiliation': 'Department Of Dentistry, Vardhman Institute Of Medical Science, Pavapuri, Nalanda, Bihar, India.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Kishore', 'Affiliation': 'Bihar Government, Primary Health Centre, Sahdei Buzurg, Vaishali, Bihar, India.'}]",Journal of medicine and life,['10.25122/jml-2020-0062']
1470,32743789,"Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical Investigation.","INTRODUCTION


Over the last few years, it has been demonstrated that a moist environment enhances the healing process and reduces scar formation of wounds. Such moist conditions can be created and maintained using hydrogels. The aim of this study was to evaluate wound healing, cooling efficacy, local tolerability, and cosmetic appearance of abrasive wounds treated with BepanGel wound care hydrogel.
METHODS


This study was designed as a within-person, single-center, randomized, investigator-blind clinical investigation comparing a hydrogel-treated test field with an untreated test field in an abrasive wound model. In 33 subjects, two small superficial wounds were induced on the non-dominant forearms. Wounds were treated with BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone for 11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of the treatment were assessed over 12 investigational days. During follow-up at day 31, the cosmetic appearance of the wounds was evaluated.
RESULTS


On day 12, the test field treated with BepanGel was completely healed in nearly all subjects (97.0%) in contrast with the test field treated with a plaster alone (18.2%, AUC days 2-12  p < 0.0001) as assessed by a blinded investigator. Two-thirds of the unblinded subjects indicated an immediate cooling effect of the hydrogel (p = 0.0555). At the end of the investigation, the cosmetic appearance of the BepanGel-treated test fields scored superior to the fields treated with a plaster alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
CONCLUSION


This evaluation shows that treatment of superficial cutaneous wounds with BepanGel results in improved wound healing as demonstrated by faster wound closure and a considerably better cosmetic appearance, while providing immediate cooling.
TRIAL REGISTRATION NUMBER


EUDAMED-No.: CIV-19-09-029744.",2020,"The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
","['33 subjects, two small superficial wounds were induced on the non-dominant forearms']","['BepanGel and covered with a standard semi-occlusive wound plaster or covered with a plaster alone', 'BepanGel wound care hydrogel']","['cosmetic appearance', 'Wound healing efficacy, cooling effect, and tolerability', 'wound healing, cooling efficacy, local tolerability, and cosmetic appearance', 'tolerated and no signs of infection or adverse events (AEs', 'wound healing', 'immediate cooling effect']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0460977', 'cui_str': 'Plasters'}, {'cui': 'C0886052', 'cui_str': 'Wound care'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]",,0.0224654,"The hydrogel was generally well tolerated and no signs of infection or adverse events (AEs) related to the treatment were observed.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'de Salvo', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Trapp', 'Affiliation': 'Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wigger-Alberti', 'Affiliation': 'Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.'}, {'ForeName': 'Ragna', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Delcour', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Rossel', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.'}, {'ForeName': 'Maarten T', 'Initials': 'MT', 'LastName': 'Huisman', 'Affiliation': 'Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium. mh@oystershell.be.'}]",Dermatology and therapy,['10.1007/s13555-020-00432-5']
1471,32744358,"Efficacy and safety of polyethylene glycol loxenatide as add-on to metformin in patients with type 2 diabetes: A multicentre, randomized, double-blind, placebo-controlled, phase 3b trial.","AIM


To assess the efficacy and safety of polyethylene glycol loxenatide (PEX168), a new glucagon-like peptide-1 receptor agonist, as an add-on to metformin therapy in Chinese patients with type 2 diabetes (T2D).
MATERIALS AND METHODS


This was a multicentre, randomized, double-blind, placebo-controlled phase 3b trial. After metformin monotherapy (≥1500 mg/day) for 8 weeks or more, patients with uncontrolled T2D (HbA1c of 7.0%-10.5%) from 44 sites were randomized (1:1:1) to metformin + placebo, metformin + PEX168 100 μg, and metformin + PEX168 200 μg. The core treatment period lasted for 24 weeks, followed by a 28-week extension period. The primary endpoint was the change in HbA1c levels at week 24. The main secondary endpoint was the proportion of patients with an HbA1c of less than 7.0% at week 24.
RESULTS


The least-square mean (standard error) change in HbA1c levels was significantly greater (P < .001 for superiority) in the PEX168 groups (-1.16% [0.08%] and -1.14% [0.08%] with 100 and 200 μg, respectively) than in the placebo group (0.35% [0.08%]). The proportion of patients with an HbA1c of less than 7.0% at week 24 was significantly higher in the PEX168 100 μg (37.4%) and PEX168 200 μg (40.6%) groups than in the placebo group (16.8%; both P < .001). The gastrointestinal reactions were mild; the risks of hypoglycaemia and weight gain did not increase. Anti-PEX168 antibodies were noted in less than 2% of patients. No treatment-emergent serious adverse events occurred.
CONCLUSION


The subcutaneous injection of PEX168 once a week can effectively, continuously and safely improve HbA1c levels in patients with T2D when combined with metformin.",2020,The least-square mean (standard error) change in HbA1c levels was significantly greater (P < 0.001 for superiority) in PEX168 groups,"['patients with T2DM', 'patients with uncontrolled T2DM [glycated hemoglobin (HbA1c) 7.0%-10.5%] from 44 sites', 'Chinese patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM when combined with']","['metformin monotherapy', 'metformin + placebo, metformin + PEX168 100\u2009μg, and metformin + PEX168 200\u2009μg', 'polyethylene glycol loxenatide (PEX168', 'polyethylene glycol loxenatide', 'PEX168', 'metformin therapy', 'metformin', 'placebo']","['Anti-PEX168 antibodies', 'risks of hypoglycemia and weight gain', 'Efficacy and safety', 'change in HbA1c levels', 'HbA1c levels', 'proportion of patients with HbA1c', 'least-square mean (standard error) change in HbA1c levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079755', 'cui_str': 'PEX168'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4077947', 'cui_str': 'polyethylene glycol loxenatide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4079755', 'cui_str': 'PEX168'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",,0.513072,The least-square mean (standard error) change in HbA1c levels was significantly greater (P < 0.001 for superiority) in PEX168 groups,"[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.""}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Department of Endocrinology and Metabolism, General Hospital of Beijing Military Region, Beijing, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Mo', 'Affiliation': 'Department of Endocrinology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Gangyi', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The PLA Rocket Force Characteristic Medical Center, Beijing, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.""}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ""Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes, Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14163']
1472,32739331,Which brand should be more nervous about nutritional information disclosure: McDonald's or Subway?,"This study examines the health halo and horn effects in the context of two fast food brands commonly associated with healthy and unhealthy food (i.e., Subway and McDonald's). Health halo is consumers' tendency to overestimate the healthiness of certain food categories or items based on a single claim, whereas health horn is the tendency to underestimate it. Specifically, we investigated the moderating effects of nutritional information disclosure and dietary restraint on consumers' behavioral intentions. Two items from the McDonald's and Subway menus each served as stimuli. They represented health halo confirmation (Roast Chicken sandwich) or disconfirmation (Italian Spicy sandwich) and health horn confirmation (Big Mac burger) or disconfirmation (McSpicy Cajun Burger). This study employed a 2 (nutritional information: present vs. absent) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) mixed factorial design. Participants were randomly assigned to one of two experimental conditions (nutritional information: present vs. absent) and presented with all four menu items. There was a decrease in behavioral intentions toward all menu items except the one representing health horn disconfirmation. In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich). The findings not only delineate the different practices companies adopt but also underscore the importance of nutritional information disclosure in helping consumers make healthier food choices.",2020,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[""consumers' behavioral intentions""]","[""absent)\u202f×\u202f4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters"", 'nutritional information disclosure and dietary restraint', ""health halo or horn associated with Subway or McDonald's menu items""]",['behavioral intentions'],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524709', 'cui_str': 'Subways'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0167676,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[{'ForeName': 'Meeyoung', 'Initials': 'M', 'LastName': 'Joe', 'Affiliation': 'Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 505, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: cookie22@yonsei.ac.kr.'}, {'ForeName': 'Seoki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Hospitality Management, The Pennsylvania State University, 217 Mateer Building University Park, PA, 16802, USA. Electronic address: leeseoki@psu.edu.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Dept. of Food & Nutrition, Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 510, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: sham2@yonsei.ac.kr.'}]",Appetite,['10.1016/j.appet.2020.104805']
1473,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE


Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS


The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS


Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2  = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2  = 0.06).
CONCLUSIONS


The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2  = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1474,32693310,The influence of type of feedback during tablet-based delivery of intensive treatment for childhood apraxia of speech.,"PURPOSE


One of the key principles of motor learning supports using knowledge of results feedback (KR, i.e., whether a response was correct / incorrect only) during high intensity motor practice, rather than knowledge of performance (KP, i.e., whether and how a response was correct/incorrect). In the future, mobile technology equipped with automatic speech recognition (ASR) could provide KR feedback, enabling this practice to move outside the clinic, supplementing speech pathology sessions and reducing burden on already stretched speech-language pathology resources. Here, we employ a randomized controlled trial design to test the impact of KR vs KP feedback on children's response to the Nuffield Dyspraxia Programme 3, delivered through an android tablet. At the time of testing, ASR was not feasible and so correctness of responses was decided by the treating clinician.
METHOD


Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS. Both groups attended a university clinic for 1-hr therapy sessions 4 days a week for 3 weeks. One group received high frequency feedback comprised of both KR and KP, in the style of traditional, face-to-face intensive intervention on all days. The other group received high frequency KR + KP feedback on 1 day per week and high frequency KR feedback on the other 3 days per week, simulating the service delivery model of one clinic session per week supported by tablet-based home practice.
RESULTS


Both groups had significantly improved speech outcomes at 4-months post-treatment. Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment. Heterogeneity in response to intervention within the groups suggests that other factors, not measured here, may be having a substantive influence on response to intervention and feedback type.
CONCLUSION


Mobile technology has the potential to increase motivation and engagement with therapy and to mitigate barriers associated with distance and access to speech pathology services. Further research is needed to explore the influence of type and frequency of feedback on motor learning, optimal timing for transitioning from KP to KR feedback, and how these parameters interact with task, child and context-related factors.",2020,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"['childhood apraxia of speech', 'Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS']","['KR vs KP feedback', 'mobile technology equipped with automatic speech recognition (ASR', 'high frequency KR + KP feedback', 'high frequency feedback comprised of both KR and KP']",['speech outcomes'],"[{'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0201653,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McKechnie', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia; Faculty of Health, University of Canberra, Bruce, ACT, Australia. Electronic address: Jacqui.McKechnie@canberra.edu.au.'}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Ahmed', 'Affiliation': 'Texas A&M University at Qatar, Doha, Qatar; Faculty of Engineering, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Texas A & M University, College Station, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106026']
1475,32706534,Vitamin D Supplements for Prevention of Tuberculosis Infection and Disease.,"BACKGROUND


Vitamin D metabolites support innate immune responses to  Mycobacterium tuberculosis . Data from phase 3, randomized, controlled trials of vitamin D supplementation to prevent tuberculosis infection are lacking.
METHODS


We randomly assigned children who had negative results for  M. tuberculosis  infection according to the QuantiFERON-TB Gold In-Tube assay (QFT) to receive a weekly oral dose of either 14,000 IU of vitamin D 3  or placebo for 3 years. The primary outcome was a positive QFT result at the 3-year follow-up, expressed as a proportion of children. Secondary outcomes included the serum 25-hydroxyvitamin D (25[OH]D) level at the end of the trial and the incidence of tuberculosis disease, acute respiratory infection, and adverse events.
RESULTS


A total of 8851 children underwent randomization: 4418 were assigned to the vitamin D group, and 4433 to the placebo group; 95.6% of children had a baseline serum 25(OH)D level of less than 20 ng per milliliter. Among children with a valid QFT result at the end of the trial, the percentage with a positive result was 3.6% (147 of 4074 children) in the vitamin D group and 3.3% (134 of 4043) in the placebo group (adjusted risk ratio, 1.10; 95% confidence interval [CI], 0.87 to 1.38; P = 0.42). The mean 25(OH)D level at the end of the trial was 31.0 ng per milliliter in the vitamin D group and 10.7 ng per milliliter in the placebo group (mean between-group difference, 20.3 ng per milliliter; 95% CI, 19.9 to 20.6). Tuberculosis disease was diagnosed in 21 children in the vitamin D group and in 25 children in the placebo group (adjusted risk ratio, 0.87; 95% CI, 0.49 to 1.55). A total of 29 children in the vitamin D group and 34 in the placebo group were hospitalized for treatment of acute respiratory infection (adjusted risk ratio, 0.86; 95% CI, 0.52 to 1.40). The incidence of adverse events did not differ significantly between the two groups.
CONCLUSIONS


Vitamin D supplementation did not result in a lower risk of tuberculosis infection, tuberculosis disease, or acute respiratory infection than placebo among vitamin D-deficient schoolchildren in Mongolia. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02276755.).",2020,"The incidence of adverse events did not differ significantly between the two groups.
","['8851 children underwent randomization: 4418', 'We randomly assigned children who had negative results for  M. tuberculosis  infection according to the QuantiFERON-TB Gold In-Tube assay (QFT', '29 children in the']","['Vitamin D metabolites', 'vitamin D 3  or placebo', 'Vitamin D supplementation', 'Vitamin D Supplements', 'vitamin D', 'vitamin D supplementation', 'placebo']","['Tuberculosis disease', 'lower risk of tuberculosis infection, tuberculosis disease, or acute respiratory infection', 'positive QFT result at the 3-year follow-up, expressed as a proportion of children', 'acute respiratory infection', 'serum 25-hydroxyvitamin D (25[OH]D) level at the end of the trial and the incidence of tuberculosis disease, acute respiratory infection, and adverse events', 'incidence of adverse events', 'mean 25(OH)D level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0420176', 'cui_str': 'Vitamin D supplement therapy'}]","[{'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",8851.0,0.752656,"The incidence of adverse events did not differ significantly between the two groups.
","[{'ForeName': 'Davaasambuu', 'Initials': 'D', 'LastName': 'Ganmaa', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Buyanjargal', 'Initials': 'B', 'LastName': 'Uyanga', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Garmaa', 'Initials': 'G', 'LastName': 'Gantsetseg', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Baigali', 'Initials': 'B', 'LastName': 'Delgerekh', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Davaasambuu', 'Initials': 'D', 'LastName': 'Enkhmaa', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Dorjnamjil', 'Initials': 'D', 'LastName': 'Khulan', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Saranjav', 'Initials': 'S', 'LastName': 'Ariunzaya', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Erdenebaatar', 'Initials': 'E', 'LastName': 'Sumiya', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Batbileg', 'Initials': 'B', 'LastName': 'Bolortuya', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Jutmaan', 'Initials': 'J', 'LastName': 'Yanjmaa', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Tserenkhuu', 'Initials': 'T', 'LastName': 'Enkhtsetseg', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Ankhbat', 'Initials': 'A', 'LastName': 'Munkhzaya', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Murneren', 'Initials': 'M', 'LastName': 'Tunsag', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Polyna', 'Initials': 'P', 'LastName': 'Khudyakov', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Seddon', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Marais', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Ochirbat', 'Initials': 'O', 'LastName': 'Batbayar', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Ganbaatar', 'Initials': 'G', 'LastName': 'Erdenetuya', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Bazarsaikhan', 'Initials': 'B', 'LastName': 'Amarsaikhan', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spiegelman', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Jadambaa', 'Initials': 'J', 'LastName': 'Tsolmon', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}, {'ForeName': 'Adrian R', 'Initials': 'AR', 'LastName': 'Martineau', 'Affiliation': ""From the Harvard T.H. Chan School of Public Health (D.G., P.K., D.S.) and the Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School (D.G.) - all in Boston; the Mongolian Health Initiative (D.G., B.U., G.G., D.E., D.K., S.A., E.S., B.B., J.Y., T.E., O.B.) and Global Laboratory (B.D., A.M.), Royal Plaza, Bayanzurkh District, the National Center for Communicable Diseases (M.T.), and the Mongolian National University of Medical Sciences (G.E., B.A., J.T.) - all in Ulaanbaatar, Mongolia; Yale School of Public Health, New Haven, CT (X.Z., D.S.); the Faculty of Medicine, Imperial College (J.A.S.), and the Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London (A.R.M.) - all in London; the Desmond Tutu Tuberculosis Centre, Department of Pediatrics and Child Health, Stellenbosch University, Cape Town, South Africa (J.A.S.); and the Faculty of Medicine and Health, University of Sydney, Sydney (B.J.M.).""}]",The New England journal of medicine,['10.1056/NEJMoa1915176']
1476,32701372,Re: Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.,,2020,,['Frail Patients Undergoing Resection of Colorectal Cancer'],['Multimodal Prehabilitation vs Postoperative Rehabilitation'],['30-Day Postoperative Complications'],"[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C5192101', 'cui_str': 'Prehabilitation'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.10665,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001215.02']
1477,32712806,"Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.","INTRODUCTION


Patients with relapsed or refractory multiple myeloma (RRMM) represent an unmet clinical need. Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class antibody-drug conjugate (ADC; or immunoconjugate) that delivers a cytotoxic payload, monomethyl auristatin F (MMAF), to myeloma cells. In the phase II DREAMM-2 study (NCT03525678), single-agent belamaf (2.5 mg/kg) demonstrated clinically meaningful anti-myeloma activity (overall response rate 32%) in patients with heavily pretreated disease. Microcyst-like epithelial changes (MECs) were common, consistent with reports from other MMAF-containing ADCs.
METHODS


Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected. A literature review on corneal events reported with other ADCs was performed.
RESULTS


In most patients receiving single-agent belamaf (72%; 68/95), MECs were observed by slit lamp microscopy early in treatment (69% had their first event by dose 4). However, IVCM revealed hyperreflective material. Blurred vision (25%) and dry eye (15%) were commonly reported symptoms. Management of MECs included dose delays (47%)/reductions (25%), with few patients discontinuing due to MECs (1%). The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date. A literature review confirmed that similar MECs were reported with other ADCs; however, event management strategies varied. The pathophysiology of MECs is unclear, though the ADC cytotoxic payload may contribute to on- or off-target effects on corneal epithelial cells.
CONCLUSION


Single-agent belamaf represents a new treatment option for patients with RRMM. As with other ADCs, MECs were observed and additional research is warranted to determine their pathophysiology. A multidisciplinary approach, involving close collaboration between eye care professionals and hematologist/oncologists, is needed to determine appropriate diagnosis and management of these patients.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier, NCT03525678.",2020,"The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date.","['patients with heavily pretreated disease', 'patients with RRMM', 'Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin', 'Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected', 'Patients with relapsed or refractory multiple myeloma (RRMM']",[],"['visual acuity', 'Blurred vision', 'clinically meaningful anti-myeloma activity', 'blurred vision', 'Microcyst-like epithelial changes (MECs', 'MECs', 'permanent vision loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C0438105', 'cui_str': 'Examination finding'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",[],"[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",,0.0423515,"The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date.","[{'ForeName': 'Asim V', 'Initials': 'AV', 'LastName': 'Farooq', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA. afarooq@bsd.uchicago.edu.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Degli Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Praneetha', 'Initials': 'P', 'LastName': 'Thulasi', 'Affiliation': 'Emory Eye Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Zaugg', 'Affiliation': 'Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ashraf Z', 'Initials': 'AZ', 'LastName': 'Badros', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Colby', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00280-8']
1478,32712884,Impact of IL28B gene polymorphism on efficacy and safety of direct acting antivirals in hepatitis C Egyptian patients.,"Background Hepatitis C virus infection is one of the major causes of liver cirrhosis and hepatocellular carcinoma worldwide. IL28B gene polymorphism has a direct relation to the response of interferon-based regimens. However, the effect of IL28B gene polymorphism on efficacy of the new direct acting antivirals used in treatment of chronic hepatitis C Egyptian patients hasn't been studied yet. Objective This study aimed to investigate the frequency of IL28B genotypes and impact of its polymorphism on the efficacy and safety of two direct acting antiviral regimens. Setting Patients were recruited form faculty of Medicine Ain shams research institute, Cairo, Egypt. Methods Easy to treat chronic hepatitis C Egyptian patients were included in this prospective study. Patients were randomized into two groups, group 1 received sofosbuvir plus daclatasvir and group 2 received paritaprevir, ombitasvir and ritonavir plus ribavirin. Both treatment regimens were given for 3 months. Laboratory evaluation and IL28B rs 12979860 genotyping were performed at baseline. Follow ups were performed monthly. Fibrosis was assessed at baseline and after treatment. Main outcome measures The frequency of IL28B genotypes and their correlation with safety and efficacy of direct acting antiviral regimens. Results CT genotype was present in 52.42% of patients while CC and TT genotypes were present in 28.16% and 19.42% of patients, respectively. IL28B genotypes weren't correlated to sustained virologic response in both treatment groups. Baseline fibroscan scores didn't show any significant relations with IL28B genotypes. Aspartate aminotransferase/alanine aminotransferase ratio increased significantly at the end of treatment in group1. CC genotype had shown higher ratio values at the end of treatment in Group 2. Conclusion CT genotype is the predominant genotype in easy to treat HCV Egyptian patients. IL28B genotypes hasn't any predictive value on the efficacy or the safety of direct acting antiviral regimens.",2020,Aspartate aminotransferase/alanine aminotransferase ratio increased significantly at the end of treatment in group1.,"['Setting Patients were recruited form faculty of Medicine Ain shams research institute, Cairo, Egypt', 'chronic hepatitis C Egyptian patients', 'hepatitis C Egyptian patients']","['IL28B gene polymorphism', 'sofosbuvir plus daclatasvir and group 2 received paritaprevir, ombitasvir and ritonavir plus ribavirin']","['ratio values', 'Fibrosis', 'Baseline fibroscan scores', 'Aspartate aminotransferase/alanine aminotransferase ratio', 'efficacy and safety', 'sustained virologic response', 'frequency of IL28B genotypes and their correlation with safety and efficacy of direct acting antiviral regimens']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0347129', 'cui_str': 'Dysplasia of anus'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0035172', 'cui_str': 'Research Institutes'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C3864824', 'cui_str': 'paritaprevir'}, {'cui': 'C3852670', 'cui_str': 'ombitasvir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}]","[{'cui': 'C1532109', 'cui_str': 'Ratio value'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",,0.0270569,Aspartate aminotransferase/alanine aminotransferase ratio increased significantly at the end of treatment in group1.,"[{'ForeName': 'Abdel-Hameed Ibrahim Mohamed', 'Initials': 'AIM', 'LastName': 'Ebid', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmacy, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Sara Hassan', 'Initials': 'SH', 'LastName': 'Agwa', 'Affiliation': 'Department of Clinical and Chemical Pathology at MASRI, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Sara Mohamed', 'Initials': 'SM', 'LastName': 'Abdel-Motaleb', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmacy, Helwan University, Cairo, Egypt.'}, {'ForeName': 'Radwa Samir', 'Initials': 'RS', 'LastName': 'Hagag', 'Affiliation': 'Department of Pharmacy Practice, Faculty of Pharmacy, Egyptian Russian University, Badr City, Egypt. Radwahagag@yahoo.com.'}]",International journal of clinical pharmacy,['10.1007/s11096-020-01085-2']
1479,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1480,32722729,"NSI-189 phosphate, a novel neurogenic compound, selectively benefits moderately depressed patients: A post-hoc analysis of a phase 2 study of major depressive disorder.","BACKGROUND


NSI-189 phosphate (NSI-189) is a novel neurogenic molecule with pleiotropic properties, including antidepressant, procognitive, synaptoplastic, and neurotrophic activities demonstrated in preclinical studies. Its antidepressant activity is monoamine-independent. NSI-189 was previously tested in patients with recurrent major depressive disorder in an inpatient setting.
METHODS


This study involved 220 patients randomized to an NSI-189 40-mg dose, NSI-189 80-mg dose, or placebo daily for 12 weeks. The study utilized the sequential parallel comparison design, in which the drug effect was tested in 2 separate stages of 6 weeks each. Herein, post-hoc analyses of the data are presented.
RESULTS


NSI-189's antidepressant effect increased when the participants' initial baseline depression severity was dichotomized along a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 30. The NSI-189 80-mg dose showed significant benefit over placebo when utilizing the MADRS-6 (P = .046) in the subgroup of patients who were moderately depressed (MADRS < 30) but was not significant in patients who were severely depressed (MADRS ≥30). More pronounced procognitive effects were also observed in the moderate subgroup relative to the severe subgroup or the whole study group, in which 11/36 (31%), 5/36 (14%), or 7/36 (19%) of CogScreen variables significantly improved, respectively.
CONCLUSIONS


These results suggest that NSI-189 is effective as a safe adjunctive therapy, with most compelling antidepressant and procognitive benefits noted in patients with moderate depression.",2020,The NSI-189 80-mg dose showed significant benefit over placebo when utilizing the MADRS-6 (P = .046) in the subgroup of patients who were moderately depressed (MADRS < 30) but was not significant in patients who were severely depressed (MADRS ≥30).,"['220 patients randomized to an', 'patients with recurrent major depressive disorder in an inpatient setting', 'patients with moderate depression']","['NSI-189 40-mg dose, NSI-189 80-mg dose, or placebo', 'NSI-189 phosphate (NSI-189', 'NSI-189 phosphate', 'NSI-189', 'placebo']","['Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'procognitive effects', 'initial baseline depression severity']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}]","[{'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",220.0,0.0867314,The NSI-189 80-mg dose showed significant benefit over placebo when utilizing the MADRS-6 (P = .046) in the subgroup of patients who were moderately depressed (MADRS < 30) but was not significant in patients who were severely depressed (MADRS ≥30).,"[{'ForeName': 'Karl K', 'Initials': 'KK', 'LastName': 'Johe', 'Affiliation': ''}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': ''}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ''}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Burdick', 'Affiliation': ''}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': ''}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
1481,32726308,Improved patient satisfaction and diagnostic accuracy in skin diseases with a Visual Clinical Decision Support System-A feasibility study with general practitioners.,"Patient satisfaction is an important indicator of health care quality, and it remains an important goal for optimal treatment outcomes to reduce the level of misdiagnoses and inappropriate or absent therapeutic actions. Digital support tools for differential diagnosis to assist clinicians in reaching the correct diagnosis may be helpful, but how the use of these affect patients is not clear. The primary objective of this feasibility study was to investigate patient experience and satisfaction in a primary care setting where general practitioners (GPs) used a visual clinical decision support system (CDSS) compared with standard consultations. Secondary objectives were diagnostic accuracy and length of consultation. Thirty-one patients with a dermatologist-confirmed skin diagnosis were allocated to consult GPs that had been randomized to conduct either standard consultations (SDR, n = 21) or CDSS (n = 16) on two separate study days one week apart. All patients were diagnosed independently by multiple GPs (n = 3-8) in both the SDR and CDSS study arms. Using the CDSS, more patients felt involved in the decision making (P = 0.05). In addition, more patients were exposed to images during the consultations (P = 6.8e-27), and 83% of those that were shown images replied they felt better supported in the consultation. The use of CDSS significantly improved the diagnostic accuracy (34%, P = 0.007), and did not increase the duration of the consultation (median 10 minutes in both arms). This study shows for the first time that compared with standard GP consultations, CDSS assist the GP on skin related diagnoses and improve patient satisfaction and diagnostic accuracy without impacting the duration of the consultations. This is likely to increase correct treatment choices, patient adherence, and overall result in better healthcare outcomes.",2020,"The use of CDSS significantly improved the diagnostic accuracy (34%, P = 0.007), and did not increase the duration of the consultation (median 10 minutes in both arms).","['Thirty-one patients with a dermatologist-confirmed skin diagnosis', 'general practitioners']","['CDSS', 'visual clinical decision support system (CDSS']","['patient satisfaction and diagnostic accuracy', 'diagnostic accuracy', 'duration of the consultation', 'diagnostic accuracy and length of consultation']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",31.0,0.0505547,"The use of CDSS significantly improved the diagnostic accuracy (34%, P = 0.007), and did not increase the duration of the consultation (median 10 minutes in both arms).","[{'ForeName': 'Eckhard W', 'Initials': 'EW', 'LastName': 'Breitbart', 'Affiliation': 'Association of Dermatological Prevention (ADP), Hamburg, Germany.'}, {'ForeName': 'Kohelia', 'Initials': 'K', 'LastName': 'Choudhury', 'Affiliation': 'Association of Dermatological Prevention (ADP), Hamburg, Germany.'}, {'ForeName': 'Anders Daniel', 'Initials': 'AD', 'LastName': 'Andersen', 'Affiliation': 'LEO Innovation Lab, Copenhagen, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Bunde', 'Affiliation': 'Association of Dermatological Prevention (ADP), Hamburg, Germany.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Breitbart', 'Affiliation': 'Association of Dermatological Prevention (ADP), Hamburg, Germany.'}, {'ForeName': 'Antonia Maria', 'Initials': 'AM', 'LastName': 'Sideri', 'Affiliation': 'LEO Innovation Lab, Copenhagen, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Fengler', 'Affiliation': 'Association of Dermatological Prevention (ADP), Hamburg, Germany.'}, {'ForeName': 'John Robert', 'Initials': 'JR', 'LastName': 'Zibert', 'Affiliation': 'LEO Innovation Lab, Copenhagen, Denmark.'}]",PloS one,['10.1371/journal.pone.0235410']
1482,32738408,Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.,"For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.",2020,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"['diverse patients attending HIV primary care clinics', 'Eligible and consenting patients from four HIV primary care clinical sites', 'people with HIV in health care', 'patients seen in HIV primary care']",['Positive Health Check intervention in addition to the standard of care or the standard of care only'],['HIV viral loads'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",4.0,0.0882936,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America. Electronic address: melewis@rti.org.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Harshbarger', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burrus', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Peinado', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Khavjou', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Karns', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Zulkiewicz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Galindo', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DallaPiazza', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Holm', 'Affiliation': 'NO AIDS Task Force dba CrescentCare, New Orleans, LA, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Emory Vaccine Center, and Rollins School of Public Health, Atlanta, GA, United States of America; Atlanta VA Medical Center, Decatur, GA, United States of America.'}, {'ForeName': 'Charurut', 'Initials': 'C', 'LastName': 'Somboonwit', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Tampa, FL, United States of America.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106097']
1483,32738409,Acute effects of adaptive Deep Brain Stimulation in Parkinson's disease.,"BACKGROUND


Beta-based adaptive Deep Brain Stimulation (aDBS) is effective in Parkinson's disease (PD), when assessed in the immediate post-implantation phase. However, the potential benefits of aDBS in patients with electrodes chronically implanted, in whom changes due to the microlesion effect have disappeared, are yet to be assessed.
METHODS


To determine the acute effectiveness and side-effect profile of aDBS in PD compared to conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation, 13 PD patients undergoing battery replacement were pseudo-randomised in a crossover fashion, into three conditions (NoStim, aDBS or cDBS), with a 2-min interval between them. Patient videos were blindly evaluated using a short version of the Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT).
RESULTS


Mean disease duration was 16 years, and the mean time since DBS-implantation was 6.9 years. subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p = .001), when compared to NoStim. Bradykinesia subscores were significantly lower in aDBS (p = .002), and did not achieve significance during cDBS (p = .08), when compared to NoStim. Two patients demonstrated re-emerging tremor during aDBS. SIT scores of patients who presented stimulation-induced dysarthria significantly worsened in cDBS (p = .009), but not in aDBS (p = .407), when compared to NoStim. Overall, stimulation was applied 48.8% of the time during aDBS.
CONCLUSION


Beta-based aDBS is effective in PD patients with bradykinetic phenotypes, delivers less stimulation than cDBS, and potentially has a more favourable speech side-effect profile. Patients with prominent tremor may require a modified adaptive strategy.",2020,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[""Parkinson's disease"", 'PD patients with bradykinetic phenotypes', '13 PD patients undergoing battery replacement', 'Patients with prominent tremor', ""Parkinson's disease (PD""]","['aDBS', 'Adaptive Deep Brain Stimulation', 'Beta-based aDBS', 'Beta-based adaptive Deep Brain Stimulation (aDBS', 'conventional continuous DBS (cDBS) and no stimulation (NoStim), years after DBS implantation']","['Mean disease duration', 'subUPDRS scores', 'SIT scores', ""Unified Parkinson's Disease Rating Scale (subUPDRS), and the Speech Intelligibility Test (SIT"", 'mean time since DBS-implantation', 'Bradykinesia subscores']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0445093', 'cui_str': 'No stimulation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}]",,0.0348207,"subUPDRS scores (11 patients tested) were significantly lower both in aDBS (p=<.001), and cDBS (p=.001), when compared to NoStim.","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Piña-Fuentes', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands; Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom; Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'J Marc C', 'Initials': 'JMC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'van Zijl', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Harmen R', 'Initials': 'HR', 'LastName': 'Moes', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'Teus', 'Initials': 'T', 'LastName': 'van Laar', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans.'}, {'ForeName': 'D L Marinus', 'Initials': 'DLM', 'LastName': 'Oterdoom', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Little', 'Affiliation': 'Department of Movement Disorders and Neuromodulation, University of California San Francisco, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Medical Research Council Brain Network Dynamics Unit at the University of Oxford, United Kingdom; Nuffield Department of Clinical Neurosciences, University of Oxford, United Kingdom.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Beudel', 'Affiliation': 'Department of Neurology, Amsterdam Neuroscience Institute, Amsterdam University Medical Center, Amsterdam, The Netherlans. Electronic address: m.beudel@amsterdamumc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.07.016']
1484,32738416,"Afatinib in patients with advanced non-small cell lung cancer harboring HER2 mutations, previously treated with chemotherapy: A phase II trial.","BACKGROUND


Despite 1-4 % of NSCLC tumors harboring mutations in the HER2 gene, there are no approved HER2-pathway-targeted treatments available. We report an open-label, single-arm, multicenter phase II study investigating the efficacy and safety of afatinib in Asian patients with HER2-mutation positive (HER2m+) NSCLC.
METHODS


Eligible patients for Part A had confirmed stage IIIb/IV HER2m + NSCLC, had failed one or two prior lines of chemotherapy, and were EGFR/HER2-inhibitor naïve. Patients received oral afatinib 40 mg/day in continuous 28-day cycles, until disease progression or intolerable adverse events (AEs). Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2. In Part B, patients were to receive afatinib at the last received dose, plus paclitaxel 80 mg/m 2  weekly, until disease progression or intolerable AEs. The primary endpoint in Part A was objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS). Further exploratory endpoints were OR, DC, and PFS in Part B.
RESULTS


Eighteen patients received afatinib in Part A. No patient achieved an OR; 11 patients (61.1 %) achieved stable disease, and six patients (33.3 %) had progressive disease. DC rate was therefore 61.1 % (95 % confidence interval [CI]: 35.7, 82.7). A decrease in tumor size from baseline of > 0 to < 30 % was observed in eight patients. At the time of analysis, 16 patients (88.9 %) had progressed or died. Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08). All patients experienced ≥ 1 AE, most commonly diarrhea (66.7 %) and rash (33.3 %). No patients met the inclusion criteria for Part B, and recruitment was slow; therefore, the study was terminated.
CONCLUSIONS


This study found no clinical benefit of afatinib for EGFR TKI-naïve patients with HER2m + NSCLC.",2020,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","['Eighteen patients received afatinib in Part A', ""Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2"", 'EGFR TKI-naïve patients with HER2m\u202f+\u202fNSCLC', 'Asian patients with HER2-mutation positive (HER2m+) NSCLC', 'Eligible patients for Part A had confirmed stage IIIb/IV HER2m', 'patients with advanced non-small cell lung cancer harboring HER2 mutations']","['Afatinib', 'oral afatinib', 'plus paclitaxel 80\u202fmg/m 2  weekly, until disease progression or intolerable AEs', 'chemotherapy', 'afatinib']","['OR, DC, and PFS in Part B', 'diarrhea', 'DC rate', 'progressive disease', 'Median PFS', 'median OS', 'objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS', 'progressed or died', 'efficacy and safety', 'tumor size', 'stable disease', 'rash']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.160329,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'The First Affiliated Hospital with Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Dennis Chin-Lun', 'Initials': 'DC', 'LastName': 'Huang', 'Affiliation': 'Boehringer Ingelheim Taiwan Limited, Taipei, Taiwan.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China. Electronic address: caicunzhoudr@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.07.017']
1485,32705417,High-dose rocuronium-induced paralysis of the adductor pollicis muscle facilitates detection of the timing for tracheal intubation in elderly patients: a randomized double-blind study.,"PURPOSE


To prevent coughing related to tracheal intubation and the resultant exposure of intubating staff to the patients' expiratory aerosols, the timing of tracheal intubation needs to be precisely predicted. The aim of this study was to evaluate the hypothesis that the timing for safe tracheal intubation in elderly patients can be determined by acceleromyographically monitoring paralysis of the adductor pollicis muscle when high-dose rocuronium, given to block the respiratory muscles, is administered.
METHODS


Forty elderly (65-92 years) patients were enrolled in this study and randomly assigned to two groups, to receive rocuronium 0.6 mg/kg or 1 mg/kg. After induction of anesthesia and observing acceleromyographic train-of-four (TOF) responses of the adductor pollicis muscle to ulnar nerve stimulation, the patients randomly received either dose of rocuronium. The onset times from rocuronium administration to TOF counts of 0 were measured. Soon thereafter, a single anesthesiologist who was blinded to the allocated dose of rocuronium performed laryngoscopy and tracheal intubation, and assessed intubating conditions. Data were analyzed by the unpaired t-test and Chi-squared test.
RESULTS


The averaged [SD] onset time of neuromuscular blockade was significantly shorter with 1 mg/kg than 0.6 mg/kg rocuronium (104.3 [30.1] s vs. 186.8 [37.5] s, p < 0.001). Patients who received 0.6 mg/kg rocuronium variously showed either poor (n = 9) or good (n = 11) intubating conditions. However, all patients who received 1 mg/kg rocuronium had excellent intubating conditions.
CONCLUSIONS


If 1 mg/kg rocuronium is administered, a TOF count of 0 acceleromyographically observed at the adductor pollicis muscle can reveal the adequate timing for tracheal intubation.",2020,The averaged [SD] onset time of neuromuscular blockade was significantly shorter with 1 mg/kg than 0.6 mg/kg rocuronium (104.3 [30.1] s vs. 186.8,"['Forty elderly (65-92\xa0years', 'elderly patients']","['rocuronium', 'anesthesia and observing acceleromyographic train-of-four (TOF', 'rocuronium 0.6\xa0mg/kg or 1\xa0mg/kg', 'rocuronium performed laryngoscopy and tracheal intubation, and assessed intubating conditions']","['averaged [SD] onset time of neuromuscular blockade', 'excellent intubating conditions']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",40.0,0.550908,The averaged [SD] onset time of neuromuscular blockade was significantly shorter with 1 mg/kg than 0.6 mg/kg rocuronium (104.3 [30.1] s vs. 186.8,"[{'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Takagi', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Sugaya', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Iwasa', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Masumi', 'Initials': 'M', 'LastName': 'Itagaki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Seki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine, 30-1, Oyaguchi-Kamicho, Itabashi-Ku, Tokyo, 173-8610, Japan. suzuki.takahiro@nihon-u.ac.jp.'}]",Journal of anesthesia,['10.1007/s00540-020-02831-6']
1486,32716241,"Re: Prostate-Specific Membrane Antigen PET-CT in Patients with High-Risk Prostate Cancer before Curative-Intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multicentre Study.",,2020,,['Patients with High-Risk Prostate Cancer before Curative-Intent Surgery or Radiotherapy (proPSMA'],['Re: Prostate-Specific Membrane Antigen PET-CT'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0402414,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001220.01']
1487,32716270,Re: Prospective Randomized Trial Comparing the Safety and Clarity of Water versus Saline Irrigant in Ureteroscopy.,,2020,,[],['Water versus Saline Irrigant'],[],[],"[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}]",[],,0.0542995,,"[{'ForeName': 'Dean G', 'Initials': 'DG', 'LastName': 'Assimos', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001217.04']
1488,32717350,A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.,"College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive intervention (API) to reduce high-risk drinking among first-year college students. The API is designed to educate students and to motivate heavy-drinking college students to engage in existing resources to support reducing high-risk alcohol use, by leveraging technology-based intervention modalities. The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization. Adaptive preventive interventions have the potential to reduce the acute and long-term negative health consequences of young adult alcohol use.",2020,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","['college student drinking reduction', 'first-year college students']",['adaptive preventive intervention (API'],"['reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization']","[{'cui': 'C4042862', 'cui_str': 'Alcohol Drinking, College Students'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.0187936,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Boatman', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Morrell', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Wagner', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Grace R', 'Initials': 'GR', 'LastName': 'Lyden', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, 2800 Plymouth Road, NCRC Building 10, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Vock', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106089']
1489,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
1490,32719355,Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma.,"Glucocorticoids (GC) are a controversial yet commonly used intervention in the clinical management of acute inflammatory conditions, including sepsis or traumatic injury. In the context of major trauma such as surgery, concerns have been raised regarding adverse effects from GC, thereby necessitating a better understanding of how GCs modulate the immune response. Here we report the results of a randomized controlled trial (NCT02542592) in which we employ a high-dimensional mass cytometry approach to characterize innate and adaptive cell signaling dynamics after a major surgery (primary outcome) in patients treated with placebo or methylprednisolone (MP). A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments. By contrast, key innate signaling responses previously associated with pain and functional recovery after surgery, including STAT3 and CREB phosphorylation, are not affected by MP. These results imply cell-specific and pathway-specific effects of GCs, and also prompt future studies to examine GCs' effects on clinical outcomes likely dependent on functional adaptive immune responses.",2020,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","['patients treated with', 'patients after acute surgical trauma']","['Glucocorticoids (GC', 'placebo or methylprednisolone (MP', 'glucocorticoids']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]",[],,0.170748,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","[{'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Ganio', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Stanley', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Lindberg-Larsen', 'Affiliation': 'The Lundbeck Foundation Center for Fast-track Hip and Knee replacement, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Einhaus', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Verdonk', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Culos', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ghaemi', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Rumer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ina A', 'Initials': 'IA', 'LastName': 'Stelzer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dyani', 'Initials': 'D', 'LastName': 'Gaudilliere', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Choisy', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology 7621, Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Aghaeepour', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Angst', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Gaudilliere', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA. gbrice@stanford.edu.'}]",Nature communications,['10.1038/s41467-020-17565-y']
1491,32729405,Acute Stress Improves Concentration Performance.,"Acute stress can have both detrimental and beneficial effects on cognitive processing, but effects on concentration performance remain unclear. Here, we investigate the effects of acute psychosocial stress on concentration performance and possible underlying physiological and psychological mechanisms. The study sample comprised 47 healthy male participants who were randomly assigned either to a psychosocial stress situation (Trier Social Stress Test) or a neutral control task. Concentration performance was assessed using the d2 Test of Attention before and 30 min after the stress or control task. Salivary cortisol and alpha-amylase were repeatedly measured before and up to 1 hr after stress. We repeatedly assessed state anxiety using the State-Trait Anxiety Inventory and anticipatory cognitive stress appraisal using the Primary Appraisal Secondary Appraisal questionnaire. The stress group showed a significantly stronger improvement of concentration performance compared to the control group ( p  = .042). Concentration performance improvement was predicted by increased state anxiety ( p  = .020) and lower cortisol (stress) changes ( p  = .043). Neither changes in alpha-amylase nor cognitive stress appraisal did relate to concentration performance. Our results show improved concentration performance after acute psychosocial stress induction that was predicted by higher state anxiety increases and lower cortisol increases. This points to a potential modulating role of specific psycho-emotional and physiological factors with opposite effects.",2020,The stress group showed a significantly stronger improvement of concentration performance compared to the control group ( p  = .042).,['47 healthy male participants'],['psychosocial stress situation (Trier Social Stress Test) or a neutral control task'],"['Salivary cortisol and alpha-amylase', 'state anxiety increases and lower cortisol increases', 'Concentration performance improvement', 'state anxiety using the State-Trait Anxiety Inventory and anticipatory cognitive stress appraisal', 'state anxiety', 'Concentration Performance', 'lower cortisol (stress) changes', 'concentration performance', 'Concentration performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",47.0,0.0253662,The stress group showed a significantly stronger improvement of concentration performance compared to the control group ( p  = .042).,"[{'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Degroote', 'Affiliation': 'Biological Work and Health Psychology, Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Schwaninger', 'Affiliation': 'School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland (FHNW), Olten, Switzerland.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Heimgartner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Patrik', 'Initials': 'P', 'LastName': 'Hedinger', 'Affiliation': 'Clienia Littenheid AG, Private Hospital for Psychiatric and Psychotherapy, Littenheid, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Ehlert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Petra H', 'Initials': 'PH', 'LastName': 'Wirtz', 'Affiliation': 'Biological Work and Health Psychology, Department of Psychology, University of Konstanz, Konstanz, Germany.'}]",Experimental psychology,['10.1027/1618-3169/a000481']
1492,32729407,The Opposite of Stress.,"Cognition is affected by psychophysiological states. While the influence of stress on cognition has been investigated intensively, less studies have addressed how the opposite of stress, a state of relaxation, affects cognition. We investigated whether the extent of parasympathetic activation is positively related to divergent thinking. Sixty healthy female participants were randomly allocated to a standardized vagus nerve massage ( n  = 19), a standardized soft shoulder massage ( n  = 22), or a resting control group ( n  = 19). Subsequently, participants completed the Alternative Uses Test (AUT), a measure of divergent thinking. Respiratory sinus arrhythmia (RSA), a vagally mediated heart rate variability component, was monitored throughout the experiment. The area under the curve with respect to the increase was calculated for RSA trajectories as an indicator of vagal tone during the relaxing intervention. Regressions tested the effect of vagal tone on AUT outcomes. We found an association between vagal tone and subsequent AUT outcomes. Yet, this association was no longer significant when controlling for the effect of the creative potential of an individual, which was strongly related to AUT outcomes. Being exploratory, we found a positive association between creative potential and vagal tone. These results imply that creative potential might be related to the capacity to relax.",2020,"Yet, this association was no longer significant when controlling for the effect of the creative potential of an individual, which was strongly related to AUT outcomes.",['Sixty healthy female participants'],"['standardized soft shoulder massage', 'standardized vagus nerve massage']",['Respiratory sinus arrhythmia (RSA'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0042276', 'cui_str': 'Vagus nerve structure'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}]",60.0,0.0189613,"Yet, this association was no longer significant when controlling for the effect of the creative potential of an individual, which was strongly related to AUT outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Unternaehrer', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Sabine M', 'Initials': 'SM', 'LastName': 'Schorpp', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Benz', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Ulrike U', 'Initials': 'UU', 'LastName': 'Bentele', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Dimitroff', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Denk', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Prüssner', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Konstanz, Konstanz, Germany.'}]",Experimental psychology,['10.1027/1618-3169/a000483']
1493,32726666,Intermittent theta burst stimulation over the dorsomedial prefrontal cortex modulates resting-state connectivity in depressive patients: A sham-controlled study.,"The mechanisms underlying repetitive transcranial magnetic stimulation (rTMS) treatment are largely unknown. Although there is a general lack of sham controlled studies, findings show altered functional connectivity to the stimulated region following treatment. When targeting the dorsolateral prefrontal cortex (dlPFC), connectivity with the subgenual anterior cingulate cortex (sgACC) is predictive of response, but less is known about the effects on functional connectivity of targeting the dorsomedial PFC (dmPFC). Here, 30 patients with an ongoing depressive episode were recruited and randomized to 20 sessions at target intensity of either active or sham intermittent theta burst stimulation (iTBS) over dmPFC. Those receiving sham were offered active treatment in a subsequent open phase. A seven minute resting-state scan and depressive symptom assessment was performed before and after treatment. After exclusions due to attrition and excessive head movements 23 patients remained for analysis. Seed-based resting-state connectivity was calculated using two seeds for the dmPFC target as well as the sgACC. A symptom related increase in dmPFC connectivity after active treatment, compared to sham treatment, was found. The effect was observed in a region overlapping the precuneus and the posterior cingulate cortex (PCC), suggesting an increase in the connectivity between the targeted salience network and the default mode network mediating improvement in depressive symptoms. Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment. The findings have implications for understanding the mechanisms behind iTBS and may inform future efforts to individualize the treatment.",2020,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"['30 patients with an ongoing depressive episode', 'depressive patients']","['repetitive transcranial magnetic stimulation (rTMS', 'Intermittent theta burst stimulation', 'active or sham intermittent theta burst stimulation (iTBS) over dmPFC']",['dmPFC connectivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",30.0,0.0349908,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden. Electronic address: jonas.persson@neuro.uu.se.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden; Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fällmar', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112834']
1494,32734722,"Efficacy of additional tunica vaginalis flap coverage for protecting against urethrocutaneous fistulas in tubularized incised plate urethroplasty: A prospective, randomized controlled trial.","PURPOSE


We compared the protective effect of additional tunica vaginalis flap coverage combined with a dartos flap against urethrocutaneous fistulas in tubularized incised plate (TIP) urethroplasty in a randomized controlled trial.
MATERIALS AND METHODS


This prospective, randomized controlled trial in a single tertiary center enrolled 50 patients in whom it was feasible to perform single TIP urethroplasty between 2016 and 2017. Consecutive children were randomly allocated to study group A (additional tunica vaginalis flap coverage, n=25) or control group B (dartos-only coverage, n=25). All patients were examined in the outpatient clinic at 1, 3, 12, and 24 months. Postoperative cosmetic outcomes were evaluated by surgeons and parents using the Pediatric Penile Perception Scale questionnaire.
RESULTS


In group B, 1 of 25 patients (4.0%) developed an urethrocutaneous fistula within 12 months. An additional two cases of fistula were found in all proximal-type hypospadias patients at 24 months in the same group without statistical significance (p=0.07). The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale.
CONCLUSIONS


Our randomized controlled trial did not show a significant decrease in the incidence of or a significant slowing of the progression of postoperative fistulas after TIP urethroplasty by the use of additional tunica vaginalis coverage. A tunica vaginalis flap is not routinely recommended but could have a selective role in proximal-type TIP urethroplasty with deficient dartos and subcutaneous tissue to cover the neourethra.",2020,"The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale.
","['tubularized incised plate urethroplasty', 'Consecutive children', 'single tertiary center enrolled 50 patients in whom it was feasible to perform single TIP urethroplasty between 2016 and 2017']","['additional tunica vaginalis flap coverage combined with a dartos flap against urethrocutaneous fistulas', 'additional tunica vaginalis flap coverage']","['Pediatric Penile Perception Scale', 'Postoperative cosmetic outcomes', 'penile cosmetic satisfaction rate', 'urethrocutaneous fistula', 'Pediatric Penile Perception Scale questionnaire']","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0228014', 'cui_str': 'Tunica vaginalis structure'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0689132,"The penile cosmetic satisfaction rate was not significantly different between the groups according to scores on the Pediatric Penile Perception Scale.
","[{'ForeName': 'Jae Hyeon', 'Initials': 'JH', 'LastName': 'Han', 'Affiliation': 'Department of Urology, Korea University Ansan Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Song', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Je Seong', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, VA, USA.'}, {'ForeName': 'Sungchan', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Urology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.'}, {'ForeName': 'Sung Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Kun Suk', 'Initials': 'KS', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. kskim2@amc.seoul.kr.'}]",Investigative and clinical urology,['10.4111/icu.20200024']
1495,32731011,The effect of Hatha yoga intervention on students' creative ability.,"There is increasing demand for individual creativity as organizations seek innovative ways to remain relevant. Higher education institutions, particularly business schools, are sensitive to this demand and are constantly in search for innovative ways to enhance the creative ability of their students. Prior studies have shown encouraging results for physical activity-oriented interventions. Building on this research, this study uses Randomized Controlled Trial (RCT) to understand if an acute combinatory intervention, involving both physical and mental exercises embodied in Hatha yoga can improve individual creativity. This study uses 92 MBA student participants to investigate the impact of a 20-minute Hatha yoga session intervention against a short 20-minute case study session for the control group. Creative ability of the participants is operationalized through divergent and convergent thinking, which are then assessed through counter-balanced forms of Guilford Alternate Uses tasks and Remote Associate Test, respectively. The results show that while Hatha yoga significantly improves divergent thinking, the control group shows deterioration in divergent thinking. There is no effect on convergent thinking. These findings lend some support to the executive function hypothesis. The study also finds that prodding a person to be more creative on a routine academic task may not enhance their creative ability.",2020,There is no effect on convergent thinking.,"['92 MBA student participants', ""students' creative ability""]",['Hatha yoga intervention'],"['divergent thinking', 'individual creativity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",92.0,0.0286741,There is no effect on convergent thinking.,"[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bollimbala', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India; T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: ashish@tapmi.edu.in.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'James', 'Affiliation': 'IFIM Business School, Bangalore, Karnataka, India.'}, {'ForeName': 'Shirshendu', 'Initials': 'S', 'LastName': 'Ganguli', 'Affiliation': 'T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: shirshenduganguli@tapmi.edu.in.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103121']
1496,32744354,Consistent effects of empagliflozin on cardiovascular and kidney outcomes irrespective of diabetic kidney disease categories: Insights from the EMPA-REG OUTCOME trial.,"AIM


To explore the cardiovascular (CV) and kidney effects of empagliflozin in patients with different clinical phenotypes of diabetic kidney disease (DKD) (i.e. with the presence or absence of overt albuminuria) participating in the EMPA-REG OUTCOME trial.
MATERIALS AND METHODS


EMPA-REG OUTCOME randomized participants (1:1:1) to empagliflozin 10 mg, 25 mg or placebo, added to standard of care. Post hoc, patients with different clinical phenotypes of DKD at baseline were categorized in three subgroups: (a) overt DKD (overt albuminuria [urinary albumin-to-creatinine ratio of >300 mg/g] with any estimated glomerular filtration rate [eGFR]; n = 769); (b) non-overt DKD (kidney impairment [eGFR < 60 mL/min/1.73 m 2  ] without overt albuminuria [urinary albumin-to-creatinine ratio of ≤300 mg/g]; n = 1290); and (c) 'all others' (eGFR ≥ 60 mL/min/1.73 m 2  without overt albuminuria; n = 4893). Analyses included CV (death, hospitalization for heart failure, all-cause hospitalization) and selected kidney outcomes, change in eGFR and kidney safety. Cox proportional hazards models assessed the consistency of treatment effect across subgroups.
RESULTS


Empagliflozin significantly reduced the risk of CV and kidney outcomes across all subgroups (P-values for interaction >.05), consistent with the overall trial population findings. Empagliflozin also significantly reduced the yearly loss of eGFR, assessed by chronic slopes, in all subgroups. The adverse event profile of empagliflozin was similar across all subgroups.
CONCLUSIONS


Empagliflozin may improve CV and kidney outcomes and slow the progression of kidney disease in type 2 diabetes patients with DKD, irrespective of its clinical form, both with or without the presence of overt albuminuria.",2020,"RESULTS


Empagliflozin significantly reduced risk of CV and kidney outcomes across all subgroups (P-values for interaction >0.05), consistent with the overall trial population findings.","['patients with DKD', ""patients with different clinical phenotypes of DKD at baseline were categorized in three subgroups: 1) overt DKD (overt albuminuria [UACR >300 mg/g] with any eGFR; n\xa0=\xa0769); 2) non-overt DKD (kidney impairment [eGFR <60 ml/min/1.73m 2  ] without overt albuminuria [UACR ≤300mg/g]; n\xa0=\xa01290); 3) 'all others' (eGFR ≥60 ml/min/1.73m 2  without overt albuminuria; n\xa0=\xa04893"", 'type 2 diabetes patients with DKD']","['Empagliflozin', 'empagliflozin', 'empagliflozin 10mg, 25mg or placebo']","['CV and kidney outcomes and slow progression of kidney disease', 'yearly loss of eGFR', 'cardiovascular (CV; death, hospitalization for heart failure, all-cause hospitalization) and selected kidney outcomes, change in eGFR and kidney safety', 'risk of CV and kidney outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.149974,"RESULTS


Empagliflozin significantly reduced risk of CV and kidney outcomes across all subgroups (P-values for interaction >0.05), consistent with the overall trial population findings.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Division of Nephrology, Wuerzburg University Clinic, Wuerzburg, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Department of Medicine, Division of Nephrology, Wuerzburg University Clinic, Wuerzburg, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Sibylle J', 'Initials': 'SJ', 'LastName': 'Hauske', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14158']
1497,32739495,Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis.,"BACKGROUND/AIMS


Despite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH.
METHODS


Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score ≥ 20 stratified by MELD scores (20-25 and ≥ 26) and randomized to a combination of an interleukin receptor 1 antagonist, Anakinra(100 mg daily for 14 days) to suppress acute inflammation, pentoxifylline (400 mg three times a day for 28 days) to prevent hepatorenal syndrome, and zinc sulfate (220 mg orally once daily for 6 months) or the standard of care therapy including methylprednisolone 32 mg orally once daily for 28 days. The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
RESULTS


Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6 ± 3.2 (20.0-35.0) in the investigational arm and 25.8 ± 4.5 (20.0-40.0) in the standard of care arm. Causes of screen failures included not meeting eligibility criteria (n = 347), declining to participate (n = 39), and other reasons (n = 10).
CONCLUSIONS


Data from the DASH consortium studies will determine if a combination of drugs targeting multiple mechanisms of injury in the severe AH will improve clinical outcomes.",2020,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","['Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6\u202f±\u202f3.2 (20.0-35.0) in the investigational arm and 25.8\u202f±\u202f4.5 (20.0-40.0) in the standard of care arm', 'Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score\u202f≥']","['interleukin receptor 1 antagonist, Anakinra(100\u202fmg daily for 14\u202fdays) to suppress acute inflammation, pentoxifylline', 'zinc sulfate (220\u202fmg orally once daily for 6\u202fmonths) or the standard of care therapy including methylprednisolone']","['safety and efficacy', 'unadjusted log-rank test of the Kaplan-Meier survival estimates']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0206553', 'cui_str': 'Interleukin Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0333361', 'cui_str': 'Acute inflammation'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",104.0,0.725088,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","[{'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Cleveland Clinic, USA. Electronic address: dasaras@ccf.org.'}, {'ForeName': 'Mack C', 'Initials': 'MC', 'LastName': 'Mitchell', 'Affiliation': 'University of Texas at Southwestern University, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'University of Massachusetts, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'University of Louisville, USA.'}, {'ForeName': 'Gyongyi', 'Initials': 'G', 'LastName': 'Szabo', 'Affiliation': 'Harvard Medical School & Beth Israel Deaconess Medical Center, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Nagy', 'Affiliation': 'Cleveland Clinic, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Radaeva', 'Affiliation': 'National Institute of Alcohol Abuse and Alcoholism, USA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Cleveland Clinic, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106094']
1498,32740192,Dexmedetomidine Sedation in Mechanically Ventilated Critically Ill Children: A Pilot Randomized Controlled Trial.,"OBJECTIVES


To assess the feasibility, safety, and efficacy of a sedation protocol using dexmedetomidine as the primary sedative in mechanically ventilated critically ill children.
DESIGN


Open-label, pilot, prospective, multicenter, randomized, controlled trial. The primary outcome was the proportion of sedation scores in the target sedation range in the first 48 hours. Safety outcomes included device removal, adverse events, and vasopressor use. Feasibility outcomes included time to randomization and protocol fidelity.
SETTING


Six tertiary PICUs in Australia and New Zealand.
PATIENTS


Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours.
INTERVENTIONS


Children randomized to dexmedetomidine received a dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1). Children randomized to usual care received sedation as determined by the treating clinician (but not dexmedetomidine), also targeted to light sedation.
MEASUREMENTS AND MAIN RESULTS


Sedation with dexmedetomidine as the primary sedative resulted in a greater proportion of sedation measurements in the light sedation range (State Behavioral Scale -1 to +1) over the first 48 hours (229/325 [71%] vs 181/331 [58%]; p = 0.04) and the first 24 hours (66/103 [64%] vs 48/116 [41%]; p < 0.001) compared with usual care. Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements. Median time to randomization after intubation was 6.0 hours (interquartile range, 2.0-9.0 hr) in the dexmedetomidine arm compared with 3.0 hours (interquartile range, 1.0-7.0 hr) in the usual care arm (p = 0.24).
CONCLUSIONS


A sedation protocol using dexmedetomidine as the primary sedative was feasible, appeared safe, achieved early, light sedation, and reduced midazolam requirements. The findings of this pilot study justify further studies of sedative agents in critically ill children.",2020,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"['Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours', 'Mechanically Ventilated Critically Ill Children', 'critically ill children', 'Six tertiary PICUs in Australia and New Zealand', 'mechanically ventilated critically ill children']","['dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1', 'Dexmedetomidine Sedation', 'dexmedetomidine', 'usual care received sedation as determined by the treating clinician (but not dexmedetomidine']","['hypotension and bradycardia', 'proportion of sedation scores', 'feasibility, safety, and efficacy', 'proportion of sedation measurements', 'light sedation range (State Behavioral Scale -1 to +1', 'time to randomization and protocol fidelity', 'device removal, adverse events, and vasopressor use', 'Cumulative midazolam dosage', 'Median time to randomization after intubation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0752250', 'cui_str': 'Removal of device'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.154635,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Erickson', 'Affiliation': ""Paediatric Critical Care, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': ""Paediatric Intensive Care Unit, Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Paediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Marino S', 'Initials': 'MS', 'LastName': 'Festa', 'Affiliation': ""Kids Critical Care Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Lahn', 'Initials': 'L', 'LastName': 'Straney', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Debbie A', 'Initials': 'DA', 'LastName': 'Long', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002483']
1499,32740578,Abdominoplasty with Scarpa Fascia Preservation: Randomized Controlled Trial with Assessment of Scar Quality and Cutaneous Sensibility.,"BACKGROUND


Scarpa fascia preservation during abdominoplasty has been shown to reduce complications associated with the traditional technique. As an extension of a previously published randomized controlled trial, this study aims to clarify whether preservation of Scarpa fascia during abdominoplasty has an influence on scar quality or sensibility recovery.
METHODS


This was a single-center clinical trial, involving 160 patients randomly assigned to one of two surgical procedures: classic full abdominoplasty (group A) and abdominoplasty with preservation of Scarpa fascia (group B). Patients were later convoked to assess scar quality and abdominal cutaneous sensibility. Scar quality was evaluated through the Patient and Observer Scar Assessment Scale. Cutaneous sensibility was measured on the upper and lower abdomen, using light touch, Semmes-Weinstein testing (5.07/10-g monofilament), and a 25-gauge needle.
RESULTS


A total of 99 patients (group A, 54 patients; group B, 45 patients) responded to contact, with a mean follow-up time of 44 months. Concerning scar quality, Patient and Observer Scar Assessment Scale scores were similar between groups. On the upper abdomen, there was a statistically significant difference between groups on cutaneous sensibility, on the examination with the Semmes-Weinstein 5.07/10-g monofilament (group A, 79.6 percent; group B, 93.3 percent; p = 0.046) and pain (group A, 90.7 percent; group B, 100 percent; p = 0.044). No statistically significant differences were found between groups on the lower abdomen. A considerable proportion of patients (two-thirds) still presented sensibility alterations in the subumbilical area 3½ years after abdominoplasty.
CONCLUSION


Scarpa fascia preservation during abdominoplasty does not influence scar quality, but it improves sensibility recovery in the supraumbilical area.
CLINICAL QUESTION/LEVEL OF EVIDENCE


Therapeutic, II.",2020,"On the upper abdomen, there was a statistically significant difference between groups on cutaneous sensibility, on the examination with the Semmes-Weinstein 5.07/10-g monofilament (group A, 79.6 percent; group B, 93.3 percent; p = 0.046) and pain (group A, 90.7 percent; group B, 100 percent; p = 0.044).","['99 patients (group A, 54 patients; group B, 45 patients', '160 patients randomly assigned to one of two surgical procedures']","['classic full abdominoplasty (group A) and abdominoplasty with preservation of Scarpa fascia', 'Abdominoplasty with Scarpa Fascia Preservation']","['Patient and Observer Scar Assessment Scale', 'Cutaneous sensibility', 'Concerning scar quality, Patient and Observer Scar Assessment Scale scores', 'Scar quality', 'sensibility recovery', 'scar quality or sensibility recovery', 'scar quality', 'pain', 'scar quality and abdominal cutaneous sensibility', 'Scar Quality and Cutaneous Sensibility', 'cutaneous sensibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]",160.0,0.0753179,"On the upper abdomen, there was a statistically significant difference between groups on cutaneous sensibility, on the examination with the Semmes-Weinstein 5.07/10-g monofilament (group A, 79.6 percent; group B, 93.3 percent; p = 0.046) and pain (group A, 90.7 percent; group B, 100 percent; p = 0.044).","[{'ForeName': 'Catarina S', 'Initials': 'CS', 'LastName': 'Novais', 'Affiliation': 'Porto, Portugal From Porto University Medical School; the Department of Plastic, Aesthetic, and Reconstructive Surgery, São João University Hospital; the Department of Surgery and Physiology, Faculty of Medicine, Porto University; the Plastic Surgery Department, Portuguese Institute of Oncology of Porto; the Interdisciplinary Centre of Marine and Environmental Research; and the Department of Biology, Faculty of Sciences, University of Porto.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Carvalho', 'Affiliation': ''}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Valença-Filipe', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': ''}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Peres', 'Affiliation': ''}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Costa-Ferreira', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007024']
1500,32740950,Randomized Controlled Trial on the Effect of Partially Hydrolyzed Guar Gum Supplementation on Diarrhea Frequency and Gut Microbiome Count Among Pelvic Radiation Patients.,"BACKGROUND


Radiation therapy is the treatment of pelvic cancers, with diarrhea often being the most frequent acute side effect. This study aimed to determine the efficacy of partially hydrolyzed guar gum (PHGG) usage in reducing radiotherapy-induced diarrhea and improving bacterial count, nutrition status, and quality of life (QoL) among cancer patients.
METHODS


Adult patients undergoing pelvic radiation were recruited and randomly assigned to receive supplementation of either 10 g of PHGG or placebo (maltodextrin) twice daily, 14 days prior and 14 days during pelvic radiation. Diarrhea frequency, fecal samples, nutrition status, and QoL were assessed at baseline and days 14, 28 (2 weeks after pelvic radiation), and 45 (at the completion of pelvic radiation, 2 weeks' postsupplementation).
RESULTS


A total of 30 patients (mean age 56.5 ± 10.8 years, 75% malnourished) participated. The mean of diarrhea frequency in the intervention group (IG) was higher compared with the control group (CG) from days 14 and 28 but reduced at day 45. There was a significant intervention effect after controlling for confounders (ie, baseline diarrhea, age, nutrition status) (P < .05). Bifidobacterium count increased by double among the IG at 14 days of PHGG supplementation, whereas such trend was not observed in the CG.
CONCLUSION


Supplementation of PHGG potentially increased the bifidobacterial count and seemed to have post-supplementation effects by reducing the frequency of diarrhea upon the completion of pelvic radiation treatment.",2020,The mean of diarrhea frequency in Intervention Group (IG) was higher compared to the control (CG) from day 14 and 28 but reduced at day 45.,"['cancer patients', 'Pelvic Radiation Patients', 'Adult patients undergoing pelvic radiation', '30 patients (mean age 56.5 ± 10.8 years, 75% malnourished) participated']","['PHGG or placebo (maltodextrin', 'partially hydrolyzed guar gum (PHGG', 'Partially Hydrolyzed Guar Gum (PHGG) Supplementation']","['Bifidobacterium count', 'mean of diarrhea frequency', 'DAiarrhea Frequency and Gut Microbiome Count', 'bifidobacterial count', 'frequency of diarrhea', 'Diarrhea frequency, faecal samples, nutritional status and QoL', 'diarrhea and improving bacterial count, nutritional status and quality of life (QoL']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}]","[{'cui': 'C0061996', 'cui_str': 'guar gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",30.0,0.0979944,The mean of diarrhea frequency in Intervention Group (IG) was higher compared to the control (CG) from day 14 and 28 but reduced at day 45.,"[{'ForeName': 'Dzairudzee', 'Initials': 'D', 'LastName': 'Rosli', 'Affiliation': 'Hospital, Tawau, Ministry of Health Malaysia, 67, Peti Surat, Tawau, Sabah, 91007, Malaysia.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Shahar', 'Affiliation': 'Dietetic Programme, Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, 50300, Malaysia.'}, {'ForeName': 'Zahara Abdul', 'Initials': 'ZA', 'LastName': 'Manaf', 'Affiliation': 'Dietetic Programme, Centre for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, 50300, Malaysia.'}, {'ForeName': 'Hui Jin', 'Initials': 'HJ', 'LastName': 'Lau', 'Affiliation': 'Nutrition Programme, Centre for Healthy Aging and Wellness, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, 50300, Malaysia.'}, {'ForeName': 'Nurul Yuziana Mohd', 'Initials': 'NYM', 'LastName': 'Yusof', 'Affiliation': 'Faculty of Science and Technology, Universiti Kebangsaan Malaysia, Bangi, 43600, Malaysia.'}, {'ForeName': 'Mohd Roslan', 'Initials': 'MR', 'LastName': 'Haron', 'Affiliation': 'Hospital Sultan Ismail, Ministry of Health Malaysia, Jalan Mutiara Emas Utama, Johor, 81100, Malaysia.'}, {'ForeName': 'Hazreen Abdul', 'Initials': 'HA', 'LastName': 'Majid', 'Affiliation': 'Centre for Population Health and Department of Social and Preventive Medicine, Faculty of Medicine, University Malaya, Jalan Universiti, Kuala Lumpur, 50603, Malaysia.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1987']
1501,32746317,Should Hands Be Restricted When Measuring Able-Bodied Participants to Evaluate Machine Learning Controlled Prosthetic Hands?,"OBJECTIVE


When evaluating methods for machine-learning controlled prosthetic hands, able-bodied participants are often recruited, for practical reasons, instead of participants with upper limb absence (ULA). However, able-bodied participants have been shown to often perform myoelectric control tasks better than participants with ULA. It has been suggested that this performance difference can be reduced by restricting the wrist and hand movements of able-bodied participants. However, the effect of such restrictions on the consistency and separability of the electromyogram's (EMG) features remains unknown. The present work investigates whether the EMG separability and consistency between unaffected and affected arms differ and whether they change after restricting the unaffected limb in persons with ULA.
METHODS


Both arms of participants with unilateral ULA were compared in two conditions: with the unaffected hand and wrist restricted or not. Furthermore, it was tested if the effect of arm and restriction is influenced by arm posture (arm down, arm in front, or arm up).
RESULTS


Fourteen participants (two women, age = 53.4±4.05) with acquired transradial limb loss were recruited. We found that the unaffected limb generated more separated EMG than the affected limb. Furthermore, restricting the unaffected hand and wrist lowered the separability of the EMG when the arm was held down.
CONCLUSION


Limb restriction is a viable method to make the EMG of able-bodied participants more similar to that of participants with ULA.
SIGNIFICANCE


Future research that evaluates methods for machine learning controlled hands in able-bodied participants should restrict the participants' hand and wrist.",2020,Both arms of participants with unilateral ULA were compared in two conditions: with the unaffected hand and wrist restricted or not.,"['persons with ULA', 'participants with upper limb absence (ULA', 'Fourteen participants (two women, age=53.4±4.05) with acquired transradial limb loss were recruited']",[],['EMG separability and consistency'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0002695', 'cui_str': 'Amputee'}]",[],"[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",14.0,0.0755387,Both arms of participants with unilateral ULA were compared in two conditions: with the unaffected hand and wrist restricted or not.,"[{'ForeName': 'Morten B', 'Initials': 'MB', 'LastName': 'Kristoffersen', 'Affiliation': ''}, {'ForeName': 'Andreas W', 'Initials': 'AW', 'LastName': 'Franzke', 'Affiliation': ''}, {'ForeName': 'Corry K', 'Initials': 'CK', 'LastName': 'van der Sluis', 'Affiliation': ''}, {'ForeName': 'Raoul M', 'Initials': 'RM', 'LastName': 'Bongers', 'Affiliation': ''}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Murgia', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2020.3007803']
1502,32746774,"Effects of Two Weekly Servings of Cod for 16 Weeks in Pregnancy on Maternal Iodine Status and Infant Neurodevelopment: Mommy's Food, a Randomized-Controlled Trial.","Background:  Mild-to-moderate iodine deficiency is still present in many countries, particularly in pregnant women. Observational studies suggest that mild-to-moderate iodine deficiency during pregnancy may be associated with impaired thyroid function and child neurodevelopment. Randomized-controlled food trials to increase iodine status are scarce. We assessed the impact of an increased intake of cod during pregnancy on maternal iodine status and infant neurodevelopment.  Methods:  In this randomized-controlled trial, pregnant women in Bergen, Norway, recruited through Haukeland University Hospital, were randomly assigned (1:1) to an intervention of 200 g of cod twice a week for 16 weeks (gestational week 20-36) or to continue with their standard diet (control group). Randomization was done by lottery. Primary outcome was urinary iodine concentration (UIC) (spot samples from six consecutive days) measured postintervention. Secondary outcome was infant neurodevelopment assessed by the cognitive, language, and motor scales of the  Bayley Scales of Infant and Toddler Developmental  third edition (Bayley-III) at 11 months of age. In addition, maternal thyroid function was measured (thyrotropin [TSH], free triiodothyronine [fT3], free thyroxine [fT4]) at baseline and postintervention.  Results:  Between January 2016 until February 2017, 137 women were recruited. Postintervention UIC was higher in the intervention group ( n  = 61) [median (interquartile range, IQR) 98 (64-145) μg/L], compared with control ( n  = 61) [median (IQR) 73 (52-120) μg/L] ( p  = 0.028), also after adjusting for baseline UIC ( p  = 0.048). Infants of mothers in the intervention group had a lower cognitive composite score on the Bayley-III compared with the control group ( p  = 0.045). There were no group differences in the Bayley III language- or motor composite scores. Maternal thyroid hormones (TSH, fT3, fT4) did not differ between the groups postintervention.  Conclusions:  Increased cod intake during pregnancy improved the iodine status in women with mild-to-moderate iodine deficiency, however, did not affect thyroid function. The negative effect on cognition should be followed up to assess whether this is a stable effect over time. More studies are warranted to enable good health advice on iodine nutrition in pregnancy. ClinicalTrials.gov NCT02610959. Registered November 20, 2015.",2020,"Infants of mothers in the intervention group had a lower cognitive composite score on the Bayley-III compared to the control group, (p= 0.045).","['Results Between Jan 2016 until Feb 2017', 'pregnant women in Bergen, Norway, recruited through Haukeland University Hospital', '137 women were recruited', 'pregnant women']",[],"['lower cognitive composite score', 'urinary iodine concentration (UIC) (spot samples', 'Maternal thyroid hormones (TSH, fT3, fT4', 'infant neurodevelopment assessed by the cognitive, language and motor scales of the Bayley Scales of Infant and Toddler Developmental 3rd edition (Bayley-III', 'Bayley III language- or motor composite scores', 'maternal iodine status and infant neurodevelopment', 'maternal thyroid function', 'maternal iodine status, and infant neurodevelopment']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",137.0,0.201058,"Infants of mothers in the intervention group had a lower cognitive composite score on the Bayley-III compared to the control group, (p= 0.045).","[{'ForeName': 'Maria Wik', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Lisa Kolden', 'Initials': 'LK', 'LastName': 'Midtbø', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Ive', 'Initials': 'I', 'LastName': 'Nerhus', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Synnøve', 'Initials': 'S', 'LastName': 'Næss', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Aakre', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Dahl', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Kjellevold', 'Affiliation': 'Seafood, Nutrition and Environmental State, Institute of Marine Research, Bergen, Norway.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2020.0115']
1503,32749877,"Understanding of Perceived Infectiousness and Its Influence on Sexual Behavior Among Individuals With Acute HIV Infection in Lilongwe, Malawi (HPTN 062).","We implemented HPTN 062, an acceptability and feasibility study of a motivational-interviewing (MI) intervention to reduce HIV transmission among individuals with acute HIV infection (AHI) in Lilongwe, Malawi. Participants were randomly assigned to receive either brief education or the MI intervention over 24 weeks; all participants received the same messages about AHI. We used mixed methods to assess participants' understanding of the association between AHI and viral load, and its connection to sexual behavior at 8 weeks. While most participants understood key aspects of AHI, MI-intervention participants gave substantially more detailed descriptions of their understanding. Nearly all participants, regardless of study arm, understood that they were highly infectious and would be very likely to transmit HIV after unprotected sex during AHI. Our findings suggest that messages about AHI delivered during the period of AHI are likely beneficial for ensuring that those with AHI understand their level of infectiousness and its association with forward transmission.",2020,"Nearly all participants, regardless of study arm, understood that they were highly infectious and would be very likely to transmit HIV after unprotected sex during AHI.","['Individuals With Acute HIV Infection in Lilongwe, Malawi', 'individuals with acute HIV infection (AHI) in Lilongwe, Malawi']","['brief education or the MI intervention', 'motivational-interviewing (MI) intervention']",['Sexual Behavior'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0351249,"Nearly all participants, regardless of study arm, understood that they were highly infectious and would be very likely to transmit HIV after unprotected sex during AHI.","[{'ForeName': 'Tiarney D', 'Initials': 'TD', 'LastName': 'Ritchwood', 'Affiliation': 'Department of Family Medicine and Community Health, School of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Massa', 'Affiliation': 'UNC Project Lilongwe, Lilongwe, Malawi.'}, {'ForeName': 'Gift', 'Initials': 'G', 'LastName': 'Kamanga', 'Affiliation': 'FHI 360, Lilongwe, Malawi.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Corneli', 'Affiliation': 'Department of Population Health Sciences, School of Medicine, Duke University, and the Duke Clinical Research Institute, Duke University.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.3.260']
1504,32750431,Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.,"BACKGROUND


Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss.
METHODS


Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support.
DISCUSSION


This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.",2020,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.",['Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity'],"['training in principles of cognitive behavioral therapy', 'standard weight management program alone or with their partner']","['Partner weight and caloric intake', 'participant weight loss at 24\u202fmonths, with caloric intake and moderate-intensity physical activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0164121,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.","[{'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA; William S Middleton Memorial Veterans Hospital, 2500 Overlook Terrace (151), Madison, WI 53705, USA. Electronic address: voils@surgery.wisc.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': 'Duke University School of Nursing, 307 Trent Dr., 1055 Clipp, Durham, NC 27710, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Adler', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, One Brigham Circle, 1620 Tremont Street Suite 2-016, Boston, MA 02120, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jeanes', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, 119 S. Main St., Union Trust Bldg., Suite 220, Seattle, WA 98104, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Cronin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Johnson', 'Affiliation': ""Boca Raton Regional Hospital, Christine E. Lynn Women's Health & Wellness Institute, 690 Meadows Road, Boca Raton, FL 33486, USA.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Elwert', 'Affiliation': 'University of Wisconsin-Madison Department of Sociology, 11800 Observatory Dr, Madison, WI 53706, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Medicine, 1685 Highland Ave Madison, WI 53705-2281, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Gavin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University School of Medicine, Department of Medicine, 501 Douglas St., Durham, NC 27705, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Box 90399, Durham, NC 27708, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106092']
1505,32750499,Improving episodic memory: Frontal-midline theta neurofeedback training increases source memory performance.,"Cognitive and neurofeedback training (NFT) studies have demonstrated that training-induced alterations of frontal-midline (FM) theta activity (4-8 Hz) transfer to cognitive control processes. Given that FM theta oscillations are assumed to provide top-down control for episodic memory retrieval, especially for source retrieval, that is, accurate recollection of contextual details of prior episodes, the present study investigated whether FM theta NFT transfers to memory control processes. It was assessed (1) whether FM theta NFT improves source retrieval and modulates its underlying EEG characteristics and (2) whether this transfer extends over two posttests. Over seven NFT sessions, the training group who trained individual FM theta activity showed greater FM theta increase than an active control group who trained randomly chosen frequency bands. The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases. Thus, training-induced enhancement of memory control processes seems to protect newly formed memories from proactive interference of previously learned information. EEG analyses revealed that during pretest both groups showed source memory specific theta activity at frontal and parietal sites. Surprisingly, training-induced improvements in source retrieval tended to be accompanied by less prestimulus FM theta activity, which was predicted by NFT theta change for the training but not the control group, suggesting a more efficient use of memory control processes after training. The present findings provide unique evidence for the enhancement of memory control processes by FM theta NFT.",2020,The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases.,[],"['FM theta NFT', 'Cognitive and neurofeedback training (NFT']","['FM theta increase', 'source retrieval', 'source memory specific theta activity']",[],"[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0178591,The training group showed better source retrieval in a posttraining session performed 13 days after NFT and their performance increases from pre- to both posttraining sessions were predicted by NFT theta increases.,"[{'ForeName': 'Kathrin C J', 'Initials': 'KCJ', 'LastName': 'Eschmann', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany; Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Cardiff, United Kingdom. Electronic address: eschmannk@cardiff.ac.uk.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Bader', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Mecklinger', 'Affiliation': 'Experimental Neuropsychology Unit, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117219']
1506,32753561,"Trends and survival outcomes of robotic, laparoscopic, and open surgery for stage II uterine cancer.","INTRODUCTION


A recent randomized clinical trial showed that minimally invasive surgery led to poorer survival compared with open surgery in early stage cervical cancer. We determined the trends in adoption of minimally invasive surgery and 5-year overall survival outcomes after open, laparoscopic-assisted, and robotic-assisted hysterectomy for stage II uterine cancer with cervical stromal involvement.
METHODS


Data for patients with stage II uterine cancer were acquired from the National Cancer Database from 2010 to 2015. χ 2  testing, Kaplan-Meier methods, and Cox models were used for statistical analyses.
RESULTS


Of 2949 patients, 44.3% underwent open hysterectomy, 13.9% underwent laparoscopic hysterectomy, and 41.8% underwent robotic hysterectomy. The proportion of robotic cases increased from 26.8% in 2010 to 48.3% in 2015 (annual percent change 10.1%), with a decrease in open hysterectomy from 63.3% to 34.3% (annual percent change -12.5%). The overall 5-year survival was 77.6% in robotic, 76.8% in laparoscopic, and 72.5% in open hysterectomy (p=0.045); however, after adjusting for known prognostic factors, robotic (HR 1.00, 95% CI 0.82 to 1.21; p=0.97) and laparoscopic hysterectomy (HR 1.09, 95% CI 0.83 to 1.44; p=0.54) did not portend for improved survival compared with open hysterectomy. Black women (HR 1.59, 95% CI 1.25 to 2.02; p<0.001) and individuals with co-morbidities (HR 1.45, 95% CI 1.21 to 1.75, p<0.001) had worse adjusted survival and the highest rates of open hysterectomy.
CONCLUSION


The use of minimally invasive surgery for stage II uterine cancer has increased over time, with comparable adjusted 5-year survival after robotic or laparoscopic hysterectomy compared with open hysterectomy. Black women and those with co-morbidities had lowest rates of minimally invasive surgery and the poorest adjusted survival.",2020,"The use of minimally invasive surgery for stage II uterine cancer has increased over time, with comparable adjusted 5-year survival after robotic or laparoscopic hysterectomy compared with open hysterectomy.","['early stage cervical cancer', 'Of 2949 patients, 44.3% underwent', 'stage II uterine cancer', 'stage II uterine cancer with cervical stromal involvement', 'patients with stage II uterine cancer were acquired from the National Cancer Database from 2010 to 2015']","['open hysterectomy', 'laparoscopic hysterectomy', 'laparoscopic-assisted, and robotic-assisted hysterectomy', 'robotic hysterectomy', 'minimally invasive surgery', 'robotic, laparoscopic, and open surgery']","['5-year survival', 'overall 5-year survival', 'open hysterectomy', 'poorer survival', 'survival', 'laparoscopic hysterectomy', 'adjusted survival', 'proportion of robotic cases', '5-year overall survival outcomes', 'individuals with co-morbidities']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278799', 'cui_str': 'Endometrial cancer stage II'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",2949.0,0.377133,"The use of minimally invasive surgery for stage II uterine cancer has increased over time, with comparable adjusted 5-year survival after robotic or laparoscopic hysterectomy compared with open hysterectomy.","[{'ForeName': 'Mary Kathryn', 'Initials': 'MK', 'LastName': 'Abel', 'Affiliation': 'School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'Division of Gynecologic Oncology, Palo Alto Medical Foundation, California Pacific Medical Center, Sutter Health, San Francisco, California, USA chanjohn@sutterhealth.org.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chow', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Darcy', 'Affiliation': 'Gynecologic Cancer Center of Excellence, Department of Obstetrics & Gynecology, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Chunqiao', 'Initials': 'C', 'LastName': 'Tian', 'Affiliation': 'Gynecologic Cancer Center of Excellence, Department of Obstetrics & Gynecology, Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Kapp', 'Affiliation': 'Department of Radiation Oncology, Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Amandeep K', 'Initials': 'AK', 'LastName': 'Mann', 'Affiliation': 'Division of Gynecologic Oncology, Palo Alto Medical Foundation Research Institute, Palo Alto, California, USA.'}, {'ForeName': 'Cheng-I', 'Initials': 'CI', 'LastName': 'Liao', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001646']
1507,32756825,Effectiveness of a handmade shell-based substrate for the breeding of Biomphalaria glabrata under laboratory conditions.,"Efficient snail production is essential for the proper maintenance of the Schistosoma mansoni life cycle in the laboratory. In order to improve the breeding of Biomphalaria glabrata under laboratory conditions, this study aimed to demonstrate the effectiveness of a handmade shell-based substrate on the physiological performance of B. glabrata. The shells used to make the substrate were cleaned, sterilized and macerated until a powder was obtained (yield of 92.3%). B. glabrata specimens were randomly assigned to three treatment groups: negative control group (NCG) exposed to a clay-only substrate; a positive control group (PCG) containing clay, oyster flour and calcium carbonate; and the test group (TG) with the shell-based substrate and clay. B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG. Therefore, the shell-based substrate proved to be efficient and has a low cost for the breeding of B. glabrata.",2020,"B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG.",['B. glabrata specimens'],"['handmade shell-based substrate', 'negative control group (NCG) exposed to a clay-only substrate; a positive control group (PCG) containing clay, oyster flour and calcium carbonate; and the test group (TG) with the shell-based substrate and clay']","['improved growth, sexual maturity, fertility, mortality rate, and shell morphology']","[{'cui': 'C0319899', 'cui_str': 'Candida glabrata'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030104', 'cui_str': 'Oyster'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0233891', 'cui_str': 'Finding related to maturity of sexuality'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",,0.016931,"B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG.","[{'ForeName': 'João Gustavo Mendes', 'Initials': 'JGM', 'LastName': 'Rodrigues', 'Affiliation': 'Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Gabriela Sampaio', 'Initials': 'MGS', 'LastName': 'Lira', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Ranielly Araújo', 'Initials': 'RA', 'LastName': 'Nogueira', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Gleycka Cristine Carvalho', 'Initials': 'GCC', 'LastName': 'Gomes', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Irlla Correia Lima', 'Initials': 'ICL', 'LastName': 'Licá', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Davi', 'Initials': 'D', 'LastName': 'Viegas-Melo', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Teles-Reis', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Guilherme Silva', 'Initials': 'GS', 'LastName': 'Miranda', 'Affiliation': 'Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Nêuton', 'Initials': 'N', 'LastName': 'Silva-Souza', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}]",Revista do Instituto de Medicina Tropical de Sao Paulo,['10.1590/s1678-9946202062055']
1508,32716001,Effects of pony-assisted therapy on the behavior of older people with neurocognitive disorders living in nursing homes.,"CONTEXT


Experienced in psychomotricity in two nursing homes, pony-assisted therapy shows first positive effects on psycho-behavioral symptoms. Recognized in the field of disability and psychiatry, this form of therapy is not developed in gerontology.
OBJECTIVES


To measure the effects of this therapy on the behavior of elderly people with neurocognitive disorders living in long-term care and especially on the involvement in this activity. Anxiety and apathy were chosen as the measurement criteria.
METHODS


An intervention study with an experimental cross-study design was conducted over two months for 23 subjects. An intervention group was studied during a period with TAP and a period without TAP. Another group without intervention was also studied. All participants were assessed before and after intervention with the NPI-R scale. The engagement during two TAP sessions and one animation time was also evaluated with the ECPAI scale.
RESULTS


In the crossover study, positive engagement is more important in participant/pony interaction than in participant/facilitator interaction (p<0.01). The ECPAI score reflecting apathetic behavior was significantly decreased during interaction with the animal than in the interaction with the facilitator in patients undergoing therapy (p<0.01). The ECPAI score reflecting engagement is greater in pony interaction for participants in therapy than in the control group in facilitator interaction (p<0.01). There is no significant change in the scores for the anxiety and apathy items on the NPI-R scale.
CONCLUSION


TAP participates in the positive engagement of the elderly people in the interaction with the animal. These results are consistent with the conclusions of the studies on animal mediation and confirm the clinical observations collected. TAP could work by improving self-esteem and valuing all of the person's preserved abilities.",2020,The ECPAI score reflecting engagement is greater in pony interaction for participants in therapy than in the control group in facilitator interaction (p<0.01).,"['older people with neurocognitive disorders living in nursing homes', '23 subjects', 'elderly people with neurocognitive disorders living in long-term care']","['pony-assisted therapy', 'TAP', 'TAP and a period without TAP']","['psycho-behavioral symptoms', 'ECPAI score reflecting apathetic behavior', 'self-esteem', 'NPI-R scale']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0324180', 'cui_str': 'Pony'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}]","[{'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",23.0,0.0238065,The ECPAI score reflecting engagement is greater in pony interaction for participants in therapy than in the control group in facilitator interaction (p<0.01).,"[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Carillon', 'Affiliation': 'Sorbonne Université, Paris, France, Pôle médical, Ehpad Arpavie Sainte-Lucie, Issy-les-Moulineaux, France, Pôle médical, Ehpad Korian Hauts de Jardy, Vaucresson, France.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Jarzebowski', 'Affiliation': 'Court Séjour Gériatrique, Centre Hospitalier de Bastia, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Fulpin', 'Affiliation': 'Pôle médical, Ehpad Arpavie Sainte-Lucie, Issy-les-Moulineaux, France.'}, {'ForeName': 'Adélaïde', 'Initials': 'A', 'LastName': 'Miliotis', 'Affiliation': 'Pôle médical, Ehpad Korian Hauts de Jardy, Vaucresson, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bernadac', 'Affiliation': 'Pôle médical, Ehpad Korian Hauts de Jardy, Vaucresson, France.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Saint-Georges Chaumet', 'Affiliation': 'Bioredac, Chambourcy, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Belmin', 'Affiliation': 'Sorbonne Université, Paris, France, Service de gériatrie, Hôpital Charles-Foix, AP-HP, Ivry-sur-Seine, France.'}]",Geriatrie et psychologie neuropsychiatrie du vieillissement,['10.1684/pnv.2020.0854']
1509,32712460,Effect of a newly developed ready-to-use supplementary food on growth indicators in children with mild to moderate malnutrition.,"OBJECTIVES


Malnutrition is one of the leading causes of death among children younger than five years. In this study, we aimed to formulate a ready-to-use supplementary food (RUSF), based on local food products, and investigate its efficacy on growth indicators in children with mild to moderate malnutrition.
STUDY DESIGN


This is a randomized controlled clinical trial.
METHODS


This study was performed in six health centers in Shahr-e-Rey, Tehran, Iran, between April and October 2017. One hundred children, aged 24-59 months, with mild to moderate malnutrition (weight-for-height Z-score [WHZ] between -3 and -1) were randomly assigned to two groups to receive either 1-3 sachets of RUSF or normal diet for 8 weeks. All mothers and caregivers received nutrition education. Growth indicators including weight and height, WHZ, and body mass index (BMI), along with clinical outcomes, were assessed.
RESULTS


Children who received RUSF had a significant increase in weight (1.44 ± 0.38 vs 0.7 ± 0.32 kg, respectively, P < 0.001), and BMI (1.2 ± 0.47 vs 0.35 ± 0.33 kg/m 2 , respectively, P < 0.001) compared with the control group. There was a greater daily weight gain during the first 4 weeks (P < 0.001) and throughout the study (P = 0.013) in the RUSF group. Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027). Children in the RUSF group had more improvement in WHZ (1.18 ± 0.41 vs 0.41 ± 0.31, P < 0.001) after supplementation. Besides, 92% of the RUSF and 12% of the control group reached to WHZ > -1 at the end of the study (P < 0.001). There was lower prevalence of diarrhea (12% vs 28.6%, respectively, P = 0.01) and marginally lower fever (16% vs 36.7%, respectively, P = 0.05) in the intervention than in the control group.
CONCLUSIONS


A newly developed RUSF improved growth indicators and clinical outcomes in children with mild to moderate malnutrition.
CLINICAL TRIAL REGISTRY NUMBER


IRCT2017021315536N6 (registered at www.irct.ir).",2020,Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027).,"['children with mild to moderate malnutrition', 'One hundred children, aged 24-59 months, with mild to moderate malnutrition (weight-for-height Z-score [WHZ] between\xa0-3 and\xa0-1', 'six health centers in Shahr-e-Rey, Tehran, Iran, between April and October 2017', 'children younger than five years']","['RUSF or normal diet', 'nutrition education', 'RUSF', 'ready-to-use supplementary food (RUSF']","['diarrhea', 'weight', 'Daily height gain', 'weight and height, WHZ, and body mass index (BMI', 'BMI', 'daily weight gain', 'WHZ', 'fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",100.0,0.0904359,Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Azimi', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Esmaillzadeh', 'Affiliation': 'Department of Community Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alipoor', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moslemi', 'Affiliation': 'Food and Drug Laboratories Research Center, Food and Drug Administration, Ministry of Health and Medical Education, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran; Cardiac Primary Prevention Research Center (CPPRC), Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hosseinzadeh.md.phd@gmail.com.'}]",Public health,['10.1016/j.puhe.2020.06.025']
1510,32713367,Low-frequency rTMS inhibits the anti-depressive effect of ECT. A pilot study.,"OBJECTIVE


Low-frequency repetitive transcranial magnetic stimulation (rTMS) of the prefrontal cortex has been shown to have a statistically and clinically significant anti-depressant effect. The present pilot study was carried out to investigate if right prefrontal low-frequency rTMS as an add-on to electroconvulsive therapy (ECT) accelerates the anti-depressant effect and reduces cognitive side effects.
METHODS


In this randomised, controlled, double-blind study, thirty-five patients with major depression were allocated to ECT+placebo or ECT+low-frequency right prefrontal rTMS. The severity of depression was evaluated during the course using the Hamilton scale for depression (the 17-item as well as the 6-item scale) and the major depression inventory (MDI). Furthermore, neuropsychological assessment of cognitive function was carried out.
RESULTS


The study revealed no significant difference between the two groups for any of the outcomes, but with a visible trend to lower scores for MDI after treatment in the placebo group. The negative impact of ECT on neurocognitive functions was short-lived, and scores on logical memory were significantly improved compared to baseline 4 weeks after last treatment. The ECT-rTMS group revealed generally less impairment of cognitive functions than the ECT-placebo group.
CONCLUSION


The addition of low-frequency rTMS as an add-on to ECT treatment did not result in an accelerated response. On the contrary, the results suggest that low-frequency rTMS could inhibit the anti-depressant effect of ECT.",2020,The negative impact of ECT on neurocognitive functions was short lived and scores on logical memory were significantly improved compared to baseline 4 weeks after last treatment.,['thirty-five patients with major depression'],"['ECT-placebo', 'ECT', 'ECT+placebo or ECT+ low frequency right prefrontal rTMS', 'placebo']","['MDI', 'severity of depression', 'neurocognitive functions', 'impairment of cognitive functions', 'logical memory']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",35.0,0.0316993,The negative impact of ECT on neurocognitive functions was short lived and scores on logical memory were significantly improved compared to baseline 4 weeks after last treatment.,"[{'ForeName': 'Poul Erik', 'Initials': 'PE', 'LastName': 'Buchholtz', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ashkanian', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hjerrild', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Line Kirstine', 'Initials': 'LK', 'LastName': 'Hauptmann', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Torben Albert', 'Initials': 'TA', 'LastName': 'Devantier', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Jensen', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Wissing', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mette Viller', 'Initials': 'MV', 'LastName': 'Thorgaard', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Laerke', 'Initials': 'L', 'LastName': 'Bjerager', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lund', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anja Johnsen', 'Initials': 'AJ', 'LastName': 'Alrø', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Maria Simonsen', 'Initials': 'MS', 'LastName': 'Speed', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Rene Børge Korsgaard', 'Initials': 'RBK', 'LastName': 'Brund', 'Affiliation': 'Department for Affective Disorders, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Poul', 'Initials': 'P', 'LastName': 'Videbech', 'Affiliation': 'Center for Neuropsychiatric Depression Research, Mental Health Center Glostrup, Copenhagen, Denmark.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.28']
1511,32717180,"Second-look surgery plus hyperthermic intraperitoneal chemotherapy versus surveillance in patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15): a randomised, phase 3 study.","BACKGROUND


Diagnosis and treatment of colorectal peritoneal metastases at an early stage, before the onset of signs, could improve patient survival. We aimed to compare the survival benefit of systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC), with surveillance, in patients at high risk of developing colorectal peritoneal metastases.
METHODS


We did an open-label, randomised, phase 3 study in 23 hospitals in France. Eligible patients were aged 18-70 years and had a primary colorectal cancer with synchronous and localised colorectal peritoneal metastases removed during tumour resection, resected ovarian metastases, or a perforated tumour. Patients were randomly assigned (1:1) to surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m 2 , or oxaliplatin 300 mg/m 2  plus irinotecan 200 mg/m 2 , plus intravenous fluorouracil 400 mg/m 2 ), or mitomycin-HIPEC (mitomycin 35 mg/m 2 ) alone in case of neuropathy, after 6 months of adjuvant systemic chemotherapy with no signs of disease recurrence. Randomisation was done via a web-based system, with stratification by treatment centre, nodal status, and risk factors for colorectal peritoneal metastases. Second-look surgery consisted of a complete exploration of the abdominal cavity via xyphopubic incision, and resection of all peritoneal implants if resectable. Surveillance after resection of colorectal cancer was done according to the French Guidelines. The primary outcome was 3-year disease-free survival, defined as the time from randomisation to peritoneal or distant disease recurrence, or death from any cause, whichever occurred first, analysed by intention to treat. Surgical complications were assessed in the second-look surgery group only. This study was registered at ClinicalTrials.gov, NCT01226394.
FINDINGS


Between June 11, 2010, and March 31, 2015, 150 patients were recruited and randomly assigned to a treatment group (75 per group). After a median follow-up of 50·8 months (IQR 47·0-54·8), 3-year disease-free survival was 53% (95% CI 41-64) in the surveillance group versus 44% (33-56) in the second-look surgery group (hazard ratio 0·97, 95% CI 0·61-1·56). No treatment-related deaths were reported. 29 (41%) of 71 patients in the second-look surgery group had grade 3-4 complications. The most common grade 3-4 complications were intra-abdominal adverse events (haemorrhage, digestive leakage) in 12 (23%) of 71 patients and haematological adverse events in 13 (18%) of 71 patients.
INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance. Currently, essential surveillance of patients at high risk of developing colorectal peritoneal metastases appears to be adequate and effective in terms of survival outcomes.
FUNDING


French National Cancer Institute.",2020,"INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance.","['Between June 11, 2010, and March 31, 2015, 150 patients', 'Eligible patients were aged 18-70 years and had a primary colorectal cancer with synchronous and localised colorectal peritoneal metastases removed during tumour resection, resected ovarian metastases, or a perforated tumour', 'patients at high risk of developing colorectal peritoneal metastases (PROPHYLOCHIP-PRODIGE 15', 'patients at high risk of developing colorectal peritoneal metastases', '23 hospitals in France']","['oxaliplatin-HIPEC', 'surveillance or second-look surgery plus oxaliplatin-HIPEC (oxaliplatin 460 mg/m 2 , or oxaliplatin 300 mg/m 2  plus irinotecan 200 mg/m 2 , plus intravenous fluorouracil 400 mg/m 2 ), or mitomycin-HIPEC (mitomycin 35 mg/m 2 ) alone in case of neuropathy, after 6 months of adjuvant systemic chemotherapy', 'Second-look surgery plus hyperthermic intraperitoneal chemotherapy', 'systematic second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC']","['grade 3-4 complications', '3-year disease-free survival, defined as the time from randomisation to peritoneal or distant disease recurrence, or death from any cause, whichever occurred first, analysed by intention to treat', 'intra-abdominal adverse events (haemorrhage, digestive leakage', '3-year disease-free survival', 'disease-free survival', 'haematological adverse events', 'Surgical complications']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant neoplasm of peritoneum'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0022790', 'cui_str': 'Krukenberg tumor'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0949626', 'cui_str': 'Incision and reexploration for second look'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0012238', 'cui_str': 'Digestive system function'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",150.0,0.506933,"INTERPRETATION


Systematic second-look surgery plus oxaliplatin-HIPEC did not improve disease-free survival compared with standard surveillance.","[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Goéré', 'Affiliation': 'Department of Surgical Oncology, University Hospital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France; Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France. Electronic address: diane.goere@aphp.fr.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Glehen', 'Affiliation': 'Department of Surgical Oncology, University Hospital Lyon Sud, Pierre Bénite, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Quenet', 'Affiliation': 'Department of Surgical Oncology, Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guilloit', 'Affiliation': 'Department of Surgical Oncology, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Bereder', 'Affiliation': 'Department of Surgical Oncology, University Hospital de Larchet, Nice, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lorimier', 'Affiliation': 'Department of Surgical Oncology, Centre Paul Papin, Angers, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Thibaudeau', 'Affiliation': ""Department of Surgical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Ghouti', 'Affiliation': 'Department of Surgical Oncology, University Hospital Purpan, Toulouse, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Pinto', 'Affiliation': 'Department of Surgical Oncology, University Hospital Purpan, Toulouse, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Tuech', 'Affiliation': 'Department of Surgical Oncology, University Hospital Charles Nicolle, Rouen, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kianmanesh', 'Affiliation': 'Department of Surgical Oncology, University Hospital Robert Debré, Reims, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Carretier', 'Affiliation': 'Department of Surgical Oncology, University Hospital de Poitiers, Poitiers, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Marchal', 'Affiliation': 'Department of Surgical Oncology, Institut de Cancérologie de Lorraine, Nancy, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Arvieux', 'Affiliation': 'Department of Visceral Surgery, University Hospital, Grenoble, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Surgical Oncology, University Hospital Hautepierre, Strasbourg, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meeus', 'Affiliation': 'Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rat', 'Affiliation': 'Department of Surgical Oncology, University Hospital du Bocage, Dijon, France.'}, {'ForeName': 'Sylvaine', 'Initials': 'S', 'LastName': 'Durand-Fontanier', 'Affiliation': 'Department of Surgical Oncology, University Hospital Dupuytren, Limoges, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Mariani', 'Affiliation': 'Department of Surgical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Lakkis', 'Affiliation': 'Department of Surgical Oncology, University Hospital Jean Minjoz, Besançon, France.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Loi', 'Affiliation': 'Department of Surgical Oncology, University Hospital Tenon, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pirro', 'Affiliation': 'Department of Surgical Oncology, University Hospital La Timone, Marseille, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sabbagh', 'Affiliation': 'Department of Surgical Oncology, University Hospital Amiens-Picardie, Amiens, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Texier', 'Affiliation': 'Department of Biostatistics, University Hospital Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Elias', 'Affiliation': 'Department of Surgical Oncology, University Hospital Gustave Roussy, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30322-3']
1512,32718528,"Aprepitant in the Treatment of Subacute Sclerosing Panencephalitis: A Randomized, Double-Blind, Placebo-Controlled Study.","BACKGROUND


Aprepitant is a neurokinin-1 receptor antagonist approved for the treatment of chemotherapy-induced nausea. We aimed to investigate the safety and efficacy of aprepitant in patients with subacute sclerosing panencephalitis.
METHODS


A randomized, double-blind, placebo-controlled study was conducted in patients with subacute sclerosing panencephalitis assigned to receive two courses of aprepitant 250 mg/day orally or placebo for 15 days with an interval of two months between courses. Primary end points were safety and tolerability, and secondary end point was clinical improvement or stabilization assessed by subacute sclerosing panencephalitis scoring system. Electroencephalography (EEG), brain magnetic resonance imaging, and cerebrospinal fluid measles-specific immunoglobulin G index were evaluated before and after treatment.
RESULTS


Sixty-two patients with subacute sclerosing panencephalitis were allocated to aprepitant (n = 31, median age 18 years) or placebo (n = 31, median age 22 years) group. Fifteen patients left the study within the first six months and 12 patients left between six and 12 months. Aprepitant was well tolerated and treatment-associated adverse events were similar to those described in the treatment of nausea. Clinical status at six and 12 months' follow-up did not differ between aprepitant and placebo groups. Post-treatment EEG scores at 12 months were better in the aprepitant group (P = 0.015). Cerebral atrophy on magnetic resonance imaging increased in both groups, whereas measles-specific immunoglobulin G index decreased in the placebo group.
CONCLUSIONS


In this first clinical trial of aprepitant treatment in patients with subacute sclerosing panencephalitis, the drug was safe and well tolerated. No clinical effect was observed. A modest improvement in EEG findings might justify trials for longer periods because EEG changes can precede clinical findings in subacute sclerosing panencephalitis.",2020,Post-treatment EEG scores at 12 months were better in the aprepitant group (P = 0.015).,"['Sixty-two patients with subacute sclerosing panencephalitis', 'patients with subacute sclerosing panencephalitis', 'Subacute Sclerosing Panencephalitis', 'Fifteen patients left the study within the first six\xa0months and 12 patients left between six and 12\xa0months']","['Placebo', 'aprepitant 250\xa0mg/day orally or placebo', 'placebo']","['Cerebral atrophy on magnetic resonance imaging', 'safety and efficacy', 'safety and tolerability, and secondary end point was clinical improvement or stabilization assessed by subacute sclerosing panencephalitis scoring system', 'measles-specific immunoglobulin G index', 'tolerated and treatment-associated adverse events', 'Electroencephalography (EEG), brain magnetic resonance imaging, and cerebrospinal fluid measles-specific immunoglobulin G index', 'nausea', 'safe and well tolerated']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038522', 'cui_str': 'Subacute sclerosing panencephalitis'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038522', 'cui_str': 'Subacute sclerosing panencephalitis'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0025007', 'cui_str': 'Measles'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",62.0,0.342205,Post-treatment EEG scores at 12 months were better in the aprepitant group (P = 0.015).,"[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Oncel', 'Affiliation': 'Department of Pediatric Neurology, Hacettepe University, Ankara, Turkey. Electronic address: dribrahimoncel@gmail.com.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Sancar', 'Affiliation': 'Faculty of Pharmacy, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Bahadir', 'Initials': 'B', 'LastName': 'Konuskan', 'Affiliation': 'Department of Pediatric Neurology, Hacettepe University, Ankara, Turkey; Pediatric Neurology Clinic, Ministry of Health Mardin Public Hospital, Mardin, Turkey.'}, {'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Arioz', 'Affiliation': 'Analytic Chemistry, Istanbul, Turkey.'}, {'ForeName': 'Songul', 'Initials': 'S', 'LastName': 'Tezcan', 'Affiliation': 'Faculty of Pharmacy, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arman-Kandirmaz', 'Affiliation': 'School of Applied Disciplines, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Safak', 'Initials': 'S', 'LastName': 'Parlak', 'Affiliation': 'Department of Radiology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ekim', 'Initials': 'E', 'LastName': 'Gumeler', 'Affiliation': 'Department of Radiology, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Anlar', 'Affiliation': 'Department of Pediatric Neurology, Hacettepe University, Ankara, Turkey.'}]",Pediatric neurology,['10.1016/j.pediatrneurol.2020.05.009']
1513,31604088,Development and initial validation of the Asthma Severity Scoring System (ASSESS).,"BACKGROUND


Tools for quantification of asthma severity are limited.
OBJECTIVE


We sought to develop a continuous measure of asthma severity, the Asthma Severity Scoring System (ASSESS), for adolescents and adults, incorporating domains of asthma control, lung function, medications, and exacerbations.
METHODS


Baseline and 36-month longitudinal data from participants in phase 3 of the Severe Asthma Research Program (NCT01606826) were used. Scale properties, responsiveness, and a minimally important difference were determined. External replication was performed in participants enrolled in the Severe Asthma Research Program phase 1/2. The utility of ASSESS for detecting treatment response was explored in participants undergoing corticosteroid responsiveness testing with intramuscular triamcinolone and participants receiving biologics.
RESULTS


ASSESS scores ranged from 0 to 20 (8.78 ± 3.9; greater scores reflect worse severity) and differed among 5 phenotypic groups. Measurement properties were acceptable. ASSESS was responsive to changes in quality of life with a minimally important difference of 2, with good specificity for outcomes of asthma improvement and worsening but poor sensitivity. Replication analyses yielded similar results, with a 2-point decrease (improvement) associated with improvements in quality of life. Participants with a 2-point or greater decrease (improvement) in ASSESS scores also had greater improvement in lung function and asthma control after triamcinolone, but these differences were limited to phenotypic clusters 3, 4, and 5. Participants treated with biologics also had a 2-point or greater decrease (improvement) in ASSESS scores overall.
CONCLUSIONS


The ASSESS tool is an objective measure that might be useful in epidemiologic and clinical research studies for quantification of treatment response in individual patients and phenotypic groups. However, validation studies are warranted.",2020,"Participants with a 2-point or greater decrease (improvement) in ASSESS scores also had greater improvement in lung function and asthma control after triamcinolone, but these differences were limited to phenotypic clusters 3, 4, and 5.","['Baseline and 36-month longitudinal data from participants in phase 3 of the Severe Asthma Research Program (NCT01606826) were used', 'adolescents and adults, incorporating domains of asthma control, lung function, medications, and exacerbations', 'participants undergoing corticosteroid responsiveness testing with intramuscular triamcinolone and participants receiving biologics', 'participants enrolled in the Severe Asthma Research Program phase 1/2']",['triamcinolone'],"['quality of life', 'lung function and asthma control']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0707634,"Participants with a 2-point or greater decrease (improvement) in ASSESS scores also had greater improvement in lung function and asthma control after triamcinolone, but these differences were limited to phenotypic clusters 3, 4, and 5.","[{'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': ""Department of Pediatrics, Emory University, Atlanta, Ga; Children's Healthcare of Atlanta, Atlanta, Ga. Electronic address: anne.fitzpatrick@emory.edu.""}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colo.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Mauger', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa.'}, {'ForeName': 'Brenda R', 'Initials': 'BR', 'LastName': 'Phillips', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pa.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Moore', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Sorkness', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, Wis.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Gergen', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, Md.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Internal Medicine, Washington University, St Louis, Mo.'}, {'ForeName': 'Serpil C', 'Initials': 'SC', 'LastName': 'Erzurum', 'Affiliation': 'Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Fahy', 'Affiliation': 'Department of Medicine, San Francisco, Calif.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Gaston', 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Levy', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Meyers', 'Affiliation': 'College of Medicine, University of Arizona, Tucson, Ariz.'}, {'ForeName': 'W Gerald', 'Initials': 'WG', 'LastName': 'Teague', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Va.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Department of Pediatrics, Washington University, St Louis, Mo.'}, {'ForeName': 'Ngoc P', 'Initials': 'NP', 'LastName': 'Ly', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, Cleveland, Ohio.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Immunology, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Kristie R', 'Initials': 'KR', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Zein', 'Affiliation': 'Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Nizar N', 'Initials': 'NN', 'LastName': 'Jarjour', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, Wis.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.09.018']
1514,32725642,The minimum clinically important difference on the sleep disorders inventory for people with dementia.,"OBJECTIVES


Sleep disturbances in dementia causes distress to people with dementia and their family carers and are associated with care home admission. The Sleep Disorders Inventory (SDI) is a validated questionnaire of sleep disturbances in dementia often used to measure treatment effectiveness, but the minimum clinically important difference (MCID) is unknown.
METHODS


We triangulated three investigative methods to determine the MCID of the SDI. Using data on SDI from a randomised controlled trial (RCT) with 62 participants in an intervention for sleep disorders in dementia, we (1) calculated distribution-based values where MCID = 0.33 of a SD (SD) (2) an anchor based approach using quality of life (measured using DEMQOL-Proxy) as an anchor. We also employed a Delphi consensus process asking 12 clinicians, sleep researchers and family carers to rate which changes on vignettes were equivalent to a MCID.
RESULTS


We found that 0.33 SD in the SDI = 4.86. Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = -0.01; P = 0.96) score. The Delphi consensus required two rounds to reach a consensus and concluded that changes equivalent to three points on the SDI equated to the MCID.
CONCLUSIONS


Taking into account both the distribution-based values and the Delphi process we used a whole number at the midpoint and judged the minimum clinically important difference MCID to be equal to four points. We note the clinicians and carers opinions from the Delphi process determined the MCID to be lower at three points.",2020,Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = ,"['dementia causes distress to people with dementia and their family carers', 'People with Dementia', '62 participants in an intervention for sleep disorders in dementia, we (1) calculated distribution-based values where MCID\xa0=\xa00.33 of a SD (SD) (2) an anchor based approach using']",[],"['quality of life', 'Sleep Disorders Inventory', 'SDI total score', 'Sleep Disorders Inventory (SDI']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",62.0,0.0608141,Reduction in SDI total score was not significantly correlated with improvement in DEMQOL-Proxy (Pearson's correlation = ,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Webster', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, UCL, Maple House, London, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, UCL, Maple House, London, UK.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Livingston', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, UCL, Maple House, London, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5384']
1515,32721578,The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods.,"BACKGROUND


Data addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH 3  and ambient PM 2.5  and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community.
OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  We investigated the effect of this enriched approach on these exposures and asthma health measures.
DESIGN


We randomized children with poorly controlled asthma to a control arm (current asthma education program) or an intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home). Outcomes included (1) 14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics at baseline, midpoint (4-6 months) and one-year follow-up. These included the Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration.
DISCUSSION


To our knowledge, this is the first randomized HEPA cleaner intervention designed to assess NH 3  as well as PM 2.5  and to evaluate health outcomes of children with asthma in an agricultural region.",2020,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","['children with asthma in rural U.S. communities', 'children with asthma in an agricultural region', 'children with poorly controlled asthma to a control arm (current asthma education program) or an']","[""intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home""]","['14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics', 'Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337099', 'cui_str': 'Air contaminant'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0221442,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Masterson', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: emaster@uw.edu.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Younglove', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': ""Yakima Valley Farm Worker's Clinic, Toppenish, WA, United States of America.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Torres', 'Affiliation': 'Northwest Communities Education Center, Radio KDNA, Granger, WA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Krenz', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tchong French', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Riederer', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sampson', 'Affiliation': 'Department of Statistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Min', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Aisenberg', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Babadi', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Farquhar', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Health Services, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Karr', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Pediatrics, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106085']
1516,32721845,Implementation of magnesium sulphate as an adjunct to multimodal analgesic approach for perioperative pain control in lumbar laminectomy surgery: A randomized placebo-controlled clinical trial.,"OBJECTIVE


To investigate the effect of systemic intraoperative administration of magnesium sulphate when used in the context of a multimodal pain management plan on analgesics consumption and pain scores, and perioperative outcomes after lumbar laminectomy surgery.
METHODS


Seventy-four patients undergoing lumbar laminectomy were enrolled in this randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to receive magnesium (20 mg/kg iv given as bolus before anesthesia induction followed by 20 mg/kg/h civ until surgery completion) or saline. Hemodynamic variables and desflurane consumption were noted at predefined time-intervals intraoperatively. Primary outcome was postoperative cumulative analgesic consumption over 24 h, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24 h), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points.
RESULTS


Demographics, surgery duration, desflurane requirements, and recovery profile were comparable between groups. Magnesium attenuated hemodynamic response during incision and emergence from anesthesia. Postoperative analgesics consumption in morphine iv equivalents (mean difference -9.24 [95 %CI -13.31, -5.17] mg; p = 0.001) and VAS scores at all-time points of assessment were lower in magnesium group; this effect peaked at 4 h (mean difference -2.15 [95 %CI -3.21,-1.09; p = 0.001]. Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01). No notable adverse effects were recorded.
CONCLUSION


It occurs that magnesium infusion during lumbar laminectomy surgery potentiates perioperative analgesia and reduces analgesic requirements up to 24 h postoperatively. No profound adverse effect on either intraoperative hemodynamics or any other clinically relevant endpoints becomes evident.",2020,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"['lumbar laminectomy surgery', 'Seventy-four patients undergoing lumbar laminectomy']","['Magnesium', 'placebo', 'magnesium (20\u202fmg/kg iv given as bolus before anesthesia induction followed by 20\u202fmg/kg/h civ until surgery completion) or saline', 'magnesium sulphate', 'magnesium', 'morphine']","['adverse effects', 'time-interval to first rescue analgesia', 'intraoperative remifentanil consumption', 'analgesics consumption and pain scores, and perioperative outcomes', 'postoperative cumulative analgesic consumption over 24\u202fh, while pain intensity (assessed by Visual Analogue Scale [VAS] at 1, 2, 4, 6 and 24\u202fh), intraoperative hemodynamics and opioid requirements, recovery profile, time to first analgesic request, and adverse effects constituted secondary end-points', 'analgesic requirements', 'hemodynamic response', 'Postoperative analgesics consumption', 'Hemodynamic variables and desflurane consumption', 'Demographics, surgery duration, desflurane requirements, and recovery profile', 'VAS scores']","[{'cui': 'C1112614', 'cui_str': 'Lumbar laminectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320755', 'cui_str': 'mg/kg/hr'}, {'cui': 'C0022326', 'cui_str': 'Ivory Coast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.791883,Magnesium reduced intraoperative remifentanil consumption and prolonged the time-interval to first rescue analgesia (p < 0.01).,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Tsaousi', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: tsaousig@otenet.gr.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Nikopoulou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: anastasian1991@windowslive.com.'}, {'ForeName': 'Ioakeim', 'Initials': 'I', 'LastName': 'Pezikoglou', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: makispez@gmail.com.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Birba', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: bsbvasso@yahoo.gr.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Grosomanidis', 'Affiliation': 'Department of Anesthesiology and ICU, Aristotle University Thessaloniki, University Campus, 54124, Thessaloniki, Greece. Electronic address: grosoman@otenet.gr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106091']
1517,32729273,Effects of Remote Ischemic Pre-Conditioning to Prevent Contrast-Induced Nephropathy after Intravenous Contrast Medium Injection: A Randomized Controlled Trial.,"OBJECTIVE


We aimed to assess the effects of remote ischemic pre-conditioning (RIPC) on the incidence of contrast-induced nephropathy (CIN) after an intravenous (IV) or intra-arterial injection of contrast medium (CM) in patient and control groups.
MATERIALS AND METHODS


This prospective, randomized, single-blinded, controlled trial included 26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six. All the patients underwent four cycles of five minute-blood pressure cuff inflation followed by five minutes of total deflation. In the RIPC group (n = 13), the cuff was inflated to 50 mm Hg above the patient's systolic blood pressure (SBP); in the control group (n = 13), it was inflated to 10 mm Hg below the patient's SBP. The primary endpoint was the occurrence of CIN. Additionally, variation in the serum levels of cystatin C was assessed.
RESULTS


One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients). Mean creatinine values at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 88 ± 32 μmol/L, 91 ± 28 μmol/L and 82 ± 29 μmol/L, respectively ( p  = 0.73) in the RIPC group, whereas in the control group, they were 100 ± 36 μmol/L, 110 ± 36 μmol/L, and 105 ± 34 μmol/L, respectively ( p  = 0.78). Cystatin C values (median [Q1, Q3]) at the baseline, 24 hours after injection of CM, and 48 hours after injection of CM were 1.10 [1.08, 1.18] mg/L, 1.17 [0.97, 1.35] mg/L, and 1.12 [0.99, 1.24] mg/L, respectively ( p  = 0.88) in the RIPC group, whereas they were 1.11 [0.97, 1.28] mg/L, 1.13 [1.08, 1.25] mg/L, and 1.16 [1.03, 1.31] mg/L, respectively ( p  = 0.93), in the control group.
CONCLUSION


The risk of CIN after an IV injection of CM is very low in patients with Mehran risk score greater than or equal to six and even in the patients who are unable to receive preventive hyperhydration. Hence, the Mehran risk score may not be an appropriate method for the estimation of the risk of CIN after IV CM injection.",2020,"One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients).","['patient and control groups', '26 patients who were hospitalized for the evaluation of the feasibility of transcatheter aortic valve implantation and underwent investigations including contrast-enhanced computed tomography (CT), with Mehran risk scores greater than or equal to six']","['Intravenous Contrast Medium Injection', 'remote ischemic pre-conditioning (RIPC', 'intravenous (IV) or intra-arterial injection of contrast medium (CM', 'Remote Ischemic Pre-Conditioning']","['incidence of contrast-induced nephropathy (CIN', 'Mean creatinine values', 'Cystatin C values (median [Q1, Q3', 'serum levels of cystatin C', 'CIN', 'occurrence of CIN', 'systolic blood pressure (SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439091', 'cui_str': '>='}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0021487', 'cui_str': 'Intra-arterial injection'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",26.0,0.0690735,"One case of CIN was observed in the control group, whereas no cases were detected in the RIPC group ( p  = 0.48, analysis of 25 patients).","[{'ForeName': 'Dihia', 'Initials': 'D', 'LastName': 'Belabbas', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Koch', 'Affiliation': 'Department of Radiodology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Ségolène', 'Initials': 'S', 'LastName': 'Chaudru', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Lederlin', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Laviolle', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Le Pabic', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boulmier', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Jean François', 'Initials': 'JF', 'LastName': 'Heautot', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Mahe', 'Affiliation': 'Vascular Medicine Unit, Department of Radiology, University Hospital Pontchaillou, Rennes, France. maheguillaume@yahoo.fr.'}]",Korean journal of radiology,['10.3348/kjr.2019.0916']
1518,32729275,Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial.,"OBJECTIVE


To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs).
MATERIALS AND METHODS


In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator.
RESULTS


Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585). No procedural or post-procedural complications were identified.
CONCLUSION


Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.",2020,There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585).,"['39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis', 'Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas', 'n = 19, PBA group) between June 2016 and June 2018', 'dysfunctional radiocephalic arteriovenous fistulas (RCAVFs']","['Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty', 'drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA', 'DBA and PBA', 'Paclitaxel-coated balloon', 'PBA alone']","['Technical and clinical success rates', 'mean duration of TLPP', 'No procedural or post-procedural complications', 'TLPP or TLSP', 'technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}]","[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1141930', 'cui_str': 'Post procedural complication'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",39.0,0.0701242,There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months;  p  = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months;  p  = 0.585).,"[{'ForeName': 'Jong Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea. ho7ok7@gilhospital.com.'}, {'ForeName': 'Sung Su', 'Initials': 'SS', 'LastName': 'Byun', 'Affiliation': 'Health Promotion Center, Inha University Hospital, Incheon, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Ji Hoon', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Korean journal of radiology,['10.3348/kjr.2020.0067']
1519,32729923,Nitrate-Rich Beetroot Juice Reduces Blood Pressure in Tanzanian Adults with Elevated Blood Pressure: A Double-Blind Randomized Controlled Feasibility Trial.,"BACKGROUND


In Sub-Saharan Africa, current strategies are struggling to control the burgeoning hypertension epidemic. Dietary interventions such as inorganic nitrate or folic acid supplementation could represent promising strategies for reducing blood pressure (BP) in this setting.
OBJECTIVES


This feasibility study explores the effects of dietary inorganic nitrate supplementation, alone or in combination with folic acid, on BP in Tanzanian adults with elevated BP in Tanzania.
METHODS


A placebo-controlled, double-blind, randomized controlled feasibility trial was conducted. Forty-seven middle-aged and older participants (age: 50-70 y, BMI: 26.3-29.1 kg/m2) were randomly assigned to 3 conditions for a period of 60 d: 1) high-nitrate beetroot juice (∼400 mg nitrate) and folic acid (∼5 mg folic acid) (N + F), 2) high-nitrate beetroot juice and placebo (N + P), or 3) nitrate-depleted beetroot juice and placebo (P + P). Clinic and 24-h ambulatory BP and measurements of compliance in plasma (nitrate and folate concentrations) and saliva (nitrate and nitrite) were obtained at baseline, 30 d, and 60 d.
RESULTS


Baseline resting systolic and diastolic BP (mean ± SD) was 151.0 ± 19.4 mm Hg and 91.8 ± 11.7 mm Hg, respectively. Compliance to the interventions was high (>90%) in all groups which was confirmed by the significant increase in nitrate and folic acid concentrations in plasma and saliva samples in the treatment arms. After 60 d, 24-h systolic BP dropped by -10.8 ± 9.8 mm Hg (P < 0.001), -6.1 ± 13.2 mm Hg (P = 0.03), and -0.3 ± 9.7 mm Hg (P = 0.83) in the N + P, N + F, and P + P groups, respectively. There was a significant decrease in 24-h diastolic BP in the N + P group (-5.4 ± 5.0 mm Hg, P = 0.004), whereas changes were not significant in the N + F (-1.8 ± 8.1 mm Hg, P = 0.32) and P + P (1.6 ± 8.3 mm Hg, P = 0.43) groups.
CONCLUSIONS


Dietary inorganic nitrate represents a potential nutritional strategy to lessen the hypertension epidemic in Sub-Saharan Africa. These findings support the rationale for future long-term investigations exploring the efficacy of dietary nitrate for lowering BP and attenuating cardiovascular disease risk in this setting.This trial was registered at isrctn.com as ISRCTN67978523.",2020,Compliance to the interventions was high (>90%) in all groups which was confirmed by the significant increase in nitrate and folic acid concentrations in plasma and saliva samples in the treatment arms.,"['Forty-seven middle-aged and older participants (age: 50-70 y, BMI: 26.3-29.1\xa0kg/m2', 'Tanzanian adults with elevated BP in Tanzania', 'Tanzanian Adults with Elevated Blood Pressure']","['inorganic nitrate or folic acid supplementation', 'high-nitrate beetroot juice (∼400\xa0mg nitrate) and folic acid (∼5\xa0mg folic acid', 'Nitrate-Rich Beetroot Juice', 'Dietary inorganic nitrate', 'nitrate-depleted beetroot juice and placebo', 'dietary inorganic nitrate supplementation, alone or in combination with folic acid', 'placebo']","['Baseline resting systolic and diastolic BP (mean ± SD', '24-h diastolic BP', 'nitrate and folic acid concentrations in plasma and saliva samples', 'blood pressure (BP', '24-h systolic BP', 'Clinic and 24-h ambulatory BP and measurements of compliance in plasma (nitrate and folate concentrations) and saliva (nitrate and nitrite', 'Blood Pressure']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}]",,0.369246,Compliance to the interventions was high (>90%) in all groups which was confirmed by the significant increase in nitrate and folic acid concentrations in plasma and saliva samples in the treatment arms.,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Siervo', 'Affiliation': 'School of Life Sciences, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Shannon', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle on Tyne, United Kingdom.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Kandhari', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle on Tyne, United Kingdom.'}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Prabhakar', 'Affiliation': 'Faculty of Medical Sciences, Newcastle University, Newcastle on Tyne, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Fostier', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle on Tyne, United Kingdom.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Köchl', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle on Tyne, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Rogathi', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Temu', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Blossom C M', 'Initials': 'BCM', 'LastName': 'Stephan', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Gray', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Haule', 'Affiliation': 'District Medical Officer, Hai District Hospital, Bomangombe, Tanzania.'}, {'ForeName': 'Stella-Maria', 'Initials': 'SM', 'LastName': 'Paddick', 'Affiliation': 'Clinical and Translational Medicine, Newcastle University, Newcastle on Tyne, United Kingdom.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa170']
1520,32726873,Impact of WeChat-based 'three good things' on turnover intention and coping style in burnout nurses.,"BACKGROUND


Few studies have considered functions of nurses' positive personality and behaviours on addressing their turnover intention.
AIMS


To explore the effects of WeChat-based 'three good things' (3GT) on burnout nurses' turnover intention and coping styles.
METHODS


A randomized controlled trial. 73 nurses were included in the intervention group (n = 33) and the control group (n = 40). The intervention group received WeChat-based 3GT. Turnover intention and coping style were measured before and after the intervention.
RESULTS


WeChat-based 3GT effectively reduced turnover intention and negative coping style (each p < .05). Positive coping style was promoted after the intervention (p < .05). Time effects as well as intervention and time interactions were significant in turnover intention and negative coping style (each p < .05).
CONCLUSION


Benefits of WeChat-based 3GT on turnover intention and coping style in burnout nurses were found. Nurses experienced lower levels of turnover intention and negative coping style and increased the usage of positive coping style after the intervention.
IMPLICATIONS FOR NURSING MANAGEMENT


Nurse managers should incorporate 3GT intervention with popular social communication programmes to improve nurses' coping strategies towards clinical issues and maintain the stability of nursing teams.",2020,"RESULTS


WeChat-based 3GT effectively reduced turnover intention and negative coping style (each p < 0.05).",['73 nurses were included in the intervention group (n = 33) and the control group (n = 40'],"['WeChat-based ""three good things"" (3GT', 'WeChat-based 3GT', 'WeChat-Based ""Three Good Things']","['usage of positive coping style', 'Turnover Intention and Coping Style', 'Turnover intention and coping style', 'Positive coping style', 'turnover intention and coping style', 'turnover intention and negative coping style']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.0277152,"RESULTS


WeChat-based 3GT effectively reduced turnover intention and negative coping style (each p < 0.05).","[{'ForeName': 'Yu-Fang', 'Initials': 'YF', 'LastName': 'Guo', 'Affiliation': 'School of Nursing, ShanDong University, Jinan, China.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Plummer', 'Affiliation': 'School of Nursing and Midwifery, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Vic., Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cross', 'Affiliation': 'School of Health, Federation University Australia, Berwick, Vic., Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'School of Health, Federation University Australia, Berwick, Vic., Australia.'}, {'ForeName': 'Jing-Ping', 'Initials': 'JP', 'LastName': 'Zhang', 'Affiliation': 'Nursing Psychology Research Center of Xiangya Nursing School, Central South University, Changsha, China.'}]",Journal of nursing management,['10.1111/jonm.13111']
1521,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1522,32758689,"SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.","BACKGROUND


The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial.
METHODS


In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited viral replication (EC 50 =1.02ng/ml), and prevented viral infection (EC 50 =0.10ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p=0.0400, and 60.0% vs. 24.1%, p=0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
1523,32762272,The effects of acute cannabidiol on cerebral blood flow and its relationship to memory: An arterial spin labelling magnetic resonance imaging study.,"BACKGROUND


Cannabidiol (CBD) is being investigated as a potential treatment for several medical indications, many of which are characterised by altered memory processing. However, the mechanisms underlying these effects are unclear.
AIMS


Our primary aim was to investigate how CBD influences cerebral blood flow (CBF) in regions involved in memory processing. Our secondary aim was to determine if the effects of CBD on CBF were associated with differences in working and episodic memory task performance.
METHODS


We used a randomised, crossover, double-blind design in which 15 healthy participants were administered 600 mg oral CBD or placebo on separate days. We measured regional CBF at rest using arterial spin labelling 3 h after drug ingestion. We assessed working memory with the digit span (forward, backward) and n-back (0-back, 1-back, 2-back) tasks, and we used a prose recall task (immediate and delayed) to assess episodic memory.
RESULTS


CBD increased CBF in the hippocampus (mean (95% confidence intervals) = 15.00 (5.78-24.21) mL/100 g/min,  t 14  = 3.489, Cohen's  d  = 0.75,  p  = 0.004). There were no differences in memory task performance, but there was a significant correlation whereby greater CBD-induced increases in orbitofrontal CBF were associated with reduced reaction time on the 2-back working memory task (  r = -0.73,  p  = 0.005).
CONCLUSIONS


These findings suggest that CBD increases CBF to key regions involved in memory processing, particularly the hippocampus. These results identify potential mechanisms of CBD for a range of conditions associated with altered memory processing, including Alzheimer's disease, schizophrenia, post-traumatic stress disorder and cannabis-use disorders.",2020,"RESULTS


CBD increased CBF in the hippocampus (mean (95% confidence intervals) = 15.00 (5.78-24.21) mL/100 ",['15 healthy participants'],"['600\u2009mg oral CBD or placebo', 'CBD']","['working and episodic memory task performance', 'working memory with the digit span (forward, backward) and n-back (0-back, 1-back, 2-back) tasks', 'orbitofrontal CBF', 'memory task performance', 'regional CBF', 'reduced reaction time on the 2-back working memory task', 'cerebral blood flow and its relationship to memory', 'CBF', 'cerebral blood flow (CBF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",15.0,0.313018,"RESULTS


CBD increased CBF in the hippocampus (mean (95% confidence intervals) = 15.00 (5.78-24.21) mL/100 ","[{'ForeName': 'Michael A P', 'Initials': 'MAP', 'LastName': 'Bloomfield', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Green', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Yumeya', 'Initials': 'Y', 'LastName': 'Yamamori', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Jocelyn Lok Ling', 'Initials': 'JLL', 'LastName': 'Yim', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Augustus P M', 'Initials': 'APM', 'LastName': 'Jones', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Walker', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Tokarczuk', 'Affiliation': 'Medical Research Council London Institute of Medical Sciences, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Statton', 'Affiliation': 'Medical Research Council London Institute of Medical Sciences, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'Oliver D', 'Initials': 'OD', 'LastName': 'Howes', 'Affiliation': 'Psychiatric Imaging Group, Medical Research Council London Institute of Medical Sciences, Imperial College London, Hammersmith Hospital, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': 'Translational Psychiatry Research Group, Research Department of Mental Health Neuroscience, Division of Psychiatry, Institute of Mental Health, University College London, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120936419']
1524,32763086,Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention.,"INTRODUCTION


Hypoglycaemia is one of the most serious adverse effects of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in studies that evaluate the impact of such type of interventions on hypoglycaemia risk in elderly patients with type 2 diabetes. The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
METHODS


and analysis: This study is an open-label, parallel controlled randomised trial, which will be conducted in the outpatient clinics at the largest referral hospital in the north of Jordan. Participants who are elderly (age ≥ 65 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications will be randomly assigned to intervention (SUGAR Handshake) and control (usual care) groups. The SUGAR Handshake participants will have an interactive, individualised, medications-focused counselling session reinforced with a pictogram and a phone call at week six of enrolment. The primary outcome measure is the frequency of total hypoglycaemic events within 12 weeks of follow up. Secondary outcomes include the frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack. We will also conduct a nested qualitative study for process evaluation.
ETHICS AND DISSEMINATION


The Human Research Ethics Committee of the University of Lincoln and the Institutional Review Board of King Abdullah University Hospital approved this protocol. The findings of this study will be presented in international conferences and published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


The study protocol has been registered with ClinicalTrials.gov, NCT04081766.",2020,"The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
","['elderly patients with type 2 diabetes', 'older adults with type 2 diabetes mellitus', 'Older adults', 'outpatient clinics at the largest referral hospital in the north of Jordan', 'older adults with type 2 diabetes mellitus (ROSE-ADAM', 'Participants who are elderly (age\xa0≥\xa065 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications']","['SUGAR intervention', 'pharmacist-led patient counselling']","['frequency of total hypoglycaemic events', 'frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack', 'hypoglycaemic attacks', 'hypoglycaemia risk', 'Hypoglycaemia']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0600047', 'cui_str': 'Patient counseled'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.12039,"The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
","[{'ForeName': 'Huda Y', 'Initials': 'HY', 'LastName': 'Almomani', 'Affiliation': 'School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK. Electronic address: huda.almomani@yahoo.com.'}, {'ForeName': 'Carlos Rodriguez', 'Initials': 'CR', 'LastName': 'Pascual', 'Affiliation': 'School of Pharmacy, University of Lincoln, LN6 7DL, Lincoln, UK.'}, {'ForeName': 'Sayer I', 'Initials': 'SI', 'LastName': 'Al-Azzam', 'Affiliation': 'Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, 22110, Jordan.'}, {'ForeName': 'Keivan', 'Initials': 'K', 'LastName': 'Ahmadi', 'Affiliation': 'Lincoln Medical School, Universities of Nottingham and Lincoln, University of Lincoln, LN6 7TS, Lincoln, UK.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.07.012']
1525,32725107,Predictors of recurrence of atrial fibrillation within the first 3 months after ablation.,"AIMS


Freedom from atrial fibrillation (AF) at 1 year can be achieved in 50-70% of patients undergoing catheter ablation. Recurrent AF early after ablation most commonly terminates spontaneously without further interventional treatment but is associated with later recurrent AF. The aim of this investigation is to identify clinical and procedural factors associated with recurrence of AF early after ablation.
METHODS AND RESULTS


We retrospectively analysed data for recurrence of AF within the first 3 months after catheter ablation from the randomized controlled AXAFA-AFNET 5 trial, which demonstrated that continuous anticoagulation with apixaban is as safe and as effective compared to vitamin K antagonists in 678 patients undergoing first AF ablation. The primary outcome of first recurrent AF within 90 days was observed in 163 (28%) patients, in which 78 (48%) patients experienced an event within the first 14 days post-ablation. After multivariable adjustment, a history of stroke/transient ischaemic attack [hazard ratio (HR) 1.54, 95% confidence interval (CI) 0.93-2.6; P = 0.11], coronary artery disease (HR 1.85, 95% CI 1.20-2.86; P = 0.005), cardioversion during ablation (HR 1.78, 95% CI 1.26-2.49; P = 0.001), and an age:sex interaction for older women (HR 1.01, 95% CI 1.00-1.01; P = 0.04) were associated with recurrent AF. The P-wave duration at follow-up was significantly longer for patients with AF recurrence (129 ± 31 ms vs. 122 ± 22 ms in patients without AF, P = 0.03).
CONCLUSION


Half of all early AF recurrences within the first 3 months post-ablation occurred within the first 14 days post-ablation. Vascular disease and cardioversion during the procedure are strong predictors of recurrent AF. P-wave duration at follow-up was longer in patients with recurrent AF.
TRIAL REGISTRATION


Clinicaltrials.gov identifier NCT02227550.",2020,The P-wave duration at follow-up was significantly longer for patients with AF recurrence (129 ± 31 ,"['678 patients undergoing first AF ablation', 'patients with AF recurrence (129\u2009±\u200931']","['apixaban', 'vitamin K antagonists']","['recurrence of atrial fibrillation', 'coronary artery disease', 'Vascular disease and cardioversion', 'history of stroke/transient ischaemic attack', 'first recurrent AF within 90\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0741282', 'cui_str': 'Recurrent atrial fibrillation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",678.0,0.0706953,The P-wave duration at follow-up was significantly longer for patients with AF recurrence (129 ± 31 ,"[{'ForeName': 'Matthias Daniel', 'Initials': 'MD', 'LastName': 'Zink', 'Affiliation': 'Department of Internal Medicine I, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Chua', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Stef', 'Initials': 'S', 'LastName': 'Zeemering', 'Affiliation': 'Department of Physiology, Cardiovascular Research Institute Maastricht (CARIM), Universiteitsingel 50, 6229 ER Maastricht, Netherlands.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'di Biase', 'Affiliation': 'Department of Medicine (Cardiology), Albert Einstein College of Medicine at Montefiore Hospital, Montefiore-Einstein Center for Heart & Vascular Care New York, NY, USA.'}, {'ForeName': 'Bayes de Luna', 'Initials': 'BL', 'LastName': 'Antoni', 'Affiliation': 'Autonomous University of Barcelona and Institut Català Ciències Cardiovasculars (ICCC)-St. Pau Hospital, Barcelona, Spain.'}, {'ForeName': 'Callans', 'Initials': 'C', 'LastName': 'David', 'Affiliation': 'Cardiology Division, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'University of Leipzig, Heart Center Leipzig, Leipzig, Germany.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Cardiac Electrophysiology, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Piccini', 'Affiliation': 'Department of Cardiac Electrophysiology, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Arrhythmia Section, Universitat de Barcelona, Hospital Clinic, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Jens Cosedis', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Escobar', 'Affiliation': 'Autonomous University of Barcelona and Institut Català Ciències Cardiovasculars (ICCC)-St. Pau Hospital, Barcelona, Spain.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'de Bono', 'Affiliation': 'Department of Cardiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Department of Cardiology and Thorax Surgery, UMCG Thorax Center, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'de Potter', 'Affiliation': 'Department of Cardiology, Electrophysiology section, Cardiovascular Center, OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Scherr', 'Affiliation': 'Department of Physiology, Cardiovascular Research Institute Maastricht (CARIM), Universiteitsingel 50, 6229 ER Maastricht, Netherlands.'}, {'ForeName': 'Sakis', 'Initials': 'S', 'LastName': 'Themistoclakis', 'Affiliation': ""Unit of Electrophysiology and Cardiac Pacing, Dell'Angelo Hospital, Mestre-Venice, Italy.""}, {'ForeName': 'Derick', 'Initials': 'D', 'LastName': 'Todd', 'Affiliation': 'Department of EP, Devices and ICC, Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schotten', 'Affiliation': 'Department of Physiology, Cardiovascular Research Institute Maastricht (CARIM), Universiteitsingel 50, 6229 ER Maastricht, Netherlands.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa132']
1526,32721549,High intensity interval training combined with L-citrulline supplementation: Effects on physical performance in healthy older adults.,"INTRODUCTION


The aim of this study was to evaluate the effect of citrulline (CIT) supplementation combined to high intensity interval training (HIIT) on physical performance in healthy older adults.
METHODS


This study is a secondary analysis from a double-blind, randomized trial. Among the participants (sedentary & inactive older adults aged over 65 yrs), 44 were non obese (BMI <30 kg/m 2 ) and completed the intervention: Placebo + HIIT (PLA; n = 21) or CIT + HIIT (n = 23). All participants ingested either 10 g of CIT supplementation/day or placebo and followed HIIT sessions (30 min/session; cycle: 30 s > 85% of maximal heart rate (HR) and Borg scale >17/20 + 1:50 min at 65% HR and Borg scale between 13 and 16) on an elliptical device 3 times per week over a 12-week period. Body composition, muscle strength, muscle power, functional capacities (unipodal balance; self-paced and fast Timed Up and Go (nTUG; fTUG); chair test; step tests; 4-meter walking test; 6-minute walking test); dietary intake, energy expenditure and biological markers were measured pre and post-intervention. A repeated-measure analysis of variance was used to estimate time (HIIT intervention), group (PLA vs. CIT) and time*group effects.
RESULTS


The decrease in BMI (p = 0.02) and android fat mass (p = 0.05) were significantly greater in the HIIT+CIT group than in the HIIT+PLA group. Finally, a greater increase in self-paced gait speed (nTUG) (p = 0.02) and fast-paced gait speed (fTUG) (p = 0.03) were also observed in the HIIT+CIT group than in the HIIT+PLA group.
CONCLUSION


CIT supplementation combined to HIIT is more effective in improving functional capacities and body composition in healthy older adults than HIIT alone.",2020,"Finally, a greater increase in self-paced gait speed (nTUG) (p = 0.02) and fast-paced gait speed (fTUG) (p = 0.03) were also observed in the HIIT+CIT group than in the HIIT+PLA group.
","['participants (sedentary & inactive older adults aged over 65\u202fyrs), 44 were non obese (BMI <30\u202fkg/m 2 ) and completed the intervention', 'healthy older adults']","['HIIT+CIT', 'citrulline (CIT) supplementation combined to high intensity interval training (HIIT', 'HIIT+PLA', 'CIT supplementation/day or placebo and followed HIIT sessions', 'CIT supplementation combined to HIIT', 'Placebo + HIIT (PLA; n\u202f=\u202f21) or CIT\u202f+\u202fHIIT', 'High intensity interval training combined with L-citrulline supplementation']","['Body composition, muscle strength, muscle power, functional capacities (unipodal balance; self-paced and fast Timed Up and Go (nTUG; fTUG); chair test; step tests; 4-meter walking test; 6-minute walking test); dietary intake, energy expenditure and biological markers', 'BMI', 'physical performance', 'self-paced gait speed (nTUG', 'fast-paced gait speed (fTUG', 'android fat mass', 'functional capacities and body composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",,0.15454,"Finally, a greater increase in self-paced gait speed (nTUG) (p = 0.02) and fast-paced gait speed (fTUG) (p = 0.03) were also observed in the HIIT+CIT group than in the HIIT+PLA group.
","[{'ForeName': 'Buckinx', 'Initials': 'B', 'LastName': 'F', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada; WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, Liège, Belgium.""}, {'ForeName': 'Carvalho', 'Initials': 'C', 'LastName': 'L P', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Marcangeli', 'Initials': 'M', 'LastName': 'V', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Dulac', 'Initials': 'D', 'LastName': 'M', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Hajj Boutros', 'Initials': 'HB', 'LastName': 'G', 'Affiliation': ""Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Gouspillou', 'Initials': 'G', 'LastName': 'G', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada.""}, {'ForeName': 'Gaudreau', 'Initials': 'G', 'LastName': 'P', 'Affiliation': ""Département de Médecine, Université de Montréal, Montréal, Canada; Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Canada.""}, {'ForeName': 'Noirez', 'Initials': 'N', 'LastName': 'P', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Inserm UMR S-1124 & IRMES EA7329, Université de Paris, Paris, France.""}, {'ForeName': 'Aubertin-Leheudre', 'Initials': 'AL', 'LastName': 'M', 'Affiliation': ""Département des Sciences de l'Activité Physique, GRAPA, Université du Québec À Montréal, Montréal, Canada; Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, Canada. Electronic address: aubertin-leheudre.mylene@uqam.ca.""}]",Experimental gerontology,['10.1016/j.exger.2020.111036']
1527,32729222,Combination therapy with pioglitazone/exenatide improves beta-cell function and produces superior glycaemic control compared with basal/bolus insulin in poorly controlled type 2 diabetes: A 3-year follow-up of the Qatar study.,"AIM


To examine the long-term efficacy of thiazolidinedione plus a glucagon-like peptide-1 receptor agonist versus basal-bolus insulin on glycaemic control and beta-cell function in patients with poorly controlled type 2 diabetes (T2D) on metformin plus sulphonylurea.
MATERIALS AND METHODS


Three hundred and thirty-one patients with poorly controlled T2D were recruited over 3 years and were followed for an additional year. Subjects received a 75 g oral glucose tolerance test (OGTT) at baseline and at study end. After completing the baseline OGTT, subjects were randomized to receive either pioglitazone plus weekly exenatide (combination therapy) or basal/bolus insulin (insulin therapy) to maintain an HbA1c of less than 7.0%. The primary outcome of the study was the difference in HbA1c at study end between the two treatment groups.
RESULTS


Both therapies caused a robust decrease in HbA1c. However, combination therapy caused a greater decrement (-1.1%, P < .0001) than insulin therapy, and more subjects in the combination therapy group (86%) achieved the American Diabetes Association goal of glycaemic control (HbA1c < 7.0%) than those in the insulin therapy group (44%) (P < .0001). Both therapies improved insulin secretion. However, the improvement in insulin secretion with combination therapy was 2.5-fold greater (P < .001) than with insulin therapy (50%). Insulin therapy caused more weight gain and hypoglycaemia.
CONCLUSION


Both combination therapy and insulin therapy effectively reduced HbA1c in poorly controlled T2D on multiple oral agents. However, combination therapy produced a greater improvement in insulin secretion and decrease in HbA1c with a lower risk of hypoglycaemia.",2020,"However, Combination Therapy caused a greater decrement (-1.1%, p<0.0001) than Insulin Therapy, and more subjects in the Combination Therapy group (86%) achieved the ADA goal of glycemic control, HbA1c<7.0% than in Insulin Therapy group (44%)","['331 poorly controlled T2DM patients were recruited over 3 years and followed for an additional one year', 'poorly controlled T2DM patients on metformin plus sulfonylurea']","['Insulin Therapy', 'Pioglitazone/Exenatide', 'thiazolidinedione plus GLP-1 RA', 'pioglitazone plus weekly exenatide (Combination Therapy), or (ii) basal/bolus insulin (Insulin Therapy) to maintain HbA1c <7.0']","['Beta Cell Function', 'ADA goal of glycemic control', 'glycemic control and beta cell function', 'insulin secretion', 'weight gain and hypoglycemia']","[{'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.0567023,"However, Combination Therapy caused a greater decrement (-1.1%, p<0.0001) than Insulin Therapy, and more subjects in the Combination Therapy group (86%) achieved the ADA goal of glycemic control, HbA1c<7.0% than in Insulin Therapy group (44%)","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Migahid', 'Affiliation': 'Academic Health System, Hamad General Hospital, Doha, Qatar.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Megahed', 'Affiliation': 'Academic Health System, Hamad General Hospital, Doha, Qatar.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Ebaa', 'Initials': 'E', 'LastName': 'Al-Ozairi', 'Affiliation': 'Dasman Diabetes Institute, Kuwait City, Kuwait.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Jayyousi', 'Affiliation': 'Academic Health System, Hamad General Hospital, Doha, Qatar.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14153']
1528,32729819,Bioequivalence study of two formulations of memantine hydrochloride tablets in healthy male Chinese subjects under fasting and fed conditions.,"PURPOSE


Memantine is currently the only drug that acts on the glutamate energy system to treat Alzheimer's disease. A generic memantine tablet was developed to offer an alternative to the marketed tablet formulation. The purpose of this study was to assess the bioequivalence of two different memantine formulations among healthy male Chinese subjects under fasting and fed conditions.
MATERIALS AND METHODS


We carried out single-center, randomized, single-dose, open-label, two-period, cross-over studies which including 20 healthy male Chinese subjects under fasting and fed conditions, respectively. Plasma samples were collected prior to and up to 240 hours after dosing. Key pharmacokinetic parameters including area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t ), area from time zero to infinite (AUC 0-∞ ), and C max  were used for bioequivalence assessment.
RESULTS


Under fasting condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 106.5 - 114.0% for C max , 99.4 - 107.9% for AUC 0-t , and 100.0 - 109.6% for AUC 0-∞ . Under fed condition, the 90% CIs of the geometric mean ratios of the test/reference drug for memantine were 94.8 - 104.3% for C max , 98.2 - 110.5% for AUC 0-t , and 99.2 - 113.0% for AUC 0-∞ .
CONCLUSION


The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state. That is to say, the test formulation of memantine 10-mg tablet is bioequivalent to the reference formulation (Ebixa 10-mg tablet).",2020,The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state.,"['20 healthy male Chinese subjects under fasting and fed conditions, respectively', 'healthy male Chinese subjects under fasting and fed conditions', 'healthy male Chinese subjects under fasting and fed conditions\u2029']","['memantine hydrochloride tablets', 'memantine', 'memantine formulations', 'Memantine']","['plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t ), area from time zero to infinite (AUC 0-∞ ), and C max', 'geometric mean ratios of the test/reference drug for memantine']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0771988', 'cui_str': 'Memantine hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]",20.0,0.0343325,The observed pharmacokinetic parameters of memantine of the test drug were similar to those of the reference formulation both in the fasting and fed state.,"[{'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Jiangying', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Mai', 'Affiliation': ''}, {'ForeName': 'Xiyong', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Zhong', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203683']
1529,32735145,Radiographic and clinical effects of 10 mg and 25 mg twice-weekly etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis.,"OBJECTIVES


To compare the radiographic and clinical effects of 25 versus 10 mg twice-weekly (BIW) etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis (RA).
METHODS


This was a  post-hoc  analysis of a Phase 3 study where Japanese patients with active RA were randomized to receive BIW etanercept 25 mg ( n  = 182), etanercept 10 mg ( n  = 192), or methotrexate ( n  = 176) for 52 weeks (NCT00445770). This analysis included assessments of week-24 and week-52 disease activity, week-52 radiographic progression, and the relationship between baseline characteristics and week 52 clinical outcomes with clinically relevant radiographic progression (CRRP) at week 52.
RESULTS


At week 52, there were no significant differences between 25 and 10 mg etanercept in terms of achieving low disease activity or remission. CRRP was observed in 36% and 32% of patients in the 10 and 25 mg groups, respectively. Predictor analysis suggested that worse background disease status, treatment with methotrexate rather than etanercept, and poorer clinical outcomes at week 52 were associated with CRRP.
CONCLUSIONS


The 25 mg BIW etanercept dosage does not appear to be significantly more efficacious than 10 mg in Japanese patients with RA. Further studies evaluating the optimal etanercept dosing regimen in this patient population may be merited. NCT: NCT00445770.",2020,"At week 52, there were no significant differences between 25 and 10 mg etanercept in terms of achieving low disease activity or remission.","['Japanese patients with active rheumatoid arthritis', 'Japanese patients with RA', 'Japanese patients with active RA', 'Japanese patients with active rheumatoid arthritis (RA']","['NCT', 'etanercept 10\u2009mg (n\u2009=\u2009192), or methotrexate', 'etanercept', 'methotrexate', '10\u2009mg and 25\u2009mg twice-weekly etanercept', 'BIW etanercept', '25 versus 10\u2009mg twice-weekly (BIW) etanercept']","['CRRP', 'low disease activity or remission']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0483493,"At week 52, there were no significant differences between 25 and 10 mg etanercept in terms of achieving low disease activity or remission.","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyasaka', 'Affiliation': 'Department of Medicine and Rheumatology, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Ron D', 'Initials': 'RD', 'LastName': 'Pedersen', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sugiyama', 'Affiliation': 'Clinical Statistics, Biometrics, and Data Management, Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Immunology & Inflammation Medical Affairs, Innovative Medicines Business, Pfizer Japan Inc, Tokyo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1805142']
1530,32730183,Rituximab-CHOP With Early Rituximab Intensification for Diffuse Large B-Cell Lymphoma: A Randomized Phase III Trial of the HOVON and the Nordic Lymphoma Group (HOVON-84).,"PURPOSE


Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become standard of care for patients with diffuse large B-cell lymphoma (DLBCL). This randomized trial assessed whether rituximab intensification during the first 4 cycles of R-CHOP could improve the outcome of these patients compared with standard R-CHOP.
PATIENTS AND METHODS


A total of 574 patients with DLBCL age 18 to 80 years were randomly assigned to induction therapy with 6 or 8 cycles of R-CHOP-14 with (RR-CHOP-14) or without (R-CHOP-14) intensification of rituximab in the first 4 cycles. The primary end point was complete remission (CR) on induction. Analyses were performed by intention to treat.
RESULTS


CR was achieved in 254 (89%) of 286 patients in the R-CHOP-14 arm and 249 (86%) of 288 patients in the RR-CHOP-14 arm (hazard ratio [HR], 0.82; 95% CI, 0.50 to 1.36;  P  = .44). After a median follow-up of 92 months (range, 1-131 months), 3-year failure-free survival was 74% (95% CI, 68% to 78%) in the R-CHOP-14 arm versus 69% (95% CI, 63% to 74%) in the RR-CHOP-14 arm (HR, 1.26; 95% CI, 0.98 to 1.61;  P  = .07). Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;  P  = .15). Overall survival at 3 years was 81% (95% CI, 76% to 85%) in the R-CHOP-14 arm versus 76% (95% CI, 70% to 80%) in the RR-CHOP-14 arm (HR, 1.27; 95% CI, 0.97 to 1.67;  P  = .09). Patients between ages 66 and 80 years experienced significantly more toxicity during the first 4 cycles in the RR-CHOP-14 arm, especially neutropenia and infections.
CONCLUSION


Early rituximab intensification during R-CHOP-14 does not improve outcome in patients with untreated DLBCL.",2020,"Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;  P  = .15).","['574 patients with DLBCL age 18 to 80 years', 'patients with untreated DLBCL', 'patients with diffuse large B-cell lymphoma (DLBCL', 'Large B-Cell Lymphoma']","['Immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP', 'Rituximab-CHOP With Early Rituximab']","['neutropenia and infections', 'Progression-free survival', 'Overall survival', 'toxicity', 'complete remission (CR) on induction', '3-year failure-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",574.0,0.114829,"Progression-free survival at 3 years was 74% (95% CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95% CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95% CI, 0.94 to 1.55;  P  = .15).","[{'ForeName': 'Pieternella Johanna', 'Initials': 'PJ', 'LastName': 'Lugtenburg', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Nully Brown', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Bronno', 'Initials': 'B', 'LastName': 'van der Holt', 'Affiliation': 'Haemato Oncology Foundation for Adults in the Netherlands (HOVON) Data Center, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Francesco A', 'Initials': 'FA', 'LastName': ""D'Amore"", 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Koene', 'Affiliation': 'St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'de Jongh', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Fijnheer', 'Affiliation': 'Meander MC, Amersfoort, the Netherlands.'}, {'ForeName': 'Joost W', 'Initials': 'JW', 'LastName': 'van Esser', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Lara H', 'Initials': 'LH', 'LastName': 'Böhmer', 'Affiliation': 'Haga Teaching Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Johannes F', 'Initials': 'JF', 'LastName': 'Pruijt', 'Affiliation': ""Jeroen Bosch Hospital, 's Hertogenbosch, the Netherlands.""}, {'ForeName': 'Gregor E', 'Initials': 'GE', 'LastName': 'Verhoef', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Medical Center Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'Memis Y', 'Initials': 'MY', 'LastName': 'Bilgin', 'Affiliation': 'Admiraal de Ruijter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Nijland', 'Affiliation': 'University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'van der Burg-de Graauw', 'Affiliation': 'Bravis Hospital, Roosendaal, the Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Oosterveld', 'Affiliation': 'Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}, {'ForeName': 'Kon-Siong G', 'Initials': 'KG', 'LastName': 'Jie', 'Affiliation': 'Zuyderland Medical Center, Heerlen, the Netherlands.'}, {'ForeName': 'Thomas Stauffer', 'Initials': 'TS', 'LastName': 'Larsen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Marjolein W', 'Initials': 'MW', 'LastName': 'van der Poel', 'Affiliation': 'Maastricht University MC, Maastricht, the Netherlands.'}, {'ForeName': 'Maria B', 'Initials': 'MB', 'LastName': 'Leijs', 'Affiliation': 'Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Matthijs H', 'Initials': 'MH', 'LastName': 'Silbermann', 'Affiliation': 'Tergooi Hospitals, Hilversum, the Netherlands.'}, {'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Spaarne Gasthuis, Hoofddorp, the Netherlands.'}, {'ForeName': 'Marie J', 'Initials': 'MJ', 'LastName': 'Kersten', 'Affiliation': 'Amsterdam UMC, AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Lidwine W', 'Initials': 'LW', 'LastName': 'Tick', 'Affiliation': 'Maxima Medical Center, Eindhoven, the Netherlands.'}, {'ForeName': 'Rolf E', 'Initials': 'RE', 'LastName': 'Brouwer', 'Affiliation': 'Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'King H', 'Initials': 'KH', 'LastName': 'Lam', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Coreline N', 'Initials': 'CN', 'LastName': 'Burggraaff', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Keizer', 'Affiliation': 'UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Anne I', 'Initials': 'AI', 'LastName': 'Arens', 'Affiliation': 'Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'de Jong', 'Affiliation': 'HOVON Pathology Facility and Biobank, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Otto S', 'Initials': 'OS', 'LastName': 'Hoekstra', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra-Baalbergen', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03418']
1531,32731118,"Long-term safety and efficacy of brivaracetam in adults with focal seizures: Results from an open-label, multinational, follow-up trial.","BACKGROUND


This long-term follow-up (LTFU) trial was conducted to evaluate the long-term safety and tolerability of brivaracetam (BRV) at individualized doses (maximum of 200 mg/day) in patients with focal seizures. The secondary objective was to evaluate the efficacy of BRV over time.
METHODS


Two Phase III, randomized, double-blind, historical-controlled conversion-to-monotherapy trials (N01276: NCT00698581; N01306: NCT00699283) were conducted in patients aged ≥16 years with uncontrolled focal seizures. Patients who completed either of these core trials or who met a protocol-defined exit criterion could enter this LTFU trial (N01315; NCT00761774). Patients entered LTFU at a recommended BRV dose of 100 mg/day, with flexible dosing of 50-200 mg/day, as monotherapy or adjunctive therapy; additional AEDs could be prescribed and adapted in dose if clinically indicated. Safety variables included treatment-emergent adverse events (TEAEs). Efficacy variables included duration of continuous monotherapy, reduction in focal seizure frequency and seizure freedom. Safety and efficacy variables were assessed for all patients in the safety set or efficacy set, respectively, regardless of BRV treatment regimen. In addition, a post hoc subgroup analysis was conducted for patients who completed the BRV monotherapy period in either core trial, and entered the LTFU on BRV monotherapy. For this subgroup, TEAEs were summarized by 3-month time intervals over the first 12 months of LTFU.
RESULTS


108 patients were enrolled in the LTFU trial between November 2008 and February 2010. 79 (73.1 %) patients discontinued the LTFU trial, most commonly due to lack of efficacy [37 (34.3 %)] and adverse events [16 (14.8 %)]. At core trial baseline, patients had a median of 6.3 focal seizures/28 days and 53 (49.1 %) had failed ≥5 previous lifetime AEDs. During LTFU, 70 (64.8 %) patients had ≥12 months and 56 (51.9 %) patients had ≥24 months of BRV treatment. TEAEs were reported by 98 (90.7 %) patients; most commonly (≥15 % of patients) convulsion (17.6 %), nasopharyngitis (17.6 %), depression (16.7 %) and fatigue (15.7 %). Median percent reduction from baseline in focal seizure frequency/28 days was 56.8 %. Among 86 patients who completed at least 6 months of treatment, 29 (33.7 %) patients were seizure-free for ≥6 months and 22 (25.6 %) were seizure-free for ≥12 months. 50/108 patients were included in the BRV monotherapy subgroup; 33/50 (66.0 %) patients reported a TEAE in the core trials, while 26/50 (52.0 %), 15/37 (40.5 %), 14/33 (42.4 %) and 9/27 (33.3 %) patients reported any TEAE during LTFU months 1-3, 4-6, 7-9 and 10-12, respectively. In the BRV monotherapy subgroup, the most common TEAEs (≥5% of patients) during LTFU months 1-3 were fatigue [3/50 (6.0 %)] and dizziness [3/50 (6.0 %)].
INTERPRETATION


Results from the LTFU trial support the long-term safety of BRV at individualized doses of up to 200 mg/day as a well-tolerated, and effective treatment for patients with focal seizures. Efficacy analyses indicate that seizure reductions with brivaracetam were generally maintained over time.",2020,"TEAEs were reported by 98 (90.7 %) patients; most commonly (≥15 % of patients) convulsion (17.6 %), nasopharyngitis (17.6 %), depression (16.7 %) and fatigue (15.7 %).","['patients with focal seizures', '86 patients who completed at least 6 months of treatment, 29 (33.7 %) patients were seizure-free for ≥6 months and 22 (25.6 %) were seizure-free for ≥12 months', 'patients aged ≥16 years with uncontrolled focal seizures', 'adults with focal seizures', '108 patients were enrolled in the LTFU trial between November 2008 and February 2010']","['brivaracetam', 'brivaracetam (BRV', 'LTFU']","['dizziness', 'treatment-emergent adverse events (TEAEs', 'fatigue', 'Safety and efficacy variables', 'focal seizure frequency and seizure freedom', 'adverse events', 'nasopharyngitis', 'depression', 'seizure reductions with brivaracetam']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}]",108.0,0.524516,"TEAEs were reported by 98 (90.7 %) patients; most commonly (≥15 % of patients) convulsion (17.6 %), nasopharyngitis (17.6 %), depression (16.7 %) and fatigue (15.7 %).","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Arnold', 'Affiliation': 'Department of Neurology, Schön Klinik Vogtareuth, Krankenhausstraße 20, 83569, Vogtareuth, Germany. Electronic address: SArnold@Schoen-Kliniken.de.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Allée de la Recherche, 60, B - 1070 Brussels, Belgium. Electronic address: Cedric.Laloyaux@ucb.com.'}, {'ForeName': 'Anne-Liv', 'Initials': 'AL', 'LastName': 'Schulz', 'Affiliation': 'UCB Pharma, Alfred-Nobel-Strasse 10, 40789 Monheim am Rhein, Germany. Electronic address: Anne-Liv.Schulz@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Sami.Elmoufti@ucb.com.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Yates', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Stephen.Yates@ucb.com.'}, {'ForeName': 'Toufic', 'Initials': 'T', 'LastName': 'Fakhoury', 'Affiliation': 'St. Joseph Health System, 1401 Harrodsburg Road, Suite B-280, Lexington, KY 40504, USA. Electronic address: TouficFakhoury@catholichealth.net.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106404']
1532,32732574,CORR Insights®: Platelet-rich Plasma or Autologous Blood Do Not Reduce Pain or Improve Function in Patients with Lateral Epicondylitis: A Randomized Controlled Trial.,,2020,,['Patients with Lateral Epicondylitis'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}]",[],[],,0.233205,,"[{'ForeName': 'Nash H', 'Initials': 'NH', 'LastName': 'Naam', 'Affiliation': 'N. H. Naam, Professor of Clinical Hand Surgery, Southern Illinois University, Southern Illinois Hand Center, Effingham, IL, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001249']
1533,32735903,Ultra-Response to Ranibizumab: Improvement by 4 or More Steps in Diabetic Retinopathy Severity in Diabetic Retinopathy Clinical Research Network Protocol S.,"PURPOSE


To quantify and evaluate patients with diabetic retinopathy (DR) who had at least a 4-step improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) in response to treatment with ranibizumab in the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S study, and factors predictive of such improvements.
DESIGN


Post hoc retrospective analysis of 2-year outcomes in the phase 3 Protocol S study.
PARTICIPANTS


Patients randomized to treatment with ranibizumab 0.5 mg with sufficient baseline DRSS severity (≥47) to allow for an at least 4-step improvement (n = 181).
METHODS


Study eyes received a ranibizumab 0.5 mg injection at baseline and every 4 weeks for 12 weeks, with subsequent as-needed injections. Fundus photographs graded at baseline and years 1 and 2 using DRSS were used for this analysis. The data source is DRCR.net, but analyses, content, and conclusions of this report are solely the responsibility of the authors.
MAIN OUTCOME MEASURES


Proportion of eyes achieving at least a 4-step DRSS improvement (DR ultra-response) at years 1 and 2; treatment course for eyes achieving ultra-response; mean change in best-corrected visual acuity (BCVA) in eyes with and without ultra-response; factors associated with ultra-response (identified by univariate and multivariable analyses).
RESULTS


Approximately 30% of ranibizumab-treated eyes achieved DR ultra-response at year 1 (43/148; 29.1%) and year 2 (38/136; 27.9%); 74% of eyes with ultra-response at year 1 maintained their response at year 2. At year 2, patients with DR ultra-response had gained more than 5 additional ETDRS letters compared with those without DR ultra-response. Multivariable analyses identified presence of vitreous hemorrhage at baseline, increasing age, absence of epiretinal membrane, and glycated hemoglobin below 9 as predictive of DR ultra-response. Mean number of injections received was similar for eyes with versus without DR ultra-response to ranibizumab (mean, 7.4 vs. 7.6 in year 1; mean, 4.2 vs. 3.9 in year 2).
CONCLUSIONS


Approximately 30% of eyes with a DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least a 4-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.",2020,"Approximately 30% of eyes with an DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least 4-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.","['patients with diabetic retinopathy (DR) who had at least 4-step improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) in response to treatment with', 'Diabetic Retinopathy Severity in DRCR.net Protocol S']","['ranibizumab 0.5 mg with sufficient baseline DRSS severity', 'ranibizumab 0.5 mg injection', 'Ranibizumab', 'ranibizumab']","['Proportion of eyes achieving an at least 4-step DRSS improvement (DR ultra-response', 'visual acuity (BCVA', 'vitreous hemorrhage', 'Mean number of injections', 'BCVA', 'ultra-response', 'DR ultra-response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",181.0,0.139807,"Approximately 30% of eyes with an DRSS score of at least 47 receiving ranibizumab 0.5 mg per study protocol experienced at least 4-step DR severity improvement on the DRSS, accompanied by meaningful improvements in BCVA.","[{'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Chiang', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania. Electronic address: achiang@midatlanticretina.com.'}, {'ForeName': 'Sunir J', 'Initials': 'SJ', 'LastName': 'Garg', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Klufas', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Ho', 'Affiliation': 'Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Ivaylo', 'Initials': 'I', 'LastName': 'Stoilov', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Ophthalmology. Retina,['10.1016/j.oret.2020.07.009']
1534,32742507,Remote Ischemic Conditioning in Acute Ischemic Stroke - A Clinical Trial Design.,"Remote ischemic conditioning represents an intervention based on blood flow reduction applied at a distance from the lesion. The mechanism is supposed to elicit neurovascular protection, anti-inflammatory action, reduced excitotoxicity and metabolic protection. This study aims to explore the efficiency and safety of remote ischemic conditioning during the first five days following in patients who are ineligible for reperfusion treatment (intravenous thrombolysis or/and mechanical thrombectomy). We hypothesized that this intervention would reduce the infarct size (neuroprotection in the reperfusion window) and improve functional recovery. We aim to conduct a double-blind controlled trial, multicenter in two hospitals in Romania. Two hundred patients with acute ischemic stroke randomly divided into an experimental group and a control group will be included. The subjects in the experimental group will be subjected to remote ischemic conditioning twice daily with a maximum of 180 mmHg for 5 days, and a guideline- based treatment as well. The subjects in the control group will receive cuff inflation to 30 mmHg, which will induce sham preconditioning. The primary outcome measure will be radiological - the difference between baseline brain infarct volume and the volume at 180 days in the experimental group versus the control group. The second outcome considers clinical scores such as NIHSS, mRS, IADL, ADL, MOCA, PHQ-9 at baseline, 90 and 180 days; tolerance and side effects of remote ischemic conditioning; the reccurence of stroke or other vascular events at 180 days; incidence of stroke-associated comorbidities and the proportion of death of any cause within 180 days.",2020,This study aims to explore the efficiency and safety of remote ischemic conditioning during the first five days following in patients who are ineligible for reperfusion treatment (intravenous thrombolysis or/and mechanical thrombectomy).,"['patients who are ineligible for reperfusion treatment (intravenous thrombolysis or/and mechanical thrombectomy', 'multicenter in two hospitals in Romania', 'Two hundred patients with acute ischemic stroke']",['Remote Ischemic Conditioning'],"['efficiency and safety', 'radiological - the difference between baseline brain infarct volume and the volume', 'clinical scores such as NIHSS, mRS, IADL, ADL, MOCA, PHQ-9 at baseline, 90 and 180 days; tolerance and side effects of remote ischemic conditioning; the reccurence of stroke or other vascular events at 180 days; incidence of stroke-associated comorbidities and the proportion of death of any cause']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0751955', 'cui_str': 'Brain Infarct'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",200.0,0.147632,This study aims to explore the efficiency and safety of remote ischemic conditioning during the first five days following in patients who are ineligible for reperfusion treatment (intravenous thrombolysis or/and mechanical thrombectomy).,"[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Poalelungi', 'Affiliation': 'Neurology Department, Emergency Clinical Hospital Bucharest, Bucharest, Romania.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Turiac', 'Affiliation': 'Radiology Department, Emergency Clinical Hospital Bucharest, Bucharest, Romania.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Tulba', 'Affiliation': 'Neurology Department, Colentina Clinical Hospital, Bucharest, Romania.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Stoian', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Bogdan Ovidiu', 'Initials': 'BO', 'LastName': 'Popescu', 'Affiliation': 'Neurology Department, Colentina Clinical Hospital, Bucharest, Romania.'}]",Journal of medicine and life,['10.25122/jml-2020-0049']
1535,32742512,The Effect of Cognitive-Behavioral Counseling on Lifestyle in Pregnant Women: A Randomized Controlled Clinical Trial.,"The lifestyle of pregnant women has a close relationship with maternal and fetal health. In pregnant women, health-promoting behaviors lead to the promotion of quality of life and improvement of pregnancy outcomes. Therefore, the present study aimed to determine the effect of cognitive-behavioral counseling on pregnant women's lifestyle. This randomized controlled clinical trial study was performed in the health centers of Sanandaj, Iran. Seventy pregnant women were randomly assigned to intervention (n = 35) and control (n = 35) groups. The study was completed with 33 pregnant women in each group. In addition to routine pregnancy care, the control group received, the intervention group received 8 consecutive 60-90-minute counseling sessions with a cognitive-behavioral approach weekly. The Walker Health Promotion Lifestyle Questionnaire was completed before, immediately, and one month after the intervention by the participants of control and intervention groups. Data were collected from February until June 2017. Data were analyzed using SPSS version 16. The mean score of lifestyle in the intervention and control group was 139.78 ± 21.71 and 142.63 ± 19.12 before the intervention, which reached 151 ± 17.72 and 159.14 ± 14.77, respectively, after the intervention. The difference was significant in the intervention group (P = 0.001) but not in the control group (P = 0.619). Also, the mean scores of the two groups were not significantly different before intervention (P = 0.574), but this difference was statistically significant after the intervention (P = 0.029) and one month after the intervention (P = 0.001). Based on the results of this study, cognitive-behavioral counseling improves the lifestyle of pregnant women. Therefore, it is suggested that this type of counseling be used along with other services to improve the lifestyle of pregnant women in health care centers.",2020,"Also, the mean scores of the two groups were not significantly different before intervention (P = 0.574), but this difference was statistically significant after the intervention (P = 0.029) and one month after the intervention (P = 0.001).","['Seventy pregnant women', 'Pregnant Women', 'health centers of Sanandaj, Iran', '33 pregnant women in each group', 'pregnant women in health care centers', ""pregnant women's lifestyle"", 'pregnant women']","['intervention group received 8 consecutive 60-90-minute counseling sessions with a cognitive-behavioral approach weekly', 'Cognitive-Behavioral Counseling', 'cognitive-behavioral counseling']","['mean scores', 'mean score of lifestyle', 'Walker Health Promotion Lifestyle Questionnaire']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",70.0,0.0403728,"Also, the mean scores of the two groups were not significantly different before intervention (P = 0.574), but this difference was statistically significant after the intervention (P = 0.029) and one month after the intervention (P = 0.001).","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Farhodimoghadam', 'Affiliation': 'Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Heydarpour', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Salari', 'Affiliation': 'Department of Biostatistics, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Jaberghaderi', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of medicine and life,['10.25122/jml-2019-0163']
1536,32742515,"Comparison of the Effects of Haloperidol, Metoclopramide, Dexmedetomidine and Ginger on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy.","Nausea is a mental sensation of unease and discomfort before vomiting. Vomiting refers to the return of the contents of the upper gastrointestinal tract to the mouth caused by contractions of chest and abdomen muscles. Postoperative nausea and vomiting is an unpleasant experience with high treatment costs. Therefore, this study aimed to compare the effects of haloperidol, metoclopramide, dexmedetomidine, and ginger on postoperative nausea and vomiting after laparoscopy. This double-blind clinical trial was performed on all laparoscopy candidates at Valiasr hospital, Arak, Iran. The patients were randomly divided into four groups (haloperidol, metoclopramide, dexmedetomidine and ginger), and all patients underwent general anesthesia using fentanyl, midazolam, atracurium, and propofol. After intubation, tube fixation, and stable hemodynamic conditions, the patients received four ginger capsules with a hint of lemon. A group of patients received 25 μg of dexmedetomidine. In the Plasil group, 10 mg of metoclopramide was given 30 minutes before the completion of surgery. In addition, 0.5 cc of haloperidol (5 mg) was administered to a group of patients. Heart rate, blood pressure, and oxygen saturation were recorded from the beginning of surgery, every 15 minutes until the end of the surgery. Furthermore, the occurrence of nausea and vomiting was recorded during recovery, 2 and 4 hours after surgery. Data were then analyzed using the SPSS software v.23. Eighty-eight patients were enrolled in the study. The youngest and the oldest were 30 years and 70 years old, respectively, and the mean age was 48.02 ± 9.31 years. Moreover, the number of women in the four groups was higher than that of men. Blood pressure in the dexmedetomidine group was lower than the other four groups (P <0.05). The lowest heart rate was observed in the haloperidol group, while the highest heart rate was seen in the plasil group (P <0.05). The occurrence of vomiting and nausea was not significantly different between the four groups (P <0.05). Our results showed no significant difference in postoperative nausea and vomiting between the four drugs. Due to the hemodynamic changes induced by each drug, it is best to use these drugs based on the patient's condition. Ginger is also a herbal remedy that has fewer side effects, and this drug can be a good option for patients when there is no contraindication.",2020,Blood pressure in the dexmedetomidine group was lower than the other four groups (P <0.05).,"['After Laparoscopic Cholecystectomy', 'The youngest and the oldest were 30 years and 70 years old, respectively, and the mean age was 48.02 ± 9.31 years', 'Eighty-eight patients were enrolled in the study', 'all laparoscopy candidates at Valiasr hospital, Arak, Iran']","['general anesthesia using fentanyl, midazolam, atracurium, and propofol', 'Haloperidol, Metoclopramide, Dexmedetomidine and Ginger', 'metoclopramide', 'haloperidol', 'haloperidol, metoclopramide, dexmedetomidine, and ginger', 'dexmedetomidine', 'haloperidol, metoclopramide, dexmedetomidine and ginger']","['postoperative nausea and vomiting', 'Postoperative nausea and vomiting', 'Nausea', 'nausea and vomiting', 'Postoperative Nausea and Vomiting', 'highest heart rate', 'Blood pressure', 'occurrence of vomiting and nausea', 'lowest heart rate', 'Heart rate, blood pressure, and oxygen saturation']","[{'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0004234', 'cui_str': 'Atracurium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",88.0,0.0295143,Blood pressure in the dexmedetomidine group was lower than the other four groups (P <0.05).,"[{'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Naemi', 'Affiliation': 'Department of Surgery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Kashanitabar', 'Affiliation': 'Department of Surgery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shiva', 'Affiliation': 'Department of Surgery, Arak University of Medical Sciences, Arak, Iran.'}]",Journal of medicine and life,['10.25122/jml-2019-0070']
1537,32739460,The effect of moderate-intensity aerobic training on pulmonary function and estrogen receptor-alpha gene in postmenopausal women with vitamin D deficiency: A randomized control trial.,"BACKGROUND


The impact of aerobic training on pulmonary function by modulating gene expression of estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D) in postmenopausal women (PMW) with Vit D deficiency is uncertain.
OBJECTIVE


The purpose of this study was to examine the effect of 12 weeks of moderate-intensity aerobic training on pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D in PMW with Vit D deficiency.
METHODS


Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs) were randomized to exercise (EX, n = 15) and control (C, n = 14) groups. The EX group performed moderate-intensity aerobic training for 12 weeks (50-60 min/day, 3 days/week at 65-70% of maximal heart rate reserve), but the C group participated in no intervention and maintain their normal lifestyle during 12 weeks. The pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D were measured at baseline and week-12.
RESULTS


After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
CONCLUSIONS


The results suggested that 12 weeks of moderate-intensity aerobic training increased lymphocyte ERα gene expression as well as serum Vit D in sedentary PMW with Vit D deficiency although pulmonary function was not improved.",2020,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","['postmenopausal women with vitamin D deficiency', 'postmenopausal women (PMW) with Vit D deficiency', 'Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs']","['aerobic exercise intervention', 'aerobic training', 'C group participated in no intervention and maintain their normal lifestyle', 'exercise (EX', 'moderate-intensity aerobic training']","['pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D', 'estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D', 'pulmonary function parameters and sex hormones (17β-estradiol and progesterone', 'lymphocyte ERα gene expression', 'serum Vit D', 'pulmonary function and estrogen receptor-alpha gene', 'pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptors alpha'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",29.0,0.0296952,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran. Electronic address: ba.tartibian@gmail.com.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rahmati_bio@yahoo.com.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: r.afsargarebag@gmail.com.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: Z.sheikhlou@gmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103510']
1538,32739493,Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial.,"BACKGROUND


Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.
METHODS


A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.
DISCUSSION


This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.",2020,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","['Patients with advanced cancer and their caregivers are invited to enroll', 'patients with advanced cancer']","['person advance care planning (ACP) discussions versus web-based ACP', 'person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool']","['patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs', 'ACP effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.133077,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: jmr58@pitt.edu.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: rabob@pitt.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, USA; San Francisco Veterans Affairs Health Care System, SFVAMC 4150 Clement Street, #151R, San Francisco, CA 94121, USA. Electronic address: Rebecca.Sudore@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., 1304 Broad Street, Durham, NC 27705, USA. Electronic address: dfarrell@peopledesigns.com.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Belin', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: belin@pitt.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA. Electronic address: ada62@pitt.edu.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Department of Population Sciences, City of Hope Medical Center, 1500 Duarte Road, Duarte, CA 91010, USA. Electronic address: BFerrell@coh.org.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, A Division of C-TAC Innovations, PO Box 258, Oregon, WI 53575-0258, USA. Electronic address: bhammes@respectingchoices.org.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology and Cancer Therapeutics Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: chue2@upmc.edu.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 600 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15213, USA. Electronic address: douglas.white@pitt.edu.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Rak', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 3520 Fifth Ave, Suite100, Pittsburgh, PA 15213, USA. Electronic address: kjr8@pitt.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: yas28@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106071']
1539,32739494,Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.,"BACKGROUND


Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.
METHODS


At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.
RESULTS


Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.
CONCLUSIONS


Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).",2020,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"['healthy older individuals to 100\u202fmg', 'Eligible participants were healthy, free of major diseases and expected to survive 5\u202fyears', 'healthy older ASPREE participants', 'healthy older people enrolling', 'At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n\u202f=\u202f16,703; U.S., n\u202f=\u202f2411', 'uniquely healthy older population']","['ASPirin', 'aspirin or placebo']","['Cancer history and risk factors', 'Prevalence of prostate and breast cancer history', 'Cancer prevalence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",19114.0,0.463069,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"[{'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Suzanne.orchard@monash.edu.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Jessica.lockery@monash.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1G Royal Parade, Parkville, Victoria 3052, Australia. Electronic address: Peter.gibbs@petermac.org.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Galhina.polekhina@monash.edu.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Rory.wolfe@monash.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.zalcberg@monash.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Andrew.haydon@monash.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.mcneil@monash.edu.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St (Private Bag 23), Hobart 7000, Tasmania, Australia. Electronic address: Mark.nelson@utas.edu.au.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Kent Street, Bentley, Perth 6102, Western Australia, Australia. Electronic address: Christpher.reid@curtin.edu.au.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA. Electronic address: bkirpach@bermancenter.org.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA; Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, East River Parkway, Minneapolis 55455, Minnesota, USA. Electronic address: AMurray@bermancenter.org.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Robyn.woods@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106095']
1540,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
1541,32769647,Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.,"OBJECTIVE


To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.
METHODS


Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.
RESULTS


Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.
CONCLUSION


Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01959347.",2020,Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence.,"['Four hundred three women who participated in a randomized trial that compared', 'counseling women with mixed incontinence who are considering surgery', 'women with mixed urinary incontinence', 'Women With Mixed Urinary Incontinence']","['Midurethral Sling', 'Sling type (retropubic vs transobturator', 'perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling', 'midurethral sling', 'midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone']","['Worse UDI urgency scores', 'UDI (Urogenital Distress Inventory)-total score', 'Subjective failure', 'body mass index', 'Valsalva leak point pressure', 'mean incontinence episodes', 'Overall treatment failure', 'detrusor overactivity on cystometrogram (OR 2.25, aOR', 'overall failure', 'Objective failure']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}, {'cui': 'C0200000', 'cui_str': 'Cystometrogram'}, {'cui': 'C4068875', 'cui_str': '2.25'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",403.0,0.319142,Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence.,"[{'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California; the Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico; the Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; the Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.""}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ''}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': ''}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': ''}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Ridgeway', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Borello-France', 'Affiliation': ''}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': ''}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003989']
1542,32770353,Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.,"PURPOSE


The CD79b-targeted antibody-drug conjugate polatuzumab vedotin (pola), alone and with chemoimmunotherapy, has clinical efficacy and a tolerable safety profile in B-cell non-Hodgkin lymphoma (B-NHL). We assessed (a) whether exposure from global studies of pola is comparable to Asian patients, and (b) if the recommended pola dose is appropriate in Asian patients based on exposure.
METHODS


The pharmacokinetics (PK) of pola in Asian and global populations was characterized for three analytes (antibody-conjugated monomethyl auristatin E (MMAE) [acMMAE], total antibody, and unconjugated MMAE) in five phase 1b/2 single-agent and combination studies in B-NHL patients (JO29138 [JAPICCTI-142580], DCS4968g [NCT01290549], GO27834 [NCT01691898], GO29044 [NCT01992653], and GO29365 [NCT02257567]). PK data were compared between Japanese phase 1 JO29138 (JAPICCTI-142580) and global phase 1 DCS4968g (NCT01290549) studies and between Asian and non-Asian patients in the randomized relapsed/refractory B-NHL cohorts of the phase 1b/2 study GO29365 (NCT02257567). A population PK (popPK) model was used to assess the effects of Asian race and region on acMMAE and unconjugated MMAE exposure.
RESULTS


PK non-compartmental analysis (NCA) parameters for the key analyte acMMAE in the Japanese JO29138 (JAPICCTI-142580) and global phase 1 DCS4968g (NCT01290549) studies were similar. In GO29365 (NCT02257567), the phase 1b/2 combination study, mean exposure to the analytes was generally lower in Asian patients (by ~ 9.9 to 17.5%), but not to a clinically meaningful extent. Overall, the popPK model further suggested comparable PK in Asian patients with B-NHL (race or region) versus non-Asian patients.
CONCLUSION


Race has no clinically meaningful effect on pola PK. These results (and observations from efficacy/safety exposure-response analyses) support no pola dose adjustments are warranted for Asian patients with DLBCL.",2020,"Overall, the popPK model further suggested comparable PK in Asian patients with B-NHL (race or region) versus non-Asian patients.
","['Asian patients with DLBCL', 'patients with relapsed/refractory B-cell non-Hodgkin lymphoma', 'Asian patients with B-NHL (race or region) versus non-Asian patients']","['CD79b-targeted antibody-drug conjugate polatuzumab vedotin (pola), alone and with chemoimmunotherapy']","['total antibody, and unconjugated MMAE']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855090', 'cui_str': 'B-cell lymphoma refractory'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0104979', 'cui_str': 'Lymphocyte antigen CD79B'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C4078806', 'cui_str': 'polatuzumab vedotin'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0522530', 'cui_str': 'Unconjugated'}, {'cui': 'C1565020', 'cui_str': 'monomethyl auristatin E'}]",,0.0175106,"Overall, the popPK model further suggested comparable PK in Asian patients with B-NHL (race or region) versus non-Asian patients.
","[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA. rongshi@gmail.com.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ku', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ding', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm LLC, North Potomac, MD, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Jin Yan', 'Initials': 'JY', 'LastName': 'Jin', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Girish', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Chunze', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA. Lu.Dan@gene.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04119-8']
1543,32770831,"Cannabidivarin for HIV-Associated Neuropathic Pain: A Randomized, Blinded, Controlled Clinical Trial.","HIV remains a major burden to the health care system and neuropathic pain is the most common neurological complication of HIV infection. Because current treatment strategies often lack satisfying pain relief, cannabinoids (CBs) are discussed as a new option. We investigated cannabidivarin (CBDV) as treatment for HIV-associated neuropathic pain. We conducted a randomized, double-blind, placebo-controlled crossover study. Patients underwent two successive treatment phases (4 weeks each) and were treated with CBDV (400 mg/day) or placebo in a randomized order. A 3-week washout phase was designed to eliminate potential carry-over effects. Patients were followed up for 3 weeks after the end of the second treatment phase. The primary end point was pain intensity on an 11-point numeric rating scale, recorded in a diary. Secondary end points were additional pain medication, pain characteristics, and quality of life. We included 32 patients. The mean pain intensity under CBDV was 0.62 points higher compared with placebo (P = 0.16, 95% confidence interval -0.27 to 1.51). CBDV did not influence the amount of additional pain medication, pain characteristics, or quality of life. The incidence of adverse events was similar during both treatments. No suspected unexpected adverse reactions occurred during either treatment. CBDV was safe but failed to reduce neuropathic pain in patients with HIV. This may be explained by a lack of CB receptor activation, as indicated by preclinical experiments. Although a larger patient number might be desirable, we would not expect a change in the conclusions because the present differences are far from statistical significance. Therefore, we would currently not consider CBDV as a clinically meaningful treatment option for neuropathic pain.",2020,The mean pain intensity under cannabidivarin was 0.62 points higher compared to placebo (p=0.16; 95% CI -0.27 to 1.51).,"['HIV-associated neuropathic pain', '32 patients']","['cannabidivarin (400mg/d) or placebo', 'Cannabidivarin', 'placebo']","['mean pain intensity under cannabidivarin', 'pain intensity on an 11-point numeric rating scale', 'adverse events', 'adverse reactions', 'additional pain medication, pain characteristics or quality of life', 'neuropathic pain', 'additional pain medication, pain characteristics and quality of life']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3657549', 'cui_str': 'cannabidivarin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3657549', 'cui_str': 'cannabidivarin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1286315', 'cui_str': 'Characteristic of pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]",32.0,0.414352,The mean pain intensity under cannabidivarin was 0.62 points higher compared to placebo (p=0.16; 95% CI -0.27 to 1.51).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Eibach', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Scheffel', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Cardebring', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lettau', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Özgür Celik', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Morguet', 'Affiliation': 'Department of Cardiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Roehle', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Coordinating Center for Clinical Studies, Berlin Institute of Health, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stein', 'Affiliation': 'Department of Anesthesiology, Charité Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2016']
1544,32768874,Intermittent Motivational Interviewing and Transdiagnostic CBT for Anxiety: A Randomized Controlled Trial.,"Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI significantly increases the length of treatment and numerous studies note that the effectiveness of pre-treatment MI subsides over time. The current study adapted an already established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each, with the option of including additional MI if resistance arose in therapy. Thirty-six treatment seeking adults with principal anxiety disorder diagnosis were randomly assigned to receive intermittent MI and tCBT (iMI + tCBT) or tCBT and psychoeducation. Results indicated that the iMI + tCBT condition significantly outperformed the tCBT condition on several primary outcome variables. While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning. These effects were not moderated by baseline motivation or baseline ambivalence. The study also found that the iMI + tCBT condition showed significantly greater improvement to comorbid conditions and greater reduction in self-report depressive symptoms. The inclusion of MI did not impact participant drop out. This study provides further support for integrating MI and tCBT and highlights that even small doses of MI can improve treatment outcomes, without increasing length of usual therapy. Limitations and future research options are also discussed.",2020,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","['for Anxiety', 'Thirty-six treatment seeking adults with principal anxiety disorder diagnosis']","['Intermittent Motivational Interviewing and Transdiagnostic CBT', 'Cognitive Behavior Therapy (CBT', 'Motivational Interviewing (MI', 'intermittent MI and tCBT (iMI\u202f+\u202ftCBT) or tCBT and psychoeducation']","['self-report depressive symptoms', ""composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning""]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",36.0,0.0207886,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Marker', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Bronte E', 'Initials': 'BE', 'LastName': 'Corbett', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: Peter.Norton@monash.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102276']
1545,32768938,Yidu-toxicity blocking lung decoction ameliorates inflammation in severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome by eliminating IL-6 and TNF-a.,"The present study investigates the differences in inflammatory agents alterations, immune function, and leukocyte differential count evaluation in severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome after the recommended Chinese medicine prescription of Yidu-toxicity blocking lung decoction. A total of 40 patients with yidu-toxicity blocking lung syndrome, diagnosed as severe pneumonia of SARS-COV-2 following the latest Chinese national recommendations for the diagnosis and treatment of pneumonia caused by SARS-COV-2 (the 5th edition), were recruited. They were randomly divided into the pure western medicine therapy group (PWM) and integrated into Chinese and Western medicine therapy group (ICW). The general strategies were given to both groups according to the national recommendations, and the ICW group was given Yidu-toxicity blocking lung decoction extraorally. A radioimmunoassay method was adopted to detect the content of IL-6, IL-8,IL-2R,TNF-α, procalcitonin (PCT) and high-sensitivity C-reactive protein (hs-CRP) in sera. Flow cytometry was used to determine the peripheral blood lymphocyte subsets (the levels of CD3+, CD4+, CD8+, and the ratios of CD4+/CD8+). The white blood cell counts (WBC#), neutrophils count(N#), and lymphocyte counts (L#) were measured using a fully automatic blood rheological instrument. The t-test or Rank Sum Test and Spearman analysis were conducted to evaluate the differences. The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment. Infection related indicators such as WBC#, N#, L#, hs-CRP showed no differences. The analysis showed that there was no statistical difference in the values of CD4 and CD8 between the two groups. By the end of Day 29, all patients were discharged and the final cure rate for both group were 100 %. Taken together, we conclude that Yidu-toxicity blocking lung decoction could relieve inflammation of SARS-COV-2 patients with yidu-toxicity blocking lung syndrome by eliminating inflammatory agents. CM can serve as a complementary medication to western medicine, which should be highlighted in clinical settings.",2020,The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment.,"['severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome', '40 patients with yidu-toxicity blocking lung syndrome, diagnosed as severe pneumonia of SARS-COV-2 following the latest Chinese national recommendations for the diagnosis and treatment of pneumonia caused by SARS-COV-2 (the 5th edition), were recruited', 'severe pneumonia of SARS-COV-2 patients with Yidu-toxicity blocking lung syndrome after the recommended Chinese medicine prescription of Yidu-toxicity blocking lung decoction']","['ICW', 'pure western medicine therapy group (PWM) and integrated into Chinese and Western medicine therapy group (ICW', 'ICW group was given Yidu-toxicity blocking lung decoction extraorally', 'Yidu-toxicity blocking lung decoction']","['TNF-α', 'final cure rate', 'content of IL-6, IL-8,IL-2R,TNF-α, procalcitonin (PCT) and high-sensitivity C-reactive protein (hs-CRP', 'values of CD4 and CD8', 'white blood cell counts (WBC#), neutrophils count(N#), and lymphocyte counts (L', 'IL-6', 'peripheral blood lymphocyte subsets (the levels of CD3+, CD4+, CD8+, and the ratios of CD4+/CD8']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079720', 'cui_str': 'Lymphocyte Subpopulations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0200254,The results showed that IL-6 (P = 0.013) and TNF-α (P = 0.035) levels in the PWM group were significantly higher than those in the ICW group after treatment.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China. Electronic address: zhaojie0506888@126.com.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Chenghua', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Cao', 'Affiliation': 'Department of Orthopaedic, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Taohua', 'Initials': 'T', 'LastName': 'Wei', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei 230022, China.'}, {'ForeName': 'Qiaoxue', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Wanqun', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Chinese Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute for Medical Virology, Goethe University Frankfurt am Main, Frankfurt 60596, Germany.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110436']
1546,32768992,Cannabis use in patients 3 months after ceasing nabiximols for the treatment of cannabis dependence: Results from a placebo-controlled randomised trial.,"INTRODUCTION AND AIMS


Previous studies suggest cannabinoid agonist treatment is effective in reducing cannabis use in dependent treatment seekers, however few studies have reported on post-treatment outcomes. We examine cannabis use outcomes 12 weeks after cessation of treatment from a randomised placebo-controlled trial of nabiximols for the treatment of cannabis dependence.
METHOD


128 participants received either nabiximols (n = 61) or placebo (n = 67) for 12 weeks, in combination with psychosocial interventions. Self-reported number of days of cannabis use in the previous 28 days was measured at baseline, 4, 8, and 12 weeks (end of treatment) and again at 24 weeks (3 months after treatment ceased). Urinalysis was used to confirm self-report data at Week 24 interview.
RESULTS


A factorial mixed-effects model for repeated measures regression revealed that the nabiximols group used cannabis on 6.8 fewer days in the previous 28 days at week 12 (end of treatment) than the placebo group (p = 0.002, CI: 2.1,11.4), and 6.7 fewer days in the previous 28 days at the week-24 follow-up than the placebo group (p = 0.006, CI: 1.4,12.1). A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
DISCUSSIONS AND CONCLUSIONS


The benefits of treatment incorporating nabiximols with psychosocial interventions in reducing cannabis use appears to persist for up to 3 months after the cessation of treatment. A stepped care model of treatment is proposed.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12616000103460) https://www.anzctr.org.au.",2020,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","['patients 3 months after ceasing nabiximols for the treatment of cannabis dependence', '128 participants received either nabiximols (n = 61) or']","['nabiximols with psychosocial interventions', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],128.0,0.260502,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia. Electronic address: Nicholas.lintzeris@health.nsw.gov.au.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia; Priority Research Centre for Brain and Mental Health, School of Medicine and Public Health, University of Newcastle, NSW, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'University of New South Wales, NSW, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Mcgregor', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'University of Tasmania, TAS, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; University of New South Wales, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug Health, Western Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108220']
1547,32740179,Skin-to-Skin Care Is a Safe and Effective Comfort Measure for Infants Before and After Neonatal Cardiac Surgery.,"OBJECTIVES


To determine the effect of skin-to-skin care on stress, pain, behavioral organization, and physiologic stability of infants with critical congenital heart disease before and after neonatal cardiac surgery.
DESIGN


A baseline response-paired design was used, with infants acting as their own controls before, during, and after skin-to-skin care at two distinct time points: once in the preoperative period (T1) and once in the postoperative period (T2).
SETTING


Cardiac ICU and step-down unit in a large metropolitan freestanding children's hospital.
SUBJECTS


Convenience sample of 30 infants admitted preoperatively for critical congenital heart disease.
INTERVENTIONS


Eligible infants were placed into skin-to-skin care for 1 hour with their biological mothers once each at T1 and T2.
MEASUREMENTS AND MAIN RESULTS


Measurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs) were assessed immediately before skin-to-skin care, 30 minutes into skin-to-skin care, and 30 minutes after skin-to-skin care ended.At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline. At T1, infants also had significantly reduced heart rate (p = 0.002) and respiratory rate (p < 0.0001) and increased systolic blood pressure (p = 0.033) during skin-to-skin care. At both T1 and T2, infant cortisol remained stable and unchanged from pre-skin-to-skin care to during skin-to-skin care (p = 0.096 and p = 0.356, respectively), and significantly increased from during skin-to-skin care to post-skin-to-skin care (p = 0.001 and p = 0.023, respectively). Exploratory analysis revealed differences in cortisol reactivity for infants with higher baseline cortisol (> 0.3 μg/dL) versus lower (≤ 0.3 μg/dL) prior to skin-to-skin care. Infants with higher baseline cortisol at T2 experienced significantly reduced cortisol during skin-to-skin care (p = 0.025). No significant differences in demographics or baseline variables were found between infants in either group.
CONCLUSIONS


Skin-to-skin care is a low-cost, low-risk intervention that promotes comfort and supports physiologic stability in infants before and after neonatal cardiac surgery.",2020,"At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline.","['infants before and after neonatal cardiac surgery', 'infants with critical congenital heart disease before and after neonatal cardiac surgery', 'Infants Before and After Neonatal Cardiac Surgery', 'Convenience sample of 30 infants admitted preoperatively for critical congenital heart disease', ""large metropolitan freestanding children's hospital""]","['skin-to-skin care', 'Skin-to-Skin Care']","['stress, pain, behavioral organization, and physiologic stability', 'Measurements of stress (salivary cortisol), pain and behavior state (COMFORT scale), and physiologic stability (vital signs', 'heart rate', 'systolic blood pressure', 'respiratory rate', 'cortisol reactivity', 'infant pain scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0150773', 'cui_str': 'Skin care'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",30.0,0.0256545,"At both T1 and T2, infant pain scores were significantly decreased (p < 0.0001) and infants moved into a calmer behavior state (p < 0.0001) during skin-to-skin care as compared to baseline.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""Nursing and Clinical Care Services, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Abigail C', 'Initials': 'AC', 'LastName': 'Demianczyk', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Costarino', 'Affiliation': ""Cardiac Critical Care Medicine, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Vogiatzi', 'Affiliation': ""Adrenal and Puberty Center, Division of Endocrinology and Diabetes, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hoffman', 'Affiliation': 'Laboratory of Innovative & Translational Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Quinn', 'Affiliation': 'Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Chittams', 'Affiliation': 'Biostatistics Analysis Core, Office of Nursing Research, University of Pennsylvania School of Nursing, Philadelphia, PA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff-Cooper', 'Affiliation': ""Nursing and Clinical Care Services, Children's Hospital of Philadelphia, Philadelphia, PA.""}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002493']
1548,32740180,Investigating the Efficacy of Hydrocolloid Dressing for Preventing Nasotracheal Tube-Related Pressure Injury in the PICU.,"OBJECTIVES


To investigate the efficacy of hydrocolloid dressing in reducing the occurrence rate and severity of nasotracheal tube-related pressure injury.
DESIGN


Randomized controlled trial.
SETTING


A PICU in a tertiary medical center in southern China.
PATIENTS


Pediatric patients received invasive mechanical ventilation via nasotracheal tubes.
INTERVENTIONS


The hydrocolloid dressing was cut into an optimal square size, which should cover the area from the nasal columella to the ala.
MEASUREMENTS AND MAIN RESULTS


Eligible participants were randomly allocated to the control group and the experimental group. The participants in the experimental group received hydrocolloid dressing to protect nasal skin from the beginning of nasotracheal intubation, while the participants in the control group received the current care procedure (without hydrocolloid dressing) unless pressure injuries occurred. The hydrocolloid dressing was changed daily to assess the nasal skin. The pressure injury staging system that was redefined and updated by the National Pressure Ulcer Advisory Panel in 2016 was used. The mean duration of nasotracheal intubation was 150.10 ± 117.09 hours in the experimental group and 161.75 ± 120.72 hours in the control group. Forty-five participants had nasotracheal tube-related pressure injuries in control group, whereas 26 patients had in experimental group (72.6% vs 43.3%; absolute difference, 29.3%, 95% CI, 12.5-46%; p = 0.001). The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
CONCLUSIONS


Hydrocolloid dressing can not only reduce the occurrence rate of nasotracheal tube-related pressure injury in the child with long-term nasotracheal intubation but also improve the endurance of the nasal skin significantly.",2020,"The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
","['A PICU in a tertiary medical center in southern China', 'Pediatric patients received']","['invasive mechanical ventilation via nasotracheal tubes', 'hydrocolloid dressing', 'current care procedure (without hydrocolloid dressing', 'Hydrocolloid dressing', 'Hydrocolloid Dressing']","['occurrence rate', 'mean duration of nasotracheal intubation', 'nasal skin', 'nasotracheal tube-related pressure injuries', 'median survival times of the nasal skin integrity']","[{'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0122734', 'cui_str': 'Hydrocolloid dressing'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0396625', 'cui_str': 'Nasotracheal intubation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C1286235', 'cui_str': 'Integrity of skin'}]",,0.0311669,"The median survival times of the nasal skin integrity were 95.5 hours in the control group and 219.5 hours in the experimental group (p < 0.001).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jinlu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jine', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yanxuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Pediatric Intensive Care Unit, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""Department of Nursing, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.""}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002494']
1549,32740891,A Phase I Study to Evaluate Two Doses of Wharton's Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease.,"BACKGROUND


Because of their well-described immunosuppressive properties, allogeneic adult human mesenchymal stromal cells (MSC) derived from bone marrow have demonstrated safety and efficacy in steroid refractory acute graft versus host disease (SR aGVHD). Clinical trials have resulted in variable success and an optimal source of MSC has yet to be defined. Based on the importance of maternal-fetal interface immune tolerance, extraembryonic fetal tissues, such as the umbilical cord, may provide an superior tissue source of MSC to mediate immunomodulation in aGVHD.
METHODS


A two-dose cohort trial allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC, referred to as MSCTC-0010, here) were tested in 10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT). Following Good Manufacturing Practices isolation, expansion and cryostorage, WJMSC were thawed and administered via intravenous infusions on days 0 and 7 at one of two doses (low dose cohort, 2 × 10 6 /kg, n = 5; high dose cohort, 10 × 10 6 /kg, n = 5). To evaluate safety, patients were monitored for infusion related toxicity, Treatment Related Adverse Events (TRAE) til day 42, or ectopic tissue formation at day 90. Clinical responses were monitored at time points up to 180 days post infusion. Serum biomarkers ST2 and REG3α were acquired 1 day prior to first MSCTC-0010 infusion and on day 14.
RESULTS


Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed. Clinical response was suggested at day 28: the overall response rate (ORR) was 70%, 4 of 10 patients had a complete response (CR) and 3 had a partial response (PR). By study day 90, the addition of escalated immunosuppressive therapy was necessary in 2 of 9 surviving patients. Day 100 and 180 post infusion survival was 90% and 60%, respectively. Serum biomarker REG3α decreased, particularly in the high dose cohort, and with REG3α decrease correlated with clinical response.
CONCLUSIONS


Treatment of patients with de novo HR or SR aGVHD with low or high dose MSCTC-0010 was safe: the infusion was well-tolerated, and no TRAEs or ectopic tissue formation was observed. A clinical improvement was seen in about 70% patients, with 4 of 10 showing a complete response that may have been attributable to MSCTC-0010 infusions. These observations indicate safety of two different doses of MSCTC-0010, and suggest that the 10 × 10 6  cells/ kg dose be tested in an expanded randomized, controlled Phase 2 trial. Graphical abstract.",2020,"RESULTS


Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed.",['10 patients with de novo high risk (HR) or SR aGVHD post allogeneic hematopoietic stem cell transplantation (allo-HCT'],"[""Wharton's Jelly-Derived Mesenchymal Stromal Cells"", ""allogeneic Wharton's Jelly-derived mesenchymal stromal cells (WJMSC"", 'MSCTC-0010']","['Serum biomarkers', 'Adverse Events (TRAE) til day 42, or ectopic tissue formation', 'overall response rate (ORR', 'Serum biomarker REG3α', 'partial response (PR', 'tolerated, and no TRAEs or ectopic tissue formation', 'no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008519', 'cui_str': 'Ectopic tissue'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",10.0,0.118327,"RESULTS


Safety was indicated, e.g., no infusion-related toxicity, no development of TRAE, nor ectopic tissue formation in either low or high dose cohort was observed.","[{'ForeName': 'Rupal P', 'Initials': 'RP', 'LastName': 'Soder', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Buddhadeb', 'Initials': 'B', 'LastName': 'Dawn', 'Affiliation': 'University of Nevada, Las Vegas School of Medicine, Las Vegas, NV, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Weiss', 'Affiliation': 'Midwest Institute of Comparative Stem Cell Biotechnology and Department of Anatomy and Physiology, Kansas State University, Manhattan, KS, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Dunavin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Weir', 'Affiliation': 'Institute for Advancing Medical Innovation Medical Center, University of Kansas, Kansas City, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Meizhang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Pathology & Laboratory Medicine, Univeristy of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Shune', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Anurag K', 'Initials': 'AK', 'LastName': 'Singh', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Ganguly', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Abdelhakim', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Godwin', 'Affiliation': 'Pathology & Laboratory Medicine, Univeristy of Kansas Medical Center, Kansas City, USA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Abhyankar', 'Affiliation': 'Midwest Stem Cell Therapy Center, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McGuirk', 'Affiliation': 'Blood and Marrow Transplant Program, Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center, 2330 Shawnee Mission Parkway, Suite 210, Westwood, KS, 66205, USA. jmcguirk@kumc.edu.'}]",Stem cell reviews and reports,['10.1007/s12015-020-10015-8']
1550,32741133,The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury.,"BACKGROUND


Botulinum toxin (BoNT) injections were shown to improve muscle tone of limbs in patients with spasticity. However, limited data are available regarding the effects of repeated BoNT injections on walking ability.
OBJECTIVE


To assess changes in walking velocity (WV), step length, and cadence under different test conditions after repeated treatment with abobotulinumtoxinA (aboBoNT-A; Dysport) in spastic lower limb muscles.
DESIGN


Secondary analysis of an open-label, multiple-cycle extension (National Clinical Trials number NCT01251367) to a phase III, double-blind, randomized, placebo-controlled, single-treatment cycle study, in adults with chronic hemiparesis (NCT01249404).
SETTING


Fifty-two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States.
PATIENTS


352 Ambulatory adults (18-80 years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1 to 0.8 m/s.
INTERVENTIONS


Up to four aboBoNT-A treatment cycles, administered to spastic lower limb muscles.
MAIN OUTCOME MEASUREMENTS


Changes from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/minutes).
RESULTS


At Week 12 after four injections, WV improved by 0.08 to 0.10 m/s, step length by 0.03 to 0.04 m/step, and cadence by 3.9 to 6.2 steps/minutes depending on test condition (all P < .0001 to .0003 vs baseline). More patients (7% to 17%) became unlimited community ambulators (WV ≥0.8 m/s) across test conditions compared with baseline, with 39% of 151 patients classified as unlimited community ambulators in at least one test condition and 17% in all four test conditions.
CONCLUSIONS


Clinically meaningful and statistically significant improvements in WV, step length, and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.",2020,"CONCLUSIONS


Clinically meaningful and statistically significant improvements in WV, step length and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.","['patients with spasticity', 'adults with chronic hemiparesis (NCT01249404', 'patients with spastic hemiparesis', 'persons with spastic hemiparesis caused by stroke or traumatic brain injury', 'spastic lower limb muscles', 'Fifty-two centers across Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia, and the United States', '352 ambulatory adults (18-80\u2009years) with spastic hemiparesis and gait dysfunction caused by stroke or traumatic brain injury, with a comfortable barefoot WV of 0.1']","['Botulinum toxin (BoNT) injections', 'Repeated abobotulinumtoxinA (Dysport®) injection', 'abobotulinumtoxinA (aboBoNT-A; Dysport®', 'placebo']","['WV, step length and cadence', 'walking velocity', 'muscle tone of limbs', 'Changes from baseline in comfortable and maximal barefoot and with shoes WV (m/s), step length (m/step), and cadence (steps/min', 'walking velocity (WV), step length, and cadence under different test conditions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0154694', 'cui_str': 'Spastic hemiplegia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0206579', 'cui_str': 'Slovakia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4517420', 'cui_str': '0.1'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}, {'cui': 'C0591427', 'cui_str': 'Dysport'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449910', 'cui_str': 'Test conditions'}]",352.0,0.0929913,"CONCLUSIONS


Clinically meaningful and statistically significant improvements in WV, step length and cadence under all four test conditions were observed in patients with spastic hemiparesis after each aboBoNT-A treatment cycle.","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'MossRehab, Elkins Park, PA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Brashear', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Deltombe', 'Affiliation': 'Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire UCL, Yvoir, Belgium.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rudzinska-Bar', 'Affiliation': 'Department of Neurology, Faculty of Medicine and Health Service, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Krawczyk', 'Affiliation': 'Centrum Medyczne Plejady ul, Kraków, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Skoromets', 'Affiliation': 'Pavlov First St Petersburg State Medical University, St Petersburg, Russia.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': ""O'Dell"", 'Affiliation': 'Department of Rehabilitation Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Grandoulier', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Vilain', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Ipsen Innovation, Les Ulis, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Gracies', 'Affiliation': 'EA 7377 BIOTN, Université Paris-Est Créteil, Service de Rééducation Neurolocomotrice, Hôpitaux Universitaires Henri Mondor, Créteil, France.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12459']
1551,32741328,A Secondary Injury Prevention Program May Decrease Contralateral Anterior Cruciate Ligament Injuries in Female Athletes: 2-Year Injury Rates in the ACL-SPORTS Randomized Controlled Trial.,"OBJECTIVE


To determine whether the addition of perturbation training to a secondary injury prevention program reduces the rate of second anterior cruciate ligament (ACL) injury compared to the prevention program alone.
DESIGN


Single-blinded randomized controlled trial.
METHODS


Thirty-nine female athletes who intended to return to cutting/pivoting sports were enrolled 3 to 9 months after primary anterior cruciate ligament reconstruction (ACLR). Athletes were randomized to receive a training program of either progressive strengthening, agility, plyometrics, and prevention (SAPP) (n = 20) or SAPP plus perturbation training (n = 19); each had 10 sessions over 5 weeks. Occurrence and side of second ACL injury were recorded for 2 years after primary ACLR.
RESULTS


There were 9 second ACL injuries in the 2 years after ACLR. There was no statistically significant difference in rate or side of second ACL injury between the SAPP-plus-perturbation training and SAPP groups.
CONCLUSION


Adding perturbation training to a secondary ACL injury prevention program did not affect the rate of second ACL injury in female athletes.  J Orthop Sports Phys Ther 2020;50(9):523-530. Epub 1 Aug 2020. doi:10.2519/jospt.2020.9407 .",2020,"There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
","['Thirty-nine female athletes who intended to return to cutting/pivoting sports were enrolled 3-9 months after primary ACLR', 'female athletes', 'Female Athletes']","['perturbation training to a secondary injury prevention program', 'progressive strengthening, agility, plyometric, and prevention (SAPP) or SAPP plus perturbation training (SAPP+PERT']","['Occurrence and side of second ACL injury', 'Contralateral Anterior Cruciate Ligament Injuries', 'rate or side of second ACL injury', 'rate of second ACL injuries', 'rate of second anterior cruciate ligament (ACL) injuries']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",39.0,0.0258922,"There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Capin', 'Affiliation': ''}, {'ForeName': 'Amelia J H', 'Initials': 'AJH', 'LastName': 'Arundale', 'Affiliation': ''}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarzycki', 'Affiliation': ''}, {'ForeName': 'Angela H', 'Initials': 'AH', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snyder-Mackler', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9407']
1552,32741642,"The effect of a single 75 mg preoperative dose of pregabalin on postoperative pain in rhinoplasty: A double-blinded, placebo-controlled randomized clinical trial.","The goal of this study was to evaluate the effect of a single preoperative dose of 75 mg of pregabalin on postoperative pain in rhinoplasty. Volunteers with a physical status of ASA I were included in our study after informed written consent. This was a randomized, double-blinded, placebo-controlled clinical trial. All pregabalin and placebo capsules were given to patients orally 1 h prior to surgery. A standard open rhinoplasty procedure was performed on all patients. All patients underwent the same general anesthesia and postoperative analgesic protocol, with the only difference between the two studied groups being the use of a single dose of pregabalin prior to surgery. Finally, pain intensity was measured at 2, 4, 6, 12, and 24 h after surgery, using a horizontal visual analogue scale (VAS), and was analyzed statistically. 128 volunteers - 33 men (25.8%) and 95 women (74.2%) - with a mean age of 26.23 ± 7.16 were included in this study. Pain intensity scores were consistently lower in patients who received pregabalin preoperatively (p = 0.002); however, the incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation showed no differences between the two study groups (p > 0.05). In conclusion, the administration of pregabalin should be added to the perioperative protocol whenever appropriate.",2020,"p = 0.002); however, the incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation showed no differences between the two study groups (p > 0.05).","['rhinoplasty', '128 volunteers - 33 men (25.8%) and 95 women (74.2%) - with a mean age of 26.23\xa0±\xa07.16 were included in this study', 'Volunteers with a physical status of ASA I']","['pregabalin', 'pregabalin and placebo', 'placebo']","['pain intensity', 'postoperative pain', 'horizontal visual analogue scale (VAS', 'incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation', 'Pain intensity scores']","[{'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",128.0,0.422842,"p = 0.002); however, the incidence of nausea, drowsiness, difficulty in concentrating, dry mouth, and constipation showed no differences between the two study groups (p > 0.05).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mohammadi', 'Affiliation': 'School of Dentistry, Kermanshah University of Medical Sciences (KUMS), Iran.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Yazdani', 'Affiliation': 'Clinical Trials Center, KUMS, Iran.'}, {'ForeName': 'Hesamedin', 'Initials': 'H', 'LastName': 'Nazari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, KUMS, Iran. Electronic address: H.nazari@kums.ac.ir.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Choubsaz', 'Affiliation': 'Anesthesiology and Intensive Care, School of Medicine, KUMS, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Azizi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, KUMS, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Nazari', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dentistry, KUMS, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Safari-Faramani', 'Affiliation': 'Epidemiology, Research Center for Environmental Determinants of Health, KUMS, Iran.'}, {'ForeName': 'Seyed Mojtaba', 'Initials': 'SM', 'LastName': 'Amiri', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, KUMS, Iran.'}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.03.006']
1553,32745667,Relationships between rectal and perirectal doses and rectal bleeding or tenesmus in pooled voxel-based analysis of 3 randomised phase III trials.,"BACKGROUND AND PURPOSE


This study aimed to identify anatomically-localised regions where planned radiotherapy dose is associated with gastrointestinal toxicities in healthy tissues throughout the pelvic anatomy.
MATERIALS AND METHODS


Planned dose distributions for up to 657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset. Voxel-based multiple comparison permutation dose difference testing, Cox regression modelling and LASSO feature selection were used to identify regions where dose-increase was associated with grade ≥2 rectal bleeding (RB) or tenesmus, according to the LENT/SOMA scale. This was externally validated by registering dose distributions from the RT01 (n = 388) and CHHiP (n = 241) trials onto the same exemplar and repeating the tests on each of these data sets, and on all three datasets combined.
RESULTS


Voxel-based Cox regression and permutation dose difference testing revealed regions where increased dose was correlated with gastrointestinal toxicity. Grade ≥2 RB was associated with posteriorly extended lateral beams that manifested high doses (>55 Gy) in a small rectal volume adjacent to the clinical target volume. A correlation was found between grade ≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
CONCLUSIONS


The serial response of the rectum with respect to RB has been demonstrated in patients with posteriorly extended lateral beams. Similarly, the parallel response of the PRFS with respect to tenesmus has been demonstrated in patients treated with the posterior beam.",2020,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
","['patients with posteriorly extended lateral beams', '657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset']",[],"['grade≥2 rectal bleeding (RB) or tenesmus', 'gastrointestinal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0232726', 'cui_str': 'Rectal tenesmus'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}]",,0.0350618,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; CSIRO, Herston, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Crawley, Australia; 5D Clinics, Claremont, Australia; GenesisCare WA, Wembley, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, Australia.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia; 5D Clinics, Claremont, Australia.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.048']
1554,32754804,Efficacy of GAD-alum immunotherapy associated with HLA-DR3-DQ2 in recently diagnosed type 1 diabetes.,"AIMS/HYPOTHESIS


The aim of this study was to determine if retention of C-peptide following immunotherapy using recombinant GAD65 conjugated to aluminium hydroxide (GAD-alum) is influenced by HLA risk haplotypes DR3-DQ2 and DR4-DQ8.
METHODS


HLA-dependent treatment effect of GAD-alum therapy on C-peptide retention in individuals with recent-onset type 1 diabetes was evaluated using individual-level patient data from three placebo-controlled, randomised clinical trials using a mixed repeated measures model.
RESULTS


A significant and dose-dependent effect was observed in individuals positive for the genotypes that include HLA-DR3-DQ2 but not HLA-DR4-DQ8 and in the broader subgroup of individuals positive for all genotypes that include HLA-DR3-DQ2 (i.e. including those also positive for HLA-DR4-DQ8). Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
CONCLUSIONS/INTERPRETATION


GAD65-specific immunotherapy has a significant effect on C-peptide retention in individuals with recent-onset type 1 diabetes who have the DR3-DQ2 haplotype. Graphical abstract.",2020,"Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
","['individuals with recent-onset type 1 diabetes who have the DR3-DQ2 haplotype', 'individuals with recent-onset type 1 diabetes']","['placebo', 'recombinant GAD65 conjugated to aluminium hydroxide (GAD-alum', 'GAD-alum therapy', 'GAD-alum immunotherapy']",['HLA-DR3-DQ2'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0019772', 'cui_str': 'HLA-DR3 antigen'}]",,0.276531,"Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Hannelius', 'Affiliation': 'Diamyd Medical AB, Kungsgatan 29, 111 56, Stockholm, Sweden. ulf.hannelius@diamyd.com.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Beam', 'Affiliation': 'Department of Biomedical Sciences, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': ""Crown Princess Victoria Children's Hospital, Linköping, Sweden. Johnny.Ludvigsson@liu.se.""}]",Diabetologia,['10.1007/s00125-020-05227-z']
1555,32750572,Clinical outcomes from the texting for relapse prevention (T4RP) in schizophrenia and schizoaffective disorder study.,"This 6 month randomized control trial investigated whether a novel text-messaging program impacted targeted clinical outcomes in patients with schizophrenia and schizoaffective disorder (SAD). Forty patients were enrolled and completed baseline, 3-month and 6-month assessments. The intervention group received daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text. The control group had treatment as usual. At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group. Recovery scores were significantly higher at 3 months. Results suggest that this program may benefit individuals with schizophrenia/SAD who use text messaging. Further investigation in a larger sample appears warranted.",2020,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"['patients with schizophrenia and schizoaffective disorder (SAD', 'Forty patients were enrolled and completed baseline, 3-month and 6-month assessments']","['texting for relapse prevention (T4RP', 'daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text', 'novel text-messaging program']","['Recovery scores', 'injectable medication compliance', 'Positive and Negative Syndrome Scale mean positive score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",40.0,0.0323144,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"[{'ForeName': 'Bernadette A', 'Initials': 'BA', 'LastName': 'Cullen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. Electronic address: bcullen@jhmi.edu.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Eaton', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Von Mach', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, USA.""}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Center for Innovative Public Health Research, San Clemente, California, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113346']
1556,32750626,Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial.,"Patient-centered care has received significant attention and is an integral component of high-quality healthcare. While it is often assumed that most prefer a patient-centered role orientation, such preferences exist along a continuum with some patients preferring a more provider-centered role. The present study examines patient preference data from a randomized clinical trial designed to test the efficacy of a patient activation intervention to promote thiazide prescribing for veteran patients with uncontrolled hypertension. Patient preferences for involvement in healthcare were assessed using the 9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS). The primary aim was to examine differences in discussion of thiazide use in the clinical encounter by those scoring high versus low on the PPOS. Five hundred ninety-five veteran patients were randomized to either one of three intervention groups or a usual care control group. The adjusted odds ratios (OR) for the three intervention groups relative to the control group indicated that thiazide discussion increased as a function of intervention intensity across both high and low PPOS groups. ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients. Results suggest that this patient activation intervention is effective for veteran patients representing a range of preferred involvement. Consideration of such preferences may be useful in tailoring future interventions in the healthcare context.",2020,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","['Five hundred ninety-five veteran patients', 'veteran patients with uncontrolled hypertension', 'hypertension']","['patient activation intervention', 'thiazide prescribing', 'thiazide', 'activation intervention', 'usual care control group']","['9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS', 'adjusted odds ratios (OR', 'function of intervention intensity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",595.0,0.0335965,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Department of Behavioral Sciences & Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA. Electronic address: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA; Department of Psychological & Brain Sciences, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113244']
1557,31611625,The relative importance of factors predicting outcome for myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial.,"Disease factors such as tumor burden and molecular risk affect myeloma patient outcomes as well as patient factors that impact the capacity to deliver treatment. How the relative importance of these factors changes with patient age has not previously been investigated comprehensively. We analyzed data from 3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI. Even with novel therapeutic approaches progression-free survival (PFS) and overall survival (OS) are affected by age with a stepwise reduction in PFS and OS with each decade increase. Renal function deteriorated with increasing age whilst the frequency of t(4;14) and del(17p) decreased and gain(1q) increased. The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group. Molecular events have a larger effect on outcome in younger patients with their relative contribution diminishing in the elderly. Performance status is important for patient outcome at all ages suggesting that physical frailty may be a more important predictor of outcome than age itself. Significant differences in the factors driving patient outcomes at different ages are important to consider as we design disease segmentation strategies to deliver personalized treatment approaches.",2020,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","['myeloma patients at different ages: results from 3894 patients in the Myeloma XI trial', 'younger patients with their relative contribution diminishing in the elderly', '3894 patients of all ages uniformly treated in a large clinical trial of myeloma patients, Myeloma XI']",[],"['relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival', 'progression-free survival (PFS) and overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0547204,"The relative contribution of performance status, international staging score and molecular risk to progression-free and overall survival varied by age group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Pawlyn', 'Affiliation': 'The Institute of Cancer Research, London, UK. charlotte.pawlyn@icr.ac.uk.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cairns', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Striha', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Vallari', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Jenner', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Drayson', 'Affiliation': 'Clinical Immunology Service, Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Owen', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': 'Section of Experimental Haematology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Morgan', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Jackson', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Davies', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, UK.'}]",Leukemia,['10.1038/s41375-019-0595-5']
1558,32757049,Effect of high-fat diet on the pharmacokinetics and safety of flumatinib in healthy Chinese subjects.,"PURPOSE


To evaluate the effect of a high-fat diet on the pharmacokinetics and safety of flumatinib mesylate tablets in healthy Chinese subjects.
METHODS


This study was a randomized, open-label, single-dose, two-period crossover trial in which subjects were randomly assigned to take 400 mg of flumatinib mesylate after a high-fat diet or a fasted state. After a 14-day washout period, the two groups were administered flumatinib mesylate under opposite conditions. Blood samples were collected at baseline 0 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, and 96 h, respectively. Plasma concentrations of flumatinib and its metabolites (M1 and M3) were analyzed using liquid chromatography-mass spectrometry. Pharmacokinetic parameters were calculated using the non-compartmental module of the Phoenix WinNonlin Version 7.0 software. BE module of WinNonLin was used for statistical analysis of AUC 0-t , AUC 0-∞  and C max  in plasma.
RESULTS


Twelve healthy subjects, half male and half female, were enrolled. One subject withdrew due to a treatment-emergent adverse event. Eleven subjects were administered drugs on fasting and 12 were administered drugs after a high-fat diet. On high-fat diet/fasting, the least square geometric mean (LSGM) ratios of flumatinib, M1, M3, and their 90% confidence interval (CI) were as follows: for flumatinib, C max , AUC 0-t  and AUC 0-∞  were 281.65% (225.80-351.31%), 167.43% (143.92-194.79%), and 166.87% (143.47-194.09%); for M1, C max , AUC 0-t , and AUC 0-∞  were 188.59% (145.29-244.79), 163.94% (149.11-180.24%), and 164.48% (150.36-179.94%); for M3, C max , AUC 0-t , and AUC 0-∞  were 63.47% (54.02-74.57%), 85.23% (74.72-97.22%), and 96.73% (86.63-108.02%).
CONCLUSION


Among the subjects, oral administration of 400 mg of flumatinib was safe and well tolerated. High-fat diet significantly increases the exposure to flumatinib, therefore, fasting may be recommended.
CLINICAL TRIAL REGISTRATION


The study was registered at chictr.org Identifier: ChiCTR-IIR-17013179.",2020,"AUC 0-∞  were 63.47% (54.02-74.57%), 85.23% (74.72-97.22%), and 96.73% (86.63-108.02%).
","['Eleven subjects were administered drugs on fasting and 12 were administered drugs after a high-fat diet', 'healthy Chinese subjects', 'Twelve healthy subjects, half male and half female, were enrolled']","['WinNonLin', 'high-fat diet', 'oral administration of 400\xa0mg of flumatinib', 'flumatinib mesylate tablets', 'flumatinib mesylate']","['least square geometric mean (LSGM) ratios of flumatinib, M1, M3, and their 90% confidence interval (CI', 'Plasma concentrations of flumatinib and its metabolites (M1 and M3', 'pharmacokinetics and safety of flumatinib', 'Blood samples', 'AUC 0-t  and AUC 0-∞', 'safe and well tolerated', 'Pharmacokinetic parameters']","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0025619', 'cui_str': 'Mesilates'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",12.0,0.0595274,"AUC 0-∞  were 63.47% (54.02-74.57%), 85.23% (74.72-97.22%), and 96.73% (86.63-108.02%).
","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Hui-Ling', 'Initials': 'HL', 'LastName': 'Song', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Wu', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qing-Nan', 'Initials': 'QN', 'LastName': 'He', 'Affiliation': 'Research Center for Drug Clinical Evaluation of Central, Central South University, Changsha, Hunan, China. heqn2629@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China. cellahuang1988@163.com.'}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-020-04117-w']
1559,32757060,"Examining potential effects of arousal, valence, and likability of music on visually induced motion sickness.","The present study investigated how valence, arousal, and subjective liking of music affect visually induced motion sickness (VIMS). VIMS is a common side effect when interacting with virtual environments, resulting in discomfort, dizziness, and/or nausea. Music has previously been shown to reduce VIMS, but the precise nature of this effect remains unknown. Eighty participants watched a video of a bicycle ride filmed from a first-person perspective. First, participants (n = 40) were randomly assigned to one of four groups that listened to pre-selected, classical music excerpts varying in valence and arousal (happy, peaceful, agitated, sad) while watching the video. Second, the level of subjective liking of music was maximized by asking participants to select their favourite music (n = 20), which was then played during the video. A control group (n = 20) watched the video without music. VIMS was measured using the Fast Motion Sickness Scale (FMS) and the Simulator Sickness Questionnaire (SSQ). No effects of valence or arousal on VIMS symptoms were found. Instead, we found that VIMS was significantly reduced when music liking was maximized: Participants who listened to their favourite music reported less VIMS compared to those who did not listen to music at all or to pre-selected music that they liked less. Music that is highly liked can, under certain circumstances, successfully reduce VIMS. These effects appear to be independent of the valence and arousal characteristics of the music.",2020,VIMS was measured using the Fast Motion Sickness Scale (FMS) and the Simulator Sickness Questionnaire (SSQ).,"['Eighty participants watched a video of a bicycle ride filmed from a first-person perspective', 'participants (n\u2009=\u200940']","['VIMS', 'listened to pre-selected, classical music excerpts varying in valence and arousal (happy, peaceful, agitated, sad) while watching the video', 'video without music']","['level of subjective liking of music', 'music liking', 'valence or arousal on VIMS symptoms', 'valence, arousal, and subjective liking of music affect visually induced motion sickness (VIMS', 'VIMS', 'Fast Motion Sickness Scale (FMS) and the Simulator Sickness Questionnaire (SSQ', 'discomfort, dizziness, and/or nausea']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0577368', 'cui_str': 'Does ride a bicycle'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",80.0,0.245755,VIMS was measured using the Fast Motion Sickness Scale (FMS) and the Simulator Sickness Questionnaire (SSQ).,"[{'ForeName': 'Katlyn', 'Initials': 'K', 'LastName': 'Peck', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Russo', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Campos', 'Affiliation': 'KITE-Toronto Rehabilitation Institute, University Health Network, 550 University Avenue, Toronto, ON, M5G 2A2, Canada.'}, {'ForeName': 'Behrang', 'Initials': 'B', 'LastName': 'Keshavarz', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto, ON, Canada. behrang.keshavarz@uhn.ca.'}]",Experimental brain research,['10.1007/s00221-020-05871-2']
1560,32772073,The influence of oxygen concentration during embryo culture on obstetric and neonatal outcomes: a secondary analysis of a randomized controlled trial.,"STUDY QUESTION


Does oxygen concentration during 3-day embryo culture affect obstetric and neonatal outcomes?
SUMMARY ANSWER


Oxygen concentration during 3-day embryo culture does not seem to affect the obstetric and neonatal outcomes measured.
WHAT IS KNOWN ALREADY


Atmospheric oxygen appears to be harmful during extended embryo culture. Embryo culture conditions might therefore be a potential risk factor for subsequent fetal development and the health of future children. No data are available concerning the obstetrics and neonatal outcomes after Day 3 transfer of embryos cultured under reduced and atmospheric oxygen tensions.
STUDY DESIGN, SIZE, DURATION


A secondary analysis of a previous randomized controlled trial assessing clinical pregnancy outcomes was carried out. This analysis included 1125 consecutive oocyte donation cycles utilizing ICSI or IVF and Day 3 embryo transfers between November 2009 and April 2012. The whole cohort of donated oocytes from patients who agreed to participate in the study were randomly allocated (1:1 ratio) to a reduced O2 tension group (6% O2) or an air-exposed group (20% O2) based on a computer-generated randomization list. Fresh and vitrified oocytes were used for oocyte donation. Only those pregnancies with a live birth at or beyond 24 weeks of gestation were included.
PARTICIPANTS/MATERIALS, SETTING, METHODS


Day 3 embryos were cultured in an atmosphere of 5.5% CO2, 6% O2, 88.5% N2 versus a dual gas system in air.
MAIN RESULTS AND THE ROLE OF CHANCE


From the eligible 1125 cycles, 564 were allocated to the 6% O2 group and 561 cycles to the 20% O2 group. However, 50 and 62 cycles did not reach embryo transfer in the 6% and 20% O2 groups, respectively. No differences were found between 6% O2 and atmospheric O2 tension in the number of livebirths per embryo transfer (mean ± SD, 0.5 ± 0.7 versus 0.5 ± 0.7), pregnancy complications or neonatal outcomes. Both groups (6% and atmospheric O2) had similar single and twin delivery rates (40.8% versus 38.1% and 10.7% versus 12.3%, respectively). Preterm delivery rates and very preterm delivery rates (10.80% versus 13.24% and 1.25% versus 2.94%, respectively), birthweight (3229 ± 561 g versus 3154 ± 731 g), low birthweight (2.92% versus 2.45%), birth height (50.18 ± 2.41 cm versus 49.7 ± 3.59 cm), head circumference (34.16 ± 1.87 cm versus 33.09 ± 1.85 cm) and 1 min Apgar scores (8.96 ± 0.87 versus 8.89 ± 0.96) were also similar between 6% and atmospheric O2 groups, respectively.
LIMITATIONS, REASONS FOR CAUTION


The number of liveborns finally analyzed is still small and not all obstetric and neonatal variables could be evaluated. Furthermore, a small proportion of the obstetric and neonatal data was obtained through a questionnaire filled out by the patients themselves. One reason for the lack of effect of oxygen concentration on pregnancy outcome could be the absence of trophectoderm cells at cleavage stage, which may make Day 3 embryos less susceptible to hypoxic conditions.
WIDER IMPLICATIONS OF THE FINDINGS


Nowadays many IVF laboratories use a more physiological oxygen concentration for embryo culture. However, the benefits of using low oxygen concentration on both laboratory and clinical outcomes during embryo culture are still under debate. Furthermore, long-term studies investigating the effect of using atmospheric O2 are also needed. Gathering these type of clinical data is indeed, quite relevant from the safety perspective. The present data show that, at least in egg donation cycles undergoing Day 3 embryo transfers, culturing embryos under atmospheric oxygen concentration seems not to affect perinatal outcomes.
STUDY FUNDING/COMPETING INTEREST(S)


The present project was supported by the R + D program of the Regional Valencian Government, Spain (IMPIVA IMDTF/2011/214). The authors declare that they have no conflict of interest with respect to the content of this manuscript.
TRIAL REGISTRATION NUMBER


NCT01532193.",2020,"No differences were found between 6% O2 and atmospheric O2 tension in the number of livebirths per embryo transfer (mean ± SD, 0.5 ± 0.7 versus 0.5 ± 0.7), pregnancy complications or neonatal outcomes.",['1125 consecutive oocyte donation cycles utilizing ICSI or IVF and Day 3 embryo transfers between November 2009 and April 2012'],['reduced O2 tension group (6% O2) or an air-exposed group (20% O2) based on a computer-generated randomization list'],"['oxygen concentration', 'birth height', 'pregnancy complications or neonatal outcomes', 'reach embryo transfer', 'low birthweight', 'O2 and atmospheric O2 tension', 'head circumference', 'min Apgar scores', 'similar single and twin delivery rates', 'Preterm delivery rates and very preterm delivery rates']","[{'cui': 'C0242813', 'cui_str': 'Oocyte donation'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0032962', 'cui_str': 'Complication of pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0233365', 'cui_str': 'Twin birth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",1125.0,0.140438,"No differences were found between 6% O2 and atmospheric O2 tension in the number of livebirths per embryo transfer (mean ± SD, 0.5 ± 0.7 versus 0.5 ± 0.7), pregnancy complications or neonatal outcomes.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rendón Abad', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Serra', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Gámiz', 'Affiliation': 'In Vitro Fertilization Laboratory, IVIRMA Valencia, Valencia, Spain.'}, {'ForeName': 'José Maria', 'Initials': 'JM', 'LastName': 'de Los Santos', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Josè', 'Initials': 'J', 'LastName': 'Remohí', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}, {'ForeName': 'Alfredo T', 'Initials': 'AT', 'LastName': 'Navarro', 'Affiliation': 'IVI Foundation, Instituto de Investigación Sanitaria la Fe, Valencia, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'de Los Santos', 'Affiliation': 'OBGYN Department, School of Medicine, Valencia University, Valencia, Spain.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa152']
1561,32779728,Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.,"INTRODUCTION


Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS


The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION


The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.",2020,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","['patients with COVID-19 and severe hypoxia', '1000 adult patients with COVID-19 receiving ≥10\xa0L/min of oxygen or on']","['Low-dose hydrocortisone', 'mechanical ventilation to intravenous hydrocortisone 200\xa0mg daily vs placebo (0.9% saline', 'Corticosteroids']","['longer time to viral clearance', 'Kryger Jensen and Lange test in the intention to treat population', 'health-related quality of life', 'days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy', 'time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality', 'serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",1000.0,0.37202,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","[{'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjær', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Carl Johan Steensen', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Steen', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter Buhl', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mik', 'Initials': 'M', 'LastName': 'Wetterslev', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mohr', 'Affiliation': 'Department of Intensive Care, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjællands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Mette Friberg', 'Initials': 'MF', 'LastName': 'Hitz', 'Affiliation': 'Internal Medicine Department, Endocrinology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lene Surland', 'Initials': 'LS', 'LastName': 'Knudsen', 'Affiliation': 'Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Næstved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christoffer Grant', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13673']
1562,32748456,Comparison of two case difficulty assessment methods on cohorts of undergraduate dental students - a multi-centre study.,"AIM


To compare the educational benefits and user friendliness of two anonymized endodontic case difficulty assessment (CDA) methods.
METHODOLOGY


A cohort (n = 206) of fourth-year undergraduate dental students were recruited from four different Dental Schools and divided randomly into two groups (Group A and B). The participants assessed six test endodontic cases using anonymized versions of the American Association of Endodontists (AAE) case difficulty assessment form (AAE Endodontic Case Difficulty Assessment Form and Guidelines, 2006) and EndoApp, a web-based CDA tool. Group A (n = 107) used the AAE form for assessment of the first three cases, followed by EndoApp for the latter. Group B (n = 99) used EndoApp for the initial three cases and switched to the AAE form for the remainder. Data were collected online and analysed to assess participants' knowledge reinforcement and agreement with the recommendation generated. Statistical analysis was performed using the two-way mixed model anova, Cohen's Kappa (κ) and independent t-tests, with the levels of significance set at P < 0.05. Additionally, participants' feedback and preference for CDA was also gathered.
RESULTS


There was a significant increase in knowledge reinforcement for the AAE form and EndoApp (P = 0.001) after assessment of the first three test cases. However, this increase was not significant (P = 0.842) between the CDA methods. Overall, the AAE form and EndoApp had slight (κ = 0.176, P < 0.001) and substantial (κ = 0.668, P < 0.001) levels of agreement, respectively, and the difference was statistically significant (P < 0.001). Participants' feedback on user friendliness favoured EndoApp for all parameters measured. EndoApp was preferred by 65% of the cohort, whereas only 11% chose the AAE form for CDA.
CONCLUSIONS


Both the AAE form and EndoApp were beneficial for dental education. EndoApp was reliable in helping with decisions to treat or refer, and combined with user friendliness, it was the preferred choice for CDA.",2020,There was a significant increase in knowledge reinforcement for the AAE form and EndoApp (P = 0.001) after assessment of the first three test cases.,"['A cohort (n = 206) of fourth year undergraduate dental students were recruited from four different Dental Schools', 'cohorts of undergraduate dental students - a multi-centre study']",[],['knowledge reinforcement'],"[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0036376', 'cui_str': 'Dental School'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]",,0.0429236,There was a significant increase in knowledge reinforcement for the AAE form and EndoApp (P = 0.001) after assessment of the first three test cases.,"[{'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Shah', 'Affiliation': 'Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'H F', 'Initials': 'HF', 'LastName': 'Duncan', 'Affiliation': 'School of Dental Science, Trinity College Dublin, The University of Dublin, Dublin, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Abdullah', 'Affiliation': 'Faculty of Dentistry, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Tomson', 'Affiliation': 'School of Dentistry, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Murray', 'Affiliation': 'Private Practice, Dublin, Ireland.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Friend', 'Affiliation': 'Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Private Practice, Kent, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Butcher', 'Affiliation': 'Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Chong', 'Affiliation': 'Institute of Dentistry, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}]",International endodontic journal,['10.1111/iej.13377']
1563,32749474,Correction to Data in Trial of Convalescent Plasma Treatment for COVID-19.,,2020,,[],[],[],[],[],[],,0.0321843,,[],JAMA,['10.1001/jama.2020.13216']
1564,32752904,Peptide vaccine with glucopyranosyl lipid A-stable oil-in-water emulsion for patients with resected melanoma.,"Aim:  We tested the safety and immunogenicity of a novel vaccine in patients with resected high-risk melanoma.  Patients & methods:  HLA-A2-positive patients with resected Stage II-IV melanoma were randomized to receive up to three vaccinations of melanoma-associated peptide (MART-1a) combined with a stable oil-in-water emulsion (SE) either with the Toll-like receptor 4 agonist glucopyranosyl lipid A (GLA-SE-Schedule 1) or alone (SE-Schedule 2). Safety and immunogenicity of the vaccines were monitored.  Results:  A total of 23 patients were registered. No treatment-related grade 3 or higher adverse events were observed. Increases in MART-1a-specific T cells were seen in 70 and 63% of Schedule 1 and Schedule 2 patients, respectively.  Conclusion:  Both vaccine schedules were well-tolerated and resulted in an increase in MART-1a-specific T cells.  Clinical Trial registration:  NCT02320305 (ClinicalTrials.gov).",2020,"Increases in MART-1a-specific T cells were seen in 70 and 63% of Schedule 1 and Schedule 2 patients, respectively.  ","['A total of\xa023 patients were registered', 'Patients & methods:  HLA-A2-positive patients with resected Stage II-IV melanoma', 'patients with resected high-risk melanoma', 'patients with resected melanoma']","['agonist glucopyranosyl lipid A (GLA-SE-Schedule 1) or alone (SE-Schedule 2', 'novel vaccine', 'Peptide vaccine with glucopyranosyl lipid A-stable oil-in-water emulsion', 'melanoma-associated peptide (MART-1a) combined with a\xa0stable\xa0oil-in-water emulsion (SE) either with the Toll-like receptor 4']","['adverse events', 'MART-1a-specific T cells', 'Safety and immunogenicity', 'safety and immunogenicity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0019733', 'cui_str': 'HLA-A2 antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4276833', 'cui_str': 'glucopyranosyl lipid-A'}, {'cui': 'C0061078', 'cui_str': 'gamolenic acid'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0599934', 'cui_str': 'Peptide Vaccines'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",23.0,0.454163,"Increases in MART-1a-specific T cells were seen in 70 and 63% of Schedule 1 and Schedule 2 patients, respectively.  ","[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Grewal', 'Affiliation': 'Mayo Clinic Rochester, Division of Medical Oncology, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Erskine', 'Affiliation': 'Department of Immunology, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Nevala', 'Affiliation': 'Division of Oncology Research, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Jacob B', 'Initials': 'JB', 'LastName': 'Allred', 'Affiliation': 'Department of Biostatistics & Informatics, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Strand', 'Affiliation': 'Department of Biostatistics & Informatics, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kottschade', 'Affiliation': 'Mayo Clinic Rochester, Division of Medical Oncology, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'McWilliams', 'Affiliation': 'Mayo Clinic Rochester, Division of Medical Oncology, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Roxana S', 'Initials': 'RS', 'LastName': 'Dronca', 'Affiliation': 'Department of Hematology/Oncology, Mayo Clinic Jacksonville, 4500 San Pablo Road, Jacksonville, FL 32224, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Yakovich', 'Affiliation': 'Immune Design, Inc., 1616 Eastlake Ave E #310, Seattle, WA 98102, USA.'}, {'ForeName': 'Svetomir N', 'Initials': 'SN', 'LastName': 'Markovic', 'Affiliation': 'Mayo Clinic Rochester, Division of Medical Oncology, 200 First Street SW, Rochester, MN 55905, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Block', 'Affiliation': 'Mayo Clinic Rochester, Division of Medical Oncology, 200 First Street SW, Rochester, MN 55905, USA.'}]",Immunotherapy,['10.2217/imt-2020-0085']
1565,32755273,The acute effects of cannabidiol on the neural correlates of reward anticipation and feedback in healthy volunteers.,"BACKGROUND


Cannabidiol has potential therapeutic benefits for people with psychiatric disorders characterised by reward function impairment. There is existing evidence that cannabidiol may influence some aspects of reward processing. However, it is unknown whether cannabidiol acutely affects brain function underpinning reward anticipation and feedback.
HYPOTHESES


We predicted that cannabidiol would augment brain activity associated with reward anticipation and feedback.
METHODS


We administered a single 600 mg oral dose of cannabidiol and matched placebo to 23 healthy participants in a double-blind, placebo-controlled, repeated-measures design. We employed the monetary incentive delay task during functional magnetic resonance imaging to assay the neural correlates of reward anticipation and feedback. We conducted whole brain analyses and region-of-interest analyses in pre-specified reward-related brain regions.
RESULTS


The monetary incentive delay task elicited expected brain activity during reward anticipation and feedback, including in the insula, caudate, nucleus accumbens, anterior cingulate and orbitofrontal cortex. However, across the whole brain, we did not find any evidence that cannabidiol altered reward-related brain activity. Moreover, our Bayesian analyses showed that activity in our regions-of-interest was similar following cannabidiol and placebo. Additionally, our behavioural measures of motivation for reward did not show a significant difference between cannabidiol and placebo.
DISCUSSION


Cannabidiol did not acutely affect the neural correlates of reward anticipation and feedback in healthy participants. Future research should explore the effects of cannabidiol on different components of reward processing, employ different doses and administration regimens, and test its reward-related effects in people with psychiatric disorders.",2020,"However, across the whole brain, we did not find any evidence that cannabidiol altered reward-related brain activity.","['healthy volunteers', '23 healthy participants', 'people with psychiatric disorders', 'healthy participants', 'people with psychiatric disorders characterised by reward function impairment']","['single 600 mg oral dose of cannabidiol and matched placebo', 'placebo']","['brain activity during reward anticipation and feedback, including in the insula, caudate, nucleus accumbens, anterior cingulate and orbitofrontal cortex']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}]",23.0,0.374604,"However, across the whole brain, we did not find any evidence that cannabidiol altered reward-related brain activity.","[{'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Lawn', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Translational Psychiatry Research Group, University College London, London, UK.'}, {'ForeName': 'Chandni', 'Initials': 'C', 'LastName': 'Hindocha', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Yim', 'Affiliation': 'Translational Psychiatry Research Group, University College London, London, UK.'}, {'ForeName': 'Yumeya', 'Initials': 'Y', 'LastName': 'Yamamori', 'Affiliation': 'Translational Psychiatry Research Group, University College London, London, UK.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'Translational Psychiatry Research Group, University College London, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Walker', 'Affiliation': 'Translational Psychiatry Research Group, University College London, London, UK.'}, {'ForeName': 'Sebastian F', 'Initials': 'SF', 'LastName': 'Green', 'Affiliation': 'Translational Psychiatry Research Group, University College London, London, UK.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Wall', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Oliver D', 'Initials': 'OD', 'LastName': 'Howes', 'Affiliation': 'Psychiatric Imaging Group, Imperial College London, London, UK.'}, {'ForeName': 'H Valerie', 'Initials': 'HV', 'LastName': 'Curran', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Freeman', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}, {'ForeName': 'Michael Ap', 'Initials': 'MA', 'LastName': 'Bloomfield', 'Affiliation': 'Clinical Psychopharmacology Unit, University College London, London, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120944148']
1566,32758038,Dietary nitrate reduces blood pressure and cerebral artery velocity fluctuations and improves cerebral autoregulation in transient ischemic attack patients.,"Accentuated blood pressure (BP) fluctuation and low cerebral blood flow (CBF) response to CO 2  increase the risk of transient ischemic attack (TIA) recurrence and stroke in TIA patients. Improving cardio- and cerebrovascular function may reduce stroke risk. We found dietary nitrate lowered dynamic blood pressure variability (BPV) in rats and improved cerebrovascular CO 2  reactivity in healthy individuals. In 30 TIA patients, we examined the effects of a 7-day supplementation of dietary nitrate (0.1 mmol·kg -1 ·day -1 ) on cerebrovascular function using a randomized, single-blinded, placebo-controlled study design. We hypothesized that 7-day dietary nitrate supplementation would decrease variabilities in BP and CBF and improve CBF-CO 2  slope and cerebral autoregulation (CA). We assessed beat-to-beat middle cerebral artery blood velocity (MCAv; index of CBF) and BP at rest and during CO 2  breathing. Transfer function analysis was performed on beat-to-beat MCAv and BP to determine CA parameters (gain, phase, and coherence). Irrespective of treatment, high- and low-frequency BP-MCAv gain and MCAv-CO 2  slope increased 7 days following TIA onset, while low-frequency BPV decreased ( P  < 0.05 vs. baseline). At follow-up, dietary nitrate elevated plasma nitrate concentration by ~547% ( P  < 0.001) and moderately lowered BPV ( d  = 0.6,  P  = 0.011), MCAv variability ( d  = 0.7,  P  = 0.018), and BP-MCAv coherence ( d  = 0.7,  P  = 0.008) in the very-low-frequency range (0.02-0.07 Hz), while MCAv-CO 2  slope and arterial stiffness were unaffected ( P  > 0.05). Concurrent with standard treatment, dietary nitrate supplementation reduces BP and CBF fluctuation and improves cerebral autoregulation in TIA patients, without affecting cerebrovascular CO 2  reactivity. NEW & NOTEWORTHY  We found dietary nitrate supplementation reduced blood pressure and brain blood flow fluctuations and improved the relationship between blood pressure and brain blood flow in transient ischemic attack patients. Meanwhile, dietary nitrate had no effects on the brain blood vessels' response to CO 2 . We attribute the improved brain blood flow stability to the improved myogenic control of blood pressure with dietary nitrate. Our findings indicate that dietary nitrate could be an effective strategy for stabilizing blood pressure and brain blood flow following transient ischemic attack.",2020,"At follow-up, dietary nitrate elevated plasma nitrate concentration by ˜547% (p<0.001) and moderately lowered BPV (d=0.6, p=0.011), MCAv variability (d = 0.7, p = 0.018) and BP-MCAv coherence (d=0.7, p=0.008) in the very-low frequency range (0.02-0.07 Hz), while MCAv-CO 2  slope and arterial stiffness were unaffected (p>0.05).","['transient ischemic attack patients', 'TIA patients', 'thirty TIA patients', 'healthy individuals']","['dietary nitrate supplementation', 'Dietary nitrate', '7-day supplementation of dietary nitrate', '7-day dietary nitrate supplementation', 'placebo']","['beat-to-beat middle cerebral artery blood velocity (MCAv, index of CBF) and BP at rest and during CO 2  breathing', 'cerebral autoregulation', 'Accentuated blood pressure (BP) fluctuation and low cerebral blood flow (CBF) response', 'low frequency BPV', 'MCAv variability', 'BP-MCAv coherence', 'blood pressure and cerebral artery velocity fluctuations', 'variabilities in BP and CBF and improve CBF-CO 2  slope and cerebral autoregulation (CA', 'dynamic blood pressure variability (BPV', 'BPV', 'cerebrovascular function', 'dietary nitrate elevated plasma nitrate concentration', 'transient ischemic attack (TIA) recurrence and stroke', 'MCAv-CO 2  slope and arterial stiffness', 'BP and CBF fluctuation and improve cerebral autoregulation', 'high and low frequency BP-MCAv gain and MCAv-CO 2  slope']","[{'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C1997416', 'cui_str': 'Accentuated'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0006072', 'cui_str': 'Bovine papillomavirus'}, {'cui': 'C0007770', 'cui_str': 'Structure of cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}]",30.0,0.0556527,"At follow-up, dietary nitrate elevated plasma nitrate concentration by ˜547% (p<0.001) and moderately lowered BPV (d=0.6, p=0.011), MCAv variability (d = 0.7, p = 0.018) and BP-MCAv coherence (d=0.7, p=0.008) in the very-low frequency range (0.02-0.07 Hz), while MCAv-CO 2  slope and arterial stiffness were unaffected (p>0.05).","[{'ForeName': 'Jui-Lin', 'Initials': 'JL', 'LastName': 'Fan', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Terrence', 'Initials': 'T', 'LastName': ""O'Donnell"", 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Lanford', 'Affiliation': 'Department of Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Croft', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Eloise', 'Initials': 'E', 'LastName': 'Watson', 'Affiliation': 'Department of Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Smyth', 'Affiliation': 'Department of Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Koch', 'Affiliation': 'School of Biomedical Science, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Lai-Kin', 'Initials': 'LK', 'LastName': 'Wong', 'Affiliation': 'Department of Neurology, Wellington Regional Hospital, Wellington, New Zealand.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Tzeng', 'Affiliation': 'Wellington Medical Technology Group, Department of Surgery and Anaesthesia, University of Otago, Wellington, New Zealand.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00160.2020']
1567,32767806,R-CHOP-14 versus R-CHOP-14/CHASER for upfront autologous transplantation in diffuse large B-cell lymphoma: JCOG0908 study.,"The efficiency of upfront consolidation with high-dose chemotherapy/autologous stem-cell transplantation (HDCT/ASCT) for newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL) may be influenced by induction chemotherapy. To select better induction chemotherapy regimens for HDCT/ASCT, a randomized phase II study was conducted in high-risk DLBCL patients having an age-adjusted International Prognostic Index (aaIPI) score of 2 or 3. As induction chemotherapy, 6 cycles of R-CHOP-14 (arm A) or 3 cycles of R-CHOP-14 followed by 3 cycles of CHASER (arm B) were planned, and patients who responded proceeded to HDCT with LEED and ASCT. The primary endpoint was 2-y progression-free survival (PFS), and the main secondary endpoints included overall survival, overall response rate, and adverse events (AEs). In total, 71 patients were enrolled. With a median follow-up of 40.3 mo, 2-y PFS in arms A and B were 68.6% (95% confidence interval [CI], 50.5%-81.2%) and 66.7% (95% CI: 48.8%-79.5%), respectively. Overall survival at 2 y in arms A and B was 74.3% (95% CI: 56.4%-85.7%) and 83.3% (95% CI: 66.6%-92.1%). Overall response rates were 82.9% in arm A and 69.4% in arm B. During induction chemotherapy, 45.7% and 75.0% of patients in arms A and B, respectively, had grade ≥ 3 non-hematologic toxicities. One patient in arm A and 6 in arm B discontinued induction chemotherapy due to AEs. In conclusion, R-CHOP-14 showed higher 2-y PFS and less toxicity compared with R-CHOP-14/CHASER in patients with high-risk DLBCL, suggesting the former to be a more promising induction regimen for further investigations (UMIN-CTR, UMIN000003823).",2020,"Overall survival at 2 years in arms A and B were 74.3% (95% CI, 56.4-85.7%) and 83.3% (95% CI, 66.6-92.1%).","['71 patients were enrolled', 'high-risk DLBCL patients with age-adjusted International Prognostic Index (aaIPI) score 2 or 3', 'newly diagnosed high-risk diffuse large B-cell lymphoma (DLBCL']","['upfront consolidation with high-dose chemotherapy/autologous stem-cell transplantation (HDCT/ASCT', 'HDCT with LEED and ASCT']","['grade ≥3 non-hematologic toxicities', '2-year PFS', 'Overall survival', '2-year progression-free survival (PFS', '2-year PFS and less toxicity', 'Overall response rates', 'overall survival, overall response rate, and adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C1512894', 'cui_str': 'International Prognostic Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",71.0,0.277288,"Overall survival at 2 years in arms A and B were 74.3% (95% CI, 56.4-85.7%) and 83.3% (95% CI, 66.6-92.1%).","[{'ForeName': 'Yoshitoyo', 'Initials': 'Y', 'LastName': 'Kagami', 'Affiliation': 'Department of Hematology, Toyota Kosei Hospital, Toyota, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Imaizumi', 'Affiliation': 'Department of Hematology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Minauchi', 'Affiliation': 'Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Hematology, Saitama Cancer Center, Ina-cho, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Hematology, National Cancer Center East, Kashiwa, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Tsujimura', 'Affiliation': 'Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Hangaishi', 'Affiliation': 'Division of Hematology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Tominaga', 'Affiliation': 'Division of Hematology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Youko', 'Initials': 'Y', 'LastName': 'Suehiro', 'Affiliation': 'Department of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagasaki Medical Center, Ohmura, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Michihide', 'Initials': 'M', 'LastName': 'Tokuhira', 'Affiliation': 'Departments of Hematology, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuroda', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yakushijin', 'Affiliation': 'First Department of Internal Medicine, Ehime University Hospital, Toon, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kubota', 'Affiliation': 'Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Kisato', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'Department of Hematology, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Morishima', 'Affiliation': 'Second Department of Internal Medicine, University of the Ryukyus Hospital, Nishihara, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Maruyama', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomomitsu', 'Initials': 'T', 'LastName': 'Hotta', 'Affiliation': 'National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Morishima', 'Affiliation': 'Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Tsukasaki', 'Affiliation': 'Department of Hematology, International Medical Center, Saitama Medical University, Hidaka, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}]",Cancer science,['10.1111/cas.14604']
1568,32763435,Maxillary Lateral Incisor Injection Pain Using the Dentapen Electronic Syringe.,"INTRODUCTION


When patients express fear and anxiety about dentistry, 1 main source involves the administration of local anesthetic. The Dentapen (Septodont, Lancaster, PA) is a computer-controlled local anesthetic device that regulates the rate of anesthetic deposition to reduce pain associated with dental injections. The purpose of this study was to evaluate differences in perceived pain during the administration of local anesthesia of the maxillary lateral incisors using the ramp-up and continuous injection modes of the Dentapen.
METHODS


This study used a randomized, controlled, double-blind, crossover, experimental design. The investigators randomly assigned the order of the teeth (#7 or #10) and the 2 delivery modes (continuous or ramp-up). Participants completed a Corah dental anxiety scale at each visit and were injected on 2 separate visits at least 2 weeks apart. After each injection, participants rated their perceived pain using a Heft-Parker visual analog scale at needle insertion, needle placement, and solution deposition. Repeated measures analysis of variance was used to determine differences in perceived pain between the 2 modes.
RESULTS


The data from 116 participants were analyzed. The perceived pain at deposition with the ramp-up mode (mean = 51.98, standard deviation = 30.04) was less than the continuous mode (mean = 59.98, standard deviation = 36.28) although not statistically significant (F 1230  = 2.569, P > .05). Clinically, the perceived pain with the ramp-up mode was in the mild range (<54 mm), whereas the mean perceived pain with the continuous mode was in the moderate/severe range (>54 mm).
CONCLUSIONS


Further research should evaluate whether the ramp-up mode could be used to reduce the pain perceived with other dental injections.",2020,"The perceived pain at deposition with the ramp-up mode (M=51.98, sd=30.04) was less than the continuous mode (M=59.98, sd=36.28), although not statistically significant (F(1,230)=2.569, p>.05).",['116 participants were analyzed'],['Dentapen electronic syringe'],"[""Corah's dental anxiety scale"", 'perceived pain at deposition', 'Maxillary lateral incisor injection pain']","[{'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}]","[{'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}]",116.0,0.101603,"The perceived pain at deposition with the ramp-up mode (M=51.98, sd=30.04) was less than the continuous mode (M=59.98, sd=36.28), although not statistically significant (F(1,230)=2.569, p>.05).","[{'ForeName': 'Brian B', 'Initials': 'BB', 'LastName': 'Partido', 'Affiliation': 'Division of Dental Hygiene, The Ohio State University College of Dentistry, Columbus, Ohio. Electronic address: brian.partido@seattlecolleges.edu.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Nusstein', 'Affiliation': 'Division of Endodontics, The Ohio State University College of Dentistry, Columbus, Ohio.'}, {'ForeName': 'Kyerston', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Division of Dental Hygiene, The Ohio State University College of Dentistry, Columbus, Ohio.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Lally', 'Affiliation': 'Division of Dental Hygiene, The Ohio State University College of Dentistry, Columbus, Ohio.'}]",Journal of endodontics,['10.1016/j.joen.2020.07.029']
1569,32763640,Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness.,"BACKGROUND


Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, including ICU-related post-traumatic stress disorder (PTSD), depression and anxiety. As we encounter a growing number of ICU survivors, in particular in the wake of the coronavirus pandemic, clinicians must be equipped to understand the severity and prevalence of significant psychiatric complications of critical illness.
METHODS


We compared the efficacy of the ICU diary, written by family and healthcare workers during the patient's intensive care course, versus education alone in reducing acute PTSD symptoms after discharge. Patients with an ICU stay >72 h, who were intubated and mechanically ventilated over 24 h, were recruited and randomized to either receive a diary at bedside with psychoeducation or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7 was conducted at baseline within 1 week of ICU discharge and at weeks 4, 12, and 24 after ICU discharge. Change from baseline in these scores was assessed using Wilcoxon rank sum tests.
RESULTS


From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital. 60 patients were enrolled and randomized, of which 35 patients completed post-discharge follow-up, (n = 18) in the diary intervention group and (n = 17) in the education-only control group. The control group had a significantly greater decrease in PTSD, hyperarousal, and depression symptoms at week 4 compared to the intervention group. There were no significant differences in other measures, or at other follow-up intervals. Both study groups exhibited clinically significant PTSD symptoms at all timepoints after ICU discharge. Follow-up phone interviews with patients revealed that while many were interested in getting follow-up for their symptoms, there were many barriers to accessing appropriate therapy and clinical attention.
CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay. However, our study finds an important gap in clinical practice - patients at high risk for PICS are infrequently connected to appropriate follow-up care. Perhaps ICU diaries would prove beneficial if utilized to support the work within a program providing wrap-around services and close psychiatric follow up for PICS patients. This study demonstrates the high prevalence of ICU-related PTSD in our cohort of survivors, the high barrier to accessing care for appropriate treatment of PICS, and the consequence of that barrier-prolonged psychological morbidity.
TRIAL REGISTRATION


NCT04305353.
GRANT IDENTIFICATION


GH-17-022 (Arnold P. Gold Foundation).",2020,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","['From September 26, 2017 to September 25, 2018, our team screened 265 patients from the surgical and medical ICUs at a single large academic urban hospital', '60 patients', 'Patients with an ICU stay >72\u202fh, who were intubated and mechanically ventilated over 24\u202fh']","['intensive care unit (ICU) diary program', 'diary intervention group and (n\u202f=\u202f17) in the education-only control group', 'diary at bedside with psychoeducation or psychoeducation alone']","['acute PTSD symptoms', 'PTSD symptoms', 'PTSD, hyperarousal, and depression symptoms', 'Psychological symptom screening with IES-R, PHQ-8, HADS and GAD-7']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0747767', 'cui_str': 'Acute Post-Traumatic Stress Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}]",60.0,0.0503067,"CONCLUSIONS


Results from psychological screening tools demonstrate no benefit of ICU diaries versus bedside education-alone in reducing PTSD symptoms related to the intensive care stay.","[{'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Sayde', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: gsayde@tulane.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Stefanescu', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, 1440 Canal Street, New Orleans, LA 70122, USA. Electronic address: astefanescu@tulane.edu.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Conrad', 'Affiliation': 'Department of Psychiatry, Louisiana State University, 2025 Gravier Street, New Orleans, LA 70112, USA. Electronic address: econra@lsuhsc.edu.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, University of New Mexico School of Medicine, 1 University of New Mexico, Albuquerque, NM 87131, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hammer', 'Affiliation': 'Department of Internal Medicine and Psychiatry, Tulane University of School of Medicine, 1440 Canal Street, Suite 1000, New Orleans, LA 70112, USA. Electronic address: rhammer@tulane.edu.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.017']
1570,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
1571,32768592,Efficacy and safety of basiliximab as initial immunosuppression in liver transplantation: A single center study.,"INTRODUCTION AND AIM


The interleukin-2 receptor antagonist; basiliximab is used to allow delayed introduction of Calcineurin inhibitors (CNI) after liver transplantation and thus delay their renal insult. However, there is only little evidence for the safety and the efficacy of this regimen. This study aimed to evaluate the effectiveness and safety of basiliximab induction in liver transplantation.
MATERIALS AND METHODS


This study included 89 patients who were classified into two groups: standard triple immunosuppression (IS) regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF) (n = 47) and induction IS regimen of basiliximab, low dose steroids and MMF with delayed introduction of CNI (n = 42). All patients were followed after liver transplantation for at least six months or until death.
RESULTS


There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups. The acute rejection rate was equivalent in both groups. Renal dysfunction in the first six months post-transplant was less in the basiliximab group in comparison to the other group (7.1% and 19.1% respectively).
CONCLUSION


Basiliximab-induced IS protocol is a safe regimen that reduces medium-term renal dysfunction and achieves similar survival without increasing the acute rejection or infection rate in liver transplantation recipients.",2020,"There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups.","['liver transplantation recipients', '89 patients who were classified into two groups', 'Liver Transplantation']","['interleukin-2 receptor antagonist', 'Basiliximab', 'standard triple immunosuppression (IS) regimen of steroid, tacrolimus (TAC) and mycophenolate mofetil (MMF) (n\u2009=\u200947) and induction IS regimen of basiliximab, low dose steroids and MMF with delayed introduction of CNI', 'Basiliximab-induced IS protocol']","['Efficacy and Safety', 'Renal dysfunction', 'acute rejection rate', 'patient survival, graft dysfunction, infection rate or type, or wound healing']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",89.0,0.0258293,"There were no significant differences in patient survival, graft dysfunction, infection rate or type, or wound healing between both groups.","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hashim', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt. Electronic address: msaadhh@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Alsebaey', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Ragab', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Hossam Eldeen', 'Initials': 'HE', 'LastName': 'Soliman', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Waked', 'Affiliation': 'Department of Hepatology, National Liver Institute, Menoufiya University, Shebin Elkom, Egypt.'}]",Annals of hepatology,['10.5604/01.3001.0012.2246']
1572,32770616,Caesarean section in the second delivery to prevent anal incontinence after asymptomatic obstetric anal sphincter injury: the EPIC multicentre randomised trial.,"OBJECTIVE


To determine whether planned caesarean section (CS) for a second delivery protects against anal incontinence in women with obstetric anal sphincter lesions.
DESIGN


Randomised trial.
SETTING


Six maternity units in the Paris area.
SAMPLE


Women at high risk of sphincter lesions (first delivery with third-degree laceration and/or forceps) but no symptomatic anal incontinence.
METHODS


Endoanal ultrasound was performed in the third trimester of the second pregnancy. Women with sphincter lesions were randomised to planned CS or vaginal delivery (VD).
MAIN OUTCOME MEASURES


Anal incontinence at 6 months postpartum. Secondary outcomes were urinary incontinence, sexual morbidity, maternal and neonatal morbidities and worsening of external sphincter lesions.
RESULTS


Anal sphincter lesions were detected by ultrasound in 264/434 women enrolled (60.8%); 112 were randomised to planned VD and 110 to planned CS. At 6-8 weeks after delivery, there was no significant difference in anal continence between the two groups. At 6 months after delivery, median Vaizey scores of anal incontinence were 1 (interquartile range 0-4) in the CS group and 1 (interquartile range 0-3) in the VD group (P = 0.34). There were no significant differences for urinary continence, sexual functions or for other maternal and neonatal morbidities.
CONCLUSIONS


In women with asymptomatic obstetric anal sphincter lesions diagnosed by ultrasound, planning a CS had no significant impact on anal continence 6 months after the second delivery. These results do not support advising systematic CS for this indication.
TWEETABLE ABSTRACT


Caesarean section for the second delivery did not protect against anal incontinence in women with asymptomatic obstetric anal sphincter lesions.",2020,"In women with asymptomatic obstetrical anal sphincter lesions diagnosed by ultrasound, planning a CS had no significant impact on anal continence 6 months after the second delivery.","['SAMPLE\n\n\nWomen at high risk of sphincter lesions (first delivery with 3d degree laceration and/or forceps', 'women with asymptomatic obstetrical anal sphincter lesions', ' 6 maternity units in the Paris area', 'Anal sphincter lesions were detected by ultrasound in 264/434 women enrolled (60.8%) ; 112', 'asymptomatic obstetrical anal sphincter injury', 'Women with sphincter lesions', 'women with obstetrical anal sphincter lesions']","['planned cesarean section (CS', 'planned CS or vaginal delivery (VD', 'Endoanal ultrasound', 'Cesarean section']","['urinary continence, sexual functions or for other maternal and neonatal morbidities', 'median Vaizey scores of anal continence', 'Anal continence', 'anal incontinence', 'urinary continence, sexual morbidity, maternal and neonatal morbidities and worsening of external sphincter lesions', 'anal continence']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0002760', 'cui_str': 'Structure of sphincter ani muscle'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1142258', 'cui_str': 'Anal sphincter injury'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0542565', 'cui_str': 'Bladder control'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1290944', 'cui_str': 'Anorectal continence'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",112.0,0.119998,"In women with asymptomatic obstetrical anal sphincter lesions diagnosed by ultrasound, planning a CS had no significant impact on anal continence 6 months after the second delivery.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Abramowitz', 'Affiliation': 'Hôpital Bichat, Proctology Unit, Department of Gastroenterology, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mandelbrot', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hôpital Louis-Mourier, Assistance Publique-Hôpitaux de Paris, Colombes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourgeois Moine', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Tohic', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre Hospitalier de Versailles, Le Chesnay, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carne Carnavalet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hôpital Armand Trousseau, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Poujade', 'Affiliation': 'Department of Obstetrics and Gynaecology Assistance Publique-Hôpitaux de Paris, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roy', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tubach', 'Affiliation': ""Département de Santé Publique, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris, France.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16452']
1573,32768682,Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.,"Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.",2020,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","['adults with mobility related disabilities', 'adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an', '128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between', 'Adults with mobility related disabilities (MRDs']","['Weight management', 'enhanced Stop Light Diet (eSLD', 'interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing']","['quality of life', 'weight loss', 'physical activity, sleep quality, and medications on weight change', 'meaningful weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0419181', 'cui_str': 'Light diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",128.0,0.0374796,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@kumc.edu.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Smith', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: psmith18@kumc.edu.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: mmayo@kumc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106098']
1574,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1575,32771088,"Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study.","BACKGROUND


Poly (ADP-ribose) polymerase inhibitors combined with immunotherapy have shown antitumour activity in preclinical studies. We aimed to assess the safety and activity of olaparib in combination with the PD-L1-inhibitor, durvalumab, in patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer.
METHODS


The MEDIOLA trial is a multicentre, open-label, phase 1/2, basket trial of durvalumab and olaparib in solid tumours. Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer. Here, we report on the cohort of patients with breast cancer. Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea. Patients should not have received more than two previous lines of chemotherapy for metastatic breast cancer. Patients received 300 mg olaparib in tablet form orally twice daily for 4 weeks and thereafter a combination of olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion every 4 weeks until disease progression. Primary endpoints were safety and tolerability, and 12-week disease control rate. Safety was analysed in patients who received at least one dose of study treatment, and activity analyses were done in the full-analysis set (patients who received at least one dose of study treatment and were not excluded from the study). Recruitment has completed and the study is ongoing. This trial is registered with ClinicalTrials.gov, NCT02734004.
FINDINGS


Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis. 11 (32%) patients experienced grade 3 or worse adverse events, of which the most common were anaemia (four [12%]), neutropenia (three [9%]), and pancreatitis (two [6%]). Three (9%) patients discontinued due to adverse events and four (12%) patients experienced a total of six serious adverse events. There were no treatment-related deaths. 24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
INTERPRETATION


Combination of olaparib and durvalumab showed promising antitumour activity and safety similar to that previously observed in olaparib and durvalumab monotherapy studies. Further research in a randomised setting is needed to determine predictors of therapeutic benefit and whether addition of durvalumab improves long-term clinical outcomes compared with olaparib monotherapy.
FUNDING


AstraZeneca.",2020,"24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
","['Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea', 'in solid tumours', 'Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer', 'patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer', 'Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis', 'patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA', 'patients with breast cancer']","['olaparib', 'Olaparib and durvalumab', 'olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion', 'durvalumab and olaparib', 'durvalumab', 'chemotherapy']","['Safety', 'neutropenia', 'total of six serious adverse events', 'anaemia', 'grade 3 or worse adverse events', 'safety and tolerability, and 12-week disease control rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C2973986', 'cui_str': 'BRCA2 protein, human'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4721779', 'cui_str': 'Ovarian cancer stage IV'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",34.0,0.187663,"24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks.
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Domchek', 'Affiliation': 'Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: susan.domchek@pennmedicine.upenn.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Postel-Vinay', 'Affiliation': 'ATIP -Avenir group, Inserm Unit U981, Villejuif, France; Faculté de Médicine, Le Kremlin Bicêtre, Université Paris Saclay, Université Paris-Sud, Villejuif, France; Department of Drug Development, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of South Korea.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of South Korea.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse, Toulouse, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Alexandre', 'Affiliation': 'Hôpital Cochin, Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'You', 'Affiliation': ""Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon, Centre d'Investigation de Therapeutiques en Oncologie et H ematologie de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France; Faculté de Médecine Lyon-Sud, Univ Lyon, Université Claude Bernard Lyon 1, EMR UCBL/HCL 3738, Lyon, France; Groupe des Investigateurs Nationaux pour les Cancers de l Ovaire et du sein-GINEGEPS, Paris, France.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bastian', 'Affiliation': 'Kantonsspital Graubuenden, Chur, Switzerland.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Krebs', 'Affiliation': 'Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK; Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Henry Ford Medical Center, Detroit, MI, USA.'}, {'ForeName': 'Saiama N', 'Initials': 'SN', 'LastName': 'Waqar', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lanasa', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Rhee', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Vidalba', 'Initials': 'V', 'LastName': 'Rocher-Ros', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Jones', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sakshi', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Coenen-Stass', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Iwanka', 'Initials': 'I', 'LastName': 'Kozarewa', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Zhongwu', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Angell', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Opincar', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Herbolsheimer', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Kaufman', 'Affiliation': 'Chaim Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30324-7']
1576,32776722,Performance of a Community-based Noncommunicable Disease Control Program in Korea: Patients 65 Years of Age or Older.,"BACKGROUND


In Korea, the Korean Community-based Noncommunicable Disease Prevention and Control Program (KCNPC) was implemented in 2012 for the management of patients with chronic diseases. Nineteen primary care clinics, public health centers, and education and consulting centers (ECCs) participated in the implementation of this program. This study assessed the effectiveness of this chronic disease control model by comparing mortality rate and the incidence of complications between patients participating in the KCNPC program and a control group.
METHODS


Using data from the National Health Insurance Service and data from hypertension and diabetes patients registered with 19 ECCs between January 1, 2010 and December 31, 2012, hypertension and diabetes patients who had been treated at a clinic were selected. The final analysis included 252,900 patients, with the intervention group and control group having 126,450 patients each. Survival for the two groups was analyzed using the Kaplan-Meier method. Complications were analyzed using the Cox proportional hazards model.
RESULTS


The 5-year survival rate in the intervention group (0.88) was higher than that in the control group (0.86). Cox proportional hazards analysis showed that the intervention group had lower risk for mortality (0.84; 95% confidence interval [CI], 0.82-0.86) compared to the control group. Hospitalization due to complications and the proportional risk of hospitalization were also lower in the intervention group.
CONCLUSION


The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients. Therefore, the KCNPC will be necessary to strengthen the capabilities of local communities, primary medical institutions, and individuals for prevention and control of chronic disease. Expanding the efficient prevention and control policies of the KCNPC to a nationwide scale may be effective as has been demonstrated through limited implementation in some regions.",2020,The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients.,"['Korea: Patients 65 Years of Age or Older', 'patients registered with 19 ECCs between January 1, 2010 and December 31, 2012, hypertension and diabetes patients who had been treated at a clinic were selected', 'Nineteen primary care clinics, public health centers, and education and consulting centers (ECCs) participated in the implementation of this program', '252,900 patients, with the intervention group and control group having 126,450 patients each', 'patients with chronic diseases', 'Using data from the National Health Insurance Service and data from hypertension and diabetes', 'patients participating in the KCNPC program and a control group']","['Community-based Noncommunicable Disease Control Program', 'Control Program (KCNPC', 'KCNPC']","['5-year survival rate', 'Survival', 'lower risk for mortality', 'mortality rate and the incidence of complications', 'proportional risk of hospitalization']","[{'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",252900.0,0.0179266,The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients.,"[{'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Sung Hyo', 'Initials': 'SH', 'LastName': 'Seo', 'Affiliation': 'Department of Information Statistics, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Ki Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, College of Medicine and Institute of Health Science, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Hwangbo', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Yeonok', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Department of Nursing, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Sungin', 'Initials': 'S', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jeongmook', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Hyeonji', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jose Rene Bagani', 'Initials': 'JRB', 'LastName': 'Cruz', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Yoon Hyung', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea. parky@sch.ac.kr.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e268']
1577,32778008,Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy.,"Objective:  This study examined how the lower cognitive skills in children who consumed iron-fortified formula in infancy relate to outcomes in young adulthood.  Methods:  Participants were 443 Chilean young adults ( M  age = 21.2y, 55% female) who took part in a randomized controlled iron-deficiency anemia preventive trial during infancy (6-12 m). Slightly over half of participants ( n  = 237) received iron-fortified formula (12.7 mg/L) and 206 received a low-iron formula (2.3 mg/L). Spatial memory, IQ, and visual-motor integration were measured at age 10, and neurocognition, emotion regulation, educational level, and attainment of adult developmental milestones were assessed at age 21.  Results:  Consumption of iron-fortified formula in infancy was associated with poorer performance on neurocognitive tests in childhood, and these effects related to poorer neurocognitive, emotional, and educational outcomes in young adulthood. Dosage effects associated with consumption of iron-fortified formula were found for lower educational attainment and, marginally, slower mental processing. Those who received iron-fortified formula and had low age 10 cognitive abilities performed most poorly on neurocognitive tests at age 21.  Conclusion:  Findings suggest that the long-term development of infants who consume iron-fortified formula may be adversely affected. Clinical Trials number: NCT01166451.",2020,"Dosage effects associated with consumption of iron-fortified formula were found for lower educational attainment and, marginally, slower mental processing.","['Participants were 443 Chilean young adults ( M  age\u2009=\u200921.2y, 55% female) who took part in a randomized controlled iron-deficiency anemia preventive trial during infancy (6-12\u2005m', 'young adulthood', 'children who consumed iron-fortified formula in infancy relate to outcomes in young adulthood']","['low-iron formula', 'iron-fortified formula']","['Spatial memory, IQ, and visual-motor integration', 'neurocognition, emotion regulation, educational level, and attainment of adult developmental milestones', 'poorer neurocognitive, emotional, and educational outcomes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0860975', 'cui_str': 'Iron low'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}]","[{'cui': 'C0814087', 'cui_str': 'Spatial Memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",443.0,0.117798,"Dosage effects associated with consumption of iron-fortified formula were found for lower educational attainment and, marginally, slower mental processing.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'East', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jenalee', 'Initials': 'J', 'LastName': 'Doom', 'Affiliation': 'Department of Psychology, University of Denver, Denver, CO, USA.'}, {'ForeName': 'Estela', 'Initials': 'E', 'LastName': 'Blanco', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Burrows', 'Affiliation': 'Institute of Nutrition and Food Technology, University of Chile, Santiago, Chile.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Lozoff', 'Affiliation': 'Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Gahagan', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, CA, USA.'}]",Nutritional neuroscience,['10.1080/1028415X.2020.1804099']
1578,32773601,A combination of pain indices based on momentary assessments can predict placebo response in patients with fibromyalgia syndrome.,"Many factors are known to affect assay sensitivity; however, limited attention has been devoted to understanding whether characteristics of patients' baseline pain impact assay sensitivity. In this study, we tested whether a combination of 3 baseline pain indices based on ecological momentary assessments (EMA) could detect patients with enhanced responses to placebo. The analysis was conducted with secondary data from 2 clinical trials in fibromyalgia patients (N = 2084). For each patient, pain intensity, pain variability (individual SD), and pain consistency (first-order autocorrelation) were computed from baseline EMA. A latent profile analysis identified 3 subgroups of patients based on these indices. Group 1 (n = 857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain. Group 3 (n = 110, 5.3%) showed the opposite pattern, and group 2 (n = 1109, 53.4%) showed intermediate levels on all pain indices. It was then tested whether the subgroups moderated treatment effects (changes in pain for active treatment vs placebo) using repeated-measures analysis of variance. Treatment effects varied significantly between subgroups. Patients in group 3 demonstrated greater reduction in pain in response to placebo then those in groups 1 and 2. Further analysis showed that the removal of patients in class 3 would significantly enhance the observed treatment effect by 8% to 15%. In conclusion, profiles of pain characteristics derived from baseline EMA may be useful for detecting patient subgroups with enhanced placebo responses that can diminish assay sensitivity in pain clinical trials.",2020,"Group 1 (n=857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain.","['fibromyalgia patients (N=2084', 'patients with fibromyalgia syndrome']",['placebo'],"['variability of pain', 'pain intensity, pain variability (individual standard deviation), and pain consistency (first-order autocorrelation', 'lowest pain intensity levels', 'intermediate levels on all pain indices', 'pain']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.232416,"Group 1 (n=857, 41.3%) showed the lowest pain intensity levels, coupled with the highest consistency and greatest variability of pain.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Obbarius', 'Affiliation': 'Dornsife Center for Self-Report Science, Center for Economic & Social Research, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Dornsife Center for Self-Report Science, Center for Economic & Social Research, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Arthur A', 'Initials': 'AA', 'LastName': 'Stone', 'Affiliation': 'Dornsife Center for Self-Report Science, Center for Economic & Social Research, University of Southern California, Los Angeles, CA, United States.'}]",Pain,['10.1097/j.pain.0000000000002025']
1579,32781894,Conventional versus minimally invasive extracorporeal circulation in patients undergoing cardiac surgery: protocol for a randomised controlled trial (COMICS).,"INTRODUCTION


Despite low mortality, cardiac surgery patients may experience serious life-threatening post-operative complications, often due to extracorporeal circulation and reperfusion. Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
METHODS


The COMICS trial is a multi-centre, international, two-group parallel randomised controlled trial testing whether type II, III or IV minimally invasive extracorporeal circulation is effective and cost-effective compared to conventional extracorporeal circulation in patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting + aortic valve replacement. Randomisation (1:1 ratio) is concealed and stratified by centre and surgical procedure. The primary outcome is a composite of 12 serious complications, objectively defined or adjudicated, 30 days after surgery. Secondary outcomes (at 30 days) include other serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90 days).
STATUS OF THE TRIAL


Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020). The recruitment rate from 01 April 2019 to 31 March 2020 was 40-50 patients/month. About 80% have had coronary artery bypass grafting only. Adherence to allocation is good.
CONCLUSIONS


The trial is feasible but criteria for progressing to a full trial were not met on time. The Trial Steering and Data Monitoring Committees have recommended that the trial should currently continue.",2020,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","['patients undergoing elective or urgent coronary artery bypass grafting, aortic valve replacement or coronary artery bypass grafting\u2009+\u2009aortic valve replacement', 'patients undergoing cardiac surgery', 'Two centres started recruiting on 08 May 2018; 10 are currently recruiting and 603 patients have been randomised (11 May 2020']","['Conventional versus minimally invasive extracorporeal circulation', 'Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation', 'conventional extracorporeal circulation']","['composite of 12 serious complications', 'serious adverse events (primary safety outcome), use of blood products, length of intensive care and hospital stay and generic health status (also at 90\u2009days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0015354', 'cui_str': 'Extracorporeal circulation procedure'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.169333,"Miniaturised cardiopulmonary bypass (minimally invasive extracorporeal circulation) has been developed aiming to reduce the risk of post-operative complications arising with conventional extracorporeal circulation.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'C Reeves', 'Affiliation': 'University of Bristol'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'University of Bristol'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'A Culliford', 'Affiliation': 'University of Bristol'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Collett', 'Affiliation': 'University of Bristol'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'A Rogers', 'Affiliation': 'University of Bristol'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stokes', 'Affiliation': 'University of Oxford'}, {'ForeName': 'Kyriakos', 'Initials': 'K', 'LastName': 'Anastasiadis', 'Affiliation': 'AHEPA University Hospital'}, {'ForeName': 'Polychronis', 'Initials': 'P', 'LastName': 'Antonitsis', 'Affiliation': 'AHEPA University Hospital'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Carrel', 'Affiliation': 'University Hospital Bern'}, {'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Keller', 'Affiliation': 'University Hospital Bern'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Liebold', 'Affiliation': 'Universitätsklinikum Ulm'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ashkanani', 'Affiliation': 'Universitätsklinikum Ulm'}, {'ForeName': 'Aschraf', 'Initials': 'A', 'LastName': 'El-Essawi', 'Affiliation': 'Universitätsmedizin Göttingen'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Breitenbach', 'Affiliation': 'Klinikum Braunschweig'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'University Hospitals Plymouth NHS Trust'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bennett', 'Affiliation': 'University Hospitals Plymouth NHS Trust'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Cale', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Mclean', 'Affiliation': 'Hull University Teaching Hospitals NHS Trust'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Gunaydin', 'Affiliation': 'Numune Training and Research Hospital in Ankara'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Gunertem', 'Affiliation': 'Numune Training and Research Hospital in Ankara'}, {'ForeName': 'Farouk', 'Initials': 'F', 'LastName': 'Oueida', 'Affiliation': 'Saud Al-Babtain Cardiac Centre'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Yassin', 'Affiliation': 'Saud Al-Babtain Cardiac Centre'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Serrick', 'Affiliation': 'University Health Network Toronto'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Rao', 'Affiliation': 'University Health Network Toronto'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moscarelli', 'Affiliation': 'Anthea Hospital, Bari'}, {'ForeName': 'Ignazzo', 'Initials': 'I', 'LastName': 'Condello', 'Affiliation': 'Anthea Hospital, Bari'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Punjabi', 'Affiliation': 'Imperial College Healthcare'}, {'ForeName': 'Cha', 'Initials': 'C', 'LastName': 'Rajakaruna', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bone', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lansdown', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust'}, {'ForeName': 'Narain', 'Initials': 'N', 'LastName': 'Moorjani', 'Affiliation': 'Royal Papworth Hospita'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dennis', 'Affiliation': 'Royal Papworth Hospita'}]",Perfusion,['10.1177/0267659120946731']
1580,32781920,Effect of ambient temperature on fat oxidation during an incremental cycling exercise test.,"Aim:  The objective of this current research was to compare fat oxidation rates during an incremental cycling exercise test in a temperate vs. hot environment.  Methods:  Twelve healthy young participants were recruited for a randomised crossover experimental design. Each participant performed a VO 2max  test in a thermoneutral environment followed by two cycling ramp test trials, one in a temperate environment (18.3°C) and another in a hot environment (36.3°C). The ramp test consisted of 3-min stages of increasing intensity (+10% of VO 2max ) while gas exchange, heart rate and perceived exertion were measured.  Results:  During exercise, there was a main effect of the environment temperature on fat oxidation rate ( F  = 9.35,  P  = 0.014). The rate of fat oxidation was lower in the heat at 30% VO 2max  (0.42 ± 0.15 vs.0.37 ± 0.13 g/min;  P  = 0.042), 60% VO 2max  (0.37 ± 0.27 vs.0.23 ± 0.23 g/min;  P  = 0.018) and 70% VO 2max  (0.22 ± 0.26 vs.0.12 ± 0.26 g/min;  P  = 0.007). In addition, there was a tendency for a lower maximal fat oxidation rate in the heat (0.55 ± 0.2 vs.0.48 ± 0.2 g/min;  P  = 0.052) and it occurred at a lower exercise intensity (44 ± 14 vs.38% ± 8% VO 2max ;  P  = 0.004). The total amount of fat oxidised was lower in the heat (5.8 ± 2.6 vs 4.6 ± 2.8 g;  P  = 0.002). The ambient temperature also produced main effects on heart rate ( F  = 15.18,  P  = 0.005) and tympanic temperature ( F  = 25.23,  P  = 0.001) with no effect on energy expenditure ( F  = 0.01,  P  = 0.945).  Conclusion:  A hot environment notably reduced fat oxidation rates during a ramp exercise test. Exercising in the heat should not be recommended for those individuals seeking to increase fat oxidation during exercise.",2020,"The ambient temperature also produced main effects on heart rate (F=15.18, P=0.005) and tympanic temperature (F=25.23, P=0.001) with no effect on energy expenditure (F=0.01, P=0.945).  ",['Twelve healthy young participants'],['ambient temperature'],"['total amount of fat oxidized', 'fat oxidation rates', 'tympanic temperature', 'energy expenditure', 'maximal fat oxidation rate', 'heart rate', 'fat oxidation', 'rate of fat oxidation', 'fat oxidation rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0542496', 'cui_str': 'Ambient temperature'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",12.0,0.0585768,"The ambient temperature also produced main effects on heart rate (F=15.18, P=0.005) and tympanic temperature (F=25.23, P=0.001) with no effect on energy expenditure (F=0.01, P=0.945).  ","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ruíz-Moreno', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gutiérrez-Hellín', 'Affiliation': 'Exercise and Sport Sciences, Faculty of Health Sciences, Francisco de Vitoria University, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'González-García', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Giráldez-Costas', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Brito De Souza', 'Affiliation': 'Exercise Physiology Laboratory, Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1809715']
1581,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1582,32761500,"Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study.","BACKGROUND


Botulinum toxin (BTX) is a potent neurotoxin with a long history of therapeutic application in neurological and dermatological conditions, with a strong efficacy and safety profile.
OBJECTIVE


Our aim was to assess whether intradermal injection with BTX-B is an effective treatment for hidradenitis suppurativa (HS).
METHODS


Twenty patients with HS stage I-III disease, according to Hurley's classification, were consecutively included for treatment with either a placebo or BTX-B. At the next intervention after 3 months, all participants received the active substance and another follow-up at 6 months. The primary outcome was quality of life, measured using the Dermatology Life Quality Index (DLQI), while secondary outcomes were the visual analogue scale (VAS) for pain in the worst boil and HS-related impairment of general health (VAS), as well as changes in physician-reported disease activity assessed as the number of total lesions, and reported adverse effects of treatment.
RESULTS


The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05). Improvement of the patients' own ratings of symptoms and a reduction in total lesions supplemented the primary outcome. Fifty-five percent of the study population reported some degree of hyperhidrosis.
CONCLUSION


BTX-B improves the quality of life in patients with HS. Furthermore, comorbidity between HS and hyperhidrosis is suggested.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03103074.",2020,"The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05).","[""Twenty patients with HS stage I-III disease, according to Hurley's classification, were consecutively included for treatment with either a"", 'patients with HS', 'Hidradenitis Suppurativa']","['placebo or BTX-B', 'Placebo', 'Botulinum toxin (BTX', 'Botulinum Toxin Type B', 'BTX-B', 'intradermal injection with BTX-B', 'placebo']","['DLQI', 'quality of life', 'visual analogue scale (VAS) for pain in the worst boil and HS-related impairment of general health (VAS), as well as changes in physician-reported disease activity assessed as the number of total lesions, and reported adverse effects of treatment', 'quality of life, measured using the Dermatology Life Quality Index (DLQI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0006051', 'cui_str': 'Botulinum Toxin Type B'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0242301', 'cui_str': 'Furuncle'}, {'cui': 'C0162836', 'cui_str': 'Hidradenitis suppurativa'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.500004,"The DLQI improved from a median of 17 at baseline to 8 at 3 months in the BTX-B group, compared with a reduction from 13.5 to 11 in the placebo group (p <0.05).","[{'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Grimstad', 'Affiliation': 'Department of Dermatology, University Hospital of North Norway, Tromsö, Norway. oystein.grimstad@unn.no.'}, {'ForeName': 'Bjørn Øivind', 'Initials': 'BØ', 'LastName': 'Kvammen', 'Affiliation': 'Department of Dermatology, University Hospital of North Norway, Tromsö, Norway.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Swartling', 'Affiliation': 'Hidrosis Clinic, Stockholm, Sweden.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00537-9']
1583,32761737,The effect of a low glycaemic index diet on reducing day-long glycaemia in healthy young adults: A randomized crossover trial.,"AIM


To compare the effect of a low glycaemic index (LGI) diet on reducing day-long glycaemia with a macronutrient-matched high glycaemic index (HGI) diet, using customized meal delivery to ensure compliance.
MATERIALS AND METHODS


We conducted a single-blinded, randomized crossover trial in 14 healthy adults (57% female) with a mean ± SD age of 21.6 ± 1.7 years. A flash glucose monitoring sensor was installed on the subjects on day 1 to capture the interstitial glucose level every 15 minutes for 14 days. Subjects were randomized to receive an LGI (dietary GI = 40) or HGI (dietary GI = 60) diet (three meals and two snacks) from day 2 for 5 consecutive days, followed by a 2-day washout, then switched to the alternative diet for another 5 days. A paired t-test was used to test the differences in the incremental area under the curve (iAUC) of glucose, postprandial glucose (PPG) concentration and maximum postprandial glucose rise (MPGR) between the LGI and HGI periods.
RESULTS


Subjects had lower iAUC for average day-long glycaemia during the LGI intervention period compared with the HGI period (mean ± SD, 865 ± 297 vs. 1024 ± 267 mmol x min/L; P = .047). PPG for breakfast and snack 2, and MPGR for breakfast, snack 2 and dinner, were lower in the LGI period.
CONCLUSIONS


In young healthy adults, following an LGI diet resulted in lower average day-long glycaemia compared with a macronutrient-matched HGI diet. Our results support the use of LGI diets to reduce the risk of developing glucose intolerance.",2020,"RESULTS


Subjects had lower iAUC for average daylong glycemia during the LGI intervention period compared with the HGI period (mean ± SD, 865 ± 297 vs. 1024 ± 267 mmol * min/L; p = 0.047).","['14 healthy adults (57% female) with a mean ± SD age of 21.6 ±\u20091.7\u2009years', 'young healthy adults', 'healthy young adults']","['LGI diets', 'LGI diet', 'low glycemic index (LGI) diet', 'LGI (dietary GI\xa0=\xa040) or HGI (dietary GI\xa0', 'low glycemic index diet']","['incremental area-under-curve (iAUC) of glucose, postprandial glucose concentration (PPG) and maximum postprandial glucose rise (MPGR', 'average daylong glycemia', 'daylong glycemia', 'risk of developing glucose intolerance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]",14.0,0.0429868,"RESULTS


Subjects had lower iAUC for average daylong glycemia during the LGI intervention period compared with the HGI period (mean ± SD, 865 ± 297 vs. 1024 ± 267 mmol * min/L; p = 0.047).","[{'ForeName': 'Hannah Wing Han', 'Initials': 'HWH', 'LastName': 'Hon', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tommy Hon Ting', 'Initials': 'THT', 'LastName': 'Wong', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Iris Mei Ying', 'Initials': 'IMY', 'LastName': 'Tse', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jimmy Chun Yu', 'Initials': 'JCY', 'LastName': 'Louie', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14167']
1584,32758455,"Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study.","BACKGROUND


Debio 1143 is an orally available antagonist of inhibitor of apoptosis proteins with the potential to enhance the antitumour activity of cisplatin and radiotherapy. The radiosensitising effect of Debio 1143 is mediated through caspase activation and TNF, IFNγ, CD8 T cell-dependent pathways. We aimed to investigate the efficacy and safety of Debio 1143 in combination with standard chemoradiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck.
METHODS


This double-blind, multicentre, randomised, phase 2 study by the French Head and Neck Radiotherapy Oncology Group (GORTEC) was run at 19 hospitals in France and Switzerland. Eligible patients were aged 18-75 years with locoregionally advanced, squamous cell carcinoma of the head and neck (characterised as non-metastatic, measurable stage III, IVa, or IVb [limited to T ≥2, N0-3, and M0] disease), Eastern Cooperative Oncology Group performance status of 0 or 1, a history of heavy tobacco smoking (>10 pack-years) with no previous or current treatment for invasive head and neck cancer, and no previous treatment with inhibitor of apoptosis protein antagonists. Patients were randomly assigned (1:1) to receive oral Debio 1143 (200 mg per day on days 1-14 of 21-day cycles, for three cycles) or oral placebo (20 mg/mL, administered at the same dosing schedule) using a stochastic minimisation technique according to node involvement and primary tumour site, and HPV-16 status in patients with an oropharyngeal primary tumour site. All patients received standard high-dose cisplatin chemoradiotherapy. The primary endpoint was the proportion of patients with locoregional control 18 months after chemoradiotherapy, analysed in the intention-to-treat population (primary analysis), and repeated in the per-protocol population. Responses were assessed according to Response Evaluation Criteria in Solid Tumors (version 1.1). This trial is registered with ClinicalTrials.gov, NCT02022098, and is still active but not recruiting.
FINDINGS


Between Jan 25, 2016, and April 24, 2017, 48 patients were randomly assigned to the Debio 1143 group and 48 to the placebo group (one patient in the placebo group did not receive the study drug and was not included in the safety analysis). Median duration of follow-up was 25·0 months (IQR 19·6-29·4) in the Debio 1143 group and 24·2 months (6·6-26·8) in the placebo group. Locoregional control 18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026). Grade 3 or worse adverse events were reported in 41 (85%) of 48 patients in the Debio 1143 group and in 41 (87%) of 47 patients in the placebo group. The most common grade 3-4 adverse events were dysphagia (in 24 [50%] patients in the Debio 1143 group vs ten [21%] in the placebo group), mucositis (in 15 [31%] vs ten [21%]), and anaemia (in 17 [35%] vs 11 [23%]). Serious treatment-emergent adverse events were recorded in 30 (63%) of 48 patients in the Debio 1143 group and 28 (60%) of 47 in the placebo group. In the placebo group, two (4%) deaths were due to adverse events (one multiple organ failure and one asphyxia; neither was considered to be related to treatment). No deaths due to adverse events occurred in the Debio 1143 group.
INTERPRETATION


To our knowledge, this is the first treatment regimen to achieve superior efficacy in this disease setting against a high-dose cisplatin chemoradiotherapy comparator in a randomised trial. These findings suggest that inhibition of inhibitor of apoptosis proteins is a novel and promising approach in this poor prognostic population and warrant confirmation in a phase 3 study with the aim of expanding the therapeutic options for these patients.
FUNDING


Debiopharm.",2020,"18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026).","['patients with an oropharyngeal primary tumour site', 'French Head and Neck Radiotherapy Oncology Group (GORTEC) was run at 19 hospitals in France and Switzerland', 'patients with high-risk locally advanced squamous cell carcinoma of the head and neck', 'high-risk locoregionally advanced squamous cell carcinoma of the head and neck', '48 patients were randomly assigned to the Debio 1143 group and 48 to the', 'Between Jan 25, 2016, and April 24, 2017', 'Eligible patients were aged 18-75 years with locoregionally advanced, squamous cell carcinoma of the head and neck (characterised as non-metastatic, measurable stage III, IVa, or IVb [limited to T ≥2, N0-3, and M0] disease), Eastern Cooperative Oncology Group performance status of 0 or 1, a history of heavy tobacco smoking (>10 pack-years) with no previous or current treatment for invasive head and neck cancer, and no previous treatment with inhibitor of apoptosis protein antagonists']","['standard high-dose cisplatin chemoradiotherapy', 'Debio 1143 in combination with standard chemoradiotherapy', 'cisplatin chemoradiotherapy comparator', 'oral placebo', 'oral Debio', 'Debio 1143 and high-dose cisplatin chemoradiotherapy', 'cisplatin and radiotherapy', 'placebo']","['proportion of patients with locoregional control', 'Median duration', 'dysphagia', 'caspase activation and TNF, IFNγ, CD8 T cell-dependent pathways', 'mucositis', 'efficacy and safety', 'anaemia', 'Serious treatment-emergent adverse events', 'adverse events', 'Locoregional control', 'Grade 3 or worse adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0475447', 'cui_str': 'Primary tumor site'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C2983774', 'cui_str': 'AT 406'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco smoking behavior - finding'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0893445', 'cui_str': 'Inhibitor-Of-Apoptosis Protein'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C2983774', 'cui_str': 'AT 406'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",48.0,0.373852,"18 months after chemoradiotherapy was achieved in 26 (54%; 95% CI 39-69) of 48 patients in the Debio 1143 group versus 16 (33%; 20-48) of 48 patients in the placebo group (odds ratio 2·69 [95% CI 1·13-6·42], p=0·026).","[{'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, Nord Franche-Comté de Montbéliard and CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Le Tourneau', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, Paris, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Oncologie-Radiothérapie, Institut Inter-RégionaL de Cancérologie, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Bretagne Sud, Hôpital du Scorff Radiothérapie, Lorient, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Kaminsky', 'Affiliation': ""L'Institut de Cancérologie de Lorraine Alexis Vautrin, Oncologie Médicale, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU Amiens Picardie, Oncologie-Radiothérapie, Amiens, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Radiothérapie, Avignon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': ""Institut du Cancer de Montpellier, Val d'Aurelle, Oncologie-Radiothérapie, Montpellier, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Radiothérapie, Le Havre, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Radiothérapie, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Ramee', 'Affiliation': 'CHD Vendée, Radiothérapie, La Roche Sur Yon, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': ""Institut Claudius Regaud, Oncopole, Unité de Recherche Clinique de l'Institut Claudius Regaud, Toulouse, France.""}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Clatot', 'Affiliation': ""Centre Henri Becquerel, Service Oncologie Médicale rue d'Amiens, Rouen, France.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Institut de Cancérologie de l'Ouest René Gauducheau, Institut de Cancérologie de l'Ouest, Saint-Herblain, France.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Villa', 'Affiliation': 'CHU Grenoble, Radiothérapie, Pôle de Cancérologie, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magne', 'Affiliation': 'Institut de Cancérologie Lucien Neuwirth, Radiothérapie, Saint-Priest en Jarez, France.'}, {'ForeName': 'Olgun', 'Initials': 'O', 'LastName': 'Elicin', 'Affiliation': 'Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Elisabeta', 'Initials': 'E', 'LastName': 'Gherga', 'Affiliation': 'Department of Radiation Oncology, Nord Franche-Comté de Montbéliard and CHRU de Besançon, Besançon, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Cedrick', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Oncologie-Radiothérapie, Institut Inter-RégionaL de Cancérologie, Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bera', 'Affiliation': 'Centre Hospitalier de Bretagne Sud, Hôpital du Scorff Radiothérapie, Lorient, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Calugaru', 'Affiliation': 'Department of Drug Development and Innovation, Institut Curie, Paris, France.'}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': ""L'Institut de Cancérologie de Lorraine Alexis Vautrin, Oncologie Médicale, Vandoeuvre-lès-Nancy, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Chauffert', 'Affiliation': 'CHU Amiens Picardie, Oncologie-Radiothérapie, Amiens, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Zubel', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Zanna', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Silvano', 'Initials': 'S', 'LastName': 'Brienza', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Crompton', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Rouits', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Gollmer', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Szyldergemajn', 'Affiliation': 'Debiopharm International, Lausanne, Switzerland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV, Service de Radio-oncologie, Bâtiment Hospitalier, Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30327-2']
1585,32758672,Beneficial Effects of Role Reversal in Comparison to role-playing on negative cognitions about Other's Judgments for Social Anxiety Disorder.,"BACKGROUND AND OBJECTIVES


Negative beliefs about other's judgments play an important role in the development and maintenance of social anxiety disorder. The present experiment examined the effects of role-playing followed by role reversal compared to role-playing twice on altering these negative cognitions.
METHODS


Thirty-six adult social anxiety patients were randomized into two conditions: a role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal. Before the start of the experiment, patients were asked to report their negative cognitions about the other's judgments. Next, they were asked to rate the believability of these negative cognitions, as well as the probability and cost estimates of negative judgments by the other person, at three time-points: before the first block of role-playing, after the first block of role-playing, and after the second block of the experiment.
RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
LIMITATIONS


The most important limitation of the present study is that there was no control group to assess the effects of role-playing alone. Moreover, the second block of the experiment was repetitive in role-playing, however, it was a new task in role reversal.
CONCLUSIONS


The results support the hypothesis that role reversal is an effective technique that can be used to correct negative cognitions about other's judgments in SAD.",2020,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","['Thirty-six adult social anxiety patients', ""negative cognitions about Other's Judgments for Social Anxiety Disorder""]","['role-playing condition in which 18 participants role-played an anxiety-provoking social situation twice, or a role reversal condition in which 18 participants role-played an anxiety-provoking social situation followed by enacting the same situation using role reversal']",[],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",[],36.0,0.0134432,"RESULTS


Results demonstrated that role-playing followed by role reversal had a stronger effect on the most negative cognitions than role-playing twice.
","[{'ForeName': 'Hanieh', 'Initials': 'H', 'LastName': 'Abeditehrani', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands. Electronic address: H.Abeditehrani@uva.nl.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Dijk', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}, {'ForeName': 'Mohsen Dehghani', 'Initials': 'MD', 'LastName': 'Neyshabouri', 'Affiliation': 'University of Social Welfare and Rehabilitation Sciences, Department of Clinical Psychology, Tehran, Iran.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'University of Amsterdam, Department of Clinical Psychology, Amsterdam, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101599']
1586,32758677,Inspiratory neural drive and dyspnea in interstitial lung disease: Effect of inhaled fentanyl.,"BACKGROUND


Exertional dyspnea in interstitial lung disease (ILD) remains difficult to manage despite advances in disease-targeted therapies. Pulmonary opioid receptors present a potential therapeutic target for nebulized fentanyl to provide dyspnea relief.
METHODS


ILD patients were characterized with reference to healthy volunteers. A randomized, double-blind, placebo-controlled crossover comparison of 100 mcg nebulized fentanyl vs placebo on dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise was performed in 21 ILD patients.
RESULTS


Dyspnea intensity in ILD increased in association with an increase in IND (diaphragm activation) from a high resting value of 16.66 ± 6.52 %-60.04 ± 12.52 % of maximum (r = 0.798, p < 0.001). At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
CONCLUSION


IND rose sharply during constant work rate exercise in association with dyspnea intensity in mild to moderate ILD but was not different after nebulized fentanyl compared with placebo.",2020,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","['ILD patients were characterized with reference to healthy volunteers', 'interstitial lung disease', '21 ILD patients']","['inhaled fentanyl', '100 mcg nebulized fentanyl vs placebo', 'nebulized fentanyl', 'fentanyl vs placebo', 'placebo']","['IND responses', 'IND (diaphragm activation', 'dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise', 'dyspnea intensity ratings', 'Inspiratory neural drive and dyspnea']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",21.0,0.334941,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada; Clinician Investigator Program, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Ibrahim-Masthan', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Moran-Mendoza', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Neder', 'Initials': 'N', 'LastName': 'Ja', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada. Electronic address: odonnell@queensu.ca.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103511']
1587,32767145,Prospective randomized controlled trial on comparison of standard CO 2  pressure pneumoperitoneum insufflator versus AirSeal®.,"BACKGROUND


AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO 2  recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO 2  insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO 2  insufflators in patients undergoing the most frequently performed laparoscopic procedures.
METHODS


One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO 2  insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay.
RESULTS


Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.
CONCLUSION


This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO 2  insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).",2020,"There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.
","['One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair', 'patients undergoing the most frequently performed laparoscopic procedures']","['AirSeal® and standard CO', 'AirSeal®', 'standard CO 2  pressure pneumoperitoneum insufflator versus AirSeal®', 'standard pressure CO 2  insufflator']","['complications, surgical side effects (subcutaneous emphysema', 'surgical outcomes', 'Clavien-Dindo grade complications, surgical side effect and length of hospital stay', 'Shoulder tip pain levels', 'length of hospital stay', 'mean operative time', 'operative time', 'operative time and level of postoperative shoulder tip pain (Visual Analog Scale']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0021639', 'cui_str': 'Insufflator'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0038536', 'cui_str': 'Subcutaneous emphysema'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",198.0,0.12362,"There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay.
","[{'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Luketina', 'Affiliation': 'Department Hand, Plastic, Reconstructive and Burn Surgery, BG Trauma Center Tuebingen, Eberhard Karls University Tuebingen, Schnarrenbergstr. 95, 72076, Tuebingen, Germany. r_luketina@yahoo.de.'}, {'ForeName': 'Theodore L H', 'Initials': 'TLH', 'LastName': 'Luketina', 'Affiliation': 'Department of Anaesthesia & Intensive Care Medicine, Cantonal Hospital of Muensterlingen, Muensterlingen, Switzerland.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Antoniou', 'Affiliation': 'Department of Surgery, School of Medicine, European University Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Köhler', 'Affiliation': 'Department of General and Visceral Surgery, Congregation Hospital (Sisters of Charity), Ordensklinikum Linz, Austria.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Könneker', 'Affiliation': 'Department of Plastic, Aesthetic, Hand and Reconstructive Surgery, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Manzenreiter', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Helwig', 'Initials': 'H', 'LastName': 'Wundsam', 'Affiliation': 'Department of General and Visceral Surgery, Congregation Hospital (Sisters of Charity), Ordensklinikum Linz, Austria.'}, {'ForeName': 'Oliver Owen', 'Initials': 'OO', 'LastName': 'Koch', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Knauer', 'Affiliation': 'Breast Center Ostschweiz, Schuppistrasse 10, 9016, St. Gallen, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Emmanuel', 'Affiliation': 'Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}]",Surgical endoscopy,['10.1007/s00464-020-07846-4']
1588,32767696,Predictors of Older Adult Adherence With Emergency Department Discharge Instructions.,"OBJECTIVE


Older adults discharged from the emergency department (ED) are at high risk for adverse outcomes. Adherence to ED discharge instructions is necessary to reduce those risks. The objective of this study is to determine the individual-level factors associated with adherence with ED discharge instructions among older adult ED outpatients.
METHODS


We performed a secondary analysis of data from the control group of a randomized controlled trial testing a care transitions intervention among older adults (age ≥ 60 years) discharged home from the ED in two states. Taking data from patient surveys and chart reviews, we used multivariable logistic regression to identify patient characteristics associated with adherence to printed discharge instructions. Outcomes were patient-reported medication adherence, provider follow-up visit adherence, and knowledge of ""red flags"" (signs of worsening health requiring further medical attention).
RESULTS


A total 824 patients were potentially eligible, and 699 had data in at least one pillar. A total of 35% adhered to medication instructions, 76% adhered to follow-up instructions, and 35% recalled at least one red flag. In the multivariate analysis, no factors were significantly associated with failure to adhere to medications. Participants with poor health status (adjusted odds ratio [AOR] = 0.55, 95% confidence interval [CI] = 0.31 to 0.98) were less likely to adhere to follow-up instructions. Participants who were older (AORs trended downward as age category increased) or depressed (AOR = 0.39, 95% CI = 0.17 to 0.85) or had one or more functional limitations (AOR = 0.62, 95% CI = 0.41 to 0.94) were less likely to recall red flags.
CONCLUSION


Older adults discharged home from the ED have mixed rates of adherence to discharge instructions. Although it is thought that some subgroups may be higher risk than others, given the opportunity to improve ED-to-home transitions, EDs and health systems should consider providing additional care transition support to all older adults discharged home from the ED.",2020,"Outcomes were patient-reported medication adherence, provider follow-up visit adherence, and knowledge of ""red flags"" (signs of worsening health requiring further medical attention).
","['Older adults discharged from the emergency department (ED', '824 patients were potentially eligible, and 699 had data in at least one pillar', 'older adult ED outpatients', 'older adults (age≥60) discharged home from the ED in two states', 'Older Adult Adherence with Emergency Department Discharge Instructions']",['care transitions intervention'],"['medication adherence, provider follow-up visit adherence, and knowledge of ""red flags"" (signs of worsening health requiring further medical attention']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C5200790', 'cui_str': 'Flags'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",824.0,0.136991,"Outcomes were patient-reported medication adherence, provider follow-up visit adherence, and knowledge of ""red flags"" (signs of worsening health requiring further medical attention).
","[{'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Benjenk', 'Affiliation': 'From the, Department of Health Policy and Management, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Eva H', 'Initials': 'EH', 'LastName': 'DuGoff', 'Affiliation': 'From the, Department of Health Policy and Management, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Gwen C', 'Initials': 'GC', 'LastName': 'Jacobsohn', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Cayenne', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Courtney M C', 'Initials': 'CMC', 'LastName': 'Jones', 'Affiliation': 'the, Department of Emergency Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Caprio', 'Affiliation': 'the, Department of Public Health Sciences, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jeremy T', 'Initials': 'JT', 'LastName': 'Cushman', 'Affiliation': 'the, Department of Emergency Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Green', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Amy J H', 'Initials': 'AJH', 'LastName': 'Kind', 'Affiliation': 'the, Division of Geriatrics and Gerontology, Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lohmeier', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Ranran', 'Initials': 'R', 'LastName': 'Mi', 'Affiliation': 'and the, Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Manish N', 'Initials': 'MN', 'LastName': 'Shah', 'Affiliation': 'the, Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14105']
1589,32763234,Comparison of intermittent versus continuous-infusion vancomycin for treating severe patients in intensive care units.,"PURPOSE


The aim of this study was to compare pharmacokinetic characteristics between intermittent infusion and continuous infusion of vancomycin for critically ill patients admitted to intensive care units.
METHODS


Intermittent therapy was administered for 60minutes and prescribed as a loading dose of 30mg/kg and continued with 15mg/kg q12h. Continuous infusion was prescribed as a loading dose of 30mg/kg followed by 30mg/kg on constant infusion pump. Blood samples from vancomycin intermittent infusion group were collected 1h before third dose, 1h, 8h and 24h after third dose infusion. Blood samples from vancomycin continuous infusion group were collected 1h after loading dose, 12h, 24h, 36h, and 48h after continuous infusion initiation.
RESULTS


Median serum concentration of continuous infusion group at 24-hour was 23.59μg/mL [14.52-28.97], while of intermittent infusion group at 23-hour was 12.30μg/mL [7.27-18.12] and on 25-hour was 17.58μg/mL [12.5-22.5]. Medians AUC 24-48h  were 357.2mg.h/L and 530.2mg.h/L for intermittent infusion and continuous infusion groups, respectively (p=0.559).
CONCLUSION


Vancomycin CI reached steady state earlier, which guaranteed therapeutic levels from the first day and made it possible to manage therapeutic drug monitoring faster.",2020,"AUC 24-48h  were 357.2mg.h/L and 530.2mg.h/L for II and CI groups, respectively (p=0.559).
","['critically ill patients admitted to intensive care units', 'severe patients in intensive care units']","['vancomycin CI', 'vancomycin', 'intermittent versus continuous-infusion vancomycin', 'intermittent infusion (II) and continuous infusion (CI) of vancomycin', 'Vancomycin CI']","['pharmacokinetic characteristics', 'Median serum concentration']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0813945,"AUC 24-48h  were 357.2mg.h/L and 530.2mg.h/L for II and CI groups, respectively (p=0.559).
","[{'ForeName': 'Carolina Hikari', 'Initials': 'CH', 'LastName': 'Yamada', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil.'}, {'ForeName': 'João Paulo', 'Initials': 'JP', 'LastName': 'Telles', 'Affiliation': 'AC Camargo Cancer Center, São Paulo, SP, Brazil; Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil.'}, {'ForeName': 'Dayana Dos Santos', 'Initials': 'DDS', 'LastName': 'Oliveira', 'Affiliation': 'Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Cieslinski', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil.'}, {'ForeName': 'Victoria Stadler Tasca', 'Initials': 'VST', 'LastName': 'Ribeiro', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Gasparetto', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil.'}, {'ForeName': 'Felipe Francisco', 'Initials': 'FF', 'LastName': 'Tuon', 'Affiliation': 'Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Curitiba, Paraná, PR, Brazil; Hospital Universitário Cajuru, Curitiba, Paraná, PR, Brazil; Pontifícia Universidade Católica do Paraná, Faculdade de Medicina, Laboratório de Doenças Infeccionas Emergentes, Curitiba, PR, Brazil. Electronic address: felipe.tuon@pucpr.br.'}]",The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases,['10.1016/j.bjid.2020.07.001']
1590,32763585,Plasma MCP-1 levels in bipolar depression during cyclooxygenase-2 inhibitor combination treatment.,"BACKGROUND


Neuroinflammation plays a role in the pathophysiology of Bipolar Disorder Depression (BDD) and altered levels of inflammatory mediators, such as monocyte chemoattractant protein-1 (MCP-1, aka CCL2) have been reported. This study reports specifically on MCP-1 levels, as a potential marker of BDD and/or treatment response in patients receiving combination treatment with the cyclooxygenase-2 inhibitor, celecoxib (CBX).
METHODS


In this randomized, 10-week, double-blind, two-arm, placebo-controlled study, 47 patients with treatment resistant BDD received either escitalopram (ESC) + CBX, or ESC + placebo (PBO). Plasma MCP-1 levels were measured at 3 time points in the BDD subjects, and in a healthy control (HC) group. Depression severity was quantified using the Hamilton Depression Scale (HAMD-17).
RESULTS


The CBX group had significantly lower HAMD-17 scores vs. PBO at week 4 (P = 0.026) and week 8 (P = 0.002). MCP-1 levels were not significantly different in BDD vs. HC subjects at baseline (P = 0.588), nor in CBX vs. PBO groups at week 8 (P = 0.929). Week 8 HAMD-17 scores and MCP-1 levels were significantly negatively correlated in treatment non-responders to CBX or PBO (P = 0.050). Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014). MCP-1 was positively correlated with pro-inflammatory analytes in the PBO group and with anti-inflammatory analytes in the CBX group.
CONCLUSIONS


Combination treatment reduced treatment resistance and augmented antidepressant response. Baseline plasma MCP-1 levels were not altered in BDD patients. Since non-responders had lower levels of MCP-1, elevated MCP-1 may indicate a better response to CBX + SSRI treatment.",2020,Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014).,"['47 patients with treatment resistant BDD received either', 'patients receiving combination treatment with the']","['cyclooxygenase-2 inhibitor combination treatment', 'cyclooxygenase-2 inhibitor, celecoxib (CBX', 'CBX', 'escitalopram (ESC)\xa0+\xa0CBX, or ESC\xa0+\xa0placebo (PBO', 'placebo']","['Depression severity', 'Hamilton Depression Scale (HAMD-17', 'treatment resistance and augmented antidepressant response', 'MCP-1 levels', 'HAMD-17 scores and MCP-1 levels', 'MCP-1', 'Baseline plasma MCP-1 levels', 'Plasma MCP-1 levels', 'HAMD-17 scores vs. PBO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",47.0,0.0285352,Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edberg', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Walborn', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sinacore', 'Affiliation': 'Department of Public Health Sciences, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Halaris', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA. Electronic address: ahalaris@lumc.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.010']
1591,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1592,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1593,32763878,Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial.,"BACKGROUND


Drink Less is a behavior change app that aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11 am, asking users to ""Please complete your mood and drinking diaries."" Previous analysis of Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour. To exploit a potential increase of vulnerability of excess drinking and opportunity to engage with the app in the evenings, we changed the delivery time from 11 am to 8 pm. We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user's perceived usefulness of the app.
OBJECTIVE


The primary objective is to assess whether sending a notification at 8 pm increases behavioral engagement (opening the app) in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth, and frequency of engagement with Drink Less over the first 30 days after download.
METHODS


This is a protocol for a micro-randomized trial with two additional parallel arms. Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol. In the micro-randomized trial, participants will be randomized daily at 8 pm to receive no notification, a notification with text from the new message bank, or the standard message. The primary outcome is the time-varying, binary outcome of ""Did the user open the app in the hour from 8 pm to 9 pm?"". The primary analysis will estimate the marginal relative risk for the notifications using an estimator developed for micro-randomized trials with binary outcomes. Participants randomized to the parallel arms will receive no notifications (Secondary Arm A), or the standard notification delivered daily at 11 am (Secondary Arm B) over 30 days, allowing the comparison of overall engagement between different notification delivery strategies.
RESULTS


Approval was granted by the University College of London's Departmental Research Ethics Committee (CEHP/2016/556) on October 11, 2019, and The London School of Hygiene and Tropical Medicine Interventions Research Ethics Committee (17929) on November 27, 2019. Recruitment began on January 2, 2020, and is ongoing.
CONCLUSIONS


Understanding how push notifications may impact engagement with a behavior change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalizable to other apps that target a variety of behavior changes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18690.",2020,"We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user's perceived usefulness of the app.
",['Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol'],"['asking users to ""Please complete your mood and drinking diaries']","['overall duration, depth, and frequency of engagement with Drink Less', 'new bank of messages with the standard message and effect moderation over time', 'time-varying, binary outcome of ""Did the user open the app in the hour from 8 pm to 9 pm']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2732658', 'cui_str': 'Alcohol use disorders identification test score'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439227', 'cui_str': 'hour'}]",,0.161916,"We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user's perceived usefulness of the app.
","[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Bell', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Garnett', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Tianchen', 'Initials': 'T', 'LastName': 'Qian', 'Affiliation': 'Department of Statistics, Harvard University, Cambridge, MA, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Perski', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Henry W W', 'Initials': 'HWW', 'LastName': 'Potts', 'Affiliation': 'Institute of Health Informatics, University College London, London, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",JMIR research protocols,['10.2196/18690']
1594,32763882,A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing.
OBJECTIVE


The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes.
METHODS


A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships.
RESULTS


Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes.
CONCLUSIONS


The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16198.",2020,"The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings.
","['4 public and 2 private health facilities in coastal Kenya before and after intervention delivery', '1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period', 'Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes', 'young adults aged 18 to 39 years', '1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment', 'young adults presenting for care, employs HIV partner notification services', 'Young Adults and Reduce HIV Transmission in Kenya', 'Young adults']",['HIV-1 RNA Testing Intervention'],[],"[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0079990', 'cui_str': 'Partner Notification'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]","[{'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],1500.0,0.117879,"The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings.
","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Graham', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Agutu', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van der Elst', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Amin S', 'Initials': 'AS', 'LastName': 'Hassan', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Evanson', 'Initials': 'E', 'LastName': 'Gichuru', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Mugo', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Babigumira', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Goodreau', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Deven T', 'Initials': 'DT', 'LastName': 'Hamilton', 'Affiliation': 'Center for Studies in Demography and Ecology, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Thumbi', 'Initials': 'T', 'LastName': ""Ndung'u"", 'Affiliation': 'Africa Health Research Institute, Durban, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sirengo', 'Affiliation': 'Department of Health Infrastructure Management, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Wairimu', 'Initials': 'W', 'LastName': 'Chege', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, United States.'}, {'ForeName': 'Eduard J', 'Initials': 'EJ', 'LastName': 'Sanders', 'Affiliation': 'Kenya Medical Research Institute - Wellcome Trust Research Programme, Kilifi, Kenya.'}]",JMIR research protocols,['10.2196/16198']
1595,32791321,Guilt and expressive writing for reducing alcohol use in college students: Study protocol for a randomized control trial.,"The current proposed study aims to evaluate expressive writing as a novel intervention for reducing problematic drinking among college students. College students are at increased risk for alcohol misuse compared to other adults, and the development of efficacious intervention approaches is an urgent priority. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to refinements of this paradigm, which require large-scale assessment and intricate programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy. We propose a theoretically-based approach that incorporates expression of the self-conscious emotion of guilt and the written analogue of change talk as proposed mechanisms of intervention efficacy. We will also examine individual differences in guilt-proneness as a moderator of intervention efficacy. Heavy drinking college students (N = 600) will be randomly assigned to one of six expressive writing conditions based on a 2 (alcohol vs. distress) × 2 (guilt vs. no guilt) + 1 (control writing) + 1 (personalized feedback) design. Participation in the study involves completion of a screening assessment, a baseline assessment, three in-lab intervention sessions, post-intervention assessments, and follow-up assessments one-month, three-months, six months, and twelve-months later. If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.",2020,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","['College students', 'Heavy drinking college students (N\u202f=\u202f600', 'college students']","['\u202f1 (control writing', 'Guilt and expressive writing', 'six expressive writing conditions based on a 2 (alcohol vs. distress']",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",[],600.0,0.018722,"If effective, this novel intervention approach would not require any pre-assessment or programming of personalized feedback, and would serve as a more easily disseminable alternative to existing approaches.","[{'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Jordanna Lembo', 'Initials': 'JL', 'LastName': 'Riggs', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America.'}, {'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, NJ, United States of America.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Angosta', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America. Electronic address: jangosta@central.uh.edu.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Cunningham-Erdogdu', 'Affiliation': 'Department of Psychology, University of Houston, Houston, TX, United States of America; Department of Psychology, University of Texas at Austin, Austin, TX, United States of America.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, University of Texas, MD Anderson Cancer Center, Houston, TX, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106107']
1596,32764077,θ-γ Cross-Frequency Transcranial Alternating Current Stimulation over the Trough Impairs Cognitive Control.,"Cognitive control is a mental process, which underlies adaptive goal-directed decisions. Previous studies have linked cognitive control to electrophysiological fluctuations in the θ band and θ-γ cross-frequency coupling (CFC) arising from the cingulate and frontal cortices. However, to date, the behavioral consequences of different forms of θ-γ CFC remain elusive. Here, we studied the behavioral effects of the θ-γ CFC via transcranial alternating current stimulation (tACS) designed to stimulate the frontal and cingulate cortices in humans. Using a double-blind, randomized, repeated measures study design, 24 healthy participants were subjected to three active and one control CFC-tACS conditions. In the active conditions, 80-Hz γ tACS was coupled to 4-Hz θ tACS. Specifically, in two of the active conditions, short γ bursts were coupled to the delivered θ cycle to coincide with either its peaks or troughs. In the third active condition, the phase of a θ cycle modulated the amplitude of the γ oscillation. In the fourth, control protocol, 80-Hz tACS was continuously superimposed over the 4-Hz tACS, therefore lacking any phase specificity in the CFC. During the 20 min of stimulation, the participants performed a Go/NoGo monetary reward-based and punishment-based instrumental learning task. A Bayesian hierarchical logistic regression analysis revealed that relative to the control, the peak-coupled tACS had no effects on the behavioral performance, whereas the trough-coupled tACS and, to a lesser extent, amplitude-modulated tACS reduced performance in conflicting trials. Our results suggest that cognitive control depends on the phase specificity of the θ-γ CFC.",2020,"A Bayesian hierarchical logistic regression analysis revealed that relative to the control, the peak-coupled tACS had no effects on the behavioral performance, whereas the trough-coupled tACS and, to a lesser extent, amplitude-modulated tACS reduced performance in conflicting trials.","['24 healthy participants were subjected to three active and one control CFC-tACS conditions', 'humans']","['theta-gamma CFC via transcranial alternating current stimulation (tACS', 'gamma tACS', 'Go/NoGo monetary reward- and punishment-based instrumental learning task']",['behavioral performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009651', 'cui_str': 'Operant conditioning'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",24.0,0.0618721,"A Bayesian hierarchical logistic regression analysis revealed that relative to the control, the peak-coupled tACS had no effects on the behavioral performance, whereas the trough-coupled tACS and, to a lesser extent, amplitude-modulated tACS reduced performance in conflicting trials.","[{'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Turi', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany zsoltturi@gmail.com matthias.mittner@uit.no.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Mittner', 'Affiliation': 'Department of Psychology, UiT The Arctic University of Norway, 9037 zsoltturi@gmail.com matthias.mittner@uit.no.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lehr', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Bürger', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antal', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center Göttingen, Göttingen 37073, Germany.'}]",eNeuro,['10.1523/ENEURO.0126-20.2020']
1597,32770443,Intervention Delivery Matters: What Mothers at High Risk for Type 2 Diabetes Want in a Diabetes Prevention Program-Results from a Comparative Effectiveness Trial.,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program. Challenges with flexible intervention delivery, accessibility, the traditional group-based format, and Coronavirus Disease 2019 (COVID-19) exposure risk can be mitigated by participant preferences for one-on-one, virtual/online intervention delivery.Trial Registration: ClinicalTrials.gov identifier, NCT01823367.",2020,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program.",['Intervention Delivery Matters'],[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],[],,0.0293589,"Participants in the ENCOURAGE Healthy Families Study, a family-focused, modified Diabetes Prevention Program, reported challenges to and preferences for engaging in a diabetes prevention program.","[{'ForeName': 'Kelly N B', 'Initials': 'KNB', 'LastName': 'Palmer', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA. kpalmer1@arizona.edu.'}, {'ForeName': 'Valene E', 'Initials': 'VE', 'LastName': 'Garr Barry', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Marrero', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'McKinney', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, USA.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Graves', 'Affiliation': 'YMCA of Greater Indianapolis, Indianapolis, USA.'}, {'ForeName': 'Chelsy K', 'Initials': 'CK', 'LastName': 'Winters', 'Affiliation': 'YMCA of Greater Indianapolis, Indianapolis, USA.'}, {'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00891-1']
1598,32768993,The relationship between insomnia and the intensity of drinking in treatment-seeking individuals with alcohol dependence.,"BACKGROUND


Although insomnia is highly prevalent in alcohol use disorders(AUD), its associations with the severity of alcohol use, pre-existing psychiatric comorbidities and psychosocial problems are understudied. The present study evaluates the interplay between these factors using a structural equation model (SEM).
METHODS


We assessed baseline cross-sectional data on patients with AUD (N = 123) recruited to a placebo-controlled medication trial. Severity of alcohol use was measured by the Brief Michigan Alcoholism Screening Test (B-MAST). Insomnia Severity Index was used to assess insomnia symptoms. The Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively. We used logistic regression to evaluate the association between insomnia and severity of alcohol use while controlling for covariates. We constructed a SEM with observed variables to delineate the effect of psychiatric symptoms, psychosocial factors and current alcohol use on the pathway between alcohol use severity and insomnia.
RESULTS


The sample was predominately male(83.9 %), Black(54.6 %) and employed(60.0 %). About 45 % of the participants reported moderate-severe insomnia.The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] = 1.17(0.99-1.47). SEM findings demonstrated that B-MAST and insomnia were linked to psychiatric symptoms (95 % Asymptotic-Confidence Interval (ACI): 0.015-0.159, p < 0.05) but not to psychosocial problems or current alcohol use.
CONCLUSION


Among treatment-seeking patients with AUD, psychiatric burden mediated the relationship between severity of alcohol use and insomnia. Clinicians should screen for underlying psychiatric disorders among treatment-seeking patients with AUD complaining of insomnia.",2020,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","['patients with AUD (N = 123) recruited to a placebo-controlled medication trial', 'treatment-seeking patients with AUD', 'treatment-seeking patients with AUD complaining of insomnia', 'treatment-seeking individuals with alcohol dependence']",[],"['Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively', 'Insomnia Severity Index', 'insomnia symptoms', 'psychiatric symptoms', 'moderate-severe insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439022', 'cui_str': 'Complaining of insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",123.0,0.022062,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","[{'ForeName': 'Ninad S', 'Initials': 'NS', 'LastName': 'Chaudhary', 'Affiliation': 'University of Alabama at Birmingham School of Public Health, 1665 University Blvd, Birmingham, AL, 35211, USA. Electronic address: ninadsc@uab.edu.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wong', 'Affiliation': 'Idaho State University, 921 S 8th Ave, Stop 8112, Pocatello, ID, 83209, USA.'}, {'ForeName': 'Bhanu Prakash', 'Initials': 'BP', 'LastName': 'Kolla', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, 2nd ST SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Subhajit', 'Initials': 'S', 'LastName': 'Chakravorty', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA. Electronic address: Subhajit.Chakravorty@uphs.upenn.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108189']
1599,32769027,Does CPAP treat depressive symptoms in individuals with OSA? An analysis of two 12-week randomized sham CPAP-controlled trials.,"BACKGROUND


Depression is common in patients with obstructive sleep apnea (OSA). Whether treating OSA with continuous positive airway pressure (CPAP) improves depressive symptoms remains inconclusive. We examined the impact of CPAP on depressive symptoms in OSA patients compared to sham CPAP.
METHODS


A sub-analysis of two previous randomized sham-controlled trials was conducted. 126 male OSA patients (age = 51 ± 11 years; BMI = 32.0 ± 5.1 kg/m 2 ; apnea hypopnea index = 42.4 ± 22.6 events/hour) were randomised either to therapeutic CPAP (n = 65) or sham CPAP (n = 61). Depressive symptoms were measured using the Depression, Anxiety and Stress Scale (DASS). The main outcome was the change in the DASS depression score (DASSD) after three months between the therapeutic and sham CPAP arms.
RESULTS


The change in DASSD at three months did not differ between therapeutic and sham CPAP (mean difference: 0.5, 95% CI -3.6 to 4.6, p = 0.80). There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9). In a secondary analysis of patients with baseline depression, adherent therapeutic CPAP use was associated with a greater reduction in DASSD scores compared to non-adherers (-10.0, 95% CI -18.3 to -1.8, p = 0.019).
CONCLUSIONS


Overall, three months of CPAP did not significantly improve depression scores in OSA patients. Adherent use of therapeutic CPAP in patients with baseline depressive symptoms was associated with a reduction in symptom score. Future trials involving OSA patients with higher depressive symptoms will enable us to understand the complex interaction between OSA and depression.",2020,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","['OSA patients with higher depressive symptoms', '126 male OSA patients (age\xa0=\xa051\xa0±\xa011 years; BMI\xa0=\xa032.0\xa0±\xa05.1\xa0kg/m 2 ; apnea hypopnea index\xa0=\xa042.4\xa0±\xa022.6 events/hour', 'patients with baseline depressive symptoms', 'individuals with OSA', 'OSA patients', 'patients with obstructive sleep apnea (OSA']","['OSA with continuous positive airway pressure (CPAP', 'sham CPAP', 'CPAP', 'therapeutic CPAP']","['depression scores', 'Depression, Anxiety and Stress Scale (DASS', 'change in DASSD', 'Depressive symptoms', 'DASSD scores', 'DASS depression score (DASSD', 'depressive symptoms']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",126.0,0.313538,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Department of Sleep Medicine, Surgery and Science, Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Melehan', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California, USA.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; School of Psychology, Brain and Mind Centre and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: camilla.hoyos@sydney.edu.au.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.021']
1600,32769065,The effects of foot reflexology on agitation and extubation time in male patients following coronary artery bypass surgery: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


This study examined the effects of foot reflexology on agitation and extubation time of male patients following coronary artery bypass graft surgery.
MATERIALS AND METHODS


In this randomized three-arm controlled clinical trial, participants (n = 120) were randomly assigned to the intervention, placebo, or control groups. The intervention group received foot reflexology massage for 15 min. Agitation was assessed using the Richmond Agitation- Sedation Scale before the intervention (Time 1) and immediately (Time 2) and 10 min after the intervention (Time 3). Extubation time was measured as the time from gaining full consciousness to endotracheal extubation.
RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001). Also, extubation time was significantly shorter in the intervention group (p < 0.01).
CONCLUSION


Foot reflexology may be introduced as a nursing intervention to facilitate the weaning process in the cardiac ICUs.",2020,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","['male patients following coronary artery bypass surgery', 'male patients following coronary artery bypass graft surgery', 'participants (n\xa0=\xa0120']","['foot reflexology', 'foot reflexology massage', 'placebo']","['agitation and extubation time', 'Extubation time', 'extubation time', 'Richmond Agitation- Sedation Scale', 'Agitation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",120.0,0.0559303,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Allahbakhhsian', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholizadeh', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, Australia. Electronic address: Leila.gholizadeh@uts.edu.au.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Allahbakhshian', 'Affiliation': 'Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Faculty of Public Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Abbaszadeh', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: abbaszadeh_yaser@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101201']
1601,32780166,"Combination therapy of vitamin C and thiamine for septic shock: a multi-centre, double-blinded randomized, controlled study.","PURPOSE


To evaluate the effects of early combination therapy with intravenous vitamin C and thiamine on recovery from organ failure in patients with septic shock.
METHODS


The ascorbic acid and thiamine effect in septic shock (ATESS) trial was a multi-centre, double-blind, randomized, controlled trial conducted in four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020. Patients were randomly assigned in a 1:1 ratio to either the treatment group [intravenous vitamin C (50 mg/kg, maximum single dose 3 g) and thiamine (200 mg) administration every 12 h for a total of 48 h] or the placebo group (identical volume of 0.9% saline with the same protocol). The primary outcome was Δ Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment-SOFA score after 72 h). Eighteen secondary outcomes were predefined, including shock reversal and 28-day mortality.
RESULTS


A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the placebo group. There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96]. Predefined secondary outcomes were also not significantly different between the groups.
CONCLUSION


In this study, vitamin C and thiamine administration in the early phase of septic shock did not improve organ function compared with placebo, despite improvements in vitamin C and thiamine levels.",2020,"There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96].","['septic shock', 'patients with septic shock', 'four academic emergency departments, enrolling adult patients with septic shock from December 2018 through January 2020', 'A total of 111 patients were enrolled, of which 53 were assigned to the treatment group and 58 were assigned to the']","['ascorbic acid and thiamine', 'thiamine', 'vitamin C and thiamine', 'intravenous vitamin C', 'placebo']","['ΔSOFA scores', 'Sequential Organ Failure Assessment (SOFA) score (SOFA score at enrolment-SOFA score', 'organ function', 'vitamin C and thiamine levels', 'shock reversal and 28-day mortality']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",111.0,0.826426,"There was no significant difference in ΔSOFA scores between the treatment group and the placebo group [3, interquartile range (IQR) - 1 to 5 vs. 3, IQR 0-4, respectively, p = 0.96].","[{'ForeName': 'Sung Yeon', 'Initials': 'SY', 'LastName': 'Hwang', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Seung Mok', 'Initials': 'SM', 'LastName': 'Ryoo', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea.'}, {'ForeName': 'Jong Eun', 'Initials': 'JE', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'You Hwan', 'Initials': 'YH', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Songnam, Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Jang', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Songnam, Korea.'}, {'ForeName': 'Gil Joon', 'Initials': 'GJ', 'LastName': 'Suh', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Taegyun', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Youn-Jung', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea.'}, {'ForeName': 'Seonwoo', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Centre, Samsung Medical Centre, Seoul, Korea.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Cho', 'Affiliation': 'Statistics and Data Centre, Samsung Medical Centre, Seoul, Korea.'}, {'ForeName': 'Ik Joon', 'Initials': 'IJ', 'LastName': 'Jo', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea.'}, {'ForeName': 'Sung Phil', 'Initials': 'SP', 'LastName': 'Chung', 'Affiliation': 'Department of Emergency Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sung-Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Emergency Medicine, Guro Hospital, Korea University Medical Centre, Seoul, Korea.'}, {'ForeName': 'Tae Gun', 'Initials': 'TG', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Samsung Medical Centre, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Korea. taegunshin@skku.edu.'}, {'ForeName': 'Won Young', 'Initials': 'WY', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Asan Medical Centre, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 138-736, Korea. wonpia73@naver.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06191-3']
1602,32777289,"Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: Results of a real-world study from India.","BACKGROUND


The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD.
PATIENTS AND METHODS


In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV 1 ) at week 24. Pre and post-dose (30 min) FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety were also evaluated. A post-hoc analysis was conducted to evaluate the efficacy of the triple drug combination among smoker and non-smoker COPD patients.
RESULTS


Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV 1  (% predicted) 39 ± 16%], 253 completed the study. Mean change in pre-dose FEV 1  from baseline to week 24 increased significantly after administering the triple drug combination [580 ± 600 mL, 95% CI (510, 650 mL), p < 0.0001]. The increase in the pre-dose FEV 1  was significant at all time points (p < 0.0001). Similar improvements were seen in pre-dose FVC, post-dose FEV 1  and post-dose FVC across all time points. CAT scores and the proportion of patients with improved mMRC score improved at all visits. The post-hoc analysis showed that TFC significantly increased pre-dose FEV 1  both among smokers [mean change 200 ± 430 mL, 95% CI (130, 270 mL), p < 0.0001] as well as non-smokers [990 ± 470 mL, 95% CI (900, 1070 mL), p < 0.0001] at week 24. This difference was significant from week 12 onwards. Mean change in pre and post-dose FEV 1  and FVC was significant across all visits between the two groups. At week 24, CAT score reduced significantly from baseline (overall: -6.6 ± 6.07; smokers: -5.17 + 6.96; non-smokers: 8.06 ± 4.44; all p < 0.0001). The mean difference between the two groups was 2.88 (p < 0.0001) at week 24. TFC was well tolerated.
CONCLUSION


In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.",2020,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"['COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations', 'patients with COPD', 'smoker and non-smoker COPD patients', 'COPD patients requiring triple therapy as judged by their physician, were enrolled', '297 patients enrolled [mean age 61±10 years; 84.8% males; 55.2% smokers and post-dose']","['LABA/LAMA/ICS', 'TFC', 'Tiotropium/Formoterol/Ciclesonide (TFC']","['CAT score', 'tolerated', 'mMRC score', 'FEV 1 , Forced Vital capacity (FVC), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) score and safety', 'lung function, symptoms and quality of life', 'mean change from baseline in pre-dose Forced Expiratory Volume', 'CAT scores']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}]","[{'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0907850', 'cui_str': 'ciclesonide'}]","[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",297.0,0.141329,The increase in the pre-dose FEV 1  was significant at all time points (p< 0.0001).,"[{'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Salvi', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'Ashish Kumar', 'Initials': 'AK', 'LastName': 'Deb', 'Affiliation': 'Sudbhavana Hospital, Varanasi, India.'}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Om Surgical Center & Maternity Home, Varanasi, India.'}, {'ForeName': 'Venkateswara Reddy', 'Initials': 'VR', 'LastName': 'Tummuru', 'Affiliation': 'Eesha Multispeciality Hospital, Hyderabad, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kodgule', 'Affiliation': 'Chest Research Foundation, Pune, India.'}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Hemalatha', 'Affiliation': 'Sree Narayana Institute of Medical Sciences, Ernakulam, India.'}, {'ForeName': 'Anil Kumar', 'Initials': 'AK', 'LastName': 'Awasthi', 'Affiliation': 'Ajantha Hospitals & IVF Centre Pvt. Ltd., Lucknow, India.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Suraj', 'Affiliation': 'Institute of Chest Diseases, Kozhikode, India.'}, {'ForeName': 'Vinod Kumar', 'Initials': 'VK', 'LastName': 'Pavitran', 'Affiliation': 'KVM Multispeciality Hospital, Chirtihala, India.'}, {'ForeName': 'Shashi Prakash', 'Initials': 'SP', 'LastName': 'Mourya', 'Affiliation': 'Lal Hospital & Heart Centre, Lucknow, India.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'Madonna Hospital and Research Centre, Ernakulam, India.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}, {'ForeName': 'Sushmeeta', 'Initials': 'S', 'LastName': 'Chhowala', 'Affiliation': 'Cipla Ltd, Mumbai, India. Electronic address: sushmeeta@cipla.com.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Gogtay', 'Affiliation': 'Cipla Ltd, Mumbai, India.'}]",Pulmonary pharmacology & therapeutics,['10.1016/j.pupt.2020.101932']
1603,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
1604,32601378,COVID-19 among fit patients with CLL treated with venetoclax-based combinations.,,2020,,['patients with CLL treated with venetoclax-based combinations'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],[],,0.0235184,,"[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Fürstenau', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany. moritz.fuerstenau@uk-koeln.de.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'De Silva', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'von Tresckow', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Simon', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Hohloch', 'Affiliation': 'Department of Internal Medicine, Hematology and Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Droogendijk', 'Affiliation': 'Division of Hematology and Oncology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Division of Hematology and Oncology, Amphia Ziekenhuis Breda, Breda, The Netherlands.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'van der Spek', 'Affiliation': 'Department of Internal Medicine, Ziekenhuis Rijnstate, Arnhem, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Illmer', 'Affiliation': 'BAG Freiberg-Richter, Jacobasch, Wolf, Illmer, Dresden, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Schöttker', 'Affiliation': 'Hämatologisch-onkologische Schwerpunktpraxis Würzburg, Würzburg, Germany.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens M', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, German CLL Study Group, Munich Clinic Schwabing, Munich, Germany.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Carsten U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gregor', 'Affiliation': 'Division of Hematology, Cantonal Hospital of Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Arnon P', 'Initials': 'AP', 'LastName': 'Kater', 'Affiliation': 'Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German CLL Study Group, University Hospital Cologne, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-020-0941-7']
1605,32789625,"Awareness, Willingness, and Perceived Efficacy of Pre-exposure Prophylaxis among Adolescent Sexual Minority Males.","Despite the approval of PrEP for adolescents by the FDA in 2018, little is known about the awareness and attitudes about PrEP use among adolescent sexual minority males, who are at the greatest risk for HIV. We analyzed baseline data from the MyPEEPS Mobile study, a multi-site randomized controlled trial evaluating the effectiveness of a mobile behavioral HIV prevention intervention. A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV. On the other hand, only about one third (34.6%) of participants indicated that taking a daily HIV pill would be ""very"" or ""completely"" effective in preventing HIV when having sex without a condom. These findings suggest that high awareness and willingness to use PrEP across various adolescent subgroups present opportunities for increased PrEP advocacy among this young age group.",2020,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","['adolescent sexual minority males', 'Adolescent Sexual Minority Males']",['mobile behavioral HIV prevention intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544438,"A substantial proportion (68.2%) of study participants (ages 13-18) had previously heard about PrEP, and an overwhelming majority (90.8%) reported willingness to take PrEP, to prevent HIV.","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Gordián-Arroyo', 'Affiliation': 'Columbia University, Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Department of Pediatrics, Northwestern's Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen-Lorde Community Health Center, New York, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Keck School of Medicine of the University of Southern California/Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Health Sciences University, Department of Medicine, Brooklyn, NY, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Schrimshaw', 'Affiliation': 'University of Central Florida, College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University, School of Nursing, New York, NY, USA. rb897@columbia.edu.'}]",Journal of urban health : bulletin of the New York Academy of Medicine,['10.1007/s11524-020-00447-5']
1606,32785689,Markers of Iron Flux during Testosterone-Mediated Erythropoiesis in Older Men with Unexplained or Iron-Deficiency Anemia.,"CONTEXT


Testosterone treatment of hypogonadal men improves their hemoglobin, but the mechanism is not understood.
OBJECTIVE


To investigate possible mechanisms by which testosterone stimulates erythropoiesis in hypogonadal older men with unexplained or iron-deficiency anemia.
DESIGN


The Anemia Trial of The Testosterone Trials, a placebo-controlled study in older, hypogonadal men.
SETTING


Twelve academic medical centers.
PARTICIPANTS


A total of 95 hypogonadal men (testosterone < 275 ng/mL) ≥65 years with anemia (hemoglobin < 12.7 g/dL). They were classified as having unexplained (n = 58) or iron deficiency anemia (n = 37).
INTERVENTION


Testosterone or placebo gel for 1 year.
MAIN OUTCOME MEASURES


Markers of iron metabolism during the first 3 months of treatment.
RESULTS


Testosterone replacement significantly (P < 0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% confidence interval, 0.31-0.85). Testosterone replacement tended to increase hemoglobin in the 37 men who had iron deficiency (0.38 g/dL; -0.19, 0.95), but the response was more variable and not statistically significant (P = 0.19). In men with unexplained anemia, testosterone replacement suppressed hepcidin (-8.2 ng/mL; -13.7, -2.7; P = 0.004) and ferritin (-19.6 µg/L; -32.8, -6.3; P = 0.004), but in men with iron deficiency, testosterone replacement did not. The decrease in hepcidin was moderately correlated with the increase in hemoglobin in the men with unexplained anemia (correlation coefficient -0.35, P = 0.01) but not in those with iron deficiency anemia (correlation coefficient -0.07, P = 0.73).
CONCLUSIONS


Testosterone replacement of older hypogonadal men with unexplained anemia stimulates erythropoiesis associated with increased iron mobilization. This effect appears to be attenuated by iron deficiency.",2020,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","['older, hypogonadal men', 'older hypogonadal men with unexplained anemia stimulates erythropoiesis', 'They were classified as having unexplained (58) or iron deficiency anemia (37', 'hypogonadal older men with unexplained or iron-deficiency anemia', 'Older Men with Unexplained or Iron-Deficiency Anemia', 'hypogonadal men', 'Twelve academic medical centers', '95 hypogonadal men (testosterone <275 ng/mL) ≥65 years with anemia (hemoglobin <12.7 g/dL']","['Testosterone-Mediated Erythropoiesis', 'testosterone', 'Testosterone replacement', 'Testosterone or placebo gel', 'placebo']","['hemoglobin', 'Markers of iron metabolism', 'unexplained anemia', 'hepcidin']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}]",95.0,0.520846,"RESULTS


Testosterone replacement significantly (p<0.001) increased hemoglobin in the 58 men who had unexplained anemia (adjusted mean difference 0.58 g/dL; 95% CI 0.31-0.85).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Artz', 'Affiliation': 'City of Hope, Department of Hematology and Hematopoietic Cell Transplantation, Duarte, California.'}, {'ForeName': 'Alisa J', 'Initials': 'AJ', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke University Medical Center, Center for the Study of Aging, Durham, North Carolina.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa521']
1607,32793846,Interleukin-6 May Not Affect Bone Resorption Marker CTX or Bone Formation Marker P1NP in Humans.,"Context


Interleukin 6 (IL-6) contributes to bone remodeling in preclinical studies. Clinical trials investigating the role of IL-6 in bone remodeling are limited.
Objective


To investigate if IL-6 regulates bone remodeling in humans.
Design


Plasma concentrations of the bone resorption marker carboxy-terminal type I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP) were measured during a mixed-meal tolerance test (MMTT) in 3 placebo-controlled human studies.
Participants


Five healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3.
Interventions


Study 1 was a single-blinded crossover study consisting of a 1-h infusion of saline (placebo) or the IL-6 receptor antibody tocilizumab followed by an exercise bout. Study 2 was a randomized, double-blinded 12-week exercise training intervention study. Participants received infusions of saline or tocilizumab. Study 3 was a randomized, double-blinded, crossover study consisting of 30 min infusion of saline or IL-6.
Main outcomes measures


Effect of IL-6 on CTX levels.
Results


CTX was significantly ( P  < 0.01) decreased during MMTTs in all 3 studies. Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2). Exogenous IL-6 had no effect on CTX or P1NP plasma concentrations (study 3).
Conclusions


IL-6 may not regulate bone remodeling in humans.",2020,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"['Participants\n\n\nFive healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3', 'humans']","['saline or tocilizumab', 'I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP', 'saline (placebo', 'tocilizumab', 'IL-6', 'IL-6 receptor antibody tocilizumab']","['CTX or P1NP plasma concentrations', 'CTX levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5.0,0.47895,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"[{'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Lyngbæk', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Chirstensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Søderlund', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa093']
1608,32791048,"Sorafenib maintenance in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised phase 3 trial.","BACKGROUND


Findings of retrospective studies suggest that sorafenib maintenance post-transplantation might reduce relapse in patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. We investigated the efficacy and tolerability of sorafenib maintenance post-transplantation in this population.
METHODS


We did an open-label, randomised phase 3 trial at seven hospitals in China. Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation. Patients were randomly assigned (1:1) to sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control) at 30-60 days post-transplantation. Randomisation was done with permuted blocks (block size four) and implemented through an interactive web-based randomisation system. The primary endpoint was the 1-year cumulative incidence of relapse in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02474290; the trial is complete.
FINDINGS


Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to sorafenib maintenance (n=100) or control (n=102). Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0). The 1-year cumulative incidence of relapse was 7·0% (95% CI 3·1-13·1) in the sorafenib group and 24·5% (16·6-33·2) in the control group (hazard ratio 0·25, 95% CI 0·11-0·57; p=0·0010). Within 210 days post-transplantation, the most common grade 3 and 4 adverse events were infections (25 [25%] of 100 patients in the sorafenib group vs 24 [24%] of 102 in the control group), acute graft-versus-host-disease (GVHD; 23 [23%] of 100 vs 21 [21%] of 102), chronic GVHD (18 [18%] of 99 vs 17 [17%] of 99), and haematological toxicity (15 [15%] of 100 vs seven [7%] of 102). There were no treatment-related deaths.
INTERPRETATION


Sorafenib maintenance post-transplantation can reduce relapse and is well tolerated in patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation. This strategy could be a suitable therapeutic option for patients with FLT3-ITD acute myeloid leukaemia.
FUNDING


None.",2020,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"['Between June 20, 2015, and July 21, 2018, 202 patients were enrolled and randomly assigned to', 'patients with FLT3-ITD acute myeloid leukaemia', 'patients with FLT3-ITD acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation', 'Eligible patients (aged 18-60 years) had FLT3-ITD acute myeloid leukaemia, were undergoing allogeneic haematopoietic stem-cell transplantation, had an Eastern Cooperative Oncology Group performance status of 0-2, had composite complete remission before and after transplantation, and had haematopoietic recovery within 60 days post-transplantation', 'seven hospitals in China', 'n=100) or control (n=102', 'patients with FLT3 internal tandem duplication (FLT3-ITD) acute myeloid leukaemia undergoing allogeneic haematopoietic stem-cell transplantation']","['sorafenib', 'sorafenib maintenance (400 mg orally twice daily) or non-maintenance (control', 'Sorafenib maintenance', 'sorafenib maintenance post-transplantation', 'sorafenib maintenance']","['chronic GVHD', '1-year cumulative incidence of relapse', 'efficacy and tolerability', 'haematological toxicity', 'acute graft-versus-host-disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0018957', 'cui_str': 'Hematopoietic system structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease'}]",202.0,0.369632,Median follow-up post-transplantation was 21·3 months (IQR 15·0-37·0).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xuan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhiping', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Xinquan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Department of Hematology, First People's Hospital of Chenzhou, Chenzhou, China.""}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Pengcheng', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhixiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chunzi', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': ""Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Sanfang', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Hematology, Zhujiang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ""Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China; Department of Hematology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Qifa', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: liuqifa628@163.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30455-1']
1609,32795428,Levonorgestrel-releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.,"BACKGROUND


Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel-releasing intrauterine system and endometrial ablation are 2 frequently applied treatments in women with heavy menstrual bleeding.
OBJECTIVE


This study aimed to compare the effectiveness of the levonorgestrel-releasing intrauterine system with endometrial ablation in women with heavy menstrual bleeding.
STUDY DESIGN


This multicenter, randomized controlled, noninferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 years and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel-releasing intrauterine system (Mirena) or endometrial ablation, performed with a bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Loss Assessment Chart score. Secondary outcomes included reintervention rates, patient satisfaction, quality of life, and sexual function.
RESULTS


We registered 645 women as eligible, of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel-releasing intrauterine system (baseline Pictorial Blood Loss Assessment Chart score, 616) and 138 women to endometrial ablation (baseline Pictorial Blood Loss Assessment Chart score, 630). At 24 months, mean Pictorial Blood Loss Assessment Chart scores were 64.8 in the levonorgestrel-releasing intrauterine system group and 14.2 in the endometrial ablation group (difference, 50.5 points; 95% confidence interval, 4.3-96.7; noninferiority, P=.87 [25 Pictorial Blood Loss Assessment Chart point margin]). Compared with 14 women (10%) in the endometrial ablation group, and 34 women (27%) underwent a surgical reintervention in the levonorgestrel-releasing intrauterine system group (relative risk, 2.64; 95% confidence interval, 1.49-4.68). There was no significant difference in patient satisfaction and quality of life between the groups.
CONCLUSION


Both the levonorgestrel-releasing intrauterine system and endometrial ablation strategies lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate noninferiority of starting with the levonorgestrel-releasing intrauterine system. Women who start with the levonorgestrel-releasing intrauterine system, a reversible and less invasive treatment, are at an increased risk of needing additional treatment compared with women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the 2 treatments.",2020,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","['women with heavy menstrual bleeding', 'heavy menstrual bleeding', 'Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology', '132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630', '645 women as eligible of whom 270 women provided informed consent', '26 hospitals and in a network of general practices in the Netherlands', 'Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment']","['levonorgestrel intrauterine system', 'levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure', 'levonorgestrel intrauterine system and endometrial ablation', 'Levonorgestrel releasing intrauterine system versus endometrial ablation']","['risk of needing additional treatment', 'mean PBAC-scores', 'menstrual blood loss', 'blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score', 're-intervention rates, patient satisfaction, quality of life, and sexual function', 'patient satisfaction and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",645.0,0.184613,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","[{'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Beelen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Department of General Practice, University of Maastricht, Maastricht, Netherlands. Electronic address: pleun.beelen@gmail.com.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'van den Brink', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Malou C', 'Initials': 'MC', 'LastName': 'Herman', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Peggy M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands.'}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Mak', 'Affiliation': 'Department of General Practice, University of Maastricht, Maastricht, Netherlands.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'van Meurs', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Sjors F', 'Initials': 'SF', 'LastName': 'Coppus', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'van der Steeg', 'Affiliation': ""Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.""}, {'ForeName': 'Heleen P', 'Initials': 'HP', 'LastName': 'Eising', 'Affiliation': 'Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn, Netherlands.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Massop-Helmink', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Twente, Netherlands.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Klinkert', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Theodoor E', 'Initials': 'TE', 'LastName': 'Nieboer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Lucet F', 'Initials': 'LF', 'LastName': 'van der Voet', 'Affiliation': 'Department of Obstetrics and Gynecology, Deventer Hospital, Deventer, Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Veersema', 'Affiliation': 'Department of Reproductive Medicine and Gynecology, University Medical Center Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Nicol A C', 'Initials': 'NAC', 'LastName': 'Smeets', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland Medical Centre, Heerlen, Netherlands.'}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Schutte', 'Affiliation': 'Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'van Baal', 'Affiliation': 'Department of Obstetrics and Gynecology, Flevo Hospital, Almere, Netherlands.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima MC, Veldhoven, Netherlands; Research School Grow, University of Maastricht, Maastricht, Netherlands.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.016']
1610,32795561,Comparative Effect of Liuzijue Qigong and Conventional Respiratory Training on Trunk Control Ability and Respiratory Muscle Function in Patients at an Early Recovery Stage From Stroke: A Randomized Controlled Trial.,"OBJECTIVES


To compare the effects of Liuzijue Qigong and conventional respiratory training on trunk control ability and respiratory muscle functions in patients at an early recovery stage from stroke.
DESIGN


A single-blind, randomized controlled trial.
SETTING


A hospital.
PARTICIPANTS


Patients (N=60) within 2 months poststroke.
INTERVENTIONS


The experimental group (n=30) received conventional rehabilitation training combined with Liuzijue exercise, and the control group (n=30) received conventional rehabilitation training combined with conventional respiration training. The training in the 2 groups was conducted 5 times per week for 3 weeks.
MAIN OUTCOME MEASURES


Trunk Impairment Scale (TIS), maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), maximum expiratory mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS), and Modified Barthel Index (MBI). All outcome measures were assessed twice (at baseline and 3 weeks).
RESULTS


Both groups significantly improved in TIS, MIP, FVC, PEF, and the change of IAP, BBS, and MBI when pre- and postassessments (P<.05) were compared. Compared with the control group, there was a significant difference in the experimental group in the static sitting balance subscale (P=.014), dynamic balance subscale (P=.001), coordination subscale (P<.001), TIS total scores (P<.001; effect size [ES]=0.9), MIP (P=.012; 95% confidence interval [CI], 2.23-17.69; ES=0.67), MEP (P=.015; 95% CI, 1.85-16.57; ES=0.65), change of IAP (P=.001), and MBI (P=.016; 95% CI, 1.51-14.16; ES=0.64). No significant differences were found between the 2 groups in FEV1 (P=.24), FVC (P=.43), PEF (P=.202), MMEF (P=.277), the diaphragmatic movement of quiet breathing (P=.146), deep breathing (P=.102), and BBS (P=.124).
CONCLUSIONS


Liuzijue exercise showed more changes than conventional respiratory training in improving trunk control ability, respiratory muscle functions, and activities of daily living ability in patients at an early recovery stage from stroke.",2020,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[' 60 patients within 2 months post-stroke', 'patients at an early recovery stage from stroke']","['Liuzijue Qigong and conventional respiratory training', 'conventional rehabilitation training combined with Liuzijue exercise, the control group', 'conventional rehabilitation training combined with conventional respiration training', 'conventional respiratory training']","['Trunk Impairment Scale (TIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Maximum Expiratory Mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS) and Modified Barthel Index (MBI', 'TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI', 'static sitting balance subscale', 'change of IAP', 'dynamic balance subscale', 'PEF', 'diaphragmatic movement of quiet breathing', 'deep breathing', 'trunk control ability and respiratory muscle function', 'MIP', 'BBS', 'MEP', 'trunk control ability, respiratory muscle functions and ADL ability', 'trunk control ability and respiratory muscle functions', 'TIS total scores', 'FEV1', 'coordination subscale', 'MBI', 'FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0232079', 'cui_str': 'Diaphragmatic movement'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0701272,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[{'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China; School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China. Electronic address: ZhangYing032317@163.com.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Shenyuan Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Gaiyan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yong', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.007']
1611,32798224,One-year decline of poliovirus antibodies following fractional-dose inactivated poliovirus vaccine.,"BACKGROUND


Fractional dose (1/5th of full intramuscular dose) of inactivated poliovirus-vaccine administered intradermally (fIPV) is used as IPV dose-sparing strategy. We compared the rate of decline of poliovirus antibodies (PVA) in recipients of either two doses of fIPV or IPV.
METHODS


Community-based randomized controlled trial was conducted in Karachi, Pakistan. Children aged 14 weeks were randomized into fIPV or full IPV study arms (A, B) and received one vaccine doses at 14 weeks and one at 9 months of age. PVA were measured at 14, 18 weeks and 10, 21 months of age.
RESULTS


Seroprevalence of poliovirus-type 2 antibodies of 170/250 (68%) enrolled children after two IPV or fIPV doses at 10 months of age in arms-A and B reached 100% vs 99% (p=0.339); and at 21 months it was 86% vs 67% (p=0.004). Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose. The slope of decline is similar for both full IPV and fIPV recipients. The results provide further evidence that fIPV is a viable option for IPV dose-sparing.",2020,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose.","['Community-based randomized controlled trial was conducted in Karachi, Pakistan', 'recipients of either two doses of fIPV or IPV', 'Children aged 14 weeks']","['inactivated poliovirus-vaccine administered intradermally (fIPV', 'fractional-dose inactivated poliovirus vaccine']","['antibody-titers in log2 scale', 'poliovirus antibodies', 'PVA', 'rate of decline of poliovirus antibodies (PVA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.169346,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose.","[{'ForeName': 'Ali Faisal', 'Initials': 'AF', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Mach', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Yousafzai', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zaubina', 'Initials': 'Z', 'LastName': 'Kazi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Attaullah', 'Initials': 'A', 'LastName': 'Baig', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Vishali', 'Initials': 'V', 'LastName': 'Jeyaseelan', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'Sutter', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa504']
1612,32803641,"Central Sleep Apnea in Patients with Heart Failure-How to Screen, How to Treat.","PURPOSE OF REVIEW


Central sleep apnea occurs in up to 50% of heart failure patients and worsens outcomes. Established therapies are limited by minimal supporting evidence, poor patient adherence, and potentially adverse cardiovascular effects. However, transvenous phrenic nerve stimulation, by contracting the diaphragm, restores normal breathing throughout sleep and has been shown to be safe and effective. This review discusses the mechanisms, screening, diagnosis, and therapeutic approaches to CSA in patients with HF.
RECENT FINDINGS


In a prospective, multicenter randomized Pivotal Trial (NCT01816776) of transvenous phrenic nerve stimulation with the remedē System, significantly more treated patients had a ≥ 50% reduction in apnea-hypopnea index compared with controls, with a 41 percentage point difference between group difference at 6 months (p < 0.0001). All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients. Freedom from serious related adverse events at 12 months was 91%. Benefits are sustained to 36 months. Transvenous phrenic nerve stimulation improves quality of life in patients with heart failure and central sleep apnea. Controlled trials evaluating the impact of this therapy on mortality/heart failure hospitalizations and ""real world"" experience are needed to confirm safety and effectiveness.",2020,"All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients.","['patients with HF', 'Patients with Heart Failure', 'patients with heart failure and central sleep apnea']","['Transvenous phrenic nerve stimulation', 'transvenous phrenic nerve stimulation']","['quality of life', 'Central Sleep Apnea', 'sleep, quality of life, and daytime sleepiness endpoints', 'apnea-hypopnea index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}]","[{'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0357139,"All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients.","[{'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Heart Failure Research, Advocate Heart Institute, Naperville, IL, USA. mariarosa.costanzo@advocatehealth.com.'}]",Current heart failure reports,['10.1007/s11897-020-00472-0']
1613,32803669,Lenalidomide: A Review in Previously Treated Follicular Lymphoma.,"Lenalidomide (Revlimid ® ) is a targeted immunomodulatory drug with multiple mechanisms of action. In the USA and the EU, oral lenalidomide is indicated in combination with rituximab or a rituximab product for the treatment of patients with previously treated follicular lymphoma. In the pivotal, phase III AUGMENT trial, lenalidomide + rituximab significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo + rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma, with the PFS benefit appearing to be specific to patients with follicular lymphoma and extending to elderly patients with this subtype. Lenalidomide + rituximab also demonstrated activity in an interim analysis of the phase III MAGNIFY trial in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including those with rituximab-refractory disease. Lenalidomide had an acceptable tolerability profile. Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support. In conclusion, lenalidomide in combination with rituximab represents an important new treatment option for previously treated follicular lymphoma, including patients whose disease has become refractory to rituximab.",2020,"Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support.","['patients with relapsed or refractory indolent non-Hodgkin lymphoma, including those with rituximab-refractory disease', 'patients with previously treated follicular lymphoma', 'patients with relapsed or refractory indolent non-Hodgkin lymphoma']","['placebo + rituximab', 'Lenalidomide', 'lenalidomide + rituximab', 'Lenalidomide (Revlimid ® ', 'rituximab', 'Lenalidomide + rituximab']","['acceptable tolerability profile', 'neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1135145', 'cui_str': 'Revimid'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",,0.0292288,"Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support.","[{'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Blair', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01381-1']
1614,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1615,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
1616,32798588,Anti-erosive effect of rinsing before or after toothbrushing with a Fluoride/Stannous Ions solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F - /Sn 2+ -containing mouthrinse before or after toothbrushing with a F - /Sn 2+ /chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all μm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F - /Sn 2+ /chitosan toothpaste reduced enamel surface loss. Additional rinsing with F - /Sn 2+  mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
1617,32799029,Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women.,"STUDY OBJECTIVES


To determine whether insomnia patients with objective sleep disturbance are less responsive to cognitive and behavioral treatments than those without objective sleep disturbance, characterize effects of insomnia therapy on objective sleep, and determine whether reductions in nocturnal cognitive arousal correspond to changes in objective sleep.
METHODS


Secondary analysis of a single-site, randomized controlled trial. 113 postmenopausal women (56.40 ± 5.34 years) with menopause-related insomnia disorder were randomized to three treatment conditions: cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control. Primary outcomes were the Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters and were collected at pretreatment, posttreatment, and six-month follow-up.
RESULTS


Patients with lower pretreatment PSG sleep efficiency had lower rates of insomnia remission after active treatment relative to those with higher sleep efficiency (37.8% vs 61.8%). Neither CBTI and SRT produced clinically meaningful effects on PSG sleep. Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
CONCLUSIONS


Our findings support an emerging literature suggesting that insomnia patients with objective sleep disturbance may have blunted response to insomnia therapy. Research is needed to enhance treatments to better improve insomnia in patients with objective sleep disturbance. A lack of observed CBTI and SRT effects on PSG sleep suggests that these therapies may be presently ill-designed to improve objective sleep. Nocturnal cognitive arousal may represent an entry point to improve objective sleep latency in insomnia. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.",2020,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","['insomnia patients with objective sleep disturbance', 'postmenopausal women', 'patients with objective sleep disturbance', '113 postmenopausal women (56.40\xa0±\xa05.34 years) with menopause-related insomnia disorder']","['NAME', 'CBTI and SRT', 'cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control']","['Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters', 'PSG sleep', 'nocturnal cognitive arousal', 'Nocturnal cognitive arousal', 'PSG sleep latency', 'sleep efficiency', 'insomnia remission']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",113.0,0.0431924,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Chaewon', 'Initials': 'C', 'LastName': 'Sagong', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA. Electronic address: cdrake1@hfhs.org.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.024']
1618,32799042,Continuous positive airway pressure effectively ameliorates arrhythmias in patients with obstructive sleep apnea-hypopnea via counteracting the inflammation.,"INTRODUCTION


This work is aimed at evaluating the therapeutic effect of continuous positive airway pressure (CPAP) in treatment of patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) combined with arrhythmias as well as clarifying the possible mechanism underpinning such an intervention.
METHODS


Through exclusions, a total of 108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work. A computerized permuted block design with varying block stratification and size according to age, sex, AHI and type of arrhythmia was used to randomize 108 patients to CPAP versus sham CPAP for a period of 12-week. All were subjected to unchanged pharmacological anti-arrhythmia therapy combined with CPAP. Before and after CPAP treatment, the improvement of various arrhythmias was compared between the CPAP group and the sham-CPAP group. The levels of CRP, IL-6 and TNF-ɑ were measured simultaneously.
RESULTS


During follow-up, the mean (±SD) CPAP pressure used in the CPAP group was 12.3 (±3.1) cm H2O. The use of CPAP and sham CPAP was on average of 5.2 ± 0.56 and 5.1 ± 0.63 h/night, respectively. After 12 weeks of CPAP therapy, the AHI was significantly decreased and the lowest blood oxygen saturation was notably elevated in the CPAP group compared to the sham-CPAP group, P < 0.05. The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS. The level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) was significantly lower in the CPAP group than in the sham-CPAP group (P < 0.05). Pearson correlation analysis showed that the reduction in the incidence of total arrhythmias was positively correlated with the decrease of CRP, IL-6 and TNF-ɑ levels, respectively.
CONCLUSION


Findings from this work suggest that proper use of CPAP significantly benefits to OSAHS patients combined with arrhythmias, possibly via counteracting the inflammation.",2020,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","['patients with obstructive sleep apnea-hypopnea via counteracting the inflammation', '108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work', 'patients with obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with OSAHS']","['CPAP versus sham CPAP', 'CPAP', 'continuous positive airway pressure (CPAP', 'pharmacological anti-arrhythmia therapy combined with CPAP', 'Continuous positive airway pressure', 'CPAP and sham CPAP']","['mean (±SD) CPAP pressure', 'incidence of total arrhythmias', 'lowest blood oxygen saturation', 'improvement of various arrhythmias', 'CRP, IL-6 and TNF-ɑ levels', 'level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', 'incidence of all types of arrhythmia', 'levels of CRP, IL-6 and TNF-ɑ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",108.0,0.024615,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","[{'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 250021, PR China. Electronic address: zg000507@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102655']
1619,32799922,"Cortical priming strategies for gait training after stroke: a controlled, stratified trial.","BACKGROUND


Stroke survivors experience chronic gait impairments, so rehabilitation has focused on restoring ambulatory capacity. High-intensity speed-based treadmill training (HISTT) is one form of walking rehabilitation that can improve walking, but its effectiveness has not been thoroughly investigated. Additionally, cortical priming with transcranial direct current stimulation (tDCS) and movement may enhance HISTT-induced improvements in walking, but there have been no systematic investigations. The objective of this study was to determine if motor priming can augment the effects of HISTT on walking in chronic stroke survivors.
METHODS


Eighty-one chronic stroke survivors participated in a controlled trial with stratification into four groups: 1) control-15 min of rest (n = 20), 2) tDCS-15 min of stimulation-based priming with transcranial direct current stimulation (n = 21), 3) ankle motor tracking (AMT)-15 min of movement-based priming with targeted movements of the ankle and sham tDCS (n = 20), and 4) tDCS+AMT-15 min of concurrent tDCS and AMT (n = 20). Participants performed 12 sessions of HISTT (40 min/day, 3 days/week, 4 weeks). Primary outcome measure was walking speed. Secondary outcome measures included corticomotor excitability (CME). Outcomes were measured at pre, post, and 3-month follow-up assessments.
RESULTS


HISTT improved walking speed for all groups, which was partially maintained 3 months after training. No significant difference in walking speed was seen between groups. The tDCS+AMT group demonstrated greater changes in CME than other groups. Individuals who demonstrated up-regulation of CME after tDCS increased walking speed more than down-regulators.
CONCLUSIONS


Our results support the effectiveness of HISTT to improve walking; however, motor priming did not lead to additional improvements. Upregulation of CME in the tDCS+AMT group supports a potential role for priming in enhancing neural plasticity. Greater changes in walking were seen in tDCS up-regulators, suggesting that responsiveness to tDCS might play an important role in determining the capacity to respond to priming and HISTT.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03492229. Registered 10 April 2018 - retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03492229 .",2020,No significant difference in walking speed was seen between groups.,"['chronic stroke survivors', 'gait training after stroke', 'Eighty-one chronic stroke survivors participated in a controlled trial with stratification into four groups: 1', 'Registered 10 April 2018 - retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03492229 ']","['transcranial direct current stimulation (tDCS', 'tDCS+AMT', 'High-intensity speed-based treadmill training (HISTT', 'control-15\u2009min of rest (n\u2009=\u200920), 2) tDCS-15\u2009min of stimulation-based priming with transcranial direct current stimulation (n\u2009=\u200921), 3) ankle motor tracking (AMT)-15\u2009min of movement-based priming with targeted movements of the ankle and sham tDCS (n\u2009=\u200920), and 4) tDCS+AMT-15\u2009min of concurrent tDCS and AMT', 'HISTT']","['walking speed', 'corticomotor excitability (CME', 'CME']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0063517', 'cui_str': 'indopan'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",,0.106953,No significant difference in walking speed was seen between groups.,"[{'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Madhavan', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA. smadhava@uic.edu.'}, {'ForeName': 'Brice T', 'Initials': 'BT', 'LastName': 'Cleland', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sivaramakrishnan', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'University of Illinois at Chicago, Epidemiology and Biostatistics, Chicago, IL, USA.'}, {'ForeName': 'Hyosok', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA.'}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Testai', 'Affiliation': 'University of Illinois at Chicago, Department of Neurology and Rehabilitation, Chicago, IL, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': 'Northwestern University, Physical Therapy & Human Movement Sciences, Chicago, IL, USA.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00744-9']
1620,32800398,Effect of licorice on patients with HSD11B1 gene polymorphisms- a pilot study.,"The positive association of HSD11B1 gene polymorphism with type 2 diabetes (T2D) and prediabetic conditions has been revealed. In the current study, we assessed the effectiveness of licorice on the clinical profile of the patients with HSD11B1 gene polymorphism. Licorice (Glycyrrhiza Glabra) is a competitive inhibitor of 11 beta-hydroxysteroid dehydrogenase 1 (11β-HSD1) enzyme and has been traditionally reported as an anti-ulcer, anti-pyretic, anti-thirst, anti-inflammatory, hypoglycemic and hypolipidemic agent. The aim of the study was to assess the effectiveness of licorice on the clinical profile of participants with HSD11B1 gene polymorphism. The study was performed using diabetic patients with HSD11B1 gene polymorphism. Biochemical and anthropometric parameters were measured using standard diagnostic tools. Fourteen patients were divided into two groups by simple randomization, Licorice group (treated with 750 mg licorice/day for three weeks), and placebo group (treated with 750 mg placebo/day for three weeks). Investigations were repeated at the end of three weeks. Licorice showed a significant reduction in serum insulin levels (p = 0.03). There was no significant change in any other clinical parameters either by licorice or placebo. Conclusively, licorice moderately improves serum insulin levels in patients with HSD11B1 gene polymorphism. From our pilot study, the safety of licorice is confirmed at a dose of 750 mg/day. However, the study can be repeated at a higher dose to show its effectiveness and safety.",2020,Licorice showed a significant reduction in serum insulin levels (p = 0.03).,"['participants with HSD11B1 gene polymorphism', 'diabetic patients with HSD11B1 gene polymorphism', 'Fourteen patients', 'patients with HSD11B1 gene polymorphism', 'patients with HSD11B1 gene polymorphisms- a pilot study']","['Licorice (Glycyrrhiza Glabra', 'licorice', 'placebo']","['serum insulin levels', 'Biochemical and anthropometric parameters']","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.0509751,Licorice showed a significant reduction in serum insulin levels (p = 0.03).,"[{'ForeName': 'Nayana', 'Initials': 'N', 'LastName': 'Devang', 'Affiliation': 'Department of Biotechnology, National Institute of Technology Calicut, NIT Campus (P.O.), Calicut, 673601, Kerala, India. Electronic address: devangnayana@gmail.com.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Adhikari', 'Affiliation': 'Department of Medicine, Yenepoya Medical College, Yenepoya University, Mangalore, 575018, Karnataka, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nandini', 'Affiliation': 'Department of Biochemistry, Kasturba Medical College, Manipal University, Mangalore, 575003, Karnataka, India.'}, {'ForeName': 'Kapaettu', 'Initials': 'K', 'LastName': 'Satyamoorthy', 'Affiliation': 'Department of Biotechnology, School of Life Sciences, Manipal University, Manipal, 576104, Karnataka, India.'}, {'ForeName': 'Padmalatha S', 'Initials': 'PS', 'LastName': 'Rai', 'Affiliation': 'Department of Biotechnology, School of Life Sciences, Manipal University, Manipal, 576104, Karnataka, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.06.006']
1621,32800962,The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury.,"There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 27,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.",2020,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"['persons with chronic spinal cord injury', 'Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care', 'people with immobilization due to SCI']",['exoskeletal-assisted walking'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0719972,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Spungen', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Ann.Spungen@va.gov.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: William.Bauman@va.gov.'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Kousick.Biswas@va.gov.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Jones', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Karen.Jones2@va.gov.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Snodgrass', 'Affiliation': 'VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM 87106, United States of America; University of New Mexico, College of Pharmacy, Albuquerque, NM 87106, United States of America. Electronic address: Amanda.Snodgrass@va.gov.'}, {'ForeName': 'Lance L', 'Initials': 'LL', 'LastName': 'Goetz', 'Affiliation': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA 23249, United States of America; Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA 23298, United States of America. Electronic address: Lance.Goetz@va.gov.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gorman', 'Affiliation': 'Department of Neurology, University of Maryland School of Medicine, Baltimore, MD 21201, United States of America; VA Maryland Healthcare System, Baltimore, MD 21201, United States of America. Electronic address: Pgorman@umm.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Institute for Rehabilitation, West Orange, NJ 07052, United States of America; Rutgers New Jersey Medical School, Newark, NJ 07103, United States of America; Kessler Foundation, West Orange, NJ 07052, United States of America. Electronic address: skirshblum@kessler-rehab.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sabharwal', 'Affiliation': 'VA Boston Health Care System, Boston, MA 02130, United States of America; Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: Sunil.Sabharwal2@va.gov.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'White', 'Affiliation': ""James A Haley Veterans' Hospital, Tampa, FL 33612, United States of America; University of South Florida, Tampa, FL 33612, United States of America. Electronic address: Kevin.White2@va.gov.""}, {'ForeName': 'Pierre K', 'Initials': 'PK', 'LastName': 'Asselin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Pierre.Asselin@va.gov.'}, {'ForeName': 'Kel G', 'Initials': 'KG', 'LastName': 'Morin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Kel.Morin@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Christopher.Cirnigliaro@va.gov.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC 20420, United States of America. Electronic address: Grant.Huang@va.gov.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106102']
1622,32800969,"Yokukansan for Treatment of Preoperative Anxiety and Prevention of Postoperative Delirium in Cancer Patients Undergoing Highly Invasive Surgery. J-SUPPORT 1605 (ProD Study): A Randomized, Double-Blind, Placebo-Controlled Trial.","CONTEXT


No standard preventive or therapeutic methods have been established for preoperative anxiety and postoperative delirium in patients with cancer.
OBJECTIVES


To clarify the therapeutic effect of yokukansan for perioperative psychiatric symptoms in patients with cancer as well as to confirm its safety profile.
METHODS


This is a randomized, double-blind, and placebo-controlled trial conducted at a single center in Tokyo, Japan. About 195 patients with cancer scheduled to undergo tumor resection took one packet of the study drug, which was administered orally. Coprimary outcomes were change in preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Interim analysis was performed with one-third (n = 74) of the target number of registered patients.
RESULTS


Because this trial was canceled based on the results of the interim analysis and the protocol treatment was discontinued in patients who were already registered, conclusions were based on the full analysis set of 160 participants. There were no significant differences between groups in the change of mean Hospital Anxiety and Depression Scale-Anxiety score (intervention group [SD] 0.4 [3.0] vs. placebo group 0.5 [3.0]; P = 0.796) or the incidence of postoperative delirium (32% vs. 30%; P = 0.798). There were no serious adverse events in either group.
CONCLUSION


In patients with cancer undergoing highly invasive surgeries, yokukansan demonstrated no significant efficacy for the treatment of preoperative anxiety or the prevention of postoperative delirium. Yokukansan is already used in daily practice in Japan, but we should be careful with its future use.",2020,"There were no significant differences between groups in the change of mean HADS-A score (intervention group [SD], 0.4 [3.0] vs. placebo group, 0.5 [3.0]; p=0.796) or the incidence of postoperative delirium (32% vs. 30%; p=0.798).","['patients who were already registered', 'cancer patients undergoing highly invasive surgery', 'cancer patients', 'single center in Tokyo, Japan', '195 cancer patients scheduled to undergo tumor resection took one packet of the study drug was administered orally', 'cancer patients undergoing highly invasive surgeries']","['yokukansan', 'Yokukansan', 'placebo']","['change of mean HADS-A score', 'preoperative anxiety', 'incidence of postoperative delirium', 'serious adverse events', 'preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C2001636', 'cui_str': 'Yi-Gan San'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]",195.0,0.5259,"There were no significant differences between groups in the change of mean HADS-A score (intervention group [SD], 0.4 [3.0] vs. placebo group, 0.5 [3.0]; p=0.796) or the incidence of postoperative delirium (32% vs. 30%; p=0.798).","[{'ForeName': 'Saho', 'Initials': 'S', 'LastName': 'Wada', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yutaka J', 'Initials': 'YJ', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Tetsufumi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesia and Intensive Care, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Head and Neck Surgery, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daiko', 'Affiliation': 'Department of Esophageal Surgery, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kawai', 'Affiliation': 'Department of Musculoskeletal Oncology and Rehabilitation, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Tomoyasu', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gynecology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Department of Psycho-Oncology, Cancer Institute Hospital of JFCR, Koto-ku, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan. Electronic address: ken.shimizu@jfcr.or.jp.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.009']
1623,32771369,Evaluation of a computerized contraceptive decision aid: A randomized controlled trial.,"OBJECTIVE


To evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception.
STUDY DESIGN


We conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit.
RESULTS


We enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group.
CONCLUSIONS


Decisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception.
IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.",2020,"IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception.","['women presenting for reversible contraception at two clinics affiliated with an academic medical center', 'women seeking reversible contraception', 'We enrolled and randomized 253 women, and 241 had complete data for our primary outcome']",['contraceptive decision aid'],"['contraceptive method chosen and satisfaction with the healthcare visit', 'change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale', 'decisional conflict score', 'decisional conflict, alter method choice, or impact satisfaction', 'median decisional conflict', 'Overall, pre-visit decisional conflict scores', 'decisional conflict']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",253.0,0.126585,"IMPLICATIONS


Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception.","[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Madden', 'Affiliation': 'Divisions of Family Planning & Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63110, USA. Electronic address: maddent@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Holttum', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health, University of Minnesota Medical School, 515 Mayo Memorial Building, Moos Tower 12th Floor, Minneapolis, MN 55455, USA.""}, {'ForeName': 'Ragini', 'Initials': 'R', 'LastName': 'Maddipati', 'Affiliation': 'Brown School, Washington University in St. Louis, 1 Brookings Dr, St. Louis, MO 63130, USA.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Secura', 'Affiliation': 'Divisions of Family Planning & Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, 4901 Forest Park Avenue, Mailstop: 8064-37-1005, St. Louis, MO 63110, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Nease', 'Affiliation': 'ExpressScripts, 1 Express Way, St. Louis, MO 63121, USA.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, 550 University Blvd, University Hospital 2440, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Politi', 'Affiliation': 'Division of Public Health Sciences, Department of Surgery, Washington University in St. Louis School of Medicine, 660 S. Euclid, Campus Box 8100, St. Louis, MO 631110, USA.'}]",Contraception,['10.1016/j.contraception.2020.08.002']
1624,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1625,32771909,Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa.,"BACKGROUND


South Africa has the highest HIV prevalence globally, which disproportionately affects women. Hazardous alcohol use reduces antiretroviral adherence which can lead to adverse health. Few evidence-based interventions addressing hazardous alcohol use and HIV have been implemented in real-world settings. This study aimed to evaluate implementation outcomes from the Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town.
METHODS


We conducted this implementation science trial using a modified stepped-wedge design. Four health clinics were paired with four substance use rehabilitation programs and randomized into four cycles. Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle). We assessed adoption, acceptability, appropriateness, cost, and fidelity using a mixed methods approach.
RESULTS


Adoption: 100 % of staff trained in the WHC and designated as interventionists delivered one or more workshops. Acceptability: Interventionists found the WHC content beneficial to their patients and the WHC improved connections between clinical units in facilities. Appropriateness: The WHC aligned with facility goals to improve antiretroviral adherence and reduce alcohol use; however, there were implementation challenges, including staff shortages, stigma, and few places to refer women for supportive services. Cost: The cost of implementing the WHC was 20.59 ZAR (1.40 USD) per attendee. Fidelity: Interventionists implemented the WHC with high fidelity and quality.
CONCLUSIONS


The findings suggest it is feasible to integrate the WHC into usual-care settings. Future efforts to scale up the intervention will need to address social and structural implementation challenges.
TRIAL REGISTRATION


NCT02733003 approved 1/21/2016.",2020,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[""Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town"", 'usual-care settings in South Africa', 'Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle', 'Four health clinics']",['gender-focused HIV and alcohol risk-reduction intervention'],"['Acceptability', 'Fidelity', 'adoption, acceptability, appropriateness, cost, and fidelity', 'antiretroviral adherence', 'Cost', 'cost of implementing the WHC']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}]",,0.0625822,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[{'ForeName': 'Margaret W', 'Initials': 'MW', 'LastName': 'Gichane', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA; Department of Psychology, North Carolina State University, 2310 Katharine Stinson Drive Raleigh, Raleigh, NC, 27607, USA; Psychiatry and Behavioral Sciences, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA. Electronic address: wmw@rti.org.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Brittni', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Zule', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108206']
1626,32778902,Further effects of electromechanically assisted gait trainer (Exowalk®) in patients with chronic stroke: A randomized controlled trial.,"OBJECTIVE


To assess the effect on walking ability of electromechanically assisted gait training with a gait trainer (Exowalk®) for patients with chronic stroke.
DESIGN


Randomized controlled trial.
SUBJECTS


Forty patients with hemiplegia after stroke.
METHODS


Patients were randomly assigned to control and experimental groups. The control group underwent physical therapist-assisted gait training and the experimental group underwent electromechanically assisted gait training. Interventions were provided for 60 min, 5 days a week, for a period of 2 weeks. Primary outcome was change in Functional Ambulatory Category. Secondary outcomes were walking speed, walking capacity, leg muscle strength and balance. All outcomes were measured before and after the intervention.
RESULTS


Although the Functional Ambulatory Category improved significantly after gait training in both groups, the change in Functional Ambulatory Category did not differ between groups. In both groups most secondary outcomes also improved after gait training, but the changes in secondary outcomes did not differ between groups.
CONCLUSION


In patients with chronic stroke, walking improved after gait training with or without electromechanical assistance. Electromechanically assisted gait training was not superior to conventional physiotherapy.",2020,"In both groups most secondary outcomes also improved after gait training, but the changes in secondary outcomes did not differ between groups.
","['Forty patients with hemiplegia after stroke', 'Patients', 'patients with chronic stroke']","['Electromechanically assisted gait training', 'electromechanically assisted gait trainer with Exowalk®', 'physical therapist-assisted gait training and the experimental group underwent electromechanically assisted gait training', 'gait training with or without electromechanical assistance', 'electromechanically assisted gait training with a gait trainer (Exowalk®']","['gait training', 'change in Functional Ambulatory Category', 'Functional Ambulatory Category', 'walking speed, walking capacity, leg muscle strength and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",40.0,0.138863,"In both groups most secondary outcomes also improved after gait training, but the changes in secondary outcomes did not differ between groups.
","[{'ForeName': 'Yeon-Gyo', 'Initials': 'YG', 'LastName': 'Nam', 'Affiliation': 'Rehabilitation Medicine, Graduate School of Dongguk University, Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Ho Jun', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Ki Yeun', 'Initials': 'KY', 'LastName': 'Nam', 'Affiliation': ''}, {'ForeName': 'Myong Ryol', 'Initials': 'MR', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Chang Seon', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Liguo', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2723']
1627,32776173,Visual motion perception improvements following direct current stimulation over V5 are dependent on initial performance.,"Transcranial direct current stimulation (tDCS) can improve visual perception. However, the effect of tDCS on visual perception is largely variable, possibly due to individual differences in initial performance. The goal of the present study was to evaluate the dependency of visual motion perception improvements on initial performance. Twenty-eight observers were randomly divided into two groups. Anodal tDCS and sham stimulation were separately applied to V5 (1.5 mA, 20 min), while observers performed a coherent motion direction identification task. The results showed that compared to sham stimulation, anodal tDCS induced a significant improvement in motion perception that lasted at least 20 min. In addition, the degree of improvement was dependent on initial performance, with a greater improvement magnitude observed for those with poorer initial performance. These results may have implications for understanding the nature of the stimulation rule and for the use of a customised stimulation protocol to enhance tDCS efficiency in practical applications.",2020,"The results showed that compared to sham stimulation, anodal tDCS induced a significant improvement in motion perception that lasted at least 20 min.",['Twenty-eight observers'],"['Anodal tDCS and sham stimulation', 'Transcranial direct current stimulation (tDCS', 'tDCS']","['motion perception', 'visual perception']","[{'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0026598', 'cui_str': 'Perception of movement'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",28.0,0.0186309,"The results showed that compared to sham stimulation, anodal tDCS induced a significant improvement in motion perception that lasted at least 20 min.","[{'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Scholl of Nursing, Yueyang Vocational Technical College, Yueyang, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ""Department of Nursing, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Pengbo', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China. 42958732@qq.com.""}]",Experimental brain research,['10.1007/s00221-020-05842-7']
1628,32776533,One-year results of 0.01% atropine with orthokeratology (AOK) study: a randomised clinical trial.,"PURPOSE


To report the 1-year results of an investigation into whether there is an additive effect between 0.01% atropine and orthokeratology (ortho-k), in a single-masked, two-arm, randomised controlled trial: Combined Atropine with Orthokeratology (AOK) for myopia control study (ClinicalTrials.gov number: NCT02955927).
METHODS


Chinese children aged between 6 and 11 years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia, were randomly assigned either to an AOK group or ortho-k only (OK) group at a 1:1 ratio. Subjects in the AOK group instilled one drop of 0.01% atropine into each eye, 10 min before nightly wear of ortho-k lenses. The primary outcome, axial elongation, was examined at 6-monthly intervals, along with secondary outcomes including best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography.
RESULTS


29 AOK and 30 OK subjects completed the 1-year visit. The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p = 0.03). A significant between-group difference in axial elongation was observed over the first 6-month period only (p < 0.001), but not over the second period (p = 0.818). At the 1-year visit, increases in mean (S.D.) mesopic and photopic pupil sizes in the AOK group were 0.64 (0.48) mm and 0.36 (0.34) mm, respectively, which were significantly higher than 0.10 (0.50) mm and 0.02 (0.28) mm in the OK group (p < 0.001). At the 6-month visit, a significant moderate negative correlation was found between axial elongation and the increase in photopic pupil size (r = -0.42, p = 0.02) in the AOK group.
CONCLUSIONS


There is an additive effect between 0.01% atropine and ortho-k over one year, with mean axial elongation in the AOK group 0.09 mm slower than that in the OK group. It appears that the additive effect was only during the first six months; a second-year investigation is warranted to determine whether the effect is sustained over time.",2020,"The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p =","['Chinese children aged between 6 and 11\xa0years with 1.00-4.00 D of myopia, astigmatism <2.50 D, and no more than 1.00 D anisometropia']","['AOK group or ortho-k only (OK', 'atropine and orthokeratology (ortho-k', 'Atropine with Orthokeratology (AOK', 'atropine', 'atropine with orthokeratology']","['overall axial elongation rate', 'mean (S.D.) mesopic and photopic pupil sizes', 'mean axial elongation', 'photopic pupil size', 'best-corrected visual acuity (BCVA), manifest refraction, accommodation, pupil size, and corneal topography', 'axial elongation']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0003081', 'cui_str': 'Anisometropia'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}]",,0.168199,"The overall axial elongation rate was significantly slower in the AOK group than in the OK group (mean (S.D.), 0.07 (0.16) mm vs 0.16 (0.15) mm, respectively; p =","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.'}, {'ForeName': 'Alex Lk', 'Initials': 'AL', 'LastName': 'Ng', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Bonnie Nk', 'Initials': 'BN', 'LastName': 'Choy', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'George Pm', 'Initials': 'GP', 'LastName': 'Cheng', 'Affiliation': 'Hong Kong Laser Eye Centre, Hong Kong SAR, China.'}, {'ForeName': 'Victor Cp', 'Initials': 'VC', 'LastName': 'Woo', 'Affiliation': 'Department of Ophthalmology, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Cho', 'Affiliation': 'School of Optometry, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China.'}]",Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists),['10.1111/opo.12722']
1629,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
1630,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
1631,32773226,Effect of Ezetimibe + Pitavastatin on Cardiovascular Outcomes in Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study).,"Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI). This study aimed to evaluate the effect of intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe, on patients with STEMI. We therefore undertook a post hoc subanalysis of the HIJ-PROPER study's data that examined the clinical outcomes of the patients with dyslipidemia and STEMI (n = 880) who received pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group), and we evaluated their cardiovascular events. The primary end point was a composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization. During the median 3.4-year follow-up period, the cumulative rates of the primary end point were 31.9% and 39.7% in the intensive lipid-lowering therapy and standard lipid-lowering therapy groups, respectively (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.62 to 0.97; p = 0.02). Compared with the standard lipid-lowering therapy group, the intensive lipid-lowering therapy group had significantly lower all-cause death (6.9% vs 3.2%; HR, 0.45; 95% CI, 0.23 to 1.84; p = 0.01) and nonfatal stroke (2.9% vs 1.6%; HR, 0.77; 95% CI, 0.62 to 0.97; p = 0.02) rates. Patients with pitavastatin and ezetimibe therapy, as compared with pitavastatin monotherapy, had a lower cardiovascular event in STEMI patients. In conclusion, adding ezetimibe to statin therapy may be beneficial for patients with dyslipidemia and STEMI.",2020,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"['Patients with ST-Segment Elevation Myocardial Infarction (from the HIJ-PROPER Study', 'patients with dyslipidemia and STEMI', 'patients with dyslipidemia and STEMI (n\u202f=\u202f880) who received', 'patients with STEMI', 'patients with ST-segment elevation myocardial infarction (STEMI']","['intensive lipid-lowering therapy, which comprised pitavastatin and ezetimibe', 'Lipid-lowering therapy', 'pitavastatin and ezetimibe therapy (intensive lipid-lowering therapy group) or pitavastatin monotherapy (standard lipid-lowering therapy group', 'ezetimibe', 'pitavastatin and ezetimibe therapy', 'Ezetimibe\u202f+\u202fPitavastatin', 'pitavastatin monotherapy', 'standard lipid-lowering therapy']","['cumulative rates', 'cause death', 'cardiovascular event rates', 'nonfatal stroke', 'Cardiovascular Outcomes', 'composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, unstable angina, and ischemia-driven revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",880.0,0.0372168,Lipid-lowering therapy is necessary to reduce cardiovascular event rates in patients with ST-segment elevation myocardial infarction (STEMI).,"[{'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Otsuki', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: j.yamaguchi0110@gmail.com.""}, {'ForeName': 'Erisa', 'Initials': 'E', 'LastName': 'Kawada-Watanabe', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, Tokyo, Japan.""}]",The American journal of cardiology,['10.1016/j.amjcard.2020.06.069']
1632,32773581,"The effect of aspirin on preeclampsia, intrauterine growth restriction and preterm delivery among healthy pregnancies with a history of preeclampsia.","BACKGROUND


Due to the significance of preeclampsia (PE) and its adverse outcomes in the health of both mother and newborn, the present study was carried out to investigate the effect of aspirin on preventing the occurrence of PE, intrauterine growth restriction (IUGR), and preterm delivery in women with a previous history of PE.
METHODS


The present clinical trial was conducted on 90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018. The subjects of the study were randomly assigned into two groups of intervention and control to receive either 80 mg of aspirin or placebo daily during the pregnancy. Patients' information was obtained and recorded upon entering the study, follow-up visits, and childbirth.
RESULTS


Among participants who entered the clinical trial, 86 patients (95.6%) completed the study. During the pregnancy, systolic blood pressure increased by 8.25 ± 14.83 and 19.06 ± 18.33 mmHg in aspirin and placebo groups, respectively (p = 0.001). Also, the same happened with diastolic blood pressure (6.12 ± 11.46 vs 13.48 ± 13.95 mmHg, p = 0.010). The rate of PE was equal to 27 (62.8%) and 38 (88.4%) in the aspirin and placebo groups, respectively (aOR = 0.23, p = 0.013). In the aspirin group, the rate of IUGR was equal to 27.9% compared with 25.6% of newborns in the control group (aOR = 1.18, p = 0.750). Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p = 0.061).
CONCLUSION


The findings of the present study conducted exclusively on women with previous documented PE revealed that taking aspirin may have a preventive effect on PE in the current pregnancy.",2020,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","['participants who entered the clinical trial, 86 patients (95.6%) completed the study', '90 pregnant women with a previous history of PE referred to the Khalij Fars Hospital in Bandar Abbas, Hormozgan Province Iran from April 2017 to August 2018', 'healthy pregnancies with a history of preeclampsia']","['intervention and control to receive either 80 mg of aspirin or placebo', 'aspirin', 'placebo']","['rate of IUGR', 'preeclampsia, intrauterine growth restriction and preterm delivery', 'rate of PE', 'systolic blood pressure', 'diastolic blood pressure', 'occurrence of PE, Intrauterine Growth Restriction (IUGR), and preterm delivery', 'rate of preterm delivery']","[{'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",90.0,0.0760191,"Similarly, there was no significant difference in the rate of preterm delivery between the two groups (p=0.061).
","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Abdi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Rozrokh', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Zare', 'Affiliation': 'Epidemiology Department, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Hessami', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000400']
1633,32773596,"Effect of combined pharmacological, behavioral, and physical interventions for procedural pain on salivary cortisol and neurobehavioral development in preterm infants: a randomized controlled trial.","Repeated procedural pain may lead to increased secretion of cortisol and future neurobehavioral development disorders in preterm infants. Changes in the cortisol level may mediate the effect of neonatal repetitive procedural pain on altered childhood neurobehavioral development in preterm infants. However, few studies have investigated the effect of combined pharmacological, behavioral, and physical interventions over repeated painful procedures on pain response, cortisol level, and neurobehavioral development. This study examined (1) the efficacy and safety of sucrose combined with massage, music, non-nutritive sucking, and gentle human touch to treat preterm infants with repeated procedural pain; (2) the cortisol level at discharge from the neonatal intensive care unit (NICU); (3) neurobehavioral development at 40 weeks' corrected gestational age; and (4) the potential mediating effect of the cortisol level in the combined interventions on neurobehavioral development. Stable preterm infants (n = 76) were randomized to receive routine care or combined interventions across repeated painful procedures throughout their NICU stay. The Premature Infant Pain Profile scores in the early, middle, and late periods of the NICU stay were measured, as were the basal salivary cortisol level at admission and discharge, the Neonatal Behavioral Neurological Assessment score at 40 weeks' corrected gestational age, and the incidence of adverse effects during the study period. Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants. This effect may have been mediated through decreased cortisol levels and reduced repeated procedural pain.",2020,"Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants.","['Stable preterm infants (n=76', ""preterm infants with repeated procedural pain; (2) cortisol level at discharge from the neonatal intensive care unit (NICU); (3) neurobehavioral development at 40 weeks' corrected gestational age; (4"", 'preterm infants']","['sucrose combined with massage, music, non-nutritive sucking and gentle human touch', 'routine care or combined interventions across repeated painful procedures throughout their NICU stay', 'combined pharmacological, behavioral, and physical interventions']","['salivary cortisol and neurobehavioral development', 'basal salivary cortisol level at admission and discharge, neonatal behavioral neurological assessment score', 'pain response, cortisol level and neurobehavioral development', 'cortisol level', 'preterm infant pain profile (PIPP) scores in the early, middle, and late periods of the NICU stay', 'efficacy and safety', 'cortisol levels']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}]","[{'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0240322', 'cui_str': 'Menstrual period late'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",76.0,0.0863337,"Our findings indicated that the combined interventions remained efficacious and safe for reducing repeated procedural pain, decreased the cortisol level at discharge, and promoted early neurobehavioral development in preterm infants.","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Guihua', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': ""Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Rong', 'Affiliation': ""Children's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Mi', 'Affiliation': 'School of Nursing, Nanjing University of Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Children's Hospital of Nanjing Medical University, Nanjing, China.""}]",Pain,['10.1097/j.pain.0000000000002015']
1634,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1635,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1636,32781371,A pragmatic randomised controlled trial of the fostering changes programme.,"BACKGROUND


Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
OBJECTIVE


To determine whether group-based training improves foster carer self-efficacy.
PARTICIPANTS AND SETTING


Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part.
METHODS


The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves.
RESULTS


312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed.
CONCLUSIONS


Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes.",2020,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","['Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks', 'Sixteen local authorities and three independent fostering providers in Wales took part', '312 consented foster carers']","['usual care', 'FC']","['foster carer self-efficacy', 'carer-reported self-efficacy', 'Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves', 'Carer Efficacy Questionnaire']","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.166724,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom, Wales. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: Scourfield@cardiff.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104646']
1637,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE


Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE


To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN


Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING


Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS


103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS


Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES


Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE


ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS


ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1638,32809014,Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial.,"Importance


Cryptogenic sensory polyneuropathy (CSPN) is a common generalized slowly progressive neuropathy, second in prevalence only to diabetic neuropathy. Most patients with CSPN have significant pain. Many medications have been tried for pain reduction in CSPN, including antiepileptics, antidepressants, and sodium channel blockers. There are no comparative studies that identify the most effective medication for pain reduction in CSPN.
Objective


To determine which medication (pregabalin, duloxetine, nortriptyline, or mexiletine) is most effective for reducing neuropathic pain and best tolerated in patients with CSPN.
Design, Setting, and Participants


From December 1, 2014, through October 20, 2017, a bayesian adaptive, open-label randomized clinical comparative effectiveness study of pain in 402 participants with CSPN was conducted at 40 neurology care clinics. The trial included response adaptive randomization. Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain). Participant allocation to 1 of 4 drug groups used the utility function and treatment's sample size for response adaptation randomization. At each interim analysis, a decision was made to continue enrolling (up to 400 participants) or stop the whole trial for success (80% power). Patient engagement was maintained throughout the trial, which helped guide the study and identify ways to communicate and disseminate information. Analysis was performed from December 11, 2015, to January 19, 2018.
Interventions


Participants were randomized to receive nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69).
Main Outcomes and Measures


The primary outcome was a utility function that was a composite of the efficacy (participant reported pain reduction of ≥50% from baseline to week 12) and quit (participants who discontinued medication) rates.
Results


Among the 402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3%]), the utility function of nortriptyline was 0.81 (95% bayesian credible interval [CrI], 0.69-0.93; 34 of 134 [25.4%] efficacious; and 51 of 134 [38.1%] quit), of duloxetine was 0.80 (95% CrI, 0.68-0.92; 29 of 126 [23.0%] efficacious; and 47 of 126 [37.3%] quit), pregabalin was 0.69 (95% CrI, 0.55-0.84; 11 of 73 [15.1%] efficacious; and 31 of 73 [42.5%] quit), and mexiletine was 0.58 (95% CrI, 0.42-0.75; 14 of 69 [20.3%] efficacious; and 40 of 69 [58.0%] quit). The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
Conclusions and Relevance


This study found that, although there was no clearly superior medication, nortriptyline and duloxetine outperformed pregabalin and mexiletine when pain reduction and undesirable adverse effects are combined to a single end point.
Trial Registration


ClinicalTrials.gov Identifier: NCT02260388.",2020,"The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
","['Real Life Situations (PAIN-CONTRoLS', '402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3', 'patients with CSPN', '402 participants with CSPN was conducted at 40 neurology care clinics', 'Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain']","['mexiletine', 'nortriptyline', 'duloxetine', 'pregabalin', 'medication (pregabalin, duloxetine, nortriptyline, or mexiletine']","['neuropathic pain and best tolerated', 'utility function that was a composite of the efficacy (participant reported pain reduction', 'pain reduction and undesirable adverse effects', 'pain']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0271681', 'cui_str': 'Sensory polyneuropathy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",402.0,0.150063,"The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Herbelin', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'Kimminau', 'Affiliation': 'Department of Family Medicine, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Dinesh Pal', 'Initials': 'DP', 'LastName': 'Mudaranthakam', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Jawdat', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Iyadurai', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Stino', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kissel', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pascuzzi', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wicklund', 'Affiliation': 'Pennsylvania State University, Centre County.'}, {'ForeName': 'Aiesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Pennsylvania State University, Centre County.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walk', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado-Denver, Denver.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Tobon', 'Affiliation': 'UT Health Science-San Antonio, San Antonio, Texas.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'Barrow Neurology, Phoenix, Arizona.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida Jacksonville, Jacksonville.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Hayat', 'Affiliation': 'Saint Louis University, St Louis, Missouri.'}, {'ForeName': 'Yuebing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Pariwat', 'Initials': 'P', 'LastName': 'Thaisetthawatkul', 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Suur', 'Initials': 'S', 'LastName': 'Biliciler', 'Affiliation': 'University of Texas Health Science Center at Houston.'}, {'ForeName': 'Khema', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Salajegheh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Trivedi', 'Affiliation': 'UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Mallonee', 'Affiliation': 'Hutchinson Clinic, Hutchinson, Kansas.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Burns', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jacoby', 'Affiliation': 'Mercy Medical Center, Des Moines, Iowa.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida-Tampa, Tampa.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Ramchandren', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bazant', 'Affiliation': 'Norton Neurology Services, Louisville, Kentucky.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Austin', 'Affiliation': 'Seton Brain and Spine, Austin, Texas.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Yessar', 'Initials': 'Y', 'LastName': 'Hussain', 'Affiliation': 'Austin Neuromuscular Center, Austin, Texas.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Kutz', 'Affiliation': 'Colorado Springs Neurological Associates, Colorado Springs.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Twydell', 'Affiliation': 'Spectrum Health, Grand Rapids, Michigan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scelsa', 'Affiliation': 'Mt Sinai Beth Israel, New York, New York.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Kushlaf', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'University of Florida-Gainesville, Gainesville.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hehir', 'Affiliation': 'University of Vermont, Burlington.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kolb', 'Affiliation': 'University of Vermont, Burlington.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Ralph', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Barboi', 'Affiliation': 'NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Neurological Services of Orlando Research, Orlando, Florida.'}, {'ForeName': 'Moiz', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Grand Medical Clinic, Katy, Texas.'}, {'ForeName': 'Anza', 'Initials': 'A', 'LastName': 'Memon', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saperstein', 'Affiliation': 'Phoenix Neurological, Phoenix, Arizona.'}, {'ForeName': 'Jau-Shin', 'Initials': 'JS', 'LastName': 'Lou', 'Affiliation': 'University of North Dakota, Grand Forks.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City.'}, {'ForeName': 'Tiyonnoh', 'Initials': 'T', 'LastName': 'Cash', 'Affiliation': 'University of California-Irvine, Irvine.'}]",JAMA neurology,['10.1001/jamaneurol.2020.2590']
1639,32810739,"The mitochondria-targeted antioxidant MitoQ, attenuates exercise-induced mitochondrial DNA damage.","High-intensity exercise damages mitochondrial DNA (mtDNA) in skeletal muscle. Whether MitoQ - a redox active mitochondrial targeted quinone - can reduce exercise-induced mtDNA damage is unknown. In a double-blind, randomized, placebo-controlled design, twenty-four healthy male participants consisting of two groups (placebo; n = 12, MitoQ; n = 12) performed an exercise trial of 4 x 4-min bouts at 90-95% of heart rate max. Participants completed an acute (20 mg MitoQ or placebo 1-h pre-exercise) and chronic (21 days of supplementation) phase. Blood and skeletal muscle were sampled immediately pre- and post-exercise and analysed for nuclear and mtDNA damage, lipid hydroperoxides, lipid soluble antioxidants, and the ascorbyl free radical. Exercise significantly increased nuclear and mtDNA damage across lymphocytes and muscle (P < 0.05), which was accompanied with changes in lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P < 0.05). Acute MitoQ treatment failed to impact any biomarker likely due to insufficient initial bioavailability. However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05). Our work is the first to show a protective effect of chronic MitoQ supplementation on the mitochondrial and nuclear genomes in lymphocytes and human muscle tissue following exercise, which is important for genome stability.",2020,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","['twenty-four healthy male participants consisting of two groups (placebo; n\xa0=\xa012, MitoQ; n\xa0=\xa012']","['High-intensity exercise damages mitochondrial DNA (mtDNA', 'MitoQ or placebo', 'placebo']","['Blood and skeletal muscle', 'lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P', 'nuclear and mtDNA damage across lymphocytes and muscle (P', 'mtDNA damage in lymphocytes and muscle tissue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",24.0,0.192572,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'Ciara M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': 'Ulster University, Nursing and Health Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cobley', 'Affiliation': 'Free Radical Research Group, University of the Highlands and Islands, Centre for Health Sciences, Inverness, IV2 3JH, UK.'}, {'ForeName': 'Gareth W', 'Initials': 'GW', 'LastName': 'Davison', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK. Electronic address: gw.davison@ulster.ac.uk.'}]",Redox biology,['10.1016/j.redox.2020.101673']
1640,32776237,Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.,"AIMS/HYPOTHESIS


Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT).
METHODS


Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs.
RESULTS


Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years.
CONCLUSIONS/INTERPRETATION


Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention.
TRIAL REGISTRATION


ISRCTN03267836 Graphical abstract.",2020,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","['type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT', 'adults with type 2 diabetes']","['DiRECT)/Counterweight-Plus weight management programme', 'Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet', 'weight management programme']","['life expectancy, quality of life and healthcare costs', 'healthcare costs', 'mean total lifetime cost savings', 'Mean total 2\xa0year healthcare costs', 'Net remission', 'cost per remission', 'Lifetime cost per quality-adjusted life-year (QALY', 'reduced oral glucose-lowering medications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0931155,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","[{'ForeName': 'Yiqiao', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCombie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'C Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Grieve', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wilma S', 'Initials': 'WS', 'LastName': 'Leslie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Translational and Clinical Research Institute, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK. mike.lean@glasgow.ac.uk.'}]",Diabetologia,['10.1007/s00125-020-05224-2']
1641,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
1642,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
1643,32777692,Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.,"OBJECTIVE


To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.
METHODS


We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.
RESULTS


We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.
CONCLUSION


Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.",2020,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","['persons with opioid use disorder seeking treatment', 'persons with opioid use disorder (OUD', 'participants who reported HRQoL beyond baseline']","['naltrexone or buprenorphine-naloxone', 'opioid use disorder pharmacotherapy']",['health-related quality-of-life (HRQoL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",508.0,0.0789426,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. Electronic address: alj4004@med.cornell.edu.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108221']
1644,32781104,A Randomized Phase 2 Study of Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.,"PURPOSE


We evaluated the safety and efficacy of pembrolizumab (pembro) ± radiation therapy (RT) in a phase 2 study among patients with progressive, metastatic adenoid cystic carcinoma (ACC).
METHODS AND MATERIALS


Eligible patients had metastatic ACC with progression within the last year and ≥1 measurable lesion. Patients were randomized to pembro alone or with RT to 30 Gy in 5 fractions (pembroRT). The primary endpoint was objective response rate outside the RT field. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and local RT responses.
RESULTS


We randomized 20 patients (10 per arm) from 2017 to 2018. We did not observe objective response outside of the radiation treatment field; stable disease (SD) was the best response in 12 (60%) patients and was not different per arm (7 pembro, 5 pembroRT, P = .65). A tumor growth rate decrease (TGR) of >25% was noted among 7 of 12 patients and >75% in 4 patients. There were local responses in the irradiated field among all evaluable pembroRT patients. Median PFS and OS were 4.5/not reached for pembroRT and 6.6 / 27.2 months for pembro patients. One patient developed grade 3 liver enzyme elevation after 27 cycles of therapy. Correlative analyses confirm low levels of programmed death-ligand 1 expression (PD-L1), and CD8 infiltrating T-cells. We identified associations between local response and both MYB/NFIB translocation and PD-L1 expression and between changes in systemic immune populations and RT.
CONCLUSIONS


Pembrolizumab and pembroRT were well tolerated. We observed no objective responses, but 60% of patients with PD before the study achieved SD, the majority with decreased TGR and half (n = 10) with clinical benefit (SD >6 months). We observed favorable local responses within the RT field. Additional strategies are needed to further delay progression and effect response.",2020,"Correlative analyses confirm low levels of Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells.","['20 patients (10 per arm) from 2017- 2018', 'patients with progressive, metastatic adenoid cystic carcinoma (ACC', 'patients with recurrent or metastatic adenoid cystic carcinoma', 'Eligible patients had metastatic ACC with progression within the last year and >=1 measurable lesion']","['pembrolizumab (pembro) ', 'pembro alone or with RT to 30 Gray in 5 fractions (pembroRT', 'radiation therapy (RT', 'pembrolizumab with or without radiation']","['Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells', 'Median PFS and OS', 'objective response rate (ORR) outside the RT field', 'grade 3 liver enzyme elevation', 'progression-free survival (PFS), overall survival (OS), and local RT responses', 'safety and efficacy', 'local responses', 'A tumor growth rate (TGR', 'local response and both MYB/NFIB translocation and PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0010606', 'cui_str': 'Adenoid cystic carcinoma'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0026900', 'cui_str': 'myb Oncogene'}, {'cui': 'C1431185', 'cui_str': 'NFIB protein, human'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}]",20.0,0.0272653,"Correlative analyses confirm low levels of Programmed Death-Ligand 1 (PD-L1) expression, and CD8 infiltrating T-cells.","[{'ForeName': 'Umair', 'Initials': 'U', 'LastName': 'Mahmood', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bang', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Mak', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jochen H', 'Initials': 'JH', 'LastName': 'Lorch', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Nishino', 'Affiliation': 'Department of Imaging, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Manuszak', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Thrash', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Severgnini', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sanborn', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Vishwajith', 'Initials': 'V', 'LastName': 'Sridharan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Margalit', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Roy B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Busse', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Willers', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Mamon', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Hyung-Jin', 'Initials': 'HJ', 'LastName': 'Yoo', 'Affiliation': 'Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Sara I', 'Initials': 'SI', 'LastName': 'Pai', 'Affiliation': 'Division of Surgical Oncology, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Wirth', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Nicole G', 'Initials': 'NG', 'LastName': 'Chau', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: jonathan_schoenfeld@dfci.harvard.edu.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.08.018']
1645,32783367,Pregnancy outcome and cost-effectiveness comparisons of artificial cycle-prepared frozen embryo transfer with or without GnRH agonist pretreatment for polycystic ovary syndrome: a randomised controlled trial.,"OBJECTIVE


To compare the live birth rate and cost effectiveness of artificial cycle-prepared frozen embryo transfer (AC-FET) with or without GnRH agonist (GnRH-a) pretreatment for women with polycystic ovary syndrome (PCOS).
DESIGN


Open-label, randomised, controlled trial.
SETTING


Reproductive centre of a university-affiliated hospital.
SAMPLE


A total of 343 women with PCOS, aged 24-40 years, scheduled for AC-FET and receiving no more than two blastocysts.
METHODS


The pretreatment group (n = 172) received GnRH-a pretreatment and the control group (n = 171) did not. Analysis followed the intention-to-treat (ITT) principle.
MAIN OUTCOME MEASURES


The primary outcome measure was live birth rate. Secondary outcome measures included clinical pregnancy rate, implantation rate, early pregnancy loss rate and direct treatment costs per FET cycle.
RESULTS


Among the 343 women randomised, 330 (96.2%) underwent embryo transfer and 328 (95.6%) completed the protocols. Live birth rate according to ITT did not differ between the pretreatment and control groups [85/172 (49.4%) versus 92/171 (53.8%), absolute rate difference -4.4%, 95% CI -10.8% to 2.0% (P = 0.45). Implantation rate, clinical pregnancy rate and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group (7799.2 versus 4438.9 RMB, OR = 1.9, 95%CI 1.2-3.4, P < 0.001). Median direct cost per live birth was also significantly higher in the pretreatment group (15663.1 versus 8189.9 RMB, odds ratio [OR] = 1.9, 95% CI 1.2-3.8, P < 0.001).
CONCLUSIONS


Pretreatment with GnRH-a does not improve pregnancy outcomes for women with PCOS receiving AC-FET, but significantly increases patient cost.
TWEETABLE ABSTRACT


For women with PCOS, artificial cycle-prepared FET with GnRH agonist pretreatment provides no pregnancy outcome benefit but incurs higher cost.",2020,"Implantation rate, clinical pregnancy rate, and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group [7799.2RMB vs. 4438.9 RMB, OR = 1.9, 95%CI: 1.2-3.4, P<0.001].","['343 women with PCOS, aged 24-40 years, scheduled for AC-FET and receiving no more than two blastocysts', 'polycystic ovary syndrome', 'women with polycystic ovary syndrome (PCOS', '343 women randomized, 330 (96.2%) underwent embryo transfer and 328', 'Reproductive center of a university-affiliated hospital']","['GnRH-a pretreatment while the control group', 'artificial cycle-prepared frozen embryo transfer (AC-FET) with or without GnRH agonist (GnRH-a) pretreatment', 'artificial cycle-prepared frozen embryo transfer with or without GnRH agonist pretreatment']","['median direct cost per FET cycle', 'patient cost', 'pregnancy outcomes', 'Median direct cost per live birth', 'live birth rate', 'Implantation rate, clinical pregnancy rate, and early pregnancy loss rate', 'live birth rate and cost effectiveness', 'clinical pregnancy rate, implantation rate, early pregnancy loss rate, and direct treatment costs per FET cycle', 'Live birth rate according to ITT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0643582', 'cui_str': '11-(2-fluoroethyl)estradiol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",343.0,0.258207,"Implantation rate, clinical pregnancy rate, and early pregnancy loss rate also did not differ between groups, but median direct cost per FET cycle was significantly higher in the pretreatment group [7799.2RMB vs. 4438.9 RMB, OR = 1.9, 95%CI: 1.2-3.4, P<0.001].","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wen', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'The Center of Reproductive Medicine, First Affiliated Hospital, Sun Yat-sen University and Guangdong Provincial Key Laboratory of Reproductive Medicine, Guangzhou, China.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16461']
1646,32780921,Effects of monitor alarm management training on nurses' alarm fatigue: A randomised controlled trial.,"BACKGROUND


Chaotic monitor alarm management generates a large number of alarms, which result in alarm fatigue. Intensive care unit (ICU) nurses are caretakers of critically ill patients, the effect of alarm management affect patient safety directly.
OBJECTIVES


To evaluate the effect of monitor alarm management training based on the theory of planned behaviour for reducing alarm fatigue in intensive care unit nurses.
DESIGN


A randomised, single-blind trial. This article follows the requirements of CONSORT statement.
PARTICIPANTS


The study was conducted from February 2019-May 2019 in a tertiary A-level hospital. 93 ICU clinical nurses were included, and they were randomly assigned into two groups.
INTERVENTION


Nurses in the experimental group (n = 47) received a 12-week alarm management training course based on the theory of planned behaviour. Nurses in the control group (n = 46) received regular training. All nurses' alarm fatigue scores were measured with a questionnaire before and after the study period. Total number of alarms, nonactionable alarms and true crisis alarms were recorded continuously throughout the study period.
RESULTS


For baseline comparisons, no significant differences were found. By the analysis of independent samples one-way ANCOVAs, the nurses' adjusted alarm fatigue scores at the post-test in the experimental group were significantly lower than those in the control group (p < .001). After the study period, adjusted total number of alarms and nonactionable alarms recorded in the experimental group were both significantly lower than those recorded in the control group (p < .001). After the study period, no significant difference between the two groups was noted in the adjusted number of true crisis alarms (p > .05). The interventions did not cause adverse events in either group of patients and did not cause adverse events in patients.
CONCLUSION


Intensive care unit nurses' alarm fatigue was effectively decreased by the monitor alarm management training based on the theory of planned behaviour.
RELEVANCE TO CLINICAL PRACTICE


(1) Monitor alarm training based on the theory of planned behaviour is effective in reducing nonactionable alarms and lowering alarm fatigue in ICU nurses. (2) The intervention considering the social psychological aspects of behaviour is effective in rebuilding the nurses' awareness and behaviour of alarm management. (3) Nurses are the direct users of monitoring technology. Hospital administrators should attach importance to the role of nurses in the medical monitoring system. We suggest that nursing managers implement training programmes in more ICUs in the future to improve alarm management ability and lower alarm fatigue in ICU nurses.",2020,Monitor alarm training based on the theory of planned behavior is effective in reducing nonactionable alarms and lowering alarm fatigue in ICU nurses.,"[""Nurses' Alarm Fatigue"", 'ICU nurses are caretakers of critically ill patients', 'The study was conducted from February 2019 to May 2019 in a tertiary A-level hospital', 'Nurses in the experimental group (n = 47', 'intensive care unit nurses', '93 ICU clinical nurses']","['regular training', 'monitor alarm management training', '12-week alarm management training course', 'Monitor Alarm Management Training']","['alarm fatigue scores', 'adjusted number of true crisis alarms', 'Total number of alarms, nonactionable alarms and true crisis alarms', 'adjusted total number of alarms and nonactionable alarms', 'alarm fatigue', ""All nurses' alarm fatigue scores""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0335350', 'cui_str': 'Building caretaker'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",,0.0284062,Monitor alarm training based on the theory of planned behavior is effective in reducing nonactionable alarms and lowering alarm fatigue in ICU nurses.,"[{'ForeName': 'Jiasi', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Nursing Department, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Nursing Department, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Nursing Department, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Ruitong', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Nursing School of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Gastric Department, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Tangsheng', 'Initials': 'T', 'LastName': 'Zhong', 'Affiliation': 'Nursing Department, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zan', 'Affiliation': 'Intensive Care Unit, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Baoxing', 'Initials': 'B', 'LastName': 'Guan', 'Affiliation': 'Intensive Care Unit, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Nursing Department, The First Bethune Hospital of Jilin University, Changchun City, Jilin Province, China.'}]",Journal of clinical nursing,['10.1111/jocn.15452']
1647,32780926,Effects of intraoperative dexmedetomidine on the incidence of acute kidney injury in pediatric cardiac surgery patients: A randomized controlled trial.,"BACKGROUND


Perioperative dexmedetomidine use has been reported to reduce the incidence of postoperative acute kidney injury after adult cardiac surgery. However, large-scale randomized controlled trials evaluating the effect of dexmedetomidine use on acute kidney injury in pediatric patients are lacking.
AIMS


We investigated whether intraoperative dexmedetomidine could reduce the incidence of acute kidney injury in pediatric cardiac surgery patients.
METHODS


In total, 141 pediatric patients were randomly assigned to dexmedetomidine or control groups. After anesthetic induction, patients in the dexmedetomidine group were administered 1 µg/kg of dexmedetomidine over 10 minutes and an additional 0.5 µg/kg/h of dexmedetomidine during surgery. Additionally, 1 µg/kg of dexmedetomidine was infused immediately after cardiopulmonary bypass was initiated. The incidence of acute kidney injury was defined following Kidney Disease Improving Global Outcomes guidelines.
RESULTS


The final analysis included 139 patients. The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; P = .33). Similarly, neither the incidence of abnormal postoperative estimated glomerular filtration rate values (P = .96) nor the incidence of arrhythmia, mechanical ventilation duration, length of stay in the intensive care unit, and hospitalization differed between the two groups.
CONCLUSIONS


Intraoperative dexmedetomidine did not reduce acute kidney injury incidence in pediatric cardiac surgery patients.",2020,The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33).,"['141 pediatric patients', 'pediatric patients', 'pediatric cardiac surgery patients', 'acute kidney injuryin pediatric cardiac surgery patients', '139 patients']","['intraoperativedexmedetomidine', 'dexmedetomidine', 'intraoperative dexmedetomidine']","['acute kidney injuryincidence', 'incidence of abnormal postoperative estimated glomerular filtration ratevalues', 'northe incidence of arrhythmia, mechanical ventilation duration, length of stay in the intensive care unit,and hospitalization', 'incidence of acute kidney injury']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]",141.0,0.5822,The incidence of acute kidney injury did not differ between dexmedetomidine and control groups (16.9% vs. 23.5%; odds ratio 0.661; 95% CI 0.285 to 1.525; p = 0.33).,"[{'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Woong-Han', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiothoracic Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Gun', 'Initials': 'JG', 'LastName': 'Kwak', 'Affiliation': 'Department of Cardiothoracic Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.'}]",Paediatric anaesthesia,['10.1111/pan.13995']
1648,32787978,Study protocol on Enhanced Primary Healthcare (EnPHC) interventions: a quasi-experimental controlled study on diabetes and hypertension management in primary healthcare clinics.,"AIM


This paper describes the study protocol, which aims to evaluate the effectiveness of a multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC) on the process of care and intermediate clinical outcomes among patients with Type 2 diabetes mellitus (T2DM) and hypertension. Other outcome measures include patients' experience and healthcare providers' job satisfaction.
BACKGROUND


In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia. An analysis of health system performance from 2016 to 2018 revealed that the control and management of diabetes and hypertension in Malaysia was suboptimal with almost half of the patients not diagnosed and just one-quarter of patients with diabetes appropriately treated. EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
METHODS


This is a quasi-experimental controlled study which involves 20 intervention and 20 control clinics in two different states in Malaysia, namely Johor and Selangor. The clinics in the two states were matched and randomly allocated to 'intervention' and 'control' arms. The EnPHC framework targets different levels from community to primary healthcare clinics and integrated referral networks.Data are collected via a retrospective chart review (RCR), patient exit survey, healthcare provider survey and an intervention checklist. The data collected are entered into tablet computers which have installed in them an offline survey application. Interrupted time series and difference-in-differences (DiD) analyses will be conducted to report outcomes.",2020,"EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
","['diabetes and hypertension management in primary healthcare clinics', '20 control clinics in two different states in Malaysia, namely Johor and Selangor', 'diagnosed patients', ""In 2014, almost two-thirds of Malaysia's adult population aged 18 years or older had T2DM, hypertension or hypercholesterolaemia"", 'patients with Type 2 diabetes mellitus (T2DM) and hypertension']","[""multifaceted intervention package called 'Enhanced Primary Healthcare' (EnPHC""]","[""patients' experience and healthcare providers' job satisfaction""]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",,0.0247709,"EnPHC framework aims to improve diagnosis and effective management of T2DM, hypertension or hypercholesterolaemia and their risk factors by increasing prevention, optimising management and improving surveillance of diagnosed patients.
","[{'ForeName': 'Sheamini', 'Initials': 'S', 'LastName': 'Sivasampu', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Xin Rou', 'Initials': 'XR', 'LastName': 'Teh', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Yvonne Mei Fong', 'Initials': 'YMF', 'LastName': 'Lim', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Su Miin', 'Initials': 'SM', 'LastName': 'Ong', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Swee Hung', 'Initials': 'SH', 'LastName': 'Ang', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Masliyana', 'Initials': 'M', 'LastName': 'Husin', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Noraziani', 'Initials': 'N', 'LastName': 'Khamis', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Faeiz Syezri Adzmin', 'Initials': 'FSA', 'LastName': 'Jaafar', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Wen Jun', 'Initials': 'WJ', 'LastName': 'Wong', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Shanmugam', 'Affiliation': 'Institute for Health Management, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Siti Aminah', 'Initials': 'SA', 'LastName': 'Ismail', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Sarah Hui Li', 'Initials': 'SHL', 'LastName': 'Pang', 'Affiliation': 'Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia, Selangor, Malaysia.'}, {'ForeName': 'Nazrila Hairizan', 'Initials': 'NH', 'LastName': 'Nasir', 'Affiliation': 'Family Health Development Division, Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Mohd Safiee', 'Initials': 'MS', 'LastName': 'Ismail', 'Affiliation': 'Family Health Development Division, Ministry of Health Malaysia, Putrajaya, Malaysia.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Kusuma', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ross-Degnan', 'Affiliation': 'Harvard Medical School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Rifat', 'Initials': 'R', 'LastName': 'Atun', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Primary health care research & development,['10.1017/S1463423620000250']
1649,32789505,Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials.,"Importance


A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective


To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions


In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants


Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.
Main Outcomes and Measures


The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Results


Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.
Conclusions and Relevance


In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration


Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.",2020,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","['China', '96 participants', '224 adults', 'Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years', '320 patients who were randomized (mean age, 42.8 years; 200 women [62.5']","['aluminum hydroxide (alum) adjuvant-only group', 'investigational inactivated whole-virus COVID-19 vaccine', 'Inactivated Vaccine Against SARS-CoV-2', 'placebo']","['serious adverse reactions', 'antibody responses', 'geometric mean titers of neutralizing antibodies', 'Safety and Immunogenicity Outcomes', 'safety and immunogenicity', 'plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', '7-day adverse reactions', 'neutralizing antibody response']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",224.0,0.329137,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Dongyang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Zhengli', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Lianghao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}]",JAMA,['10.1001/jama.2020.15543']
1650,32789996,Dupilumab significantly improves sleep outcomes in adult patients with atopic dermatitis: results from five randomized clinical trials.,,2020,"Sleep disturbances are part of a symptom triad, along with itch and pain, that patients with atopic dermatitis (AD) report as being frequent and burdensome.","['patients with atopic dermatitis (AD', 'Adult Patients with Atopic Dermatitis', 'adults with chronic AD']","['placebo', 'Dupilumab', 'dupilumab']","['Sleep Outcomes', 'Sleep disturbances']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",3.0,0.193735,"Sleep disturbances are part of a symptom triad, along with itch and pain, that patients with atopic dermatitis (AD) report as being frequent and burdensome.","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Yosipovitch', 'Affiliation': 'Miami Itch Center, Dr Phillip Frost Department of Dermatology & Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Guillemin', 'Affiliation': 'Sanofi, Lyon, France.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Plaum', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16865']
1651,32785881,Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA ≥ 3: Post-Hoc Analysis From Three Randomized Controlled Trials.,"INTRODUCTION


Psoriasis is a chronic, inflammatory disease, which ranges in severity from mild to severe. Although topical therapies are frequently used to treat mild disease, they are not routinely used to treat patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥ 5% BSA). Based on well-controlled trials in adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg/g + betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (Enstilar®, LEO Pharma) in the USA and EU for the treatment of psoriasis vulgaris for up to 4 weeks in adults. In this post-hoc subgroup analysis, we used pooled data from phase II/III trials to investigate the efficacy and safety of Cal/BD cutaneous foam in patients with moderate-to-severe psoriasis.
METHODS


Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA) ≥ 3. Endpoints included: treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety.
RESULTS


A total of 340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam. Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam. Sixty-six adverse events (AEs) occurred in 47 (18.5%) patients receiving Cal/BD foam and 11 AEs occurred in 11 (12.8%) patients receiving vehicle foam. Three severe AEs and 15 non-serious treatment-related AEs occurred in patients receiving Cal/BD foam.
CONCLUSION


The results from three clinical trials analyzed together show that topical Cal/BD foam is well tolerated and efficacious for treating patients with moderate-to-severe disease. Data support Cal/BD foam as a potential topical therapy for moderate-to-severe psoriasis.
TRIAL REGISTRATIONS


ClinicalTrials.gov registration numbers: NCT01866163, NCT02132936, NCT01536886.",2020,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[""Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA)\u2009≥\u20093"", '340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam', 'adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 μg', 'patients with moderate-to-severe psoriasis', 'Psoriasis in Patients With BSA 5-15% and PGA\u2009≥\u20093', 'patients with moderate-to-severe disease', 'patients with moderate-to-severe disease who have a larger proportion of their body surface area (BSA) affected (≥\u20095% BSA']","['g + betamethasone dipropionate 0.5', 'Calcipotriol/Betamethasone Dipropionate Cutaneous Foam']","[""treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety"", 'tolerated and efficacious']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3653162', 'cui_str': 'calcipotriol, combinations'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C1160727', 'cui_str': 'Cutaneous foam'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",340.0,0.163511,"Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam.","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Iversen', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark. lars.iversen@clin.au.dk.'}, {'ForeName': 'Merle', 'Initials': 'M', 'LastName': 'Kurvits', 'Affiliation': 'Biostatistics Department, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Anja Marieke', 'Initials': 'AM', 'LastName': 'Snel-Prentø', 'Affiliation': 'Global Medical Affairs, LEO Pharma, Ballerup, Denmark.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White Health, Dallas, TX, USA.'}]",Dermatology and therapy,['10.1007/s13555-020-00419-2']
1652,32814120,Development and preliminary testing of a technology-enhanced intervention to improve energy intake regulation in children.,"Interventions designed to improve children's self-regulation of energy intake have yielded mixed results. We tested the efficacy of a technology-enhanced intervention designed to teach children to eat in response to internal hunger and fullness cues. Thirty-two children (mean age 4.9 ± 0.8 y) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions, each scheduled approximately 1 week apart. The intervention was conducted across weeks 4-7 in small groups focused on teaching children how food travels through the body and how to respond to hunger and fullness signals. Children's short-term energy compensation, a measure of intake regulation, was collected at baseline and follow-up using a preloading protocol. Twenty-five minutes prior to receiving a standardized test meal, children consumed a low-energy (3 kcal) or high-energy (150 kcal) preload beverage, presented in random order at baseline and follow-up. Knowledge of intervention concepts was also assessed at baseline and follow-up. Linear mixed models were used to examine changes in short-term energy compensation and knowledge from baseline to follow-up. Knowledge related to the intervention improved from baseline to follow-up (3.5 ± 0.3 to 7.0 ± 0.3 correct responses out of a possible 10; P < 0.001). Children's energy compensation also improved from baseline to follow-up, as evidenced by a time-by-preload condition interaction (P = 0.02). However, this improvement was driven by boys who increased the adjustment for beverage energy content from baseline to follow-up (P = 0.04). Girls showed no change in energy compensation with the intervention (P = 0.58). The overall increase in knowledge, paired with the improvement in energy compensation in boys, suggests that this technology-enhanced intervention may be efficacious for some children. Further research is needed to determine whether boys and girls will benefit from different, personalized intervention strategies for obesity prevention.",2020,Girls showed no change in energy compensation with the intervention (P = 0.58).,"['Thirty-two children (mean age 4.9\u202f±\u202f0.8\u202fy) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions', 'children']","['technology-enhanced intervention', 'standardized test meal, children consumed a low-energy (3\u202fkcal) or high-energy (150\u202fkcal) preload beverage']","['energy compensation', ""Children's energy compensation""]","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",32.0,0.0189846,Girls showed no change in energy compensation with the intervention (P = 0.58).,"[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 226 Henderson Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'The Pennsylvania State University, Center for Childhood Obesity Research and Department of Nutritional Sciences. 129 Noll Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Department of Pediatrics. 12631 East 17th Avenue, Mail Stop F-561, Academic Office Building, Room 2609; Aurora, CO, 80045, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'The Pennsylvania State University, Departments of Nutritional Sciences and Food Science. 321 Chandlee Laboratory, University Park, PA, 16802, USA. Electronic address: klk37@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.104830']
1653,32815423,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.,"Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data from two clinical studies with the first oral GLP-1RA, oral semaglutide, in situations where injectable therapy is often considered, and provides guidance on use in primary care. PIONEER 4 compared oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo in patients uncontrolled on oral glucose-lowering therapies. PIONEER 8 compared oral semaglutide with placebo in patients with T2D already on insulin therapy. Treatment with oral semaglutide gave similar reductions in glycated hemoglobin (HbA 1   c ) compared with liraglutide at 26 weeks, and significantly greater reductions at 52 weeks. Changes in body weight with oral semaglutide were significantly greater compared with liraglutide after 26 and 52 weeks. Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1   c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage. Oral semaglutide was associated with low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia when added to oral glucose-lowering therapies, and did not increase the incidence of such events when added to insulin. The tolerability profile of oral semaglutide was consistent with that seen for injectable GLP-1RAs, with gastrointestinal side effects seen most frequently; most were transient and tended to occur during dose escalation. For patients requiring treatment intensification after oral therapy or as add-on to insulin, oral semaglutide provides effective glucose lowering and body weight loss, with low risk of hypoglycemia, thus broadening the range of therapeutic options for treatment of T2D in primary care.",2020,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","['people with type 2 diabetes (T2D) who require treatment intensification', 'patients with T2D already on insulin therapy', 'patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy', 'patients uncontrolled on oral glucose-lowering therapies']","['liraglutide', 'oral semaglutide', 'oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo', 'glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin', 'placebo']","['HbA 1c  and body weight', 'body weight with oral semaglutide', 'total daily insulin dosage', 'body weight loss', 'low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia', 'glycated hemoglobin (HbA 1c ', 'tolerability profile of oral semaglutide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0294087,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","[{'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Wright', 'Affiliation': 'Charlotte Area Health Education Center , Charlotte, NC, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital; Harvard Medical School , Boston, MA, USA.""}]",Postgraduate medicine,['10.1080/00325481.2020.1798127']
1654,32816177,Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation.,"During one-lung ventilation (OLV), titrating the positive end-expiratory pressure (PEEP) to target a low driving pressure (∆P) could reduce postoperative pulmonary complications. However, it is unclear how to conduct PEEP titration: by stepwise increase starting from zero PEEP (PEEP INCREMENTAL ) or by stepwise decrease after a lung recruiting manoeuvre (PEEP DECREMENTAL ). In this randomized trial, we compared the physiological effects of these two PEEP titration strategies on respiratory mechanics, ventilation/perfusion mismatch and gas exchange. Patients undergoing video-assisted thoracoscopic surgery in OLV were randomly assigned to a PEEP INCREMENTAL  or PEEP DECREMENTAL  strategy to match the lowest ∆P. In the PEEP INCREMENTAL  group, PEEP was stepwise titrated from ZEEP up to 16 cm H 2 O, whereas in the PEEP DECREMENTAL  group PEEP was decrementally titrated, starting from 16 cm H 2 O, immediately after a lung recruiting manoeuvre. Respiratory mechanics, ventilation/perfusion mismatch and blood gas analyses were recorded at baseline, after PEEP titration and at the end of surgery. Sixty patients were included in the study. After PEEP titration, shunt decreased similarly in both groups, from 50 [39-55]% to 35 [28-42]% in the PEEP INCREMENTAL  and from 45 [37-58]% to 33 [25-45]% in the PEEP DECREMENTAL  group (both p < 0.001 vs baseline). The resulting ∆P, however, was lower in the PEEP DECREMENTAL  than in the PEEP INCREMENTAL  group (8 [7-11] vs 10 [9-11] cm H 2 O; p = 0.03). In the PEEP DECREMENTAL  group the PaO 2 / FIO 2  ratio increased significantly after intervention (from 140 [99-176] to 186 [152-243], p < 0.001). Both the PEEP INCREMENTAL  and the PEEP DECREMENTAL  strategies were able to decrease intraoperative shunt, but only PEEP DECREMENTAL  improved oxygenation and lowered intraoperative ΔP.Clinical trial number NCT03635281; August 2018; ""retrospectively registered"".",2020,"Both the PEEP INCREMENTAL  and the PEEP DECREMENTAL  strategies were able to decrease intraoperative shunt, but only PEEP DECREMENTAL  improved oxygenation and lowered intraoperative ΔP.Clinical trial number NCT03635281; August 2018; ""retrospectively registered"".","['Patients undergoing video-assisted thoracoscopic surgery in OLV', 'Sixty patients were included in the study']","['two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation', 'PEEP INCREMENTAL  or PEEP DECREMENTAL  strategy to match the lowest ∆P', 'lung ventilation (OLV), titrating the positive end-expiratory pressure (PEEP) to target a low driving pressure (∆P']","['respiratory mechanics, ventilation/perfusion mismatch and gas exchange', 'Respiratory mechanics, ventilation/perfusion mismatch and blood gas analyses', 'postoperative pulmonary complications', 'PaO 2 / FIO 2  ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",60.0,0.173319,"Both the PEEP INCREMENTAL  and the PEEP DECREMENTAL  strategies were able to decrease intraoperative shunt, but only PEEP DECREMENTAL  improved oxygenation and lowered intraoperative ΔP.Clinical trial number NCT03635281; August 2018; ""retrospectively registered"".","[{'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy. savinospadaro@gmail.com.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grasso', 'Affiliation': 'Department of Emergency and Organ Transplant (DETO), ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Dan Stieper', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Santoro', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cavallesco', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Thoracic Surgery, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Maniscalco', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Thoracic Surgery, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Murgolo', 'Affiliation': 'Department of Emergency and Organ Transplant (DETO), ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Di Mussi', 'Affiliation': 'Department of Emergency and Organ Transplant (DETO), ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Ragazzi', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}, {'ForeName': 'Stephen Edward', 'Initials': 'SE', 'LastName': 'Rees', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Volta', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fogagnolo', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00582-z']
1655,32818525,A direct comparison of the electrophysiological effects of transcranial direct and alternating current stimulation in healthy subjects.,"OBJECTIVE


Despite the clinical effectiveness of transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), the comparability of these interventions in neurophysiological aspects have not been thoroughly investigated. Thus, we aimed to directly compare the electrophysiological effects of single-session tDCS and gamma-tACS in healthy subjects, matching the intervention protocol as closely as possible.
METHODS


This was a randomized, double-blinded, and active-controlled study. Sixty healthy college students were enrolled in the study. Both tACS with, at 40 Hz frequency, and tDCS have the same current intensity (2 mA, 30 min) within the same target area (right and left dorsolateral prefrontal cortex). Resting-state electroencephalography (EEG) was recorded before and after single-session stimulation.
RESULTS


Significant differences in theta, alpha, low-beta, and gamma frequencies were found between tDCS, tACS, and the sham groups. Low-beta source activity of the middle temporal gyrus was decreased only after an intervention with tACS.
CONCLUSION


The present study indicates that tDCS and tACS resulted in an increased range of frequency activity, including slow- and fast-wave bands. Specifically, tDCS modulates the frontal region, while tACS modulates neural oscillations at the fronto-central, parietal, and temporal areas. The tACS also decreased low-beta source activity in the middle temporal gyrus. Identifying the common and unique EEG patterns of tDCS and tACS may help shed light on their potential clinical benefits and distinctive neuropathology in various clinical symptoms.",2020,"RESULTS


Significant differences in theta, alpha, low-beta, and gamma frequencies were found between tDCS, tACS, and the sham groups.","['healthy subjects', 'Sixty healthy college students']","['tDCS and tACS', 'transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS', 'single-session tDCS and gamma-tACS', 'transcranial direct and alternating current stimulation']","['Low-beta source activity', 'range of frequency activity', 'theta, alpha, low-beta, and gamma frequencies', 'low-beta source activity', 'Resting-state electroencephalography (EEG']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0442830', 'cui_str': 'Alternating current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",60.0,0.0531433,"RESULTS


Significant differences in theta, alpha, low-beta, and gamma frequencies were found between tDCS, tACS, and the sham groups.","[{'ForeName': 'Jiheon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea; Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Kuk-In', 'Initials': 'KI', 'LastName': 'Jang', 'Affiliation': 'Department of Cognitive Science Research, Korea Brain Research Institute, Daegu, Republic of Korea.'}, {'ForeName': 'Daeyoung', 'Initials': 'D', 'LastName': 'Roh', 'Affiliation': 'Department of Psychiatry, Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea; Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Hansol', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea; Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea. Electronic address: dohkim@hallym.ac.kr.'}]",Brain research,['10.1016/j.brainres.2020.147065']
1656,32819191,A pilot study investigating the impact of a caffeine-nap on alertness during a simulated night shift.,"Consuming coffee immediately prior to a nap, known as a caffeine-nap, has been shown to improve alertness during the day, but it is unknown whether a caffeine-nap is effective at reducing sleep inertia during the night. A simulated shiftwork cross-over laboratory study was conducted whereby participants (N = 6, 4 F, 21-36y) consumed 200 mg of caffeine, or decaffeinated coffee (placebo), immediately prior to a 30 min nap opportunity at 03:30 h. Compared to placebo, the caffeine-nap resulted in improved vigilant attention and subjective fatigue in the 45 min post-nap opportunity. The caffeine-nap may be useful in reducing sleep inertia in shift workers who nap on nightshift.",2020,"Compared to placebo, the caffeine-nap resulted in improved vigilant attention and subjective fatigue in the 45 min post-nap opportunity.","['participants (N\xa0=\xa06, 4\xa0F, 21-36y) consumed 200 mg of']","['caffeine, or decaffeinated coffee (placebo', 'caffeine-nap', 'placebo']","['vigilant attention and subjective fatigue', 'sleep inertia']","[{'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]","[{'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1963765', 'cui_str': 'Sleep inertia'}]",,0.02922,"Compared to placebo, the caffeine-nap resulted in improved vigilant attention and subjective fatigue in the 45 min post-nap opportunity.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Centofanti', 'Affiliation': 'UniSA Online, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Coussens', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Gray', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Munro', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Johnathon', 'Initials': 'J', 'LastName': 'Nielsen', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Dorrian', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}]",Chronobiology international,['10.1080/07420528.2020.1804922']
1657,32819928,ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.,"INTRODUCTION


Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
METHODS AND ANALYSIS


We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent-child interactions to improve early social reciprocity, while supporting parental mental health and the parent-child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent-infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.
ETHICS AND DISSEMINATION


This protocol has been approved by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).",2020,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","['infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD', 'infants at risk of autism spectrum disorder', 'Autism spectrum disorder (ASD', '66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT']","['ENACT (ENvironmental enrichment', 'innovative intervention', 'ENACT', 'social reciprocity intervention']","['parent-infant interaction, parental mental health, infant development and early ASD markers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.264507,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia koawhittingham@uq.edu.au.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McGlade', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kavindri', 'Initials': 'K', 'LastName': 'Kulasinghe', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mitchell', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Honey', 'Initials': 'H', 'LastName': 'Heussler', 'Affiliation': 'Mater Medical Research Institute, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034315']
1658,32783585,Small and large cutaneous fibers display different excitability properties to slowly increasing ramp pulses.,"The excitability of large nerve fibers is reduced when their membrane potential is slowly depolarizing, i.e., the fibers display accommodation. The aim of this study was to assess accommodation in small (mainly Aδ) and large (Aβ) cutaneous sensory nerve fibers using the perception threshold tracking (PTT) technique. Linearly increasing ramp currents (1 ms-200 ms) were used to assess the excitability of the nerve fibers by cutaneous electrical stimulation. To investigate the PPT technique's ability to preferentially activate different fiber types, topical application of lidocaine/prilocaine (EMLA) or a placebo cream was applied. By means of computational modeling, the underlying mechanisms governing the perception threshold in the two fiber types was studied. The axon models included the voltage-gated ion channels: transient TTX-sensitive sodium current, transient TTX-resistant sodium current (Na TTXr ), persistent sodium current, delayed rectifier potassium channel (K Dr ), slow potassium channel, and hyperpolarization-activated current. Large fibers displayed accommodation, whereas small fibers did not display accommodation ( P  < 0.05). For the pin electrode, a significant interaction was observed between cream (EMLA or placebo) and pulse duration ( P  < 0.05); for the patch electrode, there was no significant interaction between cream and duration, which supports the pin electrode's preferential activation of small fibers. The results from the computational model suggested that differences in accommodation between the two fiber types may originate from selective expression of voltage-gated ion channels, particularly the transient Na TTXr  and/or K Dr . The PTT technique could assess the excitability changes during accommodation in different nerve fibers. Therefore, the PTT technique may be a useful tool for studying excitability in nerve fibers in both healthy and pathological conditions. NEW & NOTEWORTHY  When large nerve fibers are stimulated by long, slowly increasing electrical pulses, interactive mechanisms counteract the stimulation, which is called accommodation. The perception threshold tracking technique was able to assess accommodation in both small and large fibers. The novelty of this study is that large fibers displayed accommodation, whereas small fibers did not. Additionally, the difference in accommodation between the fiber could be linked to expression of voltage-gated ion channels by means of computational modeling.",2020,"Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05).",[],"['placebo cream', 'lidocaine/prilocaine (EMLA', 'cream (EMLA or placebo', 'perception threshold tracking (PTT) technique']",['excitability changes'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0246953,"Large fibers displayed accommodation, whereas small fibers did not display accommodation (p<0.05).","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Tigerholm', 'Affiliation': 'Integrative Neuroscience Group, Center for Neuroplasticity and Pain (CNAP), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Tatiana Nielson', 'Initials': 'TN', 'LastName': 'Hoberg', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Brønnum', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Vittinghus', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Ken Steffen', 'Initials': 'KS', 'LastName': 'Frahm', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Carsten Dahl', 'Initials': 'CD', 'LastName': 'Mørch', 'Affiliation': 'Center for Sensory-Motor Interaction (SMI), Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}]",Journal of neurophysiology,['10.1152/jn.00629.2019']
1659,32785986,The efficacy of microneedling alone vs its combination with 5-fluorouracil solution vs 5-fluorouracil intralesional injection in the treatment of plantar warts.,"Intralesional 5-fluorouracil (IL5-FU) has been used off-label for warts treatment; however, its use was limited by intense pain. Combination treatment can offer a robust therapeutic effect. Was to assess the therapeutic efficacy, safety and tolerability of microneedling vs its combination with 5-FU solution vs IL5-FU in the treatment of plantar warts. Ninety patients with plantar warts were divided randomly into three groups each containing 30 patients. Group A received (intralesional 5-FU), group B (microneedling) while group C (microneedling and 5-FU solution). All groups received treatment for a maximum of six sessions 2 weeks apart. Complete response was observed in 86.7% of the warts treated with 5-FU and microneedling (group C) vs to 76.7% and 70% in group A and B, respectively, with no statistically significant difference (P = .36). A significant increase in the number of sessions (P = .01) and pain score (P = .001) were found among group A compared to groups B and C. Patient's satisfaction was higher in group C (P = .05). No recurrence was reported in all groups. Microneedling can be used as alternative or adjuvant therapeutic modality for plantar warts treatment and significantly associated with less pain. Combination group was superior compared to the others.",2020,"A significant increase in the number of sessions (P = 0.01) and pain score (P = 0.001) were found among group A compared to groups B and C. Patient's satisfaction was higher in group C (P = 0.05).No recurrence was reported in all groups.
","['Plantar Warts', 'plantar warts', 'Ninety Patients with plantar warts']","['5-FU solution vs IL5-FU', 'microneedling alone vs its combination with 5- Fluorouracil Solution vs 5-Fluorouracil intralesional injection', '5-FU', 'intralesional 5-FU), group B (microneedling) while group C (microneedling and 5-FU solution', 'Intralesional 5- fluorouracil (IL5-FU']","['number of sessions', 'pain score', 'therapeutic efficacy, safety and tolerability', 'pain']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",90.0,0.0172998,"A significant increase in the number of sessions (P = 0.01) and pain score (P = 0.001) were found among group A compared to groups B and C. Patient's satisfaction was higher in group C (P = 0.05).No recurrence was reported in all groups.
","[{'ForeName': 'Soheir', 'Initials': 'S', 'LastName': 'Ghonemy', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Mahitab', 'Initials': 'M', 'LastName': 'Ibrahim Ali', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Howyda Mohamed', 'Initials': 'HM', 'LastName': 'Ebrahim', 'Affiliation': 'Faculty of Medicine, Department of Dermatology, Zagazig University, Zagazig, Egypt.'}]",Dermatologic therapy,['10.1111/dth.14179']
1660,32790921,Histological and histomorphometrical outcome after lateral guided bone regeneration augmentation of the mandible with different ratios of deproteinized bovine bone mineral and autogenous bone. A preclinical in vivo study.,"OBJECTIVE


To test the hypotheses of no differences in (I) percentage of bone (POB), non-mineralized tissue (NMT), and deproteinized bovine bone mineral (DBBM), and (II) ingrowth of mineralized bone after lateral guided bone regeneration (GBR) augmentation of the mandible with different ratios of DBBM and particulate autogenous bone (PAB) at different time points.
MATERIAL AND METHODS


Twenty-four minipigs were randomly allocated into three groups. Lateral augmentation in 96 sites (4 in each animal) was performed unilaterally with a standardized quantity of grafting material in each animal with different ratios of DBBM and PAB (50:50, 75:25, 100:0) and autogenous bone block in combination with DBBM and covered with a collagen membrane. The percentage of different tissues in the graft and ingrowth of mineralized bone was assessed by histomorphometrical and histological analyses after 10, 20, and 30 weeks, respectively.
RESULTS


The POB was 54% (50:50), 50% (75:25), and 48% (100:0) after 10 weeks, 60% (50:50), 61% (75:25), and 60% (100:0) after 20 weeks, and 63% (50:50), 62% (75:25), and 62% (100:0) after 30 weeks. There was no significant difference between the groups at any time points. There was a significant increase in POB and a significant decrease in NMT for 75:25 and 100:0 from 10 to 30 weeks. All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
CONCLUSION


Within the limitations of the present study, it seems like addition of autogenous bone to DBBM for LRA did not affect the bone formation nor graft incorporation after 10-30 weeks of healing. However, a prolonged healing time seems to result in an increased POB for all ratios.",2020,"All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
",['Twenty-four minipigs'],"['autogenous bone block in combination with DBBM and covered with a collagen membrane', 'deproteinized bovine bone mineral and autogenous bone']","['bone formation nor graft incorporation', 'bone (POB), non-mineralized tissue (NMT) and deproteinized bovine bone mineral (DBBM), and (II) ingrowth of mineralized bone', 'POB', 'NMT']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0039011', 'cui_str': 'Miniature Swine'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}]","[{'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}]",24.0,0.0558712,"All ratios demonstrated a non-complete ingrowth of mineralized bone into the graft after 10 weeks and complete mineralization after 30 weeks.
","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Aludden', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Mordenfeld', 'Affiliation': 'Plastic and Oral & Maxillofacial Surgery, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Dahlin', 'Affiliation': 'Department of Biomaterials, BIOMATCELL VINN Excellence center, Institute for Surgical Science, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Gävle County Hospital, Gävle, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Starch-Jensen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Aalborg University Hospital, Aalborg, Denmark.'}]",Clinical oral implants research,['10.1111/clr.13649']
1661,32791030,Examining HSD3B1 as a possible biomarker to detect prostate cancer patients who are likely to progress on ADT.,The Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a randomized phase III trial that evaluated the outcomes of men with metastatic prostate cancer who received castration with or without docetaxel. Patients from this trial were genotyped in a recent study to detect HSD3B1 variance and to determine 2-y freedom from castration-resistant prostate cancer as well as overall survival. The results of this study identified HSD3B1 as a possible biomarker that can be used to predict response to therapy in patients with metastatic disease.,2020,The Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a randomized phase III trial that evaluated the outcomes of men with metastatic prostate cancer who received castration with or without docetaxel.,"['patients with metastatic disease', 'men with metastatic prostate cancer who received', 'prostate cancer patients who are likely to progress on ADT']",['castration with or without docetaxel'],['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.034008,The Chemohormonal Therapy vs Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) was a randomized phase III trial that evaluated the outcomes of men with metastatic prostate cancer who received castration with or without docetaxel.,"[{'ForeName': 'Whitney F', 'Initials': 'WF', 'LastName': 'Handy', 'Affiliation': 'Bernard J. Dunn School of Pharmacy, Shenandoah University , Fairfax, VA, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Schmidt', 'Affiliation': 'Clinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Price', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Figg', 'Affiliation': 'Clinical Pharmacology Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA.'}]",Cancer biology & therapy,['10.1080/15384047.2020.1796195']
1662,32792635,Early use of combined exogenous surfactant and inhaled nitric oxide reduces treatment failure in persistent pulmonary hypertension of the newborn: a randomized controlled trial.,"OBJECTIVE


To evaluate whether combined surfactant with inhaled nitric oxide (iNO) use will prevent newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI) > 40.
METHODS


100 term newborns with acute HRF (OI ≥ 20) were randomized to: Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo. Main outcome was the development of severe HRF (OI > 40) despite iNO use.
RESULTS


Baseline mean ± SD OI was 37.4 ± 14 for the Surfactant+iNO group and 38.2 ± 16 for the controls. Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02. Fewer infants receiving surfactant+iNO presented the combined outcome of death or ECMO: 16%(8/50) compared to 36%(18/50) of controls, p < 0.05.
CONCLUSIONS


Early use of combined surfactant+iNO improves oxygenation preventing the progression to severe HRF. This may reduce mortality and ECMO need.
TRIAL REGISTRATION NUMBER


ISRCTN13727958.",2020,"Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02.","['newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI)\u2009>\u200940', 'persistent pulmonary hypertension of the newborn', '100 term newborns with acute HRF (OI\u2009≥\u200920']","['combined surfactant with inhaled nitric oxide (iNO', 'combined exogenous surfactant and inhaled nitric oxide', 'Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo']","['death or ECMO', 'development of severe HRF (OI\u2009>\u200940) despite iNO use', 'oxygenation faster']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0031190', 'cui_str': 'Persistent pulmonary hypertension of the newborn'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",100.0,0.237933,"Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02.","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile. alvgonza@med.puc.cl.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Bancalari', 'Affiliation': 'Hospital Guillermo Grant Benavente and Department of Pediatrics, Faculty of Medicine, Universidad de Concepción, Concepción, Chile.'}, {'ForeName': 'Waldo', 'Initials': 'W', 'LastName': 'Osorio', 'Affiliation': 'Hospital Luis Tisné, Santiago, Chile.'}, {'ForeName': 'Matías', 'Initials': 'M', 'LastName': 'Luco', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Hospital San José, Santiago, Chile.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Pérez', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Kattan', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00777-x']
1663,32325004,Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in  De Novo  Respiratory Failure. A Pilot Study.,"Rationale:  The role of inspiratory effort still has to be determined as a potential predictor of noninvasive mechanical ventilation (NIV) failure in acute hypoxic  de novo  respiratory failure. Objectives:  To explore the hypothesis that inspiratory effort might be a major determinant of NIV failure in these patients. Methods:  Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled. Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate were recorded on admission and 2-4 to 12-24 hours after NIV start and were tested for correlation with outcomes. Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5 [30-36] cm H 2 O;  P  < 0.0001), whereas other variables differed later. ΔPes was not related to other predictors of NIV failure at baseline. NIV-induced reduction in ΔPes of 10 cm H 2 O or more after 2 hours of treatment was strongly associated with avoidance of intubation and represented the most accurate predictor of treatment success (odds ratio, 15; 95% confidence interval, 2.8-110;  P  = 0.001 and area under the curve, 0.97; 95% confidence interval, 0.91-1;  P  < 0.0001). Conclusions:  The magnitude of inspiratory effort relief as assessed by ΔPes variation within the first 2 hours of NIV was an early and accurate predictor of NIV outcome at 24 hours.Clinical trial registered with www.clinicaltrials.gov (NCT03826797).",2020,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5",['Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled'],[],"['Noninvasive Ventilation Outcome', 'ΔPes and ΔPes/ΔPl ratio', 'Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",30.0,0.374853,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tonelli', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fantini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tabbì', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Castaniere', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Pellegrino', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Della Casa', 'Affiliation': 'Radiology Unit and.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Statistics Unit, Department of Diagnostics, Clinical and Public Health Medicine, and.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Girardis', 'Affiliation': 'Intensive Care Unit, Department of Surgical, Medical, Dental and Morphological Sciences related to Transplants Oncology and Regenerative Medicine, University Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy; and.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nava', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Clini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Marchioni', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2512OC']
1664,32796016,Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries.,"BACKGROUND


Lateral ankle sprains are common in indoor sports. High shoe-surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes.
METHODS


In this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or 'do-as-usual'. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented.
RESULTS


480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino.
CONCLUSION


Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
TRIAL REGISTRATION NUMBER


NCT03311490.",2020,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
","['480 participants completed the trial', '510 participants with previous ankle injuries', 'lateral ankle sprains among indoor sport athletes', '510 subelite indoor sport athletes with a previous lateral ankle sprain']","[""Spraino or 'do-as-usual"", 'Spraino']","['incidence rate ratios', 'Time loss per injury', 'risk of lateral ankle sprains and less time loss', 'harms, fear-of-injury and ankle pain', 'Match and training exposure, number of injuries and associated time loss', 'severe lateral ankle sprains']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C2874943', 'cui_str': 'Fear of injury'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",510.0,0.302455,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
","[{'ForeName': 'Filip Gertz', 'Initials': 'FG', 'LastName': 'Lysdal', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark fgly@hst.aau.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel Bek', 'Initials': 'MB', 'LastName': 'Clausen', 'Affiliation': 'Department of Orthopedic Surgery, Sports Orthopedic Research Center-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mann', 'Affiliation': 'Clinical Research Centre, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pelle Baggesgaard', 'Initials': 'PB', 'LastName': 'Petersen', 'Affiliation': 'Section for Surgical Pathophysiology 7621, Rigshospitalet, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thor Buch', 'Initials': 'TB', 'LastName': 'Grønlykke', 'Affiliation': 'Spraino ApS, Copenhagen, Denmark.'}, {'ForeName': 'Uwe G', 'Initials': 'UG', 'LastName': 'Kersting', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Thorborg', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101767']
1665,32803798,Surgical treatment of peri-implantitis defects with two different xenograft granules: A randomized clinical pilot study.,"OBJECTIVES


To investigate whether xenograft EB (EndoBon) is non-inferior to xenograft BO (Bio-Oss) when used in reconstructive surgery of peri-implant osseous defects.
MATERIALS AND METHODS


Dental patients with one implant each demonstrating peri-implantitis were randomized to receive surgical debridement and defect fill with either BO or EB. Changes in bone level (BL) and intrabony defect depth (IDD) evaluated radiographically were the primary outcomes. The secondary outcomes included changes in probing pocket depth (PPD), bleeding on probing (BoP), and suppuration on probing (SoP). All outcomes were recorded before treatment and at 6 and 12 months post-treatment.
RESULTS


Twenty-four patients (n = 11 BO, n = 13 EB) completed the study. Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p ≤ .001). At 12 months, both groups presented with IDD reductions of 2.5-3.0 mm on average. The inter-group differences were not statistically significant at all time points and for all the examined parameters (p > .05). While the radiographic defect fill in both groups exceeded > 1 mm and can be considered treatment success, successful treatment outcomes as defined by Consensus Reporting (no further bone loss, PPD ≤ 5 mm, no BOP, and no SoP) were identified in 2/11 (18%) BO and 0/13 (0%) EB individuals (Fisher's exact test, p = .199).
CONCLUSIONS


Within the limitations of this pilot study, the application of xenograft EB showed to be non-inferior to xenograft BO when used in reconstructive surgery of peri-implant osseous defects.",2020,Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p≤0.001).,"['Dental patients with one implant each, demonstrating peri-implantitis', 'Twenty-four patients (n=11 BO, n=13 EB) completed the study']","['xenograft EB (EndoBon', 'surgical debridement and defect with either BO or EB', 'xenograft EB']","['bone level (BL) and intrabony defect depth (IDD) evaluated radiographically', 'bone loss, PPD ≤5 mm, no BOP, and no SoP', 'changes in probing pocket depth (PPD), bleeding on probing (BoP) and suppuration on probing (SoP', 'clinical and radiographic parameters', 'IDD reductions', 'radiographic defect fill']","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0535594', 'cui_str': 'endobon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",24.0,0.0409807,Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p≤0.001).,"[{'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Polymeri', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Anssari-Moin', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'van der Horst', 'Affiliation': 'Department Oral Implantology and Prosthodontics, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wismeijer', 'Affiliation': 'Department Oral Implantology and Prosthodontics, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marja L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Loos', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, The Netherlands.'}]",Clinical oral implants research,['10.1111/clr.13651']
1666,32798834,The role of parental psychological flexibility in childhood asthma management: An analysis of cross-lagged panel models.,"OBJECTIVE


This is a secondary analysis of a previously reported randomized controlled trial, aimed at examining the mediating role of parental psychological flexibility (PF) in an Acceptance and Commitment Therapy (ACT)-based childhood asthma management program for parents.
METHODS


The participants were 168 parents (mean age (SD) = 38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD) = 6.81 (2.50) years; 62% boys). They were randomly allocated to either the program composed of a four-session, group-based ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group). The parents underwent assessments at baseline, and immediately, 3-months, and 6-months after the intervention for the following outcomes: PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21); and the asthma symptoms and use of inhaled bronchodilators of their children.
RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
CONCLUSION


ACT makes a unique contribution to improving the health outcomes of parents and their children diagnosed with asthma through fostering parental PF.",2020,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","['childhood asthma management', 'participants were 168 parents (mean age (SD)\u202f=\u202f38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD)\u202f=\u202f6.81 (2.50) years; 62% boys', 'parents', 'parents and their children diagnosed with asthma through fostering parental PF']","['ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group', 'ACT', 'parental psychological flexibility (PF', 'inhaled bronchodilators of their children']","['nighttime symptoms', 'childhood asthma symptoms', 'parental psychological distress', 'PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",168.0,0.118973,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","[{'ForeName': 'Yuen Yu', 'Initials': 'YY', 'LastName': 'Chong', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. Electronic address: conniechong@cuhk.edu.hk.'}, {'ForeName': 'Yim Wah', 'Initials': 'YW', 'LastName': 'Mak', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Alice Yuen', 'Initials': 'AY', 'LastName': 'Loke', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110208']
1667,32798835,"Effects of food-related behavioral activation therapy on eating styles, diet quality and body weight change: Results from the MooDFOOD Randomized Clinical Trial.","OBJECTIVE


Depression and obesity are bi-directionally related, eating styles and diet quality are two important factors associated with both. It remains uncertain if and how these two factors can be modified. Therefore the current study aims to investigate whether food-related behavioral activation therapy (F-BA), targeting mood, dietary habits and food related behavior, can improve eating styles, and diet quality and reduce body weight in adults with overweight or obesity and subsyndromal depressive symptoms.
METHODS


Data were derived from the MooDFOOD prevention trial, a 2x2 factorial RCT investigating the effect of nutritional strategies on prevention of depression. Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight were analyzed among 1025 adults who either received F-BA or no intervention for 12 months. Intervention effect was tested by longitudinal analysis of covariance using mixed model analysis.
RESULTS


The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA. The effect of the F-BA therapy on emotional and uncontrolled eating was stronger in those with higher baseline depressive symptoms (IDS-SR). The F-BA did also lead to small improvements in MDS (β=1.95, p<.001), but not to change in body weight.
CONCLUSION


Our trial showed no reduction in bodyweight, but provides support for the possibility to improve both unhealthy eating styles and diet quality using an intervention targeting these specifically, although effects were small [Trial registration: clinicaltrials.gov NCT02529423].",2020,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","['adults with overweight or obesity and subsyndromal depressive symptoms', '1025 adults who either received']","['food-related behavioral activation therapy', 'F-BA therapy', 'F-BA or no intervention', 'food-related behavioral activation therapy (F-BA']","['Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight', 'uncontrolled eating', 'emotional and uncontrolled eating', 'eating styles, and diet quality and reduce body weight', 'cognitive restrained eating', 'emotional', 'eating styles, diet quality and body weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",1025.0,0.112594,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","[{'ForeName': 'Nadine P G', 'Initials': 'NPG', 'LastName': 'Paans', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands. Electronic address: n.paans@ggzingeest.nl.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatic and Psychotherapy, Senckenberg Distinguished Professorship, Goethe-University Frankfurt, Frankfurt A.M., Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110206']
1668,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
1669,32798927,A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder.,"BACKGROUND


Music therapy is based on the use of musical elements by a trained and qualified therapist. Clinical researches have suggested that children with Autism Spectrum Disorders (ASD) may benefit from MT. In this regard, this study examines if MT is more effective than simply listening to music for children with ASD.
METHOD


A 8-month RCT has been carried out comparing music therapy (MT) to music listening (ML) for children with ASD aged from 4 to 7 years old. Thirty-seven participants were randomly assigned to one of the two groups (MT vs. ML). The outcome measures were the Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML).
RESULTS


CGI scores decreased more for participants in the MT than in the ML condition. This clinical improvement was associated with an improvement of autistic symptoms on lethargy and stereotypy ABC subscales.
CONCLUSION


Our findings suggest that music therapy is more efficient than music listening for children with ASD. The present study thus supports the consideration of MT as a rightful add-on to ASD healthcare programs.",2020,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","['children with ASD', 'children with ASD aged from 4 to 7 years old', 'children with autism spectrum disorder', 'Thirty-seven participants', 'children with Autism Spectrum Disorders (ASD']","['MT', 'music therapy', 'music therapy and music listening', 'music therapy (MT) to music listening (ML']","['autistic symptoms on lethargy and stereotypy ABC subscales', 'Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML', 'CGI scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0933362,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rabeyron', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France. Electronic address: thomas.rabeyron@univ-lorraine.fr.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'Robledo Del Canto', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre for Music and Science, University of Cambridge, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Carasco', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bisson', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bodeau', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Vrait', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': 'Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Inserm U1114, France; Collègue Universitaire des Médecines Intégratives et Complémentaires (CUMIC), Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}]",Psychiatry research,['10.1016/j.psychres.2020.113377']
1670,32805594,Behavioral changes in preterm children during nasogastric tube feeding. Comparative study of manual administration by parents versus mechanical administration via electric syringe pump.,"INTRODUCTION


Manual feeding by parents using a syringe, a widespread practice in Sweden since the 1980s, favors parents' involvement in childcare tasks. This approach is used in our neonatal unity since 2007.
OBJECTIVE


To study the behavioral changes of preterm children during nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA) over a 30-minute period.
METHOD


This is a randomized, crossover study conducted in the neonatology unit of Toulouse. Preterm children under 33 weeks of age and over 7 days of life were included. A video recording was performed to assess the children's behavioral response, using the Dsilna score. The reviewer was blinded.
RESULTS


15 preterm children with a median gestational age of 30.1 weeks and a median birth weight of 1.210 g were included from March to October 2012. The facility, environment, and state of alertness of children were similar in both groups. Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"". Although not significant, motor withdrawal signs were more apparent and fluctuating in the ESA group. Qualitative analysis of NIDCAP observations confirms this data.
CONCLUSION


There are behavior changes of preterm children during nasogastric tube feeding. This pilot study showed previously undescribed results: MAP is associated with more common well-being signs and could be more widely used in neonatal units.",2020,"Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"".","['15 preterm children with a median gestational age of 30.1\xa0weeks and a median birth weight of 1.210\xa0g were included from March to October 2012', 'preterm children during nasogastric tube feeding', 'Preterm children under 33\xa0weeks of age and over 7\xa0days of life were included', 'preterm children']","['nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA', 'manual administration by parents versus mechanical administration via electric syringe pump', 'ESA']","['Behavioral changes', 'motor withdrawal signs', 'facility, environment, and state of alertness of children']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric feeding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0192456', 'cui_str': 'Nasogastric feeding'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0181332', 'cui_str': 'Syringe pump'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C4304523', 'cui_str': 'Withdrawal sign'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",15.0,0.0633833,"Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"".","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Angot', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France. Electronic address: angot-florent@laposte.net.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Van Vooren', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Castex', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France; Nursery Hospital, Nîme, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Glorieux', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Casper', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France; Department of Neonatology, University Hospital, Doha, Qatar.'}]",Early human development,['10.1016/j.earlhumdev.2020.105151']
1671,32805700,"The effect of circadian-adjusted LED-based lighting on sleep, daytime sleepiness and biomarkers of inflammation in a randomized controlled cross-over trial by pragmatic design in elderly care home dwellers.","AIM


Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities. The project aimed to study the possible effect of indoor circadian-adjusted LED-lighting (CaLED) in the elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation.
METHODS


A 16-week trial study was performed to follow the intervention and control groups using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation.
RESULTS


There was no significant impact on sleep improvement after the short intervention time when analyzing the PSQI and ESS results. However, we found several challenges using these tools for this specific group of individuals. Thus, important knowledge was gained for future studies in elderly care home dwellers. The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention. This study represents a first-to-date attempt to ameliorate the adverse effects of sleep disturbances that characterize a randomly chosen group of elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment.
CONCLUSION


In this pragmatic randomized study of home dwelling individuals we were not able to demonstrate an improved sleep pattern as judged by PSQI, ESS or a change in inflammatory state.",2020,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"['elderly care home dwellers', ""elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation"", 'elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment', 'Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities', 'home dwelling individuals']","['indoor circadian-adjusted LED-lighting (CaLED', 'circadian-adjusted LED-based lighting']","['sleep improvement', 'inflammation state', 'sleep, daytime sleepiness and biomarkers of inflammation', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0167666,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"[{'ForeName': 'Christine Borgen', 'Initials': 'CB', 'LastName': 'Linander', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: christine.borgen.linander@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: thomas.kallemose@regionh.dk.'}, {'ForeName': 'Lillian Moerch', 'Initials': 'LM', 'LastName': 'Joergensen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: lillian.moerch.joergensen@regionh.dk.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: ove.andersen@regionh.dk.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Nehlin', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: jan.nehlin@regionh.dk.'}, {'ForeName': 'Baker Nawfal', 'Initials': 'BN', 'LastName': 'Jawad', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: baker.jawad@regionh.dk.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104223']
1672,32805748,The Truview PCD™ video laryngoscope for nasotracheal intubation in pediatric patients: A subset analysis from a prospective randomized controlled trial.,,2020,"One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel).",['Pediatric Patients'],"['Video laryngoscopy', 'FDA-approved video laryngoscope', 'Truview PCD™ Video Laryngoscope']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",[],,0.0696842,"One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel).","[{'ForeName': 'Proshad Nemati', 'Initials': 'PN', 'LastName': 'Efune', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Saynhalath', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'James-Michael', 'Initials': 'JM', 'LastName': 'Blackwell', 'Affiliation': 'Department of Population and Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Steiner', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Olomu', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szmuk', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center and Children's Health Medical Center, Dallas, TX, USA.""}]",Paediatric anaesthesia,['10.1111/pan.14005']
1673,32805758,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,,2020,disease.,['low-risk non-muscle-invasive bladder cancer'],"['endovescical mitomycin-C versus surgical management', 'mitomycin-C vs surgical management']",[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.0445187,disease.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Department of Urology, San Raffaele Hospital and Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Department of Urology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",BJU international,['10.1111/bju.15214']
1674,32825977,Persian manual therapy method for chronic low-back pain with lumbar radiculopathy; a randomized controlled trial.,"BACKGROUND


Manual therapy is a non-surgical approach for management of musculoskeletal symptoms. This study investigated safety and efficacy of a Persian manual therapy method (Fateh technique) for management of chronic low-back pain (LBP) and radiculopathy.
METHODS


In this controlled trial, 52 eligible patients with chronic LBP and lumbar radiculopathy were randomly assigned into two intervention groups; one received a 16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises. The other group only did the two daily exercises for four weeks. Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result were assessed at the baseline, and in fourth and eighth weeks of trial.
RESULTS


Data of 48 participants was analyzed. Distributions of age, sex, and duration of symptoms in two groups were the same. Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters. Compared with home exercise, Fateh technique was associated with greater changes in all outcomes. No adverse event has occurred.
CONCLUSIONS


Fateh technique is safe and effective for management of LBP and radiculopathy in patients without severe progressive symptoms.",2020,"Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters.","['52 eligible patients with chronic LBP and lumbar radiculopathy', 'chronic low-back pain with lumbar radiculopathy', '48 participants was analyzed', 'patients without severe progressive symptoms']","['16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises', 'Persian manual therapy method (Fateh technique']","['pain, radiculopathy, paresthesia, and disability', 'Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result', 'safety and efficacy', 'body flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",52.0,0.117942,"Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters.","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Sanei', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Roozafzai', 'Affiliation': 'Digestive Disease Research Institute, Shariati Hopital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shobeir Rostami', 'Initials': 'SR', 'LastName': 'Abousaidi', 'Affiliation': 'Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Hamze', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir-Masoud', 'Initials': 'AM', 'LastName': 'Negarestani', 'Affiliation': 'Department of Radiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mokaberinejad', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: rmokaberi@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.015']
1675,32825981,A randomized clinical trial for the effect of static stretching and strengthening exercise on pelvic tilt angle in LBP patients.,"BACKGROUND


Stretching and strengthening exercises are commonly used to improve muscle shortness of the hamstring as any tension in this muscle can have an effect on the pelvic posture. Thus, the aim of this study was to evaluate the effects of two methods of improving short hamstring on the angle of pelvic tilt in LBP sufferers.
METHODS


Forty-five low back pain patients aged 19-59 years with hamstring tightness participated in this clinical trial. The patients were categorized randomly into three groups: 1- static stretching, 2-strengthening exercise and 3-control group. The two intervention groups received physical therapy and special exercise program thrice a week in a total of 12 sessions, while the control group received only conventional physical therapy. Before and after the treatment implementation, the pelvic tilt and straight leg raising (SLR) degree were assessed for each group.
RESULT


After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups. In addition, no statistically significant correlation was observed between the pelvic tilt and SLR test [except for the strengthening exercise group (Pearson correlation coefficient = -0.54, P < 0.05)].
CONCLUSIONS


In LBP sufferers, both static stretching and strengthening of hamstring muscle in its lengthened position caused elongation and extensibility in the hamstring muscle and increased SLR test score, but did not change pelvic tilt angle.",2020,"After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups.","['LBP patients', 'Forty-five low back pain patients aged 19-59 years with hamstring tightness participated in this clinical trial', 'LBP sufferers']","['strengthening exercise', 'physical therapy and special exercise program', '1- static stretching, 2-strengthening exercise and 3-control group', 'control group received only conventional physical therapy', 'static stretching and strengthening exercise', 'Stretching and strengthening exercises']","['pelvic tilt angle', 'pelvic tilt and straight leg raising (SLR) degree', 'pelvic tilt and SLR test', 'pelvic tilt angle and SLR score changes', 'SLR test score']","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0207692,"After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups.","[{'ForeName': 'MohammadBagher', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': 'Rehabilitation and Sport Medicine Department, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: mbshamsi@yahoo.com.'}, {'ForeName': 'Soodeh', 'Initials': 'S', 'LastName': 'Shahsavari', 'Affiliation': 'Health Information Management Department, Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: soodeh_shahsavari@yahoo.com.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Safari', 'Affiliation': 'Research Management Office, Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: safari.ameneh0@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: maryam.mirzaee@kums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.001']
1676,32825982,Effects of non-linear resistance training and curcumin supplementation on the liver biochemical markers levels and structure in older women with non-alcoholic fatty liver disease.,"BACKGROUND


With increasing age, non-alcoholic fatty liver disease is very common among women with low levels of physical activity. Nonlinear resistance training is one of the new methods to help patients who have low levels of physical activity. Curcumin is an herbal supplement that has anti-inflammatory effects. The present study aimed to examine the effects of nonlinear resistance training and curcumin supplementation on the liver structure and biochemical markers in obese older women with non-alcoholic fatty liver disease.
METHODS


Forty-five obese women with non-alcoholic fatty liver disease were randomly assigned into resistance training (RT), curcumin supplement (C), resistance training with curcumin supplement (RTC), and placebo (P) groups. The RT and RTC groups received 12-weeks of nonlinear resistance training while the C and P groups had a normal sedentary lifestyle. Daily, the C and RTC groups received a curcumin capsule while the P and RT groups were given a placebo capsule. Blood sampling and ultrasonography were taken before and after the protocol.
RESULTS


Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels significantly decreased in the RT and RTC groups (P ≤ 0.05) but not in the C and P groups (P > 0.05). Alkaline phosphatase (ALP), total bilirubin (TB) levels, platelet counts (PLT), and liver structure did not significantly change in all groups (P > 0.05). Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
CONCLUSION


12-week non-linear resistance training has beneficial effects on non-alcoholic fatty liver disease in older obese women.",2020,"Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
","['women with low levels of physical activity', 'Forty-five obese women with non-alcoholic fatty liver disease', 'older women with non-alcoholic fatty liver disease', 'older obese women', 'obese older women with non-alcoholic fatty liver disease']","['non-linear resistance training and curcumin supplementation', 'Resistance training alone and with curcumin supplementation', 'resistance training (RT), curcumin supplement (C), resistance training with curcumin supplement (RTC), and placebo', 'Nonlinear resistance training', 'nonlinear resistance training and curcumin supplementation', 'linear resistance training', 'nonlinear resistance training']","['Alkaline phosphatase (ALP), total bilirubin (TB) levels, platelet counts (PLT), and liver structure', 'liver function', 'Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels', 'liver structure and biochemical markers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}]",45.0,0.113311,"Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
","[{'ForeName': 'Baharak', 'Initials': 'B', 'LastName': 'Moradi Kelardeh', 'Affiliation': 'Phd Exercise Physiology, Sama Technical and Vocational Training College, Islamic Azad University, Esfahan (Khorasgan) Branch, Esfahan, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Rahmati-Ahmadabad', 'Affiliation': 'Department of Physical Education, Pardis Branch, Islamic Azad University, Pardis, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Farzanegi', 'Affiliation': 'Department of Exercise Physiology, Sari Branch, Islamic Azad University, Sari, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Helalizadeh', 'Affiliation': 'Department of Exercise Physiology, Sport Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Mohammad-Ali', 'Initials': 'MA', 'LastName': 'Azarbayjani', 'Affiliation': 'Department of Exercise Physiology, Central Tehran Branch, Islamic Azad University, Tehran, Iran. Electronic address: m_azarbayjani@iauctb.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.021']
1677,32825983,Treatment of panic disorder by trigeminal nerve manipulation: A case series.,"This is a report on two cases of patients with acute severe panic disorder relieved of their symptoms by manual manipulations of the trigeminal nerve's alveolar branches. The manipulations were performed via the oral cavity during one session, or two consecutive sessions less than a week apart. No other effective treatment was administered prior, concurrently or since the time of the treatment. The recovery from panic disorder was immediate and lasted for the entire period of observation of three years. The authors used the same procedure and achieved identical clinical results treating ten other clients over a period of three years. This was not a planned experiment or randomized study. Rather, this report presents clinical evidence and the authors' hypothesis based on clinical data and literature review.",2020,The recovery from panic disorder was immediate and lasted for the entire period of observation of three years.,['patients with acute severe panic disorder'],['trigeminal nerve manipulation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}]","[{'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],10.0,0.0143006,The recovery from panic disorder was immediate and lasted for the entire period of observation of three years.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Birstein', 'Affiliation': 'Pittsburgh Integrative Mental Health, 160 N. Craig St. Suite 212 Pittsburgh, PA, 15213, USA. Electronic address: birstein@gmail.com.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gusky', 'Affiliation': 'Pittsburgh Integrative Mental Health, 160 N. Craig St. Suite 212 Pittsburgh, PA, 15213, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.002']
1678,32825989,Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial.,"BACKGROUND


There are a number of long-term postoperative complications after coronary artery bypass graft (CABG) surgery. Pulmonary function is decreased by 12% and 30%-50% of the patients have chronic thoracic pain.
METHODS


This randomised controlled trial with two parallel groups aimed to explore the effectiveness of osteopathic treatments (OTs) on these conditions. The standard care (SC) group and the and OT group received a 12-week standard cardiac rehabilitation programme, which was supplemented with four OTs for the OT group only. The outcome assessors were blinded to the patients' allocation.
RESULTS


Eighty-two patients with median sternotomy after CABG surgery were randomly allocated in a 1:1 ratio (SC: n = 42, OT: n = 42). Slow vital capacity and pain intensity were measured at baseline and at 12 weeks and 52 weeks after surgery. Pain intensity was significantly lower in the OT group 12 weeks after surgery (3.6-0.80 vs. 2.6 to 1.2, p = 0.030). One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014). No significant changes between groups were found in pulmonary function. There were no adverse events reported.
CONCLUSIONS


From this study, it can be concluded that the addition of OT to exercise-based cardiac rehabilitation may lead to significantly greater reductions in thoracic pain after CABG surgery.
TRIAL REGISTRATION


This study was registered on ClinicalTrials.gov (NCT01714791).",2020,"One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014).",['Eighty-two patients with median sternotomy after CABG surgery'],"['standard cardiac rehabilitation programme', 'OT', 'coronary artery bypass graft (CABG) surgery', 'osteopathic treatments (OTs']","['chronic thoracic pain', 'Pulmonary function', 'pain intensity', 'Slow vital capacity and pain intensity', 'Pain intensity', 'thoracic pain', 'pulmonary function']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}]",82.0,0.255498,"One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014).","[{'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Roncada', 'Affiliation': 'Jessa Hospital, Heart Centre Hasselt, Hasselt, Belgium; Commission for Osteopathic Research, Practice and Promotion, Mechelen, Belgium. Electronic address: gert.roncada@telenet.be.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.03.004']
1679,32827221,Transcranial Magnetic Stimulation Promotes Gait Training in Parkinson Disease.,"OBJECTIVE


To determine whether priming with 1 or 25Hz repetitive transcranial magnetic stimulation (rTMS) will enhance the benefits from treadmill training up to 3 months postintervention in people with Parkinson disease (PD), and to evaluate the underlying changes in cortical excitability.
METHODS


This randomized double-blind, placebo-controlled trial was conducted between October 2016 and December 2018. Fifty-one participants with PD were randomized to receive 12 sessions of rTMS (25Hz, 1Hz, or sham) followed by treadmill training. All participants were assessed at baseline and 1 day, 1 month, and 3 months postintervention. Primary outcome was fastest walking speed, and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS.
RESULTS


The 1 and 25Hz rTMS groups produced a greater improvement in fastest walking speed at 1 day and 3 months postintervention than the sham group. Only the 1 and 25Hz rTMS groups sustained the improvements in TUG, and had a significant improvement in DT-TUG and MDS-UPDRS-III for up to 3 months. Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.
INTERPRETATION


Priming with 1 and 25Hz rTMS can augment the benefits of treadmill training and lead to long-term motor improvement up to 3 months postintervention. The motor improvement at follow-up was associated with a normalization of cortical excitability, which in turn suggests an alteration of the homeostatic plasticity range. Rebalancing cortical excitability by rTMS appears critical for plasticity induction. ANN NEUROL 2020.",2020,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"['Oct 2016 and Dec 2018', ""Parkinson's disease"", 'Fifty-one participants with PD', ""people with Parkinson's disease (PD""]","['Transcranial magnetic stimulation promotes gait training', '1 Hz or 25 Hz repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'rTMS (25 Hz, 1 Hz or sham) followed by treadmill training', 'placebo']","['fastest walking speed', 'cortical silent period and short-interval intracortical inhibition', 'DT-TUG and MDS-UPDRS-III', ""fastest walking speed and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS""]","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",51.0,0.305734,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"[{'ForeName': 'Chloe Lau-Ha', 'Initials': 'CL', 'LastName': 'Chung', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Margaret Kit-Yi', 'Initials': 'MK', 'LastName': 'Mak', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA.'}]",Annals of neurology,['10.1002/ana.25881']
1680,32822218,Promote or inhibit: An inverted U-shaped effect of workload on driver takeover performance.,"OBJECTIVE


In conditional automated driving (SAE Level 3), drivers are required to take over their vehicles when the automated systems fail. Non-driving related tasks (NDRTs) can positively or negatively affect takeover safety, but the underlying reasons for this inconsistency remain unclear. This study aims to investigate how various workload levels generated by NDRTs may influence the takeover performance of drivers and the lead time they require.
METHOD


Fifty drivers were randomly distributed into five groups, which corresponded to five workload levels (1-4 levels generated by Tetris game; control level generated by monitoring). Each driver completed vehicle takeover tasks upon receiving takeover requests with various lead times (3, 5, 7, 9, and 11 s) while engaging in NDRTs. The drivers' takeover performance and subjective opinions were recorded.
RESULTS


Drivers in the moderate workload condition (i.e., level 3) had significantly shorter takeover times and better takeover quality than those in the lower (i.e., level 1 and level 2) or higher (i.e., level 4) workload conditions. They also subjectively required less lead time in the moderate condition. Moreover, the drivers rated 7 s as the most appropriate lead time despite the improvement in their overall takeover performances with increased lead time.
CONCLUSIONS


This study found an inverted U-shaped relationship between the drivers' workload generated by NDRTs and takeover performance. The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers. These findings help understand the relationship of drivers' workload during the automation and takeover performance in conditional automated driving. An important recommendation emerging from this work is to investigate what should be the most efficient method to detect the drivers' workload state real-time and give feedback to them when it comes to overload or underload during the automated driving.",2020,"The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers.",['Fifty drivers'],[],"['shorter takeover times and better takeover quality', 'moderate workload level']","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.0299729,"The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Changxu', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'State Key Lab of CAD&CG, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}]",Traffic injury prevention,['10.1080/15389588.2020.1804060']
1681,32822656,Physiology-guided revascularization versus optimal medical therapy of non-culprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial.,"BACKGROUND


Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap.
METHODS AND DESIGN


The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary endpoint will be the patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year. The key secondary endpoint will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5years. The sample size for the study is 1400 patients.
IMPLICATIONS


The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD in order to improve their clinical outcomes.",2020,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","['1400 patients', 'elderly patients with myocardial infarction', 'Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion', 'elderly patients']",['Physiology-guided revascularization versus optimal medical therapy'],"['patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year', 'composite of cardiovascular death and MI', 'Quality of life and physical performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0629355,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Biscaglia', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy. Electronic address: bscsmn@unife.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Ignacio Amat', 'Initials': 'IA', 'LastName': 'Santos', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernandez-Aviles', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Lanzilotti', 'Affiliation': 'U.O.C. Cardiologia, Ospedale Maggiore, Largo Nigrisoli 2, Bologna, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Department of Cardiology, Infermi Hospital, Rivoli, Italy; Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Fileti', 'Affiliation': 'Cardiology Department, S. Maria delle Croci Hospital, Viale Randi 5, Ravenna, Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Instituto de Investigación Hospital La Paz (IDIPAZ), University Hospital La Paz, Madrid, Spain, Madrid; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giannini', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Iginio', 'Initials': 'I', 'LastName': 'Colaiori', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Menozzi', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ruozzi', 'Affiliation': 'Cardiology Unit, Ospedale Civile di Baggiovara, Modena, Italy.'}, {'ForeName': 'Enrique Gutiérrez', 'Initials': 'EG', 'LastName': 'Ibañes', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'José Luis Díez', 'Initials': 'JLD', 'LastName': 'Gil', 'Affiliation': 'Servicio de Cardiología, H. Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giuseppe Biondi', 'Initials': 'GB', 'LastName': 'Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Calle del Prof Martin Lagos s/n, Madrid, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Via Pansini, Naples, Italy.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy; Institute of Cardiology, Jagiellonian University Medical College, ul. Sw Anny 12, Krakow, Poland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy; Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}]",American heart journal,['10.1016/j.ahj.2020.08.007']
1682,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped effect. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the cognitive tasks. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
1683,32823218,Effect of adjunctive single dose parenteral Vitamin D supplementation in major depressive disorder with concurrent vitamin D deficiency: A double-blind randomized placebo-controlled trial.,"Adjunctive vitamin D replacement is a theoretically promising strategy to improve outcomes in major depression. Our objective was to assess the efficacy of a single parenteral dose of vitamin D supplementation at baseline as an adjunct to treatment as usual on change in depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes) at the end of 12 weeks when compared to treatment as usual in patients with major depression and concurrent Vitamin D deficiency. Eligible participants were randomized to receive either treatment as usual (TAU; n = 23) or TAU plus single parenteral dose of 3,00,000 IU of vitamin D (n = 23) at baseline. Rater-blinded assessments of depression (primary outcome), quality of life (QoL) and clinical severity of illness were obtained at baseline, and end of follow-up (12 weeks). Intent-to-treat analyses were performed on the entire randomized sample. The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase. These findings indicate that a single parenteral dose (3,00,000 IU) of adjunctive vitamin D replacement at baseline is an effective and well tolerated intervention in major depressive disorder with concurrent Vitamin D deficiency. Additionally, it points to a possible role for vitamin D in the pathophysiology of depression and supports personalized approaches for treatment of major depressive disorder.",2020,"The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase.","['major depression with concurrent vitamin D deficiency', 'Eligible participants', 'major depressive disorder with concurrent Vitamin D deficiency', 'patients with major depression and concurrent Vitamin D deficiency']","['adjunctive single dose parental vitamin D replacement', 'vitamin D', 'adjunctive vitamin D replacement', 'TAU plus single parenteral dose of 3,00,000 IU of vitamin D', 'Adjunctive vitamin D replacement', 'vitamin D supplementation', 'placebo']","['depression symptom ratings, quality of life and clinical severity of illness', 'quality of life (QoL) and clinical severity of illness', 'depression ratings', 'depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.409899,"The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase.","[{'ForeName': 'Favaz', 'Initials': 'F', 'LastName': 'Vellekkatt', 'Affiliation': 'Department of Psychiatry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: favazvkptaj@gmail.com.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Psychiatry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: drvmenon@gmail.com.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Rajappa', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: linkmedha@gmail.com.'}, {'ForeName': 'Jayaprakash', 'Initials': 'J', 'LastName': 'Sahoo', 'Affiliation': 'Department of Endocrinology, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: jppgi@yahoo.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.037']
1684,32668114,Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.,"BACKGROUND


Acute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.
METHODS


We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.
RESULTS


Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).
CONCLUSIONS


Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).",2020,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","['critically ill patients with severe acute kidney injury', 'critically ill patients with acute kidney injury', 'Acute Kidney Injury', 'critically ill patients, many of whom receive renal-replacement therapy', '3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group']","['standard strategy (in which renal-replacement therapy', 'Renal-Replacement Therapy', 'accelerated strategy of renal-replacement therapy']","['Adverse events', 'death', 'death from any cause at 90 days', 'lower risk of death', 'renal-replacement therapy']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",3019.0,0.2899,"At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Neill K J', 'Initials': 'NKJ', 'LastName': 'Adhikari', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Dreyfuss', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Gallagher', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Gaudry', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoste', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joannidis', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Liu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Neyra', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alistair D', 'Initials': 'AD', 'LastName': 'Nichol', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Pettilä', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Schneider', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Orla M', 'Initials': 'OM', 'LastName': 'Smith', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Thomé', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Suvi', 'Initials': 'S', 'LastName': 'Vaara', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Weir', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Amanda Y', 'Initials': 'AY', 'LastName': 'Wang', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': ""From the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services, Edmonton (S.M.B.), the Division of Nephrology (R.W.), St. Michael's Hospital and the University of Toronto, Li Ka Shing Knowledge Institute (R.W., B.R.C., O.M.S., K.E.T.), Department of Medicine (R.W., O.M.S.), and Applied Health Research Centre (B.R.C., K.E.T.), St. Michael's Hospital, the Dalla Lana School of Public Health (K.E.T.), the Institute of Health Policy, Management, and Evaluation (R.W., B.R.C.), University of Toronto, and the Department of Critical Care Medicine, Sunnybrook Health Sciences Centre and the University of Toronto (N.K.J.A.), Toronto, the Department of Medicine, Université de Sherbrooke and Centre de Recherche du Centre Hospitalier Universitaire (CHU) de Sherbrooke, Sherbrooke, QC (F.L.), the Division of Critical Care, Juravinski Hospital, McMaster University, Hamilton, ON (B.R.), and the Division of Nephrology, London Health Sciences Centre, London, ON (M.W.) - all in Canada; the Department of Intensive Care, Austin Hospital and Royal Melbourne Hospital, School of Medicine, University of Melbourne, Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University (R.B., A.D.N.), Melbourne, VIC, and the George Institute for Global Health, Concord Clinical School, Faculty of Medicine, University of Sydney, Sydney (M.P.G., A.Y.W.) - both in Australia; the Institute of Primary Health Care, University of Bern, Bern (B.R.C.), and the Department of Critical Care Medicine, CHU Vaudois, Lausanne (A.G.S.) - both in Switzerland; Hôpital Louis Mourier (D.D.) and Université Léonard de Vinci (S.G.), INSERM Unité UMR S1155, Sorbonne Université and Université de Paris, Paris, Hôpital Avicenne, Bobigny (S.G.), and Hôpital Universitaire François Mitterrand, Lipness Team, INSERM Research Center Lipids, Nutrition, Cancer-Unité Mixte de Recherche 1231 and Laboratoire d'Excellence LipSTIC, Centre d'Investigation Clinique-Epidemiologie Clinique, CHU Dijon-Bourgogne, and INSERM Centre d'Investigation Clinique 1432, Université de Bourgogne, Dijon (J.-P.Q.) - all in France; the Department of Critical Care Medicine, Peking Union Medical College Hospital, Beijing (B.D.), and the Department of Critical Care Medicine, Zhongda Hospital Southeast University, Nanjing (H.Q.) - both in China; the Department of Intensive Care, University of Ghent, Ghent, Belgium (E.A.H.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); Vita Salute San Raffaele University and IRCCS San Raffaele Scientific Institute, Milan (G.L.); the Divisions of Nephrology and Critical Care Medicine, University of California, San Francisco, San Francisco (K.D.L.); the Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, and the Regional Intensive Care Unit, Royal Victoria Hospital, Belfast (D.F.M.), and King's College London, Guy's and St. Thomas' Hospital, London (M.O.) - both in the United Kingdom; the Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Auckland (S.P.M.), and the Medical Research Institute of New Zealand (S.P.M.) and the Intensive Care Unit, Wellington Regional Hospital and Medical Research Institute of New Zealand (P.Y.), Wellington - both in New Zealand; the Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky, Lexington (J.A.N.); University College Dublin Clinical Research Centre at St. Vincent's University Hospital, Dublin (A.D.N.); the Division of Nephrology, University of Pittsburgh, and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh (P.M.P.); the Department of Intensive Care, University of Helsinki, and Helsinki University Hospital, Helsinki (V.P., S.V.); Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil (F.T.); and the Department of Anesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Münster, Germany (A.Z.).""}]",The New England journal of medicine,['10.1056/NEJMoa2000741']
1685,32790539,Food and Drug Administration and Institutional Review Board Approval of a Novel Prehospital Informed Consent Process for Emergency Research.,"Research on the management of acute pain in the prehospital setting is fraught with challenges. The prehospital setting is complex due to constrained time, resources, and training. Research activities must not interfere with the underlying clinical priorities of immediate patient stabilization and rapid transport to an appropriate hospital. The patient's pain, fear, and anxiety immediately after a traumatic event may interfere with undertaking an adequate informed consent process. Pain management trials do not satisfy the criteria for application of the U.S. Food and Drug Administration (FDA) 21 CFR 50.24 exception from informed consent. While nonstandard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings. In addition, any study requiring an Investigational New Drug application requires fully documented standard informed consent. Emergency Medical Services agencies and fire departments become research institutions, and paramedics become study staff, but both the institutions and the staff often lack experience conducting human subjects research and are rarely formally affiliated with the academic institution overseeing the research. As such, additional administrative burdens must be overcome in interventional prehospital studies, including additional training in the study protocol, research operations, and human subjects protections. Institutions conducting federally funded studies commit to regulations covering human subjects protections in the form of a Federalwide Assurance (FWA); prehospital organizations participating in research must either obtain an FWA or have coverage extended to them from an academic partner. We describe how these challenges were addressed during Institutional Review Board review and approval of an FDA-regulated randomized placebo-controlled trial of intranasal ketamine (vs. placebo) in acutely injured patients receiving standard of care fentanyl for prehospital pain management (NCT02866071). To our knowledge, this trial is the first instance in the United States of paramedics screening, consenting, enrolling, and administering study medications to patients without direct, real-time support from a dedicated clinical research team.",2020,"While non-standard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings.",['acutely injured patients receiving standard of care fentanyl for prehospital pain management (NCT02866071'],"['intranasal ketamine', 'placebo']","[""patient's pain, fear, and anxiety""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0310375,"While non-standard informed consent processes exist, waiver or alteration of informed consent may be limited if Institutional Review Boards or the FDA consider these studies to involve more than minimal risk related to the setting of the study, even if the interventions themselves might involve no more than minimal risk in other settings.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Droege', 'Affiliation': ''}, {'ForeName': 'Col Richard', 'Initials': 'CR', 'LastName': 'Strilka', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lindsell', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Linke', 'Affiliation': ''}]",Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors,['10.1080/10903127.2020.1806969']
1686,32792250,"Acceptability of an inactivated influenza vaccine delivered by microneedle patch: Results from a phase I clinical trial of safety, reactogenicity, and immunogenicity.","OBJECTIVE


This study sought to evaluate the acceptability of inactivated influenza vaccine delivered by microneedle patch (MNP) in comparison to inactivated influenza vaccine (IIV) delivered by hypodermic needle.
DESIGN, SETTING, AND PARTICIPANTS


From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49 years. Main Outcome(s) and Measure(s). Our participants were randomized to 4 groups of 25 per arm: (1) IIV by MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW. We administered four questionnaires: at Day 0 before and after study product delivery, and at Days 8 and 28.
RESULTS


At baseline, 98.6% of participants receiving MNP vaccination reported an overall positive experience with MNPs, compared to 86.4% for participants receiving IM vaccination. For future influenza vaccination, study participants (N = 99) preferred MNP (n = 65, 69.9%) to injections or nasal spray (n = 20, 21.5%), and the preference for MNP increased from Day 0 to Day 28. Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
CONCLUSIONS AND RELEVANCE


Most participants were accepting of IIV vaccination by MNP and preferred it to injection. Delivery of IIV by MNP may help increase vaccination coverage.",2020,"Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
","['From the general population of Atlanta, Georgia, we screened 112 and enrolled 100 healthy adult subjects ages 18 to 49\xa0years']","['inactivated influenza vaccine delivered by microneedle patch', 'influenza vaccine (IIV) delivered by hypodermic needle', 'injections or nasal spray', 'MNP administered by healthcare worker (HCW), (2) IIV by MNP self-administered by study participants, (3) IIV by intramuscular (IM) injection administered by HCW or (4) placebo by MNP administered by HCW', 'MNP', 'inactivated influenza vaccine delivered by microneedle patch (MNP']","['mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge', 'overall positive experience with MNPs', 'MNP Use Perceptions', 'safety, reactogenicity, and immunogenicity']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0221093', 'cui_str': 'Hypodermic needle'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0282245', 'cui_str': 'Northern Mariana Islands'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.034005,"Factor analyses resulted in two scaled measures including MNP Use Perceptions (a = 0.799, n = 5 items) and MNP Perceived Convenience (a = 0.844, n = 4 items) that were included in longitudinal assessments; while findings reflect significant differences across treatment groups on mean scores for ease of use, MNP perceived protection, MNP reliability, and MNP selection knowledge, all groups reported their belief that influenza vaccination by MNP would be reliable and protective, as well as easy-to-use and convenient.
","[{'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Frew', 'Affiliation': 'The University of Nevada, Las Vegas, School of Public Health, United States; UNLV Population Health & Health Equity Initiative, United States. Electronic address: paula.frew@unlv.edu.'}, {'ForeName': 'Michele Bennett', 'Initials': 'MB', 'LastName': 'Paine', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States; The Hope Clinic of the Emory Vaccine Center, United States.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Schamel', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States.'}, {'ForeName': 'Yunmi', 'Initials': 'Y', 'LastName': 'Chung', 'Affiliation': 'Emory University School of Medicine, Department of Medicine, Division of Infectious Diseases, United States.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Mulligan', 'Affiliation': 'NYU Langone Health, Division of Infectious Diseases and Immunology, United States.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Prausnitz', 'Affiliation': 'Georgia Institute of Technology, School of Chemical and Biomolecular Engineering, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.07.064']
1687,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
1688,32795619,Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins.,"OBJECTIVE


Mechanochemical ablation (MOCA) is a nonthermal nontumescent method of treating saphenous vein insufficiency. The feasibility and short-term results of MOCA are good, but its long-term results are unknown. A randomized study was performed to compare MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in the setting of unilateral great saphenous vein (GSV) insufficiency.
METHODS


Venous outpatient clinic patients with varicose veins (CEAP class C2-C4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients met the inclusion criteria and were willing to participate. Patients were randomized to treatment (2:1:1 for MOCA, EVLA, and RFA, respectively). The state of the GSV with duplex Doppler ultrasound examination and the disease-specific quality of life were assessed at 1 month, 1 year, and 3 years after the treatment.
RESULTS


Some patients declined to continue in the study after randomization; in total, 117 patients underwent treatment. At 3 years, the occlusion rate was significantly lower with MOCA than with either EVLA or RFA (82% vs 100%; P = .005). Quality of life was similar between the groups. In the MOCA group, GSVs that were larger than 7 mm in diameter preoperatively were more likely to recanalize during the follow-up period. The partial recanalizations of proximal GSV observed at 1 year progressed during the follow-up.
CONCLUSIONS


MOCA is a feasible treatment option in an outpatient setting, but its technical success rates are inferior compared with endovenous thermal ablation. Its use in large-caliber veins should be considered carefully.",2020,Quality of life was similar between the groups.,"['117 patients underwent treatment', 'Venous outpatient clinic patients with varicose veins (CEAP class C2-4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients filled the inclusion criteria and were willing to participate', 'insufficient great saphenous veins']","['MOCA', 'Mechanochemical ablation (MOCA', 'EVLA', 'MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA', 'mechanochemical and thermal ablation']","['disease-specific quality of life', 'Quality of life', 'partial recanalizations of proximal GSV', 'occlusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",132.0,0.0265649,Quality of life was similar between the groups.,"[{'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Vähäaho', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland. Electronic address: sari.vahaaho@fimnet.fi.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Halmesmäki', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Albäck', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Noronen', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Venermo', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.08.007']
1689,32795623,Effects of flexibility and strength training on peak hamstring musculotendinous strains during sprinting.,"BACKGROUND


Hamstring injury is 1 of the most common injuries in sports involving sprinting. Hamstring flexibility and strength are often considered to be modifiable risk factors in hamstring injury. Understanding the effects of hamstring flexibility or strength training on the biomechanics of the hamstring muscles during sprinting could assist in improving prevention strategies and rehabilitation related to these injuries. The purpose of this study was to determine the effects of altering hamstring flexibility or strength on peak hamstring musculotendinous strain during sprinting.
METHODS


A total of 20 male college students (aged 18-24 years) participated and were randomly assigned to either a flexibility-intervention group or a strength-intervention group. Each participant executed exercise training 3 times a week for 8 weeks. Flexibility, sprinting, and isokinetic strength testing were performed before and after the 2 interventions. Paired t tests were performed to determine hamstring flexibility or strength intervention effects on optimal hamstring musculotendinous lengths and peak hamstring musculotendinous strains during sprinting.
RESULTS


Participants in the flexibility intervention group significantly increased the optimal musculotendinous lengths of the semimembranosus and biceps long head (p ≤ 0.026) and decreased peak musculotendinous strains in all 3 bi-articulate hamstring muscles (p ≤ 0.004). Participants in the strength-intervention group significantly increased the optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
CONCLUSION


Increasing hamstring flexibility or strength through exercise training may assist in reducing the risk of hamstring injury during sprinting for recreational male athletes.",2020,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","['peak hamstring musculotendinous strains during sprinting', '20 male college students (aged 18-24 years', 'recreational male athletes']","['exercise training', 'flexibility intervention group or a strength intervention group', 'flexibility and strength training', 'hamstring flexibility or strength', 'hamstring flexibility or strength training']","['peak musculotendinous strains', 'peak musculotendinous strain', 'Hamstring flexibility and strength', 'optimal musculotendinous lengths of the semimembranosus and biceps long head', 'optimal musculotendinous lengths of all 3 hamstring muscles', 'Flexibility, sprinting and isokinetic strength testing']","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",20.0,0.0138512,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","[{'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Shangxiao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Best', 'Affiliation': 'UHealth Sports Medicine Institute, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China. Electronic address: lihanjun@bsu.edu.cn.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Center for Human Movement Science, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7135, USA. Electronic address: byu@med.unc.edu.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.08.001']
1690,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
1691,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS


We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS


Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS


Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE


This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
1692,32801102,"Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results.","The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepine acetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured by the Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS). The analyses were conducted on the per-protocol population (PPP) of patients who were randomized to a placebo arm (n = 188) or an ESL-active group that included treatment with adjunctive ESL 800 mg once daily (QD; n = 184) or adjunctive ESL 1200 mg QD (n = 175). General linear models (GLM) were used to measure the association between SSQ change and patient baseline characteristics or percentage change in the SSF from baseline. Associations between changes in the SSQ and changes in the QOLIE-31 and MADRS were examined using GLM with patient baseline characteristics as covariates. Subgroup analyses were performed for patients in the ESL-active group and those treated with ESL 800 mg or ESL 1200 mg. Minimal clinically important difference (MCIDs) thresholds were used to assess improvements in SSQ scores. The analyses included 547 per-protocol patients. Patients using 1 antiepileptic drug (AED) at baseline had greater improvements in the SSQ compared with those receiving 2 AEDs (P = 0.0606). Treatment with ESL 1200 mg was significantly associated with clinically meaningful improvements in the SSQ (P = 0.0005). The SSQ improvements were significantly associated with an SSF reduction of ≥75%, compared with no reduction (P < 0.0001). In the PPP and the ESL-active group, SSQ improvements were significantly associated with improvements in QOLIE-31 Total Score (TS; P < 0.0001) and the Seizure Worry (SW; P < 0.0001) and Social Functioning (SF; P = 0.0030) subscales. In the ESL 1200 mg subgroup, SSQ improvements were significantly associated with improvements in QOLIE-31 TS (P < 0.0001) and the SW (P < 0.0001) and Energy/Fatigue (EF; P = 0.0007) subscales. In the ESL 800 mg subgroup, improvements in the SSQ were significantly associated with improvements in QOLIE-31 TS (P = 0.0362) and the SW (P = 0.0241) subscale. There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL. These findings demonstrated that in this clinical trial population, adding ESL to baseline AED therapy had utility for decreasing seizure severity and improving HRQoL. There were no significant associations between changes in seizure severity and changes in depressive symptoms in patients with FS.",2020,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"['patients with refractory focal (partial-onset) seizures (FS', 'patients with epilepsy', 'patients with focal seizures treated with']","['adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL', 'adjunctive ESL 1200\u202fmg QD', 'ESL-active group that included treatment with adjunctive ESL 800', 'ESL 800\u202fmg or ESL', 'ESL', 'placebo']","['SSF reduction', 'SSQ scores', 'seizure frequency, and health-related quality of life (HRQoL', 'seizure frequency, and health-related quality of life', 'SSQ', 'QOLIE-31 Total Score', 'Seizure Worry', 'QOLIE-31 and MADRS', 'QOLIE-31 TS', 'seizure severity and improving HRQoL', 'Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social Functioning', 'seizure severity and changes in depressive symptoms', 'Energy/Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.147528,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Yale University School of Medicine and Consultant, Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Inc., Suite 3.02, Level 3, Building A, 97 Waterloo Road, Macquarie Corporate Centre, Macquarie Park, New South Wales 2113, Australia. Electronic address: Sam.Colman@covance.com.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Inc., 9801 Washingtonian Blvd., 9th. Floor, Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'G Rhys', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Gwilym.Williams@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107312']
1693,32806754,"Implementation of the WHO Approved ""Tailoring Antimicrobial Resistance Programs (TAP)"" Reduces Patients' Request for Antibiotics.","The misuse of antibiotics is a worldwide public health concern. Behavioral Intervention programs that aim to reduce patients' own request for antibiotics during their visit to primary care clinics is an attractive strategy to combat this problem. We tested the effectiveness of a behavioral modification method known as the Tailoring Antimicrobial resistance Programs (TAP) in reducing the request for antibiotics by patients visiting primary care clinics for mild upper respiratory tract infections (URTIs). A stratified cluster randomized design with two groups pre-post, comparing intervention with the control, was conducted in six health centers. TAP was implemented for eight weeks. Request for antibiotics was assessed before (period 1) and after introducing TAP (period 2). The percentage of patients or their escorts who requested antibiotics in period 1 was 59.7% in the control group and 60.2% in the intervention group. The percentage of patients who requested antibiotics did not significantly change between period 1 and 2 in the control group, who continued to receive the standard of care. The above percentage significantly decreased in the intervention group from 60.2% to 38.5% ( p  < 0.05). We conclude that behavioral change programs including TAP are a viable alternative strategy to address antibiotic misuse in Jordan.",2020,"The percentage of patients who requested antibiotics did not significantly change between period 1 and 2 in the control group, who continued to receive the standard of care.",['patients visiting primary care clinics for mild upper respiratory tract infections (URTIs'],"['Behavioral Intervention programs', 'TAP', 'Antimicrobial resistance Programs (TAP']",['percentage of patients or their escorts who requested antibiotics'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",,0.0222812,"The percentage of patients who requested antibiotics did not significantly change between period 1 and 2 in the control group, who continued to receive the standard of care.","[{'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Kaplan', 'Affiliation': 'Department of Pathology and Microbiology, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Yousef S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Department of Community Medicine and Public Health, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Alfaqih', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Saadeh', 'Affiliation': 'Department of Community Medicine and Public Health, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Al Sawalha', 'Affiliation': 'Anti-Microbial-Resistance Officer, World Health Organization, Jordan Country Office, 11181 Amman, Jordan.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9080507']
1694,32810504,Acute exposure to traffic-related air pollution alters antioxidant status in healthy adults.,"BACKGROUND


Exposure to traffic-related air pollution is associated with an increased risk of cardiovascular and respiratory disease. Evidence suggests that inhaled pollutants precipitate these effects via multiple pathways involving oxidative stress.
OBJECTIVE


Postulating that a decrease in circulating antioxidant levels reflect an oxidative response, we investigated the effect of inhaled diesel exhaust (DE) on the ratio of reduced to oxidized glutathione (GSH/GSSG) in healthy adults, and whether pre-exposure antioxidant supplementation blunted this response. We also examined exposure-related changes in antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels.
METHODS


Nineteen nonsmoking adults participated in a double-blind, randomized, four-way crossover study. Each subject completed 120-min exposures to filtered air and DE (200 μg/m 3 ), with and without antioxidant pretreatment. Antioxidant comprised 1000 mg ascorbate for 7 days and 1200 mg N-acetylcysteine 1 day prior to exposure, with 1000 mg and 600 mg, respectively, administered 2 h prior to exposure. Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression were quantified pre, during and post exposure.
RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p = 0.001) and a 4-fold increase in IL-6 mRNA (p = 0.01) post exposure. Antioxidant pretreatment did not significantly mediate the effect of DE exposure on GSH/GSSG, though appeared to decrease the effect of exposure on IL-6 mRNA expression.
CONCLUSIONS


Acute DE inhalation induced detectable oxidative effects in healthy adults, which were not significantly attenuated by the selected antioxidant pre-treatment. This finding supports the premise that oxidative stress is one mechanism underlying the adverse effects of traffic-related air pollution.",2020,"RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure.","['Nineteen nonsmoking adults', 'healthy adults']","['traffic-related air pollution', 'Antioxidant', 'oxidized glutathione (GSH/GSSG', 'inhaled diesel exhaust (DE']","['GSH/GSSG', 'Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression', 'oxidative effects', 'antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels', 'IL-6 mRNA']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",19.0,0.25279,"RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure.","[{'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Cosselman', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA. Electronic address: kecs@uw.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Stapleton', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Trenga', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA.'}, {'ForeName': 'Timothy V', 'Initials': 'TV', 'LastName': 'Larson', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA; Department of Civil and Environmental Engineering, USA.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Kaufman', 'Affiliation': 'Department of Environmental and Occupational Health Sciences, USA; Department of Medicine, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}]",Environmental research,['10.1016/j.envres.2020.110027']
1695,32811575,Psychedelic science in post-COVID-19 psychiatry.,"The medium- to long-term consequences of COVID-19 are not yet known, though an increase in mental health problems are predicted. Multidisciplinary strategies across socio-economic and psychological levels may be needed to mitigate the mental health burden of COVID-19. Preliminary evidence from the rapidly progressing field of psychedelic science shows that psilocybin therapy offers a promising transdiagnostic treatment strategy for a range of disorders with restricted and maladaptive habitual patterns of cognition and behaviour, notably depression, addiction and obsessive compulsive disorder. The COMPASS Pathways (COMPASS) phase 2b double-blind trial of psilocybin therapy in antidepressant-free, treatment-resistant depression (TRD) is underway to determine the safety, efficacy and optimal dose of psilocybin. Results from the Imperial College London Psilodep-RCT comparing the efficacy and mechanisms of action of psilocybin therapy to the selective serotonin reuptake inhibitor (SSRI) escitalopram will soon be published. However, the efficacy and safety of psilocybin therapy in conjunction with SSRIs in TRD is not yet known. An additional COMPASS study, with a centre in Dublin, will begin to address this question, with potential implications for the future delivery of psilocybin therapy. While at a relatively early stage of clinical development, and notwithstanding the immense challenges of COVID-19, psilocybin therapy has the potential to play an important therapeutic role for various psychiatric disorders in post-COVID-19 clinical psychiatry.",2020,"The COMPASS pathways, phase 2b double blind trial of PAP in antidepressant-free, treatment resistant depression (TRD) is underway across 19 research sites, to determine the safety, efficacy and optimal dose of psilocybin.",[],['psilocybin assisted psychotherapy (PAP'],['efficacy and safety of PAP'],[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",,0.129042,"The COMPASS pathways, phase 2b double blind trial of PAP in antidepressant-free, treatment resistant depression (TRD) is underway across 19 research sites, to determine the safety, efficacy and optimal dose of psilocybin.","[{'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Crockett', 'Affiliation': 'Department of Neurological Intervention and Imaging, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Alexander', 'Affiliation': 'Health Service Executive, Dublin, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Haran', 'Affiliation': 'Daughters of Charity Disability Services, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Sheaf House, Exchange Hall, Tallaght, Dublin, Ireland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Burke', 'Affiliation': 'Sheaf House, Exchange Hall, Tallaght, Dublin, Ireland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brennan', 'Affiliation': 'Sheaf House, Exchange Hall, Tallaght, Dublin, Ireland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': ""O'Keane"", 'Affiliation': 'Department of Psychiatry, Trinity College Dublin, Dublin, Ireland.'}]",Irish journal of psychological medicine,['10.1017/ipm.2020.94']
1696,32814489,Visibility and image quality of peripheral pulmonary arteries in pulmonary embolism patients using free-breathing combined with a high-threshold bolus-triggering technique in CT pulmonary angiography.,"OBJECTIVE


To investigate the visibility of peripheral pulmonary arteries by computed tomography pulmonary angiography (CTPA) and image quality using a free-breathing combined with a high-threshold bolus triggering technique and to explore the feasibility of this technique in pulmonary embolism (PE) patients who cannot hold their breath.
METHODS


Patients with suspected PE who underwent CTPA (n=240) were randomly assigned to two groups: free-breathing (n=120) or breath-holding (n=120).
RESULTS


The mean scanning time or visible pulmonary artery distal branches were not different between the groups. Mean CT main pulmonary artery (MPA) values, apical segment (S1), and posterior basal segment (S10) in the free-breathing group were higher compared with the breath-holding group. The subjective image quality score in the free-breathing group was higher compared with the breath-holding group. In the free-breathing group, no respiratory artifact was observed. In the breath-holding group, obvious respiratory artifacts were caused by severe chronic obstructive pulmonary disease (COPD), dyspnea, or other diseases that preclude patients from holding their breath.
CONCLUSION


The free-breathing mode CTPA combined with a high-threshold bolus triggering technique can provide high quality images with a lower incidence of respiratory and cardiac motion artifacts, which is especially valuable for patients who cannot hold their breath.",2020,The subjective image quality score in the free-breathing group was higher compared with the breath-holding group.,"['Patients with suspected PE who underwent CTPA (n=240', 'pulmonary embolism patients', 'patients who cannot hold their breath', 'pulmonary embolism (PE) patients who cannot hold their breath']","['computed tomography pulmonary angiography (CTPA', 'free-breathing (n=120) or breath-holding', 'free-breathing combined with a high-threshold bolus-triggering technique in CT pulmonary angiography']","['severe chronic obstructive pulmonary disease (COPD), dyspnea', 'mean scanning time or visible pulmonary artery distal branches', 'Visibility and image quality of peripheral pulmonary arteries', 'Mean CT main pulmonary artery (MPA) values, apical segment (S1), and posterior basal segment (S10', 'subjective image quality score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1563135', 'cui_str': 'Suspected pulmonary embolism'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",240.0,0.0266987,The subjective image quality score in the free-breathing group was higher compared with the breath-holding group.,"[{'ForeName': 'Daliang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Xiansheng', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Che', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Yucun', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}]",The Journal of international medical research,['10.1177/0300060520939326']
1697,32815892,Turning Toward Monitoring of Gaze Stability Exercises: The Utility of Wearable Sensors.,"BACKGROUND AND PURPOSE


Few tools are currently available to quantify gaze stability retraining exercises. This project examined the utility of a head-worn inertial measurement unit (IMU) to quantify head movement frequency, velocity, and amplitude during gaze stability exercises.
METHODS


Twenty-eight individuals with multiple sclerosis and complaints of dizziness or a history of falls were randomly assigned to either a strength and aerobic exercise (SAE) or gaze and postural stability (GPS) group. During a 6-week intervention, participants wore a head-mounted IMU 3 times (early, middle, and late). For aim 1, the frequency, mean peak velocity, and mean peak amplitude of head turns during equivalent duration components of group-specific exercises were compared using general linear models. For aim 2, the progression of treatment in the GPS group was examined using general linear regression models for each outcome.
RESULTS


Aim 1 revealed the GPS group demonstrated significantly greater velocity and amplitude head turns during treatment than the SAE group. The frequency of head turns did not significantly differ between the 2 groups. The aim 2 analyses demonstrated that the yaw and pitch frequency of head turns significantly increased during gaze stability exercises over the 6-week intervention. Velocity and amplitude of head turns during yaw and pitch gaze stability exercises did not significantly change.
DISCUSSION AND CONCLUSIONS


A head-worn IMU during rehabilitation distinguished between groups. Furthermore, within the GPS group, the IMU quantified the progression of the frequency of head movements during gaze stability exercises over time.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A320).",2020,"Velocity and amplitude of head turns during yaw and pitch gaze stability exercises did not significantly change.
",['Twenty-eight individuals with multiple sclerosis and complaints of dizziness or a history of falls'],"['SAE', 'strength and aerobic exercise (SAE) or gaze and postural stability (GPS) group', 'head-worn inertial measurement unit (IMU', 'Gaze Stability Exercises', 'GPS']","['velocity and amplitude head turns', 'gaze stability exercises', 'Velocity and amplitude of head turns during yaw and pitch gaze stability exercises', 'frequency, mean peak velocity, and mean peak amplitude of head turns', 'frequency of head turns']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0560902', 'cui_str': 'Does turn head'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043388', 'cui_str': 'Yaws'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",28.0,0.0218172,"Velocity and amplitude of head turns during yaw and pitch gaze stability exercises did not significantly change.
","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Loyd', 'Affiliation': 'Department of Physical Therapy and Athletic Training, College of Health, University of Utah, Salt Lake City (B.J.L., J.S-S., A.F., P.B., L.D.); Department of Biomedical Engineering, College of Engineering, University of Utah, Salt Lake City (C.T.); and Department of Otolaryngology Head and Neck Surgery and Physical Medicine and Rehabilitation, School of Medicine, Johns Hopkins University, Baltimore, Maryland (M.S.).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Saviers-Steiger', 'Affiliation': ''}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Fangman', 'Affiliation': ''}, {'ForeName': 'Parker', 'Initials': 'P', 'LastName': 'Ballard', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Dibble', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000329']
1698,32815902,Factors Associated With Poor Linkage to Human Immunodeficiency Virus Care Among Index Clients and Sex Partners Receiving Human Immunodeficiency Virus Assisted Partner Services in Kenya.,"INTRODUCTION


Human immunodeficiency virus (HIV) assisted partner services (aPS) has been recommended as a strategy to increase HIV case finding. We evaluated factors associated with poor linkage to HIV care among newly diagnosed HIV-positive individuals (index clients) and their partners after receiving aPS in Kenya.
METHODS


In a cluster randomized trial conducted between 2013 and 2015, 9 facilities were randomized to immediate aPS (intervention). Linkage to care-defined as HIV clinic registration, and antiretroviral therapy (ART) initiation were self-reported. Antiretroviral therapy was only offered to those with CD4 less than 500 during this period. We estimated linkage to care and ART initiation separately for index clients and their partners using log-binomial generalized estimating equation models with exchangeable correlation structure and robust standard errors.
RESULTS


Overall, 550 index clients and 621 sex partners enrolled, of whom 46% (284 of 621) were HIV-positive. Of the 284, 264 (93%) sex partners returned at 6 weeks: 120 newly diagnosed and 144 whom had known HIV-positive status. Among the 120 newly diagnosed, only 69% (83) linked to care at 6 weeks, whereas among the 18 known HIV-positive sex partners not already in care at baseline, 61% (11) linked. Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all).
CONCLUSION


Only two thirds of newly diagnosed, and known HIV-positive sex partners not in care linked to care after receiving aPS. The HIV aPS programs should optimize HIV care for newly diagnosed HIV-positive sex partners, especially those who are younger and single.",2020,"Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all).
","['Of the 284, 264 (93%) sex partners returned at 6 weeks: 120 newly diagnosed and 144 whom had known HIV-positive status', '2013 and 2015, 9 facilities', 'Index Clients and Sex Partners', 'newly diagnosed HIV-positive individuals (index clients) and their partners after receiving aPS in Kenya', '120 newly diagnosed, only 69% (83) linked to care at 6 weeks, whereas among the 18 known HIV-positive sex partners not already in care at baseline, 61% (11) linked', '550 index clients and 621 sex partners enrolled, of whom 46% (284 of 621) were HIV-positive', 'Human Immunodeficiency Virus Care', 'Receiving Human Immunodeficiency Virus Assisted Partner Services in Kenya']","['immediate aPS (intervention', 'HIV aPS', 'Human immunodeficiency virus (HIV) assisted partner services (aPS', 'Antiretroviral therapy']",[],"[{'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],621.0,0.0547693,"Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all).
","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Wamuti', 'Affiliation': 'From the Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Marielle G', 'Initials': 'MG', 'LastName': 'Contesse', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Maingi', 'Affiliation': 'Voluntary Counseling and Testing (VCT) and HIV Prevention Unit, Kenyatta National Hospital.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Macharia', 'Affiliation': 'Kenya Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Abuna', 'Affiliation': 'From the Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Sambai', 'Affiliation': 'From the Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ngʼangʼa', 'Affiliation': 'Kenya Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Kelly Government Solutions, Contractor to Division of AIDS, PMPRB/Prevention Sciences Program, Division of AIDS, NIAID, NIH, Rockville, MD.'}, {'ForeName': 'Barbra', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'Departments of Biostatistics.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cherutich', 'Affiliation': 'Kenya Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bukusi', 'Affiliation': 'Voluntary Counseling and Testing (VCT) and HIV Prevention Unit, Kenyatta National Hospital.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001222']
1699,32827835,Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.,"AIM


The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.
METHODS


This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.
RESULTS


Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.
CONCLUSIONS


Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.
TRIAL REGISTRATION


Clinicaltrials. gov: NCT00378560 and NCT00411749.",2020,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"['female Japanese 4vHPV clinical trial participants', 'Japanese female clinical trial participants', 'Japanese young women aged 18-26 years (N\u202f=\u202f1021; NCT00378560) and girls aged 9-17 years (N\u202f=\u202f107; NCT00411749']","['vaccination with quadrivalent human papillomavirus vaccine', 'injection-site reactions', '4vHPV vaccine', 'quadrivalent human papillomavirus (4vHPV) vaccine', 'placebo']","['severe injection-site AEs', 'erythema, pain, pruritus, and swelling ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.597729,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Shirakawa', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: masayoshi.shirakawa@merck.com.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshie.sugawara@merck.com.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Shuto', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: michiko.shutou@merck.com.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: miyuki.sawata@merck.com.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshiyuki.tanaka@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100205']
1700,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
1701,32830894,Canakinumab to reduce deterioration of cardiac and respiratory function in SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury: The three C study).,"BACKGROUND


In patients with Covid-19, myocardial injury and increased inflammation are associated with morbidity and mortality. We designed a proof-of-concept randomized controlled trial to evaluate whether treatment with canakinumab prevents progressive respiratory failure and worsening cardiac dysfunction in patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation.
HYPOTHESIS


The primary hypothesis is that canakiumab will shorten time to recovery.
METHODS


The three C study (canakinumab in Covid-19 Cardiac Injury, NCT04365153) is a double-blind, randomized controlled trial comparing canakinumab 300 mg IV, 600 mg IV, or placebo in a 1:1:1 ratio in hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP). The primary endpoint is defined as the time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14 days postrandomization. The secondary endpoint is mortality at day 28. A total of 45 patients will be enrolled with an anticipated 5 month follow up period.
RESULTS


Baseline characteristics for the first 20 randomized patients reveal a predominantly male (75%), elderly population (median 67 years) with a high prevalence of hypertension (80%) and hyperlipidemia (75%). CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
CONCLUSIONS


The three C study will provide insights regarding whether IL-1β inhibition may improve outcomes in patients with SARS-CoV2 associated myocardial injury and increased inflammation.",2020,"CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
","['45 patients will be enrolled with an anticipated 5\u2009month follow up period', 'SARS-CoV-2 associated myocardial injury with heightened inflammation (canakinumab in Covid-19 cardiac injury', '20 randomized patients reveal a predominantly male (75%), elderly population (median 67\u2009years) with a high prevalence of hypertension (80%) and hyperlipidemia (75', 'hospitalized Covid-19 patients with elevations in troponin and C-reactive protein (CRP', 'patients with SARS-CoV2 infection, myocardial injury, and high levels of inflammation']","['canakinumab', 'canakinumab 300\u2009mg IV, 600\u2009mg IV, or placebo']","['progressive respiratory failure and worsening cardiac dysfunction', 'time in days from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever occurs first up to 14\u2009days postrandomization', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035229', 'cui_str': 'Respiratory insufficiency'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",45.0,0.334155,"CRPs have been markedly elevated (median 16.2 mg/dL) with modest elevations in high-sensitivity troponin T (median 21 ng/L), in keeping with the concept of enrolling patients with early myocardial injury.
","[{'ForeName': 'Calvin C', 'Initials': 'CC', 'LastName': 'Sheng', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Sahoo', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Dugar', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Robier Aguillon', 'Initials': 'RA', 'LastName': 'Prada', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Tom Kai Ming', 'Initials': 'TKM', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Ossama K', 'Initials': 'OK', 'LastName': 'Abou Hassan', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Brennan', 'Affiliation': 'C5 Research, Cleveland Clinic, Cleveland, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Culver', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Prabalini', 'Initials': 'P', 'LastName': 'Rajendram', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Duggal', 'Affiliation': 'Department of Pulmonary Medicine, Respiratory Institute, Cleveland, Ohio, USA.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Cremer', 'Affiliation': 'Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute Cleveland Clinic, Cleveland, Ohio, USA.'}]",Clinical cardiology,['10.1002/clc.23451']
1702,32830940,The Peritoneal Dialysis Transfer Set Replacement Procedure.,"Peritoneal dialysis transfer sets (extension lines) are replaced every six to nine months to minimize peritoneal dialysis catheter complications. The aim of this study was to compare a revised non-bag transfer set exchange procedure with the standard bag exchange procedure on nursing time, costs, and safety. Thirty-three people were randomized to two groups - a standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group (n = 17). The standard bag exchange procedure took a median of 32 minutes (interquartile range [IQR] 25 to 38 minutes) compared to the non-bag transfer set exchange procedure of 6 minutes (IQR 4 to 8 minutes) (p Ò 0.0001). There was one episode of peritonitis in each group within the 72-hour follow-up period. The average cost of the non-bag transfer set exchange procedure was $24.54 lower, a 37% cost reduction. This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.",2020,"This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.",['Thirty-three people'],"['standard bag exchange procedure group (n = 16) and a non-bag transfer set exchange procedure group', 'Peritoneal dialysis transfer sets (extension lines', 'standard bag exchange procedure']","['nursing time, costs, and safety', 'episode of peritonitis', 'average cost of the non-bag transfer set exchange procedure']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184030', 'cui_str': 'Transfer set'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0184030', 'cui_str': 'Transfer set'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",33.0,0.0246448,"This study has shown the revised non-bag transfer set replacement procedure appears to be safe, consume less participant and staff time, and decreases costs.","[{'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Funes', 'Affiliation': 'Former Center Manager, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Velasquez', 'Affiliation': 'Former Center Manager, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Doss-McQuitty', 'Affiliation': 'Director of Clinical Programs and Research, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Wael F', 'Initials': 'WF', 'LastName': 'Hussein', 'Affiliation': 'Senior Research Director, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Abra', 'Affiliation': 'Senior Medical Director, Satellite Healthcare, San Jose, CA. and Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.'}, {'ForeName': 'Pon', 'Initials': 'P', 'LastName': 'Anantiyo', 'Affiliation': 'Vice President of Home Services, Satellite Healthcare, San Jose, CA.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Bennett', 'Affiliation': 'Director of Research, Satellite Healthcare, San Jose, CA; an Honorary Professor of Nursing, Faculty of Health, Deakin University. Melbourne, Australia.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Schiller', 'Affiliation': 'Chief Medical Officer, Satellite Healthcare, San Jose, CA; and an Adjunct Lecturer, Division of Nephrology, Department of Medicine, Stanford University School of Medicine Stanford University, Palo Alto, CA.'}]",Nephrology nursing journal : journal of the American Nephrology Nurses' Association,[]
1703,32836201,Development and validation of a nomogram for predicting survival of advanced breast cancer patients in China.,"BACKGROUND


There is a lack of prognostic models predicting the overall survival (OS) of advanced breast cancer (ABC) patients in China.
METHODS


Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants were enrolled in this study, which were further randomized 3:1 and divided into training (n = 1706) and validation (n = 557) groups. The nomogram was built based on independent predictors identified by univariate and multivariate cox regression analyses. The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
RESULTS


Univariate and multivariate analyses found that age, Eastern Cooperative Oncology Group (ECOG) score, T-stage, N-stage, tumor subtype, the presence of distant lymph node (DLN)/liver/brain metastasis, local therapy, efficacy of first-line therapy and metastatic-free interval (MFI) were significantly related to OS (all P < 0.05). These variables were incorporated into a nomogram to predict the 2-year and 3-year OS of ABC patients. The C-indexes of the nomogram were 0.700 (95% confidence interval [CI]: 0.683-0.717) for the training set and 0.686 (95% CI: 0.652-0.719) for the validation set. The calibration curves revealed satisfactory consistency between actual survival and nomogram prediction in both the internal and external validations. The nomogram was capable of stratifying patients into different risk cohorts.
CONCLUSIONS


We constructed and validated a nomogram that might serve as an efficient tool to provide prognostic prediction for ABC patients and guide the physicians to make personalized treatment decisions.",2020,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","['advanced breast cancer patients in China', 'Data from the China National Cancer Center database that recorded 4039 patients diagnosed with breast cancer between 1987 and 2019 were extracted and a total of 2263 ABC participants', 'advanced breast cancer (ABC) patients in China']",[],['overall survival (OS'],"[{'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0456591', 'cui_str': '1987'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",4039.0,0.0279926,"The discriminatory and predictive capacities of the nomogram were assessed by Harrell's concordance index (C-index) and calibration plots.
","[{'ForeName': 'Shaoyan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Hongnan', 'Initials': 'H', 'LastName': 'Mo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yiqun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Xiuwen', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Department of VIP Medical Services, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Ruigang', 'Initials': 'R', 'LastName': 'Cai', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China.'}, {'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, PR China. Electronic address: xubinghe@medmail.com.cn.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.004']
1704,32836563,Reframing Time Spent Alone: Reappraisal Buffers the Emotional Effects of Isolation.,"Background


Loneliness, a transdiagnostic feature of psychopathology, is an experience of perceived isolation only weakly linked to the amount of time spent alone. Although traditional loneliness interventions aim to increase social contact, targeting maladaptive cognition about time alone may be an effective way to reduce loneliness. We investigated whether a brief reappraisal manipulation enables individuals to experience their time alone more positively. We also tested the impact of trait loneliness, compulsive social media use, and trait reappraisal on experiences of time alone.
Methods


College students and community members ( N  = 220) were randomly assigned to read a passage about the benefits of solitude ( n  = 74), the true prevalence of loneliness ( n  = 72), or a control topic ( n  = 74). Participants then sat alone for 10 min.
Results


Across conditions, positive and negative mood significantly decreased after sitting alone. Participants who read about the benefits of solitude experienced a smaller reduction in positive mood than those in the control condition. Participants who less frequently used reappraisal in their everyday lives benefited most from the manipulation.
Conclusions


Our results provide preliminary evidence that reappraising time alone as solitude may boost resilience to the decrements in positive mood associated with time alone. Limitations, clinical implications, and directions for future research are discussed.",2020,Participants who read about the benefits of solitude experienced a smaller reduction in positive mood than those in the control condition.,['Methods\n\n\nCollege students and community members ( N \u2009=\u2009220'],['reappraisal manipulation'],[],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],220.0,0.0447612,Participants who read about the benefits of solitude experienced a smaller reduction in positive mood than those in the control condition.,"[{'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Bellet', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McNally', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA USA.'}]",Cognitive therapy and research,['10.1007/s10608-020-10128-x']
1705,32836837,Linking Human Destruction of Nature to COVID-19 Increases Support for Wildlife Conservation Policies.,"This paper investigates if narratives varying the cause of the COVID-19 pandemic affects pro-wildlife conservation outcomes. In a pre-registered online experiment (N = 1081), we randomly allocated subjects to either a control group or to one of three narrative treatment groups, each presenting a different likely cause of the COVID-19 outbreak: an animal cause; an animal and human cause (AHC); and an animal, human or lab cause. We found that the AHC narrative elicited significantly greater pro-conservation policy support, especially for bans in the commercial trade of wildlife, when compared to the control group. Possible mechanisms driving this effect are that AHC narratives were less familiar, elicited higher mental and emotional engagement, and induced feelings that firms and governments are responsible for mitigating wildlife extinction.",2020,"We found that the AHC narrative elicited significantly greater pro-conservation policy support, especially for bans in the commercial trade of wildlife, when compared to the control group.",[],[],[],[],[],[],,0.0243312,"We found that the AHC narrative elicited significantly greater pro-conservation policy support, especially for bans in the commercial trade of wildlife, when compared to the control group.","[{'ForeName': 'Ganga', 'Initials': 'G', 'LastName': 'Shreedhar', 'Affiliation': 'London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Mourato', 'Affiliation': 'London School of Economics and Political Science, London, UK.'}]",Environmental & resource economics,['10.1007/s10640-020-00444-x']
1706,32837131,How does brief guided mindfulness meditation enhance empathic concern in novice meditators?: A pilot test of the suggestion hypothesis vs. the mindfulness hypothesis.,"Despite the widespread popularity of mindfulness meditation for its various benefits, the mechanism underlying the meditation process has rarely been explored. Here, we present two preliminary studies designed to test alternative hypotheses: whether the effect of brief guided mindfulness meditation on empathic concern arises from verbal suggestion (suggestion hypothesis) or as a byproduct of an induced mindfulness state (mindfulness hypothesis). Study 1 was a pilot randomized control trial of sitting (breath-and-body) meditation vs. compassion meditation that provided preliminary support for the mindfulness hypothesis. Study 2 was set up to rule out the possibility that the meditation effects observed in Study 1 were the effects of repeated measures. An inactive control group of participants underwent the repeated measures of empathic concern with no meditation in between. The pre-post comparison demonstrated no significant changes in the measures. Thus, the results of two studies supported the mindfulness hypothesis. Limitations of the present study and future research directions are discussed.",2020,The pre-post comparison demonstrated no significant changes in the measures.,[],"['guided mindfulness meditation', 'sitting (breath-and-body) meditation vs. compassion meditation']",[],[],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",[],,0.012488,The pre-post comparison demonstrated no significant changes in the measures.,"[{'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Miyahara', 'Affiliation': 'Department of Clinical Psychological Science, School of Medicine, Hirosaki University, 66-1, Hon-cho, Hirosaki, Aomori 036-8564 Japan.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027 Australia.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Pocock', 'Affiliation': 'School of Nursing, University of Auckland, Building 505, Level 2, 85 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'College of Letters, Ritsumeikan University, 56-1 Tojiin-kita-machi, Kita-ku, Kyoto, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fukuhara', 'Affiliation': 'College of Letters, Ritsumeikan University, 56-1 Tojiin-kita-machi, Kita-ku, Kyoto, Japan.'}]","Current psychology (New Brunswick, N.J.)",['10.1007/s12144-020-00881-3']
1707,32837162,Crime Rates in a Pandemic: the Largest Criminological Experiment in History.,"The COVID-19 pandemic of 2020 has impacted the world in ways not seen in generations. Initial evidence suggests one of the effects is crime rates, which appear to have fallen drastically in many communities around the world. We argue that the principal reason for the change is the government ordered stay-at-home orders, which impacted the routine activities of entire populations. Because these orders impacted countries, states, and communities at different times and in different ways, a naturally occurring, quasi-randomized control experiment has unfolded, allowing the testing of criminological theories as never before. Using new and traditional data sources made available as a result of the pandemic criminologists are equipped to study crime in society as never before. We encourage researchers to study specific types of crime, in a temporal fashion (following the stay-at-home orders), and placed-based. The results will reveal not only why, where, when, and to what extent crime changed, but also how to influence future crime reduction.",2020,"Initial evidence suggests one of the effects is crime rates, which appear to have fallen drastically in many communities around the world.",[],[],['Crime Rates'],[],[],"[{'cui': 'C0010325', 'cui_str': 'Crime'}]",,0.0228332,"Initial evidence suggests one of the effects is crime rates, which appear to have fallen drastically in many communities around the world.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Stickle', 'Affiliation': 'Department of Criminal Justice Administration, Middle Tennessee State University, Murfreesboro, TN 37132 USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Felson', 'Affiliation': 'Texas State University, San Marcos, TX USA.'}]",American journal of criminal justice : AJCJ,['10.1007/s12103-020-09546-0']
1708,32837750,The Efficacy and Safety of Triazavirin for COVID-19: A Trial Protocol.,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups: standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treatment of COVID-19.",2020,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019.","['240 participants with COVID-19 are scheduled to be enrolled in this trial', 'COVID-19 patients', 'Participants with positive tests of throat swab virus nucleic acid']","['placebo', 'Triazavirin (TZV', 'Triazavirin for COVID-19', 'standard therapy plus TZV or standard therapy plus placebo']","['clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflammatory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients', 'Adverse events, serious adverse events, liver function, kidney function', 'time to clinical improvement of the subjects']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2714695', 'cui_str': 'triazavirin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",240.0,0.261526,"The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019.","[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Kaijiang', 'Initials': 'K', 'LastName': 'Yu', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yongchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Wanhai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Benzhi', 'Initials': 'B', 'LastName': 'Cai', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'The Fourth Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Heilongjiang Provincial Hospital, Harbin Institute of Technology, Harbin 150030, China.'}, {'ForeName': 'Jingshu', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Huichao', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'The First Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Du', 'Affiliation': 'The Second Affiliated Hospital, Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'Baofeng', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'College of Pharmacology, Harbin Medical University, Harbin 150001, China.'}]","Engineering (Beijing, China)",['10.1016/j.eng.2020.06.011']
1709,32837953,CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy in type 1 diabetes.,"Background


Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy. Freely available open-source algorithms, which have the ability to individualise algorithm parameters paired with commercial insulin pumps, and continuous glucose monitoring make up the so-called ""do it yourself"" (DIY) approach to AID. Limited data on the open-source approach have shown promising results, but data from a large randomised control trial are lacking.
Methods


The CREATE (Community deRivEd AutomaTEd insulin delivery) trial is an open-labelled, randomised, parallel 24-week, multi-site trial comparing sensor augmented pump therapy (SAPT) to our AnyDANA-loop. The three components of AnyDANA-loop are: 1) OpenAPS algorithm implemented in a smartphone (a version of AndroidAPS), 2) DANA-i™ insulin pump and, 3) Dexcom G6 R  continuous glucose monitor (CGM). The primary outcome measure is the percentage of time in target sensor glucose range (3.9 -10mmol/L). Secondary outcomes include psycho-social factors and platform performance. Analysis of online collective learning, characteristic of the open-source approach, is planned. 100 participants with T1D aged 7 - 70 years (age stratified into children/adolescents 7-15 years and adults 16-70 years), will be recruited from four sites in New Zealand. A 24-week continuation phase follows, to assess long-term safety.",2020,"Background


Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy.","['100 participants with T1D aged 7 - 70 years (age stratified into children/adolescents 7-15 years and adults 16-70 years', 'type 1 diabetes']","['automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy', 'smartphone (a version of AndroidAPS), 2) DANA-i™ insulin pump and, 3) Dexcom G6 R  continuous glucose monitor (CGM', 'sensor augmented pump therapy (SAPT', '\n\n\nCommercialised automated insulin delivery (AID) systems']","['psycho-social factors and platform performance', 'percentage of time in target sensor glucose range (3.9 -10mmol/L']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0337460', 'cui_str': 'Social factor'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517698', 'cui_str': '3.9'}]",100.0,0.196103,"Background


Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Burnside', 'Affiliation': 'Department of Paediatrics, University of Otago, 2 Riccarton Avenue, Christchurch, 8011 New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'OpenAPS, Seattle, WA USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Crocket', 'Affiliation': 'Te Huataki Waiora School of Health, Sport & Human Performance, University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': 'Department of Paediatrics, University of Otago, 2 Riccarton Avenue, Christchurch, 8011 New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Williman', 'Affiliation': 'Department of Population Health, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Department of Paediatric Endocrinology, Starship Children's Hospital, Auckland District Health Board, Auckland, New Zealand.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Waikato Regional Diabetes Service, Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Wheeler', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'de Bock', 'Affiliation': 'Department of Paediatrics, University of Otago, 2 Riccarton Avenue, Christchurch, 8011 New Zealand.'}]",Journal of diabetes and metabolic disorders,['10.1007/s40200-020-00547-8']
1710,32838353,Efficacy and Safety of Lopinavir/Ritonavir or Arbidol in Adult Patients with Mild/Moderate COVID-19: An Exploratory Randomized Controlled Trial.,"Background


Antiviral therapies against the novel coronavirus SARS-CoV-2, which has caused a global pandemic of respiratory illness called COVID-19, are still lacking.
Methods


Our study (ClinicalTrials.gov: NCT04252885, named ELACOI), was an exploratory randomized (2:2:1) controlled trial assessing the efficacy and safety of lopinavir/ritonavir (LPV/r) or arbidol monotherapy for treating patients with mild/moderate COVID-19.
Findings


This study successfully enrolled 86 patients with mild/moderate COVID-19, with 34 randomly assigned to receive LPV/r, 35 to arbidol, and 17 with no antiviral medication as control. Baseline characteristics of the three groups were comparable. The primary endpoint, the rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid, was similar between groups (all p > 0.05). There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05). At day 7, 8 (23.5%) patients in the LPV/r group, 3 (8.6%) in the arbidol group, and 2 (11.8%) in the control group showed a deterioration in clinical status from moderate to severe/critical (p = 0.206). Overall, 12 (35.3%) patients in the LPV/r group and 5 (14.3%) in the arbidol group experienced adverse events during the follow-up period. No apparent adverse event occurred in the control group.
Conclusions


LPV/r or arbidol monotherapy present little benefit for improving the clinical outcome of patients hospitalized with mild/moderate COVID-19 over supportive care.
Funding


This study was supported by project 2018ZX10302103-002, 2017ZX10202102-003-004, and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021).",2020,"There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05).","['patients with mild/moderate COVID-19', 'project 2018ZX10302103-002, 2017ZX10202102-003-004, and Infectious Disease Specialty of Guangzhou High-level Clinical Key Specialty (2019-2021', 'Adult Patients with Mild/Moderate COVID-19', 'patients hospitalized with mild/moderate COVID-19 over supportive care', '86 patients with mild/moderate COVID-19, with 34 randomly assigned to receive LPV/r, 35 to arbidol, and 17 with no antiviral medication as control']","['Lopinavir/Ritonavir or Arbidol', 'lopinavir/ritonavir (LPV/r) or arbidol monotherapy']","['efficacy and safety', 'adverse events', 'Efficacy and Safety', 'rate of positive-to-negative conversion of SARS-CoV-2 nucleic acid', 'rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT', 'adverse event']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C1273849', 'cui_str': 'Infectious diseases (specialty)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0877252', 'cui_str': 'Antipyresis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",86.0,0.125277,"There were no differences between groups in the secondary endpoints, the rates of antipyresis, cough alleviation, or improvement of chest computed tomography (CT) at days 7 or 14 (all p > 0.05).","[{'ForeName': 'Yueping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Weiyin', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Xiaoneng', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': ""Department of Respiration, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Peng', 'Affiliation': ""Department of Respiration, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Xudan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Jinxin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Lieguang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiology, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Fengyu', 'Initials': 'F', 'LastName': 'Hu', 'Affiliation': ""Institute of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Institute of Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Fuchun', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}, {'ForeName': 'Xilong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Intensive Care Unit, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510440, China.""}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou 510060, China.""}]","Med (New York, N.Y.)",['10.1016/j.medj.2020.04.001']
1711,32838647,Pharmacogenomics and pharmacokinetics of efavirenz 400 or 600 mg in 184 treatment-naive HIV-infected patients in China.,"Background:  The pharmacogenomics and pharmacokinetics/pharmacodynamics of 400 mg efavirenz have rarely been reported.  Materials & methods:  A total of 184 treatment-naive HIV-infected patients were randomly assigned (1:1) to receive a lower dose (tenofovir disoproxil 200 mg, efavirenz 400 mg and lamivudine) or a standard dose regimen. Relationships between pharmacogenomics and efavirenz pharmacokinetics/pharmacodynamics were explored at 48 weeks.  Results:  There was no relationship between pharmacogenomics and adverse reactions of the central nervous system and antiretoviral efficacy.  CYP2B6 516G>T ,  785A>G ,  18492C>T  and ABCB1  3435C>T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower dose group. No relationship was found between pharmacogenomics and antiretoviral efficacy. Patients who were <60 kg had higher efavirenz concentration compared with those with weight ≥60 kg when using 600 mg efavirenz, this was not observed with 400 mg efavirenz.  Conclusion:  The effect of pharmacogenomics and body weight on the efavirenz concentration was significant in the 600 mg group but not in the 400 mg group.",2020,T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group.,"['184 treatment-naive HIV-infected patients in China', 'A total of 184 treatment-naive HIV-infected patients']","['lower dose (tenofovir disoproxil 200\xa0mg, efavirenz 400\xa0mg and\xa0lamivudine', 'efavirenz']","['efavirenz plasma levels', 'T  and ABCB1  3435C', 'efavirenz concentration']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0963398', 'cui_str': 'tenofovir disoproxil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4555930', 'cui_str': 'efavirenz 400 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0548373,T  T/C were associated with higher efavirenz plasma levels in the standard but not the lower-dose group.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Jingna', 'Initials': 'J', 'LastName': 'Xun', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Zhiliang', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Infectious Disease, The Second Hospital of Nanjing, Nanjing University of Chinese Medicine, Nanjing, 210003, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Yunnan AIDS Care Center (YNACC), Yunnan Provincial Infectious Disease Hospital, Kunming, 650500, China.'}, {'ForeName': 'Renfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Corky', 'Initials': 'C', 'LastName': 'Steinhart', 'Affiliation': 'CAN Community Health, FL 34232, USA.'}, {'ForeName': 'Yinzhong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Infection & Immunology, Shanghai Public Health Clinical Center, Fudan University. Shanghai, 201508, China.'}]",Pharmacogenomics,['10.2217/pgs-2019-0169']
1712,32791322,The Aging PLUS  trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults.,"BACKGROUND


Negative views of aging (NVOA), low self-efficacy beliefs, and poor goal planning skills represent risk factors that undermine adults' motivation to engage in physical activity (PA). Targeting these three risk factors may motivate adults to become physically active.
OBJECTIVE


To assess the efficacy of Aging PLUS , a 4-week educational program that explicitly targets NVOA, low self-efficacy beliefs, and poor goal planning skills compared to a 4-week health education program. The study also examines the role of NVOA, self-efficacy beliefs, and goal planning as the mechanisms underlying change in PA.
DESIGN


This randomized controlled trial (RCT) utilizes the experimental medicine approach to assess change in PA as a function of modifying three risk factors. The RCT recruitment target includes 288 mostly sedentary adults ranging in age from 45 to 75 years.
METHODS


Eligible middle-aged and older adults are recruited through community sources. Participants are randomized to either the Aging PLUS  or the control group. Participants in both groups are enrolled in the trial for 8 months total, with four assessment points: Baseline (pre-test), Week 4 (immediate post-test), Week 8 (delayed post-test), and Month 6 (long-term follow-up). The intervention takes place over 4 consecutive weeks with 2-h sessions each week. PA engagement is the primary outcome variable. Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
SUMMARY


By utilizing a multi-component approach and targeting a cluster of psychological mechanisms, the Aging PLUS  program implements the experimental medicine approach to health behavior change.",2020,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","['middle-aged and older adults', '288 mostly sedentary adults ranging in age from 45 to 75\u202fyears', 'Eligible middle-aged and older adults']",[],"['physical activity', 'Positive changes in NVOA, self-efficacy beliefs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",288.0,0.0622321,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Diehl', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States. Electronic address: manfred.diehl@colostate.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Nehrkorn-Bailey', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bland', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Feltner', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Forsyth', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hulett', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Berkeley', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Mars', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mast', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Monasterio', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'Schoenberg', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomson', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Tseng', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106105']
1713,32795903,Ventilatory support during whole-body row training improves oxygen uptake efficiency in patients with high-level spinal cord injury: A pilot study.,"High-level spinal cord injury (SCI) is characterized by profound respiratory compromise. One consequence is a limitation of whole-body exercise-based rehabilitation, reducing its cardioprotective effect. We investigated the use of ventilatory support during training on cardiorespiratory response to exercise. Nine subjects with high-level SCI (T3-C4) were included in this double-blind sham-controlled study. All had training adaptations plateauing for more than 6 months before enrolling in the study. After performing baseline assessment, participants were randomly assigned to continue training with non-invasive ventilation (NIV: n = 6: IPAP = 20 ± 2, EPAP: 3 cmH 2 O) or sham (n = 3: IPAP = 5, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests. We compared the oxygen uptake efficiency slope (OUES, the rate of increases in VO 2  in relation to increasing VE) before and after training. Training with NIV increased OUES both compared to baseline (4.1 ± 1.1 vs. 3.4 ± 1.0, i.e. +20 ± 12%, p < 0.05) and Sham (p = 0.01), representing an increase in ability to uptake oxygen for a given ventilation. This result was sustained without NIV during the test, suggesting improved cardiopulmonary reserve. Best responders were the youngest whose characteristics were very similar to sham participants. In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham). Our results are very suggestive of a positive effect of ventilatory support during whole-body exercise in high-level SCI. Training adaptations found are of great importance since this sub-population of patients have the greatest need for exercise-based cardio-protection.",2020,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","['Nine subjects with high-level SCI (T3-C4', 'patients with high-level spinal cord injury']","['continue training with non-invasive ventilation (NIV: n\xa0=\xa06: IPAP\xa0=\xa020\xa0±\xa02, EPAP: 3 cmH 2 O) or sham (n\xa0=\xa03: IPAP\xa0=\xa05, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests', 'Ventilatory support during whole-body row training']","['oxygen uptake efficiency', 'weekly rowing distance', 'ability to uptake oxygen', 'oxygen uptake efficiency slope (OUES']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",9.0,0.0857854,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, 75013, Paris, France. Electronic address: isabelle.vivodtzev@sorbonne.universite.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106104']
1714,32804132,Effects of Resistance Exercise with Instability on Cognitive Function (REI Study): A Proof-Of-Concept Randomized Controlled Trial in Older Adults with Cognitive Complaints.,"BACKGROUND


Activities which simultaneously challenge both physical and cognitive function are promising strategies for promoting cognitive function.
OBJECTIVE


To examine the effects of resistance exercise with instability and traditional resistance exercise compared with a health education control on cognitive function in older adults with cognitive complaints.
METHODS


Sixty-seven participants were randomized to either 12 weeks of thrice-weekly resistance exercise (RE = 23), RE with instability (REI = 22), or a weekly health education control (CON = 22). At each training session, RE and REI participants performed seven exercises for three sets and 10-15 repetitions. REI participants performed each exercise using instability devices. The primary outcome was a composite score of global cognitive function. Secondary outcomes included composite scores for cognitive sub-domains and physical function.
RESULTS


Most participants were women (REI: 77%; RE = 78%; CON = 77%; mean age of 71 years), and did not need transport to the intervention site. At completion, compared with CON, REI and RE did not significantly improve on global cognition or each cognitive sub-domain. Both exercise groups improved on the timed up and go (REI - CON: -1.6 s, 95% CI: [-2.6, -0.5]; RE - CON: -1.4 s, 95% CI: [-2.4, -0.5) and 1-RM (REI - CON: 24 kg, 95% CI: [11, 36]; RE - CON: 25 kg, 95% CI: [12, 37]). An exploratory contrast showed that compared with RE, REI promote greater gains on global cognition (2.20, 95% CI: [0.10, 4.31]) and memory (1.34; 95% CI: [0.15, 2.54]).
CONCLUSION


REI did not substantially improve cognitive function but did promote physical function among older adults with cognitive complaints. However, compared with RE, REI improved global cognition and memory.",2020,"At completion, compared with CON, REI and RE did not significantly improve on global cognition or each cognitive sub-domain.","['Older Adults with Cognitive Complaints', 'Most participants were women (REI: 77%; RE\u200a=\u200a78%; CON\u200a=\u200a77%; mean age of 71 years', 'Sixty-seven participants', 'older adults with cognitive complaints']","['REI', 'thrice-weekly resistance exercise (RE\u200a=\u200a23), RE with instability ', 'RE, REI', 'Resistance Exercise', 'RE - CON', 'CON, REI and RE', 'timed up and go (REI - CON', 'resistance exercise with instability and traditional resistance exercise', 'REI - CON', 'health education control']","['1-RM', 'global cognition', 'cognitive function', 'composite scores for cognitive sub-domains and physical function', 'global cognition and memory', 'composite score of global cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",67.0,0.122258,"At completion, compared with CON, REI and RE did not significantly improve on global cognition or each cognitive sub-domain.","[{'ForeName': 'Bruno Remígio', 'Initials': 'BR', 'LastName': 'Cavalcante', 'Affiliation': 'Associated Graduate Program in Physical Education UPE/UFPB, University of Pernambuco, Recife-PE, Brazil.'}, {'ForeName': 'Mariana Ferreira', 'Initials': 'MF', 'LastName': 'de Souza', 'Affiliation': 'Post-graduate Program in Physical Education, Federal University of Vale do São Francisco, Petrolina-PE, Brazil.'}, {'ForeName': 'Ryan Stanley', 'Initials': 'RS', 'LastName': 'Falck', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, Canada.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland St. John's, NL, Canada.""}, {'ForeName': 'Ana Carolina Rodarti', 'Initials': 'ACR', 'LastName': 'Pitangui', 'Affiliation': 'Laboratório de Pesquisa em Saúde e Desempenho Funcional (LABSED), University of Pernambuco, Petrolina-PE, Brazil.'}, {'ForeName': 'Rodrigo Cappato', 'Initials': 'RC', 'LastName': 'de Araújo', 'Affiliation': 'Laboratório de Pesquisa em Saúde e Desempenho Funcional (LABSED), University of Pernambuco, Petrolina-PE, Brazil.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200349']
1715,32804188,Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial.,"Importance


Morphine is used as palliative treatment of chronic breathlessness in patients with advanced chronic obstructive pulmonary disease (COPD). Evidence on respiratory adverse effects and health status is scarce and conflicting.
Objective


To assess the effects of regular, low-dose, oral sustained-release morphine on disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness in patients with COPD.
Interventions


Participants were randomly assigned to 10 mg of regular, oral sustained-release morphine or placebo twice daily for 4 weeks, with the possibility to increase to 3 times daily after 1 or 2 weeks.
Design, Setting, and Participants


The Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC) study was a randomized, double-blind, and placebo-controlled study of a 4-week intervention. Patients were enrolled between November 1, 2016, and January 24, 2019. Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program. Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4) despite optimal pharmacological and nonpharmacological treatment were included. A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate.
Main Outcomes and Measures


Primary outcomes were CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2). Secondary outcome was breathlessness in the previous 24 hours (numeric rating scale). Data were analyzed by intention to treat. Subgroup analyses in participants with mMRC grades 3 to 4 were performed.
Results


A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54%]). Difference in CAT score was 2.18 points lower in the morphine group (95% CI, -4.14 to -0.22 points; P = .03). Difference in Paco2 was 1.19 mm Hg higher in the morphine group (95% CI, -2.70 to 5.07 mm Hg; P = .55). Breathlessness remained unchanged. Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03). Five participants of 54 in the morphine group (9%) and 1 participant of 57 in the placebo group (2%) withdrew because of adverse effects. No morphine-related hospital admissions or deaths occurred.
Conclusions and Relevance


In this randomized clinical trial, regular, low-dose, oral sustained-release morphine for 4 weeks improved disease-specific health status in patients with COPD without affecting Paco2 or causing serious adverse effects. The worst breathlessness improved in participants with mMRC grades 3 to 4. A larger randomized clinical trial with longer follow-up in patients with mMRC grades 3 to 4 is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02429050.",2020,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","['Patients With COPD (MORDYC', 'A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54', 'patients with COPD without affecting Paco2 or causing serious adverse effects', 'Patients were enrolled between November 1, 2016, and January 24, 2019', 'participants with mMRC grades 3 to 4 were performed', 'Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4', 'patients with COPD', 'A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate', 'patients with advanced chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease on Health Status', 'patients with mMRC grades 3 to 4 is warranted', 'Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program']","['regular, oral sustained-release morphine or placebo', 'morphine', 'oral sustained-release morphine', 'regular, low-dose, oral sustained-release morphine', 'Morphine', 'Sustained-Release Morphine', 'placebo']","['Worst breathlessness', 'adverse effects', 'CAT score', 'Breathlessness', 'Difference in Paco2', 'CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2', 'worst breathlessness', 'hospital admissions or deaths occurred', 'disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness', 'disease-specific health status', 'breathlessness in the previous 24 hours (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1380.0,0.443493,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","[{'ForeName': 'Cornelia A', 'Initials': 'CA', 'LastName': 'Verberkt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke H J', 'Initials': 'MHJ', 'LastName': 'van den Beuken-van Everdingen', 'Affiliation': 'Centre of Expertise for Palliative Care, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hameleers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research & Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.3134']
1716,32799565,Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects.,"OBJECTIVE


The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet versus a brand-named empagliflozin tablet (Jardiance ® ) and evaluate the food effects on the pharmacokinetics (PK) of empagliflozin in healthy Chinese subjects.
METHODS


Forty-eight healthy volunteers were included in this randomized, open-label, crossover, two-period study (fasting:  n  = 24, fed:  n  = 24). A single dose of 25-mg generic (or test) or brand-named (or reference) empagliflozin was administered to each subject in a randomized sequence. Blood samples were collected at the baseline and during the 72 h post-dose, and plasma empagliflozin concentrations were determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Pharmacokinetic parameters were analyzed with non-compartmental methods. Safety was monitored.
RESULTS


The major PK parameters including  C   max , AUC 0-   t  , and AUC 0-∞  were similar between the generic and brand-named tablets under fasting and fed conditions (all  p  > .05). The 90% confidence intervals of the test/reference ratios of log-transformed  C   max , AUC 0-   t  , and AUC 0-∞  were 94.90-106.70%, 100.62-106.99%, and 100.64-106.85%, respectively, under fasting condition, and 94.21-104.91%, 97.31-101.79%, and 97.32-101.83%, respectively, under fed condition. High-fat food did not affect  C   max , AUC 0-   t  , AUC 0-∞ , or  T   max  of empagliflozin (all  p  > .05). There was no serious adverse event during the study period.
CONCLUSION


The generic formulation of empagliflozin tablet is bioequivalent to the brand-named product in healthy Chinese volunteers, and well tolerated. High-fat food had no effects on the PK of empagliflozin in healthy Chinese volunteers.",2020,"High-fat food did not affect C max , AUC 0-t ,","['Methods:  Forty-eight healthy volunteers', 'healthy Chinese subjects', 'healthy Chinese volunteers']","['empagliflozin', 'generic empagliflozin', 'generic empagliflozin tablet  versus  a brand-named empagliflozin tablet (Jardiance®', '25-mg generic (or test) or brand-named (or reference) empagliflozin', 'empagliflozin ']","['tolerated', 'Blood samples', 'C max , AUC 0-t ', 'plasma empagliflozin concentrations', 'reference ratios of log-transformed C max , AUC 0-t  and AUC 0-∞', 'C max , AUC 0-t  and AUC 0-∞']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C3848959', 'cui_str': 'empagliflozin Oral Tablet'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C3848669', 'cui_str': 'Jardiance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.0296417,"High-fat food did not affect C max , AUC 0-t ,","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, People's Republic of China.""}]",Drug development and industrial pharmacy,['10.1080/03639045.2020.1810263']
1717,32800099,"Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial.","BACKGROUND


The appropriate age range for breast cancer screening remains a matter of debate. We aimed to estimate the effect of mammographic screening at ages 40-48 years on breast cancer mortality.
METHODS


We did a randomised, controlled trial involving 23 breast screening units across Great Britain. We randomly assigned women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen at approximately age 50 years (control group). Women in the intervention group were recruited by postal invitation. Women in the control group were unaware of the study. The primary endpoint was mortality from breast cancers (with breast cancer coded as the underlying cause of death) diagnosed during the intervention period, before the participant's first NHSBSP screen. To study the timing of the mortality effect, we analysed the results in different follow-up periods. Women were included in the primary comparison regardless of compliance with randomisation status (intention-to-treat analysis). This Article reports on long-term follow-up analysis. The trial is registered with the ISRCTN registry, ISRCTN24647151.
FINDINGS


160 921 women were recruited between Oct 14, 1990, and Sept 24, 1997. 53 883 women (33·5%) were randomly assigned to the intervention group and 106 953 (66·5%) to the control group. Between randomisation and Feb 28, 2017, women were followed up for a median of 22·8 years (IQR 21·8-24·0). We observed a significant reduction in breast cancer mortality at 10 years of follow-up, with 83 breast cancer deaths in the intervention group versus 219 in the control group (relative rate [RR] 0·75 [95% CI 0·58-0·97]; p=0·029). No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
INTERPRETATION


Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality.
FUNDING


National Institute for Health Research Health Technology Assessment programme.",2020,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","['from age 40 years on breast cancer mortality (UK Age trial', '160\u2008921 women were recruited between Oct 14, 1990, and Sept 24, 1997', '23 breast screening units across Great Britain', 'at ages 40-48 years on breast cancer mortality', 'women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to', '53\u2008883 women (33·5']","['mammographic screening', 'standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen']","['breast cancer mortality', 'mortality from breast cancers (with breast cancer coded as the underlying cause of death', 'mortality effect']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456586', 'cui_str': 'Calendar year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",23.0,0.112667,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","[{'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. Electronic address: s.w.duffy@qmul.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cuckle', 'Affiliation': 'Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Division of Cancer Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Blyuss', 'Affiliation': 'School of Physics, Astronomy, and Mathematics, University of Hertfordshire, Hatfield, UK; Department of Paediatrics and Paediatric Infectious Diseases, Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Ian O', 'Initials': 'IO', 'LastName': 'Ellis', 'Affiliation': 'Division of Cancer and Stem Cells, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myles', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30398-3']
1718,32801342,L-DOPA and consolidation of fear extinction learning among women with posttraumatic stress disorder.,"This study tested whether L-DOPA delivered during the consolidation window following fear extinction learning reduces subsequent fear responding among women with PTSD. Adult women diagnosed with PTSD completed a contextual fear acquisition and extinction task during fMRI and then immediately received either placebo (n = 34), 100/25 mg L-DOPA/carbidopa (n = 28), or 200/50 mg L-DOPA/carbidopa (n = 29). Participants completed a resting-state scan before the task and again 45 min following drug ingestion to characterize effects of L-DOPA on extinction memory neural reactivation patterns during consolidation. Twenty-four hours later, participants returned for tests of context renewal, extinction recall, and reinstatement during fMRI with concurrent skin conductance responding (SCR) assessment. Both active drug groups demonstrated increased reactivation of extinction encoding in the amygdala during the post-task resting-state scan. For SCR data, both drug groups exhibited decreased Day 2 reinstatement across all stimuli compared to placebo, and there was some evidence for decreased context renewal to the fear stimulus in the 100 mg group compared to placebo. For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo. There was no evidence in SCR or neural activity that L-DOPA improved extinction recall. Reactivation of extinction encodings in the amygdala during consolidation on Day 1 predicted Day 2 activation of the insula network. These results support a role for dopamine during the consolidation window in boosting reactivation of amygdala extinction encodings and reducing reinstatement, but not improving extinction recall, in women with PTSD.",2020,"For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo.","['women with PTSD', 'Adult women diagnosed with PTSD completed a contextual fear acquisition and extinction task during fMRI and then immediately received either', 'women with posttraumatic stress disorder']","['200/50\u2009mg L-DOPA/carbidopa', 'L-DOPA', '100/25\u2009mg L-DOPA/carbidopa', 'L-DOPA and consolidation of fear extinction learning', 'placebo']","['reactivation of extinction encoding', 'SCR or neural activity that L-DOPA improved extinction recall']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0800658,"For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo.","[{'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Cisler', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA. jcisler2@wisc.edu.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Privratsky', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Anneliis', 'Initials': 'A', 'LastName': 'Sartin-Tarm', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Kyrie', 'Initials': 'K', 'LastName': 'Sellnow', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Weaver', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hahn', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Herringa', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'George Andrew', 'Initials': 'GA', 'LastName': 'James', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Clinton D', 'Initials': 'CD', 'LastName': 'Kilts', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}]",Translational psychiatry,['10.1038/s41398-020-00975-3']
1719,32805363,Effects of Epidural Anesthesia on Quality of Life in Elderly Patients Undergoing Esophagectomy.,"Continuous epidural analgesia during surgery can effectively inhibit surgically induced stress and inflammatory response. It also spares opioid use and reduces postoperative pain. This study explored the effects of intraoperative epidural anesthesia on quality of life and central nervous system injury in elderly patients after esophagectomy. Elderly patients who were scheduled for thoracoscopic-laparoscopic esophagectomy were eligible for this randomized controlled study. The patients in the experimental group received general anesthesia combined with epidural anesthesia, while the patients in the control group received only general anesthesia. At the end of surgery, all patients received the same epidural analgesia program before extubation. Health-related quality of life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaires (QLQ)-C30 and QLQ-OES18 questionnaires. Two HRQoL questionnaires were filled out before surgery, on day 7 and after the third month postoperatively. The Montreal Cognitive Assessment and serum S100β level were also evaluated at baseline and on postoperative day 7. Compared with the group without intraoperative epidural anesthesia, the epidural anesthesia group had better quality of life scores particularly in the social, emotional, and global health domains. The symptoms of nausea, constipation, sleep disorders, dysphagia, reflux, pain, and cough difficulty were less severe. In addition, the S100β content of peripheral blood was also lower on postoperative day 7 (1199.8 pg/mL vs 1341.2 pg/mL, P < 0.001). There was no significant difference in Montreal Cognitive Assessment scores between the 2 groups. Intraoperative epidural anesthesia may improve the quality of life after esophagectomy in elderly patients, and reduce the neuroinflammatory response, compared with the patients receiving general anesthesia only.",2020,"Compared with the group without intraoperative epidural anesthesia, the epidural anesthesia group had better quality of life scores particularly in the social, emotional and global health domains.","['elderly patients undergoing esophagectomy', 'elderly patients', 'Elderly patients who were scheduled for', 'elderly patients after esophagectomy']","['thoracoscopic-laparoscopic esophagectomy', 'Intraoperative epidural anesthesia', 'general anesthesia combined with epidural anesthesia', 'control group received only general anesthesia', 'intraoperative epidural anesthesia', 'epidural anesthesia']","['quality of life', 'MOCA scores', 'Montreal Cognitive Assessment (MOCA) and serum S100β level', 'symptoms of nausea, constipation, sleep disorders, dysphagia, reflux, pain, and cough difficulty', 'postoperative pain', 'quality of life and central nervous system injury', 'Quality of life Quetionnaires (QLQ)-C30 and QLQ-OES18 questionnaires', 'quality of life scores', 'Health-related quality of life (HRQoL', 'European Organisation for Research and Treatment of Cancer (EORTC', 'S100βcontent of peripheral blood']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1264238', 'cui_str': 'Injury of central nervous system'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",,0.0666137,"Compared with the group without intraoperative epidural anesthesia, the epidural anesthesia group had better quality of life scores particularly in the social, emotional and global health domains.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, PR China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, PR China.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, PR China.'}, {'ForeName': 'Gordon Tin Chun', 'Initials': 'GTC', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesiology, The University of Hong Kong, Hong Kong S.A.R, PR China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, PR China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.08.001']
1720,32805434,Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.,"INTRODUCTION


Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
OBJECTIVE


To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs.
METHODS AND ANALYSIS


The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.",2020,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","['152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose', ""cardiorespiratory failure survivors' psychological distress (LIFT2""]","['self-directed mobile mindfulness intervention', 'LIFT intervention', 'telephone-based mindfulness program or education control']","['change in depression symptoms 1\u202fmonth from randomization measured by the PHQ-9 instrument', 'LIFT reduced distress symptoms', 'anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1444565', 'cui_str': 'Cardiorespiratory failure'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",152.0,0.143957,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Medical Center, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Department of Biostatistics & Bioinformatics, Duke Global Health Institute, Duke University, Durham, NC, United States of America. Electronic address: john.gallis@duke.edu.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: laura.porter@duke.edu.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Greeson', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: greeson@rowan.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Gremore', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: tina.gremore@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: amu@uw.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McKeehan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: jeffrey.mckeehan@cuanschutz.edu.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'McDowell', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: brittany.mcdowell@duke.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McDaniel', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: hannah.mcdaniel@cuanschutz.edu.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: marc.moss@cuanschutz.edu.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: houghc@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106119']
1721,32805520,Blunted salivary cortisol response to psychosocial stress in women with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by alterations in the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS). There is evidence for a blunted HPA axis reactivity to psychosocial stress. Less is known about how the SNS reacts to psychosocial stress. Here, we compared the HPA axis and SNS responses to psychosocial stress and a non-stressful condition in patients with PTSD and in healthy individuals. Twenty-one women with PTSD and 32 healthy women participated in the Trier social stress test (TSST) and placebo TSST (P-TSST). We measured salivary cortisol, alpha amylase activity and blood pressure before and after the tests. Subjective perceived stress response was also assessed. We found a blunted cortisol response to the TSST in patients with PTSD compared with healthy participants 10 min (t (51) = -2.58, p = .01) and 25 min (t (51) = -2.16, p = .04) after TSST. We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05). Patients with PTSD, but not healthy participants, reported more dissociative symptoms (t (20) = -2.31, p = .03) and being more tired (t (20) = 2.90, p = .01) directly after TSST compared with the placebo condition. Our results suggest a blunted HPA stress reactivity and an increased subjective perceived stress response in female patients with PTSD. Longitudinal studies could test if these altered stress responses constitute a predisposition to or a cause of PTSD. Future studies should investigate whether these results are transferable to men.",2020,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"['Posttraumatic stress disorder (PTSD', 'patients with PTSD and in healthy individuals', 'women with posttraumatic stress disorder', 'patients with PTSD compared with healthy participants 10\xa0min (t (51)\xa0', 'female patients with PTSD', 'Twenty-one women with PTSD and 32 healthy women participated in the']","['TSST', 'Trier social stress test (TSST) and placebo TSST (P-TSST']","['blunted cortisol response', 'blunted HPA stress reactivity', 'Subjective perceived stress response', 'SNS reactivity', 'dissociative symptoms', 'salivary cortisol, alpha amylase activity and blood pressure', 'Blunted salivary cortisol response']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",21.0,0.0110716,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.014']
1722,32810697,A comparison of young children's spatiotemporal measures of walking and running in three common types of footwear compared to bare feet.,"BACKGROUND


Clinicians and footwear manufacturers often advise young children to wear soft-soled footwear when they are first learning to walk. There is limited evidence as to why this advice is given, and if soft-soled shoes are as close to barefoot as thought.
RESEARCH QUESTION


What are the differences in spatiotemporal measures of gait during walking and running in three common types of children's footwear with a soft-soled compared to barefoot in young children?
METHODS


The study used a quasi-experimental design, with the condition order randomised using a Latin square sequence. Forty-seven children were recruited (2 - 4 years). Participants walked or ran the length of a GAITrite mat in a randomized order for barefoot and soft-soled sneaker, boot and sandal conditions. Linear regression analyses were used to investigate the main effect of each soft-soled footwear compared to bare feet in the different gait parameters.
RESULTS


For walking and running trials, cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition. While wearing sneakers and sandals increased the stance percentage for walking and running trials, compared to barefoot, this difference was only apparent during the running trial for the boots. Likewise, although double support time increased for both the boots and sneakers in walking and running, compared to barefoot, this difference was only observed in the sandals during walking.
SIGNIFICANCE


This research found that various types of soft-soled footwear impacted gait compared to the barefoot condition, with some differences seen between walking and running trials. These findings challenge the assumption that soft-soled footwear facilitate a similar gait to barefoot walking and running, although the clinical significance of these differences is unknown.",2020,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.",['Forty-seven children were recruited (2 - 4\u202fyears'],[],['step time and stride length'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",47.0,0.0330217,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cranage', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia. Electronic address: simone.cranage@monash.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Perraton', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Bowles', 'Affiliation': 'Department of Paramedicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cylie', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.147']
1723,32812876,Comparison of contact surface areas of metatarsal diaphyseal osteotomies for correction of hallux valgus: Experimental study.,"OBJECTIVE


This study aimed to determine, pre-correction, the potential change in the osteotomy-site bony contact surface area that would occur during standard metatarsal diaphyseal procedures with the Baran-Unal modification of Mau osteotomy and then to compare it, post-correction, with the actual osteotomy-site bony contact surface area changes for a standard degree of deformity correction.
METHODS


A total of 30 standard, same sized, biomechanically equivalent, left first metatarsal sawbones were included in this experimental study. They were divided equally into five groups for each of the planned osteotomy techniques: Myerson's modification of Ludloff, Mau, scarf, Offset V, and Baran-Unal modification of Mau osteotomy. The normal osteotomy for each sample was considered as the control, while the corrective osteotomy was the test. Computerized tomography scans and three-dimensional (3D) reconstruction imaging were performed for objective and accurate measurements. The techniques of the osteotomy and post-corrective osteotomy bony contact surface areas were investigated by the two independent research assistants.
RESULTS


There was a statistically significant difference between the contact surface area changes of all pre- and post-corrective osteotomy groups (P<0.05). When the pre- and post-correction contact surface areas of any one group were compared with the other groups, the differences were or were not statistically significant. Mean differences between pre-correction and post-correction areas for Ludloff, Mau, scarf, Offset V, and Baran-Unal osteotomies were 180.7, 122.3, 226.2, 191.9, and 68.9 mm2, and the percentages of area loss were 22.9%, 15.5%, 28.6%, 24.3%, and 8.7%, respectively. The most bony contact area was found in the scarf osteotomy group (mean pre-correction area: 490.5 mm2 and mean post-correction area: 264.3 mm2), but the Baran-Unal modification group has significantly the highest post-correction bony contact area among the all other groups (mean pre-correction area: 413.3 mm2 and mean post-correction area: 344.4 mm2).
CONCLUSION


Metatarsal diaphyseal osteotomies for hallux valgus deformity have the potential not only for deformity correction, but also for contact surface area preservation. This study reaffirms the considerable potential of this new Baran-Unal modification to confer outstanding contact surface area values, even with the operative correction of hallux valgus deformity.",2020,There was a statistically significant difference between the contact surface area changes of all pre- and post-corrective osteotomy groups (P<0.05).,[],"['Metatarsal diaphyseal osteotomies', 'metatarsal diaphyseal osteotomies', ""planned osteotomy techniques: Myerson's modification of Ludloff, Mau, scarf, Offset V, and Baran-Unal modification of Mau osteotomy"", 'Computerized tomography scans and three-dimensional (3D) reconstruction imaging']","['percentages of area loss', 'Ludloff, Mau, scarf, Offset V, and Baran-Unal osteotomies']",[],"[{'cui': 'C0025584', 'cui_str': 'Metatarsal bone structure'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0452258', 'cui_str': 'Scarf'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0452258', 'cui_str': 'Scarf'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]",,0.0176908,There was a statistically significant difference between the contact surface area changes of all pre- and post-corrective osteotomy groups (P<0.05).,"[{'ForeName': 'A Meriç', 'Initials': 'AM', 'LastName': 'Ünal', 'Affiliation': 'Department of Sports Medicine, Süleyman Demirel University, School of Medicine, Isparta, Turkey;Clinic of Orthopaedics and Traumatology, Isparta City Hospital, Isparta, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Budeyri', 'Affiliation': 'Department of Orthopaedics and Traumatology, SANKO University, School of Medicine, Gaziantep, Turkey.'}, {'ForeName': 'Bahattin', 'Initials': 'B', 'LastName': 'Baykal', 'Affiliation': 'Department of Radiology, Süleyman Demirel University, School of Medicine, Isparta, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.17481']
1724,32818720,A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors.,"OBJECTIVE


Interventions for fear of recurrence (FOR) of cancer have nominal effects, perhaps due to limited integration of empirically supported skills. This pilot trial tested the acceptability and feasibility of a multimodal, mind-body resiliency intervention targeting FOR among survivors of various cancers.
METHODS


Early stage cancer survivors 3-30 months post-treatment were recruited to participate in an eight-session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR. Primary outcomes were feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance). Patient-reported outcomes (FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills) were collected at baseline, post-intervention, +1 month, and +3 months. Exit interviews assessed survivors' reported benefits.
RESULTS


Participants (N = 4 groups, 23 survivors, enrollment response rate = 58%) included survivors of seven common cancer types who were on average 12 months post-treatment. Attendance was high (M = 6.1 sessions), and 96% of survivors completed all surveys. Sustained increases in relaxation skills practice 3+ days/week were reported (baseline = 16%, post-intervention = 76%, +3 months = 71%). Most sessions (87%) were rated as highly or very highly acceptable. Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes. Exit interviews revealed behavioral, cognitive, emotional, and existential benefits.
CONCLUSIONS


The targeted mind-body resiliency intervention shows promising acceptability, feasibility, and favorable changes in FOR and coping skills practice. Further adaptation and testing in a randomized trial are warranted. ClinicalTrials.govRegistration Number: NCT03695406.",2020,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","['survivors of various cancers', 'Cancer Survivors', 'Early stage cancer survivors 330\xa0months post-treatment were recruited to participate in an eight']","['multimodal, mind-body resiliency intervention', 'session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR']","['FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills', 'behavioral, cognitive, emotional, and existential benefits', 'feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance', 'FOR severity', 'relaxation skills practice']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.129392,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America. Electronic address: hall@mgh.harvard.edu.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110215']
1725,32818949,Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial.,"BACKGROUND


Intrauterine infection and/or inflammation (Triple I) is an important cause of preterm birth (PTB) and adverse newborn outcomes. N-acetylcysteine (NAC) is a Food and Drug Administration (FDA)-approved drug safely administered to pregnant women with acetaminophen toxicity.
METHODS


We conducted a single-center, quadruple-blind, placebo-controlled trial of pregnant women with impending PTB due to confirmed Triple I. Participants (n = 67) were randomized to an intravenous infusion of NAC or placebo mimicking the FDA-approved regimen. Outcomes included clinical measures and mechanistic biomarkers.
RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34). Fewer NAC-exposed newborns developed two or more prematurity-related severe morbidities [NAC: 21% vs. placebo: 47%, relative risk, 0.45; 95% confidence interval (CI) 0.21-0.95] with the strongest protection afforded against bronchopulmonary dysplasia (BPD, NAC: 3% vs. placebo: 32%, relative risk, 0.10; 95% CI: 0.01-0.73). These effects were independent of gestational age, birth weight, sex, or race. Umbilical cord plasma NAC concentration correlated directly with cysteine, but not with plasma or whole blood glutathione. NAC reduced the placental expression of histone deacetylase-2, suggesting that epigenetic mechanisms may be involved.
CONCLUSIONS


These data provide support for larger studies of intrapartum NAC to reduce prematurity-related morbidity.
IMPACT


In this randomized clinical trial of 65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight. Administration of NAC in amniocentesis-confirmed Triple I resulted in a remarkably lower incidence of BPD. As prior studies have not shown a benefit of postnatal NAC in ventilated infants, our trial highlights the critical antenatal timing of NAC administration. Repurposing of NAC for intrapartum administration should be explored in larger clinical trials as a strategy to improve prematurity-related outcomes and decrease the incidence of BPD.",2020,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","['premature infants with intra-amniotic infection and inflammation (Triple I', '65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight', 'pregnant women with impending PTB due to confirmed Triple I. Participants (n\u2009=\u200967', 'women with idiopathic preterm birth (iPTB, a, b) absent', 'Thirteen patients who were ineligible for the trial based on negative assessment for Triple I contributed placental samples as reference for immunohistochemistry experiments', 'pregnant women with acetaminophen toxicity']","['NAC or placebo', 'Antenatal N-acetylcysteine', 'N-acetylcysteine (NAC', 'placebo (c, d) or N-acetylcysteine infusion (e, f', 'Triple I or PTB', 'NAC', 'immunohistochemical staining for histone deacetylase-2 (HDAC2', 'placebo']","['status at birth and required less intensive resuscitation', 'Umbilical cord plasma NAC concentration', 'BPD', 'clinical measures and mechanistic biomarkers', 'placental expression of histone deacetylase-2', 'prematurity-related severe morbidities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0237963', 'cui_str': 'Poisoning caused by acetaminophen'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0404413', 'cui_str': 'Placental expression'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",65.0,0.55222,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","[{'ForeName': 'Catalin S', 'Initials': 'CS', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA. csb01@uic.edu.'}, {'ForeName': 'Mert Ozan', 'Initials': 'MO', 'LastName': 'Bahtiyar', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Guomao', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abdelghany', 'Affiliation': 'Clinical Department of Pharmacy, Yale New Haven Hospital, New Haven, CT, 06510, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Sonya Abdel', 'Initials': 'SA', 'LastName': 'Razeq', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Antonette T', 'Initials': 'AT', 'LastName': 'Dulay', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Lipkind', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Saya', 'Initials': 'S', 'LastName': 'Mieth', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}]",Pediatric research,['10.1038/s41390-020-01106-w']
1726,32807654,Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508).,"INTRODUCTION


Although chemoradiotherapy (CRT) is the standard of care for patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC), most patients relapse. Tecemotide is a MUC1 antigen-specific cancer immunotherapy vaccine. Bevacizumab improves survival in advanced nonsquamous (NS)-NSCLC and has a role in immune modulation. This phase II trial tested the combination of tecemotide and bevacizumab following CRT in patients with LA-NSCLC.
PATIENTS AND METHODS


Subjects with stage III NS-NSCLC suitable for CRT received carboplatin/paclitaxel weekly + 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel ≤ 4 weeks of completion of CRT (Step 1). Patients with partial response/stable disease after consolidation therapy were registered onto step 2, which was 6 weekly tecemotide injections followed by every 6 weekly injections and bevacizumab every 3 weeks for up to 34 doses. The primary endpoint was to determine the safety of this regimen.
RESULTS


Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity. Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA) were registered to step 2 (tecemotide + bevacizumab). The median number of step 2 cycles received was 11 (range, 2-25). Step 2 worst toxicity included grade 3, N = 9; grade 4, N = 1; and grade 5, N = 1. Grade 5 toxicity in step 2 was esophageal perforation attributed to bevacizumab. Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
CONCLUSIONS


This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC.",2020,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","['Patients with partial response/stable disease after consolidation therapy', 'Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity', 'Cancer (NS-NSCLC', 'Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA', 'patients with LA-NSCLC', 'Subjects with stage III NS-NSCLC suitable for CRT received', 'Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung', 'patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC']","['Immunotherapy With Tecemotide and Bevacizumab', 'Bevacizumab', 'tecemotide and bevacizumab', 'consolidation immunotherapy', 'chemoradiotherapy (CRT', 'carboplatin/paclitaxel weekly\xa0+ 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel', 'bevacizumab']","['Grade 5 toxicity', 'median progression-free survival', 'safety of this regimen', 'survival', 'median progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.311282,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","[{'ForeName': 'Jyoti D', 'Initials': 'JD', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology/Oncology, Northwestern University, Chicago, IL. Electronic address: jd-patel@northwestern.edu.'}, {'ForeName': 'Ju-Whei', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Data Science, Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Carbone', 'Affiliation': 'Department of Medicine, Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Radiation Oncology, Penn State Cancer Institute, Hersey, PA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Maria Teresa P', 'Initials': 'MTP', 'LastName': 'de Aquino', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Sarah Cannon Research Institute, Nashville, TN.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine, UT Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Millie S', 'Initials': 'MS', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care, Palo Alto, CA.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Al-Nsour', 'Affiliation': 'Mercy Cancer Centers, Toledo, OH.'}, {'ForeName': 'Christopher S R', 'Initials': 'CSR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Cancer Institute, Fairfax, VA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.007']
1727,32808345,The effect of 8 weeks of freestyle swim training on the functional fitness of adults with Down syndrome.,"BACKGROUND


Studies conducted on adults with Down syndrome have demonstrated the improvement of functional fitness (aerobic capacity, muscular strength, balance, flexibility, functional ability, body mass or body mass index) with varying exercise modalities but often with one or two components in isolation. Such modalities included walking, running, cycling, rowing or resistance training. Freestyle swim training has shown significant improvements of all parameters associated with functional fitness in the general population. Swimming is an aerobic activity where many of the large muscle groups are involved and may provide more functional fitness benefits. As a consequence, the purpose of our study was to investigate the effect of freestyle swim training on the functional fitness of adults with Down syndrome.
METHODS


Twenty-six adults with Down syndrome (33 ± 6 years; 34 ± 9 kg/m 2  ) were randomly allocated to an exercise (n = 13; 81.3 kg) or control group (n = 13; 81.5 kg). The exercise group performed 8 weeks of freestyle swim training, three times a week, 30 min per session (increased to 40 min after 4 weeks). To evaluate differences between groups, a one-way analysis of variance was used, controlling for differences at baseline.
RESULTS


After 8 weeks of training, the results showed significant differences between the exercise and control group for body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability (P < 0.05). Effect sizes ranged from small to large.
CONCLUSIONS


Various components of functional fitness improved significantly after an intervention period of freestyle swim training. The collective improvement of many functional fitness parameters shown by this study may hold benefits for these often-neglected and in many cases functionally impaired individuals.",2020,"After 8 weeks of training, the results showed significant differences between the exercise and control group for body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability (P < 0.05).","['Twenty-six adults with Down syndrome (33\xa0±\xa06\xa0years; 34\xa0±\xa09\xa0kg/m 2  ', 'adults with Down syndrome']","['Freestyle swim training', 'walking, running, cycling, rowing or resistance training', 'exercise', 'freestyle swim training']","['functional fitness (aerobic capacity, muscular strength, balance, flexibility, functional ability, body mass or body mass index', 'functional fitness', 'body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",26.0,0.0259239,"After 8 weeks of training, the results showed significant differences between the exercise and control group for body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability (P < 0.05).","[{'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Boer', 'Affiliation': 'Department of Human Movement Science, Faculty of Education, Cape Peninsula University of Technology, Wellington, South Africa.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12768']
1728,32808406,An international multicenter efficacy and safety study of IqYmune in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study.,"This prospective, multicenter, single-arm, open-label phase 3 study aimed to evaluate the efficacy and safety of IqYmune in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Patients received one induction dose of 2 g/kg and then seven maintenance doses of 1 g/kg at 3-week intervals. The primary endpoint was the responder rate at the end of study (EOS), defined as an improvement of ≥1 point on the adjusted inflammatory neuropathy cause and treatment (INCAT) disability scale. The responder rate was compared with the responder rate of a historical placebo group (33.3%). Secondary endpoints included changes from baseline to EOS of adjusted INCAT disability score, grip strength, Medical Research Council (MRC) sum score, Rasch-modified MRC sum score, Rasch-built overall disability scale score and the clinical global impression. Forty-two patients, including 23 Ig-naïve and 19 Ig-pre-treated, were included in the efficacy set. The overall response rate at EOS was 76.2% (95% confidence interval [60.5%-87.9%]). The superiority of IqYmune compared to the historical placebo control was demonstrated (P < .0001). The responder rate was numerically higher in Ig-pre-treated than in Ig-naïve patients but confidence intervals were overlapping (84.2% [60.4%-96.6%] vs 69.6% [47.1%-86.8%]). All secondary endpoints confirmed this conclusion. The median time to response was 15 weeks [8.9-19.1 weeks]. A total of 156 adverse events including five serious were considered related to IqYmune, 87.2% were mild. Neither hemolysis nor signs of renal or hepatic impairment were observed. These results demonstrate that IqYmune is an effective and well-tolerated treatment in patients with CIDP.",2020,The superiority of IqYmune® compared to the historical placebo control was demonstrated (p<0.0001).,"['patients with CIDP', 'patients with chronic inflammatory demyelinating polyradiculoneuropathy', 'patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP']","['historical placebo', '®', 'IqYmune®']","['overall response rate at EOS', 'responder rate', 'changes from baseline to EOS of adjusted INCAT disability score, grip strength, Medical Research Council (MRC) sum score, Rasch-modified MRC sum score, Rasch-built overall disability scale score and the clinical global impression', 'efficacy and safety', 'hemolysis nor signs of renal or hepatic impairment', 'median time to response', 'responder rate at the end of study (EOS), defined as an improvement of ≥1 point on the adjusted inflammatory neuropathy cause and treatment (INCAT) disability scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0270933', 'cui_str': 'Inflammatory neuropathy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",,0.16641,The superiority of IqYmune® compared to the historical placebo control was demonstrated (p<0.0001).,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Nobile-Orazio', 'Affiliation': 'Neuromuscular and Neuroimmunology Service, IRCCS Humanitas Clinical and Research Center, Milan University, Via Manzoni 56, Rozzano, Milan, 20089, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pujol', 'Affiliation': 'LFB, Les Ulis, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kasiborski', 'Affiliation': 'LFB, Les Ulis, France.'}, {'ForeName': 'Rabye', 'Initials': 'R', 'LastName': 'Ouaja', 'Affiliation': 'LFB, Les Ulis, France.'}, {'ForeName': 'Gilles Della', 'Initials': 'GD', 'LastName': 'Corte', 'Affiliation': 'Dellmed Consulting, Ornex, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bonek', 'Affiliation': 'Department of Neurology, NeuroCenter, Regional Specialist Hospital, Bydgoszcz, Poland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Istituti Clinici Scientifici Maugeri, Turin, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Schenone', 'Affiliation': 'Department of Neurosciences, Rehabilitation, Ophthalmology, Genetic and Maternal and Infantile Sciences (DINOGMI), University of Genova and IRCCS Policlinico San Martino, Genova, Italy.'}]",Journal of the peripheral nervous system : JPNS,['10.1111/jns.12408']
1729,32809136,Conservative oxygen therapy for mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy.,"PURPOSE


Liberal use of oxygen may contribute to secondary brain injury in patients with hypoxic-ischaemic encephalopathy (HIE). However, there are limited data on the effect of different oxygen regimens on survival and neurological disability in HIE patients.
METHODS


We undertook a post-hoc analysis of the 166 patients with suspected HIE enrolled in a trial comparing conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary endpoint for the current analysis was death or unfavourable neurological outcome at day 180. Key secondary outcomes were day 180 mortality, and cause-specific mortality.
RESULTS


Patients with HIE allocated to conservative oxygen spent less time in the ICU with an SpO 2  ≥ 97% (26 h [interquartile range (IQR) 13-45 vs. 35 h [IQR 19-70], absolute difference, 9 h; 95% CI - 21.4 to 3.4). A total of 43 of 78 patients (55.1%) assigned to conservative oxygen and 49 of 72 patients (68.1%) assigned to usual oxygen died or had an unfavourable neurological outcome at day 180; odds ratio 0.58; 95% CI 0.3-1.12; P = 0.1 adjusted odds ratio 0.54; 95% CI 0.23-1.26; P = 0.15. A total of 37 of 86 patients (43%) assigned to conservative oxygen and 46 of 78 (59%) assigned to usual oxygen had died by day 180; odds ratio 0.53; 95% CI 0.28-0.98; P = 0.04; adjusted odds ratio 0.56; 95% CI 0.25-1.23; P = 0.15. Cause-specific mortality was similar by treatment group.
CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180. The potential for important benefit or harm from conservative oxygen therapy in HIE patients is not excluded by these data.",2020,"CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","['mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy', '1000 mechanically ventilated ICU patients', '166 patients with suspected HIE enrolled in a trial comparing', 'Patients with HIE', 'HIE patients', 'patients with hypoxic-ischaemic encephalopathy (HIE']","['conservative oxygen therapy with usual oxygen therapy', 'Conservative oxygen therapy']","['day 180 mortality, and cause-specific mortality', 'survival and neurological disability', 'death or unfavourable neurological outcomes', 'Cause-specific mortality', 'death or unfavourable neurological outcome']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1000.0,0.358589,"CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06196-y']
1730,32810363,The potential benefit of continuous metered-dose inhaler inhalation technique verbal counselling on asthmatic.,"BACKGROUND


Subjects' improper usage of their metered-dose inhalers (MDI) is considered a chief cause of poor asthma control. The work presented here aims to evaluate the effect of MDI verbal counselling on subjects' lung function and inhalation technique.
METHOD


A total number of 900 asthmatic subjects (450 female) were gathered from University hospital outpatient clinics from January 2017 to May 2019 with a mean (SD) age 45.2 (17.1) years old. They were divided into two groups. The first was monthly asthma follow-up, for three visits, (450 (266 females) subjects). The other group was monthly asthma follow-up, for three visits plus MDI inhalation technique verbal counselling (450 (184 female) subjects). At the beginning of studying group 2 and at every monthly visit (three visits), each subject was asked to show the investigator his MDI inhalation technique and the number of mistakes was noticed and adjusted. Additionally, at each visit, their forced expiratory volume in one second (FEV 1  ) as a percentage of the forced vital capacity (FVC) and peak expiratory flow (PEF) were measured.
RESULTS


No subject dropped out from group 2; however, 95 subjects dropped out from group 1 with no improvement in the lung function tests. The mean number of accurate steps of the MDI inhalation technique observed in group 2 was improved significantly (P < .001) as the number of visits increased particularly in children. ""Start to inhale slowly, through the mouth and at the same time press the canister to actuate a dose and maintain a slow and deep inhalation, through the mouth, until the lungs are full of air (This should take an adult 4-5 seconds)"" was the common repetitive mistake. There was a significant improvement (P < .05) in the lung function test scores after the counselling in group 2, especially in old subjects.
CONCLUSIONS


MDI's counselling must be continually offered to the asthmatic subject at any possible chance to improve and sustain the optimal MDI inhalation technique and probably improve subjects' lung function score.",2020,"There was a significant improvement (p<0.05) in the lung function test scores after the counselling in group 2, especially in old subjects.
","['450 (184 female) subjects', ""subjects' lung function and inhalation technique"", 'asthmatic', 'A total number of 900 asthmatic subjects (450 female) were gathered from University hospital outpatient clinics from January 2017 to May 2019 with a mean(SD) age 45.2(17.1) years old']","['MDI inhalation technique verbal counselling', 'MDI verbal counselling']","['forced vital capacity (FVC) and peak expiratory flow (PEF', 'mean number of accurate steps of the MDI inhalation technique', 'lung function tests', 'lung function test scores', 'number of visits']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0665509', 'cui_str': 'OF 900'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",900.0,0.0115041,"There was a significant improvement (p<0.05) in the lung function test scores after the counselling in group 2, especially in old subjects.
","[{'ForeName': 'Xingai', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Respiratory Medicine Department, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Dongqin', 'Initials': 'D', 'LastName': 'Sheng', 'Affiliation': 'Respiratory Medicine Department, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Xiangqiao', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Extracardiac ICU, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Neurology Department, Qilu Hospital of Shandong University, Jinan, Shandong Province, China.'}]",International journal of clinical practice,['10.1111/ijcp.13682']
1731,32811637,Treating cannabis use disorder: Exploring a treatment as needed model with 34-month follow-up.,"Research has demonstrated that motivational enhancement (MET) and cognitive behavioral therapy (CBT) are some of the most effective interventions for adults with cannabis use disorder (CUD). As few as two sessions of combined MET and CBT has produced abstinence and reductions in cannabis use greater than delayed treatment controls. Despite their efficacy, outcomes in previous studies yielded abstinence rates from cannabis in the range of 20-30% at follow-ups of 6 to 12 months, and CUD remained a chronic condition for many. Additional models of providing treatment ""as needed"" (PRN), rather than as a single fixed-dose, are necessary to meet the different needs of adults with CUD and reengage those who do not respond to treatment initially or who relapse later. In the current study, 87 adults who met DSM-IV criteria for cannabis dependence were randomly assigned to receive either a fixed-dose of nine sessions of MET/CBT or to a PRN condition that provided a smaller initial dose of treatment, but allowed repeated access to treatment for 28 months. Cannabis use and associated problems were assessed every six months throughout a 34-month period. More than one-third of participants in the PRN condition accessed additional treatment episodes, but the total number of treatment sessions that participants utilized was comparable across conditions. Both treatments yielded significant reductions in cannabis use and associated problems at each follow-up. Contrary to hypotheses, the PRN condition did not yield better outcomes at the longer-term follow-ups. The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes. Future studies should test active approaches to reengaging participants with treatment when initial outcomes are less than optimal.",2020,"The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes.","['87 adults who met DSM-IV criteria for cannabis dependence', 'adults with CUD and reengage those who do not respond to treatment initially or who relapse later', 'adults with cannabis use disorder (CUD', 'Treating cannabis use disorder']","['CBT', 'cognitive behavioral therapy (CBT']","['rates of abstinence', 'abstinence rates', 'cannabis use and associated problems', 'total number of treatment sessions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",87.0,0.061929,"The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes.","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: stephens@vt.edu.'}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: robrina.walker@utsouthwestern.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'DeMarce', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: jdemarce@vt.edu.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Lozano', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: brian.lozano@va.gov.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Rowland', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: jared.rowland@va.gov.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, 909 NE 43rd St. Suite 304, Seattle, WA 98105, United States of America. Electronic address: ddwalker@u.washington.edu.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Roffman', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, 909 NE 43rd St. Suite 304, Seattle, WA 98105, United States of America. Electronic address: roffman@uw.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108088']
1732,32812363,Transcutaneous spinal direct current stimulation increases corticospinal transmission and enhances voluntary motor output in humans.,"Optimization of motor performance is of importance in daily life, in relation to recovery following injury as well as for elite sports performance. The present study investigated whether transcutaneous spinal direct current stimulation (tsDCS) may enhance voluntary ballistic activation of ankle muscles and descending activation of spinal motor neurons in able-bodied adults. Forty-one adults (21 men; 24.0 ± 3.2 years) participated in the study. The effect of tsDCS on ballistic motor performance and plantar flexor muscle activation was assessed in a double-blinded sham-controlled cross-over experiment. In separate experiments, the underlying changes in excitability of corticospinal and spinal pathways were probed by evaluating soleus (SOL) motor evoked potentials (MEPs) following single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex, SOL H-reflexes elicited by tibial nerve stimulation and TMS-conditioning of SOL H-reflexes. Measures were obtained before and after cathodal tsDCS over the thoracic spine (T11-T12) for 10 min at 2.5 mA. We found that cathodal tsDCS transiently facilitated peak acceleration in the ballistic motor task compared to sham tsDCS. Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes. The short-latency facilitation of the H-reflex by subthreshold TMS, which is assumed to be mediated by the fast conducting monosynaptic corticomotoneuronal pathway, was also enhanced by tsDCS. We argue that tsDCS briefly facilitates voluntary motor output by increasing descending drive from corticospinal neurones to spinal plantar flexor motor neurons. tsDCS can thus transiently promote within-session CNS function and voluntary motor output and holds potential as a technique in the rehabilitation of motor function following central nervous lesions.",2020,"Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes.","['Forty-one adults (21 men; 24.0\xa0±\xa03.2\xa0years) participated in the study', 'able-bodied adults', 'humans']","['transcutaneous spinal direct current stimulation (tsDCS', 'tsDCS', 'single-pulse transcranial magnetic stimulation (TMS', 'Transcutaneous spinal direct current stimulation']","['H-reflex amplitudes', 'ballistic motor performance and plantar flexor muscle activation', 'soleus (SOL) motor evoked potentials (MEPs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}]",41.0,0.088158,"Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes.","[{'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Mikkel M', 'Initials': 'MM', 'LastName': 'Beck', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Therkildsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Svane', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Forman', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lorentzen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Bernard A', 'Initials': 'BA', 'LastName': 'Conway', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Lundbye-Jensen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Svend S', 'Initials': 'SS', 'LastName': 'Geertsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Jens B', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}]",Physiological reports,['10.14814/phy2.14531']
1733,32812384,Muscular endurance and muscle metabolic responses to 8 weeks of omega-3 polyunsaturated fatty acids supplementation.,"BACKGROUND


It has been well known that exercise training improves muscular endurance; however, whether nutritional strategies can be used to enhance muscular endurance remains unclear. Herein, we tested the hypothesis that 8 weeks of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation, known to promote oxygen availability and lipid metabolism, would attenuate muscular fatigue caused by numerous muscle contractions.
METHODS


Nineteen healthy men were randomly assigned to a placebo group (n = 9) and fish oil group (n = 10) in a double-blind fashion. The fish oil group consumed EPA-rich fish oil that contains 600-mg EPA and 260-mg DHA per day for 8 weeks. The placebo group received matching capsules for the same duration of time. After the 8-week intervention, subjects performed muscular endurance test that was repeated knee extensions with weights equal to 40% of the subject's body weight.
RESULTS


Maximal repetitions to exhaustion were recorded. In addition, maximum isometric voluntary muscle contraction (MVC), muscle metabolism using near-infrared spectroscopy, and blood lactate were measured during the test. Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups. Similarly, there is no significant difference in oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability, between the groups. Also, MVC and blood lactate did not change between groups.
CONCLUSION


In conclusion, the present study provided evidence that muscle fatigue caused by knee extensions cannot be attenuated by EPA and DHA supplementation in healthy subjects.",2020,"Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups.","['Nineteen healthy men', 'healthy subjects']","['exercise training', 'omega-3 polyunsaturated fatty acids supplementation', 'placebo group (n\xa0=\xa09) and fish oil group', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation', 'placebo']","['maximum isometric voluntary muscle contraction (MVC), muscle metabolism using near-infrared spectroscopy, and blood lactate', 'MVC and blood lactate', 'muscular endurance', 'Muscular endurance and muscle metabolic responses', 'oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",19.0,0.209075,"Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Morishima', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Laboratory of Health and Sports Sciences, Meiji Gakuin University, Kanagawa, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'Faculty of Health and Medical Science, Teikyo Heisei University, Chiba, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, Japan.'}]",Physiological reports,['10.14814/phy2.14546']
1734,32813051,The emotional impact of the COVID-19 pandemic on individuals with progressive multiple sclerosis.,"OBJECTIVE


Individuals with pre-existing chronic illness have shown increased anxiety and depression due to COVID-19. Here, we examine the impact of the COVID-19 pandemic on emotional symptomatology and quality of life in individuals with Progressive Multiple Sclerosis (PMS).
METHODS


Data were obtained during a randomized clinical trial on rehabilitation taking place at 11 centers in North America and Europe. Participants included 131 individuals with PMS. Study procedures were interrupted in accordance with governmental restrictions as COVID-19 spread. During study closure, a COVID Impact Survey was administered via telephone or email to all participants, along with measures of depressive symptoms, anxiety symptoms, quality of life, and MS symptomatology that were previously administered pre-pandemic.
RESULTS


4% of respondents reported COVID-19 infection. No significant changes were noted in anxiety, quality of life, or the impact of MS symptomatology on daily life from baseline to lockdown. While total HADS-depression scores increased significantly at follow-up, this did not translate into more participants scoring above the HADS threshold for clinically significant depression. No significant relationships were noted between disease duration, processing speed ability or EDSS, and changes in symptoms of depression or anxiety. Most participants reported the impact of the virus on their psychological well-being, with a little impact on financial well-being. The perceived impact of the pandemic on physical and psychological well-being was correlated with the impact of MS symptomatology on daily life, as well as changes in depression.
CONCLUSIONS


Overall, little change was noted in symptoms of depression or anxiety or overall quality of life.",2020,"No significant changes were noted in anxiety, quality of life, or the impact of MS symptomatology on daily life from baseline to lockdown.","['Individuals with pre-existing chronic illness', 'Participants included 131 individuals with PMS', 'individuals with progressive multiple sclerosis', 'at 11 centers in North America and Europe', 'individuals with Progressive Multiple Sclerosis (PMS']","['COVID-19 pandemic', 'rehabilitation taking place']","['symptoms of depression or anxiety or overall quality of life', 'COVID-19 infection', 'disease duration, processing speed ability or EDSS, and changes in symptoms of depression or anxiety', 'emotional symptomatology and quality of life', 'total HADS-depression scores', 'anxiety, quality of life, or the impact of MS symptomatology on daily life', 'depressive symptoms, anxiety symptoms, quality of life, and MS symptomatology']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",131.0,0.19236,"No significant changes were noted in anxiety, quality of life, or the impact of MS symptomatology on daily life from baseline to lockdown.","[{'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA. nchiaravalloti@kesslerfoundation.org.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, University College London, London, WC1B 5EH, UK.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Moore', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Division of Neuroscience, Neuroimaging Research Unit, Institute of Experimental Neurology, IRCSS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Devon, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Division of Neuroscience, Neuroimaging Research Unit, Institute of Experimental Neurology, IRCSS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama At Birmingham, Birmingham, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-10160-7']
1735,32815436,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo.,"Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA), recently approved in the USA and other countries. This paper reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had statistically significant reductions in glycated hemoglobin (HbA 1   c ) of 0.9%, 1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator studies, oral semaglutide 14 mg provided better glycemic control than empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight reductions were significantly greater with oral semaglutide than with placebo and sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus empagliflozin 25 mg were not significantly different. Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time. Across these trials, 5-13% and 15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic hypoglycemia occurred infrequently with oral semaglutide and was seen most often in patients taking concomitant sulfonylureas. Findings from these trials indicate that the addition of oral semaglutide reduces HbA 1   c  and body weight and is associated with a low risk of hypoglycemia. Oral semaglutide represents an additional option for treating people with type 2 diabetes in primary care, with the potential to expand the numbers of patients benefiting from GLP-1RAs beyond that currently seen with injectable formulations.",2020,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.",['patients with type 2 diabetes'],"['Oral semaglutide', 'oral semaglutide monotherapy', 'empagliflozin', 'oral antihyperglycemic agents and placebo', 'placebo, empagliflozin 25 mg, or sitagliptin 100 mg', 'oral semaglutide', 'placebo']","['HbA 1c  and body weight', 'Body weight reductions', 'glycated hemoglobin (HbA 1c ', 'Severe or blood glucose-confirmed symptomatic hypoglycemia', 'body weight reductions', 'nausea', 'Gastrointestinal adverse events (AEs) with oral semaglutide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",,0.127093,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lavernia', 'Affiliation': 'North Broward Diabetes Center , Pompano Beach, FL, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Department of Endocrinology, Ochsner Medical Center , New Orleans, LA, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1798638']
1736,32815438,The efficacy of the figure-of-eight suture technique in the treatment of tunnel bleeding of the femoral artery route after percutaneous coronary intervention or angiography.,"OBJECTIVE


To evaluate the efficacy of the figure-of-eight (FOE) suture technique in the treatment of tunnel bleeding after femoral artery puncture compared with manual compression (MC).
METHODS


This prospective, randomized, controlled study enrolled patients that had received transfemoral coronary artery angiography or percutaneous coronary intervention and then developed tunnel bleeding. They were randomly assigned into two groups: FOE suture group (ES group) and manual compression group (MC group). Total treatment time, performance frequency, performance time, rate of deep vein thrombosis (DVT) and in-hospital time after the procedure were compared.
RESULTS


A total of 152 patients were enrolled in the study (ES group,  n  = 63; MC group,  n  = 89). Compared with the MC group, the total treatment time (mean ± SD: ES 22.3 ± 5.4 h versus MC 26.8 ± 6.8 h), performance frequency (mean ± SD: ES 2.1 ± 0.7 versus MC 2.6 ± 1.1), performance time (mean ± SD: ES 8.9 ± 2.5 min versus MC 12.3 ± 4.1 min), in-hospital time after the procedure (mean ± SD: ES 3.5 ± 1.2 days versus MC 4.8 ± 2.1 days) and DVT rate (ES 0.0% versus MC 6.7%) were significantly lower in the ES group.
CONCLUSION


The FOE suture technique effectively treated tunnel bleeding after femoral artery puncture.",2020,"Compared with the MC group, the total treatment time (mean ± SD: ES 22.3 ± 5.4 h versus MC 26.8 ± 6.8 h), performance frequency (mean ± SD: ES 2.1 ± 0.7 versus MC 2.6 ± 1.1), performance time (mean ± SD: ES 8.9 ± 2.5 min versus MC 12.3 ± 4.1 min), in-hospital time after the procedure (mean ± SD: ES 3.5 ± 1.2 days versus MC 4.8 ± 2.1 days) and DVT rate (ES 0.0% versus MC 6.7%) were significantly lower in the ES group.
","['tunnel bleeding after femoral artery puncture', 'A total of 152 patients were enrolled in the study (ES group,  n \u2009=\u200963; MC group,  n \u2009=\u200989', 'enrolled patients that had received transfemoral coronary artery angiography or percutaneous coronary intervention and then developed tunnel bleeding', 'tunnel bleeding of the femoral artery route after percutaneous coronary intervention or angiography']","['FOE suture group (ES group) and manual compression group (MC group', 'manual compression (MC', 'figure-of-eight (FOE) suture technique', 'figure-of-eight suture technique']","['Total treatment time, performance frequency, performance time, rate of deep vein thrombosis (DVT) and in-hospital time', 'tunnel bleeding', 'hospital time', 'performance time', 'DVT rate', 'total treatment time']","[{'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",152.0,0.0311078,"Compared with the MC group, the total treatment time (mean ± SD: ES 22.3 ± 5.4 h versus MC 26.8 ± 6.8 h), performance frequency (mean ± SD: ES 2.1 ± 0.7 versus MC 2.6 ± 1.1), performance time (mean ± SD: ES 8.9 ± 2.5 min versus MC 12.3 ± 4.1 min), in-hospital time after the procedure (mean ± SD: ES 3.5 ± 1.2 days versus MC 4.8 ± 2.1 days) and DVT rate (ES 0.0% versus MC 6.7%) were significantly lower in the ES group.
","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jing-Guo', 'Initials': 'JG', 'LastName': 'Nong', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Quan-Zhou', 'Initials': 'QZ', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Cai-Yi', 'Initials': 'CY', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520947307']
1737,32815439,"Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients.","Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years. There are many therapies for the treatment of T2D but not all are suitable for patients with comorbidities. Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA) and was recently approved for the treatment of T2D, representing an oral alternative to injectable GLP-1RAs. This article reviews data from: PIONEER 6, a phase 3a cardiovascular outcomes trial in patients at high cardiovascular risk; PIONEER 5, a phase 3a trial in patients with moderate renal impairment; a post-hoc analysis of PIONEER data by age; and pharmacokinetic trials investigating the effects of renal impairment, gastrointestinal disease, and hepatic impairment on the exposure of oral semaglutide. PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide compared with placebo (hazard ratio: 0.79; 95% confidence interval [CI]: 0.57, 1.11; p < 0.001 for noninferiority), ruling out excess cardiovascular risk. In PIONEER 5, oral semaglutide was superior to placebo in decreasing glycated hemoglobin over 26 weeks (estimated treatment difference [ETD]: -0.8%; 95% CI: -1.0, -0.6; p < 0.0001) and body weight (ETD: -2.5 kg; 95% CI: -3.2, -1.8; p < 0.0001), and renal function was unchanged in both treatment groups. There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide. Across the trials, the safety profile of oral semaglutide was as expected for a GLP-1RA, with gastrointestinal adverse events most commonly reported. As such, oral semaglutide provides an effective oral GLP-1RA treatment option in older patients and/or those with comorbidities, with no requirements for dose adjustment.",2020,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"['older patients and/or those with comorbidities', 'patients with comorbidities', 'patients at high cardiovascular risk', 'Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years', 'patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients', 'patients with moderate renal impairment']","['Oral semaglutide', 'ETD', 'placebo']","['renal function', 'body weight', 'glycated hemoglobin', 'cardiovascular safety of oral semaglutide', 'safety profile of oral semaglutide', 'glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}]",,0.0838752,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem , Jerusalem, Israel.'}, {'ForeName': 'Eden M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation , Bend, OR, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Physicians East , Greenville, NC, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1800286']
1738,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: vaishali.thakare@dypatil.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'NAMO Medical Education and Research Institute, Silvassa, DNH&DD, India. Electronic address: rksubodh@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India. Electronic address: sunildrkelgane@gmail.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
1739,32819412,Virtual reality-based action observation facilitates the acquisition of body-powered prosthetic control skills.,"BACKGROUND


Regular body-powered (BP) prosthesis training facilitates the acquisition of skills through repeated practice but requires adequate time and motivation. Therefore, auxiliary tools such as indirect training may improve the training experience and speed of skill acquisition. In this study, we examined the effects of action observation (AO) using virtual reality (VR) as an auxiliary tool. We used two modalities during AO: three-dimensional (3D) VR and two-dimensional (2D) computer tablet devices (Tablet). Each modality was tested from first- and third-person perspectives.
METHODS


We studied 40 healthy right-handed participants wearing a BP prosthesis simulator on their non-dominant hands. The participants were divided into five groups based on combinations of the different modalities and perspectives: first-person perspective on VR (VR1), third-person perspective on VR (VR3), first-person perspective on a tablet (Tablet1), third-person perspective on a tablet (Tablet3), and a control group (Control). The intervention groups observed and imitated the video image of prosthesis operation for 10 min in each of two sessions. We evaluated the level of immersion during AO using the visual analogue scale. Prosthetic control skills were evaluated using the Box and Block Test (BBT) and a bowknot task (BKT).
RESULTS


In the BBT, there were no significant differences in the amount of change in the skills between the five groups. In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group. Additionally, the immersion scores of VR1 (p < 0.05, d = 1.45) and VR3 (p < 0.05, d = 1.18) were higher than those of Tablet3. There was a significant negative correlation between the immersion scores and the relative change in the BKT scores (Spearman's r s  = - 0.47, p < 0.01).
CONCLUSIONS


Using the BKT of bilateral manual dexterity, VR-based AO significantly improved short-term prosthetic control acquisition. Additionally, it appeared that the higher the immersion score was, the shorter the execution time of the BKT task. Our findings suggest that VR-based AO training may be effective in acquiring bilateral BP prosthetic control, which requires more 3D-based operation.",2020,"In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group.",['40 healthy right-handed participants wearing a BP prosthesis simulator on their non-dominant hands'],"['person perspective on VR (VR1), third-person perspective on VR (VR3), first-person perspective on a tablet (Tablet1), third-person perspective on a tablet (Tablet3), and a control group (Control', 'Regular body-powered (BP) prosthesis training', 'AO: three-dimensional (3D) VR and two-dimensional (2D) computer tablet devices (Tablet', 'Virtual reality-based action observation', 'VR-based AO training', 'action observation (AO) using virtual reality (VR']","['Box and Block Test (BBT) and a bowknot task (BKT', 'execution time of the BKT task', 'immersion scores of VR1', 'VR3', 'BKT scores']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0170855,"In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group.","[{'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan. mnb328@med.kawasaki-m.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kurumadani', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Osaka', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Katsutoshi', 'Initials': 'K', 'LastName': 'Senoo', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Date', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ueda', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Kawasaki Medical School Hospital, Okayama, Japan, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Hanayama', 'Affiliation': 'Kawasaki Medical School, Department of Rehabilitation Medicine, Okayama, Japan, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sunagawa', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00743-w']
1740,32836103,Self-reported health status and the associated risk of mortality in heart failure: The DANISH trial.,"OBJECTIVE


To examine the gradual association between self-reported health status and mortality in patients with heart failure (HF) as current research has focused on poor health status and increased risk of mortality.
METHOD


This is a substudy of the DANISH (Defibrillator Implantation in Patients with Nonischemic Systolic HF) trial in which 1116 patients were randomized to receive or not receive an implantable cardioverter-defibrillator. Health status was assessed by a single question of the Short-Form 36. Patients were classified as having excellent/very good, good, fair (reference) or poor health status. We assessed the association between health status and mortality using multivariable Cox proportional hazard models.
RESULTS


Self-reported health status was completed by 943 (84%) patients at randomization with a median follow-up of 67 months and a health status distribution of; excellent/very good (n = 79, 8%), good (n = 369, 39%), fair (n = 409, 43%), and poor (n = 86, 9%). All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57). The gradual difference yielded a crude hazard ratio (HR) of 0.40, 95% CI 0.20-0.80 (adjusted HR 0.47 (95% CI 0.23-0.95) for excellent/ very good health status, HR 0.71, 95% CI 0.52-0.97 (adjusted HR 0.78 (95% CI 0.56-1.08) for good health status. Poor being worse than fair health status yielded a crude HR of 1.07, 95% CI 0.67-1.69.
CONCLUSION


Excellent/very good self-reported health status as assessed by a single question was associated with lower long-term mortality in patients with HF.",2020,"All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57).","['patients with heart failure (HF', 'patients with HF', 'heart failure', 'Patients with Nonischemic Systolic HF) trial in which 1116 patients', 'Patients were classified as having excellent/very good, good, fair (reference) or poor health status']","['implantable cardioverter-defibrillator', 'DANISH (Defibrillator Implantation']","['Self-reported health status', 'Health status', 'crude hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2911689', 'cui_str': 'Fair'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",1116.0,0.0161855,"All-cause mortality (death events/ 100 person-years) occurred with gradual differences according to health status from excellent/ very good (2.14), good (3.74), fair (5.21) to poor health status (5.57).","[{'ForeName': 'Johan S', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: johan.skov.bundgaard.01@regionh.dk.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology and Clinical Research, Nordsjaellands Hospital, Hillerød, Denmark; Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Rørth', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Melchior', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.; Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110220']
1741,32836109,Sleep problems associated with long-term mortality in acute coronary syndrome: Effects of depression comorbidity and treatment.,"OBJECTIVES


The effects of sleep disturbance and its treatment on the prognosis of patients with acute coronary syndrome (ACS) are not well understood. This study investigated the impact of sleep disturbance on long-term all-cause mortality, according to depression comorbidity and treatment, in patients with ACS.
METHODS


A cross-sectional baseline study and a nested 24-week double-blind escitalopram-placebo controlled trial were carried out from May 2007 to March 2013; 5-12-year follow-up for all-cause mortality was conducted. A total of 1152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (N = 706), depression on escitalopram (N = 149), depression on placebo (N = 151), and depression on medical care as usual (CAU; N = 146). Sleep disturbance was evaluated by the Leeds Sleep Evaluation Questionnaire. During the 5-12-year follow-up, Kaplan-Meyer event rates for all-cause mortality were calculated; hazard ratios (HRs) using Cox regression models were estimated after adjustment for a range of covariates.
RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59). The associations between worse sleep states and long-term all-cause mortality were significant in patients without depression and in patients with depression who received CAU, but not in patients with depression who participated in the 24-week trial.
CONCLUSIONS


Routine evaluations of sleep disturbance in ACS and further treatment allocation may contribute to reducing long-term mortality associated with the disease.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier for the 24 week drug trial, NCT00419471.",2020,"RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59).","['May 2007 to March 2013; 5-12-year follow-up for all-cause mortality was conducted', 'acute coronary syndrome', '1152 patients with ACS were stratified by baseline depression comorbidity and treatment allocation into four groups: no depression (N\xa0=\xa0706), depression on escitalopram (N\xa0=\xa0149), depression on placebo (N\xa0=\xa0151), and depression on medical care as usual (CAU; N\xa0=\xa0146', 'patients with acute coronary syndrome (ACS', 'patients with ACS']","['CAU', 'escitalopram-placebo']","['Sleep disturbance', 'Leeds Sleep Evaluation Questionnaire']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",1152.0,0.0763454,"RESULTS


Worse sleep states at baseline increased long-term all-cause mortality in all patients (HRs 1.08-1.59).","[{'ForeName': 'Ju-Wan', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': ""King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK; South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Hee-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Hee-Ju', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung-Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Il-Seon', 'Initials': 'IS', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Min-Chul', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Joon', 'Initials': 'YJ', 'LastName': 'Hong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Young-Keun', 'Initials': 'YK', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Myung-Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jin-Sang', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Jae-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea. Electronic address: jmkim@chonnam.ac.kr.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.08.004']
1742,32836188,Comparison of low and high inspiratory oxygen fraction added to lung-protective ventilation on postoperative pulmonary complications after abdominal surgery: A randomized controlled trial.,"STUDY OBJECTIVE


Intraoperative lung-protective ventilation strategy has been recommended to reduce postoperative pulmonary complications (PPCs). However, the role of inspiratory oxygen fraction (FiO 2 ) in this protection remains highly uncertain. We aimed to evaluate the effect of intraoperative low (30%) versus high (80%) FiO 2  in the context of lung-protective ventilation strategy on PPCs in patients undergoing abdominal surgery.
DESIGN


Prospective, two-arm, randomized controlled trial.
SETTING


Tertiary university hospital in China.
PATIENTS


A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study.
INTERVENTION


Patients were randomly assigned to receive either 30% or 80% FiO 2  during the intraoperative period. All patients received volume-controlled mechanical ventilation with lung-protective ventilation approach, which included a tidal volume of 8 ml kg -1  of predicted body weight, a positive end-expiratory pressure level of 6-8 cmH 2 O, and repeated recruitment maneuvers.
MEASUREMENTS


The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis. The severity grade of PPCs was measured as a key secondary outcome.
MAIN RESULTS


Two hundred and fifty-one patients completed the trial. PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025). The severity of PPCs within the first 7 days following surgery was attenuated significantly in the low (30%) FiO 2  group (p = 0.001).
CONCLUSIONS


Among patients undergoing abdominal surgery under general anesthesia, an intraoperative lung-protective ventilation strategy with 30% FiO 2  compared with 80% FiO 2  did not reduce the incidence of PPCs. And the use of 30% FiO 2  resulted in less severe pulmonary complications.",2020,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","['patients undergoing abdominal surgery', 'patients undergoing abdominal surgery under general anesthesia', 'Tertiary university hospital in China', 'Two hundred and fifty-one patients completed the trial', 'A total of ASA I-III 252 patients aged ≥18, who were scheduled for elective abdominal surgery under general anesthesia were included in the study', 'postoperative pulmonary complications after abdominal surgery']","['volume-controlled mechanical ventilation with lung-protective ventilation approach', 'low and high inspiratory oxygen fraction added to lung-protective ventilation']","['severe pulmonary complications', 'composite of postoperative pulmonary complications within the first 7 postoperative days, consisting of respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, and aspiration pneumonitis', 'PPCs', 'severity of PPCs', 'severity grade of PPCs', 'incidence of PPCs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449972', 'cui_str': 'Volume control'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0006266', 'cui_str': 'Bronchospasm'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.482006,"PPCs occurred in 43 of 125 (34.4%) patients assigned to receive 30% FiO 2  compared with 59 of 126 (46.8%) patients receiving 80% FiO 2  (relative risk 0.74, 97.5% confidence interval, 0.51-1.02, p = 0.045, > 0.025).","[{'ForeName': 'Xue-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Yu-Lian', 'Initials': 'YL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Meng-Qiu', 'Initials': 'MQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Lei-Lei', 'Initials': 'LL', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University & The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, Chengdu 610041, China. Electronic address: yuhaishan117@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110009']
1743,32812652,Programmed intermittent boluses vs continuous epidural infusion in labor using an adrenaline containing solution: A randomized trial.,"BACKGROUND


Traditionally, epidural analgesia has been maintained using a continuous infusion (CEI) with the addition of patient-controlled boluses (PCEA). In recent years, programmed intermittent boluses (PIEB) has emerged as an alternative showing better efficacy in randomized studies. In this study, the aim was to test PIEB + PCEA vs CEI + PCEA using an epidural solution containing adrenaline.
METHODS


In total, 150 nulliparous and multiparous laboring women were randomized to maintain epidural analgesia with either PIEB + PCEA (5 ml bolus every hour, 5 ml PCEA bolus lockout 20 minutes) or CEI + PCEA (5 ml/h, 5 ml PCEA bolus, lockout 20 minutes) using a solution of bupivacaine 1mg/ml, fentanyl 2 mcg/ml and adrenaline 2 mcg/ml. The primary outcome was total hourly consumption of the epidural solution. Secondary outcomes included hourly pain scores, motor block at 60 minutes and 10 cm cervical dilation, maternal satisfaction, and the need for anesthetist intervention and time to this intervention.
RESULTS


We found no differences in hourly drug consumption between the groups (mean 9.0 ml/h (SD 3.7) (CEI group) vs. 8.1 ml/h (SD 2.0) (PIEB group), P = .08). We found a significant difference in number of successfully administered PCEA boluses (mean no. 3.9 (SD 4.1) (CEI group) vs. 1.9 (SD 2.0) (PIEB group), P < .001). We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention.
CONCLUSION


In this study, we found no clinically relevant differences using PIEB + PCEA compared to CEI + PCEA when using an epidural solution containing adrenaline.
EDITORIAL COMMENT


For labor epidural analgesia infusions, to optimize the analgesic effect, additional programmed intermittent boluses can be used as an alternative to patient-controlled boluses only. In this clinical trial, no differences in drug consumption or analgesic effect was observed when comparing these two different epidural bolus controls programs.",2020,"We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention.
","['150 nulliparous and multiparous', 'laboring women']","['maintain epidural analgesia with either PIEB+PCEA', 'CEI+PCEA', 'adrenaline containing solution', 'adrenaline', 'bupivacaine 1mg/ml, fentanyl 2 mcg/ml and adrenaline 2 mcg/ml', 'PIEB+PCEA vs CEI+PCEA']","['hourly drug consumption', 'total hourly consumption of the epidural solution', 'hourly pain scores, motor block at 60 minutes and 10 cm cervical dilation, maternal satisfaction, and the need for anesthetist intervention and time to this intervention', 'pain score, motor block, maternal satisfaction and the need for anesthetist intervention']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}]","[{'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.3965,"We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention.
","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Haidl', 'Affiliation': 'Department of Anesthesia, Akershus University hospital, Lørenskog, Norway.'}, {'ForeName': 'Leiv', 'Initials': 'L', 'LastName': 'Arne Rosseland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne-Marte', 'Initials': 'AM', 'LastName': 'Rørvik', 'Affiliation': 'Department of Anesthesia, Akershus University hospital, Lørenskog, Norway.'}, {'ForeName': 'Vegard', 'Initials': 'V', 'LastName': 'Dahl', 'Affiliation': 'Department of Anesthesia, Akershus University hospital, Lørenskog, Norway.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13689']
1744,32813915,Predictive variables for poor long-term physical recovery after intensive care unit stay: An exploratory study.,"BACKGROUND


Elucidating factors that influence physical recovery of survivors after an intensive care unit (ICU) stay is paramount in maximizing long-term functional outcomes. We examined potential predictors for poor long-term physical recovery in ICU survivors.
METHODS


Based on secondary analysis of a trial of 50 ICU patients who underwent mobilization in the ICU and were followed for one year, linear regression analysis examined the associations of exposure variables (baseline characteristics, severity of illness variables, ICU-related variables, and lengths of ICU and hospital stay), with physical recovery variables (muscle strength, exercise capacity, and self-reported physical function), measured one year after ICU discharge.
RESULTS


When the data were adjusted for age, female gender was associated with reduced muscle strength (P = .003), exercise capacity (P < .0001), and self-reported physical function (P = .01). Older age, when adjusted for gender, was associated with reduced exercise capacity (P < .001). After adjusting for gender and age, an association was observed between a lower score on one or two physical recovery variables and exposure variables, specifically, high body mass index, low functional independence, comorbidity and low self-reported physical function at baseline, muscle weakness at ICU discharge, and longer hospital stay. No adjustment was made for cumulative type I error rate due to small number of participants.
CONCLUSION


Elucidating risk factors for poor long-term physical recovery after ICU stay, including gender, may be critical if mobilization and exercise are to be prescribed expediently during and after ICU stay, to ensure maximal long-term recovery.",2020,", female gender was associated with reduced muscle strength (p=0.003), exercise capacity (p<0.0001) and self-reported physical function (p=0.01).","['50 ICU survivors', '50 ICU patients who underwent mobilisation in the ICU']",[],"['severity of illness variables, ICU-related variables, and lengths of ICU and hospital stay), with physical recovery variables (muscle strength, exercise capacity, and self-reported physical function', 'reduced muscle strength', 'cumulative type', 'exercise capacity (p<0.0001) and self-reported physical function', 'high body mass index, low functional independence, comorbidity and low self-reported physical function at baseline, muscle weakness at ICU discharge, and longer hospital stay']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",50.0,0.0304017,", female gender was associated with reduced muscle strength (p=0.003), exercise capacity (p<0.0001) and self-reported physical function (p=0.01).","[{'ForeName': 'Ólöf R', 'Initials': 'ÓR', 'LastName': 'Ámundadóttir', 'Affiliation': 'Department of Physiotherapy, Landspitali - The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Rannveig J', 'Initials': 'RJ', 'LastName': 'Jónasdóttir', 'Affiliation': 'Faculty of Nursing, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Kristinn', 'Initials': 'K', 'LastName': 'Sigvaldason', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Landspitali - The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Jónsdóttir', 'Affiliation': 'Faculty of Nursing, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Alma D', 'Initials': 'AD', 'LastName': 'Möller', 'Affiliation': 'Directorate of Health, Reykjavik, Iceland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Thorarinn', 'Initials': 'T', 'LastName': 'Sveinsson', 'Affiliation': 'Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Gísli H', 'Initials': 'GH', 'LastName': 'Sigurðsson', 'Affiliation': 'Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13690']
1745,32815991,Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.,"Importance


The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.
Objective


To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).
Design, Setting, and Participants


The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.
Interventions


Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.
Main Outcomes and Measures


The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.
Results


A total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, -0.8%; 95% CI, -6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, -9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, -2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.
Conclusions and Relevance


The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.
Trial Registration


ClinicalTrials.gov Identifier: NCT03007550.",2020,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","['214 patients', '105 patients in the LTG group and 109 patients in the OTG group', 'From January 2017 to September 2018, a total of 227 patients were enrolled', 'I Gastric Cancer', 'patients with clinical stage I gastric cancer']","['CLASS02', 'laparoscopic total gastrectomy (LTG', 'LTG', 'Laparoscopic vs Open Total Gastrectomy', 'LTG vs OTG with lymphadenectomy', 'conventional open total gastrectomy (OTG', 'OTG']","['overall morbidity and mortality rates', 'recovery courses and postoperative hospital stays', 'Intraoperative complications', 'mortality', 'distribution of complication severity', 'overall postoperative complication rate', 'morbidity and mortality', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}]","[{'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",227.0,0.250567,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","[{'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Peiwu', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of General Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Naiqing', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.3152']
1746,32816002,Associations of Variation in Retinal Thickness With Visual Acuity and Anatomic Outcomes in Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With Anti-Vascular Endothelial Growth Factor Agents.,"Importance


When initiating anti-vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes than eyes with less variation.
Objective


To investigate whether visual and anatomic outcomes in eyes with nAMD initiating anti-VEGF treatment are associated with fluctuations in retinal thickness.
Design, Setting, and Participants


In this study using data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included. Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020.
Main Outcomes and Measures


Foveal center point thicknesses (FCPTs) were extracted from 1165 study eyes from CATT and 566 study eyes from the IVAN trial, excluding those with 3 measurements or less. For each eye, the SD of FCPT was calculated. Eyes were grouped by FCPT SD quartile. Associations of FCPT SD quartile with outcomes were quantified at month 24 or the last available visit by linear or logistic regression, adjusting for baseline best-corrected visual acuity (BCVA) and randomized allocations to drug and treatment regimen, for BCVA, development of fibrosis, and development of macular atrophy.
Results


Of the 1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years. The median (interquartile range) FCPT SD was 40.2 (27.1-61.2) in the IVAN cohort and 59.0 (38.3-89.4) in the CATT cohort. After adjustment for baseline BCVA and trial allocations, BCVA worsened significantly across the quartiles of FCPT SD; the difference between the first and fourth quartiles was -6.27 Early Treatment Diabetic Retinopathy Study letters (95% CI, -8.45 to -4.09). The risk of developing fibrosis and macular atrophy also increased across FCPT SD quartiles. Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
Conclusions and Relevance


Greater variation in retinal thickness in eyes with nAMD during treatment with anti-VEGF was associated with worse BCVA and development of fibrosis and macular atrophy in these post hoc analyses, despite protocol-directed treatment frequency. Practitioners may want to consider variation in retinal thickness when advising patients about their prognosis.",2020,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","['1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years', 'Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020', 'eyes with nAMD initiating anti-VEGF treatment', 'Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included', 'patients with neovascular age-related macular degeneration (nAMD', 'Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With']","['anti-vascular endothelial growth factor (VEGF) treatment', 'Anti-Vascular Endothelial Growth Factor Agents']","['Measures\n\n\nFoveal center point thicknesses (FCPTs', 'risk of developing fibrosis and macular atrophy', 'median (interquartile range) FCPT SD']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0423421', 'cui_str': 'Atrophic macular change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.209385,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3001']
1747,32822076,Neuromuscular fatigability amplitude and aetiology are interrelated across muscles.,"NEW FINDINGS


What is the central question of this study? Is neuromuscular fatigability interrelated between different muscle groups from the same individual during isometric all-out exercise? What is the main finding and its importance? Although the average decrease can vary between muscles, an individual demonstrates interrelated fatigability aetiology regardless of the muscle group tested. The inter-individual variability provides evidence of different profiles common between muscles, which can be regarded as an individual characteristic.
ABSTRACT


Neuromuscular fatigability is commonly attributed to central and peripheral origins. However, there is strong evidence of interactions between these two mechanisms. According to the idea that peripheral fatigability might be centrally regulated, one can hypothesize that neuromuscular fatigability would be correlated between different muscle groups at the individual level. Thirty-two healthy participants (16 women and 16 men) completed two 5 min fatiguing exercises [60 isometric maximal voluntary contractions (MVCs)] with finger flexors (FFs) and ankle plantar flexors (PFs) in two randomized sessions. Neuromuscular testing was conducted before, during (every six MVCs) and directly after the fatigue procedure. The force asymptote (F A  ) was calculated as the asymptote of the force-time relationship. Changes (post- vs. pre-fatigue) in the exercise-evoked force (ΔDb 100  ), voluntary activation (ΔVA) and central activation ratio (∆CAR) were also investigated. Significant correlations were found between FFs and PFs for F A  , ΔDb 100  and ΔVA (r = 0.65, r = 0.63 and r = 0.50, respectively). A significant negative correlation between ∆CAR and ∆Db 100  was evidenced for both PFs (r = -0.82) and FFs (r = -0.57). Neuromuscular fatigability is correlated between different muscle groups at the individual level. The results support the idea that a restrained motor drive prevents large peripheral perturbations and that individuals exhibit correlated fatigability aetiology regardless of the muscle group tested. Widely different central/peripheral profiles can be found amongst individuals, and a part of the fatigability aetiology can be regarded as an individual characteristic.",2020,"Results Significant correlations were found between FF and PF for F A  , ΔDb 100  and ΔVA (r = ",['Methods Thirty-two healthy participants (16 women and 16 men'],['5\xa0min fatiguing exercises (60 isometric maximal voluntary contractions (MVC)) with finger flexors (FF) and ankle plantar flexors (PF'],"['exercise evoked force (ΔDb 100  ), voluntary activation (ΔVA) and central activation ratio (∆CAR']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",32.0,0.0203172,"Results Significant correlations were found between FF and PF for F A  , ΔDb 100  and ΔVA (r = ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chartogne', 'Affiliation': 'Movement, Interactions, Performance Laboratory, Le Mans University, Le Mans, France.'}, {'ForeName': 'Abderrahmane', 'Initials': 'A', 'LastName': 'Rahmani', 'Affiliation': 'Movement, Interactions, Performance Laboratory, Le Mans University, Le Mans, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Nicolon', 'Affiliation': 'Movement, Interactions, Performance Laboratory, Le Mans University, Le Mans, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Jubeau', 'Affiliation': 'Movement, Interactions, Performance Laboratory, Nantes University, Nantes, France.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Morel', 'Affiliation': 'Laboratoire Interuniversitaire de Biologie de la Motricité, Université Savoie Mont Blanc, Chambéry, France.'}]",Experimental physiology,['10.1113/EP088682']
1748,32816842,Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial.,"OBJECTIVE


To determine whether risk adapted intraoperative radiotherapy, delivered as a single dose during lumpectomy, can effectively replace postoperative whole breast external beam radiotherapy for early breast cancer.
DESIGN


Prospective, open label, randomised controlled clinical trial.
SETTING


32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada.
PARTICIPANTS


2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT).
INTERVENTIONS


Random allocation was to the EBRT arm, which consisted of a standard daily fractionated course (three to six weeks) of whole breast radiotherapy, or the TARGIT-IORT arm. TARGIT-IORT was given immediately after lumpectomy under the same anaesthetic and was the only radiotherapy for most patients (around 80%). TARGIT-IORT was supplemented by EBRT when postoperative histopathology found unsuspected higher risk factors (around 20% of patients).
MAIN OUTCOME MEASURES


Non-inferiority with a margin of 2.5% for the absolute difference between the five year local recurrence rates of the two arms, and long term survival outcomes.
RESULTS


Between 24 March 2000 and 25 June 2012, 1140 patients were randomised to TARGIT-IORT and 1158 to EBRT. TARGIT-IORT was non-inferior to EBRT: the local recurrence risk at five year complete follow-up was 2.11% for TARGIT-IORT compared with 0.95% for EBRT (difference 1.16%, 90% confidence interval 0.32 to 1.99). In the first five years, 13 additional local recurrences were reported (24/1140  v  11/1158) but 14 fewer deaths (42/1140  v  56/1158) for TARGIT-IORT compared with EBRT. With long term follow-up (median 8.6 years, maximum 18.90 years, interquartile range 7.0-10.6) no statistically significant difference was found for local recurrence-free survival (hazard ratio 1.13, 95% confidence interval 0.91 to 1.41, P=0.28), mastectomy-free survival (0.96, 0.78 to 1.19, P=0.74), distant disease-free survival (0.88, 0.69 to 1.12, P=0.30), overall survival (0.82, 0.63 to 1.05, P=0.13), and breast cancer mortality (1.12, 0.78 to 1.60, P=0.54). Mortality from other causes was significantly lower (0.59, 0.40 to 0.86, P=0.005).
CONCLUSION


For patients with early breast cancer who met our trial selection criteria, risk adapted immediate single dose TARGIT-IORT during lumpectomy was an effective alternative to EBRT, with comparable long term efficacy for cancer control and lower non-breast cancer mortality. TARGIT-IORT should be discussed with eligible patients when breast conserving surgery is planned.
TRIAL REGISTRATION


ISRCTN34086741, NCT00983684.",2020,TARGIT-IORT was non-inferior to EBRT:,"['Between 24 March 2000 and 25 June 2012, 1140 patients', 'patients with early breast cancer who met our trial selection criteria', 'early breast cancer', '2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either', '32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada']","['whole breast radiotherapy, or the TARGIT-IORT arm', 'risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT', 'EBRT', 'intraoperative radiotherapy during lumpectomy (TARGIT-IORT']","['mastectomy-free survival', 'local recurrence-free survival', 'breast cancer mortality', 'five year local recurrence rates', 'overall survival', 'local recurrence risk', 'distant disease-free survival', 'Mortality', 'deaths', 'local recurrences']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517539', 'cui_str': '1140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2298.0,0.234084,TARGIT-IORT was non-inferior to EBRT:,"[{'ForeName': 'Jayant S', 'Initials': 'JS', 'LastName': 'Vaidya', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK jayantvaidya@gmail.com.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Department of Biostatistics, University of Notre Dame, Fremantle, WA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baum', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Massarut', 'Affiliation': 'Department of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Pigorsch', 'Affiliation': 'Department of Gynaecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarado', 'Affiliation': 'Department of Surgery, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Douek', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'School of Surgery, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Henrik L', 'Initials': 'HL', 'LastName': 'Flyger', 'Affiliation': 'Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Department of Gynaecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Potyka', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'London, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sperk', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Laws', 'Affiliation': 'Department of Surgery, Royal Hampshire County Hospital, Winchester, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sütterlin', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Corica', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': ""Department of Oncology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'University of Southern California, John Wayne Cancer Institute & Helen Rey Breast Cancer Foundation, Los Angeles, CA, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Vinante', 'Affiliation': 'Department of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bozza', 'Affiliation': 'Instituto Oncologico Veneto, Padoa, Italy.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Pazos', 'Affiliation': 'Department of Radiation Oncology, University Hospital, The Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Le Blanc-Onfroy', 'Affiliation': 'Radiotherapy-Oncology, Western Cancer Institute, Nantes, France.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Breast Centre Seefeld, Zurich, Switzerland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Polkowski', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': 'Breast Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Niewald', 'Affiliation': 'Saarland University Medical Center, Homberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blohmer', 'Affiliation': 'Sankt Gertrauden Hospital, Charité, Medical University of Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCready', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hoefer', 'Affiliation': 'Sentara Surgery Specialists, Hampton, VA, USA.'}, {'ForeName': 'Pond', 'Initials': 'P', 'LastName': 'Kelemen', 'Affiliation': 'Ashikari Breast Center, New York Medical College, New York, NY, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Petralia', 'Affiliation': 'Department of Surgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Department of Pathology, University College London Hospitals, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Tobias', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m2836']
1749,32825990,Osteopathic treatment of patients with shoulder pain. A pragmatic randomized controlled trial.,"BACKGROUND


Shoulder complaints are common in the general population. Typically, the diagnosis of a specific pathology is lacking. The objective of this trial was to evaluate the effectiveness of an osteopathic treatment in patients suffering from shoulder pain.
METHODS


A pragmatic randomized controlled trial was conducted in patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS). Participants were identified from the general population in Germany and allocated by means of external randomization to an intervention group or a control group. Patients in the intervention group received five osteopathic treatments at intervals of two weeks. Treatment was custom tailored and based on osteopathic principles. Controls received their osteopathic treatment after an 8-week untreated waiting period. Primary outcome parameters were pain intensity and frequency, measured by VAS and Likert Scales. Secondary outcome parameters were shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36).
RESULTS


A total of 70 patients aged 25-70 years (average age 45.6 ± 13.4 years) were included, 36 in the intervention group and 34 in the control group. The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005). The proportion of participants with a low frequency of pain increased in the osteopathic group only (from 7 to 34 vs. 9 to 6 in the control group, p = 0.006), and the number of patients with a high frequency decreased in the osteopathic group only (from 29 to 2 vs. 25 to 28, p < 0.0005). Shoulder specific pain and disability also improved. The follow-up assessment in the intervention group showed further improvements.
CONCLUSIONS


Five osteopathic treatments over a period of eight weeks led to statistically significant and clinically relevant positive changes of pain and disability in patients suffering from shoulder pain.",2020,The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005).,"['patients suffering from shoulder pain', '70 patients aged 25-70 years (average age 45.6\xa0±\xa013.4 years) were included, 36 in the intervention group and 34 in the control group', 'patients with shoulder pain', 'patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS']","['control group', 'osteopathic treatment']","['average pain intensity (VAS', 'pain and disability', 'shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36', 'maximal pain intensity (VAS', 'Shoulder specific pain and disability', 'pain intensity and frequency, measured by VAS and Likert Scales', 'low frequency of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]",70.0,0.16424,The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005).,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schwerla', 'Affiliation': 'German Academy of Osteopathy, Research Commission, Gauting, Germany. Electronic address: f.schwerla@german-afo.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Hinse', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: torsten.hinse@gmx.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Klosterkamp', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: markus.klosterkamp@t-online.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmitt', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: osteopathie-schmitt@web.de.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Rütz', 'Affiliation': 'German Academy of Osteopathy, Research Commission, Gauting, Germany. Electronic address: m.ruetz@osteopathie-akademie.de.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Resch', 'Affiliation': 'German Institute for Health Research (DIG), Bad Elster, Germany. Electronic address: K.L.Resch@t-online.de.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.009']
1750,32825994,Neuromuscular activation analysis of the trunk muscles during hippotherapy sessions.,"INTRODUCTION


Hippotherapy allows the development of affective, sensory, motor, and cognitive areas, besides providing the practitioner with several movements and stimuli necessary for therapeutic progress. However, there is a limited amount of scientific evidence regarding the suitability of the mount material, mount type, and hippotherapy session duration, as well as regarding the activation of specific muscle groups during the practice and its applicability to activities of daily living.
OBJECTIVE


This study aimed to study the neuromuscular activation behavior of the iliocostalis, longissimus, multifidus, and upper trapezius muscles of children during four hippotherapy session time points using a functional task. It also compared two different mount materials for riding.
METHODOLOGY


A total of 30 children were randomly assigned to one of three groups: Saddle Hippotherapy Group, Blanket Hippotherapy Group, and Control Group. Data were collected with an electromyograph in a functional task that comprised trunk movements to pick up an object. Assessments took place at four times during the session.
RESULTS


There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session. The trapezius muscle showed increased neuromuscular activation after only 10 min. It continued to increase (but without a statistical difference) after and 20 and 30 min.
CONCLUSION


Hippotherapy promoted neuromuscular activation of the trunk muscles in children, assessed through a functional task, and was influenced by both session time and mount material. Specifically, the greater neuromuscular performance occurred when an exercise was performed using saddle and stirrup and lasted 30 min.",2020,"There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session.","['30 children', 'children during four hippotherapy session time points using a functional task']","['Saddle Hippotherapy Group, Blanket Hippotherapy Group, and Control Group', 'electromyograph', 'Hippotherapy']","['neuromuscular activation', 'neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles', 'neuromuscular performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}]","[{'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}]",30.0,0.0185116,"There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session.","[{'ForeName': 'Júlio Ribeiro', 'Initials': 'JR', 'LastName': 'Bravo Gonçalves Junior', 'Affiliation': 'Federal University of Viçosa, Brazil. Electronic address: julioebravo@yahoo.com.br.'}, {'ForeName': 'André Gustavo', 'Initials': 'AG', 'LastName': 'Fernandes de Oliveira', 'Affiliation': 'Federal University of Juiz de Fora, Brazil.'}, {'ForeName': 'Silvia Almeida', 'Initials': 'SA', 'LastName': 'Cardoso', 'Affiliation': 'Federal University of Viçosa, Brazil.'}, {'ForeName': 'Kamila Gabriela', 'Initials': 'KG', 'LastName': 'Jacob', 'Affiliation': 'Dinâmica of Vale of Piranga of Ponte Nova University, Brazil.'}, {'ForeName': 'Lucas Vilas', 'Initials': 'LV', 'LastName': 'Boas Magalhães', 'Affiliation': 'Federal University of Viçosa, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.029']
1751,32825996,Effects of dry needling on symptomatic hallux valgus: A randomized single blind clinical trial.,"OBJECTIVES


The purpose of the present study was to determine the short and medium effects of dry needling (DN) on myofascial trigger points (MTrPs) in individuals with symptomatic hallux valgus (SHV).
METHODS


A total of 30 female volunteers, aged 25-60, with hallux valgus (HV) were randomly divided into two groups: DN group (n = 15) and control group (n = 15) who received sham dry needling. The outcome measures were pain intensity (Visual Analogue Scale, VAS), Foot Function Index (FFI), hallux valgus angle (HVA), and first metatarsophalangeal joint radiography.
RESULTS


At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05). These findings were maintained for a week and a month during follow-ups.
CONCLUSION


According to the findings, dry needling can be recommended for improving first metatarsophalangeal joint alignment in the mild to moderate SHV individuals.",2020,"At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05).","['30 female volunteers, aged 25-60, with hallux valgus (HV', 'symptomatic hallux valgus', 'individuals with symptomatic hallux valgus (SHV']","['dry needling', 'DN group (n\xa0=\xa015) and control group (n\xa0=\xa015) who received sham dry needling', 'dry needling (DN']","['pain intensity and foot function', 'myofascial trigger points (MTrPs', 'pain intensity (Visual Analogue Scale, VAS), Foot Function Index (FFI), hallux valgus angle (HVA), and first metatarsophalangeal joint radiography']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal joint structure'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]",30.0,0.0274087,"At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05).","[{'ForeName': 'Aliye Sadat', 'Initials': 'AS', 'LastName': 'Kharazmi', 'Affiliation': 'School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Okhovatian', 'Affiliation': 'Physiotherapy Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: farshadokhovatian1965@gmail.com.'}, {'ForeName': 'Alireza Akbarzadeh', 'Initials': 'AA', 'LastName': 'Baghban', 'Affiliation': 'Proteomics Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh Mohammadi', 'Initials': 'MM', 'LastName': 'Kojidi', 'Affiliation': 'Physiotherapy Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Azimi', 'Affiliation': 'Department of English Language Teaching, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.016']
1752,32826000,"The effectiveness of biomechanical taping and Kinesiotaping on shoulder pain, active range of motion and function of participants with Trapezius Myalgia: A randomized controlled trial.","BACKGROUND


Trapezius Myalgia (TM) is characterized by shoulder pain and dysfunction. Kinesio Taping is commonly used in symptom management of TM. Biomechanical Taping (BMT), a novel intervention, may provide equally effective management.
OBJECTIVES


This paper reports on the effectiveness of Biomechanical Taping compared with Kinesio Taping in improving shoulder pain, active range of motion (AROM), and function.
METHODS


Two groups of participants with TM were recruited through simple random sampling of participants from nine call centers and purposively-sampled participants from one fast-food chain and one community based rehabilitation center in Manila, Philippines. Participants were randomly allocated to either Kinesio Taping or biomechanical taping group in a double-blind clinical trial. Irrespective of the type of taping, participants performed gentle passive stretching of upper trapezius for six times each held for 30 s on Days 1, 3, and 5. On Days 2 and 4, participants performed gentle passive stretch of upper trapezius three times a day. Pre- and post-intervention measures were taken of Visual Analogue Scale for pain intensity, AROM for shoulder movement, and Disability of Arm, Shoulder, and Hand for function.
RESULTS


Of 68 participants, 62 had shoulder symptoms secondary to TM. Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
CONCLUSION


Biomechanical Taping appears to be as effective as Kinesio Taping in the short term in decreasing pain and improving function of individuals with TM. Both taping techniques did not restrict shoulder AROM of included participants.
MESH TERMS


Athletic Tape, Myalgia, Pain Measurements, Shoulder Pain NON-MESH TERMS: Biomechanical Taping Technique.",2020,"Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
","['Two groups of participants with TM were recruited through simple random sampling of participants from nine call centers and purposively-sampled participants from one fast-food chain and one community based rehabilitation center in Manila, Philippines', '68 participants, 62 had shoulder symptoms secondary to TM', 'participants with Trapezius Myalgia']","['Biomechanical Taping', 'MESH', 'Kinesio Taping or biomechanical taping', 'Biomechanical Taping (BMT', 'biomechanical taping and Kinesiotaping', 'Biomechanical Taping Technique', 'Shoulder Pain NON-MESH TERMS', 'Kinesio Taping']","['Visual Analogue Scale for pain intensity, AROM for shoulder movement, and Disability of Arm, Shoulder, and Hand for function', 'Athletic Tape, Myalgia, Pain Measurements', 'shoulder pain, active range of motion and function', 'shoulder pain, active range of motion (AROM), and function', 'Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2350263', 'cui_str': 'Orthotic Tape'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",68.0,0.164617,"Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
","[{'ForeName': 'Valentin C', 'Initials': 'VC', 'LastName': 'Dones Iii', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines; Center for Health Research and Movement Science, College of Rehabilitation Sciences, University of Santo Tomas, Philippines. Electronic address: vcdones@ust.edu.ph.'}, {'ForeName': 'Jocel M', 'Initials': 'JM', 'LastName': 'Regino', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines; Center for Health Research and Movement Science, College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Nicole Trizia S', 'Initials': 'NTS', 'LastName': 'Esplana', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Ivan Rafael V', 'Initials': 'IRV', 'LastName': 'Rivera', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Melissa Kaye R', 'Initials': 'MKR', 'LastName': 'Tomas', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.004']
1753,32826011,"The immediate effect of lumbopelvic manipulation on knee pain, knee position sense, and balance in patients with patellofemoral pain: A randomized controlled trial.","BACKGROUND


Patellofemoral pain (PFP) is a common musculoskeletal disorder. Quadriceps and core muscle neuromuscular control impairments are frequently associated with PFP. Lumbopelvic manipulation (LPM) has been shown to improve quadriceps and core muscle activation and decrease their inhibition, but changes in balance and knee joint position sense (JPS) after this intervention remain unknown.
OBJECTIVE


To determine whether LPM decreases knee pain and JPS error and increases balance performance in patients with PFP.
DESIGN


Randomized controlled trial.
SETTING


Biomechanics laboratory at a rehabilitation science research center.
METHODS


Forty-four patients with PFP participated in this study that randomly divided into two equal groups. One group received LPM and the other received sham LPM (positioning with no thrust) in a single session. At baseline and immediately after the intervention, the outcomes of pain using a visual analog scale, balance using the modified star excursion balance test (mSEBT), and JPS at 20° and 60° of knee flexion using a Biodex dynamometer.
RESULTS


There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention. In addition, we observed significant differences between groups in pain, balance control (anterior direction) and JPS at 60° of knee flexion immediately after the intervention.
CONCLUSION


A single session of LPM immediately improved balance control, knee JPS, and pain in patients diagnosed with PFP.
CLINICAL REHABILITATION IMPACT


Findings suggest that LPM may be used as a therapeutic tool for immediate improvement of symptoms of PFP. However, more research is needed to determine long term results.",2020,"There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention.","['patients with patellofemoral pain', 'patients diagnosed with PFP', 'patients with PFP', 'Biomechanics laboratory at a rehabilitation science research center', 'Forty-four patients with PFP participated']","['Lumbopelvic manipulation (LPM', 'LPM', 'sham LPM', 'lumbopelvic manipulation']","['knee pain, knee position sense, and balance', 'balance performance', 'pain, balance control (anterior direction) and JPS', 'pain using a visual analog scale, balance using the modified star excursion balance test (mSEBT), and JPS at 20° and 60° of knee flexion using a Biodex dynamometer', 'balance control, knee JPS, and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",44.0,0.0687298,"There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motealleh', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Abbasi', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: leabbasi@sums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.006']
1754,32826014,The effect of Kinesio-tape® on pain and vertical jump performance in active individuals with patellar tendinopathy.,"BACKGROUND


Patellar tendinopathy is a common inflammatory condition in athletes who undergo large volumes of running and jumping. Kinesio-tape® (KT) is proposed to provide pain relief; however, its effect has not been examined on patellar tendinopathy.
OBJECTIVE


To examine the effects of KT on pain modulation for active individuals with patellar tendinopathy during functional activities.
METHODS


Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included. Participants underwent three data collection sessions with KT, sham, and no tape (NT) in a randomized order. During the session, participants performed a maximum vertical jump, single-leg squats and isometric knee extension. The KT intervention was applied according to the KT manual and the sham utilized the same pattern without tension. Pain level was evaluated using the numeric pain scale before, during and after each activity. Function was assessed as maximum vertical jump height and maximum isometric strength. A separate repeated measures ANOVA was used to compare each dependent variable (pain level, vertical jump height, and isometric strength) among the conditions.
RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22). Significantly lower jump heights were found under KT (17.73 ± 3.06in) during the maximum vertical jump test compared to sham (18.65 ± 2.17in, p = 0.000) and NT (18.18 ± 2.93in, p = 0.008).
CONCLUSIONS


The use of the KT tape with a tendon corrective strip and muscle facilitative strip was effective for decreasing pain associated with patellar tendinopathy during jump landing but led to decreased maximum jump height.
CLINICAL TRIAL IDENTIFIER


NCT04153877.",2020,"RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22).","['athletes who undergo large volumes of running and jumping', 'Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included', 'active individuals with patellar tendinopathy', 'active individuals with patellar tendinopathy during functional activities']","['KT', 'Kinesio-tape®', 'KT tape with a tendon corrective strip and muscle facilitative strip', 'KT, sham, and no tape (NT', 'KT intervention', 'Kinesio-tape® (KT']","['pain scores', 'pain modulation', 'variable (pain level, vertical jump height, and isometric strength', 'pain and vertical jump performance', 'numeric pain scale', 'maximum vertical jump height and maximum isometric strength', 'Pain level', 'jump heights']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",13.0,0.0538643,"RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22).","[{'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: ktamura@hawaii.edu.'}, {'ForeName': 'Portia B', 'Initials': 'PB', 'LastName': 'Resnick', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, 1250 Bellflower Boulevard, Long Beach, CA, 90804, USA. Electronic address: portia.resnick@csulb.edu.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Hamelin', 'Affiliation': 'Department of Athletics, Florida Atlantic University, 777 Glades Rd, Boca Raton, FL, 33431, USA. Electronic address: bhamelin@fau.edu.'}, {'ForeName': 'Yukiya', 'Initials': 'Y', 'LastName': 'Oba', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: yukiya@hawaii.edu.'}, {'ForeName': 'Ronald K', 'Initials': 'RK', 'LastName': 'Hetzler', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: hetzler@hawaii.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Stickley', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: cstickle@hawaii.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.005']
1755,32826015,The immediate effect of IASTM vs. Vibration vs. Light Hand Massage on knee angle repositioning accuracy and hamstrings flexibility: A pilot study.,"INTRODUCTION


The effectiveness of novel soft-tissue interventions relative to traditional ones requires further exploration. The purpose of this pilot study was to evaluate the immediate effect of Instrument Assisted Soft Tissue Mobilization (IASTM) compared to Vibration Massage or Light Hand Massage on hamstrings' flexibility and knee proprioception.
METHODS


16 healthy non-injured male participants (mean age 23.7 years, height 1.80 cms and body mass 77.7 kg) were randomly assigned to the following interventions: (a) 5min IASTM, (b) 5min Vibration Massage and (c) 8min Light Hand-Massage, sequentially delivered to all participants with an in-between 1-week time interval. A single application of each intervention was given over the hamstrings of their dominant leg (repeated measures under 3 different experimental conditions). An active knee angle reproduction proprioception test and the back-saver sit and reach flexibility test were performed before and immediately after each intervention. Reliability of outcomes was also assessed.
RESULTS


Reliability for flexibility (ICC 3,1  = 0.97-0.99/SEM = 0.83-1.52 cm) and proprioception (ICC 3,1  = 0.83-0.88/SEM = 1.63-2.02°) was very good. For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences. For proprioception, improvement in the IASTM (2.12°), Vibration Massage (0.32°) and Light Hand-Massage (1.17°) conditions was not statistically significant; no between-group differences were also evident.
CONCLUSIONS


Our findings indicate that muscle flexibility was positively influenced immediately after a single intervention of IASTM, Vibration Massage or Light Hand Massage. Proprioception changes were not statistically significant either within or between groups. Further evaluation of those interventions in a larger population with hamstrings pathology is required.",2020,"For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences.","['16 healthy non-injured male participants ', 'mean age 23.7 years, height 1.80\xa0cms and body mass 77.7\xa0kg']","['Instrument Assisted Soft Tissue Mobilization (IASTM', 'novel soft-tissue interventions', 'IASTM vs. Vibration vs. Light Hand Massage', 'Vibration Massage or Light Hand Massage', '5min IASTM, (b) 5min Vibration Massage and (c) 8min Light Hand-Massage']","['knee angle repositioning accuracy and hamstrings flexibility', 'Proprioception changes', 'Vibration Massage', 'muscle flexibility']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0041718', 'cui_str': 'Centers for Medicare and Medicaid Services'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",16.0,0.0143657,"For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Koumantakis', 'Affiliation': '401 General Army Hospital of Athens, Physiotherapy Department, Pan. Kanellopoulou 1, Athens, Greece; Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK. Electronic address: g.koumantakis2@gmail.com.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Roussou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Angoules', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Nikolaos A', 'Initials': 'NA', 'LastName': 'Angoules', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Alexandropoulos', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Mavrokosta', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Prokopios', 'Initials': 'P', 'LastName': 'Nikolaou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Filippi', 'Initials': 'F', 'LastName': 'Karathanassi', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papadopoulou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.007']
1756,32842248,[Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion in the management of women with placenta accreta spectrum:a randomized controlled trial].,"Objective:  To access the effectiveness and safety of the intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion in the management of placenta accreta spectrum (PAS).  Methods:  This was an open-label, randomized controlled trial conducted in Nanjing Drum Tower Hospital. The patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018. When bleeding could not be achieved after fetus delivered, and a temporary abdominal aortic balloon occlusion and the compression sutures as needed, the women were randomly allocated 1∶1 into balloon tamponade ( n =81) or gauze packing ( n =80) group. The primary outcome was successful bleeding arrests by avoiding second line surgeries. The secondary outcomes included the volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications.  Results:  All the women [100% (81/81)] in the balloon group were obtained hemostasis without further intervention, significantly higher than 88% (70/80) in the gauze group ( P =0.001). Before uterine tamponade, blood loss were 820 ml (620-1 230) ml and 850 ml (605-1 442) ml, while placenta bed were sutured in 96%（78/81, 77/80） respectively ( P >0.05).The proportion of blood loss≥1 000 ml was higher in the gauze group than that in the balloon group ( P =0.006). Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain occurred more frequently in the gauze group ( P< 0.05). The following outcome showed no statistically significant difference between the two groups: the vascular occlusion time, the dose of radiation, and interventional radiology complication ( P >0.05). The median volume infused into the lower and upper balloons is 70 ml (50-100 ml) and 180 ml (100-240 ml).  Conclusions:  Incrauterine balloon tamponade is as effective as gauze packing in hemostasis following the placenta delivery in PAS. Compared with gauze packing, the uterine balloon tamponade is more effective.",2020,ml was higher in the gauze group than that in the balloon group ( P =0.006).,"['patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018', 'Nanjing Drum Tower Hospital', 'women with placenta accreta spectrum']","['balloon tamponade', 'Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion', 'gauze packing', 'intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion', 'Incrauterine balloon tamponade']","['volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications', 'successful bleeding arrests by avoiding second line surgeries', 'Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain', 'obtained hemostasis', 'vascular occlusion time, the dose of radiation, and interventional radiology complication', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030125', 'cui_str': 'aminosalicylic acid'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032044', 'cui_str': 'Placenta accreta'}]","[{'cui': 'C2930473', 'cui_str': 'Balloon Tamponade'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0042553', 'cui_str': 'Versed'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0848200', 'cui_str': 'Afterbirth pain'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0034602', 'cui_str': 'Interventional radiology - specialty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",,0.206593,ml was higher in the gauze group than that in the balloon group ( P =0.006).,"[{'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Dai', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Obstetrics and Gynecology, Taizhou People's Hospital of Jiangsu Province, Taizhou 225300, China.""}, {'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'X B', 'Initials': 'XB', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Department of Radiology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gu', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Hu', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing 210008, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200225-00135']
1757,32842812,Asymmetric dimethylarginine predicts perioperative cardiovascular complications in patients undergoing medium-to-high risk non-cardiac surgery.,"OBJECTIVES


Perioperative cardiovascular events remain an important factor that affects surgery outcome. We assessed if asymmetric dimethylarginine (ADMA), an endogenous inhibitor of nitric oxide synthesis, predicts perioperative risk, and if pre-operative supplementation with L-arginine/L-citrulline improves the plasma L-arginine/ADMA ratio.
METHODS


In this prospective study, planned thoracic and/or abdominal surgery patients were randomized to receive L-arginine/L-citrulline (5 g/day) or placebo 1 to 5 days before surgery. We measured perioperative plasma ADMA and L-arginine levels. The primary outcome was a 30-day combined cardiovascular endpoint.
RESULTS


Among 269 patients, 23 (8.6%) experienced a major adverse cardiovascular event. ADMA and C-reactive protein were significantly associated with the incidence of cardiovascular complications in the multivariable-adjusted analysis. The L-arginine plasma concentration was significantly higher on the day of surgery with L-arginine/L-citrulline supplementation compared with placebo. In patients with high pre-operative ADMA, there was a non-significant trend towards reduced incidence of the primary endpoint with L-arginine/L-citrulline supplementation (six vs. nine events).
CONCLUSIONS


ADMA is a predictor of major adverse cardiovascular complications in the perioperative period for patients who are undergoing major abdominal and/or thoracic surgery. Supplementation with L-arginine/L-citrulline increased the L-arginine plasma concentration, enhanced the L-arginine/ADMA ratio, and induced a trend towards fewer perioperative events.",2020,The L-arginine plasma concentration was significantly higher on the day of surgery with L-arginine/L-citrulline supplementation compared with placebo.,"['patients who are undergoing major abdominal and/or thoracic surgery', 'patients undergoing medium-to-high risk non-cardiac surgery', 'planned thoracic and/or abdominal surgery patients']","['placebo', 'Asymmetric dimethylarginine', 'L-arginine/L-citrulline']","['perioperative plasma ADMA and L-arginine levels', 'asymmetric dimethylarginine (ADMA', 'L-arginine plasma concentration', 'L-arginine/L-citrulline supplementation', 'ADMA and C-reactive protein', 'plasma L-arginine/ADMA ratio', 'cardiovascular complications', 'major adverse cardiovascular event', '30-day combined cardiovascular endpoint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0161816', 'cui_str': 'Cardiac complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",269.0,0.354141,The L-arginine plasma concentration was significantly higher on the day of surgery with L-arginine/L-citrulline supplementation compared with placebo.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Appel', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Anesthesiology, Hamburg, DE, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Böger', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, DE, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Windolph', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, DE, Germany.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Heinze', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Anesthesiology, Hamburg, DE, Germany.'}, {'ForeName': 'Alwin E', 'Initials': 'AE', 'LastName': 'Goetz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Anesthesiology, Hamburg, DE, Germany.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Hannemann', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, Hamburg, DE, Germany.'}]",The Journal of international medical research,['10.1177/0300060520940450']
1758,32844550,Postprandial Triglyceride-Rich Lipoproteins from Type 2 Diabetic Women Stimulate Platelet Activation Regardless of the Fat Source in the Meal.,"SCOPE


The aim of this study is to examine whether postprandial (PP) triglyceride-rich lipoproteins (TGRL) secreted after a moderate fat intake would activate platelets differently according to their fatty acid (FA) composition.
METHODS AND RESULTS


In a parallel single-blind randomized trial, 30 women with type 2 diabetes are assigned a breakfast containing 20 g lipids from butter versus hazelnut-cocoa spread (HCS) rich in palm oil. Blood samples are collected at fasting and 4 h PP. FA composition of fasting and PP TGRL and their effects on the activation of platelets from healthy blood donors are assessed. Both breakfasts similarly increase plasma ApoB-48, plasma, and TGRL triglycerides (p < 0.05). TGRL mean diameter increases after both breakfasts and is greater after the butter breakfast. Both breakfasts are rich in palmitic acid, and the HCS breakfast contains 45% oleic acid. TGRL FA composition reflects the dietary FA composition. Pre-incubation of platelets with fasting and PP TGRL increases collagen-stimulated aggregation (p < 0.01 vs control). Fasting and PP TGRL similarly increase agonist-induced thromboxane B 2  concentrations, and this effect is concentration-dependent for PP TGRL.
CONCLUSION


PP TGRL from type 2 diabetic women after a palm-oil spread versus butter-based mixed meal induce similar acute in vitro platelet activation.",2020,"Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05).",['30 women with type 2 diabetes'],"['breakfast containing 20 g lipids from butter vs hazelnut cocoa spread rich in palm oil', 'PP TGRL']","['Postprandial Triglyceride-Rich Lipoproteins', 'incubation of platelets with fasting and PP TGRL increased collagen-stimulated aggregation', 'Blood samples', 'plasma ApoB-48, plasma and TGRL triglycerides', 'FA composition of fasting and PP TGRL', 'Platelet Activation', 'postprandial (PP) triglyceride-rich lipoproteins (TGRL', 'TGRL mean diameter']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450403', 'cui_str': '20G'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0006494', 'cui_str': 'Butter'}, {'cui': 'C0440288', 'cui_str': 'Hazelnut'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0069962', 'cui_str': 'Palm Oil'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1096194', 'cui_str': 'Lipoprotein (a) increased'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0103839', 'cui_str': 'Apolipoprotein B-48'}, {'cui': 'C0065060', 'cui_str': 'lipoprotein triglyceride'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",30.0,0.059224,"Both breakfasts similarly increased plasma ApoB-48, plasma and TGRL triglycerides (p<0.05).","[{'ForeName': 'Marie Michèle', 'Initials': 'MM', 'LastName': 'Boulet', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheillan', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Di Filippo', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Taïssia', 'Initials': 'T', 'LastName': 'Lelekov-Boissard', 'Affiliation': ""Fédération d'endocrinologie, Maladies Métaboliques, Diabète et Nutrition, Hôpital Louis Pradel, Hospices Civils de Lyon, Bron, 69500, France.""}, {'ForeName': 'Charline', 'Initials': 'C', 'LastName': 'Buisson', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, CENS, FCRIN/FORCE Network, Pierre Bénite, 69310, France.'}, {'ForeName': 'Julie-Anne', 'Initials': 'JA', 'LastName': 'Nazare', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, CENS, FCRIN/FORCE Network, Pierre Bénite, 69310, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tressou', 'Affiliation': 'UMR MIA-Paris, AgroParisTech, INRAE, Paris-Saclay University, Paris, 75005, France.'}, {'ForeName': 'Marie-Caroline', 'Initials': 'MC', 'LastName': 'Michalski', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Calzada', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moulin', 'Affiliation': 'Univ-Lyon, CarMeN Laboratory, Inserm U1060, INRAE UMR 1397, INSA Lyon, CENS-ELI Building 165 chemin du Grand Revoyet, Pierre-Bénite, 69310, France.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000694']
1759,32844909,Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial.,"OBJECTIVES


compare an accelerated physiotherapeutic protocol to a conventional physiotherapeutic protocol in total hip arthroplasty patients.
METHODS


a randomized double blinded clinical trial performed from August 2013 to November 2014. Forty-eight patients diagnosed with hip osteoarthritis submitted to a total hip arthroplasty surgery. An accelerated rehabilitation physiotherapy applied three times a day and start gait training on the first day or standard physiotherapy applied once a day and start gait training on the second or third day of hospitalization. The Merle dAubigné and Postel score (mobility, pain and gait), muscle strength force, range of motion, in hospital stay and time to start of gait training, were the outcomes.
RESULTS


the mean age was 64.46 years (10.37 years standard deviation). No differences were observed in age in different genders, and the two randomization groups were homogeneous. In hospital stay was lower in the intervention group compared to the control group, 3 (3-4) days [median (interquartile range)] versus 4 (4-5) days. Time to the start of gait training was early in the intervention group compared to the control group, 1 (1-1) days versus 2 (2-2) days. Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
CONCLUSIONS


an accelerated physiotherapeutic protocol should be encouraged, because it shows favourable results in gait, muscle strength and length of hospital stay, even upon hospital discharge.",2020,"Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
","['the mean age was 64.46 years (10.37 years standard deviation', 'total hip arthroplasty patients', 'total hip arthroplasty (ARTHA', 'August 2013 to November 2014', 'Forty-eight patients diagnosed with hip osteoarthritis submitted to a total hip arthroplasty surgery']","['conventional physiotherapeutic protocol', 'Accelerated rehabilitation versus conventional rehabilitation']","['Higher muscle strength values', 'Time to the start of gait training', 'Merle dAubigné and Postel score (mobility, pain and gait), muscle strength force, range of motion, in hospital stay and time to start of gait training', 'hospital stay']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",48.0,0.111212,"Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction.
","[{'ForeName': 'Angela Elizabeth', 'Initials': 'AE', 'LastName': 'Marchisio', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Tiango Aguiar', 'Initials': 'TA', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina Sant Anna', 'Initials': 'CSA', 'LastName': 'Umpierres', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'LÍvia', 'Initials': 'L', 'LastName': 'GalvÃo', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rosito', 'Affiliation': 'Hip Surgery of the Department of Orthopedic Surgery, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Carlos Alberto DE Souza', 'Initials': 'CAS', 'LastName': 'Macedo', 'Affiliation': 'Hip Surgery of the Department of Orthopedic Surgery, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brasil.'}, {'ForeName': 'Carlos Roberto', 'Initials': 'CR', 'LastName': 'Galia', 'Affiliation': 'Postgraduate Program in Medicine: Surgical Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20202548']
1760,32845061,"Machine learning risk score for prediction of gestational diabetes in early pregnancy in Tianjin, China.","AIMS


This study aimed to develop a machine learning-based prediction model for gestational diabetes mellitus (GDM) in early pregnancy in Chinese women.
MATERIALS AND METHODS


We used an established population-based prospective cohort of 19,331 pregnant women registered as pregnant before the 15th gestational week in Tianjin, China, from October 2010 to August 2012. The dataset was randomly divided into a training set (70%) and a test set (30%). Risk factors collected at registration were examined and used to construct the prediction model in the training dataset. Machine learning, that is, the extreme gradient boosting (XGBoost) method, was employed to develop the model, while a traditional logistic model was also developed for comparison purposes. In the test dataset, the performance of the developed prediction model was assessed by calibration plots for calibration and area under the receiver operating characteristic curve (AUR) for discrimination.
RESULTS


In total, 1484 (7.6%) women developed GDM. Pre-pregnancy body mass index, maternal age, fasting plasma glucose at registration, and alanine aminotransferase were selected as risk factors. The machine learning XGBoost model-predicted probability of GDM was similar to the observed probability in the test data set, while the logistic model tended to overestimate the risk at the highest risk level (Hosmer-Lemeshow test p value: 0.243 vs. 0.099). The XGBoost model achieved a higher AUR than the logistic model (0.742 vs. 0.663, p < 0.001). This XGBoost model was deployed through a free, publicly available software interface (https://liuhongwei.shinyapps.io/gdm_risk_calculator/).
CONCLUSION


The XGBoost model achieved better performance than the logistic model.",2020,"The XGBoost model achieved a higher AUR than the logistic model (0.742 vs. 0.663, P < 0.001).","['gestational diabetes mellitus (GDM) in early pregnancy in Chinese women', '19331 pregnant women registered as pregnant before the 15 th  gestational week in Tianjin, China, from October 2010 to August 2012', 'gestational diabetes in early pregnancy in Tianjin, China']","['machine learning-based prediction model', 'Machine learning risk score']","['GDM. Pre-pregnancy body mass index (BMI), maternal age, fasting plasma glucose at registration, and alanine aminotransferase (ALT']","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",19331.0,0.0253115,"The XGBoost model achieved a higher AUR than the logistic model (0.742 vs. 0.663, P < 0.001).","[{'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jinnan', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Tianjin Women and Children's Health Center, Tianjin, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Juliana Cn', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3397']
1761,32820838,Achieving energy balance with a high-fat meal does not enhance skeletal muscle adaptation and impairs glycaemic response in a sleep-low training model.,"NEW FINDINGS


What is the central question of this study? Does achieving energy balance mainly with ingested fat in a 'sleep-low' model of training with low muscle glycogen affect the early training adaptive response during recovery? What is the main finding and its importance? Replenishing the energy expended during exercise mainly from ingested fat to achieve energy balance in a 'sleep-low' model does not enhance the response of skeletal muscle markers of early adaptation to training and impairs glycaemic control the morning after compared to training with low energy availability. These findings are important for optimizing post-training dietary recommendations in relation to energy balance and macronutrient intake.
ABSTRACT


Training with low carbohydrate availability (LCHO) has been shown to acutely enhance endurance training skeletal muscle response, but the concomitant energy deficit (ED) in LCHO interventions has represented a confounding factor in past research. This study aimed at determining if achieving energy balance with high fat (EB-HF) acutely enhances the adaptive response in LCHO compared to ED with low fat (ED-LF). In a crossover design, nine well-trained males completed a 'sleep-low' protocol: on day 1 they cycled to deplete muscle glycogen while reaching a set energy expenditure (30 kcal (kg of fat free mass (FFM)) -1  ). Post-exercise, low carbohydrate, protein-matched meals completely (EB-HF, 30 kcal (kg FFM) -1  ) or partially (ED-LF, 9 kcal (kg FFM) -1  ) replaced the energy expended, with the majority of energy derived from fat in EB-HF. In the morning of day 2, participants exercised fasted, and skeletal muscle and blood samples were collected and a carbohydrate-protein drink was ingested at 0.5 h recovery. Muscle glycogen showed no treatment effect (P < 0.001) and decreased from 350 ± 98 to 192 ± 94 mmol (kg dry mass) -1  between rest and 0.5 h recovery. Phosphorylation status of the mechanistic target of rapamycin and AMP-activated protein kinase pathway proteins showed only time effects. mRNA expression of p53 increased after exercise (P = 0.005) and was higher in ED-LF at 3.5 h compared to EB-HF (P = 0.027). Plasma glucose and insulin area under the curve (P < 0.04) and peak values (P ≤ 0.05) were higher in EB-HF after the recovery drink. Achieving energy balance with a high-fat meal in a 'train-low' ('sleep-low') model did not enhance markers of skeletal muscle adaptation and impaired glycaemia in response to a recovery drink following training in the morning.",2020,mRNA expression of p53 increased after exercise (P = 0.005) and was higher in ED-LF at 3.5h compared to EB-HF (P = 0.027).,[],"['low carbohydrate availability (LCHO', ""sleep-low' protocol: on day 1 they cycled to deplete muscle glycogen while reaching a set energy expenditure"", 'Post-exercise, low carbohydrate, protein-matched meals completely (EB-HF, 30\xa0kcal/kg FFM']","['mRNA expression of p53 increased after exercise', 'peak values', 'skeletal muscle adaptation and impairs glycemic response', 'Plasma glucose and insulin AUC (P']",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0267765,mRNA expression of p53 increased after exercise (P = 0.005) and was higher in ED-LF at 3.5h compared to EB-HF (P = 0.027).,"[{'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Areta', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Iraki', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Owens', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Joanisse', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Philp', 'Affiliation': 'Mitochondrial Metabolism and Ageing Laboratory, Diabetes and Metabolism Division, Garvan Institute of Medical Research, Darlinghurst, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morton', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Hallén', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Experimental physiology,['10.1113/EP088795']
1762,32826001,The effect of osteopathic manual therapy with breathing retraining on cardiac autonomic measures and breathing symptoms scores: A randomised wait-list controlled trial.,"BACKGROUND


Breathing retraining and manual therapy (MT), delivered independently or together, influence autonomic activity, and improve symptoms in patients with chronic conditions. This study evaluated the effects of breathing retraining and osteopathic MT on cardiac autonomic measures and breathing symptoms during spontaneous breathing in healthy active adults.
METHODS


Participants (n = 18) received breathing retraining and four, weekly manual therapy sessions, randomised to start immediately, or after 6-week delay. Heart-rate (HR) variability was assessed as a 7-day average of waking 6-min electrocardiograms, using time (logarithm of root-mean-square of successive differences; LnRMSSD) and frequency domain (logarithm of high-frequency; LnHF) measures. Recordings were taken before, one week following intervention or delay, and then following the later intervention for those with delayed starts. Changes were compared between those who received and had yet to receive the intervention, and before and after treatment for the whole cohort.
RESULTS


Following the intervention, HR-variability measures increased 4% overall (Effect Sizes: 1.0-1.1) for the whole cohort. Between-group analyses showed that the immediate-start group increased more than the delayed start group: LnRMSSD 0.27 (0.02-0.52; 95%CI) ln.ms, and LnHF 0.41 (-0.01-0.84) ln.ms 2  for immediate start; compared with LnRMSSD -0.09 (-0.29-0.11) ln.ms, and LnHF -0.19 (-0.59-0.22) ln.ms 2  (P = 0.02-0.03 for interaction) for delayed start. Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
CONCLUSION


A 6-week osteopathic treatment consisting of breathing retraining and MT is beneficial in raising HR-variability compared to no treatment, and may induce favourable (parasympathetic over sympathetic) autonomic modulation.
TRIAL REGISTRATION


ACTRN12614001119684.",2020,"Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
","['Participants (n\xa0=\xa018) received', 'patients with chronic conditions', 'healthy active adults']","['breathing retraining and osteopathic MT', 'breathing retraining and four, weekly manual therapy sessions', 'osteopathic manual therapy with breathing retraining', 'breathing retraining', 'Breathing retraining and manual therapy (MT']","['Resting HR', 'cardiac autonomic measures and breathing symptoms scores', 'HR-variability measures', '7-day average of waking 6-min electrocardiograms, using time (logarithm of root-mean-square of successive differences; LnRMSSD) and frequency domain (logarithm of high-frequency; LnHF) measures', 'cardiac autonomic measures and breathing symptoms', 'Heart-rate (HR) variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424805', 'cui_str': 'Breath symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0562482,"Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
","[{'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Benjamin', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Moran', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Plews', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Kilding', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Barnett', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Verhoeff', 'Affiliation': 'Sport, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Bacon', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand; School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. Electronic address: c.bacon@auckland.ac.nz.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.014']
1763,32826003,The immediate effect of whole body vibration training on the electromyographic activity of contralateral hand muscles; a randomized controlled trial.,"Whole Body Vibration (WBV) has been used as a useful adjunct to improve the neuromuscular function of the upper limb. Cross-transfer of strength plays an important role in rehabilitation of unilateral injuries. The present research intended to evaluate the acute effect of low frequency WBV training on cross-transfer of electromyographic activity and hand muscles strength when the measurement was performed on the contralateral limb. This was a randomized crossover trial conducted in a clinical biomechanics laboratory. Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest. The participants were randomly assigned in two groups as follows: 1) active WBV/sham WBV; 2) sham WBV/active WBV. The participants were asked to stand on the vibrating plate and pull its belt in a vibrating mode using their dominant hand. Then, after a two-week rest, they performed the same task in the vibrating mode (35 Hz). Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb were measured before and after exercise in both phases. No significant change was observed in the electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb (P > 0.05). WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb. Further studies would help to explore these results for several sessions of WBV on cross-transfer of training.",2020,WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb.,['Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest'],"['low frequency WBV training', 'active WBV/sham WBV; 2) sham WBV/active WBV', 'whole body vibration training', 'Whole Body Vibration (WBV']","['electromyographic activity of contralateral hand muscles', 'Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb', ""electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb"", 'electromyographic activity and hand muscles strength']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0581668', 'cui_str': 'Muscle structure of hand'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0224261', 'cui_str': 'Structure of flexor digitorum profundus muscle of hand'}, {'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0224272', 'cui_str': 'Extensor carpi ulnaris muscle structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0060663', 'cui_str': 'formycin diphosphate'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",28.0,0.0166128,WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb.,"[{'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Taghizadeh Delkhoush', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: Rasool.Bagheri@Semums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Mashhadi Hashemi', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Fatemy', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Hedayati', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.027']
1764,32826008,"Effect of adding stretching to standardized procedures on cervical range of motion, pain, and disability in patients with non-specific mechanical neck pain: A randomized clinical trial.","OBJECTIVE


to investigate the benefit of adding stretching exercises to cervical joint mobilization and active rotation exercises for patients with non-specific mechanical neck pain.
METHODS


Thirty-eight subjects with non-specific mechanical neck pain were randomly assigned to a standard procedure group (passive cervical mobilization and active cervical rotation range of motion exercise) or a combined procedure (passive cervical mobilization, active cervical rotation range of motion exercises, and stretching procedures). Mixed factorial analysis of variance was used to compare changes between groups over time in active cervical range of motion, Numeric Pain Rating Scale, Neck Disability Index, Global Rating of Change, and Pressure Pain Threshold.
RESULTS


There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001). There was a significant group by time interaction in mean active range of motion during extension (p = 0.01), right rotation (p = 0.004), right and left lateral flexion (p = 0.05, and p = 0.02 respectively). However, there was no significant group by time interaction in mean active range of motion during flexion, left rotation, pain intensity (p = 0.09), right and left pressure pain threshold (p = 0.30, 0.47, respectively), and disability (p = 0.07).
CONCLUSIONS


Both study groups improved significantly in all subjective and objective outcome measures. However, data from this study suggest that adding stretching to the standard procedures may be more effective than the standard procedure alone at improving cervical extension, right rotation, and lateral flexion active range of motion, but not pain and disability.",2020,"There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001).","['Thirty-eight subjects with non-specific mechanical neck pain', 'patients with non-specific mechanical neck pain']","['stretching exercises to cervical joint mobilization and active rotation exercises', 'adding stretching to standardized procedures', 'standard procedure group (passive cervical mobilization and active cervical rotation range of motion exercise) or a combined procedure (passive cervical mobilization, active cervical rotation range of motion exercises, and stretching procedures']","['time interaction in mean active range of motion during extension', 'right and left pressure pain threshold', 'disability', 'right rotation', 'active cervical range of motion, Numeric Pain Rating Scale, Neck Disability Index, Global Rating of Change, and Pressure Pain Threshold', 'time interaction in mean active range of motion during flexion, left rotation, pain intensity', 'mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time', 'cervical range of motion, pain, and disability', 'cervical extension, right rotation, and lateral flexion active range of motion', 'right and left lateral flexion']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}]",38.0,0.127046,"There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001).","[{'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alfawaz', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Department of Physical Therapy, College of Medical Rehabilitation Sciences, King Abdulaziz University, Saudi Arabia.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Lohman', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Alameri', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Brockton Physical Therapy, Riverside, CA, USA.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Jaber', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Department of Physical Therapy, School of Rehabilitative Sciences, University of St. Augustine for Health Sciences, Austin, TX, USA. Electronic address: Hjaber@llu.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.020']
1765,32826010,Short-term effect of muscle energy technique and mechanical diagnosis and therapy in sacroiliac joint dysfunction: A pilot randomized clinical trial.,"INTRODUCTION


Sacroiliac joint dysfunction (SIJD) is a prominent source of pain in low back pain (LBP) patients. Tenderness inferior to the posterior superior iliac spine (PSIS) is an important sign presented in SIJD. Techniques including muscle energy technique (MET) and mechanical diagnosis and therapy (MDT) have shown benefits in SIJD. However, the effects of these treatments on tenderness and pain around the PSIS are yet to be determined.
AIM


Compare and examine the preliminary short-term effect of MET and MDT on tenderness and pain around the PSIS in SIJD.
METHODS


Twenty patients, aged between 20 and 65 years and diagnosed with unilateral, sub-acute, or chronic SIJD, were screened for the inclusion criteria and were randomly allocated to the MET or the MDT group. Both the groups received treatment for four sessions over one week. Pain pressure threshold (PPT) and visual analogue scale (VAS) were determined by a blinded assessor on pre- and post-treatment basis.
RESULTS


Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups. No drop-outs and no adverse events were reported.
CONCLUSION


The findings of the study suggest that both interventions may be equally effective in reducing symptoms around the PSIS. However, due to the small sample size, the results need to be interpreted cautiously. Future studies on larger sample size and long-term follow up are warranted.",2020,"Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups.","['Twenty patients, aged between 20 and 65 years and diagnosed with unilateral, sub-acute, or chronic SIJD, were screened for the inclusion criteria', 'low back pain (LBP) patients', 'sacroiliac joint dysfunction']","['MET and MDT', 'muscle energy technique (MET) and mechanical diagnosis and therapy (MDT', 'muscle energy technique and mechanical diagnosis and therapy', 'posterior superior iliac spine (PSIS']","['tenderness and pain', 'drop-outs and no adverse events', 'Pain pressure threshold (PPT) and visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0223646', 'cui_str': 'Structure of posterior superior iliac spine'}]","[{'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0363968,"Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups.","[{'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India. Electronic address: saumyasri2000@nitte.edu.in.'}, {'ForeName': 'Dhanesh', 'Initials': 'D', 'LastName': 'Kumar K U', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India.'}, {'ForeName': 'Harramb', 'Initials': 'H', 'LastName': 'Mittal', 'Affiliation': 'Department of Trauma and Orthopedics, Kanachur Institute of Medical Sciences, Mangalore, Karnataka, India. Electronic address: dr_harramb@yahoo.co.in.'}, {'ForeName': 'Snehil', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Department of Medical Rehabilitation Sciences, King Khalid University, Saudi Arabia.'}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.017']
1766,32826188,How periarticular corticosteroid injections impact the integrity of arthroscopic rotator cuff repair.,"INTRODUCTION


Multimodal analgesic (MMA) injections combined with corticosteroids have recently been shown to be effective for managing pain after arthroscopic rotator cuff repair.
HYPOTHESIS


The goal of this study was to analyze the effects of corticosteroid injections on the integrity of tendon repairs using magnetic resonance imaging (MRI). The hypothesis was that MMA injections combined with corticosteroids have no deleterious effects on functional outcomes and tendon healing 1 year after surgical rotator cuff repair.
METHODS


This was a prospective, double-blind study of 50 patients undergoing arthroscopic rotator cuff repair who were randomized into two groups. The study group (n=25) received a periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone at the end of the procedure. The control group (n=25) received a placebo injection. The clinical outcomes were the pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST). The structural integrity of the operated tendons was analyzed on MRI at a mean follow-up of 15.1±1.3 months for the study group and 15.2±1.1 for the control group (p=0.848).
RESULTS


Pain on a visual analog scale was significantly reduced in both groups after the surgery. Nevertheless, there was no significant difference between groups at the final follow-up visit (p=0.803). Compared to the preoperative values, the CMS, ASES and SST significantly improved in both groups after surgery but were not significantly different between groups at the final assessment (p=0.801, 0.869 and 0.769, respectively). MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107). There were no infections in the study group as of the final assessment. Advanced age (p=0.049), diabetes (p<0.01) and posterior extension of the tear (p=0.039) negatively impact healing. Corticosteroid injection did not negatively impact healing (p=0.197).
CONCLUSION


This study shows that MMA injection combined with corticosteroids does not alter the tendon healing, clinical outcomes, or functional outcomes 1 year after arthroscopic rotator cuff repair. It remains a safe and effective analgesia method during rotator cuff repair surgery.
LEVEL OF EVIDENCE


II, low-powered placebo-controlled, randomized study.",2020,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"['50 patients undergoing arthroscopic rotator cuff repair', 'arthroscopic rotator cuff repair']","['periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone', 'Corticosteroid injection', 'MMA injections combined with corticosteroids', 'placebo injection', 'Multimodal analgesic (MMA) injections combined with corticosteroids', 'magnetic resonance imaging (MRI', 'corticosteroid injections', 'MMA injection combined with corticosteroids']","['CMS, ASES and SST', 'pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST', 'visual analog scale', 'supraspinatus tendon retears']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",50.0,0.151985,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Perdreau', 'Affiliation': ""Orthopedic and Trauma Surgery Department, Centre Hospitalier de l'Ardenne, 35, Avenue de Houffalize 35, 6800 Libramont-Chevigny, Belgium. Electronic address: perdreaua@hotmail.com.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duysens', 'Affiliation': 'Institut Européen de la main, Centre Hospitalier du Kirchberg, 9, Rue Edward Steichen, 2540 Luxembourg, Grand Duchy of Luxembourg, Luxembourg.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Joudet', 'Affiliation': 'Orthopedic Surgery Department, Clinique Chirurgicale du Libournais, 119, Rue de la Marne, 33500 Libourne, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.05.009']
1767,32826543,The Impact of Receiving a Family-Oriented Therapeutic Conversation Intervention Before and During Bereavement Among Family Cancer Caregivers: A Nonrandomized Trial.,"Effective communication is the foundation of quality care in palliative nursing. As frontline palliative home care providers, nurses could foster more effective bereavement coping skills through therapeutic conversations. The purpose of this study was to evaluate the impact of a nursing intervention offered to bereaved family cancer caregivers. This was a quasi-experimental design, with a posttest-only comparison of the intervention and control groups receiving usual care. Bereaved caregivers (n = 51) receiving services from a specialized palliative home care unit participated and completed measures of depression, anxiety, stress, and grief reactions 3, 5, and 6 months after their close relative had died.There was a significant decrease in anxiety symptoms in the intervention group compared with the control group across all 3 time points. Anxiety and stress symptoms also decreased over time in the 2 groups combined, but this decrease was not observed for depression. When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.Results demonstrate that providing bereaved family caregivers the opportunity to participate in a therapeutic conversation intervention might reduce distressing symptoms in early bereavement.",2020,"When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.","['Family Cancer Caregivers', 'bereaved family cancer caregivers', 'Bereaved caregivers (n = 51) receiving services from a specialized palliative home care unit participated and completed', 'palliative nursing']","['Receiving a Family-Oriented Therapeutic Conversation Intervention', 'control groups receiving usual care', 'nursing intervention']","['controlled grief responses', 'anxiety symptoms', 'Anxiety and stress symptoms', 'distressing symptoms', 'measures of depression, anxiety, stress, and grief reactions']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3816218', 'cui_str': 'Palliative Care Nursing'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",51.0,0.0187652,"When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.","[{'ForeName': 'Asta B', 'Initials': 'AB', 'LastName': 'Petursdottir', 'Affiliation': 'Asta B. Petursdottir, PhD, RN, School of Health Sciences, University of Iceland; Palliative Care Unit, Landspitali - The National University Hospital, Reykjavík, Iceland; and Faculty of Nursing, School of Health Sciences, Faculty of Nursing at the University of Iceland. Valgerdur Sigurdardottir, MD, PhD, Palliative Care Unit, Landspitali - The National University Hospital, Reykjavík, Iceland; and clinical lector, School of Health Sciences, University of Iceland, Iceland. Mary Kay Rayens, PhD, University of Kentucky, Lexington. Erla Kolbrun Svavarsdottir, PhD, RN, FAAN, is professor at the School of Health Sciences, Faculty of Nursing at the University of Iceland and the Head of Research and Development in Family Nursing at Landspitali the National University Hospital in Reykjavik, Iceland.'}, {'ForeName': 'Valgerdur', 'Initials': 'V', 'LastName': 'Sigurdardottir', 'Affiliation': ''}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': ''}, {'ForeName': 'Erla Kolbrun', 'Initials': 'EK', 'LastName': 'Svavarsdottir', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000679']
1768,32826624,"Double standards: why is pulse oximetry standard care, whereas tissue oximetry is not?","PURPOSE OF REVIEW


Why is pulse oximetry a standard monitor, whereas tissue oximeter is not? Is this a double-standard treatment?
RECENT FINDINGS


There appears to be a lack of enthusiasm for a continual investigation into whether the use of pulse oximetry leads to reduced morbidity and mortality in acute care although there is no robust evidence attesting to its outcome benefits. In contrast, research investigating the outcome effectiveness of tissue oximetry-guided care is consistently ongoing. A recent randomized controlled trial involving 800 patients who underwent laparoscopic hysterectomy found that, although muscular tissue oxygen saturation-guided care did not reduce the overall occurrence of postoperative nausea and vomiting for all patients, it did reduce the occurrence of these symptoms in patients who had a body mass index ≥25. It was also observed that muscular tissue oxygen saturation increases when blood pressure falls following the administration of nicardipine. These studies highlight the persistence of interest in understanding the value of tissue oximetry in patient care.
SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits. This difference may root in the difference in the physiology they monitor, the cost, the ease of use/interpretation/intervention and the relevance to patient safety and care quality. Pulse oxygen saturation represents a vital sign, whereas tissue oxygen saturation is likely a quality sign; however, further research endeavors are required to fully understand how to best use tissue oximetry.",2020,"SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits.","['800 patients who underwent', 'patients who had a body mass index ≥25']","['laparoscopic hysterectomy', 'tissue oximetry-guided care', 'muscular tissue oxygen saturation-guided care', 'nicardipine']","['blood pressure falls', 'overall occurrence of postoperative nausea and vomiting']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0439779', 'cui_str': 'BP fall'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",800.0,0.0313832,"SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits.","[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Jiangxi Cancer Hospital.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Lingzhong', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Current opinion in anaesthesiology,['10.1097/ACO.0000000000000910']
1769,32827193,Is antibiotics prescription needed in infants with topical corticosteroids treatment for moderate-to-severe atopic dermatitis?,"The cutaneous microbiota responses to skin health as well as atopic dermatitis. To reveal the microbiota effect in atopic dermatitis children under therapy with topical corticosteroids and antibiotics. 59 atopic dermatitis patients were randomized to two treatment groups (by corticosteroids or combination therapy) in Beijing Children's Hospital. The lesion microbial samples were collected for 16S rDNA sequencing and bioinformatics analysis. After treatment, 57 patients recovered significantly. Though topical antibiotics application blocked the restoration of commensal Streptococcus, no remarkable differences of cutaneous microbiota were identified between the two groups along the treatment. In subject 1081, who received the combination therapy, the Streptococcus and Pseudomonas as well as Chryseobacterium increased dramatically. On the contrary, the Staphylococcus aureus decreased sharply in subject 1107 with topical corticosteroids treatment Our preliminary study suggested the necessity to consider cutaneous microbiota profile when prescribing antibiotics.",2020,"Though topical antibiotics application blocked the restoration of commensal Streptococcus, no remarkable differences of cutaneous microbiota were identified between the two groups along the treatment.","['atopic dermatitis children', 'infants with topical corticosteroids treatment for moderate-to-severe atopic dermatitis', '59 atopic dermatitis patients']",['corticosteroids or combination therapy'],"['restoration of commensal Streptococcus', 'cutaneous microbiota']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",1107.0,0.0319207,"Though topical antibiotics application blocked the restoration of commensal Streptococcus, no remarkable differences of cutaneous microbiota were identified between the two groups along the treatment.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Computer Science, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wenkui', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Department of Microbial Research, WeHealthGene Institute, Shenzhen, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Yinhu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Computer Science, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Dongfang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Microbial Research, WeHealthGene Institute, Shenzhen, China.'}, {'ForeName': 'Yunzhu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Shuaicheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Computer Science, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yi-Wei', 'Initials': 'YW', 'LastName': 'Tang', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer, New York, New York, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}]",Dermatologic therapy,['10.1111/dth.14215']
1770,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis (RA). Eighty RA patients were randomized to tocilizumab (n = 40) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and glucocorticoids (GC) (n = 40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: (a)perfused boundary region (PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), (b)pulse wave velocity (PWV), (c)global LV longitudinal strain (GLS), (d)global work index (GWI) using speckle tracking echocardiography and e)C-reactive protein (CRP), malondialdehyde (MDA) and protein carbonyls (PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers (P < 0.05). Compared with baseline, tocilizumab reduced PBR(2.14 ± 0.2 versus 1.97 ± 0.2 μm; P < 0.05) while no significant differences were observed post-csDMARDs + GC(P > 0.05). Compared with csDMARDs + GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P < 0.05). The percent improvement of glycocalyx thickness (PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P < 0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs + GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: url: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
1771,32822827,A community-based asthma program: Study design and methods of RVA Breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
1772,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
1773,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and Design of a Cluster-Randomized Trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi. FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0 mmHg difference in systolic BP at a 0.05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the US.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
1774,32827501,Intranasal vasopressin expedites dishonesty in women.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in men and women. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, women receiving intranasal AVP lied more than women receiving intranasal placebo and men receiving intranasal AVP. The dishonest behavior of women treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in women, contingent on the motivation of dishonesty. Our findings provide insight into gender-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
1775,32827517,"Ropinirole, a dopamine agonist with high D 3  affinity, reduces proactive inhibition: A double-blind, placebo-controlled study in healthy adults.","Response inhibition describes the cognitive processes mediating the suppression of unwanted actions. A network involving the basal ganglia mediates two forms of response inhibition: reactive and proactive inhibition. Reactive inhibition serves to abruptly stop motor activity, whereas proactive inhibition is goal-orientated and results in slowing of motor activity in anticipation of stopping. Due to its impairment in several psychiatric disorders, the neurochemistry of response inhibition has become of recent interest. Dopamine has been posed as a candidate mediator of response inhibition due to its role in functioning of the basal ganglia and the observation that patients with Parkinson's disease on dopamine agonists develop impulse control disorders. Although the effects of dopamine on reactive inhibition have been studied, substantial literature on the role of dopamine on proactive inhibition is lacking. To fill this gap, we devised a double-blind, placebo-controlled study of 1 mg ropinirole (a dopamine agonist) on response inhibition in healthy volunteers. We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo. To investigate how ropinirole mediated this effect on proactive inhibition, we used hierarchical drift-diffusion modelling. We found that ropinirole impaired the ability to raise the decision threshold when proactive inhibition was called upon. Our results provide novel evidence that an acute dose of ropinirole selectively reduces proactive inhibition in healthy participants. These results may help explain how ropinirole induces impulse control disorders in susceptible patients with Parkinson's disease.",2020,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[""susceptible patients with Parkinson's disease"", 'healthy volunteers', ""patients with Parkinson's disease on dopamine agonists develop impulse control disorders"", 'healthy adults', 'healthy participants']","['Dopamine', 'Ropinirole', 'ropinirole', 'ropinirole (a dopamine agonist', 'dopamine', 'placebo']","['reactive inhibition', 'proactive inhibition']","[{'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0021122', 'cui_str': 'Impulse control disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034750', 'cui_str': 'Inhibition, Reactive'}, {'cui': 'C0033199', 'cui_str': 'Inhibition, Proactive'}]",,0.116831,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Rawji', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK. Electronic address: vishal.rawji.11@ucl.ac.uk.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108278']
1776,32846768,Study on the clinical assessment of integrated rehabilitation of Traditional Chinese Medicine and western medication for acute myocardial infarction.,"OBJECTIVE


This trial aims to evaluate the efficacy and safety of the Baduanjin exercise in patients with acute myocardial infarction (AMI).
METHODS


A single-center, open, randomized controlled clinical trial will be conducted to evaluate the effectiveness of the Baduanjin exercise on the rehabilitation of AMI patients. It plans to enroll 64 patients. Patients will be divided evenly into 2 groups using a random number table method. There will be 32 cases in each group. Patients in the experimental group will be treated with standardized drug therapy combined with Baduanjin exercise, while patients in the control group will be treated with standardized drug therapy combined with routine exercise. The primary outcome is the peak oxygen consumption (Peak VO2) during cardiopulmonary exercise test (CPET). The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc. DISCUSSION:: This study will be the first to evaluate the effect of the Baduanjin exercise on the Peak VO2 in patients with AMI.
STUDY REGISTRATION


This study has been registered on the Chinese Clinical Trial Registry (No: ChiCTR1800016209, protocol version 1.2).",2020,"The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc.","['acute myocardial infarction', 'patients with acute myocardial infarction (AMI', 'patients with AMI', 'AMI patients']","['standardized drug therapy combined with Baduanjin exercise', 'Traditional Chinese Medicine and western medication', 'standardized drug therapy combined with routine exercise', 'Baduanjin exercise']","['efficacy and safety', 'peak oxygen consumption (Peak VO2) during cardiopulmonary exercise test (CPET', 'CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc']","[{'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0686368,"The secondary outcomes include CPET, echocardiography, Seattle angina pectoris scale, hospital depression and anxiety scale, Pittsburgh Sleep Quality Index scale, scores of 4 examinations, and diagnostic methods of traditional Chinese medicine and composite endpoint events, etc.","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Lishuo', 'Initials': 'L', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Chenyu', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Lindan', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Mao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021592']
1777,32846775,The effect of stem cell therapy and comprehensive physical therapy in motor and non-motor symptoms in patients with multiple sclerosis: A comparative study.,"INTRODUCTION


People with multiple sclerosis (PwMS) experience a wide range of disabilities which negatively impact their quality of life (QOL). Several interventions have been used in PwMS such as medication, physical therapy exercises and stem cell therapy to improve their QOL. However, there is a limited evidence on the benefits of combining interventions. The purpose of this study is to explore the effect of combining physical therapy exercises (PTE) and Wharton Jelly mesenchymal stem cell (WJ-MSCs) injections on motor and non-motor symptoms versus each intervention alone in PwMS.
METHODS


Sixty PwMS will be allocated to either PTE, WJ-MSCs, or a combined group, followed up for 12 months and examined using a comprehensive battery of measures. Participants in the PTE group will receive 2 sessions per week of a supervised exercise program for 6 months followed by a home exercise program for another 6 months. The WJ-MSCs group will receive 3 WJ-MSCs injections in the first 6 months then they will be encouraged to follow an active life style. The third group will receive both interventions.
DISCUSSION


This study will aid in a better understanding of the combined effect of physical therapy and mesenchymal stem cell therapy. The results from this proposed study may reduce disability, improve QOL in PwMS, and consequently, reduce the cost associated with the life-time care of these individuals worldwide.
TRIAL REGISTRATION NUMBER


NCT03326505.",2020,"The results from this proposed study may reduce disability, improve QOL in PwMS, and consequently, reduce the cost associated with the life-time care of these individuals worldwide.
","['PwMS', 'Sixty PwMS', 'patients with multiple sclerosis']","['physical therapy and mesenchymal stem cell therapy', 'physical therapy exercises (PTE) and Wharton Jelly mesenchymal stem cell (WJ-MSCs) injections', 'stem cell therapy and comprehensive physical therapy', 'supervised exercise program for 6 months followed by a home exercise program', 'PTE, WJ-MSCs']",['quality of life (QOL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0230987', 'cui_str': ""Structure of Wharton's jelly""}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0872278', 'cui_str': 'Stem cell therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0266785,"The results from this proposed study may reduce disability, improve QOL in PwMS, and consequently, reduce the cost associated with the life-time care of these individuals worldwide.
","[{'ForeName': 'Alia A', 'Initials': 'AA', 'LastName': 'Alghwiri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Jamali', 'Affiliation': 'Cell Therapy Center, the University of Jordan, Amman.'}, {'ForeName': 'Mayis', 'Initials': 'M', 'LastName': 'Aldughmi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Khalil', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid.'}, {'ForeName': 'Alham', 'Initials': 'A', 'LastName': 'Al-Sharman', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Alhattab', 'Affiliation': 'Laboratory for Nanomedicine, Division of Biological & Environmental Science & Engineering (BESE), King Abdullah University of Science and Technology (KAUST), Thuwal, 23955-6900, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Radaideh', 'Affiliation': 'Department of Medical Imaging, Faculty of Applied Medical Sciences, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Abdalla', 'Initials': 'A', 'LastName': 'Awidi', 'Affiliation': 'Cell Therapy Center, the University of Jordan, Amman.'}]",Medicine,['10.1097/MD.0000000000021646']
1778,32846782,The efficacy and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty: A protocol of randomized controlled trial.,"BACKGROUND


Concerns exist regarding the analgesia effect and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the dexamethasone administration, and investigate its clinical applicability. We thus further designed a randomized controlled study to assess the different dose of dexamethasone on postoperative pain and complications in patients undergoing unicompartmental knee arthroplasty.
METHODS


This randomized, prospective, controlled study was carried out between January 2018 and August 2019. It was approved by the institutional review board in our hospital (HBRM2020013). A total of 80 patients were randomly assigned to each group: the study group (n = 40) and the control group (n = 40). All surgical procedures were performed by a similar orthopedic surgeon. In the study group, patients received intravenously 20 mg dexamethasone (4 mL, Tianjin Kingyork group Co., Ltd., China) just after the anesthesia, and repeated at 24 hours after the surgery. Patients in the control group received intravenously 10 mg dexamethasone solution (2 mL) just after the anesthesia, and repeated at 24 hours after the surgery. CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.
CONCLUSION


We hypothesized that patients receiving multiple doses of dexamethasone was associated with better outcomes compared with patients receiving single dose of dexamethasone.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5770).",2020,"CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.
","['80 patients', 'January 2018 and August 2019', 'unicompartmental knee arthroplasty', 'patients undergoing unicompartmental knee arthroplasty']","['dexamethasone', 'intravenously 10\u200amg dexamethasone solution']","['efficacy and safety', 'postoperative pain and complications', 'CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520905', 'cui_str': 'Postoperative vomiting'}]",80.0,0.170952,"CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively.
","[{'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': ""Department of Anesthesia, Hanchuan People's Hospital.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesia, Hanchuan People's Hospital.""}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, Renmin Hospital of Wuhan University/Hubei General Hospital, Hubei, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesia, Hanchuan People's Hospital.""}]",Medicine,['10.1097/MD.0000000000021671']
1779,32721580,Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.,"Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection. 1 , 2  In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19. 3  In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported. 4 , 5  In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0). 6  Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.",2020,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"['adults admitted to hospital with severe COVID-19 (n\xa0= 237', 'healthy volunteers and patients with COVID-19', 'recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0', 'patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection']",['placebo'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0311468', 'cui_str': 'Increased bilirubin level'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.110012,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montastruc', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France. Electronic address: francois.montastruc@univ-tlse3.fr.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Thuriot', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Durrieu', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.050']
1780,32827645,Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low- to Middle-Income Countries: A Phase II Non-Inferiority Randomized Controlled Study.,"BACKGROUND


Minimal access surgery [MAS] is not available to most people in the rural areas of Low Middle-Income Countries [LMIC]. This leads to an increase in the morbidity and the economic loss to the poor and the marginalized. The Gasless laparoscopic surgeries [GAL] are possible in rural areas as they could be carried out under spinal-anaesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anaesthesia. The current study compares GAL with conventional Laparoscopic surgeries [COL] for general surgical procedures METHODS: A single-centre, non-blinded randomized control trial [RCT] was conducted to evaluate non - inferiority of GAL versus COL at a teaching hospital in New Delhi. Patients were allocated into two groups and underwent MAS (Cholecystectomies and appendectomies). The procedure was carried out by two surgeons by randomly choosing between GAL and COL. The data was collected by postgraduates and analyzed by a biostatistician.
RESULTS


100 patients who met the inclusion criteria were allocated into two groups. No significant difference was observed in the mean operating time between GAL group (52.9 min) vs COL group (55 minutes) [p=0.3]. The intraoperative vital signs were better in the GAL group [p < 0.05]. The postoperative pain score was slightly higher in the GAL group [p = 0.01]; however, it did not require additional analgesics.
CONCLUSIONS


No significant differences were found between the two groups. GAL can be classed as non-inferior compared to COL and has the potential to be adopted in low resource settings.",2020,The intraoperative vital signs were better in the GAL group [p < 0.05].,['100 patients who met the inclusion criteria'],"['GAL versus COL', 'MAS (Cholecystectomies and appendectomies', 'Gasless Laparoscopy', 'RCT', 'Gasless laparoscopic surgeries [GAL', 'Minimal access surgery [MAS', 'GAL', 'conventional Laparoscopic surgeries [COL']","['postoperative pain score', 'mean operating time', 'intraoperative vital signs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",100.0,0.035368,The intraoperative vital signs were better in the GAL group [p < 0.05].,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi. Electronic address: anurag.alok@gmail.com.'}, {'ForeName': 'Lovenish', 'Initials': 'L', 'LastName': 'Bains', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}, {'ForeName': 'Gnanaraj', 'Initials': 'G', 'LastName': 'Jesudin', 'Affiliation': 'Project GILLS Association of Rural Surgeons of India.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Aruparayil', 'Affiliation': ""Leeds Institute of Medical Research at St. James's, University of Leeds, UK.""}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shashi', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.07.783']
1781,32827709,Acute effect of inspiratory resistive loading on sprint interval exercise performance in team-sport athletes.,"This study examined acute effects of inspiratory resistive loading (IRL) during rest intervals on sprint interval exercise (SIE) performance. In a randomized crossover design, nine collegiate basketball players performed IRL (15 cmH 2 O) or passive recovery (CON) at 5-min rest intervals during and immediately after 6 sets of a 30-s SIE test. Performance, muscular oxygenation of vastus lateralis, blood lactate and pH were measured at each condition. Blood lactate at 5-min (-20.5 %) and 20-min (-21.3 %) after SIE were significantly lower in IRL than in CON. The pH at 5-min after SIE was significantly higher in IRL than in CON (+0.8 %, p <  0.05). However, the total work in IRL was significantly lower than in CON (-2.7 %, p <  0.05). Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5 %, p <  0.05). The IRL could attenuate exercise-induced metabolic acidosis; however, the decreased blood flow at rest intervals might increase the physical challenge in SIE.",2020,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).",['team-sport athletes'],"['inspiratory resistive loading (IRL', 'CON', 'inspiratory resistive loading', 'IRL (15\u2009cmH 2 O) or passive recovery (CON']","['sprint interval exercise performance', 'Blood lactate', 'IRL', 'sprint interval exercise (SIE) performance', 'total hemoglobin at rest intervals in IRL', 'blood flow', 'Performance, muscular oxygenation of vastus lateralis, blood lactate and pH', 'total work in IRL']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",,0.0174742,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).","[{'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Cheng', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan; Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan. Electronic address: andescheng@ntnu.edu.tw.'}, {'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Graduate Institute of Sports Training, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Physical Education Office, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103531']
1782,32832978,"Fremanezumab: a disease-specific option for the preventive treatment of migraine, including difficult-to-treat migraine.","Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that targets calcitonin gene-related peptide (CGRP), a key neuropeptide involved in the pathophysiology of migraine. Fremanezumab is approved for quarterly and monthly subcutaneous dosing for the preventive treatment of migraine in adults. The phase 3 clinical development program for fremanezumab aimed to evaluate the efficacy of this preventive treatment across different patient populations, including those with difficult-to-treat migraine. Two pivotal 12-week, phase 3, placebo-controlled studies investigated quarterly and monthly dosing of fremanezumab in participants with chronic migraine (HALO CM) and episodic migraine (HALO EM). The efficacy of fremanezumab was further explored in individuals with difficult-to-treat chronic or episodic migraine in the 12-week FOCUS study, which enrolled participants who had previously experienced an inadequate response to 2-4 pharmacological classes of migraine preventive medications. The long-term efficacy of fremanezumab was assessed in a 12-month long-term study (HALO LTS), which enrolled participants completing the 12-week HALO studies and new participants. Across these studies, treatment with fremanezumab dosed quarterly or monthly provided significant reductions in the frequency of migraine days, headache days of at least moderate severity, and migraine- and headache-related disability compared with placebo. Sustained improvements were seen with long-term fremanezumab treatment. Subgroup analyses of participants with difficult-to-treat migraine (those with comorbid depression, overuse of acute headache medications, and concomitant use of other migraine preventive medications) demonstrated the effectiveness of quarterly or monthly fremanezumab in these populations. Ongoing studies are further exploring the potential benefits of fremanezumab in difficult-to-treat migraine and other headache and pain disorders.",2020,"Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that targets calcitonin gene-related peptide (CGRP), a key neuropeptide involved in the pathophysiology of migraine.","['participants with difficult-to-treat migraine (those with comorbid depression, overuse of acute headache medications, and concomitant use of other migraine preventive medications', 'migraine in adults', 'individuals with difficult-to-treat chronic or episodic migraine in the 12-week FOCUS study, which enrolled participants who had previously experienced an inadequate response to 2-4 pharmacological classes of migraine preventive medications', 'participants with chronic migraine (HALO CM) and episodic migraine (HALO EM', 'enrolled participants completing the 12-week HALO studies and new participants']","['Fremanezumab', 'placebo', 'fremanezumab']","['frequency of migraine days, headache days of at least moderate severity, and migraine- and headache-related disability']","[{'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0477373', 'cui_str': 'Other migraine'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0209867,"Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that targets calcitonin gene-related peptide (CGRP), a key neuropeptide involved in the pathophysiology of migraine.","[{'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Departments of Neurology and Neurotherapeutics and Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, U.S.A.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, U.S.A.'}]",Emerging topics in life sciences,['10.1042/ETLS20200018']
1783,32828187,"The Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised trials in Mozambique, Pakistan, and India: an individual participant-level meta-analysis.","BACKGROUND


To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries.
METHODS


In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014-17. Consenting pregnant women, aged 12-49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564.
FINDINGS


Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22-30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90-1·51; p=0·24). No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
INTERPRETATION


The CLIP intervention did not reduce adverse pregnancy outcomes. Future community-level interventions should expand the community health worker workforce, assess general (rather than condition-specific) messaging, and include health system strengthening.
FUNDING


University of British Columbia, a grantee of the Bill & Melinda Gates Foundation.",2020,"No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
","['6990 group and 16\u2008691 home-based community engagement sessions and 138\u2008347 community health worker-led visits to 20\u2008819 (57·8%) of 36\u2008008 women (of whom 11\u2008095', 'for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia', '1255', '44 clusters (69\u2008330 pregnant women', 'consenting participants who were followed up with completed pregnancies at trial end', '6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral', 'Median maternal age of included women was 26 years (IQR 22-30', 'women with pregnancy hypertension in three low-income countries', 'Consenting pregnant women, aged 12-49 years, were recruited in their homes']","['intramuscular magnesium sulfate', 'community-level interventions targeting', 'community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension', 'magnesium sulfate', 'CLIP intervention', 'methyldopa']","['composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby', 'adverse pregnancy outcomes', 'adverse effects', 'Blood pressure and dipstick proteinuria', 'control clusters', 'severe hypertension', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565599', 'cui_str': 'Maternal hypertension'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019982', 'cui_str': 'Referral to hospital'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441090', 'cui_str': 'Dipstick'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69330.0,0.274918,"No intervention-related serious adverse events occurred, and few adverse effects occurred after in-community treatment with methyldopa (one [2%] of 51; India only) and none occurred after in-community treatment with magnesium sulfate or during transport to facility.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada. Electronic address: pvd@kcl.ac.uk.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, Toronto, ON, Canada; Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mrutyunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': 'KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': 'KLE Academy of Higher Education and Research, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, Hanagal Shree Kumareshwar Hospital and Research Centre, Bagalkote, Karnataka, India.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça, Manhiça, Mozambique; Department of Physiological Sciences, Clinical Pharmacology, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça, Manhiça, Mozambique.'}, {'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Physiological Sciences, Clinical Pharmacology, Faculdade de Medicina, Universidade Eduardo Mondlane, Maputo, Mozambique.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': ""Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Obstetrics and Gynaecology, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31128-4']
1784,32828663,Harnessing Augmented Reality and CT to Teach First-Year Medical Students Head and Neck Anatomy.,"RATIONALE AND OBJECTIVES


Three-dimensional (3D) visualization has been shown to benefit new generations of medical students and physicians-in-training in a variety of contexts. However, there is limited research directly comparing student performance after using 3D tools to those using two-dimensional (2D) screens.
MATERIALS AND METHODS


A CT was performed on a donated cadaver and a 3D CT hologram was created. A total of 30 first-year medical students were randomly assigned into two groups to review head and neck anatomy in a teaching session that incorporated CT. The first group used an augmented reality headset, while the second group used a laptop screen. The students were administered a five-question anatomy test before and after the session. Two-tailed t-tests were used for statistical comparison of pretest and posttest performance within and between groups. A feedback survey was distributed for qualitative data.
RESULTS


Pretest vs. posttest comparison of average percentage of questions answered correctly demonstrated both groups showing significant in-group improvement (p < 0.05), from 59% to 95% in the augmented reality group, and from 57% to 80% in the screen group. Between-group analysis indicated that posttest performance was significantly better in the augmented reality group (p = 0.022, effect size = 0.73).
CONCLUSION


Immersive 3D visualization has the potential to improve short-term anatomic recall in the head and neck compared to traditional 2D screen-based review, as well as engage millennial learners to learn better in anatomy laboratory. Our findings may reflect additional benefit gained from the stereoscopic depth cues present in augmented reality-based visualization.",2020,"Immersive 3D visualization has the potential to improve short-term anatomic recall in the head and neck compared to traditional 2D screen-based review, as well as engage millennial learners to learn better in anatomy laboratory.",['A total of 30 first-year medical students'],"['augmented reality headset, while the second group used a laptop screen', 'Harnessing Augmented Reality and CT', 'teaching session that incorporated CT']",['posttest performance'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3873748', 'cui_str': 'Harness'}, {'cui': 'C0039401', 'cui_str': 'Education'}]",[],,0.0188048,"Immersive 3D visualization has the potential to improve short-term anatomic recall in the head and neck compared to traditional 2D screen-based review, as well as engage millennial learners to learn better in anatomy laboratory.","[{'ForeName': 'Joanna K', 'Initials': 'JK', 'LastName': 'Weeks', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA.'}, {'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Pakpoor', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA.'}, {'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'Robinson', 'Affiliation': 'Department of Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Neal A', 'Initials': 'NA', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Prouty', 'Affiliation': 'Department of Cell and Developmental Biology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Arun C', 'Initials': 'AC', 'LastName': 'Nachiappan', 'Affiliation': 'Department of Radiology, University of Pennsylvania, 3400 Spruce Street, 1 Silverstein, Suite 130, Philadelphia, PA. Electronic address: arun.nachiappan@pennmedicine.upenn.edu.'}]",Academic radiology,['10.1016/j.acra.2020.07.008']
1785,32828927,"Virtual training leads to physical, cognitive and neural benefits in healthy adults.","Physical activity, such as high-intensity intermittent aerobic exercise (HIE), can improve executive functions. Although performing strength or aerobic training might be problematic or not feasible for someone. An experimental situation where there is no actual movement, but the body shows physiological reactions, is during the illusion through immersive virtual reality (IVR). We aimed to demonstrate whether a virtual HIE-based intervention (vHIE) performed exclusively by the own virtual body has physical, cognitive, and neural benefits on the real body. 45 healthy young adults (cross-over design) experienced HIE training in IVR (i.e., the virtual body performed eight sets of 30 s of running followed by 30 s of slow walking, while the subject is completely still) in two random-ordered conditions (administered in two sessions one week apart): the virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP). During the vHIE, we recorded the heart rate and subjective questionnaires to confirm the effectiveness of the illusion; before and after vHIE, we measured cortical hemodynamic changes in the participants' left dorsolateral prefrontal cortex (lDLPFC) using the fNIRS device during the Stroop task to test our main hypothesis. Preliminary, we confirmed that the illusion was effective: during the vHIE in 1PP, subjects' heart rate increased coherently with the virtual movements, and they reported subjective feelings of ownership and agency. Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently. Clinically, these results might be exploited to train cognition and body simultaneously. Theoretically, we proved that the sense of body ownership and agency can affect other parameters, even in the absence of actual movements.",2020,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","['healthy adults', '45 healthy young adults']","['strength or aerobic training', 'virtual HIE-based intervention (vHIE', 'Virtual training', 'Physical activity, such as high-intensity intermittent aerobic exercise (HIE', 'virtual body is displayed in first-person perspective (1PP) or third-person perspective (3PP', 'HIE training']","['heart rate and subjective questionnaires', 'lDLPFC activity', 'heart rate']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",45.0,0.0142803,"Primarily, subjects were faster in executing the Stroop task after the vHIE in 1PP; also, the lDLPFC activity increased coherently.","[{'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Burin', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan. Electronic address: burin.dalila.c3@tohoku.ac.jp.'}, {'ForeName': 'Yingxu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Noriki', 'Initials': 'N', 'LastName': 'Yamaya', 'Affiliation': 'Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging International Research Center (SAIRC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan; Institute of Development, Aging and Cancer (IDAC), Tohoku University, 4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117297']
1786,32829060,The role of endogenous Antisecretory Factor (AF) in the treatment of Ménière's Disease: A two-year follow-up study. Preliminary results.,"PURPOSE


To evaluate the effects of increased endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC) in a sample of patients with defined unilateral Meniere's disease (MD), compared to the results of a treatment protocol of intravenous glycerol and dexamethasone.
MATERIALS AND METHODS


Twenty-six patients with unilateral MD were divided in 2 groups and treated with SPC and with intravenous glycerol and dexamethasone for 24 months. Audio-vestibular evaluation was performed before (T0) and every six months. The number of vertigo spells were evaluated before and after therapy and the Efficacy Index (EI) was calculated. Questionnaires for hearing loss, tinnitus and quality of life were administered.
RESULTS


EI decreased in the SPC group after 18 (T18) (p = .0017) and 24 (T24) months of therapy (p = .0111). There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131). No significant differences were found between the two groups at T0 (p = .4723), while a significant difference was found at T24 (p = .0027). Quality of life showed a significant improvement in daily activities in the SPC group (p = .0033) compared to the infusion therapy group. No statistically significant changes in PTA thresholds were found in both groups between T0 and T24.
CONCLUSION


The preliminary results of our study show a significant reduction of vertigo spells and a positive effect on tinnitus severity and on quality of life in patients with unilateral MD treated with SPC and when compared to patients treated with intravenous glycerol and dexamethasone. No effects on hearing thresholds were noted in both groups.",2020,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"['Twenty-six patients with unilateral MD', ""Ménière's Disease"", 'patients with unilateral MD treated with', ""patients with defined unilateral Meniere's disease (MD""]","['SPC and with intravenous glycerol and dexamethasone', 'endogenous Antisecretory Factor (AF', 'glycerol and dexamethasone', 'intravenous glycerol and dexamethasone', 'SPC', 'endogenous Antisecretory Factor (AF) synthesis using specially processed cereals (SPC']","['Efficacy Index (EI', 'number of vertigo spells', 'daily activities', 'tinnitus severity and on quality of life', 'hearing thresholds', 'hearing loss, tinnitus and quality of life', 'Quality of life', 'vertigo spells', 'PTA thresholds', 'tinnitus score']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0025281', 'cui_str': ""Ménière's disease""}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0052093', 'cui_str': 'antisecretory factor'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0234732', 'cui_str': 'Threshold of hearing'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",26.0,0.0201493,There was a significant reduction for tinnitus score in the SPC group at T24 (p = .0131).,"[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Viola', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Pisani', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Scarpa', 'Affiliation': 'Department of Medicine and Surgery, University of Salerno, Salerno, Italy. Electronic address: alfonsoscarpa@yahoo.it.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cassandro', 'Affiliation': 'Surgical Sciences Department, University of Turin, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Laria', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit of Audiology, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Teodoro', 'Initials': 'T', 'LastName': 'Aragona', 'Affiliation': 'Otolaryngology, A.O.U. Ospedali Riuniti, Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ciriolo', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Spadera', 'Affiliation': 'Otolaryngology, San Leonardo Hospital, Castellammare di Stabia, Napoli, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavaliere', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Iengo', 'Affiliation': 'Department of Neurosciences, Reproductives and Odontostomatologic Sciences, Unit Ear, Nose and Throat Section, University of Naples ""Federico II"", Naples, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Chiarella', 'Affiliation': 'Department of Experimental and Clinical Medicine, Unit of Audiology, Regional Centre for Cochlear Implants and ENT Diseases, Magna Graecia University, Catanzaro, Italy.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102673']
1787,32829105,Determination of the UGT1A1 polymorphism as guidance for irinotecan dose escalation in metastatic colorectal cancer treated with first-line bevacizumab and FOLFIRI (PURE FIST).,"AIM


Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism plays a crucial role in the increased susceptibility of patients to irinotecan and its toxicity. This study is a multicenter, randomised clinical trial comparing the clinical outcomes and adverse events (AEs) in metastatic colorectal cancer (mCRC) patients treated with bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan dose escalation as the first-line therapy.
METHODS


The control group received conventional biweekly FOLFIRI plus bevacizumab without UGT1A1 genotyping, whereas the study group received the same regimen with irinotecan dose escalation based on UGT1A1 genotyping. The primary end-point was progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate.
RESULTS


Over a median follow-up of 26.0 months (IQR, 17.0-35.0 months), study group (n = 107) was superior to the control group (n = 106) in PFS, OS, ORR, DCR, and metastasectomy rate (all P < 0.05). Furthermore, there were no significant differences in AEs ≥ grade III between the two groups, even with the 1.36-fold increase in the relative dose intensity of irinotecan in the study group. Dose escalation of irinotecan, an independent factor of ORR (P < 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
CONCLUSION


The current study revealed that mCRC patients, regardless of KRAS gene status, with UGT1A1 genotyping can tolerate escalated doses of irinotecan and potentially achieve a more favourable clinical outcome without significantly increased toxicities.
CLINICAL TRIAL REGISTRATION


NCT02256800.",2020,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","['metastatic colorectal cancer (mCRC) patients treated with', 'metastatic colorectal cancer treated with first-line']","['bevacizumab plus FOLFIRI with or without UGT1A1 genotyping and irinotecan', 'bevacizumab and FOLFIRI (PURE FIST', 'conventional biweekly FOLFIRI plus bevacizumab', 'irinotecan dose escalation based on UGT1A1 genotyping', 'irinotecan']","['DCR', 'progression-free survival (PFS), and secondary end-points were overall response rate (ORR), disease control rate (DCR), overall survival (OS), AEs and metastasectomy rate', 'PFS', 'PFS, OS, ORR, DCR, and metastasectomy rate', 'toxicities']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041986', 'cui_str': 'Uridine diphosphate'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0336667', 'cui_str': 'Fist'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.0452964,"< 0.001) and DCR (P = 0.006), improved PFS in mCRC patients with wild-type and mutant KRAS (P = 0.007 and P = 0.019, respectively).
","[{'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: chunpin870132@yahoo.com.tw.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: baseball5824@yahoo.com.tw.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lin', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: linyiewen@yahoo.com.tw.'}, {'ForeName': 'Jui-Ho', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan. Electronic address: rayhowang@gmail.com.'}, {'ForeName': 'Chang-Chieh', 'Initials': 'CC', 'LastName': 'Wu', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Keelung Branch, Tri-Service General Hospital, Keelung, Taiwan. Electronic address: doc20276@gmail.com.'}, {'ForeName': 'Yung-Chuan', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Taipei Cathay General Hospital, Taipei, Taiwan. Electronic address: yungchuans@cgh.org.tw.'}, {'ForeName': 'Tzu-Liang', 'Initials': 'TL', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: golfma22@gmail.com.'}, {'ForeName': 'Hwei-Ming', 'Initials': 'HM', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: phillipwhm@gmail.com.'}, {'ForeName': 'Hsiu-Chin', 'Initials': 'HC', 'LastName': 'Tang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Tainan Sin-Lan Hospital, Tainan, Taiwan. Electronic address: schoetz.tang@gmail.com.'}, {'ForeName': 'Joe-Bin', 'Initials': 'JB', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung, Taiwan. Electronic address: jbchen@vghtc.gov.tw.'}, {'ForeName': 'Tao-Wei', 'Initials': 'TW', 'LastName': 'Ke', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Taichung China Medical University Hospital, Taichung, Taiwan. Electronic address: ketaowei@gmail.com.'}, {'ForeName': 'Chang-Sung', 'Initials': 'CS', 'LastName': 'Tsai', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan. Electronic address: chonsonechai@gmail.com.'}, {'ForeName': 'Hsuan-Yuan', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan. Electronic address: 107431@cch.org.tw.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan. Electronic address: cy614112@ms14.hinet.net.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.05.031']
1788,32829109,High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production in obese men in response to an acute exercise bout.,"The aim of this study was to evaluate the inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin) profile of inactive obese men in response to two isoenergetic models of aerobic exercise training (~300  kcal each exercise session). Twenty-two participants (28.7 ± 1.6 years; BMI = 34.4 ± 0.1 kg/m 2 ) were randomized into two groups: I) HIIT: high-intensity interval training (10× 1 bout: 1 min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT). Both groups trained three times per week for 6-weeks. Fasting blood samples were collected before and 0, 30, and 60 min after exercise during the first and last training sessions for evaluation of: I) MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10 were analyzed before, 0, and 60 min after sessions. IL-6 concentration remained elevated up to 60-min after the acute exercise session (p < 0.001), and IL-10 concentration was higher after 30 and 60-min (p = 0.001) compared to rest, independent of training period and protocol. AUC of IL-10 presented effect of type of training (p = 0.023) with MICT group showed significantly higher values than the HIIT. The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period. Fifteen subjects presented decreased HOMA-IR after 6-weeks and seven presented an increase in this index. When we excluded the two least responsive subjects, it was possible to observe a decrease in HOMA-IR (p = 0.020) after training. Taken together, our results suggest that both HIIT and MICT (with same energy expenditure) promote similar effects on HOMA-IR and led to elevations in IL-10 production in LPS-stimulated whole blood, suggesting that leukocytes had an enhanced ability to secrete anti-inflammatory cytokines after the exercise bout.",2020,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","['Twenty-two participants (28.7\xa0±\xa01.6\xa0years; BMI\xa0=\xa034.4\xa0±\xa00.1\xa0kg/m 2 ', 'obese men in response to an acute exercise bout', 'inactive obese men']","['MICT', 'HIIT and MICT', 'IL-6', 'inflammatory (peripheral and lipopolysaccharide (LPS)-stimulated released from whole blood) and metabolic (glucose and insulin', 'HIIT: high-intensity interval training (10× 1 bout: 1\xa0min - 100% Maximal Aerobic Velocity) or II) MICT: moderate-intensity continuous training (65% Maximal Aerobic Velocity; kcal equal to HIIT', 'aerobic exercise training', 'High- and moderate-intensity training modify LPS-induced ex-vivo interleukin-10 production']","['MIP-1ɑ, insulin, glucose, visceral and subcutaneous fat depots, oral glucose tolerance test, and homeostatic model assessment of insulin resistance (HOMA-IR) index; II) Peripheral (TNF-α, IL-6, and IL-10) and LPS-stimulated release of TNF-α and IL-10', 'HOMA-IR', 'Fasting blood samples', 'IL-10 secretion', 'concentration', 'IL-10 concentration']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]","[{'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0237388,"The ex-vivo assay showed higher IL-10 secretion in response to LPS immediately (p = 0.003) after both acute MICT and HIIT exercise sessions, independent of training period.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Gerosa-Neto', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil; Physical Education, Physiotherapy, University Center of Maringa (UniCesumar), Parana, Brazil.'}, {'ForeName': 'Paula Alves', 'Initials': 'PA', 'LastName': 'Monteiro', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Daniela Sayuri', 'Initials': 'DS', 'LastName': 'Inoue', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Barbara Moura', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Batatinha', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Gilson Pires', 'Initials': 'GP', 'LastName': 'Dorneles', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Peres', 'Affiliation': 'Department of Health Basic Science, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'José Cesar', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Department of Cell and Developmental Biology, Institute of Biomedical Sciences, University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post graduation Program in Movement Sciences, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, São Paulo, Brazil. Electronic address: fabio.lira@unesp.br.'}]",Cytokine,['10.1016/j.cyto.2020.155249']
1789,32829666,Effects of Intensive Versus Standard Office-Based Hypertension Treatment Strategy on White-Coat Effect and Masked Uncontrolled Hypertension: From the SPRINT ABPM Ancillary Study.,"Guidelines recommend using out-of-office blood pressure (BP) measurements to confirm the diagnoses of hypertension and in the titration of antihypertensive medication. The prevalence of out-of-office BP phenotypes for an office systolic/diastolic BP goal <140/90 mm Hg has been reported. However, the prevalence of these phenotypes when targeting an office systolic/diastolic BP goal <120/80 is unknown. The SPRINT (Systolic Blood Pressure Intervention Trial) Ambulatory BP Ancillary study evaluated out-of-office BP using ambulatory BP monitoring in 897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg). We used office and daytime BP to assess the proportion of participants with white-coat effect (standard target: office BP ≥140/90 mm Hg and daytime BP <135/85 mm Hg versus intensive target: office BP ≥120/80 mm Hg and daytime BP <120/80 mm Hg) and masked uncontrolled hypertension (standard target: office BP <140/90 mm Hg and daytime BP ≥135/85 mm Hg versus intensive target: office BP <120/80 mm Hg and daytime BP ≥120/80 mm Hg) in each treatment arm. The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups. Among participants with uncontrolled office BP, white-coat effect was present in 20% and 23% in the intensive and standard groups, respectively. Among participants with controlled office BP, masked uncontrolled hypertension was present in 62% and 56% in the intensive and standard groups, respectively. In conclusion, a more intensive BP target resulted in a similar proportion of patients with white-coat effect and masked uncontrolled hypertension compared with a standard target.",2020,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","['897 participants 27 months after randomization to intensive versus standard BP targets (office systolic BP <120 versus <140 mm Hg', 'White-Coat Effect and Masked Uncontrolled Hypertension', 'participants with white-coat effect (standard target']",['Intensive Versus Standard Office-Based Hypertension Treatment Strategy'],"['prevalence of white-coat effect and masked uncontrolled hypertension', 'uncontrolled hypertension']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0578998', 'cui_str': 'On treatment for hypertension'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]",27.0,0.101849,"The prevalence of white-coat effect and masked uncontrolled hypertension was 9% and 34%, in both treatment groups.","[{'ForeName': 'Lama', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Cohen', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Alabama at Birmingham (P.M.).'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'The Columbia Hypertension Center, Columbia University, New York, NY (L.P.C., D.S.).'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'From the Division of Renal Diseases and Hypertension, University of Minnesota, Minneapolis (L.G., P.E.D.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15300']
1790,32831069,Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.,"BACKGROUND


Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed.
METHODS AND DESIGN


We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption.
TRIAL REGISTRATION


ClinicalTrials.gov . Identifier: NCT03672487 . Registered 14 September 2018.",2020,"BACKGROUND


Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life.","['cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy', 'treated women when pregnant later in life', 'women of reproductive age (BETTY', 'women of reproductive age', 'cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum']","['BZN 150\u2009mg/day (30d/150\u2009mg) vs. BZN 60d/300', 'Benznidazole treatment', 'BZN 30d/150\u2009mg compared to 60d/300\u2009mg preconceptional treatment', 'Benznidazole (BZN']","['frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR', 'Trypanosoma cruzi parasitic load']","[{'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0053230', 'cui_str': 'benznidazole'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0041221', 'cui_str': 'Trypanosoma cruzi'}, {'cui': 'C3178765', 'cui_str': 'Parasitic Load'}]",,0.409211,"BACKGROUND


Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life.","[{'ForeName': 'María L', 'Initials': 'ML', 'LastName': 'Cafferata', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina. mcafferata@iecs.org.ar.'}, {'ForeName': 'María A', 'Initials': 'MA', 'LastName': 'Toscani', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Althabe', 'Affiliation': 'Maternal and Perinatal Health. UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research (SRH), World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Belizán', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bergel', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Mabel', 'Initials': 'M', 'LastName': 'Berrueta', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego (UCSD), San Diego, USA.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Ciganda', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Emmaria', 'Initials': 'E', 'LastName': 'Danesi', 'Affiliation': 'Centro Nacional de Diagnóstico e Investigación en Endemoepidemias (CeNDIE) ANLIS Dr. C. G. Malbrán, Buenos Aires, Argentina.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dumonteil', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Gibbons', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Gulayin', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Herrera', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}, {'ForeName': 'Jeremiah D', 'Initials': 'JD', 'LastName': 'Momper', 'Affiliation': 'Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego (UCSD), San Diego, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': 'Schools of Medicine, University of California, San Diego (UCSD), San Diego, USA.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Shaffer', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Schijman', 'Affiliation': 'Laboratorio de Biología Molecular de la Enfermedad de Chagas (LaBMECh), Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ""Dr. Héctor Torres"" (INGEBI), Buenos Aires, Argentina.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sosa-Estani', 'Affiliation': 'Drugs for Neglected Diseases initiative - Latin America (DNDi), Rio de Janeiro, Brazil.'}, {'ForeName': 'Candela B', 'Initials': 'CB', 'LastName': 'Stella', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'Instituto de Efectividad Clinica y Sanitaria (IECS), Buenos Aires, Argentina.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Buekens', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, USA.'}]",Reproductive health,['10.1186/s12978-020-00972-1']
1791,32831097,Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke.,"BACKGROUND


Hand function is often impaired after stroke, strongly affecting the ability to perform daily activities. Upper limb robotic devices have been developed to complement rehabilitation therapy offered to persons who suffered a stroke, but they rarely focus on the training of hand sensorimotor function. The primary goal of this study was to evaluate whether robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks) produces an equivalent decrease in upper limb motor impairment compared to dose-matched conventional neurocognitive therapy, when embedded in the rehabilitation program of inpatients in the subacute stage after stroke.
METHODS


A parallel-group, randomized controlled trial was conducted on subjects with subacute stroke receiving either conventional or robot-assisted neurocognitive hand therapy using a haptic device. Therapy was provided for 15, 45-min sessions over four weeks, nested within the standard therapy program. Primary outcome was the change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE) after the intervention, which was compared between groups using equivalence testing. Secondary outcome measures included upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance.
RESULTS


Thirty-three participants with stroke were enrolled. 14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study. At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
CONCLUSIONS


Neurocognitive robot-assisted therapy of hand function allows for a non-inferior motor recovery compared to conventional dose-matched neurocognitive therapy when performed during inpatient rehabilitation in the subacute stage. This allows the early familiarization of subjects with stroke to the use of such technologies, as a first step towards minimal therapist supervision in the clinic, or directly at home after hospital discharge, to help increase the dose of hand therapy for persons with stroke.
TRIAL REGISTRATION


EUDAMED database (CIV-13-02-009921), clinicaltrials.gov (NCT02096445). Registered 26 March 2014 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02096445.",2020,"At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
","['subjects with stroke', 'subjects with subacute stroke receiving either', 'subacute stroke', 'Thirty-three participants with stroke were enrolled', 'inpatients in the subacute stage after stroke', '14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study', 'persons with stroke']","['conventional or robot-assisted neurocognitive hand therapy using a haptic device', 'conventional dose-matched neurocognitive therapy', 'robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks', 'Neurocognitive robot-assisted rehabilitation of hand function']","['upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance', 'upper limb motor impairment', 'change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0729315', 'cui_str': 'Hand therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1268196', 'cui_str': 'Upper extremity part'}]",33.0,0.0737425,"At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.
","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Ranzani', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland. relab.publications@hest.ethz.ch.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Lambercy', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Metzger', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Califfi', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Regazzi', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Dinacci', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Petrillo', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rossi', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Conti', 'Affiliation': 'Clinica Hildebrand Centro di Riabilitazione Brissago, Via Crodolo, 6614, Brissago, Switzerland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Gassert', 'Affiliation': 'Rehabilitation Engineering Laboratory, Institute of Robotics and Intelligent Systems, Department of Health Sciences and Technology, BAA Lengghalde 5, 8008, Zurich, Switzerland.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00746-7']
1792,32846174,Heart rate variability in healthy young adults exposed to global system for mobile communication (GSM) 900-MHz radiofrequency signal from mobile phones.,"Given the large number of mobile phone users and the increasing exposure to radiofrequency electromagnetic field (RF-EMF) worldwide, we aimed to study the effect of RF-EMF related to mobile phones on heart rate variability (HRV). Twenty-six healthy young adults participated in two experimental sessions with a double-blind, randomized and counter-balanced crossover design. During each session, participants were exposed for 26 min to a sham or real 900 MHz RF-EMF, generated by a commercial dual-band Global System for Mobile technology (GSM) mobile phone. We recorded an electrocardiogram at rest during the exposure. We evaluated HRV by time- and frequency-domain analysis. Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure. Other time-domain parameters were not affected. Analysis in the frequency-domain demonstrated that total spectral power and low-frequency band (LF) absolute power were significantly increased during exposure (p = .046 and p = .043, respectively). However, other parameters were not affected. In conclusion, it seems that most HRV parameters were not affected by GSM signal exposure in our study. The weak effect observed on HRV frequency-domain is likely to represent a random occurrence rather than a real effect.",2020,Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure.,"['healthy young adults', 'Twenty-six healthy young adults']","['RF-EMF', 'global system for mobile communication (GSM) 900-MHz radiofrequency signal from mobile phones', 'sham or real 900 MHz RF-EMF, generated by a commercial dual-band Global System for Mobile technology (GSM) mobile phone']","['Heart rate variability', 'heart rate variability (HRV', 'total spectral power and low-frequency band (LF) absolute power', 'standard deviation of interbeat intervals (SDNN']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175723', 'cui_str': 'Band'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",26.0,0.0704992,Evaluation of time-domain HRV parameters revealed a statistically significant increase of the standard deviation of interbeat intervals (SDNN) during the real exposure.,"[{'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Wallace', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.""}, {'ForeName': 'Soafara', 'Initials': 'S', 'LastName': 'Andrianome', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.""}, {'ForeName': 'Rania', 'Initials': 'R', 'LastName': 'Ghosn', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.""}, {'ForeName': 'Erwan Stephan', 'Initials': 'ES', 'LastName': 'Blanchard', 'Affiliation': 'PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Telliez', 'Affiliation': 'PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Selmaoui', 'Affiliation': ""Department of Experimental Toxicology, Institut National de L'Environnement Industriel et des Risques (INERIS), 60550, Verneuil-en-Halatte, France; PériTox Laboratory, UMR-I 01 INERIS, Picardie Jules Verne University, 80025, Amiens, France. Electronic address: brahim.selmaoui@ineris.fr.""}]",Environmental research,['10.1016/j.envres.2020.110097']
1793,32846328,Factors associated with discontinuation in the drug and placebo groups of trials of second generation antipsychotics for acute schizophrenia: A meta-regression analysis: Discontinuation in antipsychotic trials.,"This study investigated factors associated with discontinuation in double-blind, randomized, placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs) for acute schizophrenia, with a view to establishing what factors were associated with all-cause discontinuation. 77 eligible studies (96 comparisons; n = 22,678) were included in this study. Thirty-one factors potentially affecting all-cause discontinuation, related to the participants, study design, and drugs, were included in a meta-regression analysis that examined the factors associated with discontinuation rates in treatment and placebo groups and/or the treatment-placebo group difference in discontinuation. Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group. These factors were also associated with the treatment-placebo group difference in discontinuation. Although the risk of weight gain from SGA use was not associated with discontinuation rates in either the treatment or placebo groups, SGAs with a risk of weight gain were associated with a larger treatment-placebo group difference in discontinuation, although the reason is unknown. Factors associated with discontinuation rates in both treatment and placebo groups did not influence the treatment-placebo group difference in discontinuation. The efficacy and the risk of weight gain of SGAs seemed to influence treatment-placebo group difference in discontinuation in DBRPCTs of SGAs for acute schizophrenia.",2020,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","['acute schizophrenia', '77 eligible studies (96 comparisons; n\xa0=\xa022,678']","['placebo', 'placebo-controlled trials (DBRPCTs) of second-generation antipsychotics (SGAs']","['Positive and Negative Syndrome Scale total scores', 'discontinuation rates', 'smaller response rates', 'weight gain']","[{'cui': 'C0857501', 'cui_str': 'Acute schizophrenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",22678.0,0.223392,"Smaller improvements in Positive and Negative Syndrome Scale total scores from baseline to endpoint were associated with higher discontinuation rates in both the treatment and placebo groups, and smaller response rates in the treatment group were associated with higher discontinuation rates in the treatment group.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan. Electronic address: tarok@fujita-hu.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Okuya', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.08.003']
1794,32846334,Effectiveness of pulmonary rehabilitation at high-altitude compared to sea-level in adults with severe refractory asthma.,"BACKGROUND


Beneficial effects of pulmonary rehabilitation at high-altitude (HAPR) in patients with severe refractory asthma have been reported earlier, but evidence for the effectiveness is limited.
AIM


To investigate the effectiveness of high-altitude pulmonary rehabilitation to comparable treatment at sea-level (LAPR) on patient outcome parameters.
METHODS


Adults with severe refractory asthma living in The Netherlands were included. Treatment consisted of a 12-week personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n = 93) or in a tertiary lung center at sea-level in The Netherlands (n = 45). At baseline, after treatment, and during 12 months follow-up asthma related quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose were assessed. Patients could not be randomized resulting in different asthma populations. Groups were compared using linear regression analysis (ANCOVA) adjusted for baseline values, in addition to age, atopy, smoking history, BMI and gender.
RESULTS


After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear regression analysis-5.29 mg, p = 0.003 and Crude Odds Ratio-1.67, p = 0.003, respectively) were observed in the HAPR-group compared to the LAPR group. Patients receiving HAPR also had less asthma exacerbations (≥1 exacerbation: 20% vs 60%,p < 0.001) and showed improvement in lung function (%predFEV 1  3.4%,p = 0.014) compared to the LAPR group, but at 12 months no differences between groups were observed.
CONCLUSION


HAPR resulted in a larger improvement in patient outcome parameters compared to LAPR, on the long run the improvement in patient reported symptoms and lower maintenance OCS-dose persists. Underlying factors that explain this observed effect need to be investigated.",2020,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","['patients with severe refractory asthma', 'adults with severe refractory asthma', 'Adults with severe refractory asthma living in The Netherlands were included']","['personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n\xa0=\xa093) or in a tertiary lung center at sea-level in The Netherlands', 'pulmonary rehabilitation at high-altitude (HAPR', 'HAPR', 'high-altitude pulmonary rehabilitation', 'pulmonary rehabilitation']","['asthma exacerbations', 'lung function', 'quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.06858,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'de Nijs', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands; Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Krop', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Portengen', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Rijssenbeek-Nouwens', 'Affiliation': 'Dutch Asthma Center Davos, Davos, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Vries', 'Affiliation': 'Merem Asthma Center Heideheuvel, Hilversum, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Weersink', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'H G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands. Electronic address: H.G.M.Heijerman@umcutrecht.nl.'}, {'ForeName': 'D J J', 'Initials': 'DJJ', 'LastName': 'Heederik', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106123']
1795,32846388,A Randomised Controlled Trial Examining the Effects of Self-Compassion Meditations on Women's Body Image.,"Although research has suggested that body image improves following self-compassion meditation training, studies have been limited due to the use of a wait-list control group. This study therefore compared the effects of self-compassion meditations to an active control group. Seventy young adult women (17-35 years) were randomly assigned to receive either self-compassion or nature-focused guided imagery meditations. Over one week, participants engaged in two meditations and completed pre- and post-test measures of trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth. A mixed design analysis of variance revealed a main effect of time; women in both meditation groups demonstrated significant increases in self-compassion and body appreciation, and significant reductions in body shame. No effect was found for appearance-contingent self-worth. There were no interactions or main effects for group. Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations. Common elements between self-compassion and guided imagery may be a mechanism for improving body image. However, further research is warranted to isolate the effects of these meditations from other specific and non-specific treatment effects. (This study was pre-registered with the Australian New Zealand Clinical Trials Registry, ACTRN12618001814268).",2020,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","['Seventy young adult women (17-35 years', ""Women's Body Image""]","['Self-Compassion Meditations', 'self-compassion or nature-focused guided imagery meditations']","['self-compassion and body appreciation', 'body shame', 'trait self-compassion, body appreciation, body shame, and appearance-contingent self-worth']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",70.0,0.0359798,"Self-compassion may improve body image in women, although there was no evidence for an advantage of self-compassion over guided imagery meditations.","[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'de Wet', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: a_d088@student.usc.edu.au.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'Centre for Human Factors and Sociotechnical Systems, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: blane@usc.edu.au.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, QLD, 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.07.009']
1796,32839161,Improving pain management in childhood acute otitis media in general practice: a cluster randomised controlled trial of a GP-targeted educational intervention.,"BACKGROUND


Pain management in acute otitis media (AOM) is often suboptimal, potentially leading to unnecessary discomfort, GP reconsultation, and antibiotic prescribing.
AIM


To assess the effectiveness of a GP-targeted educational intervention to improve pain management in children with AOM.
DESIGN AND SETTING


Pragmatic, cluster randomised controlled trial (RCT). GPs in 37 practices (intervention  n  = 19; control  n  = 18) across the Netherlands recruited 224 children with GP-confirmed AOM and ear pain (intervention  n  = 94; control  n  = 130) between February 2015 and May 2018.
METHOD


GPs in practices allocated to the intervention group were trained (online and face-to-face) to discuss pain management with parents using an information leaflet, and prompted to prescribe weight-appropriate dosed paracetamol. Ibuprofen was additionally prescribed if pain control was still insufficient. GPs in the control group provided usual care.
RESULTS


Mean ear pain scores over the first 3 days were similar between groups (4.66 versus 4.36; adjusted mean difference = -0.05; 95% confidence intervals [CI] = -0.93 to 0.83), whereas analgesic use, in particular ibuprofen, was higher in the intervention group. The total number of antibiotic prescriptions during the 28-day follow-up was similar (mean rate 0.43 versus 0.47; adjusted rate ratio [aRR] 0.97; 95% CI = 0.68 to 1.38). Parents of children in the intervention group were more likely to reconsult for AOM-related complaints (mean rate 0.70 versus 0.41; aRR 1.73; 95% CI = 1.14 to 2.62).
CONCLUSION


An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit. GPs are advised to carefully weigh the potential benefits of ibuprofen against its possible harms.",2020,"An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit.","['childhood acute otitis media in general practice', 'acute otitis media (AOM', '37 practices (intervention  n  = 19; control  n  = 18) across the Netherlands recruited 224 children with GP-confirmed AOM and ear pain (intervention  n  = 94; control  n  = 130) between February 2015 and May 2018', 'children with AOM']","['Ibuprofen', 'intervention group were trained (online and face-to-face) to discuss pain management with parents using an information leaflet, and prompted to prescribe weight-appropriate dosed paracetamol', 'GP-targeted educational intervention', 'ibuprofen']","['AOM-related complaints', 'Mean ear pain scores', 'pain management', 'total number of antibiotic prescriptions']","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013456', 'cui_str': 'Otalgia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",224.0,0.136145,"An intervention aimed at improving pain management for AOM increases analgesic use, particularly ibuprofen, but does not provide symptomatic benefit.","[{'ForeName': 'Rick T', 'Initials': 'RT', 'LastName': 'van Uum', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Roderick P', 'Initials': 'RP', 'LastName': 'Venekamp', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas Pa', 'Initials': 'NP', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Alies', 'Initials': 'A', 'LastName': 'Sjoukes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Alma C', 'Initials': 'AC', 'LastName': 'van de Pol', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Anne Gm', 'Initials': 'AG', 'LastName': 'Schilder', 'Affiliation': 'University College London; National Institute for Health Research research professor evidENT, Ear Institute, University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'Roger Amj', 'Initials': 'RA', 'LastName': 'Damoiseaux', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X712589']
1797,32840126,Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.,"BACKGROUND


Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy.
METHODS


We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 ratio) to receive oral RPF (3.36 g/day) or placebo daily for 6 weeks. The main outcome was the Functional Assessment of Cancer Therapy-Lung (FACT-L). We evaluated RPF's safety profile using the Common Terminology Criteria for Adverse Events and assessed changes in outcome measures from baseline to weeks 3 and 6 using a linear mixed effects model.
RESULTS


We enrolled 82 participants across 8 cancer centers in China. The median age was 59 years, 56 (68%) had advanced cancer. Compared with the placebo group, the RPF group had nonstatistically significant higher quality of life as measured by the FACT-L total score ( P  = .086) over 2 cycles of chemotherapy. The RPF group was associated with a nonsignificant better general health ( P  = .050) and emotional well-being ( P  = .090) than the placebo group. Adverse events rates did not differ between groups.
CONCLUSIONS


This study demonstrated preliminary safety and suggests a promising trend in RPF's effect on maintaining quality of life and emotional well-being among NSCLC patients undergoing chemotherapy. Future adequately powered randomized-controlled trials are needed to verify the efficacy and safety of RPF in cancer patients undergoing chemotherapy.",2020,The RPF group was associated with a nonsignificant better general health ( P  = .050) and emotional well-being ( P  = .090) than the placebo group.,"['NSCLC patients undergoing chemotherapy', 'cancer patients undergoing chemotherapy', '82 participants across 8 cancer centers in China', 'Adults with NSCLC scheduled to receive', 'Cancer patients', 'The median age was 59 years, 56 (68%) had advanced cancer', 'patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy', 'China', 'Non-Small Cell Lung Cancer Patients']","['Undergoing Chemotherapy', 'Reishi & Privet Formula', 'Reishi & Privet Formula (RPF', 'oral RPF', 'placebo', 'Placebo', 'RPF', 'chemotherapy']","['Quality of Life', 'general health', 'FACT-L total score', 'Adverse events rates', 'quality of life', 'Functional Assessment of Cancer Therapy-Lung']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0752326', 'cui_str': 'Lingzhi'}, {'cui': 'C0995160', 'cui_str': 'Genus Ligustrum'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",82.0,0.770987,The RPF group was associated with a nonsignificant better general health ( P  = .050) and emotional well-being ( P  = .090) than the placebo group.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Susan Qing', 'Initials': 'SQ', 'LastName': 'Li', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Guang An Men Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420944491']
1798,32840597,Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children With Asthma and Low Vitamin D Levels: The VDKA Randomized Clinical Trial.,"Importance


Severe asthma exacerbations cause significant morbidity and costs. Whether vitamin D3 supplementation reduces severe childhood asthma exacerbations is unclear.
Objective


To determine whether vitamin D3 supplementation improves the time to a severe exacerbation in children with asthma and low vitamin D levels.
Design, Setting, and Participants


The Vitamin D to Prevent Severe Asthma Exacerbations (VDKA) Study was a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to improve the time to severe exacerbations in high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers. Enrollment started in February 2016, with a goal of 400 participants; the trial was terminated early (March 2019) due to futility, and follow-up ended in September 2019.
Interventions


Participants were randomized to vitamin D3, 4000 IU/d (n = 96), or placebo (n = 96) for 48 weeks and maintained with fluticasone propionate, 176 μg/d (6-11 years old), or 220 μg/d (12-16 years old).
Main Outcomes and Measures


The primary outcome was the time to a severe asthma exacerbation. Secondary outcomes included the time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid was reduced halfway through the trial, and the cumulative fluticasone dose during the trial.
Results


Among 192 randomized participants (mean age, 9.8 years; 77 girls [40%]), 180 (93.8%) completed the trial. A total of 36 participants (37.5%) in the vitamin D3 group and 33 (34.4%) in the placebo group had 1 or more severe exacerbations. Compared with placebo, vitamin D3 supplementation did not significantly improve the time to a severe exacerbation: the mean time to exacerbation was 240 days in the vitamin D3 group vs 253 days in the placebo group (mean group difference, -13.1 days [95% CI, -42.6 to 16.4]; adjusted hazard ratio, 1.13 [95% CI, 0.69 to 1.85]; P = .63). Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial. Serious adverse events were similar in both groups (vitamin D3 group, n = 11; placebo group, n = 9).
Conclusions and Relevance


Among children with persistent asthma and low vitamin D levels, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation. The findings do not support the use of vitamin D3 supplementation to prevent severe asthma exacerbations in this group of patients.
Trial Registration


ClinicalTrials.gov Identifier: NCT02687815.",2020,"Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial.","['children with asthma and low vitamin D levels', 'children with persistent asthma and low vitamin D levels', ' 77 girls [40%]), 180 (93.8%) completed the trial', '192 randomized participants (mean age, 9.8 years', 'Children With Asthma and Low Vitamin D Levels', 'high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers']","['Vitamin D', 'fluticasone propionate', 'vitamin D3', 'placebo', 'placebo, vitamin D3 supplementation', 'Vitamin D3 Supplementation', 'vitamin D3 supplementation', 'Vitamin D3 supplementation']","['severe childhood asthma exacerbations', 'Severe Asthma Exacerbations (VDKA', 'time to a severe exacerbation', 'time to a severe asthma exacerbation', 'Serious adverse events', 'Severe Asthma Exacerbations', 'mean time to exacerbation', 'severe exacerbations', 'time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid', 'time to severe exacerbations', 'time to a viral-induced severe exacerbation', 'severe asthma exacerbations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4285871', 'cui_str': 'Vitamin D low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",192.0,0.78948,"Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial.","[{'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Forno', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St Louis Children's Hospital, Washington University at St Louis, St Louis, Missouri.""}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Allergy and Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Theresa W', 'Initials': 'TW', 'LastName': 'Guilbert', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, University of California, San Francisco Benioff Children's Hospital, University of California, San Francisco.""}, {'ForeName': 'Kristie', 'Initials': 'K', 'LastName': 'Ross', 'Affiliation': ""Division of Pediatric Pulmonology, University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, Ohio.""}, {'ForeName': 'Ronina', 'Initials': 'R', 'LastName': 'Covar', 'Affiliation': 'Division of Allergy and Immunology, Department of Pediatrics, National Jewish Health, University of Colorado, Denver.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gern', 'Affiliation': 'Department of Pediatrics, University of Wisconsin-Madison School of Medicine and Public Health, Madison.'}, {'ForeName': 'Franziska J', 'Initials': 'FJ', 'LastName': 'Rosser', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Blatter', 'Affiliation': ""Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St Louis Children's Hospital, Washington University at St Louis, St Louis, Missouri.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, Cincinnati Children's Hospital, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Yueh-Ying', 'Initials': 'YY', 'LastName': 'Han', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Celedón', 'Affiliation': ""Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.""}]",JAMA,['10.1001/jama.2020.12384']
1799,32840598,Effect of Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy on Ischemic Outcomes After Percutaneous Coronary Intervention: The TAILOR-PCI Randomized Clinical Trial.,"Importance


After percutaneous coronary intervention (PCI), patients with CYP2C19*2 or *3 loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown.
Objective


To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes in CYP2C19 LOF carriers after PCI.
Design, Setting, and Participants


Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019.
Interventions


Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping. CYP2C19 LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months.
Main Outcomes and Measures


The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients with CYP2C19 LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50.
Results


Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 with CYP2C19 LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903 CYP2C19 LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02]; P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07]; P = .16).
Conclusions and Relevance


Among CYP2C19 LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months.
Trial Registration


ClinicalTrials.gov Identifier: NCT01742117.",2020,"None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58).","['CYP2C19 LOF carriers after PCI', 'patients with CYP2C19', '5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial', '5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD', 'Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019']","['conventional therapy received clopidogrel', 'percutaneous coronary intervention (PCI', 'oral P2Y12 inhibitor therapy', 'genotype-guided group (n\u2009=\u20092652) underwent point-of-care genotyping', 'Genotype-Guided Oral P2Y12 Inhibitor Selection vs Conventional Clopidogrel Therapy', 'clopidogrel', 'ticagrelor', 'genotype-guided oral P2Y12 inhibitor strategy']","['major or minor bleeding', 'cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia', 'Ischemic Outcomes', 'risk of ischemic events', 'ischemic outcomes', 'major or minor bleeding in CYP2C19 LOF carriers', 'composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia']","[{'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",5302.0,0.146849,"None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding in CYP2C19 LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51]; P = .58).","[{'ForeName': 'Naveen L', 'Initials': 'NL', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre and Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Lennon', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Verghese', 'Initials': 'V', 'LastName': 'Mathew', 'Affiliation': 'Department of Medicine, Loyola University, Maywood, Illinois.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Bell', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Jang-Ho', 'Initials': 'JH', 'LastName': 'Bae', 'Affiliation': 'Department of Internal Medicine, Division of Cardiology, Konyang University, Seo-gu, Taejon, South Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Heart Research Center, Chonnam National University, Gwangju, South Korea.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Chavez', 'Affiliation': 'Department of Cardiology, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gordon', 'Affiliation': 'Division of Cardiology, The Miriam Hospital, Providence, Rhode Island.'}, {'ForeName': 'J Dawn', 'Initials': 'JD', 'LastName': 'Abbott', 'Affiliation': 'Division of Cardiology, Rhode Island Hospital, Providence, Rhode Island.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cagin', 'Affiliation': 'Mayo Clinic Health System-La Crosse, La Crosse, Wisconsin.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Baudhuin', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Yi-Ping', 'Initials': 'YP', 'LastName': 'Fu', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Iturriaga', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Sidhu', 'Affiliation': 'Division of Cardiology, Department of Medicine, Albany Medical Center and Albany Medical College, Albany, New York.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Liewei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Weinshilboum', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'Department of Medicine, Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Charanjit', 'Initials': 'C', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}]",JAMA,['10.1001/jama.2020.12443']
1800,32833478,"The positive affect, promoting Positive Engagement, and Adherence for Life (APPEAL) feasibility trial: Design and rationale.","OBJECTIVE


To describe development of the Positive Affect, Promoting Positive Engagement, and Adherence for Life (APPEAL) program.
METHOD


APPEAL is intended to increase HIV medication adherence through promotion of positive affect, and was developed through an iterative process involving 6 focus groups (N = 34) that elicited feedback on intervention content, followed by an individually administered prepilot of the entire intervention (N = 7).
RESULTS


Participants provided feedback on important potential moderator variables, including depression, on mode of intervention administration, and on anticipated barriers and benefits to participation. Insights gained were used to finalize study procedures in preparation for a feasibility trial. For the feasibility trial, a total of 80 participants who, in the past 6 months have had at least one plasma HIV RNA >200 copies/mL, will be randomized to receive APPEAL or standard of care (N = 40 per group). Intervention group participants will receive 3 monthly, individually administered sessions, and all participants will have their medication adherence monitored and complete structured interviews at baseline and at 3 and 6 months.
CONCLUSION


The APPEAL program is innovative in that it focuses on promoting self-regulation of positive emotions, an understudied approach to promoting chronic disease self-management behaviors such as HIV medication adherence. Findings from the feasibility trial will gauge suitability of the APPEAL intervention and evaluation methods for subsequent testing in a confirmatory trial and will examine changes in positive affect, the primary mechanism of change targeted in the intervention. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The APPEAL program is innovative in that it focuses on promoting self-regulation of positive emotions, an understudied approach to promoting chronic disease self-management behaviors such as HIV medication adherence.","['80 participants who, in the past 6 months have had at least one plasma HIV RNA >200 copies/mL']",[],['HIV medication adherence'],"[{'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",80.0,0.100332,"The APPEAL program is innovative in that it focuses on promoting self-regulation of positive emotions, an understudied approach to promoting chronic disease self-management behaviors such as HIV medication adherence.","[{'ForeName': 'Tracey E', 'Initials': 'TE', 'LastName': 'Wilson', 'Affiliation': 'Department of Community Health Sciences and Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Chanée', 'Initials': 'C', 'LastName': 'Massiah', 'Affiliation': 'Department of Epidemiology and Biostatistics, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Radigan', 'Affiliation': 'Department of Epidemiology and Biostatistics, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'DeHovitz', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Usha S', 'Initials': 'US', 'LastName': 'Govindarajulu', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Holman', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Melendez', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Jameela', 'Initials': 'J', 'LastName': 'Yusuff', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, State University of New York, Downstate Health Sciences University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000880']
1801,32835786,Attachment anxiety moderates the effect of oxytocin on negative emotion recognition: Evidence from eye-movement data.,"Valence-specific effects of oxytocin have been revealed in a selection of preceding studies, while others report that oxytocin could improve facial recognition, regardless of emotion valence. The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition. In this study, we used eye tracking to test whether attachment style moderates the effect of oxytocin on negative emotion recognition, which is crucial for social cognition. We employed a placebo-controlled, double-blind, within-participants design. The participants were 73 healthy individuals (41 men) who received a single dose of intranasal oxytocin (24 IU) on one occasion and a placebo dose on another occasion. Visual attention to the eye region was assessed on both occasions, through the completion of an emotion recognition task. Our results showed that oxytocin increased participants' eye gaze towards facial expressions. Among participants who received oxytocin, as opposed to a placebo, only individuals with high attachment anxiety displayed more eye gaze and less mouth gaze towards facial expression, regardless of emotion valence. Our findings confirmed that oxytocin increases gaze to the eye region, thus improving facial recognition, regardless of emotion valence, this relationship was moderated by attachment anxiety. Further, our results highlighted the importance of considering individual differences when evaluating the effects of oxytocin on emotion recognition.",2020,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.",['participants were 73 healthy individuals (41 men) who received a single dose of'],"['intranasal oxytocin', 'placebo', 'oxytocin']","['social behavior and cognition', 'eye gaze and less mouth gaze towards facial expression, regardless of emotion valence', 'emotion recognition', 'facial recognition, regardless of emotion valence', ""participants' eye gaze towards facial expressions"", 'eye gaze', 'negative emotion recognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0871740', 'cui_str': 'Face Perception'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",73.0,0.296375,"The reported effect was mediated by increased eye gaze during face processing, and attachment style proved to moderate the effect of oxytocin administration on social behavior and cognition.","[{'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Qingting', 'Initials': 'Q', 'LastName': 'Tang', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Faculty of Psychology, Southwest University, Chongqing 400175, China. Electronic address: chenxu@swu.edu.cn.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173015']
1802,32835895,A twelve-month follow-up of an information communication technology delivered intervention for children with autism spectrum disorder living in regional Australia.,"This study investigated the long-term follow-up of an information communication techonology based intervention, the Therapeutic Outcomes By You application, for children with autism spectrum disorder living in regional Australia. Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes By You were assessed at least 12 months post-intervention to determine the maintenance or continued improvement of their language and social communication skills. Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.",2020,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","['Fifteen participants who completed a three-month randomised controlled trial of the Therapeutic Outcomes', 'children with autism spectrum disorder living in regional Australia']",[],"['receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]",15.0,0.0425543,"Findings demonstrate the receptive language, social skills, pragmatic language and playfulness of children with autism spectrum disorder improved during the three-month intervention period and were maintained at least 12 months after ceasing the Therapeutic Outcomes By You app intervention.","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Parsons', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia. Electronic address: dave.parsons@curtin.edu.au.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Vaz', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Hoe', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Kids are Kids!, Australia.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy, Social Work, and Speech Pathology, Curtin University, Kent St., Bentley, Western Australia, 6102 Perth, Australia; Department of Social Work, Education and Community Wellbeing, Northumbria University, Newcastle upon Tyne, United Kingdom.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103743']
1803,32841683,"Oral administration of porcine liver decomposition product for 4 weeks enhances visual memory and delayed recall in healthy adults over 40 years of age: A randomized, double-blind, placebo-controlled study.","BACKGROUND AND OBJECTIVES


Porcine liver decomposition product (PLDP) contains neurofunctional phospholipids. We previously reported that PLDP enhances cognitive function in healthy adult humans, based on clinical evaluations using Hasegawa's Dementia Scale-Revised. In this study, we evaluated the effect of PLDP on memory indicators of the Wechsler Memory Scale-Revised (WMS-R), an internationally recognized battery for memory assessment.
METHODS


We conducted a double-blind parallel-group placebo-controlled trial to evaluate the effect of PLDP on memory. Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the placebo group. Each group was administered PLDP (4 capsules) or a placebo (4 capsules) for 4 continuous weeks. WMS-R was administered before and 4 weeks after PLDP or placebo intake. The data were also subdivided by age for participants under 40 years (N = 15 in PLDP; N = 15 in placebo) and over 40 years (N = 13 in PLDP, N = 15 in placebo). Changes in Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall were analyzed.
RESULTS


No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age. However, for participants over 40 years of age, PLDP administration resulted in a significant enhancement than placebo administration in Delayed Recall (14.1 ± 7.1 points vs. 7.1 ± 6.8 points) (P < 0.05), Visual Recall I (20.1 ± 23.1 percentile vs 1.9 ± 22.8 percentile) (P < 0.05), and Visual Recall II (24.2 ± 25.8 percentile vs 6.7 ± 19.0 percentile) (P < 0.05), respectively. The composition ratio of men to women in each group was imbalanced but no significant difference existed between the two groups.
LIMITATIONS


A modest sample size, single-center design, and a fairly short follow-up period.
CONCLUSION


PLDP enhanced Visual Memory and Delayed Recall in healthy adults over 40 years of age but not in healthy adults under 40 years of age. Therefore, PLDP may represent a promising nutraceutical that could improve cognitive function in healthy adults over 40 years of age. Further studies are required to evaluate if long term PLDP administration can prevent or delay cognitive dysfunction in healthy adults over 40 years of age.",2020,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"['Fifty-eight participants competed the trial: 28 participants were in the PLDP group and 30 participants were in the', 'healthy adults over 40\u202fyears of age', 'healthy adult humans', 'participants under 40\u202fyears (N\u202f=\u202f15 in PLDP; N\u202f=\u202f15 in placebo) and over 40\u202fyears (N\u202f=\u202f13 in PLDP, N\u202f=\u202f15 in', 'healthy adults over 40\u202fyears of age but not in healthy adults under 40\u202fyears of age']","['PLDP', 'placebo', 'porcine liver decomposition product']","['Verbal Memory, Visual Memory, Attention/Concentration, and Delayed Recall', 'Visual Recall I', 'Visual Memory and Delayed Recall', 'cognitive function', 'memory indicators of the Wechsler Memory Scale-Revised (WMS-R', 'visual memory and delayed recall', 'composition ratio', 'Visual Recall', 'memory indicators', 'Delayed Recall']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",28.0,0.574256,No significant differences were found in any memory indicators between the PLDP group and the placebo group in pooled participants and in participants under 40 years of age.,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan. Electronic address: yomatsuda@nichiyaku.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Haniu', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Tsukahara', 'Affiliation': 'Department of Pharmacology and Therapeutic Innovation, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki 852-8521, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Uemura', 'Affiliation': 'Institute for Biomedical Sciences, Interdisciplinary Cluster for Cutting Edge Research, Shinshu University, Matsumoto 390-8621, Japan; Division of Gene Research, Research Center for Supports to Advanced Science, Shinshu University, Matsumoto 390-8621, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Sako', 'Affiliation': 'Division of Clinical Pharmacology and Pharmaceutics, Nihon Pharmaceutical University, Ina 362-0806, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kojima', 'Affiliation': 'Medical and Health Resources Research Institute, Tokyo 170-0013, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Mori Neurosurgery Clinic, Tokyo 142-0053, Japan.'}, {'ForeName': 'Kazusaburou', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Sugar Lady Cosmetics Co., Ltd, Tokyo 107-6011, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111064']
1804,32842249,[Effects of double-catheter epidural analgesia by lidocaine injection respectively on the delivery outcomes and maternal-infant complications for persistent posterior or lateral occipital position of protracted active phase].,"Objective:  To evaluate the effect of dual-tube epidural segmental injection of lidocaine analgesia on the delivery outcome and maternal and infant complications of persistent posterior occipital position postpartum or lateral occipital position postpartum patients with protracted active phase.  Methods:  The full and single-term primiparas ( n =216, 37 to 42 weeks gestation, 22 to 35 years) diagnosed as persistent posterior or lateral occipital position during the active period were selected from the Department of Obstetrics of Qingdao Municipal Hospital from January 2015 to October 2019. The subjects were randomly assigned into two groups: double-tube epidural block group ( n =108) and single-tube epidural block group ( n =108), 1% lidocaine was used for epidural analgesia respectively under ultrasound guidance. Senior midwife or obstetricians implement new partogram, and guide women to perform position management, and push or rotate the fetal head in a timely manner. Observation indicators: general condition, the use of non-pharmacological analgesic measures, analgesia related conditions and pain visual analogue scale (VAS) score, delivery-related indicator, cesarean section indication, anesthesia-related indicator, maternal and child complications.  Results:  (1) General condition: the age, weight, height, gestational age, the ratio of persistent lateral or posterior occipital position, cephalic score, and neonatal birth weight between the two groups of women were not statistically significant (all  P >0.05). (2) The use of non-pharmacological analgesic measures: the women's Lamaze breathing method, Doula delivery companionship, percutaneous electrical stimulation, and other measures between two groups were compared, and there were not significant differences (all  P >0.05). (3) Analgesia related conditions and VAS scores of women undergoing vaginal delivery: compared with the single-tube epidural block group ( n =40), the second-partum time of the women in the double-tube epidural block group ( n =59) was significantly shortened [(124±44) vs (86±33) minutes,  P <0.01]; after 30 minutes of analgesia (4.4±0.5 vs 0.9±0.5,  P <0.01), during forced labor in the second stage of labor (5.7±0.6 vs 1.3±0.4,  P <0.01), the VAS scores of pain were also significantly reduced ( P <0.01). (4) Labor-related indicators: compared with the single-tube epidural block group, the natural delivery rate (21.3% vs 49.1%) and the delivery experience satisfaction rate (51.9% vs 98.1%) of women in the double-tube epidural block group were significantly increased (all  P <0.01), cesarean section rate (63.0% vs 45.4%), instrument assisted rate (15.7% vs 5.6%) decreased significantly (all  P <0.05). (5) Cesarean section indications: compared with the single-tube epidural block group, the cesarean section rate caused by prolonged labor or protracted active phase of women in the double-tube epidural block group was significantly reduced (38.0% vs 22.2%；  P <0.05), and the fetal distress, intrauterine infection, and social factors caused by cesarean section between the two groups were compared, while the differences were not statistically significant (all  P >0.05).(6) Anesthesia related indexes: the block planes of the maternal upper tube administration in the double-tube epidural block group were mostly T7, T8, T9-L2 and L3,While,the block planes in the single-tube epidural block group were mostly T10, T11-S1, S2, S3, and the modified Bromage score were all 0. (7) Maternal and child complications: compared with the single-tube epidural block group, the postpartum hemorrhage rate (18.5% vs 7.4%), the perineal lateral cut rate (20.4% vs 5.6%), the neonatal asphyxia rate (12.0% vs 3.7%), ICU rate of transferred neonates (13.9% vs 4.6%) in the double-tube epidural block group were significantly reduced (all  P <0.05). Soft birth canal injury rate, puerperal disease rate and neonatal birth rate between two groups were compared, and there were not statistically significant differences (all  P >0.05).  Conclusion:  Dual-tube epidural segmental injection of lidocaine analgesia could increase the natural delivery rate of women with posterior occipital or lateral occipital position with active stagnation, reduce the rate of cesarean section and the rate of transvaginal instruments, and reduce the complications of mother and child.",2020,"Dual-tube epidural segmental injection of lidocaine analgesia could increase the natural delivery rate of women with posterior occipital or lateral occipital position with active stagnation, reduce the rate of cesarean section and the rate of transvaginal instruments, and reduce the complications of mother and child.","['women undergoing vaginal delivery', 'persistent posterior occipital position postpartum or lateral occipital position postpartum patients with protracted active phase', '37 to 42 weeks gestation, 22 to 35 years) diagnosed as persistent posterior or lateral occipital position during the active period were selected from the Department of Obstetrics of Qingdao Municipal Hospital from January 2015 to October 2019', 'women with posterior occipital or lateral occipital position with active stagnation']","['lidocaine analgesia', 'epidural analgesia respectively under ultrasound guidance', 'double-tube epidural block group', 'double-catheter epidural analgesia', 'lidocaine']","['delivery outcomes and maternal-infant complications', 'natural delivery rate', 'fetal distress, intrauterine infection, and social factors caused by cesarean section', '3) Analgesia related conditions and VAS scores', 'postpartum hemorrhage rate', 'perineal lateral cut rate', 'ratio of persistent lateral or posterior occipital position, cephalic score, and neonatal birth weight', 'ICU rate of transferred neonates', 'cesarean section rate caused by prolonged labor or protracted active phase', 'cesarean section rate', 'rate of cesarean section', 'delivery experience satisfaction rate', 'analgesia related conditions and pain visual analogue scale (VAS) score, delivery-related indicator, cesarean section indication, anesthesia-related indicator, maternal and child complications', 'VAS scores of pain', 'instrument assisted rate', 'Maternal and child complications', 'neonatal asphyxia rate', 'Soft birth canal injury rate, puerperal disease rate and neonatal birth rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0020013', 'cui_str': 'Municipal Hospitals'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring fetal status'}, {'cui': 'C1112157', 'cui_str': 'Intrauterine infection'}, {'cui': 'C0337460', 'cui_str': 'Social factor'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0004045', 'cui_str': 'Asphyxia, in liveborn infant'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}]",,0.0559332,"Dual-tube epidural segmental injection of lidocaine analgesia could increase the natural delivery rate of women with posterior occipital or lateral occipital position with active stagnation, reduce the rate of cesarean section and the rate of transvaginal instruments, and reduce the complications of mother and child.","[{'ForeName': 'J Z', 'Initials': 'JZ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'X Z', 'Initials': 'XZ', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Qingdao University, Qingdao 266000, China.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Qingdao University, Qingdao 266000, China.'}, {'ForeName': 'L P', 'Initials': 'LP', 'LastName': 'Kang', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Ji', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao 266071, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Department of Obstetrics, Qingdao Municipal Hospital, Qingdao 266071, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20191228-00705']
1805,32843370,Pansomatostatin Agonist Pasireotide Long-Acting Release for Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement: A Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVES


We assessed safety and efficacy of another somatostatin receptor analog, pasireotide long-acting release, in severe polycystic liver disease and autosomal dominant polycystic kidney disease. Pasireotide long-acting release, with its broader binding profile and higher affinity to known somatostatin receptors, has potential for greater efficacy.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Individuals with severe polycystic liver disease were assigned in a 2:1 ratio in a 1-year, double-blind, randomized trial to receive pasireotide long-acting release or placebo. Primary outcome was change in total liver volume; secondary outcomes were change in total kidney volume, eGFR, and quality of life.
RESULTS


Of 48 subjects randomized, 41 completed total liver volume measurements ( n =29 pasireotide long-acting release and  n =12 placebo). From baseline, there were -99±189 ml/m absolute and -3%±7% change in annualized change in height-adjusted total liver volume (from 2582±1381 to 2479±1317 ml/m) in the pasireotide long-acting release group compared with 136±117 ml/m absolute and 6%±7% increase (from 2387±759 to 2533±770 ml/m) in placebo ( P <0.001 for both). Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21 ml/m and 4%±5% increase in the placebo group ( P =0.05 for both). Changes in eGFR were similar between groups. Among the  n =48 randomized, adverse events included hyperglycemia (26 of 33 [79%] in pasireotide long-acting release versus four of 15 [27%] in the placebo group;  P <0.001), and among the 47 without diabetes at baseline, 19 of 32 (59%) in the pasireotide long-acting release group versus one of 15 (7%) in the placebo group developed diabetes ( P =0.001).
CONCLUSIONS


Another somatostatin analog, pasireotide long-acting release, slowed progressive increase in both total liver volume/total kidney volume growth rates without affecting GFR decline. Participants experienced higher frequency of adverse events (hyperglycemia and diabetes).
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Pasireotide LAR in Severe Polycystic Liver Disease, NCT01670110 PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2020_08_28_CJN13661119.mp3.",2020,Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21,"['48 subjects randomized, 41 completed total liver volume measurements ( n =29 pasireotide long-acting release and  n =12', 'Individuals with severe polycystic liver disease', 'severe polycystic liver disease and autosomal dominant polycystic kidney disease', 'Patients with Autosomal Dominant Polycystic Kidney or Liver Disease with Severe Liver Involvement']","['placebo', 'pasireotide long-acting release or placebo']","['Total kidney volumes', 'total kidney volume, eGFR, and quality of life', 'height-adjusted total liver volume', 'hyperglycemia', 'pasireotide long-acting release', 'change in total liver volume', 'frequency of adverse events (hyperglycemia and diabetes', 'Changes in eGFR']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0158683', 'cui_str': 'Congenital cystic disease of liver'}, {'cui': 'C0085413', 'cui_str': 'Autosomal dominant polycystic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1872203', 'cui_str': 'pasireotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",48.0,0.527677,Total kidney volumes decreased by -12±34 ml/m and -1%±4% in pasireotide long-acting release compared with 21±21,"[{'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Hogan', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota hogan.marie@mayo.edu.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Chamberlin', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Vaughan', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Waits', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Banks', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Leistikow', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Oftsie', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Chuck', 'Initials': 'C', 'LastName': 'Madsen', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Edwards', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Glockner', 'Affiliation': 'Department of Radiology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Walter K', 'Initials': 'WK', 'LastName': 'Kremers', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Harris', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'LaRusso', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Vicente E', 'Initials': 'VE', 'LastName': 'Torres', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'Tatyana V', 'Initials': 'TV', 'LastName': 'Masyuk', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13661119']
1806,32851483,Acute effects of inspiratory muscle training at different intensities in healthy young people.,"BACKGROUND


Understanding the acute effects of inspiratory muscle training (IMT) at different intensities on the autonomic nervous system, arterial stiffness, and blood pressure in healthy young people will be important in the constitution of appropriate IMT prescriptions.
AIMS


To investigate the acute effects of IMT at different intensities on autonomic function, arterial stiffness, and blood pressure in healthy young people METHODS: Thirty-six healthy participants were enrolled in this crossover study. All participants randomly performed IMT sessions, which consisted of diaphragmatic breathing exercise (DBE), 10%, 30%, and 60% of maximal inspiratory pressure (MIP) on consecutive days. Autonomic function and arterial stiffness were assessed by measuring heart rate variability (HRV) and aortic pulse wave velocity (AoPWV), respectively. HRV, AoPWV, and blood pressure were recorded before and immediately after each IMT session.
RESULTS


There was no significant difference in the baseline measurements between IMT sessions (p > 0.05). Heart rate (HR) significantly decreased after DBE and IMT at 10% of MIP (p < 0.05). All time domain parameters of HRV significantly improved after DBE compared with the baseline (p < 0.05). There was no difference in the frequency domain of HRV after the IMT sessions (p > 0.05). AoPWV significantly increased after IMT at 60% of MIP (p < 0.05). Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05).
CONCLUSIONS


A single session of DBE positively affects autonomic function and blood pressure, while IMT at 60% of MIP increases arterial stiffness. The different intensities of IMT have various impacts on autonomic function, arterial stiffness, and blood pressure.
TRIAL REGISTRATION


NCT03788356.",2020,"Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05).
","['healthy young people METHODS', 'healthy young people', 'Thirty-six healthy participants']","['IMT', 'maximal inspiratory pressure (MIP', 'diaphragmatic breathing exercise (DBE', 'inspiratory muscle training (IMT', 'inspiratory muscle training']","['HRV, AoPWV, and blood pressure', 'frequency domain of HRV', 'autonomic function, arterial stiffness, and blood pressure', 'Autonomic function and arterial stiffness', 'autonomic function and blood pressure', 'Heart rate (HR', 'Mean arterial pressure', 'AoPWV', 'heart rate variability (HRV) and aortic pulse wave velocity (AoPWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",36.0,0.0436921,"Mean arterial pressure significantly changed after DBE and IMT at 60% of MIP (p < 0.05).
","[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Tanriverdi', 'Affiliation': 'Graduate School of Health Sciences, Dokuz Eylül University, Izmir, Turkey. tanrverdiaylin@gmail.com.'}, {'ForeName': 'Buse Ozcan', 'Initials': 'BO', 'LastName': 'Kahraman', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ozsoy', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Ozpelit', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}]",Irish journal of medical science,['10.1007/s11845-020-02353-w']
1807,32851513,Desflurane and sevoflurane concentrations in blood passing through the oxygenator during cardiopulmonary bypass: a randomized prospective pilot study.,"PURPOSE


Volatile anesthetics (VAs) protect myocardial cells in cardiovascular surgery. A recent clinical trial of cardiopulmonary bypass (CPB) surgery reported no significant difference in mortality rates between the use of VAs and total intravenous anesthetics at 1 year postoperatively. However, oxygenator function may affect the VA pharmacokinetics. Thus, we measured the VA blood concentrations during CPB in patients managed with four different microporous polypropylene hollow fiber membrane oxygenators.
METHODS


Twenty-four patients scheduled for elective CPB were randomly allocated to one of the two VA groups (desflurane and sevoflurane groups) and, then, randomly divided into one of four oxygenator groups: Terumo, LivaNova, Medtronic, and Senko (n = 3). Additionally, in each VA group, three patients were randomly selected and redundantly allocated to the human lung group (for control blood VA concentration without oxygenator). Blood samples collected 20 min after starting 6.0 vol% desflurane or 1.7 vol% sevoflurane were analyzed using gas chromatography. Oxygenator-related complications and structural changes in the membrane surface of each oxygenator after surgery were evaluated.
RESULTS


The mean (standard deviation) concentrations of desflurane and sevoflurane in the human lung were 182.4 (23.2) and 54.0 (9.6) μg/ml, respectively; not significantly different from those in the four oxygenator groups. No oxygenator-related complications occurred. Structural changes in membrane fibers did not occur after clinical use, except for difficulty in image acquisition with Senko products.
CONCLUSION


Our results demonstrated that the blood concentrations of desflurane and sevoflurane passing through oxygenators used during CPB were similar to those in the human lung control.",2020,No oxygenator-related complications occurred.,"['patients managed with four different microporous polypropylene hollow fiber membrane oxygenators', 'Twenty-four patients scheduled for elective CPB', 'blood passing through the oxygenator during cardiopulmonary bypass']","['VA groups (desflurane and sevoflurane', 'LivaNova, Medtronic, and Senko', 'desflurane or 1.7 vol% sevoflurane', 'human lung group (for control blood VA concentration without oxygenator', 'Desflurane', 'Volatile anesthetics (VAs', 'cardiopulmonary bypass (CPB) surgery']","['VA blood concentrations', 'blood concentrations', 'mortality rates', 'mean (standard deviation) concentrations of desflurane and sevoflurane']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0032582', 'cui_str': 'Polypropylene'}, {'cui': 'C0475405', 'cui_str': 'Hollow fiber membrane'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]",24.0,0.0610064,No oxygenator-related complications occurred.,"[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan. takahiro@med.nagoya-u.ac.jp.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mori', 'Affiliation': 'Department of Perioperative Management System, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ishii', 'Affiliation': 'Department of Legal Medicine and Bioethics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kubo', 'Affiliation': 'Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-Ku, Nagoya, 466-8550, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02844-1']
1808,32853703,Double-Blind Placebo-Controlled Randomized Clinical Trial of Neurofeedback for Attention-Deficit/Hyperactivity Disorder With 13 Month Follow-up.,"OBJECTIVE


To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.
METHOD


In a 2-site double-blind randomized clinical trial, 144 children age 7-10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)>4.5 were randomized 3:2 to deliberate TBR downtraining vs. a control of equal duration, intensity, and appearance. Two early dropouts left 142 for modified intent-to-treat analysis. The control utilized pre-recorded EEGs with participant's artifacts superimposed. Treatment was programmed via internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists, 93.2% by NF expert monitor. Primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated.
RESULTS


Blinding was excellent. While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up). Responders (CGI-I=1-2) were 61% of NF and 54% of Controls (p=.36). Adverse events were distributed proportionally between treatments. 13-month follow-up found nonsignificant improvement from treatment end for NF (d=0.1), with mild deterioration for controls (d= -0.07). NF required significantly less medication at follow-up (p=.012).
CONCLUSION


This study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.",2020,"While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up).","['144 children age 7-10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)>4.5', 'Attention-Deficit/Hyperactivity Disorder']","['deliberate TBR', 'Neurofeedback', 'theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF', 'Placebo', 'deliberate TBR NF']","['parent- and teacher-rated inattention; analysis', 'Adverse events', 'Fidelity']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",144.0,0.256558,"While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.07.906']
1809,32854060,Anti-caries effect of fluoridated milk-based drink consumed by older adults on an in vitro root caries experimental model.,"OBJECTIVE


This study aimed to evaluate the anti-caries effect of a fluoridated milk-based drink on a root caries model by assessing mineral loss and both biofilm microbial viability and acidogenicity under increasing concentrations of fluoride supplementation.
DESIGN


Streptococcus mutans UA159 biofilms were grown on root dentin slabs for five days. The slabs were randomly assigned to following groups: milk-based drink (G1) and milk-based drink supplemented with 5-ppm NaF (G2), 10 ppm NaF (G3), and 20 ppm NaF (G4). A 10% sucrose and 0.9% NaCl solution were used as positive and negative-caries controls, respectively. Slabs/biofilms were exposed to the different treatments 3 times/day for 5 min. To estimate biofilm acidogenicity, the pH of the spent media was serially measured to calculate the area above the curve. Viable bacteria and dentin demineralization were assessed after the experimental phase. Results were compared using ANOVA followed by the Tukey test.
RESULTS


G1 exhibited slightly lower acidogenicity than the positive caries control group (p < 0.05). G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink. The lowest acidogenicity was found in G4 (p < 0.05). Fluoride-supplemented milk-based drinks (G2, G3, and G4) resulted in lower bacterial counts (p < 0.05) and induced lower demineralization (p < 0.05) than the positive caries control and non-supplemented milk-beverage (G1). There was a dose-dependent inhibition of demineralization with fluoride-supplemented milk-based drinks.
CONCLUSIONS


Fluoride supplementation of a milk-based drink for older adults may reduce its cariogenicity in root dentin.",2020,"G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink.","['older adults on an in vitro root caries experimental model', 'older adults']","['Fluoride supplementation', 'Fluoride-supplemented milk-based drinks (G2, G3, and G4', 'fluoridated milk-based drink', 'milk-based drink (G1) and milk-based drink supplemented with 5-ppm NaF (G2), 10\u202fppm NaF (G3), and 20\u202fppm NaF (G4']","['lower bacterial counts', 'Viable bacteria and dentin demineralization', 'acidogenicity', 'lowest acidogenicity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0162644', 'cui_str': 'Root caries'}, {'cui': 'C0086272', 'cui_str': 'Experimental Models'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3541971', 'cui_str': 'Fluoride supplement'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}]",,0.0182389,"G2, G3, and G4 induced lower acidogenicity than 10% sucrose and the non-supplemented milk-based drink.","[{'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Castro', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation and Health Sciences Faculty, School of Dentistry, University of Talca, 1 Poniente 1141, Talca, Chile.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maltz', 'Affiliation': 'Preventive and Community Dentistry Department, Dental School, Federal University of Rio Grande do Sul (UFRGS), Rua Ramiro Barcelos 2492, Porto Alegre, Brazil. Electronic address: marisa.maltz@gmail.com.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Arthur', 'Affiliation': 'Preventive and Community Dentistry Department, Dental School, Federal University of Rio Grande do Sul (UFRGS), Rua Ramiro Barcelos 2492, Porto Alegre, Brazil.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Giacaman', 'Affiliation': 'Cariology Unit, Department of Oral Rehabilitation and Health Sciences Faculty, School of Dentistry, University of Talca, 1 Poniente 1141, Talca, Chile.'}]",Archives of oral biology,['10.1016/j.archoralbio.2020.104878']
1810,32854153,Integrating high-intensity interval training into the workplace: The Work-HIIT pilot RCT.,"The purpose of this study was to assess the feasibility and preliminary efficacy of a high-intensity interval training (HIIT) intervention integrated into the workplace on physical and mental health outcomes in a sample of adults. The Work-HIIT intervention was evaluated at the University of Newcastle (March-July 2019). University employees (18+ years) who self-identified as predominantly sedentary at work (n = 47, 43.0 ± 10.7 years; 41 female) were recruited, screened, and randomized after baseline assessments into Work-HIIT (n = 24) or wait-list control (n = 23) conditions. Participants were asked to attend 2-3 researcher-facilitated HIIT sessions/week (weeks 1-8). Sessions included a 2-minute gross-motor warm-up, followed by various combinations of aerobic and muscular fitness exercises lasting 8 minutes (using 30:30 second work: rest intervals). Program feasibility was assessed using measures of satisfaction, compliance, adherence, fidelity, and retention. Physiological and psychological outcomes were measured at baseline and 9 weeks. Feasibility data were investigated using descriptive statistics and efficacy outcomes determined using linear mixed models and Cohen's d effect sizes. Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/wk and averaged 85.9% HR max  across all sessions (including rest and work intervals). Small-to-medium positive effects resulted for cardiorespiratory fitness [+2.9 laps, 95% CI (-4.19-10.14); d = 0.34] and work productivity [+0.26, d = 0.47]. Large positive effects resulted for muscular fitness [push-ups +3.5, d = 0.95; standing jump +10.1 cm, d = 1.12]; HIIT self-efficacy [+16.53, d = 1.57]; sleep [weekday +0.76 hours, d = 1.05]; and autonomous motivation [+0.23, d = 0.76]. This study supports the feasibility and preliminary efficacy of facilitator-led Work-HIIT as a time-efficient, enjoyable, and convenient workplace exercise option for adults.",2020,Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max  across all sessions (including rest and work intervals).,"['adults', 'a sample of adults', 'University employees (18+yrs) who self-identified as predominantly sedentary at work (n=47, 43.0 ± 10.7yrs; 41 female']","['wait-list control', 'high intensity interval training (HIIT) intervention', 'facilitator-led Work-HIIT', '2-minute gross-motor warm-up, followed by various combinations of aerobic and muscular fitness exercises lasting 8-minutes']","['cardio-respiratory fitness', 'physical and mental health outcomes', 'satisfaction, compliance, adherence, fidelity, and retention', 'muscular fitness', 'Physiological and psychological outcomes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3540029', 'cui_str': 'various combinations'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.0516742,Participant ratings showed high levels of satisfaction (4.6/5); 71% of participants attended ≥2 sessions/week and averaged 85.9%HR max  across all sessions (including rest and work intervals).,"[{'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Eather', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Babic', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Riley', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Harris', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'University of British Columbia, Callaghan, BC, Canada.'}, {'ForeName': 'Mikeelie', 'Initials': 'M', 'LastName': 'Jeffs', 'Affiliation': 'Faculty of Education and Arts, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Barclay', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13811']
1811,32857732,Multi-walled carbon nanotubes functionalized with pyrene-PEG via π-π interactions: toxicological assessment in zebrafish embryos.,"Multi-walled carbon nanotubes (MWCNT) have many promising biological applications, even though functionalization is needed for better biocompatibility. Functionalization of MWCNT with polyethylene glycol (PEG) is a promising and widely studied approach, but the best PEGylation method is still under investigation. In this work, we have tested the biological implications of MWCNT functionalized via π-stacking with pyrene-PEG (MWCNT-Pyr-PEG) in zebrafish embryos. As Pyr toxicity is well documented and represents a major concern for the safety of the proposed approach, we have also tested the effects of the exposure to the isolated conjugate (Pyr-PEG). The resulting suspensions were stable in saline medium and well dispersed. Zebrafish embryos at 24 h post-fertilization (hpf) were dechorionated and randomly assigned to seven experimental groups (n = 50 per group): control, MWCNT-Pyr-PEG at 0.2, 2.0, and 20.0 mg l -1 , and Pyr-PEG at the same concentrations, and exposures were performed in 96-well plates. Specimens were observed for heart rate, malformations, body length, mortality, traveled distance, and number of new movements. Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l -1 . The highest concentration of MWCNT-Pyr-PEG also led to increased occurrence of malformations, shortened body length and reduced traveled distance. The functionalization approach shows promise due to the stability in saline media, even though toxic effects were observed in the highest tested concentrations, being the MWCNT the main actors underlying these outcomes.",2020,"Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l -1 .",['zebrafish embryos'],"['MWCNT with polyethylene glycol (PEG', 'Multi-walled carbon nanotubes (MWCNT', 'control, MWCNT-Pyr-PEG']","['heart rate, malformations, body length, mortality, traveled distance, and number of new movements', 'Heart rate', 'occurrence of malformations, shortened body length and reduced traveled distance', 'toxic effects']","[{'cui': 'C0043457', 'cui_str': 'Zebrafishes'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1138408', 'cui_str': 'Carbon Nanotubes'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.0305508,"Heart rate was reduced in embryos exposed to any tested concentration of MWCNT-Pyr-PEG, while this effect was observed with Pyr-PEG from 2 mg l -1 .","[{'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Cordeiro', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Saúde (PPGBS), Universidade do Oeste de Santa Catarina (UNOESC), Joaçaba, SC, Brazil. Programa de Pós-Graduação em Ciências Fisiológicas (PPGCF), Universidade Federal do Rio Grande (FURG), Rio Grande, RS, Brazil.'}, {'ForeName': 'Lívia S', 'Initials': 'LS', 'LastName': 'Gomides', 'Affiliation': ''}, {'ForeName': 'Camila O', 'Initials': 'CO', 'LastName': 'Vian', 'Affiliation': ''}, {'ForeName': 'Marina T', 'Initials': 'MT', 'LastName': 'Carboni', 'Affiliation': ''}, {'ForeName': 'Adelina P', 'Initials': 'AP', 'LastName': 'Santos', 'Affiliation': ''}, {'ForeName': 'Gisele Eva', 'Initials': 'GE', 'LastName': 'Bruch', 'Affiliation': ''}, {'ForeName': 'Ana Paula', 'Initials': 'AP', 'LastName': 'Horn', 'Affiliation': ''}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Barros', 'Affiliation': ''}]",Nanotechnology,['10.1088/1361-6528/abae2f']
1812,32840955,Video cognitive-behavioral therapy for insomnia in cancer patients: A cost-effective alternative.,"OBJECTIVE


Despite its high prevalence, cancer-related insomnia typically remains untreated because of a lack of access to cognitive-behavioral therapy for insomnia (CBT-I), the treatment of choice for this condition. While face-to-face CBT-I appears to be optimal in terms of efficacy, self-administered formats may be more cost-effective. The goal of this secondary analysis of a randomized clinical trial was to compare the cost-effectiveness of a professionally-based CBT-I (PCBT-I) to that of a video-based CBT-I (VCBT-I).
METHODS


A total of 161 women with breast cancer received six weekly, individual CBT-I sessions (PCBT-I; n = 81) or a 60-minutes animated video +6 short booklets (VCBT-I; n = 80). Participants completed the Insomnia Severity Index (ISI) and provided information to calculate treatment costs.
RESULTS


Total per patient treatment costs were 5.5 times greater for PCBT-I ($1298.90) than VCBT-I ($234.36; P < .0001). Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT-I than VCBT-I, but these differences were not significant (P = .09 and P = .24, respectively). In contrast, the cost-effectiveness ratio was significantly more advantageous for VCBT-I than PCBT-I. Compared to VCBT-I, each reduction of 1 unit on the ISI produced by PCBT-I was associated with a treatment cost that was significantly greater at posttreatment ($186.95 CAD vs $44.87 CAD; P = .001) and follow-up ($154.76 vs $24.97, P = .005).
CONCLUSIONS


Although CBT-I is slightly less efficacious when self-administered, it constitutes a much more cost-effective alternative than face-to-face CBT-I and represents an extremely valuable option in settings where monetary and human resources required to administer CBT-I are not available or sufficient.",2020,"Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT","['161 women with breast cancer', 'Cancer Patients ']","['individual CBT-I sessions (PCBT-I; n =\u200981) or a 60-min animated video + 6 short booklets', 'professionally-based CBT-I (PCBT-I', 'PCBT', 'Video Cognitive-Behavioral Therapy', 'video-based CBT-I (VCBT-I']","['Insomnia Severity Index (ISI', 'cost-effectiveness', 'cost-effectiveness ratio', 'ISI reduction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",161.0,0.0324276,"Both at posttreatment and 3-month follow-up, the ISI reduction was greater in PCBT","[{'ForeName': 'Josée', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'School of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ivers', 'Affiliation': 'School of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'School of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Economics, Université Laval, Quebec City, Quebec, Canada.'}]",Psycho-oncology,['10.1002/pon.5532']
1813,32835919,Effect of sweet fennel seed extract capsule on knee pain in women with knee osteoarthritis.,"BACKGROUND AND OBJECTIVES


Knee osteoarthritis is one of the most common types of arthritis. The disease not only has a high disease burden but also reduces the quality of life of patients. The purpose of this research was to study the effect of Foeniculum vulgare Mill. (commonly known as Fennel) seed extract on knee pain in women patients with knee osteoarthritis.
METHODS


In this randomized, double-blind trial, a total of 66 patients were assigned randomly via the blocking method in two groups, fennel and placebo. All patients received four capsules daily of either powdered fennel extract (each capsule contained 200 mg dried fennel extract from 7 g of fennel seeds) or placebo twice a day for two weeks. The patients completed the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Visual Analog Scale (VAS) for pain intensity measurement before and after the study completion. Data were then analyzed via intention to treat method using the SPSS statistical software package.
RESULTS


Two weeks after the trial, a significant decrease was noted between the two groups in terms of pain, disability, total WOMAC score, and VAS variables. After comparing the pre- and post-intervention, the variables mentioned above revealed a significant decline in both groups. The stiffness variable indicated a significant reduction in the fennel group (between baseline and study completion) after two weeks, but this decline was not significant in the placebo group, and was not significant either between the two groups. At the end of the trial, the percentage change was higher in the fennel group than in the placebo group. Also, the effect size was greater in the fennel group especially in pain variable based on WOMAC and VAS than in the placebo group.
CONCLUSION


The results indicated that fennel may be an appropriate alternative for complementary treatment in patients with knee osteoarthritis. This study is the first clinical trial using oral fennel on knee pain in these patients, and the outcomes should be confirmed through additional studies.",2020,", a significant decrease was noted between the two groups in terms of pain, disability, total WOMAC score, and VAS variables.","['66 patients', 'women patients with knee osteoarthritis', 'women with knee osteoarthritis', 'patients with knee osteoarthritis']","['powdered fennel extract', 'sweet fennel seed extract capsule', 'Foeniculum vulgare Mill', 'fennel and placebo', 'placebo', 'oral fennel', 'Fennel) seed extract']","['Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire and Visual Analog Scale (VAS) for pain intensity measurement', 'knee pain', 'pain variable based on WOMAC and VAS', 'effect size', 'pain, disability, total WOMAC score, and VAS variables']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0015833', 'cui_str': 'Fennel extract'}, {'cui': 'C0453256', 'cui_str': 'Fennel seed preparation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0553175', 'cui_str': 'Foeniculum vulgare'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",66.0,0.250297,", a significant decrease was noted between the two groups in terms of pain, disability, total WOMAC score, and VAS variables.","[{'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Alazadeh', 'Affiliation': 'Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran; Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: marziehalazadeh@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Azadbakht', 'Affiliation': 'Department of Pharmacognosy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Azadbakht110@gmail.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Niksolat', 'Affiliation': 'Orthopedic Research Center, Faculty of Medicine, Department of Internal Medicine, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Fniksolat@yahoo.com.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Asgarirad', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Dr_Asgarirad@yahoo.com.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Moosazadeh', 'Affiliation': 'Health Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: Mmoosazadeh1351@gmail.com.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: amirhossein_pharma@yahoo.com.'}, {'ForeName': 'Seyde Sedighe', 'Initials': 'SS', 'LastName': 'Yousefi', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran; Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran. Electronic address: s.yousefi@mazums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101219']
1814,32835925,Efficacy of donepezil for the attenuation of memory deficits associated with electroconvulsive therapy.,"We sought to confirm and extend the findings of studies that reported that acetylcholinesterase inhibitor drugs protect against electroconvulsive therapy (ECT)-induced cognitive impairment. We randomized 30 patients with depression (n=24) or schizophrenia (n=6) to receive either donepezil (10 mg/day; n=15) or placebo (n=15) during a fixed course of 6 thrice-weekly, modified, bifrontotemporal sine wave ECT, and for 30 days subsequently. We assessed memory using the Postgraduate Institute Memory Scale (PGI-MS) at baseline, and again at days 2, 7, and 30 after the ECT course. At baseline, memory functioning was comparable in the 2 groups. At 2 days post-ECT, memory functioning was impaired on almost all 10 subtests and on the total scale. At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself. There was no significant difference between groups in the primary outcome, improvement in PGI-MS scores between Days 2 and 30 post-ECT. On almost all subtests, also, there was no significant difference between groups. In summary, we found that donepezil (10 mg/day) did not improve memory outcomes after ECT.",2020,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.",['30 patients with depression (n=24) or schizophrenia (n=6) to receive either'],"['donepezil', 'placebo', 'electroconvulsive therapy']","['Postgraduate Institute Memory Scale (PGI-MS', 'memory outcomes', 'PGI-MS scores', 'memory functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.109804,"At 30 days post-ECT, memory functioning improved to (numerically) above baseline levels on almost all subtests and on the total scale, with the bulk of the improvement evident by day 7, itself.","[{'ForeName': 'Lt Col Bikram', 'Initials': 'LCB', 'LastName': 'Dutta', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India.'}, {'ForeName': 'Col Pradyot', 'Initials': 'CP', 'LastName': 'Sarkar', 'Affiliation': 'Ohio Hospital, New Town, Kolkata, India. Electronic address: colpsarkar@live.com.'}, {'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': 'Dean (Basic Sciences), Department of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore 560 029, India. Electronic address: andradec@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113397']
1815,32835958,Enhancing extinction with response prevention via imagery-based counterconditioning: Results on conditioned avoidance and distress.,"BACKGROUND AND OBJECTIVES


Maladaptive avoidance is a core characteristic of anxiety-related disorders. Its reduction is often promoted using extinction with response prevention (ExRP) procedures, but these effects are often short-lived. Research has shown that pairing a feared stimulus with a stimulus of an incompatible valence (i.e., counterconditioning) may be effective in reducing fear. This laboratory study tested whether positive imagery during ExRP (i.e., imagery counterconditioning protocol) can also reduce avoidance.
METHODS


In the counterconditioning procedure, participants imagined a positive sound. There were four phases. First, participants were presented with squares on a computer screen of which one (CS+) was paired with an aversive sound and another (CS-) was not. Second, they learned to avoid the negative sound in the presence of the CS+, via a key press. Third, they were assigned to either the Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP). Finally, they performed a test phase that consisted of two parts: in the first part, avoidance responses were available for each CS and in the second part, these responses were prevented.
RESULTS


The Counterconditioning intervention resulted in a short-lived reduction of distress associated with the CS+. However, groups did not differ in avoidance or distress during the test phases.
LIMITATIONS


US-expectancy ratings were collected only at the end of the experiment.
CONCLUSIONS


The results indicate that positive imagery during ExRP may be effective in reducing distress during the intervention. Explanations for the persistence of avoidance and fear are discussed.",2020,"However, groups did not differ in avoidance or distress during the test phases.
",[],['Counterconditioning (that was asked to imagine a positive sound during ExRP) or No Counterconditioning group (standard ExRP'],"['avoidance or distress', 'distress']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}]",,0.037803,"However, groups did not differ in avoidance or distress during the test phases.
","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Hendrikx', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}, {'ForeName': 'Angelos-Miltiadis', 'Initials': 'AM', 'LastName': 'Krypotos', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands; Department of Healthy Psychology, KU Leuven, Belgium. Electronic address: amkrypotos@gmail.com.'}, {'ForeName': 'Iris M', 'Initials': 'IM', 'LastName': 'Engelhard', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, the Netherlands.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101601']
1816,32836059,"No effect of feedback, level of processing or stimulus presentation protocol on perceptual learning when easy and difficult trials are interleaved.","The role of feedback during training is a topic of great theoretical importance in perceptual learning. Feedback can be provided externally by the environment or internally by the observer. In order to evaluate the effectiveness of learning with internal versus external feedback, we performed a large multi-level experiment, varying the type of training task (Motion or Form), the level of processing (Local or Global), the presence of feedback (With or Without) and finally the method of stimulus presentation (Adaptive staircase or Method of constant stimuli). 140 participants were randomly assigned to one of ten groups and undertook 3 days of training in one condition only. Detection thresholds were measured daily before and after training with a pre- and post-assessment. A 75% detection threshold was calculated and used to estimate that day's training levels (65% and 85% accuracy for difficult and easy trials respectively). The group trained with MOCS were presented with predefined randomly interleaved easy and difficult trials ranging from 50% to 95% stimulus intensity. Our findings indicate that improvement was generally robust across training-tasks, processing levels and feedback conditions. This suggests that internal reinforcement is as effective as external feedback in a discrete-noise-paradigm for local and global tasks when easy and difficult trials are interleaved.",2020,"Our findings indicate that improvement was generally robust across training-tasks, processing levels and feedback conditions.",['140 participants'],"['learning with internal versus external feedback', 'MOCS', 'training task (Motion or Form), the level of processing (Local or Global), the presence of feedback (With or Without) and finally the method of stimulus presentation (Adaptive staircase or Method of constant stimuli']",[],"[{'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1720529', 'cui_str': 'Constant'}]",[],140.0,0.0215408,"Our findings indicate that improvement was generally robust across training-tasks, processing levels and feedback conditions.","[{'ForeName': 'Jordi M', 'Initials': 'JM', 'LastName': 'Asher', 'Affiliation': 'Department of Psychology, University of Essex, United Kingdom. Electronic address: jashera@essex.ac.uk.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Hibbard', 'Affiliation': 'Department of Psychology, University of Essex, United Kingdom.'}]",Vision research,['10.1016/j.visres.2020.07.011']
1817,32836063,"Efficacy of scalp nerve blocks using ropivacaïne 0,75% associated with intravenous dexamethasone for postoperative pain relief in craniotomies.","Pain after supratentorial craniotomy is common, 55 % to 80 % of patients experience moderate to severe pain in the first 48 h(1-7). The importance of intravenous dexamethasone as an adjuvant to local anaesthetics is increasingly applied(1-7), however its role in scalp nerve blocks with ropivacaine 0.75 % remains unexplored in post-operative analgesia. We analyzed 134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with ropivacaine 0.75 %. The general anaesthesia was standardized and included 8 mg of intravenous dexamethasone at the induction. The postoperative pain was assessed using the numerical rating scale with patients in the post anaesthesia care unit and subsequently every 8 h in the neurosurgery unit until the 48th hour. A NRS value above 3 led to the administration of a rescue analgesic according to the defined protocol until an efficient analgesia was obtained. Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group. More than 60 % of the patients from the scalp nerve blocks group had an efficient analgesia without any rescue analgesic. Peroperatively the scalp nerve blocks group showed a decrease in opioid consumption and a better hemodynamic stability. No anesthetic or chirurgical complications related to the use of scalp blocks were observed. Scalp nerve blocks associated with intravenous dexamethasone are found to be a straightforward and efficient analgesic approach during supratentorial craniotomies.",2020,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","['134 supratentorial craniotomies under general anaesthesia, 46 of which had preoperatively bilateral scalp nerve blocks with', 'craniotomies']","['dexamethasone', 'ropivacaïne', 'ropivacaine']","['efficient analgesia without any rescue analgesic', 'postoperative pain relief', 'severe pain', 'hemodynamic stability', 'Postoperative pain', 'Pain', 'opioid consumption', 'postoperative pain']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",134.0,0.065171,"Postoperative pain was controlled in both groups, however the need for rescue analgesics in the scalp nerve blocks group was reduced by 40 % (39 % vs. 65 %; p = 0.006) compared to the control group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gaudray', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: eliott.gaudray@gmail.com.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': ""N' Guyen"", 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: cedric1.nguyen@intradef.gouv.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: edouard1.martin@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lyochon', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: arthur.lyochon@intradef.gouv.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dagain', 'Affiliation': 'Department of Neurosurgery, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: arnaud.dagain@intradef.gouv.fr.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bordes', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: julien.bordes@intradef.gouv.fr.'}, {'ForeName': 'P Y', 'Initials': 'PY', 'LastName': 'Cordier', 'Affiliation': 'Department of Anesthesiology, Laveran Military Teaching Hospital, Marseille, France. Electronic address: pierre-yves.cordier@intradef.gouv.fr.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Lacroix', 'Affiliation': 'Department of Anesthesiology, Saint-Anne Military Teaching Hospital, Toulon, France. Electronic address: guillaume.lacroix@intradef.gouv.fr.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106125']
1818,32841892,Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide.,"This study used a novel theory-informed latent class approach, based on the Interpersonal Psychological Theory of Suicide (IPTS), to identify subgroups of individuals with a suicide attempt history. The identification of subgroups can inform treatments that target these specific subgroups. Using data from a randomised controlled trial, latent class analysis was conducted on 227 adults with a suicide attempt history. Latent classes were identified based on suicide attempt history, perceived burdensomeness, thwarted belongingness, and capability for suicide at the trial baseline. Three classes were found. Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants). Class 1 had elevated suicidal ideation for the duration of the trial. Classes 1 and 2 also had elevated interpersonal risks relative to a population-based sample. These results suggest that some individuals with a suicide attempt history exhibit relatively low interpersonal risks, and given concurrent protective psychological factors, may be suited to low-intensity interventions. At the other extreme, some individuals with a suicide attempt history require high-intensity interventions addressing interpersonal risks, clinical symptoms, and protective psychological factors.",2020,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","['individuals with a suicide attempt history', 'Identifying subgroups within a sample of adults with a suicide attempt history using the Interpersonal Psychological Theory of Suicide', '227 adults with a suicide attempt history']",[],"['elevated suicidal ideation', 'interpersonal risks and clinical symptoms, and lower protective psychological factors']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033906', 'cui_str': 'Psychological Theories'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}]",227.0,0.0482775,"Classes 1 and 2 (80% of participants) at baseline had higher interpersonal risks and clinical symptoms, and lower protective psychological factors (e.g., positive reframing), compared to Class 3 (20% of participants).","[{'ForeName': 'Quincy J J', 'Initials': 'QJJ', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia; School of Psychology, Western Sydney University, Sydney, NSW, Australia. Electronic address: q.wong@westernsydney.edu.au.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Bregje A J', 'Initials': 'BAJ', 'LastName': 'van Spijker', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, NSW, Australia.'}]",Psychiatry research,['10.1016/j.psychres.2020.113406']
1819,32841904,Hyperarousal symptoms and perceived burdensomeness interact to predict suicidal ideation among trauma-exposed individuals.,"The association between posttraumatic stress disorder (PTSD) and suicidal ideation is well-established and recent prospective studies have demonstrated the unique role of hyperarousal symptoms. In particular, over-arousal may elevate suicide risk in the presence of interpersonal vulnerability factors including thwarted belongingness, perceived burdensomeness, and acquired capability. Therefore, the current study sought to examine the differential associations between PTSD symptom clusters and suicidality and the impact of interpersonal risk factors. Trauma-exposed adults (N = 247) completed a questionnaire battery at baseline and three-month follow-up, as part of a larger randomized controlled trial of computerized interventions for suicide risk. Given the focus of the current study, treatment condition was controlled for in all analyses. Results indicated that hyperarousal symptoms significantly predict suicidality, while reexperiencing and avoidance symptoms do not. Specifically, greater hyperarousal symptoms predicted increased suicidal ideation among individuals with high perceived burdensomeness. Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability. Taken together, findings suggest that assessment of hyperarousal symptoms and perceived burdensomeness may serve to identify trauma-exposed individuals at greater risk for suicide. Additionally, these factors may serve as effective intervention targets.",2020,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.",['Trauma-exposed adults (N\xa0=\xa0247) completed a'],['questionnaire battery at baseline and three-month follow-up'],"['hyperarousal symptoms', 'suicidal ideation', 'Hyperarousal symptoms']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C4552570', 'cui_str': 'Hyperarousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",247.0,0.0289762,"Although the interaction effect was not significant, hyperarousal symptoms were also pertinent among individuals with high acquired capability.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Morabito', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA. Electronic address: Morabito@psy.fsu.edu.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Boffa', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Carter E', 'Initials': 'CE', 'LastName': 'Bedford', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Jimmy P', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'Furman University, 3300 Poinsett Hwy, Greenville, SC, USA, 29613.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, 1107 W. Call Street, Tallahassee, FL, 32306, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.029']
1820,32845399,Pain after permanent versus delayed absorbable monofilament suture for vaginal graft attachment during minimally invasive total hysterectomy and sacrocolpopexy.,"OBJECTIVES


The objective was to evaluate pain and dyspareunia in women undergoing minimally invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh 1 year after surgery.
METHODS


This is a planned secondary analysis of a randomized trial comparing permanent (Gore-Tex) versus absorbable suture (PDS) for vaginal attachment of a y-mesh (Upsylon™) during TLH + SCP in women with stage ≥II prolapse. Patient data were collected at baseline and 1 year after surgery. Our primary outcome was patient-reported pain or dyspareunia at 1 year.
RESULTS


Two hundred subjects (Gore-Tex n = 99, PDS n = 101) were randomized and underwent surgery. Overall, the mean age ± SD was 60 ± 10 years, and BMI was 27 ± 5 kg/m 2 . The majority were white (89%), menopausal (77%), and had stage III/IV (63%) prolapse. 93% completed a 1-year follow-up and are included in this analysis (Gor-Tex n = 95, PDS n = 90). The overall rate of participants who reported pain at 1 year was 20%. Of those who did not report any pain at baseline, 23% reported de novo dyspareunia, 4% reported de novo pain, and 3% reported both at 1 year. Of participants who reported pain or dyspareunia at baseline prior to surgery, 66% reported resolution of their symptoms at 1 year. There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year. On multiple logistic regression controlling for age, baseline dyspareunia, and baseline pain, baseline dyspareunia was associated with a nearly 4-fold increased odds of reporting any pain at 1 year (OR 3.8, 95%CI 1.7-8.9).
CONCLUSIONS


The majority of women report resolution of pain 1 year following TLH + SCP with a low rate of de novo pain.",2020,"There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year.","['women with stage ≥II prolapse', 'women undergoing minimally invasive total hysterectomy and', 'Two hundred subjects (Gore-Tex n\u2009=\u200999, PDS n\u2009=\u2009101']","['permanent (Gore-Tex) versus absorbable suture (PDS', 'TLH\u2009+\u2009SCP', 'sacrocolpopexy (TLH\u2009+\u2009SCP) with a light-weight polypropylene mesh', 'delayed absorbable monofilament suture']","['mesh/suture exposure', 'patient-reported pain or dyspareunia', 'de novo dyspareunia', 'baseline dyspareunia, and baseline pain, baseline dyspareunia', 'de novo pain', 'overall rate of participants who reported pain', 'pain and dyspareunia', 'Pain', 'pain or dyspareunia', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018088', 'cui_str': 'Goretex'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0018088', 'cui_str': 'Goretex'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0271829', 'cui_str': ""Pendred's syndrome""}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy'}, {'cui': 'C0332264', 'cui_str': 'Light (weight)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh'}, {'cui': 'C1961537', 'cui_str': 'Monofilament suture'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",200.0,0.715988,"There were no differences in most characteristics, including mesh/suture exposure (7% vs 5%, p = 0.56) between patients who did and did not report any pain at 1 year.","[{'ForeName': 'C Emi', 'Initials': 'CE', 'LastName': 'Bretschneider', 'Affiliation': 'Northwestern Feinstein School of Medicine, 250 E. Superior St. Suite 5-2370, Chicago, IL, 60611, USA. carol.bretschneider@nm.org.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': 'Northwestern Feinstein School of Medicine, 250 E. Superior St. Suite 5-2370, Chicago, IL, 60611, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Geller', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Wu', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Matthews', 'Affiliation': 'Department of Urology, Wake Forest Baptist Health, Winston Salem, NC, USA.'}]",International urogynecology journal,['10.1007/s00192-020-04471-6']
1821,32846821,Effect and safety of intravenous versus oral acetaminophen after unicompartmental knee replacement: A protocol of randomized controlled study.,"BACKGROUND


Due to the soft tissue injury and large amount of bone destruction involved, undesirable postoperative pain remains a challenge for both patients and surgeons after unicompartmental knee replacement (UKR). However, there are no studies comparing the effectiveness of oral and intravenous acetaminophen as part of a standard multimodal perioperative pain regimen after UKR. Thus, this prospective randomized study was conducted to compare pain control outcomes with postoperative oral versus intravenous acetaminophen use in adults undergoing UKR.
METHODS


The institutional review board of the Traditional Chinese Medicine- western Medicine Hospital of Cangzhou approved the study protocol. This blinded and randomized study was carried out in accordance with the principles of the Helsinki Declaration. We included patients who were scheduled for UKR with an American Society of Anesthesiologists status of I to III, who were mentally competent, and who were able to give consent for enrolment in the study. Patients were randomly assigned on a 1:1 basis to receive either intravenous acetaminophen or oral acetaminophen. We ensured that the patients, care providers, and outcome assessors were blinded to the group assignment during the study period. Primary outcomes were postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score. Secondary outcomes included morphine consumption at 24, 48, and 72 hours after surgery, length of hospital stay, range of motion, daily ambulation distance, and adverse events occurrence. All statistical analyses were performed using SPSS 25.0. Differences associated with a P value of <.05 were considered statistically significant.
RESULTS


It was hypothesized that patients receiving intravenous acetaminophen would exhibit similar postoperative outcomes compared with patients receiving oral acetaminophen.
TRIAL REGISTRATION


This study was registered in Research Registry (researchregistry5825).",2020,Primary outcomes were postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score.,"['unicompartmental knee replacement', 'patients and surgeons after unicompartmental knee replacement (UKR', 'patients who were scheduled for UKR with an American Society of Anesthesiologists status of I to III, who were mentally competent, and who were able to give consent for enrolment in the study', 'adults undergoing UKR']","['acetaminophen', 'oral acetaminophen', 'postoperative oral versus intravenous acetaminophen', 'acetaminophen or oral acetaminophen']","['postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score', 'pain control outcomes', 'morphine consumption at 24, 48, and 72\u200ahours after surgery, length of hospital stay, range of motion, daily ambulation distance, and adverse events occurrence']","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.0892136,Primary outcomes were postoperative pain at rest and during motion (knee flexion of 45°) measured using a visual analog scale score.,"[{'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Hengjun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021816']
1822,32846841,The efficacy of bidirectional barbed sutures for incision closure in total knee replacement: A protocol of randomized controlled trial.,"BACKGROUND


Barbed suture is a novel type of suture introduced in different surgical specialties. Nevertheless, its effect in total knee replacement is still unclear in terms of wound complications and cost effectiveness. The purpose of the present work is to evaluate the safety and efficacy of bidirectional barbed suture in reducing postoperative wound complications in the patients undergoing total knee replacement.
METHODS


This prospective, randomized, and controlled study was performed from January 2017 to December 2018. It was authorized via institutional review committee of Yuebei People's Hospital (GDYB1002189). Hundred participants were divided randomly into 2 groups, namely, control group (n = 50) and the study group (n = 50), respectively. All operations were performed using the Miller-Galante prosthesis (Zimmer; Warsaw, IN). For study groups, the joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture. At the end, extra 4 to 5 stitches were made to avoid detachment and incision rupture. For control group: the joint capsule was sutured by a traditional absorbable suture (Ethicon VICRYL* Plus 1-0), and the subcutaneous tissue was sutured by an absorbable suture (Ethicon VICRYL* Plus 2-0). The skin was sutured by staples. Incision length, suture time, operation time, postoperative length of hospital stay, and incision complications (such as effusion, infection, hematoma, and skin necrosis) were recorded. All data analyses are implemented through utilizing SPSS for Windows Version 20.0.
RESULTS


The results will be shown in Table 1.
CONCLUSION


This study can reach a reliable evidence for utilizing bidirectional barbed suture in wound closure in total knee replacement.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5823).",2020,"For study groups, the joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture.","['Hundred participants', 'total knee replacement', 'January 2017 to December 2018', 'patients undergoing total knee replacement']","['bidirectional barbed suture', 'joint capsule was sutured by a traditional absorbable suture (Ethicon VICRYL* Plus 1-0), and the subcutaneous tissue was sutured by an absorbable suture', 'joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture', 'bidirectional barbed sutures']","['safety and efficacy', 'Incision length, suture time, operation time, postoperative length of hospital stay, and incision complications (such as effusion, infection, hematoma, and skin necrosis']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0947694', 'cui_str': 'Vicryl'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0151799', 'cui_str': 'Skin necrosis'}]",0.0,0.0572576,"For study groups, the joint capsule (Stratafix1-0) and subcutaneous (Stratafix2-0) and intracutaneous (Stratafix3-0) tissues were sutured by a bidirectional barbed suture.","[{'ForeName': 'Zijian', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ""Department of Orthopedics, Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Wengang', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xi', 'Affiliation': ''}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021867']
1823,32847453,Effect of hybrid teaching incorporating problem-based learning on student performance in pathophysiology.,"OBJECTIVE


To compare the effectiveness of traditional and hybrid teaching strategies in pathophysiology and to conduct a survey of students' opinions about the hybrid teaching strategy.
METHODS


A hybrid pathophysiology course was developed by combining traditional lectures, case- or problem-based learning, group discussion and several quizzes. A total of 167 students were assigned to the hybrid teaching group and 118 students assigned to the traditional lecture group.
RESULTS


Compared with students who received traditional lectures, no students in the hybrid teaching class failed the final examination. The percentage of students with high scores was significantly higher in the hybrid teaching class. In addition, 73.7% of students in the hybrid teaching class expressed substantial interest in pathophysiology during the course, and 83% of these students felt they had received essential training and acquired the ability to solve clinical case problems.
CONCLUSION


The hybrid teaching strategy is an advanced approach that encourages students to actively learn teaching materials and solve practical clinical problems, and that promotes student interest in pathophysiology.",2020,The percentage of students with high scores was significantly higher in the hybrid teaching class.,['A total of 167 students were assigned to the hybrid teaching group and 118 students assigned to the'],"['traditional and hybrid teaching strategies', 'traditional lecture group', 'hybrid teaching incorporating problem-based learning']",['percentage of students with high scores'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",167.0,0.0183439,The percentage of students with high scores was significantly higher in the hybrid teaching class.,"[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Haolin', 'Initials': 'H', 'LastName': 'Bu', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Fu', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiaqing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pathophysiology, School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiangying', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'School of Basic Medical Sciences, Shanxi Medical University, Taiyuan, China.'}]",The Journal of international medical research,['10.1177/0300060520949402']
1824,32847980,Circulating Tumor Cells In Advanced Cervical Cancer:   NRG Oncology - Gynecologic Oncology Group Study 240 (NCT 00803062) .,"PURPOSE


To isolate circulating tumor cells (CTCs) from women with advanced cervical cancer and estimate the impact of CTCs and treatment on overall survival (OS) and progression-free survival (PFS).
EXPERIMENTAL DESIGN


7.5 mL of whole blood was drawn pre-cycle 1 and 36 days post-cycle 1 from patients enrolled on Gynecologic Oncology Group 0240, the phase III randomized trial that led directly to regulatory approval of the anti-angiogenesis drug, bevacizumab, in women with recurrent/metastatic cervical cancer. CTCs (defined as anti-cytokeratin positive/anti-CD45 negative cells) were isolated from the buffy coat layer using an anti-EpCAM antibody-conjugated ferrofluid and rare earth magnet, and counted using a semi-automated fluorescence microscope.
RESULTS


The median pre-cycle 1 CTC count was 7 CTCs/7.5 mL whole blood (range, 0-18) and, at 36 days post-treatment, was 4 (range, 0-17). The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95). Among patients with high (> median) pre-treatment CTCs, bevacizumab treatment was associated with a reduction in the hazard of death (HR 0.57; 95% CI, 0.32-1.03) and progression (PFS HR 0.59; 95% CI, 0.36-0.96). This effect was not observed with low (< median) CTCs.
CONCLUSIONS


CTCs can be isolated from women with advanced cervical cancer and may have prognostic significance. A survival benefit conferred by bevacizumab among patients with high pre-treatment CTCs may reflect increased tumor neovascularization and concomitant vulnerability to VEGF inhibition. These data support studying CTC capture as a potential predictive biomarker.",2020,"The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95).","['Advanced Cervical Cancer', 'women with advanced cervical cancer', 'women with recurrent/metastatic cervical cancer']","['regulatory approval of the anti-angiogenesis drug, bevacizumab', 'bevacizumab']","['median pre-cycle 1 CTC count', 'overall survival (OS) and progression-free survival (PFS', 'risk of death', 'declination in CTCs', 'hazard of death']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278584', 'cui_str': 'Cervix cancer metastatic'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.128951,"The greater the declination in CTCs between time points studied, the lower the risk of death (HR 0.87; 95% CI, 0.79-0.95).","[{'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'OB/GYN, University of California Medical Center, Irvine ktewari@uci.edu.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'CTDD, Roswell Park Comprehensive Cancer Center.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Division of Gynecologic Oncology, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, St. Joseph's Hospital.""}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Hem Onc, Massachusetts General Hospital.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Moore', 'Affiliation': 'Gyn Onc, Franciscan St. Francis Health.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'Operations Center- Philadelphia East, NRG Oncology.'}, {'ForeName': 'Lois M', 'Initials': 'LM', 'LastName': 'Ramondetta', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Landrum', 'Affiliation': 'Departments of Pathology and Obstetrics and Gynecology, University of Oklahoma Health Sciences Center.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Randall', 'Affiliation': 'Gynecologic Oncology, Virginia Commonwealth University.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Oaknin', 'Affiliation': ""Medical Oncology Gynaecological Cancer Unit, Vall d'Hebron University Hospital Vall d'Hebron Institute of Oncology (VHIO).""}, {'ForeName': 'Mario M', 'Initials': 'MM', 'LastName': 'Leitao', 'Affiliation': 'Surgery, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Eisenhauer', 'Affiliation': 'OB/GYN, Massachusetts General Hospital.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DiSilvestro', 'Affiliation': ""Program in Women's Oncology, Women and Infants Hospital,\xa0Providence, RI\xa002905.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Le', 'Affiliation': 'School of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Obstetrics, Gynecology and Reproductive Medicine, Stony Brook University Medical Center.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Burke', 'Affiliation': 'Gynecologic Oncology, Southeast Cancer Control Consortium.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Salani', 'Affiliation': 'Ohio State University College of Medicine.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Richardson', 'Affiliation': 'Obstetrics and Gynecology, UT Southwestern Medical Center at Dallas.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Michael', 'Affiliation': 'Pathology, Indiana University School of Medicine.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kindelberger', 'Affiliation': 'Boston Medical Center BMC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'Medicine, University of Alabama at Birmingham.'}]",Molecular cancer therapeutics,['10.1158/1535-7163.MCT-20-0276']
1825,32853783,Coffee consumption for recovery of intestinal function after laparoscopic gynecological surgery: A randomized controlled trial.,"BACKROUND


To investigate the effect of postoperative coffee consumption on bowel motility after laparoscopic gynecological surgery.
MATERIALS AND METHODS


In this randomized controlled trial, patients were allocated postoperatively to 3 cups of either coffee or warm water at 6, 12, or 18 h after the operation. Total hysterectomy and bilateral salpingectomy were performed on all patients. In addition, a salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy were performed according to clinical indications. The primary endpoint was time to the first passage of flatus after surgery.
RESULTS


A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water). The median time to flatus (19 [13-35] vs. 25 [15-42] h; hazard ratio [HR] 1.9, 95% confidence interval [CI], 1.2-2.9; P = 0.0009), median time to defecation (30 [22-54] vs. 38 [26-65] h, HR 2.4, 95% CI, 1.5-3.8; P < 0.0001), and mean time to tolerate food (2 [2-5] vs. 3 [2-8] days, HR 1.5, 95% CI, 1.02-2.3; P = 0.002) were decreased significantly in patients who consumed coffee compared with the control subjects. Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02). No adverse events were attributed to coffee consumption.
CONCLUSION


Postoperative coffee intake after laparoscopic gynecological surgery hastened the recovery of gastrointestinal function by reducing the time to the first passage of flatus, time to the first defecation, and time to tolerate a solid diet. This simple, cheap, and well-tolerated treatment merits routine use alongside other existing enhanced recovery pathways in the postoperative setting.",2020,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"['A total of 96 patients were enrolled; 49 patients were assigned to the coffee group, and 47 were enrolled in the control group (warm water', 'after laparoscopic gynecological surgery']","['salpingo-oophorectomy and systematic pelvic with/without para-aortic lymphadenectomy', 'Coffee consumption', 'postoperative coffee consumption']","['mean time to tolerate food', 'intestinal function', 'Total hysterectomy and bilateral salpingectomy', 'adverse events', 'bowel motility', 'time to the first passage of flatus after surgery', 'Postoperative ileus', 'recovery of gastrointestinal function', 'median time to flatus', 'median time to defecation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0036132', 'cui_str': 'Salpingo-oophorectomy'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0677962', 'cui_str': 'Total hysterectomy'}, {'cui': 'C0195509', 'cui_str': 'Bilateral complete salpingectomy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",96.0,0.115899,Postoperative ileus was observed in seven patients (14.9%) in the control group and one patient (2.0%) in the coffee group (P = 0.02).,"[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Gungorduk', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey. Electronic address: drkemalgungorduk@gmail.com.'}, {'ForeName': 'Ezgi Karakas', 'Initials': 'EK', 'LastName': 'Paskal', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Demirayak', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sezen Bozkurt', 'Initials': 'SB', 'LastName': 'Köseoğlu', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Akbaba', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Isa Aykut', 'Initials': 'IA', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.016']
1826,32853919,Validation of sleep stage classification using non-contact radar technology and machine learning (Somnofy®).,"OBJECTIVE


To validate automatic sleep stage classification using deep neural networks on sleep assessed by radar technology in the commercially available sleep assistant Somnofy® against polysomnography (PSG).
METHODS


Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions. The Somnofy unit was placed in two different locations per room (nightstand and wall). The sleep algorithm was validated against PSG using a 25-fold cross validation technique, and performance was compared to the inter-rater reliability between the PSG sleep scored by two independent sleep specialists.
RESULTS


Epoch-by-epoch analyses showed a sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake) for Somnofy of 0.97 and 0.72 respectively, compared to 0.99 and 0.85 for the PSG scorers. The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96. The intraclass correlation coefficient revealed excellent and good reliability for total sleep time and sleep efficiency, while sleep onset and R latency had poor agreement. Somnofy underestimated total wake time by 5 min and N1/N2 by 3 min. N3 was overestimated by 4 min and R by 3 min. Results were independent of institution and sensor location.
CONCLUSION


Somnofy showed a high accuracy staging sleep in healthy individuals and has potential to assess sleep quality and quantity in a sample of healthy, mostly young adults. More research is needed to examine performance in children, older individuals and those with sleep disorders.",2020,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","['children, older individuals and those with sleep disorders', 'Seventy-one nights of overnight sleep in healthy individuals were assessed by both PSG and Somnofy at two different institutions', 'healthy individuals']",['non-contact radar technology and machine learning (Somnofy®'],"['sleep stage differentiation', 'total wake time', 'accuracy staging sleep', 'total sleep time and sleep efficiency', 'sensitivity (accuracy to detect sleep) and specificity (accuracy to detect wake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}]","[{'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0201471,"The sleep stage differentiation for Somnofy was 0.75 for N1/N2, 0.74 for N3 and 0.78 for R, whilst PSG scorers ranged between 0.83 and 0.96.","[{'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Toften', 'Affiliation': 'Department of Data Science, VitalThings AS, Tønsberg, Norway. Electronic address: st@vitalthings.com.'}, {'ForeName': 'Ståle', 'Initials': 'S', 'LastName': 'Pallesen', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway; Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hrozanova', 'Affiliation': 'Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Frode', 'Initials': 'F', 'LastName': 'Moen', 'Affiliation': 'Department of Education and Lifelong Learning, Centre of Elite Sport Research, NTNU, Trondheim, Norway.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Grønli', 'Affiliation': 'Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.'}]",Sleep medicine,['10.1016/j.sleep.2020.02.022']
1827,32854000,Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial.,"BACKGROUND


HIV-infected people who use drugs (PWUD) have poor HIV outcomes. Few studies tested interventions to improve HIV outcomes among PWUD. Abstinence-reinforcing contingency management (CM) reduces drug use and could also improve HIV outcomes.
METHODS


From 2012-2017, we conducted a randomized controlled trial testing whether a 16-week abstinence-reinforcing CM intervention improved HIV viral load (VL) among HIV-infected adults using opioids or cocaine. In the CM intervention, drug-free urines led to escalating value of vouchers ($2.50-$80/voucher, $1320 total maximum). In intention-to-treat mixed-effects linear and logistic regression analyses, we examined whether the CM intervention improved log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes).
RESULTS


Thirty-seven participants were randomized to the CM intervention and 36 to control. Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6%). In CM (vs. control) participants, mean reduction in log 10  VL was greater (-0.16 log 10  VL copies/mL per 4-week period; 95% CI: -0.29 to -0.03, p < 0.05). Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants. The CM intervention was not significantly associated with abstinence or adherence.
CONCLUSIONS


This is the first study to demonstrate improvements in HIV VL via an abstinence-reinforcing CM intervention. Because the CM intervention did not significantly affect abstinence or adherence, the mechanism of its effect is unclear. To end the HIV epidemic, innovative strategies must address individuals with poor HIV outcomes. Abstinence-reinforcing CM may be one potential strategy to improve HIV outcomes among a select group of PWUD.",2020,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","['From 2012-2017', 'HIV-infected people who use drugs', 'Thirty-seven participants', 'HIV-infected adults using', 'Median age was 49.2 years; most were male (61.6%) and non-Hispanic black (46.6']","['opioids or cocaine', 'Abstinence-reinforcing contingency management (CM', 'CM intervention', 'abstinence-reinforcing CM intervention', 'Abstinence-reinforcing contingency management']","['mean reduction in log 10  VL', 'log 10  VL (primary outcome), abstinence and antiretroviral adherence (secondary outcomes', 'HIV viral load suppression', 'HIV outcomes', 'HIV viral load (VL', 'abstinence or adherence']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",37.0,0.178726,"Over 16 weeks, CM participants had a mean reduction of 0.64 copies/mL in log 10  VL greater than control participants.","[{'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States. Electronic address: ccunning@montefiore.org.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Chenshu', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Clemson University College of Behavioral, Social and Health Sciences, Department of Public Health Sciences, Clemson Nursing Building, 605 Grove Road, Greenville, SC 29605, United States.'}, {'ForeName': 'Marcus A', 'Initials': 'MA', 'LastName': 'Bachhuber', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States; Lousiana State University Health Sciences Center-New Orleans, Section of Community and Population Medicine, Department of Medicine, 533 Bolivar St, New Orleans, LA 70112, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Jost', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grossberg', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Stein', 'Affiliation': 'Albert Einstein College of Medicine & Montefiore Medical Center, 111 E. 210th Street, Bronx, NY 10467, United States.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Sohler', 'Affiliation': 'City University of New York, School of Medicine, 160 Convent Ave, New York, NY 10031, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108230']
1828,32854052,Does symptom severity matter in stepped and collaborative care for depression?,"BACKGROUND


We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments.
METHODS


Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively.
RESULTS


For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p < 0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD.
LIMITATIONS


There was a high proportion of missing values among severely depressed patients, especially in SCM.
CONCLUSION


SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.",2020,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","['primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments', '737 participating patients (SCM: n\xa0=\xa0569; TAU: n\xa0=\xa0168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70']","['SCM', 'SCM and TAU', 'stepped and collaborative care model (SCM) vs. treatment as usual (TAU']",['severity ((mild-moderate (MMD); severe depression (SD'],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}]",737.0,0.0676647,"Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD.","[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Watzke', 'Affiliation': 'Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Binzmühlestrasse 14/16, CH-8050 Zurich, Switzerland. Electronic address: birgit.watzke@uzh.ch.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: d.heddaeus@uke.de.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Steinmann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.steinmann@uke.de.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: a.daubmann@uke.de.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: k.wegscheider@uke.uni-hamburg.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Electronic address: m.haerter@uke.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.079']
1829,32861841,Longitudinal trajectories of mood symptoms and global functioning in youth at high risk for bipolar disorder.,"BACKGROUND


Little is known about the longitudinal course of mood symptoms and functioning in youth who are at high risk for bipolar disorder (BD). Identifying distinct course trajectories and predictors of those trajectories may help refine treatment approaches.
METHODS


This study examined the longitudinal course of mood symptoms and functioning ratings in 126 youth at high risk for BD based on family history and early mood symptoms. Participants were enrolled in a randomized trial of family-focused therapy and followed longitudinally (mean 2.0 years, SD = 53.6 weeks).
RESULTS


Using latent class growth analyses (LCGA), we observed three mood trajectories. All youth started the study with active mood symptoms. Following the index mood episode, participants were classified as having a ""significantly improving course"" (n = 41, 32.5% of sample), a ""moderately symptomatic course"" (n = 21, 16.7%), or a ""predominantly symptomatic course"" (n = 64, 50.8%) at follow-up. More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness. LCGA also revealed three trajectories of global functioning that closely corresponded to symptom trajectories; however, fewer youth exhibited functional recovery than exhibited symptomatic recovery.
LIMITATIONS


Mood trajectories were assessed within the context of a treatment trial. Ratings of mood and functioning were based on retrospective recall.
CONCLUSIONS


This study suggests considerable heterogeneity in the course trajectories of youth at high risk for BD, with a significant proportion (32.5%) showing long-term remission of symptoms. Treatments that enhance psychosocial functioning may be just as important as those that ameliorate symptoms in youth at risk for BD.",2020,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","['126 youth at high risk for BD based on family history and early mood symptoms', 'youth at high risk for bipolar disorder', 'youth who are at high risk for bipolar disorder (BD']",['LCGA'],"['severe depression, anxiety, and suicidality']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0524716,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.018']
1830,32841725,"A commentary on ""effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" (Int. J. Surg. 2020; 80:13-18).",,2020,,['elderly patients undergoing hip joint replacement surgery'],['edaravone'],['postoperative cognitive function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Zhao-Jing', 'Initials': 'ZJ', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China. Electronic address: xuefushan@aliyun.com.'}, {'ForeName': 'Yu-Jing', 'Initials': 'YJ', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, PR China.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.08.020']
1831,32841846,Decreased functional connectivity within the salience network after two-week morning bright light exposure in individuals with sleep disturbances: a preliminary randomized controlled trial.,"BACKGROUND


Bright light (BL) exposure is a safe non-pharmacological intervention for sleep disturbances. However, the functional brain correlates underlying the effects of bright light exposure need to be further clarified. As alterations in the salience network were reported in individuals with sleep disturbances, we have investigated whether bright light exposure may improve sleep quality by altering functional connectivity in this network.
METHODS


In the current study, 30 individuals with sleep disturbances were randomly assigned to one of the two interventions for two weeks: (1) 1 h of bright light (10,000 lux) exposure (BL-exposed group) and (2) 1 h of dim light (<300 lux) exposure (DL-exposed group). Sleep characteristics and functional connectivity in the salience network were assessed by sleep diary and resting-state functional magnetic resonance imaging, respectively, as outcome measures at before and after the intervention.
RESULTS


After two weeks of the intervention, the BL-exposed group showed greater improvement with respect to sleep efficiency (t = 2.27, p = 0.03) and sleep latency (t = -2.40, p = 0.03) as compared to the DL-exposed group. In addition, functional connectivity decreased in the cluster that encompasses the right anterior insular and the frontal opercular regions in the salience network (uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group. Decreased functional connectivity in the cluster was associated with decreased sleep latency in the BL-exposed group (β = 0.54, p = 0.01).
CONCLUSIONS


Our results suggest that bright light exposure may improve sleep quality in individuals with sleep disturbances by modulating functional connectivity in the salience network.
CLINICAL TRIAL REGISTRATION


https://cris.nih.go.kr/cris; KCT0002607.",2020,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","['individuals with sleep disturbances', '30 individuals with sleep disturbances']","['bright light (10,000 lux) exposure (BL-exposed group) and', 'Bright light (BL) exposure', 'bright light exposure']","['sleep efficiency', 'functional connectivity', 'Decreased functional connectivity', 'sleep latency', 'sleep quality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]","[{'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.0552621,"(uncorrected p < 0.001, cluster size>100 mm 3 ) in the BL-exposed group.","[{'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Myeongju', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Jungyoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Gahae', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Eun', 'Initials': 'E', 'LastName': 'Namgung', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'Soo Mee', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Department of Radiology, Ewha W. University, Seoul, South Korea.'}, {'ForeName': 'In Kyoon', 'Initials': 'IK', 'LastName': 'Lyoo', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea; Graduate School of Pharmaceutical Sciences, Ewha W. University, Seoul, South Korea; Department of Psychiatry, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Ewha Brain Institute, Ewha W. University, Seoul, South Korea; Department of Brain and Cognitive Sciences, Ewha W. University, Seoul, South Korea. Electronic address: sujungjyoon@ewha.ac.kr.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.009']
1832,32843372,Efficacy and Safety of Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized Controlled Trial.,"BACKGROUND AND OBJECTIVES


Expanded hemodialysis therapy enabled by medium cut-off membranes may promote greater clearance of larger middle molecules that comprise putative uremic solutes than conventional high-flux dialysis. This randomized trial evaluated the efficacy and safety of hemodialysis treatment with a medium cut-off dialyzer.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Clinically stable patients on maintenance hemodialysis were randomized to receive dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H) over 24 weeks of treatment. The primary safety end point was the predialysis serum albumin level after 24 weeks of treatment. The primary efficacy end point was the reduction ratio of free  λ  light chains at 24 weeks of treatment.
RESULTS


Among 172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years. Of the 86 patients randomized to each dialyzer, 65 completed the trial in each group. The reduction ratio for the removal of free  λ  light chains was significantly higher in the Theranova 400 group compared with the Elisio-17H group after 4 weeks (39% versus 20%) and 24 weeks (33% versus 17%; both  P <0.001). Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
CONCLUSIONS


Hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of larger middle molecules, as exemplified by free  λ  light chains, compared with a similar size high-flux dialyzer, while maintaining serum albumin level.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


A Multi-Center, Prospective, Randomized, Controlled, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer in End Stage Renal Disease (ESRD) Patients, NCT03257410.",2020,"Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
","['86 patients randomized to each dialyzer, 65 completed the trial in each group', '172 patients on maintenance hemodialysis, mean age was 59±13 years, 61% were men, 40% were Black, and mean dialysis vintage was 5±4 years', 'Clinically stable patients on maintenance hemodialysis']","['Elisio-17H', 'dialysis with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (Elisio-17H', 'Expanded Hemodialysis with the Theranova 400 Dialyzer', 'hemodialysis treatment with a medium cut-off dialyzer']","['reduction ratio for the removal of free  λ  light chains', 'complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin', 'efficacy and safety', 'Safety and Efficacy', 'predialysis serum albumin level', 'Efficacy and Safety', 'reduction ratio of free  λ  light chains', 'IL-6. Predialysis serum albumin levels', 'predialysis serum albumin levels', 'larger reduction ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0033457', 'cui_str': 'Complement factor D'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0549177', 'cui_str': 'Large'}]",86.0,0.0677605,"Among secondary end points, the Theranova 400 group demonstrated significantly larger reduction ratios at 4 and 24 weeks for complement factor D, free  κ  light chains, TNF α , and  β 2-microglobulin ( P <0.001 for all), but not for IL-6. Predialysis serum albumin levels were similar between groups after 24 weeks (4 g/dl with the Theranova 400 and 4.1 g/dl with the Elisio-17H), consistent with noninferiority of the Theranova 400 dialyzer in maintaining predialysis serum albumin levels after 24 weeks of treatment.
","[{'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Tufts Medical Center, Medicine, Nephrology, Boston, Massachusetts.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Falzon', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, San Gwann, Malta luke_falzon@baxter.com.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Skoufos', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Angelito', 'Initials': 'A', 'LastName': 'Bernardo', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Beck', 'Affiliation': 'Baxter International Inc., Worldwide Medical, Hechingen, Germany.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}, {'ForeName': 'Ha', 'Initials': 'H', 'LastName': 'Tran', 'Affiliation': 'Baxter Healthcare Corporation, Worldwide Medical, Deerfield, Illinois.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01210120']
1833,32843374,Changes in Blood Pressure and Arterial Hemodynamics following Living Kidney Donation.,"BACKGROUND AND OBJECTIVES


The Effect of a Reduction in GFR after Nephrectomy on Arterial Stiffness and Central Hemodynamics (EARNEST) study was a multicenter, prospective, controlled study designed to investigate the associations of an isolated reduction in kidney function on BP and arterial hemodynamics.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS


Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research. Participants underwent office and ambulatory BP measurement, assessment of arterial stiffness, and biochemical tests at baseline and 12 months.
RESULTS


A total of 469 participants were recruited, and 306 (168 donors and 138 controls) were followed up at 12 months. In the donor group, mean eGFR was 27 ml/min per 1.73 m 2  lower than baseline at 12 months. Compared with baseline, at 12 months the mean within-group difference in ambulatory day systolic BP in donors was 0.1 mm Hg (95% confidence interval, -1.7 to 1.9) and 0.6 mm Hg (95% confidence interval, -0.7 to 2.0) in controls. The between-group difference was -0.5 mm Hg (95% confidence interval, -2.8 to 1.7;  P =0.62). The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls. The between-group difference was 0.1 m/s (95% confidence interval, -0.2 to 0.3;  P =0.49).
CONCLUSIONS


Changes in ambulatory peripheral BP and pulse wave velocity in kidney donors at 12 months after nephrectomy were small and not different from controls.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


NCT01769924 (https://clinicaltrials.gov/ct2/show/NCT01769924).",2020,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","['Prospective living kidney donors and healthy controls who fulfilled criteria for donation were recruited from centers with expertise in vascular research', 'A total of 469 participants were recruited, and 306 (168 donors and 138 controls', 'Living Kidney Donation']",[],"['ambulatory peripheral BP and pulse wave velocity', 'Blood Pressure and Arterial Hemodynamics', 'ambulatory day systolic BP', 'mean eGFR', 'pulse wave velocity']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0260788', 'cui_str': 'Donor of kidney for transplant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}]",[],"[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",469.0,0.332628,"The mean within-group difference in pulse wave velocity in donors was 0.3 m/s (95% confidence interval, 0.1 to 0.4) and 0.2 m/s (95% confidence interval, -0.0 to 0.4) in controls.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Price', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom annaprice@doctors.org.uk.'}, {'ForeName': 'George H B', 'Initials': 'GHB', 'LastName': 'Greenhall', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Moody', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Steeds', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Edwards', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Manvir K', 'Initials': 'MK', 'LastName': 'Hayer', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Pickup', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Radhakrishnan', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Law', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': ""Renal and Transplantation Unit, St George's University Hospitals National Health Service Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Campbell', 'Affiliation': 'Manchester Royal Infirmary, Manchester, United Kingdom.'}, {'ForeName': 'Charles R V', 'Initials': 'CRV', 'LastName': 'Tomson', 'Affiliation': 'Southmead Hospital, Bristol, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cockcroft', 'Affiliation': 'Department of Cardiology, Wales Heart Research Institute, University Hospital, Cardiff, United Kingdom.'}, {'ForeName': 'Badri', 'Initials': 'B', 'LastName': 'Shrestha', 'Affiliation': 'Sheffield Kidney Institute, Sheffield Teaching Hospitals National Health Service Foundation Trust, Sheffield, United Kingdom.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': ""Cambridge Clinical Trials Unit, Clinical School, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.""}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Tomlinson', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ferro', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Townend', 'Affiliation': 'Birmingham Cardio-Renal Group, Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.15651219']
1834,32847776,Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial.,"OBJECTIVE


Duloxetine has been recently used as a part of multimodal analgesia in perioperative settings, yet the optimal dose of Duloxetine is not determined.
DESIGN


A parallel, randomized, placebo-controlled trial.
SETTING


Tertiary level oncology center.
PATIENTS


88 female patients with breast cancer were subjected to modified radical mastectomy (MRM) with ASA class I and II were recruited.
INTERVENTION


Participants were randomly allocated into 4 equal groups received 2 h preoperatively, placebo (D0, N = 22), Duloxetine 30 mg (D30, N = 22), Duloxetine 60 mg (D60, N = 22) and Duloxetine 90 mg (D90, N = 22) tablet.
MEASUREMENTS


The primary outcome; 24 h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting) were measured.
RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
CONCLUSION


Preoperative oral Duloxetine of 60 mg, for patients subjected to MRM is the optimal dose considering its analgesic efficacy and side effects.
TRIAL REGISTRATION


The trial was registered at Clinical Trials.gov with unique ID number; NCT03468348.",2020,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","['88 female patients with breast cancer', 'patients undergoing modified radical mastectomy', 'Tertiary level oncology center']","['Duloxetine', 'modified radical mastectomy (MRM) with ASA class', '2\xa0h preoperatively, placebo', 'Duloxetine 30\xa0mg (D30, N\xa0=\xa022), Duloxetine 60\xa0mg (D60, N\xa0=\xa022) and Duloxetine 90\xa0mg (D90, N\xa0=\xa022) tablet', 'placebo', 'morphine', 'Preoperative Duloxetine']","['level of sedation', 'analgesic efficacy and side effects', '24\xa0h cumulative postoperative morphine consumption and the secondary outcomes; VAS score of pain intensity, quality of recovery (QoR-40), time to Aldrete 9, and side effects (sedation and vomiting', 'vomiting', 'median (IQR) consumption', 'acute pain and quality of recovery']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1616501', 'cui_str': 'duloxetine 30 MG [Cymbalta]'}, {'cui': 'C1667738', 'cui_str': 'duloxetine 60 MG'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]",88.0,0.273346,"RESULTS


The median (IQR) consumption of morphine (mg) in the first postoperative 24 h was significantly decreased in both (D60 and D90) groups compared to (D0 and D30) groups, P < 0.001(Bonferroni corrected), however, a non-significant reduction was observed between D90 group vs. D60 group and D30 group vs. D0 group, P = 0.595 and P = 0.462 respectively, D60 vs. D0; 0(0-6) vs. 10(9-12), D60 vs. D30; 0(0-6) vs. 9(8-11), D90 vs. D0; 0(0-5) vs. 10(9-12), D90 vs. D30; 0(0-5) vs. 9(8-11), D90 vs. D60; 0(0-5) vs. 0(0-6), D30 vs. D0; 9(8-11) vs. 10(9-12), patients in D90 group took longer time to recover from anesthesia "" time to Aldrete 9"" and showed an increased level of sedation in comparison with other groups, vomiting was more frequent in the D90 group.
","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Nourhan Alaa', 'Initials': 'NA', 'LastName': 'Elgalaly', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}, {'ForeName': 'Helal F', 'Initials': 'HF', 'LastName': 'Hetta', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Medical Microbiology and Immunology, Faculty of Medicine, Assiut University, Assiut, Egypt. Electronic address: Helal.hetta@uc.edu.'}, {'ForeName': 'Montaser A', 'Initials': 'MA', 'LastName': 'Fattah Mohammad', 'Affiliation': 'Department of Anesthesia and Pain Management, South Egypt Cancer Institute, Assiut University, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110007']
1835,32846062,A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.,"BACKGROUND


A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.
METHODS


In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.
RESULTS


A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
CONCLUSIONS


In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).",2020,"No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
","['children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump', 'children with type 1 diabetes', 'children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a', 'Children with Type 1 Diabetes', '101 children']","['Closed-Loop Control', 'closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group']","['median percentage of time that the system', 'diabetic ketoacidosis or severe hypoglycemia', 'median percentage of time that the glucose level', 'glycated hemoglobin levels', 'glycemic outcomes', 'mean (±SD) percentage of time that the glucose level', 'percentage of time that the glucose level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",101.0,0.0869124,"No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
","[{'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Ekhlaspour', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Forlenza', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Schoelwer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Ruedy', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jost', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Carria', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Emory', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Liana J', 'Initials': 'LJ', 'LastName': 'Hsu', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Oliveri', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Kollman', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Betsy B', 'Initials': 'BB', 'LastName': 'Dokken', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Buckingham', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cherñavvsky', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'From the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.B., M.S., E.E., M.O., M.D.D., D.C.); the Jaeb Center for Health Research, Tampa, FL (L.G.K., R.W.B., K.J.R., C.C.K.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (L.E., L.J.H., B.A.B.), and Tandem Diabetes Care, San Diego (B.B.D.) - both in California; the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (G.P.F., E.J., R.P.W.); and the Department of Pediatrics, Yale University School of Medicine, New Haven, CT (E.C., L.C., S.A.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004736']
1836,32854478,[Regulatory relationship between lncRNA KCNQ1OT1 and miR-146a-3p in preeclampsia].,"Objective:  To observe the changes of the expression level of long non-coding RNA (lncRNA) KCNQ1OT1 and microRNA (miR)-146a-3p in placenta tissues of preeclampsia (PE) patients, as well as their effect and mechanism on the biological functions of trophoblast cells.  Methods:  A total of 45 cases of hospitalized PE patients in Hainan General Hospital from July 2017 to July 2018 were selected as the PE group, 55 normal pregnant women during the same period were chosed as the control group. The expression level of KCNQ1OT1 mRNA and miR-146a-3p in the placenta tissues between two groups were detected by using quantitative real time (qRT)-PCR. Pearson's test was furtherly analyzed the correlation between them. Human trophoblast cell line (HTR8/SVneo) were randomly divided into control and lipopolysaccharide (LPS) groups, and then LPS group were divide into four sub-groups,included LPS group, short hairpin RNA (sh)-KCNQ1OT1 (after silencing the expression of KCNQ1OT1), miR-146a-3p inhibitor and sh-KCNQ1OT1+miR-146a-3p inhibitor. The targeting relationship between KCNQ1OT1 and miR-146a-3p were predicted by bioinformatics software and confirmed by luciferase assay. The cell proliferation and invasion capacities were respectively detected by cell counting kit-8 (CCK-8) and transwell assay. The expression level of KCNQ1OT1 mRNA and miR-146a-3p were detected by qRT-PCR and the protein expression level of CXC chemokine ligand 12 （CXCL12） and CXC chemokine receptor type 4 (CXCR4) were tested by western blot.  Results:  (1) The mRNA expression level of KCNQ1OT1 in the placenta of PE group was lower than that of control group (0.23±0.03 vs 0.51±0.04,  P <0.05), and the miR-146a-3p expression level was higher than that of the control group (0.49±0.03 vs 0.31±0.03,  P <0.05), there were statistical significant differences between the two groups. (2) Luciferase assay showed that there was a targeting relationship between KCNQ1OT1 and mir-146a-3p. Compared with the control group, the mRNA expression level of KCNQ1OT1 in the LPS group were significantly decreased (0.91±0.03 vs 0.35±0.03,  P <0.05), and the expression level of miR-146a-3p were significantly increased (0.22±0.03 vs 0.63±0.04,  P <0.05). The cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 significantly reduced in the LPS group compared with control group (all  P <0.05). The mRNA expression level of KCNQ1OT1 (0.23±0.03) in the sh-KCNQ1OT1 group were further decreased, the expression of miR-146a-3p (0.85±0.03) were further increased, and the cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 were all further reduced compared with control group，there were significant difference between two groups (all  P <0.05). Comparing the miR-146a-3p inhibitor group, and sh-KCNQ1OT1+miR-146a-3p inhibitor group with the sh-KCNQ1OT1 group, respectively, the expression level of KCNQ1OT1 mRNA (0.78±0.04 vs 0.50±0.03) increased, and the expression level of miR-146a-3p (0.42±0.03 vs 0.46±0.03) decreased, the cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 were all increased ,there were statistically significant differences (all  P <0.05).  Conclusion:  KCNQ1OT1 could target the regulation of miR-146a-3p through CXCL12/CXCR4 pathway in the proliferation, invasion an migration of HTR8/SVneo cells, which may be involved in the pathogenesis of PE.",2020,"The cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 significantly reduced in the LPS group compared with control group (all  P <0.05).","['45 cases of hospitalized PE patients in Hainan General Hospital from July 2017 to July 2018 were selected as the PE group, 55 normal pregnant women during the same period were chosed as the control group', 'preeclampsia']","['LPS group, short hairpin RNA (sh)-KCNQ1OT1 (after silencing the expression of KCNQ1OT1), miR-146a-3p inhibitor and sh-KCNQ1OT1+miR-146a-3p inhibitor', 'lipopolysaccharide (LPS', 'miR-146a-3p inhibitor group, and sh-KCNQ1OT1+miR-146a-3p inhibitor', 'Human trophoblast cell line (HTR8/SVneo']","['expression level of long non-coding RNA (lncRNA) KCNQ1OT1 and microRNA', 'cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4', 'expression of miR-146a-3p', 'cell proliferation and invasion capacities', 'miR-146a-3p expression level', 'expression level of KCNQ1OT1 mRNA', 'expression level of KCNQ1OT1 mRNA and miR-146a-3p in the placenta tissues', 'mRNA expression level of KCNQ1OT1', 'expression level of miR-146a-3p', 'expression level of KCNQ1OT1 mRNA and miR-146a-3p']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445505', 'cui_str': 'Hainan'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2930586', 'cui_str': 'shRNA'}, {'cui': 'C1436653', 'cui_str': 'KCNQ1OT1 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041178', 'cui_str': 'Trophoblast structure'}, {'cui': 'C0007600', 'cui_str': 'Cell Line'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1436653', 'cui_str': 'KCNQ1OT1 protein, human'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0218504', 'cui_str': 'CXCL12 Chemokine'}, {'cui': 'C2352110', 'cui_str': 'CXCR4 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",55.0,0.0163295,"The cell proliferation, invasion and migration capacities and the protein expression of CXCL12 and CXCR4 significantly reduced in the LPS group compared with control group (all  P <0.05).","[{'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cen', 'Affiliation': ''}, {'ForeName': 'W C', 'Initials': 'WC', 'LastName': 'Chen', 'Affiliation': ''}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200322-00246']
1837,32855225,Efficacy and safety of TOBI Podhaler® in  Pseudomonas aeruginosa -infected bronchiectasis patients: iBEST study.,"INTRODUCTION


The study aimed to determine the efficacy of a safe and well-tolerated dose and regimen of tobramycin inhalation powder (TIP) on  Pseudomonas aeruginosa  ( Pa ) sputum density in patients with bronchiectasis (BE).
METHODS


This is a phase II, double-blind, randomised study in BE patients aged ≥18 years with chronic  Pa  infection. Patients were randomised 1:1:1 to either Cohort A: 3 capsules of TIP O.D. (84 mg); Cohort B: 5 capsules O.D. (140 mg) or Cohort C: 4 capsules B.I.D. (224 mg). Within each cohort, patients were further randomised 2:2:1 either to TIP continuously, TIP cyclically (alternating 28 days of TIP and placebo) or placebo for 16 weeks, respectively, and were followed up for 8 weeks.
RESULTS


Overall, 107 patients were randomised to Cohorts A (n=34), B (n=36) and C (n=37). All three TIP doses significantly reduced the  Pa  sputum density from baseline to Day 29  versus  placebo in a dose-dependent manner (p≤0.0001, each). A smaller proportion of patients in the continuous-TIP (34.1%) and cyclical-TIP (35.7%) groups experienced pulmonary exacerbations  versus  placebo (47.6%) and also required fewer anti-pseudomonal antibiotics (38.6% on continuous-TIP and 42.9% on cyclical-TIP)  versus  placebo (57.1%) although not statistically significant. Pulmonary exacerbation of BE was the most frequent (37.4%) adverse event (AE). Overall, TIP was well tolerated, however, 23.4% of the patients discontinued the study drug due to AEs.
CONCLUSION


Continuous- and cyclical-TIP regimens with all three doses were safe and effective in reducing the  Pa  sputum density in patients with BE and chronic  Pa  infection.",2020,"All three TIP doses significantly reduced the  Pa  sputum density from baseline to Day 29  versus  placebo in a dose-dependent manner (p≤0.0001, each).","['107 patients were randomised to Cohorts A (n=34), B (n=36) and C (n=37', 'patients with bronchiectasis (BE', 'Pseudomonas aeruginosa -infected bronchiectasis patients', 'BE patients aged ≥18\u2005years with chronic  Pa  infection', 'patients with BE and chronic  Pa  infection']","['TIP continuously, TIP cyclically (alternating 28\u2005days of TIP and placebo) or placebo', 'TIP O.D', 'placebo', 'tobramycin inhalation powder (TIP', 'TOBI Podhaler®']","['pulmonary exacerbations', 'Pulmonary exacerbation of BE', 'anti-pseudomonal antibiotics', 'Pa  sputum density', 'cyclical-TIP']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C3556836', 'cui_str': 'Tobramycin Inhalation Powder'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0723764', 'cui_str': 'Tobi'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C3556836', 'cui_str': 'Tobramycin Inhalation Powder'}]",107.0,0.217363,"All three TIP doses significantly reduced the  Pa  sputum density from baseline to Day 29  versus  placebo in a dose-dependent manner (p≤0.0001, each).","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Loebinger', 'Affiliation': 'Host Defence Unit, Royal Brompton Hospital and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Polverino', 'Affiliation': ""Respiratory Disease Department, Vall d' Hebron University Hospital - VHIR, Barcelona, Spain.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, Scotland, UK.'}, {'ForeName': 'Harm A W M', 'Initials': 'HAWM', 'LastName': 'Tiddens', 'Affiliation': ""Department of Paediatric Pulmonology and Allergology, Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Clinical Microbiology, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tunney', 'Affiliation': ""Halo Research Group, School of Pharmacy, Queen's University Belfast, Belfast, UK M.Loebinger@rbht.nhs.uk.""}, {'ForeName': 'Felix C', 'Initials': 'FC', 'LastName': 'Ringshausen', 'Affiliation': 'Department of Respiratory Medicine, Hannover Medical School, and Biomedical Research in End-stage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (DZL), Hannover, Germany.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Hill', 'Affiliation': 'Department of Respiratory Medicine, Royal Infirmary of Edinburgh, and University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rashidkhan', 'Initials': 'R', 'LastName': 'Pathan', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, India.'}, {'ForeName': 'Gerhild', 'Initials': 'G', 'LastName': 'Angyalosi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': 'Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Elborn', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Haworth', 'Affiliation': 'Cambridge Centre for Lung Infection, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The European respiratory journal,['10.1183/13993003.01451-2020']
1838,32855372,Buccal infiltration injection without a 4% articaine palatal injection for maxillary impacted third molar surgery.,"Objectives


Palatal infiltration is the most painful and uncomfortable anesthesia technique for maxillary impacted third molar surgery (MITMS). This approach could cause patients distress and aversion to dental treatment. The aim of this study was to evaluate the anesthetic efficacy of a buccal infiltration injection without a palatal injection in MITMS.
Materials and Methods


This prospective research study was a crossover split mouth-randomized controlled trial. Twenty-eight healthy symmetrical bilateral MITMS patients (mean age, 23 years) were randomly assigned to two groups. Buccal infiltration injections without palatal injections were designated as the study group and the buccal with palatal infiltration cases were the control group, using 4% articaine and 1:100,000 epinephrine. The operation started after 10 minutes of infiltration. Pain assessment was done using a visual analogue scale and a numeric rating scale after each injection and extraction procedure. Similarly, the success rate, hemodynamic parameters, and additional requested local anesthetic were assessed.
Results


The results showed that the pain associated with local anesthetic injections between both groups were significantly different. However, the success rates between the groups were not significantly different. Postoperative pain was not significant between both groups and a few patients requested an additional local anesthetic, but the results were not statistically significant. For hemodynamic parameters, there was a significant difference in systolic pressure during incision, bone removal, and tooth elevation. In comparison, during the incision stage there was a significant difference in diastolic pressure; however, other steps in the intervention were not significantly different between groups.
Conclusion


We concluded that buccal infiltration injection without palatal injection can be an alternative technique instead of the conventional injection for MITMS.",2020,"Postoperative pain was not significant between both groups and a few patients requested an additional local anesthetic, but the results were not statistically significant.","['Twenty-eight healthy symmetrical bilateral MITMS patients (mean age, 23 years', 'maxillary impacted third molar surgery']","['articaine palatal injection', 'buccal infiltration injection', 'articaine and 1:100,000 epinephrine']","['diastolic pressure', 'success rate, hemodynamic parameters, and additional requested local anesthetic', 'Pain assessment', 'visual analogue scale and a numeric rating scale', 'success rates', 'Postoperative pain', 'anesthetic efficacy', 'pain associated with local anesthetic injections', 'systolic pressure during incision, bone removal, and tooth elevation']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",28.0,0.061629,"Postoperative pain was not significant between both groups and a few patients requested an additional local anesthetic, but the results were not statistically significant.","[{'ForeName': 'Som', 'Initials': 'S', 'LastName': 'Sochenda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chakorn', 'Initials': 'C', 'LastName': 'Vorakulpipat', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kumar K', 'Initials': 'KK', 'LastName': 'C', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chavengkiat', 'Initials': 'C', 'LastName': 'Saengsirinavin', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manus', 'Initials': 'M', 'LastName': 'Rojvanakarn', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natthamet', 'Initials': 'N', 'LastName': 'Wongsirichat', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}]",Journal of the Korean Association of Oral and Maxillofacial Surgeons,['10.5125/jkaoms.2020.46.4.250']
1839,32856285,"Efficacy of Milrinone Plus Sildenafil in the Treatment of Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings: Results of a Randomized, Double-Blind Trial.","BACKGROUND


The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation.
OBJECTIVES


The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN.
METHODS


A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone.
RESULTS


Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality.
CONCLUSION


Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings.
REGISTRATION


Pan African Clinical Trial Registry identifier number PACTR201902691230243.",2020,The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups.,"['severe persistent pulmonary hypertension (PPHN', 'neonates with PPHN', 'neonates with severe PPHN', 'neonates with PPHN were divided into three groups of 20 patients each: group 1 received', 'Neonates with Persistent Pulmonary Hypertension in Resource-Limited Settings']","['sildenafil', 'sildenafil and milrinone', 'oral sildenafil starting at 0.5\xa0mg/kg every 6\xa0h to a target maintenance dose of 2\xa0mg/kg every 6\xa0h; group 2 received intravenous milrinone 0.5\xa0μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone', 'milrinone', 'Milrinone Plus Sildenafil']","['mortality', 'pulmonary artery systolic pressure', 'oxygenation index']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0128513', 'cui_str': 'Milrinone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}]",,0.401337,The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups.,"[{'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'El-Ghandour', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Bahaa', 'Initials': 'B', 'LastName': 'Hammad', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ghanem', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Manal A M', 'Initials': 'MAM', 'LastName': 'Antonios', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, El-Shatby Hospital, Alexandria University, Alexandria, Egypt. malakmanal@yahoo.com.'}]",Paediatric drugs,['10.1007/s40272-020-00412-4']
1840,32857301,Comparing outcomes of hospitalized patients with moderate and severe COVID-19 following treatment with hydroxychloroquine plus atazanavir/ritonavir.,"BACKGROUND


The role of the antiviral therapy in treatment of COVID-19 is still a matter to be investigated. Also efficacy and safety of antiviral regimens were not compared according severity of the disease. In this study the efficacy and safety of hydroxychloroquine plus atazanavir/ritonavir was compared in patients with moderate and severe COVID-19.
METHODS


We prospectively evaluated the clinical outcomes of 213 patients with COVID-19 during the hospitalization course and up to 56 days after the hospital discharge. The disease was categorized to moderate and severe based on the severity of pneumonia and peripheral oxygen saturation (SpO2). The patients received the national treatment protocol containing hydroxychloroquine (400 mg BD in first day and then 200 mg BD) plus atazanavir/ritonavir (300/100 mg daily) for 7 days. Main outcomes included discharge rates at day 7, 14 and 28, 28-day mortality, rate of intensive care unit (ICU) admission and intubation, length of hospital and ICU stay and incidence of adverse events.
RESULTS


The mean (SD) age of patients was 60(14) years and 53% were male. According to WHO definition, 51.64% and 48.36% of the patients had moderate (SpO2 ≥ 90%) and severe disease (SpO2 < 90%) at baseline, respectively. The discharge rate of the moderate group was significantly higher than the severe group at day 7, 14 and 28 (HR = 0.49; 95% CI: 0.35-0.69, p = < 0.001 at day 7, HR = 0.48; 95% CI: 0.35-0.66, p = < 0.001 at day 14 and HR = 0.49; 95% CI: 0.36-0.67, p = < 0.001at day 28). The 28-day mortality of the severe group was six times higher than the moderate group (HR = 6.00; 95% CI: 2.50-14.44), p = < 0.001). The need of admission in ICU for the severe group and the moderate group was 37.86% and 18.18% of the patients. Length of hospital stay was significantly shorter in the moderate group in comparison with the severe group (5 ± 4 vs. 8 ± 6 days, p < 0.001). Patients in the moderate group experienced the serious adverse events and complications less than the severe group. The discharged patients were followed up to 56 days after discharge. Some of the patients complained of symptoms such as exertional dyspnea, weakness and new-onset hair loss.
CONCLUSION


Our study did not support the use of hydroxychloroquine plus atazanavir/ritonavir in patients who had SpO 2  < 90% at the time of hospital admission. SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.",2020,"SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.","['hospitalized patients with moderate and severe COVID-19 following treatment with', 'The mean (SD) age of patients was 60(14) years and 53% were male', 'patients who had SpO 2 \u2009<\u200990% at the time of hospital admission', 'patients with moderate and severe COVID-19', '213 patients with COVID-19 during the hospitalization course and up to 56\xa0days after the hospital discharge']","['hydroxychloroquine', 'atazanavir/ritonavir', 'hydroxychloroquine plus atazanavir/ritonavir']","['serious adverse events and complications', 'discharge rate', 'efficacy and safety', 'Length of hospital stay', '28-day mortality', 'exertional dyspnea, weakness and new-onset hair loss', 'clinical outcomes (duration of hospital stay, discharge from the hospital and mortality', 'discharge rates at day 7, 14 and 28, 28-day mortality, rate of intensive care unit (ICU) admission and intubation, length of hospital and ICU stay and incidence of adverse events', 'severity of pneumonia and peripheral oxygen saturation (SpO2', 'severe disease']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",213.0,0.133007,"SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nabiee', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Setayesh', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. khalilih@tums.ac.ir.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hasannezhad', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ghaderkhani', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Imam Khomeini Hospital Complex, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public health, Tehran University of Medical Sciences, Tehran, Iran.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00369-2']
1841,32862760,Effect of renal denervation on catecholamines and the renin-angiotensin-aldosterone system.,"INTRODUCTION


The effect of renal sympathetic denervation (RDN) on neurohormonal responses is largely unknown. We aimed to assess the effect of RDN on the renin-angiotensin-aldosterone system (RAAS) and endogenous catecholamines.
METHODS


A total of 60 patients with hypertension underwent RDN and remained on a stable antihypertensive drug regimen. Samples for plasma aldosterone, plasma renin and urine (nor)metanephrine were collected at baseline and at 6 months post procedure. Ambulatory blood pressure (BP) recordings were obtained at baseline and at 6 months post procedure.
RESULTS


Mean age was 64±9 years, and 30/60 patients were male. At 6 months, average daytime systolic and diastolic ambulatory BP decreased by 10 and 6 mmHg, respectively ( p <0.001). No significant change was observed in plasma aldosterone (median=248.0 pmol/L (interquartile range (IQR) 113.3-369.5 pmol/L) vs. median=233.0 pmol/L (IQR 110.3-360.8 pmol/L);  p =0.66); renin (median=19.5 µIU/mL (IQR 6.8-119.5 µIU/mL) vs. median=14.3 µIU/mL (IQR 7.2-58.0 µIU/mL);  p =0.32), urine metanephrine (median=0.46 µmol/L (IQR 0.24-0.77 µmol/L) vs. median=0.46 µmol/L (IQR 0.22-0.88 µmol/L);  p =0.75) and normetanephrine (median=1.41 µmol/L (IQR 0.93-2.00 µmol/L vs. median =1.56 (IQR 0.74-2.50 µmol/L);  p =0.58) between baseline and 6 months, respectively. No correlation was found between the decrease in mean systolic daytime BP and changes in RAAS hormones or endogenous catecholamines.
CONCLUSION


Despite significant reductions in ambulatory BP, RDN did not result in a significant change in endogenous catecholamines or in RAAS hormones at 6 months.",2020,"Despite significant reductions in ambulatory BP, RDN did not result in a significant change in endogenous catecholamines or in RAAS hormones at 6 months.","['60 patients with hypertension underwent RDN and remained on a stable antihypertensive drug regimen', 'Mean age was 64±9 years, and 30/60 patients were male']","['RDN', 'renal sympathetic denervation (RDN']","['plasma aldosterone', 'normetanephrine', 'ambulatory BP, RDN', 'urine metanephrine', 'average daytime systolic and diastolic ambulatory BP', 'endogenous catecholamines or in RAAS hormones', 'mean systolic daytime BP and changes in RAAS hormones or endogenous catecholamines', 'Ambulatory blood pressure (BP) recordings', 'plasma aldosterone, plasma renin and urine (nor)metanephrine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}]","[{'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0028385', 'cui_str': 'Normetanephrine'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0039038', 'cui_str': 'Sympathectomy'}, {'cui': 'C0428374', 'cui_str': 'Metanephrines measurement, total, urine'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}]",60.0,0.0632837,"Despite significant reductions in ambulatory BP, RDN did not result in a significant change in endogenous catecholamines or in RAAS hormones at 6 months.","[{'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Feyz', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Centre, The Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'van den Berg', 'Affiliation': 'Department of Clinical Chemistry, Erasmus MC, University Medical Centre, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Zietse', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, University Medical Centre, The Netherlands.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Kardys', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Centre, The Netherlands.'}, {'ForeName': 'Jorie', 'Initials': 'J', 'LastName': 'Versmissen', 'Affiliation': 'Department of Internal Medicine, Erasmus MC, University Medical Centre, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Daemen', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Centre, The Netherlands.'}]",Journal of the renin-angiotensin-aldosterone system : JRAAS,['10.1177/1470320320943095']
1842,32863329,Hybrid Training System Improves Insulin Resistance in Patients with Nonalcoholic Fatty Liver Disease: A Randomized Controlled Pilot Study.,"Insulin resistance is associated with the progression of nonalcoholic fatty liver disease (NAFLD). Insulin resistance is regulated by various cytokines, including interleukin-6 (IL-6), a proinflammatory myokine, and selenoprotein P (SeP), a liver-derived secretory hepatokine. High levels of IL-6 and/or SeP have been shown to contribute to insulin resistance, and exercise is a first-line therapy for NAFLD. We have developed a hybrid training system (HTS): a neuromuscular electrical stimulation device to enhance exercise results. We aimed to investigate the effects of HTS on insulin resistance as well as serum IL-6 and SeP in patients with NAFLD. This is a randomized, single-blind (assessor), controlled trial. Subjects with NAFLD walked on a treadmill with or without HTS (9 subjects each) for 30 minutes three times a week for six weeks (HTS vs. control group; median age 45 vs. 45; male/female 5/4 vs. 6/3). We examined subjects before the first session and at the end of the final session. Serum SeP levels were measured by ELISA which measures the fragment of SeP. In the HTS group, HOMA-IR values were significantly reduced compared to the control group (Δ-0.71 vs. Δ0.05; P < 0.05). IL-6 and SeP levels in serum were also significantly reduced compared to that of the control group (IL-6; Δ-0.6 vs. Δ0.29 pg/mL; P < 0.05, SeP; Δ-1288.5 vs. Δ-435.4 ng/mL; P < 0.05, respectively). In conclusion, we propose that HTS improves insulin resistance by reducing serum IL-6 and SeP levels in patients with NAFLD.",2020,"IL-6 and SeP levels in serum were also significantly reduced compared to that of the control group (IL-6; Δ-0.6 vs. Δ0.29 pg/mL; P < 0.05, SeP; Δ-1288.5 vs. Δ-435.4 ng/mL; P < 0.05, respectively).","['patients with NAFLD', 'Patients with Nonalcoholic Fatty Liver Disease', 'Subjects with NAFLD walked on a']","['HTS', 'Hybrid Training System', 'treadmill with or without HTS', 'hybrid training system (HTS): a neuromuscular electrical stimulation device']","['Serum SeP levels', 'serum IL-6 and SeP', 'HOMA-IR values', 'serum IL-6 and SeP levels', 'Insulin Resistance', 'IL-6 and SeP levels', 'insulin resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0141947', 'cui_str': 'SelP Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",45.0,0.0609664,"IL-6 and SeP levels in serum were also significantly reduced compared to that of the control group (IL-6; Δ-0.6 vs. Δ0.29 pg/mL; P < 0.05, SeP; Δ-1288.5 vs. Δ-435.4 ng/mL; P < 0.05, respectively).","[{'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Iwanaga', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Ryuki', 'Initials': 'R', 'LastName': 'Hashida', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Takano', 'Affiliation': 'Department of Physical Therapy School of Health Sciences at Fukuoka, International University Health and Welfare.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Bekki', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nakano', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Omoto', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nago', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Matsuse', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Torimura', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Shiba', 'Affiliation': 'Division of Rehabilitation, Kurume University Hospital.'}]",The Tohoku journal of experimental medicine,['10.1620/tjem.252.23']
1843,32863330,Coparenting Intervention for Expectant Parents Affects Relationship Quality: A Pilot Study.,"Research has shown that the transition to parenthood is a particularly challenging period of life which is often associated with a decline in relationship quality and an increase in mental health problems. Emerging parents often experience difficulties in coping with new tasks and challenges in the relationship, resulting in inadequate mutual support, stress, conflicts and even depressive symptoms. To support expectant parents in establishing an effective and strong coparenting alliance, we have employed an educational coparenting intervention to teach important coparenting skills. The intervention was a non-randomized case-control study with 126 expectant parents. The intervention group participated in a five-session intervention, whereas the control group received an information booklet and had an optional meeting postpartum. The purpose of this study was to ease the transition to parenthood in order to prevent postpartum conflict and depression. Parents in the intervention group (n = 34 couples) showed significantly fewer conflicts postpartum than before (Z = -3.28, p = 0.00), and scored better in postnatal delegated dyadic coping (β = 0.25, p = 0.00, R 2  = 0.32), a form of mutual support. Neither the intervention group (Z = -0.83, p = 0.40) nor the control group (Z = -0.86, p = 0.38) showed a significant increase in depression scores after childbirth. Although conflicts during the transition to parenthood declined and postnatal delegated dyadic coping strengthened, the study design does not allow to draw conclusion on group effects. Nevertheless, the promising results of this pilot intervention are a base for future studies.",2020,"Neither the intervention group (Z = -0.83, p = 0.40) nor the control group (Z = -0.86, p = 0.38) showed a significant increase in depression scores after childbirth.",['126 expectant parents'],"['control group received an information booklet and had an optional meeting postpartum', 'Coparenting Intervention']","['conflicts postpartum', 'depression scores']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",126.0,0.0325264,"Neither the intervention group (Z = -0.83, p = 0.40) nor the control group (Z = -0.86, p = 0.38) showed a significant increase in depression scores after childbirth.","[{'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Philipp', 'Affiliation': 'Department for Psychoanalysis and Psychotherapy, Medical University of Vienna.'}, {'ForeName': 'Jin-Kyung', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Edna Bennett Pierce Prevention Research Center, Pennsylvania State University.'}, {'ForeName': 'Tanja A', 'Initials': 'TA', 'LastName': 'Stamm', 'Affiliation': 'Section for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wininger', 'Affiliation': 'Research Unit Psychoanalysis and Education of the Department of Education, University of Vienna.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Datler', 'Affiliation': 'Research Unit Psychoanalysis and Education of the Department of Education, University of Vienna.'}, {'ForeName': 'Nestor D', 'Initials': 'ND', 'LastName': 'Kapusta', 'Affiliation': 'Department for Psychoanalysis and Psychotherapy, Medical University of Vienna.'}]",The Tohoku journal of experimental medicine,['10.1620/tjem.252.33']
1844,32868311,Effects of carbohydrate quality and amount on plasma lactate: results from the OmniCarb trial.,"INTRODUCTION


Plasma lactate is a marker of non-oxidative glucose metabolism associated with progression to diabetes. We examined the effect of carbohydrate quality (glycemic index (GI)) and amount (%kcal) on plasma lactate. We hypothesized that low GI (≤45 (g)) versus high (≥65 (G)) and low %kcal from carbohydrate (40% kcal (c)) versus high (58% kcal (C)) each would reduce lactate levels.
RESEARCH DESIGN AND METHODS


We measured lactate in OmniCarb, a randomized, cross-over trial of four diets in overweight/obese adults without diabetes or cardiovascular disease (N=163). The four diets were high carbohydrate+high GI (CG, reference), high carbohydrate+low GI (Cg), low carbohydrate+high GI (cG), and low carbohydrate+low GI (cg). Participants (N=163) consumed each of the four diets over a 5-week period, separated by 2-week washout periods. Plasma lactate levels were measured at baseline, during which the participants consumed their own diets, and after each 5-week period.
RESULTS


Baseline plasma lactate was 1.2 mmol/L. In the setting of high carbohydrate amount, reducing GI lowered plasma lactate non-significantly by 0.08 mmol/L (Cg vs CG: 95% CI -0.16 to 0.00; p=0.06). In the setting of high GI, reducing carbohydrate amount lowered plasma lactate by 0.10 mmol/L (cG vs CG: 95% CI -0.19 to -0.02; p=0.02). The combined effect of reducing GI and carbohydrate proportion in the diet (cg vs CG) was similar (cg vs CG: -0.08; 95% CI -0.16 to 0.00; p=0.04). All four diets reduced plasma lactate compared with baseline.
CONCLUSIONS


Compared with a diet with high GI and high carbohydrate amount, diets with low GI and/or low carbohydrate amount reduced plasma lactate. Whether this change in lactate leads to long-term change in glucose metabolism needs to be examined.
TRIAL REGISTRATION NUMBER


NCT00608049.",2020,"In the setting of high carbohydrate amount, reducing GI lowered plasma lactate non-significantly by 0.08 mmol/L",['overweight/obese adults without diabetes or cardiovascular disease (N=163'],[],"['high carbohydrate+high\u2009GI (CG, reference), high carbohydrate+low\u2009GI (Cg), low carbohydrate+high\u2009GI (cG), and low carbohydrate+low\u2009GI (cg', 'Plasma lactate levels', 'plasma lactate', 'carbohydrate quality (glycemic index (GI', 'GI lowered plasma lactate', 'GI and carbohydrate proportion', 'Baseline plasma lactate']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1272145', 'cui_str': 'Plasma lactate level'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",163.0,0.0512758,"In the setting of high carbohydrate amount, reducing GI lowered plasma lactate non-significantly by 0.08 mmol/L","[{'ForeName': 'Jiun-Ruey', 'Initials': 'JR', 'LastName': 'Hu', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Yingfei', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard University T H Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller Iii', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'J Hunter', 'Initials': 'JH', 'LastName': 'Young', 'Affiliation': 'Welch Center for Epidemiology, Prevention, and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA sjurasch@bidmc.harvard.edu.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001457']
1845,32846762,Efficacy of music-based cognitive behavior therapy on the management of test-taking behavior of children in basic science using a randomized trial group: Implication for community development.,"BACKGROUND


This study sought the efficacy of cognitive-behavioral therapy-based music group (CBT-Music) intervention program on primary school children's test-taking behavior in Southeast Nigeria.
METHODS


A pretest, posttest randomized controlled trial experimental design was adopted for the study using a sample of 53 primary three (3) children. A test-taking behavior questionnaire was used for data collection. The instrument was face validated by test development experts. Construct validation of the instrument was done by subjecting the instrument to factor analysis after trial testing. Data were analyzed using independent samples t-test and paired samples t-test.
RESULTS


The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children. Furthermore, the test-taking scores of children in the music-based CBT group were significantly lower than those in the control group at the follow-up measure. This implies that the test-taking behavior of the children can be better managed using the CBT-music intervention program to enable the children to grow better academically and contribute to the community they belong to.
CONCLUSION


Music-based CBT demonstrated significant efficacy in the management of children's test-taking behavior. Thus, primary school teachers should be enlightened on how to make use of CBT-Music in the management of test-taking behavior among children.",2020,The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children.,"['primary school teachers', ""primary school children's test-taking behavior in Southeast Nigeria"", 'sample of 53 primary three (3) children']","['cognitive-behavioral therapy-based music group (CBT-Music) intervention program', 'Music-based CBT', 'music-based cognitive behavior therapy']",[],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0871510', 'cui_str': 'Test-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],3.0,0.0285278,The findings of the study revealed that CBT-Music had a significant effect on the management of test-taking behavior of among children.,"[{'ForeName': 'Matthias U', 'Initials': 'MU', 'LastName': 'Agboeze', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Chinedu I O', 'Initials': 'CIO', 'LastName': 'Okeke', 'Affiliation': 'School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Gloria C', 'Initials': 'GC', 'LastName': 'Ugwu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Chizoba L', 'Initials': 'CL', 'LastName': 'Obikwelu', 'Affiliation': 'Department of Educational Foundations, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Obiozor', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'Dorida N', 'Initials': 'DN', 'LastName': 'Oyigbo', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mbam', 'Affiliation': 'Department of Adult Education and Extra-Mural Studies, Faculty of Education, University of Nigeria, Nsukka, Nigeria.'}]",Medicine,['10.1097/MD.0000000000021535']
1846,32846766,Comparison of tendon suture fixation and cortical screw fixation for treatment of distal tibiofibular syndesmosis injury: A case-control study.,"This study aimed to investigate the effectiveness of tendon suture fixation versus cortical screw fixation for the treatment of distal tibiofibular syndesmosis injury.This study recruited 42 patients with Danis-Weber type B, C1 and C2 fractures concomitant with lower tibiofibular syndesmosis injury, who were randomly assigned to 2 groups according to treatment with cortical screw fixation (n = 21) and tendon suture fixation (n = 21). Operation time, intraoperative blood loss, time to full weight-bearing activity, medical cost, ankle function, and ankle pain were compared between the 2 groups.The operation time was significantly less with cortical screw fixation (57.1 ± 5.3 min) than with tendon suture fixation (63.3 ± 6.3 min; p = 0.01), but there was no significant difference in intraoperative blood loss. The time until full weight-bearing was possible was significantly longer after cortical screw fixation (10.9 ± 2.7 weeks) than after tendon suture fixation (7.1 ± 1.9 weeks; P < .001). The medical cost was much greater for cortical screw fixation (1861.6 ± 187.3 USD) than for tendon suture fixation (1209.6 ± 97.6 USD; P < .01). The rate of excellent and good ankle function at 3 months after surgery was significantly higher with tendon suture fixation (71.4%) than with cortical screw fixation (33.3%; P = .03).Tendon suture fixation is associated with quicker recovery of ankle function, shorter time to full weight-bearing, and lower medical cost to the patient compared with screw fixation. Our findings suggest that tendon suture fixation is an effective method for the treatment of tibiofibular syndesmosis injury.",2020,"suture fixation is associated with quicker recovery of ankle function, shorter time to full weight-bearing, and lower medical cost to the patient compared with screw fixation.","['distal tibiofibular syndesmosis injury', '42 patients with Danis-Weber type B, C1 and C2 fractures concomitant with lower tibiofibular syndesmosis injury']","['tendon suture fixation and cortical screw fixation', '03).Tendon', 'suture fixation', 'tendon suture fixation versus cortical screw fixation', 'cortical screw fixation', 'cortical screw fixation (n\u200a=\u200a21) and tendon suture fixation', 'tendon suture fixation']","['rate of excellent and good ankle function', 'Operation time, intraoperative blood loss, time to full weight-bearing activity, medical cost, ankle function, and ankle pain', 'medical cost', 'intraoperative blood loss', 'time until full weight-bearing', 'operation time', 'cortical screw fixation']","[{'cui': 'C0730182', 'cui_str': 'Distal tibiofibular joint structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582525', 'cui_str': 'weber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0730180', 'cui_str': 'Tibiofibular joint structure'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]",42.0,0.0263796,"suture fixation is associated with quicker recovery of ankle function, shorter time to full weight-bearing, and lower medical cost to the patient compared with screw fixation.","[{'ForeName': 'Liuhong', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Zhifu', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'Zhongqiang', 'Initials': 'Z', 'LastName': 'Kuang', 'Affiliation': ''}, {'ForeName': 'Shiyan', 'Initials': 'S', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Fang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021573']
1847,32847444,Clinical effect of Changweishu on gastrointestinal dysfunction in patients with sepsis.,"OBJECTIVE


To investigate Changweishu's clinical effect on gastrointestinal dysfunction in patients with sepsis.
METHODS


Fifty patients with gastrointestinal dysfunction and sepsis were randomly divided into treatment and control groups. The control group patients received routine Western medicine treatments (meropenem, noradrenaline, glutamine glue,  Bifidobacterium lactis  triple-strain tablet), and the treatment group patients received routine Western medicine treatment combined with Changweishu. Treatments in both groups lasted 7 days. Changes in APACHE II score, gastrointestinal dysfunction score, serum levels of diamine oxidase (DAO), D-lactic acid, inflammatory factors (tumor necrosis factor (TNF)-α, interleukin (IL)-6, and high-mobility group box 1 (HMGB-1)), and the incidence of multiple organ dysfunction syndrome (MODS) and mortality were observed.
RESULTS


After treatment, APACHE II score, gastrointestinal dysfunction score, and DAO, D-lactic acid, TNF-α, IL-6, and HMGB-1 levels decreased significantly in both groups, but the decrease was more significant in the treatment group than in the control group. The incidence of MODS and mortality were significantly lower in the treatment group than in the control group.
CONCLUSION


The addition of Changweishu to routine Western treatments can improve gastrointestinal function in patients with sepsis and gastrointestinal dysfunction, as well as decreasing the incidence of MODS and mortality and improving patient prognosis.",2020,"The addition of Changweishu to routine Western treatments can improve gastrointestinal function in patients with sepsis and gastrointestinal dysfunction, as well as decreasing the incidence of MODS and mortality and improving patient prognosis.","['patients with sepsis', 'Fifty patients with gastrointestinal dysfunction and sepsis', 'patients with sepsis and gastrointestinal dysfunction']","['routine Western medicine treatment combined with Changweishu', 'routine Western medicine treatments (meropenem, noradrenaline, glutamine glue,  Bifidobacterium lactis  triple-strain tablet']","['gastrointestinal function', 'APACHE II score, gastrointestinal dysfunction score, and DAO, D-lactic acid, TNF-α, IL-6, and HMGB-1 levels', 'incidence of MODS and mortality', 'Changes in APACHE II score, gastrointestinal dysfunction score, serum levels of diamine oxidase (DAO), D-lactic acid, inflammatory factors (tumor necrosis factor (TNF)-α, interleukin (IL)-6, and high-mobility group box 1 (HMGB-1)), and the incidence of multiple organ dysfunction syndrome (MODS) and mortality', 'gastrointestinal dysfunction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0066005', 'cui_str': 'meropenem'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023139', 'cui_str': 'Lauric acid'}, {'cui': 'C3658295', 'cui_str': 'Propanoic Acid, 2-Hydroxy-, (2R)-'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0949597', 'cui_str': 'HMG-B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019587', 'cui_str': 'Amine oxidase (copper-containing)'}, {'cui': 'C0019796', 'cui_str': 'HMG-1 Protein'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}]",50.0,0.0141974,"The addition of Changweishu to routine Western treatments can improve gastrointestinal function in patients with sepsis and gastrointestinal dysfunction, as well as decreasing the incidence of MODS and mortality and improving patient prognosis.","[{'ForeName': 'Fen-Qiao', 'Initials': 'FQ', 'LastName': 'Chen', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Wen-Zhong', 'Initials': 'WZ', 'LastName': 'Xu', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Hai-Yun', 'Initials': 'HY', 'LastName': 'Gao', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Wu', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Jian-Qiang', 'Initials': 'JQ', 'LastName': 'Mei', 'Affiliation': 'Emergency Department, Hebei Provincial Hospital of traditional Chinese Medicine, Shijiazhuang, Hebei, China.'}]",The Journal of international medical research,['10.1177/0300060520919579']
1848,32851871,A 12-Week Multi-Modal Exercise Program: Feasibility of Combined Exercise and Simplified 8-Style Tai Chi Following Lung Cancer Surgery.,"OBJECTIVE


To assess the feasibility, safety, and preliminary effect of a 12-week multi-modal rehabilitation program targeted at improving health-related quality of life and physical activity levels of patients with lung cancer following treatment.
METHODS


Patients with stage I to IIIA non-small cell lung cancer were included 6 to 12 weeks following completion of treatment. The intervention comprised of aerobic exercise (brisk walking), resistance training and 8-style Tai Chi. The 12-week program included 2 supervised center-based sessions per week of 90 minutes duration and home-based exercise. The primary outcomes were the feasibility and safety of the intervention. Secondary outcomes (assessed pre and post program) were physical and patient-reported outcomes.
RESULTS


Seventy-eight patients were approached during the 6-month recruitment period and 17 (22%) consented to the study. Eight participants (47%) met the definition of adherence to the program (attending at least 70% of supervised sessions). No serious adverse events occurred. A significant reduction in anxiety and depression was observed post-program. In addition, improvements in respiratory function, sleep quality, and some health-related quality of life domains were observed post-program. There were no significant differences in functional capacity or physical activity levels.
CONCLUSION


This multi-modal exercise training program was safe, although the feasibility of the program in its current state is not supported given the low consent rate and low adherence to the intervention.",2020,"There were no significant differences in functional capacity or physical activity levels.
","['Patients with stage I to IIIA non-small cell lung cancer', 'patients with lung cancer following treatment', 'Lung Cancer Surgery', 'Seventy-eight patients were approached during the 6-month recruitment period and 17 (22%) consented to the study']","['supervised center-based sessions per week of 90\u2009minutes duration and home-based exercise', 'multi-modal rehabilitation program', 'Combined Exercise and Simplified 8-Style Tai Chi', 'aerobic exercise (brisk walking), resistance training and 8-style Tai Chi']","['respiratory function, sleep quality, and some health-related quality of life domains', 'health-related quality of life and physical activity levels', 'feasibility and safety', 'functional capacity or physical activity levels', 'anxiety and depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",78.0,0.0423315,"There were no significant differences in functional capacity or physical activity levels.
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Lu', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Denehy', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Yuejiao', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Qirui', 'Initials': 'Q', 'LastName': 'Cong', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Granger', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Affiliated Hospital of Nantong University, Nantong, Jiangsu, China.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Edbrooke', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}]",Integrative cancer therapies,['10.1177/1534735420952887']
1849,32853410,Interventions for American cutaneous and mucocutaneous leishmaniasis.,"BACKGROUND


On the American continent, cutaneous and mucocutaneous leishmaniasis (CL and MCL) are diseases associated with infection by several species of Leishmania parasites. Pentavalent antimonials remain the first-choice treatment. There are alternative interventions, but reviewing their effectiveness and safety is important as availability is limited. This is an update of a Cochrane Review first published in 2009.
OBJECTIVES


To assess the effects of interventions for all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML).
SEARCH METHODS


We updated our database searches of the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and CINAHL to August 2019. We searched five trials registers.
SELECTION CRITERIA


Randomised controlled trials (RCTs) assessing either single or combination treatments for ACML in immuno-competent people, diagnosed by clinical presentation and Leishmania infection confirmed by smear, culture, histology, or polymerase chain reaction on a biopsy specimen. The comparators were either no treatment, placebo only, or another active compound.
DATA COLLECTION AND ANALYSIS


We used standard methodological procedures expected by Cochrane. Our key outcomes were the percentage of participants 'cured' at least three months after the end of treatment, adverse effects, and recurrence. We used GRADE to assess evidence certainty for each outcome.
MAIN RESULTS


We included 75 studies (37 were new), totalling 6533 randomised participants with ATL. The studies were mainly conducted in Central and South America at regional hospitals, local healthcare clinics, and research centres. More male participants were included (mean age: roughly 28.9 years (SD: 7.0)). The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana. The most assessed interventions and comparators were non-antimonial systemics (particularly oral miltefosine) and antimonials (particularly meglumine antimoniate (MA), which was also a common intervention), respectively. Three studies included moderate-to-severe cases of mucosal leishmaniasis but none included cases with diffuse cutaneous or disseminated CL, considered the severe cutaneous form. Lesions were mainly ulcerative and located in the extremities and limbs. The follow-up (FU) period ranged from 28 days to 7 years. All studies had high or unclear risk of bias in at least one domain (especially performance bias). None of the studies reported the degree of functional or aesthetic impairment, scarring, or quality of life. Compared to placebo, at one-year FU, intramuscular (IM) MA given for 20 days to treat L. braziliensis and L. panamensis infections in ACML may increase the likelihood of complete cure (risk ratio (RR) 4.23, 95% confidence interval (CI) 0.84 to 21.38; 2 RCTs, 157 participants; moderate-certainty evidence), but may also make little to no difference, since the 95% CI includes the possibility of both increased and reduced healing (cure rates), and IMMA probably increases severe adverse effects such as myalgias and arthralgias (RR 1.51, 95% CI 1.17 to 1.96; 1 RCT, 134 participants; moderate-certainty evidence). IMMA may make little to no difference to the recurrence risk, but the 95% CI includes the possibility of both increased and reduced risk (RR 1.79, 95% CI 0.17 to 19.26; 1 RCT, 127 participants; low-certainty evidence). Compared to placebo, at six-month FU, oral miltefosine given for 28 days to treat L. mexicana, L. panamensis and L. braziliensis infections in American cutaneous leishmaniasis (ACL) probably improves the likelihood of complete cure (RR 2.25, 95% CI 1.42 to 3.38), and probably increases nausea rates (RR 3.96, 95% CI 1.49 to 10.48) and vomiting (RR 6.92, 95% CI 2.68 to 17.86) (moderate-certainty evidence). Oral miltefosine may make little to no difference to the recurrence risk (RR 2.97, 95% CI 0.37 to 23.89; low-certainty evidence), but the 95% CI includes the possibility of both increased and reduced risk (all based on 1 RCT, 133 participants). Compared to IMMA, at 6 to 12 months FU, oral miltefosine given for 28 days to treat L. braziliensis, L. panamensis, L. guyanensis and L. amazonensis infections in ACML may make little to no difference to the likelihood of complete cure (RR 1.05, 95% CI 0.90 to 1.23; 7 RCTs, 676 participants; low-certainty evidence). Based on moderate-certainty evidence (3 RCTs, 464 participants), miltefosine probably increases nausea rates (RR 2.45, 95% CI 1.72 to 3.49) and vomiting (RR 4.76, 95% CI 1.82 to 12.46) compared to IMMA. Recurrence risk was not reported. For the rest of the key comparisons, recurrence risk was not reported, and risk of adverse events could not be estimated. Compared to IMMA, at 6 to 12 months FU, oral azithromycin given for 20 to 28 days to treat L. braziliensis infections in ACML probably reduces the likelihood of complete cure (RR 0.51, 95% CI 0.34 to 0.76; 2 RCTs, 93 participants; moderate-certainty evidence). Compared to intravenous MA (IVMA) and placebo, at 12 month FU, adding topical imiquimod to IVMA, given for 20 days to treat L. braziliensis, L. guyanensis and L. peruviana infections in ACL probably makes little to no difference to the likelihood of complete cure (RR 1.30, 95% CI 0.95 to 1.80; 1 RCT, 80 participants; moderate-certainty evidence). Compared to MA, at 6 months FU, one session of local thermotherapy to treat L. panamensis and L. braziliensis infections in ACL reduces the likelihood of complete cure (RR 0.80, 95% CI 0.68 to 0.95; 1 RCT, 292 participants; high-certainty evidence). Compared to IMMA and placebo, at 26 weeks FU, adding oral pentoxifylline to IMMA to treat CL (species not stated) probably makes little to no difference to the likelihood of complete cure (RR 0.86, 95% CI 0.63 to 1.18; 1 RCT, 70 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS


Evidence certainty was mostly moderate or low, due to methodological shortcomings, which precluded conclusive results. Overall, both IMMA and oral miltefosine probably result in an increase in cure rates, and nausea and vomiting are probably more common with miltefosine than with IMMA. Future trials should investigate interventions for mucosal leishmaniasis and evaluate recurrence rates of cutaneous leishmaniasis and its progression to mucosal disease.",2020,"The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana.","['all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML', 'More male participants were included (mean age: roughly 28.9 years (SD: 7.0', '75 studies (37 were new), totalling 6533 randomised participants with ATL', 'American cutaneous and mucocutaneous leishmaniasis']","['IMMA', 'FU, intramuscular (IM) MA', 'Oral miltefosine', 'azithromycin', 'IMMA and placebo', 'placebo', 'intravenous MA (IVMA) and placebo', 'miltefosine']","['degree of functional or aesthetic impairment, scarring, or quality of life', 'recurrence risk', 'reduced healing (cure rates', 'vomiting', 'cure rates, and nausea and vomiting', 'likelihood of complete cure', 'Recurrence risk', 'nausea rates', 'adverse effects, and recurrence']","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1328252', 'cui_str': 'American mucocutaneous leishmaniasis'}, {'cui': 'C1292772', 'cui_str': 'Atypical chronic myeloid leukemia, BCR/ABL negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",6533.0,0.246987,"The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana.","[{'ForeName': 'Mariona', 'Initials': 'M', 'LastName': 'Pinart', 'Affiliation': 'Free time independent Cochrane reviewer, Berlin, Germany.'}, {'ForeName': 'José-Ramón', 'Initials': 'JR', 'LastName': 'Rueda', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of the Basque Country, Leioa, Spain.'}, {'ForeName': 'Gustavo As', 'Initials': 'GA', 'LastName': 'Romero', 'Affiliation': 'Center for Tropical Medicine, University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Pinzón-Flórez', 'Affiliation': 'Research Centre for Insurance Medicine, Keralty, Bogotá, Colombia.'}, {'ForeName': 'Karime', 'Initials': 'K', 'LastName': 'Osorio-Arango', 'Affiliation': 'Dirección de Redes en Salud Pública, Instituto Nacional de Salud, Bogotá, Colombia.'}, {'ForeName': 'Ana Nilce', 'Initials': 'AN', 'LastName': 'Silveira Maia-Elkhoury', 'Affiliation': 'Communicable Diseases and Environmental Determinants of Health (CDE), Neglected, Tropical and Vector Borne Diseases (VT), Pan American Health Organization/ World Health Organization (PAHO/WHO), Rio de Janeiro, Brazil.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Reveiz', 'Affiliation': 'Evidence and Intelligence for Action in Health Department, Pan American Health Organization (PAHO), Washington DC, USA.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Elias', 'Affiliation': 'Evidence and Intelligence for Action in Health Department, Pan American Health Organization (PAHO), Washington DC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Tweed', 'Affiliation': 'c/o Cochrane Skin Group, The University of Nottingham, Nottingham, UK.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD004834.pub3']
1850,32853584,"Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial.","BACKGROUND


Patients with immune thrombocytopenia are at risk of bleeding during surgery, and intravenous immunoglobulin is commonly used to increase the platelet count. We aimed to establish whether perioperative eltrombopag was non-inferior to intravenous immunoglobulin.
METHODS


We did a randomised, open-label trial in eight academic hospitals in Canada. Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100 × 10 9  cells per L before major surgery or less than 50 × 10 9  cells per L before minor surgery. Previous intravenous immunoglobulin within 2 weeks or thrombopoietin receptor agonists within 4 weeks before randomisation were not permitted. Patients were randomly assigned to receive oral daily eltrombopag 50 mg from 21 days preoperatively to postoperative day 7 or intravenous immunoglobulin 1 g/kg or 2 g/kg 7 days before surgery. Eltrombopag dose adjustments were allowed weekly based on platelet counts. The randomisation sequence was generated by a computerised random number generator, concealed and stratified by centre and surgery type (major or minor). The central study statistician was masked to treatment allocation. The primary outcome was achievement of perioperative platelet count targets (90 × 10 9  cells per L before major surgery or 45 × 10 9  cells per L before minor surgery) without rescue treatment. We did intention-to-treat and per-protocol analyses using an absolute non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov, NCT01621204.
FINDINGS


Between June 5, 2013, and March 7, 2019, 92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to eltrombopag and 36 to intravenous immunoglobulin. Median follow-up was 50 days (IQR 49-55). By intention-to-treat analysis, perioperative platelet targets were achieved for 30 (79%) of 38 patients assigned to eltrombopag and 22 (61%) of 36 patients assigned to intravenous immunoglobulin (absolute risk difference 17·8%, one-sided lower limit of the 95% CI 0·4%; p non-inferiority =0·005). In the per-protocol analysis, perioperative platelet targets were achieved for 29 (78%) of 37 patients in the eltrombopag group and 20 (63%) of 32 in the intravenous immunoglobulin group (absolute risk difference 15·9%, one-sided lower limit of the 95% CI -2·1%; p non-inferiority =0·009). Two serious adverse events occurred in the eltrombopag group: one treatment-related pulmonary embolism and one vertigo. Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery. No treatment-related deaths occurred.
INTERPRETATION


Eltrombopag is an effective alternative to intravenous immunoglobulin for perioperative treatment of immune thrombocytopenia. However, treatment with eltrombopag might increase risk of thrombosis. The decision to choose one treatment over the other will depend on patient preference, resource limitations, cost, and individual risk profiles.
FUNDING


GlaxoSmithKline and Novartis.",2020,"Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery.","['Patients with immune thrombocytopenia', 'eight academic hospitals in Canada', 'patients with immune thrombocytopenia', '92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to', 'Between June 5, 2013, and March 7, 2019', 'Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100\u2008×\u200810 9  cells per L before major surgery or less than 50\u2008×\u200810 9  cells per L before minor surgery']","['oral daily eltrombopag', 'eltrombopag and 36 to intravenous immunoglobulin', 'Perioperative oral eltrombopag', 'intravenous immunoglobulin', 'immunoglobulin', 'Eltrombopag', 'eltrombopag', 'perioperative eltrombopag']","['atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy', 'achievement of perioperative platelet count targets', 'risk of thrombosis', 'adverse events', 'pulmonary embolism and one vertigo', 'perioperative platelet targets']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038904', 'cui_str': 'Minor Surgical Procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}]","[{'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0406670', 'cui_str': 'Vulvodynia'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",92.0,0.259546,"Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery.","[{'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Arnold', 'Affiliation': 'Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada; Canadian Blood Services, Ancaster, ON, Canada. Electronic address: arnold@mcmaster.ca.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Heddle', 'Affiliation': 'Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Cook', 'Affiliation': 'Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Hsia', 'Affiliation': 'Department of Medicine, Division of Hematology, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Blostein', 'Affiliation': 'Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Jamula', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sholzberg', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Kassis', 'Affiliation': 'Faculty of Medicine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Loree', 'Initials': 'L', 'LastName': 'Larratt', 'Affiliation': 'Division of Hematology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Tinmouth', 'Affiliation': 'Department of Medicine, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Sufia', 'Initials': 'S', 'LastName': 'Amini', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, The Hague, Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schipperus', 'Affiliation': 'Department of Hematology, HagaZiekenhuis, The Hague, Netherlands; Department of Hematology, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Vishnu', 'Affiliation': 'Division of Hematology, Mayo Clinic College of Medicine, Jacksonville, FL, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Warner', 'Affiliation': 'McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Carruthers', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Kelton', 'Affiliation': 'Michael G DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, ON, Canada; Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30227-1']
1851,32856410,The efficiency of vein viewing on pain and anxiety of children during peripheral cannula intervention: A randomized controlled study.,"AIM


The purpose of this research is to estimate the efficiency of vein viewing device on 9-12 year-old children's pain and anxiety.
METHODS


The research has been designed as an experimental study including pre-and post-test and control groups. Data were collected with personal information form, facial expressions rating scale, state anxiety scale, vein viewing device and a peripheral cannula. Both groups were applied to the state anxiety scale before and after the procedure while the facial expressions rating scale was applied during the procedure.
RESULTS


Statistically significant difference was found between experimental and control groups regarding processing time, number of transaction attempts and facial expressions rating scale score averages. While there was no difference regarding the state anxiety scales average points of children in experimental and control groups before the procedure, a statistically significant difference was found in an advanced level regarding post-processing state anxiety levels.
CONCLUSIONS


Usage of vein viewing device during peripheral cannula intervention reduces children's pain and anxiety levels and shortens the durations of the initiative.",2020,"Statistically significant difference was found between experimental and control groups regarding processing time, number of transaction attempts and facial expressions rating scale score averages.","[""9-12\u2009year-old children's pain and anxiety"", 'children during peripheral cannula intervention']","['vein viewing device', 'vein viewing', 'peripheral cannula intervention']","['state anxiety scales', 'pain and anxiety', 'facial expressions rating scale', ""children's pain and anxiety levels"", 'facial expressions rating scale, state anxiety scale, vein viewing device and a peripheral cannula', 'processing time, number of transaction attempts and facial expressions rating scale score averages', 'state anxiety scale']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0249999,"Statistically significant difference was found between experimental and control groups regarding processing time, number of transaction attempts and facial expressions rating scale score averages.","[{'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Bayram', 'Affiliation': 'Zonguldak Bülent Ecevit University, Health Application and Research Center, Zonguldak, Turkey.'}, {'ForeName': 'Aysel', 'Initials': 'A', 'LastName': 'Topan', 'Affiliation': 'Zonguldak Bulent Ecevit University, Faculty of Health Sciences, Dept. of Nursing, Zonguldak, Turkey.'}]",Japan journal of nursing science : JJNS,['10.1111/jjns.12364']
1852,32857481,Effect of menopausal hormone therapy on proteins associated with senescence and inflammation.,"BACKGROUND


Estrogen may inhibit cell senescence that contributes to age-related disorders. This study determined the effects of menopausal hormone treatments on circulating levels of markers of cell senescence.
METHODS


Growth differentiation factor 15 (GDF15), tumor necrosis factor receptor 1 (TNFR1), FAS, and macrophage inflammatory protein 1α (MIP1α) were measured in serum using multiplexed bead-based assays and compared among menopausal women participating in the Kronos Early Estrogen Prevention Study randomized to either placebo (n = 38), oral conjugated equine estrogen (oCEE, n = 37), or transdermal 17β-estradiol (tE2, n = 34). Serum levels of the senescent markers for each treatment were compared to placebo 36 months after randomization using the Wilcoxon rank sum test.
RESULTS


Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo. The difference in levels between treatment and placebo for GDF15, TNFR1, and FAS were greater for oCEE [-108 pg/mL (p = .008), -234 pg/mL (p = .0006), and -1374 pg/mL (p < .0001), respectively] than for tE2 [-76 pg/mL (p = .072), -105 pg/mL (p = .076), and -695 pg/mL (p = .036), respectively]. Additionally, TNFR1 showed a positive association with time past menopause (correlation = 0.255, p = .019).
CONCLUSIONS


Circulating levels of some markers of cell senescence were lower in menopausal women treated with oCEE and tE2 compared to placebo. Differences in the magnitude of effect of the two active treatments may reflect the differences in circulating levels of estrogen metabolites due to formulation and mode of delivery. These data generate new hypotheses with regard to the effects of menopause on the biology of aging.",2020,"RESULTS


Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo.",['menopausal women participating in the Kronos Early Estrogen Prevention Study randomized to either'],"['TNFR1', 'placebo', 'menopausal hormone therapy', 'oCEE', 'oral conjugated equine estrogen (oCEE, n\xa0=\xa037), or transdermal 17β-estradiol', 'menopausal hormone treatments']","['GDF15, TNFR1, and FAS', 'Serum levels', 'cell senescence', 'Serum levels of GDF15, TNFR1, and FAS', 'senescence and inflammation', 'Growth differentiation factor 15 (GDF15), tumor necrosis factor receptor 1 (TNFR1), FAS, and macrophage inflammatory protein 1α (MIP1α', 'circulating levels of markers of cell senescence']","[{'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007581', 'cui_str': 'Senescence, Cellular'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.255534,"RESULTS


Serum levels of GDF15, TNFR1, and FAS, but not MIP1α, were lower in both the oCEE and tE2 groups compared to placebo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Faubion', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'White', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brett J', 'Initials': 'BJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Geske', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nathan K', 'Initials': 'NK', 'LastName': 'LeBrasseur', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Schafer', 'Affiliation': 'Robert and Arlene Kogod Center on Aging, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Mielke', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}]",Physiological reports,['10.14814/phy2.14535']
1853,32858229,A multi-modal virtual reality treadmill intervention for enhancing mobility and cognitive function in people with multiple sclerosis: Protocol for a randomized controlled trial.,"BACKGROUND


Gait and cognitive impairments are common in individuals with Multiple Sclerosis (MS) and can interfere with everyday function. Those with MS have difficulties executing cognitive tasks and walking simultaneously, a reflection of dual-task interference. Therefore, dual-task training may improve functional ambulation. Additionally, using technology such as virtual reality can provide personalized rehabilitation while mimicking real-world environments. The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms compared to conventional treadmill training.
METHODS


This study will be a single-blinded, two arm RCT with a six-week intervention period. 144 people with MS will be randomized into a treadmill training alone group or treadmill training with virtual reality group. Both groups will receive 18 sessions of training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system. Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training.
DISCUSSION


This study will provide insight into the ability of a multi-modal cognitive-motor intervention to reduce dual-task cost and to enhance information processing speed in those with MS. This is one of the first studies that is powered to understand whether targeted dual-task training can improve MS symptoms and increase functional ambulation. We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.",2020,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"['people with multiple sclerosis', '144 people with MS', 'individuals with Multiple Sclerosis (MS']","['conventional treadmill training', 'combined cognitive-motor virtual reality training', 'modal virtual reality treadmill intervention', 'treadmill training alone group or treadmill training with virtual reality group', 'dual-task training', 'training while walking on a treadmill, with the virtual reality group receiving feedback from the virtual system']","['dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and three months following training', 'mobility and cognitive function', 'functional ambulation', 'dual-task gait speed and information processing speed', 'MS symptoms and increase functional ambulation', 'MS symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0376392', 'cui_str': 'Virtual Systems'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",144.0,0.0521126,We anticipate that those in the virtual reality group will have a significantly greater increase in dual-task gait speed and information processing speed than those achieved via treadmill training alone.,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mirelman', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shema-Shiratzky', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Galperin', 'Affiliation': 'Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Regev', 'Affiliation': 'Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schmitz-Hübsch', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karni', 'Affiliation': 'Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Neuroimmunology and Multiple Sclerosis Unit of the Neurology Division, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'NeuroCure, Charité - Universitaetsmedizin Berlin, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité - Universitaetsmedizin Berlin, Berlin, Germany; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Devos', 'Affiliation': 'Laboratory for Advanced Rehabilitation Research in Simulation, Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Sosnoff', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL, USA; Illinois Multiple Sclerosis Research Collaborative, Interdisciplinary Health Science Institute, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hausdorff', 'Affiliation': ""Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel; Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Rush Alzheimer's Disease Center and Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA. Electronic address: jhausdor@tlvmc.gov.il.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106122']
1854,32861377,Remote ischemic preconditioning for prevention of contrast-induced nephropathy - A randomized control trial.,"BACKGROUND


There is a lack of sufficient data regarding the protective effects of remote ischemic preconditioning (RIPC) in patients at risk of developing contrast-induced nephropathy (CIN). Thus, this study was conducted to determine whether RIPC as an adjunct to standard therapy prevents CIN in high-risk patients undergoing coronary intervention.
METHODS


In a single-center, double-blinded, randomized controlled trial, 162 patients who were at risk of CIN received standard hydration combined with RIPC or hydration with sham preconditioning. RIPC was accomplished by four cycles of 5 min ischemia and 5 min reperfusion of the forearm. The primary endpoint was a rise in serum creatinine (>0.5 mg/dL or >25%) from baseline to serum creatinine 48-72 h after contrast administration.
RESULTS


Of the 162 patients, 81 were randomly allocated to receive sham preconditioning and 81 to receive RIPC. Significantly reduced serum creatinine levels were observed in patients with a Mehran moderate risk allocated to sham group compared to the RIPC group (0.070 ± 0.16 mg/dL vs. 0.107 ± 0.13 mg/dL, p = 0.001). With regards to the primary endpoint, a significantly higher change in serum creatinine from baseline to 48-72 h was observed in the sham group compared to the RIPC group (0.023 ± 0.2 μmol/L vs -0.064 ± 0.1 μmol/L, p < 0.001).
CONCLUSION


RIPC as an alternative to standard therapy, improved serum creatinine levels after contrast administration in patients at risk of CIN. However, present data indicate that RIPC might have beneficial effects in patients with a moderate or high risk of CIN.",2020,Significantly reduced serum creatinine levels were observed in patients with a Mehran moderate risk allocated to sham group compared to the RIPC group (0.070 ± 0.16 ,"['patients with a moderate or high risk of CIN', 'patients at risk of developing contrast-induced nephropathy (CIN', 'high-risk patients undergoing coronary intervention', '162 patients', '162 patients who were at risk of CIN received']","['RIPC', 'sham preconditioning and 81 to receive RIPC', 'Remote ischemic preconditioning', 'standard hydration combined with RIPC or hydration with sham preconditioning', 'remote ischemic preconditioning (RIPC']","['rise in serum creatinine', 'serum creatinine levels', 'serum creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}]",162.0,0.467333,Significantly reduced serum creatinine levels were observed in patients with a Mehran moderate risk allocated to sham group compared to the RIPC group (0.070 ± 0.16 ,"[{'ForeName': 'Akshay Ashok', 'Initials': 'AA', 'LastName': 'Bafna', 'Affiliation': 'Department of Cardiology, Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital, Kolhapur, India. Electronic address: drbafnaakshay@gmail.com.'}, {'ForeName': 'Hetan C', 'Initials': 'HC', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiology, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College, Mumbai, India.'}]",Indian heart journal,['10.1016/j.ihj.2020.04.010']
1855,32861846,"The emergence of age-related deterioration in dynamic, but not quiet standing balance abilities among healthy middle-aged adults.","The purpose of the present study was to quantify differences in lower extremity reach performance, static posturography and gait outcomes between young (20-39 years), middle-aged (40-59 years) and older (60-79 years) adults using identical tests and parameters. This was a cross-sectional study with three parallel groups (young [20-39 years] vs. intermediate [40-59 years] vs. older [60-79 years] adults). In a randomised order each participant completed: (i) static posturography, (ii) lower extremity reach performance, and (iii) gait assessment. Changes in balance between age groups were analysed using analysis of variance (ANOVA). Additionally, correlational analysis was used to identify relationships between age and outcome measures. Centre of pressure (COP) movement was greater in older compared to intermediate-aged (d = 0.50-2.40) and young (d = 0.54-2.61) adults (p < 0.001). Reduced lower extremity reach distance was found in older compared to intermediate-aged (d = 1.28-3.60) and young (d = 2.09-3.87) adults (p < 0.001), while young adults demonstrated greater reach distances than intermediate (d = 0.64-1.74) aged adults (p < 0.001). Correlational analysis revealed moderate to strong positive correlations between age across the adult life span (20-79 years) for all COP metrics and lower extremity reach outcomes. When correlational analyses were performed only in the young and middle-aged groups (20-59 years), coefficients were weak and not significant for the COP, but remained moderate for lower extremity reach performance. Lower extremity reach performance reveals earlier age-related declines in postural stability that are not evident during quiet standing tasks of varying difficulty. These findings should contribute to the early identification of potential balance deficits in those where balance problems do not yet exist, which will assist clinical decision making with respect to timely implementation of fall prevention strategies.",2020,Centre of pressure (COP) movement was greater in older compared to intermediate-aged (d = 0.50-2.40) and young (d = 0.54-2.61) adults (p < 0.001).,"['young (20-39\u202fyears), middle-aged (40-59\u202fyears) and older (60-79\u202fyears) adults using identical tests and parameters', 'healthy middle-aged adults', 'three parallel groups (young [20-39\u202fyears] vs. intermediate [40-59\u202fyears] vs. older [60-79\u202fyears] adults']","['static posturography, (ii) lower extremity reach performance, and (iii) gait assessment']","['lower extremity reach performance, static posturography and gait outcomes', 'Centre of pressure (COP) movement', 'extremity reach distance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0228615,Centre of pressure (COP) movement was greater in older compared to intermediate-aged (d = 0.50-2.40) and young (d = 0.54-2.61) adults (p < 0.001).,"[{'ForeName': 'Mathew William', 'Initials': 'MW', 'LastName': 'Hill', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, School of Life Sciences, Coventry University, Warwickshire, United Kingdom. Electronic address: matt.hill@coventry.ac.uk.'}, {'ForeName': 'Michael Joseph', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, School of Life Sciences, Coventry University, Warwickshire, United Kingdom.'}, {'ForeName': 'Michael James', 'Initials': 'MJ', 'LastName': 'Price', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, School of Life Sciences, Coventry University, Warwickshire, United Kingdom.'}]",Experimental gerontology,['10.1016/j.exger.2020.111076']
1856,32861897,Testing an app-based intervention to improve insomnia in patients with epilepsy: A randomized controlled trial.,"PURPOSE


Insomnia has adverse effects on people with epilepsy. We aimed to test a novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention on insomnia symptoms and social psychological factors in people with epilepsy and to examine the possible mechanisms among the factors.
METHODS


Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia. A two-arm randomized controlled trial design was used, consisting of a treatment group (CBT-I; n = 160) and control group (patient education; n = 160). Primary outcomes were self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy. Secondary outcomes were attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL). All outcomes were measured at baseline, and at one, three, and six months postintervention, except objective sleep, which was assessed at baseline, and one and six months postintervention. Data were analyzed using linear mixed models.
RESULTS


Current findings showed that sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency were significantly improved in the CBT-I group compared with the patient education group at all measurement points. Also, the CBT-I group had significantly improved anxiety, depression, and QoL compared with the patient education group. Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
CONCLUSION


Results support the use of the CBT-I app to improve sleep outcomes among people with epilepsy.",2020,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
","['patients with epilepsy', 'people with epilepsy', 'Participants were recruited from neurology clinics in Iran and comprised individuals diagnosed with epilepsy and having moderate to severe insomnia']","['Testing an app-based intervention', 'novel cognitive behavioral therapy for insomnia (CBT-I) app-based intervention']","['insomnia symptoms and social psychological factors', 'sleep quality, insomnia severity, sleep hygiene behavior, and sleep onset latency', 'attitude, intention, coping planning, self-monitoring, and behavioral automaticity', 'anxiety, depression, and QoL', 'self-reported sleep quality, insomnia severity, and sleep hygiene behavior and objective sleep characteristics measured by actigraphy', 'attitude, perceived behavioral control, intention, action planning, coping planning, behavioral automaticity, self-monitoring, anxiety, depression, and quality of life (QoL', 'sleep outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0878237,"Mediation analyses showed that attitude, intention, coping planning, self-monitoring, and behavioral automaticity significantly mediated the effect of the intervention on sleep outcomes.
","[{'ForeName': 'Daniel Kwasi', 'Initials': 'DK', 'LastName': 'Ahorsu', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Chung-Ying', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health & Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Imani', 'Affiliation': 'Pediatric Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Nygårdh', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Broström', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Department of Clinical Neurophysiology, University Hospital, Linköping, Sweden.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Hamilton', 'Affiliation': 'School of Applied Psychology, Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Pakpour', 'Affiliation': 'Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden; Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran. Electronic address: Pakpour_Amir@yahoo.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107371']
1857,32862676,Intravenous tranexamic acid reduces blood loss and transfusion requirements after periacetabular osteotomy.,"AIMS


Tranexamic acid (TXA) has been shown to reduce blood loss and transfusion requirements in patients undergoing orthopaedic surgery. There remains a lack of prospective evidence for the use of TXA in patients undergoing periacetabular osteotomy (PAO). The purpose of this study was to determine if intravenous (IV) TXA is effective in reducing calculated blood loss and transfusions after PAO.
METHODS


This was a single-centre prospective double-blind placebo-controlled randomized trial of 81 patients aged 12 to 45 years undergoing elective PAO by a single surgeon. The intervention group (n = 40) received two doses of IV TXA of a maximum 1 g in each dose; the control group (n = 41) received two doses of 50 ml 0.9% saline IV. The primary outcome was perioperative calculated blood loss. Secondary outcomes included allogenic transfusions and six-week postoperative complications.
RESULTS


There were no differences in demographics or intraoperative variables between study groups. The TXA group demonstrated lower mean calculated blood loss (1,265 ml, (SD 321) vs 1,515 ml, (SD 394); p = 0.002) and lower frequency of allogenic transfusion (10%/n = 4 vs 37%/n = 15; p = 0.008). Regression analyses associated TXA use with significant reductions in calculated blood loss (p < 0.001) and transfusion (p = 0.007) after adjusting for age, sex, body mass index, preoperative haemoglobin, cell-saver volume, intraoperative mean arterial blood pressure, and operating time. No patients suffered venous thromboembolic complications.
CONCLUSION


In this trial, IV TXA decreased postoperative calculated blood loss by 293 ml and reduced the frequency of allogenic transfusions by 73% (37% vs 10%) following PAO. TXA may be safe and effective for reducing blood loss in patients undergoing PAO. Cite this article:  Bone Joint J  2020;102-B(9):1151-1157.",2020,"Regression analyses associated TXA use with significant reductions in calculated blood loss (p < 0.001) and transfusion (p = 0.007) after adjusting for age, sex, body mass index, preoperative haemoglobin, cell-saver volume, intraoperative mean arterial blood pressure, and operating time.","['patients undergoing orthopaedic surgery', 'periacetabular osteotomy', 'patients undergoing periacetabular osteotomy (PAO', '81 patients aged 12 to 45 years undergoing elective PAO by a single surgeon', 'patients undergoing PAO']","['IV TXA', 'Tranexamic acid (TXA', 'two doses of 50 ml 0.9% saline IV', 'placebo', 'intravenous (IV) TXA', 'TXA', 'Intravenous tranexamic acid']","['frequency of allogenic transfusions', 'calculated blood loss', 'mean calculated blood loss', 'frequency of allogenic transfusion', 'blood loss and transfusion requirements', 'body mass index, preoperative haemoglobin, cell-saver volume, intraoperative mean arterial blood pressure, and operating time', 'allogenic transfusions and six-week postoperative complications', 'venous thromboembolic complications', 'postoperative calculated blood loss', 'perioperative calculated blood loss', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",81.0,0.356168,"Regression analyses associated TXA use with significant reductions in calculated blood loss (p < 0.001) and transfusion (p = 0.007) after adjusting for age, sex, body mass index, preoperative haemoglobin, cell-saver volume, intraoperative mean arterial blood pressure, and operating time.","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Levack', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'McLawhorn', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'DelPizzo', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Sink', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}]",The bone & joint journal,['10.1302/0301-620X.102B9.BJJ-2019-1777.R1']
1858,32862688,A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design.,"AIMS


The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs).
METHODS


A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively.
RESULTS


The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001).
CONCLUSION


In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article:  Bone Joint J  2020;102-B(9):1158-1166.",2020,"In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma.","['74 patients', 'cemented cruciate-retaining knee prosthesis with the PFC-sigma design']",['cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component'],"['clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs', 'mean backward tilting', 'backwards tilting and radiolucent lines', 'overall migration (mean maximum total point motion (MPTM', 'Overall migration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0022748', 'cui_str': 'Knee joint prosthesis'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0441550', 'cui_str': 'Press-fit component fixation'}, {'cui': 'C1719918', 'cui_str': 'Sigma'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0443285', 'cui_str': 'Radiolucent'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]",,0.113022,"In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma.","[{'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Kaptein', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'den Hollander', 'Affiliation': 'Department of Orthopaedic Surgery, Haaglanden Medical Center, The Hague, Netherlands.'}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Thomassen', 'Affiliation': 'Faculty Health, Nutrition and Sports, The Hague University of Applied Sciences, The Hague, Netherlands.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Fiocco', 'Affiliation': 'Mathematical Institute, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Rob G H H', 'Initials': 'RGHH', 'LastName': 'Nelissen', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands.'}]",The bone & joint journal,['10.1302/0301-620X.102B9.BJJ-2020-0096.R1']
1859,32864542,Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring.,"The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A 1c  (HbA 1c ) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA 1c  decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks ( P  < .001) and mean time in range (70-180 mg/dL, 3.9-10.0 mmol/L) increased from an estimated 48% ± 18% to 59% ± 20% ( P  < .001), an increase of approximately 2.7 hours/day. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin.",2020,"Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management.","['Adults with type 1 diabetes (N\u2005=\u200527) or type 2 diabetes using insulin (N\u2005=\u20057) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail', 'All 34 participants (mean age, 46\u2005±\u200518 years; 53% female, 85% white', 'people with diabetes using insulin']","['continuous glucose monitoring (CGM', 'CGM']","['Mean HbA 1c', 'Hemoglobin A 1c  (HbA 1c ', 'mean time in range', 'quality-of-life indicators', 'glycemic control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0521098,"Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management.","[{'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Gal', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Nathan J', 'Initials': 'NJ', 'LastName': 'Cohen', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center Park Nicollet, St Louis Park, Minnesota.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Terra', 'Initials': 'T', 'LastName': 'Cushman', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Haban', 'Affiliation': 'UW-Madison Dept. of Family Medicine and Community Health: Wisconsin Research and Education Network (WREN), Madison, Wisconsin.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'International Diabetes Center Park Nicollet, St Louis Park, Minnesota.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'McArthur', 'Affiliation': 'Cecelia Health, New York, New York.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Olson', 'Affiliation': 'Lagoon Health, Minneapolis, Minnesota.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Oser', 'Affiliation': 'University of Colorado School of Medicine, Department of Family Medicine and State Network of Colorado Ambulatory Practices & Partners (SNOCAP), Aurora, Colorado.'}, {'ForeName': 'Tamara K', 'Initials': 'TK', 'LastName': 'Oser', 'Affiliation': 'University of Colorado School of Medicine, Department of Family Medicine and State Network of Colorado Ambulatory Practices & Partners (SNOCAP), Aurora, Colorado.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bugielski', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Strayer', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa076']
1860,32868782,Asthma exacerbations and worsenings in patients aged 1-75 years with add-on tiotropium treatment.,"This review explores the effect of tiotropium Respimat® add-on therapy on asthma exacerbations and worsenings, adverse events (AEs) related to exacerbations and symptoms and any effects on seasonality across the 10 UniTinA-asthma® clinical trials comprising over 6000 patients. When added on to inhaled corticosteroids ± additional therapies, tiotropium significantly reduced the risk of exacerbations and worsenings in adults with symptomatic severe asthma and provided a non-significant improvement in worsenings in adults with symptomatic moderate and mild asthma, which was significant for patients with moderate asthma receiving tiotropium 2.5 µg once daily vs. placebo. Trials in paediatric patients were not powered to assess exacerbations or worsenings, but when AEs related to asthma exacerbations and symptoms were grouped into a composite endpoint and pooled, tiotropium improved outcomes vs. placebo (rate ratio 0.76; 95% confidence interval 0.63, 0.93). The reduction in exacerbations with tiotropium is apparent across all patients during the observed seasonal peaks of these events.",2020,"When added on to inhaled corticosteroids ± additional therapies, tiotropium significantly reduced the risk of exacerbations and worsenings in adults with symptomatic severe asthma and provided a non-significant improvement in worsenings in adults with symptomatic moderate and mild asthma, which was significant for patients with moderate asthma receiving tiotropium 2.5 µg once daily vs. placebo.","['patients aged 1-75 years with add-on tiotropium treatment', 'paediatric patients', 'adults with symptomatic severe asthma', '6000 patients']","['tiotropium Respimat®', 'placebo', 'tiotropium']",['risk of exacerbations and worsenings'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C3842326', 'cui_str': '6000'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}]",6000.0,0.666766,"When added on to inhaled corticosteroids ± additional therapies, tiotropium significantly reduced the risk of exacerbations and worsenings in adults with symptomatic severe asthma and provided a non-significant improvement in worsenings in adults with symptomatic moderate and mild asthma, which was significant for patients with moderate asthma receiving tiotropium 2.5 µg once daily vs. placebo.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark FitzGerald', 'Affiliation': 'Centre for Heart and Lung Health, Vancouver, BC, Canada. Mark.Fitzgerald@vch.ca.'}, {'ForeName': 'Eckard', 'Initials': 'E', 'LastName': 'Hamelmann', 'Affiliation': 'Klinik für Kinder- und Jugendmedizin, Evangelisches Klinikum Bethel, Bielefeld, Germany.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'Department of Pulmonology and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Hospital Mainz, Mainz, Germany.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00193-w']
1861,32869564,Acute Cystitis Symptom Score questionnaire for measuring patient-reported outcomes in women with acute uncomplicated cystitis: Clinical validation as part of a phase III trial comparing antibiotic and nonantibiotic therapy.,"PURPOSE


The Acute Cystitis Symptom Score (ACSS) used in a clinical trial comparing the phytodrug Canephron®N (BNO 1045) with an antibacterial agent (fosfomycin trometamol [FT]) in the treatment of acute uncomplicated cystitis (AC) in women was evaluated as a patient-reported outcome measure in a  post hoc  analysis.
MATERIALS AND METHODS


This double-blind, randomized, multicenter, phase III noninferiority trial was performed in 51 centers in Europe. The ACSS questionnaire was used to assess severity and course of symptoms.
RESULTS


The  post hoc  analysis included 325 patients treated with BNO 1045 and 332 patients treated with FT (total of 657 patients). The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9). Predefined thresholds using the scoring system of the ACSS could be established and validated to define ""clinical cure.""
CONCLUSIONS


Evaluating not only antibacterial but also nonantibacterial agents indicated for the treatment of AC in women, clinical criteria for diagnostics, and measures of patient-reported outcomes are more important as main objectives than microbiological criteria. In this  post hoc  evaluation, we showed that the ACSS questionnaire, validated in several languages, has the potential to be used as a suitable instrument for diagnostics and patient-reported outcomes in well-designed, international, clinical studies investigating different treatment modalities of uncomplicated urinary tract infections.",2020,"The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9).","['325 patients treated with BNO 1045 and 332 patients treated with FT (total of 657 patients', 'women with acute uncomplicated cystitis', 'acute', '51 centers in Europe']",['phytodrug Canephron®N (BNO 1045) with an antibacterial agent (fosfomycin trometamol [FT'],"['Acute Cystitis Symptom Score questionnaire', 'mean sum-scores of the ACSS-typical domain', 'uncomplicated cystitis (AC']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C5198800', 'cui_str': 'BNO 1045'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0054586', 'cui_str': 'canephron N'}, {'cui': 'C5198800', 'cui_str': 'BNO 1045'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0016610', 'cui_str': 'Fosfomycin'}, {'cui': 'C0041175', 'cui_str': 'Tromethamine'}]","[{'cui': 'C0149523', 'cui_str': 'Acute cystitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",1045.0,0.0417035,"The mean sum-scores of the ACSS-typical domain were comparable between groups on day 1 (BNO 1045: 10.2; FT: 10.1), and then decreased on day 4 (BNO 1045: 5.1; FT: 4.5), at end of treatment on day 8 (BNO 1045: 2.1; FT: 2.1), and at late follow-up on day 38 (BNO 1045: 0.8; FT: 0.9).","[{'ForeName': 'Jakhongir F', 'Initials': 'JF', 'LastName': 'Alidjanov', 'Affiliation': 'Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Overesch', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Abramov-Sommariva', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hoeller', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Steindl', 'Affiliation': 'Bionorica SE, Neumarkt, Germany.'}, {'ForeName': 'Florian M', 'Initials': 'FM', 'LastName': 'Wagenlehner', 'Affiliation': 'Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany.'}, {'ForeName': 'Kurt G', 'Initials': 'KG', 'LastName': 'Naber', 'Affiliation': 'Department of Urology, Technical University of Munich, Munich, Germany. kurt@nabers.de.'}]",Investigative and clinical urology,['10.4111/icu.20200060']
1862,32852531,Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab in Untreated Oral Cavity Squamous Cell Carcinoma: A Phase 2 Open-Label Randomized Clinical Trial.,"Importance


Novel approaches are needed to improve outcomes in patients with squamous cell carcinoma of the oral cavity. Neoadjuvant immunotherapy given prior to surgery and combining programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immune checkpoint inhibitors are 2 strategies to enhance antitumor immune responses that could be of benefit.
Design, Setting, and Participants


In this randomized phase 2 clinical trial conducted at 1 academic center, 29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019.
Interventions


Treatment was administered with nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab, 1 mg/kg, given week 1 only). Patients had surgery 3 to 7 days following cycle 2.
Main Outcomes and Measures


Safety and volumetric response determined using bidirectional measurements. Secondary end points included pathologic and objective response, progression-free survival (PFS), and overall survival. Multiplex immunofluorescence was used to evaluate primary tumor immune markers.
Results


Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38%]). The most common subsite was oral tongue (n = 16). Baseline clinical staging included patients with T2 (n = 20) or greater (n = 9) T stage and 17 patients (59%) with node-positive disease. Median time from cycle 1 to surgery was 19 days (range, 7-21 days); there were no surgical delays. There were toxic effects at least possibly related to study treatment in 21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients. One patient died of conditions thought unrelated to study treatment (postoperative flap failure, stroke). There was evidence of response in both the N and N+I arms (volumetric response 50%, 53%; pathologic downstaging 53%, 69%; RECIST response 13%, 38%; and pathologic response 54%, 73%, respectively). Four patients had major/complete pathologic response greater than 90% (N, n = 1; N+I, n = 3). With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
Conclusions and Relevance


Treatment with N and N+I was feasible prior to surgical resection. We observed promising rates of response in both arms, supporting further neoadjuvant studies with these agents.
Trial Registration


ClinicalTrials.gov Identifier: NCT02919683.",2020,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","['patients with T2 (n\u2009=\u200920) or greater (n\u2009=\u20099) T stage and 17 patients (59%) with node-positive disease', 'Untreated Oral Cavity Squamous Cell Carcinoma', '29 patients with untreated squamous cell carcinoma of the oral cavity (≥T2, or clinically node positive) were enrolled between 2016 to 2019', 'patients with squamous cell carcinoma of the oral cavity', 'Fourteen patients were randomized to nivolumab (N) and 15 patients to nivolumab/ipilimumab (N+I) (mean [SD] age, 62 [12] years; 18 men [62%] and 11 women [38', '21 patients, including grade 3 to 4 events in 2 (N), and 5 (N+I) patients']","['Neoadjuvant Nivolumab or Nivolumab Plus Ipilimumab', 'Neoadjuvant immunotherapy', 'nivolumab, 3 mg/kg, weeks 1 and 3, or nivolumab and ipilimumab (ipilimumab']","['1-year progression-free survival', 'complete pathologic response', 'overall survival', 'Median time', 'pathologic and objective response, progression-free survival (PFS), and overall survival', 'Measures\n\n\nSafety and volumetric response determined using bidirectional measurements', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",14.0,0.271878,"With 14.2 months median follow-up, 1-year progression-free survival was 85% and overall survival was 89%.
","[{'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Schoenfeld', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Hanna', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Vickie Y', 'Initials': 'VY', 'LastName': 'Jo', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bhupendra', 'Initials': 'B', 'LastName': 'Rawal', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Yu-Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Catalano', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lako', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Ciantra', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Weirather', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Shana', 'Initials': 'S', 'LastName': 'Criscitiello', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Luoma', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Chau', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Lorch', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Kass', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Annino', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goguen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': 'Beth-Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Ross', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Hina J', 'Initials': 'HJ', 'LastName': 'Shah', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Danielle N', 'Initials': 'DN', 'LastName': 'Margalit', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Roy B', 'Initials': 'RB', 'LastName': 'Tishler', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kai W', 'Initials': 'KW', 'LastName': 'Wucherpfennig', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Rodig', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Ravindra', 'Initials': 'R', 'LastName': 'Uppaluri', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Haddad', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA oncology,['10.1001/jamaoncol.2020.2955']
1863,32853585,"Ipilimumab, nivolumab, and brentuximab vedotin combination therapies in patients with relapsed or refractory Hodgkin lymphoma: phase 1 results of an open-label, multicentre, phase 1/2 trial.","BACKGROUND


Recognising that the immune suppressive microenvironment promotes tumour growth in Hodgkin lymphoma, we hypothesised that activating immunity might augment the activity of targeted chemotherapy. We evaluated the safety and activity of combinations of brentuximab vedotin with nivolumab or ipilimumab, or both in patients with relapsed or refractory Hodgkin lymphoma.
METHODS


In this multicentre, open-label, phase 1/2 trial, patients with relapsed or refractory Hodgkin lymphoma aged 18 years or older who had relapsed after at least one line of therapy, with an Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ and marrow function, with no pulmonary dysfunction were eligible for inclusion. Phase 1 primary objectives were to determine the maximum tolerated dose and dose limiting toxicities of brentuximab vedotin combined with ipilimumab (ipilimumab group), nivolumab (nivolumab group), or both (triplet therapy group) using a 3 + 3 dose escalation design with expansion cohorts. During the dose escalation phase, patients were enrolled sequentially into one of six cohorts: in the ipilimumab group fixed brentuximab vedotin 1·8 mg/kg with ipilimumab 1 mg/kg (cohort A) or 3 mg/kg (cohort B); in the nivolumab group fixed nivolumab 3 mg/kg with brentuximab vedotin 1·2 mg/kg (cohort D) or 1·8 mg/kg (cohort E); and in the triplet therapy group fixed nivolumab 3 mg/kg and ipilimumab 1 mg/kg with brentuximab vedotin 1·2 mg/kg (cohort G) or 1·8 mg/kg (cohort H). Additional patients were enrolled in the expansion phase at the same doses of cohorts B, E, and H. All drugs were given intravenously; brentuximab vedotin and nivolumab were given every 3 weeks, ipilimumab was given every 6 weeks in the ipilimumab group and every 12 weeks in the triplet therapy group. All eligible and treated patients were included in the analysis. This phase 1/2 study is registered with ClinicalTrials.gov, NCT01896999. The phase 2, randomised portion of the trial is still enrolling.
FINDINGS


Between March 7, 2014, and Dec 28, 2017, 64 patients were enrolled; two patients in the ipilimumab group and one patient in the nivolumab group were excluded due to ineligibility after enrolment and 61 were evaluable. A total of six dose limiting toxicities were reported in four patients, and the doses used in cohorts B, E, and H were established as maximum tolerated doses and patients were subsequently enrolled onto expansion cohorts (C, F, and I) with these schedules. There were ten (43%) grade 3-4 treatment related adverse events in the ipilimumab group, three (16%) in the nivolumab group, and 11 (50%) in the triplet therapy group including: eight (13%) of 64 patients reporting rash, and colitis, gastritis, pancreatitis and arthritis, and diabetic ketoacidosis each occurring in one (2%) patient. There were two (3%) treatment related deaths, one in the nivolumab group and one in the triplet therapy group. The overall response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, and 82% (60-95) in the triplet therapy group, and the complete response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, and 73% (50-89%) in the triplet therapy group. With a median follow-up of 2·6 years (IQR 1·8-2·9) in the ipilimumab group, 2·4 years (2·2-2·6) in the nivolumab group, and 1·7 years (1·6-1·9) in the triplet therapy group, median progression-free survival is 1·2 years (95% CI 1·7-not reached) in the ipilimumab group, but was not reached in the other two treatment groups. Median overall survival has not been reached in any of the groups.
INTERPRETATION


There are clear differences in activity and toxicity of the three combination regimens. The tolerability and preliminary activity for the two most active regimens, brentuximab vedotin with nivolumab and the triplet therapy, are being compared in a randomised phase 2 trial (NCT01896999).
FUNDING


Eastern Cooperative Oncology Group-American College of Radiology Imaging Network and the National Cancer Institute of the National Institutes of Health.",2020,"The overall response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, and 82% (60-95) in the triplet therapy group, and the complete response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, and 73% (50-89%) in the triplet therapy group.","['patients with relapsed or refractory Hodgkin lymphoma', 'patients with relapsed or refractory Hodgkin lymphoma aged 18 years or older who had relapsed after at least one line of therapy, with an Eastern Cooperative Oncology Group performance status of 2 or lower, and adequate organ and marrow function, with no pulmonary dysfunction were eligible for inclusion', 'Between March 7, 2014, and Dec 28, 2017, 64 patients were enrolled; two patients in the ipilimumab group and one patient in the nivolumab group were excluded due to ineligibility after enrolment and 61 were evaluable']","['ipilimumab (ipilimumab group), nivolumab (nivolumab group), or both (triplet therapy', 'Ipilimumab, nivolumab, and brentuximab vedotin combination therapies', 'triplet therapy group fixed nivolumab 3 mg/kg and ipilimumab 1 mg/kg with brentuximab vedotin 1·2 mg/kg', 'brentuximab vedotin with nivolumab or ipilimumab', 'ipilimumab group fixed brentuximab vedotin 1·8 mg/kg with ipilimumab', 'nivolumab group fixed nivolumab 3 mg/kg with brentuximab vedotin 1·2 mg/kg', 'ipilimumab']","['complete response rate', 'adverse events', 'overall response rate', 'maximum tolerated dose and dose limiting toxicities', 'activity and toxicity', 'median progression-free survival', 'Median overall survival', 'rash, and colitis, gastritis, pancreatitis and arthritis, and diabetic ketoacidosis', 'toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855082', 'cui_str': ""Refractory Hodgkin's lymphoma""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",64.0,0.0744334,"The overall response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, and 82% (60-95) in the triplet therapy group, and the complete response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, and 73% (50-89%) in the triplet therapy group.","[{'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Diefenbach', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA. Electronic address: catherine.diefenbach@nyulangone.org.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Biostatistics Center, Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Ambinder', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jonathon B', 'Initials': 'JB', 'LastName': 'Cohen', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Robertson', 'Affiliation': 'School of Medicine, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'David', 'Affiliation': 'Division of Blood Disorders, Rutgers Cancer Institute of New Jersey, New Jersey, NJ, USA.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Oncology Division, Stanford Cancer Institute, Stanford, CA, USA.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Fenske', 'Affiliation': 'Division of Hematology and Oncology, Froedtert and the Medical College of Wisconsin, Wauwatosa, WI, USA.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'Barta', 'Affiliation': 'Divison of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Palmisiano', 'Affiliation': 'Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Svoboda', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Morgan', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Karmali', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Northwestern University, Evanston, IL, USA.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Sharon', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethseda, MD, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Streicher', 'Affiliation': 'Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethseda, MD, USA.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Kahl', 'Affiliation': 'School of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ansell', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester MN, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30221-0']
1864,32853647,Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone.,"BACKGROUND


Long-term testosterone replacement therapy (TRT) increases muscle mass in elderly men with subnormal testosterone levels. However, the molecular mechanisms underlying this effect of TRT on protein balance in human skeletal muscle in vivo remain to be established.
METHODS


Here, we examined skeletal muscle biopsies obtained before and 24-h after the last dose of treatment with either testosterone gel (n = 12) or placebo (n = 13) for 6 months in aging men with subnormal bioavailable testosterone levels. The placebo-controlled, testosterone-induced changes (β-coefficients) in mRNA levels, protein expression and phosphorylation were examined by quantitative real-time PCR and western blotting.
RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors. However, TRT caused a sustained decrease in protein expression of SMAD2 (β = -36%, p = 0.004) and SMAD3 (β = -32%, p = 0.001), which was accompanied by reduced protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1 (β = -26%, p = 0.004) and Atrogin-1/MAFbx (β = -20%, p = 0.04), but with no changes in FOXO3 signalling. Importantly, TRT did not affect muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres.
CONCLUSIONS


Our results indicate that long-term TRT of elderly men with subnormal testosterone levels increases muscle mass, at least in part, by decreasing protein breakdown through the ubiquitin proteasome pathway mediated by a sustained suppression of SMAD-signalling and muscle-specific E3-ubiquitin ligases.",2020,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","['aging men with subnormal testosterone', 'elderly men with subnormal testosterone levels']","['testosterone replacement therapy (TRT', 'long-term testosterone therapy', 'placebo', 'testosterone gel', 'TRT']","['muscle fibre type distribution between slow-oxidative (type 1), fast-oxidative (type 2a) and fast-glycolytic (type 2×) muscle fibres', 'protein expression of SMAD2', 'Atrogin-1/MAFbx', 'muscle mass', 'skeletal muscle mass and fibre-type distribution', 'protein expression of the muscle-specific E3-ubiquitin ligases, MuRF1', 'mRNA levels, protein expression and phosphorylation', 'mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}]","[{'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1566790', 'cui_str': 'SMAD2 protein, human'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0041538', 'cui_str': 'Ubiquitin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0050668', 'cui_str': 'Activin hormone'}, {'cui': 'C0076925', 'cui_str': 'USF Transcription Factors'}]",,0.0809258,"RESULTS


Long-term TRT increased muscle mass by β = 1.6 kg (p = 0.01) but had no significant effect on mRNA levels of genes involved in myostatin/activin/SMAD or IGF1/FOXO3 signalling, muscle-specific E3-ubiquitin ligases, upstream transcription factors (MEF2C, PPARGC1A-4) or myogenic factors.","[{'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Kruse', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Stine J', 'Initials': 'SJ', 'LastName': 'Petersson', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark; Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, University of Copenhagen, DK-2100 Copenhagen, Denmark.'}, {'ForeName': 'Rugivan', 'Initials': 'R', 'LastName': 'Sabaratnam', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, SDU Muscle Research Cluster (SMRC), University of Southern Denmark, DK-5230 Odense, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Andersen', 'Affiliation': 'Department of Endocrinology, Odense University Hospital, DK-5000 Odense C, Denmark.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Højlund', 'Affiliation': 'Steno Diabetes Center Odense, Odense University Hospital, DK-5000 Odense C, Denmark; Department of Clinical Research & Department of Molecular Medicine, University of Southern Denmark, DK-5000 Odense C, Denmark. Electronic address: kurt.hoejlund@rsyd.dk.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154347']
1865,32853672,Safety and effectiveness of azithromycin in patients with COVID-19: An open-label randomised trial.,"As no specific pharmacological treatment has been validated for use in coronavirus disease 2019 (COVID-19), we aimed to assess the effectiveness of azithromycin (AZM) in these patients at a referral centre in Iran. An open-label, randomised controlled trial was conducted on patients with laboratory-confirmed COVID-19. A total of 55 patients in the control group receiving hydroxychloroquine (HCQ) and lopinavir/ritonavir (LPV/r) were compared with 56 patients in the case group who in addition to the same regimen also received AZM. Patients with prior cardiac disease were excluded from the study. Furthermore, patients from the case group were assessed for cardiac arrythmia risk based on the American College of Cardiology (ACC) risk assessment for use of AZM and HCQ. The main outcome measures were vital signs, SpO 2  levels, duration of hospitalisation, need for and length of intensive care unit admission, mortality rate and results of 30-day follow-up after discharge. Initially, there was no significant difference between the general conditions and vital signs of the two groups. The SpO 2  levels at discharge were significantly higher, the respiratory rate was lower and the duration of admission was shorter in the case group. There was no significant difference in the mortality rate between the two groups. Patients who received AZM in addition to HCQ and LPV/r had a better general condition. HCQ+AZM combination may be beneficial for individuals who are known to have a very low underlying risk for cardiac arrhythmia based on the ACC criteria.",2020,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","['patients at a referral center in Iran', 'Patients with COVID-19', 'Patients with prior cardiac disease', 'patients with laboratory confirmed COVID-19']","['hydroxychloroquine', 'azithromycin and hydroxychloroquine', 'azithromycin', 'hydroxychloroquine-azithromycin', 'hydroxychloroquine and lopinavir / ritonavir', 'Azithromycin']","['respiratory rate', 'duration of admission', 'mortality rate', 'SpO2 levels at discharge', 'cardiac arrythmia risk', 'vital signs, SpO2 levels, duration of hospitalization, need for and length of intensive care unit (ICU) admission, mortality rates, and results of 30-day follow-up after discharge', 'general conditions and vital signs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0611014,"The SpO2 levels at discharge were significantly higher, the respiratory rate was lower, and the duration of admission was shorter in the case group.","[{'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Sekhavati', 'Affiliation': 'Department of Cardiology, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Jafari', 'Affiliation': 'Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran; Iran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: fatemejafari72@gmail.com.'}, {'ForeName': 'SeyedAhmad', 'Initials': 'S', 'LastName': 'SeyedAlinaghi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeidreza', 'Initials': 'S', 'LastName': 'Jamalimoghadamsiahkali', 'Affiliation': 'Department of Infectious Diseases, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Sadr', 'Affiliation': 'Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabarestani', 'Affiliation': 'Medical Students Research Committee, Mazandaran University of Medical Sciences, School of Medicine, Sari, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Pirhayati', 'Affiliation': 'Iran University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Zendehdel', 'Affiliation': 'Geriatric Department, Ziayian Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Manafi', 'Affiliation': 'Iran University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadinejad', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran 14197-33141, Iran.'}, {'ForeName': 'Hamid Emadi', 'Initials': 'HE', 'LastName': 'Kouchak', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sirous', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh Shahmari', 'Initials': 'FS', 'LastName': 'Golestan', 'Affiliation': 'Department of Infectious Diseases, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Liver Transplantation Research Center, Department of Infectious Diseases, Imam Khomeini Hospital Complex, Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran 14197-33141, Iran. Electronic address: ghiasvand_62@yahoo.com.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106143']
1866,32854537,Effect of consuming a late-night high-protein/moderate-carbohydrate vs. low-protein/high-carbohydrate meal by night workers on their food perceptions later during the day: a randomized crossover study.,"It is typical of night workers to consume a large dinner meal before their work shift, even though this practice may increase the risk for metabolic disorders. Night workers usually eat at night to socialize with colleagues as well as to stay alert and to avoid upset stomach during the night shift. However, little is known if and how the composition of the nighttime meal by night shift workers influences their food perceptions and eating behavior later during the day. The aim of this study was to analyze the effect of a high-protein/moderate-carbohydrate (HP/MCHO) meal vs. low-protein/high-carbohydrate (LP/HCHO) meal eaten at night by night-shift workers on their food consumption and perceptions later during the day. Fourteen male night shift workers were followed-up for 7 days for their eating and sleep habits. Then, participants underwent two isocaloric dietary events - one event a HP/MCHO meal containing 45% carbohydrate, 35% protein, and 20% fat and the other event a LP/HCHO meal containing 65% carbohydrate, 15% protein, and 20% fat, with a 6-day washout period between them - at 01:00 h during their night shift. Thereafter throughout the day, participants filled a food register of all the food consumed and perceptions, including hunger before meals, enjoyment of meals, and satiety. Generalized estimating equation analyses were used to examine the effect of both conditions on food consumption and food perceptions. Appetite for salty food snacks was greater after the HP/MCHO condition than after the LP/HCHO condition ( p  = .041). During the day following consumption of the nighttime HP/MCHO vs. LP/HCHO meal, there was higher percentage of carbohydrate consumption during lunch and a lower percentage of fat consumption during dinner (48.14% vs. 36.98% and 27.34% vs. 40.39%, respectively). These findings suggest the composition in terms of carbohydrates, protein, and fats of the meal consumed for the night shift by night workers may affect later during the day both food consumption and perceptions.",2020,Appetite for salty food snacks was greater after the HP/MCHO condition than after the LP/HCHO condition ( p  = .041).,"['Fourteen male night shift workers', 'night workers on their food perceptions later during the day']","['high-protein/moderate-carbohydrate (HP/MCHO) meal vs. low-protein/high-carbohydrate (LP/HCHO) meal eaten', 'consuming a late-night high-protein/moderate-carbohydrate vs. low-protein/high-carbohydrate meal', 'nighttime HP/MCHO vs. LP/HCHO meal', 'isocaloric dietary events - one event a HP/MCHO meal containing 45% carbohydrate, 35% protein, and 20% fat and the other event a LP/HCHO meal containing 65% carbohydrate, 15% protein, and 20% fat']","['Appetite for salty food snacks', 'fat consumption', 'carbohydrate consumption']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0555008', 'cui_str': 'Night shift worker'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0065058', 'cui_str': 'Lipoprotein (a)'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0453862', 'cui_str': 'Salty food'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",14.0,0.014578,Appetite for salty food snacks was greater after the HP/MCHO condition than after the LP/HCHO condition ( p  = .041).,"[{'ForeName': 'Catarina Mendes', 'Initials': 'CM', 'LastName': 'Silva', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Nayara Bernardes Da', 'Initials': 'NBD', 'LastName': 'Cunha', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Maria Carliana', 'Initials': 'MC', 'LastName': 'Mota', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Luisa Pereira', 'Initials': 'LP', 'LastName': 'Marot', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Kely Raspante Cerqueira', 'Initials': 'KRC', 'LastName': 'Teixeira', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Thulio Marquez', 'Initials': 'TM', 'LastName': 'Cunha', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}, {'ForeName': 'Cibele Aparecida', 'Initials': 'CA', 'LastName': 'Crispim', 'Affiliation': 'Graduate Program of Health Sciences, Faculty of Medicine, Federal University of Uberlândia , Minas Gerais, Brazil.'}]",Chronobiology international,['10.1080/07420528.2020.1807561']
1867,32857955,"Immediate impact of stay-at-home orders to control COVID-19 transmission on socioeconomic conditions, food insecurity, mental health, and intimate partner violence in Bangladeshi women and their families: an interrupted time series.","BACKGROUND


Stay-at-home orders (lockdowns) have been deployed globally to control COVID-19 transmission, and might impair economic conditions and mental health, and exacerbate risk of food insecurity and intimate partner violence. The effect of lockdowns in low-income and middle-income countries must be understood to ensure safe deployment of these interventions in less affluent settings. We aimed to determine the immediate impact of COVID-19 lockdown orders on women and their families in rural Bangladesh.
METHODS


An interrupted time series was used to compare data collected from families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown. We also assessed women's experiences of intimate partner violence during the pandemic.
RESULTS


Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent. 2414 (99·9%, 95% CI 99·6-99·9) of 2417 mothers were aware of, and adhering to, the stay-at-home advice. 2321 (96·0%, 95·2-96·7) of 2417 mothers reported a reduction in paid work for the family. Median monthly family income fell from US$212 at baseline to $59 during lockdown, and the proportion of families earning less than $1·90 per day rose from five (0·2%, 0·0-0·5) of 2422 to 992 (47·3%, 45·2-49·5) of 2096 (p<0·0001 comparing baseline with lockdown period). Before the pandemic, 136 (5·6%, 4·7-6·6) of 2420 and 65 (2·7%, 2·1-3·4) of 2420 families experienced moderate and severe food insecurity, respectively. This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001). Mothers' depression and anxiety symptoms increased during the lockdown. Among women experiencing emotional or moderate physical violence, over half reported it had increased since the lockdown.
INTERPRETATION


COVID-19 lockdowns present significant economic, psychosocial, and physical risks to the wellbeing of women and their families across economic strata in rural Bangladesh. Beyond supporting only the most socioeconomically deprived, support is needed for all affected families.
FUNDING


National Health and Medical Research Council, Australia.",2020,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","['Bangladeshi women and their families', 'Between May 19 and June 18, 2020, we randomly selected and invited the mothers of 3016 children to participate in the study, 2424 of whom provided consent', ""women's experiences of intimate partner violence during the pandemic"", '2414', '2321', '2417 mothers', 'families in Rupganj upazila, rural Bangladesh (randomly selected from participants in a randomised controlled trial), on income, food security, and mental health a median of 1 year and 2 years before the COVID-19 pandemic to data collected during the lockdown', 'women and their families in rural Bangladesh', 'women experiencing emotional or moderate physical violence']",['lockdowns'],"['number of families experiencing any level of food insecurity', ""Mothers' depression and anxiety symptoms"", 'socioeconomic conditions, food insecurity, mental health, and intimate partner violence']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3494174', 'cui_str': 'Food insecurity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",3016.0,0.0664138,"This increased to 881 (36·5%, 34·5-38·4) of 2417 and 371 (15·3%, 13·9-16·8) of 2417 during the lockdown; the number of families experiencing any level of food insecurity increased by 51·7% (48·1-55·4; p<0·0001).","[{'ForeName': 'Jena Derakhshani', 'Initials': 'JD', 'LastName': 'Hamadani', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Imrul', 'Initials': 'MI', 'LastName': 'Hasan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baldi', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sheikh Jamal', 'Initials': 'SJ', 'LastName': 'Hossain', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Shamima', 'Initials': 'S', 'LastName': 'Shiraji', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Saiful Alam', 'Initials': 'MSA', 'LastName': 'Bhuiyan', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Syeda Fardina', 'Initials': 'SF', 'LastName': 'Mehrin', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Fisher', 'Affiliation': 'Department of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Tofail', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'S M Mulk Uddin', 'Initials': 'SMMU', 'LastName': 'Tipu', 'Affiliation': 'International Center for Diarrhoeal Diseases Research, Dhaka, Bangladesh.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Institute of Child Health, University College London, London, UK.'}, {'ForeName': 'Beverley-Ann', 'Initials': 'BA', 'LastName': 'Biggs', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Braat', 'Affiliation': 'Department of Medicine, Peter Doherty Institute, The University of Melbourne, Parkville, VIC, Australia; School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sant-Rayn', 'Initials': 'SR', 'LastName': 'Pasricha', 'Affiliation': 'Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia; Department of Medical Biology, The University of Melbourne, Parkville, VIC, Australia; Diagnostic Haematology, Royal Melbourne Hospital, Parkville, VIC, Australia; Clinical Haematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Parkville, VIC Australia. Electronic address: pasricha.s@wehi.edu.au.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30366-1']
1868,32858333,Experimental sleep restriction increases somatic complaints in healthy adolescents.,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation. In this study, healthy adolescents (n = 30; 14-18yrs) completed a three-week, within-subject cross-over experiment. Following a sleep stabilization week, adolescents were randomized (in counterbalanced order) to five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout."" Somatic complaints were assessed via the Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT) concluding each condition. Adherence to experimental condition was confirmed via actigraphy. Adolescents slept two fewer hours and reported significantly greater frequency and severity of somatic complaints during the Insufficient Sleep (vs. Sufficient Sleep) condition. Restricting sleep opportunity to a level common in adolescence causally increased somatic complaints in otherwise healthy adolescents. Findings support clinical and preventative efforts to address pervasively inadequate sleep in adolescence.",2020,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","['otherwise healthy adolescents', 'healthy adolescents', 'healthy adolescents (n\xa0=\xa030; 14-18yrs']","['Experimental sleep restriction', 'five nights of 6.5hrs in bed (Insufficient Sleep) or 9.5hrs in bed (Sufficient Sleep), each preceded by a two-night ""washout']","[""Children's Somatic Symptoms Inventory (CSSI-24) and the Pain and Symptom Assessment Tool (PSAT"", 'Somatic complaints', 'frequency and severity of somatic complaints']","[{'cui': 'C0686747', 'cui_str': 'Well adolescent'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0189992,"Short duration sleep and somatic complaints (bodily complaints like aches/pains or GI distress) are common in adolescence and may be linked, yet no published studies have tested causation.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Krietsch', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA. Electronic address: kendrakrietsch@gmail.com.""}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'King', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Center for Understanding Pediatric Pain (CUPP), Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Christopher.king@cchmc.org.""}, {'ForeName': 'Dean W', 'Initials': 'DW', 'LastName': 'Beebe', 'Affiliation': ""Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH, 45229-3026, USA; Department of Pediatrics, University of Cincinnati College of Medicine, USA. Electronic address: Dean.beebe@cchmc.org.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.020']
1869,32858346,"Effects of treatment of sleep disorders on sleep, psychological and cognitive functioning and biomarkers in individuals with HIV/AIDS and under methadone maintenance therapy.","BACKGROUND


Poor sleep is a major complaint of people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing methadone maintenance therapy (MMT). We tested the impact of three different sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training + trazodone) on sleep, psychological functioning and biomarkers in males with HIV and undergoing MMT.
METHODS


A total of 75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention. Participants were randomly assigned to one of the following conditions: trazodone 50 mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT + TRAZ). At baseline, and six and 12 weeks later, participants completed questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety. In parallel, their cognitive performance (working memory; sustained attention) was assessed. Biomarkers (cortisol, BNDF, CD4 + ) were assessed at baseline and at the end of the study.
RESULTS


Over time, sleep disturbances decreased and daytime functioning and overall sleep quality improved. More specifically, both sleep disturbances and daytime functioning improved in the two SHT conditions from baseline to week 6. Daytime functioning remained stable from week 6 to week 12. Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12. Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing remained unchanged. Sustained attention performance improved over time from baseline to week 6 and remained high through to week 12. Biomarkers remained unchanged.
CONCLUSIONS


In males with HIV and undergoing MMT, treating sleep disturbances over a period of six to 12 weeks had a positive impact on aspects of sleep disturbance, symptoms of depression and anxiety, and cognitive performance. The results indicate that sleep hygiene training, either as stand-alone or in combination with trazodone, can produce positive results.",2020,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","['75 male outpatients (mean age: 39.6 years) participated in a 12 week intervention', 'males with HIV and undergoing', 'males with HIV and undergoing MMT', 'people with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) and undergoing', 'individuals with HIV/AIDS and under methadone maintenance therapy']","['MMT', 'methadone maintenance therapy (MMT', 'sleep-improving interventions (trazodone; sleep hygiene training; sleep hygiene training\xa0+\xa0trazodone', 'trazodone 50\xa0mg/d (TRAZ); sleep hygiene training (SHT); sleep hygiene training and trazodone (SHT\xa0+\xa0TRAZ', 'trazodone']","['sleep, psychological and cognitive functioning and biomarkers', 'sleep, psychological functioning and biomarkers', 'Daytime sleepiness, symptoms of insomnia and sleep-disordered breathing', 'questionnaires covering subjective sleep and daytime sleepiness, and symptoms of depression and anxiety', 'depression and anxiety', 'Sustained attention performance', 'sleep disturbances and daytime functioning', 'Daytime functioning', 'sleep disturbances', 'Biomarkers (cortisol, BNDF, CD4 + ', 'daytime functioning and overall sleep quality', 'sleep disturbance, symptoms of depression and anxiety, and cognitive performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",75.0,0.0231424,"Over time, in all conditions symptoms of depression and anxiety declined from baseline to week 6 and remained lower from week 6 to week 12.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Alikhani', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Ebrahimi', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Farnia', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Radmehr', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Mohamadi', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Omran', 'Initials': 'O', 'LastName': 'Davarinejad', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Dürsteler', 'Affiliation': 'University of Basel, Psychiatric Clinics, Division of Substance Use Disorders Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'Substance Abuse Prevention Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; Sleep Disorders Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran. Electronic address: serge.brand@upk.ch.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.043']
1870,32858371,Effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.,"OBJECTIVE


Patients may be afraid when they receive knowledge that medications are injected into the middle ear through the tympanic membrane using a fine needle during intratympanic treatment. The aim of this study was to evaluate the effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.
STUDY DESIGN


Prospective, Non-randomized, controlled trial.
SETTING


Tertiary academic medical center.
METHODS


A total of 85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus were included in this prospective study. 40 cases received video-assisted information before intratympanic steroid injection in the study group, while 45 cases were verbally informed face-to-face in the control group. Then, patient anxiety was measured using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI).
RESULTS


The mean VAS score was 3.58 ± 3.37 (mean rank = 42.09) in the study group and 3.87 ± 3.56 (mean rank = 43.81) in the control group. The mean STAI-S score was 37.03 ± 10.637 in the study group and 39.11 ± 11.783 in the control group. The mean STAI-T score was 40.18 ± 9.151 in the study group and 38.73 ± 11.438 in the control group. It was found that there were no statistically significant differences in the mean VAS, STAI-S and STAI-T scores between the two groups (p > 0.05).
CONCLUSION


We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.",2020,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"['40 cases received', 'Tertiary academic medical center', '85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus', 'patient anxiety']","['video-assisted information prior to intratympanic steroid injection', 'video-assisted information before intratympanic steroid injection']","['mean VAS, STAI-S and STAI-T scores', 'mean STAI-T score', 'mean STAI-S score', 'mean VAS score', 'Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI', 'patient anxiety']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",85.0,0.0321367,We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.,"[{'ForeName': 'Nurdoğan', 'Initials': 'N', 'LastName': 'Ata', 'Affiliation': 'Department of Otorhinolaryngology, KTO Karatay University Medical Faculty, Medicana Hospital, Konya, Turkey. Electronic address: op.dr.na@gmail.com.'}, {'ForeName': 'Necat', 'Initials': 'N', 'LastName': 'Alataş', 'Affiliation': 'Department of Otolaryngology, Uşak University Medical Faculty, Uşak, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Güllüev', 'Affiliation': 'Department of Otorhinolaryngology, Medical Sciences University Konya Training and Research Hospital, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': ""Department of Otolaryngology, Dr. Ali Kemal Belviranlı Maternity and Children's Hospital, Konya, Turkey.""}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102689']
1871,32858393,Reducing fall risk for home care workers with slip resistant winter footwear.,"Falls on icy surfaces are the leading cause of occupational injuries for workers exposed to outdoor winter conditions. Slip resistant footwear has been shown to reduce the risk of falls for indoor workers but until recently, there was no accepted standard for evaluating the slip resistance of winter footwear on icy surfaces. Our team recently developed a lab-based testing protocol for measuring footwear slip resistance. This protocol, called the Maximum Achievable Angle (MAA) test, measures the steepest ice-covered slope that participants can walk up and down without experiencing a slip in a simulated winter environment. This lab-based protocol has found there is wide variability in the performance of commercially available winter footwear. In particular, we have found that a new generation of footwear that incorporates composite materials in the outsole, performs much better than most other footwear. The objective of this project was to investigate whether the footwear that performed well in our lab-based testing would reduce the risk of slips and/or falls in real-world winter conditions. One hundred and ten home healthcare workers from SE Health were recruited for this study and were asked to report their exposure to icy surfaces along with the numbers of slips and numbers of falls they experienced each week using online surveys over eight weeks in the winter. Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test. The remaining sixty participants (the control group) wore their own footwear for the duration of the study. A total of 563 slips and 36 falls were reported over the eight-week data collection period. The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group. We found the slip rate in the intervention group was between 68.0% and 68.7% lower than the control group. Similarly, the fall rate was between 78.5% and 81.5% lower in the intervention group compared to the control group. These findings demonstrate that footwear that performs well in the MAA test can reduce the risk of both slips and falls in real-world winter conditions.",2020,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"['Fifty participants (the intervention group) were provided winter footwear that were among the best performing in the MAA test', 'One hundred and ten home healthcare workers from SE Health', 'home care workers with slip resistant winter footwear']",[],"['fall rate', 'slip rate']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]",[],"[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}]",563.0,0.0200659,The intervention group consistently reported fewer slips (127 vs 436) and fewer falls (6 vs 30) compared to the control group.,"[{'ForeName': 'Z Shaghayegh', 'Initials': 'ZS', 'LastName': 'Bagheri', 'Affiliation': 'Department of Mechanical Engineering, George Mason University, 4400 University Dr, Fairfax, VA, 22030, USA; Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada. Electronic address: sbagheri@gmu.edu.'}, {'ForeName': 'Jose Diaz', 'Initials': 'JD', 'LastName': 'Beltran', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Holyoke', 'Affiliation': 'Saint Elizabeth Health Care, 90 Allstate Parkway, Suite 300, Markham, Ontario, L3R 5H3, Canada.'}, {'ForeName': 'Tilak', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Kite Research Institute, Toronto Rehabilitation Institute, University Health Network, 550 University Ave, Toronto, M5G2A2, Canada; Institute of Biomedical Engineering, University of Toronto, 164 College St., Toronto, M5S3G9, Canada.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103230']
1872,32858399,Effect of antenatal magnesium sulphate on MRI biomarkers of white matter development at term equivalent age: The magnum study.,"BACKGROUND


Magnesium sulphate given to women immediately prior to very preterm birth protects the perinatal brain, so fewer babies die or develop cerebral palsy. How magnesium sulphate exerts these beneficial effects remains uncertain. The aim of the MagNUM Study was to assess the effect of exposure to antenatal magnesium sulphate on MRI measures of brain white matter microstructure at term equivalent age.
METHODS


Nested cohort study within the randomised Magnesium sulphate at 30 to <34 weeks' Gestational age Neuroprotection Trial (MAGENTA). Mothers at risk of preterm birth at 30 to <34 weeks' gestation were randomised to receive either 4 g of magnesium sulphate heptahydrate [8 mmol magnesium ions], or saline placebo, infused over 30 min when preterm birth was planned or expected within 24 h. Participating babies underwent diffusion tensor MRI at term equivalent age. The main outcomes were fractional anisotropy across the white matter tract skeleton compared using Tract-based Spatial Statistics (TBSS), with adjustment for postmenstrual age at birth and at MRI, and MRI site. Researchers and families were blind to treatment group allocation during data collection and analyses.
FINDINGS


Of the 109 participating babies the demographics of the 60 babies exposed to magnesium sulphate were similar to the 49 babies exposed to placebo. In babies whose mothers were allocated to magnesium sulphate, fractional anisotropy was higher within the corticospinal tracts and corona radiata, the superior and inferior longitudinal fasciculi, and the inferior fronto-occipital fasciculi compared to babies whose mothers were allocated placebo (P < 0.05).
INTERPRETATION


In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function. This may be one mechanism for the neuroprotective effect of magnesium sulphate treatment prior to preterm birth.
FUNDING


Health Research Council of New Zealand.",2020,"In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function.","['109 participating babies', ""Mothers at risk of preterm birth at 30 to <34 weeks' gestation"", ""at 30 to <34 weeks' Gestational age Neuroprotection Trial"", 'babies born preterm', 'white matter development at term equivalent age', 'brain white matter microstructure at term equivalent age']","['magnesium sulphate heptahydrate [8\xa0mmol magnesium ions], or saline placebo', 'magnesium sulphate', 'placebo', 'Magnesium sulphate', 'antenatal magnesium sulphate']","['fractional anisotropy across the white matter tract skeleton compared using Tract-based Spatial Statistics (TBSS), with adjustment for postmenstrual age at birth and at MRI, and MRI site', 'MRI biomarkers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]","[{'cui': 'C0772046', 'cui_str': 'Magnesium sulfate heptahydrate'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C2346927', 'cui_str': 'Magnesium Cation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.260441,"In babies born preterm, antenatal magnesium sulphate exposure promotes development of white matter microstructure in pathways affecting both motor and cognitive function.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Poppe', 'Affiliation': ""Department of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; Centre for the Developing Brain, Department of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'Department of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; School of Optometry and Vision Science, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Boardman', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom; MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Bastin', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Alsweiler', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Deib', 'Affiliation': 'Department of Radiology, West Virginia University Hospital, W.Va, United States.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Building 503, Level 2, 85 Park Road, Auckland 1142, New Zealand.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Liggins Institute, University of Auckland, Building 503, Level 2, 85 Park Road, Auckland 1142, New Zealand. Electronic address: c.crowther@auckland.ac.nz.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",EBioMedicine,['10.1016/j.ebiom.2020.102957']
1873,32860991,Automated MRI assessment confirms cartilage thickness modification in patients with knee osteoarthritis: post-hoc analysis from a phase II sprifermin study.,"BACKGROUND


Sprifermin is under investigation as a potential disease-modifying osteoarthritis drug. Previously, 2-year results from the FORWARD study showed significant dose-dependent modification of cartilage thickness in the total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions, by quantitative magnetic resonance imaging (qMRI) using manual segmentation.
OBJECTIVE


To determine whether qMRI findings from FORWARD could be reproduced by an independent method of automated segmentation using an identical dataset and similar anatomical regions in a post-hoc analysis.
METHOD


Cartilage thickness was assessed at baseline and 6, 12, 18 and 24 months, using automated cartilage segmentation with active appearance models, a supervised machine learning method. Images were blinded for treatment and timepoint. Treatment effect was assessed by observed and adjusted changes using a linear mixed model for repeated measures.
RESULTS


Based on automated segmentation, statistically significant, dose-dependent structural modification of cartilage thickness was observed over 2 years with sprifermin vs placebo for TFTJ (overall treatment effect and dose response, both P < 0.001), MFTC (P = 0.004 and P = 0.044), and LFTC (both P < 0.001) regions. For highest dose, in the central medial tibial (P = 0.008), central lateral tibial (P < 0.001) and central lateral femoral (P < 0.001) regions.
CONCLUSIONS


Cartilage thickness assessed by automated segmentation provided a consistent dose response in structural modification compared with manual segmentation. This is the first time that two independent quantification methods of image analysis have reached the same conclusions in an interventional trial, strengthening the conclusions that sprifermin modifies structural progression in knee osteoarthritis.",2020,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
",['patients with knee osteoarthritis'],"['placebo', 'MRI assessment']","['structural modification of cartilage thickness', 'total femorotibial joint (TFTJ), medial and lateral femorotibial compartments (MFTC, LFTC), and central medial and lateral TFTJ subregions', 'cartilage thickness', 'central lateral tibial (P<0.001) and central lateral femoral', 'MFTC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0581602', 'cui_str': 'Structural modification'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",,0.166877,"For highest dose, in the central medial tibial (P=0.008), central lateral tibial (P<0.001) and central lateral femoral (P<0.001) regions.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: Alan.Brett@stryker.com.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Manchester, UK. Electronic address: mike.bowes@stryker.com.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds & NIHR Leeds Biomedical Research Centre, Leeds, UK. Electronic address: p.conaghan@leeds.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ladel', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: christoph.ladel@merckgroup.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Guehring', 'Affiliation': 'Merck KGaA, Darmstadt, Germany. Electronic address: hans.guehring@merckgroup.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Moreau', 'Affiliation': 'EMD Serono, Billerica, MA, USA. Electronic address: flavie.moreau@emdserono.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Department of Imaging and Functional Musculoskeletal Research, Institute of Anatomy & Cell Biology, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria; Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.08.005']
1874,32865079,Participant Satisfaction with Computer-Delivered Intervention Components and Its Relation to Alcohol Outcomes.,"BACKGROUND


Few computer-delivered brief intervention (CDBI) studies have evaluated participant satisfaction with individual elements of the intervention, or whether participant satisfaction impacts intervention outcomes.  Purpose:  This factorial trial examined whether subjective reactions to a CDBI for heavy drinking (1) varied depending on the presence versus absence of an animated narrator, a spoken voice, empathic reflections, and motivational interviewing (MI) strategies and (2) were associated with drinking outcomes at 3-month follow-up.  Methods:  Participants were 352 heavy drinking university students. All participants were randomly assigned to one of 16 versions of a CDBI. After finishing the CDBI, participants completed measures of intervention likability and perceived empathy. Alcohol use outcomes were assessed at 3-month follow-up.  Results:  CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy. However, higher likeability ratings were associated with decreases in alcohol use outcomes over the 3-month assessment period.  Conclusions:  Results indicate that subjective reactions to CDBIs can have important effects on alcohol use outcomes.",2020,CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy.,['Participants were 352 heavy drinking university students'],[],"['intervention likability and perceived empathy', 'higher likeability ratings', 'participant ratings of likeability and perceived empathy']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0194355,CDBI characteristics had minimal effects on participant ratings of likeability and perceived empathy.,"[{'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Fodor', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Grekin', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Beatty', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McGoron', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ondersma', 'Affiliation': 'Merrill Palmer Skillman Institute, Wayne State University, Detroit, Michigan, USA.'}]",Substance use & misuse,['10.1080/10826084.2020.1811343']
1875,32865108,Telemedicine: An Innovative Twist to Primary Health Care in Rural Bangladesh.,"BACKGROUND


Health care service is worsening in the remote villages due to less complete and further away of healthcare facilities and service and makes this service costs compared to those of urban people. Telemedicine service provides a potential solution regarding this particular issue. This study provides empirical evidence of the benefits package consists of hypothetical telemedicine service and evaluates the economic benefit of telemedicine service.
METHODS


The study measures marginal willingness-to-pay (MWTP) responses to policy change on a sample (n = 203) observations. A randomized conjoint experiment has conducted in 7 remote villages of 3 coastal districts of the southwest coastal region of Bangladesh. Each respondent ranks 3 options-two hypothetical alternatives and the telemedicine status quo scheme. The level of attributes-payment for telemedicine service, sample collection from home, medicine delivery to home, capitation through online technology, service delivery frequency, and blood pressure and glucose measure at home-are randomly and jointly assigned to the 2 alternatives.
RESULTS AND CONCLUSIONS


Coastal villagers would like to pay more in option 4 and above. The lower payment for telemedicine service does not necessarily imply low demand for telemedicine, as the findings from MWTP illustrate potential demand for telemedicine in coastal villages in Bangladesh.",2020,"The lower payment for telemedicine service does not necessarily imply low demand for telemedicine, as the findings from MWTP illustrate potential demand for telemedicine in coastal villages in Bangladesh.","['Rural Bangladesh', '7 remote villages of 3 coastal districts of the southwest coastal region of Bangladesh', 'coastal villages in Bangladesh']",['Telemedicine'],['marginal willingness-to-pay (MWTP) responses'],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}]",203.0,0.0528938,"The lower payment for telemedicine service does not necessarily imply low demand for telemedicine, as the findings from MWTP illustrate potential demand for telemedicine in coastal villages in Bangladesh.","[{'ForeName': 'Md Hafiz', 'Initials': 'MH', 'LastName': 'Iqbal', 'Affiliation': 'Government Edward College, Pabna, Bangladesh.'}]",Journal of primary care & community health,['10.1177/2150132720950519']
1876,32858210,"A commentary on ""Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" [Int. J. Surg. 80 (2020) 13-18].",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Mingcheng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: ymc19950616@163.com.'}, {'ForeName': 'Zichuan', 'Initials': 'Z', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zichuanding@163.com.'}, {'ForeName': 'Zongke', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue Road, Chengdu, PR China. Electronic address: zongke2017@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.067']
1877,32858227,"The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial.","BACKGROUND AND OBJECTIVES


Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits. These ED visits are sentinel health events as discharged patients often return to the ED, experience declines in health-related quality of life (HRQoL) and disability, or are later hospitalized. Those who are admitted incur increased costs and greater risk for poor outcomes including infections, delirium, and falls. The objective of this randomized controlled trial (RCT) is to evaluate the efficacy of the Geriatric Emergency Department Innovations (GEDI) program, an ED nurse-led geriatric assessment and care coordination program, in decreasing unnecessary health services use and improving Health-Related Quality-of-Life (HRQoL) for older adults in the ED.
METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420). Outcome variables will be assessed during the ED visit and at 7-11 days and 28-32 days post ED visit.
PROJECTED OUTCOMES


The primary outcome is hospitalization or death within 30 days of the ED visit. Secondary outcomes include health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression].
TRIAL REGISTRATION


Clinicaltrials.Gov identifier NCT04115371.",2020,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","['Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either', 'older adults in the ED', 'Older adults (age 65 and older) use the emergency department (ED) at a rate of nearly 50 ED visits per 100 older adults, accounting for over 23 million ED visits in the US annually, up to 20% of all ED visits']","['Geriatric Emergency Department Innovations (GEDI', 'GEDI (n\u202f=\u202f420) or to usual ED care']","['health service use outcomes (ED visits and hospitalizations), healthcare costs, and HRQoL outcomes [Patient-Reported Outcomes Measurement Information System (PROMIS) scores: PROMIS-Preference, Physical Function, Ability to Participate in Social Roles and Activities, Anxiety, and Depression', 'hospitalization or death within 30\u202fdays of the ED visit', 'infections, delirium, and falls', 'Health-Related Quality-of-Life (HRQoL']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0547043', 'cui_str': 'Up'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517774', 'cui_str': '420'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.106207,"METHODS


Community dwelling older adults aged 65 and older who are vulnerable or frail according to the Clinical Frailty Scale (CFS) during an ED visit will be randomized to either GEDI (n = 420) or to usual ED care (n = 420).","[{'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Dresden', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. Electronic address: sdresden@nm.org.'}, {'ForeName': 'Alexander X', 'Initials': 'AX', 'LastName': 'Lo', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lee A', 'Initials': 'LA', 'LastName': 'Lindquist', 'Affiliation': 'Department of Internal Medicine, Division of General Internal Medicine and Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Masha', 'Initials': 'M', 'LastName': 'Kocherginsky', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lori Ann', 'Initials': 'LA', 'LastName': 'Post', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Buheler Center for Health Policy and Economics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'French', 'Affiliation': 'Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Ophthalmology, Feinberg School of Medicine, Northwestern University, USA; Department of Veterans Affairs Health Services Research and Development Service, Edward Hines, Jr. VA Hospital, Hines, IL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Division of Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Allen W', 'Initials': 'AW', 'LastName': 'Heinemann', 'Affiliation': 'Department of Emergency Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Center for Health Services and Outcomes Research, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University and Center for Rehabilitation Outcomes Research, Shirley Ryan AbilityLab, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106125']
1878,32860716,Canola oil compared with sesame and sesame-canola oil on glycaemic control and liver function in patients with type 2 diabetes: A three-way randomized triple-blind cross-over trial.,"BACKGROUND


This study aimed to compare the effects of sesame (SO), canola (CO), and sesame-canola (SCO: a blend) oils on glycaemic control markers and liver function enzymes in adults with type 2 diabetes.
METHODS


In this randomized, triple-blind, three-way, cross-over clinical trial, participants replaced their usual oil with the intervention oils for 9 weeks. Serum fasting blood sugar, fasting serum insulin (FSI), insulin resistance (HOMA2-IR), beta-cell function (HOMA2-%B), insulin sensitivity (HOMA2-%S), quantitative insulin sensitivity check index (QUICKI), as well as serum liver function enzymes were measured at baseline and end of intervention periods.
RESULTS


Ninety-two participants completed all treatment periods. After adjusting for confounders, all treatment oils resulted in significant improvements in FSI and HOMA2-%S (p < 0.05). SO and SCO led to favourable changes in HOMA2-IR and QUICKI (p < 0.05). Following CO and SCO, there was a significant decrease in HOMA2-%B (p < 0.05). The sex-stratified analysis revealed that FSI and HOMA2-IR were decreased after SO compared to CO in males (p = 0.024). Serum gamma-glutamyltransferase (GGT) was significantly lower following SO compared to CO in females (p = 0.02), however, the difference in change values was not significant (p = 0.058).
CONCLUSIONS


SO consumption appears to improve glycaemic control markers in males and serum GGT in females compared with CO in patients with type 2 diabetes (registration code: IRCT2016091312571N6).",2020,"Serum gamma-glutamyl transferase (GGT) was significantly lower following SO compared to CO in females (P=0.02), however, the difference in change values was not significant (P=0.058).
","['patients with type 2 diabetes', 'adults with type 2 diabetes mellitus (T2DM']","['sesame (SO), canola (CO), and sesame-canola (SCO: a blend) oils', 'canola oil compared with sesame and sesame-canola oil']","['glycemic control and liver function enzymes', 'FSI and HOMA2-IR', 'Serum fasting blood sugar (FBS), fasting serum insulin (FSI), insulin resistance (HOMA2-IR), beta-cell function (HOMA2-%B), insulin sensitivity (HOMA2-%S), quantitative insulin sensitivity check index (QUICKI), as well as serum liver function enzymes', 'FSI and HOMA2-%S', 'glycemic control markers and liver function enzymes', 'HOMA2-%B', 'glycemic control markers', 'Serum gamma-glutamyl transferase (GGT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1123051', 'cui_str': 'Sesame'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",92.0,0.0778848,"Serum gamma-glutamyl transferase (GGT) was significantly lower following SO compared to CO in females (P=0.02), however, the difference in change values was not significant (P=0.058).
","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Raeisi-Dehkordi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Zimorovat', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Moghtaderi', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Zarei', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, Manitoba, Canada.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Salehi-Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3399']
1879,32865229,Early Emotion Knowledge and Later Academic Achievement Among Children of Color in Historically Disinvested Neighborhoods.,"This study examined longitudinal relations between emotion knowledge (EK) in pre-kindergarten (pre-K; M age   = 4.8 years) and math and reading achievement 1 and 3 years later in a sample of 1,050 primarily Black children (over half from immigrant families) living in historically disinvested neighborhoods. Participants were part of a follow-up study of a cluster randomized controlled trial. Controlling for pre-academic skills, other social-emotional skills, sociodemographic characteristics, and school intervention status, higher EK at the end of pre-K predicted higher math and reading achievement test scores in kindergarten and second grade. Moderation analyses suggest that relations were attenuated among children from immigrant families. Findings suggest the importance of enriching pre-K programs for children of color with EK-promotive interventions and strategies.",2020,Moderation analyses suggest that relations were attenuated among children from immigrant families.,"['pre-kindergarten (pre-K; M age  \xa0=\xa04.8\xa0years) and math and reading achievement 1 and 3\xa0years later in a sample of 1,050 primarily Black children (over half from immigrant families) living in historically disinvested neighborhoods', 'children from immigrant families', 'Children of Color in Historically Disinvested Neighborhoods']",[],"['social-emotional skills, sociodemographic characteristics, and school intervention status, higher EK', 'Early Emotion Knowledge and Later Academic Achievement', 'emotion knowledge (EK']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",1050.0,0.0206447,Moderation analyses suggest that relations were attenuated among children from immigrant families.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ursache', 'Affiliation': 'NYU Groosman School of Medicine.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kiely Gouley', 'Affiliation': 'NYU Groosman School of Medicine.'}, {'ForeName': 'Spring', 'Initials': 'S', 'LastName': 'Dawson-McClure', 'Affiliation': 'NYU Groosman School of Medicine.'}, {'ForeName': 'R Gabriela', 'Initials': 'RG', 'LastName': 'Barajas-Gonzalez', 'Affiliation': 'NYU Groosman School of Medicine.'}, {'ForeName': 'Esther J', 'Initials': 'EJ', 'LastName': 'Calzada', 'Affiliation': 'University of Texas at Austin.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Goldfeld', 'Affiliation': 'NYU Groosman School of Medicine.'}, {'ForeName': 'Laurie M', 'Initials': 'LM', 'LastName': 'Brotman', 'Affiliation': 'NYU Groosman School of Medicine.'}]",Child development,['10.1111/cdev.13432']
1880,32861306,Effect of collaborative care between traditional and faith healers and primary health-care workers on psychosis outcomes in Nigeria and Ghana (COSIMPO): a cluster randomised controlled trial.,"BACKGROUND


Traditional and faith healers (TFH) provide care to a large number of people with psychosis in many sub-Saharan African countries but they practise outside the formal mental health system. We aimed to assess the effectiveness and cost-effectiveness of a collaborative shared care model for psychosis delivered by TFH and primary health-care providers (PHCW).
METHODS


In this cluster-randomised trial in Kumasi, Ghana and Ibadan, Nigeria, we randomly allocated clusters (a primary care clinic and neighbouring TFH facilities) 1:1, stratified by size and country, to an intervention group or enhanced care as usual. The intervention included a manualised collaborative shared care delivered by trained TFH and PHCW. Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60). The primary outcome, by masked assessments at 6 months, was the difference in psychotic symptom improvement as measured with the PANSS in patients in follow-up at 3 and 6 months. Patients exposure to harmful treatment practices, such as shackling, were also assessed at 3 and 6 months. Care costs were assessed at baseline, 3-month and 6-month follow-up, and for the entire 6 months of follow-up. This trial was registered with the National Institutes of Health Clinical Trial registry, NCT02895269.
FINDINGS


Between Sept 1, 2016, and May 3, 2017, 51 clusters were randomly allocated (26 intervention, 25 control) with 307 patients enrolled (166 [54%] in the intervention group and 141 [46%] in the control group). 190 (62%) of participants were men. Baseline mean PANSS score was 107·3 (SD 17·5) for the intervention group and 108·9 (18·3) for the control group. 286 (93%) completed the 6-month follow-up at which the mean total PANSS score for intervention group was 53·4 (19·9) compared with 67·6 (23·3) for the control group (adjusted mean difference -15·01 (95% CI -21·17 to -8·84; 0·0001). Harmful practices decreased from 94 (57%) of 166 patients at baseline to 13 (9%) of 152 at 6 months in the intervention group (-0·48 [-0·60 to -0·37] p<0·001) and from 59 (42%) of 141 patients to 13 (10%) of 134 in the control group (-0·33 [-0·45 to -0·21] p<0·001), with no significant difference between the two groups. Greater reductions in overall care costs were seen in the intervention group than in the control group. At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group). Five patients in the intervention group had mild extrapyramidal side effects.
INTERPRETATION


A collaborative shared care delivered by TFH and conventional health-care providers for people with psychosis was effective and cost-effective. The model of care offers the prospect of scaling up improved care to this vulnerable population in settings with low resources.
FUNDING


US National Institute of Mental Health.",2020,"At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group).","['Nigeria and Ghana (COSIMPO', '190 (62%) of participants were men', 'Eligible participants were adults (aged ≥18 years) newly admitted to TFH facilities with active psychotic symptoms (positive and negative syndrome scale [PANSS] score ≥60']","['Traditional and faith healers (TFH) provide care', 'intervention group or enhanced care as usual', 'collaborative care between traditional and faith healers and primary health-care workers', 'collaborative shared care model', 'manualised collaborative shared care delivered by trained TFH and PHCW']","['total health service and time costs', 'psychotic symptom improvement', 'Care costs', 'Harmful practices', 'effectiveness and cost-effectiveness', 'mean total PANSS score', 'cumulative costs', 'mild extrapyramidal side effects', 'overall care costs', 'Baseline mean PANSS score']","[{'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0335030', 'cui_str': 'Faith healer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0335030', 'cui_str': 'Faith healer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",307.0,0.145641,"At the 6 month assessment, greater reductions in total health service and time costs were seen in the intervention group; however, cumulative costs over this period were higher (US $627 per patient vs $526 in the control group).","[{'ForeName': 'Oye', 'Initials': 'O', 'LastName': 'Gureje', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria. Electronic address: ogureje@com.ui.edu.ng.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Appiah-Poku', 'Affiliation': 'Department of Behavioural Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'Toyin', 'Initials': 'T', 'LastName': 'Bello', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Kola', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Department of Health Services and Population Research, King's College London, London, UK.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Oluyomi', 'Initials': 'O', 'LastName': 'Esan', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Harris', 'Affiliation': 'Department of Psychiatry, University of Liberia, Monrovia, Liberia.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Makanjuola', 'Affiliation': 'WHO Collaborating Centre for Research and Training in Mental Health, Neurosciences and Substance Abuse, Department of Psychiatry, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Othieno', 'Affiliation': 'Department of Psychiatry, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'LeShawndra', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'Department of Health and Human Services, National Institute of Mental Health, National Institutes of Health, US Department of Health and Human Services, Bethesda, MD, USA.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Seedat', 'Affiliation': 'Department of Psychiatry, Stellenbosch University, Cape Town, South Africa.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30634-6']
1881,32861983,Can 'floating' predict treatment response to ketamine? Data from three randomized trials of individuals with treatment-resistant depression.,"Ketamine has rapid-acting antidepressant properties but also potentially concerning transient dissociative side effects (SEs). Recent studies noted a positive correlation between treatment response to ketamine and general dissociative SEs, as well as ""floating"", a depersonalization SE (a subtype of the dissociative SEs). This analysis sought to determine whether floating mediates treatment response to ketamine. Data were pooled from three double-blind, crossover, placebo-controlled ketamine clinical trials across which 82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder) received placebo and ketamine (0.5 mg/kg) infusions. SEs were actively solicited in a standardized fashion before and after ketamine infusion. The hypothesis that a post-infusion experience of floating would mediate antidepressant response to ketamine was assessed at 230 min post-infusion and at Day 1. Montgomery-Asberg Depression Rating Scale (MADRS) total score was the dependent variable in a linear mixed effects model. Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion. The hypothesized mediation effect of floating was also not detected at either 230 min or Day 1 post-infusion. Taken together, the findings do not support the hypothesis that ketamine's antidepressant effects are mediated by the dissociative depersonalization subtype SE of floating.",2020,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","['82 participants with treatment-resistant depression (TRD) (44 with bipolar depression and 38 with major depressive disorder', 'individuals with treatment-resistant depression']","['placebo and ketamine', 'ketamine', 'placebo-controlled ketamine', 'Ketamine']","['MADRS scores', 'floating and MADRS score', 'Montgomery-Asberg Depression Rating Scale (MADRS) total score']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",82.0,0.226109,"Ketamine significantly decreased MADRS scores (p < 0.0001), but no relationship was detected between floating and MADRS score at either 230 min or Day 1 post-infusion.","[{'ForeName': 'Elia E', 'Initials': 'EE', 'LastName': 'Acevedo-Diaz', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. Electronic address: elia.acevedo@gmail.com.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Cavanaugh', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Dede', 'Initials': 'D', 'LastName': 'Greenstein', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.012']
1882,32862007,Intranasal oxytocin increases respiratory rate and reduces obstructive event duration and oxygen desaturation in obstructive sleep apnea patients: a randomized double blinded placebo controlled study.,"BACKGROUND


Activation of the oxytocin network has shown benefits in animal models of Obstructive Sleep Apnea (OSA) as well as other cardiorespiratory diseases. We sought to determine if nocturnal intranasal oxytocin administration could have beneficial effects in reducing the duration and/or frequency of obstructive events in obstructive sleep apnea subjects.
METHODS


Two sequential standard ""in-lab"" polysomnogram (PSG) sleep studies were performed in patients diagnosed with OSA that were randomly assigned to initially receive either placebo or oxytocin (40 i.u.) administered intranasally in this double blinded randomized placebo controlled study. Changes in cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate were assessed in 2 h epochs following sleep onset. Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events. Notably, oxytocin increased respiratory rate during non-obstructive periods. There were no significant changes in sleep architecture and no adverse effects were reported.
CONCLUSIONS


Oxytocin administration can benefit OSA subjects by reducing the duration and adverse consequences of obstructive events. Oxytocin could also be beneficial in situations involving respiratory depression as oxytocin increased respiratory rate. Additional studies are needed to further understand the mechanisms by which oxytocin promotes these changes in cardiorespiratory function. The long-term efficacy and optimal dose of intranasal oxytocin treatment should also be determined in OSA subjects. ClinicalTrials.gov NCT03148899.",2020,"Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events.","['obstructive sleep apnea subjects', 'Two sequential standard ""in-lab"" polysomnogram (PSG', 'obstructive sleep apnea patients', 'patients diagnosed with OSA', 'OSA subjects']","['oxytocin network', 'intranasal oxytocin', 'oxytocin', 'nocturnal intranasal oxytocin', 'placebo', 'Oxytocin', 'placebo or oxytocin', 'Intranasal oxytocin']","['duration of obstructive events', 'respiratory rate', 'cardiorespiratory events during sleep, including apnea and hypopnea durations and frequency, risk of event-associated bradycardias, arterial oxygen desaturation and respiratory rate', 'respiratory rate and reduces obstructive event duration and oxygen desaturation', 'oxygen desaturations and incidence of bradycardia', 'sleep architecture and no adverse effects']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0853204', 'cui_str': 'No adverse effect'}]",,0.200305,"Oxytocin significantly decreased the duration of obstructive events, as well as the oxygen desaturations and incidence of bradycardia that were associated with these events.","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kimbro', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Kowalik', 'Affiliation': 'Department of Biomedical Engineering, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Milojevic', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Maritza Dowling', 'Affiliation': 'Department of Acute & Chronic Care, School of Nursing, Department of Epidemiology & Biostatistics, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Anne Lloyd', 'Initials': 'AL', 'LastName': 'Hunley', 'Affiliation': 'Department of Medicine, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hauser', 'Affiliation': 'Department of Pharmacology and Physiology, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Andrade', 'Affiliation': 'Centro de Fisiología Del Ejercicio, Universidad Mayor, Santiago, Chile; Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Del Rio', 'Affiliation': 'Laboratory of Cardiorespiratory Control, Department of Physiology, Pontificia Universidad Católica de Chile, Santiago, Chile; Center for Aging and Regeneration (CARE-UC), Pontificia Universidad Católica de Chile, Santiago, Chile; Centro de Excelencia de Biomedicina en Magallanes (CEBIMA), Universidad de Magallanes, Punta Arenas, Chile.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Kay', 'Affiliation': 'Department of Biomedical Engineering, The George Washington University, Washington, DC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mendelowitz', 'Affiliation': 'Department of Pharmacology and Physiology, The George Washington University, Washington, DC, USA. Electronic address: dmendel@gwu.edu.'}]",Sleep medicine,['10.1016/j.sleep.2020.05.034']
1883,32862009,Altered cortical gray matter volume and functional connectivity after transcutaneous spinal cord direct current stimulation in idiopathic restless legs syndrome.,"OBJECTIVE


To explore the neurophysiological mechanism of clinically effective transcutaneous spinal cord direct current stimulation (tsDCS) on idiopathic restless legs syndrome (RLS), structural magnetic resonance imaging (sMRI), and resting-state functional MRI (rs-fMRI) were applied to reveal the structural and functional changes in idiopathic RLS patients after tsDCS.
METHODS


Thirty idiopathic RLS patients and 20 gender- and age-matched healthy controls (HC) were enrolled. All patients were randomly divided into anodal treatment group and sham treatment group and were treated with tsDCS for 2 weeks. The international RLS Rating Scale (IRLS-RS) and Pittsburgh Sleep Quality Index (PSQI) were used to evaluate the severity of RLS and sleep quality respectively. The sMRI and rs-fMRI data of anodal treatment group and HC were collected. Voxel-based morphology (VBM) and resting-state functional connectivity analysis were used to assess the change of cortical gray matter volume (GMV) and corresponding functional connectivity (FC) respectively in anodal treatment group after tsDCS treatment.
RESULTS


Sham treatment group showed no significant change in IRLS-RS and PSQI scores after tsDCS, while significant decrease scores were observed in anodal treatment group, and the improvement sustained up to 2 weeks. Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC. After tsDCS treatment, the GMV in the bilateral cuneus and left ventral post central gyrus (PoCG_L) decreased significantly. The FC between bilateral cuneus and left primary visual cortex (V1_L), and between right cuneus (Cune_R) and right lingual gyrus (LG_R) increased significantly after tsDCS, whereas the FC between PoCG_L and supplementary motor area (SMA) decreased significantly. The changed FC between PoCG_L and SMA, between Cune_R and V1_L were correlated with the changed IRLS-RS.
CONCLUSION


Disturbance of sensorimotor network and visual processing network may be involved in the pathogenesis of RLS. tsDCS probably can regulate FC in the sensorimotor cortex and visual processing cortex to relieve the symptom of RLS. Continuous tsDCS may improve the symptoms of RLS patients for a long time. tsDCS probably could provide a potential non-pharmacologic treatment for idiopathic RLS patients.",2020,Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC.,"['idiopathic restless legs syndrome (RLS', 'idiopathic RLS patients after tsDCS', 'idiopathic restless legs syndrome', 'idiopathic RLS patients', 'Thirty idiopathic RLS patients and 20 gender- and age-matched healthy controls (HC) were enrolled']","['transcutaneous spinal cord direct current stimulation (tsDCS', 'transcutaneous spinal cord direct current stimulation', 'anodal treatment group and sham treatment group and were treated with tsDCS', 'tsDCS']","['change of cortical gray matter volume (GMV) and corresponding functional connectivity (FC', 'international RLS Rating Scale (IRLS-RS) and Pittsburgh Sleep Quality Index (PSQI', 'bilateral cuneus and left ventral post central gyrus (PoCG_L', 'FC between PoCG_L and supplementary motor area (SMA', 'IRLS-RS and PSQI scores', 'regional decrease of GMV in bilateral cuneus', 'FC between bilateral cuneus and left primary visual cortex (V1_L), and between right cuneus (Cune_R) and right lingual gyrus (LG_R']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152307', 'cui_str': 'Structure of cuneus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038446', 'cui_str': 'Area striata structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}]",30.0,0.0317877,Anodal treatment group showed significant regional decrease of GMV in bilateral cuneus compared to the HC.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Shuqin', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China.'}, {'ForeName': 'Jiaojian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Life Science and Technology, University of Electronic Science and Technology of China, Chengdu, China. Electronic address: jiaojianwang@uestc.edu.com.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China; Beijing Key Laboratory of Neuromodulation, Beijing, China; Beijing Institute of Brain Disorders, Capital Medical University, China. Electronic address: wangyuping01@sina.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.026']
1884,32862111,Interferon β-1b in treatment of severe COVID-19: A randomized clinical trial.,"In this study, efficacy and safety of interferon (IFN) β-1b in the treatment of patients with severe COVID-19 were evaluated. Among an open-label, randomized clinical trial, adult patients (≥18 years old) with severe COVID-19 were randomly assigned (1:1) to the IFN group or the control group. Patients in the IFN group received IFN β-1b (250 mcg subcutaneously every other day for two consecutive weeks) along with the national protocol medications while in the control group, patients received only the national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine for 7-10 days). The primary outcome of the study was time to clinical improvement. Secondary outcomes were in-hospital complications and 28-daymortality. Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study. Time to clinical improvment in the IFN group was significantly shorter than the control group ([9(6-10) vs. 11(9-15) days respectively, p = 0.002, HR = 2.30; 95% CI: 1.33-3.39]). At day 14, the percentage of discharged patients was 78.79% and 54.55% in the IFN and control groups respectively (OR = 3.09; 95% CI: 1.05-9.11, p = 0.03). ICU admission rate in the control group was significantly higher than the IFN group (66.66% vs. 42.42%, p = 0.04). The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (p = 0.12). IFN β-1b was effective in shortening the time to clinical improvement without serious adverse events in patients with severe COVID-19. Furthermore, admission in ICU and need for invasive mechanical ventilation decreased following administration of IFN β-1b. Although 28-day mortality was lower in the IFN group, further randomized clinical trials with large sample size are needed for exact estimation of survival benefit of IFN β-1b.",2020,The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (,"['patients with severe COVID-19', 'severe COVID-19', 'patients with severe COVID-19 were evaluated', 'adult patients (≥18\xa0years old) with severe COVID-19', 'Between April 20 and May 20, 2020, 80 patients were enrolled and finally 33 patients in each group completed the study']","['interferon (IFN) β-1b', 'IFN', 'IFN β-1b', 'national protocol medications (lopinavir/ritonavir or atazanavir/ritonavir plus hydroxychloroquine', 'Interferon β-1b']","['ICU admission rate', 'Time to clinical improvment', '28-day mortality', 'invasive mechanical ventilation', 'hospital complications and 28-daymortality', 'duration of hospitalization and ICU stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",80.0,0.104399,The duration of hospitalization and ICU stay were not significantly different between the groups All-cause 28-day mortality was 6.06% and 18.18% in the IFN and control groups respectively (,"[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: khalilih@tums.ac.ir.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Hajizadeh', 'Affiliation': 'Department of Infectious Diseases, Shohadaye Gomnam Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Narjes Zarei', 'Initials': 'NZ', 'LastName': 'Jalalabadi', 'Affiliation': 'Department of Internal Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fazeli', 'Affiliation': 'Department of Food and Drug Control, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Monireh', 'Initials': 'M', 'LastName': 'Ghazaeian', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran Univesity of Medical Sciences, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106903']
1885,32868350,Predicting the use of antibiotics after initial symptomatic treatment of an uncomplicated urinary tract infection: analyses performed after a randomised controlled trial.,"OBJECTIVE


To predict antibiotic use after initial treatment with ibuprofen using data from a randomised controlled trial comparing ibuprofen to pivmecillinam in the treatment of women with symptoms of an uncomplicated urinary tract infection (UTI).
SETTING


16 sites in a primary care setting in Norway, Sweden and Denmark.
PARTICIPANTS


Data from 181 non-pregnant women aged 18-60 presenting with symptoms of uncomplicated UTI, initially treated with ibuprofen.
METHODS


Using the least absolute shrinkage and selection operator logistic regression model, we conducted analyses to see if baseline information could help us predict which women could be treated with ibuprofen without risking treatment failure and which women should be recommended antibiotics.
RESULTS


Of the 143 women included in the final analysis, 77 (53.8%) recovered without antibiotics and 66 (46.2 %) were subsequently prescribed antibiotics. In the unadjusted binary logistic regression, the number of days with symptoms before inclusion (<3 days) and feeling moderately unwell or worse (≥4 on a scale of 0-6) were significant predictors for subsequent antibiotic use. In the adjusted model, no predictors were significantly associated with subsequent antibiotic use. The area under the curve of the final model was 0.66 (95% CI: 0.57 to 0.74).
CONCLUSION


We did not find any baseline information that significantly predicted the use of antibiotic treatment. Identifying women who need antibiotic treatment to manage their uncomplicated UTI is still challenging. Larger data sets are needed to develop models that are more accurate.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov (NCT01849926).",2020,"The area under the curve of the final model was 0.66 (95% CI: 0.57 to 0.74).
","['143 women included in the final analysis, 77 (53.8%) recovered without antibiotics and 66 (46.2 %) were subsequently prescribed antibiotics', 'uncomplicated urinary tract infection', '16 sites in a primary care setting in Norway, Sweden and Denmark', 'Data from 181 non-pregnant women aged 18-60 presenting with symptoms of uncomplicated UTI, initially treated with', 'women with symptoms of an uncomplicated urinary tract infection (UTI']",['ibuprofen'],[],"[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]",[],181.0,0.154871,"The area under the curve of the final model was 0.66 (95% CI: 0.57 to 0.74).
","[{'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Vik', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway ingvild.vik@medisin.uio.no.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bollestad', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gloria Cristina', 'Initials': 'GC', 'LastName': 'Cordoba', 'Affiliation': 'Section of General Practice and Research Unit of General Practice, Department of Public Health, University of Copenhagen, København, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'Section of General Practice and Research Unit of General Practice, Department of Public Health, University of Copenhagen, København, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neumark', 'Affiliation': 'Primary Health Care and Planning Division, Kalmar County Council, Kalmar, Sweden.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Damsgaard', 'Affiliation': 'Bergen Accident and Emergency Department, Bergen Kommune, Bergen, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bærheim', 'Affiliation': 'Department of Global Public Health and Primary Care, University of Bergen, Bergen, Hordaland, Norway.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Grude', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindbaek', 'Affiliation': 'Department of General Practice, Antibiotic Centre for Primary Care, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-035074']
1886,32868354,Point-of-care viral load testing among adolescents and youth living with HIV in Haiti: a protocol for a randomised trial to evaluate implementation and effect.,"INTRODUCTION


Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression.
METHODS AND ANALYSIS


This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence.
ETHICS AND DISSEMINATION


This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
TRIAL REGISTRATION NUMBER


NCT03288246.",2020,"If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
","['Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes', 'adolescents and youth living with HIV in Haiti', '150 participants ages 10-24 who have been on ART for >6 months']","['POC VL testing', 'POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling', 'standard laboratory-based VL testing', 'laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1\u2009month later, at which time they receive ART adherence counselling']",['VL suppression'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",150.0,0.15321,"If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV.
","[{'ForeName': 'Lindsey K', 'Initials': 'LK', 'LastName': 'Reif', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA lir2020@med.cornell.edu.'}, {'ForeName': 'Marie Elmase', 'Initials': 'ME', 'LastName': 'Belizaire', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Seo', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rouzier', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Severe', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Joseph Marie', 'Initials': 'JM', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Joseph', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Apollon', 'Affiliation': 'GHESKIO, Port-au-Prince, Ouest, Haiti.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Elul', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Jean W', 'Initials': 'JW', 'LastName': 'Pape', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNairy', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Fitzgerald', 'Affiliation': 'Center for Global Health, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'ICAP at Columbia University, Mailman School of Public Health, Columbia University Irving Medical Center, New York, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-036147']
1887,32868356,R eaching m E thadone users  A ttending  C ommunity p H armacies with HCV: an international cluster randomised controlled trial protocol (REACH HCV).,"INTRODUCTION


Hepatitis C virus (HCV) is a global public health threat, and novel models of care are required to treat those currently or previously at highest risk of infection, particularly persons who inject drugs (PWID; ever injected), as conventional healthcare models do not have the reach to deliver cure of HCV to disadvantaged, disproportionately affected communities. In Western Europe and Australasia, it is estimated that HCV affects between 0.4% and 1.0% of the regions' populations, accordingly, it affects between 0.4% and 0.7% of the populations of countries in this study (Scotland, Wales and Australia).  R eaching m E thadone users  A ttending  C ommunity p H armacies with HCV (REACH HCV) will evaluate community pharmacy-based diagnostic outreach and HCV treatment against conventional HCV testing and treatment pathways for clients receiving opioid substitution therapy (OST) in community pharmacies.
METHODS AND ANALYSIS


REACH HCV is an international multicentre cluster randomised controlled trial with sites in Scotland, Wales and Australia. The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway. Participants are recruited from OST clients in these pharmacies.In the pharmacy intervention pathway, participants receive a rapid point-of-care HCV PCR test in their pharmacy by a study outreach nurse. If positive, direct-acting antivirals (DAAs) are delivered to participants via their pharmacist in line with their OST schedule.In the education-only pathway, pharmacists counsel OST clients on HCV and refer them to the nearest nurse-led clinic or general practitioner offering HCV testing according to standard care protocols. If positive, DAAs are delivered as in the intervention pathway.The primary endpoint for both pathways is sustained viral response at 12 weeks post-treatment . Secondary outcomes are: cost-efficacy by pathway; participants tested by pathway; adherence to therapy by pathway and impact of blood test results on treatment decisions.A statistical analysis plan will be finalised prior to data lock. Analysis will be by intention to treat (ITT) to show superiority. Modified ITT analysis will also be undertaken to explore the steps in the pathways.
ETHICS AND DISSEMINATION


The trial received ethical favourable opinion from the East of Scotland Research Ethics Committee 2 (19/ES/0025) for UK sites and approval from the Alfred Hospital Ethics Committee (148/19) for Australian sites and complies with principles of Good Clinical Practice. Final results will be presented in peer-reviewed journals and at relevant conferences.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry NCT03935906.
PROTOCOL VERSION


V.4.0-19 March 2020.",2020,The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway.,"['VERSION\n\n\nV.4.0-19 March 2020', 'clients receiving opioid substitution therapy (OST) in community pharmacies', 'Participants are recruited from OST clients in these pharmacies']","['direct-acting antivirals (DAAs', 'R eaching m E thadone users  A ttending  C ommunity p H armacies with HCV', 'HCV', 'pharmacy intervention pathway or the education-only (control) pathway', 'rapid point-of-care HCV PCR test', 'HCV (REACH HCV']","['sustained viral response', 'cost-efficacy by pathway; participants tested by pathway; adherence to therapy by pathway and impact of blood test results on treatment decisions']","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}]","[{'cui': 'C3653501', 'cui_str': 'DIRECT ACTING ANTIVIRALS'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}]","[{'cui': 'C3888663', 'cui_str': 'Sustained viral response'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.122577,The sites are community pharmacies which are randomised equally to one of two pathways: the pharmacy intervention pathway or the education-only (control) pathway.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Byrne', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Dundee School of Medicine, Dundee, UK c.x.byrne@dundee.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Dundee School of Medicine, Dundee, UK.'}, {'ForeName': 'Sarah Karen', 'Initials': 'SK', 'LastName': 'Inglis', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Lewis J Z', 'Initials': 'LJZ', 'LastName': 'Beer', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Nicki', 'Initials': 'N', 'LastName': 'Palmer', 'Affiliation': 'Public Health Wales Department of Microbiology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Minh Duc', 'Initials': 'MD', 'LastName': 'Pham', 'Affiliation': 'Disease Elimination Programme, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Healy', 'Affiliation': 'Public Health Wales Department of Microbiology, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Doyle', 'Affiliation': 'Disease Elimination Programme, Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Donnan', 'Affiliation': 'Dundee Epidemiology and Biostatistics Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dillon', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Dundee School of Medicine, Dundee, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036501']
1888,32868360,Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study).,"INTRODUCTION


Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings.
METHODS AND ANALYSIS


RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA.
ETHICS AND DISSEMINATION


This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities.
TRIAL REGISTRATION DETAILS


Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018.",2020,"Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%.","['20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20', 'Australian New Zealand Clinical Trials Registry']","['ivermectin', 'Ivermectin', 'ivermectin-based MDA', 'ivermectin-based mass drug administration (MDA']","['impetigo prevalence', 'prevalence of scabies', 'global morbidity']","[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0162627', 'cui_str': 'Bacterial infection of skin'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.330964,"Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%.","[{'ForeName': 'Susanna J', 'Initials': 'SJ', 'LastName': 'Lake', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Sophie L', 'Initials': 'SL', 'LastName': 'Phelan', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Engelman', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sokana', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Titus', 'Initials': 'T', 'LastName': 'Nasi', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Dickson', 'Initials': 'D', 'LastName': 'Boara', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gorae', 'Affiliation': 'Ministry of Health and Medical Services, Honiara, Solomon Islands.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Schuster', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anneke C', 'Initials': 'AC', 'LastName': 'Grobler', 'Affiliation': 'Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Millicent H', 'Initials': 'MH', 'LastName': 'Osti', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Australian National University, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Margot J', 'Initials': 'MJ', 'LastName': 'Whitfeld', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, Sydney, New South Wales, Australia.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Romani', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kaldor', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Steer', 'Affiliation': 'Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia andrew.steer@rch.org.au.'}]",BMJ open,['10.1136/bmjopen-2020-037305']
1889,32871917,Comparison adductor canal block combined with local infiltration analgesia and adductor canal block alone for pain management after total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Pain control after total knee arthroplasty has shown many advances; however, the optimal method remains controversial. The purpose of this present study is to assess the efficacy and safety of the addition of local infiltration analgesia to adductor canal block for pain control after primary total knee arthroplasty.
METHODS


This prospective randomized controlled research was conducted from January 2018 to June 2019. All the patients and their family members signed the informed consent forms, and this work was authorized via the ethics committee of Jinxiang Hospital Affiliated to Jining Medical College (JXHP0024578). Inclusion criteria were 55 years old or older, who possess the physical status I-III of American Society of Anesthesiologists, and the body mass index in the range of 18 to 30 kg/m. Exclusion criteria were regional and/or neuroaxial anesthesia contraindications, the history of drug allergy involved in the research, neuropathic pain, as well as the chronic pain requiring opioid therapy. Seventy-two patients were divided into 2 groups randomly. Study group (n = 36) received both adductor canal block and local infiltration analgesia. Control group (n = 36) received adductor canal block alone. Primary outcome included postoperative pain score (visual analog scale 0 to 10 cm, in which 0 represents no pain and 10 represents the most severe imaginable pain). The measures of secondary outcome included the knee range of motion, opioid consumption, the hospital stay length as well as the postoperative complications (for instance, pulmonary embolism, deep vein thrombosis, and the wound infection). All the analyses were conducted through utilizing the SPSS for Windows Version 20.0.
RESULTS


The results will be shown in .(Table is included in full-text article.) CONCLUSION:: The study will provide more evidence on the combination use of adductor canal block and local infiltration analgesia in the treatment of pain after the total knee arthroplasty.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5832).",2020,Control group (n = 36) received adductor canal block alone.,"['pain control after primary total knee arthroplasty', 'pain after the total knee arthroplasty', 'January 2018 to June 2019', 'Inclusion criteria were 55 years old or older, who possess the physical status I-III of American Society of Anesthesiologists, and the body mass index in the range of 18 to 30\u200akg/m', 'Seventy-two patients', 'pain management after total knee arthroplasty']","['local infiltration analgesia to adductor canal block', 'adductor canal block alone', 'adductor canal block and local infiltration analgesia', 'Comparison adductor canal block combined with local infiltration analgesia and adductor canal block alone']","['knee range of motion, opioid consumption, the hospital stay length as well as the postoperative complications (for instance, pulmonary embolism, deep vein thrombosis, and the wound infection', 'efficacy and safety', 'postoperative pain score (visual analog scale 0 to 10\u200acm, in which 0 represents no pain and 10 represents the most severe imaginable pain']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",72.0,0.0783024,Control group (n = 36) received adductor canal block alone.,"[{'ForeName': 'Qingchun', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Jinxiang Hospital Affiliated to Jining Medical College, Shandong, China.'}, {'ForeName': 'Limei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021881']
1890,32871923,"Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: A multi-center, randomized, double-blind, controlled trial.","INTRODUCTION


Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by a relapsing-remitting course owing to recurrent intestinal inflammation. UC often has symptoms such as intermittent rectal bleeding, diarrhea, and abdominal pain. As the precise etiology of UC has not completely clarified, UC has become a public health challenge worldwide. According to an epidemiological survey, there were about 350,000 new cases of IBD in China from 2005 to 2014. By 2025, the number of IBD patients in China will reach 1.5 million. Traditional Chinese medicine (TCM) has been widely used to treat UC in China, however, it is still challenging to systematically determine the efficacy of in UC. Therefore, this trial aims to evaluate the clinical efficacy and safety of CHM in the treatment of mild active UC patients.
METHODS


A multi-center, double-blinding, double-dummy, active-controlled, randomized trial will be established. A total of 240 patients in 6 centers with mild active UC (Mayo score is 3-5 points) and TCM syndrome of damp-heat stasis blocking and spleen-qi deficiency will be randomly allocated in the ratio of 1:1 to 2 groups: the experimental group and the control group. The experimental group will receive Hudi enteric-coated capsules (HEC) and enteric-coated mesalazine tablets placebo; the control group will receive enteric-coated mesalazine tablets and HEC placebo. Each group will be treated for 8 weeks. The primary therapeutic outcome: the rate of clinical efficacy and clinical remission at 8 weeks of treatment (last survey point) according to the modified Mayo score. The secondary outcomes: individual symptom score, TCM syndrome score, endoscopic response rate, mucosal healing rate, and quality of life scale score. Outcomes will be assessed at baseline and the end of the trial. Besides, intestinal mucosa, stools and blood biopsies from the mild active UC patients before and after treatment will be collected to reveal the underlying mechanisms.
DISCUSSION


The results of this trial will provide compelling evidence of the efficacy and safety of HEC for treatment of mild active UC and preliminarily show the potential mechanism of how HEC acts. Finally, it will widen treatment options for patients with mild active UC.",2020,"The secondary outcomes: individual symptom score, TCM syndrome score, endoscopic response rate, mucosal healing rate, and quality of life scale score.","['mild active UC patients', '240 patients in 6 centers with mild active UC (Mayo score is 3-5 points) and TCM syndrome of damp-heat stasis blocking and spleen-qi deficiency', 'mild active ulcerative colitis', 'patients with mild active UC', '350,000 new cases of IBD in China from 2005 to 2014']","['Traditional Chinese medicine (TCM', 'traditional Chinese medicine', 'CHM', 'Hudi enteric-coated capsules (HEC) and enteric-coated mesalazine tablets placebo', 'mesalazine tablets and HEC placebo', 'HEC']","['symptom score, TCM syndrome score, endoscopic response rate, mucosal healing rate, and quality of life scale score', 'clinical efficacy and safety', 'intestinal mucosa, stools and blood biopsies', 'rate of clinical efficacy and clinical remission']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0008525', 'cui_str': 'Choroideremia'}, {'cui': 'C0991569', 'cui_str': 'Delayed Release Oral Capsule'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021839', 'cui_str': 'Intestinal mucous membrane structure'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.325835,"The secondary outcomes: individual symptom score, TCM syndrome score, endoscopic response rate, mucosal healing rate, and quality of life scale score.","[{'ForeName': 'Fu-Shun', 'Initials': 'FS', 'LastName': 'Kou', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'School of Life Sciences, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District, Beijing.'}, {'ForeName': 'Jun-Xiang', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.'}, {'ForeName': 'Zhi-Bin', 'Initials': 'ZB', 'LastName': 'Wang', 'Affiliation': 'Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Shi', 'Affiliation': 'Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.'}, {'ForeName': 'Tang-You', 'Initials': 'TY', 'LastName': 'Mao', 'Affiliation': 'Gastroenterology Department, Dongfang Hospital, Beijing University of Chinese Medicine, No. 6, 1st Section, Fangxingyuan, Fangzhuang, Fengtai District.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ke', 'Affiliation': ""Department of Spleen and Stomach Diseases, The Second People's Hospital affiliated to Fujian University of Traditional Chinese Medicine, 282 Wusi Lu, Fuzhou City, Fujian Province.""}, {'ForeName': 'Bei-Ping', 'Initials': 'BP', 'LastName': 'Zhang', 'Affiliation': 'Gastroenterology Department, The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, No. 111 Dade Road, Yuexiu District, Guangzhou.'}, {'ForeName': 'Xiao-Jun', 'Initials': 'XJ', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Chongqing Hospital of Traditional Chinese Medicine, No. 6, the 7th branch of Panxi road, Jiangbei District, Chongqing.'}, {'ForeName': 'Xin-Li', 'Initials': 'XL', 'LastName': 'Wen', 'Affiliation': ""Department of Gastroenterology, Shanxi Hospital of Traditional Chinese Medicine, No. 4, Xihuamen, Lianhu District, Xi'an Shanxi Province.""}, {'ForeName': 'Wei-Yang', 'Initials': 'WY', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, No. 1 shuaifuyuan, Dongdan, Dongcheng District, Beijing.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District.'}, {'ForeName': 'Pang-Hua', 'Initials': 'PH', 'LastName': 'Ding', 'Affiliation': 'Graduate School, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Central laboratory Department, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, No. 155, Hanzhong Road, Gulou District, Nanjing City, Jiangsu Province, PR China.'}]",Medicine,['10.1097/MD.0000000000021903']
1891,32871950,Evaluation of the efficacy of Conbercept in the treatment of diabetic macular edema based on OCTA.,"BACKGROUND


Diabetic macular edema (DME) can cause severe vision impairments for patients with diabetes. Recently, Conbercept has shown efficacy on DME with 3-monthly loading dose injection and pro re nata (PRN, 3+PRN) thereafter in retrospectivetrials. Furthermore, there are some other approaches have been recommended such as 2mg bimonthly (2q8) after 5 initial doses, or Conbercept 0.5mg treat-and-extend, however, some patients still have recurrence of the disease after treatment. Therefore, in order to identify more efficacy and safety approach on Conbercept inpatients with DME, a randomized controlled trial will be performed with 6-monthly loading dose injection and PRN (6+PRN) compared with 3+PRN treatments.
METHODS


This study is a multicenter, randomized control trial of Conbecept treating DME in China. Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited. All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.
RESULTS


This study will provide a new powerful evidence of the efficacy and safety of Conbecept treating DME.
DISCUSSION


This RTC study will determine whether multiple treatments of Conbercept provide better effectiveness in patients with DME.
TRIAL REGISTRATION NUMBER


ChiCTR2000032728.",2020,"All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.
","['patients with DME', 'diabetic macular edema based on OCTA', 'Conbercept inpatients with DME', 'Diabetic macular edema (DME', 'patients with diabetes', 'China', 'Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited']","['Conbecept treating DME', 'Conbercept', 'study agent treatment group (6+PRN) or a control group (3+PRN', 'PRN (6+PRN']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1833296', 'cui_str': 'CHMP2B-related frontotemporal dementia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0926971,"All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment.
","[{'ForeName': 'Teer', 'Initials': 'T', 'LastName': 'Ba', 'Affiliation': 'School of Public Health, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Xiaoguang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Shixuan', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Qiqige', 'Initials': 'Q', 'LastName': 'Caihan', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Bai', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Lao', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}, {'ForeName': 'Guisen', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Inner Mongolia Chaoju Eye Hospital, Hohhot, China.'}]",Medicine,['10.1097/MD.0000000000021992']
1892,32881071,Cognitive stimulation therapy for people with dementia in Brazil (CST-Brasil): Results from a single blind randomized controlled trial.,"OBJECTIVE


The prevalence of dementia has been increasing particularly in developing countries but care provision is still limited in these regions. Psychosocial interventions are recognized as useful tools to improve cognitive and behavioral difficulties, as well as quality of life of people with dementia (PwD) and their caregivers. Cognitive stimulation therapy (CST) is an evidence-based psychosocial intervention, recommended and implemented in many countries. In Brazil, there is no validated psychosocial intervention for dementia care. The present study aims to explore feasibility and obtain preliminary data on the efficacy of CST-Brasil in a sample of 47 people with mild to moderate dementia attending an outpatient unit.
METHODS


A single-blind design was used, with participants being randomly allocated to either 14 sessions of CST + treatment as usual (TAU; n = 23) or TAU (n = 24) during 7 weeks. Changes in cognition, quality of life, depressive symptoms, caregiver burden and functionality were measured.
RESULTS


PwD receiving CST and their family caregivers expressed good acceptance of the intervention, with low attrition and high attendance. Participants receiving CST exhibited significant improvements in mood and in activities of daily living compared to TAU. There were no significant effects in cognition, quality of life and caregiver burden.
CONCLUSIONS


CST-Brasil proved to be a feasible and useful intervention to improve mood in PwD, with high acceptance between study participators. CST-Brasil is a promising psychosocial intervention for dementia and should be explored in other clinical settings to allow generalization to a wider Brazilian context.",2020,Participants receiving CST exhibited significant improvements in mood and in ADL compared to TAU.,"['people with dementia in Brazil (CST-Brasil', '47 people with mild to moderate dementia attending an out-patient unit', 'people with dementia (PwD) and their caregivers']","['CST-Brasil', 'CST', 'Cognitive Stimulation Therapy', 'Cognitive Stimulation Therapy (CST', 'TAU']","['Changes in cognition, quality of life, depressive symptoms, caregiver burden and functionality', 'mood and in ADL', 'cognition, QoL and caregiver burden']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",47.0,0.111339,Participants receiving CST exhibited significant improvements in mood and in ADL compared to TAU.,"[{'ForeName': 'Valeska', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Bertrand', 'Affiliation': 'Department of Psychology, Pontifical Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Naylor', 'Affiliation': 'Department of Psychology, Pontifical Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Bomilcar', 'Affiliation': 'Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Jerson', 'Initials': 'J', 'LastName': 'Laks', 'Affiliation': 'Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Spector', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, London, UK.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Mograbi', 'Affiliation': 'Department of Psychology, Pontifical Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",International journal of geriatric psychiatry,['10.1002/gps.5421']
1893,32877557,Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial.,"BACKGROUND


A health department survey revealed nearly half employ laboratory-based HIV and HCV testing (LBT) over rapid testing (RT) in nonhospital settings such as drug detoxification centers. LBT has higher sensitivity for acute HIV infection compared to RT but LBT is not point of care and may result in fewer diagnoses due to loss to follow-up before result delivery.
METHODS


We conducted a randomized trial comparing real-world case notification of RT (Orasure) vs LBT (HIV Combo Ag/Ab EIA, HCV EIA) for HIV and HCV at a drug detoxification center. Primary outcome was receipt of test results within 2 weeks.
RESULTS


Among 341 individuals screened (11/2016-7/2017), 200 met inclusion criteria; 58% injected drugs and 31% shared needles in the previous 6 months. Of the 200 randomized, 98 received RT and 102 LBT. Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31). Real-world case notification was 95% and 93% for HIV and HCV RT, respectively, compared to 42% for HIV and HCV LBT.
CONCLUSIONS


RT has higher real-world case notification than LBT at drug detoxification centers.Clinical trials registration: NCT02869776.",2020,"Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31).","['341 individuals screened (11/2016-7/2017), 200 met inclusion criteria; 58% injected drugs and 31% shared needles in the previous 6 months']","['LBT', 'Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C', 'HCV testing (LBT) over rapid testing (RT', 'RT (Orasure) vs LBT (HIV Combo Ag/Ab EIA, HCV EIA']","['Real-world case notification', 'receipt of test results within 2 weeks']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0014661', 'cui_str': 'Swamp Fever'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0439230', 'cui_str': 'week'}]",,0.431165,"Among all participants, 0.5% were positive for HIV and 48% for HCV; 96% received test results in the RT arm and 42% in the LBT arm (odds ratio, 28.72; 95% confidence interval, 10.27-80.31).","[{'ForeName': 'Sabrina A', 'Initials': 'SA', 'LastName': 'Assoumou', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Paniagua', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': 'Section of Infectious Diseases, Department of Medicine, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'White', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Curt G', 'Initials': 'CG', 'LastName': 'Beckwith', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa162']
1894,32861015,Cognitive behavioral therapy for insomnia in restless legs syndrome patients.,"OBJECTIVES


The purpose of this study was to investigate the effects of cognitive behavioral therapy for insomnia (CBTI) in patients with Restless Legs Syndrome (RLS).
METHODS


This is a randomized controlled study. The patients were sequentially selected and randomly assigned to either a CBTI group or a non-CBTI group. A total of 25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center. Twelve were assigned to the CBTI group, and 13 were assigned to the non-CBTI group. The CBTI group received 4 sessions of behavioral therapy, while the non-CBTI group received one informative session on sleep hygiene. All patients completed sleep and psychiatric-related questionnaires. In addition, each individual completed a one-week sleep log for collecting subjective sleep data and actigraphy for objective sleep data.
RESULTS


After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group. The effect of CBTI on sleep-related data was maintained for up to three months.
CONCLUSIONS


CBTI was effective in RLS patients by improving sleep quality and anxiety symptoms. CBTI may be considered in clinical practice for RLS patients with comorbid insomnia.",2020,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","['restless legs syndrome patients', 'patients with Restless Legs Syndrome (RLS', 'RLS patients with comorbid insomnia', '25 RLS patients with comorbid insomnia were recruited from a tertiary university hospital sleep center']","['CBTI', 'CBTI group or a non-CBTI', 'cognitive behavioral therapy', 'Cognitive behavioral therapy']","['sleep quality and anxiety symptoms', 'severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety']","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",25.0,0.0273384,"After conducting the CBTI, there were significant improvements in severity of insomnia symptoms, subjective sleep efficiency, total sleep time, latency to sleep onset, wake after sleep onset, objective latency to sleep onset, and anxiety in the CBTI group as compared to the non-CBTI group.","[{'ForeName': 'Mei Ling', 'Initials': 'ML', 'LastName': 'Song', 'Affiliation': 'College of Nursing, Daegu Health College, Daegu, South Korea; College of Nursing, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Kyung Min', 'Initials': 'KM', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Keimyung University, Daegu, South Korea. Electronic address: kmp@kmu.ac.kr.'}, {'ForeName': 'Gholam K', 'Initials': 'GK', 'LastName': 'Motamedi', 'Affiliation': 'Department of Neurology, Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Yong Won', 'Initials': 'YW', 'LastName': 'Cho', 'Affiliation': 'Department of Neurology, Keimyung University, School of Medicine, Daegu, South Korea. Electronic address: neurocho@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2020.07.011']
1895,32861189,Time for bed! Earlier sleep onset is associated with longer nighttime sleep duration during infancy.,"OBJECTIVE/BACKGROUND


Clinical recommendations include putting infants to bed using a consistent bedtime routine at an appropriate hour to promote longer nighttime sleep. Actigraphy was used in this exploratory study to examine how bedtime routines and nighttime sleep onset were associated with nighttime total sleep time (TST) and efficiency from 6 to 24 weeks of age.
PATIENTS/METHODS


Infants (n = 24) wore sleep actigraphs for three, one-week periods at 6, 15, and 24 weeks of age. Nighttime TST, sleep efficiency, sleep onset and offset were quantified. Mothers reported on infant bedtime routines using the Brief Infant Sleep Questionnaire at each age. Multilevel models examined between- and within-person associations.
RESULTS


As infants aged, sleep onset was earlier, and bedtime routines became shorter (p's < 0.05). Infants fell asleep between 7 and 8:00PM on 24% of the nights. Most mothers (70%) reported that they often fed infants to sleep for the night. For every 1 h earlier in infants' usual sleep onset, nighttime TST was 34.4 min longer that night (p < 0.01). Infants with earlier than usual sleep onset had slightly earlier sleep offset the next morning (8.4 min for every 1 h earlier in onset; p = 0.02). Between-person analyses showed similar patterns. Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
CONCLUSION


Infants who fell asleep earlier also slept longer at night. Keeping infants up later in hopes of them sleeping in longer may be counterproductive.",2020,"Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
",['Infants (n\xa0'],[],"['Nighttime TST, sleep efficiency, sleep onset and offset', 'Time for bed', 'sleep onset, nighttime TST', 'Infants fell asleep', 'nighttime total sleep time (TST) and efficiency', 'sleep actigraphs', 'nighttime sleep duration', 'longer nighttime TST']","[{'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.041887,"Infants with a more consistent bedtime routine and who were not typically fed to sleep at bedtime had longer nighttime TST at 6 weeks, with a trend or no association at later ages.
","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Adams', 'Affiliation': 'Center for Childhood Obesity Research, Penn State University, University Park, PA, United States; Department of Nutritional Sciences, Penn State University, University Park, PA, United States. Electronic address: elizabeth.adams@vcuhealth.org.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, Penn State University, University Park, PA, United States; Department of Nutritional Sciences, Penn State University, University Park, PA, United States. Electronic address: jfs195@psu.edu.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Master', 'Affiliation': 'Department of Biobehavioral Health, Penn State University, University Park, PA, United States. Electronic address: lindsay.master@gmail.com.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': ""Department of Biobehavioral Health, Penn State University, University Park, PA, United States; Division of Sleep Medicine, Harvard Medical School, Boston, MA, United States; Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA, United States. Electronic address: orfeu@psu.edu.""}]",Sleep medicine,['10.1016/j.sleep.2020.07.003']
1896,32861197,"Gut mycobiome and its interaction with diet, gut bacteria and alzheimer's disease markers in subjects with mild cognitive impairment: A pilot study.","BACKGROUND


Recently, we reported that patients with mild cognitive impairment (MCI) harbor specific signature of bacteria in their gut and that a modified Mediterranean ketogenic diet (MMKD) improves Alzheimer's disease (AD) markers in cerebrospinal fluid (CSF) and the signatures of gut bacteria. However, other microbial population such as gut fungi (mycobiome) in relation to MCI/AD pathology, gut bacteria and diet remain unknown.
METHODS


We measure gut mycobiome by sequencing of the fungal rRNA ITS1 gene in 17 older adults (11 MCI; 6 cognitively normal [CN]) in a single-center, randomized, double-blind, crossover pilot study, before and after 6 weeks intervention of MMKD and American Heart Association Diet (AHAD), and determine its correlation with AD markers in CSF and gut bacteria.
FINDINGS


Compared to CN counterparts, patients with MCI have higher proportion of families Sclerotiniaceae, Phaffomyceteceae, Trichocomaceae, Cystofilobasidiaceae, Togniniaceae and genera Botrytis, Kazachstania, Phaeoacremonium and Cladosporium and lower abundance of Meyerozyma. Specific fungal taxa exhibit distinct correlation arrays with AD markers and gut bacteria in subjects with versus without MCI. MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
INTERPRETATION


The study reveals MCI-specific mycobiome signatures and demonstrates that distinct diets modulate the mycobiome in association with AD markers and fungal-bacterial co-regulation networks in patients with MCI. The findings corroborate the notion of considering gut mycobiome as a unique factor that can affect cognitive health/AD by interacting with gut bacteria and diet and facilitate better understanding of the AD and related microbiome, using unique diet or microbiome modulators.",2020,"MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
","['subjects with versus without MCI', 'subjects with mild cognitive impairment', 'patients with mild cognitive impairment (MCI', 'patients with MCI', '17 older adults (11 MCI; 6 cognitively normal [CN']","['Mediterranean ketogenic diet (MMKD', 'MMKD and American Heart Association Diet (AHAD']","['families Sclerotiniaceae, Phaffomyceteceae, Trichocomaceae, Cystofilobasidiaceae, Togniniaceae and genera Botrytis, Kazachstania, Phaeoacremonium and Cladosporium and lower abundance of Meyerozyma']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1002379', 'cui_str': 'Sclerotiniaceae'}, {'cui': 'C1002104', 'cui_str': 'Trichocomaceae'}, {'cui': 'C0006040', 'cui_str': 'Botrytis'}, {'cui': 'C1085204', 'cui_str': 'Kazachstania'}, {'cui': 'C1025333', 'cui_str': 'Phaeoacremonium'}, {'cui': 'C0008886', 'cui_str': 'Cladosporium'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3008845', 'cui_str': 'Meyerozyma'}]",17.0,0.0319494,"MMKD induces broader effect on fungal diversity in subjects with MCI and increases Agaricus and Mrakia while decreasing Saccharomyces and Claviceps with differential response in subjects with or without MCI.
","[{'ForeName': 'Ravinder', 'Initials': 'R', 'LastName': 'Nagpal', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Neth', 'Affiliation': 'Department of Internal Medicine- Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Neurology, Mayo Clinic, Rochester, MN, United States.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Sidharth P', 'Initials': 'SP', 'LastName': 'Mishra', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Department of Internal Medicine- Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States. Electronic address: suzcraft@wakehealth.edu.'}, {'ForeName': 'Hariom', 'Initials': 'H', 'LastName': 'Yadav', 'Affiliation': 'Department of Internal Medicine-Molecular Medicine, Wake Forest School of Medicine, Winston-Salem, NC, United States; Department of Microbiology and Immunology, Wake Forest School of Medicine, Winston-Salem, NC, United States. Electronic address: hyadav@wakehealth.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102950']
1897,32862713,Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.,"Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13],  P =0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08],  P =0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.",2020,"The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13],  P =0.09).","['Uncontrolled Hypertension', '16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months']","['telemonitoring intervention', 'Home Blood Pressure Telemonitoring and Pharmacist Management']","['blood pressure', 'cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up', 'cardiovascular composite end point incidence', 'estimated event costs', 'Intervention costs', 'secondary cardiovascular composite end point incidence', '15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death']","[{'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",16.0,0.0337506,"The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13],  P =0.09).","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Sperl-Hillen', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Bergdall', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA (B.B.G.).'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Nyboer', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Pamala A', 'Initials': 'PA', 'LastName': 'Pawloski', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Trower', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Maciosek', 'Affiliation': 'From the HealthPartners Institute, Minneapolis, MN (K.L.M., S.P.D., J.S.-H., P.J.O., S.E.A., A.R.B., R.A.N., P.A.P., N.K.T., M.V.M.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15492']
1898,32863098,Examining persuasive message type to encourage staying at home during the COVID-19 pandemic and social lockdown: A randomized controlled study in Japan.,"OBJECTIVE


Behavioral change is the only prevention against the COVID-19 pandemic until vaccines become available. This is the first study to examine the most persuasive message type in terms of narrator difference in encouraging people to stay at home during the COVID-19 pandemic and social lockdown.
METHODS


Participants (n = 1,980) were randomly assigned to five intervention messages (from a governor, a public health expert, a physician, a patient, and a resident of an outbreak area) and a control message. Intention to stay at home before and after reading messages was assessed. A one-way ANOVA with Tukey's or Games-Howell test was conducted.
RESULTS


Compared with other messages, the message from a physician significantly increased participants' intention to stay at home in areas with high numbers of people infected (versus a governor, p = .002; an expert, p = .023; a resident, p = .004).
CONCLUSION


The message from a physician-which conveyed the crisis of overwhelmed hospitals and consequent risk of people being unable to receive treatment-increased the intent to stay at home the most.
PRACTICE IMPLICATIONS


Health professionals and media operatives may be able to encourage people to stay at home by disseminating the physicians' messages through media and the internet.",2020,"Compared with other messages, the message from a physician significantly increased participants' intention to stay at home in areas with high numbers of people infected (versus a governor, p = .002; an expert, p = .023; a resident, p = .004).
","['Participants (n\u2009=\u20091,980', 'Japan']","['five intervention messages (from a governor, a public health expert, a physician, a patient, and a resident of an outbreak area) and a control message']",[],"[{'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0347361,"Compared with other messages, the message from a physician significantly increased participants' intention to stay at home in areas with high numbers of people infected (versus a governor, p = .002; an expert, p = .023; a resident, p = .004).
","[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Okuhara', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan. Electronic address: okuhara-ctr@umin.ac.jp.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kiuchi', 'Affiliation': 'Department of Health Communication, School of Public Health, The University of Tokyo, Tokyo, Japan.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.016']
1899,32863981,The Interpersonal Mindfulness Program for Health Care Professionals: a Feasibility Study.,"Objectives


There are a number of mindfulness-based programs (MBPs) that have demonstrated effectiveness for patients and health care professionals. The Interpersonal Mindfulness Program (IMP) is a relatively new MBP, developed to teach those with prior mindfulness training to deepen their mindful presence, empathy and compassion in the interpersonal domain. The aim of the present study was to examine the feasibility of using the IMP with mental health care workers and assessing its effects on levels of mindfulness, self-compassion, empathy, stress and professional quality of life when compared with the control group participants.
Methods


The IMP training consisted of nine weekly 2.5-h sessions and daily home practice (45-60 min). Twenty-five participants (mean age, 51.4 years) with mindfulness experience participated in the training. Twenty-two individuals in the control group (mean age, 47.5 years) were recruited from those who had followed a mindfulness training before. Feasibility of the IMP was assessed in the training participants in six domains. All study participants completed self-report questionnaires before and after the training.
Results


The IMP training was considered highly acceptable and very useful. The training had a significant positive effect on self-compassion, empathy and compassion fatigue, but no effect on mindfulness, stress and compassion satisfaction. Five participants reported some mild adverse reactions.
Conclusions


The IMP training appears feasible for health care professionals and seems to induce some positive effects. A few mild adverse effects were reported. Further research on the effectiveness and possible mechanisms of change of the IMP training in larger samples is needed.",2020,"The training had a significant positive effect on self-compassion, empathy and compassion fatigue, but no effect on mindfulness, stress and compassion satisfaction.","['Twenty-two individuals in the control group (mean age, 47.5\xa0years) were recruited from those who had followed a mindfulness training before', 'Twenty-five participants (mean age, 51.4\xa0years) with mindfulness experience participated in the training', 'training participants in six domains', 'Health Care Professionals']","['IMP training', 'Interpersonal Mindfulness Program', 'Interpersonal Mindfulness Program (IMP']","['self-compassion, empathy and compassion fatigue', 'mindfulness, stress and compassion satisfaction', 'IMP', 'mild adverse reactions', 'levels of mindfulness, self-compassion, empathy, stress and professional quality of life']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0227839,"The training had a significant positive effect on self-compassion, empathy and compassion fatigue, but no effect on mindfulness, stress and compassion satisfaction.","[{'ForeName': 'Agna A', 'Initials': 'AA', 'LastName': 'Bartels-Velthuis', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Hereweg 76, 9725 AG Groningen, the Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van den Brink', 'Affiliation': 'MBCL Training & Therapie, Koelandsdrift 10, 9755 PN Onnen, the Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Koster', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Hereweg 76, 9725 AG Groningen, the Netherlands.'}, {'ForeName': 'H J Rogier', 'Initials': 'HJR', 'LastName': 'Hoenders', 'Affiliation': 'Lentis Psychiatric Institute, Center for Integrative Psychiatry, Hereweg 76, 9725 AG Groningen, the Netherlands.'}]",Mindfulness,['10.1007/s12671-020-01477-5']
1900,32525975,Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemophilia.,"OBJECTIVE


Strength training is recommended for people with hemophilia; however, published data are anecdotal and have methodological limitations. The purpose of this study was to evaluate the safety and effectiveness of progressive moderate-to-vigorous intensity elastic resistance training on physical function and pain in this patient population.
METHODS


A randomized controlled trial was conducted in a university laboratory setting where 20 patients (17 with severe, 1 with moderate, and 2 with mild hemophilia) aged 21 to 53 years received evaluations at baseline and 8-week follow-up. Participants were allocated to intervention (progressive strength training) or control (usual daily activities) groups. The intervention group trained 2 days per week during 8 weeks with elastic resistance. Intensity during the first 2 weeks was a 20-repetition maximum and increased progressively toward 15, 12, and finally 10 repetition maximum. The primary outcome was muscle strength. Secondary outcomes were the Timed ""Up and Go"" Test score, sit-to-stand, range of motion, Haemophilia Joint Health Score, kinesiophobia score, global impression of pain change, general self-rated health status, and desire to exercise.
RESULTS


The intervention group showed greater strength improvements than the control group in almost all of the joints, with moderate to high effect sizes. The intervention group also showed better Timed ""Up and Go"" and sit-to-stand scores than the control group (moderate effect size), greater range of motion at the knee flexion with the right leg (trivial effect size), and better Haemophilia Joint Health Score at the left knee (small effect size). The intervention group showed greater overall pain reduction, self-rated overall status, and desire to exercise than the control group.
CONCLUSIONS


Progressive strength training with elastic resistance performed twice a week during 8 weeks is safe and effective in people with hemophilia to improve muscle strength and functional capacity, reduce general pain, and improve self-rated health status and desire to exercise.
IMPACT


This study provides evidence for the use of a specific strength training regimen for people with hemophilia.
LAY SUMMARY


People with hemophilia of differing levels of severity, with adequate coverage with clotting factor, can safely engage in progressive strength training and can improve their functioning.",2020,"The intervention group also showed better Timed ""Up and Go"" and sit-to-stand scores than the control group (moderate effect size), greater range of motion at the knee flexion with the right leg (trivial effect size), and better Haemophilia Joint Health Score at the left knee (small effect size).","['People With Hemophilia', '20 patients (17 with severe, 1 with moderate, and 2 with mild hemophilia) aged 21 to 53\xa0years received evaluations at baseline and 8-week follow-up', 'people with hemophilia']","['specific strength training regimen', 'Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training', 'intervention (progressive strength training) or control (usual daily activities', 'progressive moderate-to-vigorous intensity elastic resistance training']","['muscle strength', 'overall pain reduction, self-rated overall status, and desire to exercise', 'Timed ""Up and Go"" Test score, sit-to-stand, range of motion, Haemophilia Joint Health Score, kinesiophobia score, global impression of pain change, general self-rated health status, and desire to exercise', 'Physical Function and Pain', 'Haemophilia Joint Health Score', 'physical function and pain', 'strength improvements', 'Timed ""Up and Go"" and sit-to-stand scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.076451,"The intervention group also showed better Timed ""Up and Go"" and sit-to-stand scores than the control group (moderate effect size), greater range of motion at the knee flexion with the right leg (trivial effect size), and better Haemophilia Joint Health Score at the left knee (small effect size).","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Department of Physiotherapy, Exercise Intervention for Health Research Group, University of Valencia, Valencia, Spain; and National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Pérez-Alenda', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion, University of Valencia, Gascó Oliag 5, Valencia CP 46100 Spain; and Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Carrasco', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion and Intelligent Data Analysis Laboratory, University of Valencia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cruz-Montecinos', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion, University of Valencia and Department of Physical Therapy, Faculty of Medicine, Laboratory of Clinical Biomechanics, University of Chile, Santiago, Chile.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment and Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Bonanad', 'Affiliation': 'Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Querol', 'Affiliation': 'Department of Physiotherapy, Multispeciality Research Group, Physiotherapy in Motion, University of Valencia and Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Megías-Vericat', 'Affiliation': 'Haemostasis and Thrombosis Unit, University and Polytechnic Hospital La Fe and Pharmacy Department, Drug Clinical Area, University and Polytechnic Hospital La Fe.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Department of Physiotherapy, Exercise Intervention for Health Research Group, University of Valencia.'}]",Physical therapy,['10.1093/ptj/pzaa106']
1901,32868152,Treatment With Angiotensin II Is Associated With Rapid Blood Pressure Response and Vasopressor Sparing in Patients With Vasoplegia After Cardiac Surgery: A Post-Hoc Analysis of Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) Study.,"OBJECTIVE


The present study investigated outcomes in patients with vasoplegia after cardiac surgery treated with angiotensin II plus standard-of-care vasopressors. Vasoplegia is a common complication in cardiac surgery with cardiopulmonary bypass and is associated with significant morbidity and mortality. Approximately 250,000 cardiac surgeries with cardiopulmonary bypass are performed in the United States annually, with vasoplegia occurring in 20%to-27% of patients.
DESIGN


Post-hoc analysis of the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) study.
SETTING


Multicenter, multinational study.
PARTICIPANTS


Sixteen patients with vasoplegia after cardiac surgery with cardiopulmonary bypass were enrolled.
INTERVENTIONS


Angiotensin II plus standard-of-care vasopressors (n = 9) compared with placebo plus standard-of-care vasopressors (n = 7).
MEASUREMENTS AND MAIN RESULTS


The primary endpoint was mean arterial pressure response (mean arterial pressure ≥75 mmHg or an increase from baseline of ≥10 mmHg at hour 3 without an increase in the dose of standard-of-care vasopressors). Vasopressor sparing and safety also were assessed. Mean arterial pressure response was achieved in 8 (88.9%) patients in the angiotensin II group compared with 0 (0%) patients in the placebo group (p = 0.0021). At hour 12, the median standard-of-care vasopressor dose had decreased from baseline by 76.5% in the angiotensin II group compared with an increase of 7.8% in the placebo group (p = 0.0013). No venous or arterial thrombotic events were reported.
CONCLUSION


Patients with vasoplegia after cardiac surgery with cardiopulmonary bypass rapidly responded to angiotensin II, permitting significant vasopressor sparing.",2020,Mean arterial pressure response was achieved in 8 (88.9%) patients in the angiotensin II group compared with 0 (0%) patients in the placebo group (p = 0.0021).,"['Patients with vasoplegia after cardiac surgery with cardiopulmonary bypass', 'Sixteen patients with vasoplegia after cardiac surgery with cardiopulmonary bypass were enrolled', 'patients with vasoplegia after cardiac surgery treated with', 'Patients With Vasoplegia']","['Angiotensin', 'placebo plus standard-of-care vasopressors', 'Angiotensin II plus standard-of-care vasopressors', 'placebo', 'angiotensin', 'angiotensin II plus standard-of-care vasopressors']","['No venous or arterial thrombotic events', 'Mean arterial pressure response', 'Vasopressor sparing and safety', 'median standard-of-care vasopressor dose', 'mean arterial pressure response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2717957', 'cui_str': 'Vasoplegia'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}]","[{'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",16.0,0.157746,Mean arterial pressure response was achieved in 8 (88.9%) patients in the angiotensin II group compared with 0 (0%) patients in the placebo group (p = 0.0021).,"[{'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Klijian', 'Affiliation': 'Department of Cardiothoracic Surgery, Sharp and Scripps Healthcare, San Diego, CA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC; Outcomes Research Consortium, Cleveland, OH.'}, {'ForeName': 'V Seenu', 'Initials': 'VS', 'LastName': 'Reddy', 'Affiliation': 'TriStar Cardiovascular Surgery, Nashville, TN.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Friedman', 'Affiliation': ""JM Still Burn Center, Doctor's Hospital, Augusta, GA.""}, {'ForeName': 'Jamel', 'Initials': 'J', 'LastName': 'Ortoleva', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Evans', 'Affiliation': 'ASE Consulting, LLC, Tenafly, NJ.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'John Hunter Hospital, Newcastle, Australia; School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Stew', 'Initials': 'S', 'LastName': 'Kroll', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, CA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Greenfeld', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, CA.'}, {'ForeName': 'Subhasis', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'Divisions of General and Cardiothoracic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Department of Cardiovascular Surgery, Texas Heart Institute, Houston, TX. Electronic address: Subhasis.Chatterjee@bcm.edu.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.001']
1902,32868637,"A randomized, double-blind, dose-ranging, pilot trial of piperine with resveratrol on the effects on serum levels of resveratrol.","Resveratrol (3,4,5-trihydroxystilbene) is a naturally occurring phytoalexin with purported health-promoting effects, but with limited oral bioavailability. Our prior murine modeling research observed enhanced resveratrol bioavailability with piperine co-administration. In this study, single-dose pharmacokinetics of resveratrol with or without piperine and the associated toxicities were studied on a cohort of healthy volunteers. We performed a double-blind, randomized, three-arm pilot study. Participants were randomized to receive a single dose of resveratrol 2.5 g, with piperine in 0 mg, 5 mg, or 25 mg dose. An improved liquid chromatography/mass spectrometry assay was used to determine serum levels of resveratrol and resveratrol-glucuronide. Baseline through 24 h post-study drug serum analyses were performed and adverse events were followed for 30 days. Twenty-four participants were enroled. No significant relationship between dose and pharmacokinetic values were found. In the sex stratified analysis, Cmax for resveratrol in women showed a trend (P = 0.057) toward an increase with piperine. Pharmacokinetic values for resveratrol were: Cmax - 18.5 ± 16 ng/mL resveratrol alone, 29 ± 29 resveratrol + 5 mg piperine, 16 ± 13 resveratrol + 25 mg piperine; area under the concentration × time curve - 1270 ± 852 ng/h/mL resveratrol alone, 2083 ± 2284 resveratrol + 5 mg piperine, 1132 ± 222 resveratrol + 25 mg piperine. All subjects tolerated their protocol therapy with minimal to no toxicity and no evidence of differences between the three groups. The co-administration of resveratrol with piperine at 5 and 25 mg doses did not sufficiently alter the pharmacokinetics of resveratrol or resveratrol-glucuronide to demonstrate the significant enhancement observed in murine modeling.",2020,"Pharmacokinetic values for resveratrol were: Cmax - 18.5 ± 16 ng/mL resveratrol alone, 29 ± 29 resveratrol + 5 mg piperine, 16 ± 13 resveratrol + 25 mg piperine; area under the concentration × time curve - 1270 ± 852 ng/h/mL resveratrol alone, 2083 ± 2284 resveratrol + 5 mg piperine, 1132 ± 222 resveratrol + 25 mg piperine.","['Twenty-four participants were enroled', 'healthy volunteers']","['resveratrol with or without piperine', '2284 resveratrol + 5 mg piperine, 1132 ± 222 resveratrol + 25 mg piperine', 'Resveratrol (3,4,5-trihydroxystilbene', 'resveratrol 2.5 g, with piperine']","['resveratrol bioavailability', 'serum levels of resveratrol', 'toxicities']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0071112', 'cui_str': 'piperine'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",24.0,0.161899,"Pharmacokinetic values for resveratrol were: Cmax - 18.5 ± 16 ng/mL resveratrol alone, 29 ± 29 resveratrol + 5 mg piperine, 16 ± 13 resveratrol + 25 mg piperine; area under the concentration × time curve - 1270 ± 852 ng/h/mL resveratrol alone, 2083 ± 2284 resveratrol + 5 mg piperine, 1132 ± 222 resveratrol + 25 mg piperine.","[{'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Bailey', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Johnson', 'Affiliation': 'Analytical Instrumentation Center, University of Wisconsin, School of Pharmacy, Madison, Wisconsin.'}, {'ForeName': 'Taja', 'Initials': 'T', 'LastName': 'Lozar', 'Affiliation': 'Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Cameron O', 'Initials': 'CO', 'LastName': 'Scarlett', 'Affiliation': 'Analytical Instrumentation Center, University of Wisconsin, School of Pharmacy, Madison, Wisconsin.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'Wollmer', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Havinghurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Ahmad', 'Affiliation': 'Department of Dermatology, University of Wisconsin, Madison, Wisconsin, USA.'}]",European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP),['10.1097/CEJ.0000000000000621']
1903,32869680,Efficacy and safety of tretinoin 0.05% cream to prevent hyperpigmentation during narrowband UV-B phototherapy in patients with facial vitiligo: a randomized clinical trial.,"BACKGROUND


Narrowband UV-B (NBUVB) phototherapy is the mainstay of vitiligo treatment, but hyperpigmentation is one of the limitations. Meanwhile, topical tretinoin is effective against pigmentary disorders.
OBJECTIVE


To determine whether tretinoin 0.05% cream would prevent hyperpigmentation when patients with facial vitiligo underwent phototherapy.
METHODS


A randomized, controlled, split-face trial was conducted. Adult patients with stable, non-segmental facial vitiligo were enrolled. The left/right sides of the face were randomly allocated to receive either topical tretinoin 0.05% cream or moisturizer twice daily. The entire face was subjected to NBUVB phototherapy twice weekly for 12 weeks. The degree of hyperpigmentation was assessed as the delta L* (brightness) value of the darkest spot in each side of the face at baseline and every 4 weeks. The degree of repigmentation was assessed.
RESULTS


Twenty-five patients were enrolled; 21 completed the study. The delta L* value was significantly different between the two groups: -0.5% in the tretinoin group and -8.7% in the control group at 12 weeks ( p  = .002). Marked repigmentation was achieved in 15 patients of both groups.
CONCLUSIONS


Tretinoin 0.05% cream prevented hyperpigmentation during NBUVB phototherapy in patients with facial vitiligo, and did not compromise the overall treatment response.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03933774.",2020,The delta L* value was significantly different between the two groups: -0.5% in the tretinoin group and -8.7% in the control group at 12 weeks ( p  = 0.002).,"['patients with facial vitiligo', 'Twenty-five patients were enrolled; 21 completed the study', 'Adult patients with stable, non-segmental facial vitiligo were enrolled']","['Meanwhile, topical tretinoin', 'Tretinoin', 'tretinoin', 'phototherapy', 'tretinoin 0.05% cream', 'topical tretinoin 0.05% cream or moisturizer twice daily', 'narrowband UV-B phototherapy', 'Narrowband UV-B (NBUVB']","['delta L* value', 'hyperpigmentation', 'Efficacy and safety', 'degree of hyperpigmentation', 'Marked repigmentation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}]","[{'cui': 'C3212626', 'cui_str': 'Tretinoin-containing product in cutaneous dose form'}, {'cui': 'C0040845', 'cui_str': 'Tretinoin'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",25.0,0.146514,The delta L* value was significantly different between the two groups: -0.5% in the tretinoin group and -8.7% in the control group at 12 weeks ( p  = 0.002).,"[{'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': ""Department of Dermatology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Soo Hyung', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': ""Department of Dermatology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Ji Hae', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ""Department of Dermatology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Gyong Moon', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': ""Department of Dermatology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': ""Department of Dermatology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1817298']
1904,32869895,Optimization of the surveillance strategy in patients with colorectal adenomas: A combination of clinical parameters and index colonoscopy findings.,"BACKGROUND AND AIM


In addition to index colonoscopy findings, demographic parameters including age are associated with the risk of metachronous advanced colorectal neoplasia. Here, we aimed to develop a risk scoring model for predicting advanced colorectal neoplasia (ACRN) during surveillance using a combination of clinical factors and index colonoscopy findings.
METHODS


Patients who underwent the removal of one or more adenomas and surveillance colonoscopy were included. A risk scoring model for ACRN was developed using the Cox proportional hazard model. Surveillance interval was determined as a time point exceeding 4% of the cumulative ACRN incidence in each risk group.
RESULTS


Of 9591 participants, 4725 and 4866 were randomly allocated to the derivation and validation cohorts, respectively. Age, abdominal obesity, advanced adenoma, and ≥ 3 adenomas at index colonoscopy were identified as risk factors for metachronous ACRN. Based on the regression coefficients, point scores were assigned as follows: age, 1 point (per 1 year); abdominal obesity, 10 points; advanced adenoma, 10 points; and ≥ 3 adenomas, 15 points. Patients were classified into high-risk (≥ 80 points), moderate-risk (50-79 points), and low-risk (30-49 points) groups. In the validation cohort, the high-risk and moderate-risk groups showed a higher risk of ACRN than the low-risk group (hazard ratio [95% confidence interval]: 7.11 [4.10-12.32] and 1.58 [1.09-2.30], respectively). Two-, 4-, and 5-year surveillance intervals were recommended for the high-risk, moderate-risk, and low-risk groups, respectively.
CONCLUSIONS


Our proposed model may facilitate effective risk stratification of ACRN during surveillance and the determination of appropriate surveillance intervals.",2020,"In the validation cohort, the high- and moderate-risk groups showed a higher risk of ACRN than the low-risk group (hazard ratio [95% confidence interval]: 7.11 [4.10-12.32] and 1.58 [1.09-2.30], respectively).","['Patients who underwent the removal of one or more adenomas and surveillance colonoscopy were included', 'patients with colorectal adenomas', 'Patients were classified into high- (≥80 points), moderate- (50-79 points), and low-risk (30-49 points) groups', 'Of 9,591 participants, 4,725 and 4,866']",[],"['Surveillance interval', 'risk of ACRN', '5-year surveillance intervals']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439234', 'cui_str': 'year'}]",9591.0,0.0643662,"In the validation cohort, the high- and moderate-risk groups showed a higher risk of ACRN than the low-risk group (hazard ratio [95% confidence interval]: 7.11 [4.10-12.32] and 1.58 [1.09-2.30], respectively).","[{'ForeName': 'Chan Hyuk', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.'}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Nam Hee', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Il', 'Initials': 'DI', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Chong Il', 'Initials': 'CI', 'LastName': 'Sohn', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15237']
1905,32871473,Sirolimus versus cyclosporine for the treatment of pediatric chronic immune thrombocytopenia: A randomized blinded trial.,"INTRODUCTION


Chronic immune thrombocytopenia (ITP) of childhood is still a problem. For treating ITP, several immunosuppressive medications can be considered with various response rates. Our goal was to compare effects of sirolimus and cyclosporine on children with chronic ITP.
METHODS


This randomized and blinded trial was carried out on 67 children over 5 years old with chronic ITP. Patients were assigned 1:1 to cyclosporine and sirolimus for 6 months. Platelet count was assessed and compared between 2 study groups at different intervals. The clinical trial registry number was IRCT20180501039499N1.
RESULTS


Sixty-one children completed the 6-month treatment. Mean age was 9.3 years with an excess of females. Compared to baseline values, both drugs caused a significant increase in number of platelets over the course of treatment; sirolimus group: 15,800/mcL vs 96,566/mcL, (P < 0.001), cyclosporine group: 14,400/mcL vs 111,266/mcL, P < 0.001,). In addition, differences of platelet number were statistically significant at some treatment intervals (3rd and 6th month, P < 0.05). A quicker response was observed in children receiving cyclosporine. Both drugs had similar rate of response which occurred in 50% of included patients. Finally, sirolimus had a better safety profile.
CONCLUSIONS


Our study showed that cyclosporine and sirolimus had an equal rate of response in treating chronic ITP of children. At the same time, the two medications showed significant differences in their side effects.",2020,"Compared to baseline values, both drugs caused a significant increase in number of platelets over the course of treatment; sirolimus group: 15,800/mcL vs 96,566/mcL, (P < 0.001), cyclosporine group: 14,400/mcL vs 111,266/mcL, P < 0.001,).","['67 children over 5\xa0years old with chronic ITP', 'pediatric chronic immune thrombocytopenia', 'children with chronic ITP', 'Mean age was 9.3\xa0years with an excess of females']","['sirolimus and cyclosporine', 'cyclosporine and sirolimus', 'sirolimus', 'cyclosporine', 'Sirolimus versus cyclosporine']","['platelet number', 'number of platelets', 'safety profile', 'side effects', 'Platelet count']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",67.0,0.0888878,"Compared to baseline values, both drugs caused a significant increase in number of platelets over the course of treatment; sirolimus group: 15,800/mcL vs 96,566/mcL, (P < 0.001), cyclosporine group: 14,400/mcL vs 111,266/mcL, P < 0.001,).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Mousavi-Hasanzadeh', 'Affiliation': 'Student Research Committee, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Bahador', 'Initials': 'B', 'LastName': 'Bagheri', 'Affiliation': 'Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran; Department of Pharmacology, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Mehrabi', 'Affiliation': 'Student Research Committee, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Aygin', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Students Research Committee, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Ali Asghar Clinical Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: eghbali.a@iums.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106895']
1906,32872033,The efficacy and safety of the infiltration of the interspace between the popliteal artery and the capsule of the knee block in total knee arthroplasty: A prospective randomized trial protocol.,"BACKGROUND


Total knee arthroplasty (TKA) is an established and successful surgical procedure which is the major treatment for degenerative knee joint diseases. A novel technique to address posterior knee joint pain is the infiltration of local anesthetic between the interspace between the popliteal artery and capsule of the knee (IPACK). The goal of this randomized clinical trial was to assess the efficacy and safety of adding IPACK to adductor canal block (ACB) after TKA.
METHODS


This was a prospectively randomized trial that investigated the effectiveness and safety of the IPACK after TKA. Approval from Clinical Studies Ethical Committee in Qilu Hospital of Shandong University was obtained. The inclusion criteria were adult patients undergoing primary unilateral TKA and American Society of Anesthesiologists grade 1 or 2 with normal cognitive function. The patients were randomized to 1 of 2 treatment options: ACB-alone group and ACB + IPACK group. The primary outcome was the total morphine consumption during postoperative 24 hours. Secondary outcomes included postoperative pain score, time to first and total dosage of rescue morphine in postoperative 48 hours, early and late postoperative period (from postoperative day 0-3 months follow-up) performance-based test (Timed-Up and Go test, and quadriceps strength). Postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and other adverse events were also evaluated.
RESULTS


It was hypothesized that when combined with a control group, the IPACK block would result in a lower morphine consumption and pain score after TKA.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5765).",2020,"It was hypothesized that when combined with a control group, the IPACK block would result in a lower morphine consumption and pain score after TKA.
","['adult patients undergoing primary unilateral TKA and American Society of Anesthesiologists grade 1 or 2 with normal cognitive function', 'total knee arthroplasty']","['ACB-alone group and ACB\u200a+\u200aIPACK group', 'Total knee arthroplasty (TKA', 'IPACK']","['total morphine consumption', 'postoperative pain score, time to first and total dosage of rescue morphine in postoperative 48\u200ahours, early and late postoperative period (from postoperative day 0-3 months follow-up) performance-based test (Timed-Up and Go test, and quadriceps strength', 'efficacy and safety', 'effectiveness and safety', 'Postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and other adverse events', 'morphine consumption and pain score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.175673,"It was hypothesized that when combined with a control group, the IPACK block would result in a lower morphine consumption and pain score after TKA.
","[{'ForeName': 'Zhongxiao', 'Initials': 'Z', 'LastName': 'Cong', 'Affiliation': 'Department of Operating Room, Qilu Hospital of Shandong University, Shandong, China.'}, {'ForeName': 'Lejun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Fengying', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021670']
1907,32873667,Randomised cross-over trial of vildagliptin and pioglitazone as add-on therapy in patients with type 2 diabetes: predicting Which One is Right Here (WORTH) study protocol.,"INTRODUCTION


There is emerging evidence for stratified glucose-lowering responses to certain oral medications for type 2 diabetes (T2D) by individual characteristics. The objective of this study was to test whether glycaemic response to representative treatments of dipeptidyl peptidase-4 inhibitors (vildagliptin) and thiazolidinediones (pioglitazone) varies according to ethnicity, gender, baseline obesity, triglyceride level or genetic variation.
METHODS


This is a multicentre, two-period, two-treatment, open-label, randomised cross-over trial of vildagliptin and pioglitazone as second-line or third-line therapy in patients with T2D who have suboptimal glycaemic control on metformin and/or sulfonylurea therapy. It is conducted in New Zealand with a target of 300 patients (40% with Māori or Pacific ancestry) eligible if aged ≥18 and ≤80 years, with T2D for more than 1 year, on stable doses of metformin and/or sulfonylurea for at least 3 months, with HbA1c between 59 and 110 mmol/mol inclusive. Participants are assigned to complete 4 months of vildagliptin 50 mg per day or pioglitazone 30 mg per day, followed by 4 months of the other medications in randomly allocated sequences. Participant characteristics, including ethnicity, obesity, lipid profile and candidate genotypes are collected at baseline. Primary outcome variable is on treatment HbA1c. Secondary outcomes include weight change, frequency of side effects and patient preference.
ETHICS AND DISSEMINATION


Ethical approval of the trial has been obtained from the New Zealand Health and Disability Ethics Committee (18/STH/242). The trial commenced in February 2019 and recruitment is expected to be completed by March 2020. Results will be reported in articles submitted to peer-reviewed journals, as well as in presentations at national and international meetings.
TRIAL REGISTRATION NUMBER


ACTRN12618001907235.",2020,"Secondary outcomes include weight change, frequency of side effects and patient preference.
","['patients with type 2 diabetes', '300 patients (40% with Māori or Pacific ancestry) eligible if aged ≥18 and ≤80 years, with T2D for more than 1 year, on stable doses of metformin and/or sulfonylurea for at least 3 months, with HbA1c between 59 and 110 mmol/mol inclusive', 'patients with T2D who have suboptimal glycaemic control on metformin and/or sulfonylurea therapy']","['vildagliptin 50 mg per day or pioglitazone', 'vildagliptin and pioglitazone', 'dipeptidyl peptidase-4 inhibitors (vildagliptin) and thiazolidinediones (pioglitazone']","['weight change, frequency of side effects and patient preference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}]","[{'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}]",,0.196837,"Secondary outcomes include weight change, frequency of side effects and patient preference.
","[{'ForeName': 'Rui Qian', 'Initials': 'RQ', 'LastName': 'Yeu', 'Affiliation': 'Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brandon', 'Affiliation': 'Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Statistics, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Griffiths', 'Affiliation': 'Zoom Pharmacy, Auckland, New Zealand.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Smallman', 'Affiliation': 'Diabetes Foundation Aotearoa, Auckland, New Zealand.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Moffitt', 'Affiliation': 'ProCARE Health Limited, Auckland, New Zealand.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Doherty', 'Affiliation': 'Tongan Health Society, Auckland, New Zealand.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'University of Waikato, Hamilton, New Zealand.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Harré Hindmarsh', 'Affiliation': 'Ngati Porou Hauora, Te Puia Springs, Tairawhiti, New Zealand.'}, {'ForeName': 'Tony R', 'Initials': 'TR', 'LastName': 'Merriman', 'Affiliation': 'School of Medical Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Macaskill-Smith', 'Affiliation': 'Ventures Limited, Hamilton, New Zealand.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Orr-Walker', 'Affiliation': 'Endocrinology and Diabetes Service, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Medicine, The University of Auckland Faculty of Medical and Health Sciences, Auckland, New Zealand r.murphy@auckland.ac.nz.'}]",BMJ open,['10.1136/bmjopen-2019-036518']
1908,32873669,Effects of coenzyme Q10 on endothelial and cardiac function in patients undergoing haemodialysis: study protocol for a pilot randomised controlled trial.,"INTRODUCTION


Endothelial and cardiac dysfunction are highly prevalent and are associated with cardiovascular morbidity and mortality among patients undergoing dialysis. For patients undergoing dialysis, no study has explored the effect of supplementation of coenzyme Q10 (CoQ10) on endothelial function. To our best of knowledge, only two small sample studies focused on the efficacy of supplementation of CoQ10 on cardiac function. However, the effect of CoQ10 supplementation on cardiac function remains uncertain in patients who undergo haemodialysis. The aim of this study is to explore whether CoQ10 supplementation can improve endothelial and cardiac function in patients undergoing haemodialysis.
METHODS AND ANALYSIS


This is a pilot randomised controlled study. Eligible patients undergoing haemodialysis in our haemodialysis centre will be randomly allocated to the CoQ10 and control groups. The follow-up time is 12 months. The primary outcome is to assess the change of brachial artery endothelial-dependent flow-mediated dilation, left ventricular systolic function, diastolic function and Myocardial Performance Index at 12 months from baseline. Secondary outcomes are death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index.
ETHICS AND DISSEMINATION


Risks associated with CoQ10 are minor, even at doses as high as 1800 mg according to previous studies. The trial has received ethics approval from the Medical Ethics Committee for Clinical Trials of Drugs, the 306th Hospital of Chinese PLA. The results of the study are expected to be published in a peer-reviewed journal and presented at academic conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900022258.",2020,"Secondary outcomes are death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index.
","['patients undergoing haemodialysis', 'Eligible patients undergoing haemodialysis in our haemodialysis centre', 'patients who undergo haemodialysis', 'patients undergoing dialysis']","['coenzyme Q10', 'CoQ10 supplementation', 'CoQ10', 'coenzyme Q10 (CoQ10']","['death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index', 'endothelial and cardiac function', 'change of brachial artery endothelial-dependent flow-mediated dilation, left ventricular systolic function, diastolic function and Myocardial Performance Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0050078', 'cui_str': '8-hydroxy-deoxyguanosine'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}]",,0.153416,"Secondary outcomes are death or hospitalisation due to cardiovascular events, all-cause mortality, change of CoQ10 concentration, the ratio of ubiquinol to ubiquinone, the change of oxidative stress markers (including malondialdehyde and 8-hydroxy-deoxyguanosine) and Left Ventricular Mass Index.
","[{'ForeName': 'Yongxing', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Xinlou', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Medical Research, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Ultrasound in Medicine, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Department of Ultrasound in Medicine, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Enhong', 'Initials': 'E', 'LastName': 'Han', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Fugui', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Nephrology, Chinese PLA Strategic Support Force Characteristic Medical Center (The 306th Hospital of Chinese PLA), Beijing, China gao306kidney@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-036732']
1909,32876229,Respuestas rápidas a la pandemia de COVID-19 a través de la ciencia y la colaboración global: el ensayo clínico Solidaridad.,"COVID-19 represents a global crisis. Rapidly conducting a clinical trial with the rigor necessary to obtain reliable results requires the collaboration of various participants involved in the development, evaluation and authorization of clinical trials (CT) such as the trial sponsor, researchers, regulatory authority and the ethics committee (EC). Carrying out these studies is not only scientifically appropriate, but an ethical and moral obligation to guarantee our patients effective treatment. SOLIDARITY is a mega clinical trial that recruited thousands of subjects with moderate to severe disease, who were randomly assigned to one of the treatment groups under evaluation, including hydroxychloroquine, lopinavir/ritonavir associated or not with interferon; or remdesivir compared to standard therapy. Peru has joined the list of countries where the trial will be reproduced, through which it will be possible to quickly identify if any of these drugs offers a real benefit to patients.",2020,"Peru has joined the list of countries where the trial will be reproduced, through which it will be possible to quickly identify if any of these drugs offers a real benefit to patients.",['subjects with moderate to severe disease'],"['hydroxychloroquine, lopinavir/ritonavir associated or not with interferon; or remdesivir compared to standard therapy']",[],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],,0.0535584,"Peru has joined the list of countries where the trial will be reproduced, through which it will be possible to quickly identify if any of these drugs offers a real benefit to patients.","[{'ForeName': 'Alonso', 'Initials': 'A', 'LastName': 'Soto', 'Affiliation': 'Instituto de Investigación en Ciencias Biomédicas, Universidad Ricardo Palma, Lima, Perú.'}, {'ForeName': 'Dante M', 'Initials': 'DM', 'LastName': 'Quiñones-Laveriano', 'Affiliation': 'Instituto de Investigación en Ciencias Biomédicas, Universidad Ricardo Palma, Lima, Perú.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Garcia', 'Affiliation': 'Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Perú.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Henao-Restrepo', 'Affiliation': 'Organización Mundial de la Salud, Ginebra, Suiza.'}]",Revista peruana de medicina experimental y salud publica,['10.17843/rpmesp.2020.372.5546']
1910,32871554,Enhanced Cycling Time-Trial Performance During Multiday Exercise With Higher-Pressure Compression Garment Wear.,"PURPOSE


Compression garments are widely used as a tool to accelerate recovery from intense exercise and have also gained traction as a performance aid, particularly during periods of limited recovery. This study tested the hypothesis that increased pressure levels applied via high-pressure compression garments would enhance ""multiday"" exercise performance.
METHODS


A single-blind crossover design, incorporating 3 experimental conditions-loose-fitting gym attire (CON), low-compression (LC), and high-compression (HC) garments-was adopted. A total of 10 trained male cyclists reported to the laboratory on 6 occasions, collated into 3 blocks of 2 consecutive visits. Each ""block"" consisted of 3 parts, an initial high-intensity protocol, a 24-hour period of controlled rest while wearing the applied condition/garment (CON, LC, and HC), and a subsequent 8-km cycling time trial, while wearing the respective garment. Subjective discomfort questionnaires and blood pressure were assessed prior to each exercise bout. Power output, oxygen consumption, and heart rate were continuously measured throughout exercise, with plasma lactate, creatine kinase, and myoglobin concentrations assessed at baseline and the end of exercise, as well as 30 and 60 minutes postexercise.
RESULTS


Time-trial performance was significantly improved during HC compared with both CON and LC (HC = 277 [83], CON = 266 [89], and LC = 265 [77] W; P < .05). In addition, plasma lactate was significantly lower at 30 and 60 minutes postexercise on day 1 in HC compared with CON. No significant differences were observed for oxygen consumption, heart rate, creatine kinase, or subjective markers of discomfort.
CONCLUSION


The pressure levels exerted via lower-limb compression garments influence their effectiveness for cycling performance, particularly in the face of limited recovery.",2020,"RESULTS


Time-trial performance was significantly improved during HC compared with both CON and LC (HC = 277 [83], CON = 266 [89], and LC = 265",['10 trained male cyclists'],"['Multiday Exercise With Higher-Pressure Compression Garment Wear', 'CON and LC', '3 experimental conditions-loose-fitting gym attire (CON), low-compression (LC), and high-compression (HC) garments']","['Time-trial performance', 'Power output, oxygen consumption, and heart rate', 'Subjective discomfort questionnaires and blood pressure', 'plasma lactate', 'plasma lactate, creatine kinase, and myoglobin concentrations', 'oxygen consumption, heart rate, creatine kinase, or subjective markers of discomfort']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0009072', 'cui_str': 'Garments'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0027078', 'cui_str': 'Myoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",10.0,0.0780208,"RESULTS


Time-trial performance was significantly improved during HC compared with both CON and LC (HC = 277 [83], CON = 266 [89], and LC = 265","[{'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McKendry', 'Affiliation': ''}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Breen', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0716']
1911,32871556,Effect of High-Intensity Interval Training Versus Small-Sided Games Training on Sleep and Salivary Cortisol Level.,"PURPOSE


The authors compared sleep quality and salivary cortisol concentration after high-intensity interval training (HIIT) and small-sided games (SSGs) performed at the habitual training time in nonprofessional male soccer players.
METHODS


A total of 32 players (age = 24 [6] y, height = 1.77 [0.06] m, and body mass = 75 [12] kg) were randomized into an HIIT group or an SSG group. Actual sleep time, sleep efficiency (SE), sleep latency, immobility time (IT), moving time (MT), and fragmentation index were monitored using actigraphy before (PRE) and 2 nights after (POST 1 and POST 2) the training session. Salivary cortisol levels were measured before (PRE) and after (POST) training. Cortisol awakening response was evaluated.
RESULTS


Significant intragroup differences in the HIIT group were noted for actual sleep time (P < .0001), SE (P < .0001), sleep latency (P = .047), IT (P < .0001), MT (P < .0001), and fragmentation index (P < .0001) between PRE and POST 1 and for SE (P = .035), IT (P = .004), MT (P = .006), and fragmentation index (P = .048) between PRE and POST 2. Intergroup differences for actual sleep time (P = .014), SE (P = .048), IT (P < .0001), and MT (P = .046) were observed between the HIIT and the SSGs group at POST 1 were detected. Significant intragroup variations were observed in PRE and POST salivary cortisol levels (P < .0001 for HIIT; P = .0003 for SSGs) and cortisol awakening response (P < .0001 for HIIT; P < .0001 for SSGs). Significant intergroup differences between the HIIT and the SSGs group were found at POST (P < .0001) and in cortisol awakening response (P = .017).
CONCLUSIONS


Changes in actigraphy-based sleep parameters and salivary cortisol levels were greater after an acute session of HIIT than SSGs in this sample of nonprofessional male soccer players.",2020,"RESULTS


Significant intragroup differences in the HIIT group were noted for actual sleep time (P < .0001), SE (P < .0001), sleep latency (P = .047), IT (P < .0001), MT (P < .0001), and fragmentation index (P < .0001) between PRE and POST 1 and for SE (P = .035)","['32 players (age = 24 [6', 'nonprofessional male soccer players']","['High-Intensity Interval Training Versus Small-Sided Games Training', 'SSG', 'high-intensity interval training (HIIT) and small-sided games (SSGs']","['Actual sleep time, sleep efficiency (SE), sleep latency, immobility time (IT), moving time (MT), and fragmentation index', 'cortisol awakening response', 'SE', 'sleep quality and salivary cortisol concentration', 'salivary cortisol levels', 'Salivary cortisol levels', 'Cortisol awakening response', 'sleep latency', 'PRE and POST salivary cortisol levels', 'actual sleep time', 'fragmentation index', 'Sleep and Salivary Cortisol Level']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0231441', 'cui_str': 'Immobile'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.034567,"RESULTS


Significant intragroup differences in the HIIT group were noted for actual sleep time (P < .0001), SE (P < .0001), sleep latency (P = .047), IT (P < .0001), MT (P < .0001), and fragmentation index (P < .0001) between PRE and POST 1 and for SE (P = .035)","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonato', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': ''}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Saresella', 'Affiliation': ''}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Marventano', 'Affiliation': ''}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Merati', 'Affiliation': ''}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Banfi', 'Affiliation': ''}, {'ForeName': 'Jacopo A', 'Initials': 'JA', 'LastName': 'Vitale', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0498']
1912,32871557,Postexercise Hot-Water Immersion Does Not Further Enhance Heat Adaptation or Performance in Endurance Athletes Training in a Hot Environment.,"PURPOSE


Hot-water immersion (HWI) after training in temperate conditions has been shown to induce thermophysiological adaptations and improve endurance performance in the heat; however, the potential additive effects of HWI and training in hot outdoor conditions remain unknown. Therefore, this study aimed to determine the effect of repeated postexercise HWI in athletes training in a hot environment.
METHODS


A total of 13 (9 female) elite/preelite racewalkers completed a 15-day training program in outdoor heat (mean afternoon high temperature = 34.6°C). Athletes were divided into 2 matched groups that completed either HWI (40°C for 30-40 min) or seated rest in 21°C (CON), following 8 training sessions. Pre-post testing included a 30-minute fixed-intensity walk in heat, laboratory incremental walk to exhaustion, and 10,000-m outdoor time trial.
RESULTS


Training frequency and volume were similar between groups (P = .54). Core temperature was significantly higher during immersion in HWI (38.5 [0.3]) than CON (37.8°C [0.2°C]; P < .001). There were no differences between groups in resting or exercise rectal temperature or heart rate, skin temperature, sweat rate, or the speed at lactate threshold 2, maximal O2 uptake, or 10,000-m performance (P > .05). There were significant (P < .05) pre-post differences for both groups in submaximal exercising heart rate (∼11 beats·min-1), sweat rate (0.34-0.55 L·h-1) and thermal comfort (1.2-1.5 arbitrary units), and 10,000-m racewalking performance time (∼3 min).
CONCLUSIONS


Both groups demonstrated significant improvement in markers of heat adaptation and performance; however, the addition of HWI did not provide further enhancements. Improvements in adaptation appeared to be maximized by the training program in hot conditions.",2020,"There were no differences between groups in resting or exercise rectal temperature or heart rate, skin temperature, sweat rate, or the speed at lactate threshold 2, maximal O2 uptake, or 10,000-m performance (P > .05).","['Endurance Athletes Training in a Hot Environment', 'A total of 13 (9 female) elite/preelite racewalkers completed a 15-day training program in outdoor heat (mean afternoon high temperature = 34.6°C', 'athletes training in a hot environment']","['HWI (40°C for 30-40\xa0min) or seated rest in 21°C (CON', 'repeated postexercise HWI', 'Postexercise Hot-Water Immersion']","['markers of heat adaptation and performance', 'submaximal exercising heart rate (∼11\xa0beats·min-1), sweat rate', 'Core temperature', 'Heat Adaptation or Performance', 'thermal comfort', 'resting or exercise rectal temperature or heart rate, skin temperature, sweat rate, or the speed at lactate threshold 2, maximal O2 uptake, or 10,000-m performance']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0241922', 'cui_str': 'Hot environment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]","[{'cui': 'C0337023', 'cui_str': 'Hot water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3544386', 'cui_str': 'Heat Tolerance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",,0.0404612,"There were no differences between groups in resting or exercise rectal temperature or heart rate, skin temperature, sweat rate, or the speed at lactate threshold 2, maximal O2 uptake, or 10,000-m performance (P > .05).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Stevens', 'Affiliation': ''}, {'ForeName': 'Megan L R', 'Initials': 'MLR', 'LastName': 'Ross', 'Affiliation': ''}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Carr', 'Affiliation': ''}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Vallance', 'Affiliation': ''}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Best', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Urwin', 'Affiliation': ''}, {'ForeName': 'Julien D', 'Initials': 'JD', 'LastName': 'Périard', 'Affiliation': ''}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Burke', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2020-0114']
1913,32881945,"Effect of complementary feeding behavior change communication delivered through community-level actors on dietary adequacy of infants in rural communities of West Gojjam Zone, Northwest Ethiopia: A cluster-randomized controlled trial.","BACKGROUND


Attaining the recommended level of adequacy of the infant's diet remains a serious challenge in most developing countries. Complementary foods, particularly in developing countries, are inadequate in quality and quantity that can result in adverse health and nutrition consequences in infants. This could be not only because of lack of food but also associated with caregiver's poor knowledge, harmful cultural norms and behaviors on infant feeding. The promotion of optimal complementary feeding through behavior change interventions is a global health priority. However, many of the interventions targeted only mothers/caregivers of infants, and studies that engaged other family members are limited worldwide. Moreover, such interventions are scarce in developing countries, including Ethiopia. This trial aimed to evaluate the effectiveness of complementary feeding behavior change communication delivered through community-level actors on the dietary adequacy of infants.
METHODS


We conducted a cluster-randomized controlled trial in rural communities of West Gojjam Zone, Northwest Ethiopia. Trial participants in the intervention clusters received complementary feeding behavior change communication for 9 months whereas those in the control clusters received only the usual care. Trained women development army leaders delivered the intervention. A pre-tested, structured interviewer-administered questionnaire was used for data collection. Generalized estimating equations regression analyses adjusted for baseline covariates and clustering were used to test the intervention effects.
RESULTS


The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87]. The proportions of infants who achieved minimum dietary diversity [RR = 3; 95% CI: 1.34, 7.39], minimum meal frequency [RR = 2.4; 95% CI: 1.37-4.29], and minimum acceptable diet [RR = 2.7; 95% CI: 1.13-7.23] were significantly higher in the intervention as compared to control groups.
CONCLUSIONS


Complementary feeding behavior change communication delivered through community-level actors significantly improved the dietary adequacy of infants.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03488680. Registered 5 April 2018- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03488680.",2020,"The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87].","['infants\xa0in rural communities of West Gojjam Zone, Northwest Ethiopia', 'rural communities of West Gojjam Zone, Northwest Ethiopia', 'Trained women development army leaders', 'infants']","['complementary feeding behavior change communication', 'complementary feeding behavior change communication delivered through community-level actors']","['consumption of dairy products', 'minimum meal frequency']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0335083', 'cui_str': 'Actor'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0010947', 'cui_str': 'Dairy foods'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.211057,"The intervention showed positive statistically significant effects on the consumption of dairy products [RR = 1.8; 95% CI: 1.04-3.13], eggs [RR = 3; 95% CI: 1.35-6.56], vitamin A-rich fruits and vegetables [RR = 2.7; 95% CI: 1.17-6.1], other fruits and vegetables [RR = 5; 95% CI: 2.49-10.58] and animal-source foods [RR = 2; 95% CI: 1.39-2.87].","[{'ForeName': 'Chalachew', 'Initials': 'C', 'LastName': 'Abiyu', 'Affiliation': 'School of Medicine, College of Medicine and Health Sciences, Wollo University, Dessie, Ethiopia.'}, {'ForeName': 'Tefera', 'Initials': 'T', 'LastName': 'Belachew', 'Affiliation': 'Faculty of Public Health, Department of Nutrition and Dietetics, Jimma University, Jimma, Ethiopia.'}]",PloS one,['10.1371/journal.pone.0238355']
1914,32868370,'Immunity Passports' for SARS-CoV-2: an online experimental study of the impact of antibody test terminology on perceived risk and behaviour.,"OBJECTIVE


To assess the impact of describing an antibody-positive test result using the terms Immunity and Passport or Certificate, alone or in combination, on perceived risk of becoming infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and protective behaviours.
DESIGN


2×3 experimental design.
SETTING


Online.
PARTICIPANTS


1204 adults from a UK research panel.
INTERVENTION


Participants were randomised to receive one of six descriptions of an antibody test and results showing SARS-CoV-2 antibodies, differing in the terms describing the type of test (Immunity vs Antibody) and the test result (Passport vs Certificate vs Test).
MAIN OUTCOME MEASURES


Primary outcome: proportion of participants perceiving no risk of infection with SARS-CoV-2 given an antibody-positive test result. Other outcomes include: intended changes to frequency of hand washing and physical distancing.
RESULTS


When using the term Immunity (vs Antibody), 19.1% of participants (95% CI 16.1% to 22.5%) (vs 9.8% (95% CI 7.5% to 12.4%)) perceived no risk of catching coronavirus given an antibody-positive test result (adjusted OR (AOR): 2.91 (95% CI 1.52 to 5.55)). Using the terms Passport or Certificate-as opposed to Test-had no significant effect (AOR: 1.24 (95% CI 0.62 to 2.48) and AOR: 0.96 (95% CI 0.47 to 1.99) respectively). There was no significant interaction between the effects of the test and result terminology. Across groups, perceiving no risk of infection was associated with an intention to wash hands less frequently (AOR: 2.32 (95% CI 1.25 to 4.28)); there was no significant association with intended avoidance of physical contact (AOR: 1.37 (95% CI 0.93 to 2.03)).
CONCLUSIONS


Using the term Immunity (vs Antibody) to describe antibody tests for SARS-CoV-2 increases the proportion of people believing that an antibody-positive result means they have no risk of catching coronavirus in the future, a perception that may be associated with less frequent hand washing.
TRIAL REGISTRATION NUMBER


Open Science Framework: https://osf.io/tjwz8/files/.",2020,"Using the term Immunity (vs Antibody) to describe antibody tests for SARS-CoV-2 increases the proportion of people believing that an antibody-positive result means they have no risk of catching coronavirus in the future, a perception that may be associated with less frequent hand washing.
",['1204 adults from a UK research panel'],[],"['proportion of participants perceiving no risk of infection with SARS-CoV-2 given an antibody-positive test result', 'frequency of hand washing and physical distancing', 'intended avoidance of physical contact', 'perceiving no risk of infection', 'no risk of catching coronavirus given an antibody-positive test result (adjusted OR (AOR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0221190', 'cui_str': 'Physical contact'}, {'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]",1204.0,0.116759,"Using the term Immunity (vs Antibody) to describe antibody tests for SARS-CoV-2 increases the proportion of people believing that an antibody-positive result means they have no risk of catching coronavirus in the future, a perception that may be associated with less frequent hand washing.
","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': ""School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'G James', 'Initials': 'GJ', 'LastName': 'Rubin', 'Affiliation': ""Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Henry W W', 'Initials': 'HWW', 'LastName': 'Potts', 'Affiliation': 'Centre for Health Informatics and Multiprofessional Education, UCL, London, UK.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Mottershaw', 'Affiliation': 'Behavioural Insights Team, London, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge, UK tm388@cam.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-040448']
1915,32868517,Improving Timeliness of Internal Medicine Consults in the Emergency Department: A Quality Improvement Initiative.,"INTRODUCTION


Emergency department (ED) wait time is an important health system quality indicator. Prolonged consult to decision time (CTDT), the time it takes to reach a disposition decision after receiving a specialty consultation request, can contribute to increased overall length of stay in the ED.
OBJECTIVE


To identify delays in the consultation process for general internal medicine (GIM) and trial interventions to reduce CTDT.
METHODS


The study was conducted at a large tertiary teaching hospital with GIM inpatient wards at two campuses. Four interventions were trialed over sequential Plan-Do-Study-Act cycles: (1) process mapping, (2) resident education sessions, (3) audit and feedback of CTDT, and (4) adding a swing shift during peak consult volume.
MEASUREMENTS


The primary outcome measures were mean CTDT for patients admitted to GIM and the proportion of admitted patients with CTDT of less than 3 hours.
RESULTS


Mean CTDT decreased from 4.61 hours before intervention to 4.18 hours after intervention (p < .0001). The proportion of GIM patients with CTDT less than 3 hours increased from 25% to 33% (p < .0001).
CONCLUSIONS


The interventions trialed led to a sustained reduction in CTDT over a 12-month period and demonstrated the effectiveness of education in influencing physician performance.",2020,"RESULTS


Mean CTDT decreased from 4.61 hours before intervention to 4.18 hours after intervention (p < .0001).","['large tertiary teaching hospital with GIM inpatient wards at two campuses', 'Emergency Department']",[],"['Mean CTDT', 'mean CTDT']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0233374,"RESULTS


Mean CTDT decreased from 4.61 hours before intervention to 4.18 hours after intervention (p < .0001).","[{'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Beckerleg', 'Affiliation': ''}, {'ForeName': 'Delvina', 'Initials': 'D', 'LastName': 'Hasimja-Saraqini', 'Affiliation': ''}, {'ForeName': 'Edmund S H', 'Initials': 'ESH', 'LastName': 'Kwok', 'Affiliation': ''}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Hamdy', 'Affiliation': ''}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Battram', 'Affiliation': ''}, {'ForeName': 'Krista R', 'Initials': 'KR', 'LastName': 'Wooller', 'Affiliation': ''}]",Journal for healthcare quality : official publication of the National Association for Healthcare Quality,['10.1097/JHQ.0000000000000235']
1916,32868698,"Effects of Localized Heating on Pain, Skin Perfusion, and Wound Healing After Lumbar Decompression.","BACKGROUND


Current evidence regarding the effectiveness and safety of localized heating after spinal surgery for pain, peripheral tissue perfusion, and wound healing is conflicting.
METHODS


This study was a prospective, single-blind, randomized controlled trial; 58 adult patients were randomized to an experimental group or a control group after spinal decompression surgery. All participants received localized cooling on postoperative days 1 and 2. The experimental group received localized heating at the surgical wound on postoperative days 3 and 4, and the control group kept normothermia without localized heating. Outcome variables were evaluated 1 hour after surgery and on day 4.
RESULTS


Postoperative pain was significantly lower in the experimental versus control group (13.8 vs 23.0, P = .01). Skin perfusion was better in the experimental versus control group (4.7 vs 2.8, P = .001). There was no statistically significant difference in the wound healing status between the groups.
CONCLUSION


Localized heating can effectively relieve postoperative pain and improve skin perfusion. These results suggest that localized heating tailored to the wound healing process may be beneficial for patients undergoing spinal surgery.",2020,"Skin perfusion was better in the experimental versus control group (4.7 vs 2.8, P = .001).","['patients undergoing spinal surgery', '58 adult patients']","['control group after spinal decompression surgery', 'localized cooling', 'Localized heating', 'localized heating at the surgical wound on postoperative days 3 and 4, and the control group kept normothermia without localized heating', 'Localized Heating']","['postoperative pain and improve skin perfusion', 'Pain, Skin Perfusion, and Wound Healing', 'Postoperative pain', 'Skin perfusion', 'wound healing status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0408670', 'cui_str': 'Decompression of spinal cord'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1320404', 'cui_str': 'Wound healing status'}]",58.0,0.0640191,"Skin perfusion was better in the experimental versus control group (4.7 vs 2.8, P = .001).","[{'ForeName': 'Jeoung Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Jeoung Hee Kim, MSN RN APN, is a Clinical Nurse Specialist, Asan Medical Center and a Doctoral Student, Hanyang University, Seoul, Korea.'}, {'ForeName': 'Yong Soon', 'Initials': 'YS', 'LastName': 'Shin', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000529']
1917,32866488,Does Concentrated Growth Factor Used With Allografts in Maxillary Sinus Lifting Have Adjunctive Benefits?,"PURPOSE


Recent studies have shown that the use of platelet concentration products alone, or in combination with variable graft materials, accelerates the new bone formation associated with sinus augmentation. The aim of this study was to measure the adjunctive effects of concentrated growth factor (CGF) used with allograft on new bone formation and augmentation stability in sinus lifting.
MATERIALS AND METHODS


This randomized controlled study included patients who presented for dental implant placement in atrophic posterior maxilla at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University, and who needed maxillary sinus augmentation. All patients were treated with a 2-stage surgical technique using sinus lifting bilaterally and implant placement 6 months later. During sinus lifting surgery, one side was grafted with allograft (group 1) and the other side with allograft mixed CGF (group 2). Cone-beam computed tomography was carried out immediately postoperatively and also 6 months after the augmentation to evaluate vertical bone height and percentage of resorption. Bone specimens were obtained at the time of implant placement and evaluated histomorphometrically to analyze the percentage of new bone formation and residual graft particle. Statistical comparisons were conducted between groups for all these measurements.
RESULTS


A total of 10 patients (2 females and 8 males) with a mean age of 57 years (range, 39 to 72) were enrolled in the study. Cone-beam computed tomography analysis revealed a significantly higher percentage of bone height resorption at the sixth month in group 1 (median, 9.32%) compared with group 2 (median, 6.37%) (P < .05). According to the histomorphometric examination, the percentage of new bone formation in group 2 (median, 36.41%) was higher than group 1 (median, 35.49%), but this difference did not reach statistical significance.
CONCLUSIONS


Using CGF with allografts supports the stabilization of gained vertical bone height after sinus augmentation, but further research is needed to determine the accelerating effects of CGF on new bone formation.",2020,"According to the histomorphometric examination, the percentage of new bone formation in group 2 (median, 36.41%) was higher than group 1 (median, 35.49%), but this difference did not reach statistical significance.
","['10 patients (2 females and 8 males) with a mean age of 57\xa0years (range, 39 to 72) were enrolled in the study', 'patients who presented for dental implant placement in atrophic posterior maxilla at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University, and who needed maxillary sinus augmentation']","['concentrated growth factor (CGF', 'Cone-beam computed tomography', 'side with allograft mixed CGF', '2-stage surgical technique using sinus lifting bilaterally and implant placement 6\xa0months later']","['bone height resorption', 'percentage of new bone formation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",10.0,0.0198966,"According to the histomorphometric examination, the percentage of new bone formation in group 2 (median, 36.41%) was higher than group 1 (median, 35.49%), but this difference did not reach statistical significance.
","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Adalı', 'Affiliation': 'Assistant Professor, Department Head, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Izmir Democracy University, Izmir, Turkey. Electronic address: emineadali88@windowslive.com.'}, {'ForeName': 'Meltem Ozden', 'Initials': 'MO', 'LastName': 'Yüce', 'Affiliation': 'Research Assistant, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University, Izmir, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Günbay', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University, Izmir, Turkey.'}, {'ForeName': 'Sevtap', 'Initials': 'S', 'LastName': 'Günbay', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ege University, Izmir, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.217']
1918,32866619,Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans.,"Nuclear factor erythroid-2-related factor 2 (Nrf2), is an inducible transcription factor that improves redox balance through stimulating antioxidant gene expression. In older humans the Nrf2 response to a single bout of acute exercise is blunted compared to young indicating impaired redox signaling. The purpose of this randomized controlled trial was to investigate if the signaling impairment could be reversed with exercise training in older men and women, while also comparing to young. Young (18-28y, n = 21) and older (≥60y, n = 19) men and women were randomized to 8-week aerobic exercise training (ET; 3 d/wk, 45 min/d) or a non-exercise control group (CON). Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein were measured in PBMCs in response to acute exercise trial (AET; 30-min cycling at 70% VO 2  peak pre- and post-intervention at 7 timepoints (Pre, +10 m, +30 m, +1 h, +4 h, +8 h, +24 h). Young had greater Nrf2 signaling response compared to older at pre-intervention (p = 0.05), whereas the older had significantly higher basal Nrf2 levels (p = 0.004). ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05). The degree of restoration in Nrf2 signaling response was related to the degree of change in basal Nrf2 (p = 0.039), which was driven by older adults (p = 0.014). Lower basal nuclear Nrf2 levels were associated with changes seen in AET responses for Nrf2 and GCLC protein, as well as NQO1 and GCLC mRNA. Together these data demonstrate that exercise training improves Nrf2 signaling and downstream gene expression and that lower basal Nrf2 levels are associated with a more dynamic acute response. Our results provide evidence that the impaired Nrf2 signaling in sedentary older adults can be restored to a degree with moderate exercise training, albeit not to the level seen in young. CLINICALTRIALS.GOV ID: NCT03419988.",2020,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"['sedentary older adults', 'older humans', 'older men and women, while also comparing to young', 'Young (18-28y, n\u202f=\u202f21) and older (≥60y, n\u202f=\u202f19) men and women']","['Aerobic exercise training', 'aerobic exercise training (ET; 3\u202fd/wk, 45\u202fmin/d) or a non-exercise control group (CON', 'exercise training', 'CON']","['Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein', 'Nrf2 signaling response', 'basal Nrf2 levels', 'basal Nrf2 expression', 'impairment of Nrf2 activation', 'Nrf2 signaling and downstream gene expression']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1136197', 'cui_str': 'NAD(P)H dehydrogenase (quinone) 1, human'}, {'cui': 'C0018969', 'cui_str': 'Heme oxygenase (decyclizing)'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]",,0.0441431,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"[{'ForeName': 'Ethan L', 'Initials': 'EL', 'LastName': 'Ostrom', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Tinna', 'Initials': 'T', 'LastName': 'Traustadóttir', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA. Electronic address: tinna.traustadottir@nau.edu.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.08.016']
1919,32866688,Improved neck posture and reduced neck muscle activity when using a novel camera based workstation for manual precision inspection tasks.,"PURPOSE


This study investigates the effects of the usage of a novel camera system compared to a conventional lens system for manual precision tasks. Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
METHODS


Camera and lens systems were compared by assessing the craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion. 16 healthy participants (n = 8 female, 24 ± 2 years; n = 8 male, 30 ± 5 years) performed manual precision tasks in a cross-over design using both systems in sitting and standing positions.
RESULTS


Analyses showed that using the camera system improved the CVA in sitting [28.4° (22.8°-33.9°) to 42.5° (38.9°-46.1°); p < 0.01] and decreased the M.trapezius activity in standing [13.1% (7.7%-18.6%) to 8.65% (5.49%-11.81%)]. Additionally, overall and neck specific perceived exertion decreased when using the camera system in standing.
CONCLUSIONS


The camera system may prevent neck pain in workers performing manual precision tasks in sitting and standing postures.",2020,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","['16 healthy participants (n\xa0=\xa08 female, 24\xa0±\xa02 years; n\xa0=\xa08 male, 30\xa0±\xa05 years) performed']","['manual precision tasks in a cross-over design using both systems in sitting and standing positions', 'novel camera system']","['craniovertebral angle (CVA), electromyographic activity of the M.trapezius and perceived exertion', 'CVA in sitting', 'Improved neck posture and reduced neck muscle activity', 'M.trapezius activity', 'overall and neck specific perceived exertion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0179533', 'cui_str': 'Camera'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",16.0,0.0296013,"Utilizing the novel camera system aims to improve neck posture, reduce neck muscle tension and thereby minimize the risk of neck pain.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gräf', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mattes', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Luedtke', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Health Sciences, Academic Physiotherapy, Pain and Exercise Research Luebeck (P.E.R.L), University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Wollesen', 'Affiliation': 'Department of Human Movement Science, University of Hamburg, Mollerstraße 10, 20148, Hamburg, Germany; Department of Psychology and Neuroergonomics, Technical University of Berlin, Fasanenstraße 1, 10623, Berlin, Germany. Electronic address: bettina.wollesen@uni-hamburg.de.'}]",Applied ergonomics,['10.1016/j.apergo.2020.103147']
1920,32868991,Guided Internet-delivered cognitive behaviour therapy for perfectionism in a non-clinical sample of adolescents: A study protocol for a randomised controlled trial.,"Background


Perfectionism is elevated across a range of psychopathologies and has been shown to impede treatment outcomes. There is also evidence suggesting elevated perfectionism may contribute to the onset and maintenance of non-suicidal self-injury. There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up. There may also be reductions in non-suicidal self-injury, although no study has investigated this potential benefit. Given that associations between perfectionism and psychopathology are observed across both adults and adolescents, the need for the development of interventions targeting adolescents is essential for early intervention and prevention.
Methods


The present study will employ a randomised controlled trial to examine the efficacy of 8-week guided Internet-delivered cognitive-behavioural therapy for perfectionism in adolescents compared to a waitlist control group. The primary outcome is perfectionism, and secondary outcomes include symptoms of psychological disorders, well-being, and non-suicidal self-injury. Outcomes will be assessed at pre-intervention, post-intervention, 1-month follow-up, 3-month follow-up, and 6-month follow-up. A minimum of 240 participants will be recruited online through social media, Australian universities, and schools across Australia. Generalised linear mixed models will be used to test for changes in outcomes between the intervention group and the waitlist control.
Discussion


The outcomes of this trial will contribute to the literature on perfectionism and psychopathology in adolescents, as well as the efficacy of guided Internet-delivered interventions for adolescents.
Trial registration


The trial was registered on the 20th of June 2019 at the Australia New Zealand Clinical Trials Registry (ACTRN12619000881134).
Trial status


This is protocol version 1.0. Participant recruitment began on 31 July 2019 and is still actively running with an anticipated completion date in the fourth quarter of 2020.",2020,There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up.,"['20 th  of June 2019 at the Australia New Zealand Clinical Trials Registry (ACTRN12619000881134).Trial StatusThis is protocol version 1.0', 'Adolescents', 'adolescents', '240 participants will be recruited online through social media, Australian universities, and schools across Australia']","['guided Internet-delivered cognitive-behavioural therapy', 'Guided Internet-Delivered Cognitive Behaviour Therapy']","['perfectionism, and secondary outcomes include symptoms of psychological disorders, well-being, and non-suicidal self-injury']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",,0.13653,There is a growing body of evidence suggesting that Internet-delivered cognitive-behavioural therapy for perfectionism reduces perfectionism and symptoms of psychological disorders and that reductions are maintained at 3-month and 6-month follow-up.,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Howell', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Tonta', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Egan', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Penelope A', 'Initials': 'PA', 'LastName': 'Hasking', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Boyes', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'McEvoy', 'Affiliation': 'Centre for Clinical Interventions, Western Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'School of Psychology, Curtin University, Western Australia.'}]",Internet interventions,['10.1016/j.invent.2020.100342']
1921,32870448,Mechanical Support in Early Cardiogenic Shock: What Is the Role of Intra-aortic Balloon Counterpulsation?,"PURPOSE OF REVIEW


We aim to summarize recent insights and provide an up-to-date overview on the role of intra-aortic balloon pump (IABP) counterpulsation in cardiogenic shock (CS).
RECENT FINDINGS


In the largest randomized controlled trial (RCT) of patients with CS after acute myocardial infarction (AMICS), IABP did not lower mortality. However, recent data suggest a role for IABP in patients who have persistent ischemia after revascularization. Moreover, in the growing population of CS not caused by acute coronary syndrome (ACS), multiple retrospective studies and one small RCT report on significant hemodynamic improvement following (early) initiation of IABP support, which allowed bridging of most patients to recovery or definitive therapies like heart transplant or a left ventricular assist device (LVAD). Routine use of IABP in patients with AMICS is not recommended, but many patients with CS either from ischemic or non-ischemic cause may benefit from IABP at least for hemodynamic improvement in the short term. There is a need for a larger RCT regarding the role of IABP in selected patients with ACS, as well as in patients with non-ACS CS.",2020,"In the largest randomized controlled trial (RCT) of patients with CS after acute myocardial infarction (AMICS), IABP did not lower mortality.","['patients with CS after acute myocardial infarction (AMICS', 'patients who have persistent ischemia after revascularization', 'cardiogenic shock (CS', 'Early Cardiogenic Shock', 'patients with AMICS']","['aortic balloon pump (IABP) counterpulsation', 'IABP']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0010216', 'cui_str': 'Counterpulsation'}]",[],,0.0864862,"In the largest randomized controlled trial (RCT) of patients with CS after acute myocardial infarction (AMICS), IABP did not lower mortality.","[{'ForeName': 'Jesse R', 'Initials': 'JR', 'LastName': 'Kimman', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands. j.kimman@erasmusmc.nl.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Endeman', 'Affiliation': 'Department of Intensive Care Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jasper J', 'Initials': 'JJ', 'LastName': 'Brugts', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.'}, {'ForeName': 'Alina A', 'Initials': 'AA', 'LastName': 'Constantinescu', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.'}, {'ForeName': 'Olivier C', 'Initials': 'OC', 'LastName': 'Manintveld', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dubois', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.'}, {'ForeName': 'Corstiaan A', 'Initials': 'CA', 'LastName': 'den Uil', 'Affiliation': 'Department of Cardiology, Thorax Center, Erasmus University Medical Center, Doctor Molewaterplein 40, 3015 GD, Rotterdam, the Netherlands.'}]",Current heart failure reports,['10.1007/s11897-020-00480-0']
1922,32870473,Immunotherapy in Breast Cancer: Current Practice and Clinical Challenges.,"Immunotherapy is currently approved for a subset of patients diagnosed with advanced triple negative breast cancer (TNBC), based on the phase III randomized controlled trial, IMpassion130. The anti-programmed cell death ligand-1 (PD-L1) immune checkpoint inhibitor atezolizumab combined with nanoparticle albumin-bound (nab)-paclitaxel is currently the standard first-line therapy in patients with metastatic TNBC who have a PD-L1-positive peritumoral immune infiltrate. Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being extensively evaluated. A substantial need exists for the identification of patient characteristics, disease settings, immune markers, ideal partners for combination with immune checkpoint inhibitors, and the ideal sequence with traditional anticancer therapies. Additionally, in light of the results of the KEYNOTE-522 study of adjuvant pembrolizumab in TNBC, evaluation of immunotherapy in the early disease setting is a subject of great interest. This review article discusses current knowledge on immune checkpoint inhibitors in clinical practice, and provides an overview of a variety of markers evaluated to predict benefit of immunotherapy and of promising new strategies to enhance immune response and enable more patients to benefit from immunotherapy.",2020,"Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being extensively evaluated.","['Breast Cancer', 'patients diagnosed with advanced triple negative breast cancer (TNBC', 'patients with metastatic TNBC who have a PD-L1-positive peritumoral immune infiltrate']","['Immunotherapy', 'atezolizumab combined with nanoparticle albumin-bound (nab)-paclitaxel']",[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]",[],,0.0359073,"Although this approval is limited to only a subset of patients, strategies to expand indications in breast cancer for this treatment modality are being extensively evaluated.","[{'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'de Melo Gagliato', 'Affiliation': 'Centro Oncológico da Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Buzaid', 'Affiliation': 'Centro Oncológico da Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Perez-Garcia', 'Affiliation': 'IOB Institute of Oncology, Quiron Group, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': 'IOB Institute of Oncology, Quiron Group, Barcelona, Spain. jacortes@vhio.net.'}]","BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy",['10.1007/s40259-020-00436-9']
1923,32873496,The Protective Impact of Telemedicine on Persons With Dementia and Their Caregivers During the COVID-19 Pandemic.,"OBJECTIVES


Social distancing under the COVID-19 pandemic has restricted access to community services for older adults with neurocognitive disorder (NCD) and their caregivers. Telehealth is a viable alternative to face-to-face service delivery. Telephone calls alone, however, may be insufficient. Here, we evaluated whether supplementary telehealth via video-conferencing platforms could bring additional benefits to care-recipient with NCD and their spousal caregivers at home.
PARTICIPANTS


Sixty older adults NCD-and-caregiver dyads were recruited through an activity center.
DESIGN, INTERVENTION


The impact of additional services delivered to both care-recipient and caregiver through video conference (n = 30) was compared with telehealth targeted at caregivers by telephone only (n = 30), over 4 weeks in a pretest-post-test design. Interviews and questionnaires were conducted at baseline and study's end.
MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50). It also reversed the falling trend in quality of life observed in the telephone only group (QoL-AD, η p 2  = 0.23). Varying degrees of improvements in physical and mental health (Short-Form 36 v2), perceived burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale) were observed among caregivers in the video-conferencing group, which were absent in the telephone-only group (η p 2  = 0.23-0.51).
CONCLUSION


Telemedicine by video conference was associated with improved resilience and wellbeing to both people with NCD and their caregivers at home. The benefits were visible already after 4 weeks and unmatched by telephone alone. Video conference as the modus operandi of telehmedicine beyond the context of pandemic-related social distancing should be considered.",2020,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","['Persons With Dementia and Their Caregivers During the COVID-19 Pandemic', 'Sixty older adults NCD-and-caregiver dyads were recruited through an activity center', 'older adults with neurocognitive disorder (NCD) and their caregivers']","['additional services delivered to both care-recipient and caregiver through video conference (n\u202f=\u202f30) was compared with telehealth targeted at caregivers by telephone', 'Telemedicine']","['physical and mental health', 'quality of life', 'burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale', 'Montreal Cognitive Assessment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",60.0,0.061643,"MEASUREMENTS, RESULTS


Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2  = 0.50).","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department (EWHY), Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Salvation Army Hong Kong & Macau Command, Tai Po Multi-service Centre for Senior Citizen.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Women's Welfare Club Western District, Hong Kong Chung Hok Elderly Centre, Hong Kong, China.""}, {'ForeName': 'Daniel Ting-Hoi', 'Initials': 'DT', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Yee', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.07.019']
1924,32873500,Young Adults Have Worse Outcomes Than Older Adults: Secondary Analysis of a Medication Trial for Opioid Use Disorder.,"PURPOSE


Young adults are disproportionately affected by the current opioid crisis. Although medications for opioid use disorder are broadly effective, with reductions in morbidity and mortality, the particular effectiveness of medications for opioid use disorder among young adults is less well understood.
METHODS


This secondary analysis compared young adults (aged 18-25 years) with older adults (aged ≥26 years) in a large comparative effectiveness trial (""XBOT"") that randomized subjects to extended-release naltrexone or sublingual buprenorphine-naloxone for 6 months. Opioid relapse was defined by opioid use over four consecutive weeks or seven consecutive days, using urine testing and self-report.
RESULTS


Among subjects in the intention-to-treat sample (n = 570, all randomized participants), a main effect of age group was found, with higher relapse rates among young adults (70.3%) compared with older adults (58.2%), with an odds ratio of 1.72 (95% confidence interval = 1.08-2.70), p = .02. In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06). Among the intention-to-treat sample, survival analysis revealed a significant time-by-age group interaction (p = .01) with more relapse over time in young adults. No significant interactions between age and medication group were detected.
CONCLUSIONS


Young adults have increased rates of relapse compared with older adults, perhaps because of vulnerabilities that increase their risk for treatment dropout and medication nonadherence, regardless of medication assignment. These results suggest that specialized, developmentally informed interventions may be needed to improve retention and successful treatment of opioid use disorder among young adults.",2020,"In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06).","['Young Adults', 'Older Adults', 'young adults (aged 18-25 years) with older adults (aged ≥26 years', 'Young adults']",['naltrexone or sublingual buprenorphine-naloxone'],"['morbidity and mortality', 'rates of relapse', 'Opioid relapse', 'relapse rates']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.141861,"In the per-protocol sample (n = 474, only participants who started medication), relapse rates were higher among young adults (66.3%) compared with older adults (50.8%), with an odds ratio of 1.91 (95% confidence interval = 1.19-3.06).","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Mountain Manor Treatment Center/Maryland Treatment Centers, Baltimore, Maryland; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: mfishman@marylandtreatment.org.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wenzel', 'Affiliation': 'Mountain Manor Treatment Center/Maryland Treatment Centers, Baltimore, Maryland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Division of Mental Health Data Science, New York State Psychiatric Institute, New York, New York.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'Department of Psychiatry, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.038']
1925,32871530,Efficacy of light therapy for a college student sample with non-seasonal subthreshold depression: An RCT study.,"BACKGROUND


Light therapy has been successfully used to treat seasonal and non-seasonal depression, but there is limited evidence for its efficacy in subthreshold depression. This study examines the efficacy of light therapy for symptoms of depression and anxiety in non-seasonal subthreshold depression.
METHODS


College students with non-seasonal subthreshold depression were recruited. The participants were randomly allocated to one of the three conditions: high- (LT-5000 lux) and low-intensity (LT-500 lux) light therapy conditions and a waiting-list control condition (WLC). The primary outcome was Hamilton Depression Rating Scale (HAMD), and secondary outcomes were Beck Depression Inventory-II (BDI-II) and state anxiety inventory (SAI), which were assessed at baseline (Week 0), during the trial (Week 4), and after completion of the light therapy (Week 8).
RESULTS


A total of 142 participants completed the trial. The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition. For the LT-5000, LT-500, and WLC conditions by the end of the 8-week trial, a response on the HAMD was achieved by 70.0%, 42.0% and 19.0% of the participants, and remission was achieved by 76.0%, 54.0%, and 19.0%, respectively.
LIMITATIONS


The subjects were not followed up regularly after completion of the trial.
CONCLUSION


Light therapy, both at high- and low-intensity, was efficacious in the treatment of college students with non-seasonal subthreshold depression. High-intensity light therapy was superior to low-intensity light therapy by the end of an 8-week trial.",2020,"The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition.","['142 participants completed the trial', 'college students with non-seasonal subthreshold depression', 'College students with non-seasonal subthreshold depression were recruited', 'college student sample with non-seasonal subthreshold depression']","['High-intensity light therapy', 'high- (LT-5000 lux) and low-intensity (LT-500 lux) light therapy conditions and a waiting-list control condition (WLC', 'light therapy']","['HAMD', 'remission', 'LT-500 conditions', 'Hamilton Depression Rating Scale (HAMD), and secondary outcomes were Beck Depression Inventory-II (BDI-II) and state anxiety inventory (SAI']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0024176', 'cui_str': 'Luxembourg'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",142.0,0.100785,"The LT-5000 (effect size [d] = 1.56, 95% CI: 1.15 to 1.98) and LT-500 conditions (d = 0.84, 95% CI: 0.43 to 1.26) were significantly superior to the WLC condition.","[{'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Imaging Center, First Affiliated Hospital of Jinan University, Guangzhou 510632, China.'}, {'ForeName': 'Kwok-Fai', 'Initials': 'KF', 'LastName': 'So', 'Affiliation': 'Guangdong-Hongkong-Macau Institute of CNS Regeneration, Ministry of Education CNS Regeneration Collaborative Joint Laboratory, Jinan University, Guangzhou 510632, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510530, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong 226001, China.'}, {'ForeName': 'Chaoran', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Guangdong-Hongkong-Macau Institute of CNS Regeneration, Ministry of Education CNS Regeneration Collaborative Joint Laboratory, Jinan University, Guangzhou 510632, China; Guangzhou Regenerative Medicine and Health Guangdong Laboratory, Guangzhou 510530, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong 226001, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tao', 'Affiliation': 'Department of Public Health and Preventive Medicine, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Division of Medical Psychology and Behavior Science, School of Basic Medicine, Jinan University, Guangzhou 510632, China; Center for Brain Science and Brain-Inspired Intelligence, Guangdong-Hong Kong-Macao Greater Bay Area, Guangzhou 510515, China. Electronic address: taoqian16@jnu.edu.cn.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.055']
1926,32871534,Neurocognitive performance of repeated versus single intravenous subanesthetic ketamine in treatment resistant depression.,"BACKGROUND


Ketamine demonstrated rapid antidepressant effects in treatment-resistant depression (TRD). However, evaluation of ketamine's neurocognitive effect in TRD is unclear. We aim to (1) characterize baseline neurocognitive performance as a predictor of the change in severity of depressive symptoms over time, and (2) investigate the association of six versus single intravenous (IV) ketamine and neurocognitive changes from baseline to the end of treatment.
METHODS


Subjects with TRD were randomized to receive either five IV midazolam followed by a single IV ketamine or six IV ketamine during a 12-day period. Depression symptom assessments occurred prior and 24 h after infusion days using the Montgomery-Åsberg Depression Rating Scale. Neurocognitive tasks were designed to test attention, memory, speed of processing, and set shifting using the CogState battery at baseline and at the end of treatment.
RESULTS


Better complex working memory at baseline predicted improvement in MADRS scores of ketamine (vs midazolam) after 5 infusions. Most, but not all, neurocognitive functions remained stable or improved after repeated or single ketamine. There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group. These cognitive improvements from baseline to the end of treatment were robust when controlling for age and changes in depression severity.
CONCLUSION


The study suggests that six IV ketamine compared to single IV ketamine has a mood independent procognitive effect among TRD patients. Large scale studies are needed to confirm whether ketamine enhances cognitive function in TRD.",2020,"There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group.","['Subjects with TRD', 'TRD patients']","['Ketamine', 'single intravenous (IV) ketamine', 'ketamine', 'subanesthetic ketamine', 'ketamine or six IV ketamine', 'midazolam']","['speed of processing, set shifting, and spatial working memory', 'neurocognitive functions', 'Montgomery-Åsberg Depression Rating Scale', 'MADRS scores', 'Neurocognitive performance', 'Depression symptom assessments']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.07502,"There was a greater differential effect of treatment on speed of processing, set shifting, and spatial working memory that favors subjects in the six ketamine group.","[{'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Geriatric Psychiatrist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA. Electronic address: paulo.shiroma@va.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Statistician/Research Methodologist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor/Research Associate, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wels', 'Affiliation': 'Staff Anesthesiologist, Minneapolis VA Health Care System, Mental Health Service Line; and Clinical Instructor, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'C Sophia', 'Initials': 'CS', 'LastName': 'Albott', 'Affiliation': 'Assistant Professor, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Staff Psychologist, Minneapolis VA Health Care System, Mental Health Service Line; and Associate Professor of Psychiatry, University of Minnesota Medical School, Minneapolis, MN.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Tye', 'Affiliation': 'Senior Research Fellow, Queensland Brain Institute, The University of Queensland, Queensland, Australia; Assistant Professor Psychiatry, Psychology and Pharmacology Translational Neuroscience Laboratory, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Drs. T.J. and Ella M. Arneson Land-Grant Chair in Human Behavior, Professor of Psychiatry, Vice Chair for Research Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.058']
1927,32871535,Effect of adjunctive pimavanserin on suicidal ideation in patients with major depression: Analysis of the CLARITY study.,"BACKGROUND


Up to 15% of patients with major depressive disorder (MDD) attempt suicide and up to 2% complete suicide. This was a post-hoc analysis aimed to evaluate the risk of suicide ideation and behavior associated with adjunctive pimavanserin treatment in adults with MDD.
METHODS


CLARITY was a randomized, double-blind, placebo-controlled study in patients with MDD and an inadequate response to a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). For this post-hoc analysis, the primary endpoint was mean change from baseline for HAMD item 3 (suicide). The incidence of suicidal ideation or behavior was also assessed from the Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events.
RESULTS


During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431). At any post-baseline assessment, suicidal ideation on the C-SSRS was reported in 28 (18.1%) of patients with placebo and 9 (17.3%) with pimavanserin during Stage 1 and in 7 (20.7%) with placebo and 4 (13.8%) with pimavanserin during Stage 2. No events of suicidal behavior were observed with either placebo or pimavanserin.
LIMITATIONS


The post hoc nature, exclusion of patients with any history of suicide from the primary study, and the small number of patients who demonstrated evidence of suicidal ideation.
CONCLUSIONS


Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD. Further study is needed to verify these results.",2020,"During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431).","['patients with major depressive disorder (MDD', 'patients with MDD', 'adults with MDD', 'patients with major depression', 'patients with MDD and an inadequate response to a']","['adjunctive pimavanserin', 'placebo', 'selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI']","['LS mean change for HAMD Item 3', 'incidence of suicidal ideation or behavior', 'suicidal ideation on the C-SSRS', 'Columbia-Suicide Severity Rating Scale (C-SSRS) and reports of adverse events', 'suicidal ideation', 'suicidal behavior']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1319313', 'cui_str': 'Norepinephrine reuptake inhibitor-containing product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",,0.255115,"During Stage 1, LS mean change for HAMD Item 3 was reduced from baseline at each week with pimavanserin with a significant difference between pimavanserin and placebo at Week 3 (p=0.012, effect size: 0.431).","[{'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: rcshelton@uabmc.edu.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.051']
1928,32871552,Dynamic Balance in Athletes With Intellectual Disability: Effect of Dynamic Stretching and Plyometric Warm-Ups.,"CONTEXT


Athletes with intellectual disability (ID) have a high risk of injury while participating in various sports. Warm-up (WU) is the most preventive measure to reduce injuries in sports.
OBJECTIVE


To investigate the effects of dynamic stretching WU (DS-WU) and plyometric WU (PL-WU) on dynamic balance in athletes with ID.
DESIGN


Crossover study.
SETTING


Research laboratory.
PARTICIPANTS


A total of 12 athletes with ID (age 24.5 [3.22] y, height 165.7 [8.4] cm, weight 61.5 [7.1] kg, intelligence quotient 61.1 [3.5]).
MAIN OUTCOME MEASURES


Dynamic balance was assessed using the Star Excursion Balance Test (SEBT) at pre-WU, post-WU, and 15 minutes post-WU for both the DS-WU and the PL-WU. A 2-way analysis of variance (3 sessions × 2 WU methods) with repeated-measures was used in this study.
RESULTS


Following the DS-WU, participants demonstrated significant improvements in the SEBT composite score post-WU (89.12% [5.54%] vs 87.04% [5.35%]; P < .01) and at 15 minutes post-WU (89.55% [5.28%] vs 87.04%, P < .01) compared with pre-WU. However, no significant difference between these two post-WU scores (post-WU and 15 min post-WU) was found. For the PL-WU, participants demonstrated a significant decrease in the SEBT composite score at post-WU (85.95% [5.49%] vs 87.02% [5.73%]; P < .05); however, these scores increased significantly at 15 minutes post-WU (88.60% [5.42%] vs 87.02% [5.49%]; P < .05) compared with that at pre-WU. The SEBT composite scores are significantly higher in the DS-WU than in the PL-WU at both post-WU sessions (P < .05).
CONCLUSION


Both DS-WU and PL-WU could improve dynamic balance and may be recommended as WUs in athletes with ID; however, particular caution should be exercised immediately after the PL-WU.",2020,"The SEBT composite scores are significantly higher in the DS-WU than in the PL-WU at both post-WU sessions (P < .05).
","['A total of 12 athletes with ID (age 24.5 [3.22', 'y, height 165.7 [8.4]\xa0cm, weight 61.5', 'Athletes With Intellectual Disability', 'athletes with ID', 'Athletes with intellectual disability (ID']","['Dynamic Stretching and Plyometric Warm-Ups', 'DS-WU', 'dynamic stretching WU (DS-WU) and plyometric WU (PL-WU']","['Dynamic balance', 'SEBT composite score post-WU', 'SEBT composite scores', 'Star Excursion Balance Test (SEBT', 'SEBT composite score', 'dynamic balance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]",12.0,0.0403822,"The SEBT composite scores are significantly higher in the DS-WU than in the PL-WU at both post-WU sessions (P < .05).
","[{'ForeName': 'Ghada', 'Initials': 'G', 'LastName': 'Jouira', 'Affiliation': ''}, {'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Srihi', 'Affiliation': ''}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ben Waer', 'Affiliation': ''}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': ''}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Sahli', 'Affiliation': ''}]",Journal of sport rehabilitation,['10.1123/jsr.2020-0100']
1929,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND


Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION


What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS


Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS


In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE


Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
1930,32883328,"The COVIRL002 Trial-Tocilizumab for management of severe, non-critical COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


Tocilizumab is a humanized monoclonal antibody which targets and inhibits interleukin-6 (IL-6) and has demonstrated efficacy in treating diseases associated with hyper-inflammation. Data are suggestive of tocilizumab as a potential treatment for patients with COVID-19 infection. The aim of this study is to determine the safety and efficacy of standard dose versus low dose tocilizumab in adults with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation on time to intubation, non-invasive ventilation and/or all-cause mortality.
TRIAL DESIGN


This trial is a phase 2, open label, two-stage, multicentre, randomised trial.
PARTICIPANTS


Adult subjects with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation requiring admission to hospital at St. Vincent's University Hospital and Mater Misericordiae University Hospital, Dublin, Ireland. Inclusion criteria Aged 18 years or older. Confirmed SARS-CoV2 infection (as defined by positive PCR). Evidence of hyper inflammatory state as evidenced by at least three of the following: Documented temperature >38°C in the past 48 hours, IL6 >40 pg/ml, or in its absence D-dimer >1.5 μgFEU /ml, Elevated CRP (>100mg/L) and/or a three-fold increase since presentation, Elevated ferritin X5 ULN, Elevated LDH (above the ULN), Elevated fibrinogen (above the ULN). Pulmonary infiltrates on chest imaging. Moderate to severe respiratory failure as defined by PaO 2 /FiO 2 ≤300mmHg.
INTERVENTION AND COMPARATOR


Intervention for participants in this trial is SOC plus Tocilizumab compared to SOC alone (comparator). For Stage 1, following randomisation, subjects will receive either (Arm 1) SOC alone or (Arm 2) SOC plus Tocilizumab (standard single dose - 8mg/kg, infused over 60 minutes. Once stage 1 has fully recruited, subsequent participants will be enrolled directly into Stage 2 and receive either (Arm 1) SOC plus Tocilizumab (standard single dose - 8mg/kg, infused over 60 minutes or (Arm 2) SOC plus Tocilizumab (standard single dose - 4mg/kg, infused over 60 minutes).
MAIN OUTCOMES


The primary endpoint for this study is the time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death within 28 days post randomisation.
RANDOMISATION


Eligible patients will be randomised (1:1) using a central register. Randomisation will be performed through an interactive, web-based electronic data capturing database. In stage 1, eligible participants will be randomised (1:1) to (Arm 1) SOC alone or to (Arm 2) SOC with single dose (8mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes. In stage 2, eligible participants will be randomised (1:1) to receive either (Arm 1) single, standard dose (8mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes or (Arm 2) reduced dose (4mg/kg, maximum 800mg) intravenous tocilizumab infused over 60 minutes.
BLINDING


This study is open label. The study will not be blinded to investigators, subjects, or medical or nursing staff. The trial statistician will be blinded for data analysis and will be kept unaware of treatment group assignments. To facilitate this, the randomisation schedule will be drawn up by an independent statistician and objective criteria were defined for the primary outcome to minimize potential bias.
NUMBERS TO BE RANDOMISED


In stage 1, 90 subjects will be randomised 1:1, 45 to SOC and 45 subjects to SOC plus Tocilizumab (8mg/kg, infused over 60 minutes). In stage 2, sample size calculation for the dose evaluation stage will use data generated from stage 1 using the same primary endpoint as in stage 1.
TRIAL STATUS


The COVIRL002 trial (Protocol version 1.4, 13 th  May 2020) commenced in May 2020 at St. Vincent's University Hospital and Mater Misericordiae University Hospital, Dublin, Ireland. Recruitment is proceeding with the aim to achieve the target sample size on or before April 2021.
TRIAL REGISTRATION


COVIRL002 was registered 25 June 2020 under EudraCT number: 2020-001767-86 and Protocol identification: UCDCRC/20/02.
FULL PROTOCOL


The full protocol for COVIRL002 is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,Moderate to severe respiratory failure as defined by PaO 2 /FiO 2,"['patients with COVID-19 infection', 'adults with severe', 'Aged 18 years or older', ""Adult subjects with severe, non-critical, PCR-confirmed COVID-19 infection with evidence of progressive decline in respiratory function and evolving systemic inflammation requiring admission to hospital at St. Vincent's University Hospital and Mater Misericordiae University Hospital, Dublin, Ireland""]","['intravenous tocilizumab', 'SOC plus Tocilizumab', 'SOC alone or (Arm 2) SOC plus Tocilizumab', 'Tocilizumab', 'SOC alone (comparator', 'tocilizumab']","['severe respiratory failure', 'time to a composite primary endpoint of progression to intubation and ventilation, non-invasive ventilation or death within 28 days post randomisation', 'safety and efficacy', 'Elevated ferritin X5 ULN, Elevated LDH (above the ULN), Elevated fibrinogen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0743912', 'cui_str': 'Ferritin increased'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}]",90.0,0.480612,Moderate to severe respiratory failure as defined by PaO 2 /FiO 2,"[{'ForeName': 'Aoife', 'Initials': 'A', 'LastName': 'Cotter', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland. deborah.wallace@ucd.ie.'}, {'ForeName': 'Cormac', 'Initials': 'C', 'LastName': 'McCarthy', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Feeney', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': ""O'Neill"", 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stack', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'McCarthy', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin, Ireland.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Hussain', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Alvarez Barco', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Doran', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallon', 'Affiliation': 'School of Medicine, University College Dublin, Dublin, Ireland.'}]",Trials,['10.1186/s13063-020-04680-w']
1931,32883333,Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial.,"BACKGROUND


Bronchopulmonary dysplasia (BPD) is still a common complication in very premature infants. At present, there is no effective treatment for BPD. Glucocorticoids are drugs commonly used to prevent or treat BPD before and after birth. In very premature infants with high risk factors for BPD, early use of dexamethasone can reduce the rate of death and/or BPD but may cause long-term adverse neurodevelopmental outcomes. Hydrocortisone (HC), as an alternative drug to dexamethasone, has been increasingly used to prevent BPD. However, no study has reported the efficacy and safety of HC to treat early BPD diagnosed at postnatal day (PND) 28.
METHODS


This study protocol is for a multicenter double-blind randomized controlled trial of low-dose HC in the treatment of early BPD. Early BPD infants will be randomly assigned to the HC treatment group or control group. Infants in the HC group will receive 0.5 mg/kg HC twice a day for 7 days and then 0.5 mg/kg HC once a day for 3 days. The control group will be given the same volume of placebo and no intervention on the basis of routine treatment. The primary outcome is survival without moderate or severe BPD at 36 weeks postmenstrual age. Secondary outcomes are the short- and long-term effects on growth, metabolism, neurodevelopment, and other possible complications.
DISCUSSION


This trial will determine the efficacy and safety of low-dose HC administration compared to placebo for the reduction of moderate or severe BPD at 36 weeks postmenstrual age in very preterm infants with early BPD.
TRIAL REGISTRATION


China Clinical Trial Registration Center ChiCTR1900021854 . Registered on 13 March 2019.",2020,"In very premature infants with high risk factors for BPD, early use of dexamethasone can reduce the rate of death and/or BPD but may cause long-term adverse neurodevelopmental outcomes.","['very preterm infants', 'moderate or severe BPD at 36\u2009weeks postmenstrual age in very preterm infants with early BPD', 'very premature infants', 'Early BPD infants', 'Bronchopulmonary dysplasia (BPD', 'early BPD']","['Glucocorticoids', 'placebo and no intervention', 'Hydrocortisone (HC', 'HC', 'dexamethasone', 'placebo', 'Hydrocortisone', 'low-dose HC']","['efficacy and safety', 'short- and long-term effects on growth, metabolism, neurodevelopment, and other possible complications', 'rate of death and/or BPD', 'survival without moderate or severe BPD']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0023983', 'cui_str': 'Effects, Longterm'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.362114,"In very premature infants with high risk factors for BPD, early use of dexamethasone can reduce the rate of death and/or BPD but may cause long-term adverse neurodevelopmental outcomes.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Sichuan Provincial Hospital for Women and Children, Chengdu, Sichuan, China.'}, {'ForeName': 'Shuqiang', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ""Department of Neonatology, Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'He', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.'}, {'ForeName': 'Deshuang', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wieg', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China. Christian.Wieg@klinikum-ab-alz.de.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China. leixiaopingde@126.com.'}]",Trials,['10.1186/s13063-020-04698-0']
1932,32883337,Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial.,"BACKGROUND


As the USA grapples with an opioid epidemic, medical emergency departments (EDs) have become a critical setting for intervening with opioid-dependent patients. Brief interventions designed to bridge the gap from acute ED care to longer-term treatment have shown limited efficacy for this population. Strength-based case management (SBCM) has shown strong effects on treatment linkage among patients with substance use disorders in other healthcare settings. This study aimed to investigate whether SBCM is an effective model for linking opioid-dependent ED patients with addiction treatment and pharmacotherapy. Here, we describe the implementation and challenges of adapting SBCM for the ED (SBCM-ED). Study rationale, design, and baseline characteristics are also described.
METHODS


This study compared the effects of SBCM-ED to screening, assessment, and referral alone (SAR) on treatment linkage, substance use, and functioning. We recruited participants from a public hospital in NYC. Working alliance between case managers and participants and the feasibility of SBCM implementation were evaluated. Baseline data from the randomized sample were analyzed for group equivalency. Outcomes analyses are forthcoming.
RESULTS


Three hundred adult participants meeting DSM-IV criteria for opioid dependence were randomly assigned to either SBCM, in which they received a maximum of six case management sessions within 90 days of enrollment, or SAR, in which they received a comprehensive referral list and pamphlet outlining drug use consequences. No significant differences were found between groups at baseline on demographic or substance use characteristics. All SAR participants and 92.6% of SBCM-ED participants initiated their assigned intervention. Over half of SBCM-ED first sessions occurred in the ED on the day of enrollment. Case managers developed a strong working alliance with SBCM-ED participants after just one session.
CONCLUSION


Interventions that exceed SBIRT were accepted by an opioid-dependent patient population seen in an urban medical ED. At the time of study funding, this trial was one of the first to focus specifically on this population in this challenging setting. The successful implementation of SBCM demonstrates its adaptability to the ED and may serve as a potential model for EDs seeking to adopt an intervention that overcomes the barrier between the ED encounter and more intensive treatment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02586896 . Registered on 27 October 2015.",2020,No significant differences were found between groups at baseline on demographic or substance use characteristics.,"['We recruited participants from a public hospital in NYC', 'Three hundred adult participants meeting DSM-IV criteria for opioid dependence', 'dependent patients presenting in medical emergency departments', 'patients with substance use disorders in other healthcare settings', 'ED patients with addiction treatment and pharmacotherapy']","['Strength-based case management (SBCM', 'comprehensive referral list and pamphlet outlining drug use consequences', 'strength-based case management for opioid', 'SBCM']",[],"[{'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0600661', 'cui_str': 'Outlines'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",[],300.0,0.0812963,No significant differences were found between groups at baseline on demographic or substance use characteristics.,"[{'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Regis', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Meyers-Ohki', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Mennenga', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Peter P', 'Initials': 'PP', 'LastName': 'Greco', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Glisker', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Kolaric', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'McCormack', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Rapp', 'Affiliation': 'Wright State University, Boonshoft School of Medicine, Dayton, OH, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Bogenschutz', 'Affiliation': 'NYU Grossman School of Medicine, New York, USA. Michael.Bogenschutz@nyulangone.org.'}]",Trials,['10.1186/s13063-020-04684-6']
1933,32883351,Using an ultraviolet cabinet improves compliance with the World Health Organization's hand hygiene recommendations by undergraduate medical students: a randomized controlled trial.,"BACKGROUND


Appropriate hand hygiene (HH) is key to reducing healthcare-acquired infections. The World Health Organization (WHO) recommends education and training to improve HH knowledge and compliance. Physicians are ranked among the worst of all healthcare workers for compliant handrubbing with its origin probably being the failure to learn this essential behavior during undergraduate medical studies. This study evaluated if the use of Ultraviolet-cabinets (UVc) for fluorescent-alcohol-based handrubs (AHR) during an undergraduate medical student training improved the compliance rate to the WHO hand hygiene recommendations (completeness of AHR application and HH opportunities).
METHODS


This randomized trial compared a HH training with personal feedback (using UVc) to a control group. The first year, the students (2nd degree) were convened by groups (clusters) of 6-9 for a demonstration of the correct execution of WHO procedure. Randomization by cluster was done prior HH training. In the control group, the students hand rubbed under visual supervision of a tutor. In the intervention group after the same visual supervision, completeness of fluorescent-AHR hand application was recorded under UVc and was shown to the student. The intervention group had free access to the UVc until complete application. HH practices were included in simulation sessions for the both groups. One year after (3rd degree), all the students were asked to hand rub with fluorescent-AHR. A tutor (blinded to the study group) assessed the completeness of hand application under UVc and the compliance with the WHO opportunities. Complete application of AHR was defined as fluorescence for all the surfaces of hands and wrists.
RESULTS


242 students participated (140 in the intervention group and 102 in the control group). One year after the initial training, the rate of complete application of AHR was doubled in the intervention group (60.0% vs. 30.4%, p < 0.001). In a multivariate analysis which included gender, additional HH or UVc training, surgical traineeship and regular use of AHR, the hazard ratio for the intervention was 3.84 (95%CI: 2.09-7.06). The compliance with the HH WHO's opportunities was increased in the intervention group (58.1% vs. 42.4%, p < 0.018).
CONCLUSION


Using UVc for undergraduate medical students education to hand hygiene improves their technique and compliance with WHO recommendations.",2020,"opportunities was increased in the intervention group (58.1% vs. 42.4%, p < 0.018).
","['242 students participated (140 in the intervention group and 102 in the control group', 'undergraduate medical students', ""WHO's""]","['ultraviolet cabinet', 'HH training with personal feedback (using UVc', 'Ultraviolet-cabinets (UVc) for fluorescent-alcohol-based handrubs (AHR', 'HH']",['rate of complete application of AHR'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0179481', 'cui_str': 'Cabinet'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",242.0,0.0310349,"opportunities was increased in the intervention group (58.1% vs. 42.4%, p < 0.018).
","[{'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Dray', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Lehingue', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Valera', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Nouguier', 'Affiliation': ""Service d'Aide Médicale Urgente (SAMU), Assistance Publique Hôpitaux de Marseille, CHU Timone, Marseille, France.""}, {'ForeName': 'Michel Salah', 'Initials': 'MS', 'LastName': 'Boussen', 'Affiliation': ""Département d'Anesthésie Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Timone, Marseille, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Daviet', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Bastian', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Pilarczik', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Jousset', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Le Floch', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Georgette', 'Initials': 'G', 'LastName': 'Grech', 'Affiliation': 'Comité de Lutte Contre les Infections Nosocomiales (CLIN), Assistance Publique Hôpitaux de Marseille, CHU Nord, Marseille, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Leonetti', 'Affiliation': 'Faculté de Médecine de Marseille, Aix Marseille University, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Papazian', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France.'}, {'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Cassir', 'Affiliation': 'Comité de Lutte Contre les Infections Nosocomiales (CLIN), Assistance Publique Hôpitaux de Marseille, CHU Nord, Marseille, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Forel', 'Affiliation': 'Médecine Intensive Réanimation, Assistance Publique Hôpitaux de Marseille, CHU Nord, Chemin des Bourrely, 13015, Marseille, France. jean-marie.forel@ap-hm.fr.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00808-4']
1934,32883362,A seven-gene signature model predicts overall survival in kidney renal clear cell carcinoma.,"BACKGROUND


Kidney renal clear cell carcinoma (KIRC) is a potentially fatal urogenital disease. It is a major cause of renal cell carcinoma and is often associated with late diagnosis and poor treatment outcomes. More evidence is emerging that genetic models can be used to predict the prognosis of KIRC. This study aimed to develop a model for predicting the overall survival of KIRC patients.
RESULTS


We identified 333 differentially expressed genes (DEGs) between KIRC and normal tissues from the Gene Expression Omnibus (GEO) database. We randomly divided 591 cases from The Cancer Genome Atlas (TCGA) into training and internal testing sets. In the training set, we used univariate Cox regression analysis to retrieve the survival-related DEGs and futher used multivariate Cox regression with the LASSO penalty to identify potential prognostic genes. A seven-gene signature was identified that included APOLD1, C9orf66, G6PC, PPP1R1A, CNN1G, TIMP1, and TUBB2B. The seven-gene signature was evaluated in the training set, internal testing set, and external validation using data from the ICGC database. The Kaplan-Meier analysis showed that the high risk group had a significantly shorter overall survival time than the low risk group in the training, testing, and ICGC datasets. ROC analysis showed that the model had a high performance with an AUC of 0.738 in the training set, 0.706 in the internal testing set, and 0.656 in the ICGC external validation set.
CONCLUSION


Our findings show that a seven-gene signature can serve as an independent biomarker for predicting prognosis in KIRC patients.",2020,"The Kaplan-Meier analysis showed that the high risk group had a significantly shorter overall survival time than the low risk group in the training, testing, and ICGC datasets.","['kidney renal clear cell carcinoma', 'Kidney renal clear cell carcinoma (KIRC']",[],['overall survival time'],"[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",591.0,0.025324,"The Kaplan-Meier analysis showed that the high risk group had a significantly shorter overall survival time than the low risk group in the training, testing, and ICGC datasets.","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Zijin', 'Initials': 'Z', 'LastName': 'Xiang', 'Affiliation': 'Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xueru', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xiuting', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy, The Third Xiangya Hospital, Central South University, Changsha, 410013, Hunan, China. xdpeng@csu.edu.cn.'}]",Hereditas,['10.1186/s41065-020-00152-y']
1935,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND


Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM


To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN


Follow up study.
SUBJECTS


Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES


Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES


Continuous scores derived from all the measures.
RESULTS


67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION


There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
1936,32873406,Comparison of immunogenicity between candidate influenza A(H3N2) virus vaccine strains in Japan: A randomized controlled trial using a monovalent vaccine of A/Saitama/103/2014 (CEXP-002) and A/Hong Kong/4801/2014 (X-263).,"BACKGROUND


For the 2017-18 influenza season, A/Saitama/103/2014 (CEXP-002) (Saitama strain) was antigenically more similar to prior circulating strains than A/Hong Kong/4801/2014 (X-263) (Hong Kong strain) in a ferret model and was selected as the A(H3N2) vaccine virus strain in Japan. However, the Saitama strain grew poorly, and the Japanese government switched to the Hong Kong strain, raising public concerns of poor effectiveness. To enhance understanding of the correlation between antigenicity in experimental models and immunogenicity, as a surrogate measure of vaccine effectiveness, in the human population, we compared the immunogenicity of specially-prepared single dose monovalent influenza A(H3N2) vaccines containing the Saitama or the Hong Kong strain.
METHODS


A randomized controlled trial of 100 healthy adults aged 20-64 years (n = 50/group) was conducted. Virus neutralization assay was performed on sera from days 0 (pre-vaccination) and 21 (post-vaccination). Geometric mean titer (GMT), mean fold rise (MFR), seroconversion proportion (SCP), and seroprotection proportion (SPP) were calculated for vaccine strains and a representative circulating A(H3N2) virus strain (A/Osaka/188/2017).
RESULTS


For the Hong Kong strain, post-vaccination GMT was significantly higher in the Hong Kong vaccine recipients (1:546 vs 1:260, p < 0.01), but MFR, SCP, and SPP were similar for both vaccine groups. For the Saitama strain, post-vaccination GMT (1:116 vs 1:61, p = 0.01) and SPP (86% vs 68%, p = 0.03) were significantly higher in the Hong Kong vaccine recipients, but MFR and SCP were similar for both vaccine groups. Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
CONCLUSION


The Hong Kong vaccine induced better or equivalent immunogenicity in comparison to the Saitama vaccine. Our trial showed that antigenic similarity in experimental models does not necessarily correlate with immunogenicity in the human population.
CLINICAL TRIAL REGISTRATION


UMIN000029293.",2020,"Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
","['Japan', 'vaccine virus strain in Japan', '100 healthy adults aged 20-64\xa0years (n\xa0=\xa050/group']","['candidate influenza A(H3N2', 'monovalent vaccine of A/Saitama/103/2014 (CEXP-002) and A/Hong Kong/4801/2014 (X-263']","['MFR and SCP', 'MFR, SCP, and SPP', 'SPP', 'Geometric mean titer (GMT), mean fold rise (MFR), seroconversion proportion (SCP), and seroprotection proportion (SPP']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517671', 'cui_str': '263'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",100.0,0.0818063,"Against A/Osaka/188/2017, post-vaccination GMT and MFR were similar in both vaccine groups, but SCP (32% vs 4%, p < 0.01) and SPP (28% vs. 6%, p < 0.01) were significantly higher in the Hong Kong vaccine recipients.
","[{'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Kase', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Morikawa', 'Affiliation': 'Department of Virology, Osaka Institute of Public Health, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Kumashiro', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hiroi', 'Affiliation': 'Department of Virology, Osaka Institute of Public Health, Osaka, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nakata', 'Affiliation': 'Department of Virology, Osaka Institute of Public Health, Osaka, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan; Healthcare Management, College of Healthcare Management, Miyama, Japan; Clinical Epidemiology Research Center, SOUSEIKAI, Fukuoka, Japan.'}, {'ForeName': 'Motoki', 'Initials': 'M', 'LastName': 'Ishibashi', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Tsuru', 'Affiliation': 'SOUSEIKAI PS Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI, Fukuoka, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Ohfuji', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Wakaba', 'Initials': 'W', 'LastName': 'Fukushima', 'Affiliation': 'Department of Public Health, Osaka City University Graduate School of Medicine, Osaka, Japan; Research Center for Infectious Disease Sciences, Osaka City University Graduate School of Medicine, Osaka, Japan. Electronic address: wakaba@med.osaka-cu.ac.jp.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Hirota', 'Affiliation': 'Clinical Epidemiology Research Center, SOUSEIKAI, Fukuoka, Japan; College of Healthcare Management, Miyama, Japan.'}]",Vaccine,['10.1016/j.vaccine.2020.08.025']
1937,32873675,Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).,"INTRODUCTION


The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.
METHODS AND ANALYSIS


This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted.
ETHICS AND DISSEMINATION


This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC.
TRIAL REGISTRATION NUMBER


NCT03404583.",2020,"Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.
","['patients on sick leave due to common mental disorders', '220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date']","['control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform', 'Person-centred care (PCC', 'Person-centred eHealth intervention']",['composite score of changes in sick leave and self-efficacy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",220.0,0.164427,"Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context.
","[{'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Cederberg', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden matilda.cederberg@gu.se.'}, {'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Ali', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Ekman', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Glise', 'Affiliation': 'The Institute of Stress Medicine, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Ingibjörg H', 'Initials': 'IH', 'LastName': 'Jonsdottir', 'Affiliation': 'The Institute of Stress Medicine, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2020-037515']
1938,32873678,Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol.,"INTRODUCTION


Despite the non-negligible weight loss failure rate at midterm, Roux-en-Y gastric bypass (RYGB) remains the reference procedure in the treatment of morbid obesity with metabolic comorbidities. A recently emerged procedure, the single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S), could be more effective on weight loss with similar morbidity and lower weight loss failure rate than RYGB. We propose the first randomised, open, multicentre superiority trial comparing the SADI-S to RYGB (SADISLEEVE).
METHODS AND ANALYSIS


The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage. The secondary objectives are the evaluation of nutritional status, metabolic outcomes, overall complication rates and quality of life, within 2 years after surgery. Key inclusion criteria are obese patients with body mass index (BMI) ≥40 kg/m 2  or ≥35 kg/m 2  with at least one comorbid condition and candidate to a first bariatric procedure or after failure of sleeve gastrectomy. Patients randomised by minimisation in two arms, based on centre, surgery as a revisional procedure, presence of type 2 diabetes and BMI >50 kg/m 2  will be included over 2 years.A sample size of 166 patients in each group will have a power of 90% to detect a probability of 0.603 that excess weight loss in the RYGB arm is less than excess weight loss in the SADI-S arm with a 5% two-sided significance level. With a drop-out rate of 10%, it will be necessary to include 183 patients per group.
ETHICS AND DISSEMINATION


The study was approved by Institutional Review Board of Centre Hospitalier Universitaire Morvan (CPP1089-HPS1). Study was also approved by the French national agency for drug safety (2018061500148). Results will be reported in peer-reviewed scientific journals.
TRIAL REGISTRATION NUMBER


NCT03610256.",2020,The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage.,"['183 patients per group', 'obese patients with body mass index (BMI) ≥40\u2009kg/m 2  or ≥35']","['single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB', 'Roux-en-Y gastric bypass (RYGB', 'anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S', 'SADI-S to RYGB']","['efficacy and safety', 'nutritional status, metabolic outcomes, overall complication rates and quality of life', 'weight loss']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0399975', 'cui_str': 'Bypass of ileum'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0839635,The main objective is to demonstrate the superiority at 2 years after surgery of the SADI-S compared with RYGB in term of excess weight loss percentage.,"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, CarMeN Laboratory, INSERM 1060, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Tigran', 'Initials': 'T', 'LastName': 'Poghosyan', 'Affiliation': 'Department of Digestive, Oncologic and Bariatric Surgery; Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Inserm UMRS 1149, Université de Paris, Paris, France tigran.poghosyan@aphp.fr.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Delaunay', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Pelascini', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Iceta', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Sterkers', 'Affiliation': 'Department of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Barsamian', 'Affiliation': 'Department of Nutrition, Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, France.'}, {'ForeName': 'Litavan', 'Initials': 'L', 'LastName': 'Khamphommala', 'Affiliation': 'Department of Digestive, Hepatobiliary Surgery, Centre Hospitalier Privé Saint-Grégoire, Saint-Gregoire, Bretagne, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bin Dorel', 'Affiliation': 'Clinical Research Unit, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Maucort-Boulch', 'Affiliation': 'Department of Biostatistics, Hospices Civils de Lyon, Hôpital Edouard Herriot, Université Lyon 1, Lyon, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': 'Department of Nutrition, Specialized Center for Obesity Management, Assistance Publique - Hôpitaux de Paris, Hôpital européen Georges Pompidou, Université de Paris, Paris, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Specialized Center for Obesity Management, Hospices Civils de Lyon, Université Lyon 1, Lyon, France.'}]",BMJ open,['10.1136/bmjopen-2020-037576']
1939,32873681,Mesothelioma and Radical Surgery 2 (MARS 2): protocol for a multicentre randomised trial comparing (extended) pleurectomy decortication versus no (extended) pleurectomy decortication for patients with malignant pleural mesothelioma.,"INTRODUCTION


Mesothelioma remains a lethal cancer. To date, systemic therapy with pemetrexed and a platinum drug remains the only licensed standard of care. As the median survival for patients with mesothelioma is 12.1 months, surgery is an important consideration to improve survival and/or quality of life. Currently, only two surgical trials have been performed which found that neither extensive (extra-pleural pneumonectomy) or limited (partial pleurectomy) surgery improved survival (although there was some evidence of improved quality of life). Therefore, clinicians are now looking to evaluate pleurectomy decortication, the only radical treatment option left.
METHODS AND ANALYSIS


The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma. The study will test the hypothesis that surgery and chemotherapy is superior to chemotherapy alone with respect to overall survival. Secondary outcomes include health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years. The QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.
ETHICS AND DISSEMINATION


Research ethics approval was granted by London - Camberwell St. Giles Research Ethics Committee (reference 13/LO/1481) on 7 November 2013. We will submit the results for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBERS


ISRCTN-ISRCTN44351742 and ClinicalTrials.gov-NCT02040272.",2020,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"['pleural mesothelioma', 'patients with malignant pleural mesothelioma']","['surgery-(extended) pleurectomy decortication-versus no surgery', 'pleurectomy decortication versus no (extended) pleurectomy decortication']","['health-related quality of life, progression-free survival, measures of safety (adverse events) and resource use to 2 years', 'survival and/or quality of life', 'quality of life', 'survival', 'overall survival', 'median survival']","[{'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0152463', 'cui_str': 'Pleurectomy'}, {'cui': 'C0007778', 'cui_str': 'Brain decortication'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.206517,The MARS 2 study is a UK multicentre open parallel group randomised controlled trial comparing the effectiveness and cost-effectiveness of surgery-(extended) pleurectomy decortication-versus no surgery for the treatment of pleural mesothelioma.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lim', 'Affiliation': 'Academic Division of Thoracic Surgery, Royal Brompton and Harefield NHS Trust, London, UK e.lim@rbht.nhs.uk.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Darlison', 'Affiliation': 'The Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Edwards', 'Affiliation': 'Cardiothoracic Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Elliott', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'Cancer Research UK Centre Leicester, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Popat', 'Affiliation': 'Department of Medicine, Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Rintoul', 'Affiliation': 'Department of Thoracic Oncology, Papworth Hospital NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Waller', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Ali', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bille', 'Affiliation': ""Thoracic Surgery, Guy's and Saint Thomas' Hospitals NHS Trust, London, UK.""}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Fuller', 'Affiliation': 'Respiratory Medicine, South Tyneside NHS Foundation Trust, South Shields, UK.'}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Ionescu', 'Affiliation': 'Lung Cancer, Aneurin Bevan University Health Board, Newport, UK.'}, {'ForeName': 'Manjusha', 'Initials': 'M', 'LastName': 'Keni', 'Affiliation': 'Oncology, Derby Teaching Hospitals NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kirk', 'Affiliation': 'Department of Thoracic Surgery, Golden Jubilee National Hospital, Clydebank, UK.'}, {'ForeName': 'Pek', 'Initials': 'P', 'LastName': 'Koh', 'Affiliation': 'Department of Oncology, New Cross Hospital, Wolverhampton, UK.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Department of Thoracic Surgery, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Talal', 'Initials': 'T', 'LastName': 'Mansy', 'Affiliation': 'Oncology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Maskell', 'Affiliation': 'Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Milton', 'Affiliation': 'Thoracic Surgery Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Dakshinamoorthy', 'Initials': 'D', 'LastName': 'Muthukumar', 'Affiliation': 'Oncology, Colchester Hospital University NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Pope', 'Affiliation': 'Clatterbridge Cancer Centre, Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': 'Plymouth Oncology Centre, University Hospitals Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'Riyaz', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Kent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shamash', 'Affiliation': 'Department of Medical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Tasigiannopoulos', 'Affiliation': 'The Oncology Care Team, Norfolk and Norwich University Hospital NHS Trust, Norwich, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Taylor', 'Affiliation': 'Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Treece', 'Affiliation': 'Heamatology and Oncology Unit, North West Anglia NHS Foundation Trust, Peterborough, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ashton', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Joyce', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Warnes', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stokes', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre (CTEU), University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-038892']
1940,32873686,Theory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP) among hypertensive patients in Nepal: study protocol for a feasibility randomised controlled trial.,"INTRODUCTION


Uncontrolled blood pressure is one of the main risk factors for cardiovascular disease and death in Low-income and middle-income countries. Improvements to medication adherence and lifestyle changes can be assisted by using mobile phone text messaging interventions. This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control '(TEXT4BP)', developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
METHODS AND ANALYSIS


The TEXT4BP intervention will be tested using a two-arm parallel-group, unblinded, individually randomised controlled trial. This feasibility study would recruit 200 clinically diagnosed hypertensive patients aged 18-69 years, currently receiving blood pressure-lowering medication for more than 3 months, visiting a tertiary healthcare facility in Kathmandu, Nepal. A nested qualitative study will assess the acceptability of the short message service intervention. The intervention group will receive text messages containing information on hypertension, diet, medication and physical activity three times a week for 3 months. The control group will receive standard care. At baseline and 3 months, measures of medication adherence, salt intake, physical activity and blood pressure will be collected. Feasibility measures, such as differential rates of recruitment and attrition rates, will be calculated. Acceptability of text message interventions will be studied using usability measures and in-depth interviews among intervention group participants. This pilot study is not funded.
ETHICS AND DISSEMINATION


This study has received ethics approval from the University of New South Wales Human Research Ethics Committee B (HC190357), Nepal Health Research Council (302/2019) and Institutional Review Committee of Kathmandu Medical College and Teaching Hospital Kathmandu, Nepal (030520192). The findings of the study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


ACTRN12619001213134.",2020,"This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control '(TEXT4BP)', developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
","['hypertensive patients in Nepal', '200 clinically diagnosed hypertensive patients aged 18-69 years, currently receiving blood pressure-lowering medication for more than 3\u2009months, visiting a tertiary healthcare facility in Kathmandu, Nepal']","['Theory-based mobile phone text messaging intervention for blood pressure control (TEXT4BP', 'text message interventions', 'TEXT4BP intervention', 'text messaging intervention']","['medication adherence, salt intake, physical activity and blood pressure', 'differential rates of recruitment and attrition rates']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",200.0,0.130284,"This study aims to test the feasibility and acceptability of a text messaging intervention for blood pressure control '(TEXT4BP)', developed based on behavioural change theory to improve treatment adherence and lifestyle change among hypertensive patients in Nepal.
","[{'ForeName': 'Buna', 'Initials': 'B', 'LastName': 'Bhandari', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia buna.bhandari@gmail.com.'}, {'ForeName': 'Padmanesan', 'Initials': 'P', 'LastName': 'Narasimhan', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Vaidya', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Jayasuriya', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040799']
1941,32871505,Social support modifies the association between hazardous drinking and depression symptoms among ART clients in Vietnam.,"INTRODUCTION


Hazardous drinking is widespread among people with HIV (PWH). PWH are also vulnerable to depression due to HIV-related social stigma, and social support can play an important role in improving mental health for this population. No studies have explored whether social support modifies the association of hazardous drinking and depressive symptoms among PWH.
METHODS


We used baseline data from a randomized controlled trial of two evidence-based alcohol reduction interventions among antiretroviral therapy clients in Vietnam. Hazardous alcohol use was defined as having a score ≥8 for men and ≥ 7 for women on the Alcohol Use Disorders Identification Test. The presence of depression symptoms was defined as a score ≥ 5 on the Patient Health Questionnaire-9. Social support was measured with a 5-question modified version of the Medical Outcomes Study Social Support Instrument. Crude (CPRs) and adjusted prevalence ratios (aPRs) of the association were presented.
RESULTS


Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52). Hazardous drinking and depression symptoms were not associated among those with high social support (aPR = 1.01;95%CI 0.76-1.35), but were associated among those with medium (aPR = 1.24;95%CI 0.92-1.69) and low social support (aPR = 1.71;95%CI 1.25-2.34).
CONCLUSIONS


Social support significantly modified the association between hazardous drinking and depression symptoms among ART clients in Vietnam. Interventions to decrease hazardous alcohol use are broadly indicated for PWH in Vietnam and other low-resource settings, but special attention or modifications may be needed to support mental health among those with lower levels of social support.",2020,"RESULTS


Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52).","['ART clients in Vietnam', 'people with HIV (PWH', 'antiretroviral therapy clients in Vietnam']",['evidence-based alcohol reduction interventions'],"['Hazardous drinking and depression symptoms', 'depression symptoms', 'hazardous drinking and depression symptoms', 'Crude (CPRs) and adjusted prevalence ratios (aPRs', 'likelihood of having depressive symptoms']","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",,0.0256045,"RESULTS


Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52).","[{'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Epidemiology, Institute of Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam. Electronic address: binhminh@live.unc.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Q X', 'Initials': 'QX', 'LastName': 'Bui', 'Affiliation': 'UNC Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Tran', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; UNC Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108249']
1942,32871885,Effect of a critical thinking intervention on stress management among undergraduates of adult education and extramural studies programs.,"OBJECTIVE


The objective of this study was to examine the effect of a critical thinking intervention (CTI) on stress management among undergraduates of adult education and extramural studies programs.
METHOD


A total of 44 undergraduates were randomly sorted into experimental and waitlist control groups. We used the Perceived Stress Scale for data collection at the pre-test, post-test, and follow-up stages. We used unpaired t and paired t-tests to analyze the data collected. SPSS version 22.0 was used for the data analyses (SPSS Inc., Chicago, IL).
RESULTS


It was shown that the CTI was effective in reducing the mean stress of the participants compared to the control group both in the post-test (t[42] = -22.453, P < .001) and follow-up periods (t[42] = -34.292, P < .001). There were statistically significant changes in the mean stress of participants in the experimental group from the pre-test to post-test phases (t[23] = 26.30, P = .000, r = .08], and from pre-test to follow-up(t[23] = 37.10, P = .000, r = .30). The mean stress of the participants in the experimental group from post-test to follow-up signified the sustained positive influence of the CTI on the mean stress (t[23] = 2.41, P = .000, r = .46) of the undergraduates.
CONCLUSION


This study adds to the literature by showing that a CTI is a valuable strategy for stress reduction in a university environment. Given that the CTI demonstrated the ability to reduce stress among undergraduates enrolled in adult education and extramural studies programs, we hope that similar interventions will be adopted to manage and prevent stress among students in other departments and disciplines.",2020,"It was shown that the CTI was effective in reducing the mean stress of the participants compared to the control group both in the post-test (t[42] = -22.453, P < .001) and follow-up periods (t[42] = -34.292, P < .001).","['undergraduates of adult education and extramural studies programs', 'A total of 44 undergraduates']","['critical thinking intervention (CTI', 'critical thinking intervention']",['mean stress'],"[{'cui': 'C0424936', 'cui_str': 'Adult education'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C4279941', 'cui_str': 'Critical Thinking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",44.0,0.0230015,"It was shown that the CTI was effective in reducing the mean stress of the participants compared to the control group both in the post-test (t[42] = -22.453, P < .001) and follow-up periods (t[42] = -34.292, P < .001).","[{'ForeName': 'Charity Chinelo', 'Initials': 'CC', 'LastName': 'Okide', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Ifeyinwa O', 'Initials': 'IO', 'LastName': 'Ezenwaji', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Moses O', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Rosemary Ogochukwu', 'Initials': 'RO', 'LastName': 'Igbo', 'Affiliation': 'Faculty of Education, Alex Ekwueme Federal University Ndufu-Alike Ikwo.'}, {'ForeName': 'Uzoamaka Lucynda', 'Initials': 'UL', 'LastName': 'Koledoye', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Nwakaego Ebele', 'Initials': 'NE', 'LastName': 'Ekwealor', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Osilike', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Nkechi Mercy', 'Initials': 'NM', 'LastName': 'Okeke', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Ngozi Justina', 'Initials': 'NJ', 'LastName': 'Igwe', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Ruphina U', 'Initials': 'RU', 'LastName': 'Nwachukwu', 'Affiliation': 'Department of Adult Education and Extra-Mural-Studies.'}, {'ForeName': 'Lambert Peter', 'Initials': 'LP', 'LastName': 'Ukanga', 'Affiliation': 'Department of Philosophy, University of Nigeria, Nsukka, P.M.B., Enugu State.'}, {'ForeName': 'Mulii Falaremi', 'Initials': 'MF', 'LastName': 'Olajide', 'Affiliation': 'Department of Adult Education and Community Development, Ibrahim Badamasi Babangida University, Lapai, Niger State.'}, {'ForeName': 'Anthonia Ekanibe', 'Initials': 'AE', 'LastName': 'Onuorah', 'Affiliation': 'Department of Guidance & Counselling, Enugu State University of Science and Technology, Enugu State, Nigeria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ujah', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Lambert K', 'Initials': 'LK', 'LastName': 'Ejionueme', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Godwin C', 'Initials': 'GC', 'LastName': 'Abiogu', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka, P.M.B.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}]",Medicine,['10.1097/MD.0000000000021697']
1943,32871891,Efficacy of oral Vitamin D supplementation in reducing body mass index and lipid profile in adolescents and young adults in Colombia: A pilot clinical trial protocol nested in the SIMBA cohort.,"BACKGROUND


In recent years, the role of vitamin D (VD) as a protective factor in cardiovascular disease has been recognized. Thus, there is a need to study the effect of vitamin D supplementation in the control of different cardiovascular risk factors and metabolic syndrome, especially in young populations where few studies have been conducted.
METHODS


Pilot study of a randomized, parallel two-arm, triple-blind clinical controlled trial in 150 adolescents and young adults in the city of Bucaramanga-Colombia. The intervention group will receive 1000 IU of VD and the control group 200 IU of VD daily for 15 weeks. The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio). Other variables will be analyzed such as assessment of dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and compliance with VD supplementation.
DISCUSSION


This study is innovative since there is little evidence from clinical trials in adolescents and young adults; similar studies are not known in our context. The results of this study may facilitate the recommendation of oral vitamin D supplementation in the population of interest. In addition, it is a low-cost and easy-to-apply intervention that could contribute to the formulation and implementation of health policies.
TRIAL REGISTRATION


NCT04377386.",2020,"The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio).","['adolescents and young adults', '150 adolescents and young adults in the city of Bucaramanga-Colombia', 'adolescents and young adults in Colombia']","['vitamin D supplementation', 'oral Vitamin D supplementation', 'oral vitamin D supplementation', 'vitamin D (VD']","['dietary intake, physical activity, sun exposure, cigarette and tobacco consumption and compliance with VD supplementation', 'body mass index and lipid profile', 'serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}]",150.0,0.109072,"The main outcomes are: serum calcifediol levels (25(OH) D), body mass index and lipid profile; secondary outcomes are complementary to the previous ones (skin folds, waist-hip ratio).","[{'ForeName': 'Norma C', 'Initials': 'NC', 'LastName': 'Serrano', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Romero', 'Affiliation': 'Universidad Industrial de Santander, Bucaramanga.'}, {'ForeName': 'Diana P', 'Initials': 'DP', 'LastName': 'Suárez', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Lyda Z', 'Initials': 'LZ', 'LastName': 'Rojas', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Edna Magaly', 'Initials': 'EM', 'LastName': 'Gamboa-Delgado', 'Affiliation': 'Universidad Industrial de Santander, Bucaramanga.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Forero', 'Affiliation': 'Hospital Internacional de Colombia, Piedecuesta, Colombia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Guio', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}, {'ForeName': 'Doris Cristina', 'Initials': 'DC', 'LastName': 'Quintero-Lesmes', 'Affiliation': 'Fundación Cardiovascular de Colombia, Floridablanca.'}]",Medicine,['10.1097/MD.0000000000021722']
1944,32871910,A randomized controlled trial study protocol of modified Mahuang-Fuzi-Xixin decoction in the treatment of patients with mild bronchial asthma during acute exacerbation.,"INTRODUCTION


These years, due to dissatisfaction with western medicine treatments, traditional Chinese medicine (TCM) becomes a main treatment for bronchial asthma patients. Lung and kidney yang deficiency syndrome is a common type of asthma and the Chinese herbal medicine formula modified Mahuang-Fuzi-Xixin (MFX) decoction is prescribed for mild bronchial asthma patients with acute exacerbation syndrome. However, there is not obvious evidence to support the efficacy and safety of modified MFX decoction the efficacy and safety to treat mild bronchial asthma and the mechanism of this disease is still unclear.
METHODS


A double-blind, placebo-controlled, randomized clinical trial was proposed by us. After a 10-day run-in period, 180 eligible objects will be recruited in this study. These subjects will be allocated to the experimental group or control group in a 1:1 ratio. Patients in the experimental group will take modified MFX decoction. At the same time, patients in the control group will receive a matched placebo. The budesonide inhalation powder will be used as a western medicine treatment for both groups. All subjects will receive 14 days of treatment and another 6 months of follow-up. The primary outcome is the mean change in peak expiratory flow rate from the baseline to 14 days in this research. The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage. This trial will also explore the association between the change of immunoglobulin E and modified MFX decoction treatment. Any side effects of the treatment will be recorded.
DISCUSSION


The results of this trial will provide the evidence for the effect of modified MFX decoction in patients with mild bronchial asthma during acute exacerbation. It also will explore the mechanism of this formula in the treatment of bronchial asthma, which will provide another treatment option for patients with mild bronchial asthma.",2020,"The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage.","['bronchial asthma patients', 'patients with mild bronchial asthma', 'mild bronchial asthma patients with acute exacerbation syndrome', 'patients with mild bronchial asthma during acute exacerbation']","['traditional Chinese medicine (TCM', 'Fuzi-Xixin (MFX) decoction', 'modified Mahuang-Fuzi-Xixin decoction', 'immunoglobulin E and modified MFX decoction treatment', 'placebo', 'modified MFX decoction']","['forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage', 'mean change in peak expiratory flow rate']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C3501467', 'cui_str': 'fuzi'}, {'cui': 'C4309118', 'cui_str': 'mahuang fuzi xixin'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}]",180.0,0.114145,"The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage.","[{'ForeName': 'Wenfan', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Maojuan', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jundong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Yuxin', 'Initials': 'Y', 'LastName': 'Hui', 'Affiliation': 'Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Niao', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': 'Department of Endocrinology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}]",Medicine,['10.1097/MD.0000000000021858']
1945,32871913,"Preoperative evaluation using external lumbar drainage for patients with posthemorrhagic hydrocephalus: A prospective, monocentric, randomized controlled trial.","BACKGROUND


External lumbar drainage (ELD) remains the most common used methods with a higher sensitivity before lumboperitoneal shunt (LPS) implantation to predict the shunt outcomes in the treatment of idiopathic normal pressure hydrocephalus. However, the benefits of such supplemental test have not been tested in the treatment of post-hemorrhagic hydrocephalus (PHH).
METHODS AND DESIGN


In the current trial, 100 eligible patients with PHH will be recruited and randomly assigned to the ELD group (study group) and non-ELD group (control group). Lumbar puncture (LP) will be performed for participants in non-ELD group. LP plus ELD will be performed for participants in ELD group, those who will then be investigated the suitability of potential LPS 4 days after ELD. Two independent and practiced assessors will collect the baseline data and evaluate each participant 4 days after ELD or LP, 1 day after LPS, at the time of discharge and 1 month after LPS. The primary outcome is the shunting outcomes 1 month after surgery. The secondary outcomes include the complications related to ELD, complications related to LPS, and Evens index at each evaluation point. Meanwhile, serious adverse events occurring at any time is recorded to determine the safety of this trial.
DISCUSSION


The results of this trial will demonstrate whether preoperative evaluation using temporary ELD for patients with PHH could attenuate the risk of LPS failure.
TRIAL REGISTRATION NUMBER


ChiCTR2000034094; Pre-results.",2020,"The secondary outcomes include the complications related to ELD, complications related to LPS, and Evens index at each evaluation point.","['idiopathic normal pressure hydrocephalus', 'patients with posthemorrhagic hydrocephalus', 'participants in non-ELD group', '100 eligible patients with PHH']","['External lumbar drainage (ELD', 'LP plus ELD', 'ELD', 'lumboperitoneal shunt (LPS) implantation', 'Lumbar puncture (LP', 'external lumbar drainage']","['complications related to ELD, complications related to LPS, and Evens index at each evaluation point', 'shunting outcomes 1 month after surgery']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0020258', 'cui_str': 'Normal pressure hydrocephalus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299564', 'cui_str': 'Posthemorrhagic hydrocephalus'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephalus'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1112158', 'cui_str': 'Lumboperitoneal shunt'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",100.0,0.220634,"The secondary outcomes include the complications related to ELD, complications related to LPS, and Evens index at each evaluation point.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Jingguo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Yikai', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Yicheng', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'You', 'Affiliation': 'Department of Neurosurgery.'}]",Medicine,['10.1097/MD.0000000000021872']
1946,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
1947,32871397,Neuromuscular training improves knee proprioception in athletes with a history of anterior cruciate ligament reconstruction: A randomized controlled trial.,"BACKGROUND


Athletes exhibit deficits in knee proprioception following anterior cruciate ligament reconstruction. Neuromuscular training programs improve knee proprioception in uninjured athletes; however, the effects on knee proprioception in athletes who have undergone anterior cruciate ligament reconstruction is not well understood. The purpose of this study was to examine the effects of a neuromuscular training program on knee proprioception in athletes who have returned to sport following anterior cruciate ligament reconstruction.
METHODS


Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12 months and returned to sport, participated in this randomized controlled trial. Athletes were randomly allocated to an experimental group (n = 12) that took part in an 8-week neuromuscular training program or a control group (n = 12) that simply continued their typical training routine. Knee position sense was assessed at baseline and after the 8-week period (post-testing). One-way analysis of covariance, with baseline performance included as a covariate, was used to compare knee position sense errors for the reconstructed limbs of the experimental and control groups at the post-testing time point.
FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period. As a result, the experimental group demonstrated lower knee position sense errors, compared to the control group, at the post-testing time point (P < .001).
INTERPRETATION


Athletes with a history of anterior cruciate ligament reconstruction may benefit from participation in a neuromuscular training program, even after completing post-operative rehabilitation.",2020,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","['athletes who have undergone anterior cruciate ligament reconstruction', 'Twenty-four male athletes, who had undergone anterior cruciate ligament reconstruction within the previous 6-12\xa0months and returned to sport', 'anterior cruciate ligament reconstruction', 'athletes who have returned to sport following anterior cruciate ligament reconstruction', 'athletes with a history of anterior cruciate ligament reconstruction', 'Athletes with a history of anterior cruciate ligament reconstruction', 'uninjured athletes']","['Neuromuscular training', 'neuromuscular training program', 'Neuromuscular training programs', 'neuromuscular training program or a control group (n\xa0=\xa012) that simply continued their typical training routine']","['lower knee position sense errors', 'knee proprioception', 'Knee position sense errors', 'Knee position sense']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]",24.0,0.0152322,"FINDINGS


Knee position sense errors decreased by 51.7% for the experimental group and only 4.4% for the control group over the 8-week period.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghaderi', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Letafatkar', 'Affiliation': 'Kharazmi University, No. 43, South Mofatteh Ave., Tehran 15719-14911, Iran.'}, {'ForeName': 'Thomas Gus', 'Initials': 'TG', 'LastName': 'Almonroeder', 'Affiliation': 'University of Wisconsin - La Crosse, 1300 Badger St., La Crosse, WI 54601, United States. Electronic address: talmonroeder@uwlax.edu.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Velenjak St., Tehran 19857-17443, Iran.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105157']
1948,32885637,[Comparative study of the efficacy of combined nasal topical drug and topical decongestants in the treatment of acute rhinosinusitis].,"OBJECTIVE


To evaluate the efficacy of the drug Frinozol (nasal spray phenylephrinein 0.25% + cetirizine 0.25%) comparison with Rinostop Extra (nasal spray oxymetazoline 0.05%) in relation to nasal symptoms of rhinosinusitis, evaluated on rating scales, when using these drugs intranasally for 7 days in patients with acute viral and post-viral rhinosinusitis of mild (VAS 0-3) and moderate (VAS 3-7).
PATIENTS AND METHODS


The randomized open-label study included 60 ambulatory patients (men and women aged 18 to 60 years) with a verified diagnosis of acute rhinosinusitis (ARS) lasting no more than 120 hours. 1 group of patients took Frinozol (nasal spray phenylephrinein 0.25% + cetirizine 0.25%) for 2 sprays per each nostril 3 times a day for 7 days; 2 group - Rinostop Extra (nasal spray oxymetazoline 0.05%) at the same dose and the therapy regimen. We evaluated 3 visits (day 1, day 3, and day 7) with an ENT examination on each of them; questionnaires on the 1st and 3rd visits of nasal symptoms (nasal obstruction, rhinorrhea, hyposmia) on the visual analog scale (VAS) and Clinical Global Impression Scale-CGI. Active anterior rhinomanometry (AAR) was performed on the 1st, 2nd and 3rd visits using the PTS-14P-01 rhinomanometer Rinolan before and 20 minutes after the use of the drugs Frinozol and oxymetazoline 0.05%.",2020,"Active anterior rhinomanometry (AAR) was performed on the 1st, 2nd and 3rd visits using the PTS-14P-01 rhinomanometer Rinolan before and 20 minutes after the use of the drugs Frinozol and oxymetazoline 0.05%.","['patients with acute viral and post-viral rhinosinusitis of mild (VAS 0-3) and moderate (VAS 3-7', 'acute rhinosinusitis', '60 ambulatory patients (men and women aged 18 to 60 years) with a verified diagnosis of acute rhinosinusitis (ARS) lasting no more than 120 hours']","['Frinozol (nasal spray phenylephrinein 0.25% + cetirizine', 'combined nasal topical drug and topical decongestants', 'Rinostop Extra (nasal spray oxymetazoline']","['Active anterior rhinomanometry (AAR', 'nasal symptoms (nasal obstruction, rhinorrhea, hyposmia) on the visual analog scale (VAS) and Clinical Global Impression Scale-CGI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0055147', 'cui_str': 'Cetirizine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282374', 'cui_str': 'Decongestant'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}]","[{'cui': 'C0430616', 'cui_str': 'Active anterior rhinomanometry'}, {'cui': 'C0574156', 'cui_str': 'Afar language'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}]",60.0,0.0170217,"Active anterior rhinomanometry (AAR) was performed on the 1st, 2nd and 3rd visits using the PTS-14P-01 rhinomanometer Rinolan before and 20 minutes after the use of the drugs Frinozol and oxymetazoline 0.05%.","[{'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Shakhova', 'Affiliation': 'Volgograd State Medical University, Volgograd, Russia.'}]",Vestnik otorinolaringologii,['10.17116/otorino20208504146']
1949,31829085,Can the fistula arm be used to lift heavy items? Six-pound dumbbells versus handgrip exercise in a 6-month follow-up secondary analysis of a randomized controlled trial.,"INTRODUCTION


Patients with arteriovenous fistulas are advised to avoid carrying heavy objects draped over the fistula arm. Awareness gradually leads to overprotection and a reduction in the use of the fistula arm. However, restricting motion in the fistula arm leads to decreased quality of life and diminished muscle strength. The current safety recommendations regarding lifting heavy items with the fistula arm are primarily based on experience. Few studies have provided evidence clarifying the scope of safe activity and the influence of load bearing on the continued patency of arteriovenous fistulas.
METHODS


This prospective observation was based on a long-term follow-up study in which 86 hemodialysis recipients with arteriovenous fistulas were randomized into either a dumbbell group or a handgrip group. The dumbbell group exercised with 6-lb dumbbells, while the handgrip group squeezed rubber balls. Postintervention primary patency and adverse events at the 6-month follow-up were analyzed.
RESULTS


No significant difference in postintervention primary patency was observed between the dumbbell group and the handgrip group at 6 months (97.4% vs 95.0%). There were two participants with high-flow fistulas in the dumbbell group and three in the handgrip group, with no significant difference between the two groups (5.3% vs 7.5%). In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage.
CONCLUSION


Hemodialysis patients can safely use their fistula arm to lift objects weighing less than 6 lb, which encourages increased motion and helps preserve the functionality of the fistula arm.",2020,"In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage.
","['86 hemodialysis recipients with arteriovenous fistulas', 'Patients with arteriovenous fistulas']","['dumbbell group exercised with 6-lb dumbbells, while the handgrip group squeezed rubber balls', 'handgrip group', 'Six-pound dumbbells versus handgrip exercise']","['high-flow fistulas', 'Postintervention primary patency and adverse events', 'quality of life and diminished muscle strength', 'postintervention primary patency', 'cardiac failure, aneurysm, puncture site hematoma, or hemorrhage']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C4760962', 'cui_str': 'Puncture site haematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",86.0,0.0195124,"In both groups, there were no other adverse events reported regarding cardiac failure, aneurysm, puncture site hematoma, or hemorrhage.
","[{'ForeName': 'Ya-Wen', 'Initials': 'YW', 'LastName': 'Mo', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Jing-Ya', 'Initials': 'JY', 'LastName': 'Huang', 'Affiliation': 'Division of Nephrology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Sun', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Li-Fang', 'Initials': 'LF', 'LastName': 'Zhou', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shu-Qian', 'Initials': 'SQ', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhuang', 'Affiliation': 'Department of Rehabilitation Medicine, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Ying-Gui', 'Initials': 'YG', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Yuan-Han', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shuang-Xin', 'Initials': 'SX', 'LastName': 'Liu', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xin-Ling', 'Initials': 'XL', 'LastName': 'Liang', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}]",The journal of vascular access,['10.1177/1129729819894090']
1950,32887591,Cost-effectiveness of the Namaste care family program for nursing home residents with advanced dementia in comparison with usual care: a cluster-randomized controlled trial.,"BACKGROUND


Dementia is a progressive disease that decreases quality of life of persons with dementia and is associated with high societal costs. The burden of caring for persons with dementia also decreases the quality of life of family caregivers. The objective of this study was to assess the societal cost-effectiveness of Namaste Care Family program in comparison with usual care in nursing home residents with advanced dementia.
METHODS


Nursing homes were randomized to either Namaste Care Family program or usual care. Outcome measures of the cluster-randomized trial in 231 residents included Quality of Life in Late-Stage Dementia (QUALID) and the Gain in Alzheimer Care Instrument (GAIN) for family caregivers over 12 months of follow-up. Health states were measured using the EQ-5D-3L questionnaire which were translated into utilities. QALYs were calculated by multiplying the amount of time a participant spent in a specific health state with the utility score associated with that health state. Healthcare utilization costs were estimated using standard unit costs, while intervention costs were estimated using a bottom-up approach. Missing cost and effect data were imputed using multiple imputation. Bootstrapped multilevel models were used after multiple imputation. Cost-effectiveness acceptability curves were estimated.
RESULTS


The Namaste Care Family program was more effective than usual care in terms of QUALID (- 0.062, 95%CI: - 0.40 to 0.28), QALY (0.0017, 95%CI: - 0.059 to 0.063) and GAIN (0.075, 95%CI: - 0.20 to 0.35). Total societal costs were lower for the Namaste Care Family program as compared to usual care (- 552 €, 95%CI: - 2920 to 1903). However, these differences were not statistically significant. The probability of cost-effectiveness at a ceiling ratio of 0 €/unit of effect extra was 0.70 for the QUALID, QALY and GAIN.
CONCLUSIONS


The Namaste Care Family program is dominant over usual care and, thus, cost-effective, although statistical uncertainty was considerable.
TRIAL REGISTRATION


Netherlands Trial Register ( http://www.trialregister.nl/trialreg/index.asp , identifier: NL5570, date of registration: 2016/03/23).",2020,"Total societal costs were lower for the Namaste Care Family program as compared to usual care (- 552 €, 95%CI: - 2920 to 1903).","['nursing home residents with advanced dementia in comparison with usual care', 'nursing home residents with advanced dementia', '231 residents included', 'persons with dementia', 'Nursing homes']","['Namaste care family program', 'Namaste Care Family program or usual care', 'Namaste Care Family program']","['Healthcare utilization costs', 'probability of cost-effectiveness', 'Cost-effectiveness acceptability curves', 'quality of life of family caregivers', 'Quality of Life in Late-Stage Dementia (QUALID) and the Gain in Alzheimer Care Instrument (GAIN', 'Cost-effectiveness', 'societal cost-effectiveness', 'Total societal costs']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",231.0,0.0769796,"Total societal costs were lower for the Namaste Care Family program as compared to usual care (- 552 €, 95%CI: - 2920 to 1903).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Alili', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke J A', 'Initials': 'HJA', 'LastName': 'Smaling', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Karlijn J', 'Initials': 'KJ', 'LastName': 'Joling', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilco P', 'Initials': 'WP', 'LastName': 'Achterberg', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Anneke L', 'Initials': 'AL', 'LastName': 'Francke', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Jenny T', 'Initials': 'JT', 'LastName': 'van der Steen', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands. jtvandersteen@lumc.nl.'}]",BMC health services research,['10.1186/s12913-020-05570-2']
1951,32887594,Collaborative model of care between Orthopaedics and allied healthcare professionals trial (CONNACT) - a feasibility study in patients with knee osteoarthritis using a mixed method approach.,"BACKGROUND


Osteoarthritis is a leading cause of global disability resulting in significant morbidity and cost to the healthcare system. Current guidelines recommend lifestyle changes such exercises and weight loss as first line treatment prior to surgical consideration. Our current model of care is inefficient with suboptimal allied health intervention for effective behaviour changes. A 12-week community based, individualized, multidisciplinary new model of care for knee osteoarthritis was developed in light of current deficiencies.
METHODS


The primary aim of this study was to determine the feasibility of a full randomized controlled trial evaluating this new model of care using pre-defined progression criteria. The secondary aim was to optimize the intervention and study design through a process evaluation. A pilot exploratory, parallel arm, single blinded randomized trial design using a mixed method approach was utilized. Progression criteria for a full trial including key domains of patient recruitment and retention, outcome measure acceptability and improvement, adverse events were developed. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and 12-weeks. Secondary outcomes included quality of life, functional and psychological assessments. Semi-structured interviews were conducted with the patients at 12-weeks.
RESULTS


20 patients (3 males, 17 females) were randomized (10 intervention, 10 control). Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks. Semi-structured interviews revealed several themes pertaining to feasibility and intervention optimization. 5 out of the 6 progression criteria's domains were met (recruitment criteria not met).
CONCLUSION


This pilot has demonstrated the feasibility of a full randomized control trial investigating the potential effectiveness of the new proposed model of care for knee osteoarthritis using pre-defined progression criteria and process evaluation. Results from the qualitative study were used to modify and improve the intervention content, delivery model and study design for a large effectiveness-implementation hybrid randomized control trial that is currently underway.
TRIAL REGISTRATION


Retrospectively registered on 18 January 2019 at http://clinicaltrial.gov ID: NCT03809975 .",2020,"Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks.","['20 patients (3 males, 17 females', 'patients with knee osteoarthritis using a mixed method approach']",[],"['Knee Injury and Osteoarthritis Outcome Score (KOOS', 'quality of life, functional and psychological assessments', 'knee function, quality of life, psychological outcome, dietary improvement and weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],"[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0204452', 'cui_str': 'Psychological assessment'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.104048,"Intervention arm patients reported better improvements in their knee function, quality of life, psychological outcome, dietary improvement and weight loss compared to the control arm at 12-weeks.","[{'ForeName': 'Bryan Yijia', 'Initials': 'BY', 'LastName': 'Tan', 'Affiliation': 'Department of Orthopaedic Surgery, Woodlands Health Campus, National Healthcare Group, Singapore, Singapore. btanyj@hotmail.com.'}, {'ForeName': 'Benjamin Tze Keong', 'Initials': 'BTK', 'LastName': 'Ding', 'Affiliation': 'Ministry of Health Holdings, Singapore, Singapore.'}, {'ForeName': 'Michelle Jessica', 'Initials': 'MJ', 'LastName': 'Pereira', 'Affiliation': 'Health Services Outcome Research, National Healthcare Group, Singapore, Singapore.'}, {'ForeName': 'Soren Thorgaard', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Thumboo', 'Affiliation': 'Singapore General Hospital, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03611-9']
1952,32887596,Application of Freire's adult education model in modifying the psychological constructs of health belief model in self-medication behaviors of older adults: a randomized controlled trial.,"BACKGROUND


Self-medication by older adults has been always a public health concern. The present study aimed to modify the psychological constructs of Health Belief Model (HBM) in relation to self-medication behaviors using Freire's Adult Education Model (FAEM) among older adults in Khorramabad, Iran, from 2017 to 2018.
METHODS


The mean age of the older adults was 66.28 ± 7.18 years. This was a randomized controlled trial study conducted on 132 individuals older than 60 who were referred from different health care centers. The participants were selected using multistage sampling method and randomly divided into two groups of intervention and control. The data collection instruments included a questionnaire which was designed based on both HBM and self-medication behaviors questionnaire. The phase of adult education model (AEM) was used to modify the psychological constructs of HBM and self-medication behaviors. Data were analyzed using SPSS software version 20 with a significant level of 0.05. Descriptive statistical tests, chi-squared test, paired t-test, independent t-test, and univariate modeling were employed for the purpose of analyzing data.
RESULTS


There was no significant difference between groups in terms of self-medication. Unawareness of the effects of medicine were the most important reason for self-medication (p = 0.50). The two groups were not significantly different in terms of knowledge, HBM constructs, and self-medication behaviors (p > 0.05). However, they came up to be considerably different for the above variables after the intervention was implemented (p <  0.05). When the findings were adjusted for the effects of confounding variables, there were significant differences between the two groups in almost all constructs of HBM and their behaviors (p <  0.05). However, the perceived barrier modality of HBM did not reach to a significant level of difference between two groups.
CONCLUSION


The educational intervention, which was based on Freire's AEM, had positive effects on the constructs of HBM and consequently on self-medication behaviors. The psychological constructs of HBM were affected at the phases of listening to problems. Self-medication was tempered at the action-reflection phase with shared creation and evaluation of the action plan geared toward the achievement of the behavioral objectives. The results might be of importance to healthcare professionals involved in care of older patients.
TRIAL REGISTRATION


Current Controlled Trials IRCT2013091814512N2. Registered on January 2 - prospectively registered, the trial was registered in the Iranian Clinical Trials Registry http://www.irct.ir .",2020,Unawareness of the effects of medicine were the most important reason for self-medication (p = 0.50).,"['older adults', '132 individuals older than 60 who were referred from different health care centers', 'older adults in Khorramabad, Iran, from 2017 to 2018', 'mean age of the older adults was 66.28\u2009±\u20097.18\u2009years']","[""Freire's Adult Education Model (FAEM"", 'Health Belief Model (HBM']","['self-medication', 'knowledge, HBM constructs, and self-medication behaviors', 'HBM and their behaviors']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0424936', 'cui_str': 'Adult education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}]","[{'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",132.0,0.0287915,Unawareness of the effects of medicine were the most important reason for self-medication (p = 0.50).,"[{'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Gharouni', 'Affiliation': 'School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ardalan', 'Affiliation': 'Department of Cancer Registry, Providence Saint Joseph Medical Center, 501 S Buena Vista St, Burbank, CA, 91505, USA.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Araban', 'Affiliation': 'Department of Health Education and Promotion, Public Health School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Ebrahimzadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Katayon', 'Initials': 'K', 'LastName': 'Bakhtiar', 'Affiliation': 'Department of Public Health, School of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Almasian', 'Affiliation': 'School of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bastami', 'Affiliation': 'Department of Public Health, School of Health and Nutrition, Lorestan University of Medical Sciences, Khorramabad, Iran. fatemeh2011bastami@gmail.com.'}]",BMC public health,['10.1186/s12889-020-09425-7']
1953,32887632,Analysis of compliance and efficacy of integrated management of whole process in the choice of percutaneous full-endoscopic surgery for patients with cervical disc herniation.,"BACKGROUND


Percutaneous spinal endoscopy is a new type of surgery for the treatment of cervical disc herniation. It can avoid the complications of the classic anterior cervical discectomy and fusion (ACDF) approach and the risk of adjacent spondylosis. How can we effectively improve patients' awareness of spinal endoscopy and their election of endoscopic techniques?
OBJECTIVE


To analyze the compliance and clinical effect of the integrated management of the whole process in the choice of percutaneous full-endoscopic surgery for patients with cervical disc herniation.
METHODS


Retrospective analysis of 72 patients with cervical disc herniation undergoing surgery in our hospital from August 2015-August 2017 was performed. The whole-process integrated management model was used for all the patients. The 36 patients in the experimental group were treated by percutaneous full-endoscopic cervical discectomy, and the 36 patients in the control group were treated by ACDF. The postoperative feeding time, time to get out of bed, length of hospital stay, compliance, clinical efficacy, and recurrence rate of neck pain were observed. Changes between the preoperative and postoperative pain visual analog scale (VAS) scores and neurological function Japan Orthopaedic Association (JOA) scores were assessed.
RESULTS


The postoperative feeding time in the experimental group was 8.319 ± 1.374 h, the postoperative time to get out of bed was 16.64 ± 3.728 h, and the hospitalization time was 6.403 ± 0.735 days. The excellent and good clinical efficacy rate was 91.67%, the compliance rate was 88.89%, and the neck pain recurrence rate was 5.56%. The postoperative feeding time in the control group was 26.56 ± 9.512 h, the postoperative time to get out of bed was 45.06 ± 9.027 h, and the length of hospital stay was 8.208 ± 0.865 days. The excellent and good clinical efficacy rate was 88.89%, the compliance rate was 69.4%, and the neck pain recurrence rate was 8.33%. There was no significant difference between the two groups in the excellent efficacy rate and the neck pain recurrence rate, p > 0.05. The compliance rate in the experimental group was better than that in the control group, and the difference was statistically significant, p < 0.05. The hospitalization time of the experimental group was significantly lower than that of the control group, and the difference was statistically significant, p < 0.05. The postoperative VAS scores and JOA scores of the two groups were significantly better than the preoperative scores, and the difference was statistically significant, p < 0.05; there was no significant difference between the two groups, p > 0.05.
CONCLUSION


The integrated management of the whole course can effectively improve the compliance of patients with cervical disc herniation receiving endoscopic treatment, yield the same treatment effect as the classic operation, shorten the hospitalization time, speed up the turnover of hospital beds, and improve satisfaction with medical quality and is worthy of clinical application.",2020,"There was no significant difference between the two groups in the excellent efficacy rate and the neck pain recurrence rate, p > 0.05.","['cervical disc herniation', '72 patients with cervical disc herniation undergoing surgery in our hospital from August 2015-August 2017 was performed', 'patients with cervical disc herniation', 'patients with cervical disc herniation receiving endoscopic treatment']","['percutaneous full-endoscopic surgery', 'ACDF', 'Percutaneous spinal endoscopy', 'percutaneous full-endoscopic cervical discectomy']","['postoperative VAS scores and JOA scores', 'postoperative feeding time', 'postoperative feeding time, time to get out of bed, length of hospital stay, compliance, clinical efficacy, and recurrence rate of neck pain', 'excellent efficacy rate and the neck pain recurrence rate', 'excellent and good clinical efficacy rate', 'compliance rate', 'neck pain recurrence rate', 'postoperative time to get out of bed', 'preoperative and postoperative pain visual analog scale (VAS) scores and neurological function Japan Orthopaedic Association (JOA) scores', 'hospitalization time', 'length of hospital stay']","[{'cui': 'C0410619', 'cui_str': 'Prolapsed cervical intervertebral disc'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408598', 'cui_str': 'Excision of cervical intervertebral disc'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",72.0,0.0203633,"There was no significant difference between the two groups in the excellent efficacy rate and the neck pain recurrence rate, p > 0.05.","[{'ForeName': 'Zhongyan', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopedics Surgery, Affiliated Hospital of Zunyi Medical University, No.149 Dalian Road, Zunyi, 563000, Guizhou, China.'}, {'ForeName': 'Ansu', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics Surgery, Affiliated Hospital of Zunyi Medical University, No.149 Dalian Road, Zunyi, 563000, Guizhou, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics Surgery, Affiliated Hospital of Zunyi Medical University, No.149 Dalian Road, Zunyi, 563000, Guizhou, China.'}, {'ForeName': 'Weijun', 'Initials': 'W', 'LastName': 'Kong', 'Affiliation': 'Department of Orthopedics Surgery, Affiliated Hospital of Zunyi Medical University, No.149 Dalian Road, Zunyi, 563000, Guizhou, China. kong0526@sina.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01920-2']
1954,32887873,"Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study.","Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1-3 prior lines of therapy (LoTs). We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. Overall, 646 patients with RRMM and 1-3 prior LoTs were randomized 1:1 to ERd or Rd. PFS and overall response rate were co-primary endpoints. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1-3 prior LoTs. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2-3 prior LoTs.",2020,"ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups.",['646 patients with RRMM and 1-3 prior LoTs'],"['lenalidomide/dexamethasone', 'Elotuzumab, lenalidomide, and dexamethasone', 'elotuzumab plus lenalidomide/dexamethasone (ERd']","['magnitude of OS benefit', 'Prolonging overall survival (OS', 'progression-free survival (PFS', 'PFS and overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1832049', 'cui_str': 'elotuzumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",646.0,0.116092,"ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68-1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups.","[{'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens, Greece. mdimop@med.uoa.gr.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Darrell', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital, Nantes, France.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center of Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada, IDISNA, CIBERONC, Pamplona, Spain.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Shpilberg', 'Affiliation': 'Institute of Haematology, Assuta Medical Centers, Tel Aviv, Israel.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Špička', 'Affiliation': 'Charles University in Prague and General Teaching Hospital, Prague, Czech Republic.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Walter-Croneck', 'Affiliation': 'Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Magen', 'Affiliation': 'Department of Hematology Chaim Sheba Medical Center, Ramat-Gan, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca-Instituto de Investigación Biomédica de Salamanca, Centro de Investigación del Cáncer-IBMCC (USAL-CSIC), Salamanca, Spain.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Belch', 'Affiliation': 'Cross Cancer Institute and University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reece', 'Affiliation': 'Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Oakervee', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Taniwaki', 'Affiliation': 'Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Röllig', 'Affiliation': 'Universitätsklinikum der Technischen Universität, Dresden, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Einsele', 'Affiliation': 'Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Morio', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan.'}, {'ForeName': 'Ka Lung', 'Initials': 'KL', 'LastName': 'Wu', 'Affiliation': 'Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp, Belgium.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Anderson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ying-Ming', 'Initials': 'YM', 'LastName': 'Jou', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ganetsky', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Singhal', 'Affiliation': 'AbbVie Biotherapeutics, Redwood City, CA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Blood cancer journal,['10.1038/s41408-020-00357-4']
1955,32871881,Effects of adductor canal block on pain management compared with epidural analgesia for patients undergoing total knee arthroplasty: A randomized controlled trial protocol.,"BACKGROUND


Total knee arthroplasty (TKA) is known to be a painful orthopedic procedure and moderate to severe pain is common, especially immediately postoperatively and during active motion. The aim of the present study was to compare epidural analgesia (EA) and adductor canal block (ACB) techniques with regard to early period pain levels, need for additional opioids, and ambulation and functional scores in patients who had undergone primary TKA.
METHODS


Approval for the study was granted by the Changji Branch of the First Affiliated Hospital of Xinjiang Medical University. Written informed consent will be obtained from all of the participants. Inclusion criteria included the following: planned unilateral TKA; spinal anesthesia; American Society of Anesthesiologists physical status classification score of I to III. Prospective assessment will be done for 100 patients who are scheduled for unilateral primary TKA surgery in our academic hospital by a single senior surgeon between August 2020 and December 2021. Patients were randomized to ACB treatment or EA treatment by a computer random number generator. The primary outcome was visual analog scale pain scores in the immediate postoperative period. Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion. Results were evaluated in a confidence interval of 95% and at a significance level of P < .05.
CONCLUSIONS


We hypothesized that standard ACB would be as effective as EA for postoperative pain management following TKA.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5775).",2020,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion.","['Approval for the study was granted by the Changji Branch of the First Affiliated Hospital of Xinjiang Medical University', 'patients who had undergone primary TKA', '100 patients who are scheduled for unilateral primary TKA surgery in our academic hospital by a single senior surgeon between August 2020 and December 2021', 'patients undergoing total knee arthroplasty']","['adductor canal block', 'Total knee arthroplasty (TKA', 'ACB treatment or EA', 'standard ACB', 'epidural analgesia', 'epidural analgesia (EA) and adductor canal block (ACB) techniques']","['visual analog scale pain scores', 'postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion', 'pain management']","[{'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.170627,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and knee range of motion.","[{'ForeName': 'Lianzhou', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Changji Branch of the First Affiliated Hospital of Xinjiang Medical University.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Gynaecology and Obstetrics, Changji First People's Hospital.""}, {'ForeName': 'Zhengkai', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Intensive Medicine, Changji Branch of the First Affiliated Hospital of Xinjiang Medical University, Xinjiang, China.'}, {'ForeName': 'Hanjuan', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Changji Branch of the First Affiliated Hospital of Xinjiang Medical University.'}]",Medicine,['10.1097/MD.0000000000021672']
1956,32871238,"""Effect of Calcifediol Treatment and best Available Therapy versus best Available Therapy on Intensive Care Unit Admission and Mortality Among Patients Hospitalized for COVID-19: A Pilot Randomized Clinical study"".","OBJECTIVE


The vitamin D endocrine system may have a variety of actions on cells and tissues involved in COVID-19 progression especially by decreasing the Acute Respiratory Distress Syndrome. Calcifediol can rapidly increase serum 25OHD concentration. We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
DESIGN


parallel pilot randomized open label, double-masked clinical trial.
SETTING


university hospital setting (Reina Sofia University Hospital, Córdoba Spain.) PARTICIPANTS: 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1).
PROCEDURES


All hospitalized patients received as best available therapy the same standard care, (per hospital protocol), of a combination of hydroxychloroquine (400 mg every 12 hours on the first day, and 200 mg every 12 hours for the following 5 days), azithromycin (500 mg orally for 5 days. Eligible patients were allocated at a 2 calcifediol:1 no calcifediol ratio through electronic randomization on the day of admission to take oral calcifediol (0.532 mg), or not. Patients in the calcifediol treatment group continued with oral calcifediol (0.266 mg) on day 3 and 7, and then weekly until discharge or ICU admission. Outcomes of effectiveness included rate of ICU admission and deaths.
RESULTS


Of 50 patients treated with calcifediol, one required admission to the ICU (2%), while of 26 untreated patients, 13 required admission (50%) p value X 2  Fischer test p < 0.001. Univariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment versus without Calcifediol treatment: 0.02 (95%CI 0.002-0.17). Multivariate Risk Estimate Odds Ratio for ICU in patients with Calcifediol treatment vs Without Calcifediol treatment ICU (adjusting by Hypertension and T2DM): 0.03 (95%CI: 0.003-0.25). Of the patients treated with calcifediol, none died, and all were discharged, without complications. The 13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged. Of the 13 patients admitted to the ICU, two died and the remaining 11 were discharged.
CONCLUSION


Our pilot study demonstrated that administration of a high dose of Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine system, significantly reduced the need for ICU treatment of patients requiring hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce severity of the disease, but larger trials with groups properly matched will be required to show a definitive answer.",2020,"We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
","['50 patients treated with', 'patients requiring hospitalization due to proven COVID-19', 'Eligible patients', ' 76 consecutive patients hospitalized with COVID-19 infection, clinical picture of acute respiratory infection, confirmed by a radiographic pattern of viral pneumonia and by a positive SARS-CoV-2 PCR with CURB65 severity scale (recommending hospital admission in case of total score > 1', '13 patients not treated with calcifediol, who were not admitted to the ICU, were discharged', 'All hospitalized patients', 'Spanish patients hospitalized for COVID-19', 'university hospital setting (Reina Sofia University Hospital, Córdoba Spain', 'Patients Hospitalized for COVID-19', '13 patients admitted to the ICU, two died and the remaining 11 were discharged']","['hydroxychloroquine', 'Calcifediol or 25-hydroxyvitamin D', 'azithromycin', 'oral calcifediol', 'Calcifediol', 'calcifediol']","['rate of ICU admission and deaths', 'serum 25OHD concentration', 'Intensive Care Unit Admission and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536597', 'cui_str': 'Patient requires hospitalization'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0238990', 'cui_str': 'Acute lower respiratory tract infection'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0032310', 'cui_str': 'Viral pneumonia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0445270', 'cui_str': 'Sofia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",13.0,0.0691693,"We therefore evaluated the effect of calcifediol treatment, on Intensive Care Unit Admission and Mortality rate among Spanish patients hospitalized for COVID-19.
","[{'ForeName': 'Marta Entrenas', 'Initials': 'ME', 'LastName': 'Castillo', 'Affiliation': 'UGC de Neumología. Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain.'}, {'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Entrenas Costa', 'Affiliation': 'UGC de Neumología. Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain. Electronic address: lmentrenas@uco.es.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vaquero Barrios', 'Affiliation': 'UGC de Neumología. Instituto Maimónides de Investigación Biomédica de Córdoba 9 (IMIBIC). Hospital Universitario Reina Sofía, Universidad de Córdoba, Avda. Menéndez 10 Pidal s/n, 14004 11, Córdoba, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Alcalá Díaz', 'Affiliation': 'Departamento de Medicina Interna. IMIBIC. CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain.'}, {'ForeName': 'José López', 'Initials': 'JL', 'LastName': 'Miranda', 'Affiliation': 'Departamento de Medicina Interna. IMIBIC. CIBER de Fisiopatología de la Obesidad y la Nutrición. Hospital Universitario Reina Sofía, Universidad de Córdoba, Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 14004 14, Córdoba, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bouillon', 'Affiliation': 'Department of Chronic Diseases, Metabolism and Ageing, Laboratory of Clinical and Experimental Endocrinology, KU Leuven, Herestraat, ON1/902, 3000, Leuven, Belgium.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Quesada Gomez', 'Affiliation': 'IMIBIC. CIBER de Fragilidad y Envejecimiento Saludable. Hospital Universitario Reina Sofía. Universidad de Córdoba. Fundación Progreso y Salud. Avda. Menéndez Pidal s/n, 18 14004, Córdoba, Spain.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105751']
1957,32880227,[Effectiveness of stabilization training for adolescent refugees with trauma-induced disorders: A randomized controlled trial].,"Effectiveness of stabilization training for adolescent refugees with trauma-induced disorders: A randomized controlled trial  Abstract.  Unaccompanied minor refugees (UMR) are a group particularly vulnerable to mental illness. They pose a great challenge not only for child and youth psychiatric and psychotherapeutic care, but also for youth-welfare institutions. The study examines the effectiveness of  Stabilization Training for Adolescent Refugees with Trauma Induced Disorders  in inpatient youth-welfare facilities.  Methods:  We conducted a randomized controlled trial with pre-post design in a naturalistic setting, randomly assigning 9 housing groups for UMRs to the intervention or waiting control condition. The mental stress of 46 UMRs was assessed by both self-report and educational staff-report. Two educational staff members conducted the  Stabilization Training for Adolescent Refugees with Trauma Induced Disorders  as an intervention in each of the respective residential groups.  Results:  Participation in training led to a reduction in subjective general psychological stress. At the end of the training, psychological stress in self-judgment was significantly lower in the intervention group than in the waiting control condition. The effectiveness of the training is apparently not reflected by educational staff assessments.  Conclusions:  Stabilization training is a suitable instrument for the preclinical care of UMR and thus an essential basis for further psychotherapy.",2020,"At the end of the training, psychological stress in self-judgment was significantly lower in the intervention group than in the waiting control condition.","['Adolescent Refugees with Trauma Induced Disorders  as an intervention in each of the respective residential groups', 'adolescent refugees with trauma-induced disorders', 'Adolescent Refugees with Trauma Induced Disorders  in inpatient youth-welfare facilities']","['stabilization training', 'Stabilization training', 'Unaccompanied minor refugees (UMR', 'Stabilization Training']","['subjective general psychological stress', 'psychological stress in self-judgment']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0037440', 'cui_str': 'Social services'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}]",46.0,0.0258952,"At the end of the training, psychological stress in self-judgment was significantly lower in the intervention group than in the waiting control condition.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Walg', 'Affiliation': 'Zentrum für seelische Gesundheit des Kindes- und Jugendalters, Sana-Klinikum Remscheid.'}, {'ForeName': 'Johanna Sophie', 'Initials': 'JS', 'LastName': 'Angern', 'Affiliation': 'Zentrum für seelische Gesundheit des Kindes- und Jugendalters, Sana-Klinikum Remscheid.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Michalak', 'Affiliation': 'Department für Psychologie und Psychotherapie, Universität Witten/Herdecke.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hapfelmeier', 'Affiliation': 'Zentrum für seelische Gesundheit des Kindes- und Jugendalters, Sana-Klinikum Remscheid.'}]",Zeitschrift fur Kinder- und Jugendpsychiatrie und Psychotherapie,['10.1024/1422-4917/a000749']
1958,32881148,The effect of desire thinking on facilitating beliefs in alcohol use disorder: An experimental investigation.,Permissive beliefs relate to the acceptability of engaging in alcohol use in spite of obvious potential negative consequences. They are considered the most proximal and precipitating cognitive factor in the decision to use alcohol and/or the activation of strategies to obtain it. Recent research suggested that 'desire thinking' may be involved in the escalation of craving and addictive behaviours and can play a role in strengthening permissive beliefs. The current study tested whether the induction of desire thinking would have a stronger effect on rate of conviction in permissive beliefs compared to a control cognitive response in the form of neutral thinking and whether this effect would be specific for patients with alcohol use disorder (AUD). Thirty AUD patients and 30 social drinkers (SD) were randomly allocated to two thinking manipulation tasks (desire thinking and neutral thinking). Current permissive beliefs were measured before and after manipulation and after a resting phase. Findings showed that desire thinking increased the level of current permissive beliefs after manipulation relative to the neutral thinking condition for the AUD group but not for the SD group. This effect was not purely dependent on the concurrent level of perceived craving. This study supports a causal relationship between the induction of desire thinking and rate of conviction in permissive beliefs and highlights the relevance of targeting desire thinking in the treatment for AUD patients.,2020,The current study tested whether the induction of desire thinking would have a stronger effect on rate of conviction in permissive beliefs compared to a control cognitive response in the form of neutral thinking; and whether this effect would be specific for patients with Alcohol Use Disorder (AUD).,"['AUD patients', 'Thirty AUD patients and 30 social drinkers (SD', 'patients with Alcohol Use Disorder (AUD', 'Alcohol Use Disorder']","['desire thinking', 'thinking manipulation tasks (desire thinking and neutral thinking']",[],"[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],30.0,0.0340491,The current study tested whether the induction of desire thinking would have a stronger effect on rate of conviction in permissive beliefs compared to a control cognitive response in the form of neutral thinking; and whether this effect would be specific for patients with Alcohol Use Disorder (AUD).,"[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Caselli', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Gemelli', 'Affiliation': 'Studi Cognitivi, Modena, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Studi Cognitivi, Modena, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Beltrami', 'Affiliation': 'Studi Cognitivi, Modena, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Offredi', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Giovanni M', 'Initials': 'GM', 'LastName': 'Ruggiero', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sassaroli', 'Affiliation': 'Studi Cognitivi, Milan, Italy.'}, {'ForeName': 'Marcantonio M', 'Initials': 'MM', 'LastName': 'Spada', 'Affiliation': 'Centre for Addictive Behaviours Research, School of Applied Sciences, London South Bank University, London, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2511']
1959,32877425,Gamification as an approach to improve resilience and reduce attrition in mobile mental health interventions: A randomized controlled trial.,"Forty percent of all general-practitioner appointments are related to mental illness, although less than 35% of individuals have access to therapy and psychological care, indicating a pressing need for accessible and affordable therapy tools. The ubiquity of smartphones offers a delivery platform for such tools. Previous research suggests that gamification-turning intervention content into a game format-could increase engagement with prevention and early-stage mobile interventions. This study aimed to explore the effects of a gamified mobile mental health intervention on improvements in resilience, in comparison with active and inactive control conditions. Differences between conditions on changes in personal growth, anxiety and psychological wellbeing, as well as differences in attrition rates, were also assessed. The eQuoo app was developed and published on all leading mobile platforms. The app educates users about psychological concepts including emotional bids, generalization, and reciprocity through psychoeducation, storytelling, and gamification. In total, 358 participants completed in a 5-week, 3-armed (eQuoo, ""treatment as usual"" cognitive behavioral therapy journal app, no-intervention waitlist) randomized controlled trial. Relevant scales were administered to all participants on days 1, 17, and 35. Repeated-measures ANOVA revealed statistically significant increases in resilience in the test group compared with both control groups over 5 weeks. The app also significantly increased personal growth, positive relations with others, and anxiety. With 90% adherence, eQuoo retained 21% more participants than the control or waitlist groups. Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions. Mobile apps using gamification can be a valuable and effective platform for well-being and mental health interventions and may enhance motivation and reduce attrition. Future research should measure eQuoo's effect on anxiety with a more sensitive tool and examine the impact of eQuoo on a clinical population.",2020,Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions.,"['mobile mental health interventions', '358 participants completed in a 5-week, 3-armed (eQuoo, ""treatment as usual"" cognitive behavioral therapy journal app, no-intervention waitlist) randomized controlled trial']",['gamified mobile mental health intervention'],"['personal growth, anxiety and psychological wellbeing', 'resilience', 'personal growth, positive relations with others, and anxiety', 'attrition rates']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",358.0,0.122714,Intervention delivered via eQuoo significantly raised mental well-being and decreased self-reported anxiety while enhancing adherence in comparison with the control conditions.,"[{'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Litvin', 'Affiliation': 'Department of General Psychology II (Emotion and Motivation), Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Saunders', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, Centre for Outcomes Research and Effectiveness, University College London, London, United Kingdom.'}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Maier', 'Affiliation': 'Department of General Psychology II (Emotion and Motivation), Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lüttke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0237220']
1960,32877581,Weight Loss in Underserved Patients - A Cluster-Randomized Trial.,"BACKGROUND


Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking.
METHODS


We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months.
RESULTS


All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events.
CONCLUSIONS


A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).",2020,"The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001).","['All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic', '803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000', 'primary care clinics in which a high percentage of the patients were from low-income populations']","['high-intensity, lifestyle-based program', 'high-intensity program delivered by health coaches embedded in the clinics', 'standard care from their primary care team', 'intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care']","['weight loss', 'percent change from baseline in body weight', 'Weight Loss', 'percent weight loss', 'serious adverse events']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0024045', 'cui_str': 'Low Income Population'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",803.0,0.0935421,"The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001).","[{'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Katzmarzyk', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Newton', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Eboni G', 'Initials': 'EG', 'LastName': 'Price-Haywood', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Kara D', 'Initials': 'KD', 'LastName': 'Denstel', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Mire', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Tina K', 'Initials': 'TK', 'LastName': 'Thethi', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Phillip J', 'Initials': 'PJ', 'LastName': 'Brantley', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gugel', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Kathleen B', 'Initials': 'KB', 'LastName': 'Kennedy', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Lavie', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Sarpong', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Springgate', 'Affiliation': 'From the Pennington Biomedical Research Center, Baton Rouge (P.T.K., C.K.M., R.L.N., J.W.A., K.D.D., E.F.M., P.J.B., W.D.J.), the Department of Medicine and Feist-Weiller Cancer Center, Louisiana State University Health Sciences Center, Shreveport (C.L.A., T.C.D.), and Ochsner Clinic Foundation, Center for Outcomes and Health Services Research (E.G.P.-H.) and Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute (C.J.L.), Ochsner Clinical School-University of Queensland School of Medicine (E.G.P.-H., C.J.L.), the Department of Medicine, Division of Endocrinology and Metabolism (T.K.T., V.F.) and the Department of Medicine, Section of General Internal Medicine and Geriatrics (J.G.), Tulane University Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System (T.K.T., V.F.), the College of Pharmacy, Xavier University of Louisiana (K.B.K., D.F.S.), and the Department of Internal Medicine, Louisiana State University School of Medicine, and Program in Health Policy and Systems Management, Louisiana State University School of Public Health (B.S.), New Orleans - all in Louisiana.'}]",The New England journal of medicine,['10.1056/NEJMoa2007448']
1961,32877722,Characteristics of contents in the upper gastrointestinal lumen after a standard high-calorie high-fat meal and implications for the in vitro drug product performance testing conditions.,"OBJECTIVES


To measure the pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen after a standard high-calorie, high-fat meal as well as the osmolality, lipid content and bile acid content in the aqueous phase of the gastric contents and the micellar phase of contents of the upper small intestine. To evaluate the implications of these findings for the composition of biorelevant media employed in vitro oral drug product performance testing representing the upper GI conditions after ingestion of the standard meal.
METHODS


Eight healthy male adult volunteers participated in a two-phase, crossover study in which a homogenized standard meal was administered to the antrum via the gastric port of a naso-gastro-intestinal tube. A glass of tap water and single paracetamol and danazol doses were administered to the antrum of the stomach 30 min after the initiation of meal administration (Pentafragka et al., 2020). Samples were aspirated from the antrum and the upper small intestine over the next four hours. The pH and the buffer capacity of the samples were measured immediately upon aspiration, while viscosity, osmolality, and presence of solubilizing agents were measured after storage at -70 °C.
RESULTS


The composition of gastric contents over time fluctuated less after the homogenized standard meal than after liquid meals with similar composition. Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low. Mean viscosity values in the stomach at 100 s -1  were 80-800 times higher than in the fasted state for more than 3 h after the standard meal. In the upper small intestine, mean viscosity values at 100 s -1  were at least 100 times higher than in the fasted state for 4 h after the standard meal.
CONCLUSIONS


Based on data collected in this study, Level I and Level II biorelevant media simulating the intragastric conditions after ingestion of a standard meal could be simplified whereas FeSSIF-V2 composition was confirmed to be representative of the composition of contents in the upper small intestine. Representative values of viscosity in the stomach and the upper small intestine and Level II composition of the aqueous phase of gastric contents, after the standard meal, are proposed for first time.",2020,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,['Eight healthy male adult volunteers'],"['homogenized standard meal', 'paracetamol and danazol']","['Mean viscosity values', 'mean viscosity values', 'viscosity, osmolality, and presence of solubilizing agents', 'pH, buffer capacity, lipid content, bile acid content, and viscosity in the upper gastrointestinal (GI) lumen']","[{'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0444664', 'cui_str': 'Standard meal'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}]",8.0,0.0385476,Intra-subject variability of pH and buffer capacity in the stomach and in the upper small intestine was low.,"[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Pentafragka', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dressman', 'Affiliation': 'Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Symillides', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Goumas', 'Affiliation': 'Department of Gastroenterology, Red Cross Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 15784 Zografou, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105535']
1962,32877791,"Parents as Teachers: Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran.","BACKGROUND


Parents play an important role in protecting their children from sexual abuse. Mothers, in particular, play key roles in the sexual socialization of their children and in educating their children about child sexual abuse (CSA).
OBJECTIVES


The purpose of this study was to determine whether preschool girls in Gorgan (a city in northern Iran) could learn personal safety skills when taught by their mothers.
PARTICIPANTS AND SETTING


Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers. Mean age of girls was 6.34 years.
METHODS


Girls were pretested using Persian versions of the Personal Safety Questionnaire and 'What If' Situations Test, randomly assigned to either a mother-taught program or wait-list control, and post-tested. Mothers assigned to the education group participated in a two-hour workshop on preventing CSA and were given the Body Safety Training workbook to teach their daughters. Following the one-week training by their mothers, children in both groups were post-tested and follow-up tested one month later.
RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
CONCLUSION


Results suggest that mothers can effectively teach their young daughters personal safety skills. Difficulties female children have in recognizing appropriate-touch requests are discussed and compared to results in other developing countries. Advantages of home-based instruction for young children are described and suggestions for increasing parent participation are offered.",2020,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[""Mothers' Roles in Sexual Abuse Prevention Education in Gorgan, Iran"", 'Mean age of girls was 6.34 years', 'Difficulties female children', 'Fifty-six participants (mother-daughter pairs) were recruited from patients visiting health centers', 'young children', 'Parents as Teachers', 'Girls', 'preschool girls in Gorgan (a city in northern Iran']","['home-based instruction', 'mother-taught program or wait-list control, and post-tested']",['knowledge about sexual abuse and higher levels of personal safety skills'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0011011', 'cui_str': 'Daughter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",56.0,0.0148705,"RESULTS


Children taught by their mothers demonstrated significant increases in knowledge about sexual abuse and higher levels of personal safety skills compared to controls, and these gains were maintained at the one-month follow-up.
","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Khoori', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: elhamkhoori@yahoo.com.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Gholamfarkhani', 'Affiliation': 'Department of Obstetrics and Gynecology, Shohada Hospital of Quchan, Mashhad University of Medical Sciences, Quchan, Iran. Electronic address: somayeh.farkhani@gmail.com.'}, {'ForeName': 'Mahin', 'Initials': 'M', 'LastName': 'Tatari', 'Affiliation': 'Counselling and Reproductive Health Research Centre, Golestan University of Medical Sciences, Gorgan, Iran. Electronic address: maisa.tatari@yahoo.com.'}, {'ForeName': 'Sandy K', 'Initials': 'SK', 'LastName': 'Wurtele', 'Affiliation': 'Department of Psychology, University of Colorado, Colorado Springs, USA. Electronic address: swurtele@uccs.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104695']
1963,32877795,Recurrence patterns after neoadjuvant chemoradiotherapy compared with surgery alone in oesophageal squamous cell carcinoma: results from the multicenter phase III trial NEOCRTEC5010.,"BACKGROUND


The aim of this study was to compare recurrence patterns and prognostic factors for developing recurrences in patients with oesophageal squamous cell carcinoma (ESCC) who received neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone from a multicenter phase III trial NEOCRTEC5010.
PATIENTS AND METHODS


Patients with locally advanced ESCC were randomly assigned in a 1:1 ratio to receive neoadjuvant CRT plus surgery (CRT + S group) or surgery alone (S group). CRT consisted of two cycles of vinorelbine and cisplatin with concurrent radiotherapy of 40.0 Gy in 20 fractions. Recurrence patterns, sites, frequency, and timing and potential prognostic factors were compared.
RESULTS


Of the 451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed. After a median follow-up of 51.9 months, 62 patients (33.7%) in the CRT + S group versus 104 patients (45.8%) in the S group experienced recurrences (P = 0.013). The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group. Recurrences occurred earlier in the S group (P = 0.053), and late relapses were much more frequent in the CRT + S group (P = 0.029). On multivariate analysis, R1 resection and surgery alone were adverse factors for developing locoregional recurrences, whereas R1 resection was the only independent factor associated with distant metastases.
CONCLUSIONS


The neoadjuvant CRT regimen was associated with significantly reduced locoregional and distant recurrences compared with surgery alone. Recurrence patterns, sites and frequency were different between groups. TRIAL REGISTRATION CLINICALTRIALS.
GOV IDENTIFIER


NCT01216527.",2020,The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group.,"['patients with oesophageal squamous cell carcinoma (ESCC', '451 patients enrolled from 2007 to 2014, 411 patients who underwent resection were analysed', 'oesophageal squamous cell carcinoma', 'Patients with locally advanced ESCC']","['neoadjuvant chemoradiotherapy', 'vinorelbine and cisplatin with concurrent radiotherapy', 'neoadjuvant chemoradiotherapy (CRT) followed by surgery or surgery alone', 'surgery alone', 'neoadjuvant CRT plus surgery (CRT\xa0+\xa0S group) or surgery alone']","['favourable distant metastasis-free survival', 'locoregional failure-free survival', 'recurrences', 'Recurrences', 'Recurrence patterns, sites, frequency, and timing and potential prognostic factors', 'Recurrence patterns, sites\xa0and frequency', 'Recurrence patterns', 'late relapses', 'locoregional and distant recurrences']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0443203', 'cui_str': 'Distant'}]",451.0,0.126553,The CRT + S group demonstrated a significantly better locoregional failure-free survival (P = 0.012) and a more favourable distant metastasis-free survival (P = 0.028) than the S group.,"[{'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiaoqiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Cancer Hospital of Shantou University Medical College, Shantou, China.'}, {'ForeName': 'Chengchu', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Thoracic Surgery, Taizhou Hospital, Wenzhou Medical University, Linhai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Thoracic Surgery, Tianjin Medical University Cancer Hospital, Tianjin, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jiaqing', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Thoracic Surgery, Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Mengzhong', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Thoracic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: fujh@sysucc.org.cn.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Xi', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangdong Esophageal Cancer Institute, Guangzhou, China; Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: ximian@sysucc.org.cn.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.002']
1964,32877825,Psychomotor Retardation and the prognosis of antidepressant treatment in patients with unipolar Psychotic Depression.,"BACKGROUND


Psychomotor Retardation is a key symptom of Major Depressive Disorder. According to the literature its presence may affect the prognosis of treatment. Aim of the present study is to investigate the prognostic role of Psychomotor Retardation in patients with unipolar Psychotic Depression who are under antidepressant treatment.
METHODS


The Salpetriere Retardation Rating Scale was administered at baseline and after 6 weeks to 122 patients with unipolar Psychotic Depression who were randomly allocated to treatment with imipramine, venlafaxine or venlafaxine plus quetiapine. We studied the effects of Psychomotor Retardation on both depression and psychosis related outcome measures.
RESULTS


73% of the patients had Psychomotor Retardation at baseline against 35% after six weeks of treatment. The presence of Psychomotor Retardation predicted lower depression remission rates in addition to a higher persistence of delusions. After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
CONCLUSIONS


Our data confirm that Psychomotor Retardation is a severity marker of unipolar Psychotic Depression. It is highly prevalent and predicts lower effectivity of antidepressant psychopharmacological treatment.",2020,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","['patients with unipolar Psychotic Depression', 'patients with unipolar Psychotic Depression who are under antidepressant treatment', '122 patients with unipolar Psychotic Depression']","['imipramine', 'imipramine, venlafaxine or venlafaxine plus quetiapine', 'venlafaxine']","['depression remission rates', 'Salpetriere Retardation Rating Scale', 'Psychomotor Retardation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0020934', 'cui_str': 'Imipramine'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0025362', 'cui_str': 'Mental retardation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}]",122.0,0.0264904,"After six weeks of treatment, venlafaxine was associated with higher levels of Psychomotor Retardation compared to imipramine and venlafaxine plus quetiapine.
","[{'ForeName': 'Joost G E', 'Initials': 'JGE', 'LastName': 'Janzing', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands. Electronic address: Joost.Janzing@radboudumc.nl.'}, {'ForeName': 'Tom K', 'Initials': 'TK', 'LastName': 'Birkenhäger', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Walter W', 'Initials': 'WW', 'LastName': 'van den Broek', 'Affiliation': 'Department of Psychiatry Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Leonie M T', 'Initials': 'LMT', 'LastName': 'Breteler', 'Affiliation': 'Department of Psychiatry, St. Antonius-Mesos Hospital, Utrecht, the Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Nolen', 'Affiliation': 'Department of Psychiatry, University Medical Center Groningen, the Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Department of Psychiatry, Radboudumc, Nijmegen, the Netherlands.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.020']
1965,32877859,The influence of center line width during the crossover hop test.,"OBJECTIVES


To assess the influence of center line width on crossover hop for distance test (XHOP) performance.
DESIGN


Repeated measures.
SETTING


University laboratory.
PARTICIPANTS


33 physically active females without history of a ligamentous knee injury (age: 22.5 ± 2.3 years).
MAIN OUTCOME MEASURES


Hop distance was measured during four XHOP conditions with variations in center line width: 2.54 cm (narrow), 15 cm (standard), 12.5% of the participants' height (HT1), and 25% of the participants' height (HT2). A repeated measures ANOVA was used to evaluate differences in hop distance for XHOP condition (narrow, standard, HT1, and HT2).
RESULTS


Differences in hop distance were shown on XHOP condition (p < 0.001). Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
CONCLUSIONS


No differences in hop distance were identified between narrow and standard center line width XHOP conditions in healthy females. Decreased hop distance was shown when center line width was normalized to 25% of participant height in comparison to all other XHOP conditions, with medium effect sizes. This study highlights hop distance outcomes based on different XHOP center line widths, normalizing the XHOP according to height, and potential implications for frontal plane knee loading during the XHOP in healthy individuals.",2020,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","['33 physically active females without history of a ligamentous knee injury (age: 22.5\xa0±\xa02.3 years', 'healthy females', 'University laboratory', 'healthy individuals']",[],"['distance test (XHOP) performance', 'XHOP condition', 'XHOP condition (narrow, standard, HT1, and HT2']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C4517649', 'cui_str': '22.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450565', 'cui_str': 'HT1'}, {'cui': 'C0450566', 'cui_str': 'HT2'}]",33.0,0.0332208,"Post hoc tests identified differences in hop distance between narrow and HT2 (p < 0.001, Effect size (ES) = 0.78), standard and HT2 (p < 0.001, ES = 0.57), and HT1 and HT2 (p < 0.001, ES = 0.58) conditions, respectively.
","[{'ForeName': 'Brandon M', 'Initials': 'BM', 'LastName': 'Ness', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA; Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, 136 Harrison Ave, Boston, MA, 02111, USA. Electronic address: Brandon.Ness@tufts.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Albright', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ehlers', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Glasoe', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Shanna', 'Initials': 'S', 'LastName': 'Selby', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Zimney', 'Affiliation': 'Department of Physical Therapy, University of South Dakota, 414 E Clark Street, Vermillion, SD, 57069, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kernozek', 'Affiliation': 'Department of Health Professions, Physical Therapy Program, La Crosse Institute for Movement Science, University of Wisconsin - La Crosse, 1725 State Street, La Crosse, WI, 54601, USA.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.08.005']
1966,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND


Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS


In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS


We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS


This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
1967,32889091,A novel CNN algorithm for pathological complete response prediction using an I-SPY TRIAL breast MRI database.,"PURPOSE


To apply our convolutional neural network (CNN) algorithm to predict neoadjuvant chemotherapy (NAC) response using the I-SPY TRIAL breast MRI dataset.
METHODS


From the I-SPY TRIAL breast MRI database, 131 patients from 9 institutions were successfully downloaded for analysis. First post-contrast MRI images were used for 3D segmentation using 3D slicer. Our CNN was implemented entirely of 3 × 3 convolutional kernels and linear layers. The convolutional kernels consisted of 6 residual layers, totaling 12 convolutional layers. Dropout with a 0.5 keep probability and L2 normalization was utilized. Training was implemented by using the Adam optimizer. A 5-fold cross validation was used for performance evaluation. Software code was written in Python using the TensorFlow module on a Linux workstation with one NVidia Titan X GPU.
RESULTS


Of 131 patients, 40 patients achieved pCR following NAC (group 1) and 91 patients did not achieve pCR following NAC (group 2). Diagnostic accuracy of our CNN two classification model distinguishing patients with pCR vs non-pCR was 72.5 (SD ± 8.4), with sensitivity 65.5% (SD ± 28.1) and specificity of 78.9% (SD ± 15.2). The area under a ROC Curve (AUC) was 0.72 (SD ± 0.08).
CONCLUSION


It is feasible to use our CNN algorithm to predict NAC response in patients using a multi-institution dataset.",2020,"To apply our convolutional neural network (CNN) algorithm to predict neoadjuvant chemotherapy (NAC) response using the I-SPY TRIAL breast MRI dataset.
","['131 patients', '131 patients from 9 institutions were successfully downloaded for analysis']",['NAC'],"['area under a ROC Curve (AUC', 'Diagnostic accuracy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",131.0,0.036975,"To apply our convolutional neural network (CNN) algorithm to predict neoadjuvant chemotherapy (NAC) response using the I-SPY TRIAL breast MRI dataset.
","[{'ForeName': 'Michael Z', 'Initials': 'MZ', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Physics, Columbia University Medical Center, 177 Ft. Washington Ave., Milstein Bldg Room 3-124B, New York, NY, United States of America. Electronic address: mzl2104@cumc.columbia.edu.'}, {'ForeName': 'Simukayi', 'Initials': 'S', 'LastName': 'Mutasa', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, 622 West 168th Street, PB-1-301, New York, NY, United States of America. Electronic address: stm9116@nyp.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Chang', 'Affiliation': 'Department of Radiological Sciences, Center for Artificial Intelligence in Diagnostic Medicine (CAIDM), University of California, Irvine, Calit2 Building, Suite 4500, 4100 E. Peltason Drive, Irvine, CA, United States of America. Electronic address: changp6@uci.edu.'}, {'ForeName': 'Maham', 'Initials': 'M', 'LastName': 'Siddique', 'Affiliation': 'Department of Radiology, Columbia University Medical Center, 622 West 168th Street, PB-1-301, New York, NY, United States of America. Electronic address: ms5270@cumc.columbia.edu.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Jambawalikar', 'Affiliation': 'Department of Medical Physics, Columbia University Medical Center, 177 Ft. Washington Ave., Milstein Bldg Room 3-124B, New York, NY, United States of America. Electronic address: sj2532@cumc.columbia.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ha', 'Affiliation': 'Breast Imaging Section, New York Presbyterian Hospital, Columbia University Medical Center, 622 West 168th Street, PB-1-301, New York, NY 10032, United States of America. Electronic address: rh2616@columbia.edu.'}]",Magnetic resonance imaging,['10.1016/j.mri.2020.08.021']
1968,32889444,Evaluating substance use treatment efficacy for younger and older adults.,"The purpose of this study was to examine the differential efficacy of aftercare substance use treatments for younger (below 40, n = 107) versus older (40+, n = 114) adults (N = 221), using data from a randomized controlled trial in a community-based substance abuse treatment center. The younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1. Primary outcomes were rates of abstinence and percent use days at 1-year follow-up. Outcomes were compared between standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU). Results showed significant differences by treatment in the older, but not in younger, subsample of participants. Specifically, the older participants in MBRP had significantly higher abstinence rates compared with those in TAU. Further, the older individuals in MBRP had a significantly lower percent of days on which they used compared with those in TAU and RP. Overall, findings suggest that age group may impact aftercare treatment substance use outcomes.",2020,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","['younger adult sample had a mean age of 28.9 while the older adult sample had a mean age of 48.1', 'younger (below 40, n\xa0=\xa0107) versus older (40+, n\xa0=\xa0114) adults (N\xa0=\xa0221), using data from a randomized controlled trial in a community-based substance abuse treatment center', 'younger and older adults']",['aftercare substance'],"['rates of abstinence and percent use days at 1-year follow-up', 'abstinence rates', 'standard cognitive behavioral relapse prevention (RP), Mindfulness-Based Relapse Prevention (MBRP), and 12-step-based treatment as usual (TAU']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079256', 'cui_str': 'Substance abuse treatment center'}]","[{'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",114.0,0.101879,"Results showed significant differences by treatment in the older, but not in younger, subsample of participants.","[{'ForeName': 'Tyree', 'Initials': 'T', 'LastName': 'Dingle', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States. Electronic address: ding7624@pacificu.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106618']
1969,32889451,Episodic future thinking reduces chronic pain severity: A proof of concept study.,"BACKGROUND


Chronic pain is a major public health challenge in the United States and around the world. Current treatments including opioid analgesics and cognitive behavioral therapy possess harmful side effects or limited efficacy, respectively. Chronic pain is associated with a variety of unhealthy behaviors including opioid misuse. Moreover, individuals who suffer from chronic pain exhibit excessive discounting of delayed rewards, suggesting a constricted temporal window of valuation. Reductions in the excessive discounting of delayed rewards has been achieved with Episodic Future Thinking (EFT; vividly imagining realistic future events). EFT has also been associated with reductions in a variety of unhealthy behaviors. In this study, the effects of EFT on delay discounting and levels of pain were investigated in individuals reporting chronic pain.
METHODS


Individuals reporting chronic pain (N = 250; 42.4 % female) were recruited through the Amazon Mechanical Turk platform. Measures of delay discounting and pain were collected at baseline and again after randomization to EFT (N = 128) or Control Episodic Thinking (CET) (N = 122).
RESULTS


EFT significantly reduced delay discounting relative to baseline (p < 0.001) and EFT reduced pain scores in a baseline dependent manner (p = 0.001) when compared to CET; that is, those with the greatest reports of pain experienced the greatest reduction. Furthermore the reduction in delay discounting fully mediated the reduction in pain.
CONCLUSIONS


These findings suggest that Episodic Future Thinking, by widening the temporal window, may reduce pain in those reporting chronic pain and therefore represents a potential novel therapeutic.",2020,"RESULTS


EFT significantly reduced delay discounting relative to baseline (p < 0.001) and EFT reduced pain scores in a baseline dependent manner (p = 0.001) when compared to CET; that is, those with the greatest reports of pain experienced the greatest reduction.","['individuals reporting chronic pain', 'Individuals reporting chronic pain (N = 250; 42.4 % female']","['EFT', 'Control Episodic Thinking (CET', 'Episodic future thinking', 'opioid analgesics and cognitive behavioral therapy']","['EFT reduced pain scores', 'Chronic pain', 'delay discounting and levels of pain', 'delay discounting and pain', 'chronic pain severity', 'pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.120371,"RESULTS


EFT significantly reduced delay discounting relative to baseline (p < 0.001) and EFT reduced pain scores in a baseline dependent manner (p = 0.001) when compared to CET; that is, those with the greatest reports of pain experienced the greatest reduction.","[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Craft', 'Affiliation': 'Center for Transformative Research on Health Behaviors, 1 Riverside Circle, Roanoke, VA 24016, United States; Graduate Program in Translational Biology, Medicine, and Health, Virginia Tech, 1 Riverside Circle, Roanoke, VA 24016, United States; Fralin Biomedical Research Institute at VTC, 2 Riverside Circle, Roanoke, VA 24016, United States.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Tegge', 'Affiliation': 'Center for Transformative Research on Health Behaviors, 1 Riverside Circle, Roanoke, VA 24016, United States; Department of Statistics, Virginia Tech, Blacksburg, VA 24061, United States.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Center for Transformative Research on Health Behaviors, 1 Riverside Circle, Roanoke, VA 24016, United States; Fralin Biomedical Research Institute at VTC, 2 Riverside Circle, Roanoke, VA 24016, United States. Electronic address: wkbickel@vtc.vt.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108250']
1970,32889494,"The closer you feel, the more you care: Positive associations between closeness, pain intensity rating, empathic concern and personal distress to someone in pain.","Previous research revealed inconsistent findings regarding affective responses when facing someone in pain (i.e., empathic concern and/or personal distress). In this paper, we suggest that the degree of closeness between the observer and the person in pain may account for these contradictory results, such that greater closeness towards this person leads to higher personal distress. To test this hypothesis, we induced either low or high closeness with a confederate in 69 randomly assigned participants. Following the closeness induction, participants evaluated their affective responses (empathic concern and personal distress) and rated the confederate's pain intensity after watching the confederate undergoing a painful cold pressure task. Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress. This study thus suggests that closeness is associated with higher cognitive and affective responses to a person in pain.",2020,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.",['69 randomly assigned participants'],['confederate undergoing a painful cold pressure task'],"[""affective responses (empathic concern and personal distress) and rated the confederate's pain intensity"", 'pain intensity rating, empathic concern and personal distress to someone in pain', 'pain intensity rating, empathic concern and personal distress']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0551593,"Results showed that, despite the non-significant effect of closeness induction, closeness across both conditions (low and high) was positively correlated with pain intensity rating, empathic concern and personal distress.","[{'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Grynberg', 'Affiliation': 'Univ. Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, F-59000 Lille, France; Institut Universitaire de France, Paris, France. Electronic address: Delphine.Grynberg@univ-lille.fr.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Konrath', 'Affiliation': 'Lilly Family School of Philanthropy, Indiana University, Indianapolis, IN 46202, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103175']
1971,31826815,Short-term parent reported recovery following open and laparoscopic fundoplication.,"BACKGROUND


It is assumed that children recover faster after laparoscopic (LF) than after open fundoplication (OF). As this has not been confirmed in any randomized study (RCT), we have in a subsection of a larger RCT compared parent reported recovery of children after LF and OF.
METHODS


Postoperative symptoms, use of analgesics, overall well-being, and time to return to school/day-care were recorded in a subsection of children enrolled in a RCT comparing LF and OF. Ethical approval and parental consent were obtained.
RESULTS


Fifty-five children (LF: n = 27, OF: n = 28) of the 88 enrolled in the RCT, were included in the short term follow up on parent reported recovery. Caregivers were interviewed median 28 days [interquartile range (IQR) 22-36] postoperatively. There was no significant difference regarding improvement in overall well-being (LF: 63%, OF: 68%, p = 0.70), new-onset dysphagia (LF: 30%, OF: 18%, p = 0.08), use of analgesics (LF: 15%, OF: 14%, p = 1.00), or time to return to school/day-care (LF: median 7 days [IQR 5-14] vs. OF: 12 days [IQR 7-15], p = 0.35).
CONCLUSION


We could not demonstrate faster recovery after LF than after OF. Most children had returned to school/day-care after 2 weeks and had improved overall well-being 1 month after surgery.
TYPE OF STUDY


Randomized controlled trial.
LEVEL OF EVIDENCE


Level II.",2020,"There was no significant difference regarding improvement in overall well-being (LF: 63%, OF: 68%, p = 0.70), new-onset dysphagia (LF: 30%, OF: 18%, p = 0.08), use of analgesics (LF: 15%, OF: 14%, p = 1.00), or time to return to school/day-care (LF: median 7 days [IQR 5-14] vs. OF: 12 days [IQR 7-15], p = 0.35).
","['children recover faster after laparoscopic (LF) than after open fundoplication (OF', 'Fifty-five children (LF: n\u202f=\u202f27, OF: n\u202f=\u202f28) of the 88 enrolled in the RCT']",['laparoscopic fundoplication'],"['new-onset dysphagia', 'analgesics, overall well-being, and time to return to school/day-care']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0192499', 'cui_str': 'Esophagogastric fundoplasty'}, {'cui': 'C0450382', 'cui_str': '55'}]","[{'cui': 'C0521257', 'cui_str': 'Laparoscopic fundoplication'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0011017', 'cui_str': 'Day Care'}]",88.0,0.284238,"There was no significant difference regarding improvement in overall well-being (LF: 63%, OF: 68%, p = 0.70), new-onset dysphagia (LF: 30%, OF: 18%, p = 0.08), use of analgesics (LF: 15%, OF: 14%, p = 1.00), or time to return to school/day-care (LF: median 7 days [IQR 5-14] vs. OF: 12 days [IQR 7-15], p = 0.35).
","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Fyhn', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway;. Electronic address: thomasfy@gmail.com.'}, {'ForeName': 'Charlotte K', 'Initials': 'CK', 'LastName': 'Knatten', 'Affiliation': 'Department of Pediatrics, Oslo University Hospital, Oslo, Norway;. Electronic address: charlotte@knatten.org.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Edwin', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway;; The Intervention Centre, Oslo University Hospital, Rikshospitalet, Oslo, Norway; Department of Hepatopancreatobiliary Surgery, Oslo University Hospital, Rikshospitalet, Oslo, Norway. Electronic address: bjoedw@ous-hf.no.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Schistad', 'Affiliation': 'Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Oslo, Norway;. Electronic address: uxolsc@ous-hf.no.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Emblem', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway;; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Oslo, Norway;. Electronic address: ragnhild.emblem@medisin.uio.no.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bjørnland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway;; Department of Gastrointestinal and Pediatric Surgery, Oslo University Hospital, Oslo, Norway;. Electronic address: kristin.bjornland@medisin.uio.no.'}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.11.006']
1972,32886901,Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors.,"BACKGROUND


The Controlled Study of Lanreotide Antiproliferative Response in Neuroendocrine Tumors (CLARINET) trial showed prolonged progression-free survival in patients initially treated with lanreotide versus placebo. We evaluated the cost-effectiveness of upfront lanreotide versus active surveillance with lanreotide administered after progression in patients with metastatic enteropancreatic neuroendocrine tumors (NETs), both of which are treatment options recommended in NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors.
METHODS


We developed a Markov model calibrated to the CLARINET trial and its extension. We based the active surveillance strategy on the CLARINET placebo arm. We calculated incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). We modeled lanreotide's cost at $7,638 per 120 mg (average sales price plus 6%), used published utilities (stable disease, 0.77; progressed disease, 0.61), adopted a healthcare sector perspective and lifetime time horizon, and discounted costs and benefits at 3% annually. We examined sensitivity to survival extrapolation and modeled octreotide long-acting release (LAR) ($6,183 per 30 mg). We conducted one-way, multiway, and probabilistic sensitivity analyses.
RESULTS


Upfront lanreotide led to 5.21 QALYs and a cost of $804,600. Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained. Reducing lanreotide's price by 95% (to $370) or 85% (to $1,128) per 120 mg would allow upfront lanreotide to reach ICERs of $100,000/QALY or $150,000/QALY. Across a range of survival curve extrapolation scenarios, pricing lanreotide at $370 to $4,000 or $1,130 to $5,600 per 120 mg would reach ICERs of $100,000/QALY or $150,000/QALY, respectively. Our findings were robust to extensive sensitivity analyses. The ICER modeling octreotide LAR is $482,700/QALY gained.
CONCLUSIONS


At its current price, lanreotide is not cost-effective as initial therapy for patients with metastatic enteropancreatic NETs and should be reserved for postprogression treatment. To be cost-effective as initial therapy, the price of lanreotide would need to be lowered by 48% to 95% or 27% to 86% to reach ICERs of $100,000/QALY or $150,00/QALY, respectively.",2020,"Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained.","['patients initially treated with', 'patients with metastatic enteropancreatic NETs', 'patients with metastatic enteropancreatic neuroendocrine tumors (NETs', 'Metastatic Enteropancreatic Neuroendocrine Tumors']","['octreotide long-acting release (LAR', 'CLARINET placebo', 'upfront lanreotide', 'lanreotide versus placebo', 'lanreotide', 'Upfront lanreotide', 'Initial Versus Delayed Lanreotide']","['progression-free survival', 'cost-effectiveness', 'Cost-Effectiveness', 'incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}]","[{'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0562019', 'cui_str': 'dollar'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0475206,"Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained.","[{'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Barnes', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Lin', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, California; and.'}, {'ForeName': 'Douglas K', 'Initials': 'DK', 'LastName': 'Owens', 'Affiliation': 'VA Palo Alto Health Care System, Palo Alto, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Center for Primary Care and Outcomes Research/Center for Health Policy, Department of Medicine, Stanford University School of Medicine, Stanford, California; and.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Kunz', 'Affiliation': 'Department of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2020.7563']
1973,32865380,Colchicine in Patients with Chronic Coronary Disease.,"BACKGROUND


Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.
METHODS


In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.
RESULTS


A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).
CONCLUSIONS


In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo. (Funded by the National Health Medical Research Council of Australia and others; LoDoCo2 Australian New Zealand Clinical Trials Registry number, ACTRN12614000093684.).",2020,"A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007).","['patients with chronic coronary disease to receive 0.5 mg of', 'Patients with Chronic Coronary Disease', 'patients with recent myocardial infarction', 'patients with chronic coronary disease', '5522 patients underwent randomization; 2762']","['colchicine once daily or matching placebo', 'colchicine', 'Colchicine', 'placebo']","['composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke', 'incidence of death from noncardiovascular causes', 'risk of cardiovascular events', 'median duration', 'incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction', 'composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1998297', 'cui_str': 'Recent myocardial infarction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0444930', 'cui_str': 'End'}]",5522.0,0.707454,"A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.007).","[{'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Nidorf', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Aernoud T L', 'Initials': 'ATL', 'LastName': 'Fiolet', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Mosterd', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Schut', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Tjerk S J', 'Initials': 'TSJ', 'LastName': 'Opstal', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Salem H K', 'Initials': 'SHK', 'LastName': 'The', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Xiao-Fang', 'Initials': 'XF', 'LastName': 'Xu', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ireland', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Lenderink', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Latchem', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Hoogslag', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Anastazia', 'Initials': 'A', 'LastName': 'Jerzewski', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nierop', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Whelan', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Hendriks', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Swart', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Schaap', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Aaf F M', 'Initials': 'AFM', 'LastName': 'Kuijper', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Maarten W J', 'Initials': 'MWJ', 'LastName': 'van Hessen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Pradyot', 'Initials': 'P', 'LastName': 'Saklani', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Tan', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Thompson', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Morton', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Judkins', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bax', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Maurits', 'Initials': 'M', 'LastName': 'Dirksen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Graeme J', 'Initials': 'GJ', 'LastName': 'Hankey', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Charley A', 'Initials': 'CA', 'LastName': 'Budgeon', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Thompson', 'Affiliation': 'From GenesisCare Western Australia (S.M.N., X.-F.X., M.A.I., D.L., A.W., R.H., P.S., I.T., A.G.T., A. Morton, P.L.T.), the Heart and Vascular Research Institute (S.M.N., P.L.T.) and the Department of Neurology (G.J.H.), Sir Charles Gairdner Hospital, and the Faculty of Health and Medical Sciences (G.J.H., P.L.T.) and the School of Population and Global Health (C.A.B.), University of Western Australia, Perth, the Department of Cardiology, Fiona Stanley Hospital, Murdoch, WA (C.J.), and the Harry Perkins Institute of Medical Research, Nedlands, WA (P.L.T.) - all in Australia; the Dutch Network for Cardiovascular Research (A.T.L.F., A. Mosterd, A.S., S.H.K.T., T.L., P.H., A.J., P.N., H.S., J.S., A.F.M.K., M.W.J.H., M.D., M.M.W.A., J.H.C.), the Netherlands Heart Institute (A.T.L.F.), and the Department of Cardiology (A.T.L.F.) and the Julius Center for Health Sciences and Primary Care (A. Mosterd, M.M.W.A.), University Medical Center Utrecht, Utrecht, the Department of Cardiology, Meander Medical Center, Amersfoort (A. Mosterd), the Departments of Cardiology (T.S.J.O., M.D., J.H.C.) and Internal Medicine (W.A.B.), Northwest Clinics, Alkmaar, the Department of Cardiology, Radboud University Medical Center, Nijmegen (T.S.J.O., J.H.C.), the Department of Cardiology, Treant Zorggroep, Hoogeveen, Emmen, and Stadskanaal (S.H.K.T.), the Department of Cardiology, Zuyderland Medical Center, Heerlen and Sittard (T.L.), the Department of Cardiology, Isala Diaconessenhuis, Meppel (P.H.), the Department of Cardiology, Gelre Hospitals, Apeldoorn (A.J.), the Department of Cardiology, Franciscus Hospital (P.N.), and Cardialysis (J.G.P.T.), Rotterdam, the Department of Cardiology, D&A Research and Genetics, Sneek (H.S.), the Department of Cardiology, Amphia and Breda (J.S., M.M.W.A.), the Department of Cardiology, Spaarne Hospital, Haarlem and Hoofddorp (A.F.M.K.), the Department of Cardiology, Green Heart Hospital, Gouda (M.W.J.H.), and the Department of Cardiology, Amsterdam UMC, Amsterdam (J.G.P.T.) - all in the Netherlands; and the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.W.E.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021372']
1974,32877886,Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial.,"Background OBJECTIVE: To investigate the effects of peripheral muscle training (PMT) and different inspiratory muscle training (IMT) methods on respiratory functions, exercise capacity, and biochemistry parameters in coronary artery disease patients with metabolic syndrome.
METHODS


This prospective, single-blind, randomized-controlled study included 60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA] Class I-II, left ventricular ejection fraction >40%). Patients were randomly divided into three groups: neuromuscular electrical stimulation (NMES) plus PMT group (NMES + PMT group, n = 20), IMT plus PMT group (IMT + PMT group, n = 20) and PMT group (PMT group, n = 20). Treatment continued for six weeks for all groups. The NMES was applied to rectus abdominis, IMT was applied with 30% of maximal inspiratory pressures, and PMT was applied at home. Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters were measured before and after training.
RESULTS


There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05). Significant improvements in C-reactive protein and erythrocyte sedimentation rate were observed in NMES + PMT and IMT + PMT groups (p < 0.05). Among the groups, there was a significant difference in maximal inspiratory pressure (p = 0.02) and erythrocyte sedimentation rate (p = 0.037) in favor of NMES + PMT group (p < 0.05).
CONCLUSION


Our study results showed significant improvements in respiratory functions, exercise capacity, and biochemistry markers in all groups. Different IMT methods can be used in cardiopulmonary rehabilitation to improve exercise intolerance in coronary artery disease patients with metabolic syndrome.
CLINICAL TRIAL REGISTRATION NUMBER


NCT03523026.",2020,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","['coronary artery disease patients with metabolic syndrome', '60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA']","['peripheral muscle training (PMT) and different inspiratory muscle training (IMT', 'peripheral and different inspiratory muscle training methods', 'neuromuscular electrical stimulation (NMES) plus PMT group (NMES\xa0+\xa0PMT group, n\xa0=\xa020), IMT plus PMT group (IMT\xa0+\xa0PMT group, n\xa0=\xa020) and PMT group (PMT', 'NMES']","['Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters', 'exercise intolerance', 'maximal inspiratory pressure', 'respiratory functions, exercise capacity, and biochemistry markers', 'erythrocyte sedimentation rate', 'C-reactive protein and erythrocyte sedimentation rate', 'spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O', 'respiratory functions, exercise capacity, and biochemistry parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}]",60.0,0.028139,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","[{'ForeName': 'Kıymet', 'Initials': 'K', 'LastName': 'Muammer', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Mutluay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Medipol University, Istanbul, Turkey. Electronic address: fmutluay@medipol.edu.tr.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Demir', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Alev Arat', 'Initials': 'AA', 'LastName': 'Özkan', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University, Istanbul, Turkey.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106119']
1975,32878448,Heterogeneity in the Effects of Food Vouchers on Nutrition Among Low-Income Adults: A Quantile Regression Analysis.,"PURPOSE


To determine whether baseline fruit and vegetable (FV) intake or other predictors are associated with response to food vouchers (change in FV intake) among low-income adults.
DESIGN


Secondary analysis of a randomized, 2 x 2-factorial, community-based trial.
SETTING


San Francisco, California.
SUBJECTS


359 low-income adults aged ≥21 years old.
INTERVENTION


Participants were mailed $20 of food vouchers monthly for 6 months, and randomized to 1 of 4 arms according to: eligible foods (FV only or any foods) and redemption schedule (weekly or monthly).
MEASURES


Change in FV intake measured in cup equivalents between baseline and month 6 of the trial, based on 24-hour dietary recalls.
ANALYSIS


Quantile multivariate regressions were employed to measure associations between key predictors and change in FV intake across study arms.
RESULTS


FV-only weekly vouchers were associated with increased FV intake at the 25th percentile (0.24 cups/day,  p  = 0.048) and 50th percentile (0.37 cups/day,  p  = 0.02) of the distribution, but not at lower and higher quantiles. Response to the vouchers diminished 0.10 cups/day for each additional household member ( p  = 0.02).
CONCLUSION


Response to food vouchers varied along the FV intake distribution, pointing to some more responsive groups and others potentially needing additional support to increase FV intake. Larger households likely need vouchers of higher dollar value to result in similar changes in dietary intake as that observed in smaller households.",2020,"RESULTS


FV-only weekly vouchers were associated with increased FV intake at the 25th percentile (0.24 cups/day,  p  = 0.048) and 50th percentile (0.37 cups/day,  ","['Low-Income Adults', 'low-income adults', 'San Francisco, California', '359 low-income adults aged ≥21 years old']","['Food Vouchers', 'eligible foods (FV only or any foods) and redemption schedule (weekly or monthly', 'baseline fruit and vegetable (FV) intake']",['FV intake'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}]",359.0,0.197283,"RESULTS


FV-only weekly vouchers were associated with increased FV intake at the 25th percentile (0.24 cups/day,  p  = 0.048) and 50th percentile (0.37 cups/day,  ","[{'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, 8785University of California San Francisco, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Vasconcelos', 'Affiliation': 'Department of Economics, 8788University of California, Irvine, CA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Harding', 'Affiliation': 'Department of Economics, 8788University of California, Irvine, CA, USA.'}, {'ForeName': 'Mandy M', 'Initials': 'MM', 'LastName': 'Carroll', 'Affiliation': 'Stanford Prevention Research Center, 10624Stanford University School of Medicine, CA, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, 10624Stanford University School of Medicine, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Collective Health, San Francisco, MA, USA.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Seligman', 'Affiliation': 'Philip R. Lee Institute for Health Policy Studies, 8785University of California San Francisco, CA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120952991']
1976,32878514,"A controlled, randomized phase II clinical trial for efficacy and safety evaluation of mannuronic acid in secondary progressive form of multiple sclerosis.","BACKGROUND


The β-D-Mannuronic acid (M2000) as a novel immunosuppressive drug, patented (PCT/EP2017/067920), has shown positive effects in experimental model of multiple sclerosis (MS). In this study, our aim was to assess efficacy and safety outcomes in MS treated patients with mannuronic acid compared to the conventional drug.
METHODS


In a 6-month, randomized controlled, phase II trial, we enrolled patients who had secondary progressive multiple sclerosis (SPMS), were 21-54 years of age, with a score of 1-7 on the Expanded Disability Status Scale (EDSS), and who had at least one relapse in the previous 6 months. Patients were administered orally 1000 mg/day (two 500 mg/capsule daily) of M2000. Endpoints included changes in brain magnetic resonance imaging (MRI) measures and the EDSS score, as compared to the conventional drug (interferon beta-1a, interferon beta-1b).
RESULTS


A total of 25 (92.5%) of the M2000 treated patients and 25 conventionally treated patients completed the study. M2000 had better performance compared to the conventional drug regarding to MRI-related measurements, however, the differences between groups were not statistically significant. M2000 decreased the disability progression over the 6-month period. The EDSS score was decreased in the M2000 treated group in the sixth month versus the conventional drug ( p  < 0.009). Furthermore, we did not observe any short-term side effects.
CONCLUSIONS


As compared with the conventional drug, mannuronic acid (M2000) improved the rate of disability progression. This clinical trial demonstrated the efficacy and safety of mannuronic acid in patients with SPMS. (Registered Clinical Trials number, IRCT2017042313739N6).",2020,"M2000 had better performance compared to the conventional drug regarding to MRI-related measurements, however, the differences between groups were not statistically significant.","['enrolled patients who had secondary progressive multiple sclerosis (SPMS), were 21 to 54 years of age, with a score of 1 to 7 on the Expanded Disability Status Scale (EDSS), and who had at least one relapse in the previous 6 months', 'patients with SPMS', 'MS treated patients with']","['mannuronic acid', ' ']","['efficacy and safety outcomes', 'disability progression', 'rate of disability progression', 'EDSS score', 'changes in brain magnetic resonance imaging (MRI) measures and the EDSS score, as compared to the conventional drug (interferon beta-1a, interferon beta-1b']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0162988', 'cui_str': 'mannuronic acid'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}, {'cui': 'C0244713', 'cui_str': 'interferon beta-1b'}]",,0.057528,"M2000 had better performance compared to the conventional drug regarding to MRI-related measurements, however, the differences between groups were not statistically significant.","[{'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Najafi', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nahid Beladi', 'Initials': 'NB', 'LastName': 'Moghadam', 'Affiliation': 'Department of Neurology, Imam Hossein Hospital, Shahid Beheshti University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Saadat', 'Affiliation': 'Mobility Impairment Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.'}, {'ForeName': 'Seyyedeh Masoomeh', 'Initials': 'SM', 'LastName': 'Noorbakhsh', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anita Vali', 'Initials': 'AV', 'LastName': 'Mohammadi', 'Affiliation': 'Shiraz Branch, Islamic Azad University, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Manouchehrinia', 'Affiliation': 'Department of Clinical Neuroscience (CNS), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'National Hospital Organization, Nagasaki Kawatana Medical Center, Nagasaki, Japan.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mirshafiey', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1818741']
1977,32881912,Feasibility of quantifying change in immune white cells in abdominal adipose tissue in response to an immune modulator in clinical obesity.,"BACKGROUND


Obesity is often associated with inflammation in adipose tissue (AT) with release of mediators of atherogenesis. We postulated that it would be feasible to collect sufficient abdominal AT to quantify changes in a broad array of adaptive and innate mononuclear white cells in obese non-diabetic adults in response to a dipeptidyl protease inhibitor (DPP4i), known to inhibit activation of immune white cells.
METHODS


Adults 18-55 years-of-age were screened for abdominal obesity and insulin resistance or impaired glucose tolerance but without known inflammatory conditions. Twenty-one eligible participants consented for study and were randomized 3:1 to receive sitagliptin (DPP4i) at 100mg or matching placebo daily for 28 days. Abdominal AT collected by percutaneous biopsy and peripheral blood mononuclear cell fractions were evaluated before and after treatment; plasma was stored for batch testing.
RESULTS


Highly sensitive C-reactive protein, a global marker of inflammation, was not elevated in the study population. Innate lymphoid cells (ILC) type 3 (ILC-3) in abdominal AT decreased with active treatment compared with placebo (p = 0.04). Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group. Two circulating biomarkers of atherogenesis, interferon-inducible protein-10 (IP-10) and sCD40L declined in plasma (p = 0.02 and p = 0.07, respectively) in the active treatment group, providing indirect validation of a net reduction in inflammation.
CONCLUSIONS


In this pilot study, two cell types of the innate lymphoid system, ILC-3 in AT and ILC-2 PBMCs declined during treatment and as did circulating biomarkers of atherogenesis. Changes in other immune cells were not demonstrable. The study showed that sufficient abdominal AT could be obtained to quantify white cells of both innate and adaptive immunity and to demonstrate changes during therapy with an immune inhibitor.
TRIAL REGISTRATION


ClinicalTrials.gov identifier (NCT number): NCT02576.",2020,Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group.,"['Twenty-one eligible participants consented for study', 'Adults 18-55 years-of-age were screened for abdominal obesity and insulin resistance or impaired glucose tolerance but without known inflammatory conditions', 'obese non-diabetic adults']","['placebo', 'sitagliptin (DPP4i) at 100mg or matching placebo']","['Innate lymphoid cells (ILC) type 3 (ILC-3', 'ILC-2 declined in PBMCs', 'ILC-3 in AT and ILC-2 PBMCs', 'peripheral blood mononuclear cell (PBMC) fractions', 'atherogenesis, interferon-inducible protein-10 (IP-10) and sCD40L declined in plasma']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0086574', 'cui_str': 'Lymphoid Cells'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C1563937', 'cui_str': 'Atherogenesis'}, {'cui': 'C0056978', 'cui_str': 'CXCL10 Chemokine'}, {'cui': 'C1533698', 'cui_str': 'Nitric Oxide Synthase, Type II'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",21.0,0.139292,Other immune white cells in AT and peripheral blood mononuclear cell (PBMC) fractions did not change with treatment compared to placebo (p>0.05); although ILC-2 declined in PBMCs (p = 0.007) in the sitagliptin treatment group.,"[{'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Sattler', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mert', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Ishwarya', 'Initials': 'I', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Lauriane', 'Initials': 'L', 'LastName': 'Galle-Treger', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Lilit', 'Initials': 'L', 'LastName': 'Baronikian', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, United States of America.'}, {'ForeName': 'Pedram Shafiei', 'Initials': 'PS', 'LastName': 'Jahani', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Department of Medicine, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Ostrow School of Dentistry, Division of Physical Therapy and Biokinesiology, University of Southern California, Los Angeles, California, United States of America.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Akbari', 'Affiliation': 'Department of Molecular Microbiology and Immunology, University of Southern California Keck School of Medicine, Los Angeles, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0237496']
1978,32881921,Progressive active mobilization with dose control and training load in critically ill patients (PROMOB): Protocol for a randomized controlled trial.,"The dose of progressive active mobilization is still uncertain. The purpose of this study is to identify if the addition of a protocol of progressive active mobilization with dose and training load control to usual care is effective in reducing the length of stay in intensive care unit (ICU) and the improvement of the functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate in patients hospitalized in ICU. It is Double-blind randomised clinical trial. The setting for this trial will be medical and surgical ICU of a university hospital. The study participants will be 118 patients aged> 18 years admitted to ICU for less than 72 hours. Participants will be randomized to either an experimental or control group. The experimental group will undertake addition of a protocol of progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care. The primary outcome will be length of ICU stay. The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality. All statistical analyses will be conducted following intention-to-treat principles. It has a detailed description of the dose of exercise, was designed with the strictest methodological criteria. These characteristics allow to investigate with greater certainty the results progressive active mobilization in critical patients, allowing replication and future combinations in meta-analyzes.",2020,"The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality.","['118 patients aged> 18 years admitted to ICU for less than 72 hours', 'critically ill patients (PROMOB', 'patients hospitalized in ICU']","['progressive active mobilization with dose and training load control to usual care, while the control group will undertake only usual care']","['length of stay in intensive care unit (ICU', 'Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality', 'functioning, incidence of ICU-acquired weakness (ICUAW), mechanical ventilation duration and mortality rate', 'length of ICU stay']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",118.0,0.1781,"The secondary outcomes will be Cross-sectional area and muscle thickness of the rectus femoris and biceps brachii, Change in muscle strength from the baseline, Functional Status, incidence of ICUAW, Days with mechanical ventilation and Mortality.","[{'ForeName': 'Rodrigo Santos de', 'Initials': 'RS', 'LastName': 'Queiroz', 'Affiliation': 'Program in Medicine and Health of the Faculty of Medicine, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Micheli Bernardone', 'Initials': 'MB', 'LastName': 'Saquetto', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Bruno Prata', 'Initials': 'BP', 'LastName': 'Martinez', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Bianca Bigogno Reis', 'Initials': 'BBR', 'LastName': 'Cazeta', 'Affiliation': 'Program in Medicine and Health of the Faculty of Medicine, Federal University of Bahia, Salvador, Brazil.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hodgson', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mansueto', 'Initials': 'M', 'LastName': 'Gomes-Neto', 'Affiliation': 'Department of Physical Therapy, Institute of Health Sciences, Federal University of Bahia, Salvador, Brazil.'}]",PloS one,['10.1371/journal.pone.0238352']
1979,32883211,Ultrasound-guided versus Shikani optical stylet-aided tracheal intubation: a prospective randomized study.,"BACKGROUND


To compare ultrasound-guided tracheal intubation (UGTI) versus Shikani optical stylet (SOS)-aided tracheal intubation in patients with anticipated normal airway.
METHODS


Sixty patients aged 18-65 years old who presented for elective surgery under general anesthesia were recruited in this prospective randomized study. They were assigned into two equal groups, either an ultrasound-guided group (Group UG, n = 30) or an SOS-aided group (Group SOS, n = 30). After the induction of anesthesia, the tracheal intubation was performed by a specified skilled anesthesiologist. The number of tracheal intubation attempt and the duration of successful intubation on the first attempt were recorded. Complications relative to tracheal intubation including desaturation, hoarseness and sore throat were also recorded.
RESULTS


The first-attempt success rate is 93.3% (28/30) in Group UG and 90% (27/30) in Group SOS (P = 0.640). The second-attempt was all successful for the 2 and 3 patients left in the two groups, and the overall success rate of both groups was 100%. The duration of successful intubation on the first attempt of Group UG was not significantly different from that of Group SOS (34.0 ± 20.8 s vs 35.5 ± 23.2 s, P = 0.784). One patient in Group SOS had desaturation (P = 0.313), and there was none hoarseness in the two groups. Sore throat was detected in both group (4 in Group UG, 5 in Group SOS, P = 0.718).
CONCLUSION


Ultrasound-guided tracheal intubation was as effective as Shikani optical stylet-aided tracheal intubation in adult patients with anticipated normal airway.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR-IIC-17010875 . Date of Registration: 15 March 2017.",2020,"CONCLUSION


Ultrasound-guided tracheal intubation was as effective as Shikani optical stylet-aided tracheal intubation in adult patients with anticipated normal airway.
","['Sixty patients aged 18-65\u2009years old who presented for elective surgery under general anesthesia', 'patients with anticipated normal airway', 'adult patients with anticipated normal airway']","['Ultrasound-guided tracheal intubation', 'ultrasound-guided group (Group UG, n\u2009=\u200930) or an SOS-aided group', 'Ultrasound-guided versus Shikani optical stylet-aided tracheal intubation', 'ultrasound-guided tracheal intubation (UGTI) versus Shikani optical stylet (SOS)-aided tracheal intubation']","['overall success rate', 'duration of successful intubation', 'Sore throat', 'desaturation', 'desaturation, hoarseness and sore throat', 'number of tracheal intubation attempt and the duration of successful intubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]",60.0,0.0543708,"CONCLUSION


Ultrasound-guided tracheal intubation was as effective as Shikani optical stylet-aided tracheal intubation in adult patients with anticipated normal airway.
","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China. 53987816@qq.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Shengjin', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': 'Department of Anesthesia, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China. ge.shengjin@fudan.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-020-01133-4']
1980,32883212,A new randomization procedure based on multiple covariates and applicable to parallel studies with simultaneous enrollment of all subjects prior to intervention.,"BACKGROUND


Parallel intervention studies involving volunteers usually require a procedure to allocate the subjects to study-arms. Statistical models to evaluate the different outcomes of the study-arms will include study-arm as a factor along with any covariate that might affect the results. To ensure that the effects of the covariates are confounded to the least possible extent with the effects of the arms, stratified randomization can be applied. However, there is at present no clear-cut procedure when there are multiple covariates.
METHODS


For parallel study designs with simultaneous enrollment of all subjects prior to intervention, we propose a D-optimal blocking procedure to allocate subjects with known values of the covariates to the study arms. We prove that the procedure minimizes the variances of the baseline differences between the arms corrected for the covariates. The procedure uses standard statistical software.
RESULTS


We demonstrate the potential of the method by an application to a human parallel nutritional intervention trial with three arms and 162 healthy volunteers. The covariates were gender, age, body mass index, an initial composite health score, and a categorical indicator called first-visit group, defining groups of volunteers who visit the clinical centre on the same day (17 groups). Volunteers were allocated equally to the study-arms by the D-optimal blocking procedure. The D-efficiency of the model connecting an outcome with the study-arms and correcting for the covariates equals 99.2%. We simulated 10,000 random allocations of subjects to arms either unstratified or stratified by first-visit group. Intervals covering the middle 95% of the D-efficiencies for these allocations were [82.0, 92.0] and [93.2, 98.4], respectively.
CONCLUSIONS


Allocation of volunteers to study-arms with a D-optimal blocking procedure with the values of the covariates as inputs substantially improves the efficiency of the statistical model that connects the response with the study arms and corrects for the covariates.
TRIAL REGISTRATION


Dutch Trial Register NL7054 ( NTR7259 ). Registered May 15, 2018.",2020,"prior to intervention, we propose a D-optimal blocking procedure to allocate subjects with known values of the covariates to the study arms.",['162 healthy volunteers'],[],[],"[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],[],10000.0,0.019605,"prior to intervention, we propose a D-optimal blocking procedure to allocate subjects with known values of the covariates to the study arms.","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Schoen', 'Affiliation': 'TNO, Utrechtseweg 48, Zeist, 3700 AJ, Netherlands. eric.schoen@kuleuven.be.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Wopereis', 'Affiliation': 'TNO, Utrechtseweg 48, Zeist, 3700 AJ, Netherlands.'}]",BMC medical research methodology,['10.1186/s12874-020-01085-w']
1981,32883241,Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial.,"BACKGROUND


Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. Authors believe a smaller gauge needle may lead to less intravascular uptake and less pain. Theoretically, there is less chance for a smaller gauge needle to encounter a blood vessel during an injection compared to a larger gauge needle. Studies have also shown smaller gauge needle to cause less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.
METHODS


This was a prospective single blind randomized clinical trial performed at outpatient spine practice locations of two academic institutions. One hundred sixty-two consecutive patients undergoing lumbosacral transforaminal epidural injections from February 2018 to June 2019 were recruited and randomized to each arm of the study - 84 patients were randomized to the 22-gauge needle arm and 78 patients to 25-gauge arm. Each transforaminal injection level was considered a separate incidence, hence total number of incidence was 249 (136 in 22-gauge arm and 113 in 25-gauge arm). The primary outcome measure was intravascular uptake during live fluoroscopy and/or blood aspiration. The secondary outcome measure was patient reported pain during the procedure on the numerical rating scale.
RESULTS


Fisher exact test was used to detect differences between 2 groups in regards to intravascular uptake and paired t-tests were used to detect differences in pain scores. The incidence of intravascular uptake for a 22-gauge needle was 5.9% (95% confidence interval: 1.9 to 9.8%) and for a 25-gauge needle, 7.1% (95% confidence interval: 2.4 to 11.8%) [p = 0.701]. Average numerical rating scale scores during the initial needle entry for 22-gauge and 25-gauge needle was 3.46 (95% confidence interval: 2.94 to 3.98) and 3.13 (95% confidence interval: 2.57 to 3.69) respectively [p = 0.375].
CONCLUSIONS


The study showed no statistically significant difference in intravascular uptake or pain perception between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injections.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04350307. Registered 4/17/2020. (Retrospectively registered).",2020,"The incidence of intravascular uptake for a 22-gauge needle was 5.9% (95% confidence interval: 1.9 to 9.8%) and for a 25-gauge needle, 7.1% (95% confidence interval: 2.4 to 11.8%) [p = 0.701].","['outpatient spine practice locations of two academic institutions', 'One hundred sixty-two consecutive patients undergoing lumbosacral transforaminal epidural injections from February 2018 to June 2019 were recruited and randomized to each arm of the study - 84 patients']","['22-gauge needle versus 25-gauge needle', '22-gauge needle and 25-gauge needle', 'lumbosacral epidural injection', '22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection', '22-gauge needle']","['Average numerical rating scale scores', 'intravascular uptake and less pain', 'intravascular uptake or pain perception', 'total number of incidence', 'intravascular uptake during live fluoroscopy and/or blood aspiration', 'incidence of intravascular uptake', 'patient reported pain during the procedure on the numerical rating scale', 'pain scores', 'Differential rates of intravascular uptake and pain perception']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0450404', 'cui_str': '22G'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0456638', 'cui_str': '25G'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0232077', 'cui_str': 'Pulmonary aspiration of blood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443199', 'cui_str': 'Differential'}]",162.0,0.105049,"The incidence of intravascular uptake for a 22-gauge needle was 5.9% (95% confidence interval: 1.9 to 9.8%) and for a 25-gauge needle, 7.1% (95% confidence interval: 2.4 to 11.8%) [p = 0.701].","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Raju', 'Affiliation': 'Department of Orthopedics and Rehabilitation, Yale New Haven Hospital/Yale University, 1 Long Wharf Drive, New Haven, CT, 06511, USA. robin.raju@yale.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mehnert', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rothman Orthopaedic Institute/Thomas Jefferson University Hospital, 925 Chestnut Street, Philadelphia, PA, 19107, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stolzenberg', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rothman Orthopaedic Institute/Thomas Jefferson University Hospital, 925 Chestnut Street, Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Simon', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rothman Orthopaedic Institute/Thomas Jefferson University Hospital, 925 Chestnut Street, Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Conliffe', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rothman Orthopaedic Institute/Thomas Jefferson University Hospital, 925 Chestnut Street, Philadelphia, PA, 19107, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gehret', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Rothman Orthopaedic Institute/Thomas Jefferson University Hospital, 925 Chestnut Street, Philadelphia, PA, 19107, USA.'}]",BMC anesthesiology,['10.1186/s12871-020-01137-0']
1982,32891139,Vitamin D supplementation in obese Sri Lankan children: a randomized controlled trial.,"BACKGROUND


Micronutrient deficiencies are identified among obese individuals. Vitamin D deficiency (VDD) is prevalent in obese children, and is hypothesized to cause insulin resistance and metabolic abnormalities. This study aimed to determine the effect of vitamin D supplementation on obesity and related metabolic abnormalities among obese Sri Lankan children with VDD.
METHODS


A triple-blind randomized controlled trial was conducted among vitamin D deficient (< 20 ng/ml), obese children (n = 96), randomly allocated to three intervention arms - treatment arm receiving weekly vitamin D 2  50,000 IU; supplementation arm receiving 2500 IU weekly and control arm, receiving placebo. Anthropometry, percentage fat mass (%FM) and blood pressure were assessed and fasting blood glucose, fasting insulin, lipid profile, aspartate transaminase (ALT), alanine transaminase (AST), vitamin D, parathyroid hormone (PTH) and hs-CRP and OGTT with 2-h random blood glucose and insulin was performed at baseline and after 24 weeks of treatment. Ethics Review Committee of Faculty of Medicine, University of Colombo approved the protocol.
RESULTS


Waist circumference Z-score, %FM and serum calcium significantly improved across all three arms, ALT significantly improved in treatment and supplementation arms while, BMI Z-score, PTH and vitamin D significantly improved in the treatment arm. Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.
CONCLUSIONS


A strict dietary and physical activity regimen could improve some of the anthropometric, body composition and metabolic profiles, but high dose vitamin D, enhances those improvements. Therefore high dose vitamin D seems to potentiate management outcomes of obese children with vitamin D deficiency.
TRIAL REGISTRATION


The study was registered at the Sri Lanka Clinical Trials Registry (SLCTR/2015/017) on 12th September 2015 at https://slctr.lk/trials/slctr-2015-017 .",2020,"Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.
","['obese individuals', 'obese Sri Lankan children', 'obese children with vitamin D deficiency', '\u200920\u2009ng/ml), obese children (n\u2009=\u200996', 'obese Sri Lankan children with VDD', 'obese children']","['vitamin D supplementation', 'vitamin D', 'Vitamin D deficiency (VDD', 'Vitamin D supplementation', 'vitamin D deficient', 'vitamin D 2  50,000\u2009IU; supplementation arm receiving 2500\u2009IU weekly and control arm, receiving placebo']","['Anthropometry, percentage fat mass (%FM) and blood pressure were assessed and fasting blood glucose, fasting insulin, lipid profile, aspartate transaminase (ALT), alanine transaminase (AST), vitamin D, parathyroid hormone (PTH) and hs-CRP and OGTT with 2-h random blood glucose and insulin', 'BMI Z-score, PTH and vitamin D', 'subscapular (0.048) skin fold thickness, vitamin D', 'Waist circumference Z-score, %FM and serum calcium', 'obesity and related metabolic abnormalities']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0014695', 'cui_str': 'Ergocalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0428567', 'cui_str': 'Random blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0424680', 'cui_str': 'Skin-fold thickness'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.582768,"Biceps (p = 0.035) and subscapular (0.048) skin fold thickness, vitamin D (p = 0.004) and ALT (p = 0.012) significantly improved in the treatment arm.
","[{'ForeName': 'D B D L', 'Initials': 'DBDL', 'LastName': 'Samaranayake', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'S G S', 'Initials': 'SGS', 'LastName': 'Adikaram', 'Affiliation': 'Colombo South Teaching Hospital, Kalubowila, Sri Lanka.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Atapattu', 'Affiliation': 'Lady Ridgeway Hospital, Colombo, Sri Lanka.'}, {'ForeName': 'K M D L D', 'Initials': 'KMDLD', 'LastName': 'Kendaragama', 'Affiliation': 'Lady Ridgeway Hospital, Colombo, Sri Lanka.'}, {'ForeName': 'J T N', 'Initials': 'JTN', 'LastName': 'Senevirathne', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'H D', 'Initials': 'HD', 'LastName': 'Jayasekera', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Wickramasinghe', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. pujithaw@yahoo.com.'}]",BMC pediatrics,['10.1186/s12887-020-02329-w']
1983,32891140,"The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes.","BACKGROUND


Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes' health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue.
METHODS


Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n = 14) or Health Education (HE; n = 14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group.
RESULTS


The recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B = -0.56, p = .009) and after awakening in the morning (B = -0.57, p = .007).
CONCLUSIONS


This study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements.
TRIAL REGISTRATION


Clinical Trials Registry ( NCT03713996 ). Retrospectively registered on 22 October 2018.",2020,"CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue.","[""individuals with T2D and insomnia symptoms on diabetes' health outcomes"", 'Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center', 'people with T2D and insomnia symptoms', '13 participants completed the interventions in each group and are included in the final analysis', 'People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB', 'people with type 2 diabetes (T2D', 'people with type 2 diabetes mellitus']","['CBT-I', 'Cognitive Behavioral Therapy', 'cognitive behavioral therapy']","['glycemic control, DSCB, and fatigue', 'daytime functioning, including DSCB and fatigue', 'blood glucose level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",28.0,0.0734898,"CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue.","[{'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Alshehri', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA. phdalshehri@gmail.com.'}, {'ForeName': 'Shaima A', 'Initials': 'SA', 'LastName': 'Alothman', 'Affiliation': 'Lifestyle and Health Research Center, Princess Nora bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Aqeel M', 'Initials': 'AM', 'LastName': 'Alenazi', 'Affiliation': 'Physical Therapy Department, Prince Sattam Bin Abdulaziz University, Alkharj, Central Region, Saudi Arabia. aqeelalenazi.pt@gmail.com.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Rucker', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA.'}, {'ForeName': 'Milind A', 'Initials': 'MA', 'LastName': 'Phadnis', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miles', 'Affiliation': 'Endocrinology Department, University of Kansas Medical Center, Kansas City, Kansas, USA.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Kluding', 'Affiliation': 'Physical Therapy and Rehabilitation Science Department, University of Kansas Medical Center, 3901 Rainbow Blvd., Mail Stop 2002, Kansas City, Kansas, 66160, USA.'}]",BMC endocrine disorders,['10.1186/s12902-020-00612-6']
1984,32891160,"Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trial.","OBJECTIVES


To investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. To study the effect of GA on the level of cytokines, TNFα, IL8, IL6 IL10, CRP and the viral load. Secondary outcomes will be the effect of GA oral intake on mortality rate and days of hospital admission.
TRIAL DESIGN


Quadruple blind, randomized placebo-controlled clinical trial Phase II & III. Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio) superiority trial of oral GA among seropositive COVID-19 patients.
PARTICIPANTS


Inclusion criteria: COVID-19 infected (newly diagnosed) as proved by real-time PCR within 72 hours of PCR. Age 8-90 years Both genders Exclusion criteria: Intubated patients on parenteral treatment Allergy to Gum Arabic The study will be conducted in COVID Isolation Centres and Soba University Hospital Khartoum State Sudan.
INTERVENTION AND COMPARATOR


Experimental: Intervention Group This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose once daily for four weeks Placebo Comparator: Control group: This group will be provided with pectin powder provided as one-gram-dose once daily for four weeks Both GA and placebo will be in addition to standard care treatment based on local clinical guidelines.
MAIN OUTCOMES


Mean change from baseline score of Immune Response to end of the trial. Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization). Mortality rate: The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo (Four weeks from the start of randomization]).
RANDOMISATION


Randomization (1:1 allocation ratio) and will be conducted using a sequence of computer-generated random numbers by an independent individual. Each participating centre will be assigned a special code generated by the computer. The randomization will be kept by the PI and a research assistant.
BLINDING (MASKING)


Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 110 eligible patients will be randomly assigned to either GA (n=55) or placebo (n=55) groups.
TRIAL STATUS


Protocol Version no 2, 30 th  June 2020. Recruitment will start on 15 th  September 2020. The intended completion date is 15 th  January 2021.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04381871 . Date of trial registration: 11 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization).","['newly diagnosed COVID 19 Patients', 'COVID Isolation Centres and Soba University Hospital Khartoum State Sudan', '110 eligible patients', 'Age 8-90 years', 'newly diagnosed COVID 19 Sudanese patients', 'n=55) groups', 'seropositive COVID-19 patients']","['GA', 'Acacia Senegal extract Gum Arabic (GA) supplementation', 'parenteral treatment Allergy to Gum Arabic', 'pectin powder provided as one-gram-dose once daily for four weeks', 'placebo', 'Acacia Senegal (Gum Arabic', 'oral GA']","['effect of GA oral intake on mortality rate and days of hospital admission', 'level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values', 'level of cytokines, TNFα, IL8, IL6 IL10, CRP and the viral load', 'Mortality rate']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038642', 'cui_str': 'Sudan'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241297', 'cui_str': 'Sudanese'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}]","[{'cui': 'C0018389', 'cui_str': 'Gum arabic'}, {'cui': 'C0330702', 'cui_str': 'Acacia senegal'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0030744', 'cui_str': 'Pectin'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1321911', 'cui_str': 'Oral gum'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018389', 'cui_str': 'Gum arabic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",110.0,0.452304,"Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization).","[{'ForeName': 'Lamis', 'Initials': 'L', 'LastName': 'Kaddam', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Alneelain University Khartoum, P.O. Box: 11121, 12702, Khartoum, Sudan. lamiskaddam@hotmail.com.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Babiker', 'Affiliation': 'Department of Physiology, Faculty of Medicine, National University-Sudan, Khartoum, Sudan.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Microbiology, Faculty of Medical Laboratory Sciences, International University of Africa, Khartoum, Sudan.'}, {'ForeName': 'Shahinaz', 'Initials': 'S', 'LastName': 'Satti', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Alneelain University Khartoum, P.O. Box: 11121, 12702, Khartoum, Sudan.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Nile University, Khartoum, Sudan.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Elamin', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Alneelain University, Khartoum, Sudan.'}, {'ForeName': 'Mowaia', 'Initials': 'M', 'LastName': 'Mukhtar', 'Affiliation': 'Institute of Endemic Diseases, Faculty of Medicine, University of Khartoum, Khartoum, Sudan.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Elnimeiri', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Alneelain University, Khartoum, Sudan.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Saeed', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Khartoum, Khartoum, Sudan.'}]",Trials,['10.1186/s13063-020-04707-2']
1985,32891163,Growth hormone alleviates oxidative stress and improves the IVF outcomes of poor ovarian responders: a randomized controlled trial.,"BACKGROUND


Oxidative stress (OS), defined as an imbalance between excessive reactive oxygen species (ROS) and/or reactive nitrogen species (RNS) production and antioxidant insufficiency, has been suggested to be involved in the pathogenesis of poor ovarian response (POR). Growth hormone (GH) can reduce OS in some cell types. This study investigated whether GH can improve OS and the in vitro fertilization and embryo transfer (IVF-ET) outcomes of poor ovarian responders.
METHODS


This study enrolled 105 patients with POR and 58 patients without POR (controls) who were diagnosed according to the Bologna criteria and underwent conventional IVF-ET. Poor ovarian responders were randomly assigned to two groups: the POR-GH group, which received pretreatment with GH 4 IU/d on day 2 of the previous menstrual cycle before IVF until the trigger day, and the POR-C group, which received no pretreatment. OS markers in follicular fluid (FF), ROS levels in granulosa cells (GCs), and the IVF outcomes of the groups were compared.
RESULTS


Endometrial thickness on trigger day, the number of cleaved embryos, the number of higher-quality embryos, and the rates of embryo formation, higher-quality embryo formation, implantation and clinical pregnancy were significantly increased in the POR-GH group compared with the POR-C group (P < 0.05). Moreover, compared to those in the non-POR group, FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs were significantly higher, whereas superoxide dismutase (SOD) and the total antioxidant capacity (TAC) were significantly lower in the POR-C group (P < 0.05). Furthermore, compared with those in the POR-C group, the FF TAC was significantly increased in the POR-GH group, and TOS, OSI and intracellular ROS levels were significantly reduced (P < 0.05).
CONCLUSIONS


Pretreatment with GH alleviates OS and improves oocyte quality and IVF outcomes of poor ovarian responders.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. ChiCTR1900021269 . Registered 8 February 2019, http://www.chictr.org.cn/edit.aspx?pid=35837&htm=4 .",2020,"Moreover, compared to those in the non-POR group, FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs were significantly higher, whereas superoxide dismutase (SOD) and the total antioxidant capacity (TAC) were significantly lower in the POR-C group (P < 0.05).","['poor ovarian responders', 'Poor ovarian responders', '105 patients with POR and 58 patients without POR (controls) who were diagnosed according to the Bologna criteria and underwent conventional IVF-ET']","['Growth hormone', 'GH alleviates OS', 'Growth hormone (GH', 'GH', 'POR-GH']","['number of cleaved embryos, the number of higher-quality embryos', 'rates of embryo formation, higher-quality embryo formation, implantation and clinical pregnancy', 'OS markers in follicular fluid (FF), ROS levels in granulosa cells (GCs), and the IVF outcomes', 'FF TAC', 'oocyte quality and IVF outcomes', 'FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs', 'IVF outcomes', 'superoxide dismutase (SOD) and the total antioxidant capacity (TAC', 'TOS, OSI and intracellular ROS levels']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",105.0,0.0640384,"Moreover, compared to those in the non-POR group, FF malondialdehyde (MDA), total oxidant status (TOS), oxidative stress index (OSI) and ROS levels in GCs were significantly higher, whereas superoxide dismutase (SOD) and the total antioxidant capacity (TAC) were significantly lower in the POR-C group (P < 0.05).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""Reproductive Medicine Centre, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, #290 Shayan West Second Street, Wuhou District, Chengdu, Sichuan, People's Republic of China. gongyan0619@163.com.""}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Genetics, School of Bioscience and Technology, Chengdu Medical College, #783 Xindu Avenue, Xindu District, Chengdu, Sichuan, 610500, People's Republic of China. zhangkunyyo@163.com.""}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Xiong', 'Affiliation': ""Reproductive Medicine Centre, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, #290 Shayan West Second Street, Wuhou District, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Jiajing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Reproductive Medicine Centre, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, #290 Shayan West Second Street, Wuhou District, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': ""Department of Genetics, School of Bioscience and Technology, Chengdu Medical College, #783 Xindu Avenue, Xindu District, Chengdu, Sichuan, 610500, People's Republic of China.""}, {'ForeName': 'Shengfang', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""Department of Medical Genetics and Prenatal Diagnosis, Sichuan Provincial Women's and Children's Hospital, The Affiliated Women's and children's Hospital of Chengdu Medical College, Chengdu, Sichuan, People's Republic of China.""}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-020-00648-2']
1986,32891286,The effectiveness of cupping therapy on chronic fatigue syndrome: A single-blind randomized controlled trial.,"BACKGROUND


and purpose: We investigated the effectiveness of cupping therapy with three different pressures in patients with chronic fatigue syndrome (CFS).
MATERIALS AND METHODS


The participants were randomly assigned to three groups, as follows: cupping pressure of -0.02 mpa (n = 38), -0.03 mpa (n = 38), or -0.05 mpa (n = 36). Each group received cupping treatment that consisted of 10 sessions over 5 weeks (2 sessions per week). The primary outcomes were Fatigue Scale (FS-14) score and Fatigue Assessment Instrument (FAI) score after 5 and 10 sessions. The secondary outcomes were the Self-Rating Anxiety Scale (SAS) score, the Self-Rating Depression Scale (SDS) score, and the Pittsburgh Sleep Quality Index (PSQI) score.
RESULTS


There were 91 participants who completed the trial. After five sessions of treatment, the primary outcome of FS-14 score decreased by 3.20 (2.19, 4.21) in the -0.02 mpa group, by 2.39 (1.51, 3.27) in the -0.03 mpa group, and by 3.40 (2.28, 4.52) in the -0.05 mpa group (P = 0.667). After 10 sessions of treatment, the outcome of FS-14 score decreased by 5.00 (3.79, 6.21) in the -0.02 mpa group, by 4.06 (3.07, 5.05) in the -0.03 mpa group, and by 4.77 (3.52, 5.94) in the -0.05 mpa group (P = 0.929). And, the results were statistically different between 5 sessions and 10 sessions of treatment (P < 0.01). However, there were no statistical differences in FAI, SAS, SDS, and PSQI scores between the three groups after 5 sessions and 10 sessions of treatment.
CONCLUSIONS


In conclusion, cupping therapy has significantly relieved fatigue symptoms and improved emotion and sleep condition of CFS patients, and 10 sessions of treatment had superior results compared with 5 sessions in each group. Moreover, in 5 sessions of treatment, cupping with high pressure showed better improvement in fatigue syndromes and sleep condition according to effective rates.
TRIAL REGISTRATION


Chinese clinical trial registry (ChiCTR1800017590); Ethical approval number: ChiECRCT-20180085.",2020,"However, there were no statistical differences in FAI, SAS, SDS, and PSQI scores between the three groups after 5 sessions and 10 sessions of treatment.
","['91 participants who completed the trial', 'patients with chronic fatigue syndrome (CFS', 'chronic fatigue syndrome']",['cupping therapy'],"['Fatigue Scale (FS-14) score and Fatigue Assessment Instrument (FAI) score', 'fatigue syndromes and sleep condition', 'fatigue symptoms and improved emotion and sleep condition', 'FS-14 score', 'Self-Rating Anxiety Scale (SAS) score, the Self-Rating Depression Scale (SDS) score, and the Pittsburgh Sleep Quality Index (PSQI) score', 'FAI, SAS, SDS, and PSQI scores']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}]","[{'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",91.0,0.0802887,"However, there were no statistical differences in FAI, SAS, SDS, and PSQI scores between the three groups after 5 sessions and 10 sessions of treatment.
","[{'ForeName': 'Xiu-Dong', 'Initials': 'XD', 'LastName': 'Meng', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: xiudong19@qq.com.'}, {'ForeName': 'Hao-Ran', 'Initials': 'HR', 'LastName': 'Guo', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: guohaoran0517@sina.com.'}, {'ForeName': 'Qing-Ying', 'Initials': 'QY', 'LastName': 'Zhang', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: zhangqingying0928@163.com.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: 2096599174@qq.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: chenyongtcm@163.com.'}, {'ForeName': 'Mu-Yang', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: tjutcmlimuyang@163.com.'}, {'ForeName': 'Xue-Mao', 'Initials': 'XM', 'LastName': 'Zhuo', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: zhuoxm_tjutcm@163.com.'}, {'ForeName': 'Mei-Juan', 'Initials': 'MJ', 'LastName': 'Wang', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: 429344246@qq.com.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Shan', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: 2646586551@qq.com.'}, {'ForeName': 'Yi-Nan', 'Initials': 'YN', 'LastName': 'Gong', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: 1457907206@qq.com.'}, {'ForeName': 'Ning-Cen', 'Initials': 'NC', 'LastName': 'Li', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: liningcen1009@qq.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: tjutcmchenbo@163.com.'}, {'ForeName': 'Ze-Lin', 'Initials': 'ZL', 'LastName': 'Chen', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: chenzelin328@163.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, China. Electronic address: guoyi_168@163.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101210']
1987,32891287,The effect of interactive games compared to painting on preoperative anxiety in Iranian children: A randomized clinical trial.,"BACKGROUND AND AIMS


An important responsibility of nurses is to optimize children's physiological and psychological health and to help them adapt to their new conditions and anxiety. In this study, we compare the effect of interactive games and painting on preoperative anxiety in Iranian children.
METHODS


This pre-post randomized clinical trial was conducted on 172 children aged 3-12 years undergoing elective surgery and randomly divided into three groups, including interactive games group (n = 64), painting group (n = 55), and control group (n = 53). The children's anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS).
RESULTS


The results showed significant differences between the three groups (P < 0.001). Also, results showed that the mean anxiety score was significantly lower in the painting group.
CONCLUSION


Based on these conclusions, nurses should collaborate with medical teams to routinely use non-pharmacological methods such as the painting and the interactive games to alleviate preoperative anxiety in children.",2020,The results showed significant differences between the three groups (P < 0.001).,"['children', 'Iranian children', '172 children aged 3-12 years undergoing elective surgery']","['interactive games group', 'interactive games', 'interactive games and painting']","['modified Yale Preoperative Anxiety Scale (mYPAS', 'preoperative anxiety', 'mean anxiety score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",172.0,0.0325702,The results showed significant differences between the three groups (P < 0.001).,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Forouzandeh', 'Affiliation': 'Community-oriented Nursing and Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: nas_for@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Drees', 'Affiliation': 'Department of Epidemiology and Statistics, Faculty of Medicine, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Forouzandeh', 'Affiliation': 'Department of Midwifery, County Health Center, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Darakhshandeh', 'Affiliation': 'Department of Midwifery, Hajar Hospital, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101211']
1988,32891289,"The effect of breathing exercise on nausea, vomiting and functional status in breast cancer patients undergoing chemotherapy.","OBJECTIVE


The aim of this study is to determine the effect of breathing exercise on nausea, vomiting, and functional status in breast cancer patients undergoing chemotherapy.
METHODS


This randomized controlled trial was conducted with a total of 60 breast cancer patients in the ambulatory chemotherapy unit of a university hospital. The data were collected using Patient Information Form, Functional Living Index-Cancer (FLI-C), Visual Analog Scale, and Patient Diary. The patients were followed up for the first seven days. While the control group received routine nursing care until the posttest, the intervention group received breathing exercise for six days. On the seventh day, FLI-C was repeated for all the patients.
RESULTS


It was determined that the patients in the intervention group had less number of nausea, vomiting, and retching episodes after the breathing exercise (p < 0.05) and experienced lower severity of nausea (p < 0.05) compared to patients in the control group.
CONCLUSION


Consequently, it was determined that the breathing exercise reduced chemotherapy-induced nausea, vomiting and retching in breast cancer patients and affected positively functional status of patients.",2020,"Consequently, it was determined that the breathing exercise reduced chemotherapy-induced nausea, vomiting and retching in breast cancer patients and affected positively functional status of patients.","['60 breast cancer patients in the ambulatory chemotherapy unit of a university hospital', 'breast cancer patients undergoing chemotherapy']","['routine nursing care', 'breathing exercise']","['nausea, vomiting, and functional status', 'nausea, vomiting and retching', 'number of nausea, vomiting, and retching episodes', 'nausea, vomiting and functional status', 'severity of nausea', 'Functional Living Index-Cancer (FLI-C), Visual Analog Scale, and Patient Diary']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276154', 'cui_str': 'Ambulatory chemotherapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",60.0,0.0364722,"Consequently, it was determined that the breathing exercise reduced chemotherapy-induced nausea, vomiting and retching in breast cancer patients and affected positively functional status of patients.","[{'ForeName': 'Didem Ondaş', 'Initials': 'DO', 'LastName': 'Aybar', 'Affiliation': 'Nurse, Şehitkamil State Hospital, Anesthesia Unit, Gaziantep, Turkey. Electronic address: didemondas@hotmail.com.'}, {'ForeName': 'Serap Parlar', 'Initials': 'SP', 'LastName': 'Kılıc', 'Affiliation': 'İnonu University Faculty of Nursing, Department of Internal Medicine Nursing, Malatya, Turkey. Electronic address: serap.parlar@inonu.edu.tr.'}, {'ForeName': 'Havva Yeşil', 'Initials': 'HY', 'LastName': 'Çınkır', 'Affiliation': 'Gaziantep University, Şahinbey Oncology Hospital, Gaziantep, Turkey. Electronic address: drhavva1982@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101213']
1989,32891291,Effects of foot massage and patient education in patients undergoing coronary artery bypass graft surgery: A randomized controlled trial.,"BACKGROUND


Anxiety, pain, and fatigue are common postoperative problems that disturb the recovery and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery. These postoperative problems are associated with prolonged recovery and decreased quality of life. This study was aimed at evaluating the combined effects of foot massage and patient education on anxiety, fatigue, pain, self-efficacy, and quality of life in patients undergoing CABG surgery.
MATERIAL AND METHODS


In this randomized controlled trial (RCT), 130 participants were randomly allocated to experimental (n = 65) and control (n = 65) groups. The experimental group received a combination of foot massage and patient education as interventions and the control group received usual care of the hospital.
RESULTS


The experimental group had a significant decrease in anxiety (p = 0.001), fatigue (p = 0.001), pain (p = 0.001), and increased self-efficacy (p = 0.001) and quality of life (p = 0.001).
CONCLUSION


The combined form of foot massage and patient education is effective in decreasing anxiety, fatigue, pain, and increasing self-efficacy and the quality of life. These interventions will support the recovery of patients and reduce their suffering.",2020,"The experimental group had a significant decrease in anxiety (p = 0.001), fatigue (p = 0.001), pain (p = 0.001), and increased self-efficacy (p = 0.001) and quality of life (p = 0.001).
","['patients undergoing coronary artery bypass graft surgery', 'patients undergoing CABG surgery', 'patients undergoing coronary artery bypass graft (CABG) surgery', '130 participants']","['combination of foot massage and patient education as interventions and the control group received usual care of the hospital', 'foot massage and patient education']","['anxiety, fatigue, pain, and increasing self-efficacy and the quality of life', 'anxiety, fatigue, pain, self-efficacy, and quality of life', 'fatigue', 'quality of life', 'anxiety', 'self-efficacy', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",130.0,0.172855,"The experimental group had a significant decrease in anxiety (p = 0.001), fatigue (p = 0.001), pain (p = 0.001), and increased self-efficacy (p = 0.001) and quality of life (p = 0.001).
","[{'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Chandrababu', 'Affiliation': 'Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India. Electronic address: ramesh.c@manipal.edu.'}, {'ForeName': 'Baby S', 'Initials': 'BS', 'LastName': 'Nayak', 'Affiliation': 'Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India. Electronic address: baby.s@manipal.edu.'}, {'ForeName': 'Vasudev Baburaya', 'Initials': 'VB', 'LastName': 'Pai', 'Affiliation': 'Royal Papworth Hospital, NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0AY, United Kingdom. Electronic address: vasudevpai@gmail.com.'}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'N', 'Affiliation': 'Department of Data Science, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India. Electronic address: ravi.shankar@manipal.edu.'}, {'ForeName': 'Linu Sara', 'Initials': 'LS', 'LastName': 'George', 'Affiliation': 'Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India. Electronic address: linu.j@manipal.edu.'}, {'ForeName': 'Elsa Sanatombi', 'Initials': 'ES', 'LastName': 'Devi', 'Affiliation': 'Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India. Electronic address: elsa.sana@manipal.edu.'}, {'ForeName': 'Anice', 'Initials': 'A', 'LastName': 'George', 'Affiliation': 'Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India. Electronic address: anice.george@manipal.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101215']
1990,32893707,Efficacy and safety of fractional CO 2  laser and tranexamic acid versus microneedling and tranexamic acid in the treatment of infraorbital hyperpigmentation.,"OBJECTIVE


To compare the efficacy and safety of microneedling and fractional CO 2  laser in combination with tranexamic acid (TA) in the treatment of infra-orbital hyperpigmentation.
PATIENTS AND METHODS


This split-face clinical trial performed on 30 volunteers. The patients were randomly assigned to treat with fractional CO 2  laser and microneedling, both combined with TA topically. Three monthly treatment sessions were performed. Two blinded dermatologists evaluated the response after each treatment session and one and three months after the last session. We also asked patients to evaluate their overall satisfaction at the final follow up. Adverse effects have also been documented.
RESULTS


Both methods showed significant improvement in all sessions comparing with the baseline state ( p  value <.05). There were no significant differences between two methods on the days 30, 90, and 150. But the laser showed significantly higher improvement on day 60. The patients' satisfaction did not reveal any significant difference between the two sides. Adverse events were temporary with no significant difference between both sides except for erythema that lasts longer with microneedling.
CONCLUSIONS


Both fractional CO 2  laser and microneedling in combination with topical TA seem to be effective modalities in the treatment of infraorbital hyperpigmentation with no significant side effects.",2020,Adverse events were temporary with no significant difference between both sides except for erythema that lasts longer with microneedling.,"['infraorbital hyperpigmentation', '30 volunteers', 'infra-orbital hyperpigmentation']","['fractional CO2 laser and microneedling, both combined with tranexamic acid topically', 'microneedling and fractional CO2 laser', 'tranexamic acid', 'fractional CO2 laser and tranexamic acid versus microneedling and tranexamic acid', 'fractional CO2 laser and microneedling in combination with topical tranexamic acid']","['efficacy and safety', 'Adverse events']","[{'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",30.0,0.0374898,Adverse events were temporary with no significant difference between both sides except for erythema that lasts longer with microneedling.,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Ghandehari', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza M', 'Initials': 'RM', 'LastName': 'Robati', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Niknezhad', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Hajizadeh', 'Affiliation': 'Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Tehranchinia', 'Affiliation': 'Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1819527']
1991,32893710,"Effects of a Vegetarian Diet on Cardiometabolic Risk Factors, Gut Microbiota, and Plasma Metabolome in Subjects With Ischemic Heart Disease: A Randomized, Crossover Study.","Background A vegetarian diet (VD) may reduce future cardiovascular risk in patients with ischemic heart disease. Methods and Results A randomized crossover study was conducted in subjects with ischemic heart disease, assigned to 4-week intervention periods of isocaloric VD and meat diet (MD) with individually designed diet plans, separated by a 4-week washout period. The primary outcome was difference in oxidized low-density lipoprotein cholesterol (LDL-C) between diets. Secondary outcomes were differences in cardiometabolic risk factors, quality of life, gut microbiota, fecal short-chain and branched-chain fatty acids, and plasma metabolome. Of 150 eligible patients, 31 (21%) agreed to participate, and 27 (87%) participants completed the study. Mean oxidized LDL-C (-2.73 U/L), total cholesterol (-5.03 mg/dL), LDL-C (-3.87 mg/dL), and body weight (-0.67 kg) were significantly lower with the VD than with the MD. Differences between VD and MD were observed in the relative abundance of several microbe genera within the families Ruminococcaceae, Lachnospiraceae, and Akkermansiaceae. Plasma metabolites, including l-carnitine, acylcarnitine metabolites, and phospholipids, differed in subjects consuming VD and MD. The effect on oxidized LDL-C in response to the VD was associated with a baseline gut microbiota composition dominated by several genera of Ruminococcaceae. Conclusions The VD in conjunction with optimal medical therapy reduced levels of oxidized LDL-C, improved cardiometabolic risk factors, and altered the relative abundance of gut microbes and plasma metabolites in patients with ischemic heart disease. Our results suggest that composition of the gut microbiota at baseline may be related to the reduction of oxidized LDL-C observed with the VD. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02942628.",2020,"Differences between VD and MD were observed in the relative abundance of several microbe genera within the families Ruminococcaceae, Lachnospiraceae, and Akkermansiaceae.","['subjects with ischemic heart disease', 'patients with ischemic heart disease', '150 eligible patients, 31 (21%) agreed to participate, and 27 (87%) participants completed the study', 'Subjects With Ischemic Heart Disease']","['isocaloric VD and meat diet (MD) with individually designed diet plans', 'Vegetarian Diet', ' A vegetarian diet (VD', 'Registration URL']","['oxidized LDL-C, improved cardiometabolic risk factors', 'Mean oxidized LDL-C (-2.73\xa0U/L), total cholesterol', 'body weight', 'cardiometabolic risk factors, quality of life, gut microbiota, fecal short-chain and branched-chain fatty acids, and plasma metabolome', 'oxidized low-density lipoprotein cholesterol (LDL-C', 'Plasma metabolites, including l-carnitine, acylcarnitine metabolites, and phospholipids', 'relative abundance of gut microbes and plasma metabolites', 'Cardiometabolic Risk Factors, Gut Microbiota, and Plasma Metabolome']","[{'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C3541384', 'cui_str': 'URL'}]","[{'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4517637', 'cui_str': '2.73'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0596221', 'cui_str': 'Branched chain fatty acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0368608', 'cui_str': 'Acylcarnitine'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]",150.0,0.0255706,"Differences between VD and MD were observed in the relative abundance of several microbe genera within the families Ruminococcaceae, Lachnospiraceae, and Akkermansiaceae.","[{'ForeName': 'Demir', 'Initials': 'D', 'LastName': 'Djekic', 'Affiliation': 'Department of Cardiology, Faculty of Health Örebro University Hospital Örebro Sweden.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""Engineering and Nutritional Science Shaanxi Normal University Xi'an China.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Brolin', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine University of Gothenburg Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Carlsson', 'Affiliation': 'Chalmers University of Technology Gothenburg Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Särnqvist', 'Affiliation': 'Department of Cardiology, Faculty of Health Örebro University Hospital Örebro Sweden.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Savolainen', 'Affiliation': 'Chalmers University of Technology Gothenburg Sweden.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Clinical Epidemiology and Biostatistics, School of Medical Sciences Örebro University Örebro Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Bäckhed', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine University of Gothenburg Sweden.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Tremaroli', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine University of Gothenburg Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Chalmers University of Technology Gothenburg Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Frøbert', 'Affiliation': 'Department of Cardiology, Faculty of Health Örebro University Hospital Örebro Sweden.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016518']
1992,32893717,Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial.,"Background Early reduction in albuminuria with an SGLT2 (sodium-glucose cotransporter 2) inhibitor may be a positive indicator of long-term cardiovascular and renal benefits. We assessed changes in albuminuria during the first 12 weeks of treatment and subsequent long-term cardiovascular and renal risks associated with the SGLT2 inhibitor, empagliflozin, in the EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 diabetes Mellitus Patients) trial. Methods and Results We calculated the percentage urinary albumin creatinine ratio (UACR) change from baseline to week 12 in 6820 participants who did not experience a cardiovascular outcome (including 3-point major cardiovascular events and cardiovascular death or hospitalization for heart failure) or renal outcome (defined as 40% decline in estimated glomerular filtration rate from baseline, estimated glomerular filtration rate <15 mL/min per 1.73 m 2 , need for continuous renal-replacement therapy, or renal death) during the first 12 weeks. Multivariable Cox regression models were used to estimate the hazard ratio (HR) for each 30% reduction in UACR with outcomes. Empagliflozin reduced UACR by 18% (95% CI, 14-22) at week 12 compared with placebo, and increased the likelihood of a >30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27-1.58;  P <0.001). During 3.0 years of follow-up, 704 major cardiovascular events, 440 cardiovascular deaths/hospitalizations for heart failure, and 168 renal outcomes were observed. Each 30% decrease in UACR during the first 12 weeks was statistically significantly associated with a lower hazard for major cardiovascular events (HR, 0.96; 95% CI, 0.93-0.99;  P =0.012), cardiovascular deaths/hospitalizations for heart failure (HR, 0.94; 95% CI, 0.91-0.98;  P =0.003), and renal outcomes (HR, 0.83; 95% CI, 0.78-0.89;  P <0.001). Conclusions Short-term reduction in UACR was more common with empagliflozin and was statistically significantly associated with a decreased risk of long-term cardiovascular and renal outcomes. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT01131676.",2020,"Empagliflozin reduced UACR by 18% (95% CI, 14-22) at week 12 compared with placebo, and increased the likelihood of a >30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27-1.58;  P <0.001).","['Type 2 Diabetes Mellitus', 'Type 2 diabetes Mellitus Patients) trial', '6820 participants who did not experience a cardiovascular outcome (including 3-point major cardiovascular events and cardiovascular death or hospitalization for heart failure) or renal outcome (defined as 40% decline in estimated glomerular filtration rate from baseline, estimated glomerular filtration rate <15\xa0mL/min per 1.73\xa0m 2 , need for continuous renal-replacement therapy, or renal death) during the first 12\xa0weeks']","['Empagliflozin', 'placebo', 'empagliflozin', 'SGLT2 inhibitor, empagliflozin']","['Albuminuria and Risk of Cardiovascular and Renal Outcomes', 'percentage urinary albumin creatinine ratio (UACR) change', 'major cardiovascular events', 'cardiovascular deaths/hospitalizations for heart failure', 'UACR', 'risk of long-term cardiovascular and renal outcomes', 'renal outcomes', '704 major cardiovascular events, 440 cardiovascular deaths/hospitalizations for heart failure, and 168 renal outcomes']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C4319556', 'cui_str': '168'}]",6820.0,0.255298,"Empagliflozin reduced UACR by 18% (95% CI, 14-22) at week 12 compared with placebo, and increased the likelihood of a >30% reduction in UACR (odds ratio, 1.42; 95% CI, 1.27-1.58;  P <0.001).","[{'ForeName': 'Simke W', 'Initials': 'SW', 'LastName': 'Waijer', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology Yale University School of Medicine New Haven CT.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research InstituteMt Sinai HospitalUniversity of Toronto Ontario Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Boehringer Ingelheim International GmbH Ingelheim Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mattheus', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Germany.'}, {'ForeName': 'Maximillian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH Ingelheim Germany.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Inker', 'Affiliation': 'Tufts University School of MedicineTufts Medical Center Boston MA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine Division of Nephrology Würzburg University Clinic Würzburg Germany.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016976']
1993,32893745,"Vitamin E and ginseng supplementation to enhance female sexual function: a randomized, double-blind, placebo-controlled, clinical trial.","Female sexual disorders (FSD) are a spectrum of disorders common among women, especially in their middle age, which can reduce the female quality of life substantially. We aimed to evaluate the effects of a combined vitamin E and ginseng supplement on amelioration of female sexual dysfunction. In a 6-week, double-blind, randomized, placebo-controlled clinical trial, participants, suffering from sexual dysfunction based on the female sexual function index (FSFI) questionnaire, were randomly allocated to receive the supplement (100 IU vitamin E, 67 mg Korean ginseng, and 40 mg Siberian ginseng) or placebo daily. The primary outcome in our trial was the change in the FSFI total score. Sixty-nine participants were enrolled, but only 31 in each group completed the trial. Changes in the FSFI total score and its domain scores were significant during the trial course within each group. However, the supplement only ameliorated desire and satisfaction domains superior to the placebo. In case of the total score and other domains, the changes were insignificantly different between the treatment groups. Although our study could not find additional benefits for the vitamin E and ginseng supplement over placebo in enhancing sexual function overall, the supplement worked better in enhancing sexual desire and satisfaction.",2020,"In case of the total score and other domains, the changes were insignificantly different between the treatment groups.","['Female sexual disorders (FSD', 'participants, suffering from sexual dysfunction based on the female sexual function index (FSFI) questionnaire', 'Sixty-nine participants were enrolled, but only 31 in each group completed the trial']","['Vitamin E and ginseng supplementation', 'supplement (100 IU vitamin E, 67 mg Korean ginseng, and 40 mg Siberian ginseng) or placebo daily', 'combined vitamin E and ginseng supplement', 'placebo', 'vitamin E and ginseng supplement over placebo']","['sexual desire and satisfaction', 'FSFI total score and its domain scores', 'amelioration of female sexual dysfunction', 'female sexual function', 'FSFI total score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0237873', 'cui_str': 'Sexual Disorders, Physiological'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C1035215', 'cui_str': 'Ginseng, Siberian'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}]",69.0,0.393237,"In case of the total score and other domains, the changes were insignificantly different between the treatment groups.","[{'ForeName': 'Kiandokht', 'Initials': 'K', 'LastName': 'Ghamari', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': 'Infertility Ward, Arash Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Jafarinia', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Borna', 'Initials': 'B', 'LastName': 'Tadayon Najafabadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Shokraee', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Esalatmanesh', 'Affiliation': 'Infertility Ward, Arash Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences , Tehran, Iran.'}]",Women & health,['10.1080/03630242.2020.1803465']
1994,32893748,A novel treatment modality for myogenous temporomandibular disorders using aromatherapy massage with lavender oil: A randomized controlled clinical trial.,"OBJECTIVE


To investigate the effect of aromatherapy massage on pain intensity and maximal mouth opening (MMO) in patients with myogenous TMD.
METHODS


Ninety-one patients were randomly assigned to three groups: Group L (aromatherapy massage with lavender oil, test), group P (massage with sweet almond oil, placebo), and group C (control). Participants were evaluated at T0 (before the intervention), T1 (immediately after the intervention), and T2 (2-month follow-up). Data were analyzed using one-way ANOVA, Tukey's HSD, and Kruskal-Wallis tests.
RESULTS


For T1 and T2, group L showed the greatest MMO values (48.01 ± 0.85 mm; 45.67 ± 0.84 mm), while group C exhibited the lowest values (39.13 ± 0.49 mm; 39.66 ± 0.82 mm) ( p  < 0.001). For VAS, group L revealed the lowest pain values at T1 (2) and T2 (2) ( p  < 0.001).
DISCUSSION


Aromatherapy massage with lavender oil was effective in the management of painful TMD conditions and limited mouth opening.",2020,"For VAS, group L revealed the lowest pain values at T1 (2) and T2 (2) ( p  < 0.001).
","['myogenous temporomandibular disorders', 'patients with myogenous TMD', 'Ninety-one patients']","['aromatherapy massage', 'Group L (aromatherapy massage with lavender oil, test), group P (massage with sweet almond oil, placebo', 'Aromatherapy massage with lavender oil', 'aromatherapy massage with lavender oil']","['pain intensity and maximal mouth opening (MMO', 'greatest MMO values', 'lowest pain values']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C2585844', 'cui_str': 'Aromatherapy massage'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",91.0,0.063587,"For VAS, group L revealed the lowest pain values at T1 (2) and T2 (2) ( p  < 0.001).
","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Benli', 'Affiliation': 'Faculty of Dentistry, Department of Prosthodontics, Istanbul University , Istanbul, Turkey.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Olson', 'Affiliation': 'Department of Biology and Marine Biology, University of North Carolina Wilmington , Wilmington, NC, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huck', 'Affiliation': ""Faculty of Medicine, Strasbourg, France, INSERM, UMR 1260 'Osteoarticular and Dental Regenerative Nanomedicine' , Strasbourg, France.""}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'Dental Materials Unit, Center for Dental and Oral Medicine Clinic for Fixed and Removable Prosthodontics and Dental Materials Science, University of Zurich , Zurich, Switzerland.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2020.1819067']
1995,32893750,Three-dimensional kinematics analysis of blind football kicking.,"The purpose of this study was to identify critical technical points that lead to increased ball speed in a maximal toe kick with no run-up (a 'static kick') in blind football. Six visually impaired male players and eight sighted male players participated in the experiment. All participants wore a blindfold to fully remove visual information and performed the static kick. The motion was captured three-dimensionally using an optical motion analysis system. Our results demonstrated that ball speed, maximum linear velocity of the kicking-side thigh, and maximum angular velocity of the kicking-side shank for the sighted player group were significantly greater than those for the visually impaired player group. The sighted players tended to perform the static kick in a similar motion pattern, which was characterised by a backwards rotation of the torso to adequately extend the kicking-side hip joint during the back-swing phase and a stable posture of the lower torso on the frontal plane during the forward-swing phase. This motion pattern is critical to both acceleration of the kicking-side foot and orientation of the foot for a more precise ball contact position.",2020,"The sighted players tended to perform the static kick in a similar motion pattern, which was characterised by a backwards rotation of the torso to adequately extend the kicking-side hip joint during the back-swing phase and a stable posture of the lower torso on the frontal plane during the forward-swing phase.",['Six visually impaired male players and eight sighted male players'],[],"['ball speed, maximum linear velocity of the kicking-side thigh, and maximum angular velocity of the kicking-side shank']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0444675', 'cui_str': 'Shank'}]",6.0,0.0192658,"The sighted players tended to perform the static kick in a similar motion pattern, which was characterised by a backwards rotation of the torso to adequately extend the kicking-side hip joint during the back-swing phase and a stable posture of the lower torso on the frontal plane during the forward-swing phase.","[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sakuma', 'Affiliation': 'Faculty of Health Science, Tsukuba University of Technology , Tsukuba, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Health Science, Tsukuba University of Technology , Tsukuba, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Faculty of Health Science, Tsukuba University of Technology , Tsukuba, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Matsui', 'Affiliation': 'Faculty of Health Science, Tsukuba University of Technology , Tsukuba, Japan.'}, {'ForeName': 'Yasuto', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Sport Management, Faculty of Business and Public Administration, Sakushin Gakuin University , Utsunomiya, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Faculty of Medical and Health Sciences, Tsukuba International University , Tsuchiura, Japan.'}]",Sports biomechanics,['10.1080/14763141.2020.1787499']
1996,32893767,Effects of a home-based exercise program on mental health for caregivers of relatives with dementia: a randomized controlled trial.,"OBJECTIVE


This study was aimed to evaluate the effectiveness of a home-based physical exercise program on participants' mental health: psychological symptoms, depression, and burden of female informal caregivers.
DESIGN AND PARTICIPANTS


In a randomized controlled trial, a sample of 48 female informal primary caregivers completed the entire study, 25 were randomly allocated to the intervention group (IG), and 23 participants to the control group (CG).
INTERVENTION


Participants in the IG performed two 60-minute-long physical exercise sessions per week (36 weeks) that were supervised by a personal trainer at caregivers' home during 9 months. The CG continued their habitual leisure-time activities.
MEASUREMENTS


Subjective burden was assessed by the Zarit Burden Interview. The risk of depression was measured by the Geriatric Depression Scale Short Form 15-item version, and psychological symptoms were evaluated by the Symptom Check List-90-Revised (SCL-90-R). All participants were evaluated at baseline and at the end of the intervention.
RESULTS


A promising positive impact of the intervention on caregivers' subjective burden and risk of depression was found in the IG. In addition, no significant between-group differences were found in any of nine subscales scores of the SCL-90-R. Finally, care recipients' level of functional independence and area of residence were found to be predictors of the promising positive impact on caregivers' subjective burden and risk of depression.
CONCLUSIONS


The present home-based physical exercise intervention that was individually implemented has shown promising results to reduce subjective burden and risk of depression in female caregivers of relatives with dementia. However, future research efforts should elucidate both the particular dose of physical exercise and the particular duration of the intervention that are required to obtain the expected significant positive impact. Finally, future inclusion of psychological approaches, besides physical exercise, might help reduce female caregivers' psychological symptoms.",2020,"In addition, no significant between-group differences were found in any of nine subscales scores of the SCL-90-R.","['48 female informal primary caregivers completed the entire study, 25 were randomly allocated to the intervention group (IG), and 23 participants to the', 'female caregivers of relatives with dementia', ""participants' mental health: psychological symptoms, depression, and burden of female informal caregivers"", 'caregivers of relatives with dementia']","['SCL-90-R', 'home-based physical exercise program', 'physical exercise intervention', '60-minute-long physical exercise sessions', 'control group (CG', 'home-based exercise program']","[""caregivers' subjective burden and risk of depression"", 'risk of depression', 'mental health', 'Geriatric Depression Scale Short Form 15-item version, and psychological symptoms']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",25.0,0.065531,"In addition, no significant between-group differences were found in any of nine subscales scores of the SCL-90-R.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Madruga', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Gozalo', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Prieto', 'Affiliation': 'University School of Tourism and Education, University of Salamanca, Ávila, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Rohlfs Domínguez', 'Affiliation': 'Department of Psychology and Anthropology, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Narcís', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Cáceres, Spain.'}]",International psychogeriatrics,['10.1017/S104161022000157X']
1997,32893790,Bubble Nasal Continuous Positive Airway Pressure (bCPAP) versus Control in Neonates with Respiratory Distress.,"OBJECTIVE


To compare the effectiveness of bubble continuous positive airway pressure (bCPAP) and oxygen inhalation via nasal cannula in neonates presenting with respiratory distress, using Silverman Anderson Retraction Score (SARS).
STUDY DESIGN


Randomised clinical trial.
PLACE AND DURATION OF STUDY


Department of Paediatrics, Unit-1, KEMU/Mayo Hospital, Lahore, Pakistan, from April 2017 to June 2018.
METHODOLOGY


A total of 120 neonates fulfilling inclusion and exclusion criteria were enrolled and were randomly allocated in two groups: Group A and Group B. In group A, neonates were given bCPAP for respiratory support, while neonates in group B were given nasal oxygen as control group. Neonates in both groups were followed for 48 hours. The effectiveness was determined by the reduction in SARS, up to or less than score 3, at the end of a 48-hour period. Data were collected and analysed by SPSS version 20.0. P-value ≤0.05 was taken as significant.
RESULTS


In Group A, effectiveness was found to be 93.3%, and in Group B effectiveness was 71.7% (p = 0.003). Median reduction in SARS from 00 to 48 hours, in group A (bCPAP) was 4 (4 - 5) while in group B (control), it was 3 (2 - 3); statistically significant (p <0.001).
CONCLUSION


Bubble CPAP was more effective than nasal oxygen alone, in treatment of respiratory distress among neonates. This study suggested that bCPAP should be used more frequently in NICUs of Pakistan to reduce burden of neonatal morbidity due to respiratory distress. Key Words: Bubble CPAP, Respiratory distress, Neonates, Silverman Anderson Retraction Score.",2020,"In Group A, effectiveness was found to be 93.3%, and in Group B effectiveness was 71.7% (p = 0.003).","['neonates presenting with respiratory distress, using Silverman Anderson Retraction Score (SARS', 'Neonates with Respiratory Distress', '120 neonates fulfilling inclusion and exclusion criteria']","['Bubble Nasal Continuous Positive Airway Pressure (bCPAP', 'bCPAP', 'bubble continuous positive airway pressure (bCPAP) and oxygen inhalation via nasal cannula']","['Median reduction in SARS', 'Bubble CPAP, Respiratory distress, Neonates, Silverman Anderson Retraction Score']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]",,0.076486,"In Group A, effectiveness was found to be 93.3%, and in Group B effectiveness was 71.7% (p = 0.003).","[{'ForeName': 'Tehreem', 'Initials': 'T', 'LastName': 'Fatima', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Haroon', 'Initials': 'MH', 'LastName': 'Hamid', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Abdul Ahad', 'Initials': 'AA', 'LastName': 'Jamshaid', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Areeba', 'Initials': 'A', 'LastName': 'Wasim', 'Affiliation': 'Department of Paediatric Medicine, King Edward Medical University, Lahore, Pakistan.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.08.805']
1998,32893836,Effect of Green Banana (Musa paradisiaca) on Recovery in Children With Acute Watery Diarrhea With No Dehydration - A Randomized Controlled Trial.,"BACKGROUND


Cooked green banana (Musa paradisiaca) has been observed to be useful in reducing the duration of diarrheal illness in children.
OBJECTIVE


To evaluate whether supplementation of cooked green banana shortens the duration of diarrhea in children with acute watery diarrhea with no dehydration.
STUDY DESIGN


Open label randomized controlled trial.
PARTICIPANTS


Consecutive children aged 9 months to 5 years who presented with acute watery diarrhea within 48 hours of onset of illness with no dehydration.
INTERVENTION


Children in the control group received standard care, while those in the intervention group received cooked green banana in addition to standard care under supervision in the hospital for 72 hours, and then continued at home until diarrhea stopped or 14th day of illness, whichever is earlier.
OUTCOME MEASURES


Proportion of children who improved at 72 hours of intervention (passing formed stools with normal frequency) was considered as the primary outcome and the incidence of complications such as dehydration, persistent diarrhea and secondary lactose intolerance were evaluated as the secondary outcomes.
RESULTS


The proportion of children who recovered within 72 hours was significantly higher (62.4%) in the green banana group compared to the control group (47.2%) [RR 1.3 (95% CI 1.05-1.8), NNT = 7].The number of children with complications such as dehydration and persistent diarrhea was also significantly less in the intervention group.
CONCLUSIONS


Supplementation of cooked green banana in the diet of children with acute watery diarrhea with no dehydration hastens their recovery.",2020,"The proportion of children who recovered within 72 hours was significantly higher (62.4%) in the green banana group compared to the control group (47.2%) [RR 1.3 (95% CI 1.05-1.8), NNT = 7].The number of children with complications such as dehydration and persistent diarrhea was also significantly less in the intervention group.
","['children with acute watery diarrhea with no dehydration hastens their recovery', 'Children With Acute Watery Diarrhea With No', 'children', 'children with acute watery diarrhea with no dehydration', 'Consecutive children aged 9 months to 5 years who presented with acute watery diarrhea within 48 hours of onset of illness with no dehydration']","['cooked green banana', 'Supplementation of cooked green banana', 'Cooked green banana (Musa paradisiaca', 'cooked green banana in addition to standard care under supervision', 'standard care', 'Green Banana (Musa paradisiaca']","['proportion of children who recovered within 72 hours', 'incidence of complications such as dehydration, persistent diarrhea and secondary lactose intolerance', 'duration of diarrhea', 'dehydration and persistent diarrhea']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0239182', 'cui_str': 'Watery diarrhoea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0277793', 'cui_str': 'Onset of illness'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0004722', 'cui_str': 'Banana'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0445059', 'cui_str': 'Musa'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0268183', 'cui_str': 'Acquired lactase deficiency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0975597,"The proportion of children who recovered within 72 hours was significantly higher (62.4%) in the green banana group compared to the control group (47.2%) [RR 1.3 (95% CI 1.05-1.8), NNT = 7].The number of children with complications such as dehydration and persistent diarrhea was also significantly less in the intervention group.
","[{'ForeName': 'Dhandapany', 'Initials': 'D', 'LastName': 'Gunasekaran', 'Affiliation': 'Department of Pediatrics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India. Correspondence to: Dr Dhandapany Gunasekaran, Professor, Department of Pediatrics, JIPMER, Puducherry, India. drguna007@gmail.com.'}, {'ForeName': 'Anandhi', 'Initials': 'A', 'LastName': 'Chandramohan', 'Affiliation': 'Department of Pediatrics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Kadirvel', 'Initials': 'K', 'LastName': 'Karthikeyan', 'Affiliation': 'Department of Pediatrics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Banupriya', 'Initials': 'B', 'LastName': 'Balasubramaniam', 'Affiliation': 'Department of Pediatrics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Podhini', 'Initials': 'P', 'LastName': 'Jagadeesan', 'Affiliation': 'Department of Pediatrics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}, {'ForeName': 'Palanisamy', 'Initials': 'P', 'LastName': 'Soundararajan', 'Affiliation': 'Department of Pediatrics, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.'}]",Indian pediatrics,[]
1999,32894044,"Effects of continuous infusion of phenylephrine vs. norepinephrine on parturients and fetuses under LiDCOrapid monitoring: a randomized, double-blind, placebo-controlled study.","BACKGROUND


Hypotension following spinal anesthesia (SA) during cesarean delivery (CD) occurs commonly and is related with maternal and fetal complications. Norepinephrine infusion is increasingly used for prevention of post-SA hypotension; however, its effects as compared to the traditional phenylephrine infusion remain unclear. This study aimed to compare the effects of phenylephrine and norepinephrine administered as continuous infusion during elective CD on maternal hemodynamic parameters and maternal and fetal outcomes.
METHODS


This prospective, single-center, randomized, controlled study included 238 consecutive term parturients who underwent CD from February 2019 to October 2019. They were randomized to receive continuous infusion of 0.25 μg/kg/min phenylephrine, 0.05 μg/kg/min norepinephrine, or placebo. Hemodynamic monitoring was performed at 10 time points using LiDCOrapid. We analyzed umbilical vein (UV), umbilical artery (UA), and peripheral vein (PV) blood gas indexes and recorded intraoperative complications.
RESULTS


In phenylephrine group, the systolic blood pressure (SBP) remain during the whole operation. Compared to the control group, phenylephrine, but not norepinephrine, significantly increased the systemic vascular resistance (SVR) to counteract the SA-induced vasodilatation, 3 min following norepinephrine/phenylephrine/LR administration (T4): 957.4 ± 590.3 vs 590.1 ± 273.7 (P < 0.000001); 5 min following norepinephrine/phenylephrine/LR administration (T5): 1104 ± 468.0 vs 789.4 ± 376.2 (P = 0.000002). at the time of incision (T6): 1084 ± 524.8 vs 825.2 ± 428.6 (P = 0.000188). Parturients in the phenylephrine group had significantly lower UV (1.91 ± 0.43) (P = 0.0003) and UA (2.05 ± 0.61) (P = 0.0038) lactate level compared to controls. Moreover, the UV pH value was higher in the phenylephrine than in the control group7.37 ± 0.03(P = 0.0013). Parturients had lower incidence of nausea, tachycardia, hypotension in phenylephrine group.
CONCLUSIONS


In this dataset, continuous phenylephrine infusion reduced the incidence of SA-induced hypotension, ameliorated SVR, while decreasing overall maternal complications. Phenylephrine infusions are considered the better choice during CD because of the significant benefit to the fetus.
TRIAL REGISTRATION


Clinicaltrial.gov Registry, NCT03833895 , Registered on 1 February 2019.",2020,Parturients in the phenylephrine group had significantly lower UV (1.91 ± 0.43) (P = 0.0003) and UA (2.05 ± 0.61),"['parturients and fetuses under LiDCOrapid monitoring', '238 consecutive term parturients who underwent CD from February 2019 to October 2019']","['phenylephrine and norepinephrine', 'norepinephrine/phenylephrine', 'placebo', 'phenylephrine vs. norepinephrine', 'continuous infusion of 0.25\u2009μg/kg/min phenylephrine, 0.05\u2009μg/kg/min norepinephrine, or placebo', 'phenylephrine', 'Phenylephrine', 'spinal anesthesia (SA', 'Norepinephrine']","['nausea, tachycardia, hypotension', 'overall maternal complications', 'incidence of SA-induced hypotension, ameliorated SVR', 'lactate level', 'umbilical vein (UV), umbilical artery (UA), and peripheral vein (PV) blood gas indexes and recorded intraoperative complications', 'systolic blood pressure (SBP', 'UV pH value', 'maternal hemodynamic parameters and maternal and fetal outcomes', 'lower UV', 'systemic vascular resistance (SVR']","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0041632', 'cui_str': 'Structure of umbilical artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]",238.0,0.247746,Parturients in the phenylephrine group had significantly lower UV (1.91 ± 0.43) (P = 0.0003) and UA (2.05 ± 0.61),"[{'ForeName': 'Kunpeng', 'Initials': 'K', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Xuexin', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Shanxi provincial People's Hospital, Taiyuan, 030000, Shanxi, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Fengying', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.'}, {'ForeName': 'Tianlong', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China. w_tl5595@hotmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01145-0']
2000,32894073,First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial.,"BACKGROUND


In recent years it has become clear that fetal anomalies can already be detected at the end of the first trimester of pregnancy by two-dimensional (2D) ultrasound. This is why increasingly in developed countries the first trimester anomaly scan is being offered as part of standard care. We have developed a Virtual Reality (VR) approach to improve the diagnostic abilities of 2D ultrasound. Three-dimensional (3D) ultrasound datasets are used in VR assessment, enabling real depth perception and unique interaction. The aim of this study is to investigate whether first trimester 3D VR ultrasound is of additional value in terms of diagnostic accuracy for the detection of fetal anomalies. Health-related quality of life, cost-effectiveness and also the perspective of both patient and ultrasonographer on the 3D VR modality will be studied.
METHODS


Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion. This is a randomized controlled trial with two intervention arms. The control group receives 'care as usual': a second trimester 2D advanced ultrasound examination. The intervention group will undergo an additional first trimester 2D and 3D VR ultrasound examination. Following each examination participants will fill in validated questionnaires evaluating their quality of life and healthcare related expenses. Participants' and ultrasonographers' perspectives on the 3D VR ultrasound will be surveyed. The primary outcome will be the detection of fetal anomalies. The additional first trimester 3D VR ultrasound examination will be compared to 'care as usual'. Neonatal or histopathological examinations are considered the gold standard for the detection of congenital anomalies. To reach statistical significance and 80% power with a detection rate of 65% for second trimester ultrasound examination and 70% for the combined detection of first trimester 3D VR and second trimester ultrasound examination, a sample size of 2800 participants is needed.
DISCUSSION


First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations. Results of this study will provide policymakers and healthcare professionals with the highest level of evidence for cost-effectiveness of first trimester ultrasound using a 3D VR approach.
TRIAL REGISTRATION


Dutch Trial Registration number NTR6309 , date of registration 26 January 2017.",2020,First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations.,['Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion'],"[""care as usual': a second trimester 2D advanced ultrasound examination""]","['Health-related quality of life, cost-effectiveness', 'detection of fetal anomalies']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0242786', 'cui_str': 'High risk pregnancy'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",2800.0,0.142923,First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations.,"[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Pietersma', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A G M G J', 'Initials': 'AGMGJ', 'LastName': 'Mulders', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Moolenaar', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'M G M', 'Initials': 'MGM', 'LastName': 'Hunink', 'Affiliation': 'Department of Epidemiology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A H J', 'Initials': 'AHJ', 'LastName': 'Koning', 'Affiliation': 'Department of Pathology, Clinical Bioinformatics Unit, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Department of Biostatistics, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'A T J I', 'Initials': 'ATJI', 'LastName': 'Go', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'E A P', 'Initials': 'EAP', 'LastName': 'Steegers', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rousian', 'Affiliation': 'Department of Obstetrics and Gynecology, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands. m.rousian@erasmusmc.nl.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03180-8']
2001,32894074,Effect of nipple shield use on milk removal: a mechanistic study.,"BACKGROUND


Concerns about reduced milk transfer with nipple shield (NS) use are based on evidence from studies with methodological flaws. Milk removal during breastfeeding can be impacted by infant and maternal factors other than NS use. The aim of this study was to control electric breast pump vacuum strength, pattern and duration across multiple study sessions to determine if NS use reduces milk removal from the breast.
METHODS


A within-subject study with two groups of breastfeeding mothers (infants < 6 months) were recruited; Control Group (CG): no breastfeeding difficulties; Pain Group (PG) used NS for persistent nipple pain. Mothers completed three randomised 15 min pumping sessions using the Symphony vacuum curve (Medela AG); no NS, fitted NS, and a small NS. Sessions were considered valid where the applied vacuum was within 20 mmHg of the set vacuum. Milk removal was considered as pumped milk volume, and also percentage of available milk removed (PAMR), which is calculated as the pumped volume divided by the estimated milk volume stored in the breast immediately prior to pumping.
RESULTS


Of 62 sessions (all: n = 31 paired sessions) a total of 11 paired sessions from both PG (n = 03) and CG (n = 08) were valid (subset) with and without a fitted NS. Only 2 small shield sessions were valid and so all small shield measurements were excluded. Both pumped volumes and PAMR were significantly lower with NS use for all data but not for subset data. (All: Volume and PAMR median: no NS: 76.5 mL, 69%, Fitted NS: 32.1 mL, 41% respectively (volume p = 0.002, PAMR p = 0.002); Subset: Volume and PAMR median: no NS: 83.8 mL, 72%; Fitted NS: 35.2 mL, 40% (volume p = 0.111 and PAMR p = 0.045). The difference in PAMR, but not volume, was statistically significant when analysed by linear mixed modelling. A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
CONCLUSIONS


This experimental data suggests that nipple shield use may reduce milk removal. Close clinical monitoring of breastfeeding mothers using nipple shields is warranted.",2020,"A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
",['breastfeeding mothers (infants\u2009<\u20096 months) were recruited'],"['Control Group (CG): no breastfeeding difficulties; Pain Group (PG) used NS', 'Fitted NS']","['milk removal', 'PAMR']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998999', 'cui_str': 'Difficulty performing breast-feeding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183252', 'cui_str': 'Nipple shield'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]",,0.052731,"A decrease of 10 mmHg was associated with a 4.4% increase in PAMR (p = 0.017).
","[{'ForeName': 'Viviane Silva', 'Initials': 'VS', 'LastName': 'Coentro', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}, {'ForeName': 'Sharon Lisa', 'Initials': 'SL', 'LastName': 'Perrella', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia. sharon.perrella@uwa.edu.au.'}, {'ForeName': 'Ching Tat', 'Initials': 'CT', 'LastName': 'Lai', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}, {'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Rea', 'Affiliation': 'Mathematics and Statistics, School of Engineering and Information Technology, Murdoch University, 90 South Street, Western Australia, 6150, Murdoch, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, Faculty of Health and Medical Sciences, Population and Global Health, The University of Western Australia, M431, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}, {'ForeName': 'Donna Tracy', 'Initials': 'DT', 'LastName': 'Geddes', 'Affiliation': 'School of Molecular Sciences, Faculty of Science, The University of Western Australia, M310, 35 Stirling Highway, Western Australia, 6009, Crawley, Australia.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03191-5']
2002,32894075,"Evaluating a frontostriatal working-memory updating-training paradigm in Parkinson's disease: the iPARK trial, a double-blinded randomized controlled trial.","BACKGROUND


Cognitive decline and dementia are common in Parkinson's disease (PD). Cognitive deficits have been linked to the depletion of dopamine in the nigrostriatal pathway, but pharmacological treatments for PD have little evidence of improving or delaying cognitive decline. Therefore, exploring non-pharmacological treatment options is important. There have been some promising results of cognitive training interventions in PD, especially for improvements in working memory and executive functions. Yet, existing studies are often underpowered, lacking appropriate control condition, long term follow-up, a thorough description of the intervention and characteristics of the participants. Working memory updating training has previously shown to increase striatal activation in healthy young and old participants as well as dopaminergic neurotransmission in healthy young participants. In the light of dopamine dysfunction in PD, with negative effects on both motor and cognitive functions it is of interest to study if an impaired striatal system can be responsive to a non-invasive, non-pharmacological intervention.
METHODS AND DESIGN


The iPARK trial is a double-blinded, randomized controlled trial with a parallel-group design that aims to recruit 80 patients with PD (during the period 02/2017-02/2023). Included patients need to have PD, Hoehn and Yahr staging I-III, be between 45 to 75 years of age and not have a diagnosis of dementia. All patients will undergo 30 sessions (6-8 weeks) of web-based cognitive training performed from home. The target intervention is a process-based training program targeting working memory updating. The placebo program is a low dose short-term memory program. A battery of neuropsychological tests and questionnaires will be performed before training, directly after training, and 16 weeks after training.
DISCUSSION


We expect that the iPARK trial will provide novel and clinically useful information on whether updating training is an effective cognitive training paradigm in PD. Further, it will hopefully contribute to a better understanding of cognitive function in PD and provide answers regarding cognitive plasticity as well as determining critical factors for a responsive striatal system.
TRIAL REGISTRATION


Clinicaltrials.gov registry number: NCT03680170 , registry name: ""Cognitive Training in Parkinson's Disease: the iPARK study"", retrospectively registered on the 21st of September 2018. The inclusion of the first participant was the 1st of February 2017.",2020,Working memory updating training has previously shown to increase striatal activation in healthy young and old participants as well as dopaminergic neurotransmission in healthy young participants.,"[""Parkinson's disease (PD"", ""Parkinson's disease"", 'Included patients need to have PD, Hoehn and Yahr staging I-III, be between 45 to 75\u2009years of age and not have a diagnosis of dementia', 'healthy young participants', 'healthy young and old participants', '80 patients with PD (during the period 02/2017-02/2023']","['placebo', 'frontostriatal working-memory updating-training paradigm', 'Working memory updating training', 'Cognitive Training']",['striatal activation'],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0332305', 'cui_str': 'With staging'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]",[],80.0,0.126612,Working memory updating training has previously shown to increase striatal activation in healthy young and old participants as well as dopaminergic neurotransmission in healthy young participants.,"[{'ForeName': 'Magdalena Eriksson', 'Initials': 'ME', 'LastName': 'Domellöf', 'Affiliation': 'Department of Psychology, Umeå University, Umeå, Sweden. magdalena.domellof@umu.se.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Walton', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Umeå Center for Functional Brain Imaging (UFBI), Umeå University, Umeå, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bäckström', 'Affiliation': 'Department of Clinical Science, Neuroscience Umeå University, Umeå, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Josefsson', 'Affiliation': 'Center for Demographic and Aging Research (CEDAR), Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Forsgren', 'Affiliation': 'Department of Clinical Science, Neuroscience Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stigsdotter Neely', 'Affiliation': 'Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden. anna.neely@kau.se.'}]",BMC neurology,['10.1186/s12883-020-01893-z']
2003,32894117,Impacts of contracted endodontic cavities compared to traditional endodontic cavities in premolars.,"BACKGROUND


This study aims to compare the percentage of dentin removed, instrumentation efficacy, root canal filling and load at fracture between contracted endodontic cavities, and traditional endodontic cavities on root canal therapy in premolars.
METHODS


Forty extracted intact human first premolars were imaged with micro-CT and randomly assigned to the contracted endodontic cavity (CEC) or traditional endodontic cavity (TEC) groups. CEC was prepared with the aid of a 3D-printed template, canals were prepared with a 0.04 taper M-Two rotary instrument, and cavities were restored with resin. Specimens were loaded to fracture in an Instron Universal Testing Machine after a fatigue phase. The data were analyzed by the independent samples T test and Mann-Whitney U test, appropriate post hoc tests.
RESULTS


In the premolars tested in vitro, the percentage of dentin removed in the premolars with two dental roots in the CEC group (3.85% ± 0.42%) was significantly smaller (P < 0.05) than in the TEC group (4.94% ± 0.5%). The untouched canal wall (UCW) after instrumentation for TECs (16.43% ± 6.56%) was significantly lower (P < .05) than the UCW (24.42% ± 9.19%) for CECs in single-rooted premolars. No significant differences were observed in the increased canal volume and surface areas in premolars between the TEC and CEC groups (P > 0.05). CECs conserved coronal dentin in premolars with two dental roots but no impact on the instrument efficacy. There were no differences between the CEC groups and the TEC groups in the percentage of filling material and voids (P > 0.05). In addition, the mean load at failure of premolars did not significantly differ between the CEC and TEC groups and there was no significant difference in the type of fracture (P > 0.05).
CONCLUSION


The results of this study suggest that CEC could not improve the fracture resistance of the endodontically treated premolars. The instrumentation efficacy and the percentage of filling material did not significantly differ between CECs and TECs in premolars.",2020,The instrumentation efficacy and the percentage of filling material did not significantly differ between CECs and TECs in premolars.,"['premolars', 'Forty extracted intact human first premolars were imaged with']","['micro-CT', 'CEC', 'TEC', 'contracted endodontic cavities', 'contracted endodontic cavity (CEC) or traditional endodontic cavity (TEC']","['percentage of filling material and voids', 'type of fracture', 'fracture resistance', 'instrumentation efficacy and the percentage of filling material', 'percentage of dentin', 'mean load at failure of premolars', 'canal volume and surface areas']","[{'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C2350281', 'cui_str': 'MicroCT'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0440137', 'cui_str': 'Filling material'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",40.0,0.0319978,The instrumentation efficacy and the percentage of filling material did not significantly differ between CECs and TECs in premolars.,"[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Zhengmao', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Basic Science of Stomatology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Bingpeng', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Orthodontic, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral Function and Prosthetic Dentistry, College of Dental Science, Radboud University Nijmegen Medical Centre, Philips van Leydenlaan 25, 6525EX, Nijmegen, The Netherlands.'}, {'ForeName': 'Qianzhou', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China.'}, {'ForeName': 'Xuechao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Endodontology, Affiliated Stomatology Hospital of Guangzhou Medical University, Guangzhou key Laboratory of Basic and Applied Research of Oral Regenerative Medicine, Guangzhou, 510182, Guangdong, China. xcyang@gzhmu.edu.cn.'}]",BMC oral health,['10.1186/s12903-020-01237-w']
2004,32894140,Supplement with whey protein hydrolysate in contrast to carbohydrate supports mitochondrial adaptations in trained runners.,"BACKGROUND


Protein supplementation has been suggested to augment endurance training adaptations by increasing mixed muscle and myofibrillar protein synthesis and lean body mass. However, a potential beneficial effect on mitochondrial adaptations is yet to be clarified. The aim of the present study was to investigate the effect of consuming whey protein hydrolysate before and whey protein hydrolysate plus carbohydrate (PRO-CHO) after each exercise session during a six-week training period compared to similarly timed intake of isocaloric CHO supplements on biomarkers of mitochondrial biogenesis, VO 2max  and performance in trained runners.
METHODS


Twenty-four trained runners (VO 2max  60.7 ± 3.7 ml O 2  kg - 1  min 1 ) completed a six-week block randomized controlled intervention period, consisting of progressive running training. Subjects were randomly assigned to either PRO-CHO or CHO and matched in pairs for gender, age, VO 2max , training and performance status. The PRO-CHO group ingested a protein beverage (0.3 g kg - 1 ) before and protein-carbohydrate beverage (0.3 g protein kg - 1  and 1 g carbohydrate kg - 1 ) after each exercise session. The CHO group ingested an energy matched carbohydrate beverage. Resting muscle biopsies obtained pre and post intervention were analyzed for mitochondrial specific enzyme activity and mitochondrial protein content. Subjects completed a 6 K time trial (6 K TT) and a VO 2max  test pre, midway (only 6 K TT) and post intervention.
RESULTS


Following six weeks of endurance training Cytochrome C (Cyt C) protein content was significantly higher in the PRO-CHO group compared to the CHO group (p < 0.05), with several other mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1)) following a similar, but non-significant pattern (p = 0.07-0.14). β-hydroxyacyl-CoA dehydrogenase (HAD) activity was significantly lower after training in the CHO group (p < 0.01), but not in the PRO-CHO group (p = 0.24). VO 2max  and 6 K TT was significantly improved after training with no significant difference between groups.
CONCLUSION


Intake of whey PRO hydrolysate before and whey PRO hydrolysate plus CHO after each exercise session during a six-week endurance training period may augment training effects on specific mitochondrial proteins compared to intake of iso-caloric CHO but does not alter VO 2max  or 6 K TT performance.
TRIAL REGISTRATION


clinicaltrials.gov , NCT03561337 . Registered 6 June 2018 - Retrospectively registered.",2020,"Following six weeks of endurance training Cytochrome C (Cyt C) protein content was significantly higher in the PRO-CHO group compared to the CHO group (p < 0.05), with several other mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1)) following a similar, but non-significant pattern (p = 0.07-0.14).","['Twenty-four trained runners (VO 2max  60.7\u2009±\u20093.7', 'trained runners']","['PRO-CHO or CHO', 'Supplement with whey protein hydrolysate', 'isocaloric CHO supplements', 'consuming whey protein hydrolysate before and whey protein hydrolysate plus carbohydrate (PRO-CHO', 'whey PRO hydrolysate', 'ml O 2  kg -\u20091 \u2009min 1 ) completed a six-week block randomized controlled intervention period, consisting of progressive running training']","['biomarkers of mitochondrial biogenesis, VO 2max  and performance', 'VO 2max  and 6\u2009K TT', 'mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1', 'β-hydroxyacyl-CoA dehydrogenase (HAD) activity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4517696', 'cui_str': '3.7'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494456', 'cui_str': 'Mitochondrial Biogenesis'}, {'cui': 'C0949610', 'cui_str': 'Mitochondrial Protein'}, {'cui': 'C0038615', 'cui_str': 'Succinate dehydrogenase'}, {'cui': 'C0010760', 'cui_str': 'Cytochrome c oxidase'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C1506024', 'cui_str': 'Pore Forming Protein VDAC'}, {'cui': 'C0109272', 'cui_str': 'hsp60 Protein'}, {'cui': 'C0084178', 'cui_str': 'prohibitin'}, {'cui': 'C0009226', 'cui_str': 'Coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.038213,"Following six weeks of endurance training Cytochrome C (Cyt C) protein content was significantly higher in the PRO-CHO group compared to the CHO group (p < 0.05), with several other mitochondrial proteins (Succinate dehydrogenase (SDHA), Cytochrome C oxidase (COX-IV), Voltage-dependent anion channel (VDAC), Heat shock protein 60 (HSP60), and Prohibitin (PHB1)) following a similar, but non-significant pattern (p = 0.07-0.14).","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark. mhan@ph.au.dk.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Oxfeldt', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Larsen', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Lise S', 'Initials': 'LS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Rokkedal-Lausch', 'Affiliation': 'Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Frank V', 'Initials': 'FV', 'LastName': 'De Paoli', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Ørtenblad', 'Affiliation': 'Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Klavs', 'Initials': 'K', 'LastName': 'Madsen', 'Affiliation': 'Section for Sport Sciences, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus C, Denmark.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00376-3']
2005,32894145,Evaluation of the birth plan implementation: a parallel convergent mixed study.,"BACKGROUND


Pregnancy, birth, and motherhood are among the most important events of every woman's life. Training and participation of mothers in the decision-making process of delivery play an essential role in physical as well as psychosocial preparation of the mother. The healthcare system can improve and enhance the level of care by involving the patient in their self-care process. The aim of the present study is to assess the implementation of the birth plan for the first time in Iran in Tabriz city.
METHODS/DESIGN


The present study uses a mixed-method with a parallel convergence approach, including both quantitative and qualitative phases. The quantitative phase is a randomized controlled clinical trial performed on 106 pregnant women, 32-36 weeks of pregnancy, referring to Taleghani educational hospital in Tabriz city. The participants will be assigned into intervention and control groups using a randomized block method. A training session will be held about the items of the birth plan checklist at weeks 32-36 of gestation for the participants in the intervention group, whereby a mother-requested birth plan will be developed. It will then be implemented by the researcher after admitting them to the delivery ward. Also, those in the control group will receive routine care. During and after the delivery, the questionnaire of delivery information, neonatal information, and Delivery Fear Scale (DFS) will be completed. Also, a partogram will be completed for all participants by the researcher. The participants in both groups will be followed up until six weeks post-delivery, whereby the instruments of Childbirth Experience Questionnaire (CEQ2.0), Edinburgh's Postpartum Depression Scale and PTSD Symptom Scale 1 (PSS-I) will be completed six weeks 4-6 weeks postpartum by the researcher through an interview with participants in Taleghani educational hospital. The general linear model and multivariate logistic regression model will be used while controlling the possible confounding variables. The qualitative phase will be performed to explore the women's perception of the effect of the birth plan on childbirth experience within 4-6 weeks postpartum. The sampling will be of a purposeful type on the women who would receive the birth plan and will continue until data saturation. In-depth, semi-structured individual interviews would be used for data collection. The data analysis will be done through content analysis with a conventional approach. The results of the quantitative and qualitative phases will be analyzed separately, and then combined in the interpretation stage.
DISCUSSION


By investigating the effect of implementing the birth plan on the childbirth experience of women as well as other maternal and neonatal outcomes, an evidence-based insight can be offered using a culturally sensitive approach. The presentation of the results obtained from this study using the mixed method may be effective in improving the quality of care provided for women during labor.
TRIAL REGISTRATION


Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N58. Date of registration: July 7, 2020. URL: https://en.irct.ir/user/trial/47007/view.",2020,The qualitative phase will be performed to explore the women's perception of the effect of the birth plan on childbirth experience within 4-6 weeks postpartum.,"['106 pregnant women, 32-36\u2009weeks of pregnancy, referring to Taleghani educational hospital in Tabriz city', 'Iran in Tabriz city']",[],"[""Childbirth Experience Questionnaire (CEQ2.0), Edinburgh's Postpartum Depression Scale and PTSD Symptom Scale"", 'questionnaire of delivery information, neonatal information, and Delivery Fear Scale (DFS']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0522187', 'cui_str': 'Tocophobia'}]",106.0,0.0467964,The qualitative phase will be performed to explore the women's perception of the effect of the birth plan on childbirth experience within 4-6 weeks postpartum.,"[{'ForeName': 'Parivash', 'Initials': 'P', 'LastName': 'Ahmadpour', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mosavi', 'Affiliation': 'Women Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh-Charandabi', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Jahanfar', 'Affiliation': 'Public Health Department, Central Michigan University, Mount Pleasant, MI, USA.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. mirghafourvand@gmail.com.'}]",Reproductive health,['10.1186/s12978-020-00989-6']
2006,32894159,"Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial.","BACKGROUND


The Getting it Right: Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder. This article describes the statistical analysis plan for the GRASP randomised controlled trial.
METHODS/DESIGN


GRASP is a multicentre randomised controlled trial using a 2 × 2 factorial design. Adults aged ≥ 18 years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery, are randomised (centralised computer-generated 1:1:1:1 allocation ratio) to one of four interventions: (1) progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection then best practice advice. The primary outcome is the mean difference in Shoulder Pain and Disability Index (SPADI) total score over 12 months. Secondary outcomes are as follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability. Here, we describe in detail the following: sample size calculation, descriptive statistics of the primary and secondary outcomes, statistical models used for the analysis of the main outcomes, handling of missing data, planned sensitivity and subgroup analyses. This pre-specified statistical analysis plan was written and submitted without prior knowledge of the trial results.
DISCUSSION


Publication of the statistical analysis plan for the GRASP trial aims to reduce the risk of outcome reporting bias and increase transparency of the data analysis. Any deviations or changes to the current SAP will be described and justified in the final study report and any results publications.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number ISRCTN16539266 . Registered on 14 June 2016. EudraCT number 2016-002991-28. Registered on 12 June 2016.",2020,"Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.","['Adults aged ≥\u200918\u2009years with a new episode of shoulder pain related to a rotator cuff disorder, not currently receiving physiotherapy or being considered for surgery', 'Right', 'adults with a rotator cuff disorder']","['GRASP', 'Progressive exercise compared with best practice advice, with or without corticosteroid injection', 'progressive exercise (up to 6 physiotherapy sessions), (2) best practice advice (one physiotherapy session), (3) subacromial corticosteroid injection then progressive exercise and (4) subacromial corticosteroid injection', 'progressive exercise compared with best practice advice, with or without corticosteroid injection']","['Addressing Shoulder Pain', 'mean difference in Shoulder Pain and Disability Index (SPADI) total score', 'follows: pain and function SPADI subdomains, health-related quality of life (EuroQol EQ-5D-5L), sleep disturbance, return to activity, global impression of change, health resource use, out-of-pocket expenses and work disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3815933', 'cui_str': 'Uninsured medical expenses'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",,0.256568,"Addressing Shoulder Pain (GRASP) trial assesses the clinical and cost-effectiveness of individually tailored, progressive exercise compared with best practice advice, with or without corticosteroid injection, in adults with a rotator cuff disorder.","[{'ForeName': 'Ioana R', 'Initials': 'IR', 'LastName': 'Marian', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK. ioana.marian@csm.ox.ac.uk.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Oxford NIHR Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Cureton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Rehabilitation Research, Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Old Road, Oxford, OX3 7LD, UK.'}]",Trials,['10.1186/s13063-020-04704-5']
2007,32894190,"Acupuncture treatment for carotid atherosclerotic plaques: study protocol for a pilot randomized, single blinded, controlled clinical trial.","BACKGROUND


Carotid atherosclerosis disease (CAD) is generally associated with the occurrence of cardiovascular and cerebrovascular accidents. However, CAD has not been taken seriously enough in the clinic, which, coupled with the single treatment and prevention of CAD, has led to a generally low level of patient compliance. Therefore, acupuncture is expected to be a safe and effective therapy that can be maintained in the long term for patients with CAD. The study objective is to evaluate the efficiency and reliability of acupuncture to relieve CAD and provide a new therapeutic idea for the clinical treatment of CAD.
METHODS


This is a three-arm randomized clinical trial in China. Three groups (TA, SA, and MC) will be randomly allocated at a 1:1:1 ratio. The study will enrol 105 cervical atherosclerosis plaque patients in total on a voluntary basis, with 35 patients in each group. The treatment will last for 12 weeks, with two treatments per week for twenty-four treatments in total.
RESULTS


Two 3D ultrasound indicators will be measured as the primary outcomes: the total plaque volume (PV) of the carotid artery on each side and the grey-scale median (GSM). The secondary outcomes will include intima-media thickness (IMT), lipid levels, apolipoprotein A-IV level, platelet count (PLT), fibrinogen (FIB), and platelet aggregation rate (PAR). All the outcomes will be assessed before treatment, after treatment, and after a 12-week follow-up period. This study will utilize per-protocol (PP) and intention-to-treat (ITT) analysis principles.
CONCLUSIONS


This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine (no. YF2018-107-01). All data and findings will be provided by the principal investigator via email.
TRIAL REGISTRATION


ChiCTR, ChiCTR1800019259 . Registered on 1 November 2018-retrospectively registered, http://www.chictr.org.cn/index.aspx.",2020,"This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups.
","['patients with CAD', '105 cervical atherosclerosis plaque patients in total on a voluntary basis, with 35 patients in each group', 'carotid atherosclerotic plaques']","['acupuncture (TA), sham acupuncture (SA), and medication (MC', 'Acupuncture treatment', 'acupuncture']","['intima-media thickness (IMT), lipid levels, apolipoprotein A-IV level, platelet count (PLT), fibrinogen (FIB), and platelet aggregation rate (PAR', 'total plaque volume (PV) of the carotid artery on each side and the grey-scale median (GSM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0052181', 'cui_str': 'Apolipoprotein A-IV'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C1269776', 'cui_str': 'Gray color'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",105.0,0.133557,"This trial is to evaluate the efficacy and reliability of acupuncture in relieving carotid atherosclerotic plaques by establishing acupuncture (TA), sham acupuncture (SA), and medication (MC) groups.
","[{'ForeName': 'Junhe', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Lingcui', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Ultrasonography Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Huitao', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': 'The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Ultrasonography Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Siting', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Ultrasonography Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Zhiqi', 'Initials': 'Z', 'LastName': 'Qi', 'Affiliation': 'Acupuncture Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Xichang', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Acupuncture Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Shenzhen Bao'an Research Centre for Acupuncture and Moxibustion, Shenzhen, China. zpszba@163.com.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'The Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China. fuwenbin@139.com.'}]",Trials,['10.1186/s13063-020-04709-0']
2008,32894227,Culprit lesion location and outcomes in patients with multi-vessel disease and infarct-related cardiogenic shock. A core laboratory analysis of the CULPRIT-SHOCK trial.,"AIMS


Critical culprit lesion locations (CCLL) such as left main (LM) and proximal left anterior descending (LAD) are associated with worse clinical outcome in myocardial infarction without cardiogenic shock (CS). We aimed to assess whether CCLL identifies a subgroup of patients at poorer prognosis when presenting with CS.
METHODS AND RESULTS


In the CULPRIT-SHOCK trial, a core-laboratory reviewed all coronary angiograms to identify CCLL. CCLL was defined as a culprit lesion realizing a &gt;70% diameter stenosis of LM, LM equivalent (&gt;70% diameter stenoses of both proximal LAD and proximal circumflex), proximal LAD or, last remaining vessel. We evaluated the primary study endpoint of the CULPRIT-SHOCK trial according to CCLL. A total of 269 (43%) out of 626 patients eligible for this analysis had a CCLL. Death or renal replacement therapy within 30 days, death within 30 days and within 1 year were significantly higher in CCLL than in non-CCLL group (58.4% vs. 43.4%, p&lt;0.001, 55.8% vs . 39.5%, p&lt;0.001, 61.0% vs. 44.5%, p&lt;0.001, respectively). It was consistent after adjustment for baseline and angiographic characteristics. No interaction with the randomization group (culprit lesion-only or immediate multivessel PCI) was found.
CONCLUSIONS


CCLL is frequent in CS and independently associated with worse clinical outcome irrespective of the revascularization strategy.",2020,"Death or renal replacement therapy within 30 days, death within 30 days and within 1 year were significantly higher in CCLL than in non-CCLL group (58.4% vs. 43.4%, p&lt;0.001, 55.8% vs .","['A total of 269 (43%) out of 626 patients eligible for this analysis had a CCLL', 'myocardial infarction without cardiogenic shock (CS', 'patients with multi-vessel disease and infarct-related cardiogenic shock']",['CCLL'],"['CCLL', 'Death or renal replacement therapy']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",626.0,0.212562,"Death or renal replacement therapy within 30 days, death within 30 days and within 1 year were significantly higher in CCLL than in non-CCLL group (58.4% vs. 43.4%, p&lt;0.001, 55.8% vs .","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie (AP-HP), Paris, France.'}, {'ForeName': 'Olvier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': ''}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Farhan', 'Affiliation': ''}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': ''}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': ''}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Hage', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': ''}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ''}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00561']
2009,32894238,Effects of ELDOA and post-facilitation stretching technique on pain and functional performance in patients with piriformis syndrome: A randomized controlled trial.,"BACKGROUND


Piriformis syndrome (PS) is a neuro-muscular condition, which is often underdiagnosed in clinical settings. This study will determine the effects of myofascial stretching Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) and post-facilitation stretching of the piriformis muscle in patients with PS.
OBJECTIVE


We aimed to compare the effects of ELDOA and post-facilitation stretching of the piriformis muscle on pain, muscle length and functional performance in patients with PS.
METHODS


A randomized clinical trial was conducted with 40 PS patients including both males and females, between the ages of 30-70. Patients were randomly assigned to the ELDOA or post-facilitation group after assessments with the Numeric Pain Rating Scale (NPRS), Lower Extremity Functional Scale (LEFS), Piriformis Length Test and Straight Leg Raise (SLR). The assessments were done at baseline and at the end of the sixth week of treatment.
RESULTS


The patients treated with ELDOA demonstrated significant improvement in pain (pre = 7.00 ± 2.75, post = 3.00 ± 1.75), piriformis length (pre = 27.6 ± 5.54, post = 36.8 ± 3.13), SLR (pre = 36.40 ± 7.24, post = 67.5 ± 8.36) and LEFS (pre = 26.90 ± 12.24, post = 58.10 ± 8.62), as compared with the group treated with post-facilitation stretching: pain: pre = 6.00 ± 1.00, post = 2.00 ± 1.50; piriformis length: pre = 28.55 ± 4.03, post = 38.8 ± 2.70; SLR: pre = 40.60 ± 7.48, post = 74.25 ± 5.19, and LEFS: pre = 25.20 ± 7.66, post = 66.30 ± 7.27).
CONCLUSION


It can be concluded that the post-facilitation stretching technique shows more improvement in pain, muscle length, SLR, and LEFS in patients with PS as compared to ELDOA.",2020,"It can be concluded that the post-facilitation stretching technique shows more improvement in pain, muscle length, SLR, and LEFS in patients with PS as compared to ELDOA.","['patients with PS', '40 PS patients including both males and females, between the ages of 30-70', 'patients with piriformis syndrome']","['ELDOA and post-facilitation stretching technique', 'ELDOA', 'myofascial stretching Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) and post-facilitation stretching', 'ELDOA and post-facilitation stretching of the piriformis muscle', 'ELDOA or post-facilitation']","['piriformis length', 'pain, muscle length and functional performance', 'pain, muscle length, SLR, and LEFS', 'pain and functional performance', 'Numeric Pain Rating Scale (NPRS), Lower Extremity Functional Scale (LEFS), Piriformis Length Test and Straight Leg Raise (SLR', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458224', 'cui_str': 'Piriformis syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}]","[{'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",40.0,0.135265,"It can be concluded that the post-facilitation stretching technique shows more improvement in pain, muscle length, SLR, and LEFS in patients with PS as compared to ELDOA.","[{'ForeName': 'Momena', 'Initials': 'M', 'LastName': 'Shahzad', 'Affiliation': ''}, {'ForeName': 'Nazish', 'Initials': 'N', 'LastName': 'Rafique', 'Affiliation': ''}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Shakil-Ur-Rehman', 'Affiliation': ''}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Ali Hussain', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181290']
2010,32894239,The effect of aerobic exercise training on postmenopausal patients with knee osteoarthritis.,"BACKGROUND


Knee osteoarthritis (OA) is a common musculoskeletal problem encountered in the postmenopausal period.
OBJECTIVE


This study aimed to determine the impact of aerobic exercise on functional limitation, exercise tolerance, and performance tests in postmenopausal women with knee OA.
METHODS


A total of 50 women (aged between 48-78) with grade 2-3 knee OA according to the Kellgren-Lawrence radiographic scale were enrolled. OA-specific physical performance tests (40 m Fast-Paced Walk Test (40mFPWT), 30 s Chair Stand Test (30sCST), Stair Climb Test (9-step SCT)), six-minute walk test (6MWT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS) were performed. Fifty patients were randomized to either the treatment or control groups. The treatment group received an additional aerobic exercise training along with a combined physiotherapy program for six weeks. The aerobic exercise program was carried out by the same physiotherapist every weekday (five days) for six weeks. The control group only received a combined physiotherapy program for six weeks.
RESULTS


The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
CONCLUSIONS


Consequently, this study provides an insight into the efficacy of the aerobic exercise program applied along with a combined physiotherapy program in postmenopausal women with knee OA.",2020,"The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
","['postmenopausal patients with knee osteoarthritis', 'Fifty patients', '50 women (aged between 48-78) with grade 2-3 knee OA according to the Kellgren-Lawrence radiographic scale were enrolled', 'postmenopausal women with knee OA']","['combined physiotherapy program', 'additional aerobic exercise training', 'OA-specific physical performance tests (40\xa0m Fast-Paced Walk Test (40mFPWT', 'aerobic exercise', 'aerobic exercise program', 'aerobic exercise training']","['30\xa0s Chair Stand Test (30sCST), Stair Climb Test (9-step SCT)), six-minute walk test (6MWT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS', 'performance tests, WOMAC scores, and the distance covered in 6MWT', 'functional limitation, exercise tolerance, and performance tests', 'VAS scores']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]","[{'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0796149', 'cui_str': 'Scott syndrome'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",50.0,0.040622,"The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
","[{'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Kiliç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Demirgüç', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Sanko University, Gaziantep, Turkey.'}, {'ForeName': 'Saniye Aydoğan', 'Initials': 'SA', 'LastName': 'Arslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Esra Dilek', 'Initials': 'ED', 'LastName': 'Keskin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Müyesser', 'Initials': 'M', 'LastName': 'Aras', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191712']
2011,32894278,A double-bind and randomized trial to evaluate Miltefosine and topical GM-CSF in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil.,"BACKGROUND


The treatment of cutaneous leishmaniasis (CL) in Brazil by pentavalent antimony (Sb v) is associated with a high rate of failure. Oral miltefosine in monotherapy has proven high efficacy in CL caused by L. braziliensis with a cure rate of 75%. A combined treatment with GM-CSF and miltefosine was tested to increase the cure rate and decrease the healing time.
METHODS


This is a randomized and double-blind clinical trial to evaluate the efficacy of miltefosine combined with topical GM-CSF (M+GM) versus miltefosine and placebo (M+P) versus standard Sb v in the treatment of 133 patients with CL caused by L. braziliensis in Bahia, Brazil.
RESULTS


The final cure rate at 180 days after the initiation of treatment was 44.4% in the Sb v group, 76.6% in the M+P group (P= 0.003 versus Sb v), and 75.6% in the M+GM group (P= 0.004 versus Sb v). By survival curve analysis median healing time for cure was 102 for Sb v group and 60 days for both miltefosine groups (P= 0.0009). During the 6 months follow-up period, four relapses were documented, one in the Sb v group (2%), one in the M+P group (2%) and two in the M+GM group (5%). Adverse events were documented in 65% of subjects from Sb v group, 79% of M+GM group and 76% of M+P group.
CONCLUSIONS


Miltefosine is more effective than standard Sb v for the treatment of CL caused by L. braziliensis in Brazil and accelerate the healing time of CL. The association of Miltefosine with GM-CSF do not improve therapeutic outcome.",2020,"The final cure rate at 180 days after the initiation of treatment was 44.4% in the Sb v group, 76.6% in the M+P group (P= 0.003 versus Sb v), and 75.6% in the M+GM group (P= 0.004 versus Sb v).","['133 patients with CL caused by L. braziliensis in Bahia, Brazil', 'cutaneous leishmaniasis caused by Leishmania braziliensis in Brazil']","['miltefosine and placebo (M+P', 'M+GM', 'Miltefosine', 'Miltefosine and topical GM-CSF', 'miltefosine combined with topical GM-CSF (M+GM', 'GM-CSF and miltefosine']","['final cure rate', 'healing time', 'Adverse events', 'cure rate', 'healing time of CL', 'By survival curve analysis median healing time for cure']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0331315', 'cui_str': 'Bahia'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0023271', 'cui_str': 'Leishmania viannia braziliensis'}]","[{'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",133.0,0.0564992,"The final cure rate at 180 days after the initiation of treatment was 44.4% in the Sb v group, 76.6% in the M+P group (P= 0.003 versus Sb v), and 75.6% in the M+GM group (P= 0.004 versus Sb v).","[{'ForeName': 'Paulo R L', 'Initials': 'PRL', 'LastName': 'Machado', 'Affiliation': 'Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Fernanda V O', 'Initials': 'FVO', 'LastName': 'Prates', 'Affiliation': 'Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Boaventura', 'Affiliation': 'Instituto Gonçalo Moniz (IGM), FIOCRUZ, Bahia, Brazil.'}, {'ForeName': 'Tainã', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Luiz H', 'Initials': 'LH', 'LastName': 'Guimarães', 'Affiliation': 'Universidade Federal do Sul da Bahia, Teixeira de Freitas, Brazil.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Schriefer', 'Affiliation': 'Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}, {'ForeName': 'Temis W F', 'Initials': 'TWF', 'LastName': 'Corte', 'Affiliation': 'Quatro G Pesquisa & Desenvolvimento, LTDA, Av. Ipiranga, Prédio 92A, Porto Alegre, Brasil.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Penna', 'Affiliation': 'Núcleo de Medicina Tropical, Universidade de Brasília (UnB), Brasília-DF, Brazil.'}, {'ForeName': 'Aldina', 'Initials': 'A', 'LastName': 'Barral', 'Affiliation': 'Instituto Gonçalo Moniz (IGM), FIOCRUZ, Bahia, Brazil.'}, {'ForeName': 'Manoel', 'Initials': 'M', 'LastName': 'Barral-Netto', 'Affiliation': 'Instituto Gonçalo Moniz (IGM), FIOCRUZ, Bahia, Brazil.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Carvalho', 'Affiliation': 'Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1337']
2012,32894382,Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial.,"We examined the efficacy of an early autism intervention for use in early childhood intervention (ECI) and mutual gaze as a contributor to social development. Seventy-eight families were randomly assigned to one of three 12-week interventions: Pathways (with a mutual gaze component), communication, or services-as-usual (SAU). The Pathways/SAU comparison concerned the efficacy of Pathways for ECI, and the Pathways/communication comparison, mutual gaze. The Pathways group made significantly more change on social measures, communicative synchrony, and adaptive functioning compared with the SAU group and on social measures compared with the communication group. There were no group differences for communicative acts. The results support Pathways as a potential ECI program and mutual gaze as an active ingredient for social and communication development.",2020,"The Pathways group made significantly more change on social measures, communicative synchrony, and adaptive functioning compared with the SAU group and on social measures compared with the communication group.","['Toddlers with ASD', 'Seventy-eight families']","['Pathways (with a mutual gaze component), communication, or services-as-usual (SAU', 'Mutual Gaze', 'early autism intervention']","['social measures, communicative synchrony, and adaptive functioning', 'communicative acts']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]",78.0,0.0148854,"The Pathways group made significantly more change on social measures, communicative synchrony, and adaptive functioning compared with the SAU group and on social measures compared with the communication group.","[{'ForeName': 'Pamela Rosenthal', 'Initials': 'PR', 'LastName': 'Rollins', 'Affiliation': 'Callier Center for Communication Disorders, University of Texas at Dallas, 1966 Inwood Road, Dallas, TX, 75235, USA. rollins@utdallas.edu.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'De Froy', 'Affiliation': 'Callier Center for Communication Disorders, University of Texas at Dallas, 1966 Inwood Road, Dallas, TX, 75235, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Pathways Early Autism Intervention, LLC, 255 Anglers Ridge, Bluff Dale, TX, USA.'}, {'ForeName': 'Renee Thibodeau', 'Initials': 'RT', 'LastName': 'Hoffman', 'Affiliation': 'Pathways Early Autism Intervention, LLC, 255 Anglers Ridge, Bluff Dale, TX, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04672-4']
2013,32882036,Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide.,"PURPOSE


The phase 3 CHIASMA OPTIMAL trial (NCT03252353) evaluated efficacy and safety of oral octreotide capsules (OOCs) in patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs).
METHODS


In this double-blind study, patients (N = 56) stratified by prior SRL dose were randomly assigned 1:1 to OOC or placebo for 36 weeks. The primary end point was maintenance of biochemical control at the end of treatment (mean insulin-like growth factor 1 [IGF-1] ≤ 1.0 × upper limit of normal [ULN]; weeks 34 and 36). Time to loss of IGF-1 response and proportion requiring reversion to injectable SRLs were assessed as broader control measures.
RESULTS


Mean IGF-1 measurements were 0.80 and 0.97 × ULN for OOC and 0.84 and 1.69 × ULN for placebo, at baseline and end of treatment, respectively. Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo. Normalization of IGF-1 levels (≤ 1.0 × ULN) was maintained in 58.2% for OOCs vs 19.4% for placebo (P = .008); GH levels were maintained (< 2.5 ng/mL) in 77.7% for OOC vs 30.4% for placebo (P = .0007). Median time to loss of response (IGF-1 > 1.0 or ≥ 1.3 × ULN definitions) for patients receiving placebo was 16 weeks; for patients receiving OOCs, it was not reached for both definitions during the 36-week trial (P < .0001). Of the patients in the OOC group, 75% completed the trial on oral therapy. The OOC safety profile was consistent with previous SRL experience.
CONCLUSIONS


OOCs may be an effective therapy for patients with acromegaly who previously were treated with injectable SRLs.",2020,Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo.,"['Patients Switching From Injectable Somatostatin Receptor Ligands to Oral', 'patients (N = 56) stratified by prior SRL dose', 'patients with acromegaly who previously demonstrated biochemical control while receiving injectable somatostatin receptor ligands (SRLs', 'patients with acromegaly who previously were treated with injectable SRLs']","['oral octreotide capsules (OOCs', 'Octreotide', 'placebo', 'OOC or placebo']","['Normalization of IGF-1 levels', 'GH levels', 'Median time to loss of response (IGF-1', 'Mean growth hormone (GH', 'Mean IGF-1 measurements', 'maintenance of biochemical control at the end of treatment (mean insulin-like growth factor 1 [IGF-1] ≤\u20051.0\u2005×\u2005upper limit of normal [ULN', 'OOC safety profile', 'Time to loss of IGF-1 response and proportion requiring reversion to injectable SRLs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001206', 'cui_str': 'Acromegaly'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028833', 'cui_str': 'Octreotide'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202056', 'cui_str': 'Growth hormone measurement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0074830', 'cui_str': 'Somatostatin Receptor'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]",,0.393388,Mean growth hormone (GH) changed from 0.66 to 0.60 ng/mL for OOCs and 0.90 to 2.57 ng/mL for placebo.,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Samson', 'Affiliation': ""Pituitary Center, Baylor St. Luke's Medical Center, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Nachtigall', 'Affiliation': 'Neuroendocrine Unit, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Pituitary Center, Oregon Health & Sciences University, Portland, Oregon, USA.'}, {'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Gordon', 'Affiliation': 'Allegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Bolanowski', 'Affiliation': 'Department of Endocrinology, Diabetes and Isotope Therapy, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Artak', 'Initials': 'A', 'LastName': 'Labadzhyan', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Ehud', 'Initials': 'E', 'LastName': 'Ur', 'Affiliation': 'University of British Columbia, Vancouver BC, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Molitch', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Ludlam', 'Affiliation': 'Chiasma Inc, Needham, Massachusetts, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Patou', 'Affiliation': 'Chiasma Inc, Needham, Massachusetts, USA.'}, {'ForeName': 'Asi', 'Initials': 'A', 'LastName': 'Haviv', 'Affiliation': 'Chiasma Inc, Needham, Massachusetts, USA.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Biermasz', 'Affiliation': 'Leiden University Medical Center, Oegstgeest, Netherlands.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giustina', 'Affiliation': 'Institute of Endocrine and Metabolic Sciences, San Raffaele Vita-Salute University, Milan, Italy.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Trainer', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Strasburger', 'Affiliation': 'Clinical Endocrinology, Charite-Universitätsmedizin, Campus Mitte, Berlin, Germany.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Kennedy', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Melmed', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa526']
2014,32882314,Treatment of giardiasis in children: Randomized trial of rectal metronidazole versus oral tinidazole.,"OBJECTIVES


We investigated the efficacy, safety and acceptance of rectally administered metronidazole for the treatment of giardiasis in children.
PATIENTS AND METHODS


This study (ClinicalTrials.gov Identifier: NCT02942485) was an open-labeled randomized comparison of a 3-day-course of rectal metronidazole and single-dose oral tinidazole in children with giardiasis. Clinical cure was defined as the resolution of symptoms by day 10 post-treatment. Microbiological eradication was assessed with stool enzyme immunoassay for G.duodenalis antigen on day 7-10 post-treatment.
RESULTS


The study was terminated due to the extremely slow enrollment. We describe the outcome for six patients treated with rectal metronidazole and one patient treated with oral tinidazole. All symptomatic patients (4/4) were clinically cured with rectal metronidazole. Microbiological eradication was successful after the first treatment course in all tested patients (6/6), of whom five were treated with rectal metronidazole and one with oral tinidazole. Side effects were reported in one patient and were restricted to a single episode of loose stool after the third dose of rectal metronidazole. The majority of caregivers (4/6) considered the administration of rectal metronidazole relatively easy.
CONCLUSIONS


We provide a proof of principle for the efficacy of rectally administered metronidazole in the treatment of giardiasis.",2020,Side effects were reported in one patient and were restricted to a single episode of loose stool after the third dose of rectal metronidazole.,"['children with giardiasis', 'giardiasis in children']","['metronidazole', 'tinidazole', 'rectal metronidazole', 'rectal metronidazole and single-dose oral tinidazole', 'oral tinidazole']","['Clinical cure', 'efficacy, safety and acceptance', 'Side effects', 'Microbiological eradication']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017536', 'cui_str': 'Giardiasis'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0040263', 'cui_str': 'Tinidazole'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}]",,0.072253,Side effects were reported in one patient and were restricted to a single episode of loose stool after the third dose of rectal metronidazole.,"[{'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Vakkilainen', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland. Electronic address: svetlana.vakkilainen@hus.fi.""}, {'ForeName': 'Tea', 'Initials': 'T', 'LastName': 'Nieminen', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Björkbacka', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Saavalainen-Hakala', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}, {'ForeName': 'Eeva', 'Initials': 'E', 'LastName': 'Salo', 'Affiliation': ""New Children's Hospital, Pediatric Research Center, University of Helsinki and HUS Helsinki University Hospital, Stenbäckinkatu 9, PL 347, 00290 Helsinki, Finland.""}]",The Journal of infection,['10.1016/j.jinf.2020.08.050']
2015,32883245,Interventions Made to Preserve Cognitive Function Trial (IMPCT) study protocol: a multi-dialysis center 2x2 factorial randomized controlled trial of intradialytic cognitive and exercise training to preserve cognitive function.,"BACKGROUND


Kidney disease and dialysis significantly impact cognitive function across the age spectrum. Cognitive training (CT) and/or exercise training (ET) are promising approaches to preserve cognitive function among community-dwelling older adults, but have not been tested for cognition preservation in hemodialysis patients of all ages. In this manuscript, we summarize the protocol for the Interventions Made to Preserve Cognitive Function Trial (IMPCT).
METHODS


We will perform a 2 × 2 factorial randomized controlled trial (RCT) of eligible adult (≥18 years) hemodialysis initiates (n = 200) to test whether intradialytic CT (brain games on a tablet PC), ET (foot peddlers) and combined CT + ET while undergoing hemodialysis preserves executive function compared to standard of care (SC). Participants will engage in the interventions to which they are randomized for 6 months. The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed. This primary outcome was selected based on findings from our pilot study. The secondary objectives are to compare the risk of secondary cognitive outcomes, ESKD-specific clinical outcomes, and patient-centered outcomes at 3-months and 6-months. All data collection and interventions are conducted in the dialysis center.
DISCUSSION


We hypothesize that receiving intradialytic CT or ET will better preserve executive function than SC but receiving combined CT + ET, will be the most effective intervention. The current trial will be an important step in understanding how intradialytic interventions might preserve cognitive health.
TRIAL REGISTRATION


Clinicaltrials.Gov (Date: 8/6/18): # NCT03616535 . Protocol Version: 10 (April 2020).
FUNDING


NIDDK R01DK114074.",2020,"The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed.","['hemodialysis patients of all ages', 'community-dwelling older adults', 'eligible adult (≥18\u2009years) hemodialysis initiates (n\u2009=\u2009200']","['intradialytic CT (brain games on a tablet PC), ET (foot peddlers) and combined CT\u2009+\u2009ET while undergoing hemodialysis preserves executive function compared to standard of care (SC', 'intradialytic cognitive and exercise training', 'Cognitive training (CT', 'and/or exercise training (ET']","['executive function', 'cognitive function', 'Trail Making Test A (TMTA) and B (TMTB); specifically, executive function', 'risk of secondary cognitive outcomes, ESKD-specific clinical outcomes, and patient-centered outcomes']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",,0.0909873,"The primary objective is to compare, among interventions, the 3-month change in executive function measured using the Trail Making Test A (TMTA) and B (TMTB); specifically, executive function is calculated as TMTB-TMTA to account for psychomotor speed.","[{'ForeName': 'Mara A', 'Initials': 'MA', 'LastName': 'McAdams-DeMarco', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA. mara@jhu.edu.'}, {'ForeName': 'Nadia M', 'Initials': 'NM', 'LastName': 'Chu', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Malu', 'Initials': 'M', 'LastName': 'Steckel', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Kunwar', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marlís', 'Initials': 'M', 'LastName': 'González Fernández', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Carlson', 'Affiliation': 'Department of Mental Health, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Fine', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615, N. Wolfe St, W6033, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Diener-West', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dorry L', 'Initials': 'DL', 'LastName': 'Segev', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",BMC nephrology,['10.1186/s12882-020-02041-y']
2016,32883279,Cost-effectiveness of a lifestyle intervention in high-risk individuals for diabetes in a low- and middle-income setting: Trial-based analysis of the Kerala Diabetes Prevention Program.,"BACKGROUND


Data on the cost-effectiveness of lifestyle-based diabetes prevention programs are mostly from high-income countries, which cannot be extrapolated to low- and middle-income countries. We performed a trial-based cost-effectiveness analysis of a lifestyle intervention targeted at preventing diabetes in India.
METHODS


The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial of 1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state. Participants (30-60 years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test. The intervention group received a 12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders. There were also linked community activities to sustain behavior change. The control group received a booklet on lifestyle change. Costs were estimated from the health system and societal perspectives, with 2018 as the reference year. Effectiveness was measured in terms of the number of diabetes cases prevented and quality-adjusted life years (QALYs). Three times India's gross domestic product per capita (US$6108) was used as the cost-effectiveness threshold. The analyses were conducted with a 2-year time horizon. Costs and effects were discounted at 3% per annum. One-way and multi-way sensitivity analyses were performed.
RESULTS


Baseline characteristics were similar in the two study groups. Over 2 years, the intervention resulted in an incremental health system cost of US$2.0 (intervention group: US$303.6; control group: US$301.6), incremental societal cost of US$6.2 (intervention group: US$367.8; control group: US$361.5), absolute risk reduction of 2.1%, and incremental QALYs of 0.04 per person. From a health system perspective, the cost per diabetes case prevented was US$95.2, and the cost per QALY gained was US$50.0. From a societal perspective, the corresponding figures were US$295.1 and US$155.0. For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively. The corresponding figures for QALY gained were 99.1% and 97.8%. The results were robust to discounting and sensitivity analyses.
CONCLUSIONS


A community-based peer-support lifestyle intervention was cost-effective in individuals at high risk of developing diabetes in India over 2 years.
TRIAL REGISTRATION


The trial was registered with Australia and New Zealand Clinical Trials Registry ( ACTRN12611000262909 ). Registered 10 March 2011.",2020,"For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively.","['1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state', 'Participants (30-60\u2009years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test', 'high-risk individuals for diabetes in a low- and middle-income setting']","['community-based peer-support lifestyle intervention', '12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders', 'lifestyle intervention', 'booklet on lifestyle change']","['Effectiveness', 'Costs and effects', 'Cost-effectiveness', 'incremental health system cost']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",1007.0,0.029418,"For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively.","[{'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. speaktosat@gmail.com.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kavumpurathu R', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Pilvikki', 'Initials': 'P', 'LastName': 'Absetz', 'Affiliation': 'Department of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Robyn J', 'Initials': 'RJ', 'LastName': 'Tapp', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Paul Z', 'Initials': 'PZ', 'LastName': 'Zimmet', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, UK.'}, {'ForeName': 'Sajitha', 'Initials': 'S', 'LastName': 'Balachandran', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Suman S', 'Initials': 'SS', 'LastName': 'Shetty', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aziz', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}]",BMC medicine,['10.1186/s12916-020-01704-9']
2017,32883309,"The effects of immediate programmed cryotherapy and continuous passive motion in patients after computer-assisted total knee arthroplasty: a prospective, randomized controlled trial.","BACKGROUND


The postoperative nursing intervention with immediate cryotherapy and continuous passive motion (CPM) remains elusive regarding the postoperative pain and range of motion (ROM) for patients undergoing computer-assisted total knee arthroplasty (CAS-TKA).
METHODS


A prospective, randomized controlled trial with a purposive sampling method was utilized. Sixty patients scheduled for a unilateral CAS-TKA at a medical center were randomly assigned to the intervention group (n = 30) and control group (n = 30). The intervention group applied programed cryotherapy and CPM within 1 h while returning to the ward on the day of surgery, while the control group did not. Data were analyzed using mixed models to compare the numeric rating scale (NRS) for pain, ROM, and swelling at postoperative day (POD) 4.
RESULTS


There was no significant difference in the NRS score between the groups (p = 0.168). The intervention group had significantly higher ROM than the control group (98° vs. 91°, p = 0.004) at POD 4. Although no significant difference in joint swelling was found between groups (p = 0.157), the intervention group had lower mean joint swelling (32.2 cm) than the control group (33.9 cm).
CONCLUSIONS


Immediate programmed cryotherapy and continuous passive motion could help to improve ROM quickly after CAS-TKA. It should be incorporated into the daily nursing plan for patients undergoing CAS-TKA.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04136431 . Registered 23 October 2019-retrospectively registered.",2020,"The intervention group had significantly higher ROM than the control group (98° vs. 91°, p = 0.004) at POD 4.","['patients undergoing CAS-TKA', 'Sixty patients scheduled for a unilateral CAS-TKA at a medical center', 'patients after computer-assisted total knee arthroplasty', 'patients undergoing computer-assisted total knee arthroplasty (CAS-TKA']","['programed cryotherapy and CPM', 'immediate cryotherapy and continuous passive motion (CPM', 'immediate programmed cryotherapy and continuous passive motion']","['joint swelling', 'ROM quickly', 'mean joint swelling', 'ROM', 'numeric rating scale (NRS) for pain, ROM, and swelling at postoperative day (POD) 4', 'NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0454405,"The intervention group had significantly higher ROM than the control group (98° vs. 91°, p = 0.004) at POD 4.","[{'ForeName': 'Mei-Chu', 'Initials': 'MC', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chiu-Chu', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jih-Yang', 'Initials': 'JY', 'LastName': 'Ko', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital, No. 123, Dapi Rd., Niaosong Dist., Kaohsiung, 833, Taiwan.'}, {'ForeName': 'Feng-Chih', 'Initials': 'FC', 'LastName': 'Kuo', 'Affiliation': 'Department of Orthopedic Surgery, Kaohsiung Chang Gung Memorial Hospital, No. 123, Dapi Rd., Niaosong Dist., Kaohsiung, 833, Taiwan. fongchikuo@cgmh.org.tw.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01924-y']
2018,32883322,"Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial.","BACKGROUND


Systemic glucocorticoids are effective for the management of chronic obstructive pulmonary disease (COPD) exacerbation but have serious adverse effects. Traditional Chinese medicine (TCM) can bring additional benefits to these patients but has few adverse effects. The present study aims to evaluate the efficacy and safety of Jia Wei Bushen Yiqi (JWBY) formulas in patients who suffer from COPD exacerbations and to investigate whether the short-term (5-days) systemic glucocorticoid therapy is non-inferior to the long-term (9-day) regime.
METHODS


In this multi-center, randomized, double-blinded trial, eligible inpatients with COPD exacerbation are randomly assigned to four groups (A, B, C, and D). Group A will receive placebo plus 5-day prednisone, group B will receive placebo plus 9-day prednisone, group C will receive JWBY formulas plus 5-day prednisone, and group D will receive JWBY formulas plus 9-day prednisone. The primary outcomes are the time interval to the patient's next exacerbation during a 180-day following up and the COPD assessment test (CAT) during treatment. Secondary outcomes include lung function, TCM syndrome assessment, laboratory tests, and safety. The changes of the hypothalamic pituitary adrenaline axis (HPA axis) and inflammatory cytokine will be measured as well.
DISCUSSION


By demonstrating the advantages of utilizing TCM and an appropriate duration of systemic glucocorticoids, this effectiveness comparison trial will provide new references to physicians on how to improve the management of COPD exacerbation. The results of HPA axis and inflammation cytokine measurements will shed light on the molecular mechanisms and entail further mechanism studies.
TRIAL REGISTRATION


www.chictr.org.cn ChiCTR1900023364. Registered on 24 May 2019.",2020,"Group A will receive placebo plus 5-day prednisone, group B will receive placebo plus 9-day prednisone, group C will receive JWBY formulas plus 5-day prednisone, and group D will receive JWBY formulas plus 9-day prednisone.","['eligible inpatients with COPD exacerbation', 'patients who suffer from COPD exacerbations and to investigate whether the short-term (5-days) systemic', 'acute exacerbation of COPD']","['glucocorticoids', 'Traditional Chinese medicine (TCM', 'glucocorticoid therapy', 'placebo plus 5-day prednisone', 'Jia Wei Bushen Yiqi formulas', 'placebo', 'placebo plus 9-day prednisone, group C will receive JWBY formulas plus 5-day prednisone, and group D will receive JWBY formulas plus 9-day prednisone', 'Jia Wei Bushen Yiqi (JWBY']","['lung function, TCM syndrome assessment, laboratory tests, and safety', ""time interval to the patient's next exacerbation during a 180-day following up and the COPD assessment test (CAT"", 'efficacy and safety', 'hypothalamic pituitary adrenaline axis (HPA axis) and inflammatory cytokine', 'Efficacy and safety']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0441838', 'cui_str': 'Group D'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.671731,"Group A will receive placebo plus 5-day prednisone, group B will receive placebo plus 9-day prednisone, group C will receive JWBY formulas plus 5-day prednisone, and group D will receive JWBY formulas plus 9-day prednisone.","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Kong', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shuming', 'Initials': 'S', 'LastName': 'Mo', 'Affiliation': 'Department of Integrative Medicine, North Hospital of Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Zihui', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yijie', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Baojun', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Lingwen', 'Initials': 'L', 'LastName': 'Kong', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yubao', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China. lvyubao80313@163.com.'}, {'ForeName': 'Jingcheng', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai, China. jingcheng_dong@yeah.net.'}]",Trials,['10.1186/s13063-020-04669-5']
2019,32883371,Non-steroidal or opioid analgesia use for children with musculoskeletal injuries (the No OUCH study): statistical analysis plan.,"BACKGROUND


Pediatric musculoskeletal injuries cause moderate to severe pain, which should ideally be addressed upon arrival to the emergency department (ED). Despite extensive research in ED-based pediatric pain treatment, recent studies confirm that pain management in this setting remains suboptimal. The No OUCH study consist of two complementary, randomized, placebo-controlled trials that will run simultaneously for patients presenting to the ED with an acute limb injury and a self-reported pain score of at least 5/10, measured via a verbal numerical rating scale (vNRS). Caregiver/parent choice will determine whether patients are randomized to the two-arm or three-arm trial. In the two-arm trial, patients will be randomized to receive either ibuprofen alone or ibuprofen in combination with acetaminophen. In the three-arm trial, patients can also be randomized to a third arm where they would receive ibuprofen in combination with hydromorphone. This article details the statistical analysis plan for the No OUCH study and was submitted before the trial outcomes were available for analysis.
METHODS/DESIGN


The primary endpoint of the No OUCH study is self-reported pain at 60 min, recorded using a vNRS. The principal safety outcome is the presence of any adverse event related to study drug administration. Secondary effectiveness endpoints include pain measurements using the Faces Pain Scale-Revised and the visual analog scale, time to effective analgesia, requirement of a rescue analgesic, missed fractures, and observed pain reduction using different definitions of successful analgesia. Secondary safety outcomes include sedation measured using the Ramsay Sedation Score and serious adverse events. Finally, the No OUCH study investigates the reasons given by the caregiver for selecting the two-arm (Non-Opioid) or three-arm (Opioid) trial, caregiver satisfaction, physician preferences for analgesics, and caregiver comfort with at-home pain management.
DISCUSSION


The No OUCH study will inform the relative effectiveness of acetaminophen and hydromorphone, in combination with ibuprofen, and ibuprofen alone as analgesic agents for patients presenting to the ED with an acute musculoskeletal injury. The data from these trials will be analyzed in accordance with this statistical analysis plan. This will reduce the risk of producing data-driven results and bias in our reported outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03767933 . Registered on December 7, 2018.",2020,"Secondary effectiveness endpoints include pain measurements using the Faces Pain Scale-Revised and the visual analog scale, time to effective analgesia, requirement of a rescue analgesic, missed fractures, and observed pain reduction using different definitions of successful analgesia.","['children with musculoskeletal injuries', 'patients presenting to the ED with an acute musculoskeletal injury']","['acetaminophen', 'acetaminophen and hydromorphone', 'ibuprofen alone or ibuprofen', 'hydromorphone', 'placebo', 'ibuprofen']","['sedation measured using the Ramsay Sedation Score and serious adverse events', 'self-reported pain at 60\u2009min, recorded using a vNRS', 'verbal numerical rating scale (vNRS', 'pain score', 'pain measurements using the Faces Pain Scale-Revised and the visual analog scale, time to effective analgesia, requirement of a rescue analgesic, missed fractures, and observed pain reduction using different definitions of successful analgesia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.225572,"Secondary effectiveness endpoints include pain measurements using the Faces Pain Scale-Revised and the visual analog scale, time to effective analgesia, requirement of a rescue analgesic, missed fractures, and observed pain reduction using different definitions of successful analgesia.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada. anna.heath@sickkids.ca.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hopkin', 'Affiliation': 'Institute of Health Economics, Edmonton, Alberta, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Institute of Health Economics, Edmonton, Alberta, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Pechlivanoglou', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Juan David', 'Initials': 'JD', 'LastName': 'Rios', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'Departments of Paediatrics, Internal Medicine, Epidemiology & Biostatistics, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04503-y']
2020,32884020,Health-related quality of life amongst people diagnosed with abdominal aortic aneurysm and peripheral artery disease and the effect of fenofibrate.,"The aims of this study were, firstly, to assess the effect of concurrent peripheral artery disease (PAD) on the health-related quality of life (QOL) of people diagnosed with a small abdominal aortic aneurysm (AAA); and secondly, to test whether the peroxisome proliferator-activated receptor α agonist fenofibrate improved QOL of people diagnosed with a small AAA, including those diagnosed with concurrent PAD. The study included both a cross-sectional observational study and a randomized placebo-controlled clinical trial. 140 people diagnosed with a 35-49 mm diameter AAA, 56 (40%) of whom had concurrent PAD, and 25 healthy controls were prospectively recruited. QOL was assessed with the short form (SF) 36. Findings in participants that were diagnosed with both AAA and PAD were compared separately with those of participants that had a diagnosis of AAA alone or who had neither AAA nor PAD diagnosed (healthy controls). All participants diagnosed with an AAA were then randomly allocated to 145 mg of fenofibrate per day or identical placebo. Outcomes were assessed by changes in the domains of the SF-36 and ankle brachial pressure Index (ABPI) from randomization to 24 weeks. Data were analyzed using Mann-Whitney U tests. Participants diagnosed with both AAA and PAD had significantly worse QOL than participants diagnosed with AAA alone or healthy controls. Fenofibrate did not significantly alter SF-36 scores or ABPI over 24 weeks. Fenofibrate does not improve QOL of people diagnosed with small AAA, irrespective of whether they have concurrent PAD.Trial registration: ACTN12613001039774 Australian New Zealand Clinical Trials Registry.",2020,Fenofibrate did not significantly alter SF-36 scores or ABPI over 24 weeks.,"['people diagnosed with abdominal aortic aneurysm and peripheral artery disease', 'All participants diagnosed with an AAA', 'participants that were diagnosed with both AAA and PAD were compared separately with those of participants that had a diagnosis of AAA alone or who had neither AAA nor PAD diagnosed (healthy controls', 'people diagnosed with a small abdominal aortic aneurysm (AAA', '140 people diagnosed with a 35-49\xa0mm diameter AAA, 56 (40%) of whom had concurrent PAD, and 25 healthy controls were prospectively recruited']","['fenofibrate per day or identical placebo', 'Fenofibrate', 'placebo', 'concurrent peripheral artery disease (PAD', 'fenofibrate']","['SF-36 and ankle brachial pressure Index (ABPI', 'Health-related quality of life', 'QOL', 'SF-36 scores or ABPI', 'health-related quality of life (QOL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0162871', 'cui_str': 'Abdominal aortic aneurysm'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1276055', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",140.0,0.588476,Fenofibrate did not significantly alter SF-36 scores or ABPI over 24 weeks.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Golledge', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Australian Institute of Tropical Medicine, James Cook University, Townsville, QLD, 4811, Australia. Jonathan.Golledge@jcu.edu.au.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Pinchbeck', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Australian Institute of Tropical Medicine, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Rowbotham', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Australian Institute of Tropical Medicine, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Lisan', 'Initials': 'L', 'LastName': 'Yip', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Australian Institute of Tropical Medicine, James Cook University, Townsville, QLD, 4811, Australia.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'Jenkins', 'Affiliation': ""Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Quigley', 'Affiliation': 'Mater Hospital, Townsville, QLD, Australia.'}, {'ForeName': 'Joseph V', 'Initials': 'JV', 'LastName': 'Moxon', 'Affiliation': 'Queensland Research Centre for Peripheral Vascular Disease, College of Medicine and Dentistry, Australian Institute of Tropical Medicine, James Cook University, Townsville, QLD, 4811, Australia.'}]",Scientific reports,['10.1038/s41598-020-71454-4']
2021,32884045,The effect on clinical outcomes when targeting spinal manipulation at stiffness or pain sensitivity: a randomized trial.,"The mechanisms underlying pain relief following spinal manipulative therapy (SMT) are not understood fully although biomechanical and neurophysiological processes have been proposed. As such, we designed this randomized trial to elucidate the contributions of biomechanical and neurophysiological processes. A total of 132 participants with low back pain were randomly assigned to receive SMT at either the lumbar segment measured as the stiffest or the segment measured as having the lowest pain threshold. The primary outcome was patient reported low back pain intensity following treatment. Secondary outcomes were biomechanical stiffness and neurophysiological pressure pain threshold. All outcomes were measured at baseline, after the fourth and final session and at 2-weeks follow-up. Data were analyzed using linear mixed models, and demonstrated that the SMT application site did not influence patient reported low back pain intensity or stiffness. However, a large and significant difference in pressure pain threshold was observed between groups. This study provides support that SMT impacts neurophysiological parameters through a segment-dependent neurological reflex pathway, although this do not seem to be a proxy for improvement. This study was limited by the assumption that the applied treatment was sufficient to impact the primary outcome.",2020,"Data were analyzed using linear mixed models, and demonstrated that the SMT application site did not influence patient reported low back pain intensity or stiffness.",['132 participants with low back pain'],"['SMT', 'spinal manipulative therapy (SMT']","['low back pain intensity', 'pressure pain threshold', 'biomechanical stiffness and neurophysiological pressure pain threshold', 'low back pain intensity or stiffness']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0949742', 'cui_str': 'Therapy, Manipulation'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",132.0,0.172307,"Data were analyzed using linear mixed models, and demonstrated that the SMT application site did not influence patient reported low back pain intensity or stiffness.","[{'ForeName': 'Casper Glissmann', 'Initials': 'CG', 'LastName': 'Nim', 'Affiliation': 'Medical Research Unit, Spine Centre of Southern Denmark, University Hospital of Southern Denmark, Odense, Denmark. casper.nim@rsyd.dk.'}, {'ForeName': 'Gregory Neil', 'Initials': 'GN', 'LastName': 'Kawchuk', 'Affiliation': 'Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Schiøttz-Christensen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': ""O'Neill"", 'Affiliation': 'Medical Research Unit, Spine Centre of Southern Denmark, University Hospital of Southern Denmark, Odense, Denmark.'}]",Scientific reports,['10.1038/s41598-020-71557-y']
2022,32886121,The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging: A Stepped-Wedge Randomized Clinical Trial.,"Importance


Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions.
Objective


To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions.
Design, Setting, and Participants


This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019.
Interventions


Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group).
Main Outcomes and Measures


Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality.
Results


We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, -0.7%; 95% CI, -2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, -29.3%; 95% CI, -42.1% to -13.5%; magnetic resonance imaging: difference, -3.4%; 95% CI, -8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04).
Conclusions and Relevance


In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented.
Trial Registration


ClinicalTrials.gov Identifier: NCT02015455.",2020,"We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04).
","['Adults Undergoing Spine Imaging', '250\u202f401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States', 'November 2018 to October 2019', 'Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year', 'individuals without back pain (intervention group', 'A total of 117\u202f455 patients (49.2%) were randomized to the control group, and 121\u202f431 patients (50.8', 'We enrolled 250\u202f401 participants (of whom 238\u202f886 [95.4%] met eligibility for this analysis, with 137\u202f373 [57.5%] women and 105\u202f497 [44.2%] aged >60 years) from 3278 primary care clinicians']",['standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data'],"['Health Care Utilization', 'cumulative spine-related RVUs', 'likelihood of opioid prescribing', 'adjusted median (interquartile range) RVU', 'Measures\n\n\nHealth care utilization', 'Rates of subsequent RVUs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C4274373', 'cui_str': 'Imaging report'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205345', 'cui_str': 'Relative'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",250401.0,0.27778,"We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04).
","[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Jarvik', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Meier', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'James', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Gold', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Kessler', 'Affiliation': 'Department of Health Services, University of Washington, Seattle.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Suri', 'Affiliation': 'Rehabilitation Care Services, VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Kallmes', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Cherkin', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Deyo', 'Affiliation': 'Departments of Family Medicine and Internal Medicine, Oregon Health and Science University, Portland.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington, Seattle.'}, {'ForeName': 'Safwan S', 'Initials': 'SS', 'LastName': 'Halabi', 'Affiliation': 'Department of Radiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Patrick H', 'Initials': 'PH', 'LastName': 'Luetmer', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Avins', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Rundell', 'Affiliation': 'Comparative Effectiveness, Cost, and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Griffith', 'Affiliation': 'Department of Radiology, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Janna L', 'Initials': 'JL', 'LastName': 'Friedly', 'Affiliation': 'Comparative Effectiveness, Cost, and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Danielle C', 'Initials': 'DC', 'LastName': 'Lavallee', 'Affiliation': 'Surgical Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Turner', 'Affiliation': 'Comparative Effectiveness, Cost, and Outcomes Research Center, University of Washington, Seattle.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Bresnahan', 'Affiliation': 'Department of Radiology, University of Washington, Seattle.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15713']
2023,32887379,"Effects of Capsinoid Intake on Brown Adipose Tissue Vascular Density and Resting Energy Expenditure in Healthy, Middle-Aged Adults: A Randomized, Double-Blind, Placebo-Controlled Study.","Capsinoids are some of the most promising ingredients to increase energy expenditure (EE) due to brown adipose tissue (BAT) activation. However, there is limited information regarding the effect of prolonged capsinoid ingestion (CI) on BAT activity and resting EE (REE) in healthy, middle-aged, normal to overweight subjects (Sub healthy ) with distinct BAT characteristics. We examined the changes in BAT density (BAT-d), using near-infrared time-resolved spectroscopy, and REE/kg induced by daily CI. Forty Sub healthy  [age, 43.8 (mean) years; BMI, 25.4 kg/m 2 ] received either capsinoid (9 mg/day) or a placebo daily for 6 weeks in a double-blind design. Total hemoglobin concentration in the supraclavicular region ([total-Hb] sup ), an indicator of BAT-d, and REE/kg were measured. The changes in post-intervention [total-Hb] sup  were greater in the capsinoid group (CA-G) than in the placebo group (PL-G) [5.8 µM (+12.4%) versus 1.0 µM (+2.1%);  p  = 0.017]. There was a significant relationship between BAT-d and REE/kg; however, post-supplementation REE/kg was not significantly different between the two groups ( p  = 0.228). In the overweight subgroup, changes in REE/kg were greater in the CA-G than in the PL-G [0.6 cal/kg/min (+4.3%) versus -0.3 cal/kg/min (-2.1%);  p  = 0.021]. CI enhanced [total-Hb] sup , a reflection of BAT-d, showing a good correlation with REE in Sub healthy .",2020,"In the overweight subgroup, changes in REE/kg were greater in the CA-G than in the PL-G [0.6 cal/kg/min (+4.3%) versus -0.3 cal/kg/min (-2.1%);  p  = 0.021].","['Forty Sub healthy  [age, 43.8 (mean) years', 'healthy, middle-aged, normal to overweight subjects (Sub healthy ) with distinct BAT characteristics', 'Healthy, Middle-Aged Adults']","['prolonged capsinoid ingestion (CI', 'Capsinoid Intake', 'placebo', 'capsinoid', 'Placebo']","['energy expenditure (EE', 'BAT activity and resting EE (REE', 'Total hemoglobin concentration', 'CI enhanced [total-Hb', 'Brown Adipose Tissue Vascular Density and Resting Energy Expenditure']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",,0.334693,"In the overweight subgroup, changes in REE/kg were greater in the CA-G than in the PL-G [0.6 cal/kg/min (+4.3%) versus -0.3 cal/kg/min (-2.1%);  p  = 0.021].","[{'ForeName': 'Sayuri', 'Initials': 'S', 'LastName': 'Fuse', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Tasuki', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Riki', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Kuroiwa', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ando', 'Affiliation': 'Department of Sport Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo 115-0056, Japan.'}, {'ForeName': 'Ayami', 'Initials': 'A', 'LastName': 'Kume', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Ajinomoto Co., Inc., Institute of Food Sciences and Technologies, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Kanna', 'Initials': 'K', 'LastName': 'Kuribayashi', 'Affiliation': 'Ajinomoto Co., Inc., Institute of Food Sciences and Technologies, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Somekawa', 'Affiliation': 'Ajinomoto Co., Inc., Institute of Food Sciences and Technologies, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Masamichi', 'Initials': 'M', 'LastName': 'Takeshita', 'Affiliation': 'Ajinomoto Co., Inc., Research Institute for Bioscience Products & Fine Chemicals, 1-1 Suzuki-cho, Kawasaki-ku, Kawasaki City, Kanagawa 210-8681, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Hashimoto', 'Affiliation': 'Ajinomoto Co., Inc., Direct Marketing Department, 15-1, Kyobashi 1-chome, Chuo-ku, Tokyo 104-8315, Japan.'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Kime', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Kurosawa', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hamaoka', 'Affiliation': 'Department of Sports Medicine for Health Promotion, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan.'}]",Nutrients,['10.3390/nu12092676']
2024,32887411,Effect of a Combined Program of Strength and Dual Cognitive-Motor Tasks in Multiple Sclerosis Subjects.,"This study investigated the effects of a 24-week combined training program (CTP) based on strength exercises and cognitive-motor tasks performed concurrently in participants with multiple sclerosis. A randomized, controlled intervention study was carried out. In total, 31 subjects with a confirmed diagnosis of multiple sclerosis (14 men and 17 women) were stratified and randomized into an intervention group (17 subjects) and a control group (14 subjects). The intervention group completed three weekly training sessions for 24 weeks, while the control group pursued their normal daily activities. In this program, cognitive-motor tasks were completed at once (dual tasking). A 3D photogrammetry connected to a selective attention system designed for dual tasking while walking was used. Ground reaction forces were measured using two force plates, one for sit-to-stand testing, while the other was used for static force measurement. Postural equilibrium was examined using a stabilometric plate based for Romberg test assessment. The 24-week training program for multiple sclerosis patients improved their static peak force by 11% ( p  < 0 .05), their rate of force development by 36% ( p  < 0.05), and their balance ( p  < 0.05). Performance in daily activities such as walking or sitting-to-standing improved significantly in multiple sclerosis participants. CTP training was effective in reducing the dual-task costs of step length (48%) and walking velocity (54%), as compared to a matched control group.",2020,"The 24-week training program for multiple sclerosis patients improved their static peak force by 11% ( p  < 0 .05), their rate of force development by 36% ( p  < 0.05), and their balance ( p  < 0.05).","['multiple sclerosis participants', '31 subjects with a confirmed diagnosis of multiple sclerosis (14 men and 17 women', 'Multiple Sclerosis Subjects', 'participants with multiple sclerosis']","['Combined Program of Strength and Dual Cognitive-Motor Tasks', 'combined training program (CTP', 'CTP training']","['Performance in daily activities such as walking or sitting-to-standing', 'static peak force', 'dual-task costs of step length', 'walking velocity', 'rate of force development']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",31.0,0.0141606,"The 24-week training program for multiple sclerosis patients improved their static peak force by 11% ( p  < 0 .05), their rate of force development by 36% ( p  < 0.05), and their balance ( p  < 0.05).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gutiérrez-Cruz', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Rojas-Ruiz', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'De la Cruz-Márquez', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Gutiérrez-Dávila', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, 18071 Granada, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176397']
2025,32887521,Using Social Network Sites to Boost Savoring: Positive Effects on Positive Emotions.,"Research has demonstrated that positive interventions (PIs) can be effective in enhancing well-being. Our study used Facebook to conduct a PI based on savoring. Sixty-one university students in Taiwan were randomly assigned to undergo a three-week savoring PI, and 61 participants were assigned to a no-treatment control group. The results showed significantly enhanced positive affect in the treatment group compared to the control group, in both a post-test and a final follow-up, but no significant differences between the two groups in negative affect. The treatment group also displayed significantly lower depression in the post-test, which was not maintained at the follow-up. These results indicate that, for university students, a savoring intervention via Facebook can be an effective way of enhancing positive emotions.",2020,"The results showed significantly enhanced positive affect in the treatment group compared to the control group, in both a post-test and a final follow-up, but no significant differences between the two groups in negative affect.","['university students', 'Sixty-one university students in Taiwan']",[],"['lower depression', 'Positive Emotions']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",61.0,0.0165675,"The results showed significantly enhanced positive affect in the treatment group compared to the control group, in both a post-test and a final follow-up, but no significant differences between the two groups in negative affect.","[{'ForeName': 'Sen-Chi', 'Initials': 'SC', 'LastName': 'Yu', 'Affiliation': 'Department of Counseling and Applied Psychology, National Taichung University of Education, West District, Taichung City 403, Taiwan.'}, {'ForeName': 'Kennon M', 'Initials': 'KM', 'LastName': 'Sheldon', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Wen-Ping', 'Initials': 'WP', 'LastName': 'Lan', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO 65211, USA.'}, {'ForeName': 'Jia-Huei', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Sciences, University of Missouri, Columbia, MO 65211, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176407']
2026,32887548,Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study.,"BACKGROUND


The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire.
METHODS


In the extension study (N = 1842), adults with migraine were randomized to quarterly or monthly fremanezumab. After completing active treatment, patients answered a survey evaluating patient satisfaction, treatment and dosing preferences, and changes in patient-reported outcomes.
RESULTS


Of the 557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey. The mean (standard deviation) satisfaction rating for fremanezumab was 6.1 (1.4; 1 = ""extremely dissatisfied"" to 7 = ""extremely satisfied""). Most patients (175 [69.2%]) preferred quarterly over monthly fremanezumab dosing. Among patients taking antiepileptics (most common class of prior preventive medication; n = 130), 91.5% preferred fremanezumab. Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab.
CONCLUSION


In this study, treatment satisfaction with fremanezumab was high, most patients preferred quarterly fremanezumab dosing, and fremanezumab was generally preferred to prior preventive medications.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02638103 (HALO LTS), registered December 22, 2015.",2020,"Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab.
","['patients taking antiepileptics (most common class of prior preventive medication; n\u2009=\u2009130), 91.5% preferred', 'adults with migraine', '557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey']",['fremanezumab'],"['mean (standard deviation) satisfaction rating for fremanezumab', 'quality of time spent', 'anxiety', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0519529,"Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab.
","[{'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, 10461, USA. dbuse@montefiore.org.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ramirez-Campos', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Blaine', 'Initials': 'B', 'LastName': 'Cloud', 'Affiliation': 'Clinical SCORE, Chadds Ford, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Cowan', 'Affiliation': 'Stanford University, Stanford, CA, USA.'}]",The journal of headache and pain,['10.1186/s10194-020-01177-4']
2027,32887557,"Maternal oxygen exposure may not change umbilical cord venous partial pressure of oxygen: non-random, paired venous and arterial samples from a randomised controlled trial.","BACKGROUND


Despite the widespread use of oxygen (O 2 ) in intrauterine resuscitation, the obstetric scientists' understanding of O 2  therapy is full of contradictions. We tested the hypothesis that higher maternal arterial partial pressure of oxygen (PO 2 ) is associated with higher umbilical cord venous PO 2  (UvPO 2 ).
METHODS


This is a planned secondary analysis of a randomised controlled trial (RCT), 443 normal women were 1:1 randomly allocated to receive 2 L/min O 2  or room air from the onset of second stage to delivery. We reported that maternal 2 L/min O 2  exposure cannot affect the umbilical cord arterial pH or the fetal heart rate (FHR) pattern. In 217 non-random samples, we found 2 L/min O 2  exposure increased the maternal arterial PO 2  to the median 150 mmHg (hemoglobin would be saturated). The primary outcome for this analysis was UvPO 2  in these non-random samples.
RESULTS


There were no significant differences between the O 2  group (N = 107) and the control group (N = 110) in the UvPO 2  (median 30.2, interquartile 25.4-35.2 versus median 28.3, interquartile 23.4-35.3, mmHg, P = 0.379). There were also no significant differences between room air and different percentiles of O 2  exposure duration (< 25th, ≧ 25th < 50th, ≧ 50th < 75th, ≧ 75th percentile) in the UvPO 2 .
CONCLUSIONS


Maternal O 2  exposure at super-physiological levels (median arterial blood PO 2  150 mmHg) in normal labor may not change the UvPO 2 .
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT02221440 , first posted in 20 August 2014.",2020,"There were no significant differences between the O 2  group (N = 107) and the control group (N = 110) in the UvPO 2  (median 30.2, interquartile 25.4-35.2 versus median 28.3, interquartile 23.4-35.3, mmHg, P = 0.379).",['443 normal women'],['Maternal oxygen exposure'],"['maternal arterial partial pressure of oxygen', 'umbilical cord arterial pH or the fetal heart rate (FHR) pattern', 'UvPO 2  in these non-random samples']","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",443.0,0.429057,"There were no significant differences between the O 2  group (N = 107) and the control group (N = 110) in the UvPO 2  (median 30.2, interquartile 25.4-35.2 versus median 28.3, interquartile 23.4-35.3, mmHg, P = 0.379).","[{'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Chuai', 'Affiliation': 'Chinese PLA General Hospital, Medical School of Chinese PLA, Fuxing Road No. 28, Beijing, 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anaesthesia, Chaoyang Chinese Traditional and Western Medicine Emergency Medical Center, Beijing, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynaecology, Sixth Medical Center, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Chinese PLA General Hospital, Medical School of Chinese PLA, Fuxing Road No. 28, Beijing, 100853, China. wangyh85@foxmail.com.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Chinese PLA General Hospital, Medical School of Chinese PLA, Fuxing Road No. 28, Beijing, 100853, China. 3313400243@qq.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03212-3']
2028,32891516,"A 3-year prospective study on the metabolic effect of aripiprazole, quetiapine and ziprasidone: A pragmatic clinical trial in first episode psychosis patients.","Schizophrenia is a severe brain disorder with an excess morbidity and mortality partly due to a higher incidence of metabolic disturbances and cardio-vascular events. The exposure to antipsychotic treatment has been observed linked to these metabolic abnormalities. This study explores the metabolic effects of aripiprazol, quetiapine and ziprasidone in drug-naïve patients with a first-episode of psychosis, at long-term. Two-hundred and two patients with first-episode of psychosis were included in the study. Patients were randomly assigned to receive quetiapine, ziprasidone, or aripiprazole. Clinical, sociodemographic and anthropometric measures, as well as lipid and glyceamic parameters, were recorded at baseline and after three years of initiating antipsychotic treatment. Body weight and BMI increased significantly after 3 years of follow-up (F = 35.0, p<0.001; and F = 37.6, p<0.001, respectively). Most of the increase in weight occurred within the first year of treatment. The proportion of patients meeting criteria for obesity (5.6% vs 25.7%; p<0.001), hypercholesterolemia (23.2% vs 41.7%; p<0.001) and hypertriglyceridemia (5.8% vs 23.0%; p<0.001) increased significantly. Head-to-head comparisons between antipsychotic groups revealed that the ziprasidone group presented significantly smaller increments in weight (p = 0.034) and BMI (p = 0.020) than aripiprazole group. After 3 years of having presented a first episode of psychosis, patients show significant increments in body weight and BMI, as well as in lipid and glycaemic parameters leading to clinical metabolic disturbances. In this context, the first year is the critical period for weight gain and development of metabolic changes. In this study, ziprasidone produced smaller weight gain than aripiprazole.",2020,"The proportion of patients meeting criteria for obesity (5.6% vs 25.7%; p<0.001), hypercholesterolemia (23.2% vs 41.7%; p<0.001) and hypertriglyceridemia (5.8% vs 23.0%; p<0.001) increased significantly.","['Two-hundred and two patients with first-episode of psychosis were included in the study', 'drug-naïve patients with a first-episode of psychosis, at long-term', 'first episode psychosis patients']","['aripiprazol, quetiapine and ziprasidone', 'quetiapine, ziprasidone, or aripiprazole', 'aripiprazole', 'ziprasidone', 'aripiprazole, quetiapine and ziprasidone']","['BMI', 'Body weight and BMI', 'weight', 'hypertriglyceridemia', 'body weight and BMI', 'smaller weight gain', 'proportion of patients meeting criteria for obesity', 'hypercholesterolemia']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]",202.0,0.01343,"The proportion of patients meeting criteria for obesity (5.6% vs 25.7%; p<0.001), hypercholesterolemia (23.2% vs 41.7%; p<0.001) and hypertriglyceridemia (5.8% vs 23.0%; p<0.001) increased significantly.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Vázquez-Bourgon', 'Affiliation': 'Department of Psychiatry, University Hospital Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda.Valdecilla s/n, Santander 39008, Spain; Centro de Investigación Biomédica en Red en Salud Mental (CIBERSAM), Spain; Department of Medicine and Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. Electronic address: javier.vazquez@scsalud.es.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ibáñez Alario', 'Affiliation': 'Department of Psychiatry, University Hospital Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda.Valdecilla s/n, Santander 39008, Spain.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Mayoral-van Son', 'Affiliation': 'Centro de Investigación Biomédica en Red en Salud Mental (CIBERSAM), Spain; Department of Psychiatry, School of Medicine, University Hospital Virgen del Rocio-IBiS, Sevilla, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Gómez Revuelta', 'Affiliation': 'Department of Psychiatry, University Hospital Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda.Valdecilla s/n, Santander 39008, Spain; Department of Medicine and Psychiatry, School of Medicine, University of Cantabria, Santander, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Ayesa Arriola', 'Affiliation': 'Department of Psychiatry, University Hospital Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda.Valdecilla s/n, Santander 39008, Spain; Centro de Investigación Biomédica en Red en Salud Mental (CIBERSAM), Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Juncal Ruiz', 'Affiliation': 'Department of Medicine and Psychiatry, School of Medicine, University of Cantabria, Santander, Spain; Department of Psychiatry, Sierrallana Hospital, IDIVAL, Torrelavega, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Ortiz-García de la Foz', 'Affiliation': 'Department of Psychiatry, University Hospital Marqués de Valdecilla, Instituto de Investigación Marqués de Valdecilla (IDIVAL), Avda.Valdecilla s/n, Santander 39008, Spain.'}, {'ForeName': 'Benedicto', 'Initials': 'B', 'LastName': 'Crespo Facorro', 'Affiliation': 'Centro de Investigación Biomédica en Red en Salud Mental (CIBERSAM), Spain; Department of Psychiatry, School of Medicine, University Hospital Virgen del Rocio-IBiS, Sevilla, Spain.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.08.009']
2029,32891521,Ultrasound-Guided Out-of-Plane Versus In-Plane Radial Artery Cannulation in Adult Cardiac Surgical Patients.,"OBJECTIVES


The primary objective was to compare the rate of first-pass radial arterial cannulation using out-of-plane ultrasound guidance with in-plane imaging. The secondary endpoints were a comparison of the number of times the cannula was redirected, the number of attempts, the number of skin punctures, the incidence of hematoma, the time to completion of the cannulation procedure, and the number of failed attempts between the 2 ultrasound imaging techniques.
DESIGN


A prospective, randomized, observational study.
SETTING


A tertiary cardiac care center.
PARTICIPANTS


Adult patients undergoing elective cardiac surgery.
INTERVENTIONS


Radial artery cannulation with ultrasound guidance.
MEASUREMENTS AND MAIN RESULTS


Eighty-four adult patients scheduled for elective cardiac surgery were randomly assigned to the out-of-plane ultrasound group (group I, n = 42) or the in-plane ultrasound group (group II, n = 42) for left radial artery cannulation. A linear ultrasound probe was used to identify the radial artery. In each approach, the number of times first-pass success was achieved, the number of times the cannula was redirected, the number of skin punctures, the incidence of hematomas, and the number of failed attempts were recorded. The first-pass success rate was greater in the in-plane ultrasound group and was statistically significant (p = 0.007). In the out-of-plane ultrasound group, a larger number of patients needed redirection of the cannula (p = 0.002). The number of patients in whom the skin needed to be punctured more than once was greater in the out-of-plane ultrasound group compared with the in-plane ultrasound group (p = 0.002). The incidence of hematoma formation and time to completion of the technique were similar in both groups (p = 0.241 and p = 0.792, respectively).
CONCLUSIONS


In-plane ultrasound guidance appeared to be superior for achieving a higher first-pass success rate more often with minimal redirections and skin punctures compared with out-of-plane ultrasound guidance.",2020,"The incidence of hematoma formation and time to completion of the technique were similar in both groups (p = 0.241 and p = 0.792, respectively).
","['Adult patients undergoing elective cardiac surgery', 'A tertiary cardiac care center', 'Eighty-four adult patients scheduled for elective cardiac surgery', 'Adult Cardiac Surgical Patients']","['pass radial arterial cannulation using out-of-plane ultrasound guidance with in-plane imaging', 'left radial artery cannulation', 'Radial artery cannulation with ultrasound guidance', 'Plane Radial Artery Cannulation', 'Ultrasound-Guided Out-of-Plane']","['number of times first-pass success', 'number of times the cannula was redirected, the number of attempts, the number of skin punctures, the incidence of hematoma, the time to completion of the cannulation procedure, and the number of failed attempts between the 2 ultrasound imaging techniques', 'number of skin punctures, the incidence of hematomas', 'incidence of hematoma formation and time to completion of the technique', 'first-pass success rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0449809', 'cui_str': 'Number of times'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",84.0,0.0435453,"The incidence of hematoma formation and time to completion of the technique were similar in both groups (p = 0.241 and p = 0.792, respectively).
","[{'ForeName': 'Nishant Ram', 'Initials': 'NR', 'LastName': 'Arora', 'Affiliation': 'Department of Cardiac Anesthesia, National Heart Center, Royal Hospital, Muscat, Oman.'}, {'ForeName': 'Madan Mohan', 'Initials': 'MM', 'LastName': 'Maddali', 'Affiliation': 'Department of Cardiac Anesthesia, National Heart Center, Royal Hospital, Muscat, Oman. Electronic address: madanmaddali@hotmail.com.'}, {'ForeName': 'Rashid Ahmed Rashid', 'Initials': 'RAR', 'LastName': 'Al-Sheheimi', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Hajer', 'Initials': 'H', 'LastName': 'Al-Mughairi', 'Affiliation': 'Oman Medical Specialty Board, Muscat, Oman.'}, {'ForeName': 'Sathiya Murthi', 'Initials': 'SM', 'LastName': 'Panchatcharam', 'Affiliation': 'Department of Studies and Research, Oman Medical Specialty Board, Muscat, Oman.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.08.025']
2030,32891527,Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes.,"BACKGROUND AND PURPOSE


To investigate the effects of adding virtual activity groups to a multicomponent ambulatory activity monitoring intervention in managing chronic conditions such as obesity and type 2 diabetes.
METHODS


We randomized 120 subjects with type 2 diabetes to receive an activity monitor with or without placement into virtual activity groups. We monitored subjects over six months and collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data.
RESULTS


All subjects lost significant weight over the course of the study (p = 0.005); however, there was no statistically significant difference in mean weight loss between two groups (p = 0.520). HbA1c decreased in both groups, but was not statistically significant (p = 0.084). Daily step counts were similar between groups (p = 0.633), but both groups did decrease significantly over time (p = 0.004). There was no linear correlation between daily step count and HbA1c (p = 0.609), but there was between daily step count and weight (p = 0.016) although this only accounted for 5.6% of weight loss. There were no significant differences found for blood pressure and Rand SF36 measures between groups or times, or group-time interactions with two exceptions. The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001). Compliance remained high, with 93.8% of subjects actively participating at the conclusion of the study.
CONCLUSIONS


Activity monitoring with in-person goal-setting and scripted feedback over six months was associated with significant weight loss with or without virtual support groups.",2020,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,['120 subjects with type 2 diabetes to receive an'],"['multicomponent ambulatory activity monitoring intervention', 'activity monitor with or without placement into virtual activity groups']","['weight loss', 'Daily step counts', 'collected HbA1c, weight, step count, blood pressure, and SF-36 questionnaire data', 'mean weight loss', 'blood pressure and Rand SF36 measures', 'SF36 Health Change measure', 'HbA1c']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",120.0,0.0201026,The SF36 Role functioning/emotional measure showed an interaction between group and time (p = 0.039) and the SF36 Health Change measure had a significant difference due to time irrespective of group (p < 0.0001).,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lystrup', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carlsen', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Sharon', 'Affiliation': 'San Antonio, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crawford', 'Affiliation': '99th MDG, Nellis Air Force Base, NV, 89191, USA. Electronic address: drpaulcrawford@aol.com.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.08.006']
2031,32891604,Multifactorial intervention has a significant effect on diabetic kidney disease in patients with type 2 diabetes.,"To evaluate the effect of multifactorial intervention on the onset and progression of diabetic kidney disease in the patients with type 2 diabetes, we analyzed the effects of intensified multifactorial intervention (intensive therapy treatment targets; HbA1c under 6.2%, blood pressure under 120/75 mmHg, low-density lipoprotein cholesterol under 80 mg/dL) comparing with step-wise intensification of medications and life-style modifications of guideline-based standard care (conventional therapy treatment targets: HbA1c under 6.9%, blood pressure under 130/80 mmHg, low-density lipoprotein cholesterol under 120 mg/dL) on diabetic kidney disease. A total of 2540 eligible patients in the Japan Diabetes Optimal 101 Integrated Treatment for three major risk factors of coronary diseases cohort (J- DOIT3) were randomly assigned to intensive therapy (1269) and conventional therapy (1271) and treated for a median of 8.5 years. The prespecified kidney outcome measure was a composite of progression from normoalbuminuria to microalbuminuria or progression from normoalbuminuria to macroalbuminuria or progression from microalbuminuria to macroalbuminuria, serum creatinine levels elevated by two-fold or more compared to baseline, or kidney failure. Primary analysis was carried out on the intention-to-treat population. Changes in the estimated glomerular filtration rate and albuminuria were also analyzed. A total of 438 kidney events occurred (181 in the intensive therapy group and 257 in the conventional therapy group). Intensive therapy was associated with a significant 32% reduction in kidney events compared to conventional therapy and was associated with a change in HbA1c at one year from study initiation. Thus, prespecified analysis shows that intensified multifactorial intervention significantly reduced the onset and progression of diabetic kidney disease compared to currently recommended care.",2020,Intensive therapy was associated with a significant 32% reduction in kidney events compared to conventional therapy and was associated with a change in HbA1c at one year from study initiation.,"['patients with type 2 diabetes', '2540 eligible patients in the Japan Diabetes Optimal 101 Integrated Treatment for three major risk factors of coronary diseases cohort (J- DOIT3']","['Multifactorial intervention', 'intensive therapy (1269) and conventional therapy', 'intensified multifactorial intervention (intensive therapy treatment targets; HbA1c under 6.2%, blood pressure under 120/75 mmHg, low-density lipoprotein cholesterol under 80 mg/dL) comparing with step-wise intensification of medications and life-style modifications of guideline-based standard care (conventional therapy treatment targets: HbA1c under 6.9%, blood pressure under 130/80 mmHg, low-density lipoprotein cholesterol under 120 mg/dL', 'multifactorial intervention']","['438 kidney events', 'glomerular filtration rate and albuminuria', 'onset and progression of diabetic kidney disease', 'kidney events', 'diabetic kidney disease', 'composite of progression from normoalbuminuria to microalbuminuria or progression from normoalbuminuria to macroalbuminuria or progression from microalbuminuria to macroalbuminuria, serum creatinine levels elevated by two-fold or more compared to baseline, or kidney failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}]",2540.0,0.0280344,Intensive therapy was associated with a significant 32% reduction in kidney events compared to conventional therapy and was associated with a change in HbA1c at one year from study initiation.,"[{'ForeName': 'Kohjiro', 'Initials': 'K', 'LastName': 'Ueki', 'Affiliation': 'Department of Molecular Diabetic Medicine, Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Sasako', 'Affiliation': 'Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Okazaki', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Miyake', 'Affiliation': 'Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Nangaku', 'Affiliation': 'Department of Nephrology and Endocrinology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Diabetes, Metabolism and Endocrinology, Ichikawa Hospital, International University of Health and Welfare, Chiba, Japan; Department of Endocrinology and Diabetes, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Japan; Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Toranomon Hospital, Tokyo, Japan. Electronic address: kadowaki-3im@h.u-tokyo.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Kidney international,['10.1016/j.kint.2020.08.012']
2032,32891738,Efficacy and safety of micafungin in empiric and D-index-guided early antifungal therapy for febrile neutropenia; A subgroup analysis of the CEDMIC trial.,"OBJECTIVES


The D-index is defined as the area over the neutrophil curve during neutropenia. The CEDMIC trial confirmed the noninferiority of D-index-guided early antifungal therapy (DET) using micafungin to empirical antifungal therapy (EAT). In this study, we evaluated the efficacy and safety of micafungin in these settings.
METHODS


From the CEDMIC trial, we extracted 67 and 113 patients who received micafungin in the DET and EAT groups, respectively. Treatment success was defined as the fulfillment of all components of a five-part composite end point. Fever resolution was evaluated at seven days after the completion of therapy.
RESULTS


The proportion of high-risk treatments including induction chemotherapy for acute leukemia and allogeneic hematopoietic stem cell transplantation was significantly higher in the DET group than in the EAT group (82.1% vs. 52.2%). The efficacy of micafungin was 68.7% (95%CI: 56.2-79.4) and 79.6% (71.0-86.6) in the DET and EAT groups, respectively. When we focused on high-risk treatments, the efficacy was 69.1% (55.2-80.9%) and 78.0% (65.3-87.7%), respectively (P = 0.30). There was no significant difference in any of the 5 components between the two groups.
CONCLUSIONS


The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.",2020,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"['febrile neutropenia', 'patients undergoing high-risk treatment', '113 patients who received micafungin in the DET and EAT groups, respectively', 'From the CEDMIC trial']",['micafungin'],"['efficacy and safety', 'Efficacy and safety', 'Fever resolution', 'acute leukemia and allogeneic hematopoietic stem cell transplantation']","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1120386', 'cui_str': 'micafungin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1120386', 'cui_str': 'micafungin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",,0.054726,The efficacy of micafungin in patients undergoing high-risk treatment was not strongly impaired in DET compared to that in EAT.,"[{'ForeName': 'Shun-Ichi', 'Initials': 'SI', 'LastName': 'Kimura', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Kanda', 'Affiliation': 'Division of Hematology, Jichi Medical University Saitama Medical Center; Division of Hematology, Department of Medicine, Jichi Medical University. Electronic address: ycanda-tky@umin.ac.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Iino', 'Affiliation': 'Department of Medical Oncology, Yamanashi Prefectural Central Hospital.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Sakaida', 'Affiliation': 'Department of Hematology, Chiba University Hospital.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Oyake', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Hematology, Nippon Medical School.'}, {'ForeName': 'Shin-Ichiro', 'Initials': 'SI', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Hematology, Department of Medicine, Jichi Medical University.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Jo', 'Affiliation': 'Department of Oncology and Hematology / Infection Control Division, Shimane University Hospital.'}, {'ForeName': 'Akinao', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Department of Hematology, Fujita Health University School of Medicine.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Department of Hematology, Saiseikai Yokohama Nanbu Hospital.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takamatsu', 'Affiliation': 'Division of Medical Oncology, Hematology and Infectious Diseases, Department of Internal Medicine, Fukuoka University Hospital.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Saburi', 'Affiliation': 'Department of Hematology, Oita Prefectural Hospital.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Matsumura', 'Affiliation': 'Department of Hematology and Rheumatology, Kindai University Faculty of Medicine.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yamanouchi', 'Affiliation': 'Departments of Hematology, Clinical Immunology and Infectious Diseases, Ehime University Graduate School of Medicine.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Shiratori', 'Affiliation': 'Department of Hematology, Hokkaido University, Faculty of Medicine.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Hematology, Tokyo Medical University.'}, {'ForeName': 'Shingen', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Community Medicine and Medical Science, Tokushima University Graduate School of Biomedical Sciences.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'General Medical Research Center, Fukuoka University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.08.081']
2033,32891794,Evaluation of a 3D-Printed-Head Simulation Technique for Teaching Flexible Nasopharyngoscopy to Radiation Oncology Residents.,"PURPOSE


Simulation-based medical education (SBME) is an effective tool for medical teaching, but SBME deployment in radiation oncology (RO) is limited. Flexible nasopharyngoscopy (FNP), an essential skill for RO residents, requires practice that typically occurs on volunteer patients, introducing the potential for stress and discomfort. We sought to develop a high-fidelity simulator and intervention that provides RO residents the opportunity to develop FNP skills in a low-pressure environment.
METHODS


CT images were utilized to create an anatomically-accurate 3D-printed model of the head and neck region. An intervention incorporating didactic instruction, multimedia content, and FNP practice on the model was designed and administered to RO residents attending the Anatomy and Radiology Contouring Bootcamp. Participants completed pre- and post-intervention evaluations of the training session and model fidelity, and self-assessments of FNP skill and confidence performing FNP. Participants were video-recorded performing FNP pre- and post-intervention. Videos were scored by a blinded observer on a pre-defined rubric. Changes in scores were evaluated using the Wilcoxon signed rank test.
RESULTS


Twenty-four participants from 17 institutions and 4 countries completed the intervention, 50% were female, and most were senior residents. Post-intervention, FNP confidence and FNP performance improved significantly (mean ± SD on a 10-point scale: 1.8 ± 1.8, p < 0.001; 2.2 ± 2.0, p < 0.001 respectively). Participants felt the model was helpful (mean ± SD on a 5-point scale: 4.2 ± 0.6), anatomically correct (4.1 ± 0.9), and aided in spatial comprehension (4.3 ± 0.8). Overall satisfaction intervention was high (4.3 ± 0.8). Participants strongly agreed the intervention should be integrated into RO training programs (4.3 ± 0.8).
CONCLUSIONS


A 3D-printed model and associated intervention were effective at improving FNP performance and the teaching method was rated highly by participants. RO residents may benefit from broader dissemination of this technique to improve trainee performance.",2020,"Post-intervention, FNP confidence and FNP performance improved significantly (mean ± SD on a 10-point scale: 1.8 ± 1.8, p < 0.001; 2.2 ± 2.0, p < 0.001 respectively).","['Teaching Flexible Nasopharyngoscopy to Radiation Oncology Residents', 'Twenty-four participants from 17 institutions and 4 countries completed the intervention, 50% were female, and most were senior residents']","['Simulation-based medical education (SBME', 'Flexible nasopharyngoscopy (FNP']","['FNP confidence and FNP performance', 'Overall satisfaction intervention', 'FNP performance']","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013631', 'cui_str': 'Medical Education'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0189025', 'cui_str': 'Nasopharyngoscopy'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",50.0,0.0308012,"Post-intervention, FNP confidence and FNP performance improved significantly (mean ± SD on a 10-point scale: 1.8 ± 1.8, p < 0.001; 2.2 ± 2.0, p < 0.001 respectively).","[{'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Goodman', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Pautler', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Balestrini', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Cobos', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Radiation Oncology, Rush University Medical Centre, Chicago, Illinois, USA.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Eansor', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jasbir', 'Initials': 'J', 'LastName': 'Jaswal', 'Affiliation': 'Department of Radiation Oncology, BC Cancer, Surrey, British Columbia, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Norris', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Manas', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiology, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Willmore', 'Affiliation': 'Department of Anatomy and Cell Biology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada. Electronic address: Andrew.Warner@lhsc.on.ca.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Murrell', 'Affiliation': 'Department of Physics and Engineering, London Regional Cancer Program, London, Ontario, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Department of Radiation Oncology, London Health Sciences Centre, London, Ontario, Canada. Electronic address: David.Palma@lhsc.on.ca.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.08.063']
2034,32891871,No tDCS Augmented Working Memory Training Benefit in Undergraduates Rewarded with Course Credit.,"BACKGROUND


The goal of working memory (WM) training is to expand capacity of this executive function. Transcranial direct current stimulation (tDCS) paired with WM training is more consistent than either alone. We have reported that tDCS targeting frontal and/or parietal regions enhanced theta phase locking, reduced alpha power, and strengthened theta-gamma phase amplitude coupling.
OBJECTIVE


To determine whether tDCS to frontal or parietal sites optimized WM training gains we pre-registered a tDCS-WM training study.
METHODS


80 undergraduates were randomly assigned to one of four anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4). Participants completed 5-training sessions over one week and returned for follow-up testing after 30 days of no-contact.
RESULTS


No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
CONCLUSIONS


This null finding marks a failure to replicate in undergraduates training benefits observed in graduate students. We argue that motivation is essential to elicit improved performance in training protocols.",2020,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","['graduate students', '80 undergraduates']","['anodal tDCS montages: frontal (F4), parietal (P4), alternating (P4-F4), and sham (P4 or F4', 'Transcranial direct current stimulation (tDCS) paired with WM training', 'working memory (WM) training']",['trained or transfer task performance'],"[{'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",80.0,0.033538,"No group showed significant improvement in trained or transfer task performance at the end of training nor at follow-up.
","[{'ForeName': 'Jorja', 'Initials': 'J', 'LastName': 'Shires', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences and Program in Integrative Neuroscience, Department of Psychology, Reno, NV 89557.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Carrasco', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences and Program in Integrative Neuroscience, Department of Psychology, Reno, NV 89557; University of California, Davis, Program in Neuroscience, Davis, CA 95616.'}, {'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Berryhill', 'Affiliation': 'University of Nevada, Program in Cognitive and Brain Sciences and Program in Integrative Neuroscience, Department of Psychology, Reno, NV 89557. Electronic address: mberryhill@unr.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.08.015']
2035,32891892,A multicenter effectiveness trial of QEEG-informed neurofeedback in ADHD: Replication and treatment prediction.,"INTRODUCTION


Quantitative Electroencephalogram-(QEEG-)informed neurofeedback is a method in which standard neurofeedback protocols are assigned, based on individual EEG characteristics in order to enhance effectiveness. Thus far clinical effectiveness data have only been published in a small sample of 21 ADHD patients. Therefore, this manuscript aims to replicate this effectiveness in a new sample of 114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset and to investigate potential predictors of neurofeedback response.
METHODS


A sample of 114 patients were included as a replication sample. Patients were treated with standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice. The ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI) were assessed at baseline, every 10th session, and at outtake. Holland Sleep Disorder Questionnaire (HSDQ) was assessed at baseline and outtake. Response was defined as ≥25% reduction (R25), ≥50% reduction (R50), and remission. Predictive analyses were focused on predicting remission status.
RESULTS


In the current sample, response rates were 85% (R25), 70% (R50), and remission was 55% and clinical effectiveness was not significantly different from the original 2012 sample. Non-remitters exhibited significantly higher baseline hyperactivity ratings. Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
DISCUSSION


In the current sample, clinical effectiveness was replicated, suggesting it is possible to assign patients to a protocol based on their individual baseline QEEG to enhance signal-to-noise ratio. Furthermore, remitters had lower baseline hyperactivity scores. Likewise, female remitters had shorter P300 latencies, whereas boys who remitted have a lower iAPF. Our data suggests initial specificity in treatment allocation, yet further studies are needed to replicate the predictors of neurofeedback remission.",2020,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","['21 ADHD patients', 'A sample of 114 patients were included as a replication sample', '114 patients treated with QEEG-informed neurofeedback, from a large multicentric dataset']","['standard neurofeedback protocols (Sensori-Motor-Rhythm (SMR), Theta-Beta (TBR), or Slow Cortical Potential (SCP) neurofeedback), in combination with coaching and sleep hygiene advice', 'QEEG']","['Holland Sleep Disorder Questionnaire (HSDQ', 'response rates', 'ADHD Rating Scale (ADHD-RS) and Pittsburgh Sleep Quality Index (PSQI', 'baseline hyperactivity scores', 'shorter P300 latencies', 'clinical effectiveness', 'baseline hyperactivity ratings']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444781', 'cui_str': 'P300 (P3)'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}]",114.0,0.0593453,"Women who remitted had significantly shorter P300 latencies and boys who remitted had significantly lower iAPF's.
","[{'ForeName': 'Noralie', 'Initials': 'N', 'LastName': 'Krepel', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Egtberts', 'Affiliation': 'neuroCare Group Netherlands, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Sack', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Heinrich', 'Affiliation': 'Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; neuroCare Group, Munich, Germany; kbo-Heckscher-Klinikum, Munich, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'neuroCare Group, Sydney, Australia.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Dept. of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands; Research Institute Brainclinics, Brainclinics Foundation, Nijmegen, The Netherlands; Dept. of Experimental Psychology, Utrecht University, Utrecht, The Netherlands. Electronic address: martijn@brainclinics.com.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102399']
2036,32891918,Working memory moderates the relation between the brain-derived neurotropic factor (BDNF) and psychotherapy outcome for depression.,"BACKGROUND


Insight into patient characteristics that predict response to treatment for major depressive disorder (MDD) may help to personalize treatment and improve outcomes. One mechanism that has been linked to the success of treatment for MDD is brain-derived neurotropic factor (BDNF). BDNF is implicated in learning and memory and may play a role in the effects of psychotherapy that involves changing cognitions and behaviors. In addition, only in individuals with low BDNF, low working memory capacity has been associated with increased symptoms of depression. However, the role of BDNF and working memory capacity in psychotherapy outcome is unclear. The aim of this study was to investigate the role of BDNF and its interaction with working memory capacity in psychotherapy outcomes for MDD.
METHOD


Adult patients with MDD were randomized to weekly or twice weekly sessions of cognitive behavioral therapy or interpersonal psychotherapy. BDNF Val66Met polymorphism (rs6265) (n = 138) was defined and serum BDNF was quantified before (n = 138) and after psychotherapy (n = 82).
RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions. Working memory capacity significantly moderated the relation between baseline serum BDNF and outcome: high serum BDNF at baseline was related to less depressive symptoms following psychotherapy in the presence of high working memory capacity, but not low working memory capacity.
DISCUSSION


These findings, if replicated, might indicate that while BDNF may not be related to psychotherapy outcomes in general, they may play a role in the presence of specific learning processes such as working memory capacity.",2020,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","['Adult patients with MDD', 'major depressive disorder (MDD']","['cognitive behavioral therapy or interpersonal psychotherapy', 'BDNF', 'brain-derived neurotropic factor (BDNF) and psychotherapy']","['serum BDNF', 'depressive symptoms', 'Baseline serum BDNF and the Val66Met polymorphism']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]",138.0,0.0539135,"RESULTS


Baseline serum BDNF and the Val66Met polymorphism were not associated with outcome and associations did not differ between treatment conditions.","[{'ForeName': 'Sanne J E', 'Initials': 'SJE', 'LastName': 'Bruijniks', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Clinical Psychology and Psychotherapy, University of Freiburg, Freiburg, Germany. Electronic address: sanne.bruijniks@psychologie.uni-freiburg.de.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'de Kluiver', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Christiaan H', 'Initials': 'CH', 'LastName': 'Vinkers', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; Department of Anatomy and Neurosciences, Amsterdam University Medical Center, Amsterdam Neuroscience, Amsterdam, the Netherlands.'}, {'ForeName': 'Frenk', 'Initials': 'F', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam University Medical Center, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Vrije Universiteit Amsterdam; GGZ InGeest Specialized Mental Health Care, Amsterdam, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Neurochemistry Lab, Department of Clinical Chemistry, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam Neuroscience, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, Philadelphia, United States.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.045']
2037,32892184,A single bout of coordination training does not lead to EIH in young healthy men - a RCT.,"Objectives Physical activity can lead to hypoalgesic effects and is often recommended as part of multidisciplinary pain management. Based on the idea, that in future specific and more differentiated sports therapeutic interventions could be used for a multidisciplinary pain management, various type of sports and their effects on pain sensitivity should be analysed. Whereas endurance as well as strengthening exercises are associated with a decrease in pain sensitivity in healthy people as well as people with chronic pain states, the effects of a specific coordination training (CT) on pain sensitivity have not yet been sufficiently investigated. Therefore, aim of the present study was to examine if a single bout of CT leads to exercised-induced hypoalgesia in young healthy men. Methods Thirty five healthy men (mean age 27 ± 3 years) were examined in a randomised crossover design before and after a single bout of 45-min CT and a 45-min resting session as control condition by means of Quantitative Sensory Testing (QST). The QST is a validated instrument to assess the function of the somatosensory system, by applying thermal and mechanical stimuli. By doing so, various detection and pain thresholds were determined at the dorsum of one foot. Exercises of CT were chosen to generate high proprioceptive input for the ankle joints. Results Analysis of the QST data in respect of the factors group (CT/control condition), time (pre/post) and stimuli (parameter of QST) revealed no statistically significant main effects of a single bout of CT on somatosensory system, neither for the factors group*time (p=0.51), nor the factors group*time*stimuli (p=0.32). All stimuli remained constant in the course of both conditions (e.g. mean ± sd of heat pain threshold pre/post in °C: coordination: 44.7 ± 3.1/44.8 ± 2.9; rest: 45.5 ± 3.0/44.9 ± 3.0). Conclusions In this setting, a single bout of CT had no effect on the somatosensory system in young healthy men. Therefore, this specific CT did not lead to an exercised-induced hypoalgesia in healthy people. Intensity of sensory input during training intervention might be too low to generate analgesic effects in a non-pathological altered somatosensory system of young healthy men. Further research is needed to clarify if a CT can induce exercised-induced hypoalgesia in people with pathological alterations of the somatosensory system. In addition, it has to examined if analgesic effects can be induced by changing the intensity of CT in healthy people. Detailed knowledge regarding the effects of different training interventions on pain modulation is needed to completely understand the mechanism of exercised-induced hypoalgesia.",2020,Intensity of sensory input during training intervention might be too low to generate analgesic effects in a non-pathological altered somatosensory system of young healthy men.,"['healthy people', 'young healthy men\xa0- a RCT', 'Methods Thirty five healthy men (mean age 27\xa0±\xa03 years', 'young healthy men']","['specific coordination training (CT', 'QST', '45-min CT and a 45-min resting session as control condition by means of Quantitative Sensory Testing (QST', 'coordination training', 'CT']",['pain sensitivity'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0419112', 'cui_str': 'Coordination training'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",35.0,0.0257008,Intensity of sensory input during training intervention might be too low to generate analgesic effects in a non-pathological altered somatosensory system of young healthy men.,"[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Herzig', 'Affiliation': 'Department of Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Krüger', 'Affiliation': 'Department of Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hilberg', 'Affiliation': 'Department of Sports Medicine, University of Wuppertal, Wuppertal, Germany.'}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0036']
2038,32892222,"A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects.","BACKGROUND


Clostridioides difficile infection is the most common cause of healthcare-associated infections in the USA, with limited treatment options. Ibezapolstat is a novel DNA polymerase IIIC inhibitor with in vitro activity against C. difficile.
OBJECTIVES AND METHODS


Randomized, double-blind, placebo-controlled study to assess the safety, tolerability and pharmacokinetics of ibezapolstat in healthy volunteers. Microbiome changes associated with ibezapolstat were compared with vancomycin over a 10 day course using shotgun metagenomics.
RESULTS


A total of 62 subjects aged 31 ± 7 years (45% female; average BMI: 25 ± 3 kg/m2) were randomized. Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period. In the multiday, multiple-dose arm, baseline microbiota was comparable between subjects that received ibezapolstat compared with vancomycin. At Day 10 of dosing, differential abundance analysis and β-diversity demonstrated a distinct difference between the microbiome in subjects given vancomycin compared with either dose of ibezapolstat (P = 0.006). α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
CONCLUSIONS


Ibezapolstat was shown to be safe and well tolerated, with minimal systemic exposure, high stool concentrations and a distinct microbiome profile compared with oral vancomycin. These results support further clinical development of ibezapolstat for patients with C. difficile infection.",2020,"α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
","['62 subjects aged 31\u2009±\u20097\u2009years (45% female; average BMI: 25\u2009±\u20093\u2009kg/m2', 'patients with C. difficile infection', 'healthy volunteers', 'healthy subjects']","['placebo', 'Ibezapolstat', 'vancomycin', 'ibezapolstat']","['minimal systemic absorption', 'safety, tolerability and pharmacokinetics', 'α-Diversity changes', 'safe and well tolerated', 'safety, pharmacokinetics and food and faecal microbiome effects']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C3850076', 'cui_str': 'Absorption, Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",62.0,0.388054,"α-Diversity changes were characterized as an increase in the Actinobacteria phylum in subjects that received ibezapolstat and an increase in Proteobacteria in subjects given vancomycin.
","[{'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Garey', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Khurshida', 'Initials': 'K', 'LastName': 'Begum', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lancaster', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Gonzales-Luna', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Dinh', 'Initials': 'D', 'LastName': 'Bui', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mercier', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Seng Yue', 'Affiliation': 'Learn and Confirm Inc., Montreal, Canada.'}, {'ForeName': 'Murray P', 'Initials': 'MP', 'LastName': 'Ducharme', 'Affiliation': 'Learn and Confirm Inc., Montreal, Canada.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Silverman', 'Affiliation': 'Acurx Pharmaceuticals LLC, White Plains, NY, USA.'}, {'ForeName': 'M Jahangir', 'Initials': 'MJ', 'LastName': 'Alam', 'Affiliation': 'University of Houston, Houston, TX, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Altasciences Clinical Kansas, Overland Park, KS, USA.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa364']
2039,32892235,Application of Latent Class Analysis to Identify Subgroups of Children with Autism Spectrum Disorders who Benefit from Social Skills Training.,"With Latent Class Analysis applied on data of 98 children with autism spectrum disorder (ASD) (9-12 years; 17 girls) participating in social skills training (SST) in a randomized controlled trial (Dekker et al. 2019), four subgroups were detected, based on social-communicative skills before, and response patterns to training. Two subgroups improved after SST. Characterizing the subgroups based on participant and intervention characteristics showed that improvement was related to lower parent-reported perceived difficulty of social-communicative skills at start, higher verbal ability, younger age and milder symptoms of ASD and anxiety. The lowest performing non-improving subgroup participated more often in SST without parent/teacher involvement, compared to all other subgroups. Response to SST in ASD seems to vary depending on participant characteristics.",2020,"The lowest performing non-improving subgroup participated more often in SST without parent/teacher involvement, compared to all other subgroups.","['Spectrum Disorders who Benefit from Social Skills Training', 'Children with Autism', '98 children with autism spectrum disorder (ASD) (9-12\xa0years; 17 girls) participating in']",['social skills training (SST'],"['difficulty of social-communicative skills at start, higher verbal ability, younger age and milder symptoms of ASD and anxiety']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0150777', 'cui_str': 'Social skills training'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",98.0,0.0217513,"The lowest performing non-improving subgroup participated more often in SST without parent/teacher involvement, compared to all other subgroups.","[{'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Dekker', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Maaike H', 'Initials': 'MH', 'LastName': 'Nauta', 'Affiliation': 'Accare, University Center for Child and Adolescent Psychiatry, PO Box 660, 9700 AR, Groningen, The Netherlands.'}, {'ForeName': 'Marieke E', 'Initials': 'ME', 'LastName': 'Timmerman', 'Affiliation': 'Department of Psychometrics and Statistics, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Mulder', 'Affiliation': 'Center for Intellectual Disabilities and Psychiatry, GGZ Drenthe, Assen, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'de Bildt', 'Affiliation': 'Department of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. a.de.bildt@accare.nl.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04678-y']
2040,32892250,Effect of ketogenic diet versus regular diet on voice quality of patients with Parkinson's disease.,Diets that have effects on health problems can vary in their composition. Whilst following a regular diet (RD) a person typically consumes about 30% of calories from fat. Ketogenic diet (KD) is a form of diet whereby a person consumes as much as 90% of calories from fat. KD has been trialed as a treatment for neurological diseases and obesity. Parkinson's disease (PD) is a neurologic disease that impacts the quality of voice. Voice Handicap Index (VHI) is a test that gives information to clinical and physiological assessment about voice. We assessed the impact of KD and RD on voice quality (VQ). Seventy-four patients with PD who reported a voice disorder related to their disease were randomly assigned to the KD or RD groups. We investigated the VHI change of subjects before and 3 months after diet. Sixty-eight PD patients completed the study. Baseline VHI values did not differ significantly between groups. All mean VHI parameters improved in KD group (p˂ 0.001). Currently there are different therapies that address speech and voice disorders in patients with PD. As such KD may be an alternative therapy to improve VQ of patients with PD. A larger sample size is necessary to determine the role and pathophysiology of KD on VQ of PD patients.,2020,All mean VHI parameters improved in KD group (p˂ 0.001).,"[""Parkinson's disease (PD"", 'patients with PD', 'Sixty-eight PD patients completed the study', ""patients with Parkinson's disease"", 'Seventy-four patients with PD who reported a voice disorder related to their disease']","['ketogenic diet versus regular diet', 'Ketogenic diet (KD', 'KD']","['mean VHI parameters', 'voice quality (VQ', 'voice quality', 'Voice Handicap Index (VHI', 'Baseline VHI values']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042940', 'cui_str': 'Voice Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",74.0,0.0166714,All mean VHI parameters improved in KD group (p˂ 0.001).,"[{'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Koyuncu', 'Affiliation': 'Department of Otorhinolaryngology, Eskisehir Gov Hosp, Cavdarlar Street, Eskisehir, 26080, Turkey.'}, {'ForeName': 'Vural', 'Initials': 'V', 'LastName': 'Fidan', 'Affiliation': 'Department of Otorhinolaryngology, Eskisehir Gov Hosp, Cavdarlar Street, Eskisehir, 26080, Turkey. vuralf@mynet.com.'}, {'ForeName': 'Hayal', 'Initials': 'H', 'LastName': 'Toktas', 'Affiliation': 'Department of Neurology, Atasehir Memorial Hospital, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Binay', 'Affiliation': 'Department of Otorhinolaryngology, Corlu State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Celik', 'Affiliation': 'Department of Neurology, Buhara Hospital, Erzurum, Turkey.'}]",Acta neurologica Belgica,['10.1007/s13760-020-01486-0']
2041,32884576,Skills to Enhance Positivity in Suicidal Adolescents: Results from a Pilot Randomized Clinical Trial.,"The objective of this study was to examine the feasibility, acceptability, and preliminary effects of an intervention, Skills to Enhance Positivity (STEP) that aims to increase attention to positive emotions and experiences and to decrease suicidal events. STEP involves four in-person individual sessions delivered during an inpatient psychiatric admission, followed by one month of weekly phone calls and daily text messages with mood monitoring and skills practice. A pilot randomized controlled trial of STEP vs. enhanced treatment as usual (ETAU) was conducted with 52 adolescents. Results indicated that on average 83% of sessions were completed and that on 70% of days, participants engaged with the text-messaging component of the intervention. Acceptability for both in-person and text-messaging components were also high, with satisfaction ratings averaging between good and excellent. STEP participants reported fewer suicide events than ETAU participants (6 vs. 13) after six months of follow-up.",2020,STEP participants reported fewer suicide events than ETAU participants (6 vs. 13) after six months of follow-up.,"['Suicidal Adolescents', '52 adolescents']",['STEP'],"['suicide events', 'suicidal events']","[{'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}]",,0.207429,STEP participants reported fewer suicide events than ETAU participants (6 vs. 13) after six months of follow-up.,"[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert School of Medicine, Brown University, Providence, USA.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ranney', 'Affiliation': 'Injury Prevention Center, Rhode Island Hospital, Providence, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Krek', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert School of Medicine, Brown University, Providence, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Peters', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert School of Medicine, Brown University, Providence, USA.'}, {'ForeName': 'Ethan H', 'Initials': 'EH', 'LastName': 'Mereish', 'Affiliation': 'Department of Health Studies, American University, Washington DC, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Tezanos', 'Affiliation': 'Teachers College, Columbia University, New York, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Solomon', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Beard', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert School of Medicine, Brown University, Providence, USA.'}]",The journal of positive psychology,['10.1080/17439760.2019.1615105']
2042,32885909,Toddler obesity prevention: A two-generation randomized attention-controlled trial.,"Rapid weight gain increases risks of obesity and associated co-morbidities. The objective was to reduce the rate of body mass index (BMI) growth (BMI z score), relative to control. Secondary outcomes were toddler-mother physical activity, mealtime interactions and fruit/vegetable intake. The randomized three-arm, eight-session, 4-month trial, conducted 2009-2013, included two intervention arms (responsive parenting and maternal lifestyle) and an attention control (home safety). Baseline and 6- and 12-month follow-up evaluations included weight and length/height, ankle accelerometry, video-recorded mealtime interactions (Emotional Availability Scales) and 24-h diet recalls (Healthy Eating Index-2015 [HEI-2015]). Analyses used linear mixed-effects models with repeated measures comparing intervention versus control changes in BMI z score. We recruited 277 racially mixed (70% African American) toddler-mother dyads (mean ages 20.1 months and 27.3 years) from US WIC and primary care clinics and randomized them into intervention versus control; 31% toddlers and 73% mothers were overweight/obese. At follow-up, changes in the rate of toddler BMI z score and maternal BMI were non-significant. Maternal lifestyle group toddlers and mothers spent 24.43 and 11.01 more minutes in physical activity (95% confidence interval [CI]: 2.55, 46.32, and 95% CI: 1.48, 20.54, respectively). Fruit intake increased in both intervention groups. Hostile mealtime interactions increased in the maternal lifestyle group, and in supplementary analyses, mealtime interactions were significantly higher in the responsive parenting group than in the maternal lifestyles group, suggesting that toddler dietary interventions include responsive parenting. Intervention effects were stronger among older versus younger toddlers. Despite no impact on weight gain, additional research should examine integrated two-generation responsive parenting and maternal lifestyle interventions among toddler-mother dyads.",2020,"At follow-up, changes in the rate of toddler BMI z score and maternal BMI were non-significant.",['277 racially mixed (70% African American) toddler-mother dyads (mean ages 20.1 months and 27.3 years) from US WIC and primary care clinics and randomized them into intervention versus control; 31% toddlers and 73% mothers were overweight/obese'],['intervention arms (responsive parenting and maternal lifestyle) and an attention control (home safety'],"['weight and length/height, ankle accelerometry, video-recorded mealtime interactions (Emotional Availability Scales) and 24-h diet recalls (Healthy Eating Index-2015 [HEI-2015', 'rate of toddler BMI z score and maternal BMI', 'weight gain', 'physical activity', 'Hostile mealtime interactions', 'rate of body mass index (BMI) growth (BMI z score', 'Toddler obesity prevention', 'toddler-mother physical activity, mealtime interactions and fruit/vegetable intake', 'Fruit intake', 'BMI z score']","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}]",,0.0455246,"At follow-up, changes in the rate of toddler BMI z score and maternal BMI were non-significant.","[{'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics and Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics and Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics and Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Hurley', 'Affiliation': 'Center for Human Nutrition, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'Latta', 'Affiliation': 'Institute for Innovation and Implementation, University of Maryland School of Social Work, Baltimore, Maryland, USA.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Candelaria', 'Affiliation': 'Institute for Innovation and Implementation, University of Maryland School of Social Work, Baltimore, Maryland, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Caulfield', 'Affiliation': 'Center for Human Nutrition, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}]",Maternal & child nutrition,['10.1111/mcn.13075']
2043,32886070,The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation.,"BACKGROUND


Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence.
OBJECTIVE


This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence.
METHODS


Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants' use and acceptability of the intervention.
RESULTS


A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy.
CONCLUSIONS


Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.",2020,The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days.,"['Participants were recruited from ambulatory clinics and randomized to a', 'A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women', 'individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring']","['30-day intervention or usual care', 'smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring']","['daily activity', 'acceptability and adherence', 'HRQoL and adherence', 'AFEQT and adherence', 'self-reported adherence to anticoagulation therapy', 'total AFEQT scores', 'Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",120.0,0.139244,The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days.,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Guhl', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Pusateri', 'Affiliation': 'School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Everlyne', 'Initials': 'E', 'LastName': 'Kimani', 'Affiliation': 'College of Computer and Information Science, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Paasche-Orlow', 'Affiliation': 'Section of General Internal Medicine, Department of Medicine, Boston University, Boston, MA, United States.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Bickmore', 'Affiliation': 'College of Computer and Information Science, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Magnani', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, United States.'}]",JMIR cardio,['10.2196/17162']
2044,32887558,A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.,"BACKGROUND


Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH.
METHODS


This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24 years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling.
RESULTS


Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1 years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17 units (95% CI: - 0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
CONCLUSIONS


YPLWH often have poor HIV outcomes, making interventions to improve outcomes in this population critical. This pilot trial of the Tanzania-based SYV intervention demonstrated trends towards improvement in ART adherence and virologic outcomes among YPLWH, supporting efforts to scale the intervention into a fully-powered effectiveness trial.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02888288 . Registered August 9, 2016. Retrospectively registered as first participant enrolled June 16, 2016.",2020,"Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
","['young people living with HIV in Tanzania', 'Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis', 'Mean age was 18.1\u2009years; 51% were female; and 84% were HIV-infected perinatally', 'young people living with HIV (YPLWH']","['A group-based mental health intervention', 'YPLWH', 'Tanzania-based SYV intervention', 'mental health intervention, Sauti ya Vijana (SYV', 'local standard-of-care (SOC']","['ART adherence and virologic outcomes', 'Feasibility and acceptability', 'Virologic suppression rates', 'mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA', 'ART adherence and virologic suppression', 'ART concentration values']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.18628,"Virologic suppression rates (HIV RNA < 400 copies/mL) at baseline were 65% in both arms but increased to 75% in the SYV arm while staying the same in the SOC arm (RR 1.13; 95% CI: 0.94, 1.36).
","[{'ForeName': 'Dorothy E', 'Initials': 'DE', 'LastName': 'Dow', 'Affiliation': 'Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA. Dorothy.dow@duke.edu.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Duke Global Health Institute, Durham, NC, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Coleen K', 'Initials': 'CK', 'LastName': 'Cunningham', 'Affiliation': 'Duke University Medical Center, Pediatrics, Infectious Diseases, Box 3499, Durham, NC, 27710, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': ""O'Donnell"", 'Affiliation': 'Duke University, Center for Health Policy and Inequalities Research, Durham, NC, USA.'}]",BMC public health,['10.1186/s12889-020-09380-3']
2045,32887560,WeChat app-based reinforced education improves the quality of opioid titration treatment of cancer-related pain in outpatients: a randomized control study.,"BACKGROUND


As inadequate pain communication contributes to difficulties in optimizing outcomes of outpatients, we investigated the effect of reinforced education using WeChat App to the opioid titration treatment of cancer-related pain in the outpatient setting.
METHODS


We conducted a prospective study to compare reinforced education using Wechat with care as usual from February to December 2019. Patients in the reinforced education group received reinforced education via Wechat, while those in the control group received care as usual. Effect measurements for both groups are carried out with questionnaires at the baseline and 3 days later. Questionnaires include pain intensity (NRS), treatment-related adverse events, cancer-related quality of life (QOL), sleep (PSQI), satisfaction, anxiety (GAD-7) and depression (PHQ-9). Number of patients whose NRS reduced to less than three points in 24 h was the primary outcomes. Secondary outcomes included treatment-related adverse events, cancer-related quality of life, sleep, satisfaction, anxiety and depression.
RESULTS


Although there was no significant difference regarding pain intensity (NRS) between the two groups at 72 h, the rate of NRS that reduced to less than three points in 24 h was significantly higher in the Wechat group than in the control group. Patients' satisfaction was significantly higher in the Wechat group than in the control group. There was no significant difference between the two groups regarding the other findings at 72 h, including pain intensity (NRS), cancer-related quality of life (QOL), anxiety (GAD-7), depression (PHQ-9), and sleep (PSQI). However, no significant difference was found between the two groups for constipation, nausea, vomiting, dizziness, somnolence, pruritus, loss of consciousness, and death.
CONCLUSIONS


Our results indicated that receiving instructions delivered by Wechat resulted an increased number of patients with good pain control and better satisfaction. The study provided insight into the effectiveness of the reinforced education using a Wechat app delivered by a doctor to outpatients in the titration treatment of cancer-related pain.
TRIAL REGISTRATION


This study was registered at chictr.org (Registration number: ChiCTR1900021150 , Date of Registration: January 30, 2019).",2020,"However, no significant difference was found between the two groups for constipation, nausea, vomiting, dizziness, somnolence, pruritus, loss of consciousness, and death.
",['cancer-related pain in outpatients'],"['reinforced education via Wechat', 'WeChat app-based reinforced education']","['Questionnaires include pain intensity (NRS), treatment-related adverse events, cancer-related quality of life (QOL), sleep (PSQI), satisfaction, anxiety (GAD-7) and depression (PHQ-9', 'pain intensity (NRS), cancer-related quality of life (QOL), anxiety (GAD-7), depression (PHQ-9), and sleep (PSQI', 'rate of NRS', 'pain intensity (NRS', 'number of patients with good pain control and better satisfaction', 'constipation, nausea, vomiting, dizziness, somnolence, pruritus, loss of consciousness, and death', 'treatment-related adverse events, cancer-related quality of life, sleep, satisfaction, anxiety and depression', ""Patients' satisfaction""]","[{'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0041657', 'cui_str': 'Loss of consciousness'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0565873,"However, no significant difference was found between the two groups for constipation, nausea, vomiting, dizziness, somnolence, pruritus, loss of consciousness, and death.
","[{'ForeName': 'Zhiyou', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Yuyao people's Hospital, Ningbo, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Hangzhou first people's Hospital, Hangzhou, China.""}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Department of Pain Medicine, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. fzy1972@zju.edu.cn.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. xmfang@zju.edu.cn.'}]",BMC cancer,['10.1186/s12885-020-07270-w']
2046,32887564,"IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors.","BACKGROUND


Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30 days after admission, compared to standard geriatric rehabilitation alone, in persons admitted to geriatric rehabilitation after a stroke. Secondary objectives include assessing the impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants' experiences and functional status at 3 months.
METHODS


We will conduct a multicenter randomized clinical trial in three geriatric rehabilitation hospitals in Spain. Older adults after mild-moderate stroke without previous severe cognitive impairment or disability will be randomized into the control or intervention group (136 per group, total N = 272). The intervention group will receive 4 sessions of MI by trained nurses, including the design of a personalized rehabilitation plan agreed between stroke survivors and nurses based on stroke survivors´ goals, needs, preferences and capabilities. Main outcome will be the Functional Independence Measure (FIM). In-hospital physical activity will be measured through accelerometers and secondary outcomes using validated scales. The study includes a process evaluation and cost-utility analysis.
DISCUSSION


Final results are expected by end of 2020. This study will provide relevant information on the implementation of MI as a rehabilitation reinforcement tool in older stroke survivors. A potential reduction in post-stroke disability and dependence would increase person's health-related quality of life and well-being and reduce health and social care costs. IMAGINE has the potential to inform practice and policymakers on how to move forward towards shared decision-making and shared responsibilities in the vulnerable population of older stroke survivors.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03434938 , registered on January 2018.",2020,A potential reduction in post-stroke disability and dependence would increase person's health-related quality of life and well-being and reduce health and social care costs.,"['three geriatric rehabilitation hospitals in Spain', 'Older adults after mild-moderate stroke without previous severe cognitive impairment or disability', 'persons admitted to geriatric rehabilitation after a stroke', 'older stroke survivors']","['standard geriatric rehabilitation alone', 'Motivational Interviewing (MI', 'motivational interview']","[""impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants' experiences and functional status at 3\u2009months"", ""person's health-related quality of life and well-being and reduce health and social care costs"", 'Functional Independence Measure (FIM']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0419189', 'cui_str': 'Social care'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}]",3.0,0.101963,A potential reduction in post-stroke disability and dependence would increase person's health-related quality of life and well-being and reduce health and social care costs.,"[{'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Gual', 'Affiliation': ""REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain.""}, {'ForeName': 'Laura Mónica', 'Initials': 'LM', 'LastName': 'Pérez', 'Affiliation': ""REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain.""}, {'ForeName': 'Carmina', 'Initials': 'C', 'LastName': 'Castellano-Tejedor', 'Affiliation': ""REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain. ccastellano@perevirgili.cat.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lusilla-Palacios', 'Affiliation': ""Psychiatry Department, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Castro', 'Affiliation': ""REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain.""}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Soto-Bagaria', 'Affiliation': ""REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Coll-Planas', 'Affiliation': 'Fundació Salut i Envelliment (Foundation on Health and Ageing), Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Roqué', 'Affiliation': 'Fundació Salut i Envelliment (Foundation on Health and Ageing), Universitat Autònoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ana Belen', 'Initials': 'AB', 'LastName': 'Vena', 'Affiliation': 'University Hospital Santa Maria, Lleida, Spain.'}, {'ForeName': 'Benito', 'Initials': 'B', 'LastName': 'Fontecha', 'Affiliation': ""Hospital General de l'Hospitalet (Consorci Sanitari Integral), Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Santiago', 'Affiliation': ""Hospital General de l'Hospitalet (Consorci Sanitari Integral), Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Eva Månsson', 'Initials': 'EM', 'LastName': 'Lexell', 'Affiliation': 'Department of Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Chiatti', 'Affiliation': 'Department of Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Iwarsson', 'Affiliation': 'Department of Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Inzitari', 'Affiliation': ""REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron Institute of Research, Barcelona, Spain.""}]",BMC geriatrics,['10.1186/s12877-020-01694-6']
2047,32887570,A health concept with a social potential: an interview study with nursing home residents.,"BACKGROUND


A qualitative, interview-based study was embedded in a randomized intervention trial, the Older People Exercise and Nutrition (OPEN) study. Participants in the OPEN study were encouraged to conduct sessions of sit-to-stand (STS) exercises combined with Oral Nutritional Supplements (ONS) intake. The aim was to describe the older persons' perceptions and experiences of being given the daily opportunity to perform the STS exercise and drink ONS.
METHODS


In-depth interviews were conducted in six nursing homes with the participants using a semi-structured interview guide. One or two individual interviews were performed with each included participant. Twenty-three NH residents (16 women and 7 men) participated in the qualitative study. Their ages ranged between 76 and 96 years, and their Mini Mental State Examination (MMSE) scored between 8 and 29. The transcribed interviews and field notes written during the visits were analyzed inductively following a constant comparative method described in Grounded Theory.
RESULTS


The exercise and nutritional intervention was described as highly practical by the NH residents, who claimed it also had a social aspect as they felt acknowledged and empowered to engage others in the combined intervention. Experiences of the intervention ranged from neutral to mainly positive and could be sorted into 5 categories: 1. Perceived hopes and expectations, 2. Health-related driving forces, 3. Appreciated daily activities, 4. A concept easy to perform and integrate into daily life, 5. A beneficial health concept for all. The intervention created perceived benefits on various health aspects due to participants feeling energized and stronger. An overall theme was identified as A health concept with a social potential, as participants feel acknowledged and strong enough to help others.
CONCLUSIONS


The intervention was described by participants as a health concept that could potentially be beneficial for a broader spectrum of NH residents. The findings indicate that health concepts, such as STS/ONS, might contribute to a more meaningful day for older people, even vulnerable NH residents approaching the end of life.
TRIAL REGISTRATION


ClinicalTrials.govIdentifier: NCT02702037 . Date of trial registration February 26, 2016.",2020,"The exercise and nutritional intervention was described as highly practical by the NH residents, who claimed it also had a social aspect as they felt acknowledged and empowered to engage others in the combined intervention.","['Twenty-three NH residents (16 women and 7 men) participated in the qualitative study', 'six nursing homes with the participants using a semi-structured interview guide', 'nursing home residents', 'Older People Exercise and Nutrition (OPEN) study', 'Their ages ranged between 76 and 96\u2009years, and their Mini Mental State Examination (MMSE) scored between 8 and 29']","['STS exercise and drink ONS', 'conduct sessions of sit-to-stand (STS) exercises combined with Oral Nutritional Supplements (ONS) intake']",[],"[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",[],,0.0217036,"The exercise and nutritional intervention was described as highly practical by the NH residents, who claimed it also had a social aspect as they felt acknowledged and empowered to engage others in the combined intervention.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Vikström', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Occupational Therapy, Karolinska Institutet, Stockholm, Sweden. sofia.vikstrom@ki.se.'}, {'ForeName': 'Helena K', 'Initials': 'HK', 'LastName': 'Grönstedt', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cederholm', 'Affiliation': 'Department of Geriatric Medicine, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Franzén', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}, {'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Seiger', 'Affiliation': 'Department of Neurobiology, Care Science and Society, Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Faxén-Irving', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Stockholms Sjukhem R&D unit, Stockholm, Sweden.'}]",BMC geriatrics,['10.1186/s12877-020-01731-4']
2048,32887637,Evaluation of an intervention aimed at supporting new parents: the Baby Newsletter project.,"BACKGROUND


Anticipatory guidance for parents is commonly used to improve parenting skills. The objective of this pre/post-intervention controlled study was to evaluate the effectiveness of a periodic newsletter with advice on childcare and development in improving parenting self-efficacy.
METHODS


This was a non-randomized pre/post-intervention controlled study. All the parents of children born between September 2014 and December 2015 resident in the S. Ilario d'Enza municipality (Italy) received eight Baby Newsletters. Parents resident in other municipalities of the same Health District were the control. Parents with linguistic barriers or with preterm or hospitalized children were excluded. Improvement in parenting self-efficacy was measured through the TOPSE (Tool to Measure Parenting Self-Efficacy) questionnaire during the first week (t0) after delivery and at 5 (t1) and 12 months (t2) of life at two vaccination appointments. A score ranging from 0 to 60 was computed for each of the eight domains investigated by the TOPSE. Variations of each TOPSE score between delivery and 12 months in the two groups were compared, adjusting for parity, education, age of parents, and child's sex, and stratifying by parity and education.
RESULTS /FINDINGS


One hundred thirty-six families accepted to participate in the study. Scores at 12 months were higher than 1 week after delivery in both groups for all TOPSE domains. The improvement was slightly stronger in the Newsletter group for almost all the skills except learning and knowledge [difference in the mean of variation: -0.48 (95% CI: - 3.17; 2.21)]; the difference was significant only for play and enjoyment [2.18 (95% CI: 0.12; 4.25)]. The increase in scores in almost all domains was more pronounced for parents with high education level at first child.
CONCLUSIONS


The intervention was effective in improving parents' ability to play. However, it risks worsening existing differences between parents with high and with low education levels.
TRIAL REGISTRATION


Clinical trial registration: NCT03268408 .",2020,The improvement was slightly stronger in the Newsletter group for almost all the skills except learning and knowledge [difference in the mean of variation:,"[""parents of children born between September 2014 and December 2015 resident in the S. Ilario d'Enza municipality (Italy) received"", 'One hundred thirty-six families accepted to participate in the study', 'Parents with linguistic barriers or with preterm or hospitalized children']","['eight Baby Newsletters', 'TOPSE']","['Parenting Self-Efficacy) questionnaire', 'parenting self-efficacy', 'TOPSE score', 'mean of variation']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",136.0,0.0461917,The improvement was slightly stronger in the Newsletter group for almost all the skills except learning and knowledge [difference in the mean of variation:,"[{'ForeName': 'Costantino', 'Initials': 'C', 'LastName': 'Panza', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Volta', 'Affiliation': 'Primary Care Service, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Broccoli', 'Affiliation': 'Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonvicini', 'Affiliation': 'Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. laura.bonvicini@ausl.re.it.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kendall', 'Affiliation': 'Centre for Health Services Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Marchesi', 'Affiliation': 'Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Giorgi Rossi', 'Affiliation': 'Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}]",Italian journal of pediatrics,['10.1186/s13052-020-00886-5']
2049,32887653,"Effect of chemoprevention by low-dose aspirin of new or recurrent colorectal adenomas in patients with Lynch syndrome (AAS-Lynch): study protocol for a multicenter, double-blind, placebo-controlled randomized controlled trial.","Lynch syndrome (LS) is the most common cause of inherited colorectal cancer (CRC) and confers a high lifetime risk of CRC estimated to be up to 60%. Colonoscopy is recommended every 2 years in LS patients above the 20-25-year-old age bracket, and every year when colonic neoplasia has been detected. Efficient chemoprevention has the potential to represent a cost-effective intervention in these high-risk patients and could allow a delay in colonoscopy surveillance. Several epidemiological studies have shown that regular use of low dose aspirin is associated with a 20 to 30% reduction in the risk of sporadic colonic adenomas and colorectal cancer regardless of family risk. However, in recent large randomized trials in specific populations, aspirin use showed no protection for colorectal cancer. A prospective randomized CAPP-2 trial evaluated the effect of aspirin use in LS patients. The primary analysis of this trial showed no significant decrease in CRC in LS patients under daily aspirin. However, a preplanned secondary analysis after an extended follow-up showed a significant reduced risk of CRC in the aspirin group in the per-protocol analysis. The real effect and clinical benefit of aspirin are still to be consolidated in this population. The AAS-Lynch trial-a prospective, multicentric, double-blind, placebo-controlled, randomized clinical trial-was designed to investigate if daily aspirin therapy, at a dose of 100 or 300 mg, would decrease the occurrence or recurrence of colorectal adenomas in patients under 75 years of age, compared with placebo. TRIAL REGISTRATION: ClinicalTrials.gov NCT02813824 . Registered on 27 June 2016. The trial was prospectively registered.",2020,The primary analysis of this trial showed no significant decrease in CRC in LS patients under daily aspirin.,"['LS patients', 'patients under 75\u2009years of age, compared with', 'patients with Lynch syndrome (AAS-Lynch']","['aspirin therapy', 'placebo', 'chemoprevention by low-dose aspirin', 'aspirin']","['CRC', 'occurrence or recurrence of colorectal adenomas', 'risk of CRC']","[{'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.409244,The primary analysis of this trial showed no significant decrease in CRC in LS patients under daily aspirin.,"[{'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Soualy', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Deutsch', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Benallaoua', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Ait-Omar', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mary', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Helfen', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Boubaya', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unité de Recherche Clinique, Hôpital Avicenne, Bobigny, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Benamouzig', 'Affiliation': 'Service de Gastroentérologie, Hôpital Avicenne, Université Paris 13, 125 Rue de Stalingrad, 93000, Bobigny, France. robert.benamouzig@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04674-8']
2050,32887655,Protocol for the measurement of changes in knowledge and engagement in the stepped wedge cluster randomised trial for childhood obesity prevention in Australia: (Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND)).,"BACKGROUND


Community-based interventions have shown promise in addressing the childhood obesity epidemic. Such efforts rely on the knowledge of key community members and their engagement with the drivers of obesity in their community. This paper presents the protocol for the measurement and evaluation of knowledge and engagement among community leaders within a whole-of-community systems intervention across 10 large intervention communities in Australia.
METHODS


We will investigate the role of stakeholder knowledge and engagement in the implementation and effectiveness of the stepped wedge cluster randomised trial in ten communities in Victoria, Australia. Data will be collected using the Stakeholder-driven Community Diffusion Survey (SDCD) to measure levels of knowledge and engagement prior to commencement (2019), across the three separate levels of governance within the intervention at five time points. Primary outcomes will be baseline overall knowledge and engagement scores across the three levels of governance and change in overall knowledge and engagement over time.
DISCUSSION


We hypothesise there will be heterogeneity between intervention sites on levels of knowledge and engagement and that these differences will be associated with variability in implementation success.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001986268 . Registered on 11 December 2018.",2020,"We will investigate the role of stakeholder knowledge and engagement in the implementation and effectiveness of the stepped wedge cluster randomised trial in ten communities in Victoria, Australia.","['ten communities in Victoria, Australia', '10 large intervention communities in Australia', 'childhood obesity prevention in Australia']",[],['baseline overall knowledge and engagement scores across the three levels of governance and change in overall knowledge and engagement over time'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.106092,"We will investigate the role of stakeholder knowledge and engagement in the implementation and effectiveness of the stepped wedge cluster randomised trial in ten communities in Victoria, Australia.","[{'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia. jill.whelan@deakin.edu.au.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Strugnell', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Allender', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia.'}, {'ForeName': 'Ariella R', 'Initials': 'AR', 'LastName': 'Korn', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Brown', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia.'}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Orellana', 'Affiliation': 'Biostatistics Unit, Deakin University, Geelong, Australia.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Hayward', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia.'}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Brown', 'Affiliation': 'Institute for Health Transformation, Deakin Health Economics, Deakin University, Geelong, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Bell', 'Affiliation': 'Institute for Health Transformation, School of Health and Social Development, Deakin University, Geelong, Australia.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Institute for Health Transformation, Deakin Health Economics, Deakin University, Geelong, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Peeters', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Nichols', 'Affiliation': 'Institute for Health Transformation, Global Obesity Centre, Deakin University, Geelong, Australia.'}]",Trials,['10.1186/s13063-020-04692-6']
2051,32888453,"Durvalumab with first-line chemotherapy in previously untreated malignant pleural mesothelioma (DREAM): a multicentre, single-arm, phase 2 trial with a safety run-in.","BACKGROUND


There is a strong unmet need to improve systemic therapy in mesothelioma. Chemotherapy with cisplatin and pemetrexed improves survival in malignant pleural mesothelioma, and immune checkpoint inhibitors are an emerging treatment in this disease. We aimed to evaluate the activity of durvalumab, an anti-PD-L1 antibody, given during and after first-line chemotherapy with cisplatin and pemetrexed in patients with advanced malignant pleural mesothelioma.
METHODS


DREAM was a multicentre, single-arm, open-label, phase 2 trial done in nine hospitals in Australia. Eligible patients were aged 18 years or older and had histologically confirmed malignant pleural mesothelioma considered unsuitable for cancer-directed surgery, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease as per the modified Response Evaluation Criteria in Solid Tumors version 1.0 (mRECIST) for mesothelioma that was previously untreated with systemic therapy. All histological subtypes were eligible. The first six participants were treated for two cycles in a safety run-in. All participants received cisplatin 75 mg/m 2 , pemetrexed 500 mg/m 2 , and durvalumab 1125 mg intravenously on day 1 of a 3-weekly schedule for a maximum of six cycles. Change from cisplatin to carboplatin with an area under the curve of 5 was permitted. Durvalumab was continued for a maximum of 12 months. The primary endpoint was progression-free survival at 6 months, measured according to mRECIST for malignant pleural mesothelioma and analysed in the intention-to-treat population. Safety analyses included all participants who receive at least one dose of any study drug. This study is registered with the Australia New Zealand Clinical Trials Registry, ACTRN12616001170415.
FINDINGS


Between Dec 28, 2016, and Sept 27, 2017, 55 participants were enrolled. 54 patients were eligible and were followed up for a median of 28·2 months (IQR 26·5-30·2). 31 (57%; 95% CI 44-70) of 54 patients were alive and progression-free at 6 months. The most common grade 3-4 adverse events were neutropenia (seven [13%] patients), nausea (six [11%]), and anaemia (four [7%]). A total of 60 serious adverse events occurred in 29 participants, five of which were considered possibly related to durvalumab. Five patients died during the study treatment; none of these five deaths were attributed to study treatment.
INTERPRETATION


The combination of durvalumab, cisplatin, and pemetrexed has promising activity and an acceptable safety profile that warrants further investigation in a randomised phase 3 trial.
FUNDING


AstraZeneca.",2020,"A total of 60 serious adverse events occurred in 29 participants, five of which were considered possibly related to durvalumab.","['patients with advanced malignant pleural mesothelioma', 'nine hospitals in Australia', 'participants who receive at least one dose of any study drug', 'Eligible patients were aged 18 years or older and had histologically confirmed malignant pleural mesothelioma considered unsuitable for cancer-directed surgery, an Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease as per the modified Response Evaluation Criteria in Solid Tumors version 1.0 (mRECIST) for mesothelioma that was previously untreated with systemic therapy', '54 patients were eligible and were followed up for a median of 28·2 months (IQR 26·5-30·2', 'previously untreated malignant pleural mesothelioma (DREAM', 'Between Dec 28, 2016, and Sept 27, 2017, 55 participants were enrolled']","['cisplatin to carboplatin', 'cisplatin and pemetrexed', 'cisplatin 75 mg/m 2 , pemetrexed 500 mg/m 2 , and durvalumab', 'Chemotherapy with cisplatin and pemetrexed', 'durvalumab, cisplatin, and pemetrexed', 'Durvalumab with first-line chemotherapy']","['nausea', 'alive and progression-free', 'neutropenia', 'anaemia', 'progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854889', 'cui_str': 'Pleural mesothelioma malignant advanced'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0025500', 'cui_str': 'Mesothelioma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013117', 'cui_str': 'Dream'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",55.0,0.245365,"A total of 60 serious adverse events occurred in 29 participants, five of which were considered possibly related to durvalumab.","[{'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Nowak', 'Affiliation': 'Sir Charles Gairdner Hospital, Nedlands, WA, Australia; National Centre for Asbestos Related Diseases, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia. Electronic address: anna.nowak@uwa.edu.au.'}, {'ForeName': 'W Joost', 'Initials': 'WJ', 'LastName': 'Lesterhuis', 'Affiliation': 'National Centre for Asbestos Related Diseases, Perth, WA, Australia; School of Biomedical Sciences, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Peey-Sei', 'Initials': 'PS', 'LastName': 'Kok', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Brett Gm', 'Initials': 'BG', 'LastName': 'Hughes', 'Affiliation': 'The Prince Charles Hospital and University of Queensland, Brisbane, QLD, Australia; University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Deme J', 'Initials': 'DJ', 'LastName': 'Karikios', 'Affiliation': 'Nepean Hospital, Kingswood, NSW, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'John', 'Affiliation': 'Olivia Newton-John Cancer Research Institute, Austin Hospital, Heidelberg, VIC, Australia.'}, {'ForeName': 'Steven C-H', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Connull', 'Initials': 'C', 'LastName': 'Leslie', 'Affiliation': 'PathWest Laboratory Medicine, Nedlands, WA, Australia.'}, {'ForeName': 'Alistair M', 'Initials': 'AM', 'LastName': 'Cook', 'Affiliation': 'National Centre for Asbestos Related Diseases, Perth, WA, Australia; Medical School, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital and Northern Cancer Institute, Sydney, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Briscoe', 'Affiliation': 'Mid North Coast Cancer Institute, Coffs Harbour Health Campus, Coffs Harbour, NSW, Australia.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': ""O'Byrne"", 'Affiliation': 'Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia.'}, {'ForeName': 'Christos S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'Flinders Medical Centre and Flinders University, Bedford Park, SA, Australia.'}, {'ForeName': 'Wei-Sen', 'Initials': 'WS', 'LastName': 'Lam', 'Affiliation': 'Department of Medical Oncology, Fiona Stanley Hospital and Western Australia Country Health Service, Perth, WA, Australia.'}, {'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Langford', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Yip', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Stockler', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30462-9']
2052,32888454,"Carboplatin plus etoposide versus topotecan as second-line treatment for patients with sensitive relapsed small-cell lung cancer: an open-label, multicentre, randomised, phase 3 trial.","BACKGROUND


Topotecan is currently the only drug approved in Europe in a second-line setting for the treatment of small-cell lung cancer. This study investigated whether the doublet of carboplatin plus etoposide was superior to topotecan as a second-line treatment in patients with sensitive relapsed small-cell lung cancer.
METHODS


In this open-label, randomised, phase 3 trial done in 38 hospitals in France, we enrolled patients with histologically or cytologically confirmed advanced stage IV or locally relapsed small-cell lung cancer, who responded to first-line platinum plus etoposide treatment, but who had disease relapse or progression at least 90 days after completion of first-line treatment. Eligible patients were aged 18 years or older and had an Eastern Cooperative Oncology Group performance status 0-2. Enrolled patients were randomly assigned (1:1) to receive combination carboplatin plus etoposide (six cycles of intravenous carboplatin [area under the curve 5 mg/mL per min] on day 1 plus intravenous etoposide [100 mg/m 2  from day 1 to day 3]) or oral topotecan (2·3 mg/m 2  from day 1 to day 5, for six cycles). Randomisation was done using the minimisation method with biased-coin balancing for ECOG performance status, response to the first-line chemotherapy, and treatment centre. The primary endpoint was progression-free survival, which was centrally reviewed and analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02738346.
FINDINGS


Between July 18, 2013, and July 2, 2018, we enrolled and randomly assigned 164 patients (82 in each study group). One patient from each group withdrew consent, therefore 162 patients (81 in each group) were included in the intention-to-treat population. With a median follow-up of 22·7 months (IQR 20·0-37·3), median progression-free survival was significantly longer in the combination chemotherapy group than in the topotecan group (4·7 months, 90% CI 3·9-5·5 vs 2·7 months, 2·3-3·2; stratified hazard ratio 0·57, 90% CI 0·41-0·73; p=0·0041). The most frequent grade 3-4 adverse events were neutropenia (18 [22%] of 81 patients in the topotecan group vs 11 [14%] of 81 patients in the combination chemotherapy group), thrombocytopenia (29 [36%] vs 25 [31%]), anaemia (17 [21%] vs 20 [25%]), febrile neutropenia (nine [11%] vs five [6%]), and asthenia (eight [10%] vs seven [9%]). Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
INTERPRETATION


Our results suggest that carboplatin plus etoposide rechallenge can be considered as a reasonable second-line chemotherapy option for patients with sensitive relapsed small-cell lung cancer.
FUNDING


Amgen and the French Lung Cancer Group (Groupe Français de Pneumo-Cancérologie).",2020,"Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
","['Between July 18, 2013, and July 2, 2018, we enrolled and randomly assigned 164 patients (82 in each study group', 'patients with sensitive relapsed small-cell lung cancer', '162 patients (81 in each group) were included in the intention-to-treat population', '38 hospitals in France, we enrolled patients with histologically or cytologically confirmed advanced stage IV or locally relapsed small-cell lung cancer, who responded to first-line platinum plus etoposide treatment, but who had disease relapse or progression at least 90 days after completion of first-line treatment', 'Eligible patients were aged 18 years or older and had an Eastern Cooperative Oncology Group performance status 0-2']","['carboplatin plus etoposide', 'oral topotecan', 'Carboplatin plus etoposide versus topotecan', 'combination carboplatin plus etoposide (six cycles of intravenous carboplatin [area under the curve 5 mg/mL per min] on day 1 plus intravenous etoposide']","['febrile neutropenia', 'thrombocytopenia', 'asthenia', 'deaths', 'neutropenia', 'median progression-free survival', 'anaemia', 'progression-free survival', 'febrile neutropenia with sepsis']","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278727', 'cui_str': 'Small cell lung cancer recurrent'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",164.0,0.170259,"Two treatment-related deaths occurred in the topotecan group (both were febrile neutropenia with sepsis) and no treatment-related deaths occurred in the combination group.
","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Baize', 'Affiliation': ""Service de Cancérologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Aix-Marseille University, Marseille, France; Department of Multidisciplinary Oncology and Therapeutic Innovations, APHM, Hôpital Nord, Marseille, France; Department of Multidisciplinary Oncology and Therapeutic Innovations, Hôpital Nord, Marseille, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Geier', 'Affiliation': 'Service de Pneumologie, CHU Brest, Brest, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lena', 'Affiliation': 'Service de Pneumologie, CHU Rennes, Rennes, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Janicot', 'Affiliation': 'Service de Pneumologie, CHU Clermont-Ferrand, Clermont Ferrand, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vergnenegre', 'Affiliation': 'Service de Pneumologie, CHU Limoges, Limoges, France.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Crequit', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Beauvais, Beauvais, France.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Lamy', 'Affiliation': 'Service de Pneumologie, CH Bretagne Sud, Lorient, France.'}, {'ForeName': 'Jean-Bernard', 'Initials': 'JB', 'LastName': 'Auliac', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Letreut', 'Affiliation': 'Service de Pneumologie, Hôpital Européen, Marseille, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Le Caer', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Radj', 'Initials': 'R', 'LastName': 'Gervais', 'Affiliation': ""Service d'Oncologie, Centre François Baclesse, Caen, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dansin', 'Affiliation': ""Service d'Oncologie, Centre Oscar Lambret, Lille, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Madroszyk', 'Affiliation': ""Service d'Oncologie, Institut Paoli-Calmettes, Marseille, France.""}, {'ForeName': 'Patrick-Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Gwenaëlle', 'Initials': 'G', 'LastName': 'Le Garff', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Saint Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Falchero', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Villefranche de Rouergue, Villefranche, France.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Berard', 'Affiliation': ""Service de Pneumologie, Hôpital d'instruction des armées Sainte-Anne, Toulon, France.""}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Schott', 'Affiliation': ""Service d'Oncologie, Centre Paul Strauss, Strasbourg, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Saulnier', 'Affiliation': ""Département de Biostatistiques et Méthodologie, Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Chouaid', 'Affiliation': 'Service de Pneumologie, CHI Créteil, Créteil, France; Institut Mondor de Recherche Biomédicale, U955 Inserm-Université Paris Est Créteil, Créteil, France. Electronic address: christos.chouaid@chicreteil.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30461-7']
2053,32888563,The influence of menthol dose on human temperature regulation and perception.,"INTRODUCTION


This study assessed the influence of High (H, 4.13%), Medium (M, 2.0%) and Low (L, 0.1%) doses of menthol on temperature perception and regulation, compared to a Placebo Condition (P).
METHOD


Sixteen participants underwent the aforementioned conditions on four separate days. During each test participants rested supine (Environmental conditions: 30 °C, 50% rh) for 30-min before 40 mL of L, M, H or P gel was applied to the anterior upper body, then rested 30-min thereafter. Primary measures included thermal sensation (TS), thermal comfort (TC), irritation (IRR), rectal temperature (Tre), and skin temperature (chest, forearm, thigh, calf), and EMG (trapezius, pectoralis major, sternocleidomastoid). The area under the curve (AUC) from minute 30 to 60 was compared between conditions using relevant non/parametric tests (alpha level = 0.05).
RESULTS


A cooling trend in Tre was observed following Placebo gel application, but this significantly (p < 0.05) reversed into a heat storage response in M and H. Both TS and TC significantly differed by condition (p < 0.001) in a dose-dependent manner, with L, M, and H doses eliciting significantly cooler sensations and more discomfort than P (p < 0.05). Irritation significantly differed by condition (p < 0.01) in a dose-dependent manner, with L and M eliciting significantly greater irritation than P (p < 0.01). No other differences were observed.
CONCLUSIONS


Menthol exerts perceptual and thermoregulatory effects independent of skin temperature. A menthol dose-dependent perceptual cooling effect was evident with possible saturation at the moderate dose. A dose-dependent alteration in deep body temperature was also evident.",2020,"Irritation significantly differed by condition (p < 0.01) in a dose-dependent manner, with L and M eliciting significantly greater irritation than P (p < 0.01).",['Sixteen participants underwent the aforementioned conditions on four separate days'],['menthol'],"['cooler sensations and more discomfort', 'area under the curve (AUC', 'deep body temperature', 'heat storage response', 'thermal sensation (TS), thermal comfort (TC), irritation (IRR), rectal temperature (Tre), and skin temperature (chest, forearm, thigh, calf), and EMG (trapezius, pectoralis major, sternocleidomastoid', 'Irritation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}]",16.0,0.0326472,"Irritation significantly differed by condition (p < 0.01) in a dose-dependent manner, with L and M eliciting significantly greater irritation than P (p < 0.01).","[{'ForeName': 'D Jason', 'Initials': 'DJ', 'LastName': 'Gillis', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, 225 Canal Street, Salem, MA, 01970, USA. Electronic address: Jason.gillis@salemstate.edu.'}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Capone', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, 225 Canal Street, Salem, MA, 01970, USA.'}, {'ForeName': 'Kacey', 'Initials': 'K', 'LastName': 'Nestor', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, 225 Canal Street, Salem, MA, 01970, USA.'}, {'ForeName': 'Mitchel', 'Initials': 'M', 'LastName': 'Snell', 'Affiliation': 'Human Performance Laboratory, Department of Sport and Movement Science, Salem State University, 225 Canal Street, Salem, MA, 01970, USA.'}]",Journal of thermal biology,['10.1016/j.jtherbio.2020.102659']
2054,32889329,Improving reproductive outcomes of intrauterine insemination: Does endometrial scratch injury help? A randomised controlled trial.,"OBJECTIVE(S)


Current evidence suggests that endometrial injury improves clinical pregnancy rate while having no effect on miscarriages in women undergoing IVF/ICSI. However, there is no substantial evidence to advocate the use of endometrial injury to benefit the outcomes of IUI treatment. Additionally, there is no clear consensus about the ideal timing, underlying mechanism and optimum intensity of endometrial injury required. The study examines the effect of intentional endometrial injury/scratch in the early proliferative phase of stimulated cycle on reproductive outcomes (clinical and ongoing pregnancy rates and miscarriage occurrence) of intra-uterine insemination treatment (IUI).
STUDY DESIGN, SIZE, DURATION


This prospective, randomized control interventional study was conducted in a tertiary level teaching institution from April 2018 to February 2020. 150 eligible couples requiring IUI treatment who agreed to participate were randomly allocated on 1:1 basis to either control or intervention group. The trial participants received up to 3 cycles ovulation induction with clomiphene citrate and intra-uterine insemination. In addition, women in intervention group were subjected to endometrial scratch injury on day 6-7 of their stimulated cycle. 154 cycles in control arm and 128 cycles in intervention group were analyzed for clinical pregnancy, miscarriages and pain experienced by the women during endometrial scratch injury using the statistical package SPSS (version 21).
RESULT


Similar cumulative clinical pregnancy rates (12.5% Vs 13.6%, RR 1.21, 95% CI 0.44-3.37, p = 0.713), biochemical pregnancy rates (17.1% vs 22.9%, RR 1.43, CI 0.59-3.47, p = 0.421) and ongoing pregnancy rates (10.93% Vs 11.47%, RR 1.05, CI 0.35-3.21, p = 924) were observed in control and intervention arms. Likewise, the relative risk of miscarriage occurrence in the intervention arm was 1.32 (95% CI 0.39-4.32, p = 1.000) which was not statistically different from control group. Mean pain score of 6.93 on numerical pain rating scale was experienced by women whilst having endometrial scratch injury.
CONCLUSIONS


There is insufficient evidence to defend the use of endometrial scratch injury in intra-uterine insemination treatment, as it is moderately painful and have uncertain beneficial influence on reproductive outcomes.",2020,"Vs 13.6%, RR 1.21, 95% CI 0.44-3.37, p = 0.713), biochemical pregnancy rates (17.1% vs 22.9%, RR 1.43, CI 0.59-3.47, p = 0.421) and ongoing pregnancy rates (10.93% Vs 11.47%, RR 1.05, CI 0.35-3.21, p = 924) were observed in control and intervention arms.","['tertiary level teaching institution from April 2018 to February 2020', '150 eligible couples requiring IUI treatment who agreed to participate']","['intrauterine insemination', 'intentional endometrial injury/scratch', 'intra-uterine insemination treatment (IUI', 'clomiphene citrate and intra-uterine insemination']","['reproductive outcomes (clinical and ongoing pregnancy rates and miscarriage occurrence', 'clinical pregnancy rate', 'Mean pain score', 'cumulative clinical pregnancy rates', 'ongoing pregnancy rates', 'numerical pain rating scale', 'biochemical pregnancy rates', 'relative risk of miscarriage occurrence']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}]","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",150.0,0.317085,"Vs 13.6%, RR 1.21, 95% CI 0.44-3.37, p = 0.713), biochemical pregnancy rates (17.1% vs 22.9%, RR 1.43, CI 0.59-3.47, p = 0.421) and ongoing pregnancy rates (10.93% Vs 11.47%, RR 1.05, CI 0.35-3.21, p = 924) were observed in control and intervention arms.","[{'ForeName': 'Navdeep Kaur', 'Initials': 'NK', 'LastName': 'Ghuman', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India. Electronic address: drnavdeepghuman@gmail.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Raikar', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India.'}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India. Electronic address: drpratibha69@hotmail.com.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Gothwal', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Jodhpur, 342005, India.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.08.010']
2055,32889373,Benefit-harm balance of fingolimod in patients with MS: A modelling study based on FREEDOMS.,"BACKGROUND


Fingolimod lowers the number of relapses in multiple sclerosis (MS) patients and slows down disease progression, but causes a broad spectrum of side effects. Our aim was to estimate the benefit-harm balance of fingolimod using individual patient data from FREEDOMS, a randomized controlled trial that compared two different dosages of fingolimod to placebo.
METHODS


We modelled the health status of patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health). The model considered Expanded Disability Status Scale measurements, relapses and adverse events. We compared the mean health status between arms, and the proportion of trial participants for whom health declined or improved compared to baseline by a predefined minimal important difference of 4.6 or more.
RESULTS


The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2). Patients on fingolimod 0.5mg were 0.53 (95% CI 0.40-0.72, p<0.001) times less likely to have a relevant decline in health status compared to patients on placebo, corresponding to a number needed to treat of 8 to prevent one relevant decline in health status. All sensitivity analyses favoured fingolimod 0.5mg.
CONCLUSION


Although fingolimod's net benefit did not reach the clinical relevance on average, the decreased risk for a decline in health over two years may be relevant. This approach could be applied to other MS drugs and provide an objective evidence base for guideline recommendations.",2020,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","['patients with MS', 'patients over two years on a scale ranging from 0 (worst health or death) to 100 (maximum health']","['placebo', 'fingolimod to placebo']","['mean health status', 'Disability Status Scale measurements, relapses and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.143984,"The main analysis showed a net benefit for fingolimod 0.5mg compared to placebo, with an average health status difference over two years of 2.7 (95% CI 2.2 to 3.2).","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Spanu', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Hélène E', 'Initials': 'HE', 'LastName': 'Aschmann', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Kesselring', 'Affiliation': 'RehaKliniken Valens, Zurich, Switzerland.'}, {'ForeName': 'Milo A', 'Initials': 'MA', 'LastName': 'Puhan', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland. Electronic address: miloalan.puhan@uzh.ch.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102464']
2056,32889413,Outcomes of individualized goal-directed therapy based on cerebral oxygen balance in high-risk patients undergoing cardiac surgery: A randomized controlled trial.,"STUDY OBJECTIVE


To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity.
DESIGN


This was a prospective, randomized, controlled study.
SETTING


The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018.
PATIENTS


146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled.
INTERVENTION


Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO 2 ) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB.
MEASUREMENTS


The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications.
MAIN RESULTS


128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001).
CONCLUSIONS


In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.",2020,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","['high-risk surgical patients', 'high-risk patients undergoing cardiac surgery', 'The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018', '146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled']","['individualized goal-directed therapy', 'cardiac surgery, individualized GDT therapy', 'individualized goal-directed therapy (GDT', 'individualized GDT group or usual care group']","['mean arterial pressure (MAP', 'Early morbidity', 'morbidity', 'cerebral oxygen balance', 'regional cerebral oxygen saturation (rScO 2 ) level', 'bispectral index (BIS', 'composite endpoint of 30-day mortality and major postoperative complications']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",,0.315518,"Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15).","[{'ForeName': 'Xin-Qi', 'Initials': 'XQ', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_mz_cheng@126.com.'}, {'ForeName': 'Jun-Yan', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacology, Anhui Medical University, 230032 Hefei, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'You-Mei', 'Initials': 'YM', 'LastName': 'Zuo', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China.'}, {'ForeName': 'Er-Wei', 'Initials': 'EW', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_guew_mz@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110032']
2057,32892595,[Clinical study of sequential glucocorticoids in the treatment of acute mercury poisoning complicated with interstitial pneumonia].,"Objective:  To study the clinical efficacy of sequential glucocorticoids in the treatment of acute mercury poisoning complicated with interstitial pneumonia.  Methods:  Retrospective analysis of 37 patients with acute mercury poisoning complicated with interstitial pneumonia admitted from January 2009 to April 2019, including the sequential treatment group (15 cases) and the conventional treatment group (22 cases) , all patients were treated with sodium dimercaptopropane sulfonate, and given anti-inflammatory, liver-protecting and other drugs for symptomatic treatment. The conventional treatment group was given methylprednisolone 1mg/kg once a day for 5-7 days. The sequential treatment group was given 1 mg/kg of methylprednisolone once a day for 5-7 days, then gradually reduced to 20 mg, and the total course of treatment was 14-21 days. To observe the changes of clinical symptoms, signs, lung function including forced vital capacity (FVC) , forced expiratory volume in the first second (FEV(1)) and ratio of forced expiratory volume in the first second to forced vital capacity (FEV(1)/FVC) , and chest CT indexes before and after treatment in the two groups.  Results:  The clinical symptoms and signs of the two groups were significantly improved compared with those before treatment, and there was no significant difference between the apparent efficiency and the total effective rate of the two groups ( P >0.05) . The FVC, FEV(1), and FEV(1)/FVC of the two groups were significantly higher than those before treatment. After treatment, the indexes of the sequential treatment group were significantly higher than that of the conventional treatment group, and the difference was statistically significant ( P <0.05) . The apparent efficiency (93.3%, 14/15) of CT lesions in the sequential treatment group was significantly higher than those of the conventional treatment group (59.1%, 13/22) , and the difference was statistically significant ( P < 0.05) .  Conclusion:  Sequential glucocorticoid treatment of acute mercury poisoning complicated with interstitial pneumonia could improve the effect of clinical signs and symptoms which is equal to conventional treatment, but it could better promote the recovery of lung function and the absorption of lung lesions.",2020,"The apparent efficiency (93.3%, 14/15) of CT lesions in the sequential treatment group was significantly higher than those of the conventional treatment group (59.1%, 13/22) , and the difference was statistically significant ( P < 0.05) .  ","['37 patients with acute mercury poisoning complicated with interstitial pneumonia admitted from January 2009 to April 2019, including the sequential treatment group (15 cases) and the conventional treatment group (22 cases', 'acute mercury poisoning complicated with interstitial pneumonia']","['sodium dimercaptopropane sulfonate, and given anti-inflammatory, liver-protecting and other drugs for symptomatic treatment', 'methylprednisolone', 'glucocorticoid treatment', 'sequential glucocorticoids']","['CT lesions', 'FVC, FEV(1), and FEV(1)/FVC', 'total effective rate', 'clinical symptoms, signs, lung function including forced vital capacity (FVC) , forced expiratory volume in the first second (FEV(1)) and ratio of forced expiratory volume in the first second to forced vital capacity (FEV(1)/FVC) , and chest CT indexes', 'apparent efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0025427', 'cui_str': 'Toxic effect of mercury and its compounds'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0002072', 'cui_str': 'Alkyl Sulfonates'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",37.0,0.0157687,"The apparent efficiency (93.3%, 14/15) of CT lesions in the sequential treatment group was significantly higher than those of the conventional treatment group (59.1%, 13/22) , and the difference was statistically significant ( P < 0.05) .  ","[{'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Fan', 'Affiliation': 'Department of Occupational Diseases, Yantai Shan Hospital, Yantai 264025, China.'}, {'ForeName': 'H Y', 'Initials': 'HY', 'LastName': 'Shao', 'Affiliation': 'Department of Occupational Diseases, Yantai Shan Hospital, Yantai 264025, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Occupational Diseases, Yantai Shan Hospital, Yantai 264025, China.'}, {'ForeName': 'Z P', 'Initials': 'ZP', 'LastName': 'Dong', 'Affiliation': 'Department of Occupational Diseases, Yantai Shan Hospital, Yantai 264025, China.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational Diseases, Yantai Shan Hospital, Yantai 264025, China.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Shi', 'Affiliation': 'Department of Occupational Diseases, Yantai Shan Hospital, Yantai 264025, China.'}]",Zhonghua lao dong wei sheng zhi ye bing za zhi = Zhonghua laodong weisheng zhiyebing zazhi = Chinese journal of industrial hygiene and occupational diseases,['10.3760/cma.j.cn121094-20191009-00468']
2058,32892604,[Efficacy of stellate ganglion block in perioperative period of patients with chronic sinusitis and hypertension].,"Objective:  To observe the perioperative efficacy of stellate ganglion block (SGB) in functional endoscopic sinus surgery (FESS) in chronic sinusitis patients with hypertension.  Methods:  A total of 60 patients with chronic sinusitis complicated with hypertension who were scheduled to undergo FESS in the Department of Otorhinolaryngology, the First Affiliated Hospital of Soochow University from April 2018 to December 2019 were selected and divided into SGB group and control group by random number table method. SGB were performed at 24 hours before surgery and induction of general anesthesia alternately, while the control group was not treated. During the operation, controlled hypotension were performed in both groups. Hemodynamic parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and heart rate (HR) were recorded at 24 hours before surgery(T(0)), before anesthesia induction (T(1)), at the beginning of surgery (T(2)), at the end of surgery (T(3)), and at 24 hours after surgery(T(4)).Plasma epinephrine and norepinephrine concentrations were measured at T(0), T(1), T(3) and T(4). The dosage of anesthesia and other drugs, operative time, bleeding amount and extubation time were recorded, while the quality of the operative field was evaluated. VAS scores were assessed at 1, 6 and 24 hours after surgery.  Results:  In the SGB group, SBP, DBP and MAP in T(1), T(2), T(3), T(4) and HR in T(1), T(4) were lower than those in the control group (all  P< 0.05). Compared with T(0), SBP, DBP, MAP and HR in T(1), T(2), T(3), T(4) all decreased in SGB group (all  P< 0.05); In the control group, SBP, DBP and MAP only decreased in T(2) and T(3), and HR fluctuated significantly ( P< 0.05). In the SGB group, plasma epinephrine and norepinephrine concentrations at T(1), T(3) and T(4) were lower than those in the control group ( P< 0.05). Compared with T(0), plasma epinephrine and norepinephrine concentrations in the SGB group fluctuated in positive and negative phases, while those in the control group increased ( P< 0.05). The pain scores in SGB group at 6 and 24 hours after surgery were 1.3±0.7 and 2.6±0.9, which were lower than 1.7±0.7 and 3.1±0.9 in the control group ( t= -2.290, -2.050, all  P< 0.05).  Conclusion:  SGB may effectively improve hemodynamics, maintain homeostasis, reduce anesthesia and surgical complications in patients with chronic sinusitis and hypertension in perioperative period.",2020,"In the control group, SBP, DBP and MAP only decreased in T(2) and T(3), and HR fluctuated significantly ( P< 0.05).","['patients with chronic sinusitis and hypertension in perioperative period', '60 patients with chronic sinusitis complicated with hypertension who were scheduled to undergo FESS in the Department of Otorhinolaryngology, the First Affiliated Hospital of Soochow University from April 2018 to December 2019', 'patients with chronic sinusitis and hypertension', 'chronic sinusitis patients with hypertension']","['stellate ganglion block (SGB', 'stellate ganglion block', 'functional endoscopic sinus surgery (FESS', 'SGB group and control group by random number table method']","['SBP, DBP and MAP only decreased in T(2) and T(3), and HR fluctuated', 'operative time, bleeding amount and extubation time', 'plasma epinephrine and norepinephrine concentrations at T(1), T(3) and T(4', 'VAS scores', 'plasma epinephrine and norepinephrine concentrations', 'SBP, DBP and MAP in T(1), T(2), T(3), T(4) and HR in T(1), T(4', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP) and heart rate (HR', 'SBP, DBP, MAP and HR in T(1), T(2), T(3), T(4', 'pain scores', 'anesthesia induction (T(1)), at the beginning of surgery (T(2)), at the end of surgery (T(3)), and at 24 hours after surgery(T(4)).Plasma epinephrine and norepinephrine concentrations were measured at T(0), T(1), T(3) and T(4']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231241', 'cui_str': 'Fluctuating'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",60.0,0.0149357,"In the control group, SBP, DBP and MAP only decreased in T(2) and T(3), and HR fluctuated significantly ( P< 0.05).","[{'ForeName': 'X Q', 'Initials': 'XQ', 'LastName': 'Hu', 'Affiliation': 'Department of Otorhinolaryngology, the First Affiliated Hospital of Soochow University, Suzhou 215006, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Soochow University, Suzhou 215006, China.'}, {'ForeName': 'W X', 'Initials': 'WX', 'LastName': 'Ma', 'Affiliation': 'Department of Quality Management, the First Affiliated Hospital of Soochow University, Suzhou 215006, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Soochow University, Suzhou 215006, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200513-01529']
2059,32892605,[Application of thoracoscopy-guided thoracic paravertebral block for analgesia after single-port video-assisted pulmonary lobectomy].,"Objective:  To investigate the effects of thoracoscopy-guided thoracic paravertebral block for analgesia after single-port video-assisted pulmonary lobectomy.  Methods:  From December 2019 to April 2020, 60 patients receiving single-port video-assisted pulmonary lobectomy at Ningbo Medical Center Lihuili Hospital were selected. The patients were randomly and equally divided into control group and paravertebral block group using a random number table. Patients of paravertebral block group were injected into the thoracic 4-5 intercostal, paravertebral 1 cm using 0.375% ropivacaine (20 ml) with thoracoscopy-guided at the end of surgery, while patients of control group were given patient controlled intravenous analgesia (PCIA). Postoperative visual analogue scale (VAS) and Ramsay sedation scale were recorded at 6, 12, 24, 36, 48 h after the surgery. The incidence of postoperative adverse reactions, additional dose and times of pethidine, the time to resume eating, the rate of postoperative active cough, the first time to get out of bed after surgery and postoperative hospital stay of two groups' patients were recorded.  t  test and chisquare test were used for statistical analysis.  Results:  The VAS score of paravertebral block group were lower than those of control group at all time points (all  P< 0.05). The Ramsay sedation scale of paravertebral block group were higher than those of control group at all time points (all  P< 0.05). The additional dose and times of pethidine of paravertebral block group were (8.2±2.3) mg and (0.2±0.1) time, which were lower than (87.8±15.3) mg and (1.8±0.3) time of control group, the differences were statistically significant ( t= 28.91, 34.37, all  P< 0.05). Incidence of nausea, vomiting and pruritus of paravertebral block group were 10.0%, 6.7% and 0, which were lower than 40.0%, 30.0% and 13.3% of control group, the differences were statistically significant (χ(2)=7.20, 5.45, 4.29, all  P< 0.05). The rate of postoperative active cough of paravertebral block group was 33.3%, which was higher than 10.0% of control group, the difference was statistically significant (χ(2)=4.81,  P< 0.05). The time to resume eating, the first time to get out of bed after surgery and postoperative hospital stay were (6.5±0.4) h, (20.9±3.1) h and (4.6±1.0) d, which were lower than (8.5±0.7) h, (28.6±4.8) h and (6.1±1.3) d of control group, the differences were statistically significant ( t= 13.47, 7.39, 4.19, all  P< 0.05).  Conclusion:  Thoracic paravertebral block under thoracoscopy-guided can effectively reduce the postoperative pain of single-port thoracoscopic lobectomy, with fewer adverse reactions, and is beneficial to postoperative recovery.",2020,The Ramsay sedation scale of paravertebral block group were higher than those of control group at all time points (all  P< 0.05).,"['Methods:  From December 2019 to April 2020, 60 patients receiving single-port video-assisted pulmonary lobectomy at Ningbo Medical Center Lihuili Hospital were selected']","['thoracic 4-5 intercostal, paravertebral 1 cm using 0.375% ropivacaine (20 ml) with thoracoscopy-guided at the end of surgery, while patients of control group were given patient controlled intravenous analgesia (PCIA', 'pethidine', 'thoracoscopy-guided thoracic paravertebral block', 'Thoracic paravertebral block under thoracoscopy-guided', 'control group and paravertebral block group using a random number table']","['rate of postoperative active cough', 'time to resume eating, the first time to get out of bed after surgery and postoperative hospital stay', 'postoperative pain', 'Ramsay sedation scale', 'Postoperative visual analogue scale (VAS) and Ramsay sedation scale', 'VAS score of paravertebral block', 'Incidence of nausea, vomiting and pruritus of paravertebral block', 'postoperative adverse reactions, additional dose and times of pethidine, the time to resume eating, the rate of postoperative active cough, the first time to get out of bed after surgery and postoperative hospital stay']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0039989', 'cui_str': 'Thoracoscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039224', 'cui_str': 'Table'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}]",,0.0180607,The Ramsay sedation scale of paravertebral block group were higher than those of control group at all time points (all  P< 0.05).,"[{'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo 315040, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo 315040, China.'}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Shen', 'Affiliation': 'Department of Thoracic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo 315040, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Ningbo Medical Center Lihuili Hospital, Ningbo 315040, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Department of Thoracic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo 315040, China.'}, {'ForeName': 'J X', 'Initials': 'JX', 'LastName': 'He', 'Affiliation': 'Department of Thoracic Surgery, Ningbo Medical Center Lihuili Hospital, Ningbo 315040, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200525-01647']
2060,32892606,[Blood loss in total knee arthroplasty using computer-assisted navigation or 3D-printed patient-specific instruments].,"Objective:  To compare the perioperative blood loss in patients undergoing a total knee arthroplasty (TKA) across three different techniques: computer-assisted navigation surgery (CAS), patient specific instrumentation (PSI) and conventional instrumentation (CI).  Methods:  Ninety consecutive patients with severe knee osteoarthritis who underwent unilateral primary TKA in Peking University Third Hospital Orthopedics Department from January 2018 to December 2018 were enrolled in this prospective study. The patients were randomly divided into three groups (30 case in each group): CAS-TKA group, PSI-TKA group and CI-TKA group. The study measured intraoperative blood loss, total blood loss, hidden blood loss, decreases of hemoglobin and hematocrit, and the post-TKA blood transfusions in the three groups. One-way ANOVA was used to detect the differences among the cohorts, and LSD was used for the post-hoc test.  Results:  The overall intraoperative blood loss of all patients was 6 ml (5~8 ml). The mean total blood loss and hidden blood loss in CAS-TKA group, PSI-TKA group and CI-TKA group was (1 147.0±301.8) and (1 140.1±301.9)ml, (1 044.3±454.1) and (1 038.5±454.0)ml, (1 154.0±483.6) and (1 145.3±482.7)ml, respectively; there was no significant differences among the three groups ( F= 0.639, 0.616, both  P> 0.05). There were no patients who received allogeneic blood transfusion. There were no significant differences in decrease of hemoglobin and hematocrit among the three groups neither (both  P> 0.05).  Conclusions:  Compared with conventional TKA, CAS and PSI does not increase the total blood loss of TKA. However, they both demonstrate a potential benefit in reducing blood loss of TKA.",2020,There were no significant differences in decrease of hemoglobin and hematocrit among the three groups neither (both  P> 0.05).  ,"['patients undergoing a total knee arthroplasty (TKA) across three different techniques', 'Ninety consecutive patients with severe knee osteoarthritis who underwent unilateral primary TKA in Peking University Third Hospital Orthopedics Department from January 2018 to December 2018']","['CAS-TKA group, PSI-TKA group and CI-TKA', 'computer-assisted navigation surgery (CAS), patient specific instrumentation (PSI) and conventional instrumentation (CI', 'computer-assisted navigation or 3D-printed patient-specific instruments', 'conventional TKA, CAS and PSI']","['perioperative blood loss', 'total blood loss of TKA', 'overall intraoperative blood loss', 'allogeneic blood transfusion', 'intraoperative blood loss, total blood loss, hidden blood loss, decreases of hemoglobin and hematocrit, and the post-TKA blood transfusions', 'mean total blood loss and hidden blood loss', 'blood loss of TKA', 'hemoglobin and hematocrit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}]","[{'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",90.0,0.0271257,There were no significant differences in decrease of hemoglobin and hematocrit among the three groups neither (both  P> 0.05).  ,"[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Geng', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Tao', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200216-00304']
2061,32892758,Imagery rescripting and eye movement desensitisation and reprocessing as treatment for adults with post-traumatic stress disorder from childhood trauma: randomised clinical trial.,"BACKGROUND


Investigation of treatments that effectively treat adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD) and are well tolerated by patients is needed to improve outcomes for this population.
AIMS


The purpose of this study was to compare the effectiveness of two trauma-focused treatments, imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR), for treating Ch-PTSD.
METHOD


We conducted an international, multicentre, randomised clinical trial, recruiting adults with Ch-PTSD from childhood trauma before 16 years of age. Participants were randomised to treatment condition and assessed by blind raters at multiple time points. Participants received up to 12 90-min sessions of either ImRs or EMDR, biweekly.
RESULTS


A total of 155 participants were included in the final intent-to-treat analysis. Drop-out rates were low, at 7.7%. A generalised linear mixed model of repeated measures showed that observer-rated post-traumatic stress disorder (PTSD) symptoms significantly decreased for both ImRs (d = 1.72) and EMDR (d = 1.73) at the 8-week post-treatment assessment. Similar results were seen with secondary outcome measures and self-reported PTSD symptoms. There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.
CONCLUSIONS


ImRs and EMDR treatments were found to be effective in treating PTSD symptoms arising from childhood trauma, and in reducing other symptoms such as depression, dissociation and trauma-related cognitions. The low drop-out rates suggest that the treatments were well tolerated by participants. The results from this study provide evidence for the use of trauma-focused treatments for Ch-PTSD.",2020,"There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.
","['A total of 155 participants were included in the final intent-to-treat analysis', 'adults with post-traumatic stress disorder from childhood trauma', 'adults with Ch-PTSD from childhood trauma before 16 years of age', 'adults with post-traumatic stress disorder from childhood experiences (Ch-PTSD']","['Imagery rescripting and eye movement desensitisation and reprocessing as treatment', 'imagery rescripting (ImRs) and eye movement desensitisation and reprocessing (EMDR', 'ImRs or EMDR, biweekly']","['self-reported PTSD symptoms', 'observer-rated post-traumatic stress disorder (PTSD) symptoms']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]",155.0,0.104754,"There were no significant differences between the two treatments on any standardised measure at post-treatment and follow-up.
","[{'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Boterhoven de Haan', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Australia.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fassbinder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Germany.'}, {'ForeName': 'Saskia M', 'Initials': 'SM', 'LastName': 'van Es', 'Affiliation': 'PsyQ Amsterdam, Parnassia Group, the Netherlands.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Menninga', 'Affiliation': 'PsyQ Beverwijk, Parnassia Group, the Netherlands.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Meewisse', 'Affiliation': 'Abate, Centre of Expertise in Anxiety and Psychotrauma, the Netherlands.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Rijkeboer', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, the Netherlands.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Kousemaker', 'Affiliation': 'Amstelveen, Sinai Centrum, the Netherlands.'}, {'ForeName': 'Arnoud', 'Initials': 'A', 'LastName': 'Arntz', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, the Netherlands.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.158']
2062,32893014,Attachment-retained removable prostheses: Patient satisfaction and quality of life assessment.,"STATEMENT OF PROBLEM


Studies on the impact of incorporating attachments in removable prostheses on patient-based outcomes are scarce.
PURPOSE


The purpose of this clinical study was to investigate oral health-related quality of life (OHRQoL) and patient satisfaction in partially edentulous participants before and after rehabilitation with mandibular attachment-retained removable prostheses as compared with conventional removable prostheses.
MATERIAL AND METHODS


This crossover study included 74 participants (aged 36 to 57). Initially, 56 received conventional clasp-retained removable dental prostheses (RDPs), and 18 received conventional overdentures (ODs) based on their mandibular partially edentulous state. Two months later, of the 56 RDP participants, 24 had received extracoronal attachment-retained RDPs, 17 received telescope-retained RDPs, and 15 received bar-attachment retained RDPs. The 18 OD participants received ball attachment-retained ODs. Assessments included Oral Health Impact Profile-short version-14 for OHRQoL and a visual analog scale (VAS) for patient satisfaction. Assessments were done before treatment and 2 months after wearing each prosthesis with a 1-month washout period. Statistical analysis included the Friedman then the Wilcoxon signed rank test for Oral Health Impact Profile-short version-14 scores and repeated measures ANOVA then the Bonferroni or paired t test for VAS scores (α=.05).
RESULTS


There were no dropouts. Rehabilitation, irrespective of prosthesis type, significantly improved OHRQoL in all domains and significantly increased overall patient satisfaction (P<.05). When compared with the conventional prostheses, attachment-retained prostheses significantly improved functional limitation, psychological discomfort, and physical limitation domains in all groups (P<.05), as well as the physical pain domain in the OD group (P=.041). General satisfaction, stability, comfort, ability to speak, and ability to masticate significantly increased (P<.05) with attachment-retained prostheses. Conventional prostheses were significantly easier to clean (P<.05) in all groups, except for the telescope-attachment group.
CONCLUSIONS


Both conventional and attachment-retained prostheses significantly increased patient satisfaction and improved OHRQoL in all domains as compared with before treatment. However, incorporation of attachments further improved functional limitation, psychological discomfort, and physical limitation domains in all groups, as well as the physical pain domain in the OD group. Participants were more satisfied with their attachment-retained prostheses in most aspects.",2020,"General satisfaction, stability, comfort, ability to speak, and ability to masticate significantly increased (P<.05) with attachment-retained prostheses.","['partially edentulous participants before and after rehabilitation with mandibular attachment-retained removable prostheses', '74 participants (aged 36 to 57']","['conventional removable prostheses', 'conventional clasp-retained removable dental prostheses (RDPs), and 18 received conventional overdentures (ODs) based on their mandibular partially edentulous state', 'ball attachment-retained ODs']","['Wilcoxon signed rank test for Oral Health Impact Profile-short version-14 scores', 'physical pain domain', 'oral health-related quality of life (OHRQoL) and patient satisfaction', 'satisfaction and quality of life assessment', 'Oral Health Impact Profile-short version-14\xa0for OHRQoL and a visual analog scale (VAS', 'OHRQoL', 'patient satisfaction and improved OHRQoL', 'overall patient satisfaction', 'General satisfaction, stability, comfort, ability to speak, and ability to masticate', 'functional limitation, psychological discomfort, and physical limitation domains']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0564214', 'cui_str': 'Ability to speak'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",74.0,0.0630425,"General satisfaction, stability, comfort, ability to speak, and ability to masticate significantly increased (P<.05) with attachment-retained prostheses.","[{'ForeName': 'Amal A', 'Initials': 'AA', 'LastName': 'Swelem', 'Affiliation': 'Professor, Oral and Maxillofacial Prosthodontic Department, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia; Removable Prosthodontic Department, Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt. Electronic address: amalswelem@hotmail.com.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Abdelnabi', 'Affiliation': 'Professor, Oral and Maxillofacial Prosthodontic Department, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia; Removable Prosthodontic Department, Faculty of Oral and Dental Medicine, Minia University, Minia, Egypt.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.07.006']
2063,32893023,Comparison of Connective Tissue Manipulation and Abdominal Massage Combined With Usual Care vs Usual Care Alone for Chronic Constipation: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the present study was to determine and compare the effects of connective tissue manipulation (CTM) and abdominal massage when combined with usual care on the symptoms of constipation and quality of life (QoL) immediately following a 4-week treatment in patients suffering from chronic constipation.
METHODS


A total of 60 patients with chronic constipation were randomly assigned to CTM, abdominal massage, or control groups. Connective tissue manipulation and abdominal massage were conducted at 5 sessions a week for 4 weeks. Each session was approximately 15 to 20 minutes. The severity of constipation by the Constipation Severity Instrument, symptoms of constipation by a bowel diary and Bristol Stool Scale, and QoL by patient assessment of QoL questionnaire were evaluated at baseline and at the end of 4 weeks.
RESULTS


There were significant differences in the changes in constipation severity (P < .001), symptoms of constipation (P ≤ .001), and QoL (P < .001) among the 3 groups. However, based on pair-wise analysis, there were no significant differences in the changes of the severity and symptoms of constipation and QoL between the CTM and abdominal massage groups (P > .05).
CONCLUSION


The findings of the present study revealed that compared to usual care alone, the combination of usual care and CTM or abdominal massage may be more beneficial for chronic constipation. However, the superiority of CTM or abdominal massage was not observed. Further high-quality studies with long-term follow-up are needed to investigate the optimal massage therapy program in patients with chronic constipation.",2020,"There were significant differences in the changes in constipation severity (P < .001), symptoms of constipation (P ≤ .001), and QoL (P < .001) among the 3 groups.","['60 patients with chronic constipation', 'Chronic Constipation', 'patients with chronic constipation', 'patients suffering from chronic constipation']","['Connective Tissue Manipulation and Abdominal Massage Combined With Usual Care vs Usual Care Alone', 'CTM', 'CTM, abdominal massage, or control groups', 'Connective tissue manipulation and abdominal massage', 'connective tissue manipulation (CTM) and abdominal massage']","['constipation severity', 'severity of constipation by the Constipation Severity Instrument, symptoms of constipation by a bowel diary and Bristol Stool Scale, and QoL by patient assessment of QoL questionnaire', 'constipation and quality of life (QoL', 'symptoms of constipation', 'QoL', 'severity and symptoms of constipation and QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}]","[{'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.031388,"There were significant differences in the changes in constipation severity (P < .001), symptoms of constipation (P ≤ .001), and QoL (P < .001) among the 3 groups.","[{'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Orhan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey. Electronic address: cerengursen@yahoo.com.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Özgül', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Baran', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Üzelpasacı', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Türkan', 'Initials': 'T', 'LastName': 'Akbayrak', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.05.013']
2064,32893024,"Effects of 4-Week Diacutaneous Fibrolysis on Myalgia, Mouth Opening, and Level of Functional Severity in Women With Temporomandibular Disorders: A Randomized Controlled Trial.","OBJECTIVE


The purpose of this study was to assess the effects of 4-week protocol of diacutaneous fibrolysis (DF) compared with simulated DF (sham-DF) on myalgia and mouth opening.
METHODS


In a sham randomized controlled trial, 34 women with temporomandibular disorders and myofascial pain were randomly divided as intervention group (IG) and sham-DF group (SG). The IG received 4 weeks of real DF, and the SG received sham. Pain was assessed through the visual analog scale and pressure pain thresholds (PPTs) on the temporomandibular joint (TMJ), and over the temporal and masseter muscles. The Mandibular Function Impairment Questionnaire was used to classify the participants regarding to the severity of the functional limitation related to TMD.
RESULTS


Pain scores decreased for both groups, but the IG showed lower values at week 4, with between-group differences. Bilateral temporal PPT showed higher values at week 4, with between-group differences. The SG had lower PPTs but the IG had higher PPTs, both compared to baseline results. The time-by-group interaction and the frequency of participants above 40 mm of mouth opening showed a significant difference for the IG over time with higher results at the 4-week assessment compared to its own baseline. Both groups showed lower MFIQ scores from baseline to 4-week assessment. There was a lower frequency of a moderate level of severity for the IG. No differences were observed for TMJ or for the masseter muscles PPT.
CONCLUSION


Improvements were observed for visual analog scale scores and PPTs on temporal muscles. There was a group-by-time interaction in the IG, suggesting a possible potential use of DF for mouth opening.",2020,"No differences were observed for TMJ or for the masseter muscles PPT.
","['Women With Temporomandibular Disorders', '34 women with temporomandibular disorders and myofascial pain']","['diacutaneous fibrolysis (DF', '4-Week Diacutaneous Fibrolysis', 'intervention group (IG) and sham-DF group (SG', 'TMJ', 'simulated DF (sham-DF']","['MFIQ scores', 'myalgia and mouth opening', 'Pain scores', 'visual analog scale and pressure pain thresholds (PPTs) on the temporomandibular joint (TMJ), and over the temporal and masseter muscles', 'visual analog scale scores and PPTs on temporal muscles', 'Myalgia, Mouth Opening, and Level of Functional Severity', 'Pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0024876', 'cui_str': 'Masseter muscle structure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",34.0,0.195285,"No differences were observed for TMJ or for the masseter muscles PPT.
","[{'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Leite', 'Affiliation': 'Musculoskeletal Research Group - NIME, Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil.'}, {'ForeName': 'Matheus L', 'Initials': 'ML', 'LastName': 'Oliveira', 'Affiliation': 'Musculoskeletal Research Group - NIME, Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil; Master Degree Program in Rehabilitation and Physical Performance, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil.'}, {'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Ferreira', 'Affiliation': 'Musculoskeletal Research Group - NIME, Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil.'}, {'ForeName': 'Carolina F', 'Initials': 'CF', 'LastName': 'Anjos', 'Affiliation': 'Musculoskeletal Research Group - NIME, Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil; Master Degree Program in Rehabilitation and Physical Performance, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Barbosa', 'Affiliation': 'Musculoskeletal Research Group - NIME, Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil; Master Degree Program in Rehabilitation and Physical Performance, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil.'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Barbosa', 'Affiliation': 'Musculoskeletal Research Group - NIME, Department of Physical Therapy, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil; Master Degree Program in Rehabilitation and Physical Performance, Federal University of Juiz de Fora, Governador Valadare, Minas Gerais, Brazil; Master Degree Program in Applied Health Sciences, Federal University of Juiz de Fora, Governador Valadares, Minas Gerais, Brazil. Electronic address: alexwbarbosa@hotmail.com.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.01.002']
2065,32893100,Comparative efficacy of the dorsal application of Kinesio tape and splinting for carpal tunnel syndrome: A randomized controlled trial.,"BACKGROUND


Carpal tunnel syndrome (CTS) symptoms are problematic especially when signs and symptoms are not substantial enough to require surgical intervention. Conservative treatments have mixed effectiveness, yet are one of the best options for mild to moderate CTS. Kinesio tape is an emerging modality, as it provides biomechanical support while allowing movement.
PURPOSE


The purpose of this study was to determine the efficacy of dorsal application of Kinesio tape on occupational performance as measured by pain and function in individuals with mild to moderate CTS, as compared with the accepted nonsurgical intervention of general cockup orthosis and lumbrical stretching exercises versus sham tape.
STUDY DESIGN


Single-blind randomized controlled trial.
METHODS


Forty-four participants (68 wrists) with CTS were randomized to one of three interventions: Kinesio tape group, sham group, or standard protocol group. Each completed baseline and four subsequent measurements of numeric pain rating scale, visual analog scale (VAS), Boston Carpal Tunnel Questionnaire (BCTQ), grip and pinch, with application of intervention every three days. Daily symptom journals were completed, standard protocol group recorded wearing schedule and exercises.
RESULTS


In the forearm and wrist, a significant reduction in median numeric pain rating scale pain scores in Kinesio tape group was observed (r = 0.76, P = .01; r = 0.77, P = .01; respectively), but not in the standard protocol group (r = 0.51, P = .17; r = 0.53, P = .11) and sham group (r = 0.46, P = .30; r = 0.39, P = .43) with a minimal clinically important difference of 1.0. In the Kinesio tape group, the forearm (24%) and wrist (36%) reached the clinical significance as compared with the standard protocol forearm (18%) and wrist (32%). The minimal clinically important difference for pain reduction on the visual analog scale was 1.64. Kinesio tape and sham group had significant improvement in function, but not the standard protocol group.
DISCUSSION


This study provides promising evidence for the use of Kinesio tape as a possible conservative intervention for management of symptoms in individuals with mild to moderate CTS. The study also illuminates new considerations of younger, active individuals reporting signs and symptoms of CTS as well as mechanism of effects on pain reduction.
CONCLUSIONS


Kinesio tape provided additional improvement in pain and function as compared to the standard approach.",2020,"In the forearm and wrist, a significant reduction in median numeric pain rating scale pain scores in Kinesio tape group was observed (r = 0.76, P = .01;","['individuals with mild to moderate CTS', 'Forty-four participants (68 wrists) with CTS', 'carpal tunnel syndrome']","['Kinesio tape', 'lumbrical stretching exercises versus sham tape', 'Kinesio tape and splinting', 'Kinesio tape group, sham group, or standard protocol group']","['visual analog scale', 'median numeric pain rating scale pain scores', 'pain and function', 'numeric pain rating scale, visual analog scale (VAS), Boston Carpal Tunnel Questionnaire (BCTQ), grip and pinch, with application of intervention every three days', 'function', 'pain reduction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0204861', 'cui_str': 'Application of splint'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1275551', 'cui_str': 'Every three days'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",44.0,0.068727,"In the forearm and wrist, a significant reduction in median numeric pain rating scale pain scores in Kinesio tape group was observed (r = 0.76, P = .01;","[{'ForeName': 'Donnamarie', 'Initials': 'D', 'LastName': 'Krause', 'Affiliation': 'Loma Linda University, Loma Linda, CA, USA. Electronic address: dckrause@llu.edu.'}, {'ForeName': 'Shawn C', 'Initials': 'SC', 'LastName': 'Roll', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA. Electronic address: sroll@chan.usc.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Javaherian-Dysinger', 'Affiliation': 'Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'Loma Linda University, Loma Linda, CA, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.010']
2066,32893128,Bowel management post major joint arthroplasty: A randomised controlled trial to test two pre-admission bowel regimens.,"BACKGROUND


The length of stay for patients undergoing joint arthroplasty has reduced but there is a paucity of knowledge relating to bowel management within this enhanced recovery framework.
AIM


The study's primary aim was to determine which of two dosage regimens of macrogol (Movicol®) commenced pre-operatively is most effective in facilitating a return to normal bowel function.
PROCEDURE


Ninety-one eligible patients were randomised to one of three groups: 1) commence macrogol one sachet in the morning for two days prior to surgery; 2) commence macrogol one sachet, morning and evening of the day prior to surgery; or 3) control group.
RESULTS


Seventy-seven percent of patients in group one, and 83% of group two had returned to normal bowel function by one-week post discharge compared to 70% of control patients (p = .470). Participants in group one required less aperients in the week following discharge compared with the other two groups although the result was not statistically significant (p = .060).
CONCLUSION


Despite not reaching statistical significance, the results are considered clinically significant. The authors recommend patients commence macrogol one sachet in the morning for the two days prior to admission for major joint arthroplasty and the Murdoch Bowel Protocol® continue to be followed for inpatients.",2020,"RESULTS


Seventy-seven percent of patients in group one, and 83% of group two had returned to normal bowel function by one-week post discharge compared to 70% of control patients (p = .470).","['Ninety-one eligible patients', 'patients undergoing joint arthroplasty', 'Bowel management post major joint arthroplasty']","['macrogol (Movicol®', 'commence macrogol one sachet in the morning for two days prior to surgery; 2) commence macrogol one sachet, morning and evening of the day prior to surgery; or 3) control group']",['normal bowel function'],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0150155', 'cui_str': 'Bowel care'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",91.0,0.0445121,"RESULTS


Seventy-seven percent of patients in group one, and 83% of group two had returned to normal bowel function by one-week post discharge compared to 70% of control patients (p = .470).","[{'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Ross-Adjie', 'Affiliation': 'School of Nursing and Midwifery, University of Notre Dame Fremantle, Australia. Electronic address: gail.ross-adjie1@nd.edu.au.'}, {'ForeName': 'Alexis A', 'Initials': 'AA', 'LastName': 'Cranfield', 'Affiliation': 'Clinical Nurse Research, Centre for Nursing and Midwifery Research, St John of God Murdoch Hospital, Murdoch, Australia.'}, {'ForeName': 'Piers J', 'Initials': 'PJ', 'LastName': 'Yates', 'Affiliation': 'Orthopaedic Surgery, University of Western Australia, Fremantle and Fiona Stanley Hospitals, Orthopaedics WA, St John of God Murdoch Private Hospital, Mount Hospital, St John of God Murdoch, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Monterosso', 'Affiliation': 'Centre for Nursing and Midwifery Research, St John of God Murdoch Hospital, Murdoch and University of Notre Dame Australia, Fremantle, Australia; School of Nursing and Midwifery, Edith Cowan University, Australia; Ngangk Yira Research Centre for Aboriginal Health and Social Equity, Murdoch University, Australia; College of Science, Health, Engineering and Education, Murdoch University, Australia.'}]",International journal of orthopaedic and trauma nursing,['10.1016/j.ijotn.2020.100816']
2067,32893136,Interprofessional Medication Assessment has Effects on the Quality of Medication Among Home Care Patients: Randomized Controlled Intervention Study.,"OBJECTIVE


Multimorbidity and complex medications increase the risk of medication-related problems, especially in vulnerable home care patients. The objective of this study was to examine whether interprofessional medication assessment has an effect on medication quality among home care patients.
DESIGN


The FIMA (Finnish Interprofessional Medication Assessment) study was a randomized, controlled study comparing physician-led interprofessional medication assessment and usual care.
SETTING AND PARTICIPANTS


The FIMA study was conducted in home care settings in Finland. The participants were ≥65-year-old home care patients with ≥6 drugs daily, dizziness, orthostatic hypotension, or a recent fall.
METHODS


Primary outcome measures over the 6-month follow-up were number of drugs, drug-drug-interactions, medication-related risk loads, and use of potentially inappropriate medications (PIMs) examined by SFINX, RENBASE, PHARAO, and Meds75+ databases. The databases classified information as follows: A (no known pharmacologic or clinical basis for an increased risk), B (evidence not available/uncertain), C (moderately increased risk which may have clinical relevance), and D (high risk, best to avoid). Logistic regression adjusted for age, sex, and the baseline level of the outcome measure served as statistical methods.
RESULTS


The mean number of all drugs for home care patients (n = 512) was 15. The odds of drug-induced impairment of renal function (RENBASE D, P = .020) and medication-related risk loads for bleeding (PHARAO D, P = .001), anticholinergic effects (PHARAO D, P = .009), and constipation (PHARAO D, P = .003) decreased significantly in the intervention group compared with usual care. The intervention also reduced the odds of using PIMs (Meds75+ D, P = .005). There were no significant changes in drug-drug-interactions or number of drugs.
CONCLUSIONS AND IMPLICATIONS


FIMA intervention improved the medication quality of home care patients. Risks for renal failure, anticholinergic effects, bleeding, constipation, and the use of PIMs were reduced significantly.",2020,"The intervention also reduced the odds of using PIMs (Meds75+ D, P = .005).","['participants were ≥65-year-old home care patients with ≥6 drugs daily, dizziness, orthostatic hypotension, or a recent fall', 'Home Care Patients', 'vulnerable home care patients', 'home care settings in Finland', 'home care patients']","['FIMA intervention', 'physician-led interprofessional medication assessment and usual care']","['renal function', 'renal failure, anticholinergic effects, bleeding, constipation, and the use of PIMs', '6-month follow-up were number of drugs, drug-drug-interactions, medication-related risk loads, and use of potentially inappropriate medications (PIMs) examined by SFINX, RENBASE, PHARAO, and Meds75+ databases', 'medication quality', 'anticholinergic effects', 'drug-drug-interactions or number of drugs', 'constipation']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0020651', 'cui_str': 'Orthostatic hypotension'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0256847,"The intervention also reduced the odds of using PIMs (Meds75+ D, P = .005).","[{'ForeName': 'Kati J', 'Initials': 'KJ', 'LastName': 'Auvinen', 'Affiliation': 'The East Savo Hospital District, Savonlinna, Finland; Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland. Electronic address: kati.auvinen@sosteri.fi.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Räisänen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Voutilainen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Jyrkkä', 'Affiliation': 'Assessment of Pharmacotherapies, Finnish Medicines Agency, Kuopio, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Mäntyselkä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland; Kuopio University Hospital, Primary Health Care Unit, Kuopio, Finland.'}, {'ForeName': 'Eija', 'Initials': 'E', 'LastName': 'Lönnroos', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.07.007']
2068,32893151,A comparison of patient-reported outcomes between Alloderm and Dermacell in immediate alloplastic breast reconstruction: A randomized control trial.,"BACKGROUND


Alloderm and Dermacell are the two leading human acellular dermal matrices (ADM) in immediate breast reconstruction (IBR). Despite differences in sterility, consistency, thickness and cost, there are no comparative trials to date to compare patient-reported outcome measures (PROM) between the two products. The purpose of this study was to determine if there was a difference in patient-reported outcomes (as measured by the BREAST-Q) between patients reconstructed with Alloderm and Dermacell.
METHODS


A single center, open-label, randomized control trial of patients undergoing IBR with an implant for breast cancer or breast cancer prophylaxis was performed. Patients were randomized to either Alloderm or Dermacell. Baseline demographic data were compared, and linear mixed models were used to identify associations with BREAST-Q over time.
RESULTS


Between June 2016 and October 2018, 62 patients were randomized into two groups, 31(50%) Alloderm and 31(50%) Dermacell. Of these, 23(74%) patients in the Alloderm group and 27(87%) patients of the Dermacell group filled out BREAST-Q questionnaires. Baseline BREAST-Q scores with respect to satisfaction with breasts, psychosocial well-being, sexual well-being, and physical well-being were similar between groups (p>0.05). At 3 months postoperatively, the Alloderm group had a statistically significant improvement with respect to satisfaction with breasts (67 vs 53, p = 0.03), satisfaction with overall results (85 vs 61, p = 0.003), satisfaction with the surgeon (89 vs 67, p = 0.01), and satisfaction with information provided (74 vs 59, p = 0.02). At 12 months postoperatively, there were no statistically significant differences in PROM between groups (p>0.05).
CONCLUSION


We report the first randomized controlled trial to date comparing patient-reported outcomes of the two most commonly used ADMs in IBR in Canada. Although a short-term analysis favors the use of Alloderm, there does not appear to be any difference in outcomes between the two products in the longer term.",2020,"At 12 months postoperatively, there were no statistically significant differences in PROM between groups (p>0.05).
","['Between June 2016 and October 2018, 62 patients were randomized into two groups, 31(50%) Alloderm and 31(50', 'patients undergoing IBR with an implant for breast cancer or breast cancer prophylaxis was performed']",['Alloderm or Dermacell'],"['satisfaction with the surgeon', 'satisfaction with breasts', 'sterility, consistency, thickness and cost', 'PROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1099479', 'cui_str': 'Alloderm'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1099479', 'cui_str': 'Alloderm'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}]",62.0,0.0900616,"At 12 months postoperatively, there were no statistically significant differences in PROM between groups (p>0.05).
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stein', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Arnaout', 'Affiliation': 'Division of General Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Julia B', 'Initials': 'JB', 'LastName': 'Lichtenstein', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Frank', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cordeiro', 'Affiliation': 'Division of General Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Division of General Surgery, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Ghaedi', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Ottawa, Ottawa, Canada. Electronic address: jzhang1@toh.ca.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.08.018']
2069,32893155,Improving Academic Performance in Medical Students Using Immersive Virtual Patient Simulation: A Randomized Controlled Trial.,"OBJECTIVES


To determine whether immersive virtual patient simulation (IVPS) on the MedicActiv platform is influential in improving student academic performance in module validation tests.
DESIGN


In this prospective randomized controlled study a comparison was made between IVPS training combined with regular faculty courses versus courses alone. The primary endpoint was module validation grades. Secondary endpoints were satisfaction scores (overall interest, ergonomics, realism, immersion, and training efficiency).
SETTING


Angers School of Medicine, France.
PARTICIPANTS


2018 to 2019 class of fourth-year students, included on a voluntary basis. In the first semester 51 students were included, of whom 13 were excluded for lack of compliance (6 and 7 from the IVPS and control groups, respectively). In the second semester we included 57 students, of whom 10 were excluded for lack of compliance (2 and 8 from the IVPS and control groups, respectively).
RESULTS


Mean age was 21 years (±0.8). There were 85 female and 23 male students. In the first semester mean grades were 13.4 ± 1.6 versus 11/.9 ± 2.4 in the IVPS and control groups, respectively (p = 0.038). In the second semester mean grades were 15.3 ± 2.5 versus 11.9 ± 3.6 in the IVPS and control groups, respectively p < 0.001. The entire study population was pooled (n = 85): mean grades were 14.5 ± 2.4 versus 11.9 ± 3 in the IVPS group and the control group, respectively, p < 0.001. The satisfaction questionnaire response rate was 54% (46/85). Score percentages ≥4 regarding overall interest, ergonomics, realism, immersion and training efficiency were 89%, 85%, 100%, 93%, and 93% respectively.
CONCLUSIONS


Complementing conventional university education with simulation of virtual consultation cases on the MedicActiv platform improved student academic performance as compared with students studying regular courses. Students reported high levels of satisfaction with overall interest, ergonomics, realism, immersion and training efficiency on the MedicActiv platform.",2020,"Students reported high levels of satisfaction with overall interest, ergonomics, realism, immersion and training efficiency on the MedicActiv platform.","['2018 to 2019 class of fourth-year students, included on a voluntary basis', 'Angers School of Medicine, France', '85 female and 23 male students', 'In the first semester 51 students were included, of whom 13 were excluded for lack of compliance (6 and 7 from the IVPS and control groups, respectively', 'Medical Students Using Immersive Virtual Patient Simulation', '57 students, of whom 10 were excluded for lack of compliance (2 and 8 from the IVPS and control groups, respectively']","['IVPS training combined with regular faculty courses versus courses alone', 'immersive virtual patient simulation (IVPS']","['satisfaction scores (overall interest, ergonomics, realism, immersion, and training efficiency', 'levels of satisfaction with overall interest, ergonomics, realism, immersion and training efficiency on the MedicActiv platform', 'student academic performance', 'overall interest, ergonomics, realism, immersion and training efficiency', 'satisfaction questionnaire response rate']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0303135', 'cui_str': 'Beryllium-10'}]","[{'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",51.0,0.0458205,"Students reported high levels of satisfaction with overall interest, ergonomics, realism, immersion and training efficiency on the MedicActiv platform.","[{'ForeName': 'Souhil', 'Initials': 'S', 'LastName': 'Lebdai', 'Affiliation': 'Urology Department, University Hospital of Angers, Angers, France; AllSims Center for Simulation in Healthcare, University Hospital of Angers, Angers, France. Electronic address: souhil.lebdai@gmail.com.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mauget', 'Affiliation': 'AllSims Center for Simulation in Healthcare, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Cousseau', 'Affiliation': 'AllSims Center for Simulation in Healthcare, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Jean Claude', 'Initials': 'JC', 'LastName': 'Granry', 'Affiliation': 'AllSims Center for Simulation in Healthcare, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'AllSims Center for Simulation in Healthcare, University Hospital of Angers, Angers, France.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.08.031']
2070,32893211,[Effect of collagen peptides on skeletal muscle mass in the elderly: An interventional study examining oral nutrition support for patients in a recovery-phase rehabilitation ward].,"AIM


The present study aimed to compare the effect of collagen peptides on skeletal muscle mass between patients in a recovery-phase rehabilitation ward who received oral nutrition support intervention with collagen peptides (intervention group) and those who did not (control group).
METHODS


Subjects were 19 patients ≥65 years old who had been admitted to our recovery-phase rehabilitation ward due to fracture or stroke between June 1 and August 31, 2018. The intervention group received an oral nutrition supplement containing 10 g of collagen peptides.
RESULTS


The mean age was 78.3±7.0 years old in the intervention group (3 men and 7 women), and 75.2±5.5 years old in the control group (2 men and 7 women). The fat-free mass, skeletal muscle mass, and skeletal muscle mass indices per body surface area increased by 0.55±1.4 kg/m 2 , 0.29±0.8 kg/m 2 , and 0.11±0.3 kg/m 2 , respectively, in the intervention group, and decreased by 1.67±2.2 kg/m 2 , 0.96±1.3 kg/m 2 , and 0.31±0.4 kg/m 2 , respectively, in the control group. The intervention group had significantly higher fat-free mass, skeletal muscle mass, and skeletal muscle mass indices than the control group. The daily skeletal muscle mass index (calculated by dividing the skeletal muscle mass index by the days of hospitalization) in the intervention group was 0.002±0.03 kg.
CONCLUSIONS


Our results suggest that the oral intake of collagen peptides increases the skeletal muscle mass in patients in recovery-phase rehabilitation wards.",2020,"The intervention group had significantly higher fat-free mass, skeletal muscle mass, and skeletal muscle mass indices than the control group.","['the elderly', 'patients in a recovery-phase rehabilitation ward who received', 'Subjects were 19 patients ≥65 years old who had been admitted to our recovery-phase rehabilitation ward due to fracture or stroke between June 1 and August 31, 2018', 'The mean age was 78.3±7.0 years old in the intervention group (3 men and 7 women), and 75.2±5.5 years old in the control group (2 men and 7 women', 'patients in a recovery-phase rehabilitation ward', 'patients in recovery-phase rehabilitation wards']","['oral nutrition supplement containing 10 g of collagen peptides', 'oral nutrition support intervention with collagen peptides (intervention group) and those who did not (control group', 'collagen peptides']","['skeletal muscle mass', 'higher fat-free mass, skeletal muscle mass, and skeletal muscle mass indices', 'daily skeletal muscle mass index', 'fat-free mass, skeletal muscle mass, and skeletal muscle mass indices per body surface area']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0386744', 'cui_str': 'AM 19'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}]",,0.0261427,"The intervention group had significantly higher fat-free mass, skeletal muscle mass, and skeletal muscle mass indices than the control group.","[{'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Baba', 'Affiliation': 'Zenjokai Rehabilitation Hospital.'}, {'ForeName': 'Eiko', 'Initials': 'E', 'LastName': 'Suzaki', 'Affiliation': 'Zenjokai Rehabilitation Hospital.'}, {'ForeName': 'Kozue', 'Initials': 'K', 'LastName': 'Taira', 'Affiliation': 'Zenjokai Rehabilitation Hospital.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Zenjokai Rehabilitation Hospital.'}, {'ForeName': 'Hikari', 'Initials': 'H', 'LastName': 'Kachi', 'Affiliation': 'Zenjokai Rehabilitation Hospital.'}, {'ForeName': 'Atushi', 'Initials': 'A', 'LastName': 'Okada', 'Affiliation': 'Zenjokai Rehabilitation Hospital.'}]",Nihon Ronen Igakkai zasshi. Japanese journal of geriatrics,['10.3143/geriatrics.57.291']
2071,32893274,"The effect of laryngoscope types on hemodynamic response and optic nerve sheath diameter. McCoy, Macintosh, and C-MAC video-laryngoscope.","OBJECTIVES


This study aims to investigate the effect of McCoy, Macintosh laryngoscope, and C-MAC video-laryngoscopes on optic nerve sheath diameter (ONSD) and hemodynamic responses to laryngoscopy and intubation.
METHODS


This prospective randomized study was conducted in Zonguldak Bülent Ecevit University Hospital, Zonguldak, Turkey, between July 2019 and January 2020. Informed written consent was obtained from all patients. Patients with previous intracranial/ocular surgery or glaucoma were excluded from the study. The patients were randomized to use McCoy, Macintosh, and C-MAC (30 per group). Intubations were performed by the same person. Mean arterial pressure, heart rate (HR), and ONSD were recorded before the induction and repeated in 1, 3, 5, and 10 minutes after the intubation.
RESULTS


The effects of laryngoscopy and intubation on hemodynamic responses and ONSD were similar between groups (p greater than 0.05). While the comparison within groups showed ONSD increase in McCoy group and HR and ONSD increase in the Macintosh group compared to baseline 1 min after the intubation, no change was observed in hemodynamic responses and ONSD measurements in the C-MAC® group (p greater than 0.05).
CONCLUSIONS


In this study, there was no significant difference between the groups in terms of ONSD and hemodynamic responses to laryngoscopy and intubation. It was observed that there were no significant changes in ONSD values just in C-MAC® video-laryngoscope group. Therefore, intubations with C-MAC® video-laryngoscope are thought to be more appropriate for patients with an increase in intracranial pressure.",2020,It was observed that there were no significant changes in ONSD values just in C-MAC® video-laryngoscope group.,"['Zonguldak Bülent Ecevit University Hospital, Zonguldak, Turkey, between July 2019 and January 2020', 'Patients with previous intracranial/ocular surgery or glaucoma were excluded from the study']","['McCoy, Macintosh, and C-MAC', 'laryngoscopy and intubation', 'McCoy, Macintosh laryngoscope, and C-MAC video-laryngoscopes']","['ONSD values', 'ONSD and hemodynamic responses', 'Mean arterial pressure, heart rate (HR), and ONSD', 'hemodynamic responses and ONSD', 'ONSD increase in McCoy group and HR and ONSD increase', 'hemodynamic response and optic nerve sheath diameter', 'hemodynamic responses and ONSD measurements', 'intracranial pressure']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}]",,0.0287892,It was observed that there were no significant changes in ONSD values just in C-MAC® video-laryngoscope group.,"[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Küçükosman', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Bülent Ecevit University, Zonguldak, Turkey. E-mail. gamzebeu@gmail.com.'}, {'ForeName': 'Bengü G', 'Initials': 'BG', 'LastName': 'Aydın', 'Affiliation': ''}, {'ForeName': 'Necla', 'Initials': 'N', 'LastName': 'Gülçek', 'Affiliation': ''}, {'ForeName': 'Rahşan D', 'Initials': 'RD', 'LastName': 'Okyay', 'Affiliation': ''}, {'ForeName': 'Özcan', 'Initials': 'Ö', 'LastName': 'Pişkin', 'Affiliation': ''}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Ayoğlu', 'Affiliation': ''}]",Saudi medical journal,['10.15537/smj.2020.9.25349']
2072,32893313,Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.,"PURPOSE


We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF).
METHODS


We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for ≤ 5 days expected to require MV for ≥ 72 h and able to breathe spontaneously were eligible for enrollment. Eligible patients were randomly assigned based on balanced treatment assignments with a computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group). Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days (VFDs) at 28 days. Secondary outcome was all-cause hospital mortality. All analyses were done according to the intention-to-treat principle.
RESULTS


Between March 2014 and October 2019, we enrolled 306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group. Median VFDs were higher in the NAVA than in the control group (22 vs. 18 days; between-group difference 4 days; 95% confidence interval [CI] 0 to 8 days; p = 0.016). At hospital discharge, 39 (25.5%) patients in the NAVA group and 47 (30.7%) patients in the control group had died (between-group difference - 5.2%, 95% CI - 15.2 to 4.8, p = 0.31). Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
CONCLUSION


NAVA decreased duration of MV although it did not improve survival in ventilated patients with ARF.",2020,"Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
","['patients with ARF from several etiologies', 'Eligible patients', '306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group', 'acute respiratory failure', 'patients with acute respiratory failure (ARF', 'ventilated patients with ARF', 'Intubated patients ventilated for\u2009≤\u20095\xa0days expected to require MV for\u2009≥\u200972\xa0h and able to breathe spontaneously were eligible for enrollment', 'Between March 2014 and October 2019']","['conventional lung-protective mechanical ventilation (MV', 'neurally adjusted ventilatory assist (NAVA', 'NAVA', 'Neurally adjusted ventilatory assist', 'computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group']","['MV and mortality', 'number of ventilator-free days (VFDs', 'duration of MV', 'cause hospital mortality', 'died', 'Median VFDs', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0566270', 'cui_str': 'Able to breathe'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",306.0,0.274373,"Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kacmarek', 'Affiliation': 'Department of Respiratory Care, Massachusetts General Hospital, 55 Fruit St, Warren 1225, Boston, MA, 01460, USA. rkacmarek@partners.org.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. jesus.villar54@gmail.com.'}, {'ForeName': 'Dácil', 'Initials': 'D', 'LastName': 'Parrilla', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alba', 'Affiliation': 'Intensive Care Unit, Hospital N.S. del Prado, Talavera de La Reina, Toledo, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Solano', 'Affiliation': 'Intensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Intensive Care Unit, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Montiel', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rico-Feijoo', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Anxela', 'Initials': 'A', 'LastName': 'Vidal', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Murcia', 'Affiliation': 'Intensive Care Unit, Complejo Universitario de Albacete, Albacete, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Corpas', 'Affiliation': 'Intensive Care Unit, Hospital N.S. del Prado, Talavera de La Reina, Toledo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'González-Higueras', 'Affiliation': 'Intensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Intensive Care Unit, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'César E', 'Initials': 'CE', 'LastName': 'Pinedo', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pestaña', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Ramón Y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Virgen de Arrixaca, Murcia, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Aldecoa', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Añón', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Soro', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jesús M', 'Initials': 'JM', 'LastName': 'González-Martín', 'Affiliation': 'Biostatistics Division, Research Unit, Universitario Dr. Negrín, Las Palmas, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernández', 'Affiliation': 'Research Unit, Hospital Universitario Dr. Negrín, Barranco de la Ballena s/n, 4th Floor South Wing, 35019, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Rosa L', 'Initials': 'RL', 'LastName': 'Fernández', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06181-5']
2073,32893322,One versus two anterior miniscrews for correcting upper incisor overbite and angulation: a retrospective comparative study.,"BACKGROUND


Miniscrews are effective devices for performing upper incisor intrusion. Different mechanics can be applied depending on the treatment objectives. This study aimed to evaluate the efficacy of one or two anterior miniscrews for upper incisor correction in cases of overbite and angulation in adult patients.
METHODS


Forty-four adults with deep overbite were divided into two groups: group 1 was treated with one miniscrew between upper central incisors and group 2 with two miniscrews between upper lateral incisors and canines. Incisor intrusion and length were measured from lateral cephalograms before treatment, after treatment and at least 12 months into retention (T0, T1 and T2). Forces were applied (90 g) from the miniscrews to the archwire using elastomeric chains. ANOVA analysis was used to determine whether differences between evaluation times were statistically significant.
RESULTS


Mean root resorption was 2.15 ± 0.85 mm, which ceased after active treatment. Overbite mean correction was - 3.23 ± 1.73 mm with no statistically significant relapse. Overbite correction and incisor intrusion were significantly greater in group 2 (- 3.80 ± 1.43 versus - 2.75 ± 1.63 for OB and 8.19 ± 3.66 versus 5.69 ± 2.66 for intrusion). Resorption and overbite correction were positively related. No counterclockwise rotation of the mandibular plane was observed.
CONCLUSIONS


Overbite correction can be performed by means of upper incisor intrusion without rotation of the mandibular plane. Correction of upper incisor intrusion and overbite is greater in patients treated with two miniscrews. The increase in upper incisor buccal angulation is greater with one miniscrew. Root resorption is positively related to the extent of intrusion. Stability is satisfactory regardless of whether one or two miniscrews are used.",2020,Overbite correction and incisor intrusion were significantly greater in group 2 (- 3.80 ± 1.43 versus - 2.75 ± 1.63 for OB and 8.19 ± 3.66 versus 5.69 ± 2.66 for intrusion).,"['Forty-four adults with deep overbite', 'cases of overbite and angulation in adult patients']",['one miniscrew between upper central incisors and group 2 with two miniscrews between upper lateral incisors and canines'],"['Root resorption', 'Resorption and overbite correction', 'Incisor intrusion and length', 'upper incisor buccal angulation', 'Overbite correction and incisor intrusion', 'Mean root resorption']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0266063', 'cui_str': 'Deep overbite'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0227040', 'cui_str': 'Structure of maxillary right lateral incisor tooth'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",44.0,0.0191748,Overbite correction and incisor intrusion were significantly greater in group 2 (- 3.80 ± 1.43 versus - 2.75 ± 1.63 for OB and 8.19 ± 3.66 versus 5.69 ± 2.66 for intrusion).,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Vela-Hernández', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gutiérrez-Zubeldia', 'Affiliation': 'In private practice, Vitoria, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'López-García', 'Affiliation': 'In private practice, Vitoria, Spain.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'García-Sanz', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Paredes-Gallardo', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain. Vanessa.paredes@uv.es.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Gandía-Franco', 'Affiliation': 'Orthodontics Teaching Unit, Department of Stomatology, University of Valencia, Gascó Oliag 1, 46010, Valencia, Spain.'}, {'ForeName': 'Felicidad', 'Initials': 'F', 'LastName': 'Lasagabaster-Latorre', 'Affiliation': 'In private practice, Vitoria, Spain.'}]",Progress in orthodontics,['10.1186/s40510-020-00336-2']
2074,32893328,"Effects of fingolimod, a sphingosine-1-phosphate (S1P) receptor agonist, on white matter microstructure, cognition and symptoms in schizophrenia.","Several lines of evidence have implicated white matter (WM) deficits in schizophrenia, including microstructural alterations from diffusion tensor (DTI) brain imaging studies. It has been proposed that dysregulated inflammatory processes, including heightened activity of circulating lymphocytes, may contribute to WM pathology in this illness. Fingolimod is a sphingosine-1-phosphate (S1P) receptor agonist that is approved for the treatment of relapsing multiple sclerosis (MS). Fingolimod robustly decreases the number of circulating lymphocytes through sequestration of these cells in lymph tissue. In addition, this agent improved WM microstructure as shown by increases in DTI fractional anisotropy (FA). In this pilot study, we assessed the effects of fingolimod on WM microstructure, cognition and symptoms in an eight-week, double-blind trial. Forty subjects with schizophrenia or schizoaffective disorder were randomized 1:1 to fingolimod (0.5 mg/day) and placebo. Fingolimod caused significant reductions in circulating lymphocytes (p < .001). In addition, there was a statistically non-significant association (p = .089) between DTI-FA change in the WM skeleton and fingolimod. There were significant relationships between the degree of lymphocyte reductions and increases in FA in the corpus collosum (p = .004) and right superior longitudinal fasciculus ( p = .02), and a non-significant correlation with the WM skeleton. There were no significant fingolimod versus placebo interactions on cognitive or symptom measures. There were no serious adverse events related to fingolimod treatment. Future studies with larger samples and treatment durations are needed to further establish fingolimod's potential therapeutic effects in schizophrenia.",2020,Fingolimod caused significant reductions in circulating lymphocytes (p < .001).,['Forty subjects with schizophrenia or schizoaffective disorder'],"['placebo', 'fingolimod, a sphingosine-1-phosphate (S1P) receptor agonist', 'fingolimod']","['FA', 'degree of lymphocyte reductions', 'DTI fractional anisotropy (FA', 'cognitive or symptom measures', 'circulating lymphocytes', 'WM microstructure, cognition and symptoms', 'right superior longitudinal fasciculus', 'serious adverse events']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0228270', 'cui_str': 'Structure of superior longitudinal fasciculus'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.0315387,Fingolimod caused significant reductions in circulating lymphocytes (p < .001).,"[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Francis', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA. mmfranci@iupui.edu.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Hummer', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Liffick', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Jenifer L', 'Initials': 'JL', 'LastName': 'Vohs', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Nikki F', 'Initials': 'NF', 'LastName': 'Mehdiyoun', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Visco', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University, 410 W. Tenth St., Suite 3000, 46202, Indianapolis, IN, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kovacs', 'Affiliation': 'Krannert Institute of Cardiology, Indiana University School of Medicine, 1801 N. Senate Blvd, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Richard M. Fairbanks School of Public Health, Indiana University, 410 W. Tenth St., Suite 3000, 46202, Indianapolis, IN, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Breier', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, 355 W. 16th St., Suite 4800, Indianapolis, IN, 46202, USA.'}]",Brain imaging and behavior,['10.1007/s11682-020-00375-7']
2075,32893384,"Protective effect of supplementation with Ginseng, Lilii Bulbus and Poria against PM 2   .5  in air pollution-induced cardiopulmonary damage among adults.","Exposure to PM 2.5  (particulate matter with an aerodynamic diameter ≤ 2.5 μm) has been associated with increased cardiopulmonary outcomes, mediated by a hypothesized biological mechanism of systemic inflammation and oxidation. This randomized, double-blinded and placebo-controlled trial among 120 healthy adults in Wuhan, China, was conducted to evaluate whether the supplementation of herbal product composed of Ginseng, Lilii Bulbus and Poria (GLP) which have been shown to have anti-inflammatory and anti-oxidant activity offers protective effects on PM 2.5  -induced damage to cardiopulmonary health. Participants received four rounds of health examinations and two rounds of blood sample collection from November 2018 to January 2019. Compared to the placebo group, the GLP group showed significant increased antioxidant biomarkers such as superoxide dismutase (SOD) and paraoxonase1 (PON1). What is more, interleukin-6 (IL-6), an inflammatory biomarker, was significantly decreased in the GLP group. In addition, nitric oxide and club cell secretory protein (CC16) were increased but heart rate was decreased in the GLP group. As for pulmonary function indicators, significantly increased fractional exhaled nitric oxide (FeNO) was observed in the GLP group. Taken together, we concluded that GLP supplementation is associated with decreased inflammatory biomarker and increased antioxidant biomarkers suggesting cardiopulmonary benefits against PM 2.5  exposure among young adults in China.",2020,"Compared to the placebo group, the GLP group showed significant increased antioxidant biomarkers such as superoxide dismutase (SOD) and paraoxonase1 (PON1).","['air pollution-induced cardiopulmonary damage among adults', 'Participants received four rounds of health examinations and two rounds of blood sample collection from November 2018 to January 2019', '120 healthy adults in Wuhan, China', 'young adults in China']","['GLP', 'herbal product composed of Ginseng, Lilii Bulbus and Poria (GLP', 'GLP supplementation', 'placebo', 'supplementation with Ginseng, Lilii Bulbus and Poria against PM']","['nitric oxide and club cell secretory protein (CC16', 'fractional exhaled nitric oxide (FeNO', 'antioxidant biomarkers such as superoxide dismutase (SOD) and paraoxonase1 (PON1', 'heart rate']","[{'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C1034607', 'cui_str': 'Poria'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0225668', 'cui_str': 'Clara cell of bronchiole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",120.0,0.186547,"Compared to the placebo group, the GLP group showed significant increased antioxidant biomarkers such as superoxide dismutase (SOD) and paraoxonase1 (PON1).","[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': ""Key Laboratory of Environment and Health, Ministry of Education and Ministry of Environmental Protection, and State Key Laboratory of Environmental Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Nutrilite Health Institute, Amway (Lin et al.) R&D Center, Shanghai, China.'}, {'ForeName': 'Hanjin', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Key Laboratory of Environment and Health, Ministry of Education and Ministry of Environmental Protection, and State Key Laboratory of Environmental Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""Key Laboratory of Environment and Health, Ministry of Education and Ministry of Environmental Protection, and State Key Laboratory of Environmental Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Xiaojie', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Key Laboratory of Environment and Health, Ministry of Education and Ministry of Environmental Protection, and State Key Laboratory of Environmental Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Juntao', 'Initials': 'J', 'LastName': 'Kan', 'Affiliation': 'Nutrilite Health Institute, Amway (Lin et al.) R&D Center, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Nutrilite Health Institute, Amway (Lin et al.) R&D Center, Shanghai, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Key Laboratory of Environment and Health, Ministry of Education and Ministry of Environmental Protection, and State Key Laboratory of Environmental Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}]",Phytotherapy research : PTR,['10.1002/ptr.6835']
2076,32893505,Mechanisms of Diuretic Resistance Study: design and rationale.,"INTRODUCTION


Diuretic resistance is a common complication impairing decongestion during hospitalization for acute decompensated heart failure (ADHF). The current understanding of diuretic resistance mechanisms in ADHF is based upon extrapolations from other disease states and healthy volunteers. However, accumulating evidence suggests that the dominant mechanisms in other populations have limited influence on diuretic response in ADHF. Additionally, the ability to rapidly and reliably diagnose diuretic resistance is inadequate using currently available tools.
AIMS


The Mechanisms of Diuretic Resistance (MDR) Study is designed to rigorously investigate the mechanisms of diuretic resistance and develop tools to rapidly predict diuretic response in a prospective cohort hospitalized with ADHF.
METHODS


Study assessments occur serially during the ADHF hospitalization and after discharge. Each assessment includes a supervised 6-hour urine collection with baseline blood and timed spot urine collections following loop diuretic administration. Patient characteristics, medications, physical exam findings, and both in-hospital and post-discharge HF outcomes are collected. Patients with diuretic resistance are eligible for a randomized sub-study comparing an increased loop diuretic dose with combination diuretic therapy of loop diuretic plus chlorothiazide.
CONCLUSIONS


The Mechanisms of Diuretic Resistance Study will establish a prospective patient cohort and biorepository to investigate the mechanisms of diuretic resistance and urine biomarkers to rapidly predict loop diuretic resistance.",2020,"INTRODUCTION


Diuretic resistance is a common complication impairing decongestion during hospitalization for acute decompensated heart failure (ADHF).","['acute decompensated heart failure (ADHF', 'Patients with diuretic resistance', 'healthy volunteers']",['combination diuretic therapy of loop diuretic plus chlorothiazide'],"['Patient characteristics, medications, physical exam findings, and both in-hospital and post-discharge HF outcomes', 'diuretic response']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008273', 'cui_str': 'Chlorothiazide'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}]",,0.0288931,"INTRODUCTION


Diuretic resistance is a common complication impairing decongestion during hospitalization for acute decompensated heart failure (ADHF).","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ivey-Miranda', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mahoney', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Keyanna', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Daniel Z', 'Initials': 'DZ', 'LastName': 'Hodson', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gomez', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Veena S', 'Initials': 'VS', 'LastName': 'Rao', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Testani', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}]",ESC heart failure,['10.1002/ehf2.12949']
2077,32893512,Randomized Controlled Trial Protocol for Evaluating the Effect of Group Education on Postmenopausal Sexual Dysfunction.,"OBJECTIVES


This study primarily aimed to determine the effect of group education on sexual dysfunction in postmenopausal women referred to health centers in Hamadan, Iran.
METHODS


This randomized controlled clinical trial conducted on 90 postmenopausal women from October 2018 to March 2019. Postmenopausal women who met the inclusion criteria and received approval of a psychiatrist were randomly divided into intervention and control groups (n = 45 in each group). They completed the demographic questionnaire and the Female Sexual Function Index questionnaire. Thereafter, four sessions of group training were conducted for women in the intervention group; these women were followed up for 1 month after the last training session. Data were analyzed using the SPSS ver. 16 software, and descriptive statistics and ANCOVA/ANOVA test were used for data analysis.
RESULTS


We found that the two groups were homogenous in most of the demographic variables and the data were normal. The total mean score of sexual function and standard deviation after the intervention was 23.70 ± 3.67 in the intervention group and 19.94 ± 3.64 in the control group, indicating that these scores were significantly higher in the intervention group than in the control group ( P  < 0.001).
CONCLUSIONS


Based on the results, group training is recommended to reduce sexual dysfunction in postmenopausal women at health centers.",2020,"The total mean score of sexual function and standard deviation after the intervention was 23.70 ± 3.67 in the intervention group and 19.94 ± 3.64 in the control group, indicating that these scores were significantly higher in the intervention group than in the control group ( P  < 0.001).
","['90 postmenopausal women from October 2018 to March 2019', 'postmenopausal women referred to health centers in Hamadan, Iran', 'Postmenopausal women who met the inclusion criteria and received approval of a psychiatrist', 'postmenopausal women at health centers']",['Group Education'],"['Postmenopausal Sexual Dysfunction', 'demographic questionnaire and the Female Sexual Function Index questionnaire', 'total mean score of sexual function and standard deviation', 'sexual dysfunction']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}]","[{'cui': 'C0150375', 'cui_str': 'Group education'}]","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",90.0,0.0357161,"The total mean score of sexual function and standard deviation after the intervention was 23.70 ± 3.67 in the intervention group and 19.94 ± 3.64 in the control group, indicating that these scores were significantly higher in the intervention group than in the control group ( P  < 0.001).
","[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Alavipour', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Masoumi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Parsa', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of menopausal medicine,['10.6118/jmm.19020']
2078,32893515,Effect of Combined Herbal Capsule Menohelp on Hot Flashes and Night Sweats in Postmenopausal Women: A Single-Blind Randomized Controlled Trial.,"OBJECTIVES


Hot flashes and night sweats are the most common and annoying consequences of menopause. The present study aimed to investigate the effect of a combined herbal capsule (black cohosh, soy, potato, chaste tree, and burdock) on hot flashes and night sweats in postmenopausal women.
METHODS


The present study was a randomized clinical trial conducted on postmenopausal women who were referred to Hamadan health centers in 2018-2019. The patients were distributed randomly in two groups of 85 individuals using the permuted block technique. The intervention group received the Menohelp capsule 550 mg twice daily for eight weeks and those in the control group received placebo. Data was obtained using a demographic questionnaire and a night sweat checklist one week before and eight weeks after the intervention. Data analysis was done using Stata 13.
RESULTS


Data analysis revealed that means of hot flashes duration, frequency and intensity did not significantly decrease in the postintervention phase as compared to the pre-intervention phase in both the groups ( P  > 0.05). Comparative analyses of frequency and intensity of night sweats in the two groups revealed that both variables decreased after intervention with the Menohelp capsule ( P  < 0.05).
CONCLUSIONS


This study revealed that combined herbal medicine (Menohelp) was effective in reducing the frequency and intensity of night sweats. Therefore, it can be used to reduce night sweats in postmenopausal women.",2020,"RESULTS


Data analysis revealed that means of hot flashes duration, frequency and intensity did not significantly decrease in the postintervention phase as compared to the pre-intervention phase in both the groups ( P  > 0.05).","['postmenopausal women who were referred to Hamadan health centers in 2018-2019', 'Postmenopausal Women', 'postmenopausal women']","['Menohelp capsule', 'Combined Herbal Capsule Menohelp', 'combined herbal medicine (Menohelp', 'combined herbal capsule (black cohosh, soy, potato, chaste tree, and burdock', 'placebo']","['frequency and intensity of night sweats', 'hot flashes duration, frequency and intensity', 'Hot Flashes and Night Sweats']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0771967', 'cui_str': 'Black Cohosh Extract'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0752339', 'cui_str': 'Chasteberry Tree'}, {'cui': 'C0996995', 'cui_str': 'Burdock, Greater'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0473243,"RESULTS


Data analysis revealed that means of hot flashes duration, frequency and intensity did not significantly decrease in the postintervention phase as compared to the pre-intervention phase in both the groups ( P  > 0.05).","[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Shayan', 'Affiliation': 'Department of Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Seyedeh Zahra', 'Initials': 'SZ', 'LastName': 'Masoumi', 'Affiliation': 'Department of Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran. Zahramid2001@gmail.com.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Kazemi', 'Affiliation': 'Department of Midwifery, Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Khodayar', 'Initials': 'K', 'LastName': 'Oshvandi', 'Affiliation': 'Mother and Child Care Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of menopausal medicine,['10.6118/jmm.20002']
2079,32893536,[Post-marketing pharmaco-economics evaluation of Jinye Baidu Granules].,"To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.",2020,"Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.","['Patients from 10 hospitals', 'acute upper respiratory tract infection']",['Jinye Baidu Granules'],"['baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes', 'total recovery rate of symptoms and signs', 'cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0264222', 'cui_str': 'Acute upper respiratory infection'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",,0.0245879,"Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'School of Pharmacy, Peking University Beijing 100191, China.'}, {'ForeName': 'Yan-Ming', 'Initials': 'YM', 'LastName': 'Xie', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Yan-Shun', 'Initials': 'YS', 'LastName': 'Yu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Jiang', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.'}]",Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica,['10.19540/j.cnki.cjcmm.20200517.501']
2080,32809224,Pediatric randomized trial EORTC CLG 58951: Outcome for adolescent population with acute lymphoblastic leukemia.,"Over the years, the prognosis of adolescents treated for acute lymphoblastic leukemia (ALL) has improved. However, this age group still represents a challenge with an overall survival (OS) of 60% compared to 85% in younger children. Herein, we report the outcome of adolescents treated in the European Organisation for Research and Treatment of Cancer (EORTC) 58951 clinical trial. EORTC 58951 clinical trial included patients with de novo ALL between 1998 and 2008. For this study, we analyzed data of all adolescents between 15 and under 18. Data from 97 adolescents were analyzed, 70 had B-lineage and 27 had T-lineage ALL. The 8-year event-free survival (EFS) and OS for the B-cell precursor ALL cases were 72.3% (59.4%-81.7%) and 80.8% (67.4%-89.1%), respectively. For the T-lineage, the 8-year EFS and OS were 57.4% (36.1%-74.0%) and 59.0% (36.1%-76.2%), respectively. ""B-other"" ALL, defined as BCP-ALL lacking any known recurrent genetic abnormalities were more frequent in our adolescent population (52.8%) than in younger children (27.1%). Outcome of adolescents in the EORTC 58951 study is supporting the findings that adolescents have better outcome in pediatric compared to adults' trials. Nevertheless, in pediatric studies, adolescents still have a worse prognosis than younger children. Despite the fact that specific unfavorable characteristics may be linked to the adolescent population, a careful study and characterization of adolescents ""B-other"" genetic abnormalities in ALL is critical to improve the outcome of this population.",2020,"The 8-year event-free survival (EFS) and OS for the B-cell precursor ALL cases were 72.3% (59.4%-81.7%) and 80.8% (67.4%-89.1%), respectively.","['all adolescents between 15 and under 18', 'patients with de novo', 'adolescent population with acute lymphoblastic leukemia', '97 adolescents were analyzed, 70 had B-lineage and 27 had T-lineage ALL', 'adolescents treated in the European Organisation for Research and Treatment of Cancer (EORTC) 58951 clinical trial']",[],"['8-year EFS and OS', 'overall survival (OS', '8-year event-free survival (EFS) and OS']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",97.0,0.0882408,"The 8-year event-free survival (EFS) and OS for the B-cell precursor ALL cases were 72.3% (59.4%-81.7%) and 80.8% (67.4%-89.1%), respectively.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Olivier-Gougenheim', 'Affiliation': 'Institute of Pediatric Hematology and Oncology, Hospices Civils de Lyon, Claude Bernard Lyon I University, Lyon, France.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Arfeuille', 'Affiliation': 'Department of Genetic Biochemistry, Robert-Debré Hospital, AP-HP and University of Paris-Diderot, Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organization for Research and Treatment of Cancer (EORTC), EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sirvent', 'Affiliation': ""Department of Pediatric and Adolescent Hematology-Oncology, Arnaud de Villeneuve Children's Hospital, Montpellier, France.""}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Plat', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Toulouse University Hospital, Toulouse, France.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Ferster', 'Affiliation': 'Department of Hematology-Oncology, Reine Fabiola Children Hospital, Brussels, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'de Moerloose', 'Affiliation': 'Department of Pediatric Hematology-Oncology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Domenech', 'Affiliation': 'Institute of Pediatric Hematology and Oncology, Hospices Civils de Lyon, Claude Bernard Lyon I University, Lyon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': 'Department of Pediatric Hematology-Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Pierre-Simon', 'Initials': 'PS', 'LastName': 'Rohrlich', 'Affiliation': 'Department of Pediatric Hematology, Archet University Hospital, Nice, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Cavé', 'Affiliation': 'Department of Genetic Biochemistry, Robert-Debré Hospital, AP-HP and University of Paris-Diderot, Paris, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bertrand', 'Affiliation': 'Institute of Pediatric Hematology and Oncology, Hospices Civils de Lyon, Claude Bernard Lyon I University, Lyon, France.'}]",Hematological oncology,['10.1002/hon.2791']
2081,32889846,"Head Rotation Reduces Oropharyngeal Leak Pressure of the i-gel and LMA® Supreme™ in Paralyzed, Anesthetized Patients: A Randomized Trial.","BACKGROUND


Second-generation supraglottic airway (SGA) devices are useful for airway management during positive pressure ventilation in general anesthesia and emergency medicine. In some clinical settings, such as the anesthetic management of awake craniotomy, SGAs are used in the head-rotated position, which is required for exposure of the surgical field, although this position sometimes worsens the efficiency of mechanical ventilation with SGAs. In this study, we investigated and compared the influence of head rotation on oropharyngeal leak pressures (OPLP) of the i-gel and LMA® Supreme™ which are second-generation SGA devices.
METHODS


Patients who underwent elective surgery under general anesthesia were enrolled in this study and randomly divided into i-gel or LMA Supreme groups. After induction of anesthesia with muscle relaxation, the i-gel or LMA Supreme was inserted according to computerized randomization. The primary outcome was the OPLP at 0°, 30°, and 60° head rotation. The secondary outcomes were the maximum airway pressure and expiratory tidal volume when patients were mechanically ventilated using a volume-controlled ventilation mode with a tidal volume of 10 mL/kg (ideal body weight), ventilation score, and fiber-optic views of vocal cords.
RESULTS


Thirty-four and 36 participants were included in the i-gel and LMA Supreme groups, respectively. The OPLPs of the i-gel and LMA Supreme significantly decreased as the head rotation angle increased (mean difference [95% confidence interval], P value: i-gel; 0° vs 30°: 3.5 [2.2-4.8], P < .001; 30° vs 60°: 2.0 [0.6-3.5], P = .002; 0° vs 60°: 5.5 [3.3-7.8], P < .001, LMA Supreme; 0° vs 30°: 4.1 [2.6-5.5], P < .001; 30° vs 60°: 2.4 [1.1-3.7], P < .001; 0° vs 60°: 6.5 [5.1-8.0], P < .001). There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group. There was no statistically significant difference between the 2 devices in all outcome measures. The incidences of adverse events, such as hoarseness or sore throat, were not significantly different between i-gel and LMA Supreme.
CONCLUSIONS


Head rotation to 30° and 60° reduces OPLP with both i-gel and LMA Supreme. There is no difference in OPLP between i-gel and LMA Supreme in the 3 head rotation positions.",2020,There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group.,"['Paralyzed, Anesthetized Patients', 'Thirty-four and 36 participants were included in the i-gel and LMA Supreme groups, respectively', 'Patients who underwent elective surgery under general anesthesia']","[' i-gel', 'Second-generation supraglottic airway ', 'Head Rotation', 'head rotation']","['ventilation score', 'maximum airway pressure and expiratory tidal volume', 'expiratory tidal volume and ventilation score', 'adverse events, such as hoarseness or sore throat', 'head rotation angle', 'tidal volume of 10 mL/kg (ideal body weight), ventilation score, and fiber-optic views of vocal cords', 'OPLP at 0°, 30°, and 60° head rotation', 'OPLP', 'Oropharyngeal Leak Pressure', 'oropharyngeal leak pressures (OPLP']","[{'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0015979', 'cui_str': 'Fiber Optic Technology'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.121973,There were statistically significant differences in expiratory tidal volume and ventilation score between 0° and 60° in the i-gel group and in ventilation score between 30° and 60° in the LMA Supreme group.,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Chaki', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Tachibana', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kumita', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Honami', 'Initials': 'H', 'LastName': 'Sato', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Hamada', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'From the Department of Anesthesiology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005150']
2082,32889859,Research on the Effects of a Web-Based System with Oculomotor and Optokinetic Stimuli on Vestibular Rehabilitation.,"OBJECTIVE


The variety and use of technologies used in vestibular rehabilitation is very limited. The purpose of this study was to investigate the effects of a web-based system on vestibular rehabilitation in patients with vestibular hypofunction.
DESIGN


20 patients with unilateral vestibular hypofunction were randomly assigned to two groups. Conventional vestibular rehabilitation was applied to the control group, whereas the study group received treatment with the web-based system supporting the vestibulo-ocular reflex with oculomotor and optokinetic stimulus (SVORE-Simulation of Vestibulo-Ocular Reflex Exercises). Vestibular and balance tests, oculomotor level, Tampa Kinesiophobia Scale (TKS) and Dizziness Handicap Inventory (DHI) were used to evaluate the efficacy treatment's.
RESULTS


Vestibular symptoms and findings, balance tests, oculomotor functions, Tampa Kinesiophobia Scale and Dizziness Handicap Inventory improved significantly in both of the groups after the interventions (p<0.05). In the intergroup analysis, improvement was found in eyes closed Romberg, semi-tandem and left one-foot position balance tests in favor of the study group (p<0.05).
CONCLUSION


The new vestibular technology, SVORE was found to be effective in vestibular rehabilitation.",2020,"In the intergroup analysis, improvement was found in eyes closed Romberg, semi-tandem and left one-foot position balance tests in favor of the study group (p<0.05).
","['patients with vestibular hypofunction', '20 patients with unilateral vestibular hypofunction']","['Web-Based System with Oculomotor and Optokinetic Stimuli on Vestibular Rehabilitation', 'Conventional vestibular rehabilitation', 'web-based system supporting the vestibulo-ocular reflex with oculomotor and optokinetic stimulus (SVORE-Simulation of Vestibulo-Ocular Reflex Exercises', 'web-based system on vestibular rehabilitation']","['Vestibular and balance tests, oculomotor level, Tampa Kinesiophobia Scale (TKS) and Dizziness Handicap Inventory (DHI', 'eyes closed Romberg, semi-tandem and left one-foot position balance tests', 'Vestibular symptoms and findings, balance tests, oculomotor functions, Tampa Kinesiophobia Scale and Dizziness Handicap Inventory']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0034944', 'cui_str': 'Vestibulo-ocular reflex'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015458', 'cui_str': 'Facial hemiatrophy'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",20.0,0.0128144,"In the intergroup analysis, improvement was found in eyes closed Romberg, semi-tandem and left one-foot position balance tests in favor of the study group (p<0.05).
","[{'ForeName': 'Gonul Ertunc', 'Initials': 'GE', 'LastName': 'Gulcelik', 'Affiliation': 'Graduate School of Health Sciences, Physical Therapy and Rehabilitation Ph.D Program, Istanbul Medipol University, Istanbul, Turkey gonulertunc@gmail.com (GGE); Istanbul Medipol University, School Of Health Science, Division Of Ergotherapy, Istanbul, Turkey. dtarakci@medipol.edu.tr (DT); Acıbadem Maslak Hospital, Department Of Audiology, Istanbul, Turkey. ozlem.soyuyuce@acibadem.com (OGS); Acıbadem Maslak Hospital, Department Of Audiology, Istanbul, Turkey. zeynep.gumus@acibadem.com (ZGG);Acıbadem Maslak Hospital, Department Of Ear Nose And Throat, Istanbul, Turkey. nazim.korkut@acibadem.com (NK); Istanbul Medipol University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Turkey. calgun@medipol.edu.tr (ZCA).'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': ''}, {'ForeName': 'Ozlem Gedik', 'Initials': 'OG', 'LastName': 'Soyuyuce', 'Affiliation': ''}, {'ForeName': 'Zeynep Gence', 'Initials': 'ZG', 'LastName': 'Gumus', 'Affiliation': ''}, {'ForeName': 'Nazım', 'Initials': 'N', 'LastName': 'Korkut', 'Affiliation': ''}, {'ForeName': 'Zeliha Candan', 'Initials': 'ZC', 'LastName': 'Algun', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001584']
2083,32889867,mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors.,"OBJECTIVE


The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial).
SUMMARY AND BACKGROUND DATA


Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects. In the SiLVER-trial (Clinicaltrials.gov: NCT00355862), the effect of sirolimus on the recurrence of HCC after LT was investigated in a prospective randomized trial. Although the primary endpoint of improved disease-free survival (DFS) with sirolimus was not met, outcomes were improved for patients in the sirolimus-treatment arm in the first 3 to 5 years. To learn more about the key variables, a multivariate analysis was performed on the SiLVER-trial data.
PATIENTS AND METHODS


Data from 508 patients of the intention-to-treat analysis were included in exploratory univariate and multivariate models for overall survival (OS), DFS and a competing risk analysis for HCC recurrence.
RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02). Most strikingly, patients with an alpha-fetoprotein (AFP) ≥10 ng/mL and having used sirolimus for ≥3 months, benefited most with regard to OS, DFS, and HCC-recurrence (HR: 0.49-0.59, P = 0.0079-0.0245).
CONCLUSIONS


mTOR-inhibitor treatment with sirolimus for ≥3 months improves outcomes in LT for HCC, especially in patients with AFP-evidence of higher tumor activity, advocating particularly for mTOR inhibitor use in this subgroup of patients.
CLINICAL TRIAL REGISTRATION


EudraCT: 2005-005362-36 CLINICALTRIALS.GOV:: NCT00355862.",2020,"RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02).","['Data from 508 patients of the intention-to-treat analysis', 'Patients With Active Tumors', 'patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial', 'patients with an alpha-fetoprotein (AFP) ≥10']","['mTOR', 'sirolimus', 'Calcineurin inhibitors']","['OS, DFS, and HCC-recurrence', 'disease-free survival (DFS', 'overall survival (OS), DFS and a competing risk analysis for HCC recurrence', 'survival benefit', 'hazard for death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.230694,"RESULTS


Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02).","[{'ForeName': 'Andreas A', 'Initials': 'AA', 'LastName': 'Schnitzbauer', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Filmann', 'Affiliation': 'Universitätsklinikum Frankfurt, Institut für Biostatistik und Mathematisches Modellierung, Frankfurt am Main, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'Hôpital Paul Brousse, Centre Hépato Biliaire, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bachellier', 'Affiliation': 'Les Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre, Service de Chirurgie Générale, Hépatique, Endocrinienne, et Transplantation, Strasbourg, France.'}, {'ForeName': 'Wolf O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Universitätsklinikum Schleswig-Holstein - Campus Kiel, Klinik für Allgemeine Chirurgie, Viszeral-, Thorax, Transplantations- und Kinderchirurgie, Kiel, Germany.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Bhoori', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Milano, Italy.'}, {'ForeName': 'Itxarone', 'Initials': 'I', 'LastName': 'Bilbao', 'Affiliation': ""Hospital Universitari Vall d'Hebron, Servicio de Cirugía General, Unidad de Trasplante Hepatico, Barcelona, Spain.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Brockmann', 'Affiliation': 'Universitätsklinikum Münster, Klinik für Allgemein- und ViszeralchirurgieMünster, Germany.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Burra', 'Affiliation': 'Università degli Studi di Padova, Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche (DiSCOG), Padova, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chazoullières', 'Affiliation': ""Hôpital Saint Antoine, Federation d'Hepato-Gastro-Enterologie, Service d'Hepatologie, Paris, France.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Cillo', 'Affiliation': 'Università di Padova, Azienda Ospedaliera di Padova, Chirurgia Epatobiliare e Trapianto Epatico, Padova, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Colledan', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Chirurgia terza e Chirurgia Toracica, Bergamo (BG), Italy.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Duvoux', 'Affiliation': ""Université Paris-Est Créteil Val-de-Marne, Centre Hospitalier Universitaire Henri-Mondor, Service d'Hepatologie et de Gastroenterologie, Unite d'Hepatologie et de Transplantation Hepatique, Paris, France.""}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Ganten', 'Affiliation': 'Universitätsklinikum Heidelberg, Fürst Stirum Klinik Bruchsal, Bruchsal, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gugenheim', 'Affiliation': 'Centre Hospitalier Universitaire de Nice, Hôpital ARCHET 2, Service de Chirurgie Digestive, Centre de Transplantation Hépatique, Nice Cedex, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heise', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'van Hoek', 'Affiliation': 'Leiden University Medical Center (LUMC), Dept. of Gastroenterology and Hepatology, Leiden, Netherlands.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Jamieson', 'Affiliation': ""Cambridge University Hospitals, NHS Foundation Trust, Addenbrooke's Hospital, Department of Surgery, Hills Road, Cambridge, United Kingdom.""}, {'ForeName': 'Koert P', 'Initials': 'KP', 'LastName': 'de Jong', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Department of Surgery, Div. of Hepato-Pancreatico-Biliary Surgery & Liver Transplantation, Groningen, Netherlands.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Klein', 'Affiliation': 'Universitätsklinikum Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Essen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Klempnauer', 'Affiliation': 'Medizinische Hochschule Hannover, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Hannover, Germany.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Kneteman', 'Affiliation': 'University of Alberta, Alberta Health Services Liver Transplant Program, Alberta, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lerut', 'Affiliation': 'Institute for Experimental and Clinical Research (IREC), Université catholique Louvain(UCL), Brussels, Belgium.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'Helsinki University Central Hospital, Division of Transplantation and Liver Surgery, Helsinki, Finland.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, National Cancer Institute Milan, Department of Surgery, Transplantation and Hepatobiliary Cancer Unit, Milano, Italy.'}, {'ForeName': 'Darius F', 'Initials': 'DF', 'LastName': 'Mirza', 'Affiliation': 'University Hospitals Birmingham, NHS Foundation Trust, The Queen Elizabeth Hospital, Liver and Hepato-Pancreato-Biliary (HPB) Unit, Edgbaston, Birmingham, United Kingdom.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Nadalin', 'Affiliation': 'Klinikum der Universität Tübingen, Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Tübingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Neuhaus', 'Affiliation': 'Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Allgemein-, Visceral- und Transplantationschirurgie, Berlin, Germany.'}, {'ForeName': 'George-Philippe', 'Initials': 'GP', 'LastName': 'Pageaux', 'Affiliation': ""CHRU de Montpellier, APEMAD, Hôpital Saint-Eloi, Service d'Hepato-Gastroentérologie et Transplantation Hepatique, Cedex 5, France.""}, {'ForeName': 'Antonio D', 'Initials': 'AD', 'LastName': 'Pinna', 'Affiliation': 'Universita di Bologna, Policlinico S. Orsola-Malpighi, Chirurgia Generale e dei Trapianti, Bologna, Italy.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Pirenne', 'Affiliation': 'UZ Leuven, Campus Gasthuisberg, Abdominale Transplantatiechirurgie, Leuven, Belgium.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Charité - Universitätsmedizin Berlin Augustenburger Platz 1, 13353 Berlin.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Powel', 'Affiliation': 'Royal Infirmary of Edinburgh, NHS Lothian, Hepatic-Pancreatico-Biliary Surgical Services and Edinburgh Transplant Unit, 51 Little France Crescent, Edinburgh, Scotland, United Kingdom.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rentsch', 'Affiliation': 'Klinikum der Ludwig-Maximillians-Universität München-Großhadern, current affiliation: Klinikum Ingolstadt, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Ingolstadt, Germany.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Rizell', 'Affiliation': 'Sahlgrenska University Hospital, Department of Surgery and Transplantation, Göteborg, Sweden.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Rossi', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico IRCCS di Milano, Centro Trapianti Fegato, Pad Zonda I piano, Milano, Italy.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Rostaing', 'Affiliation': 'Department of Nephrology, Hemodialysis, Apheresis and Transplantation, Grenoble-Alpes University Hospital Center, Avenue du Maquis du Grésivaudan, La Tronche, France.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Roy', 'Affiliation': ""Hopital St Luc, Centre Hospitalier de l'Université Montréal (CHUM), Hepatobiliary and Pancreatic Surgery Unit, Principal Pavillion, 1058 Rue St Denis Montreal, Quebec, Canada.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Scholz', 'Affiliation': 'Uppsala University Hospital, Deptartment for Transplant Surgery, Uppsala, Sweden.'}, {'ForeName': 'Utz', 'Initials': 'U', 'LastName': 'Settmacher', 'Affiliation': 'Universitätsklinikum Jena, Klinik für Allgemein-, Viszeral- und Gefässchirurgie, Jena, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Soliman', 'Affiliation': 'Medizinische Universität Wien, AKH- Wien, Universitätsklinik für Chirurgie, Abteilung für Transplantation, Vienna, Austria.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Strasser', 'Affiliation': 'Royal Prince Alfred Hospital, AW Morrow Gastroenterology, and Liver Centre and Liver Transplant Unit, Camperdown, Sydney, Australia.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Söderdahl', 'Affiliation': 'Karolinska University Hospital, Department of Transplantation Surgery, Stockholm, Sweden.'}, {'ForeName': 'Roberto I', 'Initials': 'RI', 'LastName': 'Troisi', 'Affiliation': 'Ghent University Hospital and Medical School, Hepato- Biliary and Pancreatic Surgery, Ghent, Belgium.'}, {'ForeName': 'Victor Sánchez', 'Initials': 'VS', 'LastName': 'Turrión', 'Affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda, Departamento de Cirugía, Unidad de Trasplante Hepático, Calle Manuel de Falla 1, Madrid, Spain.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Schlitt', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Geissler', 'Affiliation': 'Universitätsklinikum Frankfurt, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie, Frankfurt am Main, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000004280']
2084,32889869,Efficacy and Safety of the Duodeno-Jejunal Bypass Liner in Patients With Metabolic Syndrome: A Multicenter Randomized Controlled Trial (ENDOMETAB).,"OBJECTIVE


The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS).
SUMMARY BACKGROUND DATA


DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study.
METHODS


We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed.
RESULTS


A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%.
CONCLUSIONS


The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.",2020,No difference remained statistically significant at 12 months after the removal of the DJBL.,"['Patients With Metabolic Syndrome', '174 subjects', 'patients with MS', 'patients with metabolic syndrome (MS', 'A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes']","['Duodeno-Jejunal Bypass Liner', 'duodeno-jejunal bypass liner (DJBL) with conventional medical care']","['body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again', 'efficacy and safety', 'BMI loss', 'Efficacy and Safety', 'weight loss and glucose control', 'remission of MS', 'premature device explantation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0022378', 'cui_str': 'Jejunal'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0561946', 'cui_str': 'Removal of implant'}]",174.0,0.238675,No difference remained statistically significant at 12 months after the removal of the DJBL.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Caiazzo', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Branche', 'Affiliation': 'CHU Lille, Department of Gastroenterology, Lille, France.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Raverdy', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Czernichow', 'Affiliation': ""University of Paris, Paris, France, AP-HP, Department of Nutrition, Centre spécialisé de l'Obesité Ile-de-France Sud, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Carette', 'Affiliation': ""University of Paris, Paris, France, AP-HP, Department of Nutrition, Centre spécialisé de l'Obesité Ile-de-France Sud, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': 'Department of Digestive and Bariatric Surgery, Integrated Center of Obesity, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Integrated Center of Obesity, Hospices Civils de Lyon, Hôpital Lyon Sud, Pierre Benite, France, CarMeN Laboratory, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Barthet', 'Affiliation': ""Service d'Hépato-gastroentérologie, Hôpital Nord, Marseille, France.""}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""Clinique d'endocrinologie, L'institut du thorax, CHU Nantes, Nantes, France.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Msika', 'Affiliation': 'Department of General, Digestive and Metabolic Surgery, Bichat Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Behal', 'Affiliation': 'University Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Fanette', 'Initials': 'F', 'LastName': 'Denies', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), CHU Lille, Lille, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Dervaux', 'Affiliation': ""Délégation à la Recherche Clinique et à l'Innovation (DRCI), CHU Lille, Lille, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Duhamel', 'Affiliation': 'University Lille, CHU Lille, ULR 2694-METRICS: Évaluation des technologies de santé et des pratiques médicales, Lille, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Verkindt', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Pattou', 'Affiliation': 'University Lille, Inserm, CHU Lille, Institut Pasteur Lille U1190 Translational Research for Diabetes, European Genomic Institute for Diabetes, Integrated Center of Obesity, Lille, France.'}]",Annals of surgery,['10.1097/SLA.0000000000004339']
2085,32889876,Assessment of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the short-term outcomes of patients with gastric cancer (GC) who received robotic distal gastrectomy (RDG) or laparoscopic distal gastrectomy (LDG).
SUMMARY BACKGROUND DATA


Despite the increasing use of RDG in patients with GC, its safety and efficacy compared to those of LDG have not been elucidated in a randomized controlled trial (RCT).
METHODS


Three hundred patients with cT1-4a and N0/+ between September 2017 and January 2020 were enrolled in this RCT at a high-volume hospital in China. The short-term outcomes were compared between the groups.
RESULTS


The modified intention-to-treat analysis included data from 283 patients (RDG group: n = 141) and (LDG group: n = 142). Patients in the RDG group exhibited faster postoperative recovery, milder inflammatory responses, and reduced postoperative morbidity (9.2% vs. 17.6%, respectively, p = 0.039). Higher extraperigastric lymph nodes (LNs) were retrieved in the RDG group (17.6 ± 5.8 vs. 15.8 ± 6.6, p = 0.018) with lower noncompliance rate (7.7% vs. 16.9%, respectively, p = 0.006). Additionally, patients in the RDG group were more likely to initiate adjuvant chemotherapy earlier (median [interquartile range] postoperative days: 28 [24-32] vs. 32 [26-42], p = 0.003). Although total hospital costs were higher in the robotic group than in the laparoscopic group, the direct cost was lower for RDG than for LDG (all p < 0.001).
CONCLUSIONS


RDG is associated with a lower morbidity rate, faster recovery, milder inflammatory responses, and improved lymphadenectomy. Additionally, faster postoperative recovery in the RDG group enables early initiation of adjuvant chemotherapy. Our results provide evidence for the application of RDG in patients with GC.",2020,"Although total hospital costs were higher in the robotic group than in the laparoscopic group, the direct cost was lower for RDG than for LDG (all p < 0.001).
","['283 patients (RDG group: n = 141) and (LDG group: n = 142', 'Three hundred patients with cT1-4a and N0/+ between September 2017 and January 2020 were enrolled in this RCT at a high-volume hospital in China', 'Gastric Cancer', 'patients with gastric cancer (GC', 'patients with GC']","['robotic distal gastrectomy (RDG) or laparoscopic distal gastrectomy (LDG', 'Robotic Versus Laparoscopic Distal Gastrectomy']","['postoperative recovery, milder inflammatory responses', 'total hospital costs', 'Higher extraperigastric lymph nodes (LNs', 'noncompliance rate', 'morbidity rate, faster recovery, milder inflammatory responses, and improved lymphadenectomy', 'likely to initiate adjuvant chemotherapy earlier', 'direct cost', 'postoperative morbidity']","[{'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3494218', 'cui_str': 'High-Volume Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",300.0,0.146081,"Although total hospital costs were higher in the robotic group than in the laparoscopic group, the direct cost was lower for RDG than for LDG (all p < 0.001).
","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'Xu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}]",Annals of surgery,['10.1097/SLA.0000000000004466']
2086,32889881,Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants vs. Warfarin for post Cardiac Surgery Atrial Fibrillation: The NEW-AF Trial.,": New onset atrial fibrillation commonly occurs following cardiac surgery and is associated with increased rates of stroke and mortality. In non-surgical patients with atrial fibrillation, novel oral anticoagulants (NOACs) have been shown to confer equivalent benefits for stroke prevention with less bleeding risk and less tedious monitoring requirements compared with Warfarin. However, NOACs have yet to be adopted widely in cardiac surgery patients. The NEW-AF study has been designed as a pragmatic, prospective, randomized controlled trial that will compare financial, convenience and safety outcomes for patients with new onset atrial fibrillation after cardiac surgery who are treated with NOACs versus Warfarin. Study results may contribute to optimizing the options for stroke prophylaxis in cardiac surgery patients and catalyze more widespread application of NOAC therapy in this patient population. The trial is registered with clinicaltrials.gov under registration number NCT03702582Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants vs. Warfarin for post Cardiac Surgery Atrial Fibrillation: The NEW-AF Trial.",2020,"In non-surgical patients with atrial fibrillation, novel oral anticoagulants (NOACs) have been shown to confer equivalent benefits for stroke prevention with less bleeding risk and less tedious monitoring requirements compared with Warfarin.","['post Cardiac Surgery Atrial Fibrillation', 'non-surgical patients with atrial fibrillation', 'cardiac surgery patients', 'patients with new onset atrial fibrillation after cardiac surgery who are treated with']","['Warfarin', 'novel oral anticoagulants (NOACs', 'NOACs versus Warfarin', 'New Oral Anticoagulants vs. Warfarin']",['rates of stroke and mortality'],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.252598,"In non-surgical patients with atrial fibrillation, novel oral anticoagulants (NOACs) have been shown to confer equivalent benefits for stroke prevention with less bleeding risk and less tedious monitoring requirements compared with Warfarin.","[{'ForeName': 'Asishana A', 'Initials': 'AA', 'LastName': 'Osho', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Philicia', 'Initials': 'P', 'LastName': 'Moonsamy', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Breanna R', 'Initials': 'BR', 'LastName': 'Ethridge', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Leya', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': ""D'Alessandro"", 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Arminder S', 'Initials': 'AS', 'LastName': 'Jassar', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mauricio A', 'Initials': 'MA', 'LastName': 'Villavicencio', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Serguei I', 'Initials': 'SI', 'LastName': 'Melnitchouk', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tolis', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Nathaniel B', 'Initials': 'NB', 'LastName': 'Langer', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Funamoto', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Selena S', 'Initials': 'SS', 'LastName': 'Li', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Katia M', 'Initials': 'KM', 'LastName': 'Colon', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Navyatha', 'Initials': 'N', 'LastName': 'Mohan', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Harvard Catalyst Biostatistical Group, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Lubitz', 'Affiliation': 'Division of Cardiology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': 'Department of Anesthesia, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thoralf M', 'Initials': 'TM', 'LastName': 'Sundt', 'Affiliation': 'Division of Cardiac Surgery, Massachusetts General Hospital, Boston, MA.'}]",Annals of surgery,['10.1097/SLA.0000000000004459']
2087,32889912,Intensive statin versus low-dose statin + ezetimibe treatment for fibrous cap thickness of coronary vulnerable plaques.,"BACKGROUND


Acute coronary syndromes mainly result from abrupt thrombotic occlusion caused by atherosclerotic vulnerable plaques (VPs) that suddenly rupture or erosion. Fibrous cap thickness (FCT) is a major determinant of the propensity of a VP to rupture and is recognized as a key factor. The intensive use of statins is known to have the ability to increase FCT; however, there is a risk of additional adverse effects. However, lower dose statin with ezetimibe is known to be tolerable by patients. The present study aimed to investigate the effect of intensive statin vs. low-dose stain + ezetimibe therapy on FCT, as evaluated using optical coherence tomography.
METHOD


Patients who had VPs (minimum FCT <65 μm and lipid core >90°) and deferred from intervention in our single center from January 2014 to December 2018 were included in the trial. They were divided into the following two groups: intensive statin group (rosuvastatin 15-20 mg or atorvastatin 30-40 mg) and combination therapy group (rosuvastatin 5-10 mg or atorvastatin 10-20 mg + ezetimibe 10 mg). At the 12-month follow-up, we compared the change in the FCT (ΔFCT%) between the two groups and analyzed the association of ΔFCT% with risk factors. Fisher exact test was used for all categorical variables. Student's t test or Mann-Whitney U-test was used for analyzing the continuous data. The relationship between ΔFCT% and risk factors was analyzed using linear regression analysis.
RESULT


Total 53 patients were finally enrolled, including 26 patients who were in the intensive statin group and 27 who were in the combination therapy group. At the 12-month follow-up, the serum levels of total cholesterol (TC), total triglyceride, low-density lipoprotein (LDL-C), hypersensitive C-reactive protein (hs-CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) levels were reduced in both the groups. The ΔTC%, ΔLDL-C%, and ΔLp-PLA2% were decreased further in the combination therapy group. FCT was increased in both the groups (combination treatment group vs. intensive statin group: 128.89 ± 7.64 vs. 110.19 ± 7.00 μm, t = -9.282, P < 0.001) at the 12-month follow-up. The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001). Based on the multivariate linear regression analysis, only the serum Lp-PLA2 at the 12-month follow-up (B = -0.203, t = -2.701, P = 0.010), ΔTC% (B = -0.573, t = -2.048, P = 0.046), and Δhs-CRP% (B = -0.302, t = -2.963, P = 0.005) showed an independent association with ΔFCT%.
CONCLUSIONS


Low-dose statin combined with ezetimibe therapy maybe provide a profound and significant increase in FCT as compared to intensive statin monotherapy. The reductions in Lp-PLA2, ΔTC%, and Δhs-CRP% are independently associated with an increase in FCT.",2020,"The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001).","['Patients who had VPs (minimum FCT', 'fibrous cap thickness of coronary vulnerable plaques', 'Total 53 patients were finally enrolled, including 26 patients who were in the intensive statin group and 27 who were in the combination therapy group', '90°) and deferred from intervention in our single center from January 2014 to December 2018 were included in the trial']","['intensive statin vs. low-dose stain + ezetimibe therapy', 'ezetimibe', 'Intensive statin versus low-dose statin + ezetimibe', 'Fibrous cap thickness (FCT', 'intensive statin group (rosuvastatin 15-20 mg or atorvastatin 30-40 mg) and combination therapy group (rosuvastatin 5-10 mg or atorvastatin 10-20 mg + ezetimibe']","['serum levels of total cholesterol (TC), total triglyceride, low-density lipoprotein (LDL-C), hypersensitive C-reactive protein (hs-CRP), and lipoprotein-associated phospholipase A2 (Lp-PLA2) levels', 'ΔFCT', 'FCT', 'Lp-PLA2, ΔTC%, and Δhs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031667', 'cui_str': 'Phospholipase A>2<'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",53.0,0.0232764,"The increase in ΔFCT% was more in the combination therapy group (123.46% ± 14.05% vs. 91.14% ± 11.68%, t = -9.085, P < 0.001).","[{'ForeName': 'Pei-Na', 'Initials': 'PN', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'De-Lu', 'Initials': 'DL', 'LastName': 'Yin', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Lianyungang, Lianyungang, Jiangsu 222000, China.""}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Xiang-Qi', 'Initials': 'XQ', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu 210006, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000001067']
2088,32889959,Novel Bioenhanced Curcumin With Mesalamine for Induction of Clinical and Endoscopic Remission in Mild-to-Moderate Ulcerative Colitis: A Randomized Double-Blind Placebo-controlled Pilot Study.,"BACKGROUND AND AIMS


The aim of this study was to assess the efficacy and safety of a novel, hydrophilic, bioenhanced curcumin (BEC) as add-on therapy in inducing clinical and endoscopic remission in mild to moderately active ulcerative colitis (UC).
DESIGN


Mild to moderately active UC patients (partial Mayo score 2 to 6 with endoscopic Mayo score >1) on standard dose of mesalamine were randomized to either 50 mg twice daily BEC or an identical placebo. Clinical response (≥2 reduction of partial Mayo score), clinical remission (partial Mayo score ≤1), and endoscopic remission (endoscopic Mayo score of ≤1) were evaluated at 6 weeks and 3 months. Responders were followed-up at 6 and 12 months for assessing maintenance of remission.
RESULTS


Sixty-nine patients were randomly assigned to BEC (n=34) and placebo (n=35). At 6 weeks, clinical and endoscopic remission occurred in 44.1% (15/34) and 35.3% (14/34) patients, respectively, compared with none in the placebo group (P<0.01). Clinical response was also significantly higher in the BEC group (18/34, 52.9%) compared with placebo (5/35, 14.3%) (P=0.001). The clinical remission, clinical response, and endoscopic remission rates at 3 months were 55.9% (19/34), 58.8% (20/34), 44% (16/34) and 5.7% (2/35), 28.6% (10/35), 5.7% (2/35) in BEC and placebo groups, respectively. At 6 and 12 months, 95% (18/19) and 84% (16/19) of the responders to BEC maintained clinical remission. None of the responders to placebo maintained clinical remission at 6 months. BEC appeared safe with no significant side effects.
CONCLUSION


A low-dose BEC as add-on therapy was superior to placebo in inducing sustained clinical and endoscopic remission in patients with mild-to-moderately active UC on maximal dose of mesalamine (ClinicalTrials.gov: NCT02683733).",2020,"Clinical response was also significantly higher in the BEC group (18/34, 52.9%) compared with placebo (5/35, 14.3%) (P=0.001).","['Mild to moderately active UC patients', 'Sixty-nine patients', 'Mild-to-Moderate Ulcerative Colitis', 'mild to moderately active ulcerative colitis (UC']","['mesalamine', '50\u2009mg twice daily BEC or an identical placebo', 'placebo', 'novel, hydrophilic, bioenhanced curcumin (BEC', 'BEC', 'Placebo', 'Mesalamine']","['Clinical response (≥2 reduction of partial Mayo score), clinical remission (partial Mayo score ≤1), and endoscopic remission (endoscopic Mayo score of ≤1', 'clinical and endoscopic remission', 'Clinical response', 'sustained clinical and endoscopic remission', 'efficacy and safety', 'clinical remission', 'clinical remission, clinical response, and endoscopic remission rates']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0475370', 'cui_str': 'Hydrophilic'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",69.0,0.672759,"Clinical response was also significantly higher in the BEC group (18/34, 52.9%) compared with placebo (5/35, 14.3%) (P=0.001).","[{'ForeName': 'Rupa', 'Initials': 'R', 'LastName': 'Banerjee', 'Affiliation': 'Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Amulya', 'Initials': 'A', 'LastName': 'Penmetsa', 'Affiliation': 'SUNY Upstate Medical University in Syracuse, Syracuse, NY.'}, {'ForeName': 'Pradip', 'Initials': 'P', 'LastName': 'Kathi', 'Affiliation': 'John D. Dingell VA Medical Center, Detroit Medical Center/Wayne State University, 4646 John R Street, Detroit, MI.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Girish', 'Affiliation': 'Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Goren', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva.'}, {'ForeName': 'D Nageshwar', 'Initials': 'DN', 'LastName': 'Reddy', 'Affiliation': 'Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001416']
2089,32890015,Effects of magnesium on the dose of rocuronium for deep neuromuscular blockade: A randomised controlled trial.,"BACKGROUND


Magnesium is known to enhance the effect of rocuronium, but the extent is not quantified.
OBJECTIVES


We aimed to quantify the effect of magnesium on the dose of rocuronium for deep neuromuscular blockade.
DESIGN


A randomised controlled study.
SETTING


A single tertiary care hospital.
PATIENTS


Seventy males scheduled to undergo robot-assisted laparoscopic prostatectomy, aged between 20 and 80 years with American Society of Anesthesiologists physical status classification 1 or 2, were enrolled.
INTERVENTIONS


Patients were randomised to either the magnesium group or control group. The magnesium group were infused with 50 mg kg of magnesium, followed by a continuous intra-operative infusion at 15 mg kg h while the control group were infused with the same volumes of 0.9% saline. Deep neuromuscular blockade was maintained with a continuous infusion of rocuronium and was reversed using sugammadex.
MAIN OUTCOME MEASURES


The primary outcome was the dose of rocuronium administered to maintain deep neuromuscular blockade. The secondary outcomes were recovery time, defined as the time from the administration of sugammadex to train-of-four ratio 0.9, and the incidence of postoperative nausea and vomiting.
RESULTS


The dose of rocuronium administered to maintain deep neuromuscular blockade was significantly lower in the magnesium group (7.5 vs. 9.4 μg kg min, P = 0.01). There was no difference in recovery time or the incidence of nausea and vomiting.
CONCLUSION


Magnesium reduced the dose of rocuronium required for deep neuromuscular blockade by approximately 20% without affecting the recovery time after administration of sugammadex.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT04013243.",2020,"There was no difference in recovery time or the incidence of nausea and vomiting.
","['Seventy males scheduled to undergo robot-assisted laparoscopic prostatectomy, aged between 20 and 80 years with American Society of Anesthesiologists physical status classification 1 or 2, were enrolled', 'deep neuromuscular blockade', 'A single tertiary care hospital']","['magnesium', 'Magnesium', 'rocuronium', 'magnesium group or control group', '50\u200amg\u200akg of magnesium']","['recovery time', 'deep neuromuscular blockade', 'nausea and vomiting', 'recovery time, defined as the time from the administration of sugammadex to train-of-four ratio 0.9, and the incidence of postoperative nausea and vomiting']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450990', 'cui_str': 'American Society of Anesthesiologists physical status classification'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0428698', 'cui_str': 'Train of four ratio'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",70.0,0.689289,"There was no difference in recovery time or the incidence of nausea and vomiting.
","[{'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam (JH, Y-TJ, J-HR, C-HK, SWN, S-IC, A-YO) and Department of Anesthesiology and Pain Medicine, Seoul National University, Seoul, South Korea (Y-TJ, J-HR, A-YO).'}, {'ForeName': 'Young-Tae', 'Initials': 'YT', 'LastName': 'Jeon', 'Affiliation': ''}, {'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': ''}, {'ForeName': 'Chang-Hoon', 'Initials': 'CH', 'LastName': 'Koo', 'Affiliation': ''}, {'ForeName': 'Sun Woo', 'Initials': 'SW', 'LastName': 'Nam', 'Affiliation': ''}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Ah-Young', 'Initials': 'AY', 'LastName': 'Oh', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001329']
2090,32890016,Effects of high-flow nasal oxygen during prolonged deep sedation on postprocedural atelectasis assessed by computerised tomography: A randomised controlled trial.,"BACKGROUND


Atelectasis is common in patients undergoing prolonged deep sedation outside the operating theatre. High-flow nasal oxygen (HFNO) produces positive airway pressure which, hypothetically, should improve lung atelectasis, but this has not been investigated.
OBJECTIVE


We investigated whether HFNO ameliorates postprocedural atelectasis and compared the influences of HFNO and facial oxygen by mask on postprocedural outcomes.
DESIGN


A single-blind, open-label single-institution randomised controlled trial.
SETTING


A single university hospital, from February 2017 to July 2019.
PATIENTS


A total of 59 patients undergoing computed tomography (CT)-guided hepatic tumour radiofrequency ablation were randomly allocated to two groups.
INTERVENTION


These patients randomly received HFNO (oxygen flow 10 l min before sedation and 50 l min during the procedure) or a conventional oxygen face mask (oxygen flow 10 l min) during the procedure.
MAIN OUTCOME MEASURES


Changes in the area of lung atelectasis calculated on the basis of chest CT images and also recovery profiles were compared between the two groups.
RESULTS


The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313). However, the numbers of patients requiring oxygen supplementation in the recovery room and during transport from the recovery room to the ward did not differ significantly between groups (24.1 vs. 50.0%; P = 0.0596).
CONCLUSION


Our results suggested that HFNO ameliorates lung atelectasis after prolonged deep sedation in patients receiving CT-guided hepatic tumour radiofrequency ablation.
TRIAL REGISTRATION


Clinicaltrials.gov Identifier: NCT03019354.",2020,"The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313).","['A single university hospital, from February 2017 to July 2019', '59 patients undergoing computed tomography (CT)-guided hepatic tumour radiofrequency ablation', 'patients undergoing prolonged deep sedation outside the operating theatre', 'patients receiving CT-guided hepatic tumour radiofrequency ablation']","['high-flow nasal oxygen', 'HFNO', 'computerised tomography', 'HFNO (oxygen flow 10\u200al\u200amin before sedation and 50\u200al\u200amin during the procedure) or a conventional oxygen face mask (oxygen flow 10\u200al\u200amin) during the procedure', 'High-flow nasal oxygen (HFNO']","['numbers of patients requiring oxygen supplementation', 'area of lung atelectasis calculated on the basis of chest CT images and', 'postprocedural atelectasis']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023903', 'cui_str': 'Neoplasm of liver'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",59.0,0.224667,"The two groups had comparable procedural profiles, but the HFNO group exhibited less postprocedural atelectasis than the face mask group (median [IQR] 7.4 [3.9 to 11.4%] vs. 10.5 [7.2 to 14.6%]; P = 0.0313).","[{'ForeName': 'Chung-Chih', 'Initials': 'CC', 'LastName': 'Shih', 'Affiliation': 'From the Department of Anaesthesiology (C-CS, Y-HC, Y-JH, P-JL, C-YW) and Department of Medical Imaging, National Taiwan University Hospital, Taipei, Taiwan, ROC (P-CL).'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Yueh-Hsun', 'Initials': 'YH', 'LastName': 'Chuang', 'Affiliation': ''}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Pei-Jing', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Wu', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001324']
2091,32890299,Effect of Multimodal Drugs Infiltration on Postoperative Pain in Split Laminectomy of Lumbar Spine: A Randomized Controlled Trial.,"STUDY DESIGN


A randomized, double-blinded controlled trial.
OBJECTIVE


This study tested the effect of single dose wound infiltration with multiple drugs for pain management after lumbar spine surgery.
SUMMARY OF BACKGROUND DATA


Patients undergoing spine surgery often experience severe pain especially in early postoperative period. We hypothesized that intraoperative wound infiltration with multiple drugs would improve outcomes in lumbar spine surgery.
METHODS


Fifty-two patients who underwent 1-2 levels of spinous process splitting laminectomy of lumbar spine, were randomized into two groups. Infiltration group received intraoperative wound infiltration of local anesthetics, morphine sulfate, epinephrine, and nonsteroidal anti-inflammatory drugs at the end of surgery, and received patient controlled analgesia(PCA) postoperatively. The control group received only PCA postoperatively. The primary outcome measures were amount of morphine consumption and visual analogue scale (VAS) for pain. The secondary outcome measures were Oswestry Disability Index(ODI), Roland-Morris Low Back Pain and Disability Questionnaire(RMDQ), patient satisfaction, length of hospital stay, and side effects.
RESULTS


A total of 49 patients (23 patients for local infiltration group, and 26 patients for control group) were analyzed. There were statistically significant [P < 0.001, the effect size -5.0, 95% CI (-6.1, -3.9)] less morphine consumptions in the local infiltration group than the control group during the first 12 hours, 12-24 hours and 24-48 hours after surgery. The VAS of postoperative pain reported by patients at rest and during motion was significantly lower in the local infiltration group than the control group at all assessment times (P < 0.001). The effect size of VAS of postoperative pain at rest and during motion were -2.0, 95% CI (-2.5, -1.4) and -2.0, 95% CI (-2.6, -1.4) respectively. ODI and RMDQ at 2 week and 3 month follow ups, in both groups had significant improvement from baseline (P < 0.001). No significant differences were found between groups (P = 0.262 for ODI and P = 0.296 for RMDQ). There were no significant differences of patient satisfaction, length of stay and side effects between both groups (P = 0.256, P = 0.262, P = 0.145 respectively).
CONCLUSIONS


Intraoperative wound infiltration with multimodal drugs reduced postoperative morphine consumption, decreased pain score with no increased side effects.
LEVEL OF EVIDENCE


1.",2020,"ODI and RMDQ at 2 week and 3 month follow ups, in both groups had significant improvement from baseline (P < 0.001).","['Patients undergoing spine surgery often experience severe pain especially in early postoperative period', 'pain management after lumbar spine surgery', '49 patients (23 patients for local infiltration group, and 26 patients for control group', 'Fifty-two patients who underwent 1-2 levels of spinous process splitting laminectomy of lumbar spine', 'Split Laminectomy of Lumbar Spine']","['intraoperative wound infiltration of local anesthetics, morphine sulfate, epinephrine, and nonsteroidal anti-inflammatory drugs', 'Multimodal Drugs Infiltration']","['ODI and RMDQ', 'postoperative morphine consumption', 'Oswestry Disability Index(ODI', 'patient satisfaction, length of stay and side effects', 'Roland-Morris Low Back Pain and Disability Questionnaire(RMDQ), patient satisfaction, length of hospital stay, and side effects', 'side effects', 'amount of morphine consumption and visual analogue scale (VAS) for pain', 'Postoperative Pain', 'pain score', 'morphine consumptions', 'VAS of postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0582277', 'cui_str': 'Wound infiltration of local anesthetic'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",49.0,0.293146,"ODI and RMDQ at 2 week and 3 month follow ups, in both groups had significant improvement from baseline (P < 0.001).","[{'ForeName': 'Chaiwat', 'Initials': 'C', 'LastName': 'Kraiwattanapong', 'Affiliation': 'Department of Orthopaedics.'}, {'ForeName': 'Vanlapa', 'Initials': 'V', 'LastName': 'Arnuntasupakul', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Rungthiwa', 'Initials': 'R', 'LastName': 'Kantawan', 'Affiliation': 'Department of Nursing, Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Patarawan', 'Initials': 'P', 'LastName': 'Woratanarat', 'Affiliation': 'Department of Orthopaedics.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Keorochana', 'Affiliation': 'Department of Orthopaedics.'}, {'ForeName': 'Nantida', 'Initials': 'N', 'LastName': 'Langsanam', 'Affiliation': 'Department of Nursing, Ramathibodi Hospital, Mahidol University, Thailand.'}]",Spine,['10.1097/BRS.0000000000003679']
2092,32890302,Physical Performance Tests Provide Distinct Information in both Predicting and Assessing Clinical Outcomes Following Lumbar Spine Surgery.,"MINI: This study examined the association between physical performance and patient-reported outcomes at 12-months after lumbar spine surgery. Physical performance tests provided distinct information in both predicting and assessing outcomes in patients undergoing lumbar spine surgery. The 5-Chair Stand test may be a valuable addition to a comprehensive preoperative risk assessment.
STUDY DESIGN


Secondary analysis of randomized controlled trial data.
OBJECTIVE


To examine whether preoperative physical performance is an independent predictor of patient-reported disability and pain at 12-months after lumbar spine surgery.
SUMMARY OF BACKGROUND DATA


Patient-reported outcome measures (PROMs) are commonly used to assess clinical improvement after lumbar spine surgery. However, there is evidence in the orthopedic literature to suggest that PROMs should be supplemented with physical performance tests to accurately evaluate long-term outcomes.
METHODS


248 patients undergoing surgery for degenerative lumbar spine conditions were recruited from two institutions. Physical performance tests (5-Chair Stand and Timed Up and Go) and PROMs of disability (Oswestry Disability Index: ODI) and back and leg pain (Brief Pain Inventory) were assessed preoperatively and at 12-months after surgery.
RESULTS


Physical performance tests and PROMs significantly improved over 12-months following lumbar spine surgery (p < 0.01). Weak correlations were found between physical performance tests and disability and pain (ρ=0.15 to 0.32, p < 0.05). Multivariable regression analyses controlling for age, education, preoperative outcome score, fusion, prior spine surgery, depressive symptoms and randomization group found that preoperative 5-Chair Stand test was significantly associated with disability and back pain at 12-month follow-up. Each additional 10 seconds needed to complete the 5-Chair Stand test was associated with 6-point increase in ODI (p = 0.047) and 1-point increase in back pain (p = 0.028) scores. The physical performance tests identified an additional 14% to 19% of patients as achieving clinical improvement that were not captured by disability or pain questionnaires.
CONCLUSIONS


Results indicate that physical performance tests may provide distinct information in both predicting and assessing clinical outcomes in patients undergoing lumbar spine surgery. Our findings suggest that the 5-Chair Stand test may be a useful test to include within a comprehensive risk assessment before surgery and as an outcome measure at long-term follow-up.
LEVEL OF EVIDENCE


3.",2020,"RESULTS


Physical performance tests and PROMs significantly improved over 12-months following lumbar spine surgery (p < 0.01).","['patients undergoing lumbar spine surgery', 'Lumbar Spine Surgery', '248 patients undergoing surgery for degenerative lumbar spine conditions were recruited from two institutions']",['MINI'],"['disability or pain questionnaires', 'ODI', 'back pain', 'physical performance tests and disability and pain', 'Physical performance tests (5-Chair Stand and Timed Up and Go) and PROMs of disability (Oswestry Disability Index: ODI) and back and leg pain (Brief Pain Inventory', 'disability and back pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408578', 'cui_str': 'Operation on lumbar spine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",248.0,0.113667,"RESULTS


Physical performance tests and PROMs significantly improved over 12-months following lumbar spine surgery (p < 0.01).","[{'ForeName': 'Hiral', 'Initials': 'H', 'LastName': 'Master', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Jacquelyn S', 'Initials': 'JS', 'LastName': 'Pennings', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Rogelio A', 'Initials': 'RA', 'LastName': 'Coronado', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Abigail L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Haug', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Skolasky', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Riley', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Neuman', 'Affiliation': 'Department of Orthopedic Surgery, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Cheng', 'Affiliation': 'Department of Neurological Surgery, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Oran S', 'Initials': 'OS', 'LastName': 'Aaronson', 'Affiliation': 'Howell Allen Clinic, Saint Thomas Medical Partners, Nashville, TN.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Devin', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wegener', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, MD.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Archer', 'Affiliation': 'Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville, TN.'}]",Spine,['10.1097/BRS.0000000000003665']
2093,32890339,Group A emergency release plasma in trauma patients requiring massive transfusion.,"BACKGROUND


Both group A and AB plasma have been approved for emergency release transfusion in acutely bleeding trauma patients prior to blood grouping being performed. The safety profile associated with this practice has not been well characterized, particularly in patients requiring massive transfusion.
METHODS


This secondary analysis of the PROPPR trial examined whether exposure to group A emergency release plasma (ERP) was non-inferior to group AB ERP. We also examined patients whose blood groups were compatible versus incompatible with group A ERP. Outcomes included 30-day mortality and complication rates including systemic inflammatory response syndrome (SIRS), infection, renal injury, pulmonary dysfunction, and thromboembolism.
RESULTS


Of the 680 patients predicted to receive a massive transfusion, 584 (85.9%) received at least 1 unit of ERP. Of the 584 patients analyzed, 462 (79.1%) received group AB and 122 (20.9%) received group A ERP. Using a hazard ratio (HR) of 1.35 as the non-inferiority margin, transfusion with group A versus group AB ERP was not associated with increased thromboembolic rates (HR 0.52, 95% CI 0.31-0.90). Mortality (HR 1.15, 95%CI 0.91-1.45) and non-fatal complication rates (HR 1.24, 95% CI 0.87-1.77) were inconclusive. In the subgroup analysis, transfusion with incompatible ERP (group B or AB patients receiving group A ERP) was not associated with increased nonfatal complications (HR=1.02, 95%CI 0.80-1.30). There were no reported hemolytic transfusion reactions.
CONCLUSION


The use of emergency release plasma is common in patients requiring massive transfusion and facilitates the rapid balanced resuscitation of patients who have sustained blood loss. Group A emergency release plasma is an acceptable option for patients requiring massive transfusion, especially if group AB emergency release plasma is not readily available.Prognostic Level III, Therapeutic / Care Management Level III.",2020,"Mortality (HR 1.15, 95%CI 0.91-1.45) and non-fatal complication rates (HR 1.24, 95% CI 0.87-1.77) were inconclusive.","['trauma patients requiring massive transfusion', 'patients requiring massive transfusion', 'acutely bleeding trauma patients prior to blood grouping being performed', 'patients requiring massive transfusion and facilitates the rapid balanced resuscitation of patients who have sustained blood loss', '680 patients predicted to receive a massive transfusion, 584 (85.9%) received at least 1 unit of ERP']",[],"['Mortality', 'Prognostic Level III, Therapeutic / Care Management Level III', 'nonfatal complications', 'non-fatal complication rates', 'thromboembolic rates', '30-day mortality and complication rates including systemic inflammatory response syndrome (SIRS), infection, renal injury, pulmonary dysfunction, and thromboembolism', 'hemolytic transfusion reactions']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005844', 'cui_str': 'Blood group typing'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0221123', 'cui_str': 'Hemolytic transfusion reaction'}]",680.0,0.0432872,"Mortality (HR 1.15, 95%CI 0.91-1.45) and non-fatal complication rates (HR 1.24, 95% CI 0.87-1.77) were inconclusive.","[{'ForeName': 'Amory', 'Initials': 'A', 'LastName': 'de Roulet', 'Affiliation': ""Division of General Surgery (A.D.), Department of Surgery, New York Presbyterian Queens, Flushing, New York; Division of Trauma (J.D.K.), Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama, Birmingham, Alabama; Division of General Surgery (J.W.), Department of Surgery, Dignity Health Medical Group Arizona, Phoenix, Arizona; Department of Surgery (R.L.), University of Tennesse Health Science Center, Memphis, Tennessee; Department of Pathology, LAC+USC Medical Center (J.H, I.S.), University of Southern California, Los Angeles, California; Center for Translational Injury Research (E.E.F., J.H.), Division of Acute Care Surgery, Department of Surgery, University of Texas Health Science Center, Houston, Texas; Division of Trauma (K.B., M.A.S.), Critical Care and Acute Care Surgery, School of Medicine, Oregon Health and Science University, Portland, Oregon; Division of Trauma and Critical Care (E.M.B.), Department of Surgery, School of Medicine, University of Washington, Seattle, Washington; Department of Surgery (M.C.), University of Colorado, Denver, Colorado; Center for Translational Injury Research (B.A.C.), Division of Acute Care Surgery, Department of Surgery, University of Texas Health Science Center, Houston, Texas; Division of Trauma and Surgical Critical Care (T.C.F.), Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee; Division of Trauma (T.O.), Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, Tucson, Arizona; Trauma and Acute Care Service (S.B.R.), St. Michael's Hospital, Toronto, Ontario, Canada; R Adams Crowley Shock Trauma Center (T.S.), University of Maryland, Baltimore, Maryland; and Division of Trauma and Critical Care (K.I.), LAC+USC Medical Center, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kerby', 'Affiliation': ''}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Weinberg', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hudgins', 'Affiliation': ''}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Shulman', 'Affiliation': ''}, {'ForeName': 'Erin Elizabeth', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Brasel', 'Affiliation': ''}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bulger', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Cotton', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fabian', 'Affiliation': ''}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': ""O'Keeffe"", 'Affiliation': ''}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Rizoli', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Scalea', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Inaba', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002903']
2094,32890429,A feasibility randomised controlled trial of a fibromyalgia self-management programme in a community setting with a nested qualitative study (FALCON): Study protocol.,"BACKGROUND


Fibromyalgia (FM) is a complex long-term condition associated with chronic widespread pain, fatigue, sleep problems, memory and concentration difficulties and irritable bowel syndrome. Current guidelines for the treatment of FM recommend nonpharmacological interventions. The Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary exercise and education group intervention. It aims to provide education and teach core skills, enabling those affected by FM to self-manage. The FSMP is currently codelivered by a multidisciplinary team within a secondary care service. The aim of this feasibility randomised controlled trial (RCT) is to determine the practicality and acceptability of delivering the FSMP in a community setting, informing a future RCT of effectiveness.
METHODS


The feasibility RCT aims to recruit 70 people with FM. Participants will be randomised to either a community FSMP or control arm. All participants will be asked to complete six patient-reported outcome measures and one health economics questionnaire on three occasions; baseline, 6 weeks (end of the intervention) and 6 months. Between 12 and 16 participants and four therapists delivering the FSMP will be invited to take part in a semi-structured interview to explore their experiences of the FSMP. Patient participants will be purposively selected based upon key characteristics.
ANALYSIS


Quantitative data will be analysed descriptively to summarise recruitment and attendance, participant reported outcomes and health economic data. Semi-structured interviews will be transcribed, anonymised and inductively coded. The codes will be grouped into categories and theoretically thematically analysed, comparing the results to existing literature.
TRIAL REGISTRATION


The trial is registered with ISRCTN registry and was assigned on 29th of April 2020. The registration number is ISRCTN10824225.",2020,"The Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary exercise and education group intervention.","['Between 12 and 16 participants and four therapists delivering the', 'Patient participants will be purposively selected based upon key characteristics', '70 people with FM']","['FSMP', 'community FSMP or control arm', 'fibromyalgia self-management programme']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",[],,0.16908,"The Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary exercise and education group intervention.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pearson', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, Bristol, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coggins', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, Bristol, UK.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lenguerrand', 'Affiliation': 'Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sandi', 'Initials': 'S', 'LastName': 'Derham', 'Affiliation': 'Therapy Department, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Russell', 'Affiliation': 'Therapy Department, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'Nicola E', 'Initials': 'NE', 'LastName': 'Walsh', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, Bristol, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cramp', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, Bristol, UK.'}]",Musculoskeletal care,['10.1002/msc.1509']
2095,32890444,Methylene blue vs. methyl aminolevulinate photodynamic therapy in the treatment of mild-to-moderate toenail onychomycosis: short and medium-term effects.,"Photodynamic therapy (PDT) has emerged as an interesting alternative option for onychomycosis treatment. The impact of a specific photosensitizer (PS) on the final result is an important factor to consider. We conducted a short- and medium-term controlled trial to compare the effectiveness of PDT in the treatment of mild-to-moderate onychomycosis when it is mediated by two different PSs. Twenty patients were randomized to receive 9 sessions of PDT distributed over 16 weeks mediated either by methylene blue (MB/PDT group) or methyl aminolevulinate (MAL/PDT group). Onychomycosis severity index (OSI) and nail involvement were checked along the study. Complete cure, treatment success and clinical improvement were tabulated at 16 and 40-week follow-ups. OSI scores decreased significantly along the study, from 12.1±5.4 to 3.6±3.2 (MB/PDT group) and from 14.8±6.0 to 5.4±4.4 (MAL/PDT group). At 16-week follow-up, only 20% of the patients in the MB/PDT group reached complete cure and none in the group of MAL/PDT. At 40-week follow-up, complete cure rates were 70% and 40% in the MB/PDT group and MAL/PDT group respectively. Both modalities showed good outcomes in treatment of moderate toenail onychomycosis. MB/PDT showed a faster action but with relapse rates slightly higher than MAL/PDT. This article is protected by copyright. All rights reserved.",2020,"At 40-week follow-up, complete cure rates were 70% and 40% in the MB/PDT group and MAL/PDT group respectively.","['Twenty patients', 'mild-to-moderate toenail onychomycosis']","['Photodynamic therapy (PDT', 'MB/PDT', 'Methylene blue vs. methyl aminolevulinate photodynamic therapy', 'PDT distributed over 16\u2009weeks mediated either by methylene blue (MB/PDT group) or methyl aminolevulinate (MAL/PDT', 'specific photosensitizer (PS', 'PDT']","['Complete cure, treatment success and clinical improvement', 'complete cure rates', 'complete cure', 'Onychomycosis severity index (OSI) and nail involvement', 'OSI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C1134467', 'cui_str': 'methyl 5-aminolevulinate'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024551', 'cui_str': 'Malayalam language'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0162713', 'cui_str': 'Photosensitizing agent'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0220669,"At 40-week follow-up, complete cure rates were 70% and 40% in the MB/PDT group and MAL/PDT group respectively.","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alberdi', 'Affiliation': 'Private clinic of Dr. Alberdi, Aviador Zorita 25, Madrid.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Institute of Physical Chemistry Rocasolano, CSIC, Serrano 119, Madrid, Spain.'}]",Dermatologic therapy,['10.1111/dth.14280']
2096,32890472,Do Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy Minimize Postoperative Pain and Edema After Molar Extraction?,"INTRODUCTION


Control of postoperative symptoms after molar extractions positively impacts patient comfort.
PURPOSE


This study was designed to examine the efficacy of antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT) in reducing postoperative pain and edema after molar extractions.
METHODS


The investigators designed a single-blind randomized controlled study and enrolled subjects requiring extraction of at least one of the first or second molars. They were randomized to one of the following four groups: control group, aPDT group, LLLT group, and aPDT and LLLT group. Patients were blinded to the group assigned. The outcome variables were postoperative pain and edema. Pain intensity was measured on a visual analog scale (recorded every day for 7 days after tooth extraction). Facial edema was assessed by measuring the perimeter between the tragus, base of the jaw, and labial commissure, which was recorded once before surgery and then on the third and seventh days after surgery. Other variables were age, sex, ethnicity, decayed/missing/filled teeth, and tooth types. Appropriate univariate and bivariate statistics were computed and statistical significance was set at a value of P < .05.
RESULTS


The sample was composed of 40 patients with a mean age of 41.25 ± 13.97 years and 25 (62.5%) of them were women. There were 10 subjects in each treatment group. The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05). Postoperative pain was lowest in the aPDT + LLLT group in the 1st, 2nd, 3rd, 5th, 6th, and 7th day after tooth extraction (P < .05). There were no significant differences in edema among the groups (P > .05).
CONCLUSION


The combined use of aPDT and LLLT was effective in reducing postoperative pain. These procedures can be applied in everyday surgical practice.",2020,The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05).,"['40 patients with a mean age of 41.25\xa0±\xa013.97 years and 25 (62.5%) of them were women', 'enrolled subjects requiring extraction of at least one of the first or second\xa0molars']","['antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT', 'aPDT\xa0+\xa0LLLT', 'aPDT and LLLT', 'control group, aPDT group, LLLT', 'Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy']","['visual analog scale', 'edema', 'mean of postoperative pain', 'postoperative pain and edema', 'postoperative pain', 'Pain intensity', 'Postoperative pain', 'Facial edema', 'Postoperative Pain and Edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}]",40.0,0.0341872,The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05).,"[{'ForeName': 'Renato Silva', 'Initials': 'RS', 'LastName': 'Fraga', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil, Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil.'}, {'ForeName': 'Lívia Azeredo', 'Initials': 'LA', 'LastName': 'Alves Antunes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil; Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil.'}, {'ForeName': 'Walter Luis', 'Initials': 'WL', 'LastName': 'Soares Fialho', 'Affiliation': 'Professor, School of Medicine, Petropolis University, Petrópolis, RJ, Brazil.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Valente', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Cinthya Cristina', 'Initials': 'CC', 'LastName': 'Gomes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Karla Bianca', 'Initials': 'KB', 'LastName': 'Fontes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Leonardo Santos', 'Initials': 'LS', 'LastName': 'Antunes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil; Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil. Electronic address: leonardoantunes@id.uff.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.002']
2097,32890574,Randomized trial of early infant formula introduction to prevent cow's milk allergy.,"BACKGROUND


Previous research has produced conflicting evidence on the preventative effects of early cow's milk protein introduction on cow's milk allergy (CMA).
OBJECTIVE


Through a randomized controlled trial, we sought to determine whether the early introduction of cow's milk formula (CMF) could serve as an effective strategy in the primary prevention of CMA in a general population.
METHODS


We recruited newborns from 4 hospitals in Okinawa, Japan. Participants were randomly allocated to ingest ≥10 mL of CMF daily (ingestion group) or avoid CMF (avoidance group) between 1 and 2 months of age. The avoidance group supplemented breastfeeding with soy formula as needed. An oral food challenge was performed at 6 months of age to assess CMA development. Continuous breastfeeding was recommended for both groups until 6 months of age.
RESULTS


We identified 504 infants for randomization into the 2 groups. Twelve participants declined to receive the intervention, and the study sample comprised 491 participants (ingestion group: 242; avoidance group: 249) for a modified intention-to-treat analysis. The number of CMA cases was 2 (0.8%) of 242 in the ingestion group and 17 (6.8%) of 249 in the avoidance group (risk ratio: 0.12; 95% confidence interval: 0.01-0.50; P<.001). The risk difference was 6.0% (95% confidence interval: 2.7-9.3). Approximately 70% of participants received breastfeeding at 6 months of age in both groups.
CONCLUSIONS


Daily ingestion of CMF between 1 and 2 months of age prevents CMA development. This strategy does not compete with breastfeeding.",2020,The number of CMA cases was 2 (0.8%) of 242 in the ingestion group and 17 (6.8%) of 249 in the avoidance group (risk ratio: 0.12; 95% confidence interval: 0.01-0.50; P<.001).,"['504 infants for randomization into the 2 groups', 'Twelve participants declined to receive the intervention, and the study sample comprised 491 participants (ingestion group: 242', ""cow's milk allergy (CMA"", ""cow's milk allergy"", 'recruited newborns from 4 hospitals in Okinawa, Japan']","[""cow's milk formula (CMF"", 'avoidance group supplemented breastfeeding with soy formula', 'avoidance group: 249) for a modified intention-to-treat analysis', 'ingest ≥10 mL of CMF daily (ingestion group) or avoid CMF (avoidance group']",['number of CMA cases'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454748', 'cui_str': 'Okinawa'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0868928', 'cui_str': 'Case'}]",504.0,0.211029,The number of CMA cases was 2 (0.8%) of 242 in the ingestion group and 17 (6.8%) of 249 in the avoidance group (risk ratio: 0.12; 95% confidence interval: 0.01-0.50; P<.001).,"[{'ForeName': 'Tetsuhiro', 'Initials': 'T', 'LastName': 'Sakihara', 'Affiliation': 'Department of Pediatrics, Heartlife Hospital, Okinawa, Japan. Electronic address: odekorin2000@yahoo.co.jp.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Otsuji', 'Affiliation': 'Department of Pediatrics, Okinawa Kyodo Hospital, Okinawa, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Arakaki', 'Affiliation': 'Department of Pediatrics, Naha City Hospital, Okinawa, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Hamada', 'Affiliation': 'Department of Child Health and Welfare (Pediatrics), Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Sugiura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Komei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.08.021']
2098,32888452,"Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND


Venetoclax plus obinutuzumab has been established as a fixed-duration treatment regimen for patients with chronic lymphocytic leukaemia. We compared the long-term efficacy after treatment cessation of the combination of venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia.
METHODS


CLL14 is a multicentre, randomised, open-label, phase 3 trial done at 196 sites in 21 countries. Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both. Patients were randomly assigned (1:1) via a web and voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region. Patients received either venetoclax plus obinutuzumab (oral venetoclax initiated on day 22 of cycle 1 [28-day cycles], with a 5-week dose ramp-up [20 mg, 50 mg, 100 mg, and 200 mg, then 400 mg daily for 1 week], thereafter continuing at 400 mg daily until completion of cycle 12; combined with intravenous obinutuzumab for six cycles starting with 100 mg on day 1 and 900 mg on day 2 [or 1000 mg on day 1], 1000 mg on days 8 and day 15 of cycle 1, and subsequently 1000 mg on day 1 of cycles 2 through 6) or chlorambucil plus obinutuzumab (oral chlorambucil at 0·5 mg/kg bodyweight on days 1 and 15 of each cycle for 12 cycles combined with the same obinutuzumab regimen). The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. Patient enrolment is complete, and the study is registered with ClinicalTrails.gov, NCT02242942.
FINDINGS


Between Aug 7, 2015, and Aug 4, 2016, 432 patients were enrolled and randomly assigned to receive either venetoclax plus obinutuzumab (n=216) or chlorambucil plus obinutuzumab (n=216). All patients had been off treatment for at least 24 months at data collection. At a median follow-up of 39·6 months (IQR 36·8-43·0), patients given venetoclax plus obinutuzumab had a significantly longer progression-free survival than did patients given chlorambucil plus obinutuzumab (HR 0·31, 95% CI 0·22-0·44; p<0·0001). Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group. The most common grade 3 or 4 adverse event in both groups was neutropenia (112 [53%] of 212 patients in the venetoclax plus obinutuzumab group versus 102 [48%] of 214 patients in the chlorambucil plus obinutuzumab group). Serious adverse events occurred in 115 (54%) of 212 patients in the venetoclax plus obinutuzumab group and 95 (44%) of 214 patients in the chlorambucil plus obinutuzumab group. Venetoclax or chlorambucil treatment-related deaths were reported in one (1%) of 212 patients in the venetoclax plus obinutuzumab group (n=1 sepsis) and two (1%) of 214 patients in the chlorambucil plus obinutuzumab group (n=1 septic shock, n=1 metastatic skin squamous carcinoma).
INTERPRETATION


2 years after treatment cessation, venetoclax plus obinutuzumab continues to significantly improve progression-survival compared with chlorambucil plus obinutuzumab, thereby providing a limited duration treatment option for patients with previously untreated chronic lymphocytic leukaemia.
FUNDING


F Hoffmann-La Roche and AbbVie.",2020,Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group.,"['previously untreated chronic lymphocytic leukaemia (CLL14', 'patients with previously untreated chronic lymphocytic leukaemia', 'Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both', 'patients with chronic lymphocytic leukaemia', '196 sites in 21 countries', 'Between Aug 7, 2015, and Aug 4, 2016, 432 patients', '212 patients in the venetoclax plus obinutuzumab group (n=1 sepsis) and two (1%) of 214 patients in the chlorambucil plus obinutuzumab group (n=1 septic shock, n=1 metastatic skin squamous carcinoma']","['venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab', 'venetoclax plus obinutuzumab (oral venetoclax', 'Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab', 'chlorambucil plus obinutuzumab', 'intravenous obinutuzumab', 'Venetoclax or chlorambucil', 'venetoclax plus obinutuzumab', 'chlorambucil plus obinutuzumab (oral chlorambucil', 'voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region']","['Safety', 'longer progression-free survival', 'Serious adverse events', 'investigator-assessed progression-free survival', 'neutropenia', 'progression-survival', 'Median progression-free survival']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",432.0,0.282151,Median progression-free survival was not reached (95% CI not estimable to not estimable) in the venetoclax plus obinutuzumab group vs 35·6 months (33·7-40·7) in the chlorambucil plus obinutuzumab group.,"[{'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Maneesh', 'Initials': 'M', 'LastName': 'Tandon', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoylova', 'Affiliation': 'Regional Clinical Hospital NA Semashko, Nizhny Novgorod, Russia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Liberati', 'Affiliation': 'Division of Onco-Hematology, Santa Maria Terni Hospital, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pinilla-Ibarz', 'Affiliation': 'Department of Malignant Hematology, H Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Opat', 'Affiliation': 'Haematology Department, School of Clinical Sciences at Monash Health, Monash University, VIC, Australia.'}, {'ForeName': 'Liliya', 'Initials': 'L', 'LastName': 'Sivcheva', 'Affiliation': 'First Internal Department, MHAT Hristo Botev, AD, Vratsa, Bulgaria.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': 'Le Dû', 'Affiliation': 'Hematology Department, Clinique Le Mans, France.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carsten U', 'Initials': 'CU', 'LastName': 'Niemann', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Weinkove', 'Affiliation': 'Wellington Blood and Cancer Centre, Capital and Coast District Health Board and Malaghan Institute of Medical Research, Wellington, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Queen Elizabeth II Health Science Center, Halifax, NS, Canada.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Eugen', 'Initials': 'E', 'LastName': 'Tausch', 'Affiliation': 'Department III of Internal Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Schary', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ritgen', 'Affiliation': 'Department II of Internal Medicine, Campus Kiel, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wendtner', 'Affiliation': 'Department of Hematology, Oncology, Immunology, Palliative Care, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany. Electronic address: michael.hallek@uk-koeln.de.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Cologne Aachen Cologne Bonn Duesseldorf, German CLL Study Group, University Hospital, University of Cologne, Germany.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30443-5']
2099,32889324,Predict overall survival of spinal conventional chordoma: Development and assessment of a new predictive nomogram.,"OBJECTIVE


To predict the 5-year overall survival (OS) rate in patients with conventional chordoma of the spine PATIENTS AND METHODS: The Surveillance, Epidemiology, and End Results (SEER) Registry was used to identify patients with conventional chordoma of the spine from 1994 to 2013. The entire cohort(n = 294) was randomly divided into training (n = 147) and validation (n = 147) cohorts to construct a nomogram. We used the univariate Log-rank test and multivariate Cox model to examine the independent prognostic factors associated with OS. These prognostic factors were integrated to construct a nomogram through R studio. The predictive and validating capacity of the nomogram was calculated by Harrell's concordance index (C-index) and calibration curves.
RESULTS


A total of 294 patients were identified with conventional chordoma of the spine. The patients' age at diagnosis, tumor size, EOD (extent of disease), and treatment were independent prognostic factors and associated with OS. These prognostic factors were incorporated to construct a nomogram. The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively. Internal and external calibration curves for 5-year OS showed excellent matching between nomogram prediction and observed outcomes.
CONCLUSIONS


The findings of this study provide population-based estimates of patients with conventional chordoma of the spine. Using this nomogram, surgeons can classify patients into different risk groups and achieve individualized treatment.",2020,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","['patients with conventional chordoma of the spine', 'patients with conventional chordoma of the spine from 1994 to 2013', '294 patients were identified with conventional chordoma of the spine']",[],"['Surveillance, Epidemiology, and End Results (SEER', '5-year overall survival (OS) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008487', 'cui_str': 'Chordoma'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",294.0,0.0249893,"The concordance index for the nomogram was 0.771 and 0.732 in the training cohort and validation cohort, respectively.","[{'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopedic Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Kehan', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shengxing', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Libo', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Huiren', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wang.huiren@zs-hospital.sh.cn.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: dong.jian@zs-hospital.sh.cn.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106174']
2100,32889781,Oral contraceptives and menstrual cycle influence autonomic reflex function.,"Progesterone and its analogues are known to influence ventilation. Therefore, the purpose of this study was to investigate the role of endogenous and pharmaceutical female sex hormones in ventilatory control during the activation of the metaboreflex, mechanoreflex, and CO 2  chemoreflex. Women aged 18-30 taking (n = 14) or not taking (n = 12) oral contraceptives (OC and NOC, respectively) were tested in the low hormone (LH) and high hormone (HH) conditions corresponding to the early follicular and mid-luteal phases (NOC) or placebo and high-dose pills (OC). Women underwent three randomized trials: (a) 3 min of passive leg movement (PLM), (b) 2 min of 40% maximal voluntary handgrip exercise followed by 2 min of post-exercise circulatory occlusion (PECO), and (c) 5 min of breathing 5% CO 2  . We primarily measured hemodynamics and ventilation. During PLM, the OC group had a smaller pressor response (p = .012). During PECO, the OC group similarly exhibited a smaller pressor response (p = .043) and also exhibited a greater ventilatory response (p = .024). Lastly, in response to breathing 5% CO 2  , women in the HH phase had a greater ventilatory response (p = .022). We found that OC use attenuates the pressor response to both the metaboreflex and mechanoreflex while increasing the ventilatory response to metaboreflex activation. We also found evidence of an enhanced CO 2  chemoreflex in the HH phase. We hypothesize that OC effects are from the chronic upregulation of pulmonary and vascular β-adrenergic receptors. We further suggest that the increased cyclic progesterone in the HH phase enhances the chemoreflex.",2020,"During PECO, the OC group similarly exhibited a smaller pressor response (p = .043) and also exhibited a greater ventilatory response (p = .024).","['Women aged 18-30 taking (n\xa0=\xa014) or not taking (n\xa0=\xa012) oral contraceptives (OC and NOC, respectively) were tested in the low hormone (LH) and high hormone (HH) conditions corresponding to the early follicular and mid-luteal phases (NOC) or']","['40% maximal voluntary handgrip exercise followed by 2\xa0min of post-exercise circulatory occlusion (PECO), and (c) 5\xa0min of breathing 5% CO 2  ', 'OC', 'Progesterone', 'placebo and high-dose pills (OC', '3\xa0min of passive leg movement (PLM']","['Oral contraceptives and menstrual cycle influence autonomic reflex function', 'ventilatory response', 'smaller pressor response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",,0.0281907,"During PECO, the OC group similarly exhibited a smaller pressor response (p = .043) and also exhibited a greater ventilatory response (p = .024).","[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Assadpour', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Ivry', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wasef', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Baithat', 'Initials': 'B', 'LastName': 'Adeyinka', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Murray', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Edgell', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON, Canada.'}]",Physiological reports,['10.14814/phy2.14550']
2101,32886650,Assessing the validity and reliability and determining cut-points of the Actiwatch 2 in measuring physical activity.,"OBJECTIVE


The Actiwatch 2 (AW2) is a wrist-worn accelerometer typically used to measure sleep. Although it can measure physical activity, there is limited evidence supporting its validity. We assessed the validity and reliability of the AW2 to measure sedentary behavior and physical activity (light, moderate, vigorous intensities), and reported their respective count cut-points.
APPROACH


Twenty-eight males and 22 females completed a task battery comprising three sedentary tasks and six randomized physical activity tasks at varying intensities, whilst wearing the AW2, a reference accelerometry device (Actigraph GT3X) and a cardiopulmonary gas analyzer on two separate occasions. Validity was assessed using correlations (AW2 counts versus GT3X counts and metabolic equivalent (MET) values), reliability using Bland-Altman analyses, and cut-points were determined using receiver operating characteristic (ROC) area under the curve (AUC) analyses.
MAIN RESULTS


AW2 counts were positively correlated with GT3X counts (rho = 0.902, p < 0.001) and METs (rho = 0.900, p < 0.001). AW2-derived counts were comparable across independent assessment periods. Sedentary (AUC = 0.99, cut-point: 256 cpm) and vigorous activity (AUC = 0.95, cut-point: 720 cpm) were strongly characterized, and moderate activity (AUC = 0.66, cut-point: 418 cpm) was weakly characterized.
SIGNIFICANCE


The use of the AW2 in physical activity monitoring looks promising for sedentary behavior, moderate and vigorous activity, however, further validation is needed.",2020,"MAIN RESULTS


AW2 counts were positively correlated with GT3X counts (rho = 0.902, p < 0.001) and METs (rho = 0.900, p < 0.001).",['Twenty-eight males and 22 females completed a'],"['task battery comprising three sedentary tasks and six randomized physical activity tasks at varying intensities, whilst wearing the AW2, a reference accelerometry device (Actigraph GT3X']","['validity and reliability of the AW2 to measure sedentary behavior and physical activity (light, moderate, vigorous intensities', 'correlations (AW2 counts versus GT3X counts and metabolic equivalent (MET) values), reliability using Bland-Altman analyses, and cut-points', 'receiver operating characteristic (ROC) area under the curve (AUC) analyses', 'AW2-derived counts', 'GT3X counts']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0035036', 'cui_str': 'Reliability and Validity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",3.0,0.0213622,"MAIN RESULTS


AW2 counts were positively correlated with GT3X counts (rho = 0.902, p < 0.001) and METs (rho = 0.900, p < 0.001).","[{'ForeName': 'Chadley', 'Initials': 'C', 'LastName': 'Kemp', 'Affiliation': 'Health through Physical Activity, Lifestyle and Sport Research Centre & Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, South Africa.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Pienaar', 'Affiliation': ''}, {'ForeName': 'Rob H P', 'Initials': 'RHP', 'LastName': 'Henst', 'Affiliation': ''}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Roden', 'Affiliation': ''}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Kolbe-Alexander', 'Affiliation': ''}, {'ForeName': 'Dale E', 'Initials': 'DE', 'LastName': 'Rae', 'Affiliation': ''}]",Physiological measurement,['10.1088/1361-6579/aba80f']
2102,32886710,Study of the efficacy of the Hero program: Cross-national evidence.,"The present study focuses on an analysis of the efficacy of the online intervention program called ""Hero"" for promoting prosociality and other socioemotional variables related to prosocial behavior, such as empathy, positive emotions, and forgiveness, in two Latin American countries: Argentina and Uruguay. The final Argentinean sample consisted of 579 adolescents (experimental group = 319 and control group = 260), and the Uruguayan sample consisted of 330 adolescents (experimental group = 140 and control group = 169), aged 12 to 15 years old. The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness. It impacted each of the dimensions comprising these variables differently depending on the country where it was applied. We discuss the differences found in each country.",2020,"The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness.","['579 adolescents (experimental group = 319 and control group = 260), and the Uruguayan sample consisted of 330 adolescents (experimental group = 140 and control group = 169), aged 12 to 15 years old']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],579.0,0.016216,"The 'Hero' program provided evidence of efficacy for the promotion of prosociality, empathy, positive emotions, and attitudes of forgiveness.","[{'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Mesurado', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Oñate', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Rodriguez', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Putrino', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Guerra', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Vanney', 'Affiliation': 'Universidad Austral, Pilar, Argentina.'}]",PloS one,['10.1371/journal.pone.0238442']
2103,32886727,"Assessing the impact of professional lactation support frequency, duration and delivery form on exclusive breastfeeding in Lebanese mothers.","BACKGROUND


The optimal frequency, duration, and form of professional lactation support needed to continue exclusive breastfeeding (EBF) for six months have not yet been specifically identified. This study investigates the association between six-month EBF and the frequency, duration, and form (face-to-face vs. telephone contact) of professional lactation support in a cohort of Lebanese mothers, and explores barriers to EBF during the first six months postpartum.
METHODS


An observational study was nested in a breastfeeding support randomized controlled trial. Secondary analysis of data from 159 trial participants who received professional lactation support was conducted. (1) Six-month EBF with professional lactation support frequency, duration, and form was investigated using bivariate and multivariate regression analyses. (2) Barriers to breastfeeding were explored using content analysis of narrative data collected about breastfeeding mothers by the lactation experts.
RESULTS


Six-month EBF was achieved by 57/159 (35.8%) participants. Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001). In crude analysis, those mothers had a higher number of overall contacts with lactation experts (mean ± SD of 9.5 ± 2.9 vs. 7.0 ± 4.4, p = 0.001), and longer duration of face-to-face contacts (mean ± SD of 261.9 ± 209.1 vs. 201.0 ± 117.4 minutes, p = 0.035). In adjusted analysis, frequencies of overall and of telephone contacts with the lactation experts were positively associated with six-month EBF (OR = 1.15; 95% CI: 1.04 to 1.27, p = 0.007; OR = 1.12; 95% CI: 1.00 to 1.26, p = 0.05; respectively). Participants discontinuing EBF early were described as inexperienced, lacking breastfeeding knowledge, concerned about milk insufficiency, and showing negative attitudes towards night feeds.
CONCLUSION


Need-based telephone contact augmenting face-to-face professional lactation support may positively influence six-month EBF. Early identification of mothers at risk for early discontinuation of EBF can help tailor interventions specific to their concerns.",2020,"Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001).","['159 trial participants who received professional lactation support was conducted', 'Lebanese mothers']",['EBF'],[],"[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",[],,0.0567391,"Professional lactation support was received by more mothers continuing six months of EBF (100% vs. 83.3%, p = 0.001).","[{'ForeName': 'Dayane', 'Initials': 'D', 'LastName': 'Daou', 'Affiliation': 'Department of Anesthesiology, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Tamim', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine, Clinical Research Institute, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nabulsi', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, American University of Beirut, Beirut, Lebanon.'}]",PloS one,['10.1371/journal.pone.0238735']
2104,32890076,"Is Cooled Radiofrequency Ablation the Hot New Treatment for Knee Osteoarthritis?: Commentary on an article by Antonia F. Chen, MD, MBA, et al.: ""Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain. A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation"".",,2020,,[],"['Hyaluronic Acid', 'Cooled Radiofrequency Ablation']",[],[],"[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]",[],,0.0323513,,"[{'ForeName': 'Gregory B', 'Initials': 'GB', 'LastName': 'Maletis', 'Affiliation': 'Department of Orthopedics, Kaiser Permanente Baldwin Park, Baldwin Park, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.01209']
2105,32890282,Visit-to-visit blood pressure variability and renal outcomes: results from ONTARGET and TRANSCEND trials.,"AIMS


There is conflicting evidence on whether in treated hypertensive patients the risk of renal outcomes is associated with visit-to-visit SBP variability. Furthermore, limited evidence is available on how important is SBP variability for prediction of renal outcomes compared with on-treatment mean SBP. We addressed these issues in 28 790 participants of the Ongoing Treatment Alone and in combination with Ramipril Global End point Trial and Telmisartan Randomized AssessmeNt Study in ACE iNtolerant Subjects with Cardiovascular Disease trials.
METHODS AND RESULTS


SBP variability was expressed as the coefficient of variation of the mean with which it showed no relationship. SBP variability and mean values were obtained from five visits during the first 2 years of treatment after the end of the titration phase. Incidence of several renal outcomes (end-stage renal disease, doubling of serum creatinine, new microalbuminuria, new macroalbuminuria and their composite) was calculated from the third year of treatment onward. Patients were divided in quintiles of SBP-coefficient of variation (SBP-CV) or mean SBP, which exhibited superimposable mean blood pressure and SBP-CV values, respectively. A progressive increase of SBP-CV was not accompanied by a parallel increase in a widely adjusted (baseline and on-treatment confounders) risk of most renal outcomes (end-stage renal disease, new macroalbuminuria, new microalbuminuria and their composite) in the subsequent on-treatment years. In contrast, the adjusted risk of most renal outcomes increased progressively from the lowest to the highest quintile of on-treatment mean SBP. Progression from lowest to highest mean on-treatment SBP, but not SBP-CV, was also associated with a less frequent return to normoalbuminuria in patients with initial micro or macroalbuminuria. Renal outcome prediction was slightly improved by the combined use of SBP-CV and mean SBP quintiles.
CONCLUSION


Visit-to-visit SBP variability had no major predictive value for the risk of renal outcomes, which, in contrast, was sensitively predicted by mean on-treatment SBP. A further slight increase in prediction of renal outcomes was seen by combining on-treatment mean SBP and variability.",2020,"Incidence of several renal outcomes (end-stage renal disease, doubling of serum creatinine, new microalbuminuria, new macroalbuminuria and their composite) was calculated from the third year of treatment onward.",['28\u200a790 participants of the Ongoing Treatment Alone and in combination with Ramipril Global End point Trial and Telmisartan Randomized AssessmeNt Study in ACE iNtolerant Subjects with Cardiovascular Disease trials'],[],"['adjusted risk of most renal outcomes', 'SBP-CV', 'Incidence of several renal outcomes (end-stage renal disease, doubling of serum creatinine, new microalbuminuria, new macroalbuminuria and their composite', 'SBP-CV and mean SBP quintiles', 'SBP-coefficient of variation (SBP-CV) or mean SBP', 'Visit-to-visit blood pressure variability and renal outcomes', 'SBP variability and mean values', 'prediction of renal outcomes']","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",[],"[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0179591,"Incidence of several renal outcomes (end-stage renal disease, doubling of serum creatinine, new microalbuminuria, new macroalbuminuria and their composite) was calculated from the third year of treatment onward.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'University of Milano-Bicocca, Milan.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schumacher', 'Affiliation': 'Statistical Consultant, Ingelheim.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III, Saarland University, Saarbrücken.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'KfH Kidney Center and Friedrich Alexander University, Erlangen, Germany.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Redon', 'Affiliation': 'Incliva Research Institute, University of Valencia and CIBEROBn, Carlos III Institute, Madrid, Spain.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Facchetti', 'Affiliation': 'Dipartimento di Medicina e Chirurgia, Università Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Roland E', 'Initials': 'RE', 'LastName': 'Schmieder', 'Affiliation': 'Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Lonn', 'Affiliation': 'Population Health Research Institute, Hamilton Health Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Koon K', 'Initials': 'KK', 'LastName': 'Teo', 'Affiliation': 'Population Health Research Institute, Hamilton Health Science, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Population Health Research Institute, Hamilton Health Science, McMaster University, Hamilton, Ontario, Canada.'}]",Journal of hypertension,['10.1097/HJH.0000000000002567']
2106,32890813,CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine + sorafenib/placebo in patients with R1 resection of pancreatic cancer - Final results.,"BACKGROUND


CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles.
PATIENTS AND METHODS


This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment.
RESULTS


122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
CONCLUSION


CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients.
CLINICAL TRIAL INFORMATION


German Tumor Study Registry (Deutsches Krebsstudienregister), DRKS00000242.",2020,"Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
","['patients with R1 resection of pancreatic cancer - Final results', '122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP', 'German Tumor Study Registry', 'patients with pancreatic adenocarcinoma with postsurgical R1 residual status']","['gemcitabine + sorafenib/placebo', 'gemcitabine\xa0+\xa0placebo (GemP', 'gemcitabine and sorafenib (GemSorafenib', 'Sorafenib', 'placebo', 'gemcitabine']","['recurrence-free survival (RFS', 'thrombocytopenia', 'hypertension', 'RFS nor OS', 'survival', 'fatigue', 'RFS (median GemSorafenib', 'neutropenia', 'longer OS', 'nodal positivity', 'overall survival (OS), safety and duration of treatment', 'Grade 3/4 toxicities comprised diarrhoea', 'elevated gamma-glutamyl transferase (GGT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}]",122.0,0.424538,"Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021).
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany; Universitätsklinikum Hamburg-Eppendorf, Department of Medical Oncology, Hamburg, Germany. Electronic address: ma.sinn@uke.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Liersch', 'Affiliation': 'University of Göttingen, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gellert', 'Affiliation': 'Sana Klinikum Lichtenberg, Department of General and Visceral Surgery, Berlin, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stübs', 'Affiliation': 'Otto-Guericke-University of Magdeburg, Department of General, Visceral and Vascular Surgery, Magdeburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Waldschmidt', 'Affiliation': 'University of Köln, Department of Gastroenterology and Hepatology, Köln, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lammert', 'Affiliation': 'Universitätskliniken des Saarlandes, Department of Internal Medicine, Gastroenterology and Endocrinology, Homburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Maschmeyer', 'Affiliation': 'Ernst von Bergmann Klinikum, Department of Hematology, Oncology and Palliative Care, Potsdam, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bechstein', 'Affiliation': 'Universitätsklinikum Frankfurt, Department of General and Visceral Surgery, Frankfurt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bitzer', 'Affiliation': 'Eberhard-Karls-Universität Tübingen, Department of Internal Medicine, Tübingen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital Stuttgart, Department of Hematology, Oncology and Palliative Care, Stuttgart Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hofheinz', 'Affiliation': 'Universitätsklinikum Mannheim, Department of Medical Oncology, Mannheim, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Lindig', 'Affiliation': 'Universitätsklinikum Jena, Department of Hematology and Oncology, Jena, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'University of Göttingen, Department of General, Visceral and Pediatric Surgery, Göttingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hinke', 'Affiliation': 'CCRC, Düsseldorf, Germany.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Striefler', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Pelzer', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bischoff', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Medical Oncology and Hematology, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bahra', 'Affiliation': 'Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Surgery, Berlin, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oettle', 'Affiliation': 'Outpatient Department of Hematology/Oncology, Friedrichshafen, Germany.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.032']
2107,32890969,Effect of high-intensity interval training on cardiac structure and function in rats with acute myocardial infarct.,"BACKGROUND


Exercise training is beneficial for cardiac rehabilitation. Nevertheless, few study focused on the role of high-intensity interval training (HIIT) in cardiac repair. The current study aimed to elucidate the effect of HIIT on cardiac rehabilitation and the involved mechanisms after acute myocardial infarction (MI).
METHODS


A total of 65 male rats underwent coronary ligation or sham operation and were randomly assigned to 4 groups: sham (n = 10), sedentary (MI-Sed, n = 12), moderate-intensity continuous training (MI-MCT, n = 12) and HIIT (MI-HIIT, n = 12). One week after MI induction, adaptive training starts follow by formal training. After the experiment, cardiac functions were determined by echocardiography and hemodynamic measurements. Changes in infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system (RAAS) activities were measured. Data were analyzed by one-way ANOVA.
RESULTS


After MI, cardiac structure and function were significantly deteriorated. However, post-MI HIIT for 8 weeks had significantly ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax). Moreover, it preserved cardiac functions, reduced infarct size, protected the myocardium structure, increased angiogenesis and decreased the myofibroblasts and collagen accumulation. HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis. Additionally, it induced inflammation response and repressed ET-1 and RAAS activities were found in myocardium and peripheral circulation after HIIT.
CONCLUSION


Our results suggested that post-MI HIIT had a positive role in cardiac repair, which might be linked with the induction of inflammation and inhibition of ET-1 and RAAS activities.",2020,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","['65 male rats underwent', 'rats with acute myocardial infarct']","['Exercise training', 'HIIT', 'coronary ligation or sham operation', 'high-intensity interval training', 'moderate-intensity continuous training']","['RAAS) activities', 'cardiac functions', 'inflammation response and repressed ET-1 and RAAS activities', 'cardiac structure and function', 'myofibroblasts and collagen accumulation', 'LVEDP, -dP/dtmax, infarct size and angiogenesis', 'ameliorated left ventricular end-diastolic pressure (LVEDP), LV systolic pressure (LVSP), and maximum peak velocities of relaxation (-dP/dtmax', 'infarct size, collagen accumulation, myofibroblasts, angiogenesis, inflammation level, endothelin-1 (ET-1), and renin-angiotensin-aldosterone system ']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0225360', 'cui_str': 'Myofibroblast'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",65.0,0.0338951,"HIIT for 4 weeks had no effect on LVEDP, -dP/dtmax, infarct size and angiogenesis.","[{'ForeName': 'Bozhong', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Rongfang', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xinwen', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Shou', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Cuicui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Tong', 'Affiliation': 'Department of Cardiac Rehabilitation, Zhejiang Hospital, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Genxiang', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Zhejiang Provincial Key Laboratory of Geriatrics & Geriatrics Institute of Zhejiang Province, Hangzhou, 310013, Zhejiang, China. Electronic address: aaiwuqing@126.com.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110690']
2108,32891018,Effects of multimodal balance training supported by rhythmical auditory stimuli in people with advanced stages of Parkinson's disease: a pilot randomized clinical trial.,"Non-pharmacological interventions such as physiotherapy are recognized as important elements in the overall clinical management of motor impairments in PD, but evidence of physiotherapy in advanced disease stages is sparse. A recent trial found positive effects of multimodal balance training in people with mild to moderate PD, with greater and more sustained effects when rhythmical auditory stimuli were added. It is unclear whether such multimodal balance training is also effective in people with advanced PD (Hoehn & Yahr stage 4).
METHODS


We performed a pilot prospective single-blind, randomized clinical trial to study the effectiveness of multimodal training with and without rhythmical auditory stimuli. We screened 76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients were assigned randomly into two groups: (1) multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n = 17) and (2) multimodal balance training without rhythmical auditory cues (n = 18). Training was performed for 5 weeks, two times/week. Primary outcome was the Mini-BESTest (MBEST) score immediately after the training period. Assessments were performed by the same two blinded assessors at baseline, immediately post intervention, and after one and 6-months follow-up.
RESULTS


Immediately post-intervention, both intervention groups improved significantly on Mini-Best scores, without differences between both intervention modalities. In both groups, results were retained at one-month follow-up. At 6-months follow-up, the effects were retained only in the RAS-supported intervention group. For both intervention groups, no improvements were found on secondary outcome measures for gait.
CONCLUSION


Both RAS-supported multimodal balance training and regular multimodal balance training improve balance in PD patients in advanced disease stages. Effects appear to sustain longer in the RAS-supported training group.",2020,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","['PD patients in advanced disease stages', ""people with advanced stages of Parkinson's disease"", 'people with advanced PD (Hoehn & Yahr stage 4', 'people with mild to moderate PD', ""76 people with Parkinson's disease and Hoehn & Yahr stage 4 by telephone; 35 patients""]","['multimodal balance training with rhythmical auditory stimuli (RAS-supported intervention, n\xa0=\xa017) and (2) multimodal balance training without rhythmical auditory cues', 'multimodal balance training and regular multimodal balance training', 'multimodal balance training', 'multimodal training with and without rhythmical auditory stimuli']","['Mini-BESTest (MBEST) score', 'gait', 'Mini-Best scores', 'rhythmical auditory stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]",76.0,0.0570846,"For both intervention groups, no improvements were found on secondary outcome measures for gait.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil. Electronic address: tamine.capato@radboudumc.nl.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour; Department of Rehabilitation, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands; Sint Maartenskliniek, Department of Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud University Medical Center, Department for Health Evidence, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'University of São Paulo, Department of Neurology, Movement Disorders Center, São Paulo, Brazil.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Centre of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117086']
2109,32891234,Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial.,"BACKGROUND


Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania.
METHODS


In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556.
FINDINGS


Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
INTERPRETATION


Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care.
FUNDING


National Institute of Mental Health at the US National Institutes of Health.",2020,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","['adults with HIV initiating antiretroviral therapy in Tanzania', 'All participants were included in the primary intention-to-treat analysis', 'adults starting HIV treatment', 'adults aged 18 years or older with HIV who had started ART within the past 30 days', 'Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group', 'patients starting ART in Tanzania']",['tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10\u2008000 Tanzanian Shillings (TZS; about US$4·50) or 22\u2008500 TZS'],"['viral suppression', 'retention in care with viral suppression', 'incentive size and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",530.0,0.294879,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Fahey', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA. Electronic address: cfahey@berkeley.edu.'}, {'ForeName': 'Prosper F', 'Initials': 'PF', 'LastName': 'Njau', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania; Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katabaro', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rashid S', 'Initials': 'RS', 'LastName': 'Mfaume', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Natalino', 'Initials': 'N', 'LastName': 'Mwenda', 'Affiliation': 'Rasello, Dar es Salaam, Tanzania.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Bradshaw', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Padian', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30230-7']
2110,32891268,Auriculotherapy as a means of managing nausea and vomiting in pregnancy: A double-blind randomized controlled clinical trial.,"INTRODUCTION


This study was aimed to assess the effectiveness of auriculotherapy on managing nausea and vomiting during pregnancy.
METHODS


In this randomized clinical trial, 128 pregnant women suffering from nausea and vomiting were selected and assigned to study groups. The data were collected using demographic information and Rhodes' questionnaires and analyzed in SPSS v.22.
RESULTS


After intervention, the average nausea score of the Rhodes index declined significantly in patients in the intervention group (p < 0.001).However, there was no significant (p = 0.305) difference between the two groups regarding vomiting. The results of the repeated measures showed that interventions had a significant effect on the total score of the questionnaire and also the scores regarding nausea (p < 0.04).
CONCLUSION


The appropriate use of effective points on ears to control nausea and vomiting as a non-medicine and complementary treatment can alleviate nausea among pregnant women.",2020,"After intervention, the average nausea score of the Rhodes index declined significantly in patients in the intervention group (p < 0.001).However, there was no significant (p = 0.305) difference between the two groups regarding vomiting.","['pregnant women', '128 pregnant women suffering from nausea and vomiting', 'in pregnancy']","['auriculotherapy', 'Auriculotherapy']","['vomiting', 'nausea and vomiting', 'total score of the questionnaire and also the scores regarding nausea', 'average nausea score of the Rhodes index']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C2350276', 'cui_str': 'Auriculotherapy'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0454812', 'cui_str': 'Rhodes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",128.0,0.132987,"After intervention, the average nausea score of the Rhodes index declined significantly in patients in the intervention group (p < 0.001).However, there was no significant (p = 0.305) difference between the two groups regarding vomiting.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Negarandeh', 'Affiliation': 'Nursing and Midwifery Care Research Centre, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Eghbali', 'Affiliation': 'Department of Nursing،; University of Social Welfare and Rehabilitation Sciences, Tehran, Iran; Student Research Committee, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: m-eghbali@alumnus.tums.ac.ir.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastaran', 'Affiliation': 'Nursing and Midwifery Care Research Centre, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kiarash', 'Initials': 'K', 'LastName': 'Saatchi', 'Affiliation': 'Inspector and Instructor Association of Acupuncture, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101177']
2111,32891269,The feasibility of 'Mind the Bump': A mindfulness based maternal behaviour change intervention.,"BACKGROUND


and purpose: Women's health behaviours during pregnancy can affect their children's lifetime outcomes. Inactivity, poor diet, alcohol, and smoking during pregnancy are linked to maternal stress and distress. Mindfulness-based interventions can improve health behaviours and mental health. The purpose of the study was to develop and evaluate the feasibility of a mindfulness-based maternal behaviour change intervention.
MATERIALS AND METHODS


The eight-week 'Mind the Bump' intervention integrated mindfulness training with behaviour change techniques. It aimed to improve mindfulness, mental health, and adherence to UK maternal health behaviour guidance. Acceptability, practicability, effectiveness/cost-effectiveness, affordability, safety/side-effects, and equity were evaluated from baseline to post-course and follow-up.
RESULTS


Mindfulness, positive affect, and wellbeing improved. Stress, negative affect, depression, anxiety, and adherence to guidance did not improve. The intervention was practicable and safe, but the other implementability criteria were not satisfied.
CONCLUSION


The intervention was not fully feasible; recommendations to address its limitations are discussed.",2020,"Stress, negative affect, depression, anxiety, and adherence to guidance did not improve.",[],['mindfulness-based maternal behaviour change intervention'],"['mindfulness, mental health, and adherence to UK maternal health behaviour guidance', 'Acceptability, practicability, effectiveness/cost-effectiveness, affordability, safety/side-effects, and equity', 'Inactivity, poor diet, alcohol, and smoking during pregnancy', 'health behaviours and mental health', 'Stress, negative affect, depression, anxiety, and adherence to guidance']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024919', 'cui_str': 'Maternal Behavior'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0814630', 'cui_str': 'Affordability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0588012', 'cui_str': 'Diet poor'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0148306,"Stress, negative affect, depression, anxiety, and adherence to guidance did not improve.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Hennelly', 'Affiliation': 'Department of Psychology, Health and Professional Development, Oxford Brookes University, Oxford, OX3 0BP, United Kingdom. Electronic address: shennelly@brookes.ac.uk.'}, {'ForeName': 'Parvati', 'Initials': 'P', 'LastName': 'Perman-Howe', 'Affiliation': 'Department of Psychology, Health and Professional Development, Oxford Brookes University, Oxford, OX3 0BP, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Foxcroft', 'Affiliation': 'Department of Psychology, Health and Professional Development, Oxford Brookes University, Oxford, OX3 0BP, United Kingdom.'}, {'ForeName': 'Lesley A', 'Initials': 'LA', 'LastName': 'Smith', 'Affiliation': 'Institute of Clinical and Applied Health Research, University of Hull, HU6 7RX, United Kingdom.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101178']
2112,32891271,Investigation of the effectiveness of Tai Chi exercise program in patients with scleroderma: A randomized controlled study.,"BACKGROUND


and Purpose: There were studies showing the positive effects of Tai Chi on sleep, fatigue, endurance, balance, anxiety and depression in rheumatologic diseases. The aim of this study was to investigate the effects of Tai Chi exercise program on trunk endurance, balance, sleep, fatigue, anxiety and depression in patients with systemic sclerosis (SSc).
MATERIALS AND METHODS


28 patients were randomly divided into two groups as Tai Chi (n:14, 53.35 ± 10.86 years) and home exercise group (n:14, 52.64 ± 9.45 years). Trunk Lateral Endurance Test, Berg Balance Scale, Pittsburg Sleep Quality Index, Fatigue Severity Scale and Fatigue Impact Scale, Hospital Anxiety and Depression Scale was used for assesment. All evaluations were performed at baseline and at the end of the 10th week.
RESULTS


After training, a statistically significant difference was observed in all parameters in Tai Chi group (p:0.00); there was a significant difference in trunk endurance and sleep quality in the home exercise group (p:0.00-0.03) compared to pre-training. When the delta values between groups were compared, Tai Chi group was superior to home exercise group in all parameters except trunk endurance (p:0.00-0.01). No side effects were observed during the exercises.
CONCLUSION


As a result of our study; Tai Chi has a possitive effect on endurance, balance, sleep quality, fatique, anxiety and depression in patients with SSc. Tai Chi should be included in rehabilitation programs as a safe alternative type of exercise to improve trunk endurance, balance, sleep quality and reduce fatigue, anxiety and depression in patients with SSc.",2020,"After training, a statistically significant difference was observed in all parameters in Tai Chi group (p:0.00); there was a significant difference in trunk endurance and sleep quality in the home exercise group (p:0.00-0.03) compared to pre-training.","['patients with SSc', '28 patients', 'patients with systemic sclerosis (SSc', 'patients with scleroderma']","['Tai Chi', 'home exercise group', 'Tai Chi exercise program']","['trunk endurance, balance, sleep, fatigue, anxiety and depression', 'Trunk Lateral Endurance Test, Berg Balance Scale, Pittsburg Sleep Quality Index, Fatigue Severity Scale and Fatigue Impact Scale, Hospital Anxiety and Depression Scale', 'sleep, fatigue, endurance, balance, anxiety and depression in rheumatologic diseases', 'trunk endurance, balance, sleep quality and reduce fatigue, anxiety and depression', 'endurance, balance, sleep quality, fatique, anxiety and depression', 'side effects', 'trunk endurance and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",28.0,0.0198971,"After training, a statistically significant difference was observed in all parameters in Tai Chi group (p:0.00); there was a significant difference in trunk endurance and sleep quality in the home exercise group (p:0.00-0.03) compared to pre-training.","[{'ForeName': 'Sebahat Yaprak', 'Initials': 'SY', 'LastName': 'Cetin', 'Affiliation': 'Akdeniz University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation, Antalya, Turkey. Electronic address: fzt.ycetin@gmail.com.'}, {'ForeName': 'Bilge Basakci', 'Initials': 'BB', 'LastName': 'Calik', 'Affiliation': 'Pamukkale University, School of Physical Therapy and Rehabilitation, Denizli, Turkey. Electronic address: fztbilge@hotmail.com.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ayan', 'Affiliation': 'Antalya Training and Research Hospital, Department of Rheumatology, Antalya, Turkey. Electronic address: drayseayan@yahoo.com.tr.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101181']
2113,32891496,"A double-blind, randomized controlled trial exploring the efficacy of frequency lowering hearing aids in patients with high-frequency hearing loss.","OBJECTIVE


Whether linear frequency transposition (LFT) assists individuals with hearing difficulties has been studied for years, but no reliable comparison between LFT hearing aids (HAs) and conventional compression-type HAs has been conducted. Herein, we report on the first, relevant, double-blind, randomized controlled trial on this topic using a large sample size. We compared the efficacies of LFT HAs to those of compression-type HAs in patients with high-frequency hearing loss (HFHL); we also reviewed the literature.
METHODS


A total of 103 patients were randomized into three groups: conventional HAs featuring wide dynamic range compression (control group); HAs featuring LFT (LFT group); and HAs employing both LFT and wide dynamic range compression of high frequencies (combined group). Pure tone averages (PTAs), speech recognition thresholds (SRTs), word recognition scores (WRSs), and Abbreviated Profile of Hearing Aid Benefit (APHAB) inventories were assessed at the initial visit and after 3 months of HA use. Subject preferences in terms of continued use of their HAs were also evaluated.
RESULTS


The PTA, SRT, and WRS scores significantly improved in all three groups. No significant among-group differences were evident. The APHAB score significantly improved only in the control group; HA future-use preference was also highest in this group.
CONCLUSION


LFT did not provide an additional benefit for subjects with HFHL over conventional amplification and users preferred conventional HAs featuring wide dynamic range compression.",2020,"The APHAB score significantly improved only in the control group; HA future-use preference was also highest in this group.
","['patients with high-frequency hearing loss', 'patients with high-frequency hearing loss (HFHL', '103 patients', 'assists individuals with hearing difficulties']","['conventional HAs featuring wide dynamic range compression (control group); HAs featuring LFT (LFT group); and HAs employing both LFT and wide dynamic range compression of high frequencies (combined group', 'linear frequency transposition (LFT', 'LFT', 'frequency lowering hearing aids']","['APHAB score', 'PTA, SRT, and WRS scores', 'Pure tone averages (PTAs), speech recognition thresholds (SRTs), word recognition scores (WRSs), and Abbreviated Profile of Hearing Aid Benefit (APHAB) inventories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018780', 'cui_str': 'Upper frequency deafness'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1313969', 'cui_str': 'Hearing difficulty'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040674', 'cui_str': 'Transposition procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015522', 'cui_str': 'Coagulation factor XI'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C4551647', 'cui_str': 'Long QT Syndrome 1'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",103.0,0.0698618,"The APHAB score significantly improved only in the control group; HA future-use preference was also highest in this group.
","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Yakunina', 'Affiliation': 'Institute of Medical Science, Kangwon National University, School of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Nam', 'Affiliation': 'Department of Otolaryngology, Kangwon National University, School of Medicine, Kangwondaehak-gil, Chuncheon 200-701, Republic of Korea. Electronic address: birdynec@kangwon.ac.kr.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.08.021']
2114,32891501,Inpatient link to peer recovery coaching: Results from a pilot randomized control trial.,"BACKGROUND


Few individuals hospitalized with Substance Use Disorder (SUD) complications participate in recovery support services after discharge. Peer recovery coaching represents one potential new method for promoting recovery.
METHODS


A six-month prospective randomized controlled trial compared outcomes between the standard of care and a physician-initiated recovery coaching intervention. The primary outcome measure was engagement in recovery support services, and the secondary outcome measures were substance use frequency and self-reported physical and mental health using the SF-12 survey. Participants (N = 98) were eligible if they were identified by a healthcare provider as having a SUD and were hospitalized due to SUD complications.
RESULTS


Engagement rate over the six-month post-discharge time period was higher for participants in the recovery coaching intervention (84 %, 95 % CI: 78%-91%) compared to the standard of care control condition (34 %, 95 % CI: 25 %-44 %), log OR = 28.59, p < .001. No overall group differences in substance use frequency (p = .80), self-reported physical (p = .69) or mental (p = .89) health were observed.
CONCLUSION


An inpatient linkage to recovery coaching services improves engagement rates and can feasibly be implemented in a single-center inpatient service. This intervention is promising for promoting both short-term and long-term engagement in recovery support services.",2020,"RESULTS


Engagement rate over the six-month post-discharge time period was higher for participants in the recovery coaching intervention (84 %, 95 % CI: 78%-91%) compared to the standard of care control condition (34 %, 95 % CI: 25 %-44 %), log OR = 28.59, p < .001.","['individuals hospitalized with Substance Use Disorder (SUD) complications participate in recovery support services after discharge', 'Participants (N = 98) were eligible if they were identified by a healthcare provider as having a SUD and were hospitalized due to SUD complications']",['standard of care and a physician-initiated recovery coaching intervention'],"['engagement in recovery support services', 'substance use frequency and self-reported physical and mental health using the SF-12 survey', 'discharge time period', 'substance use frequency']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}]",98.0,0.200801,"RESULTS


Engagement rate over the six-month post-discharge time period was higher for participants in the recovery coaching intervention (84 %, 95 % CI: 78%-91%) compared to the standard of care control condition (34 %, 95 % CI: 25 %-44 %), log OR = 28.59, p < .001.","[{'ForeName': 'Kaileigh A', 'Initials': 'KA', 'LastName': 'Byrne', 'Affiliation': 'Clemson University, United States. Electronic address: kaileib@clemson.edu.'}, {'ForeName': 'Prerana J', 'Initials': 'PJ', 'LastName': 'Roth', 'Affiliation': 'Prisma Health-Upstate, United States; University of South Carolina School of Medicine - Greenville, United States.'}, {'ForeName': 'Krupa', 'Initials': 'K', 'LastName': 'Merchant', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Bryana', 'Initials': 'B', 'LastName': 'Baginski', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Robinson', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Dumas', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Collie', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ramsey', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Jen', 'Initials': 'J', 'LastName': 'Cull', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Churitch', 'Affiliation': 'Prisma Health-Upstate, United States.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Rennert', 'Affiliation': 'Clemson University, United States.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Clemson University, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'FAVOR-Greenville, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108234']
2115,32891506,"[Single, immediate postoperative intra-vesical instillation (SI) compared to a single preoperative intra-vesical instillation of mitomycin C in non-muscle invasive bladder cancer (NMIBC). Phase II randomized trial].","OBJECTIVE


A single immediate instillation of mitomycin C is recommended after a complete transurethral resection of the bladder (TURB) in low- and intermediate-risk patients with NMIBC. Actually, post-TURB instillation is seldom used due to logistical difficulties and surgical contraindications. Our aim was to compare patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of mitomycin C.
METHODS


We performed a multicenter randomized trial between February 17, 2014 and November 24, 2016 (registration number 2012-004341-32). Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned. Cystoscopy was performed at 3, 6 and 12 months after TURB. Our primary endpoint was disease-free interval. Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.
RESULTS


Among 35 eligible participants, 20 were randomly assigned in the pre-TURB instillation group and 15 in the post-TURB instillation group. Follow-up was comparable: 12,3±1,6 months in the SI group and 10,2±4,5 months in the pre-TURB instillation group. In the post-TURB instillation group, 2 patients didn't have any instillation. We did not identify significant differences in disease-free interval. Tolerance at 1 month after TURB was similar in both groups.
CONCLUSION


Tolerance and efficacy were not significantly different. As expected, logisitics were easier for the health providers in the pre-TURB group where all patients had their instillation conversely to the post-TURB group. These results suggest that the advantages of a single immediate pre-TURB instillation warrant further evaluation of this strategy in a phase III randomized trial.",2020,"Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.
","['February 17, 2014 and November 24, 2016 (registration number 2012-004341-32', 'Sixty patients with two or less, primary or recurrent papillary bladder tumors and a negative urinary cytology were planned', 'patients with single pre-TURB intra-vesical instillation and patients with a single, immediate post-TURB intra-vesical instillation of', 'low- and intermediate-risk patients with NMIBC', 'non-muscle invasive bladder cancer (NMIBC', '35 eligible participants']","['immediate postoperative intra-vesical instillation (SI', 'TURB instillation group and 15 in the post-TURB instillation', 'mitomycin C']","['recurrence rate', 'disease-free interval', 'Tolerance']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0005695', 'cui_str': 'Neoplasm of bladder'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",60.0,0.0804939,"Secondary endpoints were recurrence rate at 3 and 12 months, rate of patients in whom instillation could not be performed and tolerance 1 month after TURB using BCI-Fr score.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Breton', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France. Electronic address: jbreto200e@gmail.com.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bernardeau', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vallée', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pillot', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebacle', 'Affiliation': ""Service d'urologie, hôpital Bicêtre AP-HP, 78, rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France.""}, {'ForeName': 'P-O', 'Initials': 'PO', 'LastName': 'Delpech', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Charles', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Biscans', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vallat', 'Affiliation': ""Service d'urologie, CHU de Poitiers, 2, rue de la Milétrie, 86000 Poitiers, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Pfister', 'Affiliation': ""Service d'urologie, CHU de Rouen, 37, boulevard Gambetta, 76000 Rouen, France.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Irani', 'Affiliation': ""Service d'urologie, hôpital Bicêtre AP-HP, 78, rue du Général Leclerc, 94270 Le Kremlin-Bicêtre, France.""}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.07.245']
2116,32894959,Efficacy of pectoral nerve block type II versus thoracic paravertebral block for analgesia in breast cancer surgery.,"BACKGROUND


Ultrasound-guided pectoral nerve block type II is a recently proposed technique for postoperative analgesia after breast cancer surgery. The thoracic paravertebral block is widely used for this purpose by decades. The presented study compares the efficacy of these two techniques for postoperative analgesia.
MATERIALS AND METHODS


Sixty adult women were undergoing unilateral radical mastectomy or quadrantectomy with axillary dissection. The patients were randomized to receive either pectoral nerve block with 30ml ropivacaine 0.375% (Pecs group) or thoracic paravertebral block with 20ml ropivacaine 0.5% (TPVB group). The evaluated variables included pain intensity by the numerical rating scale at 0, 2, 4, 6, 12, 18 and the 24 hours, 24-hour postoperative opioid (promedol) and nonopioid (ketoprofen) consumption and the time to first rescue analgesia.
RESULTS


There were no statistically significant differences between both groups in the pain intensity after surgery. Ten (33%) patients from Pecs group and nine (30%) patients from TPVB group did not require any analgesia within the first 24 hours (P = 0.793). The mean postoperative ketoprofen consumption was lower in Pecs group: 63.3 (± 66.87) mg vs. 90.0 (± 84.49) mg (&#1056; = 0.283). The number of patients who required promedol was 6 (20%) vs. 8 (27%) in Pecs and TPVB groups, respectively (&#1056; = 0.542). The time to first analgesic request was longer in Pecs group, 550 (400.0-600.0) min vs. 510 (360.0-600.0) min (&#1056; = 0.506) in TPVB group.
CONCLUSIONS


In breast cancer surgery, the pectoral nerve block type II with ropivacaine 0.375% can provide postoperative analgesia that is comparable to the single-level thoracic paravertebral block.",2020,The mean postoperative ketoprofen consumption was lower in Pecs group: 63.3 (± 66.87) mg vs. 90.0 (± 84.49) mg (&#1056; = 0.283).,"['Sixty adult women were undergoing', 'postoperative analgesia after breast cancer surgery', 'breast cancer surgery']","['pectoral nerve block with 30ml ropivacaine 0.375% (Pecs group) or thoracic paravertebral block with 20ml ropivacaine 0.5% (TPVB', 'pectoral nerve block type II versus thoracic paravertebral block', 'ropivacaine', 'unilateral radical mastectomy or quadrantectomy with axillary dissection']","['number of patients who required promedol', 'mean postoperative ketoprofen consumption', 'time to first analgesic request', '24-hour postoperative opioid (promedol) and nonopioid (ketoprofen) consumption and the time to first rescue analgesia', 'pain intensity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0024884', 'cui_str': 'Radical mastectomy'}, {'cui': 'C0337354', 'cui_str': 'Quadrantectomy of breast'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033400', 'cui_str': 'Dimethylmeperidine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0242937', 'cui_str': 'Non-opioid analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",60.0,0.0587933,The mean postoperative ketoprofen consumption was lower in Pecs group: 63.3 (± 66.87) mg vs. 90.0 (± 84.49) mg (&#1056; = 0.283).,"[{'ForeName': 'Volodymyrovych Volodymyr', 'Initials': 'VV', 'LastName': 'Martsiniv', 'Affiliation': ''}, {'ForeName': 'Anatoliiovych Oleg', 'Initials': 'AO', 'LastName': 'Loskutov', 'Affiliation': ''}, {'ForeName': 'Mykolaiovych Andriy', 'Initials': 'MA', 'LastName': 'Strokan', 'Affiliation': ''}, {'ForeName': 'Mykolaiovych Maksim', 'Initials': 'MM', 'LastName': 'Pylypenko', 'Affiliation': ''}, {'ForeName': 'Volodymyrovych Mihailo', 'Initials': 'VM', 'LastName': 'Bondar', 'Affiliation': ''}]",Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti,['10.14735/amko2020296']
2117,32894967,Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial.,"BACKGROUND


Cardiovascular diseases (CVDs) are the leading cause of death in Iran. A fixed-dose combination therapy (polypill) was proposed as a cost-effective strategy for CVD prevention, especially in lower-resource settings. We conducted the PolyPars trial to assess the effectiveness and safety of polypill for prevention of CVD.
METHODS


The PolyPars trial is a pragmatic cluster randomized controlled trial nested within the Pars Cohort Study. Participants were randomized to an intervention arm and a control arm. Participants in the control arm received minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care. The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg. The primary outcome of the study is defined as the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions. The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
RESULTS


From December 2014 to December 2015, 4415 participants (91 clusters) were recruited. Of those, 2200 were in the polypill arm and 2215 in the minimal care arm. The study is ongoing. This trial was registered with ClinicalTrials.gov number NCT03459560.
CONCLUSION


Polypill may be effective for primary prevention of CVDs in developing countries.",2020,"The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
","['4415 participants (91 clusters) were recruited', 'From December 2014 to December 2015']","['enalapril 5 mg or valsartan', 'hydrochlorothiazide', 'aspirin 81 mg, atorvastatin', 'minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care']","['adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up', 'acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0020261', 'cui_str': 'Hydrochlorothiazide'}, {'cui': 'C0983882', 'cui_str': 'Aspirin 81 MG'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",4415.0,0.193684,"The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Gandomkar', 'Affiliation': 'Non-Communicable Disease Research Center, Shiraz University of medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zinab', 'Initials': 'Z', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Poustchi', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Moghadami', 'Affiliation': 'Non-Communicable Disease Research Center, Shiraz University of medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Fattahi', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Moini', 'Affiliation': 'Gastroenterohepatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushiravani', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Mortazavi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Sadeghi Boogar', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mohammadkarimi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Abtahi', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Center School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Sadaf G', 'Initials': 'SG', 'LastName': 'Sepanlou', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Malekzadeh', 'Affiliation': 'Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Teheran, Iran.'}]",Archives of Iranian medicine,['10.34172/aim.2020.58']
2118,32894993,Preoperative Gabapentin Administration and Its Impact on Postoperative Opioid Requirement and Pain in Sinonasal Surgery.,"OBJECTIVE


To determine the efficacy of preoperative gabapentin on patient-reported pain levels and postoperative opioid requirements following sinonasal surgery.
STUDY DESIGN


Retrospective review.
SETTING


Academic institution.
METHODS


Patients undergoing sinonasal surgery between July 2019 and January 2020 were followed. Groups were divided into those that received 600 mg of oral gabapentin 1 hour preoperatively (gabapentin) and those that did not (control). Postoperatively, each patient was counseled to use acetaminophen, ibuprofen, and oxycodone as needed for pain control. Patients completed a daily postoperative pain and medication log. Pain was measured by the visual analog scale (VAS) and opioid use by morphine equivalent dose (MED). Chi-square test and Wilcoxon test were used for data analysis.
RESULTS


Fifty-seven patients were included (control, n = 28; gabapentin, n = 29). There was no significant difference in age, sex, or baseline Sinonasal Outcome Test-22 scores between the groups. The total MED, postoperative day (POD) 1-2 MED, POD 3-4 MED, and POD 5-6 MED did not differ significantly between the control (17.9, 12.2, 4.6, 1.5) and gabapentin (19.0, 8.9, 7.2, 3.5) groups ( P  = .98, .25, .16, .44). The mean daily VAS score did not differ significantly between the control (3.1) and gabapentin (2.8) groups ( P  = .81). The mean daily VAS score decreased significantly in both groups with each successive POD ( P  = .004).
CONCLUSION


Preoperative gabapentin did not significantly reduce postoperative pain or opioid use. Postoperative discomfort following sinonasal surgery is mild, and opioid intake is minimal.",2020,"There was no significant difference in age, sex, or baseline Sinonasal Outcome Test-22 scores between the groups.","['Fifty-seven patients were included (control, n = 28; gabapentin, n = 29', 'Patients undergoing sinonasal surgery between July 2019 and January 2020 were followed', 'Academic institution', 'Sinonasal Surgery']","['acetaminophen, ibuprofen, and oxycodone', 'Preoperative Gabapentin', 'preoperative gabapentin', 'gabapentin', 'oral gabapentin 1 hour preoperatively (gabapentin']","['total MED, postoperative day (POD) 1-2 MED, POD 3-4 MED, and POD 5-6 MED', 'Postoperative discomfort', 'postoperative pain', 'daily postoperative pain and medication log', 'Pain', 'visual analog scale (VAS) and opioid use by morphine equivalent dose (MED', 'Postoperative Opioid Requirement and Pain', 'mean daily VAS score']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1273517', 'cui_str': 'Used by'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",57.0,0.035835,"There was no significant difference in age, sex, or baseline Sinonasal Outcome Test-22 scores between the groups.","[{'ForeName': 'Amarbir S', 'Initials': 'AS', 'LastName': 'Gill', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Farrukh R', 'Initials': 'FR', 'LastName': 'Virani', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hwang', 'Affiliation': 'Davis School of Medicine, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Machelle D', 'Initials': 'MD', 'LastName': 'Wilson', 'Affiliation': 'Department of Public Health Sciences/Biostatistics, Clinical and Translational Science Center, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Beliveau', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'E Bradley', 'Initials': 'EB', 'LastName': 'Strong', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of California Davis, Sacramento, California, USA.'}, {'ForeName': 'Toby O', 'Initials': 'TO', 'LastName': 'Steele', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of California Davis, Sacramento, California, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820952805']
2119,32895004,"Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions.","BACKGROUND


The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.
METHODS


From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.
RESULTS


Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%;  P <0.01) and target vessel myocardial infarction (4.2% versus 7.6%;  P <0.01) were significantly lower in BP-SES than in DP-EES. No difference in the outcome between the stents was shown in patients with non-small vessel lesions. In patients with calcified lesions, target lesion failure (12.2% versus 6.9%;  P =0.056), and cardiac death (1.9% versus 0.3%;  P =0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups.
CONCLUSIONS


Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.",2020,"In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES.","['patients with non-small vessel lesions', 'total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available', 'patients with more complex disease representing a higher risk of target lesion failure', 'Subjects']","['polymer everolimus-eluting stent (DP-EES', 'Orsiro Sirolimus Eluting Coronary Stent System', 'ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES', 'DP-EES', 'Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents']","['BP-SES', 'De Novo or Restenotic Coronary Artery Lesions ', 'Coronary lesions', 'target lesion failure', 'Stent thrombosis', 'Safety and Effectiveness', 'cardiac death', 'target vessel myocardial infarction', 'vessel myocardial infarction in DP-EES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0205168', 'cui_str': 'Thin'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]",1553.0,0.0742964,"In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES.","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Dan', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}, {'ForeName': 'Hector M', 'Initials': 'HM', 'LastName': 'Garcia-Garcia', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kolm', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Switzerland (S.W.).'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Switzerland (S.W.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA (D.E.K.).'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington DC (K.D., H.M.G.-G., P.K., R.W.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009189']
2120,32895116,Efficacy of telemonitoring system in continuous positive airway pressure therapy in Asian obstructive sleep apnea.,"STUDY OBJECTIVES


Telemonitoring system is a promising wireless technology which possibly enhances the adherence to CPAP therapy. The study aimed to determine the effect of telemonitoring system on CPAP therapy adherence among Asians with moderate-to-severe OSA.
METHODS


A prospective randomized controlled trial enrolled 60 Asian adults with moderate-to-severe OSA. Thirty patients each were randomized to CPAP with telemonitoring system (TM group) or CPAP with usual care (UC group). Telemonitoring system functions by transferring CPAP-usage data via cellular network. When there were any triggers occurring 2 nights consecutively (usage hour<4 hours per night, leakage>27 L/min or AHI>5/hour), the investigator contacted the patients. The primary outcome was the 4-week CPAP usage hour per night. The secondary outcome included % good adherence (defined as a 4-week period of therapy with CPAP usage >4 hours/night on >70% of total days), median leakage per night, adverse events from CPAP therapy, sleep quality improvement, and daytime sleepiness reduction.
RESULTS


Seventy percent of the participants were male and mean AHI was 50.3/hour. The mean 4-week CPAP usage hour per night was insignificantly higher in TM group (5.16 ±1.47 hour/night vs 4.42 ±1.91 hour/night, p-value = 0.18). However, % good adherence was significantly higher in TM group (64.2% vs 34.4%, p-value = 0.024). Median leakage per night was also significantly lower in TM group. Furthermore, significant sleep quality improvement was observed in TM group. Overall adverse events and daytime sleepiness reduction were not different.
CONCLUSIONS


The telemonitoring system implementation demonstrated a trend towards increasing in CPAP nightly hour usage and significantly improved adherence as well as sleep quality among Asian moderate-to-severe OSA.",2020,"However, % good adherence was significantly higher in TM group (64.2% vs 34.4%, p-value = 0.024).","['Asian obstructive sleep apnea', 'Thirty patients each were randomized to', 'Asians with moderate-to-severe OSA', '60 Asian adults with moderate-to-severe OSA', 'Seventy percent of the participants were male and mean AHI was 50.3/hour']","['CPAP with telemonitoring system (TM group) or CPAP with usual care (UC group', 'continuous positive airway pressure therapy', 'telemonitoring system']","['sleep quality improvement', 'good adherence', '4-week CPAP usage hour per night', 'Median leakage per night', 'mean 4-week CPAP usage hour per night', 'sleep quality', 'CPAP therapy adherence', 'CPAP usage >4 hours/night on >70% of total days), median leakage per night, adverse events from CPAP therapy, sleep quality improvement, and daytime sleepiness reduction', 'Overall adverse events and daytime sleepiness reduction']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1292426', 'cui_str': '4 hours'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",60.0,0.0373264,"However, % good adherence was significantly higher in TM group (64.2% vs 34.4%, p-value = 0.024).","[{'ForeName': 'Worawat', 'Initials': 'W', 'LastName': 'Chumpangern', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Dittapol', 'Initials': 'D', 'LastName': 'Muntham', 'Affiliation': 'Section for Mathematics, Faculty of Science and Technology, Rajamangala University of Technology Suvarnabhumi, Phranakhon Si Ayutthaya, Thailand.'}, {'ForeName': 'Naricha', 'Initials': 'N', 'LastName': 'Chirakalwasan', 'Affiliation': 'Excellence Center for Sleep Disorders, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8772']
2121,32895160,[Inverse ratio ventilation combined with PEEP in infants undergoing thoracoscopic surgery with one lung ventilation for lung cystadenomas: a randomized control trial of 63 cases].,"OBJECTIVE


To investigate the effect of inverse ratio ventilation (IRV) combined with positive end-expiratory pressure (PEEP) in infants undergoing thoracoscopic surgery with single lung ventilation (OLV) for lung cystadenomas.
METHODS


A total of 66 infants undergoing thoracoscopic surgery with OLV for lung cystadenomas in our hospital from February, 2018 to February, 2019 were randomized into conventional ventilation groups (group N,  n =33) and inverse ventilation group (group R,  n =33). Hemodynamics and respiratory parameters of the infants were recorded and arterial blood gas analysis was performed at 15 min after two lung ventilation (TLV) (T 1 ), OLV30 min (T 2 ), OLV60 min (T 3 ), and 15 min after recovery of TLV (T 4 ). Bronchoalveolar lavage fluid was collected before and after surgery to detect the expression level of advanced glycation end product receptor (RAGE).
RESULTS


Sixty-three infants were finally included in this study. At T 2  and T 3 , Cdyn, PaO 2  and OI in group R were significantly higher ( P  &lt; 0.05) and Ppeak, PaCO 2  and PA-aO 2  were significantly lower than those in group N ( P  &lt; 0.05). There was no significant difference in HR or MAP between the two groups at T 2  and T 3  ( P  &gt; 0.05). The level of RAGE significantly increased after the surgery in both groups ( P  &lt; 0.05), and was significantly lower in R group than in N group ( P  &lt; 0.05).
CONCLUSIONS


In infants undergoing thoracoscopic surgery with OLV for pulmonary cystadenoma, appropriate IRV combined with PEEP does not affect hemodynamic stability and can increases pulmonary compliance, reduce the peak pressure, and improve oxygenation to provide pulmonary protection.",2020,There was no significant difference in HR or MAP between the two groups at T 2  and T 3  ( P  &gt; 0.05).,"['infants undergoing thoracoscopic surgery with one lung ventilation for lung cystadenomas', 'Sixty-three infants were finally included in this study', 'infants undergoing', 'infants undergoing thoracoscopic surgery with OLV for pulmonary cystadenoma', '66 infants undergoing thoracoscopic surgery with OLV for lung cystadenomas in our hospital from February, 2018 to February, 2019 were randomized into']","['inverse ratio ventilation (IRV) combined with positive end-expiratory pressure (PEEP', 'Inverse ratio ventilation combined with PEEP', 'inverse ventilation group', 'thoracoscopic surgery with single lung ventilation (OLV', 'conventional ventilation']","['Ppeak, PaCO 2  and PA-aO 2', 'Hemodynamics and respiratory parameters', 'HR or MAP', 'Bronchoalveolar lavage fluid', 'hemodynamic stability', 'level of RAGE']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0010633', 'cui_str': 'Cystadenoma'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034634', 'cui_str': 'Rage'}]",66.0,0.035269,There was no significant difference in HR or MAP between the two groups at T 2  and T 3  ( P  &gt; 0.05).,"[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Mudan', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Mingyang', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Zurong', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, Guangdong Women and Children's Hospital, Guangzhou 511400, China.""}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.07.14']
2122,32895271,Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol.,"INTRODUCTION


A huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.
INTERVENTION


YOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.
METHODS AND ANALYSIS


This is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6-6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20-30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.
ETHICS AND DISSEMINATION


Ethics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.
TRIAL REGISTRATION NUMBER


CTRI/2019/05/018893.",2020,Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM.,"['high risk people in India', 'people at high risk of T2DM', 'Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6-6.9\u2009mmol/L) and safe to participate in physical activities']","['type-2 diabetes prevention (YOGA-DP', 'T2DM prevention (YOGA-DP', 'Yoga programme', 'YOGA-DP is a structured lifestyle education and exercise programme', 'Physical activity and a healthy diet (healthy lifestyle', 'Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices']",['blood glucose levels'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",,0.113295,Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM.,"[{'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Chattopadhyay', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK kaushik.chattopadhyay@nottingham.ac.uk.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Mishra', 'Affiliation': 'Centre for Chronic Disease Control, Delhi, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'Centre for Chronic Disease Control, Delhi, India.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamer', 'Affiliation': 'Institute Sport Exercise and Health, Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Sheila Margaret', 'Initials': 'SM', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sarah Anne', 'Initials': 'SA', 'LastName': 'Lewis', 'Affiliation': 'Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Nandi Krishnamurthy', 'Initials': 'NK', 'LastName': 'Manjunath', 'Affiliation': 'Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India.'}, {'ForeName': 'Rukamani', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Bapu Nature Cure Hospital and Yogashram, Delhi, India.'}, {'ForeName': 'Somnath', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Bapu Nature Cure Hospital and Yogashram, Delhi, India.'}, {'ForeName': 'David Ross', 'Initials': 'DR', 'LastName': 'Harper', 'Affiliation': 'Harper Public Health Consulting Limited, London, UK.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Kinra', 'Affiliation': 'London School of Hygiene And Tropical Medicine, London, UK.'}, {'ForeName': 'Dorairaj', 'Initials': 'D', 'LastName': 'Prabhakaran', 'Affiliation': 'Centre for Chronic Disease Control, Delhi, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036277']
2123,32895281,"Restrictive transfusion strategy for critically injured patients (RESTRIC) trial: a study protocol for a cluster-randomised, crossover non-inferiority trial.","INTRODUCTION


Resuscitation using blood products is critical during the acute postinjury period. However, the optimal target haemoglobin (Hb) levels have not been adequately investigated. With the restrictive transfusion strategy for critically injured patients (RESTRIC) trial, we aim to compare the restrictive and liberal red blood cell (RBC) transfusion strategies.
METHODS AND ANALYSIS


This is a cluster-randomised, crossover, non-inferiority trial of patients with severe trauma at 22 hospitals that have been randomised in a 1:1 ratio based on the use of a restrictive or liberal transfusion strategy with target Hb levels of 70-90 or 100-120 g/L, respectively, during the first year. Subsequently, after 1-month washout period, another transfusion strategy will be applied for an additional year. RBC transfusion requirements are usually unclear on arrival at the emergency department. Therefore, patients with severe bleeding, which could lead to haemorrhagic shock, will be included in the trial based on the attending physician's judgement. Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit. The outcomes measured will include the 28-day survival rate after arrival at the emergency department (primary), the cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary). Demonstration of the non-inferiority of restrictive transfusion will emphasise its clinical advantages.
ETHICS AND DISSEMINATION


The trial will be performed according to the Japanese and International Ethical guidelines. It has been approved by the Ethics Committee of each participating hospital and The Japanese Association for the Surgery of Trauma (JAST). Written informed consent will be obtained from all patients or their representatives. The results of the trial will be disseminated to the participating hospitals and board-certified educational institutions of JAST, submitted to peer-reviewed journals for publication, and presented at congresses.
TRIAL REGISTRATION NUMBER


UMIN Clinical Trials Registry; UMIN000034405. Registered 8 October 2018.",2020,Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit.,"['patients with severe bleeding, which could lead to haemorrhagic shock', 'patients with severe trauma at 22 hospitals']",['restrictive and liberal red blood cell (RBC) transfusion strategies'],"['28-day survival rate', 'cumulative amount of blood transfused, event-free days and frequency of transfusion-associated lung injury and organ failure (secondary']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.167684,Each RBC transfusion strategy will be applied until 7 days postadmission to the hospital or discharge from the intensive care unit.,"[{'ForeName': 'Mineji', 'Initials': 'M', 'LastName': 'Hayakawa', 'Affiliation': 'Department of Emergency Medicine, Hokkaido University Hospital, Sapporo, Japan mineji@dream.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tagami', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'IIjima', 'Affiliation': 'GBS Japan Biostatistics, R&D, Amgen K.K, Tokyo, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kudo', 'Affiliation': 'Division of Emergency and Critical Care Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sekine', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Saiseikai Central Hospital, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Department of Emergency Medicine & Critical Care Medicine, Advanced Medical Emergency and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yumoto', 'Affiliation': 'Emergency, Critical Care, and Disaster Medicine, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Juntendo University Urayasu Hospital, Urayasu, Chiba, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Endo', 'Affiliation': 'Trauma and Acute Critical Care Centre, Medical Hospital of Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Emergency Medicine, Division of Acute Care Surgery, Teikyo University School of Medicine Graduate School of Medicine, Itabashi-ku, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Matsumura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine, Chiba, Chiba, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Kushimoto', 'Affiliation': 'Division of Emergency and Critical Care Medicine, Tohoku University School of Medicine, Sendai, Miyagi, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-037238']
2124,32895283,"Experiencing the risk of overutilising opioids among patients with chronic non-cancer pain in ambulatory care (ERONA): the protocol of an exploratory, randomised controlled trial.","INTRODUCTION


The US opioid crisis and increasing prescription rates in Europe suggest inappropriate risk perceptions and behaviours of people who prescribe, take or advise on opioids: physicians, patients and pharmacists. Findings from cognitive and decision science in areas other than drug safety suggest that people's risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description.  E xperiencing the  r isk of overutilising  o pioids among patients with chronic  n on-cancer pain in  a mbulatory care (ERONA) is the first-ever conducted trial that aims at investigating the effects of these two modes of learning on individuals' risk perception and behaviour in the long-term administration of WHO-III opioids in chronic non-cancer pain.
METHODS AND ANALYSIS


ERONA-an exploratory, randomised controlled online survey intervention trial with two parallel arms-will examine the opioid-associated risk perception and behaviour of four groups involved in the long-term administration of WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances. Participants will be randomly assigned to one of two online risk education interventions, description based or experiencebased. Both interventions will present the best medical evidence available. Participants will be queried at baseline and after intervention on their risk perception of opioids' benefit-harm ratio, their medical risk literacy and their current/intended risk behaviour (in terms of prescribing, taking or counselling, depending on study group). A follow-up will occur after 9 months, when participants will be queried on their actual risk behaviour. The study was developed by the authors and will be conducted by the market research institution IPSOS Health.
ETHICS AND DISSEMINATION


The study was approved by the Institutional Review Board of the Max Planck Institute for Human Development. Results will be disseminated through peer-reviewed journals, conference presentations and social media.
TRIAL REGISTRATION NUMBER


DRKS00020358.",2020,Findings from cognitive and decision science in areas other than drug safety suggest that people's risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description.  ,"['WHO-III opioids: (1) family physicians, (2) physicians specialised in pain therapy, (3) patients with chronic (≥3 months) non-cancer pain and (4) pharmacists who regularly dispense narcotic substances', 'patients with chronic non-cancer pain in ambulatory care (ERONA', 'patients with chronic  n on-cancer pain in  a mbulatory care (ERONA']","['online risk education interventions, description based or experiencebased']",[],"[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0546803,Findings from cognitive and decision science in areas other than drug safety suggest that people's risk perception and behaviour can differ depending on whether they learnt about a risk through personal experience or description.  ,"[{'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Wegwarth', 'Affiliation': 'Center for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, Germany wegwarth@mpib-berlin.mpg.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité, Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Schulte', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Charité, Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Joerg J', 'Initials': 'JJ', 'LastName': 'Meerpohl', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmucker', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Edris', 'Initials': 'E', 'LastName': 'Nury', 'Affiliation': 'Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Brockmann', 'Affiliation': 'Institute for Theoretical Biology and Integrative Research, Humboldt University of Berlin, Berlin, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Donner-Banzhoff', 'Affiliation': 'Department of Primary Care, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wind', 'Affiliation': 'Berlin Chamber of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Goebel', 'Affiliation': 'Berlin Chamber of Pharmacists, Berlin, Germany.'}, {'ForeName': 'Wolf-Dieter', 'Initials': 'WD', 'LastName': 'Ludwig', 'Affiliation': 'Drug Commission of the German Medical Association, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Hertwig', 'Affiliation': 'Center for Adaptive Rationality, Max-Planck-Institut für Bildungsforschung, Berlin, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-037642']
2125,32895286,Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol.,"INTRODUCTION


Despite well-established guidelines and benefits to exercise, the majority of pregnant women in the USA fail to meet recommended activity levels. Studies need to determine feasible ways to translate clinical interventions to community settings by engaging pregnant women in widely accessible locations to ensure benefits to more women. The aim of this study is to adapt and determine feasibility, acceptability and fidelity of the research clinic-based  Expecting  intervention (NCT02125149) with pregnant women with obesity in community settings.
METHODS AND ANALYSIS


We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community. REP provides a four-phase process for implementing evidence-based interventions including collection of feedback from community stakeholders, iterative piloting of the intervention in the community and a process for standardising the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. We will randomise half to receive the community-adapted  Expecting  intervention (intervention, N=30) and half to receive standard of care (control, N=30). Feasibility and Acceptability of Intervention Measures are primary outcomes as key indicators of feasibility. Secondary outcomes will include the number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery (ie, body mass index, blood pressure and total cholesterol).
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board (#260132). Findings will be shared with study participants and stakeholder advisors through written summaries and in-person presentations; results will also be shared through presentations at scientific conferences and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04298125; Pre-results.",2020,We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community.,"['60 expecting women', 'pregnant women with obesity in community settings', 'pregnant women to community-based delivery']","['exercise intervention', 'research clinic-based  Expecting  intervention']","['number of intervention sessions completed, the change in the number of minutes of physical activity as measured by accelerometer, as well as change in health indicators from enrolment to time of delivery and 6 months post-delivery', 'ie, body mass index, blood pressure and total cholesterol']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1562039', 'cui_str': 'Number of minutes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1301668', 'cui_str': 'Time of delivery'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",60.0,0.0791685,We will use the Replicating Effective Programs (REP) to guide the adaptation and implementation of the research clinic-based intervention into the community.,"[{'ForeName': 'Taren', 'Initials': 'T', 'LastName': 'Swindle', 'Affiliation': 'Family and Preventive Medicine, University of Arkansas For Medical Sciences, Little Rock, Arkansas, USA tswindle@uams.edu.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, Arkansas, USA.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Børsheim', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, Arkansas, USA.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, Little Rock, Arkansas, USA.""}]",BMJ open,['10.1136/bmjopen-2020-038582']
2126,32895345,[Development and Evaluation of the Life Respect Enhancement Program for Nursing Officers].,"PURPOSE


The present study was conducted to develop the Life Respect Enhancement Program and test its effectiveness on suicide knowledge, suicide intervention skills, self-efficacy in suicide prevention, and gatekeeper behaviors among nursing officers.
METHODS


The program was developed according to the ADDIE model and finalized after practical need analysis, expert verification, and a preliminary study. The present study used a concurrent embedded mixed-method research design. To compare the effects of the Program and the control group on the outcome variables, a quantitative study was conducted using a nonequivalent control group with a pretest-posttest design. Quantitative data were analyzed using χ²-tests, t-tests, and RM-ANOVA. A qualitative study was conducted using FGI with six members of the experimental group 3 months after intervention completion.
RESULTS


In total, 56 nursing officers participated in the 3-month follow-up test. Compared to the control group, the experimental group showed significant improvements in suicide knowledge, suicide intervention skills, and self-efficacy in suicide prevention scores at post-test. The significant group differences in suicide knowledge and suicide intervention skills were maintained at 3 months. The gatekeeper behavior scores of the experimental group were also significantly higher than those of the control group at 3 months. Qualitative analysis of the participants' experiences with the Program yielded two themes and seven sub-themes.
CONCLUSION


The newly developed Life Respect Enhancement Program demonstrates significant effects on suicide knowledge, suicide intervention skills, and gatekeeper behaviors. Thus, this program is recommended to promote suicide prevention competencies among nursing officers in military clinical settings.",2020,The gatekeeper behavior scores of the experimental group were also significantly higher than those of the control group at 3 months.,['56 nursing officers participated in the 3-month follow-up test'],[],"['gatekeeper behavior scores', 'suicide knowledge, suicide intervention skills, and self-efficacy in suicide prevention scores', 'suicide knowledge and suicide intervention skills', 'suicide knowledge, suicide intervention skills, and gatekeeper behaviors']","[{'cui': 'C0401990', 'cui_str': 'Nursing officer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}]",56.0,0.0176863,The gatekeeper behavior scores of the experimental group were also significantly higher than those of the control group at 3 months.,"[{'ForeName': 'Sunyoung', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Division of Clinical Nursing, Korea Armed Forces Nursing Academy, Daejeon, Korea.'}, {'ForeName': 'Heeseung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'College of Nursing · The Research Institute of Nursing Science, Seoul National University, Seoul, Korea. hchoi20@snu.ac.kr.'}]",Journal of Korean Academy of Nursing,['10.4040/jkan.20055']
2127,32895353,Intra-articular hyaluronic acid injection vs. atorvastatin; which treatment is more effective in controlling symptoms of knee osteoarthritis? A clinical trial.,"BACKGROUND


Knee osteoarthritis is a disease of the elderly population. Two of the widely used treatment options for knee osteoarthritis is administration of oral atorvastatin and intra articular hyaluronic acid. This study was designed to compare the effects of oral atorvastatin and intra articular Hyaluronic acid in patients with knee osteoarthritis.
METHOD


This study was conducted under the approval of Mashhad University of medical sciences ethic committee. Seventy patients with knee OA were divided randomly into two groups; thirty five subjects were given intra articular Hyaluronic acid injections weekly for three weeks and 35 were given atorvastatin 40 milligrams orally daily for 6 months. WOMAC questioner was filled for each patient at the beginning of the study and every month up to 6 months. Data were analyzed with SPSS version 16.
RESULTS


Enrolled subjects were consisted of 28 males (40%) and 42 females (60%), and their mean age was 57.9±1.1 years. Study groups were similar regarding gender and age distribution (P=0.626, P=0.710, respectively) significant difference between groups regarding sex (P=0.626). Mean age of patients was 57.9±1.1 years. Groups mean age did not differ significantly (P=0.710). According to WOMAC questionnaire, pain score in the second month after injection was significantly lower in the Hyaluronic acid group compared with atorvastatin (P<0.001). Function score in the second month after injection was significantly lower in the Hyaluronic acid group compared with atorvastatin (P<0.001). These differences were absent in the following months.
CONCLUSION


Compared to atorvastatin group, significant improvements in pain symptoms and physical function of knee OA patients were observed in intra articular Hyaluronic acid treatment group in the second month after treatment. But this improvement did not last through the following months.",2020,Function score in the second month after injection was significantly lower in the Hyaluronic acid group compared with atorvastatin (P<0.001).,"['Enrolled subjects were consisted of 28 males (40%) and 42 females (60%), and their mean age was 57.9±1.1 years', 'Seventy patients with knee OA', 'patients with knee osteoarthritis']","['oral atorvastatin and intra articular hyaluronic acid', 'Intra-articular hyaluronic acid injection vs. atorvastatin', 'Hyaluronic acid', 'intra articular Hyaluronic acid injections', 'atorvastatin', 'atorvastatin 40 milligrams orally daily for 6 months', 'oral atorvastatin and intra articular Hyaluronic acid']","['pain symptoms and physical function of knee OA patients', 'WOMAC questioner', 'Function score', 'WOMAC questionnaire, pain score']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",70.0,0.0151988,Function score in the second month after injection was significantly lower in the Hyaluronic acid group compared with atorvastatin (P<0.001).,"[{'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Jokar', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mirfeizi', 'Affiliation': ''}, {'ForeName': 'Hamzeh', 'Initials': 'H', 'LastName': 'Zarei', 'Affiliation': ''}, {'ForeName': 'Kamila', 'Initials': 'K', 'LastName': 'Hashemzadeh', 'Affiliation': ''}]",Acta reumatologica portuguesa,[]
2128,32895463,Correction: Early use of combined exogenous surfactant and inhaled nitric oxide reduces treatment failure in persistent pulmonary hypertension of the newborn: a randomized controlled trial.,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['persistent pulmonary hypertension of the newborn'],['combined exogenous surfactant and inhaled nitric oxide'],[],"[{'cui': 'C0031190', 'cui_str': 'Persistent pulmonary hypertension of the newborn'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}]",[],,0.0584411,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile. alvgonza@med.puc.cl.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Bancalari', 'Affiliation': 'Hospital Guillermo Grant Benavente and Department of Pediatrics, Faculty of Medicine, Universidad de Concepción, Concepción, Chile.'}, {'ForeName': 'Waldo', 'Initials': 'W', 'LastName': 'Osorio', 'Affiliation': 'Hospital Luis Tisné, Santiago, Chile.'}, {'ForeName': 'Matías', 'Initials': 'M', 'LastName': 'Luco', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Hospital San José, Santiago, Chile.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Pérez', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Kattan', 'Affiliation': 'Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-00806-9']
2129,32895571,Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial.,"We report on molecular analyses of baseline tumor samples from the phase 3 JAVELIN Renal 101 trial (n = 886; NCT02684006), which demonstrated significantly prolonged progression-free survival (PFS) with first-line avelumab + axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We found that neither expression of the commonly assessed biomarker programmed cell death ligand 1 (PD-L1) nor tumor mutational burden differentiated PFS in either study arm. Similarly, the presence of FcɣR single nucleotide polymorphisms was unimpactful. We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types. These findings provide insight into the determinants of response to combined PD-1/PD-L1 and angiogenic pathway inhibition and may aid in the development of strategies for improved patient care in aRCC.",2020,"We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types.","['advanced renal cell carcinoma', 'in advanced renal cell carcinoma (aRCC']","['Avelumab plus axitinib versus sunitinib', 'avelumab\u2009+\u2009axitinib versus sunitinib']",['prolonged progression-free survival (PFS'],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1700874', 'cui_str': 'axitinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0249677,"We identified important biological features associated with differential PFS between the treatment arms, including new immunomodulatory and angiogenesis gene expression signatures (GESs), previously undescribed mutational profiles and their corresponding GESs, and several HLA types.","[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA. motzerr@mskcc.org.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Robbins', 'Affiliation': 'Translational Oncology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': ""Department of Genitourinary Oncology, Barts Cancer Institute, Experimental Cancer Medicine Centre, Queen Mary University of London, St Bartholomew's Hospital, London, UK.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Haanen', 'Affiliation': 'Division of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Xinmeng Jasmine', 'Initials': 'XJ', 'LastName': 'Mu', 'Affiliation': 'Computational Biology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Ching', 'Affiliation': 'Computational Biology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Motohide', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Graduate School of Medicine, Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'Deputy Director for Science, Moscow Scientific Research Oncology Institute, Moscow, Russian Federation.'}, {'ForeName': 'Gwenaelle', 'Initials': 'G', 'LastName': 'Gravis', 'Affiliation': 'Department of Medical Oncology, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Campbell', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Penkov', 'Affiliation': 'Private Medical Institution, Euromedservice, St. Petersburg, Russian Federation.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Subramanian', 'Initials': 'S', 'LastName': 'Hariharan', 'Affiliation': 'Oncology, Pfizer, New York, NY, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Computational Biology, Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Biostatistics, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Chudnovsky', 'Affiliation': 'Oncology, Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'di Pietro', 'Affiliation': 'Immuno-Oncology, Pfizer, Milan, Italy.'}, {'ForeName': 'Amber C', 'Initials': 'AC', 'LastName': 'Donahue', 'Affiliation': 'Translational Oncology, Pfizer, La Jolla, CA, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': ""Department of Medical Oncology, The Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Boston, MA, USA. toni_choueiri@dfci.harvard.edu.""}]",Nature medicine,['10.1038/s41591-020-1044-8']
2130,32895647,Comparison of an Herbal- and a 0.12% Chlorhexidine-based Oral Rinse as Adjuncts to Nonsurgical Mechanical Debridement in the Management of Peri-implant Mucositis: A Randomised Controlled Trial.,"PURPOSE


In the present randomised controlled trial (RCT), the authors hypothesise that herbal-based oral rinses are as effective as 0.12% chlorhexidine when used as adjuncts to non-surgical mechanical debridement (MD) in the management of peri-implant mucositis. The aim of the present RCT was to compare the efficacy of an herbal oral rinse with a 0.12% chlorhexidine-based oral rinse when used as adjuncts to non-surgical MD in the treatment of peri-implant mucositis.
MATERIALS AND METHODS


Adult patients with peri-implant mucositis were included. Participants were randomly allocated into 3 groups. In group 1, patients only underwent non-surgical MD. In groups 2 and 3, patients underwent non-surgical MD with adjunct rinsing with an herbal- and 0.12% CHX-based oral rinse, respectively. Peri-implant plaque index (PI) and bleeding-on-probing (BOP) and probing-depth (PD) were assessed at baseline and at 3, 6, and 12 weeks. Group comparisons were done and p < 0.01 was considered statistically significant.
RESULTS


Forty-eight patients with peri-implant mucositis (16, 16, and 16 in groups 1, 2 and 3, respectively) were included. At baseline, there was no difference in PI, PD, BOP in all groups. In group 1, there was no statistically significant difference in PI and BOP at 6, and 12 weeks of follow-up compared with baseline. In groups 2 and 3, PI (p < 0.01) and BOP (p < 0.01) were statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up. In group 1, there was no statistically significant difference in PD at all time intervals. In groups 2 and 3, PD was statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up. In groups 2 and 3, there was no statistically significant difference in PI, BOP and PD at all intervals.
CONCLUSION


Herbal- and 0.12% CHX-based oral rinses are useful adjuncts to MD for the treatment of peri-implant mucositis.",2020,"In groups 2 and 3, PI (p < 0.01) and BOP (p < 0.01) were statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up.","['Peri-implant Mucositis', 'Forty-eight patients with peri-implant mucositis (16, 16, and 16 in groups 1, 2 and 3, respectively) were included', 'Adult patients with peri-implant mucositis were included']","['chlorhexidine-based oral rinse', 'herbal oral rinse', 'CHX-based oral rinses', 'Chlorhexidine-based Oral Rinse', 'chlorhexidine']","['PI, BOP and PD', 'PD', 'PI, PD, BOP', 'Peri-implant plaque index (PI) and bleeding-on-probing (BOP) and probing-depth (PD', 'PI and BOP', 'BOP']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",48.0,0.0257322,"In groups 2 and 3, PI (p < 0.01) and BOP (p < 0.01) were statistically significantly higher at baseline than 3, 6, and 12 weeks of follow-up.","[{'ForeName': 'Hamad', 'Initials': 'H', 'LastName': 'Alzoman', 'Affiliation': ''}, {'ForeName': 'Tariq Ghazi', 'Initials': 'TG', 'LastName': 'Alojaym', 'Affiliation': ''}, {'ForeName': 'Sandeepa Nuchilakath', 'Initials': 'SN', 'LastName': 'Chalikkandy', 'Affiliation': ''}, {'ForeName': 'Abid', 'Initials': 'A', 'LastName': 'Mehmood', 'Affiliation': ''}, {'ForeName': 'Fayza', 'Initials': 'F', 'LastName': 'Rashed', 'Affiliation': ''}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45069']
2131,32895660,Effect of Selenium on Incidence and Severity of Mucositis during Radiotherapy in Patients with Head and Neck Cancer.,"PURPOSE


Oral mucositis (OM) is the most frequent side effect of radiation. Selenium deficiency leads to increased levels of free oxygen radicals and the selenium level tends to fall during radiotherapy. Hence, in this double-blind randomised controlled clinical trial, the effect of selenium was assessed in patients receiving radiation.
MATERIALS AND METHODS


Patients with head and neck cancer who were candidates to receive radiation were instructed to use selenium 200 mcg tablets twice daily. The grade of OM was evaluated by the World Health Organization (WHO) grading system on a weekly basis. The selenium level was measured at baseline and at the end of the radiation.
RESULTS


Seventy-one patients with head and neck cancer (37 in the selenium group, 34 in the placebo group) were enrolled in the study. The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24) Conclusion: Selenium supplementation does not appear to affect the selenium level as well as the severity and duration of OM. It is supposed that higher doses may be effective in the prevention of RT-mucositis. This trial was registered in the Iranian Registry of Clinical Trials accessible at www.irct.ir (ID No. IRCT2014072718612N1).",2020,"The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24)","['patients receiving radiation', 'Seventy-one patients with head and neck cancer (37 in the selenium group, 34 in the placebo group) were enrolled in the study', 'Patients with Head and Neck Cancer', 'Patients with head and neck cancer who were candidates to receive radiation']","['Selenium supplementation', 'selenium 200 mcg tablets twice daily', 'Selenium', 'placebo', 'selenium']","['cumulative incidence of OM', 'grade of OM', 'Incidence and Severity of Mucositis', 'selenium level', 'mean serum selenium level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0373721', 'cui_str': 'Selenium measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455308', 'cui_str': 'Serum selenium measurement'}]",71.0,0.0814545,"The cumulative incidence of OM (grade 1-4) was 97.3% in the selenium and 100% in placebo group (p value: 0.79), and difference in the mean serum selenium level at the end of radiation was not statistically significant between the two groups (p value 0.24)","[{'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Laali', 'Affiliation': ''}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Manifar', 'Affiliation': ''}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kazemian', 'Affiliation': ''}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jahangard-Rafsanjani', 'Affiliation': ''}, {'ForeName': 'Kheirollah', 'Initials': 'K', 'LastName': 'Gholami', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45080']
2132,32895665,RDA and REA Values of Commercially Available Toothpastes Utilising Diamond Powder and Traditional Abrasives.,"PURPOSE


To investigate whether toothpastes with diamond powder vs those with traditional abrasives abrade dentin and enamel differently and to determine the relative dentin abrasivity (RDA) and relative enamel abrasivity (REA) values of those toothpastes.
MATERIALS AND METHODS


Dentin and enamel samples of bovine permanent incisors were randomly allocated into groups of eight, brushed with 20 different toothpastes (three of which contained diamond powder) and analysed for their RDA and REA values.
RESULTS


Toothpastes with diamond powder exhibit low RDA values but high REA values. Some RDA values exceeded the ones declared by the manufacturer.
CONCLUSION


Diamond powder as an abrasive might have a mild action on dentin, but it is highly abrasive on enamel.",2020,"RESULTS


Toothpastes with diamond powder exhibit low RDA values but high REA values.",['Dentin and enamel samples of bovine permanent incisors'],['toothpastes with diamond powder'],"['RDA and REA Values', 'relative dentin abrasivity (RDA) and relative enamel abrasivity (REA) values', 'RDA values']","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0032861', 'cui_str': 'Powder'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0175257,"RESULTS


Toothpastes with diamond powder exhibit low RDA values but high REA values.","[{'ForeName': 'Blend', 'Initials': 'B', 'LastName': 'Hamza', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Attin', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cucuzza', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gubler', 'Affiliation': ''}, {'ForeName': 'Florian J', 'Initials': 'FJ', 'LastName': 'Wegehaupt', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45085']
2133,32895744,Efficacy of surgical helmet systems for protection against COVID-19: a double-blinded randomised control study.,"PURPOSE


This study assesses whether sterile surgical helmet systems (SSHS) provide surgeons with additional protection from aerosol pathogens alongside their traditional role protecting against splash. There has been debate on whether to use such systems in reopening elective orthopaedic surgery during the current COVID-19 pandemic environment.
METHODS


Thirty-five participants were enrolled in a double-blinded randomised controlled study investigating efficacy of the Stryker Flyte Surgical Helmet (Stryker Corporation, Kalamazoo, MI, USA) as protection against respiratory droplets. Wearing the SSHS in a fit testing hood, subjects were randomised to nebulised saccharin solution or placebo. Twenty were allocated to the saccharin group with 15 to placebo. Positive sweet taste represented a failure of the test. Taste tests were performed with the helmet fan turned on and off.
RESULTS


SSHS did not prevent saccharin taste (p < 0.0001). Within the saccharin cohort, 40% recorded a positive taste with the fan on and 100% with the fan off. There was a statistically significant difference in mean time-to-taste saccharin (p = 0.049) comparing fan on (123.5 s) vs. off (62.6 s).
CONCLUSIONS


SSHS do not protect against aerosol particulate and therefore are not efficacious in protection against COVID-19. The fan system employed may even increase risk to the surgeon by drawing in particulates as well as delay recognition of intraoperative cues, such as exhaust from diathermy, that point to respirator mask leak.",2020,"There was a statistically significant difference in mean time-to-taste saccharin (p = 0.049) comparing fan on (123.5 s) vs. off (62.6 s).
",['Thirty-five participants'],"['saccharin', 'sterile surgical helmet systems (SSHS', 'surgical helmet systems', 'placebo', 'Stryker Flyte Surgical Helmet (Stryker Corporation, Kalamazoo, MI, USA', 'nebulised saccharin solution or placebo']","['saccharin taste', 'mean time-to-taste saccharin']","[{'cui': 'C4319605', 'cui_str': '35'}]","[{'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0180797', 'cui_str': 'Surgical helmet system'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0036023', 'cui_str': 'Saccharin'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",35.0,0.464993,"There was a statistically significant difference in mean time-to-taste saccharin (p = 0.049) comparing fan on (123.5 s) vs. off (62.6 s).
","[{'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Schaller', 'Affiliation': 'Trauma and Orthopaedics Department, Whittington Health NHS Trust, Magdala Avenue, London, N19 5NF, UK. Gavin.schaller@nhs.net.'}, {'ForeName': 'Sandeep Krishan', 'Initials': 'SK', 'LastName': 'Nayar', 'Affiliation': 'Trauma and Orthopaedics Department, Whittington Health NHS Trust, Magdala Avenue, London, N19 5NF, UK.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Erotocritou', 'Affiliation': 'Trauma and Orthopaedics Department, Whittington Health NHS Trust, Magdala Avenue, London, N19 5NF, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Overton', 'Affiliation': 'Trauma and Orthopaedics Department, Whittington Health NHS Trust, Magdala Avenue, London, N19 5NF, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stelzhammer', 'Affiliation': 'Trauma and Orthopaedics Department, Whittington Health NHS Trust, Magdala Avenue, London, N19 5NF, UK.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Berber', 'Affiliation': 'Trauma and Orthopaedics Department, Whittington Health NHS Trust, Magdala Avenue, London, N19 5NF, UK.'}]",International orthopaedics,['10.1007/s00264-020-04796-3']
2134,32895767,"Association between dental conditions, sliver diamine fluoride application, parental satisfaction, and oral health-related quality of life of preschool children.","OBJECTIVES


To investigate the associations between dental conditions, sliver diamine fluoride (SDF) application, parental satisfaction, and oral health-related quality of life (OHRQoL) of preschool children.
MATERIALS AND METHODS


In a clinical trial conducted in Hong Kong, preschool children who had carious lesions into dentine were randomly assigned to receive an application of SDF solution or placebo on their caries lesions 10 weeks before they received restorations. Additionally, a random sample of caries-free children was also recruited. Parents of the study children rated their satisfaction with their child's teeth using a 5-point scale (5 = very satisfied, 1 = very dissatisfied) 10 weeks after SDF or placebo application. Besides, the Chinese version of the Early Childhood Oral Health Impact Scale (C-ECOHIS) was used to assess the children's OHRQoL.
RESULTS


There were 127, 133, and 154 children in the SDF, placebo, and caries-free groups, respectively. The parents whose child had 4 or more decayed teeth reported lower satisfaction scores (mean = 2.0 ± 0.7) with their child's dental health status compared with those of parents whose child had fewer (mean = 2.6 ± 0.9) or no (mean = 3.7 ± 0.7) decayed teeth (p < 0.001). These parents also reported higher C-ECOHIS scores. However, there was no significant difference in parental satisfaction and children's OHRQoL between the SDF and placebo groups (p > 0.05).
CONCLUSIONS


In this study population, parental satisfaction and children's OHRQoL were associated with children's dental caries status but not with SDF application.
CLINICAL RELEVANCE


This study provides valuable information about the factors, including SDF application, that can influence parental satisfaction and OHRQoL of preschool children.",2020,"However, there was no significant difference in parental satisfaction and children's OHRQoL between the SDF and placebo groups (p > 0.05).
","['preschool children', 'preschool children who had carious lesions into dentine']",['SDF solution or placebo'],"[""parental satisfaction and children's OHRQoL"", 'sliver diamine fluoride (SDF) application, parental satisfaction, and oral health-related quality of life (OHRQoL', 'satisfaction scores']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011957', 'cui_str': 'Diamine'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011957', 'cui_str': 'Diamine'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.229029,"However, there was no significant difference in parental satisfaction and children's OHRQoL between the SDF and placebo groups (p > 0.05).
","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Qiu Yan', 'Initials': 'QY', 'LastName': 'Xie', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Hung', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China. edward-lo@hku.hk.'}]",Clinical oral investigations,['10.1007/s00784-020-03542-8']
2135,32895855,"An Innovative Pharmacometric Approach for the Simultaneous Analysis of Frequency, Duration and Severity of Migraine Events.","PURPOSE


To explore the use of a multistate repeated, time-to-categorical event model describing the frequency, severity and duration of migraines.
METHODS


Subject level data from patients in placebo arms from two efficacy trials for migraine-preventive treatments were used. Models were developed using NONMEM 7.3. A survival model was combined with an ordered categorical model to form the repeated-time-to-start of categorical migraine event model, which simultaneously described the time-to-start of migraines and the severity of the starting migraine event. This was linked to a repeated-time-to-end of migraine event model with different hazard functions depending on the severity of the ongoing migraine event. Model performance was internally and externally qualified.
RESULTS


The successfully qualified model showed that patients responding to placebo had a reduction in migraine incidence rate, and a decreased proportion of severe migraines. There was an increase in moderate migraine duration, an increased proportion of mild migraines and a reduction in proportion of severe migraines. Age was related to migraine duration.
CONCLUSIONS


The model represents an innovative framework for clinical trial modeling and simulation, and successfully describes placebo effect in migraine prevention. This approach can be adapted to investigate exposure-response relationship of drugs and can also be implemented in other therapeutic areas where the rate, duration and severity of disease episodes are relevant to trial outcomes.",2020,"There was an increase in moderate migraine duration, an increased proportion of mild migraines and a reduction in proportion of severe migraines.",['Subject level data from patients in'],['placebo'],"['proportion of severe migraines', 'moderate migraine duration', 'mild migraines', 'migraine incidence rate']","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0438345,"There was an increase in moderate migraine duration, an increased proportion of mild migraines and a reduction in proportion of severe migraines.","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Perez-Pitarch', 'Affiliation': 'Division of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.'}, {'ForeName': 'Gopichand', 'Initials': 'G', 'LastName': 'Gottipati', 'Affiliation': 'Division of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Uppoor', 'Affiliation': 'Division of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Division of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.'}, {'ForeName': 'Sreedharan', 'Initials': 'S', 'LastName': 'Sabarinath', 'Affiliation': 'Division of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA. Sreedharan.Sabarinath@fda.hhs.gov.'}]",Pharmaceutical research,['10.1007/s11095-020-02907-8']
2136,32895874,Efficacy of oral rosuvastatin intervention on HDL and its associated proteins in men with type 2 diabetes mellitus.,"PURPOSE


High-density lipoprotein (HDL) undergoes structural and functional modification in patients with type 2 diabetes mellitus (T2DM). There are limited data on effect of rosuvastatin on HDL-associated proteins and the antiatherogenic effects of rosuvastatin. The present study intended to study the efficacy of rosuvastatin intervention on HDL-associated proteins and its other antiatherogenic effects in men with T2DM.
METHODS


Men with T2DM on oral antidiabetic treatment, with LDL-C levels > 75 mg/dL and willing for rosuvastatin intervention (20 mg/day orally for a period of 12 weeks), were included. Fasting glucose, lipid profile were measured using standard methods. Oxidized low-density lipoprotein (oxLDL), oxidized HDL (oxHDL), paraoxonase-1 (PON-1), tumour necrosis factor-α (TNF-α) and lecithin:cholesterol acyltransferase (LCAT) in serum were measured by ELISA; serum myeloperoxidase (MPO) by spectrophotometric method and cholesterol efflux by fluorometric assay. Carotid intima-media thickness (cIMT) measurement to assess vascular health status was done using doppler.
RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up. A decrease in MPO activity was found to be independently associated with an increase in cholesterol efflux.
CONCLUSIONS


Post intervention there is a quantitative and qualitative improvement in HDL, which helps in its reverse cholesterol transport (RCT) and antioxidant functions. Improvement in HDL functions and suppression of inflammation by rosuvastatin lead to regression in cIMT, which is beneficial in decreasing the progression of cardiovascular disease (CVD) in men with diabetes.",2020,"RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up.","['men with diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'men with type 2 diabetes mellitus', 'Men with T2DM on oral antidiabetic treatment, with LDL-C levels\u2009', 'men with T2DM']","['Carotid intima-media thickness (cIMT) measurement', 'Rosuvastatin', 'rosuvastatin', 'rosuvastatin intervention', 'oral rosuvastatin intervention']","['antiatherogenic HDL and cholesterol efflux', 'MPO activity', 'Fasting glucose, lipid profile', 'cholesterol efflux', 'Oxidized low-density lipoprotein (oxLDL), oxidized HDL (oxHDL), paraoxonase-1', 'PON-1), tumour necrosis factor-α (TNF-α) and lecithin:cholesterol acyltransferase (LCAT) in serum', 'lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C1121571', 'cui_str': 'Paraoxonase 1'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0031617', 'cui_str': 'Lecithin'}, {'cui': 'C0008380', 'cui_str': 'Cholesterol acyltransferase'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0204753,"RESULTS


Rosuvastatin produced a significant decrease (p < 0.05) in lipids (total cholesterol, triglycerides, LDL-C); oxidative stress (oxLDL, oxHDL, MPO); inflammation (TNF-α); LCAT concentration; cIMT; significant increase in antiatherogenic HDL and cholesterol efflux (p < 0.05) and no change in apoA-I levels from baseline to 12 weeks of follow-up.","[{'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Naresh', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Aparna R', 'Initials': 'AR', 'LastName': 'Bitla', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India. aparnabitla@yahoo.co.in.'}, {'ForeName': 'P V L N Srinivasa', 'Initials': 'PVLNS', 'LastName': 'Rao', 'Affiliation': 'Department of Biochemistry, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Alok', 'Initials': 'A', 'LastName': 'Sachan', 'Affiliation': 'Department of Endocrinology and Metabolism, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}, {'ForeName': 'Yadagiri Lakshmi', 'Initials': 'YL', 'LastName': 'Amancharla', 'Affiliation': 'Department of Radiology, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, 517507, India.'}]",Endocrine,['10.1007/s12020-020-02472-5']
2137,32895879,Modelling the cost-effectiveness of person-centred care for patients with acute coronary syndrome.,"BACKGROUND


Person-centred care has been shown to be cost-effective compared to usual care for several diseases, including acute coronary syndrome, in a short-term time perspective (< 2 years). The cost-effectiveness of person-centred care in a longer time perspective is largely unknown.
OBJECTIVES


To estimate the mid-term cost-effectiveness of person-centred care compared to usual care for patients (< 65) with acute coronary syndrome, using a 2-year and a 5-year time perspective.
METHODS


The mid-term cost-effectiveness of person-centred care compared to usual care was estimated by projecting the outcomes observed in a randomized-controlled trial together with data from health registers and data from the scientific literature, 3 years beyond the 2-year follow-up, using the developed simulation model. Probabilistic sensitivity analyses were performed using Monte Carlo simulation.
RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective. Monte Carlo simulations suggest that the likelihoods of the person-centred care being cost-effective compared to usual care were between 80 and 99% and between 75 and 90% for a 2-year and a 5-year time perspective (using a 500,000 SEK/QALY willingness-to-pay threshold).
CONCLUSIONS


Person-centred care was less costly and more effective compared to usual care in a 2-year and a 5-year time perspective for patients with acute coronary syndrome under the age of 65.",2020,"RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective.","['patients (<\u200965) with acute coronary syndrome, using a 2-year and a 5-year time perspective', 'patients with acute coronary syndrome', 'patients with acute coronary syndrome under the age of 65']",['person-centred care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040226', 'cui_str': 'Time Perception'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],,0.0392597,"RESULTS


Person-centred care entails lower costs and improved effectiveness as compared to usual care, for a 2-year time and a 5-year perspective.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pirhonen', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden. laura.pirhonen@economics.gu.se.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gyllensten', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Box 457, 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Bolin', 'Affiliation': 'Centre for Health Economics (CHEGU), Department of Economics, University of Gothenburg, Gothenburg, Sweden.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-020-01230-8']
2138,32895890,A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool.,"BACKGROUND


The effectiveness of computer-based cognitive training (CCT) remains controversial, especially in older adults with neurodegenerative diseases.
AIMS


To evaluate the efficacy of CCT in patients with Parkinson's disease and mild cognitive impairment (PD-MCI).
METHODS


In this randomized controlled trial, 53 patients were randomized to receive CCT delivered by means of CoRe software, traditional paper-and-pencil cognitive training (PCT), or an unstructured activity intervention (CG). In each group, the intervention lasted 3 consecutive weeks (4 individual face-to-face sessions/week). Neuropsychological assessment was administered at baseline (T0) and post-intervention (T1). Outcome measures at T0 and T1 were compared within and between groups. The Montreal Overall Cognitive Assessment (MoCA) was taken as the primary outcome measure.
RESULTS


Unlike the PCT group and the CG, the patients receiving CCT showed significant medium/large effect size improvements in MoCA performance, global cognition, executive functions, and attention/processing speed. No baseline individual/demographic variables were associated with greater gains from the intervention, although a negative correlation with baseline MoCA performance was found.
CONCLUSION


CCT proved effective in PD-MCI patients when compared with traditional PCT. Further follow-up assessments are being conducted to verify the retention of the gains and the potential ability of the tool to delay conversion to PD-dementia. Trial registration number (ClinicalTrials.gov): NCT04111640 (30th September 2019).",2020,", the patients receiving CCT showed significant medium/large effect size improvements in MoCA performance, global cognition, executive functions, and attention/processing speed.","['53 patients', 'older adults with neurodegenerative diseases', ""patients with Parkinson's disease and mild cognitive impairment (PD-MCI"", ""mild cognitive impairment in Parkinson's disease""]","['CG', 'PCT', 'cognitive training', 'CCT delivered by means of CoRe software, traditional paper-and-pencil cognitive training (PCT), or an unstructured activity intervention (CG', 'computer-based cognitive training (CCT', 'CCT']","['Montreal Overall Cognitive Assessment (MoCA', 'MoCA performance, global cognition, executive functions, and attention/processing speed']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0524851', 'cui_str': 'Neurodegenerative disorder'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",53.0,0.114417,", the patients receiving CCT showed significant medium/large effect size improvements in MoCA performance, global cognition, executive functions, and attention/processing speed.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bernini', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy. sara.bernini@mondino.it.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Panzarasa', 'Affiliation': 'Dept. of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sinforiani', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Quaglini', 'Affiliation': 'Dept. of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bottiroli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}]",Aging clinical and experimental research,['10.1007/s40520-020-01665-2']
2139,32895969,The Effect of a Preoperative Home-delivered Protein-rich Meal Service to Improve Protein Intake in Surgical Patients: A Randomized Controlled Trial.,"BACKGROUND


The preoperative period likely provides an important opportunity to improve postoperative recovery as suggested by the finding that low nutritional status is a predictor of increased postoperative complications and longer length of stay. It was investigated whether a home-delivered protein-rich meal service improves protein intake relative to requirements within 3 weeks prior to surgery compared to usual care.
METHODS


A randomized controlled trial in adults with planned surgery was performed at the Orthopedics, Urology, Gynecology or General Surgery department were included (n = 126). The intervention group received six protein-rich dishes per day for 3 weeks and the control group sustained their usual diet. Dietary intake, nutritional status, hand grip strength, physical performance and quality of life were assessed at baseline and after 3 weeks. Patient satisfaction was reported after 3 weeks and data on complications and length of stay 30 days after surgery.
RESULTS


Protein intake relative to requirements significantly improved by 16% and energy intake relative to requirements by 19% for the meal service compared to usual care. The intervention group experienced significantly less stress with preparing meals and were more satisfied with the presentation of the meals than the control group. No significant effects of the intervention were detected on other secondary outcomes.
CONCLUSION


The home-delivered protein-rich meal service was successfully implemented before surgery and improves protein and energy intake relative to requirements within 3 weeks while patient satisfaction maintained. The preoperative period serves as a window of opportunity to prepare patients before hospitalization. This article is protected by copyright. All rights reserved.",2020,The intervention group experienced significantly less stress with preparing meals and were more satisfied with the presentation of the meals than the control group.,"['adults with planned surgery was performed at the Orthopedics, Urology, Gynecology or General Surgery department were included (n = 126', 'Surgical Patients']","['six protein-rich dishes per day for 3 weeks and the control group sustained their usual diet', 'Preoperative Home-delivered Protein-rich Meal Service']","['Dietary intake, nutritional status, hand grip strength, physical performance and quality of life', 'Patient satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444661', 'cui_str': 'Protein-rich meal'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",126.0,0.0504278,The intervention group experienced significantly less stress with preparing meals and were more satisfied with the presentation of the meals than the control group.,"[{'ForeName': 'Vera E', 'Initials': 'VE', 'LastName': 'IJmker-Hemink', 'Affiliation': 'Department of Gastroenterology and Hepatology - Dietetics and Intestinal Failure, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Geert J A', 'Initials': 'GJA', 'LastName': 'Wanten', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Lindsey C F', 'Initials': 'LCF', 'LastName': 'de Nes', 'Affiliation': 'Department of Surgery, Maasziekenhuis Pantein, Beugen, The Netherlands.'}, {'ForeName': 'Manon G A', 'Initials': 'MGA', 'LastName': 'van den Berg', 'Affiliation': 'Department of Gastroenterology and Hepatology - Dietetics and Intestinal Failure, Radboud University Medical Centre, Nijmegen, The Netherlands.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2015']
2140,32895971,"Efficacy and Safety of Enteral Erythromycin Estolate in Combination with Intravenous Metoclopramide versus Intravenous Metoclopramide Monotherapy in Mechanically Ventilated Patients with Enteral Feeding Intolerance: A Randomized, Double-blind Controlled Pilot Study.","BACKGROUND


This pilot study aimed to determine the efficacy and safety of enteral erythromycin estolate in combination with intravenous metoclopramide compared to intravenous metoclopramide monotherapy in mechanically ventilated patients with enteral feeding intolerance.
METHODS


This randomized, double-blind, controlled pilot study included 35 mechanically ventilated patients with feeding intolerance randomized to receive 10 mg metoclopramide intravenously every 6-8 h in combination with 250 mg enteral erythromycin estolate (study group) or placebo every 6 h for seven days. The primary outcome was an administered/target calorie ratio of ≥80% at 48 h, indicating a successful feeding. Secondary prespecified outcomes were daily average gastric residual volume (GRV), total caloric intake, administered/target calorie ratio, hospital length of stay, in-hospital mortality, and 28-day mortality.
RESULTS


The rate of successful feeding was not significantly different between the study and placebo groups (47.1% and 61.1%, respectively; p = 0.51). The average daily GRV was significantly lower in the study group than in the placebo group (B-coefficient -91.58 (95% Wald CI: -164.35 to -18.8) determined by generalized estimating equation. Other secondary outcomes were comparable, and the incidence of adverse events was not significantly different between the two groups. One common complication was cardiac arrhythmia, which was mostly self-terminated.
CONCLUSION


Although the combination therapy of enteral erythromycin estolate and intravenous metoclopramide reduced GRV, the successful feeding rate and other patient-specific outcomes did not improve in mechanically ventilated patients with feeding intolerance. This article is protected by copyright. All rights reserved.",2020,The average daily GRV was significantly lower in the study group than in the placebo group (B-coefficient -91.58,"['mechanically ventilated patients with feeding intolerance', 'mechanically ventilated patients with enteral feeding intolerance', 'Mechanically Ventilated Patients with Enteral Feeding Intolerance', '35 mechanically ventilated patients with feeding intolerance']","['enteral erythromycin estolate', 'metoclopramide intravenously every 6-8 h in combination with 250 mg enteral erythromycin estolate', 'Metoclopramide', 'placebo', 'Enteral Erythromycin Estolate', 'Metoclopramide Monotherapy', 'metoclopramide', 'metoclopramide monotherapy']","['rate of successful feeding', 'Efficacy and Safety', 'average daily GRV', 'incidence of adverse events', 'daily average gastric residual volume (GRV), total caloric intake, administered/target calorie ratio, hospital length of stay, in-hospital mortality, and 28-day mortality', 'target calorie ratio of ≥80% at 48 h, indicating a successful feeding']","[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0014809', 'cui_str': 'Erythromycin estolate'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}]",35.0,0.627337,The average daily GRV was significantly lower in the study group than in the placebo group (B-coefficient -91.58,"[{'ForeName': 'Taniya', 'Initials': 'T', 'LastName': 'Charoensareerat', 'Affiliation': 'Faculty of Pharmacy, Siam University, Bangkok, Thailand.'}, {'ForeName': 'Rungsun', 'Initials': 'R', 'LastName': 'Bhurayanontachai', 'Affiliation': 'Critical Care Medicine Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand.'}, {'ForeName': 'Sirima', 'Initials': 'S', 'LastName': 'Sitaruno', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Navasakulpong', 'Affiliation': 'Respiratory and Respiratory Critical Care Medicine Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Boonpeng', 'Affiliation': 'School of Pharmaceutical Sciences, University of Phayao, Phayao, Thailand.'}, {'ForeName': 'Sanguan', 'Initials': 'S', 'LastName': 'Lerkiatbundit', 'Affiliation': 'Department of Pharmacy Administration, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Sutthiporn', 'Initials': 'S', 'LastName': 'Pattharachayakul', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Songkhla, Thailand.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.2013']
2141,32895995,Editorial Comment to Coverage of the external prostatic region by the hybrid method compared with the conventional method of prostate low-dose-rate brachytherapy: A randomized controlled study.,,2020,,[],['conventional method of prostate low-dose-rate brachytherapy'],[],[],"[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}]",[],,0.026038,,"[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Department of Urology, Showa University Koto Toyosu Hospital, Tokyo, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14370']
2142,32896000,Clinical influence of calcium hydroxide and N-acetylcysteine on the levels of resolvins E1 and D2 in apical periodontitis.,"AIM


To investigate the presence of resolvins E1 (RvE1) and D2 (RvD2) in teeth with primary endodontic infection and apical periodontitis, and to assess the influence of calcium hydroxide medication [Ca(OH) 2  ], in association with 2% chlorhexidine gel (2% CHX gel), and N-acetylcysteine (NAC) on the levels of RvE1 and RvD2 and in periapical tissues.
METHODOLOGY


Thirty-six single-rooted teeth with primary endodontic infections and apical periodontitis were selected and randomly divided into three groups according to the medication: [Ca(OH) 2  ]+ saline solution (SSL) [Ca(OH) 2  + SSL group] (n=12), Ca(OH) 2  + 2% chlorhexidine gel [Ca(OH) 2  + 2% CHX gel group] (n=12), and NAC [NAC group] (n=12). Samples were collected from the periapical interstitial fluid at two different sampling times: before (S1) and after 14 days of intracanal medications (S2). Resolvins were measured using the enzyme-linked immunosorbent assay. Data were analysed using paired t-test, Wilcoxon test, and Kruskal-Wallis test, followed by Dunn's post hoc test, all statistical tests were performed at a significance level of 5%.
RESULTS


RvE1 and RvD2 were detected in 100% of the samples (36/36) at S1 and S2. Ca(OH) 2  medication did not increase the levels of RvE1 or RvD2 (both p>0.05); however, NAC significantly increased the levels of RvE1 and RvD2 after 14 days of treatment (p<0.05).
CONCLUSIONS


RvE1 and RvD2 were detected in periapical tissues from teeth with root canal infections. Moreover, calcium hydroxide medication did not increase the levels of resolvins in apical periodontitis. In contrast, the use of NAC intracanal medication significantly increased the levels of RvE1 and RvD2 after 14 days of treatment.",2020,"2  medication did not increase the levels of RvE1 or RvD2 (both p>0.05); however, NAC significantly increased the levels of RvE1 and RvD2 after 14 days of treatment (p<0.05).
","['teeth with primary endodontic infection and apical periodontitis', 'Thirty-six single-rooted teeth with primary endodontic infections and apical periodontitis']","['calcium hydroxide medication', 'resolvins E1 (RvE1) and D2 (RvD2', 'chlorhexidine gel (2% CHX gel), and N-acetylcysteine (NAC', 'Ca(OH', 'medication: [Ca(OH) 2  ]+ saline solution (SSL', 'calcium hydroxide and N-acetylcysteine', 'NAC [NAC', 'chlorhexidine gel [Ca(OH) 2  + 2% CHX gel']","['RvE1 and RvD2', 'levels of RvE1 and RvD2', 'levels of RvE1 or RvD2', 'levels of RvE1 and RvD2 and in periapical tissues', 'levels of resolvins in apical periodontitis', 'levels of resolvins E1 and D2 in apical periodontitis']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1568094', 'cui_str': '5S,12R,18R-trihydroxy-6Z,8E,10E,14Z,16E-eicosapentaenoic acid'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}]","[{'cui': 'C1568094', 'cui_str': '5S,12R,18R-trihydroxy-6Z,8E,10E,14Z,16E-eicosapentaenoic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031033', 'cui_str': 'Structure of periapical tissue'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}]",,0.0182351,"2  medication did not increase the levels of RvE1 or RvD2 (both p>0.05); however, NAC significantly increased the levels of RvE1 and RvD2 after 14 days of treatment (p<0.05).
","[{'ForeName': 'Bjm', 'Initials': 'B', 'LastName': 'Corazza', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Martinho', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, School of Dentistry, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Khoury', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Toia', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'Eif', 'Initials': 'E', 'LastName': 'Orozco', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': 'Prado', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Machado', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Valera', 'Affiliation': 'Department of Restorative Dentistry, Endodontic Division, São Paulo State University - UNESP, Institute of Science and Technology, São José dos Campos, São Paulo, Brazil.'}]",International endodontic journal,['10.1111/iej.13403']
2143,32896014,"Patient-centred, self-administered acupressure for Chinese advanced cancer patients experiencing fatigue and co-occurring symptoms: A pilot randomised controlled trial.","OBJECTIVES


To evaluate the feasibility and potential effects of patient-centred self-administered acupressure for alleviating fatigue and co-occurring symptoms among Chinese advanced cancer patients receiving treatment.
METHODS


Thirty advanced cancer patients who screened positive for moderate/severe fatigue with symptoms of insomnia and/or pain were recruited from a hospital in Hong Kong. They were randomly assigned (1:1) to receive a 4-week patient-centred self-administered acupressure intervention or health education. Fatigue (primary outcome) and secondary outcomes (sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, anxiety, depression and quality of life) were measured by questionnaires and actigraphy.
RESULTS


Twenty-four participants (80%) completed the study. Adherence to self-administered acupressure practice was satisfactory, with all retained participants attending all sessions and 90.9% practising acupressure daily. All completers rated the class as very enjoyable or quite enjoyable. Fatigue, pain, symptom cluster severity, anxiety, depression and quality of life appeared to improve from baseline to post-intervention in the intervention group. Among these outcomes, only the between-group difference in anxiety post-intervention was significant. The group × time interaction effect was nonsignificant for all outcomes.
CONCLUSIONS


Patient-centred self-administered acupressure appears to be feasible and acceptable among advanced cancer patients. A fully powered trial is warranted to confirm the intervention effect.",2020,"Fatigue, pain, symptom cluster severity, anxiety, depression and quality of life appeared to improve from baseline to post-intervention in the intervention group.","['Twenty-four participants (80%) completed the study', 'Chinese advanced cancer patients experiencing fatigue and co-occurring symptoms', 'advanced cancer patients', 'Chinese advanced cancer patients receiving treatment', 'Thirty advanced cancer patients who screened positive for moderate/severe fatigue with symptoms of insomnia and/or pain were recruited from a hospital in Hong Kong']","['acupressure', 'patient-centred self-administered acupressure', '4-week patient-centred self-administered acupressure intervention or health education']","['anxiety post-intervention', 'Fatigue, pain, symptom cluster severity, anxiety, depression and quality of life', 'Fatigue (primary outcome) and secondary outcomes (sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, anxiety, depression and quality of life']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]",30.0,0.10377,"Fatigue, pain, symptom cluster severity, anxiety, depression and quality of life appeared to improve from baseline to post-intervention in the intervention group.","[{'ForeName': 'Denise Shuk Ting', 'Initials': 'DST', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wing Fai', 'Initials': 'WF', 'LastName': 'Yeung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Pui Hing', 'Initials': 'PH', 'LastName': 'Chau', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai Chung', 'Initials': 'TC', 'LastName': 'Lam', 'Affiliation': 'Department of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Mingxiao', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kithelia', 'Initials': 'K', 'LastName': 'Lai', 'Affiliation': 'Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Chun Yat', 'Initials': 'CY', 'LastName': 'Ip', 'Affiliation': 'Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chia-Chin', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}]",European journal of cancer care,['10.1111/ecc.13314']
2144,32896022,Effects of Panax quinquefolius (American ginseng) on the steady state visually evoked potential during cognitive performance.,"OBJECTIVE


To investigate the effects of acute Panax quinquefolius (American ginseng) administration on steady state visually evoked potentials (SSVEPs) during completion of working memory and continuous performance tasks.
METHODS


A randomised, double-blind, placebo controlled, balanced, cross-over trial was conducted in middle-aged volunteers aged between 40 and 60 years. Participants were administered 200 mg P. quinquefolius and placebo on two separate testing sessions. Six-h post-dose participants completed spatial working memory (SWM) and continuous performance (CP) tasks while SSVEP from a diffuse task-irrelevant 13 Hz flicker was recorded.
RESULTS


During SWM retrieval, P. quinquefolius was associated with significantly reduced prefrontal SSVEP latency. There were no significant treatment effects on CP nor behavioural performance of either task.
CONCLUSIONS


These findings provide preliminary evidence of increased recruitment of prefrontal brain regions during working memory processing following a single acute dose of P. quinquefolius.",2020,"There were no significant treatment effects on CP nor behavioural performance of either task.
",['middle-aged volunteers aged between 40 and 60 years'],"['quinquefolius and placebo', 'acute Panax quinquefolius (American ginseng', 'placebo', 'Panax quinquefolius (American ginseng']","['CP nor behavioural performance of either task', 'spatial working memory (SWM) and continuous performance (CP) tasks', 'prefrontal SSVEP latency', 'steady state visually evoked potentials (SSVEPs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",,0.434369,"There were no significant treatment effects on CP nor behavioural performance of either task.
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, Victoria, Australia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Camfield', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ossoukhova', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Savage', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Le Cozannet', 'Affiliation': 'Naturex Part of Givaudan, Avignon, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fança-Berthon', 'Affiliation': 'Naturex Part of Givaudan, Avignon, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Scholey', 'Affiliation': 'Centre for Human Psychopharmacology, Swinburne University, Melbourne, Victoria, Australia.'}]",Human psychopharmacology,['10.1002/hup.2756']
2145,32896089,Effect of behavioral intervention on medication adherence among elderly with select non-communicable diseases (ENDORSE): Pilot randomized controlled trial.,"AIM


Adherence to medication is important in older patients with non-communicable diseases, and there is a need to investigate various interventions to enhance adherence in our Indian setting. This pilot randomized controlled trial aimed at testing the effectiveness of systematic education and behavioral intervention in enhancing medication adherence among older adults.
METHODS


It was a single center, open label, parallel arm, randomized controlled trial carried out among older (age >60 years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease. Participants were randomized either to receive the usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders. Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period. The primary end-points were change in the reported pill count (RPC) within groups and between groups at the third and sixth month.
RESULTS


The RPC in control and intervention arms at the thrid month were 78.20% and 91.88% (P = 0.007), whereas at 6 months they were 68.64% and 83.08% (P = 0.003), respectively. Similarly, change in RPC in intervention arm between baseline and the third month (mean difference 24.08%, P = 0.001), and between baseline and the sixth month (mean difference 15.280%, P = 0.006) were statistically significant. However, the RPC between the third and sixth month showed a significant decline (mean difference 8.8%, P = 0.016).
CONCLUSION


In this pilot study, we prove that behavioral interventions have improved medication adherence among older adults, and it is feasible to carry out such studies among older adults in India. Geriatr Gerontol Int 2020; ••: ••-••.",2020,Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period.,"['older adults', 'elderly with select non-communicable diseases (ENDORSE', 'older patients with non-communicable diseases', 'older adults in India', 'older (age >60\u2009years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease']","['behavioral interventions', 'usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders', 'systematic education and behavioral intervention', 'behavioral intervention']","['change in RPC', 'pill count (RPC', 'medication adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0561124,Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period.,"[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Raj', 'Affiliation': ""Department of Pharmacology, St. John's Medical College, Bengaluru, India.""}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Mathews', 'Affiliation': ""Division of Geriatrics, Department of Medicine, St. John's Medical College, Bengaluru, India.""}]",Geriatrics & gerontology international,['10.1111/ggi.14032']
2146,32896158,The Effect of Anonymous Computer-Mediated Communication on State Anxiety: An Experimental Study.,"This study examined the effect of anonymous computer-mediated communication (CMC) on state anxiety, specifically focusing on whether the valence of the interaction affected state anxiety before completing an anxiety-inducing task. Sixty-two female participants aged 18-25 were randomly assigned to one of three conditions: positive CMC, negative CMC, and blog. Self-report measures of state anxiety were taken at baseline; after participants had been given instructions about the anxiety-inducing task; after 10 minutes of CMC/blog writing; and after the anxiety-inducing task had been completed. Results showed that participants in the positive CMC condition showed a significant and moderate decrease in anxiety following the CMC, whereas those in the negative CMC condition showed a nonsignificant but moderate increase in anxiety following the CMC. Anxiety remained relatively unaffected by the blog condition. After completing the anxiety-inducing task, there were no differences in anxiety scores between groups. The findings show that CMC can be beneficial for relieving state anxiety, but the valence of the communication is crucial. This has implications for advice and training given to those participating in and supporting CMC where mental health issues might be discussed.",2020,Anxiety remained relatively unaffected by the blog condition.,"['Sixty-two female participants aged 18-25', 'State Anxiety']","['anonymous computer-mediated communication (CMC', 'positive CMC, negative CMC, and blog', 'Anonymous Computer-Mediated Communication', 'CMC']","['state anxiety', 'anxiety scores', 'Anxiety', 'anxiety']","[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",62.0,0.0162615,Anxiety remained relatively unaffected by the blog condition.,"[{'ForeName': 'Joshua A B', 'Initials': 'JAB', 'LastName': 'Littler', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Haffey', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Wake', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}, {'ForeName': 'Helen F', 'Initials': 'HF', 'LastName': 'Dodd', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, United Kingdom.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2020.0213']
2147,32896172,Communicating Oncologic Prognosis With Empathy: A Pilot Study of a Novel Communication Guide.,"BACKGROUND


Clear communication between patients, families, and health-care providers is imperative to maximize patient outcomes, particularly for patients diagnosed with incurable cancer who require prompt engagement in decision-making. In response to the need to engage in quality patient-centered communication, an interprofessional team, representing medicine, nursing, social work, spiritual care, and clinical psychology, explored extant literature and developed a simple, single-page communication guide that summarizes the prognosis for patients with incurable cancers. The tool was specifically designed to enhance communication for patients, families, and across all members of the treatment and patient support team.
PURPOSE


The purpose of this pilot study was to evaluate the impact of the communication guide on patient's accurate understanding of prognosis and the feasibility and acceptability of the intervention.
METHODS


The study employed a sequential explanatory mixed-method design. Using pre- and post-tests, participants completed a prognosis and treatment perception survey and were randomized into control or intervention groups based on preference for prognostic information. The oncologist utilized the communication guide with the participants in the intervention group. Finally, 6-week post-test surveys were completed, followed by an exit interview.
RESULTS


Key findings revealed participants prefer receiving detailed information about prognosis and have differing perceptions compared to the oncologists. Understandings of prognosis for patients and oncologists became more congruent following use of the communication guide. Participants found the tool useful and helpful.
CONCLUSIONS


The communication tool serves as a promising mechanism to enhance patient-centered communication about prognosis for patients with incurable cancer.",2020,"The tool was specifically designed to enhance communication for patients, families, and across all members of the treatment and patient support team.
","['patients with incurable cancers', 'patients with incurable cancer', 'patients diagnosed with incurable cancer who require prompt engagement in decision-making', 'participants completed a prognosis and treatment perception survey']",['Empathy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}]",[],,0.0379037,"The tool was specifically designed to enhance communication for patients, families, and across all members of the treatment and patient support team.
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Lippe', 'Affiliation': '8063University of Alabama Capstone College of Nursing, Tuscaloosa, AL, USA.'}, {'ForeName': 'Phillips', 'Initials': 'P', 'LastName': 'Farya', 'Affiliation': '12330University of Texas Steve Hicks School of Social Work, Austin, TX, USA.'}, {'ForeName': 'McCulloch', 'Initials': 'M', 'LastName': 'Jennifer', 'Affiliation': '3447Colorado State University School of Social Work, Fort Collins, CO, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Stanley', 'Affiliation': '8063University of Alabama Capstone College of Nursing, Tuscaloosa, AL, USA.'}, {'ForeName': 'Jones', 'Initials': 'J', 'LastName': 'Barbara', 'Affiliation': '12330University of Texas Steve Hicks School of Social Work, Austin, TX, USA.'}, {'ForeName': 'Goodgame', 'Initials': 'G', 'LastName': 'Boone', 'Affiliation': '12330University of Texas Dell Medical School, Austin, TX, USA.'}]",The American journal of hospice & palliative care,['10.1177/1049909120921834']
2148,32896184,"Remdesivir, a remedy or a ripple in severe COVID-19?","INTRODUCTION


In clinical trial for the Ebola virus, the broad-spectrum anti-viral agent remdesivir was shown to have a good safety profile. Remdesivir is now being tested in severe COVID-19.
AREAS COVERED


The Gilead Sciences SIMPLE trial suggests that the short-term use of remdesivir probably does not increase mortality dramatically or have serious short-term toxicity when used to treat severe COVID-19. The Adaptive COVID-19 treatment trials (ACTT1) trial showed that remdesivir may shorten recovery and decrease mortality in severe COVID-19 without increasing adverse effects.
EXPERT OPINION


It seems to me that we have learnt very little from the SIMPLE trial, and this would be predicted from a trial that has no control or placebo group. The results of ACTT1 were reported early after an interim analysis showed that a higher than expected number of recoveries had occurred. There was an indication that remdesivir may be reducing mortality, but this was not statistical significance. The trial is continuing, and the final data is eagerly awaited to determine whether remdesivir is a game changing remedy or a ripple in the ongoing search for a medicine for the treatment of COVID-19.",2020,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.",[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.155191,"There was an indication that remdesivir may be reducing mortality, but this was not statistical significance.","[{'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Doggrell', 'Affiliation': ''}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1821645']
2149,32887287,Effects of Thoracic Mobilization and Extension Exercise on Thoracic Alignment and Shoulder Function in Patients with Subacromial Impingement Syndrome: A Randomized Controlled Pilot Study.,"Introduction:  Thoracic kyphosis commonly occurs in subacromial impingement syndrome. This pilot study investigated the effect of thoracic joint mobilization and extension exercise on improving thoracic alignment and shoulder function.  Methods:  In total, 30 patients with subacromial impingement syndrome were recruited and randomly assigned to three groups, the joint mobilization group ( n  = 10), exercise group ( n  = 10), and combination group ( n  = 10). After four weeks of treatment, the measured outcomes included thoracic kyphosis using a manual inclinometer; pectoralis major (PM) and upper trapezius (UT) muscle tone and stiffness using the MyotonPRO ® ; affected side passive range of motion (ROM) using the goniometer (flexion, abduction, medial rotation, and lateral rotation); and shoulder pain and disability index (SPADI).  Results:  All three groups had significant improvements in all variables ( p  < 0.05). Thoracic kyphosis; UT muscle tone; and flexion, medial rotation, and lateral rotation ROM and SPADI were all significantly improved in the combination group compared to the mobilization and exercise groups ( p  < 0.05).  Conclusions:  The combination therapy of thoracic mobilization and extension exercise can be regarded as a promising method to improve thoracic alignment and shoulder function in patients with subacromial impingement syndrome.",2020,All three groups had significant improvements in all variables ( p  < 0.05).,"['30 patients with subacromial impingement syndrome', 'Patients with Subacromial Impingement Syndrome', 'subacromial impingement syndrome', 'patients with subacromial impingement syndrome']","['thoracic joint mobilization and extension exercise', 'joint mobilization group', 'Thoracic Mobilization and Extension Exercise', 'thoracic mobilization and extension exercise', 'exercise group']","['thoracic kyphosis using a manual inclinometer; pectoralis major (PM) and upper trapezius (UT) muscle tone and stiffness using the MyotonPRO ® ; affected side passive range of motion (ROM) using the goniometer (flexion, abduction, medial rotation, and lateral rotation); and shoulder pain and disability index (SPADI', 'flexion, medial rotation, and lateral rotation ROM and SPADI', 'Thoracic Alignment and Shoulder Function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",30.0,0.0817838,All three groups had significant improvements in all variables ( p  < 0.05).,"[{'ForeName': 'Shin Jun', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Gangdong University, 278, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do 27600, Korea.'}, {'ForeName': 'Seok Hyeon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, General Graduate School, Yongin University, 134, Yongindaehak-ro, Cheoin-gu, Yongin-si, Gyeonggi-do 17092, Korea.'}, {'ForeName': 'Soon Hee', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Yongin University, 134, Yongindaehak-ro, Cheoin-gu, Yongin-si, Gyeonggi-do 17092, Korea.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8030316']
2150,32891079,The effects of lower extremity cross-training on gait and balance in stroke patients: a double-blinded randomised controlled trial.,"BACKGROUND


Cross-training is an indirect intervention to promote muscle activity on the affected side by applying resistance exercise to stronger parts of the body. Indirect interventions are useful for treating patients who have difficulty with direct interventions. Previous studies have focused on measuring increased muscle strength and muscle activity in healthy individuals.
AIM


This study aimed to investigate the effects of cross-training on gait and balance in hemiplegic patients when applied to the affected and unaffected lower extremities.
DESIGN


Double-blinded randomised controlled trial.
SETTING


In-patients attending the rehabilitation treatment room of a single centre.
POPULATION


Fifty-two stroke patients were randomly allocated to a control group (n=19), affected side cross-training group (n=15), and unaffected side cross-training group (n=18).
METHODS


Patients were administered general neurological physiotherapy for 30 mins, twice daily, 5 days/week for 4 weeks. The two intervention groups underwent 30 mins of cross-training instead of general neurological physiotherapy once daily, 3 days/week for 4 weeks (post-intervention). For data analysis, one-way ANOVA for between-group comparisons and paired t-tests were performed for within-group comparisons between pre- and post-intervention groups (significance level of .05).
RESULTS


In the Timed Up and Go test (TUG), comparing pre- and post-intervention, the control group showed no significant change (p>.05), while the affected side and unaffected side cross-training groups showed significant improvements in function (p<.05). In the 10 Meter Walk Test (10MWT), the control group showed no significant change (p>.05), while the affected side and unaffected side cross-training groups showed significant increases in speed (p<.05). In balance testing, the limits of stability showed a significantly increase in all three groups (p<.05). There were no pre- or post-intervention differences in gait or balance between the groups (p>.05).
CONCLUSIONS


Gait and balance improved in hemiplegic stroke patients who participated in cross-training, regardless of the intervention applied to the affected or unaffected side.
CLINICAL REHABILITATION IMPACT


In clinical settings, for patients who experience difficulties with direct interventions on the affected side, we propose indirect interventions to improve gait and balance.",2020,"There were no pre- or post-intervention differences in gait or balance between the groups (p>.05).
","['Patients were administered', 'patients who have difficulty with direct interventions', 'hemiplegic patients', 'Fifty-two stroke patients', 'stroke patients', 'In-patients attending the rehabilitation treatment room of a single centre', 'hemiplegic stroke patients', 'healthy individuals']","['cross-training', 'cross-training instead of general neurological physiotherapy', 'lower extremity cross-training', 'Indirect interventions', 'general neurological physiotherapy', 'side cross-training group (n=15), and unaffected side cross-training group']","['gait and balance', 'muscle strength and muscle activity', 'limits of stability', 'gait or balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4042764', 'cui_str': 'Neurophysiotherapy'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",52.0,0.0372953,"There were no pre- or post-intervention differences in gait or balance between the groups (p>.05).
","[{'ForeName': 'Chanhyun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Team of Rehabilitation, Keunsol Medical Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Hohee', 'Initials': 'H', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health Science, Catholic University of Pusan, Busan, Republic of Korea - sonhh@cup.ac.kr.'}, {'ForeName': 'Bokgi', 'Initials': 'B', 'LastName': 'Yeo', 'Affiliation': 'Department of Physical Therapy, Team of Rehabilitation, Keunsol Medical Hospital, Busan, Republic of Korea.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06183-3']
2151,32891115,Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial.,"BACKGROUND


The cross-sectional area of the subclavian vein (csSCV) is a crucial factor in the successful catheterization of the subclavian vein. This randomized controlled study investigated the effects of the csSCV on landmark-based subclavian vein catheterization.
METHODS


This study was performed using a two-stage protocol. During stage I, the csSCV was measured in 17 patients placed in the supine, 20° ipsilateral tilt, and 20° contralateral tilt positions in a random order. During stage II, landmark-based subclavian vein catheterization was randomly performed in patients placed in either the supine (group S, n = 107) or the ipsilateral tilt (group I, n = 109) position. The primary outcome measure was the csSCV in stage I and the primary venipuncture success rate in stage II. Secondary outcome measures were the time to successful venipuncture, the total catheterization time, the first-pass success rate, and the incidence of mechanical complications during catheterization.
RESULTS


The csSCV was significantly larger in the ipsilateral tilt than in either the supine or contralateral tilt position (1.01 ± 0.35 vs. 0.84 ± 0.32 and 0.51 ± 0.26 cm 2 , P = .006 and < .001, respectively). The primary venipuncture success rate did not differ significantly between the group S and I (57.0 vs. 64.2%, P = .344). There were also no significant differences in the secondary outcome measures of the two groups.
CONCLUSIONS


The csSCV was significantly larger in patients placed in the ipsilateral tilt than in the supine position, but the difference did not result in better clinical performance of landmark-based subclavian vein catheterization.
TRIAL REGISTRATION


NCT03296735 for stage I ( ClinicalTrials.gov , September 28, 2017) and NCT03303274 for stage II ( ClinicalTrials.gov , October 6, 2017).",2020,"The csSCV was significantly larger in the ipsilateral tilt than in either the supine or contralateral tilt position (1.01 ± 0.35 vs. 0.84 ± 0.32 and 0.51 ± 0.26 cm 2 , P = .006 and < .001, respectively).",[],"['csSCV', 'subclavian vein (csSCV', 'subclavian vein catheterization', 'ipsilateral tilt', 'landmark-based subclavian vein catheterization', 'ipsilateral tilt position']","['clinical performance of landmark-based subclavian vein catheterization', 'time to successful venipuncture, the total catheterization time, the first-pass success rate, and the incidence of mechanical complications during catheterization', 'csSCV in stage', 'primary venipuncture success rate']",[],"[{'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C1319106', 'cui_str': 'Catheterization of subclavian vein'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1319106', 'cui_str': 'Catheterization of subclavian vein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.121587,"The csSCV was significantly larger in the ipsilateral tilt than in either the supine or contralateral tilt position (1.01 ± 0.35 vs. 0.84 ± 0.32 and 0.51 ± 0.26 cm 2 , P = .006 and < .001, respectively).","[{'ForeName': 'Hyun-Kyu', 'Initials': 'HK', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Hyung-Chul', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Pyoyoon', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jung-Man', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Youn Joung', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehakro, Jongno-gu, Seoul, 03080, South Korea. mingming7@gmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01144-1']
2152,32891126,A virtual clinic for the management of diabetes-type 1: study protocol for a randomised wait-list controlled clinical trial.,"BACKGROUND


Diabetes is a serious chronic disease. Medical treatment and good psychosocial support are needed to cope with acute and long-term effects of diabetes. Self-management is a large part of diabetes management, with healthcare providers playing a supportive role. Young adults with type 1 diabetes are of special interest as they tend to have higher mean glycosylated haemoglobin values than other patients with type 1 diabetes, and they often miss visits in traditional diabetes care. A well-designed virtual solution may improve a range of measures (e.g. glycaemic control and perceived health) and reduce hospitalisations.
METHOD


This randomised controlled trial with a control group using a wait list design will recruit 100 young adults from a hospital in Sweden. All participants will receive usual diabetes care besides the virtual clinic. The primary objective is to evaluate the effect of a virtual diabetes clinic on glycaemic control, treatment satisfaction and quality of life in young adults (aged 18-25 years) with type-1 diabetes. The secondary objective is to determine the effects of virtual care on the patient experience.
DISCUSSION


Virtual tools are becoming increasingly common in healthcare; however, it remains unclear if these tools improve diabetes self-management. The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
TRIAL REGISTRATION


Current controlled trials: ISRCTN, number: 73435627, registered 23 October 2019. https://doi.org/10.1186/ISRCTN73435627.",2020,"The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
","['100 young adults from a hospital in Sweden', 'Young adults with type 1 diabetes', 'young adults (aged 18-25\u2009years) with type-1 diabetes', 'number: 73435627, registered 23 October 2019']",['virtual diabetes clinic'],"['glycaemic control, treatment satisfaction and quality of life']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",100.0,0.0803413,"The results of this study will build understanding of how healthcare providers can use a virtual clinic to improve diabetes self-management.
","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Nerpin', 'Affiliation': 'Department of Medical Sciences, Respiratory Medicine, Allergy and Sleep, Uppsala University, Uppsala, Sweden. ene@du.se.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Toft', 'Affiliation': 'Department of Medicine, Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Fischier', 'Affiliation': 'Diabetes Unit, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lindholm-Olinder', 'Affiliation': 'Department of Medical Sciences, Clinical Diabetology and Metabolism, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Janeth', 'Initials': 'J', 'LastName': 'Leksell', 'Affiliation': 'School of Education, Health and Social Studies, Dalarna University, SE-791 88, Falun, Sweden.'}]",BMC endocrine disorders,['10.1186/s12902-020-00615-3']
2153,32891136,Efficacy of different dose of dexmedetomidine combined with remifentanil in colonoscopy: a randomized controlled trial.,"BACKGROUND


Dexmedetomidine has advantages during colonoscopy as it allows the patient to cooperate during the procedure. Few studies examined the dexmedetomidine-remifentanil combination. This study was to evaluate the effects of different doses of the dexmedetomidine-remifentanil combination in colonoscopy.
METHODS


This was a prospective trial carried out at the Fourth Hospital of Hebei Medical University between 02/2018 and 10/2018. The patients were randomized: group I (dexmedetomidine 0.2 μg·kg - 1 ), group II (dexmedetomidine 0.3 μg·kg - 1 ), and group III (dexmedetomidine 0.4 μg·kg - 1 ), all combined with remifentanil. The primary outcomes were the patient's body movements during the procedure and adverse events.
RESULTS


Compared with at admission (T 0 ), the SBP, HR, and RR at immediately after giving DEX (T 1 ), at the beginning of the examination (T 2 ), 5 min after the beginning of the examination (T 3 ), 10 min after the beginning of the examination (T 4 ), and at the end of the examination (T 5 ) in the three groups were all reduced (all P < 0.05), but all were within the clinically normal range. SpO 2  remained > 98% in all patients during the examination. Compared with T 0 , the BIS values of the three groups were decreased at T 1  and T 2  (all P < 0.05). There were no significant differences in BIS among the three groups (all P > 0.05). The minimum BIS value in group III was lower than in groups I and II (P < 0.05). The degree of satisfaction with the anesthesia effect was higher in groups II and III that in group I (P < 0.05). No hypotension occurred, seven patients had bradycardia, and four patients had nausea/vomiting.
CONCLUSIONS


Dexmedetomidine 0.3 μg·kg - 1  combined with remifentanil was effective for colonoscopy and had few adverse reactions. Chinese Clinical Trial Registry: ChiCTR2000029105 , Registered 13 January 2020 - Retrospectively registered.",2020,The degree of satisfaction with the anesthesia effect was higher in groups II and III that in group I (P < 0.05).,"['Registered 13 January 2020 - Retrospectively registered', 'colonoscopy', 'Fourth Hospital of Hebei Medical University between 02/2018 and 10/2018']","['dexmedetomidine 0.2\u2009μg·kg -\u20091 ), group II (dexmedetomidine 0.3\u2009μg·kg -\u20091 ), and group III', 'dexmedetomidine 0.4\u2009μg·kg -\u20091 ), all combined with remifentanil', 'Dexmedetomidine', 'remifentanil', 'dexmedetomidine-remifentanil', 'dexmedetomidine combined with remifentanil']","['BIS values', 'hypotension', 'degree of satisfaction with the anesthesia effect', 'BIS', 'minimum BIS value', 'SBP, HR, and RR', 'nausea/vomiting', ""patient's body movements during the procedure and adverse events""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0661239,The degree of satisfaction with the anesthesia effect was higher in groups II and III that in group I (P < 0.05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Tong', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Xing', 'Affiliation': 'Department of Anesthesiology, Fourth Hospital of Hebei Medical University, No. 12, Jiankang Road, Shijiazhuang, 050000, Hebei, China. 281575038@qq.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01141-4']
2154,32891170,"(1,3)-β-D-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial.","BACKGROUND


(1,3)-β-D-Glucan has been widely used in clinical practice for the diagnosis of invasive Candida infections. However, such serum biomarker showed potential to guide antimicrobial therapy in order to reduce the duration of empirical antifungal treatment in critically ill septic patients with suspected invasive candidiasis.
METHODS


This was a single-centre, randomized, open-label clinical trial in which critically ill patients were enrolled during the admission to the intensive care unit (ICU). All septic patients who presented invasive Candida infection risk factors and for whom an empirical antifungal therapy was commenced were randomly assigned (1:1) in those stopping antifungal therapy if (1,3)-β-D-glucan was negative ((1,3)-β-D-glucan group) or those continuing the antifungal therapy based on clinical rules (control group). Serum 1,3-β-D-glucan was measured at the enrolment and every 48/72 h over 14 days afterwards. The primary endpoint was the duration of antifungal treatment in the first 30 days after enrolment.
RESULTS


We randomized 108 patients into the (1,3)-β-D-glucan (n = 53) and control (n = 55) groups. Median [IQR] duration of antifungal treatment was 2 days [1-3] in the (1,3)-β-D-glucan group vs. 10 days [6-13] in the control group (between-group absolute difference in means, 6.29 days [95% CI 3.94-8.65], p < 0.001). Thirty-day mortality was similar (28.3% [(1,3)-β-D-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-D-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).
CONCLUSIONS


In critically ill septic patients admitted to the ICU at risk of invasive candidiasis, a (1,3)-β-D-glucan-guided strategy could reduce the duration of empirical antifungal therapy. However, the safety of this algorithm needs to be confirmed in future, multicentre clinical trial with a larger population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03117439 , retrospectively registered on 18 April 2017.",2020,"Thirty-day mortality was similar (28.3% [(1,3)-β-D-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-D-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).
","['18 April 2017', 'critically ill septic patients admitted to the ICU at risk of invasive candidiasis', '108 patients into the (1,3)-β-D-glucan (n\u2009=\u200953) and control (n\u2009=\u200955) groups', 'critically ill septic patients with suspected invasive candidiasis', 'suspected invasive candidiasis', 'critically ill patients were enrolled during the admission to the intensive care unit (ICU', 'All septic patients who presented invasive Candida infection risk factors and for whom an empirical antifungal therapy was commenced were randomly assigned (1:1) in those']","['1,3)-β-D-Glucan-based empirical antifungal interruption', 'stopping antifungal therapy if (1,3)-β-D-glucan was negative ((1,3)-β-D-glucan group) or those continuing the antifungal therapy based on clinical rules (control group']","['length of mechanical ventilation', 'Serum 1,3-β-D-glucan', 'Thirty-day mortality', 'duration of antifungal treatment', 'overall rate of documented candidiasis', 'Median [IQR] duration of antifungal treatment', 'ICU stay']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0153252', 'cui_str': 'Invasive candidiasis'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003308', 'cui_str': 'Antifungal-containing product'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0219900', 'cui_str': 'polyglucosan'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2363963', 'cui_str': 'Antifungal treatment'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0006840', 'cui_str': 'Candidiasis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",108.0,0.153783,"Thirty-day mortality was similar (28.3% [(1,3)-β-D-glucan group] vs. 27.3% [control group], p = 0.92) as well as the overall rate of documented candidiasis (11.3% [(1,3)-β-D-glucan group] vs. 12.7% [control group], p = 0.94), the length of mechanical ventilation (p = 0.97) and ICU stay (p = 0.23).
","[{'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'De Pascale', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy. gennaro.depascalemd@gmail.com.""}, {'ForeName': 'Brunella', 'Initials': 'B', 'LastName': 'Posteraro', 'Affiliation': 'Dipartimento di Scienze Gastroenterologiche, Endocrino-Metaboliche e Nefro-Urologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': ""D'Arrigo"", 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Spinazzola', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Gaspari', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bello', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Luca Maria', 'Initials': 'LM', 'LastName': 'Montini', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Salvatore Lucio', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Domenico Luca', 'Initials': 'DL', 'LastName': 'Grieco', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Gravio', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'De Angelis', 'Affiliation': 'Università Cattolica del Sacro Cuore, Istituto di Microbiologia, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Torelli', 'Affiliation': 'Dipartimento di Scienze di Laboratorio e Infettivologiche, UOC di Microbiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'De Carolis', 'Affiliation': 'Dipartimento di Scienze di Laboratorio e Infettivologiche, UOC di Microbiologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tumbarello', 'Affiliation': 'Dipartimento di Scienze di Laboratorio e Infettivologiche , UOC di Malattie Infettive, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Sanguinetti', 'Affiliation': 'Università Cattolica del Sacro Cuore, Istituto di Microbiologia, Largo F. Vito 1, 00168, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Antonelli', 'Affiliation': ""Dipartimento di Scienza dell'Emergenza, Anestesiologiche e della Rianimazione - UOC di Anestesia, Rianimazione, Terapia Intensiva e Tossicologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Largo A. Gemelli 8, 00168, Rome, Italy.""}]","Critical care (London, England)",['10.1186/s13054-020-03265-y']
2155,32891190,Correction to Lancet Oncol 2020; published online Aug 24. https://doi.org/10.1016/S1470-2045(20)30442-3.,,2020,,[],[],[],[],[],[],,0.0224456,,[],The Lancet. Oncology,['10.1016/S1470-2045(20)30531-3']
2156,32891191,"Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial.","BACKGROUND


Group B streptococcus (GBS) is a major cause of invasive disease in young infants. Infants born to women with sufficient pre-existing anti-GBS capsular IgG antibodies are at reduced risk of GBS disease, making maternal immunisation a potential strategy for prevention. We aimed to assess the safety and immunogenicity of a novel hexavalent (serotypes Ia, Ib, II, III, IV, and V) GBS conjugate vaccine (GBS6).
METHODS


This phase 1/2, placebo-controlled, observer-blinded, dose-escalation trial, was done at four clinical research centres in the USA (Kentucky, Georgia, and two sites in Utah). Healthy, non-pregnant adults aged 18-49 years were randomly assigned using an interactive, web-based response technology system. Within each dose group (low, medium, or high), participants in sentinel cohorts were randomly assigned 2:2:1 and expanded cohort participants were randomly assigned 4:4:1 to receive GBS6 with aluminium phosphate (AlPO 4 ), GBS6 without AlPO 4 , or placebo (saline control). One 0·5 mL dose of either saline placebo or 5 μg capsular polysaccharide per serotype in the low-dose group, 10 μg capsular polysaccharide per serotype in the medium-dose group, or 20 μg capsular polysaccharide per serotype in the high-dose group was administered by intramuscular injection into the deltoid muscle on day 1. The primary outcome was safety up to 6 months after vaccination, including the proportion of sentinel cohort participants with clinical laboratory abnormalities at 1 week, the proportion of all participants reporting solicited local reactions, systemic events, or use of antipyretic or pain medication within 14 days, adverse events up to 1 month, and medically attended or serious adverse events up to 6 months. The secondary outcome was GBS immunogenicity (serotype-specific IgG geometric mean concentrations at 1 month). This study is registered with ClinicalTrials.gov, NCT03170609.
FINDINGS


Between June 5, 2017, and June 25, 2018, 365 participants were randomly assigned and 364 (52 in each dose group) were vaccinated and included in the safety analysis. Unsolicited adverse events were reported by 15 (29%) participants in the 5 μg with AlPO 4  group, 13 (25%) in the 5 μg without AlPO 4  group, 22 (42%) in the 10 μg with AlPO 4  group, 12 (23%) in the 10 μg without AlPO 4  group, 25 (48%) in the 20 μg with AlPO 4  group, 21 (40%) in the 20 μg without AlPO 4  group, and 20 (38%) in the placebo group. The most common unsolicited adverse events were in the system organ class of infections and infestations in any dose or formulation of GBS6 (ranging from six [12%] in the 10 μg without AlPO 4  group to 15 [29%] in the 20 μg with AlPO 4  group and placebo group). Three participants reported at least one serious adverse event during the study, one each in the 5 μg GBS6 with AlPO 4  group (diabetic ketoacidosis, two events; resolved), 10 μg GBS6 with AlPO 4  group (died by suicide), and 20 μg GBS6 with AlPO 4  group (metrorrhagia; resolved). None of these serious adverse events were considered related to the vaccine. 11 of the 365 participants were excluded from the evaluable immunogenicity population, including one participant who did not receive the vaccine, and ten who at 1 month after vaccination were withdrawn for various reasons. GBS serotype-specific IgG geometric mean concentrations increased by 1 week after vaccination for all GBS6 groups, peaked at 2 weeks, stabilised by 1 month, and declined gradually but remained higher than placebo at 6 months.
INTERPRETATION


GBS6 was well tolerated in healthy adults and elicited robust immune responses for all dose levels and formulations that persisted 6 months after vaccination. This study supports further evaluation of GBS6 in pregnant women.
FUNDING


Pfizer.",2020,"GBS serotype-specific IgG geometric mean concentrations increased by 1 week after vaccination for all GBS6 groups, peaked at 2 weeks, stabilised by 1 month, and declined gradually but remained higher than placebo at 6 months.
","['Between June 5, 2017, and June 25, 2018, 365 participants', 'Healthy, non-pregnant adults aged 18-49 years', 'pregnant women', 'young infants', '11 of the 365 participants were excluded from the evaluable immunogenicity population, including one participant who did not receive the vaccine, and ten who at 1 month after vaccination were withdrawn for various reasons', 'healthy, non-pregnant adults', 'Infants born to women with sufficient pre-existing anti-GBS capsular IgG antibodies', 'healthy adults']","['novel hexavalent group B streptococcus conjugate vaccine', 'saline placebo', 'GBS6 with aluminium phosphate (AlPO 4 ), GBS6 without AlPO 4 , or placebo (saline control', 'placebo', 'novel hexavalent (serotypes Ia, Ib, II, III, IV, and V) GBS conjugate vaccine (GBS6']","['Safety and immunogenicity', 'GBS serotype-specific IgG geometric mean concentrations', 'Unsolicited adverse events', 'proportion of sentinel cohort participants with clinical laboratory abnormalities', 'serious adverse event', 'GBS immunogenicity (serotype-specific IgG geometric mean concentrations', 'safety and immunogenicity', 'solicited local reactions, systemic events, or use of antipyretic or pain medication within 14 days, adverse events up to 1 month, and medically attended or serious adverse events']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0051519', 'cui_str': 'aluminum phosphate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444974', 'cui_str': 'Ia'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",365.0,0.429354,"GBS serotype-specific IgG geometric mean concentrations increased by 1 week after vaccination for all GBS6 groups, peaked at 2 weeks, stabilised by 1 month, and declined gradually but remained higher than placebo at 6 months.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Absalon', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA. Electronic address: judith.absalon@pfizer.com.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Segall', 'Affiliation': 'Clinical Research Atlanta, Stockbridge, GA, USA.'}, {'ForeName': 'Stan L', 'Initials': 'SL', 'LastName': 'Block', 'Affiliation': 'Kentucky Pediatric/Adult Research, Bardstown, KY, USA.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Center', 'Affiliation': 'Vaccine Research and Development, Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Ingrid L', 'Initials': 'IL', 'LastName': 'Scully', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Giardina', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'Foothill Family Clinic, Salt Lake City, UT, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Watson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Vaccine Research and Development, Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Munson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Danka', 'Initials': 'D', 'LastName': 'Pavliakova', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Vaccine Research and Development, Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Annaliesa S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Pearl River, NY, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30478-3']
2157,32891212,"Once-daily, subcutaneous vosoritide therapy in children with achondroplasia: a randomised, double-blind, phase 3, placebo-controlled, multicentre trial.","BACKGROUND


There are no effective therapies for achondroplasia. An open-label study suggested that vosoritide administration might increase growth velocity in children with achondroplasia. This phase 3 trial was designed to further assess these preliminary findings.
METHODS


This randomised, double-blind, phase 3, placebo-controlled, multicentre trial compared once-daily subcutaneous administration of vosoritide with placebo in children with achondroplasia. The trial was done in hospitals at 24 sites in seven countries (Australia, Germany, Japan, Spain, Turkey, the USA, and the UK). Eligible patients had a clinical diagnosis of achondroplasia, were ambulatory, had participated for 6 months in a baseline growth study and were aged 5 to less than 18 years at enrolment. Randomisation was done by means of a voice or web-response system, stratified according to sex and Tanner stage. Participants, investigators, and trial sponsor were masked to group assignment. Participants received either vosoritide 15·0 μg/kg or placebo, as allocated, for the duration of the 52-week treatment period administered by daily subcutaneous injections in their homes by trained caregivers. The primary endpoint was change from baseline in mean annualised growth velocity at 52 weeks in treated patients as compared with controls. All randomly assigned patients were included in the efficacy analyses (n=121). All patients who received one dose of vosoritide or placebo (n=121) were included in the safety analyses. The trial is complete and is registered, with EudraCT, number, 2015-003836-11.
FINDINGS


All participants were recruited from Dec 12, 2016, to Nov 7, 2018, with 60 assigned to receive vosoritide and 61 to receive placebo. Of 124 patients screened for eligibility, 121 patients were randomly assigned, and 119 patients completed the 52-week trial. The adjusted mean difference in annualised growth velocity between patients in the vosoritide group and placebo group was 1·57 cm/year in favour of vosoritide (95% CI [1·22-1·93]; two-sided p<0·0001). A total of 119 patients had at least one adverse event; vosoritide group, 59 (98%), and placebo group, 60 (98%). None of the serious adverse events were considered to be treatment related and no deaths occurred.
INTERPRETATION


Vosoritide is an effective treatment to increase growth in children with achondroplasia. It is not known whether final adult height will be increased, or what the harms of long-term therapy might be.
FUNDING


BioMarin Pharmaceutical.",2020,"None of the serious adverse events were considered to be treatment related and no deaths occurred.
","['All participants were recruited from Dec 12, 2016, to Nov 7, 2018, with 60 assigned to receive vosoritide and 61 to receive', 'children with achondroplasia', 'hospitals at 24 sites in seven countries (Australia, Germany, Japan, Spain, Turkey, the USA, and the UK', '119 patients had at least one adverse event; vosoritide group, 59 (98%), and', 'Eligible patients had a clinical diagnosis of achondroplasia, were ambulatory, had participated for 6 months in a baseline growth study and were aged 5 to less than 18 years at enrolment', '124 patients screened for eligibility, 121 patients were randomly assigned, and 119 patients completed the 52-week trial']","['vosoritide with placebo', 'placebo', 'vosoritide or placebo', 'subcutaneous vosoritide therapy', 'vosoritide', 'vosoritide 15·0 μg/kg or placebo']","['annualised growth velocity', 'mean annualised growth velocity', 'growth velocity']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4519745', 'cui_str': 'vosoritide'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001080', 'cui_str': 'Achondroplasia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4519745', 'cui_str': 'vosoritide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",121.0,0.793501,"None of the serious adverse events were considered to be treatment related and no deaths occurred.
","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Savarirayan', 'Affiliation': ""Murdoch Children's Research Institute, Royal Children's Hospital, and University of Melbourne, Parkville, VIC, Australia. Electronic address: ravi.savarirayan@vcgs.org.au.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Tofts', 'Affiliation': ""Kids Rehab, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Irving', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, Evelina Children's Hospital, London, UK.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wilcox', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Bacino', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoover-Fong', 'Affiliation': 'McKusick-Nathans Department of Genetic Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Rosendo', 'Initials': 'R', 'LastName': 'Ullot Font', 'Affiliation': 'Hospital Sant Joan de Déu, Barcelona, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harmatz', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, Oakland, CA, USA.""}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rutsch', 'Affiliation': ""Department of General Pediatrics, Muenster University Children's Hospital, Muenster, Germany.""}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Bober', 'Affiliation': 'Nemours-Alfred I. du Pont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Lynda E', 'Initials': 'LE', 'LastName': 'Polgreen', 'Affiliation': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Ginebreda', 'Affiliation': 'Hospital Universitario Quirón Dexeus, Barcelona, Spain.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Mohnike', 'Affiliation': 'Otto-von-Guericke-Universität, Magdeburg, Germany.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Charrow', 'Affiliation': ""Ann and Robert H Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hoernschmeyer', 'Affiliation': 'University of Missouri-Columbia, Columbia, MO, USA.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ozono', 'Affiliation': 'Osaka University Hospital, Osaka, Japan.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Alanay', 'Affiliation': 'Acibadem Mehmet Ali Aydiniar University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Arundel', 'Affiliation': ""Sheffield Children's NHS Foundation Trust, Sheffield Children's Hospital, Sheffield, UK.""}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kagami', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Natsuo', 'Initials': 'N', 'LastName': 'Yasui', 'Affiliation': 'Tokushima University Hospital, Tokushima, Japan.'}, {'ForeName': 'Klane K', 'Initials': 'KK', 'LastName': 'White', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Saal', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Leiva-Gea', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Luna-González', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Málaga, Spain.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mochizuki', 'Affiliation': ""Saitama Children's Hospital, Saitama, Japan.""}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Basel', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Dania M', 'Initials': 'DM', 'LastName': 'Porco', 'Affiliation': 'BioMarin Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Kala', 'Initials': 'K', 'LastName': 'Jayaram', 'Affiliation': 'BioMarin Pharmaceutical, Novato, CA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Fisheleva', 'Affiliation': 'BioMarin (UK), London, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Huntsman-Labed', 'Affiliation': 'BioMarin (UK), London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Day', 'Affiliation': 'BioMarin (UK), London, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31541-5']
2158,32891272,The effects of lavender aromatherapy on stress and pain perception in children during dental treatment: A randomized clinical trial.,"BACKGROUND AND PURPOSE


Reducing dental anxiety is a major aspect of childmanagement in dental visits. This crossover randomized clinical trial was designed to determine the effect of lavender aromatherapy on anxiety level during dental treatment and pain perception during dental injection in children.
MATERIALS AND METHODS


Twenty-four children aged 7-9 years received restorative treatment with lavender aromatherapy in the intervention session and without aroma in the control session. Salivary cortisol and pulse rate were measured to evaluate child's anxiety level and the Face Rating Scale (FRS) was used for assessing the pain perception during injection in both visits.
RESULTS


The treatment effect on salivary cortisol, pulse rate, and FRS score was -8.01 ± 0.92 nmol/l, -11.17 ± 1.28 (in minutes), and -2.00 ± 0.41 respectively, which was statistically significant (P < 0.001).
CONCLUSION


Lavender aromatherapy can decrease dental anxiety and experienced pain in dental setting.",2020,"The treatment effect on salivary cortisol, pulse rate, and FRS score was -8.01 ± 0.92 nmol/l, -11.17 ± 1.28 (in minutes), and -2.00 ± 0.41 respectively, which was statistically significant (P < 0.001).
","['Twenty-four children aged 7-9 years received', 'dental treatment and pain perception during dental injection in children', 'children during dental treatment']","['restorative treatment with lavender aromatherapy in the intervention session and without aroma in the control session', 'lavender aromatherapy', 'Lavender aromatherapy']","['stress and pain perception', 'salivary cortisol, pulse rate, and FRS score', 'dental anxiety and experienced pain', 'anxiety level', ""child's anxiety level and the Face Rating Scale (FRS"", 'Salivary cortisol and pulse rate', 'pain perception']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2987717', 'cui_str': 'Scents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",24.0,0.0851904,"The treatment effect on salivary cortisol, pulse rate, and FRS score was -8.01 ± 0.92 nmol/l, -11.17 ± 1.28 (in minutes), and -2.00 ± 0.41 respectively, which was statistically significant (P < 0.001).
","[{'ForeName': 'Faezeh', 'Initials': 'F', 'LastName': 'Ghaderi', 'Affiliation': 'Pediatric Dentistry Department, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Solhjou', 'Affiliation': 'Pediatric Dentistry Department, Shiraz University of Medical Sciences, Shiraz, Fars, Iran. Electronic address: nsolhjou@yums.ac.ir.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101182']
2159,32891275,Preferred exercise and mental health of the patients with fibromyalgia syndrome.,"BACKGROUND AND PURPOSE


Preferred exercise may be beneficial for the mental health of patients with fibromyalgia syndrome (FMS).This study aimed to investigate the effects of preferred exercise on the quality of life (Qol), depression, and mood states of the patients with FMS.
MATERIALS AND METHODS


This study was a nonrandomized controlled trial. The patients with FMS were divided into an experimental group (EG; n = 22) and a control group (CG; n = 14). The patients in the EG performed their preferred exercise (resistance, walking, or stretching) for 12 weeks. CG went to a waiting list. Fibromyalgia Impact Questionnaire, Beck Depression Inventory, and Brunel Mood Scale were used to evaluate the outcomes.
RESULTS


The EG exhibited a decrease in the total impact of FMS on the Qol, depression, tension, and mental confusion (p < 0.01).
CONCLUSION


Preferred exercises reduced the impact of FMS on the Qol, depression, and mental confusion of patients with FMS.",2020,"The EG exhibited a decrease in the total impact of FMS on the Qol, depression, tension, and mental confusion (p < 0.01).
","['patients with FMS', 'patients with fibromyalgia syndrome']","['preferred exercise (resistance, walking, or stretching']","['Qol, depression, and mental confusion', 'quality of life (Qol), depression, and mood states', 'Fibromyalgia Impact Questionnaire, Beck Depression Inventory, and Brunel Mood Scale', 'total impact of FMS on the Qol, depression, tension, and mental confusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]",22.0,0.0188064,"The EG exhibited a decrease in the total impact of FMS on the Qol, depression, tension, and mental confusion (p < 0.01).
","[{'ForeName': 'Alexandro', 'Initials': 'A', 'LastName': 'Andrade', 'Affiliation': 'Department of Human Movement Science, Santa Catarina State University - UDESC, Florianópolis, Santa Catarina, Brazil. Electronic address: alexandro.andrade.phd@gmail.com.'}, {'ForeName': 'Ricardo de Azevedo Klumb', 'Initials': 'RAK', 'LastName': 'Steffens', 'Affiliation': 'Regional University of Blumenau - FURB, Blumenau, Santa Catarina, Brazil.'}, {'ForeName': 'Guilherme Torres', 'Initials': 'GT', 'LastName': 'Vilarino', 'Affiliation': 'Department of Human Movement Science, Santa Catarina State University - UDESC, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'Department of Physical Education, FAEFID, Juiz de Fora Federal University - UFJF, Juiz de Fora, Minas Gerais, Brazil.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Benetti', 'Affiliation': 'Department of Human Movement Science, Santa Catarina State University - UDESC, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Danilo Reis', 'Initials': 'DR', 'LastName': 'Coimbra', 'Affiliation': 'Departament of Physical Education, ICV, Juiz de Fora Federal University - UFJF, Governador Valadares, Minas Gerais, Brazil.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101195']
2160,32891278,The effect of aromatherapy with peppermint essential oil on nausea and vomiting after cardiac surgery: A randomized clinical trial.,"Background Postoperative nausea and vomiting are common in patients who underwent cardiac surgery. This study aimed to examine the effect of peppermint essential oil inhalation on the postoperative nausea and vomiting after cardiac surgery. Methods In this clinical trial study, 60 cardiac surgery patients were divided into control and intervention groups. The intervention group underwent nebulizer aromatherapy with peppermint essential oil before the endotracheal tube was removed after surgery. Patients' nausea and vomiting were then assessed through a checklist. The independent-samples t-test, chi-square, and Generalized estimating equation were used for data analysis. Results Totally 85.7% of the patients undergone coronary artery bypass graft surgery. The two groups did not significantly differ in terms of their baseline demographic and clinical variables (P > 0.05). Significant differences were found between the intervention and control groups in terms of the frequency of nausea (0.63 ± 0.81 vs. 1.46 ± 1.21), its duration (3.78 ± 5.09 vs. 7.97 ± 5.55 min), and severity (2.43 ± 2.84 vs. 4.61 ± 2.85), and in the frequency of vomiting episodes (0.17 ±.46 vs. 0.73 ±.60) in the first four hours after extubation (P < 0.05). Conclusion: Peppermint essential oil inhalation has beneficial effects on reducing nausea and vomiting after open-heart surgery. Using peppermint essential oil inhalation for managing postoperative nausea and vomiting is recommended.",2020,The two groups did not significantly differ in terms of their baseline demographic and clinical variables (P > 0.05).,"['patients undergone coronary artery bypass graft surgery', 'after cardiac surgery', '60 cardiac surgery patients', 'patients who underwent cardiac surgery']","['nebulizer aromatherapy with peppermint essential oil', 'peppermint essential oil inhalation', 'Peppermint essential oil inhalation', 'aromatherapy with peppermint essential oil']","['postoperative nausea and vomiting', ' Postoperative nausea and vomiting', 'frequency of nausea', 'nausea and vomiting', 'frequency of vomiting episodes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0070324', 'cui_str': 'Peppermint preparation'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",60.0,0.080618,The two groups did not significantly differ in terms of their baseline demographic and clinical variables (P > 0.05).,"[{'ForeName': 'Mahla', 'Initials': 'M', 'LastName': 'Maghami', 'Affiliation': 'Trauma Nursing Research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Afazel', 'Affiliation': 'Trauma Nursing Research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Azizi-Fini', 'Affiliation': 'Trauma Nursing Research Center, Faculty of Nursing and Midwifery, Kashan University of Medical Sciences, Kashan, Iran. Electronic address: azizifinies@yahoo.com.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Maghami', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan university of Medical sciences, Isfahan, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101199']
2161,32891281,Yogic meditation improves objective and subjective sleep quality of healthcare professionals.,"OBJECTIVE


Our aim was to evaluate the impact of yogic meditation in sleep quality of healthy pediatric healthcare professionals.
METHOD


Subjects were randomized into a meditation group (MG, n = 32), who attended a yogic meditation class held for eight weeks, or a control group (CG, n = 32). Polysomnography (PSG) and Pittsburgh Sleep Quality Index (PSQI) scores were determined at baseline and after eight weeks.
RESULTS


The PSQI overall score was lower (p = 0.024) in the MG. Reported sleep latency (p = 0.046) and MG sleep latency (p = 0.028) were lower in the MG at eight weeks. PSG showed a time effect (p = 0.020) on decreasing minutes of wake after sleep onset in the MG. There were strong and significant correlations between PSG and PSQI variables. There was a significant time effect on heart rate (p = 0.001) in the MG.
CONCLUSION


Yogic meditation may be used as an integrative health tool to foster improvements in the health-related aspects of healthcare professionals' lives.
TRIAL REGISTRATION


CinicalTrials.gov identifier: NCT02947074; trial registry name: Meditation Practice in Pediatric Healthcare Professionals: A Randomized Controlled Clinical Trial.",2020,Reported sleep latency (p = 0.046) and MG sleep latency (p = 0.028) were lower in the MG at eight weeks.,"['healthcare professionals', 'Pediatric Healthcare Professionals', 'Subjects', 'healthy pediatric healthcare professionals']","['Yogic meditation', 'meditation group (MG, n\xa0=\xa032), who attended a yogic meditation class', 'yogic meditation']","['PSQI overall score', 'MG sleep latency', 'time effect', 'Polysomnography (PSG) and Pittsburgh Sleep Quality Index (PSQI', 'heart rate', 'sleep latency', 'objective and subjective sleep quality']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0786021,Reported sleep latency (p = 0.046) and MG sleep latency (p = 0.028) were lower in the MG at eight weeks.,"[{'ForeName': 'Priscilla Caetano', 'Initials': 'PC', 'LastName': 'Guerra', 'Affiliation': 'Pediatric Rheumatology Unit, Department of Paediatrics, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), Rua Borges Lagoa 802, CEP 04038-001, São Paulo, Brazil.'}, {'ForeName': 'Danilo F', 'Initials': 'DF', 'LastName': 'Santaella', 'Affiliation': 'Sports Center, University of São Paulo (CEPEUSP), Rua Rio Doce 27, CEP 06350-030, Brazil.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': ""D'Almeida"", 'Affiliation': 'Department of Psychobiology, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros 925, 3rd, Floor, CEP 04024-002, São Paulo, Brazil.'}, {'ForeName': 'Rogerio', 'Initials': 'R', 'LastName': 'Santos-Silva', 'Affiliation': 'Department of Psychobiology, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros 925, 3rd, Floor, CEP 04024-002, São Paulo, Brazil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Department of Psychobiology, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), Rua Napoleão de Barros 925, 3rd, Floor, CEP 04024-002, São Paulo, Brazil.'}, {'ForeName': 'Claudio Arnaldo', 'Initials': 'CA', 'LastName': 'Len', 'Affiliation': 'Pediatric Rheumatology Unit, Department of Paediatrics, Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP), Rua Borges Lagoa 802, CEP 04038-001, São Paulo, Brazil. Electronic address: claudiolen@gmail.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101204']
2162,32891284,Preventive effect of extra virgin olive oil on pressure injury development: A randomized controlled trial in Turkey.,"BACKGROUND AND PURPOSE


Different moisturizing products are used in the prevention of pressure injuries, but there is a limited number of studies on the effectiveness of extra virgin olive oil, which is an herbal and natural product. The aim of this study was to examine the effect of topically applied extra virgin olive oil on the prevention of pressure injuries.
METHODS AND MATERIALS


This was a randomized controlled experimental study conducted between February and October 2015 with a total of 129 patients, of whom 64 were in the control group and 65 in the extra virgin olive oil group.
RESULTS


16.9% of patients in the extra virgin olive oil group (n = 11) and 32.8% of patients in the control group (n = 21) developed pressure injuries, and the difference was found to be statistically significant.
CONCLUSION


This study showed that the application of extra virgin olive oil is effective in preventing pressure injuries.",2020,"RESULTS


16.9% of patients in the extra virgin olive oil group (n = 11) and 32.8% of patients in the control group (n = 21) developed pressure injuries, and the difference was found to be statistically significant.
","['Turkey', 'February and October 2015 with a total of 129 patients, of whom 64 were in the control group and 65 in the extra virgin olive oil group']",['extra virgin olive oil'],"['pressure injury development', 'pressure injuries']","[{'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",129.0,0.0587699,"RESULTS


16.9% of patients in the extra virgin olive oil group (n = 11) and 32.8% of patients in the control group (n = 21) developed pressure injuries, and the difference was found to be statistically significant.
","[{'ForeName': 'Münevver', 'Initials': 'M', 'LastName': 'Sönmez', 'Affiliation': 'Zonguldak Bülent Ecevit University, Faculty of Health Science, Fundamentals of Nursing Department, 67000, Zonguldak, Turkey. Electronic address: m.sonmez@beun.edu.tr.'}, {'ForeName': 'Ülkü', 'Initials': 'Ü', 'LastName': 'Yapucu Güneş', 'Affiliation': 'Ege University, Nursing Faculty, Fundamentals of Nursing Department, İzmir, Turkey.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101208']
2163,32891292,The effect of music therapy on physiological parameters of patients with traumatic brain injury: A triple-blind randomized controlled clinical trial.,"OBJECTIVE


This study aims to investigate the effect of music therapy integrated with family recollection on physiological parameters of patients with traumatic brain injury who are admitted to Intensive Care Units.
METHODS


Sixty patients were selected through convenience sampling and were then randomly assigned to the intervention group and control group. In the intervention group and for 6 consecutive days, the patients received a combination of music and auditory stimulation twice a day for 15 minutes. The patients' physiological parameters were measured before the intervention, and then 10 minutes and finally 30 minutes after the intervention. The data were analyzed using multilevel modeling method through MLwiN version 2.27.
RESULTS


The results showed that there was no significant difference between the two groups in terms of demographic factors and the duration of coma. However, the results of the two-level multiple linear models which were performed for 6 consecutive days indicated a significant decrease in systolic blood pressure, diastolic blood pressure, respiratory rate and heart rate for the patients in the intervention group as compared to the patients in the control group (P < 0.0001). Nevertheless, no significant difference was observed in temperature and oxygen saturation (P > 0.05).
CONCLUSION


Integration of music therapy with family recollection can moderate physiological parameters. Therefore, it is recommended to use this cost-effective treatment along with the routine treatments, especially for patients with traumatic brain injury.",2020,The results showed that there was no significant difference between the two groups in terms of demographic factors and the duration of coma.,"['patients with traumatic brain injury who are admitted to Intensive Care Units', 'Sixty patients were selected through convenience sampling', 'patients with traumatic brain injury']","['music therapy', 'music therapy integrated with family recollection', 'combination of music and auditory stimulation']","['demographic factors and the duration of coma', 'temperature and oxygen saturation', 'systolic blood pressure, diastolic blood pressure, respiratory rate and heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0001164', 'cui_str': 'Stimulation, Acoustic'}]","[{'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",60.0,0.0452672,The results showed that there was no significant difference between the two groups in terms of demographic factors and the duration of coma.,"[{'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Froutan', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Iran; Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Eghbali', 'Affiliation': 'Department of Nursing, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran; Student Research Committee, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Hamid', 'Initials': 'SH', 'LastName': 'Hoseini', 'Affiliation': 'School of Nursing and Midwifery, Torbat Heydariyeh University of Medical Sciences, Iran. Electronic address: hamidhoseini47@yahoo.com.'}, {'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Mazloom', 'Affiliation': 'Department of Medical Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Boostani', 'Affiliation': 'Department of Neurology, School of Medicine Ghaem Hospital, Mashhad University of Medical Sciences, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101216']
2164,32891336,Functional jejunal interposition versus Roux-en-Y anastomosis after total gastrectomy for gastric cancer: A prospective randomized clinical trial.,"BACKGROUND


Nutritional status and quality of life deteriorate significantly after total gastrectomy for patients with gastric cancer. The numerous types of reconstruction proposed by medical researchers around the world have limited effect. This prospective, randomized clinical trial compared functional jejunal interposition with Roux-en-Y anastomosis to identify the optimal reconstruction procedure.
METHODS


This was a multi-center, prospective, randomized control trial. The enrolled patients were randomly assigned into the functional jejunal interposition group and the Roux-en-Y group. All patients were followed up at regular intervals after surgery. The endpoints were postoperative nutritional status, quality of life, and long-term postoperative complications.
RESULTS


A total of 113 patients were enrolled from August 2012 to September 2017. Until March 2018, the median follow-up period was 18 months. At 12 months after surgery, food intake per meal (P = 0.021), Prognosis Nutritional Index (P = 0.015), weight loss (P = 0.019), and Gastrointestinal Symptom Rating Scale score (P = 0.015) of the functional jejunal interposition group were significantly worse than those of the Roux-en-Y group. There was no significant difference in operative time, intraoperative blood loss, perioperative complications, time of first flatus and defecation after surgery, postoperative plasma nutritional parameters, Visick score, Eastern Cooperative Group physical condition score, and survival rate.
CONCLUSION


For patients with long-term survival after total gastrectomy for gastric cancer, the Roux-en-Y anastomosis is a better choice compared with functional jejunal interposition.",2020,"There was no significant difference in operative time, intraoperative blood loss, perioperative complications, time of first flatus and defecation after surgery, postoperative plasma nutritional parameters, Visick score, Eastern Cooperative Group physical condition score, and survival rate.
","['A total of 113 patients were enrolled from August 2012 to September 2017', 'patients with gastric cancer', 'patients with long-term survival after total gastrectomy for gastric cancer', 'gastric cancer']","['functional jejunal interposition with Roux-en-Y anastomosis', 'functional jejunal interposition group and the Roux-en-Y group', 'total gastrectomy', 'Functional jejunal interposition versus Roux-en-Y anastomosis after total gastrectomy']","['postoperative nutritional status, quality of life, and long-term postoperative complications', 'weight loss', 'operative time, intraoperative blood loss, perioperative complications, time of first flatus and defecation after surgery, postoperative plasma nutritional parameters, Visick score, Eastern Cooperative Group physical condition score, and survival rate', 'Gastrointestinal Symptom Rating Scale score', 'Prognosis Nutritional Index']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0399643', 'cui_str': 'Jejunal interposition'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0028710', 'cui_str': 'Nutrition Index'}]",113.0,0.0255822,"There was no significant difference in operative time, intraoperative blood loss, perioperative complications, time of first flatus and defecation after surgery, postoperative plasma nutritional parameters, Visick score, Eastern Cooperative Group physical condition score, and survival rate.
","[{'ForeName': 'Huashe', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Xiansheng', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Zuli', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastropancreatic Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastropancreatic Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, China.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Yonghe', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Institute of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, 510655, China. Electronic address: pengjsh@mail.sysu.edu.cn.'}]",Surgical oncology,['10.1016/j.suronc.2020.04.023']
2165,32891342,Tumescent technique versus electrocautery mastectomy: A randomized controlled trial.,"BACKGROUND


Breast cancer is the most common cancer in Danish women. In 2016 about 1450 (31%) Danish breast cancer patients had a mastectomy. The aim was to compare the frequency of postoperative complications in two methods of surgery, electrocautery dissection and tumescent technique, when performing a mastectomy.
METHODS


Open randomized controlled trial of all consecutive primary breast cancer or DCIS female patients who underwent either a simple mastectomy or a modified radical mastectomy in Vejle Hospital, from January 2012 to October 2017. Primary outcomes were seroma production, bleeding, infection and necrosis. Secondary outcomes were duration of surgery and delay of adjuvant treatment caused by complications. Categorical outcome variables were compared between randomization groups using chi-square of Fisher exact test and continuous outcome variables by using Wilcoxon rank test. All analyses were performed at a 5% two-sided significance level.
RESULTS


357 patients met the inclusion criteria. 14 had bilateral mastectomy, i.e. 371 breasts. The two randomization groups consisted of 105 patients/107 breasts operated by tumescent technique and 98 patients/102 breasts operated by electrocautery technique. Tumescent technique produced more seroma though not significant (p = 0.631) (mean 605 vs. 630 ml). Bleeding in the tumescent group was 10.3% vs. 5.9% in the electrocautery group (p = 0.245). Infection (5.9% vs. 7.5% p = 0.645) and necrosis (4.9% vs. 4.7% p = 0.938) was uncommon with no difference between the intervention groups. Infection was most common cause of delay of adjuvant treatment; 3.9% in the electrocautery technique group. No significant difference in duration of surgery (p = 0.392).
CONCLUSION


Both techniques are equally safe for simple and modified radical mastectomy.",2020,Tumescent technique produced more seroma though not significant (p = 0.631) (mean 605 vs. 630 ml).,"['in Vejle Hospital, from January 2012 to October 2017', '357 patients met the inclusion criteria', 'Danish breast cancer patients had a mastectomy', 'Danish women', 'all consecutive primary breast cancer or DCIS female patients who underwent either a', '14 had bilateral mastectomy, i.e. 371 breasts']","['Tumescent technique versus electrocautery mastectomy', 'surgery, electrocautery dissection and tumescent technique', '105 patients/107 breasts operated by tumescent technique and 98 patients/102 breasts operated by electrocautery technique', 'simple mastectomy or a modified radical mastectomy']","['seroma production, bleeding, infection and necrosis', 'Bleeding', 'duration of surgery and delay of adjuvant treatment caused by complications', 'necrosis', 'duration of surgery', 'Infection']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0191877', 'cui_str': 'Bilateral mastectomy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0880421,Tumescent technique produced more seroma though not significant (p = 0.631) (mean 605 vs. 630 ml).,"[{'ForeName': 'Marianne Djernes', 'Initials': 'MD', 'LastName': 'Lautrup', 'Affiliation': 'Department of Surgery, Lillebaelt Hospital, Beriderbakken 4, 7100, Vejle, Denmark. Electronic address: Marianne.korsgaard@dadlnet.dk.'}, {'ForeName': 'Jorn Bo', 'Initials': 'JB', 'LastName': 'Thomsen', 'Affiliation': 'Department of Plastic Surgery, Lillebaelt Hospital, Beriderbakken 4, 7100, Vejle, Denmark; Odense University Hospital, J.B. Winslows Vej 4, 5000, Odense C, Denmark. Electronic address: jornbothomsen@gmail.com.'}, {'ForeName': 'René Depont', 'Initials': 'RD', 'LastName': 'Christensen', 'Affiliation': 'Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark. Electronic address: depont42@gmail.com.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kjaer', 'Affiliation': 'Department of Surgery, Lillebaelt Hospital, Beriderbakken 4, 7100, Vejle, Denmark. Electronic address: Christina.kjaer1@rsyd.dk.'}]",Surgical oncology,['10.1016/j.suronc.2020.05.003']
2166,32891418,"Efficacy and Tolerability of Pitavastatin Versus Pitavastatin/Fenofibrate in High-risk Korean Patients with Mixed Dyslipidemia: A Multicenter, Randomized, Double-blinded, Parallel, Therapeutic Confirmatory Clinical Trial.","PURPOSE


Dyslipidemia is an important risk factor for cardiovascular disease (CVD). Statins are known to effectively reduce not only low-density lipoprotein cholesterol (LDL-C) level but also death and nonfatal myocardial infarction due to coronary heart disease. The risk for CVD from atherogenic dyslipidemia persists when elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels are not controlled with statin therapy. Therefore, statin/fenofibrate combination therapy is more effective in reducing CVD risk. Here, we assessed the efficacy and tolerability of pitavastatin/fenofibrate combination therapy in patients with mixed dyslipidemia and a high risk for CVD.
METHODS


This multicenter, randomized, double-blind, parallel-group, therapeutic-confirmatory clinical trial evaluated the efficacy and tolerability of fixed-dose combination therapy with pitavastatin/fenofibrate 2/160 mg in Korean patients with a high risk for CVD and a controlled LDL-C level (<100 mg/dL) and a TG level of 150-500 mg/dL after a run-in period with pitavastatin 2 mg alone. In the 8-week main study, 347 eligible patients were randomly assigned to receive pitavastatin 2 mg with or without fenofibrate 160 mg after a run-in period. In the extension study, patients with controlled LDL-C and non-HDL-C (<130 mg/dL) levels were included after the completion of the main study. All participants in the extension study received the pitavastatin/fenofibrate combination therapy for 16 weeks for the assessment of the tolerability of long-term treatment.
FINDINGS


The difference in the mean percentage change in non-HDL-C from baseline to week 8 between the combination therapy and monotherapy groups was -12.45% (95% CI, -17.18 to -7.72), and the combination therapy was associated with a greater reduction in non-HDL-C. The changes in lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein from baseline to weeks 4 and 8 were statistically significant with combination therapy compared to monotherapy at all time points. Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively. The combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy.
IMPLICATIONS


In these Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with pitavastatin/fenofibrate was associated with a greater reduction in non-HDL-C compared with that with pitavastatin monotherapy, and a significantly improvement in other lipid levels. Moreover, the combination therapy was well tolerated, with a safety profile similar to that of statin monotherapy. Therefore, pitavastatin/fenofibrate combination therapy could be effective and well tolerated in patients with mixed dyslipidemia. ClinicalTrials.gov identifier: NCT03618797.",2020,"Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively.","['347 eligible patients', 'Korean patients with mixed dyslipidemia and a high risk for CVD, combination therapy with', 'patients with mixed dyslipidemia', 'Korean patients with a high risk for CVD and a controlled LDL-C level (<100\xa0mg/dL) and a TG level of 150-500\xa0mg/dL after a run-in period with', 'patients with controlled LDL-C and non-HDL-C (<130\xa0mg/dL) levels were included after the completion of the main study', 'High-risk Korean Patients with Mixed Dyslipidemia', 'patients with mixed dyslipidemia and a high risk for CVD']","['pitavastatin/fenofibrate', 'statin/fenofibrate combination therapy', 'Pitavastatin Versus Pitavastatin/Fenofibrate', 'pitavastatin 2\xa0mg with or without fenofibrate', 'pitavastatin monotherapy', 'pitavastatin 2\xa0mg alone', 'pitavastatin/fenofibrate combination therapy']","['lipid profile, including apolipoproteins, fibrinogen, and high-sensitivity C-reactive protein', 'effective and well tolerated', 'rates of achievement of non-HDL-C and apolipoprotein B targets', 'Efficacy and Tolerability', 'elevated triglyceride (TG) and reduced high-density lipoprotein cholesterol (HDL-C) levels', 'lipid levels', 'low-density lipoprotein cholesterol (LDL-C) level', 'CVD risk', 'efficacy and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",347.0,0.0832424,"Furthermore, the rates of achievement of non-HDL-C and apolipoprotein B targets at week 8 in the combination therapy and monotherapy groups were 88.30% versus 77.98% (P = 0.0110) and 78.94% versus 68.45% (P = 0.0021), respectively.","[{'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Ihm', 'Affiliation': ""Department of Internal Medicine, Bucheon St. Mary's Hospital, Bucheon, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Woo-Baek', 'Initials': 'WB', 'LastName': 'Chung', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Uijeongbu St. Mary's Hospital, Uijeongbu, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Byung-Hee', 'Initials': 'BH', 'LastName': 'Hwang', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Ki-Dong', 'Initials': 'KD', 'LastName': 'Yoo', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, Suwon, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Her', 'Affiliation': ""Department of Internal Medicine, St. Vincent's Hospital, Suwon, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Woo-Hyuk', 'Initials': 'WH', 'LastName': 'Song', 'Affiliation': 'Department of Internal Medicine, Ansan Hospital, Korea University, Ansan, South Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Chae', 'Affiliation': 'Department of Internal Medicine, Bundang Hospital, College of Medicine, Seoul National University, Seongnam, South Korea.'}, {'ForeName': 'Tae-Ho', 'Initials': 'TH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Dong-A University Hospital, Busan, South Korea.'}, {'ForeName': 'Ju-Han', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chonnam National University Hospital, Gwangju, South Korea.'}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'Department of Internal Medicine, National Health Insurance Service, Ilsan Hospital, Goyang, South Korea.'}, {'ForeName': 'Byung-Ryul', 'Initials': 'BR', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangwon National University Hospital, Kangwon National University, Chuncheon, South Korea.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Cheju Halla General Hospital, Jeju, South Korea.'}, {'ForeName': 'Sang-Don', 'Initials': 'SD', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inha University Hospital, Incheon, South Korea.'}, {'ForeName': 'Jin-Bae', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, South Korea.'}, {'ForeName': 'Jeong-Taek', 'Initials': 'JT', 'LastName': 'Woo', 'Affiliation': 'Department of Internal Medicine, Kyunghee University Medical Center, Seoul, South Korea.'}, {'ForeName': 'Byung-Wan', 'Initials': 'BW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Kyung-Ah', 'Initials': 'KA', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University, Seoul, South Korea.'}, {'ForeName': 'Kyung-Heon', 'Initials': 'KH', 'LastName': 'Won', 'Affiliation': 'Department of Internal Medicine, Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hyo-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, College of Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Jae-Myung', 'Initials': 'JM', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea.'}, {'ForeName': 'Choon Hee', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, South Korea.'}, {'ForeName': 'Hae-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'Ho-Chan', 'Initials': 'HC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Dongsan Hospital, Keimyung University, Daegu, South Korea.'}, {'ForeName': 'Ki-Bae', 'Initials': 'KB', 'LastName': 'Seung', 'Affiliation': ""Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, South Korea; College of Medicine, The Catholic University of Korea, Seoul, South Korea. Electronic address: kbseung0217@gmail.com.""}]",Clinical therapeutics,['10.1016/j.clinthera.2020.08.002']
2167,32896390,Low-dose aspirin in reproductive health: effects on menstrual cycle characteristics.,"OBJECTIVE


To estimate the effect of daily 81 mg low-dose aspirin (LDA) on menstrual cycle length and hormone profiles.
DESIGN


Secondary analysis of a trial evaluating the effect of daily LDA or placebo on live birth among women with one or two previous pregnancy losses.
SETTING


University medical centers.
PATIENT(S)


A total of 915 regularly menstruating women who had at least one menstrual cycle (3,190 total cycles) in which pregnancy did not occur.
INTERVENTION(S)


Randomized allocation to LDA versus placebo.
MAIN OUTCOME MEASURE(S)


Menstrual cycle length and follicular and luteal phases were measured. Urinary pregnanediol glucuronide, follicle-stimulating hormone, luteinizing hormone, and estrone-3-glucuronide were assessed up to six times during the first two cycles. Generalized estimating equations estimated relative risk of short (<25th percentile: <27 days) and long (>75th percentile: ≥32 days) versus normal cycle length. Linear mixed models estimated mean hormone level differences with weights used to account for multiple cycles contributed per participant.
RESULT(S)


There were no significant differences in total menstrual cycle, follicular phase, or luteal phase length between LDA and placebo groups. LDA posed no greater risk of having a short versus normal-length or long versus normal-length follicular phase, or having a short versus normal-length or long versus normal-length luteal phase. There were no significant differences in hormone levels across the menstrual cycle between the LDA and placebo groups.
CONCLUSION(S)


Daily LDA use did not result in any changes to menstrual cycle, follicular phase, or luteal phase length or hormone levels across the menstrual cycle compared with placebo.
CLINICAL TRIAL REGISTRATION NUMBER


NCT00467363.",2020,"There were no significant differences in total menstrual cycle, follicular phase, or luteal phase length between LDA and placebo groups.","['University medical centers', '915 regularly menstruating women who had at least one menstrual cycle (3,190 total cycles) in which pregnancy did not occur', 'women with one or two previous pregnancy losses', 'reproductive health']","['daily 81 mg low-dose aspirin (LDA', 'LDA or placebo', 'LDA versus placebo', 'LDA', 'Low-dose aspirin']","['Menstrual cycle length and follicular and luteal phases', 'total menstrual cycle, follicular phase, or luteal phase length', 'Urinary pregnanediol glucuronide, follicle-stimulating hormone, luteinizing hormone, and estrone-3-glucuronide', 'menstrual cycle length and hormone profiles', 'hormone levels', 'live birth', 'menstrual cycle, follicular phase, or luteal phase length or hormone levels']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0425934', 'cui_str': 'Measure of duration of menstrual cycle'}, {'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0071863', 'cui_str': 'pregnanediol-3 alpha-glucuronide'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0059670', 'cui_str': 'estrone-3-glucuronide'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",915.0,0.456971,"There were no significant differences in total menstrual cycle, follicular phase, or luteal phase length between LDA and placebo groups.","[{'ForeName': 'M Blake', 'Initials': 'MB', 'LastName': 'Evans', 'Affiliation': 'Program in Reproductive Endocrinology and Gynecology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Micah J', 'Initials': 'MJ', 'LastName': 'Hill', 'Affiliation': 'Program in Reproductive Endocrinology and Gynecology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'DeCherney', 'Affiliation': 'Program in Reproductive Endocrinology and Gynecology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Program in Reproductive Endocrinology and Gynecology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland. Electronic address: schistee@mail.nih.gov.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.06.022']
2168,32896456,Usefulness of quantitative hepatitis B surface antigen testing in hepatitis B community-based screening.,"BACKGROUND/PURPOSE


Low viral load (LVL) of hepatitis B virus (HBV) is a predictor of chronic HBV infection. However, the usefulness of quantitative hepatitis B surface antigen (qHBsAg) in predicting LVL in community-based screening has not been well studied. We aimed to measure the prevalence of LVL in HBV carriers and validate the efficacy of qHBsAg in predicting LVL.
METHODS


This community-based screening study was conducted in Taiwan. HBV DNA was assayed in HBsAg carriers. Participants were randomized to training and validation sets to determine the ability of qHBsAg to predict LVL. Receiver operating characteristic curves were used to identify the best cutoff values in the training set.
RESULTS


Among the 2919 participants, 359 (12.2%) were HBsAg carriers. There were 132 and 137 carriers in the training and validation sets, respectively. Significant correlations were found between qHBsAg and HBV DNA in both training and validation sets. Thirty and 29 participants with qHBsAg <8 IU/mL in the training and validation sets, respectively, had LVL. Using 8 IU/mL as the cutoff, negative predictive value (NPV) of qHBsAg for HBV DNA levels >2000 IU/mL was 100%. The best cutoff level of qHBsAg to predict HBV LVL was 200 IU/mL, with a sensitivity, specificity, and accuracy of 75.0%, 76.1%, and 75.8%, respectively, in the training set. The positive predictive value and NPV were 70.0% and 77.9%, respectively, in the validation set.
CONCLUSION


Approximately 60% of HBsAg carriers had HBV LVL, and qHBsAg <8 IU/mL accurately predicts LVL. This quantitative test provides additional information for community-based screening.",2020,"The positive predictive value and NPV were 70.0% and 77.9%, respectively, in the validation set.
","['Thirty and 29 participants with qHBsAg', 'This community-based screening study was conducted in Taiwan', 'hepatitis B community-based screening', '2919 participants, 359 (12.2%) were HBsAg carriers']","['quantitative hepatitis B surface antigen testing', 'quantitative hepatitis B surface antigen (qHBsAg']","['HBV DNA', 'positive predictive value and NPV', 'HBV LVL, and qHBsAg', 'qHBsAg and HBV DNA']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}]",2919.0,0.053115,"The positive predictive value and NPV were 70.0% and 77.9%, respectively, in the validation set.
","[{'ForeName': 'Kao-Chi', 'Initials': 'KC', 'LastName': 'Chang', 'Affiliation': 'Division of Hepatology and Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Chih-Yi', 'Initials': 'CY', 'LastName': 'Lee', 'Affiliation': 'Department of Laboratory Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Te-Sheng', 'Initials': 'TS', 'LastName': 'Chang', 'Affiliation': 'Division of Hepatology and Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan; Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Yunlin, Taiwan; School of Medicine, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chao-Hung', 'Initials': 'CH', 'LastName': 'Hung', 'Affiliation': 'Department of Internal Medicine, Division of Hepato-Gastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan.'}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Chen', 'Affiliation': 'Division of Hepatology and Gastroenterology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Mei-Yen', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'College of Nursing, Chang Gung University of Science and Technology, Chiayi, Taiwan.'}, {'ForeName': 'Tung-Jung', 'Initials': 'TJ', 'LastName': 'Huang', 'Affiliation': 'Division of Thoracic Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Wen-Nan', 'Initials': 'WN', 'LastName': 'Chiu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Jing-Hong', 'Initials': 'JH', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Yu-Chih', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Division of Family Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'Huang', 'Affiliation': 'Department of Geriatric, Chang Gung Memorial Hospital, Chiayi, Taiwan.'}, {'ForeName': 'Nien-Tzu', 'Initials': 'NT', 'LastName': 'Hsu', 'Affiliation': 'Biostatistics and Bioinformatics Center of Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Sheng-Nan', 'Initials': 'SN', 'LastName': 'Lu', 'Affiliation': 'Department of Internal Medicine, Division of Hepato-Gastroenterology, Kaohsiung Chang Gung Memorial Hospital, Taiwan; Biostatistics and Bioinformatics Center of Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. Electronic address: juten@ms17.hinet.net.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.08.031']
2169,32896644,Transcranial direct current stimulation: a novel approach in the treatment of vascular depression.,"BACKGROUND


Despite the impact of depression in terms of personal suffering and socioeconomic burden, most currently available treatment options are often ineffective. A particularly difficult-to-treat depressive disorder characteristic of the elderly is vascular depression, a late-life depressive syndrome related to a variety of potential vascular mechanisms. Transcranial Direct Current Stimulation (tDCS), a non-invasive and effective somatic approach to depression, has also been shown positive effect on cognitive deficits.
AIM


We performed a double-blind randomized study to investigate the efficacy of tDCS as augmentations strategy to sertraline in the treatment of vascular depression, hypothesizing a positive effect in both depressive symptoms and cognitive functions.
METHODS


We enrolled 93 inpatients over 60 years of age with a diagnosis of vascular depression. Depressive symptoms were weekly assessed (T0, T1, T2) with the 21-items Hamilton depression rating scale (HDRS). Cognitive functioning has been evaluated with the Milan Overall Dementia Assessment (MODA) at baseline and after the treatment protocol. All patients were randomly assigned into three groups, Group I: one tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day. Stimulation was performed for 10 consecutive working days.
RESULTS


A significant interaction time*treatment was observed on HDRS scores (F=14, p<0.001). All groups improved at T1 but whereas Group II significantly differed from the Sham group (p<0.001) we observed no difference between Sham and Group I. At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001; vs. Group I p<0.001) and the Sham group the smallest (vs. Group I p=0.005). A significant interaction time*treatment was also observed on MODA scores (F=3.31, p=.04). Only subjects treated with tDCS improved at T2 (Group I: p<0.001; Group II: p=0.007). However, no difference between Group I and II was shown.
CONCLUSION


tDCS as augmentation treatment of an adequate pharmacotherapy is a potential strategy in the management of vascular depression, disease known to be often unresponsive to antidepressants only. Non-invasiveness, the absence of severe side effects and the possibility of administering it to outpatients at an affordable price make tDCS an important tool in clinical practice.",2020,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,['93 inpatients over 60 years of age with a diagnosis of vascular depression'],"['sertraline', 'tDCS stimulation per day, Group II: two tDCS stimulations per day, Sham group: one sham tDCS stimulation per day', 'Transcranial Direct Current Stimulation (tDCS', 'Transcranial direct current stimulation', 'tDCS']","['MODA scores', 'Depressive symptoms', '21-items Hamilton depression rating scale (HDRS', 'HDRS scores']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.13066,At T2 all groups improved but Group II showed the greater improvement (vs. Sham p<0.001;,"[{'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Zanardi', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Milan, Italy. Electronic address: zanardi.raffaella@hsr.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Poletti', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prestifilippo', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Attanasio', 'Affiliation': 'University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barbini', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Milan, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Colombo', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Department of Clinical Neurosciences, Milan, Italy; University Vita-Salute San Raffaele, Department of Clinical Neurosciences, Milan, Italy.'}]",Brain stimulation,['10.1016/j.brs.2020.08.013']
2170,32896653,"Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial.","OBJECTIVES


Protection induced by acellular vaccines can be short, requiring novel immunisation strategies. Objectives of this study were to evaluate safety and capacity of a recombinant pertussis toxin (PTgen)-coated Viaskin® epicutaneous patch to recall memory responses in healthy adults.
METHODS


This double-blind, placebo-controlled randomized trial (Phase I) assessed the safety and immunogenicity of PTgen administered on days 0 and 14 to healthy adults using Viaskin® patches applied directly or after epidermal laser-based skin preparation. Patch administration was followed by Boostrix®dTpa on day 42. Antibodies were assessed at days 0, 14, 28, 42, and 70.
RESULTS


Among 102 volunteers enrolled, 80 received Viaskin-PT (Viaskin-PT 25μg [n=25], Viaskin-PT 50μg [n=25], laser+Viaskin-PT 25μg [n=5], laser+Viaskin-PT 50μg [n=25]), Viaskin-placebo [n=10] or laser+Viaskin-placebo [n=12]). Incidence of adverse events was similar across groups (any local event: 21/25 [84·0%], 24/25 [96·0%], 4/5 [80·0%], 24/25 [96·0%], 8/10 [80·0%], 10/12 [83·0%] respectively). Direct application induced no detectable response. On day 42, PT-IgG geometric mean concentrations were significantly higher following laser+Viaskin-PT 25μg and 50 μg (139·87 [95% CI 87·30-224·10] and 121·76 [95% CI 95·04-156·00], respectively, than laser+Viaskin-placebo (59·49 [95% CI 39·37-89·90]). Seroresponse rates were higher following laser+Viaskin-PT 25μg (4/5 (80.0%) [95% CI 28·4 - 99.5]) and 50μg (22/25 (88.0%) [95% CI 68.8 - 97.5]) than laser+Viaskin-placebo (0/12 (0·0%) [95% CI 0.0 - 26.5].
CONCLUSIONS


Viaskin-PT applied after laser-based epidermal skin preparation showed encouraging safety and immunogenicity results: anti-PT booster responses were not inferior to those elicited by Boostrix®dTpa. This study is registered at ClinicalTrials.gov (NCT03035370) and was funded by DBV Technologies.",2020,"On day 42, PT-IgG geometric mean concentrations were significantly higher following laser+Viaskin-PT 25μg and 50 μg (139·87 [95% CI 87·30-224·10] and 121·76 [95% CI 95·04-156·00], respectively, than laser+Viaskin-placebo (59·49 [95% CI 39·37-89·90]).","['102 volunteers enrolled, 80 received', 'healthy adults using Viaskin® patches applied directly or after epidermal laser-based skin preparation', 'healthy adults', 'n=12']","['laser+Viaskin-placebo', 'Viaskin-placebo', 'Viaskin-PT (Viaskin-PT 25μg', 'recombinant pertussis toxin (PTgen)-coated Viaskin® epicutaneous patch', 'laser+Viaskin-PT 25μg [n=5], laser+Viaskin-PT 50μg', 'PTgen', 'placebo', 'Viaskin-PT 50μg ']","['Incidence of adverse events', 'Safety and immunogenicity', 'Seroresponse rates', 'PT-IgG geometric mean concentrations', 'safety and immunogenicity']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0455085', 'cui_str': 'Skin preparation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020731', 'cui_str': 'Pertussis toxin'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",102.0,0.661763,"On day 42, PT-IgG geometric mean concentrations were significantly higher following laser+Viaskin-PT 25μg and 50 μg (139·87 [95% CI 87·30-224·10] and 121·76 [95% CI 95·04-156·00], respectively, than laser+Viaskin-placebo (59·49 [95% CI 39·37-89·90]).","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Chatzis', 'Affiliation': 'Center for Vaccinology, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Blanchard-Rohner', 'Affiliation': 'Center for Vaccinology, University Hospitals of Geneva, Switzerland; Division of General Pediatrics, Department of Pediatrics, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mondoulet', 'Affiliation': 'DBV Technologies, 177-181, avenue Pierre Brossolette, 92120, Montrouge, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Pelletier', 'Affiliation': 'DBV Technologies, 177-181, avenue Pierre Brossolette, 92120, Montrouge, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'De Gea-Hominal', 'Affiliation': 'Center for Vaccinology, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roux', 'Affiliation': 'DBV Technologies, 177-181, avenue Pierre Brossolette, 92120, Montrouge, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Center for Vaccinology, University Hospitals of Geneva, Switzerland; Division of Infectious Diseases, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hervé', 'Affiliation': 'DBV Technologies, 177-181, avenue Pierre Brossolette, 92120, Montrouge, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rohr', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Matthey', 'Affiliation': 'Center for Clinical Research, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gutknecht', 'Affiliation': 'Center for Clinical Research, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lemaître', 'Affiliation': 'Laboratory of Vaccinology, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hayem', 'Affiliation': 'DBV Technologies, 177-181, avenue Pierre Brossolette, 92120, Montrouge, France.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Pham', 'Affiliation': 'BioNet-Asia Co.Ltd., Bangkok, Thailand.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wijagkanalan', 'Affiliation': 'BioNet-Asia Co.Ltd., Bangkok, Thailand.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Lambert', 'Affiliation': 'Center for Vaccinology, University Hospitals of Geneva, Switzerland.'}, {'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Benhamou', 'Affiliation': 'DBV Technologies, 177-181, avenue Pierre Brossolette, 92120, Montrouge, France.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Siegrist', 'Affiliation': 'Center for Vaccinology, University Hospitals of Geneva, Switzerland; Division of General Pediatrics, Department of Pediatrics, University Hospitals of Geneva, Switzerland. Electronic address: Claire-Anne.Siegrist@unige.ch.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.08.033']
2171,32896692,Validation of the Musculoskeletal Health Questionnaire (MSK-HQ) in primary care patients with musculoskeletal pain.,"OBJECTIVE


To evaluate the responsiveness, and concurrent validity of the Musculoskeletal Health Questionnaire (MSK-HQ) in UK primary care patients with common musculoskeletal (MSK) pain presentations.
METHODS


A secondary analysis of a primary care pilot randomised trial (STarT MSK) was performed. In 524 people consulting with back, neck, shoulder, knee, or multi-site pain, the following were recorded at 0/6 months: MSK-HQ, EQ-5D-5L, Roland-Morris Disability Questionnaire (RMDQ; back pain), Neck Disability Index (NDI), Shoulder Pain and Disability Index (SPADI), Knee Injury and Outcome Score (KOOS), Short-Form-12 (SF-12; multisite pain). At 6-months, patients self-rated their global change in MSK condition, from -5 (""very much worse"") to +5 (""completely recovered""). Receiver operating characteristic curves evaluated abilities of 6-month changes in each patient reported outcome measure (PROM) to discriminate between patients improving/not improving on global change scores, with Minimal Clinically Important Differences (MCID) calculated.
RESULTS


The MSK-HQ had a good ability to discriminate between MSK pain patients reporting global improvement vs. no improvement (area under the curve [AUC] 0.81; 95% CI 0.78, 0.85). Its discriminative ability was higher than the EQ-5D-5L (AUC 0.68; 95% CI 0.62, 0.73) and similar to site-specific PROMs. The MCID for the 6-month change in MSK-HQ was 5.5. The MSK-HQ had strong correlations with all PROMs, except SF-12 scores.
CONCLUSION


In primary care patients with common MSK pain presentations, the MSK-HQ was as good as existing pain-site specific PROMs at identifying people reporting global improvements in their MSK condition, and was better than the EQ-5D-5L.",2020,"Its discriminative ability was higher than the EQ-5D-5L (AUC 0.68; 95% CI 0.62, 0.73) and similar to site-specific PROMs.","['524 people consulting with back, neck, shoulder, knee, or multi-site pain, the following were recorded at 0/6 months', 'primary care patients with musculoskeletal pain', 'primary care patients with common MSK pain presentations', 'UK primary care patients with common musculoskeletal (MSK) pain presentations']","['Musculoskeletal Health Questionnaire (MSK-HQ', 'EQ-5D-5L']","['global change scores', 'MSK-HQ, EQ-5D-5L, Roland-Morris Disability Questionnaire (RMDQ; back pain), Neck Disability Index (NDI), Shoulder Pain and Disability Index (SPADI), Knee Injury and Outcome Score (KOOS), Short-Form-12 (SF-12; multisite pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.135736,"Its discriminative ability was higher than the EQ-5D-5L (AUC 0.68; 95% CI 0.62, 0.73) and similar to site-specific PROMs.","[{'ForeName': 'Dr Ian C', 'Initials': 'DIC', 'LastName': 'Scott', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK; Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, UK; Haywood Academic Rheumatology Centre, Haywood Hospital, Midlands Partnership NHS Foundation Trust, High Lane, Burslem, Staffordshire, UK. Electronic address: i.scott@keele.ac.uk.'}, {'ForeName': 'Dr Gareth', 'Initials': 'DG', 'LastName': 'McCray', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Prof Gillian', 'Initials': 'PG', 'LastName': 'Lancaster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK; Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Prof Nadine E', 'Initials': 'PNE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Dr Jonathan C', 'Initials': 'DJC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.06.022']
2172,32896743,Development of a brief online intervention to address aggression in the context of emotion-related impulsivity: Evidence from a wait-list controlled trial.,"Trait-like tendencies to respond impulsively to emotion, labelled emotion-related impulsivity, are robustly related to aggression. We developed and tested an online intervention to address emotion-related impulsivity and aggression. The 6-session intervention focused on behavioral techniques shown to decrease arousal and aggression, supplemented with implementation intentions and smartphone prompts to facilitate skills transfer into daily life. First, we piloted the intervention in-person with 4 people. Then, 235 participants were randomly assigned to take the online intervention immediately or after a wait-list period; those in the waitlist were then invited to take part in the intervention. Participants completed the self-rated Feelings Trigger Action Scale to assess emotion-related impulsivity, the interview-based Modified Overt Aggression Scale and the self-rated Buss Perry Aggression Questionnaire. Participants who took part in the treatment completed daily anger logs. Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices. In analyses including all participants who took part in the treatment (immediate or delayed), we observed moderate-to-large treatment gains, which were maintained as of the 3-month follow-up assessment. This work supports the usefulness of an intervention for addressing emotion-related impulsivity and aggression.",2020,"Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices.","['Participants who took part in the treatment completed daily anger logs', '235 participants']",['brief online intervention'],"['self-rated Feelings Trigger Action Scale to assess emotion-related impulsivity, the interview-based Modified Overt Aggression Scale and the self-rated Buss Perry Aggression Questionnaire']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",235.0,0.0388093,"Attrition, as with other online programs, was high; however, treatment completers reported high satisfaction, and outcomes changed more rapidly during treatment than waitlist across all key outcome indices.","[{'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of California Berkeley, USA. Electronic address: sljohnson@berkeley.edu.'}, {'ForeName': 'Mackenzie Rae', 'Initials': 'MR', 'LastName': 'Zisser', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Devon B', 'Initials': 'DB', 'LastName': 'Sandel', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Swerdlow', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Carver', 'Affiliation': 'University of Miami, USA.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Sanchez', 'Affiliation': 'University of California Berkeley, USA.'}, {'ForeName': 'Ephrem', 'Initials': 'E', 'LastName': 'Fernandez', 'Affiliation': 'University of Texas San Antonio, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103708']
2173,32896933,Functional Near-Infrared Spectroscopy to Assess Central Pain Responses in a Nonpharmacologic Treatment Trial of Osteoarthritis.,"BACKGROUND AND PURPOSE


Knee osteoarthritis (OA) is a common source of pain in older adults. Although OA-induced pain can be relieved with analgesics and anti-inflammatory drugs, the current opioid epidemic is fostering the exploration of nonpharmacologic strategies for pain mitigation. Amongs these, transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM) hold potential for pain-relief efficacy due to their neuromodulatory effects of the central nervous system, which is known to play a fundamental role in pain perception and processing.
METHODS


In this double-blind study, we used functional near-infrared spectroscopy (fNIRS) to investigate the effects of tDCS combined with MBM on underlying pain processing mechanisms at the central nervous level in older adults with knee OA. Nineteen subjects were randomly assigned to two groups undergoing a 10-day active tDCS and MBM regimen and a sham tDCS and MBM regimen, respectively.
RESULTS


Our results showed that the neuromodulatory intervention significantly relieved pain only in the group receiving active treatment. We also found that only the active treatment group showed a significant increase in oxyhemoglobin activation of the superior motor and somatosensory cortices colocated to the placement of the tDCS anodal electrode. To our knowledge, this is the first study in which the combined effect of tDCS and MBM is investigated using fNIRS.
CONCLUSION


In conclusion, fNIRS can be effectively used to investigate neural mechanisms of pain at the cortical level in association with nonpharmacological, self-administered treatments.",2020,We also found that only the active treatment group showed a significant increase in oxyhemoglobin activation of the superior motor and somatosensory cortices colocated to the placement of the tDCS anodal electrode.,"['older adults', 'older adults with knee OA', 'Nineteen subjects']","['functional near-infrared spectroscopy (fNIRS', 'transcranial direct current stimulation (tDCS) and mindfulness-based meditation (MBM', 'neuromodulatory intervention', 'tDCS combined with MBM', '10-day active tDCS and MBM regimen and a sham tDCS and MBM']","['pain', 'oxyhemoglobin activation', 'Central Pain Responses']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0234243', 'cui_str': 'Central pain'}]",19.0,0.0361853,We also found that only the active treatment group showed a significant increase in oxyhemoglobin activation of the superior motor and somatosensory cortices colocated to the placement of the tDCS anodal electrode.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollonini', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montero-Hernandez', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Cizik School of Nursing, University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'School of Public Health, University of Texas Health Science Center, Houston, TX.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mathis', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, The University of Texas Health Science Center at Houston, Houston, TX.'}, {'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Cizik School of Nursing, University of Texas Health Science Center, Houston, TX.'}]",Journal of neuroimaging : official journal of the American Society of Neuroimaging,['10.1111/jon.12782']
2174,32896955,Efficacy of a complex smartphone application for reducing hazardous alcohol consumption: Study protocol for a randomized controlled trial with analysis of in-app user behavior in relation to outcome.,"OBJECTIVE


The efficacy of alcohol reduction applications is variable, and the underlying factors are largely unknown. The aim of this study is threefold: evaluate the relationship between user engagement and intervention efficacy, investigate the efficacy of the different functions applied, and investigate the efficacy of the intervention application compared to control groups.
METHODS


A randomized controlled trial will be conducted to determine the efficacy of a newly developed smartphone application compared to the controls in reducing alcohol consumption at a 30, 60, 90, 120, 150, and 180 days follow-up. Hazardous drinkers, aged 18 years or older, will be recruited through web articles and will be randomized (blinded to their allocation), to receive one of the two versions of the application (educational or control application) for 30 days, or will be allocated to a wait-list control group. Function usage times will be recorded on a single-user level to determine the association between application usage and efficacy.
RESULTS


Data collection will be completed by July 2020, and follow-up will be completed by January 2021.
CONCLUSIONS


The evaluation of intervention efficacy as a function of user behavior will hopefully contribute to the science of developing more efficient alcohol intervention applications in the future.",2020,The evaluation of intervention efficacy as a function of user behavior will hopefully contribute to the science of developing more efficient alcohol intervention applications in the future.,"['Hazardous drinkers, aged 18 years or older']","['complex smartphone application', 'application (educational or control application']","['alcohol consumption', 'hazardous alcohol consumption']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0449879,The evaluation of intervention efficacy as a function of user behavior will hopefully contribute to the science of developing more efficient alcohol intervention applications in the future.,"[{'ForeName': 'Domonkos', 'Initials': 'D', 'LastName': 'File', 'Affiliation': 'Institute of Psychology, Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Beáta', 'Initials': 'B', 'LastName': 'Bőthe', 'Affiliation': 'Institute of Psychology, Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Máté', 'Initials': 'M', 'LastName': 'Kapitány-Fövény', 'Affiliation': 'Department of Addiction, Semmelweis University Faculty of Health Sciences, Budapest, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Demetrovics', 'Affiliation': 'Institute of Psychology, Eötvös Loránd University, Budapest, Hungary.'}]",International journal of methods in psychiatric research,['10.1002/mpr.1848']
2175,32896992,Weekly split-dose regimen for oral methotrexate reduced polyglutamation in red blood cells in patients with rheumatoid arthritis compared with single-dose regimen: Results from a multicentered randomized control trial.,"AIMS


We compared the incidence of adverse events between single and divided-dose regimens of methotrexate (MTX) by using a multicenter randomized controlled trial.
METHODS


Eighty-nine patients with insufficient control on MTX 8 mg/wk were randomly assigned into single-dose (39 patients) or triple dose (39 patients) groups. The MTX dose for all patients was gradually increased to 16 mg/wk. The primary endpoint was the occurrence of liver dysfunction during the observation period (20 weeks).
RESULTS


There were no differences in baseline data and MTX dose at Week 20 between groups. There was no significant difference in the incidence of liver dysfunction between groups (single dose, 3 [7.7%] patients vs. triple dose, 5 [13.2%] patients; P = .455). The incidence of adverse event increased in triple dose (single dose, 12 [30.8%] patients vs. triple dose, 20 [51.3%]), but the difference was not significant (P = .066). There was no significant difference in disease activity between groups, although MTX-triglutamate (PG3), MTX-PG4, and MTX-PG5 were significantly higher in the single dose group.
CONCLUSIONS


Weekly split dosing reduced the polyglutamation of MTX. There was no significant difference in efficacy and safety between the 2 groups.",2020,"There was no significant difference in disease activity between groups, although MTX-triglutamate (PG3), MTX-PG4, and MTX-PG5 were significantly higher in the single dose group.
","['Eighty-nine patients with insufficient control on MTX 8\xa0mg/wk', 'patients with rheumatoid arthritis']","['methotrexate', 'MTX', 'methotrexate (MTX']","['disease activity', 'incidence of adverse event', 'polyglutamation of MTX', 'MTX-triglutamate (PG3), MTX-PG4, and MTX-PG5', 'efficacy and safety', 'adverse events', 'red blood cells', 'occurrence of liver dysfunction', 'incidence of liver dysfunction']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0752458', 'cui_str': 'methotrexate triglutamate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}]",89.0,0.0892354,"There was no significant difference in disease activity between groups, although MTX-triglutamate (PG3), MTX-PG4, and MTX-PG5 were significantly higher in the single dose group.
","[{'ForeName': 'Shouhei', 'Initials': 'S', 'LastName': 'Nagaoka', 'Affiliation': 'Yokohama Minami Kyosai Hospital, Yokohama city, Kanagawa, Japan.'}, {'ForeName': 'Kou', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': 'Katayama Orthopedic Rheumatology Clinic, Asahikawa city, Hokkaido, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kasama', 'Affiliation': 'Showa University Koto-Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Ohashi Tani Orthopedics, Gifu city, Gifu, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Yokohama City University Medical Center, Yokohama city, Kanagawa, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Amasaki', 'Affiliation': 'KKR Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kataoka', 'Affiliation': 'Sapporo City General Hospital, Hokkaido, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Furusaki', 'Affiliation': 'KKR Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Kon', 'Affiliation': 'Katayama Orthopedic Rheumatology Clinic, Asahikawa city, Hokkaido, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Okamoto', 'Affiliation': 'AYUMI Pharmaceutical Corporation, Tokyo, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Sasano', 'Affiliation': 'AYUMI Pharmaceutical Corporation, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sagawa', 'Affiliation': 'Sagawa Akira Rheumatology Clinic, Sapporo city, Hokkaido, Japan.'}]",International journal of rheumatic diseases,['10.1111/1756-185X.13931']
2176,32897010,[The effectiveness of recombinant interferon alpha-2b in the treatment of chronic recurrent bacterial prostatitis].,"INTRODUCTION


Chronic recurrent bacterial prostatitis (HRBP) affects the reproductive function and negatively affects the quality of life of men. The multifactorial pathogenesis of this disease causes the failure of antibiotic therapy and some cases, requires an in-depth study of the mechanisms of disease development and additional treatment methods.
OBJECTIVES


of the study: to study of the effectiveness of immunoactive therapy (recombinant interferon alpha-2b with an antioxidant complex) in combination with antibacterial therapy in patients with HRBP.
MATERIALS AND METHODS


Prospective trial: examination and treatment of 62 patients. Two groups: I (study) group (n=31) received antibacterial therapy (ABT) and a therapy with recombinant IFN Alpha-2b based medication with antioxidant complex (vitamins E and C), II (control) group (n=31) received only ABT. The examination plan included questionnaires (NIH - CPSI, IPSS, Hamilton), general blood and urine tests, biochemical blood tests, urethral scrapings for PCR diagnostics, plasma testosterone, native, electron microscopy, culture test and immunoferment analysis of the prostate sercet, uroflowmetry, Transrectal ultrasonography (TRUS).
RESULTS


When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.",2020,"When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.","['Chronic recurrent bacterial prostatitis (HRBP', 'patients with HRBP', '62 patients', 'chronic recurrent bacterial prostatitis']","['immunoactive therapy (recombinant interferon alpha-2b with an antioxidant complex', 'antibacterial therapy (ABT) and a therapy with recombinant IFN Alpha-2b based medication with antioxidant complex (vitamins E and C), II (control) group (n=31) received only ABT', 'recombinant interferon alpha-2b']","['questionnaires (NIH - CPSI, IPSS, Hamilton), general blood and urine tests, biochemical blood tests, urethral scrapings for PCR diagnostics, plasma testosterone, native, electron microscopy, culture test and immunoferment analysis of the prostate sercet, uroflowmetry, Transrectal ultrasonography (TRUS']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0748023', 'cui_str': 'Bacterial prostatitis'}, {'cui': 'C0062748', 'cui_str': 'histidine rich basic peptide (Aplysia)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0041967', 'cui_str': 'Urethral'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0857717', 'cui_str': 'Plasma testosterone'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}]",62.0,0.038075,"When monitoring the clinical picture according to questionnaires (IPSS, NIH-CPSI, Hamilton scale) and laboratory indicators, 1 month after treatment, a significant reduction in symptoms was observed in both groups, and after 3, 6, and 12 months - in patients of group I.
CONCLUSIONS


The Combination of an antibacterial drug and recombinant interferon alpha-2b in the treatment of HRBP provides more effective relief of the infectious and inflammatory process in the long term than antibacterial monotherapy.","[{'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Ibishev', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mantsov', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Krainii', 'Affiliation': 'Department of Urology and Human Reproductive Health, Rostov State Medical University, Ministry of Health of Russia, Rostov-on-don, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2177,32897013,"[An influence of herbal plant based on the combination of natural terpenes, vitamin and essential oil on the spontaneous stone passage after extracorporeal shock-wave lithotripsy].","INTRODUCTION


There are more than 20 drugs, that are widely used as medical expulsive therapy after extracorporeal shock wave lithotripsy (ESWL). Herbal plants are actively used along with the drug therapy in order to improve the efficiency of the treatment.
PURPOSE OF THE STUDY


to evaluate the efficiency of the drug ""Renotinex"" in patients with kidney stones, as medical expulsive therapy.
MATERIALS AND METHODS


A total of 41 patients with kidney stones who undergone ESWL were included in the study. Patients were divided into two groups of 21 patients. In the main group, patients received the dietary supplement ""Renotinex"" 2 capsules 2 times a day for 1 month, along with standard medical expulsive therapy (NSAIDs [Diclofenac suppositories 50 mg in case of pain] + alpha blockers [Tamsulosin 0.4 mg in the morning for 1 month). The efficiency of treatment was evaluated after 2 and 4 weeks by means of ultrasound and x-ray. A presence and mean size of the stone and dilatation of the collecting system were assessed. In addition, complete blood count (hemoglobin, level of red blood cells and white blood cells), as well as urinalysis (microhematuria and leukocyturia) were performed. For statistical analysis, Student's criterion and the Fishers method were used.
RESULTS


After 2 weeks of treatment, a decrease in the hemoglobin level, number of leukocytes and erythrocytes in urine, as well as a significant decrease in pelvis size and the average size of the urinary stone were seen in the main group. In the control group, there was also a slight decrease in the hemoglobin and a significant increase in the grade of leukocyturia and microhematuria. After 4 weeks, significant intergroup differences were documented in the level of microhematuria, pelvis size and the presence of stone in the collecting system, as confirmed by ultrasound and X-ray study. Stone-free rate in the main group was 47.6%, compared to 20% in the control group.
CONCLUSION


Medical expulsive therapy in combination with dietary supplements ""Renotinex"" after ESWL is more efficient than standard medical expulsive therapy (NSAIDs and -blockers) as monotherapy.",2020,"After 2 weeks of treatment, a decrease in the hemoglobin level, number of leukocytes and erythrocytes in urine, as well as a significant decrease in pelvis size and the average size of the urinary stone were seen in the main group.","['patients with kidney stones, as medical expulsive therapy', '41 patients with kidney stones who undergone ESWL were included in the study']","['natural terpenes, vitamin and essential oil', 'herbal plant', 'extracorporeal shock-wave lithotripsy', 'standard medical expulsive therapy (NSAIDs [Diclofenac suppositories 50 mg in case of pain] + alpha blockers [Tamsulosin']","['spontaneous stone passage', 'hemoglobin level, number of leukocytes and erythrocytes in urine', 'Stone-free rate', 'complete blood count (hemoglobin, level of red blood cells and white blood cells), as well as urinalysis (microhematuria and leukocyturia', 'level of microhematuria, pelvis size and the presence of stone in the collecting system', 'hemoglobin', 'grade of leukocyturia and microhematuria', 'pelvis size and the average size of the urinary stone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0039561', 'cui_str': 'Terpene'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0015359', 'cui_str': 'Extracorporeal shockwave lithotripsy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001641', 'cui_str': 'Alpha adrenergic receptor antagonist'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0239937', 'cui_str': 'Microscopic hematuria'}, {'cui': 'C0555120', 'cui_str': 'Urine micr.:leukocytes present'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}]",41.0,0.0185394,"After 2 weeks of treatment, a decrease in the hemoglobin level, number of leukocytes and erythrocytes in urine, as well as a significant decrease in pelvis size and the average size of the urinary stone were seen in the main group.","[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Prosyannikov', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Zolotuhin', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'Yu Yu', 'Initials': 'YY', 'LastName': 'Madykin', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Konstantinova', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Voytko', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Anokhin', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Sivkov', 'Affiliation': 'Department of urolithiasis of N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2178,32897014,[Influence of phenazopyridine on the well-being of patients during and after cystoscopy].,"INTRODUCTION


Cystoscopy is one of the most common procedures in urology. There is no single approach to pain relief. In the literature, there are conflicting data on the efficiency of intra-urethral gels. The use of non-steroidal anti-inflammatory drugs, intravenous sedation, and nitric oxide analgesia has been described. Phenazopyridine has been known for a long time. Acting on the bladder mucosa, it has a local analgesic effect. AN evaluation of phenazopyridine intake prior to cystoscopy in order to decrease pain during procedure and facilitate subsequent urination was performed.
MATERIALS AND METHODS


A total of 97 patients were included in the study. Indications for cystoscopy were as following: hematuria, lower urinary tract symptoms/pain, a need to remove ureteral stent. The patients were randomized into two groups. In the main group (n=50), phenazopyridine 200 mg was administered 20 minutes before cystoscopy and then at a dose of 200 mg every 8 hours (in total three doses) in combination with lidocaine gel. In the control group (n=47), only lidocaine gel was used. Heart rate was measured before and after the procedure. All patients were asked to complete a visual analogue scale (VAS) 3, 8 and 24 hours after cystoscopy with the assessment of the first urination.
RESULTS


After cystoscopy, the difference between groups in VAS score was 27.7% in favor of the main group (p<0.001). After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005. The heart rate after the procedure in the main group was 75.1 beats/min, compared to 77.9 beats/min in the control group (p=0.016).
CONCLUSION


The intake of phenazopyridine allows to reduce pain intensity during and after cystoscopy and alleviate pain during first urination.",2020,"After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005.","['patients during and after cystoscopy', 'A total of 97 patients were included in the study']","['lidocaine gel', 'Phenazopyridine', 'phenazopyridine', 'phenazopyridine intake prior to cystoscopy']","['visual analogue scale (VAS', 'proportion of ""zero"" results', 'VAS score', 'pain relief', 'pain intensity', 'Heart rate', 'heart rate', 'average score', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0031379', 'cui_str': 'Phenazopyridine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",97.0,0.0328551,"After 3 hours, the average score in the main group was two times less than in the Control (p=0.012), while 3 and 8 hours after cystoscopy, the proportion of ""zero"" results was 10% and 0%, 28% and 4%, respectively, p<0.005.","[{'ForeName': 'A Yu', 'Initials': 'AY', 'LastName': 'Tsukanov', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Makushin', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mirzakadiev', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Zolotov', 'Affiliation': 'Department of Surgical diseases and Urology of Postgraduate Education FGBOU VO Omsk State Medical University of the Ministry of Health of Russian Federation, Omsk, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2179,32897015,[Possibilities of using dietary supplements with antioxidant properties in urinary stone disease].,"INTRODUCTION


Dietary supplements are successfully used in many fields of medicine, including urology. In particular, urologists often prescribe dietary supplements for patients with urolithiasis.
AIM


to study an influence of dietary supplements Nefradoz on the metabolism of the main stone-forming substances and inhibitors of stone formation in patients with urolithiasis.
INTRODUCTION


Dietary supplements are successfully used in many fields of medicine, including urology. In particular, urologists often prescribe dietary supplements for patients with urolithiasis.
AIM


to study an influence of dietary supplements Nefradoz on the metabolism of the main stone-forming substances and inhibitors of stone formation in patients with urolithiasis.
MATERIALS AND METHODS


A total of 60 patients with urinary stone diseases were included in a single-center prospective randomized study. All patients were divided into 2 groups of 30 people, depending on the treatment. In the main group, patients followed standard diet, received general recommendations and dietary supplements Nefradoz for 28-30 days, 1 capsule (150 mg) 2 times a day with meals. In the control group, patients received only general recommendations and followed standard diet therapy for 28-30 days. The blood biochemical profile and 24-hour urine analysis were evaluated, as well as a urinalysis was performed on daily basis.
RESULTS


In patients receiving Nefradoz, urinary uric acid excretion increased by 0.9 mmol/day. It must be emphasized that an increase in uric acid excretion did not exceed the upper normal limit. A tendency towards an increase in urine excretion of sodium (by 54 mmol / day), magnesium (by 1 mmol / day) and citrates (by 0.6 mmol / day) was also found. The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group. Higher urine pH in the main group compared to the control group was also shown. The severity of hematuria with the use of Nefradoz was almost two times lower than in patients who did not receive dietary supplement.
CONCLUSION


Considering our data on the ability of dietary supplement Nefradoz to increase the concentration of main inhibitors of stone formation (magnesium and citrates), Nefradoz can be recommended for patients with urinary stone diseases, especially with concomitant hypomagnesuria and hypocitraturia.",2020,"The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group.","['patients with urolithiasis', '60 patients with urinary stone diseases', 'patients with urinary stone diseases', 'urinary stone disease']","['dietary supplements', 'dietary supplements Nefradoz', 'general recommendations and dietary supplements Nefradoz', 'only general recommendations and followed standard diet therapy']","['blood biochemical profile and 24-hour urine analysis', 'urine excretion of sodium', 'urinary uric acid excretion', 'urine specific gravity', 'Higher urine pH', 'uric acid excretion', 'severity of hematuria with the use of Nefradoz']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0042018', 'cui_str': 'Urolith'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0202517', 'cui_str': 'Urinalysis, specific gravity measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0042044', 'cui_str': 'Urine pH test'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",60.0,0.0403146,"The analysis of urinalysis showed that in the main group, urine specific gravity was lower than in the control group.","[{'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Prosiannikov', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Konstantinova', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Golovanov', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Anokhin', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Voitko', 'Affiliation': 'N.A. Lopatkin Scientific Research Institute of Urology and Interventional Radiology Branch of the National Medical Research Centre of Radiology of the Ministry of Health of Russian Federation, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[]
2180,32897034,Phase 2 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis.,"BACKGROUND


Patients with bronchiectasis have frequent exacerbations that are thought to be related to neutrophilic inflammation. The activity and quantity of neutrophil serine proteases, including neutrophil elastase, are increased in the sputum of patients with bronchiectasis at baseline and increase further during exacerbations. Brensocatib (INS1007) is an oral reversible inhibitor of dipeptidyl peptidase 1 (DPP-1), an enzyme responsible for the activation of neutrophil serine proteases.
METHODS


In a phase 2, randomized, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1:1 ratio, patients with bronchiectasis who had had at least two exacerbations in the previous year to receive placebo, 10 mg of brensocatib, or 25 mg of brensocatib once daily for 24 weeks. The time to the first exacerbation (primary end point), the rate of exacerbations (secondary end point), sputum neutrophil elastase activity, and safety were assessed.
RESULTS


Of 256 patients, 87 were assigned to receive placebo, 82 to receive 10 mg of brensocatib, and 87 to receive 25 mg of brensocatib. The 25th percentile of the time to the first exacerbation was 67 days in the placebo group, 134 days in the 10-mg brensocatib group, and 96 days in the 25-mg brensocatib group. Brensocatib treatment prolonged the time to the first exacerbation as compared with placebo (P = 0.03 for 10-mg brensocatib vs. placebo; P = 0.04 for 25-mg brensocatib vs. placebo). The adjusted hazard ratio for exacerbation in the comparison of brensocatib with placebo was 0.58 (95% confidence interval [CI], 0.35 to 0.95) in the 10-mg group (P = 0.03) and 0.62 (95% CI, 0.38 to 0.99) in the 25-mg group (P = 0.046). The incidence-rate ratio was 0.64 (95% CI, 0.42 to 0.98) in the 10-mg group, as compared with placebo (P = 0.04), and 0.75 (95% CI, 0.50 to 1.13) in the 25-mg group, as compared with placebo (P = 0.17). With both brensocatib doses, sputum neutrophil elastase activity was reduced from baseline over the 24-week treatment period. The incidence of dental and skin adverse events of special interest was higher with the 10-mg and 25-mg brensocatib doses, respectively, than with placebo.
CONCLUSIONS


In this 24-week trial, reduction of neutrophil serine protease activity with brensocatib in patients with bronchiectasis was associated with improvements in bronchiectasis clinical outcomes. (Funded by Insmed; WILLOW ClinicalTrials.gov number, NCT03218917.).",2020,Brensocatib treatment prolonged the time to the first exacerbation as compared with placebo (P = 0.03 for 10-mg brensocatib vs. placebo; P = 0.04 for 25-mg brensocatib vs. placebo).,"['256 patients', 'patients with bronchiectasis', 'once daily for 24 weeks', 'patients with bronchiectasis who had had at least two exacerbations in the previous year to receive', 'Bronchiectasis']","['Brensocatib (INS1007', 'placebo', 'placebo, 10 mg of brensocatib, or 25 mg of brensocatib', 'placebo, 82 to receive 10 mg of brensocatib, and 87 to receive 25 mg of brensocatib']","['adjusted hazard ratio for exacerbation', 'incidence of dental and skin adverse events of special interest', 'activity and quantity of neutrophil serine proteases, including neutrophil elastase', 'incidence-rate ratio', 'rate of exacerbations (secondary end point), sputum neutrophil elastase activity, and safety', 'sputum neutrophil elastase activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0036734', 'cui_str': 'Serine Endopeptidases'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",256.0,0.548532,Brensocatib treatment prolonged the time to the first exacerbation as compared with placebo (P = 0.03 for 10-mg brensocatib vs. placebo; P = 0.04 for 25-mg brensocatib vs. placebo).,"[{'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Haworth', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Metersky', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Loebinger', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sibila', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': ""O'Donnell"", 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Sullivan', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Mange', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Daley', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021713']
2181,32897035,Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis.,"BACKGROUND


Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare disease characterized by progressive surfactant accumulation and hypoxemia. It is caused by disruption of granulocyte-macrophage colony-stimulating factor (GM-CSF) signaling, which pulmonary alveolar macrophages require to clear surfactant. Recently, inhaled GM-CSF was shown to improve the partial pressure of arterial oxygen in patients with aPAP.
METHODS


In a double-blind, placebo-controlled, three-group trial, we randomly assigned patients with aPAP to receive the recombinant GM-CSF molgramostim (300 μg once daily by inhalation), either continuously or intermittently (every other week), or matching placebo. The 24-week intervention period was followed by an open-label treatment-extension period. The primary end point was the change from baseline in the alveolar-arterial difference in oxygen concentration (A-aDo 2 ) at week 24.
RESULTS


In total, 138 patients underwent randomization; 46 were assigned to receive continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo. Invalid A-aDo 2  data for 4 patients (1 in each molgramostim group and 2 in the placebo group) who received nasal oxygen therapy during arterial blood gas measurement were replaced by means of imputation. For the primary end point - the change from baseline in the A-aDo 2  at week 24 - improvement was greater among patients receiving continuous molgramostim than among those receiving placebo (-12.8 mm Hg vs. -6.6 mm Hg; estimated treatment difference, -6.2 mm Hg; P = 0.03 by comparison of least-squares means). Patients receiving continuous molgramostim also had greater improvement than those receiving placebo for secondary end points, including the change from baseline in the St. George's Respiratory Questionnaire total score at week 24 (-12.4 points vs. -5.1 points; estimated treatment difference, -7.4 points; P = 0.01 by comparison of least-squares means). For multiple end points, improvement was greater with continuous molgramostim than with intermittent molgramostim. The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
CONCLUSIONS


In patients with aPAP, daily administration of inhaled molgramostim resulted in greater improvements in pulmonary gas transfer and functional health status than placebo, with similar rates of adverse events. (Funded by Savara Pharmaceuticals; IMPALA ClinicalTrials.gov number, NCT02702180.).",2020,"The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
","['Autoimmune Pulmonary Alveolar Proteinosis', 'patients with aPAP', '4 patients (1 in each molgramostim group and 2 in the placebo group) who received', '138 patients underwent randomization; 46 were assigned to receive']","['nasal oxygen therapy', 'Inhaled Molgramostim Therapy', 'placebo', 'continuous molgramostim, 45 to receive intermittent molgramostim, and 47 to receive placebo', 'inhaled molgramostim', 'recombinant GM-CSF molgramostim']","['alveolar-arterial difference in oxygen concentration', 'partial pressure of arterial oxygen', 'pulmonary gas transfer and functional health status', 'adverse events', 'adverse events and serious adverse events', ""St. George's Respiratory Questionnaire total score""]","[{'cui': 'C1970472', 'cui_str': 'Autoimmune pulmonary alveolar proteinosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0218633', 'cui_str': 'molgramostim'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0428646', 'cui_str': 'Oxygen concentration'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",138.0,0.336607,"The percentages of patients with adverse events and serious adverse events were similar in the three groups, except for the percentage of patients with chest pain, which was higher in the continuous-molgramostim group.
","[{'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Trapnell', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bonella', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Morgan', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bendstrup', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Campo', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Spyros A', 'Initials': 'SA', 'LastName': 'Papiris', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Yamaguchi', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Cetinkaya', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Mikhail M', 'Initials': 'MM', 'LastName': 'Ilkovich', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Mordechai R', 'Initials': 'MR', 'LastName': 'Kramer', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Veltkamp', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Baba', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Ganslandt', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Tarnow', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Waterer', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': 'Taneli', 'Initials': 'T', 'LastName': 'Jouhikainen', 'Affiliation': 'From the Translational Pulmonary Science Center, Cincinnati Children\'s Hospital Medical Center, Cincinnati (B.C.T.); National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka (Y.I.), Aichi Medical University Hospital, Nagakute, Aichi (E.Y.), and Kanagawa Cardiovascular and Respiratory Center, Yokohama (T.B.) - all in Japan; Outpatients Clinic for Interstitial and Rare Lung Disease, Ruhrlandklinik University Hospital, Essen (F.B.), and Center for Interstitial and Rare Lung Diseases, Pulmonology, Thoraxklinik, Heidelberg University Hospital, and German Center for Lung Research, Heidelberg (M.K.) - all in Germany; the Departments of Critical Care and Respiratory Medicine, Royal Brompton Hospital, London (C.M.); Respiratory Diseases Department, Pontchaillou Hospital, IRSET UMR 1085, Rennes 1 University, Rennes, France (S.J.); the Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus (E.B.), and Savara, Horsholm (C.G., I.T.) - both in Denmark; the Pneumology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy (I.C.); the 2nd Pulmonary Medicine Department, General University Hospital ""Attikon,"" Medical School, National and Kapodistrian University of Athens, Athens (S.A.P.); University of Health Sciences Turkey, Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital, Istanbul (E.C.); Pulmonary Clinic of St. Petersburg Pavlov State Medical University, St. Petersburg, Russia (M.M.I.); Institute of Pulmonary and Allergy Medicine, Rabin Medical Center, Petah Tikva, Israel (M.R.K.); ILD Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands (M.V.); the University of Western Australia, Royal Perth Hospital, Perth, Australia (G.W.); and Savara, Austin, TX (T.J.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913590']
2182,32897117,Re: Effect of Intensive vs Standard Blood Pressure Treatment upon Erectile Function in Hypertensive Men: Findings from the Systolic Blood Pressure Intervention Trial.,,2020,,['Hypertensive Men'],['Intensive vs Standard Blood Pressure Treatment'],[],"[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0373286,,"[{'ForeName': 'Allen D', 'Initials': 'AD', 'LastName': 'Seftel', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001252.03']
2183,32897125,Re: Effect on Patient Safety of a Resident Physician Schedule without 24-Hour Shifts.,,2020,,[],['Resident Physician Schedule without 24-Hour Shifts'],[],[],"[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0333051', 'cui_str': 'Shift'}]",[],,0.0332029,,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Resnick', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001256.01']
2184,32897130,Small Randomized Controlled Trial of the New Passport to Wellness HIV Prevention Intervention for Black Men Who Have Sex With Men (BMSM).,"We developed and tested Passport to Wellness (PtW), a client-centered intervention to improve engagement in HIV/STI prevention and services to improve social determinants of health among Black men who have sex with men (BMSM) using incentives and peer support. We assessed PtW's impact on HIV/STI screening and pre/post-exposure prophylaxis (PrEP/PEP) knowledge/uptake using a randomized trial that compared the full intervention to one lacking peer support. We compared changes within groups surveyed at baseline and 6 months. We enrolled 80 eligible BMSM, among 399 screened. Among retained participants (34 peer-supported; 27 comparison), overall increases were observed in HIV (30% to 87%;  p  < .001) and STI (28% to 80%;  p  < .001) testing within the prior 6 months, as well as in PrEP and PEP awareness, and PrEP use. Statistically significant between group differences were not observed. Tailored prevention planning, incentives, and addressing social determinants may help move Black MSM along the HIV prevention continuum.",2020,Statistically significant between group differences were not observed.,"['Black Men', 'Black men who have sex with men (BMSM) using incentives and peer support', 'We enrolled 80 eligible BMSM, among 399 screened', 'Who Have Sex With Men']","['client-centered intervention to improve engagement in HIV/STI prevention and services', 'New Passport to Wellness HIV Prevention Intervention']",[],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],80.0,0.0493782,Statistically significant between group differences were not observed.,"[{'ForeName': 'Nina T', 'Initials': 'NT', 'LastName': 'Harawa', 'Affiliation': 'David Geffen School of Medicine at the University of California Los Angeles (UCLA), Los Angeles, California.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Schrode', 'Affiliation': 'College of Medicine, Charles R. Drew University of Medicine and Science, Los Angeles.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McWells', 'Affiliation': 'Los Angeles Centers for Alcohol and Drug Abuse.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Weiss', 'Affiliation': 'UCLA Fielding School of Public Health.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Hilliard', 'Affiliation': 'College of Medicine, Charles R. Drew University of Medicine and Science, Los Angeles.'}, {'ForeName': 'Ricky N', 'Initials': 'RN', 'LastName': 'Bluthenthal', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}]",AIDS education and prevention : official publication of the International Society for AIDS Education,['10.1521/aeap.2020.32.4.311']
2185,32897150,Re: Randomized Study of Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-Year Postbiopsy Follow-up.,,2020,,['Men on Active Surveillance (ASIST'],['Systematic Biopsy versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.0661264,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001261.02']
2186,32897182,Early Mobilization Versus Splinting After Surgical Management of Distal Radius Fractures.,"BACKGROUND


After the surgical management of distal radius fractures (DRF) in older patients, further treatment with a splint often follows. It is unclear whether early mobilization might be superior to splinting in this group of patients, as it is in others. In this prospective, randomized, controlled trial, we attempted to determine whether early mobilization yields better outcomes.
METHODS


50 patients over age 70 with DRF were included in the trial. Group A (the splint group) was treated with postoperative immobilization, group B with early mobilization. Clinical follow-up examinations were performed at 2, 6, and 12 weeks and at 6 and 12 months. X-rays were obtained preoperatively, postoperatively, at 6 weeks, and at 6 months. The primary outcome parameter was the modified Mayo Wrist Score (MMWS) at 6 weeks.
RESULTS


At 6 weeks, the functional outcome was better to a statistically significant extent in group B (MMWS; 65/100 vs. 55/100 [q25 : 55/40 - q75 : 70/70; p = 0.025]). No difference between the two groups was demonstrable in their further clinical course. The estimated regression model revealed a statistically significant effect of the method of treatment (p = 0.023). There were no differences in hand strength or in x-ray findings.
DISCUSION


Early mobilization is associated with better wrist function on initial follow-up, without any demonstrable disadvantage with respect to secondary dislocation. The psychological benefit and protective function of wrist splinting in patients who are in danger of falling should nonetheless be investigated in further studies.",2020,"There were no differences in hand strength or in x-ray findings.
","['Distal Radius Fractures', 'older patients', '50 patients over age 70 with DRF were included in the trial']","['postoperative immobilization, group B with early mobilization', 'Early Mobilization Versus Splinting']","['hand strength', 'functional outcome', 'modified Mayo Wrist Score (MMWS']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0204861', 'cui_str': 'Application of splint'}]","[{'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0354781,"There were no differences in hand strength or in x-ray findings.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zeckey', 'Affiliation': 'Department of Trauma and Reconstructive Surgery, University Hospital Munich, Ludwig-Maximilians-Universität München; Department of Trauma Surgery and Orthopedics, RoMed Klinikum Rosenheim; Statistical Consulting Unit StaBLab, Department of Statistics, Ludwig-Maximilians-Universität München.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Späth', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kieslich', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kammerlander', 'Affiliation': ''}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Böcker', 'Affiliation': ''}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Weigert', 'Affiliation': ''}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Neuerburg', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0445']
2187,32897208,[Ultrasound subgingival scaling combined with manual root planing for treatment of chronic periodontitis in elderly patients].,"OBJECTIVE


To evaluate the clinical efficacy of ultrasound subgingival scaling combined with manual root planing for treatment of chronic periodontitis in elderly patients.
METHODS


Forty elderly patients with chronic periodontitis were randomly divided into test group for treatment with ultrasound and Gracey subgingival curette for subgingival scaling combined with manual root planing and control group treated with ultrasound subgingival curette scaling ( n =20). We compared plaque index (PLI), bleeding index (BI), probing depth (PD), and attachment loss (AL) between the two groups before and at 6 weeks and 12 weeks after the treatment.
RESULTS


After periodontal treatment, PLI, BI, PD and AL all decreased significantly in both groups compared with the levels before the treatment ( P  &lt; 0.05). The patients in the test group showed significantly more obvious decrease of PD and AL than those in the control group ( P  &lt; 0.05), but the reduction of PLI and BI was comparable between the two groups ( P &gt;0.05).
CONCLUSIONS


Ultrasound subgingival scaling combined with manual root planing produces better therapeutic effect than ultrasonic subgingival scaling alone for treatment of chronic periodontitis in elderly patients.",2020,"After periodontal treatment, PLI, BI, PD and AL all decreased significantly in both groups compared with the levels before the treatment ( P  &lt; 0.05).","['Forty elderly patients with chronic periodontitis', 'chronic periodontitis in elderly patients']","['ultrasound and Gracey subgingival curette for subgingival scaling combined with manual root planing and control group treated with ultrasound subgingival curette scaling', 'ultrasound subgingival scaling combined with manual root planing', 'ultrasonic subgingival scaling alone', 'Ultrasound subgingival scaling combined with manual root planing']","['plaque index (PLI), bleeding index (BI), probing depth (PD), and attachment loss (AL', 'PD and AL', 'reduction of PLI and BI', 'PLI, BI, PD and AL']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",40.0,0.0189145,"After periodontal treatment, PLI, BI, PD and AL all decreased significantly in both groups compared with the levels before the treatment ( P  &lt; 0.05).","[{'ForeName': 'Wenyan', 'Initials': 'W', 'LastName': 'Huo', 'Affiliation': ""Department of Stomatology, Beijing Bo'ai Hospital//China Rehabilitation Research Center//Capital Medical University School of Rehabilitation Medicine, Beijing 100068, China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Stomatology, Beijing Bo'ai Hospital//China Rehabilitation Research Center//Capital Medical University School of Rehabilitation Medicine, Beijing 100068, China.""}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Stomatology, Beijing Bo'ai Hospital//China Rehabilitation Research Center//Capital Medical University School of Rehabilitation Medicine, Beijing 100068, China.""}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Stomatology, Beijing Bo'ai Hospital//China Rehabilitation Research Center//Capital Medical University School of Rehabilitation Medicine, Beijing 100068, China.""}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.05.18']
2188,32897234,"Evaluation of a Package of Behaviour Change Interventions (Baduta Program) to Improve Maternal and Child Nutrition in East Java, Indonesia: Protocol for an Impact Study.","BACKGROUND


Over the past decade, the prevalence of stunting has been close to 37% in children aged <5 years in Indonesia. The Baduta program, a multicomponent package of interventions developed by the Global Alliance for Improved Nutrition, aims to improve maternal and infant nutrition in Indonesia.
OBJECTIVE


This study aims to assess the impact of the Baduta program, a package of health system strengthening and behavior change interventions, compared with the standard village health services on maternal and child nutrition.
METHODS


The impact evaluation uses a cluster randomized controlled trial design with 2 outcome assessments. The first uses cross-sectional surveys of mothers of children aged 0-23 months and pregnant women before and after the interventions. The second is a cohort study of pregnant women followed until their child is 18 months from a subset of clusters. We will also conduct a process evaluation guided by the program impact pathway to assess coverage, fidelity, and acceptance. The study will be conducted in the Malang and Sidoarjo districts of East Java, Indonesia. The unit of randomization is the subdistricts. As random allocation of interventions to only 6 subdistricts is feasible, we will use constrained randomization to ensure balance of baseline covariates. The first intervention will be health system strengthening, including the Baby-Friendly Hospital Initiative, and training on counseling for appropriate infant and young child feeding (IYCF). The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices. The primary study outcome is child stunting (low length-for-age), and secondary outcomes include length-for-age Z scores, wasting (low weight-for-length), anemia, child morbidity, IYCF indicators, and maternal and child nutrient intakes. The sample size for each cross-sectional survey is 1400 mothers and their children aged <2 years and 200 pregnant women in each treatment group. The cohort evaluation requires a sample size of 340 mother-infant pairs in each treatment group. We will seek Gatekeeper consent and written informed consent from the participants. The intention-to-treat principle will guide our data analysis, and we will apply Consolidated Standards of Reporting Trials guidelines for clustered randomized trials in the analysis.
RESULTS


In February 2015, we conducted a baseline cross-sectional survey on 2435 women with children aged <2 years and 409 pregnant women. In February 2017, we conducted an end-line survey on 2740 mothers with children aged <2 years and 642 pregnant women. The cohort evaluation began in February 2015, with 729 pregnant women, and was completed in December 2016.
CONCLUSIONS


The results of the program evaluation will help guide policies to support effective packages of behavior change interventions to prevent child stunting in Indonesia.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR1-10.2196/18521.",2020,"The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices.","['729 pregnant women, and was completed in December 2016', '2435 women with children aged <2 years and 409 pregnant women', '1400 mothers and their children aged <2 years and 200 pregnant women in each treatment group', 'children aged <5 years in Indonesia', '340 mother-infant pairs in each treatment group', 'Malang and Sidoarjo districts of East Java, Indonesia', 'mothers of children aged 0-23 months and pregnant women before and after the interventions', '2740 mothers with children aged <2 years and 642 pregnant women', 'pregnant women followed until their child is 18 months from a subset of clusters']","['Baby-Friendly Hospital Initiative, and training on counseling for appropriate infant and young child feeding (IYCF', 'Package of Behaviour Change Interventions']","['child stunting (low length-for-age), and secondary outcomes include length-for-age Z scores, wasting (low weight-for-length), anemia, child morbidity, IYCF indicators, and maternal and child nutrient intakes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",2740.0,0.0950176,"The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices.","[{'ForeName': 'Michael John', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Australia.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Australia.'}, {'ForeName': 'Umi', 'Initials': 'U', 'LastName': 'Fahmida', 'Affiliation': 'SEAMEO RECFON-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Iwan', 'Initials': 'I', 'LastName': 'Ariawan', 'Affiliation': 'Center for Health Research, Faculty of Public Health, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Christiana Rialine', 'Initials': 'CR', 'LastName': 'Titaley', 'Affiliation': 'Faculty of Medicine, Pattimura University, Ambon City, Indonesia.'}, {'ForeName': 'Min Kyaw', 'Initials': 'MK', 'LastName': 'Htet', 'Affiliation': 'SEAMEO RECFON-Pusat Kajian Gizi Regional, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Damayanti', 'Affiliation': 'Center for Health Research, Faculty of Public Health, Universitas Indonesia, Jakarta, Indonesia.'}, {'ForeName': 'Mu', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Australia.'}, {'ForeName': 'Aang', 'Initials': 'A', 'LastName': 'Sutrisna', 'Affiliation': 'Indonesia Office, Global Alliance for Improved Nutrition, Jakarta, Indonesia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'Department of Population Health, London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.'}]",JMIR research protocols,['10.2196/18521']
2189,32897236,Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial.,"BACKGROUND


The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults.
OBJECTIVE


This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish.
METHODS


A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
RESULTS


The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023.
CONCLUSIONS


This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17840.",2020,"Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
","['older adults', 'adults aged 62 or older', 'younger individuals in the dental care of older adults', 'Older Adults', '22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants']","['silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish', '2 evidence-based nonsurgical strategies']","['caries lesion arrest, tooth sensitivity, and tooth pain', 'Oral Health Disparities']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.351444,"Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment.
","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Nelson', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Albert', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Milgrom', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States.'}]",JMIR research protocols,['10.2196/17840']
2190,32897310,Outcomes of Intensive Systolic Blood Pressure Reduction in Patients With Intracerebral Hemorrhage and Excessively High Initial Systolic Blood Pressure: Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


The safety and efficacy of intensive systolic blood pressure reduction in patients with intracerebral hemorrhage who present with systolic blood pressure greater than 220 mm Hg appears to be unknown.
Objective


To evaluate the differential outcomes of intensive (goal, 110-139 mm Hg) vs standard (goal, 140-179 mm Hg) systolic blood pressure reduction in patients with intracerebral hemorrhage and initial systolic blood pressure of 220 mm Hg or more vs less than 220 mm Hg.
Design, Setting, and Participants


This post hoc analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage-II trial was performed in November 2019 on data from the multicenter randomized clinical trial, which was conducted between May 2011 to September 2015. Patients with intracerebral hemorrhage and initial systolic blood pressure of 180 mm Hg or more, randomized within 4.5 hours after symptom onset, were included.
Interventions


Intravenous nicardipine infusion titrated to goals.
Main Outcomes and Measures


Neurological deterioration and hematoma expansion within 24 hours and death or severe disability at 90 days, plus kidney adverse events and serious adverse events until day 7 or hospital discharge.
Results


A total of 8532 patients were screened, and 999 individuals (mean [SD] age, 62.0 [13.1] years; 620 men [62.0%]) underwent randomization and had an initial SBP value. Among 228 participants with initial systolic blood pressures of 220 mm Hg or more, the rate of neurological deterioration within 24 hours was higher in those who underwent intensive (vs standard) systolic blood pressure reduction (15.5% vs 6.8%; relative risk, 2.28 [95% CI, 1.03-5.07]; P = .04). The rate of death and severe disability (39.0% vs 38.4%; relative risk, 1.02 [95% CI, 0.73-1.78]; P = .92) was not significantly different between the 2 groups. There was a significantly higher rate of kidney adverse events in participants randomized to intensive systolic blood pressure reduction (13.6% vs 4.2%; relative risk, 3.22 [95% CI, 1.21-8.56]; P = .01), but no difference was observed in the rate of kidney serious adverse events.
Conclusions and Relevance


The higher rate of neurological deterioration within 24 hours associated with intensive treatment in patients with intracerebral hemorrhage and initial systolic blood pressure of 220 mm Hg or more, without any benefit in reducing hematoma expansion at 24 hours or death or severe disability at 90 days, warrants caution against generalization of recommendations for intensive systolic blood pressure reduction.",2020,"There was a significantly higher rate of kidney adverse events in participants randomized to intensive systolic blood pressure reduction (13.6% vs 4.2%; relative risk, 3.22 [95% CI, 1.21-8.56]; P = .01), but no difference was observed in the rate of kidney serious adverse events.
","['Patients With Intracerebral Hemorrhage and Excessively High Initial Systolic Blood Pressure', 'Patients with intracerebral hemorrhage and initial systolic blood pressure of 180 mm Hg or more, randomized within 4.5 hours after symptom onset, were included', 'A total of 8532 patients were screened, and 999 individuals (mean [SD] age, 62.0 [13.1] years; 620 men [62.0%]) underwent randomization and had an initial SBP value', 'patients with intracerebral hemorrhage who present with systolic blood pressure greater than 220 mm Hg', 'patients with intracerebral hemorrhage and initial systolic blood pressure of 220 mm Hg or more vs less than 220 mm Hg.\nDesign, Setting, and Participants', 'Acute Cerebral Hemorrhage-II trial was performed in November 2019 on data from the multicenter randomized clinical trial, which was conducted between May 2011 to September 2015', '228 participants with']","['nicardipine', 'intensive systolic blood pressure reduction', 'Intensive Systolic Blood Pressure Reduction']","['systolic blood pressure reduction', 'rate of neurological deterioration', 'intensive systolic blood pressure reduction', 'initial systolic blood pressures', 'higher rate of neurological deterioration', 'rate of kidney serious adverse events', 'Measures\n\n\nNeurological deterioration and hematoma expansion within 24 hours and death or severe disability at 90 days, plus kidney adverse events and serious adverse events until day 7 or hospital discharge', 'rate of kidney adverse events', 'rate of death and severe disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4708788', 'cui_str': '620'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",8532.0,0.252734,"There was a significantly higher rate of kidney adverse events in participants randomized to intensive systolic blood pressure reduction (13.6% vs 4.2%; relative risk, 3.22 [95% CI, 1.21-8.56]; P = .01), but no difference was observed in the rate of kidney serious adverse events.
","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, University of Missouri, Columbia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenat Qureshi Stroke Institute, University of Missouri, Columbia.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenat Qureshi Stroke Institute, University of Missouri, Columbia.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Cheng-Li', 'Initials': 'CL', 'LastName': 'Lin', 'Affiliation': 'China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Steiner', 'Affiliation': 'Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, Germany.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Division of Neurosciences Critical Care, The Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.3075']
2191,32897319,"Feasibility and Acceptability of an Abbreviated, Four-Week Mindfulness Program for Chronic Pain Management.","OBJECTIVE


The Mindfulness-Based Stress Reduction program is effective at improving chronic pain outcomes, but the time demand hinders participation. This preliminary study evaluated the feasibility, acceptability, and potential effects of providing an abbreviated mindfulness program for patients with chronic pain.
DESIGN


A single-arm, mixed-methods, pre-post intervention study.
SETTING


An outpatient rehabilitation clinic at an academic medical center.
SUBJECTS


Participants were N = 23 adults with chronic pain who were new to mindfulness practice.
METHODS


Mindfulness-based Stress Reduction was adapted to shorten the program to four weekly 90-minute sessions and to focus content on pain management. Three cohorts of six to nine participants completed baseline and post-treatment measures of 1) patient-reported outcomes, including pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences.
RESULTS


Acceptable rates of retention and attendance and high ratings of satisfaction indicated that the intervention was feasible and acceptable. In interviews, participants found the program acceptable and beneficial and provided suggestions to improve it. From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
CONCLUSIONS


In adults with chronic pain, a four-week mindfulness program is feasible and acceptable, addresses the barrier of a lengthy program, and may improve quality of life and psychological functioning. An appropriately powered randomized controlled trial with a comparison group is needed to assess the intervention's effectiveness.",2020,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","['Participants were N = 23 adults with chronic pain who were new to mindfulness practice', 'Chronic Pain Management', 'adults with chronic pain', 'An outpatient rehabilitation clinic at an academic medical center', 'patients with chronic pain']","['abbreviated mindfulness program', 'Abbreviated, Four-Week Mindfulness Program', 'Mindfulness-Based Stress Reduction program']","['Feasibility and Acceptability', 'physical functioning and anxiety', 'quality of life and psychological functioning', 'pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences', 'retention and attendance and high ratings of satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",23.0,0.0312875,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","[{'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Brintz', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Keturah', 'Initials': 'K', 'LastName': 'Faurot', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gaylord', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa208']
2192,32897344,Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury.,"Importance


Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI.
Objective


To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI.
Design, Setting, and Participants


Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher.
Interventions


Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309).
Main Outcomes and Measures


The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events.
Results


Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, -0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, -2.9% [95% CI, -7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, -0.9 [95% CI, -2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, -5.4% [95% CI, -12.8% to 2.1%]; P = .16).
Conclusions and Relevance


Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended.
Trial Registration


ClinicalTrials.gov Identifier: NCT01990768.",2020,"The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%;","['patients with moderate or severe TBI', 'patients with TBI', 'Eligible participants (N\u2009=\u20091280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher', '1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants', 'Patients With Moderate or Severe Traumatic Brain Injury', '20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017', 'patients with moderate to severe TBI']","['Out-of-Hospital Tranexamic Acid vs Placebo', 'placebo', 'tranexamic acid', 'hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n\u2009=\u2009312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n\u2009=\u2009345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n\u2009=\u2009309']","['mean Glasgow Coma Scale score, 8', 'favorable neurologic function', '28-day mortality, 6-month Disability Rating Scale score (range, 0', '6-month Disability Rating Scale score', 'progression of intracranial hemorrhage', '28-day mortality', '6-month neurologic outcome', 'progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events', '6-Month Functional Neurologic Outcomes', 'neurologic outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517706', 'cui_str': '312'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4305168', 'cui_str': 'Disability Rating Scale score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",96.0,0.74178,"The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%;","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Eric N', 'Initials': 'EN', 'LastName': 'Meier', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McKnight', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Delores', 'Initials': 'D', 'LastName': 'Kannas', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Sheehan', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Bulger', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': ""Rescu, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Frascone', 'Affiliation': 'Department of Emergency Medicine, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Patrick L', 'Initials': 'PL', 'LastName': 'Bosarge', 'Affiliation': 'Department of Surgery, University of Alabama, Birmingham.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Johannigman', 'Affiliation': 'Department of Surgery, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Cotton', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Callum', 'Affiliation': 'Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'McMullan', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dries', 'Affiliation': 'Department of Surgery, Regions Hospital, St Paul, Minnesota.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tibbs', 'Affiliation': 'Trauma Surgery, Texas Health Presbyterian Hospital, Dallas.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Richmond', 'Affiliation': 'Department of Emergency Medicine, John Peter Smith Health Network, Ft Worth, Texas.'}, {'ForeName': 'Myron L', 'Initials': 'ML', 'LastName': 'Weisfeldt', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Tallon', 'Affiliation': 'Department of Emergency Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Garrett', 'Affiliation': 'Department of Emergency Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Zielinski', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Gandhi', 'Affiliation': 'Department of Surgery, John Peter Smith Health Network, Ft Worth, Texas.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Schlamp', 'Affiliation': 'British Columbia Emergency Health Services, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jui', 'Affiliation': 'Department of Emergency Medicine, Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Klein', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Rizoli', 'Affiliation': ""Department of Surgery, St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gamber', 'Affiliation': 'Department of Emergency Medicine, Medical City Plano, Plano, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fleming', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Vincent', 'Affiliation': 'Department of Surgery, McGovern Medical School, University of Texas Health Science Center, Houston.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Alabama, Birmingham.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Hendrickson', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Simonson', 'Affiliation': 'Emergency Medicine, Methodist Dallas Medical Center, Dallas, Texas.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Klotz', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Witham', 'Affiliation': 'Trauma Surgery, Texas Health Harris Methodist Hospital, Ft Worth.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ferrara', 'Affiliation': 'Department of Emergency Medicine, Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Surgery, Oregon Health & Science University, Portland.'}]",JAMA,['10.1001/jama.2020.8958']
2193,32897359,Reduction in Short-term Outpatient Consultations After a Campaign With Measles Vaccine in Children Aged 9-59 Months: Substudy Within a Cluster-Randomized Trial.,"BACKGROUND


We assessed a measles vaccination campaign's potential short-term adverse events.
METHODS


In a cluster-randomized trial assessing a measles vaccination campaign's effect on all-cause mortality and hospital admission among children aged 9-59 months in Guinea-Bissau, children received a measles vaccination (intervention) or a health check-up (control). One month to 2 months later, we visited a subgroup of children to ask mothers/guardians about outpatient consultations since enrollment. In log-binomial models, we estimated the relative risk (RR) of nonaccidental outpatient consultations.
RESULTS


Among 8319 children (4437 intervention/3882 control), 652 nonaccidental outpatient consultations occurred (322 intervention/330 control). The measles vaccination campaign tended to reduce nonaccidental outpatient consultations by 16% (RR, 0.84 [95% confidence interval {CI}, .65-1.11]), especially if caused by respiratory symptoms (RR, 0.68 [95% CI, .42-1.11]). The reduction tended to be larger in children who prior to trial enrollment had a pentavalent vaccination (diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b) as the most recent vaccination (RR, 0.61 [95% CI, .42-.89]) than in children who prior to trial enrollment had a routine measles vaccination as the most recent vaccination (RR, 0.93 [95% CI, .68-1.26]) (P = .04 for interaction).
CONCLUSIONS


In the short term, a measles vaccination campaign seems not to increase nonaccidental outpatient consultations but may reduce them.
CLINICAL TRIALS REGISTRATION


NCT03460002.",2020,"The measles vaccination campaign tended to reduce nonaccidental outpatient consultations by 16% (RR, 0.84 [95% confidence interval {CI}, .65-1.11]), especially if caused by respiratory symptoms (RR, 0.68","['Short-term Outpatient Consultations', 'children aged 9-59 months in Guinea-Bissau, children received a', 'Aged 9-59 Months', 'Children', '8319 children (4437 intervention/3882 control), 652 nonaccidental outpatient consultations occurred (322 intervention/330 control']",['measles vaccination (intervention) or a health check-up (control'],['nonaccidental outpatient consultations'],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C4517712', 'cui_str': '322'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",8319.0,0.121522,"The measles vaccination campaign tended to reduce nonaccidental outpatient consultations by 16% (RR, 0.84 [95% confidence interval {CI}, .65-1.11]), especially if caused by respiratory symptoms (RR, 0.68","[{'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Varma', 'Affiliation': 'OPEN, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'OPEN, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sanne Marie', 'Initials': 'SM', 'LastName': 'Thysen', 'Affiliation': 'OPEN, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Aksel Karl Georg', 'Initials': 'AKG', 'LastName': 'Jensen', 'Affiliation': 'OPEN, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ane Bærent', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'OPEN, University of Southern Denmark, Odense, Denmark.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piaa091']
2194,32897367,"Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET).","BACKGROUND


The development of novel broad-spectrum antibiotics, with efficacy against both gram-positive and gram-negative bacteria, has the potential to enhance treatment options for acute bacterial skin and skin structure infections (ABSSSIs). Ceftobiprole is an advanced-generation intravenous cephalosporin with broad in vitro activity against gram-positive (including methicillin-resistant Staphylococcus aureus) and gram-negative pathogens.
METHODS


TARGET was a randomized, double-blind, active-controlled, parallel-group, multicenter, phase 3 noninferiority study that compared ceftobiprole with vancomycin plus aztreonam. The Food and Drug Administration-defined primary efficacy endpoint was early clinical response 48-72 hours after treatment initiation in the intent-to-treat (ITT) population and the European Medicines Agency-defined primary endpoint was investigator-assessed clinical success at the test-of-cure (TOC) visit. Noninferiority was defined as the lower limit of the 95% CI for the difference in success rates (ceftobiprole minus vancomycin/aztreonam) >-10%. Safety was assessed through adverse event and laboratory data collection.
RESULTS


In total, 679 patients were randomized to ceftobiprole (n = 335) or vancomycin/aztreonam (n = 344). Early clinical success rates were 91.3% and 88.1% in the ceftobiprole and vancomycin/aztreonam groups, respectively, and noninferiority was demonstrated (adjusted difference: 3.3%; 95% CI: -1.2, 7.8). Investigator-assessed clinical success at the TOC visit was similar between the 2 groups, and noninferiority was demonstrated for both the ITT (90.1% vs 89.0%) and clinically evaluable (97.9% vs 95.2%) populations. Both treatment groups displayed similar microbiological success and safety profiles.
CONCLUSIONS


TARGET demonstrated that ceftobiprole is noninferior to vancomycin/aztreonam in the treatment of ABSSSIs, in terms of early clinical response and investigator-assessed clinical success at the TOC visit.
CLINICAL TRIALS REGISTRATION


NCT03137173.",2020,"Early clinical success rates were 91.3% and 88.1% in the ceftobiprole and vancomycin/aztreonam groups, respectively, and noninferiority was demonstrated (adjusted difference: 3.3%; 95% CI: -1.2, 7.8).","['Acute Bacterial Skin and Skin Structure Infections', '679 patients']","['Vancomycin Plus Aztreonam', 'ceftobiprole with vancomycin plus aztreonam', 'ceftobiprole', 'vancomycin/aztreonam']","['success rates', 'microbiological success and safety profiles', 'Early clinical success rates']","[{'cui': 'C4552481', 'cui_str': 'Acute bacterial skin and skin structure infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C1100584', 'cui_str': 'Ceftobiprole'}]","[{'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",679.0,0.67295,"Early clinical success rates were 91.3% and 88.1% in the ceftobiprole and vancomycin/aztreonam groups, respectively, and noninferiority was demonstrated (adjusted difference: 3.3%; 95% CI: -1.2, 7.8).","[{'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Overcash', 'Affiliation': 'eStudySite Clinical Research, San Diego, California, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Physician Alliance Research Center, Anaheim, California, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keech', 'Affiliation': ""Saint Joseph's Clinical Research, Anaheim, California, USA.""}, {'ForeName': 'Illia', 'Initials': 'I', 'LastName': 'Gumenchuk', 'Affiliation': 'Vinnytsia M. I. Pyrohov Regional Clinical Hospital, Vinnytsia, Ukraine.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Ninov', 'Affiliation': 'UMBAL, Pleven, Bulgaria.'}, {'ForeName': 'Yaneicy', 'Initials': 'Y', 'LastName': 'Gonzalez-Rojas', 'Affiliation': 'Optimus U Corp, Coral Gables, Florida, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Waters', 'Affiliation': 'eStudySite Clinical Research, San Diego, California, USA.'}, {'ForeName': 'Simeon', 'Initials': 'S', 'LastName': 'Simeonov', 'Affiliation': 'Clinic of Endocrinology, Medical University, Plovdiv, Bulgaria.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Saulay', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ionescu', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Jennifer I', 'Initials': 'JI', 'LastName': 'Smart', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Jones', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}, {'ForeName': 'Kamal A', 'Initials': 'KA', 'LastName': 'Hamed', 'Affiliation': 'Basilea Pharmaceutica International Ltd., Basel, Switzerland.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa974']
2195,30520252,Predictive factors associated with three years of response to HbA1c goals with exenatide QW or insulin glargine: Post-hoc analysis of the DURATION-3 study.,"This post-hoc analysis of the DURATION-3 study aimed to identify factors associated with sustained glycaemic response with exenatide once weekly (QW) or insulin glargine (IG) among patients with type 2 diabetes. Response was defined as achieving treatment target of HbA1c <7.0% (<53 mmol/mol) at Week 26; sustained responders maintained the treatment target for ≥80% of remaining visits, including one during the final 6 months. Of 467 patients, 287 (61.5%) completed 156 weeks of treatment. At Week 26, 175 patients (61.0%) (exenatide QW, n = 95; IG, n = 80) achieved an HbA1c response. At Week 156, 84 of 175 responders (48.0%) had sustained response, with more sustained responders with exenatide QW (22.7% vs 13.9% with IG; P < 0.03). Logistic regression identified three predictors of sustained response: (a) exenatide QW vs IG treatment (odds ratio, 2.584 [95% confidence interval, 1.288-5.187]; P = 0.0075), (b) lower HbA1c at Week 26 (0.139 [0.053-0.366]; P < 0.0001), and (c) lower fasting serum glucose at Week 26 (0.693 [0.541-0.888]; P = 0.0037). A regression model was used to estimate the likelihood of sustained response with either treatment. This analysis provides a helpful tool for predicting sustained response with exenatide QW or IG.",2019,"Logistic regression identified three predictors of sustained response: (a) exenatide QW vs IG treatment (odds ratio, 2.584 [95% confidence interval, 1.288-5.187]; P = 0.0075), (b) lower HbA1c at Week 26 (0.139 [0.053-0.366]; P < 0.0001), and (c) lower fasting serum glucose at Week 26 (0.693 [0.541-0.888]; P = 0.0037).","['Of 467 patients, 287 (61.5%) completed 156\u2009weeks of treatment', 'patients with type 2 diabetes']","['exenatide QW', 'exenatide QW or IG', 'exenatide QW or insulin glargine', 'exenatide once weekly (QW) or insulin glargine (IG']","['sustained response', 'fasting serum glucose']","[{'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}]",467.0,0.0348343,"Logistic regression identified three predictors of sustained response: (a) exenatide QW vs IG treatment (odds ratio, 2.584 [95% confidence interval, 1.288-5.187]; P = 0.0075), (b) lower HbA1c at Week 26 (0.139 [0.053-0.366]; P < 0.0001), and (c) lower fasting serum glucose at Week 26 (0.693 [0.541-0.888]; P = 0.0037).","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'Department of Endocrinology, Diabetology and Nutrition, Brabois Adults Hospital, University of Lorraine, CHRU de Nancy, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Trautmann', 'Affiliation': 'Diabetes Research, Hamburg, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Pharmapace, Inc., San Diego, California.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Sunder Raj D', 'Initials': 'SRD', 'LastName': 'Mudaliar', 'Affiliation': 'VA San Diego Healthcare System and Department of Medicine, University of California San Diego School of Medicine, San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13606']
2196,30709958,Serum Biomarkers for Prediction of Response to Methotrexate Monotherapy in Early Rheumatoid Arthritis: Results from the SWEFOT Trial.,"OBJECTIVE


To investigate baseline levels of 12 serum biomarkers that constitute a multibiomarker disease activity test, as predictors of response to methotrexate (MTX) in patients with early rheumatoid arthritis (eRA).
METHODS


In 298 patients from the Swedish Pharmacotherapy (SWEFOT) clinical trial, baseline serum levels of 12 proteins were analyzed for association with disease activity based on the 28-joint count Disease Activity Score (DAS28) after 3 months of MTX monotherapy using uni-/multivariate logistic regression. Primary outcome was low disease activity (LDA; DAS28 ≤ 3.2).
RESULTS


Of 298 patients, 104 achieved LDA after 3 months on MTX. Four of the 12 biomarkers [C-reactive protein (CRP), leptin, tumor necrosis factor receptor I (TNF-RI), and vascular cell adhesion molecule 1 (VCAM-1)] significantly predicted LDA based on stepwise logistic regression analysis. Dichotomization of patients using receiver-operating characteristic curve analysis-based cutoffs for these biomarkers showed significantly higher proportions with LDA among patients with lower versus higher levels of CRP or leptin (40% vs 23%, p = 0.004, and 40% vs 25%, p = 0.011, respectively), as well as among those with higher versus lower levels of TNF-RI or VCAM-1 (43% vs 27%, p = 0.004, and 41% vs 25%, p = 0.004, respectively). Combined score based on these biomarkers, adjusted for known predictors of LDA (smoking, sex, and age), associated with decreased chance of LDA (adjusted OR 0.45, 95% CI 0.32-0.62).
CONCLUSION


Low baseline levels of CRP and leptin, and high baseline levels of TNF-RI and VCAM-1 were associated with LDA after 3 months of MTX therapy in patients with eRA. Combination of these 4 biomarkers increased accuracy of prediction. [Trial registration number: NCT00764725].",2019,"Four of the 12 biomarkers [C-reactive protein (CRP), leptin, tumor necrosis factor receptor","['patients with eRA', 'Early Rheumatoid Arthritis', 'Of 298 patients, 104 achieved LDA after 3 months on', 'patients with early rheumatoid arthritis (eRA', '298 patients from the Swedish Pharmacotherapy (SWEFOT) clinical trial']","['MTX', 'methotrexate (MTX', 'Methotrexate Monotherapy']","['chance of LDA', '12 biomarkers [C-reactive protein (CRP), leptin, tumor necrosis factor receptor', 'CRP and leptin, and high baseline levels of TNF-RI and VCAM-1', 'low disease activity (LDA; DAS28 ≤ 3.2', 'TNF-RI or VCAM-1', '28-joint count Disease Activity Score (DAS28', 'CRP or leptin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",298.0,0.125877,"Four of the 12 biomarkers [C-reactive protein (CRP), leptin, tumor necrosis factor receptor","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hambardzumyan', 'Affiliation': 'From the Rheumatology Unit, Department of Medicine, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Crescendo Bioscience, South San Francisco, California, USA; Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden; Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands; Institute of Environmental Medicine (IMM), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Bolce', 'Affiliation': 'From the Rheumatology Unit, Department of Medicine, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Crescendo Bioscience, South San Francisco, California, USA; Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden; Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands; Institute of Environmental Medicine (IMM), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Johan K', 'Initials': 'JK', 'LastName': 'Wallman', 'Affiliation': 'From the Rheumatology Unit, Department of Medicine, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Crescendo Bioscience, South San Francisco, California, USA; Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden; Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands; Institute of Environmental Medicine (IMM), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'From the Rheumatology Unit, Department of Medicine, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Crescendo Bioscience, South San Francisco, California, USA; Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden; Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands; Institute of Environmental Medicine (IMM), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Saedis', 'Initials': 'S', 'LastName': 'Saevarsdottir', 'Affiliation': 'From the Rheumatology Unit, Department of Medicine, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Crescendo Bioscience, South San Francisco, California, USA; Section of Rheumatology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden; Amsterdam Rheumatology and Immunology Center, Amsterdam, the Netherlands; Institute of Environmental Medicine (IMM), Karolinska Institutet, Stockholm, Sweden. saedis.saevarsdottir@ki.se.'}]",The Journal of rheumatology,['10.3899/jrheum.180537']
2197,31203032,Using decision trees to understand the influence of individual- and neighborhood-level factors on urban diabetes and asthma.,"OBJECTIVE


To determine the influence of individual and neighborhood factors that combined are associated with asthma and diabetes in a sample of urban Philadelphians using data mining, a novel technique in public health research.
METHODS


We obtained secondary data collected between May 2011 and November 2014 on individual's health and perception of neighborhood characteristics (N = 450) and Philadelphia LandCare Program data that provided relevant environmental data for the analysis (N = 676). RapidMiner open access data mining software was used to perform decision tree analyses.
RESULTS


Individual- and neighborhood-level environmental factors were intricately related in the decision tree models, having varying influence on the outcomes of asthma and diabetes. The decision trees had high specificity (95-100) and classified factors that were associated with an absence of disease (diabetes/asthma).
CONCLUSION


Improved neighborhood-level conditions related to social and physical disorder were consistently found to be associated with an absence of both asthma and diabetes in this urban population.
POLICY IMPLICATIONS


This study illustrates the potential utility of applying data mining techniques for understanding complex public health issues.",2019,"RESULTS


Individual- and neighborhood-level environmental factors were intricately related in the decision tree models, having varying influence on the outcomes of asthma and diabetes.",['urban diabetes and asthma'],[],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",[],[],,0.0177518,"RESULTS


Individual- and neighborhood-level environmental factors were intricately related in the decision tree models, having varying influence on the outcomes of asthma and diabetes.","[{'ForeName': 'Hillary A', 'Initials': 'HA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Temple University, Rm 907, 1301 Cecil B. Moore Ave, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Coffman', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Temple University, Rm 907, 1301 Cecil B. Moore Ave, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Branas', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, 722 West 168th Street, Rm 1508, New York, NY, 10032, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Murphy', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Temple University, Rm 907, 1301 Cecil B. Moore Ave, Philadelphia, PA, 19122, USA; Water Health and Applied Microbiology Lab (WHAM-Lab), Temple University, Rm 907, 1301 Cecil B. Moore Ave, Philadelphia, PA, 19122, USA. Electronic address: heather.murphy@temple.edu.'}]",Health & place,['10.1016/j.healthplace.2019.04.009']
2198,32052214,Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077.,"Long-acting injectable PrEP could offer an alternative to daily oral PrEP, improve adherence and protection, if found acceptable, safe and effective. HPTN 077 evaluated injectable cabotegravir safety, tolerability and pharmacokinetics among HIV-uninfected males and females in sequentially-enrolled cohorts of two dosing strategies. We compared acceptability of product attributes, prevention preferences and future interest in injectable PrEP (FIIP) by region, sex-at-birth, arm and cohort and used multivariable analysis to identify FIIP determinants. Baseline injectable PrEP preferences were higher in non-U.S. sites and increased in both regions over time. In multivariable models, FIIP was most strongly associated with acceptability of product attributes, was higher in non-U.S. sites and more altruistic participants. Treatment arm and report of pain were not associated with FIIP. Injectable acceptability was highest in non-U.S. sites. Preferences for injectable versus other PrEP methods were higher among U.S. males than females, but higher among males and females in non-U.S. settings.",2020,"Preferences for injectable versus other PrEP methods were higher among U.S. males than females, but higher among males and females in non-U.S. settings.","['HIV-Uninfected Individuals', 'HIV-uninfected males and females in sequentially-enrolled cohorts of two dosing strategies']",['Long-Acting Injectable Cabotegravir (CAB LA'],"['Baseline injectable PrEP preferences', 'injectable cabotegravir safety, tolerability and pharmacokinetics', 'Injectable acceptability']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0313103,"Preferences for injectable versus other PrEP methods were higher among U.S. males than females, but higher among males and females in non-U.S. settings.","[{'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Tolley', 'Affiliation': 'Behavioral, Epidemiological & Behavioral Sciences, FHI 360, 359 Blackwell Street, Durham, NC, 27701, USA. btolley@fhi360.org.'}, {'ForeName': 'Sahar Z', 'Initials': 'SZ', 'LastName': 'Zangeneh', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chau', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Hilton', 'Initials': 'H', 'LastName': 'Humphries', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, Population Health Division, San Francisco Department of Public Health, San Francisco, CA, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Siegel', 'Affiliation': 'School of Medicine and Health Sciences, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Maseko', 'Initials': 'M', 'LastName': 'Bertha', 'Affiliation': 'UNC Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cottle', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jennings', 'Affiliation': 'Science Facilitation, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'Science Facilitation, FHI 360, Washington, DC, USA.'}, {'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'UCLA Center for Clinical AIDS Research & Education, Los Angeles, CA, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02808-2']
2199,32469138,Influenza vaccine effectiveness and disease burden in children and adolescents with sickle cell disease: 2012-2017.,"BACKGROUND


Data are limited on the burden of influenza and seasonal influenza vaccine effectiveness (VE) in children with sickle cell disease (SCD).
METHODS


We used a prospectively collected clinical registry of SCD patients 6 months to 21 years of age to determine the influenza cases per 100 patient-years, vaccination rates, and a test-negative case-control study design to estimate influenza VE against medically attended laboratory-confirmed influenza infection. Influenza-positive cases were randomly matched to test-negative controls on age and influenza season in 1:1 ratio. We used adjusted logistic regression models to compare odds ratio (OR) of vaccination in cases to controls. We calculated VE as [100% × (1 - adjusted OR)] and computed 95% confidence intervals (CIs) around the estimate.
RESULTS


There were 1037 children with SCD who were tested for influenza, 307 children (29.6%) had at least one influenza infection (338 infections, incidence rate 3.7 per 100 person-years; 95% CI, 3.4-4.1) and 56.2% of those tested received annual influenza vaccine. Overall VE pooled over five seasons was 22.3% (95% CI, -7.3% to 43.7%). Adjusted VE estimates ranged from 39.7% (95% CI, -70.1% to 78.6%) in 2015/2016 to -5.9% (95% CI, -88.4% to 40.4%) in the 2016/17 seasons. Influenza VE varied by age and was highest in children 1-5 years of age (66.6%; 95% CI, 30.3-84.0). Adjusted VE against acute chest syndrome during influenza infection was 39.4% (95% CI, -113.0 to 82.8%).
CONCLUSIONS


Influenza VE in patients with SCD varies by season and age. Multicenter prospective studies are needed to better establish and monitor influenza VE among children with SCD.",2020,"Adjusted VE against acute chest syndrome during influenza infection was 39.4% (95% CI, -113.0 to 82.8%).
","['SCD patients 6 months to 21 years of age to determine the influenza cases per 100 patient-years, vaccination rates, and a test-negative case-control study design to estimate influenza VE against medically attended laboratory-confirmed influenza infection', 'children and adolescents with sickle cell disease', 'Influenza-positive cases', 'children with SCD', 'patients with SCD varies by season and age', 'children with sickle cell disease (SCD', '1037 children with SCD who were tested for influenza, 307 children (29.6%) had at least one influenza infection (338 infections, incidence rate 3.7 per 100 person-years; 95% CI, 3.4-4.1) and 56.2% of those tested received']","['Influenza vaccine', 'annual influenza vaccine', 'Influenza VE']",['Influenza VE'],"[{'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4517756', 'cui_str': '4.1'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1037.0,0.0756212,"Adjusted VE against acute chest syndrome during influenza infection was 39.4% (95% CI, -113.0 to 82.8%).
","[{'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Kao', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lai', 'Affiliation': ""Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, Georgia.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'McAteer', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Mohnd', 'Initials': 'M', 'LastName': 'Elmontser', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Quincer', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Marianne E M', 'Initials': 'MEM', 'LastName': 'Yee', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology, Atlanta, Georgia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Tippet', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Jerris', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lane', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology, Atlanta, Georgia.'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Anderson', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Bakshi', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology, Atlanta, Georgia.'}, {'ForeName': 'Inci', 'Initials': 'I', 'LastName': 'Yildirim', 'Affiliation': 'Emory University School of Medicine, Department of Pediatrics, Division of Infectious Diseases, Atlanta, Georgia.'}]",Pediatric blood & cancer,['10.1002/pbc.28358']
2200,32897368,Suptavumab for the Prevention of Medically Attended Respiratory Syncytial Virus Infection in Preterm Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is a major cause of childhood medically attended respiratory infection (MARI).
METHODS


We conducted a randomized, double-blind, placebo-controlled phase 3 trial in 1154 preterm infants of 1 or 2 doses of suptavumab, a human monoclonal antibody that can bind and block a conserved epitope on RSV A and B subtypes, for the prevention of RSV MARI. The primary endpoint was proportion of subjects with RSV-confirmed hospitalizations or outpatient lower respiratory tract infection (LRTI).
RESULTS


There were no significant differences between primary endpoint rates (8.1%, placebo; 7.7%, 1-dose; 9.3%, 2-dose). Suptavumab prevented RSV A infections (relative risks, .38; 95% confidence interval [CI], .14-1.05 in the 1-dose group and .39 [95% CI, .14-1.07] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .0499), while increasing the rate of RSV B infections (relative risk 1.36 [95% CI, .73-2.56] in the 1-dose group and 1.69 [95% CI, .92-3.08] in the 2-dose group; nominal significance of combined suptavumab group vs placebo; P = .12). Sequenced RSV isolates demonstrated no suptavumab epitope changes in RSV A isolates, while all RSV B isolates had 2-amino acid substitution in the suptavumab epitope that led to loss of neutralization activity. Treatment emergent adverse events were balanced across treatment groups.
CONCLUSIONS


Suptavumab did not reduce overall RSV hospitalizations or outpatient LRTI because of a newly circulating mutant strain of RSV B. Genetic variation in circulating RSV strains will continue to challenge prevention efforts.
CLINICAL TRIALS REGISTRATION


NCT02325791. https://clinicaltrials.gov/ct2/show/NCT02325791.",2020,"CONCLUSIONS


Suptavumab did not reduce overall RSV hospitalizations or outpatient LRTI because of a newly circulating mutant strain of RSV B. Genetic variation in circulating RSV strains will continue to challenge prevention efforts.
","['1154 preterm infants of 1 or 2 doses of suptavumab, a human monoclonal antibody that can bind and block a conserved epitope on RSV A and B subtypes, for the prevention of RSV MARI', 'Preterm Infants']","['Suptavumab', 'placebo']","['overall RSV hospitalizations', 'RSV A infections', 'proportion of subjects with RSV-confirmed hospitalizations or outpatient lower respiratory tract infection (LRTI', 'rate of RSV B infections']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}]",1154.0,0.606894,"CONCLUSIONS


Suptavumab did not reduce overall RSV hospitalizations or outpatient LRTI because of a newly circulating mutant strain of RSV B. Genetic variation in circulating RSV strains will continue to challenge prevention efforts.
","[{'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""Department of Pediatrics, University of Colorado School of Medicine, and The Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Forleo-Neto', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Geba', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Kamal', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Cicirello', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Houghton', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Rideman', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Benvin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Hawes', 'Affiliation': 'Regeneron Genetics Center, Tarrytown, New York, USA.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Fuller', 'Affiliation': 'Regeneron Genetics Center, Tarrytown, New York, USA.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Wloga', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Jose M Novoa', 'Initials': 'JMN', 'LastName': 'Pizarro', 'Affiliation': 'Facultad Medicina Universidad del Desarrollo/CAS, Hospital Padre Hurtado, Santiago, Chile.'}, {'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Munoz', 'Affiliation': 'Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Rush', 'Affiliation': 'Department of Molecular Biosciences, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Jason S', 'Initials': 'JS', 'LastName': 'McLellan', 'Affiliation': 'Department of Molecular Biosciences, University of Texas at Austin, Austin, Texas, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Lipsich', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Christos A', 'Initials': 'CA', 'LastName': 'Kyratsous', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Sumathi', 'Initials': 'S', 'LastName': 'Sivapalasingam', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa951']
2201,32897386,Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial.,"Importance


Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear.
Objective


To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF.
Design, Setting, and Participants


This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019.
Interventions


Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter.
Main Outcomes and Measures


Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process.
Results


The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes).
Conclusion and Relevance


The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF.
Trial Registration


ClinicalTrials.gov Identifier: NCT02905032.",2020,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","['A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication', '922 patients (559 men [60.6', 'mean [SD] age, 71 [11] years) and 244 clinicians', '463 patients were randomized to the intervention arm and 459 patients to the standard care arm', 'patients with AF', 'patients with atrial fibrillation (AF', 'Patients With Atrial Fibrillation', 'patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019']",['standard care arm or care that included the use of an SDM tool (intervention arm'],"['Decision Making 12-item scale) scores', 'encounter duration', 'Measures\n\n\nQuality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process', 'SDM quality and clinician satisfaction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",922.0,0.0691682,"The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration.","[{'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Kunneman', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Branda', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ian G', 'Initials': 'IG', 'LastName': 'Hargraves', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Sivly', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alexander T', 'Initials': 'AT', 'LastName': 'Lee', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Haeshik', 'Initials': 'H', 'LastName': 'Gorr', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Burnett', 'Affiliation': 'Thrombosis Clinic and Anticoagulation Services, Park Nicollet Health Services, St Louis Park, Minnesota.'}, {'ForeName': 'Takeki', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Mississippi Medical Center, Jackson.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Jackson', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hess', 'Affiliation': 'Department of Emergency Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linzer', 'Affiliation': 'Division of General Internal Medicine, Hennepin Health, Minneapolis, Minnesota.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Brand-McCarthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Noseworthy', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2020.2908']
2202,32897437,"Open randomized trial of the effects of 6% hydroxyethyl starch 130/0.4/9 and 5% albumin on safety profile, volume efficacy, and glycocalyx degradation in hepatic and pancreatic surgery.","PURPOSE


The aim of this study was to evaluate the effects of hydroxyethyl starch (HES) 130/0.4/9 compared to 5% albumin on renal and coagulation safety profiles, volume efficacy and glycocalyx degradation in major abdominal surgery.
METHODS


The study was approved by the institutional ethics committee as a single center, open-labeled randomized trial. Fifty patients undergoing hepatic or pancreatic surgery were randomly assigned to the HES group (n = 25), who received HES 130/0.4/9, or the Albumin group (n = 25), who received 5% albumin. Ringer's acetate solution (3 ml/kg/h) and colloid solution (2 mL/kg/h) were infused and goal-directed fluid management was performed to stabilize hemodynamics. Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups. Blood loss and requirements for transfusion and vasoactive agents were also examined. Statistical analysis was performed by Mann-Whitney U tests, chi-square or Fisher exact test, with P < 0.05 taken to be significant.
RESULTS


Serum creatinine levels did not differ between the HES and Albumin groups (median: 0.67 vs. 0.75 mg/dL at anesthesia induction, 0.82 vs. 0.83 mg/dL at ICU admission, 0.67 vs. 0.73 mg/dL one day after surgery, 0.68 vs. 0.70 mg/dL one month after surgery). NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents did not differ between the groups.
CONCLUSION


HES 130/0.4/9 can be used as safely and effectively as 5% albumin. Glycocalyx degradation did not differ between use of these solutions in major abdominal surgery.",2020,"Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups.","['Fifty patients undergoing hepatic or pancreatic surgery', 'hepatic and pancreatic surgery', 'major abdominal surgery']","['6% hydroxyethyl starch', ""Ringer's acetate solution (3\xa0ml/kg/h) and colloid solution"", 'HES 130/0.4/9, or the Albumin group (n\u2009=\u200925), who received 5% albumin', 'hydroxyethyl starch (HES', 'HES']","['serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers', 'Blood loss and requirements for transfusion and vasoactive agents', 'Serum creatinine levels', 'renal and coagulation safety profiles, volume efficacy and glycocalyx degradation', 'safety profile, volume efficacy, and glycocalyx degradation', 'Glycocalyx degradation', 'NAG, coagulation parameters, hemodynamics, glycocalyx biomarkers, intraoperative blood loss, transfusion and use of vasoactive agents']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0073384', 'cui_str': ""Ringer's acetate""}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C1532580', 'cui_str': 'mL/kg/hr'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0001057', 'cui_str': 'N-Acetyl-beta-glucosaminidase'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]",50.0,0.0937781,"Perioperative changes and differences in serum creatinine, N-acetyl-beta-d-glucosaminidase (NAG), hemodynamics, coagulation parameters and glycocalyx biomarkers were compared between the groups.","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan. tsuzuki@saitama-med.ac.jp.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Koyama', 'Affiliation': 'Department of Anesthesiology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02847-y']
2203,32897461,A randomized comparison of training programs using a pelvic model designed to enhance pelvic floor examination in patients presenting with chronic pelvic pain.,"INTRODUCTION


Pelvic floor myalgia is a common cause and contributor to chronic pelvic pain [Neurourol Urodyn 4:984-1008 (2017)]. The purpose of this study was to compare in-person versus video-based teaching methods of a comprehensive assessment of the pelvic floor musculature on a pelvic model.
METHODS


A randomized controlled trial of 46 participants was conducted. The participants were randomized into two groups. Both groups were taught by the same pelvic floor physiotherapist using two different teaching methods on a pelvic model. Group 1 watched an instructional video, whereas group 2 had in-person training. Both groups underwent pre- and post-training assessments consisting of a written examination and an Objective Structured Clinical Examination (OSCE). Primary outcome measure was the change in participants' pre- and post-training assessment scores. Secondary outcome measures were perceived changes in both participants' comfort level in performing pelvic floor examination and applicability of the training program to clinical practice.
RESULTS


There was no statistically significant difference between the teaching methods in the degree of improvement of the participants' mean written assessment scores (p = 0.58), OSCE scores (p = 0.15), and perceived comfort level (p = 0.19). Participants' mean pre- and post-assessment scores improved significantly (p < 0.001). Participants reported the training program to be applicable towards their clinical practice.
CONCLUSIONS


This study demonstrates that learners' assessment of pelvic floor musculature can be enhanced using varied teaching methods on a pelvic model.",2020,"There was no statistically significant difference between the teaching methods in the degree of improvement of the participants' mean written assessment scores (p = 0.58), OSCE scores (p = 0.15), and perceived comfort level (p = 0.19).","['patients presenting with chronic pelvic pain', '46 participants was conducted']","['pre- and post-training assessments consisting of a written examination and an Objective Structured Clinical Examination (OSCE', 'training programs using a pelvic model designed to enhance pelvic floor examination', 'instructional video, whereas group 2 had in-person training']","[""degree of improvement of the participants' mean written assessment scores"", ""changes in both participants' comfort level in performing pelvic floor examination and applicability of the training program to clinical practice"", 'OSCE scores', ""change in participants' pre- and post-training assessment scores"", 'mean pre- and post-assessment scores', 'perceived comfort level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",46.0,0.0828419,"There was no statistically significant difference between the teaching methods in the degree of improvement of the participants' mean written assessment scores (p = 0.58), OSCE scores (p = 0.15), and perceived comfort level (p = 0.19).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giroux', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Saskatchewan, 1440 14th Avenue, Regina, Saskatchewan, S4P 0W5, Canada. mag640@mail.usask.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Funk', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Saskatchewan, 1440 14th Avenue, Regina, Saskatchewan, S4P 0W5, Canada.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Karreman', 'Affiliation': 'Research and Performance Support, Saskatchewan Health Authority, Regina, Saskatchewan, Canada.'}, {'ForeName': 'Huse', 'Initials': 'H', 'LastName': 'Kamencic', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Saskatchewan, 1440 14th Avenue, Regina, Saskatchewan, S4P 0W5, Canada.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Bhargava', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Saskatchewan, 1440 14th Avenue, Regina, Saskatchewan, S4P 0W5, Canada.'}]",International urogynecology journal,['10.1007/s00192-020-04487-y']
2204,32897487,Reply to the letter of Soliman et al. regarding 'Randomised comparison of a balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'.,,2020,,[],['balloon-expandable and self-expandable valve with quantitative assessment of aortic regurgitation using magnetic resonance imaging'],[],[],"[{'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003504', 'cui_str': 'Aortic valve regurgitation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",[],,0.0416543,,"[{'ForeName': 'N H M', 'Initials': 'NHM', 'LastName': 'Kooistra', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. mvoskuil@umcutrecht.nl.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': 'Stella', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01488-w']
2205,32897519,"Effect of Bacillus clausii Capsules in Reducing Adverse Effects Associated with Helicobacter pylori Eradication Therapy: A Randomized, Double-Blind, Controlled Trial.","INTRODUCTION


Antibiotic treatment can alter the gut microbiome and cause short-term gastrointestinal adverse effects (AEs). This study assessed the efficacy of lyophilized capsules containing 2 × 10 9  spores of Bacillus clausii (Enterogermina ® ; Sanofi Synthelabo) in reducing AEs associated with Helicobacter pylori eradication therapy in Italy.
METHODS


In this randomized, double-blind, single-center, phase IIIB study, 130 adult outpatients with H. pylori infection were assigned to receive one Enterogermina ®  capsule or placebo three times daily for 2 weeks (1:1). During week 1, all patients received clarithromycin 500 mg, amoxicillin 1 g, and rabeprazole 20 mg twice daily. The primary efficacy outcome was the presence of diarrhea in week 1.
RESULTS


A total of 130 patients were randomized. The incidence of diarrhea in week 1 was 29% in the B. clausii group and 48% in the placebo group [relative risk (RR) 0.61; 95% confidence interval (CI) 0.39-0.97; p = 0.03]. The incidence of diarrhea remained lower with B. clausii than with placebo in week 2 (RR 0.38; 95% CI 0.14-1.02; p = 0.0422). In week 1, the number of days without diarrhea was significantly higher in the B. clausii group than in the placebo group (6.25 vs. 5.86; p = 0.0304). In both groups, the number of days without diarrhea increased significantly (p < 0.0001) from week 1 to week 2. A total of three AEs occurred in two patients in the placebo group, but none were serious.
CONCLUSIONS


Compared with placebo, Enterogermina ®  reduced the incidence of, and the number of days with, diarrhea in patients receiving H. pylori eradication therapy. Enterogermina® was well tolerated.",2020,"In both groups, the number of days without diarrhea increased significantly (p < 0.0001) from week 1 to week 2.","['130 patients were randomized', '130 adult outpatients with H. pylori infection']","['placebo', 'Bacillus clausii Capsules', 'clarithromycin 500\xa0mg, amoxicillin 1\xa0g, and rabeprazole', 'Enterogermina ®  capsule or placebo', 'placebo, Enterogermina ®']","['incidence of diarrhea', 'Adverse Effects', 'number of days without diarrhea', 'number of days with, diarrhea', 'tolerated', 'presence of diarrhea']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",130.0,0.678921,"In both groups, the number of days without diarrhea increased significantly (p < 0.0001) from week 1 to week 2.","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Plomer', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Perez', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany.'}, {'ForeName': 'Dorothea Maren', 'Initials': 'DM', 'LastName': 'Greifenberg', 'Affiliation': 'Consumer Healthcare, Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Frankfurt am Main, Germany. Dorothea.Greifenberg@sanofi.com.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00333-2']
2206,32897568,Contralateral Effects of Eccentric Resistance Training on Immobilized Arm.,"This study compared the effects of contralateral eccentric-only (ECC) and concentric-eccentric coupled resistance training (CON-ECC) of the elbow flexors on immobilized arm. Thirty healthy participants (18-34 y) were randomly allocated to immobilization only (CTRL; n=10), immobilization and ECC (n=10) or immobilization and CON-ECC group (n=10). The non-dominant arms of all participants were immobilized (8 h·day -1  ) for 4 weeks, during which ECC and CON-ECC were performed by the dominant (non-immobilized) arm 3 times a week (3-6 sets of 10 repetitions per session) with an 80-120% and 60-90% of one concentric repetition maximum (1-RM) load, respectively, matching the total training volume. Arm circumference, 1-RM and maximal voluntary isometric contraction strength (MVIC), biceps brachii surface electromyogram amplitude (sEMG RMS  ), rate of force development (RFD) and joint position sense (JPS) were measured for both arms before and after immobilization. CTRL showed decreases (P<0.05) in MVIC (-21.7%), sEMG RMS  (-35.2%), RFD (-26.0%), 1-RM (-14.4%), JPS (-87.4%) and arm circumference (-5.1%) of the immobilized arm. These deficits were attenuated or eliminated by ECC and CON-ECC, with greater effect sizes for ECC than CON-ECC in MVIC (0.29: +12.1%, vs -0.18: -0.1%) and sEMG RMS  (0.31: 17.5% vs -0.15: -5.9%). For the trained arm, ECC showed greater effect size for MVIC than CON-ECC (0.47 vs 0.29), and increased arm circumference (+2.9%), sEMG RMS  (+77.9%) and RDF (+31.8%) greater (P<0.05) than CON-ECC (+0.6%, +15.1% and +15.8%, respectively). The eccentric-only resistance training of the contralateral arm was more effective to counteract the negative immobilization effects than the concentric-eccentric training.",2020,"These deficits were attenuated or eliminated by ECC and CON-ECC, with greater effect sizes for ECC than CON-ECC in MVIC (0.29: +12.1%, vs -0.18:",['Thirty healthy participants (18-34 y'],"['contralateral eccentric-only (ECC) and concentric-eccentric coupled resistance training (CON-ECC', 'JPS', 'Eccentric Resistance Training', 'CTRL', 'immobilization and ECC (n=10) or immobilization and CON-ECC']","['Arm circumference, 1-RM and maximal voluntary isometric contraction strength (MVIC), biceps brachii surface electromyogram amplitude (sEMG RMS  ), rate of force development (RFD) and joint position sense (JPS', 'RFD', 'MVIC', '1-RM', 'RDF', 'sEMG RMS', 'arm circumference']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0345893', 'cui_str': 'Juvenile polyposis syndrome'}, {'cui': 'C2927794', 'cui_str': 'RFD'}]",30.0,0.0218477,"These deficits were attenuated or eliminated by ECC and CON-ECC, with greater effect sizes for ECC than CON-ECC in MVIC (0.29: +12.1%, vs -0.18:","[{'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Valdes', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ramirez', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Perez', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Garcia-Vicencio', 'Affiliation': 'Physiology of Exercise and Activities in Extreme Conditions Unit, Operational Environments Department, French Armed Forces Biomedical Research Institute (IRBA), Brétigny sur Orge, France.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Nosaka', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Penailillo', 'Affiliation': 'Exercise Science Laboratory, School of Kinesiology, Faculty of Medicine, Universidad Finis Terrae, Santiago, Chile.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13821']
2207,32897569,Rituximab and glatiramer-acetate in secondary-progressive multiple sclerosis: A randomized-clinical trial.,"BACKGROUND


Treatment options for secondary progressive multiple sclerosis (SPMS) are limitedly investigated. We aimed to compare the efficacy of rituximab (RTX) and Glatiramer acetate (GA) in SPMS patients.
METHOD


This open, randomized-clinical trial was conducted on 84 SPMS patients, assigned to receive RTX or GA for 12 months. In RTX group patients received 1g intravenous RTX primarily and then every 6-months. In GA group patients received 40mg of GA 3-times/week subcutaneously. We measured EDSS as the primary outcome, and neuroimaging findings, relapse rate (RR) and side-effects, as the secondary outcomes.
RESULTS


Seventy-three patients completed the study (37 and 36 in RTX and GA groups, respectively). The mean EDSS increased from 3.05±1.01 to 4.14±0.91 in RTX group (p<0.001) and from 3.22±1.20 to 4.60±0.67 in GA group (p<0.001). No statistically significant difference was observed in EDSS between two groups (F(1, 67)=3.377; p=0.071). The number of active lesions in brain and cervical spine decreased with no difference between groups (p>0.05). Also, RR decreased in both groups without significant difference between them (F(1, 67)=0.390; p=0.534). Non-serious complications were observed in both groups.
CONCLUSION


Neither RTX nor GA affect EDSS in SPMS patients. They are equally effective in the relapse control of these patients.",2020,The number of active lesions in brain and cervical spine decreased with no difference between groups (p>0.05).,"['84 SPMS patients', 'SPMS patients', 'secondary-progressive multiple sclerosis', 'secondary progressive multiple sclerosis (SPMS']","['Rituximab and glatiramer-acetate', 'rituximab (RTX) and Glatiramer acetate (GA', 'RTX or GA']","['number of active lesions in brain and cervical spine', 'mean EDSS', 'RR', 'neuroimaging findings, relapse rate (RR) and side-effects', 'EDSS']","[{'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",84.0,0.0658166,The number of active lesions in brain and cervical spine decreased with no difference between groups (p>0.05).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Cheshmavar', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Mirmosayyeb', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Badihian', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Badihian', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Shaygannejad', 'Affiliation': 'Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Acta neurologica Scandinavica,['10.1111/ane.13344']
2208,32897570,Effects of the dual endothelin receptor antagonist aprocitentan on body weight and fluid homeostasis in healthy subjects on a high sodium diet.,"Aprocitentan is a novel, oral, dual endothelin receptor antagonist (ERA) in development in difficult-to-control hypertension. As fluid retention and edema are concerns with ERAs, we investigated whether aprocitentan causes weight gain in healthy subjects on a high sodium diet and explored potential mechanisms if occurring. This double-blind, randomized, placebo-controlled, crossover study enrolled 28 subjects. Three doses of aprocitentan (10, 25 or 50 mg/day for 9 days) were compared to placebo. Increases in body weight were observed with aprocitentan (placebo-corrected mean weight gains [90% CI]) of 0.43 [0.05, 0.80], 0.77 [0.03, 1.51] and 0.83 [0.33, 1.32] kg at 10, 25, and 50 mg, respectively. Decreases in hemoglobin and uric acid were observed. Plasma volume increased at most by 5.5% without dose-response relationship. Urinary sodium excretion decreased at 10 mg and 25 mg but not at 50 mg. Therefore, aprocitentan produced moderate weight increases in healthy subjects on high sodium diet, without obvious sodium retention.",2020,"Increases in body weight were observed with aprocitentan (placebo-corrected mean weight gains [90% CI]) of 0.43 [0.05, 0.80], 0.77 [0.03, 1.51] and 0.83 [0.33, 1.32","['enrolled 28 subjects', 'healthy subjects on a high sodium diet', 'healthy subjects']","['dual endothelin receptor antagonist aprocitentan', 'placebo', 'endothelin receptor antagonist (ERA']","['Plasma volume', 'body weight and fluid homeostasis', 'hemoglobin and uric acid', 'body weight', 'Urinary sodium excretion']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0452340', 'cui_str': 'High sodium diet'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1134681', 'cui_str': 'Endothelin receptor antagonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032127', 'cui_str': 'Blood plasma volume'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",28.0,0.0842162,"Increases in body weight were observed with aprocitentan (placebo-corrected mean weight gains [90% CI]) of 0.43 [0.05, 0.80], 0.77 [0.03, 1.51] and 0.83 [0.33, 1.32","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gueneau de Mussy', 'Affiliation': 'Service of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Patricia N', 'Initials': 'PN', 'LastName': 'Sidharta', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.'}, {'ForeName': 'Gregoire', 'Initials': 'G', 'LastName': 'Wuerzner', 'Affiliation': 'Service of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Maillard', 'Affiliation': 'Service of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Guérard', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Iglarz', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Pharmacology, Allschwil, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Flamion', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Strategic Development, Allschwil, Switzerland.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Burnier', 'Affiliation': 'Service of Nephrology and Hypertension, Department of Medicine, University Hospital, Lausanne, Switzerland.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2043']
2209,32897605,"Transesophageal Echocardiography - Dysphagia Risk in Acute Stroke: A prospective, blind, randomized and controlled clinical trial (T.E.D.R.A.S.).","INTRODUCTION


Dysphagia is common in acute stroke and deteriorates the overall outcome. Transesophageal echocardiography (TEE) builds the diagnostic workup of stroke etiology and is known as cause of postoperative dysphagia in cardiac surgery. The prevalence of dysphagia in acute stroke patients undergoing TEE remains unknown. The aim of T.E.D.R.A.S. was to assess the influence of TEE on swallowing among acute stroke patients.
METHODS


T.E.D.R.A.S. as a prospective, blind, randomized, controlled trial included patients with acute stroke in two groups. Simple unrestricted randomization was performed, and examiners were blinded for each other´s results. Swallowing was tested using Flexible Endoscopic Evaluation of Swallowing (FEES) at three different intervals in the intervention group (IG) (24 hours before, immediately after and 24 hours after TEE) and within the control group (CG) (FEES on three consecutive days and TEE earliest after the last FEES). Validated scores assessed dysphagia severity for all time points as primary outcome measures.
RESULTS


34 patients were randomized in the IG (n=19) and the CG (n=15). Key findings using repeated measures between group comparisons shows significant increases in the IG among the following dysphagia measures: 1.) Secretion severity score (immediately after TEE: p <0.001, 24h after TEE: p<0.001). 2.) Penetration-aspiration-scale for saliva (immediately after TEE: p <0.001; 24h after TEE: p= 0.007), for small (immediately after TEE: p=0.009) and for large liquid boli (immediately after TEE: p=0.009, 24h after TEE: p=0.025).
CONCLUSION


The results indicate a negative influence of TEE on swallowing in acute stroke patients for at least for hours.",2020,"Swallowing was tested using Flexible Endoscopic Evaluation of Swallowing (FEES) at three different intervals in the intervention group (IG) (24 hours before, immediately after and 24 hours after TEE) and within the control group (CG)","['34 patients', 'acute stroke patients', 'Acute Stroke', 'acute stroke patients undergoing TEE remains unknown', 'patients with acute stroke in two groups']","['CG', 'TEE', 'Transesophageal echocardiography (TEE', 'Transesophageal Echocardiography - Dysphagia Risk', 'control group (CG']","['dysphagia severity', 'Flexible Endoscopic Evaluation of Swallowing (FEES', 'Penetration-aspiration-scale for saliva', 'prevalence of dysphagia', 'Secretion severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",34.0,0.0945988,"Swallowing was tested using Flexible Endoscopic Evaluation of Swallowing (FEES) at three different intervals in the intervention group (IG) (24 hours before, immediately after and 24 hours after TEE) and within the control group (CG)","[{'ForeName': 'Samra', 'Initials': 'S', 'LastName': 'Hamzic', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Braun', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Butz', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Khilan', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Department of Neurology / Stroke Unit, Gesundheitszentrum Wetterau, Friedberg, Hesse, Germany.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Yeniguen', 'Affiliation': 'Heart and Brain Research Group, Kerckhoff Clinic GmbH, Heart-, Lung-, Vascular- and Rheumatic Centre Bad Nauheim, Germany.'}, {'ForeName': 'Tibo', 'Initials': 'T', 'LastName': 'Gerriets', 'Affiliation': 'Department of Neurology, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schramm', 'Affiliation': 'Heart and Brain Research Group, Kerckhoff Clinic GmbH, Heart-, Lung-, Vascular- and Rheumatic Centre Bad Nauheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Juenemann', 'Affiliation': 'Heart and Brain Research Group, Kerckhoff Clinic GmbH, Heart-, Lung-, Vascular- and Rheumatic Centre Bad Nauheim, Germany.'}]",European journal of neurology,['10.1111/ene.14516']
2210,32897622,Microneedling in androgenetic alopecia; comparing two different depths of microneedles.,"BACKGROUND


Microneedling has shown to have positive therapeutic effects in treatment of androgenetic alopecia (AGA), however, the best microneedling protocol is still controversial.
AIMS


Investigating effect of microneedling with 2 different depths of penetration on promoting hair growth in patients with AGA.
METHODS


sixty patients, in the age of 18-45 years old with moderate and severe AGA were allocated into 3 groups of control: treatment with minoxidil 5% lotion; group A: treatment with minoxidil 5% lotion and biweekly microneedling with a depth of 1.2 mm and group B: treatment with minoxidil 5% lotion and biweekly microneedling with a depth of 0.6 mm during 12 weeks. Efficacy parameters including change of hair count and hair thickness from baseline and assessment of hair growth by patient and investigator were evaluated.
RESULTS


Compared to the base-line, a significant increase in hair count and hair thickness was observed in all three groups after completion of the treatment course (P < 0.05). The mean rise in hair count (P = 0.017) and hair thickness (P = 0.007) were significantly greater in group B compared to control group. Investigator's evaluation of hair regrowth was significantly greater in group A (P = 0.04) and group B (P = 0.007) compared to control group.
CONCLUSION


microneedling with a depth of 0.6 mm in combination with minoxidil is more effective than minoxidil monotherapy in patients with AGA in terms of hair count and hair thickness. This depth of penetration tended to be more beneficial than depth of 1.2 mm.",2020,The mean rise in hair count (P = 0.017) and hair thickness (P = 0.007) were significantly greater in group B compared to control group.,"['patients with AGA', 'sixty patients, in the age of 18-45 years old with moderate and severe AGA']","['minoxidil', 'minoxidil 5% lotion', 'minoxidil monotherapy', 'minoxidil 5% lotion and biweekly microneedling with a depth of 1.2 mm and group B: treatment with minoxidil 5% lotion']","['androgenetic alopecia', 'hair regrowth', 'hair thickness', 'change of hair count and hair thickness from baseline and assessment of hair growth', 'hair count and hair thickness', 'mean rise in hair count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0232407', 'cui_str': 'Hair growth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",60.0,0.0170489,The mean rise in hair count (P = 0.017) and hair thickness (P = 0.007) were significantly greater in group B compared to control group.,"[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Faghihi', 'Affiliation': 'Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Samin', 'Initials': 'S', 'LastName': 'Nabavinejad', 'Affiliation': 'Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Fatemi Naeini', 'Affiliation': 'Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Iraji', 'Affiliation': 'Department of Dermatology, Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13714']
2211,32897665,Effect of Electrical Muscle Stimulation on Upper and Lower Limb Muscles in Critically Ill Patients: A Two-Center Randomized Controlled Trial.,"OBJECTIVES


Electrical muscle stimulation is widely used to enhance lower limb mobilization. Although upper limb muscle atrophy is common in critically ill patients, electrical muscle stimulation application for the upper limbs has been rarely reported. The purpose of this study was to investigate whether electrical muscle stimulation prevents upper and lower limb muscle atrophy and improves physical function.
DESIGN


Randomized controlled trial.
SETTING


Two-center, mixed medical/surgical ICU.
PATIENTS


Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days.
INTERVENTIONS


Forty-two patients were randomly assigned to the electrical muscle stimulation (n = 17) or control group (n = 19).
MEASUREMENTS AND MAIN RESULTS


Primary outcomes were change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5. Secondary outcomes included occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels. The change in biceps brachii muscle thickness was -1.9% versus -11.2% in the electrical muscle stimulation and control (p = 0.007) groups, and the change in cross-sectional area was -2.7% versus -10.0% (p = 0.03). The change in rectus femoris muscle thickness was -0.9% versus -14.7% (p = 0.003) and cross-sectional area was -1.7% versus -10.4% (p = 0.04). No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups. The length of hospitalization was shorter in the electrical muscle stimulation group (23 d [19-34 d] vs 40 d [26-64 d]) (p = 0.04). On day 3, the change in the branched-chain amino acid level was lower in the electrical muscle stimulation group (40.5% vs 71.5%; p = 0.04).
CONCLUSIONS


In critically ill patients, electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis and decreased the length of hospitalization.",2020,No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups.,"['Two-center, mixed medical/surgical ICU', 'Critically Ill Patients', 'Adult patients who were expected to be mechanically ventilated for greater than 48 hours and stay in the ICU for greater than 5 days']","['Electrical Muscle Stimulation', 'electrical muscle stimulation']","['cross-sectional area', 'electrical muscle stimulation prevented upper and lower limb muscle atrophy and attenuated proteolysis', 'biceps brachii muscle thickness', 'ICU-acquired weakness', 'length of hospitalization', 'branched-chain amino acid level', 'occurrence of ICU-acquired weakness, ICU mobility scale, length of hospitalization, and amino acid levels', 'change in muscle thickness and cross-sectional area of the biceps brachii and rectus femoris from day 1 to 5', 'change in rectus femoris muscle thickness', 'ICU mobility scale']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1513053', 'cui_str': 'Medical Surgical Nursing'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0597304', 'cui_str': 'Protein Degradation'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1328436', 'cui_str': 'Amino acid level'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",42.0,0.0549303,No significant difference was found in ICU-acquired weakness (13% vs 40%; p = 0.20) and ICU mobility scale (3 vs 2; p = 0.42) between the groups.,"[{'ForeName': 'Nobuto', 'Initials': 'N', 'LastName': 'Nakanishi', 'Affiliation': '1Emergency and Critical Care Medicine, Tokushima University Hospital, Tokushima, Japan. 2Emergency and Disaster Medicine, Tokushima University Hospital, Tokushima, Japan. 3Department of Nutrition and Metabolism, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan. 4Intensive Care Medicine, Tokushima Prefectural Central Hospital, Tokushima, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Oto', 'Affiliation': ''}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Tsutsumi', 'Affiliation': ''}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Yoshitoyo', 'Initials': 'Y', 'LastName': 'Ueno', 'Affiliation': ''}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Nakataki', 'Affiliation': ''}, {'ForeName': 'Taiga', 'Initials': 'T', 'LastName': 'Itagaki', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sakaue', 'Affiliation': ''}, {'ForeName': 'Masaji', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004522']
2212,32579613,A novel scaling methodology to reduce the biases associated with missing data from commercial activity monitors.,"BACKGROUND


Commercial physical activity monitors have wide utility in the assessment of physical activity in research and clinical settings, however, the removal of devices results in missing data and has the potential to bias study conclusions. This study aimed to evaluate methods to address missingness in data collected from commercial activity monitors.
METHODS


This study utilised 1526 days of near complete data from 109 adults participating in a European weight loss maintenance study (NoHoW). We conducted simulation experiments to test a novel scaling methodology (NoHoW method) and alternative imputation strategies (overall/individual mean imputation, overall/individual multiple imputation, Kalman imputation and random forest imputation). Methods were compared for hourly, daily and 14-day physical activity estimates for steps, total daily energy expenditure (TDEE) and time in physical activity categories. In a second simulation study, individual multiple imputation, Kalman imputation and the NoHoW method were tested at different positions and quantities of missingness. Equivalence testing and root mean squared error (RMSE) were used to evaluate the ability of each of the strategies relative to the true data.
RESULTS


The NoHoW method, Kalman imputation and multiple imputation methods remained statistically equivalent (p<0.05) for all physical activity metrics at the 14-day level. In the second simulation study, RMSE tended to increase with increased missingness. Multiple imputation showed the smallest RMSE for Steps and TDEE at lower levels of missingness (<19%) and the Kalman and NoHoW methods were generally superior for imputing time in physical activity categories.
CONCLUSION


Individual centred imputation approaches (NoHoW method, Kalman imputation and individual Multiple imputation) offer an effective means to reduce the biases associated with missing data from activity monitors and maximise data retention.",2020,"The NoHoW method, Kalman imputation and multiple imputation methods remained statistically equivalent (p<0.05) for all physical activity metrics at the 14-day level.",['109 adults participating in a European weight loss maintenance study (NoHoW'],[],"['14-day physical activity estimates for steps, total daily energy expenditure (TDEE) and time in physical activity categories', 'Equivalence testing and root mean squared error (RMSE']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",109.0,0.0229316,"The NoHoW method, Kalman imputation and multiple imputation methods remained statistically equivalent (p<0.05) for all physical activity metrics at the 14-day level.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': ""O'Driscoll"", 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Turicchi', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Duarte', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Michalowska', 'Affiliation': 'Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Medical Faculty, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Larsen', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Palmeira', 'Affiliation': 'Faculdade de Motricidade Humana, Universidade de Lisboa, Lisbon, Portugal.'}, {'ForeName': 'B L', 'Initials': 'BL', 'LastName': 'Heitmann', 'Affiliation': 'Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region, Denmark.'}, {'ForeName': 'G W', 'Initials': 'GW', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics & Statistics Scotland, Aberdeen, United Kingdom.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Stubbs', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, University of Leeds, Leeds, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0235144']
2213,32579616,"Social support, social context and nonadherence to treatment in young senior patients with multimorbidity and polypharmacy followed-up in primary care. MULTIPAP Study.","OBJECTIVE


To estimate the prevalence of nonadherence to treatment and its relationship with social support and social context in patients with multimorbidity and polypharmacy followed-up in primary care.
METHODS


This was an observational, descriptive, cross-sectional, multicenter study with an analytical approach. A total of 593 patients between 65-74 years of age with multimorbidity (≥3 diseases) and polypharmacy (≥5 drugs) during the last three months and agreed to participate in the MULTIPAP Study. The main variable was adherence (Morisky-Green). The predictors were social support (structural support and functional support (DUFSS)); sociodemographic variables; indicators of urban objective vulnerability; health-related quality of life (EQ-5D-5L-VAS & QALY); and clinical variables. Descriptive, bivariate and multivariate analyses with logistic regression models and robust estimators were performed.
RESULTS


Four out of ten patients were nonadherent, 47% had not completed primary education, 28.7% had an income ≤1050 €/month, 35% reported four or more IUVs, and the average perceived health-related quality of life (HRQOL) EQ-5D-5L-VAS was 65.5. The items that measure functional support, with significantly different means between nonadherent and adherent patients were receiving love and affection (-0.23; 95%CI: -0.40;-0.06), help when ill (-0.25; 95%CI: -0.42;-0.08), useful advice (-0.20; 95%CI: -0.37;-0.02), social invitations (-0.22; 95%CI:-0.44;-0.01), and recognition (-0.29; 95%CI:-0.50;-0.08). Factors associated with nonadherence were belonging to the medium vs. low tertile of functional support (0.62; 95%CI: 0.42;0.94), reporting less than four IUVs (0.69; 95%CI: 0.46;1.02) and higher HRQOL perception (0.98; 95%CI: 0.98;0.99).
CONCLUSIONS


Among patients 65-74 years of age with multimorbidity and polypharmacy, lower functional support was related to nonadherence to treatment. The nonadherence decreased in those patients with higher functional support, lower urban vulnerability and higher perceived health status according to the visual analog scale of health-related quality of life.",2020,"The items that measure functional support, with significantly different means between nonadherent and adherent patients were receiving love and affection (-0.23; 95%CI: -0.40;-0.06), help when ill (-0.25; 95%CI: -0.42;-0.08), useful advice (-0.20; 95%CI: -0.37;-0.02), social invitations (-0.22; 95%CI:-0.44;-0.01), and recognition (-0.29; 95%CI:-0.50;-0.08).","['593 patients between 65-74 years of age with multimorbidity (≥3 diseases) and polypharmacy (≥5 drugs) during the last three months and agreed to participate in the MULTIPAP Study', 'young senior patients with multimorbidity and polypharmacy followed-up in primary care', 'patients with multimorbidity and polypharmacy followed-up in primary care', 'patients 65-74 years of age with multimorbidity and polypharmacy, lower functional support was related to nonadherence to treatment']",[],"['visual analog scale of health-related quality of life', 'social support (structural support and functional support (DUFSS)); sociodemographic variables; indicators of urban objective vulnerability; health-related quality of life (EQ-5D-5L-VAS & QALY); and clinical variables', 'HRQOL perception', 'average perceived health-related quality of life (HRQOL) EQ-5D-5L-VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",593.0,0.0694444,"The items that measure functional support, with significantly different means between nonadherent and adherent patients were receiving love and affection (-0.23; 95%CI: -0.40;-0.06), help when ill (-0.25; 95%CI: -0.42;-0.08), useful advice (-0.20; 95%CI: -0.37;-0.02), social invitations (-0.22; 95%CI:-0.44;-0.01), and recognition (-0.29; 95%CI:-0.50;-0.08).","[{'ForeName': 'Cristina M', 'Initials': 'CM', 'LastName': 'Lozano-Hernández', 'Affiliation': 'Research Unit, Primary Health Care Management, Madrid, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'López-Rodríguez', 'Affiliation': 'Research Unit, Primary Health Care Management, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Leiva-Fernández', 'Affiliation': 'Research Network in Health Services in Chronic Diseases (REDISSEC) ISCIII, Madrid, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Calderón-Larrañaga', 'Affiliation': 'Research Network in Health Services in Chronic Diseases (REDISSEC) ISCIII, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Barrio-Cortes', 'Affiliation': 'Research Unit, Primary Health Care Management, Madrid, Spain.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Gimeno-Feliu', 'Affiliation': 'Research Network in Health Services in Chronic Diseases (REDISSEC) ISCIII, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Poblador-Plou', 'Affiliation': 'Research Network in Health Services in Chronic Diseases (REDISSEC) ISCIII, Madrid, Spain.'}, {'ForeName': 'Isabel Del', 'Initials': 'ID', 'LastName': 'Cura-González', 'Affiliation': 'Research Unit, Primary Health Care Management, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0235148']
2214,32681911,Effects of Induced Astigmatism on Spectral Domain-OCT Angiography Quantitative Metrics.,"PURPOSE


To analyze the effect of induced astigmatism on en-face spectral-domain optical coherence tomography angiography quantitative metrics.
DESIGN


Prospective crossover study.
METHODS


Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a 3 × 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA). Quantitative parameters, including foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD) were corrected for magnification secondary to axial length and analyzed. Univariate linear regressions were performed within each eye to correlate quantitative metrics to the level of an induced astigmatic cylinder.
RESULTS


Fifteen eyes from 15 patients were imaged. Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001). For every 1-D increase in induced astigmatism, the resulting decrease in the inner ring superior quadrant was 12% greater for VD and 16% greater for PD versus that in the inferior quadrant. The resulting decrease in the inner ring nasal quadrant was 40% greater for VD and 48% greater for PD versus that in the temporal quadrant.
CONCLUSIONS


Increasing levels of induced WTR astigmatism correlated with globally diminishing VD and PD, was more symmetrical for vertical than horizontal quadrants, and was most pronounced nasally. This may be due to a high prevalence of horizontally oriented vessels nasally and the horizontal optical defocus induced by WTR astigmatism.",2020,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","['Fifteen eyes from 15 patients were imaged', 'Normal eyes without astigmatism and with 0.75, 1.75, and 2.75 diopters (D) of with-the-rule (WTR) astigmatism were imaged using a']","['Induced Astigmatism', '3\xa0× 3-mm scan pattern SD-OCTA CIRRUS 5000 HD-OCT with AngioPlex (Carl Zeiss Meditec, Dublin, CA, USA']","['VD and PD', 'foveal avascular zone metrics, parafoveal vessel length density (VD), and perfusion density (PD', 'inner ring nasal quadrant', 'Spectral Domain-OCT Angiography Quantitative Metrics', 'induced WTR astigmatism']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1719796', 'cui_str': 'With-the-rule astigmatism'}]",15.0,0.026434,"Every 1-D increase in induced WTR astigmatism was associated with a statistically significant decrease in VD and PD within all Early Treatment Diabetic Retinopathy Study inner ring quadrants; however, especially more so nasally (VD: 0.63; P < .001; PD: 0.0089; P = .001).","[{'ForeName': 'Jesse J', 'Initials': 'JJ', 'LastName': 'Jung', 'Affiliation': 'East Bay Retina Consultants, Inc., Oakland, California, USA; Department of Ophthalmology, Universtiy of California, San Francisco, San Francisco, California, USA. Electronic address: jung.jesse@gmail.com.'}, {'ForeName': 'Yu Qiang', 'Initials': 'YQ', 'LastName': 'Soh', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA; Silicon Valley Eyecare Optometry, Santa Clara, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Durbin', 'Affiliation': 'Carl Zeiss Meditec, Inc., Dublin, California, USA.'}, {'ForeName': 'Quan V', 'Initials': 'QV', 'LastName': 'Hoang', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS Medical School, Singapore, Singapore; Department of Ophthalmology, Edward S. Harkness Eye Institute, Columbia College of Physicians and Surgeons, New York, New York, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.07.005']
2215,32854474,[Clinical study on perinatal outcomes of 80 cases with unicornuate uterus pregnancy].,"Objective:  To analyze the perinatal outcomes of unicornuate uterus pregnancy.  Methods:  The clinical data of patients with unicornuate uterus pregnancy who delivered between January 2009 and December 2018 in Women's Hospital, School of Medicine, Zhejiang University, were reviewed retrospectively. Live birth was defined as the delivery of a baby after at least 28 weeks gestational age. Ninety-eight patients were diagnosed as unicornuate uterus, while 4 cases of stillbirth and 4 cases of twin pregnancy and 10 cases of incomplete data were excluded, and 80 patients with unicornuate uterus were included in the observation group. By matching the age, gestational age and delivery mode, 160 patients were randomly selected as the control group. The perinatal outcomes such as delivery mode, cesarean section indication sequence, postpartum hemorrhage, vaginal delivery time, newborn birth weight and Apgar score were analyzed retrospectively.  Results:  In the unicornuate uterus group, there were 10 cases of vaginal delivery and 70 cases of cesarean section, among which the primary indication of premature cesarean section and full-term cesarean section was abnormal fetal position, accounting for 7/18 and 50.0% (26/52), respectively. While in the control group, there were 20 cases of vagianl delivery and 140 cases of cesarean section, among which the main indications of premature cesarean section were placenta previa, intrahepatic cholestasis during pregnancy and scar uterus, accounting for 19.4% (7/36), and the primary indication of full-term cesarean section was abnormal fetal position, accounting for 23.1% (24/104). The postpartum hemorrhage of the vaginal delivery in the unicornuate uterus group and the control group was (319±161) and (261±152) ml, respectively, and the postpartum hemorrhage of the cesarean section delivery was (257±106) and (272±123) ml, respectively. There were no significant differences between the two groups statistically (all  P >0.05). The time of the first stage of labor was (502±386) and (465±296) minutes in the unicornuate uterus group and the control group, and the time of the second stage was (74±73) and (47±30) minutes, respectively. There were no significant differences between the two groups statistically (all  P >0.05). The neonatal birth weight in the unicornuate uterus group and the control group was (3 018±548) and (3 080±562) g, respectively, and there was no significant difference between the two groups statistically ( P =0.42). According to preterm birth and different pre-pregnancy body mass index, the neonatal birth weight of the two groups were compared, and the differences were not statistically significant (all  P >0.05). One-minute Apgar score of premature in the unicornuate uterus group and the control group were 10 (9.25-10) and 10 (10-10), 5-minute Apgar score were 10 (10-10) and 10 (10-10), respectively. One-minute Apgar score of full-term in the unicornuate uterus group and the control group were 10 (10-10) and 10 (10-10), 5-minute Apgar score were 10 (10-10) and 10 (10-10), respectively. There were no statistically significant differences between the two groups, respectively (all  P >0.05).  Conclusions:  The patients with unicornuate uterus could give birth vaginally in the absence of other operation indications. The perinatal outcome of women with unicornuate uterus is similar to that of women with non-uterine abnormalities. It is found that the abnormal fetal position with unicornuate uterus is the main reason for cesarean section.",2020,There were no significant differences between the two groups statistically (all  P >0.05).,"[""patients with unicornuate uterus pregnancy who delivered between January 2009 and December 2018 in Women's Hospital, School of Medicine, Zhejiang University, were reviewed retrospectively"", 'women with non-uterine abnormalities', 'Ninety-eight patients were diagnosed as unicornuate uterus, while 4 cases of stillbirth and 4 cases of twin pregnancy and 10 cases of incomplete data were excluded, and 80 patients with unicornuate uterus were included in the observation group', '80 cases with unicornuate uterus pregnancy']",[],"['postpartum hemorrhage of the cesarean section delivery', 'neonatal birth weight', 'Live birth', 'perinatal outcomes such as delivery mode, cesarean section indication sequence, postpartum hemorrhage, vaginal delivery time, newborn birth weight and Apgar score', 'postpartum hemorrhage of the vaginal delivery', '5-minute Apgar score', 'premature cesarean section were placenta previa, intrahepatic cholestasis', 'premature cesarean section and full-term cesarean section']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266389', 'cui_str': 'Uterus unicornis'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0266383', 'cui_str': 'Congenital uterine anomaly'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0008372', 'cui_str': 'Intrahepatic cholestasis'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",160.0,0.0287799,There were no significant differences between the two groups statistically (all  P >0.05).,"[{'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'X X', 'Initials': 'XX', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ''}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200107-00019']
2216,32854477,[Expression and significance of PD-1 and PD-L1 in the specimens of epithelial ovarian cancer].,"Objective:  To examine the expression of programmed cell death 1 (PD-1) and its ligand (PD-L1) in epithelial ovarian cancer (EOC) tissues, and investigate the correlation among their expression, clinicopathological features and prognosis.  Methods:  The specimens of 180 patients with EOC treated in the First Affiliated Hospital of Dalian Medical University from October 2002 to December 2013 were confirmed by pathological examination. The pathological tissue specimens of subtypes ，included 120 cases of serous carcinoma, 30 cases of mucinous carcinoma, 20 cases of endometrioid carcinoma, and 20 cases of clear cell carcinoma. The normal paracancerous tissues of 50 cases randomly selected from the 180 patients as control group. Immunohistochemical SP method was used to detect the expressions of both PD-1 and PD-L1 in epithelial ovarian cancer tissues, and the relationships among their expressions,the clinicopathological parameters and prognosis were respectively analyzed.  Results:  （1） PD-1 was expressed in lymphocytes infiltrated in EOC tissues, and PD-L1 was expressed in the cell membranes of cancer tissues. In all EOC cases, 33 cases (18.3%, 33/180) of both PD-1 and PD-L1 were highly expressed, and only 1 (2.0%, 1/50) of control group showed high expression. There was statistically significant difference between two groups ( P <0.01). (2) Among the four subtypes tissue specimens of EOC, the high expression rate of PD-1 was 25.0% (30/120) for serous carcinoma, 3/15 for endometrioid carcinoma, 0 (0/30) for mucinous carcinoma, and 0 (0/15) for clear cell carcinoma. The high expression rate of PD-L1 was 23.3% (28/120) for serous carcinoma, 3.3% (1/30) for mucinous carcinoma, 2/15 for endometrioid carcinoma, and 2/15 for clear cell carcinoma. Both PD-1 and PD-L1 expressions in the four sub-types of tissue specimens were significantly different ( P <0.05). The high expression rate of both PD-1 and PD-L1 was 9.2% (8/87) in the early stage and 26.9% (25/93) in the late stage. There was a statistically significant difference between the two groups ( P <0.01). Similarly, the expression of both PD-1 and PD-L1 were significantly higher in the cases of high-grade EOC （type Ⅱ） than those of low-grade （type Ⅰ） and in the cases of EOC distributed bilaterally than that distributed unilaterally, and there were statistically significant differences ( P <0.05). (3) The Kaplan-Meier survival analysis showed that the survival time were respectively 35 and 36 months in the cases with high expressions of both PD-1 and PD-L1, and the survival time were the same as 61 months in the cases with low expression of both PD-1 and PD-L1, and the comparison was statistically significant ( P <0.05).  Conclusions:  The expression levels of PD-1 and PD-L1 in EOC tissues are higher than those in adjacent tissues, especially in serous carcinomas. The expression of both PD-1 and PD-L1 is higher in specimens of the patients with advanced stages. The results showed that the high expression of both PD-1 and PD-L1 is an indicator of poor prognosis of patients suffering from EOC.",2020,"The expression levels of PD-1 and PD-L1 in EOC tissues are higher than those in adjacent tissues, especially in serous carcinomas.","['180 patients with EOC treated in the First Affiliated Hospital of Dalian Medical University from October 2002 to December 2013 were confirmed by pathological examination', 'specimens of epithelial ovarian cancer', '50 cases randomly selected from the 180 patients as control group', '120 cases of serous carcinoma, 30 cases of mucinous carcinoma, 20 cases of endometrioid carcinoma, and 20 cases of clear cell carcinoma']",[],"['high expression rate of PD-L1', 'expression of both PD-1 and PD-L1', 'PD-1 and PD-L1 expressions', 'expression levels of PD-1 and PD-L1 in EOC tissues', 'survival time', 'expression rate of PD-1', 'Expression and significance of PD-1 and PD-L1', 'high expression rate of both PD-1 and PD-L1', 'lymphocytes infiltrated in EOC tissues, and PD-L1']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0206701', 'cui_str': 'Serous cystadenocarcinoma'}, {'cui': 'C0007130', 'cui_str': 'Mucinous adenocarcinoma'}, {'cui': 'C0206687', 'cui_str': 'Endometrioid carcinoma'}, {'cui': 'C0206681', 'cui_str': 'Clear cell adenocarcinoma'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",180.0,0.0220883,"The expression levels of PD-1 and PD-L1 in EOC tissues are higher than those in adjacent tissues, especially in serous carcinomas.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ju', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gao', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'P X', 'Initials': 'PX', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Kang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'H Z', 'Initials': 'HZ', 'LastName': 'Zhao', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Qi', 'Affiliation': 'Department of Pathology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'Q P', 'Initials': 'QP', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'F D', 'Initials': 'FD', 'LastName': 'Kong', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Guan', 'Affiliation': 'Department of Pathology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian 116011, China.'}]",Zhonghua fu chan ke za zhi,['10.3760/cma.j.cn112141-20200301-00155']
2217,32894702,Development and Validation of a Clinical Score for Predicting the Risk of Tympanosclerosis Before Surgery.,"OBJECTIVE


To develop and validate a clinical score to predict the risk of tympanosclerosis before surgery.
METHODS


A sample of 404 patients who underwent middle ear microsurgery for otitis media was enrolled. These patients were randomly divided into 2 cohorts: the training cohort (n = 243, 60%) and the validation cohort (n = 161, 40%). The preoperative predictors of tympanosclerosis were determined by multivariate logistic regression analysis and implemented using a clinical score tool. The predictive accuracy and discriminative ability of the clinical score were determined by the area under the curve (AUC) and the calibration curve.
RESULTS


The multivariate analysis in the training cohort (n = 243, 60%) identified independent factors for tympanosclerosis as the female sex (odds ratio [OR]: 3.83; 95% CI: 1.66-9.37), the frequency-specific air-bone gap at 250 Hz ≥ 45 dB HL (OR: 3.68; 95% CI: 1.68-8.57), aditus ad antrum blockage (OR: 3.29; 95% CI: 1.38-8.43), type I eardrum calcification (OR: 25.37; 95% CI: 8.41-88.91) or type II eardrum calcification (OR: 18.86; 95% CI: 6.89-58.77), and a history of otitis media ≥ 10 years (OR: 4.10; 95% CI: 1.58-11.83), which were all included in the clinical score tool. The AUC of the clinical score for predicting tympanosclerosis was 0.89 (95% CI: 0.85-0.93) in the training cohort and 0.89 (95% CI: 0.84-0.95) in the validation cohort. The calibration curve also showed good agreement between the predicted and observed probability.
CONCLUSIONS


The clinical score achieved an optimal prediction of tympanosclerosis before surgery. The presence of calcification pearls on the promontorium tympani is a strong predictor of tympanosclerosis with stapes fixation.",2020,The AUC of the clinical score for predicting tympanosclerosis was 0.89 (95% CI: 0.85-0.93) in the training cohort and 0.89 (95% CI: 0.84-0.95) in the validation cohort.,['404 patients who underwent middle ear microsurgery for otitis media was enrolled'],[],"['frequency-specific air-bone gap at 250 Hz', 'history of otitis media', 'aditus ad antrum blockage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0029882', 'cui_str': 'Otitis media'}]",[],"[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1998312', 'cui_str': 'History of otitis media'}, {'cui': 'C0034193', 'cui_str': 'Pyloric antrum structure'}]",404.0,0.0737116,The AUC of the clinical score for predicting tympanosclerosis was 0.89 (95% CI: 0.85-0.93) in the training cohort and 0.89 (95% CI: 0.84-0.95) in the validation cohort.,"[{'ForeName': 'Zhihuai', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sir Run Run Shaw Hospital, 56660Medical College of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Mingguang', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sir Run Run Shaw Hospital, 56660Medical College of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Gaofei', 'Initials': 'G', 'LastName': 'Ye', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sir Run Run Shaw Hospital, 56660Medical College of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sir Run Run Shaw Hospital, 56660Medical College of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Mang', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Sir Run Run Shaw Hospital, 56660Medical College of Zhejiang University, Hangzhou, China.'}]","Ear, nose, & throat journal",['10.1177/0145561320951676']
2218,32894793,A multicenter prospective study for overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy (FAVOR study).,"AIM


We investigated the satisfaction and efficacy of mirabegron in patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment.
METHODS


This was a 12-week, open-label study of adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics. All enrolled patients have received mirabegron 50 mg once daily for 12 weeks. The primary outcome was the percentage of patients reporting treatment satisfaction questions (TSQ) at week 12 (""very satisfied"" or ""somewhat satisfied""). Patients completed voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA) at baseline, Week 4, and Week 12. At 12-weeks, patients were assessed for willingness to continue treatment.
RESULTS


The response rate of treatment satisfaction at 12 weeks was 69.3% (275/397) (95% confidence interval 64.7-73.8). Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001). Both OAB-q-SF and OABSS were significantly improved compared to baseline. At 4 and 12 weeks, 27.5% and 41.8% of patients, respectively, responded to the GRA as being moderately or markedly improved. At 12 weeks, 80.8% of patients were willing to continue mirabegron.
CONCLUSIONS


Mirabegron improved the rates of treatment satisfaction and symptoms in patients with OAB who were unsatisfied with prior antimuscarinic treatment.",2020,"Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001).","['patients with overactive bladder (OAB) symptoms who were unsatisfied with previous antimuscarinic treatment', 'adults with OAB who had been treated with antimuscarinics within 2 years of screening and expressed dissatisfaction over poor efficacy or adverse events of antimuscarinics', 'patients with OAB who were unsatisfied with prior antimuscarinic treatment', 'overactive bladder patient treatment satisfaction with mirabegron after being unsatisfied with antimuscarinic therapy\xa0(FAVOR study']",['mirabegron'],"['rates of treatment satisfaction and symptoms', 'response rate of treatment satisfaction', 'OAB-q-SF and OABSS', 'voiding diaries, Overactive Bladder Questionnaire short form (OAB-q-SF), Overactive Bladder Symptom Score (OABSS), and the global response assessment (GRA', 'frequency, urgency due to urinary incontinence, and urgency episodes', 'percentage of patients reporting treatment satisfaction questions (TSQ', 'satisfaction and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2983812', 'cui_str': 'mirabegron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2983812', 'cui_str': 'mirabegron'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0680329,"Significant improvements from baseline to weeks 4 and 12 were observed in the frequency, urgency due to urinary incontinence, and urgency episodes per 24 h (all p < .0001).","[{'ForeName': 'Kwang Jin', 'Initials': 'KJ', 'LastName': 'Ko', 'Affiliation': 'Department of Urology,\xa0Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology,\xa0Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young-Seop', 'Initials': 'YS', 'LastName': 'Chang', 'Affiliation': 'Department of Urology, Konyang University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Urology I College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology,\xa0Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Neurourology and urodynamics,['10.1002/nau.24505']
2219,32894809,Effect of hypertriglyceridemia in dyslipidemia-induced impaired glucose tolerance and sex differences in dietary features associated with hypertriglyceridemia among the Japanese population: The Gifu Diabetes Study.,"AIMS/INTRODUCTION


The mechanisms underlying hypertriglyceridemia-induced impaired glucose tolerance in Japanese remain unclear. We aimed to evaluate the effect of hypertriglyceridemia on glucose metabolism in comparison with that of increased low-density lipoprotein (LDL) or decreased high-density lipoprotein (HDL) levels and to elucidate the sex differences in hypertriglyceridemia-related dietary intake among the Japanese.
MATERIALS AND METHODS


We randomly selected 898 (384 men and 514 women) participants aged 40-78 years in the Gifu Diabetes Study; those with medication for dyslipidemia or diabetes mellitus were excluded. Serum levels of glucose metabolism parameters and the food frequency were measured cross sectionally. The glycated hemoglobin (HbA1c) was measured again after 5 years.
RESULTS


Glucose metabolism parameters and the percentage of individuals with impaired glucose tolerance was significantly higher in high triglyceride (TG) group in men and women. Similar trends were observed in low HDL group, but only in men. Meanwhile, only the homeostasis model assessment-insulin resistance was higher in high LDL group. In non-obese men, the percentage of energy intake from alcohol per total daily energy intake was significantly greater in high TG group. In obese women, total energy intake was significantly greater in high TG group. At the 5-year follow-up, the risk of elevated HbA1c levels with hypertriglyceridemia was increased in men.
CONCLUSIONS


Hypertriglyceridemia is a stronger risk factor for impaired glucose tolerance than increased LDL or decreased HDL. For dietary habits, increased daily alcohol energy intake in non-obese men and increased total energy intake in obese women were associated with hypertriglyceridemia.",2020,"RESULTS


Glucose metabolism parameters and the percentage of individuals with impaired glucose tolerance was significantly higher in high triglyceride (TG) group in men and women.","['obese women', 'We randomly selected 898 (384 men and 514 women) participants aged 40-78 years in the Gifu Diabetes Study; those with medication for dyslipidemia or diabetes mellitus were excluded', 'non-obese men', 'Japanese population']","['hypertriglyceridemia', 'triglyceride (TG']","['total energy intake', 'homeostasis model assessment-insulin resistance', 'density lipoprotein (HDL) levels', 'percentage of energy intake from alcohol per total daily energy intake', 'hypertriglyceridemia', 'percentage of individuals with impaired glucose tolerance', 'Serum levels of glucose metabolism parameters and the food frequency', 'glycated hemoglobin (HbA1c', 'daily alcohol energy intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",898.0,0.0432657,"RESULTS


Glucose metabolism parameters and the percentage of individuals with impaired glucose tolerance was significantly higher in high triglyceride (TG) group in men and women.","[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nonoyama', 'Affiliation': 'Department of Endocrinology and Metabolism, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Health Administration Center, and United Graduate School of Drug Discovery and Medical Information Sciences, Gifu University, 1-1 Yanagido, Gifu, 501-1193, Japan.'}, {'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Oba', 'Affiliation': 'Graduate School of Health Sciences, Gumma University, 3-39-22 Showa-machi, Maebashi, 371-8514, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Horikawa', 'Affiliation': 'Department of Endocrinology and Metabolism, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Nagata', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yabe', 'Affiliation': 'Department of Endocrinology and Metabolism, Gifu University Graduate School of Medicine, 1-1 Yanagido, Gifu, 501-1194, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Takeda', 'Affiliation': 'Takeda hospital, Kyoto, 600-8558, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes investigation,['10.1111/jdi.13398']
2220,32894813,The impact of surgical learning curve on survival - reopening the door for minimally invasive surgery in the management of cervical cancer?,"Minimally invasive surgery has been widely adopted in gynaecologic oncology with a significant surge the past decade associated with the introduction of robot-assisted surgery. Up until 2018, virtually all testimonials of minimally invasive surgery for cervical cancer indicated equal oncologic outcomes compared to laparotomy. The unexpected results from the only randomised controlled trial (Ramirez PT et al, N Engl J Med, 2018;379:1895-1904) seriously challenge the use of minimally invasive surgery for cervical cancer.",2020,"Up until 2018, virtually all testimonials of minimally invasive surgery for cervical cancer indicated equal oncologic outcomes compared to laparotomy.",[],"['minimally invasive surgery', 'surgical learning curve']",[],[],"[{'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",[],,0.0325115,"Up until 2018, virtually all testimonials of minimally invasive surgery for cervical cancer indicated equal oncologic outcomes compared to laparotomy.","[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Falconer', 'Affiliation': 'Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16485']
2221,32894857,Use of Azithromycin for the Prevention of Lung Injury in Mechanically Ventilated Preterm Neonates: A Randomized Controlled Trial.,"INTRODUCTION


Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities.
OBJECTIVE


The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates.
METHODS


This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for Ureaplasma. Patients were followed up throughout the hospital stay for the outcomes of death and broncho-pulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703).
RESULTS


Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood.
CONCLUSIONS


Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O2 dependency at 28 days/death in mechanically ventilated preterm neonates.",2020,"There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood.
","['Mechanically Ventilated Preterm Neonates', 'mechanically ventilated preterm neonates', 'preterm neonates who received invasive MV within 72 h of birth', 'very-low-birth-weight preterm neonates']","['Azithromycin', 'placebo', 'intravenous azithromycin', 'azithromycin']","['incidence of death and O2 dependency', 'serum IL-2 and IL-8 levels', 'mechanical ventilation (MV)-induced lung injury', 'death and O2 dependency', 'death and broncho-pulmonary dysplasia defined as need for oxygen']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0345170', 'cui_str': 'Dysplasia of lung'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",40.0,0.683944,"There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood.
","[{'ForeName': 'Cristiane R', 'Initials': 'CR', 'LastName': 'Nunes', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Renato S', 'Initials': 'RS', 'LastName': 'Procianoy', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Andréa L', 'Initials': 'AL', 'LastName': 'Corso', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Rita C', 'Initials': 'RC', 'LastName': 'Silveira', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil, drarita.c.s@gmail.com.'}]",Neonatology,['10.1159/000509462']
2222,32894871,Umbilical Cord Milking in Extremely Preterm Infants: A Randomized Controlled Trial Comparing Cord Milking with Immediate Cord Clamping.,"OBJECTIVE


This study aimed to assess potential benefits of umbilical cord milking (UCM) when compared with immediate cord clamping (ICC) in extremely preterm infants.
STUDY DESIGN


This is a single-center, randomized controlled trial of infants 24 0/7  to 27 6/7  weeks' gestation who received UCM versus ICC. In the experimental group, 18 cm of the umbilical cord was milked three times. The primary aim was to assess the initial hemoglobin and to assess the number of blood transfusions received in the first 28 days after birth. Secondary outcomes were also assessed, including intraventricular hemorrhage (IVH). A priori, neurodevelopmental follow-up was planned at 15 to 18 months corrected gestational age (CGA).
RESULTS


Baseline characteristics for 56 enrolled infants were similar in both groups with a mean gestational age of 26.1 ± 1.2 weeks and a mean birth weight of 815 ± 204 g. There were no differences in the mean initial hemoglobin in the UCM group when compared with the ICC group, 13.7 ± 2.0 and 13.8 ± 2.6 g/dL, respectively ( p  = 0.95), with no differences in median number of blood transfusions after birth between the ICC group and the UCM group, 2 (interquartile range [IQR]: 1-4) versus 2.5 (IQR: 1-5) ( p  = 0.40). There was also no difference in the rate of severe IVH. At 15 to 18 months CGA, there were no differences in death or disability in the ICC group compared with the UCM group (26 vs. 22%;  p  = 1.0) and no differences in neurodevelopmental outcomes.
CONCLUSION


In a randomized trial of ICC versus UCM in extremely preterm infants, no differences were seen in initial hemoglobin or number of blood transfusions.
KEY POINTS


· Umbilical cord milking may be an alternative to delayed cord clamping, but its safety and efficacy are not established in extremely premature infants.. · There are minimal available published data on the longer term neurodevelopmental outcomes in extremely premature infants who receive umbilical cord milking compared with immediate clamping.. · We did not find a significant difference in the primary outcomes of initial hemoglobin and blood transfusions between the groups, nor did we find a difference in severe IVH with umbilical cord milking..",2020,"At 15 to 18 months CGA, there were no differences in death or disability in the ICC group compared with the UCM group (26 vs. 22%;  p  = 1.0) and no differences in neurodevelopmental outcomes.
","['extremely premature infants', 'extremely preterm infants', ""infants 24 0/7  to 27 6/7  weeks' gestation who received"", 'Extremely Preterm Infants', '56 enrolled infants were similar in both groups with a mean gestational age of 26.1\u2009±\u20091.2 weeks and a mean birth weight of 815\u2009±\u2009204\u2009g']","['UCM', 'immediate cord clamping (ICC', 'ICC', 'UCM versus ICC', 'Cord Milking with Immediate Cord Clamping', 'umbilical cord milking (UCM']","['median number of blood transfusions', 'severe IVH with umbilical cord milking', 'mean initial hemoglobin', 'Umbilical Cord Milking', 'initial hemoglobin', 'neurodevelopmental outcomes', 'number of blood transfusions', 'death or disability', 'rate of severe IVH', 'initial hemoglobin and blood transfusions', 'initial hemoglobin or number of blood transfusions', 'intraventricular hemorrhage (IVH']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}]",56.0,0.300976,"At 15 to 18 months CGA, there were no differences in death or disability in the ICC group compared with the UCM group (26 vs. 22%;  p  = 1.0) and no differences in neurodevelopmental outcomes.
","[{'ForeName': 'Justin B', 'Initials': 'JB', 'LastName': 'Josephsen', 'Affiliation': 'Department of Pediatrics, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': ""Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University, St. Louis, Missouri.""}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Armbrecht', 'Affiliation': 'Saint Louis University Center for Outcomes Research, Saint Louis University, St. Louis, Missouri.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Al-Hosni', 'Affiliation': 'Department of Pediatrics, Saint Louis University, St. Louis, Missouri.'}]",American journal of perinatology,['10.1055/s-0040-1716484']
2223,32894894,A comparative study of five plateletpheresis machines in a tertiary care center of India: AmiCORE vs COM.TEC vs Haemonetics MCS+ vs Spectra Optia vs Trima Accel.,"BACKGROUND


Single donor apheresis platelets are superior in quality, but their usage is limited in a developing country due to cost and time constraints. Hence the product obtained must exceed in terms of yield, donor safety and technical convenience. Previous literature available on cell separators is on older versions.
AIMS


Prospective comparison of 5 latest cell separators (AmiCORE, COM.TEC, Haemonetics MCS+, SpectraOptia and TrimaAccel) for product yield, performance variables and donor adverse effects.
MATERIAL & METHODS


From October 2019 - March 2020, 1108 donors were randomly allotted to a cell separator. Post-donation sample was taken from the donor 15-20 minutes after procedure completion. The platelet yield from the product collected was measured twice (day 0 and day 1). Donor demography, pre-and post-procedural donor peripheral blood values, performance and product variables were statistically analyzed.
RESULTS


AmiCORE had an optimal collection efficacy (44.6%) and collection rate (0.037 x 1011/minute). Haemonetics MCS+ had a better collection efficacy (48.4%) and rate (0.038 x 1011/minute). Spectra Optia achieved least procedural time (59.5 minutes), donor adverse effects (6.3%); highest collection efficacy (52.8%) and rate (0.056 x 1011/minute). Trima Accel achieved highest collection rate (0.056 x 1011/minute) and the least product volume (228 ml).
CONCLUSION


Highest collection efficacy was achieved by Trima Accel, highest collection rate by Trima Accel and Spectra Optia, lowest donor adverse effects by Spectra Optia and least number of procedural troubleshooting by COM.TEC. Apart from this, fiscal factors and service availability also need to be considered before choosing a cell separator.",2020,Haemonetics MCS+ had a better collection efficacy (48.4%) and rate (0.038 x 1011/minute).,"['From October 2019 - March 2020, 1108 donors', 'five plateletpheresis machines in a tertiary care center of India']",[],"['collection rate', 'donor adverse effects', 'Spectra Optia achieved least procedural time', 'Donor demography, pre-and post-procedural donor peripheral blood values, performance and product variables', 'collection efficacy', 'highest collection rate']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0032202', 'cui_str': 'Plateletpheresis'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021201', 'cui_str': 'India'}]",[],"[{'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205250', 'cui_str': 'High'}]",1108.0,0.0407889,Haemonetics MCS+ had a better collection efficacy (48.4%) and rate (0.038 x 1011/minute).,"[{'ForeName': 'Priyadarsini Jayachandran', 'Initials': 'PJ', 'LastName': 'Arcot', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Coshic', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Andriyas', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Mehta', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of clinical apheresis,['10.1002/jca.21838']
2224,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND


Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS


Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS


There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION


Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
2225,32898578,Family Integrated Care for Preterm Infants in China: A Cluster Randomized Controlled Trial.,"OBJECTIVE


To explore whether Family Integrated Care (FICare) is feasible and improves the outcomes of preterm infants in China.
STUDY DESIGN


This was a multicenter prospective cluster-randomized controlled trial comparing FICare and standard care. Primary outcome was length of stay (LOS). Secondary outcomes were nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain. Outcomes were compared using univariate and multivariable analyses adjusted for potential confounders and clustering.
RESULTS


We enrolled 601 preterm infants from 11 neonatal intensive care units (FICare, n=298; control, n=303). Unadjusted LOS was 30.81 vs 30.26 days (mean ratio 1.02, 95% CI 0.85-1.22; P = .85). After adjustment, outcomes in the FICare group were improved compared with the control group, including: LOS (28.26 vs 35.04 days; mean ratio 0.81, 95% CI 0.72-0.91), total medical expenditures (mean ratio 0.69, 95% CI 0.53-0.90), weight gain velocity (15.73 vs 10.30 g/day; mean difference 5.43, 95% CI 3.65-7.21), duration of supplemental oxygen (13.11 vs 21.42 days; mean difference 0.71, 95% CI 0.50-1.00), nosocomial infection rates (4.13 vs 5.84/1000 hospital days; mean ratio 0.67, 95% CI 0.47-0.96), antibiotic exposure (38.63 vs 57.32/100 hospital days; mean ratio 0.67, 95% CI 0.47-0.96), breastfeeding rates (87.25% vs 55.78%; OR 5.42, 95% CI 3.25-9.05), and re-hospitalization rates (3.65% vs 7.48%; OR 0.47, 95% CI 0.28-0.77). At follow-up to 18 months, breastfeeding rates and weight were significantly (p<0.05) higher over time in the FICare group.
CONCLUSIONS


FICare was feasible in Chinese neonatal intensive care units and reduced the duration of hospitalization, medical expenditures and rates of adverse outcomes.",2020,"At follow-up to 18 months, breastfeeding rates and weight were significantly (p<0.05) higher over time in the FICare group.
","['preterm infants in China', '601 preterm infants from 11 neonatal intensive care units (FICare, n=298; control, n=303', 'Preterm Infants in China']","['Family Integrated Care (FICare', 'FICare and standard care']","['nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain', 'length of stay (LOS', 'antibiotic exposure', 'Unadjusted LOS', 'breastfeeding rates and weight', 're-hospitalization rates', 'duration of hospitalization, medical expenditures and rates of adverse outcomes', 'total medical expenditures', 'nosocomial infection rates', 'weight gain velocity', 'LOS', 'duration of supplemental oxygen', 'breastfeeding rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",601.0,0.312111,"At follow-up to 18 months, breastfeeding rates and weight were significantly (p<0.05) higher over time in the FICare group.
","[{'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Hei', 'Affiliation': ""Neonatal Center, Beijing Children's Hospital, Capital Medical University, Beijing, China; National Center of Children's Heath, China. Electronic address: heimingyan@bch.com.cn.""}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatrics, Southeast University Affiliated Xuzhou Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, the Third Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Neonatology, Hunan Children's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Zhankui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Northwest Women and Children's Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Department of Neonatology, Hubei Province Women and Children Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Qianshen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Shenzhen Maternal and Childcare Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Depatment of Neonatology, Nanjing Maternity and Child Health Care Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, Gansu Provincial Maternity and Childcare Hospital, Lanzhou, Gansu, China.'}, {'ForeName': 'Shaohan', 'Initials': 'S', 'LastName': 'Nong', 'Affiliation': ""Department of Pediatrics, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China.""}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neonatology, Kunming Maternal and Child Healthcare Hospital, Kunming, Yunnan, China.'}, {'ForeName': 'Yanchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Chinese Neonatal Network (CHNN), Fudan Children's Hospital, Shanghai, China.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-infant Care Research Centre, Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Shoo K', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Maternal-infant Care Research Centre, Mount Sinai Hospital, Toronto, ON, Canada; Department of Pediatrics, Mount Sinai Hospital, Toronto, ON, Canada; Department of Pediatrics, University of Toronto Faculty of Medicine, Toronto, ON, Canada.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.006']
2226,32898690,A nomogram from the SEER database for predicting the prognosis of patients with non-small cell lung cancer.,"OBJECTIVE


The purpose of this study was to establish and validate a nomogram to predict the prognosis in patients with non-small cell lung cancer (NSCLC) from multiple perspectives.
RESULTS


A total of 98,640 eligible patients were randomly divided into a training set (n = 69,048) and a validation set (n = 29,592). The baseline characteristics of the two sets were similar. We used clinical data from patients in the training set for univariate and multivariate Cox regression analyses. Twelve independent risk factors were incorporated for constructed a prognostic nomogram. And the nomogram with a concordance index of 0.777 (95% CI, 0.775 to 0.779) for overall survival. The calibration curve results showed that the actual survival rate was consistent with the predicted survival rate. The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
CONCLUSION


We have developed a nomogram with high prediction accuracy and discrimination ability, which can help clinicians making personalized survival predictions for NSCLC patients.",2020,"The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
","['98,640 eligible patients', 'NSCLC patients', 'patients with NSCLC', 'patients with non-small cell lung cancer (NSCLC', 'patients with non-small cell lung cancer']",[],"['overall survival rate', 'survival rate', 'actual survival rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]",[],"[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",98640.0,0.0901438,"The area under curve of the receiver operating characteristic curves demonstrated that the nomogram has a high prediction of the overall survival rate in patients with NSCLC.
","[{'ForeName': 'Bingjie', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ji', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junjun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Chenzheng', 'Initials': 'C', 'LastName': 'Gu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Anquan', 'Initials': 'A', 'LastName': 'Shang', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Junlu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China.'}, {'ForeName': 'Zujun', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China. Electronic address: sunzujun@tongji.edu.cn.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Clinical Laboratory, Shanghai Tongji Hospital, Tongji University School of Medicine, No. 389, Xincun Road, Shanghai, 200065, China. Electronic address: lidong@tongji.edu.cn.'}]",The international journal of biochemistry & cell biology,['10.1016/j.biocel.2020.105825']
2227,32898698,The Benefit of adding Lidocaine to Ketamine during Rapid Sequence Endotracheal Intubation in Patients with Septic Shock: A Randomised Controlled Trial.,"BACKGROUND


Patients with septic shock commonly require endotracheal intubation under general anaesthesia in the operating theatre, the emergency department, and the intensive care unit. Hypotension is a serious complication after induction of general anaesthesia especially in patients with circulatory failure. No randomised controlled trials had previously investigated protocols for induction of anaesthesia in septic shock patients. The aim of the current work is to compare two protocols, lidocaine-ketamine combination versus ketamine full-dose for rapid-sequence endotracheal intubation in patients with septic shock.
METHODS


Forty-four adult patients, with septic shock, scheduled for emergency surgical intervention were enrolled in this randomised, double-blinded, controlled study. Patients were randomised to receive either 1 mg/kg ketamine (ketamine group, n = 22) or 0.5 mg/kg ketamine plus 1 mg/kg lidocaine (ketamine-lidocaine group, n = 22) for induction of anaesthesia in addition to 0.05 mg/kg midazolam (in both groups). Our primary outcome was the mean arterial pressure (MAP). Other outcomes included frequency of post-induction hypotension, heart rate, and cardiac output.
RESULTS


Forty-three patients were available for final analysis. The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}. Furthermore, the incidence of post-intubation hypotension was lower in the ketamine-lidocaine group than in the ketamine group {1 patient (5%) versus 17 patients (77%), P < 0.001}. The ketamine-lidocaine group showed higher MAP in almost all the readings after induction compared to ketamine group. Other haemodynamic variables including cardiac output and heart rate were comparable between both study groups.
CONCLUSION


Lidocaine-ketamine combination showed less incidence of hypotension compared to ketamine full-dose when used for rapid-sequence endotracheal intubation in patients with septic shock. REGISTRATION URL: : https://clinicaltrials.gov/ct2/show/NCT03844984?cond=NCT03844984&rank=1.",2020,"The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}.","['patients with septic shock', 'Patients with septic shock commonly require', 'patients with circulatory failure', 'septic shock patients', 'Forty-four adult patients, with septic shock, scheduled for emergency surgical intervention', 'Patients with Septic Shock']","['ketamine (ketamine group, n\u2009=\u200922) or 0.5\u2009mg/kg ketamine plus 1\u2009mg/kg lidocaine (ketamine-lidocaine group, n\u2009=\u200922) for induction of anaesthesia in addition to 0.05\u2009mg/kg midazolam', 'Ketamine', 'endotracheal intubation', 'ketamine', 'Lidocaine-ketamine', 'lidocaine-ketamine combination versus ketamine', 'ketamine-lidocaine', 'Lidocaine']","['incidence of hypotension', 'mean arterial pressure (MAP', 'cardiac output and heart rate', 'incidence of post-intubation hypotension', 'average MAP reading', 'frequency of post-induction hypotension, heart rate, and cardiac output', 'MAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",44.0,0.561023,"The average MAP reading in the first 5 minutes post-induction was higher in ketamine-lidocaine group than in the ketamine group {82.8 ± 5.6 mmHg and 73 ± 10.2 mmHg, P < 0.001}.","[{'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Fathy', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt. Electronic address: ahmed.hasanin@kasralainy.edu.eg.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ezzat', 'Initials': 'E', 'LastName': 'Ramzy', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Sarhan', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Almenesey', 'Affiliation': 'Department of anaesthesia and critical care medicine, Beni Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Safina', 'Affiliation': 'Department of general surgery, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hosny', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ghada Adel', 'Initials': 'GA', 'LastName': 'Hamden', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Gado', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mokhtar', 'Affiliation': 'Department of anaesthesia and critical care medicine, Cairo University, Cairo, Egypt.'}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.017']
2228,32898699,N-Glycome changes reflecting resistance to platinum-based chemotherapy in ovarian cancer.,"A number of studies have reported aberrant glycosylation in connection with malignancy. Our investigation further expands on this topic through the examination of N-glycans, which could be associated with the resistance of advanced stage, high-grade non-mucinous ovarian cancer to platinum/taxane based chemotherapy. We used tissue samples of 83 ovarian cancer patients, randomly divided into two independent cohorts (basic and validation). Both groups involved either cases with/without postoperative tumor residue or the cases determined either resistant or sensitive to this chemotherapy. In the validation cohort, preoperative serum samples were also available. N-glycans released from tumors and sera were permethylated and analyzed by matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS). The MS analysis yielded a consecutive detection of 68 (tissue) and 63 (serum) N-glycan spectral signals. Eight of these were found to be differentially abundant in tissues of both independent cohorts including the cases with a postoperative cancer residue. One of these glycans was detected as differentially abundant in sera of the validation cohort. No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort. From the biochemical point of view, the statistically significant N-glycans correspond to the structures carrying bisecting (terminal) GlcNAc residue and tetra-antennary structures with sialic acid and/or fucose residues. Among them, five tissue N-glycans could be considered potential markers connected with a resistance to chemotherapy in ovarian cancer patients. The prediction of primary resistance to standard chemotherapy may identify the group of patients suitable for alternative treatment strategies. SIGNIFICANCE: Drug resistance has become a major impediment to a successful treatment of patients with advanced ovarian cancer. The glycomic measurements related to cancer are becoming increasingly popular in identification of the key molecules as potential diagnostic and prognostic indicators. Our report deals with identification of differences in N-glycosylation of proteins of tissue and sera samples from the individuals showing sensitivity or resistance to platinum/taxane-based chemotherapy. The detection sensitivity to chemotherapy is vitally important for these patients.",2020,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"['patients with advanced ovarian cancer', 'ovarian cancer', '83 ovarian cancer patients', 'ovarian cancer patients']","['platinum/taxane-based chemotherapy', 'platinum-based chemotherapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]",[],83.0,0.0192624,No statistically significant differences in intensities due to the same N-glycans were found in the cases without postoperative macroscopic residues in either the basic or validation cohort.,"[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zahradnikova', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Ihnatova', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Recetox, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Lattova', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Uhrik', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Eliska', 'Initials': 'E', 'LastName': 'Stuchlikova', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Nenutil', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Valik', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Nalezinska', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Chovanec', 'Affiliation': 'Department of Gynecologic Oncology, Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Zbynek', 'Initials': 'Z', 'LastName': 'Zdrahal', 'Affiliation': 'Central European Institute of Technology, Masaryk University, Kamenice 753/5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Borivoj', 'Initials': 'B', 'LastName': 'Vojtesek', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Hernychova', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic. Electronic address: lenka.hernychova@mou.cz.'}, {'ForeName': 'Milos V', 'Initials': 'MV', 'LastName': 'Novotny', 'Affiliation': 'Regional Centre for Applied Molecular Oncology, Masaryk Memorial Cancer Institute, Zluty kopec7, 656 53 Brno, Czech Republic; Department of Chemistry, Indiana University, 800 E. Kirkwood Avenue, Bloomington, IN 47405, USA. Electronic address: novotny@indiana.edu.'}]",Journal of proteomics,['10.1016/j.jprot.2020.103964']
2229,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND


Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS


This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9  CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS


A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION


Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
2230,32898792,Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial.,"PURPOSE


Maintenance chemotherapy is a reasonable choice for patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.
PATIENTS AND METHODS


We conducted a randomised trial in patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m 2  d1, 22) in patients with non-squamous cell carcinoma or gemcitabine (1,150 mg/m 2  d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
RESULTS


632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0-17.0) in the observation arm and 14 months (95% CI: 10.9-16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
CONCLUSION


Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.",2020,"The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
","['elderly patients with advanced non-small cell lung cancer', 'elderly patients', 'patients were required to have a performance status (PS) 0-2, mini-mental score >23, and creatinine clearance ≥45', 'patients aged 70-89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500\xa0mg/m 2  d1, 22) in patients with non-squamous cell carcinoma or', 'elderly patients with advanced NSCLC', '632 patients were enrolled from May 2013 to October 2016', 'patients with metastatic non-small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet', 'Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received']","['pemetrexed and 43 gemcitabine', 'Maintenance chemotherapy', 'gemcitabine', 'carboplatin and weekly paclitaxel doublet chemotherapy']","['median progression-free survival (PFS', 'median OS', 'overall survival (OS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1545484', 'cui_str': 'Non-squamous epithelial cell'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",632.0,0.168415,"The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6-3.1) in the observation arm versus 5.7 months (95% CI: 4.8-7.1) in the maintenance arm (p < 0.001).
","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Quoix', 'Affiliation': 'Department of Pneumology, University Hospital of Strasbourg, Strasbourg, France. Electronic address: equoix@gmail.com.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Pneumology, Toulon Sainte-Musse Hospital, Toulon, France.'}, {'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Lavolé', 'Affiliation': 'Department of Pneumology, Tenon Hospital, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Department of Pneumology, Hospital of Le Mans, Le Mans, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Westeel', 'Affiliation': 'Department of Pneumology, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Le Treut', 'Affiliation': ""Department of Pneumology, Pays D'Aix Hospital, Aix-en-Provence, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Department of Pneumology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Dauba', 'Affiliation': 'Department of Medical Oncology, Hospital Layné, Mont-de-Marsan, France.'}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': ""University of Côte D'Azur, Nice, France.""}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Moreau', 'Affiliation': 'Department of Pneumology, Louis Pasteur Hospital, Colmar, France.'}, {'ForeName': 'Jeannick', 'Initials': 'J', 'LastName': 'Madelaine', 'Affiliation': 'Department of Pneumology, University Hospital of Caen Normandie, Caen, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dumont', 'Affiliation': 'Department of Pneumology, Hospital of Chauny, Chauny, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Margery', 'Affiliation': ""Department of Pneumology, Hôpital D'Instruction des Armées Percy, Clamart, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Debieuvre', 'Affiliation': 'Department of Pneumology, GHRMSA, Emile Miller Hospital, Mulhouse, France.'}, {'ForeName': 'Patrick Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Department of Pneumology, Hospital of Pau, Pau, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pujol', 'Affiliation': 'Department of Thoracic Oncology, Montpellier Regional University Hospital, Montpellier, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Thoracic Oncology Unit, Grenoble-Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Department of Pneumology and Thoracic Oncology, Hospital of Lyon Sud, Lyon, France.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.034']
2231,32898839,Pediatrics adverse childhood experiences and related life events screener (PEARLS) and health in a safety-net practice.,"BACKGROUND


Adverse Childhood Experiences (ACEs) are associated with behavioral, mental, and clinical outcomes in children. Tools that are easy to incorporate into pediatric practice, effectively screen for adversities, and identify children at high risk for poor outcomes are lacking.
OBJECTIVE


To examine the relationship between caregiver-reported child ACEs and related life events with health outcomes.
PARTICIPANTS AND SETTING


Participants (0-11 years) were recruited from the University of California San Francisco Benioff's Children Hospital Oakland Primary Care Clinic. There were 367 participants randomized.
METHODS


Participants were randomized 1:1:1 to item-level (item response), aggregate-level (total number of exposures), or no screening for ACEs (control arm) with the PEdiatric ACEs and Related Life Event Screener (PEARLS). We assessed 10 ACE categories capturing abuse, neglect, and household challenges, as well as 7 additional categories. Multivariable regression models were conducted.
RESULTS


Participants reported a median of 2 (IQR 1-5) adversities with 76 % (n = 279) reporting at least one adversity; participants in the aggregate-level screening arm, on average, disclosed 1 additional adversity compared to item-level screening (p = 0.01). Higher PEARLS scores were associated with poorer perceived child general health (adjusted B = -0.94, 95 %CI: -1.26, -0.62) and Global Executive Functioning (adjusted B = 1.99, 95 %CI: 1.51, 2.46), and greater odds of stomachaches (aOR 1.14; 95 %CI: 1.04-1.25) and asthma (aOR 1.08; 95 %CI 1.00, 1.17). Associations did not differ by screening arm.
CONCLUSION


In a high-risk pediatric population, ACEs and other childhood adversities remain an independent predictor of poor health. Increased efforts to screen and address early-life adversity are necessary.",2020,"Associations did not differ by screening arm.
","['children', 'Participants', '367 participants randomized', ""Participants (0-11 years) were recruited from the University of California San Francisco Benioff's Children Hospital Oakland Primary Care Clinic""]","['aggregate-level (total number of exposures), or no screening for ACEs (control arm) with the PEdiatric ACEs and Related Life Event Screener (PEARLS']","['child general health', 'Global Executive Functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]","[{'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0454267', 'cui_str': 'Number of exposures'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",367.0,0.182968,"Associations did not differ by screening arm.
","[{'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Thakur', 'Affiliation': 'University of California, San Francisco Departments of Medicine and Epidemiology and Biostatistics, 500 Parnassus Avenue, PO Box 0841, San Francisco CA, 94143-0841, United States. Electronic address: Neeta.Thakur@ucsf.edu.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hessler', 'Affiliation': 'University of California, San Francisco Department of Family and Community Medicine, 500 Parnassus Avenue, E334, Box 0900, San Francisco, CA, 94117, United States. Electronic address: Danielle.Hessler@ucsf.edu.'}, {'ForeName': 'Kadiatou', 'Initials': 'K', 'LastName': 'Koita', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: kadiatoukoita1@gmail.com.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Ye', 'Affiliation': 'University of California, San Francisco Department of Medicine. Electronic address: morganyafang.ye@ucsf.edu.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Benson', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, 747 52nd St, Oakland, CA, 94609, United States. Electronic address: Mindy.Benson@ucsf.edu.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Gilgoff', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: rgilgoff@centerforyouthwellness.org.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bucci', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: mbucci@centerforyouthwellness.org.'}, {'ForeName': 'Dayna', 'Initials': 'D', 'LastName': 'Long', 'Affiliation': ""UCSF Benioff Children's Hospital Oakland, 747 52nd St, Oakland, CA, 94609, United States; California AB 340 Work Group Member, United States. Electronic address: dayna.long@ucsf.edu.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Burke Harris', 'Affiliation': 'Center for Youth Wellness, 3450 3rd St, San Francisco, CA, 94124, United States. Electronic address: nadine.burke@gmail.com.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104685']
2232,32898855,Nudge interventions to reduce fish sauce consumption in Thailand.,"High sodium consumption is one of the four major risk factors contributing to non-communicable diseases around the world. Thailand has one of the highest rates of sodium consumption, with fish sauce being one of the main sources. The aim of this study was to examine whether changes in the micro-environment factors can affect fish sauce consumption behavior in a university setting in Thailand. We implemented four interventions (with one control) in five canteens across a Thai university. The study design was a Latin square, where the five canteens were randomized over five weeks to implement four interventions plus a control. Our interventions included behavior-oriented, cognitive-oriented, and affective-oriented nudges aimed to reduce the amount of fish sauce people add to their noodles during lunchtime at the university canteens. Results indicate that a simple change in how fish sauce was served can reduce fish sauce consumption. Serving fish sauce in a bowl with a spoon reduced the amount of fish sauce used per noodle bowl by 0.25 grams, compared to the normal condition where fish sauce is served in a bottle. Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl. The other two interventions, cognitive- and affective- oriented nudges, also showed reductions of fish sauce usage, but the differences were not statistically significant. The findings can be used for policy implementation to advocate the use of a smaller sized spoon and a bowl to serve fish sauce instead of a bottle to reduce sodium consumption among Thai people.",2020,Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl.,"['Thailand', 'a university setting in Thailand', 'Thai people']",[],['reductions of fish sauce usage'],"[{'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0453357', 'cui_str': 'Sauce'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",5.0,0.01837,Using a specially-designed spoon with a hole induced a larger reduction of 0.58 grams of fish sauce used per bowl.,"[{'ForeName': 'Manasigan', 'Initials': 'M', 'LastName': 'Kanchanachitra', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Chalermpol', 'Initials': 'C', 'LastName': 'Chamchan', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Churnrurtai', 'Initials': 'C', 'LastName': 'Kanchanachitra', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Kanyapat', 'Initials': 'K', 'LastName': 'Suttikasem', 'Affiliation': 'Institute for Population and Social Research, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gunn', 'Affiliation': 'Department of Public Health Sciences, College of Health and Human Services, University of North Carolina at Charlotte, Charlotte, North Carolina, United States of America.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Coventry, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0238642']
2233,32898921,Validation of an Instrument for Real-Time Assessment of Neonatal Intubation Skills: A Randomized Controlled Simulation Study.,"OBJECTIVE


This study aimed to evaluate the construct validity and reliability of real-time assessment of a previously developed neonatal intubation scoring instrument (NISI).
STUDY DESIGN


We performed a randomized controlled simulation study at a simulation-based research and training facility. Twenty-four clinicians experienced in neonatal intubation (""experts"") and 11 medical students (""novices"") performed two identical elective intubations on a neonatal patient simulator. Subjects were randomly assigned to either the intervention group, receiving predefined feedback between the two intubations, or the control group, receiving no feedback. Using the previously developed NISI, all intubations were assessed, both in real time and remotely on video. Construct validity was evaluated by (1) comparing the intubation performances, expressed as percentage scores, with and without feedback, and (2) correlating the intubation performances with the subjects' level of experience. The intrarater reliability, expressed as intraclass correlation coefficient (ICC), of real-time assessment compared with video-based assessment was determined.
RESULTS


The intervention group contained 18 subjects, the control group 17. Background characteristics and baseline intubation scores were comparable in both groups. The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively;  p  = 0.013). The 95% CI for this 10.2% difference was 2.2 to 21.4%. The subjects' experience level correlated significantly with their percentage scores (Spearman's  R  = 0.70;  p < 0.01). ICC's were 0.95 (95% CI: 0.89-0.97) and 0.94 (95% CI: 0.89-0.97) for the first and second intubation, respectively.
CONCLUSION


Our NISI has construct validity and is reliable for real-time assessment.
KEY POINTS


· Our neonatal intubation scoring instrument has construct validity.. · Our instrument can be reliably employed to assess neonatal intubation skills directly in real time.. · It is suitable for formative assessment, i.e., providing direct feedback during procedural training..",2020,"The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively;  p  = 0.013).","['Twenty-four clinicians experienced in neonatal intubation (""experts"") and 11 medical students (""novices"") performed two identical elective intubations on a neonatal patient simulator', 'Neonatal Intubation Skills']","['neonatal intubation scoring instrument (NISI', 'control group, receiving no feedback']","[' characteristics and baseline intubation scores', 'intraclass correlation coefficient (ICC), of real-time assessment', 'median (IQR) change in percentage scores']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.112193,"The median (IQR) change in percentage scores between the first and second intubation was significantly different between the intervention and control group (11.6% [4.7-22.8%] vs. 1.4% [0.0-5.7%], respectively;  p  = 0.013).","[{'ForeName': 'Lindie J M K', 'Initials': 'LJMK', 'LastName': 'Kuijpers', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Binkhorst', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Yamada', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Center for Advanced Pediatric and Perinatal Education (CAPE), Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Romy N', 'Initials': 'RN', 'LastName': 'Bouwmeester', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Arno F J', 'Initials': 'AFJ', 'LastName': 'van Heijst', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Halamek', 'Affiliation': 'Division of Neonatal and Developmental Medicine, Department of Pediatrics, Center for Advanced Pediatric and Perinatal Education (CAPE), Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Hogeveen', 'Affiliation': ""Department of Neonatology, Radboud University Medical Center Amalia Children's Hospital, Nijmegen, The Netherlands.""}]",American journal of perinatology,['10.1055/s-0040-1715530']
2234,32898930,Accuracy of contralateral Villalta score to assess for pre-existing chronic venous insufficiency in patients with unilateral deep vein thrombosis.,"BACKGROUND


International guidelines recommend using the Villalta score (VS) to diagnose the post-thrombotic syndrome (PTS). However, a high proportion of PTS detected with VS could just reflect the presence of pre-existing primary venous insufficiency (PVI). Furthermore, it is unclear whether the contralateral VS (cl-VS) can be used to assess for pre-existing PVI.
OBJECTIVES


To estimate whether cl-VS can be used to assess for pre-existing PVI, and to assess the proportion of PTS that could be attributable to pre-existing PVI.
METHODS


Sub-analysis of the SOX multicentre randomized trial focusing on patients with a first unilateral proximal DVT followed for up to 2 years. PVI was defined as a baseline cl-VS>4, and PTS as VS>4 in the leg ipsilateral to DVT starting 6 months after DVT.
RESULTS


Among 680 patients, mean cl-VS remained stable over time: 1.23 (SD 2.49) at baseline and 1.17(2.20), 1.59(2.81), 1.54(2.50), 1.65(2.82), 1.55(2.63) at the 1, 6, 12, 18 and 24 months visits, respectively. Baseline cl-VS and ipsilateral VS measured during follow-up were mildly correlated (Pearson correlation=0.13-0.25). This association disappeared after subtracting from the ipsilateral VS the cl-VS measured at the same visit. Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS>4.
CONCLUSION


In our study of patients with a first unilateral proximal DVT, the proportion of patients with PTS who had a cl-VS>4 is modest. However, cl-VS appears to be stable over time. Its assessment could constitute a simple way of documenting preexisting PVI and help to classify patients as having PTS or not.",2020,"Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS>4.
CONCLUSION


","['patients with unilateral deep vein thrombosis', '680 patients', 'patients with a first unilateral proximal DVT followed for up to 2 years']",[],"['Baseline cl-VS and ipsilateral VS', 'PVI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}]",680.0,0.0679659,"Overall, 48.8% of patients developed PTS of whom 12.8% had baseline cl-VS>4.
CONCLUSION


","[{'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Galanaud', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Canada.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ducruet', 'Affiliation': 'URCA-CHU Sainte Justine, Université de Montréal, Montréal, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Department of Medicine and Lady Davis Institute, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15091']
2235,32898990,Ward nurses-focused educational intervention improves the quality of bowel preparation in inpatients undergoing colonoscopy: A CONSORT-compliant randomized controlled trial.,"BACKGROUND


Adequate bowel preparation is essential for the detection of pathological lesions during colonoscopy. However, it has been found to be inadequate in approximately 20% to 30% of colonoscopy examinations. Educational interventions focused on health staff, such as physicians and nurses, may improve the patients' understanding of the bowel preparation instructions, and consequently, increase the quality of bowel preparation.
OBJECTIVES


To investigate whether enhanced education of ward nurses could improve the bowel preparation quality in inpatients undergoing colonoscopy.
DESIGN


This was a single-center randomized controlled study.
METHODS


A total of 190 consecutive inpatients scheduled to undergo colonoscopy from March 2019 to March 2020 were randomized to the educated (nurses with enhanced education) or control group (nurses without enhanced education). We assessed the bowel preparation quality using the Boston bowel preparation scale.
RESULTS


There were 89 patients in the educated group and 101 patients in the control group. The proportion of colonoscopies with adequate bowel preparation was 83.1% in the educated group and 69.3% in the control group. Patients' compliance with bowel preparation in the educated group was superior to that in the control group. Furthermore, significantly better sleep quality was found in the educated group. The multivariate logistic regression analysis identified the ward nurses-focused enhanced educational intervention as a risk factor for bowel preparation quality.
CONCLUSIONS


The ward nurses-focused educational intervention improved the bowel preparation quality and reduced the adverse event rates in inpatients undergoing colonoscopy.
TRIAL REGISTRATION


This study was registered in the Chinese Clinical Trial Registry under number ChiCTR2000030366.",2020,"The ward nurses-focused educational intervention improved the bowel preparation quality and reduced the adverse event rates in inpatients undergoing colonoscopy.
","['190 consecutive inpatients scheduled to undergo colonoscopy from March 2019 to March 2020', 'inpatients undergoing colonoscopy', '89 patients in the educated group and 101 patients in the control group']","['educated (nurses with enhanced education) or control group (nurses without enhanced education', 'educational intervention', 'Educational interventions']","['adverse event rates', 'quality of bowel preparation', 'proportion of colonoscopies with adequate bowel preparation', 'bowel preparation quality', 'sleep quality']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",190.0,0.0757321,"The ward nurses-focused educational intervention improved the bowel preparation quality and reduced the adverse event rates in inpatients undergoing colonoscopy.
","[{'ForeName': 'Aihong', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Shuhong', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Huashe', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Yijia', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Gastrointestinal Surgery.'}, {'ForeName': 'Junkui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Fu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Qining', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastrointestinal Endoscopy, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou.'}, {'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Gastrointestinal Endoscopy Center, The Eighth Affiliated Hospital, Sun Yat-sen University, Shenzhen, Guangdong, P.R. China.'}]",Medicine,['10.1097/MD.0000000000020976']
2236,32898998,Managing job stress in teachers of children with autism: A rational emotive occupational health coaching control trial.,"BACKGROUND/OBJECTIVE


Teaching has been found to be 1 of the most stressful occupations worldwide. Stress associated with teaching is more critical among teachers teaching children with special needs in general and those with autism specifically, partly due to the heterogeneous nature of the disorders. The purpose of this study was to investigate the effectiveness of Rational Emotive Occupational Health Coaching (REOHC) in minimizing job stress in teachers of children with autism (CWA).
METHODS


A group-randomized waitlist control-trial design was adopted. A sample of 87 teachers of CWA who participated in the study was randomized into the immediate intervention group (IIG) and waitlist group (WLG). Participants were evaluated on 3 occasions: pretest, post-test and follow-up. Three instruments (Occupational Stress Index, Perceived Occupational Stress Scale and Stress Symptom Scale) were used to measure dimensions of job stress. After the pretest exercise, the IIG participated in a 2-hour REOHC programme weekly for a period of 12 weeks. Post- and follow-up evaluations were conducted respectively at 2 weeks and 3 months after the REOHC programme. Those in WLG were exposed to the REOHC after the follow-up assessment. Data collected were analysed using t-test statistics, repeated measures analysis of variance and bar charts.
RESULTS


Results revealed that the perceived stress and stress symptoms of the REOHC group reduced significantly over WLG at post-test, and follow-up assessments. Changes in the occupational stress index scores across pre-, post- and follow-up measurements were minimal and could not account for a significant difference between the IIG and WLG.
CONCLUSION


It was concluded that REOHC is effective in reducing subjective feelings and physiological symptoms of job stress, even when the objective stressors remain constant among teachers of CWA and other employees who work in stressful occupational environments.",2020,"Changes in the occupational stress index scores across pre-, post- and follow-up measurements were minimal and could not account for a significant difference between the IIG and WLG.
","['A sample of 87 teachers of CWA who participated in the study', 'teachers of children with autism', 'teachers of children with autism (CWA']","['Rational Emotive Occupational Health Coaching (REOHC', 'REOHC', 'immediate intervention group (IIG) and waitlist group (WLG']","['perceived stress and stress symptoms', 'occupational stress index scores', 'instruments (Occupational Stress Index, Perceived Occupational Stress Scale and Stress Symptom Scale', 'subjective feelings and physiological symptoms of job stress']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",87.0,0.0285419,"Changes in the occupational stress index scores across pre-, post- and follow-up measurements were minimal and could not account for a significant difference between the IIG and WLG.
","[{'ForeName': 'Francisca N', 'Initials': 'FN', 'LastName': 'Ogba', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Charity N', 'Initials': 'CN', 'LastName': 'Onyishi', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Victor-Aigbodion', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Ifeanyichukwu M', 'Initials': 'IM', 'LastName': 'Abada', 'Affiliation': ''}, {'ForeName': 'Uchenna N', 'Initials': 'UN', 'LastName': 'Eze', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Patience E', 'Initials': 'PE', 'LastName': 'Obiweluozo', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Christiana N', 'Initials': 'CN', 'LastName': 'Ugodulunwa', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Ntasiobi C N', 'Initials': 'NCN', 'LastName': 'Igu', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Cornelius O', 'Initials': 'CO', 'LastName': 'Okorie', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'JeanFrance C', 'Initials': 'JC', 'LastName': 'Onu', 'Affiliation': 'School of General Studies, University of Nigeria Nsukka.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Eze', 'Affiliation': 'Department of Educational Foundations, Alex Ekwueme University, Ndufu-Alike, Ebonyi State Nigeria.'}, {'ForeName': 'Emmanuel O', 'Initials': 'EO', 'LastName': 'Ezeani', 'Affiliation': 'Department of Political Science.'}, {'ForeName': 'Elizabeth N', 'Initials': 'EN', 'LastName': 'Ebizie', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}, {'ForeName': 'Alexandra O', 'Initials': 'AO', 'LastName': 'Onwu', 'Affiliation': 'Department of Educational Foundations, University of Nigeria, Nsukka.'}]",Medicine,['10.1097/MD.0000000000021651']
2237,32899001,Dexmedetomidine for early postoperative cognitive dysfunction after video-assisted thoracoscopic lobectomy in elderly male patients with lung cancer.,"This retrospective study explored the efficacy and safety of dexmedetomidine in treating early postoperative cognitive dysfunction (EPPNCD) after video-assisted thoracoscopic lobectomy (VATL) in elderly male patients with lung cancer (LC).This study included a total of 80 elderly male patients with LC who received VATL. All of them were equally assigned to a treatment group and a control group, with 40 patients each group. The primary outcome included cognitive dysfunction, as evaluated by mini-mental state examination scale. The secondary outcomes consisted of incidence of EPPNCD, lung function (as measured by forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, and maximal voluntary ventilation), and adverse events. All outcome data were analyzed before and 3 days after surgery.After surgery, all patients in the treatment group exerted better efficacy in mini-mental state examination scale (P < .01) and incidence of EPPNCD (P = .03), than patients in the control group. However, no significant differences were detected in forced vital capacity (P = .65), forced expiratory volume in 1 second (P = .50), peak expiratory flow (P = .73), and maximal voluntary ventilation (P = .27) between 2 groups. In addition, there is similar safety profile between 2 groups.The findings of this study showed that dexmedetomidine may benefit EPPNCD after VATL in elderly male patients with LC. Future studies are needed to warrant the present conclusions.",2020,"However, no significant differences were detected in forced vital capacity (P = .65), forced expiratory volume in 1 second (P = .50), peak expiratory flow (P = .73), and maximal voluntary ventilation (P = .27) between 2 groups.","['elderly male patients with lung cancer', 'elderly male patients with lung cancer (LC).This study included a total of 80 elderly male patients with LC who received', 'elderly male patients with LC']","['video-assisted thoracoscopic lobectomy (VATL', 'VATL', 'Dexmedetomidine', 'video-assisted thoracoscopic lobectomy', 'dexmedetomidine']","['maximal voluntary ventilation', 'cognitive dysfunction, as evaluated by mini-mental state examination scale', 'efficacy and safety', 'incidence of EPPNCD, lung function (as measured by forced vital capacity, forced expiratory volume in 1 second, peak expiratory flow, and maximal voluntary ventilation), and adverse events', 'forced expiratory volume', 'forced vital capacity', 'peak expiratory flow', 'efficacy in mini-mental state examination scale', 'incidence of EPPNCD']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0024967', 'cui_str': 'Maximum voluntary ventilation'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}]",80.0,0.0732969,"However, no significant differences were detected in forced vital capacity (P = .65), forced expiratory volume in 1 second (P = .50), peak expiratory flow (P = .73), and maximal voluntary ventilation (P = .27) between 2 groups.","[{'ForeName': 'Hai-Xia', 'Initials': 'HX', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Chinese PLA General Hospital, Beijing.'}, {'ForeName': 'Xue-Jiang', 'Initials': 'XJ', 'LastName': 'Du', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Ya-Juan', 'Initials': 'YJ', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Mi', 'Affiliation': 'Department of Anesthesiology, Chinese PLA General Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000021691']
2238,32899008,Independent risk factors evaluation for overall survival and cancer-specific survival in thyroid cancer patients with bone metastasis: A study for construction and validation of the predictive nomogram.,"Bone is a frequent site for the occurrence of metastasis of thyroid cancer (TC). TC with bone metastasis (TCBM) is associated with skeletal-related events (SREs), with poor prognosis and low overall survival (OS). Therefore, it is necessary to develop a predictive nomogram for prognostic evaluation. This study aimed to construct an effective nomogram for predicting the OS and cancer-specific survival (CSS) of TC patients with BM. Those TC patients with newly diagnosed BM were retrospectively examined over a period of 6 years from 2010 to 2016 using data from the Surveillance, Epidemiology and End Results (SEER) database. Demographics and clinicopathological data were collected for further analysis. Patients were randomly allocated into training and validation cohorts with a ratio of ∼7:3. OS and CSS were retrieved as research endpoints. Univariate and multivariate Cox regression analyses were performed for identifying independent predictors. Overall, 242 patients were enrolled in this study. Age, histologic grade, histological subtype, tumor size, radiotherapy, liver metastatic status, and lung metastatic status were determined as the independent prognostic factors for predicting the OS and CSS in TCBM patients. Based on the results, visual nomograms were separately developed and validated for predicting 1-, 2-, and 3-year OS and CSS in TCBM patients on the ground of above results. The calibration, receiver operating characteristic (ROC) curve and decision curve analysis (DCA) also demonstrated the reliability and accuracy of the clinical prediction model. Our predictive model is expected to be a personalized and easily applicable tool for evaluating the prognosis of TCBM patients, and may contribute toward making an accurate judgment in clinical practice.",2020,"TC with bone metastasis (TCBM) is associated with skeletal-related events (SREs), with poor prognosis and low overall survival (OS).","['TC patients with BM', 'thyroid cancer patients with bone metastasis', '242 patients were enrolled in this study', 'Those TC patients with newly diagnosed BM']",['TC with bone metastasis (TCBM'],"['overall survival and cancer-specific survival', 'Age, histologic grade, histological subtype, tumor size, radiotherapy, liver metastatic status, and lung metastatic status', 'OS and cancer-specific survival (CSS', 'calibration, receiver operating characteristic (ROC) curve and decision curve analysis (DCA']","[{'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0919553', 'cui_str': 'Histologic grade'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0006751', 'cui_str': 'Calibration'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",242.0,0.0214799,"TC with bone metastasis (TCBM) is associated with skeletal-related events (SREs), with poor prognosis and low overall survival (OS).","[{'ForeName': 'Yuexin', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Department of Minimally Invasive Spine Surgery, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province.'}, {'ForeName': 'Zhangheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Minimally Invasive Spine Surgery, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Minimally Invasive Spine Surgery, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province.'}, {'ForeName': 'Changxing', 'Initials': 'C', 'LastName': 'Chi', 'Affiliation': 'Department of Radiotherapy, The Third Affiliated Hospital of Kunming Medical University, Kunming, Yunnan Province.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Lv', 'Affiliation': 'Department of Ophthalmology, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Minimally Invasive Spine Surgery, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province.'}, {'ForeName': 'Chengliang', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Department of Minimally Invasive Spine Surgery, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province.'}, {'ForeName': 'Youxin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Minimally Invasive Spine Surgery, Affiliated Hospital of Chengde Medical University, Chengde, Hebei Province.'}]",Medicine,['10.1097/MD.0000000000021802']
2239,32899015,A randomized controlled trial for measuring effects on cognitive functions of adding ketamine to propofol during sedation for colonoscopy.,"BACKGROUND


The purpose of this study was to evaluate the effects of adding ketamine to propofol on cognitive functions in patients undergoing sedation for colonoscopy.
METHODS


In this randomized, double-blinded, and controlled study, 200 patients were randomly allocated to ketamine/propofol admixture group (Group KP, n = 100), and propofol group (Group P, n = 100). Patients in Group KP received 0.25 mg/kg of ketamine and 0.5 mg/kg of propofol. Patients in Group P received 0.5 mg/kg propofol. Cognitive functions were measured using CogState battery before and after the colonoscopy procedure. Ninety five patients in Group KP and 92 patients in Group P had completed the CogStates tests and were included in the data analysis.
RESULTS


Compared with before procedure baseline, the performance on detection and identification tasks were significantly impaired after the procedure in both Group KP (P = .004, P = .001) and Group P patients (P = .005, P < .001). However, one-card learning accuracy and One-back memory was only impaired in Group KP patients (P = .006, P = .040) after the endoscopy but left intact in Group P patients. Group KP patients showed more severe impairment in one-card learning accuracy compared with Group P patients (P = .044). Group KP patients have better 5 minutes MAP (P = .005) and were also less likely to suffer from complications such as respiratory depression (P = .023) and hypotension (P = .015). OAA/S scores, BIS, MAP, complications, recovery times, and endoscopist and patient satisfaction were similar between the 2 groups.
CONCLUSION


Although adding ketamine to propofol for sedation in colonoscopy provided fewer complications such as respiratory depression and hypotension, it also causes more impairment in cognitive functions.",2020,Group KP patients showed more severe impairment in one-card learning accuracy compared with Group P patients (P = .044).,"['patients undergoing sedation for colonoscopy', '200 patients']","['propofol', 'ketamine and 0.5\u200amg/kg of propofol', 'ketamine', 'ketamine/propofol admixture', 'ketamine to propofol']","['hypotension', 'severe impairment', 'cognitive functions', 'performance on detection and identification tasks', 'OAA/S scores, BIS, MAP, complications, recovery times, and endoscopist and patient satisfaction', 'Cognitive functions', 'respiratory depression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}]",200.0,0.0832811,Group KP patients showed more severe impairment in one-card learning accuracy compared with Group P patients (P = .044).,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Lianyungang.""}, {'ForeName': 'Hengfei', 'Initials': 'H', 'LastName': 'Luan', 'Affiliation': ""Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Lianyungang.""}, {'ForeName': 'Pin', 'Initials': 'P', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, The First People's Hospital of Lianyungang, Lianyungang.""}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology, Basic Medical Sciences of Nanjing Medical University.'}, {'ForeName': 'Hongguang', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000021859']
2240,32899022,Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK): A study protocol for a randomized controlled trial.,"INTRODUCTION


End stage renal failure patients on hemodialysis have significant vascular calcification This is postulated to be related to sub-clinical vitamin K deficiency, which is prevalent in hemodialysis patients. Vitamin K deficiency result in the failure of the matrix GLA protein (MGP) to undergo carboxylation. MGP is a natural local inhibitor of vascular calcification and the lack of functional carboxylated MGP may contribute to increase vascular calcification. Vitamin K supplement should therefore correct this anomaly and decrease the rate or severity of vascular calcification in this population of patients on long-term maintenance hemodialysis. Our study seeks to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients. It will also evaluate the efficacy of vitamin K supplementation in reducing the progression of vascular calcification in this group of patients.
METHODS


This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis. We aim to recruit 200 patients. Eligible patients will be randomized to either the standard care arm or active treatment arm. Active treatment arm patients will receive standard care plus supplementation with oral vitamin K2 isoform 360 mcg 3 times weekly for a total duration of 18 months. Primary outcome measured will be absolute difference in coronary artery calcification score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular over the same period.
DISCUSSION


Evidence of successful regression or retardation of vascular calcification will support the conduct of larger and longer-term trials aimed at reducing cardiovascular disease mortality and major adverse cardiovascular events in this high-risk population using a safe and inexpensive strategy TRIAL REGISTRATION:: ClinicalTrials.gov NCT02870829. Registered on 17 August 2016 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02870829National University Hospital's Institutional Review Board (2015/01000).",2020,"INTRODUCTION


End stage renal failure patients on hemodialysis have significant vascular calcification","['Eligible patients', 'hemodialysis patients', 'hemodialysis patients using', 'Registered on 17 August 2016 ', 'maintenance hemodialysis patients', 'stage renal failure patients on hemodialysis', '200 patients']","['standard care plus supplementation with oral vitamin K2 isoform', 'vitamin K supplementation', 'Vitamin K supplement', 'MGP', 'vitamin K (Trevasc-HDK']","['rate or severity of vascular calcification', 'coronary artery calcification score', 'progression of vascular calcification', 'aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular over the same period', 'vascular calcification']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C3661606', 'cui_str': 'Vitamin K supplement'}, {'cui': 'C0065752', 'cui_str': 'matrix Gla protein'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0428791', 'cui_str': 'Aortic valve calcification'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.160604,"INTRODUCTION


End stage renal failure patients on hemodialysis have significant vascular calcification","[{'ForeName': 'Sabrina-Wong-Peixin', 'Initials': 'SW', 'LastName': 'Haroon', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Bee-Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health.'}, {'ForeName': 'Lieng-Hsi', 'Initials': 'LH', 'LastName': 'Ling', 'Affiliation': 'National University Heart Center.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Teo', 'Affiliation': 'Department of Diagnostic Imaging, National University Hospital, Singapore.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davenport', 'Affiliation': 'UCL Centre for Nephrology, Royal Free Hospital, University College London, United Kingdom.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Schurgers', 'Affiliation': 'Department of Biochemistry, Cardiovascular Research Institute Maastricht, The Netherlands.'}, {'ForeName': 'Boon-Wee', 'Initials': 'BW', 'LastName': 'Teo', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Ching-Ching', 'Initials': 'CC', 'LastName': 'Ong', 'Affiliation': 'Department of Diagnostic Imaging, National University Hospital, Singapore.'}, {'ForeName': 'Sanmay', 'Initials': 'S', 'LastName': 'Low', 'Affiliation': 'Department of Medicine, Ng Teng Fong General Hospital.'}, {'ForeName': 'Xi-Er', 'Initials': 'XE', 'LastName': 'Yeo', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Jia-Neng', 'Initials': 'JN', 'LastName': 'Tan', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Subramanian', 'Affiliation': 'Kidney and Medical Clinic Pte Ltd, Parkway East Hospital.'}, {'ForeName': 'Horng-Ruey', 'Initials': 'HR', 'LastName': 'Chua', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Swee-Yaw', 'Initials': 'SY', 'LastName': 'Tan', 'Affiliation': 'National Heart Center Singapore, Singapore.'}, {'ForeName': 'Weng-Kin', 'Initials': 'WK', 'LastName': 'Wong', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}, {'ForeName': 'Titus-Wai-Leong', 'Initials': 'TW', 'LastName': 'Lau', 'Affiliation': 'Division of Nephrology, National University Hospital Singapore.'}]",Medicine,['10.1097/MD.0000000000021906']
2241,32899030,"Efficacy and safety of thread embedding acupuncture on knee osteoarthritis: A randomized, controlled, pilot clinical trial.","INTRODUCTION


Although there are various therapeutic methods for the treatment of knee osteoarthritis, each has its advantages and shortcomings, and a definitive treatment method is yet to be determined. This pilot study is designed to obtain basic data for a further large-scale trial as well as provide information about the feasibility of thread embedding acupuncture (TEA) with polydioxanone thread in knee osteoarthritis patients.
METHODS AND ANALYSIS


This study is a clinical trial to evaluate the efficacy and safety of TEA for knee osteoarthritis. Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control); they will be treated for 6 weeks. The experimental group will receive TEA treatment 6 times (1 time/week) in 6 weeks on 14 defined knee areas, and the control group, acupuncture treatments 12 times (2 times/week) in 6 weeks on 9 defined acupuncture points. The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment. The follow-ups before clinical trial, 3 weeks after procedure, 6 weeks after procedure, and 4 weeks after the end of procedure will be done to compare the degree of pain with the control group, which received the acupuncture treatment.
CONCLUSION


The trial based on this study will provide clinical information on the efficacy and safety of TEA treatment on knee osteoarthritis.
TRIAL REGISTRATION NUMBER


KCT0004844.",2020,"The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment.","['knee osteoarthritis', 'Forty participants will be recruited at the hospital and after randomization into 2 groups of 20 (experimental and control', 'knee osteoarthritis patients']","['thread embedding acupuncture', 'polydioxanone', 'acupuncture', 'TEA', 'acupuncture treatment', 'thread embedding acupuncture (TEA']","['visual analogue scale (VAS', 'efficacy and safety', 'Efficacy and safety']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0681454,"The visual analogue scale (VAS) will be used for the primary efficacy assessment and Short-form McGill Pain Questionnaire (SF-MPQ), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used for the secondary efficacy assessment.","[{'ForeName': 'Purumea', 'Initials': 'P', 'LastName': 'Jun', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Han', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang Sop', 'Initials': 'CS', 'LastName': 'Yang', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Min Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jae Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Cho In', 'Initials': 'CI', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Chung A', 'Initials': 'CA', 'LastName': 'Park', 'Affiliation': 'Department of Diagnostics, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}, {'ForeName': 'Young Joon', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, College of Korean Medicine, Daegu Haany University, Gyeongsan, Republic of Korea.'}, {'ForeName': 'Hyun-Jong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000021957']
2242,32899031,Clinical efficacy and imaging evaluation of recombinant tissue plasminogen activator thrombolytic therapy in patients with wake up stroke: A randomized controlled trial.,"INTRODUCTION


Wake up stroke starts in sleep and is a more common form of ischemic stroke. At present, it is still controversial whether wake up stroke can be treated with thrombolytic therapy. Therefore, this study will combine imaging techniques to assess the onset time of wake up stroke patients, and to analyze the imaging characteristics of wake up stroke patients and patients suitable for thrombolytic therapy within the time window.
METHODS/DESIGN


This study will be a single-blinded, randomized controlled trial with 2 parallel groups. It will be conducted at North China University of science and technology affiliated hospital.
DISCUSSION


There is no consistent conclusion about the pathogenesis of wake up stroke. Wake up stroke is more likely to manifest as small vessel disease. The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000034402, Registered on 05 July 2020.",2020,"The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies.
",['patients with wake up stroke'],['recombinant tissue plasminogen activator thrombolytic therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}]",[],,0.179453,"The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies.
","[{'ForeName': 'Chun-Yang', 'Initials': 'CY', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qiu-Yan', 'Initials': 'QY', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan-Ling', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Cui-Lan', 'Initials': 'CL', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021958']
2243,32899037,"Long-term safety and efficacy of mirogabalin in Asian patients with postherpetic neuralgia: Results from an open-label extension of a multicenter randomized, double-blind, placebo-controlled trial.","OBJECTIVE


Postherpetic neuralgia (PHN) is a condition that results from nerve dysfunction following an episode of acute herpes zoster (shingles). Mirogabalin is a novel, selective oral α2δ ligand that demonstrated safety and efficacy in a multicenter, randomized, double-blind, placebo-controlled 14-week study in Asian patients with PHN. This 52-week, open-label extension study investigated the long-term safety and efficacy of flexible-dosage mirogabalin in Asian patients with PHN.
METHODS


This open-label extension study enrolled patients who completed the placebo-controlled study. Patients started with a dose of 5 mg mirogabalin twice daily (BID), which was followed by a flexible dose of 10 or 15 mg BID. During the study, patients assessed their pain using the Short-Form McGill Pain Questionnaire (SF-MPQ). Adverse events were monitored throughout the study.
RESULTS


Of 239 enrolled patients, 184 (77.0%) completed the study and 185 patients (77.4%) received the 15 mg BID dose most during the treatment duration. Most treatment-emergent adverse events (TEAEs) were mild or moderate. The most common TEAEs were nasopharyngitis, somnolence, dizziness, weight increased, and edema. All SF-MPQ scales decreased from baseline to week 52.
CONCLUSIONS


This study showed the safety and stable pain management of a long-term flexible dosing regimen of mirogabalin 10 or 15 mg twice daily for 52 weeks in patients with PHN. CLINICAL TRIAL REGISTERED AT CLINICALTRIALS.GOV:: NCT02318719.
SUMMARY FOR TABLE OF CONTENTS


Mirogabalin-a novel α2δ oral ligand-was shown to be effective and well tolerated for treating postherpetic neuralgia (PHN) in an Asian multicenter, randomized, double-blind, placebo-controlled, 14-week study. This open-label, 52-week study was conducted as an extension of the double-blind study to demonstrate long-term safety and efficacy of mirogabalin.",2020,"All SF-MPQ scales decreased from baseline to week 52.
","['Asian patients with postherpetic neuralgia', 'Of 239 enrolled patients, 184 (77.0%) completed the study and 185 patients (77.4', 'patients with PHN', 'Asian patients with PHN']","['flexible-dosage mirogabalin', 'placebo', 'mirogabalin']","['All SF-MPQ scales', 'safety and stable pain management', 'Adverse events', 'pain using the Short-Form McGill Pain Questionnaire (SF-MPQ', 'nasopharyngitis, somnolence, dizziness, weight increased, and edema']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4043827', 'cui_str': 'mirogabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",239.0,0.349162,"All SF-MPQ scales decreased from baseline to week 52.
","[{'ForeName': 'Jitsu', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Department of Anesthesiology, Nihon University School of Medicine.'}, {'ForeName': 'Norimitsu', 'Initials': 'N', 'LastName': 'Matsui', 'Affiliation': 'Clinical Development Department.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kakehi', 'Affiliation': 'Clinical Development Department.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Murayama', 'Affiliation': 'Asia Development Department.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Ohwada', 'Affiliation': 'Biostatistics and Data Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Medicine,['10.1097/MD.0000000000021976']
2244,32899045,Clinical study on improving postoperative symptoms of cervical spondylotic myelopathy by Qishe pill.,"BACKGROUND


Cervical spondylotic myelopathy (CSM) is the most serious type of cervical spondylosis, which is often treated surgically in patients with progressive neurological symptoms following ineffective conservative treatment. However, some patients have residual symptoms such as neck pain, stiffness, and C5 nerve palsy after surgery. The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.
METHODS/DESIGN


A multicenter, randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the Qishe Pill. A total of 330 patients with CSM who receive surgical treatment will be randomly divided into 2 groups, treated for 12 weeks and with a 1-year follow-up. The primary outcome will be Japanese Orthopaedic Association score from the baseline to 4 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery. Secondary outcomes will include Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray). Additionally, adverse reactions will be observed and recorded as safety indicators.
DISCUSSION


Although the Qishe pill can effectively improve the discomfort of the neck and upper limbs in clinical applications, there is a lack of clinical research on postoperative patients. This study will investigate the efficacy and safety of the Qishe pill in treating postoperative symptoms of CSM.
TRIAL REGISTRATION


Clinical Trials.gov ID: ChiCTR1900028173. Registered on 17 December 2019.",2020,"The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.
","['330 patients with CSM who receive surgical treatment', 'patients with progressive neurological symptoms following ineffective conservative treatment']","['Cervical spondylotic myelopathy (CSM', 'Qishe pill']","['adverse reactions', 'efficacy and safety', 'Japanese Orthopaedic Association score', 'Visual Analogue Scale score, Neck Disability Index, and imaging indicators (including magnetic resonance imaging and X-ray']","[{'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]",330.0,0.17859,"The Qishe pill can effectively relieve the symptoms of neck pain and numbness, but there is no evidence showing the efficacy and safety of the Qishe pill in treating symptoms after spinal cord surgery.
","[{'ForeName': 'Jinhai', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chongqing', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Jin', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Xuequn', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Mo', 'Affiliation': 'Department of Orthopaedics, LongHua Hospital, Shanghai University of Traditional Chinese Medicine.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopaedics, Changzheng Hospital, Second Military Medical University, Shanghai, China.'}]",Medicine,['10.1097/MD.0000000000021994']
2245,32899057,Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid.,"Comparison of different anticoagulants in blood management and complications with tranexamic acid (TXA) in total hip arthroplasty (THA) is unclear. Our aim was to compare the efficacy and safety among receiving nadroparin calcium, enoxaparin sodium or rivaroxaban after TXA in THA.150 patients undergoing primary unilateral THA were received 15 mg/kg intravenous TXA (IV-TXA) before skin incision, followed by 1 of nadroparin calcium (Group A), enoxaparin sodium (Group B), or rivaroxaban (Group C) randomly during hospitalization. The primary outcome was hidden blood loss (HBL). Other outcomes such as the maximum hemoglobin (Hb) drop, total blood loss (TBL), the volume of drainage, transfusion rate, length of hospital stay (LOS), and complications were also compared.There were no statistically significant differences in HBL, the maximum hemoglobin (Hb) drop, transfusion rate, and complications among 3 groups. LOS was significantly higher for patients in Group B than Group A (P = .026). Neither deep venous thrombosis (DVT) nor pulmonary embolism (PE) occurred in any group.There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.",2020,"There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.","['patients undergoing THA receiving', 'THA.150 patients undergoing primary unilateral THA', 'total hip arthroplasty (THA']","['15\u200amg/kg intravenous TXA (IV-TXA) before skin incision, followed by 1 of nadroparin calcium (Group A), enoxaparin sodium (Group B), or rivaroxaban', 'tranexamic acid (TXA', 'tranexamic acid', 'nadroparin calcium, enoxaparin sodium or rivaroxaban', 'nadroparin calcium, enoxaparin sodium, or rivaroxaban']","['maximum hemoglobin (Hb) drop, total blood loss (TBL), the volume of drainage, transfusion rate, length of hospital stay (LOS), and complications', 'efficacy and safety', 'hidden blood loss (HBL', 'hidden blood loss', 'HBL, the maximum hemoglobin (Hb) drop, transfusion rate, and complications', 'deep venous thrombosis (DVT) nor pulmonary embolism (PE', 'LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0206232', 'cui_str': 'Nadroparin'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0724579', 'cui_str': 'Enoxaparin sodium'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}]",,0.0632438,"There were no differences in efficacy and safety in patients undergoing THA receiving nadroparin calcium, enoxaparin sodium, or rivaroxaban after anti-fibrinolysis with TXA.","[{'ForeName': 'Zeng-Fa', 'Initials': 'ZF', 'LastName': 'Deng', 'Affiliation': ""Department of Joint Surgery, the First Affiliated Hospital, Sun Yat-sen University, GuangZhou, GuangDong Province, People's Republic of China.""}, {'ForeName': 'Zi-Ji', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Pu-Yi', 'Initials': 'PY', 'LastName': 'Sheng', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Ai-Shan', 'Initials': 'AS', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Wei-Ming', 'Initials': 'WM', 'LastName': 'Liao', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022028']
2246,32899069,Effect of acupuncture method of removing-stasisand resuscitating on the consciousness of patients with severe traumatic brain injury: A randomized clinical trial.,"INTRODUCTION


With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury. Although the current craniocerebral medicine technology continues to advance, long-term bed rest and other complications have led to an insignificant decrease in the mortality rate of coma patients. It is not uncommon for patients with disturbance of consciousness caused by head injury in major hospitals.
METHODS/DESIGN


This will be a retrospective, single-blind clinical observational study. We will select 50 cases that meet the subject's selection criteria. According to whether they received acupuncture treatment or not, they will be randomly divided into 2 groups, namely treatment group and control group. The control group will be given conventional Western medicine treatment, and the treatment group will be given acupuncture method of removing-stasis and resuscitating treatment on the basis of the control group.
DISCUSSION


Our purpose is to observe the role of acupuncture method of removing-stasis and resuscitating in promoting the recovery of patients with severe head injury. We aim to provide more evidence-based medical evidence for acupuncture treatment of this disease.
TRIAL REGISTRATION


ClinicalTrials.gov, ChiCTR2000034732, Registered on 19 July 2020.",2020,"INTRODUCTION


With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury.","['patients with severe head injury', 'patients with severe traumatic brain injury', 'patients with disturbance of consciousness caused by head injury in major hospitals', 'patients with head injury']","['conventional Western medicine treatment', 'acupuncture', 'acupuncture method of removing-stasisand resuscitating']",['mortality rate'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0234428', 'cui_str': 'Disturbance of consciousness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1883720', 'cui_str': 'Removes'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0976505,"INTRODUCTION


With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury.","[{'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Pan', 'Affiliation': 'Wang Jing Hospital of China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Zhou', 'Initials': 'XZ', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022056']
2247,32899073,The fMRI study for acupuncture on shift work sleep disorder: Study protocol for a randomized controlled neuroimaging trial.,"INTRODUCTION


Nearly 20% of night shift nurses will cause shift work disorder (SWD) due to the disruption of sleep-wake cycle, which not only affects the daily work efficiency, but also brings a huge burden on physical and mental health. Acupuncture is a safe and effective intervention on SWD. This trial will combine with functional magnetic resonance imaging (fMRI) to study the clinical effects and potential mechanism of acupuncture in the treatment of SWD.
METHODS AND ANALYSIS


This is a randomized controlled neuroimaging trial, with enrolled participants, outcome assessors, and data statisticians blinded. 60 patients with SWD and 30 healthy controls who sleep regularly will be recruited and divided into divided into a control group, a true acupoints treatment group (TATG) and a sham acupoints treatment group (SATG) by the ratio of 1:1:1. The TATG and SATG will receive 8 sessions of acupuncture treatment in 4 weeks. Cognitive function scales and MRI scanning will be performed before and after 4-week acupuncture treatment. The control group will receive no intervention. Functional connectivity of intra-network and inter-network will be the primary outcome and effect indicator. The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale. Neuroimage indicators will be correlated with clinical data and scores of cognitive function assessment to explore the possible mechanisms underlying the changes of brain activity caused by acupuncture treatment.
DISCUSSION


The results of this study will enable us to verify the therapeutic effect of acupuncture on SWD and explore the potential central mechanism of acupuncture on SWD from the change of brain activity.",2020,"The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale.",['60 patients with SWD and 30 healthy controls who sleep regularly'],"['Acupuncture', 'acupuncture', 'functional magnetic resonance imaging (fMRI', 'true acupoints treatment group (TATG) and a sham acupoints treatment group (SATG']","['Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087539', 'cui_str': 'Shift work disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]",60.0,0.055346,"The secondary outcomes included Repeatable Battery for the Assessment of Neuropsychological Status, Attentional Network Test, Pittsburgh Sleep Quality Index scale and needle sensation assessment scale.","[{'ForeName': 'Yanzhe', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Xueyan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Yao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongfang Hospital affiliated to Beijing University of Chinese Medicine, Beijing100078, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}, {'ForeName': 'Hongxiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital affiliated to Capital Medical University.'}]",Medicine,['10.1097/MD.0000000000022068']
2248,32899074,What is the optimal regimen for intravenous dexamethasone administration in primary total hip arthroplasty?: A protocol of randomized controlled trial.,"BACKGROUND


A number of recent studies have investigated the optimal dosage and timing of dexamethasone in total hip arthroplasty (THA) but have inconsistent findings. Therefore, we designed the randomized controlled research to look for the optimal intravenous dexamethasone dose for the treatment of early postoperative pain after the THA.
METHODS


The Declaration of Helsinki principles was followed and the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials was adhered in this study. The First Medical Center in People's Liberation Army General Hospital approved the study (2020-089). After written informed consent was obtained, patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA, were included in this present work. Randomization is the use of a computer-formed list via a secretary, at a ratio of 1:1:1. The major end points were pain scores at 24 hours, 48 hours, and 72 hours after surgery, with visual analog scale (VAS) utilized at rest, and at 45 degrees passive hip flexion. The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.
RESULTS


We assumed that the patients who received 3 doses of dexamethasone intravenously possessed the best postoperative results compared to those who received 1 or 2 doses of the dexamethasone.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5864).",2020,"The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.
","['patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA', 'early postoperative pain after the THA', 'total hip arthroplasty (THA']",['dexamethasone'],"['visual analog scale (VAS', 'total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.183182,"The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay.
","[{'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Liang', 'Affiliation': 'Department of Orthopedics, The First Medical Center in PLA General Hospital, Beijing, 100853, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022070']
2249,32899089,Short-term clinical efficacy of the pulsed Nd: YAG laser therapy on chronic nonspecific low back pain: A randomized controlled study.,"BACKGROUND


Chronic non-specific low back pain (LBP) is gradually increasing among populations worldwide and affects their activities. Recently, the Nd:YAG laser has been presented in the rehabilitation field.
OBJECTIVES


This study aims to explore the short-term effects of the Nd:YAG laser on chronic non-specific LBP individuals.
METHODS


Thirty-five individuals with chronic nonspecific LBP were included in the study from December 2019 to March 2020. Randomly, they were categorized to Nd:YAG group (n = 18) and sham laser as a control (n = 17) thrice weekly for a 6-week intervention. Modified Oswestry disability index (MODI), pain disability index (PDI), visual analogue scale (VAS), and lumbar flexion range of motion (ROM) have been assessed pre and post-6 weeks of the intervention.
RESULTS


Significant improvements were observed in the Nd:YAG group (MODI, P < .001; PDI, P = .007; VAS, P < .001; lumbar ROM, P = .002), whereas the sham group showed no significant changes (MODI, P = .451; PDI, P = .339; VAS, P = .107; lumbar ROM, P = .296) after 6-week intervention. Between-group comparisons showed significant differences in tending toward the Nd:YAG group (MODI, P < .001; PDI, P = .046; VAS, P < .001; lumbar ROM, P = .003).
CONCLUSIONS


Regarding the present study outcomes, short-term pulsed Nd:YAG laser (6 weeks) may reduce functional disabilities and pain intensity, and improve the lumbar flexion ROM in patients with chronic nonspecific LBP. Further well-designed randomized controlled studies with large sample sizes should be conducted regarding laser treatment.",2020,"RESULTS


Significant improvements were observed in the Nd:YAG group (MODI, P < .001; PDI, P = .007; VAS, P < .001; lumbar ROM, P = .002), whereas the sham group showed no significant changes (MODI, P = .451; PDI, P = .339; VAS, P = .107; lumbar ROM, P = .296) after 6-week intervention.","['chronic nonspecific low back pain', 'Thirty-five individuals with chronic nonspecific LBP were included in the study from December 2019 to March 2020', 'patients with chronic nonspecific LBP', 'Chronic non-specific low back pain (LBP', 'chronic non-specific LBP individuals']","['pulsed Nd: YAG laser therapy', 'short-term pulsed Nd:YAG laser', 'Nd:YAG laser']","['lumbar flexion ROM', 'Modified Oswestry disability index (MODI), pain disability index (PDI), visual analogue scale (VAS), and lumbar flexion range of motion (ROM', 'functional disabilities and pain intensity']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",35.0,0.0402863,"RESULTS


Significant improvements were observed in the Nd:YAG group (MODI, P < .001; PDI, P = .007; VAS, P < .001; lumbar ROM, P = .002), whereas the sham group showed no significant changes (MODI, P = .451; PDI, P = .339; VAS, P = .107; lumbar ROM, P = .296) after 6-week intervention.","[{'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Nahla N', 'Initials': 'NN', 'LastName': 'Ataalla', 'Affiliation': 'Department of Radiological Sciences and Medical Imaging, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'Department of Orthopedic, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Samah A', 'Initials': 'SA', 'LastName': 'Moawd', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Riyadh, Saudi Arabia.'}]",Medicine,['10.1097/MD.0000000000022098']
2250,32899094,Comparison of ropivacaine plus sufentanil and ropivacaine plus dexmedetomidine for labor epidural analgesia: A randomized controlled trial protocol.,"OBJECTIVE


Effective analgesia during delivery can not only decrease pain, but also have a significant function in ensuring the safety of baby and mother. Sufentanil is generally used opioid with ropivacaine in epidural anesthesia in labor pain management; however it can cause some adverse reaction. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity. It possesses opioid-sparing and analgesic effects and it is suitable for the long-term and short-term intraoperative sedation. The purpose of this present study is to compare the analgesic effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanyl in epidural labor.
METHODS


This is a single center, placebo-controlled randomized trial which will be performed from May 2020 to May 2021. It was authorized via the Institutional Review Committee in the first medical center of Chinese PLA General Hospital (S2018-211-0). One hundred sixty full-term protozoa are included in this work. They are randomly divided into four groups (n = 40 per group): the RD1 group (with the epidural administration of 0.125% ropivacaine + dexmedetomidine of 0.5 μg/mL), and the RD2 group (with the epidural administration of 0.08% ropivacaine + dexmedetomidine 0.5 μg/mL), the RS1 group (with the epidural administration of 0.125% ropivacaine + sufentanil of 0.5 μg/mL), as well as RS2 group (with the epidural administration of 0.08% ropivacaine + sufentanil of 0.5 μg/mL). Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia. All the needed analyses are implemented through utilizing SPSS for Windows Version 20.0.
RESULTS


The first table shows the clinical outcomes between these four groups.
CONCLUSION


This current work can provide a primary evidence regarding the clinical outcomes of dexmedetomidine versus sufentanil for labor epidural analgesia.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5877).",2020,"Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia.","['labor pain management', 'One hundred sixty full-term protozoa are included in this work', 'labor epidural analgesia']","['RD2 group (with the epidural administration of 0.08% ropivacaine + dexmedetomidine', 'sufentanil', 'ropivacaine', 'RS1 group (with the epidural administration of 0.125% ropivacaine + sufentanil', 'ropivacaine plus sufentanil', 'ropivacaine plus dexmedetomidine', 'Dexmedetomidine', 'RD1 group (with the epidural administration of 0.125% ropivacaine + dexmedetomidine', 'placebo', 'ropivacaine + sufentanil', 'dexmedetomidine', 'Sufentanil']","['pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions', 'analgesic effect']","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033739', 'cui_str': 'Kingdom Protozoa'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4517417', 'cui_str': '0.08'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517427', 'cui_str': '0.125'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1301887', 'cui_str': 'Bromage scale'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",,0.124476,"Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia.","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'Maowei', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000022113']
2251,32899104,A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension: Erratum.,,2020,,['Chinese patients with essential hypertension'],"['azilsartan medoxomil', 'valsartan']",[],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]",[],,0.236347,,[],Medicine,['10.1097/MD.0000000000022168']
2252,32899107,The Effect of Resistance Exercise Intensity on Acute Hyperglycemia in Young Adult Males.,"The purpose of this study was to examine the effect of resistance exercise (RE) intensity on acute hyperglycemia, in young adult males. Thirteen males (age 23.43 ± 2.18 years, height 175.16 ± 10.44 cm, weight 77.02 ± 8.91 kg, body fat 20 ± 0.03%) participated in three randomized testing sessions, each separated by 96 h. The three testing conditions were: control (CON; induction of hyperglycemia with no-exercise), high (HI; induction of hyperglycemia followed by high-intensity RE: 5 × 4, 90% 1-repetition maximum (1-RM)), and moderate (MO; induction of hyperglycemia followed by low-intensity RE: 3 × 14, 65% 1-RM). In all three testing conditions, participants orally ingested a D100 (100 g/10 oz) glucose beverage at a dosage of 2 g glucose/kg body weight and capillary blood was obtained for plasma glucose and insulin analysis at 0 (fasting), 30, 60, 90 and 120 min, following glucose ingestion. At 30-min post-ingestion in the HI and MO conditions, participants began the respective RE protocols. Acute hyperglycemia was achieved throughout all three 2-h testing conditions; mean 2-h plasma glucose levels during CON (7.1 ± 1.3 mmol∙L -1 ), MO (7.5 ± 0.6 mmol∙L -1 ) and HI (8.2 ± 1.9 mmol∙L -1 ) were all significantly ( p  < 0.05) greater than mean fasting plasma glucose (5.6 ± 0.46 mmol∙L -1 ). Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO. In conclusion, this study indicates that hyperglycemia, induced prior to RE, may be exacerbated by high-intensity RE.",2020,"Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO.","['Young Adult Males', 'Thirteen males (age 23.43 ± 2.18 years, height 175.16 ± 10.44 cm, weight 77.02 ± 8.91 kg, body fat 20 ± 0.03%) participated in three randomized testing sessions, each separated by 96 h', 'young adult males']","['Resistance Exercise Intensity', 'resistance exercise (RE) intensity', 'control (CON; induction of hyperglycemia with no-exercise), high (HI; induction of hyperglycemia followed by high-intensity RE']","['2-h glucose area under the curve in the HI condition', 'Acute Hyperglycemia', 'Plasma glucose and insulin', 'Acute hyperglycemia', 'mean fasting plasma glucose', 'plasma glucose levels']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0342301', 'cui_str': 'Acute hyperglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0280633,"Plasma glucose and insulin did not differ ( p  < 0.05) between treatment conditions at any times points over the 120 min, however, 2-h glucose area under the curve in the HI condition was significantly greater ( p  < 0.05) than CON and MO.","[{'ForeName': 'Evan E', 'Initials': 'EE', 'LastName': 'Schick', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Segura', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Shayán', 'Initials': 'S', 'LastName': 'Emamjomeh', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cotter', 'Affiliation': 'Physiology of Exercise and Sport Laboratory, California State University, Long Beach, CA 90840, USA.'}]","Sports (Basel, Switzerland)",['10.3390/sports8090121']
2253,32899135,Impact of a Three-Year Obesity Prevention Study on Healthy Behaviors and BMI among Lebanese Schoolchildren: Findings from Ajyal Salima Program.,"Most school-based obesity prevention programs in low- to middle-income countries are of short duration, and few undertake follow-up analyses after the termination of the project. The aims of the current study are to investigate (1) the long-term effects of a school-based intervention program when implemented over two years on body mass index (BMI), healthy dietary behaviors, and physical activity (PA); and (2) whether the effects are sustained after one-year washout. The study is a cluster-randomized trial; 36 public and private schools were randomized into either intervention or control groups. Students (8-12 years) completed pre-and post-assessment anthropometric measurements and questionnaires about their eating and physical activity habits. Students in the intervention groups received the program components for two consecutive years. Multiple logistic regression models were used to examine the effect of the intervention on BMI and healthy behaviors. Students in the intervention groups were less likely to be overweight at washout, only in public schools. The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools. Policies aiming at securing a positive nutrition environment in schools, and adoption of nutrition programs, are needed for achieving sustained behavior and prompting BMI changes in children.",2020,"The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools.","['Healthy Behaviors and BMI among Lebanese Schoolchildren', '36 public and private schools']",['school-based intervention program'],"['body mass index (BMI), healthy dietary behaviors, and physical activity (PA', 'BMI and healthy behaviors', 'dietary behaviors']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",36.0,0.0164201,"The number of children reporting change in dietary behaviors significantly increased in intervention groups, with a sustained effect only in public schools.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Habib-Mourad', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Lilian A', 'Initials': 'LA', 'LastName': 'Ghandour', 'Affiliation': 'Department of Epidemiology and Population Health, Faculty of Health Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Maliha', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Dagher', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Kharroubi', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}, {'ForeName': 'Nahla', 'Initials': 'N', 'LastName': 'Hwalla', 'Affiliation': 'Department of Nutrition and Food Sciences, Faculty of Agriculture and Food Sciences, American University of Beirut, Beirut 11-0236, Lebanon.'}]",Nutrients,['10.3390/nu12092687']
2254,32899227,"Ubiquinone Supplementation with 300 mg on Glycemic Control and Antioxidant Status in Athletes: A Randomized, Double-Blinded, Placebo-Controlled Trial.","The aim of this study is to investigate the glycemic profile, oxidative stress, and antioxidant capacity in athletes after 12 weeks of ubiquinone supplementation. It was a double-blinded, randomized, parallel, placebo-controlled study. Thirty-one well-trained college athletes were randomly assigned to ubiquinone (300 mg/d,  n  = 17) or placebo group ( n  = 14). The glycemic profile [fasting glucose, glycated hemoglobin (HbA1c), homeostatic model assessment-insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI)], plasma and erythrocyte malondialdehyde (MDA), total antioxidant capacity (TAC), and ubiquinone status were measured. After supplementation, the plasma ubiquinone concentration was significantly increased ( p  < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group ( p  < 0.01). There was a significant correlation between white blood cell (WBC) ubiquinone and glycemic parameters [HbA1c,  r  = -0.46,  p  < 0.05; HOMA-IR,  r  = -0.67,  p  < 0.01; QUICKI,  r  = 0.67,  p  < 0.01]. In addition, athletes with higher WBC ubiquinone level (≥0.5 nmol/g) showed higher erythrocyte TAC and QUICKI and lower HOMA-IR. In conclusion, we demonstrated that athletes may show a better antioxidant capacity with higher ubiquinone status after 12 weeks of supplementation, which may further improve glycemic control.",2020,"After supplementation, the plasma ubiquinone concentration was significantly increased ( p  < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group ( p  < 0.01).","['Athletes', 'athletes after 12 weeks of ubiquinone supplementation', 'Thirty-one well-trained college athletes']","['placebo', 'Placebo', 'ubiquinone', 'Ubiquinone Supplementation']","['erythrocyte TAC and QUICKI and lower HOMA-IR', 'WBC ubiquinone level', 'plasma ubiquinone concentration', 'level of erythrocyte MDA', 'white blood cell (WBC) ubiquinone and glycemic parameters', 'glycemic profile [fasting glucose, glycated hemoglobin (HbA1c), homeostatic model assessment-insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI)], plasma and erythrocyte malondialdehyde (MDA), total antioxidant capacity (TAC), and ubiquinone status', 'glycemic profile, oxidative stress, and antioxidant capacity', 'glycemic control']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557806', 'cui_str': 'College'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1532468', 'cui_str': 'Ubiquinone level'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041536', 'cui_str': 'Coenzyme Q'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",31.0,0.298316,"After supplementation, the plasma ubiquinone concentration was significantly increased ( p  < 0.05) and the level of erythrocyte MDA was significantly lower in the ubiquinone group than in the placebo group ( p  < 0.01).","[{'ForeName': 'Chien-Chang', 'Initials': 'CC', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Po-Sheng', 'Initials': 'PS', 'LastName': 'Chang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 402367, Taiwan.'}, {'ForeName': 'Hung-Wun', 'Initials': 'HW', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 402367, Taiwan.'}, {'ForeName': 'Po-Fu', 'Initials': 'PF', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Yun-Chi', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Ching-Yu', 'Initials': 'CY', 'LastName': 'Tseng', 'Affiliation': 'Department of Physical Education, Fu Jen Catholic University, New Taipei City 242304, Taiwan.'}, {'ForeName': 'Ping-Ting', 'Initials': 'PT', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 402367, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9090823']
2255,32899289,Caloric and Macronutrient Intake and Meal Timing Responses to Repeated Sleep Restriction Exposures Separated by Varying Intervening Recovery Nights in Healthy Adults.,"Sleep restriction (SR) reliably increases caloric intake. It remains unknown whether such intake cumulatively increases with repeated SR exposures and is impacted by the number of intervening recovery sleep opportunities. Healthy adults (33.9 ± 8.9y; 17 women, Body Mass Index: 24.8 ± 3.6) participated in a laboratory protocol. N = 35 participants experienced two baseline nights (10 h time-in-bed (TIB)/night; 22:00-08:00) followed by 10 SR nights (4 h TIB/night; 04:00-08:00), which were divided into two exposures of five nights each and separated by one (n = 13), three (n = 12), or five (n = 10) recovery nights (12 h TIB/night; 22:00-10:00). Control participants (n = 10) were permitted 10 h TIB (22:00-08:00) on all nights. Food and drink consumption were ad libitum and recorded daily. Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions. Similarly, although sleep-restricted participants exhibited substantial late-night caloric intake (671 kcal), such intake did not differ between exposures or recovery conditions. By contrast, control participants showed no changes in caloric intake across days. We found consistent caloric and macronutrient intake increases during two SR exposures despite varying intervening recovery nights. Thus, energy intake outcomes do not cumulatively increase with repeated restriction and are unaffected by recovery opportunities.",2020,"Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions.","['Healthy Adults', 'Healthy adults (33.9 ± 8.9y; 17 women, Body Mass Index: 24.8 ± 3.6) participated in a laboratory protocol']",['Sleep restriction (SR'],"['daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein', 'caloric intake', 'substantial late-night caloric intake']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",10.0,0.0223244,"Compared to baseline, sleep-restricted participants increased daily caloric (+527 kcal) and saturated fat (+7 g) intake and decreased protein (-1.2% kcal) intake during both SR exposures; however, intake did not differ between exposures or recovery conditions.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Spaeth', 'Affiliation': 'Department of Kinesiology and Health, Division of Life Sciences, School of Arts and Sciences, Rutgers University, New Brunswick, NJ 08901, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60612, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA.'}]",Nutrients,['10.3390/nu12092694']
2256,32899447,Exercise Training and Vitamin C Supplementation Affects Ferritin mRNA in Leukocytes without Affecting Prooxidative/Antioxidative Balance in Elderly Women.,"Physical training and antioxidant supplementation may influence iron metabolism through reduced oxidative stress and subsequent lowering of mRNA levels of genes that are easily induced by this stress, including those responsible for iron homeostasis. Fifteen elderly women participated in our 12-week experiment, involving six weeks of training without supplementation and six weeks of training supported by oral supplementation of 1000 mg of vitamin C daily. The participants were divided into two groups ( n  = 7 in group 1 and  n  = 8 in group 2). In group 1, we applied vitamin C supplementation in the first six weeks of training, while in group 2 during the remaining six weeks of training. In both phases, the health-related training occurred three times per week. Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  p  = 0.03 in group 1 and from 2^60.54 to 2^16.03,  p  = 0.01 in group 2, for  FTL  mRNA from 2^20.22 to 2^4.53,  p  = 0.01 in group 2). We concluded that vitamin C supplementation might have caused a decrease in gene expression of two important antioxidative genes ( FTH, FTL)  and had no effect on plasma prooxidative/antioxidative balance.",2020,"Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  ","['Fifteen elderly women', 'Elderly Women']","['vitamin C supplementation', 'training without supplementation and six weeks of training supported by oral supplementation of 1000 mg of vitamin C daily', 'Exercise Training and Vitamin C Supplementation', 'Physical training and antioxidant supplementation']","['ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes', 'prooxidative/antioxidative balance', 'plasma prooxidative/antioxidative balance']","[{'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040608', 'cui_str': 'Training Support'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0162905', 'cui_str': 'H-Ferritin'}, {'cui': 'C1855305', 'cui_str': 'Frank-Ter Haar syndrome'}, {'cui': 'C0391764', 'cui_str': 'L-Ferritin'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",15.0,0.0181971,"Training accompanied by vitamin C supplementation did not affect prooxidative/antioxidative balance but significantly decreased ferritin heavy chain  (FTH ) and ferritin light chain ( FTL ) mRNA in leukocytes (for  FTH  mRNA from 2^64.24 to 2^11.06,  ","[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Żychowska', 'Affiliation': 'Department of Sport, Faculty of Physical Education, Kazimierz Wielki University in Bydgoszcz, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Grzybkowska', 'Affiliation': 'Department of Biochemistry, Faculty of Physical Education, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Wiech', 'Affiliation': 'Department of Health Promotion, Faculty of Tourism and Recreation, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Urbański', 'Affiliation': 'Department of Biomechanics and Sports Engineering, Faculty of Physical Education, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Pilch', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Piotrowska', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Czerwińska-Ledwig', 'Affiliation': 'Department of Cosmetology, Faculty of Physiotherapy, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Exercise Physiology, Faculty of Health, Medical University of Gdansk, 80-210 Gdansk, Poland.'}]",International journal of molecular sciences,['10.3390/ijms21186469']
2257,32899538,Genetic Testing and Surveillance of Young Breast Cancer Survivors and Blood Relatives: A Cluster Randomized Trial.,"We compared a tailored and a targeted intervention designed to increase genetic testing, clinical breast exam (CBE), and mammography in young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives. A two-arm cluster randomized trial recruited a random sample of YBCS from the Michigan cancer registry and up to two of their blood relatives. Participants were stratified according to race and randomly assigned as family units to the tailored ( n  = 637) or the targeted ( n  = 595) intervention. Approximately 40% of participants were Black. Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services ( p  = 0.0205) at 8-months follow-up. Genetic testing increased approximately 5% for YBCS in the tailored and the targeted arm ( p  ≤ 0.001;  p  < 0.001) and for Black and White/Other YBCS ( p  < 0.001;  p  < 0.001). CBEs and mammograms increased significantly in both arms, 5% for YBCS and 10% for relatives and were similar for Blacks and White/Others. YBCS and relatives needing less support from providers reported significantly higher self-efficacy and intention for genetic testing and surveillance. Black participants reported significantly higher satisfaction and acceptability. Effects of these two low-resource interventions were comparable to previous studies. Materials are suitable for Black women at risk for hereditary breast/ovarian cancer (HBOC).",2020,"Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services ( p  = 0.0205) at 8-months follow-up.","['young breast cancer survivors (YBCS) (diagnosed <45 years old) and their blood relatives', 'Young Breast Cancer Survivors and Blood Relatives', 'from the Michigan cancer registry and up to two of their blood relatives', 'Black women at risk for hereditary breast/ovarian cancer (HBOC']",['YBCS'],"['Genetic testing', 'satisfaction and acceptability', 'CBEs and mammograms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1266852', 'cui_str': 'Blood relative'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]",,0.0638018,"Based on intention-to-treat analyses, YBCS in the tailored arm reported higher self-efficacy for genetic services ( p  = 0.0205) at 8-months follow-up.","[{'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Katapodi', 'Affiliation': 'Department of Clinical Research, Faculty of Medicine, University of Basel, 4055 Basel, Switzerland.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ming', 'Affiliation': 'Department of Clinical Research, Faculty of Medicine, University of Basel, 4055 Basel, Switzerland.'}, {'ForeName': 'Laurel L', 'Initials': 'LL', 'LastName': 'Northouse', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI 48109-5482, USA.'}, {'ForeName': 'Sonia A', 'Initials': 'SA', 'LastName': 'Duffy', 'Affiliation': 'College of Nursing, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Duquette', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Kari E', 'Initials': 'KE', 'LastName': 'Mendelsohn-Victor', 'Affiliation': 'School of Nursing, University of Michigan, Ann Arbor, MI 48109-5482, USA.'}, {'ForeName': 'Kara J', 'Initials': 'KJ', 'LastName': 'Milliron', 'Affiliation': 'Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI 48109-5618, USA.'}, {'ForeName': 'Sofia D', 'Initials': 'SD', 'LastName': 'Merajver', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI 48109-5618, USA.'}, {'ForeName': 'Ivo D', 'Initials': 'ID', 'LastName': 'Dinov', 'Affiliation': 'Statistics Online Computational Resource, School of Nursing, University of Michigan, Ann Arbor, MI 48109-2003, USA.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Janz', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI 48109-5618, USA.'}]",Cancers,['10.3390/cancers12092526']
2258,32899673,Effects of Maternal Fish Oil and/or 5-Methyl-Tetrahydrofolate Supplementation during Pregnancy on Offspring Brain Resting-State at 10 Years Old: A Follow-Up Study from the NUHEAL Randomized Controlled Trial.,"Recent studies have shown that maternal supplementation with folate and long-chain polyunsaturated fatty acids (LC-PUFAs) during pregnancy may affect children's brain development. We aimed at examining the potential long-term effect of maternal supplementation with fish oil (FO) and/or 5-methyl-tetrahydrofolate (5-MTHF) on the brain functionality of offspring at the age of 9.5-10 years. The current study was conducted as a follow-up of the Spanish participants belonging to the Nutraceuticals for a Healthier Life (NUHEAL) project; 57 children were divided into groups according to mother's supplementation and assessed through functional magnetic resonance imaging (fMRI) scanning and neurodevelopment testing. Independent component analysis and double regression methods were implemented to investigate plausible associations. Children born to mothers supplemented with FO (FO and FO + 5-MTHF groups,  n  = 33) showed weaker functional connectivity in the default mode (DM) (angular gyrus), the sensorimotor (SM) (motor and somatosensory cortices) and the fronto-parietal (FP) (angular gyrus) networks compared to the No-FO group (placebo and 5-MTHF groups,  n  = 24) (P FWE  < 0.05). Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test. Considering the No-FO group, the aforementioned networks were associated negatively with attention and speed-processing functions. Mother's FO supplementation during pregnancy seems to be able to shape resting-state network functioning in their children at school age and appears to produce long-term effects on children´s cognitive processing.",2020,"Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test.","['offspring at the age of 9.5-10 years', 'Spanish participants belonging to the Nutraceuticals for a Healthier Life (NUHEAL) project; 57 children', 'Offspring Brain Resting-State at 10 Years Old']","['maternal supplementation with fish oil (FO) and/or 5-methyl-tetrahydrofolate (5-MTHF', 'FO (FO and FO + 5-MTHF', ""mother's supplementation and assessed through functional magnetic resonance imaging (fMRI) scanning and neurodevelopment testing"", 'Maternal Fish Oil and/or 5-Methyl-Tetrahydrofolate Supplementation', 'maternal supplementation with folate and long-chain polyunsaturated fatty acids (LC-PUFAs']","['object recall (memory) test', 'functional connectivity', 'attention and speed-processing functions', 'sensorimotor (SM) (motor and somatosensory cortices) and the fronto-parietal (FP) (angular gyrus) networks']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0039669', 'cui_str': 'Tetrahydrofolates'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}]","[{'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0152305', 'cui_str': 'Structure of angular gyrus'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",57.0,0.0369052,"Furthermore, no differences were found regarding the neuropsychological tests, except for a trend of better results in an object recall (memory) test.","[{'ForeName': 'Hatim', 'Initials': 'H', 'LastName': 'Azaryah', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Verdejo-Román', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martin-Pérez', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'García-Santos', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez-Zaldívar', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Torres-Espínola', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Ludwig-Maximiliams-Universität München, Dr. von Hauner Children's Hospital, University of Munich Hospitals, 80337 Munich, Germany.""}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Pérez-García', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Catena', 'Affiliation': 'Mind, Brain and Behaviour International Research Centre (CIMCYC), University of Granada, 18011 Granada, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campoy', 'Affiliation': 'Department of Paediatrics, School of Medicine, University of Granada, Avda. Investigación 11, 18016 Granada, Spain.'}]",Nutrients,['10.3390/nu12092701']
2259,32899723,Early Loading of Mandibular Molar Single Implants: 1 Year Results of a Randomized Controlled Clinical Trial.,"The purpose of this study was to compare the implant survival, peri-implant marginal bone level, and peri-implant soft tissue of three different types of implants. This was performed with an early loading protocol, using a complete digital workflow, for one year of follow-up. Twenty-four patients with a single missing tooth in the mandibular posterior region were randomly assigned to the control group (SLActive Bone level implant; Institut Straumann AG, Basel, Switzerland), experiment group 1 (CMI IS-III Active implant; Neobiotech Co., Seoul, Korea), and experiment group 2 (CMI IS-III HActive implant; Neobiotech Co., Seoul, Korea). For each patient, a single implant was installed using the surgical template, and all prostheses were fabricated using a computer-aided design/computer-aided manufacturing system on a 3-dimensional model. A provisional prosthesis was implanted at 4 weeks, and a definitive monolithic zirconia prosthesis was substituted 12 weeks following the implant placement. The implant stability quotient (ISQ) and peri-implant soft tissue parameters were measured, and periapical radiographs were taken at 1, 3, 4, 8, 12, 24, 36, and 48 weeks after implant placements. Seven implants in the control group, nine implants in the experiment 1 group, and eight implants in the experiment 2 group were analyzed. There were no significant differences among the three groups in terms of insertion torque, ISQ values between surgery and 8 weeks of follow-up, marginal bone loss at 48 weeks of follow-up, and peri-implant soft tissue parameters ( P  > 0.05). Statistically significant differences in ISQ values were observed between the control and experiment 1 groups, and the control and experiment 2 groups at the 12 to 48 weeks' follow-ups. Within the limits of this prospective study, an early loading protocol can be applied as a predictable treatment modality in posterior mandibular single missing restorations, achieving proper primary stability.",2020,"There were no significant differences among the three groups in terms of insertion torque, ISQ values between surgery and 8 weeks of follow-up, marginal bone loss at 48 weeks of follow-up, and peri-implant soft tissue parameters ( P  > 0.05).",['Twenty-four patients with a single missing tooth in the mandibular posterior region'],"['control group (SLActive Bone level implant; Institut Straumann AG, Basel, Switzerland), experiment group 1 (CMI IS-III Active implant; Neobiotech Co., Seoul, Korea), and experiment group 2 (CMI IS-III', 'Mandibular Molar Single Implants']","['ISQ values', 'marginal bone loss', 'implant stability quotient (ISQ) and peri-implant soft tissue parameters', 'implant survival, peri-implant marginal bone level', 'insertion torque, ISQ values']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",24.0,0.0369916,"There were no significant differences among the three groups in terms of insertion torque, ISQ values between surgery and 8 weeks of follow-up, marginal bone loss at 48 weeks of follow-up, and peri-implant soft tissue parameters ( P  > 0.05).","[{'ForeName': 'Jungwon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Young-Jun', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': 'Department of Prosthodontics and Dental Research Institute, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}, {'ForeName': 'Bongju', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Dental Life Science Research Institute & Clinical Translational Research Center for Dental Science, Seoul National University Dental Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Ki-Tae', 'Initials': 'KT', 'LastName': 'Koo', 'Affiliation': 'Department of Periodontology and Dental Research Institute, School of Dentistry, Seoul National University, Seoul 03080, Korea.'}]","Materials (Basel, Switzerland)",['10.3390/ma13183912']
2260,32899902,Effect of Passive Stretching of Respiratory Muscles on Chest Expansion and 6-Minute Walk Distance in COPD Patients.,"BACKGROUND


Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Hyperinflation of the lungs leads to a remodeling of the inspiratory muscles that causes postural deformities and more labored breathing. Postural changes include elevated, protracted, or abducted scapulae with medially rotated humerus, and kyphosis that leads to further tightening of respiratory muscles. As the severity of the disease progresses, use of the upper limbs for functional tasks becomes difficult due to muscle stiffness. There are various studies that suggest different rehabilitation programs for COPD patients; however, to the best of our knowledge none recommends passive stretching techniques. The aim of this study was to assess the effect of respiratory muscle passive stretching on chest expansion and 6-min walk distance (6MWD) in patients with moderate to severe COPD.
METHODS


Thirty patients were divided into two groups, experimental ( n  = 15) and control ( n  = 15). The experimental group received a hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints. The control group received a hot pack followed by relaxed passive movements of the shoulder joints.
RESULTS


In the control group, there was no difference in chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD between baseline and post treatment ( p  > 0.05). In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05). A comparison between control and experimental groups showed that chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.01) were significantly higher in the experimental group, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).
CONCLUSIONS


Although COPD is an irreversible disease, results of this study indicate that passive stretching of respiratory muscles can clinically improve the condition of such patients, especially in terms of chest expansion and 6MWD. Given the good effects of muscle stretching and the fact that such an exercise is harmless, clinicians and physiotherapists should consider including passive stretching of respiratory muscles in the rehabilitation plan of COPD patients.",2020,"In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).","['COPD patients', 'Chronic obstructive pulmonary disease (COPD', 'patients with moderate to severe COPD', 'COPD Patients', 'Thirty patients']","['Passive Stretching of Respiratory Muscles', 'hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints', 'respiratory muscle passive stretching', 'hot pack followed by relaxed passive movements of the shoulder joints']","['chest expansion', 'chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD', 'chest expansion and 6-min walk distance (6MWD', 'Chest Expansion and 6-Minute Walk Distance', '6MWD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]","[{'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0043356', 'cui_str': 'Structure of xiphoid process of sternum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",30.0,0.0204537,"In the experimental group, chest expansion at the level of the axilla ( p  < 0.05) and 6MWD ( p  < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p  > 0.05).","[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Al Hosn One Day Surgery Center LLC, Al Sahel Tower Building, Post Box 37384, Abu Dhabi, UAE.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Ganai', 'Affiliation': 'Department of Rehabilitation Sciences, Jamia Hamdard, New Delhi 110062, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': 'Neuro-Physiotherapy Unit, NSC, All India Institute of Medical Sciences, New Delhi 110029, India.'}, {'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Zaheen A', 'Initials': 'ZA', 'LastName': 'Iqbal', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186480']
2261,32899926,"Effect of a Concurrent Cognitive Task, with Stabilizing Visual Information and Withdrawal, on Body Sway Adaptation of Parkinsonian's Patients in an Off-Medication State: A Controlled Study.","Background : In persons with Parkinson's disease (pwPD) any additional somatosensory or distractor interference can influence the posture. When deprivation of vision and dual-task are associated, the effect on biomechanical performance is less consistent. The aim of this study was to evaluate the role of the visual deprivation and a cognitive task on the static balance in earlier stage PD subjects.  Methods:  Fifteen off-medication state pwPD (9 women and 6 men), 67.7 ± 7.3 years old, diagnosed PD since 5.4 ± 3.4 years, only Hoehn and Yahr state 2 and fifteen young control adults (7 women and 8 men) aged 24.9 ± 4.9 years, performed semi-tandem task under four randomized experimental conditions: eyes opened single-task, eyes closed single-task, eyes opened dual-task and eyes closed dual-task. The center of pressure (COP) was measured using a force plate and electromyography signals (EMG) of the ankle/hip muscles were recorded. Traditional parameters, including COP pathway length, ellipse area, mediolateral/anteroposterior root-mean-square and non-linear measurements were computed. The effect of vision privation, cognitive task, and vision X cognitive was investigated by a 2 (eyes opened/eyes closed) × 2 (postural task alone/with cognitive task) repeated-measures ANOVA after application of a Bonferroni pairwise correction for multiple comparisons. Significant interactions were further analyzed using post-hoc tests.  Results : In pwPD, both COP pathway length ( p  < 0.01), ellipse area ( p  < 0.01) and mediolateral/anteroposterior root-mean-square ( p  < 0.01) were increased with the eyes closed, while the dual-task had no significant effect when compared to the single-task condition. Comparable results were observed in the control group for who COP pathway was longer in all conditions compared to eyes opened single-task ( p  < 0.01) and longer in conditions with eyes closed compared to eyes opened dual-task ( p  < 0.01). Similarly, all differences in EMG activity of pwPD were exclusively observed between eyes opened vs. eyes closed conditions, and especially for the forward leg's soleus ( p  < 0.01) and backward tibialis anterior ( p  < 0.01).  Conclusions : These results in pwPD without noticeable impairment of static balance encourage the assessment of both visual occlusion and dual-task conditions when the appearance of significant alteration during the dual-task could reveal the subtle worsening onset of the balance control.",2020,Comparable results were observed in the control group for who COP pathway was longer in all conditions compared to eyes opened single-task ( p  < 0.01) and longer in conditions with eyes closed compared to eyes opened dual-task ( p  < 0.01).,"['Methods:  Fifteen off-medication state pwPD (9 women and 6 men), 67.7 ± 7.3 years old, diagnosed PD since 5.4 ± 3.4 years, only Hoehn and Yahr state 2 and fifteen young control adults (7 women and 8 men) aged 24.9 ± 4.9 years, performed semi-tandem task under four randomized experimental conditions: eyes', 'earlier stage PD subjects', ""Parkinsonian's Patients in an Off-Medication State"", ""persons with Parkinson's disease (pwPD""]","['× 2 (postural task alone/with cognitive task', ' ', 'vision privation, cognitive task, and vision X cognitive was investigated by a 2 (eyes opened/eyes closed', 'Concurrent Cognitive Task, with Stabilizing Visual Information and Withdrawal', 'opened single-task, eyes closed single-task, eyes opened dual-task and eyes closed dual-task']","['backward tibialis anterior', 'COP pathway length', 'static balance', 'center of pressure (COP', 'EMG activity of pwPD', 'COP pathway length, ellipse area, mediolateral/anteroposterior root-mean-square and non-linear measurements', 'Body Sway Adaptation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0033179', 'cui_str': 'Privation'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",7.0,0.0138443,Comparable results were observed in the control group for who COP pathway was longer in all conditions compared to eyes opened single-task ( p  < 0.01) and longer in conditions with eyes closed compared to eyes opened dual-task ( p  < 0.01).,"[{'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Delafontaine', 'Affiliation': 'CIAMS, University Paris-Sud, Université Paris-Saclay, 91405 Orsay, France.'}, {'ForeName': 'Clint', 'Initials': 'C', 'LastName': 'Hansen', 'Affiliation': 'Department of Neurology, University Hospital Schleswig-Holstein, Christian-Albrechts-Universität zu Kiel, 24098 Kiel, Germany.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Marolleau', 'Affiliation': 'CIAMS, University Paris-Sud, Université Paris-Saclay, 91405 Orsay, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kratzenstein', 'Affiliation': 'CAU Motion Lab, Kiel University, Olshausenstraße 74, 24098 Kiel, Germany.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gouelle', 'Affiliation': 'ProtoKinetics, Havertown, PA 19083, USA.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185059']
2262,32900220,Randomised controlled trial of integrated cognitive behavioural treatment and motivational enhancement for comorbid social anxiety and alcohol use disorders.,"OBJECTIVE


Alcohol use disorder and social anxiety disorder are interconnected disorders that commonly co-occur. We report the first trial to assess whether integrated treatment for social anxiety and alcohol use disorder comorbidity improves outcomes relative to standard alcohol-focussed treatment.
METHOD


Participants were recruited to a randomised controlled trial, and randomly allocated to one of two treatments, Integrated ( n  = 61) or Control (alcohol-focussed;  n  = 56). Assessment and treatment session were conducted at two sites in Sydney, Australia. Inclusion criteria were as follows: (1) clinical diagnosis of social anxiety disorder and (2) Diagnosis or sub-clinical symptoms of alcohol use disorder. Diagnoses were determined according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.). All participants ( n  = 117) received 10 sessions of cognitive behavioural treatment and motivational enhancement. The Integrated treatment simultaneously targeted social anxiety disorder, alcohol use disorder and the connections between these disorders. The Control treatment focussed on alcohol use disorder only. Outcomes were assessed at 6-month follow-up, with interim assessments at post-treatment and 3 months. Primary outcomes were social anxiety disorder severity (composite Social Phobia Scale and Social Interaction Anxiety Scale), alcohol use disorder severity (standard drinks per day and Severity of Alcohol Dependence Questionnaire) and quality of life (Short-Form Health survey) was assessed to capture the combined impairment of social anxiety and alcohol use disorder comorbidity.
RESULTS


At 6-month follow-up, both conditions showed significant reductions in social anxiety and alcohol use disorder symptoms, and improved quality of life. There was no evidence of between-condition differences for alcohol outcomes, with mean consumption reduced by 5.0 (0.8) and 5.8 (1.0) drinks per day following Alcohol and Integrated treatments, respectively. Integrated treatment achieved greater improvements in social anxiety symptoms (mean difference = -14.9, 95% confidence interval = [-28.1, -1.6],  d   =  0.60) and quality of life (mean difference = 7.6, 95% confidence interval = [1.2, 14.0],  d   =  0.80) relative to alcohol-focused treatment.
CONCLUSION


These results suggest that integrated social anxiety and alcohol use disorder treatment enhances quality of life and social anxiety disorder symptom improvement, but not alcohol outcomes, compared to treatment focussed on alcohol use disorder alone.",2020,"Integrated treatment achieved greater improvements in social anxiety symptoms (mean difference = -14.9, 95% confidence interval = [-28.1, -1.6],  d   =  0.60) and quality of life (mean difference = 7.6, 95% confidence interval = [1.2, 14.0],  d   =  0.80) relative to alcohol-focused treatment.
","['Participants', 'comorbid social anxiety and alcohol use disorders', 'All participants ( n \u2009=\u2009117) received']","['Control (alcohol-focussed;  n \u2009=\u200956', 'integrated cognitive behavioural treatment and motivational enhancement', 'standard alcohol-focussed treatment', '10 sessions of cognitive behavioural treatment and motivational enhancement']","['social anxiety disorder severity (composite Social Phobia Scale and Social Interaction Anxiety Scale), alcohol use disorder severity (standard drinks per day and Severity of Alcohol Dependence Questionnaire) and quality of life (Short-Form Health survey', 'quality of life and social anxiety disorder symptom improvement', 'social anxiety symptoms', 'mean consumption', 'social anxiety and alcohol use disorder comorbidity', 'social anxiety and alcohol use disorder symptoms, and improved quality of life', 'quality of life']","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0451470', 'cui_str': 'Severity of alcohol dependence questionnaire'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]",,0.0181574,"Integrated treatment achieved greater improvements in social anxiety symptoms (mean difference = -14.9, 95% confidence interval = [-28.1, -1.6],  d   =  0.60) and quality of life (mean difference = 7.6, 95% confidence interval = [1.2, 14.0],  d   =  0.80) relative to alcohol-focused treatment.
","[{'ForeName': 'Lexine A', 'Initials': 'LA', 'LastName': 'Stapinski', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Sannibale', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Mirjana', 'Initials': 'M', 'LastName': 'Subotic', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre of Research in Mental Health and Substance Use, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Haber', 'Affiliation': 'Discipline of Addiction Medicine, The University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Baillie', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420952539']
2263,32900246,A randomized placebo-controlled study investigating the efficacy of inspiratory muscle training in the treatment of children with bronchial asthma.,"Objective:  To investigate the efficacy of inspiratory muscle training (IMT) on respiratory functions, respiratory muscle strength, and asthma symptoms in asthmatic children. Methods:  In a randomized placebo-controlled assessor-blinded study, 34 children with asthma were randomized to receive either the IMT at 40% of the maximal inspiratory pressure (IP max ) for 20 minutes/session, thrice/week, over 12 consecutive weeks (IMT group;  n  = 17) or placebo IMT at 5% of IP max  (placebo group;  n  = 17). Additionally, both groups received the conventional respiratory rehabilitation (CRR) program. Outcome measurements performed pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV 1 ), forced vital capacity (FEV), and FEV 1 /FVC], respiratory muscle strength [represented by IP max  and maximal expiratory pressure (EP max ), and asthma control test (ACT). Results:  At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC ( P =.004), IP max  ( P =.002), EP max  ( P =.004), and ACT ( P =.001) adjusted to the pre-treatment values, in favor of the IMT group. Conclusion:  Incorporation of IMT in the CRR program for children with asthma can improve respiratory function, enhance respiratory muscle strength, and improve children's perception of asthma symptoms.",2020,"At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC","['34 children with asthma', 'children with asthma', 'children with bronchial asthma', 'asthmatic children']","['IMT', 'inspiratory muscle training (IMT', 'conventional respiratory rehabilitation (CRR) program', 'placebo', 'inspiratory muscle training', 'maximal inspiratory pressure (IP max ', 'placebo IMT at 5% of IP max  (placebo']","['FEV 1 /FVC', 'EP max', ""children's perception of asthma symptoms"", 'pre- and post-treatment, included respiratory functions [forced expiratory volume at the first second (FEV 1 ), forced vital capacity (FEV), and FEV 1 /FVC], respiratory muscle strength [represented by IP max  and maximal expiratory pressure (EP max ), and asthma control test (ACT', 'respiratory functions, respiratory muscle strength, and asthma symptoms', 'FVC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",34.0,0.139749,"At a significance level adjusted to  P <.008, there were significant post-treatment differences between the IMT and placebo groups in FEV 1  ( P =.003), FVC ( P =.001), FEV 1 /FVC","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, Collage of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1821058']
2264,32900257,The Effectiveness of Jet (Needle-Free) Injector to Provide Anesthesia in Child Circumcision under Local Anesthesia.,"OBJECTIVE


In our study, we aimed to evaluate the effectiveness of a needle-free (jet) injector in local anesthesia for circumcision.
MATERIALS AND METHODS


A total of 64 children were divided into two groups as jet injector group (n = 32) and conventional needle group (n = 32). Ring block was applied 6-8 times with a jet injector that sprayed each time 0.1 ml (2 mg) of lidocaine in jet injector group. In conventional needle group, ring block was applied with 2 mg/kg lidocaine injection. Using FLACC (Face, Legs, Activity, Cry, Consolability) pain scale, pain score during local anesthetic injection, anesthesia start time and pain score during circumcision were determined for both groups.
RESULTS


The mean age of the patients was 3.99 ± 1.41 years in jet injector group and 3.88 ± 1.33 years in conventional needle group. The mean FLACC pain score during the anesthesia procedure was 4.75 ± 0.25 in jet injector group, while it was 7.06 ± 0.24 in conventional needle group. FLACC pain scores were found to be significantly lower in jet injector group ( p  = 0.0001). During circumcision, the mean FLACC scores were 4.91 ± 0.29 and 2.31 ± 0.18 for jet injector group and conventional needle group, respectively. These FLACC pain scores were found to be significantly lower in conventional needle group ( p  = 0.0001).
CONCLUSION


Our study showed that anesthesia using a jet injector can not provide sufficient analgesia so as to comfortably complete circumcision in pediatric circumcisions performed under local anesthesia.",2020,FLACC pain scores were found to be significantly lower in jet injector group ( p  = 0.0001).,"['Child Circumcision under Local Anesthesia', 'The mean age of the patients was 3.99\u2009±\u20091.41\u2009years in jet injector group and 3.88\u2009±\u20091.33\u2009years in conventional needle group', '64 children']","['Jet (Needle-Free) Injector to Provide Anesthesia', 'needle-free (jet) injector', 'conventional needle group', 'lidocaine injection', 'lidocaine']","['FLACC pain scores', 'mean FLACC scores', 'mean FLACC pain score', 'FLACC (Face, Legs, Activity, Cry, Consolability) pain scale, pain score during local anesthetic injection, anesthesia start time and pain score during circumcision']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708662', 'cui_str': '3.99'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3888433', 'cui_str': 'Jet Injector'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517500', 'cui_str': '1.33'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0181342', 'cui_str': 'Injector'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4049857', 'cui_str': 'Lidocaine Injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1301945', 'cui_str': 'Anesthesia start time'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}]",64.0,0.0151715,FLACC pain scores were found to be significantly lower in jet injector group ( p  = 0.0001).,"[{'ForeName': 'Osman', 'Initials': 'O', 'LastName': 'Akyüz', 'Affiliation': 'Department of Urology, School of Medicine, Atlas University, Istanbul, Turkey.'}, {'ForeName': 'Müslüm', 'Initials': 'M', 'LastName': 'Ergün', 'Affiliation': 'Department of Urology, School of Medicine, Atlas University, Istanbul, Turkey.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1817635']
2265,32900264,Association of Alcohol Intake With Hypertension in Type 2 Diabetes Mellitus: The ACCORD Trial.,"Background Heavy alcohol consumption has a well-established association with hypertension. However, doubt persists whether moderate alcohol consumption has a similar link. This relationship is not well-studied in patients with diabetes mellitus. We aimed to describe the association of alcohol consumption with prevalent hypertension in participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial. Methods and Results Alcohol consumption was categorized as none, light (1-7 drinks/week), moderate (8-14 drinks/week), and heavy (≥15 drinks/week). Blood pressure was categorized using American College of Cardiology/American Heart Association guidelines as normal, elevated blood pressure, stage 1 hypertension, and stage 2 hypertension. Multivariable logistic regression was used to explore the association between alcohol consumption and prevalent hypertension. A total of 10 200 eligible participants were analyzed. Light alcohol consumption was not associated with elevated blood pressure or any stage hypertension. Moderate alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (odds ratio [OR], 1.79; 95% CI, 1.04-3.11,  P =0.03; OR, 1.66; 95% CI, 1.05-2.60,  P =0.03; and OR, 1.62; 95% CI, 1.03-2.54,  P =0.03, respectively). Heavy alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (OR, 1.91; 95% CI, 1.17-3.12,  P =0.01; OR, 2.49; 95% CI, 1.03-6.17,  P =0.03; and OR, 3.04; 95% CI, 1.28-7.22,  P =0.01, respectively). Conclusions Despite prior research, our findings show moderate alcohol consumption is associated with hypertension in patients with type 2 diabetes mellitus and elevated cardiovascular risk. We also note a dose-risk relationship with the amount of alcohol consumed and the degree of hypertension.",2020,"Heavy alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (OR, 1.91; 95% CI, 1.17-3.12,  P =0.01; OR, 2.49; 95% CI, 1.03-6.17,  P =0.03; and OR, 3.04; 95% CI, 1.28-7.22,  P =0.01, respectively).","['patients with type 2 diabetes mellitus and elevated cardiovascular risk', 'Type 2 Diabetes Mellitus', 'A total of 10\xa0200 eligible participants were analyzed', 'prevalent hypertension in participants in the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial', 'patients with diabetes mellitus']","['Alcohol Intake With Hypertension', ' Heavy alcohol consumption']","['elevated blood pressure or any stage hypertension', 'Moderate alcohol consumption', 'elevated blood pressure, stage 1, and stage 2 hypertension', 'Blood pressure', 'Heavy alcohol consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]",10200.0,0.0573236,"Heavy alcohol consumption was associated with elevated blood pressure, stage 1, and stage 2 hypertension (OR, 1.91; 95% CI, 1.17-3.12,  P =0.01; OR, 2.49; 95% CI, 1.03-6.17,  P =0.03; and OR, 3.04; 95% CI, 1.28-7.22,  P =0.01, respectively).","[{'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Mayl', 'Affiliation': 'Section of Internal Medicine Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'German', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Department of Epidemiology and Prevention Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Upadhya', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Prashant D', 'Initials': 'PD', 'LastName': 'Bhave', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Yeboah', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Singleton', 'Affiliation': 'Section of Cardiology Department of Internal Medicine Wake Forest School of Medicine Winston-Salem NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017334']
2266,32900266,"Anxiolytic effects of acute and maintenance ketamine, as assessed by the Fear Questionnaire subscales and the Spielberger State Anxiety Rating Scale.","BACKGROUND


Ketamine has rapid anxiolytic effects in treatment-resistant obsessive compulsive, post-traumatic stress, generalised anxiety and social anxiety disorders.
OBJECTIVES


This study aimed to assess changes following acute and maintenance ketamine therapy on the Fear Questionnaire (FQ) subscales and the Spielberger State Anxiety Inventory (SSAI).
METHODS


This secondary analysis used data from a mixed open-label and double-blinded placebo-controlled study. A total of 24 patients received short-term ascending subcutaneous doses of ketamine and were then eligible to enter a 3-month maintenance phase of 1 mg/kg ketamine dosed once or twice weekly. FQ and SSAI data were analysed using mixed models to identify between-dose differences and to describe trends during maintenance.
RESULTS


Acute ketamine dosing showed a rapid dose-related reduction in all three FQ subscales (agoraphobia, social phobia and blood-injury phobia) and in the SSAI. A progressive decrease in pre-dose rating-scale scores was evident during the 3 months of maintenance therapy.
CONCLUSIONS


Ketamine demonstrated dose-related improvements in all FQ subscales and in the SSAI. Both scales appear to be suitable tools to assess the anxiolytic effects of ketamine in patients with treatment-resistant anxiety. Furthermore, ketamine appears to have broad, dose-related anti-phobic effects. These findings raise the possibility that ketamine may have therapeutic potential in the treatment of other phobic states, such as specific phobia.",2020,"RESULTS


Acute ketamine dosing showed a rapid dose-related reduction in all three FQ subscales (agoraphobia, social phobia and blood-injury phobia) and in the SSAI.","['24 patients received', 'patients with treatment-resistant anxiety']","['ketamine', 'short-term ascending subcutaneous doses of ketamine', 'Ketamine']","['anxiolytic effects', 'Fear Questionnaire subscales and the Spielberger State Anxiety Rating Scale', 'pre-dose rating-scale scores', 'FQ subscales (agoraphobia, social phobia and blood-injury phobia', 'FQ subscales', 'Fear Questionnaire (FQ) subscales and the Spielberger State Anxiety Inventory (SSAI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C3179404', 'cui_str': 'Anti-Anxiety Effects'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0349231', 'cui_str': 'Phobia'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",24.0,0.0250586,"RESULTS


Acute ketamine dosing showed a rapid dose-related reduction in all three FQ subscales (agoraphobia, social phobia and blood-injury phobia) and in the SSAI.","[{'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Truppman Lattie', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Nehoff', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Shona', 'Initials': 'S', 'LastName': 'Neehoff', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': ""Biostatistics Unit, Dean's Office, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Glue', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120953991']
2267,32900325,The cost-effectiveness of adjunctive corticosteroids for patients with septic shock.,"OBJECTIVE


To determine whether hydrocortisone is a cost-effective treatment for patients with septic shock.
DESIGN


Data linkage-based cost-effectiveness analysis.
SETTING


New South Wales and Queensland intensive care units.
PARTICIPANTS AND INTERVENTION


Patients with septic shock randomly assigned to treatment with hydrocortisone or placebo in the Adjunctive Glucocorticoid Therapy in Patients with Septic Shock (ADRENAL) trial.
MAIN OUTCOME MEASURES


Health-related quality of life at 6 months using the EuroQoL 5-dimension 5-level questionnaire. Data on hospital resource use and costs were obtained by linking the ADRENAL dataset to government administrative health databases. Clinical outcomes included mortality, health-related quality of life, and quality-adjusted life-years gained; economic outcomes included hospital resource use, costs and cost-effectiveness from the health care payer perspective. We also assessed cost-effectiveness by sex. To increase the precision of cost-effectiveness estimates, we conducted unrestricted bootstrapping.
RESULTS


Of 3800 patients in the ADRENAL trial, 1772 (46.6%) were eligible and 1513 (85.4% of those eligible) were included. There was no difference between hydrocortisone or placebo groups in regards to mortality (218/742 [29.4%]  v  227/759 [29.9%]; HR, 0.93; 95% CI, 0.78-1.12;  P  = 0.47), mean number of QALYs gained (0.10 ± 0.09  v  0.10 ± 0.09;  P  = 0.52), or total hospital costs (A$73 515 ± 61 376  v  A$69 748 ± 61 793; mean difference, A$3767; 95% CI, -A$2891 to A$10 425;  P  = 0.27). The incremental cost of hydrocortisone was A$1 254 078 per quality-adjusted life-year gained. In females, hydrocortisone was cost-effective in 46.2% of bootstrapped replications and in males it was cost-effective in 2.7% of bootstrapped replications.
CONCLUSIONS


Adjunctive hydrocortisone did not significantly affect longer term mortality, health-related quality of life, health care resource use or costs, and is unlikely to be cost-effective.",2020,"There was no difference between hydrocortisone or placebo groups in regards to mortality (218/742 [29.4%]  v  227/759 [29.9%]; HR, 0.93; 95% CI, 0.78-1.12;  P  = 0.47), mean number of QALYs gained (0.10 ± 0.09  v  0.10 ± 0.09;  P  = 0.52), or total hospital costs (A$73 515 ± 61 376  v  A$69 748 ±","['patients with septic shock', 'New South Wales and Queensland intensive care units', 'Patients with septic shock randomly assigned to treatment with', 'Of 3800 patients in the ADRENAL trial, 1772 (46.6%) were eligible and 1513 (85.4% of those eligible) were included', 'Patients with Septic Shock (ADRENAL) trial']","['hydrocortisone or placebo', 'placebo', 'adjunctive corticosteroids', 'hydrocortisone', 'Adjunctive Glucocorticoid Therapy']","['cost-effectiveness', 'total hospital costs', 'mortality, health-related quality of life, and quality-adjusted life-years gained; economic outcomes included hospital resource use, costs and cost-effectiveness from the health care payer perspective', 'Health-related quality of life at 6 months using the EuroQoL 5-dimension 5-level questionnaire', 'precision of cost-effectiveness estimates', 'term mortality, health-related quality of life, health care resource use or costs', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.331299,"There was no difference between hydrocortisone or placebo groups in regards to mortality (218/742 [29.4%]  v  227/759 [29.9%]; HR, 0.93; 95% CI, 0.78-1.12;  P  = 0.47), mean number of QALYs gained (0.10 ± 0.09  v  0.10 ± 0.09;  P  = 0.52), or total hospital costs (A$73 515 ± 61 376  v  A$69 748 ±","[{'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Thompson', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia. kthompson@georgeinstitute.org.'}, {'ForeName': 'Colman B', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Naomi E', 'Initials': 'NE', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Myburgh', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Dorrilyn', 'Initials': 'D', 'LastName': 'Rajbhandari', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Saxena', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Ashwani', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Finfer', 'Affiliation': 'The George Institute for Global Health, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
2268,32900329,"Cytokine and lipid metabolome effects of low-dose acetylsalicylic acid in critically ill patients with systemic inflammation: a pilot, feasibility, multicentre, randomised, placebo-controlled trial.","OBJECTIVE


The systemic inflammatory response syndrome (SIRS) is a dysregulated response that contributes to critical illness. Adjunctive acetylsalicylic acid (ASA) treatment may offer beneficial effects by increasing the synthesis of specialised proresolving mediators (a subset of polyunsaturated fatty acid-derived lipid mediators).
DESIGN


Pilot, feasibility, multicentre, double-blind, randomised, placebo-controlled trial.
SETTING


Four interdisciplinary intensive care units (ICUs) in Australia.
PARTICIPANTS


Critically ill patients with SIRS.
INTERVENTIONS


ASA 100 mg 12-hourly or placebo, administered within 24 hours of ICU admission and continued until ICU day 7, discharge or death, whichever came first.
MAIN OUTCOME MEASURES


Interleukin-6 (IL-6) serum concentration at 48 hours after randomisation and, in a prespecified subgroup of patients, serum lipid mediator concentrations measured by mass spectrometry.
RESULTS


The trial was discontinued in December 2017 due to slow recruitment and after the inclusion of 48 patients. Compared with placebo, ASA did not decrease IL-6 serum concentration at 48 hours. In the 32 patients with analysis of lipid mediators, low-dose ASA increased the concentration of 15-hydroxyeicosatetraenoic acid, a proresolving precursor of lipoxin A4, and reduced the concentration of the proinflammatory cytochrome P-dependent mediators 17-HETE (hydroxyeicosatetraenoic acid), 18-HETE and 20-HETE. In the eicosapentaenoic acid pathway, ASA significantly increased the concentration of the anti-inflammatory mediators 17,18-DiHETE (dihydroxyeicosatetraenoic acid) and 14,15-DiHETE.
CONCLUSIONS


In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators. The ability to measure lipid mediators in clinical samples and to monitor the effect of ASA on their levels unlocks a potential area of biological investigation in critical care.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN 12614001165673).",2020,"In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators.","['Four interdisciplinary intensive care units (ICUs) in Australia', 'December 2017 due to slow recruitment and after the inclusion of 48 patients', 'Critically ill patients with SIRS', 'critically ill patients with systemic inflammation']","['low-dose acetylsalicylic acid', 'Adjunctive acetylsalicylic acid (ASA', 'placebo, ASA', 'placebo', 'ASA 100 mg 12-hourly or placebo']","['serum IL-6 concentrations', 'concentration of the anti-inflammatory mediators 17,18-DiHETE (dihydroxyeicosatetraenoic acid) and 14,15-DiHETE', 'Interleukin-6 (IL-6) serum concentration', 'serum lipid mediator concentrations', 'IL-6 serum concentration', 'concentration of 15-hydroxyeicosatetraenoic acid', 'plasma concentrations of certain lipid mediators']","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0020349', 'cui_str': 'Hydroxyeicosatetraenoic acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.742564,"In ICU patients with SIRS, low-dose ASA did not significantly alter serum IL-6 concentrations, but it did affect plasma concentrations of certain lipid mediators.","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia. luca.cioccari@insel.ch.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Thy', 'Initials': 'T', 'LastName': 'Duong', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'School of Chemistry, Bio21 Molecular Science and Biotechnology Institute, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Salvatore L', 'Initials': 'SL', 'LastName': 'Cutuli', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Patryck', 'Initials': 'P', 'LastName': 'Lloyd-Donald', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Eastwood', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Peck', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Young', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Suvi T', 'Initials': 'ST', 'LastName': 'Vaara', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'French', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Orford', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Jyotsna', 'Initials': 'J', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Intensive Care, Bankstown Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Yugeesh R', 'Initials': 'YR', 'LastName': 'Lankadeva', 'Affiliation': 'Preclinical Critical Care Unit, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Vic, Australia.'}, {'ForeName': 'Gavin E', 'Initials': 'GE', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Melbourne, Melbourne, Vic, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia.'}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
2269,32900336,Sodium bicarbonate therapy for metabolic acidosis in critically ill patients: a survey of Australian and New Zealand intensive care clinicians.,"OBJECTIVE


To help shape the design of a future double blind placebo-controlled randomised clinical trial of bicarbonate therapy for metabolic acidosis, based on opinions of intensive care clinicians in Australia and New Zealand.
DESIGN


An online survey was designed, piloted and distributed electronically to members of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) mailing list. The survey sought to collect information about choice of placebo, method of bicarbonate administration, and acid-base monitoring.
MAIN OUTCOME MEASURES


Responses to six questions in the following domains were sought: 1) solution to be used as placebo; 2) method of administration; 3) target of the intervention; 4) timing of arterial blood gases to monitor the intervention; 5) duration of therapy; and 6) rate of bolus therapy (if selected as the best option).
RESULTS


One in every eight ANZICS CTG members completed the survey (118/880, 13.4%). Compound sodium lactate was the preferred solution for placebo (54/118, 45.8%), and continuous infusion of bicarbonate (80/118, 67.8%) was the most frequently selected method of administration. A pH > 7.30 was the preferred target (50/118, 42.4%), while monitoring with arterial blood gas analysis every 2 hours until the target is reached and then every 4 hours was the most favoured option (40/118, 33.9%). The preferred duration of therapy was until the target is achieved (53/118, 44.9%).
CONCLUSIONS


This survey offers important insights into the preferences of Australian and New Zealand clinicians in regards to any future randomised controlled trial of bicarbonate therapy for metabolic acidosis in the critically ill.",2020,"Compound sodium lactate was the preferred solution for placebo (54/118, 45.8%), and continuous infusion of bicarbonate (80/118, 67.8%) was the most frequently selected method of administration.","['intensive care clinicians in Australia and New Zealand', 'critically ill patients']","['Compound sodium lactate', 'bicarbonate therapy', 'Sodium bicarbonate therapy', 'placebo, method of bicarbonate administration, and acid-base monitoring', 'placebo', 'bicarbonate']",['arterial blood gases to monitor the intervention; 5) duration of therapy; and 6) rate of bolus therapy (if selected as the best option'],"[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0142874', 'cui_str': 'Sodium lactate'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1270997', 'cui_str': 'Acid-base balance monitoring'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.238844,"Compound sodium lactate was the preferred solution for placebo (54/118, 45.8%), and continuous infusion of bicarbonate (80/118, 67.8%) was the most frequently selected method of administration.","[{'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia. ary.serpaneto@monash.edu.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'El-Khawas', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Udy', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre; Monash University, Melbourne, VIC, Australia.'}]",Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine,[]
2270,32900361,The relationship between the level of μ-opioid receptor (μORs) and postoperative analgesic use in patients undergoing septoplasty: a prospective randomized controlled trial.,"BACKGROUND


In this study, the μ-Opioid receptor activity was assessed pre-operatively for its association with postoperative pain level and second analgesic requirement in patients undergoing septoplasty.
METHODS


In our prospective study, 120 adult patients underwent septoplasty from June 2015 to January 2019 were randomly divided into 2 pre-operative groups. The first group (n = 60) was patients given tramadol (1-2 mg/kg) for post-operative analgesia, and the second group (control group) (n = 60) was initially prescribed only fentanyl (1 μg/ kg-i.v.) in the induction. Acetaminophen with codeine analgesic 325/30 mg (p.o.) was used as an rescue painkiller in the post-operative period. The μ-Opioid receptor activity was investigated in pre-operative blood samples and compared to post-operative pain level and time required for second round of analgesic administration. The visual analogue score (VAS) was used to evaluate the post-operative pain degree (0 no pain; 10 worst pain). The patients' post-operative VAS scores were evaluated upon arrival to recovery room, and at the 1st, 3rd, 7th, 10th, and 24th hour post-operative period.
RESULTS


Demographic data and peri-operative variables were similar in both study group (p < 0.05).There was no significant difference between the receptor levels in both groups and the mean receptor level was 200.94 ± 15.34 pg/mL (max:489.92 ± 22.36 pg/mL, min: 94.56 ± 11.23 pg/mL).In patients who used tramadol as the levels of μ-Opioid receptors increased, VAS scores of patients and second analgesic use decreased in post-operative period.The VAS scores in patients with higher receptor levels were lower in the recovery room (p < 0.05), 1st (p < 0.05) and 3rd hours (p < 0.05).The VAS scores were lower in the tramadol group compared to the control group (p < 0.05).Number of secondary analgesic requirement was significantly lower in patients of the tramadol group with higher receptor levels compared to the ones with lower receptor (p < 0.05) for arrival at the recovery room and 1st hour. Patients in the tramadol group needed a second pain killer much later than patients in the control group.
CONCLUSIONS


Our study demonstrates that patients with higher μOR levels have a higher efficacy of opioid analgesic agents and an lesser need for additional analgesic agents.
TRIAL REGISTRATION


This trial was registered retrospectively (The ACTRN: ACTRN12619001652167 , registration date: 26/11/2019).",2020,(p < 0.05).The VAS scores were lower in the tramadol group compared to the control group (p < 0.05).Number of secondary analgesic requirement was significantly lower in patients of the tramadol group with higher receptor levels compared to the ones with lower receptor (p < 0.05) for arrival at the recovery room and 1st hour.,"['120 adult patients underwent septoplasty from June 2015 to January 2019', 'patients with higher μOR levels', 'patients undergoing septoplasty']","['tramadol', 'Acetaminophen', 'codeine analgesic 325/30']","['receptor levels', 'operative VAS scores', 'μ-Opioid receptor activity', 'mean receptor level', 'VAS scores', 'visual analogue score (VAS']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0009214', 'cui_str': 'Codeine'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034801', 'cui_str': 'Opioid Receptor'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.0335004,(p < 0.05).The VAS scores were lower in the tramadol group compared to the control group (p < 0.05).Number of secondary analgesic requirement was significantly lower in patients of the tramadol group with higher receptor levels compared to the ones with lower receptor (p < 0.05) for arrival at the recovery room and 1st hour.,"[{'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Gencer', 'Affiliation': 'Department of Anesthesia, Istinye University Medical Faculty, Istanbul, Turkey. dr.m.gencer07@gmail.com.'}, {'ForeName': 'Ayşe Yeşim', 'Initials': 'AY', 'LastName': 'Göçmen', 'Affiliation': 'Department of Biochemistry, Bozok University Medical Faculty, Yozgat, Turkey.'}]",BMC anesthesiology,['10.1186/s12871-020-01138-z']
2271,32900372,Treatment estimands in clinical trials of patients hospitalised for COVID-19: ensuring trials ask the right questions.,"When designing a clinical trial, explicitly defining the treatment estimands of interest (that which is to be estimated) can help to clarify trial objectives and ensure the questions being addressed by the trial are clinically meaningful. There are several challenges when defining estimands. Here, we discuss a number of these in the context of trials of treatments for patients hospitalised with COVID-19 and make suggestions for how estimands should be defined for key outcomes. We suggest that treatment effects should usually be measured as differences in proportions (or risk or odds ratios) for outcomes such as death and requirement for ventilation, and differences in means for outcomes such as the number of days ventilated. We further recommend that truncation due to death should be handled differently depending on whether a patient- or resource-focused perspective is taken; for the former, a composite approach should be used, while for the latter, a while-alive approach is preferred. Finally, we suggest that discontinuation of randomised treatment should be handled from a treatment policy perspective, where non-adherence is ignored in the analysis (i.e. intention to treat).",2020,"We suggest that treatment effects should usually be measured as differences in proportions (or risk or odds ratios) for outcomes such as death and requirement for ventilation, and differences in means for outcomes such as the number of days ventilated.","['patients hospitalised for COVID-19', 'patients hospitalised with COVID-19']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],[],,0.0920065,"We suggest that treatment effects should usually be measured as differences in proportions (or risk or odds ratios) for outcomes such as death and requirement for ventilation, and differences in means for outcomes such as the number of days ventilated.","[{'ForeName': 'Brennan C', 'Initials': 'BC', 'LastName': 'Kahan', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK. b.kahan@ucl.ac.uk.'}, {'ForeName': 'Tim P', 'Initials': 'TP', 'LastName': 'Morris', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Conor D', 'Initials': 'CD', 'LastName': 'Tweed', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Cro', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'HRB Clinical Research Facility Cork, Cork, Ireland.'}, {'ForeName': 'Tra My', 'Initials': 'TM', 'LastName': 'Pham', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Hanif', 'Initials': 'H', 'LastName': 'Esmail', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Babiker', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Carpenter', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}]",BMC medicine,['10.1186/s12916-020-01737-0']
2272,32900508,"Intrathecal morphine and sleep apnoea severity in patients undergoing hip arthroplasty: a randomised, controlled, triple-blinded trial.","BACKGROUND


Intrathecal morphine prolongs analgesia after surgery, but has been implicated in postoperative respiratory depression or apnoeic episodes. However, this has not been investigated in a prospective trial using respiratory polygraphy. This randomised controlled triple-blinded trial tested the hypothesis that intrathecal morphine increases sleep apnoea severity, measured using respiratory polygraphy.
METHODS


Sixty subjects undergoing hip arthroplasty under spinal anaesthesia received either 15 mg isobaric bupivacaine 0.5% with 0.5 ml normal saline 0.9% (control group) or 15 mg isobaric bupivacaine 0.5% with 0.5 ml intrathecal morphine 100 μg (intrathecal morphine group). Respiratory polygraphy was performed before surgery and on the first and third postoperative nights. The primary outcome was the apnoea-hypopnoea index in the supine position (supine AHI) on the first postoperative night. Secondary outcomes included supine AHI on the third postoperative night, oxygen desaturation index (ODI), and ventilatory frequency during the first and third postoperative nights.
RESULTS


On the first postoperative night, mean (95% confidence interval) values for supine AHI were 20.6 (13.9-27.3) and 21.2 (12.4-30.0) events h -1  in the control and intrathecal morphine groups, respectively (P=0.90). There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO 2  on the third postoperative night in the control group.
CONCLUSIONS


Intrathecal morphine did not increase sleep apnoea severity when measured using respiratory polygraphy. Of note, all patients had an increased number of apnoeic episodes on the third postoperative night.
CLINICAL TRIAL REGISTRATION


NCT02566226.",2020,"There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO 2  on the third postoperative night in the control group.
","['Sixty subjects undergoing hip arthroplasty under spinal anaesthesia', 'patients undergoing hip arthroplasty']","['Intrathecal morphine', '15 mg isobaric bupivacaine 0.5% with 0.5 ml normal saline 0.9% (control group) or 15 mg isobaric bupivacaine 0.5% with 0.5 ml intrathecal morphine 100 μg (intrathecal morphine', 'intrathecal morphine', 'morphine']","['central and mixed apnoea index', 'sleep apnoea severity', 'supine AHI on the third postoperative night, oxygen desaturation index (ODI), and ventilatory frequency during the first and third postoperative nights', 'number of apnoeic episodes', 'apnoea-hypopnoea index in the supine position (supine AHI) on the first postoperative night']","[{'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",60.0,0.152898,"There were no significant between-group differences for any of the secondary outcomes, except for a significantly higher central and mixed apnoea index preoperatively and significantly lower mean SpO 2  on the third postoperative night in the control group.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Albrecht', 'Affiliation': 'Department of Anaesthesia, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland. Electronic address: eric.albrecht@chuv.ch.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Bayon', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Hirotsu', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Aboud', 'Initials': 'A', 'LastName': ""Al Ja'bari"", 'Affiliation': 'Department of Anaesthesia, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Heinzer', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.052']
2273,32900519,"Long-term effects of resveratrol on cognition, cerebrovascular function and cardio-metabolic markers in postmenopausal women: A 24-month randomised, double-blind, placebo-controlled, crossover study.","Ageing and menopause contribute to endothelial dysfunction, causing impaired cerebral perfusion, which is in turn associated with accelerated cognitive decline. In a 14-week pilot study, we showed that supplementation with low-dose resveratrol, a phytoestrogen that can enhance endothelial function, improved cerebrovascular and cognitive functions in postmenopausal women. We sought to confirm these benefits in a larger, longer-term trial. A 24-month randomized, placebo-controlled crossover trial was undertaken in 125 postmenopausal women, aged 45-85 years, who took 75 mg trans-resveratrol or placebo twice-daily for 12 months and then crossover to the alternative treatment for another 12 months. We evaluated within individual differences between each treatment period in measures of cognition (primary outcome), cerebrovascular function in the middle cerebral artery (cerebral blood flow velocity: CBFV, cerebrovascular responsiveness: CVR) and cardio-metabolic markers as secondary outcomes. Subgroup analyses examined effects of resveratrol by life stages. Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005). Women ≥65 years of age showed a relative improvement in verbal memory with resveratrol compared to those younger than 65 years. Furthermore, resveratrol improved secondary outcomes including resting mean CBFV (d = 0.275, P = 0.001), CVR to hypercapnia (d = 0.307, P = 0.027), CVR to cognitive stimuli (d = 0.259, P = 0.032), fasting insulin (d = 0.174, P = 0.025) and insulin resistance index (d = 0.102, P = 0.034). Regular supplementation with low-dose resveratrol can enhance cognition, cerebrovascular function and insulin sensitivity in postmenopausal women. This may translate into a slowing of the accelerated cognitive decline due to ageing and menopause, especially in late-life women. Further studies are warranted to observe whether these cognitive benefits of resveratrol can reduce the risk of dementia.",2020,"Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005).","['125 postmenopausal women, aged 45-85 years, who took 75\xa0mg trans-resveratrol or placebo twice-daily for 12 months and then crossover to the alternative treatment for another 12 months', 'Women ≥65 years of age', 'postmenopausal women']","['placebo, resveratrol supplementation', 'Regular supplementation with low-dose resveratrol', 'placebo']","['CVR to cognitive stimuli ', 'cognition, cerebrovascular function and cardio-metabolic markers', 'cognition, cerebrovascular function and insulin sensitivity', 'overall cognitive performance', 'CVR to hypercapnia', 'cerebrovascular and cognitive functions', 'resting mean CBFV', 'verbal memory', 'insulin resistance index ', 'cognition (primary outcome), cerebrovascular function in the middle cerebral artery (cerebral blood flow velocity: CBFV, cerebrovascular responsiveness: CVR) and cardio-metabolic markers', 'fasting insulin']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",125.0,0.295164,"Compared to placebo, resveratrol supplementation resulted a significant 33% improvement in overall cognitive performance (Cohen's d = 0.170, P = 0.005).","[{'ForeName': 'Jay Jay', 'Initials': 'JJ', 'LastName': 'Thaung Zaw', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, 2308, Australia.'}, {'ForeName': 'Peter Rc', 'Initials': 'PR', 'LastName': 'Howe', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, 2308, Australia; University of Southern Queensland, Institute for Resilient Regions, Springfield Central, QLD, 4300, Australia; University of South Australia, School of Health Sciences, Adelaide, SA, 5000, Australia.'}, {'ForeName': 'Rachel Hx', 'Initials': 'RH', 'LastName': 'Wong', 'Affiliation': 'University of Newcastle, School of Biomedical Sciences and Pharmacy, Callaghan, NSW, 2308, Australia; University of Southern Queensland, Institute for Resilient Regions, Springfield Central, QLD, 4300, Australia. Electronic address: Rachel.wong@newcastle.edu.au.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.025']
2274,32900520,Dietary stearic acid and palmitic acid do not differently affect ABCA1-mediated cholesterol efflux capacity in healthy men and postmenopausal women: A randomized controlled trial.,"BACKGROUND


The saturated fatty acid stearic acid (C18:0) lowers HDL cholesterol compared with palmitic acid (C16:0). However, the ability of HDL particles to promote cholesterol efflux from macrophages (cholesterol efflux capacity; CEC) may better predict coronary heart disease (CHD) risk than HDL cholesterol concentrations.
OBJECTIVE


We examined effects of exchanging dietary palmitic acid for stearic acid on ATP-binding cassette transporter A1 (ABCA1)-mediated CEC, and other conventional and emerging cardiometabolic risk makers.
DESIGN


In a double-blind, randomized, crossover study with two 4-week isocaloric intervention periods, 34 healthy men and postmenopausal women (61.5 ± 5.7 years, BMI: 25.4 ± 2.5 kg/m 2 ) followed diets rich in palmitic acids or stearic acids. Difference in intakes was 6% of daily energy. ABCA1-mediated CEC was measured from J774 macrophages to apolipoprotein (apo)B-depleted serum.
RESULTS


Compared with the palmitic-acid diet, the stearic-acid diet lowered serum LDL cholesterol (-0.14 mmol/L; p = 0.010), HDL cholesterol (-0.09 mmol/L; p=<0.001), and apoA1 (-0.05 g/L; p < 0.001). ABCA1-mediated CEC did not differ between diets (p = 0.280). Cholesteryl ester transfer protein (CETP) mass was higher on stearic acid (0.11 mg/L; p = 0.003), but CETP activity was comparable. ApoB100 did not differ, but triacylglycerol concentrations tended to be higher on stearic acid (p = 0.100). Glucose concentrations were comparable. Effects on insulin and C-peptide were sex-dependent. In women, the stearic-acid diet increased insulin concentrations (1.57 μU/mL; p = 0.002), while in men, C-peptide concentrations were lower (-0.15 ng/mL; p = 0.037). Interleukin 6 (0.15 pg/mL; p = 0.039) and tumor necrosis factor alpha (0.18 pg/mL; p = 0.005), but not high-sensitivity C-reactive protein, were higher on stearic acid. Soluble intracellular adhesion molecule (9 ng/mL; p = 0.033), but not soluble vascular cell adhesion molecule and endothelial-selectin concentrations decreased after stearic-acid consumption.
CONCLUSIONS


As expected, stearic-acid intake lowered LDL cholesterol, HDL cholesterol, and apoA1. Insulin sensitivity in women and low-grade inflammation might be unfavorably affected by stearic-acid intake. However, palmitic-acid and stearic-acid intakes did not differently affect ABCA1-mediated CEC.
CLINICAL TRIAL REGISTRY


This trial was registered at clinicaltrials.gov as NCT02835651.",2020,"Soluble intracellular adhesion molecule (9 ng/mL; p = 0.033), but not soluble vascular cell adhesion molecule and endothelial-selectin concentrations decreased after stearic-acid consumption.
","['34 healthy men and postmenopausal women (61.5\xa0±\xa05.7 years, BMI: 25.4\xa0±\xa02.5\xa0kg/m 2 ) followed', 'healthy men and postmenopausal women']","['palmitic-acid diet, the stearic-acid diet', 'Dietary stearic acid and palmitic acid', 'saturated fatty acid stearic acid (C18:0', 'diets rich in palmitic acids or stearic acids', 'exchanging dietary palmitic acid', 'palmitic acid (C16:0']","['ABCA1-mediated cholesterol efflux capacity', 'tumor necrosis factor alpha', 'soluble vascular cell adhesion molecule and endothelial-selectin concentrations', 'Cholesteryl ester transfer protein (CETP) mass', 'CETP activity', 'triacylglycerol concentrations', 'HDL cholesterol', 'Soluble intracellular adhesion molecule', 'palmitic-acid and stearic-acid intakes', 'insulin concentrations', 'Insulin sensitivity', 'serum LDL cholesterol', 'LDL cholesterol, HDL cholesterol, and apoA1', 'Glucose concentrations', 'ABCA1-mediated CEC']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0038229', 'cui_str': 'Octadecanoic acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0282651', 'cui_str': 'Selectins'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol ester transfer protein'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0038229', 'cui_str': 'Octadecanoic acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}]",34.0,0.26991,"Soluble intracellular adhesion molecule (9 ng/mL; p = 0.033), but not soluble vascular cell adhesion molecule and endothelial-selectin concentrations decreased after stearic-acid consumption.
","[{'ForeName': 'Merel A', 'Initials': 'MA', 'LastName': 'van Rooijen', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM (School of Nutrition and Translational Research in Metabolism), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Jogchum', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM (School of Nutrition and Translational Research in Metabolism), Maastricht University Medical Center, Maastricht, the Netherlands.'}, {'ForeName': 'Wendy A M', 'Initials': 'WAM', 'LastName': 'Blom', 'Affiliation': 'Unilever Research and Development, Vlaardingen, the Netherlands.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Zock', 'Affiliation': 'Unilever Research and Development, Vlaardingen, the Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM (School of Nutrition and Translational Research in Metabolism), Maastricht University Medical Center, Maastricht, the Netherlands. Electronic address: r.mensink@maastrichtuniversity.nl.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.016']
2275,32900535,Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro (URLi) vs Lispro (Humalog®) Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects.,"PURPOSE


Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetic and glucodynamic parameters of URLi and Lispro (Humalog®) at 3 dose levels in healthy subjects.
METHODS


This randomized, 6-period, subject- and investigator-blind, crossover study included 42 healthy subjects. At each period, subjects received a single subcutaneous dose of 7, 15, or 30 U of URLi or Lispro followed by a 10-h automated euglycemic clamp. Insulin lispro and blood glucose concentrations were measured.
FINDINGS


Across all 3 doses, insulin lispro appeared in the serum 2-5 min faster, and exposure was 6- to 8-fold greater in the first 15 min, with URLi versus Lispro. Exposure beyond 3 h postdose was 45%-52% lower, and duration of exposure was 67-86 min shorter with URLi versus Lispro for all dose levels. Onset of insulin action was 7-9 min faster and insulin action was ~3-fold greater in the first 30 min with URLi versus Lispro across the dose levels. Insulin action beyond 4 h was reduced by 32%-45%, and duration of action was reduced by 47-67 min, with URLi versus Lispro for all 3 dose levels. Overall exposure and total glucose infused were similar between URLi and Lispro at each dose level. Dose proportionality was observed for maximum and overall exposure after URLi. Less than dose-proportional increases in maximum and total glucose infused were observed and were similar for both URLi and Lispro.
IMPLICATIONS


URLi exhibited ultra-rapid pharmacokinetic and glucodynamic parameters across all 3 dose levels studied and exhibited dose-proportional increases in exposure in healthy subjects. ClinicalTrials.gov identifier: NCT03286751.",2020,"Less than dose-proportional increases in maximum and total glucose infused were observed and were similar for both URLi and Lispro.
","['42 healthy subjects', 'healthy subjects', 'Healthy Subjects']","['URLi and Lispro (Humalog®', 'URLi or Lispro followed by a 10-h automated euglycemic clamp', 'Ultra Rapid Lispro (URLi) vs Lispro (Humalog®', 'Ultra rapid lispro (URLi', 'URLi versus Lispro']","['duration of action', 'Insulin action beyond 4\xa0h', 'duration of exposure', 'Insulin lispro and blood glucose concentrations', 'insulin lispro', 'Overall exposure and total glucose', 'maximum and total glucose', 'Onset of insulin action', 'insulin action']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",42.0,0.0551131,"Less than dose-proportional increases in maximum and total glucose infused were observed and were similar for both URLi and Lispro.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA. Electronic address: leohr_jennifer_k@lilly.com.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Klein', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Moerschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.005']
2276,32900552,"Reply to Sachin Malde, Arun Sahai, and Eskinder Solomon's Letter to the Editor re: Marcus J. Drake, Amanda L. Lewis, Grace J. Young, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.06.004.",,2020,,"['26 Hospitals', 'Men Considering Prostate Surgery']",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}]",[],[],,0.0841017,,"[{'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Athene', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",European urology,['10.1016/j.eururo.2020.08.037']
2277,32900553,"Re: Marcus J. Drake, Amanda L. Lewis, Grace J. Young, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol. In press. https://doi.org/10.1016/j.eururo.2020.06.004.",,2020,,"['26 Hospitals', 'Men Considering Prostate Surgery']",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}]",[],[],,0.152037,,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Malde', 'Affiliation': ""Department of Urology, Guy's Hospital, London, UK. Electronic address: sachin.malde@gstt.nhs.uk.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sahai', 'Affiliation': ""Department of Urology, Guy's Hospital, London, UK.""}, {'ForeName': 'Eskinder', 'Initials': 'E', 'LastName': 'Solomon', 'Affiliation': ""Department of Urology, Guy's Hospital, London, UK.""}]",European urology,['10.1016/j.eururo.2020.08.026']
2278,32900564,"Short-Term Effects of Early Postoperative Celecoxib Administration for Pain, Sleep Quality, and Range of Motion After Total Knee Arthroplasty: A Randomized Controlled Trial.","BACKGROUND


We hypothesized that early postoperative administration of celecoxib would reduce pain scores and improve sleep quality and active range of motion after total knee arthroplasty (TKA) under general anesthesia.
METHODS


Patients in the celecoxib group received 400 mg of celecoxib 2 hours after TKA, followed 6 hours later by 200 mg of celecoxib. Patients in the control group received 400 mg of celecoxib the second day after surgery. Patients in both group had access to patient-controlled analgesia fentanyl. The primary outcome measure was the patient-reported visual analog scale (VAS) pain score the second day after TKA. The secondary outcome measure was sleep quality (days 1, 2, and 7 postoperatively). Active knee joint range of motion was assessed on days 2 and 7 postoperatively, and VAS pain scores were evaluated on postoperative days 1 to 7. Total fentanyl consumption was also assessed.
RESULTS


Compared to the control group, the celecoxib group had significantly lower median VAS pain scores on postoperative days 1 and 2, significantly less nocturnal awakening (in minutes) and frequency of body motion, and better sleep efficacy on postoperative day 1. The celecoxib group also had a significantly better median flexion angle (°) on postoperative days 2 and 7, and lower cumulative fentanyl consumption.
CONCLUSION


Early administration of celecoxib after TKA was associated with significantly reduced early VAS pain scores and improved sleep quality and active knee flexion angles. Thus, the early administration of celecoxib after TKA under general anesthesia may reduce pain and improve sleep quality and functional recovery.
LEVELS OF EVIDENCE


Level II, therapeutic study.
TRIAL REGISTRATION


UMIN-CTR 000014624 (July 23, 2014).",2020,"The celecoxib group also had a significantly better median flexion angle (°) on postoperative days 2 and 7, and lower cumulative fentanyl consumption.
","['Patients in the', 'After Total Knee Arthroplasty']","['Early Postoperative Celecoxib', 'celecoxib', 'celecoxib 2\xa0hours after TKA, followed 6\xa0hours later by 200 mg of celecoxib']","['Total fentanyl consumption', 'median flexion angle', 'Pain, Sleep Quality, and Range of Motion', 'sleep quality and active knee flexion angles', 'median VAS pain scores', 'pain and improve sleep quality and functional recovery', 'nocturnal awakening (in minutes) and frequency of body motion, and better sleep efficacy', 'access to patient-controlled analgesia fentanyl', 'early VAS pain scores', 'patient-reported visual analog scale (VAS) pain score the second day after TKA', 'sleep quality and active range of motion', 'Active knee joint range of motion', 'sleep quality', 'VAS pain scores', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",,0.444624,"The celecoxib group also had a significantly better median flexion angle (°) on postoperative days 2 and 7, and lower cumulative fentanyl consumption.
","[{'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Mammoto', 'Affiliation': 'Department of Orthopaedic Surgery and Sports Medicine, Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital, University of Tsukuba, Mito, Ibaraki, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Fujie', 'Affiliation': 'Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Taguchi', 'Affiliation': 'Department of Anesthesiology, Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital, University of Tsukuba, Mito, Ibaraki, Japan.'}, {'ForeName': 'Enbo', 'Initials': 'E', 'LastName': 'Ma', 'Affiliation': 'Health Promotion Center, Fukushima Medical University, Fukushima City, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Anesthesiology, Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital, University of Tsukuba, Mito, Ibaraki, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Tsukuba Clinical Research and Development Organization (T-CReDO), University of Tsukuba, Tsukuba, Ibaraki, Japan.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.08.018']
2279,32900583,"The Efficacy of Lactobacillus-Containing Probiotic Supplementation in Hemodialysis Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVES


This study was performed to determine the effects of probiotic supplementation on cholesterol-triglyceride ratio, an indirect marker of insulin resistance, protein-bound uremic toxins, biomarkers of inflammation, and microbial translocation in end-stage renal disease patients on hemodialysis.
METHODS


Fifty-six patients aged 39-75 years were assigned into two groups to receive either probiotic sachets (n = 28) or a placebo (n = 28) in a randomized double-blinded placebo-controlled clinical trial. The patients in the probiotic group received twice daily sachets that contained a mixture of three viable and freeze-dried strains: Lactococcus lactis subsp. Lactis LL358, Lactobaccillus salivarius LS159, and Lactobaccillus pentosus LPE588 at high dose (100 billion; 1 × 10 11  cfu/day) for 6 months.
RESULTS


A total of 50 patients were available for final analysis. Probiotic supplementation did not have a significant influence on cholesterol-triglyceride ratio. Probiotic supplementation for 6 months caused a significant decrease in serum levels of indoxyl sulfate. Compared with the placebo, probiotic supplementation did not result in significant changes in hemoglobin levels, blood urea nitrogen, blood glucose, serum p-cresyl sulfate, inflammatory, and microbial translocation markers. No clinically significant changes in body composition were observed between the two groups during the study period. The probiotic supplementation was well tolerated by all subjects with minimal adverse effects during the 6-month-long study.
CONCLUSION


Our results suggest that high-dose multistrain lactobaccillus probiotic supplementation over 6 months as a monotherapy did not significantly decrease markers of insulin resistance, cholesterol-triglyceride ratio, and most of the studied markers, with the exception of levels of indoxyl sulfate in patients on HD.",2020,"Compared with the placebo, probiotic supplementation did not result in significant changes in hemoglobin levels, blood urea nitrogen, blood glucose, serum p-cresyl sulfate, inflammatory, and microbial translocation markers.","['Hemodialysis Patients', 'end-stage renal disease patients on hemodialysis', 'Fifty-six patients aged 39-75\xa0years', '50 patients were available for final analysis']","['probiotic sachets', 'probiotic supplementation', 'Lactobacillus-Containing Probiotic Supplementation', 'placebo, probiotic supplementation', 'placebo', 'Probiotic supplementation', 'Placebo', 'twice daily sachets that contained a mixture of three viable and freeze-dried strains: Lactococcus lactis subsp']","['hemoglobin levels, blood urea nitrogen, blood glucose, serum p-cresyl sulfate, inflammatory, and microbial translocation markers', 'serum levels of indoxyl sulfate', 'cholesterol-triglyceride ratio, an indirect marker of insulin resistance, protein-bound uremic toxins, biomarkers of inflammation, and microbial translocation', 'cholesterol-triglyceride ratio', 'body composition', 'insulin resistance, cholesterol-triglyceride ratio']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0038408', 'cui_str': 'Lactococcus lactis'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0040715', 'cui_str': 'Chromosomal translocation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021210', 'cui_str': 'Indican'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0033618', 'cui_str': 'Protein binding'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}]",50.0,0.310169,"Compared with the placebo, probiotic supplementation did not result in significant changes in hemoglobin levels, blood urea nitrogen, blood glucose, serum p-cresyl sulfate, inflammatory, and microbial translocation markers.","[{'ForeName': 'Paik Seong', 'Initials': 'PS', 'LastName': 'Lim', 'Affiliation': ""Division of Renal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan, Republic of China.""}, {'ForeName': 'Hsueh Fang', 'Initials': 'HF', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Institute of Biomedical Nutrition, Hungkuang University, Taichung, Taiwan, Republic of China. Electronic address: fang54@hk.edu.tw.'}, {'ForeName': 'Mei Chen', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Department of Nutrition, Institute of Biomedical Nutrition, Hungkuang University, Taichung, Taiwan, Republic of China.'}, {'ForeName': 'Li-Shu', 'Initials': 'LS', 'LastName': 'Chiu', 'Affiliation': ""Division of Renal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan, Republic of China.""}, {'ForeName': 'Ming-Ying', 'Initials': 'MY', 'LastName': 'Wu', 'Affiliation': ""Division of Renal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan, Republic of China.""}, {'ForeName': 'Wui-Chen', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': ""Division of Renal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan, Republic of China.""}, {'ForeName': 'Tsai Kun', 'Initials': 'TK', 'LastName': 'Wu', 'Affiliation': ""Division of Renal Medicine, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan, Republic of China.""}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.07.002']
2280,32900598,[Acquiring and maintaining knowledge about cancer from a healthcare audit system in adolescents].,"INTRODUCTION


Cancer is one of the leading causes of death in all ages. Promoting knowledge about the disease and its risk factors in adolescents can contribute to adopting healthy lifestyles in adulthood.
OBJECTIVE


To evaluate the acquisition of knowledge about cancer and its retention over time in a group of adolescents, after the implementation of a healthcare audit system.
MATERIALS AND METHODS


A before and after, quasi-experimental study was carried out, in adolescents from an urban secondary school in Ciego de Ávila (Cuba), between September 2017 and July 2018. The study consisted of 145 students between 12 and 15 years of age. The study was carried out in three stages: diagnosis, design and intervention, and evaluation (immediate and at six months). At six months, participants were compared with 73 other adolescents (control group) that had not received the audit system.
RESULTS


More than two-thirds (69%) of adolescents reported not having received information about cancer or its risk factors, and a large majority (77.2%) considering the need to receive it. By applying the designed audit system, the mean score of the participating group increased (5.08±0.27 vs. 7.0±1.51; P<.01). At six months of evaluation, significant maintenance of the knowledge acquired was achieved (7.0±1.51 vs. 5.98±1.73; P<.01), despite the mean being lower than the first stage.
CONCLUSIONS


The health audit system managed to satisfy learning needs and light maintenance of knowledge in students six months after its application, and is considered a tool for health promotion and its application is recommended in other settings and areas where conditions allow it.",2020,"By applying the designed audit system, the mean score of the participating group increased (5.08±0.27 vs. 7.0±1.51; P<.01).","['adolescents', '145 students between 12 and 15 years of age', 'A before and after, quasi-experimental study was carried out, in adolescents from an urban secondary school in Ciego de Ávila (Cuba), between September 2017 and July 2018']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]",[],[],145.0,0.0203654,"By applying the designed audit system, the mean score of the participating group increased (5.08±0.27 vs. 7.0±1.51; P<.01).","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hernández-García', 'Affiliation': 'Facultad de Ciencias Médicas «Dr. José Assef Yara», Universidad de Ciencias Médicas de Ciego de Ávila, Ciego de Ávila, Cuba. Electronic address: frankhernandezgarcia1996@gmail.com.'}, {'ForeName': 'José Ignacio', 'Initials': 'JI', 'LastName': 'Robaina-Castillo', 'Affiliation': 'Facultad de Ciencias Médicas «Dr. José Assef Yara», Universidad de Ciencias Médicas de Ciego de Ávila, Ciego de Ávila, Cuba.'}, {'ForeName': 'Norma Ciriaca', 'Initials': 'NC', 'LastName': 'Pérez Calleja', 'Affiliation': 'Universidad de Ciencias Médicas de Ciego de Ávila, Ciego de Ávila, Cuba.'}, {'ForeName': 'Elena Del Carmen', 'Initials': 'EDC', 'LastName': 'González Díaz', 'Affiliation': 'Facultad de Ciencias Médicas «Dr. José Assef Yara», Universidad de Ciencias Médicas de Ciego de Ávila, Ciego de Ávila, Cuba.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Sinal Montalvo', 'Affiliation': 'Policlínica del Ministerio del Interior, Ciego de Ávila, Cuba.'}, {'ForeName': 'Luis Alberto', 'Initials': 'LA', 'LastName': 'Lazo Herrera', 'Affiliation': 'Facultad de Ciencias Médicas «Dr. Ernesto Che Guevara de la Serna», Universidad de Ciencias Médicas de Pinar del Río, Pinar del Río, Cuba.'}]",Semergen,['10.1016/j.semerg.2020.07.002']
2281,32900605,Assessing the effectiveness of a narrative-based patient education video for promoting opioid tapering.,"OBJECTIVE


To compare effectiveness of a narrative-based educational video versus an informational pamphlet for increasing patients' self-efficacy and intention to taper their opioid use.
METHODS


Five thousand participants recruited from MTurk were screened to identify eligible patients. Eligible participants (n = 365, 49.9 % female, mean age = 37 years) were randomized to either watch the narrative video or read the pamphlet. Linear regression models were used for the main analysis.
RESULTS


Participants' perceptions of tapering effectiveness were higher in the video group (mean = 4.06) than the pamphlet group (mean = 3.67), adjusted mean difference = 0.34, 95 %CI 0.13 - 0.54,P < 0.001. Participants' perceptions of tapering self-efficacy were also higher in the video group (mean = 3.97) than the pamphlet group (mean = 3.60), adjusted mean difference = 0.32, 95 %CI 0.09 - 0.55, P < 0.001. Perceived tapering effectiveness and self-efficacy were both positively associated with post-intervention tapering intention (Spearman rank correlation coefficient = 0.38 and 0.53, respectively, both P < 0.001).
CONCLUSION


A narrative-based video about opioid tapering enhanced patients' perceptions of the effectiveness of tapering and their tapering self-efficacy.
PRACTICE IMPLICATIONS


Narrative-based videos may be effective for changing patient attitudes about opioid tapering.",2020,"Perceived tapering effectiveness and self-efficacy were both positively associated with post-intervention tapering intention (Spearman rank correlation coefficient = 0.38 and 0.53, respectively, both P < 0.001).
","['Eligible participants (n = 365, 49.9 % female, mean age = 37 years', 'Five thousand participants recruited from MTurk were screened to identify eligible patients']","['narrative video or read the pamphlet', 'narrative-based patient education video', 'narrative-based educational video versus an informational pamphlet']","['perceptions of tapering self-efficacy', 'perceptions of tapering effectiveness', 'Perceived tapering effectiveness and self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",5000.0,0.0575067,"Perceived tapering effectiveness and self-efficacy were both positively associated with post-intervention tapering intention (Spearman rank correlation coefficient = 0.38 and 0.53, respectively, both P < 0.001).
","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Feng', 'Affiliation': 'Department of Communication, University of California Davis, Davis, USA. Electronic address: bfeng@ucdavis.edu.'}, {'ForeName': 'Yining Z', 'Initials': 'YZ', 'LastName': 'Malloch', 'Affiliation': 'Department of Communication, University of California Davis, Davis, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Kravitz', 'Affiliation': 'Department of Internal Medicine, University of California Davis, Sacramento, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Verba', 'Affiliation': 'Department of Design, University of California Davis, Davis, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Iosif', 'Affiliation': 'Department of Public Health Sciences, University of California Davis, Sacramento, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Slavik', 'Affiliation': 'Department of Design, University of California Davis, Davis, USA.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Henry', 'Affiliation': 'Department of Internal Medicine, University of California Davis, Sacramento, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.019']
2282,32900653,Improvements in biometric health measures among individuals with intellectual disabilities: A controlled evaluation of the Fit 5 program.,"BACKGROUND


Individuals with intellectual disabilities (ID) have poorer health statuses compared to the general population. Actions are needed to address health disparities and promote healthy lifestyles among individuals with ID. Moreover, studies that consider program settings for this population are needed.
OBJECTIVE


The Special Olympics health program, Fit 5, was evaluated to assess effectiveness in improving health measures for individuals with ID. The settings of programs' implementation were also considered.
METHODS


Four Special Olympics basketball teams participated as an intervention group, and three teams as a control group, in a study of the Fit 5 program that was implemented during, and as part of, a regular 8-week basketball season. Resting heart rate (RHR) and blood pressure, and height and weight to calculate Body Mass Index (BMI), were measured before and after the program. Differences in pre- and post-measures were compared between the two groups with paired samples t-tests and ANCOVA.
RESULTS


Participants in the intervention group had significantly greater improvements in resting systolic and diastolic blood pressures (p = 0.02 and 0.03, respectively) and RHR (p = 0.003). BMI increased for both groups; however, the increase in the intervention group was significantly less (p = 0.006). The Special Olympics setting was considered familiar and supportive and effectively reached individuals with ID.
CONCLUSION


The Fit 5 program positively impacts RHR and blood pressure, and could help reduce extents of BMI increases, in individuals with ID when implemented in a common setting. Further investigation of the impact of Fit 5 and similar programs in additional settings is warranted.",2020,"RESULTS


Participants in the intervention group had significantly greater improvements in resting systolic and diastolic blood pressures (p = 0.02 and 0.03, respectively) and RHR (p = 0.003).","['individuals with intellectual disabilities', 'individuals with ID', 'Individuals with intellectual disabilities (ID']",[],"['health measures', 'BMI', 'Resting heart rate (RHR) and blood pressure, and height and weight to calculate Body Mass Index (BMI', 'RHR', 'RHR and blood pressure', 'biometric health measures', 'resting systolic and diastolic blood pressures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0424638', 'cui_str': 'Height and weight'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0283323,"RESULTS


Participants in the intervention group had significantly greater improvements in resting systolic and diastolic blood pressures (p = 0.02 and 0.03, respectively) and RHR (p = 0.003).","[{'ForeName': 'Brandi S', 'Initials': 'BS', 'LastName': 'Niemeier', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Whitewater, 800 West Main Street, Whitewater, WI, 53190, USA. Electronic address: niemeieb@uww.edu.'}, {'ForeName': 'Lisa-Christin', 'Initials': 'LC', 'LastName': 'Wetzlmair', 'Affiliation': 'Department of Kinesiology, University of Wisconsin-Whitewater, 800 West Main Street, Whitewater, WI, 53190, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bock', 'Affiliation': 'Special Olympics Wisconsin, 2310 Crossroads Dr, Suite 1000, Madison, WI, 53718, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Schoenbrodt', 'Affiliation': 'Special Olympics Wisconsin, 2310 Crossroads Dr, Suite 1000, Madison, WI, 53718, USA.'}, {'ForeName': 'Kathleen J', 'Initials': 'KJ', 'LastName': 'Roach', 'Affiliation': 'Special Olympics Wisconsin, 2310 Crossroads Dr, Suite 1000, Madison, WI, 53718, USA.'}]",Disability and health journal,['10.1016/j.dhjo.2020.100979']
2283,32894418,Internet-Delivered Cognitive Behavioral Therapy and Psychoeducation Program for Patients with Gastrointestinal Stromal Tumors.,"Gastrointestinal stromal tumors (GIST) account for 0.2-3% of all cancer diagnoses and are thus considered a rare type of cancer. Severe levels of fatigue occur in 33% of patients on imatinib, but besides treatment, fatigue is also associated with psychological distress. As far as we know, only one previous study has reported on the design of a psychoeducational intervention for caregivers and patients with GIST. The current study was conducted to compare the preliminary effectiveness of an Internet-delivered cognitive behavioral stress management intervention and psychoeducation program for anxiety, depression, fatigue, and quality of life in patients with gastrointestinal stromal tumors (GIST). This study had an experimental pre-test post-test design with a control group. Ninety-nine patients were randomly allocated to an Internet-delivered cognitive program (n = 50) or psychoeducation control group (n = 49). Participants completed the questionnaires at three time points (pre-test, post-test, and 3-month follow-up). Twenty-seven participants completed the intervention. A significant interaction effect between groups and time was found for general fatigue [F(2, 28) = 8.2, p < 0.001, ƞ 2 p  = 0.25], reduced motivation [F(2, 28) = 3.5, p < 0.05, ƞ 2 p  = 0.12], distress [F(2, 28) = 3.4, p < 0.05, ƞ 2 p  = 0.12], and global health status [F(2, 28) = 3.8, p < 0.05, ƞ 2 p  = 0.13]. Both intervention programs showed reductions in the dimensions of fatigue and improvements in distress and dimensions of quality of life. Additional research on a larger sample size is needed to confirm the effects obtained in this study.",2020,Both intervention programs showed reductions in the dimensions of fatigue and improvements in distress and dimensions of quality of life.,"['caregivers and patients with GIST', 'Ninety-nine patients', 'Patients with Gastrointestinal Stromal Tumors', 'patients with gastrointestinal stromal tumors (GIST']","['Internet-Delivered Cognitive Behavioral Therapy and Psychoeducation Program', 'Internet-delivered cognitive program (n\u2009=\u200950) or psychoeducation control group', 'psychoeducational intervention', 'Internet-delivered cognitive behavioral stress management intervention and psychoeducation program']","['anxiety, depression, fatigue, and quality of life', 'Severe levels of fatigue occur', 'Gastrointestinal stromal tumors (GIST) account', 'dimensions of fatigue and improvements in distress and dimensions of quality of life', 'global health status']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C3828813', 'cui_str': '99'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",99.0,0.0256986,Both intervention programs showed reductions in the dimensions of fatigue and improvements in distress and dimensions of quality of life.,"[{'ForeName': 'Edelmira Berenice', 'Initials': 'EB', 'LastName': 'Carbajal-López', 'Affiliation': 'Psychology School, Fundación GIST Mexico, Universidad Autónoma de Nuevo León, Monterrey, Mexico.'}, {'ForeName': 'Dehisy Marisol', 'Initials': 'DM', 'LastName': 'Juárez-García', 'Affiliation': 'Psychology School, Universidad Autónoma de Nuevo León, Monterrey, Mexico. dehisy_jg@yahoo.com.mx.'}, {'ForeName': 'Absalón', 'Initials': 'A', 'LastName': 'Espinoza-Velazco', 'Affiliation': 'UMAE High Specialty Hospital 25, Instituto Mexicano del Seguro Social, Monterrey, Mexico.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Calderillo-Ruiz', 'Affiliation': 'Instituto Nacional de Cancerología, Ciudad de México, Mexico.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-020-01866-3']
2284,32894453,12 Months later: Motivational interviewing plus nutrition psychoeducation for weight loss in primary care.,"PURPOSE


Motivational interviewing (MI) weight-loss interventions have garnered much attention, particularly in primary care. Few studies, however, have examined long-term outcomes of MI for weight loss in primary care. This study sought to examine the longer-term outcomes of a combination approach comprising MI and nutrition psychoeducation (MINP) with a publically available web-support component (i.e., livestrong.com).
METHODS


Thirty-one adults with overweight/obesity were enrolled in a 3-month MINP treatment delivered in primary care by medical assistants. Weight, blood pressure, and depression (beck depression inventory) were assessed at baseline and 1-year following treatment cessation (i.e., 15 months total).
RESULTS


Participants' average BMI was significantly lower 12-months following treatment. Approximately one-third of participants (34.8%) maintained 5% or more weight loss. Participants also experienced significant decreases in diastolic blood pressure, resting heart rate, and depression symptoms, but not systolic blood pressure or waist circumference.
CONCLUSION


The scalable (2.5 h total) MINP intervention delivered in primary care by medical assistants resulted in significant weight (medium effect size) and psychological improvements 12 months later. These findings complement previous RCT findings that MI or nutrition psychoeducation interventions, delivered separately, resulted in small weight loss effects after 12 months, with 5% and 17% of participants, respectively, maintaining 5% weight loss. It remains unclear, however, if implementing MI in primary care for weight loss is cost effective beyond providing nutrition psychoeducation alone.
CLINICAL TRIAL REGISTRATION


The clinical trial registration number is NCT02578199.
LEVEL OF EVIDENCE


IV, uncontrolled trial.",2020,"Participants also experienced significant decreases in diastolic blood pressure, resting heart rate, and depression symptoms, but not systolic blood pressure or waist circumference.
",['Thirty-one adults with overweight/obesity were enrolled in a 3-month'],"['MINP treatment delivered in primary care by medical assistants', 'combination approach comprising MI and nutrition psychoeducation (MINP) with a publically available web-support component (i.e., livestrong.com', 'Motivational interviewing (MI) weight-loss interventions', 'Motivational interviewing plus nutrition psychoeducation']","['weight loss', 'diastolic blood pressure, resting heart rate, and depression symptoms', 'systolic blood pressure or waist circumference', 'small weight loss effects', 'average BMI', 'Weight, blood pressure, and depression (beck depression inventory']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0334914', 'cui_str': 'Medical assistant'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",31.0,0.0384018,"Participants also experienced significant decreases in diastolic blood pressure, resting heart rate, and depression symptoms, but not systolic blood pressure or waist circumference.
","[{'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Barnes', 'Affiliation': 'Division of General Internal Medicine, University of Minnesota Medical School, MMC 741 420 Delaware Street SE, Minneapolis, MN, 55455, USA. rdbarnes@umn.edu.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Ivezaj', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00994-5']
2285,32894558,"The effect of myo-inositol, vitamin D3 and melatonin on the oocyte quality and pregnancy in in vitro fertilization: a randomized prospective controlled trial.","OBJECTIVE


To evaluate the efficacy of a treatment with Myo-inositol (MI) plus melatonin and vitamin D3 in women underwent intra cytoplasmatic sperm injection (ICSI).
PATIENTS AND METHODS


100 women undergoing ICSI procedure were enrolled and randomly divided 1:1 in two groups. The study group was treated with 2 g MI, 50 mg Alpha-Lactalbumin (alpha-LA) and 200 µg folic acid in powder every morning for 6 months (3 months before oocyte pick up and 3 months after ICSI); the same patients underwent treatment with 600 mg MI, 1 mg melatonin plus 200 µg folic acid during the evening for 3 months before oocyte pick up; subsequently the pick up these patients were treated with 600 mg MI, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 as cholecalciferol until the 12th week of gestation. The control group was treated with 200 µg folic acid twice a day. Clinical pregnancy rate was evaluated as primary outcome, followed by blastocyst and oocyte quality, as well as gestational period as secondary outcomes.
RESULTS


Treatment significantly improved blastocyst and oocyte quality in the study group, achieving the 42% of clinical pregnancies vs. 24% in the control group, even though the course of pregnancy did not significantly differ between the groups. However, the mean gestational period was shorter in the control group.
CONCLUSIONS


The supplementation of MI in combination with melatonin in the first 3 months before oocyte pick up and with vitamin D3 in the further 3 months could represent an innovative support for all those women undergoing ICSI.",2020,"However, the mean gestational period was shorter in the control group.
","['women underwent intra cytoplasmatic sperm injection (ICSI', '100 women undergoing ICSI procedure', 'vitro fertilization']","['melatonin', '200 µg folic acid', 'myo-inositol, vitamin D3 and melatonin', 'Myo-inositol (MI) plus melatonin and vitamin D3', '2 g MI, 50 mg Alpha-Lactalbumin (alpha-LA) and 200 µg folic acid', '600 mg MI, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 as cholecalciferol', 'melatonin plus 200 µg folic acid']","['course of pregnancy', 'oocyte quality and pregnancy', 'mean gestational period', 'blastocyst and oocyte quality, as well as gestational period as secondary outcomes', 'blastocyst and oocyte quality', 'Clinical pregnancy rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002287', 'cui_str': 'Alpha-lactalbumin'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",100.0,0.0715,"However, the mean gestational period was shorter in the control group.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wdowiak', 'Affiliation': 'Diagnostic Techniques Unit, Medical University of Lublin, Lublin, Poland. wdowiakartur@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Filip', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202008_22649']
2286,32894625,Helicobacter pylori Eradication in Parkinson's Disease: A Randomized Placebo-Controlled Trial.,"BACKGROUND


Helicobacter pylori (HP) infection has been associated with worse motor function in Parkinson's disease (PD).
OBJECTIVE


We aimed to evaluate the effects of HP eradication on PD symptoms.
METHODS


In this parallel-group, double-blind, randomized placebo-controlled, single-center trial, patients with PD with positive HP urea breath test and serology were block randomized (1:1) to receive standard eradication triple therapy or identically appearing placebo capsules for 1 week. Prespecified motor (International Parkinson and Movement Disorder Society Unified PD Rating Scale [MDS-UPDRS], timed tests, and home-based wearable sensor measurements), nonmotor (Leeds Dyspepsia Questionnaire and Montreal Cognitive Assessment), and quality-of-life (Parkinson's Disease Questionnaire-39) outcome measures were assessed at weeks 6, 12, 24, and 52. The primary outcome was the baseline-to-week 12 change in ON medication MDS-UPDRS motor scores. Lactulose-hydrogen breath testing for concomitant small intestinal bacterial overgrowth was performed at baseline and repeated at week 24, together with the urea breath test.
RESULTS


A total of 310 patients were screened for eligibility and 80 were randomly assigned, of whom 67 were included in the full-analysis set (32 treatment group patients, 35 placebo patients). HP eradication did not improve MDS-UPDRS motor scores at week 12 (mean difference 2.6 points in favor of placebo, 95% confidence interval: -0.4 to 5.6, P = 0.089). There was no significant improvement in any motor, nonmotor, or quality-of-life outcome at weeks 12 and 52. Both the full-analysis and per-protocol analyses (based on eradication status) supported these conclusions. Small intestinal bacterial overgrowth status did not influence treatment results.
CONCLUSIONS


HP eradication does not improve clinical outcomes in PD, suggesting that there is no justification for routine HP screening or eradication with the goal of improving PD symptoms. © 2020 International Parkinson and Movement Disorder Society.",2020,"There was no significant improvement in any motor, nonmotor, or quality-of-life outcome at weeks 12 and 52.","['310 patients were screened for eligibility and 80 were randomly assigned, of whom 67 were included in the full-analysis set (32 treatment group patients, 35 placebo patients', ""Parkinson's disease (PD"", ""Parkinson's Disease"", 'patients with PD with positive HP urea breath test and serology']","['standard eradication triple therapy or identically appearing placebo capsules', 'placebo', 'Lactulose-hydrogen breath testing', 'HP eradication', 'Placebo']","['MDS-UPDRS motor scores', 'baseline-to-week 12 change in ON medication MDS-UPDRS motor scores', 'motor, nonmotor, or quality-of-life outcome', 'HP eradication', ""Prespecified motor (International Parkinson and Movement Disorder Society Unified PD Rating Scale [MDS-UPDRS], timed tests, and home-based wearable sensor measurements), nonmotor (Leeds Dyspepsia Questionnaire and Montreal Cognitive Assessment), and quality-of-life (Parkinson's Disease Questionnaire-39) outcome measures"", 'Helicobacter pylori Eradication']","[{'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1611185', 'cui_str': 'Helicobacter pylori urea breath test'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0020275', 'cui_str': 'Hydrogen'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",310.0,0.723345,"There was no significant improvement in any motor, nonmotor, or quality-of-life outcome at weeks 12 and 52.","[{'ForeName': 'Ai Huey', 'Initials': 'AH', 'LastName': 'Tan', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Shen-Yang', 'Initials': 'SY', 'LastName': 'Lim', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Sanjiv', 'Initials': 'S', 'LastName': 'Mahadeva', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mun Fai', 'Initials': 'MF', 'LastName': 'Loke', 'Affiliation': 'Department of Medical Microbiology, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Jiun Yan', 'Initials': 'JY', 'LastName': 'Tan', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Ban Hong', 'Initials': 'BH', 'LastName': 'Ang', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Kok Ping', 'Initials': 'KP', 'LastName': 'Chin', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Amni Fatihah', 'Initials': 'AF', 'LastName': 'Mohammad Adnan', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Shawna Mei Chien', 'Initials': 'SMC', 'LastName': 'Ong', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Aimi Izzah', 'Initials': 'AI', 'LastName': 'Ibrahim', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Nusyaibah', 'Initials': 'N', 'LastName': 'Zulkifli', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Jing Kun', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Wan Ting', 'Initials': 'WT', 'LastName': 'Lim', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Yong Teck', 'Initials': 'YT', 'LastName': 'Teo', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Yong Leng', 'Initials': 'YL', 'LastName': 'Kok', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Tze Ying', 'Initials': 'TY', 'LastName': 'Ng', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Aaron Guan Siang', 'Initials': 'AGS', 'LastName': 'Tan', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Intan Maisara', 'Initials': 'IM', 'LastName': 'Zulkifle', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Chin Khoon', 'Initials': 'CK', 'LastName': 'Ng', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Soon Sean', 'Initials': 'SS', 'LastName': 'Ee', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Shuhaina', 'Initials': 'S', 'LastName': 'Arafin', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Khairunnisa', 'Initials': 'K', 'LastName': 'Mohamad Shukori', 'Affiliation': ""Division of Neurology, Department of Medicine, and the Mah Pooi Soo and Tan Chin Nam Centre for Parkinson's and Related Disorders, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.""}, {'ForeName': 'Jamunarani S', 'Initials': 'JS', 'LastName': 'Vadivelu', 'Affiliation': 'Department of Medical Microbiology, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Marras', 'Affiliation': ""Division of Neurology, Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Fox', 'Affiliation': ""Division of Neurology, Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Lang', 'Affiliation': ""Division of Neurology, Edmond J. Safra Program in Parkinson's Disease and the Morton and Gloria Shulman Movement Disorders Clinic, Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada.""}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.28248']
2287,31810613,Evaluation of the clinical behavior of 2 different materials for implant-supported interim fixed partial prostheses: A randomized clinical trial.,"STATEMENT OF PROBLEM


Clinical studies about interim implant-supported prostheses made of polymethylmethacrylate (PMMA) and polyoxymethylene (POM) have been limited to clinical reports or studies on the survival of implants subjected to immediate loading without evaluating the influence of the material used.
PURPOSE


The purpose of this randomized clinical trial was to evaluate the clinical performance of posterior resin interim implant-supported fixed partial dentures (FPDs) made of 2 different computer-aided design and computer-aided manufactured (CAD-CAM) materials: PMMA and POM.
MATERIAL AND METHODS


A total of 21 participants received 49 interim implant-supported FPDs. The same participant received the PMMA as part of the control group and the POM as part of the experimental group. The restorations were evaluated at 1 week and 3 and 6 months after their placement, using the California Dental Association (CDA) quality-evaluation index. Their functional wear and color stability were also evaluated. Data were analyzed by using nonparametric statistics (α=.05).
RESULTS


The CDA criteria showed that the PMMA group performed better than the POM group in the surface and color parameter (P<.05). Fractures at the implant connection level were observed in 10 prostheses. The number of fractures was significantly higher in internal conical connection implants (P<.05). The statistical analysis of color stability showed values of ΔE*ab of 7.18 for PMMA and 8.58 for POM, without significant differences between materials. Concerning the wear evaluation, a significant increase in the wear of both materials was found at 6 months of functioning (P<.05). No significant differences were found within materials.
CONCLUSIONS


Within a 6-month observation period, PMMA interim implant-supported FPDs performed better than POM in the surface and color parameter. Entirely polymer posterior implant-supported FPDs with internal conical connection implants appear to be more susceptible to fracture.",2020,The number of fractures was significantly higher in internal conical connection implants (P<.05).,[],"['PMMA', '49 interim implant-supported FPDs', 'POM', 'posterior resin interim implant-supported fixed partial dentures (FPDs', 'polymethylmethacrylate (PMMA) and polyoxymethylene (POM']","['California Dental Association (CDA) quality-evaluation index', 'functional wear and color stability', 'number of fractures']",[],"[{'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0011461', 'cui_str': 'Fixed Partial Denture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}]","[{'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015193', 'cui_str': 'Evaluation Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",21.0,0.0346008,The number of fractures was significantly higher in internal conical connection implants (P<.05).,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Díez-Quijano', 'Affiliation': 'Researcher, Department of Conservative Dentistry and Orofacial Prosthodontics, School of Dentistry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Azevedo', 'Affiliation': 'Postgraduate student, Department of Conservative Dentistry and Orofacial Prosthodontics, School of Dentistry, Complutense University of Madrid, Madrid, Spain. Electronic address: luisazevedo.2005@gmail.com.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Antonaya-Martín', 'Affiliation': 'Clinical Assistant Professor, Department of Conservative Dentistry and Orofacial Prosthodontics, School of Dentistry. Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Del Río-Highsmith', 'Affiliation': 'Full-time Professor, Department of Conservative Dentistry and Orofacial Prosthodontics, School of Dentistry, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Gómez-Polo', 'Affiliation': 'Reader Professor, Department of Conservative Dentistry and Orofacial Prosthodontics, School of Dentistry, Complutense University of Madrid, Madrid, Spain.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2019.09.021']
2288,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE


This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS


Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction times (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance) following PSD were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2  (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION


The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS


Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Achraf', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany; Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
2289,32891639,Impact of Perioperative Multidisciplinary Rehabilitation Pathway on Early Outcomes after Robot-Assisted Radical Cystectomy: A Matched Analysis.,"OBJECTIVE


To investigate the effect of incorporating physical rehabilitation, nutrition and psychosocial care as part of the ""NEEW"" (Nutrition, Exercise, patient Education and Wellness) on perioperative outcomes after Robot-Assisted Radical Cystectomy (RARC).
METHODS


Patients were divided into 2 groups:  pathway group (NEEW in addition to ERAS), versus pre-pathway group, before NEEW initiation (ERAS only). Propensity score matching was performed (ratio 1:2 ratio). Perioperative outcomes were analyzed and compared. Multivariate analyses were modeled to assess for association between NEEW pathway and postoperative outcomes.
RESULT


192 were included in the study: 64 patients (33%) in the pathway group vs. 128 patients (67%) in the pre-pathway group. Pathway group had shorter median inpatient stay (5 vs 6 days, p<0.01), faster bowel recovery (3 vs 4 days, p < 0.01), and better pain scores, and demonstrated fewer 30-day high grade complications (5% vs 16%, p=0.02). On multivariate analysis, the NEEW pathway was associated with shorter hospital stay (1.75 days shorter), faster bowel recovery (1 day faster), longer functional mobility time (4 mins longer) and less pain scores (average 1 point less).
CONCLUSION


Standardized perioperative pathway with weekly multidisciplinary team meeting was associated with improved short-term perioperative outcomes after RARC.",2020,"Pathway group had shorter median inpatient stay (5 vs 6 days, p<0.01), faster bowel recovery (3 vs 4 days, p < 0.01), and better pain scores, and demonstrated fewer 30-day high grade complications (5% vs 16%, p=0.02).","['192 were included in the study: 64 patients (33%) in the pathway group vs. 128 patients (67%) in the pre-pathway group', 'Patients were divided into 2 groups']","['Robot-Assisted Radical Cystectomy (RARC', 'physical rehabilitation, nutrition and psychosocial care', 'Robot-Assisted Radical Cystectomy', 'pathway group (NEEW in addition to ERAS), versus pre-pathway group, before NEEW initiation (ERAS only']","['shorter median inpatient stay', 'shorter hospital stay', 'longer functional mobility time', 'faster bowel recovery', '30-day high grade complications', 'pain scores', 'Perioperative outcomes']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C1455743', 'cui_str': 'Psychosocial assessment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0420512', 'cui_str': 'Inpatient stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",192.0,0.0593086,"Pathway group had shorter median inpatient stay (5 vs 6 days, p<0.01), faster bowel recovery (3 vs 4 days, p < 0.01), and better pain scores, and demonstrated fewer 30-day high grade complications (5% vs 16%, p=0.02).","[{'ForeName': 'Naif A', 'Initials': 'NA', 'LastName': 'Aldhaam', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Ahmed S', 'Initials': 'AS', 'LastName': 'Elsayed', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Hussein', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Alat', 'Initials': 'A', 'LastName': 'Siam', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Osei', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Babar', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Graton', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Kurtz', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychosocial Oncology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Rowan', 'Affiliation': 'Department of Ambulatory Services, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Department of Physical Therapy, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA.'}, {'ForeName': 'Khurshid A', 'Initials': 'KA', 'LastName': 'Guru', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, NY, USA. Electronic address: Khurshid.guru@roswellpark.org.'}]",Urology,['10.1016/j.urology.2020.05.113']
2290,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
2291,32891709,Influence of n-acetylcysteine maintenance on the pharmacodynamic effects of oral ethanol.,"RATIONALE


Glutamate systems play an important role in the abuse related effects of alcohol. n-Acetylcysteine, a drug that promotes glutamate homeostasis, attenuates a range of alcohol effects in preclinical models.
OBJECTIVES


This human laboratory study determined the influence of n-acetylcysteine maintenance on alcohol self-administration using a model predictive of treatment effectiveness, along with the subjective, performance and physiological effects of alcohol. We hypothesized that n-acetylcysteine would attenuate alcohol self-administration, as well as positive subjective effects of alcohol.
METHODS


Nine subjects with alcohol use disorder completed this within-subjects study. Subjects were maintained on placebo, 1.2 and 2.4 g n-acetylcysteine in random order on an outpatient basis. After five days of maintenance on the target dose, subjects completed overnight inpatient experimental sessions in which the pharmacodynamic effects of alcohol were determined.
RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink). n-Acetylcysteine did not alter the effects of alcohol.
CONCLUSIONS


These results indicate that although n-acetylcysteine can safely be combined with alcohol, it does not attenuate the abuse related effects of alcohol and is unlikely to be an effective standalone alcohol use disorder treatment. However, considering study limitations, future work is needed to further understand whether and how n-acetylcysteine might be used as a treatment for alcohol use disorder (e.g., in combination with a behavioral treatment or another pharmacological agent).",2020,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).",['Nine subjects with alcohol use disorder completed this within-subjects study'],"['placebo', 'oral ethanol']","['breath alcohol concentration, increased ratings of Feel Drink']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]","[{'cui': 'C0202306', 'cui_str': 'Ethanol measurement, breath'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]",9.0,0.012153,"RESULTS


Alcohol produced prototypic effects (e.g., increased breath alcohol concentration, increased ratings of Feel Drink).","[{'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA; Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Ave, Lexington, KY 40508, USA. Electronic address: william.stoops@uky.edu.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224, USA.'}, {'ForeName': 'Lon R', 'Initials': 'LR', 'LastName': 'Hays', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Abner O', 'Initials': 'AO', 'LastName': 'Rayapati', 'Affiliation': 'Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Lile', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Behavioral Science, University of Kentucky College of Medicine, 1100 Veterans Drive, Medical Behavioral Science Building, Lexington, KY 40536-0086, USA; Department of Psychiatry, University of Kentucky College of Medicine, 245 Fountain Court, Lexington, KY 40509-1810, USA; Department of Psychology, University of Kentucky College of Arts and Sciences, 171 Funkhouser Drive, Lexington, KY 40506-0044, USA.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.173037']
2292,32891977,Social network heavy drinking moderates the effects of a brief motivational intervention for alcohol use among injured patients.,"BACKGROUND


Limited research has focused on identifying the extent to which social networks impact the effectiveness of brief alcohol interventions delivered in trauma care settings.
OBJECTIVES


The research presented here examines the extent to which the percent of heavy drinkers and percent of abstainers in one's social network moderates the effectiveness of a brief motivational intervention with and without a telephone booster on alcohol use among trauma patients.
METHOD


Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers. Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193). For the purpose of the present study, measures of alcohol-specific social network characteristics at baseline and alcohol use at 3- and 6-month follow-up were used.
RESULTS


At low percentages (0% to ~7%) of people in one's social network who are heavy drinkers, there was a negative, statistically significant effect of the BMI conditions versus the BA condition on alcohol use. However, percent of abstainers did not moderate the effects of the BMI conditions.
CONCLUSION


The results suggest that the BMI and BMI + B conditions may be most effective among patients with no heavy drinkers in their social networks. BMIs may benefit from including a component that addresses having one or more heavy drinkers in one's social network.",2020,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","['injured patients', 'trauma patients', 'Secondary data analyses were conducted using data from 596 participants (456males) who were recruited from three urban Level I trauma centers', 'patients with no heavy drinkers in their social networks']","['motivational intervention', 'motivational intervention with and without a telephone booster', 'brief advice (BA; n\xa0=\xa0200), brief motivational intervention (BMI; n\xa0=\xa0203), and BMI with a telephone booster (BMI\xa0+\xa0B; n\xa0=\xa0193']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C4319558', 'cui_str': '200'}]",[],596.0,0.015999,"Patients were randomized to one of the three intervention conditions: brief advice (BA; n = 200), brief motivational intervention (BMI; n = 203), and BMI with a telephone booster (BMI + B; n = 193).","[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Alvarez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA. Electronic address: mjalvarez2@miners.utep.edu.'}, {'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oviedo Ramirez', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research Center, University of Texas at El Paso, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106594']
2293,32892129,Efficacy of Automatic Retention Pressure of a Double-Lumen Tube Cuff: An Artificial Intubation Model.,"BACKGROUND


The movement of a double-lumen endotracheal tube (DLT) out of its appropriate position during thoracic surgery can result in the loss of one-lung ventilation (OLV), especially during pulmonary resection and node dissection. Our study aimed to validate the efficacy of automatic retention pressure control of the DLT bronchial cuff in maintaining OLV in an artificial intubation model.
MATERIALS AND METHODS


A 35-Fr left-sided DLT was intubated to the left main bronchus in an intubation simulator and connected to an anesthesia machine. The inspiratory volume, respiratory rate, and inspiratory-expiratory ratio were set at 500 mL, 12 times/min, and 1:2, respectively. A 1-kg right main bronchial traction in the lateral right was provided after OLV was established. SmartCuff (Smiths Medical, Minneapolis, Minnesota, USA) was used to maintain cuff pressure. The efficacy of retention pressure with SmartCuff (Group S) and without SmartCuff (Group WS) was compared. The primary outcome was the rate of tidal volume (TV) reduction following bronchial traction in the two groups.
RESULTS


The TVs were 289.8 ± 28.9 mL and 242.8 ± 31.9 mL in Group S and Group WS, respectively (P = 0.003). The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
CONCLUSIONS


Automatic retention pressure control of the DLT bronchial cuff improves the rate of TV reduction during right main bronchial traction in an artificial intubation model. Continuous retention cuff pressure may be useful in maintaining OLV during thoracic surgery.",2020,"The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
",[],"['SmartCuff (Group S) and without SmartCuff (Group WS', 'Automatic Retention Pressure of a Double-Lumen Tube Cuff', 'automatic retention pressure control of the DLT bronchial cuff', 'SmartCuff ']","['rate of TV reduction', 'rate of TV reduction after bronchial traction', 'inspiratory volume, respiratory rate, and inspiratory-expiratory ratio', 'rate of tidal volume (TV) reduction following bronchial traction']",[],"[{'cui': 'C0441853', 'cui_str': 'Group S'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441110', 'cui_str': 'Tube cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2584423', 'cui_str': 'Double lumen tracheobronchial tube'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}]","[{'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",,0.0364977,"The rate of TV reduction after bronchial traction was significantly lower in Group S (29 ± 5%) than in Group WS (43 ± 6%) (P < 0.001).
","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan. Electronic address: y_takahashi@sapmed.ac.jp.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Tokinaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Michitaka', 'Initials': 'M', 'LastName': 'Edanaga', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Kenichiro', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tada', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Maki', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Thoracic Surgery, Sapporo Medical University, School of Medicine and Hospital, Sapporo, Hokkaido, Japan.'}]",The Journal of surgical research,['10.1016/j.jss.2020.08.017']
2294,32892163,Clinical outcomes of KeraVio using violet light: emitting glasses and riboflavin drops for corneal ectasia: a pilot study.,"BACKGROUND/AIMS


We developed a novel technology consisting of violet light (VL)-emitting glasses and defined the combination of VL irradiation and riboflavin treatment as KeraVio. Our goal was to evaluate the clinical results of KeraVio in patients with progressive corneal ectasia.
METHODS


Eyes were exposed to VL (375 nm, irradiance 310 μW/cm 2 )-emitting glasses for 3 hours daily for 6 months, and a riboflavin solution was administered onto the corneal epithelium six times during each 3-hour VL irradiation. The primary end point was a change in the maximum keratometry (Kmax) value over 6 months compared with that over the 1 year before baseline.
RESULTS


The efficacy of KeraVio was evaluated in 20 eyes with severe progression, and its safety was evaluated in all 40 eyes. The mean changes in Kmax over the 1 year before baseline and during the 6-month observation period were 6.03±3.41 dioptres (D) and -0.81±3.34 D, respectively (p=0.002). At 6 months, the Kmax value decreased by more than 2 D in 4 eyes (20%), remained within 2 D in 13 eyes (65%), and increased by 2 D or more in 3 eyes (15%). The corneal stromal demarcation line was identified in 16 eyes (80%), and its depth was 206.3±54.9 μm at 1 month. No significant decrease in endothelial cell density, lenticular opacity or transient corneal haze was noted.
CONCLUSION


Based on our 6-month results, daily treatment of progressive corneal ectasia with KeraVio can halt disease progression without any safety concerns.
CLINICAL TRIAL REGISTRATION NUMBER


jRCTs032180217.",2020,"No significant decrease in endothelial cell density, lenticular opacity or transient corneal haze was noted.
","['patients with progressive corneal ectasia', '20 eyes with severe progression, and its safety was evaluated in all 40 eyes', 'Eyes were exposed to VL (375\xa0nm, irradiance 310\xa0μW/cm 2 ', 'corneal ectasia']","['emitting glasses for 3\xa0hours daily for 6\xa0months, and a riboflavin solution', 'VL irradiation and riboflavin', 'riboflavin drops']","['Kmax value', 'maximum keratometry (Kmax) value', 'mean changes in Kmax', 'endothelial cell density, lenticular opacity or transient corneal haze', 'corneal stromal demarcation line']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0155135', 'cui_str': 'Corneal ectasia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C5191352', 'cui_str': '310'}]","[{'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C1510497', 'cui_str': 'Lenticular opacities'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0010038', 'cui_str': 'Corneal opacity'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",20.0,0.0406454,"No significant decrease in endothelial cell density, lenticular opacity or transient corneal haze was noted.
","[{'ForeName': 'Hidenaga', 'Initials': 'H', 'LastName': 'Kobashi', 'Affiliation': 'Department of Ophthalmology, Keio University, School of Medicine, Shinjuku, Tokyo, Japan himon@hotmail.co.jp.'}, {'ForeName': 'Hidemasa', 'Initials': 'H', 'LastName': 'Torii', 'Affiliation': 'Department of Ophthalmology, Keio University, School of Medicine, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Toda', 'Affiliation': 'Department of Ophthalmology, Keio University, School of Medicine, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Kondo', 'Affiliation': 'Department of Ophthalmology, Keio University, School of Medicine, Shinjuku, Tokyo, Japan.'}, {'ForeName': 'Motozumi', 'Initials': 'M', 'LastName': 'Itoi', 'Affiliation': 'Dogenzaka Itoi Eye Clinic, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Tsubota', 'Affiliation': 'Department of Ophthalmology, Keio University, School of Medicine, Shinjuku, Tokyo, Japan.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-316974']
2295,32892178,Inhaled nitric oxide (iNO) for preventing prematurity-related bronchopulmonary dysplasia (BPD): 7-year follow-up of the European Union Nitric Oxide (EUNO) trial.,"Objectives Most studies of inhaled nitric oxide (iNO) for prevention of bronchopulmonary dysplasia (BPD) in premature infants have focused on short-term mortality and morbidity. Our aim was to determine the long-term effects of iNO. Methods A 7-year follow-up was undertaken of infants entered into a multicenter, double-blind, randomized, placebo-controlled trial of iNO for prevention of BPD in premature infants born between 24 and 28 weeks plus six days of gestation. At 7 years, survival and hospital admissions since the 2-year follow-up, home oxygen therapy in the past year, therapies used in the previous month and growth assessments were determined. Questionnaires were used to compare general health, well-being, and quality of life. Results A total of 305 children were assessed. No deaths were reported. Rates of hospitalization for respiratory problems (6.6 vs. 10.5%, iNO and placebo group, respectively) and use of respiratory medications (6.6 vs. 9.2%) were similar. Two patients who received iNO and one who received placebo had received home oxygen therapy. There were no significant differences in any questionnaire-documented health outcomes. Conclusions iNO for prevention of BPD in very premature infants with respiratory distress did not result in long-term benefits or adverse long-term sequelae. In the light of current evidence, routine use of iNO cannot be recommended for prevention of BPD in preterm infants.",2020,"Rates of hospitalization for respiratory problems (6.6 vs. 10.5%, iNO and placebo group, respectively) and use of respiratory medications (6.6 vs. 9.2%) were similar.","['preterm infants', 'premature infants', 'prematurity-related bronchopulmonary dysplasia (BPD', 'premature infants born between 24 and 28\xa0weeks plus six days of gestation', '305 children']","['Inhaled nitric oxide (iNO', 'inhaled nitric oxide (iNO', 'placebo', 'home oxygen therapy']","['questionnaire-documented health outcomes', 'survival and hospital admissions since the 2-year follow-up, home oxygen therapy', 'general health, well-being, and quality of life', 'Rates of hospitalization for respiratory problems']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",305.0,0.299218,"Rates of hospitalization for respiratory problems (6.6 vs. 10.5%, iNO and placebo group, respectively) and use of respiratory medications (6.6 vs. 9.2%) were similar.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Decobert', 'Affiliation': 'Centre Hospitalier Intercommunal de Créteil, Créteil, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'University of Leicester Centre for Medicine, Leicester, UK.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'University of Oulu and Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Helmut D', 'Initials': 'HD', 'LastName': 'Hummler', 'Affiliation': 'Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Baldvin', 'Initials': 'B', 'LastName': 'Jonsson', 'Affiliation': 'Karolinska University Hospital and Institute, Stockholm, Sweden.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sánchez Luna', 'Affiliation': 'Hospital General Universitario ""Gregorio Marañón,"" Madrid, Spain.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Van Overmeire', 'Affiliation': 'Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Virgilio P', 'Initials': 'VP', 'LastName': 'Carnielli', 'Affiliation': 'Polytechnical University of Marche, Ancona, Italy.'}, {'ForeName': 'Jim L', 'Initials': 'JL', 'LastName': 'Potenziano', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Mercier', 'Affiliation': 'Université Paris Diderot, Paris, France.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0164']
2296,32901235,Does preoperative paracetamol reduce pain after dental treatment? A randomized controlled double-blind study.,"OBJECTIVE


The present study compared the efficacy of preoperative administration of paracetamol and placebo in reducing postoperative pain after routine dental treatment in children. The primary objective was to compare postoperative pain level between the groups. The secondary objective was to identify other factors that can influence postoperative pain.
METHOD AND MATERIALS


A prospective, placebo-controlled parallel-group trial was conducted on two groups of children aged 5 to 12 years. One hundred and two children participated in the study, 51 in each group, 58 boys (56.9%) and 44 girls (43.1%). The average age was 7 ± 1.72 years, with no difference in age and sex between the groups. The study group received paracetamol (15 mg/kg) and the control group received placebo 15 minutes before dental treatment. Pretreatment baseline anxiety was recorded. Postoperative data were collected immediately at the end of the treatment, and by phone 2.5 hours after taking the remedy.
RESULTS


The groups showed no difference in postoperative pain immediately after the treatment and 1.5 hours after treatment. The pain score was higher among children who received stainless steel crowns and combinations of crowns, pulpectomy, and extractions.
CONCLUSION


Preoperative use of paracetamol has the same preemptive analgesic effect as placebo in pediatric patients who receive routine dental treatment.
CLINICAL RELEVANCE


Postoperative pain can influence the willingness of children to receive consecutive treatments. Dental practitioners should prevent postoperative pain and recommend analgesia when necessary. Pain is expected after performing stainless steel crowns, pulpectomies, and extractions. The current study confirms that preoperative paracetamol has no beneficial effect.",2020,"The pain score was higher among children who received stainless steel crowns and combinations of crowns, pulpectomy, and extractions.
","['children', 'One hundred and two children participated in the study, 51 in each group, 58 boys (56.9%) and 44 girls (43.1', 'pediatric patients who receive routine dental treatment', 'two groups of children aged 5 to 12 years']","['placebo', 'paracetamol and placebo', 'paracetamol']","['Postoperative data', 'postoperative pain level', 'Pain', 'pain score', 'postoperative pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",102.0,0.132331,"The pain score was higher among children who received stainless steel crowns and combinations of crowns, pulpectomy, and extractions.
","[{'ForeName': 'Avia', 'Initials': 'A', 'LastName': 'Fux-Noy', 'Affiliation': ''}, {'ForeName': 'Yifat', 'Initials': 'Y', 'LastName': 'Bendahan', 'Affiliation': ''}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Ungar', 'Affiliation': ''}, {'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Shmueli', 'Affiliation': ''}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Halperson', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Ram', 'Affiliation': ''}, {'ForeName': 'Moti', 'Initials': 'M', 'LastName': 'Moskovitz', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45101']
2297,32901239,Fiberglass crowns versus preformed metal crowns in pulpotomized primary molars: a randomized controlled clinical trial.,"OBJECTIVE


To evaluate the clinical performance of the fiberglass ""Figaro"" crowns compared to preformed metal crowns (PMCs) in pulpotomized primary molars in children.
METHOD AND MATERIALS


This split-mouth controlled randomized clinical study was performed on ten childrens, aged from 4 to 6 years, who needed complete oral rehabilitation under general anesthesia and had one pair or two pairs of their primary molars requiring pulpotomy. After pulp therapy, the teeth were randomly assigned to Figaro or PMC crown groups. Modified United States Public Health Service (USPHS) criteria were used to evaluate crown retention, marginal integration, crown discoloration, secondary caries, and gingival status, at 3 and 6 months. The data were analyzed using the chi-square test with Monte Carlo (MC) correction and McNemar (McN) test at a significance level of .05.
RESULTS


Ten patients (three boys, 30%; seven girls, 70%) with a mean age of 4.65 ± 0.709 years participated in this study. At 3 months follow-up, there was no significant difference between the groups, but at 6 months follow-up, Figaro crowns showed significant changes from intact crown to either chipped or large loss, whereas all PMCs were found intact (χ2 = 14.545, P[MC] = 0.000). There was also significant deterioration in Figaro crowns' color after 6 months (χ2[McN] = 8.1, P = .004).
CONCLUSION


PMCs were more durable than Figaro crowns, which showed significant deterioration after the 6-month follow-up period.",2020,"At 3 months follow-up, there was no significant difference between the groups, but at 6 months follow-up, Figaro crowns showed significant changes from intact crown to either chipped or large loss, whereas all PMCs were found intact (χ2 = 14.545, P[MC] = 0.000).","['ten childrens, aged from 4 to 6 years, who needed complete oral rehabilitation under general anesthesia and had one pair or two pairs of their primary molars requiring pulpotomy', 'Ten patients (three boys, 30%; seven girls, 70%) with a mean age of 4.65 ± 0.709 years participated in this study', 'pulpotomized primary molars', 'pulpotomized primary molars in children']","['Fiberglass crowns versus preformed metal crowns', 'fiberglass ""Figaro"" crowns compared to preformed metal crowns (PMCs']",[],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C3544227', 'cui_str': 'Complete oral rehabilitation'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0060317', 'cui_str': 'Fiberglass'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0025552', 'cui_str': 'Metal'}]",[],,0.0365439,"At 3 months follow-up, there was no significant difference between the groups, but at 6 months follow-up, Figaro crowns showed significant changes from intact crown to either chipped or large loss, whereas all PMCs were found intact (χ2 = 14.545, P[MC] = 0.000).","[{'ForeName': 'Laila M', 'Initials': 'LM', 'LastName': 'El-Habashy', 'Affiliation': ''}, {'ForeName': 'Omar A', 'Initials': 'OA', 'LastName': 'El Meligy', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45169']
2298,32901242,Evaluation of aromatherapy on success rate of inferior alveolar nerve block in teeth with irreversible pulpitis: a prospective randomized clinical trial.,"OBJECTIVE


This prospective, block randomized clinical trial was conducted to evaluate the effect of aromatherapy on the success rate of inferior alveolar nerve block (IANB) in teeth with irreversible pulpitis.
METHOD AND MATERIALS


In this clinical trial, 46 patients fulfilling the inclusion criteria were randomly divided into two equal groups: group I (n = 22) received IANB in a closed operatory without any fragrance, whereas group II (n = 24) received IANB in a separate closed operatory saturated with lavender fragrance using a candle warmer. The modified dental anxiety scale (MDAS) for anxiety and visual analog scale (VAS) for pain were recorded preoperatively as well as during access cavity preparation. For MDAS, a total score of more than 18 was considered as tremendously anxious or dental phobic. No or mild pain on VAS was considered as success. Data were analyzed using paired t test and independent sample t test. P < .05 was considered as statistically significant.
RESULTS


Difference in mean VAS (P = .749) and MDAS (P = 1.000) between both the groups was statistically nonsignificant. However there was a statistically significant difference in mean VAS (P = .000) and MDAS (P = .001) during access opening.
CONCLUSION


Lavender aromatherapy can be used successfully to alleviate dental anxiety as well as to increase the anesthetic success rate of IANB in teeth with irreversible pulpitis.",2020,"RESULTS


Difference in mean VAS (P = .749) and MDAS (P = 1.000) between both the groups was statistically nonsignificant.","['teeth with irreversible pulpitis', '46 patients fulfilling the inclusion criteria']","['IANB in a separate closed operatory saturated with lavender fragrance using a candle warmer', 'Lavender aromatherapy', 'aromatherapy', 'IANB in a closed operatory without any fragrance']","['success rate of inferior alveolar nerve block', 'mild pain', 'MDAS', 'success rate of inferior alveolar nerve block (IANB', 'modified dental anxiety scale (MDAS) for anxiety and visual analog scale (VAS) for pain', 'mean VAS']","[{'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C1850568', 'cui_str': 'Nakajo-Nishimura syndrome'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}]","[{'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",46.0,0.0564291,"RESULTS


Difference in mean VAS (P = .749) and MDAS (P = 1.000) between both the groups was statistically nonsignificant.","[{'ForeName': 'Ganesh R', 'Initials': 'GR', 'LastName': 'Jadhav', 'Affiliation': ''}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Mittal', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45172']
2299,32901243,Bleaching sensitivity with a desensitizing in-office bleaching gel: a randomized double-blind clinical trial.,"OBJECTIVES


This split-mouth study assessed the bleaching sensitivity (risk and intensity) and color change after in-office bleaching using a desensitizing-containing (5% potassium nitrate) and a desensitizing-free 35% hydrogen peroxide gel. The null hypothesis was that there would be no differences between study groups regarding bleaching sensitivity.
METHOD AND MATERIALS


Sixty patients participated in this split-mouth study. The subjects received desensitizing-containing hydrogen peroxide in half of the maxillary arch, and the other half received a desensitizing-free hydrogen peroxide, defined by random sequence, in two dental bleaching sessions. The bleaching sensitivity was evaluated during bleaching and from 1 h to 48 h after each bleaching session using a visual analog scale and numeric rating scale; the McNemar test, the Wilcoxon signed-rank test, and the Student-Newman-Keuls test were used for statistical analysis. The color was measured at baseline and 30 days post-bleaching, evaluated with paired t tests (P = .05).
RESULTS


Statistically similar risks of bleaching sensitivity were observed (P = 1.000), but the intensity of bleaching sensitivity was lower (P < .011) on average by 1.32 visual analog scale units in the group bleached with the desensitizer-containing gel during up to 24 h assessment times. No statistical difference in color change was observed between groups (P > .321).
CONCLUSION


The incorporation of 5% potassium nitrate into in-office bleaching gels does not reduce the risk of bleaching sensitivity, but it reduces its intensity slightly without jeopardizing color change.",2020,"No statistical difference in color change was observed between groups (P > .321).
",['Sixty patients participated in this split-mouth study'],"['desensitizing-containing (5% potassium nitrate) and a desensitizing-free 35% hydrogen peroxide gel', 'desensitizing in-office bleaching gel', 'desensitizing-containing hydrogen peroxide', 'desensitizing-free hydrogen peroxide']","['intensity of bleaching sensitivity', 'color change', 'bleaching sensitivity', 'risk of bleaching sensitivity', 'bleaching sensitivity (risk and intensity) and color change', '\ufeffBleaching sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0442603', 'cui_str': 'Office'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",60.0,0.0834882,"No statistical difference in color change was observed between groups (P > .321).
","[{'ForeName': 'Bianca Medeiros', 'Initials': 'BM', 'LastName': 'Maran', 'Affiliation': ''}, {'ForeName': 'Laína', 'Initials': 'L', 'LastName': 'Vochikovski', 'Affiliation': ''}, {'ForeName': 'Diego Rafael de Andrade', 'Initials': 'DRA', 'LastName': 'Hortkoff', 'Affiliation': ''}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Stanislawczuk', 'Affiliation': ''}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': ''}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45173']
2300,32901302,Is fasting still necessary prior to contrast-enhanced computed tomography? A randomized clinical study.,"OBJECTIVES


There is very limited evidence to support the common practice of preparative fasting prior to contrast-enhanced computerized tomography (CT). This study examined the effect of withholding fasting orders, prior to contrast-enhanced CT, on the incidence of aspiration pneumonitis and adverse gastrointestinal symptoms.
METHODS


This randomized controlled trial enrolled hospitalized patients referred for non-emergency, contrast-enhanced CT scan to either at least 4 h of fasting or to an unrestricted consumption of liquids and solids up to the time of CT. The primary outcome was incidence of aspiration pneumonitis and the secondary outcomes were rates of adverse gastrointestinal symptoms (nausea and/or vomiting).
RESULTS


After excluding participants with incomplete follow-up, a total of 1080 participants were assigned to the fasting group and 1011 were assigned to the non-fasting group. Aspiration pneumonitis was not identified in either group. The mean time of fasting in the fasting group was 8.4 ± 1.6 h. Rates of nausea and vomiting were not statistically different between the fasting group compared with the non-fasting group, 6.6% vs. 7.6% (p = 0.37) and 2.6% vs. 3.0% (p = 0.58), respectively. A subgroup analysis of patients who were required to drink oral contrast agent (n = 1257) showed that rates of nausea and vomiting were not statistically different between the fasting and non-fasting groups, 6.8% vs. 8.0% (p = 0.42) and 2.6% vs. 3.6% (p = 0.3), respectively.
CONCLUSIONS


Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT03533348 KEY POINTS: • Is fasting necessary prior to contrast-enhanced computed tomography (CT)? • In this randomized clinical study including 2091 participants referred to non-emergency contrast-enhanced CT scan, withholding preparative fasting was not associated with a greater risk of aspiration pneumonitis or clinically significant increase in rates of adverse gastrointestinal symptoms. • Eating and drinking prior to contrast-enhanced CT can be allowed and are not associated with an increased risk of aspiration pneumonitis.",2020,"CONCLUSIONS


Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms.
","['After excluding participants with incomplete follow-up, a total of 1080 participants were assigned to the fasting group and 1011 were assigned to the non-fasting group', 'enrolled hospitalized patients referred for non-emergency, contrast-enhanced CT scan to either at least 4\xa0h of fasting or to an unrestricted consumption of liquids and solids up to the time of CT', '2091 participants referred to non-emergency contrast-enhanced CT scan, withholding preparative fasting']",[],"['Aspiration pneumonitis', 'rates of nausea and vomiting', 'incidence of aspiration pneumonitis', 'mean time of fasting', 'nausea and vomiting', 'risk of aspiration pneumonitis', 'rates of adverse gastrointestinal symptoms', 'rates of adverse gastrointestinal symptoms (nausea and/or vomiting']","[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5192768', 'cui_str': '1080'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",2091.0,0.0465246,"CONCLUSIONS


Withholding fasting orders prior to contrast-enhanced CT was not associated with a greater risk of aspiration pneumonitis or a significant increase in rates of adverse gastrointestinal symptoms.
","[{'ForeName': 'Ziv', 'Initials': 'Z', 'LastName': 'Neeman', 'Affiliation': 'Department of Radiology, Emek Medical Center, Afula, Israel.'}, {'ForeName': 'Mayasa', 'Initials': 'M', 'LastName': 'Abu Ata', 'Affiliation': 'Department of Medicine D, Emek Medical Center, 18341, Afula, Israel.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Touma', 'Affiliation': 'Department of Medicine D, Emek Medical Center, 18341, Afula, Israel.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Saliba', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ofra', 'Initials': 'O', 'LastName': 'Barnett-Griness', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Gralnek', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Rock', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Naiel', 'Initials': 'N', 'LastName': 'Bisharat', 'Affiliation': 'Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel. bisharat_na@clalit.org.il.'}]",European radiology,['10.1007/s00330-020-07255-0']
2301,32901316,Intrathecal treatment trial of rituximab in progressive MS: results after a 2-year extension.,"OBJECTIVES


To evaluate the effect of intrathecally (IT) delivered rituximab as a therapeutic intervention for progressive multiple sclerosis (PMS) during a 3-year follow-up period.
METHODS


Participants of a 1-year open-label phase 1b study of IT delivered rituximab to patients with PMS were offered extended treatment with follow-up for an additional 2 years. During the extension phase, treatment with 25 mg rituximab was administered every 6 months via a subcutaneous Ommaya reservoir connected to the right frontal horn with a ventricular catheter.
RESULTS


Mild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion. During the entire 3-year period, two cases of low-virulent bacterial meningitis occurred, which were successfully treated. Walking speed deteriorated significantly during the study.
CONCLUSIONS


IT administration of rituximab via a ventricular catheter was well tolerated. Considering the meningitis cases, the risk of infection was not negligible. The continued loss of walking speed indicates that IT rituximab was not able to stop disease progression.
CLASSIFICATION OF EVIDENCE


This study provides class IV evidence that intraventricularly administered rituximab in progressive MS is associated with a risk for bacterial meningitis and does not halt disease progression.
EU CLINICAL TRIAL REGISTER


EudraCT; 2008-002626-11 and 2012-000721-53.",2020,Mild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion.,"['progressive multiple sclerosis (PMS', 'Participants of a 1-year open-label phase 1b study of IT delivered rituximab to patients with PMS', 'progressive MS', 'EudraCT; 2008-002626-11 and 2012-000721-53']","['intrathecally (IT) delivered rituximab', 'rituximab']","['Walking speed deteriorated', 'tolerated', 'moderate vertigo and nausea']","[{'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",14.0,0.0298035,Mild to moderate vertigo and nausea occurred in 4 out of 14 participants as temporary adverse events associated with IT rituximab infusion.,"[{'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Bergman', 'Affiliation': 'Department of Clinical Science, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Burman', 'Affiliation': 'Department of Neurosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Bergenheim', 'Affiliation': 'Department of Clinical Science, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Svenningsson', 'Affiliation': 'Department of Clinical Science, Umeå University, Umeå, Sweden. anders.svenningsson@ki.se.'}]",Journal of neurology,['10.1007/s00415-020-10210-0']
2302,32901323,Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis with Generalized Peritonitis.,"INTRODUCTION


Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation in patients with perforated diverticulitis and generalized peritonitis was established at our Institution in 2006 and has been published. The concept was adopted in other hospitals and published as a case series. This is the first prospectively controlled randomized study comparing DCS and conventional treatment (Group C) in this setting.
METHODS


All consecutive patients from 2013 to 2018 with indication for surgery were screened and randomized to Group DCS or Group C. The primary outcome was the rate of reconstructed bowel at discharge and at 6 month. Informed consent was obtained. The trial was approved by the local ethics committee and registered at CinicalTrials.gov: NCT04034407.
RESULTS


A total of 56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III (n = 14, 67%) or IV (n = 7, 33%), and a median (range) age of 66 (42-92), Mannheim Peritonitis Index of 25 (12-37) and Charlson Comorbidity Index of 3 (0-10) were intraoperatively randomized and treated as Group DCS (n = 13) or Group C (n = 8). Per protocol analysis: A primary anastomosis without ileostomy (PA) was performed in 92% (11/12) patients in Group DCS at the second-look operation, one patient died before second look, and one underwent a Hartmann procedure (HP). In Group C 63% (5/8) patients received a PA and 38% (3/8) patients a HP. Two patients in Group C, but none in Group DCS experienced anastomotic leakage (AI). ICU and hospital stay was median (range) 2 (1-10) and 17.5 (12-43) in DCS and 2 (1-62) and 22 (13-65) days in group C. In Group DCS 8% (1/12) patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge. The odds ratio (95% confidence interval) for discharge with a stoma is 0.068 (0.005-0.861). Intent to treat analysis: A PA was performed in 90% (9/10) of patients randomized to DCS, one patient died before the second look, and one patient received a HP. In group C, 70% (7/10) were treated with PA and 30% (3/10) with HP. 29% (2/7) experienced AI treated with protective ileostomy. In group DCS, 9% (1/11) were discharged with a stoma versus 40% (4/10) in group C (p = 0.14, n.s.). The odds ratio for discharge with a stoma is 0.139 (0.012-1.608).
CONCLUSION


This is the first prospectively randomized controlled study showing that damage control surgery in perforated diverticulitis Hinchey III and IV enhances reconstruction of bowel continuity and can reduce the stoma rate at discharge.",2020,"patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge.","['Perforated Diverticulitis with Generalized Peritonitis', '56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III (n\u2009=\u200914, 67%) or IV (n\u2009=\u20097, 33%), and a median (range) age of 66 (42-92), Mannheim Peritonitis Index of 25 (12-37) and Charlson Comorbidity Index of 3 (0-10', 'All consecutive patients from 2013 to 2018 with indication for surgery', 'patients with perforated diverticulitis and generalized peritonitis']","['DCS', 'Hartmann procedure (HP', 'Damage Control Surgery', 'HP', 'Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation', 'Group DCS', 'primary anastomosis without ileostomy (PA', 'Group DCS or Group C']","['rate of reconstructed bowel at discharge and at 6\xa0month', 'anastomotic leakage (AI', 'odds ratio for discharge with a stoma', 'ICU and hospital stay']","[{'cui': 'C0544794', 'cui_str': 'Perforated diverticulitis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031154', 'cui_str': 'Peritonitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0400084', 'cui_str': 'Hartmann operation, rectal resection'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0441837', 'cui_str': 'Group C'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",56.0,0.0719085,"patients was discharged with a stoma versus 57% (4/7) in Group C (p = 0.038, n.s., α = 0.025); one patient died before discharge.","[{'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kafka-Ritsch', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria. reinhold.kafka-ritsch@tirol-kliniken.at.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Zitt', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Perathoner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gasser', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Kaufman', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Czipin', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Aigner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Öfner', 'Affiliation': 'Department of Visceral, Transplant and Thoracic Surgery, Centre for Operative Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.'}]",World journal of surgery,['10.1007/s00268-020-05762-1']
2303,32901330,Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial.,"INTRODUCTION


In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial.
METHODS


In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best supportive care. Treatment-related AESIs and time to first occurrence of AESIs were summarized. Treatment-related TEAEs by age, sex, and BMI were also summarized.
RESULTS


A total of 266 patients (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group had at least one treatment-related TEAE; the mean relative dose intensity was 92% and 98%, respectively. In the fruquintinib group, the most common (in > 40% of patients) treatment-related AESIs were hypertension (55.4%), palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR)] (49.3%), and proteinuria (42.1%). The most common treatment-related grade ≥ 3 AESIs (≥ 3% of patients) were hypertension (21.2%), HFSR (10.8%), and proteinuria (3.2%); the median time to onset of these events was 10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib.
CONCLUSIONS


The most common treatment-related grade ≥ 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
TRIAL REGISTRATION


Clinical Trials identifier NCT02314819.",2020,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
","['eligible Chinese patients', 'Chinese Patients with Previously Treated Metastatic Colorectal Cancer', 'Chinese patients with metastatic colorectal cancer (mCRC']","['placebo', 'placebo plus best supportive care']","['adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI', 'palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR', 'HFSR', 'safety profile and AESIs', 'hypertension']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",266.0,0.204187,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Tongji University East Hospital, Shanghai, China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Shanghai Medical College, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Nantong Cancer Hospital, Nantong, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Provincial Hospital, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ""Department of Medical Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The Fifth Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Shanghai Jiao Tong University Affiliated First People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Peiguo', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Haihui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Liuzhou Worker's Hospital, Liuzhou, China.""}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Beijing University ShenZhen Hospital, Beijing University, Shenzhen, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Xuzhou Medical College, Xuzhou Medical College, Xuzhou, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Rubing', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Center of Jinling Hospital, Nanjing, China. shukui_qin123@hotmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01477-w']
2304,32901469,Serum vitamin D level may be associated with body weight and body composition in male adolescents; a longitudinal study.,"INTRODUCTION


The prevalence of both obesity and vitamin D deficiency has been dramatically increased worldwide.
AIM


This study aimed to investigate the association between vitamin D serum level and anthropometric indices of overweight and obese male adolescents at baseline and after 18 weeks of a weight reduction intervention.
MATERIAL AND METHODS


This study was carried out on 90 male students aged 12 to 16 years who were randomly selected from two schools in Tehran, Iran. The participants were assigned to two groups with high and low vitamin D level based on their serum vitamin D levels at baseline. Five ml blood samples were collected at the baseline and after the 18 weeks of a weight reduction intervention. Height, weight, body mass index (BMI), body fat percent and body muscle percent were measured using a bio impedance analysis (BIA) scale.
RESULTS


Vitamin D level in non-obese adolescents was significantly higher than the obese participants (44.01 vs 37.67 ng/dl, p < 0.04). However, there was no significant correlation between changes of vitamin D level and anthropometric measurements after 18 weeks. Adjusting the effect of age did not alter the association. Further adjustments for physical activity, dietary intake of vitamin D, and fat and muscle percentage had no effect on the results.
CONCLUSIONS


The serum level of vitamin D was negatively associated with obesity, but not with short-term changes of anthropometric measurements in male adolescents.",2020,"Further adjustments for physical activity, dietary intake of vitamin D, and fat and muscle percentage had no effect on the results.
","['overweight and obese male adolescents at baseline and after 18 weeks of a weight reduction intervention', 'male adolescents', '90 male students aged 12 to 16 years who were randomly selected from two schools in Tehran, Iran']",[],"['Vitamin D level', 'Height, weight, body mass index (BMI), body fat percent and body muscle percent', 'vitamin D level and anthropometric measurements', 'Serum vitamin D level', 'serum level of vitamin D', 'serum vitamin D levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",90.0,0.0475553,"Further adjustments for physical activity, dietary intake of vitamin D, and fat and muscle percentage had no effect on the results.
","[{'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Doaei', 'Affiliation': 'Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Jarrahi', 'Affiliation': 'Center for Cancer Epidemiology, West Asia Organizationfor Cancer Prevention, Sabzevar University of Medical Sciences, Iran.'}, {'ForeName': 'Saheb', 'Initials': 'S', 'LastName': 'Torki', 'Affiliation': 'Department of Nutrition, Faculty of Nutrition Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Rulollah', 'Initials': 'R', 'LastName': 'Haghshenas', 'Affiliation': 'Department of Physical Education, Semnan University, Semnan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jamshidi', 'Affiliation': 'Department of Physical Education, Semnan University, Semnan, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Moslem', 'Affiliation': 'Iranian Research Center on Healthy Aging, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghorat', 'Affiliation': 'Non-Communicable Diseases Research Center, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Khodabakhshi', 'Affiliation': 'Department of Nutrition, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Gholamalizadeh', 'Affiliation': 'Student Research Committee, Cancer Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]","Pediatric endocrinology, diabetes, and metabolism",['10.5114/pedm.2020.97466']
2305,32901526,Evaluation and Clinical Comparison Studies on Liposomal and Non-Liposomal Ascorbic Acid  (Vitamin C)  and their Enhanced Bioavailability.,"The aim of present study was to evaluate the oral bioavailability of liposomal vitamin C and non-liposomal vitamin C in healthy, adult, human subjects under fasting conditions through an open label, randomized, single dose, two-treatment, two sequence, two-period, two way crossover, study. The vitamin C loaded liposome was well characterized using transmission electron microscopy (TEM), dynamic light scattering (DLS) and zeta potential measurements for evaluating morphology, particle size and stabilities, respectively. Microscopic image shows the core type structure which confirms the characteristic pattern of liposome. The encapsulation efficiency (EE%) and the particle size were 65.85 ± 1.84% and below 100 nm respectively. The results of the clinical studies of liposomal vitamin C by oral delivery to be 1.77 times more bioavailable than non-liposomal vitamin C. The Liposomal Vitamin C demonstrated higher values of C max , AUC 0-t  and AUC 0-∞  related to non-liposomal Vitamin C due to liposomal encapsulation. No adverse events were reported. It could be concluded that, liposomal encapsulated ascorbic acid (vitamin c) shows well organized morphological pattern, uniform particle size and highly efficient which leads to have enhanced bioavailability.",2020,"The Liposomal Vitamin C demonstrated higher values of C max , AUC 0-t  and AUC 0-∞  related to non-liposomal Vitamin C due to liposomal encapsulation.","['healthy, adult, human subjects under fasting conditions']","['Liposomal and Non-Liposomal Ascorbic Acid  (Vitamin C', 'Liposomal Vitamin C', 'liposomal encapsulated ascorbic acid (vitamin c', 'liposomal vitamin C', 'liposomal vitamin C and non-liposomal vitamin C']","['encapsulation efficiency (EE%) and the particle size', 'adverse events', 'C max , AUC 0-t  and AUC', 'oral bioavailability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0377385,"The Liposomal Vitamin C demonstrated higher values of C max , AUC 0-t  and AUC 0-∞  related to non-liposomal Vitamin C due to liposomal encapsulation.","[{'ForeName': 'Sreerag', 'Initials': 'S', 'LastName': 'Gopi', 'Affiliation': 'Centre for Innovations and Technologies (CIT), ADSO Naturals Private Limited, D436, 14th cross, Peenya Industrial Area, Peenya 2nd Stage, Bangalore-560058, India.'}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Balakrishnan', 'Affiliation': 'Centre for Innovations and Technologies (CIT), ADSO Naturals Private Limited, D436, 14th cross, Peenya Industrial Area, Peenya 2nd Stage, Bangalore-560058, India.'}]",Journal of liposome research,['10.1080/08982104.2020.1820521']
2306,32901611,Thulium laser transurethral vaporesection versus transurethral resection of the prostate for benign prostatic obstruction: the UNBLOCS RCT.,"BACKGROUND


Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction (BPO). Thulium laser transurethral vaporesection of the prostate (ThuVARP) vaporises and resects the prostate using a technique similar to TURP. The small amount of existing literature suggests that there may be potential advantages of ThuVARP over TURP.
OBJECTIVE


To determine whether or not the outcomes from ThuVARP are equivalent to the outcomes from TURP in men with BPO treated in the NHS.
DESIGN


A multicentre, pragmatic, randomised controlled parallel-group trial, with an embedded qualitative study and economic evaluation.
SETTING


Seven UK centres - four university teaching hospitals and three district general hospitals.
PARTICIPANTS


Men aged ≥ 18 years who were suitable to undergo TURP, presenting with bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO.
INTERVENTIONS


Patients were randomised 1 : 1 to receive TURP or ThuVARP and remained blinded.
MAIN OUTCOME MEASURES


Two co-primary outcomes - patient-reported International Prostate Symptom Score (IPSS) and clinical measure of maximum urine flow rate (Qmax) at 12 months post surgery.
RESULTS


In total, 410 men were randomised, 205 to each arm. The two procedures were equivalent in terms of IPSS [adjusted mean difference 0.28 points higher for ThuVARP (favouring TURP), 95% confidence interval (CI) -0.92 to 1.49 points]. The two procedures were not equivalent in terms of Qmax (adjusted mean difference 3.12 ml/second in favour of TURP, 95% CI 0.45 to 5.79 ml/second), with TURP deemed superior. Surgical outcomes, such as complications and blood transfusion rates, and hospital stay were similar for both procedures. Patient-reported urinary and sexual symptoms were also similar between the arms. Qualitative interviews indicated similar patient experiences with both procedures. However, 25% of participants in the ThuVARP arm did not undergo their randomised allocation, compared with 2% of participants in the TURP arm. Prostate cancer was also detected less frequently from routine histology after ThuVARP (65% lower odds of detection) in an exploratory analysis. The adjusted mean differences between the arms were similar for secondary care NHS costs (£9 higher for ThuVARP, 95% CI -£359 to £376) and quality-adjusted life-years (0.01 favouring TURP, 95% CI -0.04 to 0.01).
LIMITATIONS


Complications were recorded in prespecified categories; those not prespecified were excluded owing to variable reporting. Preoperative Qmax and IPSS data could not be collected for participants with indwelling catheters, making adjustment for baseline status difficult.
CONCLUSIONS


TURP was superior to ThuVARP in terms of Qmax, although both operations resulted in a Qmax considered clinically successful. ThuVARP also potentially resulted in lower detection rates of prostate cancer as a result of the smaller volume of tissue available for histology. Length of hospital stay after ThuVARP, anticipated to be a key benefit, was equal to that after TURP in this trial. Overall, both ThuVARP and TURP were effective procedures for BPO, with minor benefits in favour of TURP. Therefore, the results suggest that it may be appropriate that new treatment alternatives continue to be compared with TURP.
FUTURE WORK


Longer-term follow-up to assess reoperation rates over time, and research into the comparative effectiveness of ThuVARP and TURP in large prostates.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN00788389.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 41. See the NIHR Journals Library website for further project information.",2020,"The adjusted mean differences between the arms were similar for secondary care NHS costs (£9 higher for ThuVARP, 95% CI -£359 to £376) and quality-adjusted life-years (0.01 favouring TURP, 95% CI -0.04 to 0.01).
","['men with BPO treated in the NHS', 'benign prostatic obstruction (BPO', 'Men aged ≥\u200918 years who were suitable to undergo TURP, presenting with bothersome lower urinary tract symptoms (LUTS) or urinary retention secondary to BPO', 'participants with indwelling catheters', '410 men were randomised, 205 to each arm', 'Seven UK centres - four university teaching hospitals and three district general hospitals', 'benign prostatic obstruction']","['Transurethral resection of the prostate (TURP', 'Thulium laser transurethral vaporesection versus transurethral resection', 'TURP or ThuVARP', 'ThuVARP', 'TURP', 'ThuVARP and TURP', 'Thulium laser transurethral vaporesection of the prostate (ThuVARP']","['Prostate cancer', 'secondary care NHS costs', 'Preoperative Qmax and IPSS data', 'Length of hospital stay', 'quality-adjusted life-years', 'urinary and sexual symptoms', 'complications and blood transfusion rates, and hospital stay', 'International Prostate Symptom Score (IPSS) and clinical measure of maximum urine flow rate (Qmax', 'Qmax']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0268889', 'cui_str': 'Prostatic obstruction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0007439', 'cui_str': 'In-Dwelling Catheters'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}]",410.0,0.192232,"The adjusted mean differences between the arms were similar for secondary care NHS costs (£9 higher for ThuVARP, 95% CI -£359 to £376) and quality-adjusted life-years (0.01 favouring TURP, 95% CI -0.04 to 0.01).
","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian M', 'Initials': 'SM', 'LastName': 'Noble', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Aideen', 'Initials': 'A', 'LastName': 'Ahern', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sara T', 'Initials': 'ST', 'LastName': 'Brookes', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Cotterill', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Lyndsey', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Rafiyah', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Aida Moure', 'Initials': 'AM', 'LastName': 'Fernandez', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Page', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Satchi', 'Initials': 'S', 'LastName': 'Swami', 'Affiliation': 'Urology Department, Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Hashim', 'Initials': 'H', 'LastName': 'Hashim', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24410']
2307,32901672,"Aprepitant plus palonosetron for the prevention of postoperative nausea and vomiting after breast cancer surgery: a double blind, randomized trial.","OBJECTIVES


To evaluate the addition of a fourth antiemetic intervention in patients at high risk for postoperative nausea and vomiting (PONV).
METHODS


High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy were randomly allocated in one of two groups, oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg). Patients and caregivers were blinded to the group assignments. The primary efficacy endpoints included the incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period. ClinicalTrials.gov: NCT02431286.
RESULTS


One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group P. No patient presented with nausea or vomiting in the first 2 hours after surgery. From the 2nd to the 6th hour, the incidence of PONV was 8.33% in group A and 9.30% in group P. In the first 24 hours, the incidence of PONV was 27.08% in the group A and 20.93% in group P. From the 24th to the 48th hour, the incidence of PONV was 8.33% in group A and 13.95% in group P. There were no statistically significant differences in PONV between groups.
CONCLUSION


The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population. However, the incidence of PONV was reduced in relation to the general population.",2020,The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population.,"['One hundred patients were enrolled in this study and 91 were analyzed, 48 in group A and 43 in group', 'High-risk patients (Apfel score 3 or 4) scheduled for unilateral mastectomy', 'patients at high risk for postoperative nausea and vomiting (PONV', 'after breast cancer surgery']","['oral aprepitant (oral aprepitant 80 mg, intravenous dexamethasone 8 mg, and palonosetron 0.075 mg) and oral placebo (oral placebo, intravenous dexamethasone 4 mg, and palonosetron 0.075 mg', 'Aprepitant plus palonosetron', 'antiemetic intervention']","['postoperative nausea and vomiting', 'PONV', 'incidence of nausea and vomiting, and the secondary endpoints included use of rescue antiemetics during a 48-hour postoperative period', 'incidence of PONV', 'nausea or vomiting']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C1331021', 'cui_str': 'aprepitant 80 MG'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C4517416', 'cui_str': '0.075'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0985346', 'cui_str': 'Dexamethasone 4 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",100.0,0.25619,The addition of aprepitant as a third antiemetic resulted in no significant reduction in the incidence of PONV in this population.,"[{'ForeName': 'Thiago Ramos', 'Initials': 'TR', 'LastName': 'Grigio', 'Affiliation': 'Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Angela Maria', 'Initials': 'AM', 'LastName': 'Sousa', 'Affiliation': 'Anestesia, Instituto do Cancer do Estado de Sao Paulo (ICESP), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Gabriel Guimarães Nunes', 'Initials': 'GGN', 'LastName': 'Magalhães', 'Affiliation': 'Campus Darcy Ribeiro, Faculdade Medicina, Universidade de Brasilia, Brasilia, DF, BR.'}, {'ForeName': 'Hazem Adel', 'Initials': 'HA', 'LastName': 'Ashmawi', 'Affiliation': 'Anestesiologia Experimental LIM-08, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}, {'ForeName': 'Joaquim Edson', 'Initials': 'JE', 'LastName': 'Vieira', 'Affiliation': 'Cirurgia, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, BR.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1688']
2308,32901739,Teaching cardiovascular physical examination in nursing: clinical simulation.,"OBJECTIVE


To evaluate, in Nursing students, the effect of clinical simulation as an educational strategy for learning about the cardiovascular physical examination.
METHODS


Quasi-experimental study, with the placement of 30 undergraduate nursing students, from a public university in Northeast Brazil, in two groups - intervention and control. The educational intervention consisted of a clinical simulation applied to the intervention group. The control group received only the usual class. Pre-test and post-test were applied with questions about cardiovascular physical examination for both groups. In the inferential analysis, we used chi-square or Fisher's exact tests for categorical variables; and the Student's t-test for independent samples.
RESULTS


The results showed that the difference in correct answers between the intervention and control groups was statistically significant, with a value of p of 0.05.
CONCLUSION


We concluded that the applied educational strategy had a positive effect on undergraduate nursing students to learn the cardiovascular physical examination.",2020,"The results showed that the difference in correct answers between the intervention and control groups was statistically significant, with a value of p of 0.05.
","['Quasi-experimental study, with the placement of 30 undergraduate nursing students, from a public university in Northeast Brazil, in two groups - intervention and control', 'Nursing students', 'undergraduate nursing students']",[],['correct answers'],"[{'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205202', 'cui_str': 'Corrected'}]",,0.0200612,"The results showed that the difference in correct answers between the intervention and control groups was statistically significant, with a value of p of 0.05.
","[{'ForeName': 'Renata Marinho', 'Initials': 'RM', 'LastName': 'Fernandes', 'Affiliation': 'Universidade Federal do Rio Grande do Norte. Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Ana Carolina Costa', 'Initials': 'ACC', 'LastName': 'Carino', 'Affiliation': 'Universidade Federal do Rio Grande do Norte. Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Maria Isabel da Conceição Dias', 'Initials': 'MIDCD', 'LastName': 'Fernandes', 'Affiliation': 'Universidade Estadual do Rio Grande do Norte. Caicó, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Jéssica Dantas de Sá', 'Initials': 'JDS', 'LastName': 'Tinôco', 'Affiliation': 'Universidade Estadual do Rio Grande do Norte. Caicó, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Helen Cristiny Teodoro Couto', 'Initials': 'HCTC', 'LastName': 'Ribeiro', 'Affiliation': 'Universidade Federal de São João Del Rei. Divinópolis, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Luisa Brandão de Carvalho', 'Initials': 'ALBC', 'LastName': 'Lira', 'Affiliation': 'Universidade Federal do Rio Grande do Norte. Natal, Rio Grande do Norte, Brazil.'}]",Revista brasileira de enfermagem,['10.1590/0034-7167-2019-0530']
2309,32901826,Influence of Cap Thickness on Opaque Bubble Layer Formation in SMILE: 110 Versus 140 µm.,"PURPOSE


To investigate the impact of cap thickness on the formation of an opaque bubble layer (OBL) during small incision lenticule extraction procedures.
METHODS


In total, 100 eyes from 50 patients were prospectively examined. One of two corneal cap thicknesses was randomly assigned to each eye and differed in the contralateral eye: 110 µm in one eye and 140 µm in the other. OBL area and density were quantitatively assessed.
RESULTS


The proportion of OBL areas in the anterior lenticule plane was 11.70% ± 7.35% in the 110-µm group, which was significantly higher than the 140-µm group (6.64% ± 4.68%, P < .001). For OBL areas located in the posterior lenticule plane, mean areas for the 110-µm group were also higher than those for the 140-µm group (1.32% ± 1.20% and 0.94% ± 0.59%, respectively; P = .002). Mean gray values of the OBL in the posterior lenticule plane were slightly different between the two groups (P < .001), but no significant difference in OBL of the anterior lenticule plane was observed (P = .055). Eyes with a 110-µm cap thickness had more focal OBLs, revealed by cap scanning (chi-square = 10.256, P = .001).
CONCLUSIONS


Corneal cap thickness is predictive of opaque bubble layer during small incision lenticule extraction procedures. [J Refract Surg. 2020;36(9):592-596.].",2020,"For OBL areas located in the posterior lenticule plane, mean areas for the 110-µm group were also higher than those for the 140-µm group (1.32% ± 1.20% and 0.94% ± 0.59%, respectively; P = .002).","['In total, 100 eyes from 50 patients were prospectively examined']",['Cap Thickness'],"['proportion of OBL areas', 'OBL of the anterior lenticule plane', 'Mean gray values of the OBL in the posterior lenticule plane', 'focal OBLs', 'OBL area and density']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",50.0,0.0498444,"For OBL areas located in the posterior lenticule plane, mean areas for the 110-µm group were also higher than those for the 140-µm group (1.32% ± 1.20% and 0.94% ± 0.59%, respectively; P = .002).","[{'ForeName': 'De', 'Initials': '', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': ''}]","Journal of refractive surgery (Thorofare, N.J. : 1995)",['10.3928/1081597X-20200720-02']
2310,32901950,Shorter RSPV cryoapplications result in less phrenic nerve injury and similar 1-year freedom from atrial fibrillation.,"BACKGROUND


In the 123-study we prospectively assessed, in a randomized fashion, the minimal cryoballoon application time necessary to achieve pulmonary vein (PV) isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) with the aim to reduce complications by shortening the application duration. The first results of this study demonstrated that shortened cryoballoon applications (< 2 minutes) resulted in less phrenic nerve injury (PNI) without compromising acute isolation efficacy for the right PVs. We now report the 1-year follow-up results regarding safety and efficacy of shorter cryoballoon applications.
METHODS


222 patients with AF were randomized to two applications of 1 min ""short"", 2 min ""medium""or 3 min ""long"" duration, 74 per group. Recurrence of AF and PV reconduction at 1-year follow-up were assessed.
RESULTS


The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07). randomization groups. In 30 patients a redo PVI procedure was performed. For all four PVs there was no significant difference in reconduction between the three groups. Reconduction was most common in the left superior PV (57%). The right superior PV (RSPV) showed significantly less reconduction (17%) compared to the other PVs.
CONCLUSIONS


Shortening cryoballoon applications of the RSPV to <2 minutes results in less PNI while acute success and 1-year freedom from AF is not compromised. Therefore shorter cryoballoon applications (especially) in the RSPV could be used to reduce PNI. This article is protected by copyright. All rights reserved.",2020,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","['222 patients with AF', 'patients with paroxysmal atrial fibrillation (AF']",['pulmonary vein (PV) isolation (PVI'],"['overall 1-year freedom from AF', 'reconduction', 'Recurrence of AF and PV reconduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}]",222.0,0.0304896,"The overall 1-year freedom from AF was 79% and did not differ significantly between the short, medium and long application groups (77, 74 and 85% for short, medium and long application groups, respectively; P = 0.07).","[{'ForeName': 'Marleen M D', 'Initials': 'MMD', 'LastName': 'Molenaar', 'Affiliation': 'Medisch Spectrum Twente, Koningsplein 1, Enschede, 7512 KZ, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hesselink', 'Affiliation': 'Medisch Spectrum Twente, Koningsplein 1, Enschede, 7512 KZ, The Netherlands.'}, {'ForeName': 'Rachel M A', 'Initials': 'RMA', 'LastName': 'Ter Bekke', 'Affiliation': 'Maastricht University Medical Centre, P. Debijelaan 25, Maastricht, 6229 HX, The Netherlands.'}, {'ForeName': 'Marcoen F', 'Initials': 'MF', 'LastName': 'Scholten', 'Affiliation': 'Medisch Spectrum Twente, Koningsplein 1, Enschede, 7512 KZ, The Netherlands.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Manusama', 'Affiliation': 'Maastricht University Medical Centre, P. Debijelaan 25, Maastricht, 6229 HX, The Netherlands.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pison', 'Affiliation': 'Ziekenhuis Oost-Limburg, Schiepse Bos 6, Genk, 3600, Belgium.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medisch Spectrum Twente, Koningsplein 1, Enschede, 7512 KZ, The Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kraaier', 'Affiliation': 'Medisch Centrum Leeuwarden Henri Dunantweg 2, Leeuwarden, 8934 AD.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ten Haken', 'Affiliation': 'Universiteit Twente, Drienerlolaan 5, Enschede, 7522 NB, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Grandjean', 'Affiliation': 'Medisch Spectrum Twente, Koningsplein 1, Enschede, 7512 KZ, The Netherlands.'}, {'ForeName': 'Carl C', 'Initials': 'CC', 'LastName': 'Timmermans', 'Affiliation': 'Maastricht University Medical Centre, P. Debijelaan 25, Maastricht, 6229 HX, The Netherlands.'}, {'ForeName': 'Jurren M', 'Initials': 'JM', 'LastName': 'van Opstal', 'Affiliation': 'Medisch Spectrum Twente, Koningsplein 1, Enschede, 7512 KZ, The Netherlands.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.14062']
2311,32901972,Effects of listening to music in digestive endoscopy: A prospective intervention study led by nursing.,"AIMS


To explore whether music can reduce anxiety and pain in patients who underwent diagnostic endoscopic examinations in conscious and deep sedation and to assess degree of satisfaction and willingness to repeat the procedure.
DESIGN


Prospective study led by nursing.
METHODS


Between March 2019-June 2019, consecutive outpatients undergoing endoscopic examinations were simple matched into four groups: Group 1: conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music. Ten minutes before the procedure, two trainee nurses applied music. State-Trait Anxiety Inventory was used to evaluate anxiety.
RESULTS


Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure. Only within Group 1 median anxiety, measured after the procedure, is lower than that measured before. In the bivariate logistic regression model, pain and listening to music were independent factors for satisfaction and willingness to repeat procedure.
CONCLUSION


music in digestive endoscopy reduce pain and anxiety in conscious sedation, thus could be used to reduce anxiety in support to conscious sedation leading to lower usage of deep sedation and consequently reduction of costs and adverse events.
IMPACT


Anxiety in digestive endoscopy limits patients' satisfaction. Music in digestive endoscopy as a specific nursing intervention could reduce anxiety of patients. This nursing intervention study confirms positive effect of music in digestive endoscopy. As part of nursing management, the addition of music to daily care practice in digestive endoscopy may reduce anxiety and increase the patient's degree of satisfaction. Use of music could limit deep sedation use in digestive endoscopy with consequent reduction of risks for patients, execution times, and costs of procedures.",2020,"Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure.","[""digestive endoscopy limits patients' satisfaction"", 'digestive endoscopy', 'patients who underwent diagnostic endoscopic examinations in conscious and deep sedation', 'Between March 2019-June 2019, consecutive outpatients undergoing']","['listening to music', 'music in digestive endoscopy', 'endoscopic examinations', 'conscious sedation with music; Group 2: conscious sedation without music; Group 3: deep sedation with music and Group 4: deep sedation without music']","['pain and anxiety', 'level anxiety', 'pain intensity', 'anxiety and pain', 'median anxiety']","[{'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0079278', 'cui_str': 'Gastrointestinal tract endoscopy'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1956064', 'cui_str': 'Sedation, Deep'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.072793,"Before and at the end of the procedure, patients who listened to music had a lower level anxiety than those who did not listen and, also, reported lower pain intensity during procedure.","[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Spagnuolo', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Corea', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Mariantonietta', 'Initials': 'M', 'LastName': 'Blumetti', 'Affiliation': ""School of Nursing, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Giovinazzo', 'Affiliation': ""School of Nursing, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Serafino', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Pagliuso', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Pagnotta', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Curto', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cosco', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cosco', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Rosellina Margherita', 'Initials': 'RM', 'LastName': 'Mancina', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Garieri', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Papaleo', 'Affiliation': 'Maggiore Hospital, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Grande', 'Affiliation': 'Department of Abdominal Surgery, S. Rita Clinic, Vercelli, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Barilaro', 'Affiliation': ""University Medical Hopsital 'Mater Domini', Catanzaro, Italy.""}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': ""Department of Surgical and Medical Sciences, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': ""Department of Surgical and Medical Sciences, University 'Magna Graecia', Catanzaro, Italy.""}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Doldo', 'Affiliation': ""Department of Clinical and Experimental Medicine, University 'Magna Graecia', Catanzaro, Italy.""}]",Journal of advanced nursing,['10.1111/jan.14516']
2312,32901984,Internet-based support program on parenting outcomes for Chinese primiparous women: Study protocol for a randomized controlled trial.,"AIM


To evaluate the effects of internet-based support program for primiparous women in terms of improving the levels of maternal self-efficacy, social support, and satisfaction; and reducing their postpartum depression symptoms.
DESIGN


A single-blinded, multicentre, randomized, controlled, parallel-group pre-test and repeated post-test design.
METHODS


Based on the self-efficacy theory and the social exchange theory, the internet-based support program has five modules: (a) learning forum of parenting knowledge and skills; (b) communication forum; (c) ask-the-expert forum; (d) baby home forum; and (e) reminder forum. Primiparous women will be recruited in the obstetric wards of two university-affiliated hospitals in China. The participants (N = 258) will be randomly allocated to the intervention group that receive routine care and access to the internet-based support program and the control group that receive routine care during the 3 months postpartum. Maternal self-efficacy, social support, and postpartum depression symptoms will be measured at baseline, immediately after the intervention (post-test 1) and 3 months after the intervention (post-test 2). The study was funded in January 2018 and was ethically approved in May 2020.
DISCUSSION


If the internet-based support program has positive outcomes, it will contribute to the scientific and practical knowledge of nursing interventions to support primiparous women on parenting; and could become the routine health care for health professionals to enhance parenting ability and mental well-being of new mothers.
IMPACT


As the first RCT study on parenting outcomes using a rigorous research design and a theoretical framework in China, this research will contribute to evidence on the effectiveness of using internet platform to support women after childbirth. The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms. Chinese Clinical Trial Registry: ChiCTR2000033154.",2020,"The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms.","['Chinese primiparous women', 'Primiparous women will be recruited in the obstetric wards of two university-affiliated hospitals in China', 'participants (N\xa0=\xa0258', 'primiparous women', 'primiparous women on parenting']","['social exchange theory, the internet-based support program', 'internet-based support program', 'Internet-based support program', 'intervention group that receive routine care and access to the internet-based support program and the control group that receive routine care']","['maternal self-efficacy, social support, and satisfaction', 'Maternal self-efficacy, social support, and postpartum depression symptoms']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",258.0,0.062753,"The results could help to advance research about the use of internet-based intervention methods to improve women's maternal self-efficacy, social support, satisfaction, and to alleviate depression symptoms.","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qiyu', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Ziwen', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Health Science Centre, Shenzhen University, Shenzhen, Guangdong, China.'}]",Journal of advanced nursing,['10.1111/jan.14517']
2313,32901996,Prolonging the duration of cooling does not enhance recovery following a marathon.,"Runners commonly utilise cryotherapy as part of their recovery strategy. Cryotherapy has been ineffective in mitigating signs and symptoms of muscle damage following marathon running and is limited by its duration of application. Phase change material (PCM) packs can prolong the duration of cooling. This study aimed to test the efficacy of prolonging the duration of cooling using PCM on perceptual recovery, neuromuscular function, and blood markers following a marathon run. Thirty participants completed a marathon run and were randomised to receive three hours of 15°C PCM treatment covering the quadriceps or recover without an intervention (control). Quadriceps soreness, strength, counter-movement jump (CMJ) height, creatine kinase (CK), and high sensitivity c-reactive protein (hsCRP) were recorded at baseline, 24, 48 and 72 hours after the marathon. Following the marathon strength decreased in both groups (P<0.0001), with no difference between groups. Compared to baseline, strength was reduced 24 (P=0.004) and 48 hours after the marathon (P=0.008) in the control group, but only 24 hours (P=0.028) in the PCM group. Soreness increased (P<0.0001) and CMJ height decreased (P<0.0001) in both groups, with no difference between groups. Compared to baseline, CMJ height was not reduced on any days in the PCM group but was reduced in the control group 24 (P<0.0001) and 48 hours (P=0.003) after the marathon. CK and hsCRP increased in both groups (P<0.0001). Although the marathon run induced significant muscle damage, prolonging the duration of cooling using PCM did not accelerate the resolution of any dependent variables.",2020,"Soreness increased (P<0.0001) and CMJ height decreased (P<0.0001) in both groups, with no difference between groups.",['Thirty participants completed a marathon run'],"['15°C PCM treatment covering the quadriceps or recover without an intervention (control', 'Cryotherapy']","['marathon strength', 'CK and hsCRP', 'Soreness', 'Quadriceps soreness, strength, counter-movement jump (CMJ) height, creatine kinase (CK), and high sensitivity c-reactive protein (hsCRP', 'perceptual recovery, neuromuscular function, and blood markers', 'CMJ height']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",30.0,0.045918,"Soreness increased (P<0.0001) and CMJ height decreased (P<0.0001) in both groups, with no difference between groups.","[{'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Kwiecien', 'Affiliation': 'Nicholas Institute of Sports Medicine and Athletic Trauma, Lenox Hill Hospital, New York, NY, USA.'}, {'ForeName': 'Malachy P', 'Initials': 'MP', 'LastName': 'McHugh', 'Affiliation': 'Nicholas Institute of Sports Medicine and Athletic Trauma, Lenox Hill Hospital, New York, NY, USA.'}, {'ForeName': 'Kirsty M', 'Initials': 'KM', 'LastName': 'Hicks', 'Affiliation': 'Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Keane', 'Affiliation': 'Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13822']
2314,32902075,Effect of enamel matrix derivative on alveolar ridge preservation in the posterior maxilla: A randomized controlled clinical trial.,"BACKGROUND


EMD has been considered to exert positive effects on wound healing, postoperative discomfort, and bone regeneration.
PURPOSE


The aim of this randomized controlled clinical trial was to investigate and compare (a) horizontal and vertical bone dimensional changes, (b) early postoperative discomfort and soft tissue wound healing outcomes, and (c) treatment modalities for implant placement, following posterior maxillary alveolar ridge preservation (ARP) with and without adjunctive use of EMD.
METHODS


Twenty-eight participants were randomly assigned to three groups: extraction sockets filled with bovine bone mineral and membrane with EMD (test group 1, n = 10) and without EMD (test group 2, n = 10) and spontaneous healing (control group, n = 8). Alveolar bone dimensional changes were measured using cone-beam computed tomography 5 months after ARP, and postoperative pain and wound healing outcomes were also evaluated.
RESULTS


There were no significant differences in horizontal or vertical bone dimensional changes between test groups 1 (horizontal width changes at 1 mm apically below the alveolar ridge crest [HW]: -1.44 ± 0.54 mm) and 2 (HW: -1.42 ± 0.26 mm), but the changes at HW (-2.36 ± 1.03 mm) in the control group were significantly greater than those in test groups 1 and 2 (P < .05). Early postoperative discomfort and soft tissue wound healing outcomes were not significantly different between the two test groups. Furthermore, unlike the control group, both the test groups 1 and 2 were implanted without sinus floor elevation using the lateral approach.
CONCLUSION


Within the limitations of this study, EMD failed to provide additional benefits in ARP in the posterior maxilla.",2020,There were no significant differences in horizontal or vertical bone dimensional changes between test groups 1 (horizontal width changes at 1 mm apically below the alveolar ridge crest [HW]: -1.44 ± 0.54 mm) and 2 (HW:,"['Twenty-eight participants', 'posterior maxilla']","['enamel matrix derivative', 'extraction sockets filled with bovine bone mineral and membrane with EMD (test group 1, n = 10) and without EMD', 'posterior maxillary alveolar ridge preservation (ARP']","['Alveolar bone dimensional changes', 'alveolar ridge preservation', 'horizontal or vertical bone dimensional changes', 'postoperative pain and wound healing outcomes', 'wound healing outcomes', 'Early postoperative discomfort and soft tissue']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0340861', 'cui_str': 'Electromechanical dissociation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0222744', 'cui_str': 'Structure of alveolar arch of maxilla'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}]",28.0,0.0852841,There were no significant differences in horizontal or vertical bone dimensional changes between test groups 1 (horizontal width changes at 1 mm apically below the alveolar ridge crest [HW]: -1.44 ± 0.54 mm) and 2 (HW:,"[{'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, South Korea.'}, {'ForeName': 'Seong-Nyum', 'Initials': 'SN', 'LastName': 'Jeong', 'Affiliation': 'Department of Periodontology, Daejeon Dental Hospital, Institute of Wonkwang Dental Research, Wonkwang University College of Dentistry, Daejeon, South Korea.'}]",Clinical implant dentistry and related research,['10.1111/cid.12940']
2315,32902105,Radiological and histological evaluation of horizontal ridge augmentation using corticocancellous freeze-dried bone allograft with and without autogenous bone: A randomized controlled clinical trial.,"PURPOSE


The purpose of this study was radiological and histological evaluation of horizontal ridge augmentation using corticocancellous freeze-dried bone allograft (FDBA) with and without autogenous bone (AB).
MATERIALS AND METHODS


The present research was conducted on 42 patients (27 females and 15 males) with insufficient width of edentulous ridge. The patients were randomly assigned into two groups, FDBA alone + collagen membrane (n = 21) and the combined FDBA and AB + collagen membrane (n = 21). The horizontal alveolar ridge dimensions were measured using cone-beam computerized tomography before and 6 months after alveolar ridge augmentation. At the time of insertion of implants, biopsy of new bone was taken from 11 patients in each group and was analyzed histologically. The obtained data were statistically analyzed with paired t test and two-sample t test. The registration number was IRCT201109165305N3.
RESULTS


The mean ± SD ridge width gain after 6 months at the distance of 0, 2, 4, and 6 mm from crest of alveolar ridge was 2.78 ± 1.44, 3.05 ± 1.21, 2.82 ± 1.62, and 2.23 ± 1.95 mm in the FDBA group and 2.40 ± 1.60, 3.10 ± 1.80, 3.60 ± 1.87, and 2.65 ± 2.39 mm in the combined group, respectively, which was statistically significant in both groups using paired t test (P < .001). However, the difference between two groups analyzed by two-sample t test was not statistically significant (P > .05). Amount of new bone generation, remained particles, and connective tissue was not statistically different between two groups (P = .367, P = .428, and P = .598, respectively).
CONCLUSION


Based on the results of this study, corticocancellous FDBA granules along with collagen membrane can successfully be used for horizontal augmentation of edentulous ridge, and adding AB to the granules of FDBA does not significantly increase the quality and quantity of regenerated bone.",2020,"Amount of new bone generation, remained particles, and connective tissue was not statistically different between two groups (P = .367, P = .428, and P = .598, respectively).
",['42 patients (27 females and 15 males) with insufficient width of edentulous ridge'],"['combined FDBA and AB + collagen membrane', 'FDBA alone + collagen membrane', 'horizontal ridge augmentation using corticocancellous freeze-dried bone allograft (FDBA) with and without autogenous bone (AB', 'horizontal ridge augmentation using corticocancellous freeze-dried bone allograft with and without autogenous bone']","['mean\u2009±\u2009SD ridge width gain', 'horizontal alveolar ridge dimensions', 'quality and quantity of regenerated bone']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}]",42.0,0.0930983,"Amount of new bone generation, remained particles, and connective tissue was not statistically different between two groups (P = .367, P = .428, and P = .598, respectively).
","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Hashemipoor', 'Affiliation': 'Department of Periodontics, Kashan Dental School, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Najmeh', 'Initials': 'N', 'LastName': 'Asghari', 'Affiliation': 'Henry M. Goldman School of Dental Medicine, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Kalantari', 'Affiliation': 'Department of Oral and Maxillofacial Pathology, and Oral and Dental Diseases Research Center, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohaddese', 'Initials': 'M', 'LastName': 'Arabsolghar', 'Affiliation': 'Oral and Dental Diseases Research Center and Department of Periodontics, Kerman Dental School, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Ranjbar', 'Affiliation': 'Mental Health Research Center, Psychosocial Health Research Institute, Iran University of Medical Sciences, Tehran, Iran.'}]",Clinical implant dentistry and related research,['10.1111/cid.12935']
2316,32902132,Romiplostim treatment for children with immune thrombocytopenia: Results of an integrated database of five clinical trials.,"BACKGROUND


Treatment for chronic immune thrombocytopenia (cITP) in children is largely limited to immunosuppressive agents. Thrombopoietin receptor agonists (TRAs) have been used to treat cITP in adults for over a decade. The objective of this integrated analysis was to examine the safety and efficacy of the TRA romiplostim in children with ITP.
METHODS


We examined efficacy and safety in children with ITP across five romiplostim trials: final data from two double-blind placebo-controlled trials and two open-label extensions, and interim data from an ongoing single-arm trial.
RESULTS


Patients (n = 24 initially placebo; n = 262 initially romiplostim) had a median age of 10.0 years (Q1: 6.0, Q3: 13.0), ITP duration of 1.9 years (Q1: 1.0, Q3: 4.0), and baseline platelet count of 14.3 × 10 9  /L (Q1: 7.5, Q3: 23.0). Among 282 patients receiving romiplostim, median treatment duration was 65 weeks (range 8-471 weeks) and median weekly dose was 6.6 μg/kg (range 0.1-9.7 μg/kg). Overall, 89% of romiplostim-treated patients had platelet responses. Nineteen patients (7%) maintained treatment-free responses for ≥6 months while withholding all ITP therapy. Grade 3 and 4 adverse events of bleeding occurred in 10% and <1% of romiplostim-treated patients, respectively. Twenty-five percent of patients had a serious adverse event, most commonly epistaxis (6%). Seven patients (2%) had neutralizing antibodies against romiplostim postbaseline and none had neutralizing antibodies against endogenous thrombopoietin. Efficacy and safety results appeared similar between children with ITP for ≤12 months and >12 months at baseline.
CONCLUSIONS


Across five pediatric clinical trials, romiplostim was well tolerated. Most patients had a platelet response; some maintained responses for at least 6 months while withholding all ITP therapy.",2020,Seven patients (2%) had neutralizing antibodies against romiplostim postbaseline and none had neutralizing antibodies against endogenous thrombopoietin.,"['children with ITP for ≤12\xa0months and >12\xa0months at baseline', 'children with immune thrombocytopenia', 'children with ITP across five romiplostim trials', '262 initially romiplostim) had a median age of 10.0\xa0years (Q1: 6.0, Q3: 13.0), ITP duration of 1.9\xa0years (Q1: 1.0, Q3: 4.0), and baseline platelet count of 14.3', 'n\xa0', 'Patients (n\xa0', 'children with ITP', '282 patients receiving romiplostim, median treatment duration was 65\xa0weeks (range 8-471\xa0weeks) and median weekly dose was 6.6\xa0μg/kg (range 0.1-9.7\xa0μg/kg']","['Thrombopoietin receptor agonists (TRAs', 'placebo', 'Romiplostim treatment']","['neutralizing antibodies against romiplostim postbaseline', 'Grade 3 and 4 adverse events of bleeding', 'efficacy and safety', 'safety and efficacy', 'neutralizing antibodies against endogenous thrombopoietin', 'Efficacy and safety', 'tolerated', 'serious adverse event', 'platelet responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021540', 'cui_str': 'Inosine triphosphate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C4517420', 'cui_str': '0.1'}]","[{'cui': 'C2584967', 'cui_str': 'Thrombopoietin receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}]",262.0,0.399601,Seven patients (2%) had neutralizing antibodies against romiplostim postbaseline and none had neutralizing antibodies against endogenous thrombopoietin.,"[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Tarantino', 'Affiliation': 'The Bleeding and Clotting Disorders Institute and University of Illinois College of Medicine at Peoria, Peoria, Illinois.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Despotovic', 'Affiliation': ""Texas Children's Hematology Center, Houston, Texas.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roy', 'Affiliation': ""Children's Health Queensland & Pathology Queensland, The University of Queensland, Saint Lucia, Brisbane, Queensland, Australia.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grainger', 'Affiliation': ""Royal Manchester Children's Hospital, University of Manchester, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Cooper', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, UK.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Beam', 'Affiliation': ""Cook Children's Medical Center, Fort Worth, Texas.""}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'Pediatric Cancer and Blood Disorders Clinic, Louisville, Kentucky.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Maschan', 'Affiliation': 'Dmitry Rogachev National Research Center for Pediatric Hematology, Oncology and Immunology, Moscow, Russia.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Eisen', 'Affiliation': 'Amgen Inc., Thousand Oaks, California.'}]",Pediatric blood & cancer,['10.1002/pbc.28630']
2317,32902207,A 12-week exercise program improves functional status in post-menopausal osteoporotic women: randomized controlled study.,"BACKGROUND


Beside the importance of implementing physical activity in treatment of patients with osteoporosis, the multicomponent exercise program and assessment of its functional outcomes performed by five performance-based measures, have not been explored yet.
AIM


The present study evaluated the effect of the 12 weeks exercise program on functional outcomes of postmenopausal patients with densitometric diagnosed osteoporosis.
DESIGN


The study was designed as randomised control study.
SETTING


Female outpatients with diagnosed postmenopausal osteoporosis were included in the study.
POPULATION


Women from urban area were presented.
METHODS


Patients were randomized in two groups: ""exercise group"" (EG) and ""control group"" (CG). Patients in the exercise group (n=47) participated in a 12 weeks exercise program, which consisted of resistance training, balance exercise and aerobic exercise, while patients from control group (n=49) had not participated in any exercise program during the intervention period. Functional outcomes determined by ""Time Up and Go"" test (TUG), ""Sit To Stand"" test (STS) and ""One Leg Stance Test"" (OLST) were evaluated at baseline and 4 and 12 weeks after treatment, while ""Fall Efficacy Scale"" (FES-I) and ""knowledge about osteoporosis questionnaire"" (OKAT-S) were assessed at baseline andafter 12 weeks, respectively.
RESULTS


There were noticed statistically significant improvement in all observed measurements in EG after 4 and 12 weeks, respectively. Comparison between groups showed statistically significant difference in EG compared to CG in all functional outcomes in observed periods (p<0.001 for all). OLST significantly changed only in EG, not in CG, in both experimental periods. After 4 weeks, in CG there were no statistically significant changes in any of the monitored parameters, while after 12 weeks improvements were detected with TUG, STS, FES-I and OKAT-S.
CONCLUSIONS


12 weeks exercise program, as an effective, inexpensive and easily performed method, improved functional status in postmenopausal osteoporotic women.
CLINICAL REHABILITATION IMPACT


In the present study we found that supervised exercise program in postmenopausal osteoporotic female patients significantly improved their muscle strength and balance and decrease fear of falling. Thus, it is proposed to be a part of clinical protocol for osteoporosis treatment.",2020,Comparison between groups showed statistically significant difference in EG compared to CG in all functional outcomes in observed periods (p<0.001 for all).,"['Patients', 'patients with osteoporosis', 'Female outpatients with diagnosed postmenopausal osteoporosis were included in the study', 'postmenopausal osteoporotic female patients', 'post-menopausal osteoporotic women', 'postmenopausal patients with densitometric diagnosed osteoporosis', 'Patients in the exercise group (n=47) participated in a 12 weeks', 'postmenopausal osteoporotic women', 'Women from urban area were presented']","['OLST', 'exercise program, which consisted of resistance training, balance exercise and aerobic exercise, while patients from control group (n=49) had not participated in any exercise program', 'supervised exercise program', 'exercise group"" (EG) and ""control group"" (CG', 'exercise program']","['functional status', 'Time Up and Go"" test (TUG), ""Sit To Stand"" test (STS) and ""One Leg Stance Test"" (OLST', 'Fall Efficacy Scale"" (FES-I) and ""knowledge about osteoporosis questionnaire"" (OKAT-S', 'muscle strength and balance and decrease fear of falling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",,0.0206797,Comparison between groups showed statistically significant difference in EG compared to CG in all functional outcomes in observed periods (p<0.001 for all).,"[{'ForeName': 'Tamara N', 'Initials': 'TN', 'LastName': 'Filipović', 'Affiliation': 'Institute for Rehabilitation, School of Medicine, University of Belgrade, Belgrade, Serbia - tamarabackovic@gmail.com.'}, {'ForeName': 'Milica P', 'Initials': 'MP', 'LastName': 'Lazović', 'Affiliation': 'Institute for Rehabilitation, School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Ana N', 'Initials': 'AN', 'LastName': 'Backović', 'Affiliation': 'Turval Laboratories Srl, Udine, Italy.'}, {'ForeName': 'Aleksandar N', 'Initials': 'AN', 'LastName': 'Filipović', 'Affiliation': 'Center for Radiology and MR, Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Aleksandra M', 'Initials': 'AM', 'LastName': 'Ignjatović', 'Affiliation': 'Department of Medical Statistics and Informatics, Faculty of Medicine, University of Niš, Niš, Serbia.'}, {'ForeName': 'Sanja S', 'Initials': 'SS', 'LastName': 'Dimitrijević', 'Affiliation': 'Special Hospital for Cerebral Palsy and Developmental Neurology, School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Kristina R', 'Initials': 'KR', 'LastName': 'Gopčević', 'Affiliation': 'Institute for Chemistry in Medicine, School of Medicine, University of Belgrade, Belgrade, Serbia.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.20.06149-3']
2318,32902312,Phase III study of nivolumab alone or combined with ipilimumab as immunotherapy versus standard of care in resectable head and neck squamous cell carcinoma.,"Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often requires postoperative chemoradiation with high risk of toxicity. Disease-free survival (DFS) after 2 years is approximately 70%. Combining nivolumab (N), a PD-1-inhibitor and ipilimumab (I), a CTLA4- inhibitor, may improve DFS due to antitumor effects of immunotherapy. The IMSTAR-HN study compares neoadjuvant N and N ± I 6 months after adjuvant therapy versus standard therapy as first-line treatment for LA-HNSCC. Eligible patients have treatment-naive LA-HNSCC, Eastern cooperative oncology group performance score (PS) ≤1 and no distant metastasis. 276 patients will be randomized into two arms. Primary end point is DFS and secondary end point includes locoregional control (LRC) and overall survival (OS). This study is one of the first in HNSCCs implementing immunotherapy in first-line treatment in a curative setting. Clinical Trial Registration: NCT03700905 (ClinicalTrials.gov).",2020,Disease-free survival (DFS) after 2 years is approximately 70%.,"['Locally advanced head and neck squamous cell carcinoma (LA-HNSCC', 'resectable head and neck squamous cell carcinoma', '276 patients', 'Eligible patients have treatment-naive LA-HNSCC, Eastern cooperative oncology group performance score (PS']","['nivolumab alone or combined with ipilimumab', 'Combining nivolumab (N), a PD-1-inhibitor\xa0and ipilimumab (I), a CTLA4- inhibitor']","['DFS and secondary end\xa0point includes locoregional control (LRC)\xa0and overall survival (OS', 'Disease-free survival (DFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C4086713', 'cui_str': 'Programmed cell death protein 1 inhibitor'}, {'cui': 'C2350360', 'cui_str': 'CTLA4 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",276.0,0.0531817,Disease-free survival (DFS) after 2 years is approximately 70%.,"[{'ForeName': 'Henrike B', 'Initials': 'HB', 'LastName': 'Zech', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Moeckelmann', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Boettcher', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Muenscher', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Mascha', 'Initials': 'M', 'LastName': 'Binder', 'Affiliation': 'Department of Internal Medicine IV, University Medical Center Halle (Saale), Germany.'}, {'ForeName': 'Eik', 'Initials': 'E', 'LastName': 'Vettorazzi', 'Affiliation': 'Department of Medical Biometry & Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Medical Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Betz', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Chia-Jung', 'Initials': 'CJ', 'LastName': 'Busch', 'Affiliation': 'Department of Otorhinolaryngology & Head & Neck Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]","Future oncology (London, England)",['10.2217/fon-2020-0595']
2319,32902313,"Satisfaction, utilization, and feasibility of a telehealth intervention for in-home dementia care support: A mixed methods study.","BACKGROUND


Technology can enhance support for families caring for persons living with dementia but must be acceptable to be adopted. The FamTechCare clinical trial engaged caregivers in video recording care encounters that were reviewed by an expert panel who provided tailored feedback. The intervention reduced caregiver depression and improved caregiver competence. This mixed methods study reports on caregiver satisfaction and utilization of the intervention and expert panel evaluation of the intervention.
METHODS


A convergent parallel mixed methods design was used to evaluate the satisfaction, usability, and feasibility of the FamTechCare intervention. In the multisite randomized controlled trial, caregiver-person living with dementia dyads were randomized to the FamTechCare video support or attention control telephone support groups. Caregivers completed a satisfaction survey at the completion of the 3-month trial. Utilization was evaluated using the number and duration of videos submitted and calls received by caregivers. Relationships between participant characteristics and their satisfaction and utilization were evaluated. Feasibility of the intervention was assessed through content analysis of interviews with the expert panel.
RESULTS


The majority of caregivers in both groups reported benefits from participation. More FamTechCare caregivers found the interventionist support to be helpful ( p  = 0.001) and effective ( p  = 0.020) compared to attention control caregivers. FamTechCare caregivers of persons with more severe dementia were more likely to report that video recording intruded on their privacy ( p  = 0.050). Caregiver age, gender, education, dyad relationship, rural status, and type and severity of dementia were not associated with ratings of acceptability, ease of use, or intervention utilization. The expert panel described the FamTechCare intervention as useful and identified adaptations to enhance feasibility.
CONCLUSION


Regardless of age, gender, and relationship, caregivers found the intervention acceptable and easy to use and rated the expert feedback as effective in addressing care challenges. Further adaptation may be needed for FamTechCare to be readily implemented.",2020,More FamTechCare caregivers found the interventionist support to be helpful ( p  = 0.001) and effective ( p  = 0.020) compared to attention control caregivers.,"['home dementia care support', 'families caring for persons living with dementia', 'caregiver-person living with dementia dyads', 'FamTechCare caregivers of persons with more severe dementia']","['FamTechCare intervention', 'FamTechCare video support or attention control telephone support groups']","['satisfaction, usability, and feasibility', 'Satisfaction, utilization, and feasibility of a telehealth intervention', 'caregiver depression and improved caregiver competence']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0518323,More FamTechCare caregivers found the interventionist support to be helpful ( p  = 0.001) and effective ( p  = 0.020) compared to attention control caregivers.,"[{'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, 21638University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'College of Nursing, 4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'College of Nursing, 4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'College of Nursing, 4083University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'School of Nursing, 21638University of Kansas, Kansas City, KS, USA.'}]","Dementia (London, England)",['10.1177/1471301220957905']
2320,32902321,The study of usefulness of low-dose IgG for patients with septic disseminated intravascular coagulation.,"Aim:  Improving prognosis with intravenous IgG (IVIG) has been ruled out in a large, multicenter, randomized controlled trial in patients with sepsis. However, its efficacy in the case of septic disseminated intravascular coagulation (DIC) has not been well studied.  Results & materials & methods:  We retrospectively evaluated the effects of IVIG on severity scores and 28-day survival in patients with septic DIC. A total of 80 patients with septic DIC were enrolled. Changes in infection-related markers, coagulation-related markers, severity scores and 28-day survival were compared between IVIG-treated and untreated groups.  Discussion/conclusion:  IVIG treatment significantly reduced the Sequential Organ Failure Assessment scores and DIC scores and increased platelet counts, but the 28-day mortality rate did not decrease significantly.",2020,"Changes in infection-related markers, coagulation-related markers, severity scores and 28-day survival were compared between IVIG-treated and untreated groups.  ","['patients with septic DIC', 'patients with sepsis', 'patients with septic disseminated intravascular coagulation', '80 patients with septic DIC were enrolled']","['intravenous IgG (IVIG', 'IVIG', 'low-dose IgG']","['28-day mortality rate', 'Sequential Organ Failure Assessment scores and DIC scores and increased platelet counts', 'severity scores and 28-day survival', 'Changes in infection-related markers, coagulation-related markers, severity scores\xa0and 28-day survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0857460', 'cui_str': 'Platelet count above reference range'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}]",80.0,0.227407,"Changes in infection-related markers, coagulation-related markers, severity scores and 28-day survival were compared between IVIG-treated and untreated groups.  ","[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Takahashi', 'Affiliation': 'Department of Critical Care & Disaster, General Medicine, Iwate Medical University, Iwate, Japan.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Critical Care & Disaster, General Medicine, Iwate Medical University, Iwate, Japan.'}]",Biomarkers in medicine,['10.2217/bmm-2020-0204']
2321,32902352,SYMMETRIC INTERLIMB TRANSFER OF NEWLY ACQUIRED SKILLED MOVEMENTS.,"In this study, we aimed to examine features of interlimb generalization or ""transfer"" of newly acquired motor skills with a broader goal of better understanding the mechanisms mediating skill learning. Right-handed participants (n=36) learned a motor task that required them to make very rapid but accurate reaches to 1 of 8 randomly presented targets, thus bettering the typical speed-accuracy tradeoff. Subjects were divided into an ""RL"" group that first trained with the right arm and was then tested on the left, and an ""LR"" group that trained with the left arm and was subsequently tested on the right. We found significant interlimb transfer in both groups. Remarkably, we also observed that participants learned faster with their left arm compared to the right. We hypothesized that this could be due to a previously suggested left arm-right hemisphere advantage for movements under variable task conditions. To corroborate this, we recruited two additional groups of participants (n=22) that practiced the same task under a single target condition. This removal of task level variability eliminated learning rate differences between the arms, yet, interlimb transfer remained robust and symmetric, as in the first experiment. Additionally, the approach adopted to reduce errors during learning, though heterogeneous across subjects particularly in our second experiment, was transferred to the untrained arm. These findings may be best explained as the outcome of the operation of cognitive strategies during the early stages of motor skill learning.",2020,"This removal of task level variability eliminated learning rate differences between the arms, yet, interlimb transfer remained robust and symmetric, as in the first experiment.",['two additional groups of participants (n=22) that practiced the same task under a single target condition'],"['RL', 'interlimb generalization or ""transfer"" of newly acquired motor skills']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",[],,0.0202815,"This removal of task level variability eliminated learning rate differences between the arms, yet, interlimb transfer remained robust and symmetric, as in the first experiment.","[{'ForeName': 'Goldy', 'Initials': 'G', 'LastName': 'Yadav', 'Affiliation': 'Centre for Cognitive Science, Indian Institute of Technology Gandhinagar, India.'}, {'ForeName': 'Pratik K', 'Initials': 'PK', 'LastName': 'Mutha', 'Affiliation': 'Biological Engineering and Center for Cognitive Science, Indian Institute of Technology Gandhinagar, India.'}]",Journal of neurophysiology,['10.1152/jn.00777.2019']
2322,32902375,Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT.,"BACKGROUND


Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery.
OBJECTIVES


The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome.
DESIGN


This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research.
SETTING


Urology departments of 26 NHS hospitals in England.
PARTICIPANTS


Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised.
INTERVENTIONS


Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm).
MAIN OUTCOME MEASURES


The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness.
RESULTS


A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS.
LIMITATIONS


The trial met its predefined recruitment target, but surgery rates were lower than anticipated.
CONCLUSIONS


Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS.
FUTURE WORK


Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN56164274.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.",2020,Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it.,"['Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures', 'men undergoing investigation of LUTS', 'Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised', '820 men were randomised (UDS, 427; routine care, 393', 'Urology departments of 26 NHS hospitals in England', 'bladder outlet obstruction in men', 'Men (aged ≥\u200918 years) seeking further treatment, potentially including surgery, for bothersome LUTS']","['LUTS', 'UDS', 'care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm']","['rates of surgery', 'acute urinary retention', 'surgery rate', 'International Prostate Symptom Score (IPSS', 'Severe bothersome', 'adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness', 'Quality-adjusted life-years (QALYs']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}, {'cui': 'C4075860', 'cui_str': 'Medically fit for surgery'}, {'cui': 'C0558080', 'cui_str': 'Unwilling'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0587531', 'cui_str': 'Urology department'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0005694', 'cui_str': 'Bladder neck obstruction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425722', 'cui_str': 'Sexual symptom'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",820.0,0.256808,Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it.,"[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Selman', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Caoimhe', 'Initials': 'C', 'LastName': 'Rice', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Clement', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Ochieng', 'Affiliation': 'Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Cathryn Ma', 'Initials': 'CM', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gordon T', 'Initials': 'GT', 'LastName': 'Taylor', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Bristol Urological Institute, Southmead Hospital, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24420']
2323,32902387,Quality of Care Perceived by Older Patients and Caregivers in Integrated Care Pathways With Interviewing Assistance From a Social Robot: Noninferiority Randomized Controlled Trial.,"BACKGROUND


Society is facing a global shortage of 17 million health care workers, along with increasing health care demands from a growing number of older adults. Social robots are being considered as solutions to part of this problem.
OBJECTIVE


Our objective is to evaluate the quality of care perceived by patients and caregivers for an integrated care pathway in an outpatient clinic using a social robot for patient-reported outcome measure (PROM) interviews versus the currently used professional interviews.
METHODS


A multicenter, two-parallel-group, nonblinded, randomized controlled trial was used to test for noninferiority of the quality of care delivered through robot-assisted care. The randomization was performed using a computer-generated table. The setting consisted of two outpatient clinics, and the study took place from July to December 2019. Of 419 patients who visited the participating outpatient clinics, 110 older patients met the criteria for recruitment. Inclusion criteria were the ability to speak and read Dutch and being assisted by a participating health care professional. Exclusion criteria were serious hearing or vision problems, serious cognitive problems, and paranoia or similar psychiatric problems. The intervention consisted of a social robot conducting a 36-item PROM. As the main outcome measure, the customized Consumer Quality Index (CQI) was used, as reported by patients and caregivers for the outpatient pathway of care.
RESULTS


In total, 75 intermediately frail older patients were included in the study, randomly assigned to the intervention and control groups, and processed: 36 female (48%) and 39 male (52%); mean age 77.4 years (SD 7.3), range 60-91 years. There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58. There was no significant difference in the total CQI scores between caregivers in the intervention group (mean 9.21, SD 0.76, n=30) and those in the control group (mean 9.09, SD 0.60, n=35): P=.47, 95% CI -0.21 to 0.46. No harm or unintended effects occurred.
CONCLUSIONS


Geriatric patients and their informal caregivers valued robot-assisted and nonrobot-assisted care pathways equally.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03857789; https://clinicaltrials.gov/ct2/show/NCT03857789.",2020,"There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58.","['17 million health care workers', '75 intermediately frail older patients were included in the study, randomly assigned to the intervention and control groups, and processed: 36 female (48%) and 39 male (52%); mean age 77.4 years (SD 7.3), range 60-91 years', '419 patients who visited the participating outpatient clinics, 110 older patients met the criteria for recruitment', 'Older Patients and Caregivers in Integrated Care Pathways']","['social robot conducting a 36-item PROM', 'Interviewing Assistance From a Social Robot', 'robot-assisted care']","['total patient CQI scores', 'total CQI scores', 'serious hearing or vision problems, serious cognitive problems, and paranoia or similar psychiatric problems', 'customized Consumer Quality Index (CQI']","[{'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",75.0,0.107016,"There was no significant difference in the total patient CQI scores between the patients included in the robot-assisted care pathway (mean 9.27, SD 0.65, n=37) and those in the control group (mean 9.00, SD 0.70, n=38): P=.08, 95% CI -0.04 to 0.58.","[{'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Boumans', 'Affiliation': 'Geriatric Department, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Fokke', 'Initials': 'F', 'LastName': 'van Meulen', 'Affiliation': 'Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'van Aalst', 'Affiliation': 'Geriatric Department, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Albers', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Marèse', 'Initials': 'M', 'LastName': 'Janssen', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Peters-Kop', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Getty', 'Initials': 'G', 'LastName': 'Huisman-de Waal', 'Affiliation': 'IQ healthcare, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'van de Poll', 'Affiliation': 'Geriatric Department, Canisius Wilhelmina Ziekenhuis, Nijmegen, Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Hindriks', 'Affiliation': 'Social AI Group, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Neerincx', 'Affiliation': 'Faculty of Electrical Engineering, Mathematics and Computer Science, Delft University of Technology, Delft, Netherlands.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Olde Rikkert', 'Affiliation': 'Geriatric Department, Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/18787']
2324,32902389,Validity and Usability of a Smartphone Image-Based Dietary Assessment App Compared to 3-Day Food Diaries in Assessing Dietary Intake Among Canadian Adults: Randomized Controlled Trial.,"BACKGROUND


Accurate dietary assessment is needed in studies that include analysis of nutritional intake. Image-based dietary assessment apps have gained in popularity for assessing diet, which may ease researcher and participant burden compared to traditional pen-to-paper methods. However, few studies report the validity of these apps for use in research. Keenoa is a smartphone image-based dietary assessment app that recognizes and identifies food items using artificial intelligence and permits real-time editing of food journals.
OBJECTIVE


This study aimed to assess the relative validity of an image-based dietary assessment app - Keenoa - against a 3-day food diary (3DFD) and to test its usability in a sample of healthy Canadian adults.
METHODS


We recruited 102 participants to complete two 3-day food records. For 2 weeks, on 2 non-consecutive days and 1 weekend day, in random order, participants completed a traditional pen-to-paper 3DFD and the Keenoa app. At the end of the study, participants completed the System Usability Scale. The nutrient analyses of the 3DFD and Keenoa data before (Keenoa-participant) and after they were reviewed by dietitians (Keenoa-dietitian) were analyzed using analysis of variance. Multiple tests, including the Pearson coefficient, cross-classification, kappa score, % difference, paired t test, and Bland-Altman test, were performed to analyze the validity of Keenoa (Keenoa-dietitian).
RESULTS


The study was completed by 72 subjects. Most variables were significantly different between Keenoa-participant and Keenoa-dietitian (P<.05) except for energy, protein, carbohydrates, fiber, vitamin B1, vitamin B12, vitamin C, vitamin D, and potassium. Significant differences in total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium were found between the 3DFD and Keenoa-dietitian data (P<.05). The Pearson correlation coefficients between the Keenoa-dietitian and 3DFD ranged from .04 to .51. Differences between the mean intakes assessed by the 3DFD and Keenoa-dietitian were within 10% except for vitamin D (misclassification rate=33.8%). The majority of nutrients were within an acceptable range of agreement in the Bland-Altman analysis; no agreements were seen for total energy, protein, carbohydrates, fat (%), saturated fatty acids, iron, potassium, and sodium (P<.05). According to the System Usability Scale, 34.2% of the participants preferred using Keenoa, while 9.6% preferred the 3DFD.
CONCLUSIONS


The Keenoa app provides acceptable relative validity for some nutrients compared to the 3DFD. However, the average intake of some nutrients, including energy, protein, carbohydrates, % fat, saturated fatty acids, and iron, differed from the average obtained using the 3DFD. These findings highlight the importance of verifying data entries of participants before proceeding with nutrient analysis. Overall, Keenoa showed better validity at the group level than the individual level, suggesting it can be used when focusing on the dietary intake of the general population. Further research is recommended with larger sample sizes and objective dietary assessment approaches.",2020,"Significant differences in total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium were found between the 3DFD and Keenoa-dietitian data (P<.05).","['102 participants to complete two 3-day food records', '72 subjects', 'healthy Canadian adults', 'Canadian Adults']","['traditional pen-to-paper 3DFD and the Keenoa app', 'Smartphone Image-Based Dietary Assessment', 'image-based dietary assessment app - Keenoa - against a 3-day food diary (3DFD']","['validity of Keenoa (Keenoa-dietitian', 'Dietary Intake', 'total energy, protein, carbohydrates, fat (%), saturated fatty acids, iron, potassium, and sodium (P<.05', 'total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium', '3DFD and Keenoa-dietitian', 'System Usability Scale', 'energy, protein, carbohydrates, fiber, vitamin B1, vitamin B12, vitamin C, vitamin D, and potassium']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012157', 'cui_str': 'Dietary Records'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",102.0,0.0531668,"Significant differences in total energy, protein, carbohydrates, % fat, saturated fatty acids, iron, and potassium were found between the 3DFD and Keenoa-dietitian data (P<.05).","[{'ForeName': 'Yuwei', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Plourde', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Bouzo', 'Affiliation': 'School of Human Nutrition, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Kilgour', 'Affiliation': 'Department of Health, Kinesiology, and Applied Physiology, Concordia University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara R', 'Initials': 'TR', 'LastName': 'Cohen', 'Affiliation': 'PERFORM Centre, Concordia University, Montreal, QC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/16953']
2325,32902390,"Age and Attitudes Towards an Internet-Mediated, Pedometer-Based Physical Activity Intervention for Chronic Obstructive Pulmonary Disease: Secondary Analysis.","BACKGROUND


Chronic obstructive pulmonary disease (COPD) is prevalent among older adults. Promoting physical activity and increasing exercise capacity are recommended for all individuals with COPD. Pulmonary rehabilitation is the standard of care to improve exercise capacity, although there are barriers that hinder accessibility. Technology has the potential to overcome some of these barriers, but it is unclear how aging adults with a chronic disease like COPD perceive technology-based platforms to support their disease self-management.
OBJECTIVE


Guided by the unified theory of acceptance and use of technology, the current retrospective secondary analysis explores if age moderates multiple factors that influence an individual with COPD's openness toward an internet-mediated, pedometer-based physical activity intervention.
METHODS


As part of an efficacy study, participants with COPD (N=59) were randomly assigned to use an internet-mediated, pedometer-based physical activity intervention for 12 weeks. At completion, they were asked about their experience with the intervention using a survey, including their performance expectancy and effort expectancy, facilitating conditions (ie, internet use frequency and ability), and use of the intervention technology. Logistic regression and general linear modeling examined the associations between age and these factors.
RESULTS


Participants ranged in age from 49 to 89 years (mean 68.66, SD 8.93). Disease severity was measured by forced expiratory volume in the first second percent predicted (mean 60.01, SD 20.86). Nearly all participants (54/59) believed the intervention was useful. Regarding effort expectancy, increasing age was associated with reporting that it was easy to find the time to engage in the intervention. Regarding facilitating conditions, approximately half of the participants believed the automated step count goals were too high (23/59) and many did not feel comfortable reaching their goals (22/59). The probability of these perceptions increased with age, even after accounting for disease severity. Age was not associated with other facilitating conditions or use of the technology.
CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention. Age is associated with certain expectations of effort and facilitating conditions. Consideration of age of the user is needed when personalizing step count goals and time needed to log in to the website.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01772082; https://clinicaltrials.gov/ct2/show/NCT01772082.",2020,"CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention.","['older adults', 'Chronic Obstructive Pulmonary Disease', 'Chronic obstructive pulmonary disease (COPD', 'Participants ranged in age from 49 to 89 years (mean 68.66, SD 8.93', 'individuals with COPD', 'participants with COPD (N=59']","['internet-mediated, pedometer-based physical activity intervention', 'Pedometer-Based Physical Activity Intervention']","['Age and Attitudes', 'forced expiratory volume', 'Disease severity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0549655,"CONCLUSIONS


Age does not influence performance expectancy or use of technology with an internet-mediated, pedometer-based physical activity intervention.","[{'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Robinson', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, United States.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Wan', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Veterans Affairs Boston Healthcare System, Boston, MA, United States.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Shimada', 'Affiliation': 'Center for Healthcare Organization and Implementation Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, United States.'}, {'ForeName': 'Caroline R', 'Initials': 'CR', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Marilyn L', 'Initials': 'ML', 'LastName': 'Moy', 'Affiliation': 'Pulmonary and Critical Care Medicine Section, Veterans Affairs Boston Healthcare System, Boston, MA, United States.'}]",JMIR aging,['10.2196/19527']
2326,32902391,Intervention Enhancement Strategies Among Adults With Type 2 Diabetes in a Very Low-Carbohydrate Web-Based Program: Evaluating the Impact With a Randomized Trial.,"BACKGROUND


Adults with type 2 diabetes may experience health benefits, including glycemic control and weight loss, from following a very low-carbohydrate, ketogenic (VLC) diet. However, it is unclear which ancillary strategies may enhance these effects.
OBJECTIVE


This pilot study aims to estimate the effect sizes of 3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring) that may improve outcomes of a 12-month web-based ad libitum VLC diet and lifestyle intervention for adults with type 2 diabetes. The primary intervention also included other components to improve adherence and well-being, including positive affect and mindfulness as well as coaching.
METHODS


Overweight or obese adults (n=44; BMI 25-45 kg/m 2 ) with type 2 diabetes (glycated hemoglobin [HbA 1c ] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention. Using a 2×2×2 randomized factorial design, we compared 3 enhancement strategies: (1) near-daily text messages about the intervention's recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring (urine n=21 vs breath n=23). We assessed HbA 1c  and weight at baseline and at 4, 8, and 12 months. We evaluated whether each strategy exerted a differential impact on HbA 1c  and weight at 12 months against an a priori threshold of Cohen d of 0.5 or greater.
RESULTS


We retained 73% (32/44) of the participants at 12 months. The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up. In intent-to-treat (ITT) analyses, the mean HbA 1c  reduction was 1.0% (SD 1.6) and the mean weight reduction was 5.3% (SD 6.0), whereas among study completers, these reductions were 1.2% (SD 1.7) and 6.3% (SD 6.4), respectively, all with a P value of less than .001. In ITT analyses, no enhancement strategy met the effect size threshold. Considering only study completers, 2 strategies showed a differential effect size of at least a d value of 0.5 or greater.
CONCLUSIONS


Text messages, gifts of food and cookbooks, and urine-based ketone self-monitoring may potentially enhance the glycemic or weight loss benefits of a web-based VLC diet and lifestyle intervention for individuals with type 2 diabetes. Future research could investigate other enhancement strategies to help create even more effective solutions for the treatment of type 2 diabetes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02676648; http://clinicaltrials.gov/ct2/show/NCT02676648.",2020,"The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up.","['Adults With Type', 'individuals with type 2 diabetes', 'Adults with type 2 diabetes', 'Overweight or obese adults (n=44; BMI 25-45 kg/m 2 ) with type 2 diabetes (glycated hemoglobin [HbA 1c ] ≥6.5%), who had been prescribed either no glucose-lowering medications or metformin alone, participated in a 12-month web-based intervention', 'adults with type 2 diabetes']","[""enhancement strategies: (1) near-daily text messages about the intervention's recommended behaviors (texts n=22 vs no texts n=22), (2) mailed gifts of diet-relevant foods and cookbooks (6 rounds of mailed gifts n=21 vs no gifts n=23), and (3) urine- or breath-based ketone self-monitoring"", 'VLC diet and lifestyle intervention', '3 intervention enhancement strategies (text messages, gifts, and breath vs urine ketone self-monitoring', 'libitum VLC diet and lifestyle intervention']","['adherence and well-being, including positive affect and mindfulness as well as coaching', 'glucose control and reductions in body weight', 'mean weight reduction', 'mean HbA 1c  reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376294', 'cui_str': 'Cookbooks'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0162275', 'cui_str': 'Ketonuria'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.0757783,"The intervention, across all conditions, led to improvements in glucose control and reductions in body weight at the 12-month follow-up.","[{'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Saslow', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Judith Tedlie', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Northwestern Medicine, Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': 'Department of Health Education, San Francisco State University, San Francisco, CA, United States.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Liestenfeltz', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Missel', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Hovig', 'Initials': 'H', 'LastName': 'Bayandorian', 'Affiliation': ''}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Aikens', 'Affiliation': 'Department of Family Medicine, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Osher Center for Integrative Medicine, University of California San Francisco, San Francisco, CA, United States.'}]",JMIR diabetes,['10.2196/15835']
2327,32902561,"Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery.","BACKGROUND


In the Protective Ventilation in Cardiac Surgery (PROVECS) randomized, controlled trial, an open-lung ventilation strategy did not improve postoperative respiratory outcomes after on-pump cardiac surgery. In this prespecified subanalysis, the authors aimed to assess the regional distribution of ventilation and plasma biomarkers of lung epithelial and endothelial injury produced by that strategy.
METHODS


Perioperative open-lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass. Control ventilation strategy was a low-PEEP (2 cm H2O) low-tidal volume approach. Electrical impedance tomography was used serially throughout the perioperative period (n = 56) to compute the dorsal fraction of ventilation (defined as the ratio of dorsal tidal impedance variation to global tidal impedance variation). Lung injury was assessed serially using biomarkers of epithelial (soluble form of the receptor for advanced glycation end-products, sRAGE) and endothelial (angiopoietin-2) lung injury (n = 30).
RESULTS


Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery were studied. Induction of general anesthesia was associated with ventral redistribution of tidal volumes and higher dorsal fraction of ventilation in the open-lung than the control strategy (0.38 ± 0.07 vs. 0.30 ± 0.10; P = 0.004). No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999). Open-lung ventilation was associated with increased intraoperative plasma sRAGE (7,677 ± 3,097 pg/ml vs. 6,125 ± 1,400 pg/ml; P = 0.037) and had no effect on angiopoietin-2 (P > 0.999).
CONCLUSIONS


In cardiac surgery patients, open-lung ventilation provided larger dorsal lung ventilation early during surgery without a maintained benefit as compared with controls at the end of surgery and postoperative day 2 and was associated with higher intraoperative plasma concentration of sRAGE suggesting lung overdistension.
EDITOR’S PERSPECTIVE


",2020,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"['cardiac surgery patients', 'Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery']","['open-lung ventilation', 'lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass']","['postoperative respiratory outcomes', 'dorsal lung ventilation', 'dorsal fraction of ventilation', 'intraoperative plasma sRAGE', 'ventral redistribution of tidal volumes and higher dorsal fraction of ventilation']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0821825,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lagier', 'Affiliation': ''}, {'ForeName': 'Lionel J', 'Initials': 'LJ', 'LastName': 'Velly', 'Affiliation': ''}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guinard', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Guidon', 'Affiliation': ''}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Alessi', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003539']
2328,32902572,A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery.,"BACKGROUND


This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials.
METHODS


A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality.
RESULTS


In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
CONCLUSIONS


This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.
EDITOR’S PERSPECTIVE


",2020,"Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
","['adult patients undergoing elective or semiurgent complex cardiothoracic surgery', 'high-risk cardiothoracic bleeding patients', 'adult patients undergoing complex cardiothoracic surgery', 'Complex Cardiothoracic Surgery']","['cold-stored platelets', 'standard room temperature-stored platelets', 'Platelets Stored Cold']","['median chest drain output', 'clinical effect measured by chest drain output', 'Total blood usage, number of adverse events, length of stay in intensive care, and mortality', 'platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality', 'Platelet aggregation', 'cold storage time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.187777,"Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets.
","[{'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Strandenes', 'Affiliation': ''}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Sivertsen', 'Affiliation': ''}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Bjerkvig', 'Affiliation': ''}, {'ForeName': 'Theodor K', 'Initials': 'TK', 'LastName': 'Fosse', 'Affiliation': ''}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Cap', 'Affiliation': ''}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Del Junco', 'Affiliation': ''}, {'ForeName': 'Einar Klæboe', 'Initials': 'EK', 'LastName': 'Kristoffersen', 'Affiliation': ''}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Haaverstad', 'Affiliation': ''}, {'ForeName': 'Venny', 'Initials': 'V', 'LastName': 'Kvalheim', 'Affiliation': ''}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Braathen', 'Affiliation': ''}, {'ForeName': 'Turid Helen Felli', 'Initials': 'THF', 'LastName': 'Lunde', 'Affiliation': ''}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Hervig', 'Affiliation': ''}, {'ForeName': 'Karl Ove', 'Initials': 'KO', 'LastName': 'Hufthammer', 'Affiliation': ''}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Spinella', 'Affiliation': ''}, {'ForeName': 'Torunn Oveland', 'Initials': 'TO', 'LastName': 'Apelseth', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003550']
2329,32902644,Exercise training reduces inflammation of adipose tissue in the elderly: cross-sectional and randomized interventional trial.,"CONTEXT


Metabolic disturbances and a pro-inflammatory state associated with aging and obesity may be mitigated by physical activity or nutrition interventions.
OBJECTIVE


The aim of this study is to assess whether physical fitness/exercise training (ET) alleviates inflammation in adipose tissue (AT), particularly in combination with omega-3 supplementation, and whether changes in AT induced by ET can contribute to an improvement of insulin sensitivity (IS) and metabolic health in the elderly.
DESIGN, PARTICIPANTS, MAIN OUTCOME MEASURES


The effect of physical fitness was determined in cross-sectional comparison of Trained and Untrained older women (71±4 years, n=48); and in double-blind randomized intervention by 4 months of ET with or without omega-3 (Calanus oil) supplementation (n=55). Physical fitness was evaluated by Spiroergometry (maximum graded exercise test) and Senior Fitness Tests. IS was measured by hyperinsulinemic-euglycemic clamp. Samples of subcutaneous AT were used to analyze mRNA gene expression, cytokine secretion and immune cell populations.
RESULTS


Trained women had lower mRNA levels of inflammation and oxidative stress markers, lower relative content of CD36+ macrophages and higher relative content of γδT-cells in AT when compared to Untrained women. Similar effects were recapitulated in response to a 4-month ET intervention. Content of CD36+ cells, γδT-cells and mRNA expression of several inflammatory and oxidative-stress markers correlated to IS and cardiorespiratory fitness.
CONCLUSIONS


In older women, physical fitness is associated with less inflammation in AT. This may contribute to beneficial metabolic outcomes achieved by ET. When combined with ET, omega-3 supplementation had no additional beneficial effects on AT inflammatory characteristics.",2020,"RESULTS


Trained women had lower mRNA levels of inflammation and oxidative stress markers, lower relative content of CD36+ macrophages and higher relative content of γδT-cells in AT when compared to Untrained women.","['Trained and Untrained older women (71±4 years, n=48', 'adipose tissue in the elderly']","['physical fitness/exercise training (ET', 'ET with or without omega-3 (Calanus oil) supplementation', 'Exercise training', 'ET, omega-3 supplementation']","['Physical fitness', 'lower mRNA levels of inflammation and oxidative stress markers', 'Content of CD36+ cells, γδT-cells and mRNA expression of several inflammatory and oxidative-stress markers', 'physical fitness', 'insulin sensitivity (IS) and metabolic health']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0054954', 'cui_str': 'Lymphocyte antigen CD36'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0381537,"RESULTS


Trained women had lower mRNA levels of inflammation and oxidative stress markers, lower relative content of CD36+ macrophages and higher relative content of γδT-cells in AT when compared to Untrained women.","[{'ForeName': 'Terezie', 'Initials': 'T', 'LastName': 'Čížková', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Štěpán', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Klára', 'Initials': 'K', 'LastName': 'Daďová', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Ondrůjová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sontáková', 'Affiliation': 'Faculty of Physical Education and Sport, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Krauzová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Miloš', 'Initials': 'M', 'LastName': 'Matouš', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Koc', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gojda', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kračmerová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Vladimír', 'Initials': 'V', 'LastName': 'Štich', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Rossmeislová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Šiklová', 'Affiliation': 'Department of Pathophysiology, Centre for Research on Diabetes, Metabolism and Nutrition, Third Faculty of Medicine, Charles University, Prague, Czech Republic.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa630']
2330,32902647,Effect of Androgen Deprivation on Long-term Outcomes of Intermediate-Risk Prostate Cancer Stratified as Favorable or Unfavorable: A Secondary Analysis of the RTOG 9408 Randomized Clinical Trial.,,2020,,['Intermediate-Risk Prostate Cancer Stratified as Favorable or Unfavorable'],['Androgen Deprivation'],[],"[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]","[{'cui': 'C0002844', 'cui_str': 'Androgen'}]",[],,0.082725,,"[{'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Daskivich', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Tighiouart', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Luu', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Rodgers', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.15083']
2331,32902668,Objective and subjective comparison of submucosal and intravenous routes of single-dose preoperative dexamethasone for mandibular third molar surgery-a prospective randomized observer-blind study.,"PURPOSE


Adjuvant corticosteroid administration through local routes has gained popularity due to ease of technique, lesser morbidity and presumed advantage of achieving therapeutic dosage at the site. To evaluate this, present study has compared submucosal route with an intravenous route control using single-dose preoperative dexamethasone. The study investigated objective facial measurements, mouth opening and compared them with subjective scores on a visual analogue scale and quality of life (QOL) recovery questionnaire.
MATERIALS AND METHODS


This was a prospective, randomized, open-label study with blinded end-point assessment of submucosal and intravenous routes of single preoperative dexamethasone administration, in patients undergoing mandibular third molar surgery. Patients were randomly divided into two groups and received 8 mg DX as either submucosal or intravenous injection 5 min after administration of local anaesthesia. Data was collected at 2nd and 7th post-op intervals. Statistical analysis was done keeping a P value < 0.05 as significant.
RESULTS


Thirty patients were evaluated in the study. SM route behaved similarly to IV route in producing changes in facial measurements [P = 0.533], mouth opening [P = 0.533] and pain [VAS] scores [P = 0.533] at early and late intervals. Questionnaire subscale scores were not significantly different between groups, but total mean score was significant [P = 0.050] with a measure of variance 17.54 in group IV compared with 39.54 of group SM showing that subjectively, IV route brought better recovery.
CONCLUSION AND CLINICAL RELEVANCE


Submucosal route can be an effective less invasive, painless, straightforward alternative to systemic administration of corticosteroid for improving QOL recovery in mandibular third molar surgery.",2020,"Questionnaire subscale scores were not significantly different between groups, but total mean score was significant [P = 0.050] with a measure of variance 17.54 in group IV compared with 39.54 of group SM showing that subjectively, IV route brought better recovery.
","['patients undergoing mandibular third molar surgery', 'Thirty patients were evaluated in the study', 'mandibular third molar surgery']","['single-dose preoperative dexamethasone', 'dexamethasone', 'single preoperative dexamethasone', '8\xa0mg DX']","['pain [VAS] scores', 'visual analogue scale and quality of life (QOL) recovery questionnaire', 'Questionnaire subscale scores', 'facial measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",30.0,0.0715115,"Questionnaire subscale scores were not significantly different between groups, but total mean score was significant [P = 0.050] with a measure of variance 17.54 in group IV compared with 39.54 of group SM showing that subjectively, IV route brought better recovery.
","[{'ForeName': 'Namitha M', 'Initials': 'NM', 'LastName': 'Hiriyanna', 'Affiliation': 'Oral and Maxillofacial Surgery, JSS Dental College, JSS Academy of Higher Education and Research, Mysuru, 570015, India. namithamh@hotmail.com.'}, {'ForeName': 'Saikrishna', 'Initials': 'S', 'LastName': 'Degala', 'Affiliation': 'Oral and Maxillofacial Surgery, JSS Dental College, JSS Academy of Higher Education and Research, Mysuru, 570015, India.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00904-0']
2332,32902676,Effect of ejaculatory abstinence period on sperm DNA fragmentation and pregnancy outcome of intrauterine insemination cycles:  A prospective randomized study.,"PURPOSE


To evaluate the effect of the ejaculatory abstinence period on sperm DNA fragmentation and pregnancy rates in IUI cycles.
METHODS


One hundred and twenty couples with unexplained infertility were prospectively randomized into two groups on the second day of their cycle. In group A, patients had 1-day ejaculatory abstinence period; in group B patients had 3-day ejaculatory abstinence period. Each patient was stimulated with gonadotropins, and IUI was performed. The primary outcome measure was clinical pregnancy and sperm DNA fragmentation rate.
RESULTS


The pregnancy rate was 17.3% and 18.5% in group A and group B, respectively. No significant difference was found among the groups (p = 0.803). The sperm DNA fragmentation rate for group A (20.71 ± 11.01) and group B (23.78 ± 12.64) were almost similar (p = 0.187). The sperm DNA fragmentation rate was 24.89 ± 12.89 in pregnant couples and 21.71 ± 11.69 in non-pregnant couples (p = 0.288).
CONCLUSION


Even after a short abstinence period of 1 day, compared to the standard abstinence period of 3 days, pregnancy rates are similar among unexplained infertility couples undergoing ovarian stimulation and IUI.
CLINICALTRIALS


The study was registered at ClinicalTrials.gov with ID NCT04361292. Date of registration: 27 April 2020. The study was registered retrospectively.",2020,The sperm DNA fragmentation rate for group A (20.71 ± 11.01) and group B (23.78 ± 12.64) were almost similar (p = 0.187).,"['One hundred and twenty couples with unexplained infertility', 'intrauterine insemination cycles']",['ejaculatory abstinence period'],"['sperm DNA fragmentation and pregnancy outcome', 'sperm DNA fragmentation rate', '3-day ejaculatory abstinence period', 'sperm DNA fragmentation and pregnancy rates', 'clinical pregnancy and sperm DNA fragmentation rate', 'pregnancy rate']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0376669', 'cui_str': 'DNA Fragmentation'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",120.0,0.10179,The sperm DNA fragmentation rate for group A (20.71 ± 11.01) and group B (23.78 ± 12.64) were almost similar (p = 0.187).,"[{'ForeName': 'Cihan', 'Initials': 'C', 'LastName': 'Kabukçu', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pamukkale University, 20070, Denizli, Turkey. cihankabukcu@yahoo.com.'}, {'ForeName': 'Nazlı', 'Initials': 'N', 'LastName': 'Çil', 'Affiliation': 'Department of Histology and Embryology, School of Medicine, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Ümit', 'Initials': 'Ü', 'LastName': 'Çabuş', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pamukkale University, 20070, Denizli, Turkey.'}, {'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Alataş', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Pamukkale University, 20070, Denizli, Turkey.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05783-0']
2333,32902700,Impact of antiplatelet therapy on tissue prolapse at super acute phase after stenting: serial OCT study in acute coronary syndrome patients.,"Although drug-eluting stents have improved clinical outcomes, percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) remains a challenging procedure in terms of thrombus management. A new-generation P2Y12 receptor inhibitor, prasugrel, provides more rapid and potent antiplatelet action compared with clopidogrel. Prasugrel achieved significant reduction of ischemic events compared with clopidogrel in ACS. The aim of this optical coherence tomography (OCT) study was to evaluate temporal changes in tissue prolapse after stenting under different antiplatelet regimens (aspirin plus prasugrel or clopidogrel) in ACS patients. A total of 119 ACS patients were randomized to either prasugrel or clopidogrel at the time of PCI. OCT analysis was available in 119 patients at baseline (just after stenting), 77 patients at 2 weeks, and 62 patients at 4 months after stenting. Cross-sectional analysis for every 1 mm was performed at in-stent and adjacent reference segment. Tissue prolapse area was calculated by lumen area minus stent area within the stented segment. Baseline patient and procedural characteristics were not different between the prasugrel and clopidogrel groups. Tissue prolapse area was significantly lower in the prasugrel compared with the clopidogrel group after stenting (0.24 ± 0.23 vs. 0.36 ± 0.23 mm 2 , p = 0.003) and at 2 weeks (0.11 ± 0.13 vs. 0.19 ± 0.16 mm 2 , p = 0.005). However, there was no significant difference at 4 months. In conclusion, our study suggests prasugrel was effective in reducing tissue prolapse in the super acute phase in ACS patients compared with clopidogrel. However, the effect of tissue prolapse reduction was not different up to 4 months follow-up.",2020,"Tissue prolapse area was significantly lower in the prasugrel compared with the clopidogrel group after stenting (0.24 ± 0.23 vs. 0.36 ± 0.23 mm 2 , p = 0.003) and at 2 weeks (0.11 ± 0.13 vs. 0.19 ± 0.16 mm 2 , p = 0.005).","['ACS patients', '119 ACS patients', 'acute coronary syndrome (ACS', 'tissue prolapse after stenting under different antiplatelet regimens ', 'acute coronary syndrome patients']","['prasugrel or clopidogrel', 'antiplatelet therapy', 'percutaneous coronary intervention (PCI', 'aspirin plus prasugrel or clopidogrel', 'clopidogrel', 'optical coherence tomography (OCT', 'Prasugrel']","['ischemic events', 'tissue prolapse reduction', 'Tissue prolapse area', 'tissue prolapse']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",119.0,0.0420192,"Tissue prolapse area was significantly lower in the prasugrel compared with the clopidogrel group after stenting (0.24 ± 0.23 vs. 0.36 ± 0.23 mm 2 , p = 0.003) and at 2 weeks (0.11 ± 0.13 vs. 0.19 ± 0.16 mm 2 , p = 0.005).","[{'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Naito', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Nakano', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Waseda', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan. waseda-circ@umin.ac.jp.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Sakurai', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Saka', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Sawada', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Shigeko', 'Initials': 'S', 'LastName': 'Nagahiro', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Shimoda', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Department of Cardiology, Aichi Medical University, 1-1, Yazakokarimata, Nagakute, Aichi, 480-1195, Japan.'}]",Heart and vessels,['10.1007/s00380-020-01686-x']
2334,32902766,"Clinical comparison of a micro-hybride resin-based composite and resin modified glass ionomer in the treatment of cervical caries lesions: 36-month, split-mouth, randomized clinical trial.","PURPOSE


The aim of the study was to compare the 36-month clinical performances of a micro-hybride resin based composites (RBC) and a type II resin modified glass ionomer cement (RMGIC) in the treatment of cervical caries lesions.
METHODS


Thirty-three patients (23 females,  10 males) with at least two cervical caries lesions participated in this study. A total of 110 restorations were randomly placed, half using RBC (Spectrum TPH3, Dentsply Sirona) with respective adhesive system (Prime & Bond NT, Dentsply Sirona) the other half using the RMGIC (Riva Light Cure, SDI, Bayswater, Victoria, Australia). Restorations were assessed at baseline, and after 6, 12, 18, 24 and 36 months using modified USPHS criteria. The data were analyzed statistically (p < 0.05).
RESULTS


Recall rate was 90.91% at 36 months. Of the RBC lesions 84.3% (n = 43) and of the RMGIC restorations 92.2% (n = 47) were fully retained at 36 months. There was no significant difference between two materials in terms of retention and marginal adaptation (p > 0.05). No relation was found between caries activity, cavity dimensions and marginal adaptation (p > 0.05) but RMGIC restorations showed significantly more discoloration than RBC restorations after 36 months (p < 0.001).
CONCLUSIONS


Considering the middle-term outcomes, both materials showed clinically successful performance in the treatment of cervical caries lesions.",2020,"No relation was found between caries activity, cavity dimensions and marginal adaptation (p > 0.05) but RMGIC restorations showed significantly more discoloration than RBC restorations after 36 months (p < 0.001).
","['A total of 110 restorations', 'cervical caries lesions', 'Thirty-three patients (23 females, \xa010 males) with at least two cervical caries lesions participated in this study']","['micro-hybride resin\xa0based composites (RBC) and a type II resin modified glass ionomer cement (RMGIC', 'micro-hybride resin-based composite and resin modified glass ionomer']","['Recall rate', 'successful performance', 'retention and marginal adaptation', 'caries activity, cavity dimensions and marginal adaptation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0376411', 'cui_str': 'Cervical caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0061297', 'cui_str': 'glass ionomer'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",110.0,0.0355539,"No relation was found between caries activity, cavity dimensions and marginal adaptation (p > 0.05) but RMGIC restorations showed significantly more discoloration than RBC restorations after 36 months (p < 0.001).
","[{'ForeName': 'Uzay', 'Initials': 'U', 'LastName': 'Koc Vural', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Sıhhıye, Ankara, 06100, Turkey. uzay.koc@hacettepe.edu.tr.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Kerimova', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Arlin', 'Initials': 'A', 'LastName': 'Kiremitci', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Hacettepe University, Sıhhıye, Ankara, 06100, Turkey.'}]",Odontology,['10.1007/s10266-020-00550-8']
2335,32898435,"Power, Lesion Size Index and Oesophageal Temperature Alerts during Atrial Fibrillation Ablation: A Randomized Study.","Background  - Low radiofrequency (RF) powers are commonly used on the posterior wall of the left atrium (LA) for atrial fibrillation (AF) ablation to prevent esophageal damage. Compared with higher powers, they require longer ablation durations to achieve a target lesion size index (LSI). Esophageal heating during ablation is the result of a time-dependent process of conductive heating produced by nearby RF delivery. This randomized study was conducted to compare risk of esophageal heating and acute procedure success of different LSI-guided ablation protocols combining higher or lower RF power and different target LSI values.  Methods  - Eighty consecutive patients were prospectively enrolled and randomized to one of 4 combinations of RF power and target LSI for ablation on the LA posterior wall (20W/LSI 4, 20W/LSI 5, 40W/LSI 4 and 40W/LSI 5). The primary endpoint of the study was the occurrence and number of esophageal temperature alerts (ETAs) per patient during ablation. Acute indicators of procedure success were considered as secondary end-points. Long term follow-up data were also collected for all patients.  Results  - Esophageal temperature alerts (ETAs) occurred in a similar proportion of patients in all groups. Significantly shorter RF durations were required to achieve the target LSI in the 40W groups. Less than 50% of the RF lesions reached the target LSI of 5 when using 20W despite a longer RF duration. A lower rate of first-pass Pulmonary Vein Isolation and a higher rate of acute Pulmonary Vein Reconnection were recorded in the group 20W/LSI 5. A lower AF recurrence rate was observed in the 40W groups compared to the 20W groups at 29 months follow-up.  Conclusions  - When guided by LSI, posterior wall ablation with 40W is associated with a similar rate of ETAs and a lower AF recurrence rate at follow-up if compared to 20W. These data will provide a basis to plan future randomized trials.",2020,A lower rate of first-pass Pulmonary Vein Isolation and a higher rate of acute Pulmonary Vein Reconnection were recorded in the group 20W/LSI 5.,['Methods  - Eighty consecutive patients'],"['RF power and target LSI for ablation on the LA posterior wall (20W/LSI 4, 20W/LSI 5, 40W', 'LSI-guided ablation protocols', '  - Low radiofrequency (RF) powers']","['acute Pulmonary Vein Reconnection', 'AF recurrence rate', 'RF durations', 'Power, Lesion Size Index and Oesophageal Temperature Alerts during Atrial Fibrillation Ablation', 'occurrence and number of esophageal temperature alerts (ETAs) per patient during ablation']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",80.0,0.0762474,A lower rate of first-pass Pulmonary Vein Isolation and a higher rate of acute Pulmonary Vein Reconnection were recorded in the group 20W/LSI 5.,"[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Leo', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Michala', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Rajappan', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ginks', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Ross J', 'Initials': 'RJ', 'LastName': 'Hunter', 'Affiliation': 'Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bowers', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Kalla', 'Affiliation': 'Queen Elisabeth Hospital, Birmingham, United Kingdom.'}, {'ForeName': 'Yaver', 'Initials': 'Y', 'LastName': 'Bashir', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, United Kingdom.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008316']
2336,32719045,Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated cytokine storm syndrome: results of the CHIC study.,"OBJECTIVES


To prospectively investigate in patients with severe COVID-19-associated cytokine storm syndrome (CSS) whether an intensive course of glucocorticoids with or without tocilizumab accelerates clinical improvement, reduces mortality and prevents invasive mechanical ventilation, in comparison with a historic control group of patients who received supportive care only.
METHODS


From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100 mg/L; ferritin >900 µg/L; D-dimer >1500 µg/L), received high-dose intravenous methylprednisolone for 5 consecutive days (250 mg on day 1 followed by 80 mg on days 2-5). If the respiratory condition had not improved sufficiently (in 43%), the interleukin-6 receptor blocker tocilizumab (8 mg/kg body weight, single infusion) was added on or after day 2. Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age. The primary outcome was ≥2 stages of improvement on a 7-item WHO-endorsed scale for trials in patients with severe influenza pneumonia, or discharge from the hospital. Secondary outcomes were hospital mortality and mechanical ventilation.
RESULTS


At baseline all patients with COVID-19 in the treatment group (n=86) and control group (n=86) had symptoms of CSS and faced acute respiratory failure. Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65). Treatment effects remained constant in confounding and sensitivity analyses.
CONCLUSIONS


A strategy involving a course of high-dose methylprednisolone, followed by tocilizumab if needed, may accelerate respiratory recovery, lower hospital mortality and reduce the likelihood of invasive mechanical ventilation in COVID-19-associated CSS.",2020,"Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65).","['patients with severe COVID-19-associated cytokine storm syndrome (CSS', 'From 1 April 2020, patients with COVID-19-associated CSS, defined as rapid respiratory deterioration plus at least two out of three biomarkers with important elevations (C-reactive protein >100\u2009mg/L; ferritin >900\u2009µg/L; D-dimer >1500\u2009µg/L', 'comparison with a historic control group of patients who received supportive care only', 'Control patients with COVID-19-associated CSS (same definition) were retrospectively sampled from the pool of patients (n=350) admitted between 7 March and 31 March, and matched one to one to treated patients on sex and age', 'patients with COVID-19-associated cytokine storm syndrome']","['interleukin-6 receptor blocker tocilizumab', 'methylprednisolone', 'glucocorticoids with or without tocilizumab', 'tocilizumab']","['≥2 stages of improvement on a 7-item WHO-endorsed scale', 'severe influenza pneumonia, or discharge from the hospital', 'hospital mortality and mechanical ventilation', 'symptoms of CSS and faced acute respiratory failure', 'invasive mechanical ventilation', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0155870', 'cui_str': 'Pneumonia and influenza'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0919747', 'cui_str': 'Cytokine storm'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3.0,0.16573,"Treated patients had 79% higher likelihood on reaching the primary outcome (HR: 1.8; 95% CI 1.2 to 2.7) (7 days earlier), 65% less mortality (HR: 0.35; 95% CI 0.19 to 0.65) and 71% less invasive mechanical ventilation (HR: 0.29; 95% CI 0.14 to 0.65).","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Ramiro', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands sofiaramiro@gmail.com.'}, {'ForeName': 'Rémy L M', 'Initials': 'RLM', 'LastName': 'Mostard', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Magro-Checa', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Christel M P', 'Initials': 'CMP', 'LastName': 'van Dongen', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Dormans', 'Affiliation': 'Department of Intensive Care, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Buijs', 'Affiliation': 'Department of Internal Medicine, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Gronenschild', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Martijn D', 'Initials': 'MD', 'LastName': 'de Kruif', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Eric H J', 'Initials': 'EHJ', 'LastName': 'van Haren', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'van Kraaij', 'Affiliation': 'Department of Pulmonology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Mathie P G', 'Initials': 'MPG', 'LastName': 'Leers', 'Affiliation': 'Department of Clinical Chemistry and Hematology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Peeters', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Wong', 'Affiliation': 'Department of Clinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Rheumatology, Zuyderland Medical Center, Heerlen, Limburg, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218479']
2337,32807092,Microbial epidemiology and risk factors for relapse in gram-negative bacteria catheter-related bloodstream infection with a pilot prospective study in patients with catheter removal receiving short-duration of antibiotic therapy.,"BACKGROUND


Infectious Diseases Society of America (IDSA) guidelines suggest 7-14 days' duration of antibiotic treatment for uncomplicated Gram-negative bacteria (GNB) catheter-related bloodstream infection (CRBSI). The objectives of this study were to review microbial epidemiology, to determine rate and risk factors for relapse, and to compare clinical outcomes in patients receiving long- versus short-duration antibiotic therapy.
METHODS


A retrospective phase 1 study was conducted between January 2010 and October 2016 to review microbial epidemiology and to determine the incidence of and risk factors for relapse in patients with GNB CRBSI, according to the IDSA guidelines diagnostic criteria. In phase 2 of the study, patients without risk factors for relapse between November 2016 and October 2017 were prospectively recruited to receive antibiotic therapy for 7 days after catheter removal. Matched patients from the retrospective phase 1 study who had received antibiotic therapy for ≥14 days were selected as a phase 2 control group to compare outcomes.
RESULTS


In phase 1, three most common pathogens identified among 174 cases were Pseudomonas aeruginosa (22.0%), Klebsiella pneumoniae (16.7%), and Stenotrophomonas maltophilia (13.4%). Eighty-nine episodes of infection occurred while patients were receiving antibiotic therapy. Of 140 cases, the relapse rate was 6.4%. Catheter retention was the only risk factor strongly associated with relapse (odds ratio = 145.32; 95% confidence interval 12.66-1667.37, P < 0.001). In phase 2, 11 patients with catheter removal were prospectively recruited to receive short-duration therapy. The number of patients with relapse receiving long- or short-duration therapy was 1 (3%) and 0 (0%), respectively (P = 1.000).
CONCLUSIONS


For the management of patients with uncomplicated GNB CRBSI, empiric broad-spectrum antibiotic therapy with adequate coverage of P. aeruginosa should be chosen. Catheter removal should be performed to prevent relapse and shortening the duration of treatment could be considered.
TRIAL REGISTRATION


Thai Clinical Trial Registry: TCTR20190914001 . Retrospectively registered on 13 September 2019.",2020,"Catheter retention was the only risk factor strongly associated with relapse (odds ratio = 145.32; 95% confidence interval 12.66-1667.37, P < 0.001).","['patients receiving long- versus short-duration antibiotic therapy', 'patients with GNB CRBSI, according to the IDSA guidelines diagnostic criteria', '11 patients with catheter removal', 'patients with catheter removal receiving short-duration of antibiotic therapy', 'patients without risk factors for relapse between November 2016 and October 2017', 'January 2010 and October 2016', 'Matched patients from the retrospective phase 1 study who had received']",['antibiotic therapy'],"['infection', 'number of patients with relapse receiving long- or short-duration therapy', 'relapse rate', 'Catheter retention', 'Pseudomonas aeruginosa', 'Klebsiella pneumoniae']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}, {'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}]",,0.0559913,"Catheter retention was the only risk factor strongly associated with relapse (odds ratio = 145.32; 95% confidence interval 12.66-1667.37, P < 0.001).","[{'ForeName': 'Bhitta', 'Initials': 'B', 'LastName': 'Surapat', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Preecha', 'Initials': 'P', 'LastName': 'Montakantikul', 'Affiliation': 'Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kumthorn', 'Initials': 'K', 'LastName': 'Malathum', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasisopin', 'Initials': 'S', 'LastName': 'Kiertiburanakul', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pitak', 'Initials': 'P', 'LastName': 'Santanirand', 'Affiliation': 'Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Busba', 'Initials': 'B', 'LastName': 'Chindavijak', 'Affiliation': 'Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand. busba.chi@mahidol.ac.th.'}]",BMC infectious diseases,['10.1186/s12879-020-05312-z']
2338,32143062,The influence of object similarity on real object-based attention: The disassociation of perceptual and semantic similarity.,"Perceptual and semantic similarity have an impact on object-based attention for the geometric objects. However, no previous studies have disassociated perceptual properties from the semantic ones of real objects that combine perceptual and semantic properties. It is unclear whether the perceptual and semantic similarity of real objects jointly or independently guides attentional deployment. The aim of the present study was to explore the influence of object similarity on object-based attention by using a variant of the two-rectangle paradigm and disassociating the perceptual and semantic similarity of real objects. The results indicated that when the semantic of objects was similar, the object-based effect was larger for the perceptually dissimilar condition than for the perceptually similar condition, because of slower response to invalid different-object location in a dissimilar condition. Moreover, when the perception of objects was similar, the object-based effect was larger for the semantically dissimilar condition than for the semantically similar condition, due to slower response to invalid different-object location in a dissimilar condition. These results suggest that perceptual and semantic similarity can independently guide attentional allocation to real objects and the similarity may constrain the object-based attention in a way of grouping. The current study implies that the attentional prioritization hypothesis is more flexible and effective to explain the real object-based attention and also has some implication to advertising design.",2020,"The results indicated that when the semantic of objects was similar, the object-based effect was larger for the perceptually dissimilar condition than for the perceptually similar condition, because of slower response to invalid different-object location in a dissimilar condition.",[],[],[],[],[],[],,0.0294916,"The results indicated that when the semantic of objects was similar, the object-based effect was larger for the perceptually dissimilar condition than for the perceptually similar condition, because of slower response to invalid different-object location in a dissimilar condition.","[{'ForeName': 'Saisai', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ""School of Psychology, Shaanxi Normal University, Xi'an 710062, China; Shaanxi Provincial Key Laboratory of Behavior & Cognitive Neuroscience, Xi'an 710062, China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""School of Psychology, Shaanxi Normal University, Xi'an 710062, China; Shaanxi Provincial Key Laboratory of Behavior & Cognitive Neuroscience, Xi'an 710062, China.""}, {'ForeName': 'Fangxing', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': ""School of Psychology, Shaanxi Normal University, Xi'an 710062, China; Shaanxi Provincial Key Laboratory of Behavior & Cognitive Neuroscience, Xi'an 710062, China.""}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Psychology, Shaanxi Normal University, Xi'an 710062, China; Shaanxi Provincial Key Laboratory of Behavior & Cognitive Neuroscience, Xi'an 710062, China. Electronic address: wyonghui@snnu.edu.cn.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""School of Psychology, Shaanxi Normal University, Xi'an 710062, China; Shaanxi Provincial Key Laboratory of Behavior & Cognitive Neuroscience, Xi'an 710062, China. Electronic address: zhaojingjing_31@126.com.""}]",Acta psychologica,['10.1016/j.actpsy.2020.103046']
2339,32143063,Sequential modulation of across-task congruency in the serial reaction time task.,"While detrimental effects of dual-tasking on the acquisition and usage of sequence knowledge in the Serial Reaction Time Task (SRTT) have been attributed to the integration of regularly and randomly sequenced events, direct evidence for across-task integration has been scarce. In two experiments, we paired two spatial tasks: A visual-manual SRTT (serial reaction time task) of length 4 and a two-choice task with random order of stimuli. We reasoned that across-task integration might result in SRTT- and two-choice task events being stored and retrieved together. Therefore, RT might be influenced by current congruency as well as by whether it is repeated or altered from the congruency level encountered for this SRTT event in the last loop of the sequence. We observed such a modulation in two experiments, suggesting that across-task integration indeed takes place and that the detrimental effect of dual-tasking on sequence learning is, at least in parts, based on across-task integration.",2020,"While detrimental effects of dual-tasking on the acquisition and usage of sequence knowledge in the Serial Reaction Time Task (SRTT) have been attributed to the integration of regularly and randomly sequenced events, direct evidence for across-task integration has been scarce.",[],['visual-manual SRTT (serial reaction time task) of length 4 and a two-choice task with random order of stimuli'],[],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",[],,0.0215335,"While detrimental effects of dual-tasking on the acquisition and usage of sequence knowledge in the Serial Reaction Time Task (SRTT) have been attributed to the integration of regularly and randomly sequenced events, direct evidence for across-task integration has been scarce.","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'University of Hagen, Germany. Electronic address: fang.zhao@fernuni-hagen.de.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gaschler', 'Affiliation': 'University of Hagen, Germany.'}, {'ForeName': 'David Olaf', 'Initials': 'DO', 'LastName': 'Nöhring', 'Affiliation': 'University of Hagen, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Röttger', 'Affiliation': 'University of Bremen, Germany.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Haider', 'Affiliation': 'University of Cologne, Germany.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103043']
2340,32145463,Cognitive processing of spatial relations in Euclidean diagrams.,"The cognitive processing of spatial relations in Euclidean diagrams is central to the diagram-based geometric practice of Euclid's Elements. In this study, we investigate this processing through two dichotomies among spatial relations-metric vs topological and exact vs co-exact-introduced by Manders in his seminal epistemological analysis of Euclid's geometric practice. To this end, we carried out a two-part experiment where participants were asked to judge spatial relations in Euclidean diagrams in a visual half field task design. In the first part, we tested whether the processing of metric vs topological relations yielded the same hemispheric specialization as the processing of coordinate vs categorical relations. In the second part, we investigated the specific performance patterns for the processing of five pairs of exact/co-exact relations, where stimuli for the co-exact relations were divided into three categories depending on their distance from the exact case. Regarding the processing of metric vs topological relations, hemispheric differences were found for only a few of the stimuli used, which may indicate that other processing mechanisms might be at play. Regarding the processing of exact vs co-exact relations, results show that the level of agreement among participants in judging co-exact relations decreases with the distance from the exact case, and this for the five pairs of exact/co-exact relations tested. The philosophical implications of these empirical findings for the epistemological analysis of Euclid's diagram-based geometric practice are spelled out and discussed.",2020,"Regarding the processing of metric vs topological relations, hemispheric differences were found for only a few of the stimuli used, which may indicate that other processing mechanisms might be at play.",['Euclidean diagrams'],['spatial relations-metric vs topological and exact vs co-exact-introduced by Manders'],[],[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}]",[],5.0,0.0294673,"Regarding the processing of metric vs topological relations, hemispheric differences were found for only a few of the stimuli used, which may indicate that other processing mechanisms might be at play.","[{'ForeName': 'Yacin', 'Initials': 'Y', 'LastName': 'Hamami', 'Affiliation': 'Centre for Logic and Philosophy of Science, Vrije Universiteit Brussel, Brussels, Belgium. Electronic address: yacin.hamami@gmail.com.'}, {'ForeName': 'Milan N A', 'Initials': 'MNA', 'LastName': 'van der Kuil', 'Affiliation': 'Department Health, Medical and Neuropsychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mumma', 'Affiliation': 'Philosophy Department, California State University of San Bernardino, San Bernardino, CA, USA.'}, {'ForeName': 'Ineke J M', 'Initials': 'IJM', 'LastName': 'van der Ham', 'Affiliation': 'Department Health, Medical and Neuropsychology, Leiden University, Leiden, the Netherlands.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103019']
2341,32146318,The Simon effect in a discrete sequence production task: Key-specific stimuli cannot be ignored due to attentional capture.,"Two experiments examined whether practicing discrete key pressing sequences eventually leads to a disregard of the key-specific stimuli, as suggested by sequence learning models, or whether these stimuli continue to be relied upon because the associated luminance increase attracts visuospatial attention. Participants practiced two sequences by reacting to two fixed series of seven letter stimuli, each displayed at a location that did or did not correspond with the required response location. Stimulus use was indicated by a Simon effect in that key presses were slowed when stimulus and key locations did not correspond. Experiment 1 demonstrated that letter stimuli continued to be used as the Simon effect occurred with each sequence element, and this remained quite stable across practice and did not differ for familiar and unfamiliar sequences. Experiment 2 showed that the Simon effect remained present even with meaningless stimuli that were often even harmful. These findings suggest that even in motor sequences that can be executed without element-specific stimuli attention attraction enforces stimulus use. The data further supported the assumptions that S-R translation and sequencing systems are racing to trigger individual responses, and that explicit sequence representations include spatial and verbal knowledge.",2020,Stimulus use was indicated by a Simon effect in that key presses were slowed when stimulus and key locations did not correspond.,[],[],[],[],[],[],,0.0148982,Stimulus use was indicated by a Simon effect in that key presses were slowed when stimulus and key locations did not correspond.,"[{'ForeName': 'Willem B', 'Initials': 'WB', 'LastName': 'Verwey', 'Affiliation': 'Department of Cognitive Psychology and Ergonomics, University of Twente, Enschede, the Netherlands; Human Performance Laboratories, Department of Health and Kinesiology, Texas A&M University, College Station, TX, USA. Electronic address: w.b.verwey@utwente.nl.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Wright', 'Affiliation': 'Human Performance Laboratories, Department of Health and Kinesiology, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Rob H J', 'Initials': 'RHJ', 'LastName': 'Van der Lubbe', 'Affiliation': 'Department of Cognitive Psychology and Ergonomics, University of Twente, Enschede, the Netherlands; Laboratory of Vision Science and Optometry, Faculty of Physics, Adam Mickiewicz University, Poznań, Poland.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103044']
2342,32151791,Visual search inverts the classic Stroop asymmetry.,"The Stroop effect is typically much larger than the reverse Stroop effect. One explanation for this asymmetry asserts that interference between the attended feature and an incongruent unattended feature depends on which feature is more strongly associated with the processing typically needed to complete the task. Accordingly, because identification of the target's color or the target word (as in the traditional Stroop paradigm) is more strongly associated with verbal processing than visual processing, the target's meaning should interfere with identification of the target's color (Stroop) more than vice versa (reverse Stroop). In contrast, localization is more strongly associated with visual processing, so strength-of-association predicts that the target's color should interfere with localizing the target word (reverse Stroop) more than vice versa (Stroop). Experiments 1 and 2 supported the strength-of-association account: compared to Stroop, the reverse Stroop effect was smaller for an identification task, but larger for a localization task. Because overall responses were slower for the reverse Stroop condition than the Stroop condition in Experiment 2, we entertained two alternative explanations for the reverse Stroop effect being larger than the Stroop effect. Experiments 3 and 4 showed that the larger reverse Stroop effect could not have been due to scaling, and Experiment 5 showed that it could not have been due to covert translation. Taken together, these experiments demonstrate the role of strength of association in generating the classic Stroop asymmetry, and pave the way for future exploration of the reverse Stroop effect using localization tasks.",2020,"Experiments 1 and 2 supported the strength-of-association account: compared to Stroop, the reverse Stroop effect was smaller for an identification task, but larger for a localization task.",[],[],[],[],[],[],,0.0208423,"Experiments 1 and 2 supported the strength-of-association account: compared to Stroop, the reverse Stroop effect was smaller for an identification task, but larger for a localization task.","[{'ForeName': 'Kenith V', 'Initials': 'KV', 'LastName': 'Sobel', 'Affiliation': 'Department of Psychology and Counseling, University of Central Arkansas, United States of America. Electronic address: ksobel@uca.edu.'}, {'ForeName': 'Amrita M', 'Initials': 'AM', 'LastName': 'Puri', 'Affiliation': 'Department of Biology, University of Central Arkansas, USA.'}, {'ForeName': 'A Kane', 'Initials': 'AK', 'LastName': 'York', 'Affiliation': 'Neuroscience Graduate Program, University of Michigan, USA.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103054']
2343,32151792,Anisotropy of perceived numerosity: Evidence for a horizontal-vertical numerosity illusion.,"Many studies have investigated whether numerical and spatial abilities share similar cognitive systems. A novel approach to this issue consists of investigating whether the same perceptual biases underlying size illusions can be identified in numerical estimation tasks. In this study, we required adult participants to estimate the number of white dots in arrays made of white and black dots displayed in such a way as to generate horizontal-vertical illusions with inverted T and L configurations. In agreement with previous literature, we found that participants tended to underestimate the target numbers. However, in the presence of the illusory patterns, participants were less inclined to underestimate the number of vertically aligned white dots. This reflects the perceptual biases underlying horizontal-vertical illusions. In addition, we identified an enhanced illusory effect when participants observed vertically aligned white dots in the T shape compared to the L shape, a result that resembles the length bisection bias reported in the spatial domain. Overall, we found the first evidence that numerical estimation differs as a function of the vertical or horizontal displacement of the stimuli. In addition, the involvement of the same perceptual biases observed in spatial tasks supports the idea that spatial and numerical abilities share similar cognitive processes.",2020,"Overall, we found the first evidence that numerical estimation differs as a function of the vertical or horizontal displacement of the stimuli.",[],[],['enhanced illusory effect'],[],[],"[{'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0485014,"Overall, we found the first evidence that numerical estimation differs as a function of the vertical or horizontal displacement of the stimuli.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pecunioso', 'Affiliation': 'Department of General Psychology, University of Padova, Italy.'}, {'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Miletto Petrazzini', 'Affiliation': 'School of Biological and Chemical Science, Queen Mary University of London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agrillo', 'Affiliation': 'Department of General Psychology, University of Padova, Italy; Padua Neuroscience Center, University of Padova, Italy. Electronic address: christian.agrillo@unipd.it.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103053']
2344,32168217,"Efficacy, Safety, and Tolerability of a New Low-Dose Copper and Nitinol Intrauterine Device: Phase 2 Data to 36 Months.","OBJECTIVE


To assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator.
METHODS


Institutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with a 2-year extension. Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns.
RESULTS


A total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients. Over 36 months of observation, we identified two pregnancies (Pearl Index 0.46 [95% CI 0.06-1.67]) and 10 serious adverse events; none were study-related. Successful placement occurred in 283 participants (99.0%). Median (range) continuation times were 2.7 years (0-3.4). We identified five expulsions (1.8%), zero uterine perforations, and one report of pelvic inflammatory disease. Adverse events prompted 30 women (10.6%) to discontinue early in the first year of use with 23 (8.1%) discontinuing for issues of bleeding, pain, or both. Altogether, 107 (37.8%) completed 36 months of device use. Mean bleeding days per cycle decreased from 7.6 in cycle 1 to 5.2 in cycle 13.
CONCLUSION


The novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02446821.
FUNDING SOURCE


Sebela Pharmaceuticals, Inc.",2020,"Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns.
","['Nulliparous women represented 60.8% of the patients', '286 women provided 5,640 cycles evaluable for pregnancy', ""Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016"", 'Institutional review boards at 12 U.S. sites approved this commercially funded project', 'parous and nulliparous women', 'Patients averaged 27.1 years of age']",['New Low-Dose Copper and Nitinol Intrauterine Device'],"['efficacy', 'efficacy, safety, and tolerability', 'Median (range) continuation times', 'Mean bleeding days per cycle', 'Intrauterine device placement', 'placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns', 'Successful placement', 'Efficacy, Safety, and Tolerability']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",286.0,0.25066,"Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns.
","[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Turok', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; the Department of Obstetrics and Gynecology, David Geffen School of Medicine, Los Angeles, California; Health Decisions, Durham, North Carolina; the Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, Pennsylvania; and Sebela Pharmaceuticals, Roswell, Georgia.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Clint', 'Initials': 'C', 'LastName': 'Dart', 'Affiliation': ''}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Schreifels', 'Affiliation': ''}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Katz', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003756']
2345,32176305,Prevalence and Risk Factors of Nonmedical Prescription Opioid Use Among Transgender Girls and Young Women.,"Importance


Nonmedical prescription opioid use is a pressing public health issue in the United States. Transgender youth, including adolescent girls and young women who were assigned male at birth and currently identify as women, female, transgender women, or another diverse gender identity along the transfeminine gender spectrum, are more likely than their cisgender peers to report illicit substance use and meet diagnostic criteria for substance use disorders. However, relatively little is known about the experiences of these populations in the current era of opioid addiction and misuse.
Objective


To report the prevalence of and risk factors associated with lifetime nonmedical prescription opioid use in a high-risk community sample of transgender adolescent girls and young women who are sexually active.
Design, Setting, and Participants


This cross-sectional study used 2012 to 2015 baseline data from Project LifeSkills, a randomized clinical trial of a behavioral intervention to reduce the risk of HIV acquisition and transmission among a diverse sample of transgender adolescent girls and young women recruited from Boston, Massachusetts, and Chicago, Illinois. A total of 297 transgender girls and women aged 16 to 29 years who were sexually active were included in this analysis. Data were analyzed from June 2019 to August 2019.
Exposures


Transgender woman identification.
Main Outcomes and Measures


Self-reported lifetime nonmedical prescription opioid use.
Results


Among 297 transgender adolescent girls and young women (mean [SD] age, 23.4 [3.5] years), 145 (48.8%) identified as non-Hispanic/Latinx black, 76 (25.6%) identified as non-Hispanic/Latinx white, 37 (12.5%) identified as Hispanic/Latinx, 7 (2.4%) identified as non-Hispanic/Latinx Asian, and 32 (10.8%) identified as multiracial or other race/ethnicity. Thirty-five participants (11.8%) reported lifetime nonmedical prescription opioid use. Young transgender women who smoked cigarettes monthly or less (adjusted odds ratio, 3.92; 95% CI, 1.10-13.89) and who smoked daily (adjusted odds ratio, 5.69; 95% CI, 1.87-17.33) had greater odds of nonmedical prescription opioid use compared with those who did not smoke. Additionally, participants who identified as a sexual orientation other than heterosexual, gay, lesbian, or bisexual had significantly greater odds of lifetime nonmedical prescription opioid use compared with those who identified as heterosexual (adjusted odds ratio, 3.69; 95% CI, 1.07-12.72).
Conclusions and Relevance


These findings suggest that transgender adolescent girls and young women have similar prevalence of lifetime nonmedical prescription opioid use compared with the US general population prevalence of 12.5%. These findings may serve as a call-to-action for public health surveillance studies and evidence-based interventions to be comprehensively tailored to examine and respond to specific trends of substance use, particularly opioid use disorder, among transgender populations.",2020,"Young transgender women who smoked cigarettes monthly or less (adjusted odds ratio, 3.92; 95% CI, 1.10-13.89) and who smoked daily (adjusted odds ratio, 5.69; 95% CI, 1.87-17.33) had greater odds of nonmedical prescription opioid use compared with those who did not smoke.","['transgender adolescent girls and young women', 'transgender adolescent girls and young women who are sexually active', 'Transgender Girls and Young Women', '297 transgender adolescent girls and young women (mean [SD] age, 23.4 [3.5] years), 145 (48.8%) identified as non-Hispanic/Latinx black, 76 (25.6%) identified as non-Hispanic/Latinx white, 37 (12.5%) identified as Hispanic/Latinx, 7 (2.4%) identified as non-Hispanic/Latinx Asian, and 32 (10.8%) identified as multiracial or other race/ethnicity', '297 transgender girls and women aged 16 to 29 years who were sexually active were included in this analysis', 'transgender adolescent girls and young women recruited from Boston, Massachusetts, and Chicago, Illinois', 'adolescent girls and young women who were assigned male at birth and currently identify as women, female, transgender women, or another diverse gender identity along the transfeminine gender spectrum, are more likely than their cisgender peers to report illicit substance use and meet diagnostic criteria for substance use disorders']",['behavioral intervention'],['Measures\n\n\nSelf-reported lifetime nonmedical prescription opioid use'],"[{'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0020898', 'cui_str': 'Illinois'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0017249', 'cui_str': 'Gender Identity'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0281875', 'cui_str': 'Illicit medication use'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",297.0,0.0347712,"Young transgender women who smoked cigarettes monthly or less (adjusted odds ratio, 3.92; 95% CI, 1.10-13.89) and who smoked daily (adjusted odds ratio, 5.69; 95% CI, 1.87-17.33) had greater odds of nonmedical prescription opioid use compared with those who did not smoke.","[{'ForeName': 'Arjee J', 'Initials': 'AJ', 'LastName': 'Restar', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Adedotun', 'Initials': 'A', 'LastName': 'Ogunbajo', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Millett', 'Affiliation': 'amfAR, The Foundation for AIDS Research, New York, New York.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherwood', 'Affiliation': 'amfAR, The Foundation for AIDS Research, New York, New York.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': ""Division of Adolescent Medicine, Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'Sari L', 'Initials': 'SL', 'LastName': 'Reisner', 'Affiliation': ""Boston Children's Hospital, Division of General Pediatrics, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': 'Feinberg School of Medicine, Department of Pediatrics, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1015']
2346,32192954,How intergroup relation moderates group bias in Third-Party Punishment.,"Two experiments were conducted to investigate how intergroup relation moderates group bias in Third-Party Punishment (TPP) of selfishness. Participants competed or cooperated with the other group and then performed a TPP task in which they could reduce an allocator's benefits after paying a low cost (paying 1/3 unit deducts 1 unit of the allocator in Experiment 1, n = 76) or a high cost (paying 1 unit deducts 1 unit of the allocator in Experiment 2, n = 81). The results supported the ""mere-preference hypothesis"" of group bias, showing that people were more likely to tolerate their ingroups while punishing outgroups more harshly. Furthermore, when the cost was low, competition increased people's punishment toward outgroups' selfishness but not toward ingroup members, thus enlarging the group bias. When the cost was high, however, this effect disappeared, indicating that people consider a ""cost-to-impact ratio"" when selectively enforcing the fairness norm in intergroup conflicts. Our findings suggest how intergroup relation and cost-benefit analysis interact together to influence the group bias in TPP, providing insights into mechanisms underlying the maintenance of fairness norms and decision-making in a group context.",2020,Two experiments were conducted to investigate how intergroup relation moderates group bias in Third-Party Punishment (TPP) of selfishness.,[],['intergroup relation moderates group bias in Third-Party Punishment (TPP) of selfishness'],[],[],"[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0006912', 'cui_str': 'Death Penalty'}]",[],,0.0133281,Two experiments were conducted to investigate how intergroup relation moderates group bias in Third-Party Punishment (TPP) of selfishness.,"[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': 'Department of Psychology, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Jianshu', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Department of Psychology, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, Tsinghua University, Beijing 100084, China. Electronic address: zhen-wu@mail.tsinghua.edu.cn.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103055']
2347,32199245,Perspective-shifting are helpful for children in Chinese passive sentence comprehension.,"Passive sentences have been shown to be more difficult than active sentences for young children in English, German, Italian, Turkish, as well as Japanese, Korean. Many factors, such as syntactic structure, lexical-semantic, language experience, have been proved to affect passive sentence processing. In this paper, two experiments were carried out to investigate the role of perspective-shifting and animacy characteristics of agents and patients in processing passive sentences by 5~6 year-old Chinese children, using a sentence-picture matching task. The results were as follows: (1) Passive sentences were more difficult to comprehend than active sentences in Mandarin Chinese; (2) The ability of perspective-shifting played an important role in processing passive sentences. In sum, addressing sentences involving syntactic transformation is a complex cognitive activity for young children. Many factors, such as syntactic structure, lexical-semantic, language experience, and cognitive flexibility should be given full consideration.",2020,"Passive sentences have been shown to be more difficult than active sentences for young children in English, German, Italian, Turkish, as well as Japanese, Korean.","['children in Chinese passive sentence comprehension', 'young children', '5~6\xa0year-old Chinese children, using a sentence-picture matching task']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",[],[],2.0,0.0175745,"Passive sentences have been shown to be more difficult than active sentences for young children in English, German, Italian, Turkish, as well as Japanese, Korean.","[{'ForeName': 'Wenguang', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'School of Education, Qufu Normal University, Qufu 273165, China. Electronic address: hewg@qfnu.edu.cn.'}, {'ForeName': 'Xinghua', 'Initials': 'X', 'LastName': 'Bi', 'Affiliation': 'School of Education, Qufu Normal University, Qufu 273165, China.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103059']
2348,32892271,Video-Based Guided Simulation without Peer or Expert Feedback is Not Enough: A Randomized Controlled Trial of Simulation-Based Training for Medical Students.,"BACKGROUND


Feedback is a pivotal cornerstone and a challenge in psychomotor training. There are different teaching methodologies; however, some may be less effective.
METHODS


A prospective randomized controlled trial was conducted in 130 medical students to compare the effectiveness of the video-guided learning (VLG), peer-feedback (PFG) and the expert feedback (EFG) for teaching suturing skills. The program lasted 4 weeks. Students were recorded making 3-simple stitches (pre-assessment and post-assessment). The primary outcome was a global scale (OSATS). The secondary outcomes were performance time, specific rating scale (SRS) and the impact of the intervention (IOI), defined as the variation between the final and initial OSATS and SRS scores.
RESULTS


No significant differences were found between PFG and EFG in post-assessment results of OSATS, SRS scores or in the IOI for OSATS and SRS scores. Post-assessment results of PFG and EFG were significantly superior to VLG in OSATS and SRS scores [(19.8 (18.5-21); 16.6 (15.5-17.5)) and (20.3 (19.88-21); 16.8 (16-17.5)) vs (15.7 (15-16); 13.3 (12.5-14)) (p < 0.05)], respectively. The results of PFG and EFG were significantly superior to VLG in the IOI for OSATS [7 (4.5-9) and 7.4 (4.88-10) vs 3.5 (1.5-6) (p < 0.05)] and SRS scores [5.4 (3.5-7) and 6.3 (4-8.5) vs 3.1 (1.13-4.88) (p < 0.05)], respectively.
CONCLUSION


The video-guided learning methodology without any kind of feedback is not enough for teaching suturing skills compared to expert or peer feedback. The peer feedback methodology appears to be a viable alternative to handling the emerging demands in medical education.",2020,"No significant differences were found between PFG and EFG in post-assessment results of OSATS, SRS scores or in the IOI for OSATS and SRS scores.","['Medical Students', '130 medical students']","['video-guided learning (VLG), peer-feedback (PFG) and the expert feedback (EFG', 'Video-Based Guided Simulation without Peer or Expert Feedback', 'Simulation-Based Training', 'OSATS']","['performance time, specific rating scale (SRS) and the impact of the intervention (IOI), defined as the variation between the final and initial OSATS and SRS scores', 'OSATS, SRS scores or in the IOI for OSATS and SRS scores', 'PFG and EFG', 'global scale (OSATS', 'VLG in OSATS and SRS scores', 'SRS scores']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",130.0,0.0497355,"No significant differences were found between PFG and EFG in post-assessment results of OSATS, SRS scores or in the IOI for OSATS and SRS scores.","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Tejos', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Crovari', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Achurra', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Avila', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Inzunza', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Jarry', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile.'}, {'ForeName': 'Arnoldo', 'Initials': 'A', 'LastName': 'Riquelme', 'Affiliation': 'Department of Gastroenterology and Centre for Medical Education, Faculty of Medicine, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, 8330077, Santiago, Chile.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Alseidi', 'Affiliation': 'Department of Surgery, University of California San Francisco, 400 Parnassus Ave, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Varas', 'Affiliation': 'Experimental Surgery and Simulation Center, Department of Digestive Surgery, Faculty of Medicine, Pontificia Universidad Católica de Chile, Marcoleta 377, 8330024, Santiago, Chile. jevaras@uc.cl.'}]",World journal of surgery,['10.1007/s00268-020-05766-x']
2349,32892297,Influence of Male Partners on HIV Disclosure Among South African Women in a Cluster Randomized PMTCT Intervention.,"Disclosure of HIV serostatus is beneficial for women, their partners, and their infants as it enables women to actively participate in preventative care (Hodgson et al. in PLoS ONE 9(11):e111421, 2014; Odiachi et al. in Reprod Health 15(1):36, 2018). Therefore, it is important that interventions addressing HIV prevention include elements that foster disclosure of HIV to partners. This study conducted in South Africa utilizes the ""Protect Your Family"" (PYF) behavioral intervention and compares Prevention of Mother to Child Transmission (PMTCT) among women participating in the program versus those in a control program. Within both groups, male partners were either present or not present for the intervention. The purpose of this study was to examine differential disclosure over time for individuals in the different conditions and partner involvement. A firth logistic regression revealed an interaction in the experimental condition with male partners participating (b = - 2.84, SE = 1.56, p = .012), in which female participants were less likely to disclose their HIV status over time. Findings from this study illustrate that additional efforts are needed to empower women to disclose their HIV status.",2020,"A firth logistic regression revealed an interaction in the experimental condition with male partners participating (b = - 2.84, SE = 1.56, p = .012), in which female participants were less likely to disclose their HIV status over time.","['women participating in the program versus those in a control program', 'Male Partners on HIV Disclosure Among South African Women', 'individuals in the different conditions and partner involvement']","['Protect Your Family"" (PYF) behavioral intervention and compares Prevention of Mother to Child Transmission (PMTCT']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0282474', 'cui_str': 'Infection Transmission, Maternal-Fetal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],,0.0189652,"A firth logistic regression revealed an interaction in the experimental condition with male partners participating (b = - 2.84, SE = 1.56, p = .012), in which female participants were less likely to disclose their HIV status over time.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Dominion Towers Suite 404, 1400 NW 10th Avenue, Miami, FL, 33136, USA.'}, {'ForeName': 'Manasi S', 'Initials': 'MS', 'LastName': 'Parrish', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, USA.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, USA.'}, {'ForeName': 'Shandir', 'Initials': 'S', 'LastName': 'Ramlagan', 'Affiliation': 'HIV/AIDS/STIs and TB Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'Sibusiso', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS/STIs and TB Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Dominion Towers Suite 404, 1400 NW 10th Avenue, Miami, FL, 33136, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Dominion Towers Suite 404, 1400 NW 10th Avenue, Miami, FL, 33136, USA. djones@med.miami.edu.'}]",AIDS and behavior,['10.1007/s10461-020-03021-x']
2350,32892305,Investigation on chronic tinnitus efficacy of combination of non-repetitive preferred music and educational counseling: a preliminary study.,"PURPOSE


To improve the efficacy of music therapy on tinnitus relief, specific music that was not repetitively played and satisfies individualized preference was developed. The aim of this study was to investigate effects of combination of the specific music and educational counseling on tinnitus relief in short term.
METHODS


Sixty patients suffering from chronic tinnitus were included. The non-randomized controlled study was designed with two intervention groups: educational counseling (EC, which included a 1-h individualized instruction) and preferred music therapy [PMT, which included EC plus 15, 30-min preferred music sessions (PMS)]. Three assessments-the Chinese-Mandarin version of Tinnitus Handicap Inventory (THI-CM), Tinnitus Evaluation Questionnaire (TEQ), and Visual Analogue Scale (VAS) were administered before and 1, 2, 3 weeks after initiation of treatment to evaluate the efficacy.
RESULTS


Twenty-six patients in PMT group attained a clinically meaningful improvement in THI compared to 15 in the EC group, though both groups achieved a statistically relevant reduction in the 3 assessments.
CONCLUSION


The PMT had a positive impact on chronic tinnitus and related distress in a short term. It outperformed the separate EC, which is an appropriate treatment option in clinic. Therefore, it presents a possible complement to the therapeutic spectrum in chronic tinnitus.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900022624. Registered on 19 April 2019.",2020,"RESULTS


Twenty-six patients in PMT group attained a clinically meaningful improvement in THI compared to 15 in the EC group, though both groups achieved a statistically relevant reduction in the 3 assessments.
",['Sixty patients suffering from chronic tinnitus were included'],"['music therapy', 'specific music and educational counseling', 'educational counseling (EC, which included a 1-h individualized instruction) and preferred music therapy [PMT, which included EC plus 15, 30-min preferred music sessions (PMS', 'combination of non-repetitive preferred music and educational counseling', 'PMT']","['tinnitus relief', 'chronic tinnitus and related distress', 'THI', 'Chinese-Mandarin version of Tinnitus Handicap Inventory (THI-CM), Tinnitus Evaluation Questionnaire (TEQ), and Visual Analogue Scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376356', 'cui_str': 'Premenstrual tension syndrome'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0272238', 'cui_str': 'Transient hypogammaglobulinemia of infancy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",60.0,0.193372,"RESULTS


Twenty-six patients in PMT group attained a clinically meaningful improvement in THI compared to 15 in the EC group, though both groups achieved a statistically relevant reduction in the 3 assessments.
","[{'ForeName': 'Jiemei', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhong', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology/Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhaoli', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology/Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Pan', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China.'}, {'ForeName': 'Leiyu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jingzhe', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology/Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'College of Electronics and Information Engineering, Sichuan University, Chengdu, China. hpysbsy@163.com.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology/Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, China. 1141679315@qq.com.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06340-w']
2351,32892320,Spirulina supplementation improves oxygen uptake in arm cycling exercise.,"PURPOSE


Spirulina has previously been reported to improve high-intensity exercise performance and hemoglobin. However, spirulina's effect on arm cycling exercise has yet to be investigated. The purpose of this study was to investigate the responses of spirulina supplementation on hemoglobin and on oxygen uptake, RER and HR during seated arm cycling exercise.
METHODS


In a double-blinded randomized crossover design, eleven males untrained in arm cycling ingested 6 g/day of spirulina or placebo for seven days. Seated on the Arm Crank Ergometer, each participant performed a baseline V̇O 2max  test, and then after supplementation, 2 × 30-min submaximal exercise bouts corresponding to 55% of their V̇O 2max , followed by an incremental test to fatigue. A seven-day wash-out period was required between conditions. Oxygen uptake, RER and HR were measured continuously during exercise and hemoglobin measured prior to exercise after both conditions.
RESULTS


Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9). After spirulina supplementation, during the 30-min exercise bouts, oxygen uptake and HR were significantly lower (2170 ml/min ± 173 Vs 2311 ml/min ± 189 and 154 bpm ± 14 Vs 149 bpm ± 17), RER was not significantly different. In comparison to placebo, Spirulina significantly increased oxygen uptake at time of fatigue (34.10 ml/min/kg ± 6.03 Vs 37.37 ml/min/kg ± 5.98). Time taken to fatigue was not different.
CONCLUSION


Spirulina supplementation significantly reduces oxygen uptake and HR during arm cycling submaximal exercise, allowing for an increased oxygen uptake during an incremental test to fatigue.",2020,"RESULTS


Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9).",['eleven males untrained in arm'],"['placebo', 'Placebo', 'cycling ingested 6\xa0g/day of spirulina or placebo', 'Spirulina supplementation']","['oxygen uptake and HR', 'Oxygen uptake, RER and HR', 'oxygen uptake', 'oxygen uptake at time of fatigue', 'Time taken to fatigue', 'RER', 'hemoglobin and on oxygen uptake, RER and HR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",11.0,0.401488,"RESULTS


Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9).","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Gurney', 'Affiliation': 'School of Life Sciences, Kingston University, London, KT1 2EE, UK. T.Gurney@kingston.ac.uk.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Spendiff', 'Affiliation': 'School of Life Sciences, Kingston University, London, KT1 2EE, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04487-2']
2352,32892358,"Getting Fewer ""Likes"" Than Others on Social Media Elicits Emotional Distress Among Victimized Adolescents.","Three studies examined the effects of receiving fewer signs of positive feedback than others on social media. In Study 1, adolescents (N = 613, M age   = 14.3 years) who were randomly assigned to receive few (vs. many) likes during a standardized social media interaction felt more strongly rejected, and reported more negative affect and more negative thoughts about themselves. In Study 2 (N = 145), negative responses to receiving fewer likes were associated with greater depressive symptoms reported day-to-day and at the end of the school year. Study 3 (N = 579) replicated Study 1's main effect of receiving fewer likes and showed that adolescents who already experienced peer victimization at school were the most vulnerable. The findings raise the possibility that technology which makes it easier for adolescents to compare their social status online-even when there is no chance to share explicitly negative comments-could be a risk factor that accelerates the onset of internalizing symptoms among vulnerable youth.",2020,"In Study 2 (N = 145), negative responses to receiving fewer likes were associated with greater depressive symptoms reported day-to-day and at the end of the school year.","['adolescents (N\xa0=\xa0613, M age  \xa0=\xa014.3\xa0years', 'Victimized Adolescents']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],[],,0.0261897,"In Study 2 (N = 145), negative responses to receiving fewer likes were associated with greater depressive symptoms reported day-to-day and at the end of the school year.","[{'ForeName': 'Hae Yeon', 'Initials': 'HY', 'LastName': 'Lee', 'Affiliation': 'University of Texas at Austin.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Jamieson', 'Affiliation': 'University of Rochester.'}, {'ForeName': 'Harry T', 'Initials': 'HT', 'LastName': 'Reis', 'Affiliation': 'University of Rochester.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Beevers', 'Affiliation': 'University of Texas at Austin.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Josephs', 'Affiliation': 'University of Texas at Austin.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mullarkey', 'Affiliation': 'University of Texas at Austin.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': ""O'Brien"", 'Affiliation': 'University of Texas at Austin.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Yeager', 'Affiliation': 'University of Texas at Austin.'}]",Child development,['10.1111/cdev.13422']
2353,32892376,Developmental outcome of extremely preterm infants is improved after less invasive surfactant application (LISA).,"AIM


The aim of this study was to evaluate neurocognitive outcome at 24 months corrected age after less invasive surfactant application (LISA) in p4reterm infants born at 23 - 26 weeks gestational age.
METHODS


Surviving participants of a LISA trial conducted in 13 German level III neonatal intensive care units were reviewed for assessment of developmental outcome, hearing and vision problems, growth and rehospitalization days. Maternal depression, breastfeeding rates and socioeconomic factors were evaluated as potentially confounding factors.
RESULTS


In total, 156/182 infants took part in the study, 78 had received surfactant via LISA and 78 via endotracheal intubation. 22% of LISA infants compared to 42% of intubated infants had a psychomotor development index (PDI)<70 (0.012). A significant difference in mental development index (MDI) was observed in the stratum of more mature infants (25 and26 weeks GA). For this group MDI<70 was observed in 4% of LISA infants versus 21% of intubated infants (p=0.008).
CONCLUSION


At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI. Infants born at 25 and26 weeks treated with LISA had lower rates of severe disability. LISA is safe and may be superior.",2020,At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI.,"['extremely preterm infants', 'p4reterm infants born at 23 - 26 weeks gestational age', 'Surviving participants of a LISA trial conducted in 13 German level III neonatal intensive care units were reviewed for assessment of developmental outcome, hearing and vision problems, growth and rehospitalization days', '156/182 infants took part in the study, 78 had received']","['surfactant via LISA', 'LISA', 'invasive surfactant application (LISA']","['mental development index (MDI', 'psychomotor development index', 'MDI', 'rates of severe disability', 'neurocognitive outcome', 'Maternal depression, breastfeeding rates and socioeconomic factors']","[{'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",,0.0626624,At 24 months of age the LISA treated infants scored less often PDI<70 and had similar results in MDI.,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mehler', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Broer', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': ""Department of Neonatology, Vest Children's Hospital Datteln, University Witten-Herdecke, Witten-Herdecke, Germany.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Göpel', 'Affiliation': 'Department of Pediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Wieg', 'Affiliation': 'Department of Neonatology, Klinikum Aschaffenburg, Aschaffenburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jahn', 'Affiliation': ""Department of Neonatology, Children's Hospital Leverkusen, Leverkusen, Germany.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Teig', 'Affiliation': ""Department of Neonatology, Children's Hospital, Ruhr-University Bochum, Bochum, Germany.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Höhn', 'Affiliation': 'Department of General Pediatrics, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Welzing', 'Affiliation': 'Department of Neonatology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Department of Neonatology, Olga Hospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hoppenz', 'Affiliation': ""Department of Neonatology and Pediatric Intensive Care Medicine, Children's Hospital, Cologne, Germany.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bührer', 'Affiliation': 'Department of Neonatology, Charité University Medical Center, Berlin, Germany.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Roth', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Egbert', 'Initials': 'E', 'LastName': 'Herting', 'Affiliation': 'Department of Pediatrics, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Kribs', 'Affiliation': 'Department of Pediatrics, University of Cologne, Cologne, Germany.'}]","Acta paediatrica (Oslo, Norway : 1992)",['10.1111/apa.15565']
2354,32892392,"Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial.","OBJECTIVE


To evaluate if double-layer uterine closure after a first caesarean section (CS) is superior compared to single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.
DESIGN


Multicentre, double-blind, randomised controlled superiority trial SETTING: 32 hospitals in the Netherlands.
POPULATION


2292 women ≥ 18 years undergoing a first CS were randomly assigned (1:1). 1144 women were assigned to single-layer and 1148 to double-layer closure.
METHODS


Single-layer unlocked closure and double-layer unlocked closure with the second layer imbricating the first.
MAIN OUTCOME MEASURES


Number of days with postmenstrual spotting during one menstrual cycle nine months after CS.
SECONDARY OUTCOMES


perioperative and menstrual characteristics, transvaginal ultrasound measurements.
RESULTS


774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome due to drop-out and amenorrhoea. Mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12 to 1.54) after single-layer and 1.26 (bootstrapped 95% CI 1.07 to 1.45) after double-layer closure (adjusted mean difference -0.07 [95% CI -0.37 to 0.22], p=0.810). Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
CONCLUSIONS


Superiority of double-layer compared to single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted.",2020,"Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
","['1144 women', '2292 women ≥ 18 years undergoing a first CS', ' 32 hospitals in the Netherlands', '774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group']","['Single-layer unlocked closure and double-layer unlocked closure with the second layer imbricating the first', 'double-layer uterine closure after a first caesarean section (CS', 'single- versus double-layer uterine closure during caesarean section']","['niche prevalence', 'Number of days with postmenstrual spotting during one menstrual cycle nine months after CS', 'drop-out and amenorrhoea', 'perioperative and menstrual characteristics, transvaginal ultrasound measurements', 'Operative time', 'Mean number of postmenstrual spotting days']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517873', 'cui_str': '770'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1144.0,0.775289,"Operative time was 3.9 minutes longer (95% CI 3.0 to 4.9, p<0.001) and niche prevalence was 4.8% higher (95% CI 0.01 to 0.09, p=0.027) after double-layer closure.
","[{'ForeName': 'Sanne I', 'Initials': 'SI', 'LastName': 'Stegwee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit, Amsterdam Reproduction & Development, Amsterdam, Netherlands.'}, {'ForeName': 'Lucet F', 'Initials': 'LF', 'LastName': 'van der Voet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Deventer Hospital, Deventer, Netherlands.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jornada Ben', 'Affiliation': 'Department of Health Sciences, Amsterdam Public Health, Faculty of Science, VU University, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit, Amsterdam Reproduction & Development, Amsterdam, Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Univ of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Research School Grow Maastricht University, Veldhoven, Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit, Amsterdam Reproduction & Development, Amsterdam, Netherlands.'}, {'ForeName': 'Christianne Jm', 'Initials': 'CJ', 'LastName': 'de Groot', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit, Amsterdam Reproduction & Development, Amsterdam, Netherlands.'}, {'ForeName': 'Judith Af', 'Initials': 'JA', 'LastName': 'Huirne', 'Affiliation': 'Department of Obstetrics and Gynaecology, Amsterdam UMC, Vrije Universiteit, Amsterdam Reproduction & Development, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16472']
2355,32892481,Fractional CO 2  laser versus trichloroacetic acid 50% for xanthelasma palpebrarum therapy.,"BACKGROUND


Although being a benign lesion, xanthelasma palpebrarum (XP) causes cosmetic concerns. There are numerous therapeutic methods for XP with adverse events for each method.
AIMS


Evaluate the safety, efficacy, and downtime of fractional CO 2  laser (10 600 nm) versus 50% trichloroacetic acid (TCA) in XP therapy.
PATIENTS/METHODS


Comparative interventional prospective study involved 20 adult patients with XP. Each patient received a split-face therapy where xanthelasma lesions treated with fractional CO 2  laser on the one side and TCA 50% on the other side for maximum 5 sessions with 2-week intervals in between.
RESULTS


Statistically significant improvement in lesion color, thickness, and size by both fractional CO 2  and TCA 50%, with nonstatistically significant difference between both therapeutic modalities after treatment, although downtime, number of sessions, and patient's satisfaction were significantly better for fractional CO 2  laser.
CONCLUSION


Fractional CO 2  laser (10 600 nm) is ideal for treatment of xanthelasma because it is safe and effective with short downtime, more patient satisfaction, less sessions, and less complications compared with chemical peeling using TCA (50%).",2020,"Statistically significant improvement in lesion color, thickness, and size by both fractional CO 2  and TCA 50%, with nonstatistically significant difference between both therapeutic modalities after treatment, although downtime, number of sessions, and patient's satisfaction were significantly better for fractional CO 2  laser.
",['20 adult patients with XP'],"['Fractional CO 2  laser versus trichloroacetic acid', 'split-face therapy', 'fractional CO 2  laser on the one side and TCA', 'Fractional CO 2  laser', 'fractional CO 2  laser (10\xa0600\xa0nm) versus 50% trichloroacetic acid (TCA']","['safety, efficacy, and downtime', 'lesion color, thickness, and size by both fractional CO', ""downtime, number of sessions, and patient's satisfaction""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155210', 'cui_str': 'Xanthoma of eyelid'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0041405', 'cui_str': 'Turks and Caicos Islands'}, {'cui': 'C3816748', 'cui_str': '600'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",20.0,0.0282647,"Statistically significant improvement in lesion color, thickness, and size by both fractional CO 2  and TCA 50%, with nonstatistically significant difference between both therapeutic modalities after treatment, although downtime, number of sessions, and patient's satisfaction were significantly better for fractional CO 2  laser.
","[{'ForeName': 'Nissreen Al-Sayed', 'Initials': 'NA', 'LastName': 'Al-Kady', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine (for Girls), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mervat', 'Initials': 'M', 'LastName': 'Hamdino', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine (for Girls), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Faten Abdel Wadoud', 'Initials': 'FAW', 'LastName': 'Abdel Kawy', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine (for Girls), Al-Azhar University, Cairo, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13666']
2356,32892493,Efficacy and Safety of Intralesional Injection of Vitamin D 3  Versus Tuberculin PPD in the Treatment of Plantar Warts: A Comparative Controlled Study.,"BACKGROUND


Several destructive and immunotherapeutic methods are used in treatment of plantar warts, but an effective method with no or reduced recurrence hasn't been found till now.
OBJECTIVES


To evaluate the efficacy and safety of intralesional (IL) vitamin D 3  (Vit D 3  ) injection versus IL tuberculin purified protein derivative (PPD) injection in the treatment of plantar warts.
METHODS


Sixty patients with plantar warts were randomized into 3 equal groups; group I treated using IL tuberculin PPD every 2 weeks, group II treated using IL Vit D 3  every 4 weeks and group III treated with IL saline every 2 weeks till complete clearance or for a maximum of 3 sessions. The follow up period was 6 months.
RESULTS


There was a statistically significant improvement in therapeutic groups than control with more significant improvement in group II than I. As regard number of sessions required for complete response, there was a positive significant correlation in both groups, but more significant in group I. There was a negative correlation between the number of lesions and the response to treatment in both groups. Group II showed significant better response to treatment in male patients. Both modalities were well tolerated, with no remarkable side effects and no recurrence in cured patients of both groups.
CONCLUSIONS


Both IL PPD and Vit D 3  injection are safe and effective for treatment of plantar warts even recalcitrant or multiple, with no post-procedural downtime, better results, and patient satisfaction. IL Vit D 3  injection has a superior advantage than PPD.",2020,There was a statistically significant improvement in therapeutic groups than control with more significant improvement in group II than I.,"['Plantar Warts', 'Sixty patients with plantar warts', 'male patients', 'plantar warts']","['IL tuberculin PPD', 'IL saline', 'Intralesional Injection of Vitamin D 3', 'Tuberculin PPD', 'intralesional (IL) vitamin D 3  (Vit D 3  ) injection versus IL tuberculin purified protein derivative (PPD) injection']","['efficacy and safety', 'Efficacy and Safety']","[{'cui': 'C0042548', 'cui_str': 'Verruca plantaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0243041,There was a statistically significant improvement in therapeutic groups than control with more significant improvement in group II than I.,"[{'ForeName': 'Nahla Elsayed', 'Initials': 'NE', 'LastName': 'Ghaly', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Amal Ahmad', 'Initials': 'AA', 'LastName': 'El-Ashmawy', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Abou Zeid', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Engi Seif E', 'Initials': 'ESE', 'LastName': 'Shaker', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Tanta University, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13712']
2357,32892609,[Assessment of computed tomographic angiographysinus development combined with occipitalbone marks for the location of transverse sigmoid sinus junction].,"Objective:  To introduce and evaluate a technique to precisely localize the transverse-sigmoid sinus junction (TSSJ) in retrosigmoid craniotomy.  Methods:  This was a single-center prospective randomized controlled study. Sixty-three patients, 29 male and 34 female, who would undergo retrosigmoid craniotomy admitted to Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical Universityfrom March to October 2019 were enrolled in the study and were divided into trial group and control group according to the computer-generated random numbers. Preoperative venous computed tomographic angiography (CTA) combined with 3-dimensional computed tomography computed tomography (3D CT) was randomly given to the patients( n= 32). Asterion was used for identification of the TSSJ in the controls ( n= 31). The main outcome measures as postoperative complications and relevant intraoperative indicators were compared.  Results:  Incision length, craniotomy time, bone window sizein trial group were shorter or smaller than those of the controls, as(6.8±0.5) cm vs (8.0±1.5) cm, (37±8) min vs (45±15) min, (8.7±1.2) cm(2) vs (10.2±2.4) cm(2) respectively, with statistical significance (all  P <0.05). No statistical significance was found in bleeding amount, incidence of sinus injury and cerebrospinal fluid leakage. While incidence of neck pain was lower in case group (15.63% vs 38.71%;  P= 0.04) and the remission time of incisional pain in case group was shorter [(6±1) d vs (9±2) d;  P= 0.01].  Conclusion:  While the technique is used, the center of the keyhole should be located at transitional place of the lateral part of the occipitomastoid suture, the retromastoid ridge and the superior nuchal line. Compared with the traditional craniotomy method marked by asterion, it has great advantages in reducing incidence of postoperative complications, craniotomy time, and the remission time of incisional pain.",2020,While incidence of neck pain was lower in case group (15.63% vs 38.71%;  P= 0.04) and the remission time of incisional pain in case group was shorter [(6±1),"['Sixty-three patients, 29 male and 34 female, who would undergo retrosigmoid craniotomy admitted to Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical']","['Preoperative venous computed tomographic angiography (CTA) combined with 3-dimensional computed tomography computed tomography (3D CT', 'computed tomographic angiographysinus development combined with occipitalbone marks']","['Incision length, craniotomy time', 'postoperative complications and relevant intraoperative indicators', 'remission time of incisional pain', 'bleeding amount, incidence of sinus injury and cerebrospinal fluid leakage', 'postoperative complications, craniotomy time, and the remission time of incisional pain', 'neck pain']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442178', 'cui_str': 'Retrosigmoid approach'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0522501', 'cui_str': 'Massive'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0560317', 'cui_str': 'Injury of sinus'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",63.0,0.0238696,While incidence of neck pain was lower in case group (15.63% vs 38.71%;  P= 0.04) and the remission time of incisional pain in case group was shorter [(6±1),"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'Mijiti', 'Initials': 'M', 'LastName': 'Maimaitili', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'L X', 'Initials': 'LX', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'Muertizha', 'Initials': 'M', 'LastName': 'Mamutijiang', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'Gonggaoang', 'Initials': 'G', 'LastName': 'Bate', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Lyu', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}, {'ForeName': 'G H', 'Initials': 'GH', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurosurgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20191210-02695']
2358,32892655,"A Bioequivalence Study of Two Telmisartan 80 mg Tablets in Healthy Indonesian Subjects: An Open Label, Three-way, Three-period, Partial Replicate Crossover Study.","Telmisartan is highly variable drug indicated for treatment of hypertension. This study aimed to compare the bioavailability of two 80 mg telmisartan tablets in healthy Indonesian subjects. A randomized, open-label, single-dose, three-sequence, three-way, reference-formulation-replicated crossover study was conducted under fasting period with two-week washout period. In this study, thirty-one Indonesian subjects were enrolled and twenty-eight subjects were completed the study. Serial blood samples were collected up to 72 hours following drug administration. Plasma concentrations of telmisartan were determined using high performance liquid chromatography method with fluorescence detector. The pharmacokinetic parameters of AUC 0-t , AUC 0-∞ , and C max  were assessed for bioequivalence. Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max . The 90% confidence interval for AUC 0-t , AUC 0-∞ , and C max  were 96.11%-107.25%, 93.06%-104.36%, and 94.23%-127.01%, respectively. These results indicated that the two formulations of telmisartan were bioequivalent.",2020,Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max .,"['healthy Indonesian subjects', 'Healthy Indonesian Subjects', 'thirty-one Indonesian subjects were enrolled and twenty-eight subjects were completed the study']","['telmisartan', 'telmisartan tablets', 'Telmisartan', 'Two Telmisartan']","['Bioequivalence acceptance', 'pharmacokinetic parameters of AUC 0-t , AUC 0-∞ , and C max', 'Plasma concentrations of telmisartan']","[{'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C1248097', 'cui_str': 'telmisartan Oral Tablet'}]","[{'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0248719', 'cui_str': 'telmisartan'}]",31.0,0.0241416,Bioequivalence acceptance was based on predefined criteria of 90% confidence interval of 80.00-125.00% for AUC parameters and reference-scaled-average bioequivalence of 71.73-139.42% for C max .,"[{'ForeName': 'Asti Swari', 'Initials': 'AS', 'LastName': 'Paramanindita', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Yahdiana', 'Initials': 'Y', 'LastName': 'Harahap', 'Affiliation': 'Faculty of Pharmacy, University of Indonesia, Depok.'}, {'ForeName': 'Budi', 'Initials': 'B', 'LastName': 'Prasaja', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Tri Rahayu', 'Initials': 'TR', 'LastName': 'Wijayanti', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Windy', 'Initials': 'W', 'LastName': 'Lusthom', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Raden Efi', 'Initials': 'RE', 'LastName': 'Sofiah', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sandra', 'Affiliation': 'P.T. Clinisindo Laboratories, Jakarta, Indonesia.'}, {'ForeName': 'Yunia', 'Initials': 'Y', 'LastName': 'Trisari', 'Affiliation': 'P.T. Novell Pharmaceutical Laboratories, Jakarta, Indonesia.'}]",Drug development and industrial pharmacy,['10.1080/03639045.2020.1820042']
2359,32892679,Constraint Induced Movement Therapy Camp for Children with Hemiplegic Cerebral Palsy Augmented by Use of an Exoskeleton to Play Games in Virtual Reality.,"AIM


To determine the acceptability and effects of a pediatric constraint induced movement therapy (P-CIMT) camp for children with hemiplegic cerebral palsy (hCP) augmented by use of an exoskeleton to play games in virtual reality (VR).
METHOD


31 children with hCP attended a P-CIMT camp 6 hours per day for 10 days over 2 successive weeks (60 hours) that included 30 minutes of unilateral training with the Hocoma Armeo ® Spring Pediatric that combines the assistance of an exoskeleton and VR games. The primary outcome measure was the Assisting Hand Assessment (AHA); secondary outcome measures were the Melbourne Assessment of Uni-lateral Hand Function (MUUL), and the Canadian Occupational Performance Measure (COPM). Assessments were completed at pre-intervention, post-intervention, and 6 months following intervention.
RESULTS


Participants demonstrated clinically and statistically significant improvement in bimanual performance (AHA) ( p  < .001) and COPM Performance ( p  < .001) and Satisfaction with performance ( p  < .001). Improvement in unilateral performance (MUUL) was statistically ( p  < .001) but not clinically significant.
CONCLUSIONS


A P-CIMT camp augmented by the Hocoma Armeo ® Spring Pediatric was feasible and accepted by participants. Bimanual hand function and occupational performance improved immediately following intervention, and the treatment effects persisted 6 months following intervention.",2020,"RESULTS


Participants demonstrated clinically and statistically significant improvement in bimanual performance (AHA) ( p  < .001) and COPM Performance ( p  < .001) and Satisfaction with performance ( p  < .001).","['Children with Hemiplegic Cerebral Palsy', '31 children with hCP attended a P-CIMT camp 6\u2009hours per day for 10\u2009days over 2 successive weeks (60\u2009hours) that included 30\u2009minutes of', 'children with hemiplegic cerebral palsy (hCP']","['unilateral training with the Hocoma Armeo ® Spring Pediatric that combines the assistance of an exoskeleton and VR games', 'Constraint Induced Movement Therapy Camp', 'pediatric constraint induced movement therapy (P-CIMT) camp', 'exoskeleton to play games in virtual reality (VR']","['Satisfaction with performance', 'Assisting Hand Assessment (AHA); secondary outcome measures were the Melbourne Assessment of Uni-lateral Hand Function (MUUL), and the Canadian Occupational Performance Measure (COPM', 'bimanual performance (AHA', 'COPM Performance', 'unilateral performance (MUUL', 'Bimanual hand function and occupational performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0585022', 'cui_str': 'During day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}]",31.0,0.0477907,"RESULTS


Participants demonstrated clinically and statistically significant improvement in bimanual performance (AHA) ( p  < .001) and COPM Performance ( p  < .001) and Satisfaction with performance ( p  < .001).","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': ""Scottish Rite Hospital for Children, Texas Woman's University, Denton, Texas, USA.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Shierk', 'Affiliation': ""Scottish Rite Hospital for Children, Texas Woman's University, Denton, Texas, USA.""}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Clegg', 'Affiliation': 'Research Department, Scottish Rite for Children, Dallas, Texas, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Research Department, Scottish Rite for Children, Dallas, Texas, USA.'}, {'ForeName': 'Linsley', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Research Department, Scottish Rite for Children, Dallas, Texas, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yeatts', 'Affiliation': ""Department of Neurology, Texas Woman's University, Denton, Texas, USA.""}, {'ForeName': 'Mauricio R', 'Initials': 'MR', 'LastName': 'Delgado', 'Affiliation': 'Department of Neurology, Scottish Rite for Children, Dallas, Texas, USA.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1812790']
2360,32892710,"Sample size determination for Bayesian analysis of small n sequential, multiple assignment, randomized trials (snSMARTs) with three agents.","The small n, Sequential, Multiple Assignment, Randomized Trial (snSMART) is a two-stage clinical trial design for rare diseases motivated by the comparison of three active treatments for isolated skin vasculitis in the ongoing clinical trial ARAMIS (a randomized multicenter study for isolated skin vasculitis, NCT09239573). In Stage 1, all patients are randomized to one of three treatments. In Stage 2, patients who respond to their initial treatment receive the same treatment again, while those who fail to respond are re-randomized to one of the two remaining treatments. A Bayesian method for estimating the response rate of each individual treatment in a three-arm snSMART demonstrated efficiency gains for a given sample size relative to other existing frequentist approaches. However, these efficiency gains are dependent upon knowing how many subjects are required to determine a specific difference in the treatment response rates. Because few sample size calculation methods for snSMARTs exist, we propose a Bayesian sample size calculation for an snSMART designed to distinguish the best treatment from the second-best treatment. Although our methods are based on asymptotic approximations, we demonstrate via simulations that our proposed sample size calculation approach produces the desired statistical power, even in small samples. Moreover, our methods and applet produce sample sizes quickly, thereby saving time relative to using simulations to determine the appropriate sample size. We compare our proposed sample size to an existing frequentist method based upon a weighted  Z  -statistic and demonstrate that the Bayesian method requires far fewer patients than the frequentist method for a study with the same design parameters.",2020,A Bayesian method for estimating the response rate of each individual treatment in a three-arm snSMART demonstrated efficiency gains for a given sample size relative to other existing frequentist approaches.,[],[],[],[],[],[],,0.0814359,A Bayesian method for estimating the response rate of each individual treatment in a three-arm snSMART demonstrated efficiency gains for a given sample size relative to other existing frequentist approaches.,"[{'ForeName': 'Boxian', 'Initials': 'B', 'LastName': 'Wei', 'Affiliation': 'Amgen , Thousand Oaks, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Braun', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health , Ann Arbor, MI, USA.'}, {'ForeName': 'Roy N', 'Initials': 'RN', 'LastName': 'Tamura', 'Affiliation': 'The Division of Bioinformatics and Biostatistics, Pediatric Epidemiology Center, University of South Florida , Tampa, FL, USA.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Kidwell', 'Affiliation': 'Department of Biostatistics, University of Michigan School of Public Health , Ann Arbor, MI, USA.'}]",Journal of biopharmaceutical statistics,['10.1080/10543406.2020.1815032']
2361,32892756,"Predictors of postprandial glycaemia, insulinaemia and insulin resistance in adolescents.","Postprandial glycaemia and insulinaemia are important risk factors for type 2 diabetes. The prevalence of insulin resistance in adolescents is increasing, but it is unknown how adolescent participant characteristics such as BMI, waist circumference, fitness and maturity offset may explain responses to a standard meal. The aim of the present study was to examine how such participant characteristics affect the postprandial glycaemic and insulinaemic responses to an ecologically valid mixed meal. Data from the control trials of three separate randomised, crossover experiments were pooled, resulting in a total of 108 participants (52 boys, 56 girls; age: 12.5±0.6 y; BMI: 19.05±2.66 kg·m-2). A fasting blood sample was taken for the calculation of fasting insulin resistance, using the HOMA-IR model. Further capillary blood samples were taken before and 30-, 60- and 120-min after a standardised lunch, providing 1.5 g.kg-1 body mass of carbohydrate, for the quantification of blood glucose and plasma insulin total area under the curve (tAUC). Hierarchical multiple linear regression demonstrated significant predictors for plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR (F(3, 98)=36.78, p<.001, Adj. R2=.515). The variance in blood glucose tAUC was not significantly explained by the predictors used (F(7, 94)=1.44, p=.198). Significant predictors for HOMA-IR were BMI and maturity offset (F(2, 102)=14.06, p<.001, Adj. R2=.021). In summary, the key findings of the study are that waist circumference, followed by physical fitness, best explained the insulinemic response to an ecologically valid standardised meal in adolescents. This has important behavioural consequences because these variables can be modified.",2020,"Hierarchical multiple linear regression demonstrated significant predictors for plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR (F(3, 98)=36.78, p<.001, Adj.","['108 participants (52 boys, 56 girls; age', 'adolescents']",[],"['plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR', 'postprandial glycaemic and insulinaemic responses', 'blood glucose and plasma insulin total area under the curve (tAUC', 'blood glucose tAUC', 'postprandial glycaemia, insulinaemia and insulin resistance', 'HOMA-IR were BMI and maturity offset', 'Postprandial glycaemia and insulinaemia']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205286', 'cui_str': 'Mature'}]",108.0,0.0171593,"Hierarchical multiple linear regression demonstrated significant predictors for plasma insulin tAUC were waist circumference, physical fitness and HOMA-IR (F(3, 98)=36.78, p<.001, Adj.","[{'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Williams', 'Affiliation': 'Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre; Department of Sport Science; Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Karah J', 'Initials': 'KJ', 'LastName': 'Dring', 'Affiliation': 'Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre; Department of Sport Science; Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Cooper', 'Affiliation': 'Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre; Department of Sport Science; Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Morris', 'Affiliation': 'Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre; Department of Sport Science; Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sunderland', 'Affiliation': 'Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre; Department of Sport Science; Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Nevill', 'Affiliation': 'Exercise and Health Research Group; Sport, Health and Performance Enhancement (SHAPE) Research Centre; Department of Sport Science; Nottingham Trent University, Nottingham, UK.'}]",The British journal of nutrition,['10.1017/S0007114520003505']
2362,32893049,Fermented infant formula (with Bifidobacterium breve C50 and Streptococcus thermophilus O65) with prebiotic oligosaccharides is safe and modulates the gut microbiota towards a microbiota closer to that of breastfed infants.,"BACKGROUND & AIMS


Microbiome-modulators can help positively steer early-life microbiota development but their effects on microbiome functionality and associated safety and tolerance need to be demonstrated. We investigated the microbiome impact of a new combination of bioactive compounds, produced by the food-grade microorganisms Bifidobacterium breve C50 and Streptococcus thermophilus ST065 during a fermentation process, and prebiotics in an infant formula. Tolerance and safety were also assessed.
METHODS


An exploratory prospective, randomized, double-blind, controlled, multi-centre study was designed to investigate the effect of bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) 9:1). Experimental formulas containing these bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM), were compared to a standard cow's milk-based control formula (Control). Exclusively breastfed infants were included as a reference arm since exclusive breastfeeding is considered as the optimal feeding for infants. The study lasted six months and included visits to health care professionals at baseline, two, four and six months of age. Stool SIgA concentration was the primary study outcome parameter.
RESULTS


There were 280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm. Demographics were balanced, growth and tolerance parameters were according to expectation and adverse events were limited. At four months of age the median SIgA concentration in the FERM/scGOS/lcFOS group was significantly higher compared to the Control group (p = 0.03) and was more similar to the concentrations found in the breastfed-reference group. Bifidobacterium increased over time in all groups. The FERM/scGOS/lcFOS combination resulted in a microbiota composition and metabolic activity closer to the breastfed infants' microbiome.
CONCLUSION


The FERM/scGOS/lcFOS combination showed a significant positive effect on SIgA levels. All formulas tested were associated with normal growth and were well-tolerated. Additionally, at four months of age the FERM/scGOS/lcFOS formula brought the microbiome composition and metabolic activity closer towards that of breastfed infants.
CLINICAL TRIAL REGISTRY


Registration number NTR2726 (Netherlands Trial Register; www.trialregister.nl/).",2020,Bifidobacterium increased over time in all groups.,['280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm'],"['prebiotic oligosaccharides', 'bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS']","['Tolerance and safety', 'bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM', 'median SIgA concentration', 'SIgA levels', 'microbiota composition and metabolic activity', 'Bifidobacterium', 'tolerated', 'Stool SIgA concentration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0873033', 'cui_str': 'fructooligosaccharide'}]","[{'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0238394', 'cui_str': 'Female pseudohermaphroditism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0015733', 'cui_str': 'Feces'}]",280.0,0.0672141,Bifidobacterium increased over time in all groups.,"[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Béghin', 'Affiliation': 'Univ. Lille, CHU Lille, Clinical Investigation Center, CIC-1403-Inserm-CHU and U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000, Lille, France.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands. Electronic address: sebastian.tims@danone.com.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Roelofs', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Rougé', 'Affiliation': 'Laboratoire Gallia, Limonest, France.'}, {'ForeName': 'Raish', 'Initials': 'R', 'LastName': 'Oozeer', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands.'}, {'ForeName': 'Thameur', 'Initials': 'T', 'LastName': 'Rakza', 'Affiliation': ""Department of Neonatology, Lille University Jeanne de Flandre Children's Hospital and Faculty of Medicine, University of Lille, F-59000, Lille, France.""}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Chirico', 'Affiliation': 'Department of Neonatology, Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Guus', 'Initials': 'G', 'LastName': 'Roeselers', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Knol', 'Affiliation': 'Danone Nutricia Research, Utrecht, the Netherlands; Laboratory of Microbiology, Wageningen University, the Netherlands.'}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Rozé', 'Affiliation': 'Department of Neonatal Medicine, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Turck', 'Affiliation': ""Univ. Lille, CHU Lille, Clinical Investigation Center, CIC-1403-Inserm-CHU and U1286 - INFINITE - Institute for Translational Research in Inflammation, F-59000, Lille, France; Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Lille University Jeanne de Flandre Children's Hospital and Faculty of Medicine, University of Lille, F-59000, Lille, France.""}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.024']
2363,32893063,"Corrigendum re ""Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial"" [Eur Urol 2019;76:823-30].",,2020,,[],"['Corrigendum re ""Docetaxel Versus Surveillance', 'Radical Radiotherapy']",[],[],"[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0129467,,"[{'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland. Electronic address: pirkko-liisa.kellokumpu-lehtinen@tuni.fi.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hjälm-Eriksson', 'Affiliation': 'Department of Surgery, Capio S.T. Görans Hospital, Stockholm, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg-Karlsson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Lennat', 'Initials': 'L', 'LastName': 'Åström', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Franzen', 'Affiliation': 'Sundsvall University Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Ann-Fofie', 'Initials': 'AF', 'LastName': 'Fransson', 'Affiliation': 'Gävle Central Hospital, Gävle, Sweden.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Leskinen', 'Affiliation': 'Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Mihalj', 'Initials': 'M', 'LastName': 'Zeke', 'Affiliation': 'Växjö Central Hospital, Växjö, Sweden.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Huttunen', 'Affiliation': '4Pharma, Turku, Finland.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.08.035']
2364,32893087,"Effects of a psychological first aid simulated training for pregnant flood victims on disaster relief worker's knowledge, competence, and self-efficacy.","AIMS


To develop a simulation-based psychological first aid (PFA) education program for disaster relief workers and verify its impact on their PFA knowledge, PFA performance competence, and self-efficacy.
BACKGROUND


Relief workers should be provided with systematic education on their required knowledge and skills; however, PFA training for relief workers is lacking, which results in ineffective mental health support during disaster situations.
METHODS


This study adopted a non-equivalent control group pre-posttest quasi-experimental design. Thirty relief workers from mental health welfare centers in Seoul and Gyeonggi Province participated. The experimental group received a PFA lecture, a simulation-based PFA education program, and access to the Psychological Life Support (PLS) mobile application, which provides information on disaster situations and PFA techniques. The comparison group received a PFA lecture. The control group was provided with self-learning PFA materials.
RESULTS


Among the three groups, the experimental group showed the greatest improvement in PFA knowledge, PFA performance competence, and self-efficacy from pretest to posttest, which was statistically significant.
CONCLUSIONS


This study demonstrated the effectiveness of the simulation-based PFA education program combined with a PFA lecture and the PLS mobile app as complementary methods to assist relief workers in applying PFA in disaster situations.",2020,"Among the three groups, the experimental group showed the greatest improvement in PFA knowledge, PFA performance competence, and self-efficacy from pretest to posttest, which was statistically significant.
","['pregnant flood victims', 'Thirty relief workers from mental health welfare centers in Seoul and Gyeonggi Province participated']","['PFA lecture, a simulation-based PFA education program, and access to the Psychological Life Support (PLS) mobile application', 'PFA lecture', 'PFA training', 'simulation-based PFA education program combined with a PFA lecture and the PLS mobile app', 'simulation-based psychological first aid (PFA) education program', 'psychological first aid simulated training']","['PFA knowledge, PFA performance competence, and self-efficacy', ""disaster relief worker's knowledge, competence, and self-efficacy""]","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0016248', 'cui_str': 'Flood'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",30.0,0.025186,"Among the three groups, the experimental group showed the greatest improvement in PFA knowledge, PFA performance competence, and self-efficacy from pretest to posttest, which was statistically significant.
","[{'ForeName': 'Ju-Yeon', 'Initials': 'JY', 'LastName': 'Kang', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul, Republic of Korea.'}, {'ForeName': 'Yun-Jung', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Red Cross College of Nursing, Chung-Ang University, Seoul, Republic of Korea. Electronic address: yunjungchoi@cau.ac.kr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151348']
2365,32893088,The relaxation response: Influence on psychological and physiological responses in patients with COPD.,"In patients with COPD, distress is significantly prevalent and can have adverse psychological and physiological effects. The Relaxation Response Meditation Technique (RRMT), a technique that elicits the relaxation response, was developed by Dr. Herbert Benson to counter the fight-or-flight response to decrease psychological and physiological effects.
AIM


(1) To assess whether implementing the RRMT decreases anxiety in patients with COPD, (2) to determine whether RRMT reduces the patients' perception of breathlessness, and (3) to investigate whether RRMT improves the physiological responses of patients with COPD.
DESIGN


This quasi-experimental study used a pre- and post-test design. The sample (N = 25) consisted of a single group of patients diagnosed in stages 2-4 of COPD at an outpatient pulmonary rehabilitative clinic.
METHODS


Inferential statistics were used to determine the psychological and physiological differences pre- and post-intervention utilizing the State-Trait Anxiety Inventory, Modified Borg Scale, and BP, HR, respiratory rate, and oxygen saturation levels.
RESULTS


Results indicated a significant mean change in anxiety (p ≤ 0.001), perception of dyspnea (p ≤ 0.001), and a decrease in respiratory rate (p = .001) after implementing the RRMT. There was clinical improvement in systolic and diastolic BPs and HR.
CONCLUSION


Findings from this study support the inclusion of the RRMT as part of the pulmonary rehabilitative program to assist patients with COPD in adapting to the negative psychological and physiological responses of distress.",2020,"RESULTS


Results indicated a significant mean change in anxiety (p ≤ 0.001), perception of dyspnea (p ≤ 0.001), and a decrease in respiratory rate (p = .001) after implementing the RRMT.","['patients with COPD', 'patients with COPD, (2', 'The sample (N\xa0=\xa025) consisted of a single group of patients diagnosed in stages 2-4 of COPD at an outpatient pulmonary rehabilitative clinic']","['Relaxation Response Meditation Technique (RRMT', 'RRMT']","['respiratory rate', 'systolic and diastolic BPs and HR', 'anxiety', 'adverse psychological and physiological effects', 'State-Trait Anxiety Inventory, Modified Borg Scale, and BP, HR, respiratory rate, and oxygen saturation levels', 'perception of dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",,0.0365125,"RESULTS


Results indicated a significant mean change in anxiety (p ≤ 0.001), perception of dyspnea (p ≤ 0.001), and a decrease in respiratory rate (p = .001) after implementing the RRMT.","[{'ForeName': 'Crista', 'Initials': 'C', 'LastName': 'Reaves', 'Affiliation': 'Michigan State University, College of Nursing, 1355 Bogue St., Life Science Room #A224, East Lansing, MI 48824-1317, United States of America. Electronic address: mitch350@msu.edu.'}, {'ForeName': 'Alona D', 'Initials': 'AD', 'LastName': 'Angosta', 'Affiliation': 'University of Nevada, Las Vegas School of Nursing, 4505 Maryland Parkway, Box 453018, Las Vegas, NV 89154-3018, United States of America. Electronic address: alona.angosta@unlv.edu.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151351']
2366,32893098,The long-term effect of neurodynamics vs exercise therapy on pain and function in people with carpal tunnel syndrome: A randomized parallel-group clinical trial.,"INTRODUCTION


Carpal tunnel syndrome (CTS) is a common disorder that limits function and quality of life. Little evidence is available on the long-term effect of neurodynamics and exercise therapy.
PURPOSE OF THE STUDY


This study aimed to examine the long-term effect of neurodynamic techniques vs exercise therapy in managing patients with CTS.
STUDY DESIGN


Parallel group randomized clinical trial.
METHODS


Of 57 patients screened, 51 were randomly assigned to either receiving four sessions of neurodynamics and exercise or home exercise therapy alone as a control. Blinded assessment was performed before treatment allocation, at treatment completion, and 6 months posttreatment. Outcome measures included Symptom Severity Scale (SSS), Functional Status Scale (FSS), Shortened version of the Disabilities of the Arm, Shoulder, and Hand (DASH), Numerical Pain Rating Scale, grip strength and range of motion.
RESULTS


Data from 41 individuals (52 hands) were analyzed. The neurodynamics group demonstrated significant improvement in all outcome measures at 1 and 6 months (P < .05). Mean difference in SSS was 1.4 (95% CI= 0.9-1.4) at 1 month and 1.6 (95% CI = 0.9-2.2) at 6 months. Mean difference in FSS was 0.9 (95% CI = 0.4-1.4) at 1 month and 1.4 (95% CI = 0.7-2.0) at 6 months. Significant between-group differences were found in pain score at 1 month (-1.93) and in FSS (-0.5) and Shortened version of DASH (-12.6) at 6 months (P < .05). No patient needed surgery 1 year after treatment.
CONCLUSIONS


Although both treatments led to positive outcomes, neurodynamics therapy was superior in improving function and strength and in decreasing pain.",2020,Significant between-group differences were found in pain score at 1 month (-1.93) and in FSS (-0.5) and Shortened version of DASH (-12.6) at 6 months (P < .05).,"['managing patients with CTS', 'Of 57 patients screened, 51', 'people with carpal tunnel syndrome', '41 individuals (52 hands']","['neurodynamic techniques vs exercise therapy', 'neurodynamics vs exercise therapy', 'neurodynamics and exercise or home exercise therapy alone']","['Mean difference in SSS', 'Mean difference in FSS', 'Symptom Severity Scale (SSS), Functional Status Scale (FSS), Shortened version of the Disabilities of the Arm, Shoulder, and Hand (DASH), Numerical Pain Rating Scale, grip strength and range of motion', 'pain and function', 'function and strength and in decreasing pain', 'pain score', 'FSS (-0.5) and Shortened version of DASH']","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444500', 'cui_str': '0.5'}]",51.0,0.196144,Significant between-group differences were found in pain score at 1 month (-1.93) and in FSS (-0.5) and Shortened version of DASH (-12.6) at 6 months (P < .05).,"[{'ForeName': 'Hayat', 'Initials': 'H', 'LastName': 'Hamzeh', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, The University of Jordan, Amman, Jordan. Electronic address: h.hamzeh@ju.edu.jo.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Madi', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, The Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Alia A', 'Initials': 'AA', 'LastName': 'Alghwiri', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Hawamdeh', 'Affiliation': 'Department of Special Surgery, Orthopaedic and Rehabilitation Medicine Section, School of Medicine, The University of Jordan, Amman, Jordan.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.07.005']
2367,32902905,Improving Adherence to Weight-Loss Medication (Liraglutide 3.0 mg) Using Mobile Phone Text Messaging and Healthcare Professional Support.,"BACKGROUND


Adherence to weight-loss medication is suboptimal, leading to poor health outcomes. Short message service (SMS) can potentially improve adherence.
METHODS


A total of 3,994 participants with overweight or obesity in Australia receiving Saxenda® (liraglutide 3.0 mg) were enrolled from September 1, 2017, to February 28, 2018, through doctors, pharmacists, or websites and were randomly assigned to receive none, three, or five SMS per week. Participants were additionally offered a face-to-face consultation with a diabetes educator or a call from a dietitian. Medication adherence was measured as whether the total scripts claimed were at least as many as the total claims expected by March 31, 2018, and was modeled adjusting for age, sex, baseline BMI, residential region, enrolment channel, the total number of SMS, and additional patient support.
RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week. The effectiveness of SMS on adherence decreased as participants received more SMS over time. Moreover, the odds of adhering to liraglutide were higher for participants enrolled with pharmacists compared with those enrolled with doctors (OR, 2.28; 95% CI: 1.82-2.86) and for participants who received a face-to-face consultation (OR, 3.10; 95% CI: 1.82-5.29) or a call (OR, 1.31; 95% CI: 1.02-1.68) compared with those who received no extra support.
CONCLUSIONS


Integration of SMS into routine clinical practice should consider not only the frequency and content of reminders but also additional patient support to achieve higher and more sustained adherence to medication and health behavior changes.",2020,"RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week.","['3,994 participants with overweight or obesity in Australia receiving Saxenda® (liraglutide 3.0 mg) were enrolled from September 1, 2017, to February 28, 2018, through doctors, pharmacists, or websites', 'Participants were additionally offered a face-to-face consultation with a diabetes educator or a call from a dietitian']","['SMS', 'Weight-Loss Medication (Liraglutide 3.0 mg) Using Mobile Phone Text Messaging and Healthcare Professional Support', 'Short message service (SMS']","['odds of adhering to liraglutide', 'Medication adherence', 'adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C3872102', 'cui_str': 'Saxenda'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",3994.0,0.116125,"RESULTS


Participants receiving five SMS (OR, 6.25; 95% CI: 4.28-9.12) had greater adherence than those receiving three SMS (OR, 3.67; 95% CI: 2.67-5.03) or zero SMS per week.","[{'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Cunich', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Fuller', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Purcell', 'Affiliation': 'Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, New South Wales, Australia.'}, {'ForeName': 'Allanah', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, New South Wales, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Caterson', 'Affiliation': 'Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, Central Clinical School, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22930']
2368,32902928,Feffect of Gluten Ingestion and Fodmap Restriction on Intestinal Epithelial Integrity in Patients with Irritable Bowel Syndrome and Self-reported Non-coeliac Gluten Sensitivity.,"SCOPE


Because epithelial barrier dysfunction has been associated with gluten and FODMAPs, this study aimed to evaluate the effect of alterations in FODMAP intake and blinded, placebo-controlled gluten re-challenge on epithelial barrier function in patients with irritable bowel syndrome (IBS) who self-reported gluten sensitivity.
METHODS AND RESULTS


Circulating concentrations of markers of epithelial injury (syndecan-1 and intestinal fatty acid-binding protein) and bacterial translocation (lipopolysaccharide-binding protein and soluble CD14) were measured while consuming habitual gluten-free diet and during challenges with gluten and placebo on a background of low FODMAP intake. In 33 patients with IBS and self-reported gluten sensitivity, syndecan-1 concentrations during their habitual diet were elevated (median 43 ng/mL) compared with 23 ng/mL in 49 healthy subjects (p<0.001), but not other markers. On a low FODMAP diet, symptoms were reduced and levels of syndecan-1 (but not other markers) fell by a median 33-35% irrespective of whether gluten was present or not.
CONCLUSION


Gluten ingestion had no specific effect on epithelial integrity or symptoms in this cohort, but reducing FODMAP intake concomitantly reduced symptoms and reversed apparent colonic epithelial injury. These findings highlight the heterogeneity of populations self-reporting gluten sensitivity and implicate FODMAPs in colonic injury in IBS. This article is protected by copyright. All rights reserved.",2020,"On a low FODMAP diet, symptoms were reduced and levels of syndecan-1 (but not other markers) fell by a median 33-35% irrespective of whether gluten was present or not.
","['33 patients with IBS and self-reported', 'Patients with Irritable Bowel Syndrome and Self-reported Non-coeliac Gluten Sensitivity', 'patients with irritable bowel syndrome (IBS) who self-reported gluten sensitivity']","['Gluten Ingestion and Fodmap Restriction', 'placebo']","['Intestinal Epithelial Integrity', 'epithelial integrity or symptoms', 'gluten sensitivity, syndecan-1 concentrations', 'epithelial injury (syndecan-1 and intestinal fatty acid-binding protein) and bacterial translocation (lipopolysaccharide-binding protein and soluble CD14']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C2711053', 'cui_str': 'Non-celiac gluten sensitivity'}, {'cui': 'C0850024', 'cui_str': 'Gluten sensitivity'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0850024', 'cui_str': 'Gluten sensitivity'}, {'cui': 'C0753253', 'cui_str': 'SDC1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0282583', 'cui_str': 'Bacterial translocation'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}]",33.0,0.0743005,"On a low FODMAP diet, symptoms were reduced and levels of syndecan-1 (but not other markers) fell by a median 33-35% irrespective of whether gluten was present or not.
","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ajamian', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Rosella', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Newnham', 'Affiliation': 'Department of Gastroenterology and Hepatology, Eastern Health, Victoria, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Biesiekierski', 'Affiliation': 'Department of Gastroenterology and Hepatology, Eastern Health, Victoria, Australia.'}, {'ForeName': 'Jane G', 'Initials': 'JG', 'LastName': 'Muir', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Gibson', 'Affiliation': 'Department of Gastroenterology, Monash University and Alfred Health, Melbourne, Australia.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901275']
2369,32897809,Maternal Support Is Protective Against Suicidal Ideation Among a Diverse Cohort of Young Transgender Women.,"Purpose:  We assessed if young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents.  Methods:  This study analyzed baseline findings from a diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015. Bivariate and multivariable logistic regression were used to assess if parental support was associated with a decreased odds of suicidal ideation.  Results:  Nearly one-fifth (18.9%) of YTW reported suicidal ideation at baseline. In our adjusted multivariable model, YTW with supportive mothers had 0.37 (95% confidence interval = 0.15-0.90) times the odds of having suicidal ideation compared with YTW with unsupportive mothers.  Conclusion:  This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity. Our results suggest that parent-focused interventions to improve the relationships between YTW and their parents may lower the odds of YTW having suicidal ideation. Clinical Trial Registration Identifier: NCT01575938.",2020,This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity.,"['diverse sample of 297 sexually active, YTW 16-29 years of age who were enrolled in Project LifeSkills, a randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012 and 2015', 'young transgender women (YTW) with parents who are supportive of their transgender identity had lower odds of having suicidal ideation compared with YTW with unsupportive parents']",[],['suicidal ideation'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]",297.0,0.104996,This study found that the odds of suicidal ideation were lower among YTW who had mothers who were supportive of their transgender identity.,"[{'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Epidemiology and Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Arjee', 'Initials': 'A', 'LastName': 'Restar', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology and Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Adedotun', 'Initials': 'A', 'LastName': 'Ogunbajo', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Biello', 'Affiliation': 'Department of Epidemiology and Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Operario', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Sari L', 'Initials': 'SL', 'LastName': 'Reisner', 'Affiliation': ""Division of General Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Mimiaga', 'Affiliation': 'Department of Epidemiology and Brown University School of Public Health, Providence, Rhode Island, USA.'}]",LGBT health,['10.1089/lgbt.2020.0219']
2370,32897839,Bring back the tubal: An intervention to provide postpartum tubal ligation in the underserved population.,"We aimed to improve educational awareness of postpartum bilateral tubal ligation (PPBTL), which we defined as a 15% improvement between pre-/post-intervention questionnaire scores. We followed patients desiring and undergoing PPBTL and reason for unfulfilled procedures from 2017-2018. OB/GYN, Nursing, and Anesthesia participated in educational sessions with pre-/post-intervention questionnaires. Comparing the first and latter six months after study initiation, PPBTLs performed increased from 39% to 54%. Fifty-two staff participated in the interventions, with a 21% improvement in scores (OB/GYN  p  = 0.0117, Nursing  p  = 0.0001, Anesthesia  p  = 0.0002). We conclude multidisciplinary interventions improved educational awareness, an integral part to increasing PPBTL performance in the underserved.",2020,"Fifty-two staff participated in the interventions, with a 21% improvement in scores (OB/GYN  p  = 0.0117, Nursing  p  = 0.0001, Anesthesia  p  = 0.0002).",['patients desiring and undergoing PPBTL and reason for unfulfilled procedures from 2017-2018'],[],"['educational awareness', 'educational awareness of postpartum bilateral tubal ligation (PPBTL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0589114', 'cui_str': 'Bilateral tubal ligation'}]",,0.0264138,"Fifty-two staff participated in the interventions, with a 21% improvement in scores (OB/GYN  p  = 0.0117, Nursing  p  = 0.0001, Anesthesia  p  = 0.0002).","[{'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Welch', 'Affiliation': 'Department of Obstetrics & Gynecology, Inova Fairfax Medical Campus, Falls Church, Virginia, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Department of Obstetrics & Gynecology, Inova Fairfax Medical Campus, Falls Church, Virginia, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Mauney', 'Affiliation': 'Department of Anesthesiology, Geisinger Health System, Wilkes Barre, Pennsylvania, USA.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'McLeod', 'Affiliation': 'Department of Obstetrics & Gynecology, Inova Fairfax Medical Campus, Falls Church, Virginia, USA.'}]",Health care for women international,['10.1080/07399332.2020.1805747']
2371,32897975,Advantages of Small Bone-Window Craniotomy Under Microscope Combined Post-operative Intracranial Pressure (ICP) Monitoring in the Treatment of Hypertensive Intracerebral Hemorrhage (HICH).,"OBJECTIVE


The aim of this study is to analyze the clinical effect of small bone-window craniotomy with microscope combined postoperative ICP monitoring, and further explore an appropriate treatment for HICH patients.
METHODS


One hundred fifty patients with HICH were selected according to inclusion and exclusion criteria and divided into 3 groups at random, 50 each group. Patients in 3 groups were treated with conventional craniotomy, small bone-window craniotomy and small bone-window craniotomy combined ICP monitoring respectively. The surgical efficiency, treatment effect and outcomes were recorded and analyzed.
RESULTS


The intraoperative blood loss and operation time of small window groups were significantly less than that of conventional group, and the hematoma clearance rate in small window groups were significantly higher than in conventional group (P < 0.05). Compared with conventional group, the hospital stays and mannitol dose used were less in small window groups and least in small window combined ICP monitoring group (P < 0.05). The complication rate in small window combined ICP monitoring group was 10%, which was significantly lower than in conventional group (26%, P < 0.05), while no significant difference was found between small window group (18%) compared with the other 2 groups respectively (P > 0.05). The difference of morality rate between 3 groups wasn't significant (P > 0.05). Three treatment significantly increased the Barthel index score, and the improvement of small window combined ICP monitoring group was significantly higher than in other 2 groups respectively (P < 0.05), while the difference between this two groups wasn't significant (P > 0.05).
CONCLUSION


Small bone-window craniotomy is more efficient and convenient than conventional craniotomy in the treatment of HICH. In the meantime, small bone-window craniotomy simultaneous with ICP monitoring significantly improved clinical effect and treatment outcomes of HICH patients.",2020,"Three treatment significantly increased the Barthel index score, and the improvement of small window combined ICP monitoring group was significantly higher than in other 2 groups respectively (P < 0.05), while the difference between this two groups wasn't significant (P > 0.05).
","['Hypertensive Intracerebral Hemorrhage (HICH', 'One hundred fifty patients with HICH were selected according to inclusion and exclusion criteria and divided into 3 groups at random, 50 each group', 'HICH patients']","['Small Bone-Window Craniotomy', 'Under Microscope Combined Post-operative Intracranial Pressure (ICP', 'small bone-window craniotomy with microscope combined postoperative ICP monitoring', 'conventional craniotomy, small bone-window craniotomy and small bone-window craniotomy combined ICP monitoring respectively', 'Small bone-window craniotomy']","['morality rate', 'hospital stays', 'Barthel index score', 'complication rate', 'hematoma clearance rate', 'intraoperative blood loss and operation time']","[{'cui': 'C0751892', 'cui_str': 'Hypertensive Hemorrhage, Cerebral'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0182380', 'cui_str': 'Intracranial pressure monitor'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.032752,"Three treatment significantly increased the Barthel index score, and the improvement of small window combined ICP monitoring group was significantly higher than in other 2 groups respectively (P < 0.05), while the difference between this two groups wasn't significant (P > 0.05).
","[{'ForeName': 'Donghai', 'Initials': 'D', 'LastName': 'Men', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Guangdong Medical University, Zhangjiang, Guangdong, China.'}, {'ForeName': 'Zixiong', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Weichuan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huanqiang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Chengjie', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006986']
2372,32898024,"Acupuncture ameliorated vasomotor symptoms during menopausal transition: single-blind, placebo-controlled, randomized trial to test treatment efficacy.","OBJECTIVES


This study aimed to evaluate the effects of acupuncture on women with vasomotor symptoms during the menopausal transition with the aid of the Kupperman-Blatt Menopausal Index.
METHOD


Crossover, single-blind, sham-controlled trial with 100 women randomly divided into two groups of 50 participants each: G1 and G2. During the first 24 weeks of treatment, the G1 women received acupuncture and the G2 women were given sham acupuncture. The crossover was then applied: the G1 participants were given sham acupuncture, and the G2 participants received acupuncture for 24 more weeks.
RESULTS


The mean score of hot flashes of the group who first experienced acupuncture (G1) was statistically higher than that of the group that started with sham acupuncture (G2, P = 0.020). Also, both groups had similar mean scores in the middle of the study (both were receiving acupuncture). During the last 6 months of the study, after crossover, the values of G2 (acupuncture) were lower than those of G1 (sham acupuncture).
CONCLUSIONS


Acupuncture treatment may mitigate hot flashes and other climacteric symptoms during the menopausal transition. : Video Summary:http://links.lww.com/MENO/A641.",2020,"The mean score of hot flashes of the group who first experienced acupuncture (G1) was statistically higher than that of the group that started with sham acupuncture (G2, P = 0.020).","['100 women randomly divided into two groups of 50 participants each: G1 and G2', 'women with vasomotor symptoms during the menopausal transition with the aid of the Kupperman-Blatt Menopausal Index']","['Acupuncture', 'sham acupuncture', ' Video Summary:http://links.lww.com/MENO/A641', 'acupuncture', 'placebo']","['climacteric symptoms', 'vasomotor symptoms', 'values of G2 (acupuncture', 'mean score of hot flashes']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1306878', 'cui_str': 'Climacteric discomfort'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}]",100.0,0.171546,"The mean score of hot flashes of the group who first experienced acupuncture (G1) was statistically higher than that of the group that started with sham acupuncture (G2, P = 0.020).","[{'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Soares-Jr', 'Affiliation': 'Disciplina de Ginecologia, Departamento de Obstetrícia e Ginecologia, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Branco-de-Luca', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'da Fonseca', 'Affiliation': ''}, {'ForeName': 'Ceci M', 'Initials': 'CM', 'LastName': 'Carvalho-Lopes', 'Affiliation': ''}, {'ForeName': 'Eduardo C', 'Initials': 'EC', 'LastName': 'Arruda-Veiga', 'Affiliation': ''}, {'ForeName': 'Cristiane L', 'Initials': 'CL', 'LastName': 'Roa', 'Affiliation': ''}, {'ForeName': 'Vicente R', 'Initials': 'VR', 'LastName': 'Bagnoli', 'Affiliation': ''}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001651']
2373,32898029,De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial.,"OBJECTIVE


To evaluate the feasibility and preliminary efficacy of a de-implementation intervention to support return-to-activity guideline use after concussion.
SETTING


Community.
PARTICIPANTS


Family physicians in community practice (n = 21 at 5 clinics).
DESIGN


Pilot stepped wedge cluster randomized trial with qualitative interviews. Training on new guidelines for return to activity after concussion was provided in education outreach visits.
MAIN MEASURES


The primary feasibility outcomes were recruitment, retention, and postencounter form completion (physicians prospectively recorded what they did for each new patient with concussion). Efficacy indicators included a knowledge test and guideline compliance based on postencounter form data. Qualitative interviews covered Theoretical Domains Framework elements.
RESULTS


Recruitment, retention, and postencounter form completion rates all fell below feasibility benchmarks. Family physicians demonstrated increased knowledge about the return-to-activity guideline (M = 8.8 true-false items correct out of 10 after vs 6.3 before) and improved guideline adherence (86% after vs 25% before) after the training. Qualitative interviews revealed important barriers (eg, beliefs about contraindications) and facilitators (eg, patient handouts) to behavior change.
CONCLUSIONS


Education outreach visits might facilitate de-implementation of prolonged rest advice after concussion, but methodological changes will be necessary to improve the feasibility of a larger trial. The qualitative findings highlight opportunities for refining the intervention.",2020,Family physicians demonstrated increased knowledge about the return-to-activity guideline (M = 8.8 true-false items correct out of 10 after vs 6.3 before) and improved guideline adherence (86% after vs 25% before) after the training.,"['Family physicians in community practice (n = 21 at 5 clinics', 'Community']","['De-implementing Prolonged Rest Advice for Concussion', 'de-implementation intervention']","['important barriers (eg, beliefs about contraindications) and facilitators (eg, patient handouts) to behavior change', 'knowledge about the return-to-activity guideline', 'recruitment, retention, and postencounter form completion (physicians', 'guideline adherence', 'Recruitment, retention, and postencounter form completion rates']","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0525059', 'cui_str': 'Guideline Adherence'}]",,0.0427984,Family physicians demonstrated increased knowledge about the return-to-activity guideline (M = 8.8 true-false items correct out of 10 after vs 6.3 before) and improved guideline adherence (86% after vs 25% before) after the training.,"[{'ForeName': 'Noah D', 'Initials': 'ND', 'LastName': 'Silverberg', 'Affiliation': ""Division of Physical Medicine & Rehabilitation (Dr Silverberg), Rehabilitation Sciences (Ms Otamendi), and Departments of Psychiatry (Dr Panenka), Pediatrics (Dr Babul), and Physical Therapy (Dr Li), The University of British Columbia, Vancouver, Canada; Rehabilitation Research Program, Vancouver Coastal Health Research Institute, Vancouver, British Columbia, Canada (Dr Silverberg and Ms MacLellan); BC Mental Health & Substance Use Services Research Institute, Vancouver, British Columbia, Canada (Dr Panenka); British Columbia Provincial Neuropsychiatry Program, Vancouver, British Columbia, Canada (Dr Panenka); Department of Family Medicine and Emergency Medicine, Université Laval, Québec City, Quebec, Canada (Dr Archambault); Centre intégré de santé et de services sociaux de Chaudière-Appalaches, Ste-Marie, Ontario, Canada (Dr Archambault); Centre de recherche intégrée pour un système apprenant en santé et services sociaux, Lévis, Quebec, Canada (Dr Archambault); Centre de recherche sur les soins et les services de première ligne de l'Université Laval, Québec City, Quebec, Canada (Dr Archambault); Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Université Laval, Québec City, Quebec, Canada (Dr Archambault); BC Injury Research and Prevention Unit, BC Children's Hospital, Vancouver, British Columbia, Canada (Dr Babul); and Arthritis Research Canada, Richmond, British Columbia, Canada (Dr Li); on behalf of the Canadian TBI Research Consortium.""}, {'ForeName': 'Thalia', 'Initials': 'T', 'LastName': 'Otamendi', 'Affiliation': ''}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Panenka', 'Affiliation': ''}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Archambault', 'Affiliation': ''}, {'ForeName': 'Shelina', 'Initials': 'S', 'LastName': 'Babul', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'MacLellan', 'Affiliation': ''}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000609']
2374,32898050,Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?,"OBJECTIVES


There is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity.
METHODS


This is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22.
RESULTS


A total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138).
CONCLUSIONS


In this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.",2020,"At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI.",['351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data'],"['strenuous exercise', 'Pelvic Muscle Training', 'sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS']","['symptomatic SUI', 'Symptomatic Stress Urinary Incontinence']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3178892', 'cui_str': 'Pelvic Floor Diseases'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0448421', 'cui_str': 'Skeletal muscle structure of pelvis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]",351.0,0.0541035,"At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI.","[{'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Ferrante', 'Affiliation': 'From the Division of Urogynecology, Kaiser Permanente San Diego, San Diego, CA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'Center for Clinical Research Network Coordination, Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Amaanti', 'Initials': 'A', 'LastName': 'Sridhar', 'Affiliation': 'Center for Clinical Research Network Coordination, Biostatistics and Epidemiology Division, RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Division of Urology, University of Pennsylvania Health System, Philadelphia, PA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Rahn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Ellington', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Wohlrab', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Infants Hospital, Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ""Division of Urogynecology and Pelvic Reconstructive Surgery, Magee Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, PA.""}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Lukacz', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, University of California, San Diego, San Diego, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000893']
2375,32898271,"Comparison of A(H3N2) neutralizing antibody responses elicited by 2018-2019 season quadrivalent influenza vaccines derived from eggs, cells, and recombinant hemagglutinin.","BACKGROUND


Low vaccine effectiveness against A(H3N2) influenza in seasons with little antigenic drift has been attributed to substitutions in hemagglutinin (HA) acquired during vaccine virus propagation in eggs. Clinical trials comparing recombinant HA vaccine (rHA) and cell-derived inactivated influenza vaccine (IIV) to egg-derived IIVs provide opportunities to assess how egg-adaptive substitutions influence HA immunogenicity.
METHODS


Neutralization titers in pre- and post-immunization sera from 133 adults immunized with one of three types of influenza vaccines in a randomized, open-label trial during the 2018-2019 influenza season were measured against egg- and cell-derived A/Singapore/INFIMH-16-0019/2016-like and circulating A(H3N2) influenza viruses using HA-pseudoviruses.
RESULTS


All vaccines elicited neutralizing antibodies to all H3 vaccine antigens, but the rHA vaccine elicited the highest titers and seroconversion rates against all strains tested. Egg- and cell-derived IIVs elicited responses similar to each other. Pre-immunization titers against H3 HA-pseudoviruses containing egg-adaptive substitutions T160K and L194P were high, but lower against H3 HA-pseudoviruses without those substitutions. All vaccines boosted neutralization titers against HA-pseudoviruses with egg-adaptive substitutions, but poorly neutralized wildtype 2019-2020 A/Kansas/14/2017 (H3N2) HA-pseudoviruses.
CONCLUSION


Egg- and cell-derived 2018-2019 season influenza vaccines elicited similar neutralization titers and response rates, indicating that the cell-derived vaccine did not improve immunogenicity against the A(H3N2) viruses. The higher responses after rHA vaccination may be due to its higher HA content. All vaccines boosted titers to HA with egg-adaptive substitutions, suggesting boosting from past antigens or better exposure of HA epitopes. Studies comparing immunogenicity and effectiveness of different influenza vaccines across many seasons are needed.",2020,"All vaccines boosted neutralization titers against HA-pseudoviruses with egg-adaptive substitutions, but poorly neutralized wildtype 2019-2020","['Neutralization titers in pre- and post-immunization sera from 133 adults immunized with one of three types of influenza vaccines in a randomized, open-label trial during the 2018-2019 influenza season were measured against egg- and cell-derived A/Singapore/INFIMH-16-0019/2016-like and circulating A(H3N2) influenza viruses using HA-pseudoviruses']","['influenza vaccines', 'Kansas/14/2017 (H3N2', 'recombinant HA vaccine (rHA) and cell-derived inactivated influenza vaccine (IIV']",['neutralization titers and response rates'],"[{'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0475208', 'cui_str': 'Titer'}]",133.0,0.0451709,"All vaccines boosted neutralization titers against HA-pseudoviruses with egg-adaptive substitutions, but poorly neutralized wildtype 2019-2020","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Alvarado-Facundo', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Vassell', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Limone', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Defense Health Agency- Immunization Healthcare Division, Arlington Boulevard, Falls Church, VA, USA.'}, {'ForeName': 'Rhonda E', 'Initials': 'RE', 'LastName': 'Colombo', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Ganesan', 'Affiliation': 'Walter Reed National Military Medical Center, Rockville Pike, Bethesda, MD, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Geaney', 'Affiliation': 'Walter Reed National Military Medical Center, Rockville Pike, Bethesda, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hrncir', 'Affiliation': 'Defense Health Agency- Immunization Healthcare Division Regional Office, Wilford Hall Loop, Lackland AFB, TX, USA.'}, {'ForeName': 'Tahaniyat', 'Initials': 'T', 'LastName': 'Lalani', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Ana Elizabeth', 'Initials': 'AE', 'LastName': 'Markelz', 'Affiliation': 'Brooke Army Medical Center, Roger Brooke Dr, JBSA Fort Sam Houston, TX, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Maves', 'Affiliation': 'Division of Infectious Diseases, Naval Medical Center, San Diego, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'McClenathan', 'Affiliation': 'Defense Health Agency- Immunization Healthcare Division Regional Office, Ft. Bragg, NC, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Mende', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Richard', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schofield', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Srihari', 'Initials': 'S', 'LastName': 'Seshadri', 'Affiliation': 'Defense Health Agency- Immunization Healthcare Division, Arlington Boulevard, Falls Church, VA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Spooner', 'Affiliation': 'Defense Health Agency- Immunization Healthcare Division, Arlington Boulevard, Falls Church, VA, USA.'}, {'ForeName': 'Gregory C', 'Initials': 'GC', 'LastName': 'Utz', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Tyler E', 'Initials': 'TE', 'LastName': 'Warkentien', 'Affiliation': 'Naval Medical Center, John Paul Jones Circle, Portsmouth VA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Coles', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Eichelberger', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Carol D', 'Initials': 'CD', 'LastName': 'Weiss', 'Affiliation': 'Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1352']
2376,32898346,A Randomized Controlled Feasibility Trial of Reminder-Focused Positive Psychiatry in Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder.,"Objective


To investigate the impact of reminder-focused positive psychiatry (RFPP) on attention-deficit/hyperactive disorder (ADHD) and posttraumatic stress disorder (PTSD) symptoms, vascular-function, inflammation and well-being of adolescents with comorbid ADHD and PTSD.
Methods


After obtaining informed-consent, 11 adolescents were randomized to RFPP (n = 5) or trauma-focused cognitive-behavioral therapy (TF-CBT) (n = 6). Eight participants (RFPP: n = 4, TF-CBT: n = 4) completed the twice-weekly intervention for a 6-week trial. The RFPP intervention was inclusive of positive psychiatry interventions on (1) traumatic reminders and (2) avoidance and negative cognition. Vascular function measured as temperature rebound, C-reactive protein, homocysteine, ADHD Swanson, Nolan, and Pelham (SNAP) Questionnaire, Clinician-Administered PTSD Scale for DSM-5-Child/Adolescent Version (CAPS-CA), and neuropsychiatric-measures were measured at baseline and 6 weeks. Subjects were followed for 12 months. The study was conducted from September 2016 to June 2018.
Results


A significant improvement in CAPS-CA, SNAP scores, and vascular function of both RFPP and TF-CBT groups was noted at follow-up, but was more-robust in the RFPP group (P < .05). At the sixth week, a significant increase in PERMA, gratitude, resilience, and Posttraumatic Growth Inventory scores and a significant decrease in homocysteine and C-reactive protein levels in the RFPP group, but not the TF-CBT group, were noted (P < .05). At 12-month follow-up, there was no psychiatry hospitalization or suicide ideation reported in either group. A continuation of significant improvement in CAPS-CA and SNAP scores in both groups was noted but was more robust in the RFPP group (P < .05). Similarly, a continuation of significant increase in PERMA, gratitude, resilience and Posttraumatic Growth Inventory scores was noted in the RFPP group but not in the TF-CBT group (P < .05).
Conclusions


RFPP is associated with improvement in core PTSD and ADHD symptoms, decrease in inflammation, and increase in well-being, vascular function, and posttraumatic growth, as well as a favorable long-term clinical outcome. This finding highlights the importance of the dual role of RFPP in addressing vulnerability symptoms as well as enhancing well-being in youth with comorbid ADHD and PTSD.
Trial Registration


ClinicalTrials.gov identifier: NCT04336072.",2020,"A significant improvement in CAPS-CA, SNAP scores, and vascular function of both RFPP and TF-CBT groups was noted at follow-up, but was more-robust in the RFPP group (P < .05).","['Eight participants (RFPP: n = 4, TF-CBT: n = 4', 'Adolescents With Comorbid Attention-Deficit/Hyperactivity Disorder and Posttraumatic Stress Disorder', 'adolescents with comorbid ADHD and PTSD.\nMethods\n\n\nAfter obtaining informed-consent, 11 adolescents', 'September 2016 to June 2018']","['trauma-focused cognitive-behavioral therapy (TF-CBT', 'reminder-focused positive psychiatry (RFPP', 'TF-CBT', 'Reminder-Focused Positive Psychiatry', 'RFPP']","['PERMA, gratitude, resilience, and Posttraumatic Growth Inventory scores', 'psychiatry hospitalization or suicide ideation', 'PERMA, gratitude, resilience and Posttraumatic Growth Inventory scores', 'CAPS-CA, SNAP scores, and vascular function', 'inflammation, and increase in well-being, vascular function, and posttraumatic growth', 'Vascular function measured as temperature rebound, C-reactive protein, homocysteine, ADHD Swanson, Nolan, and Pelham', 'homocysteine and C-reactive protein levels', 'SNAP) Questionnaire, Clinician-Administered PTSD Scale for DSM-5-Child/Adolescent Version (CAPS-CA), and neuropsychiatric-measures', 'CAPS-CA and SNAP scores']","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",11.0,0.0339503,"A significant improvement in CAPS-CA, SNAP scores, and vascular function of both RFPP and TF-CBT groups was noted at follow-up, but was more-robust in the RFPP group (P < .05).","[{'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Olive View UCLA Medical Ctr, 1445 Olive View Dr, Sylmar, CA 91342. ahmadi@ucla.edu.'}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Psychiatry, Kern Medical, Bakersfield, California, USA.'}, {'ForeName': 'Towhid', 'Initials': 'T', 'LastName': 'Salam', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychiatry, Kern Medical, Bakersfield, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kase', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Olango', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Molla', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pynoos', 'Affiliation': 'Department of Psychiatry, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.'}]",The primary care companion for CNS disorders,['10.4088/PCC.19m02579']
2377,32898349,Effects of a personalized physical exercise program in peripheral and central blood pressure in community dwelling old hypertensive adults: the AGA@4life intervention model.,"We aimed at testing the effect of a tailored physical exercise intervention program on brachial and central blood pressure (bBP and cBP, respectively) in a group of hypertensive old adults. Thirty-three participants (mean age: 82 ± 9 years) were divided into two groups (intervention group and control group) according to their adherence to the physical training program. The exercise program included aerobic and strength components, prescribed in a personalized approach, and implemented under a strict control of two experienced professionals. An oscillometric-based device was used to measure bBP and cBP, both at baseline ant 3 months after the intervention period. The groups had similar clinical and demographic characteristics at baseline. No significant changes were observed in any of the considered endpoints in the control group. Conversely, a significant reduction was depicted in the intervention group, for both bBP and cBP. The results demonstrate that physical exercise prescribed in a tailored approach is an effective nonpharmacological tool to reduce pBP and cBP in older adults.",2020,No significant changes were observed in any of the considered endpoints in the control group.,"['older adults', 'hypertensive old adults', 'Thirty-three participants (mean age: 82\u2009±\u20099\u2009years', 'community dwelling old hypertensive adults']","['tailored physical exercise intervention program', 'physical training program', 'physical exercise', 'personalized physical exercise program']","['brachial and central blood pressure', 'peripheral and central blood pressure']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}]",33.0,0.0133744,No significant changes were observed in any of the considered endpoints in the control group.,"[{'ForeName': 'Telmo', 'Initials': 'T', 'LastName': 'Pereira', 'Affiliation': 'Polytechnic Institute of Coimbra, Coimbra Health School, LabinSaude, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Cipriano', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000460']
2378,32898357,A Solution for Homogeneous Liver Enhancement in Computed Tomography: Results From the COMpLEx Trial.,"OBJECTIVES


The aim of the study was to reach homogeneous enhancement of the liver, irrespective of total body weight (TBW) or tube voltage. An easy-to-use rule of thumb, the 10-to-10 rule, which pairs a 10 kV reduction in tube voltage with a 10% decrease in contrast media (CM) dose, was evaluated.
MATERIALS AND METHODS


A total of 256 patients scheduled for an abdominal CT in portal venous phase were randomly allocated to 1 of 4 groups. In group 1 (n = 64), a tube voltage of 120 kV and a TBW-adapted CM injection protocol was used: 0.521 g I/kg. In group 2 (n = 63), tube voltage was 90 kV and the TBW-adapted CM dosing factor remained 0.521 g I/kg. In group 3 (n = 63), tube voltage was reduced by 20 kV and CM dosing factor by 20% compared with group 1, in line with the 10-to-10 rule (100 kV; 0.417 g I/kg). In group 4 (n = 66), tube voltage was decreased by 30 kV paired with a 30% decrease in CM dosing factor compared with group 1, in line with the 10-to-10 rule (90 kV; 0.365 g I/kg). Objective image quality was evaluated by measuring attenuation in Hounsfield units (HU), signal-to-noise ratio, and contrast-to-noise ratio in the liver. Overall subjective image quality was assessed by 2 experienced readers by using a 5-point Likert scale. Two-sided P values below 0.05 were considered significant.
RESULTS


Mean attenuation values in groups 1, 3, and 4 were comparable (118.2 ± 10.0, 117.6 ± 13.9, 117.3 ± 21.6 HU, respectively), whereas attenuation in group 2 (141.0 ± 18.2 HU) was significantly higher than all other groups (P < 0.01). No significant difference in attenuation was found between weight categories 80 kg or less and greater than 80 kg within the 4 groups (P ≥ 0.371). No significant differences in subjective image quality were found (P = 0.180).
CONCLUSIONS


The proposed 10-to-10 rule is an easily reproducible method resulting in similar enhancement in portal venous CT of the liver throughout the patient population, irrespective of TBW or tube voltage.",2020,No significant difference in attenuation was found between weight categories 80 kg or less and greater than 80 kg within the 4 groups (P ≥ 0.371).,['256 patients scheduled for an abdominal CT in portal venous phase'],[],"['attenuation in Hounsfield units (HU), signal-to-noise ratio, and contrast-to-noise ratio', 'Overall subjective image quality', 'subjective image quality', 'Mean attenuation values', 'Objective image quality', 'total body weight (TBW) or tube voltage', 'tube voltage']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",[],"[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0175730', 'cui_str': 'Tube'}]",256.0,0.0264405,No significant difference in attenuation was found between weight categories 80 kg or less and greater than 80 kg within the 4 groups (P ≥ 0.371).,"[{'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Martens', 'Affiliation': 'From the *Department of Radiology and Nuclear Medicine, Maastricht University Medical Center †CARIM School for Cardiovascular Diseases, Maastricht University ‡Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center §Department of Internal Medicine, Division of Medical Oncology, GROW-School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Wildberger', 'Affiliation': ''}, {'ForeName': 'Babs M F', 'Initials': 'BMF', 'LastName': 'Hendriks', 'Affiliation': ''}, {'ForeName': 'Sander M J', 'Initials': 'SMJ', 'LastName': 'Van Kuijk', 'Affiliation': ''}, {'ForeName': 'Estelle C', 'Initials': 'EC', 'LastName': 'Nijssen', 'Affiliation': ''}, {'ForeName': 'Nicky H G M', 'Initials': 'NHGM', 'LastName': 'Peters', 'Affiliation': ''}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'De Vos-Geelen', 'Affiliation': ''}, {'ForeName': 'Casper', 'Initials': 'C', 'LastName': 'Mihl', 'Affiliation': ''}]",Investigative radiology,['10.1097/RLI.0000000000000693']
2379,32898379,"Cooled Radiofrequency Ablation Compared with a Single Injection of Hyaluronic Acid for Chronic Knee Pain: A Multicenter, Randomized Clinical Trial Demonstrating Greater Efficacy and Equivalent Safety for Cooled Radiofrequency Ablation.","BACKGROUND


Knee osteoarthritis is a painful and sometimes debilitating disease that often affects patients for years. Current treatments include short-lasting and often repetitive nonsurgical options, followed by surgical intervention for appropriate candidates. Cooled radiofrequency ablation (CRFA) is a minimally invasive procedure for the treatment of pain related to knee osteoarthritis. This trial compared the efficacy and safety of CRFA with those of a single hyaluronic acid (HA) injection.
METHODS


Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities were screened for enrollment in this multicenter, randomized trial. One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief were randomized to receive either CRFA on 4 genicular nerves or a single HA injection. One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA). Evaluations for pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety were performed at 1, 3, and 6 months after treatment.
RESULTS


Demographic characteristics did not differ significantly between the 2 study groups. A total of 158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up. In the CRFA group, 71% of the subjects had ≥50% reduction in the NRS pain score (primary end point) compared with 38% in the HA group (p < 0.0001). At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001). The mean WOMAC score improvement at 6 months from baseline was 48.2% in the CRFA group and 22.6% in the HA group (p < 0.0001). At 6 months, 72% of the subjects in the CRFA group reported improvement in the GPE score compared with 40% in the HA group (p < 0.0001).
CONCLUSIONS


CRFA-treated subjects demonstrated a significant improvement in pain relief and overall function compared with subjects treated with a single injection of HA. No serious adverse events related to either procedure were noted, and the overall adverse-event profiles were similar.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001).","['Two hundred and sixty subjects with knee osteoarthritis pain that was inadequately responsive to prior nonoperative modalities', 'Chronic Knee Pain', 'One hundred and seventy-five subjects were treated (88 with CRFA and 87 with HA', 'One hundred and eighty-two subjects who met the inclusion criteria underwent diagnostic block injections and those with a minimum of 50% pain relief', '158 subjects (76 in the CRFA group and 82 in the HA group) completed the 6-month post-treatment follow-up']","['single hyaluronic acid (HA) injection', 'CRFA', 'Hyaluronic Acid', 'Cooled radiofrequency ablation (CRFA', 'CRFA on 4 genicular nerves or a single HA injection', 'Cooled Radiofrequency Ablation']","['NRS pain score', 'mean NRS score reduction', 'GPE score', 'efficacy and safety', 'pain (Numeric Rating Scale [NRS]), function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), quality of life (Global Perceived Effect [GPE] score and EuroQol-5 Dimensions-5 Level [EQ-5D-5L] questionnaire), and safety', 'pain relief and overall function', 'mean WOMAC score improvement']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",182.0,0.11428,"At 6 months, the mean NRS score reduction was 4.1 ± 2.2 for the CRFA group compared with 2.5 ± 2.5 for the HA group (p < 0.0001).","[{'ForeName': 'Antonia F', 'Initials': 'AF', 'LastName': 'Chen', 'Affiliation': ""1Brigham and Women's Hospital, Boston, Massachusetts 2University Orthopedics Center, Altoona, Pennsylvania 3University Orthopedics Center, State College, Pennsylvania 4Virginia iSpine Physicians, Richmond, Virginia 5University of Virginia, Charlottesville, Virginia 6Ochsner Clinic Foundation, New Orleans, Louisiana 7Clinical Investigations, LLC, Edmond, Oklahoma 8Piedmont Comprehensive Pain Management Group (PCPMG), Greenville, South Carolina 9Mayo Clinic, Rochester, Minnesota 10University of Pennsylvania, Philadelphia, Pennsylvania 11Institute for Orthopedic Research and Innovation, Coeur d'Alene, Idaho.""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Khalouf', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Zora', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DePalma', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Kohan', 'Affiliation': ''}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Guirguis', 'Affiliation': ''}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Beall', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Loudermilk', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Pingree', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Badiola', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Lyman', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00935']
2380,30719645,"Associations Between Polypharmacy, Symptom Burden, and Quality of Life in Patients with Advanced, Life-Limiting Illness.","BACKGROUND


Polypharmacy may be particularly burdensome near the end of life, as patients ""accumulate"" medications to treat and prevent multiple diseases.
OBJECTIVE


To evaluate associations between polypharmacy, symptom burden, and quality of life (QOL) in patients with advanced, life-limiting illness (clinician-estimated, 1 month-1 year).
DESIGN


Secondary analysis of baseline data from a trial of statin discontinuation.
PARTICIPANTS


Adults with advanced, life-limiting illness.
MAIN MEASURES


Polypharmacy was assessed by summing the number of non-statin medications taken regularly or as needed. Symptom burden was assessed using the Edmonton Symptom Assessment Scale (range 0-90; higher scores indicating greater symptom burden) and QOL was assessed using the McGill QOL Questionnaire (range 0-10; higher scores indicating better QOL). Linear regression models assessed associations between polypharmacy, symptom burden, and QOL.
KEY RESULTS


Among 372 participants, 47% were age 75 or older and 35% were enrolled in hospice. The mean symptom score was 27.0 (standard deviation (SD) 16.1) and the mean QOL score was 7.0 (SD 1.3). The average number of non-statin medications was 11.6 (SD 5.0); one-third of participants took ≥ 14 medications. In adjusted models, higher polypharmacy was associated with higher symptom burden (coefficient 0.81; p < .001) and lower QOL (coefficient - .06; p = .001). Adjusting for symptom burden weakened the association between polypharmacy and QOL (coefficient - .03; p = .045) without a significant interaction, suggesting that worse quality of life associated with polypharmacy may be related to medication-associated symptoms.
CONCLUSIONS


Among adults with advanced illness, taking more medications is associated with higher symptom burden and lower QOL. Attention to medication-related symptoms and shared decision-making regarding deprescribing are warranted in this setting.
NIH TRIAL REGISTRY NUMBER


ClinicalTrials.gov Identifier for Parent Study - NCT01415934.",2019,"Adjusting for symptom burden weakened the association between polypharmacy and QOL (coefficient - .03; p = .045) without a significant interaction, suggesting that worse quality of life associated with polypharmacy may be related to medication-associated symptoms.
","['372 participants, 47% were age 75 or older and 35% were enrolled in hospice', 'Patients with Advanced, Life-Limiting Illness', 'Adults with advanced, life-limiting illness', 'patients with advanced, life-limiting illness (clinician-estimated, 1\xa0month-1\xa0year', 'adults with advanced illness']",[],"['number of non-statin medications taken regularly or as needed', 'average number of non-statin medications', 'Symptom burden', 'Edmonton Symptom Assessment Scale', 'McGill QOL Questionnaire', 'polypharmacy, symptom burden, and QOL', 'mean symptom score', 'Polypharmacy, Symptom Burden, and Quality of Life', 'lower QOL', 'polypharmacy, symptom burden, and quality of life (QOL', 'mean QOL score']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",372.0,0.156937,"Adjusting for symptom burden weakened the association between polypharmacy and QOL (coefficient - .03; p = .045) without a significant interaction, suggesting that worse quality of life associated with polypharmacy may be related to medication-associated symptoms.
","[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA. yas28@pitt.edu.'}, {'ForeName': 'Seo Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Center for Research on Healthcare Data Center, Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Kwonho', 'Initials': 'K', 'LastName': 'Jeong', 'Affiliation': 'Center for Research on Healthcare Data Center, Division of General Internal Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pruskowski', 'Affiliation': 'Department of Pharmacy and Therapeutics, UPMC Palliative and Supportive Institute, University of Pittsburgh School of Pharmacy, Pittsburgh, PA, USA.'}, {'ForeName': 'Dio', 'Initials': 'D', 'LastName': 'Kavalieratos', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Resick', 'Affiliation': 'Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Suite 600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Abernethy', 'Affiliation': 'Flatiron Health, NY, New York City, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04837-7']
2381,30871785,Meditation focused on self-observation of the body impairs metacognitive efficiency.,"In the last decade of research on metacognition, the literature has been focused on understanding its mechanism, function and scope; however, little is known about whether metacognitive capacity can be trained. The specificity of the potential training procedure is in particular still largely unknown. In this study, we evaluate whether metacognition is trainable through generic meditation training, and if so, which component of meditation would be instrumental in this improvement. To this end, we evaluated participants' metacognitive efficiency before and after two types of meditation training protocols: the first focused on mental cues (Mental Monitoring [MM] training), whereas the second focused on body cues (Self-observation of the Body [SoB] training). Results indicated that while metacognitive efficiency was stable in MM training group, it was significantly reduced in the SoB group after training. This suggests that metacognition should not be conceived as a stable capacity but rather as a malleable skill.",2019,"Results indicated that while metacognitive efficiency was stable in MM training group, it was significantly reduced in the SoB group after training.",[],"['meditation training protocols: the first focused on mental cues (Mental Monitoring [MM] training), whereas the second focused on body cues (Self-observation of the Body [SoB] training']",['metacognitive efficiency'],[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}]",,0.0128041,"Results indicated that while metacognitive efficiency was stable in MM training group, it was significantly reduced in the SoB group after training.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Escuela de Psicología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile; Instituto Milenio para la Investigación en Depresión y Personalidad (MIDAP), Santiago, Chile. Electronic address: vicenteschmidt@gmail.com.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Reyes', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo, Santiago, Chile. Electronic address: gabrielreyes@udd.cl.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Barrientos', 'Affiliation': 'Facultad de Psicología, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Álvaro I', 'Initials': 'ÁI', 'LastName': 'Langer', 'Affiliation': 'Escuela de Psicología, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile; Instituto Milenio para la Investigación en Depresión y Personalidad (MIDAP), Santiago, Chile; Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (IMHAY), Santiago, Chile; Center for Interdisciplinary Studies on the Nervous System (CISNe), Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Sackur', 'Affiliation': 'École des Hautes Études en Sciences Sociales (EHESS), Paris, France; Subjective Correlates of Cognitive Mechanisms Group (EHESS/CNRS/ENS), PSL Research University, Paris, France; École Polytechnique, Palaiseau, France.'}]",Consciousness and cognition,['10.1016/j.concog.2019.03.001']
2382,31864960,Audio-visual priming in 7-month-old infants: An ERP study.,"The current study investigates categorical priming across modalities in 7-month-old infants using electroencephalographic (EEG) measures. In two experiments, infants were presented with sounds as primes, followed by images of human figures and furniture items as targets. In experiment 1 (N = 20), images were preceded by infant-directed (ID) or adult-directed (AD) speech to explore effects of intermodal categorical mismatches. Furniture targets (mismatching category) elicited an increased amplitude of the Negative central (Nc) component compared to human targets (matching category), p < .01, indicating increased attention. Results did not vary with manner of speaking (ID or AD). Experiment 2 (N = 17) explored whether a categorical mismatch between prime and target would elicit increased positive slow wave (PSW) amplitudes for human targets, indicating increased memory effort. Here, bicycle ringtones and ID speech served as primes. Again, furniture targets elicited an increased Nc regardless of prime category, p < .05, and a categorical change from human speech to furniture target images elicited an increased PSW, p < .05. No PSW effect was found for human targets following bicycle ringtones, however. The experiments reported here suggest that auditory primes may increase infant attention and memory updating particularly for non-social, categorically mismatching stimuli.",2020,"Again, furniture targets elicited an increased Nc regardless of prime category, p < .05, and a categorical change from human speech to furniture target images elicited an increased PSW, p < .05.","['7-month-old infants using electroencephalographic (EEG) measures', '7-month-old infants']",[],"['positive slow wave (PSW) amplitudes', 'amplitude of the Negative central (Nc) component']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0254234,"Again, furniture targets elicited an increased Nc regardless of prime category, p < .05, and a categorical change from human speech to furniture target images elicited an increased PSW, p < .05.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Peykarjou', 'Affiliation': 'Department of Psychology, Heidelberg University, Heidelberg, Germany. Electronic address: stefanie.peykarjou@psychologie.uni-heidelberg.de.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wissner', 'Affiliation': 'Department of Psychology, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Pauen', 'Affiliation': 'Department of Psychology, Heidelberg University, Heidelberg, Germany.'}]",Infant behavior & development,['10.1016/j.infbeh.2019.101411']
2383,31958547,Becoming sexy: Contrapposto pose increases attractiveness ratings and modulates observers' brain activity.,"Previous neurophysiological studies have revealed the neural correlates of human body form perception, as well as those related to the perception of attractive body sizes. In the current study we aimed to extend the neurophysiological studies regarding body perception by investigating the perception of human body posture to provide insights into the cognitive mechanisms responsive to bodily form, and the processing of its attractiveness. To achieve these aims, we used the contrapposto posture which creates an exaggeration of low waist to hip ratio (WHR), an indicator of women's attractiveness. Electroencephalogram (EEG) signals were recorded while participants completed both (i) an oddball task presenting female body forms differing in pose (contrapposto vs. standing) and viewing angle (anterior vs. posterior), and (ii) a subsequent active attractiveness judgement task. Behavioral results showed that a contrapposto pose is considered more attractive than a neutral standing pose. Results at the neural level showed that body posture modulates the visual information processing in early ERP components, indicating attentional variations depending on human body posture; as well as in late components, indicating further differences in attention and attractiveness judgement of stimuli varying in body pose. Furthermore, the LORETA results identified the middle temporal gyrus as well as angular gyrus as the key brain regions activated in association with the perception and attractiveness judgment of females' bodies with different body poses. Overall, the current paper suggests the evolutionary adaptive preference for lower WHRs as in the contrapposto pose activating brain regions associated with visual perception and attractiveness judgement.",2020,"Results at the neural level showed that body posture modulates the visual information processing in early ERP components, indicating attentional variations depending on human body posture; as well as in late components, indicating further differences in attention and attractiveness judgement of stimuli varying in body pose.",[],[],"['Electroencephalogram (EEG) signals', 'attractiveness ratings']",[],[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",,0.0182527,"Results at the neural level showed that body posture modulates the visual information processing in early ERP components, indicating attentional variations depending on human body posture; as well as in late components, indicating further differences in attention and attractiveness judgement of stimuli varying in body pose.","[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Pazhoohi', 'Affiliation': 'Department of Psychology, University of British Columbia, 2136 West Mall, Vancouver, British Columbia, V6T 1Z4, Canada. Electronic address: pazhoohi@gmail.com.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Arantes', 'Affiliation': 'Department of Basic Psychology, School of Psychology, University of Minho, Braga, Portugal.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kingstone', 'Affiliation': 'Department of Psychology, University of British Columbia, 2136 West Mall, Vancouver, British Columbia, V6T 1Z4, Canada.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Pinal', 'Affiliation': 'Psychological Neuroscience Lab, CIPsi, School of Psychology, University of Minho, Braga, Portugal. Electronic address: diego.pinal.fdez@gmail.com.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107842']
2384,31958548,Sympathetic contributions to habituation and recovery of the cardiac defense response.,"The cardiac defense response (CDR) to intense auditory stimulation is characterized by two acceleration-deceleration heart rate (HR) components. This study investigated contributions of sympathetic cardiac control to habituation and recovery of the CDR. Fifty-six healthy subjects were presented with noise stimuli eliciting the CDR. Three stimuli were presented with short and long (2.5 min and 12.5 min) inter-trial intervals (ITIs). The pre-ejection period was recorded as an index of sympathetic cardiac control, in addition to HR. Repeated stimulation at short ITI was associated with marked habituation of the HR and sympathetic responses; both responses exhibited a degree of recovery with long ITI. Regarding the time course, the first acceleration-deceleration was accompanied by a decline and subsequent increase in sympathetic cardiac control. During the second acceleration-deceleration, the parameters exhibited parallel courses. These results suggest that the sympathetic contribution to the habituation and recovery is limited to the second HR component.",2020,Repeated stimulation at short ITI was associated with marked habituation of the HR and sympathetic responses; both responses exhibited a degree of recovery with long ITI.,['Fifty-six healthy subjects'],[],"['noise stimuli eliciting the CDR', 'sympathetic cardiac control', 'marked habituation of the HR and sympathetic responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",56.0,0.0209684,Repeated stimulation at short ITI was associated with marked habituation of the HR and sympathetic responses; both responses exhibited a degree of recovery with long ITI.,"[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Garrido', 'Affiliation': 'Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain. Electronic address: albagarrido@ugr.es.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Duschek', 'Affiliation': 'UMIT - University of Health Sciences Medical Informatics and Technology, Hall in Tirol, Austria.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Rodríguez Árbol', 'Affiliation': 'Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}, {'ForeName': 'Isis', 'Initials': 'I', 'LastName': 'González Usera', 'Affiliation': 'Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Vila', 'Affiliation': 'Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Mata', 'Affiliation': 'Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107846']
2385,31958549,Sex differences in emotional concordance.,"Emotions involve response synchronization across experiential, physiological, and behavioral systems, referred to as concordance or coherence. Women are thought to be more emotionally aware and expressive than men and may therefore display stronger response concordance; however, research on this topic is scant. Using a random-order film-average design, we assessed concordance among experiential (arousal, valence), autonomic (electrodermal activity, heart rate, preejection period, respiratory sinus arrhythmia), respiratory (respiratory rate), and behavioral (corrugator and zygomatic electromyography) responses to 15 two-minute films varying in valence and arousal. We then calculated for each participant and pair of measures a within-subject correlation index using averages from the 15 films. Pronounced individual concordance of up to 0.9 was observed. Arousal-physiology and valence-behavior concordances were particularly pronounced. Women displayed higher concordance than men for almost all pairs of measures. Findings indicate stronger psychophysiological response coupling in women than men and provide novel insights into affective differences between the sexes.",2020,Women displayed higher concordance than men for almost all pairs of measures.,[],[],"['Arousal-physiology and valence-behavior concordances', 'experiential (arousal, valence), autonomic (electrodermal activity, heart rate, preejection period, respiratory sinus arrhythmia), respiratory (respiratory rate), and behavioral (corrugator and zygomatic electromyography) responses']",[],[],"[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",,0.0253163,Women displayed higher concordance than men for almost all pairs of measures.,"[{'ForeName': 'Julina A', 'Initials': 'JA', 'LastName': 'Rattel', 'Affiliation': 'Clinical Stress and Emotion Laboratory, Division of Clinical Psychology, Psychotherapy, and Health Psychology, Department of Psychology, University of Salzburg, Austria. Electronic address: julina.rattel@sbg.ac.at.'}, {'ForeName': 'Iris B', 'Initials': 'IB', 'LastName': 'Mauss', 'Affiliation': 'Department of Psychology, University of California, Berkeley, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liedlgruber', 'Affiliation': 'Clinical Stress and Emotion Laboratory, Division of Clinical Psychology, Psychotherapy, and Health Psychology, Department of Psychology, University of Salzburg, Austria.'}, {'ForeName': 'Frank H', 'Initials': 'FH', 'LastName': 'Wilhelm', 'Affiliation': 'Clinical Stress and Emotion Laboratory, Division of Clinical Psychology, Psychotherapy, and Health Psychology, Department of Psychology, University of Salzburg, Austria.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107845']
2386,31981584,Electroencephalographic evidence for a reinforcement learning advantage during motor skill acquisition.,"The feedback that we receive shapes how we learn. Previous research has demonstrated that quantitative feedback results in better performance than qualitative feedback. However, the data supporting a quantitative feedback advantage are not conclusive and further little work has been done to examine the mechanistic neural differences that underlie the relative benefits of quantitative and qualitative feedback. To address these issues, participants learned a simple motor task in quantitative and qualitative feedback conditions while electroencephalographic (EEG) data were recorded. We found that participants were more accurate and had a larger neural response - the feedback related negativity - when qualitative feedback was provided. Our data suggest that qualitative feedback is more advantageous than quantitative feedback during the early stages of skill acquisition. Additionally, our findings support previous work suggesting that a reinforcement learning system within the human medial-frontal cortex plays a key role in motor skill acquisition.",2020,We found that participants were more accurate and had a larger neural response - the feedback related negativity - when qualitative feedback was provided.,[],[],[],[],[],[],,0.0293913,We found that participants were more accurate and had a larger neural response - the feedback related negativity - when qualitative feedback was provided.,"[{'ForeName': 'Francisco L', 'Initials': 'FL', 'LastName': 'Colino', 'Affiliation': 'Centre for Biomedical Research, University of Victoria, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Heath', 'Affiliation': 'School of Kinesiology and Program in Neuroscience, University of Western Ontario, Canada.'}, {'ForeName': 'Cameron D', 'Initials': 'CD', 'LastName': 'Hassall', 'Affiliation': 'Centre for Biomedical Research, University of Victoria, Canada.'}, {'ForeName': 'Olave E', 'Initials': 'OE', 'LastName': 'Krigolson', 'Affiliation': 'Centre for Biomedical Research, University of Victoria, Canada. Electronic address: krigolson@uvic.ca.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107849']
2387,32913797,Psychological and physiological effects of emotion focused training for self-compassion and self-protection.,"Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP) is a novel intervention developed on the basis of the latest findings on self-criticism from Emotion-focused therapy and existing programs designed to cultivate compassion. EFTSCP is designed to encourage participants to cultivate self-compassion and protective anger as a way of reducing selfcriticism. Our goal was to investigate the effect of this group-based intervention on self-criticism, self-protection, and self-compassion. A total of 73 students were assigned to the EFT-SCP intervention ( n =19), no-treatment control ( n =34) or to an active control group ( n =20). The intervention group met weekly for 1.5 hours and were instructed to incorporate EFT-SCP tasks into their daily life for 12 weeks. Whilst the no-treatment group did not undergo an intervention, the active control group completed an adapted expressive writing task once a week. In addition to the assessment of heart rate variability during imagery tasks, participants also completed self-reported measures of self-compassion and self-criticism before and after the intervention. Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017; .34 and Inadequate Self P<.001; .33) and self-uncompassionate responding (P<.001; .39). All three effect sizes were small. Participating in EFT-SCP had a positive effect on psychological and physiological outcomes.",2019,"Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017;",['A total of 73 students'],"['EFT-SCP intervention', 'EFTSCP', 'EFT-SCP tasks', 'Emotion Focused Training for Self-Compassion and Self-Protection (EFT-SCP']","['selfcriticism', 'self-criticism, self-protection, and self-compassion', 'self-compassion and self-criticism', 'heart rate variability', 'heart rate variability following EFT-SCP']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",73.0,0.0216659,"Compared with both control groups, the intervention group showed a significant increase in heart rate variability following EFT-SCP (during self-critical imagery, P=.049; probability of superiority was .63, and during self-compassionate imagery P=.007; probability of superiority was .62, both effect sizes were medium) and significant decreases in selfcriticism (Hated Self P=.017;","[{'ForeName': 'Júlia', 'Initials': 'J', 'LastName': 'Halamová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Koróniová', 'Affiliation': 'Institute of Applied Psychology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kanovský', 'Affiliation': 'Institute of Social Anthropology, Faculty of Social and Economic Sciences, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Mária Kénesy', 'Initials': 'MK', 'LastName': 'Túniyová', 'Affiliation': 'Institute of Experimental Psychology, Center of Social and Psychological Sciences, Slovak Academy of Sciences, Bratislava, Slovakia.'}, {'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Kupeli', 'Affiliation': 'Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, United Kingdom.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.358']
2388,32913807,Reductions in transdiagnostic factors as the potential mechanisms of change in treatment outcomes in the Unified Protocol: a randomized clinical trial.,"Transdiagnostic approaches emphasize on the share underlying features of emotional disorders. In their view, these transdiagnostic factors play an important role in the etiology, maintenance, and treatment of emotional disorders. This study aimed to investigate the transdiagnostic factors as the potential mechanisms of change in the Unified Protocol (UP) for the transdiagnostic treatment of emotional disorders outcomes. The present study is a randomized clinical trial. Twenty-six individuals were selected based on the Beck anxiety inventory and Beck depression inventory and randomly assigned into two groups of control and treatment (n=13). The treatment group received 20 one-hour individual UP sessions. Beck Depression Inventory, Beck Anxiety Inventory, Difficulty in emotion regulation scale, Intolerance of Uncertainty scale and Acceptance and Action questionnaire were carried out in all three phases. UP enhances the difficulty in emotion regulation (large effect size, SEsg=1.81), intolerance of uncertainty (SEsg=1.91), and experiential avoidance (SEsg=1.78). In addition, the results of linear regression show the association between changes in anxiety and depression with changes in transdiagnostic factors. The difficulty in emotion regulation, intolerance of uncertainty and experiential avoidance can be considered as the potential mechanism of change in improving UP outcomes.",2019,"UP enhances the difficulty in emotion regulation (large effect size, SEsg=1.81), intolerance of uncertainty (SEsg=1.91), and experiential avoidance (SEsg=1.78).",['Twenty-six individuals were selected based on the Beck anxiety inventory and Beck depression inventory and randomly assigned into two groups of control and treatment (n=13'],['20 one-hour individual UP sessions'],"['Beck Depression Inventory, Beck Anxiety Inventory, Difficulty in emotion regulation scale, Intolerance of Uncertainty scale and Acceptance and Action questionnaire', 'difficulty in emotion regulation']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",26.0,0.021658,"UP enhances the difficulty in emotion regulation (large effect size, SEsg=1.81), intolerance of uncertainty (SEsg=1.91), and experiential avoidance (SEsg=1.78).","[{'ForeName': 'Sahel', 'Initials': 'S', 'LastName': 'Khakpoor', 'Affiliation': 'Master of Clinical Psychology, Education and Treatment Center of Beheshti Hospital, Zanjan University of Medical Sciences, Zanjan.'}, {'ForeName': 'Jahangir', 'Initials': 'J', 'LastName': 'Mohammadi Bytamar', 'Affiliation': 'Master of Clinical Psychology, Education and Treatment Center of Valiasr Hospital, Zanjan University of Medical Sciences, Zanjan.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Saed', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.379']
2389,32890575,"A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial.","BACKGROUND


Allergic rhinitis (AR) induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies.
OBJECTIVE


To assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged ≥12) and adults with moderate-to-severe HDM-induced AR.
METHODS


In a Phase III, international, double-blind, placebo-controlled, randomized clinical trial, participants received approximately 12 months of treatment with placebo or the 300°IR tablet. The primary endpoint was the average total combined score (aTCS) during 4 weeks at the end of the treatment period.
RESULTS


1,607 participants were randomized, and 1,476 (including 555 (37.6%) with concomitant mild controlled asthma at inclusion) comprised the full analysis set. Over the primary evaluation period, the least squares mean aTCS in the 300°IR group (3.62) was significantly lower (p<0.0001) than in the placebo group (4.35), with a relative least squares mean difference of -16.9% [95% confidence interval: -24.0%; -9.2%]. All pre-specified secondary endpoints were consistently improved in the 300°IR group, relative to placebo. The 300°IR tablet was generally well tolerated. Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
CONCLUSIONS


The 300°IR sublingual HDM tablet is an effective, safe treatment for HDM-induced AR. (NCT02443805, EudraCT 2014-004223-46) CLINICAL IMPLICATIONS: A 300 index of reactivity sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae extract is a safe, effective treatment for moderate-to-severe house-dust-mite-induced allergic rhinitis.",2020,"Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
","['adolescents (aged ≥12) and adults with moderate-to-severe HDM-induced AR', '1,607 participants were randomized, and 1,476 (including 555 (37.6%) with concomitant mild controlled asthma at inclusion', 'moderate-to-severe house-dust-mite-induced allergic rhinitis', 'house-dust-mite-induced allergic rhinitis']","['placebo', 'Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract', 'Dermatophagoides pteronyssinus:Dermatophagoides farinae extract']","['least squares mean aTCS', 'average total combined score (aTCS', 'efficacy and safety', 'adverse events', 'tolerated', 'sleep, work, leisure activities, and health-related quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0323674', 'cui_str': 'Dermatophagoides'}, {'cui': 'C0323677', 'cui_str': 'Dermatophagoides farinae'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1445449', 'cui_str': 'Dermatophagoides farinae diagnostic allergen extract'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",1607.0,0.257438,"Treatment-related adverse events (mainly mild or moderate local reactions) were reported for 51.0% of the patients in the 300°IR group and 14.9% in the placebo group.
","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Demoly', 'Affiliation': 'Department of Pulmonology and Addictology, Arnaud de Villeneuve Hospital, Montpellier University, Montpellier, France; Sorbonne Université, UMR-S 1136 INSERM, IPLESP, EPAR Team, Paris, France. Electronic address: pascal.demoly@inserm.fr.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Departments of Medicine and Pediatrics, David Geffen School of Medicine at the University of California, Los Angeles, California, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Creticos', 'Affiliation': 'Division of Allergy & Clinical Immunology, Johns Hopkins Medicine, Baltimore, Maryland, United States; Creticos Research Group with Charleston Allergy & Asthma, Charleston, South Carolina, United States.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'De Blay', 'Affiliation': 'Allergy Division, Chest Diseases Department, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gevaert', 'Affiliation': 'Upper Airways Research Laboratory, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hellings', 'Affiliation': 'Department of Otorhinolaryngology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kowal', 'Affiliation': 'Department of Experimental Allergology and Immunology, Medical University of Bialystok, Bialystok, Poland.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Le Gall', 'Affiliation': 'Global Clinical Development Department, Stallergenes Greer, Antony, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nenasheva', 'Affiliation': 'Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Passalacqua', 'Affiliation': 'Allergy and Respiratory Diseases, IRCCS Policlinico S.Martino, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pfaar', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Tortajada-Girbés', 'Affiliation': 'Pediatric Pulmonology and Allergy Unit, Department of Pediatrics, Dr. Peset University Hospital, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology. University of Valencia, Valencia, Spain; IVI Foundation, Valencia, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': 'Allergy Department, Complejo Hospitalario Universitario de Santiago, Faculty of Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Department of Dermatology, Allergy and Venerology, Charité, Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Casale', 'Affiliation': 'Division of Allergy and Immunology, University of South Florida, Tampa, FL, United States.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.07.036']
2390,32890647,Fusion imaging with a mobile C-arm for peripheral arterial disease.,"OBJECTIVES


Fusion imaging makes it possible to improve endovascular procedures and is mainly used in hybrid rooms for aortic procedures. The objective of this study was to evaluate the feasibility of fusion imaging for femoro-popliteal endovascular procedures with a mobile flat plane sensor and dedicated software to assist endovascular navigation.
MATERIAL AND METHODS


Between May and December 2017, 41 patients requiring femoro-popliteal endovascular revascularization were included. Interventions were carried out in a conventional surgical room equipped with a mobile plane sensor (Cios Alpha, Siemens). The numerical video stream was transmitted to an angionavigation station (EndoNaut (EN), Therenva). The software created an osseous and arterial panorama of the treated limb from the angiographies carried out at the beginning of procedure. After each displacement of the table, the software relocated the current image on the osseous panorama, with 2D-2D resetting, and amalgamated the mask of the arterial panorama. The success rates of creation of osseous and arterial panorama and the success of relocation were evaluated. The data concerning irradiation, the volume of contrast injected, and operative times were recorded.
RESULTS


Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%). 35 relocations based on a 2D-2D resetting could be obtained in the 41 procedures, with a success rate of 85%. The causes of failure were a change in table height or arch angulation. The average duration of intervention was 74.5 min. The irradiation parameters were: duration of fluoroscopy 17.8 ± 13.1 min, K a  80.5 ± 68.4 mGy, DAP 2140±1599 μGy.m 2 . The average volume of contrast (VC) was 24.5 ± 14 mL.
CONCLUSIONS


This preliminary study showed that fusion imaging is possible in a non-hybrid room for peripheral procedures. Imagery of mobile C-arms can be improved for femoro-popliteal endovascular procedures without heavy equipment. These imagery tools bring an operative comfort and could probably reduce irradiation and the injected volume of contrast. The clinical benefit must be evaluated in more patients in a randomized comparative study with a rigorous methodology.",2020,"RESULTS


Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%).",['41 patients requiring femoro-popliteal endovascular revascularization were included'],[],"['average volume of contrast (VC', 'success rates of creation of osseous and arterial panorama and the success of relocation', 'average duration of intervention']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0338013,"RESULTS


Osseous panoramas could be automatically generated for the 41 procedures, without manual adjustment in 33 cases (80.5%).","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Villena', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, F-35033, Rennes, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Lalys', 'Affiliation': 'Therenva, F-35000, Rennes, France.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Saudreau', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, F-35033, Rennes, France.'}, {'ForeName': 'Rémy', 'Initials': 'R', 'LastName': 'Pascot', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, F-35033, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Barré', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, F-35033, Rennes, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lucas', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, F-35033, Rennes, France; INSERM, U1099, F-35000 Rennes, France; Signal and Image Processing Laboratory (LTSI), University of Rennes 1 F-35000 Rennes, France.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Kaladji', 'Affiliation': 'Center of cardiothoracic and vascular surgery, Rennes University Hospital, F-35033, Rennes, France; INSERM, U1099, F-35000 Rennes, France; Signal and Image Processing Laboratory (LTSI), University of Rennes 1 F-35000 Rennes, France. Electronic address: adrien.kaladji@chu-rennes.fr.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.07.059']
2391,32890770,Effectiveness of a home-based exercise program among patients with lower limb spasticity post-stroke: A randomised controlled trial.,"PURPOSE


To evaluate the effectiveness of advanced practice nurse (APRN)-guided home-based rehabilitation exercise program (HREPro) among patients with lower limb spasticity post-stroke.
METHODS


This randomized controlled study recruited 121 patients with lower limb spasticity post-stroke. Intervention (n=59) and control (n=62) groups underwent 12-month HREPro and conventional rehabilitation, respectively, after discharge. Fugl-Meyer assessment of spasticity measurement, modified Ashworth scale of motor function, 10-Meter Walk Test of walking ability, and Barthel index of activities of daily living (ADL) were evaluated at 0, 3, 6, and 12 months after discharge.
RESULTS


Significant differences were found in spasticity degree, motor function, walking ability, and ADL at 6 and 12 months after discharge between the control and intervention group. Lower limb spasticity and ADL in the intervention group were significantly improved.
CONCLUSION


HREPro is effective for rehabilitation of patients with lower limb spasticity post-stroke and has favorable home application.",2020,"RESULTS


Significant differences were found in spasticity degree, motor function, walking ability, and ADL at 6 and 12 months after discharge between the control and intervention group.","['patients with lower limb spasticity post-stroke', '121 patients with lower limb spasticity post-stroke']","['HREPro', 'home-based exercise program', 'advanced practice nurse (APRN)-guided home-based rehabilitation exercise program (HREPro', 'HREPro and conventional rehabilitation']","['spasticity degree, motor function, walking ability, and ADL', 'Lower limb spasticity and ADL', 'Fugl-Meyer assessment of spasticity measurement, modified Ashworth scale of motor function, 10-Meter Walk Test of walking ability, and Barthel index of activities of daily living (ADL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",121.0,0.0730015,"RESULTS


Significant differences were found in spasticity degree, motor function, walking ability, and ADL at 6 and 12 months after discharge between the control and intervention group.","[{'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Department of Rehabilitation, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.""}, {'ForeName': 'Jiaozhen', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopedics, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.""}, {'ForeName': 'Chengwei', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Department of Orthopedics, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Shui', 'Affiliation': ""Department of Orthopedics, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, the Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325035, China. Electronic address: wangyi692078@163.com.""}]",Asian nursing research,['10.1016/j.anr.2020.08.007']
2392,32890782,"Letter to the Editor Regarding: ""A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)"" - Noriega D, Marcia S, Theumann N, et al.",,2020,,[],['implantable titanium vertebral augmentation device versus balloon kyphoplasty'],[],[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]",[],,0.0122503,,"[{'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, Northside Hospital Atlanta, 1000 Johnson Ferry Rd, Atlanta GA 30342. Electronic address: sjlevy@bellsouth.net.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.08.016']
2393,32890808,Which one is favorable in the elderly? Transoral rigid laryngoscopy or transnasal flexible fiberoptic laryngoscopy.,"PURPOSE


To determine whether transoral rigid laryngeal endoscopy (TORLE) or transnasal flexible fiberoptic laryngoscopy (TNFFL) is more favorable for laryngeal endoscopic examination in the elderly population.
METHODS


This randomized prospective study carried out in a tertiary reference center. TORLE or TNFFL were performed to patients who were over 65 years at their first visit according to randomization list. At their second visit, other method was performed. Patients' physiological parameters (Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen (O 2 ) saturation before and immediately after laryngeal examination were recorded. Patients' pain-irritation, gag reflex, and dyspnea status were evaluated using visual analog scale after first and second endoscopic examinations. Further patient preferences for TORLE and TNFFL were recorded.
RESULTS


Of 96 patients included in the study, 69.8% (n = 67) preferred TORLE while 30.2% (n = 29) preferred TNFFL. Major factor influencing patient preferences was pain-irritation in TNFFL. Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001). However, no significant difference was found between two methods with respect to gag reflex and dyspnea scores (p = 0.194, p = 0.327, respectively). In TORLE, there was no statistically significant difference between the values measured before and after examination in terms of SBP, DBP, HR, and O 2  saturation (p = 0.641, p = 0.134, p = 0.119, p = 0.414, respectively). However, in TNFFL, statistically significant decrease was observed after examination in HR and O 2  saturation (p < 0.001, p < 0.001, respectively).
CONCLUSION


TORLE is more suitable for laryngeal examination in elderly patients since it is more comfortable for patient and does not change physiological parameters.",2020,Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001).,"['96 patients included in the study, 69.8% (n', 'elderly patients']","['TNFFL', 'transoral rigid laryngeal endoscopy (TORLE) or transnasal flexible fiberoptic laryngoscopy (TNFFL', 'TORLE or TNFFL', 'Transoral rigid laryngoscopy or transnasal flexible fiberoptic laryngoscopy', 'TORLE']","['visual analog scale', 'pain-irritation, gag reflex, and dyspnea status', 'Pain-irritation scores', 'gag reflex and dyspnea scores', 'examination in HR and O 2  saturation', 'SBP, DBP, HR, and O 2  saturation', 'physiological parameters (Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen (O 2 ) saturation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0702149', 'cui_str': 'Flexible fiberoptic laryngoscopy'}, {'cui': 'C0442366', 'cui_str': 'Transoral approach'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0016927', 'cui_str': 'Gagging'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",96.0,0.0255202,Pain-irritation scores were significantly higher in TNFFL than those in TORLE (p < 0.001).,"[{'ForeName': 'Kamil Gokce', 'Initials': 'KG', 'LastName': 'Tulaci', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey. Electronic address: ktulaci@gmail.com.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Tugba', 'Initials': 'T', 'LastName': 'Tulaci', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}, {'ForeName': 'Hasmet', 'Initials': 'H', 'LastName': 'Yazici', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Balikesir University, Balikesir, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102660']
2394,32890814,Did young women in South African informal settlements display increased agency after participating in the Stepping Stones and Creating Futures intervention? A qualitative evaluation.,"This paper investigates the impact of the Stepping Stones Creating Futures (SSCF) intervention on young women in informal settlements in eThekwini, South Africa. Specifically, whether following participation in the intervention the young women experienced a reduction in intimate partner violence, strengthened agency and shifted gender relations. Where changes occurred, it examines how they occurred, and barriers and enablers to change. SSCF is a gender transformative and livelihoods strengthening intervention using participatory, reflective small groups. Qualitative research was undertaken with fifteen women participating in the SSCF randomised control trial between 2015 and 2018. The women were followed over 18 months, participating in in-depth interviews at baseline, 12- and 18-months post intervention. To supplement these, eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation. Data were analysed inductively. Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods. Despite these important shifts many women did not report a reduction in IPV. Nonetheless we argue most of the women, following the intervention, became more agentic. Drawing on the notion of 'distributed agency' as developed by Campbell and Mannell (2016), we show that SSCF bolstered the women's distributed agency. Distributed agency recognizes small agentic acts that women take, acts which to them are significant, it further notes that agency is temporal, fluid, dynamic and context specific. Women do not 'either have agency or not', rather being agentic depends on time, context and the particular incident. These findings provide an important contribution to the limited application of distributed agency and femininities work in informal settlements and are critical for policy and intervention science to reduce IPV and support women's agency.",2020,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","['young women in informal settlements in eThekwini, South Africa', 'fifteen women participating in the SSCF randomised control trial between 2015 and 2018', 'eight women were involved in Photovoice work at baseline and 18 months and seven were included in ongoing participant observation']","['SSCF', 'Stepping Stones Creating Futures (SSCF) intervention']","['communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods', 'intimate partner violence, strengthened agency and shifted gender relations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0558038', 'cui_str': 'Participant observation'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242360', 'cui_str': 'Relations, Gender'}]",15.0,0.0551815,"Data revealed many women changed their behaviours following SSCF, including: having more power within relationships, improved communication and relationship skills, increased resistance to controlling partners, shifting relationship expectations, emergence of new femininities and improved livelihoods.","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Nolwazi', 'Initials': 'N', 'LastName': 'Ntini', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, Mazisi Kunene Road, University of KwaZulu-Natal, Durban, 4041, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, 1 Soutpansberg Road, Pretoria, South Africa.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113302']
2395,32890855,Reading proficiency influences the effects of transcranial direct current stimulation: Evidence from selective modulation of dorsal and ventral pathways of reading in bilinguals.,"INTRODUCTION


tDCS can modulate reading which is processed by lexical (ventral) and sub-lexical (dorsal) pathways. Previous research indicates that pathway recruitment in bilinguals depends on a script's orthographic depth and a reader's proficiency with it. The effect of tDCS on each reading pathway has not been investigated in bilinguals. We stimulated the left dorsal and ventral pathways separately in Chinese-English (C-E) bilinguals to understand whether pathway-specific modulation by tDCS is possible and, if so, how it is influenced by orthographic depth and script proficiency.
METHODS


A double-blind, sham-controlled, within-subject experiment was designed wherein 16 balanced bilinguals received anodal tDCS in dorsal, ventral and sham sessions. Two tDCS montages of electrode sizes 5 × 5 cm 2  with 1) anode at CP5 and cathode at CZ, and 2) anode at TP7 and cathode at nape of the neck, were applied for stimulating the dorsal and ventral pathways respectively. Bilinguals were asked to read word lists for each language before and after stimulation. RTs for accurate trials were analysed using linear mixed-effect modelling that included proficiency scores for reading English pseudo-words (PW) and Chinese pinyin.
RESULTS


For both languages, word reading RTs were faster following dorsal pathway stimulation. The dorsal stimulation effect (change in RT) was negatively correlated with pseudoword reading and pinyin proficiency. Stimulation of the ventral pathway decreased RTs only for Chinese reading.
CONCLUSION


Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading. Dorsal pathway tDCS effects are modulated by sub-lexical reading proficiency.",2020,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,[],"['anodal tDCS', 'tDCS']",['dorsal stimulation effect (change in RT'],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0476543,Dorsal and ventral reading pathways can be selectively modulated by tDCS in bilingual readers with dorsal (sub-lexical) pathway stimulation affecting reading in both scripts and ventral (lexical) pathway stimulation selectively affecting Chinese reading.,"[{'ForeName': 'Sagarika', 'Initials': 'S', 'LastName': 'Bhattacharjee', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Kashyap', 'Affiliation': 'Centre for Research and Development in Learning (CRADLE), Singapore.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': ""O'Brien"", 'Affiliation': 'Centre for Research in Child Development (CRCD), National Institute of Education, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCloskey', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Oishi', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Desmond', 'Affiliation': 'The Johns Hopkins University School of Medicine, Baltimore, United States.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Rapp', 'Affiliation': 'Cognitive Science, Johns Hopkins University, Baltimore, United States. Electronic address: brapp1@jhu.edu.'}, {'ForeName': 'S H Annabel', 'Initials': 'SHA', 'LastName': 'Chen', 'Affiliation': 'Psychology, School of Social Sciences, Nanyang Technological University, Singapore; Centre for Research and Development in Learning (CRADLE), Singapore; Lee Kong Chian School of Medicine (LKC Medicine), Nanyang Technological University, Singapore. Electronic address: annabelchen@ntu.edu.sg.'}]",Brain and language,['10.1016/j.bandl.2020.104850']
2396,32890862,Implementing a transdiagnostic sleep and circadian intervention in a community mental health setting: A qualitative process evaluation with community stakeholders.,"The implementation of evidence-based psychological treatments (EBPTs) may be particularly challenging to accomplish in community mental health settings for individuals with severe mental illness (SMI). Transdiagnostic treatments, or treatments that target a mechanism that underpins multiple mental health problems, may be particularly well-suited to community mental health settings. This study examines community stakeholder perspectives (N = 22) of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) implemented in a community mental health setting in the context of a randomized controlled trial of TranS-C for SMI. The present study aimed to identify barriers and facilitators to the implementation of TranS-C for SMI in a community mental health setting using (1) a deductive theory-based process based on the Framework for Dissemination in Health Services Intervention Research and (2) an inductive thematic analysis process. All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting. Seven additional themes were identified through the inductive thematic analysis. A discussion of how the findings are related to prior research, other EBPT implementation, and future TranS-C implementation are included.",2020,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,['individuals with severe mental illness (SMI'],"['Transdiagnostic Sleep and Circadian Intervention (TranS-C', 'transdiagnostic sleep and circadian intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0372757,All deductive themes were identified as both barriers and facilitators to the implementation of EBPTs and TranS-C in this community mental health setting.,"[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Gumport', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States; Department of Psychology, University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'Department of Psychology, University of California, 2121 Berkeley Way #1650, Berkeley, CA, United States. Electronic address: aharvey@berkeley.edu.'}]",Psychiatry research,['10.1016/j.psychres.2020.113443']
2397,32891074,Investigating the science attitudes of students from low socioeconomic status families: The impact of problem-based learning.,"This study aimed to examine the effect of the problem-based learning (PBL) on science attitudes of middle school students from low socio-economic status families. For this purpose, two intact classes of the same teacher were randomly assigned as experimental and control groups. In the unit of genetics, the experimental group was taught by PBL while the control group received traditional instruction. Students' attitudes were measured in terms of adoption of scientific attitudes, enjoyment of science lessons, and career interest in science administering a self-report instrument as a pre-test and a post-test. Results showed that after the treatment, although there were not statistically significant differences between two groups with respect to attitude toward science; in the experimental group, the mean scores were found to be consistently higher across all attitude dimensions compared to the control group. In addition, the mean scores suggested an improvement in the attitudes of experimental group students from pre-test to post test. Qualitative findings also revealed that students found PBL enjoyable. According to PBL students, searching for information and writing reports were among the features of the PBL contributing to their learning the most.",2020,"Results showed that after the treatment, although there were not statistically significant differences between two groups with respect to attitude toward science; in the experimental group, the mean scores were found to be consistently higher across all attitude dimensions compared to the control group.","['middle school students from low socio-economic status families', 'students from low socioeconomic status families']","['traditional instruction', 'problem-based learning (PBL']","['attitude toward science', 'adoption of scientific attitudes, enjoyment of science lessons, and career interest in science administering a self-report instrument']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.0142583,"Results showed that after the treatment, although there were not statistically significant differences between two groups with respect to attitude toward science; in the experimental group, the mean scores were found to be consistently higher across all attitude dimensions compared to the control group.","[{'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Seçgin', 'Affiliation': 'Mathematics and Science Education, Middle East Technical University, Ankara, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Sungur', 'Affiliation': 'Mathematics and Science Education, Middle East Technical University, Ankara, Turkey.'}]",Biochemistry and molecular biology education : a bimonthly publication of the International Union of Biochemistry and Molecular Biology,['10.1002/bmb.21447']
2398,32895043,Effect of Dietary Education on Cardiovascular risk Factors in Rheumatoid Arthritis Patients.,"AIM


The aim of this study was to investigate the effect of dietary education on cardiovascular risk factors in patients with rheumatoid arthritis.
METHOD


In this randomized clinical trial, 112 patients with rheumatoid arthritis were randomly assigned into two groups, intervention and control. Dietary education was provided for the intervention group in 4 sessions; anthropometric measurements, serum levels of RF, triglycerides, cholesterol, HDL, LDL, and fasting blood sugar were measured before and three months after intervention. Data was analyzed using SPSS software and appropriate statistical tests.
RESULTS


The mean of total cholesterol (p <0.001), triglycerides (p = 0.004), LDL (p <0.001), systolic blood pressure (p = 0.001), diastolic blood pressure (p = 0.003), FBS and BMI (p <0.001) were decreased significantly in the intervention group after education compared the control group.
CONCLUSION


Traditional care for rheumatoid arthritis patients is not enough. Patients need more education in order to improve their situation.",2020,"The mean of total cholesterol (p <0.001), triglycerides (p = 0.004), LDL (p <0.001), systolic blood pressure (p = 0.001), diastolic blood pressure (p = 0.003), FBS and BMI (p <0.001) were decreased significantly in the intervention group after education compared the control group.
","['rheumatoid arthritis patients', '112 patients with rheumatoid arthritis', 'patients with rheumatoid arthritis', 'Rheumatoid Arthritis Patients']","['Dietary Education', 'dietary education']","['cardiovascular risk factors', 'serum levels of RF, triglycerides, cholesterol, HDL, LDL, and fasting blood sugar', 'FBS and BMI', 'LDL', 'mean of total cholesterol', 'diastolic blood pressure', 'systolic blood pressure', 'triglycerides', 'Cardiovascular risk Factors']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",112.0,0.0386141,"The mean of total cholesterol (p <0.001), triglycerides (p = 0.004), LDL (p <0.001), systolic blood pressure (p = 0.001), diastolic blood pressure (p = 0.003), FBS and BMI (p <0.001) were decreased significantly in the intervention group after education compared the control group.
","[{'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Taheri', 'Affiliation': 'Nursing Care Research Center in Chronic Diseases, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz. Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Molavynejad', 'Affiliation': 'Nursing Care Research Center in Chronic Diseases, School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz. Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Abedi', 'Affiliation': 'Reproductive Health Promotion Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz. Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Rajaei', 'Affiliation': 'Department of Rheumatology, Ahvaz Jundishapur University of Medical Sciences, Ahvaz. Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz. Iran.'}]",Current rheumatology reviews,['10.2174/1573397116666200907112338']
2399,32895056,"Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation.
TRIAL DESIGN


This is a single centre parallel group, superiority, randomized (1:1 allocation ratio) controlled trial.
PARTICIPANTS


All patients admitted to the Hamad Medical Corporation -ICU in Qatar for COVID-19 associated respiratory distress and in need of mechanical ventilation are screened for eligibility.
INCLUSION CRITERIA


all adult patients admitted to the ICU who test positive for COVID-19 by PCR-test and in need for mechanical ventilation are eligible for inclusion. Upon crossing the limit of D-dimers (1.2 mg/L) these patients are routinely treated with an increased dose of anticoagulant according to our local protocol. This will be the start of randomization.
EXCLUSION CRITERIA


pregnancy, allergic to the drug, inherited coagulation abnormalities, no informed consent.
INTERVENTION AND COMPARATOR


The intervention group will receive the anticoagulant bivalirudin intravenously with a target aPTT of 45-70 sec for three days while the control group will stay on the standard treatment with low-molecular-weight heparins /unfractionated heparin subcutaneously (see scheme in Additional file 1). All other treatment will be unchanged and left to the attending physicians.
MAIN OUTCOMES


As a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F) ratio.
RANDOMISATION


After inclusion, the patients will be randomized using a closed envelope method into the conventional treatment group, which uses the standard strategy and the experimental group which receives anticoagulation treatment with bivalirudin using an allocation ratio of 1:1.
BLINDING (MASKING)


Due to logistical and safety reasons (assessment of aPTT to titrate the study drug) only the data-analyst will be blinded to the groups.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


We performed a sample size calculation and assumed the data for P/F ratio (according to literature) is normally distributed and used the mean which would be: 160 and SD is 80. We expect the treatment will improve this by 30%. In order to reach a power of 80% we would need 44 patients per group (in total 88 patients). Taking approximately 10% of dropout into account we will include 100 patients (50 in each group).
TRIAL STATUS


The local registration number is MRC-05-082 with the protocol version number 2. The date of approval is 18th June 2020. Recruitment started on 28 th  June and is expected to end in November 2020.
TRIAL REGISTRATION


The protocol is registered before starting subject recruitment under the title: ""Anticoagulation in patients suffering from COVID-19 disease. The ANTI-CO Trial"" in ClinicalTrials.org with the registration number: NCT04445935 . Registered on 24 June 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 2). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"As a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F) ratio.
","['critically ill patients on mechanical ventilation suffering from COVID-19 disease', 'All patients admitted to the Hamad Medical Corporation -ICU in Qatar for COVID-19 associated respiratory distress and in need of mechanical ventilation are screened for eligibility', 'patients suffering from COVID-19 disease', '100 patients (50 in each group', 'all adult patients admitted to the ICU who test positive for COVID-19 by PCR-test and in need for mechanical ventilation are eligible for inclusion', 'patients with COVID-19 and respiratory failure using invasive mechanical ventilation']","['anticoagulant bivalirudin', 'bivalirudin', 'heparin']",[],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]",[],100.0,0.197695,"As a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F) ratio.
","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Kharma', 'Affiliation': 'Department of Medical Intensive Care, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roehrig', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ahmed Atef', 'Initials': 'AA', 'LastName': 'Shible', 'Affiliation': 'Department of Pharmacy, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Moustafa Sayed', 'Initials': 'MS', 'LastName': 'Elshafei', 'Affiliation': 'Department of Medical Intensive Care, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Dema', 'Initials': 'D', 'LastName': 'Osman', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ingi Mohamed', 'Initials': 'IM', 'LastName': 'Elsaid', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Salma Faisal', 'Initials': 'SF', 'LastName': 'Mustafa', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Asjad', 'Initials': 'A', 'LastName': 'Aldabi', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Osamah A M', 'Initials': 'OAM', 'LastName': 'Smain', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Lance', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar. Mlance@hamad.qa.'}]",Trials,['10.1186/s13063-020-04689-1']
2400,32895067,"Improving the communication of hand hygiene procedures: Controlled observation, redesign, and randomized group comparisons.","OBJECTIVE


To assess the clarity and efficacy of the World Health Organization (WHO) hand-rub diagram, develop a modified version, and compare the 2 diagrams.
DESIGN


Randomized group design preceded by controlled observation and iterative product redesigns.
SETTING


The Cognitive Ergonomics Lab in the School of Psychology at the Georgia Institute of Technology.
PARTICIPANTS


We included participants who were unfamiliar with the WHO hand-rub diagram (convenience sampling) to ensure that performance was based on the diagram and not, for example, on prior experience.
METHODS


We iterated through the steps of a human factors design procedure: (1) Participants simulated hand hygiene using ultraviolet (UV) absorbent lotion and a hand-rub technique diagram (ie, WHO or a redesign). (2) Coverage, confusion judgments, and behavioral videos informed potentially improved diagrams. And (3) the redesigned diagrams were compared with the WHO version in a randomized group design. Coverage was assessed across 72 hand areas from multiple UV photographs.
RESULTS


The WHO diagram led to multiple omissions in hand-surface coverage, including inadequate coverage by up to 75% of participants for the ulnar edge. The redesigns improved coverage significantly overall and often substantially.
CONCLUSIONS


Human factors modification to the WHO diagram reduced inadequate coverage for naïve users. Implementation of an improved diagram should help in the prevention of healthcare-associated infections.",2020,"The redesigns improved coverage significantly overall and often substantially.
","['We included participants who were unfamiliar with the WHO hand-rub diagram (convenience sampling) to ensure that performance was based on the diagram and not, for example, on prior experience']","['human factors design procedure: (1) Participants simulated hand hygiene using ultraviolet (UV) absorbent lotion and a hand-rub technique diagram (ie, WHO or a redesign']","['2) Coverage, confusion judgments, and behavioral videos informed potentially improved diagrams']","[{'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C3873692', 'cui_str': 'Absorbent'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",1.0,0.0462943,"The redesigns improved coverage significantly overall and often substantially.
","[{'ForeName': 'Francis T', 'Initials': 'FT', 'LastName': 'Durso', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Sweta', 'Initials': 'S', 'LastName': 'Parmar', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Heidish', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Skyler', 'Initials': 'S', 'LastName': 'Tordoya Henckell', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Omer S', 'Initials': 'OS', 'LastName': 'Oncul', 'Affiliation': 'School of Psychology, Georgia Institute of Technology, Atlanta, Georgia.'}, {'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Jacob', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University, Atlanta, Georgia.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.407']
2401,32895163,[Dexmedetomidine combined with protective lung ventilation strategy provides lung protection in patients undergoing radical resection of esophageal cancer with one-lung ventilation].,"OBJECTIVE


To investigate the effect of dexmedetomidine combined with pulmonary protective ventilation against lung injury in patients undergoing surgeries for esophageal cancer with one-lung ventilation (OLV).
METHODS


Forty patients with undergoing surgery for esophageal cancer with OLV were randomly divided into pulmonary protective ventilation strategy group (F group) and dexmedetomidine combined with protective ventilation strategy group (DF group;  n =20). In F group, lung protective ventilation strategy during anesthesia was adopte, and in DF group, the patients received intravenous infusion of dexmedetomidine hydrochloride (0.3 μg · kg -1  ·h -1 ) during the surgery starting at 10 min before anesthesia induction in addition to protective ventilation strategy. Brachial artery blood was sampled before ventilation (T 0 ), at 30 and 90 min after the start of OLV (T 1  and T 2 , respectively) and at the end of the surgery (T 3 ) for analysis of superoxide dismutase (SOD), malondialdehyde (MDA), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), arterial oxygenation pressure (PaO 2 ), oxygenation index (OI) and lung compliance (CL).
RESULTS


At the time points of T 1 , T 2  and T 3 , SOD level was significantly higher and IL-6 level was significantly lower in the DF group than in F group ( P  &lt; 0.05). The patients in DF group showed significantly higher PaO 2 , OI and CL index than those in F group at all the 3 time points.
CONCLUSIONS


Dexmedetomidine combined with pulmonary protective ventilation strategy can reduce perioperative lung injury in patients undergoing surgery for esophageal cancer with OLV by suppressing inflammation and oxidative stress to improve lung function and reduce adverse effects of the surgery.",2020,"At the time points of T 1 , T 2  and T 3 , SOD level was significantly higher and IL-6 level was significantly lower in the DF group than in F group ( P  &lt; 0.05).","['patients undergoing radical resection of esophageal cancer with one-lung ventilation', 'patients undergoing surgery for esophageal cancer with OLV', 'Forty patients with undergoing surgery for esophageal cancer with OLV', 'patients undergoing surgeries for esophageal cancer with one-lung ventilation (OLV']","['Dexmedetomidine combined with protective lung ventilation strategy', 'dexmedetomidine combined with pulmonary protective ventilation', 'dexmedetomidine hydrochloride', 'Dexmedetomidine combined with pulmonary protective ventilation strategy', 'pulmonary protective ventilation strategy group (F group) and dexmedetomidine combined with protective ventilation strategy']","['lung protective ventilation strategy', 'PaO 2 , OI and CL index', 'superoxide dismutase (SOD), malondialdehyde (MDA), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), arterial oxygenation pressure (PaO 2 ), oxygenation index (OI) and lung compliance (CL', 'SOD level', 'IL-6 level', 'Brachial artery blood']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0752310', 'cui_str': 'Dexmedetomidine hydrochloride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441840', 'cui_str': 'Group F'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0024112', 'cui_str': 'Lung compliance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",40.0,0.0490837,"At the time points of T 1 , T 2  and T 3 , SOD level was significantly higher and IL-6 level was significantly lower in the DF group than in F group ( P  &lt; 0.05).","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Nanning 530021, China.'}, {'ForeName': 'Xiaomao', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': ""Department Cardiothoracic Surgery, People's Hospital of Guangxi Autonomous Region, Nanning 530021, China.""}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Department of Anesthesiology, Nanning 530021, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, Nanning 530021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Nanning 530021, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Nanning 530021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""People's Hospital of Guangxi Autonomous Region, Nanning 530021, China.""}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.07.15']
2402,32895196,[Leukotriene D4 bronchial provocation test for detection of airway hyper-responsiveness in children].,"OBJECTIVE


To explore the value of leukotriene D4 (LTD4) bronchial provocation test (BPT) in detection of airway hyper-responsiveness (AHR) in children.
METHODS


A total of 151 children aged 6 to 14 years, including 86 in remission of asthma and 65 with acute bronchitis, who were followed up in our respiratory clinic between November, 2017 and August, 2018. The children were randomly divided into LTD4 group (78 cases) and methacholine (MCH) group (73 cases). In LTD4 group, the 78 children underwent LTD4-BPT, including 46 with asthma and 32 children having re-examination for previous episodes of acute bronchitis; in MCH group, the 73 children underwent MCH-BPT, including 40 with asthma and 33 with acute bronchitis. MCH-BPT was also performed in the asthmatic children in the LTD4 group who had negative responses to LTD4 after an elution period. The major adverse reactions of the children to the two BPT were recorded. The diagnostic values of the two BPT were evaluated using receiver-operating characteristic (ROC) curve.
RESULTS


There was no significant difference in the results of basic lung function tests between LTD4 group and MCH group ( P &gt;0.05). The positive rate of BPT in asthmatic children in the LTD4 group was significantly lower than that in the MCH group (26.1%  vs  72.5%;  P  &lt; 0.05). The positive rate of BPT in children with previous acute bronchitis in the LTD4 group was lower than that in the MCH group (3.1%  vs  15.2%). The positive rate of MCH-BPT in asthmatic children had negative BPT results in LTD4 group was 58.8%, and their asthma was mostly mild. The sensitivity was lower in LTD4 group than in MCH group (0.2609  vs  0.725), but the specificity was slightly higher in LTD4 group (0.9688 vs 0.8485).The area under ROC curvein LTD4 group was lower than that in MCH group (0.635  vs  0.787). In children with asthma in the LTD4 group, the main adverse reactions in BPT included cough (34.8%), shortness of breath (19.6%), chest tightness (15.2%), and wheezing (10.9%). The incidence of these adverse reactions was significantly lower in LTD4 group than in MCH group ( P  &lt; 0.05). Serious adverse reactions occurred in neither of the two groups.
CONCLUSIONS


LTD4-BPT had high safety in clinical application of children and was similar to the specificity of MCH-BPT. However, it had low sensitivity, low diagnostic value, and limited application value in children's AHR detection.",2020,"The sensitivity was lower in LTD4 group than in MCH group (0.2609  vs  0.725), but the specificity was slightly higher in LTD4 group (0.9688 vs 0.8485).The area under ROC curvein LTD4 group was lower than that in MCH group (0.635  vs  0.787).","['children', '78 children underwent', '40 with asthma and 33 with acute bronchitis', '151 children aged 6 to 14 years, including 86 in remission of asthma and 65 with acute bronchitis, who were followed up in our respiratory clinic between November, 2017 and August, 2018']","['MCH', 'Leukotriene D4 bronchial provocation test', 'leukotriene D4 (LTD4) bronchial provocation test (BPT', 'LTD4', 'LTD4-BPT', 'methacholine (MCH', 'MCH-BPT']","['positive rate of MCH-BPT', 'basic lung function tests', 'sensitivity', 'shortness of breath', 'incidence of these adverse reactions', 'chest tightness', 'specificity', 'acute bronchitis', 'Serious adverse reactions', 'positive rate of BPT', 'MCH-BPT', 'wheezing']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0149514', 'cui_str': 'Acute bronchitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0023544', 'cui_str': 'LTD4'}, {'cui': 'C0006265', 'cui_str': 'Bronchial provocation test'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0006265', 'cui_str': 'Bronchial provocation test'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0232292', 'cui_str': 'Tight chest'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0149514', 'cui_str': 'Acute bronchitis'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}]",151.0,0.0229577,"The sensitivity was lower in LTD4 group than in MCH group (0.2609  vs  0.725), but the specificity was slightly higher in LTD4 group (0.9688 vs 0.8485).The area under ROC curvein LTD4 group was lower than that in MCH group (0.635  vs  0.787).","[{'ForeName': 'Fangjun', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Pulmonary Function Test Room, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.""}, {'ForeName': 'Caihui', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ""Pulmonary Function Test Room, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.""}, {'ForeName': 'Jiangjiao', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': ""Pulmonary Function Test Room, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': ""Pulmonary Function Test Room, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.""}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Pulmonary Function Test Room, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, National Clinical Research Center for Child Health and Disorders, Chongqing Key Laboratory of Pediatrics, Chongqing 400014, China.""}]",Nan fang yi ke da xue xue bao = Journal of Southern Medical University,['10.12122/j.issn.1673-4254.2020.06.04']
2403,32895226,Comparison of two techniques (intermittent intravenous bolus morphine vs. morphine infusion) for analgesic titration in patients who had advanced cancer with severe pain: a prospective randomised study.,"OBJECTIVE


To compare the analgesic efficacy of two techniques of morphine titration (intermittent intravenous bolus vs infusion) by calculating rescue dosage in a day at 1 week after analgesic titration.
METHODS


One hundred and forty cancer patients were randomised into two groups. In group 1, intravenous morphine 1.5 mg bolus given every 10 min until Numerical Rating Scale (NRS) pain score <4 is achieved. Total intravenous dose converted to oral dose (1:1) and administered every 4 hours. In group 2, intravenous bolus morphine 0.05 mg/kg body weight administered followed by 0.025 mg/kg/hour intravenous infusion. The NRS pain score was recorded every 10 min but infusion rate was titrated every 30 min if required. The infusion rate of morphine was doubled if the pain score was unchanged and increased to 50% when NRS was between 4 and baseline. If NRS<4, then infusion at same rate was continued. Once the NRS<4 for two consecutive hours, total intravenous dose for 24 hours was calculated and converted to oral morphine in a ratio of 1:3 and divided into six doses given over 24 hours. For rescue (pain score ≥4) analgesia, one-sixth of the total daily oral dose was prescribed. The primary outcome of this study was to note the number of rescue doses of oral morphine in a day at 1 week.
RESULTS


The rescue dosage in a day at 1-week post discharge from the palliative care unit was significantly higher in group 1 as compared with group 2.
CONCLUSION


Intravenous infusion morphine may be a better analgesic titration technique for analgesia in patients with advanced cancer.
TRIAL REGISTRATION NUMBER


CTRI/2018/04/013369.",2020,"The rescue dosage in a day at 1-week post discharge from the palliative care unit was significantly higher in group 1 as compared with group 2.
","['patients who had advanced cancer with severe pain', 'One hundred and forty cancer patients', 'patients with advanced cancer']","['intravenous bolus morphine', 'morphine titration', 'morphine vs. morphine infusion', 'morphine']","['NRS pain score', 'Numerical Rating Scale (NRS) pain score', 'infusion rate of morphine', 'pain score', 'number of rescue doses of oral morphine', 'analgesic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",140.0,0.129529,"The rescue dosage in a day at 1-week post discharge from the palliative care unit was significantly higher in group 1 as compared with group 2.
","[{'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India vkchanpadia@gmail.com.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Sirohiya', 'Affiliation': 'Anaesthesia, Dr Ram Manohar Lohia Hospital and Post Graduate Institute of Medical Education and Research, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Garg', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Nishkarsh', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sachidanand Jee', 'Initials': 'SJ', 'LastName': 'Bharti', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Thirumurthy', 'Initials': 'T', 'LastName': 'Velpandian', 'Affiliation': 'Department of Ocular Pharmacology, Dr Rajendra Prasad Centre for Opthalmic Sciences, All India Institute of Medical Sciences, New Delhi, Delhi, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': 'Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences, New Delhi, India.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002397']
2404,32895332,Equivalent performance of single-use and reusable duodenoscopes in a randomised trial.,"OBJECTIVE


Single-use duodenoscopes have been recently developed to eliminate risk of infection transmission from contaminated reusable duodenoscopes. We compared performances of single-use and reusable duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
DESIGN


Patients with native papilla requiring ERCP were randomised to single-use or reusable duodenoscope. Primary outcome was comparing number of attempts to achieve successful cannulation of desired duct. Secondary outcomes were technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events.
RESULTS


98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures. While median number of attempts to achieve successful cannulation was significantly lower for single-use cohort (2 vs 5, p=0.013), ease of passage into stomach (p=0.047), image quality (p<0.001), image stability (p<0.001) and air-water button functionality (p<0.001) were significantly worse. There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts. On multivariate logistic regression analysis, only duodenoscope type (single-use) was associated with less than six attempts to achieve selective cannulation (p=0.012), when adjusted for patient demographics, procedural complexity and type of intervention.
CONCLUSION


Given the overall safety profile and similar technical performance, single-use duodenoscopes represent an alternative to reusable duodenoscopes for performing low-complexity ERCP procedures in experienced hands.
TRIAL REGISTRATION NUMBER


Clinicaltrials.gov number: NCT04143698.",2020,"There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts.","['98 patients were treated using single-use (n=48) or reusable (n=50) duodenoscopes with >80% graded as low-complexity procedures', 'Patients with native papilla requiring ERCP', 'patients undergoing endoscopic retrograde cholangiopancreatography (ERCP']","['single-use or reusable duodenoscope', 'single-use and reusable duodenoscopes']","['median number of attempts to achieve successful cannulation', 'rate of cannulation, adverse events including mortality', 'overall safety profile and similar technical performance', 'technical performance that measured duodenoscope manoeuvrability, mechanical-imaging characteristics and ability to perform therapeutic interventions, need for advanced cannulation techniques or cross-over to alternate duodenoscope group to achieve ductal access and adverse events', 'image quality (p<0.001), image stability (p<0.001) and air-water button functionality', 'ease of passage into stomach', 'number of attempts to achieve successful cannulation of desired duct']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0180565', 'cui_str': 'Duodenoscope'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0180565', 'cui_str': 'Duodenoscope'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0180565', 'cui_str': 'Duodenoscope'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}]",98.0,0.131927,"There was no significant difference in rate of cannulation, adverse events including mortality (one patient in each group), need to cross-over or need for advanced cannulation techniques to achieve ductal access, between cohorts.","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawes', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, USA svaradarajulu@yahoo.com.'}]",Gut,['10.1136/gutjnl-2020-321836']
2405,32895334,WASh multicentre randomised controlled trial: water-assisted sigmoidoscopy in English NHS bowel scope screening.,"OBJECTIVES


The English Bowel Cancer Screening Programme invites 55 year olds for a sigmoidoscopy (Bowel Scope Screening (BSS)), aiming to resect premalignant polyps, thus reducing cancer incidence. A national patient survey indicated higher procedural pain than anticipated, potentially impacting on screening compliance and effectiveness. We aimed to assess whether water-assisted sigmoidoscopy (WAS), as opposed to standard CO 2  technique, improved procedural pain and detection of adenomatous polyps.
DESIGN


The WASh (Water-Assisted Sigmoidoscopy) trial was a multicentre, single-blind, randomised control trial for people undergoing BSS. Participants were randomised to either receive WAS or CO 2  from five sites across England. The primary outcome measure was patient-reported moderate/severe pain, as assessed by patients on a standard Likert scale post procedure prior to discharge. The key secondary outcome was adenoma detection rate (ADR). The costs of each technique were also measured.
RESULTS


1123 participants (50% women, mean age 55) were randomised (561 WAS, 562 CO 2 ). We found no difference in patient-reported moderate/severe pain between WAS and CO 2  (14% in WAS, 15% in CO2; p=0.47). ADR was 15% in the CO 2  arm and 11% in the WAS arm (p=0.03); however, it remained above the minimum national performance standard in both arms. There was no statistical difference in mean number of adenomas nor overall polyp detection rate. There was negligible cost difference between the two techniques.
CONCLUSION


In the context of enema-prepared unsedated screening sigmoidoscopies performed by screening-accredited endoscopists, no difference in patient-reported pain was seen when using either a CO 2  or WAS intubation technique.
TRIAL REGISTRATION NUMBER


ISRCTN81466870.",2020,"ADR was 15% in the CO 2  arm and 11% in the WAS arm (p=0.03); however, it remained above the minimum national performance standard in both arms.","['people undergoing BSS', '1123 participants (50% women, mean age 55']","['water-assisted sigmoidoscopy', 'water-assisted sigmoidoscopy (WAS', 'sigmoidoscopy (Bowel Scope Screening (BSS']","['moderate/severe pain', 'patient-reported moderate/severe pain', 'procedural pain', 'mean number of adenomas nor overall polyp detection rate', 'adenoma detection rate (ADR', 'procedural pain and detection of adenomatous polyps', 'standard Likert scale post procedure prior to discharge', 'ADR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005129', 'cui_str': 'Bernard Soulier syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0037075', 'cui_str': 'Sigmoidoscopy'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005129', 'cui_str': 'Bernard Soulier syndrome'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0206677', 'cui_str': 'Adenomatous polyp'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",1123.0,0.337151,"ADR was 15% in the CO 2  arm and 11% in the WAS arm (p=0.03); however, it remained above the minimum national performance standard in both arms.","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Rutter', 'Affiliation': 'Gastroenterology, University Hospital of North Tees, Stockton-on-Tees, UK matt.rutter@nhs.net.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Von Wagner', 'Affiliation': 'Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Deane', 'Affiliation': 'Gastroenterology, University Hospital of North Tees, Stockton-on-Tees, UK.'}, {'ForeName': 'Shiran', 'Initials': 'S', 'LastName': 'Esmaily', 'Affiliation': 'Gastroenterology, University Hospital of North Tees, Stockton-on-Tees, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Larkin', 'Affiliation': 'Hartlepool, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Seow Tien', 'Initials': 'ST', 'LastName': 'Yeo', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Llinos Haf', 'Initials': 'LH', 'LastName': 'Spencer', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': 'Centre for Health Economics & Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Saunders', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital, London, UK.""}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Rees', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Zacharias P', 'Initials': 'ZP', 'LastName': 'Tsiamoulos', 'Affiliation': ""Wolfson Unit for Endoscopy, St Mark's Hospital, London, UK.""}, {'ForeName': 'Iosif', 'Initials': 'I', 'LastName': 'Beintaris', 'Affiliation': 'Gastroenterology, University Hospital of North Tees, Stockton-on-Tees, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2020-321918']
2406,32895339,Effectiveness of Multi Interventional Package on Selected Parameters of Metabolic Syndrome among Women: A Pilot Study.,"PURPOSE


The purpose of the study was to compare the effectiveness of multi interventional package (MIP) and lifestyle interventions (LI) on physiological parameters of women with metabolic syndrome, to compare the effectiveness of MIP and LI on biochemical parameters of women with metabolic syndrome and to compare the effectiveness of MIP and LI on socio-psychological parameters of women with metabolic syndrome.
METHODS


A quasi experimental nonequivalent control group design with two experimental groups and one control group was used to collect data from 60 self-help group women. Samples were selected by multistage sampling. Reflexology foot massage, dietary modification, moderate intensity exercise and structured education were given to MIP group and dietary modification, moderate intensity exercise and structured education were given to LI group for 12 weeks. Control group received routine care. Demographic and clinical data sheets were used to collect basic information. Knowledge was assessed by a knowledge questionnaire. Physiological (weight, body mass index, waist circumference and blood pressure) and biochemical parameters (HDL, triglycerides and FBS) were assessed before and after the intervention.
RESULTS


The study found significant change in the physiological and biochemical parameters of metabolic syndrome as well as knowledge among the MIP group and LI group compared to the control group ( p  < .001).
CONCLUSION


MIP and LI are effective in controlling the parameters of metabolic syndrome. Hence the guidance may be provided to women with metabolic syndrome for adopting necessary lifestyle changes as well as reflexology foot massage to control the physiological and biochemical parameters of metabolic syndrome.",2020,"The study found significant change in the physiological and biochemical parameters of metabolic syndrome as well as knowledge among the MIP group and LI group compared to the control group ( p  < .001).
","['women with metabolic syndrome', 'Metabolic Syndrome among Women']","['Multi Interventional Package', 'MIP and LI', 'multi interventional package (MIP) and lifestyle interventions (LI', 'Reflexology foot massage, dietary modification, moderate intensity exercise and structured education were given to MIP group and dietary modification, moderate intensity exercise and structured education', 'routine care']","['Physiological (weight, body mass index, waist circumference and blood pressure) and biochemical parameters (HDL, triglycerides and FBS', 'physiological and biochemical parameters of metabolic syndrome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]",,0.0259815,"The study found significant change in the physiological and biochemical parameters of metabolic syndrome as well as knowledge among the MIP group and LI group compared to the control group ( p  < .001).
","[{'ForeName': 'Attonassary Jose', 'Initials': 'AJ', 'LastName': 'Elizabeth', 'Affiliation': 'Department of Research, Saveetha University, Chennai, India. elizabethbiju1979@gmail.com.'}, {'ForeName': 'Swaminathan', 'Initials': 'S', 'LastName': 'Aruna', 'Affiliation': 'Medical Surgical Nursing, Saveetha College of Nursing, SIMATS, Chennai, India.'}, {'ForeName': 'Parayidathil Joseph', 'Initials': 'PJ', 'LastName': 'Mercy', 'Affiliation': 'Center for Medical Simulation, Kerala University of Health Sciences, Thrissur, India.'}]",Journal of Korean Academy of Nursing,['10.4040/jkan.20012']
2407,32895343,"[Effects of BeHaS Program on Health Behavior, Physiologic Index and Self-Esteem of the Elderly Living Alone with Metabolic Syndrome Based on Community Based Participatory Research].","PURPOSE


This study aimed to determine the effects of a 12-week metabolic syndrome BeHaS (Be Happy and Strong) program in elderly people with metabolic syndrome living alone, based on a community-based participatory research (CBPR).
METHODS


A nonequivalent control group pre-posttest design was used, and the participants were 43 elderly people living alone (experimental group 24, control group 19). The experimental group received a one-hour program per week and two individual health consultations during 12 weeks. The control group received two sessions about the metabolic syndrome and two individual health consultations. The effects of health behavior, blood pressure, blood sugar levels, abdominal circumference, triglycerides, and self-esteem were evaluated. The data were analyzed using the independent t-test and Mann-Whitney U test.
RESULTS


The health behavior with respect to the metabolic syndrome in the experimental group increased significantly (t = - 3.19,  p  = .002). Both diastolic blood pressure and abdominal circumference decreased in the experimental group (t = 2.00,  p  = .028 and t = 3.91,  p  < .001). No significant differences were observed between the groups in systolic blood pressure, fasting blood sugar levels, triglycerides, and self-esteem.
CONCLUSION


The 12-week metabolic syndrome BeHaS program using community resources improves the health of elderly people with metabolic syndrome living alone. Based on these findings, further studies on the effectiveness of the metabolic syndrome BeHaS program and the experiences of those who participated in the CBPR are warranted.",2020,"Both diastolic blood pressure and abdominal circumference decreased in the experimental group (t = 2.00,  p  = .028 and t = 3.91,  p  < .001).","['elderly people with metabolic syndrome living alone, based on a community-based participatory research (CBPR', '43 elderly people living alone (experimental group 24, control group 19', 'elderly people with metabolic syndrome living alone']","['metabolic syndrome BeHaS', 'BeHaS Program']","['health behavior', 'diastolic blood pressure and abdominal circumference', 'Health Behavior, Physiologic Index and Self-Esteem', 'health behavior, blood pressure, blood sugar levels, abdominal circumference, triglycerides, and self-esteem', 'metabolic syndrome', 'systolic blood pressure, fasting blood sugar levels, triglycerides, and self-esteem']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439044', 'cui_str': 'Lives alone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",43.0,0.0124031,"Both diastolic blood pressure and abdominal circumference decreased in the experimental group (t = 2.00,  p  = .028 and t = 3.91,  p  < .001).","[{'ForeName': 'Jong Im', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Korea.'}, {'ForeName': 'Sun Ae', 'Initials': 'SA', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Korea National University of Transportation, Jeungpyeong, Korea. sakim@ut.ac.kr.'}, {'ForeName': 'Keumok', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, The College of Health and Welfare Woosong University, Daejeon, Korea.'}, {'ForeName': 'Jiyoung', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Korea.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Korea.'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungnam, Korea.National University, Daejeon, Korea.'}, {'ForeName': 'Bon Jeong', 'Initials': 'BJ', 'LastName': 'Ku', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungnam, Korea.National University, Daejeon, Korea.'}]",Journal of Korean Academy of Nursing,['10.4040/jkan.19261']
2408,32914276,Comparison of reading performance with low add bifocal and extended depth of focus intraocular lenses implanted with mini-monovision.,"PURPOSE


To evaluate reading performance, preferred reading distance, and spectacle independence in patients implanted with a low add multifocal or an extended depth of focus (EDOF) intraocular lens (IOL) after phacoemulsification.
METHODS


In this prospective study, patients were randomized into two groups: the diffractive multifocal Tecnis + 2.75 D (ZKB00) IOL (Tecnis + 2.75 group; 15 patients) or the EDOF Tecnis Symfony (ZXR00) IOL (Symfony group; 14 patients) for bilateral implantation with mini-monovision. Reading performance parameters (reading acuity [RA], critical print size [CPS], and maximum reading speed [MRS]) were evaluated with MNREAD acuity charts at 40 cm, and preferred reading distances and spectacle independence for near activities were assessed preoperatively and at the postoperative 1st, 3rd, and 6th months.
RESULTS


At the postoperative 6th month, binocular logMAR UNVA and DCNVA were significantly better in the Symfony group than in the Tecnis + 2.75 group (UNVA: 0.15 ± 0.07 vs. 0.22 ± 0.08, p = 0.046; DCNVA: 0.21 ± 0.05 vs. 0.28 ± 0.07, p = 0.043; respectively). There was no significant difference in reading performance parameters between the groups; however, the Symfony group preferred significantly closer reading distance than the Tecnis + 2.75 group (42.00 ± 4.67 cm; 45.87 ± 5.32 cm, respectively, p = 0.030). At the postoperative 6th month, 14.3% and 26.7% of patients reported that they needed spectacles, rarely or occasionally, for near activities in the Symfony and Tecnis + 2.75 groups, respectively (p > 0.05).
CONCLUSIONS


When implanted with mini-monovision, although functional near visual acuity and a high degree of spectacle independence at near distances were achieved with both IOLs, patients implanted with the EDOF IOL preferred closer reading distance than those implanted with the low add diffractive multifocal IOL.",2020,"There was no significant difference in reading performance parameters between the groups; however, the Symfony group preferred significantly closer reading distance than the Tecnis + 2.75 group (42.00 ± 4.67 cm; 45.87 ± 5.32 cm, respectively, p = 0.030).",['patients implanted with a low add multifocal or an extended depth of focus (EDOF) intraocular lens (IOL) after phacoemulsification'],"['diffractive multifocal Tecnis\u2009+\u20092.75\xa0D (ZKB00) IOL (Tecnis\u2009+\u20092.75 group; 15 patients) or the EDOF Tecnis Symfony (ZXR00) IOL (Symfony group; 14 patients) for bilateral implantation with mini-monovision', 'reading performance with low add bifocal and extended depth of focus intraocular lenses implanted with mini-monovision']","['binocular logMAR UNVA and DCNVA', 'reading performance parameters', 'reading distance', 'Reading performance parameters (reading acuity [RA], critical print size [CPS], and maximum reading speed [MRS', 'reading distances and spectacle independence for near activities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0042797', 'cui_str': 'Monocular vision'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429592', 'cui_str': 'Reading distance'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0229507,"There was no significant difference in reading performance parameters between the groups; however, the Symfony group preferred significantly closer reading distance than the Tecnis + 2.75 group (42.00 ± 4.67 cm; 45.87 ± 5.32 cm, respectively, p = 0.030).","[{'ForeName': 'Semra Akkaya', 'Initials': 'SA', 'LastName': 'Turhan', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Marmara, Cami mah. Ulubay sok. No: 17/6 Tuzla, Istanbul, Turkey. semraakkaya85@hotmail.com.'}, {'ForeName': 'Mehmet Orkun', 'Initials': 'MO', 'LastName': 'Sevik', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Marmara, Cami mah. Ulubay sok. No: 17/6 Tuzla, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Toker', 'Affiliation': 'Department of Ophthalmology, School of Medicine, University of Marmara, Cami mah. Ulubay sok. No: 17/6 Tuzla, Istanbul, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01584-1']
2409,32914421,Evaluation of a dynamic navigation system for training students in dental implant placement.,"OBJECTIVE


Computer-guided simulation systems may offer a novel training approach in many surgical fields. This study aimed to compare dental students' learning progress in dental implants placement between a dynamic navigation system and a traditional training method using a simulation model.
METHODS


Senior dental students with no implant placement experience were randomly assigned to implant placement training using a dynamic navigation system or a traditional freehand protocol. After training, 3-dimensional (3D) deviation at implant platform, 3D deviation at implant apex, and deviation of implant axis between the planned and placed implant positions were measured using superimposed cone beam computed tomography scans.
RESULTS


Six students were trained in this study. Students showed significantly greater improvement in implant placement after training using the dynamic navigation system than after using the traditional freehand protocol. Overall deviation of implant axis (P < 0.001) and 3D apex deviation (P = 0.014) improved with training using the dynamic navigation system, but differences in 3D platform deviation (P = 0.513) were not statistically significant.
CONCLUSIONS


A dynamic navigation system may be a useful teaching tool in the early development of clinical skills in implant placement for the novice practitioners. Novice practitioners exhibited significant improvement in angulation deviation across implant placement attempts with dynamic navigation system training.",2020,A dynamic navigation system may be a useful teaching tool in the early development of clinical skills in implant placement for the novice practitioners.,"['Senior dental students with no implant placement experience', 'training students in dental implant placement', 'Six students']","['implant placement training using a dynamic navigation system or a traditional freehand protocol', 'dynamic navigation system training', 'dynamic navigation system']","['Overall deviation of implant axis', '3D apex deviation', '3D platform deviation', 'implant placement', 'angulation deviation']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}]",6.0,0.0360469,A dynamic navigation system may be a useful teaching tool in the early development of clinical skills in implant placement for the novice practitioners.,"[{'ForeName': 'Yalin', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Miaozhen', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Xiaorui', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'First Clinical Division, Peking University School and Hospital of Stomatology, Beijing, China.'}]",Journal of dental education,['10.1002/jdd.12399']
2410,32914483,"The effect of black barberry hydroalcoholic extract on immune mediators in patients with active rheumatoid arthritis: A randomized, double-blind, controlled clinical trial.","Rheumatoid arthritis (RA) is an autoimmune disease associated with inflammation. In this trial, we aimed to investigate the Immunomodulatory effect of hydroalcoholic extract of black barberry on immune mediators in patients with active rheumatoid arthritis. In this randomized, double-blind, placebo-controlled clinical trial, 80 women with active RA were randomly assigned into two groups of two capsules, each containing 1,000 mg black barberry extract (n = 40) or maltodextrin placebo (n = 40) daily for 12 weeks. Demographic indices, physical activity, dietary intake, and disease activity were investigated using suitable questionnaires. Concentration of cytokines IL-2, IL-4, IL-10, and IL-17 in blood sample were measured using PBMC method. Statistical analysis was performed using SPSS (version 22). At baseline, there were no differences between the two groups in terms of demographic indices, physical activity, and dietary intake (p > .05). Black barberry supplementation reduced the severity of RA. It showed no significant effect on IL-2 and IL-4 cytokines (p > .05). IL-17 levels decreased significantly after the intervention within the black barberry group, while IL-10 had a significant increase in this group (p < .05). Barberry extract may reduce inflammatory and increase anti-inflammatory cytokines in RA, and stimulates the immune response by increasing Th2 production.",2020,"At baseline, there were no differences between the two groups in terms of demographic indices, physical activity, and dietary intake (p > .05).","['patients with active rheumatoid arthritis', '80 women with active RA']","['hydroalcoholic extract of black barberry', 'placebo', 'black barberry hydroalcoholic extract', 'black barberry extract', 'maltodextrin placebo']","['Concentration of cytokines IL-2, IL-4, IL-10, and IL-17 in blood sample', 'severity of RA', 'IL-2 and IL-4 cytokines', 'IL-17 levels', 'Demographic indices, physical activity, dietary intake, and disease activity', 'immune mediators', 'demographic indices, physical activity, and dietary intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0873066', 'cui_str': 'Barberry Extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",80.0,0.595307,"At baseline, there were no differences between the two groups in terms of demographic indices, physical activity, and dietary intake (p > .05).","[{'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Hadidi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Rheumatology Research Center of Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Asgari', 'Affiliation': 'Rheumatology Research Center of Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zohreh Sajadi', 'Initials': 'ZS', 'LastName': 'Hezaveh', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara Khorshidi', 'Initials': 'SK', 'LastName': 'Sadehi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6874']
2411,32914554,Synthetic media for preservation of corneal tissues deemed for endothelial keratoplasty and endothelial cell culture.,"PURPOSE


To compare the difference between various endothelial graft preparation methods and endothelial cell culture from tissues that are preserved in serum-based and synthetic medium.
METHODS


In a randomized masked study, the tissues (n = 64) were preserved in Cornea Max (serum-based) and Cornea Syn (synthetic) series for 36 days at their respective preservation conditions. Following organ culture, corneal tissues (n = 48) were used to prepareDescemet stripping automated endothelial keratoplasty (DSAEK), preloaded ultra-thin (UT) -DSAEK, prestripped Descemet membrane endothelial keratoplasty (DMEK), free-floating DMEK, and preloaded DMEK with endothelium inward and outward grafts. These tissues were preserved for another 4days at room temperature in dextran supplemented media following which they were subjected to trypan blue, alizarin red, live/dead and Zonula Occludens-1 (ZO-1) staining. A separate set of tissues (n = 16) from both the series was used for human corneal endothelial cell (HCEnC) culture. At confluence, the proliferation and cell doubling rate was calculated and the cultured cells were subjected to live/dead, ZO-1, 2A12 and Ki-67 staining. Mann-Whitney test was performed with p < 0.05 deemed statistically significant.
RESULTS


After preparation and preservation of the tissues for endothelial keratoplasty, alizarin red showed standard endothelial morphology from both the groups. Endothelial cell loss, hexagonality and uncovered areas did not show statistically significant differences (p > 0.05) between both groups. For HCEnC, cell doubling rate was 4.7 days (p > 0.05). All the antibodies were expressed in both the groups. Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity were not statistically significant (p > 0.05).
CONCLUSIONS


Complete synthetic organ culture series is safe and advantageous for carrying out advanced endothelial keratoplasty graft preparation procedures and for HCEnC culture as it is free from animal or animal-derived products.",2020,"Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity were not statistically significant (p > 0.05).
",[],"['prepareDescemet stripping automated endothelial keratoplasty (DSAEK), preloaded ultra-thin (UT) -DSAEK']","['Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity', 'proliferation and cell doubling rate', 'Cornea Max (serum-based) and Cornea Syn (synthetic) series', 'Endothelial cell loss, hexagonality']",[],"[{'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}, {'cui': 'C0205168', 'cui_str': 'Thin'}]","[{'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}]",64.0,0.0309539,"Hexagonality, polymorphism, cell area, viable/dead cells and Ki-67 positivity were not statistically significant (p > 0.05).
","[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Parekh', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gallon', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ponzin', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Institute of Ophthalmology, University College London, London, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrari', 'Affiliation': 'International Center for Ocular Physiopathology, Fondazione Banca degli Occhi del Veneto Onlus, Venice, Italy.'}]",Acta ophthalmologica,['10.1111/aos.14583']
2412,32914652,Local Autograft Versus Iliac Crest Bone Graft PSF-Augmented TLIF in Low-Grade Isthmic and Degenerative Lumbar Spondylolisthesis.,"STUDY DESIGN


Prospective randomized controlled cohort study.
OBJECTIVE


To compare the outcome of local autograft versus iliac crest bone graft (ICBG) stand-alone transforaminal lumbar interbody fusion (TLIF) in lumbar spondylolisthesis.
METHODS


One hundred eight patients with low-grade single-level spondylolisthesis underwent operation with pedicular screw fixation (PSF)-augmented stand-alone TLIF. Patients were randomly divided into groups according to bone graft: group I, autograft group; and group II, ICBG group, with 54 patients each. Fifty-nine patients had isthmic spondylolisthesis and 49 had degenerative spondylolisthesis. Clinical outcome parameters included Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and patient's satisfaction, while the radiological parameters included fusion rate, slip reduction, segmental angle, and disc height. The mean follow-up period was 38 ± 19 months, with a minimum 24 of months.
RESULTS


The preoperative VAS of back pain improved from 8 ± 3.1 to 3.4 ± 2.9 and from 8 ± 3.2 to3.6 ± 2.6 in group I and group II, respectively. The preoperative ODI improved from 41.4 ± 8 to 12.3 ± 7 and from 39 ± 9 to 13 ± 8 in group I and group II, respectively. The fusion rate was 93% in group I and 94.5% in group II. The percentage of slip was reduced from 26.7 ± 7.1% to 16.5 ± 6.1% in group I and from 27.4 ± 8.25 to 15.8 ± 5.2% in group II. Intervertebral disc height increased from 25.27 ± 14.62 to 46.38 ± 15.41 in group I and from 22.29 ± 13.72 to 45.15 ± 16.77 in group II. Segmental angle improved from 10.5 ± 8.1° to 16.7 ± 5.4° in group I and from 11.6 ± 5.3° to 15.9 ± 6.2° in group II. There was no significant difference of the above-mentioned parameters between the 2 groups.
CONCLUSION


Patients with single-level low-grade spondylolisthesis can be effectively treated with PSF-augmented stand-alone TLIF using either local autograft or ICBG with no outcome differences between the 2 groups.",2020,Segmental angle improved from 10.5 ± 8.1° to 16.7 ± 5.4° in group I and from 11.6 ± 5.3° to 15.9 ± 6.2° in group II.,"['One hundred eight patients with low-grade single-level spondylolisthesis underwent operation with', 'lumbar spondylolisthesis', 'Fifty-nine patients had isthmic spondylolisthesis and 49 had degenerative spondylolisthesis', 'Low-Grade Isthmic and Degenerative Lumbar Spondylolisthesis']","['Local Autograft Versus Iliac Crest Bone Graft PSF-Augmented TLIF', 'pedicular screw fixation (PSF)-augmented stand-alone TLIF', 'ICBG', 'local autograft versus iliac crest bone graft (ICBG) stand-alone transforaminal lumbar interbody fusion (TLIF']","[""Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and patient's satisfaction, while the radiological parameters included fusion rate, slip reduction, segmental angle, and disc height"", 'preoperative VAS of back pain', 'Intervertebral disc height', 'percentage of slip', 'fusion rate', 'preoperative ODI', 'Segmental angle']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0746025', 'cui_str': 'Lumbar spondylolisthesis'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0410656', 'cui_str': 'Isthmic spondylolisthesis'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021815', 'cui_str': 'Structure of intervertebral disc'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",108.0,0.0209326,Segmental angle improved from 10.5 ± 8.1° to 16.7 ± 5.4° in group I and from 11.6 ± 5.3° to 15.9 ± 6.2° in group II.,"[{'ForeName': 'Ali M', 'Initials': 'AM', 'LastName': 'Abou-Madawi', 'Affiliation': '68831Suez Canal University Hospital, Ismailia, Egypt.'}, {'ForeName': 'Sherif H', 'Initials': 'SH', 'LastName': 'Ali', 'Affiliation': '68831Suez Canal University Hospital, Ismailia, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abdelmonem', 'Affiliation': '68831Suez Canal University Hospital, Ismailia, Egypt.'}]",Global spine journal,['10.1177/2192568220946319']
2413,32914653,Replication of randomized clinical trial results using real-world data: paving the way for effectiveness decisions.,"The FDA is preparing guidance about using real-world evidence (RWE) to support decisions about product effectiveness. Several ongoing efforts aim to replicate randomized clinical trial (RCT) results using RWE with the intent of identifying circumstances and methods that provide valid evidence of drug effects. Lack of agreement may not be due to faulty methods but rather to the challenges with emulating RCTs, differences in healthcare settings and patient populations, differences in effect measures and data analysis, bias, and/or the efficacy-effectiveness gap. In fact, for some decisions, RWE may lead to better understanding of how treatments work in usual care settings than a more constrained view from RCTs. Efforts to reconcile the role and opportunities for generating complementary evidence from RWE and RCTs will advance regulatory science.",2020,"In fact, for some decisions, RWE may lead to better understanding of how treatments work in usual care settings than a more constrained view from RCTs.",[],[],[],[],[],[],,0.148918,"In fact, for some decisions, RWE may lead to better understanding of how treatments work in usual care settings than a more constrained view from RCTs.","[{'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Sheffield', 'Affiliation': 'Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Dreyer', 'Affiliation': 'IQVIA Real-World & Analytic Solutions, Cambridge, MA 02139, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Murray', 'Affiliation': 'Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Faries', 'Affiliation': 'Real World Analytics, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Klopchin', 'Affiliation': 'Global Patient Outcomes & Real World Evidence, Eli Lilly & Company, Indianapolis, IN 46225, USA.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0161']
2414,32914666,Maximal inspiratory pressure is associated with health-related quality of life and is a reliable method for evaluation of patients on hemodialysis.,"OBJECTIVE


To evaluate the association between Maximal Inspiratory Pressure (MIP) and health-related quality of life (HRQoL) and to verify the reliability of the MIP in patients on hemodialysis.
METHODS


In a repeated-measures design, patients on hemodialysis performed MIP and specific HRQoL questionnaire (trial 1). The MIP was repeated after 6 to 8 weeks (trial 2) and reliability was assessed using Intra-class Correlation Coefficient. Standard Error of Measurement and Minimal Detectable Change scores were calculated.
RESULTS


Sixty-one individuals (68.9% men) were evaluated in trial 1. MIP was associated with specific domains ""Symptoms"" (r = 0.45; R 2  adjusted = 0.192) and the kidney disease component summary (r = 0.38; R 2  adjusted = 0.138). Regarding generic domains, the MIP was associated with ""Physical Functioning"" (r = 0.57; R 2  adjusted = 0.375) and Physical component summary (r = 0.47; R 2  adjusted = 0.258). Thirty-three patients were randomly selected to perform a second MIP test (trial 2). The Intra-class Correlation Coefficient was 0.94 (95%CI 0.88-0.97). By Bland-Altman analysis, the bias was 3.2 cmH2O, which represents a difference of 3.7%. The Standard Error of Measurement and Minimal Detectable Change for MIP were 5.9 cmH2O and 13.8 cmH2O, respectively.
CONCLUSION


The MIP is a reliable test, associated with physical domains of HRQoL in patients on hemodialysis. Thus, it is a useful method for respiratory evaluation in this population.",2020,"MIP was associated with specific domains ""Symptoms"" (r = 0.45; R 2  adjusted = 0.192) and the kidney disease component summary (r = 0.38; R 2  adjusted = 0.138).","['Sixty-one individuals (68.9% men', 'patients on hemodialysis', 'Thirty-three patients']",[],"['Physical Functioning', 'Maximal inspiratory pressure', 'Maximal Inspiratory Pressure (MIP) and health-related quality of life (HRQoL', 'kidney disease component summary']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0450358', 'cui_str': '33'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",33.0,0.0449164,"MIP was associated with specific domains ""Symptoms"" (r = 0.45; R 2  adjusted = 0.192) and the kidney disease component summary (r = 0.38; R 2  adjusted = 0.138).","[{'ForeName': 'Carlos Filipe', 'Initials': 'CF', 'LastName': 'Vieira', 'Affiliation': 'Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Diamantina, Brazil.'}, {'ForeName': 'Henrique S', 'Initials': 'HS', 'LastName': 'Costa', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Minas Gerais, Brazil.'}, {'ForeName': 'Márcia M O', 'Initials': 'MMO', 'LastName': 'Lima', 'Affiliation': 'Departamento de Fisioterapia, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Minas Gerais, Brazil.'}, {'ForeName': 'Frederico L', 'Initials': 'FL', 'LastName': 'Alves', 'Affiliation': 'Hemodialysis Unit, Santa Casa de Caridade de Diamantina Hospital , Diamantina, Brazil.'}, {'ForeName': 'Vanessa G B', 'Initials': 'VGB', 'LastName': 'Rodrigues', 'Affiliation': 'Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Diamantina, Brazil.'}, {'ForeName': 'Emílio Henrique B', 'Initials': 'EHB', 'LastName': 'Maciel', 'Affiliation': 'Hemodialysis Unit, Santa Casa de Caridade de Diamantina Hospital , Diamantina, Brazil.'}, {'ForeName': 'Maria Cecília S M', 'Initials': 'MCSM', 'LastName': 'Prates', 'Affiliation': 'Hemodialysis Unit, Santa Casa de Caridade de Diamantina Hospital , Diamantina, Brazil.'}, {'ForeName': 'Vanessa P', 'Initials': 'VP', 'LastName': 'Lima', 'Affiliation': 'Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Diamantina, Brazil.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Mendonça', 'Affiliation': 'Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Diamantina, Brazil.'}, {'ForeName': 'Ana Cristina R', 'Initials': 'ACR', 'LastName': 'Lacerda', 'Affiliation': 'Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Diamantina, Brazil.'}, {'ForeName': 'Pedro Henrique S', 'Initials': 'PHS', 'LastName': 'Figueiredo', 'Affiliation': 'Programa de Pós-Graduação em Reabilitação e Desempenho Funcional, Universidade Federal dos Vales do Jequitinhonha e Mucuri , Diamantina, Brazil.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1818338']
2415,32914838,Evaluation of a Text Messaging-Based Human Papillomavirus Vaccination Intervention for Young Sexual Minority Men: Results from a Pilot Randomized Controlled Trial.,"BACKGROUND


Men who have sex with men (MSM) are at high risk for human papillomavirus (HPV) infection and HPV-related anal cancer. Although a safe and effective vaccine is available to prevent HPV infection, HPV vaccine uptake among young MSM remains low.
PURPOSE


This pilot randomized controlled trial tested the acceptability, feasibility, and preliminary efficacy of a text messaging-based HPV vaccination intervention for young sexual minority men.
METHODS


In 2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect. Participants (N = 150) were randomized to the intervention or control condition. Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination. Participants received daily text messages for the first 3 weeks and monthly text messages for the remaining ~8 months of the trial. Participants completed surveys at baseline and 3 week and 9 month follow-ups.
RESULTS


Participants reported high satisfaction with the intervention. Although trial retention was high (with over 88% completing the 9 month survey), the study fell short of meeting its recruitment goal. HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%), odds ratio = 3.43, 95% confidence interval: 1.17, 10.08.
CONCLUSIONS


Findings suggest that txt2protect is an acceptable and potentially promising intervention for increasing HPV vaccine initiation among young sexual minority men.
CLINICAL TRIAL REGISTRATION


NCT02994108.",2020,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"['young sexual minority men', 'Participants (N = 150', 'Young Sexual Minority Men', '2018, unvaccinated sexual minority men aged 18-25 years were recruited from Chicago to participate in a 9 month sexual health program called txt2protect', 'Men who have sex with men (MSM']","['Intervention condition messages focused primarily on HPV vaccination, with only a brief mention of other sexual health practices (e.g., condom use and HIV testing), while control condition messages focused on a variety of sexual health practices with only a brief mention of HPV vaccination', 'Text Messaging-Based Human Papillomavirus Vaccination Intervention', 'text messaging-based HPV vaccination intervention']",['HPV vaccine series initiation'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C4277573', 'cui_str': 'Lesbigay Persons'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",150.0,0.217267,HPV vaccine series initiation was significantly higher among intervention participants (19.4%) compared to control participants (6.6%),"[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Gerend', 'Affiliation': 'Department of Behavioral Sciences and Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Madkins', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Shariell', 'Initials': 'S', 'LastName': 'Crosby', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Korpak', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Phillips', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bass', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Houlberg', 'Affiliation': 'Howard Brown Health, Chicago, IL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa056']
2416,32914847,The impact of aircraft noise on vascular and cardiac function in relation to noise event number - a randomized trial.,"AIMS


Nighttime aircraft noise exposure has been associated with increased risk of hypertension and myocardial infarction, mechanistically linked to sleep disturbance, stress and endothelial dysfunction. It is unclear, whether the most widely used metric to determine noise exposure, equivalent continuous sound level (Leq), is an adequate indicator of the cardiovascular impact induced by different noise patterns.
METHODS AND RESULTS


In a randomized crossover study, we exposed 70 individuals with established cardiovascular disease or increased cardiovascular risk to two aircraft noise scenarios and one control scenario. Polygraphic recordings, echocardiography and flow-mediated dilation was determined for 3 study nights. The noise patterns consisted of 60 (Noise60) and 120 (Noise120) noise events, respectively, but with comparable Leq, corresponding to a mean value of 45 dB. Mean value of noise during control nights was 37 dB. During the control night, flow-mediated vasodilation (FMD) was 10.02±3.75%, compared to 7.27±3.21% for Noise60 nights and 7.21±3.58% for Noise120 nights (p<0.001). Sleep quality was impaired after noise exposure in both noise scenario nights (p<0.001). Serial echocardiographic assessment demonstrated an increase in the E/E' ratio, a measure of diastolic function, within the three exposure nights, with a ratio of 6.83±2.26 for the control night, 7.21±2.33 for Noise60 and 7.83±3.07 for Noise120 (p=0.043).
CONCLUSIONS


Nighttime exposure to aircraft noise with similar Leq, but different number of noise events, results in a comparable worsening of vascular function. Adverse effects of nighttime aircraft noise exposure on cardiac function (diastolic dysfunction) seemed stronger the higher number of noise events.
TRANSLATIONAL PERSPECTIVE


With the present field study, we tested whether 60 versus 120 simulated aircraft noise events with an equal average sound pressure level (Leq) have comparable adverse effects on endothelial and diastolic function of the heart of subjects with established cardiovascular disease or at increased cardiovascular risk. The results demonstrated that two different nighttime noise patterns with similar Leq, despite different number of noise events, results in a comparable worsening of vascular and cardiac diastolic function. These results may explain at least in part the increased incidence of coronary heart disease and heart failure being observed in response to nighttime aircraft noise.",2020,"Adverse effects of nighttime aircraft noise exposure on cardiac function (diastolic dysfunction) seemed stronger the higher number of noise events.
","['subjects with established cardiovascular disease or at increased cardiovascular risk', '70 individuals with established cardiovascular disease or increased cardiovascular risk to two aircraft noise scenarios and one control scenario']","['aircraft noise', 'nighttime aircraft noise exposure']","['cardiac function (diastolic dysfunction', 'Polygraphic recordings, echocardiography and flow-mediated dilation', ""E/E' ratio, a measure of diastolic function"", 'flow-mediated vasodilation (FMD', 'vascular and cardiac diastolic function', 'Sleep quality', 'coronary heart disease and heart failure']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001881', 'cui_str': 'Aircraft'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001881', 'cui_str': 'Aircraft'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0015331', 'cui_str': 'Exposure to noise'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]",70.0,0.0281964,"Adverse effects of nighttime aircraft noise exposure on cardiac function (diastolic dysfunction) seemed stronger the higher number of noise events.
","[{'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'Schmidt', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Herzog', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schnorbus', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Mir Abolfazl', 'Initials': 'MA', 'LastName': 'Ostad', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Lasetzki', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hahad', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Gianna', 'Initials': 'G', 'LastName': 'Schäfers', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Sørensen', 'Affiliation': 'Diet, Genes and Environment Unit, Danish Cancer Society Research Center, Copenhagen, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Daiber', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Center for Cardiology - Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.'}]",Cardiovascular research,['10.1093/cvr/cvaa204']
2417,32914852,General and Eating Disorder Psychopathology in Relation to Short- and Long-Term Weight Change in Treatment-Seeking Children: A Latent Profile Analysis.,"BACKGROUND


Concurrent general psychopathology (GP) and eating disorder psychopathology (EDP) are commonly reported among youth with overweight/obesity and may impact weight change.
PURPOSE


We identified patterns of GP and EDP in children with overweight/obesity and examined the impact on weight change following family-based behavioral obesity treatment (FBT) and maintenance interventions.
METHODS


Children (N = 172) participated in 4 month FBT and subsequent 8 month weight maintenance interventions. GP and EDP were assessed prior to FBT (baseline). Child percentage overweight was assessed at baseline, post-FBT (4 months), and post-maintenance (12 months). Latent profile analysis identified patterns of baseline GP and EDP. Linear mixed-effects models examined if profiles predicted 4- and 12-month change in percentage overweight and if there were two-way and three-way interactions among these variables, adjusting for relevant covariates.
RESULTS


Results indicated a three-profile structure: lower GP and EDP (LOWER); subclinically elevated GP and EDP without loss of control (LOC; HIGHER); and subclinically elevated GP and EDP with LOC (HIGHER + LOC). Across profiles, children on average achieved clinically meaningful weight loss (i.e., ≥9 unit change in percentage overweight) from baseline to 4 month FBT and sustained these improvements at 12 month maintenance. There was no evidence that latent profiles were related to percentage overweight change from baseline to FBT (p > .05) or baseline to maintenance (p > .05). There was no evidence for two-way or three-way interactions (p > .05).
CONCLUSION


Concurrent GP and EDP do not portend differential short- or long-term weight change following FBT and maintenance. Future research is warranted on the durability of weight change among youth with GP and EDP.
TRIAL REGISTRATION


NCT00759746.",2020,There was no evidence that latent profiles were related to percentage overweight change from baseline to FBT (p > .05) or baseline to maintenance (p > .05).,"['Treatment-Seeking Children', 'youth with GP and EDP', 'children with overweight/obesity and examined the impact on weight change following family-based behavioral obesity treatment (FBT) and maintenance interventions', 'Children (N = 172) participated in 4 month FBT and subsequent 8 month weight maintenance interventions']",['GP and EDP'],"['meaningful weight loss', 'Child percentage overweight', 'GP and EDP (LOWER); subclinically elevated GP and EDP without loss of control (LOC; HIGHER); and subclinically elevated GP and EDP with LOC (HIGHER + LOC', 'GP and EDP']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424666', 'cui_str': 'Percentage overweight'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",172.0,0.0511677,There was no evidence that latent profiles were related to percentage overweight change from baseline to FBT (p > .05) or baseline to maintenance (p > .05).,"[{'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Grammer', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Best', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Balantekin', 'Affiliation': 'Department of Exercise and Nutrition Sciences, School of Public Health and Health Professions, University at Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Rachel P Kolko', 'Initials': 'RPK', 'LastName': 'Conlon', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Saelens', 'Affiliation': ""Department of Pediatrics, University of Washington and Seattle Children's Research Institute, Seattle, WA, USA.""}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa076']
2418,32914866,Pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer without tumor PD-L1 expression: A pooled analysis of 3 randomized controlled trials.,"BACKGROUND


Pembrolizumab plus platinum-based chemotherapy has demonstrated improved clinical outcomes over chemotherapy alone in patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. This study pooled data from 3 randomized controlled trials to evaluate outcomes with pembrolizumab plus chemotherapy versus chemotherapy alone in patients with advanced/metastatic NSCLC negative for PD-L1 (ie, a tumor proportion score < 1%).
METHODS


Individual patient data were pooled from KEYNOTE-021 cohort G (nonsquamous; NCT02039674), KEYNOTE-189 (nonsquamous; NCT02578680 and NCT03950674), and KEYNOTE-407 (squamous; NCT02775435). Treatment comprised pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel for squamous histology) or chemotherapy alone. Responses were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded, independent, central review. No α was assigned to this descriptive, exploratory analysis.
RESULTS


Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n = 155; squamous, n = 94; other, n = 7] and 188 on chemotherapy alone [nonsquamous, n = 83; squamous, n = 99; other, n = 6]). The median time from randomization to the data cutoff was 28.0 months (range, 14.7-55.4 months). Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy. Sixteen patients in the pembrolizumab plus chemotherapy arm completed 2 years of treatment; the objective response rate was 87.5% (95% CI, 61.7%-98.4%), and the 3-year OS rate was 100%. Adverse events (AEs) were experienced by 99.2% of the patients who received pembrolizumab plus chemotherapy and by 98.9% of the patients who received chemotherapy alone, with grade 3 or higher AEs occurring in 71.4% and 72.0%, respectively; immune-mediated AEs and infusion reactions were experienced by 29.0% and 12.4%, respectively.
CONCLUSIONS


Pembrolizumab plus chemotherapy demonstrated response and survival improvements with manageable safety in comparison with chemotherapy alone in PD-L1-negative advanced/metastatic NSCLC, and it is a standard-of-care first-line therapy for patients with advanced NSCLC, regardless of PD-L1 expression.
LAY SUMMARY


Some tumors produce a protein called programmed death ligand 1 (PD-L1), which interacts with the body's immune system and prevents an immune response against cancer. Antibody therapies such as pembrolizumab block interactions between tumor PD-L1 and the immune system and enable an immune response. Used alone, pembrolizumab provides benefit for patients with non-small cell lung cancer (NSCLC) tumors that produce PD-L1. However, when it is combined with chemotherapy, which can stimulate anticancer immune responses, pembrolizumab provides a benefit, regardless of tumor PD-L1 production. This article shows that among patients with NSCLC whose tumors produce no PD-L1, outcomes are better with pembrolizumab plus chemotherapy in comparison with chemotherapy alone.",2020,"Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy.","['patients with advanced non-small cell lung cancer without tumor PD-L1 expression', 'patients with non-small cell lung cancer (NSCLC) tumors', 'patients with advanced/metastatic NSCLC negative for PD-L1 ', 'patients with NSCLC', 'patients with advanced NSCLC', 'patients with previously untreated advanced/metastatic non-small cell lung cancer (NSCLC', 'Four hundred forty-four of the 1328 patients (33.4%) who were enrolled across the 3 trials had PD-L1-negative tumors (256 on pembrolizumab plus chemotherapy [nonsquamous, n\xa0=\xa0155; squamous, n\xa0=\xa094; other, n\xa0=\xa07] and 188 on chemotherapy alone [nonsquamous, n\xa0=\xa083; squamous, n\xa0=\xa099; other, n\xa0=\xa06']","['pembrolizumab', 'pembrolizumab plus chemotherapy', 'pembrolizumab plus chemotherapy versus chemotherapy alone', 'pembrolizumab plus chemotherapy (pemetrexed and platinum for nonsquamous histology and carboplatin and paclitaxel/nab-paclitaxel', 'chemotherapy alone', 'Pembrolizumab plus platinum-based chemotherapy', 'Pembrolizumab plus chemotherapy']","['3-year OS rate', 'immune-mediated AEs and infusion reactions', 'Adverse events (AEs', 'median time', 'progression-free survival', 'objective response rate', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C4087225', 'cui_str': 'Immune-mediated adverse reaction'}, {'cui': 'C2368034', 'cui_str': 'Adverse reaction to drug or medicament administered by infusion'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1328.0,0.416973,"Pembrolizumab plus chemotherapy improved overall survival (OS; hazard ratio [HR], 0.63; 95% CI, 0.50-0.79) and progression-free survival (HR, 0.68; 95% CI, 0.56-0.83) over chemotherapy.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Borghaei', 'Affiliation': 'Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Universidad Complutense and CIBERONC, Madrid, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodríguez-Abreu', 'Affiliation': 'Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Montefiore Einstein Center for Cancer Care, New York, New York.'}, {'ForeName': 'Marina C', 'Initials': 'MC', 'LastName': 'Garassino', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Baerin', 'Initials': 'B', 'LastName': 'Houghton', 'Affiliation': 'Mid North Coast Cancer Institute, Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Kurata', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'M Catherine', 'Initials': 'MC', 'LastName': 'Pietanza', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co, Inc, Kenilworth, New Jersey.'}, {'ForeName': 'Shirish M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Rogel Cancer Center, University of Michigan, Ann Arbor, Michigan.'}]",Cancer,['10.1002/cncr.33142']
2419,32914911,Shoulder MR Arthrography: Comparative Evaluation of Three Different Contrast Injection Techniques Using an Anterior Approach.,"BACKGROUND


MR arthrography (MRA) is commonly used in the assessment of shoulder internal derangements. Correct intra-articular contrast injection is required for this modality. Anterior injections under fluoroscopic, ultrasound-guidance, or without image-guidance have been described in the literature. However, no simultaneous comparison has been performed between the three techniques.
PURPOSE


To compare the accuracy and performance of fluoroscopy (FL)-guided, ultrasound (US)-guided and non-image-guided intra-articular contrast injection via an anterior approach for performing shoulder MRA.
STUDY TYPE


Prospective.
SUBJECTS


Two-hundred and ten patients (180 men and 30 women; mean age, 33 ± 12 years; range 20-60 years) with clinically suspected shoulder pathology.
FIELD STRENGTH/SEQUENCE


1.5T/fat-suppressed T 1  -weighted, T 2  -weighted, and 3D-gradient-echo images.
ASSESSMENT


Patients underwent shoulder MRA after anterior intra-articular contrast injection under FL- or US-guidance or without image-guidance. Patients were randomized among the three techniques with each group comprising 70. The techniques were compared according to the accuracy of intra-articular needle placement, attempts success rate, pain during and 24 hours after injection, procedure times, contrast extravasation rate, joint distension, and MRA diagnostic efficacy. Pain was assessed by the visual analog scale (VAS) pain-score.
STATISTICAL TESTS


Pearson's chi-squared and Kruskal-Wallis tests.
RESULTS


FL- and US-guided injections (100% accuracy) were significantly more accurate than non-image-guided (85.7% accuracy) (P < 0.05). US-guidance was the least painful, with statistical differences between image-guided and non-image-guided techniques regarding the first attempt success rate (95.7% and 92.8% for FL- and US-guided vs. 78.6% for blinded), VAS-score 24 hours-post-procedure (1.7 ± 1.7, and 1.5 ± 1.4 vs. 2.2 ± 1.4), procedure time (11.9 ± 1.6, and 7.4 ± 1.7 vs. 4.3 ± 0.76 minutes), and contrast extravasation rate (5.7%, and 8.6% vs. 30%) (all P < 0.05). Procedure time was also significantly different between FL and US-guidance (P < 0.05).
DATA CONCLUSION


Imaging-guided injections are more accurate and tolerable than non-image-guided and should be considered to confirm intra-articular needle position, hence adequate capsular distension and good diagnostic quality of shoulder MRA. US guidance is a less painful, rapid, and safe alternative to the FL approach. Evidence Level: 2 Technical Efficacy Stage: 5.",2020,"RESULTS


FL- and US-guided injections (100% accuracy) were significantly more accurate than non-image-guided (85.7% accuracy)","['Two-hundred and ten patients (180 men and 30 women; mean age, 33\u2009±\u200912\u2009years; range 20-60\u2009years) with clinically suspected shoulder pathology']","['fluoroscopy (FL)-guided, ultrasound (US)-guided and non-image-guided intra-articular contrast injection via an anterior approach', 'MR arthrography (MRA']","['visual analog scale (VAS) pain-score', 'contrast extravasation rate', 'success rate', 'Pain', 'Procedure time', 'procedure time', 'success rate, pain during and 24\u2009hours after injection, procedure times, contrast extravasation rate, joint distension, and MRA diagnostic efficacy']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}]","[{'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0003885', 'cui_str': 'Arthrography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",210.0,0.0306743,"RESULTS


FL- and US-guided injections (100% accuracy) were significantly more accurate than non-image-guided (85.7% accuracy)","[{'ForeName': 'Abeer H', 'Initials': 'AH', 'LastName': 'Ali', 'Affiliation': 'The Department of Diagnostic Radiology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hatem G', 'Initials': 'HG', 'LastName': 'Said', 'Affiliation': 'The Department of Orthopedic Surgery, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Abo Elhamd', 'Affiliation': 'The Department of Diagnostic Radiology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammad K', 'Initials': 'MK', 'LastName': 'Mahmoud', 'Affiliation': 'The Department of Diagnostic Radiology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Omran K', 'Initials': 'OK', 'LastName': 'Qenawy', 'Affiliation': 'The Department of Diagnostic Radiology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27348']
2420,32914914,"Efficacy of bismuth-based quadruple therapy for eradication of Helicobacter pylori infection based on previous antibiotic exposure: A large-scale prospective, single-center clinical trial in China.","OBJECTIVE


This study aims to evaluate the efficacy and safety of three bismuth-based quadruple regimens for eradication of Helicobacter pylori (H pylori) infection in a large number of H pylori-positive patients with or without previous eradication therapy.
METHODS


Consecutive adult patients with H pylori infection, regardless of previous eradication therapy, were eligible for the present study. Three bismuth-based quadruple regimens were selected according to the past history of antibiotics use: (A) esomeprazole, amoxicillin, clarithromycin, and colloidal bismuth tartrate; (B) esomeprazole, amoxicillin, furazolidone, and colloidal bismuth tartrate; and (C) esomeprazole, doxycycline, furazolidone, and colloidal bismuth tartrate. All patients received a 14-day course of treatment, and  13  C/ 14  C urea breath test was utilized at four weeks after the completion of treatment to determine the H pylori eradication. Then, the eradication rates were calculated in terms of intention-to-treat (ITT) and per-protocol (PP) analyses. Adverse events (AEs) were recorded during the treatment.
RESULTS


Overall, 1,226 patients were recruited, and 331, 57, and 838 patients were allocated to receive regimens A, B, and C, respectively. The H pylori eradication rates were 84.0%, 82.5%, and 82.9% (ITT) and 94.6%, 92.2%, and 93.7% (PP), respectively, in regimens A, B, and C. However, there was no significant difference among these three regimens. The incidence of AEs was 4.6% for all patients during the study, that is, 3.3%, 10.5%, and 4.7% for regimens A, B, and C, respectively. All AEs were mild and recovered at the follow-up visit.
CONCLUSION


All three bismuth-based quadruple regimens based on the previous antibiotic use can achieve satisfactory eradication rates for H pylori infection and are safe.",2020,"The H pylori eradication rates were 84.0%, 82.5%, and 82.9% (ITT) and 94.6%, 92.2%, and 93.7% (PP), respectively, in regimens A, B, and C.","['Consecutive adult patients with H pylori infection, regardless of previous eradication therapy, were eligible for the present study', 'H pylori-positive patients with or without previous eradication therapy', '1,226 patients were recruited, and 331, 57, and 838 patients']","['esomeprazole, amoxicillin, clarithromycin, and colloidal bismuth tartrate; (B) esomeprazole, amoxicillin, furazolidone, and colloidal bismuth tartrate; and (C) esomeprazole, doxycycline, furazolidone, and colloidal bismuth tartrate', 'bismuth-based quadruple therapy', 'bismuth-based quadruple regimens']","['incidence of AEs', 'Helicobacter pylori infection', 'eradication rates', 'efficacy and safety', 'Helicobacter pylori (H pylori) infection', 'Adverse events (AEs', 'H pylori eradication rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0053781', 'cui_str': 'bismoverol'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1226.0,0.0323817,"The H pylori eradication rates were 84.0%, 82.5%, and 82.9% (ITT) and 94.6%, 92.2%, and 93.7% (PP), respectively, in regimens A, B, and C.","[{'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shao-Peng', 'Initials': 'SP', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, The Third Xiangya Hospital, Central South University, Changsha, China.'}]",Helicobacter,['10.1111/hel.12755']
2421,32914917,Recruitment and retention of older adults in Assisted Living Facilities to a clinical trial using technology for falls prevention: A qualitative case study of barriers and facilitators.,"Older adults often have health complexities and higher levels of attrition. Even though they are the main users of healthcare, they are often not included in health research because the health research may not be well designed to accommodate their evolving health needs. One research area in which participation of older adults is essential focuses on improving physical function. In this field, there are many innovations and new technologies developed. Barriers and facilitators to recruit older adults to research that improves physical function by using technology are not well explored yet. This study aims to explore barriers and facilitators regarding recruitment and retention of older adults living in Assisted Living Facilities to a randomised controlled trial study that aimed to improve physical function by using technology. Nine semi-structured interviews were conducted with four Scheme Managers, three therapists and two researchers. The interviews were transcribed. After open, axial and selective coding, the codes were thematic analysed in ATLAS.ti. Scheme Managers, therapists, researchers and older adults' peers appear to play an important role in the recruitment and retention of older adults living in Assisted Living Facilities. Additionally, the technology itself and the presentation of the research appear to influence recruitment. Creating a social setting, inviting people face-to-face, demonstrating the technology, showing the benefits by presenting results from a pilot study and alleviating people's fears were experienced as important factors for recruitment. The results from this study can help other researcher to improve recruitment and retention strategies so evidence-based practice in care for older adults can be improved to enhance quality of life of older adults.",2020,This study aims to explore barriers and facilitators regarding recruitment and retention of older adults living in Assisted Living Facilities to a randomised controlled trial study that aimed to improve physical function by using technology.,"['older adults', 'Older adults', 'older adults living in Assisted Living Facilities']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",[],[],9.0,0.0918137,This study aims to explore barriers and facilitators regarding recruitment and retention of older adults living in Assisted Living Facilities to a randomised controlled trial study that aimed to improve physical function by using technology.,"[{'ForeName': 'Wytske M A', 'Initials': 'WMA', 'LastName': 'Meekes', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioural Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ford', 'Affiliation': 'School of Health Sciences, Jean McFarlane Building, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Stanmore', 'Affiliation': 'School of Health Sciences, Jean McFarlane Building, The University of Manchester, Manchester, UK.'}]",Health & social care in the community,['10.1111/hsc.13170']
2422,32914928,Interim Analysis of an Open-label Randomized Controlled Trial Evaluating Nasal Irrigations in Non-hospitalized Patients with COVID-19.,,2020,,['Non-hospitalized Patients with COVID-19'],[],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],[],,0.0720634,,"[{'ForeName': 'Kyle S', 'Initials': 'KS', 'LastName': 'Kimura', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Freeman', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Bronson C', 'Initials': 'BC', 'LastName': 'Wessinger', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Veerain', 'Initials': 'V', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Quanhu', 'Initials': 'Q', 'LastName': 'Sheng', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Li Ching', 'Initials': 'LC', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Von Wahlde', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, Division of Microbiology and Infectious Disease, Vanderbilt University School of Medicine, Nashville, TN, 37232, USA.'}, {'ForeName': 'Naweed I', 'Initials': 'NI', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}, {'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Turner', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Vanderbilt University Medical Center, Nashville, TN, 37232, USA.'}]",International forum of allergy & rhinology,['10.1002/alr.22703']
2423,32915004,Satisfied yet striving: Gratitude fosters life satisfaction and improvement motivation in youth.,"Could 10 min of gratitude per week have the potential to change the trajectories of young students' lives? With over 1,000 ninth- and tenth-grade students, we tested whether a simple 4-week classroom-based gratitude intervention would prompt increases in well-being and motivate students to become better people and attain better grades. Over the course of 1 month, students were assigned to spend 10 min each week writing gratitude letters to their parents, teachers, coaches, or friends and completing additional gratitude-related reflection activities or to try to become more organized each week by listing their daily activities and reflecting on the obstacles and benefits (control). Importantly, relative to controls, students in the gratitude conditions reported greater LS and motivation to improve themselves and maintained these levels throughout the semester. This sustained self-improvement motivation and LS were partially mediated by increases in feelings of connectedness, elevation, and indebtedness. Interestingly, negative affect partially mediated the effect of gratitude on LS, but not on improvement motivation. No group differences emerged in academic performance over time. This study provides evidence that expressing gratitude and reflecting on their benefactors' actions may help keep high school students motivated and satisfied with their lives over the course of a semester. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Importantly, relative to controls, students in the gratitude conditions reported greater LS and motivation to improve themselves and maintained these levels throughout the semester.","['With over 1,000 ninth- and tenth-grade students']",['simple 4-week classroom-based gratitude intervention'],"['feelings of connectedness, elevation, and indebtedness', 'LS and motivation', 'academic performance']","[{'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0205444', 'cui_str': 'Tenth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0581901', 'cui_str': 'In debt'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",,0.0215679,"Importantly, relative to controls, students in the gratitude conditions reported greater LS and motivation to improve themselves and maintained these levels throughout the semester.","[{'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Armenta', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Fritz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Lyubomirsky', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000896']
2424,32915009,The impact of a deliberate practice workshop on therapist demand and support behavior with community volunteers and simulators.,"The present study used a newly developed simplified coding system, the Therapist Demand and Support Code, to examine specific therapist behaviors in the context of a previously conducted training trial on Deliberate Practice (DP). The parent trial randomized trainees to a DP workshop or its Traditional, more didactic counterpart (Westra et al., 2020). In both groups, trainees were taught to use Support, rather than Demand, for managing ambivalence and resistance, with the DP group having more feedback and practice. In this study, 68 trainees interviewed both an ambivalent community volunteer and an ambivalent simulator 4 month post workshop. The DP group was found to exhibit significantly fewer Demand behaviors than the Traditional group, with the latter also being significantly quicker to use Demand in the interviews. Moreover, the simulator evoked significantly greater Demand from therapists, regardless of the Training group, suggesting the simulators were more resistant. Although therapist use of Support was equal for community volunteers across training groups, Traditional workshop trainees decreased Support when interviewing the more resistant simulators, whereas DP trainees increased their Support with this same group. This is consistent with findings that DP trainees were more appropriately responsive, making fewer Demands following interviewee counterchange talk and using more Support at these times. These results provide some initial validation of the simplified therapist behavior coding system and offer further evidence for the benefits of DP workshop training for managing resistance. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The DP group was found to exhibit significantly fewer Demand behaviors than the Traditional group, with the latter also being significantly quicker to use Demand in the interviews.",['68 trainees interviewed both an ambivalent community volunteer and an ambivalent simulator 4 month post workshop'],"['deliberate practice workshop', 'DP workshop training']",['Demand behaviors'],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0233495', 'cui_str': 'Feeling mixed emotions'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}]","[{'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0562447', 'cui_str': 'Demanding behavior'}]",,0.0183272,"The DP group was found to exhibit significantly fewer Demand behaviors than the Traditional group, with the latter also being significantly quicker to use Demand in the interviews.","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Shukla', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Alyssa A', 'Initials': 'AA', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Henny A', 'Initials': 'HA', 'LastName': 'Westra', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Olson', 'Affiliation': 'Department of Psychology, York University.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Shekarak Ghashghaei', 'Affiliation': 'Department of Psychology, York University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000333']
2425,32896264,Clinical efficacy of ultrasound-guided hyaluronic acid injections in patients with supraspinatus tendon tear.,"OBJECTIVES


To evaluate the clinical efficacy of ultrasound (US)-guided soft tissue adapted biocompatible hyaluronic acid (STABHA) injections in the subacromial-subdeltoid bursa of patients with supraspinatus tendon tear.
METHODS


In this prospective study, patients with a symptomatic partial-thickness or small full-thickness supraspinatus tendon tear, diagnosed by US, were consecutively enrolled. Patients received one injection at baseline visit and one after 2 weeks and performed rehabilitation therapy. Clinical assessment was performed with visual analogue scale (VAS) for pain, Constant-Murley Scale (CMS), and patient reported efficacy on a 0-4 Likert scale. Patients were examined at baseline, at week 2 and at week 12.
RESULTS


Thirty patients were enrolled. Sixteen (53.3%) and 19 (63.3%) patients reported significant improvement at week 12 in pain and function, respectively. Reduction in VAS pain was statistically significant both at week 2 and at week 12 in comparison with baseline visit (mean-difference -27.2 and -36.8, respectively, p<0.01). The same trend was observed with CMS (mean-difference 17.7 and 19.8, respectively, p<0.01). At week 12, 18 patients (60.0%) reported a subjective improvement. At week 12, in non-responders (n=14) US detected inflammatory changes and/or progression of tendon tear in 7 (50.0%) patients and no relevant changes in 7 (50.0%).
CONCLUSIONS


US-guided STABHA injections followed by rehabilitation therapy were found effective in improving both pain and shoulder function at the 12-week follow-up. In half of the non-responders, US allowed the detection of US findings responsible for treatment failure.",2020,"Reduction in VAS pain was statistically significant both at week 2 and at week 12 in comparison with baseline visit (mean-difference -27.2 and -36.8, respectively, p<0.01).","['patients with supraspinatus tendon tear', 'patients with a symptomatic partial-thickness or small full-thickness supraspinatus tendon tear, diagnosed by US, were consecutively enrolled', 'Thirty patients were enrolled']","['ultrasound-guided hyaluronic acid injections', 'ultrasound (US)-guided soft tissue adapted biocompatible hyaluronic acid (STABHA) injections', 'rehabilitation therapy']","['pain and shoulder function', 'visual analogue scale (VAS) for pain, Constant-Murley Scale (CMS', 'inflammatory changes and/or progression of tendon tear', 'VAS pain', 'subjective improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0443275', 'cui_str': 'Partial thickness'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",30.0,0.0241916,"Reduction in VAS pain was statistically significant both at week 2 and at week 12 in comparison with baseline visit (mean-difference -27.2 and -36.8, respectively, p<0.01).","[{'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Cipolletta', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, ""Carlo Urbani"" Hospital, Jesi, Italy. edoardocipolletta@gmail.com.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Mashadi Mirza', 'Affiliation': 'Radiology Department, A.O. Ospedali Riuniti Marche Nord, Pesaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Di Matteo', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, ""Carlo Urbani"" Hospital, Jesi, Italy; and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Di Carlo', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, ""Carlo Urbani"" Hospital, Jesi, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Grassi', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, ""Carlo Urbani"" Hospital, Jesi, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Filippucci', 'Affiliation': 'Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, ""Carlo Urbani"" Hospital, Jesi, Italy.'}]",Clinical and experimental rheumatology,[]
2426,32896292,Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial.,"BACKGROUND


The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19.
METHODS


We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.gov, NCT04321278.
FINDINGS


447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94-1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
INTERPRETATION


In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.
FUNDING


COALITION COVID-19 Brazil and EMS.",2020,"Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
","['patients with severe COVID-19', '57 centres in Brazil', '447 patients were enrolled from March 28 to May 19, 2020', '397 patients who constituted the mITT population', 'enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of', 'patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II', 'population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation ', 'patients admitted to the hospital with severe COVID-19']","['hydroxychloroquine', 'azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides', 'oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation', 'azithromycin', 'Azithromycin', 'invasive mechanical ventilation']","['intention-to-treat (ITT', 'Safety', 'Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",447.0,0.343065,"Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.
","[{'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Instituto do Coração, Hospital das Clinicas da Faculdade de Medicina, Universidade de São Paulo, Brazil.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: otavio.berwanger@einstein.br.'}, {'ForeName': 'Henrique A', 'Initials': 'HA', 'LastName': 'Fonseca', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Thiago D', 'Initials': 'TD', 'LastName': 'Corrêa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Brazilian Research in Intensive Care Network, São Paulo, Brazil.'}, {'ForeName': 'Leonardo R', 'Initials': 'LR', 'LastName': 'Ferraz', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Maura G', 'Initials': 'MG', 'LastName': 'Lapa', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Hospital Sírio Libanês Research and Education Institute, São Paulo, Brazil.'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil; Duke University Medical Centre, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Airton L O', 'Initials': 'ALO', 'LastName': 'Manoel', 'Affiliation': 'Hospital Moyses Deustche (MBoi Mirim), São Paulo, Brazil.'}, {'ForeName': 'Felipe M T', 'Initials': 'FMT', 'LastName': 'Piza', 'Affiliation': 'Hospital Moyses Deustche (MBoi Mirim), São Paulo, Brazil.'}, {'ForeName': 'Priscilla A', 'Initials': 'PA', 'LastName': 'Martins', 'Affiliation': 'Hospital Estadual Jayme dos Santos Neves, Serra, Brazil.'}, {'ForeName': 'Thiago C', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Hospital de Clínicas, Porto Alegre, Brazil.'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Vila Santa Catarina, São Paulo, Brazil.'}, {'ForeName': 'Guilherme B', 'Initials': 'GB', 'LastName': 'Olivato', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Hospital Vila Santa Catarina, São Paulo, Brazil.'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'Hospital Naval Marcílio Dias, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'Hospital Giselda Trigueiro, Natal, Brazil.'}, {'ForeName': 'Otavio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'Hospital Santa Paula, São Paulo, Brazil.'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'EMS Pharma, Hortolândia, Brazil.'}, {'ForeName': 'Monalisa B', 'Initials': 'MB', 'LastName': 'Oliveira', 'Affiliation': 'EMS Pharma, Hortolândia, Brazil.'}, {'ForeName': 'Ronaldo V P', 'Initials': 'RVP', 'LastName': 'Soares', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Diogo D F', 'Initials': 'DDF', 'LastName': 'Moia', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Luciana P A', 'Initials': 'LPA', 'LastName': 'Piano', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Kleber', 'Initials': 'K', 'LastName': 'Castilho', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Roberta G R A P', 'Initials': 'RGRAP', 'LastName': 'Momesso', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Guilherme P P', 'Initials': 'GPP', 'LastName': 'Schettino', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Luiz Vicente', 'Initials': 'LV', 'LastName': 'Rizzo', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Ary Serpa', 'Initials': 'AS', 'LastName': 'Neto', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil; Brazilian Research in Intensive Care Network, São Paulo, Brazil; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; Department of Anesthesiology, Pain and Intensive Care Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Brazilian Research in Intensive Care Network, São Paulo, Brazil; HCor Research Institute, São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31862-6']
2427,32896294,"Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial.","BACKGROUND


Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes.
METHODS


In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants.
FINDINGS


Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints.
INTERPRETATION


Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery.
FUNDING


UK National Institute of Health Research Health Technology Assessment Program.",2020,"There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93).","['487 participants randomly assigned to', 'patients undergoing major elective surgery', 'patients with anaemia 10-42 days before elective major abdominal surgery', 'adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres', 'anaemic patients before major open elective abdominal surgery']","['secure web-based service to receive intravenous iron or placebo', 'placebo', 'Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT', 'ferric carboxymaltose in 100 mL normal saline, and placebo']","['blood transfusions', 'risk of the composite outcome of blood transfusion or death, and number of blood transfusions', 'Anaemia', 'Death or blood transfusion']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",487.0,0.805107,"There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93).","[{'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Richards', 'Affiliation': 'Division of Surgery, University of Western Australia, Fiona Stanley Hospital, Perth, WA, Australia; Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK. Electronic address: toby.richards@uwa.edu.au.'}, {'ForeName': 'Ravishankar Rao', 'Initials': 'RR', 'LastName': 'Baikady', 'Affiliation': 'Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Clevenger', 'Affiliation': 'Department of Anaesthesia, Royal National Orthopaedic Hospital, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Butcher', 'Affiliation': 'Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Abeysiri', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Chau', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Macdougall', 'Affiliation': ""Department of Renal Medicine, King's College Hospital, London, UK.""}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Murphy', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Swinson', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Collier', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Van Dyck', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Browne', 'Affiliation': 'School of Public Health, University College Cork, Cork, Ireland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'University Department of Vascular Surgery, Birmingham University, Solihull Hospital, Solihull, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dodd', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brealey', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK; Division of Surgery, University College London, London, UK.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies, and German Centre for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Royal Papworth Hospital, Cambridge, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31539-7']
2428,32896359,Perception of vocal emotional prosody in children with hearing impairment.,"PURPOSE


The study aimed at testing the effect of supra segmental training on vocal emotional prosody perception of children with hearing impairment. The objectives of the study were to compare the perception of vocal emotional prosody (happy, sad, and neutral) in children with hearing impairment with and without a short-term prosody training and to draw correlations between the vocal emotional prosody perception scores and the subject factors - chronological age, age of hearing aid fitting, duration of the intensive intervention (speech, language and auditory training without breaks more than 30 days) and language age in children with hearing impairment.
METHOD


Thirty children with hearing impairment in the age range of 4.1-9.2 years with a language age of 3-7 years participated in the study. The authors formulated 24 concrete Malayalam sentences and their picture representations and these were recorded under three emotional variations (happy, sad, and neutral). Using random sampling, the thirty participants were divided into the control group (CWHI) and the experimental (CWHIt) group. The study was carried out in two phases; phase 1 (training) attended by only the experimental group and phase 2 (testing) attended by both the groups.
RESULTS


There was a significant difference between CWHI and CWHIt in the happy, sad, and neutral vocal emotional prosody conditions. Chronological age, duration of speech-language-auditory training, and language age showed a positive correlation with the vocal emotional prosody perception scores; and no correlation was found between the age of fitting of hearing aids and the emotion perception scores.
CONCLUSION


The results of the study points out that with adequate prosody training, the children with hearing impairment using benefiting hearing aids could improve their vocal emotional prosody perception. Owing to the role of prosody perception in speech & language, social and cognitive development, the supra segmental training should be made an integral part of the assessment and management intervention strategies.",2020,"There was a significant difference between CWHI and CWHIt in the happy, sad, and neutral vocal emotional prosody conditions.","['children with hearing impairment using benefiting hearing aids', 'two phases; phase 1 (training) attended by only the experimental group and phase 2 (testing) attended by both the groups', 'children with hearing impairment with and without a short-term prosody training and to draw correlations between the vocal emotional prosody perception scores and the subject factors - chronological age, age of hearing aid fitting, duration of the intensive intervention (speech, language and auditory training without breaks more than 30 days) and language age in children with hearing impairment', 'Thirty children with hearing impairment in the age range of 4.1-9.2 years with a language age of 3-7 years participated in the study', 'children with hearing impairment']","['adequate prosody training', 'supra segmental training']","['CWHI and CWHIt in the happy, sad, and neutral vocal emotional prosody conditions', 'Chronological age, duration of speech-language-auditory training', 'vocal emotional prosody perception scores', 'perception of vocal emotional prosody (happy, sad, and neutral', 'vocal emotional prosody perception', 'Perception of vocal emotional prosody']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0233743', 'cui_str': 'Prosody'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0200318', 'cui_str': 'Fitting of hearing aid'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0233743', 'cui_str': 'Prosody'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233743', 'cui_str': 'Prosody'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0127331,"There was a significant difference between CWHI and CWHIt in the happy, sad, and neutral vocal emotional prosody conditions.","[{'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Yeshoda', 'Affiliation': 'All India Institute of Speech and Hearing, Manasagangothri, Mysore, 570 006, India. Electronic address: yeshoda.krishna@gmail.com.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Raveendran', 'Affiliation': 'All India Institute of Speech and Hearing, Manasagangothri, Mysore, 570 006, India. Electronic address: revathirslp@gmail.com.'}, {'ForeName': 'Sreeraj', 'Initials': 'S', 'LastName': 'Konadath', 'Affiliation': 'All India Institute of Speech and Hearing, Manasagangothri, Mysore, 570 006, India. Electronic address: sreerajkonadath@aiishmysore.in.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110252']
2429,32896387,Re: Prajna et al.: Cross-Linking-Assisted Infection Reduction: a randomized clinical trial evaluating the effect of adjuvant cross-linking on outcomes in fungal keratitis (Ophthalmology. 2020;127:159-166).,,2020,,['fungal keratitis (Ophthalmology'],"['adjuvant cross-linking', ' Cross-Linking-Assisted Infection Reduction']",[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],,0.139189,,"[{'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Singhal', 'Affiliation': 'Institute of Vision and Optics, VEIC, University of Crete, Greece.'}, {'ForeName': 'Prafulla K', 'Initials': 'PK', 'LastName': 'Maharana', 'Affiliation': 'Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India. Electronic address: drpraful13@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.07.010']
2430,32896466,Surgical outcomes of percutaneous transhepatic gallbladder drainage in acute cholecystitis grade II patients according to time of surgery.,"BACKGROUND


The objective of this study was to determine the appropriate timing for surgical intervention for Grade II acute cholecystitis patients. The study compares the clinical outcomes of patients in Group A, who were treated with early laparoscopic cholecystectomy (ELC) within the first two weeks of hospitalization, and Group B, treated with delayed laparoscopic cholecystectomy (DLC) after recovering from symptoms and that received conservative treatment and were discharged for more than two weeks.
METHODS


From November 2011 to June 2019, from a total of 196 acute cholecystitis patients that received percutaneous transhepatic gallbladder drainage (PTGBD) insertion, we conducted a retrospective review of the group that received early laparoscopic cholecystectomy within 2 weeks and the group that received delayed laparoscopic cholecystectomy. The clinical characteristics and post-treatment outcomes were evaluated.
RESULTS


In all patients treated with PTGBD insertion, Group A, the patients who were treated with ELC, showed a significantly longer mean operative time than Group B, the patients who were treated with DLC (72.46 ± 46.396 vs. 54.08 ± 27.12, P = 0.001). Similarly, Group A showed a significantly longer postoperative hospital stay compared to Group B (5.71 ± 5.062 vs. 4.27 ± 2.931, P = 0.014).
CONCLUSION


In patients with Grade II acute cholecystitis with PTGBD insertion, DLC produces better outcomes with shorter hospital stay and operative time than ELC. These results suggest that DLC may lead to a better outcome than ELC, specifically when deciding the timing for laparoscopic cholecystectomy in patients diagnosed with acute Grade II cholecystitis.",2020,"In patients with Grade II acute cholecystitis with PTGBD insertion, DLC produces better outcomes with shorter hospital stay and operative time than ELC.","['patients diagnosed with acute Grade II cholecystitis', 'acute cholecystitis grade II patients according to time of surgery', 'From November 2011 to June 2019, from a total of 196 acute cholecystitis patients that received', 'Grade II acute cholecystitis patients', 'patients with Grade II acute cholecystitis with PTGBD insertion']","['early laparoscopic cholecystectomy (ELC', 'delayed laparoscopic cholecystectomy (DLC', 'ELC', 'laparoscopic cholecystectomy', 'delayed laparoscopic cholecystectomy', 'percutaneous transhepatic gallbladder drainage (PTGBD) insertion', 'percutaneous transhepatic gallbladder drainage', 'DLC', 'surgical intervention', 'early laparoscopic cholecystectomy']","['mean operative time', 'postoperative hospital stay', 'hospital stay and operative time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0008325', 'cui_str': 'Cholecystitis'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",196.0,0.067332,"In patients with Grade II acute cholecystitis with PTGBD insertion, DLC produces better outcomes with shorter hospital stay and operative time than ELC.","[{'ForeName': 'Hye Woen', 'Initials': 'HW', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Uk', 'Initials': 'KU', 'LastName': 'Jung', 'Affiliation': 'Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mi Yeon', 'Initials': 'MY', 'LastName': 'Lee', 'Affiliation': 'Division of Biostatistics, Department of R&D Management, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Pyo', 'Initials': 'HP', 'LastName': 'Hong', 'Affiliation': 'Department of Radiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Ryol', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: sungryol.lee@samsung.com.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.08.008']
2431,32896498,Aqueous Cytokine Expression and Higher-Order OCT Biomarkers: Assessment of the Anatomic-Biologic Bridge in the IMAGINE DME Study.,"PURPOSE


To identify biomarkers for predicting response to anti-VEGF therapy in diabetic macular edema (DME) and evaluate any links between cytokine expression and OCT phenotype.
DESIGN


IMAGINE DME is a post-hoc image analysis and cytokine expression assessment of the DAVE randomized clinical trial.
METHODS


Subjects were categorized as anatomical Responders or Nonresponders,and within the Responder group as Rebounders and Nonrebounders based on quantitative, longitudinal optical coherence tomography (OCT) criteria. Retinal layer and fluid features were extracted using an OCT machine-learning augmented segmentation platform. Responders were further sub-classified by rapidity of response. Aqueous concentrations of 54 cytokines at multiple timepoints. Expression was compared between Responder groups and correlated with OCT imaging biomarkers.
RESULTS


Of the 24 eyes studied, 79% were anatomical Responders with 38% Super Responders, 17% Early Responders, 25% Slow Responders. Twenty-one percent were Nonresponders. Super Responders had increased baseline VEGF (880.0 vs 245.4 pg/mL, p=0.012) and decreased MCP-1 (513.3 vs 809.5 pg/mL, 0.042) concentrations compared to Nonresponders. IL-6 (-24.9 vs 442.8 pg/mL, p=0.032) concentrations increased among Nonresponders during therapy. VEGF concentrations correlated with central subfield thickness (r=0.49, p=0.01). Panmacular retinal volume correlated with increased IL-6 (r=0.47, p=0.02) and decreased MCP-1 (r=-0.45, p=0.03). MMP-1 correlated with SRF volume (r=0.50, p=0.01).
CONCLUSIONS


OCT imaging biomarkers correlated with both intraocular cytokines and responsiveness to anti-VEGF therapy, indicating a possible link to underlying pathways and their relevance to DME prognosis. Baseline concentrations of VEGF and MCP-1 are associated with anatomic response to anti-VEGF therapy.",2020,"Super Responders had increased baseline VEGF (880.0 vs 245.4 pg/mL, p=0.012) and decreased MCP-1 (513.3 vs 809.5 pg/mL, 0.042) concentrations compared to Nonresponders. IL-6","['24 eyes studied', 'Subjects were categorized as anatomical Responders or Nonresponders,and within the Responder group as Rebounders and Nonrebounders based on quantitative, longitudinal optical coherence tomography (OCT) criteria', 'diabetic macular edema (DME']","['IL-6', 'anti-VEGF therapy']","['MCP-1', 'baseline VEGF', 'SRF volume', 'Panmacular retinal volume correlated with increased IL-6', 'VEGF concentrations', 'Expression']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}]","[{'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",79.0,0.043668,"Super Responders had increased baseline VEGF (880.0 vs 245.4 pg/mL, p=0.012) and decreased MCP-1 (513.3 vs 809.5 pg/mL, 0.042) concentrations compared to Nonresponders. IL-6","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Abraham', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland OH.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Houston TX; Blanton Eye Institute, Houston Methodist Hospital, Houston TX.'}, {'ForeName': 'Sruthi', 'Initials': 'S', 'LastName': 'Arepalli', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland OH; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland OH.'}, {'ForeName': 'Leina', 'Initials': 'L', 'LastName': 'Lunasco', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland OH.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Houston TX.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Quantitative Health Sciences, Cleveland Clinic, Cleveland OH.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Reese', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland OH.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland OH; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland OH.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Houston TX; Blanton Eye Institute, Houston Methodist Hospital, Houston TX.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland OH; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland OH. Electronic address: ehlersj@ccf.org.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.047']
2432,32896504,"Early, short-term, low-dose glucocorticoid therapy effectively blocks progression of severe acute exacerbation of chronic hepatitis B to liver failure.","OBJECTIVE


To determine whether early, short-term, low-dose glucocorticoid treatment prevents the progression of severe acute exacerbation of chronic hepatitis B to liver failure.
METHODS


We prospectively enrolled 125 patients with severe acute exacerbation of chronic hepatitis B from the Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University between September 2013 and March 2016. The patients were randomized to a hormone group (3-day, low-dose glucocorticoid treatment plus conventional treatment; 63 patients) and a control group (conventional treatment only; 62 patients). We analyzed markers of liver function, complications, mortality rates, and duration and cost of hospitalization.
RESULTS


Serum alanine transaminase levels were significantly lower in the hormone group than in the control group at 3 days (P = 0.009) and 1 week (P = 0.018) after treatment. The decrease in this level from the baseline value on day 3 was greater in the hormone group than in the control group (P = 0.023). The trend of the changes in this level significantly differed between the two groups (P = 0.008). The incidence of liver failure (8.06% vs. 30.16%; P = 0.002) and the duration of hospitalization (23.79 vs. 31.79 days; P = 0.031) were significantly lower in the hormone group than in the control group.
CONCLUSION


Low-dose, short-term glucocorticoid treatment early in the course of severe acute exacerbation of chronic hepatitis B along with conventional treatment significantly reduced the risk of progression to liver failure and shortened the duration of hospitalization, without increasing the complication rate.",2020,"The incidence of liver failure (8.06% vs. 30.16%; P = 0.002) and the duration of hospitalization (23.79 vs. 31.79 days; P = 0.031) were significantly lower in the hormone group than in the control group.
","['chronic hepatitis B to liver failure', '125 patients with severe acute exacerbation of chronic hepatitis B from the Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-sen University between September 2013 and March 2016']","['glucocorticoid therapy', 'hormone group (3-day, low-dose glucocorticoid treatment plus conventional treatment; 63 patients) and a control group (conventional treatment', 'glucocorticoid treatment']","['liver function, complications, mortality rates, and duration and cost of hospitalization', 'duration of hospitalization', 'Serum alanine transaminase levels', 'complication rate', 'incidence of liver failure', 'risk of progression to liver failure']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",125.0,0.0242439,"The incidence of liver failure (8.06% vs. 30.16%; P = 0.002) and the duration of hospitalization (23.79 vs. 31.79 days; P = 0.031) were significantly lower in the hormone group than in the control group.
","[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhe-Bin', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Ke', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Zhi-Shuo', 'Initials': 'ZS', 'LastName': 'Mo', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhen', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yu-Bao', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China.'}, {'ForeName': 'Gao', 'Initials': 'G', 'LastName': 'Zhi-Liang', 'Affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou City, 510630, PR China. Electronic address: gaozl@mail.sysu.edu.cn.'}]",Clinics and research in hepatology and gastroenterology,['10.1016/j.clinre.2020.07.010']
2433,32896527,"Early visual cortex response for sound in expert blind echolocators, but not in early blind non-echolocators.","Echolocation is a perceptual and navigational skill that can be acquired by some individuals. Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes. Expert human echolocators benefit from using this technique not only in controlled environments but also in their everyday lives. In the current study, we investigate the effect of echolocation on blind people's auditory spatial abilities at the cortical level. In an auditory spatial bisection task, we tested people who are early blinds and early blind expert echolocators, along with sighted people. Our results showed that there is similar early activation (50-90 ms) in the posterior area of the scalp for both early blind expert echolocators and sighted participants, but not in the early blind group. This activation was related to sound stimulation, and it is contralateral to the position of the sound in space. These findings indicate that echolocation is a good substitute for the visual modality that enables the development of auditory spatial representations when vision is not available.",2020,"Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes.","['people who are early blinds and early blind expert echolocators, along with sighted people']",['echolocation'],['Early visual cortex response'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0013529', 'cui_str': 'Echolocation'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}]",,0.0717283,"Regarding blind people, this skill can help them ""see"" the environment around them via a new form of auditory information based on echoes.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Tonelli', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy; Department of Translational Research of New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy. Electronic address: tonelli.alessia@gmail.com.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Campus', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gori', 'Affiliation': 'UVIP, Unit for Visually Impaired People, Istituto Italiano di Tecnologia, Genova, Italy.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107617']
2434,32896753,Proprioceptive neuromuscular facilitation in the functionality and lymphatic circulation of the upper limb of women undergoing breast cancer treatment.,"BACKGROUND


With the increase in survival of women treated for breast cancer, it is necessary to evaluate the effect of therapeutic resources on co-morbidities resulting from the surgical treatment of the disease. The aim of this study was to evaluate the effects of proprioceptive neuromuscular facilitation on the functionality and lymphatic circulation of the upper limb involved in the treatment of breast cancer.
METHODS


The study was conducted according to randomized clinical trial design. Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment, divided into two groups, control - women submitted to standard breast cancer treatment, and treated group, composed of women who underwent breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique. Palmar grip strength with dynamometer and shoulder range of motion with goniometer were evaluated. Lymphatic circulation analysis was performed in a computerized scintillation chamber, before and after therapeutic intervention.
FINDINGS


In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
INTERPRETATION


The results obtained in this study allow us to conclude that proprioceptive neuromuscular facilitation favors an increase in muscle strength, range of motion, but not in lymphatic flow, in women undergoing surgical treatment for breast cancer.",2020,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","['women undergoing surgical treatment for breast cancer', 'women undergoing breast cancer treatment', 'Thirty-two women at a mean age of 52.20 (±8.32) years, submitted to breast cancer treatment']","['proprioceptive neuromuscular facilitation', 'Proprioceptive neuromuscular facilitation', 'breast cancer treatment and rehabilitation with the proprioceptive neuromuscular facilitation technique', 'control - women submitted to standard breast cancer treatment']","['muscle strength, range of motion', 'palmar grip strength', 'internal rotation', 'lymphatic flow', 'range of motion of flexion', 'Palmar grip strength with dynamometer and shoulder range of motion with goniometer', 'external rotation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0454481', 'cui_str': 'Proprioceptive neuromuscular facilitation technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0575813', 'cui_str': 'Palmar grip'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}]",32.0,0.0146829,"In the results obtained, a significant increase (p < 0.05) of palmar grip strength was observed, a significant increase in range of motion of flexion (p < 0.001), extension (p < 0.0012), abduction (p < 0.0001), external rotation (p < 0.0001), internal rotation (p < 0.0001), and not significant for lymphatic flow (p > 0.05).
","[{'ForeName': 'Daniela Santana Polati', 'Initials': 'DSP', 'LastName': 'da Silveira', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil. Electronic address: daniela.silveira@unifran.edu.br.'}, {'ForeName': 'Marcelo José', 'Initials': 'MJ', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Nuclear Medicine, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Eduardo Tinóis', 'Initials': 'ET', 'LastName': 'da Silva', 'Affiliation': 'Departament of Physics in Nuclear Medicine, Radiation Safety and Technology Institute, Campinas, SP, Brazil.'}, {'ForeName': 'Almir José', 'Initials': 'AJ', 'LastName': 'Sarri', 'Affiliation': 'Departament of Physiotherapy, Câncer Hospital of Barretos, Barretos, SP, Brazil.'}, {'ForeName': 'Lais Mara Siqueira', 'Initials': 'LMS', 'LastName': 'das Neves', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Elaine Caldeira de Oliveira', 'Initials': 'ECO', 'LastName': 'Guirro', 'Affiliation': 'Postgraduate Program in Rehabilitation and Functional Performance, São Paulo University, Ribeirão Preto, São Paulo, Brazil; Department of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, SP, Brazil. Electronic address: ecguirro@fmrp.usp.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105158']
2435,32896775,Association of C-reactive protein and metabolic risk with cognitive effects of lurasidone in patients with schizophrenia.,"BACKGROUND


Accumulating evidence has implicated insulin resistance and inflammation in the pathophysiology of cognitive impairments associated with neuropsychiatric disorders. This post-hoc analysis based on a placebo-controlled trial investigated the effect of inflammation (indexed by CRP) and metabolic risk factors on cognitive performance in patients with schizophrenia treated with lurasidone.
METHODS


Acutely exacerbated patients with schizophrenia were randomized to lurasidone (80 or 160 mg/day), quetiapine XR 600 mg/day, or placebo. A wide range CRP test and a cognitive assessment using the CogState computerized battery were performed at baseline and week 6 study endpoint. Associations between log-transformed CRP, high density lipoprotein (HDL), homeostatic model assessment of insulin resistance (HOMA-IR) and treatment response were evaluated.
RESULTS


CRP combined with HDL, triglyceride-to-HDL (TG/HDL) ratio, or HOMA-IR at study baseline were significant moderators of the improvement in cognitive performance associated with lurasidone 160 mg/day (vs. placebo) treatment (p < .05). Greater placebo-corrected treatment effect size on the CogState composite score was observed for patients in the lurasidone 160 mg/day treatment group who had either low CRP and high HDL (d = 0.43), or low CRP and low HOMA-IR (d = 0.46). Interactive relationships between CRP, HDL, TG/HDL, HOMA-IR and the antipsychotic efficacy of lurasidone or quetiapine XR were not significant. There were no significant associations between antipsychotic treatment and changes in CRP level at study endpoint.
CONCLUSIONS


Findings of this post-hoc analysis based on a placebo-controlled trial in patients with schizophrenia suggest that baseline CRP level combined with measures of metabolic risk significantly moderated the improvement in cognitive performance associated with lurasidone 160 mg/day (vs. placebo) treatment. Our findings underscore the importance of maintaining a low metabolic risk profile in patients with schizophrenia.",2020,"Greater placebo-corrected treatment effect size on the CogState composite score was observed for patients in the lurasidone 160 mg/day treatment group who had either low CRP and high HDL (d = 0.43), or low CRP and low HOMA-IR (d = 0.46).","['patients with schizophrenia', 'patients with schizophrenia treated with lurasidone', 'Acutely exacerbated patients with schizophrenia']","['lurasidone', 'placebo', 'quetiapine XR 600\xa0mg/day, or placebo']","['cognitive performance', 'CogState composite score', 'Interactive relationships between CRP, HDL, TG/HDL, HOMA-IR and the antipsychotic efficacy of lurasidone or quetiapine XR', 'CRP combined with HDL, triglyceride-to-HDL (TG/HDL) ratio, or HOMA-IR', 'log-transformed CRP, high density lipoprotein (HDL), homeostatic model assessment of insulin resistance (HOMA-IR) and treatment response', 'CRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0994819,"Greater placebo-corrected treatment effect size on the CogState composite score was observed for patients in the lurasidone 160 mg/day treatment group who had either low CRP and high HDL (d = 0.43), or low CRP and low HOMA-IR (d = 0.46).","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry and Health Behavior, Augusta University, Augusta, GA, United States of America. Electronic address: brmiller@augusta.edu.'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}, {'ForeName': 'Cynthia O', 'Initials': 'CO', 'LastName': 'Siu', 'Affiliation': 'COS and Associates Ltd., Central, Hong Kong.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Thriving Mind South Florida, Miami, FL, United States of America; Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA and Fort Lee, NJ, United States of America.'}]",Comprehensive psychiatry,['10.1016/j.comppsych.2020.152195']
2436,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND


The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS


In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS


Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS


Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
2437,32896932,"Comparative Effectiveness of 755-nm Picosecond Laser, 755- and 532-nm Nanosecond Lasers for Treatment of Café-au-Lait Macules (CALMs): A Randomized, Split-Lesion Clinical Trial.","BACKGROUND AND OBJECTIVES


Many types of lasers have been used to treat café-au-lait macules (CALMs) since the introduction of the selective photothermolysis theory. However, the efficacy and safety of picosecond lasers, compared with those of nanosecond lasers, have not been researched. To compare the efficacy and safety of 755 nm picosecond laser (PS-755 nm), Q-switched (QS) Alexandrite 755 nm nanosecond laser (QS-755 nm), and QS Nd:YAG 532 nm nanosecond laser (QS-532 nm) for treating CALMs.
STUDY DESIGN/MATERIALS AND METHODS


Forty-one patients received several treatments at 3-month intervals. Lesions were divided into two or three approximately equal parts, which were randomly treated with PS-755 nm, QS-755 nm, and QS-532 nm. The safety and efficacy of three lasers were determined based on blinded visual assessments and self-reports of patients three months after the comparative trial.
RESULTS


Visual assessment 3 months after the comparative trial revealed that there was no statistically significant difference among the sites treated by QS-755 nm (2.84 ± 1.11), QS-532 nm (2.63 ± 1.06), and PS-755 nm (2.74 ± 1.05) lasers. Five (26.32%) of 19 patients showed lesion recurrence. Adverse effects included acneiform miliaris, hypopigmentation, and hyperpigmentation, which were resolved within 12 months. Five (26.32%) of 19 patients who showed lesion recurrence 1-5 months after laser treatment had lightened or cleared at least 50% of the lesion. 46.67% of patients were satisfied or very satisfied with the outcome of the overall treatment.
CONCLUSIONS


PS-755 nm, QS-755 nm, and QS-532 nm laser treatments were equally effective in treating and improving CALMs. PS-755 nm caused fewer adverse effects. Individuals can react differently to different types of lasers. Patch tests should be conducted before the treatment. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,"RESULTS


Visual assessment 3 months after the comparative trial revealed that there was no statistically significant difference among the sites treated by QS-755 nm (2.84 ± 1.11), QS-532 nm (2.63 ± 1.06), and PS-755 nm (2.74 ± 1.05) lasers.","['Café-au-Lait Macules (CALMs', 'Forty-one patients received several treatments at 3-month intervals']","['nm nanosecond laser (QS-755\u2009nm), and QS Nd:YAG 532\u2009nm nanosecond laser (QS-532\u2009nm', 'PS-755\u2009nm, QS-755\u2009nm, and QS-532\u2009nm', '755\u2009nm picosecond laser (PS-755\u2009nm), Q-switched (QS) Alexandrite 755', 'picosecond lasers', '755-nm Picosecond Laser, 755- and 532-nm Nanosecond Lasers']","['acneiform miliaris, hypopigmentation, and hyperpigmentation', 'efficacy and safety', 'lesion recurrence', 'safety and efficacy', 'adverse effects']","[{'cui': 'C0332573', 'cui_str': 'Macule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0675767', 'cui_str': 'alexandrite'}]","[{'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.036735,"RESULTS


Visual assessment 3 months after the comparative trial revealed that there was no statistically significant difference among the sites treated by QS-755 nm (2.84 ± 1.11), QS-532 nm (2.63 ± 1.06), and PS-755 nm (2.74 ± 1.05) lasers.","[{'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Cen', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shang', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Rao', 'Affiliation': ""Department of Pathology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Jiafang', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Xianglei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Hanru', 'Initials': 'H', 'LastName': 'Ying', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, No. 639 Zhizaoju Road, Shanghai, Shanghai, 200011, PR China.""}]",Lasers in surgery and medicine,['10.1002/lsm.23316']
2438,32915207,Getting to the Heart of the Matter in Later Life: The Central Role of Affect in Health Message Framing.,"BACKGROUND AND OBJECTIVES


Adopting healthy behaviors is often influenced by message framing; gain-framed messages emphasize the benefits of engaging in a behavior, whereas loss-framed messages highlight the consequences of not engaging in a behavior. Research has begun to uncover the underlying affective pathways involved in message framing. In the current study, we examined the role of affect in message framing to encourage physical exercise program enrollment among older adults.
RESEARCH DESIGN AND METHODS


We mailed flyers to 126 volunteers assigned to a gain- or loss-framed condition and measured their affective reactions to the flyer and enrollment intentions. After the call, participants had the opportunity to contact us to enroll.
RESULTS


Gain- versus loss-framing led to more positive affect toward the flyer, which predicted intentions and enrollment. In indirect-effect analyses, frame indirectly influenced intentions and enrollment via positive affect.
DISCUSSION AND IMPLICATIONS


Although message framing plays an indirect role in influencing behavior, affect plays a central role.",2020,"RESULTS


Gain- versus loss-framing led to more positive affect toward the flyer, which predicted intentions and enrollment.","['older adults', 'We mailed flyers to 126 volunteers assigned to a gain- or loss-framed condition and measured their affective reactions to the flyer and enrollment intentions']",['physical exercise program enrollment'],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]",[],126.0,0.0648689,"RESULTS


Gain- versus loss-framing led to more positive affect toward the flyer, which predicted intentions and enrollment.","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Mikels', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, Illinois.'}, {'ForeName': 'Nathaniel A', 'Initials': 'NA', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, DePaul University, Chicago, Illinois.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Educational Psychology and Beckman Institute, University of Illinois - Urbana-Champaign.'}, {'ForeName': 'Elizabeth A L', 'Initials': 'EAL', 'LastName': 'Stine-Morrow', 'Affiliation': 'Department of Educational Psychology and Beckman Institute, University of Illinois - Urbana-Champaign.'}]",The Gerontologist,['10.1093/geront/gnaa128']
2439,32915236,Effect of Peer Mentors in Diabetes Self-management vs Usual Care on Outcomes in US Veterans With Type 2 Diabetes: A Randomized Clinical Trial.,"Importance


Diabetes is a substantial public health issue. Peer mentoring is a low-cost intervention for improving glycemic control in patients with diabetes. However, long-term effects of peer mentoring and creation of sustainable models are not well studied.
Objective


Assess the effects of a peer support intervention for improving glycemic control in patients with diabetes and evaluate a model in which former mentees serve as mentors.
Design, Setting, and Participants


A randomized clinical trial was conducted from September 27, 2012, to March 21, 2018, at the Corporal Michael J. Crescenz Medical Center. US veterans with type 2 diabetes aged 30 to 75 years with hemoglobin A1C (HbA1c) greater than 8% received support over 6 months from peers with prior poor glycemic control but who had achieved HbA1c less than or equal to 7.5% (phase 1). Phase 1 mentees were then randomized to become a mentor or not to new randomly assigned participants in phase 2. Outcomes were assessed at 6 and 12 months. Data were analyzed from October 5, 2016, to September 4, 2018.
Interventions


Mentors who received an initial training session and monthly reinforcement training were assigned 1 mentee and given $20 for each month they contacted their mentee at least weekly.
Main Outcomes and Measures


Primary outcome was HbA1c change at 6 months. Secondary outcomes included HbA1c change at 12 months and change in low-density lipoprotein, blood pressure, diabetes quality of life, and depression symptoms at 6 and 12 months.
Results


The study enrolled 365 participants into phase 1 and 122 participants into phase 2. Most participants were Black (341 [66%]) and male (454 [96%]), with a mean (SD) age of 60 (7.5) years. Mean phase 1 HbA1c change at 6 months for usual care was -0.20% (95% CI, -0.46% to 0.06%) vs -0.52% (95% CI, -0.76% to -0.29%) for mentees (P = .06). Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16). There were no differences in secondary outcomes or HbA1c levels at 12 months. There was no benefit to past mentees who became mentors.
Conclusions and Relevance


In this randomized clinical trial, a peer mentor intervention did not improve 6-month HbA1c levels and did not have sustained benefits.
Trial Registration


ClinicalTrials.gov Identifier: NCT01651117.",2020,"Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16).","['US Veterans With Type 2 Diabetes', 'Diabetes', '365 participants into phase 1 and 122 participants into phase 2', 'Most participants were Black (341 [66%]) and male (454 [96%]), with a mean (SD) age of 60 (7.5) years', 'September 27, 2012, to March 21, 2018, at the Corporal Michael J. Crescenz Medical Center', 'patients with diabetes', 'US veterans with type 2 diabetes aged 30 to 75 years with hemoglobin A1C (HbA1c) greater than 8% received support over 6 months from peers with prior poor glycemic control but who had achieved HbA1c less than or equal to 7.5% (phase 1', 'patients with diabetes and evaluate a model in which former mentees serve as mentors']","['Self-management vs Usual Care', 'Peer Mentors', 'Peer mentoring', 'peer support intervention', 'initial training session and monthly reinforcement training']","['secondary outcomes or HbA1c levels', 'HbA1c change at 6 months', '6-month HbA1c levels', 'HbA1c change at 12 months and change in low-density lipoprotein, blood pressure, diabetes quality of life, and depression symptoms']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205136', 'cui_str': 'Over'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",365.0,0.150273,"Mean phase 2 HbA1c change at 6 months for usual care was -0.46% (95% CI, -1.02% to 0.10%) vs 0.08% (95% CI, -0.42% to 0.57%) for mentees (P = .16).","[{'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Long', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, VA Center for Health Equity Research and Promotion, Philadelphia, Pennsylvania.'}, {'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Ganetsky', 'Affiliation': 'Division of Addiction Medicine and Urban Health Institute, Cooper University Hospital, Camden, New Jersey.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Canamucio', 'Affiliation': 'Veterans Integrated Service Network 4, Center for Evaluation of PACT, Philadelphia, Pennsylvania.'}, {'ForeName': 'Tanisha N', 'Initials': 'TN', 'LastName': 'Dicks', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, VA Center for Health Equity Research and Promotion, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Marcus', 'Affiliation': 'School of Social Policy and Practice, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16369']
2440,32915276,Comparison of two extended depth of focus intraocular lenses with a monofocal lens: a multi-centre randomised trial.,"PURPOSE


The AT LARA 829MP is a next-generation extended depth of focus (EDOF) intraocular lens (IOL) providing continuous vision over a range of distances. The aim of this prospective multi-centre randomised trial was to compare two EDOF IOLs and one monofocal IOL.
METHODS


Cataract patients between 50 and 80 years were randomised for bilateral implantation with either the AT LARA 829MP (EDOF), the TECNIS Symfony (EDOF) or the CT ASPHINA 409MP (monofocal). Follow-up was at 1 to 2 weeks, 1 month and 4 to 6 months.
RESULTS


A total of 211 patients were randomised and included in the final analysis. Monocular depth of focus was significantly better for AT LARA 829MP eyes compared with that for TECNIS Symfony at all thresholds (p = 0.024, 0.001 and 0.006, for 0.1, 0.2 and 0.3 logMAR respectively) with no significant difference for binocular depth of focus. LARA eyes had significantly better monocular depth of focus at all levels compared with ASPHINA eyes (all p < 0.0001), while there was no significant difference between Symfony and ASPHINA eyes at 0.1 logMAR and 0.2 logMAR. Both EDOF IOLs were significantly better than the monofocal ASPHINA at all levels for binocular depth of focus (LARA: all p < 0.0001; Symfony: all p = 0.002). Distance visual acuity was similar for all IOLs at 6 months; intermediate and near visual acuity were significantly better for the EDOF IOLs than for the monofocal (p < 0.0001). Refraction improved in all groups relative to baseline. Contrast sensitivity was higher with the CT ASPHINA 409MP but both EDOF lenses had a better spectacle independence rate. At 6 months, all IOLs were well centred with no cases of tilt. No general safety issues were raised for any of the groups.
CONCLUSION


The two EDOF intraocular lenses investigated provided good visual outcomes with comparable visual acuity at all distances. The AT LARA 829MP provided the widest monocular depth of focus at 0.1 and 0.2 logMAR, with a clear superiority compared with the monofocal IOL. TECNIS Symfony was superior to the monofocal control at 0.3 logMAR. Spectacle independence and patient satisfaction were comparable.
TRIAL REGISTRATION


Trial registered on https://clinicaltrials.gov/ under the identification NCT03172351 (date of registration 1 June May 2017).",2020,Distance visual acuity was similar for all IOLs at 6 months; intermediate and near visual acuity were significantly better for the EDOF IOLs than for the monofocal (p < 0.0001).,"['Cataract patients between 50 and 80\xa0years', 'A total of 211 patients']","['bilateral implantation with either the AT LARA 829MP (EDOF), the TECNIS Symfony (EDOF) or the CT ASPHINA 409MP (monofocal', 'intraocular lenses with a monofocal lens']","['Spectacle independence and patient satisfaction', 'near visual acuity', 'monocular depth', 'Refraction', 'Distance visual acuity', 'spectacle independence rate', 'Contrast sensitivity']","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}]",211.0,0.135817,Distance visual acuity was similar for all IOLs at 6 months; intermediate and near visual acuity were significantly better for the EDOF IOLs than for the monofocal (p < 0.0001).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Reinhard', 'Affiliation': 'Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstrasse 5, 79106, Freiburg, Germany. thomas.reinhard@uniklinik-freiburg.de.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Maier', 'Affiliation': 'Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstrasse 5, 79106, Freiburg, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Böhringer', 'Affiliation': 'Klinik für Augenheilkunde, Universitätsklinikum Freiburg, Killianstrasse 5, 79106, Freiburg, Germany.'}, {'ForeName': 'Eckart', 'Initials': 'E', 'LastName': 'Bertelmann', 'Affiliation': 'Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Brockmann', 'Affiliation': 'Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Kiraly', 'Affiliation': 'Augenlaserzentrum, Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Salom', 'Affiliation': 'Hospital de Manises, Valencia, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Piovella', 'Affiliation': 'Centro Microchirurgia Ambulatoriale, Monza, Italy.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Colonval', 'Affiliation': 'Centre Hospitalier Jolimont Lobbes, Binche, Belgium.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Mendicute', 'Affiliation': 'Hospital Universitario, Donostia, Spain.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04868-5']
2441,32915300,Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial.,"PURPOSE


The newly introduced erector spinae plane block (ESPB) has given anesthesiologists an alternative regional anesthetic technique for thoracic analgesia. Although ESPB and retrolaminar block (RLB) have similar puncture sites, no clinical study comparing ESPB and RLB has been reported. The aim of this study was to compare ESPB and RLB in terms of analgesic efficacy in the context of multimodal analgesia following breast surgery.
METHODS


Fifty female patients undergoing breast surgery under general anesthesia were randomly allocated to receive either ultrasound-guided ESPB or RLB with 20 mL of 0.375% levobupivacaine for postoperative analgesia. The primary outcome was analgesic efficacy in terms of time to first postoperative rescue analgesic after the block procedure. The secondary outcomes were consumption of remifentanil during anesthesia, pain intensity at rest for 24 h postoperatively, and occurrence of postoperative nausea and vomiting (PONV).
RESULTS


After excluding five patients, 45 patients (22 and 23 patients in the ESPB and RLB group, respectively) were analyzed. Median time until the first postoperative rescue analgesic after the block procedure in the ESPB group was not significantly longer than that in the RLB group (8.6 [range 2.7-24] vs. 4.8 [3.0-24] h; P = 0.83). There was no significant difference in the consumption of remifentanil during anesthesia, pain intensity at rest for 24 h postoperatively, and occurrence of PONV between the two groups.
CONCLUSION


ESPB is equivalent, and not superior, to RLB for postoperative analgesia after breast surgery when 20 mL of 0.375% levobupivacaine is injected at the fourth thoracic vertebra.",2020,"There was no significant difference in the consumption of remifentanil during anesthesia, pain intensity at rest for 24 h postoperatively, and occurrence of PONV between the two groups.
","['postoperative analgesia after breast surgery', 'Fifty female patients undergoing breast surgery under general anesthesia']","['ultrasound-guided ESPB or RLB with 20\xa0mL of 0.375% levobupivacaine', 'ESPB and retrolaminar block (RLB', 'RLB', 'levobupivacaine', 'Erector spinae plane block versus retrolaminar block']","['Median time until the first postoperative rescue analgesic', 'consumption of remifentanil during anesthesia, pain intensity at rest for 24\xa0h postoperatively, and occurrence of PONV', 'consumption of remifentanil during anesthesia, pain intensity at rest for 24\xa0h postoperatively, and occurrence of postoperative nausea and vomiting (PONV', 'analgesic efficacy in terms of time to first postoperative rescue analgesic']","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",50.0,0.118889,"There was no significant difference in the consumption of remifentanil during anesthesia, pain intensity at rest for 24 h postoperatively, and occurrence of PONV between the two groups.
","[{'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Sotome', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sawada', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan. atusihon7@gmail.com.'}, {'ForeName': 'Asaka', 'Initials': 'A', 'LastName': 'Wada', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shima', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Kutomi', 'Affiliation': 'Department of Surgery, Surgical Oncology and Science, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Yamakage', 'Affiliation': 'Department of Anesthesiology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.'}]",Journal of anesthesia,['10.1007/s00540-020-02855-y']
2442,32915325,"Percutaneous trans-ulnar versus trans-radial arterial approach for coronary angiography and angioplasty, a preliminary experience at an Egyptian cardiology center.","BACKGROUND


Trans-ulnar approach was proposed primarily for elective procedures in patients not suitable for trans-radial approach that was introduced two decades ago. The trans-ulnar approach is as safe and effective as the trans-radial approach for coronary angiography and intervention.
AIM


This study's aim was to assess the feasibility and safety of the trans-ulnar approach in coronary procedures as a preliminary experience for operators experienced in trans-radial approach with no/minimal trans-ulnar approach experience at an Egyptian center.
RESULTS


Vascular access in 120 patients was selected randomly for coronary angiography and angioplasty-80 through radial and 40 through ulnar approach. Patients were examined for local complications and Doppler evaluation to both radial and ulnar arteries a day after the procedure was done. Ulnar approach success was 82.5% versus 93.7% in the radial group; failure of ulnar artery puncture was the only cause of crossover in the ulnar group, while occurrence of persistent spasm was the leading cause of crossover in the radial group followed by radial artery tortuosity. The procedure time of coronary angiography and percutaneous coronary intervention of the ulnar group was significantly higher than that of the radial group (P value = 0.011 and 0.034, respectively). The mean caliber of the right ulnar artery was 2.45 ± 0.38, slightly larger than that of the radial artery 2.33 ± 0.38 at the level of the wrist, but this difference was statistically non-significant.
CONCLUSION


Our study demonstrated that ulnar access with experienced radial operators and in our patients is a safe and practical approach for coronary angiography or angioplasty, without any major complications. Bearing in mind its high success rate, it can be used when a radial artery is not useful for the catheterization or as a default approach on the expense of slightly longer procedural time.",2020,"The procedure time of coronary angiography and percutaneous coronary intervention of the ulnar group was significantly higher than that of the radial group (P value = 0.011 and 0.034, respectively).","['120 patients was selected randomly for coronary angiography and angioplasty-80 through radial and 40 through ulnar approach', 'coronary procedures as a preliminary experience for operators experienced in trans-radial approach with no/minimal trans-ulnar approach experience at an Egyptian center']","['Percutaneous trans-ulnar versus trans-radial arterial approach for coronary angiography and angioplasty', 'trans-ulnar approach']","['mean caliber of the right ulnar artery', 'local complications and Doppler evaluation', 'Ulnar approach success', 'feasibility and safety', 'procedure time of coronary angiography and percutaneous coronary intervention', 'failure of ulnar artery puncture']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0226428', 'cui_str': 'Structure of right ulnar artery'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}]",120.0,0.118131,"The procedure time of coronary angiography and percutaneous coronary intervention of the ulnar group was significantly higher than that of the radial group (P value = 0.011 and 0.034, respectively).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shafiq', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt. shafiqsssd@gmail.com.'}, {'ForeName': 'Hesham Boushra', 'Initials': 'HB', 'LastName': 'Mahmoud', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Beni-Suef University, Beni Suef, Egypt.'}, {'ForeName': 'Malak Lamie', 'Initials': 'ML', 'LastName': 'Fanous', 'Affiliation': 'Cardiology Department, Sohag Heart and GIT Specialized Center, Sohag, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00089-7']
2443,32915514,Sleep-wake patterns in newborns are associated with infant rapid weight gain and incident adiposity in toddlerhood.,"BACKGROUND


Rapid weight gain (RWG) by 6 months of life is a significant risk factor of childhood overweight (OW)/obesity. Infant sleep patterns are associated with incident OW in childhood, but few have examined its relationship with RWG.
OBJECTIVE


Examine associations between newborn sleep-wake patterns and incident RWG at 6 months of life and OW at 36 months.
METHODS


Low-income Mexican/Mexican-American women with OW/obesity and their infants (n = 126) enrolled in a 1-year randomized controlled trial designed to prevent incident, infant RWG and toddlerhood OW/obesity. Sleep pattern metrics at 1 month were extracted from the Brief Infant Sleep Questionnaire-Revised. Outcome measures included RWG (>0.67 positive change in weight-for-age Z-score) from birth to 6 months and incident OW (body mass index percentile ≥85) at 36 months.
RESULTS


By 6 months, 35.7% (n = 45) of infants experienced RWG, and by 36 months 42.3% (n = 41) of toddlers were OW. Napping ≥5x/day at 1-month was significantly associated with decreased odds for RWG compared to napping <5x (OR = 0.11, 95%CI:0.02, 0.63). Each 1-hour increase in nocturnal vs diurnal sleep was associated with greater odds of incident OW at 36 mos (OR = 1.51, 95%CI:1.13, 2.03).
CONCLUSIONS


Early-life sleep patterns related to infant nap frequency and nocturnal vs diurnal sleep distribution were associated with obesity outcomes and may be important intervention targets to prevent lasting consequences on infant growth.",2020,"Napping ≥5x/day at 1-month was significantly associated with decreased odds for RWG compared to napping <5x (OR = 0.11, 95%CI:0.02, 0.63).",['Low-income Mexican/Mexican-American women with OW/obesity and their infants (n = 126'],[],"['nocturnal vs diurnal sleep', 'RWG', 'Sleep pattern metrics', 'newborn sleep-wake patterns and incident RWG']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0470256', 'cui_str': '126'}]",[],"[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",126.0,0.0866917,"Napping ≥5x/day at 1-month was significantly associated with decreased odds for RWG compared to napping <5x (OR = 0.11, 95%CI:0.02, 0.63).","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Petrov', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona, USA.'}, {'ForeName': 'Corrie M', 'Initials': 'CM', 'LastName': 'Whisner', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, Arizona, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCormick', 'Affiliation': 'Division of General Academic Pediatrics, University of Texas Medical Branch at Galveston, Galveston, Texas, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Todd', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Reyna', 'Affiliation': 'Reina Enterprises, New York, New York, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Reifsnider', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona, USA.'}]",Pediatric obesity,['10.1111/ijpo.12726']
2444,32915523,Early benefits of empagliflozin in patients with or without heart failure: findings from EMPA-REG OUTCOME.,"AIMS


The EMPA-REG OUTCOME trial demonstrated reductions in cardiovascular (CV) death and heart failure (HF) outcomes with empagliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes and established CV disease over a study period of 3 years. We aimed to investigate the early benefit-risk profile of empagliflozin in patients enrolled in the EMPA-REG OUTCOME trial according to HF status at baseline.
METHODS AND RESULTS


The effects of treatments on glycated haemoglobin, systolic blood pressure and body weight, and on the HF endpoints of hospitalization for HF (HHF), HHF or CV death, and HHF or all-cause mortality were evaluated at 12 weeks, 6 months, and 1 year after randomization. Occurrence of adverse events (AEs) during these time points was also evaluated. Compared with placebo, empagliflozin lowered glycated haemoglobin, systolic blood pressure, and body weight and rates of all the HF endpoints, as early as at 12 weeks, regardless of HF status at baseline. Favourable clinical and metabolic effects were maintained over time. AEs were generally higher in those with HF than without HF; however, compared with placebo, empagliflozin did not increase risk of developing AEs over the first year of treatment.
CONCLUSIONS


In the EMPA-REG OUTCOME trial, the use of empagliflozin led to early and beneficial effects on clinical, metabolic, and HF outcomes in patients with type 2 diabetes with or without HF at baseline, which were already apparent within 12 weeks from initiation of treatment. Over the first year of treatment, no safety concern was detected with the use of empagliflozin.",2020,"Compared with placebo, empagliflozin lowered glycated haemoglobin, systolic blood pressure, and body weight and rates of all the HF endpoints, as early as at 12 weeks, regardless of HF status at baseline.","['patients with type 2 diabetes', 'patients with or without heart failure', 'patients enrolled in the EMPA-REG OUTCOME trial according to HF status at baseline', 'patients with type 2 diabetes and established CV disease over a study period of 3\xa0years']","['empagliflozin', 'placebo, empagliflozin']","['Occurrence of adverse events (AEs', 'glycated haemoglobin, systolic blood pressure and body weight, and on the HF endpoints of hospitalization for HF (HHF), HHF or CV death, and HHF or all-cause mortality', 'cardiovascular (CV) death and heart failure (HF) outcomes', 'risk of developing AEs', 'clinical, metabolic, and HF outcomes', 'Favourable clinical and metabolic effects', 'glycated haemoglobin, systolic blood pressure, and body weight and rates of all the HF endpoints']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.188311,"Compared with placebo, empagliflozin lowered glycated haemoglobin, systolic blood pressure, and body weight and rates of all the HF endpoints, as early as at 12 weeks, regardless of HF status at baseline.","[{'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Pellicori', 'Affiliation': 'Robertson Centre for Biostatistics, Glasgow Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Zeller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}]",ESC heart failure,['10.1002/ehf2.12891']
2445,32906606,Effects of Topical Prostaglandin Analog on Macular Thickness Following Cataract Surgery with Postoperative Topical Bromfenac Treatment.,"PURPOSE


To evaluate changes in macular thickness in patients continuing prostaglandin analog (PGA) treatment during the perioperative period involving bromfenac treatment.
METHODS


Patients with glaucoma who were using a topical PGA were randomly assigned to two groups in this randomized controlled trial: PGA continuing study group and PGA discontinued glaucoma control group. Patients without ocular diseases other than cataract were enrolled into the non-glaucomatous group. After the cataract surgery, the patients used bromfenac twice per day for 4 weeks. Optical coherence tomography was performed in all patients preoperatively and at 1 month postoperatively. Changes in macular thickness were compared among the three groups.
RESULTS


There were 32 eyes in the study group, 33 eyes in the glaucoma control group, and 58 eyes in the non-glaucomatous group. We found statistically significant postoperative changes in central macular thickness in all groups (4.30 ± 8.01 μm in the PGA continuing group, 9.20 ± 13.88 μm in the PGA discontinued group, and 7.06 ± 7.02 μm in the non-glaucomatous group, all  p  < 0.008), but no significant difference among the three groups ( p  = 0.161). Cystoid macular edema occurred in only one patient in the non-glaucomatous group ( p  = 0.568).
CONCLUSIONS


Continuous use of PGAs during the perioperative period was not significantly associated with increased macular thickness after uncomplicated cataract surgery. In the absence of other risk factors (e.g., capsular rupture, uveitis, or diabetic retinopathy), discontinuing PGAs for the prevention of macular edema after cataract surgery with postoperative bromfenac treatment is unnecessary in patients with glaucoma.",2020,"Cystoid macular edema occurred in only one patient in the non-glaucomatous group ( p  = 0.568).
","['32 eyes in the study group, 33 eyes in the glaucoma control group, and 58 eyes in the non-glaucomatous group', 'Patients without ocular diseases other than cataract were enrolled into the non-glaucomatous group', 'patients with glaucoma', 'Macular Thickness Following Cataract Surgery with Postoperative Topical Bromfenac Treatment', 'patients continuing prostaglandin analog (PGA) treatment during the perioperative period involving bromfenac treatment', 'Patients with glaucoma who were using a topical PGA']","['PGA discontinued glaucoma control group', 'Topical Prostaglandin Analog', 'Optical coherence tomography']","['macular thickness', 'Cystoid macular edema', 'central macular thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0054094', 'cui_str': 'bromfenac'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0033568', 'cui_str': 'Prostaglandin analog'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",,0.0216944,"Cystoid macular edema occurred in only one patient in the non-glaucomatous group ( p  = 0.568).
","[{'ForeName': 'Kee Sup', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Kyoung Nam', 'Initials': 'KN', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Kyeung Min', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Han Min', 'Initials': 'HM', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Sung Bok', 'Initials': 'SB', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}, {'ForeName': 'Nam Ho', 'Initials': 'NH', 'LastName': 'Lee', 'Affiliation': 'Mindeulle Eye Clinic, 9 Samsannam-ro, Boeun 28950, Korea.'}, {'ForeName': 'Chang-Sik', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Chungnam National University College of Medicine, Daejeon 35015, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9092883']
2446,32906673,Applicability and Eligibility of the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) for Patients who Underwent Revascularization with Percutaneous Coronary Intervention.,"In the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial, an early invasive strategy did not decrease mortality compared to a conservative strategy for stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia, and the role of revascularization would be revised. However, the applicability and potential influence of this trial in daily practice remains unclear. Our objective was to assess the eligibility and representativeness of the ISCHEMIA trial on the patients with percutaneous coronary intervention (PCI). From a multicenter registry, we extracted a consecutive 13,223 SIHD patients with PCI (baseline cohort). We applied ISCHEMIA eligibility criteria and compared the baseline characteristics between the eligible patients and the actual study participants (randomized controlled trial (RCT) patients). In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry. In the baseline cohort, 77.3% of SIHD patients with moderate-to-severe ischemia were eligible for the ISCHEMIA. They were comparable with RCT patients for baseline characteristics and outcomes unlike the non-eligible patients. In conclusion, the trial results seem applicable for the majority of PCI patients with moderate-to-severe ischemia except for the non-eligible patients.",2020,"In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry.","['patients with percutaneous coronary intervention (PCI', 'stable ischemic heart disease (SIHD) patients with moderate-to-severe ischemia', '13,223 SIHD patients with PCI (baseline cohort', '3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry', 'SIHD patients with moderate-to-severe ischemia', 'Patients who Underwent Revascularization with Percutaneous Coronary Intervention']","['RCT', 'Medical and Invasive Approaches (ISCHEMIA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",[],3463.0,0.0871434,"In 3463 patients with follow-up information (follow-up cohort), the 2 year composite of major adverse cardiac events was evaluated between the eligible patients and RCT patients, as well as eligible and non-eligible patients in the registry.","[{'ForeName': 'Nozomi', 'Initials': 'N', 'LastName': 'Niimi', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Sawano', 'Affiliation': 'Department of Cardiology, Tokyo Dental College Ichikawa General Hospital, Chiba Prefecture 272-8513, Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Ikemura', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Nagai', 'Affiliation': 'Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine, Sapporo 060-8638, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Cardiology, Saitama Medical University, International Medical Center, Saitama Prefecture 350-1298, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Shoji', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Ikuko', 'Initials': 'I', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Numasawa', 'Affiliation': 'Department of Cardiology, Japanese Red Cross Ashikaga Hospital, Tochigi Prefecture 326-0843, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Cardiology, National Hospital Organization Saitama Hospital, Saitama Prefecture 351-0102, Japan.'}, {'ForeName': 'Shigetaka', 'Initials': 'S', 'LastName': 'Noma', 'Affiliation': 'Department of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi Prefecture 321-0974, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fukuda', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo 160-8582, Japan.'}]",Journal of clinical medicine,['10.3390/jcm9092889']
2447,32906825,Velocity Loss Thresholds Reliably Control Kinetic and Kinematic Outputs during Free Weight Resistance Training.,"Exercise velocity and relative velocity loss thresholds (VLTs) are commonly used in velocity-based resistance training. This study aims to quantify the between-day reliability of 10%, 20%, and 30% VLTs on kinetic and kinematic outputs, changes in external load, and repetition characteristics in well-trained athletes. Using a repeated, counter-balanced crossover design, twelve semi-professional athletes completed five sets of the back squat with an external load corresponding to a mean concentric velocity of ~0.70 m·s -1  and a VLT applied. The testing sessions were repeated after four weeks of unstructured training to assess the long-term reliability of each VLT. A coefficient of variation (CV) <10% was used to classify outputs as reliable. Kinetic and kinematic outputs and external load were largely reliable, with only peak power during sets 2-5 within the 10% VLT condition demonstrating a CV >10% (CV: 11.14-14.92%). Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%). These findings demonstrate that by utilizing VLTs, kinetic and kinematic outputs can be prescribed and replicated across training mesocycles. Thus, for practitioners wishing to reliably control the kinetic and kinematic stimulus that is being applied to their athletes, it is advised that a velocity-based approach is used.",2020,"Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%).",['well-trained athletes'],[],"['Kinetic and kinematic outputs and external load', 'kinetic and kinematic outputs, changes in external load, and repetition characteristics', 'Exercise velocity and relative velocity loss thresholds (VLTs']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.0261417,"Alternatively, the repetitions completed within each set showed large variation (CV: 18.92-67.49%).","[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Pearson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Sports Sciences and Physical Conditioning, Faculty of Education, Universidad Católica de la Santísima Concepción, Concepción 2850, Chile.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morrison', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ramirez-Lopez', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds LS6 3GZ, West Yorkshire, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dalton-Barron', 'Affiliation': 'Institute for Sport, Physical Activity and Leisure, Leeds Beckett University, Leeds LS6 3GZ, West Yorkshire, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Weakley', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane 4014, Queensland, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186509']
2448,32906842,Development and Evaluation of an Antiviral Agent Medication Adherence Education Program for Patients with Chronic Hepatitis C.,"This study aimed to develop and evaluate a goal attainment theory-based antiviral agent medication adherence education program (AMAEP) for patients with chronic hepatitis C. A nonequivalent control group pretest-posttest design was used. Data were collected from December 2019 to March 2020 from a control group of 35 outpatients and an experimental group of 28 outpatients older than 20 years old who had been diagnosed with chronic hepatitis C. The data analysis included an independent  t -test, a χ 2 -test or Fisher's exact test, a Kolmogorov-Smirnov test, an analysis of covariance, and a Mann-Whitney U test. The results showed the effectiveness of the education program for patients with chronic hepatitis C. There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001). Therefore, we hope that the education program developed in this study will be utilized as an intervention for patients with chronic hepatitis C and be further developed for other patients with viral hepatitis.",2020,"There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001).","['Data were collected from December 2019 to March 2020 from a control group of 35 outpatients and an experimental group of 28 outpatients older than 20 years old who had been diagnosed with chronic hepatitis C', 'Patients with Chronic Hepatitis C', 'patients with chronic hepatitis C and be further developed for other patients with viral hepatitis', 'patients with chronic hepatitis C']","['Antiviral Agent Medication Adherence Education Program', 'goal attainment theory-based antiviral agent medication adherence education program (AMAEP']","['medication adherence rate', 'medication misuse behavior', 'medication self-efficacy', 'knowledge of chronic hepatitis C']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis'}]","[{'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036600', 'cui_str': 'Self-medication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}]",28.0,0.028512,"There were significant differences between the control group and experimental group in patients' knowledge of chronic hepatitis C (Z = -5.91,  p  < 0.001), medication self-efficacy (Z = -5.02,  p  < 0.001), medication adherence rate ( t  = -3.88,  p  < 0.001), medication misuse behavior (Z = -5.00,  p  < 0.001), and patients' satisfaction with their interaction with healthcare practitioners (Z = -6.61,  p  < 0.001).","[{'ForeName': 'Hoo Jeung', 'Initials': 'HJ', 'LastName': 'Cho', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan 48513, Korea.'}, {'ForeName': 'Euna', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Pukyong National University, Busan 48513, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186518']
2449,32907282,[The effect of booster dose vaccination 21- to 32-years after primary vaccination with hepatitis B vaccine in the population born from 1986 to 1996 in Zhengding County of Hebei Province].,"Objective:  Aanalysis the effect of booster one dose of hepatitis B vaccine after 21-32 years of primary immunization in Zhengding Country of Hebei Province.  Methods:  A total of 322 participants who were born between 1986 and 1996, received a full course of primary vaccination with plasma-derived hepatitis B vaccine (HepB), had no experience with booster vaccination, were HBsAg, anti-HBcnegative, had anti-HBs<10 mIU/ml, completed the booster and had laboratory results were enrolled between August 2017 to February 2018. A simple random method was uesd to randomly assigned 322 subjects to two groups, receiving a booster dose of HepB derived from either Saccharomyces cerevisiae ［HepB (SC), (151 cases)］ or Chinese hamster ovary-derived HepB ［HepB (CHO), (171 cases)］, the dose was 20 μg. Blood samples were collected 30 days after boosting and quantitatively tested for the geometric mean concentration (GMC) of anti-HBs to assess immunological effect. The related influencing factors of GMC and seroconversion rates of anti-HBs were analyzed by multiple linear regression and multivariate logistic regression models.  Results:  The 266 subjects (82.61%) had anti-HBs≥ 10 mIU/ml, and GMC was (131.63±12.94) mIU/ml.The seroconversion rates of anti-HBs in the anti-HBs<2.5 mIU/ml group and 2.5-10 mIU/ml group were 74.54% (161 cases) and 99.06% (105 cases), respectively ( P <0.001).The seroconversion rates of anti-HBs after one dose of HepB (CHO) was higher than that of one dose of HepB (SC), the seroconversion rates were 87.13% (149 cases) and 77.48% (117 cases), respectively ( P =0.023). Participants boostered with HepB (CHO) was the factor influencing the effect of strengthening immunization compared with boostered with HepB (SC), and  OR  (95% CI ) was 1.91 (1.02-3.56) ( P =0.042).Compared with anti-HBs<2.5 mIU/ml, prebooster anti-HBs was between 2.5 mIU/ml and 10 mIU/ml was the related factor of seroconversion rates of anti-HBs after booster immunization, and  OR  (95% CI ) was 36.15 (4.91-266.02) ( P <0.001).  Conclusion:  Participants boostered withone dose of HepB had a good immune response. Pre-booster anti-HBs concentration and a variety of vaccine were related factors of immune response.",2020,"The seroconversion rates of anti-HBs in the anti-HBs<2.5 mIU/ml group and 2.5-10 mIU/ml group were 74.54% (161 cases) and 99.06% (105 cases), respectively ( P <0.001).The seroconversion rates of anti-HBs after one dose of HepB (CHO) was higher than that of one dose of HepB (SC), the seroconversion rates were 87.13% (149 cases) and 77.48% (117 cases), respectively ( P =0.023).","['after 21-32 years of primary immunization in Zhengding Country of Hebei Province', 'population born from 1986 to 1996 in Zhengding County of Hebei Province', '322 participants who were born between 1986 and 1996, received a full course of primary vaccination with plasma-derived hepatitis B vaccine (HepB), had no experience with booster vaccination, were HBsAg, anti-HBcnegative, had anti-HBs<10 mIU/ml, completed the booster and had laboratory results were enrolled between August 2017 to February 2018', '266 subjects (82.61%) had anti-HBs≥ 10 mIU/ml, and GMC was (131.63±12.94) mIU/ml']","['hepatitis B vaccine', 'HepB', 'booster dose of HepB derived from either Saccharomyces cerevisiae ［HepB (SC), (151 cases)］ or Chinese hamster ovary-derived HepB ［HepB (CHO', 'booster dose vaccination 21- to 32-years after primary vaccination with hepatitis B vaccine']","['seroconversion rates', 'GMC and seroconversion rates of anti-HBs', 'seroconversion rates of anti-HBs']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1328526', 'cui_str': 'Primary immunization'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0061073', 'cui_str': 'gamma-hydroxy-gamma-ethyl-gamma-phenylbutyramide'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0018555', 'cui_str': 'Chinese Hamster'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0201478', 'cui_str': 'Hepatitis B surface antibody measurement'}]",322.0,0.0969828,"The seroconversion rates of anti-HBs in the anti-HBs<2.5 mIU/ml group and 2.5-10 mIU/ml group were 74.54% (161 cases) and 99.06% (105 cases), respectively ( P <0.001).The seroconversion rates of anti-HBs after one dose of HepB (CHO) was higher than that of one dose of HepB (SC), the seroconversion rates were 87.13% (149 cases) and 77.48% (117 cases), respectively ( P =0.023).","[{'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Zhang', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'Z W', 'Initials': 'ZW', 'LastName': 'Wu', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'Y H', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Li', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Zhou', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Han', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Hao', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chu', 'Affiliation': 'Zhengding County Center for Disease Control and Prevention，Shijiazhuang 050800, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Ma', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Zhao', 'Affiliation': 'Hebei Province Center for Disease Control and Prevention, Shijiazhuang 050021, China.'}]",Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine],['10.3760/cma.j.cn112150-20200509-00710']
2450,32907283,[ A phase  Ⅲ  clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants ].,"Objective:  The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants.  Methods:  From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348).  Results:  The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine ( P <0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) ( P <0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) ( P <0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) ( P <0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) ( P >0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 ( P >0.05); the group C test vaccine (43.53) was higher than the control group (27.28) ( P <0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) ( P <0.001).  Conclusion:  ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.",2020,"The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) ( P >0.05).","['3 month old infants ', '3 months (90-119 days) infants', 'subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio']","['control vaccine', 'meningococcal conjugate vaccine', 'vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine', 'ACYW135 group meningococcal conjugate vaccine']","['positive conversion rate of anti-bacterial serum antibodies', 'incidence of systemic adverse reactions', 'local adverse reaction rate', 'graded adverse reaction test vaccine', 'safety and immunogenicity', 'overall adverse reaction rate']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0620904,"The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) ( P >0.05).","[{'ForeName': 'Z Q', 'Initials': 'ZQ', 'LastName': 'Xie', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'D Y', 'Initials': 'DY', 'LastName': 'Zhao', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Huang', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Gou', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou 450001, China.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Huang', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'Y X', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Xu', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'CanSino Biologics Inc., Tianjin 300457, China.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Xia', 'Affiliation': 'Center of Vaccine Clinical Trial, Henan Center for Disease Control and Prevention, Zhengzhou 450016, China.'}]",Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine],['10.3760/cma.j.cn112150-20200520-00758']
2451,32900662,"Comparative Safety, Bioavailability, and Pharmacokinetics of Oral Dexamethasone, 4-mg and 20-mg Tablets, in Healthy Volunteers Under Fasting and Fed Conditions: A Randomized Open-label, 3-way Crossover Study.","BACKGROUND


Glucocorticoids, particularly dexamethasone, are often used in combination with novel agents in multiple myeloma. This study compared the safety, rate, and extent of absorption of a single dose of an orally administered 20-mg dexamethasone tablet to five 4-mg tablets (total, 20 mg).
PATIENTS AND METHODS


This was a single-center, open-label, randomized, 3-way crossover comparative study. Thirty-six volunteers received at least 1 dose of either a single 20-mg dexamethasone tablet, under fasting or fed conditions, or five 4-mg dexamethasone tablets (total, 20 mg). Blood samples were collected before study drug administration and at 21 time points for up to 36 hours after drug administration.
RESULTS


Mean area under the concentration-time curve from time zero to the time of last non-zero concentration (AUC 0-t ), mean area under the concentration-time curve from time zero to infinity (extrapolated) (AUC 0-∞ ), and maximum observed concentration (C max ) were 1314.38 ng × h/mL, 1329.24 ng × h/mL, and 257.22 ng/mL, respectively for fasting test formulation (single dexamethasone 20-mg tablet), 1339.74 ng × h/mL, 1358.07 ng × h/mL, and 194.56 ng/mL, respectively, for the fed test formulation (single dexamethasone 20-mg tablet), and 1325.12 ng × h/mL, 1342.12 ng × h/mL, and 244.12 ng/mL, respectively, for the reference formulation (5 dexamethasone 4-mg tablets). The median time of observed C max  was 0.997 hours for the fasting and 2.502 hours for the fed test formulation, compared with 1.495 hours for the reference. Mean plasma elimination half-lives (t 1/2 ) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference). The point estimates and 90% confidence intervals (CIs) for AUC 0-t , AUC 0-∞ , and C max  were 99.37% (90% CI, 95.65%-103.24%), 99.24% (90% CI, 95.47%-103.16%), and 106.28% (90% CI, 97.69%-115.62%), respectively, satisfying the bioequivalence criteria of the United States Food and Drug Administration guidelines.
CONCLUSION


The 2 formulations were well-tolerated, and one 20-mg tablet or five 4-mg tablets of dexamethasone are bioequivalent under fasting conditions and thus may be prescribed interchangeably.",2020,"Mean plasma elimination half-lives (t 1/2 ) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference).","['Healthy Volunteers', 'Thirty-six volunteers']","['Oral Dexamethasone, 4-mg and 20-mg Tablets', 'dexamethasone', 'Under Fasting and Fed Conditions', 'dexamethasone tablet, under fasting or fed conditions, or five 4-mg dexamethasone tablets']","['median time of observed C max', 'Comparative Safety, Bioavailability, and Pharmacokinetics', 'Mean plasma elimination half-lives']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1245770', 'cui_str': 'Dexamethasone Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",36.0,0.0866841,"Mean plasma elimination half-lives (t 1/2 ) were 4.0 hours (test fasting), 4.03 hours (test fed), and 3.96 hours (reference).","[{'ForeName': 'Qaiser', 'Initials': 'Q', 'LastName': 'Bashir', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: QBashir@mdanderson.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Acosta', 'Affiliation': 'Acrotech BioPharma, Irvine, CA.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.06.022']
2452,32900671,"Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study.","BACKGROUND


Hypersexual disorder (HD) is a condition in which the individual experiences loss of control over engagement in sexual behaviors, leading to negative effects on various areas of life. Paraphilias often present concomitantly with HD, and although cognitive behavioral therapy (CBT) has been proven to reduce engagement in hypersexual behavior, no studies have investigated the effects of Internet-administered CBT (ICBT) on HD, with or without paraphilia(s) or paraphilic disorder(s).
AIM


To investigate the effects of Internet-administered CBT on HD, with or without paraphilia(s) or paraphilic disorder(s).
METHODS


Male participants (n = 36) evaluated positive according to the proposed diagnostic HD criteria, with or without paraphilia(s) or paraphilic disorder(s), received 12 weeks of ICBT. Measures were administered weekly over the treatment period, with an additional follow-up measurement 3 months after completion of treatment. An assessment interview was performed 2 weeks after treatment.
OUTCOMES


The primary outcome was the Hypersexual Behavior Inventory (HBI-19), and secondary outcomes were the Hypersexual Disorder: Current Assessment Scale (HD:CAS), the Sexual Compulsivity Scale (SCS), as well as a tentative composite of 6 Severity Self-rating Measures, for Paraphilic Disorders and depression (Montgomery-Åsberg Depression Rating Scale [MADRS-S]), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure [CORE-OM]), and treatment satisfaction (CSQ-8).
RESULTS


Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms. These effects remained stable 3 months after treatment.
CLINICAL IMPLICATIONS


ICBT can ameliorate HD symptoms, psychiatric distress, and paraphilic symptoms, which suggests that the ICBT for HD, with or without paraphilia(s) or paraphilic disorder(s), may constitute a valuable addition of treatment options in clinical settings.
STRENGTHS AND LIMITATIONS


This is the first study evaluating the efficacy of ICBT on a sample of men suffering from HD. In addition, a proportion of the sample reported concomitant paraphilic interests and disorders, thus mirroring an everyday clinical practice in the field of sexual medicine. No control group was assigned, and some of the outcome measures are still to be validated. The long-term effects of ICBT and its efficacy in hypersexual women are unknown.
CONCLUSIONS


This study gives support for ICBT as an effective treatment option for HD. Future evaluations of the treatment program should include women and larger samples in randomized controlled procedures and investigate the long-term effects. Hallberg J, Kaldo V, Arver S, et al. Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study. J Sex Med 2020;XX:XXX-XXX.",2020,"Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms.","['men suffering from HD', 'hypersexual women', 'Men', 'Male participants (n\xa0=\xa036) evaluated positive according to the proposed diagnostic HD criteria, with or without paraphilia(s) or paraphilic disorder(s), received 12\xa0weeks of']","['cognitive behavioral therapy (CBT', 'Internet-administered CBT', 'Internet-Administered Cognitive Behavioral Therapy', 'ICBT', 'Paraphilic']","['HD symptoms, psychiatric distress, and paraphilic symptoms', 'Hypersexual Behavior Inventory (HBI-19), and secondary outcomes were the Hypersexual Disorder', 'Current Assessment Scale (HD:CAS), the Sexual Compulsivity Scale (SCS), as well as a tentative composite of 6 Severity Self-rating Measures, for Paraphilic Disorders and depression (Montgomery-Åsberg Depression Rating Scale [MADRS-S]), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure [CORE-OM]), and treatment satisfaction (CSQ-8', 'HD symptoms and sexual compulsivity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030482', 'cui_str': 'Paraphilia'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030482', 'cui_str': 'Paraphilia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0407582,"Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hallberg', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Sweden & Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden; Department of Psychology, Faculty of Health and Life Sciences, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Piwowar', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Sweden & Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden; Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Katarina Görts', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden. Electronic address: katarina.gorts-oberg@sll.se.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.07.018']
2453,32900672,[Communicating test results in a comprehensible manner: A randomized controlled trial of word usage in doctor-patient communication].,"INTRODUCTION


Doctor-patient communication is one of the hallmarks of good medical treatment. Mutual understanding is of foremost importance, in particular when communicating non-numerical test results.
METHODS


Using a two-step approach, this study analyses the influence of wording on the correct understanding of medical test results by people without a medical background. In a first step, a qualitative analysis of physicians' letters helped to identify adjectives that are frequently used to communicate test results. In a second step, a parallel randomised study was conducted to test the comprehensibility of particularly relevant adjectives, combining the written communication of test results with a subsequent survey. 1,131 participants, representing the population of Germany with regard to age, gender, and educational level, were recruited via an online platform. The participants read a scenario involving the communication of the results of a breath test, whereby non-numerical test results were described as being either ""positive"" vs. ""negative"" (n=566) or ""abnormal"" vs. ""normal"" (n=565). Participant assignment to one of these groups took place in a randomised way. The outcomes measured included the subjective and objective understanding of test results as well as the participants' subjective comprehension of the physician communicating with them.
RESULTS


People without a medical background can understand medical test results more readily when neutral, descriptive adjectives are used rather than adjectives considered as being judgmental in everyday language. 54 % of the participants who read test results using the adjectives ""positive"" vs. ""negative"" and 65 % of the participants who read test results using the adjectives ""abnormal"" vs. ""normal"", respectively, understood the results correctly. This relative difference of 20.4 % in the number of participants with a correct understanding is statistically significant (Chi square=13.061; p=0.001). There was also a considerable difference in the subjective understanding (means of 5.04 of ""positive"" vs. ""negative"" and 5.47 for ""abnormal"" vs. ""normal"" on a 7-point Likert scale; absolute mean difference 0.42 [95 % CI: 0.20; 0.64]) as well as in the subjective comprehension of the communicating physician (means of 4.49 for ""positive"" vs. ""negative"" and 4.95 for ""abnormal"" vs. ""normal"" on a 7-point Likert scale; absolute mean difference 0.45 [95% CI: 0.23; 0.67]). A higher level of comprehension for the words ""abnormal"" vs. ""normal"" was consistent across the overall sample. It is mainly people with no school-leaving certificate and a lower educational level who benefit from the changed wording.
CONCLUSIONS


In the process of communicating non-numerical medical test results, people without a medical background understand neutral, descriptive adjectives better than adjectives that are considered judgmental in everyday usage. A corresponding change of written and oral communication can easily be implemented by medical experts in their everyday practice and particularly supports a population group that already suffers disadvantages in the medical system.",2020,This relative difference of 20.4 % in the number of participants with a correct understanding is statistically significant (Chi square=13.061; p=0.001).,"['1,131 participants, representing the population of Germany with regard to age, gender, and educational level, were recruited via an online platform', 'people without a medical background']","['positive"" vs. ""negative"" (n=566) or ""abnormal"" vs. ""normal']","[""subjective and objective understanding of test results as well as the participants' subjective comprehension of the physician communicating with them"", 'subjective comprehension of the communicating physician']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0332287', 'cui_str': 'With'}]",1131.0,0.0492124,This relative difference of 20.4 % in the number of participants with a correct understanding is statistically significant (Chi square=13.061; p=0.001).,"[{'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Auschra', 'Affiliation': 'Freie Universität Berlin, Fachbereich Wirtschaftswissenschaft, Management-Department, Berlin, Deutschland.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Möller', 'Affiliation': 'Freie Universität Berlin, Fachbereich Wirtschaftswissenschaft, Marketing-Department, Berlin, Deutschland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Berthod', 'Affiliation': 'Jacobs University Bremen, Department of Business & Economics, Bremen, Deutschland.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Mazheika', 'Affiliation': 'Wagener-Stiftung für Sozialpädiatrie, Bremen, Deutschland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Borusiak', 'Affiliation': 'Wagener-Stiftung für Sozialpädiatrie, Bremen, Deutschland; Universität Witten/Herdecke, Fakultät für Gesundheit, Department für Humanmedizin, Witten, Deutschland. Electronic address: peter.borusiak@gesundheitnord.de.'}]","Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen",['10.1016/j.zefq.2020.07.007']
2454,32900785,"Effects of DPP-4 Inhibitor Linagliptin Versus Sulfonylurea Glimepiride as Add-on to Metformin on Renal Physiology in Overweight Patients With Type 2 Diabetes (RENALIS): A Randomized, Double-Blind Trial.","OBJECTIVE


To compare effects of the dipeptidyl peptidase 4 (DPP-4) inhibitor linagliptin with those of a sulfonylurea on renal physiology in metformin-treated patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS


In this double-blind randomized trial, 46 overweight T2DM patients without renal impairment received once-daily linagliptin (5 mg) or glimepiride (1 mg) for 8 weeks. Fasting glomerular filtration rate (GFR) and effective renal plasma flow (ERPF) were determined by inulin and para-aminohippuric acid clearances. Fractional excretions, urinary damage markers, and circulating DPP-4 substrates (among others, glucagon-like peptide 1 and stromal cell-derived factor-1α (SDF-1α)) were measured.
RESULTS


HbA 1c  reductions were similar with linagliptin (-0.45 ± 0.09%) and glimepiride (-0.65 ± 0.10%) after 8 weeks ( P  = 0.101). Linagliptin versus glimepiride did not affect GFR, ERPF, estimated intrarenal hemodynamics or damage-makers. Only linagliptin increased fractional excretion (FE) of sodium (FE Na ) and potassium FE K , without affecting lithium FE Li . Linagliptin-induced change in FE Na  correlated with SDF-1α ( R  = 0.660) but not with other DPP-4 substrates.
CONCLUSIONS


Linagliptin does not affect fasting renal hemodynamics compared with glimepiride in T2DM patients. DPP-4 inhibition promotes modest natriuresis, possibly mediated by SDF-1α, likely distal to the macula densa.",2020,"Linagliptin versus glimepiride did not affect GFR, ERPF, estimated intrarenal hemodynamics or damage-makers.","['metformin-treated patients with type 2 diabetes mellitus (T2DM', 'With Type 2 Diabetes (RENALIS', 'Overweight Patients', 'T2DM patients', '46 overweight T2DM patients without renal impairment received once']","['daily linagliptin', 'glimepiride', 'Linagliptin', 'linagliptin', 'sulfonylurea', 'dipeptidyl peptidase 4 (DPP-4) inhibitor linagliptin', 'DPP-4 Inhibitor Linagliptin Versus Sulfonylurea Glimepiride', 'Metformin']","['fractional excretion (FE) of sodium (FE Na ) and potassium FE K', 'Fasting glomerular filtration rate (GFR) and effective renal plasma flow (ERPF', 'renal physiology', 'Fractional excretions, urinary damage markers, and circulating DPP-4 substrates (among others, glucagon-like peptide 1 and stromal cell-derived factor-1α (SDF-1α', 'GFR, ERPF, estimated intrarenal hemodynamics or damage-makers', 'fasting renal hemodynamics', 'Renal Physiology']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0428601', 'cui_str': 'Measurement of fractional excretion of sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206088', 'cui_str': 'Effective renal plasma flow'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0554244', 'cui_str': 'Maker'}]",46.0,0.155817,"Linagliptin versus glimepiride did not affect GFR, ERPF, estimated intrarenal hemodynamics or damage-makers.","[{'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands ma.muskiet@amsterdamumc.nl.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'D Margriet', 'Initials': 'DM', 'LastName': 'Ouwens', 'Affiliation': 'Institute of Clinical Biochemistry and Pathobiochemistry, German Diabetes Center, Düsseldorf, Germany.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Panum Institute, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Amsterdam University Medical Centers, location VUmc, Amsterdam, the Netherlands.'}]",Diabetes care,['10.2337/dc20-0902']
2455,32901255,"Efficacy and safety of oral tolvaptan in patients undergoing hemodialysis: a Phase 2, double-blind, randomized, placebo-controlled trial.","BACKGROUND


Loop diuretics are used to manage fluid retention in patients with end-stage kidney disease undergoing hemodialysis (HD). This randomized, double-blind, placebo-controlled, Phase 2 trial evaluated the efficacy and safety of tolvaptan, a vasopressin V2 receptor antagonist, in Japanese HD patients.
METHODS


A total of 124 patients (24-h urine volume ≥500 mL) on thrice-weekly HD were randomized to receive oral tolvaptan 15 mg/day (n = 40), tolvaptan 30 mg/day (n = 40) or placebo (n = 44) for 24 weeks. Efficacy endpoints were change from baseline in 24-h urine volume, total fluid removal by HD per week and interdialytic weight gain (IDWG). Safety was assessed via the incidence of treatment-emergent adverse events (TEAEs).
RESULTS


At treatment end, the difference (95% confidence interval) from the placebo group in the mean change from baseline in 24-h urine volume was significant in the tolvaptan 15 mg {429.1 mL [95% confidence interval (CI) 231.0, 627.2]; P < 0.0001} and 30 mg [371.6 mL (95% CI 144.1, 599.2); P = 0.0017] groups. The mean changes from baseline in total fluid removal by HD and IDWG were not significantly different in the tolvaptan groups versus the placebo group. Although the proportion of patients with TEAEs was lower in the placebo group (77.3%) than in the tolvaptan groups (92.3%), tolvaptan was safe and well-tolerated during the study period.
CONCLUSIONS


Tolvaptan significantly sustained diuretic action for 24 weeks in HD patients but did not reduce total fluid removal by HD per week and IDWG to the same extent.",2020,The mean changes from baseline in total fluid removal by HD and IDWG were not significantly different in the tolvaptan groups versus the placebo group.,"['patients with end-stage kidney disease undergoing hemodialysis (HD', 'patients undergoing hemodialysis', '124 patients (24-h urine volume ≥500\u2009mL) on thrice-weekly HD', 'Japanese HD patients']","['oral tolvaptan', 'tolvaptan, a vasopressin V2 receptor antagonist', 'tolvaptan 30\u2009mg/day (n\u2009=\u200940) or placebo', 'mL', 'placebo']","['24-h urine volume', 'sustained diuretic action', 'Efficacy and safety', 'total fluid removal by HD and IDWG', 'total fluid removal', '24-h urine volume, total fluid removal by HD per week and interdialytic weight gain (IDWG', 'tolvaptan was safe and well-tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}, {'cui': 'C0162829', 'cui_str': 'V2 Receptors'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C2684746', 'cui_str': 'tolvaptan 30 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1176308', 'cui_str': 'tolvaptan'}]",124.0,0.488207,The mean changes from baseline in total fluid removal by HD and IDWG were not significantly different in the tolvaptan groups versus the placebo group.,"[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ogata', 'Affiliation': 'Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Shimofurutani', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co. Ltd, Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Headquarters of Clinical Development, Otsuka Pharmaceutical Co. Ltd, Osaka, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Nagamoto', 'Affiliation': 'Medical Affairs, Otsuka Pharmaceutical Co. Ltd, Tokushima, Japan.'}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa148']
2456,32901283,Variation in the pharmacokinetics of glucosamine in healthy individuals.,"OBJECTIVES


Clinical trial data for the efficacy of glucosamine in OA are conflicting. Reportedly, Rotta-manufactured glucosamine products are more likely to be effective, and a possible explanation is greater bioavailability than other brands. Specifically, the aim was to compare the steady-state pharmacokinetics of Rotta- and non-Rotta-manufactured glucosamine products in healthy volunteers and examine the interindividual variability.
METHODS


In a crossover design, healthy adult participants ingested 1500 mg/day of a Rotta (DONA powder sachets; imported by Mylan Health, Carole Park, QLD, Australia) and a non-Rotta (glucosamine sulphate 1500 mg one-a-day tablet; Blackmores, Warriewood, NSW, Australia) glucosamine product/brand individually for 6 days. Blood samples were collected immediately before and for 12 h after the ingestion of the last dose of each brand and analysed to determine plasma levels of glucosamine. The pharmacokinetic parameters at steady state [including the minimum (Css min) and maximum (Css max) plasma concentration of glucosamine, time to reach Css max post-dosing (Tss max) and area under the plasma concentration vs time curve (AUCss 0-12)] for each brand were calculated and statistically compared.
RESULTS


Fourteen participants [mean age 35.5 years (s.d. 8.8)] were recruited (64.2% males). No significant differences were observed in the pharmacokinetic parameters between the two brands. However, for both brands, the coefficient of variation for Css min, Tss max and AUCss 0-12 exceeded 20%, indicating considerable differences in the parameters between participants. No significant association of the pharmacokinetic parameters was observed with various dosing- and participant-related variables.
CONCLUSION


Substantial interindividual differences in the absorption and elimination of glucosamine could be a cause of variable clinical outcomes in OA.
TRIAL REGISTRATION


The study was registered with the Australian New Zealand Clinical Trials Registry (http://www.ANZCTR.org.au/ACTRN12618000699268p.aspx), number ACTRN12618000699268p.",2020,No significant differences were observed in the pharmacokinetic parameters between the two brands.,"['healthy adult participants', 'healthy volunteers', 'Fourteen participants [mean age 35.5\u2009years (s.d', '8.8)] were recruited (64.2% males', 'healthy individuals']","['ingested 1500\u2009mg/day of a Rotta (DONA powder sachets; imported by Mylan Health, Carole Park, QLD, Australia) and a non-Rotta (glucosamine sulphate 1500\u2009mg one-a-day tablet; Blackmores, Warriewood, NSW, Australia) glucosamine product/brand individually for 6\u2009days', 'glucosamine', 'Rotta- and non-Rotta-manufactured glucosamine products']","['pharmacokinetic parameters', 'Blood samples', 'pharmacokinetic parameters at steady state [including the minimum (Css min) and maximum (Css max) plasma concentration of glucosamine, time to reach Css max post-dosing (Tss max) and area under the plasma concentration vs time curve']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C1567628', 'cui_str': 'Dona S'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0474702', 'cui_str': 'Sulfate measurement'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017718', 'cui_str': 'Glucosamine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0438742,No significant differences were observed in the pharmacokinetic parameters between the two brands.,"[{'ForeName': 'Chhavi', 'Initials': 'C', 'LastName': 'Asthana', 'Affiliation': 'School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Peterson', 'Affiliation': 'School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Madhur D', 'Initials': 'MD', 'LastName': 'Shastri', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Rahul P', 'Initials': 'RP', 'LastName': 'Patel', 'Affiliation': 'School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa418']
2457,32901293,Highly sensitive serum cardiac troponin T and cardiovascular events in patients with systemic lupus erythematosus (TROPOPLUS study).,"OBJECTIVE


Identification of biological markers able to better stratify cardiovascular risks in SLE patients is needed. We aimed to determine whether serum cardiac troponin T (cTnT) levels measured with a highly sensitive assay [high sensitivity cTnT (HS-cTnT)] may predict cardiovascular events (CVEs) in SLE.
METHOD


All SLE patients included between 2007 and 2010 in the randomized, double-blind, placebo-controlled, multicentre PLUS trial were screened. Patients with no past history of CVE at inclusion and a follow-up period of >20 months were analysed. HS-cTnT concentration was measured using the electrochemiluminescence method on serum collected at PLUS inclusion. The primary outcome was the incident CVE. Factors associated with the primary outcome were identified and multivariate analysis was performed.
RESULTS


Overall, 442 SLE patients (of the 573 included in the PLUS study) were analysed for the primary outcome with a median follow up of 110 (interquartile range: 99-120) months. Among them, 29 (6.6%) experienced at least one CVE that occurred at a median of 67 (interquartile range: 31-91) months after inclusion. Six out of 29 patients had more than one CVE. In the multivariate analysis, dyslipidaemia, age and HS-cTnT were associated with the occurrence of CVE. Kaplan-Meier analysis showed that a concentration of HS-cTnT > 4.27 ng/l at inclusion increased by 2.7 [hazard ratio 2.7 (95% CI: 1.3, 5.6), P =0.0083] the risk of CVE in SLE.
CONCLUSION


HS-cTnT measured in serum is the first identified biomarker independently associated with incident CVE in SLE patients.",2020,"In the multivariate analysis, dyslipidaemia, age and HS-cTnT were associated with the occurrence of CVE.","['SLE patients', '29 patients had more than one CVE', 'Patients with no past history of CVE at inclusion and a follow-up period of >20\u2009months were analysed', '442 SLE patients (of the 573 included in the PLUS study', 'patients with systemic lupus erythematosus (TROPOPLUS study']",['placebo'],"['serum cardiac troponin T (cTnT', 'incident CVE', 'HS-cTnT concentration', 'Highly sensitive serum cardiac troponin T and cardiovascular events']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332124', 'cui_str': 'No past history of'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",442.0,0.562474,"In the multivariate analysis, dyslipidaemia, age and HS-cTnT were associated with the occurrence of CVE.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Chezel', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Costedoat-Chalumeau', 'Affiliation': 'Département de Médecine Interne, Hôpital Cochin, Centre de Reference Maladies Auto-immunes et Systémiques Rares, APHP, Université de Paris, CRESS, INSERM, INRA.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laouénan', 'Affiliation': ""Departement d'Epidémiologie et de Recherche Clinique, Hôpital Bichat.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Rouzaud', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Chenevier-Gobeaux', 'Affiliation': 'Service de Diagnostic Biologique Automatisé, Département médico-universitaire BioPhyGen, Hôpital Cochin, APHP, Université de Paris.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Le Guern', 'Affiliation': 'Département de Médecine Interne, Hôpital Cochin, Centre de Reference Maladies Auto-immunes et Systémiques Rares, APHP, Université de Paris, CRESS, INSERM, INRA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Mathian', 'Affiliation': 'Département de Médecine Interne 2, French National Referral Center for Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome and Other Autoimmune Disorders, Groupement Hospitalier Pitié-Salpêtrière, APHP, Sorbonne Université, Paris.'}, {'ForeName': 'Drifa', 'Initials': 'D', 'LastName': 'Belhadi', 'Affiliation': ""Departement d'Epidémiologie et de Recherche Clinique, Hôpital Bichat.""}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'de Almeida Chaves', 'Affiliation': 'Département de Médecine Interne, Hôpital Purpan, Centre Hospitalo-Universitaire (CHU) de Toulouse, Toulouse.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Duhaut', 'Affiliation': ""Département de Médecine Interne, Hôpital Amiens Nord, CHU d'Amiens, Amiens.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Fain', 'Affiliation': 'Département de Médecine Interne, Hôpital Saint Antoine, APHP, Université Pierre et Marie Curie.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Galicier', 'Affiliation': ""Département d'Immunologie Clinique, Hôpital Saint Louis, APHP, Université de Paris.""}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Ghillani-Dalbin', 'Affiliation': 'Département de Immunologie, Hôpital Pitié-Salpétrière, APHP, Université Pierre et Marie Curie, Paris.'}, {'ForeName': 'Jean Emmanuel', 'Initials': 'JE', 'LastName': 'Kahn', 'Affiliation': 'Département de Médecine Interne, Hôpital Ambroise Paré, APHP, Université de Versailles-Saint-Quentin en Yvelines, Versailles.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Morel', 'Affiliation': 'Département de Médecine Interne, Hôpital Cochin, Centre de Reference Maladies Auto-immunes et Systémiques Rares, APHP, Université de Paris, CRESS, INSERM, INRA.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Perard', 'Affiliation': 'Département de Médecine Interne, Hôpital St Joseph St Luc, Lyon.'}, {'ForeName': 'Micheline', 'Initials': 'M', 'LastName': 'Pha', 'Affiliation': 'Département de Médecine Interne 2, French National Referral Center for Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome and Other Autoimmune Disorders, Groupement Hospitalier Pitié-Salpêtrière, APHP, Sorbonne Université, Paris.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Saidoune', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris.'}, {'ForeName': 'Francoise', 'Initials': 'F', 'LastName': 'Sarrot-Reynauld', 'Affiliation': 'Département de médecine interne, Hôpital Michallon, CHU de Grenoble Alpes, Grenoble.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Aumaitre', 'Affiliation': 'Département de médecine interne, Hôpital Gabriel-Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Chasset', 'Affiliation': 'Département de médecine interne, Hôpital Tenon, APHP Université Pierre et Marie Curie.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Limal', 'Affiliation': 'Département de médecine interne, Hôpital Henri Mondor, APHP Université Paris-Est Créteil, Paris.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Desmurs-Clavel', 'Affiliation': 'Département de médecine interne, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ackermann', 'Affiliation': 'Département de médecine interne, Hôpital Foch, Suresnes, France.'}, {'ForeName': 'Zahir', 'Initials': 'Z', 'LastName': 'Amoura', 'Affiliation': 'Département de Médecine Interne 2, French National Referral Center for Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome and Other Autoimmune Disorders, Groupement Hospitalier Pitié-Salpêtrière, APHP, Sorbonne Université, Paris.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Papo', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Sacre', 'Affiliation': 'Département de Médecine Interne, Hôpital Bichat, Assistance Publique Hôpitaux de Paris (APHP), Institut national de la santé et de la recherche médicale (INSERM) U1149, Université de Paris.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa434']
2458,32901299,Randomized clinical trial of pancreaticogastrostomy versus pancreaticojejunostomy regarding incidence of delayed gastric emptying after pancreaticoduodenectomy.,"PURPOSE


Delayed gastric emptying (DGE) is an important postoperative complication after pancreaticoduodenectomy (PD), and its incidence may be associated with the utilized surgical procedures. Compared with pancreaticojejunostomy (PJ) after PD, it may be speculated that pancreaticogastrostomy (PG) is a risk factor for DGE, because it needs an anastomosis of the remnant pancreas to the back wall of the stomach. This study aimed to compare PG and PJ with regard to the incidence of DGE after PD.
METHODS


We performed a prospective open-label randomized clinical trial (RCT) including patients undergoing elective pancreaticoduodenectomy, who were randomly assigned PG or PJ the day before surgery. The primary endpoint was incidence of DGE.
RESULTS


The study included 60 patients (30 PG, 30 PJ), of whom seven were deemed unresectable, one was enucleated, and one was switched from PJ to PG during surgery according to the surgeon's decision. Thus, modified intention-to-treat analyses were performed in 27 PG patients and 26 PJ patients. DGE occurred in three patients in the PG group and six patients in the PJ group, which did not constitute a significant between-group difference (P = 0.42). In the PG group, two cases were ISGPS grade A DGE and one was grade C. In the PJ group, one case was grade A, two grade B, and three grade C. The two groups also did not significantly differ in the incidence of other morbidities or postoperative hospital stay.
CONCLUSIONS


Post-PD DGE incidences were similar after PG and PJ.",2020,"The two groups also did not significantly differ in the incidence of other morbidities or postoperative hospital stay.
","['27 PG patients and 26 PJ patients', 'patients undergoing elective pancreaticoduodenectomy, who were randomly assigned PG or PJ the day before surgery', ""60 patients (30 PG, 30 PJ), of whom seven were deemed unresectable, one was enucleated, and one was switched from PJ to PG during surgery according to the surgeon's decision""]","['pancreaticojejunostomy (PJ', 'pancreaticogastrostomy versus pancreaticojejunostomy']","['incidence of DGE', 'incidence of other morbidities or postoperative hospital stay', 'ISGPS grade', 'delayed gastric emptying', 'DGE']","[{'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0030303', 'cui_str': 'Pancreaticojejunostomy'}, {'cui': 'C1533621', 'cui_str': 'Pancreas to stomach anastomosis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",60.0,0.118862,"The two groups also did not significantly differ in the incidence of other morbidities or postoperative hospital stay.
","[{'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. heguchi@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Iwagami', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Tomimaru', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Akita', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Noda', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Kunihito', 'Initials': 'K', 'LastName': 'Gotoh', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Nagano', 'Affiliation': 'Clinical Study Group of Osaka University, Hepato-Biliary-Pancreatic Group, Osaka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Clinical Study Group of Osaka University, Hepato-Biliary-Pancreatic Group, Osaka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01982-0']
2459,32901379,Evaluation of photobiomodulation therapy to accelerate bone formation in the mid palatal suture after rapid palatal expansion: a randomized clinical trial.,"To evaluate the efficiency of photobiomodulation therapy (PBMT) in the midpalatal suture (MPS) and pain sensation in patients undergoing rapid palatal expansion (RPE). Thirty-four individuals with the diagnosis of skeletal maxillary hypoplasia were divided in two groups: laser (n = 18) and control (n = 16). Treatment plan consisted of the use of the Hyrax expander in all patients. Subjects in the laser group were irradiated with diode laser (980 nm, 0.3 W) in six spots bilaterally distributed along the MPS for 10 s during the active phase of treatment and after overcorrection (passive phase of RPE). Control group received sham irradiations with the laser in standby mode to characterize the placebo effect. Digital occlusal radiographs were performed at different time-points for bone formation evaluation in both groups. The effects of laser irradiation on pain were assessed by the visual analog scale (Wong-Baker Faces Pain Scale). Bone formation between groups was not significantly different (p = 0.2273). At 3 months, bone formation was not yet complete in both groups. Pain sensation was similar between groups (p = 0.3940). However, pain was significantly higher for the first 7 days of treatment compared with the 14th day. PBMT did not accelerate bone regeneration in the MPS and pain sensation was similar.",2020,Bone formation between groups was not significantly different (p = 0.2273).,"['patients undergoing rapid palatal expansion (RPE', 'Thirty-four individuals with the diagnosis of skeletal maxillary hypoplasia', 'mid palatal suture after rapid palatal expansion']","['laser irradiation', 'photobiomodulation therapy', 'photobiomodulation therapy (PBMT', 'diode laser', 'PBMT']","['bone formation', 'pain sensation', 'bone regeneration', 'Pain sensation', 'Bone formation', 'visual analog scale (Wong-Baker Faces Pain Scale', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0240310', 'cui_str': 'Maxillary hypoplasia'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",34.0,0.0418796,Bone formation between groups was not significantly different (p = 0.2273).,"[{'ForeName': 'Denise Souza', 'Initials': 'DS', 'LastName': 'Matos', 'Affiliation': 'School of Dentistry, University Center of Patos de Minas, Patos de Minas, MG, Brazil.'}, {'ForeName': 'Regina Guenka', 'Initials': 'RG', 'LastName': 'Palma-Dibb', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirao Preto, São Paulo, Brazil.'}, {'ForeName': 'Christiano', 'Initials': 'C', 'LastName': 'de Oliveira Santos', 'Affiliation': 'Department of Stomatology, Public Health and Forensic Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirao Preto, São Paulo, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Conceição Pereira Saraiva', 'Affiliation': 'Department of Paediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Av. Do Café, s/n. Monte Alegre, Ribeirao Preto, SP, Brazil.'}, {'ForeName': 'Fernanda Vicioni', 'Initials': 'FV', 'LastName': 'Marques', 'Affiliation': 'Department of Paediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Av. Do Café, s/n. Monte Alegre, Ribeirao Preto, SP, Brazil.'}, {'ForeName': 'Mírian Aiko Nakane', 'Initials': 'MAN', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Paediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Av. Do Café, s/n. Monte Alegre, Ribeirao Preto, SP, Brazil.'}, {'ForeName': 'Fábio Lourenço', 'Initials': 'FL', 'LastName': 'Romano', 'Affiliation': 'Department of Paediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Av. Do Café, s/n. Monte Alegre, Ribeirao Preto, SP, Brazil. fabioromano@forp.usp.br.'}]",Lasers in medical science,['10.1007/s10103-020-03141-9']
2460,32901440,The LEAP Program: Quality Improvement Training to Address Team Readiness Gaps Identified by Implementation Science Findings.,"BACKGROUND


Integrating evidence-based innovations (EBIs) into sustained use is challenging; most implementations in health systems fail. Increasing frontline teams' quality improvement (QI) capability may increase the implementation readiness and success of EBI implementation.
OBJECTIVES


Develop a QI training program (""Learn. Engage. Act. Process."" (LEAP)) and evaluate its impact on frontline obesity treatment teams to improve treatment delivered within the Veterans Health Administration (VHA).
DESIGN


This was a pre-post evaluation of the LEAP program. MOVE! coordinators (N = 68) were invited to participate in LEAP; 24 were randomly assigned to four starting times. MOVE! coordinators formed teams to work on improvement aims. Pre-post surveys assessed team organizational readiness for implementing change and self-rated QI skills. Program satisfaction, assignment completion, and aim achievement were also evaluated.
PARTICIPANTS


VHA facility-based MOVE! teams.
INTERVENTIONS


LEAP is a 21-week QI training program. Core components include audit and feedback reports, structured curriculum, coaching and learning community, and online platform.
MAIN MEASURES


Organizational readiness for implementing change (ORIC); self-rated QI skills before and after LEAP; assignment completion and aim achievement; program satisfaction.
KEY RESULTS


Seventeen of 24 randomized teams participated in LEAP. Participants' self-ratings across six categories of QI skills increased after completing LEAP (p< 0.0001). The ORIC measure showed no statistically significant change overall; the change efficacy subscale marginally improved (p < 0.08), and the change commitment subscale remained the same (p = 0.66). Depending on the assignment, 35 to 100% of teams completed the assignment. Nine teams achieved their aim. Most team members were satisfied or very satisfied (81-89%) with the LEAP components, 74% intended to continue using QI methods, and 81% planned to continue improvement work.
CONCLUSIONS


LEAP is scalable and does not require travel or time away from clinical responsibilities. While QI skills improved among participating teams and most completed the work, they struggled to do so amid competing clinical priorities.",2020,Participants' self-ratings across six categories of QI skills increased after completing LEAP (p< 0.0001).,"['Seventeen of 24 randomized teams participated in LEAP', 'VHA facility-based MOVE', 'coordinators (N = 68) were invited to participate in LEAP; 24']","['QI training program (""Learn']","['Organizational readiness for implementing change (ORIC); self-rated QI skills', 'change commitment subscale', 'self-ratings across six categories of QI skills', 'QI skills', 'change efficacy subscale']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0029246', 'cui_str': 'Organizations'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",68.0,0.036767,Participants' self-ratings across six categories of QI skills increased after completing LEAP (p< 0.0001).,"[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Damschroder', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA. Laura.Damschroder@va.gov.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Yankey', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Claire H', 'Initials': 'CH', 'LastName': 'Robinson', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Michelle B', 'Initials': 'MB', 'LastName': 'Freitag', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Burns', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Raffa', 'Affiliation': 'National Center for Health Promotion and Disease Prevention, Veterans Health Administration, Washington, DC, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lowery', 'Affiliation': 'Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06133-1']
2461,32901464,Imaging Predictors of Survival in Patients with Single Small Hepatocellular Carcinoma Treated with Transarterial Chemoembolization.,"OBJECTIVE


Clinical outcomes of patients who undergo transarterial chemoembolization (TACE) for single small hepatocellular carcinoma (HCC) are not consistent, and may differ based on certain imaging findings. This retrospective study was aimed at determining the efficacy of pre-TACE CT or MR imaging findings in predicting survival outcomes in patients with small HCC upon being treated with TACE. Besides, the study proposed to build a risk prediction model for these patients.
MATERIALS AND METHODS


Altogether, 750 patients with functionally good hepatic reserve who received TACE as the first-line treatment for single small HCC between 2004 and 2014 were included in the study. These patients were randomly assigned into training (n = 525) and validation (n = 225) sets.
RESULTS


According to the results of a multivariable Cox analysis, three pre-TACE imaging findings (tumor margin, tumor location, enhancement pattern) and two clinical factors (age, serum albumin level) were selected and scored to create predictive models for overall, local tumor progression (LTP)-free, and progression-free survival in the training set. The median overall survival time in the validation set were 137.5 months, 76.1 months, and 44.0 months for low-, intermediate-, and high-risk groups, respectively ( p  < 0.001). Time-dependent receiver operating characteristic curves of the predictive models for overall, LTP-free, and progression-free survival applied to the validation cohort showed acceptable areas under the curve values (0.734, 0.802, and 0.775 for overall survival; 0.738, 0.789, and 0.791 for LTP-free survival; and 0.671, 0.733, and 0.694 for progression-free survival at 3, 5, and 10 years, respectively).
CONCLUSION


Pre-TACE CT or MR imaging findings could predict survival outcomes in patients with small HCC upon treatment with TACE. Our predictive models including three imaging predictors could be helpful in prognostication, identification, and selection of suitable candidates for TACE in patients with single small HCC.",2020,Pre-TACE CT or MR imaging findings could predict survival outcomes in patients with small HCC upon treatment with TACE.,"['patients with small HCC upon being treated with TACE', 'Altogether, 750 patients with functionally good hepatic reserve who received TACE as the first-line treatment for single small HCC between 2004 and 2014 were included in the study', 'Patients with Single Small Hepatocellular Carcinoma Treated with', 'patients with small HCC upon treatment with TACE', 'patients with single small HCC', 'patients who undergo']","['Transarterial Chemoembolization', 'Pre-TACE CT or MR imaging', 'pre-TACE CT or MR imaging', 'transarterial chemoembolization (TACE']","['survival outcomes', 'median overall survival time', 'local tumor progression (LTP)-free, and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",750.0,0.0284806,Pre-TACE CT or MR imaging findings could predict survival outcomes in patients with small HCC upon treatment with TACE.,"[{'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Hyoung', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jhkimrad@amc.seoul.kr.'}, {'ForeName': 'Pyeong Hwa', 'Initials': 'PH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Il', 'Initials': 'DI', 'LastName': 'Gwon', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hee Ho', 'Initials': 'HH', 'LastName': 'Chu', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Minho', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joonho', 'Initials': 'J', 'LastName': 'Hur', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Korean journal of radiology,['10.3348/kjr.2020.0325']
2462,32901695,In vitro remineralization of primary teeth with a mineralization-promoting peptide containing dental varnish.,"Mineralization-promoting peptides are attractive candidates for new remineralization systems. In previous studies, peptides have been applied as aqueous solutions, which is not a clinically relevant form.
OBJECTIVE


This study aims to investigate the efficiency of a mineralization-promoting peptide, applied in varnish, on remineralizing artificial caries on primary teeth.
METHODOLOGY


55 primary molars were collected. Specimens were immersed in a demineralizing solution for 7 days and then, divided into 7 groups: Baseline: No-remineralization, Placebo: Blank colophony, F: Colophony 5% fluoride, P: Colophony 10% peptide, P+F: Colophony 5% fluoride and 10% peptide, Embrace: Embrace™ varnish, Durashield: Durashield™ varnish. A mixture of 35% w/v colophony varnishes were prepared in ethanol and applied accordingly. Specimens were immersed in a remineralization solution for 4 weeks and it was evaluated using PLM and SEM. Lesion depth reduction was examined by one-way ANOVA.
RESULTS


There was no significant difference in mean lesion depths between baseline (147.04 ± 10.18 μm) and placebo groups (139.73 ± 14.92 μm), between F (120.95 ± 12.23 μm) and Durashield (113.47 ± 14.36 μm) groups and between P (81.79 ± 23.15 μm) and Embrace (90.26 ± 17.72 μm) groups. Lesion depth for the P+F group (66.95±10.59 μm) was significantly higher compared to all other groups. All groups contained samples with subsurface demineralized regions. Number of subsurface demineralized regions were higher in fluoride-containing groups.
CONCLUSIONS


We conclude that the mineralization-promoting peptide (MPP3) is effective in this in vitro study and the peptide shows benefits over fluoride as it yields less subsurface demineralized regions.",2020,Lesion depth for the P+F group (66.95±10.59 μm) was significantly higher compared to all other groups.,"['55 primary molars were collected', 'remineralizing artificial caries on primary teeth', 'primary teeth with a mineralization-promoting peptide containing dental varnish']","['placebo', 'Baseline: No-remineralization, Placebo: Blank colophony, F: Colophony 5% fluoride, P: Colophony 10% peptide, P+F: Colophony 5% fluoride and 10% peptide, Embrace: Embrace™ varnish, Durashield: Durashield™ varnish']","['Lesion depth reduction', 'mean lesion depths', 'Lesion depth', 'Number of subsurface demineralized regions']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0440150', 'cui_str': 'Dental varnish'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0073589', 'cui_str': 'rosin'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0042359', 'cui_str': 'Varnish'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",55.0,0.0672111,Lesion depth for the P+F group (66.95±10.59 μm) was significantly higher compared to all other groups.,"[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tulumbaci', 'Affiliation': 'Ankara Yildirim Beyazit University, School of Dentistry, Department of Pediatric Dentistry, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Gungormus', 'Affiliation': 'Ankara Yildirim Beyazit University, School of Dentistry, Department of Basic Sciences, Ankara, Turkey.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0259']
2463,32901709,Effect of Occlusal Adjustment on Postoperative Pain after Root Canal Treatment: A Randomized Clinical Trial.,"The aim of this prospective, randomized, clinical study was to analyze the influence of occlusal adjustment on the prevalence of postoperative pain after endodontic treatment. Seventy-eight patients, diagnosed with symptomatic irreversible pulpitis with indication for endodontic treatment, were selected to participate in the study. The participants were randomized and divided into two groups: in the occlusal adjustment group (OAG), endodontic treatment was performed with subsequent occlusal adjustment. In the control group (CG), endodontic treatment was performed without occlusal adjustment. Treatments were performed by the same operator. Pain occurrence and intensity were recorded on two scales: the verbal rating scale (VRS) and numerical rating scale (NRS). Pain assessment was carried out by a second examiner, blinded to the experiment, 6, 24 and 72 h after endodontic treatment. Data were analyzed using Mann-Whitney, chi-squared, and Fisher's exact tests. In the occlusal adjustment group, 71.1% reported postoperative pain and 67.5% reported pain in the control group. At the 6-hour assessment, 21 individuals reported pain in the occlusal adjustment group and 24 in the control group (p=0.672). At the 24-hour assessment, 18 and 19 individuals reported pain (p=0.991) and at the 72-hour assessment, 8 and 4 reported pain (p=0.219), respectively. Occlusal adjustment did not influence the prevalence of postoperative pain of endodontically treated teeth with symptomatic irreversible pulpitis.",2020,"At the 6-hour assessment, 21 individuals reported pain in the occlusal adjustment group and 24 in the control group (p=0.672).","['Seventy-eight patients, diagnosed with symptomatic irreversible pulpitis with indication for endodontic treatment']","['occlusal adjustment group (OAG), endodontic treatment was performed with subsequent occlusal adjustment', 'Occlusal Adjustment']","['verbal rating scale (VRS) and numerical rating scale (NRS', 'Pain occurrence and intensity', 'Pain assessment', 'Postoperative Pain', 'postoperative pain', 'pain']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}]","[{'cui': 'C0341000', 'cui_str': 'Occlusal adjustment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",78.0,0.0473883,"At the 6-hour assessment, 21 individuals reported pain in the occlusal adjustment group and 24 in the control group (p=0.672).","[{'ForeName': 'Elizângela Cristina Barbosa', 'Initials': 'ECB', 'LastName': 'Vianna', 'Affiliation': 'Dental school, UFAM - Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Fernando José', 'Initials': 'FJ', 'LastName': 'Herkrath', 'Affiliation': 'Leônidas & Maria Deane Institute, Oswaldo Cruz Foundation, Manaus, AM, Brazil.'}, {'ForeName': 'Izabelly Esteves Bittencourt', 'Initials': 'IEB', 'LastName': 'Martins', 'Affiliation': 'Dental school, UFAM - Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Luana Pontes Barros', 'Initials': 'LPB', 'LastName': 'Lopes', 'Affiliation': 'Dental school, UFAM - Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'André Augusto Franco', 'Initials': 'AAF', 'LastName': 'Marques', 'Affiliation': 'Dental school, UFAM - Federal University of Amazonas, Manaus, AM, Brazil.'}, {'ForeName': 'Emílio Carlos', 'Initials': 'EC', 'LastName': 'Sponchiado Júnior', 'Affiliation': 'Dental school, UFAM - Federal University of Amazonas, Manaus, AM, Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202003248']
2464,32901722,Does Pigment Incorporation into Regular Composite Resins for Posterior Buildups Alter Their Bond Strength?,"Posterior build-ups are auxiliary devices to orthodontic treatment which are made with resin-based or glass ionomer composites. Their removal requires care to protect the tooth surface, therefore, pigmented materials are preferred for a better visualization. This study proposed a pigmentation experimental technique of a regular composite resin, evaluating the microshear bond strength test (µ-SBT) of this experimental pigmented resin and comparing with a blue-colored polyacid-modified composite resin, used for posterior buildups. Forty-eight buccal and lingual surfaces of human teeth were used and randomly divided into 4 groups (n=12). The groups were divided into: C (control), regular composite resin; P, regular composite resin pigmented; UBL, Ultra Band Lok™; OB, Ortho Bite™. The composites were bonded using a matrix to obtain microcylinders and prepared for each experimental groups. The samples were then stored in distilled water for 24h at 37°C followed by a µ-SBT. The types of bond failures were evaluated using a stereoscopic magnifying glass (10×). The data were analyzed by ANOVA with Fisher post hoc and Dunnett´s test. Means of µ-SBT± standard deviation (MPa) were: C (39.98a±13.0), P (40.09a± 14.3); UBL (33.26ab±8.6); OB (28.70b±5.5). The most prevalent type of failure was adhesive (80.4%). Further, was not observed a statistically significant correlation between the bond strength values and failure patterns. The pigmentation of a commercially available resin did not alter the µ-SBT and exhibited similar adhesiveness as a polyacid-modified composite resin.",2020,The pigmentation of a commercially available resin did not alter the µ-SBT and exhibited similar adhesiveness as a polyacid-modified composite resin.,['Forty-eight buccal and lingual surfaces of human teeth'],"['regular composite resin; P, regular composite resin pigmented; UBL, Ultra Band Lok™; OB, Ortho Bite™', 'blue-colored polyacid-modified composite resin']",['bond strength values and failure patterns'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0447311', 'cui_str': 'Structure of lingual surface of tooth'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C1702125', 'cui_str': 'Ultra Band-Lok'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0752145', 'cui_str': 'Polyacid-Modified Composite Resins'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",48.0,0.0140122,The pigmentation of a commercially available resin did not alter the µ-SBT and exhibited similar adhesiveness as a polyacid-modified composite resin.,"[{'ForeName': 'Flaviana Alves', 'Initials': 'FA', 'LastName': 'Dias', 'Affiliation': 'Department of Restorative Dentistry, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}, {'ForeName': 'Maria Verônica Rodrigues', 'Initials': 'MVR', 'LastName': 'Conto', 'Affiliation': 'Department of Restorative Dentistry, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}, {'ForeName': 'Ricardo Danil', 'Initials': 'RD', 'LastName': 'Guiraldo', 'Affiliation': 'Department of Restorative Dentistry, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Geha', 'Affiliation': 'Department of Restorative Dentistry, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}, {'ForeName': 'Eloisa Aparecida Carlesse', 'Initials': 'EAC', 'LastName': 'Paloco', 'Affiliation': 'Department of Restorative Dentistry, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}, {'ForeName': 'Thais Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Orthodontics, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}, {'ForeName': 'Sandrine Bittencourt', 'Initials': 'SB', 'LastName': 'Berger', 'Affiliation': 'Department of Restorative Dentistry, Universidade do Norte do Paraná, UNOPAR - Londrina, PR, Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202003332']
2465,32901733,Split crest technique for implant treatment of agenesis of the upper lateral incisors: results of a randomized pilot histological and clinical study at 24-month follow-up.,"Agenesis of lateral incisors, besides the functional issues, represents a great esthetic drawback. The selection of an appropriate treatment is a complex decision, which should consider the stability of the clinical outcomes over time. The aim of the present study was a histological and clinical comparison of two-stage split crest technique (SCT), with bone chips alone or mixed with porcine bone in patients affected by unilateral and bilateral agenesis of the upper lateral incisors. Eleven patients were enrolled, and randomly assigned to receive a treatment with autologous bone chips (group 1) or autologous bone chips mixed 1:1 to porcine-derived xenogenic bone (group 2). After a 2-month healing period, implants were placed and biopsies harvested for histomorphometrical evaluation. Clinical assessment, according to ICOI PISA health scale, and radiographic marginal bone loss evaluation at 12- and 24-month follow-ups were conducted. The histomorphometry showed significantly greater new bone formation (p > 0.0229) in group 2. At 12- and 24-month follow-ups, all the evaluated implants, regardless of the group they were allocated, could be categorized as ""success"" in the ICOI Pisa Health Scale for Dental Implants, and did not show significant difference in crestal bone loss. To the best of our knowledge, these are the first histological and clinical outcomes indicating that the use of bone chips mixed 1:1 to porcine bone in SCT could be a promising technique for the rehabilitation of patients with agenesis of the upper lateral incisors, although studies with a larger number of patients and implants, and a longer follow up are needed.",2020,The histomorphometry showed significantly greater new bone formation (p > 0.0229) in group 2.,"['agenesis of the upper lateral incisors', 'Eleven patients', 'patients with agenesis of the upper lateral incisors', 'patients affected by unilateral and bilateral agenesis of the upper lateral incisors']","['autologous bone chips (group 1) or autologous bone chips mixed 1:1 to porcine-derived xenogenic bone', 'two-stage split crest technique (SCT), with bone chips alone or mixed with porcine bone', 'Split crest technique']","['crestal bone loss', 'ICOI PISA health scale, and radiographic marginal bone loss evaluation', 'new bone formation']","[{'cui': 'C0000846', 'cui_str': 'Agenesis'}, {'cui': 'C0227040', 'cui_str': 'Structure of maxillary right lateral incisor tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0206138', 'cui_str': 'CREST syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",11.0,0.0304187,The histomorphometry showed significantly greater new bone formation (p > 0.0229) in group 2.,"[{'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Iezzi', 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Perrotti', 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Adriano', 'Initials': 'A', 'LastName': 'Piattelli', 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': ""D'Arcangelo"", 'Affiliation': 'University of Chieti-Pescara Department of Medical, Oral and Biotechnological Sciences, Chieti, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Altieri', 'Affiliation': 'Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Rome, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cassetta', 'Affiliation': 'Sapienza University of Rome, Department of Oral and Maxillofacial Sciences, Rome, Italy.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0118']
2466,32907392,Better balance: a randomised controlled trial of oculomotor and gaze stability exercises to reduce risk of falling after stroke.,"OBJECTIVE


To assess the effect of a domiciliary program of oculomotor and gaze stability exercises on the incidence of falls and risk of fall in stroke survivors.
DESIGN


Two-arm, non-blinded parallel randomized controlled trial.
SUBJECTS


Stroke survivors older than 60 years, with positive Romberg test and autonomous gait after the stroke.
SETTING


Physiotherapy outpatient clinic of a tertiary care hospital.
INTERVENTIONS


Every participant accomplished the current rehabilitation program; the intervention group was randomly allocated into an additional three weeks intervention with a domiciliary program of oculomotor and gaze stability exercises.
MAIN MEASURES


Primary outcome was the incidence of falls through the three weeks after the intervention started; in addition, the variation of the estimated risk for falling assessed by both Berg Balance Scale (four points) and Timed Up and Go Test (four seconds) was the secondary outcome.
RESULTS


79 patients were recruited and 68 completed the protocol (control group 35; intervention group 33). During the follow up, falls were registered in 4/35 participants in the control group and no event occurred in the intervention group ( P  = 0.064). The estimated risk for falling decreased in 11/35 control group participants and in 28/33 intervention group participants (RR 0.37; 95%CI 0.22-0.62;  P  < 0.001).
CONCLUSION


After three weeks of a domiciliary program of oculomotor and gaze stability exercises, the estimated risk of falling significantly diminished and no falls occurred among the intervention group. These findings encourage further exploration of this promising intervention.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02280980.",2020,"During the follow up, falls were registered in 4/35 participants in the control group and no event occurred in the intervention group ( P  = 0.064).","['79 patients were recruited and 68 completed the protocol (control group 35; intervention group 33', 'Stroke survivors older than 60\u2009years, with positive Romberg test and autonomous gait after the stroke', 'Physiotherapy outpatient clinic of a tertiary care hospital']","['oculomotor and gaze stability exercises', 'domiciliary program of oculomotor and gaze stability exercises']","['variation of the estimated risk for falling assessed by both Berg Balance Scale (four points) and Timed Up and Go Test', 'incidence of falls', 'estimated risk for falling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278127', 'cui_str': 'Romberg sign'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0338047', 'cui_str': 'Domiciliary'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",79.0,0.119286,"During the follow up, falls were registered in 4/35 participants in the control group and no event occurred in the intervention group ( P  = 0.064).","[{'ForeName': 'Anabela', 'Initials': 'A', 'LastName': 'Correia', 'Affiliation': 'Physiotherapy, Hospital Curry Cabral, Centro Hospitalar Universitário Lisboa Central, Lisboa, Portugal. Teaching and Research Unit of Physiotherapy and Rehabilitation, Escola Superior de Tecnologia da Saúde de Lisboa, Instituto Politécnico de Lisboa, Portugal.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Pimenta', 'Affiliation': 'Physiotherapy, Hospital Curry Cabral, Centro Hospitalar Universitário Lisboa Central, Lisboa, Portugal. Teaching and Research Unit of Physiotherapy and Rehabilitation, Escola Superior de Tecnologia da Saúde de Lisboa, Instituto Politécnico de Lisboa, Portugal.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': 'Epidemiology and Statistics Office of the Research Unit, Centro Hospitalar Universitário Lisboa Central, Lisboa, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Virella', 'Affiliation': 'Epidemiology and Statistics Office of the Research Unit, Centro Hospitalar Universitário Lisboa Central, Lisboa, Portugal.'}]",Clinical rehabilitation,['10.1177/0269215520956338']
2467,32907393,Experiences of augmented arm rehabilitation including supported self-management after stroke: a qualitative investigation.,"OBJECTIVE


To explore the experiences of stroke survivors and their carers of augmented arm rehabilitation including supported self-management in terms of its acceptability, appropriateness and relevance.
DESIGN


A qualitative design, nested within a larger, multi-centre randomized controlled feasibility trial that compared augmented arm rehabilitation starting at three or nine weeks after stroke, with usual care. Semi-structured interviews were conducted with participants in both augmented arm rehabilitation groups. Normalization Process Theory was used to inform the topic guide and map the findings. Framework analysis was applied.
SETTING


Interviews were conducted in stroke survivors' homes, at Glasgow Caledonian University and in hospital.
PARTICIPANTS


17 stroke survivors and five carers were interviewed after completion of augmented arm rehabilitation.
INTERVENTION


Evidence-based augmented arm rehabilitation (27 additional hours over six weeks), including therapist-led sessions and supported self-management.
RESULTS


Three main themes were identified: (1) acceptability of the intervention (2) supported self-management and (3) coping with the intervention. All stroke survivors coped well with the intensity of the augmented arm rehabilitation programme. The majority of stroke survivors engaged in supported self-management and implemented activities into their daily routine. However, the findings suggest that some stroke survivors (male >70 years) had difficulties with self-management, needing a higher level of support.
CONCLUSION


Augmented arm rehabilitation commencing within nine weeks post stroke was reported to be well tolerated. The findings suggested that supported self-management seemed acceptable and appropriate to those who saw the relevance of the rehabilitation activities for their daily lives, and embedded them into their daily routines.",2020,"The findings suggested that supported self-management seemed acceptable and appropriate to those who saw the relevance of the rehabilitation activities for their daily lives, and embedded them into their daily routines.","[""Interviews were conducted in stroke survivors' homes, at Glasgow Caledonian University and in hospital"", '17 stroke survivors and five carers were interviewed after completion of augmented arm rehabilitation']","['Evidence-based augmented arm rehabilitation (27 additional hours over six weeks), including therapist-led sessions and supported self-management']",['tolerated'],"[{'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]",[],,0.0586311,"The findings suggested that supported self-management seemed acceptable and appropriate to those who saw the relevance of the rehabilitation activities for their daily lives, and embedded them into their daily routines.","[{'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schnabel', 'Affiliation': 'Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, UK.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'van Wijck', 'Affiliation': 'Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, UK.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Bain', 'Affiliation': 'Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Barber', 'Affiliation': 'Medicine for the Elderly and Stroke, NHS Lanarkshire, University Hospital Monklands, Monkscourt Avenue, Airdrie, South Lanarkshire, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Dall', 'Affiliation': 'Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'Different Strokes, Different Strokes Central Services, 9 Canon Harnett Court, Wolverton Mill, Milton Keynes, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kerr', 'Affiliation': 'Bioengineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Langhorne', 'Affiliation': 'Geriatric Medicine, Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Molloy', 'Affiliation': 'Different Strokes, Different Strokes Central Services, 9 Canon Harnett Court, Wolverton Mill, Milton Keynes, UK.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Heather Jane', 'Initials': 'HJ', 'LastName': 'Young', 'Affiliation': 'Centre for Living, School of Health and Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kidd', 'Affiliation': 'School of Medicine, Dentistry & Nursing, College of Medical, Veterinary & Life Sciences, University of Glasgow, Glasgow, UK.'}]",Clinical rehabilitation,['10.1177/0269215520956388']
2468,32907399,Feasibility and acceptability of a telephone and web-based stroke caregiver intervention: a pilot randomized controlled trial of the RESCUE intervention.,"OBJECTIVE


Assess the feasibility and acceptability of an Internet and telephone support and problem-solving intervention for stroke caregivers.
DESIGN


Randomized controlled pilot trial with four arms: four-week intervention ( n  = 13), eight-week intervention ( n  = 13), eight-week attention control ( n  = 13), and standard care ( n  = 14).
SETTING


Southeastern U.S. Veterans Health System.
PARTICIPANTS


Informal caregivers of Veterans who suffered a stroke in the preceding 2.5 years were enrolled over an 18-month period.
INTERVENTIONS


Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses. Attention control participants received active listening with no advice delivered by nurses via telephone.
MAIN MEASURES


Feasibility of a larger trial was assessed via recruitment and retention. Acceptability was assessed using an adapted enactment tool and qualitative interviews. Changes in caregiver depressive symptoms and burden were measured by the Center for Epidemiologic Studies Depression Scale and Zarit Burden Interview. The study was not powered for significance testing.
RESULTS


Of 340 eligible caregivers, 53 (16%) agreed to participate. Among those enrolled, 51 (96%) completed the study. Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white. At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden. Acceptability and enactment tool findings indicated positive participant responses to the intervention. Most rated the amount of sessions the ""right amount"". Qualitative analysis revealed the intervention was valued by and acceptable to caregivers.
CONCLUSIONS


Findings indicate the RESCUE intervention is feasible and acceptable to caregivers and warrants further testing.",2020,"At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden.","['Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white', 'stroke caregivers', 'Informal caregivers of Veterans who suffered a stroke in the preceding 2.5\u2009years were enrolled over an 18-month period', 'Southeastern U.S. Veterans Health System', '340 eligible caregivers, 53 (16%) agreed to participate']","['Internet and telephone support and problem-solving intervention', 'active listening with no advice delivered by nurses via telephone', 'Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses', 'telephone and web-based stroke caregiver intervention']","['Feasibility and acceptability', 'Acceptability', 'feasibility and acceptability', 'high risk of depression']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",340.0,0.110904,"At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden.","[{'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'LeLaurin', 'Affiliation': 'Research Service, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}, {'ForeName': 'I Magaly', 'Initials': 'IM', 'LastName': 'Freytes', 'Affiliation': 'Research Service, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Findley', 'Affiliation': 'Research Service, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}, {'ForeName': 'Magda K', 'Initials': 'MK', 'LastName': 'Schmitzberger', 'Affiliation': 'Research Service, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}, {'ForeName': 'Nathaniel D', 'Initials': 'ND', 'LastName': 'Eliazar-Macke', 'Affiliation': 'Research Service, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Orozco', 'Affiliation': 'Research Service, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Uphold', 'Affiliation': 'Geriatric Research Education and Clinical Center, North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.'}]",Clinical rehabilitation,['10.1177/0269215520957004']
2469,32907433,"Intensive Glycemic Control for Diabetic Foot Ulcer Healing: A Multicentric, Randomized, Parallel Arm, Single-Blind, Controlled Study Protocol (INGLOBE Study).","Hyperglycemia impairs healing of diabetic foot ulcer (DFU). But there is no evidence regarding benefit of intensive glucose control for healing of DFU. We plan to conduct a randomized, parallel arm, controlled study to assess the role of intensive glycemic management in comparison to conventional glucose control for healing of DFU. Participants with neuropathic DFU (infected or uninfected) having hemoglobin A1c (HbA1c) >8% and without evidence of osteomyelitis from 7 tertiary care hospitals will be enrolled. They will undergo a 2-week run-in phase for optimization of comorbidities, ulcer debridement, and counseling regarding self-monitoring of blood glucose (SMBG). Subsequently, they will be randomized to ""intensive glycemic control"" arm defined by glycemic targets of fasting blood glucose (FBG) <130 mg/dL, postprandial BG <180 mg/dL, and HbA1c <8%, with basal-bolus insulin regimen and frequent titration of insulin to achieve glycemic targets. The ""conventional"" arm will continue on prior treatment (oral antidiabetic drugs) with no titration unless meeting rescue criteria. Ulcer area will be calculated by automated wound assessment device (WoundlyClinial app) weekly for first 4 weeks, and less frequently until the 24th week. Standard treatment for DFU, off-loading, and counseling for foot care will be provided in both arms. The primary outcome measure will be number of wounds closed at 12th and 24th weeks. A multivariate regression analysis will be performed to identify the predictors of wound healing with baseline HbA1c, diabetes duration, wound size, wound duration, and background therapies as independent variable. This study will provide the much needed guidance to set optimum glucose targets in people with DFU.",2020,Participants with neuropathic DFU (infected or uninfected) having hemoglobin A1c (HbA1c) >8% and without evidence of osteomyelitis from 7 tertiary care hospitals will be enrolled.,"['people with DFU', 'Participants with neuropathic DFU (infected or uninfected) having hemoglobin A1c (HbA1c) >8% and without evidence of osteomyelitis from 7 tertiary care hospitals will be enrolled', 'Diabetic Foot Ulcer Healing']","['Intensive Glycemic Control', 'intensive glycemic management']","['number of wounds closed at 12th and 24th weeks', 'Hyperglycemia impairs healing of diabetic foot ulcer (DFU']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0406526', 'cui_str': 'Neuropathic ulcer of foot due to diabetes mellitus'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0029443', 'cui_str': 'Osteomyelitis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]",,0.0670946,Participants with neuropathic DFU (infected or uninfected) having hemoglobin A1c (HbA1c) >8% and without evidence of osteomyelitis from 7 tertiary care hospitals will be enrolled.,"[{'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Satinath', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'IPGME&R, Kolkata, India.'}, {'ForeName': 'Jay Prakash', 'Initials': 'JP', 'LastName': 'Sahoo', 'Affiliation': 'Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Mennon', 'Affiliation': 'Amrita Institute of Medical sciences, Kochi, Kerala, India.'}, {'ForeName': 'Amritava', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Raipur, India.'}, {'ForeName': 'Sujjet', 'Initials': 'S', 'LastName': 'Jha', 'Affiliation': 'Max Hospitals, New Delhi, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Bal', 'Affiliation': 'Raheja Hospital, Mumbai, Maharashtra, India.'}]",The international journal of lower extremity wounds,['10.1177/1534734620952245']
2470,32907566,"Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator.","BACKGROUND


Navafenterol (AZD8871) is a dual-pharmacology muscarinic antagonist β 2- agonist (MABA) molecule in development for the treatment of chronic obstructive pulmonary disease (COPD). The pharmacodynamics, safety and tolerability of single doses of navafenterol were investigated in patients with moderate to severe COPD.
METHODS


This was a randomized, five-way complete cross-over study. Patients received single doses of navafenterol 400 μg, navafenterol 1800 μg and placebo (all double-blind) and indacaterol 150 μg and tiotropium 18 μg (both open-label active comparators). The primary pharmacodynamic endpoint was change from baseline in trough forced expiratory volume in 1 s (FEV 1 ) on day 2. Safety and tolerability were monitored throughout.
RESULTS


Thirty-eight patients were randomized and 28 (73.7%) completed the study. Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV 1  (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001). The changes were significantly greater with navafenterol 1800 μg vs the active comparators (least squares mean treatment difference: 0.065-0.069 L, both P < .05). The frequency of treatment-emergent adverse events was similar for placebo and the active comparators (range 34.4-37.5%), slightly higher for navafenterol 400 μg (52.9%), and lowest for navafenterol 1800 μg (22.6%).
CONCLUSIONS


Both doses of navafenterol demonstrated sustained bronchodilation over 24 h. Navafenterol was well tolerated and no safety concerns were raised.
TRIAL REGISTRY


ClinicalTrials.gov ; No.: NCT02573155 ; URL: www.clinicaltrials.gov . Registered 9th October, 2015.",2020,"Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV 1  (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001).","['Thirty-eight patients were randomized and 28 (73.7%) completed the study', 'chronic obstructive pulmonary disease (COPD', 'patients with moderate to severe COPD', 'patients with COPD']","['navafenterol', 'navafenterol 400\u2009μg, navafenterol 1800\u2009μg and placebo', 'placebo', 'indacaterol 150\u2009μg and tiotropium 18\u2009μg (both open-label active comparators', 'Navafenterol', 'Navafenterol (AZD8871']","['tolerated and no safety concerns', 'Safety and tolerability', 'trough forced expiratory volume in 1\u2009s (FEV 1 ) on day 2', 'pharmacodynamics, safety and tolerability', 'frequency of treatment-emergent adverse events']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",38.0,0.72429,"Navafenterol 400 μg and 1800 μg demonstrated statistically significant improvements vs placebo in change from baseline in trough FEV 1  (least squares mean [95% confidence interval]: 0.111 [0.059, 0.163] L and 0.210 [0.156, 0.264] L, respectively, both P < .0001).","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'The Medicines Evaluation Unit, Centre for Respiratory and Allergy Medicine, University of Manchester, University Hospital of South Manchester NHS Foundation Trust, M23 9QZ, Manchester, UK. dsingh@meu.org.uk.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Balaguer', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Astbury', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby-Hamrén', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Seoane', 'Affiliation': 'Biometrics and Information Sciences, Late-Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Villarroel', 'Affiliation': 'Late-Stage Development, BioPharmaceuticals R&D; AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Alejhandra', 'Initials': 'A', 'LastName': 'Lei', 'Affiliation': 'Patient Safety RIA, Chief Medical Office, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Respiratory research,['10.1186/s12931-020-01347-7']
2471,32907573,Evaluation of a novel intervention to reduce burnout in doctors-in-training using self-care and digital wellbeing strategies: a mixed-methods pilot.,"BACKGROUND


Burnout for doctors-in-training is increasingly cause for concern. Our objectives were to assess the feasibility, acceptability and impact of a novel intervention to reduce burnout and improve wellbeing. This is the first wellbeing intervention for medical doctors to include strategies for work-life boundary management and digital wellbeing.
METHODS


Twenty-two doctors participated in face-to-face workshops which included group discussion of challenges experienced and strategies to enhance self-care and wellbeing. A pre-post-test mixed-methods evaluation was undertaken. Questionnaire measures were the Oldenburg Burnout Inventory, Warwick-Edinburgh Mental Wellbeing Scale and the boundary control subscale of the Work-Life Indicator (i.e., the degree of perception of control of the boundaries between work and personal life). Paired t-tests examined whether there were statistically significant differences. Eleven doctors also participated in post-intervention semi-structured interviews. Transcripts were analysed using thematic analysis.
RESULTS


The intervention was well-received, with all trainees finding the workshop useful and saying they would recommend it to others. At baseline most participants had scores indicative of burnout on both the disengagement (82%) and exhaustion (82%) subscales of the Oldenburg Burnout Inventory. One month post-intervention, participants had a statistically significant reduction in burnout (both disengagement and exhaustion) and improvement in boundary control. Wellbeing scores also improved, but differences were not statistically significant. Qualitative analysis indicated participants had welcomed a safe space to discuss stressors and many had implemented digital wellbeing strategies to manage their smartphone technology, and increased self-care such as mindfulness practice and walking in green space.
CONCLUSIONS


The intervention reduced burnout and improved boundary control. We suggest that having protected time for doctors to share personal experiences, adopt digital wellbeing and self-care strategies are effective tools to support doctors' wellbeing and should be investigated further.",2020,"One month post-intervention, participants had a statistically significant reduction in burnout (both disengagement and exhaustion) and improvement in boundary control.","['Twenty-two doctors participated in face-to-face workshops which included group discussion of challenges experienced and strategies to enhance self-care and wellbeing', 'Eleven doctors also participated in post-intervention semi-structured interviews']",['novel intervention'],"['Wellbeing scores', 'boundary control', 'degree of perception of control of the boundaries between work and personal life', 'Oldenburg Burnout Inventory, Warwick-Edinburgh Mental Wellbeing Scale and the boundary control subscale of the Work-Life Indicator']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",22.0,0.0285969,"One month post-intervention, participants had a statistically significant reduction in burnout (both disengagement and exhaustion) and improvement in boundary control.","[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Rich', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Marta E', 'Initials': 'ME', 'LastName': 'Cecchinato', 'Affiliation': 'Computer and Information Sciences Department, Northumbria University, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lascau', 'Affiliation': 'UCL Interaction Centre, University College London, London, UK.'}, {'ForeName': 'Magdalen', 'Initials': 'M', 'LastName': 'Baker', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Viney', 'Affiliation': 'Research Department of Medical Education, UCL Medical School, University College London, London, UK.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Cox', 'Affiliation': 'UCL Interaction Centre, University College London, London, UK. anna.cox@ucl.ac.uk.'}]",BMC medical education,['10.1186/s12909-020-02160-y']
2472,32907575,"Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies.","BACKGROUND


Navafenterol (AZD8871) is a novel, long-acting, dual-pharmacology (muscarinic receptor antagonist and β 2- adrenoceptor agonist) molecule in development for chronic obstructive pulmonary disease and asthma.
METHODS


These two phase I, randomised, single-blind, multiple-ascending-dose studies evaluated inhaled navafenterol and placebo (3:1 ratio) in healthy, male, non-Japanese (study A; NCT02814656) and Japanese (study B; NCT03159442) volunteers. In each study, volunteers were dosed in three cohorts, allowing gradual dose escalation from 300 μg to 600 μg to 900 μg. The primary objective was to investigate the safety and tolerability of navafenterol at steady state. Pharmacokinetics were also assessed.
RESULTS


Twenty-four volunteers completed each study (navafenterol, n = 6; placebo, n = 2 in each cohort). There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol. The most frequent TEAEs were vessel puncture-site bruise (placebo, n = 2; navafenterol 900 μg; n = 3) in study A and diarrhoea (placebo, n = 1; navafenterol 300 μg, n = 2; navafenterol 900 μg, n = 3) in study B. No dose-response relationship was observed for TEAEs. There was a dose-dependent increase in mean heart rate on day 16 in both studies. The pharmacokinetics of navafenterol were similar between non-Japanese and Japanese volunteers.
CONCLUSIONS


Multiple ascending doses of navafenterol were well-tolerated and the safety and pharmacokinetics of navafenterol were similar in non-Japanese and Japanese volunteers. The findings support navafenterol clinical development.
TRIAL REGISTRATION


ClinicalTrials.gov ; Nos.: NCT02814656 and NCT03159442; URL: www.clinicaltrials.gov .",2020,"There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol.","['Twenty-four volunteers completed each study (navafenterol, n\u2009=\u20096; placebo, n\u2009=\u20092 in each cohort', '3:1 ratio) in healthy, male, non-Japanese (study A; NCT02814656) and Japanese (study B; NCT03159442) volunteers', 'healthy volunteers']","['diarrhoea (placebo, n\u2009=\u20091; navafenterol 300\u2009μg, n\u2009=\u20092; navafenterol', 'placebo', 'inhaled navafenterol and placebo', 'Navafenterol (AZD8871']","['no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol', 'safety, tolerability and pharmacokinetics', 'safety and tolerability', 'mean heart rate', 'safety and pharmacokinetics of navafenterol', 'vessel puncture-site bruise']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1535879', 'cui_str': 'Vessel puncture site bruise'}]",24.0,0.187776,"There were no deaths, serious adverse events (AEs) or treatment-emergent AEs (TEAEs) leading to discontinuation of navafenterol.","[{'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Balaguer', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'the Early Phase Clinical Unit, PAREXEL International GmbH, Harrow, UK.'}, {'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby-Hamrén', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Astbury', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Seoane', 'Affiliation': 'Biometrics and Information Sciences, Late Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Malice', 'Affiliation': 'Early Biostats and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Alejhandra', 'Initials': 'A', 'LastName': 'Lei', 'Affiliation': 'Patient Safety RIA, Chief Medical Office, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Boston, MA, USA.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK. ioannis.psallidas@astrazeneca.com.'}]",Respiratory research,['10.1186/s12931-020-01474-1']
2473,32907576,"Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator.","BACKGROUND


Navafenterol (AZD8871) is an inhaled long-acting dual-pharmacology muscarinic antagonist/β 2 -adrenoceptor agonist (MABA) in development for the treatment of obstructive airways diseases. The safety, tolerability, pharmacodynamics, and pharmacokinetics of navafenterol were investigated in patients with mild asthma.
METHODS


This was a randomised, single-blind, placebo-controlled, single-ascending-dose study. Patients were randomly assigned to one of two cohorts which evaluated escalating doses of navafenterol (50-2100 μg) in an alternating manner over three treatment periods. The primary pharmacodynamic endpoint was the change from pre-dose baseline in trough forced expiratory volume in 1 s (FEV 1 ) for each treatment period.
RESULTS


Sixteen patients were randomised; 15 completed treatment. Data from all 16 patients were analysed. The maximum tolerated dose was not identified, and all doses of navafenterol were well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were headache (n = 10, 62.5%) and nasopharyngitis (n = 7, 43.8%). No TEAEs were serious, fatal, or led to discontinuation, and no dose dependency was identified. Navafenterol demonstrated a dose-ordered bronchodilatory response with a rapid onset of action (within 5 min post-dose). Doses ≥200 μg resulted in improvements in trough FEV 1  (mean change from baseline range 0.186-0.463 L) with sustained bronchodilation for 24-36 h. Plasma concentrations increased in a dose-proportional manner, peaking ~ 1 h post-dose, with a derived terminal elimination half-life of 15.96-23.10 h.
CONCLUSIONS


In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.
TRIAL REGISTRATION


ClinicalTrials.gov; No.: NCT02573155.",2020,"In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.
TRIAL REGISTRATION


ClinicalTrials.gov;","['obstructive airways diseases', 'Sixteen patients were randomised; 15 completed treatment', 'patients with mild asthma']","['2 -adrenoceptor agonist (MABA', 'navafenterol', 'placebo', 'Navafenterol', 'Navafenterol (AZD8871']","['safety, tolerability, pharmacodynamics, and pharmacokinetics of navafenterol', 'headache', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'change from pre-dose baseline in trough forced expiratory volume in 1\u2009s (FEV 1 ', 'trough FEV 1', 'tolerated', 'Plasma concentrations', 'nasopharyngitis']","[{'cui': 'C0600260', 'cui_str': 'Obstructive airways disorder'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}]",16.0,0.284631,"In this study navafenterol was generally well tolerated with a rapid onset of action which was sustained over 36 h.
TRIAL REGISTRATION


ClinicalTrials.gov;","[{'ForeName': 'Eulalia', 'Initials': 'E', 'LastName': 'Jimenez', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, 08020, Barcelona, Spain. lali.jimenez@astrazeneca.com.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Astbury', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Early Phase Clinical Unit, PAREXEL International GmbH, Harrow, UK.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Wählby-Hamrén', 'Affiliation': 'Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Seoane', 'Affiliation': 'Biometrics and Information Sciences, Late-Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Villarroel', 'Affiliation': 'Late-Stage Development, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pujol', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Maria Jesus', 'Initials': 'MJ', 'LastName': 'Bermejo', 'Affiliation': 'Patient Safety, Chief Medical Office, R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Barcelona, Spain.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Respiratory research,['10.1186/s12931-020-01470-5']
2474,32907619,"A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial.","BACKGROUND


Undifferentiated connective tissue disease (UCTD) is known to induce adverse pregnancy outcomes and even recurrent spontaneous abortion (RSA) by placental vascular damage and inflammation activation. Anticoagulation can prevent pregnancy morbidities. However, it is unknown whether the addition of immune suppressants to anticoagulation can prevent spontaneous pregnancy loss in UCTD patients. The purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and low-dose prednisone on recurrent pregnancy loss for women with UCTD.
METHODS


The Immunosuppressant for Living Fetuses (ILIFE) Trial is a three-arm, multicenter, open-label randomized controlled trial with the primary objective of comparing hydroxychloroquine combined with low-dose prednisone and anticoagulation with anticoagulation alone in treating UCTD women with recurrent spontaneous abortion. The third arm of using hydroxychloroquine combined with anticoagulant for secondary comparison. A total of 426 eligible patients will be randomly assigned to each of the three arms with a 1:1:1 allocation ratio. The primary outcome is the rate of live births. Secondary outcomes include adverse pregnancy outcomes and progression of UCTD.
DISCUSSION


This is the first multi-center, open-label, randomized controlled trial which evaluates the efficacy of immunosuppressant regimens on pregnancy outcomes and UCTD progression. It will provide evidence on whether the immunosuppressant ameliorates the pregnancy prognosis in UCTD patients with RSA and the progression into defined connective tissue disease.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03671174 . Registered on 14 September 2018.",2020,The Immunosuppressant for Living Fetuses,"['women with undifferentiated connective tissue diseases', 'women with UCTD', 'Living Fetuses', 'LIving FEtuses (ILIFE) trial', '426 eligible patients', 'UCTD patients', 'treating UCTD women with recurrent spontaneous abortion']","['hydroxychloroquine (HCQ) and low-dose prednisone', 'hydroxychloroquine combined with anticoagulant', 'hydroxychloroquine combined with low-dose prednisone and anticoagulation with anticoagulation alone', 'hydroxychloroquine and low-dose prednisone', 'immunosuppressant regimens', 'ILIFE']","['rate of live births', 'pregnancy outcomes and UCTD progression', 'adverse pregnancy outcomes and progression of UCTD', 'recurrent pregnancy loss', 'pregnancy morbidities']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0409999', 'cui_str': 'Undifferentiated connective tissue disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0409999', 'cui_str': 'Undifferentiated connective tissue disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",426.0,0.200771,The Immunosuppressant for Living Fetuses,"[{'ForeName': 'Shaoying', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Ruoning', 'Initials': 'R', 'LastName': 'Ni', 'Affiliation': 'Department of Internal Medicine, Saint Agnes Hospital, Baltimore, MD, USA.'}, {'ForeName': 'Yikang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Suli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact (formerly Clinical Epidemiology and Biostatistics), McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China. zhangchunyan_sp@163.com.'}, {'ForeName': 'Liangjing', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Rheumatology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Middle Shandong Road, Shanghai, 200001, China. lu_liangjing@163.com.'}]",Trials,['10.1186/s13063-020-04716-1']
2475,32877582,Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis.,"BACKGROUND


Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models. The efficacy and safety of a combination of the two compounds in persons with amyotrophic lateral sclerosis (ALS) are not known.
METHODS


In this multicenter, randomized, double-blind trial, we enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months. Participants were randomly assigned in a 2:1 ratio to receive sodium phenylbutyrate-taurursodiol (3 g of sodium phenylbutyrate and 1 g of taurursodiol, administered once a day for 3 weeks and then twice a day) or placebo. The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks. Secondary outcomes were the rates of decline in isometric muscle strength, plasma phosphorylated axonal neurofilament H subunit levels, and the slow vital capacity; the time to death, tracheostomy, or permanent ventilation; and the time to death, tracheostomy, permanent ventilation, or hospitalization.
RESULTS


A total of 177 persons with ALS were screened for eligibility, and 137 were randomly assigned to receive sodium phenylbutyrate-taurursodiol (89 participants) or placebo (48 participants). In a modified intention-to-treat analysis, the mean rate of change in the ALSFRS-R score was -1.24 points per month with the active drug and -1.66 points per month with placebo (difference, 0.42 points per month; 95% confidence interval, 0.03 to 0.81; P = 0.03). Secondary outcomes did not differ significantly between the two groups. Adverse events with the active drug were mainly gastrointestinal.
CONCLUSIONS


Sodium phenylbutyrate-taurursodiol resulted in slower functional decline than placebo as measured by the ALSFRS-R score over a period of 24 weeks. Secondary outcomes were not significantly different between the two groups. Longer and larger trials are necessary to evaluate the efficacy and safety of sodium phenylbutyrate-taurursodiol in persons with ALS. (Funded by Amylyx Pharmaceuticals and others; CENTAUR ClinicalTrials.gov number, NCT03127514.).",2020,"The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks.","['Amyotrophic Lateral Sclerosis', 'persons with ALS', '177 persons with ALS were screened for eligibility, and 137', 'persons with amyotrophic lateral sclerosis (ALS', 'enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months']","['sodium phenylbutyrate-taurursodiol (3 g of sodium phenylbutyrate and 1 g of taurursodiol', 'sodium phenylbutyrate-taurursodiol', 'placebo', 'Sodium Phenylbutyrate-Taurursodiol']","['rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range', 'mean rate of change in the ALSFRS-R score', 'slower functional decline', 'efficacy and safety', 'Adverse events', 'rates of decline in isometric muscle strength, plasma phosphorylated axonal neurofilament H subunit levels, and the slow vital capacity; the time to death, tracheostomy, or permanent ventilation; and the time to death, tracheostomy, permanent ventilation, or hospitalization', 'ALSFRS-R score', 'neuronal death']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4305309', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised score'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1505576', 'cui_str': 'NEFH protein, human'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}]",177.0,0.608843,"The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks.","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Elliott', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Maiser', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Caress', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Owegi', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Heiman-Patterson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Jenkins', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Scelsa', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Fournier', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Glass', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dagostino', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Dickson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Ellison', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Hendrix', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Kittle', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ostrow', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randall', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sherman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tustison', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Prasha', 'Initials': 'P', 'LastName': 'Vigneswaran', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klee', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Rudolph E', 'Initials': 'RE', 'LastName': 'Tanzi', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilbert', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Yeramian', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}]",The New England journal of medicine,['10.1056/NEJMoa1916945']
2476,32900856,Nurse practitioner administered point-of-care ultrasound compared with X-ray for children with clinically non-angulated distal forearm fractures in the ED: a diagnostic study.,"BACKGROUND


Paediatric distal forearm fractures are a common ED presentation. They can be diagnosed with point-of-care ultrasound (POCUS) as an alternative to X-rays. Given that ED nurse practitioners (NPs) are relied on for the diagnosis of paediatric fractures, it is important to describe the diagnostic accuracy of NP-conducted POCUS versus X-ray.
METHODS


This prospective diagnostic study was conducted in a tertiary paediatric hospital in Queensland, Australia, between February 2018 and April 2019. Participants were children aged 4-16 years with a clinically non-angulated, suspected distal forearm fracture. Diagnosis from 6-view NP-administered POCUS of the distal radius and ulna was compared against the reference standard of 2-view X-ray. Each patient received both imaging modalities. Overall forearm diagnosis was classified as 'no', 'buckle' or 'other' fracture for both modalities. The primary outcome was diagnostic accuracy for 'any' fracture ('buckle' and 'other' fractures combined). Secondary outcomes included diagnostic accuracy for 'other' fractures versus 'buckle' and 'no' fractures combined, and pain, imaging duration and preference for modality.
RESULTS


Of 204 recruited patients, 129 had X-ray-diagnosed forearm fractures. The sensitivity and specificity for NP-administered POCUS were 94.6% (95% CI 89.2% to 97.3%) and 85.3% (95% CI 75.6% to 91.6%), respectively. 'Other' fractures (mostly cortical breach fractures), when compared with 'buckle'/ 'no' fractures, had sensitivity 81.0% (95% CI 69.1% to 89.1%) and specificity 95.9% (95% CI 91.3% to 98.1%). Pain and imaging duration were clinically similar between modalities. There was a preference for POCUS by patients, parents and NPs.
CONCLUSIONS


NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries. This included good sensitivity for diagnosis of 'any' fracture and good specificity for diagnosis of cortical breach fractures alone. Given the preference for POCUS, and the lack of difference in pain and duration between modalities, future research should consider functional outcomes comparing POCUS with X-ray in this population in a randomised controlled trial.",2020,"CONCLUSIONS


NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries.","['children with clinically non-angulated distal forearm fractures in the ED', '204 recruited patients, 129 had X-ray-diagnosed forearm fractures', 'Participants were children aged 4-16 years with a clinically non-angulated, suspected distal forearm fracture', 'paediatric patients presenting with non-angulated distal forearm injuries', 'tertiary paediatric hospital in Queensland, Australia, between February 2018 and April 2019']","['Nurse practitioner administered point-of-care ultrasound compared with X-ray', 'NP-administered POCUS']","['Overall forearm diagnosis', 'Pain and imaging duration', 'diagnostic accuracy', ""diagnostic accuracy for 'other' fractures versus 'buckle' and 'no' fractures combined, and pain, imaging duration and preference for modality"", ""diagnostic accuracy for 'any' fracture ('buckle' and 'other' fractures combined"", 'sensitivity and specificity for NP-administered POCUS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1305215', 'cui_str': 'Fracture of forearm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0016537', 'cui_str': 'Injury of forearm'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",204.0,0.0717416,"CONCLUSIONS


NP-administered POCUS had clinically acceptable diagnostic accuracy for paediatric patients presenting with non-angulated distal forearm injuries.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snelling', 'Affiliation': 'School of Medicine, Griffith University Faculty of Health, Southport, Queensland, Australia peter.snelling@health.qld.gov.au.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Jones', 'Affiliation': ""Emergency and Trauma Centre, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Keijzers', 'Affiliation': 'Department of Emergency Medicine, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bade', 'Affiliation': ""Department of Orthopaedics, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Herd', 'Affiliation': ""Department of Emergency Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-209689']
2477,32900916,Clinical Outcomes of Male Subjects With Moderate COPD Based on Maximum Mid-Expiratory Flow.,"BACKGROUND


Although FEV 1  and FEV 1 /FVC are accepted as standard parameters in treatment follow-up, these parameters have a limited ability to predict clinical outcomes in patients with COPD. However, small airways dysfunction, which is determined by maximum mid-expiratory flow, is variable in the same stage of patients with COPD, even if their FEV 1  and FEV 1 /FVC are similar. The aim of this study was to compare pulmonary function, the severity of perceived dyspnea, the severity of fatigue, physical activity level, and health-related quality of life based on the severity of small airways dysfunction in male subjects with moderate COPD.
METHODS


The study consisted of 96 subjects with moderate COPD. Pulmonary function tests, the distance achieved on the 6-min walk test, the modified Medical Research Council Dyspnea Scale, the International Physical Activity Questionnaire - short form, the Fatigue Severity Scale, the St George Respiratory Questionnaire, and Short Form 36 questionnaire were evaluated in all subjects. After calculating the mean percent of predicted maximum mid-expiratory flow for the entire sample, subjects were divided into 2 groups: below average (Group 1,  n  = 54 subjects) and above average (Group 2,  n  = 42 subjects).
RESULTS


There were no differences between the groups in age, body mass index, cigarette consumption, percent of predicted FEV 1 , and FEV 1 /FVC ( P  = .55, .61, .19, .09, and .15, respectively). Scores from the Fatigue Severity Scale and the modified Medical Research Council dyspnea scale were significantly higher in Group 1 ( P  = .003 and  P  = .002, respectively); in addition, results from the 6-min walk test and the International Physical Activity Questionnaire - short form scores were significantly lower ( P  = .001 and  P  < .001, respectively).
CONCLUSIONS


Increased small airways dysfunction led to increased perception of dyspnea and fatigue, as well as poor exercise capacity and health-related quality of life in male subjects with COPD. We suggest that it may be useful to consider the maximum mid-expiratory flow in addition to FEV 1  and FEV 1 /FVC in the treatment and follow-up of male patients with moderate COPD.",2020,"Scores from the Fatigue Severity Scale and the modified Medical Research Council dyspnea scale were significantly higher in Group 1 ( P  = .003 and  P  = .002, respectively); in addition, results from the 6-min walk test and the International Physical Activity Questionnaire - short form scores were significantly lower (","['male subjects with moderate COPD', 'Male Subjects With Moderate COPD Based on Maximum Mid-Expiratory Flow', 'male patients with moderate COPD', 'male subjects with COPD', 'patients with COPD', '96 subjects with moderate COPD']",[],"['pulmonary function, the severity of perceived dyspnea, the severity of fatigue, physical activity level, and health-related quality of life', 'distance achieved on the 6-min walk test, the modified Medical Research Council Dyspnea Scale, the International Physical Activity Questionnaire - short form, the Fatigue Severity Scale, the St George Respiratory Questionnaire, and Short Form 36 questionnaire', '6-min walk test and the International Physical Activity Questionnaire - short form scores', 'Fatigue Severity Scale and the modified Medical Research Council dyspnea scale']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0269306,"Scores from the Fatigue Severity Scale and the modified Medical Research Council dyspnea scale were significantly higher in Group 1 ( P  = .003 and  P  = .002, respectively); in addition, results from the 6-min walk test and the International Physical Activity Questionnaire - short form scores were significantly lower (","[{'ForeName': 'Ridvan', 'Initials': 'R', 'LastName': 'Aktan', 'Affiliation': 'Department of Physiotherapy, Vocational School of Health Services, Izmir University of Economics, Izmir, Turkey. ridvanaktan@gmail.com.'}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Ozalevli', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylül University, Izmir, Turkey.'}, {'ForeName': 'Aylin Ozgen', 'Initials': 'AO', 'LastName': 'Alpaydin', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Dokuz Eylül University, Izmir, Turkey.'}]",Respiratory care,['10.4187/respcare.07794']
2478,32901072,"Standardized massage interventions as protocols for the induction of psychophysiological relaxation in the laboratory: a block randomized, controlled trial.","Health and disease are strongly linked to psychophysiological states. While stress research strongly benefits from standardized stressors, no established protocol focuses on the induction of psychophysiological relaxation. To maintain health, functioning regenerative systems are however likely as important as functioning stress systems. Thus, the identification of validated relaxation paradigms is needed. Here, we investigated whether standardized massages are capable of reliably inducing physiological and psychological states of relaxation. Relaxation was indicated by changes in high frequency heart rate variability (HF-HRV), a vagally-mediated heart rate variability component, and repeated ratings of subjective relaxation, and stress levels. Sixty healthy women were randomly assigned to a vagus nerve massage (n = 19), a soft shoulder massage (n = 22), or a resting control group (n = 19). During the intervention, HF-HRV and subjective relaxation increased, while subjective stress decreased significantly in all groups. Both massage interventions elicited significantly higher HF-HRV compared to the control group. Accordingly, both massage protocols increased psychophysiological relaxation, and may serve as useful tools in future research. However, future work will have to determine which of several protocols might be used as a gold standard to induce a psychophysiological state of relaxation in the laboratory.",2020,"During the intervention, HF-HRV and subjective relaxation increased, while subjective stress decreased significantly in all groups.",['Sixty healthy women'],"['soft shoulder massage', 'Standardized massage interventions', 'vagus nerve massage']","['HF-HRV and subjective relaxation', 'subjective stress', 'psychophysiological relaxation', 'HF-HRV', 'high frequency heart rate variability (HF-HRV), a vagally-mediated heart rate variability component, and repeated ratings of subjective relaxation, and stress levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042276', 'cui_str': 'Vagus nerve structure'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",60.0,0.0207587,"During the intervention, HF-HRV and subjective relaxation increased, while subjective stress decreased significantly in all groups.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany. maria.meier@uni.kn.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Unternaehrer', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Dimitroff', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Annika B E', 'Initials': 'ABE', 'LastName': 'Benz', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Ulrike U', 'Initials': 'UU', 'LastName': 'Bentele', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Sabine M', 'Initials': 'SM', 'LastName': 'Schorpp', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Wenzel', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Department of Psychology, Division of Clinical Neuropsychology, University of Constance, Constance, Germany.'}]",Scientific reports,['10.1038/s41598-020-71173-w']
2479,32901199,Does learning a skill with the expectation of teaching it impair the skill's execution under psychological pressure if the skill is learned with analogy instructions?,"Objective


Having learners practice a motor skill with the expectation of teaching it (versus an expectation of being tested on it) has been revealed to enhance skill learning. However, this improvement in skill performance is lost when the skill must be performed under psychological pressure due to 'choking under pressure.' The present study will investigate whether this choking effect is caused by an accrual of declarative knowledge during skill practice and could be prevented if a technique (analogy instructions) to minimize the accrual of declarative knowledge during practice is employed.
Design


We will use a 2 (Expectation: teach/test) x 2 (Instruction: analogy/explicit) x 2 (Posttest: high-pressure/low-pressure) mixed-factor design, with repeated measures on the last factor.
Methods


A minimum of 148 participants will be quasi-randomly assigned (based on sex) to one of four groups. Participants in the teach/analogy and teach/explicit groups will practice golf putting with the expectation of teaching putting to another participant, and analogy instructions or explicit instructions, respectively. Participants in the test/analogy and test/explicit groups will practice golf putting with the expectation of being tested on their putting, and analogy instructions or explicit instructions, respectively. The next day all participants will complete low- and high-pressure putting posttests, with their putting accuracy serving as the dependent variable.",2020,"However, this improvement in skill performance is lost when the skill must be performed under psychological pressure due to 'choking under pressure.'",['148 participants will be quasi-randomly assigned (based on sex) to one of four groups'],[],['skill performance'],"[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],[],148.0,0.0272957,"However, this improvement in skill performance is lost when the skill must be performed under psychological pressure due to 'choking under pressure.'","[{'ForeName': 'Daniel A R', 'Initials': 'DAR', 'LastName': 'Cabral', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Daou', 'Affiliation': 'Department of Kinesiology, Coastal Carolina University, Williams-Brice 111, P.O. Box 261954, Conway, SC, 29528, USA.'}, {'ForeName': 'Mariane F B', 'Initials': 'MFB', 'LastName': 'Bacelar', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}, {'ForeName': 'Juliana O', 'Initials': 'JO', 'LastName': 'Parma', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Miller', 'Affiliation': 'School of Kinesiology, Auburn University, 301 Wire Road, Kinesiology Building, Auburn, AL, 36849, USA.'}]",Psychology of sport and exercise,['10.1016/j.psychsport.2020.101757']
2480,32901234,Improving oral health: a short-term split-mouth randomized clinical trial revealing the superiority of resin infiltration over remineralization of white spot lesions.,"OBJECTIVES


To evaluate masking effects of resin infiltration on labial white spot lesions (WSL), by comparing the latter with a remineralization approach (using hydroxyapatite and fluorides) and conventional oral care (using fluoride-free toothpaste).
METHOD AND MATERIALS


Fifteen patients with at least three WSL were enrolled for a within-person randomized controlled trial, thus allowing for intrapersonal comparisons. Each WSL per tooth in every patient was randomly assigned to one of the following groups. Group 1: lesions were resin-infiltrated with Icon (RI; DMG); Group 2: Remin Pro (RP; VOCO) was used as remineralizing agent; and Group 3 (control): affected teeth were brushed with Complete Care toothpaste (CC; Himalaya). RP and CC were applied by means of a polishing brush, using a low-speed handpiece (5 min), and these procedures were repeated chairside thrice daily for 7 consecutive days. Digital photographs were captured before and after lesion treatment under standardized conditions. The CIE L*a*b* color system was used to analyze the optical outcome, and intrapersonal color differences were statistically evaluated.
RESULTS


Compared to RP and CC, RI showed prompt and subjectively satisfactory color improvements, and this was primarily driven by L* and b* shifts. Statistical analysis of the objective color differences (ΔE*) between the three groups revealed significant differences for RI vs RP (P = .029), RI vs CC (P < .001), and RP vs CC (P = .001).
CONCLUSION


Resin infiltration is considered a time-effective treatment option for esthetically camouflaging WSL, while RP and CC failed to improve lesion appearance and oral health in the current short-term trial.",2020,"Statistical analysis of the objective color differences (ΔE*) between the three groups revealed significant differences for RI vs RP (P = .029), RI vs CC (P < .001), and RP vs CC (P = .001).
","['white spot lesions', 'Fifteen patients with at least three WSL']","['resin infiltration', 'remineralizing agent; and Group 3 (control): affected teeth were brushed with Complete Care toothpaste (CC; Himalaya', 'remineralization approach (using hydroxyapatite and fluorides) and conventional oral care (using fluoride-free toothpaste', 'resin-infiltrated with Icon (RI; DMG); Group 2: Remin Pro (RP; VOCO']",['lesion appearance and oral health'],"[{'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0033382', 'cui_str': 'Proline'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",15.0,0.0389163,"Statistical analysis of the objective color differences (ΔE*) between the three groups revealed significant differences for RI vs RP (P = .029), RI vs CC (P < .001), and RP vs CC (P = .001).
","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Youssef', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Farid', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Zayed', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lynch', 'Affiliation': ''}, {'ForeName': 'Mohammad K', 'Initials': 'MK', 'LastName': 'Alam', 'Affiliation': ''}, {'ForeName': 'Andrej M', 'Initials': 'AM', 'LastName': 'Kielbassa', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a45104']
2481,32907824,Tailoring anticoagulant treatment of patients with atrial fibrillation using a novel bleeding risk score.,"OBJECTIVES


Current international guidelines advocate the application of bleeding risk scores only to identify modifiable risk factors, but not to withhold treatment in patients at high risk of bleeding. VTE-BLEED (ActiVe cancer, male with uncontrolled hyperTension, anaEmia, history of BLeeding, agE and rEnal Dysfunction) is a simple bleeding risk score that predicts major bleeding (MB) in patients with venous thromboembolism, but has never been evaluated in patients with atrial fibrillation (AF). We sought to evaluate VTE-BLEED in patients with AF included in the Randomised Evaluation of Long-term anticoagulant therapY (RE-LY) trial, to assess whether score classes (high vs low bleeding risk) interact with the tested dabigatran doses (150 vs 110 mg twice daily), and to investigate whether dose reductions based on this interaction might help to lower the incidence of the composite outcome MB, stroke/systemic embolism or death.
METHODS


The score was calculated in the safety population of RE-LY (n=18 040) and recalibrated for AF (AF-adapted VTE-BLEED or AF-BLEED). HRs were calculated to evaluate the score's predictive accuracy for MB. The risk ratios (RRs) for the composite outcome comparing dabigatran 150 and 110 mg twice daily were calculated for the high-risk group.
RESULTS


AF-BLEED classified 3534 patients (19.6%) at high bleeding risk, characterised by a 2.9-fold to 3.4-fold higher risk of bleeding than low bleeding risk patients, across the treatment arms. High bleeding risk patients randomised to 110 mg twice daily had a lower incidence of the composite outcome than those randomised to 150 mg twice daily, for an RR of 0.52 (95% CI 0.35 to 0.78). Compared with the label criteria for dose reduction, AF-BLEED identified an additional 11% of patients who might have benefited from dose reduction.
CONCLUSIONS


AF-BLEED identified patients with AF at high risk of bleeding. Our findings raise the hypothesis that dabigatran 110 mg twice daily might be considered in patients classified as high risk according to the AF-BLEED score. This study provides a basis for future studies to explore safe dose reductions of direct oral anticoagulants in selected patient groups based on bleeding scores.",2020,"High bleeding risk patients randomised to 110 mg twice daily had a lower incidence of the composite outcome than those randomised to 150 mg twice daily, for an RR of 0.52","['patients at high risk of bleeding', 'patients with AF', 'patients with atrial fibrillation (AF', 'patients with venous thromboembolism', 'patients with atrial fibrillation using a novel bleeding risk score']","['Long-term anticoagulant therapY (RE-LY', 'VTE-BLEED']","['risk ratios (RRs', 'bleeding scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039184', 'cui_str': 'High risk of bleeding'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0382101,"High bleeding risk patients randomised to 110 mg twice daily had a lower incidence of the composite outcome than those randomised to 150 mg twice daily, for an RR of 0.52","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chu', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands k.g.chu@lumc.nl.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Valerio', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), Johannes Gutenberg University University Medical Center, Mainz, Germany.'}, {'ForeName': 'Sake J', 'Initials': 'SJ', 'LastName': 'van der Wall', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), Johannes Gutenberg University University Medical Center, Mainz, Germany.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Konstantinides', 'Affiliation': 'Center for Thrombosis and Hemostasis (CTH), Johannes Gutenberg University University Medical Center, Mainz, Germany.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Frederikus A', 'Initials': 'FA', 'LastName': 'Klok', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.'}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-316305']
2482,32907828,"Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial.","OBJECTIVE


To assess the efficacy and feasibility of a dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation compared with an insulin-only closed-loop system and a predictive low glucose suspend (PLGS) system.
RESEARCH DESIGN AND METHODS


In a 76-h, randomized, crossover, outpatient study, 23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system:  1 ) dual-hormone (DH) closed-loop control,  2 ) insulin-only single-hormone (SH) closed-loop control, and  3 ) PLGS system. The primary end point was percentage time in hypoglycemia (<70 mg/dL) from the start of in-clinic aerobic exercise (45 min at 60% VO 2max ) to 4 h after.
RESULTS


DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5],  P  = 0.025). There was an increased time in hyperglycemia (>180 mg/dL) during and after exercise for DH versus SH (20.8% DH vs. 6.3% SH,  P  = 0.038). Mean glucose during the entire study duration was DH, 159.2; SH, 151.6; and PLGS, 163.6 mg/dL. Across the entire study duration, DH resulted in 7.5% more time in target range (70-180 mg/dL) compared with the PLGS system (71.0% vs. 63.4%,  P  = 0.044). For the entire study duration, DH had 28.2% time in hyperglycemia vs. 25.1% for SH ( P  = 0.044) and 34.7% for PLGS ( P  = 0.140). Four participants experienced nausea related to glucagon, leading three to withdraw from the study.
CONCLUSIONS


The glucagon formulation demonstrated feasibility in a closed-loop system. The DH system reduced hypoglycemia during and after exercise, with some increase in hyperglycemia.",2020,"RESULTS


DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5],  P  = 0.025).",['23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system:  1 '],"['Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System', 'dual-hormone (DH) closed-loop control,  2 ) insulin-only single-hormone (SH) closed-loop control, and  3 ) PLGS system', 'glucagon', 'dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation']","['Mean glucose', 'hyperglycemia', 'hypoglycemia', 'time in hyperglycemia', 'nausea', 'percentage time in hypoglycemia']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0336563', 'cui_str': 'Artificial pancreas'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0860801', 'cui_str': 'Glucose low'}, {'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",23.0,0.0307921,"RESULTS


DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5],  P  = 0.025).","[{'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Wilson', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR wilsolea@ohsu.edu.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Ramsey', 'Affiliation': 'Oregon Clinical and Translational Research Institute Biostatistics and Design Program, Oregon Health & Science University & Portland State University School of Public Health, Portland, OR.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Resalat', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Reddy', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Branigan', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Leitschuh', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Gabo', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guillot', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Senf', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'El Youssef', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Isabelle Isa Kristin', 'Initials': 'IIK', 'LastName': 'Steineck', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Nichole S', 'Initials': 'NS', 'LastName': 'Tyler', 'Affiliation': 'Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR.'}]",Diabetes care,['10.2337/dc19-2267']
2483,32907896,Strategies adopted by men to deal with uncertainty and anxiety when following an active surveillance/monitoring protocol for localised prostate cancer and implications for care: a longitudinal qualitative study embedded within the ProtecT trial.,"OBJECTIVES


Active surveillance (AS) enables men with low risk, localised prostate cancer (PCa) to avoid radical treatment unless progression occurs; lack of reliable AS protocols to determine progression leaves uncertainties for men and clinicians. This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.
DESIGN


Longitudinal serial in-depth qualitative interviews every 2-3 years for a median 7 (range 6-14) years following diagnosis.
SETTING


Four centres within the UK Protect trial.
PARTICIPANTS


Purposive sample of 20 men with localised PCa: median age at diagnosis 64 years (range 52-68); 15 (75%) had low-risk PCa; 12 randomly allocated to, 8 choosing AM. Eleven men continued with AM throughout the study period (median 7 years). Nine received radical treatment after a median 4 years (range 0.8-13.8 years).
INTERVENTION


AM: 3-monthly serum prostate-specific antigen (PSA)-level assessment (year 1), 6-12 monthly thereafter; increase in PSA ≥50% during previous 12 months or patient/clinician concern triggered review.
MAIN OUTCOMES


Thematic analysis of 73 interviews identified strategies to accommodate uncertainty and anxiety of living with untreated cancer; implications for patient care.
RESULTS


Men sought clarity, control or reassurance, with contextual factors mediating individual responses. Trust in the clinical team was critical for men in balancing anxiety and facilitating successful management change/continued monitoring. Only men from ProtecT were included; men outside ProtecT may have different experiences.
CONCLUSION


Men looked to clinicians for clarity, control and reassurance. Where provided, men felt comfortable continuing AM or having radical treatments when indicated. Clinicians build patient trust by clearly describing uncertainties, allowing patients control wherever possible and being aware of how context influences individual responses. Insights indicate need for supportive services to build trust and patient engagement over the long term.
TRIAL REGISTRATION NUMBER


ISRCTN20141297; Pre-results.",2020,"This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.
","['Purposive sample of 20 men with localised PCa: median age at diagnosis 64 years (range 52-68); 15 (75%) had low-risk PCa; 12 randomly allocated to, 8 choosing AM', 'Four centres within the UK Protect trial', 'Eleven men continued with AM throughout the study period (median 7 years', 'men with low risk, localised prostate cancer (PCa', 'Only men from ProtecT were included; men outside ProtecT may have different experiences']",['radical treatment'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1828181', 'cui_str': 'Age at diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],20.0,0.0392427,"This study investigated men's strategies for coping with the uncertainties of active monitoring (AM, a surveillance strategy within the Prostate testing for cancer and Treatment, ProtecT trial) over the longer term and implications for optimising supportive care.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Wade', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK julia.wade@bristol.ac.uk.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Athene', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Walsh', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Turner', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Martin', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Peters', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Freddie', 'Initials': 'F', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield Medical School, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Rosario', 'Affiliation': 'Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology, NHS Lothian, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Faculty of Medicine, Health and Human Science, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Gnanapragasam', 'Affiliation': 'Department of Surgery, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036024']
2484,32907900,Preferences of people with type 2 diabetes for telemedical lifestyle programmes in Germany: protocol of a discrete choice experiment.,"INTRODUCTION


Telemedical lifestyle programmes for people with type 2 diabetes mellitus (T2DM) provide an opportunity to develop a healthier lifestyle and consequently to improve health outcomes. When implementing new programmes into standard care, considering patients' preferences may increase the success of the participants. This study aims to examine the preferences of people with T2DM with respect to telemedical lifestyle programmes, to analyse whether these preferences predict programme success and to explore the changes that may occur during a telemedical lifestyle intervention.
METHODS AND ANALYSIS


We outline the protocol of the development and assessment of a discrete choice experiment (DCE) to examine patient preferences in a telemedical lifestyle programme with regard to the functions of the online portal, communication, responsibilities, group activities and time requirements. To develop the design of the DCE, we conducted pilot work involving healthcare experts and in particular people with T2DM using cognitive pretesting. The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c  values in 850 members of a large German statutory health insurance with T2DM. Preferences are being assessed before and after participants complete the programme. The DCE data will be analysed using regression and latent class analyses.
ETHICS AND DISSEMINATION


The DCE study has been approved by the ethics committee of the medical faculty of the Heinrich Heine University Duesseldorf, registration number 2018-242-ProspDEuA, registered on 6 December 2018. The TeLIPro trial is registered at the US National Library of Medicine, registration number NCT03675919, registered on 15 September 2018. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.",2020,The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c  values in 850 members of a large German statutory health insurance with T2DM.,"['people with type 2 diabetes for telemedical lifestyle programmes in Germany', 'particular people with T2DM using cognitive pretesting', '850 members of a large German statutory health insurance with T2DM', 'people with type 2 diabetes mellitus (T2DM']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]",[],[],,0.0670766,The final DCE is being implemented within a randomised controlled trial for investigating whether participation in a telemedical lifestyle intervention programme sustainably improves the HbA 1c  values in 850 members of a large German statutory health insurance with T2DM.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany jana.sommer@uni-duesseldorf.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dyczmons', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Grobosch', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Gontscharuk', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vomhof', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research (DZD), Neuherberg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, German Diabetes Center (DDZ), Leibniz Center for Diabetes Research at the Heinrich Heine University, Duesseldorf, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-036995']
2485,32908192,Infant gut microbiota characteristics generally do not modify effects of lipid-based nutrient supplementation on growth or inflammation: secondary analysis of a randomized controlled trial in Malawi.,"An unhealthy gut microbial community may act as a barrier to improvement in growth and health outcomes in response to nutritional interventions. The objective of this analysis was to determine whether the infant microbiota modified the effects of a randomized controlled trial of lipid-based nutrient supplements (LNS) in Malawi on growth and inflammation at 12 and 18 months, respectively. We characterized baseline microbiota composition of fecal samples at 6 months of age (n = 506, prior to infant supplementation, which extended to 18 months) using 16S rRNA gene sequencing of the V4 region. Features of the gut microbiota previously identified as being involved in fatty acid or micronutrient metabolism or in outcomes relating to growth and inflammation, especially in children, were investigated. Prior to correction for multiple hypothesis testing, the effects of LNS on growth appeared to be modified by Clostridium (p-for-interaction = 0.02), Ruminococcus (p-for-interaction = 0.007), and Firmicutes (p-for-interaction = 0.04) and effects on inflammation appeared to be modified by Faecalibacterium (p-for-interaction = 0.03) and Streptococcus (p-for-interaction = 0.004). However, after correction for multiple hypothesis testing these findings were not statistically significant, suggesting that the gut microbiota did not alter the effect of LNS on infant growth and inflammation in this cohort.",2020,An unhealthy gut microbial community may act as a barrier to improvement in growth and health outcomes in response to nutritional interventions.,"['fecal samples at 6\xa0months of age (n\u2009=\u2009506, prior to infant supplementation, which extended to 18\xa0months) using 16S rRNA gene sequencing of the V4 region']","['lipid-based nutrient supplements (LNS', 'lipid-based nutrient supplementation', 'LNS']",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0035899', 'cui_str': 'Ribosomal RNA Genes'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]",[],,0.124015,An unhealthy gut microbial community may act as a barrier to improvement in growth and health outcomes in response to nutritional interventions.,"[{'ForeName': 'Riley L', 'Initials': 'RL', 'LastName': 'Hughes', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Young', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'College of Medicine, University of Malawi, Blantyre 3, Malawi.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Fan', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ulla', 'Initials': 'U', 'LastName': 'Ashorn', 'Affiliation': 'Center for Child Health Research, Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaima', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Chikondi', 'Initials': 'C', 'LastName': 'Malamba-Banda', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Kable', 'Affiliation': 'Immunity and Disease Prevention, Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA. kgdewey@ucdavis.edu.'}]",Scientific reports,['10.1038/s41598-020-71922-x']
2486,32908246,First CRISPR editing trial results assuage safety concerns.,,2019,,[],[],[],[],[],[],,0.0169466,,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Reardon', 'Affiliation': ''}]",Nature medicine,['10.1038/d41591-019-00019-4']
2487,32908282,Insulin dose optimization using an automated artificial intelligence-based decision support system in youths with type 1 diabetes.,"Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals 1 . This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n = 54) or by physicians (physician arm, n = 54). The results for the primary efficacy measure-the percentage of time spent within the target glucose range (70-180 mg dl -1  (3.9-10.0 mmol l -1 ))-in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P < 1 × 10 -7 ). The percentage of readings below 54 mg dl -1  (<3.0 mmol l -1 ) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 ± 1.4% versus 1.0 ± 0.9%, respectively, P < 0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.",2020,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","['youths with type 1 diabetes', '108 participants with type 1 diabetes, aged 10-21 years and using insulin pump therapy (ClinicalTrials.gov no']","['Insulin dose optimization using an automated artificial intelligence-based decision support system', 'remote insulin dose adjustment every three weeks guided by either an AI-DSS', 'frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS']","['percentage of time spent within the target glucose range', 'severe hypoglycemia, one diabetic ketoacidosis']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}]",108.0,0.0687685,"In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers.","[{'ForeName': 'Revital', 'Initials': 'R', 'LastName': 'Nimri', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}, {'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, One Joslin Place, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Slover', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Schatz', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Weinzimer', 'Affiliation': 'Pediatric Endocrinology & Diabetes, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Klemen', 'Initials': 'K', 'LastName': 'Dovc', 'Affiliation': ""Department of Endocrinology, Diabetes and Metabolic Diseases, UMC-University Children's Hospital Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents, Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. mosheph@tauex.tau.ac.il.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature medicine,['10.1038/s41591-020-1045-7']
2488,32908355,Strategic Initiatives for Veterans with Lung Cancer.,"Background


Lung cancer is a leading cause of cancer-related mortality among veterans-as well as the US population-despite veterans' access to advanced medical technologies within the Veterans Health Administration (VHA). To improve outcomes, the VHA launched 3 lung cancer treatment initiatives in 2016 and 2017.
Observations


This article summarizes the VHA lung cancer initiatives and discusses future programs aimed to improve care for veterans. The US Department of Veterans Affairs (VA) Partnership to Increase Access to Lung Screening aims to reduce lung cancer mortality among veterans at risk by increasing access to low-dose computed tomography lung screening scans. The VALOR study is a randomized phase 3 clinical trial that evaluates optimal treatment for participants with operable early stage non-small cell lung cancer (NSCLC). This trial plans to enroll veterans with stage I NSCLC who will be randomly assigned to treatment with either surgical lobectomy or stereotactic body radiation therapy. Researchers will follow each participant for at least 5 years to evaluate which treatment, if either, results in a higher overall survival rate. The VA Radiation Oncology Quality Surveillance program compares treatment of veterans with lung cancer in the VHA with quality standards recommended by nationally recognized experts in lung cancer care.
Conclusions


The VHA continues to prioritize resources to improve and assure optimal outcomes for veterans with lung cancer. Future efforts include creating a national network of lung cancer centers of excellence to ensure that treatment decisions for veterans with lung cancer are based on all available molecular information, including data on pharmacogenomic profiles.",2020,"Researchers will follow each participant for at least 5 years to evaluate which treatment, if either, results in a higher overall survival rate.","['veterans with lung cancer', 'Veterans with Lung Cancer', 'participants with operable early stage non-small cell lung cancer (NSCLC', 'enroll veterans with stage']",['surgical lobectomy or stereotactic body radiation therapy'],"['overall survival rate', 'lung cancer mortality']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0215884,"Researchers will follow each participant for at least 5 years to evaluate which treatment, if either, results in a higher overall survival rate.","[{'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Moghanaki', 'Affiliation': 'is Section Chief of Radiation Oncology at the Atlanta VA Health Care System in Georgia. is Director of the Veterans Health Administration National Radiation Oncology Program in Richmond, Virginia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hagan', 'Affiliation': 'is Section Chief of Radiation Oncology at the Atlanta VA Health Care System in Georgia. is Director of the Veterans Health Administration National Radiation Oncology Program in Richmond, Virginia.'}]","Federal practitioner : for the health care professionals of the VA, DoD, and PHS",['10.12788/fp.0019']
2489,32908559,Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial.,"Damage to intramuscular tendons is very common in sports injuries, specifically in soleus muscle injuries. This study sought to compare the effects of applying ultrasound- (US-) guided percutaneous needle electrolysis (PNE) in combination with an eccentric exercise program on pain and functionality in dancers with chronic soleus injury, located in the central tendon. Thirty dancers with injured central tendon of the soleus muscle were randomly allocated to a PNE group ( n  = 10), an eccentric exercise group ( n  = 10), or a combined group ( n  = 10). Pain, ankle dorsiflexion range of motion (DROM), endurance, the heel raise test, the DFOS questionnaire, and the minimal clinically important difference (MCID) were analyzed at baseline and after treatment (four weeks). Over half (52%) of the dancers had a chronic soleus muscle injury. Variables for pain, DROM, the heel rise test, ADL, technique, DFOS total, and DFOS-subjective variables showed significant differences ( P  < 0.05) in pretreatment and posttreatment in all groups, whereas no significant differences were observed between intervention groups. However, the combined group showed a higher percentage of changes compared to the other groups, and these dancers had greater perceived changes (MCID = 4.70 ± 1.42). The conclusion of the study was that dancers with chronic soleus injury, located in the central tendon, treated with a combination of US-guided PNE and an eccentric exercise program displayed improved outcomes compared to the application of PNE therapy or eccentric exercise alone. The US-guided PNE, combined with an eccentric exercise program, is a useful therapeutic tool for the treatment of chronic soleus injury, located in the central tendon. The trial is registered with NCT04042012.",2020,"Pain, ankle dorsiflexion range of motion (DROM), endurance, the heel raise test, the DFOS questionnaire, and the minimal clinically important difference (MCID) were analyzed at baseline and after treatment (four weeks).","['Thirty dancers with injured central tendon of the soleus muscle', 'dancers with chronic soleus injury, located in the central tendon', 'Dancers with Chronic Soleus Injury']","['eccentric exercise program', 'PNE', 'eccentric exercise group', 'Ultrasound-Guided Percutaneous Needle Electrolysis', 'ultrasound- (US-) guided percutaneous needle electrolysis (PNE', 'PNE therapy or eccentric exercise alone']","['pain, DROM, the heel rise test, ADL, technique, DFOS total, and DFOS-subjective variables', 'Pain, ankle dorsiflexion range of motion (DROM), endurance, the heel raise test, the DFOS questionnaire, and the minimal clinically important difference (MCID', 'pain and functionality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0230162', 'cui_str': 'Central tendon of diaphragm structure'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0332285', 'cui_str': 'In'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}]",30.0,0.0301061,"Pain, ankle dorsiflexion range of motion (DROM), endurance, the heel raise test, the DFOS questionnaire, and the minimal clinically important difference (MCID) were analyzed at baseline and after treatment (four weeks).","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street 41009, Seville, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, Avicena Street 41009, Seville, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Valera-Garrido', 'Affiliation': 'MVClinic Institute, Madrid, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Minaya-Muñoz', 'Affiliation': 'MVClinic Institute, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Villaviciosa de Odón, Madrid, Spain.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/4156258']
2490,32908567,Oral and Topical  Centella asiatica  in Type 2 Diabetes Mellitus Patients with Dry Skin: A Three-Arm Prospective Randomized Double-Blind Controlled Trial.,"Introduction


Uncontrolled diabetes mellitus (DM) is related to skin disorders, particularly dry skin. Pathogenesis of dry skin in type 2 diabetes mellitus (T2DM) rises from the chronic hyperglycemia causing an increase in  advanced glycation end-products  (AGEs), proinflammatory cytokines, and oxidative stress. Combination of oral and topical  Centella asiatica  (CA) is expected to treat dry skin in T2DM patients more effectively through decreasing N(6)-carboxymethyl-lysine (CML) and interleukin-1 α  (IL-1 α ) and increasing superoxide dismutase (SOD) activity.
Methods


A three-arm prospective, double-blind, randomized, controlled study was performed to evaluate the efficacy of the oral and topical CA extract in 159 T2DM patients with dry skin. The subjects were divided into the CA oral (CAo) 2 × 1.100 mg + CA topical (CAt) 1% ointment group, oral placebo (Plo) + CAt group, and Plo and topical placebo (Plt) group. Dry skin assessment was performed on day 1, 15, and 29, while evaluation of CML, IL-1 α , and SOD activity was on day 1 and 29.
Result


Effectivity of CAo + CAt combination was assessed based on HbA1c and random blood glucose (RBG). In well-controlled blood glucose, on day 29, the percentage of SRRC decrement was greater in the CAo + CAt group compared to the control group ( p  = 0.04). SCap value in the CAo + CAt group was greater than that in the control group ( p  = 0.01). In the partially controlled blood glucose, increment of SOD activity in the CAo + CAt group was greater than that in the control group ( p  = 0.01). There were medium-to-strong correlation between CML with SOD ( r  = 0.58,  p  < 0.05) and IL-1 α  with SOD ( r  = 0.70,  p  < 0.05) in well-controlled blood glucose. Systemic and topical adverse events were not significantly different between groups.
Conclusion


CAo and CAt combination can be used to significantly improve dry skin condition through increasing SOD activity in T2DM patients with controlled blood glucose.",2020,SCap value in the CAo + CAt group was greater than that in the control group ( p  = 0.01).,"['T2DM patients with controlled blood glucose', 'Type 2 Diabetes Mellitus Patients with Dry Skin', '159 T2DM patients with dry skin']","['Oral and Topical  Centella asiatica', 'CA oral (CAo) 2', 'oral and topical CA extract', 'CAo\u2009+\u2009CAt combination', 'mg\u2009+\u2009CA topical (CAt', 'oral placebo (Plo)\u2009+\u2009CAt group, and Plo and topical placebo (Plt', 'oral and topical  Centella asiatica  (CA']","['Dry skin assessment', 'SCap value', 'HbA1c and random blood glucose (RBG', 'CML, IL-1 α , and SOD activity', 'SOD activity', 'N(6)-carboxymethyl-lysine (CML) and interleukin-1 α  (IL-1 α ) and increasing superoxide dismutase (SOD) activity', 'Systemic and topical adverse events', 'percentage of SRRC decrement', 'IL-1 α  with SOD']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0772382', 'cui_str': 'Gotu kola'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0201617', 'cui_str': 'Primed lymphocyte test'}]","[{'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428567', 'cui_str': 'Random blood glucose measurement'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4508788', 'cui_str': 'carboxymethyllysine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",159.0,0.0493053,SCap value in the CAo + CAt group was greater than that in the control group ( p  = 0.01).,"[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Legiawati', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Kusmarinah', 'Initials': 'K', 'LastName': 'Bramono', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Wresti', 'Initials': 'W', 'LastName': 'Indriatmi', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Em', 'Initials': 'E', 'LastName': 'Yunir', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Setiati', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Sri Widia A', 'Initials': 'SWA', 'LastName': 'Jusman', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Erni H', 'Initials': 'EH', 'LastName': 'Purwaningsih', 'Affiliation': 'Department of Medical Pharmacy, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Heri', 'Initials': 'H', 'LastName': 'Wibowo', 'Affiliation': 'Integrated Laboratorium, Faculty of Medicine, Universitas Indonesia, Jakarta 10430, Indonesia.'}, {'ForeName': 'Retno', 'Initials': 'R', 'LastName': 'Danarti', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/7253560']
2491,32908648,Evaluation of titanium-prepared platelet-rich fibrin and leucocyte platelet-rich fibrin in the treatment of intra-bony defects: A randomized clinical trial.,"Background.  Various treatment modalities, such as leucocyte platelet-rich fibrin (L-PRF), bone grafts, and membranes, have been used for the restoration of lost periodontal tissues. Titanium-prepared platelet-rich fibrin (T-PRF) has attracted attention for its proper haemocompatibility, thick fibrin meshwork, and long resorption time. The present study aimed to evaluate the effectiveness of T-PRF and L-PRF in the management of intra-bony defects based on clinical and radiographic criteria.  Methods.  Twenty-six subjects with 34 intra-bony 3- walled defects were divided into two groups (n=17) and treated with T-PRF or L-PRF. Clinical and radiographic measurements were recorded at baseline and 6- , 3- and 9- month intervals and tabulated on Microsoft Excel spreadsheets. For intra- and intergroup comparisons, paired and unpaired t-tests were performed. P<0.05 was set as statistically significant  Results.  Intra-group comparisons revealed statistically significant differences (P<0.05) from baseline in both groups regarding clinical measurements. On intergroup comparison, the T-PRF group exhibited a significantly higher defect fill compared to the L-PRF group (P<0.05).  Conclusion.  Within the limits of the present study, T-PRF seems to be a better alternative to L-PRF in the treatment of intra-bony defects.",2020,Intra-group comparisons revealed statistically significant differences (P<0.05) from baseline in both groups regarding clinical measurements.,"['Twenty-six subjects with 34 intra-bony 3- walled defects', 'intra-bony defects']","['Titanium-prepared platelet-rich fibrin (T-PRF', 'T-PRF and L-PRF', 'T-PRF or L-PRF', 'titanium-prepared platelet-rich fibrin and leucocyte platelet-rich fibrin']",['Clinical and radiographic measurements'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0033374', 'cui_str': 'Prolactin releasing factor'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",26.0,0.0396981,Intra-group comparisons revealed statistically significant differences (P<0.05) from baseline in both groups regarding clinical measurements.,"[{'ForeName': 'Shiva Shankar', 'Initials': 'SS', 'LastName': 'Gummaluri', 'Affiliation': 'Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'Hirak S', 'Initials': 'HS', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Oral Pathology and Microbiology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'Madhusudan', 'Initials': 'M', 'LastName': 'Astekar', 'Affiliation': 'Department of Oral Pathology and Microbiology, Institute of Dental Sciences, Bareilly, Uttar Pradesh, India.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Cheruvu', 'Affiliation': 'Department of Periodontology and Implantology, SIBAR Institute of Dental Sciences, Guntur, Andhra Pradesh, India.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.020']
2492,32908651,Comparison of the effect of bleaching with 15% carbamide peroxide and 35% hydrogen peroxide on flexural strength of Cention N in selfcured and dual-cured polymerization modes.,"Background.  The use of bleaching agents might result in microstructural changes in tooth structure and in restorative materials. This study compared the effects of bleaching with %15 carbamide peroxide and %35 hydrogen peroxide on the flexural strength of Cention N restorative material using the self-cured and dual-cured polymerization modes.  Methods.  Sixty bar-shaped samples of Cention N restorative material were included in this in vitro study and assigned to three groups (n=20) randomly: control, bleaching with %15 carbamide peroxide and bleaching with %35 hydrogen peroxide. Each group was divided into two subgroups: samples polymerized in the self-cured mode and samples polymerized in the dual-cured mode. Then the flexurals trengths of the samples were determined. Two-way ANOVA was used to compare flexural strengths between the three groups in two polymerization modes, followed by post hoc Tukey test. Statisticals ignificance was defined at P<0.05.  Results.  The difference in the mean flexural strength was significant in terms of the bleaching regimen (P<0.001), with significantly lower flexural strength in the two bleaching groups compared to the control group. However, the mean flexural strengths were not significantly different in terms of the polymerization mode applied (P=0.14).  Conclusion.  The application of %15 carbamide peroxide and %35 hydrogen peroxide bleaching agents decreased the flexural strength of Cention N restorative material. Irrespective of the bleaching regimen, there was no significant difference in the flexural strength of Cention N between the self-curing and dual-curing polymerization modes.",2020,The application of %15 carbamide peroxide and %35 hydrogen peroxide bleaching agents decreased the flexural strength of Cention N restorative material.,['Sixty bar-shaped samples of Cention N restorative material were included in this in vitro study and assigned to three groups (n=20) randomly'],"['bleaching agents', 'control, bleaching with %15 carbamide peroxide and bleaching with %35 hydrogen peroxide', '15 carbamide peroxide and %35 hydrogen peroxide bleaching agents', 'bleaching with 15% carbamide peroxide and 35% hydrogen peroxide', 'bleaching with %15 carbamide peroxide and %35 hydrogen peroxide']","['flexural strength', 'flexural strength of Cention N', 'mean flexural strength', 'flexural strength of Cention N restorative material', 'mean flexural strengths', 'flexural strengths']","[{'cui': 'C0993613', 'cui_str': 'Bar'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2936259', 'cui_str': 'Whitening Agents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]","[{'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}]",,0.0115989,The application of %15 carbamide peroxide and %35 hydrogen peroxide bleaching agents decreased the flexural strength of Cention N restorative material.,"[{'ForeName': 'Narmin', 'Initials': 'N', 'LastName': 'Mohammadi', 'Affiliation': 'Dental and Periodontal Research Center, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Kimyai', 'Affiliation': 'Dental and Periodontal Research Center, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yasaman', 'Initials': 'Y', 'LastName': 'Ghavami Lahij', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Bahari', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Amir Ahmad', 'Initials': 'AA', 'LastName': 'Ajami', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Abed Kahnamouei', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Daneshpooy', 'Affiliation': 'Department of Operative Dentistry, Faculty of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.023']
2493,32908653,Root dentin surface activation to improve bioceramic bonding: A scanning electron microscopic study.,"Background.  Bioceramics need to interact chemically with dentin to exhibit adequate bioactivity. Proper bonding of bioceramics with dentin is of considerable importance. This study aimed to evaluate the wettability and marginal adaptation of bioceramics after the use of surface-active agents on dentin: %0.5 cetrimide and %1 alkylbenzene sulfonate.  Methods.  Of ninety maxillary central incisors, 45 teeth were sectioned longitudinally with 45 root halves randomly assigned to three groups (n=15): group I: no pre-treatment; group II: %0.5 cetrimide; group III: %1 alkylbenzene sulfonate. Then, the samples were subdivided into three subgroups (n=5): subgroup I: MTA; subgroup II: Biodentine, and subgroup III: BioRoot. A controlled-volume droplet of bioceramic material was placed on each root half, which was positioned in a dynamic contact angle analyzer to record the static contact angle for wettability. The remaining 45 samples were decoronated; the root canals were prepared and randomly categorized, as mentioned above. The root canal surfaces were treated, filled with the bioceramic material, transversely sectioned, and then each middle section was analyzed microscopically for marginal adaptation. Statistical tests used included post hoc Tukey tests and one-way ANOVA. The level of statistical significance set at %95 (P<0.05).  Results.  The contact angle values and interfacial gap width values after surface pre-treatment were significantly lower when compared to no pre-treatment group (P<0.05). The values were significant for %0.5 cetrimide in the case of Biodentine and %1 alkylbenzene sulfonate in the case of BioRoot (P<0.05).  Conclusion.  The two surfactants yielded promising results for enhancing the wettability and marginal adaptation of materials to the root dentin, which is required for obtaining an adequate seal, penetration, and bond strength of bioceramics.",2020,The contact angle values and interfacial gap width values after surface pre-treatment were significantly lower when compared to no pre-treatment group (P<0.05).,"['Of ninety maxillary central incisors, 45 teeth were sectioned longitudinally with 45 root halves randomly assigned to three groups (n=15', 'bioceramic bonding']","['alkylbenzene sulfonate', 'Biodentine, and subgroup III: BioRoot']","['wettability and marginal adaptation of bioceramics', 'contact angle values and interfacial gap width values']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002072', 'cui_str': 'Alkyl Sulfonates'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0162598', 'cui_str': 'Wetability'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",45.0,0.0188076,The contact angle values and interfacial gap width values after surface pre-treatment were significantly lower when compared to no pre-treatment group (P<0.05).,"[{'ForeName': 'Shazeena', 'Initials': 'S', 'LastName': 'Qaiser', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences.'}, {'ForeName': 'Mithra N', 'Initials': 'MN', 'LastName': 'Hegde', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences.'}, {'ForeName': 'Darshana', 'Initials': 'D', 'LastName': 'Devadiga', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences.'}, {'ForeName': 'Mahalaxmi', 'Initials': 'M', 'LastName': 'Yelapure', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, A B Shetty Memorial Institute of Dental Sciences.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.025']
2494,32908656,Extraction socket preservation using a collagen plug combined with platelet-rich plasma (PRP): A comparative clinico-radiographic study.,"Background.  Alveolar bone remodeling after tooth loss results in reduced ridge dimensions in horizontal and vertical planes. To prevent this, various authors have proposed different ridge preservation techniques. A collagen plug is a novel material that has shown promising results in preserving the alveolar bone. PRP has also yielded favorable outcomes in wound healing and promoted osteoinduction and osteoconduction  Methods.  Thirty patients of both sexes with an age range of 30-18 years requiring bilateral extraction of teeth with similar tooth root anatomy in the maxilla or mandible were included in the study. The extraction of teeth was carried out atraumatically. The patients' arches were randomly divided and labeled as the test or control sides. Bone width was measured on both sides. A collagen plug, with PRP, was placed, and the extraction socket was sutured on the test side. The control side was just sutured. A baseline RVG was taken to record the apico-coronal height. The patients were recalled after 10 days for suture removal and evaluation of wound healing. Parameters were re-evaluated at three and six months postoperatively. The data were subjected to t-test and one-way ANOVA.  Results.  The height of the crestal bone on the grafted side was more when compared to the non-grafted side three and six months after tooth extractions, and the difference was statically significant (P<0.001). No statistically significant difference was seen in the width of the alveolar bone three and six months after tooth extraction (P>0.05).  Conclusion.  Collagen and PRP provided reasonable socket preservation as simple and inexpensive options as compared to other materials.",2020,No statistically significant difference was seen in the width of the alveolar bone three and six months after tooth extraction (P>0.05).  ,['Thirty patients of both sexes with an age range of 30-18 years requiring bilateral extraction of teeth with similar tooth root anatomy in the maxilla or mandible were included in the study'],"['PRP', 'collagen plug combined with platelet-rich plasma (PRP', 'Collagen and PRP']","['Bone width', 'width of the alveolar bone', 'suture removal and evaluation of wound healing', 'height of the crestal bone on the grafted side']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0184936', 'cui_str': 'Removal of suture'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]",30.0,0.0191973,No statistically significant difference was seen in the width of the alveolar bone three and six months after tooth extraction (P>0.05).  ,"[{'ForeName': 'Numaan', 'Initials': 'N', 'LastName': 'Nisar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Institute of Medical Sciences, Karad, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Nilesh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Institute of Medical Sciences, Karad, India.'}, {'ForeName': 'Mushtaq Ishaq', 'Initials': 'MI', 'LastName': 'Parkar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Institute of Medical Sciences, Karad, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Punde', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Dental Sciences, Krishna Institute of Medical Sciences, Karad, India.'}]","Journal of dental research, dental clinics, dental prospects",['10.34172/joddd.2020.028']
2495,32908679,Outcomes of Idiopathic Full-Thickness Macular Hole Surgery: Comparing Two Different ILM Peeling Sizes.,"Purpose


This study aimed to show the impact of different extents of internal limiting membrane (ILM) peeling on visual and anatomical outcomes following idiopathic full-thickness macular hole (FTMH) surgery.
Methods


In this single-center prospective study, patients with idiopathic FTMH underwent standard pars plana vitrectomy with two different extents of ILM peeling: 2-disc diameters (DD) or 4 DD. The main outcome measures were the closure rate of the holes based on optical coherence tomography (OCT) findings at three months after surgery.
Results


Forty eyes from 39 patients were enrolled in the study. After three months, anatomical closure was achieved in 78% and 76% eyes in 2 DD peel and 4 DD peel groups, respectively. From 29 eyes with macular hole index (MHI) ≤ 0.5, type 1 closure was achieved in 42% eyes receiving a 2 DD ILM peel, compared to 66% eyes receiving a 4 DD peel ( p =0.041). In comparison, this significant difference was not seen in the subgroup of MHI > 0.5 ( p =061). In the subgroup of subjects with baseline MHI ≤ 0.5, visual improvement was significantly more in eyes with 4 DD ILM peeling ( p =0.034), which was not seen in the MHI > 0.5 subgroup ( p =0.61).
Conclusion


In patients with idiopathic full-thickness macular hole (MHI ≤ 0.5), a larger ILM peel of 4 DD appears to yield better anatomical outcomes than a more limited 2 DD peel.",2020,"From 29 eyes with macular hole index (MHI) ≤ 0.5, type 1 closure was achieved in 42% eyes receiving a 2 DD ILM peel, compared to 66% eyes receiving a 4 DD peel ( p =0.041).","['idiopathic full-thickness macular hole (FTMH) surgery', 'patients with idiopathic FTMH underwent', 'patients with idiopathic full-thickness macular hole (MHI\u2009≤\u20090.5', 'Results\n\n\nForty eyes from 39 patients were enrolled in the study']","['internal limiting membrane (ILM) peeling', 'standard pars plana vitrectomy with two different extents of ILM peeling: 2-disc diameters (DD) or 4 DD', 'Idiopathic Full-Thickness Macular Hole Surgery']","['visual improvement', 'anatomical closure', 'closure rate of the holes based on optical coherence tomography (OCT) findings']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C1275949', 'cui_str': 'Disc diameter'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C2733564', 'cui_str': 'Full thickness hole of macula lutea'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",39.0,0.077224,"From 29 eyes with macular hole index (MHI) ≤ 0.5, type 1 closure was achieved in 42% eyes receiving a 2 DD ILM peel, compared to 66% eyes receiving a 4 DD peel ( p =0.041).","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Khodabande', 'Affiliation': 'Retina Service, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mahmoudi', 'Affiliation': 'Retina Service, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hooshang', 'Initials': 'H', 'LastName': 'Faghihi', 'Affiliation': 'Retina Service, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Bazvand', 'Affiliation': 'Retina Service, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Ebrahimi', 'Affiliation': 'Retina Service, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Riazi-Esfahani', 'Affiliation': 'Retina Service, Farabi Eye Hospital, Tehran University of Medical Science, Tehran, Iran.'}]",Journal of ophthalmology,['10.1155/2020/1619450']
2496,32908694,"Effects of Nutrition Education on Improving Knowledge and Practice of Complementary Feeding of Mothers with 6- to 23-Month-Old Children in Daycare Centers in Hawassa Town, Southern Ethiopia: An Institution-Based Randomized Control Trial.","Undernutrition and hidden hunger threaten the survival, growth, and development of children, young people, economies, and nations. Inappropriate complementary feeding practice due to poor maternal knowledge and awareness in combination with low income and infectious disease is the contributing factor for child undernutrition. Hence, this study was aimed at determining the effect of nutrition education on improving the knowledge and practice of complementary feeding of the mothers with 6- to 23-month old children in daycare centers of Hawassa Town, Southern Ethiopia. An institution-based randomized control trial design was employed. Daycare centers were randomly allocated for the intervention group and the control group. Among the total daycare centers in the town, five were assigned to receive nutrition education and the rest five for the control group (CG). The simple random sampling technique used to select individual participants from each daycare center. Two hundred (200) mother-child pairs (100 for each group) were recruited. Sociodemographic and economic variables were collected by the structured questionnaire. Knowledge of appropriate complementary feeding was assessed by seven knowledge questions. Appropriate complementary feeding practice was assessed by adapting Alive and Thrive Infant and Young Child Feeding (IYCF) practice guidelines. Nutrition education was given for four consecutive months by using Alive and Thrive IYCF guidelines. Data were analyzed by the SPSS software program version 20. The chi-squared test was used to test the significant differences in the proportion of good knowledge and good practice of complementary feeding and good dietary diversity between two groups. The independent  t  test was used to test the significant differences in mean dietary diversity between two groups. At 95% confidence interval,  p  < 0.05 was considered statistically significant. The results revealed that the proportion of mothers with good knowledge of appropriate complementary feeding was increased from 59% at pretest to 96% at posttest and the appropriate complementary feeding practice was improved from 54% at pretest to 86% at posttest in IG. There was no change in the knowledge and practice of complementary feeding practice in CG after four months. The proportion of mothers with good complementary knowledge was 54% both at pretest and at posttest and good complementary feeding practice was 51% and 52% at pre- and posttest in CG, respectively. There was no significant difference ( p  > 0.05) on complementary feeding knowledge and practice between two groups at pretest, while the difference was highly significant ( p  < 0.05) at the posttest. In conclusion, providing nutrition education improved the appropriate complementary feeding knowledge and practice of mothers. In recommendation, government and other partners working on sustainable child nutrition reduction should focus on the nutrition education to improve the knowledge and appropriate complementary feeding practice including daycare centers.",2020,"There was no significant difference ( p  > 0.05) on complementary feeding knowledge and practice between two groups at pretest, while the difference was highly significant ( p  < 0.05) at the posttest.","['mothers with 6- to 23-month old children in daycare centers of Hawassa Town, Southern Ethiopia', 'Daycare centers', 'Mothers with', 'Southern Ethiopia', '6- to 23-Month-Old Children in Daycare Centers in Hawassa Town', 'Two hundred (200) mother-child pairs (100 for each group) were recruited']","['nutrition education', 'Nutrition Education']","['mean dietary diversity', 'proportion of mothers with good knowledge of appropriate complementary feeding', 'proportion of mothers with good complementary knowledge']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}]",,0.0177088,"There was no significant difference ( p  > 0.05) on complementary feeding knowledge and practice between two groups at pretest, while the difference was highly significant ( p  < 0.05) at the posttest.","[{'ForeName': 'Selam Deksiyous', 'Initials': 'SD', 'LastName': 'Muluye', 'Affiliation': 'School of Nutrition, Food Science and Technology, Hawassa University, Hawassa, Ethiopia.'}, {'ForeName': 'Tefera Belachew', 'Initials': 'TB', 'LastName': 'Lemma', 'Affiliation': 'College of Public Health and Medical Sciences, Jimma University, Jimma, Ethiopia.'}, {'ForeName': 'Tona Zema', 'Initials': 'TZ', 'LastName': 'Diddana', 'Affiliation': 'School of Nutrition, Food Science and Technology, Hawassa University, Hawassa, Ethiopia.'}]",Journal of nutrition and metabolism,['10.1155/2020/6571583']
2497,32908698,The Effect of Hand Reflexology Massage on Pain and Fatigue in Patients after Coronary Angiography: A Randomized Controlled Clinical Trial.,"Introduction


Coronary angiography can cause pain and fatigue in patients. Hand reflexology as complementary and integrative care approach has been suggested to help with the reduction of patient's pain and fatigue.
Aim


This study aimed to investigate the effect of hand reflexology on pain and fatigue in patients after coronary angiography.
Design


A randomized controlled clinical trial.
Methods


This study was conducted on 90 patients in an angiography department of a referral hospital in an urban area of Iran. The patients were randomly divided into two interventions ( n  = 45) and control ( n  = 45) groups. Hand reflexology was performed for 20 minutes in the intervention group. Pain and fatigue in the groups were measured immediately, 4 and 6 hours after the intervention.
Results


Statistically significant differences were observed in pain and fatigue scores between the groups after the intervention ( P  = 0.001). The intervention had medium to large effects on the patients' pain and fatigue. Hand reflexology as a nonpharmacological and safe technique can be used by nurses along with other pharmacologic interventions in order to reduce patients' suffering related to invasive procedures. The trial is registered with IRCT20110912007529N17.",2020,Statistically significant differences were observed in pain and fatigue scores between the groups after the intervention ( P  = 0.001).,"['90 patients in an angiography department of a referral hospital in an urban area of Iran', 'Patients after Coronary Angiography', 'patients', 'patients after coronary angiography']","['Hand Reflexology Massage', 'hand reflexology']","['Pain and Fatigue', 'Pain and fatigue', 'pain and fatigue scores', 'pain and fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0363261,Statistically significant differences were observed in pain and fatigue scores between the groups after the intervention ( P  = 0.001).,"[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Rejeh', 'Affiliation': 'Department of Nursing, Faculty of Nursing and Midwifery, Shahed University, Tehran, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Tadrisi', 'Affiliation': 'Trauma Research Center, Faculty of Nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahrooz', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': 'Cardiovascular Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Kiarash', 'Initials': 'K', 'LastName': 'Saatchi', 'Affiliation': 'Iranian Scientific Acupuncture Association, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, 8049 Bodø, Norway.'}]",Nursing research and practice,['10.1155/2020/8386167']
2498,32908702,"Corrigendum to ""Effects of Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy: A Randomized Controlled Trial"".",[This corrects the article DOI: 10.1155/2018/5496408.].,2020,[This corrects the article DOI: 10.1155/2018/5496408.].,[],['Number of Repetitions and Number of Hours of Shaping Practice during Constraint-Induced Movement Therapy'],[],[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}]",[],,0.0977632,[This corrects the article DOI: 10.1155/2018/5496408.].,"[{'ForeName': 'Auwal', 'Initials': 'A', 'LastName': 'Abdullahi', 'Affiliation': 'Department of Physiotherapy, Bayero University Kano, Kano, Kano State, Nigeria.'}]",Neurology research international,['10.1155/2020/1256231']
2499,32909059,"Effects of acute aerobic, resistance and combined exercises on 24-h glucose variability and skeletal muscle signalling responses in type 1 diabetics.","PURPOSE


To compare the effect of high-intensity aerobic (AER), resistance (RES), and combined (COMB: RES + AER) exercise, on interstitial glucose (IG) variability and skeletal muscle signalling pathways in type 1 diabetes (T1D).
METHODS


T1D participants (6 M/6F) wore a flash glucose monitoring system in four randomized sessions: one control (CONT), and one AER, RES and COMB (40 min each). Mean amplitude of glycemic excursions (MAGE), standard deviation (SD) and coefficient variation (CV) of IG were used to compare the 24 h post-exercise IG variability. Blood and muscle samples were collected to compare exercise-induced systemic and muscle signalling responses related to metabolic, growth and inflammatory adaptations.
RESULTS


Both RES and COMB decreased the 24 h MAGE compared to CONT; additionally, COMB decreased the 24 h SD and CV. In the 6-12 h post-exercise, all exercise modalities reduced the IG CV while SD decreased only after COMB. Both AER and COMB stimulated the PGC-1α mRNA expression and promoted the splicing of IGF-1Ea variant, while Akt and p38MAPK phosphorylation increased only after RES and COMB. Additionally, COMB enhanced eEF2 activation and RES increased myogenin and MRF4 mRNA expression. Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs increased after all exercise sessions, while serum CK and LDH level did not change.
CONCLUSION


COMB is more effective in reducing IG fluctuations compared to single-mode AER or RES exercise. Moreover, COMB simultaneously activates muscle signalling pathways involved in substrate metabolism and anabolic adaptations, which can help to improve glycaemic control and maintain muscle health in T1D.",2020,"Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs increased after all exercise sessions, while serum CK and LDH level did not change.
","['T1D participants (6\xa0M/6F) wore a', 'type 1 diabetes (T1D', 'type 1 diabetics']","['flash glucose monitoring system in four randomized sessions: one control (CONT), and one AER, RES and COMB', 'acute aerobic, resistance and combined exercises', 'high-intensity aerobic (AER), resistance (RES), and combined (COMB: RES\u2009+\u2009AER) exercise']","['serum CK and LDH level', 'splicing of IGF-1Ea variant, while Akt and p38MAPK phosphorylation', 'COMB', '24-h glucose variability and skeletal muscle signalling responses', 'Mean amplitude of glycemic excursions (MAGE), standard deviation (SD) and coefficient variation (CV) of IG', 'IG fluctuations', 'Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs', 'COMB enhanced eEF2 activation and RES increased myogenin and MRF4 mRNA expression']","[{'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0035687', 'cui_str': 'RNA splicing'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0164786', 'cui_str': 'c-akt Proto-Oncogene Protein'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0067053', 'cui_str': 'Myogenin'}, {'cui': 'C0083504', 'cui_str': 'myogenic factor 6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.0321494,"Blood lactate and glycerol levels and muscle IL-6, TNF-α, and MCP-1 mRNAs increased after all exercise sessions, while serum CK and LDH level did not change.
","[{'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Minnock', 'Affiliation': 'Institute for Sport and Health, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland. dean.minnock@ucdconnect.ie.'}, {'ForeName': 'Giosuè', 'Initials': 'G', 'LastName': 'Annibalini', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Carel W', 'Initials': 'CW', 'LastName': 'Le Roux', 'Affiliation': 'Diabetes Complications Research Centre, Conway Institute, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Contarelli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Laboratory of Inflammation, Metabolism, and Exercise Research (LAPIMEX) and Laboratory of Cellular Physiology, Department of Physiology, Institute of Basic Health Sciences, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Saltarelli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Valli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Vilberto', 'Initials': 'V', 'LastName': 'Stocchi', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Vito', 'Affiliation': 'Institute for Sport and Health, School of Public Health, Physiotherapy and Sports Science, University College Dublin, Belfield, Dublin 4, Ireland.'}]",European journal of applied physiology,['10.1007/s00421-020-04491-6']
2500,32909076,"A phase 2a randomised, double-blind, placebo-controlled, parallel-group, add-on clinical trial of ebselen (SPI-1005) as a novel treatment for mania or hypomania.","RATIONALE


Lithium is an effective prophylactic and anti-manic treatment in bipolar disorder; however, its use is declining through perceived poor tolerance and toxicity. Lithium inhibits inositol monophosphatase (IMPase), a probable key therapeutic mechanism. The anti-inflammatory drug, ebselen, also inhibits IMPase and appears well-tolerated and safe.
OBJECTIVES


To assess the efficacy of adjunctive ebselen in mania using the Young Mania Rating Scale (YMRS) (primary outcome) and the Altman Self-Rating Mania (ASRM) Scale and Clinical Global Impression-Severity Scale (CGI-S) among the secondary outcomes.
METHODS


Randomised, double-blind, placebo-controlled, parallel-group trial conducted between October 2017 and June 2019, at Oxford Health NHS Foundation Trust. Pharmacy-controlled randomisation was computer-generated, with full allocation concealment. In/outpatients (n = 68) aged 18-70, experiencing mania or hypomania, were assigned to 3 weeks ebselen (600 mg bd) (n = 33) or placebo (n = 35). Participants received usual clinical care and psychotropic medication.
RESULTS


Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29). However, scores on the CGI-S were significantly lower at week 3 in ebselen-treated participants (adjusted mean difference, - 0.58 (- 1.14 to - 0.03), p = 0.04). A post hoc analysis excluding patients taking concomitant valproate treatment magnified the difference between ebselen and placebo on the YMRS. Adverse events were comparable between groups, and mild.
CONCLUSIONS


Ebselen merits further investigation where concomitant psychotropic medication is better controlled and participants taking valproate are excluded. If effective, ebselen's superior tolerance and safety could make it a useful alternative to lithium.
TRIAL REGISTRATION


Trial Registry: www.clinicaltrials.gov , Identifier: NCT03013400.",2020,"RESULTS


Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29).","['October 2017 and June 2019, at Oxford Health NHS Foundation Trust', 'In/outpatients (n\u2009=\u200968) aged 18-70, experiencing mania or hypomania', 'bipolar disorder']","['Lithium inhibits inositol monophosphatase (IMPase', 'placebo', 'usual clinical care and psychotropic medication']","['YMRS', 'ASRM', 'Adverse events', 'Altman Self-Rating Mania (ASRM) Scale and Clinical Global Impression-Severity Scale (CGI-S', 'CGI-S', 'Young Mania Rating Scale (YMRS']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0163342', 'cui_str': '1L-myo-Inositol-1-phosphatase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.324514,"RESULTS


Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29).","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Sharpley', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Adele A', 'Initials': 'AA', 'LastName': 'Holder', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Beata R', 'Initials': 'BR', 'LastName': 'Godlewska', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Milensu', 'Initials': 'M', 'LastName': 'Shanyinde', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'MacDonald', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK. phil.cowen@psych.ox.ac.uk.'}]",Psychopharmacology,['10.1007/s00213-020-05654-1']
2501,32909190,Does the Time of Starting Progesterone Luteal Support Affect Embryo Transfer in Long Agonist Protocol Downregulated ICSI Cycles? A Randomized Controlled Trial.,"The aim of this study was to compare the effects of starting progesterone (P4) luteal support (LS) on day of egg retrieval (ER) or day of embryo transfer (ET) on the ratio of difficult ET and cycle outcome. This was a RCT ( ClinicalTrials.gov Identifier: NCT03040830) carried out at Mansoura Integrated Fertility Center (MIFC), Mansoura, Egypt, from November 2015 to January 2017. A total of 171 eligible long agonist ICSI cases were randomly allocated on day of ER into group A (86) starting LS as daily IM 100 mg P4 on day of ER and group B (85) starting P4-LS on day of ET. Difficult ET was defined as blood on ET catheter and/or sounding or dilating the cervix. Primary outcome was the overall ratio of difficult ET and ratios on day 3 and 5 ET. Secondary outcome was the ongoing pregnancy rate (OPR) and implantation rate (IR). The results are presented as % for groups A and B respectively: overall difficult ET (44.1, 24.7) (p = 0.009); day 3 difficult ET (23.2, 24.4) (p = 0.45); day 5 difficult ET (62.7, 25.6) (p = 0.001); overall OPR (38.3, 44.7) (p = 0.43); day 3 ET OPR (41.8, 33.3) (p = 0.51); day 5 ET OPR (34.8, 57.5) (p = 0.048); overall IR (20.0, 22.5) (p = 0.62); day 3 ET IR (17.8, 13.4) (p = 0.44); day 5 ET IR (22, 34.1) (p = 0.09). In conclusion, starting P4 luteal support on egg retrieval day is associated with significantly higher ratio of difficult embryo transfer and lower ongoing pregnancy rate and tendency to lower IR in day 5 ET, so starting P4-LS on day of ET is recommended.",2020,"In conclusion, starting P4 luteal support on egg retrieval day is associated with significantly higher ratio of difficult embryo transfer and lower ongoing pregnancy rate and tendency to lower IR in day 5 ET, so starting P4-LS on day of ET is recommended.","['Mansoura Integrated Fertility Center (MIFC), Mansoura, Egypt, from November 2015 to January 2017', 'A total of 171 eligible long agonist ICSI cases']","['starting progesterone (P4) luteal support (LS', 'egg retrieval (ER) or day of embryo transfer (ET']","['overall ratio of difficult ET and ratios on day 3 and 5 ET', 'overall IR', 'ongoing pregnancy rate (OPR) and implantation rate (IR', 'overall OPR']","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",171.0,0.0590583,"In conclusion, starting P4 luteal support on egg retrieval day is associated with significantly higher ratio of difficult embryo transfer and lower ongoing pregnancy rate and tendency to lower IR in day 5 ET, so starting P4-LS on day of ET is recommended.","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Ghanem', 'Affiliation': 'Mansoura Integrated Fertility Centre (MIFC), Mansoura, Egypt.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Bedairy', 'Affiliation': 'Mansoura Integrated Fertility Centre (MIFC), Mansoura, Egypt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shaaban', 'Affiliation': 'Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim A', 'Initials': 'IA', 'LastName': 'Albahlol', 'Affiliation': 'Mansoura Integrated Fertility Centre (MIFC), Mansoura, Egypt. ibahimelbahlool@yahoo.com.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00309-0']
2502,32909200,Clear colonoscopy as a surveillance tool in the prediction and reduction of advanced neoplasms: a randomized controlled trial.,"BACKGROUND


Missed and incompletely resected lesions remain the main cause of the recurrence of advanced neoplasms (ANs) in post-polypectomy patients. This study aims to determine whether the recurrence of ANs can be predicted and reduced by the newly developed clear colonoscopy procedure.
METHODS


Between 2006 and 2010, a total of 1350 participants with colorectal neoplasm were equally randomized to clear colonoscopy surveillance (CCS) and routine colonoscopy surveillance (RCS) in our center. Clear colonoscopy was achieved through repeat colonoscopy. On surveillance colonoscopy at 3 (for high-risk patients) and 5 (for low-risk patients) years, the recurrence of ANs and the relationship between the frequency of repeat examinations required for a clear colonoscopy and the recurrence of ANs were analyzed.
RESULTS


Surveillance colonoscopy at 3 and 5 years showed that the incidence of ANs in patients belonging to the CCS group was 1.7%, which was lower than 4.7% in patients belonging to the RCS group (P = 0.012) for both high- and low-risk patients. Out of the 1126 patients who achieved clear colonoscopy on first repeat examination, only 5 ( 0.4%) were found to have ANs on surveillance examination, whereas 12 out of the 217 (5.4%) patients on second repeat examination and 5 out of the 29 (17.2%) patients on third repeat examination were found to have ANs (P < 0.001).
CONCLUSION


Surveillance based on clear colonoscopy decreased the incidence of ANs in post-polypectomy patients. The number of repeat examinations required for a clear colonoscopy is an important factor in the prediction of the recurrence of ANs.",2020,"RESULTS


Surveillance colonoscopy at 3 and 5 years showed that the incidence of ANs in patients belonging to the CCS group was 1.7%, which was lower than 4.7% in patients belonging to the RCS group (P = 0.012) for both high- and low-risk patients.","['Between 2006 and 2010, a total of 1350 participants with colorectal neoplasm', 'advanced neoplasms']","['CCS', 'RCS', 'clear colonoscopy surveillance (CCS) and routine colonoscopy surveillance (RCS', 'Clear colonoscopy']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517567', 'cui_str': '1350'}, {'cui': 'C0009404', 'cui_str': 'Neoplasm of large intestine'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}]",[],1350.0,0.0556523,"RESULTS


Surveillance colonoscopy at 3 and 5 years showed that the incidence of ANs in patients belonging to the CCS group was 1.7%, which was lower than 4.7% in patients belonging to the RCS group (P = 0.012) for both high- and low-risk patients.","[{'ForeName': 'Qisheng', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Shanghai Fourth People's Hospital, Tongji University School of Medicine, Shanghai, 200081, China. zhangqish@hotmail.com.""}, {'ForeName': 'Yucui', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': ""Department of Gastroenterology, Shanghai Fourth People's Hospital, Tongji University School of Medicine, Shanghai, 200081, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, Shanghai Fourth People's Hospital, Tongji University School of Medicine, Shanghai, 200081, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': ""Department of Gastroenterology, Shanghai Fourth People's Hospital, Tongji University School of Medicine, Shanghai, 200081, China.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Bing', 'Affiliation': ""Department of Gastroenterology, Shanghai Fourth People's Hospital, Tongji University School of Medicine, Shanghai, 200081, China.""}, {'ForeName': '', 'Initials': '', 'LastName': 'Han', 'Affiliation': ""Department of Gastroenterology, Shanghai Fourth People's Hospital, Tongji University School of Medicine, Shanghai, 200081, China.""}]",Surgical endoscopy,['10.1007/s00464-020-07964-z']
2503,32909208,Assessing organic material on single-use vessel sealing devices: a comparative study of reprocessed and new LigaSure™ devices.,"BACKGROUND


Reprocessed devices must be thoroughly cleaned prior to sterilization to ensure efficacy of sterilization agents. Many single-use devices are not designed to be thoroughly cleaned. Interlocking design features inherent to LigaSure™ vessel sealing devices may prevent thorough cleaning and promote accumulation of human tissue that cannot be removed. Thus, the aim of this study was to compare industry reprocessed and new LigaSure™ vessel sealing devices for organic material.
METHODS


A total of 168, 84 new and 84 reprocessed, vessel sealing devices were disassembled and inspected for the presence of residual organic matter using visual, microscopic, and chemical analysis. Devices were randomized and test conductors blinded to group membership. Devices were aseptically disassembled and sent through visual inspection. Next, devices were either examined using light microscopy, scanning electron microscopy (SEM) or exposed to a solution that luminesces in the presence of hemoglobin. Additionally, 165 reprocessed devices were sent to a 3rd party lab for sterility testing via direct immersion culture for 14 days.
RESULTS


Significant amounts of remnant organic material (C, N, O, S, Na, P) were observed with 81/84 reprocessed and 0/84 new devices failing inspection protocols. When tested for the presence of hemoglobin, only 1/12 reprocessed devices passed inspection. SEM of reprocessed devices revealed residues with liquid patterns and diffuse soiling with foreign material. Sterility testing of reprocessed devices revealed a sterility level < 6 -3 .
CONCLUSIONS


The abundance of material resembling human tissue observed on reprocessed VSDs suggests inadequate cleaning prior to sterilization. Atomic and morphological analyses of the remnant materials suggest that bacterial biofilms could also be present. Additionally, surface degradation and release of reinforcing glass fibers from the device were observed. Devices designed for single use can harbor significant amounts of remnant material that likely interfere with the sterilization process.",2020,"When tested for the presence of hemoglobin, only 1/12 reprocessed devices passed inspection.",[],[],"['remnant organic material (C, N, O, S, Na, P']",[],[],"[{'cui': 'C0520510', 'cui_str': 'Material'}]",,0.0938752,"When tested for the presence of hemoglobin, only 1/12 reprocessed devices passed inspection.","[{'ForeName': 'Swathi Ramesh', 'Initials': 'SR', 'LastName': 'Chivukula', 'Affiliation': 'Department of Bioengineering, University of Colorado Denver | Anschutz Medical Campus, 12705 E. Montview Blvd., Ste. 100, Mail Stop 8607, Aurora, CO, 80045, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lammers', 'Affiliation': 'Department of Bioengineering, University of Colorado Denver | Anschutz Medical Campus, 12705 E. Montview Blvd., Ste. 100, Mail Stop 8607, Aurora, CO, 80045, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wagner', 'Affiliation': 'Department of Bioengineering, University of Colorado Denver | Anschutz Medical Campus, 12705 E. Montview Blvd., Ste. 100, Mail Stop 8607, Aurora, CO, 80045, USA. Jennifer.Wagner@cuanschutz.edu.'}]",Surgical endoscopy,['10.1007/s00464-020-07969-8']
2504,32909218,"Patient Perspectives of Quality of the Same-Day Antiretroviral Therapy Initiation Process in Gauteng Province, South Africa: Qualitative Dominant Mixed-Methods Analysis of the SLATE II Trial.","BACKGROUND


HIV patients in South Africa continue to report operational barriers to starting antiretroviral therapy (ART). In the Simplified Algorithm for Treatment Eligibility (SLATE) II trial, same-day initiation (SDI) of ART increased the number of patients commencing ART and achieving HIV viral suppression by using a screening tool to distinguish between patients eligible for SDI and those requiring additional care before starting treatment. We conducted a mixed-methods evaluation to explore trial patients' perceptions and experiences of SDI.
METHODS


SLATE II was implemented at three urban, public primary health care clinics in Gauteng Province, South Africa. We conducted a short quantitative survey and in-depth interviews among a purposive sample of 89 of the 593 trial participants in the intervention and standard arms, using a mixed inductive-deductive framework approach.
RESULTS


Nearly all respondents (95%) were satisfied with their care, despite reporting clinic wait times of ≥ 3 h (72%). Intervention patients found the initiation process to be easy; standard patients found it complicated and were frustrated with being shuffled around the clinic. No intervention arm patients felt that SDI was ""too fast"" or indicated a preference for a more gradual process. Both groups highlighted the need for good counselling and non-judgmental, respectful staff. Standard patients suggested improving patient-provider relations, strengthening counselling, reducing wait times, and minimising referrals.
CONCLUSIONS


While it is difficult to untangle the role of providers from that of the SLATE algorithm in influencing patient experiences, adoption of SLATE II implementation procedures could improve patient experience of treatment initiation.
TRIAL REGISTRATION


Clinicaltrials.gov NCT03315013, registered October 19, 2017.",2020,Intervention patients found the initiation process to be easy; standard patients found it complicated and were frustrated with being shuffled around the clinic.,"[""trial patients' perceptions and experiences of SDI"", 'short quantitative survey and in-depth interviews among a purposive sample of 89 of the 593 trial participants in the intervention and standard arms, using a mixed inductive-deductive framework approach', 'Gauteng Province, South Africa', 'SLATE II was implemented at three urban, public primary health care clinics in Gauteng Province, South Africa', 'patient experiences', 'HIV patients in South Africa']",[],"['patient-provider relations, strengthening counselling, reducing wait times, and minimising referrals']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]",,0.198945,Intervention patients found the initiation process to be easy; standard patients found it complicated and were frustrated with being shuffled around the clinic.,"[{'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA. nscott@bu.edu.'}, {'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Maskew', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Ingrid E', 'Initials': 'IE', 'LastName': 'Olson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Alana T', 'Initials': 'AT', 'LastName': 'Brennan', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}, {'ForeName': 'Lungisile', 'Initials': 'L', 'LastName': 'Vezi', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, 801 Massachusetts Ave 3rd Floor, Boston, MA, 02118, USA.'}]",The patient,['10.1007/s40271-020-00437-4']
2505,32909222,The effect of an inpatient geriatric stewardship on drug-related problems reported by patients after discharge.,"Background Drug-related problems after discharge are common among older adults with polypharmacy. Medication review during hospitalization has been proposed as one solution. Inpatient medication review is often based on clinical records only. An obstacle is the lack of insight into the outpatient history. Therefore, a geriatric stewardship was designed and involved an inpatient medication review by a hospital pharmacist and geriatrician based on (I) clinical records to draft initial recommendations, (II) consultations with primary care providers (general practitioner and community pharmacist) to discuss the hospital-based recommendations, (III) patient interviews to assess their needs, and (IV) a multidisciplinary evaluation of all previous steps to draft final recommendations. Objective To assess the effect of the geriatric stewardship on drug-related problems reported by patients after discharge. Setting General teaching hospital. Methods An implementation study (pre-post design) was performed. Orthopaedic and surgical patients (≥ 65 years) with polypharmacy and a frailty risk factor were included. The pre-group received usual care, the post-group received the geriatric stewardship intervention. Two weeks post-discharge, patient-reported drug-related problems were assessed using a validated questionnaire. Drug-related problems were classified into drug-related complaints, practical problems, and questions about medication. Outcomes The outcomes were the number and type of drug-related problems per patient (primary) and the number of initial recommendations that were altered due to primary care provider and patient input (secondary). Results In total, 127 patients were analysed (usual care n = 74, intervention n = 53). Intervention patients reported fewer drug-related problems compared to usual care: 2.8 versus 3.3 per patient (Adjusted relative risk 0.83, 95% confidence interval 0.66-1.05). This difference resulted from a halving in drug-related complaints (p < 0.05), for example pain, drowsiness, nausea or constipation. Nearly 30% of the initial recommendations based on the clinical records were discarded or modified after primary care provider consultations and patient interviews. Conclusion The geriatric stewardship did not significantly reduce drug-related problems, but it significantly halved drug-related complaints. One-in-three initial recommendations were altered due to primary care provider and patient input. Inpatient medication reviews should not be based on clinical records only; they require transmural collaboration and patient participation to ensure continuity of patient care.",2020,"The geriatric stewardship did not significantly reduce drug-related problems, but it significantly halved drug-related complaints.","['127 patients were analysed (usual care n\u2009=\u200974, intervention n\u2009=\u200953', '65\xa0years) with polypharmacy and a frailty risk factor were included', 'older adults with polypharmacy', 'Orthopaedic and surgical patients (≥']","['usual care, the post-group received the geriatric stewardship intervention']","['drug-related problems', 'example pain, drowsiness, nausea or constipation', 'number and type of drug-related problems per patient (primary) and the number of initial recommendations that were altered due to primary care provider and patient input (secondary']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0457591', 'cui_str': 'Type of drug'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",127.0,0.0503304,"The geriatric stewardship did not significantly reduce drug-related problems, but it significantly halved drug-related complaints.","[{'ForeName': 'Godelieve H M', 'Initials': 'GHM', 'LastName': 'Ponjee', 'Affiliation': 'Department of Clinical Pharmacy, OLVG Hospital, Jan Tooropstraat 164, 1061AE, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk W P C', 'Initials': 'HWPC', 'LastName': 'van de Meerendonk', 'Affiliation': 'Section of Geriatric Medicine, Department of Internal Medicine, OLVG Hospital, Jan Tooropstraat 164, 1061AE, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjo J A', 'Initials': 'MJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Clinical Pharmacy, OLVG Hospital, Jan Tooropstraat 164, 1061AE, Amsterdam, The Netherlands.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Karapinar-Çarkit', 'Affiliation': 'Department of Clinical Pharmacy, OLVG Hospital, Jan Tooropstraat 164, 1061AE, Amsterdam, The Netherlands. f.karapinar@olvg.nl.'}]",International journal of clinical pharmacy,['10.1007/s11096-020-01133-x']
2506,32199246,The influence of cognitive load on susceptibility to audio.,"In this study we evaluate how cognitive load affects susceptibility to auditory signals. Previous research has used the frontal P3 (fP3) event related potential response to auditory novel stimuli as an index for susceptibility to auditory signals. This work demonstrated that tasks that induce cognitive load such as visual and manual tasks, reduced susceptibility. It is however unknown whether cognitive load without visual or manual components also reduces susceptibility. To investigate this, we induced cognitive load by means of the verb generation task, in which participants need to think about a verb that matches a noun. The susceptibility to auditory signals was measured by recording the event related potential in response to a successively presented oddball probe stimulus at 3 different inter-stimulus intervals, 0 ms, 200 ms or 400 ms after the offset of the noun from the verb generation task. An additional control baseline condition, in which oddball response was probed without a verb generation task, was also included. Results show that the cognitive load associated with the verb task reduces fP3 response (and associated auditory signal susceptibility) compared to baseline, independent of presentation interval. This suggests that not only visual and motor processing, but also cognitive load without visual or manual components, can reduce susceptibility to auditory signals and alerts.",2020,"The susceptibility to auditory signals was measured by recording the event related potential in response to a successively presented oddball probe stimulus at 3 different inter-stimulus intervals, 0 ms, 200 ms or 400 ms after the offset of the noun from the verb generation task.",[],[],"['fP3 response (and associated auditory signal susceptibility', 'susceptibility to auditory signals']",[],[],"[{'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.0363092,"The susceptibility to auditory signals was measured by recording the event related potential in response to a successively presented oddball probe stimulus at 3 different inter-stimulus intervals, 0 ms, 200 ms or 400 ms after the offset of the noun from the verb generation task.","[{'ForeName': 'Remo M A', 'Initials': 'RMA', 'LastName': 'van der Heiden', 'Affiliation': 'Utrecht University, Department of Experimental Psychology, Utrecht, the Netherlands; Helmholtz Institute, Utrecht, the Netherlands. Electronic address: r.m.a.vanderheiden@uu.nl.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Janssen', 'Affiliation': 'Utrecht University, Department of Experimental Psychology, Utrecht, the Netherlands; Helmholtz Institute, Utrecht, the Netherlands.'}, {'ForeName': 'Stella F', 'Initials': 'SF', 'LastName': 'Donker', 'Affiliation': 'Utrecht University, Department of Experimental Psychology, Utrecht, the Netherlands; Helmholtz Institute, Utrecht, the Netherlands.'}, {'ForeName': 'J Leon', 'Initials': 'JL', 'LastName': 'Kenemans', 'Affiliation': 'Utrecht University, Department of Experimental Psychology, Utrecht, the Netherlands; Helmholtz Institute, Utrecht, the Netherlands.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103058']
2507,32203735,Accelerating reading via local priming.,"Visual nonlinguistic local and global priming can change one's state of mind and influence other upcoming tasks. Reading involves both detailed and higher-level global processing. Little is known about the effects of visual non-linguistic priming on lower level processing of words, as well as about the potentially higher-level processing of written information. In two experiments, the effects of global versus local priming on single word reading (Experiment 1) as well as text reading (Experiment 2) were investigated in adults. The results revealed facilitation effects of local priming on single word reading as well as on text reading rate, with no impairment of reading accuracy and comprehension. These novel results are further interpreted within different cognitive and neurological frameworks. In addition, clinical and research implications for the local/global attention and reading domain are discussed.",2020,"The results revealed facilitation effects of local priming on single word reading as well as on text reading rate, with no impairment of reading accuracy and comprehension.",[],[],"['facilitation effects of local priming on single word reading as well as on text reading rate, with no impairment of reading accuracy and comprehension']",[],[],"[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",2.0,0.0219972,"The results revealed facilitation effects of local priming on single word reading as well as on text reading rate, with no impairment of reading accuracy and comprehension.","[{'ForeName': 'Goni', 'Initials': 'G', 'LastName': 'Viterbo', 'Affiliation': 'E.J.S Brain Research Center for the Study of Learning Disabilities, University of Haifa, Israel.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Katzir', 'Affiliation': 'E.J.S Brain Research Center for the Study of Learning Disabilities, University of Haifa, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Goldfarb', 'Affiliation': 'E.J.S Brain Research Center for the Study of Learning Disabilities, University of Haifa, Israel. Electronic address: goldfarb@edu.haifa.ac.il.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103056']
2508,32220766,Distinct affective responses to second- and third-party norm violations.,"Social norm violations provoke strong emotional reactions that often culminate in punishment of the wrongdoer. This is true not only when we are the victims of the norm violation (second-party), but also when witnessing a complete stranger being victimized (third-party). What remains unclear, however, is whether second- and third-party punishments are associated with different emotions. To address this question, here we examine how subjects respond affectively to both second- and third-party norm violations in an economic game. Our results indicate that while second- and third-parties respond to norm violations by punishing wrongdoers similarly, they report experiencing distinct emotional states as a result of the violation. Specifically, we observed a cross-over interaction between anger and moral outrage depending on the party's context: while anger was more frequently reported for second- than for third-party violations, moral outrage was more evoked by third-party than second-party violations. Disgust and sadness were the most prevalently reported emotions, but their prevalence were unaffected by party contexts. These results indicate that while responses to second- and third-party violations result in similar punishment, they are associated with the expression of distinct affective palettes. Further, our results provide additional evidence that moral outrage is a critical experience in the evaluation of third-party wrongdoings.",2020,"Specifically, we observed a cross-over interaction between anger and moral outrage depending on the party's context: while anger was more frequently reported for second- than for third-party violations, moral outrage was more evoked by third-party than second-party violations.",[],[],[],[],[],[],,0.0162221,"Specifically, we observed a cross-over interaction between anger and moral outrage depending on the party's context: while anger was more frequently reported for second- than for third-party violations, moral outrage was more evoked by third-party than second-party violations.","[{'ForeName': 'Lauren E S', 'Initials': 'LES', 'LastName': 'Hartsough', 'Affiliation': 'Department of Psychology, Vanderbilt University, PMB 407817, 2301 Vanderbilt Place, Nashville, TN, 37240, United States of America. Electronic address: lauren.hartsough@vanderbilt.edu.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ginther', 'Affiliation': 'Department of Psychology, Vanderbilt University, PMB 407817, 2301 Vanderbilt Place, Nashville, TN, 37240, United States of America.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Marois', 'Affiliation': 'Department of Psychology, Vanderbilt University, PMB 407817, 2301 Vanderbilt Place, Nashville, TN, 37240, United States of America.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103060']
2509,30659284,"Better mind, better work: effects of plants on adolescent mental stress as measured by EEG.",,2019,,[],[],['adolescent mental stress'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]",,0.016105,,"[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. ahmaduaf1416@gmail.com.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'College of Forestry, Guizhou University, Huaxi, Guiyang, 550025, China.'}, {'ForeName': 'Chen Qi', 'Initials': 'CQ', 'LastName': 'Bing', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. cqb@sicau.edu.cn.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yinggao', 'Affiliation': 'College of Forestry, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China. 499130793@qq.com.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}, {'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Nian', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}, {'ForeName': 'Lv', 'Initials': 'L', 'LastName': 'Bing-Yang', 'Affiliation': 'College of Landscape Architecture, Sichuan Agricultural University, Chengdu, Sichuan, 611130, China.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0209-7']
2510,32902785,Evaluating the effectiveness of localized sub-Tenon's anesthesia in 23-gauge vitreoretinal surgery.,"PURPOSE


To evaluate the effectiveness of localized sub-Tenon's anesthesia for pain control during 23-gauge vitreoretinal surgery.
METHODS


Eighty patients were randomly divided into two groups as localized sub-Tenon's (group 1, n = 41) and retrobulbar (group 2, n = 39) anesthesia groups. In group 1, a small volume of anesthetic was injected into the sub-Tenon's capsules at the trocar entry sites. The 23-gauge vitreoretinal surgery was performed in all patients. In both groups, the pain levels during the surgical steps were evaluated using the visual analog pain scale.
RESULTS


Patients in group 1 experienced less pain than group 2 patients did during placement of the trocars and scleral depression (p = 0.041, p = 0.029). Pain during laser photocoagulation was higher in group 1 (p = 0.008). There was no serious complication due to anesthesia or surgery.
CONCLUSION


Localized sub-Tenon's anesthesia is as effective as retrobulbar anesthesia in many steps of vitreoretinal surgery for providing pain control. It can be considered an alternative form of local anesthesia.",2020,"RESULTS


Patients in group 1 experienced less pain than group 2 patients did during placement of the trocars and scleral depression (p = 0.041, p = 0.029).","['Eighty patients', '23-gauge vitreoretinal surgery']","['Localized', ""localized sub-Tenon's anesthesia"", 'retrobulbar', '23-gauge vitreoretinal surgery']","['scleral depression', 'pain levels', 'visual analog pain scale', 'Pain during laser photocoagulation', 'pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}]","[{'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0459804', 'cui_str': 'Retrobulbar space'}, {'cui': 'C0456564', 'cui_str': 'Gauges'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}]",80.0,0.0170196,"RESULTS


Patients in group 1 experienced less pain than group 2 patients did during placement of the trocars and scleral depression (p = 0.041, p = 0.029).","[{'ForeName': 'Atilla', 'Initials': 'A', 'LastName': 'Alpay', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Zonguldak Bülent Ecevit University, Zonguldak, Turkey. atillaalpay@hotmail.com.'}, {'ForeName': 'Tuncer', 'Initials': 'T', 'LastName': 'Güney', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Nişantaşı University, Istanbul, Turkey.'}]",International ophthalmology,['10.1007/s10792-020-01566-3']
2511,32902808,Predictors and Outcomes of Neurological Deterioration in Intracerebral Hemorrhage: Results from the TICH-2 Randomized Controlled Trial.,"Neurological deterioration is common after intracerebral hemorrhage (ICH). We aimed to identify the predictors and effects of neurological deterioration and whether tranexamic acid reduced the risk of neurological deterioration. Data from the Tranexamic acid in IntraCerebral Hemorrhage-2 (TICH-2) randomized controlled trial were analyzed. Neurological deterioration was defined as an increase in National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 or a decline in Glasgow Coma Scale of ≥ 2. Neurological deterioration was considered to be early if it started ≤ 48 h and late if commenced between 48 h and 7 days after onset. Logistic regression was used to identify predictors and effects of neurological deterioration and the effect of tranexamic acid on neurological deterioration. Of 2325 patients, 735 (31.7%) had neurological deterioration: 590 (80.3%) occurred early and 145 (19.7%) late. Predictors of early neurological deterioration included recruitment from the UK, previous ICH, higher admission systolic blood pressure, higher NIHSS, shorter onset-to-CT time, larger baseline hematoma, intraventricular hemorrhage, subarachnoid extension and antiplatelet therapy. Older age, male sex, higher NIHSS, previous ICH and larger baseline hematoma predicted late neurological deterioration. Neurological deterioration was independently associated with a modified Rankin Scale of > 3 (aOR 4.98, 3.70-6.70; p < 0.001). Tranexamic acid reduced the risk of early (aOR 0.79, 0.63-0.99; p = 0.041) but not late neurological deterioration (aOR 0.76, 0.52-1.11; p = 0.15). Larger hematoma size, intraventricular and subarachnoid extension increased the risk of neurological deterioration. Neurological deterioration increased the risk of death and dependency at day 90. Tranexamic acid reduced the risk of early neurological deterioration and warrants further investigation in ICH. URL: https://www.isrctn.com Unique identifier: ISRCTN93732214.",2020,"Tranexamic acid reduced the risk of early (aOR 0.79, 0.63-0.99; p = 0.041) but not late neurological deterioration (aOR 0.76, 0.52-1.11; p = 0.15).",['Intracerebral Hemorrhage'],"['tranexamic acid', 'Tranexamic acid']","['neurological deterioration', 'risk of early neurological deterioration', 'Neurological Deterioration', 'risk of neurological deterioration', 'early neurological deterioration included recruitment from the UK, previous ICH, higher admission systolic blood pressure, higher NIHSS, shorter onset-to-CT time, larger baseline hematoma, intraventricular hemorrhage, subarachnoid extension and antiplatelet therapy', 'National Institutes of Health Stroke Scale (NIHSS) of ≥\u20094 or a decline in Glasgow Coma Scale', 'late neurological deterioration', 'modified Rankin Scale', 'Neurological deterioration']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",2325.0,0.0583813,"Tranexamic acid reduced the risk of early (aOR 0.79, 0.63-0.99; p = 0.041) but not late neurological deterioration (aOR 0.76, 0.52-1.11; p = 0.15).","[{'ForeName': 'Zhe Kang', 'Initials': 'ZK', 'LastName': 'Law', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Dineen', 'Affiliation': 'Radiological Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Cala', 'Affiliation': 'School of Medicine, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Mistri', 'Affiliation': 'Stroke Medicine, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Appleton', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Serefnur', 'Initials': 'S', 'LastName': 'Ozturk', 'Affiliation': 'Department of Neurology, Selcuk University Medical Faculty, Konya, Turkey.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bereczki', 'Affiliation': 'Department of Neurology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ciccone', 'Affiliation': 'Neurology Unit, Azienda Socio Sanitaria Territoriale di Mantova, Mantua, Italy.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, NG5 1PB, UK.'}, {'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Sprigg', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital, Nottingham, NG5 1PB, UK. nikola.sprigg@nottingham.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational stroke research,['10.1007/s12975-020-00845-6']
2512,32902856,Preventing smoking relapse in patients with cancer: A randomized controlled trial.,"BACKGROUND


Abstaining from smoking after a cancer diagnosis is critical to mitigating the risk of multiple adverse health outcomes. Although many patients with cancer attempt to quit smoking, the majority relapse. The current randomized controlled trial evaluated the efficacy of adapting an evidence-based smoking relapse prevention (SRP) intervention for patients with cancer.
METHODS


The trial enrolled 412 patients newly diagnosed with cancer who had recently quit smoking. Participants were randomized to usual care (UC) or SRP. Participants in the UC group received the institution's standard of care for treating tobacco use. Participants in the SRP group in addition received a targeted educational DVD plus a validated self-help intervention for preventing smoking relapse. The primary outcome was smoking abstinence at 2 months, 6 months, and 12 months.
RESULTS


Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20). At 12 months, abstinence rates among survivors were 68% for those in the SRP group and 63% for those in the UC group (P = .38). Post hoc analyses revealed that across 2 months and 6 months, patients who were married/partnered were more likely to be abstinent after SRP than UC (P = .03).
CONCLUSIONS


A smoking relapse prevention intervention did not reduce relapse rates overall, but did appear to have benefited those participants who had the social support of a partner. Future work is needed to extend this effect to the larger population of patients.",2020,"RESULTS


Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20).","['412 patients newly diagnosed with cancer who had recently quit smoking', 'patients with cancer']","['usual care (UC) or SRP', 'targeted educational DVD plus a validated self-help intervention', 'evidence-based smoking relapse prevention (SRP) intervention']","['abstinence rates', 'smoking abstinence', 'Abstinence rates', 'smoking relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",412.0,0.109029,"RESULTS


Abstinence rates for participants in the SRP and UC groups were 75% versus 71% at 2 months and 69% versus 64% at 6 months (Ps > .20).","[{'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Oncologic Sciences, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Martinez', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Palmer', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Healthcare Delivery Research Program, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Judith C', 'Initials': 'JC', 'LastName': 'McCaffrey', 'Affiliation': 'Department of Otolaryngology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Haura', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center, Tampa, Florida.'}]",Cancer,['10.1002/cncr.33162']
2513,32897905,Low blood pressure and adverse outcomes in acute stroke: HeadPoST study explanations.,"OBJECTIVE


As uncertainties exist over underlying causes, we aimed to define the characteristics and prognostic significance of low blood pressure (BP) early after the onset of acute stroke.
METHODS


Post hoc analyzes of the international Head Positioning in acute Stroke Trial (HeadPoST), a pragmatic cluster-crossover randomized trial of lying flat versus sitting up in stroke patients from nine countries during 2015-2016. Associations of baseline BP and death or dependency [modified Rankin scale (mRS) scores 3-6] and serious adverse events (SAEs) at 90 days were assessed in generalized linear mixed models with adjustment for multiple confounders. SBP and DBP was analysed as continuous measures fitted with a cubic spline, and as categorical measures with low (<10th percentile) and high (≥140 and ≥90 mmHg, respectively) levels compared with a normal range (≥10th percentile; 120-139 and 70-89 mmHg, respectively).
RESULTS


Among 11 083 patients (mean age 68 years, 39.9% women) with baseline BP values, 7.2 and 11.7% had low SBP (<120 mmHg) and DBP (<70 mmHg), respectively. Patients with low SBP were more likely to have preexisting cardiac and ischemic stroke and functional impairment, and to present earlier with more severe neurological impairment than other patients. Nonlinear 'J-shaped' relationships of BP and poor outcome were apparent: compared with normal SBP, those with low SBP had worse functional outcome (adjusted odds ratio 1.27, 95% confidence interval 1.02-1.58) and more SAEs, particularly cardiac events, with adjustment for potential confounders to minimize reverse causation. The findings were consistent for DBP and were stronger for ischemic rather than hemorrhagic stroke.
CONCLUSION


The prognostic significance of low BP on poor outcomes in acute stroke was not explained by reverse causality from preexisting cardiovascular disease, and propensity towards greater neurological deficits and cardiac events. These findings provide support for the hypothesis that low BP exacerbates cardiac and cerebral ischemia in acute ischemic stroke.",2020,"The prognostic significance of low BP on poor outcomes in acute stroke was not explained by reverse causality from preexisting cardiovascular disease, and propensity towards greater neurological deficits and cardiac events.","['stroke patients from nine countries during 2015-2016', 'acute stroke', 'Among 11\u200a083 patients (mean age 68 years, 39.9% women) with baseline BP values, 7.2 and 11.7% had low SBP (<120\u200ammHg) and DBP (<70\u200ammHg), respectively', 'Patients with low SBP']",['lying flat versus sitting up'],"['preexisting cardiac and ischemic stroke and functional impairment', 'SBP and DBP', 'severe neurological impairment', 'baseline BP and death or dependency [modified Rankin scale (mRS) scores 3-6] and serious adverse events (SAEs', 'Low blood pressure and adverse outcomes', 'functional outcome', 'low blood pressure (BP']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]","[{'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",11083.0,0.156609,"The prognostic significance of low BP on poor outcomes in acute stroke was not explained by reverse causality from preexisting cardiovascular disease, and propensity towards greater neurological deficits and cardiac events.","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurología and Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurología and Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Brunser', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurología and Psiquiatría, Clínica Alemana de Santiago, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital Melbourne and Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service - Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Ribeirão Preto - SP, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}]",Journal of hypertension,['10.1097/HJH.0000000000002649']
2514,32897924,Assessing the Impact of a Pharmacist-Managed Discharge Medication Reconciliation Pilot at a Community Hospital System.,"INTRODUCTION


With unintended medication discrepancy rates ranging from 30% to 70%, a formal discharge medication reconciliation process must be developed. One strategy shown to reduce medication errors is a pharmacist medication review at discharge. The purpose of this study is to determine the impact of a pharmacist-driven discharge medication reconciliation program.
METHODS


The intervention group included pharmacist-reviewed patients with a high risk of unplanned readmission score and had a discharge order signed during a 2-month period. The control group included eligible patients who were not reviewed by a pharmacist. The after-visit summaries for both groups were then reviewed for additional medication discrepancies.
RESULTS


This study included 140 patients, with 70 patients in each group. A total of 176 discrepancies were identified in the intervention group and 235 were found in the control group. The median number of discrepancies per patient was not statistically different between groups (2 vs. 2, p-value = .196). There were 22 and 24 30-day hospital readmissions in the intervention and control groups, respectively (p-value = .857).
CONCLUSIONS


More medication discrepancies were identified in the control group compared to pharmacist-reviewed patients. More robust studies including a pharmacist dedicated to discharge medication reconciliation should be conducted to identify the potential benefit.",2020,"There were 22 and 24 30-day hospital readmissions in the intervention and control groups, respectively (p-value = .857).
","['patients with a high risk of unplanned readmission score and had a discharge order signed during a 2-month period', '140 patients, with 70 patients in each group', 'eligible patients who were not reviewed by a pharmacist']",[],"['30-day hospital readmissions', 'median number of discrepancies per patient']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]",[],"[{'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",176.0,0.0368688,"There were 22 and 24 30-day hospital readmissions in the intervention and control groups, respectively (p-value = .857).
","[{'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Petrovich', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Sweet', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gillian', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Copenhaver', 'Affiliation': ''}]",Journal for healthcare quality : official publication of the National Association for Healthcare Quality,['10.1097/JHQ.0000000000000282']
2515,32897933,A short-term oral corticosteroid for refractory lumbar spinal stenosis: a double-blinded randomized placebo-controlled clinical trial.,"Although epidural corticosteroids have been evaluated for the lumbar spinal stenosis (LSS) as an alternative treatment, oral corticosteroids have not been considered as a possible option for the patients with constant pain who have resistant against routine treatments. Therefore, this study aimed to investigate the efficacy of the short-term, low-dose oral prednisolone for refractory LSS. In this double-blinded randomized placebo-controlled clinical trial, 100 participants with the refractory LSS were selected from the out-patient clinics; however, 7 of them excluded before randomization. The patients were randomly allocated into two groups with a 1:1 ratio: the intervention group that received 10 mg prednisolone per day for 1 week and the control group that received the exact placebo. The patients' severity of pain in terms of the numerical rating scale, ability to walk in meters, and Oswestry Disability Index (ODI) were assessed and then compared to the baseline after 2 months. The baseline variables were NS between these two groups. At the 2-month follow-up, the ability to walk in meters has increased and the severity of pain and ODI have decreased in both groups. Notably, except for the walking distance, none of the differences were statistically significant. Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before). One-week treatment with daily 10 mg oral prednisolone was not effective on the patients with refractory LSS in the short-term follow-up.",2020,"Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before).","['patients with constant pain who have resistant against routine treatments', 'refractory lumbar spinal stenosis', '100 participants with the refractory LSS were selected from the out-patient clinics; however, 7 of them excluded before randomization']","['placebo', 'corticosteroid', 'epidural corticosteroids', 'prednisolone']","['numerical rating scale, ability to walk in meters, and Oswestry Disability Index (ODI', 'walking distance', 'severity of pain and ODI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960160', 'cui_str': 'Constant pain'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",100.0,0.173433,"Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before).","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Akbari Aghdam', 'Affiliation': 'Department of Orthopedic Surgery.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Andalib', 'Affiliation': 'Department of Orthopedic Surgery, Kashani University Hospital.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Asadiyan Ardakani', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Telloo', 'Affiliation': 'Department of Internal Medicine, Firoozgar University Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sheikhbahaei', 'Affiliation': 'Student Research Committee, School of Medicine, Isfahan University of Medical Sciences, Isfahan.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000432']
2516,32897934,Effect of a training program of overground walking on BTS gait parameters in elderly women during single and dual cognitive tasks.,"We tested the hypothesis that a regular training program might reduce gait disturbances during dual cognitive-motor tasks in elderly women. This open-label experimental study comprised 53 postmenopausal women aged over 65, who were assigned to a 10-week training program (360 min/week). A BTS SMART system examination during free walking and during dual tasks [i.e., walking while performing either a simple (SCT) or a complex (CCT) cognitive task] was performed prior to the training program and again after it had finished. After the 10-week walking training program, a significant decrease was found in the duration of single support phase, double support phase, total support phase, and gait cycle, whereas values for such BTS parameters as swing speed, step length, and gait speed increased significantly. The greatest percentage deltas between the final and initial values of the respective BTS parameters concerned swing speed and gait speed irrespective of the kind of task undertaken while measurements were taken. A cognitive task, irrespective of the level of difficulty, performed during walking had the opposite effect on step width than expected. A 10-week training program significantly improved the cadency and manner of gait in elderly women, but did not change step width. Therefore, further study is needed to estimate the usefulness of cognitive-motor training programs for significant improvement in gait coordination during dual tasks in elderly women.",2020,"A 10-week training program significantly improved the cadency and manner of gait in elderly women, but did not change step width.","['53 postmenopausal women aged over 65', 'elderly women', 'elderly women during single and dual cognitive tasks']","['walking while performing either a simple (SCT) or a complex (CCT) cognitive task', 'regular training program', '10-week training program', 'training program of overground walking']","['cadency and manner of gait', 'BTS gait parameters', 'duration of single support phase, double support phase, total support phase, and gait cycle, whereas values for such BTS parameters as swing speed, step length, and gait speed', 'gait disturbances']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0072802', 'cui_str': 'Pyruvic acid'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}]",53.0,0.0113564,"A 10-week training program significantly improved the cadency and manner of gait in elderly women, but did not change step width.","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Hagner-Derengowska', 'Affiliation': 'Department of Physical Culture, Faculty of Earth Sciences and Spatial Management, Nicolaus Copernicus University, Toruń.'}, {'ForeName': 'Krystian', 'Initials': 'K', 'LastName': 'Kałużny', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kałużna', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Sciences.'}, {'ForeName': 'Walery', 'Initials': 'W', 'LastName': 'Zukow', 'Affiliation': 'Department of Physical Culture, Faculty of Earth Sciences and Spatial Management, Nicolaus Copernicus University, Toruń.'}, {'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Leis', 'Affiliation': 'Faculty of Medicine, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Domagalska-Szopa', 'Affiliation': 'Department of Medical Rehabilitation, Faculty of Health Sciences in Katowice, Medical University, Katowice.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Kochański', 'Affiliation': 'University of Bydgoszcz, Bydgoszcz.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Budzyński', 'Affiliation': 'Department of Vascular and Internal Diseases, Faculty of Health Sciences, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University, Toruń, Poland.'}]",International journal of rehabilitation research. Internationale Zeitschrift fur Rehabilitationsforschung. Revue internationale de recherches de readaptation,['10.1097/MRR.0000000000000434']
2517,32898095,Comparison of clinical outcomes of 3 trifocal IOLs.,"PURPOSE


To compare the clinical outcomes obtained after implantation of 1 of 3 models of diffractive trifocal IOLs.
SETTING


Hospital da Luz, Lisbon, Portugal.
DESIGN


Prospective randomized comparative study.
METHODS


Patients undergoing cataract surgery with bilateral implantation of 1 of 3 models of diffractive trifocal IOLs were enrolled. The IOL models implanted were the FineVision POD F, RayOne Trifocal, or the AcrySof IQ PanOptix IOL (30 eyes of 15 patients in each group). Visual acuity (VA), refraction, defocus curve, and contrast sensitivity outcomes were evaluated during a 3-month follow-up. Furthermore, the Quality of Vision questionnaire (QoV) was used to evaluate the frequency, severity, and discomfort of different visual symptoms.
RESULTS


A total of 90 eyes of 45 patients were included. No statistically significant differences were found between groups in distance, intermediate, and near VA (P ≥ .112) and postoperative refraction (P ≥ .059). Postoperative binocular uncorrected intermediate VA of 0.10 logarithm of the minimum angle of resolution (logMAR) or better was found in 14 (93.33%) patients in the 3 groups. Postoperative binocular uncorrected near VA of 0.10 logMAR or better was found in 13 (86.67%), 14 (93.33%), and 13 (86.67%) patients in the POD F, RayOne, and PanOptix IOLs groups, respectively. No statistically significant differences were found between groups in scotopic contrast sensitivity with and without glare and in the QoV scores (P ≥ .057), except for the difference between the POD F and RayOne IOLs groups in depth perception severity, which was less in the RayOne IOL group (P = .019).
CONCLUSIONS


The 3 trifocal IOLs evaluated provided a complete visual restoration with good visual quality outcomes.",2020,"No statistically significant differences were found between groups in scotopic contrast sensitivity with and without glare and in the QoV scores (P ≥ .057), except for the difference between the POD F and RayOne IOLs groups in depth perception severity, which was less in the RayOne IOL group (P = .019).
","['Patients undergoing cataract surgery with bilateral implantation of 1 of 3 models of diffractive trifocal IOLs were enrolled', 'A total of 90 eyes of 45 patients were included', 'Hospital da Luz, Lisbon, Portugal']",[],"['distance, intermediate, and near VA', 'frequency, severity, and discomfort of different visual symptoms', 'QoV scores', 'Visual acuity (VA), refraction, defocus curve, and contrast sensitivity outcomes', 'postoperative refraction', 'Quality of Vision questionnaire (QoV', 'scotopic contrast sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}]",[],"[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0422943', 'cui_str': 'Visual symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",45.0,0.0334335,"No statistically significant differences were found between groups in scotopic contrast sensitivity with and without glare and in the QoV scores (P ≥ .057), except for the difference between the POD F and RayOne IOLs groups in depth perception severity, which was less in the RayOne IOL group (P = .019).
","[{'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'From the Hospital da Luz Lisboa (Ribeiro, Ferreira), Lisbon, Faculdade de Medicina da Universidade de Lisboa (Ribeiro), Lisbon, Visual Sciences Research Centre, University of Lisbon (Ribeiro), Lisbon, Portugal.'}, {'ForeName': 'Tiago B', 'Initials': 'TB', 'LastName': 'Ferreira', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000212']
2518,32898141,A pilot feasibility randomised controlled trial of two behaviour change interventions compared to usual care to reduce substance misuse in looked after children and care leavers aged 12-20 years: The SOLID study.,"BACKGROUND


Young people in state care, often due to abuse or neglect, have a four-fold increased risk of drug and alcohol use compared to their peers.
AIM


The SOLID study aimed to investigate the feasibility of a definitive randomised controlled trial, comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol), and improve mental health, in young people in care.
METHODS


We recruited young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England. Participants were randomised to either i. Motivational Enhancement Therapy (MET), ii. Social Behaviour and Network Therapy (SBNT) or iii. Control (usual care). All interventions were delivered by trained drug and alcohol workers. Follow-up data were collected 12 months post recruitment. Feasibility for trial progression was compared to pre-specified stop: go criteria (recruitment of 60% of eligible participants, 80% of participants attending 60% of offered sessions and retention of 70% of participants at 12 month follow up).
RESULTS


Of 1450 eligible participants, 860 (59%) were screened for drug and alcohol use by social workers, 211 (24.5%) met inclusion criteria for the trial and 112 young people (7.7%) consented and were randomised. Sixty of these 112 participants (54%) completed 12-month follow-up questionnaires. Only 15 out of the 76 (20%) participants allocated to an intervention arm attended any of the offered MET or SBNT sessions.
CONCLUSION


By reference to pre-specified stop: go criteria it is not feasible to conduct a definitive trial for SOLID in its current format. Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here. Future work may require dedicated clinically embedded research resource to evaluate effectiveness of new interventions in services.",2020,"Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here.","['1450 eligible participants, 860 (59%) were screened for drug and alcohol use by social workers, 211 (24.5%) met inclusion criteria for the trial and 112 young people (7.7%) consented and were randomised', 'looked after children and care leavers aged 12-20 years', 'young people in care aged 12-20 years, self-reporting substance use within the previous 12 months and residing in 1 of 6 participating local authority sites in the North East of England', 'young people in care', 'Sixty of these 112 participants (54%) completed 12-month follow-up questionnaires']","['Social Behaviour and Network Therapy (SBNT', 'behaviour change interventions', 'risky substance use (illicit drugs and alcohol', 'usual care', 'Motivational Enhancement Therapy (MET']",['mental health'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4749226', 'cui_str': 'Aging out of youth care system'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0037397', 'cui_str': 'Social behavior'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",1450.0,0.0965647,"Despite co-designing procedures with staff and young people in care, the screening, referral and treatment pathway did not work here.","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Alderson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fouweather', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'School of Psychology, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McArdle', 'Affiliation': 'Child and Adolescent, Mental Health Services, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Smart', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Raghu', 'Initials': 'R', 'LastName': 'Lingam', 'Affiliation': ""Population Child Health Research Group, School of Women and Children's Health, University New South Wales, Randwick, Australia.""}]",PloS one,['10.1371/journal.pone.0238286']
2519,32898170,Intramuscular stimulation vs sham needling for the treatment of chronic midportion Achilles tendinopathy: A randomized controlled clinical trial.,"BACKGROUND


The insertion of filiform needles intramuscularly (a.k.a. intramuscular stimulation/dry needling) has been suggested as a possible treatment for various painful musculoskeletal conditions. Our aim was to answer the question, is intramuscular stimulation more effective than sham intramuscular stimulation/dry needling for the treatment of Achilles tendinopathy?
METHODS


52 participants with persistent midportion Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control) (n = 8). The a priori primary outcome measure was change in VISA-A score at 12 weeks-VISA-A was also measured at 6 weeks, and at 6 and 12 months. Secondary outcome measures include the proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm).
RESULTS


The study retention was 94% at 12 weeks and 88% at 1 year. VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint. The percentage of patients who rated themselves as much or very much improved (i.e. treatment success) was not different after 12 weeks (G3 70%, G2 89%, G1 86% p = 0.94), or at 26 (p = 0.62) or 52 weeks (p = 0.71). No clinically significant effects of intervention group were observed in any of the secondary outcome measures.
CONCLUSION


The addition of intramuscular stimulation to standard rehabilitation for Achilles tendinopathy did not result in any improvement over the expected clinical benefit achieved with exercise-based rehabilitation alone.",2020,"VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint.","['chronic midportion Achilles tendinopathy', '52 participants with persistent midportion', 'Achilles tendinopathy began and 46 completed one of three treatment protocols which were randomly assigned: (G3) a 12-week']","['rehabilitation program of progressive tendon loading plus intramuscular stimulation (n = 25), (G2) the same rehabilitation program but with sham intramuscular stimulation (n = 19), or (G1) a reference group of rehabilitation program alone (as an additional control', 'sham intramuscular stimulation/dry needling', 'Intramuscular stimulation vs sham needling']","['proportion of patients who rated themselves as much or very much improved (%), dorsiflexion range of motion (degrees), and tendon thickness (mm', 'change in VISA-A score', 'VISA-A score']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.107393,"VISA-A score improved in all three groups over time (p<0.0001), with no significant difference among the three groups in VISA-A score at the start of the study (mean ± SD: G3 59 ± 13, G2 57 ± 17, G1 56 ± 22), at 12 weeks (G3 76 ± 14, G2 76 ± 15, G1 82 ± 11) or at any other timepoint.","[{'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Solomons', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Jenny J Y', 'Initials': 'JJY', 'LastName': 'Lee', 'Affiliation': 'Centre for Hip Health and Mobility, Vancouver Coastal Health Research Institute, Vancouver, Canada.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Bruce', 'Affiliation': 'Kinetic Rehabilitation Centre, North Vancouver, Canada.'}, {'ForeName': 'Lynita D', 'Initials': 'LD', 'LastName': 'White', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Scott', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada.'}]",PloS one,['10.1371/journal.pone.0238579']
2520,32898176,Participant experiences of a low-energy total diet replacement programme: A descriptive qualitative study.,"INTRODUCTION


The participants' experience of low-energy total diet replacement (TDR) programmes delivered by lay counsellors in the community for the routine treatment of obesity is currently unclear. We interviewed a sample of twelve participants who took part in the Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET) trial and were randomised to the TDR programme.
METHODS


We purposively sampled twelve patients who took part in the DROPLET trial, and conducted in-depth telephone interviews, which were audio-recorded and transcribed verbatim. Interview questions focused on participants' experiences and perceptions of the TDR programme. We conducted a thematic analysis, actively developing themes from the data, and used the one sheet of paper (OSOP) technique to develop higher-level concepts.
RESULTS


Nine key themes were identified; Reasons for taking part, Expectations, Support and guidance from the counsellor, Time to build a personal relationship, Following the TDR Programme, Adverse events, Outcomes from the TDR, Weight Loss Maintenance, Recommending TDR to others. The relationship between participants and the counsellor was central to many of the themes. Close relationships with counsellors facilitated TDR adherence through providing one-to-one support (including during difficult times), sharing expert knowledge, and building a close relationship. Adherence was also supported by the rapid weight loss that patients reported experiencing. Overall participants reported positive experiences of the TDR, and emphasised the positive impact on their wellbeing.
DISCUSSION


Patients reported that a TDR programme delivered by lay counsellors in the community was a positive experience and effective in helping them to lose weight. Future trials should consider the central role of the person providing support and advice as a key component in the programme.",2020,"Close relationships with counsellors facilitated TDR adherence through providing one-to-one support (including during difficult times), sharing expert knowledge, and building a close relationship.",['twelve participants who took part in the Doctor Referral of Overweight People to Low-Energy total diet replacement Treatment (DROPLET) trial and were randomised to the TDR programme'],"['low-energy total diet replacement (TDR) programmes', 'low-energy total diet replacement programme']",['rapid weight loss'],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0420382', 'cui_str': 'Referral to doctor'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",12.0,0.0292774,"Close relationships with counsellors facilitated TDR adherence through providing one-to-one support (including during difficult times), sharing expert knowledge, and building a close relationship.","[{'ForeName': 'Nerys M', 'Initials': 'NM', 'LastName': 'Astbury', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Albury', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Nourse', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Science, University of Oxford, Radcliffe Primary Care, Oxford, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0238645']
2521,32898192,Pharmacokinetics and bioequivalence assessment of optimized directly compressible Aceclofenac (100 mg) tablet formulation in healthy human subjects.,"The aim of the study was to determine the various pharmacokinetic parameters of the newly developed cost-effective aceclofenac 100 mg tablet formulation (F-15) and to establish the bioequivalence against the marketed brand (ACEMED). Both products (test and reference) were given to 12 healthy non-smokers male subjects with overnight fasting of >10hr. The study was a randomized, single-dose, open-label, two sequence, and two treatment crossover design, with a washout period of 2 weeks. Blood samples (5 mL) from the human subjects were collected before (0 hr) and after drug administration at 13different time points (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 18 hrs). The drug plasma concentration was analyzed by a validated RP-HPLC method using a solvent system containing acetonitrile and deionized water (60:40% v/v). Linearity was found to be 0.999 over the drug concentration range of 50μg/mL to 0.05μg/mL with LLOQ and LOD of 0.05μg/mL and 0.025μg/mL respectively. Non-compartmental pharmacokinetic analysis was performed using Kinetica® (ver. 5.1) software. Using the log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT were calculated. The Cmax of the test and brand was found to be 8.629±1.251μg/mL and 8.478±0.913μg/mL. The AUC0-t and AUC0-∞ of the test and the reference were computed to be 20.890 ±2.2021μg/mL.h, 23.272 ±1.914 μg/mL.h and 19.850 ±2.911 μg/mL.h, 22.890 ± 2.110 μg/mL.h correspondingly. Two-way analysis of variance (ANOVA) test and two one-sided t-test (p>0.05; non-significant) were applied to assess the variation in the period, sequence, subjects, and treatment. Geometric mean ratios for above mentioned pharmacokinetic parameters of reference/test were found within the acceptable FDA limits of 80-125% using 90% CI. There was no inter and intrasubject variation (p> 0.05) that was observed. Therefore, the directly compressible aceclofenac (100 mg) test formulation and the commercial reference tablets were declared to be biosimilar.",2020,There was no inter and intrasubject variation (p> 0.05) that was observed.,"['healthy human subjects', '12 healthy non-smokers male subjects with overnight fasting of >10hr']",['optimized directly compressible Aceclofenac'],"['Geometric mean ratios', 'log-transformed data Cmax, AUC0-t, AUC0-∞, AUMCtot, and MRT', 'drug plasma concentration', 'acceptable FDA limits']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0577306', 'cui_str': 'Compressible'}, {'cui': 'C0050403', 'cui_str': 'aceclofenac'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024943', 'cui_str': 'Mauritania'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",12.0,0.0347567,There was no inter and intrasubject variation (p> 0.05) that was observed.,"[{'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Bushra', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Harris', 'Initials': 'MH', 'LastName': 'Shoaib', 'Affiliation': 'Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Huma', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Ghayas', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.'}]",PloS one,['10.1371/journal.pone.0238951']
2522,32909309,Evaluating the effectiveness of on-road driving remediation following acquired brain injury: A wait-list feasibility study with follow-up.,"INTRODUCTION


Return to driving is an important goal for people recovering from acquired brain injury. Occupational therapy driving assessments aim to determine the impact of acquired brain injury on a person's capacity to drive and may include on-road driving rehabilitation. The primary objective of this project was to conduct a feasibility randomised controlled trial (RCT) of an on-road driving remediation program for adults with acquired brain injury. Secondary objectives were to measure the effectiveness of the on-road driving program and determine sample size required for a randomised controlled trial.
METHODS


A wait-list randomised controlled trial with blinded assessment and 6-month follow-up aimed to recruit 10 participants with acquired brain injury. Concealed methods randomly allocated participants to receive the on-road driving rehabilitation program immediately (intervention group) or after 6 weeks (wait-list group). The primary outcome measure of functional fitness to drive, was assessed pre- and post-intervention, and at 6-month follow-up. Driving performance was measured by percentage of correct manoeuvres and driving instructor intervention.
RESULTS


Eight participants (seven male; average age 46 years; six traumatic brain injury and two stroke) were recruited. The protocol was feasible. Results of the RCT suggest intervention effectiveness initially with two of the three interventions, and no wait-list, participants achieving fitness to drive. This increased to five out of eight participants after the wait-list group completed the intervention. While three participants retained this outcome at 6-month follow-up, universal deterioration in on-road driving performance was evident for all participants at 6-month follow-up.
CONCLUSION


The trial was feasible and findings suggest that on-road driving remediation assists people with acquired brain injury to achieve functional fitness to drive but the skills may not be maintained 6 months later. A full RCT is warranted to further determine the effectiveness of on-road driving remediation and capacity of participants to maintain the skills developed.",2020,The trial was feasible and findings suggest that on-road driving remediation assists people with acquired brain injury to achieve functional fitness to drive but the skills may not be maintained 6 months later.,"['Eight participants (seven male; average age 46\xa0years; six traumatic brain injury and two stroke', '10 participants with acquired brain injury', 'people recovering from acquired brain injury', 'adults with acquired brain injury']","['road driving remediation program', 'RCT']","['Driving performance', 'functional fitness to drive']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",10.0,0.1144,The trial was feasible and findings suggest that on-road driving remediation assists people with acquired brain injury to achieve functional fitness to drive but the skills may not be maintained 6 months later.,"[{'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bassingthwaighte', 'Affiliation': 'Driving Assessment and Rehabilitation Service, Occupational Therapy Department, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Griffin', 'Affiliation': 'Brain Injury Rehabilitation, Occupational Therapy Department, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Gustafsson', 'Affiliation': 'School of Allied Health Sciences, Griffith University, Brisbane, QLD, Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12694']
2523,32909326,"Effect of sour tea supplementation on liver enzymes, lipid profile, blood pressure, and antioxidant status in patients with non-alcoholic fatty liver disease: A double-blind randomized controlled clinical trial.","The aim of this study was to evaluate the efficacy of sour tea supplementation in patients with nonalcoholic fatty liver disease (NAFLD). Seventy NAFLD patients were enrolled in this randomized, double-blind, placebo-controlled clinical trial. Participants received sour tea in the form of a 450 mg capsule or a placebo capsule daily for 8 weeks. Anthropometric indices, liver enzymes, lipid profile, blood pressure, and antioxidant status were evaluated at the baseline and at the end of the study. Sixty-one participants completed the study. After 8 weeks, sour tea administration significantly decreased serum triglyceride (TG) (p = .03), alanine aminotransferase (ALT) (p = .01), and aspartate aminotransferase (AST) (p = .004) levels compared with the placebo. In addition, sour tea supplementation resulted in a significant reduction in systolic blood pressure (SBP) (p = .03) and diastolic blood pressure (DBP) (p = .04), and a significant increase in serum total antioxidant capacity (TAC) levels (p ˂ .001) compared with the placebo. However, no significant changes in anthropometric measures, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol (HDL-c) levels were observed after sour tea supplementation compared with the placebo (p > .05). Sour tea supplementation may be effective in improving serum TG, liver enzymes, and blood pressure in patients diagnosed with NAFLD. Further studies are needed to address the exact mechanism of action of these effects.",2020,"After 8 weeks, sour tea administration significantly decreased serum triglyceride (TG) (p = .03), alanine aminotransferase (ALT) (p = .01), and aspartate aminotransferase (AST) (p = .004) levels compared with the placebo.","['patients with nonalcoholic fatty liver disease (NAFLD', 'patients diagnosed with NAFLD', 'patients with non-alcoholic fatty liver disease', 'Sixty-one participants completed the study', 'Seventy NAFLD patients']","['sour tea supplementation', 'placebo', 'Sour tea supplementation']","['aspartate aminotransferase (AST', 'serum triglyceride (TG', 'systolic blood pressure (SBP', 'alanine aminotransferase (ALT', 'diastolic blood pressure (DBP', 'HDL-c) levels', 'anthropometric measures, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), and high-density lipoprotein cholesterol ', 'serum total antioxidant capacity (TAC) levels', 'liver enzymes, lipid profile, blood pressure, and antioxidant status', 'Anthropometric indices, liver enzymes, lipid profile, blood pressure, and antioxidant status', 'serum TG, liver enzymes, and blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",61.0,0.543918,"After 8 weeks, sour tea administration significantly decreased serum triglyceride (TG) (p = .03), alanine aminotransferase (ALT) (p = .01), and aspartate aminotransferase (AST) (p = .004) levels compared with the placebo.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Izadi', 'Affiliation': 'Food Security Research Center and Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Farrokhzad', 'Affiliation': 'Department of Orthopedics, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Tamizifar', 'Affiliation': 'Isfahan Gastroenterology and Hepatology Research Center (lGHRC), Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Tarrahi', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Entezari', 'Affiliation': 'Food Security Research Center and Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6826']
2524,32909330,Proton pump inhibitors and chronic kidney disease: Reevaluating the evidence from a randomized controlled trial.,,2020,,['chronic kidney disease'],['Proton pump inhibitors'],[],"[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]",[],,0.23115,,"[{'ForeName': 'B Burt', 'Initials': 'BB', 'LastName': 'Gerstman', 'Affiliation': 'Department of Health Science, San Jose State University, San Jose, California, USA.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.5101']
2525,32909336,Mechanism and prevention of facial pressure injuries: a novel emergent strategy supported by a multicenter controlled study in frontline healthcare professionals fighting COVID-19.,"Numerous healthcare professionals fighting COVID-19 worldwide are suffering from the protective respirators related facial pressure injuries. This study explored the mechanism and prevention of such injuries, and devised a novel emergent strategy, which was supported by a multicenter self-controlled study in 1161 frontline healthcare professionals. In this study, according to the anatomy of the face and the characteristics of facial pressure injuries, a respirator liner was designed using a polyurethane foam to redistribute the pressure across the face. A pre-clinical crossover trial was performed on eight participants to evaluate its efficacy. The strategy was then widely applied among 11 100 healthcare workers in seven frontline hospitals, and 1161 of them were sampled for a questionnaire investigation. The pre-clinical crossover trial showed that the novel strategy was very effective in preventing facial pressure injuries. The questionnaire investigation showed that pain score, wearing disturbance, and the incidence of pressure injury in the healthcare professionals were significantly correlated with wearing time (all ρ = 0.986). The new strategy significantly reduced the incidence of pressure injury from 84.7% to 11.1%, pain score IQR from 5 (2) to 1 (2), and wearing disturbance rate from 91.6% to 6.3%, and the results analyzed according to individual hospitals or different wearing time showed similar trends (all P < 0.0005). The protective respirators related facial pressure injuries can be effectively mitigated with this emergent strategy, which has also been applied in some European hospitals and can be popularized to help more healthcare professionals who are combating COVID-19 on the frontlines. This article is protected by copyright. All rights reserved.",2020,"The new strategy significantly reduced the incidence of pressure injury from 84.7% to 11.1%, pain score IQR from 5 (2) to 1 (2), and wearing disturbance rate from 91.6% to 6.3%, and the results analyzed according to individual hospitals or different wearing time showed similar trends (all P < 0.0005).","['11 100 healthcare workers in seven frontline hospitals, and 1161 of them were sampled for a questionnaire investigation', 'facial pressure injuries', '1161 frontline healthcare professionals']",[],"['wearing disturbance rate', 'incidence of pressure injury', 'facial pressure injuries', 'pain score IQR', 'pain score, wearing disturbance, and the incidence of pressure injury']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",8.0,0.027149,"The new strategy significantly reduced the incidence of pressure injury from 84.7% to 11.1%, pain score IQR from 5 (2) to 1 (2), and wearing disturbance rate from 91.6% to 6.3%, and the results analyzed according to individual hospitals or different wearing time showed similar trends (all P < 0.0005).","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital.'}, {'ForeName': 'Xinzhu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital.'}, {'ForeName': 'Shujun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital.'}, {'ForeName': 'Yuezeng', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital.'}, {'ForeName': ""Chuan'an"", 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Department of Burns and Plastic Surgery, The Fourth Medical Center of Chinese PLA General Hospital.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12862']
2526,32909356,Efficacy and Safety of Fecal Microbiota Transplantation by washed preparation in Patients with Moderate to Severe Active Ulcerative Colitis.,"AIM


The role of fecal microbiota transplantation (FMT) for severe ulcerative colitis (UC) is unclear. This study aimed to evaluate the short-term efficacy and safety of FMT by washed preparation for moderate to severe active UC.
METHODS


An open-label, prospective trial was conducted in an inflammatory bowel disease (IBD) tertiary referral center from April 2016 to March 2018. Patients with moderate to severe UC were randomly assigned to undergo FMT three times on day1, day3 and day5 by nasojejunal tube (NJT) or transendoscopic enteral tubing (TET). The primary endpoint was clinical response at week 2 post-FMT. The secondary endpoints were clinical and endoscopic remission at week 12 post-FMT, safety and disease progression.
RESULTS


Nine patients were included. 77.8% (7/9) of the patients achieved clinical response at week 2. 55.6% (5/9) and 33.3% (3/9) achieved clinical remission and endoscopic remission at week 12, respectively. 11.1% (1/9) switched to anti-TNFα therapy and 11.1% (1/9) underwent colectomy. FMT was delivered through NJT in 44.4% (4/9) of the patients, while TET was used in 55.6% (5/9). The clinical outcomes were not significantly different based on the delivery route (p>0.05). Adverse events, which were all mild and self-limited, were observed in 33.3% (3/9) of the patients.
CONCLUSIONS


FMT by washed preparation appears to be a safe and effective adjunct therapy for patients with moderate to severe UC in a short-term follow-up. The efficacy was not significantly different between the FMT delivery routes (NJT or TET). Further randomized controlled studies are needed to confirm these findings. This article is protected by copyright. All rights reserved.",2020,The clinical outcomes were not significantly different based on the delivery route (p>0.05).,"['Patients with Moderate to Severe Active Ulcerative Colitis', 'severe ulcerative colitis (UC', 'Patients with moderate to severe UC', 'patients with moderate to severe UC', 'moderate to severe active UC', 'Nine patients were included', 'inflammatory bowel disease (IBD) tertiary referral center from April 2016 to March 2018']","['Fecal Microbiota Transplantation', 'FMT three times on day1, day3 and day5 by nasojejunal tube (NJT) or transendoscopic enteral tubing (TET', 'fecal microbiota transplantation (FMT', 'FMT']","['clinical remission and endoscopic remission', 'clinical response', 'Adverse events', 'Efficacy and Safety', 'clinical response at week 2 post-FMT', 'clinical and endoscopic remission at week 12 post-FMT, safety and disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",9.0,0.0456009,The clinical outcomes were not significantly different based on the delivery route (p>0.05).,"[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Insurance, Xijing Hospital, Air Force Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yongzhan', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': ""Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Kaichun', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': ""Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yongquan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi, China.""}]",Journal of digestive diseases,['10.1111/1751-2980.12938']
2527,32909468,"Effects of Resistance Exercise on Symptoms, Physical Function, and Quality of Life in Gastrointestinal Cancer Patients Undergoing Chemotherapy.","This research aimed to investigate the effects of resistance exercise on symptoms, physical function, and quality of life (QoL) in gastrointestinal cancer patients undergoing chemotherapy. Patients were quasi-randomly divided into the resistance exercise group and the relaxation control group, and machine-based resistance exercise was performed twice a week for 12 weeks under the guidance of experienced therapists. The QoL of patients was analyzed by EORTC-QLQ-C30. Resistance exercise training significantly reduced the incidences of lack of energy (inter-group  P  = .011), nausea (inter-group  P  = .007), acid reflux (inter-group  P  = .042), and back pain (inter-group  P  = .0009). Twelve weeks of resistance exercise training significantly elevated the muscular strength of leg press (inter-group  P  = .021) and leg extension (inter-group  P  = .041), and the muscular endurance of leg press (inter-group  P  = .005). The participants' performance in 6-m fast walk (inter-group  P  = .008), 6-m backwards walk (inter-group  P  = .016), and chair rise (inter-group  P  = .031) were dramatically improved. Fatigue (inter-group  P  = .024) and appetite loss (inter-group  P  = .012) in the resistance exercise group were significantly lower than the relaxation control group. In conclusion, the beneficial effects of resistance exercise on symptoms, physical function and QoL in gastrointestinal cancer patients undergoing chemotherapy were demonstrated. Resistance exercise training reduced the incidences of nausea and acid reflux, improved physical function, and alleviated fatigue and appetite loss in gastrointestinal cancer patients undergoing chemotherapy.",2020,"Twelve weeks of resistance exercise training significantly elevated the muscular strength of leg press (inter-group  P  = .021) and leg extension (inter-group  P  = .041), and the muscular endurance of leg press (inter-group  P  = .005).","['gastrointestinal cancer patients undergoing chemotherapy', 'Gastrointestinal Cancer Patients Undergoing Chemotherapy']","['Resistance Exercise', 'resistance exercise', 'Resistance exercise training', 'resistance exercise group and the relaxation control group, and machine-based resistance exercise', 'resistance exercise training']","['leg extension', 'symptoms, physical function, and quality of life (QoL', 'muscular endurance of leg press', 'chair rise', 'Symptoms, Physical Function, and Quality of Life', 'acid reflux', 'symptoms, physical function and QoL', 'appetite loss', 'nausea', 'back pain', 'muscular strength of leg press', 'nausea and acid reflux, improved physical function, and alleviated fatigue and appetite loss', 'incidences of lack of energy', 'Fatigue']","[{'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.0236166,"Twelve weeks of resistance exercise training significantly elevated the muscular strength of leg press (inter-group  P  = .021) and leg extension (inter-group  P  = .041), and the muscular endurance of leg press (inter-group  P  = .005).","[{'ForeName': 'Yijin', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Biyu', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}]",Integrative cancer therapies,['10.1177/1534735420954912']
2528,32909491,Building Capacity for Medication Assisted Treatment in Rural Primary Care Practices: The IT MATTTRs Practice Team Training.,"OBJECTIVES


In response to rural communities and practice concerns related to opioid use disorder (OUD), the Implementing Technology and Medication Assisted Treatment Team Training in Rural Colorado study (IT MATTTRs) developed a training intervention for full primary care practice (PCP) teams in MAT for OUD. This evaluation reports on training implementation, participant satisfaction, and impact on perceived ability to deliver MAT.
METHODS


PCPs in the High Plains Research Network and Colorado Research Network were randomized to receive team training either in-person or through virtual tele-mentoring. Training attendance logs recorded the number of participants and their roles. Participants completed a survey within one month of the last training session to evaluate satisfaction and ability to deliver components of MATs.
RESULTS


441 team members at 42 PCPs were trained, including 22% clinicians, 47% clinical support staff, 24% administrative support staff. Survey respondents reported high levels of satisfaction, including 82% reporting improved understanding of the topic, and 68% identifying actions to apply information. Self-rated ability was significantly higher after training for all items ( P  < .0001), including ability to identify patients for MAT and to manage patients receiving MAT. Mean change scores, adjusted for role, were significantly greater for all measures ( P  < .001) in SOuND practices compared to ECHO practices.
CONCLUSIONS


The IT MATTTRs Practice Team Training successfully engaged PCP team members in diverse roles in MAT for OUD training and increased self-efficacy to deliver MAT. Results support the training as a resource for a team-based approach to build rural practices' capacity to deliver MAT.",2020,"Self-rated ability was significantly higher after training for all items ( P  < .0001), including ability to identify patients for MAT and to manage patients receiving MAT.","['441 team members at 42 PCPs were trained, including 22% clinicians, 47% clinical support staff, 24% administrative support staff', 'PCPs in the High Plains Research Network and Colorado Research Network', 'Rural Primary Care Practices']",['team training either in-person or through virtual tele-mentoring'],"['Self-rated ability', 'Mean change scores']","[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",441.0,0.0358636,"Self-rated ability was significantly higher after training for all items ( P  < .0001), including ability to identify patients for MAT and to manage patients receiving MAT.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Zittleman', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Curcija', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Sutter', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Dionisia', 'Initials': 'D', 'LastName': 'de la Cerda', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Nease', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Westfall', 'Affiliation': 'Department of Family Medicine, School of Medicine, University of Colorado, Aurora, CO, USA.'}]",Journal of primary care & community health,['10.1177/2150132720953723']
2529,32909497,Spironolactone in Atrial Fibrillation With Preserved Cardiac Fraction: The IMPRESS-AF Trial.,"Background Patients with permanent atrial fibrillation have poor outcomes, exercise capacity, and quality of life even on optimal anticoagulation. Based on mechanistic and observational data, we tested whether the mineralocorticoid receptor antagonist spironolactone can improve exercise capacity, E/e' ratio, and quality of life in patients with permanent atrial fibrillation and preserved ejection fraction. Methods and Results The double-masked, placebo-controlled IMPRESS-AF (Improved Exercise Tolerance in Heart Failure With Preserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation) trial (NCT02673463) randomized 250 stable patients with permanent atrial fibrillation and preserved left ventricular ejection fraction to spironolactone 25 mg daily or placebo. Patients were followed for 2 years. The primary efficacy outcome was peak oxygen consumption on cardiopulmonary exercise testing at 2 years. Secondary end points included 6-minute walk distance, E/e' ratio, quality of life, and hospital admissions. Spironolactone therapy did not improve peak oxygen consumption at 2 years (14.0 mL/min per kg [SD, 5.4]) compared with placebo (14.5 [5.1], adjusted treatment effect, -0.28; 95% CI, -1.27 to 0.71];  P =0.58). The findings were consistent across all sensitivity analyses. There were no differences in the 6-minute walking distance (adjusted treatment effect, -8.47 m; -31.9 to 14.9;  P =0.48), E/e' ratio (adjusted treatment effect, -0.68; -1.52 to 0.17,  P =0.12), or quality of life ( P =0.74 for EuroQol-5 Dimensions, 5-level version quality of life questionnaire and  P =0.84 for Minnesota Living with Heart Failure). At least 1 hospitalization occurred in 15% of patients in the spironolactone group and 23% in the placebo group ( P =0.15). Estimated glomerular filtration rate was reduced by 6 mL/min in the spironolactone group with <1-unit reduction in controls ( P <0.001). Systolic blood pressure was reduced by 7.2 mm Hg (95% CI, 2.2-12.3) in the spironolactone group versus placebo ( P =0.005). Conclusions Spironolactone therapy does not improve exercise capacity, E/e' ratio, or quality of life in patients with chronic atrial fibrillation and preserved ejection fraction. Registration UTL: https://www.clini​caltr​ial.gov; Unique identifier: NCT02673463. EudraCT number 2014-003702-33.",2020,"Systolic blood pressure was reduced by 7.2 mm Hg (95% CI, 2.2-12.3) in the spironolactone group versus placebo ( P =0.005).","['patients with chronic atrial fibrillation and preserved ejection fraction', 'Heart Failure', ' Patients with permanent atrial fibrillation', 'patients with permanent atrial fibrillation and preserved ejection fraction', 'Atrial Fibrillation With Preserved Cardiac Fraction', '250 stable patients with permanent atrial fibrillation and preserved left ventricular ejection fraction to']","['Spironolactone', 'spironolactone 25\xa0mg daily or placebo', 'mineralocorticoid receptor antagonist spironolactone', 'spironolactone', 'placebo', 'placebo-controlled IMPRESS-AF', 'Spironolactone therapy']","['hospitalization', 'version quality of life questionnaire', 'Estimated glomerular filtration rate', 'exercise capacity, and quality of life', ""exercise capacity, E/e' ratio, or quality of life"", ""6-minute walk distance, E/e' ratio, quality of life, and hospital admissions"", 'peak oxygen consumption', ""exercise capacity, E/e' ratio, and quality of life"", 'peak oxygen consumption on cardiopulmonary exercise testing at 2\xa0years', 'Systolic blood pressure', '6-minute walking distance', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694539', 'cui_str': 'Chronic atrial fibrillation'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2586056', 'cui_str': 'Permanent atrial fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0990353', 'cui_str': 'Spironolactone 25 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",250.0,0.36997,"Systolic blood pressure was reduced by 7.2 mm Hg (95% CI, 2.2-12.3) in the spironolactone group versus placebo ( P =0.005).","[{'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Shantsila', 'Affiliation': 'North Worcestershire VTS St Helens and Knowsley Teaching Hospitals NHS Trust Prescot Merseyside United Kingdom.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Shahid', 'Affiliation': 'Institute of Cardiovascular Sciences University of Birmingham United Kingdom.'}, {'ForeName': 'Yongzhong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Deeks', 'Affiliation': 'Birmingham Clinical Trials Unit Institute of Applied Health Research University of Birmingham United Kingdom.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Calvert', 'Affiliation': 'NIHR Birmingham Biomedical Research Centre University of Birmingham United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': 'Department of Physiology Faculty of Medical and Health Sciences University of Auckland New Zealand.'}, {'ForeName': 'Paulus', 'Initials': 'P', 'LastName': 'Kirchhof', 'Affiliation': 'Institute of Cardiovascular Sciences University of Birmingham United Kingdom.'}, {'ForeName': 'Paramjit S', 'Initials': 'PS', 'LastName': 'Gill', 'Affiliation': 'Academic Unit of Primary Care Warwick Medical School University of Warwick Coventry United Kingdom.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science University of Liverpool and Liverpool Heart & Chest Hospital Liverpool United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.016239']
2530,32909511,Trimetazidine can prevent the occurrence of contrast-induced nephropathy after percutaneous coronary intervention in elderly patients with renal insufficiency.,"BACKGROUND


Contrast-induced nephropathy (CIN) has become a common cause of hospital-acquired acute kidney injury in elderly patients. Trimetazidine (TMZ) is a type of anti-ischemic drug developed in recent years, which can reduce the incidence of CIN. This study aimed to evaluate the efficacy of TMZ in the prevention of contrast-induced nephropathy in elderly patients with renal insufficiency undergoing percutaneous coronary intervention (PCI) and to explore the mechanism of action.
METHODS


A total of 310 elderly patients with renal insufficiency undergoing elective PCI were enrolled and randomly assigned to a control group (n = 155, hydration only) and a TMZ group (n = 155, 20 mg thrice daily orally 24 hours before and 72 hours after PCI). The primary endpoint of the study was the incidence of CIN, which was defined as an increase of 25% or more, or an absolute increase of 0.5 mg/dL or more in serum creatinine from baseline value, at 48 to 72 hours following the exposure to contrast media (CM).
RESULTS


The incidence of CIN was significantly lower in the TMZ group than that in the control group (3.2% vs. 9.7%, p = 0.021). There was no difference regarding the incidence of major adverse events during hospitalization between the TMZ group and control group (1.9% vs. 2.6%, p = 1.000). Binary logistic regression results showed that TMZ was protective factors of CIN (OR = 0.274; 95% CI: 0.089-0.847; p = 0.025).
CONCLUSION


Therefore, we came to the conclusion that prophylactic administration of TMZ can prevent the occurrence of CIN in elderly patients with renal insufficiency undergoing PCI and has a certain protective effect on the renal function of patients. According to the experimental results and the mechanism of TMZ on cardiomyocytes, we speculate that TMZ increases kidney glucose metabolism, reduces fatty acid oxidation, and also has a protective effect on kidney free radical damage and ischemia-reperfusion injury.",2020,"There was no difference regarding the incidence of major adverse events during hospitalization between the TMZ group and control group (1.9% vs. 2.6%, p = 1.000).","['elderly patients with renal insufficiency undergoing PCI', 'elderly patients with renal insufficiency', 'elderly patients', 'group (n\u2009', '310 elderly patients with renal insufficiency undergoing elective PCI', 'elderly patients with renal insufficiency undergoing percutaneous coronary intervention (PCI']","['Trimetazidine', 'TMZ', 'Trimetazidine (TMZ', 'control group (n\u2009=\u2009155, hydration only) and a TMZ', 'Contrast-induced nephropathy (CIN']","['incidence of CIN', 'incidence of major adverse events during hospitalization']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",310.0,0.0679794,"There was no difference regarding the incidence of major adverse events during hospitalization between the TMZ group and control group (1.9% vs. 2.6%, p = 1.000).","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Zhican', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Wenyuan', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Shicheng', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}, {'ForeName': 'Naikuan', 'Initials': 'N', 'LastName': 'Fu', 'Affiliation': 'Tianjin Chest Hospital, Tianjin, China.'}]",Perfusion,['10.1177/0267659120957856']
2531,32909815,Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial.,"OBJECTIVE


The aim of the current study was to introduce and measure the effectiveness of a new 3D-printed nasoalveolar molding (D-NAM) appliance on improving the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair.
DESIGN


A prospective, balanced, randomized, parallel groups, single-blinded, controlled trial.
SETTING


All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt.
PARTICIPANTS


Thirty-four, nonsyndromic infants with UCLP.
INTERVENTIONS


The eligible infants were randomly assigned into either no-treatment (control) or to the new D-NAM groups. In D-NAM group, the maxillary models were 3D scanned into virtual models onto which segmentation and alveolar segments approximation were performed. Approximation movements were divided into 3 models representing 3 activation steps. On each of these models, virtual appliance construction was performed followed by 3D printing of the appliance. Nasal stent was added manually to the appliances of the second and third steps. Horizontal tapes were applied to infants in the D-NAM group only.
MAIN OUTCOMES MEASURES


A Blinded assessors carried all the MADs measurements virtually on digital models collected at the beginning (T1) and after (T2) treatment.
RESULTS


Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group.
CONCLUSIONS


The introduced D-NAM/3D-printed appliance is a simple and efficient technique to improve the MADs in infants with UCLP before surgical lip repair.",2020,"Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group.
","['Thirty-four, nonsyndromic infants with UCLP', 'Unilateral Cleft Lip and Palate Infants', 'All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt', 'infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair', 'infants with UCLP before surgical lip repair']","['no-treatment (control) or to the new D-NAM', 'Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM', 'new 3D-printed nasoalveolar molding (D-NAM) appliance']",['measured MADs'],"[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0158646', 'cui_str': 'Cleft palate with cleft lip'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0192038', 'cui_str': 'Repair of lip'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027366', 'cui_str': 'Namibia'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0426103', 'cui_str': 'Fetal head molding'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0305097,"Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group.
","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abd El-Ghafour', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mamdouh A', 'Initials': 'MA', 'LastName': 'Aboulhassan', 'Affiliation': 'Department of Pediatric Plastic Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mona M Salah', 'Initials': 'MMS', 'LastName': 'Fayed', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr Ragab', 'Initials': 'AR', 'LastName': 'El-Beialy', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Faten Hussein Kamel', 'Initials': 'FHK', 'LastName': 'Eid', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Seif El-Din', 'Initials': 'SE', 'LastName': 'Hegab', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Gendi', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dawlat', 'Initials': 'D', 'LastName': 'Emara', 'Affiliation': 'Department of Plastic Surgery, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665620954321']
2532,32909826,Maturity Progression of the Entire Anterior Cruciate Ligament Graft of Insertion-Preserved Hamstring Tendons by 5 Years: A Prospective Randomized Controlled Study Based on Magnetic Resonance Imaging Evaluation.,"BACKGROUND


It has been reported that insertion-preserved hamstring tendon autografts (IP-HT) have better maturity than free hamstring tendon autografts (FHT) at 2 years after anterior cruciate ligament reconstruction (ACLR); however, whether insertion preservation improves the maturity of the entire autograft and clinical outcomes at 5 years after ACLR is still unclear.
PURPOSE


To investigate the clinical outcomes and maturity of different segments using insertion-preserved and free hamstring tendon autografts up to 5 years after ACLR.
STUDY DESIGN


Randomized controlled trial; Level of evidence, 2.
METHODS


45 patients who underwent isolated ACLR with hamstring tendon autografts were enrolled and randomized into 2 groups. The study group had ACLR with IP-HT, whereas the control group had ACLR with FHT. The International Knee Documentation Committee and Tegner scores, Lysholm activity score, and KT-1000 arthrometer measurements were evaluated preoperatively and at 6, 12, 24, and 60 months postoperatively. Three-dimensional-reconstruction MRI examinations were performed at 6, 12, 24, and 60 months to evaluate the signal/noise quotient (SNQ) values of femoral tunnel graft, intra-articular graft, and tibial tunnel graft.
RESULTS


At 60 months, the SNQ values of the intra-articular and tunnel sections for the grafts in both groups showed no difference; the clinical outcomes were improved compared with before surgery ( P  < .001) and were similar in both groups. In the early stage, all graft segments in the IP-HT group had lower SNQ values than those of the FHT group. At 6 months, the entire graft in the FHT group and the femoral tunnel section in the IP-HT group had the maximum SNQ values, whereas the femoral tunnel graft had the highest SNQ value compared with intra-articular and tibial tunnel graft in each group. SNQ values of the intra-articular and tibial tunnel graft in the IP-HT group had no significant change within 60 months.
CONCLUSION


All patients had similar clinical outcomes and graft maturity at 60 months postoperatively. The SNQ values and progressions varied at different graft sites and were highest for the femoral tunnel graft. All significantly changing SNQ values reached the maximum value at 6 months. Compared with FHT autograft, the graft maturity of IP-HT autograft recovered earlier and appeared more stable within the 60-month follow-up; however, no significant association was found between graft maturity and clinical scores.",2020,"SNQ values of the intra-articular and tibial tunnel graft in the IP-HT group had no significant change within 60 months.
","['Maturity Progression of the Entire Anterior Cruciate Ligament Graft of Insertion-Preserved Hamstring Tendons by 5 Years', '45 patients who underwent isolated ACLR with hamstring tendon autografts']","['insertion-preserved and free hamstring tendon autografts', 'hamstring tendon autografts (FHT', 'FHT autograft', 'Magnetic Resonance Imaging Evaluation', 'FHT', 'ACLR with IP-HT', 'insertion-preserved hamstring tendon autografts (IP-HT']","['SNQ values', 'clinical outcomes', 'International Knee Documentation Committee and Tegner scores, Lysholm activity score, and KT-1000 arthrometer measurements', 'SNQ values of the intra-articular and tunnel sections', 'maximum SNQ values', 'graft maturity and clinical scores', 'ACLR with FHT', 'SNQ values of the intra-articular and tibial tunnel graft', 'signal/noise quotient (SNQ) values of femoral tunnel graft, intra-articular graft, and tibial tunnel graft', 'femoral tunnel section']","[{'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1748452', 'cui_str': 'Entire anterior cruciate ligament of knee joint'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0183894', 'cui_str': 'Arthrometer'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}]",45.0,0.0372722,"SNQ values of the intra-articular and tibial tunnel graft in the IP-HT group had no significant change within 60 months.
","[{'ForeName': 'Yuhan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Qingyan', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Biology, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yaying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiwu', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Sports Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",The American journal of sports medicine,['10.1177/0363546520951507']
2533,32909887,'You are Okay': Effects of a support and educational program for children with mild intellectual disability and their parents with mental health concerns.,"BACKGROUND


Children with mild intellectual disabilities and emotional and behavioural problems whose parents have mental health concerns are at an increased risk of developing problems themselves. This study analysed the effectiveness of the 'You are Okay'-program aimed to support these children and parents and to reduce the risk of problem development in children.
METHOD


A quasi-experimental design was used to compare the experimental group ('care as usual' and 'You are Okay') with the control group ('care as usual') on the main outcome of emotional and behavioural problems and proposed intermediate outcomes.
RESULTS


Children in the experimental group reported a significant medium to large decrease in emotional and behavioural problems compared to the control group. The effects on the intermediate outcomes were non-significant.
CONCLUSIONS


This specific study population comprising a vulnerable group of children seems to benefit from this specially adapted 'You are Okay'-program. More research is necessary to draw further conclusions.",2020,"RESULTS


Children in the experimental group reported a significant medium to large decrease in emotional and behavioural problems compared to the control group.","['Children with mild intellectual disabilities', 'children with mild intellectual disability and their parents with mental health concerns', 'children']","['support and educational program', ""control group ('care as usual""]",['emotional and behavioural problems'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026106', 'cui_str': 'Mild intellectual disability'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.0457915,"RESULTS


Children in the experimental group reported a significant medium to large decrease in emotional and behavioural problems compared to the control group.","[{'ForeName': 'Ivon', 'Initials': 'I', 'LastName': 'Riemersma', 'Affiliation': 'Pluryn Research & Development, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Van Santvoort', 'Affiliation': 'Pluryn Research & Development, The Netherlands.'}, {'ForeName': 'Ktm', 'Initials': 'K', 'LastName': 'Van Doesum', 'Affiliation': '6029Radboud University Nijmegen, The Netherlands; Impluz Team Prevention, Dimence Groep, The Netherlands.'}, {'ForeName': 'Cmh', 'Initials': 'C', 'LastName': 'Hosman', 'Affiliation': '6029Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'Jmam', 'Initials': 'J', 'LastName': 'Janssens', 'Affiliation': '6029Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'Rap', 'Initials': 'R', 'LastName': 'Van der Zanden', 'Affiliation': '26063Trimbos-Institute, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Otten', 'Affiliation': 'Pluryn Research & Development, The Netherlands; Radboud University Nijmegen, The Netherlands; Arizona State University, USA.'}]",Journal of intellectual disabilities : JOID,['10.1177/1744629520953765']
2534,32909921,CPAP combined with oral appliance therapy reduces CPAP requirements and pharyngeal pressure swings in obstructive sleep apnea.,"STUDY OBJECTIVES


Oral appliance (OA) therapy is the leading alternative to continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA). It is well tolerated compared to CPAP. However, ≥50% of patients using OA therapy have incomplete resolution of their OSA. Combination therapy with CPAP and oral appliance (CPAP+OA) is a potential alternative for incomplete responders to OA therapy. This study aimed to determine the extent to which combination therapy reduces therapeutic CPAP requirements using gold standard physiological methodology in those who have an incomplete response to OA therapy alone.
METHODS


16 incomplete responders (residual AHI> 10events/h) to a novel OA with a built-in oral airway were recruited (3F:13M, aged 31-65 years, BMI: 22-38kg/m 2 , residual AHI range 13-63events/h). Participants were fitted with a nasal mask, pneumotachograph, epiglottic pressure catheter and standard polysomnography equipment. CPAP titrations were performed during NREM supine sleep in each participant during 3 conditions (order randomized): 1) CPAP only, 2) CPAP+OA(oral airway open), and 3) CPAP+OA(oral airway closed).
RESULTS


OSA was resolved at pressures of 4±2 and 5±2cmH 2 O during CPAP+OA (oral airway open) and CPAP+OA (oral airway closed) conditions versus 8±2cmH 2 O during CPAP only (P<0.01). Negative epiglottic pressure swings in oral airway open and closed conditions were normalized to CPAP only levels (-2.5[-3.7,-2.6] vs. -2.3[-3.2,-2.4]vs. -2.1[-2.7,-2.3]cmH 2 O).
CONCLUSIONS


Combined CPAP and OA therapy reduces therapeutic CPAP requirements by 35-45% and minimizes epiglottic pressure swings. This combination may be a therapeutic alternative for patients with incomplete responses to OA therapy alone and those who cannot tolerate high CPAP levels.",2020,"Negative epiglottic pressure swings in oral airway open and closed conditions were normalized to CPAP only levels (-2.5[-3.7,-2.6] vs. -2.3[-3.2,-2.4]vs.","['Oral appliance (OA', ' 10events/h) to a novel OA with a built-in oral airway were recruited (3F:13M, aged 31-65 years, BMI: 22-38kg/m 2 , residual AHI range 13-63events/h', 'those who have an incomplete response to OA therapy alone', 'obstructive sleep apnea', '16 incomplete responders (residual AHI', 'obstructive sleep apnea (OSA']","['CPAP and OA therapy', 'CPAP combined with oral appliance therapy', 'OA therapy', 'CPAP and oral appliance (CPAP+OA', 'nasal mask, pneumotachograph, epiglottic pressure catheter and standard polysomnography equipment']","['incomplete resolution of their OSA', 'Negative epiglottic pressure swings', 'therapeutic CPAP requirements', 'OSA', 'CPAP requirements and pharyngeal pressure swings']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150694', 'cui_str': 'Oropharyngeal airway device'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0182334', 'cui_str': 'Pneumotachograph'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0014540', 'cui_str': 'Epiglottis structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}]",,0.0155132,"Negative epiglottic pressure swings in oral airway open and closed conditions were normalized to CPAP only levels (-2.5[-3.7,-2.6] vs. -2.3[-3.2,-2.4]vs.","[{'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Tong', 'Affiliation': 'Neuroscience Research Australia, Australia.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Tran', 'Affiliation': 'Adelaide Institute for Sleep Health, Flinders University, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ricciardiello', 'Affiliation': 'Neuroscience Research Australia, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Donegan', 'Affiliation': 'Neuroscience Research Australia, Australia.'}, {'ForeName': 'Alan K I', 'Initials': 'AKI', 'LastName': 'Chiang', 'Affiliation': 'Neuroscience Research Australia, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Szollosi', 'Affiliation': 'The Prince Charles Hospital, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Amatoury', 'Affiliation': 'Maroun Semaan Faculty of Engineering and Architecture, American University of Beirut, Lebanon.'}, {'ForeName': 'Jayne C', 'Initials': 'JC', 'LastName': 'Carberry', 'Affiliation': 'Adelaide Institute for Sleep Health (AISH), Flinders University, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Flinders University.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00393.2020']
2535,32909954,The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial.,"BACKGROUND


Less than one-third of women gain an appropriate amount of weight during pregnancy, which can influence the long-term health of both the mother and the child. Economically disadvantaged women are the most vulnerable to maternal obesity, excessive weight gain during pregnancy, and poor birth outcomes. Effective and scalable health care strategies to promote healthy weight gain during pregnancy specifically tailored for these women are lacking.
OBJECTIVE


This paper presents the design and protocol of a biphasic, community-based eHealth trial, SmartMoms in WIC, to increase the adherence to healthy gestational weight gain (GWG) recommendations in low-income mothers receiving women, infant, and children (WIC) benefits.
METHODS


Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits. The health curriculum, the format of delivery, and incentive strategies were adapted to be culturally relevant and at an appropriate level of health literacy. Phase 2 included a pragmatic randomized controlled trial across the 9 health care regions in Louisiana with the goal of enrolling 432 women. The SmartMoms in WIC intervention is an intensive 24-week behavioral intervention, which includes nutrition education and exercise strategies, and provides the technology to assist with weight management, delivered through a professionally produced website application.
RESULTS


Phase 1 of this trial was completed in July 2019, and recruitment for phase 2 began immediately thereafter. All data are anticipated to be collected by Spring 2023.
CONCLUSIONS


The SmartMoms in WIC curriculum was methodically developed using feedback from community-based peer advisory groups to create a culturally relevant, mobile behavioral intervention for mothers receiving WIC benefits. The randomized clinical trial is underway to test the effectiveness of a sustainable eHealth program on the incidence rates of appropriate GWG. SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04028843; https://clinicaltrials.gov/ct2/show/NCT04028843.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18211.",2020,"SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
","['Low-Income Women', '9 health care regions in Louisiana with the goal of enrolling 432 women', 'Phase 1 of the trial included using feedback from WIC mothers and staff and participants from 2 community peer advisory groups to adapt an existing eHealth gestational weight management intervention to meet the needs of women receiving WIC benefits']","['sustainable eHealth program', 'Pragmatic and Scalable eHealth Intervention']","['healthy weight gain', 'Gestational Weight Gain', 'healthy gestational weight gain (GWG) recommendations']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0425006', 'cui_str': 'Child benefit'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",432.0,0.16195,"SmartMoms in WIC may be able to offer an innovative, cost-effective, and scalable solution for GWG management in women served by WIC.
","[{'ForeName': 'Emily W', 'Initials': 'EW', 'LastName': 'Flanagan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Abby D', 'Initials': 'AD', 'LastName': 'Altazan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Comardelle', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'L Anne', 'Initials': 'LA', 'LastName': 'Gilmore', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'St Romain', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Hardee', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Renee S', 'Initials': 'RS', 'LastName': 'Puyau', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Christy L', 'Initials': 'CL', 'LastName': 'Mayet', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'S Ariel', 'Initials': 'SA', 'LastName': 'Barlow', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Sarah Surber', 'Initials': 'SS', 'LastName': 'Bounds', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Kelsey N', 'Initials': 'KN', 'LastName': 'Olson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Betty M', 'Initials': 'BM', 'LastName': 'Kennedy', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Hsia', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, United States.'}]",JMIR research protocols,['10.2196/18211']
2536,32910028,Surgical Start Time Is Not Predictive of Microdiscectomy Outcomes.,"STUDY DESIGN


Retrospective analysis of clinical data from a single institution.
OBJECTIVE


The objective of this study was to assess the time of surgery as a possible predictor for outcomes, length of stay, and cost following microdiscectomy.
SUMMARY OF BACKGROUND DATA


The volume of microdiscectomy procedures has increased year over year, heightening interest in surgical outcomes. Previous investigations have demonstrated an association between time of procedures and clinical outcomes in various surgeries, however, no study has evaluated its influence on microdiscectomy.
METHODS


Demographic and outcome variables were collected from all patients that underwent a nonemergent microdiscectomy between 2008 and 2016. Patients were divided into 2 cohorts: those receiving surgery before 2 PM were assigned to the early group and those with procedures beginning after 2 PM were assigned to the late group. Outcomes and patient-level characteristics were compared using bivariate, multivariable logistic, and linear regression models. Adjusted length of stay and cost were coprimary outcomes. Secondary outcomes included operative complications, nonhome discharge, postoperative emergency department visits, or readmission rates.
RESULTS


Of the 1261 consecutive patients who met the inclusion criteria, 792 were assigned to the late group and 469 were assigned to the early group. There were no significant differences in demographics or baseline characteristics between the 2 cohorts. In the unadjusted analysis, mean length of stay was 1.80 (SD=1.82) days for the early group and 2.00 (SD=1.70) days for the late group (P=0.054). Mean direct cost for the early cohort was $5088 (SD=$4212) and $4986 (SD=$2988) for the late cohort (P=0.65). There was no difference in adjusted length of stay or direct cost. No statistically significant differences were found in operative complications, nonhome discharge, postoperative emergency department visits, or readmission rates between the 2 cohorts.
CONCLUSION


The study findings suggest that early compared with late surgery is not significantly predictive of surgical outcomes following microdiscectomy.",2020,"No statistically significant differences were found in operative complications, nonhome discharge, postoperative emergency department visits, or readmission rates between the 2 cohorts.
","['1261 consecutive patients who met the inclusion criteria', 'patients that underwent a nonemergent microdiscectomy between 2008 and 2016']",[],"['Mean direct cost', 'adjusted length of stay or direct cost', 'operative complications, nonhome discharge, postoperative emergency department visits, or readmission rates', 'Adjusted length of stay and cost', 'mean length of stay', 'outcomes, length of stay, and cost following microdiscectomy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0457629', 'cui_str': 'Lumbar microdiscectomy'}]",1261.0,0.0711663,"No statistically significant differences were found in operative complications, nonhome discharge, postoperative emergency department visits, or readmission rates between the 2 cohorts.
","[{'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Maron', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Dan', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Gal', 'Affiliation': 'Anesthesia, Perioperative and Pain Medicine, Mount Sinai Hospital, New York, NY.'}, {'ForeName': 'Sean N', 'Initials': 'SN', 'LastName': 'Neifert', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Martini', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Colin D', 'Initials': 'CD', 'LastName': 'Lamb', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Genadry', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Rothrock', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Steinberger', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Rasouli', 'Affiliation': 'Departments of Neurosurgery.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Caridi', 'Affiliation': 'Departments of Neurosurgery.'}]",Clinical spine surgery,['10.1097/BSD.0000000000001063']
2537,32910030,Comparison of Fractional Picosecond 1064-nm Laser and Fractional Carbon Dioxide Laser for Treating Atrophic Acne Scars: A Randomized Split-Face Trial.,"BACKGROUND


To date, no studies have compared the fractional picosecond 1064-nm laser (FxPico) and fractional carbon dioxide laser (FxCO2) for the treatment of acne scars.
OBJECTIVE


To compare the efficacy and safety between FxPico and FxCO2 for treating facial atrophic acne scars.
MATERIALS AND METHODS


Twenty-five Asian patients with mild to moderate atrophic acne scars underwent single sessions of randomized split-face treatment with FxPico and FxCO2. Clinical efficacy was assessed by photographs, skin imaging analysis, and patient satisfaction. The adverse events were recorded on every visit. Skin biopsies were performed immediately and 3 months after treatment.
RESULTS


The physician improvement scores for skin texture and atrophy significantly increased on the FxPico sides, but no significant difference was observed between FxPico and FxCO2. Skin imaging also showed significant improvement on both sides for scar volume. Postinflammatory hyperpigmentation (PIH) was not reported on FxPico sides, whereas 6 patients (24%) experienced mild PIH on FxCO2 sides. Immediate post-FxPico skin biopsy revealed laser-induced optical breakdown with photoacoustic columns. Collagen and elastic fibers increased at 3 months after both treatments.
CONCLUSION


FxPico was as effective as FxCO2 in treating atrophic acne scars, correlating with evidence of tissue remodeling with more safety profiles.",2020,"The physician improvement scores for skin texture and atrophy significantly increased on the FxPico sides, but no significant difference was observed between FxPico and FxCO2.","['Atrophic Acne Scars', 'facial atrophic acne scars', 'Twenty-five Asian patients with mild to moderate atrophic acne scars underwent']","['FxPico and FxCO2', 'single sessions of randomized split-face treatment with FxPico and FxCO2', 'FxPico', 'fractional picosecond 1064-nm laser (FxPico) and fractional carbon dioxide laser (FxCO2', 'Fractional Picosecond 1064-nm Laser and Fractional Carbon Dioxide Laser']","['Skin biopsies', 'Collagen and elastic fibers', 'efficacy and safety', 'Postinflammatory hyperpigmentation (PIH', 'adverse events', 'skin texture and atrophy', 'Clinical efficacy']","[{'cui': 'C1274728', 'cui_str': 'Atrophic acne scar'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0150866', 'cui_str': 'Biopsy of skin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0230899', 'cui_str': 'Elastic fiber'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333616', 'cui_str': 'Postinflammatory hyperpigmentation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",25.0,0.0327362,"The physician improvement scores for skin texture and atrophy significantly increased on the FxPico sides, but no significant difference was observed between FxPico and FxCO2.","[{'ForeName': 'Punyaphat', 'Initials': 'P', 'LastName': 'Sirithanabadeekul', 'Affiliation': 'Department of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand.'}, {'ForeName': 'Bheeratida', 'Initials': 'B', 'LastName': 'Rattakul', 'Affiliation': 'Samitivej Esthetic Institute, Samitivej Sukhumvit Hospital, Bangkok, Thailand.'}, {'ForeName': 'Nalinee', 'Initials': 'N', 'LastName': 'Sutthipisal', 'Affiliation': 'Samitivej Esthetic Institute, Samitivej Sukhumvit Hospital, Bangkok, Thailand.'}, {'ForeName': 'Wilai', 'Initials': 'W', 'LastName': 'Thanasarnaksorn', 'Affiliation': 'Samitivej Esthetic Institute, Samitivej Sukhumvit Hospital, Bangkok, Thailand.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002572']
2538,32910077,Pelvic Organ Prolapse Severity and Genital Hiatus Size With Long-Term Pessary Use.,"OBJECTIVES


To evaluate the association between pessary use more than 1 year and change in prolapse severity.
METHODS


This is a secondary analysis of a previously published randomized controlled trial of women undergoing office management of pessaries for management of symptomatic pelvic organ prolapse and incontinence. Primary outcome was change in pelvic organ prolapse quantification measurement genital hiatus (GH). Secondary outcomes included change in prolapse stage, type of pessary, size of pessary, number of pessary changes, and duration of use. Baseline data were collected from the earliest documented examination within the hospital record before pessary placement and compared with their final study visit. Demographics were analyzed using descriptive statistics. Student t test and Mann-Whitney tests were used for categorical comparisons. Pearson and Spearman correlation coefficients were used to evaluate change over time.
RESULTS


The cohort was 132 predominantly non-Hispanic White (75%) women with symptomatic prolapse >stage 2 (70.5%). All were postmenopausal. Median duration of pessary use was 39.5 months (interquartile range, 17-64.5 months). Genital hiatus (P = 0.014) and prolapse stage (P = 0.001) decreased as duration of pessary use increased. Those with baseline stages ≥3 had a significant decrease in GH as duration of pessary use increased compared with stages <3 (-0.5 cm vs 0 cm, P < 0.001). There was no difference in change in GH when comparing women with baseline GH less than 3 to 3 cm or greater.
CONCLUSIONS


Pessary use by women with pelvic organ prolapse causes a change in vaginal anatomy over time as seen by decreasing stage and point GH.",2020,Genital hiatus (P = 0.014) and prolapse stage (P = 0.001) decreased as duration of pessary use increased.,"['The cohort was 132 predominantly non-Hispanic White (75%) women with symptomatic prolapse >stage 2 (70.5', 'women with pelvic organ prolapse', 'women undergoing office management of pessaries for management of symptomatic pelvic organ prolapse and incontinence']",[],"['Median duration of pessary use', 'Genital hiatus', 'change in GH', 'change in prolapse stage, type of pessary, size of pessary, number of pessary changes, and duration of use', 'pelvic organ prolapse quantification measurement genital hiatus (GH', 'prolapse stage', 'GH as duration of pessary use']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1097368', 'cui_str': 'AM132'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0028894', 'cui_str': 'Office Management'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",132.0,0.242384,Genital hiatus (P = 0.014) and prolapse stage (P = 0.001) decreased as duration of pessary use increased.,"[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Boyd', 'Affiliation': ""From the Female Pelvic Medicine and Reconstructive Surgery, Department of Women's Health, Hartford Hospital.""}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Subramanian', 'Affiliation': ""From the Female Pelvic Medicine and Reconstructive Surgery, Department of Women's Health, Hartford Hospital.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Propst', 'Affiliation': ""From the Female Pelvic Medicine and Reconstructive Surgery, Department of Women's Health, Hartford Hospital.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Research Administration, Hartford Healthcare, Hartford, CT.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tulikangas', 'Affiliation': ""From the Female Pelvic Medicine and Reconstructive Surgery, Department of Women's Health, Hartford Hospital.""}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000937']
2539,32910141,"A randomized, placebo-controlled, double-blind pilot study of single-dose humanized anti-IL5 antibody (reslizumab) for the reduction of eosinophilia following diethylcarbamazine treatment of Loa loa infection.","BACKGROUND


Diethylcarbamazine citrate (DEC) treatment of loiasis is complicated by adverse reactions that are correlated with the number of circulating microfilariae (mf). The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation.
METHODS


To explore the role of IL-5 driven eosinophilia in post-DEC reactions, 8 adults with confirmed loiasis and &5000 mf/mL blood were enrolled in a randomized, double-blind, placebo-controlled trial of the humanized anti-IL-5 antibody, reslizumab, (1.0 mg/kg IV) administered 3 to 7 days prior to initiation of DEC treatment (9 mg/kg/day for 21 days). The primary endpoint was the reduction in absolute eosinophil count (AEC) during the first week of DEC treatment.
RESULTS


Baseline characteristics were comparable between the two groups. Single dose reslizumab lowered the AEC by 77% prior to initiation of DEC therapy (vs. 12% in the placebo group, p&0.05). More importantly, AEC remained below baseline in the first week of DEC treatment in all subjects who received reslizumab and in none of the placebo subjects. Mf clearance occurred within 2 days of initiation of DEC in all 7 mf-positive subjects. Mild to moderate adverse events were seen in all 8 subjects and were not significantly different between the groups.
CONCLUSIONS


In summary, although reslizumab was able to blunt peripheral eosinophilia post-DEC treatment in subjects with loiasis and had no effect on microfilarial clearance, the reduction in AEC appeared to have been insufficient to prevent post-treatment AEs.",2020,"Mild to moderate adverse events were seen in all 8 subjects and were not significantly different between the groups.
","['Loa loa infection', '8 adults with confirmed loiasis and &5000 mf/mL blood']","['single-dose humanized anti-IL5 antibody (reslizumab', 'reslizumab', 'Diethylcarbamazine citrate (DEC', 'diethylcarbamazine', 'humanized anti-IL-5 antibody, reslizumab', 'placebo']","['AEC', 'Mf clearance', 'Mild to moderate adverse events', 'microfilarial clearance', 'reduction in absolute eosinophil count (AEC']","[{'cui': 'C0023968', 'cui_str': 'Infection by Loa loa'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0025980', 'cui_str': 'Superfamily Filarioidea microfilaria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0700531', 'cui_str': 'Diethylcarbamazine Citrate'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",8.0,0.23946,"Mild to moderate adverse events were seen in all 8 subjects and were not significantly different between the groups.
","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Legrand', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Herrick', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Makiya', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Reagan', 'Initials': 'R', 'LastName': 'Thompson', 'Affiliation': 'University of Virginia Family Medicine, Charlottesville, VA.'}, {'ForeName': 'Shakuntala', 'Initials': 'S', 'LastName': 'Rampertaap', 'Affiliation': 'Department of Laboratory Medicine, Warren Magnusson Clinical Center, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stoddard', 'Affiliation': 'Department of Laboratory Medicine, Warren Magnusson Clinical Center, NIH, Bethesda, MD, USA.'}, {'ForeName': 'JeanAnne', 'Initials': 'J', 'LastName': 'Ware', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Fay', 'Affiliation': 'Biostatistics Research Branch, DCR, NIAID, Rockville, MD.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Holland-Thomas', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Nutman', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Klion', 'Affiliation': 'Laboratory of Parasitic Diseases, NIAID, Bethesda, MD, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1365']
2540,32910152,Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials.,"OBJECTIVE


In the ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials, the adjuvanted recombinant zoster vaccine (RZV) demonstrated ≥90% efficacy in preventing herpes zoster (HZ) in all age groups ≥50 years. Given the increased HZ risk associated with certain underlying autoimmune diseases or their treatment regimes, we conducted a post hoc analysis of RZV's efficacy against HZ and safety profile [specifically, the occurrence of serious adverse events (SAEs)] in ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies.
METHODS


Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years were randomized to receive two doses of RZV or placebo 2 months apart. In this subgroup analysis of participants with at least one pIMD at enrolment, the efficacy was calculated for two-dose recipients who did not develop confirmed HZ before 30 days post-dose 2. SAE occurrence was evaluated for all participants who received at least one dose.
RESULTS


Of the 14 645 RZV and 14 660 placebo recipients from the ZOE-50/70 studies, 983 and 960, respectively, reported at least one pre-existing pIMD at enrolment and were included in these analyses. The most frequent pre-existing conditions were psoriasis, spondyloarthropathy and RA. Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group. SAEs and fatal SAEs were similar between RZV and placebo recipients.
CONCLUSION


In ZOE-50/70 participants with pre-existing pIMDs, RZV was highly efficacious against HZ and SAE incidence was similar between RZV and placebo recipients.
TRIAL REGISTRATION


ClinicalTrials.gov, https://clinicaltrials.gov, NCT01165177 (ZOE-50), NCT01165229 (ZOE-70).",2020,"Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group.","['adults with pre-existing potential immune-mediated diseases', 'herpes zoster (HZ) in all age groups ≥50\u2009years', 'ZOE-50/70 participants who reported pre-existing potential immune-mediated diseases (pIMDs) at enrolment and were not on immunosuppressive therapies', 'Adults aged ≥50 (ZOE-50) and ≥70 (ZOE-70) years']","['RZV or placebo', 'adjuvanted recombinant zoster vaccine', 'recombinant zoster vaccine (RZV']","['SAEs and fatal SAEs', 'SAE occurrence', 'Efficacy against HZ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}]",,0.563023,"Efficacy against HZ was 90.5% (95% CI: 73.5, 97.5%) overall with the lowest being 84.4% (95% CI: 30.8, 98.3%) in the 70-79-year-old age group.","[{'ForeName': 'Alemnew F', 'Initials': 'AF', 'LastName': 'Dagnew', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Rausch', 'Affiliation': 'GSK, Philadelphia, PA, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Toufik', 'Initials': 'T', 'LastName': 'Zahaf', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, Rockville, MD, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa424']
2541,32910179,Effect of Recombinant Human Granulocyte Colony-Stimulating Factor for Patients With Coronavirus Disease 2019 (COVID-19) and Lymphopenia: A Randomized Clinical Trial.,"Importance


Lymphopenia is common and correlates with poor clinical outcomes in patients with coronavirus disease 2019 (COVID-19).
Objective


To determine whether a therapy that increases peripheral blood leukocyte and lymphocyte cell counts leads to clinical improvement in patients with COVID-19.
Design, Setting and Participants


Between February 18 and April 10, 2020, we conducted an open-label, multicenter, randomized clinical trial at 3 participating centers in China. The main eligibility criteria were pneumonia, a blood lymphocyte cell count of 800 per μL (to convert to ×109/L, multiply by 0.001) or lower, and no comorbidities. Severe acute respiratory syndrome coronavirus 2 infection was confirmed with reverse-transcription polymerase chain reaction testing.
Exposures


Usual care alone, or usual care plus 3 doses of recombinant human granulocyte colony-stimulating factor (rhG-CSF, 5 μg/kg, subcutaneously at days 0-2).
Main Outcomes and Measures


The primary end point was the time from randomization to improvement of at least 1 point on a 7-category disease severity score.
Results


Of 200 participants, 112 (56%) were men and the median (interquartile range [IQR]) age was 45 (40-55) years. There was random assignment of 100 patients (50%) to the rhG-CSF group and 100 (50%) to the usual care group. Time to clinical improvement was similar between groups (rhG-CSF group median of 12 days (IQR, 10-16 days) vs usual care group median of 13 days (IQR, 11-17 days); hazard ratio, 1.28; 95% CI, 0.95-1.71; P = .06). For secondary end points, the proportion of patients progressing to acute respiratory distress syndrome, sepsis, or septic shock was lower in the rhG-CSF group (rhG-CSF group, 2% vs usual care group, 15%; difference, -13%; 95%CI, -21.4% to -5.4%). At 21 days, 2 patients (2%) had died in the rhG-CSF group compared with 10 patients (10%) in the usual care group (hazard ratio, 0.19; 95%CI, 0.04-0.88). At day 5, the lymphocyte cell count was higher in the rhG-CSF group (rhG-CSF group median of 1050/μL vs usual care group median of 620/μL; Hodges-Lehmann estimate of the difference in medians, 440; 95% CI, 380-490). Serious adverse events, such as sepsis or septic shock, respiratory failure, and acute respiratory distress syndrome, occurred in 29 patients (14.5%) in the rhG-CSF group and 42 patients (21%) in the usual care group.
Conclusion and Relevance


In preliminary findings from a randomized clinical trial, rhG-CSF treatment for patients with COVID-19 with lymphopenia but no comorbidities did not accelerate clinical improvement, but the number of patients developing critical illness or dying may have been reduced. Larger studies that include a broader range of patients with COVID-19 should be conducted.
Trial Registration


Chinese Clinical Trial Registry: ChiCTR2000030007.",2020,"At day 5, the lymphocyte cell count was higher in the rhG-CSF group (rhG-CSF group median of 1050/μL vs usual care group median of 620/μL; Hodges-Lehmann estimate of the difference in medians, 440; 95% CI, 380-490).","['patients with coronavirus disease 2019 (COVID-19', 'patients with COVID-19', '200 participants, 112 (56%) were men and the median (interquartile range [IQR]) age was 45 (40-55) years', 'Patients With Coronavirus Disease 2019 (COVID-19) and Lymphopenia', '3 participating centers in China', 'patients with COVID-19 with lymphopenia', '100 patients (50%) to the rhG-CSF group and 100 (50%) to the usual care group', 'Participants\n\n\nBetween February 18 and April 10, 2020']","['Exposures\n\n\nUsual care alone, or usual care plus 3 doses of recombinant human granulocyte colony-stimulating factor (rhG-CSF', 'Recombinant Human Granulocyte Colony-Stimulating Factor']","['Serious adverse events, such as sepsis or septic shock, respiratory failure, and acute respiratory distress syndrome', 'lymphocyte cell count', 'blood lymphocyte cell count', 'proportion of patients progressing to acute respiratory distress syndrome, sepsis, or septic shock', 'peripheral blood leukocyte and lymphocyte cell counts', 'time from randomization to improvement of at least 1 point on a 7-category disease severity score', 'Time to clinical improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.213518,"At day 5, the lymphocyte cell count was higher in the rhG-CSF group (rhG-CSF group median of 1050/μL vs usual care group median of 620/μL; Hodges-Lehmann estimate of the difference in medians, 440; 95% CI, 380-490).","[{'ForeName': 'Lin-Ling', 'Initials': 'LL', 'LastName': 'Cheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Chong-Yang', 'Initials': 'CY', 'LastName': 'Duan', 'Affiliation': 'State Key Laboratory of Organ Failure Research, National Clinical Research Center for Kidney Disease, Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Nuo-Fu', 'Initials': 'NF', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Chun-Liang', 'Initials': 'CL', 'LastName': 'Lei', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Ai-Lan', 'Initials': 'AL', 'LastName': 'Chen', 'Affiliation': 'Medical Department, Hankou Hospital of Wuhan City, Wuhan, China.'}, {'ForeName': 'Shi-Yue', 'Initials': 'SY', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhuo', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xi-Long', 'Initials': 'XL', 'LastName': 'Deng', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Fan-Jun', 'Initials': 'FJ', 'LastName': 'Cheng', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Jian-Heng', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jia-Xing', 'Initials': 'JX', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Ying-Xian', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xiao-Xiong', 'Initials': 'XX', 'LastName': 'Wu', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Peng', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Guang-Ming', 'Initials': 'GM', 'LastName': 'Xiao', 'Affiliation': ""Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Ping-Yan', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Organ Failure Research, National Clinical Research Center for Kidney Disease, Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Haematology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zi-Feng', 'Initials': 'ZF', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jin-Cun', 'Initials': 'JC', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.5503']
2542,32910418,"Correction to: The Effect of Rifampin on the Pharmacokinetics and Safety of Lorlatinib: Results of a Phase One, Open-Label, Crossover Study in Healthy Participants.","In the original article, the reference 4 has been published and cited incorrectly.",2020,"In the original article, the reference 4 has been published and cited incorrectly.",['Healthy Participants'],"['Rifampin', 'Lorlatinib']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C4080091', 'cui_str': 'Lorlatinib'}]",[],,0.0167416,"In the original article, the reference 4 has been published and cited incorrectly.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Global Product Development, Pfizer Oncology, New York, NY, USA. joseph.chen@pfizer.com.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.'}, {'ForeName': 'Sylvester', 'Initials': 'S', 'LastName': 'Pawlak', 'Affiliation': 'Global Product Development, Pfizer Inc., New Haven, CT, USA.'}, {'ForeName': 'Leonard P', 'Initials': 'LP', 'LastName': 'James', 'Affiliation': 'Global Product Development, Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Peltz', 'Affiliation': 'Safety Surveillance and Risk Management, Pfizer Oncology, Groton, CT, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ginman', 'Affiliation': 'Global Product Development, Pfizer Inc., South Lyon, MI, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Bergeron', 'Affiliation': 'Global Product Development, Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yazdi K', 'Initials': 'YK', 'LastName': 'Pithavala', 'Affiliation': 'Global Product Development, Clinical Pharmacology, Pfizer Oncology, La Jolla, CA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01480-1']
2543,32910434,Maintenance of Response Through up to 4 Years of Continuous Guselkumab Treatment of Psoriasis in the VOYAGE 2 Phase 3 Study.,"BACKGROUND


Guselkumab effectively treats moderate-to-severe psoriasis.
OBJECTIVES


Results of continuous guselkumab treatment through 4 years from VOYAGE 2 are presented.
METHODS


At baseline, 992 patients were randomized to receive guselkumab 100 mg every 8 weeks, placebo, or adalimumab 40 mg every 2 weeks. Placebo-treated patients crossed over to guselkumab at week 16. Weeks 28-76 incorporated randomized withdrawal, and all patients received open-label guselkumab through to week 204. Efficacy was analyzed using pre-specified treatment failure rules (patients were considered nonresponders after discontinuing due to lack of efficacy, worsening of psoriasis, or use of a prohibited treatment). There was no missing data imputation after treatment failure rules. Safety was analyzed through 4 years.
RESULTS


The proportions of guselkumab-treated patients who achieved and maintained designated clinical responses at weeks 100 and 204, respectively, were as follows: at least a 75% improvement in Psoriasis Area and Severity Index from baseline (PASI 75): 94.1% and 92.3%; PASI 90: 79.1% and 79.7%; PASI 100: 48.4% and 51.0%; Investigator's Global Assessment (IGA) score of 0/1: 83.1% and 81.9%; IGA score of 0: 52.7% and 52.7%; Dermatology Life Quality Index score of 0/1: 70.2% and 69.1%; Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0: 35.7% and 39.7%; PSSD sign score of 0: 22.0% and 27.2%; ≥ 5% improvement in Short Form-36 (SF-36) physical component score: 48.8% and 45.0%; ≥ 5% improvement in SF-36 mental component score: 45.1% and 43.2%; Hospital Anxiety and Depression Score (HADS)-anxiety score ≥ 8: 22.9% and 21.7%; and HADS-depression score ≥ 8: 16.6% and 21.0%. Similar findings were reported for the adalimumab → guselkumab group. No new safety signals were identified.
CONCLUSIONS


High efficacy levels were maintained from week 100 through to week 204 with continuous guselkumab treatment, across multiple endpoints, in VOYAGE 2. Guselkumab was well tolerated.
CLINICAL TRIAL REGISTRATION


NCT02207244.",2020,"No new safety signals were identified.
",['992 patients'],"['open-label guselkumab', 'Placebo', 'guselkumab 100\xa0mg every 8\xa0weeks, placebo, or adalimumab']","['Safety', 'Hospital Anxiety and Depression Score', 'Psoriasis Symptoms and Signs Diary (PSSD) symptom score', 'Psoriasis Area and Severity Index', ""Investigator's Global Assessment (IGA) score"", 'Efficacy', 'SF-36 mental component score', 'tolerated', 'Dermatology Life Quality Index score', 'Short Form-36 (SF-36) physical component score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585337', 'cui_str': 'Bimonthly'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}]",992.0,0.113398,"No new safety signals were identified.
","[{'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. kreich@jerucon.com.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Department of Dermatology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""Department of Medicine, The University of Melbourne, St. Vincent's Hospital Melbourne and Probity Medical Research, Skin Health Institute, Carlton, VIC, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Janssen Global Services, LLC, Malvern, PA, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}]",American journal of clinical dermatology,['10.1007/s40257-020-00555-7']
2544,32910450,[Victimization among dual diagnosis patients and effectiveness of the sos training].,"BACKGROUND


Patients with a co-occurring substance use disorder and other mental disorder (dual diagnosis) are at increased risk of victimization: to become victims of for instance physical abuse, sexual abuse, and property crimes.<br/> AIM: To examine the effectiveness of the sos training: a new group-based intervention to improve resilience of dual diagnosis patients and thereby reduce their risk of victimization.<br/> METHOD: A randomized controlled trial was conducted in dual diagnosis patients, with a 14-month follow-up period. Patients were randomized to receive either care as usual (n = 125), or care as usual plus sos training (n =125). The primary outcome measure was defined as treatment response for victimization (yes/no), with 'yes' defined as at least a 50% reduction in the number of past-year victimization incidents at 14-month follow-up compared to baseline.<br/> RESULTS: Significantly more participants in the experimental group achieved positive treatment response for victimization (68%) compared to the control group (54%).<br/> CONCLUSION: Adding sos training to care as usual in dual diagnosis patients is more effective in reducing victimization compared to care as usual alone. The sos training can be implemented in addiction-psychiatry services to prevent future victimization in these patients.",2020,Adding sos training to care as usual in dual diagnosis patients is more effective in reducing victimization compared to care as usual alone.,"['dual diagnosis patients, with a 14-month follow-up period', 'Patients with a co-occurring substance use disorder and other mental disorder (dual diagnosis']","['care as usual (n = 125), or care as usual plus sos training']","[""treatment response for victimization (yes/no), with 'yes' defined as at least a 50% reduction in the number of past-year victimization incidents"", 'positive treatment response for victimization']","[{'cui': 'C0206308', 'cui_str': 'Dual Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4225412', 'cui_str': 'Spondylo-ocular syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",125.0,0.0461378,Adding sos training to care as usual in dual diagnosis patients is more effective in reducing victimization compared to care as usual alone.,"[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'de Waal', 'Affiliation': ''}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Kikkert', 'Affiliation': ''}, {'ForeName': 'J J M', 'Initials': 'JJM', 'LastName': 'Dekker', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Goudriaan', 'Affiliation': ''}]",Tijdschrift voor psychiatrie,[]
2545,32910476,Higher serum PD-L1 level predicts increased overall survival with lapatinib versus trastuzumab in the CCTG MA.31 phase 3 trial.,"BACKGROUND


The purpose of this retrospective biomarker study of the Canadian Cancer Trials Group (CCTG) MA.31 randomized phase 3 trial (lapatinib vs trastuzumab) of HER2-positive metastatic breast cancer (MBC) was to evaluate the prognostic and predictive biomarker utility of pretreatment serum programmed death ligand 1 (PD-L1) levels.
METHODS


CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm). The Ella immunoassay platform (ProteinSimple, San Jose, California) was used to quantitate serum PD-L1 levels. Stepwise forward Cox multivariable analyses were performed for progression-free survival and overall survival (OS).
RESULTS


In the whole trial population, continuous pretreatment serum PD-L1 levels were not associated with OS. However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37). In the whole trial, in a multivariable analysis for OS, serum PD-L1 (median cut point) remained a significant independent covariate (HR, 2.38; P = .001). There was a significant interaction between treatment arm and continuous serum PD-L1 (bootstrap method; P = .0025): at or above 214.2 pg/mL (the 89th percentile), serum PD-L1 was associated with significantly shorter OS with trastuzumab treatment versus lapatinib treatment.
CONCLUSIONS


In the CCTG MA.31 trial, serum PD-L1 was a significant predictive factor: a higher pretreatment serum PD-L1 level was associated with shorter OS with trastuzumab treatment but with longer OS with lapatinib treatment. Immune evasion may decrease the effectiveness of trastuzumab therapy. Further evaluation of elevated serum PD-L1 in advanced breast cancer is warranted to identify patients with HER2-positive MBC who may benefit from novel immune-targeted therapies in addition to trastuzumab.",2020,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","['CCTG MA.31 accrued 652 HER2-positive patients; 387 had serum available (185 in the trastuzumab arm and 202 in the lapatinib arm', 'HER2-positive metastatic breast cancer (MBC', 'patients with HER2-positive MBC']","['lapatinib versus trastuzumab', 'lapatinib vs trastuzumab']","['serum PD-L1', 'progression-free survival and overall survival (OS', 'serum PD-L1 levels', 'serum PD-L1 level', 'overall survival']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C4721209', 'cui_str': 'Metastatic human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",652.0,0.0795987,"However, within the trastuzumab arm, a higher continuous pretreatment serum PD-L1 level was significant for shorter OS (hazard ratio [HR], 3.85; P = .04), but within the lapatinib arm, pretreatment serum PD-L1 was not associated with OS (P = .37).","[{'ForeName': 'Prashanth', 'Initials': 'P', 'LastName': 'Moku', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Shepherd', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Suhail M', 'Initials': 'SM', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Leitzel', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Wendy R', 'Initials': 'WR', 'LastName': 'Parulekar', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Virk', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Nomikos', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Aparicio', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Drabick', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Cream', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'E Scott', 'Initials': 'ES', 'LastName': 'Halstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Umstead', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Mckeone', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Hyma', 'Initials': 'H', 'LastName': 'Polimera', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Maddukuri', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Aamnah', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Vinod', 'Initials': 'V', 'LastName': 'Nagabhairu', 'Affiliation': 'Pinnacle Health, Harrisburg, Pennsylvania.'}, {'ForeName': 'Joyson', 'Initials': 'J', 'LastName': 'Poulose', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pancholy', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'ProteinSimple, San Jose, California.'}, {'ForeName': 'Bingshu E', 'Initials': 'BE', 'LastName': 'Chen', 'Affiliation': ""Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Lipton', 'Affiliation': 'Penn State Hershey Medical Center, Hershey, Pennsylvania.'}]",Cancer,['10.1002/cncr.33149']
2546,32910478,Results of an early safety analysis of a study of the combination of pembrolizumab and pelvic chemoradiation in locally advanced cervical cancer.,"BACKGROUND


Immune checkpoint inhibitors are being considered for locally advanced cervical cancer (LACC) together with standard-of-care pelvic chemoradiation (CRT). However, the safety of the combination and its optimal schedule are unknown. Defining the safety of the combination is a primary objective of a study examining concurrent and sequential schedules. This article presents a safety analysis that was fully accrued and met reporting requirements.
METHODS


Pembrolizumab was given after CRT (arm 1) or during CRT (arm 2) according to a randomized phase 2 design. Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system) were randomized 1:1 to the treatment regimens. The CRT was identical in the 2 arms. Pembrolizumab was administered every 3 weeks for 3 doses; no maintenance was allowed. All patients receiving any treatment were evaluated for safety. Safety assessments included the incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT) through 30 days after the last pembrolizumab infusion.
RESULTS


As of August 2019, 52 of the 88 planned patients had completed treatment and were evaluable for toxicity. Treatment-related grade 2 or higher toxicity was experienced by 88%; 11 had at least 1 grade 4 AE, and another 23 had at least 1 grade 3 AE. Grade 1 or higher diarrhea was reported in 34 patients (65%; 50% of these were grade 1), and there was no difference between arms (63% in arm 1 vs 68% in arm 2). Two patients experienced 3 DLTs. Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
CONCLUSIONS


Preliminary results support the safety and feasibility of adding pembrolizumab to pelvic CRT concurrently or sequentially.
LAY SUMMARY


Pembrolizumab is a humanized antibody against programmed cell death protein 1 that is used in cancer immunotherapy. Preliminary data suggest that pembrolizumab can be safely combined with chemotherapy and pelvic radiation in the treatment of locally advanced cervical cancer. Future studies of the addition of immunotherapy to traditional chemoradiation are planned to determine the best way to deliver the treatment and whether any improvement is seen with the addition of immunotherapy to traditional therapy.",2020,"Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
","['locally advanced cervical cancer', 'Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system']","['pembrolizumab and pelvic chemoradiation', 'pembrolizumab', 'cisplatin', 'chemotherapy and pelvic radiation', 'Pembrolizumab']","['Grade 1 or higher diarrhea', 'toxicity', 'incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456597', 'cui_str': 'Stage 1B'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",,0.105333,"Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab.
","[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Scalici', 'Affiliation': 'Mitchell Cancer Institute, USA Health, Mobile, Alabama.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Temkin', 'Affiliation': 'Anne Arundel Medical Center, Annapolis, Maryland.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Schwarz', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine, Saint Louis, Missouri.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Crane', 'Affiliation': 'Division of Gynecologic Oncology, Levine Cancer Institute, Charlotte, North Carolina.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Moxley', 'Affiliation': 'Stephenson Cancer Center, University of Oklahoma Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Inova Schar Cancer Institute, Fairfax, Virginia.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Wethington', 'Affiliation': 'Division of Gynecologic Oncology, Department of Gynecology and Obstetrics, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Gina R', 'Initials': 'GR', 'LastName': 'Petroni', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Nikole E', 'Initials': 'NE', 'LastName': 'Varhegyi', 'Affiliation': 'Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Sheena H', 'Initials': 'SH', 'LastName': 'Clift', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Timothy N J', 'Initials': 'TNJ', 'LastName': 'Bullock', 'Affiliation': 'Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia.'}, {'ForeName': 'Timothy N', 'Initials': 'TN', 'LastName': 'Showalter', 'Affiliation': 'Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia.'}]",Cancer,['10.1002/cncr.33136']
2547,32913843,"Effect of a 12-week training program on the anthropometric and physiological profiles of some participants registered in a fitness center in Douala, Cameroon.","Fitness centers are remarkably abundant in Cameroon. The aim of this work was to assess the effects of a 12-week training program on the anthropometric and physiological profiles of some participants in a fitness center. A total of 86 participants (40 from the experimental group and 46 from the control group) with age ranging from 17 to 53 years were subjected to pre- and posttraining assessments of, anthropometric parameters, physiological parameters, and performance. Anthropometric parameters (weight, height, body mass index [BMI], waist circumference [WC]) and blood pressure (diastolic blood pressure, systolic blood pressure [SBP]) were measured according to standard protocols. Heart rate was recorded using a heart rate monitor. Cardiorespiratory fitness (maximal oxygen uptake or VO 2peak ) was estimated by the 20-multistage shuttle run test. All the data was collected twice within 12 weeks. Weight, BMI, and WC did not show any significant variation ( P >0.05) after a 12-week training program. VO 2peak  increase was insignificant ( P >0.05) higher in men (7.5%,  P =0.06), compared to women (5.4%,  P =0.4). We noticed a significant reduction ( P =0.002) in the SBP of men. Significant increase of HR max was found in women. There was an improvement of 13.7% in the VO 2peak  of the participants who did not consume alcohol. These results demonstrate the slight benefits of a 12-week training program on health. The weight characteristics of the participants and lifestyle may play an important role in these interactions.",2020,"VO 2peak  increase was insignificant ( P >0.05) higher in men (7.5%,  P =0.06), compared to women (5.4%,  P =0.4).","['participants registered in a fitness center in Douala, Cameroon', 'some participants in a fitness center', '86 participants (40 from the experimental group and 46 from the control group) with age ranging from 17 to 53 years']",['training program'],"['Anthropometric parameters (weight, height, body mass index [BMI], waist circumference [WC]) and blood pressure (diastolic blood pressure, systolic blood pressure [SBP', 'Heart rate', 'HR max', 'Weight, BMI, and WC', 'Cardiorespiratory fitness (maximal oxygen uptake or VO 2peak ']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C0574438', 'cui_str': 'Duala language'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",86.0,0.0139777,"VO 2peak  increase was insignificant ( P >0.05) higher in men (7.5%,  P =0.06), compared to women (5.4%,  P =0.4).","[{'ForeName': 'Peguy Brice Assomo', 'Initials': 'PBA', 'LastName': 'Ndemba', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Clarisse Noël Ayina', 'Initials': 'CNA', 'LastName': 'Ayina', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Wiliam Richard', 'Initials': 'WR', 'LastName': 'Guessogo', 'Affiliation': 'National Institute of Youth and Sports of Yaounde, Yaounde, Cameroon.'}, {'ForeName': 'Jerson Mekoulou', 'Initials': 'JM', 'LastName': 'Ndongo', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Rita Ornella Ghontchouang', 'Initials': 'ROG', 'LastName': 'Kamnang', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Claude Elysée Bika', 'Initials': 'CEB', 'LastName': 'Lele', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Samuel Honoré', 'Initials': 'SH', 'LastName': 'Mandengue', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}, {'ForeName': 'Laurent Serge', 'Initials': 'LS', 'LastName': 'Etoundi-Ngoa', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon.'}, {'ForeName': 'Abdou', 'Initials': 'A', 'LastName': 'Temfemo', 'Affiliation': 'Exercise and Sport Physiology Unit, Faculty of Sciences, University of Douala, Douala, Cameroon.'}]",Journal of exercise rehabilitation,['10.12965/jer.2040340.170']
2548,32913993,Exploratory Analysis of Single-Gene Predictive Biomarkers in HERA DASL Cohort Reveals That C8A mRNA Expression Is Prognostic of Outcome and Predictive of Benefit of Trastuzumab.,"Purpose


The Herceptin Adjuvant study is an international multicenter randomized trial that compared 1 or 2 years of trastuzumab given every 3 weeks with observation in women with human epidermal growth factor 2-positive (HER2+) breast cancer after chemotherapy. Identification of biomarkers predictive of a benefit from trastuzumab will minimize overtreatment and lower health care costs.
Methods


To identify possible single-gene biomarkers, an exploratory analysis of 3,669 gene probes not expected to be expressed in normal breast tissue was conducted. Disease-free survival (DFS) was used as the end point in a Cox regression model, with the interaction term between C8A mRNA and treatment as a categorical variable split on the cohort mean.
Results


A significant interaction between C8A mRNA and treatment was detected ( P  < .001), indicating a predictive response to trastuzumab treatment. For the C8A-low subgroup (mRNA expression lower than the cohort mean), no significant treatment benefit was observed ( P  = .73). In the C8A-high subgroup, patients receiving trastuzumab experienced a lower hazard of a DFS event by approximately 75% compared with those in the observation arm (hazard ratio [HR], 0.25;  P  < .001). A significant prognostic effect of C8A mRNA also was seen ( P  < .001) in the observation arm, where the C8A-high group hazard of a DFS event was three times the respective hazard of the C8A-low group (HR, 3.27;  P  < .001). C8A mRNA is highly prognostic in the Hungarian Academy of Science HER2+ gastric cancer cohort (HR, 1.72;  P  < .001).
Conclusion


C8A as a single-gene biomarker prognostic of DFS and predictive of a benefit from trastuzumab has the potential to improve the standard of care in HER2+ breast cancer if validated by additional studies. Understanding the advantage of overexpression of C8A related to the innate immune response can give insight into the mechanisms that drive cancer.",2018,"A significant prognostic effect of C8A mRNA also was seen ( P  < .001) in the observation arm, where the C8A-high group hazard of a DFS event was three times the respective hazard of the C8A-low group (HR, 3.27;  P  < .001).",['women with human epidermal growth factor 2-positive (HER2+) breast cancer after chemotherapy'],"['trastuzumab', 'C8A mRNA']","['DFS event', 'Disease-free survival (DFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1509244', 'cui_str': 'human epidermal growth factor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0398766,"A significant prognostic effect of C8A mRNA also was seen ( P  < .001) in the observation arm, where the C8A-high group hazard of a DFS event was three times the respective hazard of the C8A-low group (HR, 3.27;  P  < .001).","[{'ForeName': 'Scooter', 'Initials': 'S', 'LastName': 'Willis', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Varvara', 'Initials': 'V', 'LastName': 'Polydoropoulou', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Yuliang', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Zoi', 'Initials': 'Z', 'LastName': 'Tsourti', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Karlis', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Long', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Xiaoqian', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Theel', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Győrffy', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abramovitz', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Dafni', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leyland-Jones', 'Affiliation': ', , , , , , , , and , Avera Cancer Institute, Sioux Falls, SD; , , , and , Frontier Science Foundation-Hellas; , University of Athens, Athens, Greece; , Scripps Florida, Jupiter, FL; , MTA-TTK Lendület Cancer Biomarker Research Group, Budapest, Hungary; and , Royal Marsden Hospital, London, United Kingdom.'}]",JCO precision oncology,['10.1200/PO.18.00016']
2549,32914010,Genomic Instability and  TP53  Genomic Alterations Associate With Poor Antiproliferative Response and Intrinsic Resistance to Aromatase Inhibitor Treatment.,"PURPOSE


Although aromatase inhibitor (AI) treatment is effective in estrogen receptor-positive postmenopausal breast cancer, resistance is common and incompletely explained. Genomic instability, as measured by somatic copy number alterations (SCNAs), is important in breast cancer development and prognosis. SCNAs to specific genes may drive intrinsic resistance, or high genomic instability may drive tumor heterogeneity, which allows differential response across tumors and surviving cells to evolve resistance to treatment rapidly. We therefore evaluated the relationship between SCNAs and intrinsic resistance to treatment as measured by a poor antiproliferative response.
PATIENTS AND METHODS


SCNAs were determined by single nucleotide polymorphism array in baseline and surgery core-cuts from 73 postmenopausal patients randomly assigned to receive 2 weeks of preoperative AI or no AI in the Perioperative Endocrine Therapy-Individualizing Care (POETIC) trial. Fifty-six samples from the AI group included 28 poor responders (PrRs, less than 60% reduction in protein encoded by the  MKI67  gene [Ki-67]) and 28 good responders (GdRs, greater than 75% reduction in Ki-67). Exome sequencing was available for 72 pairs of samples.
RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048). The SCNA with the largest difference between GdRs and PrRs was loss of heterozygosity observed at 17p (false discovery rate, 0.08), which includes  TP53.  Nine of 28 PrRs had loss of wild-type  TP53  as a result of mutations and loss of heterozygosity compared with three of 28 GdRs. In PrRs, somatic alterations of  TP53  were associated with higher genomic instability, higher baseline Ki-67, and greater resistance to AI treatment compared with wild-type  TP53 .
CONCLUSION


We observed that primary tumors with high genomic instability have an intrinsic resistance to AI treatment and do not require additional evolution to develop resistance to estrogen deprivation therapy.",2019,"RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048).",['SCNAs were determined by single nucleotide polymorphism array in baseline and surgery core-cuts from 73 postmenopausal patients'],"['preoperative AI or no AI in the Perioperative Endocrine Therapy-Individualizing Care', 'aromatase inhibitor (AI) treatment']","['Ki-67 expression', 'heterozygosity']","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}]",73.0,0.0322576,"RESULTS


Genomic instability correlated with Ki-67 expression at both baseline ( P  < .001) and surgery ( P  < .001) and was higher in PrRs ( P  = .048).","[{'ForeName': 'Eugene F', 'Initials': 'EF', 'LastName': 'Schuster', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Gellert', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Corrinne V', 'Initials': 'CV', 'LastName': 'Segal', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'López-Knowles', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Buus', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Maggie Chon U', 'Initials': 'MCU', 'LastName': 'Cheang', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morden', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCO precision oncology,['10.1200/PO.18.00286']
2550,32914038,Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A Bayesian Adaptive Platform Trial to Develop Precision Medicines for Patients With Glioblastoma.,"PURPOSE


Adequately prioritizing the numerous therapies and biomarkers available in late-stage testing for patients with glioblastoma (GBM) requires an efficient clinical testing platform. We developed and implemented INSIGhT (Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM.
METHODS


INSIGhT compares experimental arms with a common control of standard concurrent temozolomide and radiation therapy followed by adjuvant temozolomide. The primary end point is overall survival. Patients with newly diagnosed unmethylated GBM who are  IDH  R132H mutation negative and with genomic data available for biomarker grouping are eligible. At the initiation of INSIGhT, three experimental arms (neratinib, abemaciclib, and CC-115), each with a proposed genomic biomarker, are tested simultaneously. Initial randomization is equal across arms. As the trial progresses, randomization probabilities adapt on the basis of accumulating results using Bayesian estimation of the biomarker-specific probability of treatment impact on progression-free survival. Treatment arms may drop because of low probability of treatment impact on overall survival, and new arms may be added. Detailed information on the statistical model and randomization algorithm is provided to stimulate discussion on trial design choices more generally and provide an example for other investigators developing APTs.
CONCLUSION


INSIGhT (NCT02977780) is an ongoing novel biomarker-based, Bayesian APT for patients with newly diagnosed unmethylated GBM. Our goal is to dramatically shorten trial execution timelines while increasing scientific power of results and biomarker discovery using adaptive randomization. We anticipate that trial execution efficiency will also be improved by using the APT format, which allows for the collaborative addition of new experimental arms while retaining the overall trial structure.",2019,"(Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM.
","['patients with glioblastoma (GBM', 'patients with newly diagnosed unmethylated GBM', 'Patients with newly diagnosed unmethylated GBM who are  IDH  R132H mutation negative and with genomic data available for biomarker grouping are eligible', 'Patients With Glioblastoma']","['INSIGhT', 'standard concurrent temozolomide and radiation therapy followed by adjuvant temozolomide', 'Innovative Glioblastoma Therapy (INSIGhT']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.147939,"(Individualized Screening Trial of Innovative Glioblastoma Therapy) as a novel adaptive platform trial (APT) to develop precision medicine approaches in GBM.
","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Alexander', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gaffey', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Arrillaga-Romany', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Eudocia Q', 'Initials': 'EQ', 'LastName': 'Lee', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Mikael L', 'Initials': 'ML', 'LastName': 'Rinne', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Manmeet S', 'Initials': 'MS', 'LastName': 'Ahluwalia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Fell', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Evanthia', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'de Groot', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Drappatz', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Lassman', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Meredith', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'L Burt', 'Initials': 'LB', 'LastName': 'Nabors', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Santagata', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schiff', 'Affiliation': 'University of Virginia Health System, Charlottesville, VA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Welch', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Ligon', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Patrick Y', 'Initials': 'PY', 'LastName': 'Wen', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",JCO precision oncology,['10.1200/PO.18.00071']
2551,32914161,"Analgesic Effect of Intrathecal Fentanyl vs Dexmedetomidine as Adjuvants to Bupivacaine Following Abdominal Surgery for Cancer in Children, a Randomized Trial.","BACKGROUND


Intrathecal fentanyl in spinal anesthesia improves intra- and postoperative analgesia. Dexmedetomidine is a fascinating adjuvant with regards to neuraxial anesthesia in children experiencing surgery for abdominal malignancy.
PATIENTS AND METHODS


After endorsement by the institutional reviewing board (IRB) and guardians' written informed consent, this research was carried out on 60 pediatric malignancy patients scheduled for major abdominal surgery. Children were randomly distributed into three groups (20 patients each): Group C: given 2 mL of bupivacaine 0.5% (0.4 mg/kg) intrathecally, injected gradually over 20 seconds. Group F: the same as group C, plus fentanyl 0.2 μg/kg. Group D: the same as group C, plus dexmedetomidine 0.2 μg/kg. Pain at zero, two, four, six, 12, 18, and 24 hours postoperatively was evaluated by Face, Legs, Activity, Crying, and Consolability (FLACC) score. First analgesic request and postoperative unfavorable effects were recorded for 24 hours postoperatively.
RESULTS


A significant decrease was recognized in the mean FLACC score in groups D and F at six, eight, and 12 hours postoperatively, in contrast to group C (P ≤ 0.05). First analgesic request was significantly prolonged in group D (7.67 ± 0.57 hours), in contrast to groups F and C (5.40 ± 1.09 hours and 4.23 ± 3.27 hours, respectively, P < 0.04). Paracetamol utilization was significantly decreased in group D (316.67 ± 28.86 mg), in contrast to group C (391.00 ± 52.00 mg, P < 0.03), without a significant difference between group F (354.44 ± 46.67 mg) and groups D and C (P > 0.05).
CONCLUSIONS


Adding dexmedetomidine and fentanyl to intrathecal bupivacaine improved postoperative analgesia following abdominal surgery for cancer in children, with better overall analgesia of dexmedetomidine compared with fentanyl.",2020,"A significant decrease was recognized in the mean FLACC score in groups D and F at six, eight, and 12 hours postoperatively, in contrast to group C (P ≤ 0.05).","['60 pediatric malignancy patients scheduled for major abdominal surgery', 'children experiencing surgery for abdominal malignancy', 'abdominal surgery for cancer in children', 'Abdominal Surgery for Cancer in Children']","['bupivacaine', 'Bupivacaine', 'fentanyl', 'Intrathecal Fentanyl vs Dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine']","['First analgesic request', 'postoperative analgesia', 'mean FLACC score', 'Face, Legs, Activity, Crying, and Consolability (FLACC) score', 'Paracetamol utilization', 'intra- and postoperative analgesia', 'Pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0381543,"A significant decrease was recognized in the mean FLACC score in groups D and F at six, eight, and 12 hours postoperatively, in contrast to group C (P ≤ 0.05).","[{'ForeName': 'Khaled Mohamed', 'Initials': 'KM', 'LastName': 'Fares', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Sahar Abdel-Baky', 'Initials': 'SA', 'LastName': 'Mohamed', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmad Mohammad', 'Initials': 'AM', 'LastName': 'Abd El-Rahman', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Rania Mohammed', 'Initials': 'RM', 'LastName': 'AbdeLemam', 'Affiliation': 'Anesthesia, Intensive Care and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Amira Mahmoud Mohamed', 'Initials': 'AMM', 'LastName': 'Osman', 'Affiliation': 'Pediatric Oncology, South Egypt Cancer Institute, Assiut University, Assiut, Egypt.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa259']
2552,32914169,Brief collaborative care intervention to reduce perceived unmet needs in highly distressed breast cancer patients: randomized controlled trial.,"OBJECTIVES


Our newly developed brief collaborative care intervention program has been suggested to be effective in reducing breast cancer patients' unmet needs and psychological distress; however, there has been no controlled trial to investigate its effectiveness. The purpose of this study was to examine the effectiveness of the program in relation to patients' perceived needs and other relevant outcomes for patients including quality of life, psychological distress and fear of recurrence (Clinical trial register; UMIN-CTR, Clinical registration number; R5172).
METHODS


Fifty-nine highly distressed breast cancer patients receiving adjuvant chemotherapy and/or hormonal therapy were randomly assigned either to a treatment as usual group or to a collaborative care intervention, consisting of four sessions that mainly included assessment of the patients' perceived needs, learning skills of problem-solving treatment for coping with unmet needs and psycho-education provided by trained nurses supervised by a psycho-oncologist.
RESULTS


Although >80% of the eligible patients agreed to participate, and >90% of participants completed the intervention, there were no significant differences with regard to patients' needs, quality of life, psychological distress and fear of recurrence, both at 1 and 3 months after intervention.
CONCLUSION


Newly developed brief collaborative care intervention program was found to be feasible and acceptable. The trial, however, failed to show the effectiveness of the program on patients' relevant subjective outcomes. Further intervention program having both brevity and sufficient intensity should be developed in future studies.",2020,"The trial, however, failed to show the effectiveness of the program on patients' relevant subjective outcomes.","['highly distressed breast cancer patients', 'Fifty-nine highly distressed breast cancer patients receiving adjuvant chemotherapy and/or hormonal therapy']","[""collaborative care intervention, consisting of four sessions that mainly included assessment of the patients' perceived needs, learning skills of problem-solving treatment for coping with unmet needs and psycho-education provided by trained nurses supervised by a psycho-oncologist"", 'Brief collaborative care intervention']","['quality of life, psychological distress and fear of recurrence']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",59.0,0.11753,"The trial, however, failed to show the effectiveness of the program on patients' relevant subjective outcomes.","[{'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Momino', 'Affiliation': 'Department of Nursing Administration and Management, Nagoya City University Graduate School of Nursing, Nagoya, Japan.'}, {'ForeName': 'Fujika', 'Initials': 'F', 'LastName': 'Katsuki', 'Affiliation': 'Department of Psychiatric and Mental Health Nursing, Nagoya City University School of Nursing, Nagoya, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast Surgery, Division of Surgery, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sugiura', 'Affiliation': 'Department of Breast and Endocrine Surgery, Nagoya City West Medical Center, Nagoya, Japan.'}, {'ForeName': 'Nobuyasu', 'Initials': 'N', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kariya Toyota General Hospital, Kariya, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Wanifuchi-Endo', 'Affiliation': 'Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa166']
2553,32914237,R0 resection following chemo (radio)therapy improves survival of primary inoperable pancreatic cancer patients. Interim results of the German randomized CONKO-007± trial.,"PURPOSE


Chemotherapy with or without radiotherapy is the standard in patients with initially nonmetastatic unresectable pancreatic cancer. Additional surgery is in discussion. The CONKO-007 multicenter randomized trial examines the value of radiotherapy. Our interim analysis showed a significant effect of surgery, which may be relevant to clinical practice.
METHODS


One hundred eighty patients received induction chemotherapy (gemcitabine or FOLFIRINOX). Patients without tumor progression were randomized to either chemotherapy alone or to concurrent chemoradiotherapy. At the end of therapy, a panel of five independent pancreatic surgeons judged the resectability of the tumor.
RESULTS


Following induction chemotherapy, 126/180 patients (70.0%) were randomized to further treatment. Following study treatment, 36/126 patients (28.5%) underwent surgery; (R0: 25/126 [19.8%]; R1/R2/Rx [n = 11/126; 6.1%]). Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003). In the 25 patients with R0 resected tumors before treatment, only 6/113 (5.3%) of the recommendations of the panel surgeons recommended R0 resectability, compared with 17/48 (35.4%) after treatment (p < 0.001).
CONCLUSION


Tumor resectability of pancreatic cancer staged as unresectable at primary diagnosis should be reassessed after neoadjuvant treatment. The patient should undergo surgery if a resectability is reached, as this significantly improves their prognosis.",2020,"Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003).","['primary inoperable pancreatic cancer patients', '36/126 patients (28.5%) underwent surgery', '126/180 patients (70.0', 'patients with initially nonmetastatic unresectable pancreatic cancer', 'One hundred eighty patients received', 'Patients without tumor progression']","['chemotherapy alone or to concurrent chemoradiotherapy', 'induction chemotherapy (gemcitabine or FOLFIRINOX', 'Chemotherapy with or without radiotherapy', 'R0 resection following chemo (radio)therapy', 'radiotherapy']","['R0 resectability', 'Disease-free survival (DFS) and overall survival (OS']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0854776', 'cui_str': 'Pancreatic carcinoma non-resectable'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4742253', 'cui_str': 'folfirinox'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",180.0,0.0915041,"Disease-free survival (DFS) and overall survival (OS) were significantly better for patients with R0 resected tumors (median DFS and OS: 16.6 months and 26.5 months, respectively) than for nonoperated patients (median DFS and OS: 11.9 months and 16.5 months, respectively; p = 0.003).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. rainer.fietkau@uk-erlangen.de.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'U A', 'Initials': 'UA', 'LastName': 'Wittel', 'Affiliation': 'Department for General- and Visceral Surgery, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Croner', 'Affiliation': 'Department of Surgery, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jacobasch', 'Affiliation': 'Private practice, Hematology/Oncology, Dresden, Germany.'}, {'ForeName': 'U P', 'Initials': 'UP', 'LastName': 'Neumann', 'Affiliation': 'Department of Surgery, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Reinacher-Schick', 'Affiliation': 'Department for Hematology, Oncology and Palliative Care, St Josef-Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Imhoff', 'Affiliation': 'Department of Radiation Oncology, Universitätsklinikum Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boeck', 'Affiliation': 'Department of Medical Oncology and Comprehensive Cancer Centre, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Keilholz', 'Affiliation': 'Department of Radiotherapy, Clinical Center Bayreuth, Bayreuth, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oettle', 'Affiliation': 'Outpatient Department Hematology/Oncology, Friedrichshafen, Germany.'}, {'ForeName': 'W M', 'Initials': 'WM', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Golcher', 'Affiliation': 'Department of Surgery, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'W O', 'Initials': 'WO', 'LastName': 'Bechstein', 'Affiliation': 'Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Uhl', 'Affiliation': 'Department of Surgery, St. Josef Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pirkl', 'Affiliation': 'Medical Centre for Information and Communication Technology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Adler', 'Affiliation': 'Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nürnberg, Waldstraße\xa06, 91054, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Semrau', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rutzner', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, Medical Center, Georg-August-University Göttingen, Göttingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lubgan', 'Affiliation': 'Department of Radiation Oncology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01680-2']
2554,32914563,Comparison of the phaco chop and drill-and-crack techniques for phacoemulsification of hard cataracts: A fellow eye study.,"PURPOSE


To quantify the intraoperative parameters and postoperative outcomes after using the phaco chop technique in one eye and drill-and-crack technique in the other eye in patients with bilateral dense brunescent cataract.
METHODS


The Lens Opacities Classification System III grading system was used to select 132 eyes of 66 patients with bilateral nuclear opalescence (NO) grade NO4 or grade NO5. One eye in each patient with bilateral dense brunescent cataract was subjected to phacoemulsification using the phaco chop technique, while the other eye was subjected to phacoemulsification with the drill-and-crack technique for nucleus disassembly. The intraoperative parameters were quantified. Surgical outcome was assessed preoperatively and 1 day, 4 weeks and 12 weeks postoperatively, and the outcomes of the two techniques were compared.
RESULTS


There was no significant difference between the techniques in operative parameters [cumulative dissipated energy (p = 0.74), surgical time (p = 0.68) or surgical difficulty during nucleus disassembly (p = 0.80)]. There was no significant difference in the postoperative change in central corneal thickness between the techniques at day 1, 4 weeks and 12 weeks or in corneal endothelial cell density loss at 4 and 12 weeks (p > 0.05). There was no significant difference between the techniques in the mean corrected distance visual acuity (logarithm of the minimum angle resolution) at 4 weeks postoperatively (p = 0.25).
CONCLUSION


The phaco chop and drill-and-crack techniques are equally effective for disassembly of hard NO4 and NO5 cataracts.",2020,"There was no significant difference between the techniques in the mean corrected distance visual acuity (logarithm of the minimum angle resolution) at 4 weeks postoperatively (p = 0.25).
","['patients with bilateral dense brunescent cataract', 'phacoemulsification of hard cataracts', '132 eyes of 66 patients with bilateral nuclear opalescence (NO) grade NO4 or grade NO5']","['phacoemulsification using the phaco chop technique, while the other eye was subjected to phacoemulsification with the drill-and-crack technique for nucleus disassembly', 'phaco chop and drill-and-crack techniques']","['corneal endothelial cell density loss', 'surgical time', 'postoperative change in central corneal thickness', 'operative parameters [cumulative dissipated energy', 'mean corrected distance visual acuity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0271167', 'cui_str': 'Cataracta brunescens'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}]",66.0,0.0539541,"There was no significant difference between the techniques in the mean corrected distance visual acuity (logarithm of the minimum angle resolution) at 4 weeks postoperatively (p = 0.25).
","[{'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Abdelmotaal', 'Affiliation': 'Department of Ophthalmology, Faculty of medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdel-Radi', 'Affiliation': 'Department of Ophthalmology, Faculty of medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mahmoud F', 'Initials': 'MF', 'LastName': 'Rateb', 'Affiliation': 'Department of Ophthalmology, Faculty of medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Zeiad H', 'Initials': 'ZH', 'LastName': 'Eldaly', 'Affiliation': 'Department of Ophthalmology, Faculty of medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Abdelazeem', 'Affiliation': 'Department of Ophthalmology, Faculty of medicine, Assiut University, Assiut, Egypt.'}]",Acta ophthalmologica,['10.1111/aos.14582']
2555,32914569,"Adiposity and cardiovascular outcomes in three-year-old children of participants in UPBEAT, an RCT of a complex intervention in pregnant women with obesity.","BACKGROUND


Maternal obesity is associated with offspring cardiometabolic risk. UPBEAT was a randomised controlled trial of an antenatal diet and physical activity intervention in 1555 women with obesity. The intervention was associated with lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity at six months.
OBJECTIVE


We have investigated whether the UPBEAT intervention influenced childhood cardiometabolic outcomes or was associated with sustained improvements in maternal lifestyle 3-years after delivery.
METHODS


In UPBEAT mother-child dyads at the 3-year follow-up, we assessed childhood blood pressure, resting pulse rate, and adiposity (body mass index, skinfold thicknesses, body fat, waist and arm circumferences) and maternal diet, physical activity, and anthropometry.
RESULTS


514 three-year-old children attended the appointment (49% intervention, 51% standard care). There was no difference in the main outcome of interest, subscapular skinfold thickness, between the trial arms (-0.30 mm, 95% confidence interval: -0.92, 0.31). However, the intervention was associated with a lower resting pulse rate (-5 bpm [-8.41, -1.07]). There was also a non-significant lower odds of overweight/obesity (OR 0.73; 0.50, 1.08). Maternal dietary improvements observed in the UPBEAT trial, including glycaemic load and saturated fat were maintained 3-years postpartum.
CONCLUSION


This study has demonstrated that an antenatal dietary and physical activity intervention in women with obesity is associated with lower offspring pulse rate and sustained improvement in maternal diet. Whilst larger than previous cohorts, there remains potential for bias from attrition and these findings require validation in future cohorts.",2020,"The intervention was associated with lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity at six months.
","['three-year-old children of participants in', 'women with obesity', 'pregnant women with obesity', '514 three-year-old children attended the appointment (49% intervention, 51% standard care', '1555 women with obesity']","['UPBEAT intervention', 'antenatal dietary and physical activity intervention', 'antenatal diet and physical activity intervention', 'UPBEAT']","['glycaemic load and saturated fat', 'childhood blood pressure, resting pulse rate, and adiposity (body mass index, skinfold thicknesses, body fat, waist and arm circumferences) and maternal diet, physical activity, and anthropometry', 'overweight/obesity', 'lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity', 'childhood cardiometabolic outcomes', 'Adiposity and cardiovascular outcomes', 'interest, subscapular skinfold thickness', 'resting pulse rate']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",1555.0,0.0905984,"The intervention was associated with lower gestational weight gain, healthier diet and metabolic profile in pregnancy, and reduced infant adiposity at six months.
","[{'ForeName': 'Kathryn V', 'Initials': 'KV', 'LastName': 'Dalrymple', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Florence A S', 'Initials': 'FAS', 'LastName': 'Tydeman', 'Affiliation': 'Department of Mathematics and Statistics, Faculty of Science, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Taylor', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Flynn', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Majella', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': ""Department of Nutritional Sciences, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Briley', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paramala', 'Initials': 'P', 'LastName': 'Santosh', 'Affiliation': ""Department of Child and Adolescent Psychiatry, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hayes', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Robson', 'Affiliation': 'Institute of Cellular Medicine, Uterine Cell Signalling Group, The Medical School, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Nelson', 'Affiliation': 'School of Medicine, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, British Heart Foundation, Glasgow, Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Whitworth', 'Affiliation': ""Maternity Services, Central Manchester University Hospitals NHS Foundation Trust, St Mary's Hospital, Manchester, UK.""}, {'ForeName': 'Harriet L', 'Initials': 'HL', 'LastName': 'Mills', 'Affiliation': 'MRC Integrative Epidemiology Unit at the University of Bristol, Oakfield House, Bristol, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Singh', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed CStat', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'White', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Lawlor', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, Bristol, UK.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Godfrey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit and NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Lucilla', 'Initials': 'L', 'LastName': 'Poston', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric obesity,['10.1111/ijpo.12725']
2556,32914581,"Achieving clinically meaningful quality of life benefits in nocturia takes time: Results from a long-term, multicenter phase 3 study of desmopressin in Japanese patients.","OBJECTIVES


To investigate the long-term efficacy, quality of life (QoL), and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese patients with nocturia.
METHODS


A long-term, multicenter phase 3 study was conducted that enrolled Japanese male and female patients with nocturia (NCT03051009). Male patients received desmopressin 25- or 50-μg ODTs, and female patients received desmopressin 25-μg ODTs for up to 1 year. The primary endpoint was safety. Secondary endpoints included change from baseline in number of nocturnal voids, time to first awakening to void, and QoL assessments (nocturia-specific zQoL [N-QoL], Insomnia Severity Index [ISI], and Hsu bother score).
RESULTS


Overall, 503 patients were enrolled. Reductions from baseline in mean number of nocturnal voids were observed in all treatment groups from week 1 (-0.62 to -1.00), with improvements continuing through week 52 (-1.39 to -1.71). Changes from baseline above or approximating a clinically meaningful improvement were seen by week 52 in the disease-specific N-QoL total score (improved by 11.5-22.6), ISI (improved by -3.9 to -7.1), and Hsu bother scores (improved by -1.5 to -2.0). Adverse events (AEs) were reported in 54.9% of desmopressin-treated patients. Most AEs were mild or moderate in severity.
CONCLUSIONS


Desmopressin ODTs (25 and 50 μg) demonstrated long-term efficacy, improved QoL, and were well tolerated in Japanese male and female patients with nocturia treated for up to 1 year. Clinically meaningful improvements in patients' QoL, assessed by N-QoL, sleep quality, and bother, occur later than objective symptom improvements, such as voids.",2020,"Changes from baseline above or approximating a clinically meaningful improvement were seen by week 52 in the disease-specific N-QoL total score (improved by 11.5-22.6), ISI (improved by -3.9 to -7.1), and Hsu bother scores (improved by -1.5 to -2.0).","['Male patients received', 'Japanese male and female patients with nocturia treated for up to 1\u2009year', 'Japanese patients with nocturia', '503 patients were enrolled', 'enrolled Japanese male and female patients with nocturia (NCT03051009', 'Japanese patients']","['desmopressin', 'Desmopressin ODTs', 'desmopressin 25-μg ODTs', 'desmopressin orally disintegrating tablets (ODTs']","['N-QoL, sleep quality, and bother, occur later than objective symptom improvements, such as voids', 'mean number of nocturnal voids', 'Hsu bother scores', 'disease-specific N-QoL total score', 'long-term efficacy, quality of life (QoL), and safety', 'Adverse events (AEs', 'ISI', 'change from baseline in number of nocturnal voids, time to first awakening to void, and QoL assessments (nocturia-specific zQoL [N-QoL], Insomnia Severity Index [ISI], and Hsu bother score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]",503.0,0.0589916,"Changes from baseline above or approximating a clinically meaningful improvement were seen by week 52 in the disease-specific N-QoL total score (improved by 11.5-22.6), ISI (improved by -3.9 to -7.1), and Hsu bother scores (improved by -1.5 to -2.0).","[{'ForeName': 'Kristian V', 'Initials': 'KV', 'LastName': 'Juul', 'Affiliation': 'Ferring International Pharmascience Center, Copenhagen, Denmark.'}, {'ForeName': 'Fredrik L', 'Initials': 'FL', 'LastName': 'Andersson', 'Affiliation': 'Ferring International Pharmascience Center, Copenhagen, Denmark.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Lower Urinary Tract Symptom Research, Nihon University School of Engineering, Koriyama, Japan.'}]",Lower urinary tract symptoms,['10.1111/luts.12347']
2557,32914639,"Evaluation of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after Stroke trial: descriptive analysis of intervention fidelity, goal selection and goal achievement.","OBJECTIVE


To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved.
DESIGN


Descriptive analysis of data on fidelity, goal selection and achievement from an intervention group within a randomized controlled trial.
SETTING


Out-patient stroke rehabilitation within four UK NHS centres.
SUBJECTS


259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0-39) between one week and five years post first stroke.
INTERVENTION


The enhanced upper limb therapy programme aimed to provide 36 one-hour sessions, including 45 minutes of face-to-face therapy focusing on personal goals, over 12 weeks.
RESULTS


7877/9324 (84%) sessions were attended; a median of 34 [IQR 29-36] per participant. A median of 127 [IQR 70-190] repetitions were achieved per participant per session attended. Based upon the Canadian Occupational Performance Measure, goal categories were: self-care 1449/2664 (54%); productivity 374/2664 (14%); leisure 180/2664 (7%) and 'other' 661/2664 (25%). For the 2051/2664 goals for which data were available, 1287 (51%) were achieved, ranging between 27% by participants more than 12 months post stroke with baseline Action Research Arm Test scores 0-7, and 88% by those less than three months after stroke with scores 8-19.
CONCLUSIONS


Intervention fidelity was high. Goals relating to self-care were most commonly selected. The proportion of goals achieved varied, depending on time post stroke and baseline arm activity limitation.",2020,"OBJECTIVE


To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved.
","['259 participants with moderate-severe upper limb activity limitation (Action Research Arm Test 0-39) between one\u2009week and five\u2009years post first stroke', 'Out-patient stroke rehabilitation within four UK NHS centres']",[],[],"[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0579116', 'cui_str': 'Upper limb activities'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],[],259.0,0.0631312,"OBJECTIVE


To report the fidelity of the enhanced upper limb therapy programme within the Robot-Assisted Training for the Upper Limb after stroke (RATULS) randomized controlled trial, the types of goals selected and the proportion of goals achieved.
","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bosomworth', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rodgers', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Aird', 'Affiliation': 'Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Wilson', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Alvarado', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Sreeman', 'Initials': 'S', 'LastName': 'Andole', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'London North West Healthcare NHS Trust, Northwick Park, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernandez-Garcia', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Finch', 'Affiliation': 'Nursing, Midwifery & Health, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Medical Sciences Division, University of Oxford, and Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Francis', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hogg', 'Affiliation': 'Lay investigator (contact Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Niall', 'Initials': 'N', 'LastName': 'Hughes', 'Affiliation': 'NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Duncan L', 'Initials': 'DL', 'LastName': 'Turner', 'Affiliation': 'School of Health, Sport and Bioscience, University of East London, London, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Vale', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, University of Sunderland, Sunderland, UK.'}, {'ForeName': 'Hermano I', 'Initials': 'HI', 'LastName': 'Krebs', 'Affiliation': 'Massachusetts Institute of Technology, Cambridge, USA.'}, {'ForeName': 'Frederike', 'Initials': 'F', 'LastName': 'van Wijck', 'Affiliation': 'School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}]",Clinical rehabilitation,['10.1177/0269215520953833']
2558,32910717,"IL-2  and  IL-2R  gene polymorphisms and immune function in people residing in areas with high background radiation, Yangjiang, China.","Purpose  Long-term exposure to low dose radiation may trigger immune response and stimulate hormesis. Interleukin-2 ( IL-2 ) and interleukin-2 receptor ( IL-2R ) play a crucial role in immune function. We aimed to explore the possible association of  IL-2  and  IL-2R  gene polymorphisms with low dose radiation exposure, as well as the relationship with  IL-2  gene expression in people residing in areas with a high background radiation in Yangjiang, China. Materials and methods  We recruited and assigned 54 native men residing in Yangxi County, Yangjiang city to the high natural background radiation (HNBR) group, and 53 native men residing in Hengpi County, Enping city to the control area (CA) group. All the participants wore a thermoluminescent dosimeter (TLD) for 90 days, and answered questionnaires. The serum levels of IL2, IL4, IL5, sIL2R, and tumor growth factor (TGF), and expression levels of  IL2RA ,  IL2RB ,  IL2RG , and  IL2  were also analyzed. Additionally, we tested 10 polymorphic loci associated with the  IL-2  gene. Results  The annual effective radiation doses in the HNBR and CA groups were 6.24 mSv y -1  and 1.95 mSv y -1 , respectively. After adjusting for potential confounding factors, the serum levels of  IL-2  and  IL-5  were higher in the HNBR group than the CA group ( р <0.05), while the serum level of  TGFβ  was lower in the HNBR group ( р <0.05). The  IL-2  gene mRNA expression level was higher in the HNBR group than the CA group ( p  < 0.05). The  IL-2RB  rs76206423 AA allele showed significant variations in the HNBR group (p = 0.0381). Conclusions  Long-term exposure to low dose radiation may enhance immune function, and  IL-2RB  rs76206423 may be related to the expression of  IL-2  by other coding variants. Moreover, our data provide a better understanding of the molecular mechanism of the immune response to low dose radiation.",2020,The  IL-2  gene mRNA expression level was higher in the HNBR group than the CA group ( p  < 0.05).,"['people residing in areas with a high background radiation in Yangjiang, China', '54 native men residing in Yangxi County, Yangjiang city to the high natural background radiation (HNBR) group, and 53 native men residing in Hengpi County, Enping city to the control area (CA) group', 'people residing in areas with high background radiation, Yangjiang, China']",['Interleukin-2 ( IL-2 ) and interleukin-2 receptor ( IL-2R '],"['IL-2  gene mRNA expression level', 'serum levels of  IL-2  and  IL-5', 'serum level of  TGFβ', 'serum levels of IL2, IL4, IL5, sIL2R, and tumor growth factor (TGF), and expression levels of  IL2RA ,  IL2RB ,  IL2RG , and  IL2']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004607', 'cui_str': 'Background radiation'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C1700887', 'cui_str': 'IL2RA protein, human'}, {'cui': 'C1259013', 'cui_str': 'IL2RB protein, human'}, {'cui': 'C1568975', 'cui_str': 'IL2RG protein, human'}]",54.0,0.0344582,The  IL-2  gene mRNA expression level was higher in the HNBR group than the CA group ( p  < 0.05).,"[{'ForeName': 'Cuiu', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Shibiao', 'Initials': 'S', 'LastName': 'Su', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Rongzong', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Haijuan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Huifeng', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}, {'ForeName': 'Tianjian', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangdong, China.'}]",International journal of radiation biology,['10.1080/09553002.2020.1820607']
2559,32910720,Predicting Response to Vocabulary Intervention Using Dynamic Assessment.,"Purpose The purpose of this study was to examine how well students' response to a morphological vocabulary intervention can be predicted before the start of the intervention from traditional static assessments and to determine whether a dynamic assessment with graduated prompts improves the prediction. Method A planned secondary analysis of a randomized trial of a morphological vocabulary intervention for fifth-grade students with limited vocabulary was conducted. Response to this intervention was examined for 111 participants based on their development in definitions of morphologically transparent words from pretest to posttest. Traditional static measures of vocabulary, knowledge of morphology, and morphological analysis as well as a dynamic assessment of morphological analysis were evaluated as predictors of students' response to intervention. Results The static pretest measures predicted more than half of the overall variance in students' response to intervention and provided a good classification of students with subsequent poor or good response to intervention. The single best static predictor was the static assessment of morphological analysis. Furthermore, the dynamic assessment added significantly to the prediction of the overall variance in students' response to intervention and to the correct early classification of students as poor or good responders. Conclusions The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures. This study also provides evidence for the added predictive value of a dynamic assessment of morphological analysis.",2020,The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures.,"['111 participants based on their development in definitions of morphologically transparent words from pretest to posttest', 'fifth-grade students with limited vocabulary was conducted']",['morphological vocabulary intervention'],"['Traditional static measures of vocabulary, knowledge of morphology, and morphological analysis']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",111.0,0.0206373,The results suggest that an acceptable level of prediction of students' response to morphological vocabulary intervention can be obtained by means of a couple of static morphological measures.,"[{'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Gellert', 'Affiliation': 'Department of Nordic Studies and Linguistics, University of Copenhagen, Denmark.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Arnbak', 'Affiliation': 'Danish School of Education, Aarhus University, Denmark.'}]","Language, speech, and hearing services in schools",['10.1044/2020_LSHSS-20-00045']
2560,32910735,Validation of a Novel Wearable Electromyography Patch for Monitoring Submental Muscle Activity During Swallowing: A Randomized Crossover Trial.,"Purpose Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes. Method A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired  t  tests and descriptive statistics were used to examine safety/preclinical factors. Results Forty healthy adults participated (24 women,  M   age  = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes ( p  < .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml:  p  < .025; 10 ml:  p  < .0012), and sEMG burst duration was also equivalent (5 ml:  p  < .0001; 10 ml:  p  < .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch ( p  = .0476,  d  = 0.226). Conclusions Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia. Supplemental Material https://doi.org/10.23641/asha.12915509.",2020,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","['During Swallowing', 'Forty healthy adults participated (24 women,  M   age  = 67.5 years', 'patients with dysphagia', 'healthy older adults']","['Surface electromyography (sEMG', 'sEMG patch with conventional (snap-on) sEMG electrodes', 'Novel Wearable Electromyography Patch']","['sEMG burst duration', 'normalized amplitude values', 'Safety/preclinical factors', 'mild adverse effects', 'signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort', 'Participant satisfaction', 'Monitoring Submental Muscle Activity', 'safety, efficiency, and signal quality']","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",40.0,0.0897228,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p  < .0001).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Kantarcigil', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Min Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Taehoo', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'School of Materials Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Chi Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Malandraki', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00171']
2561,32910813,High-dose leucine supplementation does not prevent muscle atrophy or strength loss over 7 days of immobilization in healthy young males.,"BACKGROUND


Unavoidable periods of disuse lead to muscle atrophy and functional decline. Preventing such declines can reduce the risk of re-injury and improve recovery of normal physiological functioning.
OBJECTIVES


We aimed to determine the effectiveness of high-dose leucine supplementation on muscle morphology and strength during 7 d of unilateral lower-limb immobilization, and the role of myofibrillar (MyoPS) and mitochondrial (MitoPS) protein synthesis in disuse atrophy.
METHODS


Sixteen healthy males (mean ± SEM age: 23 ± 1 y) underwent 7 d of unilateral lower-limb immobilization, with thrice-daily leucine (LEU; n = 8) or placebo (PLA; n = 8) supplementation (15 g/d). Before and after immobilization, muscle strength and compartmental tissue composition were assessed. A primed continuous infusion of l-[ring-13C6]-phenylalanine with serial muscle biopsies was used to determine postabsorptive and postprandial (20 g milk protein) MyoPS and MitoPS, fiber morphology, markers of protein turnover, and mitochondrial function between the control leg (CTL) and the immobilized leg (IMB).
RESULTS


Leg fat-free mass was reduced in IMB (mean ± SEM: -3.6% ± 0.5%; P = 0.030) but not CTL with no difference between supplementation groups. Isometric knee extensor strength declined to a greater extent in IMB (-27.9% ± 4.4%) than in CTL (-14.3% ± 4.4%; P = 0.043) with no difference between groups. In response to 20 g milk protein, postprandial MyoPS rates were significantly lower in IMB than in CTL (-22% ± 4%; P < 0.01) in both LEU and PLA. Postabsorptive MyoPS rates did not differ between legs or groups. Postabsorptive MitoPS rates were significantly lower in IMB than in CTL (-14% ± 5%; P < 0.01) and postprandial MitoPS rates significantly declined in response to 20 g milk protein ingestion (CTL: -10% ± 8%; IMB: -15% ± 10%; P = 0.039), with no differences between legs or groups. There were no significant differences in measures of mitochondrial respiration between legs, but peroxisome proliferator-activated receptor γ coactivator 1-α and oxidative phosphorylation complex II and III were significantly lower in IMB than in CTL (P < 0.05), with no differences between groups.
CONCLUSIONS


High-dose leucine supplementation (15 g/d) does not appear to attenuate any functional declines associated with 7 d of limb immobilization in young, healthy males.This trial was registered at clinicaltrials.gov as NCT03762278.",2020,Isometric knee extensor strength declined to a greater extent in IMB (-27.9% ± 4.4%) than in CTL (-14.3% ± 4.4%; P = 0.043) with no difference between groups.,"['Sixteen healthy males (mean\xa0±', 'healthy young males']","['l-[ring-13C6]-phenylalanine', 'leucine supplementation', 'High-dose leucine supplementation', 'unilateral lower-limb immobilization, with thrice-daily leucine (LEU; n\xa0=\xa08) or placebo (PLA; n\xa0=\xa08) supplementation']","['muscle morphology and strength', 'IMB', 'Isometric knee extensor strength', 'muscle strength and compartmental tissue composition', 'postprandial MitoPS rates', 'mitochondrial respiration between legs, but peroxisome proliferator-activated receptor γ coactivator 1-α and oxidative phosphorylation complex II and III', 'Postabsorptive MitoPS rates', 'postprandial MyoPS rates', 'Postabsorptive MyoPS rates', 'muscle atrophy or strength loss']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0030013', 'cui_str': 'Oxidative phosphorylation'}, {'cui': 'C1453024', 'cui_str': 'SDHD protein, human'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C3714552', 'cui_str': 'Debility'}]",16.0,0.02279,Isometric knee extensor strength declined to a greater extent in IMB (-27.9% ± 4.4%) than in CTL (-14.3% ± 4.4%; P = 0.043) with no difference between groups.,"[{'ForeName': 'Sophie J', 'Initials': 'SJ', 'LastName': 'Edwards', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Smeuninx', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mckendry', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Nishimura', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ryan N', 'Initials': 'RN', 'LastName': 'Marshall', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Perkins', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ramsay', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Joanisse', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Philp', 'Affiliation': 'Garvan Institute of Medical Research, Sydney, New South Wales, Australia.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Breen', 'Affiliation': 'School of Sport, Exercise, and Rehabilitation Sciences, University of Birmingham, Birmingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa229']
2562,32911214,Cognitive behavioral therapy for persons living with HIV in China: A randomized pilot trial.,"BACKGROUND


Chinese persons living with HIV (PLWH) suffer from prevalent mental health issues. We aimed to develop a tailored cognitive behavioral therapy (CBT), test its feasibility, acceptability, and preliminary effects (depression, anxiety, and medication adherence) for Chinese PLWH.
METHODS


Twenty PLWH were assigned randomly. Intervention participants learned skills in CBT and relaxation training in a tailored group-based weekly 10-session project. Each session lasted for two hours and was delivered by nurses and volunteers. Control participants only received laboratory tests and free antiretroviral therapy (ART) medication. Feasibility and acceptability were descriptively summarized. Depression, anxiety, and ART medication adherence data were collected at the baseline (T0), after the intervention (T1) and after 6 months of follow-up (T2).
RESULTS


The average CBT attendance rate for all sessions was 60%. No participants in the intervention group dropped out of the study. All participants in the intervention group agreed that they could benefit from the CBT. Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1. However, no preliminary intervention effect was found at T2.
LIMITATIONS


The small sample size leads to a lack of representativeness in the study sample. We excluded participants with severe comorbidities, which may lead to an underestimate of the intervention effect of CBT among Chinese PLWH.
CONCLUSIONS


CBT is feasible and acceptable, demonstrating promising preliminary effects on anxiety and ART medication adherence among Chinese PLWH. Additional research is needed to test the effectiveness of this approach.",2020,Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1.,"['Twenty PLWH', 'persons living with HIV in China', 'Chinese persons living with HIV (PLWH', 'participants with severe comorbidities, which may lead to an underestimate of the intervention effect of CBT among Chinese PLWH']","['CBT', 'CBT and relaxation training', 'tailored cognitive behavioral therapy (CBT', 'Cognitive behavioral therapy', 'laboratory tests and free antiretroviral therapy (ART) medication']","['average CBT attendance rate', 'Feasibility and acceptability', 'anxiety and self-reported ART medication adherence', 'feasibility, acceptability, and preliminary effects (depression, anxiety, and medication adherence', 'Depression, anxiety, and ART medication adherence data', 'anxiety and ART medication adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",20.0,0.0619608,Participants in the intervention group showed a greater improvement in anxiety and self-reported ART medication adherence than those in the control group at T1.,"[{'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China. Electronic address: huyan@fudan.edu.cn.'}, {'ForeName': 'Hongzhou', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Shanghai Public Health Clinical Center Affiliated with Fudan University, Shanghai 201508, China. Electronic address: luhongzhou@shphc.org.cn.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Public Health Clinical Center Affiliated with Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'School of Nursing, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'School of Public Health, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Relf', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke Global Health Institute, Duke University, Durham, USA.'}, {'ForeName': 'Yaolin', 'Initials': 'Y', 'LastName': 'Pei', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, USA.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.085']
2563,32911242,The effectiveness of a preoperative multi-component non-pharmacologic preparation on post-tonsillectomy pain: A randomized controlled clinical trial.,"INTRODUCTION


Tonsillectomy is a painful operation and some studies have suggested that preoperative non-pharmacologic preparations may decrease postoperative pain. In this randomized clinical trial study, we decided to determine which is more effective in the post-tonsillectomy pain; an informative booklet or a costly, time consuming, sophisticated, and multi-component preparation program.
MATERIALS AND METHODS


Patients were randomly assigned into two groups. In the booklet group, children and their parents only received an informative booklet as routine information preparation. On the other hand, in the multi-component group; in addition to receiving the same booklet, children and their parents received our multi-component pre-operative preparation program. The following items were included in the package: preoperative tour in the ward, an educational DVD, and therapeutic play intervention. All patients were observed at least for 8 h as a day case or ambulatory tonsillectomy. The pain score was recorded according to the visual analog scale for seven days. Finally, the post-tonsillectomy pain scores were compared in the two groups. The multi-component group included 121 children and booklet group 120.
RESULTS


Minimum and maximum age was 9 and 12 years. Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
CONCLUSION


Our data revealed that a new concept which is more cost-effective and concise booklet is as effective as costly and sophisticated methods in post-tonsillectomy pain among 9-12 years old children.",2020,"Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
","['post-tonsillectomy pain', '121 children and booklet group 120', '9-12 years old children', 'Patients']",['preoperative multi-component non-pharmacologic preparation'],"['pain score', 'tonsillectomy pain scores', 'postoperative pain']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",121.0,0.0305591,"Regarding post-tonsillectomy pain, we found no significant difference between the multi-component group and the booklet group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: faramarzi@sums.ac.ir.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Roosta.Sareh@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Faramarzi', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: ali_faramarzi@sums.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Salehi', 'Affiliation': 'Research Center for Traditional Medicine and History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: salehiar@sums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Matani', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: inasmeh@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110359']
2564,32911306,Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: Results from the TOWER extension study.,"BACKGROUND


In the phase 3 TOWER core study (NCT00751881), the efficacy and safety of teriflunomide compared with placebo were demonstrated in patients with relapsing forms of multiple sclerosis (RMS). Here, the long-term safety and efficacy outcomes from the TOWER extension study (NCT00751881) are reported.
METHODS


All patients who entered the extension (N = 751) were assigned to teriflunomide 14 mg and assessed for long-term safety and efficacy.
RESULTS


Of 751 patients in the TOWER extension study, 253, 265, and 233 patients received placebo/teriflunomide 14 mg, teriflunomide 7 mg/14 mg, and teriflunomide 14 mg/14 mg, respectively. Median teriflunomide exposure was 4.25 years (maximum 6.3 years). The overall frequency of adverse events (AEs) was comparable across treatment groups, but a higher proportion of patients in the teriflunomide 7 mg/14 mg (12.4%) and 14 mg/14 mg (12.4%) groups had serious AEs compared with the placebo/teriflunomide 14 mg group (6.4%). Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively). The incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy) were low and comparable across treatment arms. Disability worsening and adjusted annualized relapse rates were low and stable over time, and mean Expanded Disability Status Scale scores were unchanged over time, for all treatment groups.
CONCLUSION


In the TOWER extension study, the efficacy of teriflunomide 14 mg was maintained in patients with RMS. No new or unexpected AEs were observed with teriflunomide treatment, supporting a safety profile in the extension that was consistent with the core trial. These findings support the positive benefit:risk profile of teriflunomide as a long-term immunomodulatory therapy.",2020,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","['All patients who entered the extension', '751 patients in the TOWER extension study, 253, 265, and 233 patients received', 'patients with relapsing forms of multiple sclerosis (RMS', 'patients with relapsing multiple sclerosis', 'patients with RMS']","['placebo/teriflunomide 14\xa0mg, teriflunomide', 'placebo', 'placebo/teriflunomide', 'teriflunomide']","['incidences of AEs of interest (hematologic and hepatic effects, peripheral neuropathy, hypertension, and malignancy', 'efficacy and safety', 'Disability worsening and adjusted annualized relapse rates', 'Median teriflunomide exposure', 'mean Expanded Disability Status Scale scores', 'Alanine aminotransferase increase and hair thinning', 'overall frequency of adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3497716', 'cui_str': 'teriflunomide 14 MG'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0020678', 'cui_str': 'Hypotrichosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",751.0,0.0571361,"Alanine aminotransferase increase and hair thinning occurred at a higher frequency in the placebo/teriflunomide 14 mg group (11.2% and 14.3%, respectively) compared with the teriflunomide 7 mg/14 mg (3.0% and 4.5%, respectively) and 14 mg/14 mg groups (5.2% and 4.3%, respectively).","[{'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 East 98th Street-Box 1138, New York, NY, 10029, United States. Electronic address: aaron.miller@mssm.edu.'}, {'ForeName': 'Tomas P', 'Initials': 'TP', 'LastName': 'Olsson', 'Affiliation': 'Neuroimmunology Unit, Department of Clinical Neuroscience, Karolinska Institutet, Center for Molecular Medicine, L8:04, Karolinska Hospital, 17176 Stockholm, Sweden.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), 6431 Fannin Street, Houston, TX, 77030, United States.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland.'}, {'ForeName': 'Xueqiang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Neurology, Hospital of Sun Yat-Sen University, 107 Yan Jiang West Road, Guangzhou, China.'}, {'ForeName': 'Xianhao', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Hospital, No. 1 Dahua Road, Beijing, China.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Lublin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Chavin', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Delhay', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Purvis', 'Affiliation': 'Sanofi, Cambridge, MA, United States.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The Ottawa Hospital Ontario, 501 Smyth Road, Box 601, Ottawa, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102438']
2565,32911319,"A randomized pilot study assessing the acceptability of rapid point-of-care hepatitis C virus (HCV) testing among male inmates in Montreal, Canada.","BACKGROUND


The Oraquick Ⓡ  fingerprick point-of-care hepatitis C virus antibody (HCV-Ab) test is favoured to venipuncture among people who inject drugs; however, its acceptability in prison populations is unknown. We aimed to compare the acceptability of the Oraquick Ⓡ  versus standard venipuncture among people in prison.
METHODS


From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation. The remaining 78 were randomized 1:1 to opt-out HCV-Ab screening with OraQuick Ⓡ  or venipuncture (n = 39 each). Acceptability was determined by the proportion accepting to undergo screening.
RESULTS


The majority of participants (median age 33 years) reported a history of drug use (76%; 8% injection drug use); 47% perceived their HCV risk to be moderate/high. All inmates randomized to Oraquick Ⓡ  accepted testing while 87% accepted venipuncture. Among those who accepted Oraquick Ⓡ  vs. venipuncture, 100% vs. 97% were satisfied with the test, 97% vs. 94% would recommend the same test, and 100% vs. 76% would choose the same test again.
CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.",2020,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[""From October to December 2019, 280 sentenced male inmates at L'Établissement de Détention de Montréal (Quebec, Canada) were screened for participation, 150 excluded due to prior HCV screening, and 52 refused participation"", 'people in prison', 'male inmates in Montreal, Canada', 'Adult incarcerated men in Canada']","['rapid point-of-care hepatitis C virus (HCV', 'venipuncture', 'Ⓡ  or venipuncture', 'HCV-Ab screening with OraQuick', 'Oraquick Ⓡ  versus standard venipuncture']",['Acceptability'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",280.0,0.0431789,"CONCLUSION


Adult incarcerated men in Canada were both more likely to accept Oraquick Ⓡ  compared to venipuncture, and to choose Oraquick Ⓡ  for future HCV screening.","[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Kronfli', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: nadine.kronfli@mcgill.ca.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Dussault', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chalifoux', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Hasmig', 'Initials': 'H', 'LastName': 'Kavoukian', 'Affiliation': 'Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Marina B', 'Initials': 'MB', 'LastName': 'Klein', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; CIHR Canadian HIV Trials Network, Vancouver, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases and Chronic Viral Illness Service, McGill University, Montreal, Quebec, Canada; Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102921']
2566,32915027,Mindfulness-oriented recovery enhancement reduces opioid dose in primary care by strengthening autonomic regulation during meditation.,"The current opioid crisis was fueled by escalation of opioid dosing among patients with chronic pain. Yet, there are few evidence-based psychological interventions for opioid dose reduction among chronic pain patients treated with long-term opioid analgesics. Mindfulness-Oriented Recovery Enhancement (MORE), which was designed to target mechanisms underpinning chronic pain and opioid misuse, has shown promising results in 2 randomized clinical trials (RCTs) and could facilitate opioid sparing and tapering by bolstering self-regulation. Here we tested this hypothesis with secondary analyses of data from a Stage 2 RCT. Chronic pain patients (N = 95) on long-term opioid therapy were randomized to 8 weeks of MORE or a support group (SG) control delivered in primary care. Opioid dose was assessed with the Timeline Followback through 3-month follow-up. Heart rate variability (HRV) during mindfulness meditation was quantified as an indicator of self-regulatory capacity. Participants in MORE evidenced a greater decrease in opioid dosing (a 32% decrease) by follow-up than did the SG, F(2, 129.77) = 5.35, p = .006, d = 1.07. MORE was associated with a significantly greater increase in HRV during meditation than was the SG. Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034). MORE may boost self-regulatory strength via mindfulness and thereby facilitate self-control over opioid use, leading to opioid dose reduction in people with chronic pain. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"['people with chronic pain', 'chronic pain patients treated with long-term opioid analgesics', 'Chronic pain patients (N = 95) on long-term opioid therapy', 'patients with chronic pain']","['MORE or a support group (SG) control delivered in primary care', 'Mindfulness-Oriented Recovery Enhancement (MORE']","['Heart rate variability (HRV', 'HRV']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.0780555,Meditation-induced change in HRV partially mediated the effect of MORE on opioid dose reduction (p = .034).,"[{'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Hudak', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah.'}]",The American psychologist,['10.1037/amp0000638']
2567,32915043,The effects of cognitive processing therapy + hypnosis on objective sleep quality in women with posttraumatic stress disorder.,"Objective:  Insomnia, characterized by difficulty falling and staying asleep, is a common and debilitating symptom of posttraumatic stress disorder (PTSD) that is resistant to first-line, trauma-focused therapies. Previous research has found that sleep-directed hypnosis improves subjective sleep quality, particularly sleep onset latency, in women with PTSD. However, it cannot be assumed that improvements in subjective sleep reports correspond with objectively measured sleep improvements, because research has indicated a lack of agreement across these measures. The current study examined the effects of sleep-directed hypnosis plus cognitive processing therapy (hypCPT) on objective indices of sleep quality measured with actigraphy.  Method:  Forty-five women with PTSD were randomized to receive sleep-directed hypCPT or sleep and psychiatric symptom monitoring plus CPT (ssmCPT). Pre- and posttreatment, participants completed 1 week of daily actigraphy assessments of nocturnal sleep onset latency, waking after sleep onset, and total sleep time.  Results:  Overall improvement in objective sleep indices was not observed. Despite this, at posttreatment, treatment completers receiving hypCPT took significantly less time to fall asleep than did women receiving ssmCPT.  Conclusions:  More research is needed to understand and reduce the discrepancy between subjectively and objectively assessed sleep impairments in PTSD. Nevertheless, results indicate that adding sleep-directed hypnosis to trauma-focused therapy may be of some use for individuals with PTSD-related insomnia. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Despite this, at posttreatment, treatment completers receiving hypCPT took significantly less time to fall asleep than did women receiving ssmCPT.  ","['women with PTSD', 'individuals with PTSD-related insomnia', 'women with posttraumatic stress disorder', 'Method:  Forty-five women with PTSD']","['hypCPT', 'cognitive processing therapy + hypnosis', 'sleep-directed hypnosis plus cognitive processing therapy (hypCPT', 'sleep-directed hypCPT or sleep and psychiatric symptom monitoring plus CPT (ssmCPT']","['subjective sleep quality', 'time to fall asleep', 'objective sleep quality', 'objective sleep indices', 'sleep quality', 'nocturnal sleep onset latency, waking after sleep onset, and total sleep time']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319567', 'cui_str': '45'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",45.0,0.0237354,"Despite this, at posttreatment, treatment completers receiving hypCPT took significantly less time to fall asleep than did women receiving ssmCPT.  ","[{'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Arditte Hall', 'Affiliation': 'Department of Psychology and Philosophy.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Werner', 'Affiliation': 'Missouri Institute of Mental Health.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Griffin', 'Affiliation': 'Center for Trauma Recovery.'}, {'ForeName': 'Tara E', 'Initials': 'TE', 'LastName': 'Galovski', 'Affiliation': 'VA National Center for PTSD.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000970']
2568,32915053,Comparison of the Finger Feeding Method Versus Syringe Feeding Method in Supporting Sucking Skills of Preterm Babies.,"Aim:  The aim of this study is to compare the efficiency of a new method called ""finger feeding"" with a well-known technique called syringe feeding for improving sucking skills and accelerating transition to breastfeeding in preterm infants.  Materials and Methods:  Totally 70 babies were included in this prospective randomized controlled study. Finger feeding method was applied in Group 1 ( n  = 35) and syringe feeding method was applied in Group 2 ( n  = 35). The COMFORTneo scale (CnS), oxygen saturation, pulse, respiratory rate, body temperature, amount of breast milk taken, and vomiting data were recorded before and after both applications. Hospitalization period and time elapsed for complete transition from both methods to breastfeeding were also recorded.  Results:  There was no statistical difference for birth weights, mean gestational age, and vital signs recorded before and after feeding between two groups. Predicted comfort and distress scores of Group 1 determined by the CnS were significantly lower than those of Group 2. This means that babies in the finger feeding group had better comfort than the those in Group 2 ( p  = 0.000). Time passed for transition to breastfeeding was significantly shorter than that in Group 2 (19.4 ± 15.0 days versus 29.7 ± 10.2 days,  p  = 0.000). Group 1 had lower amount of food leakage while feeding and their average weight gain at the end of 10th day was significantly higher (322.1 ± 82.3 g versus 252 ± 108.4 g,  p  = 0.004). They also were discharged earlier than Group 2 (25.8 ± 17.4 days versus 35.9 ± 13.0 days,  p  = 0.001).  Conclusion:  Finger feeding method is an effective way for increasing sucking abilities, accelerating transition to breastfeeding, and shortens duration of hospitalization in preterm infants.",2020,"There was no statistical difference for birth weights, mean gestational age, and vital signs recorded before and after feeding between two groups.","['70 babies', 'preterm infants', 'Preterm Babies']",[],"['COMFORTneo scale (CnS), oxygen saturation, pulse, respiratory rate, body temperature, amount of breast milk taken, and vomiting data', 'birth weights, mean gestational age, and vital signs', 'food leakage while feeding and their average weight gain', 'Predicted comfort and distress scores', 'Time passed for transition to breastfeeding']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]",70.0,0.0175237,"There was no statistical difference for birth weights, mean gestational age, and vital signs recorded before and after feeding between two groups.","[{'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Buldur', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Nalan', 'Initials': 'N', 'LastName': 'Yalcin Baltaci', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Demet', 'Initials': 'D', 'LastName': 'Terek', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yalaz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Altun Koroglu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Mete', 'Initials': 'M', 'LastName': 'Akisu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Nilgun', 'Initials': 'N', 'LastName': 'Kultursay', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Ege University, Faculty of Medicine, Izmir, Turkey.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0043']
2569,32915093,EFFECT OF MODERATE ACTIVITY ON LIVER FUNCTION AND SERUM LIPID LEVEL IN HEALTHY SUBJECTS DURING THE PHASE I CLINICAL TRIAL.,"BACKGROUND


This study aims to investigate the incidence of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and triglyceride (TG) elevation, and the relationship with the phase I unit effect, and the moderate activity in healthy subjects enrolled in Phase I clinical trials.
METHODS


The demographic, AST, ALT, TG and activity data were collected from the placebo (146 subjects) groups and tested drug (885 subjects) groups in 20 phase I trials.
RESULTS


Elevated AST, ALT and TG levels above the upper limit of normal were detected in 1.37%, 4.79% and 34.7% of subjects in the placebo group, respectively, 3.73%, 6.67% and 39.2% of subjects in the tested drug group, respectively. The incidence of elevated AST, ALT and TG increased with the extended hospital stay. However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay. The logistic regression analysis revealed that the baseline AST and ALT level, female gender, moderate exercise and duration of hospital stay were independent risk factors for ALT elevation.
CONCLUSION


Moderate exercise during hospital stay may reduce the elevation rate of transaminases, but not TG, in subjects at phase I trials.",2020,"However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay.","['healthy subjects enrolled in Phase I clinical trials', '146 subjects) groups and tested drug (885 subjects) groups in 20 phase I trials']","['TG', 'placebo']","['levels above the upper limit of normal', 'baseline AST and ALT level, female gender, moderate exercise and duration of hospital stay', 'incidence of elevated AST, ALT and TG', 'aspartate aminotransferase (AST), alanine aminotransferase (ALT) and triglyceride (TG) elevation', 'elevation rate of transaminases', 'demographic, AST, ALT, TG and activity data']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0282459', 'cui_str': 'Clinical Trial, Phase 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151904', 'cui_str': 'Aspartate aminotransferase increased'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0553448,"However, the incidence of elevated AST and ALT, but not the elevated TG, was reduced in subjects with moderate exercise during their hospital stay.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China 130021.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China 130021.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China 130021.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China 130021.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University , Changchun, Jilin, China 130021.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1823369']
2570,32915158,Motivation Predicts Change in Nurses' Physical Activity Levels During a Web-Based Worksite Intervention: Results From a Randomized Trial.,"BACKGROUND


Low physical activity levels can negatively affect the health of nurses. Given the low physical activity levels reported by nurses, there is a clear need for brief and economical interventions designed to increase physical activity levels in this population. We developed a web-based intervention that used motivational strategies to increase nurses' physical activity levels. The intervention provided the nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge.
OBJECTIVE


In this parallel-group randomized trial, we examine whether nurses' motivation at baseline predicted changes in objectively measured physical activity levels during the 6-week intervention.
METHODS


The participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3 physical activity challenge conditions: (1) individual, (2) friend, or (3) team. The nurses completed a web-based questionnaire designed to assess motivational regulations for physical activity levels before the intervention and wore a Tractivity activity monitor before and during the 6-week intervention. We analyzed data using multilevel modeling for repeated measures.
RESULTS


The nurses' physical activity levels increased (linear estimate=10.30, SE 3.15; P=.001), but the rate of change decreased over time (quadratic estimate=-2.06, SE 0.52; P<.001). External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
CONCLUSIONS


Our findings provide evidence that an intervention that incorporates self-monitoring and physical activity challenges can be generally effective in increasing nurses' physical activity levels in the short term. They also suggest that drawing solely on organismic integration theory to predict changes in physical activity levels among the nurses participating in web-based worksite interventions may have been insufficient. Future research should examine additional personal (eg, self-efficacy) and occupational factors (eg, shift length and shift type) that influence physical activity levels to identify potential targets for intervention among nurses.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04524572; https://clinicaltrials.gov/ct2/show/NCT04524572.",2020,"External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
","['participants were 76 nurses (n=74, 97% female; mean age 46, SD 11 years) randomly assigned to 1 of 3']","['nurses with feedback from an activity monitor coupled with a web-based individual, friend, or team physical activity challenge', 'physical activity challenge conditions: (1) individual, (2) friend, or (3) team', 'Worksite Intervention']","[""Nurses' Physical Activity Levels"", ""nurses' physical activity levels"", 'physical activity levels']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",76.0,0.0444141,"External and identified regulations (ß=-2.08 to 11.55; P=.02 to .04), but not intrinsic and introjected regulations (ß=-.91 to 6.29; P=.06 to .36), predicted changes in the nurses' physical activity levels.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Brunet', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Tulloch', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wolfe Phillips', 'Affiliation': 'Faculty of Health Sciences, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Pipe', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Reed', 'Affiliation': 'Division of Prevention and Rehabilitation, University of Ottawa Heart Institute, Ottawa, ON, Canada.'}]",Journal of medical Internet research,['10.2196/11543']
2571,32915162,"Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting.","BACKGROUND


In the United States, young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection. However, racial and ethnic disparities in adolescent HIV infection cannot be attributed to individual-level factors alone and are situated within larger social and structural contexts that marginalize and predispose sexual and gender minority youth of color to HIV. Addressing broader ecological factors that drive transmission requires interventions that focus on the distal drivers of HIV infection, including violence exposure, housing, food insecurity, educational attainment, and employment. Given the ways that economic instability may make YMSM, YTW, and GNC youth of color vulnerable to HIV exposure, this study focuses on employment as an HIV prevention intervention. More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness. The intervention was adapted from iFOUR, an evidence-based employment program for HIV-positive adults in phase 1 of this study, and pilot tested in a university-based setting in phase 2.
OBJECTIVE


This paper aims to describe the protocol for the community-based test phase of W2P. The purpose of this phase was to pilot test a tailored, theoretically informed employment intervention program among YMSM, YTW, and GNC youth of color within a lesbian, gay, bisexual, transgender, and queer (LGBTQ) community setting.
METHODS


The employment intervention was pilot tested using a single-arm pretest-posttest trial design implemented among a sample of vulnerable YMSM, YTW, and GNC youth of color using services within a community-based LGBTQ center. Assessments will examine intervention feasibility, acceptability, and preliminary estimates of efficacy.
RESULTS


Phase 3 of W2P research activities began in May 2019 and was completed in December 2019. Overall, 41 participants were enrolled in the community-based pilot.
CONCLUSIONS


This study will assess intervention feasibility and acceptability in the target populations and determine preliminary efficacy of the intervention to increase employment and reduce vulnerability to HIV when implemented in a community-based setting serving LGBTQ youth of color. Testing the intervention in a community setting is an opportunity to evaluate how recruitment, retention, and other outcomes are impacted by delivery in a venue akin to where this intervention could eventually be used by nonresearchers. If W2P demonstrates feasibility and acceptability, a larger multisite trial implemented in multiple community settings serving YMSM, YTW, and GNC youth of color is planned.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03313310; https://clinicaltrials.gov/ct2/show/NCT03313310.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18051.",2020,"More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness.","['young cisgender men who have sex with men (YMSM), young transgender women (YTW), and gender nonconforming (GNC) youth face elevated rates of HIV infection', '41 participants were enrolled in the community-based pilot', 'Young Men', 'Men and Transgender Youth of Color (Phase 3']",['Employment Intervention Program'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],41.0,0.0463592,"More specifically, the intervention, called Work2Prevent (W2P), targets economic stability through job readiness and employment as a means of preventing behaviors and factors associated with adolescent and young adult HIV, such as transactional sex work and homelessness.","[{'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Hill', 'Affiliation': 'Planned Parenthood Great Plains, Overland Park, KS, United States.'}, {'ForeName': 'Darnell N', 'Initials': 'DN', 'LastName': 'Motley', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rosentel', 'Affiliation': 'Center for Interdisciplinary Inquiry and Innovation in Sexual and Reproductive Health, Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, United States.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'VandeVusse', 'Affiliation': 'Guttmacher Institute, New York, NY, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Kuhns', 'Affiliation': ""Division of Adolescent Medicine, Ann & Robert H Lurie Children's Hospital, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, United States.""}, {'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Kipke', 'Affiliation': ""Division of Research on Children, Youth, and Families, Children's Hospital Los Angeles, Los Angeles, CA, United States.""}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Reisner', 'Affiliation': 'Fenway Health, The Fenway Institute, Boston, MA, United States.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Rupp', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'West Goolsby', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'McCumber', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Renshaw', 'Affiliation': 'Collaborative Studies Coordinating Center, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Schneider', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, United States.'}]",JMIR research protocols,['10.2196/18051']
2572,32915346,"Postoperative pain after different irrigation activation techniques: a randomized, clinical trial.","The aim of this study was to assess the effectiveness of irrigation activation techniques on postoperative pain (PP) in mandibular premolar teeth with irreversible pulpitis after single-visit endodontic treatment. A total of 160 patients with symptomatic irreversible pulpitis were included in this prospective randomized clinical study. Four different activation methods were used in mandibular premolar teeth. In group 1, teeth were irrigated with side-port endodontic needles (NI) without any agitation; in groups 2 and 3, sonic activation was performed using EDDY and EndoActivator (EA), respectively; and in group 4, passive ultrasonic irrigation (PUI) was used. Patients' analgesic intake-as well as pain intensity during and after treatment-were recorded at 8, 24, 48 h and 7 days. The data relating to age, sex and analgesic intake was evaluated using the Chi-square test and the preoperative pain and PP intensity at different time intervals was evaluated with the Kruskal-Wallis test at a 5% significance level. Highest PP was recorded at 8 h, pain intensity decreased in all groups by the time. Pain in the NI group was found higher than that of EDDY group at 24 h (P < 0.05). EA and PUI had caused mild pain and had similar pain scores at 24 h. (P > 0.05). No statistically difference was found among the groups with regard to analgesic intake (P > 0.05). Although there were slight differences in PP levels between the groups at 24 h, pain levels decreased in all groups after 24 h. Activation of the irrigation solution did not make any difference in terms of PP after 24 h.",2020,Pain in the NI group was found higher than that of EDDY group at 24 h (P < 0.05).,"['mandibular premolar teeth with irreversible pulpitis after single-visit endodontic treatment', '160 patients with symptomatic irreversible pulpitis']","['side-port endodontic needles (NI) without any agitation', 'irrigation activation techniques', 'passive ultrasonic irrigation (PUI']","['preoperative pain and PP intensity', 'postoperative pain (PP', 'mild pain', 'pain levels', 'analgesic intake', 'pain intensity', 'PP levels', 'Postoperative pain', 'Pain', 'Highest PP', 'pain scores']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",160.0,0.0443264,Pain in the NI group was found higher than that of EDDY group at 24 h (P < 0.05).,"[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Gündoğar', 'Affiliation': 'Faculty of Dentistry, Department of Endodontics, Medipol University, İstanbul, Turkey.'}, {'ForeName': 'Güzide Pelin', 'Initials': 'GP', 'LastName': 'Sezgin', 'Affiliation': 'Faculty of Dentistry, Department of Endodontics, Biruni University, İstanbul, Turkey.'}, {'ForeName': 'Sema Sönmez', 'Initials': 'SS', 'LastName': 'Kaplan', 'Affiliation': 'Faculty of Dentistry, Department of Endodontics, Biruni University, İstanbul, Turkey.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Özyürek', 'Affiliation': 'Faculty of Dentistry, Department of Pedodontics, Kocaeli University, Kocaeli, Turkey.'}, {'ForeName': 'Gülşah', 'Initials': 'G', 'LastName': 'Uslu', 'Affiliation': 'Faculty of Dentistry, Department of Endodontics, Çanakkale Onsekiz Mart University, Çanakkale, Turkey. gulsah.turkkan@hotmail.com.'}, {'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Özyürek', 'Affiliation': 'Faculty of Dentistry, Department of Endodontics, Istanbul Medeniyet, İstanbul, Turkey.'}]",Odontology,['10.1007/s10266-020-00553-5']
2573,32915349,Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study.,"PURPOSE


Antihypertensive treatment is the most important method to reduce the risk of cardiovascular events in hypertensive patients. However, there is scant evidence of the benefits of levoamlodipine maleate for antihypertensive treatment using a head-to-head comparison in the real-world. This study aims to examine the effectiveness of levoamlodipine maleate used to treat outpatients with primary hypertension compared with amlodipine besylate in a real-world setting.
METHODS


This was a pragmatic comparative effectiveness study carried out at 110 centers across China in outpatients with primary hypertension treated with levoamlodipine maleate or amlodipine besylate, with 24 months of follow-up. The primary outcomes used for evaluating the effectiveness were composite major cardiovascular and cerebrovascular events (MACCE), adverse reactions, and cost-effectiveness.
RESULTS


Among the included 10,031 patients, there were 482 MACCE, 223 (4.4%) in the levoamlodipine maleate group (n = 5018) and 259 (5.2%) in the amlodipine besylate group (n = 5013) (adjusted hazard ratio = 0.90, 95%CI: 0.75-1.08, P = 0.252). The levoamlodipine maleate group had lower overall incidences of any adverse reactions (6.0% vs. 8.4%, P < 0.001), lower extremity edema (1.1% vs. 3.0%, P < 0.001) and headache (0.7% vs. 1.1%, P = 0.045). There was a nearly 100% chance of the levoamlodipine maleate being cost-effective at a willingness to pay threshold of 150,000 Yuan per quality-adjusted life years (QALYs) gained, resulting in more QALYs (incremental QALYs: 0.00392) and cost savings (saving 2725 Yuan or 28.8% reduction in overall costs) per patient.
CONCLUSION


In conclusion, levoamlodipine maleate could reduce cost by 29% with a similar MACCE incidence rate and lower occurrence of adverse reactions (especially edema and headache) compared with amlodipine besylate.
TRIAL REGISTRATION


Clinicaltrials.gov NCT01844570 registered at May 1, 2013.",2020,"< 0.001) and headache (0.7% vs. 1.1%, P = 0.045).","['outpatients with primary hypertension', 'in a real-world setting', '110 centers across China in outpatients with primary hypertension treated with', ' with 24\xa0months of follow-up', 'hypertensive patients']","['Levoamlodipine Maleate', 'amlodipine besylate', 'levoamlodipine maleate or amlodipine besylate', 'levoamlodipine maleate', 'Amlodipine Besylate']","['headache', 'lower extremity edema', 'cost savings', 'overall incidences of any adverse reactions', 'adverse reactions (especially edema and headache', 'composite major cardiovascular and cerebrovascular events (MACCE), adverse reactions, and cost-effectiveness']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0354468', 'cui_str': 'Amlodipine besylate'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0239340', 'cui_str': 'Edema of lower extremity'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.120883,"< 0.001) and headache (0.7% vs. 1.1%, P = 0.045).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, 510515, China.'}, {'ForeName': 'Lianyou', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiovascular, Tangdu Hospital, Air Force Military Medical University, Xi'an, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Hua', 'Affiliation': 'Department of Cardiology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yingxian', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Dang', 'Affiliation': 'Department of Special Care Center, National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Pingjin', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Hypertension, Research Center for Hypertension Management and Prevention in Community, Shanghai Key Laboratory of Hypertension, Shanghai Institute of Hypertension, State Key Laboratory of Medical Genomics, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': 'Department of Cardiovascular, The Second Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Luosha', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiovascular, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lianqun', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Cardiology, Shandong Provence Hospital, Jinan, China.'}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Cardiac Medicine, Hebei General Hospital, Shijiazhuang, China.'}, {'ForeName': 'Yinong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Geriatrics, Department of Hypertension, Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Guang'an men Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, The Fifth Central Hospital of Tianjin, Tianjin, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, 100034, China. huoyong@263.net.cn.'}, {'ForeName': 'Pingyan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, 510515, China. chenpy99@126.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07054-1']
2574,32915354,Brief Report: A Randomized Controlled Trial of the Effects of RECALL (Reading to Engage Children with Autism in Language and Learning) for Preschoolers with Autism Spectrum Disorder.,"This study investigated the effects of a parent-implemented dialogic reading approach-Reading to Engage Children with Autism in Language and Learning (RECALL)-on the engagement in reading and inference-making ability for preschoolers with autism spectrum disorder (ASD). Thirty-one preschoolers (mean age = 5.90 years, SD = 0.69; 26 boys, 5 girls) were randomly assigned to a treatment or control group. Six weeks of RECALL significantly enhanced story comprehension, emotion knowledge, and reading engagement among preschoolers in the treatment group. This might be the first randomized controlled trial testing the effects of RECALL on children with ASD. Our findings suggest that additional instructional support such as the application of a prompting hierarchy during dialogic reading might help children with ASD reap greater benefits from shared book reading.",2020,"Six weeks of RECALL significantly enhanced story comprehension, emotion knowledge, and reading engagement among preschoolers in the treatment group.","['preschoolers with autism spectrum disorder (ASD', '5.90\xa0years, SD\u2009=\u20090.69; 26 boys, 5 girls', 'Thirty-one preschoolers (mean age\u2009', 'children with ASD', 'Preschoolers with Autism Spectrum Disorder']","['RECALL ', 'Language and Learning', 'parent-implemented dialogic reading approach-Reading']","['story comprehension, emotion knowledge, and reading engagement']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",31.0,0.0478193,"Six weeks of RECALL significantly enhanced story comprehension, emotion knowledge, and reading engagement among preschoolers in the treatment group.","[{'ForeName': 'Jennie Ying Tung', 'Initials': 'JYT', 'LastName': 'Lo', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong, China.'}, {'ForeName': 'Kathy Kar-Man', 'Initials': 'KK', 'LastName': 'Shum', 'Affiliation': 'Department of Psychology, The University of Hong Kong, Pokfulam Road, Hong Kong, China. kkmshum@hku.hk.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04692-0']
2575,32915370,Effects of anesthetics on microvascular reactivity measured by vascular occlusion tests during off-pump coronary artery bypass surgery: a randomized controlled trial.,"Microvascular function may be modulated by various anesthetics. Desflurane and propofol anesthesia have different effects on microvascular function. However, there are few reports on the effects of sevoflurane and desflurane on microvascular function during cardiac surgery. We compared the effects of sevoflurane and desflurane on microvascular reactivity, as measured by the vascular occlusion tests (VOTs) during off-pump coronary artery bypass (OPCAB) surgery. Patients undergoing OPCAB were eligible for study inclusion. Patients were excluded if they were unsuitable for treatment with volatile agents or the VOT, had renal failure or uncontrolled diabetes, or were pregnant. The enrolled patients were randomized to receive sevoflurane or desflurane during surgery. Tissue oxygen saturation (StO 2 ) dynamics during the VOT were measured at baseline (pre-anesthesia), pre-anastomosis, post-anastomosis of vessel grafts, and at the end of surgery. Macrohemodynamic variables, arterial blood gas parameters, and in-hospital adverse events were also evaluated. A total of 64 patients (32 in each group) were analyzed. StO 2  dynamics did not differ between the groups. Compared to baseline, StO 2  and the rate of recovery following vascular occlusion decreased at the end of surgery in both groups (adjusted p-value, < 0.001), and no group difference was observed. Macrohemodynamic variables, blood gas analysis results, and the rate of postoperative in-hospital adverse events were similar between the groups. Microvascular reactivity, as measured by the VOT during OPCAB, showed no difference between the sevoflurane and desflurane groups. Also, there were no group differences in macrohemodynamics or the rate of postoperative adverse events. TRIAL REGISTRATION : Clinicaltrials.gov, identifier NCT03209193; registered on July 3, 2017.",2020,"Compared to baseline, StO 2  and the rate of recovery following vascular occlusion decreased at the end of surgery in both groups (adjusted p-value, < 0.001), and no group difference was observed.","['Patients undergoing OPCAB were eligible for study inclusion', 'Patients were excluded if they were unsuitable for treatment with volatile agents or the VOT, had renal failure or uncontrolled diabetes, or were pregnant', '64 patients (32 in each group) were analyzed']","['sevoflurane and desflurane', 'Desflurane', 'pump coronary artery bypass surgery', 'desflurane', 'anesthetics', 'sevoflurane or desflurane', 'propofol anesthesia', 'sevoflurane', 'pump coronary artery bypass (OPCAB) surgery']","['microvascular reactivity', 'Microvascular reactivity', 'Microvascular function', 'macrohemodynamics or the rate of postoperative adverse events', 'vascular occlusion tests (VOTs', 'Macrohemodynamic variables, arterial blood gas parameters, and in-hospital adverse events', 'rate of recovery following vascular occlusion', 'Tissue oxygen saturation (StO 2 ) dynamics', 'rate of postoperative in-hospital adverse events', 'microvascular function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",64.0,0.106919,"Compared to baseline, StO 2  and the rate of recovery following vascular occlusion decreased at the end of surgery in both groups (adjusted p-value, < 0.001), and no group difference was observed.","[{'ForeName': 'Youn Joung', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Sol Ji', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Karam', 'Initials': 'K', 'LastName': 'Nam', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Bae', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Seo Hee', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea.'}, {'ForeName': 'Yunseok', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. jeonyunseok@gmail.com.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00587-8']
2576,32915421,Continuous Lumbar Sympathetic Blockade Enhances the Effect of Lumbar Sympatholysis on Refractory Diabetic Neuropathy: A Randomized Controlled Trial.,"INTRODUCTION


There are a number of options for the symptomatic treatment of peripheral neuropathy, but the overall treatment outcomes remain unsatisfactory.
METHODS


A total of 60 patients with refractory diabetic neuropathy were randomly assigned to two groups. Patients in Group A were treated with computed tomography (CT)-guided sympathetic neurolysis with alcohol, and patients in Group B were treated with a combined therapy of CT-guided catheterization to achieve continuous lumbar block for 4 weeks followed by neurolysis with alcohol administered via the catheter. The outcomes of these two treatment strategies were then analyzed in terms of pain relief, blood flow in the lower limb microcirculation, plasma levels of inflammatory mediators, and complications.
RESULTS


The visual analog scale (VAS) pain scores of all patients after treatment decreased significantly at the different evaluation time points compared with pre-treatment values, with the intergroup analysis revealing that the VAS scores were lower in Group B patients than in Group A patients at all post-treatment time points. Skin temperature, capillary filling time, and blood oxygen saturation level were significantly improved in all patients at the 1- and 7-day post-treatment assessment compared to pre-treatment values, but patients in Group B showed a greater improvement. The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone. The results show that the procedures were associated with satisfactory safety outcomes and sustained analgesic effects, thereby providing clinical evidence supporting the use of this novel treatment for patients with painful diabetic neuropathy.",2020,"The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone.","['Refractory Diabetic Neuropathy', '60 patients with refractory diabetic neuropathy', 'patients with painful diabetic neuropathy']","['computed tomography (CT)-guided sympathetic neurolysis with alcohol', 'CT-guided catheterization to achieve continuous lumbar block for 4 weeks followed by neurolysis with alcohol administered via the catheter', 'Lumbar Sympatholysis']","['VAS scores', 'plasma levels of inflammatory mediators', 'Skin temperature, capillary filling time, and blood oxygen saturation level', 'pain relief, blood flow in the lower limb microcirculation, plasma levels of inflammatory mediators, and complications', 'satisfactory safety outcomes and sustained analgesic effects', 'visual analog scale (VAS) pain scores']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C2609163', 'cui_str': 'Sympatholysis'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0425716', 'cui_str': 'Capillary filling'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",60.0,0.0298423,"The plasma levels of inflammatory mediators were lower in all patients at the 7-day post-treatment assessment compared to pre-treatment values, with those of patients in Group B being statistically significantly lower than those of patients in Group A.
CONCLUSION


Combined treatment with continuous lumbar sympathetic block followed by neurolysis with alcohol provided more benefit in all assessed outcomes than sympathetic alcohol neurolysis alone.","[{'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Mingwei', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Xiangfei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Yansong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Center of Anesthesiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, 100029, China. majun7689@163.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00918-7']
2577,32915426,Is There An Advantage of Using Dingkun Pill () alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effects of Chinese medicine Dingkun Pill () alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS).
METHODS


This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment.
RESULTS


Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01). After treatment, TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P<0.05 or P<0.01); TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P<0.01), and no differences were observed between Diane-35 group and combined group (P>0.05).
CONCLUSIONS


Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638).",2020,"Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01).","['Totally 117 PCOS patients', 'PCOS patients', 'Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017', 'patients with polycystic ovary syndrome (PCOS']","['Diane-35 group took daily 7 g of oral Dingkun Pill', 'Dingkun Pill', 'Dingkun Pill () alone or in Combination with Diane-35', 'combination of Dingkun Pill and Diane-35', 'Chinese medicine Dingkun Pill () alone or in combination with Diane-35']","['insulin sensitivity, lowering TC and FFA', 'TC and FFA', 'QUICKI', 'TC, LDL-C and FFA', 'acne scores', 'glucose metabolism', 'Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores', 'LDL-C', 'TG', 'regular menstruation rate', 'total testosterone (TT) and menstruation regularity', 'TC']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0113572', 'cui_str': 'Diane-35'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}]",117.0,0.0661986,"Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Yan-Fang', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Shi-Yang', 'Initials': 'SY', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Ai-Jun', 'Initials': 'AJ', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China. saj_pumch@sina.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3097-4']
2578,32915500,A nomogram based on pretreatment clinical parameters for the prediction of inadequate biochemical response in primary biliary cholangitis.,"BACKGROUND


Ursodeoxycholic acid (UDCA) has been widely recommended as the first-line drug for primary biliary cholangitis (PBC) in the current guidelines. However, its therapeutic effects are poor in nearly one-third of patients. The early identification and intervention of these patients is crucial for delaying disease progression. Therefore, we explored risk factors for inadequate biochemical response and constructed a nomogram to predict the potential risk.
METHODS


We enrolled 356 patients and randomly divided them into training (70%) and validation groups (30%). We defined inadequate biochemical response as the study endpoint. Logistic analysis was used to identify the independent predictors of poor biochemical response. Based on these factors, a predictive nomogram was finally constructed. Then, discrimination and calibration were evaluated by internal validation. Additionally, the association between the model predictions and prognosis was further analyzed.
RESULTS


Female sex, and albumin and bilirubin concentrations were identified as risk factors, and a nomogram was built based on these factors. The areas under the ROC curves of the training and validation groups were 0.809 and 0.791, respectively. Moreover, calibration curves showed that predictions of the nomogram had good concordance with the actual outcomes. The correlation analysis demonstrated that PBC patients with a high probability of a suboptimal biochemical response were more likely to have adverse outcomes.
CONCLUSION


We constructed a nomogram, which can accurately predict the risk of inadequate biochemical response to UDCA, facilitating the early screening of high-risk patients with PBC who should be prioritized for additional therapy.",2020,"The correlation analysis demonstrated that PBC patients with a high probability of a suboptimal biochemical response were more likely to have adverse outcomes.
","['356 patients', 'high-risk patients with PBC who should be prioritized for additional therapy', 'primary biliary cholangitis']",['Ursodeoxycholic acid (UDCA'],['albumin and bilirubin concentrations'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0008312', 'cui_str': 'Primary biliary cholangitis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0427734', 'cui_str': 'Bilirubin concentration, test strip measurement'}]",356.0,0.0237834,"The correlation analysis demonstrated that PBC patients with a high probability of a suboptimal biochemical response were more likely to have adverse outcomes.
","[{'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Tian', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yansheng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Keshuai', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Shuoyi', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': ""Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}]",Journal of clinical laboratory analysis,['10.1002/jcla.23501']
2579,32915506,The development and testing of a nurse-led smartphone-based self-management programme for diabetes patients with poor glycaemic control.,"AIMS


To describe a systematic process for the development of a nurse-led smartphone-based self-management programme for type 2 diabetes patients with poor glycaemic control in Singapore.
METHODS


A three-step process involving the application of a theoretical framework, evidence from literature, content validity, and pilot tests were conducted for the content and technical development of the programme. Content experts and lay patients evaluated the appropriateness, relevance, and comprehensibility of the newly developed Care4Diabetes application. A pilot randomized controlled trial was conducted with 40 patients recruited in Singapore. Twenty patients each were randomly allocated to the control and intervention groups. The study outcomes were collected at baseline and at 3 months thereafter.
RESULTS


The nurse-led smartphone-based self-management programme was developed with integration of the Care4Diabetes application and the web-portal system. The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
CONCLUSION


The smartphone-based self-management intervention was deemed effective, yet full-scale randomized controlled trials are still ongoing and the results of these may provide strong evidence of the effectiveness of such an approach in improving patient care.
IMPACT


The uniqueness of this study lies in the integrated system used, which offers a clinical platform for diabetes nurses to provide personalized coaching and care to patients remotely, while monitoring patients' progress closely. By adopting such an approach, it would free up more time for nurses to cater to patients who are more critically in need of their direct attention.",2020,"The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
","['diabetes patients with poor glycaemic control', '40 patients recruited in Singapore', 'Twenty patients each', 'type 2 diabetes patients with poor glycaemic control in Singapore']","['smartphone-based self-management intervention', 'smartphone-based programme', 'nurse-led smartphone-based self-management programme']",[],"[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],40.0,0.035263,"The pilot results indicated that the effects of this smartphone-based programme on patient's health-related outcomes were comparable with those of the currently available nurse-led diabetes service.
","[{'ForeName': 'Wenru', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Michelle Tze Min', 'Initials': 'MTM', 'LastName': 'Cheng', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Foon Leng', 'Initials': 'FL', 'LastName': 'Leong', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Antoinette Wei Ling', 'Initials': 'AWL', 'LastName': 'Goh', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Suan Tee', 'Initials': 'ST', 'LastName': 'Lim', 'Affiliation': 'National University Hospital, National University Health System, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Journal of advanced nursing,['10.1111/jan.14519']
2580,32915512,A 3 year post-intervention follow-up on mortality in advanced heart failure (EVITA vitamin D supplementation trial).,"AIMS


Vitamin D supplementation is widely used in the clinical setting, but its effects on mortality and cardiovascular outcomes in patients with heart failure are unclear. This paper reports outcome data that were collected during follow-up of 3 years after closure of the EVITA trial (a 3 year randomized, placebo-controlled, intervention study with 4000 IU vitamin D daily in patients with advanced heart failure), to capture potential latency effects of vitamin D supplementation on clinical outcomes.
METHODS AND RESULTS


The prespecified primary endpoint was overall mortality. Secondary endpoints included hospitalization, mechanical circulatory support implantation, high urgent listing for heart transplantation, and heart transplantation. For group comparisons, we used Cox regression models with a time-dependent categorical covariate. The calculated net difference in circulating 25-hydroxyvitamin D between the vitamin D and placebo groups dropped from 60.9 nmol/L at the end of the active study period to 3.2 nmol/L at the end of the post-intervention period. During the entire 6 year period, 73 patients (36.5%) died in the placebo group and 76 (38.8%) in the vitamin D group. Out of these 149 patients, 36 and 39 died during the first 3 years, and 37 and 37 during the second 3 years, respectively. The hazard ratio (HR) for mortality in the vitamin D versus the placebo group was 1.06 [95% confidence interval (CI): 0.68-1.66] for the first 3 years and 1.07 (95% CI: 0.68-1.70) for the 3 year post-intervention follow-up. Compared with the placebo group, the HRs for hospitalization and for mechanical circulatory support implant were significantly higher in the vitamin D group during vitamin D supplementation (HR = 1.31, 95% CI: 1.01-1.68 and HR = 2.01, 95% CI: 1.08-3.76, respectively) but not after vitamin D discontinuation (HR = 1.10, 95% CI: 0.62-1.94 and HR = 0.99, 95% CI: 0.38-2.56, respectively). There was no significant time-dependent effect on the risk of high urgent listing for heart transplantation and heart transplantation.
CONCLUSIONS


No beneficial latency effects of vitamin D supplementation on overall mortality could be demonstrated. Instead, the disappearance of unfavourable findings in the vitamin D group (higher HRs for hospitalization and for mechanical circulatory support implant) after vitamin D discontinuation supports the assumption of adverse vitamin D effects on the cardiovascular system at doses of 4000 IU daily.",2020,"Compared with the placebo group, the HRs for hospitalization and for mechanical circulatory support implant were significantly higher in the vitamin D group during vitamin D supplementation (HR = 1.31, 95% CI: 1.01-1.68 and HR = 2.01, 95% CI: 1.08-3.76, respectively) but not after vitamin D discontinuation (HR = 1.10, 95% CI: 0.62-1.94 and HR = 0.99, 95% CI: 0.38-2.56, respectively).","['patients with heart failure', 'patients with advanced heart failure', '149 patients, 36 and 39 died during the first 3\xa0years, and 37 and 37 during the second 3\xa0years, respectively']","['vitamin D supplementation', 'vitamin D', 'vitamin D and placebo', 'placebo', 'Vitamin D supplementation']","['hospitalization, mechanical circulatory support implantation, high urgent listing for heart transplantation, and heart transplantation', 'HRs for hospitalization and for mechanical circulatory support implant', 'risk of high urgent listing for heart transplantation and heart transplantation', 'circulating 25-hydroxyvitamin D', 'hazard ratio (HR) for mortality', 'overall mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.499656,"Compared with the placebo group, the HRs for hospitalization and for mechanical circulatory support implant were significantly higher in the vitamin D group during vitamin D supplementation (HR = 1.31, 95% CI: 1.01-1.68 and HR = 2.01, 95% CI: 1.08-3.76, respectively) but not after vitamin D discontinuation (HR = 1.10, 95% CI: 0.62-1.94 and HR = 0.99, 95% CI: 0.38-2.56, respectively).","[{'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Zittermann', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Georgstraße 11, Bad Oeynhausen, D-32545, Germany.'}, {'ForeName': 'Jana B', 'Initials': 'JB', 'LastName': 'Ernst', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Georgstraße 11, Bad Oeynhausen, D-32545, Germany.'}, {'ForeName': 'Sylvana', 'Initials': 'S', 'LastName': 'Prokop', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Georgstraße 11, Bad Oeynhausen, D-32545, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Fuchs', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Georgstraße 11, Bad Oeynhausen, D-32545, Germany.'}, {'ForeName': 'Heiner K', 'Initials': 'HK', 'LastName': 'Berthold', 'Affiliation': 'Department of Internal Medicine and Geriatrics, Bethel Clinic (EvKB), Bielefeld, Germany.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Gouni-Berthold', 'Affiliation': 'Polyclinic for Endocrinology, Diabetes and Preventive Medicine (PEDP), University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Gummert', 'Affiliation': 'Clinic for Thoracic and Cardiovascular Surgery, Herz- und Diabeteszentrum NRW, Ruhr University Bochum, Georgstraße 11, Bad Oeynhausen, D-32545, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pilz', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}]",ESC heart failure,['10.1002/ehf2.12953']
2581,32905725,Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study.,"STUDY DESIGN


Historically controlled clinical trial.
OBJECTIVES


Patients presenting for correction of adolescent idiopathic scoliosis (AIS) by posterior spinal fusion may benefit from structured clinical pathways. We studied the effects of implementing a published clinical pathway for the perioperative care of patients with AIS that required intraoperative use of methadone at our institution.
METHODS


We performed a historically controlled clinical trial of patients undergoing posterior spinal fusion for AIS by comparing a retrospectively collected control group of 25 patients with a prospective experimental group of 14 patients receiving methadone, gabapentin, propofol, and remifentanil as part of a new clinical pathway.
RESULTS


Use of the pathway decreased average pain scores evaluated by the Numeric Rating Scale in the 24 hours following surgery (4.8 [4-6] to 3.4 [2-4],  P  = .03 [-2.6 to -0.2;  t  = -2.3]) and postoperative opioid consumption by 76% (41 [29-51] mg to 10 [4-17] mg,  P  < .001 [-45 to -15; Welch's  t  = 4.9]) during the same period. Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days,  P  = .001 [-2 to -1;  U  = 67,  Z  = -3.3]).
CONCLUSIONS


Multimodal analgesia and a clinical pathway add value in the perioperative care of patients undergoing posterior spinal fusion for AIS by improving analgesia and shortening hospitalization. The prospective arm of the trial was registered at clinicaltrials.gov under NCT02481570.",2020,"Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days,  P  = .001","['Patients presenting for correction of adolescent idiopathic scoliosis (AIS', 'patients with AIS that required intraoperative use of methadone at our institution', 'as part of a new clinical pathway', 'patients undergoing posterior spinal fusion for AIS by comparing a retrospectively collected control group of 25 patients with a prospective experimental group of 14 patients receiving', 'patients undergoing posterior spinal fusion for AIS by improving analgesia and shortening hospitalization', 'Adolescent Idiopathic Scoliosis Surgery']","['methadone, gabapentin, propofol, and remifentanil', 'Methadone']","['average pain scores', 'average hospital length of stay', 'Numeric Rating Scale', 'postoperative opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",25.0,0.0384119,"Improved analgesia and reduced reliance on opioids facilitated other postoperative elements of the clinical pathway and shortened the average hospital length of stay by 1 day (4 [3-6] days to 3 [3-5] days,  P  = .001","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Tams', 'Affiliation': '7060University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'F Cole', 'Initials': 'FC', 'LastName': 'Dooley', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Taranjit S', 'Initials': 'TS', 'LastName': 'Sangari', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Sandra N', 'Initials': 'SN', 'LastName': 'Gonzalez-Rodriguez', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Stoker', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Koenig', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Wishin', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Molinari', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Laurel C', 'Initials': 'LC', 'LastName': 'Blakemore', 'Affiliation': '12233University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Christoph N', 'Initials': 'CN', 'LastName': 'Seubert', 'Affiliation': '7060University of Utah Hospital, Salt Lake City, UT, USA.'}]",Global spine journal,['10.1177/2192568219878135']
2582,32905863,Behavioral and neurological effects of tDCS on speech motor recovery: A single-subject intervention study.,"This paper reports a feasibility study designed to evaluate the behavioral and neurological effects of using transcranial direct current stimulation (tDCS) in conjunction with speech motor learning treatment for individuals with acquired speech impairment subsequent to stroke. Most of the research using tDCS to enhance treatment outcomes in stroke recovery has focused on either limb motor control or aphasia treatment. Using a multiple-baseline multiple-probe crossover design, we compared both behavioral and brain connectivity-based outcomes following speech motor learning treatment with both Active tDCS and Sham tDCS. We observed that both treatment phases led to improvement in short-term maintenance, but that Active tDCS was associated with greater long-term maintenance improvement. Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment. This report supports the possibility that tDCS may enhance both behavioral and neurological outcomes and indicates the importance of additional work in this area, although replication is required to confirm the extent and consistency of tDCS benefits on speech motor learning treatment outcomes.",2020,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,['individuals with acquired speech impairment subsequent to stroke'],"['speech motor learning treatment with both Active tDCS and Sham tDCS', 'transcranial direct current stimulation (tDCS', 'tDCS', 'speech motor learning treatment']","['functional connectivity', 'speech motor recovery']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0164864,Active tDCS was also associated with an increase in functional connectivity in the left hemisphere and interhemispherically in an ROI-based network analysis examining correlations among areas associated with speech production and acquired speech impairment.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buchwald', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA. Electronic address: buchwald@nyu.edu.'}, {'ForeName': 'Nicolette', 'Initials': 'N', 'LastName': 'Khosa', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Rimikis', 'Affiliation': 'New York University, Department of Communicative Sciences and Disorders, 665 Broadway Suite 900, New York, NY 10012, USA.'}, {'ForeName': 'E Susan', 'Initials': 'ES', 'LastName': 'Duncan', 'Affiliation': 'Louisiana State University, Department of Communication Sciences and Disorders, 68 Hatcher Hall, Baton Rouge, LA 70803, USA.'}]",Brain and language,['10.1016/j.bandl.2020.104849']
2583,32905889,Role of inhaled corticosteroids in reducing exacerbations in bronchiectasis patients with blood eosinophilia pooled post-hoc analysis of 2 randomized clinical trials.,,2020,,['bronchiectasis patients with blood eosinophilia'],['inhaled corticosteroids'],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.174446,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. Electronic address: lsaderi@uniss.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Respiratory medicine,['10.1016/j.rmed.2020.106127']
2584,32905893,12-months follow-up of pulmonary tele-rehabilitation versus standard pulmonary rehabilitation: A multicentre randomised clinical trial in patients with severe COPD.,"Between March 2016 and October 2017, we randomised 134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group). We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme. The current study presents results from the 12-month follow-up with assessment of the 6MWD and analyses of hospitalisation and mortality. There were no significant differences between or within the groups in the 6MWD one year after completion of the programme.",2020,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"['134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient', 'patients with severe COPD']","['pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group', 'pulmonary tele-rehabilitation versus standard pulmonary rehabilitation']",['minutes walking distance (6MWD'],"[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",134.0,0.0811644,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute for Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Nina.Skavlan.Godtfredsen@regionh.dk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'The Research Unit for General Practice, Department of Public Health, University of Copenhagen, And Innovation and Research Centre for Multimorbidity and Chronic Conditions, Region Zealand, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical & Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Respiratory Medicine, Gentofte and Herlev University Hospital, Gentofte, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle Frost', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106129']
2585,32907352,Effects of Short-Term Inhalation of Patchouli Oil on Professional Quality of Life and Stress Levels in Emergency Nurses: A Randomized Controlled Trial.,"Objectives:  The aim of this study was to investigate the effects of patchouli ( Pogostemon cablin  Benth.) inhalation by emergency nurses on their stress, compassion satisfaction, compassion fatigue, burnout, blood pressure, and heart rate.  Design:  A randomized controlled trial.  Setting/location:  University hospital in Incheon.  Subjects:  This study was performed from May to August 2018 after all subjects provided written informed consent. Fifty eligible emergency nurses were recruited and randomly allocated to inhale 5% patchouli oil in sweet almond oil (patchouli group,  n  = 25) or pure sweet almond oil (control group,  n  = 25).  Interventions:  Nurses in the patchouli group first inhaled patchouli oil at about 10 pm (the end of an afternoon shift) and inhaled patchouli oil a second time at about 10 pm on next day (24-h interval). Nurses in the control group inhaled pure sweet almond oil following the same schedule.  Outcome measures:  Outcome measured included blood pressure, heart rate, levels of stress, compassion satisfaction, compassion fatigue, and burnout.  Results:  Although there were no significant differences in blood pressure, heart rate, compassion fatigue, and burnout, levels of stress were significantly lower (0.06 ± 0.48 vs. 1.19 ± 1.19,  p  < 0.001) and compassion satisfaction significantly higher (0.56 ± 2.50 vs. -2.84 ± 2.43,  p  < 0.001) in the patchouli than in the control group. In addition, relative to baseline, compassion fatigue was significantly lower in the patchouli group (26.72 ± 4.98 vs. 25.88 ± 4.63,  p  = 0.016).  Conclusions:  Inhalation of patchouli oil effectively reduced the levels of stress and increased compassion satisfaction in emergency nurses, suggesting that patchouli oil inhalation may improve the professional quality of life of emergency nurses. ClinicalTrials.gov ID: KCT0004615.",2020,"Although there were no significant differences in blood pressure, heart rate, compassion fatigue, and burnout, levels of stress were significantly lower (0.06 ± 0.48 vs. 1.19 ± 1.19,  ","['August 2018 after all subjects provided written informed consent', 'Emergency Nurses', 'Fifty eligible emergency nurses', 'emergency nurses', 'Subjects']","['patchouli group first inhaled patchouli oil at about 10 pm (the end of an afternoon shift) and inhaled patchouli oil', 'inhale 5% patchouli oil in sweet almond oil (patchouli group,  n \u2009=\u200925) or pure sweet almond oil (control group,  n \u2009=\u200925', 'patchouli oil', 'Patchouli Oil', 'patchouli ( Pogostemon cablin  Benth', 'control group inhaled pure sweet almond oil']","['compassion satisfaction', 'stress, compassion satisfaction, compassion fatigue, burnout, blood pressure, and heart rate', 'levels of stress and increased compassion satisfaction', 'compassion fatigue', 'blood pressure, heart rate, compassion fatigue, and burnout, levels of stress', 'blood pressure, heart rate, levels of stress, compassion satisfaction, compassion fatigue, and burnout', 'professional quality of life of emergency nurses', 'Professional Quality of Life and Stress Levels']","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C1002062', 'cui_str': 'Patchouli'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0304147', 'cui_str': 'Oil of patchouli'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0102271', 'cui_str': 'almond oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4042834', 'cui_str': 'Vicarious Traumatization'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",,0.139381,"Although there were no significant differences in blood pressure, heart rate, compassion fatigue, and burnout, levels of stress were significantly lower (0.06 ± 0.48 vs. 1.19 ± 1.19,  ","[{'ForeName': 'You Kyoung', 'Initials': 'YK', 'LastName': 'Shin', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'KT&G Central Research Institute, Daejeon, Republic of Korea.'}, {'ForeName': 'Purum', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Geun Hee', 'Initials': 'GH', 'LastName': 'Seol', 'Affiliation': 'Department of Basic Nursing Science, College of Nursing, Korea University, Seoul, Republic of Korea.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0206']
2586,32907366,Antithrombotic Effects of Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition.,"OBJECTIVE


PAR (protease-activated receptor)-4 antagonism has antiplatelet effects under conditions of high shear stress. We aimed to establish whether PAR4 antagonism had additive antithrombotic activity in the presence of factor Xa inhibition in an ex vivo model of acute arterial injury. Approach and Results: Fifteen healthy volunteers (29±6 years, 7 women) completed a phase zero double-blind randomized controlled crossover trial. Ex vivo platelet activation, platelet aggregation, and thrombus formation were measured following blood perfusion of low shear and high shear stress chambers. Upstream of the chambers, extracorporeal blood was admixed with (1) vehicle, (2) low-dose apixaban (20 ng/mL), (3) high-dose apixaban (80 ng/mL), (4) BMS-986141 (400 ng/mL), (5) BMS-968141 and low-dose apixaban, or (6) BMS-968141 and high-dose apixaban in 6 sequential studies performed in random order. Compared with vehicle, BMS-986141 demonstrated selective inhibition of PAR4-AP (agonist peptide)-stimulated platelet aggregation, platelet-monocyte aggregates, and P-selectin expression ( P ≤0.01 for all). Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle). BMS-968141 reduced total (≤44.4%) and platelet-rich (≤39.3%) thrombus area, whereas apixaban reduced total (≤42.9%) and fibrin-rich (≤31.6%) thrombus area. Combination of BMS-986141 with apixaban caused a further modest reduction in total thrombus area (9.6%-12.4%), especially under conditions of high shear stress ( P ≤0.027).
CONCLUSIONS


In the presence of factor Xa inhibition, PAR4 antagonism with BMS-986141 further reduces thrombus formation, especially under conditions of high shear stress. This suggests the potential for additive efficacy of combination PAR4 antagonism and factor Xa inhibition in the prevention of atherothrombotic events.",2020,Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle).,"['Fifteen healthy volunteers (29±6 years, 7 women']","['Combined PAR (Protease-Activated Receptor)-4 Antagonism and Factor Xa Inhibition', 'PAR4 antagonism', 'combination PAR4 antagonism and factor', 'BMS-968141 and low-dose apixaban, or (6) BMS-968141 and high-dose apixaban', 'BMS-986141 with apixaban']","['Ex vivo platelet activation, platelet aggregation, and thrombus formation', 'fibrin-rich', 'platelet-rich', 'selective inhibition of PAR4-AP (agonist peptide)-stimulated platelet aggregation, platelet-monocyte aggregates, and P-selectin expression', 'total thrombus area', 'Total thrombus area']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C1257901', 'cui_str': 'Proteinase-Activated Receptors'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",15.0,0.16133,Total thrombus area was reduced under both low shear and high shear stress conditions for all drug infusions ( P <0.0001 for all versus vehicle).,"[{'ForeName': 'Mohammed N', 'Initials': 'MN', 'LastName': 'Meah', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raftis', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Wilson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Perera', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Samira M', 'Initials': 'SM', 'LastName': 'Garonzik', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Murthy', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'J Gerry', 'Initials': 'JG', 'LastName': 'Everlof', 'Affiliation': 'Brisol-Myers Squibb, Lawrenceville Facility, Princeton, NJ (J.G.E., J.L.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Princeton Pike Facility, NJ (V.P., S.M.G., B.M., R.A.).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Luettgen', 'Affiliation': 'Brisol-Myers Squibb, Lawrenceville Facility, Princeton, NJ (J.G.E., J.L.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, United Kingdom (M.N.M., J.R., S.J.W., D.E.N.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314960']
2587,32907375,Aquatic high intensity interval training to improve aerobic capacity is feasible in adolescents with cerebral palsy: pilot randomised controlled trial.,"OBJECTIVE


To investigate feasibility of aquatic high intensity interval training for adolescents with cerebral palsy, who can ambulate independently but may choose a mobility aid in some circumstances.
DESIGN


Pilot randomised controlled trial.
METHOD


Following baseline assessments, participants were randomised to usual care or ten weeks of twice weekly aquatic high intensity interval training. Each class comprised 10 one-minute exercise intervals separated by one-minute rest. High intensity exercise was defined as the attainment of ⩾80% of peak heart rate measured by telemetry.
SETTING


Tertiary paediatric hospital.
MAIN MEASURES


Primary outcomes related to the feasibility of the protocol to progress to a definitive trial. Consumer feedback was obtained.
RESULTS


Of 119 potential participants, 46 appeared eligible and 17 consented, resulting in a recruitment fraction of 37% (95% CI 23-52). Twelve completed baseline assessments and were randomised (5 males; 14 years 7 months SD 2 years 0 months). In the intervention group, of the 1190 exercise stations (across all participants and sessions), heart rate data were available for 1180 stations and high intensity exercise was achieved during 1111 stations (93%, 95% CI 92-95). All randomised participants completed the study and reported that the intervention was fun and provided friendship opportunities. There were no major adverse events or exacerbation of pain.
CONCLUSIONS


Aquatic high intensity interval training in ambulant adolescents with cerebral palsy is feasible, while maintaining adherence and fidelity. Uncertainty remains on the efficacy of the intervention, highlighting the need for a large definitive trial.",2020,"There were no major adverse events or exacerbation of pain.
","['119 potential participants', 'Tertiary paediatric hospital', 'adolescents with cerebral palsy', 'ambulant adolescents with cerebral palsy']","['usual care or ten weeks of twice weekly aquatic high intensity interval training', 'aquatic high intensity interval training', 'Aquatic high intensity interval training']","['High intensity exercise', 'peak heart rate', 'major adverse events or exacerbation of pain', 'heart rate data']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0853946', 'cui_str': 'Pain worsened'}]",,0.228003,"There were no major adverse events or exacerbation of pain.
","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Depiazzi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Smith', 'Affiliation': ""Physiotherapy Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Noula', 'Initials': 'N', 'LastName': 'Gibson', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Langdon', 'Affiliation': ""Paediatric Rehabilitation Medicine Department, Perth Children's Hospital, Perth, Western Australia, Australia.""}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Science, Curtin University, Perth, WA, Australia.'}]",Clinical rehabilitation,['10.1177/0269215520956499']
2588,32907384,A mobile health application to support self-management in patients with chronic obstructive pulmonary disease: a randomised controlled trial.,"OBJECTIVE


To investigate the effects of a mobile health smartphone application to support self-management programmes on quality of life, self-management behaviour and exercise and smoking cessation behaviour in patients with chronic obstructive pulmonary disease (COPD).
DESIGN


A randomised controlled, single-blind trial, was carried out from November 2017 to February 2019, which included 78 participants admitted with COPD to the Affiliated Hospital of Zunyi Medical University in Guizhou. The study participants were randomised into intervention ( n  = 39) and control groups ( n  = 39).
METHODS


Participants in the intervention group undertook a mobile medical application-based programme in addition to routine care, and participants in the control group received only routine care. The outcome measures were health-related quality of life evaluated by the COPD Assessment-Test, self-management behaviour using the COPD Self-Management Scale and physical activity and smoking behaviour were measured using a self-designed questionnaire. Data collection was conducted at baseline, third month, sixth month and 12th months.
RESULTS


Thirty-five participants in the intervention group and 33 in the control group completed the study. Compared to the control group, participants in the intervention group showed statistically significant improvement in the COPD -Assessment -Test scores ( P  < 0.01) and in all domains of the COPD Self-Management Scale scores ( P  < 0.01) at 12th 12 months. Improvements in the COPD -Assessment -Test scores by 4.3 and 0.3 units, and in the total scores of the COPD Self-Management Scale total score by 23.01 and 2.28 units, respectively, were observed in the intervention and control groups, respectively over the 12-month study period. Meanwhile, the mobile health application programme also improved participants' exercise and smoking cessation behaviour.
CONCLUSIONS


The mobile health smartphone application to support self-management programmes was effective in improving health-related quality of life and self-management behaviour in patients with COPD.
TRIAL REGISTRATION


This study was registered in Chinese clinicaltrials.gov.",2020,"The mobile health smartphone application to support self-management programmes was effective in improving health-related quality of life and self-management behaviour in patients with COPD.
","['patients with chronic obstructive pulmonary disease (COPD', 'Participants in the intervention group undertook a', 'patients with COPD', 'November 2017 to February 2019, which included 78 participants admitted with COPD to the Affiliated Hospital of Zunyi Medical University in Guizhou', 'Thirty-five participants in the intervention group and 33 in the control group completed the study', 'patients with chronic obstructive pulmonary disease']","['mobile medical application-based programme in addition to routine care, and participants in the control group received only routine care', 'mobile health smartphone application to support self-management programmes']","['quality of life, self-management behaviour and exercise and smoking cessation behaviour', 'health-related quality of life evaluated by the COPD Assessment-Test, self-management behaviour using the COPD Self-Management Scale and physical activity and smoking behaviour', 'COPD Self-Management Scale scores', 'health-related quality of life and self-management behaviour', 'COPD -Assessment -Test scores', 'total scores of the COPD Self-Management Scale total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960692', 'cui_str': 'Chronic obstructive pulmonary disease assessment test score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",78.0,0.0606821,"The mobile health smartphone application to support self-management programmes was effective in improving health-related quality of life and self-management behaviour in patients with COPD.
","[{'ForeName': 'LianHong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'The Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.'}, {'ForeName': 'YunMei', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Nursing Department of ZunYi Medical University, ZunYi, China.'}, {'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'The Third Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Nursing Department of ZunYi Medical University, ZunYi, China.'}]",Clinical rehabilitation,['10.1177/0269215520946931']
2589,32907390,Correlation between retinal nerve fiber layer thickness and IOP variation in glaucoma suspects and patients with primary open-angle glaucoma.,"PURPOSE


To analyze the relationship between retinal nerve fiber layer thickness (RNFLT) and intraocular pressure (IOP) variation in glaucoma suspects (GS) and patients with primary open-angle glaucoma (POAG).
METHODS


Thirty-one GS and 34 POAG patients underwent ophthalmologic examination and 24-h IOP measurements. GS had IOPs ranging from 19 to 24 mmHg and/or suspicious appearance of the optic nerve. POAG patients had reproducible abnormal visual fields. We only included patients who presented with short-term IOP fluctuation >6 mm Hg (∆IOP). Only one eye per patient was included through a randomized process. Peripapillary RNFLT was assessed by spectral-domain optical coherence tomography. We correlated RNFLT with IOP parameters.
RESULTS


Mean IOP was similar between GS and POAG groups (15.6 ± 3.47 vs 15.6 ± 2.83 mmHg,  p  = 0.90) as was IOP peak at 6 AM (21.7 ± 3.85 vs 21.3 ± 3.80 mmHg,  p  = 0.68). Statistically significant negative correlations were found in POAG group between IOP at 6 AM and RNFLT in global ( r s  = -0.543;  p  < 0.001), inferior ( r s  = -0.540;  p  < 0.001), superior ( r s  = -0.405;  p  = 0.009), and nasal quadrants ( r s  = -0.561;  p  < 0.001). Negative correlations were also found between ∆IOP and RNFLT in global ( r s  = -0.591;  p  < 0.001), and all other sectors ( p  < 0.05). In GS IOP at 6 AM correlated only with inferior quadrant ( r s  = -0.307;  p  = 0.047).
CONCLUSION


IOP at 6 AM and ∆IOP had negative correlations with RNFLT quadrants in POAG. In GS this correlation occurred between IOP at 6 AM and inferior quadrant. These findings may indicate potential risk factors for glaucoma progression.",2020,"Statistically significant negative correlations were found in POAG group between IOP at 6 AM and RNFLT in global ( r s  = -0.543;  p  < 0.001), inferior ( r s  = -0.540;  p  < 0.001), superior ( r s  = ","['Thirty-one GS and 34 POAG patients underwent ophthalmologic examination and 24-h IOP measurements', 'glaucoma suspects (GS) and patients with primary open-angle glaucoma (POAG', 'glaucoma suspects and patients with primary open-angle glaucoma', 'patients who presented with short-term IOP fluctuation >6\u2009mm Hg (∆IOP']",['retinal nerve fiber layer thickness (RNFLT) and intraocular pressure (IOP) variation'],"['reproducible abnormal visual fields', '∆IOP and RNFLT in global ', 'IOP peak', 'Mean IOP']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0017614', 'cui_str': 'Glaucoma suspect'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2363846', 'cui_str': 'Intraocular pressure fluctuation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0632734,"Statistically significant negative correlations were found in POAG group between IOP at 6 AM and RNFLT in global ( r s  = -0.543;  p  < 0.001), inferior ( r s  = -0.540;  p  < 0.001), superior ( r s  = ","[{'ForeName': 'Sebastião', 'Initials': 'S', 'LastName': 'Cronemberger', 'Affiliation': 'Visual Sciences Laboratory, Department of Ophthalmology and Otorhinolaryngology of the Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Artur W', 'Initials': 'AW', 'LastName': 'Veloso', 'Affiliation': 'Visual Sciences Laboratory, Department of Ophthalmology and Otorhinolaryngology of the Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Veiga', 'Affiliation': 'Visual Sciences Laboratory, Department of Ophthalmology and Otorhinolaryngology of the Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Scarpelli', 'Affiliation': 'Visual Sciences Laboratory, Department of Ophthalmology and Otorhinolaryngology of the Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Yara C', 'Initials': 'YC', 'LastName': 'Sasso', 'Affiliation': 'Visual Sciences Laboratory, Department of Ophthalmology and Otorhinolaryngology of the Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Rafael V', 'Initials': 'RV', 'LastName': 'Merola', 'Affiliation': 'Visual Sciences Laboratory, Department of Ophthalmology and Otorhinolaryngology of the Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}]",European journal of ophthalmology,['10.1177/1120672120957584']
2590,32907456,Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years.,"Background and purpose - Better outcomes are reported for suture button (SB) compared with syndesmotic screws (SS) in patients treated for an acute ankle syndesmotic injury. One reason could be that screws are more rigid than an SB. A single tricortical 3.5 mm syndesmotic screw (TS) is the most dynamic screw option. Our hypothesis is that 1 SB and 1 TS provide similar results. Therefore, in randomized controlled trial, we compared the results between SB and TS for syndesmotic stabilization in patients with acute syndesmosis injury.Patients and methods - 113 patients with acute syndesmotic injury were randomized to SB (n = 55) or TS (n = 58). The American Orthopedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Score was the primary outcome measure. Secondary outcome measures included Manchester Oxford Foot Questionnaire (MOXFQ), Olerud-Molander Ankle score (OMA), visual analogue scale (VAS), EuroQol- 5D (EQ-5D), radiologic results, range of motion, complications, and reoperations (no implants were routinely removed). CT scans of both ankles were obtained after surgery, and after 1 and 2 years.Results - The 2-year follow-up rate was 84%. At 2 years, median AOFAS score was 97 in both groups (IQR SB 87-100, IQR TS 90-100, p = 0.7), median MOXFQ index was 5 in the SB group and 3 in the TS group (IQR 0-18 vs. 0-8, p = 0.2), and median OMA score was 90 in the SB group and 100 in the TS group (IQR 75-100 vs. 83-100, p = 0.2). The syndesmotic reduction was similar 2 years after surgery; 19/55 patients in the SB group and 13/58 in the TS group had a difference in anterior syndesmotic width ≥ 2 mm (p = 0.3). 0 patients in the SB group and 5 patients in the TS group had complete tibiofibular synostosis (p = 0.03). At 2 years, 10 TS were broken. Complications and reoperations were similar between the groups.Interpretation - We found no clinically relevant differences regarding outcome scores between the groups. TS is an inexpensive alternative to SB.",2020,Complications and reoperations were similar between the groups.,"['patients with acute syndesmosis injury', 'American Orthopedic Foot & Ankle Society (AOFAS', 'patients treated for an acute ankle syndesmotic injury', 'Patients and methods - 113 patients with acute syndesmotic injury']","['SB and TS', 'single tricortical 3.5\u2009mm syndesmotic screw (TS', 'suture button with single 3.5\u2009mm syndesmotic screw', 'suture button (SB', 'syndesmotic screws (SS', 'SB']","['median OMA score', 'median MOXFQ index', 'syndesmotic reduction', 'Complications and reoperations', 'Ankle-Hindfoot Score', 'anterior syndesmotic width', 'Manchester Oxford Foot Questionnaire (MOXFQ), Olerud-Molander Ankle score (OMA), visual analogue scale (VAS), EuroQol- 5D (EQ-5D), radiologic results, range of motion, complications, and reoperations', 'complete tibiofibular synostosis', 'median AOFAS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C3661498', 'cui_str': 'Syndesmotic Injuries'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0183717', 'cui_str': 'Suture button'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}]",113.0,0.197136,Complications and reoperations were similar between the groups.,"[{'ForeName': 'Benedikte Wendt', 'Initials': 'BW', 'LastName': 'Raede', 'Affiliation': 'Department of Orthopaedic Surgery, Baerum Hospital, Vestre Viken Hospital Trust.'}, {'ForeName': 'Ingrid Kvello', 'Initials': 'IK', 'LastName': 'Stake', 'Affiliation': 'Kalnes Hospital, Østfold Hospital Trust.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital.'}, {'ForeName': 'Silje Berild', 'Initials': 'SB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo.'}, {'ForeName': 'Mette Renate', 'Initials': 'MR', 'LastName': 'Andersen', 'Affiliation': 'Department of Orthopaedic Surgery, Baerum Hospital, Vestre Viken Hospital Trust.'}, {'ForeName': 'Wender', 'Initials': 'W', 'LastName': 'Figved', 'Affiliation': 'Department of Orthopaedic Surgery, Baerum Hospital, Vestre Viken Hospital Trust.'}]",Acta orthopaedica,['10.1080/17453674.2020.1818175']
2591,32907500,"Donafenib in progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer: results of a randomized, multicenter, phase II trial.","<b>Background:</b> An unmet need for more effective and affordable kinase inhibitors remains in patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) in China, where only sorafenib is approved for this indication. This study evaluated the 24-week objective response rate (ORR) to donafenib, a new domestic multikinase inhibitor, in the treatment of locally advanced or metastatic RAIR-DTC in patients with measurable lesions. Two dose regimens (300 mg twice daily vs. 200 mg twice daily) were used to determine its optimal dosage and safety for further phase III studies. <b>Methods: </b>This study was a randomized, open-label, multicenter, phase II trial. Thirty-five adult RAIR-DTC patients with at least one measurable targeted lesion by RECIST 1.1 were enrolled from 12 centers in China and randomized to receive either 200 mg (17 patients) or 300 mg (18 patients) donafenib orally twice daily for 24 weeks. The primary endpoint was ORR, and the secondary endpoints included progression-free survival (PFS), among others. Additionally, biochemical (serum thyroglobulin) and structural (total tumor diameter [TTD]) responses were assessed, change rates (ΔTTD) were calculated, and safety was evaluated. <b>Results:</b> The ORRs for the 200 mg and 300 mg arms were 12.5% and 13.33% (P=1.000), respectively. The 300 mg arm had a non-significant longer median PFS than the 200 mg arm (14.98 vs. 9.44 months) (P=0.351). There was a trend of more tumor shrinkage in the 300 mg arm compared to the 200 mg arm (average ΔTTD rate 0.52±0.71 vs. -0.04±1.55 mm/month p=0.1033). Most treatment-related adverse events (AEs) in both arms were grades 1-2. The most common grade 3 treatment-related AEs in both arms were palmar-plantar erythrodysesthesia (PPE) and hypertension; the sum occurrence rates of these two AEs in the 200 mg and 300 mg arms were 11.43% and 22.86%, respectively. <b>Conclusion: </b>Donafenib was generally well tolerated. Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC. The results warrant further studies on donafenib as a new feasible treatment option for RAIR-DTC patients.",2020,Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC.,"['locally advanced or metastatic RAIR-DTC in patients with measurable lesions', 'patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) in China', 'RAIR-DTC patients', 'progressive locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer', 'Thirty-five adult RAIR-DTC patients with at least one measurable targeted lesion by RECIST 1.1 were enrolled from 12 centers in China']",['Donafenib'],"['change rates (ΔTTD', 'biochemical (serum thyroglobulin) and structural (total tumor diameter [TTD]) responses', 'palmar-plantar erythrodysesthesia (PPE) and hypertension', 'ORR', 'tumor shrinkage', 'tolerated', '24-week objective response rate (ORR', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034553', 'cui_str': 'Radioactivity'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",[],"[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",35.0,0.0652874,Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yansong', 'Affiliation': 'Peking Union Medical College Hospital, 34732, Nuclear Medicine, Dongcheng-qu, Beijing, China; linyansong1968@163.com.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Henan Cancer Hospital, 377327, Zhengzhou, Henan, China; 13938276142@163.com.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': '5th Medical Center of Chinese PLA General Hospital, 26460, Fengtai-qu, Beijing, China; dingyong307h@163.com.'}, {'ForeName': 'Yizhuang', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Anhui Provincial Hospital, 117556, Hefei, Anhui, China; 1304676252@qq.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': 'Hunan Cancer Hospital, 117924, Nuclear Medicine, NO.582 Rd Xianjiahu, Yuelu District, Changsha, Changsha, Hu Nan, China, 410013; smsm3028@sina.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Tianjin Medical University General Hospital, 117865, Department of Nuclear Medicine, Tianjin, Tianjin, China; tanpost@163.com.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': 'Yunnan Cancer Hospital, 531840, Kunming, Yunnan, China; 13888158986@163.com.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Second Affiliated Hospital of Anhui Medical University, 533251, Hefei, China; chenzhendong@csco.org.cn.'}, {'ForeName': 'Rongfu', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, 26447, Beijing, Beijing, China; rongfu_wang@163.com.'}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': 'Fudan University Shanghai Cancer Center, 89667, Shanghai, Shanghai, China; jqh@163.com.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Sichuan University West China Hospital, 34753, Chengdu, Sichuan, China; huangrui1977@163.com.'}, {'ForeName': 'Linfa', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Zhejiang Cancer Hospital, 89680, Department of Nuclear Medicine, Zhejiang cancer hospital, Hangzhou, Zhejiang, China; pet-ct001@163.com.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2020.0235']
2592,32907521,Internet-Based Medication Management Services Improve Glycated Hemoglobin Levels in Patients with Type 2 Diabetes.,"Background:   Internet-based medication management services might help improve blood glucose control in patients with diabetes.   Introduction:   This study is a randomized controlled trial designed to explore the effect of telemedicine patient management on blood glucose control in Chinese patients with type 2 diabetes mellitus (T2DM).   Materials and Methods:   This study included patients with T2DM from the Department of Integrated Traditional Chinese and Western medicine of Tianjin Medical University Chu Hsien-I Memorial Hospital who consulted between January 2019 and December 2019; 120 patients were randomized to the control group (standard care) and the telemedicine group (in-hospital medication evaluation, drug reorganization, medical monitoring, and advice via telemedicine). The primary endpoint was targeted glycated hemoglobin (HbA 1c ) <7.0% from baseline to 6 months. The secondary endpoints were the changes in fasting blood glucose (FBG), changes in daily medication cost, changes in the number of drug types taken daily, and hypoglycemic events.   Results:   Rates of HbA 1c  <7% improved in the telemedicine groups ( p  = 0.019), whereas no changes were seen in the control group ( p  > 0.999). FBG levels decreased (telemedicine:  p  = 0.001; control:  p  = 0.007), but the differences were not statistically significant between groups. Daily medication costs decreased in the telemedicine group ( p  = 0.001), but the costs were similar between groups. The number of medication types decreased in the telemedicine group ( p  = 0.001). Hypoglycemic events decreased in the telemedicine group ( p  = 0.032), but not in the control group ( p  = 0.854).   Discussion:   Telemedicine could improve the rate of HbA 1c  <7%.   Conclusions:   An internet-based medication management model was an effective telemedicine method for patients with T2DM.",2020,"FBG levels decreased (telemedicine:  p  = 0.001; control:  p  = 0.007), but the differences were not statistically significant between groups.","['Chinese patients with type 2 diabetes mellitus (T2DM', 'Patients with Type 2 Diabetes', 'patients with diabetes', 'patients with T2DM from the Department of Integrated Traditional Chinese and Western medicine of Tianjin Medical University Chu Hsien-I Memorial Hospital who consulted between January 2019 and December 2019; 120 patients', 'patients with T2DM']","['telemedicine patient management', 'control group (standard care) and the telemedicine group (in-hospital medication evaluation, drug reorganization, medical monitoring, and advice via telemedicine', 'Internet-Based Medication Management Services']","['fasting blood glucose (FBG), changes in daily medication cost, changes in the number of drug types taken daily, and hypoglycemic events', 'Rates of HbA 1c', 'number of medication types', 'blood glucose control', 'Hypoglycemic events', 'glycated hemoglobin (HbA 1c ', 'Glycated Hemoglobin Levels', 'FBG levels', 'Daily medication costs']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0457591', 'cui_str': 'Type of drug'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",120.0,0.0214633,"FBG levels decreased (telemedicine:  p  = 0.001; control:  p  = 0.007), but the differences were not statistically significant between groups.","[{'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Department of Pharmacy, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Pharmacy, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}, {'ForeName': 'Yangkui', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Integrated Traditional Chinese and Western Medicine, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, NHC Key Laboratory of Hormones and Development, Tianjin Key Laboratory of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital, Tianjin, China.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0123']
2593,32907547,The effect of midwifery led counseling based on Gamble's approach on childbirth fear and self-efficacy in nulligravida women.,"BACKGROUND


Studies show that childbirth fear is a common problem among Iranian women. Therefore, most Iranian women prefer caesarean section for giving birth. This study investigated the effectiveness of a psychoeducational intervention by midwives (birth emotions - looking to improve expectant fear (BELIEF)) on decreasing childbirth fear and self-efficacy among first-time pregnant women who were afraid of giving birth.
METHODS


A number of 80 pregnant women participated in the study. They had received a score of ≥66 on the Wijma delivery expectancy/experience questionnaire. They were randomly assigned into two groups: intervention (n = 40) and control groups (n = 40). The intervention group received two face-to-face counseling sessions based on the BELEF protocol in the 24th and 34th weeks of pregnancy. Between these two sessions, it also received eight telephone-counseling sessions once a week. The control group only received the prenatal routine care. The outcome measures were childbirth fear, childbirth self-efficacy, and childbirth preference.
RESULTS


The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group. In addition, more women in the intervention group reported that they preferred to give normal vaginal birth than women in the control group.
CONCLUSION


The BELIEF protocol could be an effective approach in reducing childbirth fear and increasing childbirth self-efficacy among first-time pregnant women who are afraid of giving birth.
TRIAL REGISTRATION NUMBER


IRCT20101219005417N3, Date of Registration: 19-12-2018.",2020,The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group.,"['first-time pregnant women who were afraid of giving birth', 'pregnant women who are afraid of giving birth', '80 pregnant women participated in the study', 'nulligravida women', 'Iranian women']","['psychoeducational intervention by midwives (birth emotions - looking to improve expectant fear (BELIEF', 'two face-to-face counseling sessions based on the BELEF protocol', ""midwifery led counseling based on Gamble's approach"", 'prenatal routine care']","['childbirth fear, childbirth self-efficacy, and childbirth preference', 'reduction in childbirth fear', 'childbirth self-efficacy', 'childbirth fear and self-efficacy', 'normal vaginal birth', 'childbirth fear and increasing childbirth self-efficacy']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0232995', 'cui_str': 'Gravida 0'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0026082', 'cui_str': 'Midwifery'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",80.0,0.0435359,The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group.,"[{'ForeName': 'Laya', 'Initials': 'L', 'LastName': 'Firouzan', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Kharaghani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Zenoozian', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Moloodi', 'Affiliation': 'Substance Abuse and Dependence Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Jafari', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery. Zanjan University of Medical Sciences, Zanjan, Iran. elhamdjafari@gmail.com.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03230-1']
2594,32907591,Caffeine supplementation induces higher IL-6 and IL-10 plasma levels in response to a treadmill exercise test.,"BACKGROUND


An acute bout of exercise induces an inflammatory response characterized by increases in several cytokines. Caffeine ingestion could modify this inflammatory response. The aim of this study was to determine the effects of caffeine supplementation on plasma levels of cytokines, mainly IL-10 and IL-6, in response to exercise.
METHODS


In a randomized, crossover, double-blinded study design, thirteen healthy, well-trained recreational male athletes performed, on two different occasions, a treadmill exercise test (60 min at 70% VO 2 max) after ingesting 6 mg/kg body mass of caffeine or placebo. Blood samples were taken before exercising, immediately after finishing and 2 h after finishing the exercise. Plasma concentrations of IL-10, IL-6, IL-1β, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ, adrenaline, cortisol and cyclic adenosine monophosphate (cAMP) were determined. The capacity of whole blood cultures to produce cytokines in response to endotoxin (LPS) was also determined. Changes in blood variables were analyzed using a time (pre-exercise, post-exercise, recovery) x condition (caffeine, placebo) within-between subjects ANOVA with repeated measures.
RESULTS


Caffeine supplementation induced higher adrenaline levels in the supplemented participants after exercise (257.3 ± 53.2 vs. 134.0 ± 25.7 pg·mL - 1 , p = 0.03) and higher cortisol levels after recovery (46.4 ± 8.5 vs. 32.3 ± 5.6 pg·mL - 1 , p = 0.007), but it did not influence plasma cAMP levels (p = 0.327). The exercise test induced significant increases in IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels remaining high after recovery. Caffeine supplementation influenced only IL-6 (3.04 ± 0.40 vs. 3.89 ± 0.62 pg·mL - 1 , p = 0.003) and IL-10 (2.42 ± 0.54 vs. 3.47 ± 0.72 pg·mL - 1 , p = 0.01) levels, with higher concentrations after exercise in the supplemented condition. No effect of caffeine was observed on the in vitro stimulated cytokine production.
CONCLUSIONS


The results of the present study indicate a significant influence of caffeine supplementation increasing the response to exercise of two essential cytokines such as IL-6 and IL-10. However, caffeine did not influence changes in the plasma levels of other cytokines measured and the in vitro-stimulated cytokine production.",2020,"The exercise test induced significant increases in IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels remaining high after recovery.","['thirteen healthy, well-trained recreational male athletes']","['Caffeine supplementation', 'treadmill exercise test', 'caffeine', 'condition (caffeine, placebo', 'caffeine or placebo', 'Caffeine ingestion', 'caffeine supplementation']","['higher IL-6 and IL-10 plasma levels', 'plasma levels of cytokines, mainly IL-10 and IL-6', 'higher cortisol levels', 'adrenaline levels', 'blood variables', 'IL-6', 'IL-10', 'plasma cAMP levels', 'plasma levels', 'Plasma concentrations of IL-10, IL-6, IL-1β, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ, adrenaline, cortisol and cyclic adenosine monophosphate (cAMP', 'IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0201998', 'cui_str': 'Epinephrine measurement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.259623,"The exercise test induced significant increases in IL-10, IL-6, IL-1ra, IL-4, IL-8, IL-12 and IFN-γ plasma levels, with IL-6 and IL-10 levels remaining high after recovery.","[{'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Rodas', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Fundamental Biology and Health Sciences, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Martinez', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Nursing and Physiotherapy, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain. sonia.martinez@uib.es.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Aguilo', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Nursing and Physiotherapy, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Tauler', 'Affiliation': 'Research Group on Evidence, Lifestyles & Health, Department of Fundamental Biology and Health Sciences, Research Institute on Health Sciences (IUNICS). University of the Balearic Islands, Crta de Valldemossa, Km 7.5, E-07122, Palma, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00375-4']
2595,32907603,A qualitative assessment of factors influencing implementation and sustainability of evidence-based tobacco use treatment in Vietnam health centers.,"BACKGROUND


Effective strategies are needed to increase implementation and sustainability of evidence-based tobacco dependence treatment (TDT) in public health systems in low- and middle-income countries (LMICs). Our two-arm cluster randomized controlled trial (VQuit) found that a multicomponent implementation strategy was effective in increasing provider adherence to TDT guidelines in commune health center (CHCs) in Vietnam. In this paper, we present findings from a post-implementation qualitative assessment of factors influencing effective implementation and program sustainability.
METHODS


We conducted semi-structured qualitative interviews (n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites. Interviews were transcribed and translated into English. Two qualitative researchers used both deductive (guided by the Consolidated Framework for Implementation Research) and inductive approaches to analysis.
RESULTS


Facilitators of effective implementing of TDT included training and point-of-service tools (e.g., desktop chart with prompts for offering brief counseling) that increased knowledge and self-efficacy, patient demand for TDT, and a referral system, available in arm 2, which reduced the provider burden by shifting more intensive cessation counseling to a trained VHW. The primary challenges to sustainability were competing priorities that are driven by the Ministry of Health and may result in fewer resources for TDT compared with other health programs. However, providers and VHWs suggested several options for adapting the intervention and implementation strategies to address challenges and increasing engagement of local government committees and other sectors to sustain gains.
CONCLUSION


Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT. In addition, the results illustrate the dynamic interplay between barriers and facilitators for sustaining TDT at the policy and community/practice level, particularly in the context of centralized public health systems like Vietnam's. Sustaining gains in practice improvement and clinical outcomes will require strategies that include ongoing engagement with policymakers and other stakeholders at the national and local level, and planning for adaptations and subsequent resource allocations in order to meet the World Health Organization's goals promoting access to effective treatment for all tobacco users.
TRIAL REGISTRATION


NCT02564653 , registered September 2015.",2020,Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT.,"['commune health center (CHCs) in Vietnam', 'n = 52) with 13 CHC medical directors (i.e., physicians), 25 CHC health care providers (e.g., nurses), and 14 village health workers (VHWs) in 13 study sites', 'Vietnam health centers']",['semi-structured qualitative interviews'],"['knowledge and self-efficacy, patient demand for TDT']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0025081', 'cui_str': 'Medical Directors'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040332', 'cui_str': 'Tobacco dependence syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",52.0,0.0538565,Our findings offer insights into how a multicomponent implementation strategy influenced changes in the delivery of evidence-based TDT.,"[{'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'VanDevanter', 'Affiliation': 'Rory Myers College of Nursing, New York University, 433 First Avenue, New York, NY, 10010, USA.'}, {'ForeName': 'Milkie', 'Initials': 'M', 'LastName': 'Vu', 'Affiliation': 'Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population Health, NYU Langone Health, 180 Madison Ave., 17th floor, New York, NY, 10016, USA.'}, {'ForeName': 'Trang', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, 810 CT1A ĐN1, Ham Nghi Street, My Dinh 2 Ward, South Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Hoang', 'Initials': 'H', 'LastName': 'Van Minh', 'Affiliation': 'Hanoi University of Public Health, No 1A Duc Thang Street, Duc Thang Ward, North Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Nam Truong', 'Initials': 'NT', 'LastName': 'Nguyen', 'Affiliation': 'Institute of Social and Medical Studies, 810 CT1A ĐN1, Ham Nghi Street, My Dinh 2 Ward, South Tu Liem District, Hanoi, Vietnam.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': 'Department of Public Health Policy and Management, School of Global Public Health, New York University, 715 Broadway, New York, NY, 10012, USA. ds186@nyu.edu.'}]",Implementation science : IS,['10.1186/s13012-020-01035-6']
2596,32907614,The multi-biomarker disease activity test for assessing response to treatment strategies using methotrexate with or without prednisone in the CAMERA-II trial.,"OBJECTIVES


The CAMERA-II trial compared two tight-control, treat-to-target strategies, initiating methotrexate with prednisone (MTX+pred) or MTX with placebo (MTX+plac), in early RA-patients. The multi-biomarker disease activity (MBDA) blood test objectively measures RA disease activity with a score of 1-100. In CAMERA-II, response profiles of the MBDA score, its individual biomarkers, and DAS28 were assessed.
METHODS


We evaluated 92 patients from CAMERA-II of whom clinical data and serum for MBDA testing at baseline and ≥ 1 time-point from months 1, 2, 3, 4, 5, 6, 9, or 12 were available. Changes (∆) from baseline for DAS28 and MBDA score and comparisons of ∆DAS28 and ∆MBDA score over time within the MTX+pred versus the MTX+plac strategy were tested for significance with t tests. Changes in biomarker concentration from baseline to months 1-5 were tested with Wilcoxon signed rank test and tested for difference between treatment arms by Mann-Whitney U test.
RESULTS


MBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement. The 12 MBDA biomarkers could be grouped into 4 categories of response profiles, with significant responses for 4 biomarkers during the MTX+plac strategy and 9 biomarkers during the MTX+pred strategy.
CONCLUSIONS


MBDA tracked treatment response in CAMERA-II similarly to DAS28. More individual MBDA biomarkers tracked treatment response to MTX+pred than to MTX+plac. Four response profiles could be observed.
TRIAL REGISTRATION


CAMERA-II International Standard Randomised Controlled Trial Number: ISRCTN 70365169 . Registered on 29 March 2006, retrospectively registered.",2020,"MBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement.","['92 patients from CAMERA-II of whom clinical data and serum for MBDA testing at baseline and\u2009≥\u20091 time-point from months 1, 2, 3, 4, 5, 6, 9, or 12 were available']","['MTX+plac', 'methotrexate with or without prednisone', 'methotrexate with prednisone (MTX+pred) or MTX with placebo (MTX+plac']","['DAS28 and MBDA score and comparisons of ∆DAS28 and ∆MBDA score', 'biomarker concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",92.0,0.106989,"MBDA and DAS28 showed similar response profiles, with gradual improvement over the first 6 months in the MTX+plac group, and in the MTX+pred group faster improvement during month 1, followed by gradual improvement.","[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Jurgens', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Safy-Khan', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands. marysafy@hotmail.com.'}, {'ForeName': 'M J H', 'Initials': 'MJH', 'LastName': 'de Hair', 'Affiliation': 'Novartis Pharma BV, Amsterdam, the Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Bijlsma', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'P M J', 'Initials': 'PMJ', 'LastName': 'Welsing', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tekstra', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'F P J G', 'Initials': 'FPJG', 'LastName': 'Lafeber', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Sasso', 'Affiliation': 'Crescendo Bioscience, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'J W G', 'Initials': 'JWG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, University of Utrecht, G02.228, PO Box 85500, 3508, GA, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Arthritis research & therapy,['10.1186/s13075-020-02293-x']
2597,32907617,"Interleukin-6 receptor blockade or TNFα inhibition for reducing glycaemia in patients with RA and diabetes: post hoc analyses of three randomised, controlled trials.","BACKGROUND


Diabetes is common in patients with rheumatoid arthritis (RA). Interleukin (IL)-6 is implicated in both the pathogenesis of RA and in glucose homeostasis; this post hoc analysis investigated the effects of IL-6 receptor vs. tumour necrosis factor inhibition on glycosylated haemoglobin (HbA1c) in patients with RA with or without diabetes.
METHODS


Data were from two placebo-controlled phase III studies of subcutaneous sarilumab 150/200 mg q2w + methotrexate or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and a phase III monotherapy study of sarilumab 200 mg q2w vs. adalimumab 40 mg q2w. Patients with diabetes were identified by medical history or use of antidiabetic medication (patients with HbA1c ≥ 9% were excluded from all three studies). HbA1c was measured at baseline and weeks 12/24. Safety and efficacy were assessed in RA patients with or without diabetes.
RESULTS


Patients with diabetes (n = 184) were older, weighed more and exhibited higher RA disease activity than patients without diabetes (n = 1928). Regardless of diabetes status, in patients on background csDMARDs, least squares (LS) mean difference (95% CI) in change from baseline in HbA1c for sarilumab 150 mg/200 mg vs. placebo at week 24 was - 0.28 (- 0.40, - 0.16; nominal p <  0.0001) and - 0.42 (- 0.54, - 0.31; nominal p <  0.0001), respectively. Without csDMARDs, LS mean difference for sarilumab 200 mg vs. adalimumab 40 mg at week 24 was - 0.13 (- 0.22, - 0.04; nominal p = 0.0043). Greater reduction in HbA1c than placebo or adalimumab was observed at week 24 with sarilumab in patients with diabetes and/or baseline HbA1c ≥ 7%. There was no correlation between baseline/change from baseline in HbA1c and baseline/change from baseline in C-reactive protein, 28-joint Disease Activity Score, or haemoglobin, nor between HbA1c change from baseline and baseline glucocorticoid use. Medical history of diabetes or use of diabetes treatments had limited impact on safety and efficacy of sarilumab and was consistent with overall phase III findings in patients with RA.
CONCLUSIONS


In post hoc analyses, sarilumab was associated with a greater reduction in HbA1c than csDMARDs or adalimumab, independent of sarilumab anti-inflammatory effects. Prospective studies are required to further assess these preliminary findings.
TRIAL REGISTRATION


ClinTrials.gov NCT01061736: date of registration February 03, 2010; ClinTrials.gov NCT01709578: date of registration October 18, 2012; ClinTrials.gov NCT02332590: date of registration January 07, 2015.",2020,"In post hoc analyses, sarilumab was associated with a greater reduction in HbA1c than csDMARDs or adalimumab, independent of sarilumab anti-inflammatory effects.","['Patients with diabetes (n\u2009=\u2009184', 'patients with RA and diabetes', 'patients with RA with or without diabetes', 'RA patients with or without diabetes', 'patients with RA', 'patients with rheumatoid arthritis (RA', 'Patients with diabetes were identified by medical history or use of antidiabetic medication (patients with HbA1c ≥\u20099% were excluded from all three studies']","['Interleukin-6 receptor blockade or TNFα inhibition', 'subcutaneous sarilumab 150/200\u2009mg q2w\u2009+\u2009methotrexate or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs', 'sarilumab 200\u2009mg q2w vs. adalimumab 40\u2009mg q2w', 'placebo', 'adalimumab']","['Safety and efficacy', 'RA disease activity', 'C-reactive protein, 28-joint Disease Activity Score, or haemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.261879,"In post hoc analyses, sarilumab was associated with a greater reduction in HbA1c than csDMARDs or adalimumab, independent of sarilumab anti-inflammatory effects.","[{'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University Medical Center, 1000 Welch Road, Suite 203, Palo Alto, CA, 94304, USA. genovese@stanford.edu.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité University Medicine, Free University and Humboldt University of Berlin, Berlin, Germany.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hagino', 'Affiliation': 'Sanofi Genzyme, Bridgewater, NJ, USA.'}, {'ForeName': 'Karthinathan', 'Initials': 'K', 'LastName': 'Thangavelu', 'Affiliation': 'Sanofi Genzyme, Bridgewater, NJ, USA.'}, {'ForeName': 'Melitza', 'Initials': 'M', 'LastName': 'Iglesias-Rodriguez', 'Affiliation': 'Sanofi Genzyme, Bridgewater, NJ, USA.'}, {'ForeName': 'Gregory St', 'Initials': 'GS', 'LastName': 'John', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'González-Gay', 'Affiliation': 'University of Cantabria Hospital Universitario Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mandrup-Poulsen', 'Affiliation': 'University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Arthritis research & therapy,['10.1186/s13075-020-02229-5']
2598,32907766,The effect of mindfulness-based education given to individuals with substance-use disorder according to self-efficacy theory on self-efficacy perception.,"The aim of this research is to find the effect of mindfulness-based education given to ındividuals with substance-use disorder according to self-efficacy theory on self-efficacy perception. The research was planned as a test model with pretest-posttest control groups. Individuals who have been diagnosed with substance abuse in the substance abuse clinic of Turgut Ozal Medical Center, and at the Substance Abuse Treatment and Education Centre of Gaziantep 25 Aralık State Hospital formed the core of this study. The research was conducted between January 2018-May 2019. 112 patients, 56 in the treatment and 56 in the control group, participated in the study. Scientific research started after ethical approval. Mindfulness therapy was applied to experimental group patients. For the data collection, the Socio-Demographic Characteristics Questionnaire and Self-Efficacy-Sufficiency scale were used. t-Test for dependent variables to compare the mean scores of experimental and control groups and t-test for independent variables were used. It was seen that the average total Self-Efficacy-Sufficiency score of the patients in the treatment group was 76.50 ± 12.62 before the intervention and increased to 85.50 ± 14.95 after the intervention. There is a significant difference between the average scores. Even when the treatment and control groups are compared, a significant difference was still detected between the groups. There was no significant difference between the groups in two of the Self-Efficacy-Sufficiency steps after the intervention in the experimental group, but there were significant differences between the other two factors and total score averages.",2020,"There was no significant difference between the groups in two of the Self-Efficacy-Sufficiency steps after the intervention in the experimental group, but there were significant differences between the other two factors and total score averages.","['112 patients, 56 in the treatment and 56 in the control group, participated in the study', 'Individuals who have been diagnosed with substance abuse in the substance abuse clinic of Turgut Ozal Medical Center, and at the Substance Abuse Treatment and Education Centre of Gaziantep 25 Aralık State Hospital formed the core of this study', 'individuals with substance-use disorder']","['Mindfulness therapy', 'mindfulness-based education']","['average total Self-Efficacy-Sufficiency score', 'Socio-Demographic Characteristics Questionnaire and Self-Efficacy-Sufficiency scale', 'Self-Efficacy-Sufficiency steps']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020026', 'cui_str': 'State Hospitals'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",,0.0172427,"There was no significant difference between the groups in two of the Self-Efficacy-Sufficiency steps after the intervention in the experimental group, but there were significant differences between the other two factors and total score averages.","[{'ForeName': 'Berna', 'Initials': 'B', 'LastName': 'Bayır', 'Affiliation': 'KTO Karatay Üniversitesi, Sağlık Bilimleri Yüksekokulu, Konya, Turkey. Electronic address: berna.bayir23@hotmail.com.'}, {'ForeName': 'Rukuye', 'Initials': 'R', 'LastName': 'Aylaz', 'Affiliation': 'Malatya İnönü Üniversitesi, Hemşirelik Fakültesi, Malatya, Turkey. Electronic address: rukuye.aylaz@inonu.edu.tr.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2020.151354']
2599,32907777,Apalutamide and Overall Survival in Prostate Cancer.,"BACKGROUND


The phase 3 SPARTAN study evaluated apalutamide versus placebo in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo. At primary analysis, apalutamide improved median metastasis-free survival (MFS) by 2 yr and overall survival (OS) data were immature.
OBJECTIVE


We report the prespecified event-driven final analysis for OS.
DESIGN, SETTING, AND PARTICIPANTS


A total of 1207 patients with nmCRPC (diagnosed by conventional imaging) were randomised 2:1 to apalutamide (240mg/d) or placebo, plus on-going androgen deprivation therapy. After MFS was met and the study was unblinded, 76 (19%) patients still receiving placebo crossed over to apalutamide.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


OS and time to cytotoxic chemotherapy (TTChemo) were analysed by group-sequential testing with O'Brien-Fleming-type alpha spending function.
RESULTS AND LIMITATIONS


At median 52-mo follow-up, 428 deaths had occurred. The median treatment duration was 32.9 mo for apalutamide group and 11.5 mo for placebo group. Median OS was markedly longer with apalutamide versus placebo, reaching prespecified statistical significance (73.9 vs 59.9 mo, hazard ratio [HR]: 0.78 [95% confidence interval {CI}, 0.64-0.96]; p=0.016). Apalutamide also lengthened TTChemo versus placebo (HR: 0.63 [95% CI, 0.49-0.81]; p=0.0002). Discontinuation rates in apalutamide and placebo groups due to progressive disease were 43% and 74%, and due to adverse events 15% and 8.4%, respectively. Subsequent life-prolonging therapy was received by 371 (46%) patients in the apalutamide arm and by 338 (84%) patients in the placebo arm including 59 patients who received apalutamide after crossover. Safety was consistent with previous reports; when adverse events were adjusted for treatment exposure, rash had the greatest difference of incidence between the apalutamide and placebo groups.
CONCLUSIONS


Extension of OS with apalutamide compared with placebo conferred impactful benefit in patients with nmCRPC. There was a 22% reduction in the hazard of death in the apalutamide group despite 19% crossover (placebo to apalutamide) and higher rates of subsequent therapy in the placebo group.
PATIENT SUMMARY


With data presented herein, all primary and secondary study end points of SPARTAN were met; findings demonstrate the value of apalutamide as a treatment option for nonmetastatic castration-resistant prostate cancer.",2020,"Apalutamide also lengthened TTChemo versus placebo (HR: 0.63 [95% CI, 0.49-0.81]; p=0.0002).","['1207 patients with nmCRPC (diagnosed by conventional imaging', 'patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) and prostate-specific antigen doubling time of ≤10 mo', 'Prostate Cancer', 'patients with nmCRPC']","['apalutamide versus placebo', 'placebo', 'placebo, plus on-going androgen deprivation therapy']","['Safety', 'progressive disease', 'overall survival (OS) data', 'Apalutamide and Overall Survival', 'adverse events', 'hazard of death', 'median treatment duration', 'nonmetastatic castration-resistant prostate cancer', 'median metastasis-free survival (MFS', 'Median OS', 'OS and time to cytotoxic chemotherapy (TTChemo', 'Discontinuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",1207.0,0.655217,"Apalutamide also lengthened TTChemo versus placebo (HR: 0.63 [95% CI, 0.49-0.81]; p=0.0002).","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA, USA. Electronic address: MRSMITH@mgh.harvard.edu.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montréal, Québec, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Guy's, King's, and St. Thomas' Hospitals, and Sarah Cannon Research Institute, London, UK.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Georges Pompidou Hospital, University de Paris, Paris, France.'}, {'ForeName': 'Boris A', 'Initials': 'BA', 'LastName': 'Hadaschik', 'Affiliation': 'University of Duisburg-Essen, Essen, and Ruprecht-Karls University Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Julie N', 'Initials': 'JN', 'LastName': 'Graff', 'Affiliation': 'VA Portland Health Care System, Portland and Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Spanish National Cancer Research Centre (CNIO), Madrid and Biomedical Research Institute of Málaga (IBIMA), Spain.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mainwaring', 'Affiliation': 'Canossa Hospital, Oxley, Queensland, Australia.'}, {'ForeName': 'Ji Youl', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': ""St. Mary's Hospital of Catholic University, Seoul, South Korea.""}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Porre', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Andressa A', 'Initials': 'AA', 'LastName': 'Smith', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Sabine D', 'Initials': 'SD', 'LastName': 'Brookman-May', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA; Ludwig Maximilians University, Munich, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Janssen Research & Development, San Diego, CA, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Rooney', 'Affiliation': 'Janssen Research & Development, High Wycombe, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lopez-Gitlitz', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}]",European urology,['10.1016/j.eururo.2020.08.011']
2600,32907792,Report from an effort to prevent type 2 diabetes development in primary care.,"BACKGROUND


In a clinical trial 2009-2012, individuals with prediabetes were randomised to a lifestyle intervention (LI) focused on physical activity or care as usual (CAU), with the aim of reducing development of type 2 diabetes (T2DM). At study termination after three years, there was a significantly less of an increase in insulin resistance in LI compared with the CAU group. The aim of this extended follow-up was to investigate whether positive results concerning metabolic variables remained five years after study termination.
METHOD


All participants from the original study were contacted for a new follow-up with an oral glucose tolerance test, anthropometric measurements, blood pressure and blood samples. Questionnaires about lifestyle were completed.
RESULTS


A total of 69 of the original 123 participants were examined, and personal data for another five participants were collected from the medical charts (n = 74). The LI group showed a decrease in diastolic blood pressure (-4 mmHg, CI 95% 0.8-6.8, p = 0.014) and body weight (-3 kg, CI 95% 1.2-4.9, p = 0.002) since base-line. Weight loss in the LI group was significantly greater compared with weight loss in the CAU group (-3 kg, CI 0.1-5.9, p = 0.044). Insulin resistance markers and incident T2DM were similar among the groups.
CONCLUSION


Although without modifying the incidence of diabetes or the level of insulin resistance, a physical activity intervention may be used to induce sustainable weight change in subjects with prediabetes at the primary care level.",2020,"The LI group showed a decrease in diastolic blood pressure (-4 mmHg, CI 95% 0.8-6.8, p = 0.014) and body weight (-3 kg, CI 95% 1.2-4.9, p = 0.002) since base-line.","['subjects with prediabetes at the primary care level', 'A total of 69 of the original 123 participants were examined, and personal data for another five participants were collected from the medical charts (n = 74', '2009-2012, individuals with prediabetes']","['lifestyle intervention (LI) focused on physical activity or care as usual (CAU', 'CAU']","['oral glucose tolerance test, anthropometric measurements, blood pressure and blood samples', 'weight loss', 'body weight', 'Insulin resistance markers and incident T2DM', 'Weight loss', 'diastolic blood pressure', 'insulin resistance in LI']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",123.0,0.0656996,"The LI group showed a decrease in diastolic blood pressure (-4 mmHg, CI 95% 0.8-6.8, p = 0.014) and body weight (-3 kg, CI 95% 1.2-4.9, p = 0.002) since base-line.","[{'ForeName': 'Margareta I', 'Initials': 'MI', 'LastName': 'Hellgren', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Sweden; The Skaraborg Institute, Skövde, Sweden. Electronic address: margareta.leonardsson-hellgren@vgregion.se.'}, {'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Jansson', 'Affiliation': 'The Wallenberg Laboratory, Department of Molecular and Clinical Medicine, The Sahlgrenska Academy at the University of Gothenburg, Sweden. Electronic address: per-anders.jansson@medic.gu.se.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Lindblad', 'Affiliation': 'Department of Public Health and Community Medicine/Primary Health Care, The Sahlgrenska Academy at the University of Gothenburg, Sweden. Electronic address: ulf.lindblad@allmed.gu.se.'}]",Primary care diabetes,['10.1016/j.pcd.2020.08.019']
2601,32907801,Two-year cost effectiveness between two gradual tapering strategies in rheumatoid arthritis: cost-utility analysis of the TARA trial.,"OBJECTIVE


The aim of the current study was to evaluate the 2-year cost-utility ratio between tapering conventional synthetic disease-modifying antirheumatic drugs (csDMARD) first followed by the tumour necrosis factor (TNF)-inhibitor, or vice versa, in patients with rheumatoid arthritis (RA).
METHODS


Two-year data of the Tapering strategies in Rheumatoid Arthritis trial were used. Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months, were randomised into gradual tapering the csDMARD first followed by the TNF-inhibitor, or vice versa. Quality-adjusted life years (QALYs) were derived from the European Quality of life questionnaire with 5 dimensions. Healthcare and productivity costs were calculated with data from patient records and questionnaires. The incremental cost-effectiveness ratio and the incremental net monetary benefit were used to assess cost effectiveness between both tapering strategies.
RESULTS


94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first. QALYs (SD) were, respectively, 1.64 (0.22) and 1.65 (0.22). Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10). Therefore, total costs (SD) were €38 833 (€39 616) for tapering csDMARDs first, and €39 442 (€47 271) for tapering the TNF-inhibitor (p=0.88). For willingness-to-pay (WTP) levels <€83 800 tapering, the csDMARD first has the highest probability of being cost effective, while for WTP levels >€83 800 tapering the TNF-inhibitor first has the highest probability.
CONCLUSION


Our economic evaluation shows that costs are similar for both tapering strategies. Regardless of the WTP, tapering either the TNF-inhibitor or the csDMARD first is equally cost effective.
TRIAL REGISTRATION NUMBER


NTR2754.",2020,"Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10).","['rheumatoid arthritis', '94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first', 'patients with rheumatoid arthritis (RA', 'Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months']",['conventional synthetic disease-modifying antirheumatic drugs (csDMARD'],"['2-year cost-utility ratio', 'productivity loss', 'WTP levels', 'Quality-adjusted life years (QALYs', 'cost effectiveness', 'Medication costs', 'European Quality of life', 'incremental cost-effectiveness ratio', 'total costs (SD', 'Healthcare and productivity costs']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0243286,"Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10).","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tjallingius Martijn', 'Initials': 'TM', 'LastName': 'Kuijper', 'Affiliation': 'Rheumatology, Maasstad Hospital, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'N H A M', 'Initials': 'NHAM', 'LastName': 'Denissen', 'Affiliation': 'Rheumatology, Amphia Hospital, Breda, North Brabant, The Netherlands.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Gerards', 'Affiliation': 'Rheumatology, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'de Jager', 'Affiliation': 'Rheumatology, Albert Schweitzer Hospital, Dordrecht, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Wai-Kwan', 'Initials': 'WK', 'LastName': 'Lam-Tse', 'Affiliation': 'Rheumatology, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jolanda J', 'Initials': 'JJ', 'LastName': 'Luime', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217528']
2602,32906138,Effectiveness of iStent trabecular micro-bypass system combined with phacoemulsification vs. phacoemulsification alone in patients with glaucoma and cataract depending on the initial intraocular pressure.,"INTRODUCTION


To assess the effect of iStent trabecular micro-bypass implantation combined with phacoemulsification on intraocular pressure (IOP) and glaucoma medications, and to compare this to outcomes of phacoemulsification alone in patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP.
MATERIAL AND METHODS


80 subjects with cataract and POAG were randomized 1:1 to either iStent implantation and cataract surgery (iStent group) (n=44) or cataract surgery alone (control group) (n=36). Groups were divided according to initial IOP (after wash out period) into IOP < 26 mmHg, and IOP ≥26 mmHg. Patients were assessed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12 and 24. Outcome measures included best corrected visual acuity (BCVA), IOP and glaucoma medications.
RESULTS


Post-operatively at 24 months, mean IOP decreased from 20.93 ± 1.28 mmHg to 17.79 ± 2.50 in the IOP subgroup <26 mmHg and from 26.00 ± 0.00 to 19.86 ± 2.19 in the subgroup ≥26 mmHg in control group. In the iStent group <26 mmHg IOP decreased from 22.04 ± 1.64 mmHg to 15.57±2.13 and from 26.6 ±1.09 mmHg to 17.06±2.43 in the iStent group ≥ 26 mmHg.
CONCLUSION


In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone. In patients with baseline IOP <26mmHg surgery reduced IOP and medication use significantly decline through 2 years, with greater reductions achieved versus patients with baseline IOP ≥26 mmHg. The study was registered at ClinicalTrials.gov under the number NCT03807869.",2020,"In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone.","['80 subjects with cataract and POAG', 'patients with glaucoma and cataract depending on the initial intraocular pressure', 'patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP']","['phacoemulsification alone', 'iStent trabecular micro-bypass system combined with phacoemulsification vs. phacoemulsification alone', 'iStent implantation and cataract surgery (iStent group) (n=44) or cataract surgery alone (control group', 'iStent trabecular micro-bypass implantation combined with phacoemulsification', 'cataract surgery reduced IOP']","['intraocular pressure (IOP) and glaucoma medications', 'corrected visual acuity (BCVA), IOP and glaucoma medications', 'mean IOP']","[{'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",80.0,0.0636821,"In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone.","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Kozera', 'Affiliation': ''}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Konopińska', 'Affiliation': ''}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Mariak', 'Affiliation': ''}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Rękas', 'Affiliation': ''}]",Ophthalmic research,['10.1159/000511456']
2603,32906163,[Reduction of Visitor- and Staff-Associated Risk of Infection by Complex Intervention in the Department of Feto-Maternal Medicine].,"AIM


Clinical trial registration of this trial: is to demonstrate in a department of feto-maternal medicine: (a) that a complex intervention improves hand hygiene of visitors, siblings and staff; and (b) that automated voice prompts at disinfectant dispensers improve rate of hand disinfection.
STUDY DESIGN


(a) Pre-/post-test follow-up design with control (1-12/2016), intervention (1-12/2017), follow-up-period (1/2018-12/2019); and (b) RCT in quasi crossover design. Primary endpoints: (a) disinfectant consumption (DC) per patient-day, and (b) DC at disinfectant dispenser per passer-by.
RESULTS


A multimodal strategy within the intervention period showed a relevant positive effect on hand hygiene compliance (in IP: 26.2% more DC; p=0.088). Voice prompts increased DC by 28.6% (p=0.025). The odds ratio for high positive fingertip testing plates of visiting children (siblings) between control and intervention period was 0.35 (95% CI [0.1074-0.9708] p=0.039).
CONCLUSION


Complex intervention and electronic voice prompts on disinfectant dispensers improve hand hygiene behaviour in perinatology. Installation of disinfectant dispensers in a child-friendly position and adequate information material appeal to children. The data represent an important contribution to improve hand hygiene of visitors, siblings and staff in hospitals in a pandemic situation.",2020,Voice prompts increased DC by 28.6% (p=0.025).,['perinatology'],['complex intervention'],"['Visitor- and Staff', 'hand hygiene compliance', 'disinfectant consumption (DC) per patient-day, and (b) DC at disinfectant dispenser per passer-by', 'rate of hand disinfection']","[{'cui': 'C0031063', 'cui_str': 'Perinatology'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0012682', 'cui_str': 'Disinfectant'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0999347', 'cui_str': 'Passer'}, {'cui': 'C0018570', 'cui_str': 'Disinfection, Hand'}]",,0.094279,Voice prompts increased DC by 28.6% (p=0.025).,"[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Seliger', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Krol', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Worlitzsch', 'Affiliation': 'Universitätsklinikum/Stabsstelle Krankenhaushygiene, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institut für Medizinische Epidemiologie, Biometrie und Informatik, Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Medizincontrolling/Sachgebiet Klinische Infektologie, Universitätsklinikum Halle (Saale), Martin-Luther-Universität Halle-Wittenberg, Halle.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tchirikov', 'Affiliation': 'Universitätsklinik und Poliklinik für Geburtshilfe und Pränatalmedizin, Martin-Luther-Universität Halle-Wittenberg, Halle.'}]",Zeitschrift fur Geburtshilfe und Neonatologie,['10.1055/a-1226-7257']
2604,32906223,A quality improvement project to improve the identification and management of delirium.,"INTRODUCTION


Efforts to reduce delirium burden through screening, identification, and prevention is considered one of the major public health priorities of the last decade. In 2017, an audit of delirium screening in our unit revealed suboptimum assessment of our patients, with compliance with the Confusion Assessment Method for the ICU (CAM-ICU) assessments highly variable and ad hoc, and sometimes not at all. A separate sedation audit also revealed that our sedation practices did not align with current critical care guidelines emphasizing light sedation strategies.
OBJECTIVES/AIMS


The aim of this project was to develop resources to educate the unit on delirium, improve the management of sedation with a sedation algorithm, formalize the elements of delirium prevention and care into a delirium pathway, and improve the compliance with delirium screening.
METHODS


We developed a delirium clinical pathway and sedation algorithm, a delirium resource book, and an online educational module on the district health board (DHB) intranet. We provided extensive teaching of all these resources over delirium month. We used pre- and post-auditing of sedation practices and delirium screening compliance to inform the success of this project.
RESULTS


Of the 140 members of staff, 85% (n = 120) received delirium education. In 2018/2019, 84% of 145 patient charts reached the unit standard of four to six hourly CAM-ICU assessments compared with 45% in 2017. The sedation audit revealed a slight improvement in the trend towards lighter sedation, with Richmond Agitation Sedation Scoring (RASS) scores reflecting light sedation, increasing from a mean of 31% in 2017 to 41% in 2019 from 41 patient charts.
CONCLUSIONS


This project provides a useful framework to enable future quality improvement work around delirium and sedation management. The clinical pathway and sedation algorithm have been a useful tool to introduce to the unit as a way of formalizing the elements of delirium care and assessment.",2020,"The sedation audit revealed a slight improvement in the trend towards lighter sedation, with Richmond Agitation Sedation Scoring (RASS) scores reflecting light sedation, increasing from a mean of 31% in 2017 to 41% in 2019 from 41 patient charts.
","['Of the 140 members of staff, 85% (n = 120) received delirium education']",[],"['lighter sedation, with Richmond Agitation Sedation Scoring (RASS) scores reflecting light sedation']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",,0.0381659,"The sedation audit revealed a slight improvement in the trend towards lighter sedation, with Richmond Agitation Sedation Scoring (RASS) scores reflecting light sedation, increasing from a mean of 31% in 2017 to 41% in 2019 from 41 patient charts.
","[{'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Sutton-Smith', 'Affiliation': 'Intensive Care Unit, Wellington Regional Hospital (Capital & Coast DHB), Wellington Regional Hospital, Wellington, New Zealand.'}]",Nursing in critical care,['10.1111/nicc.12549']
2605,32906232,"Étude de phase III, contrôlée, randomisée, de supériorité de galcanézumab versus placebo, chez les patients atteints de migraine difficile à traiter : résultats de l’étude CONQUER.",,2020,,[],[],[],[],[],[],,0.0169384,,"[{'ForeName': 'Wim M', 'Initials': 'WM', 'LastName': 'Mulleners', 'Affiliation': 'Service de neurologie, Canisius Wilhelmina Hospital, Nijmegen, Pays-Bas.'}, {'ForeName': 'Byungkun', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Service de neurologie, Eulji Hospital, Séoul, République de Corée.'}, {'ForeName': 'Miguel Ja', 'Initials': 'MJ', 'LastName': 'Láinez', 'Affiliation': 'Hospital clínico universitario, Universidad Católica de Valencia, València, Espagne.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lanteri-Minet', 'Affiliation': ""Service de traitement de la douleur,\xa0CHU de Nice et FHU InovPain, Université Côte d'Azur, Nice. Electronic address: carrie.foster@rxcomms.com.""}, {'ForeName': 'Sheena K', 'Initials': 'SK', 'LastName': 'Aurora', 'Affiliation': 'Medical department, Eli Lilly and Company, Indianapolis, États-Unis.'}, {'ForeName': 'Russell M', 'Initials': 'RM', 'LastName': 'Nichols', 'Affiliation': 'Medical department, Eli Lilly and Company, Indianapolis, États-Unis.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Statistics,\xa0Eli Lilly and Company, Indianapolis, États-Unis.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tockhorn-Heidenreich', 'Affiliation': 'Gporwe,\xa0Eli Lilly and Company, Windlesham, Royaume Uni.'}, {'ForeName': 'Holland C', 'Initials': 'HC', 'LastName': 'Detke', 'Affiliation': 'Medical department, Eli Lilly and Company, Indianapolis, États-Unis.'}]",Revue neurologique,['10.1016/j.neurol.2020.01.286']
2606,32862476,Platelet-poor plasma gel vs platelet-rich plasma for infraorbital rejuvenation: A clinical and dermoscopic comparative study.,"Infraorbital dark circles and tear trough deformity are considered common aesthetic problems. Numerous therapeutic modalities have been suggested with variable outcomes. The aim of this study was to compare the efficacy of platelet-poor plasma (PPP) gel vs platelet-rich plasma (PRP) in infraorbital rejuvenation. A total of 68 females presented with dark circles and/or tear trough deformity were recruited and treated by PPP gel injection in the right infraorbital region (Group A) and PRP injection in the left infraorbital region (Group B). They received three treatment sessions at 2-week interval, and followed up monthly for 3 months. They were evaluated clinically and dermoscopically before treatment and at the end of follow-up period. Both groups showed significant clinical improvements proved by significant reduction of degree of hyperpigmentation and tear trough rating scale. Obviously, more significant clinical and dermoscopic improvements were observed in Group A than Group B. Therefore, it could be concluded that both PPP gel and PRP were clinically effective procedures for aesthetic improvement of infraorbital region. Moreover, PPP gel seems to be significantly more effective than PRP as a therapeutic modality.",2020,Both groups showed significant clinical improvements proved by significant reduction of degree of hyperpigmentation and tear trough rating scale.,"['68 females presented with dark circles and/or tear trough deformity', 'infraorbital rejuvenation']","['Platelet-poor plasma gel vs platelet-rich plasma', 'PPP gel', 'platelet-poor plasma (PPP) gel vs platelet-rich plasma (PRP', 'PPP gel and PRP', 'PPP gel injection in the right infraorbital region (Group A) and PRP injection']",['degree of hyperpigmentation and tear trough rating scale'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}]","[{'cui': 'C0370219', 'cui_str': 'Platelet poor plasma'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",68.0,0.0166229,Both groups showed significant clinical improvements proved by significant reduction of degree of hyperpigmentation and tear trough rating scale.,"[{'ForeName': 'Yomna Mazid El-Hamd', 'Initials': 'YME', 'LastName': 'Neinaa', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Abeer Abd El-Hakam', 'Initials': 'AAE', 'LastName': 'Hodeib', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mariam Maher', 'Initials': 'MM', 'LastName': 'Morquos', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Lamia Hamouda', 'Initials': 'LH', 'LastName': 'Elgarhy', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Dermatologic therapy,['10.1111/dth.14255']
2607,32867803,Effect of withholding early parenteral nutrition in PICU on ketogenesis as potential mediator of its outcome benefit.,"BACKGROUND


In critically ill children, omitting early use of parenteral nutrition (late-PN versus early-PN) reduced infections, accelerated weaning from mechanical ventilation, and shortened PICU stay. We hypothesized that fasting-induced ketogenesis mediates these benefits.
METHODS


In a secondary analysis of the PEPaNIC RCT (N = 1440), the impact of late-PN versus early-PN on plasma 3-hydroxybutyrate (3HB), and on blood glucose, plasma insulin, and glucagon as key ketogenesis regulators, was determined for 96 matched patients staying ≥ 5 days in PICU, and the day of maximal 3HB-effect, if any, was identified. Subsequently, in the total study population, plasma 3HB and late-PN-affected ketogenesis regulators were measured on that average day of maximal 3HB effect. Multivariable Cox proportional hazard and logistic regression analyses were performed adjusting for randomization and baseline risk factors. Whether any potential mediator role for 3HB was direct or indirect was assessed by further adjusting for ketogenesis regulators.
RESULTS


In the matched cohort (n = 96), late-PN versus early-PN increased plasma 3HB throughout PICU days 1-5 (P < 0.0001), maximally on PICU day 2. Also, blood glucose (P < 0.001) and plasma insulin (P < 0.0001), but not glucagon, were affected. In the total cohort (n = 1142 with available plasma), late-PN increased plasma 3HB on PICU day 2 (day 1 for shorter stayers) from (median [IQR]) 0.04 [0.04-0.04] mmol/L to 0.75 [0.04-2.03] mmol/L (P < 0.0001). The 3HB effect of late-PN statistically explained its impact on weaning from mechanical ventilation (P = 0.0002) and on time to live PICU discharge (P = 0.004). Further adjustment for regulators of ketogenesis did not alter these findings.
CONCLUSION


Withholding early-PN in critically ill children significantly increased plasma 3HB, a direct effect that statistically mediated an important part of its outcome benefit.",2020,"Also, blood glucose (P < 0.001) and plasma insulin (P < 0.0001), but not glucagon, were affected.",[],[],"['plasma 3-hydroxybutyrate (3HB), and on blood glucose, plasma insulin, and glucagon as key ketogenesis regulators', 'blood glucose', 'time to live PICU discharge', 'plasma insulin', 'plasma 3HB and late-PN-affected ketogenesis regulators', 'plasma 3HB']",[],[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",96.0,0.15812,"Also, blood glucose (P < 0.001) and plasma insulin (P < 0.0001), but not glucagon, were affected.","[{'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'De Bruyn', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Gunst', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Chloë', 'Initials': 'C', 'LastName': 'Goossens', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vander Perre', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Gonzalo G', 'Initials': 'GG', 'LastName': 'Guerra', 'Affiliation': ""Department of Paediatrics, Intensive Care Unit, University of Alberta, Stollery Children's Hospital, Edmonton, AB, Canada.""}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Verbruggen', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Joosten', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre-Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Langouche', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, KU Leuven, 3000, Leuven, Belgium. greet.vandenberghe@kuleuven.be.'}]","Critical care (London, England)",['10.1186/s13054-020-03256-z']
2608,32907635,Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


The OVID study will demonstrate whether prophylactic-dose enoxaparin improves survival and reduces hospitalizations in symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.
TRIAL DESIGN


The OVID study is conducted as a multicentre open-label superiority randomised controlled trial.
PARTICIPANTS


Inclusion Criteria 1. Signed patient informed consent after being fully informed about the study's background. 2. Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment. 3. Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature >37.5° C. 4. Ability of the patient to travel to the study centre by private transportation, performed either by an accompanying person from the same household or by the patient themselves 5. Ability to comply with standard hygiene requirements at the time of in-hospital visit, including a face mask and hand disinfectant. 6. Ability to walk from car to study centre or reach it by wheelchair transport with the help of an accompanying person from the same household also complying with standard hygiene requirements. 7. Ability to self-administer prefilled enoxaparin injections after instructions received at the study centre or availability of a person living with the patient to administer enoxaparin. Exclusion Criteria 1. Any acute or chronic condition posing an indication for anticoagulant treatment, e.g. atrial fibrillation, prior venous thromboembolism (VTE), acute confirmed symptomatic VTE, acute coronary syndrome. 2. Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history, comorbidity or predisposing strong risk factors for thrombosis:  a. Any of the following events occurring in the prior 30 days: fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke,  b. previous VTE,  c. histologically confirmed malignancy, which was diagnosed or treated (surgery, chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or inoperable. 3. Any clinically relevant bleeding (defined as bleeding requiring hospitalization, transfusion, surgical intervention, invasive procedures, occurring in a critical anatomical site, or causing disability) within 30 days prior to randomization or sign of acute bleeding. 4. Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute intracranial haemorrhage. 5. Haemoglobin <8 g/dL and platelet count <50 x 10 9  cells/L confirmed by recent laboratory test (<90 days). 6. Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy. 7. Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days). 8. Contraindications to enoxaparin therapy, including prior heparin-induced thrombocytopenia and known hypersensitivity. 9. Current use of dual antiplatelet therapy. 10. Participation in other interventional studies over the past 30 days. 11. Non-compliance or inability to adhere to treatment or lack of a family environment or support system for home treatment. 12. Cognitive impairment and/or inability to understand information provided in the study information. Patient enrolment will take place at seven Swiss centres, including five university hospitals and two large cantonal hospitals.
INTERVENTION AND COMPARATOR


Patients randomized to the intervention group will receive subcutaneous enoxaparin at the recommended dose of 4,000 IU anti-Xa activity (40 mg/0.4 ml) once daily for 14 days. Patients randomized to the comparator group will receive no anticoagulation.
MAIN OUTCOMES


Primary outcome: a composite of any hospitalization or all-cause death occurring within 30 days of randomization.
SECONDARY OUTCOMES


(i) a composite of cardiovascular events, including deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke within 14 days, 30 days, and 90 days of randomization; (ii) each component of the primary efficacy outcome, within 14 days, 30 days, and 90 days of randomization; (iii) net clinical benefit (accounting for the primary efficacy outcome, composite cardiovascular events, and major bleeding), within 14 days, 30 days, and 90 days of enrolment; (iv) primary efficacy outcome, within 14 days, and 90 days of enrolment; (v) disseminated intravascular coagulation (ISTH criteria, in-hospital diagnosis) within 14 days, 30 days, and 90 days of enrolment.
RANDOMISATION


Patients will undergo block stratified randomization (by age: 50-70 vs. >70 years; and by study centre) with a randomization ratio of 1:1 with block sizes varying between 4 and 8. Randomization will be performed after the signature of the informed consent for participation and the verification of the eligibility criteria using the electronic data capture software (REDCAP, Vanderbilt University, v9.1.24).
BLINDING (MASKING)


In this open-label study, no blinding procedures will be used.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The sample size calculation is based on the parameters α = 0.05 (2-sided), power: 1-β = 0.8, event rate in experimental group, pexp = 0.09 and event rate in control group, pcon = 0.15. The resulting total sample size is 920. To account for potential dropouts, the total sample size was fixed to 1000 with 500 patients in the intervention group and 500 in the control group.
TRIAL STATUS


Protocol version 1.0, 14 April 2020. Protocol version 3.0, 18 May 2020 Recruiting start date: June 2020. Last Patient Last Visit: March 2021.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04400799 First Posted: May 26, 2020 Last Update Posted: July 16, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature","['Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days and eligible for ambulatory treatment', 'symptomatic ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation', 'ambulatory patients with coronavirus disease-2019 (the OVID study', 'Patients will undergo block stratified randomization (by age: 50-70 vs. >70 years; and by study centre) with a randomization ratio of 1:1 with block sizes varying between 4 and 8', 'Subjects with any known coagulopathy or bleeding diathesis, including known significant liver disease associated with coagulopathy', 'Protocol version 1.0, 14 April 2020', '500 patients in the intervention group and 500 in the control group', 'Patient enrolment will take place at seven Swiss centres, including five university hospitals and two large cantonal hospitals']","['enoxaparin injections', 'subcutaneous enoxaparin', 'Enoxaparin', 'enoxaparin', '4,000 IU anti-Xa activity', 'prophylactic-dose enoxaparin', 'comparator group will receive no anticoagulation']","['composite cardiovascular events, and major bleeding', 'Severe renal insufficiency', 'survival and reduces hospitalizations', 'respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature', 'disseminated intravascular coagulation (ISTH criteria, in-hospital diagnosis', 'Intracerebral bleeding', 'fracture of lower limb, hospitalization for heart failure, hip/knee replacement, major trauma, spinal cord injury, stroke, \u2003b', 'composite of any hospitalization or all-cause death occurring within 30 days of randomization', 'deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0340561', 'cui_str': 'Arterial ischemia'}, {'cui': 'C0025474', 'cui_str': 'Mesenteric'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]",,0.207643,"Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or body temperature","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barco', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Bingisser', 'Affiliation': 'Emergency Department, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Colucci', 'Affiliation': 'Service of Haematology, Clinica Luganese Moncucco, Lugano, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Frenk', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Clinic of Haematology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Mach', 'Affiliation': 'Cardiology Division, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mazzolai', 'Affiliation': 'Department of Angiology, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Righini', 'Affiliation': 'Division of Angiology and Haemostasis, Department of Medical Specialties, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Sebastian', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Spescha', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Stortecky', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kucher', 'Affiliation': 'Clinic of Angiology, University Hospital Zurich, Zurich, Switzerland. nils.kucher@usz.ch.'}]",Trials,['10.1186/s13063-020-04678-4']
2609,32907638,Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The main aim of the study is to evaluate the efficacy of a single dose of sarilumab, in subcutaneous administration, in hospitalised patients with moderate to early severe COVID-19 infection compared to the current standard of care, to prevent progression to systemic hyperinflammatory status. Our hypothesis is that use of subcutaneous sarilumab in early stages (window of opportunity) of COVID-19 moderate-severe pneumonia can prevent higher oxygenation requirements through non-invasive and invasive mechanical ventilation and decrease in-hospital stays, as well as death rate. The secondary objectives of the study are to evaluate the safety of sarilumab through hospitalisation and up to day 14 after discharge, compared to the control arm as assessed by incidence of serious and non serious adverse events (SAEs). In addition, as an exploratory objective, to compare the baseline clinical and biological parameters, including serum IL-6 levels, of the intervention population against controls of the same pandemic outbreak (using a propensity score) to search for markers that identify the best candidates for the treatment with subcutaneous IL-6R inhibitors and to attempt an approximation in the temporal frame of the ""window of opportunity"" TRIAL DESIGN: SARCOVID is an investigator-initiated single center randomised proof of concept study.
PARTICIPANTS


Patients treated at the Hospital Universitario La Princesa, Madrid, Spain requiring hospitalisation will be consecutively recruited, meeting all inclusion criteria and none of the exclusion criteria Inclusion criteria a. Age >18, <80 years old b. COVID-19 infection documented by a positive RT-PCR test or, in absence of a RT-PCR positive test, case definition of COVID 19 infection/pneumonia as per local protocol and the presence of a positive serologic test (IgM/IgA by ELISA) c. Documented interstitial pneumonia requiring admission and at least two of the following parameters: 1) Fever ≥ 37.8°C (tympanic) 2) IL-6 in serum ≥ 25 pg/mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg/dL 3) Lymphocytes <600 cells/mm 3  4) Ferritin> 300 μg/L that doubles in 24 hours 5) Ferritin> 600 μg/L in the first determination and LDH> 250 U/L 6) D-dimer (> 1 mg/L) d. Informed verbal consent or requested under urgent conditions, documented in the electronic medical record. Exclusion criteria a. Patients who require mechanical ventilation at the time of inclusion. b. AST / ALT values > 5 folds the ULN. c. Absolute neutrophil count below 500 cells/mm 3  d. Absolute platelet count below 50,000 cells/mm 3  e. Documented sepsis or high suspicion of superimposed infection by pathogens other than COVID-19. f. Presence of comorbidities that can likely lead to an unfavourable result according to clinical judgment. g. Complicated diverticulitis or intestinal perforation. h. Current skin infection (eg, uncontrolled dermopiodermitis). i. Immunosuppressive anti-rejection therapy. j. Pregnancy or lactation. k. Previous treatment with tocilizumab or sarilumab. l. Patients participating in another clinical trial for SARS-CoV-2 infection. m. Patients with known hypersensitivity or contraindication to sarilumab or excipients.
INTERVENTION AND COMPARATOR


The intervention group, sarilumab plus standard of care, will receive 400 mg single dose treatment with Sarilumab (Kevzara), 2 subcutaneous injections 200mg each in a pre-filled syringe. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed. The control group will receive drugs or procedures in routine clinical practice according to the best standard of care as per local protocol.
MAIN OUTCOMES


Primary Outcome Measures 1. Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7) 1. Death; 2. Hospitalised, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalised, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalised, requiring supplemental oxygen; 5. Hospitalised, not requiring supplemental oxygen - but in need of ongoing medical care (COVID-19 related or otherwise) 6. Hospitalised, not requiring supplemental oxygen - no longer requires ongoing medical care (independent) 7. Not hospitalised 2. Duration of hospitalisation: Days from the date of enrolment to the date of discharge 3. Number of deaths at the end of study RANDOMISATION: Randomisation to treatment arms sarilumab plus standard of care or standard of care in a 2:1 ratio will be performed by the Clinical Research and Clinical Trials Unit (CRCTU) at the Hospital using a table of random numbers, an internet-based randomisation tool. After checking that all inclusion criteria are met and none of the exclusion criteria, CRCTU will communicate the recruiting investigator the assigned treatment.
BLINDING (MASKING)


This study is unblinded.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


30 patients treated by COVID-19 infection who require hospitalisation: 20 will receive sarilumab plus Standard of Care and 10 will receive Standard of Care.
TRIAL STATUS


The Protocol version number is 2, as of 6 th  April 2020, with amendment 1, as of 7 th  May 2020. The recruitment is ongoing. Recruitment started on April 13 th  2020 and is anticipated to be completed by November 2020.
TRIAL REGISTRATION


This trial was first registered in the European Union Clinical Trials Register on 4 April 2020, EudraCT Number 2020-001634-36 . Then, posted on ClinicalTrials.gov on 22 April 2020, Identifier: NCT04357808 .
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the International Council Harmonization guidelines: https://www.ich.org/page/efficacy-guidelines .",2020,Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7) 1.,"['30 patients treated by COVID-19 infection who require hospitalisation: 20 will receive', 'm. Patients with known hypersensitivity or contraindication to sarilumab or excipients', 'l. Patients participating in another clinical trial for SARS-CoV-2 infection', 'Exclusion criteria a. Patients who require mechanical ventilation at the time of inclusion', 'European Union Clinical Trials Register on 4 April 2020, EudraCT Number 2020-001634-36 ', 'Patients treated at the Hospital Universitario La Princesa, Madrid, Spain requiring hospitalisation will be consecutively recruited, meeting all inclusion criteria and none of the exclusion criteria Inclusion criteria a. Age >18, <80 years old b. COVID-19 infection documented by a positive RT-PCR test or, in absence of a RT-PCR positive test, case definition of COVID 19 infection/pneumonia as per local protocol and the presence of a positive serologic test (IgM/IgA by ELISA', 'hospitalised patients with moderate-severe COVID-19 infection', 'hospitalised patients with moderate to early severe COVID-19 infection']","['prednisone', 'tocilizumab or sarilumab', 'sarilumab plus standard of care, will receive 400 mg single dose treatment with Sarilumab (Kevzara), 2 subcutaneous injections 200mg each in a pre-filled syringe', 'sarilumab', 'sarilumab plus Standard of Care and 10 will receive Standard of Care', 'IL-6', 'sarilumab plus standard of care or standard of care', 'LDH', 'invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO', 'subcutaneous IL-6R inhibitors', 'Immunosuppressive anti-rejection therapy', 'Subcutaneous Sarilumab']","['Number of deaths', 'serum IL-6 levels', 'hospital stays', 'Duration of hospitalisation', 'incidence of serious and non serious adverse events (SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0015237', 'cui_str': 'Pharmaceutical excipient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1699800', 'cui_str': 'IL6R protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.221557,Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7) 1.,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Vicuña', 'Affiliation': 'Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain. mariadelrosario.garcia@salud.madrid.org.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Faculty of Medicine, Universidad Autónoma de Madrid (UAM), Madrid, Spain.'}, {'ForeName': 'Isidoro', 'Initials': 'I', 'LastName': 'González-Alvaro', 'Affiliation': 'Rheumatology Department, Hospital Universitario de la Princesa, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramos-Lima', 'Affiliation': 'Medical Affairs Department, Immunology Area, Sanofi Spain, Madrid, Spain.'}, {'ForeName': 'Jesús Sanz', 'Initials': 'JS', 'LastName': 'Sanz', 'Affiliation': 'Instituto de Investigación Sanitaria La Princesa (IIS-IP), Madrid, Spain.'}]",Trials,['10.1186/s13063-020-04588-5']
2610,32907642,School age effects of minding the baby-An attachment-based home-visiting intervention-On parenting and child behaviors.,"Multiple interventions have been developed to improve the caregiver-child relationship as a buffer to the effects of early life adversity and toxic stress. However, relatively few studies have evaluated the long-term effects of these early childhood interventions, particularly on parenting and childhood behaviors. Here we describe the early school-age follow-up results of a randomized controlled trial of Minding the Baby ® (MTB), a reflective, attachment-based, trauma-informed, preventive home-visiting intervention for first-time mothers and their infants. Results indicate that mothers who participated in MTB are less likely to show impaired mentalizing compared to control mothers two to eight years after the intervention ended. Additionally, MTB mothers have lower levels of hostile and coercive parenting, and their children have lower total and externalizing problem behavior scores when compared to controls at follow-up. We discuss our findings in terms of their contribution to understanding the long-term parenting and childhood socio-emotional developmental effects of early preventive interventions for stressed populations.",2020,Results indicate that mothers who participated in MTB are less likely to show impaired mentalizing compared to control mothers two to eight years after the intervention ended.,['first-time mothers and their infants'],['Minding the Baby ® (MTB'],"['levels of hostile and coercive parenting', 'total and externalizing problem behavior scores']","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0320566,Results indicate that mothers who participated in MTB are less likely to show impaired mentalizing compared to control mothers two to eight years after the intervention ended.,"[{'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Londono Tobon', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Condon', 'Affiliation': 'Yale School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Lois S', 'Initials': 'LS', 'LastName': 'Sadler', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Holland', 'Affiliation': 'Yale School of Nursing, New Haven, CT, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Mayes', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Arietta', 'Initials': 'A', 'LastName': 'Slade', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}]",Development and psychopathology,['10.1017/S0954579420000905']
2611,32907904,"Rationale and design of a randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated phase 2a study to investigate the efficacy and safety of elobixibat in combination with cholestyramine for non-alcoholic fatty liver disease.","INTRODUCTION


Non-alcoholic fatty liver disease (NAFLD) pathogenesis involves abnormal metabolism of cholesterol and hepatic accumulation of toxic free-cholesterol. Elobixibat (EXB) inhibits the ileal bile acid (BA) transporter. EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol. In this randomised, double-blind, placebo-controlled, parallel-group, phase IIa study, we aim to provide a proof-of-concept assessment by evaluating the efficacy and safety of EXB in combination with CTM in patients with NAFLD.
METHODS AND ANALYSIS


A total of 100 adult patients with NAFLD, diagnosed based on low-density lipoprotein cholesterol (LDL-C) level of >120 mg/dL and liver fat content of ≥8% by MRI-based proton density fat fraction (MRI-PDFF), who meet the inclusion/exclusion criteria will be enrolled. The patients will be randomly assigned to receive the combination therapy of 10 mg EXB and 9 g CTM powder (4 g CTM), 10 mg EXB monotherapy, 9 g CTM powder monotherapy or a placebo treatment (n=25 per group). Blood tests and MRIs will be performed 16 weeks following treatment initiation. The primary study endpoint will be the absolute LDL-C level change at week 16 after treatment initiation. The exploratory endpoint will include absolute changes in the liver fat fraction as measured by MRI-PDFF. This proof-of-concept study will determine whether the combination therapy of EXB and CTM is effective and safe for patients with NAFLD.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Ethics Committee of Yokohama City University Hospital before participant enrolment. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.
TRIAL REGISTRATION NUMBER


NCT04235205.",2020,"EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol.","['patients with NAFLD', 'non-alcoholic fatty liver disease', '100 adult patients with NAFLD, diagnosed based on low-density lipoprotein cholesterol (LDL-C) level of >120 mg/dL and liver fat content of ≥8% by MRI-based proton density fat fraction (MRI-PDFF), who meet the inclusion/exclusion criteria will be enrolled']","['CTM', 'Elobixibat (EXB', 'placebo', 'EXB and 9 g CTM powder (4 g CTM), 10 mg EXB monotherapy, 9 g CTM powder monotherapy or a placebo treatment', 'EXB and CTM', 'EXB', 'EXB and cholestyramine (CTM', 'cholestyramine']",['absolute LDL-C level change'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0008402', 'cui_str': 'Cholestyramine Resin'}, {'cui': 'C3659266', 'cui_str': 'elobixibat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",100.0,0.392601,"EXB and cholestyramine (CTM) facilitate the removal of free cholesterol from the liver by decreasing BA recirculation to the liver, thereby stimulating novel BA synthesis from cholesterol.","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Saigusa', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine Graduate School of Medicine, Izumo, Shimane, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine Graduate School of Medicine, Izumo, Shimane, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan nakajima-tky@umin.ac.jp.'}]",BMJ open,['10.1136/bmjopen-2020-037961']
2612,32908007,Therapeutic responses to  Roseomonas mucosa  in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair.,"Dysbiosis of the skin microbiota is increasingly implicated as a contributor to the pathogenesis of atopic dermatitis (AD). We previously reported first-in-human safety and clinical activity results from topical application of the commensal skin bacterium  Roseomonas mucosa  for the treatment of AD in 10 adults and 5 children older than 9 years of age. Here, we examined the potential mechanism of action of  R. mucosa  treatment and its impact on children with AD less than 7 years of age, the most common age group for children with AD. In 15 children with AD,  R. mucosa  treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced  Staphylococcus aureus  burden on the skin, and a reduction in topical steroid requirements without severe adverse events. Our observed response rates to  R. mucosa  treatment were greater than those seen in historical placebo control groups in prior AD studies. Skin improvements and colonization by  R. mucosa  persisted for up to 8 months after cessation of treatment. Analyses of cellular scratch assays and the MC903 mouse model of AD suggested that production of sphingolipids by  R. mucosa , cholinergic signaling, and flagellin expression may have contributed to therapeutic impact through induction of a TNFR2-mediated epithelial-to-mesenchymal transition. These results suggest that a randomized, placebo-controlled trial of  R. mucosa  treatment in individuals with AD is warranted and implicate commensals in the maintenance of the skin epithelial barrier.",2020,"In 15 children with AD,  R. mucosa  treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced  Staphylococcus aureus  burden on the skin, and a reduction in topical steroid requirements without severe adverse events.","['children with AD less than 7 years of age, the most common age group for children with AD', 'individuals with AD', '10 adults and 5 children older than 9 years of age']",['placebo'],['epithelial barrier function'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",15.0,0.0436594,"In 15 children with AD,  R. mucosa  treatment was associated with amelioration of disease severity, improvement in epithelial barrier function, reduced  Staphylococcus aureus  burden on the skin, and a reduction in topical steroid requirements without severe adverse events.","[{'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Myles', 'Affiliation': 'Epithelial Therapeutics Unit, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA. mylesi@niaid.nih.gov.'}, {'ForeName': 'Carlo R', 'Initials': 'CR', 'LastName': 'Castillo', 'Affiliation': 'Epithelial Therapeutics Unit, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kent D', 'Initials': 'KD', 'LastName': 'Barbian', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Kishore', 'Initials': 'K', 'LastName': 'Kanakabandi', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Virtaneva', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fitzmeyer', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Paneru', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Otaizo-Carrasquero', 'Affiliation': 'Genomic Technologies Section, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Myers', 'Affiliation': 'Genomic Technologies Section, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Tovah E', 'Initials': 'TE', 'LastName': 'Markowitz', 'Affiliation': 'NIAID Collaborative Bioinformatics Resource (NCBR), NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Ian N', 'Initials': 'IN', 'LastName': 'Moore', 'Affiliation': 'Infectious Disease Pathogenesis Section, Comparative Medicine Branch, NIAID, NIH, Rockville, MD, USA.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Pre-clinical Innovation, National Center for Advancing Translational Sciences, NIH, Rockville, MD, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ferrer', 'Affiliation': 'Department of Pre-clinical Innovation, National Center for Advancing Translational Sciences, NIH, Rockville, MD, USA.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Sakamachi', 'Affiliation': 'National Institute of Environmental Health Sciences, Research Triangle, NC, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Garantziotis', 'Affiliation': 'National Institute of Environmental Health Sciences, Research Triangle, NC, USA.'}, {'ForeName': 'Muthulekha', 'Initials': 'M', 'LastName': 'Swamydas', 'Affiliation': 'Fungal Pathogenesis Section, LCIM, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Michail S', 'Initials': 'MS', 'LastName': 'Lionakis', 'Affiliation': 'Fungal Pathogenesis Section, LCIM, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Anderson', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Noah J', 'Initials': 'NJ', 'LastName': 'Earland', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Sundar', 'Initials': 'S', 'LastName': 'Ganesan', 'Affiliation': 'Biological Imaging Section, Research Technology Branch, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Ashleigh A', 'Initials': 'AA', 'LastName': 'Sun', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Jenna R E', 'Initials': 'JRE', 'LastName': 'Bergerson', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Silverman', 'Affiliation': 'Department of Pediatrics, Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Petersen', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, MD, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Martens', 'Affiliation': 'RTS Genomics Unit, Rocky Mountain Laboratories, NIAID, NIH, Hamilton, MT, USA.'}, {'ForeName': 'Sandip K', 'Initials': 'SK', 'LastName': 'Datta', 'Affiliation': 'Laboratory of Clinical Immunology and Microbiology, NIAID, NIH, Bethesda, MD, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aaz8631']
2613,32908018,"""Someone's Got My Back"": Older People's Experience of the Coaching for Healthy Ageing Program for Promoting Physical Activity and Preventing Falls.","The Coaching for Healthy Ageing trial evaluated the impact on physical activity (PA) and falls based on a year-long intervention in which participants aged 60+ receive a home visit, regular health coaching by physiotherapists, and a free activity monitor. This interview study describes the participants' experiences of the intervention and ideas for improvement. The authors sampled purposively for maximum variation in experiences. The data were analyzed thematically by two researchers. Most of the 32 participants reported that the intervention increased PA levels, embedded activities, and generated positivity about PA. They were motivated by quantified PA feedback, self-directed goals, and person-centered coaching. Social connectivity motivated some, but the intervention did not support this well. The intervention structure allowed participants to trial and embed activities. Autonomy and relatedness were emphasized and should be included in future program theory. The authors identified synergistic effects, likely ""essential ingredients,"" and potential areas for improving this and similar interventions.",2020,"Most of the 32 participants reported that the intervention increased PA levels, embedded activities, and generated positivity about PA.",['participants aged 60+ receive a'],"['home visit, regular health coaching by physiotherapists, and a free activity monitor']","['PA levels, embedded activities, and generated positivity about PA']","[{'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0173721,"Most of the 32 participants reported that the intervention increased PA levels, embedded activities, and generated positivity about PA.","[{'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': ''}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Wallbank', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lester', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Dafna', 'Initials': 'D', 'LastName': 'Merom', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rissel', 'Affiliation': ''}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0116']
2614,32908159,"Comparing the visual outcome, visual quality, and satisfaction among three types of multi-focal intraocular lenses.","This study compared the visual outcome, visual quality, and satisfaction following implantation of the Mix-and-Match bifocal IOLs (+ 2.75 D and + 3.25 D add power Tecnis Multifocal Model), EDOF IOL (Tecnis Symfony IOL), and Trifocal IOL (FineVision PodFT, PhysIOL). All outcomes were compared among the three groups. The manifest refraction indicated that the EDOF group had significantly higher myopic spherical equivalent values than did the others. In the terms of visual acuity, there were no significant differences in far or intermediate visual acuity among the three groups. Only in near (33 cm), the EDOF group had significantly worse binocular visual acuity than did the Trifocal group (p = 0.002). Regarding to defocus curve, the Trifocal group had better defocus curves at near distances (- 2.0 to - 3.5 D; p = 0.001 vs. EDOF) than did the other two groups. In contrast sensitivity test, the EDOF group had relatively lower value than did the other two groups. In reading speed, only at 0.3 logMAR (6.5-point font), Mix-and-Match group had a significantly higher reading speed than did the other two groups (p =  < 0.001 vs. EDOF, p = 0.007 vs. Trifocal). also Mix-and-Match group showed significantly fewer visual artifacts. There were no differences between the three groups in terms of patient satisfaction.ClinicalTrials.gov number: NCT04019691.",2020,There were no differences between the three groups in terms of patient satisfaction.,[],['EDOF'],"['intermediate visual acuity', 'power Tecnis Multifocal Model), EDOF IOL (Tecnis Symfony IOL), and Trifocal IOL (FineVision PodFT, PhysIOL', 'visual outcome, visual quality, and satisfaction', 'reading speed', 'patient satisfaction', 'myopic spherical equivalent values', 'visual acuity', 'visual artifacts', 'binocular visual acuity', 'visual outcome, visual quality, and satisfaction following implantation of the Mix-and-Match bifocal IOLs', 'manifest refraction']",[],[],"[{'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}]",,0.0338072,There were no differences between the three groups in terms of patient satisfaction.,"[{'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Paik', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Sang', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, The Graduate School, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Chan Min', 'Initials': 'CM', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Hui', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea. ldhlse@gmail.com.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea. tychung@skku.edu.'}]",Scientific reports,['10.1038/s41598-020-69318-y']
2615,32908173,Effectiveness and moderators of individual cognitive behavioral therapy versus treatment as usual in clinically depressed adolescents: a randomized controlled trial.,"We examined if manualized cognitive behavioral therapy (CBT) was more effective than Treatment As Usual (TAU) for clinically depressed adolescents within routine care. This multisite Randomized controlled trail included 88 clinically depressed adolescents (aged 12-21 years) randomly assigned to CBT or TAU. Multiple assessments (pre-, post treatment and six-month follow-up) were done using semi-structured interviews, questionnaires and ratings and multiple informants. The primary outcome was depressive or dysthymic disorder based on the KSADS. Completers, CBT (n = 19) and TAU (n = 26), showed a significant reduction of affective diagnoses at post treatment (76% versus 76%) and after six months (90% versus 79%). Intention-to-treat analyses on depressive symptoms showed that 41.6% within CBT and 31.8% within the TAU condition was below clinical cut-off at post treatment and after six-months, respectively 61.4% and 47.7%. No significant differences in self-reported depressive symptoms between CBT and TAU were found. No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression. We conclude that CBT did not outperform TAU in clinical practice in the Netherlands. Both treatments were found to be suitable to treat clinically referred depressed adolescents. CBT needs further improvement to decrease symptom levels below the clinical cut-off at post treatment.",2020,"No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression.","['clinically depressed adolescents', 'clinically depressed adolescents within routine care', '88 clinically depressed adolescents (aged 12-21\xa0years']","['CBT', 'manualized cognitive behavioral therapy (CBT', 'individual cognitive behavioral therapy', 'CBT or TAU']","['self-reported depressive symptoms', 'affective diagnoses', 'depressive or dysthymic disorder based on the KSADS', 'depressive symptoms', 'symptom levels']","[{'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013415', 'cui_str': 'Dysthymia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",88.0,0.0542196,"No prediction or moderation effects were found for age, gender, child/parent educational level, suicidal criteria, comorbidity, and severity of depression.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Stikkelbroek', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands. y.stikkelbroek@uu.nl.'}, {'ForeName': 'Gerko', 'Initials': 'G', 'LastName': 'Vink', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands.'}, {'ForeName': 'Maaike H', 'Initials': 'MH', 'LastName': 'Nauta', 'Affiliation': 'Faculty of Behavioral and Social Sciences, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Bottelier', 'Affiliation': 'Center for Child and Youth Psychiatry, Triversum, The Netherlands.'}, {'ForeName': 'Leonieke J J', 'Initials': 'LJJ', 'LastName': 'Vet', 'Affiliation': 'Child Study Center, Accare, The Netherlands.'}, {'ForeName': 'Cathelijne M', 'Initials': 'CM', 'LastName': 'Lont', 'Affiliation': 'Child and Youth Psychiatry, Altrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Anneloes L', 'Initials': 'AL', 'LastName': 'van Baar', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands.'}, {'ForeName': 'Denise H M', 'Initials': 'DHM', 'LastName': 'Bodden', 'Affiliation': 'Child and Adolescent Studies, Utrecht University, PO Box 80.140, 3508 TC, Utrecht, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-71160-1']
2616,32908483,Mindfulness Training Enhances Endurance Performance and Executive Functions in Athletes: An Event-Related Potential Study.,"Mindfulness interventions have been linked to improved sport performance and executive functions; however, few studies have explored the effects of mindfulness on sport performance and executive functions simultaneously. This study sought to examine whether a mindfulness training program would affect both the endurance performance and executive functions of athletes. In addition, event-related potentials (ERPs) associated with the Stroop task were assessed to investigate the potential electrophysiological activation associated with the mindfulness training. Applying a quasiexperimental design, forty-six university athletes were recruited and assigned into a five-week mindfulness training program or a waiting list control group. For each participant, the mindfulness level, endurance performance assessed by a graded exercise test, executive functions assessed via Stroop task, and N2 component of ERPs were measured prior to and following the 5-week intervention. After adjusting for the preintervention scores as a covariate, it was found that the postintervention mindfulness level, exhaustion time, and Stroop task accuracy scores, regardless of task condition, of the mindfulness group were higher than those of the control group. The mindfulness group also exhibited a smaller N2 amplitude than the control group. These results suggest that the five-week mindfulness program can enhance the mindfulness level, endurance performance, and multiple cognitive functions, including executive functions, of university athletes. Mindfulness training may also reduce conflict monitoring in neural processes.",2020,The mindfulness group also exhibited a smaller N2 amplitude than the control group.,"['Athletes', 'forty-six university athletes', 'athletes']","['mindfulness training program or a waiting list control group', 'Mindfulness training', 'Mindfulness Training', 'mindfulness training program']","['mindfulness level, endurance performance assessed by a graded exercise test, executive functions assessed via Stroop task, and N2 component of ERPs', 'mindfulness level, endurance performance, and multiple cognitive functions, including executive functions, of university athletes', 'Endurance Performance and Executive Functions', 'postintervention mindfulness level, exhaustion time, and Stroop task accuracy scores, regardless of task condition']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",46.0,0.00975068,The mindfulness group also exhibited a smaller N2 amplitude than the control group.,"[{'ForeName': 'Jui-Ti', 'Initials': 'JT', 'LastName': 'Nien', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan City, Taiwan.'}, {'ForeName': 'Chih-Han', 'Initials': 'CH', 'LastName': 'Wu', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan City, Taiwan.'}, {'ForeName': 'Kao-Teng', 'Initials': 'KT', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan City, Taiwan.'}, {'ForeName': 'Yu-Min', 'Initials': 'YM', 'LastName': 'Cho', 'Affiliation': 'Center for East-West Medicine, David Geffen School of Medicine, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Chien-Heng', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Chenglin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}]",Neural plasticity,['10.1155/2020/8213710']
2617,32908493,"The Efficacy of Amniotic Membrane Stem Cell (AMSC) Metabolite Product and Vitamin E for Wrinkles, Spots, and Pores in Photoaging.","Background


It is expected that a combination of amniotic membrane stem cell metabolite product (AMSC-MP) and vitamin E after fractional CO 2  laser as laser-assisted drug delivery (LADD) will provide better effects in photoaging treatment as the combination reaches the target. This promises an option for photoaging therapy in the future.
Materials and Methods


Sixty women with photoaged skins were involved in this experimental study. They were then divided into two groups. The treatment group received a topical combination of AMSC-MP and vitamin E, and the control group received AMSC-MP alone after fractional CO 2  laser. The treatment was repeated three times.
Result


The Janus assessment results showed a significant difference in pores in the third observation, and the average pore improvements in the treatment group were better than the control group. Wrinkle, UV spot, and polar spot did not show any significant difference.
Conclusion


A combination of the amniotic membrane stem cell metabolite product (AMSC-MP) and vitamin E after fractional CO 2  laser as LADD only improves pores in photoaged skins.",2020,"Wrinkle, UV spot, and polar spot did not show any significant difference.
",['Sixty women with photoaged skins'],"['Amniotic Membrane Stem Cell (AMSC) Metabolite Product and Vitamin E', 'amniotic membrane stem cell metabolite product (AMSC-MP) and vitamin E', 'topical combination of AMSC-MP and vitamin E, and the control group received AMSC-MP alone after fractional CO 2  laser']","['average pore improvements', 'Wrinkle, UV spot, and polar spot']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",60.0,0.0423801,"Wrinkle, UV spot, and polar spot did not show any significant difference.
","[{'ForeName': 'Rahmadewi', 'Initials': 'R', 'LastName': 'Rahmadewi', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Retha', 'Initials': 'R', 'LastName': 'Retha', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Dyah Ayu', 'Initials': 'DA', 'LastName': 'Pitasari', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Vidyani Adiningtyas', 'Initials': 'VA', 'LastName': 'Kusumastanto', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Agatha Anindita Ayu', 'Initials': 'AAA', 'LastName': 'Ardhaninggar', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Irmadita', 'Initials': 'I', 'LastName': 'Citrashanty', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Maylita', 'Initials': 'M', 'LastName': 'Sari', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Menul Ayu', 'Initials': 'MA', 'LastName': 'Umborowati', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}, {'ForeName': 'Cita Rosita Sigit', 'Initials': 'CRS', 'LastName': 'Prakoeswa', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Universitas Airlangga-Dr. Soetomo Teaching Hospital, Surabaya, Indonesia.'}]",Dermatology research and practice,['10.1155/2020/1584541']
2618,32908496,Randomized Controlled Trial of Polyethylene Glycol versus Oral Sodium Phosphate for Bowel Preparation in Unsedated Colonoscopy.,"Aim


To identify the most effective laxative for bowel preparation in unsedated colonoscopy.
Methods


Between April 2019 and April 2020, a total of 586 outpatients scheduled for unsedated colonoscopy at the First Hospital of Jilin University (Changchun, China) were randomized into one of two groups, namely, the polyethylene glycol (PEG) group or the oral sodium phosphate solution (OSP) group. The cleaning efficiency and other relevant clinical parameters were compared between the two groups.
Results


Each group consisted of 293 patients. There were no significant differences in gender, body mass index, and history of abdominal surgery between the two groups. There were more cases of laxative intolerance in the PEG group than in the OSP group (7.5% vs. 0.7%,  P  < 0.05). After tube insertion, we found that the cleaning efficiency of OSP was better than that of PEG ( P  < 0.05). After cleaning, there was no significant difference in bowel cleanliness between the two groups ( P  > 0.05). The colonoscopic insertion time of the PEG group was significantly shorter than that of the OSP group (10.0 vs. 12.0 min,  P  = 0.002), and colonoscopic insertion was more difficult in the OSP group than in the PEG group ( P  = 0.036). The VAS score of the PEG group patients was significantly lower than that of OSP group patients (4.0 ± 1.3 vs. 5.2 ± 1.7,  P  ≤ 0.001). There were no significant differences in the cecal intubation rate and the detection rate of polyps and ulcers/erosion between the two groups.
Conclusion


The cleaning efficiency and tolerability of OSP were preferable to those of PEG, but there was no significant difference in bowel cleanliness after washing the colon and suctioning the fluid. Compared with patients of the OSP group, those of the PEG group required a shorter colonoscopic insertion time and reported a more comfortable experience. Therefore, for cases that are tolerant of PEG, PEG is a better choice for unsedated colonoscopy.",2020,"There were no significant differences in the cecal intubation rate and the detection rate of polyps and ulcers/erosion between the two groups.
","['Methods\n\n\nBetween April 2019 and April 2020, a total of 586 outpatients scheduled for unsedated colonoscopy at the First Hospital of Jilin University', '293 patients', 'Unsedated Colonoscopy']","['Polyethylene Glycol versus Oral Sodium Phosphate', 'polyethylene glycol (PEG) group or the oral sodium phosphate solution (OSP', 'OSP']","['colonoscopic insertion time', 'cecal intubation rate and the detection rate of polyps and ulcers/erosion', 'bowel cleanliness', 'VAS score', 'laxative intolerance', 'colonoscopic insertion', 'cleaning efficiency', 'cleaning efficiency of OSP', 'cleaning efficiency and tolerability of OSP', 'gender, body mass index, and history of abdominal surgery']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0522513', 'cui_str': 'With cleanliness'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0074757', 'cui_str': 'sodium phosphate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]",586.0,0.0212255,"There were no significant differences in the cecal intubation rate and the detection rate of polyps and ulcers/erosion between the two groups.
","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun, China 130021.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Tao', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun, China 130021.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun, China 130021.'}, {'ForeName': 'Luping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun, China 130021.'}, {'ForeName': 'Qingying', 'Initials': 'Q', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun, China 130021.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, The First Hospital of Jilin University, No. 1 Xinmin Street, Changchun, China 130021.'}]",Gastroenterology research and practice,['10.1155/2020/6457079']
2619,32908497,Effectiveness of Leg Elevation to Prevent Spinal Anesthesia-Induced Hypotension during Cesarean Delivery in the Resource-Limited Area: Open Randomized Controlled Trial.,"Background


Postspinal hypotension is the most common complication after spinal anesthesia for cesarean section (CS). Hypotension mainly occurs due to the reductions of vascular tone leading to decreased systemic vascular resistance and decreased venous return. The aim of this study was to assess the effectiveness of leg elevation (LE) as a method of prevention of postspinal hypotension in patients who undergo cesarean section under spinal anesthesia.
Methods


This is a single-center parallel-randomized controlled trial study, and 52 full-term parturients scheduled for elective cesarean section who meets inclusion criteria were included in the study. The randomization sequence was created by a researcher not participating in patient management using a computer random generator. The participant was randomly assigned to the leg elevation group ( n  = 26) or to the control group ( n  = 26) of usual perioperative care.
Results


The proportions of patients who develop hypotension are lower (8 (33.3%)) in the leg elevation group than the control group (15 (62.5%)) with an  X   2  (1,  N  = 48) = 4.09,  P =0.043. The relative risk of developing postspinal hypotension in the leg elevation group compared to the control group was 0.47 (95% CI, 0.28-1.00). The proportion of severe hypotension was significantly decreased in the leg elevation group at a  P  value of 0.02.
Conclusion


Performing leg elevation immediately after spinal anesthesia reduced the incidence of hypotension. The trial is registered with PACTR201908713181850.",2020,"The proportions of patients who develop hypotension are lower (8 (33.3%)) in the leg elevation group than the control group (15 (62.5%)) with an  X   2  (1,  N  = 48) = 4.09,  P =0.043.","['patients who undergo cesarean section under spinal anesthesia', '52 full-term parturients scheduled for elective cesarean section who meets inclusion criteria were included in the study']","['Leg Elevation', 'Spinal Anesthesia-Induced Hypotension', 'leg elevation group ( n \u2009=\u200926) or to the control group ( n \u2009=\u200926) of usual perioperative care', 'leg elevation (LE']","['develop hypotension', 'incidence of hypotension', 'proportion of severe hypotension', 'relative risk of developing postspinal hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150706', 'cui_str': 'Perioperative care'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.0985075,"The proportions of patients who develop hypotension are lower (8 (33.3%)) in the leg elevation group than the control group (15 (62.5%)) with an  X   2  (1,  N  = 48) = 4.09,  P =0.043.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Assen', 'Affiliation': 'Department of Anesthesia, College of Medicine and Health Sciences, Dilla University, Dilla, Ethiopia.'}, {'ForeName': 'Bedru', 'Initials': 'B', 'LastName': 'Jemal', 'Affiliation': 'Department of Anesthesia, College of Medicine and Health Sciences, Dilla University, Dilla, Ethiopia.'}, {'ForeName': 'Adane', 'Initials': 'A', 'LastName': 'Tesfaye', 'Affiliation': 'Department of Public Health, College of Medicine and Health Sciences, Dilla University, Dilla, Ethiopia.'}]",Anesthesiology research and practice,['10.1155/2020/5014916']
2620,32908536,Evaluation Effects of Laser Therapy and Extracorporeal Shock Wave Therapy with Clinical Parameters and Magnetic Resonance Imaging for Treatment of Plantar Fasciitis in Patients with Spondyloarthritis: A Randomized Controlled Trial.,"Objective


Low-level laser therapy (LLLT) and extracorporeal shock wave therapy (ESWT) is applied in the conservative treatment of inflammatory plantar fasciitis, which is also a characteristic feature of spondyloarthritis (SpA) (Gill, 1997 and Roxas, 2005). We determined and compared the effectiveness of LLLT and ESWT using magnetic resonance imaging (MRI).
Methods


This study is a prospective, randomized, comparative, single-blind clinical study. Voluntarily followed 40 patients with the diagnosis of SpA and having pain at the heels at least for 6 months. Patients were divided randomly into two treatment groups. One group undertook 14 sessions of infrared Ga-Al-As LLLT, and the other group undertook 3 sessions ESWT. Feet functions of the patients were evaluated by American Orthopaedic Foot and Ankle Society (AOFAS) and Roles and Maudsley Scoring; VAS was evaluated for foot pain and function. In clinical assessment, disease activity was carried out by applying the BASDAI, the functional assessment was evaluated through the BASFI, and the patient quality of life was evaluated through the ASQoL; enthesitis was scored according to MASES assessment, performed before and at 1 month after treatment. The thickness of the plantar fascia was measured with MRI before and 1 month after treatment.
Results


Compared with the pretherapy, progress in the feet function by AOFAS and Roles-Maudsley scoring and decrease in VAS levels were statistically significant in both groups ( p  < 0.001). Only the VAS exercise score was superior to LLLT ( p  < 0.05). The thickness of the plantar fascia had decreased significantly on MRI in all two groups.
Conclusion


The treatment of plantar fasciitis with LLLT and ESWT was more successful in pain improvement and functional outcomes with the dose, frequency, and duration used in our study.",2020,Only the VAS exercise score was superior to LLLT ( p  < 0.05).,"['Patients with Spondyloarthritis', '40 patients with the diagnosis of SpA and having pain at the heels at least for 6 months']","['infrared Ga-Al-As LLLT', 'LLLT and ESWT', 'Magnetic Resonance Imaging', 'Low-level laser therapy (LLLT) and extracorporeal shock wave therapy (ESWT', 'LLLT and ESWT using magnetic resonance imaging (MRI', 'Laser Therapy and Extracorporeal Shock Wave Therapy']","['disease activity', 'VAS levels', 'Plantar Fasciitis', 'American Orthopaedic Foot and Ankle Society (AOFAS) and Roles and Maudsley Scoring; VAS', 'MRI', 'VAS exercise score', 'thickness of the plantar fascia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}]",40.0,0.0249749,Only the VAS exercise score was superior to LLLT ( p  < 0.05).,"[{'ForeName': 'Kezban', 'Initials': 'K', 'LastName': 'Armagan Alpturker', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Division of Rheumatology, Celal Bayar University Medical School, Manisa, Turkey.'}, {'ForeName': 'Ayse Beyhan Lale', 'Initials': 'ABL', 'LastName': 'Cerrahoglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Celal Bayar University Medical School, Manisa, Turkey.'}, {'ForeName': 'Ihsan Sebnem', 'Initials': 'IS', 'LastName': 'Orguc', 'Affiliation': 'Department of Radiodiagnostics, Celal Bayar University Medical School, Manisa, Turkey.'}]",International journal of rheumatology,['10.1155/2020/4386361']
2621,32908546,Dental Pulp Mesenchymal Stem Cells as a Treatment for Periodontal Disease in Older Adults.,"Periodontal disease (PD) is one of the main causes of tooth loss and is related to oxidative stress and chronic inflammation. Although different treatments have been proposed in the past, the vast majority do not regenerate lost tissues. In this sense, the use of dental pulp mesenchymal stem cells (DPMSCs) seems to be an alternative for the regeneration of periodontal bone tissue. A quasi-experimental study was conducted in a sample of 22 adults between 55 and 64 years of age with PD, without uncontrolled systemic chronic diseases. Two groups were formed randomly: (i) experimental group (EG)  n  = 11, with a treatment based on DPMSCs; and a (ii) control group (CG)  n  = 11, without a treatment of DPMSCs. Every participant underwent clinical and radiological evaluations and measurement of bone mineral density (BMD) by tomography. Saliva samples were taken as well, to determine the total concentration of antioxidants, superoxide dismutase (SOD), lipoperoxides, and interleukins (IL), before and 6 months after treatment. All subjects underwent curettage and periodontal surgery, the EG had a collagen scaffold treated with DPMSCs, while the CG only had the collagen scaffold placed. The EG with DPMSCs showed an increase in the BMD of the alveolar bone with a borderline statistical significance (baseline 638.82 ± 181.7 vs. posttreatment 781.26 ± 162.2 HU,  p  = 0.09). Regarding oxidative stress and inflammation markers, salivary SOD levels were significantly higher in EG (baseline 1.49 ± 0.96 vs. 2.14 ± 1.12 U/L posttreatment,  p  < 0.05) meanwhile IL1 β  levels had a decrease (baseline 1001.91 ± 675.5 vs.  posttreatment 722.3 ± 349.4 pg/ml,  p  < 0.05). Our findings suggest that a DPMSCs treatment based on DPMSCs has both an effect on bone regeneration linked to an increased SOD and decreased levels of IL1 β  in aging subjects with PD.",2020,"The EG with DPMSCs showed an increase in the BMD of the alveolar bone with a borderline statistical significance (baseline 638.82 ± 181.7 vs. posttreatment 781.26 ± 162.2 HU,  p  = 0.09).","['22 adults between 55 and 64 years of age with PD, without uncontrolled systemic chronic diseases', 'Older Adults']","['dental pulp mesenchymal stem cells (DPMSCs', 'Dental Pulp Mesenchymal Stem Cells', 'experimental group (EG)  n  = 11, with a treatment based on DPMSCs; and a (ii) control group (CG)  n  = 11, without a treatment of DPMSCs']","['total concentration of antioxidants, superoxide dismutase (SOD), lipoperoxides, and interleukins (IL', 'BMD of the alveolar bone', 'bone mineral density (BMD', 'oxidative stress and inflammation markers, salivary SOD levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031090', 'cui_str': 'Periodontal disease'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",22.0,0.0242152,"The EG with DPMSCs showed an increase in the BMD of the alveolar bone with a borderline statistical significance (baseline 638.82 ± 181.7 vs. posttreatment 781.26 ± 162.2 HU,  p  = 0.09).","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Hernández-Monjaraz', 'Affiliation': 'Research Unit on Gerontology, FES Zaragoza, National Autonomous University of Mexico, 09230 Mexico City, Mexico.'}, {'ForeName': 'Edelmiro', 'Initials': 'E', 'LastName': 'Santiago-Osorio', 'Affiliation': 'Haematopoiesis and Leukaemia Laboratory, Research Unit on Cell Differentiation and Cancer, FES Zaragoza, National Autonomous University of Mexico, 09230 Mexico City, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Ledesma-Martínez', 'Affiliation': 'Haematopoiesis and Leukaemia Laboratory, Research Unit on Cell Differentiation and Cancer, FES Zaragoza, National Autonomous University of Mexico, 09230 Mexico City, Mexico.'}, {'ForeName': 'Itzen', 'Initials': 'I', 'LastName': 'Aguiñiga-Sánchez', 'Affiliation': 'Haematopoiesis and Leukaemia Laboratory, Research Unit on Cell Differentiation and Cancer, FES Zaragoza, National Autonomous University of Mexico, 09230 Mexico City, Mexico.'}, {'ForeName': 'Norma Angélica', 'Initials': 'NA', 'LastName': 'Sosa-Hernández', 'Affiliation': 'Haematopoiesis and Leukaemia Laboratory, Research Unit on Cell Differentiation and Cancer, FES Zaragoza, National Autonomous University of Mexico, 09230 Mexico City, Mexico.'}, {'ForeName': 'Víctor Manuel', 'Initials': 'VM', 'LastName': 'Mendoza-Núñez', 'Affiliation': 'Research Unit on Gerontology, FES Zaragoza, National Autonomous University of Mexico, 09230 Mexico City, Mexico.'}]",Stem cells international,['10.1155/2020/8890873']
2622,32908554,Effects of Wuqinxi in the Patients with Chronic Low Back Pain: A Randomized Controlled Trial.,"Low back pain (LBP) is one of the major concerns of the current health care. The guidelines for chronic LBP recommend traditional Chinese exercise as an effective treatment. As one of the representatives of traditional Chinese exercise, Wuqinxi has been famous in China for its effects on improving health and treating chronic diseases for thousands of years. The objectives of the study were to assess the effects of Wuqinxi in the patients with chronic LBP on pain intensity, trunk muscle strength, and quality of life. The primary outcome measure was assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ), including the Visual Analog Scale (VAS) and Present Pain Intensity (PPI) as the subtables. The effects of Wuqinxi on the quality of life were also assessed by the Short-Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) from physical component summary (PCS), mental component summary (MCS), and sleep quality. Besides, the electrical activities of the rectus abdominis (RA), obliquus externus abdominis (OEA), lumbar erector spinae (ES), and multifidus (MF) were assessed by integrated electromyogram (iEMG) after the end of the intervention. Both the groups showed statistically significant improvement in SF-MPQ, SF-36, PSQI, and iEMG at 12 weeks and 24 weeks when compared with baseline ( P  < 0.05). However, Wuqinxi demonstrated better effects in SF-MPQ and MCS after 24 weeks of intervention compared with the general exercise ( P  < 0.05). The patients in the Wuqinxi group (WQXG) also showed a significantly higher iEMG on OEA than the general exercise group (GEG) in 30°/s and 90°/s ( P  < 0.05). Our results showed that Wuqinxi had better effects on chronic LBP for a long time compared with general exercise, including pain intensity and quality of life. Thus, Wuqinxi should be recognized as a possible standalone therapy and self-management skill in chronic LBP, which is suitable for long-term practice.",2020,"Both the groups showed statistically significant improvement in SF-MPQ, SF-36, PSQI, and iEMG at 12 weeks and 24 weeks when compared with baseline ( P  < 0.05).","['Patients with Chronic Low Back Pain', 'patients with chronic LBP on']","['Wuqinxi', 'Wuqinxi group (WQXG', 'traditional Chinese exercise']","['pain intensity, trunk muscle strength, and quality of life', 'SF-MPQ, SF-36, PSQI, and iEMG', 'electrical activities of the rectus abdominis (RA), obliquus externus abdominis (OEA), lumbar erector spinae (ES), and multifidus (MF', 'pain intensity and quality of life', 'chronic LBP', 'Short-Form McGill Pain Questionnaire (SF-MPQ), including the Visual Analog Scale (VAS) and Present Pain Intensity (PPI) as the subtables', 'Low back pain (LBP', 'iEMG on OEA', 'quality of life', 'SF-MPQ and MCS', 'Short-Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) from physical component summary (PCS), mental component summary (MCS), and sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0222826,"Both the groups showed statistically significant improvement in SF-MPQ, SF-36, PSQI, and iEMG at 12 weeks and 24 weeks when compared with baseline ( P  < 0.05).","[{'ForeName': 'Chongjie', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 Ganhe Road, Hongkou District, Shanghai 200437, China.'}, {'ForeName': 'Zhenrui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200 Cai Lun Road, Pudong New District, Shanghai 201203, China.'}, {'ForeName': 'Shuaipan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 Ganhe Road, Hongkou District, Shanghai 200437, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 Ganhe Road, Hongkou District, Shanghai 200437, China.'}, {'ForeName': 'Qingguang', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, No. 110 Ganhe Road, Hongkou District, Shanghai 200437, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, No. 1200 Cai Lun Road, Pudong New District, Shanghai 201203, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/1428246']
2623,32912091,Factors Associated With Participation in the Chronic Disease Self-Management Program: Findings From the SUCCEED Trial.,"BACKGROUND AND PURPOSE


Self-management programs may improve quality of life and self-efficacy for stroke survivors, but participation is low. In a randomized controlled trial of a complex, multidisciplinary, team-based secondary stroke prevention intervention, we offered participants Chronic Disease Self-Management Program (CDSMP) workshops in addition to clinic visits and home visits. To enhance participation, workshops were facilitated by community health workers who were culturally and linguistically concordant with most participants and scheduled CDSMP sessions at convenient venues and times. Over time, we implemented additional strategies such as free transportation and financial incentives. In this study, we aimed to determine factors associated with CDSMP participation and attendance.
METHODS


From 2014 to 2018, 18 CDSMP workshop series were offered to 241 English and Spanish-speaking individuals (age ≥40 years) with recent stroke or transient ischemic attack. Zero-inflated Poisson regression was used to identify factors associated with participation and attendance (ie, number of sessions attended) in CDSMP. Missing values were imputed using multiple imputation methods.
RESULTS


Nearly one-third (29%) of intervention subjects participated in CDSMP. Moderate disability and more clinic/home visits were associated with participation. Participants with higher numbers of clinic and home visits (incidence rate ratio [IRR], 1.06 [95% CI, 1.01-1.12]), severe (IRR, 2.34 [95% CI, 1.65-3.31]), and moderately severe disability (IRR, 1.55 [95% CI, 1.07-2.23]), and who enrolled later in the study (IRR, 1.12 [95% CI, 1.08-1.16]) attended more sessions. Individuals with higher chaos scores attended fewer sessions (IRR, 0.97 [95% CI, 0.95-0.99]).
CONCLUSIONS


Less than one-third of subjects enrolled in the SUCCEED (Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities) intervention participated in CDSMP; however, participation improved as transportation and financial barriers were addressed. Strategies to address social determinants of health contributing to chaos and engage individuals in healthcare may facilitate attendance.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01763203.",2020,"Participants with higher numbers of clinic and home visits (incidence rate ratio [IRR], 1.06 [95% CI, 1.01-1.12]), severe (IRR, 2.34 [95% CI, 1.65-3.31]), and moderately severe disability (IRR, 1.55 [95% CI, 1.07-2.23]), and who enrolled later in the study (IRR, 1.12 [95% CI, 1.08-1.16]) attended more sessions.","['From 2014 to 2018, 18 CDSMP workshop series were offered to 241 English and Spanish-speaking individuals (age ≥40 years) with recent stroke or transient ischemic attack', 'Chronic Disease Self-Management Program', 'participants Chronic Disease Self-Management Program (CDSMP) workshops in addition to clinic visits and home visits']","['complex, multidisciplinary, team-based secondary stroke prevention intervention']","['quality of life and self-efficacy', 'Moderate disability and more clinic/home visits', 'severe disability']","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1277289', 'cui_str': 'Stroke prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.0711493,"Participants with higher numbers of clinic and home visits (incidence rate ratio [IRR], 1.06 [95% CI, 1.01-1.12]), severe (IRR, 2.34 [95% CI, 1.65-3.31]), and moderately severe disability (IRR, 1.55 [95% CI, 1.07-2.23]), and who enrolled later in the study (IRR, 1.12 [95% CI, 1.08-1.16]) attended more sessions.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles. (A.M.L., M.A.-R., T.S.-T., N.S., A.T.).'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York (B.G.V.).'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'Department of Neurology, University of California, Los Angeles. (F.B., M.L.L., B.M.).'}, {'ForeName': 'Martin L', 'Initials': 'ML', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, University of California, Los Angeles. (F.B., M.L.L., B.M.).'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Ayala-Rivera', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles. (A.M.L., M.A.-R., T.S.-T., N.S., A.T.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': 'VA Greater Los Angeles Healthcare System, CA (M.L.L., E.C.).'}, {'ForeName': 'Ana V', 'Initials': 'AV', 'LastName': 'Montoya', 'Affiliation': 'Department of Neurology, Harbor-UCLA Medical Center, Torrance, CA (A.V.M., J.L.T., B.M.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mojarro-Huang', 'Affiliation': 'Department of Neurology, LAC+USC Medical Center, Los Angeles. (M.A.-R., E.M.-H., M.C., N.S., A.T.).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Neurology, LAC+USC Medical Center, Los Angeles. (M.A.-R., E.M.-H., M.C., N.S., A.T.).'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Corrales', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Sivers-Teixeira', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles. (A.M.L., M.A.-R., T.S.-T., N.S., A.T.).'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Tran', 'Affiliation': 'Department of Neurology, Harbor-UCLA Medical Center, Torrance, CA (A.V.M., J.L.T., B.M.).'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Ediss', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Shaby', 'Affiliation': 'Department of Neurology, Olive View-UCLA Medical Center, Sylmar, CA. (B.S.).'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Willis', 'Affiliation': 'Watts Labor Community Action Committee, Los Angeles, CA (P.W.).'}, {'ForeName': 'Nerses', 'Initials': 'N', 'LastName': 'Sanossian', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles. (A.M.L., M.A.-R., T.S.-T., N.S., A.T.).'}, {'ForeName': 'Bijal', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'Department of Neurology, University of California, Los Angeles. (F.B., M.L.L., B.M.).'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Dutta', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Razmara', 'Affiliation': 'Department of Neurology, Rancho Los Amigos National Rehabilitation Center, Downey, CA (M.A.-R., P.G., M.C., M.C., T.S.-T., R.J., C.E., A.T., T.D., A.R.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bryg', 'Affiliation': 'Department of Medicine, University of California, Los Angeles. (R.B.).'}, {'ForeName': 'Shlee', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA (S.S.).'}, {'ForeName': 'Amytis', 'Initials': 'A', 'LastName': 'Towfighi', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles. (A.M.L., M.A.-R., T.S.-T., N.S., A.T.).'}]",Stroke,['10.1161/STROKEAHA.119.028022']
2624,32912157,Phosphodiesterase 5 inhibitor sildenafil in patients with heart failure with preserved ejection fraction and combined pre- and postcapillary pulmonary hypertension: a randomized open-label pilot study.,"BACKGROUND


Heart failure with preserved ejection fraction (HFpEF) is frequently complicated by pulmonary hypertension (PH). A pulmonary vascular contribution could be considered as a substantial therapeutic target in HFpEF and PH and combined pre- and postcapillary PH (Cpc-PH).
METHODS


We enrolled 50 patients with HFpEF and Cpc-PH who were determined by echocardiography to have pulmonary artery systolic pressure (PASP) > 40 mmHg, pulmonary vascular resistance > 3 Wood units, and/or transpulmonary gradient > 15 mmHg.
RESULTS


The patients were assigned to the phosphodiesterase 5 (PDE5) inhibitor sildenafil group (25 mg TID for 3 months followed by 50 mg TID for 3 months; n = 30) or the control group (n = 20). In the sildenafil group after 6 months, the 6-min walk distance increased by 50 m (95% CI, 36 to 64 m); substantial improvement in NYHA functional class and exercise capacity during diastolic stress test were revealed; decreases in early mitral inflow to mitral annulus relaxation velocities ratio by 2.4 (95% CI, - 3.3 to - 1.4) and PASP by 17.0 mmHg (95% CI, 20.4 to 13.5) were observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion) increased by 0.42 cm (95% CI, 0.32 to 0.52 cm; P < 0.01 for all). No changes occurred in the control group.
CONCLUSIONS


In a subset of patients with HFpEF and Cpc-PH assessed by echocardiography, PDE5 inhibition was associated with an improvement in exercise capacity, pulmonary haemodynamic parameters, and right ventricular function. The role of sildenafil needs to be considered in randomized trials in selected patients with HFpEF with invasively confirmed Cpc-PH.
TRIAL REGISTRATION


Russian National Information System of Research, Development and Technology Data of Civilian Usage (NIS, https://rosrid.ru), registration number 01201257849 . Registered 20 April 2012. This manuscript adheres to the CONSORT guidelines.",2020,"In the sildenafil group after 6 months, the 6-min walk distance increased by 50 m (95% CI, 36 to 64 m); substantial improvement in NYHA functional class and exercise capacity during diastolic stress test were revealed; decreases in early mitral inflow to mitral annulus relaxation velocities ratio by 2.4 (95% CI, - 3.3 to - 1.4) and PASP by 17.0 mmHg (95% CI, 20.4 to 13.5) were observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion) increased by 0.42 cm (95% CI, 0.32 to 0.52 cm; P < 0.01 for all).","['selected patients with HFpEF with invasively confirmed Cpc-PH', 'patients with heart failure with preserved ejection fraction and combined pre- and postcapillary pulmonary hypertension', '40', '50 patients with HFpEF and Cpc-PH who were determined by echocardiography to have pulmonary artery systolic pressure (PASP) ']","['preserved ejection fraction (HFpEF', 'sildenafil', 'phosphodiesterase 5 (PDE5) inhibitor sildenafil', 'Phosphodiesterase 5 inhibitor sildenafil']","['mmHg, pulmonary vascular resistance', 'exercise capacity, pulmonary haemodynamic parameters, and right ventricular function', 'observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion', 'PASP', 'NYHA functional class and exercise capacity during diastolic stress test', 'early mitral inflow to mitral annulus relaxation velocities ratio', '6-min walk distance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1283386', 'cui_str': 'Postcapillary pulmonary hypertension'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase 5'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1318700', 'cui_str': 'Phosphodiesterase 5 inhibitor'}]","[{'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0080311', 'cui_str': 'Right ventricular function'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3888926', 'cui_str': 'Tricuspid annular plane systolic excursion'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",50.0,0.121354,"In the sildenafil group after 6 months, the 6-min walk distance increased by 50 m (95% CI, 36 to 64 m); substantial improvement in NYHA functional class and exercise capacity during diastolic stress test were revealed; decreases in early mitral inflow to mitral annulus relaxation velocities ratio by 2.4 (95% CI, - 3.3 to - 1.4) and PASP by 17.0 mmHg (95% CI, 20.4 to 13.5) were observed; right ventricular systolic function (M-mode tricuspid annular plane systolic excursion) increased by 0.42 cm (95% CI, 0.32 to 0.52 cm; P < 0.01 for all).","[{'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Belyavskiy', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany. evgeny.belyavskiy@charite.de.'}, {'ForeName': 'Artem', 'Initials': 'A', 'LastName': 'Ovchinnikov', 'Affiliation': 'Out-Patient Department, Institute of Clinical Cardiology, National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Potekhina', 'Affiliation': 'Out-Patient Department, Institute of Clinical Cardiology, National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Fail', 'Initials': 'F', 'LastName': 'Ageev', 'Affiliation': 'Out-Patient Department, Institute of Clinical Cardiology, National Medical Research Center of Cardiology of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Edelmann', 'Affiliation': 'Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow - Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01671-2']
2625,32912184,Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial.,"BACKGROUND


Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy.
METHODS


Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13-32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson's Chi-square test or Fisher's exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software.
DISCUSSION


promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved -'10,000-11,000 steps a day'- should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03735381 . Registered 8th November, 2018.",2020,"At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected.","['pregnant women', 'healthy sedentary pregnant women (n\u2009=\u2009265), Walking_Preg Project (WPP), from university hospital in Granada, Spain']","['Walking_Preg project (WPP', 'intervention group I2 (pedometer, no goal) and control (no pedometer', 'walking program']","['sleep quality and quality of life', 'frequency of insomnia/quality of life', 'hours of sleep and quality of sleep', 'life quality', 'Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0086190', 'cui_str': 'Drugs, Illegal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]",,0.119603,"At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Amezcua-Prieto', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, Tower A, 8th Floor, Room 06, 18016, Granada, Spain. carmezcua@ugr.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Naveiro-Fuentes', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen de las Nieves University Hospital, 8014, Granada, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Arco-Jiménez', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, Tower A, 8th Floor, Room 06, 18016, Granada, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Olmedo-Requena', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, Tower A, 8th Floor, Room 06, 18016, Granada, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Barrios-Rodríguez', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, Tower A, 8th Floor, Room 06, 18016, Granada, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vico-Zúñiga', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen de las Nieves University Hospital, 8014, Granada, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Manzanares Galán', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen de las Nieves University Hospital, 8014, Granada, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mozas-Moreno', 'Affiliation': 'Instituto de Investigación Biosanitaria ibs. GRANADA, Granada, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Jiménez-Moleón', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, University of Granada, Tower A, 8th Floor, Room 06, 18016, Granada, Spain.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Gallo-Vallejo', 'Affiliation': 'Obstetrics and Gynecology Service, Virgen de las Nieves University Hospital, 8014, Granada, Spain.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03225-y']
2626,32912192,Antibiotic prescribing and non-prescribing in nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA): study protocol for a cluster randomized controlled trial.,"BACKGROUND


Antibiotic overprescribing for suspected urinary tract infection (UTI) in nursing homes (NHs) is common. Typical clinical scenarios in which antibiotics are inappropriately prescribed include response to nonspecific signs and symptoms and/or a positive urine test in the absence of symptoms referable to the urinary tract. These and other scenarios for inappropriate antibiotic prescribing were addressed in a recent international Delphi study which resulted in the development of a decision tool for the empiric treatment of UTI in frail older adults. The aim of the current study is to implement this decision tool, by integrating it into the electronic health record (EHR) and providing education on its content and use, and to evaluate its effect on appropriate antibiotic prescribing. An additional aim is to evaluate the quality of the intervention and the implementation process.
METHODS


A cluster Randomized Controlled Trial (cRCT) is conducted in sixteen NHs and aims to include 897 residents diagnosed with suspected UTI. NHs in the intervention group use the EHR-integrated decision tool, and receive education for physicians and nursing staff; in the control group care as usual is provided. Data is collected through case report forms within the EHR at the day of diagnosis and at 3, 7, and 21 days thereafter. The primary outcome is appropriate antibiotic prescribing for suspected UTI at the day of diagnosis. Secondary outcomes include the course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality. Data on total antibiotic prescribing are additionally collected in the participating NHs 12 months before and during the study. Finally, the process evaluation combines cRCT data with questionnaires and qualitative interviews with NH professionals.
DISCUSSION


This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents. Study findings will elucidate the effect of the intervention on appropriate antibiotic prescribing for suspected UTI, and provide insight into the applicability of the decision tool in NHs in general and in specific subgroups of NH residents. With this study we aim to contribute to antibiotic stewardship efforts in long-term care.
TRIAL REGISTRATION


The ANNA study was registered at the Netherlands Trial Register on 26 February 2019, with identification number NTR NL7555 .",2020,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","['897 residents diagnosed with suspected UTI', '26 February 2019, with identification number NTR NL7555 ', 'frail older adults', 'nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA']",['Antibiotic prescribing and non-prescribing'],"['total antibiotic prescribing', 'appropriate antibiotic prescribing for suspected UTI at the day of diagnosis', 'course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0993058,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","[{'ForeName': 'Jeanine J S', 'Initials': 'JJS', 'LastName': 'Rutten', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands. L.vanbuul@amsterdamumc.nl.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases division, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community care, Radboud Institute for Health Sciences, Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Natsch', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'Department of Family Medicine, School of Medicine, and the Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Veenhuizen', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}]",BMC geriatrics,['10.1186/s12877-020-01662-0']
2627,32912311,Effects of acute hypobaric hypoxia on thermoregulatory and circulatory responses during cold air exposure.,"BACKGROUND


The thermoregulatory responses during simultaneous exposure to hypoxia and cold are not well understood owing to the opposite reactions of vasomotor tone in these two environments. Therefore, the purpose of this study was to investigate the influences of hypobaric hypoxia on various thermoregulatory responses, including skin blood flow (SkBF) during cold exposure.
METHODS


Ten subjects participated in two experimental conditions: normobaric normoxia with cold (NC, barometric pressure (P B ) = 760 mmHg) and hypobaric hypoxia with cold (HC, P B  = 493 mmHg). The air temperature was maintained at 28 °C for 65 min and gradually decreased to 19 °C for both conditions. The total duration of the experiment was 135 min.
RESULTS


The saturation of percutaneous oxygen (SpO 2 ) was maintained at 98-99% in NC condition, but decreased to around 84% in HC condition. The rectal and mean skin temperatures showed no significant differences between the conditions; however, the forehead temperature was higher in HC condition than in NC condition. The pulse rate increased in HC condition, and there was a strong negative relationship between SpO 2  and pulse rate (r = - 0.860, p = 0.013). SkBF and blood pressure showed no significant differences between the two conditions.
CONCLUSION


These results suggest that hypobaric hypoxia during cold exposure did not alter the overall thermoregulatory responses. However, hypobaric hypoxia did affect pulse rate regardless of cold exposure.",2020,"The rectal and mean skin temperatures showed no significant differences between the conditions; however, the forehead temperature was higher in HC condition than in NC condition.","['cold air exposure', 'Ten subjects participated in two experimental conditions']","['normobaric normoxia with cold (NC, barometric pressure (P B ) = 760 mmHg) and hypobaric hypoxia with cold (HC, P B  = 493 mmHg', 'acute hypobaric hypoxia']","['pulse rate increased in HC condition', 'overall thermoregulatory responses', 'forehead temperature', 'air temperature', 'rectal and mean skin temperatures', 'thermoregulatory and circulatory responses', 'saturation of percutaneous oxygen (SpO 2 ', 'SkBF and blood pressure', 'skin blood flow (SkBF']","[{'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0237510', 'cui_str': 'Barometric pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C4552489', 'cui_str': 'Hypobaric hypoxia'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1532121', 'cui_str': 'Forehead temperature'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",10.0,0.0196911,"The rectal and mean skin temperatures showed no significant differences between the conditions; however, the forehead temperature was higher in HC condition than in NC condition.","[{'ForeName': 'Sora', 'Initials': 'S', 'LastName': 'Shin', 'Affiliation': 'Graduate School of Design, Kyushu University, 4-9-1 Shiobaru, Minami-ku, Fukuoka, 815-8540, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Yasukochi', 'Affiliation': 'Department of Human Functional Genomics, Advanced Science Research Promotion Center, Mie University, 1577 Kurima-machiya, Tsu, Mie, 514-8507, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Wakabayashi', 'Affiliation': 'Faculty of Engineering, Hokkaido University, N13 W8, Kita-ku, Sapporo, Hokkaido, 060-8628, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Maeda', 'Affiliation': 'Department of Human Science, Faculty of Design, Kyushu University, 4-9-1 Shiobaru, Minami-ku, Fukuoka, 815-8540, Japan. maeda@design.kyushu-u.ac.jp.'}]",Journal of physiological anthropology,['10.1186/s40101-020-00237-7']
2628,32912323,Comparing effects of two higher intensity feedback interventions with simple feedback on improving staff communication in nursing homes-the INFORM cluster-randomized controlled trial.,"BACKGROUND


Effective communication among interdisciplinary healthcare teams is essential for quality healthcare, especially in nursing homes (NHs). Care aides provide most direct care in NHs, yet are rarely included in formal communications about resident care (e.g., change of shift reports, family conferences). Audit and feedback is a potentially effective improvement intervention. This study compares the effect of simple and two higher intensity levels of feedback based on goal-setting theory on improving formal staff communication in NHs.
METHODS


This pragmatic three-arm parallel cluster-randomized controlled trial included NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia. Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible. At baseline, 4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs. NHs were randomly allocated to a simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2 (23 homes, 72 care units). Our primary outcome was the amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool and presented as adjusted mean differences [95% confidence interval] between study arms at 12-month follow-up.
RESULTS


Baseline and follow-up data were available for 20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group. Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035). We found no difference in this outcome between the two higher intensity groups.
CONCLUSIONS


Theoretically informed feedback was superior to simple feedback in improving care aides' involvement in formal communications about resident care. This underlines that prior estimates for efficacy of audit and feedback may be constrained by the type of feedback intervention tested.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT02695836 ), registered on March 1, 2016.",2020,"Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035).","['nursing homes', '20 homes (57 care units, 751 care aides, 2428 residents) in the control group, 19 homes (61 care units, 836 care aides, 2387 residents) in the basic group, and 14 homes (45 care units, 615 care aides, 1584 residents) in the enhanced group', '23 homes, 72 care units', 'NHs participating in TREC (translating research in elder care) across the Canadian provinces of Alberta and British Columbia', 'NHs', 'Facilities with at least one care unit with 10 or more care aide responses on the TREC baseline survey were eligible', '4641 care aides and 1693 nurses cared for 8766 residents in 67 eligible NHs']","['simple (control) group (22 homes, 60 care units) or one of two higher intensity feedback intervention groups (based on goal-setting theory): basic assisted feedback (22 homes, 69 care units) and enhanced assisted feedback 2', 'two higher intensity feedback interventions with simple feedback']","['amount of formal communication about resident care that involved care aides, measured by the Alberta Context Tool']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5192273', 'cui_str': '615'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",,0.100811,"Compared to simple feedback, care aide involvement in formal communications at follow-up was 0.17 points higher in both the basic ([0.03; 0.32], p = 0.021) and enhanced groups ([0.01; 0.33], p = 0.035).","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hoben', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada. mhoben@ualberta.ca.'}, {'ForeName': 'Liane R', 'Initials': 'LR', 'LastName': 'Ginsburg', 'Affiliation': 'School of Health Policy & Management, Faculty of Health, York University, Toronto, Ontario, M3J 1P3, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Easterbrook', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Norton', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4\u2009N1, Canada.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': 'School of Nursing, University of North Carolina, Chapel Hill, NC, 27599-7460, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Andersen', 'Affiliation': 'School of Nursing, Thompson Rivers University, Kamloops, British Columbia, V2C 0C8, Canada.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Boström', 'Affiliation': 'Division of Nursing, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Huddinge, SE-104 35, Stockholm, Sweden.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cranley', 'Affiliation': 'Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, M5T 1P8, Canada.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Lanham', 'Affiliation': 'University of Texas Health Science Center San Antonio, University of Texas, San Antonio, TX, 78229, USA.'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Weeks', 'Affiliation': 'School of Nursing, Faculty of Health, Dalhousie University, Halifax, Nova Scotia, B3H 4R2, Canada.'}, {'ForeName': 'Greta G', 'Initials': 'GG', 'LastName': 'Cummings', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}, {'ForeName': 'Jayna M', 'Initials': 'JM', 'LastName': 'Holroyd-Leduc', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, Alberta, T2N 4\u2009N1, Canada.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Squires', 'Affiliation': 'School of Nursing, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, K1H 8\u2009M5, Canada.'}, {'ForeName': 'Adrian S', 'Initials': 'AS', 'LastName': 'Wagg', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, T6G 2P4, Canada.'}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Estabrooks', 'Affiliation': 'Faculty of Nursing, University of Alberta, 11405 87 Avenue, Edmonton, Alberta, T6G 1C9, Canada.'}]",Implementation science : IS,['10.1186/s13012-020-01038-3']
2629,32912351,Imagery-enhanced  v.  verbally-based group cognitive behavior therapy for social anxiety disorder: a randomized clinical trial.,"BACKGROUND


Cognitive behavior therapy (CBT) is effective for most patients with a social anxiety disorder (SAD) but a substantial proportion fails to remit. Experimental and clinical research suggests that enhancing CBT using imagery-based techniques could improve outcomes. It was hypothesized that imagery-enhanced CBT (IE-CBT) would be superior to verbally-based CBT (VB-CBT) on pre-registered outcomes.
METHODS


A randomized controlled trial of IE-CBT v. VB-CBT for social anxiety was completed in a community mental health clinic setting. Participants were randomized to IE (n = 53) or VB (n = 54) CBT, with 1-month (primary end point) and 6-month follow-up assessments. Participants completed 12, 2-hour, weekly sessions of IE-CBT or VB-CBT plus 1-month follow-up.
RESULTS


Intention to treat analyses showed very large within-treatment effect sizes on the social interaction anxiety at all time points (ds = 2.09-2.62), with no between-treatment differences on this outcome or clinician-rated severity [1-month OR = 1.45 (0.45, 4.62), p = 0.53; 6-month OR = 1.31 (0.42, 4.08), p = 0.65], SAD remission (1-month: IE = 61.04%, VB = 55.09%, p = 0.59); 6-month: IE = 58.73%, VB = 61.89%, p = 0.77), or secondary outcomes. Three adverse events were noted (substance abuse, n = 1 in IE-CBT; temporary increase in suicide risk, n = 1 in each condition, with one being withdrawn at 1-month follow-up).
CONCLUSIONS


Group IE-CBT and VB-CBT were safe and there were no significant differences in outcomes. Both treatments were associated with very large within-group effect sizes and the majority of patients remitted following treatment.",2020,"RESULTS


Intention to treat analyses showed very large within-treatment effect sizes on the social interaction anxiety at all time points (ds = 2.09-2.62), with no between-treatment differences on this outcome or clinician-rated severity [1-month OR = 1.45 (0.45, 4.62), p = 0.53; 6-month OR = 1.31 (0.42, 4.08), p = 0.65], SAD remission (1-month: IE = 61.04%, VB = 55.09%, p = 0.59); 6-month: IE = 58.73%, VB = 61.89%, p = 0.77), or secondary outcomes.","['social anxiety was completed in a community mental health clinic setting', 'Participants were randomized to IE (n = 53) or VB (n = 54', 'social anxiety disorder', 'patients with a social anxiety disorder (SAD']","['IE-CBT v. VB-CBT', 'Imagery-enhanced  v.  verbally-based group cognitive behavior therapy', 'Cognitive behavior therapy (CBT']","['SAD remission', 'social interaction anxiety', 'suicide risk', 'adverse events']","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0563664', 'cui_str': 'At risk for suicide'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",54.0,0.0609588,"RESULTS


Intention to treat analyses showed very large within-treatment effect sizes on the social interaction anxiety at all time points (ds = 2.09-2.62), with no between-treatment differences on this outcome or clinician-rated severity [1-month OR = 1.45 (0.45, 4.62), p = 0.53; 6-month OR = 1.31 (0.42, 4.08), p = 0.65], SAD remission (1-month: IE = 61.04%, VB = 55.09%, p = 0.59); 6-month: IE = 58.73%, VB = 61.89%, p = 0.77), or secondary outcomes.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'McEvoy', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Hyett', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Bank', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Erceg-Hurn', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Johnson', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kyron', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Saulsman', 'Affiliation': 'School of Psychological Science, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Moulds', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Department of Psychology, Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'Ottmar V', 'Initials': 'OV', 'LastName': 'Lipp', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Bruce N C', 'Initials': 'BNC', 'LastName': 'Campbell', 'Affiliation': 'Centre for Clinical Interventions, Perth, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}]",Psychological medicine,['10.1017/S0033291720003001']
2630,32909259,"Lifestyle Risk Factors and Cognitive Outcomes from the Multidomain Dementia Risk Reduction Randomized Controlled Trial, Body Brain Life for Cognitive Decline (BBL-CD).","BACKGROUND/OBJECTIVES


To evaluate the efficacy of a multidomain intervention to reduce lifestyle risk factors for Alzheimer's disease (AD) and improve cognition in individuals with subjective cognitive decline (SCD) or mild cognitive impairment (MCI).
DESIGN


The study was an 8-week two-arm single-blind proof-of-concept randomized controlled trial.
SETTING


Community-dwelling individuals living in Canberra, Australia, and surrounding areas.
PARTICIPANTS


Participants were 119 individuals (intervention n = 57; control n = 62) experiencing SCD or MCI.
INTERVENTION


The control condition involved four educational modules covering dementia and lifestyle risk factors, Mediterranean diet, physical activity, and cognitive engagement. Participants were instructed to implement this information into their own lifestyle. The intervention condition included the same educational modules and additional active components to assist with the implementation of this information into participants' lifestyles: dietitian sessions, an exercise physiologist session, and online brain training.
MEASUREMENTS


Lifestyle risk factors for AD were assessed using the Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI), and cognition was assessed using Alzheimer's Disease Assessment Scale-Cognitive subscale, Pfeffer Functional Activities Questionnaire, Symbol Digit Modalities Test (SDMT), Trail Making Test-B, and Category Fluency.
RESULTS


The primary analysis showed that the intervention group had a significantly lower ANU-ADRI score (χ 2  = 10.84; df = 3; P = .013) and a significantly higher cognition score (χ 2  = 7.28; df = 2; P = .026) than the control group. A secondary analysis demonstrated that the changes in lifestyle were driven by increases in protective lifestyle factors (χ 2  = 12.02; df = 3; P = .007), rather than a reduction in risk factors (χ 2  = 2.93; df = 3; P = .403), and cognitive changes were only apparent for the SDMT (χ 2  = 6.46; df = 2; P = .040). Results were robust to intention-to-treat analysis controlling for missing data.
CONCLUSION


Results support the hypothesis that improvements in lifestyle risk factors for dementia can lead to improvements in cognition over a short time frame with a population experiencing cognitive decline. Outcomes from this trial support the conduct of a larger and longer trial with this participant group.",2020,The primary analysis showed that the intervention group had a significantly lower ANU-ADRI score (χ 2  = 10.84; df = 3; P = .013) and a significantly higher cognition score (χ 2  = 7.28; df = 2; P = .026) than the control group.,"[""Alzheimer's disease (AD"", 'Community-dwelling individuals living in Canberra, Australia, and surrounding areas', 'individuals with subjective cognitive decline (SCD) or mild cognitive impairment (MCI', 'Participants were 119 individuals (intervention n = 57; control n = 62) experiencing SCD or MCI']","[""same educational modules and additional active components to assist with the implementation of this information into participants' lifestyles: dietitian sessions, an exercise physiologist session, and online brain training"", 'multidomain intervention']","['protective lifestyle factors', ""Australian National University-Alzheimer's Disease Risk Index (ANU-ADRI), and cognition was assessed using Alzheimer's Disease Assessment Scale-Cognitive subscale, Pfeffer Functional Activities Questionnaire, Symbol Digit Modalities Test (SDMT), Trail Making Test-B, and Category Fluency"", 'risk factors', 'cognitive changes', 'ANU-ADRI score', 'cognition score']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",119.0,0.0472102,The primary analysis showed that the intervention group had a significantly lower ANU-ADRI score (χ 2  = 10.84; df = 3; P = .013) and a significantly higher cognition score (χ 2  = 7.28; df = 2; P = .026) than the control group.,"[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'McMaster', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing (CRAHW), The Australian National University, Canberra, Australia.'}, {'ForeName': 'Sarang', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Wicking Dementia Research and Education Centre, University of Tasmania, Hobart, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health (REACH), University of Exeter, Exeter, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Torres', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute for Physical Activity and Nutrition, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Cherbuin', 'Affiliation': 'Centre for Research on Ageing, Health and Wellbeing (CRAHW), The Australian National University, Canberra, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'DʼEste', 'Affiliation': 'National Centre for Epidemiology and Population Health (NCEPH), The Australian National University, Canberra, Australia.'}, {'ForeName': 'Kaarin J', 'Initials': 'KJ', 'LastName': 'Anstey', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Sydney, Australia.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16762']
2631,32909274,Is gene panel more efficient than clinical based gene sequencing to diagnose autoinflammatory diseases? A randomized study.,"OBJECTIVE


The aim of this study was to compare the effectiveness of the gene-panel next-generation sequencing (NGS) strategy versus the clinical based gene Sanger sequencing for the genetic diagnosis of autoinflammatory diseases (AIDs). Secondary goals were to describe the gene and mutation distribution in AID patients and to evaluate the impact of the genetic report on the patient's medical care and treatment.
METHODS


Patients with AID symptoms were enrolled prospectively and randomized to 2 arms, NGS (n=99) (32 to 55 genes) and Sanger sequencing (n=197) (1 to 4 genes). Genotypes were classified as ""consistent/confirmatory"", ""uncertain significance"" or ""non-contributory"".
RESULTS


The proportion of patients with pathogenic genotypes concordant with the AID phenotype (consistent/confirmatory) was significantly higher with NGS than Sanger sequencing (10/99 [10.1%] vs 8/197 [4.1%]). MEFV, ADA2 and MVK were the most represented genes with a consistent/confirmed genotype, whereas MEFV, NLRP3, NOD2 and TNFRSF1A were found in the ""uncertain significance"" genotypes. Six months after the genetic report was sent, 54/128 (42.2%) patients had received effective treatment for their symptoms; 13/128 (10.2%) had started treatment after the genetic study. For 59/128 (46%) patients, the results had an impact on their overall care, independent of sequencing group and diagnostic conclusion.
CONCLUSION


Targeted NGS improved the diagnosis and global care of patients with AIDs.",2020,"For 59/128 (46%) patients, the results had an impact on their overall care, independent of sequencing group and diagnostic conclusion.
","['Patients with AID symptoms', 'n=99', 'patients with AIDs']","['gene-panel next-generation sequencing (NGS) strategy', 'NGS']","['MEFV, ADA2 and MVK', 'MEFV, NLRP3, NOD2 and TNFRSF1A']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3267073', 'cui_str': 'Autoinflammatory disease'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}]","[{'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}]",,0.065332,"For 59/128 (46%) patients, the results had an impact on their overall care, independent of sequencing group and diagnostic conclusion.
","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Rama', 'Affiliation': 'CHU Montpellier, Univ Montpellier, Department of Medical Genetics, Rare diseases and Personalized medicine, Rare and Autoinflammatory diseases unit, Montpellier, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Mura', 'Affiliation': 'Medical Information Department, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Kone-Paut', 'Affiliation': 'Department of Paediatric Rheumatology, CEREMAIA, Bicêtre Hospital, AP-HP, University of Paris Sud Saclay, AP-HP, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Guilaine', 'Initials': 'G', 'LastName': 'Boursier', 'Affiliation': 'CHU Montpellier, Univ Montpellier, Department of Medical Genetics, Rare diseases and Personalized medicine, Rare and Autoinflammatory diseases unit, Montpellier, France.'}, {'ForeName': 'Safa', 'Initials': 'S', 'LastName': 'Aouinti', 'Affiliation': 'Medical Information Department, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Touitou', 'Affiliation': 'CHU Montpellier, Univ Montpellier, Department of Medical Genetics, Rare diseases and Personalized medicine, Rare and Autoinflammatory diseases unit, Montpellier, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Sarrabay', 'Affiliation': 'CHU Montpellier, Univ Montpellier, Department of Medical Genetics, Rare diseases and Personalized medicine, Rare and Autoinflammatory diseases unit, Montpellier, France.'}]",Clinical and experimental immunology,['10.1111/cei.13511']
2632,32909365,"Randomized double-blind clinical trial examining the Ellagic acid effects on glycemic status, insulin resistance, antioxidant, and inflammatory factors in patients with type 2 diabetes.","Oxidative stress can worsen glycemic status. Considering the antioxidant properties of Ellagic acid (EA), this study was designed to evaluate the effect of EA on glycemic indices, lipid profile, oxidative stress, and inflammation status in type 2 diabetic patients. Overall, 44 patients were recruited and were randomly allocated consumed 180 mg of EA per day (n = 22) or placebo (n = 22) for 8 weeks. The blood sugar (BS), insulin, insulin resistance (IR), hemoglobin A1c (HbA 1  c), total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), total antioxidant capacity (TAC), malondialdehyde (MDA), the activity of glutathione peroxidase (GPx) and superoxide dismutase (SOD), C-reactive protein (CRP), TNF-α and interleukin 6 (IL-6) were measured at the beginning and end of the study. At the end of the study, the mean of BS, insulin, IR, HbA 1  c, TC, TG, LDL, MDA, CRP, TNF-α, and IL-6 were significantly decreased in the intervention group (p < .05). Also, the mean of TAC (+0.8 ± 0.01) and activity of GPx (+10.26 ± 0.22) and SOD enzymes (+459.6 ± 9.76) significantly increased in the intervention group (p < .05). EA supplementation can be helpful as a diet supplement in patients with type 2 diabetes through improvement in chronic adverse effects.",2020,"At the end of the study, the mean of BS, insulin, IR, HbA 1  c, TC, TG, LDL, MDA, CRP, TNF-α, and IL-6 were significantly decreased in the intervention group (p < .05).","['type 2 diabetic patients', 'patients with type 2 diabetes', '44 patients']","['Ellagic acid (EA', 'placebo', 'EA', 'EA supplementation']","['mean of BS, insulin, IR, HbA 1  c, TC, TG, LDL, MDA, CRP, TNF-α, and IL-6', 'mean of TAC', 'activity of GPx', 'SOD enzymes', 'glycemic indices, lipid profile, oxidative stress, and inflammation status', 'blood sugar (BS), insulin, insulin resistance (IR), hemoglobin A1c (HbA 1  c), total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), total antioxidant capacity (TAC), malondialdehyde (MDA), the activity of glutathione peroxidase (GPx) and superoxide dismutase (SOD), C-reactive protein (CRP), TNF-α and interleukin 6 (IL-6', 'glycemic status, insulin resistance, antioxidant, and inflammatory factors']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013900', 'cui_str': 'Ellagic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}]",44.0,0.226853,"At the end of the study, the mean of BS, insulin, IR, HbA 1  c, TC, TG, LDL, MDA, CRP, TNF-α, and IL-6 were significantly decreased in the intervention group (p < .05).","[{'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of Nutrition, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Foroughi', 'Affiliation': 'Department of Immunology, School of Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Hashemipour', 'Affiliation': 'Metabolic Diseases Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Rashidi Nooshabadi', 'Affiliation': 'Department of Pharmacology, School of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Laboratory Sciences, School of Allied Medical Sciences, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Ahadi Nezhad', 'Affiliation': 'Social Determinants of Health Research Center, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khadem Haghighian', 'Affiliation': 'Department of Nutrition, School of Health, Qazvin University of Medical Sciences, Qazvin, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6867']
2633,32909387,Economic evaluation of facility-based HIV self-testing among adult outpatients in Malawi.,"INTRODUCTION


HIV self-testing (HIVST) in outpatient departments (OPD) is a promising strategy for HIV testing in Malawi, given high OPD patient volumes and substantial wait times. To evaluate the relative cost and expected impact of facility-based HIVST (FB-HIVST) at OPDs in Malawi for increasing HIV status awareness, we conducted an economic evaluation of an HIVST cluster-randomized controlled trial.
METHODS


A cluster-randomized trial was conducted at 15 sites in Malawi from September 2017 to February 2018 with three arms: 1) Standard provider-initiated-testing-and-counselling (PITC); 2) Optimized PITC (additional provider training and job-aids) and 3) FB-HIVST (HIVST demonstration, distribution and kit use in OPD, private kit interpretation and optional HIV counselling). The total production cost per newly identified positive and per person newly initiated on ART were calculated by study arm. These were calculated as the total cost of testing everyone divided by the number of newly identified positives; and the total cost of testing everyone divided by the number of those initiated on ART. Cost-outcomes were calculated under three cost scenarios: (1) full study costs, (2) routine implementation costs and (3) routine implementation + reduced cost for HIVST kits.
RESULTS


The average cost per person newly diagnosed in the full study cost scenario was $101, $156 and $189, and cost per person initiated on ART was $121, $156 and $279 for Standard PITC, Optimized PITC and FB-HIVST respectively. In the routine implementation cost scenario, the average cost per person newly diagnosed was reduced to $83, and $93, and cost per person initiated on ART to $83, and $137 for Optimized PITC and FB-HIVST respectively. In the negotiated HIVST cost scenario, the average cost per person newly diagnosed was reduced to $55 and cost per person newly initiated on ART reduced to $81 in the FB-HIVST arm.
CONCLUSIONS


While the cost per new ART initiation through FB-HIVST was higher than Standard PITC, FB-HIVST could become cost-saving compared to PITC if the cost of kits is reduced or if treatment linkage rate were increased in the FB-HIVST arm. For high volume OPDs, HIVST may increase facility capacity and increase the number of newly diagnosed positives.",2020,"To evaluate the relative cost and expected impact of facility-based HIVST (FB-HIVST) at OPDs in Malawi for increasing HIV status awareness, we conducted an economic evaluation of an HIVST cluster-randomized controlled trial.
","['outpatient departments (OPD', 'A cluster-randomized trial was conducted at 15 sites in Malawi from September 2017 to February 2018 with three arms: 1', 'adult outpatients in Malawi']","['HIV self-testing (HIVST', 'facility-based HIV self-testing', 'Standard provider-initiated-testing-and-counselling (PITC); 2) Optimized PITC (additional provider training and job-aids) and 3) FB-HIVST (HIVST demonstration, distribution and kit use in OPD, private kit interpretation and optional HIV counselling', 'facility-based HIVST (FB-HIVST']","['linkage rate', 'Cost-outcomes', 'total production cost', 'facility capacity']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0509478,"To evaluate the relative cost and expected impact of facility-based HIVST (FB-HIVST) at OPDs in Malawi for increasing HIV status awareness, we conducted an economic evaluation of an HIVST cluster-randomized controlled trial.
","[{'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Nichols', 'Affiliation': 'Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'O Agatha', 'Initials': 'OA', 'LastName': 'Offorjebe', 'Affiliation': 'David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Refiloe', 'Initials': 'R', 'LastName': 'Cele', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Frackson', 'Initials': 'F', 'LastName': 'Shaba', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Balakasi', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Chivwara', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'Long', 'Affiliation': 'Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dovel', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}]",Journal of the International AIDS Society,['10.1002/jia2.25612']
2634,32909439,Does the Presence of Neuropathic Pain Influence the Response to Hyaluronic Acid in Patients with Knee Osteoarthritis?,"OBJECTIVES


Up to 50% of patients with symptomatic knee osteoarthritis (OA) present with neuropathic pain (NP) features. We assessed the impact of NP according to DN4 (Douleurs Neuropathiques 4 questions) score on the response to intra-articular (IA) hyaluronic acid (HA) injections and the effects of HA injections on NP.
MATERIALS AND METHODS


We conducted a  post hoc  analysis from a multicenter, randomized, double-blind, noninferiority trial comparing the efficacy of 2 HA in symptomatic knee OA at 24 weeks. At baseline, demographic, anthropometric, radiologic data, and symptoms were recorded. The symptomatic effect of HA was assessed by VAS pain, patient global assessment (PGA), WOMAC, DN4, and OMERACT-OARSI response.
RESULTS


A total of 187 patients were included. NP according to DN4 score was present in 20 patients (10.7%) at baseline. Most common positive DN4 items were tingling (36.9%) and burning (36.4%). NP was associated with WOMAC pain score ( P  = 0.02). The presence of NP at baseline did not affect the symptomatic improvement after HA injections according to the VAS pain ( P  = 0.71), PGA ( P  = 050), WOMAC pain ( P  = 0.89), WOMAC function ( P  = 0.52), and rate of OMERACT-OARSI responders ( P  = 0.21). The prevalence of patients with NP decreased by 50% ( n  = 10) at 24 weeks after HA injections. Most improved DN4 items were itching (90%), hypoesthesia to pinprick (88%), and burning (50%).
CONCLUSION


In our study, NP was associated with pain severity, but did not influence the response to IA HA. On the other hand, HA injections reduced some NP features, especially itching, sting hypoesthesia, and burning.",2020,"WOMAC pain ( P  = 0.89), WOMAC function ( P  = 0.52), and rate of OMERACT-OARSI responders ( P  = 0.21).","['A total of 187 patients were included', 'Patients with Knee Osteoarthritis', 'symptomatic knee OA at 24 weeks', 'patients with symptomatic knee osteoarthritis (OA) present with neuropathic pain (NP) features']","['Hyaluronic Acid', 'HA injections']","['demographic, anthropometric, radiologic data, and symptoms', 'rate of OMERACT-OARSI responders', 'WOMAC pain score', 'NP features, especially itching, sting hypoesthesia, and burning', 'VAS pain, patient global assessment (PGA), WOMAC, DN4, and OMERACT-OARSI response', 'WOMAC pain', 'VAS pain', 'tingling', 'WOMAC function', 'pain severity', 'hypoesthesia to pinprick']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",187.0,0.502179,"WOMAC pain ( P  = 0.89), WOMAC function ( P  = 0.52), and rate of OMERACT-OARSI responders ( P  = 0.21).","[{'ForeName': 'Evarice', 'Initials': 'E', 'LastName': 'Tiendrebeogo', 'Affiliation': 'Department of Rheumatology, AP-HP Henri Mondor Hospital, Creteil Cedex, France.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Choueiri', 'Affiliation': 'Department of Rheumatology, AP-HP Henri Mondor Hospital, Creteil Cedex, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Chevalier', 'Affiliation': 'Department of Rheumatology, AP-HP Henri Mondor Hospital, Creteil Cedex, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Conrozier', 'Affiliation': 'Department of Rheumatology, Nord Franche-Comté Hospital, Belfort, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Eymard', 'Affiliation': 'Department of Rheumatology, AP-HP Henri Mondor Hospital, Creteil Cedex, France.'}]",Cartilage,['10.1177/1947603520954509']
2635,32909467,Exercise Adherence and Effect of Self-Regulatory Behavior Change Techniques in Patients Undergoing Curative Cancer Treatment: Secondary Analysis from the Phys-Can Randomized Controlled Trial.,"INTRODUCTION


Adherence to exercise interventions in patients with cancer is often poorly described. Further, it is unclear if self-regulatory behavior change techniques (BCTs) can improve exercise adherence in cancer populations. We aimed to (1) describe exercise adherence in terms of frequency, intensity, time, type (FITT-principles) and dropouts, and (2) determine the effect of specific self-regulatory BCTs on exercise adherence in patients participating in an exercise intervention during curative cancer treatment.
METHODS


This study was a secondary analysis using data from a Swedish multicentre RCT. In a 2×2 factorial design, 577 participants recently diagnosed with curable breast, colorectal or prostate cancer were randomized to 6 months of high (HI) or low-to-moderate intensity (LMI) exercise,  with  or  without  self-regulatory BCTs (e.g., goal-setting and self-monitoring). The exercise program included supervised group-based resistance training and home-based endurance training. Exercise adherence (performed training/prescribed training) was assessed using attendance records, training logs and heart rate monitors, and is presented descriptively. Linear regression and logistic regression were used to assess the effect of self-regulatory BCTs on each FITT-principle and dropout rates, according to intention-to-treat.
RESULTS


For resistance training (groups  with  vs  without  self-regulatory BCTs), participants attended on average 52% vs 53% of prescribed sessions, performed 79% vs 76% of prescribed intensity, and 80% vs 77% of prescribed time. They adhered to exercise type in 71% vs 68% of attended sessions. For endurance training (groups  with  vs  without  self-regulatory BCTs), participants performed on average 47% vs 51% of prescribed sessions, 57% vs 62% of prescribed intensity, and 71% vs 72% of prescribed time. They adhered to exercise type in 79% vs 78% of performed sessions. Dropout rates (groups  with  vs  without  self-regulatory BCTs) were 29% vs 28%. The regression analysis revealed no effect of the self-regulatory BCTs on exercise adherence.
CONCLUSION


An exercise adherence rate ≥50% for each FITT-principle and dropout rates at ~30% can be expected among patients taking part in long-term exercise interventions, combining resistance and endurance training during curative cancer treatment. Our results indicate that self-regulatory BCTs do not improve exercise adherence in interventions that provide evidence-based support to all participants (e.g., supervised group sessions).
TRIAL REGISTRATION


NCT02473003.",2020,"The regression analysis revealed no effect of the self-regulatory BCTs on exercise adherence.
","['Patients Undergoing Curative Cancer Treatment', '577 participants recently diagnosed with curable breast, colorectal or prostate cancer', 'patients participating in an exercise intervention during curative cancer treatment', 'patients with cancer']","['resistance training', 'high (HI) or low-to-moderate intensity (LMI) exercise,  with  or  without  self-regulatory BCTs (e.g., goal-setting and self-monitoring', 'specific self-regulatory BCTs', 'endurance training (groups  with  vs  without  self-regulatory BCTs', 'Self-Regulatory Behavior Change Techniques', 'exercise program included supervised group-based resistance training and home-based endurance training']","['Dropout rates', 'exercise adherence', 'Exercise adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",577.0,0.0544387,"The regression analysis revealed no effect of the self-regulatory BCTs on exercise adherence.
","[{'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Mazzoni', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Brooke', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nordin', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Demmelmaier', 'Affiliation': 'Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.'}]",Integrative cancer therapies,['10.1177/1534735420946834']
2636,32909643,Pharmacodynamic analysis of apremilast in Japanese patients with moderate to severe psoriasis: Results from a phase 2b randomized trial.,"We evaluated the pharmacodynamic effects of apremilast in 69 patients who were included in biomarker subanalyses of a phase 2b study that demonstrated the long-term safety and efficacy of apremilast in Japanese adults with moderate to severe psoriasis. The association between cytokine levels and Psoriasis Area and Severity Index (PASI) improvement was evaluated using linear regression and Spearman's rank correlation coefficient analysis. At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal. With apremilast 30 mg b.i.d., there were significant associations between percentage change in PASI score and percentage change in IL-17A, IL-17F and IL-22 levels at week 16. Findings demonstrate that the efficacy of apremilast in psoriasis is associated with inhibition of key cytokines involved in the pathology of psoriasis.",2020,"At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal.","['Japanese adults with moderate to severe psoriasis', 'Japanese patients with moderate to severe psoriasis', '69 patients who were included in biomarker subanalyses of a phase 2b study']",[],"['median plasma levels of interleukin (IL)-17A, IL-17F and IL-22', 'pharmacodynamic effects', 'cytokine levels and Psoriasis Area and Severity Index (PASI) improvement', 'tumor necrosis factor-α levels', 'PASI score and percentage change in IL-17A, IL-17F and IL-22 levels']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",69.0,0.0590281,"At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal.","[{'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Imafuku', 'Affiliation': 'Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Nemoto', 'Affiliation': 'Kojinkai Sapporo Skin Clinic, Sapporo, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Okubo', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Komine', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schafer', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Petric', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Mamitaro', 'Initials': 'M', 'LastName': 'Ohtsuki', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15596']
2637,32909660,"A randomised, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER).","BACKGROUND


The anti-interleukin 13 (IL-13) monoclonal antibody lebrikizumab improves lung function in patients with moderate to severe uncontrolled asthma, but its effects on airway inflammation and remodelling are unknown. CLAVIER was designed to assess lebrikizumab's effect on eosinophilic inflammation and remodelling.
OBJECTIVE


To report safety and efficacy results from enrolled participants with available data from CLAVIER.
METHODS


We performed bronchoscopy on patients with uncontrolled asthma before and after 12 weeks of randomised double-blinded treatment with lebrikizumab (n=31) or placebo (n=33). The pre-specified primary endpoint was relative change in airway subepithelial eosinophils per mm 2  of basement membrane (cells/mm 2  ). Pre-specified secondary and exploratory outcomes included change in IL-13-associated biomarkers and measures of airway remodelling.
RESULTS


There was a baseline imbalance in tissue eosinophils and high variability between treatment groups. There was no discernible change in adjusted mean subepithelial eosinophils/mm 2  in response to lebrikizumab (95% CI, -82.5%, 97.5%). As previously observed, FEV 1  increased after lebrikizumab treatment. Moreover, subepithelial collagen thickness decreased 21.5% after lebrikizumab treatment (95% CI, -32.9%, -10.2%), and fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues also reduced. Lebrikizumab was well tolerated, with a safety profile consistent with other lebrikizumab asthma studies.
CONCLUSIONS & CLINICAL RELEVANCE


We did not observe reduced tissue eosinophil numbers in association with lebrikizumab treatment. However, in pre-specified exploratory analyses, lebrikizumab treatment was associated with reduced degree of subepithelial fibrosis, a feature of airway remodelling, as well as improved lung function and reduced key pharmacodynamic biomarkers in bronchial tissues. These results reinforce the importance of IL-13 in airway pathobiology and suggest that neutralisation of IL-13 may reduce asthmatic airway remodelling.",2020,"Moreover, subepithelial collagen thickness decreased 21.5% after lebrikizumab treatment (95% CI, -32.9%, -10.2%), and fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues also reduced.","['patients with moderate to severe uncontrolled asthma', 'enrolled participants with available data from CLAVIER', 'patients with uncontrolled asthma before and after 12 weeks']","['Lebrikizumab', 'placebo', 'lebrikizumab']","['relative change in airway subepithelial eosinophils', 'airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER', 'eosinophilic inflammation and remodelling', 'IL-13-associated biomarkers and measures of airway remodelling', 'lung function', 'fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues', 'subepithelial collagen thickness', 'degree of subepithelial fibrosis', 'tissue eosinophil numbers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C2981360', 'cui_str': 'lebrikizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C3687252', 'cui_str': 'Eosinophilic inflammation'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0907797', 'cui_str': 'CCL26 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0229610', 'cui_str': 'Tissue eosinophil'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.235184,"Moreover, subepithelial collagen thickness decreased 21.5% after lebrikizumab treatment (95% CI, -32.9%, -10.2%), and fractional exhaled nitric oxide, CCL26, and SERPINB2 mRNA expression in bronchial tissues also reduced.","[{'ForeName': 'Cary D', 'Initials': 'CD', 'LastName': 'Austin', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Gonzalez Edick', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Ferrando', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Solon', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Baca', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Mesh', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'University of Leicester and Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Gail M', 'Initials': 'GM', 'LastName': 'Gauvreau', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kaharu', 'Initials': 'K', 'LastName': 'Sumino', 'Affiliation': 'Washington University School of Medicine in St. Louis, St Louis, MO, United States.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, United States.""}, {'ForeName': 'Lief', 'Initials': 'L', 'LastName': 'Bjermer', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bourdin', 'Affiliation': 'CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Arron', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Choy', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Olsson', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Abreu', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Monet', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Wong', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cai', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Peng', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Putnam', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Cécile T J', 'Initials': 'CTJ', 'LastName': 'Holweg', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Matthews', 'Affiliation': 'Genentech, Inc, South San Francisco, CA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Kraft', 'Affiliation': 'University of Arizona College of Medicine, Tucson, AZ, United States.'}, {'ForeName': 'Prescott G', 'Initials': 'PG', 'LastName': 'Woodruff', 'Affiliation': 'University of California, San Francisco Medical Center, San Francisco, CA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13731']
2638,32909675,Modulation of cardiometabolic disease markers by type I interferon inhibition in systemic lupus erythematosus.,"OBJECTIVES


Neutrophil dysregulation and the type I interferon (IFN) axis have been proposed to contribute to premature cardiovascular disease, a leading cause of mortality in patients with systemic lupus erythematosus (SLE). We evaluated the ability of anifrolumab, a type I IFN receptor-blocking antibody, to reduce neutrophil extracellular trap (NET) formation and modulate cardiometabolic disease markers relative to placebo.
METHODS


Blood samples were collected pre- and post-dose from patients with moderate to severe SLE enrolled in the phase 2b MUSE trial (NCT01438489). Baseline (n=305) SLE samples were compared with healthy controls and post-treatment samples in anifrolumab 300-mg (n=99) and placebo groups (n=102). Baseline IFN gene signature test status was determined and IFN 21-gene signature was monitored over time. Serum proteins were measured by multiplex immunoassay or ultrasensitive Simoa™ technology. NET complexes, cholesterol efflux capacity (CEC), and full NMR LipoProfile ®  were assessed in plasma.
RESULTS


NET complexes, tumor necrosis factor alpha (TNF-α), and interleukin (IL)-10 correlated with type I IFN pathway activity; NET complexes and IL-10 were upregulated in patients with SLE versus healthy donors (p<0.008). Cardiometabolic disease markers CEC and GlycA were also dysregulated (p<0.001). Type I IFN receptor inhibition with anifrolumab significantly reduced NET complexes and GlycA and improved CEC from baseline (p<0.05), whereas no improvements were seen with placebo. TNF-α and IL-10 were reduced versus placebo (p<0.05).
CONCLUSION


These data support a key role for type I IFNs in modulating factors contributing to SLE vasculopathy and suggest that inhibiting this pathway could decrease cardiovascular risk in these patients.",2020,"TNF-α and IL-10 were reduced versus placebo (p<0.05).
","['systemic lupus erythematosus', 'patients with moderate to severe SLE enrolled in the phase 2b MUSE trial (NCT01438489', 'patients with systemic lupus erythematosus (SLE']",['placebo'],"['NET complexes, tumor necrosis factor alpha (TNF-α), and interleukin (IL)-10 correlated with type I IFN pathway activity; NET complexes and IL-10', 'cardiovascular risk', 'TNF-α and IL-10', 'Cardiometabolic disease markers CEC and GlycA', 'NET complexes, cholesterol efflux capacity (CEC), and full NMR LipoProfile ®', 'NET complexes and GlycA and improved CEC', 'Serum proteins']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C2366566', 'cui_str': 'Muse'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3850088', 'cui_str': 'NETs (Neutrophil Extracellular Traps)'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0318601', 'cui_str': 'Canine enteric calicivirus'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036825', 'cui_str': 'Serum protein'}]",305.0,0.18026,"TNF-α and IL-10 were reduced versus placebo (p<0.05).
","[{'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Casey', 'Affiliation': 'Respiratory, Inflammation and Autoimmunity, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Smith', 'Affiliation': 'Respiratory, Inflammation and Autoimmunity, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Sinibaldi', 'Affiliation': 'Data Science and AI, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Nickie L', 'Initials': 'NL', 'LastName': 'Seto', 'Affiliation': 'Systemic Autoimmunity Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Xinghao', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Systemic Autoimmunity Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Carlucci', 'Affiliation': 'Systemic Autoimmunity Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Liangwei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Illei', 'Affiliation': 'Clinical Development, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Binbing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Statistical Innovation, Oncology Data Science & Analytics, AstraZeneca, Gaithersburg, MD, US, United States.'}, {'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mariana J', 'Initials': 'MJ', 'LastName': 'Kaplan', 'Affiliation': 'Systemic Autoimmunity Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Wendy I', 'Initials': 'WI', 'LastName': 'White', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, AstraZeneca, Gaithersburg, MD, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41518']
2639,32910084,Internal Limiting Membrane Peeling during Vitrectomy for Diabetic Vitreous Hemorrhage: a Randomized Clinical Trial.,"PURPOSE


To evaluate the benefits of internal limiting membrane (ILM) peeling in proliferative diabetic retinopathy (PDR) subjects undergoing pars plana vitrectomy (PPV) for the treatment of vitreous hemorrhage (VH).
DESIGN


Randomized clinical trial.
METHODS


Two hundred and fifty-eight PDR subjects undergoing PPV for VH were enrolled into the trial. Patients were randomized into one of two cohorts: Group A patients underwent ILM peeling, whereas Group B patients did not undergo ILM peeling. The main outcome was best-corrected visual acuity (BCVA) at 6 months. Secondary outcomes were optical coherence tomography (OCT) central macular thickness (CMT) at 6 months, incidence of diabetic macular edema (DME) treatment during the postoperative trial period, and incidence of epiretinal membrane (ERM) at 6 months.
RESULTS


Two hundred and seven patients were randomized and completed 6 months follow up. Group A had better BCVA at 6 months compared to Group B (p<0.01). Group A had a lower incidence of DME treatment during the postoperative trial period and a lower incidence of ERM at 6 months compared to Group B (p=0.02 and p<0.001, respectively). There was a trend towards lower CMT on OCT in Group A compared to Group B (p=0.09). There were no significant differences in baseline details or complications intraoperatively or postoperatively between cohorts.
CONCLUSIONS


This trial demonstrated better vision, fewer postoperative DME treatments, and a lower incidence of ERM at 6 months when ILM peeling was performed. ILM peeling may be considered a vital maneuver to perform in PDR subjects undergoing PPV for VH.",2020,There was a trend towards lower CMT on OCT in Group A compared to Group B (p=0.09).,"['vitreous hemorrhage (VH', 'proliferative diabetic retinopathy (PDR) subjects undergoing', 'Two hundred and seven patients', 'Diabetic Vitreous Hemorrhage', 'Two hundred and fifty-eight PDR subjects undergoing PPV for VH were enrolled into the trial', 'PDR subjects undergoing PPV for VH']","['internal limiting membrane (ILM) peeling', 'Internal Limiting Membrane Peeling during Vitrectomy', 'pars plana vitrectomy (PPV', 'ILM peeling']","['ERM', 'optical coherence tomography (OCT) central macular thickness (CMT) at 6 months, incidence of diabetic macular edema (DME) treatment during the postoperative trial period, and incidence of epiretinal membrane (ERM', 'BCVA', 'corrected visual acuity (BCVA', 'incidence of DME treatment']","[{'cui': 'C0042909', 'cui_str': 'Vitreous hemorrhage'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730283', 'cui_str': 'Vitreous hemorrhage due to diabetes mellitus'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}]","[{'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}]",258.0,0.164952,There was a trend towards lower CMT on OCT in Group A compared to Group B (p=0.09).,"[{'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'Rush', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Del Valle Penella', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reinauer', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}, {'ForeName': 'Sloan W', 'Initials': 'SW', 'LastName': 'Rush', 'Affiliation': 'Panhandle Eye Group, 7400 Fleming Ave., Amarillo, Texas 79106, USA.'}, {'ForeName': 'Pedro Gomez', 'Initials': 'PG', 'LastName': 'Bastar', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002976']
2640,32910094,Inflammation Mediates Exercise Effects on Fatigue in Patients with Breast Cancer.,"PURPOSE


The randomized controlled OptiTrain trial showed beneficial effects on fatigue after a 16-week exercise intervention in patients with breast cancer undergoing adjuvant chemotherapy. We hypothesize that exercise alters systemic inflammation and that this partially mediates the beneficial effects of exercise on fatigue.
METHODS


Two hundred and forty women scheduled for chemotherapy were randomized to 16 weeks of resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT) or usual care (UC). In the current mechanistic analyses, we included all participants with >60% attendance and a random selection of controls (RT-HIIT=30, AT-HIIT=27, UC=29). Fatigue (Piper Fatigue Scale) and ninety-two markers (e.g. IL-6, TNFα) were assessed at baseline and post-intervention. Mediation analyses were conducted to explore whether changes in inflammation markers mediated the effect of exercise on fatigue.
RESULTS


Overall, chemotherapy led to an increase in inflammation. The increase in IL-6 (pleiotropic cytokine) and CD8a (T-cell surface glycoprotein) was, however, significantly less pronounced following RT-HIIT compared to UC (-0.47 (95%CI -0.87;-0.07) and -0.28 (-0.57;0.004), respectively). Changes in IL-6 and CD8a significantly mediated the exercise effects on both general and physical fatigue by 32.0% and 27.7%, and 31.2% and 26.4%, respectively. No significant between-group differences in inflammatory markers at 16 weeks were found between AT-HIIT and UC.
CONCLUSION


This study is the first showing that supervised RT-HIIT partially counteracted the increase in inflammation during chemotherapy, i.e. IL-6 and soluble CD8a, which resulted in lower fatigue levels post-intervention. Exercise including both resistance and high-intensity aerobic training might be put forward as an effective treatment to reduce chemotherapy-induced inflammation and subsequent fatigue.",2020,"The increase in IL-6 (pleiotropic cytokine) and CD8a (T-cell surface glycoprotein) was, however, significantly less pronounced following RT-HIIT compared to UC (-0.47 (95%CI -0.87;-0.07) and -0.28 (-0.57;0.004), respectively).","['Patients with Breast Cancer', 'Two hundred and forty women scheduled for', 'patients with breast cancer undergoing adjuvant chemotherapy']","['exercise intervention', 'Exercise including both resistance and high-intensity aerobic training', 'resistance and high-intensity interval training (RT-HIIT), moderate-intensity aerobic and high-intensity interval training (AT-HIIT) or usual care (UC', 'chemotherapy']","['inflammation', 'IL-6 (pleiotropic cytokine) and CD8a (T-cell surface glycoprotein', 'IL-6 and CD8a', 'Fatigue (Piper Fatigue Scale) and ninety-two markers (e.g. IL-6, TNFα', 'general and physical fatigue', 'inflammatory markers', 'Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0025248', 'cui_str': 'Membrane Glycoprotein'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0330232', 'cui_str': 'Piper'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",240.0,0.0594814,"The increase in IL-6 (pleiotropic cytokine) and CD8a (T-cell surface glycoprotein) was, however, significantly less pronounced following RT-HIIT compared to UC (-0.47 (95%CI -0.87;-0.07) and -0.28 (-0.57;0.004), respectively).","[{'ForeName': 'Anouk E', 'Initials': 'AE', 'LastName': 'Hiensch', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mijwel', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bargiela', 'Affiliation': 'Department of Physiology, Development and Neuroscience, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Wengström', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Nursing, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, University of Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rundqvist', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002490']
2641,32910097,Development and Validation of a Highly Sensitive Liquid Chromatography/Tandem Mass Spectrometry Technique to Determine Levamisole in Plasma and Saliva.,"BACKGROUND


Levamisole is used as a steroid-sparing drug for the treatment of frequently relapsing or steroid-dependent idiopathic nephrotic syndrome (INS) in children. As part of a large multicentre randomized controlled trial with levamisole, pharmacokinetic and pharmacodynamic parameters of levamisole in children with INS were investigated, as well as the feasibility of using saliva as an alternative and patient-friendly matrix for determining levamisole concentrations. In this study, the authors presented the development and validation of a highly sensitive method for determining levamisole in plasma and saliva using liquid chromatographic tandem mass spectrometry (LC-MS/MS).
METHODS


In 100 µL samples, proteins were precipitated with 750 µL acetonitrile/methanol 420:80 (v/v) with levamisole-D5 as an internal standard. Calibration standards were prepared over a range of 0.1 ng/mL to 50 ng/mL. To determine ultrafiltration efficiency, the ultrafiltrate was obtained by centrifuging blank plasma samples over the filter. Both filtered and non-filtered samples were analyzed.
RESULTS


For plasma, accuracy and within- and between-run imprecision were between 95.0% to 100% and <14.5%, respectively, and for saliva, between 100.9% and 107.5%, and <13.3%. No significant matrix effects were observed. Samples were stable at benchtop for 24 h and -80°C, for at least 14 months (stability experiments ongoing). The ultrafiltration efficiency of unbound concentrations in plasma was lower than 85% (58.9%) but stable and, therefore, the observed concentration should be corrected.
CONCLUSIONS


Based on observations, the developed measure can determine levamisole concentrations in participant saliva samples.",2020,"RESULTS


For plasma, accuracy and within- and between-run imprecision were between 95.0% to 100% and <14.5%, respectively, and for saliva, between 100.9% and 107.5%, and <13.3%.","['children with INS', 'frequently relapsing or steroid-dependent idiopathic nephrotic syndrome (INS) in children']","['Levamisole', 'levamisole']","['ultrafiltration efficiency of unbound concentrations in plasma', 'matrix effects', 'For plasma, accuracy and within- and between-run imprecision']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1704321', 'cui_str': 'Minimal Change Nephrotic Syndrome'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}]","[{'cui': 'C0023556', 'cui_str': 'Levamisole'}]","[{'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.028035,"RESULTS


For plasma, accuracy and within- and between-run imprecision were between 95.0% to 100% and <14.5%, respectively, and for saliva, between 100.9% and 107.5%, and <13.3%.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Veltkamp', 'Affiliation': ""Amsterdam University Medical Centers, University of Amsterdam, Emma Children's Hospital, Department of Pediatric Nephrology, Amsterdam, the Netherlands.""}, {'ForeName': 'M C M', 'Initials': 'MCM', 'LastName': 'Pistorius', 'Affiliation': 'Amsterdam University Medical Centers, University of Amsterdam, Department of Pharmacy, Amsterdam, the Netherlands.'}, {'ForeName': 'A H M', 'Initials': 'AHM', 'LastName': 'Bouts', 'Affiliation': ""Amsterdam University Medical Centers, University of Amsterdam, Emma Children's Hospital, Department of Pediatric Nephrology, Amsterdam, the Netherlands.""}, {'ForeName': 'R A A', 'Initials': 'RAA', 'LastName': 'Mathôt', 'Affiliation': 'Amsterdam University Medical Centers, University of Amsterdam, Department of Pharmacy, Amsterdam, the Netherlands.'}]",Therapeutic drug monitoring,['10.1097/FTD.0000000000000811']
2642,32910107,Point-of-Care Ultrasound to Confirm Umbilical Line Placement: Impact of a Simulation Enhanced Curriculum on Neonatal Intensive Care Unit Provider Competency.,"INTRODUCTION


Neonatal intensive care unit (NICU) provider point-of-care ultrasound (POCUS) procedural competency for umbilical line placement confirmation has not been defined, and the necessary training to achieve competency has not been previously studied. This study's objective was to test the hypothesis that a simulation-enhanced curriculum will improve NICU providers' POCUS competency to confirm umbilical line placement.
METHODS


Neonatal intensive care unit providers without prior ultrasound experience were randomized to a curriculum with or without simulation-based training. Competency for catheter detection, tip localization, and scan interpretation on patients was determined using learning curve-cumulative summation, a specific statistical tool designed to indicate when a predefined level of performance is reached. Differences in success rates were analyzed by χ test.
RESULTS


Two thirds (22/33) of participants completed 10 scans. Three (simulation) and 1 (control) attained catheter detection competency (P = 0.28). The simulation group was more successful for catheter detection (81% vs. 69%, P = 0.04) and scan interpretation (61% vs. 48%, P = 0.04). Success did not differ by umbilical vessel location, provider role, or duration of NICU experience.
CONCLUSIONS


A simulation-enhanced POCUS curriculum improved catheter detection rate and scan interpretation, but there was no difference in procedural competency between groups on ultrasound scans performed on patients with umbilical catheters. We speculate that more than 10 scans may be needed for NICU providers to obtain POCUS competency.",2020,"The simulation group was more successful for catheter detection (81% vs. 69%, P = 0.04) and scan interpretation (61% vs. 48%, P = 0.04).","['Neonatal intensive care unit providers without prior ultrasound experience', 'patients with umbilical catheters']","['Simulation Enhanced Curriculum', 'Neonatal intensive care unit (NICU) provider point-of-care ultrasound (POCUS', 'curriculum with or without simulation-based training', 'Care Ultrasound to Confirm Umbilical Line Placement']","['scan interpretation', 'success rates', 'umbilical vessel location, provider role, or duration of NICU experience', 'catheter detection rate and scan interpretation', 'successful for catheter detection']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960094', 'cui_str': 'Umbilical catheter'}]","[{'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.0563908,"The simulation group was more successful for catheter detection (81% vs. 69%, P = 0.04) and scan interpretation (61% vs. 48%, P = 0.04).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kochan', 'Affiliation': ""From the Departments of Pediatrics (M.J.K., S.B.H., R.M.V.) and Diagnostic Radiology and Nuclear Medicine, University of Maryland School of Medicine, Baltimore, MD; Department of Pediatrics (S.J.M.), Penn State Health Children's Hospital, Hershey, PA; and Division of Neonatology (J.H.K.), Perinatal Institute, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH.""}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Suma B', 'Initials': 'SB', 'LastName': 'Hoffman', 'Affiliation': ''}, {'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Mola', 'Affiliation': ''}, {'ForeName': 'Jae H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Rose M', 'Initials': 'RM', 'LastName': 'Viscardi', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000501']
2643,32910197,Effect of Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells in Patients With Chronic Ischemic Heart Disease: A Randomized Clinical Trial.,"Importance


Cell therapy may be helpful for cardiac disease but has been fraught with poor cell retention and survival after transplantation.
Objective


To determine whether cell-laden hydrogel treatment is safe and feasible for patients with chronic ischemic heart disease (CIHD).
Design, Setting, and Participants


This randomized, double-blind clinical trial was conducted between March 1, 2016, and August 31, 2019, at a single hospital in Nanjing, China. Among 115 eligible patients with CIHD, 50 patients with left ventricular ejection fraction of 45% or less were selected to receive elective coronary artery bypass grafting (CABG) and additionally randomized to cell-plus-collagen treatment (collagen/cell group), cell treatment alone (cell group), or a control group. Sixty-five patients were excluded because of severe comorbidities or unwillingness to participate. Forty-four participants (88%) completed the study. The last patient completed 12 months of follow-up in August 2019. Analyses were prespecified and included all patients with available data.
Interventions


During CABG, patients in the collagen/cell group were treated with human umbilical cord-derived mesenchymal stromal cell (hUC-MSC)-laden collagen hydrogel intramyocardial injection, and the cell group was treated with hUC-MSCs alone. Patients in the control group underwent CABG alone.
Main Outcomes and Measures


The primary outcome was safety of the cell-laden collagen hydrogel assessed by the incidence of serious adverse events. The secondary end point was the efficacy of treatment, according to cardiovascular magnetic resonance imaging-based left ventricular ejection fraction and infarct size.
Results


Fifty patients (mean [SD] age, 62.6 [8.3] years; 38 men [76%]) were enrolled, of whom 18 were randomized to the collagen/cell group, 17 to the cell group, and 15 to the control group. Patient characteristics did not differ among groups at baseline. For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group. At 12 months after treatment, the mean infarct size percentage change was -3.1% (95% CI, -6.20% to -0.02%; P = .05) in the collagen/cell group, 5.19% (-1.85% to 12.22%, P = .35) in the cell group, and 8.59% (-3.06% to 20.25%, P = .21) in the control group.
Conclusions and Relevance


This study provides, to our knowledge, the first clinical evidence that the use of collagen hydrogel is safe and feasible for cell delivery. These findings provide a basis for larger clinical studies.
Trial Registration


ClinicalTrials.gov Identifier: NCT02635464.",2020,"For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group.","['With Chronic Ischemic Heart Disease', 'patients with chronic ischemic heart disease (CIHD', 'Sixty-five patients were excluded because of severe comorbidities or unwillingness to participate', '115 eligible patients with CIHD, 50 patients with left ventricular ejection fraction of 45% or less were selected to receive', 'Patients', 'Fifty patients (mean [SD] age, 62.6 [8.3] years; 38 men [76', 'Forty-four participants (88%) completed the study', 'March 1, 2016, and August 31, 2019, at a single hospital in Nanjing, China']","['cell-laden hydrogel treatment', 'human umbilical cord-derived mesenchymal stromal cell (hUC-MSC)-laden collagen hydrogel intramyocardial injection', 'cell-plus-collagen treatment (collagen/cell group), cell treatment alone (cell group), or a control group', 'collagen hydrogel', 'elective coronary artery bypass grafting (CABG', 'Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells', 'CABG alone', 'hUC-MSCs alone']","['efficacy of treatment, according to cardiovascular magnetic resonance imaging-based left ventricular ejection fraction and infarct size', 'safety of the cell-laden collagen hydrogel assessed by the incidence of serious adverse events', 'hospitalization because of heart failure, and no serious adverse events', 'mean infarct size percentage change', 'serious adverse events, myocardial damage markers, and renal or liver function']","[{'cui': 'C0264694', 'cui_str': 'Chronic myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}]",50.0,0.116717,"For the primary end point, no significant differences in serious adverse events, myocardial damage markers, and renal or liver function were observed among all groups after treatment; the collagen/cell and cell groups each had 1 case of hospitalization because of heart failure, and no serious adverse events were seen in the control group.","[{'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Center for Clinical Stem Cell Research, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Radiology, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Liudi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Center for Clinical Stem Cell Research, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Dai', 'Affiliation': 'Key Laboratory of Molecular Developmental Biology, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dongjin', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.16236']
2644,32910326,What is the preferred hemostasis method for coronary angiography through the palmar artery access?,"Trans-palmar catheterization has been considered to be safe and feasible and choosing a reliable hemostasis method is essential to confirm it. The aim of our study was to compare the efficacy and safety of three hemostasis approaches containing ulnar TR band, manual compression and wrist hyperextension in patients undergoing trans-palmar coronary angiography (CAG). In a non-randomized clinical trial, a total of 106 patients undergoing diagnostic CAG by tarns-palmar access were divided into three groups: ulnar TR band, manual compression and wrist hyperextension. Duration of primary hemostasis, patient satisfaction, puncture site pain severity, hospitalization time and local neuro-vascular complication were evaluated and compared in hospital and 30 days follow-up. The mean age of the patients was 62.9 ± 7.4 years and 72 patients (67.9%) were male. Primary hemostasis time was significantly shorter in hyperextension (11.5 ± 2.10 min) and manual compression groups (12.3 ± 2.20 min) than with TR band group (24.7 ± 10.25 min) (p value < 0.0001). Patient's satisfaction was higher in hyperextension approach (9.4 ± 0.65) than manual compression (8.8 ± 0.79) and TR band group (8.2 ± 0.90) (p value < 0.0001). The most pain was seen in the TR band and the less in hyperextension group until 4 h after the procedure (p value < 0.0001). Hematoma, numbness and ulnar artery occlusion as well as hospitalization time did not have significant statistical differences (p value > 0.05). In conclusion, between three methods of hemostasis in trans-palmar catheterization, hyperextension approach is the preferred method because of effectiveness, safety and less time consuming hemostatic method compared others.",2020,"Hematoma, numbness and ulnar artery occlusion as well as hospitalization time did not have significant statistical differences (p value > 0.05).","['106 patients undergoing diagnostic CAG by tarns-palmar access', 'patients undergoing trans-palmar coronary angiography (CAG', 'The mean age of the patients was 62.9\u2009±\u20097.4\xa0years and 72 patients (67.9%) were male']","['ulnar TR band, manual compression and wrist hyperextension', 'hemostasis approaches containing ulnar TR band, manual compression and wrist hyperextension']","['Hematoma, numbness and ulnar artery occlusion', ""Patient's satisfaction"", 'Duration of primary hemostasis, patient satisfaction, puncture site pain severity, hospitalization time and local neuro-vascular complication', 'efficacy and safety', 'Primary hemostasis time', 'hospitalization time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231451', 'cui_str': 'Hyperextension'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1697642', 'cui_str': 'Puncture site pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",106.0,0.0553223,"Hematoma, numbness and ulnar artery occlusion as well as hospitalization time did not have significant statistical differences (p value > 0.05).","[{'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Roghani-Dehkordi', 'Affiliation': 'Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, PO Box 815-838-8994, Isfahan, Iran.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Kasiri', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kermani-Alghoraishi', 'Affiliation': 'Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, PO Box 815-838-8994, Isfahan, Iran. sm.kermani@med.mui.ac.ir.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Akbari', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Cardiovascular intervention and therapeutics,['10.1007/s12928-020-00707-w']
2645,32910352,A Multidimensional Model of Sexual Empowerment Among Young Black Men Who have Sex with Men: A Latent Profile Analysis.,"Sexual empowerment is a key strategy in HIV prevention intervention design, yet its measurement has been conceptualized as homogeneous. To date, no studies have examined whether young Black men who have sex with men (YBMSM) exhibit heterogeneity across sexual empowerment. Using baseline data from a randomized controlled trial (N = 275, HIV-negative YBMSM), we classified YBMSM into sexual empowerment profiles based on five indicators using a latent profile analysis and assessed the associations between the sexual empowerment profiles and stigma-related experiences using multinomial logistic regression. Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3). YBMSM reporting fewer stigma-related experiences were more likely to be profile 1 than profile 2 and profile 3. To empower YBMSM, interventions based on sexual empowerment profile targeting the psychological/behavioral aspects of empowerment and addressing stigma are needed.",2020,Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3).,"['Who have Sex with Men', 'young Black men who have sex with men (YBMSM', 'Young Black Men']",['YBMSM'],[],"[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]",[],3.0,0.028098,Three profiles were identified: psychologically empowered with safer sex intentions (profile 1); psychologically disempowered with safer sex intentions (profile 2); and psychologically disempowered without safer sex intentions (profile 3).,"[{'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA. skchoi@nursing.upenn.edu.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Bauermeister', 'Affiliation': 'Department of Family and Community Health, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Room 235L, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Muessig', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ennett', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marcella H', 'Initials': 'MH', 'LastName': 'Boynton', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Department of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03031-9']
2646,32910353,Willingness to Participate in At-Home HIV Testing Among Young Adults Who Use Opioids in Rural Appalachia.,"New HIV infections associated with injection drug use are of major concern in rural US communities. This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia. Eligible participants were 18-35 years old, lived in Appalachian Kentucky, and reported using opioids to get high in the previous 30 days. A majority reported being likely (63.6%, 96/151) to take a free at-home HIV tests and 66.9% (101/151) consented to receive one. Among those who were randomly selected to receive a Home Access HIV-1 test kit (n = 37), 37.8% mailed in blood spots and 21.6% called to receive results. This study provides evidence that PWUD may be willing to take an at-home test, but other barriers may inhibit actual completion.",2020,"This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia.","['Young Adults', 'Rural Appalachia', 'Eligible participants were 18-35\xa0years old, lived in Appalachian Kentucky, and reported using opioids to get high in the previous 30\xa0days', ""people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia""]",['Home Access HIV-1 test kit'],[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}]",[],,0.0668314,"This study explores acceptability of, consent for, and uptake of free at-home HIV testing among people who use drugs (PWUD) in one of the nation's epicenters for drug-related harms and HIV vulnerability: Rural Central Appalachia.","[{'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Ballard', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY, USA. april.ballard@emory.edu.'}, {'ForeName': 'Regine', 'Initials': 'R', 'LastName': 'Haardöerfer', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Prood', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Chukwudi', 'Initials': 'C', 'LastName': 'Mbagwu', 'Affiliation': 'Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA.'}, {'ForeName': 'Hannah L F', 'Initials': 'HLF', 'LastName': 'Cooper', 'Affiliation': 'Department of Behavioral, Social, and Health Education Sciences, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Department of Epidemiology, University of Kentucky College of Public Health, Lexington, KY, USA.'}]",AIDS and behavior,['10.1007/s10461-020-03034-6']
2647,32910362,Does initial reduction at infra-orbital rim first improve malar height and vertical dystopia in ZMC fractures?,"PURPOSE


To estimate the clinical and functional results of patients who underwent distinctive types of open reduction and internal fixation of ZMC fractures, with particular emphasis on malar height and vertical dystopia.
MATERIALS AND METHODS


A randomized clinical trial was conducted from August 2016 to October 2019 in which 40 adult patients with ZMC fractures of maxillofacial region were included. Patients were randomly allocated to group A (n = 20; frontozygomatic (F-Z) first 3-point reduction and fixation) or group B (n = 20; group B infra-orbital first 3-point reduction and fixation). All patients were evaluated objectively for malar height and vertical dystopia pre- and post-operatively at 3 months. The data were scrutinized by applying mean and standard deviation and unpaired t test.
RESULTS


Mean values of the malar height and vertical dystopia were statistically significant (P < .05) for group B compared with group A at all intervals. Data analyzed for other secondary variables showed a statistically non-significant difference between the groups (P > 0.05).
CONCLUSION


The results showed improvement in the malar height and vertical dystopia for infra-orbital first three-point fixation (group B) compared with F-Z first approach for initial reduction and fixation (group A). Furthermore, group B was better in terms of malar width and antero-posterior projection of the zygomaticomaxillary complex.",2020,Mean values of the malar height and vertical dystopia were statistically significant (P < .05) for group B compared with group A at all intervals.,"['patients who underwent distinctive types of open reduction and internal fixation of ZMC fractures, with particular emphasis on malar height and vertical dystopia', 'August 2016 to October 2019 in which 40 adult patients with ZMC fractures of maxillofacial region were included']",['frontozygomatic (F-Z) first 3-point reduction and fixation) or group B (n\u2009=\u200920; group B infra-orbital first 3-point reduction and fixation'],"['Mean values of the malar height and vertical dystopia', 'malar height and vertical dystopia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0043539', 'cui_str': 'Zygomatic bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0043539', 'cui_str': 'Zygomatic bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",40.0,0.0200943,Mean values of the malar height and vertical dystopia were statistically significant (P < .05) for group B compared with group A at all intervals.,"[{'ForeName': 'Rupshikha', 'Initials': 'R', 'LastName': 'Choudhury', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Regional Dental College, Guwahati, Assam, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Regional Dental College, Guwahati, Assam, India. docos79@gmail.com.'}, {'ForeName': 'Dharmendra', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, CKS Theja Dental College, Tirupati, India.'}, {'ForeName': 'Shanthi Prasad', 'Initials': 'SP', 'LastName': 'Indra', 'Affiliation': 'Department of Orthodontics, Sharavathi Dental College and Hospital, Shimoga, India.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Government Doon Medical College, Dehradun, Uttarakhand, India.'}, {'ForeName': 'Shreya', 'Initials': 'S', 'LastName': 'Jawalkar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, CKS Theja Dental College, Tirupati, India.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00905-z']
2648,32912597,Clustering patients by depression symptoms to predict venlafaxine ER antidepressant efficacy: Individual patient data analysis.,"OBJECTIVE


To identify clusters of patients with major depressive disorder (MDD) based on the baseline 17-item Hamilton Rating Scale for Depression (HAM-D 17 ) items and to evaluate the efficacy of venlafaxine extended release (VEN) vs placebo, and the potential effect of dose on efficacy, in each cluster.
METHODS


Cluster analysis was performed to identify clusters based on standardized HAM-D 17  item scores of individual patient data at baseline from 9 double-blind, placebo-controlled studies of VEN for MDD. Change from baseline in HAM-D 17  total score was analyzed using a mixed-effects model for repeated measures for each cluster; response and remission rates at week 8 were analyzed using logistic regression. Discontinuation rates were also evaluated in each cluster.
RESULTS


In 2599 patients, 3 patient clusters were identified, characterized as High modified Core (mCore) Symptoms/High Anxiety (cluster 1), High mCore Symptoms/Medium Anxiety (cluster 2), and Medium mCore Symptoms/Medium Anxiety (cluster 3). Significant effects of VEN vs placebo were observed on change from baseline in HAM-D 17  total score at week 8 for both clusters 1 and 2 (both P < 0.001), but not for cluster 3. In cluster 3, a significant treatment effect of VEN was observed at week 8 in the lower-dose subgroup but not in the higher-dose subgroup. All-cause discontinuation rates were significantly higher in placebo than VEN in each cluster.
CONCLUSIONS


Three unique clusters of patients were identified differing in baseline mCore symptoms and anxiety. Cluster membership may predict efficacy outcomes and contribute to dose effects in patients treated with VEN.
CLINICAL TRIALS REGISTRATION


NCT01441440; other studies included in this analysis were conducted before the requirement to register clinical studies took effect.",2020,"Significant effects of VEN vs placebo were observed on change from baseline in HAM-D 17  total score at week 8 for both clusters 1 and 2 (both P < 0.001), but not for cluster 3.","['patients with major depressive disorder (MDD', 'patients treated with VEN', '2599 patients, 3 patient clusters were identified, characterized as High modified Core (mCore) Symptoms/High Anxiety (cluster 1), High mCore Symptoms/Medium Anxiety (cluster 2), and Medium mCore Symptoms/Medium Anxiety (cluster 3']","['venlafaxine ER', 'placebo', 'venlafaxine extended release (VEN) vs placebo', 'VEN vs placebo']","['VEN', 'HAM-D 17  total score', 'remission rates', 'All-cause discontinuation rates', 'Discontinuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",2599.0,0.147044,"Significant effects of VEN vs placebo were observed on change from baseline in HAM-D 17  total score at week 8 for both clusters 1 and 2 (both P < 0.001), but not for cluster 3.","[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan. Electronic address: katom@takii.kmu.ac.jp.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Asami', 'Affiliation': 'Upjohn Medical Affairs, Pfizer Japan Inc., Tokyo, Japan.'}, {'ForeName': 'Dalia B', 'Initials': 'DB', 'LastName': 'Wajsbrot', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Syneos Health Inc., Raleigh, NC, USA.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boucher', 'Affiliation': 'Pfizer Canada Inc, Kirkland, Canada; McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Prieto', 'Affiliation': 'Pfizer GEP SLU, Madrid, Spain.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Pappadopulos', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.011']
2649,32912614,RETRACTED: Letrozole versus combined metformin and clomiphene citrate for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a randomized controlled trial.,,2020,,['clomiphene-resistant women with polycystic ovary syndrome'],"['metformin and clomiphene citrate', 'Letrozole']",[],"[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.189616,,"[{'ForeName': 'Hatem Abu', 'Initials': 'HA', 'LastName': 'Hashim', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Shokeir', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Departments of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1406']
2650,32912615,RETRACTED: Anastrozole or letrozole for ovulation induction in clomiphene-resistant women with polycystic ovarian syndrome: a prospective randomized trial.,,2020,,['clomiphene-resistant women with polycystic ovarian syndrome'],['Anastrozole or letrozole'],[],"[{'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.0622316,,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics & Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Mosbah', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Shady', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1407']
2651,32912616,RETRACTED: Clomiphene citrate or letrozole for ovulation induction in women with polycystic ovarian syndrome: a prospective randomized trial.,,2020,,['women with polycystic ovarian syndrome'],['Clomiphene citrate or letrozole'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]",[],,0.0407403,,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ibrahim Abdel', 'Initials': 'IA', 'LastName': 'Aal', 'Affiliation': 'Department of Clinical Pathology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abulatta', 'Affiliation': 'Department of Radiology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1408']
2652,32912617,RETRACTED: Clomiphene citrate or aromatase inhibitors for superovulation in women with unexplained infertility undergoing intrauterine insemination: a prospective randomized trial.,,2020,,['women with unexplained infertility undergoing intrauterine insemination'],['Clomiphene citrate or aromatase inhibitors'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]",[],,0.0401751,,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Badawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abubaker', 'Initials': 'A', 'LastName': 'Elnashar', 'Affiliation': 'Department of Obstetrics and Gynecology, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Totongy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mansoura University, Mansoura, Egypt.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.08.1409']
2653,32912627,Randomized clinical trial comparing of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in knee osteoarthritis.,"BACKGROUND


Due to the limitations of pharmacological and surgical management of knee osteoarthritis (OA), several non-pharmacologic approaches including transcutaneous electrical nerve stimulation (TENS) and transcranial direct current stimulation (tDCS) have been introduced, with promising results.
OBJECTIVE


We aimed to investigate and compare the therapeutic effects of TENS and tDCS for the treatment of patients with knee OA.
METHODS


In this double-blinded randomized controlled trial, a total of 40 adult patients with knee OA were randomly allocated to either the TENS or the tDCS group. Patients in either group received 6 sessions of the TENS or tDCS for 2 weeks. Knee strengthening exercises were performed twice daily for the entire treatment period. Patients were evaluated using the visual analogue scale (VAS) and Western Ontario and McMaster Universities (WOMAC).
RESULTS


Significant improvement was observed in all outcomes in both TENS and tDCS groups at each follow up compared to baseline although the early improvement (first follow-up) in the WOMAC index was not significant in the TENS group. Based on the within-subject analysis, the behavior of two treatment groups did not differ regarding the changes in the course of the VAS, WOMAC score and its subscales, i.e. stiffness, pain and function (p = 0.263, 0.051, 0.198, 0.075, and 0.146, respectively).
CONCLUSIONS


Based on the results of this study, the effect of tDCS and TENS was not significantly different on pain and function of patients with knee OA.",2020,"Based on the within-subject analysis, the behavior of two treatment groups did not differ regarding the changes in the course of the VAS, WOMAC score and its subscales, i.e. stiffness, pain and function (p = 0.263, 0.051, 0.198, 0.075, and 0.146, respectively).
","['knee osteoarthritis (OA', 'knee osteoarthritis', '40 adult patients with knee OA', 'patients with knee OA']","['TENS or tDCS', 'transcutaneous electrical nerve stimulation (TENS) and transcranial direct current stimulation (tDCS', 'TENS or the tDCS', 'Knee strengthening exercises', 'transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS', 'TENS and tDCS', 'tDCS and TENS', 'TENS']","['visual analogue scale (VAS) and Western Ontario and McMaster Universities (WOMAC', 'WOMAC index', 'pain and function', 'VAS, WOMAC score and its subscales, i.e. stiffness, pain and function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",40.0,0.0348402,"Based on the within-subject analysis, the behavior of two treatment groups did not differ regarding the changes in the course of the VAS, WOMAC score and its subscales, i.e. stiffness, pain and function (p = 0.263, 0.051, 0.198, 0.075, and 0.146, respectively).
","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Sajadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Karimi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forogh', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Raissi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Forugh', 'Initials': 'F', 'LastName': 'Zarnegar', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Ahadi.t@iums.ac.ir.'}]",Neurophysiologie clinique = Clinical neurophysiology,['10.1016/j.neucli.2020.08.005']
2654,32912741,Effect of large diameter and plasma coating on the initial adaptation of gas permeable contact lens fitting for neophytes.,"PURPOSE


To determine whether the adaption of neophytes to rigid gas permeable lenses (GPs) could be accelerated by changing their diameter or surface lubricity.
METHODS


This was a 2 part prospective double-masked randomised wear study. An GP lens (Roflufocon D material, 9.6 mm diameter) with and without a Hydrapeg plasma coating surface was worn by 119 neophytes (21.1 ± 3.5 years; 77% female) on separate occasions. A further 114 neophytes (average age 20.1 ± 1.0 years; 72% female) wore the uncoated lens with a 9.6 mm diameter lens in one randomly allocated eye and 10.1 mm (n = 51) or 10.6 mm (n = 63) in the other with a basecurve compensation keeping the fit equivalent. Lens fit and corneal staining was assessed after 20 min, and comfort and bulbar redness were assessed at the time of lens application and after 5, 10, 15, and 20 min. Participants also reported their ease of application and removal on a 5 point scale.
RESULTS


Plasma coated GP lenses or increasing diameter did not improve comfort (p = 0.673, p > 0.05) or bulbar redness (p = 0.805, p > 0.05) during a 20 min adaptation period in neophytes. In both cohorts, comfort improved and bulbar redness reduced with time (p < 0.001). Corneal staining, ease of insertion application and ease of removal did not differ with GP coating application or GP diameter (p > 0.05).
CONCLUSION


Changing GP diameter or surface lubricity is not beneficial to the adaption of healthy neophytes.",2020,"RESULTS


Plasma coated GP lenses or increasing diameter did not improve comfort (p = 0.673, p > 0.05) or bulbar redness (p = 0.805, p > 0.05) during a 20 min adaptation period in neophytes.","['neophytes', 'A further 114 neophytes (average age 20.1 ± 1.0 years; 72% female) wore the uncoated lens with a 9.6 mm diameter lens']",['rigid gas permeable lenses (GPs'],"['Corneal staining, ease of insertion application and ease of removal', 'comfort and bulbar redness', 'Lens fit and corneal staining', 'bulbar redness']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]","[{'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0444946', 'cui_str': 'Gas permeable'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]",,0.057077,"RESULTS


Plasma coated GP lenses or increasing diameter did not improve comfort (p = 0.673, p > 0.05) or bulbar redness (p = 0.805, p > 0.05) during a 20 min adaptation period in neophytes.","[{'ForeName': 'Dutta', 'Initials': 'D', 'LastName': 'Debarun', 'Affiliation': 'Optometry and Vision Science Research Group, Optometry School, Aston University, UK.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Optometry and Vision Science Research Group, Optometry School, Aston University, UK. Electronic address: J.S.W.Wolffsohn@aston.ac.uk.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.08.009']
2655,32912759,Prevention of pressure injuries in critically ill children: A preliminary evaluation.,"AIMS


To evaluate a prevention strategy implemented to reduce incidence and severity of positioning related pressure injuries affecting pediatric patients in a pediatric critical care unit. Secondary objective was to evaluate compliance with preventive recommendations.
BACKGROUND


The skin in infants or children has important physiological and anatomical differences compared with adults. Further, factors such as the immaturity of the skin and limited activity and mobility in pediatric critical care unit, along with the pressure exerted by medical devices, increases the risk of pressure ulcers in infants and children. The most effective preventive measures specific to this intensive care population need to be evaluated.
MATERIAL AND METHODS


Quasi-experimental before-after study with consecutive sampling. The effectiveness of the care bundle implementation was evaluated based on the latest evidence (intervention group) versus the application of non-standardized care (control group). Pediatric patients up to 14 years old at risk of suffering from pressure injuries and who were admitted more than 48 h in a pediatric intensive care unit (level III) participated. For the collection of data, two computer programs and the hospital clinical records of each participant were consulted. The data collection period was 6 months per group (pre and post intervention).
RESULTS


A sample of 110 patients was obtained (50 control group and 60 intervention group). The cumulative incidence in pediatric patients exposed to the risk of pressure injuries was reduced from 16% to 13.3%; and in the subgroup of patients with prolonged stay (≥28 days), the incidence was reduced from 55.55% to 20%. In the intervention group, category III and IV pressure ulcers were completely reduced. In addition, the total number of pressure injuries decreased by 21.43%. The care bandle recommendations with the highest level of adhesion recorded were: skin inspection, application of hyperoxygenated fatty acids and use of a special support surface. The main risk factor found during the study was the prone position (p < 0.05).
CONCLUSIONS


The application of a care bundle for prevention can be an effective solution to reduce the number and severity of LPPs in an intensive care unit. The most vulnerable subgroup of patients may benefit from the application of these resources.",2020,"The cumulative incidence in pediatric patients exposed to the risk of pressure injuries was reduced from 16% to 13.3%; and in the subgroup of patients with prolonged stay (≥28 days), the incidence was reduced from 55.55% to 20%.","['Quasi-experimental before-after study with consecutive sampling', 'pediatric patients in a pediatric critical care unit', 'Pediatric patients up to 14 years old at risk of suffering from pressure injuries and who were admitted more than 48\xa0h in a pediatric intensive care unit (level III) participated', '110 patients was obtained (50 control group and 60 intervention group', 'pediatric patients', 'critically ill children', 'infants and children']",[],"['total number of pressure injuries', 'category III and IV pressure ulcers', 'risk of pressure injuries', 'cumulative incidence']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0445134', 'cui_str': 'Number of pressure ulcers'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.02646,"The cumulative incidence in pediatric patients exposed to the risk of pressure injuries was reduced from 16% to 13.3%; and in the subgroup of patients with prolonged stay (≥28 days), the incidence was reduced from 55.55% to 20%.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bargos-Munárriz', 'Affiliation': 'Pediatric Working Group of the Commission for the Prevention and Treatment of Pressure Ulcer and Wounds. Regional University Hospital of Malaga, Spain; Pediatric Intensive Care Unit. Regional University Hospital of Malaga, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Bermúdez-Pérez', 'Affiliation': 'Pediatric Working Group of the Commission for the Prevention and Treatment of Pressure Ulcer and Wounds. Regional University Hospital of Malaga, Spain; Pediatric Intensive Care Unit. Regional University Hospital of Malaga, Spain.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Martínez-Alonso', 'Affiliation': 'Pediatric Working Group of the Commission for the Prevention and Treatment of Pressure Ulcer and Wounds. Regional University Hospital of Malaga, Spain; Pediatric Intensive Care Unit. Regional University Hospital of Malaga, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'García-Molina', 'Affiliation': 'Department of Nursing. University of Valencia, Spain; Nursing Care Research Group. INCLIVA Biomedical Research Institute, Spain. Electronic address: pagarmo3@uv.es.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Orts-Cortés', 'Affiliation': 'Department of Nursing. University of Alicante, Alicante Institute for Health and Biomedical Research (ISABIAL)Alicante, Spain; Nursing and Healthcare Research Unit (Investén-isciii), CIBERFES, Instituto de Salud Carlos III, Madrid, Spain.'}]",Journal of tissue viability,['10.1016/j.jtv.2020.08.005']
2656,32910531,Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies.,"OBJECTIVE


Metabolic syndrome (MetS) is a cluster of concurrent risk factors for cardiovascular disease and type 2 diabetes. This post hoc analysis explored key efficacy and safety endpoints in patients with psoriatic arthritis (PsA) and MetS treated with tofacitinib.
METHODS


Tofacitinib 5 and 10 mg twice daily and placebo data were pooled from two Phase 3 studies (OPAL Broaden [12 months; ClinicalTrials.gov identifier NCT01877668]; OPAL Beyond [6 months; ClinicalTrials.gov identifier NCT01882439]); patients received one background conventional synthetic disease-modifying antirheumatic drug. Patients were stratified by baseline presence/absence of MetS. Efficacy and safety were reported to month 3 (tofacitinib and placebo) and 6 (tofacitinib only). Efficacy outcomes included: American College of Rheumatology (ACR)20/50/70, Health Assessment Questionnaire-Disability Index (HAQ-DI) response, Psoriasis Area Severity Index (PASI)75 response, and enthesitis/dactylitis resolution rates; and changes from baseline (Δ) in C-reactive protein, HAQ-DI, Patient's/Physician's Global Assessment of Arthritis, and patient-reported outcomes. Safety outcomes included treatment-emergent all-causality adverse events (AEs), Δ in lipid/hepatic values, and liver parameter increases.
RESULTS


Of 710 patients, 41.4% (n = 294) had baseline MetS. All efficacy outcomes improved with both tofacitinib doses versus placebo, to month 3; tofacitinib efficacy was consistent to month 6, regardless of MetS status. MetS did not appear to affect the incidence of AEs or Δ in lipid/hepatic values with tofacitinib up to month 3 or 6. Arterial thromboembolism and myocardial infarction (adjudicated major adverse cardiovascular events) were each reported once in tofacitinib-treated patients with MetS.
CONCLUSION


Regardless of baseline MetS status, tofacitinib showed greater efficacy versus placebo in patients with active PsA. The tofacitinib safety profile appeared similar in patients with versus without MetS.",2020,MetS did not appear to affect the incidence of AEs or Δ in lipid/hepatic values with tofacitinib up to month 3 or 6.,"['patients with psoriatic arthritis (PsA) and MetS treated with tofacitinib', 'patients with versus without MetS', 'Of 710 patients, 41.4% (n = 294) had baseline MetS', 'patients with active PsA', 'Patients With Psoriatic Arthritis and Metabolic Syndrome']","['placebo', 'Tofacitinib 5 and 10 mg twice daily and placebo', 'background conventional synthetic disease-modifying antirheumatic drug', 'Tofacitinib']","['Arterial thromboembolism and myocardial infarction', ""American College of Rheumatology (ACR)20/50/70, Health Assessment Questionnaire-Disability Index (HAQ-DI) response, Psoriasis Area Severity Index (PASI)75 response, and enthesitis/dactylitis resolution rates; and changes from baseline (Δ) in C-reactive protein, HAQ-DI, Patient's/Physician's Global Assessment of Arthritis, and patient-reported outcomes"", 'tofacitinib safety profile', 'Safety outcomes included treatment-emergent all-causality adverse events (AEs), Δ in lipid/hepatic values, and liver parameter increases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C3544094', 'cui_str': 'Arterial thromboembolism'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1282952', 'cui_str': 'Enthesitis'}, {'cui': 'C0239161', 'cui_str': 'Dactylitis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",710.0,0.457719,MetS did not appear to affect the incidence of AEs or Δ in lipid/hepatic values with tofacitinib up to month 3 or 6.,"[{'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Ritchlin', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Giles', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Gomez-Reino', 'Affiliation': 'Hospital Clínico Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Helliwell', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Cunshan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Pfizer Inc, Groton, Connecticut.'}, {'ForeName': 'Ana Belén', 'Initials': 'AB', 'LastName': 'Romero', 'Affiliation': 'Pfizer Inc, Barcelona, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Woolcott', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Stockert', 'Affiliation': 'Pfizer Inc, Collegeville, Pennsylvania.'}]",ACR open rheumatology,['10.1002/acr2.11166']
2657,32910653,Efficient training of machine-learning potentials by randomized atomic-system generator.,"Machine learning potentials provide an efficient and comprehensive tool to simulate large scale systems inaccessible by conventional first-principles methods still in a similar level of accuracy. One critical issue in constructing machine learning potentials is to build training data sets cost-effectively that can represent the potential energy surface in a wide range of configurations. We develop a scheme named randomized atomic-system generator to produce the training sets that widely cover the potential energy surface by combining the random sampling and structural optimization. We apply the scheme to construct the machine learning potentials for simulation of chalcogen-based phase change materials. Constructed machine-learning potentials successfully simulate the dynamics of melting and crystallization processes of binary GeTe at a level comparable to first-principles simulations. The visual analysis shows that the RAG-generated training set represents the crystallization process including the amorphous phases. From the velocity autocorrelation function obtained from the molecular-dynamics simulations, we calculate the phonon density of states to analyze the vibrational properties during crystallization.",2020,Machine learning potentials provide an efficient and comprehensive tool to simulate large scale systems inaccessible by conventional first-principles methods still in a similar level of accuracy.,[],[],[],[],[],[],1.0,0.0164004,Machine learning potentials provide an efficient and comprehensive tool to simulate large scale systems inaccessible by conventional first-principles methods still in a similar level of accuracy.,"[{'ForeName': 'Young-Jae', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Jhi', 'Affiliation': ''}]",The journal of physical chemistry. B,['10.1021/acs.jpcb.0c05075']
2658,32910709,Hypofractionated Versus Standard Fractionated Radiotherapy in Patients With Early Breast Cancer or Ductal Carcinoma In Situ in a Randomized Phase III Trial: The DBCG HYPO Trial.,"PURPOSE


Given the poor results using hypofractionated radiotherapy for early breast cancer, a dose of 50 Gy in 25 fractions (fr) has been the standard regimen used by the Danish Breast Cancer Group (DBCG) since 1982. Results from more recent trials have stimulated a renewed interest in hypofractionation, and the noninferiority DBCG HYPO trial (ClincalTrials.gov identifier: NCT00909818) was designed to determine whether a dose of 40 Gy in 15 fr does not increase the occurrence of breast induration at 3 years compared with a dose of 50 Gy in 25 fr.
PATIENTS AND METHODS


One thousand eight hundred eighty-two patients > 40 years of age who underwent breast-conserving surgery for node-negative breast cancer or ductal carcinoma in situ (DCIS) were randomly assigned to radiotherapy at a dose of either 50 Gy in 25 fr or 40 Gy in 15 fr. The primary end point was 3-year grade 2-3 breast induration assuming noninferiority regarding locoregional recurrence.
RESULTS


A total of 1,854 consenting patients (50 Gy, n = 937; 40 Gy, n = 917) were enrolled from 2009-2014 from eight centers. There were 1,608 patients with adenocarcinoma and 246 patients with DCIS. The 3-year rates of induration were 11.8% (95% CI, 9.7% to 14.1%) in the 50-Gy group and 9.0% (95% CI, 7.2% to 11.1%) in the 40-Gy group (risk difference, -2.7%; 95% CI, -5.6% to 0.2%;  P  = .07). Systemic therapies and radiotherapy boost did not increase the risk of induration. Telangiectasia, dyspigmentation, scar appearance, edema, and pain were detected at low rates, and cosmetic outcome and patient satisfaction with breast appearance were high with either no difference or better outcome in the 40-Gy cohort compared with the 50-Gy cohort. The 9-year risk of locoregional recurrence was 3.3% (95% CI, 2.0% to 5.0%) in the 50-Gy group and 3.0% (95% CI, 1.9% to 4.5%) in the 40-Gy group (risk difference, -0.3%; 95% CI, -2.3% to 1.7%). The 9-year overall survival was 93.4% (95% CI, 91.1% to 95.1%) in the 50-Gy group and 93.4% (95% CI, 91.0% to 95.2%) in the 40-Gy group. The occurrence of radiation-associated cardiac and lung disease was rare and not influenced by the fractionation regimen.
CONCLUSION


Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy. Other normal tissue effects were minimal, with similar or less frequent rates in the 40-Gy group. The 9-year locoregional recurrence risk was low.",2020,Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy.,"['1,854 consenting patients (50 Gy, n = 937; 40 Gy, n = 917) were enrolled from 2009-2014 from eight centers', 'One thousand eight hundred eighty-two patients > 40 years of age who underwent breast-conserving surgery for node-negative breast cancer or ductal carcinoma in situ (DCIS', 'Patients With Early Breast Cancer or Ductal Carcinoma', '1,608 patients with adenocarcinoma and 246 patients with DCIS']","['DCIS', 'radiotherapy', 'Hypofractionated Versus Standard Fractionated Radiotherapy', 'hypofractionated radiotherapy']","['9-year risk of locoregional recurrence', '9-year overall survival', 'risk of induration', 'occurrence of radiation-associated cardiac and lung disease', 'occurrence of breast induration', 'cosmetic outcome and patient satisfaction with breast appearance', '9-year locoregional recurrence risk', '3-year grade 2-3 breast induration assuming noninferiority regarding locoregional recurrence', 'Telangiectasia, dyspigmentation, scar appearance, edema, and pain', '3-year rates of induration']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191378', 'cui_str': '917'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]","[{'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332534', 'cui_str': 'Induration'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}, {'cui': 'C0269268', 'cui_str': 'Induration of breast'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1286082', 'cui_str': 'Appearance of breast'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C1260926', 'cui_str': 'Abnormal pigmentation'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",917.0,0.225583,Moderately hypofractionated breast irradiation of node-negative breast cancer or DCIS did not result in more breast induration compared with standard fractionated therapy.,"[{'ForeName': 'Birgitte V', 'Initials': 'BV', 'LastName': 'Offersen', 'Affiliation': 'Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Alsner', 'Affiliation': 'Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hanne M', 'Initials': 'HM', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Erik H', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Oncology, Lillebaelt Hospital, Vejle, Denmark.'}, {'ForeName': 'Mette H', 'Initials': 'MH', 'LastName': 'Nielsen', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Radiation Oncology and OncoRay Center, University Hospital and Faculty of Medicine Carl Gustav Carus; Technische Universität Dresden; German Cancer Consortium Dresden; Helmholtz-Zentrum Dresden-Rossendorf; National Center for Tumor Diseases, Dresden; and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Stenbygaard', 'Affiliation': 'Department of Oncology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Ingvil', 'Initials': 'I', 'LastName': 'Mjaaland', 'Affiliation': 'Department of Oncology, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schreiber', 'Affiliation': 'Department of Oncology, Academic Teaching Hospital Dresden-Friedrichstadt, Dresden, Germany.'}, {'ForeName': 'Unn-Miriam', 'Initials': 'UM', 'LastName': 'Kasti', 'Affiliation': 'Department of Oncology, Kristiansand Hospital, Kristiansand, Norway.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Overgaard', 'Affiliation': 'Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01363']
2659,32910710,Continuous Versus 1-Year Fixed-Duration Nivolumab in Previously Treated Advanced Non-Small-Cell Lung Cancer: CheckMate 153.,"PURPOSE


Limited data exist on the optimal duration of immunotherapy, including for non-small-cell lung cancer (NSCLC). We present an exploratory analysis of CheckMate 153, a largely community-based phase IIIb/IV study, to evaluate the impact of 1-year fixed-duration versus continuous therapy on the efficacy and safety of nivolumab.
METHODS


Patients with previously treated advanced NSCLC received nivolumab monotherapy (3 mg/kg every 2 weeks). Those still receiving treatment at 1 year, including patients perceived to be deriving benefit despite radiographic progression, were randomly assigned to continue nivolumab until disease progression or unacceptable toxicity or to stop nivolumab with the option of on-study retreatment after disease progression (1-year fixed duration).
RESULTS


Of 1,428 patients treated, 252 were randomly assigned to continuous (n = 127) or 1-year fixed-duration (n = 125) treatment (intent-to-treat [ITT] population). Of these, 89 and 85 patients in the continuous and 1-year fixed-duration arms, respectively, had not progressed (progression-free survival [PFS] population). With minimum post-random assignment follow-up of 13.5 months, median PFS was longer with continuous versus 1-year fixed-duration treatment (PFS population: 24.7 months  v  9.4 months; hazard ratio [HR], 0.56 [95% CI, 0.37 to 0.84]). Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached  v  32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached  v  28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations. Few new-onset treatment-related adverse events occurred. No new safety signals were identified.
CONCLUSION


To our knowledge, these findings from an exploratory analysis represent the first randomized data on continuous versus fixed-duration immunotherapy in previously treated advanced NSCLC and suggest that continuing nivolumab beyond 1 year improves outcomes.",2020,"Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached  v  32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached  v  28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations.","['1,428 patients treated', 'Patients with previously treated advanced NSCLC received']","['nivolumab monotherapy', 'Continuous Versus 1-Year Fixed-Duration Nivolumab']","['Median overall survival', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1428.0,0.208119,"Median overall survival from random assignment was longer with continuous versus 1-year fixed-duration treatment in the PFS (not reached  v  32.5 months; HR, 0.61 [95% CI, 0.37 to 0.99]) and ITT (not reached  v  28.8 months; HR, 0.62 [95% CI, 0.42 to 0.92]) populations.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Waterhouse', 'Affiliation': 'The US Oncology Network/Oncology Hematology Care, Cincinnati, OH.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at UCLA/Translational Research in Oncology-US Network, Los Angeles, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'West Cancer Center, Memphis, TN.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCleod', 'Affiliation': 'Sarah Cannon Research Institute/Florida Cancer Specialists, Cape Coral, FL.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Sarah Cannon Research Institute/Florida Cancer Specialists, The Villages, FL.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jotte', 'Affiliation': 'The US Oncology Network/Rocky Mountain Cancer Centers, Denver, CO.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Davey B', 'Initials': 'DB', 'LastName': 'Daniel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Chattanooga, TN.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Keogh', 'Affiliation': 'Charleston Oncology, Charleston, SC.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Creelan', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Einhorn', 'Affiliation': 'Simon Cancer Center, Indiana University, Indianapolis, IN.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Jackson Oncology Associates, Jackson, MS.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Kasbari', 'Affiliation': 'Southeastern Medical Oncology Center, Goldsboro, NC.'}, {'ForeName': 'Petros', 'Initials': 'P', 'LastName': 'Nikolinakos', 'Affiliation': 'Hematology and Medical Oncology, University Cancer and Blood Center, LLC, Athens, GA.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Fort Wayne Medical Oncology and Hematology, Fort Wayne, IN.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Couture', 'Affiliation': 'CISSS Chaudiéere-Appalaches, Levis, Quebec, Canada.'}, {'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Sarah Cannon Research Institute/Florida Cancer Specialists, Ocala, FL.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Gunuganti', 'Affiliation': 'Texas Oncology, San Antonio, TX.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ.'}, {'ForeName': 'Nivedita', 'Initials': 'N', 'LastName': 'Aanur', 'Affiliation': 'Bristol-Myers Squibb Company, Princeton, NJ.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00131']
2660,32910712,Effect of video-assisted education on informed consent and patient education for peripherally inserted central catheters: a randomized controlled trial.,"OBJECTIVE


To evaluate the effects of a video-assisted education intervention on informed consent and patient education for peripherally inserted central catheters (PICCs).
METHODS


We conducted a randomized controlled trial comparing the effects on informed consent of video-assisted patient education and traditional face-to-face discussion in a catheter outpatient ward of a cancer centre in Guangzhou, China, in 2018. Participants were 140 patients randomly allocated (1:1 ratio) to two groups: video-assisted or traditional intervention. General information, patient retention of PICC-related information, working time spent by nurses on the procedure, and patient and nurse satisfaction with the procedure were assessed.
RESULTS


The time used for informed consent was significantly shorter in the experimental group (1.02 ± 0.24 minutes) than in the control group (6.87 ± 1.10 minutes). The time used for PICC-related education was significantly shorter in the experimental group (1.03 ± 0.28 minutes) than in the control group (5.11 ± 0.57 minutes). Nurses' degree of satisfaction with the procedure was significantly higher in the experimental group (4.10 ± 0.57) than in the control group (2.60 ± 0.70).
CONCLUSION


The use of video-assisted informed consent and patient education in this cancer centre decreased nurses' working time and improved nurses' satisfaction.Clinical trial registration number: ChiCTR1800015664.",2020,The time used for informed consent was significantly shorter in the experimental group (1.02 ± 0.24 minutes) than in the control group (6.87 ± 1.10 minutes).,"['peripherally inserted central catheters', 'catheter outpatient ward of a cancer centre in Guangzhou, China, in 2018']","['video-assisted education intervention', 'video-assisted or traditional intervention', 'video-assisted education', 'video-assisted patient education and traditional face-to-face discussion', 'video-assisted informed consent and patient education']","[""Nurses' degree of satisfaction with the procedure"", 'time used for informed consent', 'time used for PICC-related education']","[{'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",140.0,0.116557,The time used for informed consent was significantly shorter in the experimental group (1.02 ± 0.24 minutes) than in the control group (6.87 ± 1.10 minutes).,"[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Catheter Outpatient Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xue-Fang', 'Initials': 'XF', 'LastName': 'Huang', 'Affiliation': 'Department of Outpatient Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jie-Lin', 'Initials': 'JL', 'LastName': 'Luo', 'Affiliation': 'Department of Catheter Outpatient Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jiang-Yun', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Department of Outpatient Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Liang', 'Affiliation': 'Department of Outpatient Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chun-Li', 'Initials': 'CL', 'LastName': 'Huang', 'Affiliation': 'Department of Outpatient Center, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hui-Ying', 'Initials': 'HY', 'LastName': 'Qin', 'Affiliation': 'Department of Nursing, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}]",The Journal of international medical research,['10.1177/0300060520947915']
2661,32911009,Tooth replacement options for partially dentate older adults: a survival analysis.,"OBJECTIVES


To compare the success of two different tooth replacement strategies for partially dentate older adults; namely resin bonded bridgework (RBB) provided to restore patients according to the principles of the shortened dental arch concept (SDA) and conventional full-arch rehabilitation with removable dental prostheses (RDPs).
METHODS


A randomised controlled clinical trial (RCT) was conducted with partially dentate adults aged 65 years or older. Each patient from the RDP group had all missing natural teeth replaced with cobalt-chromium framework RDPs. Each patient from the SDA group was restored to 10 occluding pairs of natural and replacement teeth using RBB. Patients were followed-up at 6, 12, 24, 36 months. Success rates were generated according to defined success criteria. Log-rank tests and Cox's proportional hazard models were used to compare the success of the two treatment strategies.
RESULTS


After 36 months, 89 patients completed the RCT; n = 45 in the RDP group and n = 44 in the SDA group. The overall success rate of the SDA treatment was 90.4% compared to 73.0% for RDPs (p = 0.005). In the upper arch SDA treatment was 100% successful compared to 86.4% for RDPs (p = 0.019). In the lower arch, lower success rates were reported for both the SDA treatment (80.0%) and RDPs (60.0%) (p = 0.054). Further analyses with cox's proportional hazard models demonstrated that SDA treatment was significantly more successful than RDPs (Hazard Ratio: 2.47, p = 0.04).
CONCLUSIONS


After 36 months SDA treatment using RBB was significantly more successful than RDPs used for conventional full-arch rehabilitation in partially dentate older adults.
CLINICAL SIGNIFICANCE


Functionally orientated treatment according to the principles of the SDA is a feasible alternative to RDPs for partially dentate older patients. SDA treatment using RBB can achieve higher success rates compared to RDPs in this patient group.",2020,"After 36 months SDA treatment using RBB was significantly more successful than RDPs used for conventional full-arch rehabilitation in partially dentate older adults.
","['partially dentate older patients', 'partially dentate older adults', 'partially dentate adults aged 65\u2009years or older']","['resin bonded bridgework (RBB', 'shortened dental arch concept (SDA) and conventional full-arch rehabilitation with removable dental prostheses (RDPs']","['success rates', 'overall success rate', 'Success rates', 'RDPs']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}]",,0.0498701,"After 36 months SDA treatment using RBB was significantly more successful than RDPs used for conventional full-arch rehabilitation in partially dentate older adults.
","[{'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'McKenna', 'Affiliation': ""Centre for Public Health, Queen's University, Belfast, United Kingdom. Electronic address: g.mckenna@qub.ac.uk.""}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'McLister', 'Affiliation': 'School of Dentistry, Belfast Health and Social Care Trust, Royal Victoria Hospital Belfast, United Kingdom. Electronic address: conor.mclister@belfasttrust.hscni.net.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Tada', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, United Kingdom. Electronic address: sayaka.tada@nus.edu.sg.'}, {'ForeName': 'Cristiane', 'Initials': 'C', 'LastName': 'DaMata', 'Affiliation': 'Cork University Dental School and Hospital, University College Cork, United Kingdom. Electronic address: cristiane.damata@ucc.ie.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Hayes', 'Affiliation': 'Cork University Dental School and Hospital, University College Cork, United Kingdom. Electronic address: martina.hayes@ucc.ie.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cronin', 'Affiliation': 'School of Mathematical Sciences, University College Cork, United Kingdom. Electronic address: m.cronin@ucc.ie.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': ""Centre for Public Health, Queen's University, Belfast, United Kingdom. Electronic address: cmoore49@qub.ac.uk.""}, {'ForeName': 'Finbarr', 'Initials': 'F', 'LastName': 'Allen', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, United Kingdom. Electronic address: denpfa@nus.edu.sg.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103468']
2662,32911037,Chronotherapeutic efficacy of suvorexant on sleep quality and metabolic parameters in patients with type 2 diabetes and insomnia.,"AIMS


This study aimed to assess the chronotherapeutic efficacy of suvorexant on subjective sleep parameters and metabolic parameters in patients with type 2 diabetes and insomnia.
METHODS


Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks. The following parameters were assessed before and after the treatment: sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake.
RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight. Correlation analysis revealed that changes in sSE were associated with those in HbA1c and body weight (r=-0.61 and r=-0.66, respectively; both p<0.05).
CONCLUSIONS


Suvorexant significantly improved sleep quality and obesity-associated parameters in patients with type 2 diabetes in 14 weeks. Improvements in sleep quality were associated with improvements in glycemic control. Sleep disorder treatment using suvorexant may provide metabolic benefits for patients with type 2 diabetes.",2020,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","['patients with type 2 diabetes in 14 weeks', 'Thirteen patients with type 2 diabetes who met the Pittsburg Sleep Quality index criteria for primary insomnia took suvorexant 20 mg/day (15 mg/day for ≥65 years) for 14±2 weeks', 'patients with type 2 diabetes and insomnia', 'patients with type 2 diabetes']",['suvorexant'],"['sleep quality and obesity-associated parameters', 'glycemic control', 'sleep diary for sleep duration and quality (i.e., sleep onset latency, waking after sleep onset, and sleep efficiency [sSE]), Insomnia Severity Index, clinical and biochemical data, continuous glucose monitoring (CGM), and validated self-administered questionnaire on food intake', 'HbA1c and body weight', 'change HbA1c, CGM parameters, or body weight', 'Chronotherapeutic efficacy', 'sleep quality and metabolic parameters', 'subjective sleep parameters and metabolic parameters', 'sleep quality', 'sSE, abdominal circumference, and sucrose intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3854984', 'cui_str': 'suvorexant 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C3179535', 'cui_str': 'suvorexant'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference'}, {'cui': 'C0556137', 'cui_str': 'Sucrose intake'}]",13.0,0.026373,"RESULTS


Suvorexant significantly improved sSE, abdominal circumference, and sucrose intake (all p<0.05), but did not change HbA1c, CGM parameters, or body weight.","[{'ForeName': 'Fukumi', 'Initials': 'F', 'LastName': 'Yoshikawa', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Fumika', 'Initials': 'F', 'LastName': 'Shigiyama', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Yasuyo', 'Initials': 'Y', 'LastName': 'Ando', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Uchino', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Takahisa', 'Initials': 'T', 'LastName': 'Hirose', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Kumashiro', 'Affiliation': 'Division of Diabetes, Metabolism, and Endocrinology, Department of Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan. Electronic address: naoki.kumashiro@med.toho-u.ac.jp.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108412']
2663,32911132,A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.,"BACKGROUND


Medication for opioid use disorder (MOUD) can decrease the risk of opioid overdose (OOD) in individuals with opioid use disorder. Peer recovery support services (PRSS) are increasingly used to promote MOUD engagement but evidence of their efficacy is limited. This study's objective was to evaluate a single 20-minute telephone-delivered PRSS intervention for increasing MOUD enrollment and decreasing recurring OODs.
METHOD


This single-site, randomized controlled pilot trial enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months. Participants (N = 80) were randomized to PRSS (n = 40) or Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone. Outcome measures obtained at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization included verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS.
RESULTS


Through 12-month follow-up, 32.5 % of PRSS, compared to 17.5 % of Control participants enrolled in MOUD (X 2  = 2.4, p = 0.12; odds ratio = 2.27 (0.79-6.49)). PRSS participants were significantly less likely to have experienced an OOD through 12-month follow-up (12.5 % of PRSS participants, 32.5 % of Control, p = 0.03). No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days. Based on self-report, PRSS had good acceptability for both the interventionists and participants.
CONCLUSIONS


The results suggest that further development and testing of this PRSS telephone intervention to encourage MOUD enrollment and reduce OOD may be warranted.",2020,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"['individuals with opioid use disorder', 'Participants (N = 80', 'individuals surviving an opioid overdose', 'enrolled adults, primarily recruited from a syringe service program, with an opioid-positive urine drug screen (UDS) reporting having been treated for an OOD within the past 6 months']","['PRSS', 'PRSS telephone intervention', 'Control (n = 40) condition with all participants receiving personally-tailored OOD education and naloxone', 'Peer recovery support services (PRSS', 'telephone-delivered PRSS intervention', 'telephone-delivered peer intervention']","['verified MOUD enrollment (primary), self-reported OOD, and opioid use assessed by self-report and UDS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0743300', 'cui_str': 'Urine drug screen positive'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}]",80.0,0.0748964,No significant treatment effect was found for opioid use through 12-month follow-up as measured by either opioid-positive UDSs or self-reported past month opioid use days.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH, 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108270']
2664,32911138,"Short-term oral corticosteroids for initial treatment of moderate-to-severe persistent asthma: A double-blind, randomized, placebo-controlled trial.","BACKGROUND AND PURPOSE


The purpose of this study was to investigate that on the basis of ICS-LABA treatment, whether or not adding on short course of oral corticosteroid could increase the rate of asthma control.
METHODOLOGY


This was a double blind, randomized controlled study. Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic. All patients included in the study received ICS-LABA as initial treatment. Two weeks oral corticosteroid or placebo were added on at the beginning of treatment. All the subjects were followed-up by daily measurement of PEF and asthma diary for 12 week and spirometry at 4 weeks and 12 weeks.
RESULTS


13 cases were randomized to Corticosteroid group (M/F: 9/4, age: 45.0 ± 5.0 yrs), 11 to Placebo group (M/F: 4/7, age: 35.7 ± 9.6yrs). After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05). However, there were no significant difference between two groups in the improvement of ACT、ACQ、AQLQ、FEV1、FEV1% (all P > 0.05). After 4 weeks of treatment, total control was achieved in 3 (30.8%) in corticosteroid group and 2 (18.2%) in placebo group; Partial control was achieved in 7 (61.5%)in corticosteroid group and in 7 (63.6%) in placebo group. There was no significant difference in control rates between two groups (X 2  = 0.919, P = 0.632). Similar findings were observed after 12 weeks of treatment.
CONCLUSION


In maintenance treatment naïve moderate to severe persistent asthma, ICS-LABA therapy was adequate initial treatment for achieving asthma control in majority of the patients. Add on short course of oral corticosteroid provided no significant clinical benefit.",2020,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","['moderate-to-severe persistent asthma', '13 cases', 'Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic']","['Short-term oral corticosteroids', 'corticosteroid or placebo', 'placebo', 'ICS-LABA', 'Corticosteroid', 'Placebo']","['total control', 'control rates', 'rate of asthma control']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",13.0,0.251154,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","[{'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dongming', 'Initials': 'D', 'LastName': 'Hua', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Overseas Chinese Hospital, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China. Electronic address: chenrc@vip.163.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106126']
2665,32911210,Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach.,"BACKGROUND


The purpose of this study is to evaluate the effectiveness of the Mindfulness-based Stress Reduction program applied to a sample of Turkish nursing students.
METHOD


The study was designed as a randomized controlled trial. Program sessions of 90-95 minutes were given twice a week for 12 weeks. The data were collected using the Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale.
RESULTS


A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions. On the Mindfulness Scale, a statistically significant difference was found between the mean pre-test and post-test scores obtained by the experiment and control groups.
CONCLUSION


The results derived from this study suggest that the mindfulness-based stress reduction program is effective in reducing the stress experienced by students during nursing education, increasing their mindfulness, strengthening their coping mechanisms for stress, increasing their use of self-confident and optimistic approaches, and decreasing their use of the helpless approach.",2020,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"['Factors affecti̇ng health-promoti?ng behavi̇ors i̇n nursi̇ng students', 'Turkish nursing students']","['mindfulness-based stress reduction program', 'Mindfulness-based Stress Reduction program']","['Nursing Education Stress Scale, the Mindfulness Scale, and the Stress Management Styles Scale', 'Nursing Education Stress Scale']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0013636', 'cui_str': 'Nursing Education'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]",95.0,0.0107001,A statistically significant difference was found in the mean post-test and mean follow-up scores obtained by the control group and the experimental group on the Nursing Education Stress Scale and its sub-dimensions.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Yıldırım Şişman', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: nuriyeyildirim@duzce.edu.tr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karaca', 'Affiliation': 'DuzceUniversity, Facultyof Health Sciences, Department of Nursing, Duzce, Turkey. Electronic address: ayselkaraca@duzce.edu.tr.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cangür', 'Affiliation': 'DuzceUniversity, Faculty of Medicine, Department of Biostatistics and Medical Informatics, Duzce, Turkey. Electronic address: sengulcangur@duzce.edu.tr.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102880']
2666,32911350,Medication adherence and rate of nicotine metabolism are associated with response to treatment with varenicline among smokers with HIV.,"INTRODUCTION


PLWHA who smoke have shown lower cessation rates within placebo-controlled randomized trials of varenicline. Adherence and rate of nicotine metabolism may be associated with quit rates in such clinical trials.
METHODS


This secondary analysis of a randomized placebo-controlled trial of varenicline for smoking among PLWHA (N = 179) examined the relationship between varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation (self-reported 7-day point prevalence abstinence, confirmed with carbon monoxide of ≤ 8 ppm, at the end of treatment; EOT).
RESULTS


Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates. In separate models, adherence (OR = 1.009, 95% CI:1.004-1.01, p < 0.001) and nicotine metabolism rate (OR = 2.04, 95% CI:1.19-3.49, p = 0.009) interacted with treatment arm to effect quit rates. The quit rate for varenicline vs. placebo was higher for both non-adherent (19% vs. 5%; χ 2 [1] = 2.80, p = 0.09) and adherent (35% vs. 15%; χ 2 [1] = 6.51, p = 0.01) participants, but the difference between treatment arms was statistically significant only for adherent participants. Likewise, among slow metabolizers (NMR < 0.31), the varenicline quit rate was not significantly higher vs. placebo (14% vs. 5%; χ 2 [1] = 1.17, p = 0.28) but, among fast metabolizers (NMR ≥ 0.31), the quit rate for varenicline was significantly higher vs. placebo (33% vs. 14%; χ 2 [1] = 4.43, p = 0.04).
CONCLUSIONS


Increasing varenicline adherence and ensuring that fast nicotine metabolizers receive varenicline may increase quit rates for PLWHA.",2020,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.",['smokers with HIV'],"['varenicline and placebo', 'varenicline', 'varenicline vs. placebo', 'varenicline adherence (pill count, ≥80% of pills), nicotine metabolism (based on the nicotine metabolite ratio; NMR) and end-of-treatment smoking cessation', 'placebo']","['nicotine metabolism rate', 'varenicline quit rate', 'quit rate for varenicline', 'quit rate', 'Medication adherence and rate of nicotine metabolism', 'faster nicotine metabolism']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1095963', 'cui_str': 'Smoking cessation therapy'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",179.0,0.482863,"Combining varenicline and placebo arms, greater adherence (OR = 1.011, 95% CI:1.00-1.02, p = 0.051) and faster nicotine metabolism (OR = 3.08, 95% CI:1.01-9.37, p = 0.047) were related to higher quit rates.","[{'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Su Fen', 'Initials': 'SF', 'LastName': 'Lubitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank T', 'Initials': 'FT', 'LastName': 'Leone', 'Affiliation': 'Department of Medicine/Division of Pulmonary, Allergy, & Critical Care, University of Pennsylvania, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Pennsylvania, United States; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hitsman', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry and Abramson Cancer Center, University of Pennsylvania, United States. Electronic address: schnoll@pennmedicine.upenn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106638']
2667,32905591,"Sleep Duration Regularity, But Not Sleep Duration, is Associated with Microvascular Function in College Students.","STUDY OBJECTIVES


Vascular dysfunction is a hypothesized mechanism linking poor sleep habits to an increased incidence of cardiovascular diseases. However, the vascular profile associated with free-living sleep duration and sleep regularity has not been well elucidated, particularly in young adults. Thus, this study aimed to evaluate the associations between mean sleep duration, regularity in sleep duration, and peripheral vascular function in young adult college students.
METHODS


Fifty-one healthy undergraduate students (20±1 years) completed 14 days of 24-hour wrist actigraphy and subsequent vascular assessments. Macrovascular function was measured using brachial artery flow-mediated dilation (FMD) while microvascular function was measured via passive leg movement (PLM).
RESULTS


Mean sleep duration was unrelated to FMD and PLM. Conversely, more irregular sleep duration (14-day sleep duration standard deviation [SD]) was unfavorably associated with all three measures of PLM-induced hyperemia (peak leg blood flow [LBF], p=0.01; change in LBF from baseline to peak, p<0.01; LBF area under the curve, p<0.01), and remained significant in regression models which adjusted for sex, body mass index, blood pressure, physical activity, alcohol and caffeine consumption, and sleep duration (all p<0.05). When using a median split to dichotomize ""low"" and ""high"" sleep duration SD groups, those demonstrating high variability in sleep duration exhibited ~45% lower PLM responses compared to those demonstrating low variability.
CONCLUSIONS


Irregular sleep duration is associated with poorer microvascular function as early as young adulthood. These findings support the growing body of evidence that irregular sleep patterns may be an independent and modifiable risk factor for cardiovascular disease.",2020,Mean sleep duration was unrelated to FMD and PLM.,"['Fifty-one healthy undergraduate students (20±1 years) completed 14 days of', 'College Students', 'young adult college students']",['24-hour wrist actigraphy and subsequent vascular assessments'],"['PLM-induced hyperemia (peak leg blood flow [LBF', 'sex, body mass index, blood pressure, physical activity, alcohol and caffeine consumption, and sleep duration', 'Macrovascular function', 'Sleep Duration Regularity', 'irregular sleep duration (14-day sleep duration standard deviation [SD', 'Mean sleep duration', 'brachial artery flow-mediated dilation (FMD) while microvascular function', 'mean sleep duration, regularity in sleep duration, and peripheral vascular function']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0439471', 'cui_str': 'lbf - pound-force'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",51.0,0.0283834,Mean sleep duration was unrelated to FMD and PLM.,"[{'ForeName': 'Elissa K', 'Initials': 'EK', 'LastName': 'Hoopes', 'Affiliation': 'Department of Kinesiology and Applied Physiology, College of Health Sciences, University of Delaware, Newark, DE.'}, {'ForeName': 'Felicia R', 'Initials': 'FR', 'LastName': 'Berube', 'Affiliation': 'Department of Kinesiology and Applied Physiology, College of Health Sciences, University of Delaware, Newark, DE.'}, {'ForeName': 'Michele N', 'Initials': 'MN', 'LastName': ""D'Agata"", 'Affiliation': 'Department of Kinesiology and Applied Physiology, College of Health Sciences, University of Delaware, Newark, DE.'}, {'ForeName': 'Freda', 'Initials': 'F', 'LastName': 'Patterson', 'Affiliation': 'Department of Behavioral Health and Nutrition, College of Health Sciences, University of Delaware, Newark, DE.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, College of Health Sciences, University of Delaware, Newark, DE.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, College of Health Sciences, University of Delaware, Newark, DE.'}, {'ForeName': 'Melissa A H', 'Initials': 'MAH', 'LastName': 'Witman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, College of Health Sciences, University of Delaware, Newark, DE.'}]",Sleep,['10.1093/sleep/zsaa175']
2668,32905598,"CORRIGENDUM FOR ""Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial"".",,2020,,['Children With GH Deficiency'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714796', 'cui_str': 'Isolated somatotropin deficiency'}]",[],[],,0.127536,,[],The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa614']
2669,32905611,Effect of tranexamic acid on markers of inflammation in children undergoing craniofacial surgery.,"BACKGROUND


Tranexamic acid (TXA) reduces blood loss and transfusion requirements during craniosynostosis surgery in small children. Possible interaction from TXA on the inflammatory system is unknown.
OBJECTIVE


To evaluate the effect of TXA on a wide range of inflammatory markers in children receiving TXA in a randomized, blinded and placebo controlled study design.
METHODS


Thirty children undergoing craniosynostosis surgery with significant blood loss received TXA (bolus dose of 10 mg kg -1  followed by 8 hours continuous infusion of 3 mg kg -1  h -1  ) or placebo in a randomized, double-blinded study design. Using a new proximity extension assays employing a panel of inflammatory biomarkers samples was used for analysis of blood samples obtained preoperatively, 4h and 24 h after operation.
RESULTS


Ninety-two inflammatory parameters were measured. TXA did not affect any of the measured parameters as compared with placebo. Among 34 of the 92 pro- and antiinflammatory parameters investigated changes were observed between preoperative, 4 h or 24 h respectively, reflecting immune activation during surgical stress.
CONCLUSION


TXA administration in a low-dose regimen including bolus followed by 8h infusion during craniosynostosis surgery did not change any of 92 inflammatory markers as compared with placebo.",2020,"Among 34 of the 92 pro- and antiinflammatory parameters investigated changes were observed between preoperative, 4 h or 24 h respectively, reflecting immune activation during surgical stress.
","['craniosynostosis surgery in small children', 'Thirty children undergoing craniosynostosis surgery with significant blood loss received', 'children undergoing craniofacial surgery', 'children receiving']","['Tranexamic acid (TXA', 'tranexamic acid', 'TXA (bolus dose of 10 mg kg -1  followed by 8 hours continuous infusion of 3 mg kg -1  h -1  ) or placebo', 'placebo', 'TXA']",['blood loss and transfusion requirements'],"[{'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1292429', 'cui_str': '8 hours'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",30.0,0.622561,"Among 34 of the 92 pro- and antiinflammatory parameters investigated changes were observed between preoperative, 4 h or 24 h respectively, reflecting immune activation during surgical stress.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fenger-Eriksen', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Juul', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Krog', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Department of Clinical Biochemistry, Thrombosis and Hemostasis Research Unit, Aarhus University Hospital, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13700']
2670,32905615,Metronidazole and amoxicillin for patients with periodontitis and diabetes mellitus: 5 years secondary analysis of a randomized controlled trial.,"BACKGROUND


The aim of this study was to perform a 5-year follow-up analysis of a previously-published randomized trial (RCT) evaluating the 2-years effects of metronidazole (MTZ) plus amoxicillin (AMX) as adjuncts to scaling and root planing (SRP) in the treatment of periodontitis in type 2 diabetic patients.
METHODS


Volunteers who received periodontal treatment in the aforementioned RCT were selected for clinical and microbiological evaluation. Patients did not receive regular supportive periodontal therapy (SPT) from 2 to 5 years post-treatment.
RESULTS


Of the patients enrolled in the RCT, 43% entered this study (n = 10/control and 15/test group). Most of clinical parameter values, including the number of sites with PD≥5mm (primary outcome variable), were reduced at 5 years post-therapy when compared with baseline in the antibiotic-treated group (P < 0.05), but presented higher values than those at 2 years (P < 0.05). The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05).
CONCLUSION


Diabetic patients treated with adjunctive MTZ+AMX were better maintained over a period of 5 years than those treated with SRP only. However, the clinical and microbiological benefits obtained up to 2 years post-treatment were not fully sustained in these patients who did not receive SPT between 2 and 5 years post-treatment. This article is protected by copyright. All rights reserved.",2020,"The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05).
","['patients with periodontitis and diabetes mellitus', 'Diabetic patients treated with', 'Volunteers who received periodontal treatment in the aforementioned RCT were selected for clinical and microbiological evaluation', 'periodontitis in type 2 diabetic patients']","['adjunctive MTZ+AMX', 'regular supportive periodontal therapy (SPT', 'Metronidazole and amoxicillin', 'metronidazole (MTZ) plus amoxicillin (AMX', 'root planing (SRP', 'RCT']",['mean proportions of microbial complexes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}]",,0.0568194,"The mean proportions of microbial complexes did not differ between MTZ+AMX+SRP and SRP-only groups at 5 years post-treatment (P > 0.05).
","[{'ForeName': 'Daniele Ferreira', 'Initials': 'DF', 'LastName': 'da Cruz', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Poliana Mendes', 'Initials': 'PM', 'LastName': 'Duarte', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Luciene Cristina', 'Initials': 'LC', 'LastName': 'de Figueiredo', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Hélio Doyle Pereira', 'Initials': 'HDP', 'LastName': 'da Silva', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Retamal-Valdes', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Feres', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}, {'ForeName': 'Tamires Szeremeske', 'Initials': 'TS', 'LastName': 'Miranda', 'Affiliation': 'Department of Periodontology, Dental Research Division, Guarulhos University, São Paulo, Brazil.'}]",Journal of periodontology,['10.1002/JPER.20-0196']
2671,32912959,Correction: Study protocol for the POPART study - Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial.,,2020,,['Preterm infants'],['Prophylactic Oropharyngeal surfactant'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]",[],,0.185543,,[],BMJ open,['10.1136/bmjopen-2019-035994corr1']
2672,32912971,Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial.,"OBJECTIVE


To evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.
DESIGN AND SETTING


A randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015-August 2016).
PARTICIPANTS


Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.
INTERVENTION


Women were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery.
OUTCOME MEASURES


The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.
RESULTS


325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.
CONCLUSIONS


A large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation.
TRIAL REGISTRATION NUMBER


ISRCTN46661996.",2020,"No serious adverse events were attributable to oestrogen use.
","['325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible', 'Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment', 'six UK urogynaecology centres (July 2015-August 2016', 'women undergoing pelvic organ prolapse (POP) surgery', 'postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS']","['Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries', 'oestrogen treatment with no oestrogen supplementation', 'local oestrogen treatment', 'preoperative and postoperative oestrogen or no treatment']","['complete questionnaires', 'eligibility and recruitment rates along with compliance and data completion', 'serious adverse events']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0330839', 'cui_str': 'Lotus'}]","[{'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",325.0,0.223352,"No serious adverse events were attributable to oestrogen use.
","[{'ForeName': 'Tina Sara', 'Initials': 'TS', 'LastName': 'Verghese', 'Affiliation': 'Institute of Metabolism and System Research, University of Birmingham, Birmingham, UK t.s.verghese@bham.ac.uk.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Middleton', 'Affiliation': 'School of Health and Population Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Leighton', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Pallavi Manish', 'Initials': 'PM', 'LastName': 'Latthe', 'Affiliation': ""Obstetrics and Gynaecology, Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025141']
2673,32912974,Protocol for the economic evaluation of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression.,"INTRODUCTION


Cardiac rehabilitation (CR) is offered to reduce the risk of further cardiac events and to improve patients' health and quality of life following a cardiac event. Psychological care is a common component of CR as symptoms of depression and/or anxiety are more prevalent in this population, however evidence for the cost-effectiveness of current interventions is limited. Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients. This protocol describes the planned approach to the economic evaluation of MCT for CR patients.
METHODS AND ANALYSIS


The economic evaluation work will consist of a within-trial analysis and an economic model. The PATHWAY Group MCT study has been prospectively designed to collect comprehensive self-reported resource use and health outcome data, including the EQ-5D, within a randomised controlled trial study design (UK Clinical Trials Gateway). A within-trial economic evaluation and economic model will compare the cost-effectiveness of MCT plus usual care (UC) to UC, from a health and social care perspective in the UK. The within-trial analysis will use intention-to-treat and estimate total costs and quality-adjusted life-years (QALYs) for the trial follow-up. Single imputation will be used to impute missing baseline variables. Multiple imputation will be used to impute values missing at follow-up. Items of resource use will be multiplied by published national healthcare costs. Regression analysis will be used to estimate net costs and net QALYs and these estimates will be bootstrapped to generate 10 000 net pairs of costs and QALYs to inform the probability of cost-effectiveness. A decision analytical economic model will be developed to synthesise trial data with the published literature over a longer time frame. Sensitivity analysis will explore uncertainty. Guidance of the methods for economic models will be followed and dissemination will adhere to reporting guidelines.
ETHICS AND DISSEMINATION


The economic evaluation includes a within-trial analysis. The trial which included the collection of this data was reviewed and approved by Ethics. Ethics approval was obtained by the Preston Research Ethics Committee (project ID 156862). The modelling analysis is not applicable for Ethics as it will use data from the trial (secondary analysis) and the published literature. Results of the main trial and economic evaluation will be published in the peer-reviewed National Institute for Health Research (NIHR) journals library (Programme Grants for Applied Research), submitted to a peer-reviewed journal and presented at appropriate conferences.
TRIAL REGISTRATION NUMBER


ISRCTN74643496; Pre-results.",2020,"Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients.",['cardiac rehabilitation participants with symptoms of anxiety and/or depression'],"['MCT plus usual care (UC) to UC', 'Metacognitive therapy (MCT', 'metacognitive therapy', 'Cardiac rehabilitation (CR']",['total costs and quality-adjusted life-years (QALYs'],"[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.156245,"Metacognitive therapy (MCT), is a recent treatment development that is effective in treating anxiety and depression in mental health settings and is being evaluated in CR patients.","[{'ForeName': 'Gemma E', 'Initials': 'GE', 'LastName': 'Shields', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK gemma.shields@manchester.ac.uk.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'Faculty of Biology, Medicine and Health, School of Psychological Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Doherty', 'Affiliation': 'Department of Health Sciences, University of York, York, North Yorkshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'Centre for Primary Care, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Capobianco', 'Affiliation': 'Research & Innovation, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Heagerty', 'Affiliation': 'Institute of Cardiovascular Sciences, The University of Manchester, Manchester, Manchester, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Buck', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Davies', 'Affiliation': 'Manchester Centre for Health Economics, The University of Manchester, Manchester, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035552']
2674,32912977,Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study.,"INTRODUCTION


Major depression (MD) often has its onset during adolescence and is associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation and the underlying neural processes. Cognitive reappraisal (CR) is a particular adaptive emotion regulation strategy. Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.This randomised controlled trial examines for the first time whether a task-based training in CR proves effective in MD adolescents. Specifically, we will investigate whether the CR training improves the ability to downregulate negative affect in MD individuals as assessed by behavioural and neurobiological indices, and whether training effects generalise outside the laboratory.
METHODS AND ANALYSIS


Adolescents with MD will be randomly allocated to a group that either receives a task-based training in CR or a control training. Both involve four training sessions over a time period of 2 weeks. In the CR training, participants will be instructed to downregulate negative affective responses to negative pictures via CR, while the control training involves picture viewing. During the training sessions, the Late Positive Potential, gaze fixations on negative picture aspects and affective responses to pictures will be collected. Before and after the training programmes, and at a 2-week follow-up, overall negative and positive affect, rumination and perceived stress will be assessed as primary outcomes. Analyses of variance will be conducted to test the effectiveness of the CR training with regard to both primary outcomes and task-based behavioural and neurobiological parameters.
ETHICS AND DISSEMINATION


The study was approved by the Ethics Committee of the Medical Faculty of the LMU Munich, Germany. The results will be published in peer-reviewed journals and disseminated through conferences, social media and public events.
TRIAL REGISTRATION DETAILS


ClinicalTrials.gov NCT03957850, registered 21 st  May 2019; URL: https://clinicaltrials.gov/ct2/show/NCT03957850.",2020,"Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.","['Adolescents with MD', 'adolescents with major depression', 'registered 21 st  May 2019', 'MD adolescents', 'healthy adults']","['Cognitive reappraisal (CR', 'emotion regulation training', 'CR training', 'task-based training in CR', 'task-based training in CR or a control training']","['Late Positive Potential, gaze fixations on negative picture aspects and affective responses']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]",,0.0982554,"Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany Ellen.Greimel@med.uni-muenchen.de.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Feldmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Piechaczek', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Oort', 'Affiliation': 'Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Bartling', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schulte-Rüther', 'Affiliation': 'Translational Brain Medicine in Psychiatry and Neurology, Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Schulte-Körne', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-036093']
2675,32912978,Risperidone versus placebo for aggression following traumatic brain injury: a feasibility randomised controlled trial.,"OBJECTIVES


To conduct a feasibility randomised controlled trial of risperidone for the treatment of aggression in adults with traumatic brain injury (TBI).
DESIGN


Multicentre, parallel design, placebo controlled (1:1 ratio) double-blind feasibility trial with an embedded process evaluation. No statistical comparison was performed between the two study groups.
SETTING


Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK.
PARTICIPANTS


Our aim was to recruit 50 patients with TBI over 18 months. Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
RESULTS


Six participants were randomised to the active arm of the trial and eight to the placebo arm over a 10-month period (28% of our target). Two participants withdrew because of adverse events. Twelve out of 14 (85.7%) patients completed a follow-up assessment at 12 weeks. At follow-up, the scores of all outcome measures improved in both groups. Placebo group showed numerically better score change according to the primary outcome MOAS. No severe adverse events were reported. The overall rate of adverse events remained low. Data from the process evaluation suggest that existence of specialised TBI follow-up clinics, availability of a dedicated database of TBI patients' clinical details, simple study procedures and regular support to participants would enhance recruitment and retention in the trial. Feedback from participants showed that once in the study, they did not find the trial procedure onerous.
CONCLUSIONS


It was not feasible to conduct a successful randomised trial of risperidone versus placebo for post-TBI aggression using the methods we deployed in this study. It is not possible to draw any definitive conclusion about risperidone's efficacy from such a small trial.
TRIAL REGISTRATION NUMBER


ISRCTN30191436.",2020,"Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
","['50 patients with TBI over 18 months', 'adults with traumatic brain injury (TBI', 'Four neuropsychiatric and neurology outpatient clinics in London and Kent, UK', 'Six participants', 'traumatic brain injury']","['placebo', 'Risperidone', 'risperidone', 'risperidone versus placebo', 'Placebo']","['severe adverse events', 'aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser', 'overall rate of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0454861', 'cui_str': 'Kent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.665328,"Follow-up participants at 12 weeks using a battery of assessment scales to measure changes in aggressive behaviour and irritability (Modified Overt Aggression Scale (MOAS)-primary outcome, Irritability Questionnaire) as well as global functioning (Glasgow Outcome Scale-Extended, Clinical Global impression) and quality of life (EQ-5D-5L, SF-12), mental health (Hospital Anxiety and Depression Scale) and medication adverse effects (Udvalg for Kliniske Undersøgelser).
","[{'ForeName': 'Shoumitro', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK s.deb@imperial.ac.uk.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aimola', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Verity', 'Initials': 'V', 'LastName': 'Leeson', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Mayur', 'Initials': 'M', 'LastName': 'Bodani', 'Affiliation': 'Kent and Medway NHS and Social Care Partnership NHS Trust, Maidstone, UK.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Weaver', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sharp', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd, London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Department of Brain Sciences, Faculty of Medicine, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036300']
2676,32913174,Does preoperative chemical depilation make any difference in postoperative wound infection?,"Background


Preparation for surgery has traditionally included the removal of body hair from the intended surgical wound site. The effect of this practice on postoperative wound infection is yet to be fully elucidated.
Aims


This study sought to determine if preoperative chemical depilation reduces the risk of surgical site infection (SSI).
Methodology


Two methods of preoperative hair removal: razor shaving and depilatory cream were compared. The eligible patients were randomized into two groups and the presence of postoperative wound infection was evaluated using the Southampton wound grading system. Data were analyzed using SPSS version 21 Chicago-Illinois, statistical significance was inferred at Pvalue ≤ 0.05.
Results


In total 100 patients were analyzed with 20 patients excluded due to co-morbidities and noncompletion of the study. The overall prevalence of SSI was 18.0% (7 (14.0%) and 11 (22.0%) in the depilatory cream and razor shaving groups, respectively). The difference in the rate of SSI was not statistically significant (P = 0.436). Hair was completely removed in 47 (94.0%) compared to 38 (76.0%) patients in the razor shaving group (P = 0.012) while skin injuries were noted in 21 (42.0%) vs 1 (2.0%) patients who had razor shaving and chemical depilation(P = <0.0001), respectively.
Conclusion


There was no significant difference in SSI rates in patients that had preoperative chemical depilation when compared with razor shaving.",2020,There was no significant difference in SSI rates in patients that had preoperative chemical depilation when compared with razor shaving.,['In total 100 patients were analyzed with 20 patients excluded due to co-morbidities and noncompletion of the study'],['preoperative hair removal: razor shaving and depilatory cream'],"['Hair', 'overall prevalence of SSI', 'SSI rates', 'skin injuries', 'rate of SSI']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018504', 'cui_str': 'Epilation'}, {'cui': 'C0336670', 'cui_str': 'Razor'}, {'cui': 'C0518505', 'cui_str': 'Does shave'}, {'cui': 'C0304647', 'cui_str': 'Depilatory agent'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0281980', 'cui_str': 'Injury of integument'}]",100.0,0.0982687,There was no significant difference in SSI rates in patients that had preoperative chemical depilation when compared with razor shaving.,"[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Okoli', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Anyanwu', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Emegoakor', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'G U', 'Initials': 'GU', 'LastName': 'Chianakwana', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ihekwoaba', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ughasoro', 'Affiliation': 'Department of Pediatrics, University of Nigeria Enugu Campus, Enugu, Nigeria.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Egwuonwu', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nzeako', 'Affiliation': 'Department of Surgery, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_149_20']
2677,32913210,Combined use of transversus abdominis plane block and laryngeal mask airway during implementing ERAS programs for patients with primary liver cancer: a randomized controlled trial.,"The incidence and mortality of primary liver cancer are very high and resection of tumor is the most crucial treatment for it. We aimed to assess the efficacy and safety of combined use of transversus abdominis plane (TAP) block and laryngeal mask airway (LMA) during implementing Enhanced Recovery After Surgery (ERAS) programs for patients with primary liver cancer. This was a prospective, evaluator-blinded, randomized, controlled parallel-arm trial. A total of 96 patients were enrolled (48 in each group). Patients in the control group received general anesthesia with endotracheal intubation, while patients in the TAP + LMA group received general anesthesia with LMA and an ultrasound-guided subcostal TAP block. The primary end-point was postoperative time of readiness for discharge. The secondary end-points were postoperative pain intensity, time to first flatus, quality of recovery (QoR), complications and overall medical cost. Postoperative time of readiness for discharge in the TAP + LMA group [7 (5-11) days] was shorter than that of the control group [8 (5-13) days, P = 0.004]. The postoperative apioid requirement and time to first flatus was lower in the TAP + LMA group [(102.8 ± 12.4) µg, (32.7 ± 5.8) h, respectively] than the control group [(135.7 ± 20.1) µg, P = 0.000; (47.2 ± 7.6) h, P = 0.000; respectively]. The QoR scores were significantly higher in the TAP + LMA group than the control group. The total cost for treatment in the TAP + LMA group [(66,608.4 ± 6,268.4) CNY] was lower than that of the control group [(84,434.0 ± 9,436.2) CNY, P = 0.000]. There was no difference in complications between these two groups. The combined usage of a TAP block and LMA is a simple, safe anesthesia method during implementing ERAS programs for patients with primary liver cancer. It can alleviate surgical stress, accelerate recovery and reduce medical cost.",2020,There was no difference in complications between these two groups.,"['96 patients were enrolled (48 in each group', 'patients with primary liver cancer']","['TAP\u2009+\u2009LMA group received general anesthesia with LMA and an ultrasound-guided subcostal TAP block', 'general anesthesia with endotracheal intubation', 'Surgery (ERAS) programs', 'transversus abdominis plane block and laryngeal mask airway during implementing ERAS programs', 'TAP block and LMA', 'transversus abdominis plane (TAP) block and laryngeal mask airway (LMA', 'TAP\u2009+\u2009LMA']","['postoperative pain intensity, time to first flatus, quality of recovery (QoR), complications and overall medical cost', 'efficacy and safety', 'total cost', 'Postoperative time of readiness for discharge', 'postoperative time of readiness for discharge', 'postoperative apioid requirement and time to first flatus', 'complications', 'QoR scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024620', 'cui_str': 'Primary malignant neoplasm of liver'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442184', 'cui_str': 'Subcostal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0478321,There was no difference in complications between these two groups.,"[{'ForeName': 'Hai-Ming', 'Initials': 'HM', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Rui-Xia', 'Initials': 'RX', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Lin-Mei', 'Initials': 'LM', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, Guangdong Clifford Hospital, Guangzhou, 511495, Guangdong, China.'}, {'ForeName': 'Wen-Shuai', 'Initials': 'WS', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Xi-Jiu', 'Initials': 'XJ', 'LastName': 'Ye', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Fu-Ding', 'Initials': 'FD', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliopancreatic Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, NO. 107, Yanjiangxi Road, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Xue-Ying', 'Initials': 'XY', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Anesthesiology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, Guangdong, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Hepatobiliopancreatic Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, NO. 107, Yanjiangxi Road, Guangzhou, 510120, Guangdong, China. 307423373@qq.com.'}]",Scientific reports,['10.1038/s41598-020-71477-x']
2678,32913368,Correction: Phage Display of the Serpin Alpha-1 Proteinase Inhibitor Randomized at Consecutive Residues in the Reactive Centre Loop and Biopanned with or without Thrombin.,[This corrects the article DOI: 10.1371/journal.pone.0084491.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0084491.].,[],[],[],[],[],[],,0.0271319,[This corrects the article DOI: 10.1371/journal.pone.0084491.].,"[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scott', 'Affiliation': ''}, {'ForeName': 'Wadim L', 'Initials': 'WL', 'LastName': 'Matochko', 'Affiliation': ''}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Gierczak', 'Affiliation': ''}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Bhakta', 'Affiliation': ''}, {'ForeName': 'Ratmir', 'Initials': 'R', 'LastName': 'Derda', 'Affiliation': ''}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Sheffield', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238969']
2679,32913399,"A randomized, double-blind, placebo-controlled pilot study to assess the effects of protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract on the prevention of acute respiratory illness in healthy people.","Background


GS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial.
Methods


This study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms.
Results


The rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively.
Conclusion


The results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.",2020,"The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively.","['healthy people', '45 healthy applicants', 'single center from October 2014 to March 2015']","['protopanaxadiol saponin-enriched ginseng extract and pectinase-processed ginseng extract', 'GS-3K8', 'GINST', 'GS-3K8 and GINST', 'placebo groups', 'placebo']","['incidence of ARI', 'rate of recruitment', 'duration of symptoms', 'overall rate', 'mean compliance rate', 'rates of recruitment, drug compliance, and successful follow-up', 'acute respiratory illness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0072494', 'cui_str': 'protopanaxadiol'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C0032491', 'cui_str': 'Polygalacturonase'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.549673,"The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively.","[{'ForeName': 'Jeong-Hwan', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Eun-Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Jung', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Pyo', 'Affiliation': 'International Ginseng and Herb Research Institute, Geumsan, Republic of Korea.'}, {'ForeName': 'Soo-Wan', 'Initials': 'SW', 'LastName': 'Chae', 'Affiliation': 'Clinical Trial Center for Functional Foods, Jeonbuk National University Hospital, Jeonju, Jeonbuk, Republic of Korea.'}]",Journal of ginseng research,['10.1016/j.jgr.2019.01.002']
2680,32913443,An open-label randomised pilot trial on safety of wheat variety C273 in patients with adult celiac disease.,"Background


The only effective treatment for celiac disease (CeD) is gluten free diet (GFD). However, GFD is restrictive and efforts are being made to explore alternative therapies including safer wheat varieties. Wheat variety C273 has been previously identified to have reduced load of intact T-cell stimulatory epitopes  via in silico  and  in vitro  analysis.
Methods


Adult patients diagnosed with CeD and recovered on GFD were included in the study. Patients were randomised into two groups in a 2:1 ratio. Patients in group I had graded introduction of C273 wheat in diet, maintained for 24 weeks; in Group II, wheat was restricted with continuation of GFD. Clinical symptoms, serology [anti-tissue transglutaminase (anti-tTG), anti-endomysial antibody (anti-EMA)], circulating inflammatory biomarkers [intestinal fatty-acid binding protein (I-FABP), plasma citrulline, interferon-γ (IFN-γ)] and histology were evaluated periodically. Final evaluation was performed at week 28.
Results


A total of 15 patients were enrolled (Group I:  n  = 10, Group II:  n  = 5). All patients except two in Group I remained compliant. None of the remaining eight patients in group I developed symptoms. No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p  > 0.05). Significant changes in plasma citrulline(29.87 ± 8.98  versus  36.58 ± 3.09,  p  = 0.049) and IFN-γ (44.56 ± 9.74  versus  33.50 ± 3.68;  p  = 0.031) were observed in Group I.
Conclusion


Consumption of C273 wheat did not result in development of symptoms or evident changes in serology and histology at 28 weeks. However, variations in circulating inflammatory markers were noted. Larger randomised trials are needed to corroborate these findings.
Clinical Trials Registry-India


CTRI/2018/06/014521.",2020,"No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p  > 0.05).","['Adult patients diagnosed with CeD and recovered on GFD were included in the study', '15 patients were enrolled', 'patients with adult celiac disease']",['wheat variety C273'],"['serology (anti-tTG, anti-EMA) and histology', 'circulating inflammatory markers', 'IFN-γ', 'symptoms', 'Clinical symptoms, serology [anti-tissue transglutaminase (anti-tTG), anti-endomysial antibody (anti-EMA)], circulating inflammatory biomarkers [intestinal fatty-acid binding protein (I-FABP), plasma citrulline, interferon-γ (IFN-γ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238049', 'cui_str': 'Adult form of celiac disease'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}]","[{'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C0529334', 'cui_str': 'transglutaminase 2'}, {'cui': 'C0443906', 'cui_str': 'Endomysial antibody'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0163314', 'cui_str': 'Intestinal Fatty Acid-Binding Protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}]",15.0,0.0395008,"No significant changes in serology (anti-tTG, anti-EMA) and histology were observed between the two groups at 28 weeks ( p  > 0.05).","[{'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Grover', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Parveen', 'Initials': 'P', 'LastName': 'Chhuneja', 'Affiliation': 'School of Agricultural Biotechnology, Punjab Agricultural University, Ludhiana, Punjab, India.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Midha', 'Affiliation': 'Department of Internal Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Arshdeep', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Ramit', 'Initials': 'R', 'LastName': 'Mahajan', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Mehta', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, India.'}, {'ForeName': 'Ramneek', 'Initials': 'R', 'LastName': 'Verma', 'Affiliation': 'School of Animal Biotechnology, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India.'}, {'ForeName': 'Ekta', 'Initials': 'E', 'LastName': 'Bansal', 'Affiliation': 'Department of Biochemistry, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Dipak', 'Initials': 'D', 'LastName': 'Deka', 'Affiliation': 'School of Animal Biotechnology, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana, Punjab, India.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Statistician, Research and Development Centre, Dayanand Medical College, Ludhiana, Punjab, India.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Sood', 'Affiliation': 'Department of Pathology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Narang', 'Affiliation': 'Department of Pathology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.'}, {'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Department of Gastroenterology, Dayanand Medical College and Hospital, 6-E, Tagore Nagar, Civil Lines, Ludhiana, Punjab 141001, India.'}]",Therapeutic advances in gastroenterology,['10.1177/1756284820944089']
2681,32913576,Effects of Neuromuscular Electrical Stimulation (NMES) on salivary flow in healthy adults.,"Background


Neuromuscular electrical stimulation (NMES) is a method used for enhancing suprahyoid muscle activity and is widely applied as a treatment for dysphagia. Patients often complain of saliva pooling in the pharynx during NMES. Therefore, the purpose of this study was to investigate the changes in salivary flow during NMES.
Material and Methods


Twenty healthy adults participated in this study. Electrical stimulation was applied at constant strength for 60 minutes to the suprahyoid muscles using VitalStim®. Participants were examined under three conditions of NMES: sensory threshold plus 75% of the difference between sensory and pain thresholds (75% Stim), SensoryStim, and Sham. Saliva collections, using a 10-min spitting method, were performed seven times: before stimulation (S1), during stimulation (S2-S6), and 5 min after stimulation ended (S7).
Results


Significant differences were observed in saliva flow between S1 and S7, as well as S2 and S7 in 75% Stim.
Conclusions


This study indicates that an increase in saliva flow was promoted after NMES. Therefore, NMES may have effects on patients with xerostomia.  Key words: Neuromuscular electrical stimulation, suprahyoid muscle, sensory threshold, pain threshold, saliva flow.",2020,"Results


Significant differences were observed in saliva flow between S1 and S7, as well as S2 and S7 in 75% Stim.
","['patients with xerostomia', 'Twenty healthy adults participated in this study', 'healthy adults', 'Patients often complain of saliva pooling in the pharynx during NMES']","['\n\n\nNeuromuscular electrical stimulation (NMES', 'NMES', 'Neuromuscular Electrical Stimulation (NMES']","['Neuromuscular electrical stimulation, suprahyoid muscle, sensory threshold, pain threshold, saliva flow', 'sensory and pain thresholds', 'saliva flow', 'salivary flow']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1744679', 'cui_str': 'Structure of suprahyoid muscle'}, {'cui': 'C0036677', 'cui_str': 'Sensory threshold'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",20.0,0.0515408,"Results


Significant differences were observed in saliva flow between S1 and S7, as well as S2 and S7 in 75% Stim.
","[{'ForeName': 'Joji', 'Initials': 'J', 'LastName': 'Koike', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nozue', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Ihara', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'DDS, PhD. Division of Oral Rehabilitation Medicine, Department of Special Needs Dentistry, School of Dentistry, Showa University, Tokyo, Japan.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56572']
2682,32913638,The impact of community containment implementation timing on the spread of COVID-19: A simulation study.,"Background:  Community containment is one of the common methods used to mitigate infectious disease outbreaks. The effectiveness of such a method depends on how strictly it is applied and the timing of its implementation. An early start and being strict is very effective; however, at the same time, it impacts freedom and economic opportunity. Here we created a simulation model to understand the effect of the starting day of community containment on the final outcome, that is, the number of those infected, hospitalized and those that died, as we followed the dynamics of COVID-19 pandemic.  Methods:  We used a stochastic recursive simulation method to apply disease outbreak dynamics measures of COVID-19 as an example to simulate disease spread. Parameters are allowed to be randomly assigned between higher and lower values obtained from published COVID-19 literature.  Results:  We simulated the dynamics of COVID-19 spread, calculated the number of active infections, hospitalizations and deaths as the outcome of our simulation and compared these results with real world data. We also represented the details of the spread in a network graph structure, and shared the code for the simulation model to be used for examining other variables.  Conclusions:  Early implementation of community containment has a big impact on the final outcome of an outbreak.",2020,"An early start and being strict is very effective; however, at the same time, it impacts freedom and economic opportunity.",['spread of COVID-19'],[],[],"[{'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",[],[],,0.039212,"An early start and being strict is very effective; however, at the same time, it impacts freedom and economic opportunity.","[{'ForeName': 'Attayeb', 'Initials': 'A', 'LastName': 'Mohsen', 'Affiliation': 'Laboratory of Bioinformatics, Artificial Intelligence Center for Health and Biomedical Research (ArCHER). National Institutes of Biomedical Innovation, Health and Nutrition., Ibaraki city, Osaka, 567-0085, Japan.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Alarabi', 'Affiliation': 'Department of Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M University, Kingsville, Texas, 78363, USA.'}]",F1000Research,['10.12688/f1000research.24156.1']
2683,32913645,The impact of intuitive eating  v . pinned eating on behavioural markers: a preliminary investigation.,"Two promising strategies to manage eating behaviour are intuitive eating (IE; following hunger) and pinned eating (PE; ignoring hunger/eating at specific times of the day). This study compared IE and PE on behavioural markers. Participants ( n  56) were randomly assigned to IE ( n  28) or PE ( n  28) and given instructions to follow for 1 week. Drive to eat, behaviour, behavioural intentions and self-efficacy were measured at baseline and follow-up. Participants also evaluated their specific intervention. Comparable changes over time were found for both conditions for many measures. Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss: those following IE showed an increase in each of these outcomes compared to those following PE who showed no change. The IE group found their intervention more useful than those following PE. Further research is needed to build on these preliminary findings.",2020,"Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss:",['Participants ( n  56'],"['PE', 'intuitive eating  v . pinned eating']","['behavioural markers', 'healthy snacking, total self-efficacy and self-efficacy for weight loss', 'Drive to eat, behaviour, behavioural intentions and self-efficacy']",[],"[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",56.0,0.0331015,"Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss:","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Ogden', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pavlova', 'Affiliation': 'School of Nutrition, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Fouracre', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lammyman', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}]",Journal of nutritional science,['10.1017/jns.2020.25']
2684,32905673,High-Flow Oxygen with Capping or Suctioning for Tracheostomy Decannulation.,"BACKGROUND


When patients with a tracheostomy tube reach a stage in their care at which decannulation appears to be possible, it is common practice to cap the tracheostomy tube for 24 hours to see whether they can breathe on their own. Whether this approach to establishing patient readiness for decannulation leads to better outcomes than one based on the frequency of airway suctioning is unclear.
METHODS


In five intensive care units (ICUs), we enrolled conscious, critically ill adults who had a tracheostomy tube; patients were eligible after weaning from mechanical ventilation. In this unblinded trial, patients were randomly assigned either to undergo a 24-hour capping trial plus intermittent high-flow oxygen therapy (control group) or to receive continuous high-flow oxygen therapy with frequency of suctioning being the indicator of readiness for decannulation (intervention group). The primary outcome was the time to decannulation, compared by means of the log-rank test. Secondary outcomes included decannulation failure, weaning failure, respiratory infections, sepsis, multiorgan failure, durations of stay in the ICU and hospital, and deaths in the ICU and hospital.
RESULTS


The trial included 330 patients; the mean (±SD) age of the patients was 58.3±15.1 years, and 68.2% of the patients were men. A total of 161 patients were assigned to the control group and 169 to the intervention group. The time to decannulation was shorter in the intervention group than in the control group (median, 6 days [interquartile range, 5 to 7] vs. 13 days [interquartile range, 11 to 14]; absolute difference, 7 days [95% confidence interval, 5 to 9]). The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group. Other secondary outcomes were similar in the two groups.
CONCLUSIONS


Basing the decision to decannulate on suctioning frequency plus continuous high-flow oxygen therapy rather than on 24-hour capping trials plus intermittent high-flow oxygen therapy reduced the time to decannulation, with no evidence of a between-group difference in the incidence of decannulation failure. (REDECAP ClinicalTrials.gov number, NCT02512744.).",2020,"The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group.","['161 patients were assigned to the control group and 169 to the intervention group', '330 patients; the mean (±SD) age of the patients was 58.3±15.1 years, and 68.2% of the patients were men', 'critically ill adults who had a tracheostomy tube; patients were eligible after weaning from mechanical ventilation']","['High-Flow Oxygen with Capping or Suctioning', '24-hour capping trial plus intermittent high-flow oxygen therapy (control group) or to receive continuous high-flow oxygen therapy with frequency of suctioning being the indicator of readiness for decannulation (intervention group']","['decannulation failure, weaning failure, respiratory infections, sepsis, multiorgan failure, durations of stay in the ICU and hospital, and deaths in the ICU and hospital', 'duration of stay', 'time to decannulation', 'incidence of decannulation failure', 'incidence of pneumonia and tracheobronchitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184159', 'cui_str': 'Tracheostomy tube'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0376249', 'cui_str': 'Frequency'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0178148', 'cui_str': 'Removal of tracheostomy tube'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0178148', 'cui_str': 'Removal of tracheostomy tube'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1868713', 'cui_str': 'Weaning failure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0040586', 'cui_str': 'Tracheobronchitis'}]",330.0,0.138735,"The incidence of pneumonia and tracheobronchitis was lower, and the duration of stay in the hospital shorter, in the intervention group than in the control group.","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Hernández Martínez', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Maria-Luisa', 'Initials': 'ML', 'LastName': 'Rodriguez', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Maria-Concepción', 'Initials': 'MC', 'LastName': 'Vaquero', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Ortiz', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Joan-Ramon', 'Initials': 'JR', 'LastName': 'Masclans', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Roca', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Colinas', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'de Pablo', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Maria-Del-Carmen', 'Initials': 'MD', 'LastName': 'Espinosa', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Garcia-de-Acilu', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Climent', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Cuena-Boy', 'Affiliation': ""From Virgen de la Salud University Hospital (G.H.M., M.-L.R., L.C.) and the Research Unit, Medical Council (R.C.-B.), Toledo, Ramón y Cajal University Hospital (M.-C.V., R.P.) and Ciber Enfermedades Respiratorias, Health Institute Carlos III (O.R.), Madrid, Ciudad Real University Hospital and Ciudad Real University, Ciudad Real (R.O., M.-C.E.), Medical Research Mar Institute (J.-R.M.), the Critical Care Department, Autònoma de Barcelona University (J.-R.M., M.G.-A.), Del Mar University Hospital (J.-R.M., C.C.), Vall d'Hebron Research Institute (O.R.), and Vall d'Hebron University Hospital (O.R., M.G.A.), Barcelona, and Alcala University, Alcalá de Henares (R.P.) - all in Spain.""}]",The New England journal of medicine,['10.1056/NEJMoa2010834']
2685,32905674,BIVV001 Fusion Protein as Factor VIII Replacement Therapy for Hemophilia A.,"BACKGROUND


Factor VIII replacement products have improved the care of patients with hemophilia A, but the short half-life of these products affects the patients' quality of life. The half-life of recombinant factor VIII ranges from 15 to 19 hours because of the von Willebrand factor chaperone effect. BIVV001 (rFVIIIFc-VWF-XTEN) is a novel fusion protein designed to overcome this half-life ceiling and maintain high sustained factor VIII activity levels. Data are lacking on the safety and pharmacokinetics of single-dose BIVV001.
METHODS


In this phase 1-2a open-label trial, we consecutively assigned 16 previously treated men (18 to 65 years of age) with severe hemophilia A (factor VIII activity, <1%) to receive a single intravenous injection of recombinant factor VIII at a dose of 25 IU per kilogram of body weight (lower-dose group) or 65 IU per kilogram (higher-dose group). This injection was followed by a washout period of at least 3 days. The patients then received a single intravenous injection of BIVV001 at the same corresponding dose of either 25 IU or 65 IU per kilogram. Adverse events and pharmacokinetic measurements were assessed.
RESULTS


No inhibitors to factor VIII were detected and no hypersensitivity or anaphylaxis events were reported up to 28 days after the injection of single-dose BIVV001. The geometric mean half-life of BIVV001 was three to four times as long as that of recombinant factor VIII (37.6 hours vs. 9.1 hours in the lower-dose group and 42.5 vs. 13.2 hours in the higher-dose group); the area under the curve (AUC) for product exposure was six to seven times as great in the two dose groups (4470 hours vs. 638 hours × IU per deciliter in the lower-dose group and 12,800 hours vs. 1960 hours × IU per deciliter in the higher-dose group). After the injection of BIVV001 in the higher-dose group, the mean factor VIII level was in the normal range (≥51%) for 4 days and 17% at day 7, which suggested the possibility of a weekly interval between treatments.
CONCLUSIONS


In a small, early-phase study involving men with severe hemophilia A, a single intravenous injection of BIVV001 resulted in high sustained factor VIII activity levels, with a half-life that was up to four times the half-life associated with recombinant factor VIII, an increase that could signal a new class of factor VIII replacement therapy with a weekly treatment interval. No safety concerns were reported during the 28-day period after administration. (Funded by Sanofi and Sobi; ClinicalTrials.gov number, NCT03205163.).",2020,No inhibitors to factor VIII were detected and no hypersensitivity or anaphylaxis events were reported up to 28 days after the injection of single-dose BIVV001.,"['Hemophilia A', 'men with severe hemophilia A', '16 previously treated men (18 to 65 years of age) with severe hemophilia A (factor VIII activity, <1']",['recombinant factor VIII'],"['Adverse events and pharmacokinetic measurements', 'mean factor VIII level', 'hypersensitivity or anaphylaxis events', 'sustained factor VIII activity levels']","[{'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0795577', 'cui_str': 'recombinant antihemophilic factor VIII'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0200399', 'cui_str': 'Factor VIII assay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",16.0,0.0608014,No inhibitors to factor VIII were detected and no hypersensitivity or anaphylaxis events were reported up to 28 days after the injection of single-dose BIVV001.,"[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Konkle', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'Shapiro', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Doris V', 'Initials': 'DV', 'LastName': 'Quon', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Staber', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Kulkarni', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Margaret V', 'Initials': 'MV', 'LastName': 'Ragni', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Ekta S', 'Initials': 'ES', 'LastName': 'Chhabra', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Poloskey', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Rice', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Katragadda', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Fruebis', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Benson', 'Affiliation': 'From Bloodworks Northwest and the University of Washington, Seattle (B.A.K.); Indiana Hemophilia and Thrombosis Center, Indianapolis (A.D.S.); the Orthopaedic Hemophilia Treatment Center, Los Angeles (D.V.Q.); the University of Iowa, Iowa City (J.M.S.); Michigan State University, East Lansing (R.K.); the Department of Medicine, University of Pittsburgh, and the Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.); and Sanofi (E.S.C., S.P., S.K., C.C.B.) and Bioverativ (K.R., J.F.) - both in Waltham, MA.'}]",The New England journal of medicine,['10.1056/NEJMoa2002699']
2686,32905977,A preliminary study on the application of DTI in the treatment of brain tumors in motor function areas with gamma knife.,"OBJECTIVES


The treatment safety and efficiency as well as the life quality of patients are still main concerns in gamma knife radiosurgery. In this study, the feasibility of applying diffusion tensor imaging (DTI) in gamma knife radiosurgery for the treatment of brain tumor in motor function areas was investigated, which aims to provide protection on the pyramidal tract and preserve the motor function in patients.
PATIENTS AND METHODS


Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group. The tumor control rate was assessed at 3 months after surgery. The muscle strength of affected limb, KPS scores, ZEW scores and complications were evaluated at 3 and 6 months after gamma knife radiosurgery.
RESULTS


Our results indicated that the tumor control rate, complication rate, the muscle strength of affected limb and KPS scores were not significantly different between the two groups at 3 months after surgery. At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group. Furthermore, the stability of muscle strength in patients with limb dysfunction was significantly improved in DTI group (86.4 % vs 50 %, P = 0.028).
CONCLUSION


In summary, the application of DTI in gamma knife radiosurgery for the treatment of brain tumors in motor function areas can precisely define the tumor edge from pyramidal tract, which will support on designing individual treatment plan, reducing the incidence of complications, and improving long-term life quality in patients.",2020,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","['Total 74 patients with solid brain tumor were enrolled and divided into DTI group and control group', 'patients', 'brain tumors in motor function areas with gamma knife']","['DTI', 'diffusion tensor imaging (DTI', 'gamma knife radiosurgery']","['tumor control rate', 'ZEW scores', 'limb dysfunction', 'tumor control rate, complication rate, the muscle strength of affected limb and KPS scores', 'complication rate', 'KPS scores', 'muscle strength of affected limb, KPS scores, ZEW scores and complications', 'stability of muscle strength']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0086330', 'cui_str': 'Radiosurgery, Gamma Knife'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",74.0,0.018093,"At 6 months after gamma knife radiosurgery, the complication rate (0% vs 50 %, P = 0.044), KPS scores (64.9 % vs 37.8 %, P = 0.036) and ZEW scores (78.4 % vs 54.1 %, P = 0.044) of DTI group were better than the control group.","[{'ForeName': 'Yadi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China. Electronic address: hongweiwangimmu@yahoo.com.'}, {'ForeName': 'Zhanbiao', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Magnetic Resonance Imaging, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nuclear Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Guorong', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Gamma Knife Center, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, PR China.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106169']
2687,32906032,The MUC5B promoter variant does not predict progression of interstitial lung disease in systemic sclerosis.,"OBJECTIVE


To investigate the prevalence of the MUC5B promoter variant rs35705950 in patients with systemic sclerosis-interstitial lung disease (SSc-ILD) and whether its presence predicts response to immunosuppression with cyclophosphamide (CYC) and mycophenolate (MMF).
METHODS


SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N = 142). TaqMan Genotyping Assays were used to determine the MUC5B rs35705950 single nucleotide polymorphism. Joint models were created to examine how the presence of this variant affected the course of the forced vital capacity (FVC) over 2 years. Linear regression models were used to investigate the relationship between the presence of this variant and the change in quantitative radiographic fibrosis.
RESULTS


Among 128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele. Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%). The presence of the MUC5B variant did not affect the course of the FVC, nor the change in quantitative radiographic fibrosis, ground glass or ILD scores in either treatment arm.
CONCLUSION


In the context of a randomized controlled trial for SSc-ILD, the presence of the MUC5B variant did not predict disease severity, nor affect treatment response to MMF or CYC. Future studies are needed to determine whether this variant affects ILD progression in other SSc cohorts and in patients receiving anti-fibrotic therapy.",2020,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","['patients with systemic sclerosis-interstitial lung disease (SSc-ILD', '128 participants who were tested for this variant, 18% possessed at least one copy of the MUC5B minor allele', 'SSc-ILD patients who participated in Scleroderma Lung Study (SLS) II (MMF versus CYC) were included in this study (N\u202f=\u202f142']","['MUC5B promoter variant rs35705950', 'cyclophosphamide (CYC) and mycophenolate (MMF']","['quantitative radiographic fibrosis, ground glass or ILD scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0537987', 'cui_str': 'Mucin-5 Subtype B, Tracheobronchial'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0532196,"Patients with at least one copy of this allele were similar to those without the allele with respect to age, sex, SSc subtype, ILD disease severity; however, this variant was rare among African Americans (3.7%).","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA. Electronic address: evolkmann@mednet.ucla.edu.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Charles', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Mayes', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA; Department of Biostatistics, University of California, Los Angeles, Fielding School of Public Health Los Angeles, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Pourzand', 'Affiliation': 'Department of Radiology, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'Department of Medicine, University of California, Los Angeles, David Geffen School of Medicine, USA; Department of Medicine, University of Washington, Seattle, USA; Department of Rheumatology, University of Florence, Florence, Italy.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Department of Medicine, University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'Department of Biomathematics, University of California, Los Angeles, USA.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX, USA.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.06.003']
2688,32906128,Effects of Craniosacral Osteopathy in Patients with Peripheral Vestibular Pathology.,"INTRODUCTION


Vertigo appears as a result of a sudden neural activity imbalance of the vestibular system. The vertigo prevalence is higher in patients over 60 years of age compared to patients under 40 years of age.
OBJECTIVES


The purpose of this study was to analyze the effect of craniosacral osteopathy on dizziness and balance in individuals who have peripheral vestibular pathology.
METHODS


A total of 30 individuals, aged 24-50 years, participated in this study. Twenty-four of the participants were female (80%) and 6 were male (20%). The participants were separated into 2 groups, with 15 patients included in the cranial osteopathy treatment group (study group) and 15 patients included in the group that used dimenhydrinate (control group). The individuals were evaluated in terms of dizziness and balance. A visual analog scale was used to evaluate dizziness. Balance was evaluated using the Berg balance scale and the Activities-Specific Balance Confidence scale. The craniosacral treatment program was applied once per week for 6 sessions. All of the individuals included in this study were evaluated 3 times, i.e., prior to treatment, on the third week of treatment, and on the sixth week of treatment.
RESULTS


Significant improvement was noted within each group in terms of dizziness and balance (p < 0.05). When the groups were compared with each other, it was observed that craniosacral osteopathy was more effective than dimenhydrinate treatment for dizziness and balance (p < 0.05).
CONCLUSION


Craniosacral osteopathy is an effective treatment choice in individuals who have chronic peripheral vestibular pathology. In individuals who have resistant and chronic vestibular pathology, craniosacral osteopathy should be evaluated among the treatment choices.",2020,"RESULTS


Significant improvement was noted within each group in terms of dizziness and balance (p < 0.05).","['individuals who have chronic peripheral vestibular pathology', 'individuals who have peripheral vestibular pathology', 'Patients with Peripheral Vestibular Pathology', 'Twenty-four of the participants were female (80%) and 6 were male (20', 'A total of 30 individuals, aged 24-50 years']","['Craniosacral Osteopathy', 'craniosacral osteopathy', 'dimenhydrinate (control group']","['dizziness', 'vertigo prevalence', 'dizziness and balance', 'Berg balance scale and the Activities-Specific Balance Confidence scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0005940', 'cui_str': 'Disorder of bone'}, {'cui': 'C0012381', 'cui_str': 'Dimenhydrinate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C2733457', 'cui_str': 'Activities specific balance confidence scale'}]",,0.0170749,"RESULTS


Significant improvement was noted within each group in terms of dizziness and balance (p < 0.05).","[{'ForeName': 'Feride', 'Initials': 'F', 'LastName': 'Atay', 'Affiliation': 'Department of Physical Therapy, Hasan Kalyoncu University, Gaziantep, Turkey.'}, {'ForeName': 'Kezban', 'Initials': 'K', 'LastName': 'Bayramlar', 'Affiliation': 'Department of Physical Therapy, Hasan Kalyoncu University, Gaziantep, Turkey.'}, {'ForeName': 'Elif Tugba', 'Initials': 'ET', 'LastName': 'Sarac', 'Affiliation': 'Department of Audiology, Ear-Nose-Throat Department, Mustafa Kemal University Medicine Faculty, Hatay, Turkey, tugbasarac2901@yahoo.com.'}]",ORL; journal for oto-rhino-laryngology and its related specialties,['10.1159/000509486']
2689,32906135,Tubular Biomarkers and Chronic Kidney Disease Progression in SPRINT Participants.,"BACKGROUND


Kidney tubular atrophy on biopsy is a strong predictor of chronic kidney disease (CKD) progression, but tubular health is poorly quantified by traditional measures including estimated glomerular filtration rate (eGFR) and albuminuria. We hypothesized that urinary biomarkers of impaired tubule function would be associated with faster eGFR declines in persons with CKD.
METHODS


We measured baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m) among 2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2. We used linear mixed models to evaluate biomarker associations with annualized relative change in eGFR, stratified by randomization arm.
RESULTS


At baseline, the mean age was 73 ± 9 years and eGFR was 46 ± 11 mL/min/1.73 m2. In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10 [95% CI: -0.18, -0.02]) in multivariable-adjusted models including baseline eGFR and albuminuria. Associations were weaker and did not reach statistical significance in the intensive blood pressure treatment arm for either uromodulin (0.11 [-0.13, 0.35], p value for interaction by treatment arm = 0.045) or β2m (-0.01 [-0.08, 0.08], p value for interaction = 0.001). Urinary α1m was not independently associated with eGFR decline in the standard (0.01 [-0.22, 0.23]) or intensive (0.03 [-0.20, 0.25]) arm.
CONCLUSIONS


Among trial participants with hypertension and CKD, baseline measures of tubular function were associated with subsequent declines in kidney function, although these associations were diminished by intensive blood pressure control.",2020,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","['2,428 participants of the Systolic Blood Pressure Intervention Trial with an eGFR <60 mL/min/1.73 m2', 'persons with CKD', 'SPRINT Participants']",[],"['baseline urine concentrations of uromodulin, β2-microglobulin (β2m), and α1-microglobulin (α1m', 'Tubular Biomarkers and Chronic Kidney Disease Progression', 'annual eGFR decline', 'eGFR decline', 'intensive blood pressure control', 'kidney function', 'Urinary α1m', 'glomerular filtration rate (eGFR) and albuminuria']","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid protein'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",2428.0,0.0823971,"In the standard blood pressure treatment arm, each 2-fold higher urinary uromodulin was associated with slower % annual eGFR decline (0.34 [95% CI: 0.08, 0.60]), whereas higher urinary β2m was associated with faster % annual eGFR decline (-0.10","[{'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA, vasantha.jotwani@ucsf.edu.'}, {'ForeName': 'Pranav S', 'Initials': 'PS', 'LastName': 'Garimella', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Drawz', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Barry I', 'Initials': 'BI', 'LastName': 'Freedman', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Department of Medicine, Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Punzi', 'Affiliation': 'Punzi Medical Center, Trinity Hypertension Research Institute, Carollton, Texas, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sarnak', 'Affiliation': 'Department of Medicine, Tufts Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Segal', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Department of Medicine, San Francisco VA Medical Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of nephrology,['10.1159/000509978']
2690,32702263,Intermittent hypoxia enhances shear-mediated dilation of the internal carotid artery in young adults.,"Cyclic intermittent hypoxia (IH) increases cerebral blood velocity. This enhanced velocity augments the commensurate shear stimulus and may subsequently increase cerebrovascular endothelial function. This study aimed to examine the effects of cyclic IH on hypercapnia-induced shear-mediated dilation of the internal carotid artery (ICA), a potential index of cerebrovascular endothelial function. Shear-mediated dilation was measured in nine adults (22 ± 4 yr) before as well as after 50 min of cyclic IH [5 cycles, 4 min of normoxia, followed by 6 min of hypoxia (target 80% [Formula: see text]) per cycle] and control normoxia (sham, 50 min of continuous normoxia) on separate days (≥72 h apart). ICA diameter and velocity were measured using Doppler ultrasound during cyclic IH and hypercapnia. Shear-mediated dilation was induced by 3 min of hypercapnia (Δ[Formula: see text]; IH: pre 10.1 ± 1.0 mmHg, post 10.8 ± 1.3 mmHg; sham: pre 10.5 ± 1.5 mmHg, post 10.8 ± 1.5 mmHg) and was calculated as the percent rise in peak relative to baseline diameter. Hypoxia increased ICA blood flow and shear rate (SR) during each cycle [blood flow: 322 ± 90 to 406 ± 74 mL/min,  P  < 0.01; SR: 179 ± 42 to 207 ± 55/s,  P  = 0.06, baseline to hypoxia (average of last minute of each cycle)], which was normalized during the succeeding normoxic period (blood flow: 322 ± 90 to 329 ± 68 mL/min,  P  = 0.54, SR: 179 ± 42 to 176 ± 32/s,  P  = 0.56). As such, shear-mediated dilation increased following cyclic IH (4.6 ± 1.3% to 6.2 ± 2.2%,  P  < 0.01), but not control normoxia (4.9 ± 1.4% to 4.9 ± 1.4%,  P  = 0.92). Our data indicate that increased blood flow and SR during cyclic IH enhance shear-mediated dilation of the ICA in young adults. These results suggest that cyclic IH could be used to optimize cerebral vascular health. NEW & NOTEWORTHY  We explored the effects of cyclic intermittent hypoxia (IH) on shear-mediated dilation of the internal carotid artery (ICA), a potential index of cerebral endothelial function, in young adults. Cyclic IH increased blood flow and shear rate in the ICA and, as a result, increased shear-mediated dilation of the ICA. These data suggest that cyclic IH could potentially be applied as a nonpharmacological therapy to optimize cerebral vascular health.",2020,"[blood flow: 322 ± 90 to 406 ± 74 mL/min,  P  < 0.01; SR: 179 ± 42 to 207 ± 55/s,  P  = 0.06, baseline to hypoxia (average of last minute of each cycle)], which was normalized during the succeeding normoxic period (blood flow: 322 ± 90 to 329 ± 68 mL/min,  P  = 0.54, SR: 179 ± 42 to 176 ± 32/s,  P  = 0.56).",['young adults'],"['control normoxia (sham, 50 min of continuous normoxia', 'cyclic intermittent hypoxia (IH', 'cyclic IH', 'Cyclic intermittent hypoxia (IH']","['ICA diameter and velocity', 'cerebrovascular endothelial function', 'Hypoxia increased ICA blood flow and shear rate (SR', 'blood flow and shear rate', 'Shear-mediated dilation', 'blood flow and SR', 'cerebral blood velocity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439596', 'cui_str': 'Cyclic'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}]",,0.046749,"[blood flow: 322 ± 90 to 406 ± 74 mL/min,  P  < 0.01; SR: 179 ± 42 to 207 ± 55/s,  P  = 0.06, baseline to hypoxia (average of last minute of each cycle)], which was normalized during the succeeding normoxic period (blood flow: 322 ± 90 to 329 ± 68 mL/min,  P  = 0.54, SR: 179 ± 42 to 176 ± 32/s,  P  = 0.56).","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Iwamoto', 'Affiliation': 'Human Integrative and Cardiovascular Physiology Laboratory, Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Brady E', 'Initials': 'BE', 'LastName': 'Hanson', 'Affiliation': 'Human Integrative and Cardiovascular Physiology Laboratory, Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Bock', 'Affiliation': 'Human Integrative and Cardiovascular Physiology Laboratory, Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Darren P', 'Initials': 'DP', 'LastName': 'Casey', 'Affiliation': 'Human Integrative and Cardiovascular Physiology Laboratory, Department of Physical Therapy and Rehabilitation Science, University of Iowa, Iowa City, Iowa.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00274.2020']
2691,32911433,Rationale and methods of the Advanced R 2 Eperfusion STrategies for Refractory Cardiac Arrest (ARREST) trial.,"BACKGROUND


Venoarterial extracorporeal membrane oxygenation has emerged as a prominent therapy for patients with refractory cardiac arrest. However, the optimal time of initiation remains unknown.
AIM


The aim was to assess the rate of survival to hospital discharge in adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention, when needed, or (2) standard advanced cardiac life support resuscitation.
DESIGN


Phase II, single-center, partially blinded, prospective, intention-to-treat, safety and efficacy clinical trial.
POPULATION


Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30 minutes.
SETTING


Hospital-based.
OUTCOMES


Primary: survival to hospital discharge. Secondary: safety, survival, and functional assessment at hospital discharge and 3 and 6 months, and cost.
SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
CONCLUSIONS


The ARREST trial will generate safety/effectiveness data and comparative costs associated with extracorporeal cardiopulmonary resuscitation, informing broader implementation and a definitive Phase III clinical trial.",2020,"SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
","['Adults (aged 18-75), initial out-of-hospital cardiac arrest rhythm of ventricular fibrillation/pulseless ventricular tachycardia, no ROSC following 3 shocks, body morphology to accommodate a Lund University Cardiac Arrest System automated cardiopulmonary resuscitation device, and transfer time of <30\u202fminutes', 'adult patients with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest treated with 1 of 2 local standards of care: (1) early', 'patients with refractory cardiac arrest', 'Hospital-based']","['venoarterial extracorporeal membrane oxygenation-facilitated resuscitation for circulatory support and percutaneous coronary intervention', 'extracorporeal cardiopulmonary resuscitation']","['rate of survival to hospital discharge', 'survival to hospital discharge', 'success rates', 'safety, survival, and functional assessment at hospital discharge and 3 and 6\u202fmonths, and cost']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0750196', 'cui_str': 'Pulseless ventricular tachycardia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0183001', 'cui_str': 'Cardiopulmonary resuscitator'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C5192097', 'cui_str': 'Venoarterial extracorporeal membrane oxygenation'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",174.0,0.0924829,"SAMPLE SIZE


Assuming success rates of 12% versus 37% in the 2 arms and 90% power, a type 1 error rate of .05, and a 15% rate of withdrawal prior to hospital discharge, the required sample size is N = 174 evaluated patients.
","[{'ForeName': 'Demetris', 'Initials': 'D', 'LastName': 'Yannopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN. Electronic address: yanno001@umn.edu.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Kalra', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Kosmopoulos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Walser', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Bartos', 'Affiliation': 'Center for Resuscitation Medicine, University of Minnesota, Medical School, Cardiovascular Division, Minneapolis, MN.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Murray', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee, WI.'}]",American heart journal,['10.1016/j.ahj.2020.07.006']
2692,32911462,On-Site Computed Tomography Versus Angiography Alone to Guide Coronary Stent Implantation: A Prospective Randomized Study.,"OBJECTIVES


The effect of intraprocedural coronary computed tomography angiography (coronary CTA) guidance on percutaneous coronary intervention (PCI) is unknown. We sought to determine the influence of CTA guidance on procedural strategies and immediate angiographic outcomes of PCI.
METHODS


Sixty patients were randomized to CTA-guided PCI (29 patients, 36 lesions) or angiography-guided PCI (31 patients, 39 lesions). To enable hands-free manipulation of CTA images by the interventional cardiologist during PCI, we developed an onsite augmented-reality (AR) system comprising a mobile application and AR glass. The primary endpoints were defined as: (1) stent length; and (2) largest stent diameter according to compliance chart. Procedural strategies, two-dimensional (2D) and three-dimensional (3D) quantitative coronary angiography (QCA), and safety outcomes were compared.
RESULTS


Whereas CTA guidance resulted in significantly higher frequency of stent postdilation using non-compliant (67% vs 31%; P<.01) and shorter balloons (16.6 ± 5.4 mm vs 20.5 ± 9.4 mm; P=.04) with numerically larger diameter (3.50 ± 0.63 mm vs 3.28 ± 0.45 mm; P=.10), it did not differ from angiography guidance with respect to lesion predilation, stent length, largest stent diameter according to compliance chart, and nominal stent diameter. The results of 2D- and 3D-QCA and safety outcomes were similar between groups. Neither death nor stroke occurred in either group.
CONCLUSIONS


PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.",2020,"CONCLUSIONS


PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.","['29 patients, 36 lesions) or', 'Sixty patients']","['angiography-guided PCI', 'CTA-guided PCI', 'intraprocedural coronary computed tomography angiography (coronary CTA) guidance', 'CTA guidance', 'Site Computed Tomography Versus Angiography Alone to Guide Coronary Stent Implantation']","['2D- and 3D-QCA and safety outcomes', 'death nor stroke', 'Procedural strategies, two-dimensional (2D) and three-dimensional (3D) quantitative coronary angiography (QCA), and safety outcomes', 'stent length; and (2) largest stent diameter according to compliance chart', 'frequency of stent postdilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0449462', 'cui_str': 'Length of stent'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",60.0,0.0852343,"CONCLUSIONS


PCI under intraprocedural CTA guidance is associated with similar stent size selection and more frequent stent postdilation, resulting in comparable immediate angiographic and safety outcomes as compared with PCI under angiographic guidance alone.","[{'ForeName': 'Maksymilian P', 'Initials': 'MP', 'LastName': 'Opolski', 'Affiliation': 'Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Alpejska 42, 04- 628 Warsaw, Poland. opolski.mp@gmail.com.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Niels J W', 'Initials': 'NJW', 'LastName': 'Verouden', 'Affiliation': ''}, {'ForeName': 'Pepijn A', 'Initials': 'PA', 'LastName': 'van Diemen', 'Affiliation': ''}, {'ForeName': 'Bartosz A', 'Initials': 'BA', 'LastName': 'Borucki', 'Affiliation': ''}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Sprengers', 'Affiliation': ''}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': ''}, {'ForeName': 'Ruben W', 'Initials': 'RW', 'LastName': 'de Winter', 'Affiliation': ''}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nap', 'Affiliation': ''}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Bom', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Knaapen', 'Affiliation': ''}]",The Journal of invasive cardiology,[]
2693,32911474,Fluoride Varnish in Nursery Schools: A Randomised Controlled Trial - Protecting Teeth @3.,"Studies suggest that fluoride varnish (FV) application can reduce dental caries in child populations. The multiple-component national child oral health improvement programme in Scotland (Childsmile) includes nursery-based universal supervised toothbrushing and deprivation-targeted FV applications, together with community and dental practice prevention interventions. This trial, a double-blind, two-arm randomised control trial, aimed to assess the effectiveness and cost-effectiveness of the nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions, compared to TAU Childsmile interventions alone, in children not targeted to receive nursery FV as part of the programme. Participating children in the first year of nursery (aged three), with or without existing caries, were randomised to either FV or TAU and followed up for 24 months until the first year of primary school. Treatments were administered at six-monthly intervals. The primary endpoint was ""worsening of d3mft"" from baseline to 24 months. Secondary endpoints were worsening of d3mfs, d3t, mt, and ft. Individual record-linkage captured wider programme activities and tertiary endpoints. A total of 1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573 TAU, 10% dropouts). Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups. Most children received three/four treatments. Overall, 26.9% (n = 155) had worsened d3mft in the FV group, and 31.6% (n = 181) in the TAU group, with an odds ratio (OR) of 0.80 (0.62-1.03), p = 0.078. The results for worsening of the secondary endpoints were: d3mfs 0.79 (0.61-1.01) p = 0.063, d3t 0.75 (0.57-0.99) p = 0.043, mt 1.34 (0.75-2.39) p = 0.319, and ft 0.77 (0.53-1.14) p = 0.191. We calculated a number needed to treat of 21 and a cost of GBP 686 to prevent a single worsening of d3mft. There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.",2020,"There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.","['1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573', 'children not targeted to receive nursery FV as part of the programme', 'Nursery Schools', 'child populations', 'Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups', 'Participating children in the first year of nursery (aged three), with or without existing caries']","['FV or TAU', 'fluoride varnish (FV) application', 'Fluoride Varnish', 'nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions']","['effectiveness and cost-effectiveness', 'worsening of d3mft', 'worsening of d3mfs, d3t, mt, and ft']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0036379', 'cui_str': 'Nursery school'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",1284.0,0.209769,"There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.","[{'ForeName': 'Alex D', 'Initials': 'AD', 'LastName': 'McMahon', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom, alex.mcmahon@glasgow.ac.uk.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wright', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Anopa', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economic and Health Technology Assessment, Institute of Health and Wellbeing (MVLS), University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Conway', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Lorna M D', 'Initials': 'LMD', 'LastName': 'Macpherson', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}]",Caries research,['10.1159/000509680']
2694,32911505,On the developmental origin of intrinsic honesty.,"Contrary to the self-interestedness assumption, numerous economic studies have documented that people are intrinsically honest. However, little is known about this trait's developmental origin. This study examines whether and the extent to which children in early childhood incur the intrinsic lying cost. We modified the commonly used coin-flip task into a child-friendly ball-drawing task with 10 trials and conducted the experiment with 225 child participants aged three to eight years old. We found that-although young children, on average, told two lies in the task (an average winning rate of 71%)-they lied significantly less than the maximum level (i.e., lying 100% of the time). The pattern was largely similar across gender and the age range studied. Furthermore, our child subjects' propensity to lie dropped by approximately 9% when they were randomly assigned to the treatment condition with an increased ""perceived"" intrinsic cost of lying. Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.",2020,"Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.",['225 child participants aged three to eight years old'],[],[],"[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],[],225.0,0.0162522,"Overall, our results align with the innate morality hypothesis: young children, as young as three years old, are willing to give up pecuniary rewards in order to remain honest.","[{'ForeName': 'Tai-Sen', 'Initials': 'TS', 'LastName': 'He', 'Affiliation': 'Economics Programme, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0238241']
2695,32911530,Association of strength and plyometric exercises with change of direction performances.,"The change of direction (COD) ability is an important task-specific skill for success in team sports, dependent on both strength and reactive strength. The sprint approaching the COD and degrees of the turn are factors influencing the specificity of the COD. Thus, CODs have been suggested to be categorized as force- (> 90°) and velocity-dominant (< 90°) dependent on the degree of the turn. When training programmes fail to provide a significant increase in COD performance, it is often due to neglecting the task-specific demands of the COD. As such, 23 male football players volunteered to complete a randomized controlled trial, investigating the association of maximal strength and power performance with performance in a force- (180°) and velocity-dominant (45°) COD, with a 4 m and 20 m sprint approach. Three strength and three plyometric exercises, matched in movement patterns, were used. Muscle activity of the different conditions was also compared. The correlational analysis revealed that better performance in the plyometric tests were associated with less time to complete both force- and velocity-dominant CODs, supported by similarities in muscle activation. None of the performances in strength exercises correlated to COD performance, due to the slow contraction velocity of maximal lifts. It was concluded that plyometrics share more physical similarities with CODs than the strength exercises.",2020,"The correlational analysis revealed that better performance in the plyometric tests were associated with less time to complete both force- and velocity-dominant CODs, supported by similarities in muscle activation.",['23 male football players volunteered'],"['strength and plyometric exercises', 'force- (180°) and velocity-dominant (45°) COD, with a 4 m and 20 m sprint approach']","['slow contraction velocity of maximal lifts', 'Muscle activity', 'COD performance', 'change of direction (COD) ability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",23.0,0.0286141,"The correlational analysis revealed that better performance in the plyometric tests were associated with less time to complete both force- and velocity-dominant CODs, supported by similarities in muscle activation.","[{'ForeName': 'Hallvard Nygaard', 'Initials': 'HN', 'LastName': 'Falch', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}, {'ForeName': 'Håvard Guldteig', 'Initials': 'HG', 'LastName': 'Rædergård', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Science and Physical Education, Nord University, Levanger, Norway.'}]",PloS one,['10.1371/journal.pone.0238580']
2696,32911627,"Adherence Measures for Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Abiraterone Acetate plus Prednisone: Results of a Prospective, Cluster-Randomized Trial.","Residual androgen production causes tumor progression in metastatic, castration-resistant prostate cancer (mCRPC) patients. Abiraterone acetate (AA), a prodrug of abiraterone, is an oral CYP-17 inhibitor that blocks androgen production. It was hypothesized that adherence-enhancing measures (AEM) might be beneficial for mCRPC patients receiving abiraterone acetate plus prednisone (AA + P). This multicenter, prospective, 2-arm trial allocated mCRPC patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization. The primary objective was to assess the influence of AEM on discontinuation rates and medication adherence in mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B. At month 3, the rate of treatment discontinuation, not due to disease progression or the start of new cancer therapy, was low in both arms (A: 9.0% vs. B: 7.3%, OR = 1.230). Few patients had a medium/low Morisky Medication Adherence Scale (MMAS-4) score (A: 6.4% vs. B: 9.1%, OR = 0.685). The results obtained did not suggest any clear adherence difference between Arm A and Arm B. In patients with mCRPC taking AA + P medication, adherence seemed to be generally high.",2020,The results obtained did not suggest any clear adherence difference between Arm A and Arm B.,"['mCRPC patients receiving', 'Patients with Metastatic Castration-Resistant Prostate Cancer Treated with', 'metastatic, castration-resistant prostate cancer (mCRPC) patients', 'patients who were progressive after docetaxel-based chemotherapy or asymptomatic/mildly symptomatic after failure of an androgen deprivation therapy to Arm A (with AEM) or Arm B (without AEM) by center-based cluster-randomization', 'mCRPC patients treated with AA + P. A total of 360 patients were allocated to Arm A, and 315 patients to Arm B']","['abiraterone acetate plus prednisone', 'Residual androgen production', 'Abiraterone Acetate plus Prednisone', 'Abiraterone acetate (AA', 'mCRPC', 'AEM']","['discontinuation rates and medication adherence', 'rate of treatment discontinuation', 'medium/low Morisky Medication Adherence Scale (MMAS-4) score']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319607', 'cui_str': '360'}]","[{'cui': 'C2607886', 'cui_str': 'Abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",360.0,0.0570704,The results obtained did not suggest any clear adherence difference between Arm A and Arm B.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Suttmann', 'Affiliation': 'Private Practice, Urologikum Hamburg, 22399 Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Gleissner', 'Affiliation': 'Private Practice, MVZ-DGU-Die GesundheitsUnion GmbH, 42103 Wuppertal, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huebner', 'Affiliation': 'Private Practice, Center for Oncology and Urology, 18107 Rostock, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Mathes', 'Affiliation': 'Institut für Forschung in der Operativen Medizin, University Witten/Herdecke, 51109 Cologne, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Baurecht', 'Affiliation': 'Biometrics, Acromion GmbH, 50226 Frechen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Krützfeldt', 'Affiliation': 'Medical Affairs, Janssen-Cilag GmbH, 41470 Neuss, Germany.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Sweiti', 'Affiliation': 'Clinical Development, Janssen Research and Development LLC, Pennsylvania, PA 19477, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Feyerabend', 'Affiliation': 'Private Practice Studienpraxis Urologie, 72622 Nürtingen, Germany.'}]",Cancers,['10.3390/cancers12092550']
2697,32911680,Metabonomic Responses of Grazing Yak to Different Concentrate Supplementations in Cold Season.,"Supplementation plays an important role in reversing the weight loss of grazing yaks during cold season. However, little is known about the effect of supplementation on the serum metabolites of grazing yaks. The objective of this study was to explore the effects of supplementary feeding on average daily gain (ADG) and serum metabolites with nuclear magnetic resonance (NMR)-based metabolomics method in growing yaks during cold season on the Qinghai-Tibetan plateau. Twenty 1.5-year-old female yaks (91.38 ± 10.43 kg LW) were evenly divided into three treatment groups and a control group (CON) ( n  = 5 per group). All the yaks were released to graze during daytime, whereas the yaks in the treatment groups were supplemented with highland barley (HLB), rapeseed meal (RSM), and highland barley plus rapeseed meal (HLB + RSM) at night. The whole experiment lasted for 120 days. Results indicated that the ADG of growing yak heifers was increased by concentrate supplementations, and ADG under HLB and HLB + RSM group was 37.5% higher ( p  < 0.05) than that with RSM supplementation. Supplementary feeding increased the plasma concentrations of total protein (TP), albumin (ALB), and blood urea nitrogen (BUN) of those in the CON group, and concentrations of BUN were higher in the RSM group than in the HLB and HLB + RSM group. Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group. Compared with the HLB + RSM group, serum levels of glycerophosphoryl choline (GPC) and lactate were higher, and those of choline, glutamine, glutamate, leucine,  N -acetyaspartate, α-glucose, and β-glucose were lower in the HLB group; serum levels of citrate, GPC and lactate were higher, and those of 3-Hydroxybutyrate, betaine, choline, glutamate, glutamine,  N -acetylglycoprotein,  N -acetyaspartate, α-glucose, and β-glucose were lower in the RSM group. It could be concluded that concentrate supplementations significantly improved the growth performance of growing yaks and supplementation with HBL or HLB plus RSM was better than RSM during the cold season. Supplementation with HBL or HLB plus RSM affected the serum metabolites of grazing yaks, and both treatments promoted lipid synthesis. Supplementation of yaks with HBL plus RSM could improve energy-supply efficiency, protein and lipid deposition compared with HLB and RSM.",2020,"Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group.",['Twenty 1.5-year-old female yaks (91.38 ± 10.43 kg LW'],"['RSM', 'HLB + RSM', 'HBL plus RSM', 'HBL or HLB plus RSM', 'control group (CON', 'CON', 'supplementary feeding', 'highland barley (HLB), rapeseed meal (RSM), and highland barley plus rapeseed meal (HLB + RSM']","['average daily gain (ADG) and serum metabolites', 'serum metabolites of grazing yaks', 'growth performance', '3-Hydroxybutyrate, betaine, choline, glutamate, glutamine,  N -acetylglycoprotein,  N -acetyaspartate, α-glucose, and β-glucose', 'concentrations of BUN', 'serum levels of glycerophosphoryl choline (GPC) and lactate', 'choline, glutamine, glutamate, leucine,  N -acetyaspartate, α-glucose, and β-glucose', 'serum levels of lactate', 'serum levels of citrate, GPC and lactate', 'energy-supply efficiency, protein and lipid deposition', 'serum levels of glutamine, glycine, β-glucose', 'plasma concentrations of total protein (TP), albumin (ALB), and blood urea nitrogen (BUN', 'lipid synthesis']","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0325253', 'cui_str': 'Bos grunniens'}]","[{'cui': 'C0206624', 'cui_str': 'Hepatoblastoma'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038847', 'cui_str': 'Complementary Feeding'}, {'cui': 'C0454911', 'cui_str': 'Highland'}, {'cui': 'C0004755', 'cui_str': 'Hordeum'}, {'cui': 'C0034670', 'cui_str': 'Brassica rapa'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0325253', 'cui_str': 'Bos grunniens'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C1415375', 'cui_str': 'Glycophorin D'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1563744', 'cui_str': 'Lipogenesis'}]",,0.0214806,"Compared with the CON group, serum levels of glutamine, glycine, β-glucose were lower and that of choline was higher in the HLB group; serum levels of lactate were lower and that of choline, glutamate were higher in the HLB + RSM group.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Shuangming', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Quanhui', 'Initials': 'Q', 'LastName': 'Peng', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Zhisheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}, {'ForeName': 'Bai', 'Initials': 'B', 'LastName': 'Xue', 'Affiliation': 'Animal Nutrition Institute, Sichuan Agricultural University, Chengdu 611130, China.'}]",Animals : an open access journal from MDPI,['10.3390/ani10091595']
2698,32911733,Impact of Short Foot Muscle Exercises on Quality of Movement and Flexibility in Amateur Runners.,"The flexibility and proper functioning of all myofascial chains are crucial for athletes, especially for long-distance runners. Due to the continuity of the myofascial structures, restrictions in one part of the body may cause excessive tension in others. The aim of our study was to evaluate the influence of short foot muscle exercises on muscle flexibility and the quality of movement patterns in amateur runners. Eighty long-distance runners, aged 20-45, were randomly divided into two groups: Group 1 ( n  = 48) and Group 2 ( n  = 32). Participants in Group 1 performed foot exercises daily for six weeks. Subjects in Group 2 were without any intervention. At baseline and after six weeks, the quality of movement patterns with the Functional Movement Screen and muscle flexibility was evaluated. In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks. The total score increased from 17 to 18 points (Median (Me) ± half of interquartile range (IQR/2) (Standard Error of Measurement - SEM) 17 ± 1.5 (0.23) at baseline and 18 ± 1.5 (0.24) after six weeks) ( p  < 0.01), whereas in Group 2, its level remained at 16 points (Me ± IQR/2 (SEM) 16 ± 1.5 (0.31) at baseline and 16 ± 1.25 (0.31) after six weeks). In Group 1, the significant improvement in muscle flexibility was noted (e.g., results for external rotation muscles: (Mean ± SD (SEM) 60.3 ± 0.4 (1.50) at baseline and 62.4 ± 10.3 (1.49) after six weeks) ( p  = 0.005). In Group 2, significant improvement was observed only for one task in the Active straight leg raise test ( p  = 0.005 and 0.02). During the measurement of external rotation muscles, a significant decrease in flexibility was observed (Mean ± SD (SEM) 60.1 ± 9.0 (1.60) at baseline and 58.0 ± 8.5 (1.51) after six weeks) ( p  = 0.001). Plantar short foot muscle exercises may improve muscle flexibility in the upper parts of the body within myofascial chains and influence the quality of fundamental movement patterns. Such exercises may be beneficial for all physically active people and can be performed as part of overall fitness programmes. Moreover, including such exercises in daily training routines of long-distance runners, as well as by athletes in other sport disciplines is also recommended.",2020,"In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks.","['Eighty long-distance runners, aged 20-45', 'amateur runners', 'Amateur Runners']","['short foot muscle exercises', 'Plantar short foot muscle exercises', 'Short Foot Muscle Exercises']","['quality of movement patterns with the Functional Movement Screen and muscle flexibility', 'total score', 'flexibility', 'Quality of Movement and Flexibility', 'external rotation muscles', 'muscle flexibility and the quality of movement patterns', 'muscle flexibility', 'Active straight leg raise test']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0576226', 'cui_str': 'Short foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}]",80.0,0.0325762,"In Group 1, significantly higher Functional Movement Screen values in individual tasks and in the total score were noted after six weeks.","[{'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Sulowska-Daszyk', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mika', 'Affiliation': 'Institute of Clinical Rehabilitation, University of Physical Education in Krakow, 31-571 Krakow, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Oleksy', 'Affiliation': 'Physiotherapy and Sports Centre, Rzeszow University of Technology, 35-959 Rzeszow, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17186534']
2699,32911776,Communicating Evidence about the Causes of Obesity and Support for Obesity Policies: Two Population-Based Survey Experiments.,"Public support for numerous obesity policies is low, which is one barrier to their implementation. One reason for this low support is the tendency to ascribe obesity to failings of willpower as opposed to the environment. Correlational evidence supports this position. However, the experimental evidence is mixed. In two experimental studies, participants were randomised to receive no message, messages about the environment's influence on obesity (Study 1 & 2), or messages about the environment's influence on human behaviour (Study 1). We investigated whether communicating these messages changed support for obesity policies and beliefs about the causes of obesity. Participants were recruited from nationally representative samples in Great Britain (Study 1 & 2) and the USA (Study 2) (total  n  = 4391). Study 2 was designed to replicate existing research. Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity. Study 2, therefore, did not replicate two earlier experimental studies. Instead, the studies reported here suggest that people's beliefs about the causes of obesity are resistant to change in response to evidence and are, therefore, not a promising avenue to increase support for obesity policies.",2020,Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity.,['Participants were recruited from nationally representative samples in Great Britain (Study 1 & 2) and the USA (Study 2) (total  n  = 4391'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",[],[],,0.0341881,Neither study found evidence that communicating the messages increased support for obesity policies or strengthened beliefs about the environment's role in obesity.,"[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Reynolds', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Vasiljevic', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pilling', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Kurt M', 'Initials': 'KM', 'LastName': 'Ribisl', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27514, USA.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, University of Cambridge, Cambridge CB2 0SR, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17186539']
2700,32912292,Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial.,"BACKGROUND


Robotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups.
METHODS AND ANALYSIS


This prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Bromley Research Ethics Committee, UK. The study is sponsored by University College London, UK.
DISCUSSION


This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.",2020,Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups.,"['University College London, UK', '60 patients with symptomatic hip osteoarthritis undergoing primary THA', 'total hip arthroplasty']","['CT-planned CO THA versus CT-planned RO THA', 'Preoperative pelvic computerised tomography (CT) scans', 'CO THA (control group) or RO THA', 'Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty', 'Robotic-arm assisted surgery', 'conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA']","['patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications', 'accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications', 'accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029410', 'cui_str': 'Osteoarthritis of hip'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]",60.0,0.149578,Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups.,"[{'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Kayani', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK. babar.kayani@gmail.com.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Konan', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Tahmassebi', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Ayuob', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Fares S', 'Initials': 'FS', 'LastName': 'Haddad', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}]",Trials,['10.1186/s13063-020-04702-7']
2701,32912298,Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled trial.,"BACKGROUND


Poor ovarian response (POR), a manifestation of low ovarian reserve and ovarian aging, leads to a significant reduction in the pregnancy rate after in vitro fertilization-embryo transfer. Acupuncture has increasingly been used to improve the ovarian reserve. The purpose of this study will be to evaluate the effect of acupuncture on increasing the number of retrieved oocytes after controlled ovarian hyperstimulation in women with POR.
METHODS


This will be a multicenter randomized controlled trial. A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation. The primary outcome will be the number of retrieved oocytes. The secondary outcomes will be antral follicle counts, serum levels of anti-Müllerian hormone, basal serum levels of follicle stimulating hormone, luteinizing hormone and estradiol levels, scores from the self-rating anxiety scale, fertilization rates, cleavage rates, available embryo rates, and high-quality embryo rates. The safety of acupuncture will also be assessed.
DISCUSSION


The results of this trial will help to determine the effectiveness of acupuncture in the treatment of POR. This may provide a new treatment option for patients with POR and their physicians.
TRIAL REGISTRATION


AMCTR-IPR-18000198 . Registered on 10 August 2018.",2020,A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation.,"['women with POR', 'women with poor ovarian response', '140 women with POR', 'patients with POR and their physicians']","['Acupuncture', 'acupuncture']","['antral follicle counts, serum levels of anti-Müllerian hormone, basal serum levels of follicle stimulating hormone, luteinizing hormone and estradiol levels, scores from the self-rating anxiety scale, fertilization rates, cleavage rates, available embryo rates, and high-quality embryo rates', 'number of retrieved oocytes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}]",140.0,0.369149,A total of 140 women with POR will be randomly assigned to receive acupuncture or nontreatment for 12 weeks before controlled ovarian hyperstimulation.,"[{'ForeName': 'Huanfang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Chensi', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': 'Shanxi Provincial Hospital of Chinese Medicine, Taiyuan, Shanxi, China.'}, {'ForeName': 'Huidan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Shandong University Reproductive Hospital, Jinan, Shandong, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sun Yat-sen Memorial Hospital of the Sun Yat-sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': 'Lanzhou University First Hospital, Lanzhou, Gansu, China.'}, {'ForeName': 'Cuilian', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Huazhong University of Science and Technology Reproductive Medicine Center of Tongji Medical College, Wuhan, Hubei, China.'}, {'ForeName': 'Guoqing', 'Initials': 'G', 'LastName': 'Tong', 'Affiliation': 'Shanghai Shuguang Hospital, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'East Region Military Command General Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'Luoyang Women and Children Health Care Center, Luoyang, Henan, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Mingzhao', 'Initials': 'M', 'LastName': 'Hao', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Yaqian', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Yigong', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China. fangyigong@163.com.'}, {'ForeName': 'Baoyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. liuby5505@139.com.'}]",Trials,['10.1186/s13063-020-04690-8']
2702,32912305,A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol.,"BACKGROUND


Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA.
METHODS


The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up.
DISCUSSION


This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient's status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04263974 . Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.",2020,Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment).,"['patients with a chronic rheumatic disease', 'patients with hand RA', 'Fifty-eight participants with hand RA', 'patients with hand rheumatoid arthritis']","['therapeutic exercise and education', 'smartphone app (CareHand), using hand exercises and educational advices', 'Control intervention', 'smartphone app, which provides individualized exercise programs, self-management, and educational strategies', 'control group (conventional treatment']","['overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ', 'self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer', 'overall function, pain intensity, stiffness, and grip and pinch strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4517817', 'cui_str': '58'}]","[{'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}]",58.0,0.081956,Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment).,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rodríguez-Sánchez-Laulhé', 'Affiliation': 'Andalusian Public Foundation for the Management of Health Research of Seville FISEVI, Seville, Spain.'}, {'ForeName': 'Luis Gabriel', 'Initials': 'LG', 'LastName': 'Luque-Romero', 'Affiliation': 'Research Unit, Distrito Sanitario Aljarafe-Sevilla Norte, Servicio Andaluz de Salud, Seville, Spain. luqueluis2@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Blanquero', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Suero-Pineda', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Biscarri-Carbonero', 'Affiliation': 'Research Unit, Distrito Sanitario Aljarafe-Sevilla Norte, Servicio Andaluz de Salud, Seville, Spain.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Barrero-García', 'Affiliation': 'Research Unit, Distrito Sanitario Aljarafe-Sevilla Norte, Servicio Andaluz de Salud, Seville, Spain.'}, {'ForeName': 'Alberto Marcos', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Physiotherapy Department, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain.'}]",Trials,['10.1186/s13063-020-04713-4']
2703,32912308,Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention.,"BACKGROUND


This study reports on qualitative research conducted within a randomised controlled trial to explore possible intervention mechanisms. It focuses on the 'Learning Together' whole-school intervention delivered in secondary schools in England from 2014 to 2017 aiming to prevent bullying and aggression and improve student health. Intervention schools received staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs.
METHODS


Informed by realist approaches to evaluation, we analysed qualitative data to explore intervention mechanisms and how these might interact with school contexts to generate outcomes. Qualitative analysis drew on 45 interviews and 21 focus groups across three case-study schools and employed thematic content analysis to explore how intervention resources were taken up and used by local actors, how participants described the intervention mechanisms that then ensued, and how these might have generated beneficial outcomes.
RESULTS


The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
CONCLUSIONS


Our analysis provides in-depth exploration of possible mechanisms and the contextual contingencies associated with these, allowing refinement of the initial intervention theory of change.
TRIAL REGISTRATION


ISRCTN registry 10751359 . Registered on 11 March 2014.",2020,"The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
",[],"['staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs']",[],[],"[{'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0582589', 'cui_str': 'Emotional learning'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]",[],,0.0292106,"The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community.
","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Warren', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK. emily.warren@lshtm.ac.uk.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Meledez-Torres', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'UCL Institute of Child Health, London, WC1N 1EH, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-020-04688-2']
2704,32911981,Permanent His Bundle Pacing Implantation Facilitated by Visualization of the Tricuspid Valve Annulus.,"Background  - His bundle pacing (HBP) is the most physiologic pacing modality. However, HBP has longer procedure times with frequent high capture thresholds, which likely contributes to the low adoption of this approach. The aim of this study is to compare HBP implantation with a novel imaging technique versus the standard implantation technique.  Methods  - This study included 50 patients with standard pacing indications randomized to HBP with visualization of the tricuspid valve annulus (TVA, N=25, the visualization group) or with the standard method (N=25, the control group). In the visualization group, the TVA was imaged by contrast injection in the right ventricle during fluoroscopy. The site for HBP was identified in relationship to the tricuspid septal leaflet and interventricular septum.  Results  - Permanent HBP was successful in 92% in the visualization group and 88% in the control group. The fluoroscopic time for HBP lead placement was significantly shorter in the visualization group (7.1±3.3min) compared with the control group (10.1±5.6min, P=0.03). Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively). There was no significant difference in capture threshold between groups. In the visualization group, there was a quantitative association between the HBP site and the TVA.  Conclusions  - The visualization technique shortens the procedural and fluoroscopic times for HBP implantation. Moreover, anatomic localization of HBP sites is strongly associated with physiologic characteristics of pacing, which can help guide optimal lead placement.",2020,"Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively).",['50 patients with standard pacing indications randomized to'],"['HBP implantation with a novel imaging technique versus the standard implantation technique', 'TVA', 'His bundle pacing (HBP', 'HBP with visualization of the tricuspid valve annulus (TVA, N=25, the visualization group) or with the standard method', 'HBP']","['fluoroscopic time for HBP lead placement', 'Total procedural and fluoroscopic times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0225926', 'cui_str': 'Structure of anulus fibrosus of tricuspid orifice'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",50.0,0.0224901,"Total procedural and fluoroscopic times were also significantly shorter in the visualization group (91.0±15.7min and 9.6±3.8min) than the control group (104.4±17.8min and 12.7±6.2min, P=0.01 and 0.04, respectively).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Niu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Yiran', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Nixiao', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Minsi', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Xuhua', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Cardiac Rhythm Heart Failure, Medtronic, plc., Minneapolis, MN.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Gold', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hua', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'The Cardiac Arrhythmia Center, State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Diseases, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College. Beijing, China.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008370']
2705,32911988,Effects of High-Dose Vitamin D Supplementation on Phase Angle and Physical Function in Patients with Prostate Cancer on ADT.,"PURPOSE


Androgen deprivation therapy (ADT) is commonly used to treat patients with advanced prostate cancer but is associated with functional decline. Bioelectrical impedance analysis (BIA)-derived phase angle may reflect frailty and functional decline in cancer patients. High-dose vitamin D supplementation may improve phase angle values and physical function.
METHODS


We conducted an exploratory analysis from a phase II randomized controlled trial investigating the efficacy of high-dose vitamin D supplementation in prostate cancer patients (age ≥ 60 yrs). Fifty-nine patients were randomized to high-dose vitamin D (600 IU/day plus 50,000 IU/week) or low-dose: RDA for vitamin D (600 IU/day plus placebo weekly) for 24 weeks. Phase angle was measured by BIA. Physical function measures included handgrip strength, 6-minute walk test, Short Performance Physical Battery and leg extension. All testing was completed at baseline, week 12 and week 24.
RESULTS


Phase angle values were wider over the entire study in the high-dose vitamin D arm indicating healthier muscle cells. The low-dose vitamin D arm had phase angle values consistent with frailty cutoffs in older men (<5.7°).
CONCLUSION


Patients in the high-dose vitamin D arm experienced wider phase angle values over the course of the study which may indicate less frailty. ClinicalTrials.gov ID: NCT02064946.",2020,"RESULTS


Phase angle values were wider over the entire study in the high-dose vitamin D arm indicating healthier muscle cells.","['older men (<5.7°', 'patients with advanced prostate cancer', 'Fifty-nine patients', 'prostate cancer patients (age ≥ 60 yrs', 'Patients with Prostate Cancer on ADT', 'cancer patients']","['RDA for vitamin D', 'vitamin D', 'High-dose vitamin D supplementation', 'Androgen deprivation therapy (ADT', 'high-dose vitamin D supplementation', 'High-Dose Vitamin D Supplementation']","['handgrip strength, 6-minute walk test, Short Performance Physical Battery and leg extension', 'Phase Angle and Physical Function']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowance'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",59.0,0.352517,"RESULTS


Phase angle values were wider over the entire study in the high-dose vitamin D arm indicating healthier muscle cells.","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Inglis', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Isabel D', 'Initials': 'ID', 'LastName': 'Fernandez', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'van Wijngaarden', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Reschke', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Kleckner', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Po-Ju', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Peppone', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, New York, USA.'}]",Nutrition and cancer,['10.1080/01635581.2020.1819348']
2706,32912051,A Pilot Randomized Controlled Trial Using SystemCHANGE Approach to Increase Physical Activity in Older Kidney Transplant Recipients.,"BACKGROUND


Cardiovascular disease is the leading cause of death in kidney transplant recipients. Physical activity after transplant is the most modifiable nonpharmacological factor for improving cardiovascular outcomes. Few studies have tested walking interventions to enhance daily steps and health outcomes in older kidney recipients.
METHODS


Using a pilot feasibility randomized clinical trial design, we tested the feasibility and efficacy of a 6-month SystemCHANGE (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention for recruitment, retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function). The SystemCHANGE + Activity Tracker intervention taught participants to use a multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker to achieve daily step goals.
RESULTS


Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group. The study protocol was feasible to deliver with high adherence to the protocol in both groups. The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283,  P  = .03) compared to the control group. The secondary outcome of heart rate decreased for the intervention group (baseline [mean] 74.4+ 10.8 [standard deviation, SD;] vs 6 months [mean] 67.6+ 11.3 [SD];  P  = .002) compared to the control group (baseline [mean] 70.67+ 10.4 [SD]; vs 6 months [mean] 70.2 + 11.1 [SD];  P  = .83).
CONCLUSIONS


SystemCHANGE + Activity Tracker intervention appears to be feasible and efficacious for increasing daily steps in older kidney recipients.",2020,"The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283,  P  = .03) compared to the control group.","['Fifty-three participants (mean age 65 years, 66% male, and 57% white) participated with 27 in the intervention and 26 in the control group', 'Older Kidney Transplant Recipients', 'kidney transplant recipients', 'older kidney recipients']","['SystemCHANGE + Activity Tracker intervention', 'multicomponent intervention that connects person-centered systems solutions combined with visual feedback from a mobile activity tracker', '6-month SystemCHANGE (Change Habits by Applying New Goals and Experience) + Activity Tracker intervention']","['retention, daily steps, and health outcomes (blood pressure, heart rate, body mass index, waist circumference, and physical function', 'daily steps', 'feasibility and efficacy', 'Physical Activity', 'Physical activity', 'heart rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0584483,"The intervention group increased daily steps at 3 months (mean difference, 608; standard error = 283,  P  = .03) compared to the control group.","[{'ForeName': 'Tara', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Russell', 'Affiliation': 'School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Mion', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'The Ohio State University College of Nursing, Columbus, OH, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Focht', 'Affiliation': 'The Ohio State University College of Education and Human Ecology, Columbus, OH, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Daloul', 'Affiliation': 'The Ohio State University College of Medicine, Columbus, OH, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Hathaway', 'Affiliation': 'University of Tennessee Health Science Center College of Nursing Memphis, TN, USA.'}]","Progress in transplantation (Aliso Viejo, Calif.)",['10.1177/1526924820958148']
2707,32912058,Post-Stroke Depressive Symptoms: Varying Responses to Escitalopram by Individual Symptoms and Lesion Location.,"OBJECTIVE


The efficacy of antidepressants in post-stroke depressive symptoms (PSD) varies. We aimed to examine whether the effect of escitalopram on PSD differs according to individual depressive symptoms and stroke lesion location.
METHODS


This is a post hoc analysis of EMOTION (ClinicalTrials.gov, NCT01278498), a randomized, placebo-controlled, double-blind trial that examined the efficacy of escitalopram on depression in acute stroke patients (237 with placebo, 241 with escitalopram). Depressive symptoms were evaluated with the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS). Changes in MADRS and individual item scores at 12 weeks were compared between the treatment groups and among the stroke lesion location groups. Stroke lesion locations were grouped according to the anatomical distribution of serotonin fibers that originate from the midbrain/pons and spread to the forebrain via subcortical structures: ""Midbrain-Pons,"" ""Frontal-Subcortical,"" and ""Others."" Least-squares means were calculated to demonstrate the independent effect of lesion location.
RESULTS


Total MADRS scores decreased more significantly in the escitalopram than in the placebo group, while a significant effect of escitalopram was observed in only 3 items: apparent sadness, reported sadness, pessimistic thoughts. In the lesion location analyses, escitalopram users in the Frontal-Subcortical group showed significant improvement in total MADRS scores (placebo [n = 130] vs. escitalopram [n = 148], least-square mean [95% CI]: -2.3 [-3.5 to -0.2] vs. -4.5 [-5.5 to -3.4], p = .005), while those in the Midbrain-Pons and Others groups did not.
CONCLUSIONS


The effect of escitalopram on PSD may be more prominent in patients with particular depressive symptoms and stroke lesion locations, suggesting the need for tailored treatment strategies.",2020,Changes in MADRS and individual item scores at 12 weeks were compared between the treatment groups and among the stroke lesion location groups.,"['acute stroke patients (237 with placebo, 241 with escitalopram', 'patients with particular depressive symptoms and stroke lesion locations']","['antidepressants', 'placebo', 'escitalopram']","['Changes in MADRS and individual item scores', 'escitalopram', 'total MADRS scores', 'Total MADRS scores', 'Depressive symptoms', '10-item Montgomery-Åsberg Depression Rating Scale (MADRS']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",,0.369838,Changes in MADRS and individual item scores at 12 weeks were compared between the treatment groups and among the stroke lesion location groups.,"[{'ForeName': 'Eun-Jae', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Jong S', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of Ulsan, Asan Medical Center, Seoul, Korea.'}, {'ForeName': 'Dae-Il', 'Initials': 'DI', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, KyungHee University, Seoul, Korea.'}, {'ForeName': 'Jong-Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Myongji Hospital, Goyang, Korea.'}, {'ForeName': 'Seong Hwan', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Neurology, Chosun University, Gwangju, Korea.'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Neurology, Dong-A University Busan, Korea.'}, {'ForeName': 'Ji Hoe', 'Initials': 'JH', 'LastName': 'Heo', 'Affiliation': 'Department of Neurology, Yonsei University, Seoul, Korea.'}, {'ForeName': 'Sung-Il', 'Initials': 'SI', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Keimyung University, Daegu, Korea.'}, {'ForeName': 'Byung-Chul', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Hallym University, Pyungchon, Korea.'}, {'ForeName': 'Dong-Eog', 'Initials': 'DE', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Dongguk University, Goyang, Korea.'}, {'ForeName': 'Hahn Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Konkuk University, Seoul, Korea.'}, {'ForeName': 'Seongheon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Kangwon National University, Chuncheon, Korea.'}, {'ForeName': 'Do-Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Department of Neurology, Korea University, Ansan, Korea.'}, {'ForeName': 'Jei', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Chungnam University, Daejeon, Korea.'}, {'ForeName': 'Woo-Keun', 'Initials': 'WK', 'LastName': 'Seo', 'Affiliation': 'Department of Neurology, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yeungnam University, Daegu, Korea.'}, {'ForeName': 'Sang-Won', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Neurology, Daegu Fatima Hospital, Daegu, Korea.'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Koh', 'Affiliation': 'Department of Neurology, Hanyang University, Guri, Korea.'}, {'ForeName': 'Jin Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Hyundai Hospital, Eumseong, Korea.'}, {'ForeName': 'Smi', 'Initials': 'S', 'LastName': 'Choi-Kwon', 'Affiliation': 'College of Nursing, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Min-Sun', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'College of Medicine, Michigan State University, MI, USA.'}, {'ForeName': 'Ji-Sung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Center, Asan Medical Center, Seoul, Korea.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988720957108']
2708,32912199,The effect on work presenteeism of job retention vocational rehabilitation compared to a written self-help work advice pack for employed people with inflammatory arthritis: protocol for a multi-centre randomised controlled trial (the WORKWELL trial).,"BACKGROUND


Work problems are common in people with inflammatory arthritis. Up to 50% stop work within 10 years due to their condition and up to 67% report presenteeism (i.e. reduced work productivity), even amongst those with low disease activity. Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations. This aims to create a better match between the person's abilities and their job demands. The objectives of the Workwell trial are to test the overall effectiveness and cost-effectiveness of JRVR (WORKWELL) provided by additionally trained National Health Service (NHS) occupational therapists compared to a control group who receive self-help information both in addition to usual care.
METHODS


Based on the learning from a feasibility trial (the WORK-IA trial: ISRCTN76777720 ), the WORKWELL trial is a multi-centre, pragmatic, individually-randomised parallel group superiority trial, including economic evaluation, contextual factors analysis and process evaluation. Two hundred forty employed adults with rheumatoid arthritis, undifferentiated inflammatory arthritis or psoriatic arthritis (in secondary care), aged 18 years or older with work instability will be randomised to one of two groups: a self-help written work advice pack plus usual care (control intervention); or WORKWELL JRVR plus a self-help written work advice pack and usual care. WORKWELL will be delivered by occupational therapists provided with additional JRVR training from the research team. The primary outcome is presenteeism as measured using the Work Limitations Questionnaire-25. A comprehensive range of secondary outcomes of work, health, contextual factors and health resource use are included. Outcomes are measured at 6- and 12- months (with 12-months as the primary end-point). A multi-perspective within-trial cost-effectiveness analyses will also be conducted.
DISCUSSION


This trial will contribute to the evidence base for provision of JRVR to people with inflammatory arthritis. If JRVR is found to be effective in enabling people to keep working, the findings will support decision-making about provision of JRVR by rheumatology teams, therapy services and healthcare commissioners, and providing evidence of the effectiveness of JRVR and the economic impact of its implementation.
TRIAL REGISTRATION


Clinical Trials.Gov: NCT03942783 . Registered 08/05/2019 ( https://clinicaltrials.gov/ct2/show/NCT03942783 ); ISRCTN Registry: ISRCTN61762297 . Registered:13/05/2019 ( http://www.isrctn.com/ISRCTN61762297 ). Retrospectively registered.",2020,"Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations.","['Two hundred forty employed adults with rheumatoid arthritis, undifferentiated inflammatory arthritis or psoriatic arthritis (in secondary care), aged 18\u2009years or older with work instability', 'employed people with inflammatory arthritis', 'people with inflammatory arthritis']","['self-help written work advice pack plus usual care (control intervention); or WORKWELL JRVR plus a self-help written work advice pack and usual care', 'Job retention vocational rehabilitation (JRVR', 'written self-help work advice pack', 'JRVR', 'job retention vocational rehabilitation']",['presenteeism as measured using the Work Limitations Questionnaire-25'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1562028', 'cui_str': 'Undifferentiated inflammatory arthritis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation'}]","[{'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",240.0,0.196277,"Job retention vocational rehabilitation (JRVR) may help prevent or postpone job loss and reduce presenteeism through work assessment, work-related rehabilitation and enabling job accommodations.","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hammond', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK. a.hammond@salford.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Sutton', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cotterill', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Woodbridge', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Brien"", 'Affiliation': 'School of Health and Wellbeing, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Radford', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Forshaw', 'Affiliation': 'Lancashire Clinical Trials Unit, University of Central Lancashire, Brook Building, Preston, Lancashire, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Verstappen', 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Marsden', 'Affiliation': 'Centre for Biostatistics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eden', 'Affiliation': 'Manchester Centre for Health Economics, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Prior', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Culley', 'Affiliation': 'Patient research partner, Derbyshire, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Holland', 'Affiliation': 'Division of Health Research, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Walker-Bone', 'Affiliation': 'MRC Versus Arthritis Centre for Musculoskeletal Health and Work, University of Southampton, Southampton, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Hough', 'Affiliation': 'Rheumatology/ Occupational Therapy, St Helens and Knowsley Teaching Hospitals NHS Foundation Trust, St Helens Hospital, St Helens, Merseyside, UK.'}, {'ForeName': 'Terence W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ching', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Centre for Health Sciences Research, University of Salford, Allerton L701, Frederick Road, Salford, Greater Manchester, M6 6PU, UK.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03619-1']
2709,32912218,Effectiveness of a health-social partnership program for discharged non-frail older adults: a pilot study.,"BACKGROUND


Previous studies supporting discharged patients are hospital-based which admission criteria tend to include mainly those with complex needs and/or specific disease conditions. This study captured the service gap where these non-frail older patients might have no specific medical problem upon discharge but they might encounter residual health and social issues when returning home.
METHODS


Discharged community-dwelling non-frail older adults from an emergency medical ward were recruited and randomized into either intervention (n = 37) or control (n = 38) group. The intervention group received a 12-week complex interventions that included structured assessment, health education, goal empowerment, and care coordination supported by a health-social team. The control group received usual discharge care and monthly social call. The primary outcome was health-related quality of life (HRQoL). Secondary outcomes included activities of daily living (ADL), the presence of depressive symptoms, and the use of health services. The outcomes were measured at pre-intervention (T1) and at three months post-intervention (T2). The independent t-test or the Mann-Whitney U test was used to analyze the group differences in HRQoL, ADL, and presence of depressive symptoms according to the normality of data.
RESULTS


Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1. No significant differences were found in the control group.
CONCLUSIONS


Supporting self-care is necessary to enable community-dwelling non-frail older adults to be independent to the fullest extent possible in the community. The promising results found in this pilot study suggested that the integration of the health-social partnership into transitional care practice is effective and can be sustained in the community. Future studies can draw on these findings and maximize the integrated care quality during the transition phase.
TRIAL REGISTRATION


NCT04434742 (date: 17 June 2020, retrospectively registered).",2020,"RESULTS


Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1.","['Discharged community-dwelling non-frail older adults from an emergency medical ward', 'community-dwelling non-frail older adults', 'frail older patients', '17 June 2020, retrospectively registered', 'discharged non-frail older adults']","['health-social partnership program', 'usual discharge care and monthly social call', '12-week complex interventions that included structured assessment, health education, goal empowerment, and care coordination supported by a health-social team']","['HRQoL, ADL, and presence of depressive symptoms', 'activities of daily living', 'mental component scale of quality of life', 'health-related quality of life (HRQoL', 'presence of depressive symptoms', 'activities of daily living (ADL), the presence of depressive symptoms, and the use of health services']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0505116,"RESULTS


Analysis showed that the intervention group experienced a statistically significantly improvement in the mental component scale of quality of life (p = .036), activities of daily living (p = .005), and presence of depressive symptoms (p = .035) at T2 compared with at T1.","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong. frances.wong@polyu.edu.hk.'}, {'ForeName': 'Jenny Sau Chun', 'Initials': 'JSC', 'LastName': 'Ngai', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}, {'ForeName': 'Shirley Yu Kan', 'Initials': 'SYK', 'LastName': 'Hung', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}, {'ForeName': 'Wah Chun', 'Initials': 'WC', 'LastName': 'Li', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon Central Cluster, Hong Kong Hospital Authority, Kowloon, Hong Kong.'}]",BMC geriatrics,['10.1186/s12877-020-01722-5']
2710,32912260,Leveraging family dynamics to increase the effectiveness of incentives for physical activity: the FIT-FAM randomized controlled trial.,"BACKGROUND


Insufficient physical activity is a global public health concern. Research indicates incentives can increase physical activity levels of children but has not tested whether incentives targeted at children can be leveraged to increase physical activity levels of their parents. This study evaluates whether a novel incentive design linking children's incentives to both their and their parent's physical activity levels can increase parent's physical activity.
METHODS


We conducted a two-arm, parallel, open-labelled randomized controlled trial in Singapore where parent-child dyads were randomly assigned to either (1) rewards to child contingent on child's physical activity (child-based) or (2) rewards to child contingent on both child's and parent's physical activity (family-based). Parents had to be English-speaking, computer-literate, non-pregnant, full-time employees, aged 25-65 years, and with a participating child aged 7-11 years. Parent-child dyads were randomized within strata (self-reported low vs high weekly physical activity) into study arms in a 1:1 ratio. Participants were given activity trackers to assess daily steps. The outcome of interest was the between-arm difference in the change from baseline in parent's mean steps/day measured by accelerometry at months 6 and 12 (primary endpoint).
RESULTS


Overall, 159 and 157 parent-child dyads were randomized to the child-based or family-based arms, respectively. Outcomes were evaluated on an intent-to-treat basis. At month 6, there was a 613 steps/day (95% CI: 54-1171) differential in favour of family-based parents. At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
CONCLUSIONS


Our findings suggest that novel incentive designs that take advantage of group dynamics may be effective. However, in this design, the effectiveness of the family-based incentive to increase parent's physical activity was not sustained through one year.
TRIAL REGISTRATION


NCT02516345 (ClinicalTrials.gov) registered on August 5, 2015.",2020,"At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
","['Parents had to be English-speaking, computer-literate, non-pregnant, full-time employees, aged 25-65\u2009years, and with a participating child aged 7-11\u2009years', 'Singapore where parent-child dyads', '159 and 157 parent-child dyads', 'Parent-child dyads']","[""1) rewards to child contingent on child's physical activity (child-based) or (2) rewards to child contingent on both child's and parent's physical activity (family-based""]","[""parent's physical activity"", 'physical activity levels']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.111529,"At month 12, our primary endpoint, the differential was reduced to 369 steps/day (95% CI: - 88-1114) and was no longer statistically significant.
","[{'ForeName': 'Eric Andrew', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. eric.finkelstein@duke-nus.edu.sg.'}, {'ForeName': 'Robyn Su May', 'Initials': 'RSM', 'LastName': 'Lim', 'Affiliation': 'Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.'}, {'ForeName': 'Dianne Stanton', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina Chapel Hill, 1700 Martin Luther King Jr. Boulevard #7426, Chapel Hill, NC, 27514, USA.'}, {'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Evenson', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina Chapel Hill, 1700 Martin Luther King Jr. Boulevard #7426, Chapel Hill, NC, 27514, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01018-2']
2711,32912290,Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial.,"BACKGROUND


Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets. Ibudilast, a phosphodiesterase inhibitor, has been advanced as a novel addiction pharmacotherapy that targets neurotrophin signaling and neuroimmune function.
METHODS


This study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50 mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, percent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in to a neuroimaging session in which we examine the effects of ibudilast on neural activation to psychosocial stress and alcohol cues. Finally, we will also collect plasma levels of proinflammatory markers, as well as subjective and biological (salivary cortisol) markers of stress response.
DISCUSSION


This study will further develop ibudilast, a safe and promising novel compound with strong preclinical and clinical safety data for AUD, and will probe biological mechanisms underlying the effects of Ibudilast on stress, neuroinflammation, and alcohol cue-reactivity and craving. If ibudilast proves superior to placebo in this study, it will set the stage for a confirmatory multi-site trial leading to FDA approval of a novel AUD treatment.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03594435 ""Ibudilast for the Treatment of Alcohol Use Disorder"". Registered on 20 July 2018.",2020,The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets.,['132 treatment-seeking men and women with current AUD'],"['ibudilast (50\u2009mg BID', 'placebo']","['subjective and biological (salivary cortisol) markers of stress response', 'alcohol craving and negative mood', 'heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0123047', 'cui_str': 'ibudilast'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439505', 'cui_str': '/day'}]",,0.0733362,The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets.,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Burnette', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA. eburnette@g.ucla.edu.'}, {'ForeName': 'Wave-Ananda', 'Initials': 'WA', 'LastName': 'Baskerville', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.'}]",Trials,['10.1186/s13063-020-04670-y']
2712,32912441,Nonculprit Lesion Severity and Outcome of Revascularization in Patients With STEMI and Multivessel Coronary Disease.,"BACKGROUND


In the COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial, angiography-guided percutaneous coronary intervention (PCI) of nonculprit lesions with the aim of complete revascularization reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (MI) and multivessel coronary artery disease.
OBJECTIVES


The purpose of this study was to determine the effect of nonculprit-lesion stenosis severity measured by quantitative coronary angiography (QCA) on the benefit of complete revascularization.
METHODS


Among 4,041 patients randomized in the COMPLETE trial, nonculprit lesion stenosis severity was measured using QCA in the angiographic core laboratory in 3,851 patients with 5,355 nonculprit lesions. In pre-specified analyses, the treatment effect in patients with QCA stenosis ≥60% versus <60% on the first coprimary outcome of CV death or new MI and the second co-primary outcome of CV death, new MI, or ischemia-driven revascularization was determined.
RESULTS


The first coprimary outcome was reduced with complete revascularization in the 2,479 patients with QCA stenosis ≥60% (2.5%/year vs. 4.2%/year; hazard ratio [HR]: 0.61; 95% confidence interval [CI]: 0.47 to 0.79), but not in the 1,372 patients with QCA stenosis <60% (3.0%/year vs. 2.9%/year; HR: 1.04; 95% CI: 0.72 to 1.50; interaction p = 0.02). The second coprimary outcome was reduced in patients with QCA stenosis ≥60% (2.9%/year vs. 6.9%/year; HR: 0.43; 95% CI: 0.34 to 0.54) to a greater extent than patients with QCA stenosis <60% (3.3%/year vs. 5.2%/year; HR: 0.65; 95% CI: 0.47 to 0.89; interaction p = 0.04).
CONCLUSIONS


Among patients with ST-segment elevation MI and multivessel coronary artery disease, complete revascularization reduced major CV outcomes to a greater extent in patients with stenosis severity of ≥60% compared with <60%, as determined by quantitative coronary angiography.",2020,"Among patients with ST-segment elevation MI and multivessel coronary artery disease, complete revascularization reduced major CV outcomes to a greater extent in patients with stenosis severity of ≥60% compared with <60%, as determined by quantitative coronary angiography.","['3,851 patients with 5,355 nonculprit lesions', 'patients with ST-segment elevation myocardial infarction (MI) and multivessel coronary artery disease', 'Patients With STEMI and Multivessel Coronary Disease', 'patients with ST-segment elevation MI and multivessel coronary artery disease', '2,479 patients with QCA stenosis\xa0≥60% (2.5%/year vs. 4.2%/year; hazard ratio [HR', '4,041 patients']","['angiography-guided percutaneous coronary intervention (PCI', 'nonculprit-lesion stenosis severity measured by quantitative coronary angiography (QCA']","['patients with QCA stenosis', 'CV death or new MI and the second co-primary outcome of CV death, new MI, or ischemia-driven revascularization', 'nonculprit lesion stenosis severity', 'major cardiovascular (CV) events', 'complete revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0010068', 'cui_str': 'Coronary Heart Disease'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",3851.0,0.107423,"Among patients with ST-segment elevation MI and multivessel coronary artery disease, complete revascularization reduced major CV outcomes to a greater extent in patients with stenosis severity of ≥60% compared with <60%, as determined by quantitative coronary angiography.","[{'ForeName': 'Tej', 'Initials': 'T', 'LastName': 'Sheth', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: https://twitter.com/PHRIresearch.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Pinilla-Echeverri', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'University Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wood', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity, and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Bainey', 'Affiliation': 'University of Alberta, Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bossard', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'Jon-David', 'Initials': 'JD', 'LastName': 'Schwalm', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Velianou', 'Affiliation': 'McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Valettas', 'Affiliation': 'McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sibbald', 'Affiliation': 'McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Rodés-Cabau', 'Affiliation': 'Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ducas', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Cohen', 'Affiliation': 'Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Bagai', 'Affiliation': ""Terrence Donnelly Heart Centre, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Rinfret', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Feldman', 'Affiliation': 'Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Laster', 'Affiliation': ""St. Luke's Mid-America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri.""}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Lang', 'Affiliation': 'Vienna General Hospital, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Mills', 'Affiliation': 'Liverpool Heart and Chest Hospital, Liverpool, United Kingdom.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cairns', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'Population Health Research Institute, Hamilton, Ontario, Canada; McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: https://twitter.com/PHRIresearch.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.07.034']
2713,32912445,Impact of Tricuspid Regurgitation on Clinical Outcomes: The COAPT Trial.,"BACKGROUND


The presence of tricuspid regurgitation (TR) may affect prognosis in patients with mitral regurgitation (MR).
OBJECTIVES


This study sought to determine the impact of TR on outcomes in patients with heart failure and severe secondary MR randomized to guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip in the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial.
METHODS


A total of 614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR were randomized to maximally tolerated GDMT plus MitraClip or GDMT alone; 599 had core laboratory evaluable echocardiograms. Patients were divided into 2 groups by baseline TR severity: none/trace/mild TR (≤Mild TR) (n = 501 [83.6%]) and moderate/severe TR (≥Mod TR) (n = 98 [16.4%]). Two-year composite endpoints of death or heart failure hospitalization (HFH) and the individual endpoints were analyzed.
RESULTS


Patients with ≥Mod TR were more likely to be New York Heart Association functional class III/IV (p < 0.0001) and have a Society of Thoracic Surgeons score of ≥8 (p < 0.0001), anemia (p = 0.02), chronic kidney disease (p = 0.003), and higher N-terminal pro-B-type natriuretic peptide (p = 0.02) than those with ≤Mild TR. Patients with ≥Mod TR had more severe MR (p = 0.0005) despite smaller left ventricular volumes (p = 0.005) and higher right ventricular systolic pressure (p < 0.0001). At 2 years, the composite rate of death or HFH was higher in patients with ≥Mod TR compared with ≤Mild TR treated with GDMT alone (83.0% vs. 64.3%; hazard ratio: 1.74; 95% confidence interval: 1.24 to 2.45; p = 0.001) but not following MitraClip (48.2% vs. 44.0%; hazard ratio: 1.14; 95% confidence interval: 0.71 to 1.84; p = 0.59). Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (p interaction  = 0.16, 0.29, and 0.21 respectively).
CONCLUSIONS


Patients with severe secondary MR who also had ≥Mod TR had worse clinical and echocardiographic characteristics and worse clinical outcomes compared to those with ≤Mild TR. Within the COAPT trial, MitraClip improved outcomes in patients with and without ≥Mod TR severity compared with GDMT alone. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [COAPT]; NCT01626079).",2020,"Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (p interaction  = 0.16, 0.29, and 0.21 respectively).
","['Heart\xa0Failure Patients With Functional Mitral\xa0Regurgitation\xa0[COAPT', 'Patients with severe secondary MR who also had\xa0≥Mod', 'patients with mitral regurgitation (MR', 'Failure Patients With Functional Mitral Regurgitation) trial', '614 patients with symptomatic heart failure with moderate to severe (3+) or severe (4+) secondary MR', 'Patients with\xa0≥Mod', 'patients with heart failure and severe secondary MR randomized to', 'alone; 599 had core laboratory evaluable echocardiograms']","['≤Mild', 'MitraClip Percutaneous Therapy for Heart', 'TR', 'MitraClip Percutaneous Therapy', 'maximally tolerated GDMT plus MitraClip or GDMT', 'GDMT', 'guideline-directed medical therapy (GDMT) or edge-to-edge repair with the MitraClip']","['composite rate of death or HFH', 'severe MR', 'anemia', 'clinical and echocardiographic characteristics', 'smaller left ventricular volumes', 'higher right ventricular systolic pressure', 'chronic kidney disease', 'Rates of death or HFH', 'Clinical Outcomes', 'Society of Thoracic Surgeons score of', 'death or heart failure hospitalization (HFH) and the individual endpoints']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026266', 'cui_str': 'Mitral valve regurgitation'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456181', 'cui_str': 'Right ventricular systolic pressure'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",614.0,0.250809,"Rates of death or HFH, as well as death and HFH alone, were reduced by MitraClip compared with GDMT, irrespective of baseline TR grade (p interaction  = 0.16, 0.29, and 0.21 respectively).
","[{'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': 'Columbia University Medical Center, New York Presbyterian Hospital, New York, New York. Electronic address: rth2@columbia.edu.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Asch', 'Affiliation': 'Medstar Health Research Institute, Washington, DC.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': 'Medstar Health Research Institute, Washington, DC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Grayburn', 'Affiliation': 'Baylor Scott & White Health, Plano, Texas.'}, {'ForeName': 'Saibal', 'Initials': 'S', 'LastName': 'Kar', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Columbia University Medical Center, New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Medvedofsky', 'Affiliation': 'Medstar Health Research Institute, Washington, DC.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Puri', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sannino', 'Affiliation': 'Baylor Scott & White Health, Plano, Texas.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Ohio State University Medical Center, Columbus, Ohio.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mack', 'Affiliation': 'Baylor Scott & White Health, Plano, Texas.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.07.035']
2714,32912462,Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate-Guided Hydration in Preventing Contrast-Associated Acute Kidney Injury.,"OBJECTIVES


This study compared left ventricular end-diastolic pressure (LVEDP)-guided and urine flow rate (UFR)-guided hydration.
BACKGROUND


Tailored hydration regimens improve the prevention of contrast-associated acute kidney injury (CA-AKI).
METHODS


Between July 15, 2015, and June 6, 2019, patients at high risk for CA-AKI scheduled for coronary and peripheral procedures were randomized to 2 groups: 1) normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR ≥300 ml/h (UFR-guided group). The primary endpoint was the composite of CA-AKI (i.e., serum creatinine increase ≥25% or ≥0.5 mg/dl at 48 h) and acute pulmonary edema (PE). Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury) at 1 month were assessed.
RESULTS


The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036). CA-AKI and PE rates in the UFR-guided group and LVEDP-guided group were 5.7% and 10.0% (RR: 0.570; 95% CI: 0.300 to 0.960; p = 0.048), and, respectively, 0.3% and 2.0% (RR: 0.070; 95% CI: 0.020 to 1.160; p = 0.069). Three patients in the UFR-guided group experienced complications related to the Foley catheter. Hypokalemia rate was 6.2% in the UFR-guided group and 2.3% in the LVEDP-guided group (p = 0.013). The 1-month major adverse events rate was 7.1% in the UFR-guided group and 12.0% in the LVEDP-guided group (p = 0.030).
CONCLUSIONS


The study demonstrates that UFR-guided hydration is superior to LVEDP-guided hydration to prevent the composite of CA-AKI and PE.",2020,The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036).,"['Between July 15, 2015, and June 6, 2019', 'patients at high risk for CA-AKI scheduled for coronary and peripheral procedures']","['Left Ventricular End-Diastolic Pressure Versus Urine Flow Rate-Guided Hydration', 'normal saline infusion rate adjusted according to the LVEDP (LVEDP-guided group); and 2) hydration controlled by the RenalGuard System in order to reach UFR\xa0≥300\xa0ml/h (UFR-guided group']","['left ventricular end-diastolic pressure (LVEDP)-guided and urine flow rate', 'Major adverse events (all-cause death, renal failure requiring dialysis, PE, and sustained kidney injury', 'CA-AKI and PE rates', '1-month major adverse events rate', 'Hypokalemia rate', 'acute pulmonary edema (PE', 'composite of CA-AKI (i.e., serum creatinine increase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439391', 'cui_str': 'mL/h'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0155919', 'cui_str': 'Acute pulmonary edema'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0700225', 'cui_str': 'Serum creatinine raised'}]",,0.03807,The primary endpoint occurred in 20 of 351 (5.7%) patients in the UFR-guided group and in 36 of 351 (10.3%) patients in the LVEDP-guided group (relative risk [RR]: 0.560; 95% confidence interval [CI]: 0.390 to 0.790; p = 0.036).,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy. Electronic address: carlobriguori@clinicamediterranea.it.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': ""D'Amore"", 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Micco', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Signore', 'Affiliation': 'Interventional Cardiology Unit, Policlinico di Bari, Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Science, Division of Cardiology, ""Federico II"" University of Naples, Naples, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Visconti', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Airoldi', 'Affiliation': 'Interventional Cardiology Unit, Istituto di Ricerca a Carattere Scientifico Multimedica MultiMedica, Sesto San Giovanni, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Signoriello', 'Affiliation': 'Department of Mental Health and Preventive Medicine, Second University of Naples, Naples, Italy.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Focaccio', 'Affiliation': 'Interventional Cardiology Unit, Mediterranea Cardiocentro, Naples, Italy.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.04.051']
2715,32912508,"Rationale and Design of a Randomized, Double-Blind Trial Evaluating the Efficacy of Tranexamic Acid on Hematoma Expansion and Peri-hematomal Edema in Patients with Spontaneous Intracerebral Hemorrhage within 4.5 h after Symptom Onset: The THE-ICH Trial Protocol.","BACKGROUND


Hematoma expansion (HE) and peri-hematomal edema (PHE) are associated with adverse outcomes of patients with acute spontaneous intracerebral hemorrhage (sICH). Due to a lack of proven treatments, it is critical to explore novel treatments for HE and PHE to improve functional recovery after sICH.
METHODS


This is a prospective, multicenter, placebo-controlled, double-blind, and randomized clinical study of approximately 2400 patients with sICH. Patients within 4.5 h of sICH onset that fulfilling the clinical criteria for diagnosis (e.g. age more than 18 years old, the Glasgow Coma Scal>7, and no planned surgery) will randomly receive either intravenous tranexamic acid (TXA) 1 g 10-min bolus followed by 1 g eight-hour infusion or placebo (sodium chloride 0.9%). Clinical data including the ICH score and the Glasgow Coma Scale score will be collected on admission. After assessment of HE and PHE expansion, follow-up will be conducted with enrolled patients for 90 days.
RESULTS


Primary outcome metrics are HE (defined as either >33% or >6 ml increase from baseline) and PHE expansion rate at 24 ± 3 h and 72 ± 3 h post-sICH. Secondary outcome metrics include mortality and the modified Rankin Scale on day 90 after sICH. Appropriate statistic methods will be used to evaluate the efficacy of TXA on patients with sICH within 4.5 h of symptom onset.
CONCLUSIONS


HE usually occurs within the first few hours after onset of symptoms. It is essential to evaluate the efficacy of TXA on HE within a narrow window of time. This will be the first trial to evaluate the efficacy of TXA on HE and PHE expansion in sICH patients within 4.5 h after symptom onset. This trial is registered as ChiCTR1900027065 at http://www.chictr.org.cn.",2020,This will be the first trial to evaluate the efficacy of TXA on HE and PHE expansion in sICH patients within 4.5 h after symptom onset.,"['Patients with Spontaneous Intracerebral Hemorrhage within 4.5\xa0h after Symptom Onset', 'patients with sICH within 4.5\xa0h of symptom onset', 'Patients within 4.5\xa0h of sICH onset that fulfilling the clinical criteria for diagnosis (e.g. age more than 18 years old, the Glasgow Coma Scal>7, and no planned surgery', 'patients with acute spontaneous intracerebral hemorrhage (sICH', 'sICH patients within 4.5\xa0h after symptom onset', 'approximately 2400 patients with sICH']","['intravenous tranexamic acid (TXA', 'Tranexamic Acid', 'placebo', 'TXA', 'placebo (sodium chloride 0.9']","['HE', 'mortality and the modified Rankin Scale on day 90 after sICH', 'Hematoma Expansion and Peri-hematomal Edema', 'ICH score and the Glasgow Coma Scale score', 'HE and PHE expansion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517656', 'cui_str': '2400'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}]",2400.0,0.270154,This will be the first trial to evaluate the efficacy of TXA on HE and PHE expansion in sICH patients within 4.5 h after symptom onset.,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, PR China. Electronic address: chaojzzu@126.com.'}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The Johns Hopkins University, Baltimore, MD 21218, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, PR China; Department of Anatomy, College of Basic Medical Science, Zhengzhou University, Zhengzhou, Henan, PR China.'}, {'ForeName': 'Jiewen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, People's Hospital of Zhengzhou University, Zhengzhou, PR China. Electronic address: zhangjiewen9900@126.com.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105136']
2716,32903814,Effects of Erythropoietin-Stimulating Agents on Blood Pressure in Patients with Non-Dialysis CKD and Renal Anemia.,"Introduction


Erythropoietin-stimulating agents (ESAs) are used to treat renal anemia in patients with non-dialysis CKD, but this can lead to increases in blood pressure (BP).
Objective


We investigated the effects of continuous erythropoietin receptor activator (CERA) and darbepoetin alfa (DA) on office/ambulatory BP in 36 patients with non-dialysis CKD and renal anemia who did not receive ESA treatment.
Methods


Participants were randomly assigned to CERA or DA, and received ESA treatment for 24 weeks. ESA doses were adjusted to maintain hemoglobin (Hb) at 10-12 g/dL. Primary outcomes were office/ambulatory BP after 24 weeks of ESA treatment. Hb levels were within the target range at 24 weeks.
Results


Office/ambulatory BP, renal function, and other parameters were not significantly different between groups. However, we could not exclude the possibility that differences may exist because our sample size was small. Therefore, we also performed analysis of all of the data that were compiled from the groups of per-protocol population. Although office/ambulatory BP profiles had not worsened after 24 weeks of ESA treatment, more than half of the patients required an increase in the antihypertensive agent dose.
Conclusions


CERA and DA may have similar effects on BP profiles in patients with non-dialysis CKD and renal anemia. ESA treatment often requires increases in the doses of antihypertensive agents.",2020,"Results


Office/ambulatory BP, renal function, and other parameters were not significantly different between groups.","['patients with non-dialysis CKD', 'Patients with Non-Dialysis CKD and Renal Anemia', '36 patients with non-dialysis CKD and renal anemia who did not receive ESA treatment', 'patients with non-dialysis CKD and renal anemia']","['Erythropoietin-Stimulating Agents', 'ESA', 'CERA or DA, and received ESA', 'continuous erythropoietin receptor activator (CERA) and darbepoetin alfa (DA', 'Erythropoietin-stimulating agents (ESAs']","['BP profiles', 'Hb levels', 'blood pressure (BP', 'Blood Pressure', 'Results\n\n\nOffice/ambulatory BP, renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1142276', 'cui_str': 'Renal anemia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1701991', 'cui_str': 'Continuous erythropoietin receptor activator'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",36.0,0.0262071,"Results


Office/ambulatory BP, renal function, and other parameters were not significantly different between groups.","[{'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Ohki', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Wakui', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Uneda', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Azushima', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Haruhara', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kinguchi', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Urate', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamaji', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Kanaoka', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Minegishi', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Ishigami', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Fujikawa', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Toya', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kouichi', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}]","Kidney diseases (Basel, Switzerland)",['10.1159/000507396']
2717,32903953,The Efficacy and Safety of Low Dose versus Usual Dose of Hyoscine During Endoscopic Retrograde Cholangiopancreatography: A Randomized Clinical Trial.,"Purpose


To evaluate the efficacy and safety of low dose versus usual dose of Hyoscine during endoscopic retrograde cholangiopancreatography (ERCP).
Patients and Methods


This randomized, open-label clinical trial included 282 patients undergoing ERCP who had duodenal peristalsis interfering with cannulation. Patients were randomly divided into two groups: Group one and two received low (5 mg) and usual (10 mg) dose of Hyoscine, respectively. Cardiovascular service consultation was performed for all patients before entering the study and performing ERCP. Hyoscine was injected intravenously, and the spasmolytic effect of the drug was assessed while the papilla was in a completely enface view. The time interval between cessation of peristalsis and its further onset was recorded by the chronometer. Also, patient's heart rate and blood pressure were monitored during ERCP by digital monitoring.
Results


The results showed no statistically significant differences in the mean duration of peristalsis, the duration of the antispasmodic activity and the time required to increase the heart rate between two groups (P=0.38, P=0.48, P=0.32, respectively). No significant differences were observed regarding the average of heart rate and mean arterial blood pressure (MAP) before drug administration between the two groups (P=0.182 and P=0.29, respectively), but after the drug administration, tachycardia and hypotension were significantly higher in the second group (P=0.007 and P=0.001, respectively). There was no statistically significant difference in the frequency of arrhythmia between two groups (P=0.08). The results also showed that tachycardia and hypotension occurred more frequently in men and elderly patients (P <0.05).
Conclusion


A low dose of Hyoscine is as effective as the usual dose and its side effects such as alteration in blood pressure and heart rate are much fewer, especially in men and elderly patients.",2020,"The results also showed that tachycardia and hypotension occurred more frequently in men and elderly patients (P <0.05).
","['282 patients undergoing ERCP who had duodenal peristalsis interfering with cannulation', 'men and elderly patients']","['endoscopic retrograde cholangiopancreatography (ERCP', 'Hyoscine', 'Endoscopic Retrograde Cholangiopancreatography']","['heart rate and blood pressure', 'blood pressure and heart rate', 'tachycardia and hypotension', 'efficacy and safety', 'Cardiovascular service consultation', 'time interval between cessation of peristalsis and its further onset', 'mean duration of peristalsis, the duration of the antispasmodic activity', 'heart rate', 'frequency of arrhythmia', 'average of heart rate and mean arterial blood pressure (MAP']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0031133', 'cui_str': 'Peristalsis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037766', 'cui_str': 'Antispasmodic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",282.0,0.0284825,"The results also showed that tachycardia and hypotension occurred more frequently in men and elderly patients (P <0.05).
","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Salmanroghani', 'Affiliation': 'Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Massoud', 'Initials': 'M', 'LastName': 'Mirvakili', 'Affiliation': 'Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahtabalsadat', 'Initials': 'M', 'LastName': 'Mirjalili', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahmud', 'Initials': 'M', 'LastName': 'Baghbanian', 'Affiliation': 'Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Roham', 'Initials': 'R', 'LastName': 'Salmanroghani', 'Affiliation': 'Medical Student Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Clinical pharmacology : advances and applications,['10.2147/CPAA.S263531']
2718,32904004,"A randomized comparative trial of corticosteroid phonophoresis, local corticosteroid injection, and low-level laser in the treatment of carpal tunnel syndrome.","Background and aims


Carpal tunnel syndrome is the most prevalent peripheral neuropathy and has a considerable burden on health services. We tried to compare the therapeutic effects of local corticosteroid injection, low-level laser, and corticosteroid phonophoresis in the treatment of carpal tunnel syndrome.
Subjects and methods


We performed a randomized clinical trial with three parallel groups. The study was carried out at a University Hospital. In total, 42 participants including 31(73.8%) women were randomly allocated to the treatment groups with equal sizes. We assessed pain, symptom severity and functional status with Boston Carpal Tunnel Questionnaire, and performed median nerve conduction velocity studies. Evaluations were done before the interventions and in the fourth week of study. For the group corticosteroid, under the guidance of sonography, methylprednisolone with lidocaine was injected into the carpal tunnel. For laser therapy, we administered 10 sessions, each lasting 10 seconds. We used topical hydrocortisone acetate gel 10% as the anti-inflammatory agent with phonophoresis, 3 times per week for 10 sessions.
Results


Within-group analyses with paired t-test showed that local corticosteroid, laser, and phonophoresis are all effective treatments. Between-group analyses with ANOVA indicated that there were significant differences among the groups after four weeks in terms of pain (p = 0.004), in favor of corticosteroid; and in sensory delay (p = 0.001), in favor of laser. For the Boston Carpal Tunnel Questionnaire and median nerve motor latency, the results were not significant. There was no important side-effect after four weeks of follow-up.
Conclusion


The three treatments are comparable and beneficial for carpal tunnel syndrome.",2020,"For the Boston Carpal Tunnel Questionnaire and median nerve motor latency, the results were not significant.","['carpal tunnel syndrome', '42 participants including 31(73.8%) women']","['corticosteroid phonophoresis, local corticosteroid injection, and low-level laser', 'topical hydrocortisone acetate gel', 'sonography, methylprednisolone with lidocaine', 'local corticosteroid injection, low-level laser, and corticosteroid phonophoresis']","['pain, symptom severity and functional status with Boston Carpal Tunnel Questionnaire, and performed median nerve conduction velocity studies', 'Boston Carpal Tunnel Questionnaire and median nerve motor latency', 'sensory delay', 'pain']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0031582', 'cui_str': 'Phonophoresis therapy'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C3218301', 'cui_str': 'Hydrocortisone-containing product in cutaneous dose form'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025058', 'cui_str': 'Structure of median nerve'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]",42.0,0.0227504,"For the Boston Carpal Tunnel Questionnaire and median nerve motor latency, the results were not significant.","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Asheghan', 'Affiliation': 'Baqiyatallah University of Medical Sciences, School of Medicine, Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Amidoddin Khatibi', 'Initials': 'AK', 'LastName': 'Aghda', 'Affiliation': 'Shahid Sadoughi University of Medical Sciences, School of Medicine, Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sobhani', 'Affiliation': 'Baqiyatallah University of Medical Sciences, School of Medicine, Institute of life style, exercise physiology research center.'}, {'ForeName': 'Seyed Ebrahim', 'Initials': 'SE', 'LastName': 'Hashemi', 'Affiliation': 'Baqiyatallah University of Medical Sciences, School of Medicine, Department of Physical Medicine and Rehabilitation.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Hollisaz', 'Affiliation': 'Baqiyatallah University of Medical Sciences, School of Medicine, Department of Physical Medicine and Rehabilitation.'}]",Laser therapy,['10.5978/islsm.20-OR-01']
2719,32904022,"Clinical and Radiographic Evaluation of Pulpotomy using MTA, Biodentine and Er,Cr:YSGG Laser in primary teeth- A Clinical Study.","Background


The aim of the study was to compare the clinical and radiographic evaluation of pulpotomy using mineral trioxide aggregate (MTA), calcium silicate-based cement (Biodentine), and Er,Cr:YSGG laser in primary molars.
Materials and methods


Fifty-four primary teeth were selected for this study as per the inclusion and exclusion criteria in the age group of 4-9 years and then randomly allocated to three groups A, B & C. In group A, after removal of coronal pulp, MTA was placed at the floor of pulp chamber. In group B, calcium silicate-based cement (Biodentine) was placed at the floor of pulp chamber. In group C, decontamination of the cavity was done with Er,Cr:YSGG laser. This was followed by placement of permanent restorative material in all the groups. Clinical and radiographic success was evaluated at 3, 6 and 9 months. Data analysis was performed using Statistical Package for the Social Science-21 (SPSS-21).
Results


At the end of 9 months, overall success rate of pulpotomy was 85.5%. There was no significant difference among the three groups (p > 0.05).
Conclusion


The study showed that the success of pulpotomy procedure is independent of the type of medicament used for pulpotomy. Moreover, the study also shows that Er,Cr:YSGG laser can be effectively used for pulpotomy procedures.",2020,"There was no significant difference among the three groups (p > 0.05).
","['Materials and methods\n\n\nFifty-four primary teeth were selected for this study as per the inclusion and exclusion criteria in the age group of 4-9 years', 'primary molars']","['Cr', 'pulpotomy using mineral trioxide aggregate (MTA), calcium silicate-based cement (Biodentine), and Er,Cr:YSGG laser', 'MTA, Biodentine and Er', 'YSGG Laser', 'calcium silicate-based cement (Biodentine']","['Clinical and radiographic success', 'overall success rate of pulpotomy']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0054483', 'cui_str': 'calcium silicate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}]",54.0,0.0248205,"There was no significant difference among the three groups (p > 0.05).
","[{'ForeName': 'Pandiyan', 'Initials': 'P', 'LastName': 'Ramanandvignesh', 'Affiliation': 'Pedodontics & Preventive Dentistry Maulana Azad Institute of Dental Sciences New Delhi.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Gyanendra', 'Affiliation': 'Pedodontics & Preventive Dentistry Maulana Azad Institute of Dental Sciences New Delhi.'}, {'ForeName': 'Dhillon', 'Initials': 'D', 'LastName': 'Jatinder Kaur Goswami Mridula', 'Affiliation': 'Pedodontics & Preventive Dentistry Maulana Azad Institute of Dental Sciences New Delhi.'}]",Laser therapy,['10.5978/islsm.20-OR-03']
2720,32904122,Comparative Evaluation of Microleakage in Various Placement Techniques of Composite Restoration: An  In Vitro  Study.,"Aim


The study was conducted to evaluate and compare the effect of various placement techniques of composite restoration on microleakage.
Materials and methods


Forty extracted premolars were selected and a rectangular-shaped cavity was prepared on the buccal surface of cervical third of each tooth. Thereafter, teeth were randomly divided into four groups equally and were restored with the composite restorative material with different placement techniques, i.e., bulk placement technique, horizontal incremental technique, split incremental technique, and newly introduced Mat incremental technique. Samples were thermocycled and immersed in methylene blue dye for 24 hours. The samples were then sectioned and evaluated under a stereomicroscope for microleakage.
Results


Microleakage was present least in the Mat incremental group and maximum in the bulk placement group while intercomparison revealed statistically significant difference between all the groups except for split incremental and Mat incremental groups.
Conclusion


The recently introduced Mat incremental placement technique showed least microleakage when compared to conventional techniques.
How to cite this article


Somani R, Som NK, Jaidka S,  et al.  Comparative Evaluation of Microleakage in Various Placement Techniques of Composite Restoration: An  In Vitro  Study. Int J Clin Pediatr Dent 2020;13(3):264-268.",2020,"Results


Microleakage was present least in the Mat incremental group and maximum in the bulk placement group while intercomparison revealed statistically significant difference between all the groups except for split incremental and Mat incremental groups.
",['Composite Restoration'],"['composite restorative material with different placement techniques, i.e., bulk placement technique, horizontal incremental technique, split incremental technique, and newly introduced Mat incremental technique', 'Microleakage']",[],"[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}]",[],40.0,0.0185643,"Results


Microleakage was present least in the Mat incremental group and maximum in the bulk placement group while intercomparison revealed statistically significant difference between all the groups except for split incremental and Mat incremental groups.
","[{'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Somani', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Nitin K', 'Initials': 'NK', 'LastName': 'Som', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Shipra', 'Initials': 'S', 'LastName': 'Jaidka', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Ghaziabad, Uttar Pradesh, India.'}, {'ForeName': 'Sharib', 'Initials': 'S', 'LastName': 'Hussain', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, DJ College of Dental Sciences and Research, Modinagar, Ghaziabad, Uttar Pradesh, India.'}]",International journal of clinical pediatric dentistry,['10.5005/jp-journals-10005-1764']
2721,32904126,"Efficacy of betamethasone, hyaluronidase and its combination on mouth opening, burning sensation and QOL in patients with OSF.","Objectives


To assess the efficacy of betamethasone, hyaluronidase and its combination on mouth opening, burning sensation and quality of life (QOL) in patients with oral submucous fibrosis.
Study design


Sixty patients were divided in 4 groups; group A received 8 mg of betamethasone, group B received 3000 IU of hyaluronidase, group C received the combination of betamethasone and hyaluronidase and group D received saline injections biweekly for 5 weeks. Patients were also assessed using QOL questionnaire.
Results


Mouth opening and oral burning of the four groups for final visit, using the pretreatment opening as a covariate showed significant difference for group A, B, C.
Conclusion


Betamethasone and hyaluronidase injections appears to be a viable option to increase mouth opening with reduction in burning sensation.",2020,"Results


Mouth opening and oral burning of the four groups for final visit, using the pretreatment opening as a covariate showed significant difference for group A, B, C.
Conclusion


","['patients with OSF', 'Sixty patients', 'patients with oral submucous fibrosis']","['betamethasone and hyaluronidase and group D received saline injections', 'betamethasone, hyaluronidase and its combination', 'betamethasone', 'Betamethasone and hyaluronidase injections']","['Results\n\n\nMouth opening and oral burning', 'QOL questionnaire', 'mouth opening, burning sensation and quality of life (QOL', 'mouth opening, burning sensation and QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029172', 'cui_str': 'Oral submucosal fibrosis'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0020197', 'cui_str': 'Hyaluronidase'}, {'cui': 'C0441838', 'cui_str': 'Group D'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4283365', 'cui_str': 'Hyaluronidase Injection'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}]",60.0,0.0522332,"Results


Mouth opening and oral burning of the four groups for final visit, using the pretreatment opening as a covariate showed significant difference for group A, B, C.
Conclusion


","[{'ForeName': 'Mohd', 'Initials': 'M', 'LastName': 'Saalim', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, Maharashtra India.'}, {'ForeName': 'Kaustubh', 'Initials': 'K', 'LastName': 'Sansare', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, Maharashtra India.'}, {'ForeName': 'Ibrahim K', 'Initials': 'IK', 'LastName': 'Ali', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, Maharashtra India.'}, {'ForeName': 'Heena', 'Initials': 'H', 'LastName': 'Sonawane', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, India.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vanga', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, Maharashtra India.'}, {'ForeName': 'Ruchika', 'Initials': 'R', 'LastName': 'Kapoor', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, India.'}, {'ForeName': 'Freny R', 'Initials': 'FR', 'LastName': 'Karjodkar', 'Affiliation': 'Department of Oral Medicine and Radiology, Nair Hospital Dental College, Mumbai, Maharashtra India.'}]",Journal of oral biology and craniofacial research,['10.1016/j.jobcr.2020.07.007']
2722,32904133,Acupuncture for dry eye syndrome after refractive surgery: A randomized controlled pilot trial.,"Background


Dry eye syndrome is the most common complication of refractive surgery. Acupuncture is widely used for the treatment of ophthalmologic diseases, but to date, few have explored the effects of acupuncture for the treatment of this condition following refractive surgery. The objective of this study is to assess the feasibility of a study design for evaluating the effectiveness of acupuncture treatment along with usual care compared with usual care only for dry eye syndrome after refractive surgery.
Methods


A total of 18 patients with dry eye syndrome occurring after refractive surgery participated in this study. For 4 weeks, the acupuncture plus usual care and usual care only groups received treatment three times a week. A series of assessments, namely the ocular surface disease index (OSDI), visual analog scale for ocular discomfort, quality of life, tear film break-up time, Schirmer 1 test, and fluorescein-stained corneal-surface photography, along with other general assessments were carried out.
Results


Although preliminary, changes in OSDI from the baseline values were significantly different between the two groups at week 5 ( p  = 0.0003). There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups ( p  = 0.0039). No serious adverse events were reported during the study.
Conclusion


Four weeks of acupuncture treatment in addition to usual care is a feasible treatment for dry eye syndrome after refractive surgery. A full-scale randomized controlled trial is needed to confirm the clinical effectiveness of acupuncture.",2021,There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups ( p  = 0.0039).,"['18 patients with dry eye syndrome occurring after refractive surgery participated in this study', 'dry eye syndrome after refractive surgery']","['Acupuncture', 'acupuncture']","['OSDI', 'OSDI changes', 'ocular surface disease index (OSDI), visual analog scale for ocular discomfort, quality of life, tear film break-up time, Schirmer 1 test, and fluorescein-stained corneal-surface photography', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C1274010', 'cui_str': 'Refractive surgery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",18.0,0.0802618,There was a significant difference in the trends of OSDI changes between the acupuncture plus usual care and the usual care only groups ( p  = 0.0039).,"[{'ForeName': 'Jun-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Kyungsun', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Tae-Hun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Ae-Ran', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Ojin', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Joo-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Jeong-Eun', 'Initials': 'JE', 'LastName': 'Kim', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Seunghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Mi-Suk', 'Initials': 'MS', 'LastName': 'Shin', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'So-Young', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Hyo-Ju', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Clinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}, {'ForeName': 'Sanghun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Future Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.'}]",Integrative medicine research,['10.1016/j.imr.2020.100456']
2723,32912410,[Study of multimodal monitoring in neurocritical care patients].,"OBJECTIVE


To explore the significance of multimodal monitoring in the monitoring and treatment of neurocritical care patients.
METHODS


104 neurocritical care patients admitted to the department of Critical Care Medicine of Fujian Provincial Hospital from March 2019 to January 2020 were enrolled. Patients were randomly assigned into two groups, with 52 in each group. In the routine monitoring treatment group, heart rate, blood pressure, respiratory rate and the changes in consciousness and pupils were monitored after operation. The patients were treated with routine medicine to reduce intracranial pressure (ICP), maintain proper cerebral perfusion pressure (CPP), balance fluid intake and output, and maintain the airway clear. Patients in the multimodal monitoring treatment group were treated with invasive ICP monitoring, ultrasound to assess brain structure, ultrasound to measure optic nerve sheath diameter (ONSD), transcranial color doppler (TCCD), internal jugular venous blood oxygen saturation monitoring, near-infrared spectroscopy (NIRS), non-invasive cerebral blood oxygen saturation monitoring and quantitative electroencephalogram monitoring. According to the monitoring results, the patients were given targeted treatment with the goal of controlling ICP and improving brain metabolism. The length of intensive care unit (ICU) stay, the incidences of neurological complications (secondary cerebral infarction, cerebral hemorrhage, high intracranial pressure, etc.), and the incidences of poor prognosis [6 months after the onset of Glasgow outcome score (GOS) 1 to 3] were compared between the two groups. Spearman rank correlation analysis of the correlation between invasive ICP and the ICP value which was calculated by TCCD. The receiver operating characteristic (ROC) curve of invasive ICP and pulsatility index of middle cerebral artery (PI MCA ) were used to predict poor prognosis.
RESULTS


The length of ICU stay in the multimodal monitoring treatment group was significantly shorter than that of the routine monitoring treatment group (days: 6.27±3.81 vs. 9.61±5.09, P < 0.01), and the incidence of neurological complications was significantly lower than that in the routine monitoring treatment group (9.62% vs. 25.00%, P < 0.05). In the multimodal monitoring treatment group, 37 cases had a good prognosis and 15 cases had a poor prognosis, while the routine monitoring treatment group had a good prognosis in 27 cases and a poor prognosis in 25 cases. The incidence of poor prognosis in the multimodal monitoring treatment group was lower than that of the routine monitoring treatment group (28.85% vs. 48.08%, P < 0.05). In the multimodal monitoring treatment group, the invasive ICP and PI MCA  of patients with good prognosis were significantly lower than those of patients with poor prognosis [invasive ICP (mmHg, 1 mmHg = 0.133 kPa): 16 (12, 17) vs. 22 (20, 24), PI MCA : 0.90±0.33 vs. 1.39±0.58, both P < 0.01]. There was no significant difference in resistance index of the middle cerebral artery (RI MCA ) between the good prognosis group and the poor prognosis group (0.63±0.12 vs. 0.66±0.15, P > 0.05). There was a positive correlation between the invasive ICP and the ICP value which was calculated by TCCD (r = 0.767, P < 0.001). ROC curve analysis showed that the area under ROC curve (AUC) of invasive ICP for poor prognosis prediction was 0.906, the best cut-off value was ≥ 18 mmHg, the sensitivity was 86.49%, and the specificity was 86.67%. The AUC of PIMCA for poor prognosis prediction was 0.759, the best cut-off value was ≥ 1.12, the sensitivity was 81.08%, and the specificity was 60.00%. The AUC of invasive ICP was greater than PI MCA  (Z = 2.279, P = 0.023).
CONCLUSIONS


Comprehensive analysis of multimodal monitoring indicators for neurocritical care patients to guide clinical treatment can reduce the length of hospital stay, and reduce the risk of neurosurgery complications and disability; invasive ICP can predict poor prognosis of neurocritical care patients.",2020,"The AUC of invasive ICP was greater than PI MCA  (Z = 2.279, P = 0.023).
","['neurocritical care patients', '104 neurocritical care patients admitted to the department of Critical Care Medicine of Fujian Provincial Hospital from March 2019 to January 2020 were enrolled']","['invasive ICP monitoring, ultrasound to assess brain structure, ultrasound to measure optic nerve sheath diameter (ONSD), transcranial color doppler (TCCD), internal jugular venous blood oxygen saturation monitoring, near-infrared spectroscopy (NIRS), non-invasive cerebral blood oxygen saturation monitoring and quantitative electroencephalogram monitoring', 'routine medicine']","['incidence of neurological complications', 'resistance index of the middle cerebral artery (RI MCA ', 'AUC of invasive ICP', 'length of hospital stay', 'length of ICU stay', 'brain metabolism', 'receiver operating characteristic (ROC) curve of invasive ICP and pulsatility index of middle cerebral artery (PI MCA ', 'invasive ICP and PI MCA  of patients with good prognosis', 'incidence of poor prognosis', 'intracranial pressure (ICP), maintain proper cerebral perfusion pressure (CPP), balance fluid intake and output, and maintain the airway clear', 'length of intensive care unit (ICU) stay, the incidences of neurological complications (secondary cerebral infarction, cerebral hemorrhage, high intracranial pressure, etc.), and the incidences of poor prognosis', 'heart rate, blood pressure, respiratory rate and the changes in consciousness and pupils']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1319411', 'cui_str': 'Critical care medicine'}, {'cui': 'C3661820', 'cui_str': 'Provincial hospital'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0150260', 'cui_str': 'Intracranial pressure monitoring regime'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0428174', 'cui_str': 'Hemoglobin saturation with oxygen'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0000325', 'cui_str': '20-Methylcholanthrene'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0428713', 'cui_str': 'Cerebral perfusion pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]",,0.0172345,"The AUC of invasive ICP was greater than PI MCA  (Z = 2.279, P = 0.023).
","[{'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou 350001, Fujian, China. Corresponding author: Chen Han, Email: baojr2@163.com.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Rongguo', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Jingqing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Yingrui', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Wanli', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200130-00148']
2724,32912514,"Adherence to study drug in a stroke prevention trial""?>.","OBJECTIVE


Standards for reporting and analyzing adherence to medical therapy have recently improved due to international consensus efforts. If applied to clinical trial research in patients with stroke, these improvements have the potential to identify when in the sequence of trial operations participants are at risk for non-adherence and opportunities to safeguard adherence.
METHODS


We analyzed three phases of adherence according to the European Society for Patient Adherence, COMpliance, and Persistence (ESPACOMP) Medication Adherence Reporting Guideline (EMERGE) taxonomy in the Insulin Resistance Intervention after Stroke (IRIS) trial: initiation (did patient start drug), implementation (did patient take a drug holiday, defined as temporary cessation lasting ≥14 days), and persistence (did patient prematurely and permanently discontinue drug). IRIS was a randomized, placebo controlled, double-blind trial testing pioglitazone to prevent stroke or myocardial infarction in patients with a recent ischemic stroke or transient ischemic attack. Adherence was classified by self-report. Researchers used coaching algorithms to seek adherence recovery if participants went off drug.
RESULTS


During 2005-2013, 3876 participants were enrolled from 179 sites in seven countries and followed for a mean of 4.8 years. Less than 1% of participants in each group did not initiate study drug. 20% of patients assigned to pioglitazone and 17% assigned to placebo took at least one drug holiday. 36% and 30%, respectively, discontinued the study drug prematurely with or without a prior holiday. The risk for stopping the study drug (temporarily or permanently) in the first year after randomization was twice the risk in each of the subsequent four years. This was true both for patients assigned to active therapy and placebo. More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one. In years two through five, rates of discontinuation were similar in the two treatment groups. The difference in rates during year one was the result of adverse effects related to the active study drug, pioglitazone. During the remainder of the trial, the attribution of discontinuations to adverse effects potentially related to pioglitazone was reduced but still higher in those assigned to active drug. Other reasons for discontinuation were similar between treatment groups and were largely unrelated to pharmacodynamic effects of the study drug. Rates of discontinuation varied widely among research sites.
CONCLUSION


Patients in a drug trial for stroke prevention are at greatest risk for premature drug discontinuation early after randomization. Reasons for discontinuation change over time. Variable discontinuation rates among sites suggests that adherence can be improved by using best practices from high-performing sites.",2020,"More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one.","['participants went off drug', 'During 2005-2013, 3876 participants were enrolled from 179 sites in seven countries and followed for a mean of 4.8 years', 'patients with a recent ischemic stroke or transient ischemic attack', 'patients with stroke']","['placebo', 'pioglitazone']","['stroke or myocardial infarction', 'rates of discontinuation']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",3876.0,0.437434,"More participants assigned to pioglitazone, compared to placebo, took a drug holiday or permanently stopped study drug, but the difference in rates of discontinuation was only evident in year one.","[{'ForeName': 'Akshatha', 'Initials': 'A', 'LastName': 'Kiran', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: Akshatha.kiran@yale.edu.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Viscoli', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: catherine.viscoli@yale.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Furie', 'Affiliation': 'Alpert Medical School of Brown University, Providence, RI, United States. Electronic address: kfurie@lifespan.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gorman', 'Affiliation': 'Maine Medical Center, Portland, ME, United States.'}, {'ForeName': 'Walter N', 'Initials': 'WN', 'LastName': 'Kernan', 'Affiliation': 'Yale School of Medicine, New Haven, CT, United States. Electronic address: walter.kernan@yale.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105048']
2725,32912546,Seizure Prophylaxis in Unruptured Aneurysm Repair: A Randomized Controlled Trial.,"BACKGROUND


Prophylactic antiepileptic drugs (pAEDs) are often prescribed for seizure prophylaxis in patients undergoing surgical treatment of unruptured intracranial aneurysms (UIAs). We aimed to evaluate the benefit of pAEDs in patients undergoing surgical repair of UIAs.
METHODS


We randomly assigned eligible patients undergoing surgical repair of UIAs to receive levetiracetam for seven days post-operatively or standard care alone. The primary outcome was the evaluation of seizures in the perioperative period (within 4 weeks). We also evaluated seizure occurrence throughout follow-up and assessed functional outcomes using the modified Rankin scale score (mRS).
RESULTS


35 patients were randomized to the ""no-levetiracetam"" group and 41 patients were randomized to receive levetiracetam. The two study groups had similar overall baseline characteristics and the surgical complication rate was similar for both groups (p = 0.8). One patient in the ""no-levetiracetam"" group had a seizure in the perioperative period versus 2 patients in the group randomized to receive levetiracetam (2.9% vs 4.9%, respectively, p = 1.00). No patients in the ""no-levetiracetam"" group had any additional late seizures (mean follow-up of 20.4 months), but three patients in the levetiracetam group had late seizures during follow-up (mean follow-up of 19.1 months) (0% vs 7.3%, p = 0.2). mRS score of 0-2 at 90 days and at the latest follow-up were similar between the two groups (p = 1.00).
CONCLUSIONS


Perioperative seizure prophylaxis with levetiracetam does not reduce the rate of seizures as compared to controls in patients undergoing surgical repair of UIAs.",2020,"No patients in the ""no-levetiracetam"" group had any additional late seizures (mean follow-up of 20.4 months), but three patients in the levetiracetam group had late seizures during follow-up (mean follow-up of 19.1 months)","['35 patients', 'patients undergoing surgical treatment of unruptured intracranial aneurysms (UIAs', 'Unruptured Aneurysm Repair', 'group and 41 patients', 'patients undergoing surgical repair of UIAs']","['Prophylactic antiepileptic drugs (pAEDs', 'surgical repair of UIAs to receive levetiracetam for seven days post-operatively or standard care alone', 'no-levetiracetam', 'mRS', 'pAEDs', 'levetiracetam']","['modified Rankin scale score (mRS', 'late seizures', 'evaluation of seizures', 'surgical complication rate', 'additional late seizures', 'rate of seizures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",35.0,0.190527,"No patients in the ""no-levetiracetam"" group had any additional late seizures (mean follow-up of 20.4 months), but three patients in the levetiracetam group had late seizures during follow-up (mean follow-up of 19.1 months)","[{'ForeName': 'Badih J', 'Initials': 'BJ', 'LastName': 'Daou', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: bdaou@med.umich.edu.'}, {'ForeName': 'Cormac O', 'Initials': 'CO', 'LastName': 'Maher', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: adityap@med.umich.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Holste', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: holsteka@med.umich.edu.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Palmateer', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: gpalmate@umich.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Lint', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: clsimpso@med.umich.edu.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Elenbaas', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: jmacaula@med.umich.edu.'}, {'ForeName': 'B Gregory', 'Initials': 'BG', 'LastName': 'Thompson', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: cmaher@med.umich.edu.'}, {'ForeName': 'Aditya S', 'Initials': 'AS', 'LastName': 'Pandey', 'Affiliation': 'Department of Neurosurgery, University of Michigan, 1500 E. Medical Center Drive, 3552 Taubman Center Ann Arbor 48109-5338, Michigan. Electronic address: adityap@med.umich.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105171']
2726,32912556,Therapeutic Effects of Diagonal-Transcranial Direct Current Stimulation on Functional Recovery in Acute Stroke: A Pilot Study.,"BACKGROUND


Peak neurologic recovery from acute stroke occurs within the first 3 months, and continues at a slower pace for 6 months.
OBJECTIVE/HYPOTHESIS


The aim of this pilot study is to clarify the safety and feasibility of multiple diagonal-transcranial direct current stimulation (d-tDCS) sessions up to 3 months with electrodes placed diagonally over the lesional dorsolateral prefrontal cortex and contralesional primary motor cortex for upper limb hemiparesis in acute stroke.
METHODS


Five patients with acute stroke (2 with intracerebral hemorrhage and 3 with cerebral infarction) with upper limb paresis participated. d-tDCS (1 mA, 20 min per day) combined with conventional rehabilitation was given starting 7-21 days after stroke onset. Each session consisted of 10 d-tDCS over 2 weeks and patients received 2 sessions in the acute phase and 2 sessions in the subacute phase for a total 40 treatments. Motor function was assessed using Fugl-Meyer Assessment for upper extremity (FMA-UE) before and after each session, and the period to achieve 70% of maximal potential recovery in FMA-UE was evaluated.
RESULTS


All 5 patients completed the intervention and showed no adverse effects throughout the protocol. Of these, 3 (60%) achieved 70% predicted scores within 2 months. Regarding therapeutic gains of FMA-UE in each of the 10 sessions in the acute phase, 4 sessions showed great recovery, 3 sessions showed moderate recovery, and 3 sessions showed poor recovery.
CONCLUSION


These findings suggest that d-tDCS over 3 months may be safe and feasible for acute stroke patients in the acute to subacute phases and have therapeutic potential to promote recovery of upper limb function, although further randomized, double-blind, sham-controlled trial is warranted with larger sample size.",2020,"Motor function was assessed using Fugl-Meyer Assessment for upper extremity (FMA-UE) before and after each session, and the period to achieve 70% of maximal potential recovery in FMA-UE was evaluated.
","['Acute Stroke', 'acute stroke patients', 'Five patients with acute stroke (2 with intracerebral hemorrhage and 3 with cerebral infarction) with upper limb paresis participated']","['multiple diagonal-transcranial direct current stimulation (d-tDCS) sessions', 'Diagonal-Transcranial Direct Current Stimulation', 'conventional rehabilitation']","['adverse effects', 'Motor function']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0443198', 'cui_str': 'Diagonal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",5.0,0.119736,"Motor function was assessed using Fugl-Meyer Assessment for upper extremity (FMA-UE) before and after each session, and the period to achieve 70% of maximal potential recovery in FMA-UE was evaluated.
","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'Department of Neurosurgery, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan. Electronic address: sibata@med.u-toyama.ac.jp.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Urata', 'Affiliation': 'Department of Rehabilitation, Toyama Prefectural Rehabilitation Hospital and Support Center for Children with Disabilities, Toyama, Japan. Electronic address: urata@toyama-reha.or.jp.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Kawahara', 'Affiliation': 'Department of Rehabilitation, Toyama Prefectural Rehabilitation Hospital and Support Center for Children with Disabilities, Toyama, Japan. Electronic address: ot3@toyama-reha.or.jp.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Furuya', 'Affiliation': 'Department of Rehabilitation, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ishikuro', 'Affiliation': 'Department of Rehabilitation, University of Toyama, Toyama, Japan. Electronic address: ishikuro@med.u-toyama.ac.jp.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Department of Rehabilitation, University of Toyama, Toyama, Japan. Electronic address: hattorin@med.u-toyama.ac.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kuroda', 'Affiliation': 'Department of Neurosurgery, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan. Electronic address: skuroda@med.u-toyama.ac.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105107']
2727,32912592,Sleep in pituitary insufficient patients compared to patients with depression and healthy controls at baseline and after challenge with CRH.,"Sleep disturbances are prevalent in both patients with pituitary insufficiency and with depression. The role of corticotropin releasing hormone (CRH), involved in sleep regulation, has not been fully clarified. Pituitary insufficiency is an ideal model for studying sleep-endocrine effects since no consecutive hormone releases and feedback effects occur after hormone administration. 11 male patients with a chronic insufficiency of the anterior pituitary gland (PI) and under stable hormonal substitution were studied during three consecutive nights in the sleep laboratory. The first night served for adapting to laboratory setting, during the second night placebo was administered and during the third night 4 × 50 μg CRH were injected in pulsatile fashion. Sleep parameters were additionally compared with those of 15 healthy male controls (C) and 15 male patients with depression (D). CRH administration was associated with a numerical increase of wake time (115 ± 15 to 131 ± 13 min) and a decrease of REM sleep (89 ± 8 to 80 ± 8 min), REM latency (69 ± 14 to 55 ± 9 min) and slow wave sleep (66 ± 16 to 57 ± 15 min). Yet, none of these changes reached statistical significance. PI showed a worse sleep profile as compared to both control groups, e.g. indicated by a significantly lower sleep efficiency index (PI:0.80 ± 0.03 vs. C:0.94 ± 0.01 vs. D:0.87 ± 0.03). In conclusion sleep-EEG changes after CRH in PI patients resemble those found in in part in patients with depression. Sleep in anterior pituitary insufficiency was impaired despite full hormonal substitution possibly suggesting an alteration of the receptor organisation of brain structures involved in sleep regulation.",2020,"PI showed a worse sleep profile as compared to both control groups, e.g. indicated by a significantly lower sleep efficiency index (PI:0.80 ± 0.03 vs. C:0.94 ± 0.01 vs. D:0.87 ± 0.03).","['patients with pituitary insufficiency and with depression', '15 healthy male controls (C) and 15 male patients with depression (D', '11 male patients with a chronic insufficiency of the anterior pituitary gland (PI) and under stable hormonal substitution were studied during three consecutive nights in the sleep laboratory']","['CRH', 'placebo', 'corticotropin releasing hormone (CRH']","['Sleep', 'sleep efficiency index', 'Sleep parameters', 'wake time (115\xa0±', 'Sleep disturbances', 'REM sleep', 'worse sleep profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020635', 'cui_str': 'Hypopituitarism'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231183', 'cui_str': 'Chronic insufficiency'}, {'cui': 'C0032008', 'cui_str': 'Adenohypophysis structure'}, {'cui': 'C0032005', 'cui_str': 'Pituitary structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",11.0,0.0125542,"PI showed a worse sleep profile as compared to both control groups, e.g. indicated by a significantly lower sleep efficiency index (PI:0.80 ± 0.03 vs. C:0.94 ± 0.01 vs. D:0.87 ± 0.03).","[{'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Künzel', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany; Ludwig-Maximilians-University, Department of Internal Medicine, Psychosomatic Out-Patient-Clinic, Munich, Germany. Electronic address: Heike.Kuenzel@med.uni-muenchen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kluge', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany; Universität Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Zeising', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany; Klinikum Ingolstadt, Zentrum für Psychische Gesundheit, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Schopohl', 'Affiliation': 'Ludwig-Maximilians-University, Department of Internal Medicine, Psychosomatic Out-Patient-Clinic, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Yassouridis', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'Günther-Karl', 'Initials': 'GK', 'LastName': 'Stalla', 'Affiliation': 'Ludwig-Maximilians-University, Department of Internal Medicine, Psychosomatic Out-Patient-Clinic, Munich, Germany; Medicover Neuroendocrinology, Munich, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Steiger', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.029']
2728,32912633,"Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, reduces endometriosis-associated pain in a dose-response manner: a randomized, double-blind, placebo-controlled study.","OBJECTIVE


To evaluate the efficacy and safety of three dose levels of relugolix, a gonadotropin-releasing hormone receptor antagonist, compared with placebo and leuprorelin in women with endometriosis-associated pain.
DESIGN


Phase 2, multicenter, randomized, double-blind, placebo-controlled study.
SETTING


Hospitals and clinics.
PATIENT(S)


Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain.
INTERVENTION(S)


During a 12-week treatment period, patients received relugolix 10 mg (n = 103), 20 mg (n = 100), or 40 mg (n = 103) as a daily oral dose; placebo (n = 97) as a daily oral dose; or leuprorelin 3.75 mg (n = 80) as a monthly subcutaneous injection.
MAIN OUTCOME MEASURE(S)


Primary endpoint was the change from baseline in mean visual analog scale score for pelvic pain during 28 days before the end of treatment.
RESULT(S)


The mean changes in mean visual analog scale score for pelvic pain were -3.8 mm in the placebo group; -6.2, -8.1, and -10.4 mm in the relugolix 10-mg, 20-mg, and 40-mg groups; respectively; and -10.6 mm in the leuprorelin group. The major adverse events with relugolix were hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease in a dose-response manner, which were also observed in the leuprorelin group with a frequency comparable with that in the relugolix 40-mg group.
CONCLUSION(S)


Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated. Relugolix 40 mg demonstrated efficacy and safety comparable with those of leuprorelin.
CLINICAL TRIAL REGISTRATION NUMBER


NCT01458301.",2020,Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated.,"['women with endometriosis-associated pain', 'Hospitals and clinics', 'Adult premenopausal women with endometriosis who had dysmenorrhea and endometriosis-associated pelvic pain']","['Relugolix, an oral gonadotropin-releasing hormone receptor antagonist', 'Relugolix', 'placebo and leuprorelin', 'placebo', 'leuprorelin', 'relugolix 10 mg', 'relugolix, a gonadotropin-releasing hormone receptor antagonist']","['mean visual analog scale score for pelvic pain', 'efficacy and safety', 'hot flush, metrorrhagia, menorrhagia, and irregular menstruation, and bone mineral density decrease', 'tolerated']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}]","[{'cui': 'C3896936', 'cui_str': 'relugolix'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0025874', 'cui_str': 'Intermenstrual bleeding - irregular'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0156404', 'cui_str': 'Irregular periods'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",103.0,0.454383,Oral administration of relugolix alleviated endometriosis-associated pain in a dose-response manner and was generally well tolerated.,"[{'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'Department of Obstetrics and Gynecology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. Electronic address: yutakaos-tky@umin.ac.jp.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Seki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Tanimoto', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentarou', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Terakawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Tottori University Faculty of Medicine, Yonago, Japan.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.07.055']
2729,32912659,Virtual grand rounds as a novel means for applicants and programs to connect in the era of COVID-19.,"BACKGROUND


COVID-19 has disrupted the 2020-2021 residency application cycle with the cancellation of away rotations and in-person interviews. This study seeks to investigate the feasibility and utility of video conferencing technology (VCT) as an opportunity for applicants to interact with faculty from outside programs.
METHODS


18 prospective urology applicants were randomized to 6 urology programs to give a virtual grand rounds (VGR) talk. Presentations were recorded and analyzed to determine audience engagement. Students were surveyed regarding perceived utility of VGR. Faculty were surveyed to determine system usability of VCT and ability to evaluate the applicant.
RESULTS


17 students completed the survey, reporting a 100% satisfaction rate with VGR. A majority felt this was a useful way to learn about outside programs. 85 physicians completed the faculty survey, with nearly half feeling confident in their ability to evaluate the applicant. Video transcription data shows sessions were interactive with minimal distractions.
CONCLUSIONS


VGR can be a useful means for medical students to express interest in programs as well as an additional marker for faculty to evaluate applicants.",2020,"This study seeks to investigate the feasibility and utility of video conferencing technology (VCT) as an opportunity for applicants to interact with faculty from outside programs.
",['18 prospective urology applicants'],['video conferencing technology (VCT'],[],"[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0042077', 'cui_str': 'Urology'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",[],,0.0399452,"This study seeks to investigate the feasibility and utility of video conferencing technology (VCT) as an opportunity for applicants to interact with faculty from outside programs.
","[{'ForeName': 'Linhan', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: linhan.xu@som.umaryland.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ambinder', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: dpa102@gmail.com.'}, {'ForeName': 'Juhye', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: juhye.kang@som.umaryland.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Faris', 'Affiliation': 'The University of Chicago Medicine, Chicago, IL, USA. Electronic address: sfaris@surgery.bsd.uchicago.edu.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Scarpato', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: kristen.r.scarpato@vumc.org.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Moy', 'Affiliation': 'University of Florida College of Medicine, Gainesville, FL, USA. Electronic address: lou.moy@urology.ufl.edu.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kobashi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, WA, USA. Electronic address: kathleen.kobashi@virginiamason.org.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Lemack', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: gary.lemack@utsouthwestern.edu.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Malik', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: rmalik@som.umaryland.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.08.044']
2730,32912725,A Pilot Randomized Trial Comparing the Effects of 80 versus 160 mg on Midtrimester Uterine Artery Pulsatility Index in Women with a History of Preeclampsia.,"OBJECTIVE


To compare the effects of 80 mg and 160 mg of aspirin, initiated in the first trimester of pregnancy, on mid-trimester uterine artery pulsatility index (UtA-PI) in women with a history of preeclampsia.
METHODS


We performed a pilot double-blind randomized controlled trial. Pregnant women with a history of preeclampsia were recruited between 10 0/7  and 13 6/7  weeks gestation and randomly assigned to take either 80 or 160 mg of aspirin daily at bedtime from randomization to 35 6/7  weeks gestation. The primary outcome was mean UtA-PI at 22-24 weeks. Secondary outcomes included the rate of fetal growth restriction and preeclampsia, stratified as term (≥37 weeks), preterm (<37 weeks), and early-onset (<34 weeks) preeclampsia.
RESULTS


A total of 107 participants were randomized, including 41 (38%) with a history of preterm preeclampsia and 16 (15%) with a history of early-onset preeclampsia. We observed no significant difference in mean UtA-PI at 22-24 weeks between the 2 groups (0.97; 95% CI 0.88-1.05 vs. 0.97; 95% CI 0.88-1.07, P = 0.9). The rates of fetal growth restriction (8% vs. 2%; P = 0.20); preeclampsia (12% vs. 15%; P = 0.78), preterm preeclampsia (4% vs. 2%; P = 0.56), and early-onset preeclampsia (0% vs. 2%; P = 0.52) were similar in both groups. No serious adverse events associated with the study treatment were reported.
CONCLUSION


We observed no significant difference in UtA-PI between the two doses of aspirin, but we observed low rates of fetal growth restriction and preterm and early-onset preeclampsia (all less than 5%). The benefits of aspirin for the prevention of preterm preeclampsia is probably not related to the improvement of deep placentation alone.",2020,"The rates of fetal growth restriction (8% vs. 2%; P = 0.20); preeclampsia (12% vs. 15%; P = 0.78), preterm preeclampsia (4% vs. 2%; P = 0.56), and early-onset preeclampsia (0% vs. 2%; P = 0.52) were similar in both groups.","['women with a history of preeclampsia', 'A total of 107 participants were randomized, including 41 (38%) with a history of preterm preeclampsia and 16 (15%) with a history of early-onset preeclampsia', 'Pregnant women with a history of preeclampsia were recruited between 10 0/7  and 13 6/7  weeks gestation', 'Women with a History of Preeclampsia']","['Midtrimester Uterine Artery Pulsatility Index', 'aspirin']","['UtA-PI', 'rate of fetal growth restriction and preeclampsia, stratified as term (≥37 weeks), preterm (<37 weeks), and early-onset (<34 weeks) preeclampsia', 'preterm preeclampsia', 'mid-trimester uterine artery pulsatility index (UtA-PI', 'mean UtA-PI', 'rates of fetal growth restriction', 'low rates of fetal growth restriction and preterm and early-onset preeclampsia', 'preeclampsia', 'early-onset preeclampsia']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4076023', 'cui_str': 'History of pre-eclampsia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",107.0,0.546728,"The rates of fetal growth restriction (8% vs. 2%; P = 0.20); preeclampsia (12% vs. 15%; P = 0.78), preterm preeclampsia (4% vs. 2%; P = 0.56), and early-onset preeclampsia (0% vs. 2%; P = 0.52) were similar in both groups.","[{'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Tapp', 'Affiliation': 'Reproduction, Mother and Child Health Unit, Research Center of the CHU de Québec - Université Laval, Québec City, QC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guerby', 'Affiliation': 'Reproduction, Mother and Child Health Unit, Research Center of the CHU de Québec - Université Laval, Québec City, QC; Department of Obstetrics, Paule de Viguier Hospital, CHU Toulouse, INSERM U1048, Toulouse, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Girard', 'Affiliation': 'Reproduction, Mother and Child Health Unit, Research Center of the CHU de Québec - Université Laval, Québec City, QC.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Roberge', 'Affiliation': 'Reproduction, Mother and Child Health Unit, Research Center of the CHU de Québec - Université Laval, Québec City, QC.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Côté', 'Affiliation': 'Department of Medicine, CHU de Québec-Université Laval, Québec City, QC.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, QC; Department of Pharmacy, CHU Ste-Justine, Montréal, QC.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Leclair', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, QC.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bujold', 'Affiliation': 'Reproduction, Mother and Child Health Unit, Research Center of the CHU de Québec - Université Laval, Québec City, QC; Department of Obstetrics, Gynecology and Reproduction, Faculty of Medicine, Université Laval, Québec City, QC. Electronic address: emmanuel.bujold@crchudequebec.ulaval.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.05.013']
2731,32912727,Taking the Leap Toward Cost-Conscious Education in Obstetrics and Gynaecology: A Preliminary Randomized Controlled Trial.,"OBJECTIVE


Residents have a professional obligation with respect to the stewardship of health care resources, yet there is a paucity of research on how to improve residents' cost-awareness. Rising health care expenditures highlight a critical need to improve education related to this competency. This study aimed to test if an educational module can teach residents to make cost-conscious decisions and reduce health care spending.
METHODS


All Canadian obstetrics and gynaecology residents in 2017 were eligible to participate in this randomized controlled trial. The study was administered online via REDCap. Interested residents were enrolled, stratified by level of training, and block randomized. Residents completed a survey to determine their management of 4 obstetrical scenarios. The intervention group reviewed an educational module on cost-effective ordering prior to completing the survey; the control group was given the option to review the module afterward. The primary outcome was mean total expenditures, compared between the 2 groups using the t test.
RESULTS


Eighty-five residents were enrolled between August and November 2017, and 63 residents from 13 Canadian residency programs completed the study requirements (33 control and 30 intervention). Mean total expenditure was CAD$291.03 (95% CI 259.38-322.68) versus CAD$192.98 (95% CI 170.67-215.29) for the control and intervention groups, respectively. These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001).
CONCLUSION


This educational module decreased expenditures by Canadian obstetrics and gynaecology residents managing hypothetical obstetrical cases. This introduces a potential curriculum innovation to improve resident education in judicious use of health care resources.",2020,"These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001).
","['Obstetrics and Gynaecology', 'Eighty-five residents were enrolled between August and November 2017, and 63 residents from 13 Canadian residency programs completed the study requirements (33 control and 30 intervention', 'Canadian obstetrics and gynaecology residents managing hypothetical obstetrical cases', 'All Canadian obstetrics and gynaecology residents in 2017 were eligible to participate']",['educational module'],"['total expenditures', 'Mean total expenditure', 'mean total expenditures']","[{'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C3542953', 'cui_str': 'Module'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",85.0,0.0785197,"These figures corresponded to a 33.69% or CAD$98.05 reduction in total expenditures (P = 0.0001).
","[{'ForeName': 'Allison Diane', 'Initials': 'AD', 'LastName': 'Edwards', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alberta, Edmonton, AB. Electronic address: allison.edwards@ualberta.ca.'}, {'ForeName': 'Fahrin', 'Initials': 'F', 'LastName': 'Rawji', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alberta, Edmonton, AB.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, AB.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Ross', 'Affiliation': 'Department of Obstetrics and Gynecology, Lois Hole Hospital for Women, University of Alberta, Edmonton, AB.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2020.04.017']
2732,32912942,"Study protocol of a multicentre, randomised, controlled trial evaluating the effectiveness of probiotic and peanut oral immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with oral immunotherapy (OIT) alone and with placebo (the PPOIT-003 study).","INTRODUCTION


Peanut allergy is the the most common cause of life-threatening food-induced anaphylaxis. There is currently no effective long-term treatment. There is a pressing need for definitive treatments that improve the quality of life and prevent fatalities. Allergen oral immunotherapy (OIT) is a promising approach, which is effective at inducing desensitisation; however, OIT has a limited ability to induce sustained unresponsiveness (SU). We have previously shown that a novel treatment comprising a combination of the probiotic  Lactobacillus rhamnosus  CGMCC 1.3724 with peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT)) is highly effective at inducing SU, with benefit persisting to 4 years after treatment cessation in the majority of initial treatment responders. Here we describe the protocol for a Phase IIb multicentre, double-blind, randomised, controlled trial (PPOIT-003) with dual primary objectives to evaluate the effectiveness of PPOIT at inducing SU (assessed at 8 weeks after treatment cessation) compared with placebo treatment and peanut OIT alone, in children with peanut allergy.
METHODS AND ANALYSIS


200 children 1 to 10 years of age with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited from three tertiary paediatric hospitals in Australia. There are three intervention arms-PPOIT, peanut OIT alone or placebo. Interventions are administered once daily for 18 months. The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group.
ETHICS AND DISSEMINATION


This study has been approved by the Human Research Ethics Committees at the Royal Children's Hospital (HREC 35246) and the Child and Adolescent Health Service (RGS 2543). Results will be published in peer-reviewed journals and disseminated via presentations at international conferences.
TRIAL REGISTRATION NUMBER


ACTRN12616000322437.",2020,"The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group.
","[""Royal Children's Hospital (HREC 35246) and the Child and Adolescent Health Service (RGS 2543"", '200 children 1 to 10 years of age with current peanut allergy confirmed by failed double-blind placebo-controlled food challenge (DBPCFC) at study screening will be recruited from three tertiary paediatric hospitals in Australia', 'children with peanut allergy compared with oral immunotherapy (OIT) alone and with', 'children with peanut allergy']","['PPOIT at inducing SU', 'placebo treatment and peanut OIT alone', 'peanut OIT (Probiotic Peanut Oral ImmunoTherapy (PPOIT', 'placebo', 'probiotic and peanut oral immunotherapy (PPOIT', 'Allergen oral immunotherapy (OIT']","['quality of life and prevent fatalities', 'proportion of children who attain 8-week SU']","[{'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085100', 'cui_str': 'Health Services, Adolescent'}, {'cui': 'C3714873', 'cui_str': 'Axenfeld-Rieger Syndrome, Type 1'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",,0.686388,"The dual primary outcomes are: (1) the proportion of children who attain 8-week SU in the PPOIT group versus placebo group and (2) the proportion of children who attain 8-week SU in the PPOIT group versus OIT group.
","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Chebar Lozinsky', 'Affiliation': ""Allergy Immunology, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Paxton', 'Initials': 'P', 'LastName': 'Loke', 'Affiliation': ""Allergy Immunology, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Orsini', 'Affiliation': ""Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'ORIGINS Project, Telethon Kids Institute, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'L Prescott', 'Affiliation': 'ORIGINS Project, Telethon Kids Institute, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Gold', 'Affiliation': 'Paediatrics, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Quinn', 'Affiliation': 'Paediatrics, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'DunnGalvin', 'Affiliation': 'School of Applied Psychology, University College Cork, Cork, Ireland.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Lk Tang', 'Affiliation': ""Allergy Immunology, Murdoch Children's Research Institute, Parkville, Victoria, Australia mimi.tang@rch.org.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035871']
2733,32912947,Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk.,"INTRODUCTION


Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.
METHODS AND ANALYSIS


Using a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCO M2012  (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.
ETHICS AND DISSEMINATION


The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.
TRIAL REGISTRATION NUMBERS


ISRCTN42704678 and NCT03750110.",2020,Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial.,"['ever-smokers aged 55-80 years registered with a general practice in Leeds', '62\u2009980 individuals']","['Low-dose computed tomography (LDCT) screening', 'invitation to community-based low-dose CT screening', 'telephone-based risk-assessment for a Lung Health Check or to usual care', 'LDCT scanning']","['health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies', 'participation rates, (2) compare the performance of PLCO M2012  (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes', 'lung cancer mortality']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0199175', 'cui_str': 'Preventive service'}, {'cui': 'C0162458', 'cui_str': 'Task Forces'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.101226,Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial.,"[{'ForeName': 'Philip Aj', 'Initials': 'PA', 'LastName': 'Crosbie', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Gabe', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Simmonds', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Rogerson', 'Affiliation': 'Department of Research and Innovation, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Department of Respiratory Medicine, City Campus, Nottingham University Hospitals, Nottingham, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Lung Cancer and Thoracic Surgery Directorate, Heart and Lung Division, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Cochrane', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Darby', 'Affiliation': 'Department of Radiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Franks', 'Affiliation': 'Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Department of Respiratory Medicine, University College London, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Macleod', 'Affiliation': 'Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Messenger', 'Affiliation': 'Leeds Centre for Personalised Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Moller', 'Affiliation': 'Thames Cancer Registry, Kings College London, London, UK.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'Division of Epidemiology and Public Health, Faculty of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Neal', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Epidemiology and Public Health, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sculpher', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Puvanendran', 'Initials': 'P', 'LastName': 'Tharmanathan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew Ej', 'Initials': 'ME', 'LastName': 'Callister', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK matthew.callister@nhs.net.'}]",BMJ open,['10.1136/bmjopen-2020-037075']
2734,32912948,Yorkshire Enhanced Stop Smoking (YESS) study: a protocol for a randomised controlled trial to evaluate the effect of adding a personalised smoking cessation intervention to a lung cancer screening programme.,"INTRODUCTION


Integration of smoking cessation (SC) into lung cancer screening is essential to optimise clinical and cost effectiveness. The most effective way to use this 'teachable moment' is unclear. The Yorkshire Enhanced Stop Smoking study will measure the effectiveness of an SC service integrated within the Yorkshire Lung Screening Trial (YLST) and will test the efficacy of a personalised SC intervention, incorporating incidental findings detected on the low-dose CT scan performed as part of YLST.
METHODS AND ANALYSIS


Unless explicitly declined, all smokers enrolled in YLST will see an SC practitioner at baseline and receive SC support over 4 weeks comprising behavioural support, pharmacotherapy and/or a commercially available e-cigarette. Eligible smokers will be randomised (1:1 in permuted blocks of random size up to size 6) to receive either an enhanced, personalised SC support package, including CT scan images, or continued standard best practice. Anticipated recruitment is 1040 smokers (January 2019-December 2020). The primary objective is to measure 7-day point prevalent carbon monoxide (CO) validated SC after 3 months. Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points. A process evaluation will explore under which circumstances and on which groups the intervention works best, test intervention fidelity and theory test the mechanisms of intervention impact.
ETHICS AND DISSEMINATION


This study has been approved by the East Midlands-Derby Research Ethics Committee (18/EM/0199) and the Health Research Authority/Health and Care Research Wales. Results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and via the YLST website.
TRIAL REGISTRATION NUMBERS


ISRCTN63825779, NCT03750110.",2020,"Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points.","['1040 smokers (January 2019-December 2020', 'Eligible smokers']","['smoking cessation (SC', 'personalised smoking cessation intervention', 'Yorkshire Enhanced Stop Smoking']","['CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}]","[{'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",,0.0385885,"Secondary outcomes include CO validated cessation at 4 weeks and 12 months, self-reported continuous cessation at 4 weeks, 3 months and 12 months, attempts to quit smoking and changes in psychological variables, including perceived risk of lung cancer, motivation to quit smoking tobacco, confidence and efficacy beliefs (self and response) at all follow-up points.","[{'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom rachael.murray@nottingham.ac.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Harriet D', 'Initials': 'HD', 'LastName': 'Quinn-Scoggins', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Grace M', 'Initials': 'GM', 'LastName': 'McCutchan', 'Affiliation': 'Division of Population Medicine, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, United Kingdom.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ashurst', 'Affiliation': 'Department of Radiology, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baldwin', 'Affiliation': 'Deaprtment of Respiratory Medicine, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Philip A J', 'Initials': 'PAJ', 'LastName': 'Crosbie', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, The University of Manchester, Wythenshawe, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Neal', 'Affiliation': 'Institute of Health Science, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Rogerson', 'Affiliation': 'Research and Innivation CSU, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Thorley', 'Affiliation': 'Division of Epidemiology & Public Health, Faculty of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Matthew Ej', 'Initials': 'ME', 'LastName': 'Callister', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.'}]",BMJ open,['10.1136/bmjopen-2020-037086']
2735,32912951,East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol.,"INTRODUCTION


Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.
METHODS AND ANALYSIS


In phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms.
ETHICS AND DISSEMINATION


This protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals.
TRIAL REGISTRATION NUMBER


NCT03670706.",2020,"The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.
",['East Midlands knee pain'],['non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care'],[],"[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",[],,0.103226,"The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored.
","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK michelle.hall@nottingham.ac.uk.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fuller', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Polykarpos Angelos', 'Initials': 'PA', 'LastName': 'Nomikos', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Millar', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Ogollah', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Valdes', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Greenhaff', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Academic Rheumatology, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Walsh', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abhishek', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, University of Nottingham, Nottingham, Nottinghamshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037760']
2736,32912952,PERSonalised Incentives for Supporting Tobacco cessation (PERSIST) among healthcare employees: a randomised controlled trial protocol.,"BACKGROUND


Smoking is the primary preventable risk factor for disease and premature mortality. It is highly addictive and cessation attempts are often unsuccessful. Incentive-based programmes may be an effective method to reach sustained abstinence. Individualisation of incentives based on personal characteristics yields potential to further increase the effectiveness of incentive-based programmes.
METHOD


A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme. The intervention under study is the provision of personalised incentives on validated smoking cessation at several time points after the smoking cessation programme. A total of 220 participants are required. Participants are randomised 1:1 into intervention (personalised incentives) or control (no incentives). All participants join the group-based programme. Incentives are provided on validated abstinence directly after the smoking cessation programme and after 3, 6 and 12 months.Incentives are provided according to four schemes:(1) Standard: total reward size €350, pay-out scheme: €50 (t=0), €50 (t=3 months), €50 (t=6 months) and €200 (t=12 months), (2) descending: total reward size €300, pay-out scheme: €150, €100, €50 and €0, (3) ascending: total reward size: €400, pay-out scheme: €0, €0, €50 and €350 and (4) deposit: total reward size €450, pay-out scheme: €50, €50, €150, €200; participants pay a €100 deposit, returned conditional on abstinence after 6 months.Advice on which incentive scheme suits participants best is based on willingness to provide a deposit, readiness to quit, nicotine dependency and long-term or short-term reward preference. Participants are free to deviate from this advice. Abstinence is validated at each time point, with 15 months of total follow-up. The primary end point is validated abstinence at 12 months. Effectiveness will be determined by intention-to-treat analysis.
ETHICS AND DISSEMINATION


The Erasmus MC Medical Ethics Committee decided that according to the Dutch Human Research Law (WMO), the protocol required no formal ethical approval. The results will be published in a peer-reviewed scientific journal and communicated to the participants.
TRIAL REGISTRATION NUMBER


Netherlands Trial Register NL7711.",2020,"METHOD


A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme.","['healthcare employees', '220 participants are required', 'healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme', '€50 (t=6 months) and €200 (t=12 months), (2) descending: total reward size €300, pay-out scheme: €150, €100, €50 and €0, (3) ascending: total reward size: €400, pay-out scheme: €0, €0, €50 and €350 and (4) deposit: total reward size €450, pay-out scheme: €50, €50, €150, €200; participants pay a €100 deposit, returned conditional on abstinence after 6 months']",['intervention (personalised incentives) or control (no incentives'],[],"[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],220.0,0.138195,"METHOD


A randomised controlled trial among healthcare workers recruited through their employer and signed up for a group-based smoking cessation programme.","[{'ForeName': 'Nienke W', 'Initials': 'NW', 'LastName': 'Boderie', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes Lw', 'Initials': 'JL', 'LastName': 'van Kippersluis', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Diarmaid T', 'Initials': 'DT', 'LastName': 'Ó Ceallaigh', 'Affiliation': 'Erasmus School of Economics, Erasmus University Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Márta K', 'Initials': 'MK', 'LastName': 'Radó', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Burdorf', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'van Lenthe', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Jasper V', 'Initials': 'JV', 'LastName': 'Been', 'Affiliation': 'Department of Public Health, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands j.been@erasmusmc.nl.'}]",BMJ open,['10.1136/bmjopen-2020-037799']
2737,32904830,Through Benevolent Eyes: the Differential Efficacy of Perspective Taking and Cognitive Reappraisal on the Regulation of Shame.,"Difficulties in regulating feelings of shame is a risk factor for the onset and recurrence of mental health disorders. The present research investigated the impact of the individual differences in propensity to experience shame (or shame-proneness) on two emotion regulation strategies-perspective taking and positive reappraisal. A total of 228 participants, undergraduate students, were allocated randomly to one of the eight experimental conditions. The results revealed that for high shame-prone participants, the use of perspective taking, without positive reappraisal, led to a heightened experience of shame. In contrast, the combination of perspective taking and positive reappraisal led to reductions in shame among high shame-prone participants. The findings highlight the relationship between individual differences, and the separate and combined effects of affect regulation strategies on the experience of shame.",2020,"In contrast, the combination of perspective taking and positive reappraisal led to reductions in shame among high shame-prone participants.","['228 participants, undergraduate students']",['Perspective Taking and Cognitive Reappraisal'],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C1515187', 'cui_str': 'Take'}]",[],228.0,0.0280806,"In contrast, the combination of perspective taking and positive reappraisal led to reductions in shame among high shame-prone participants.","[{'ForeName': 'Govind', 'Initials': 'G', 'LastName': 'Krishnamoorthy', 'Affiliation': 'University of Southern Queensland, 11 Salisbury Road, Ipswich, Queensland 4305 Australia.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': 'Griffith University, 176 Messines Ridge Road, Mount Gravatt, Queensland 4122 Australia.'}, {'ForeName': 'Analise', 'Initials': 'A', 'LastName': ""O'Donovan"", 'Affiliation': 'Griffith University, 176 Messines Ridge Road, Mount Gravatt, Queensland 4122 Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'McDermott', 'Affiliation': 'James Cook University, James Cook Drive, Douglas, Queensland 4814 Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Mullens', 'Affiliation': 'University of Southern Queensland, 11 Salisbury Road, Ipswich, Queensland 4305 Australia.'}]",International journal of cognitive therapy,['10.1007/s41811-020-00085-4']
2738,32904844,Promoting physical activity in geriatric patients with cognitive impairment after discharge from ward-rehabilitation: a feasibility study.,"The aim of the present study was to examine adherence and acceptance of a home-based program to promote physical activity (PA) in older persons with cognitive impairment (CI) following inpatient rehabilitation. Sixty-three older persons (≥ 65 years) with mild to moderate CI (Mini-Mental State Examination score 17-26), allocated to the intervention group of a randomized, controlled intervention trial underwent a 12-week home-based PA intervention including (1) physical training and outdoor walking to improve functional fitness and (2) motivational strategies (goal-setting, pedometer-based self-monitoring, social support delivered by home visits, phone calls) to promote PA. Training logs were used to assess adherence to physical training, outdoor walking and to motivational strategies (goal-setting, pedometer-based self-monitoring). Acceptance (subjective feasibility and effectiveness) of the program components was assessed by a standardized questionnaire. Mean adherence rates over the intervention period were 63.6% for physical training, 57.9% for outdoor walking, and between 40.1% (achievement of walking goals), and 60.1% (pedometer-based self-monitoring) for motivational strategies. Adherence rates significantly declined from baseline to the end of intervention (T1: 43.4-76.8%, T2: 36.1-51.5%,  p values <.019). Most participants rated physical training, outdoor walking, goal-setting, and pedometer self-monitoring as feasible (68.2-83.0%) and effective (63.5-78.3%). Highest ratings of self-perceived effectiveness were found for home visits (90.6%) and phone calls (79.2%). The moderate to high adherence to self-performed physical training and motivational strategies proved the feasibility of the home-based PA program in older persons with CI following inpatient rehabilitation.",2020,Highest ratings of self-perceived effectiveness were found for home visits (90.6%) and phone calls (79.2%).,"['older persons with cognitive impairment (CI) following inpatient rehabilitation', 'Sixty-three older persons (≥ 65\xa0years) with mild to moderate CI (Mini-Mental State Examination score 17-26', 'older persons with CI following inpatient rehabilitation', 'geriatric patients with cognitive impairment after discharge from ward-rehabilitation']","['12-week home-based PA intervention including (1) physical training and outdoor walking to improve functional fitness and (2) motivational strategies (goal-setting, pedometer-based self-monitoring, social support delivered by home visits, phone calls) to promote PA', 'physical training, outdoor walking and to motivational strategies (goal-setting, pedometer-based self-monitoring', 'home-based program to promote physical activity (PA']","['physical training, outdoor walking, goal-setting, and pedometer self-monitoring as feasible', 'Mean adherence rates', 'Acceptance (subjective feasibility and effectiveness', 'Adherence rates']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584528', 'cui_str': 'Discharge from ward'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",63.0,0.013537,Highest ratings of self-perceived effectiveness were found for home visits (90.6%) and phone calls (79.2%).,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eckert', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Rohrbacher Str. 149, 69126 Heidelberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bongartz', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Rohrbacher Str. 149, 69126 Heidelberg, Germany.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Ullrich', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Rohrbacher Str. 149, 69126 Heidelberg, Germany.'}, {'ForeName': 'Bastian', 'Initials': 'B', 'LastName': 'Abel', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Rohrbacher Str. 149, 69126 Heidelberg, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Christian', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Rohrbacher Str. 149, 69126 Heidelberg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Kiss', 'Affiliation': 'Department of Health and Social Affairs FHM Bielefeld, University of Applied Sciences, Ravensberger Str. 10G, 33602 Bielefeld, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hauer', 'Affiliation': 'AGAPLESION Bethanien Hospital Heidelberg, Geriatric Centre at the University of Heidelberg, Rohrbacher Str. 149, 69126 Heidelberg, Germany.'}]",European journal of ageing,['10.1007/s10433-020-00555-w']
2739,32904962,Assessing effectiveness of regular repositioning in preventing pressure ulcers in children.,"Pressure ulcers have adverse effects on health. Thus, early detection of damage to skin integrity is important for preventing the occurrence of pressure sores. Meanwhile, two-hourly repositioning is a nursing intervention performed to prevent pressure ulcers. This study aimed to evaluate the implementation of regular repositioning for preventing pressure sores. The Braden Q Scale is an instrument that predicts skin breakdown caused by pressure ulcers. The designs used  quasi-experiment pretest  and  posttest nonequivalent control group ; 93 participants were selected through a nonprobability sampling technique by consecutive sampling (43 for the intervention group and 50 for the control group). Respondents in the intervention group were repositioned every 2 hours, and the control group received pressure mattress, which is done for 14 days or until the child can go home. The findings suggest that there is a significant difference in the Braden Q scores from before and after repositioning of the intervention group and the control group using pressure mattress (P<0.001). Nurses are expected to be able to detect early damage to skin integrity and to implement regular repositioning by using the Braden Q Scale.",2020,Nurses are expected to be able to detect early damage to skin integrity and to implement regular repositioning by using the Braden Q Scale.,['children'],"['regular repositioning', 'control group received pressure mattress']",['Braden Q scores'],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",93.0,0.0176,Nurses are expected to be able to detect early damage to skin integrity and to implement regular repositioning by using the Braden Q Scale.,"[{'ForeName': 'Rifka Putri', 'Initials': 'RP', 'LastName': 'Andayani', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia.'}, {'ForeName': 'Nani', 'Initials': 'N', 'LastName': 'Nurhaeni', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia.'}, {'ForeName': 'Dessie', 'Initials': 'D', 'LastName': 'Wanda', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia.'}]",Pediatric reports,['10.4081/pr.2020.8696']
2740,32904985,Effect of Chlorhexidine on durability of two self-etch adhesive systems.,"Background


Despite of the rapid development in the field of dental adhesives, the issue of reduction in dentin bond durability has still not been resolved. The activity of dentinal endogenous enzymes such as MMPs is one of the most important causes of failure in resin composite restorations. The aim of this study was to investigate the influence of Chlorhexidine on micro-tensile bond strength of two types of commercially available self-etch adhesives.
Material and Methods


Twenty four sound and freshly extracted molars were selected. Four standardized flat mid-coronal dentinal disks were prepared from each tooth. The specimens were randomly assigned to 6 groups (n=16). Groups A(control group) and B were treated with Clearfill SE Bond based on the manufacturer's instructions. Groups C and D were treated with 2% Chlorhexidine 60 seconds before applying Clearfill SE Bond. Groups E and F were treated with Peak Universal Bond according to the manufacturer's instructions. All groups were stored in distilled water in room temperature. Microtensile bond strength in groups A, C, and E were tested 24 hours after preparation, while microtensile bond strength in groups B, D, and F were tested after 3 months storage and 3000 thermal cycles(5-55 °C). Statistical analysis was performed with SPSS 20 and µTBS test results were analyzed using the Two-way ANOVA test.
Results


µTBS was not significantly different between groups A, C, and E after 24 hours ( P >0.5). There was no significant difference between groups B (Clearfill SE Bond + Aging) and D (Clearfill SE Bond + 2% CHX + Aging). The Peak Universal µTBS significantly decreased after the aging procedure ( P <0.001).
Conclusions


Based on the findings of this study, pretreatment with 2% CHX had no negative effect on the Clearfill SE Bond µTBS. However the µTBS of 0.2% CHX contained Peak Universal adhesive decreased significantly after aging.  Key words: Self-etch adhesives, Micro-tensile bond strength, chlorhexidine, bond durability.",2020,"Results


µTBS was not significantly different between groups A, C, and E after 24 hours ( P >0.5).",['Material and Methods\n\n\nTwenty four sound and freshly extracted molars were selected'],"['Chlorhexidine', 'Clearfill SE']","['µTBS', 'Clearfill SE Bond µTBS', 'Peak Universal µTBS', 'Microtensile bond strength', 'Peak Universal adhesive']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}]",,0.0215629,"Results


µTBS was not significantly different between groups A, C, and E after 24 hours ( P >0.5).","[{'ForeName': 'Haleh', 'Initials': 'H', 'LastName': 'Kazemi-Yazdi', 'Affiliation': 'DDS, MSc, Specialist in Operative Dentistry, Associate Professor, Operative Dentistry Department, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Mahdieh', 'Initials': 'M', 'LastName': 'Saeed-Nezhad', 'Affiliation': 'DDS, Private Office, Tehran, Iran.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'DDS, Postgraduate Student of Operative Dentistry, Operative Dentistry Department, Faculty of Dentistry, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56873']
2741,32904997,The use of breastfeeding pillow to reduce discomfort for breastfeeding mothers.,"The process of breastfeeding for newborns in the special care room often experiences obstacles due to diverse factors, such as environmental factors, hospitalization impact, and maternal discomfort during breastfeeding. The aim of this study was to determine whether breastfeeding pillows decrease maternal discomfort during breastfeeding. This research employed a randomized control trial (RCT) design involving 70 participants who were divided into an intervention (n=35) and a control group (n=35) based on the inclusion criteria. The intervention group used a breastfeeding pillow while breastfeeding the baby, and the control group provided ASI (breast milk) as recommended in the treatment room. The data measurement instruments were an observation sheet and the body part discomfort scale (BPDS). The BPDS comprised 4 assessments: the initial assessment, day I assessment, day II assessment, and the final assessment. The results of the GLM-RM analysis showed a significant reduction in maternal discomfort among participants using breastfeeding pillows (P<0.05). Supporting facilities such as breastfeeding pillows are needed to improve maternal comfort to increase the breastfeeding period and ensure optimal nutrition.",2020,The results of the GLM-RM analysis showed a significant reduction in maternal discomfort among participants using breastfeeding pillows (P<0.05).,"['70 participants who were divided into an intervention (n=35) and a control group (n=35) based on the inclusion criteria', 'breastfeeding mothers']","['breastfeeding pillow while breastfeeding the baby, and the control group provided ASI (breast milk']","['maternal discomfort', 'body part discomfort scale (BPDS']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0182291', 'cui_str': 'Pillow'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0229962', 'cui_str': 'Body part structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",70.0,0.0177661,The results of the GLM-RM analysis showed a significant reduction in maternal discomfort among participants using breastfeeding pillows (P<0.05).,"[{'ForeName': 'Ida Ayu Kade', 'Initials': 'IAK', 'LastName': 'Sri Widiastuti', 'Affiliation': 'Faculty of Nusing, Universitas Indonesia.'}, {'ForeName': 'Yeni', 'Initials': 'Y', 'LastName': 'Rustina', 'Affiliation': 'Faculty of Nusing, Universitas Indonesia.'}, {'ForeName': 'Defi', 'Initials': 'D', 'LastName': 'Efendi', 'Affiliation': 'Faculty of Nusing, Universitas Indonesia.'}]",Pediatric reports,['10.4081/pr.2020.8702']
2742,32905094,Directly Mailing gFOBT Kits to Previous Responders Being Recalled for Colorectal Cancer Screening Increases Participation.,"Background


Colorectal cancer (CRC) screening with guaiac fecal occult blood test (gFOBT) reduces CRC-related death. Average risk individuals should be recalled for screening with gFOBT every 2 years in order to maximize effectiveness. However, adherence with repeated testing is often suboptimal. Our aim was to evaluate whether adding a gFOBT kit to a mailed recall letter improves participation compared with a mailed recall letter alone, among previous responders to a mailed invitation.
Methods


We conducted a cluster randomized controlled trial, with the primary care provider as the unit of randomization. Eligible patients had completed a gFOBT and tested negative in an earlier pilot study and were now due for recall. The intervention group received a mailed CRC screening recall letter from their primary care provider plus a gFOBT kit ( n  = 431) while the control group received a mailed CRC screening mailed recall letter alone ( n  = 452). The primary outcome was the uptake of gFOBT or colonoscopy within 6 months.
Results


gFOBT uptake was higher in the intervention group (61.3%,  n  = 264) compared with the control group (50.4%,  n  = 228) with an absolute difference between the two groups of 10.8% (95% confidence interval [CI]: 1.4 to 20.2%,  P  = <0.01). Patients in the intervention group were more likely to complete the gFOBT compared with the control group (odds ratio [OR] = 1.4; 95% CI: 1.1 to 1.9).
Conclusion


Our findings show that adding gFOBT kits to the mailed recall letter increased participation among persons recalled for screening. Nine gFOBT kits would have to be sent by mail in order to screen one additional person.",2020,"Results


gFOBT uptake was higher in the intervention group (61.3%,  n  = 264) compared with the control group (50.4%,  n  = 228) with an absolute difference between the two groups of 10.8% (95% confidence interval [CI]: 1.4 to 20.2%,  P  = <0.01).",['Eligible patients had completed a gFOBT and tested negative in an earlier pilot study and were now due for recall'],"['gFOBT kits', 'gFOBT kit', '\n\n\nColorectal cancer (CRC) screening with guaiac fecal occult blood test (gFOBT', 'mailed CRC screening recall letter from their primary care provider plus a gFOBT kit ( n  = 431) while the control group received a mailed CRC screening mailed recall letter alone']","['gFOBT uptake', 'likely to complete the gFOBT', 'uptake of gFOBT or colonoscopy within 6 months']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]","[{'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205171', 'cui_str': 'Singular'}]","[{'cui': 'C0018302', 'cui_str': 'Guaiac'}, {'cui': 'C0201811', 'cui_str': 'Screening for occult blood in feces'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0598084,"Results


gFOBT uptake was higher in the intervention group (61.3%,  n  = 264) compared with the control group (50.4%,  n  = 228) with an absolute difference between the two groups of 10.8% (95% confidence interval [CI]: 1.4 to 20.2%,  P  = <0.01).","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Tinmouth', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Jigisha', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Austin', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nancy N', 'Initials': 'NN', 'LastName': 'Baxter', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Brouwers', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Earle', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Levitt', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Critical Care Services Ontario, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'MacKinnon', 'Affiliation': 'Cancer Care Ontario, Toronto, Ontario, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Paszat', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Rabeneck', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}]",Journal of the Canadian Association of Gastroenterology,['10.1093/jcag/gwz012']
2743,32905105,Squeezing a squishy object effectively controls pain in children during intravenous catheter insertion.,"This study aimed to identify the effect of distraction technique involving squeezing a squishy object on pain in children during intravenous catheter insertion. In this work, the control group posttest-only quasiexperimental design was used. This study involved 50 participants aged 3-15 years and was assigned into either intervention or control group. The intervention group was provided with a squishy object to squeeze as a form of distraction during intravenous catheter insertion, whereas the control group received the standard intervention. The pain was measured by using the Wong- Baker Faces Scale for 3-8 years old and the Visual Analog Scale or Numeric Rating Scale for children older than 8 years. Mann-Whitney analysis reveals significant difference in pain level between the intervention and control groups (P<0,001; α=0.05). The distraction technique involving squeezing a squishy object effectively reduced pain in children during intravenous catheter insertion and is recommended for pain management in nursing care in the pediatric ward.",2020,"Mann-Whitney analysis reveals significant difference in pain level between the intervention and control groups (P<0,001; α=0.05).","['children during intravenous catheter insertion', '50 participants aged 3-15 years']","['distraction technique involving squeezing a squishy object', 'standard intervention']","['pain level', 'Visual Analog Scale or Numeric Rating Scale', 'pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0745442', 'cui_str': 'Venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",50.0,0.033493,"Mann-Whitney analysis reveals significant difference in pain level between the intervention and control groups (P<0,001; α=0.05).","[{'ForeName': 'Grace Yuliona', 'Initials': 'GY', 'LastName': 'Sirtin Tumakaka', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia.'}, {'ForeName': 'Nani', 'Initials': 'N', 'LastName': 'Nurhaeni', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia.'}, {'ForeName': 'Dessie', 'Initials': 'D', 'LastName': 'Wanda', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia.'}]",Pediatric reports,['10.4081/pr.2020.8692']
2744,32912828,Research with youth of color in low-income communities: Strategies for recruiting and retaining participants.,"BACKGROUND


Youth of color from low-income urban communities are crucial participants in research, as their involvement can shape effective, culturally responsive interventions and policy to promote youth health and well-being. These young people, however, are an often-neglected research population, due in part to perceived challenges associated with their inclusion as well as marginalized communities' justifiable mistrust of research.
OBJECTIVES


Based on our experience conducting a school-based randomized intervention trial in Baltimore, Maryland, we present strategies for conducting research with low-income, urban youth of color. We discuss strategies in three domains: university-community partnership development, participant recruitment, and participant retention.
METHODS


We reviewed partnership building and recruitment strategies employed by our team across four years of trial implementation and evaluated success of participant retention at our final survey timepoint.
RESULTS


Partnership building was facilitated by selection of a study design that maximized benefits for all participants, promotion of capacity building at partner institutions, and attention to research staff hiring and training practices. Effective study recruitment strategies included personal contact with parents and close cooperation between school personnel and study staff. Providing incentives and collecting multiple types of participant contact information contributed to increased retention rates. On average, those who participated in the final survey timepoint were less likely to be male and Latinx and exhibited more favorable baseline mental health than those who did not, suggesting differential attrition based on youth characteristics.
CONCLUSIONS


Lessons learned from this school-based trial can be applied more broadly to research with low-income urban youth of color. Researchers should strive to maximize scientific rigor, minimize harm to vulnerable adolescents and their communities, promote positive research experiences for young people, and provide concrete benefits to those who participate.",2020,"RESULTS


Partnership building was facilitated by selection of a study design that maximized benefits for all participants, promotion of capacity building at partner institutions, and attention to research staff hiring and training practices.","['Youth of color from low-income urban communities', 'personal contact with parents and close cooperation between school personnel and study staff', 'conducting research with low-income, urban youth of color']",[],"['favorable baseline mental health', 'retention rates']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0469221,"RESULTS


Partnership building was facilitated by selection of a study design that maximized benefits for all participants, promotion of capacity building at partner institutions, and attention to research staff hiring and training practices.","[{'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Mendelson', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, United States. Electronic address: tmendel1@jhu.edu.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Sheridan', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, United States.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Clary', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Department of Mental Health, United States.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.08.011']
2745,32912861,Association of heated tobacco product use with smoking cessation in Chinese cigarette smokers in Hong Kong: a prospective study.,"INTRODUCTION


Heated tobacco products (HTPs) are increasingly popular worldwide, but whether they aid or undermine cigarette abstinence remains uncertain. We examined the predictors of HTP initiation and the prospective association of HTP use with cigarette abstinence in community-based smokers in Hong Kong.
DESIGN


Secondary analysis of a randomised clinical trial aimed to evaluate the effectiveness of brief advice and referral for smoking cessation. The interventions were not related to HTP use.
PARTICIPANTS AND SETTINGS


1213 carbon monoxide-verified daily cigarette smokers with intentions to quit or reduce smoking proactively recruited from community sites throughout Hong Kong MAIN EXPOSURE: Current (past 7 day) use of HTP at baseline.
MAIN OUTCOME


Self-reported 7-day point-prevalence cigarette abstinence at 6 months (exclusive use of HTP permitted).
RESULTS


At baseline, 201 (16.6%) and 60 (4.9%) were ever and current HTP users, respectively. During the 6-month follow-up period, 110 of 1012 (10.9%) never users at baseline initiated HTPs. Younger age and higher education significantly predicted initiation. After adjusting for sociodemographic, smoking-related and quitting-related factors, current HTP use at baseline was not associated with cigarette abstinence at 6 months (adjusted prevalence ratio (aPR) 1.08, 95% CI 0.63 to 1.85). The results were similar in persistent users from baseline to 1-month/3-month follow-up (vs non-users; aPR 1.14, 95% CI 0.57 to 2.29). Use of smoking cessation service between baseline and 3-month follow-up significantly predicted cigarette abstinence (aPR 1.70, 95% CI 1.26 to 2.30).
CONCLUSION


HTP use was not associated with cigarette abstinence at 6 months in a community-based cohort of smokers with intentions to quit or reduce smoking. Trial registration details ClinicalTrials.gov, NCT03565796.",2020,"Use of smoking cessation service between baseline and 3-month follow-up significantly predicted cigarette abstinence (aPR 1.70, 95% CI 1.26 to 2.30).
","['Chinese cigarette smokers in Hong Kong', '1213 carbon monoxide-verified daily cigarette smokers with intentions to quit or reduce smoking proactively recruited from community sites throughout Hong Kong MAIN EXPOSURE', 'community-based smokers in Hong Kong']","['Heated tobacco products (HTPs', 'heated tobacco product use with smoking cessation']","['cigarette abstinence', 'smoking cessation service', 'Self-reported 7-day point-prevalence cigarette abstinence at 6 months (exclusive use of HTP permitted']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}]",,0.0740417,"Use of smoking cessation service between baseline and 3-month follow-up significantly predicted cigarette abstinence (aPR 1.70, 95% CI 1.26 to 2.30).
","[{'ForeName': 'Tzu Tsun', 'Initials': 'TT', 'LastName': 'Luk', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yongda Socrates', 'Initials': 'YS', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Hiu Laam', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ching Yin', 'Initials': 'CY', 'LastName': 'Lau', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Anthony Cho-Shing', 'Initials': 'AC', 'LastName': 'Kwong', 'Affiliation': 'Hong Kong Council on Smoking and Health, Hong Kong, China.'}, {'ForeName': 'Vienna Wai-Yin', 'Initials': 'VW', 'LastName': 'Lai', 'Affiliation': 'Hong Kong Council on Smoking and Health, Hong Kong, China.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Man Ping', 'Initials': 'MP', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China mpwang@hku.hk.'}]",Tobacco control,['10.1136/tobaccocontrol-2020-055857']
2746,32912989,Bariatric surgery and LDL cholesterol (BASALTO) trial study protocol: randomised controlled study evaluating the effect of gastric bypass versus sleeve gastrectomy on high LDL cholesterol.,"INTRODUCTION


Observational studies have shown gastric bypass to be superior to sleeve gastrectomy in terms of low-density lipoprotein (LDL) cholesterol improvement. If these results are confirmed in randomised controlled trials, presurgical LDL cholesterol status could be a relevant factor in surgical procedure election. Furthermore, it is also necessary to establish the mechanisms by which LDL cholesterol improves after surgery and whether qualitative and quantitative changes occur in the different lipoprotein subclasses. The first objective is to ascertain whether high LDL cholesterol levels before surgery can be considered an additional factor when selecting the most appropriate surgical procedure for each patient (gastric bypass or sleeve gastrectomy). Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared. Secondary objectives were (1) to compare changes in other lipoproteins and LDL composition and (2) to study the pathophysiologic mechanisms related to LDL cholesterol remission.
METHODS AND ANALYSIS


A randomised clinical trial, with intention-to-treat analysis, will be conducted to compare LDL cholesterol remission between gastric bypass and sleeve gastrectomy, with a 12-month follow-up. Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40 kg/m 2  or ≥35 kg/m 2  with significant obesity-related comorbidity and high LDL cholesterol levels. Patients will be evaluated preoperatively and at 3, 6 and 12 months after bariatric surgery. Examinations will include routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation.
ETHICS AND DISSEMINATION


Ethics approval has been granted by the Parc de Salut Mar Ethics Committee (2019/8471/I). The study and its conclusions regarding the primary and secondary objectives will be presented as manuscripts submitted for peer-reviewed journal publication.
TRIAL REGISTRATION NUMBER


NCT03975478.",2020,"Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared.","['patients with morbid obesity', 'Inclusion criteria will be patients between 18 and 60 years of age with body mass index ≥40']","['gastric bypass versus sleeve gastrectomy', 'gastric bypass and sleeve gastrectomy', 'Bariatric surgery and LDL cholesterol']","['low-density lipoprotein (LDL) cholesterol improvement', 'routine blood chemistry, anthropometric measurements, food intake recall, physical activity questionnaires and serum samples for lipidomic and lipoprotein characterisation', 'LDL cholesterol remission', '1-year remission rates of high LDL cholesterol', 'obesity-related comorbidity and high LDL cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005774', 'cui_str': 'Blood chemistry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0151691', 'cui_str': 'High density lipoprotein decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0811776,"Hence, the 1-year remission rates of high LDL cholesterol after gastric bypass and sleeve gastrectomy in patients with morbid obesity will be compared.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benaiges', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain 96002@parcdesalutmar.cat.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Goday', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Juana A', 'Initials': 'JA', 'LastName': 'Flores-Le Roux', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': ""Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Pozo', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Rodríguez-Morató', 'Affiliation': ""Integrative Pharmacology and Systems Neuroscience Research Group, Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Serra', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Pera', 'Affiliation': 'Department of General Surgery, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Llauradó', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Elisenda', 'Initials': 'E', 'LastName': 'Climent', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': ""Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.""}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Ramon', 'Affiliation': 'Department of General Surgery, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pedro-Botet', 'Affiliation': 'Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-037712']
2747,32913018,"LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF FREMANEZUMAB IN MIGRAINE: A RANDOMIZED STUDY.","OBJECTIVE


To assess the long-term safety, tolerability, and efficacy of fremanezumab, a fully humanized monoclonal antibody approved for the preventive treatment of migraine.
METHODS


A 52-week, multicenter, randomized, double-blind, parallel-group study evaluated fremanezumab monthly or quarterly in adults with chronic migraine (CM) or episodic migraine (EM). Safety and tolerability were assessed by adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments (immediately and 1 hour post-injection), laboratory/vitals assessments, and immunogenicity testing. Prespecified exploratory evaluations included change from baseline in the monthly number of: migraine days, headache days of at least moderate severity, and days with any acute headache medication use, respectively. Change from baseline in headache-related disability (HIT-6 scores) was also measured.
RESULTS


Of 1890 patients enrolled, 551 and 559 CM patients received quarterly and monthly dosing; 394 and 386 EM patients received quarterly or monthly, respectively. The most commonly reported AEs were injection-site reactions (induration [33%], pain [31%], and erythema [26%]). Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months. Reductions in any acute headache medication use and headache-related disability were also maintained over 12 months.
CONCLUSIONS


Fremanezumab quarterly and monthly were well tolerated and demonstrated sustained improvements in monthly migraine days, headache days, and headache-related disability for up to 12 months in patients with migraine.ClinicalTrials.gov: NCT02638103 CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that long-term fremanezumab treatment is safe, well tolerated, and effective at sustaining reductions in monthly migraine and headache days.",2020,"Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months.","['adults with chronic migraine (CM) or episodic migraine (EM', '1890 patients enrolled']","['Fremanezumab', 'fremanezumab']","['Safety and tolerability', 'laboratory/vitals assessments, and immunogenicity testing', 'monthly number of: migraine days, headache days of at least moderate severity, and days with any acute headache medication use, respectively', 'monthly migraine days, headache days, and headache-related disability', 'acute headache medication use and headache-related disability', 'headache-related disability (HIT-6 scores', 'headache days of at least moderate severity', 'adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}]",1890.0,0.16836,"Fremanezumab reduced monthly migraine days (CM quarterly, -7.2 days; CM monthly, -8.0 days; EM quarterly, -5.2 days; EM monthly, -5.1 days) and headache days of at least moderate severity (CM quarterly, -6.4 days; CM monthly, -6.8 days; EM quarterly, -4.4; EM monthly, -4.2 days) from baseline to 12 months.","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Ning', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': ""Peter J. Goadsby, NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK.""}]",Neurology,['10.1212/WNL.0000000000010600']
2748,32913021,Effect of escitalopram dose and treatment duration on CSF Aβ levels in healthy older adults: A controlled clinical trial.,"OBJECTIVE


To determine whether compared with placebo, treatment with escitalopram (ESC) would lower CSF (CSF) amyloid beta 42 (Aβ 42 ) levels.
RATIONALE


Serotonin signaling suppresses Aβ 42  in animal models of Alzheimer's disease (AD) and young healthy humans. In a prospective study in older adults, we examined dose and treatment duration effects of ESC.
METHODS


Using lumbar punctures (LPs) to sample CSF levels before and after a course of ESC treatment, cognitively normal older adults (n = 114) were assigned to either: placebo; 20 mg ESC × 2 weeks; 20 mg ESC × 8 weeks or 30 mg ESC × 8 weeks with CSF sampled pre- and post-treatment and within-subject percent change in Aβ 42  was used as the primary outcome in subsequent analyses.
RESULTS


An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81). Positive baseline amyloid-beta status (CSF Aβ 42  levels <250 pg/mL) was associated with smaller Aβ 42  reduction ( p  = 0.006; 95% CI [-16.7% to 0.5%];  d  = -0.52) compared with negative baseline amyloid status (CSF Aβ 42  levels >250 pg/mL).
CONCLUSIONS


Short-term longitudinal doses of ESC decreased CSF Aβ 42  in cognitively normal older adults, the target group for AD prevention.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that for cognitively normal older adults, ESC decreases CSF Aβ 42 .
CLINICAL TRIAL IDENTIFIER


NCT02161458.",2020,An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81).,"['older adults', 'healthy older adults', 'cognitively normal older adults (n = 114', ""42  in animal models of Alzheimer's disease (AD) and young healthy humans"", 'cognitively normal older adults, ESC decreases CSF Aβ 42 ', 'cognitively normal older adults']","['ESC treatment', 'ESC', 'placebo, treatment with escitalopram (ESC', 'placebo; 20 mg ESC', 'escitalopram', 'placebo']","['Positive baseline amyloid-beta status ', 'CSF (CSF) amyloid beta 42 (Aβ 42 ) levels', 'CSF Aβ levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0012644', 'cui_str': 'Animal Disease Models'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",114.0,0.0976057,An overall 9.4% percentage point greater reduction in CSF Aβ 42  was found in ESC treated compared with placebo treated groups ( p  < 0.001; 95% CI [4.9%-14.2%];  d  = 0.81).,"[{'ForeName': 'Yvette I', 'Initials': 'YI', 'LastName': 'Sheline', 'Affiliation': 'Departments of Psychiatry, Radiology and Neurology, University of Pennsylvania, Philadelphia PA sheline@pennmedicine.upenn.edu.'}, {'ForeName': 'B Joy', 'Initials': 'BJ', 'LastName': 'Snider', 'Affiliation': 'Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis MO.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Beer', 'Affiliation': 'Department of Biostatistics, Epidemiology and Bioinformatics, University of Pennsylvania, Philadelphia PA.'}, {'ForeName': 'Darsol', 'Initials': 'D', 'LastName': 'Seok', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia PA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis MO.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'New York State Psychiatric Institute, and Department of Psychiatry, Columbia University, New York, NY.'}, {'ForeName': 'Jin-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis MO.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Waligorska', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia PA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korecka', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia PA.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Aselcioglu', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia PA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Morris', 'Affiliation': 'Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis MO.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Shaw', 'Affiliation': 'Department of Pathology, University of Pennsylvania, Philadelphia PA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cirrito', 'Affiliation': 'Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis MO.'}]",Neurology,['10.1212/WNL.0000000000010725']
2749,32913029,Association of systemic secondary brain insults and outcome in patients with convulsive status epilepticus: A post-hoc study of a randomized controlled trial.,"OBJECTIVE


To evaluate the association between systemic factors (mean arterial blood pressure, arterial partial pressures of carbon dioxide and oxygen, body temperature, natremia, and glycemia) on day-1 and neurologic outcomes 90 days after convulsive status epilepticus.
METHODS


Post hoc analysis of the HYBERNATUS multicenter open-label controlled trial that randomized 270 critically ill patients with convulsive status epilepticus requiring mechanical ventilation to therapeutic hypothermia (32-34°C for 24 hours) plus standard care or standard care alone, between March 2011 and January 2015. The primary endpoint was a Glasgow Outcome Scale score of 5, defining a favorable outcome, 90 days after convulsive status epilepticus.
RESULTS


The 172 men and 93 women had a median age of 57 years (45-68). Among them, 130 (49%) had a previous history of epilepsy and 59 (29%) a primary brain insult. Convulsive status epilepticus was refractory in 86 (32%) patients and total seizure duration was 67 minutes (35-120). The 90-day outcome was unfavorable in 126 (48%) patients. By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85;  p  = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85;  p  = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00;  p  = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59;  p  = 0.04).
CONCLUSIONS


In our population, systemic secondary brain insults were not associated with outcome in critically ill patients with convulsive status epilepticus.
CLINICAL TRAILS REGISTRATION


ClinicalTrials.gov registration #NCT01359332.",2020,"By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85;  p  = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85;  p  = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00;  p  = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59;  p  = 0.04).
","['270 critically ill patients with convulsive status epilepticus requiring mechanical ventilation to therapeutic hypothermia (32-34°C for 24 hours) plus standard care or standard care alone, between March 2011 and January 2015', 'patients with convulsive status epilepticus', '172 men and 93 women had a median age of 57 years (45-68']",[],"['Glasgow Outcome Scale score of 5, defining a favorable outcome, 90 days after convulsive status epilepticus', 'total seizure duration', 'refractory convulsive status epilepticus', 'previous history of epilepsy', 'systemic factors (mean arterial blood pressure, arterial partial pressures of carbon dioxide and oxygen, body temperature, natremia, and glycemia', 'bystander-witnessed seizure onset']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3536587', 'cui_str': 'Grand mal status epilepticus, refractory'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455511', 'cui_str': 'H/O: epilepsy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",270.0,0.281843,"By multivariate analysis, none of the systemic secondary brain insults was associated with outcome; achieving an unfavorable outcome was associated with age above 65 years (OR, 2.17; 95% CI, 1.20-3.85;  p  = 0.01), refractory convulsive status epilepticus (OR, 2.00; 95% CI, 1.04-3.85;  p  = 0.04), and primary brain insult (OR, 2.00; 95% CI, 1.02-4.00;  p  = 0.047); and no bystander-witnessed seizure onset (OR, 2.49; 95% CI, 1.05-5.59;  p  = 0.04).
","[{'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Fontaine', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Hopital Paris Saint Joseph, 185 Rue Raymond Losserand, 75014 Paris, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Lemiale', 'Affiliation': 'Medical Intensive Care Unit, Saint Louis University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Resche-Rigon', 'Affiliation': 'SBIM Biostatistics and Medical Information, Saint Louis University Hospital, APHP, 1 avenue Claude Vellefaux, Paris, France; Université Paris Diderot, Paris, France.'}, {'ForeName': 'Maleka', 'Initials': 'M', 'LastName': 'Schenck', 'Affiliation': 'Medical Intensive Care Unit, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Chelly', 'Affiliation': 'IctalGroup, Le Chesnay, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geeraerts', 'Affiliation': 'Anesthesiology and Critical Care Department, Toulouse University Hospital, University Toulouse 3 Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Aicha', 'Initials': 'A', 'LastName': 'Hamdi', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Centre Hospitalier de Montreuil, Montreuil, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Guitton', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Centre Hospitalier du Mans, Le Mans, France.'}, {'ForeName': 'Ferhat', 'Initials': 'F', 'LastName': 'Meziani', 'Affiliation': 'Medical Intensive Care Unit, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Intensive Care Units, Division of Anaesthesia, Intensive Care, Pain and Emergency Medicine, University Hospital of Nîmes, Nîmes, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Megarbane', 'Affiliation': 'Medical Intensive Care Unit, Lariboisiere University Hospital, APHP, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Mentec', 'Affiliation': 'Medical-Surgical Intensive Care Unit, Centre Hospitalier Victor Dupouy, Argenteuil, France.'}, {'ForeName': 'Cendrine', 'Initials': 'C', 'LastName': 'Chaffaut', 'Affiliation': 'SBIM Biostatistics and Medical Information, Saint Louis University Hospital, APHP, 1 avenue Claude Vellefaux, Paris, France; Université Paris Diderot, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Cariou', 'Affiliation': 'Medical Intensive Care Unit, Cochin University Hospital, Hopitaux Universitaires-Paris Centre, AP-HP, Paris, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Legriel', 'Affiliation': 'IctalGroup, Le Chesnay, France stlegriel@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010726']
2750,32913130,Effectiveness of providing university students with a mindfulness-based intervention to increase resilience to stress: 1-year follow-up of a pragmatic randomised controlled trial.,"BACKGROUND


There is concern that increasing demand for student mental health services reflects deteriorating student well-being. We designed a pragmatic, parallel, single-blinded randomised controlled trial hypothesising that providing mindfulness courses to university students would promote their resilience to stress up to a year later. Here we present 1-year follow-up outcomes.
METHODS


University of Cambridge students without severe mental illness or crisis were randomised (1:1, remote software-generated random numbers), to join an 8-week mindfulness course adapted for university students (Mindfulness Skills for Students (MSS)), or to mental health support as usual (SAU).
RESULTS


We randomised 616 students; 53% completed the 1-year follow-up questionnaire. Self-reported psychological distress and mental well-being improved in the MSS arm for up to 1 year compared to SAU (p<0.001). Effects were smaller than during the examination period. No significant differences between arms were detected in the use of University Counselling Service and other support resources, but there was a trend for MSS participants having milder needs. There were no differences in students' workload management; MSS participants made more donations. Home practice had positive dose-response effects; few participants meditated. No adverse effects related to self-harm, suicidality or harm to others were detected.
CONCLUSION


Loss to follow-up is a limitation, but evidence suggests beneficial effects on students' average psychological distress that last for at least a year. Effects are on average larger at stressful times, consistent with the hypothesis that this type of mindfulness training increases resilience to stress.
TRIAL REGISTRATION NUMBER


ACTRN12615001160527.",2020,Self-reported psychological distress and mental well-being improved in the MSS arm for up to 1 year compared to SAU (p<0.001).,"['University of Cambridge students without severe mental illness or crisis', '616 students; 53% completed the 1-year follow-up questionnaire', 'university students with a', 'university students']","['mindfulness-based intervention', 'remote software-generated random numbers), to join an 8-week mindfulness course adapted for university students (Mindfulness Skills for Students (MSS)), or to mental health support as usual (SAU']",['University Counselling Service'],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",616.0,0.239011,Self-reported psychological distress and mental well-being improved in the MSS arm for up to 1 year compared to SAU (p<0.001).,"[{'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Galante', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK mjg231@cam.ac.uk.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Stochl', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Dufour', 'Affiliation': 'University Counselling Service, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Maris', 'Initials': 'M', 'LastName': 'Vainre', 'Affiliation': 'MRC Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Adam Peter', 'Initials': 'AP', 'LastName': 'Wagner', 'Affiliation': 'National Institute for Health Research Applied Research Collaboration East of England, Cambridge, UK.'}, {'ForeName': 'Peter Brian', 'Initials': 'PB', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}]",Journal of epidemiology and community health,['10.1136/jech-2020-214390']
2751,32913154,Apical peri-prostatic nerve block versus intra-rectal xylocaine gel for trans- rectal ultrasound guided prostate biopsy among Nigerian patients: A prospective randomized study.,"Aims


This study compared the analgesic effect of apical peri-prostatic block with that of intra-rectal xylocaine gel for trans-rectal ultrasound guided prostate biopsy (TRUS-PBx) in Nigeria.
Methods


This is a prospective randomized comparative study carried out over one year in University of Benin Teaching Hospital, Edo State, Nigeria. The participants were randomized into two groups; Group A had 10 mls of intra-rectal xylocaine gel instillation while Group B had apical infiltration of 10 mls of 1% xylocaine all before TRUS-PBx.
Result


There was a statistically significant difference in the mean pain score during and one hour after TRUS-PBx between Group A and Group B of the study population respectively (p < 0.0001). Those that had intra-rectal xylocaine gel (Group A) had more pain during and after biopsy. There was no difference in the mean pain score during probe insertion between the two groups (p = 0.952).
Conclusion


This study demonstrated the superiority of apical peri-prostatic nerve block over intra rectal xylocaine gel instillation during TRUS-PBx with respect to its anesthetic efficacy. Therefore, centers providing TRUS-PBx in Nigeria should consider apical peri-prostatic nerve block as their mode of anesthesia for the procedure due to its efficacy and high safety profile.",2020,"There was no difference in the mean pain score during probe insertion between the two groups (p = 0.952).
","['Nigerian patients', 'trans-rectal ultrasound guided prostate biopsy (TRUS-PBx) in Nigeria', 'out over one year in University of Benin Teaching Hospital, Edo State, Nigeria']","['Group A had 10 mls of intra-rectal xylocaine gel instillation while Group B had apical infiltration of 10 mls of 1% xylocaine all before TRUS-PBx', 'intra-rectal xylocaine gel', 'Apical peri-prostatic nerve block versus intra-rectal xylocaine gel', 'rectal xylocaine gel', 'apical peri-prostatic nerve block over intra rectal xylocaine gel instillation']","['mean pain score', 'pain']","[{'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112240', 'cui_str': 'Rectal ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0574497', 'cui_str': 'Edo language'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0373345', 'cui_str': 'Transrectal ultrasound'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0441409,"There was no difference in the mean pain score during probe insertion between the two groups (p = 0.952).
","[{'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Ezenwa', 'Affiliation': 'Department of Surgery, Urology Unit, University of Benin Teaching Hospital, Benin City, Edo State, Nigeria.'}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Osaghae', 'Affiliation': 'Department of Surgery, Urology Unit, University of Benin Teaching Hospital; Department of Surgery, College of Medicine, University of Benin, Benin City, Edo State, Nigeria.'}, {'ForeName': 'E O', 'Initials': 'EO', 'LastName': 'Ozah', 'Affiliation': 'Department of Surgery, Urology Unit, University of Benin Teaching Hospital, Benin City, Edo State, Nigeria.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Okparanta', 'Affiliation': 'Department of Surgery, College of Medicine, University of Benin, Benin City, Edo State, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_219_19']
2752,32913166,"The effect of kinesio taping with the web strip technique on pain, edema, and trismus after impacted mandibular third molar surgery.","Backgound


There are many methods used to alleviate edema, trismus, and pain after impacted third molar (3M) removal, one of which is Kinesio Taping (KT).
Aims


This study aimed to evaluate the effectiveness of Kinesio Taping with Web Strip technique on postoperative morbidity after impacted mandibular 3M extraction.
Methods


The study employed a split-mouth and controlled randomized clinical trial design. A total of 60 patients were scheduled for surgical extractions of bilateral lower 3Ms. They were randomly divided into two groups, and KT was applied to one group while the others was determined as a control group without KT application. Tape was applied directly after surgery and maintained for postoperative (post-op) 7 days. Pain intensity was recorded subjectively using a Visual Analogue Scale (VAS). Pain and analgesic usage were recorded on the post-op 1 st , 2 nd , 3 rd , and 7 th  days. Trismus was evaluated before the surgery and on the post-op 2 nd  and 7 th  days. Facial edema was analyzed on the post-op 2 nd  and 7 th  days by VAS and by measuring the lengths of three lines using a flexible plastic tape measure.
Results


VAS pain scores were statistically lower in the KT group on the post-op 1 st , 3 rd  and 7 th  days. Total analgesic usage was also significantly lower in the KT group. On the post-op 2 nd  day, measurement of the lengths of three lines showed a statistically less edema in the KT group. Similar results were obtained from the measurement of edema using VAS. Maximum mouth opening was statistically higher in the KT group on the post-op 2 nd  and 7 th  day.
Conclusion


KT with the web strip technique should be considered more economic and less traumatic than other approaches, as it is free from systemic side effects and is a simple method to carry out to decrease morbidity.",2020,"Results


VAS pain scores were statistically lower in the KT group on the post-op 1 st , 3 rd  and 7 th  days.","['60 patients were scheduled for surgical extractions of bilateral lower 3Ms', 'after impacted mandibular third molar surgery']","['control group without KT application', 'kinesio taping with the web strip technique', 'Backgound', 'Kinesio Taping with Web Strip technique']","['edema', 'Maximum mouth opening', 'pain, edema, and trismus', 'Trismus', 'Total analgesic usage', 'Pain intensity', 'Visual Analogue Scale (VAS', 'VAS pain scores', 'Pain and analgesic usage', 'postoperative morbidity', 'Facial edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}]",60.0,0.0238633,"Results


VAS pain scores were statistically lower in the KT group on the post-op 1 st , 3 rd  and 7 th  days.","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Yurttutan', 'Affiliation': 'Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara, Turkey.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Sancak', 'Affiliation': 'Ankara Yildirim Beyazit University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, Ankara, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_23_20']
2753,32913173,Investigation of the esthetic outcomes of white spot lesion treatments.,"Objective


The present study compared the ability of bleaching, resin infiltration and microabrasion to restore the appearance of existing white spot lesions (WSL) on tooth surfaces as close as possible to that of the original healthy enamel.
Materials and Methods


Sixty extracted human teeth with WSL were randomly assigned to three treatment groups (20/group). Prior to treatment, the colour of the surrounding healthy enamel and the WSL were measured as the baseline and pre-treatment (PreRX) colours respectively using spectrophotometer based on CIE L*A*B. The L-value was used for the statistical comparison. WSLs in each group were treated respectively by bleaching, infiltration or microabrasion following the manufacturer's instructions. Colour measurement was repeated after treatment. Both intragroup and intergroup comparisons were performed using ANOVA followed by Tukey's multiple comparison test (α=0.05).
Result


In all groups the mean L-values were significantly higher in PreRX WSL (P < 0.01; Tukey) compared to baseline (sound enamel). After treatment the difference in mean L-value between baseline and WSL increased significantly (P < 0.01, Tukey) in Bleaching and Microabrasion groups by 1.4% and 1% respectively, but decreased in Infiltration group by 3.4%. Thus resin infiltration decreased the L-value of the WSL, bringing it closer to the L-value of the sound enamel while bleaching and microabrasion increased the L-value.
Conclusions


Among the three treatment modalities investigated in this study, resin infiltration was the most effective in masking the WSLs.",2020,In all groups the mean L-values were significantly higher in PreRX WSL (P < 0.01; Tukey) compared to baseline (sound enamel).,['Materials and Methods\n\n\nSixty extracted human teeth with WSL'],[],"['mean L-value', 'mean L-values']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0184942,In all groups the mean L-values were significantly higher in PreRX WSL (P < 0.01; Tukey) compared to baseline (sound enamel).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}, {'ForeName': 'L O', 'Initials': 'LO', 'LastName': 'Okoye', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, College of Medicine, University of Nigeria, Enugu, Nigeria.'}, {'ForeName': 'P P', 'Initials': 'PP', 'LastName': 'Lima', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Gakunga', 'Affiliation': 'Department of Developmental Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}, {'ForeName': 'B T', 'Initials': 'BT', 'LastName': 'Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, School of Dentistry, University of Texas Health San Antonio, Texas, USA.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_119_20']
2754,32913532,"Effects of aerobic and strength training on aerobic capacity, muscle strength, and gene expression of lymphomonocytes in patients with stable CAD.","This study examined the effectiveness, suitability, and safety of a mixed interval-type aerobic and strength training program (MIAST) on physical fitness in patients with stable coronary artery disease (CAD) without history of myocardial infarction (MI). Twenty-three patients with stable CAD were randomly assigned to a MIAST (n = 12; mean age 58.6 years) or control (n = 11; 63.3 years) group. The MIAST group participated in the progressive training program twice a week for 21 weeks. Peak oxygen uptake (VO 2peak ), workload, and exercise time were measured as were maximal muscle strength, serum lipids, glucose concentration, and the cross-sectional area (CSA) of knee extensors. The safety and suitability of the program were assessed by wireless electrocardiogram (ECG) monitoring and exercise diaries. VO 2peak  (6.9%; P < 0.05) and exercise time (11.2%; P < 0.05) improved significantly after 12 weeks of training in the MIAST group compared to the control group. Muscle strength (19.9%; P < 0.05) and CSA (2.2%; P < 0.05) increased, and serum lipids and blood glucose tended to decrease after the training. The successful training program (increase in maximal oxygen uptake) increased the gene expression of oxygen metabolism and decreased the gene expression of inflammation pathways in lymphomonocytes. The MIAST program, including interval-type aerobic and strength training, was safe, did not cause any adverse effects, and led to significant improvements in physical fitness in patients with stable CAD.",2020,"The MIAST program, including interval-type aerobic and strength training, was safe, did not cause any adverse effects, and led to significant improvements in physical fitness in patients with stable CAD.","['patients with stable CAD', 'patients with stable coronary artery disease (CAD) without history of myocardial infarction (MI', 'Twenty-three patients with stable CAD', 'n = 12; mean age 58.6 years) or control (n = 11; 63.3 years) group']","['mixed interval-type aerobic and strength training program (MIAST', 'aerobic and strength training', 'MIAST']","['CSA', 'gene expression of oxygen metabolism', 'exercise time', 'physical fitness', 'Peak oxygen uptake (VO 2peak ), workload, and exercise time', 'aerobic capacity, muscle strength, and gene expression of lymphomonocytes', 'maximal muscle strength, serum lipids, glucose concentration, and the cross-sectional area (CSA) of knee extensors', 'serum lipids and blood glucose', 'wireless electrocardiogram (ECG) monitoring and exercise diaries', 'Muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",23.0,0.0126728,"The MIAST program, including interval-type aerobic and strength training, was safe, did not cause any adverse effects, and led to significant improvements in physical fitness in patients with stable CAD.","[{'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Lehti', 'Affiliation': 'Faculty of Sport and Health Science, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Valkeinen', 'Affiliation': 'Finnish Institute for Health and Welfare Helsinki, Finland.'}, {'ForeName': 'Sarianna', 'Initials': 'S', 'LastName': 'Sipilä', 'Affiliation': 'Gerontology Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Merja', 'Initials': 'M', 'LastName': 'Perhonen', 'Affiliation': 'Suomen Terveystalo Oyj Jyväskylä, Finland.'}, {'ForeName': 'Mirva', 'Initials': 'M', 'LastName': 'Rottensteiner', 'Affiliation': 'Faculty of Sport and Health Science, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Pullinen', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Rauno', 'Initials': 'R', 'LastName': 'Pietiläinen', 'Affiliation': 'Lapland University of Applied Sciences Kemi, Finland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Nyman', 'Affiliation': 'Central Hospital of Central Finland Jyväskylä, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Vehkaoja', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University Tampere, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kainulainen', 'Affiliation': 'Neuromuscular Research Center, Faculty of Sport and Health Sciences, University of Jyväskylä Jyväskylä, Finland.'}, {'ForeName': 'Urho M', 'Initials': 'UM', 'LastName': 'Kujala', 'Affiliation': 'Faculty of Sport and Health Science, University of Jyväskylä Jyväskylä, Finland.'}]",American journal of translational research,[]
2755,32913533,"The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial.","This study aimed to evaluate the efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy. In this multicentered, blinded, randomized, active-controlled, non-inferior phase III trial, 384 eligible patients who were about to undergo colonoscopy were randomized as a ratio of 1:1 into remimazolam and propofol group. Procedure success was assessed and defined as the completion of colonoscopy without administration of rescue sedative agent or more than 5 top-ups of trial drug in any 15 minute-period after initial administration of trial drug. Sedation quality was evaluated by Modified Observer's Assessment of Alertness/Sedation score. Treatment-emergent adverse events were recorded. Procedure success rate was 96.91% (188/194) in remimazolam group and 100% (190/190) in propofol group, and the difference in rate was -3.09% with 95% confidence interval (CI) of -5.53%~-0.66%. Since the lower limit of 95% CI was greater than the non-inferiority margin of -8.00%, the efficacy of remimazolam tosylate was non-inferior to propofol. Besides, induction time of sedation was increased ( P <0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert ( P >0.05) or time to discharge ( P >0.05) were unchanged. For safety assessment, total treatment-emergent adverse events were decreased in remimazolam group compared to propofol group ( P <0.001); specifically, administration site pain ( P <0.001), increased bilirubin ( P =0.019), decreased respiratory rate ( P <0.001) and decreased SpO 2  ( P <0.001) were less frequent in remimazolam group compared with propofol group. In conclusion, remimazolam tosylate is non-inferior in sedation efficacy while safer than propofol in patients undergoing colonoscopy.",2020,"Besides, induction time of sedation was increased ( P <0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert ( P >0.05) or time to discharge ( P >0.05) were unchanged.","['patients undergoing colonoscopy', '384 eligible patients who were about to undergo colonoscopy']","['propofol', 'remimazolam tosylate versus propofol', 'remimazolam and propofol']","['respiratory rate', 'bilirubin', 'efficacy and safety', 'hypotension and respiratory depression', 'time to discharge', 'Procedure success', 'Sedation quality', 'safety assessment, total treatment-emergent adverse events', 'Alertness/Sedation score', 'administration site pain', 'induction time of sedation', 'Procedure success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C3874886', 'cui_str': 'Is about'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3179470', 'cui_str': 'remimazolam'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521491', 'cui_str': 'Application site pain'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",384.0,0.144003,"Besides, induction time of sedation was increased ( P <0.001), while hypotension and respiratory depression was decreased in remimazolam group compared to propofol group; however, time to fully alert ( P >0.05) or time to discharge ( P >0.05) were unchanged.","[{'ForeName': 'Shaohui', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.'}, {'ForeName': 'Shanfu', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University Beijing 100050, China.'}, {'ForeName': 'Anshi', 'Initials': 'A', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University Beijing 100020, China.'}, {'ForeName': 'Xiaoju', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Yijishan Hospital of Wannan Medical College Wuhu 241001, Anhui, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Xi'an Jiaotong University Xi'an 710061, Shanxi, China.""}, {'ForeName': 'Jianrui', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': ""Department of Anesthesiology, The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an 710004, Shanxi, China.""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Guangdong Provincial People's Hospital Guangzhou 510080, Guangdong, China.""}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou 510120, Guangdong, China.'}, {'ForeName': 'Yonghao', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, General Hospital of Tianjin Medical University Tianjin 300052, China.'}, {'ForeName': 'Dengbin', 'Initials': 'D', 'LastName': 'Ai', 'Affiliation': 'Department of Anesthesiology, Qingdao Municipal Hospital Qingdao 266011, Shandong, China.'}, {'ForeName': 'Ailin', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Tongji Medical College, Huazhong University of Sciences Technology Wuhan 430030, Hubei, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University Chongqing 400042, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, General Hospital of Shenyang Military Region, PLA Shenyang 110000, Liaoning, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University Guiyang 550000, Guizhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Peilin', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, Anhui Provincial Hospital Hefei 230001, Anhui, China.'}, {'ForeName': 'Xude', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Anesthesiology, Tangdu Hospital, Fourth Military Medical University Xi'an 710038, Shanxi, China.""}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Lianyungang Lianyungang 222061, Jiangsu, China.""}, {'ForeName': 'Jiaqiang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Henan Provincial People's Hospital Zhengzhou 450003, Henan, China.""}]",American journal of translational research,[]
2756,32913549,Alignment results of infrared computer-assisted navigation of total knee arthroplasty for end-stage knee osteoarthritis.,"OBJECTIVE


Total knee arthroplasty (TKA) is one of the most conventional surgeries used to solve dyskinesia caused by knee joint degeneration; however, ambiguous prosthesis position and angle after TKA can cause serious complications. This study evaluated the outcomes of infrared computer-assisted navigation (ICAN) of TKA for end-stage knee osteoarthritis.
METHODS


Forty-six end-stage knee osteoarthritis patients who underwent TKA were randomly divided into computer-assisted orthopedic surgery (CAOS) (n = 23) and non-CAOS (n = 23) groups. The intraoperative conditions, postoperative complications, soft tissue balancing, functional scores, and X-ray data were compared between groups.
RESULTS


The CAOS group showed longer surgery time and higher range of motion than the non-CAOS group. No significant differences in American Knee Society Score (AKSS) and Oxford Knee Score were observed between the two groups. Compared to those in the non-CAOS group, the error of the lower limb line, angle of soft tissue balancing, separation of soft tissue, and angular deviation (α, β, γ, δ) of the implants were much lower in the CAOS group.
CONCLUSION


The ICAN system for TKA surgery was associated with less intraoperative blood loss and suitable position and angle in patients with end-stage knee osteoarthritis.",2020,The ICAN system for TKA surgery was associated with less intraoperative blood loss and suitable position and angle in patients with end-stage knee osteoarthritis.,"['patients with end-stage knee osteoarthritis', 'Forty-six end-stage knee osteoarthritis patients who underwent TKA', 'total knee arthroplasty for end-stage knee osteoarthritis']","['infrared computer-assisted navigation', 'Total knee arthroplasty (TKA', 'infrared computer-assisted navigation (ICAN) of TKA', 'computer-assisted orthopedic surgery (CAOS) (n = 23) and non-CAOS']","['longer surgery time and higher range of motion', 'error of the lower limb line, angle of soft tissue balancing, separation of soft tissue, and angular deviation (α, β, γ, δ', 'intraoperative conditions, postoperative complications, soft tissue balancing, functional scores, and X-ray data', 'intraoperative blood loss and suitable position and angle', 'American Knee Society Score (AKSS) and Oxford Knee Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}]",,0.020452,The ICAN system for TKA surgery was associated with less intraoperative blood loss and suitable position and angle in patients with end-stage knee osteoarthritis.,"[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Guangxiang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Renjie', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Yuanshi', 'Initials': 'Y', 'LastName': 'She', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Xiangxin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Suzhou Municipal Hospital, The Affiliated Suzhou Hospital of Nanjing Medical University Suzhou 215000, Jiangsu, P. R. China.'}]",American journal of translational research,[]
2757,32913569,"Simulated root canals preparation time, comparing ProTaper Next and WaveOne Gold systems, performed by an undergraduate student.","Background


The aim of this study was to compare the WaveOne Gold and ProTaper Next systems regarding the time spent preparing simulated canals performed by an inexperienced student.
Material and Methods


0 simulated L-shaped canals were randomly divided into two groups (n = 40) and numbered in order of instrumentation. Canals were instrumented with WaveOne Gold (group 1) and ProTaper Next (group 2) systems. The effective instrumentation time and the number of instrumentation cycles were recorded. All procedures were performed by the same operator. Statistical analysis was obtained by the Mann - Whitney, Kruskal - Wallis test with significance of  p <0.05.
Results


There were no statistically significant differences regarding the mean instrumentation time between the two instrumentation systems. The instrumentation time decreased over the experimental period, regardless of the technique used.
Conclusions


Through a short learning curve, an inexperienced operator can prepare simulated canals in a very predictable time. Time spent was similar in a multi-file instrument system (ProTaper Next) and a single-file system (WaveOne Gold).  Key words: Dental education, endodontics, preclinical, root canal preparation, undergraduate.",2020,There were no statistically significant differences regarding the mean instrumentation time between the two instrumentation systems.,[],"['WaveOne Gold (group 1) and ProTaper Next', 'Material and Methods\n\n\n0 simulated L-shaped canals']","['mean instrumentation time', 'effective instrumentation time and the number of instrumentation cycles', 'instrumentation time', 'Time spent']",[],"[{'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",40.0,0.0288529,There were no statistically significant differences regarding the mean instrumentation time between the two instrumentation systems.,"[{'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Conceição', 'Affiliation': 'DMD, MDent, Faculty of Dental Medicine of University of Porto, Porto, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Ferreira', 'Affiliation': 'DMD, MDent, Faculty of Dental Medicine of University of Porto, Porto, Portugal.'}, {'ForeName': 'Ana-Cristina', 'Initials': 'AC', 'LastName': 'Braga', 'Affiliation': 'PhD, Department of Production and Systems, ALGORITMI Center, University of Minho, Portugal.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pina-Vaz', 'Affiliation': 'DMD, PhD, Faculty of Dental Medicine of University of Porto, Porto, Portugal.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56981']
2758,32913574,Fracture strength of endodontically treated lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite.,"Background


This study aimed to compare the fracture strength, fracture pattern and type of fracture of endodontically treated maxillary lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite.
Material and Methods


Eighty mature permanent maxillary lateral incisors from patients age range of 30-60 years with single canal were selected and randomly divided into: Group 1 - RCT + nanofilled composite (Filtek), Group 2 - RCT + microhybrid composite (Zmack), Group 3 - RCT + new nanohybrid composite (Zr-Hybrid) and Group 4 - Intact teeth (control). Standardized mesio-palatal-distal cavity was prepared, and endodontic treatment was carried out using crown-down technique until size 30, tapered 0.04. Obturation was completed using single cone technique with gutta-percha and AH plus sealer. Cavity access was restored with respective composite resins. Next, teeth were stored in incubator for 24 hours and subdivided into aged and unaged subgroups. Teeth in aged subgroups were subjected to 2500 thermal cycles for 5ºC, 37ºC and 55ºC with 30 seconds dwell time and 5 seconds transfer time. After that, root surfaces of teeth were covered with silicone-based material and placed in boxes filled with acrylic until the cemento-enamel-junction (CEJ) level. They were then tested under Universal Testing Machine until fracture occurred. Samples were then viewed under Leica microscope to determine the fracture pattern and type of fracture. Data analyzed using One-way ANOVA complimented by post hoc Tukey HSD and paired sample T test for fracture strength. Fracture pattern and type of fracture were analyzed using Chi-square test. Level of significance was set at  p <0.05.
Results


Significant differences were observed ( p <0.05) with Group 3 demonstrating the highest fracture strength followed by Group 4, Group 1 and lastly Group 2 in both aged and unaged subgroups respectively. A significant decreased in fracture strength was noted in Group 1 and Group 2 ( p <0.05) as number of thermocycle increased but no significant differences were noted in Group 3 and Group 4 ( p >0.05). Besides, Group 3 and Group 4 showed higher rate of favorable fracture pattern, followed by Group 1 and lastly Group 2. Most favorable fracture pattern was noted to exhibit horizontal fracture type (86.36%), whereas most unfavorable fracture pattern exhibited vertical fracture type (77.78%).
Conclusions


Endodontically treated teeth restored with new zirconia reinforced rice husk nanohybrid composite (Zr-Hybrid) demonstrated higher fracture strength than commercialized composite resins especially after artificial ageing. Zr-Hybrid showed similar fracture pattern to those of intact teeth with higher rate of horizontal fracture type.  Key words: Fracture strength, fracture pattern, composite resin, rice husk, Zirconia.",2020,"Results


Significant differences were observed ( p <0.05) with Group 3 demonstrating the highest fracture strength followed by Group 4, Group 1 and lastly Group 2 in both aged and unaged subgroups respectively.","['endodontically treated lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite', 'Eighty mature permanent maxillary lateral incisors from patients age range of 30-60 years with single canal', 'Teeth in aged subgroups', 'fracture of endodontically treated maxillary lateral incisors restored with new zirconia reinforced rice husk nanohybrid composite']","['RCT + nanofilled composite (Filtek), Group 2 - RCT + microhybrid composite (Zmack), Group 3 - RCT + new nanohybrid composite (Zr-Hybrid) and Group 4 - Intact teeth (control', 'single cone technique with gutta-percha and AH plus sealer']","['Cavity access', 'Fracture pattern and type of fracture', 'rate of favorable fracture pattern', 'number of thermocycle', 'highest fracture strength', 'Fracture strength', 'fracture strength']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}]",80.0,0.0265567,"Results


Significant differences were observed ( p <0.05) with Group 3 demonstrating the highest fracture strength followed by Group 4, Group 1 and lastly Group 2 in both aged and unaged subgroups respectively.","[{'ForeName': 'Galvin-Sim-Siang', 'Initials': 'GS', 'LastName': 'Lin', 'Affiliation': 'Conservative Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, Health campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Nik-Rozainah-Nik-Abdul', 'Initials': 'NR', 'LastName': 'Ghani', 'Affiliation': 'Conservative Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, Health campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Noor-Huda', 'Initials': 'NH', 'LastName': 'Ismail', 'Affiliation': 'Prosthodontic Unit, School of Dental Sciences, Universiti Sains Malaysia, Health Campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Singbal', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Mahsa University, Bandar Saujana Putra, 42610, Selangor, Malaysia.'}, {'ForeName': 'Devarasa-Giriyapura', 'Initials': 'DG', 'LastName': 'Murugeshappa', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Mahsa University, Bandar Saujana Putra, 42610, Selangor, Malaysia.'}, {'ForeName': 'Noraida', 'Initials': 'N', 'LastName': 'Mamat', 'Affiliation': 'Paediatric Dentistry Unit, School of Dental Sciences, Universiti Sains Malaysia, Health campus, 16150, Kubang Kerian, Kota Bharu, Kelantan, Malaysia.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56864']
2759,32658921,Systems-level barriers to treatment in a cervical cancer prevention program in Kenya: Several observational studies.,"OBJECTIVE


To identify health systems-level barriers to treatment for women who screened positive for high-risk human papillomavirus (hrHPV) in a cervical cancer prevention program in Kenya.
METHODS


In a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy. The current analysis draws on treatment data from this trial, as well as two observational studies that were conducted: 1) periodic assessments of the treatment sites to ascertain availability of resources for treatment and 2) surveys with treatment providers to elicit their views on barriers to care. Bivariate analyses were performed for the site assessment data, and the provider survey data were analyzed descriptively.
RESULTS


Seventeen site assessments were performed across three treatment sites. All three sites reported instances of supply stockouts, two sites reported treatment delays due to lack of supplies, and two sites reported treatment delays due to provider factors. Of the 16 providers surveyed, ten (67%) perceived lack of knowledge of HPV and cervical cancer as the main barrier in women's decision to get treated, and seven (47%) perceived financial barriers for transportation and childcare as the main barrier to accessing treatment. Eight (50%) endorsed that providing treatment free of cost was the greatest facilitator of treatment.
CONCLUSION


Patient education and financial support to reach treatment are potential areas for intervention to increase rates of hrHPV+ women presenting for treatment. It is also essential to eliminate barriers that prevent treatment of women who present, including ensuring adequate supplies and staff for treatment.",2020,"In a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy.","['women who screened positive for high-risk human papillomavirus (hrHPV) in a cervical cancer prevention program in Kenya', 'hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy', 'Kenya']",[],['lack of knowledge of HPV and cervical cancer'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",[],"[{'cui': 'C1998986', 'cui_str': 'Deficient knowledge'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",,0.0184468,"In a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy.","[{'ForeName': 'Charlotte M', 'Initials': 'CM', 'LastName': 'Page', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Saduma', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Park', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Huchko', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0235264']
2760,32913759,The effect of positive psychotherapy in test anxiety among Zahedan students with hemophilia.,"Hemophilia is a chronic disease which due to several reasons, including frequent absences from school and reduced motivation, leads to the incident of test anxiety among patients. This study was conducted with the aim of evaluating the effectiveness of positive psychotherapy in test anxiety among students with hemophilia. The current study followed a pretest, posttest, and two-month followup quasi-experimental design with an experimental group and a control group. This study had a statistical population including all senior elementary and junior high school students with hemophilia who had medical records in Zahedan Hemophilia Society. After screening them, 60 students were selected and randomly assigned to two 30-person groups of experimental and control. Since some patients refused to continue taking part in this study, the sample decreased to 57 people. Measurement tool used in this study was Sarason Test Anxiety Scale. Positive psychotherapy was held in 8 sessions (two 120-minute sessions per week) and a follow-up was conducted two months after completing the psychotherapy. Data were analyzed using a repeated measure analysis of variance. Results showed that positive psychotherapy significantly reduced test anxiety among the students with hemophilia. Moreover, the stability of the effects of this therapy in the follow-up was confirmed. The obtained results indicated that policymakers should pay a lot of attention to this new positive psychological training and its effects on reducing test anxiety.",2018,Results showed that positive psychotherapy significantly reduced test anxiety among the students with hemophilia.,"['Zahedan students with hemophilia', 'students with hemophilia', 'statistical population including all senior elementary and junior high school students with hemophilia who had medical records in Zahedan Hemophilia Society', '60 students']","['Positive psychotherapy', 'positive psychotherapy']","['Sarason Test Anxiety Scale', 'test anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0037455', 'cui_str': 'Societies'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0039577', 'cui_str': 'Test Anxiety Questionnaire'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",60.0,0.0146193,Results showed that positive psychotherapy significantly reduced test anxiety among the students with hemophilia.,"[{'ForeName': 'Mahbobe Ghavidel', 'Initials': 'MG', 'LastName': 'Heydari', 'Affiliation': 'Department of Psychology, Zahedan Branch, Islamic Azad University, Zahedan.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Shirazi', 'Affiliation': 'Department of Psychology, Faculty of Educational Sciences and Psychology, University of Sistan and Baluchestan, Zahedan, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Sanagouyemoharer', 'Affiliation': 'Department of Psychology, Zahedan Branch, Islamic Azad University, Zahedan.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2018.307']
2761,32913773,Metacognitive interpersonal therapy in group: a feasibility study.,"Patients with personality disorders (PDs) other than borderline, with prominent features of social inhibition and over-regulation of emotions, are in need of specialized treatments. Individuals present with poor metacognition, that is the capacity to understand mental states and use psychological knowledge for the sake of purposeful problem solving; and are guided by maladaptive interpersonal schemas. We developed a short-term group intervention, Metacognitive Interpersonal Therapy in Groups (MIT-G), incorporating psychoeducational and experiential elements, to help these individuals become more aware of their drives when interacting with others; and to help them adopt more flexible behaviors via improvements in metacognition. We present results of an effectiveness study, evaluating whether we could replicate the initial positive results of our first pilot randomized controlled trial. Seventeen young adults outpatients with personality disorders were included in the 16 session program. Effect sizes were calculated for change from baseline to treatment end for the primary outcome, symptoms and functioning (Clinical Outcomes in Routine Evaluation Outcome Measure) and then for one putative mechanism of change - metacognition. Emotional dysregulation and alexithymia were also assessed. Qualitative evaluations of the acceptability and subjective impact of the treatment were also performed. MIT-G was acceptable to participants. There were medium to large magnitude changes from pre- to post- treatment on wellbeing, emotion dysregulation, alexithymia and metacognition. These gains were maintained at follow-up. There was evidence of clinically significant change on key variables. MITG appears acceptable to patients, as evidenced by the absence of drop-out from treatment. In light of the positive outcomes of this study and the expanding evidence base, MIT-G is a candidate for dissemination and investigations in larger trials as a possible effective intervention for PDs characterized by tendencies to overcontrol.",2018,"There were medium to large magnitude changes from pre- to post- treatment on wellbeing, emotion dysregulation, alexithymia and metacognition.","['Seventeen young adults outpatients with personality disorders', 'Patients with personality disorders (PDs']","['Metacognitive interpersonal therapy', 'Metacognitive Interpersonal Therapy']","['wellbeing, emotion dysregulation, alexithymia and metacognition', 'Emotional dysregulation and alexithymia']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031212', 'cui_str': 'Personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}]",17.0,0.0709781,"There were medium to large magnitude changes from pre- to post- treatment on wellbeing, emotion dysregulation, alexithymia and metacognition.","[{'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Popolo', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'MacBeth', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Brunello', 'Affiliation': 'Servizio Psicologia Clinica DSM, AUSL Modena, Modena, Italy.'}, {'ForeName': 'Flaviano', 'Initials': 'F', 'LastName': 'Canfora', 'Affiliation': 'Servizio Adolescenti CEIS, Modena, Italy.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Ozdemir', 'Affiliation': 'University of Edinburgh, Edinburgh, Scotland, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rebecchi', 'Affiliation': 'Servizio Psicologia Clinica DSM, AUSL Modena, Modena, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Toselli', 'Affiliation': 'Villa Igea, Modena, Italy.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Venturelli', 'Affiliation': 'Servizio Psicologia Clinica DSM, AUSL Modena, Modena, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Salvatore', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Dimaggio', 'Affiliation': 'Centro di Terapia Metacognitiva Interpersonale, Rome, Italy.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2018.338']
2762,32913776,"Compassion-focused imagery reduces shame and is moderated by shame, self-reassurance and multisensory imagery vividness.","Compassion-focused imagery (CFI) is an emotion-regulation technique involving visualization of a person, animal or object offering one compassion, to generate feelings of safeness. It is proven to increase self-compassion and reduce negative affect. This study explores two hypotheses not previously investigated: i) which sensory modalities can stimulate compassionate affect; and ii) whether presentation of pictorial stimuli can enhance CFI. Additionally, we examine iii) whether CFI can reduce shame and iv) whether self-criticism inhibits CFI, since previous studies have involved small samples or methodological limitations. After completing measures of self-criticism, selfreassurance and imagery abilities in five sensory modalities, participants (n=160) were randomly assigned to look at compassionate images during CFI (visual input), compassionate images before CFI (priming), or abstract images (control). Participants trialled CFI then rated compassionate affect and completed open-response questions. Before and after CFI, participants recalled a shame-based memory and rated state shame. Correlational analyses explored whether self-criticism, self-reassurance, and multisensory imagery abilities moderated outcomes. CFI significantly reduced shame regarding a recalled memory, particularly for those high in shame. Compassionate affect was predicted by imagery vividness in visual and bodily-sensation modalities. Self-criticism predicted poorer CFI In multiple regressions, self-reassurance predicted poorer CFI outcomes but self-criticism did not. Between-group effects did not emerge. Qualitative data suggested that pictures helped some participants but hindered others. CFI is a promising technique for shame-prone clients, but may be challenging for those with low imagery abilities or unfamiliar with self-reassurance. Multiple senses should be engaged.",2019,"CFI significantly reduced shame regarding a recalled memory, particularly for those high in shame.","['five sensory modalities, participants (n=160']","['look at compassionate images during CFI (visual input), compassionate images before CFI (priming), or abstract images (control', 'CFI', 'Compassion-focused imagery (CFI']","['shame-based memory and rated state shame', 'imagery vividness in visual and bodily-sensation modalities', 'self-criticism, selfreassurance and imagery abilities']","[{'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0055288', 'cui_str': 'Chemotaxis factor inhibitor'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C1510633', 'cui_str': 'Self-Criticism'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",160.0,0.0254046,"CFI significantly reduced shame regarding a recalled memory, particularly for those high in shame.","[{'ForeName': 'Iona', 'Initials': 'I', 'LastName': 'Naismith', 'Affiliation': 'University of Los Andes, Colombia.'}, {'ForeName': 'Camilo Duran', 'Initials': 'CD', 'LastName': 'Ferro', 'Affiliation': 'University of Los Andes, Colombia.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ingram', 'Affiliation': 'University of Los Andes, Colombia.'}, {'ForeName': 'William Jimenez', 'Initials': 'WJ', 'LastName': 'Leal', 'Affiliation': 'University of Los Andes, Colombia.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.329']
2763,32913790,Is it possible to improve early childhood development with a video-feedback intervention directed at the mother-father-child triad?,"Relationships with primary caregivers provide the context for early childhood development, and evaluating those relationships during the early years can detect difficulties that may influence future mental health. Video feedback is a valuable intervention tool in early childhood, both for family relationships and child development. An intervention was implemented using this technique, focused on mother-father-child triads that were experiencing difficulties in social-emotional development. Participants were 80 mother-fatherinfant triads (experimental group, EG=40, control group, CG=40), with children between 1 and 3 years old. Socio-emotional difficulties decreased significantly in the children who received the intervention (Wilks λ=0.930, F (1, 78)=5.907; P=.017). There was also an increase in psychomotor development in communication (Wilks λ=0.948, F (1, 78) =4.284; P=.042) and fine motor skills (Wilks λ=0.875, F (1, 78)=11.185; P=.001) in children in the EG compared with children in the CG.",2019,"Socio-emotional difficulties decreased significantly in the children who received the intervention (Wilks λ=0.930, F (1, 78)=5.907; P=.017).","['Participants were 80 mother-fatherinfant triads (experimental group, EG=40, control group, CG=40), with children between 1 and 3 years old']",['Video feedback'],"['psychomotor development in communication', 'Socio-emotional difficulties', 'fine motor skills']","[{'cui': 'C0051533', 'cui_str': 'Am 80'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0076994', 'cui_str': 'Triad resin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0392358', 'cui_str': 'Psychomotor development'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",80.0,0.0163579,"Socio-emotional difficulties decreased significantly in the children who received the intervention (Wilks λ=0.930, F (1, 78)=5.907; P=.017).","[{'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Olhaberry', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'León', 'Affiliation': 'Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Sieverson', 'Affiliation': 'Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Escobar', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Iribarren', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Morales-Reyes', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Mena', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Leyton', 'Affiliation': 'School of Psychology, Pontifical Catholic University of Chile, Santiago.'}]",Research in psychotherapy (Milano),['10.4081/ripppo.2019.324']
2764,32371448,Transient hypoxemia induced by cortical electrical stimulation: A mapping study in 75 patients.,"OBJECTIVE


To identify which cortical regions are associated with direct electrical stimulation (DES)-induced alteration of breathing significant enough to impair pulse oximetry (SpO 2 ).
METHODS


Evolution of SpO 2  after 1,352 DES was analyzed in 75 patients with refractory focal epilepsy who underwent stereo-EEG recordings. For each DES, we assessed the change in SpO 2  from 30 seconds prior to DES onset to 120 seconds following the end of the DES. The primary outcome was occurrence of stimulation-induced transient hypoxemia as defined by decrease of SpO 2  ≥5% within 60 seconds after stimulation onset as compared to pre-DES SpO 2  or SpO 2  nadir <90% during at least 5 seconds. Localization of the stimulated contacts was defined according to MarsAtlas brain parcellation and Freesurfer segmentation.
RESULTS


A stimulation-induced transient hypoxemia was observed after 16 DES (1.2%) in 10 patients (13%), including 6 in whom SpO 2  nadir was <90%. Among these 16 DES, 7 (44%) were localized within the perisylvian cortex. After correction for individual effects and the varying number of DES contributed by each person, significant decrease of SpO 2  was significantly associated with the localization of DES ( p  = 0.019).
CONCLUSION


Though rare, a significant decrease of SpO 2  could be elicited by cortical direct electrical stimulation outside the temporo-limbic structures, most commonly after stimulation of the perisylvian cortex.",2020,"Though rare, a significant decrease of SpO 2  could be elicited by cortical direct electrical stimulation outside the temporo-limbic structures, most commonly after stimulation of the perisylvian cortex.","['75 patients with refractory focal epilepsy who underwent stereo-EEG recordings', '75 patients']",['cortical electrical stimulation'],"['transient hypoxemia', 'Transient hypoxemia', 'occurrence of stimulation-induced transient hypoxemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",75.0,0.113805,"Though rare, a significant decrease of SpO 2  could be elicited by cortical direct electrical stimulation outside the temporo-limbic structures, most commonly after stimulation of the perisylvian cortex.","[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Loizon', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ryvlin', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Chatard', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Bouet', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Guenot', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Mazzola', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bezin', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France.""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Rheims', 'Affiliation': ""From the Departments of Functional Neurology and Epileptology (M.L., J.J., S.R.) and Functional Neurosurgery (M.G.), Hospices Civils de Lyon and University of Lyon, France; Department of Clinical Neurosciences (P.R.), Centre Hospitalo-Universitaire Vaudois, Lausanne, Switzerland; INSERM U1028/CNRS UMR 5292 (B.C., J.J., R.B., M.G., L.M., L.B., S.R.), Lyon's Neuroscience Research Center; Neurology Department (L.M.), University Hospital, Saint-Etienne; and Epilepsy Institute (L.B., S.R.), Lyon, France. sylvain.rheims@chu-lyon.fr.""}]",Neurology,['10.1212/WNL.0000000000009497']
2765,32903044,Impact of Left Ventricular Function and Heart Failure Symptoms on Outcomes Post Ablation of Atrial Fibrillation in Heart Failure: CASTLE-AF Trial.,"Background  - Recent data demonstrates promising effects on left ventricular (LV) dysfunction and LV ejection fraction (EF) improvement following ablation for atrial fibrillation (AF) in patients with heart failure (HF). We sought to study the relationship between LVEF, NYHA class on presentation and the endpoints of mortality and HF admissions in the CASTLE-AF study population. Furthermore, predictors for LVEF improvement were examined.  Methods  - The CASTLE-AF patients with coexisting HF and AF (n=363) were randomized in a multicenter prospective controlled fashion to ablation (n=179) vs pharmacological therapy (n=184). LV function and NYHA class were assessed at baseline (after randomization) and at each follow-up visit.  Results  - In the ablation arm, a significantly higher number of patients experienced an improvement in their LVEF to >35% at the end of the study (OR=2.17; p<0.001). Compared to the pharmacological therapy arm, both ablation patient groups with severe (<20%) or moderate/severe (≥20% and <35%)) baseline LVEF had a significantly lower number of composite endpoints (hazard ratio (HR) =0.60; p=0.006), all-cause mortality (HR=0.54; p=0.019) and cardiovascular (CV) hospitalizations (HR=0.66; p=0.017). In the ablation group, NYHA I/II patients at the time of treatment had the strongest improvement in clinical outcomes (primary endpoint: HR=0.43; p<0.001; mortality: HR=0.30; p=0.001).  Conclusions  - Compared to pharmacological treatment, AF ablation was associated with a significant improvement in LVEF, independent from the severity of LV dysfunction. AF ablation should be performed at early stages of the patient's HF symptoms.",2020,"baseline LVEF had a significantly lower number of composite endpoints (hazard ratio (HR) =0.60; p=0.006), all-cause mortality (HR=0.54; p=0.019) and cardiovascular (CV) hospitalizations (HR=0.66; p=0.017).","['patients with heart failure (HF', 'Heart Failure', 'AF patients with coexisting HF and AF (n=363']","['pharmacological therapy', 'AF ablation']","['cause mortality', 'LVEF', 'cardiovascular (CV) hospitalizations', 'number of composite endpoints', 'LV function and NYHA class', 'mortality and HF admissions', 'left ventricular (LV) dysfunction and LV ejection fraction (EF) improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",363.0,0.0339413,"baseline LVEF had a significantly lower number of composite endpoints (hazard ratio (HR) =0.60; p=0.006), all-cause mortality (HR=0.54; p=0.019) and cardiovascular (CV) hospitalizations (HR=0.66; p=0.017).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sohns', 'Affiliation': 'Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Zintl', 'Affiliation': 'Department of Cardiology, Klinikum Coburg, Coburg, Germany.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Lilas', 'Initials': 'L', 'LastName': 'Dagher', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Andresen', 'Affiliation': 'Kardiologie an den Ev. Elisabeth-Kliniken, Berlin, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Siebels', 'Affiliation': 'Electrophysiology Center Bremen, Bremen, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Department of Medical Biometry & Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sehner', 'Affiliation': 'Department of Medical Biometry & Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Antonius Ziekenhuis Nieuwegein, Nieuwegein, the Netherlands.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Department of Cardiology, Semmelweis Medical University, Budapest, Hungary.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Pokushalov', 'Affiliation': 'State Research Institute of Circulation Pathology, Novosibirsk, Russia.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Centre for Heart Rhythm Disorders, University of Adelaide & Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Department of Cardiology, Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Bänsch', 'Affiliation': 'Clinic for Electrophysiology, KMG Klinikum, Güstrow, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mahnkopf', 'Affiliation': 'Department of Cardiology, Klinikum Coburg, Coburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Brachmann', 'Affiliation': 'Department of Cardiology, Klinikum Coburg, Coburg, Germany.'}, {'ForeName': 'Nassir F', 'Initials': 'NF', 'LastName': 'Marrouche', 'Affiliation': 'Department of Cardiology, Tulane University School of Medicine, New Orleans, LA.'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008461']
2766,32903062,Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial.,"BACKGROUND


Pharmacological management of migraine can be ineffective for some patients. We previously demonstrated that exposure to green light resulted in antinociception and reversal of thermal and mechanical hypersensitivity in rodent pain models. Given the safety of green light emitting diodes, we evaluated green light as a potential therapy in patients with episodic or chronic migraine.
MATERIAL AND METHODS


We recruited (29 total) patients, of whom seven had episodic migraine and 22 had chronic migraine. We used a one-way cross-over design consisting of exposure for 1-2 hours daily to white light emitting diodes for 10 weeks, followed by a 2-week washout period followed by exposure for 1-2 hours daily to green light emitting diodes for 10 weeks. Patients were allowed to continue current therapies and to initiate new treatments as directed by their physicians. Outcomes consisted of patient-reported surveys. The primary outcome measure was the number of headache days per month. Secondary outcome measures included patient-reported changes in the intensity and frequency of the headaches over a two-week period and other quality of life measures including ability to fall and stay asleep, and ability to perform work. Changes in pain medications were obtained to assess potential reduction.
RESULTS


When seven episodic migraine and 22 chronic migraine patients were analyzed as separate cohorts, white light emitting diodes produced no significant change in headache days in either episodic migraine or chronic migraine patients. Combining data from the episodic migraine and chronic migraine groups showed that white light emitting diodes produced a small, but statistically significant reduction in headache days from (days ± SEM) 18.2 ± 1.8 to 16.5 ± 2.01 days. Green light emitting diodes resulted in a significant decrease in headache days from 7.9 ± 1.6 to 2.4 ± 1.1 and from 22.3 ± 1.2 to 9.4 ± 1.6 in episodic migraine and chronic migraine patients, respectively. While some improvement in secondary outcomes was observed with white light emitting diodes, more secondary outcomes with significantly greater magnitude including assessments of quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version of the EuroQol five-dimensional survey without reported side effects were observed with green light emitting diodes. Conclusions regarding pain medications reduction with green light emitting diode exposure were not possible. No side effects of light therapy were reported. None of the patients in the study reported initiation of new therapies.
DISCUSSION


Green light emitting diodes significantly reduced the number of headache days in people with episodic migraine or chronic migraine. Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks. As no adverse events were reported, green light emitting diodes may provide a treatment option for those patients who prefer non-pharmacological therapies or may be considered in complementing other treatment strategies. Limitations of this study are the small number of patients evaluated. The positive data obtained support implementation of larger clinical trials to determine possible effects of green light emitting diode therapy.This study is registered with clinicaltrials.gov under NCT03677206.",2020,"Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks.","['We recruited (29 total) patients, of whom seven had episodic migraine and 22 had chronic migraine', 'people with episodic migraine or chronic migraine', 'migraine patients', '22 chronic migraine patients', 'patients with episodic or chronic migraine']","['green light exposure', 'green light emitting diode therapy']","['pain medications', 'quality of life and intensity and duration of the headache attacks', 'headache frequency and quality of life', 'headache days', 'number of headache days per month', 'number of headache days', 'patient-reported changes in the intensity and frequency of the headaches over a two-week period and other quality of life measures including ability to fall and stay asleep, and ability to perform work', 'quality of life, Short-Form McGill Pain Questionnaire, Headache Impact Test-6, and Five-level version']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C1306567', 'cui_str': 'Green light'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",,0.0526809,"Additionally, green light emitting diodes significantly improved multiple secondary outcome measures including quality of life and intensity and duration of the headache attacks.","[{'ForeName': 'Laurent F', 'Initials': 'LF', 'LastName': 'Martin', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Amol M', 'Initials': 'AM', 'LastName': 'Patwardhan', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Sejal V', 'Initials': 'SV', 'LastName': 'Jain', 'Affiliation': 'Department of Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Salloum', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Gannala', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Vasudha', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Felesia N', 'Initials': 'FN', 'LastName': 'Jones-MacFarland', 'Affiliation': 'Department of Neurology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'William Ds', 'Initials': 'WD', 'LastName': 'Killgore', 'Affiliation': 'Department of Psychiatry, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Porreca', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Mohab M', 'Initials': 'MM', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesiology, College of Medicine, University of Arizona, Tucson, AZ, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420956711']
2767,32903125,Simple trapeziectomy versus trapeziectomy with flexor carpi radialis suspension: a 17-year follow-up of a randomized blind trial.,"The purpose of this study was to investigate if there were any significant differences in the long-term outcomes of patients who participated in a randomized trial of trapeziectomy alone compared with trapeziectomy with ligament reconstruction and tendon interposition (LRTI). Sixty-five patients were invited for a follow-up visit at a mean of 17 years (range 15-20) postoperatively. Twenty-eight patients attended, who had 34 operations, 14 trapeziectomy alone and 20 with LRTI. There were no statistically significant differences between the two groups in terms of satisfaction with surgery or functional outcomes, with most measurements showing minimal or no differences in means between the two groups. There was no difference in the space between the metacarpal and scaphoid. Radial abduction was the only parameter that was significantly greater in the patients with simple trapeziectomy (median 79°) compared with trapeziectomy with LRTI (median 71°) ( p  = 0.04). Even at 17 years there is no significant benefit of LRTI over trapeziectomy alone for thumb carpometacarpal joint osteoarthritis. Level of evidence:  I.",2020,Even at 17 years there is no significant benefit of LRTI over trapeziectomy alone for thumb carpometacarpal joint osteoarthritis.,"['Twenty-eight patients attended, who had 34 operations, 14 trapeziectomy alone and 20 with LRTI', 'Sixty-five patients were invited for a follow-up visit at a mean of 17 years (range 15-20) postoperatively']","['trapeziectomy with ligament reconstruction and tendon interposition (LRTI', 'LRTI', 'trapeziectomy alone', 'Simple trapeziectomy versus trapeziectomy with flexor carpi radialis suspension']","['Radial abduction', 'satisfaction with surgery or functional outcomes']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0407613', 'cui_str': 'Excision of the trapezium'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0407613', 'cui_str': 'Excision of the trapezium'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",65.0,0.0611721,Even at 17 years there is no significant benefit of LRTI over trapeziectomy alone for thumb carpometacarpal joint osteoarthritis.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Brennan', 'Affiliation': 'Orthopaedic Department, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Blackburn', 'Affiliation': 'Orthopaedic Department, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Thomson', 'Affiliation': 'Orthopaedic Department, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Field', 'Affiliation': 'Orthopaedic Department, Cheltenham General Hospital, Cheltenham, UK.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420952966']
2768,32903262,Mediterranean diet and endothelial function in patients with coronary heart disease: An analysis of the CORDIOPREV randomized controlled trial.,"BACKGROUND


Endothelial dysfunction is a crucial step in atherosclerosis development, and its severity is determinant for the risk of cardiovascular recurrence. Diet may be an effective strategy to protect the endothelium, although there is no consensus about the best dietary model. The CORonary Diet Intervention with Olive oil and cardiovascular PREVention (CORDIOPREV) study is an ongoing prospective, randomized, single-blind, controlled trial in 1,002 coronary heart disease (CHD) patients, whose primary objective is to compare the effect of 2 healthy dietary patterns (low-fat versus Mediterranean diet) on the incidence of cardiovascular events. Here, we report the results of one secondary outcome of the CORDIOPREV study: to evaluate the effect of these diets on endothelial function, assessed by flow-mediated dilation (FMD) of the brachial artery.
METHODS AND FINDINGS


From the total participants taking part in the CORDIOPREV study, 805 completed endothelial function study at baseline and were randomized to follow a Mediterranean diet (35% fat, 22% monounsaturated fatty acids [MUFAs], and <50% carbohydrates) or a low-fat diet (28% fat, 12% MUFAs, and >55% carbohydrates), with endothelial function measurement repeated after 1 year. As secondary objectives and to explore different underlying mechanisms in the modulation of endothelial function, we quantified endothelial microparticles (EMPs) and endothelial progenitor cells (EPCs) and evaluated, in 24 preselected patients, in vitro cellular processes related to endothelial damage (reactive oxygen species, apoptosis, and senescence) and endothelial repair (cell proliferation and angiogenesis), as well as other modulators (micro-RNAs [miRNAs] and proteins). Patients who followed the Mediterranean diet had higher FMD (3.83%; 95% confidence interval [CI]: 2.91-4.23) compared with those in the low-fat diet (1.16%; 95% CI: 0.80 to 1.98) with a difference between diets of 2.63% (95% CI: 1.89-3.40, p = 0.011), even in those patients with severe endothelial dysfunction. We observed higher EPC levels (group difference: 1.64%; 95% CI: 0.79-2.13, p = 0.028) and lower EMPs (group difference: -755 EMPs/μl; 95% CI: -1,010 to -567, p = 0.015) after the Mediterranean diet compared with the low-fat diet in all patients. We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet. Each dietary intervention was associated with distinct changes in the epigenetic and proteomic factors that modulate biological process associated with endothelial dysfunction. The evaluation of endothelial function is a substudy of the CORDIOPREV study. As in any substudy, these results should be treated with caution, such as the potential for false positives because of the exploratory nature of the analyses.
CONCLUSIONS


Our results suggest that the Mediterranean diet better modulates endothelial function compared with a low-fat diet and is associated with a better balance of vascular homeostasis in CHD patients, even in those with severe endothelial dysfunction.
CLINICAL TRIAL REGISTRATION


URL, http://www.cordioprev.es/index.php/en. clinicaltrials.gov number NCT00924937.",2020,"We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet.","['From the total participants taking part in the CORDIOPREV study, 805 completed endothelial function study at baseline', '1,002 coronary heart disease (CHD) patients', '24 preselected patients', 'patients with coronary heart disease']","['Mediterranean diet and endothelial function', 'healthy dietary patterns (low-fat versus Mediterranean diet', 'CORonary Diet Intervention with Olive oil and cardiovascular PREVention', 'Mediterranean diet (35% fat, 22% monounsaturated fatty acids [MUFAs], and <50% carbohydrates) or a low-fat diet (28% fat, 12% MUFAs, and >55% carbohydrates', 'Mediterranean diet']","['cellular apoptosis', 'endothelial microparticles (EMPs) and endothelial progenitor cells (EPCs', 'vascular homeostasis', 'endothelial function, assessed by flow-mediated dilation (FMD) of the brachial artery', 'EPC levels', 'senescence', 'endothelial damage (reactive oxygen species, apoptosis, and senescence) and endothelial repair (cell proliferation and angiogenesis', 'endothelial function', 'higher cellular proliferation', 'intracellular reactive oxygen species (ROS) production', 'higher FMD']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}]","[{'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0596290', 'cui_str': 'Cellular Proliferation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}]",1002.0,0.154778,"We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet.","[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Yubero-Serrano', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Fernandez-Gandara', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Garcia-Rios', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Oriol A', 'Initials': 'OA', 'LastName': 'Rangel-Zuñiga', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Gutierrez-Mariscal', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Torres-Peña', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Marin', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Moreno', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Justo P', 'Initials': 'JP', 'LastName': 'Castaño', 'Affiliation': 'CIBER Physiopathology of Obesity and Nutrition (CIBEROBN), Institute of Health Carlos III, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Delgado-Lista', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Ordovas', 'Affiliation': 'Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University School of Medicine, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Perez-Martinez', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Miranda', 'Affiliation': 'Unidad de Gestión Clinica de Medicina Interna, Lipids and Atherosclerosis Unit, Maimonides Institute for Biomedical Research in Córdoba, Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.'}]",PLoS medicine,['10.1371/journal.pmed.1003282']
2769,32903263,"Mental fatigue impairs physical activity, technical and decision-making performance during small-sided games.","The aim of this study was to investigate the effects of mental fatigue on physical activity, technical and decision-making performance during small-sided games. Nine sub-elite soccer players were enrolled in the study. The players performed two small-sided games on two occasions within a crossover experimental design. Before each game, they underwent a mental fatiguing task (Stroop task) and a control task (documentary watching) in a randomized, counterbalanced order. Players' physical activity, technical, and decision-making performance were obtained during small-sided games by GPS and video scouting. Results showed that distance in acceleration covered per min, negative passes, passing accuracy, and shot accuracy were likely impaired than control task after a mental fatiguing protocol. Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task. These findings demonstrated that mental fatigue impacted on technical, GPS-derived, and soccer-specific decision-making performance during SSG. In conclusion, avoiding cognitively demanding tasks before playing soccer-specific activities may be advisable to preserve players' physical activity, technical, and decision-making skills.",2020,"Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task.",['Nine sub-elite soccer players'],['mental fatiguing task (Stroop task) and a control task (documentary watching'],"[""Players' physical activity, technical, and decision-making performance"", 'distance in acceleration covered per min, negative passes, passing accuracy, and shot accuracy', 'Mental fatigue impairs physical activity, technical and decision-making performance', 'physical activity, technical and decision-making performance']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0335694,"Decision-making performance of negative passes, passes accuracy, and dribbling accuracy resulted also likely decreased compared with control task.","[{'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Boccolini', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biotechnology and Life Sciences (DBSV), University of Insubria, Varese, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milano, Italy.'}]",PloS one,['10.1371/journal.pone.0238461']
2770,32903275,The potential effect of instrumentation with different nickel titanium rotary systems on dentinal crack formation-An in vitro study.,"The potential mechanical impact of different rotary systems used for root canal preparation has been a matter of debate for long. The aim of this study was to explore the incidence of dentinal cracks after root canal instrumentation with various rotary systems, in vitro. One hundred and eighty intact lower central incisors were selected and randomly divided into fourteen treatment groups (n = 12/group) and a control group (n = 12). After decoronation, the root canals were instrumented with fourteen different rotary systems (E3, E3 azure, NT2, Hyflex CM, Hyflex EDM, 2Shape, OneCurve, ProTaper Next, ProTaper Gold, WaveOne Gold, Mtwo, Reciproc Blue, TF adaptive, K3XF). All roots were horizontally sectioned at 3, 6, and 9 mm from the apex with a low-speed saw under water-cooling. The slices were then examined under stereomicroscope for dentinal cracks. No cracks were found in the control group. Cracks were found in all treatment groups, predominantly in the 3 mm slices. There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level. At 3 mm, however, five of the studied systems, namely K3XF (p = 0.004), Protaper Next (p = 0.001), Reciproc Blue (p<0.001), TF adaptive (p = 0.050), and 2Shape (p = 0.009) presented a significantly higher number of cracks than the control group. Within the limitations of this study, instrumented canals presented dentinal cracks, while uninstrumented ones presented no cracks after sectioning. There seems to be no significant difference among the tested systems regarding crack formation in the instrumented root canal wall. Crack formation occurred irrespective of the motion of the rotary system (rotational or reciprocation). Further studies are needed to clarify the factors that contribute to crack formation in the case of each individual rotary system.",2020,There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level.,['One hundred and eighty intact lower central incisors'],['nickel titanium rotary systems'],"['Reciproc Blue (p<0.001), TF adaptive', 'number of cracks', 'Crack formation', 'incidence of dentinal cracks']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0068790', 'cui_str': 'nitinol'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040441', 'cui_str': 'Fracture of tooth'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",180.0,0.0185325,There was no statistically significant difference in the number of cracks when comparing the different systems to each other at any section level.,"[{'ForeName': 'Márk', 'Initials': 'M', 'LastName': 'Fráter', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'András', 'Initials': 'A', 'LastName': 'Jakab', 'Affiliation': 'Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Braunitzer', 'Affiliation': 'dicomLAB Dental Ltd., Szeged, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Tóth', 'Affiliation': 'Department of Oral Biology and Experimental Dental Research, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Nagy', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, University of Szeged, Szeged, Hungary.'}]",PloS one,['10.1371/journal.pone.0238790']
2771,32903506,"Effects of an Innovative Telerehabilitation Intervention for People With Parkinson's Disease on Quality of Life, Motor, and Non-motor Abilities.","Parkinson's disease (PD) often leads to multifactorial motor and non-motor disabilities with resultant social restrictions. Continuity of care in this pathology, including a tailored home rehabilitation, is crucial to improve or maintain the quality of life for patients. The aim of this multicenter study was to test in a pilot sample of PD patients the efficiency and efficacy of the Human Empowerment Aging and Disability (HEAD) program. The virtual reality HEAD program was administered in two consecutive phases: (1) in clinic (ClinicHEAD, 12 45-minutes sessions, 3 sessions/week); (2) at home (HomeHEAD, 60 45-minutes sessions, 5 sessions/week). Thirty-one PD outpatients were enrolled [mean age (SD) = 66.84 (9.13)]. All patients performed ClinicHEAD, and after allocation (ratio 1:2) were assigned to the HomeHEAD or the Usual Care (UC) group. Motor, cognitive and behavioral outcome measures were assessed at enrollment (T0), at hospital discharge (T1), at 4 (T2) and 7 (T3) months after baseline. After ClinicHEAD (T1 vs. T0 comparison) a significant ( p  < 0.05) improvement in functional mobility, balance, upper limb mobility, global cognitive function, memory, quality of life and psychological well-being was observed. After the HomeHEAD intervention there was an additional enhancement for upper limb mobility. At T3 follow-up, the UC group that did not continue the HEAD program at home showed a worsening with respect to the HomeHEAD group in balance and functional mobility. Furthermore, in the HomeHEAD group, a positive association was observed between adherence, mental and physical health (SF-12). A trend was also registered between adherence and positive affect. The digital health patient-tailored rehabilitation program resulted in improving motor and non-motor abilities and quality of life in clinical setting, enhancing the motor function in telerehabilitation at home, and maintaining the non-motor abilities and quality of life at follow-up. In the near future, people with PD can be supported also at home with individualized rehabilitation strategies for a better quality of life and wellbeing along with lower costs for society.",2020,"The digital health patient-tailored rehabilitation program resulted in improving motor and non-motor abilities and quality of life in clinical setting, enhancing the motor function in telerehabilitation at home, and maintaining the non-motor abilities and quality of life at follow-up.","[""Parkinson's disease (PD"", ""People With Parkinson's"", 'Thirty-one PD outpatients were enrolled [mean age (SD) ']","['Innovative Telerehabilitation Intervention', 'Human Empowerment Aging and Disability (HEAD) program']","['improving motor and non-motor abilities and quality of life', 'Quality of Life, Motor, and Non-motor Abilities', 'functional mobility, balance, upper limb mobility, global cognitive function, memory, quality of life and psychological well-being', 'Motor, cognitive and behavioral outcome measures', 'adherence, mental and physical health (SF-12', 'upper limb mobility']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0252138,"The digital health patient-tailored rehabilitation program resulted in improving motor and non-motor abilities and quality of life in clinical setting, enhancing the motor function in telerehabilitation at home, and maintaining the non-motor abilities and quality of life at follow-up.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Isernia', 'Affiliation': 'IRCCS Fondazione don Carlo Gnocchi ONLUS, Milan, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Di Tella', 'Affiliation': 'IRCCS Fondazione don Carlo Gnocchi ONLUS, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pagliari', 'Affiliation': 'IRCCS Fondazione don Carlo Gnocchi ONLUS, Milan, Italy.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Jonsdottir', 'Affiliation': 'IRCCS Fondazione don Carlo Gnocchi ONLUS, Milan, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Castiglioni', 'Affiliation': 'Fondazione Opera San Camillo Presidio Sanitario San Camillo, Turin, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Gindri', 'Affiliation': 'Fondazione Opera San Camillo Presidio Sanitario San Camillo, Turin, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Salza', 'Affiliation': 'Fondazione Opera San Camillo Presidio Sanitario San Camillo, Turin, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gramigna', 'Affiliation': 'Villa Beretta Rehabilitation Center, Costa Masnaga, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Palumbo', 'Affiliation': 'Villa Beretta Rehabilitation Center, Costa Masnaga, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Molteni', 'Affiliation': 'Villa Beretta Rehabilitation Center, Costa Masnaga, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Baglio', 'Affiliation': 'IRCCS Fondazione don Carlo Gnocchi ONLUS, Milan, Italy.'}]",Frontiers in neurology,['10.3389/fneur.2020.00846']
2772,32903623,Personalized Medicine for PLA2R1-Related Membranous Nephropathy: A Multicenter Randomized Control Trial.,"Background:  Membranous Nephropathy (MN) is a rare autoimmune disease related to PLA2R1 antibodies in 70% of cases. One third of patients enter in spontaneous remission. PLA2R1 epitopes in MN have been characterized in four different domains of PLA2R1 and a mechanism of epitope spreading from the immunodominant CysR domain to CTLD1 and/or CTLD7 and/or CTLD8 domains has been associated with poor prognosis. Epitope spreading could predict spontaneous remission (45% in non-spreader patients vs. 0.05% in spreader patients). The comparison of different regimens of rituximab dosing showed that: (i) early remission rate depends on rituximab dosing, (ii) low dose could be enough for patients with anti-PLA2R1 activity restricted to CysR, (iii) high dose may be required for spreader patients. This study aims to evaluate the efficacy of personalized treatment in PLA2R1-related MN depending on the epitope spreading status, in comparison to the established GEMRITUX protocol.  Methods:  A multicenter, randomized, controlled, prospective clinical trial will be conducted in 22 French hospitals. Sixty-four consecutive patients with PLA2R1-related MN will be randomly assigned to either the control group following the GEMRITUX protocol (symptomatic treatment for 6 months, if the nephrotic syndrome (NS) persists at month-6, two 375 mg/m 2  rituximab infusions at 1 week interval) or the personalized treatment group (patients with no epitope spreading at month-0 will be treated with symptomatic treatment for 6 months, if NS persists at month-6, two 375 mg/m 2  rituximab infusions at 1 week interval; patients with epitope spreading at month-0 or month-6 with persistent NS will be treated immediately with two 1 g rituximab infusions at 2 week interval). The primary study outcome is the rate of clinical remission at month-12. The secondary outcomes include complete and partial remissions, immunological remissions, relapses, proteinuria, albuminuria, serum creatinine, eGFR, PLA2R1 antibody titers, severe infections, lymphocyte counts and lymphocyte phenotype, residual rituximab levels at month-3 and neutralizing anti-rituximab antibodies at month-6 and month-12 after rituximab treatment.  Discussion:  The results of this trial will confirm whether personalized treatment of PLA2R1-driven nephrotic MN is more efficient to induce clinical remission than the established GEMRITUX protocol, and may thus contribute to improved remission rates and reduced relapse rates.  Trial registration:  NCT03804359 trial number. Registered on 15th January 2019.",2020,Epitope spreading could predict spontaneous remission (45% in non-spreader patients vs. 0.05% in spreader patients).,"['Sixty-four consecutive patients with PLA2R1-related MN', 'PLA2R1-Related Membranous Nephropathy', '22 French hospitals']","['CTLD7', 'rituximab', 'Personalized Medicine', 'control group following the GEMRITUX protocol (symptomatic treatment', 'CTLD1', 'personalized treatment group (patients with no epitope spreading at month-0 will be treated with symptomatic treatment']","['remission rate', 'rate of clinical remission', 'complete and partial remissions, immunological remissions, relapses, proteinuria, albuminuria, serum creatinine, eGFR, PLA2R1 antibody titers, severe infections, lymphocyte counts and lymphocyte phenotype, residual rituximab levels at month-3 and neutralizing anti-rituximab antibodies', 'spontaneous remission']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003316', 'cui_str': 'Epitope'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0035053', 'cui_str': 'Remission, Spontaneous'}]",64.0,0.0945953,Epitope spreading could predict spontaneous remission (45% in non-spreader patients vs. 0.05% in spreader patients).,"[{'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Brglez', 'Affiliation': ""Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Boyer-Suavet', 'Affiliation': ""Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Zorzi', 'Affiliation': ""Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': ""Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Département de Recherche Clinique et Innovation, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Esnault', 'Affiliation': ""Unité de Recherche Clinique de la Côte d'Azur (UR2CA), Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Seitz-Polski', 'Affiliation': ""Centre de Référence Maladies Rares Syndrome Néphrotique Idiopathique, Centre Hospitalier Universitaire de Nice, Université Côte d'Azur, Nice, France.""}]",Frontiers in medicine,['10.3389/fmed.2020.00412']
2773,32903687,Mindfulness-Based Restoration Skills Training (ReST) in a Natural Setting Compared to Conventional Mindfulness Training: Psychological Functioning After a Five-Week Course.,"Restoration skills training (ReST) is a mindfulness-based course that draws on restorative nature experience to facilitate the meditation practice and teach widely applicable adaptation skills. Previous studies comparing ReST to conventional mindfulness training (CMT) showed that ReST has important advantages: it supports beginning meditators in connecting with restorative environmental qualities and in meditating with less effort; it restores their attention regulation capabilities; and it helps them complete the course and establish a regular meditation habit. However, mindfulness theory indicates that effortful training may be necessary to achieve generalized improvements in psychological functioning. Therefore, this study tests whether the less effortful and more acceptable ReST approach is attended by any meaningful disadvantage compared to CMT in terms of its effects on central aspects psychological functioning. We analyze data from four rounds of development of the ReST course, in each of which we compared it to a parallel and formally matched CMT course. Randomly assigned participants (total course starters = 152) provided ratings of dispositional mindfulness, cognitive functioning, and chronic stress before and after the 5-week ReST and CMT courses. Round 4 also included a separately recruited passive control condition. ReST and CMT were attended by similar average improvements in the three outcomes, although the effects on chronic stress were inconsistent. Moderate to large improvements in the three outcomes could also be affirmed in contrasts with the passive controls. Using a reliable change index, we saw that over one third of the ReST and CMT participants enjoyed reliably improved psychological functioning. The risk of experiencing deteriorated functioning was no greater with either ReST or CMT than for passive control group participants. None of the contrasts exceeded our stringent criterion for inferiority of ReST compared with CMT. We conclude that ReST is a promising alternative for otherwise healthy people with stress or concentration problems who would be less likely to complete more effortful CMT. By adapting the meditation practices to draw on restorative setting characteristics, ReST can mitigate the demands otherwise incurred in early stages of mindfulness training without compromising the acquisition of widely applicable mindfulness skills.",2020,"ReST and CMT were attended by similar average improvements in the three outcomes, although the effects on chronic stress were inconsistent.",[],"['Mindfulness-Based Restoration Skills Training (ReST', 'Restoration skills training (ReST', 'ReST or CMT', 'Conventional Mindfulness Training', 'ReST', 'ReST to conventional mindfulness training (CMT']","['ratings of dispositional mindfulness, cognitive functioning, and chronic stress', 'psychological functioning', 'chronic stress', 'Psychological Functioning']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.0243359,"ReST and CMT were attended by similar average improvements in the three outcomes, although the effects on chronic stress were inconsistent.","[{'ForeName': 'Freddie', 'Initials': 'F', 'LastName': 'Lymeus', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Ahrling', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Apelman', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Cecilia de Mander', 'Initials': 'CM', 'LastName': 'Florin', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Nilsson', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Vincenti', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Zetterberg', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Lindberg', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Hartig', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01560']
2774,32903747,"Hydrolyzed Protein Formula for Allergy Prevention in Preterm Infants: Follow-Up Analysis of a Randomized, Triple-Blind, Placebo-Controlled Study.","Background:  Allergic diseases are a major public health burden worldwide. Evidence suggests that early nutrition might play a key role in the future development of allergies and the use of hydrolyzed protein formulas have been proposed to prevent allergic disease, mainly in term infants with risk factors.  Aim:  To evaluate the preventive effect of a hydrolyzed protein formula vs. an intact protein formula on allergy development in preterm infants with or without risk factors.  Methods:  We performed a 3-year follow-up study of a previous triple-blind, placebo-controlled randomized trial. Evidence of atopic dermatitis, asthma and IgE-mediated food allergies were evaluated according to a validated parental questionnaire (Comprehensive Early Childhood Allergy Questionnaire). Food sensitization was also investigated by skin prick test at 3 years of chronological age.  Results:  Of the 30 subjects in the intact protein formula group and 30 in the extensively hydrolyzed formula group, respectively 18 and 16 completed the 3-year follow-up and entered the final analysis. No group differences in the incidence of atopic dermatitis, asthma, IgE-mediated food allergies, and food sensitization were found.  Conclusion:  Despite the small number of cases, extensively hydrolyzed protein formula seems to be ineffective in allergic diseases prevention in preterm neonates. Further adequately powered, randomized controlled trials evaluating hydrolyzed protein formula administration to prevent allergic diseases in preterm neonates are needed.",2020,"No group differences in the incidence of atopic dermatitis, asthma, IgE-mediated food allergies, and food sensitization were found.  ","['30 subjects in the intact protein formula group and 30 in the extensively hydrolyzed formula group, respectively 18 and 16 completed the 3-year follow-up and entered the final analysis', 'preterm infants with or without risk factors', 'preterm neonates', 'Preterm Infants']","['hydrolyzed protein formula vs. an intact protein formula', 'placebo', 'hydrolyzed protein formula administration', 'Hydrolyzed Protein Formula', 'Placebo']","['Food sensitization', 'incidence of atopic dermatitis, asthma, IgE-mediated food allergies, and food sensitization']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}]","[{'cui': 'C3853229', 'cui_str': 'Hydrolyzed protein formula'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0016470', 'cui_str': 'Allergy to food'}]",30.0,0.137382,"No group differences in the incidence of atopic dermatitis, asthma, IgE-mediated food allergies, and food sensitization were found.  ","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Mauro', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Maria Elisabetta', 'Initials': 'ME', 'LastName': 'Baldassarre', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Brindisi', 'Affiliation': 'Pediatrics Department, Umberto I Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Zicari', 'Affiliation': 'Pediatrics Department, Umberto I Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Tarantini', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Nicla', 'Initials': 'N', 'LastName': 'Laera', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Capozza', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Panza', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Salvatore', 'Affiliation': 'Department of Pediatric, Ospedale ""F. Del Ponte"", University of Insubria, Varese, Italy.'}, {'ForeName': 'Licia', 'Initials': 'L', 'LastName': 'Pensabene', 'Affiliation': 'Pediatric Unit, Department of Medical and Surgical Sciences, University ""Magna Graecia"" of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Fanelli', 'Affiliation': 'Department of Interdisciplinary Medicine, ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Laforgia', 'Affiliation': 'Section of Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, ""Aldo Moro"" University of Bari, Bari, Italy.'}]",Frontiers in pediatrics,['10.3389/fped.2020.00422']
2775,32918266,"Comparative efficacy of permethrin 1%, lindane 1%, and dimeticone 4% for the treatment of head louse infestation in Iran.","Pediculosis capitis occurs worldwide. Children in the age group of 5-13 years are the ordinary victims. Population-based studies show that the prevalence of pediculosis is 1.6-13.4% in various regions of Iran. In this observer-blinded trial, we conducted a study to evaluate the comparative efficacy and safety of permethrin 1% and lindane 1% shampoos and dimeticone 4% lotion to cure head lice infestation in children aged 7-13 years in female primary schools in Ahvaz City, Iran. Children with head lice were randomized to receive each treatment. Two applications of permethrin 1% or dimeticone 4% were done, 1 week apart. However, lindane 1% was used just once for treatment cases. Data analysis was done using SPSS software. Recovery differences between the groups were tested using the chi-squared test. Four hundred forty-four louse-infested schoolgirls were randomly treated with them. Permethrin, lindane, dimeticone, and placebo produced the recovery rates 56.8, 31.5, 51.4, and 10.8% on day 2 post-treatment, respectively. Cure rates were in the permethrin group on days 8 and 15, respectively, 69.4 and 90.1%. The success rates were in the lindane group on days 8 and 15, respectively, 73 and 86.5%. The success rates were in the dimeticone group on days 8 and 15, respectively, 60.4 and 94.6%. It is recommended dimeticone lotion (4%) as a very effective and safe pediculicide for pediculosis control. With proper application, dimethicone can rapidly cure head lice infestation with minimal reinfestation.",2020,"The success rates were in the lindane group on days 8 and 15, respectively, 73 and 86.5%.","['Four hundred forty-four louse-infested schoolgirls', 'children aged 7-13\xa0years in female primary schools in Ahvaz City, Iran', 'head louse infestation in Iran', 'Children in the age group of 5-13\xa0years are the ordinary victims', 'Children with head lice']","['dimethicone', 'permethrin 1% and lindane 1% shampoos and dimeticone 4% lotion', 'permethrin', 'dimeticone lotion']","['Cure rates', 'recovery rates', 'success rates', 'comparative efficacy and safety']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0003121', 'cui_str': 'Order Anoplura'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030757', 'cui_str': 'Pediculosis capitis'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C0721771', 'cui_str': 'Moisturel'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0689366', 'cui_str': 'Lindane 10 MG/ML Medicated Shampoo'}, {'cui': 'C1113707', 'cui_str': 'dimethicone'}, {'cui': 'C0544341', 'cui_str': 'Lotion'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0240987,"The success rates were in the lindane group on days 8 and 15, respectively, 73 and 86.5%.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Kassiri', 'Affiliation': 'Department of Medical Entomology, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Hamid.Kassiri@yahoo.com.'}, {'ForeName': 'Atefe Ebrahimi', 'Initials': 'AE', 'LastName': 'Fahdani', 'Affiliation': 'Department of Medical Entomology, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Cheraghian', 'Affiliation': 'Department of Bio-Statistics, School of Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Environmental science and pollution research international,['10.1007/s11356-020-10686-3']
2776,32918272,Circulating Fibroblast Growth Factor-21 and Risk of Metachronous Colorectal Adenoma.,"PURPOSE


Prior work has shown that higher circulating concentrations of fibroblast growth factor-21 (FGF-21) are associated with an increased likelihood of developing colorectal cancer. We conducted a prospective study to assess the relationship between circulating FGF-21 and odds of developing early neoplastic lesions in the colorectum.
METHODS


A total of 94 study participants were included from the ursodeoxycholic acid (UDCA) trial, a phase III, randomized, double-blind, placebo-controlled clinical trial of the effect of 8-10 mg/kg of body weight UDCA vs. placebo. Logistic regression analyses were conducted to evaluate the association between baseline FGF-21 concentrations and odds of developing a metachronous adenoma.
RESULTS


Of the characteristics compared across tertiles of FGF-21 concentrations, including age, race, sex, BMI, and other variables, only a previous personal history of colorectal polyps prior to entry into the UDCA trial was statistically significantly related to FGF-21 levels, with a proportion of 26.7%, 56.7%, and 50.0% across the first, second, and third tertiles, respectively (p < 0.05). Higher circulating concentrations of FGF-21 were statistically significantly associated with greater odds of developing a metachronous colorectal adenoma. After adjusting for potential confounders and when compared with the lowest tertile of FGF-21, the adjusted ORs (95% CIs) for metachronous colorectal adenoma in the second and third tertiles were 4.72 (95% CI, 1.42-15.72) and 3.82 (95% CI, 1.15-12.68), respectively (p trend < 0.05).
CONCLUSION


Our results reveal for the first time that, in addition to a recently discovered association with colorectal cancer, circulating FGF-21 concentrations are significantly and directly associated with odds of developing metachronous colorectal adenoma.",2020,Higher circulating concentrations of FGF-21 were statistically significantly associated with greater odds of developing a metachronous colorectal adenoma.,['A total of 94 study participants were included from the'],"['placebo', 'body weight UDCA vs. placebo', 'ursodeoxycholic acid (UDCA']","['FGF-21 levels', 'metachronous colorectal adenoma', 'Higher circulating concentrations of FGF-21']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",94.0,0.0634546,Higher circulating concentrations of FGF-21 were statistically significantly associated with greater odds of developing a metachronous colorectal adenoma.,"[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Florea', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA. aflorea@arizona.edu.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Yann C', 'Initials': 'YC', 'LastName': 'Klimentidis', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Lindsay N', 'Initials': 'LN', 'LastName': 'Kohler', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Jurutka', 'Affiliation': 'School of Mathematical and Natural Sciences, Arizona State University, Glendale, AZ, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Jacobs', 'Affiliation': 'Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, USA.'}]",Journal of gastrointestinal cancer,['10.1007/s12029-020-00515-8']
2777,32918306,Shear-Wave Elastography-Guided Core Needle Biopsy for the Determination of Breast Cancer Molecular Subtype.,"OBJECTIVE


To investigate whether shear-wave elastography (SWE) guidance during core-needle biopsy can improve diagnostic accuracy and accurate determination of the molecular subtypes of breast cancer.
METHODS


This controlled, randomized prospective cohort study included 58 patients (mean age: 56.9 ± 16.2) who were referred for image-guided core-needle biopsy between May 2018 and April 2019 for lesions larger than 1 cm. In Group 1, 30 lesions were biopsied without SWE guidance and recorded as Biopsy A. In Group 2, 30 lesions were examined with SWE before biopsy, and then two different parts of the lesions were biopsied; biopsies from the relatively rigid areas of the lesions were recorded as Biopsy B, and biopsies from the less rigid areas of the lesions were recorded as Biopsy C. The histopathological and immunohistochemical results of biopsies were compared with the surgical results.
RESULTS


The sensitivity of Biopsy A, B and C were 96.7%, 100% and 100%, respectively. The benign-malignant concordance rates were 94.7%, 100%, and 90% and the diagnostic concordance rates were 89.5%, 100%, and 90% in Biopsies A, B, and C, respectively. When the 10% differences in the estrogen receptor (ER), progesterone receptor (PR), and Ki67 rates were considered significant, the concordance rate of ER was highest in Biopsy B (77.8%; p = 0.040). The concordance rate of immunohistochemical subtyping was 100% in Biopsy B and 71.4% in Biopsies A and C (p = 0.086).
CONCLUSION


SWE-guided core-needle biopsy of breast lesions increased the sensitivity, diagnostic accuracy, and accuracy of immunohistochemical subtyping to 100%.",2020,"The concordance rate of immunohistochemical subtyping was 100% in Biopsy B and 71.4% in Biopsies A and C (p = 0.086).
",['58 patients (mean age: 56.9\u2009±\u200916.2) who were referred for image-guided core-needle biopsy between May 2018 and April 2019 for lesions larger than 1\u2009cm'],"['Shear-Wave Elastography-Guided Core Needle Biopsy', 'shear-wave elastography (SWE) guidance']","['estrogen receptor (ER), progesterone receptor (PR), and Ki67 rates', 'concordance rate of ER', 'sensitivity of Biopsy A, B and C', 'benign-malignant concordance rates', 'diagnostic concordance rates', 'sensitivity, diagnostic accuracy, and accuracy of immunohistochemical subtyping', 'concordance rate of immunohistochemical subtyping']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319690', 'cui_str': '16.2'}, {'cui': 'C0420567', 'cui_str': 'Refer for imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",58.0,0.0250987,"The concordance rate of immunohistochemical subtyping was 100% in Biopsy B and 71.4% in Biopsies A and C (p = 0.086).
","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Peker', 'Affiliation': 'Department of Radiology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Pınar', 'Initials': 'P', 'LastName': 'Balci', 'Affiliation': 'Department of Radiology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Isil', 'Initials': 'I', 'LastName': 'Basara Akin', 'Affiliation': 'Department of Radiology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Hakan A', 'Initials': 'HA', 'LastName': 'Özgül', 'Affiliation': 'Department of Radiology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Süleyman Ö', 'Initials': 'SÖ', 'LastName': 'Aksoy', 'Affiliation': 'Department of Genereal Surgery, Dokuz Eylul University, Faculty of Medicine, Izmir, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Gürel', 'Affiliation': 'Department of Pathology, Dokuz Eylul University, Faculty of Medicine, Izmir, Turkey.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15499']
2778,32918323,Blinding and bias in a hypnotic clinical trial.,"OBJECTIVES


Information is lacking regarding how commonly unblinding of treatment assignment occurs in hypnotic randomized clinic trials (RCTs). We now report the ""best guesses"" of clinical trial participants, versus study coordinators, versus study physicians in the study Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT).
METHODS


REST-IT, a, 8-week double-blind RCT, compared zolpidem extended-release (ER) versus placebo at bedtime in 103 adults with major depressive disorder with insomnia and suicidal ideation, and who received open label selective serotonin reuptake inhibitors. At the conclusion of study participation, 89 of the participants in this study, the study coordinators, and the study physicians each independently recorded their ""best guess"" of the treatment assigned.
RESULTS


Patients guessed correctly 58.4% of the time, coordinators 53.9% of the time, and physicians 49.4% of the time, and none were different from chance alone. Agreement between patient/coordinator, patient/doctor, and coordinator/doctor dyads were 75%-78% with no significant differences in agreement between the dyads.
CONCLUSIONS


""Best guesses"" of all parties were not different from chance, suggesting that the blind was maintained and that assessment bias was minimized in this RCT of zolpidem ER versus placebo. Our results may not apply to other hypnotics or other RCT designs.",2020,"RESULTS


Patients guessed correctly 58.4% of the time, coordinators 53.9% of the time, and physicians 49.4% of the time, and none were different from chance alone.","['103 adults with major depressive disorder with insomnia and suicidal ideation, and who received open label selective serotonin reuptake inhibitors']","['zolpidem ER versus placebo', 'zolpidem extended-release (ER) versus placebo']",[],"[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}]","[{'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],103.0,0.242734,"RESULTS


Patients guessed correctly 58.4% of the time, coordinators 53.9% of the time, and physicians 49.4% of the time, and none were different from chance alone.","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Benca', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Rumble', 'Affiliation': 'Department of Psychiatry, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Langley Porter Psychiatric Hospital and Clinics and Department of Psychiatry, University of California San Francisco, San Francisco, California, USA.'}]",Human psychopharmacology,['10.1002/hup.2757']
2779,32918332,Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the aesthetic zone of single immediate implants: A 1-year randomized controlled trial.,"BACKGROUND


Connective tissue grafting has a beneficial effect on the peri-implant mucosa, but the effect of grafting the buccal mucosa on buccal bone thickness (BBT) has not been investigated, although BBT is proposed to be a key factor for the soft-tissue contour. The aim of this trial was to assess the outcome of a connective tissue graft (CTG) in the aesthetic zone of single immediate implants on the change of BBT according to cone beam computed tomography (CBCT) scan analysis.
METHODS


In a 1-year randomized controlled trial, 60 patients received an immediately placed implant and provisionalization, either combined with CTG (test group) or without CTG (control group). CBCTs were taken pre-operatively (T pre  ) and 1 year after definitive restoration (T 2  ). Any change in BBT was assessed at different implant levels. Additionally, the change in mid-buccal mucosal level (MBML) and approximal marginal bone level were assessed.
RESULTS


Fifty-five patients were available for statistical analysis (test group, n = 28; control group, n = 27). At T 2  , the average change in BBT was significantly larger in the test group (-0.84 ± 0.61 mm) than in the control group (-0.46 ± 0.54 mm, P = 0.02). A MBML gain of 0.07 ± 0.85 mm in the test and a MBML loss -0.52 ± 1.16 mm in the control group was observed at T 2  . Average loss of marginal bone was 0.05 ± 0.33 mm and 0.01 ± 0.38 mm, respectively.
CONCLUSIONS


The application of CTG in the aesthetic zone of immediately placed and provisionalized implants is accompanied with more loss of BBT, but at the same time better maintains the mid-buccal mucosal level.",2020,"Average loss of marginal bone was 0.05 ± 0.33 mm and 0.01 ± 0.38 mm, respectively.
","['60 patients received an', 'aesthetic zone of single immediate implants']","['immediately placed implant and provisionalization, either combined with CTG (test group) or without CTG (control group', 'connective tissue graft (CTG', 'CTG', 'connective tissue grafting']","['change in mid-buccal mucosal level (MBML) and approximal marginal bone level', 'Average loss of marginal bone', 'average change in BBT', 'BBT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",60.0,0.180517,"Average loss of marginal bone was 0.05 ± 0.33 mm and 0.01 ± 0.38 mm, respectively.
","[{'ForeName': 'Elise G', 'Initials': 'EG', 'LastName': 'Zuiderveld', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wouter G', 'Initials': 'WG', 'LastName': 'van Nimwegen', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henny J A', 'Initials': 'HJA', 'LastName': 'Meijer', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Fixed and Removable Prosthodontics and Dental Material Science, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mühlemann', 'Affiliation': 'Clinic of Fixed and Removable Prosthodontics and Dental Material Science, Center of Dental Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Vissink', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gerry M', 'Initials': 'GM', 'LastName': 'Raghoebar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}]",Journal of periodontology,['10.1002/JPER.20-0217']
2780,32918588,Intra-individual physiological response of recreational runners to different training mesocycles: a randomized cross-over study.,"PURPOSE


Pronounced differences in individual physiological adaptation may occur following various training mesocycles in runners. Here we aimed to assess the individual changes in performance and physiological adaptation of recreational runners performing mesocycles with different intensity, duration and frequency.
METHODS


Employing a randomized cross-over design, the intra-individual physiological responses [i.e., peak ([Formula: see text]) and submaximal ([Formula: see text]) oxygen uptake, velocity at lactate thresholds (V 2 , V 4 )] and performance (time-to-exhaustion (TTE)) of 13 recreational runners who performed three 3-week sessions of high-intensity interval training (HIIT), high-volume low-intensity training (HVLIT) or more but shorter sessions of HVLIT (high-frequency training; HFT) were assessed.
RESULTS


[Formula: see text], V 2,  V 4  and TTE were not altered by HIIT, HVLIT or HFT (p > 0.05). [Formula: see text] improved to the same extent following HVLIT (p = 0.045) and HFT (p = 0.02). The number of moderately negative responders was higher following HIIT (15.4%); and HFT (15.4%) than HVLIT (7.6%). The number of very positive responders was higher following HVLIT (38.5%) than HFT (23%) or HIIT (7.7%). 46% of the runners responded positively to two mesocycles, while 23% did not respond to any.
CONCLUSION


On a group level, none of the interventions altered [Formula: see text], V 2 , V 4  or TTE, while HVLIT and HFT improved [Formula: see text]. The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT. 46% responded positively to two mesocycles, while 23% did not respond to any. These findings indicate that the magnitude of responses to HIIT, HVLIT and HFT is highly individual and no pattern was apparent.",2020,"The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT.","['recreational runners to different training mesocycles', '13 recreational runners', 'runners']","['high-intensity interval training (HIIT), high-volume low-intensity training (HVLIT) or more but shorter sessions of HVLIT (high-frequency training; HFT', 'submaximal ([Formula: see text]) oxygen uptake, velocity at lactate thresholds (V 2 , V 4 )] and performance (time-to-exhaustion (TTE']","['mean adaptation index', 'number of moderately negative responders', 'number of very positive responders']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0445362', 'cui_str': 'V 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0365246,"The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Düking', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany. Peter.dueking@uni-wuerzburg.de.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Swedish Winter Sports Research Centre, Department of Health Sciences, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kunz', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leppich', 'Affiliation': 'Chair of Software Engineering, Department of Computer Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Sperlich', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany.'}]",European journal of applied physiology,['10.1007/s00421-020-04477-4']
2781,32918607,Empowering caregivers in the radiotherapy process: the results of a randomized controlled trial.,"PURPOSE


The present study aims to evaluate the effectiveness of a mobile-assisted empowerment program developed specifically for caregivers of cancer patients undergoing radiotherapy.
METHODS


In this study, seventy-four individuals who gave care for cancer patients that received radiotherapy between September 2019 and May 2020 were randomized to receive a mobile-assisted empowerment program or standard care. The mobile-assisted empowerment program comprised of education and information related to the radiotherapy process, videos, activities, and question-and-answer modules to support caregivers during the radiotherapy process. Outcome measures were collected at baseline (day 1 of radiotherapy) and on day 21 and included caregiver demographics, distress, quality of life, and coping style using validated questionnaires.
RESULTS


Compared with baseline, individuals' mean scores of distress were lower in the empowerment group than the control group (p < 0.001). General quality of life and sub-dimension mean scores were higher in the empowerment group than the control group (p ≤ 0.05). There was no difference in the coping style average scores (p ≥ 0.05) between the two groups.
CONCLUSIONS


This study supports the findings that a mobile-supported empowerment program reduced the level of caregiver distress and increased quality of life during their loved one's treatment with radiotherapy.",2020,General quality of life and sub-dimension mean scores were higher in the empowerment group than the control group (p ≤ 0.05).,"['caregivers of cancer patients undergoing radiotherapy', 'seventy-four individuals who gave care for cancer patients that received radiotherapy between September 2019 and May 2020']","['mobile-assisted empowerment program or standard care', 'mobile-assisted empowerment program', 'radiotherapy']","['coping style average scores', 'General quality of life and sub-dimension mean scores', 'mean scores of distress', 'caregiver demographics, distress, quality of life, and coping style using validated questionnaires', 'level of caregiver distress', 'quality of life']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",74.0,0.120392,General quality of life and sub-dimension mean scores were higher in the empowerment group than the control group (p ≤ 0.05).,"[{'ForeName': 'Neşe', 'Initials': 'N', 'LastName': 'Uysal', 'Affiliation': 'Amasya University Faculty of Health Science, Amasya, Turkey. uysaln2007@hotmail.com.'}, {'ForeName': 'Gülcan', 'Initials': 'G', 'LastName': 'Bağçivan', 'Affiliation': 'Koç University School of Nursing , Istanbul, Turkey.'}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Özkaraman', 'Affiliation': 'Eskişehir Osmangazi University Faculty of Health Science, Eskişehir, Turkey.'}, {'ForeName': 'Akile', 'Initials': 'A', 'LastName': 'Karaaslan Eşer', 'Affiliation': 'Başkent University Faculty of Health Science, Ankara, Turkey.'}, {'ForeName': 'Ferhan', 'Initials': 'F', 'LastName': 'Çetin', 'Affiliation': 'Hacettepe University Hospital, Ankara, Turkey.'}, {'ForeName': 'Behice Belkıs', 'Initials': 'BB', 'LastName': 'Çalışkan', 'Affiliation': 'Beykent University School of Health Science, İstanbul, Turkey.'}, {'ForeName': 'Aygül', 'Initials': 'A', 'LastName': 'Elöz', 'Affiliation': 'Ankara Provincial Health Directorate, Ankara, Turkey.'}, {'ForeName': 'Emine İnce', 'Initials': 'Eİ', 'LastName': 'Gündoğdu', 'Affiliation': ""Lösante Children's and Adult Hospital, Ankara, Turkey.""}, {'ForeName': 'Gökçe Kaan', 'Initials': 'GK', 'LastName': 'Olcay', 'Affiliation': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Bektaş', 'Initials': 'B', 'LastName': 'Kaya', 'Affiliation': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Yeter', 'Initials': 'Y', 'LastName': 'Soylu', 'Affiliation': 'Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05743-z']
2782,32915638,Safety Aspects of a Randomized Clinical Trial of Maternal and Infant Vitamin D Supplementation by Feeding Type Through 7 Months Postpartum.,"Background:  The safety of higher dose vitamin D (vitD) supplementation in women who change from exclusive or full breastfeeding to combination feeding or who continue supplementation after cessation of breastfeeding is unknown.  Objective:  Compare vitD supplementation safety of 6,400 to 400 IU/day and 2,400 IU/day using specific laboratory parameters in postpartum women and their infants through 7 months postpartum by feeding type.  Design:  In this randomized controlled trial, mothers (exclusively breastfeeding or formula-feeding) were randomized at 4-6 weeks' postpartum to 400, 2,400, or 6,400 IU vitD 3  (cholecalciferol)/day for 6 months. Breastfeeding infants in 400 IU group received oral 400 IU vitD 3 /day; infants in 2,400 and 6,400 IU groups received placebo. Maternal safety parameters (serum vitD, 25-hydroxy-vitamin D [25(OH)D; calcidiol], calcium, phosphorus, intact PTH; urinary calcium/creatinine ratios; and feeding type/changes) were measured monthly; infant parameters were measured at months 1, 4, and 7. Sufficiency was defined as 25(OH)D >50 nmol/L. Feeding type was defined as exclusive/full, combination, or formula-feeding. Data were analyzed using SAS 9.4.  Results:  Four hundred nineteen mother-infant pairs were randomized into the three treatment groups and followed: 346 breastfeeding and 73 formula-feeding pairs. A dose of 6400 IU/day safely and significantly increased maternal vitD and 25(OH)D from baseline in all mothers regardless of feeding type ( p  < 0.0001) and was superior to the 400 and 2,400 IU groups in achieving vitD sufficiency with no other differences in safety parameters by treatment or feeding type. Infants in the 2,400 IU group were more likely vitD-deficient than the other groups; otherwise, there were no infant safety parameter differences.  Conclusions:  While 6,400 IU/day was more effective than 400 or 2,400 IU/day in achieving maternal vitD sufficiency in all feeding groups, the groups did not differ on other safety parameters. Similarly, infant safety parameters did not differ by treatment group or feeding status. Clinical Trial Registration: FDA IND Number: 66,346; ClinicalTrials.gov Number: NCT00412074.",2020,"A dose of 6400 IU/day safely and significantly increased maternal vitD and 25(OH)D from baseline in all mothers regardless of feeding type ( p  < 0.0001) and was superior to the 400 and 2,400 IU groups in achieving vitD sufficiency with no other differences in safety parameters by treatment or feeding type.","['Four hundred nineteen mother-infant pairs', 'mothers (exclusively breastfeeding or formula-feeding', 'women who change from exclusive or full breastfeeding to combination feeding or who continue supplementation after cessation of breastfeeding is unknown', 'postpartum women and their infants through 7 months postpartum by feeding type']","['placebo', 'oral 400 IU vitD', 'vitamin D (vitD) supplementation', 'Maternal and Infant Vitamin D Supplementation by Feeding Type']","['likely vitD-deficient', 'maternal vitD and 25(OH)D', 'Maternal safety parameters (serum vitD, 25-hydroxy-vitamin D [25(OH)D; calcidiol], calcium, phosphorus, intact PTH; urinary calcium/creatinine ratios; and feeding type/changes', 'maternal vitD sufficiency']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0919758', 'cui_str': 'Vitamin D measurement'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0428613', 'cui_str': 'Calcium/creatinine ratio measurement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.27662,"A dose of 6400 IU/day safely and significantly increased maternal vitD and 25(OH)D from baseline in all mothers regardless of feeding type ( p  < 0.0001) and was superior to the 400 and 2,400 IU groups in achieving vitD sufficiency with no other differences in safety parameters by treatment or feeding type.","[{'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Hulsey', 'Affiliation': 'Department of Epidemiology, West Virginia University, Morgantown, West Virginia, USA.'}, {'ForeName': 'Myla', 'Initials': 'M', 'LastName': 'Ebeling', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Golaleh', 'Initials': 'G', 'LastName': 'Asghari', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Howard', 'Affiliation': 'Department of Pediatrics, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Baatz', 'Affiliation': 'Department of Pediatrics and Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Danforth A', 'Initials': 'DA', 'LastName': 'Newton', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Reed', 'Affiliation': 'Department of Pediatrics and Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sarah N', 'Initials': 'SN', 'LastName': 'Taylor', 'Affiliation': 'Divison of Neonatology, Department of Pediatrics, Yale School of Medical School, New Haven, Connecticut, USA.'}, {'ForeName': 'Ruth A', 'Initials': 'RA', 'LastName': 'Lawrence', 'Affiliation': 'Department of Pediatrics, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, South Carolina, USA.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0056']
2783,32915670,Feasibility evaluation of psychosocial intervention for internally displaced youth in Kenya.,"BACKGROUND


There is limited evidence on the cultural appropriateness of first-stage psychosocial interventions for youth with mental health problems who experience conflict and disadvantage in low- and middle-income countries (LMIC).
AIMS


To evaluate the feasibility of such an intervention (Writing for Recovery - WfR) among youth with emerging emotional problems following internal displacement in Kenya.
METHOD


Fifty-four youth aged 14-17 years were randomly allocated to a six-session intervention or a waiting list control group. They completed measures of stressful life events; post-traumatic stress, depressive and anxiety symptoms; quality of life; and free text on their experience of the intervention.
RESULTS


Young participants reported high levels of trauma exposure and emotional problems. The intervention was perceived as flexible and culturally acceptable, with reported short-term impact. This was found to have promising post-intervention effect in reducing post-traumatic stress, but not depressive or anxiety symptoms; and in enhancing quality of life scores.
CONCLUSIONS


Similar psychosocial interventions that can be delivered by paraprofessionals are important for resource-constrained LMIC settings, but need to be integrated within a comprehensive scaled service model.",2020,"This was found to have promising post-intervention effect in reducing post-traumatic stress, but not depressive or anxiety symptoms; and in enhancing quality of life scores.
","['youth with emerging emotional problems following internal displacement in Kenya', 'Fifty-four youth aged 14-17 years', 'internally displaced youth in Kenya', 'youth with mental health problems who experience conflict and disadvantage in low- and middle-income countries (LMIC']","['psychosocial intervention', 'six-session intervention or a waiting list control group']","['depressive or anxiety symptoms', 'stressful life events; post-traumatic stress, depressive and anxiety symptoms; quality of life; and free text on their experience of the intervention', 'high levels of trauma exposure and emotional problems', 'post-traumatic stress']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}]",54.0,0.0515624,"This was found to have promising post-intervention effect in reducing post-traumatic stress, but not depressive or anxiety symptoms; and in enhancing quality of life scores.
","[{'ForeName': 'Elijah Mironga', 'Initials': 'EM', 'LastName': 'Getanda', 'Affiliation': 'Child and Adolescent Mental Health, University of Leicester, Leicester, UK.'}, {'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Vostanis', 'Affiliation': 'Child and Adolescent Mental Health, University of Leicester, Leicester, UK.'}]","Journal of mental health (Abingdon, England)",['10.1080/09638237.2020.1818702']
2784,32915892,"Comparison of nebivolol versus diltiazem in improving coronary artery spasm and quality of life in patients with hypertension and vasospastic angina: A prospective, randomized, double-blind pilot study.","BACKGROUND


Beta-blockers are often not the preferred treatment for patients with vasospastic angina. However, nebivolol, beta-blocker with nitric oxide-releasing effect, could theoretically improve coronary vasospasm. We compared nebivolol versus diltiazem in improving coronary vasospasm and quality of life in patients with hypertensive vasospastic angina during a 12-week follow-up.
METHODS


Fifty-one hypertensive patients with documented coronary vasospasm were randomly allocated into 3 treatment groups: (1) Nebivolol Group (5mg for 2 weeks/10mg for 10 weeks); (2) Diltiazem Group (90mg for 2 weeks/180mg for 10 weeks); (3) Low-dose Combination Group (2.5mg + 45mg for 2 weeks/5mg + 90mg for 10 weeks). The primary endpoint was to compare the percent changes in coronary vasospasm at 12 weeks from baseline among the 3 groups. The secondary endpoints included changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure at 12 weeks from baseline.
RESULTS


Significant improvements in coronary vasospasm were found in all groups; however, the improvement in percent changes in coronary artery spasm was greatest in the Diltiazem Group (50.4±8.8% vs. 67.8±12.8% vs. 46.8±12.3%, Nebivolol Group vs. Diltiazem Group p = 0.008; Nebivolol Group vs. Low-dose Combination Group p = 0.999; Diltiazem Group vs. Low-dose Combination Group p = 0.017). The overall Seattle Angina Questionnaire scores were significantly elevated at 12 weeks compared to the baseline in entire study population. There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
CONCLUSIONS


Both nebivolol and diltiazem showed significant coronary vasospasm reduction effect, but the effect was greater for diltiazem.",2020,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","['Fifty-one hypertensive patients with documented coronary vasospasm', 'patients with hypertensive vasospastic angina during a 12-week follow-up', 'patients with hypertension and vasospastic angina', 'patients with vasospastic angina']","['diltiazem', 'Diltiazem', 'nebivolol', 'Nebivolol', 'nebivolol and diltiazem']","['changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure', 'overall Seattle Angina Questionnaire score changes and blood pressure changes', 'coronary vasospasm', 'coronary artery spasm and quality of life', 'coronary vasospasm and quality of life', 'coronary vasospasm reduction effect', 'overall Seattle Angina Questionnaire scores', 'coronary artery spasm']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0002963', 'cui_str': 'Prinzmetal angina'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0068475', 'cui_str': 'nebivolol'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010073', 'cui_str': 'Coronary artery spasm'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",51.0,0.050534,"There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes.
","[{'ForeName': 'Hyungdon', 'Initials': 'H', 'LastName': 'Kook', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung-Sook', 'Initials': 'KS', 'LastName': 'Yang', 'Affiliation': 'Department of Biostatistics, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sunki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chang Gyu', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0239039']
2785,32915900,Impact of electrolyte-rich dialysate during continuous renal replacement therapy on serum phosphate and potassium in ICU patients.,"BACKGROUND


Hypophosphatemia and hypokalemia occur frequently during continuous renal replacement therapy (CRRT). We evaluated serum phosphate and potassium levels in patients administered three different types of dialysis solution.
METHODS


The study population consisted of 324 intensive care unit patients who underwent CRRT between January 2015 and December 2018. Patients were divided into three groups: group 1 (n = 105) received Hemosol B0 (no potassium or phosphate); group 2 (n = 78) received Hemosol B0 and potassium-containing solution (MultiBic); and group 3 (n = 141) received phosphate- and potassium-containing solution (Phoxilium), Hemosol B2, Prismasol 2, and Prismasol 4. A different protocol was followed in each group.
RESULTS


The incidence rate of hypophosphatemia was 55% lower in group 3 compared to group 1 (incidence rate ratio (IRR) 0.45, 95% confidence interval (CI): 0.33 to 0.61) and 61% lower compared to group 2 (IRR 0.39, 95% CI: 0.29 to 0.53). Group 3 also had a 50% lower incidence rate of hypokalemia compared to group 1 (IRR 0.50, 95% CI: 0.29 to 0.88). The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008). Additional intravenous calcium was not used in any case, and most cases of acid-base disturbances were well controlled.
CONCLUSIONS


The use of phosphate- and potassium-containing with a proper CRRT protocol prevented decreases in serum phosphate and potassium levels, thus also preventing hypophosphatemia and hypokalemia, and additional replacement during CRRT.",2020,"The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008).","['patients administered three different types of dialysis solution', 'ICU patients', '324 intensive care unit patients who underwent CRRT between January 2015 and December 2018']","['electrolyte-rich dialysate', 'Hemosol B0 and potassium-containing solution (MultiBic', 'Hemosol B0 (no potassium or phosphate', 'continuous renal replacement therapy (CRRT', 'Additional intravenous calcium', 'phosphate- and potassium-containing with a proper CRRT protocol', 'phosphate- and potassium-containing solution (Phoxilium), Hemosol B2, Prismasol 2, and Prismasol 4']","['incidence rate of hypophosphatemia', 'negative slope in the potassium level', 'incidence rate of hypokalemia', 'serum phosphate and potassium levels', 'negative slope in phosphate level', 'hypophosphatemia and hypokalemia', 'serum phosphate and potassium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]",,0.0800356,"The negative slope in phosphate level in group 3 was greater than that in group 1 (ß = 0.19, 95% CI: 0.02 to 0.37, p = 0.032), while the negative slope in the potassium level was greater in group 2 than in group 1(ß = 0.10, 95% CI: 0.03 to 0.17, p = 0.008).","[{'ForeName': 'AJin', 'Initials': 'A', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Ki', 'Initials': 'YK', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hayne Cho', 'Initials': 'HC', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0238867']
2786,32905675,Eflornithine plus Sulindac for Prevention of Progression in Familial Adenomatous Polyposis.,"BACKGROUND


The efficacy and safety of combination therapy with eflornithine and sulindac, as compared with either drug alone, in delaying disease progression in patients with familial adenomatous polyposis are unknown.
METHODS


We evaluated the efficacy and safety of the combination of eflornithine and sulindac, as compared with either drug alone, in adults with familial adenomatous polyposis. The patients were stratified on the basis of anatomical site with the highest polyp burden and surgical status; the strata were precolectomy (shortest projected time to disease progression), rectal or ileal pouch polyposis after colectomy (longest projected time), and duodenal polyposis (intermediate projected time). The patients were then randomly assigned in a 1:1:1 ratio to receive 750 mg of eflornithine, 150 mg of sulindac, or both once daily for up to 48 months. The primary end point, assessed in a time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease.
RESULTS


A total of 171 patients underwent randomization. Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine. Among 37 precolectomy patients, the corresponding values in the treatment groups were 2 of 12 patients (17%), 6 of 13 (46%), and 5 of 12 (42%) (hazard ratios, 0.30 [95% CI, 0.07 to 1.32] and 0.20 [95% CI, 0.03 to 1.32]); among 34 patients with rectal or ileal pouch polyposis, the values were 4 of 11 patients (36%), 2 of 11 (18%), and 5 of 12 (42%) (hazard ratios, 2.03 [95% CI, 0.43 to 9.62] and 0.84 [95% CI, 0.24 to 2.90]); and among 100 patients with duodenal polyposis, the values were 12 of 33 patients (36%), 14 of 34 (41%), and 13 of 33 (39%) (hazard ratios, 0.73 [95% CI, 0.34 to 1.52] and 0.76 [95% CI, 0.35 to 1.64]). Adverse and serious adverse events were similar across the treatment groups.
CONCLUSIONS


In this trial involving patients with familial adenomatous polyposis, the incidence of disease progression was not significantly lower with the combination of eflornithine and sulindac than with either drug alone. (Funded by Cancer Prevention Pharmaceuticals; ClinicalTrials.gov number, NCT01483144; EudraCT number, 2012-000427-41.).",2020,"Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine.","['37 precolectomy patients', 'Familial Adenomatous Polyposis', 'patients with familial adenomatous polyposis', 'adults with familial adenomatous polyposis', '171 patients underwent randomization']","['sulindac', 'eflornithine and sulindac', 'Eflornithine plus Sulindac', 'eflornithine-sulindac', 'eflornithine, 150 mg of sulindac']","['time-to-event analysis, was disease progression, defined as a composite of major surgery, endoscopic excision of advanced adenomas, diagnosis of high-grade dysplasia in the rectum or pouch, or progression of duodenal disease', 'efficacy and safety', 'incidence of disease progression', 'Adverse and serious adverse events', 'Disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032580', 'cui_str': 'Adenomatous polyposis coli'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0038792', 'cui_str': 'Sulindac'}, {'cui': 'C0002260', 'cui_str': 'Eflornithine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C4319584', 'cui_str': 'Pouch'}, {'cui': 'C0013289', 'cui_str': 'Disorder of duodenum'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",34.0,0.138184,"Disease progression occurred in 18 of 56 patients (32%) in the eflornithine-sulindac group, 22 of 58 (38%) in the sulindac group, and 23 of 57 (40%) in the eflornithine group, with a hazard ratio of 0.71 (95% confidence interval [CI], 0.39 to 1.32) for eflornithine-sulindac as compared with sulindac (P = 0.29) and 0.66 (95% CI, 0.36 to 1.24) for eflornithine-sulindac as compared with eflornithine.","[{'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Burke', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lynch', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'N Jewel', 'Initials': 'NJ', 'LastName': 'Samadder', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Balaguer', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hüneburg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castells', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Gallinger', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Stoffel', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Henderson', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Kallenberg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Kanth', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Victorine H', 'Initials': 'VH', 'LastName': 'Roos', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Ginsberg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Strassburg', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Church', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lalloo', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Field F', 'Initials': 'FF', 'LastName': 'Willingham', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Wise', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Grady', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Ford', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Weiss', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gryfe', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Rustgi', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Syngal', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ""From the Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland (C.A.B., J.C.); the Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam (E.D., F.G.K., V.H.R.); the Department of Gastroenterology, Hepatology, and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston (P.L.); the Division of Gastroenterology and Hepatology, Mayo Clinic, Phoenix (N.J.S.), and Cancer Prevention Pharmaceuticals, Tucson (A. Cohen) - both in Arizona; the Department of Gastroenterology, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, University of Barcelona, Barcelona (F.B., A. Castells); the Department of Internal Medicine I, University of Bonn (R.H., C.P.S.), and the National Center for Hereditary Tumor Syndromes (R.H., C.P.S.), Bonn, Germany; Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne (J.B., A.H.), and Manchester Centre for Genomic Medicine, Saint Mary's Hospital, Manchester (F.L.) - both in the United Kingdom; Mount Sinai Hospital, Toronto (S. Gallinger, R.G.); the Division of Population Sciences, Dana-Farber Cancer Institute, the Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, and Harvard Medical School - all in Boston (R.L., S.S.); the Division of Gastroenterology, University of Michigan, Ann Arbor (E.M.S.); Veterans Affairs San Diego Healthcare System, San Diego, and the Division of Gastroenterology, University of California San Diego, La Jolla (S. Gupta); Huntsman Cancer Center, Salt Lake City (P.K.); the University of Pennsylvania, Philadelphia (G.G.G., A.K.R.); Mayo Clinic, Rochester, MN (F.A.S.); University Hospital Gasthuisberg, Leuven, Belgium (E.V.C.); Emory University School of Medicine, Atlanta (F.F.W.); Washington University School of Medicine, St. Louis (P.E.W.); University of Washington Medical Center, Seattle (W.M.G.); Vanderbilt University Medical Center, Nashville (M.F.); and the University of Wisconsin School of Medicine and Public Health, Madison (J.M.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1916063']
2787,32905676,"Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide.","BACKGROUND


Darolutamide is a structurally distinct androgen-receptor inhibitor that is approved for the treatment of nonmetastatic, castration-resistant prostate cancer. In the planned primary analysis of a phase 3 trial, the median metastasis-free survival was significantly longer with darolutamide (40.4 months) than with placebo (18.4 months). The data for the analysis of overall survival were immature at the time of the primary analysis.
METHODS


In this double-blind, placebo-controlled trial, we randomly assigned 1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or placebo (554 patients) while they continued to receive androgen-deprivation therapy. After the results of the primary end-point analysis were found to be positive, unblinding of the treatment assignments occurred, and patients in the placebo group were permitted to cross over to receive open-label darolutamide treatment. At the time of this prespecified final analysis, which had been planned to be performed after approximately 240 deaths had occurred, overall survival and all other secondary end points were evaluated.
RESULTS


The median follow-up time was 29.0 months. At the time of unblinding of the data, all 170 patients who were still receiving placebo crossed over to receive darolutamide; 137 patients who had discontinued placebo before unblinding had occurred received at least one other life-prolonging therapy. Overall survival at 3 years was 83% (95% confidence interval [CI], 80 to 86) in the darolutamide group and 77% (95% CI, 72 to 81) in the placebo group. The risk of death was significantly lower, by 31%, in the darolutamide group than in the placebo group (hazard ratio for death, 0.69; 95% CI, 0.53 to 0.88; P = 0.003). Darolutamide was also associated with a significant benefit with respect to all other secondary end points, including the time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy. The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
CONCLUSIONS


Among men with nonmetastatic, castration-resistant prostate cancer, the percentage of patients who were alive at 3 years was significantly higher among those who received darolutamide than among those who received placebo. The incidence of adverse events was similar in the two groups. (Funded by Bayer HealthCare and Orion Pharma; ARAMIS ClinicalTrials.gov number, NCT02200614.).",2020,"The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
","['1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or', 'men with nonmetastatic, castration-resistant prostate cancer', '170 patients who were still receiving']","['androgen-deprivation therapy', 'placebo']","['Overall survival', 'risk of death', 'adverse events', 'median metastasis-free survival', 'time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy', 'incidence of adverse events', 'overall survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C4517599', 'cui_str': '170'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",1509.0,0.695659,"The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed.
","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Ulys', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Egils', 'Initials': 'E', 'LastName': 'Vjaters', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Polyakov', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Jievaltas', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Luz', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Kuss', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Le Berre', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Snapir', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Sarapohja', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) - both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) - both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) - both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov National Cancer Center of Belarus, Minsk, Belarus (S.P.); Hospital Erasto Gaertner, Curitiba, Brazil (M.L.); the National Medical Research Radiological Center, Ministry of Health of the Russian Federation, Moscow (B.A.); Clinical Statistics, Bayer, Berlin (I.K.); Bayer Healthcare, Whippany, NJ (O.P.); and the Massachusetts General Hospital Cancer Center, Boston (M.R.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001342']
2788,32903140,Age Dependency of the Prognostic Impact of Tumor Genomics in Localized Resectable  MYCN -Nonamplified Neuroblastomas. Report From the SIOPEN Biology Group on the LNESG Trials and a COG Validation Group.,"PURPOSE


For localized, resectable neuroblastoma without  MYCN  amplification, surgery only is recommended even if incomplete. However, it is not known whether the genomic background of these tumors may influence outcome.
PATIENTS AND METHODS


Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts: Localized Neuroblastoma European Study Group I/II and Children's Oncology Group. Genomic data were analyzed using multi- and pangenomic techniques and fluorescence in-situ hybridization in 2 age groups (cutoff age, 18 months) and were quality controlled by the International Society of Pediatric Oncology European Neuroblastoma (SIOPEN) Biology Group.
RESULTS


Patients with stage 1 tumors had an excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD], 95% ± 2%; 5-year overall survival [OS], 99% ± 1%). In contrast, patients with stage 2 tumors had a reduced EFS in both age groups (5-year EFS ± SD, 84% ± 3% in patients < 18 months of age and 75% ± 7% in patients ≥ 18 months of age). However, OS was significantly decreased only in the latter group (5-year OS ± SD in < 18months and ≥ 18months, 96% ± 2% and 81% ± 7%, respectively;  P  = .001). In < 18months, relapses occurred independent of segmental chromosome aberrations (SCAs); only 1p loss decreased EFS (5-year EFS ± SD in patients 1p loss and no 1p loss, 62% ± 13% and 87% ± 3%, respectively;  P  = .019) but not OS (5-year OS ± SD, 92% ± 8% and 97% ± 2%, respectively). In patients ≥ 18 months, only SCAs led to relapse and death, with 11q loss as the strongest marker (11q loss and no 11q loss: 5-year EFS ± SD, 48% ± 16% and 85% ± 7%,  P  = .033; 5-year OS ± SD, 46% ± 22% and 92% ± 6%,  P  = .038).
CONCLUSION


Genomic aberrations of resectable non- MYCN- amplified stage 2 neuroblastomas have a distinct age-dependent prognostic impact. Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months. In older patients with SCA, a randomized trial of postoperative chemotherapy compared with observation alone may be indicated.",2020,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","['older patients with SCA', 'Diagnostic samples were obtained from 317 tumors, International Neuroblastoma Staging System stages 1/2A/2B, from 3 cohorts']",['postoperative chemotherapy'],"['excellent outcome (5-year event-free survival [EFS] ± standard deviation [SD', 'EFS (5-year EFS ± SD', '5-year overall survival [OS', 'OS', 'relapse and death']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}]","[{'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0953821,"Chromosome 1p loss is a risk factor for relapse but not for diminished OS in patients < 18 months, SCAs (especially 11q loss) are risk factors for reduced EFS and OS in those > 18months.","[{'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Gian-Paolo', 'Initials': 'GP', 'LastName': 'Tonini', 'Affiliation': 'Paediatric Research Institute, Fondazione Città della Speranza, Neuroblastoma Laboratory, Padua, Italy.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Pötschger', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Gross', 'Affiliation': 'Pediatric Oncology Research, Department of Pediatrics, University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Mosseri', 'Affiliation': 'Service de Biostatistiques, Institut Curie, Paris, France.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Beiske', 'Affiliation': 'Department of Pathology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Berbegall', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bénard', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bown', 'Affiliation': 'Northern Genetics Service, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Huib', 'Initials': 'H', 'LastName': 'Caron', 'Affiliation': ""Department of Pediatric Oncology, Emma Children's Hospital, Academic Medical Center, Amsterdam, the Netherlands.""}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Combaret', 'Affiliation': 'Centre Léon Bérard, Laboratoire de Recherche Translationnelle, Lyon, France.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Couturier', 'Affiliation': 'Unité de Génétique Somatique et Cytogénétique, Institut Curie, Paris, France.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Defferrari', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Delattre', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jeison', 'Affiliation': ""Ca-Cytogenetic Laboratory, Pediatric Hematology Oncology Department, Schneider Children's Medical Center of Israel, Petah Tikvah, Israel.""}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kogner', 'Affiliation': ""Childhood Cancer Research Unit, Karolinska Institutet, Astrid Lindgren Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lunec', 'Affiliation': 'Biosciences Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Marques', 'Affiliation': 'Centro de Genética Humana, Instituto Nacional de Saude doutor Ricardo Jorge, Lisbon, Portugal.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Martinsson', 'Affiliation': 'Department of Clinical Genetics, Institute of Biomedicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Department of Pathology, Istituto G. Gaslini, Genoa, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Noguera', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Schleiermacher', 'Affiliation': 'INSERM U830, Laboratoire de Génétique et Biologie des Cancers, Paris, France.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valent', 'Affiliation': 'Département de Biologie et de Pathologie Médicales, Service de Pathologie Moléculaire, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Van Roy', 'Affiliation': 'Center for Medical Genetics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Villamon', 'Affiliation': 'Department of Pathology, Medical School, University of Valencia-Fundación de Investigación del Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Dasa', 'Initials': 'D', 'LastName': 'Janousek', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Pribill', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Glogova', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Attiyeh', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hogarty', 'Affiliation': ""Division of Oncology, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Monclair', 'Affiliation': 'Section for Paediatric Surgery, Division of Surgery, Rikshospitalet University Hospital, Oslo, Norway.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Holmes', 'Affiliation': ""Department of Paediatric Surgery, St George's Hospital, London, UK.""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Valteau-Couanet', 'Affiliation': ""Département de Cancérologie de l'Enfant et de l'Adolescent, Gustave Roussy, Villejuif, France.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Castel', 'Affiliation': 'Unidad de Oncologia Pediatrica Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Tweddle', 'Affiliation': 'Wolfson Childhood Cancer Research Centre, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, WA.""}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, The University of Chicago, Chicago, IL.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Beck-Popovic', 'Affiliation': 'Pediatric Hematology Oncology Unit, University Hospital of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'De Bernardi', 'Affiliation': ""Department of Paediatric Haematology and Oncology, Giannina Gaslini Children's Hospital, Genova, Italy.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Michon', 'Affiliation': 'Département de Pédiatrie, Institut Curie, Paris, France.'}, {'ForeName': 'Andrew D J', 'Initials': 'ADJ', 'LastName': 'Pearson', 'Affiliation': 'Institute of Cancer Research, Royal Marsden Hospital, Sutton, Surrey, United Kingdom.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Ambros', 'Affiliation': ""Children's Cancer Research Institute, St Anna Kinderkrebsforschung, Vienna, Austria.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02132']
2789,32903168,Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study.,"OBJECTIVES


Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions.
METHODS


In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon,  n  = 50; POBA,  n  = 45). The primary endpoints were primary patency and clinically driven target lesion revascularization (CD-TLR) at 24 months. The secondary endpoints were late lumen loss at six months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index at 24 months.
RESULTS


Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively;  P  < 0.001). The 24-month primary patency rate was significantly higher in the drug-coated balloon than POBA group (53.85% vs. 17.50%, respectively;  P  < 0.001). The CD-TLR rate in the drug-coated balloon and POBA groups was 12.77 and 45.24%, respectively ( P  = 0.002). The 24-month overall mortality rate in the drug-coated balloon and POBA groups was 12.77% and 6.98%, respectively ( P  = 0.360), with no device- or procedure-related deaths. One major amputation had occurred in each group by the 24-month follow-up.
CONCLUSION


The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24 months after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.",2020,The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24 months after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.,"['95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon,  n \u2009=\u200950; POBA,  n \u2009=\u200945', 'total occlusions with severe femoropopliteal lesions']","['paclitaxel drug-coated balloon', 'drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA', 'drug-coated balloon angioplasty', 'drug-coated balloon angioplasty versus uncoated balloon angioplasty']","['six-month late-lumen loss rate', '24-month primary patency rate', 'primary patency and clinically driven target lesion revascularization (CD-TLR', '24-month overall mortality rate', 'CD-TLR rate', 'late lumen loss at six\u2009months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}]",95.0,0.0559034,The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24 months after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.,"[{'ForeName': 'Guoyi', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Senhao', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jiwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Vascular Surgery, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Baixi', 'Initials': 'B', 'LastName': 'Zhuang', 'Affiliation': 'Department of Peripheral Vascular Disease, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jia', 'Affiliation': 'Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Vascular Surgery, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Danming', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Vascular Surgery, The People's Hospital of Liaoning Province, Shenyang, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Therapy, The First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Pingfan', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Bi', 'Affiliation': 'Department of Vascular Surgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Shenming', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Vascular Surgery, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vascular,['10.1177/1708538120953663']
2790,32903172,"A single-arm study to evaluate the transfer of drospirenone to breast milk after reaching steady state, following oral administration of 4 mg drospirenone in healthy lactating female volunteers.","OBJECTIVE


The primary objective of this trial was to assess the transfer of drospirenone to breast milk after daily administration of an oral test preparation containing 4 mg of drospirenone at the steady state. The secondary objective of the trial was to assess safety based on clinical and laboratory measurements and reporting of adverse events and/or adverse drug reactions.
PATIENTS AND METHODS


This was an open label, non-comparative single-center study. Drospirenone 4 mg per day was the first postpartum contraceptive for the study participants who were no longer breastfeeding yet were still lactating. It was administered for 7 days to achieve steady-state concentration. All participants were volunteers who planned to use oral contraceptives as their family planning method in the future.
RESULTS


Twelve volunteers completed the trial according to the protocol, and the samples of all 12 study completers were analyzed. The average concentration-time curve of drospirenone in plasma 24 h after the administration of the last dose (area under the curve (0-24 h)) was 635.33 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 1180.57 ng h/mL, respectively. The average C max  was 48.64 ng/mL.The average concentration-time curve of drospirenone in milk 24 h after the administration of the last dose (area under the curve (0-24 h)) was 134.35 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 227.17 ng h/mL, respectively. The average C max  was 10.34 ng/mL.
CONCLUSION


On average, 18.13% of plasma drospirenone made it to breast milk and the highest concentration of drospirenone in breast milk was 17.55% of that in plasma. The total quantity of drospirenone passing to breast milk is on average 4478 ng during a 24-h period representing 0.11% of the maternal daily dose. Thus, at the recommended doses, no effects on breastfed newborns/infants are anticipated with drospirenone 4 mg.",2020,"The average concentration-time curve of drospirenone in plasma 24 h after the administration of the last dose (area under the curve (0-24 h)) was 635.33 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 1180.57 ng h/mL, respectively.","['Twelve volunteers completed the trial according to the protocol, and the samples of all 12 study completers were analyzed', 'healthy lactating female volunteers', 'All participants were volunteers who planned to use oral contraceptives as their family planning method in the future']","['plasma drospirenone', 'Drospirenone', 'drospirenone']","['average concentration-time curve', 'total quantity of drospirenone passing to breast milk']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",12.0,0.102754,"The average concentration-time curve of drospirenone in plasma 24 h after the administration of the last dose (area under the curve (0-24 h)) was 635.33 ng h/mL and 120 h after the single repeated dose administration (area under the curve (0-120 h)) was 1180.57 ng h/mL, respectively.","[{'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Melka', 'Affiliation': 'Riga Maternity Hospital, Riga, Latvia.'}, {'ForeName': 'Kalev', 'Initials': 'K', 'LastName': 'Kask', 'Affiliation': 'EGeen International Corporation, Mountain View, CA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, Madrid, Spain.'}, {'ForeName': 'Pedro-Antonio', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Ismaning, Germany.'}]","Women's health (London, England)",['10.1177/1745506520957192']
2791,32903261,Impact of a pre-feeding oral stimulation program on first feed attempt in preterm infants: Double-blind controlled clinical trial.,"OBJECTIVE


To evaluate the effect of an oral stimulation program in preterm on the performance in the first oral feeding, oral feeding skills and transition time from tube to total oral intake.
STUDY DESIGNER


Double-blind randomized clinical trial including very preterm newborns. Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis were excluded. Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation once a day for 15 minutes, during a 10-day period. Control group (GII) received sham procedure with same duration of time. Feeding ability was assessed by a speech-language pathologist blinded to group assignment. The classification of infants' oral performance was determined by Oral Feeding Skills (OFS). Neonates were monitored until hospital discharge.
RESULTS


Seventy-four (37 in each group) were randomized. Mean gestational ages and birth weights were 30±1.4 and 30±1.5 weeks, and 1,452±330g and 1,457±353g for intervention and control groups, respectively. Infants in the intervention group had significantly better rates than infants in the control group on: mean proficiency (PRO) (41.5%±18.3 vs. 19.9%±11.6 (p<0.001)), transfer rate (RT) (2.3 mL/min and 1.1 mL/min (p<0.001)) and overall transfer (OT) (57.2%±19.7 and 35.0%±15.7 (p<0.001)). Median transition time from tube to oral feeding was 4 (3-11) and 8 (7-13) days in intervention and control groups, respectively (p = 0.003). Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
CONCLUSION


Infants who were breast-fed and an oral stimulation program proved beneficial in reducing transition time from tube feeding to oral feeding.
TRIAL REGISTRATION


ClinicalTrials.gov number NCT03025815.",2020,"Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
","['preterm infants', 'very preterm newborns', 'Seventy-four (37 in each group) were randomized']","['Intervention group (GI) received an oral stimulation program of tactile extra-, peri-, and intraoral tactile manipulation', 'oral stimulation program', 'pre-feeding oral stimulation program']","['transition time', 'Mean gestational ages and birth weights', 'Median transition time from tube to oral feeding', 'overall transfer (OT', 'Feeding ability', 'mean proficiency (PRO', 'transfer rate (RT', 'Congenital malformations, intracranial hemorrhage grade III or IV, bronchopulmonary dysplasia, and necrotizing enterocolitis', 'better rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0429944', 'cui_str': 'Feeding ability'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",,0.179173,"Intake of breast milk was found to reduce transition time from tube feeds to exclusive oral feeding (p<0.001, HR 1.01, 95%CI 1.005-1.019), but the impact of the study intervention remained significant (p = 0.007, HR 1.97, 95%CI 1.2-3.2).
","[{'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'da Rosa Pereira', 'Affiliation': 'Department of Speech-Language Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Deborah Salle', 'Initials': 'DS', 'LastName': 'Levy', 'Affiliation': 'Department of Speech-Language Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Renato S', 'Initials': 'RS', 'LastName': 'Procianoy', 'Affiliation': 'Department of Pediatrics, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Rita C', 'Initials': 'RC', 'LastName': 'Silveira', 'Affiliation': 'Department of Pediatrics, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}]",PloS one,['10.1371/journal.pone.0237915']
2792,32916181,The effects of an exercise training on steroid hormones in preadolescent children - A moderator for enhanced cognition?,"OBJECTIVE


Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS


In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS


Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1  to t 2  were predicting higher working memory performance post-intervention (β = 0.45, R 2  = 0.16, p = 0.038).
CONCLUSION


Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
2793,32916236,"Radiation-induced lymphopenia during chemoradiation therapy for non-small cell lung cancer is linked with age, lung V5, and XRCC1 rs25487 genotype in lymphocytes.","BACKGROUND & PURPOSE


We investigated clinical and genetic factors associated with severe radiation-induced lymphopenia (RIL) in a randomized clinical trial of photon vs. proton radiation, with chemotherapy, for non-small cell lung cancer.
METHODS


XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples. Severe RIL was defined as absolute lymphocyte count (ALC) <0.3×10 9  cells/L. Univariate and multivariate analyses were used to identify independent risk factors, which were then used to group patients according to risk of severe RIL.
RESULTS


Univariate analysis of the 178 patients in this analysis showed that older age, larger tumors, higher lung V5 and mean lung dose, and higher heart V5 and mean heart dose were associated with severe RIL during treatment (P<0.05). The XRCC1 rs25487 AA genotype was also associated with increased risk of severe RIL during treatment (AA vs. others: hazard ratio [HR] =1.065, 95% confidence interval [CI] 1.089-2.500, P = 0.018). Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL. These three risk factors (age ≥56 years, lung V5 ≥51% and XRCC1 rs25487 AA) distinguished patients at different risk of developing severe RIL (P<0.001).
CONCLUSIONS


Age, lung V5 and XRCC1 rs25487 AA were all linked with risk of severe RIL. Our predictive risk model may be helpful for identifying patients at high risk of severe RIL so that treatment can be modified.",2020,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.",['XRCC1 rs25487 was genotyped in lymphocytes from serial peripheral blood samples'],"['Radiation-induced lymphopenia during chemoradiation therapy', 'photon vs. proton radiation, with chemotherapy']","['lung V5', 'Severe RIL', 'severe RIL', 'absolute lymphocyte count (ALC', 'risk of severe RIL']","[{'cui': 'C0250029', 'cui_str': 'XRCC1 protein, human'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0033727', 'cui_str': 'Proton'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",178.0,0.0968706,"Multivariate analyses showed that older age (HR=1.031, 95% CI 1.009-1.054, P=0.005), lung V5 (HR=1.039, 95% CI 1.023-1.055, P<0.001), and AA genotype (AA vs. others, HR=1.768, 95% CI 1.165-2.684, P=0.007) were independently associated with higher incidence of severe RIL.","[{'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Welsh', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hekun', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Hunan Key Laboratory of Translational Radiation Oncology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: TXu@mdanderson.org.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.09.002']
2794,32916329,"Effectiveness of antimicrobial photodynamic therapy in restoring clinical, microbial, proinflammatory cytokines and pain scores in adolescent patients having generalized gingivitis and undergoing fixed orthodontic treatment: Short title: Gingivitis; pain; photodynamic therapy and orthodontic treatment.","BACKGROUND


The aim of the present study was to evaluate the effectiveness of photodynamic therapy (PDT) on clinical gingival inflammatory parameters, bacterial load, proinflammatory cytokine status, and pain scores in adolescent patients undergoing fixed orthodontic treatment with gingivitis.
METHODS


Thirty adolescent undergoing fixed orthodontic treatment with gingivitis were randomly divided into two groups: Group A - patients undergoing dental scaling (DS) with adjunctive photodynamic therapy (PDT) and Group B - DS alone. Clinical gingival parameters including plaque scores, (PS), bleeding on probing (BOP) and probing depth (PD) were assessed. Visual analogue scale (VAS) and McGill Pain Questionnaire (MPQ) were used to report the values of present pain intensity. Crevicular fluid was sampled to quantify the levels of interleukin (IL)-6 and tumor necrosis factor (TNF)-α using enzyme-linked immunosorbent assay. The total bacterial counts for Porphyromonas gingivalis (P. gingivalis) and Tannerella forsythia (T. forsythia) were assessed. All examinations were performed at baseline, 1 week and 4 weeks.
RESULTS


Both the treatment regimens reported statistically significant reduction in PS and BOP (p < 0.05). However, no significant difference was observed in PS and PD values when Group B was compared with Group A (p > 0.05). There was a statistically significant reduction noted for BOP in Group B when compared to Group A (p < 0.05). There was a statistically significant reduction in the microbial counts of T. forsythia in Group A when compared to Group B at week-1 (p < 0.05). During the 4-week follow-up, the counts for T. forsythia significantly increased. No significant changes could be seen in either of the pain scores in both the groups (p > 0.05). Both groups showed statistically significant reduction in the IL-6 and TNF-α levels. However, IL-6 was significantly reduced at 1 week, while TNF-a significantly reduced at 4 weeks of follow up among the participants in Group B.
CONCLUSION


PDT has a positive effect in significantly reducing the periodontal microbial load in established gingivitis in adolescent patients undergoing fixed orthodontic treatment.",2020,No significant changes could be seen in either of the pain scores in both the groups (p > 0.05).,"['adolescent patients having generalized gingivitis and undergoing fixed orthodontic treatment', 'adolescent patients undergoing fixed orthodontic treatment with gingivitis', 'adolescent patients undergoing fixed orthodontic treatment', 'Thirty adolescent undergoing fixed orthodontic treatment with gingivitis']","['Group A - patients undergoing dental scaling (DS) with adjunctive photodynamic therapy (PDT) and Group B - DS alone', 'antimicrobial photodynamic therapy', 'photodynamic therapy (PDT']","['Clinical gingival parameters including plaque scores, (PS), bleeding on probing (BOP) and probing depth (PD', 'PS and PD values', 'periodontal microbial load', 'clinical gingival inflammatory parameters, bacterial load, proinflammatory cytokine status, and pain scores', 'microbial counts of T. forsythia', 'total bacterial counts for Porphyromonas gingivalis (P. gingivalis) and Tannerella forsythia (T. forsythia', 'IL-6', 'IL-6 and TNF-α levels', 'PS and BOP', 'Visual analogue scale (VAS) and McGill Pain Questionnaire (MPQ', 'levels of interleukin (IL)-6 and tumor necrosis factor (TNF)-α using enzyme-linked immunosorbent assay', 'restoring clinical, microbial, proinflammatory cytokines and pain scores', 'pain scores', 'BOP']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0314961', 'cui_str': 'Tannerella forsythia'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}]",30.0,0.0190167,No significant changes could be seen in either of the pain scores in both the groups (p > 0.05).,"[{'ForeName': 'Hosam Ali', 'Initials': 'HA', 'LastName': 'Baeshen', 'Affiliation': 'Pedodontics and Orthodontic Department, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Alshahrani', 'Affiliation': 'Pedodontics and Orthodontic Department, College of Dentistry, King Abdul Aziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Muhammad Abdullah', 'Initials': 'MA', 'LastName': 'Kamran', 'Affiliation': 'Pedodontics and Orthodontic Department, College of Dentistry, King Abdul Aziz University, Jeddah, Saudi Arabia. Electronic address: muhammadabdkam@gmail.com.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'A Alnazeh', 'Affiliation': 'Pedodontics and Orthodontic Department, College of Dentistry, King Abdul Aziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alhaizaey', 'Affiliation': 'Pedodontics and Orthodontic Department, College of Dentistry, King Abdul Aziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alshahrani', 'Affiliation': 'Pedodontics and Orthodontic Department, College of Dentistry, King Abdul Aziz University, Jeddah, Saudi Arabia.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101998']
2795,32916339,The Effects of Respiratory Rehabilitation Program on Perceived Self-Efficacy and Dyspnea in Patients with Lung Cancer.,"PURPOSE


This study aims to examine the effects of respiratory rehabilitation program on perceived self-efficacy and dyspnea in lung cancer patients.
METHOD


This is a quasi-experimental with a two-group repeated measure design with pre-test and post-test at week 4 th  and week 8 th . The theory of self-efficacy's Bandura was used as the conceptual framework. The sample were patients with non-small cell lung cancer (NSCLC) stage four who visited Oncology clinic in a university hospital. Twenty-eight patients were enrolled and equally allocated to control group and experimental group. The control group received routine nursing care only while the experimental group received the respiratory rehabilitation program. The program comprised of dyspnea educating, breathing exercise, using hand-held fan, effective cough, respiratory strengthening muscle training and follow up by phone in third and sixth week. Data for perceived self-efficacy and dyspnea were collected before program start and reassessment in fourth and eighth week. Instrumentation were composed of the respiratory rehabilitation program, demographic data, perceived self-efficacy assessment for respiratory rehabilitation and the cancer dyspnea scale. Data were analyzed using descriptive statistics, One-factor repeated measure ANOVA and compare mean between groups.
RESULT


The result revealed that almost all of the sample were men and the mean age of experimental group was 65. 80 years (SD = 8.80) and control group was 73.00 years (SD = 7.60). There was significant different in mean score of perceived self-efficacy and dyspnea between the experimental group and the control group (p <.050).
CONCLUSION


Based on finding of the study, the respiratory rehabilitation program should be used in order to promote self-efficacy and relieve dyspnea in lung cancer patients.",2020,"There was significant different in mean score of perceived self-efficacy and dyspnea between the experimental group and the control group (p <.050).
","['Patients with Lung Cancer', 'patients with non-small cell lung cancer (NSCLC) stage four who visited Oncology clinic in a university hospital', 'lung cancer patients', 'Twenty-eight patients']","['dyspnea educating, breathing exercise, using hand-held fan, effective cough, respiratory strengthening muscle training and follow up by phone in third and sixth week', 'Respiratory Rehabilitation Program', 'routine nursing care only while the experimental group received the respiratory rehabilitation program', 'respiratory rehabilitation program']","['Perceived Self-Efficacy and Dyspnea', 'self-efficacy and dyspnea', 'demographic data, perceived self-efficacy assessment for respiratory rehabilitation and the cancer dyspnea scale', 'mean score of perceived self-efficacy and dyspnea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0441039', 'cui_str': 'Fan'}, {'cui': 'C0577920', 'cui_str': 'Effective cough'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",28.0,0.0131846,"There was significant different in mean score of perceived self-efficacy and dyspnea between the experimental group and the control group (p <.050).
","[{'ForeName': 'Pramote', 'Initials': 'P', 'LastName': 'Saetan', 'Affiliation': 'Master of Nursing Science Program (Adult Nursing), Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: pramote.benz@gmail.com.'}, {'ForeName': 'Suchira', 'Initials': 'S', 'LastName': 'Chaiviboontham', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: suchira.cha@mahido.edu.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Pokpalagon', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: piyawan.pok@mahidol.ac.th.'}, {'ForeName': 'Pichai', 'Initials': 'P', 'LastName': 'Chansriwong', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: pichai.chan@mahidol.ac.th.'}]",Asian nursing research,['10.1016/j.anr.2020.08.010']
2796,32916658,Creatine Supplementation Does Not Influence the Ratio Between Intracellular Water and Skeletal Muscle Mass in Resistance-Trained Men.,"The authors aimed to compare the effects of creatine (Cr) supplementation combined with resistance training on skeletal muscle mass (SMM), total body water, intracellular water (ICW), and extracellular water (ECW) in resistance-trained men as well as to determine whether the SMM/ICW ratio changes in response to the use of this ergogenic aid. Twenty-seven resistance-trained men received either Cr (n = 14) or placebo (n = 13) over 8 weeks. During the same period, subjects performed two split resistance training routines four times per week. SMM was estimated from appendicular lean soft tissue assessed by dual-energy X-ray absorptiometry. Total body water, ICW, and ECW were determined by spectral bioelectrical impedance. Both groups showed improvements (p < .05) in SMM, total body water, and ICW, with greater values observed for the Cr group compared with placebo. ECW increased similarly in both groups (p < .05). The SMM/ICW ratio did not change in either group (p > .05), whereas the SMM/ECW ratio decreased only in the Cr group (p < .05). A positive correlation was observed (p < .05) between SMM and ICW changes (r = .71). The authors' results suggest that the increase in muscle mass induced by Cr combined with resistance training occurs without alteration of the ratio of ICW to SMM in resistance-trained men.",2020,"Both groups showed improvements (p < .05) in SMM, total body water, and ICW, with greater values observed for the Cr group compared with placebo.","['Resistance-Trained Men', 'Twenty-seven resistance-trained men received either Cr (n = 14) or']","['Creatine Supplementation', 'placebo', 'creatine (Cr) supplementation combined with resistance training']","['SMM/ICW ratio', 'ECW', 'skeletal muscle mass (SMM), total body water, intracellular water (ICW), and extracellular water (ECW', 'Ratio Between Intracellular Water and Skeletal Muscle Mass', 'Total body water, ICW, and ECW', 'SMM, total body water, and ICW', 'SMM/ECW ratio']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}]",27.0,0.0463911,"Both groups showed improvements (p < .05) in SMM, total body water, and ICW, with greater values observed for the Cr group compared with placebo.","[{'ForeName': 'Alex S', 'Initials': 'AS', 'LastName': 'Ribeiro', 'Affiliation': 'University of Northern Paraná.'}, {'ForeName': 'Ademar', 'Initials': 'A', 'LastName': 'Avelar', 'Affiliation': 'State University of Maringá.'}, {'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Nunes', 'Affiliation': 'Londrina State University.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Schoenfeld', 'Affiliation': 'CUNY Lehman College.'}, {'ForeName': 'Andreo F', 'Initials': 'AF', 'LastName': 'Aguiar', 'Affiliation': 'University of Northern Paraná.'}, {'ForeName': 'Michele C C', 'Initials': 'MCC', 'LastName': 'Trindade', 'Affiliation': 'State University of Maringá.'}, {'ForeName': 'Analiza M', 'Initials': 'AM', 'LastName': 'Silva', 'Affiliation': 'Universidade de Lisboa.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Universidade de Lisboa.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Londrina State University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0080']
2797,32916792,Feasibility and Preliminary Efficacy of a Foot-Ankle Exercise Program Aiming to Improve Foot-Ankle Functionality and Gait Biomechanics in People with Diabetic Neuropathy: A Randomized Controlled Trial.,"Foot-ankle strengthening and mobility exercises are part of international guideline recommendations for people at risk of diabetic foot disease. We examined the feasibility and preliminary efficacy of a 12-week foot-ankle exercise program on clinical, functional and biomechanical outcomes in people with diabetic neuropathy (DPN). We randomly allocated 30 people with DPN to usual care (control) or usual care plus a supervised exercise program (intervention). For feasibility, we assessed recruitment rate and participant adherence and satisfaction. For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05). In 52 weeks, we recruited 45 eligible participants (0.90/week). Program adherence was 80% and participants' satisfaction had a mean (SD) of 4.57 (0.70) out of 5. The intervention group significantly improved on toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures increased over time; controls showed significantly increased heel peak pressures and force. The exercise program was feasible, based on a moderate recruitment rate and an adherent and satisfied population, and the intervention showed several positive preliminary effects over time compared to usual care.",2020,"For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05).","['30 people with', 'people with diabetic neuropathy (DPN', 'people at risk of diabetic foot disease', 'People with Diabetic Neuropathy', '45 eligible participants (0.90/week']","['foot-ankle exercise program', 'DPN to usual care (control) or usual care plus a supervised exercise program (intervention', 'Foot-ankle strengthening and mobility exercises', 'Foot-Ankle Exercise Program']","['daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests', 'Program adherence', 'heel peak pressures and force', 'recruitment rate and participant adherence and satisfaction', 'clinical, functional and biomechanical outcomes', 'toes strength, contact time during gait and DPN symptoms, and peak forefoot pressures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0576183', 'cui_str': 'Ankle joint - range of movement'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}]",45.0,0.0840922,"For program efficacy, we assessed baseline to 12-week changes in daily physical activity level, gait speed, tactile sensitivity, ankle range of motion, DPN symptoms, quality of life, foot health and functionality, foot strength and plantar pressure during gait, using paired t-tests ( p  < 0.05).","[{'ForeName': 'Renan L', 'Initials': 'RL', 'LastName': 'Monteiro', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Jane S S P', 'Initials': 'JSSP', 'LastName': 'Ferreira', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Érica Q', 'Initials': 'ÉQ', 'LastName': 'Silva', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Donini', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Ronaldo H', 'Initials': 'RH', 'LastName': 'Cruvinel-Júnior', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Jady L', 'Initials': 'JL', 'LastName': 'Verissímo', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}, {'ForeName': 'Sicco A', 'Initials': 'SA', 'LastName': 'Bus', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Rehabilitation Medicine, Amsterdam Movement Sciences, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional da Faculdade de Medicina da Universidade de São Paulo, Rua Cipotânea, 51 - Butantã, São Paulo, SP 05360-000, Brazil.'}]","Sensors (Basel, Switzerland)",['10.3390/s20185129']
2798,32916855,The Potential Influence of Group Membership on Outcomes in Indicated Cognitive-Behavioral Adolescent Depression Prevention.,"BACKGROUND


Adolescent depression prevention programs are typically delivered in groups in which adolescents share a common setting and interventionist, but the influence of the group is usually ignored or statistically controlled. We tested whether the primary outcomes of reductions in depressive symptoms and future onset of major depressive disorder (MDD) varied as a function of group membership.
METHODS


Data were available from two randomized trials in which 220 adolescents received the Blues Program indicated prevention intervention in 36 separate groups; participants were assessed at baseline, post intervention, and at 6-, 12-, and 24-month follow-ups.
RESULTS


Ten percent of participants had developed MDD 2 years post intervention. Group-level effects for MDD onset over follow-up were nonsignificant (accounted for <1% of variance; ICC = 0.004, ns). Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05). Group-level clustering of posttest depressive symptoms was not associated with size of group or gender composition.
CONCLUSIONS


Membership in specific adolescent cognitive-behavioral depression prevention groups may have an impact in terms of immediate symptom reduction but does not appear to have significant prevention effects in terms of long-term symptom change or MDD onset.",2020,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).",['Data were available from two randomized trials in which 220 adolescents received the'],"['Blues Program indicated prevention intervention', 'Group Membership']","['depressive symptoms and future onset of major depressive disorder (MDD', 'depressive symptom change']","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",220.0,0.127502,"Group-level effects for depressive symptom change across the follow-up period were also nonsignificant (ICC = 0.001, ns) but group effects accounted for 16% of depressive symptom change immediately post intervention (ICC = 0.159,  p  < 0.05).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}, {'ForeName': 'Frédéric N', 'Initials': 'FN', 'LastName': 'Brière', 'Affiliation': 'École de Psychoéducation, Université de Montréal, Montreal, QC H3T 1J4, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences), Stanford University Medical Center, Stanford, CA 94305, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186553']
2799,32916983,Telemonitoring in Chronic Pain Management Using Smartphone Apps: A Randomized Controlled Trial Comparing Usual Assessment against App-Based Monitoring with and without Clinical Alarms.,"BACKGROUND


The usefulness of mHealth in helping to target face-to-face interventions for chronic pain more effectively remains unclear. In the present study, we aim to test whether the Pain Monitor mobile phone application (app) is well accepted by clinicians, and can help improve existent medical treatments for patients with chronic musculoskeletal pain. Regarding this last goal, we compared three treatment conditions, namely usual treatment, usual treatment with an app without alarms and usual treatment with an app with alarms. All treatments lasted one month. The three treatments were compared for all outcomes, i.e., pain severity and interference, fatigue, depressed mood, anxiety and anger.
METHODS


In this randomized controlled trial, the usual monitoring method (i.e., onsite;  n  = 44) was compared with daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms ( n  = 45). Alarms were sent to the clinicians in the presence of pre-established undesired clinical events and could be used to make treatment adjustments throughout the one-month study.
RESULTS


With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups). The clinicians were willing to use the app, especially the version with alarms.
CONCLUSIONS


The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.",2020,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).",['patients with chronic musculoskeletal pain'],"['daily ecological momentary assessment using the Pain Monitor app-both with ( n  = 43) and without alarms', 'Pain Monitor mobile phone application (app', 'Telemonitoring', 'usual treatment with an app without alarms and usual treatment with an app with alarms']","['pain severity and interference, fatigue, depressed mood, anxiety and anger']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0336648', 'cui_str': 'Alarm'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",,0.0691226,"With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Department of Personality, Assessment, and Psychological Treatments, Universidad de Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragozá', 'Affiliation': 'Ciber Fisiopatologia Obesidad y Nutricion (CB06/03 Instituto Salud Carlos III) (Ciber Physiopathology Obesity and Nutrition, CB06/03 Instituto Salud Carlos III Health Institute), 28029 Madrid, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Mesas', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Server', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Medel', 'Affiliation': ""Pain Clinic, Vall d'Hebron Hospital, 08035 Barcelona, Spain.""}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17186568']
2800,31081565,Associations of atopic dermatitis and asthma with child behaviour: Results from the PROBIT cohort.,"BACKGROUND


Conflicting findings from studies evaluating associations of allergic disease with child behaviour require longitudinal studies to resolve.
OBJECTIVE


To estimate the magnitude of associations of atopic dermatitis (AD) in infancy, and symptoms of asthma and AD at 6.5 years, with child behaviour at 6.5 years.
METHODS


Secondary cohort analysis of the Promotion of Breastfeeding Intervention Trial (PROBIT). PROBIT enrolled 17 046 infants at birth and followed them up at 6.5 years (n = 13 889). Study paediatricians collected data on infantile AD at repeated follow-up examinations during the first year of life. At 6.5 years, paediatricians performed skin prick tests and parents reported asthma and AD symptoms during the prior year. In addition, parents and teachers completed the Strength and Difficulties Questionnaire, which includes scales on hyperactivity/inattention, emotional problems, conduct problems, peer problems and prosocial behaviours.
RESULTS


Physician-diagnosed AD in the first year of life was not associated with increased risk for behavioural problems at 6.5 years. Emotional problems at 6.5 years were more common among children with AD symptoms (OR: 2.24, 95% CI: 1.62-3.12) and asthma symptoms (OR: 1.45; 95% CI: 1.07-1.96) during the past year at 6.5 years and ORs for children with symptoms of more severe AD and asthma were also higher. AD in the past year was also associated with probable hyperactivity/inattention disorder at 6.5 years (OR: 2.05; 95% CI: 1.09-3.84). Other subscales of the SDQ were not related to asthma or AD symptoms during the past year.
CONCLUSIONS AND CLINICAL RELEVANCE


Children with AD symptoms were at higher risk for concomitant hyperactivity/inattention and emotional disorder, and children with asthma symptoms were at higher risk of having concomitant emotional problems. However, AD during infancy did not predict childhood behaviours.",2019,"Emotional problems at 6.5 years were more common among children with AD symptoms (OR: 2.24, 95% CI: 1.62-3.12) and asthma symptoms (OR: 1.45; 95% CI: 1.07-1.96) during the past year at 6.5 years and ORs for children with symptoms of more severe AD and asthma were also higher.","['Children with AD symptoms', 'PROBIT enrolled 17\xa0046 infants at birth and followed them up at 6.5\xa0years (n\xa0=\xa013\xa0889', 'atopic dermatitis and asthma with child behaviour', 'atopic dermatitis (AD) in infancy, and symptoms of asthma and AD at 6.5\xa0years, with child behaviour at 6.5\xa0years']",[],"['Emotional problems', 'hyperactivity/inattention, emotional problems, conduct problems, peer problems and prosocial behaviours', 'asthma symptoms', 'asthma and AD symptoms', 'probable hyperactivity/inattention disorder', 'risk for behavioural problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3844007', 'cui_str': '6.5'}]",[],"[{'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3532917', 'cui_str': 'Peer problem'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",17046.0,0.11034,"Emotional problems at 6.5 years were more common among children with AD symptoms (OR: 2.24, 95% CI: 1.62-3.12) and asthma symptoms (OR: 1.45; 95% CI: 1.07-1.96) during the past year at 6.5 years and ORs for children with symptoms of more severe AD and asthma were also higher.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Ballardini', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Alexander John', 'Initials': 'AJ', 'LastName': 'Henderson', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bogdanovich', 'Affiliation': 'National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus.'}, {'ForeName': 'Mourad', 'Initials': 'M', 'LastName': 'Dahhou', 'Affiliation': 'Departments of Pediatrics and of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vilchuck', 'Affiliation': 'National Research and Applied Medicine Mother and Child Centre, Minsk, Belarus.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Departments of Pediatrics and of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Flohr', 'Affiliation': ""St John's Institute of Dermatology, Guy's and St Thomas' Hospital, NHS Foundation Trust and King's College London, London, UK.""}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13417']
2801,31187518,DNA methylation is associated with inhaled corticosteroid response in persistent childhood asthmatics.,"BACKGROUND


Response to inhaled corticosteroids is highly variable, and the association between DNA methylation and treatment response is not known.
OBJECTIVE


To examine the association between peripheral blood DNA methylation and inhaled corticosteroid response in children with persistent asthma.
METHODS


Epigenome-wide DNA methylation was analysed in individuals on inhaled corticosteroids in three independent and ethnically diverse cohorts-Childhood Asthma Management Program (CAMP); Children, Allergy, Milieu, Stockholm, Epidemiology (BAMSE); and Genetic Epidemiology of Asthma in Costa Rica Study (GACRS). Treatment response was evaluated using two definitions, the absence of emergency department visits and/or hospitalizations and the absence oral corticosteroid use while on inhaled corticosteroid therapy. CpG sites meeting nominal significance (P < 0.05) for each outcome were combined in a three-cohort meta-analysis with adjustment for multiple testing. DNA methylation was correlated with gene expression using Pearson and partial correlations.
RESULTS


In 154 subjects from CAMP, 72 from BAMSE, and 168 from GACRS, relative hypomethylation of cg00066816 (171 bases upstream of IL12B) was associated with the absence of emergency department visits and/or hospitalizations (Q = 0.03) in all cohorts and lower IL12B expression (ρ = 0.34, P = 0.01) in BAMSE. Relative hypermethylation of cg04256470 (688 bases upstream of CORT) was associated with the absence of oral corticosteroid use (Q = 0.04) in all cohorts and higher CORT expression (ρ = 0.20, P = 0.045) in CAMP.
CONCLUSION AND CLINICAL RELEVANCE


Differential DNA methylation of IL12B and CORT are associated with inhaled corticosteroid treatment response in persistent childhood asthmatics. Pharmaco-methylation can identify novel markers of treatment sensitivity in asthma.",2019,"CONCLUSION AND CLINICAL RELEVANCE


Differential DNA methylation of IL12B and CORT are associated with inhaled corticosteroid treatment response in persistent childhood asthmatics.","['154 subjects from CAMP, 72 from BAMSE, and 168 from GACRS, relative hypomethylation of cg00066816 (171 bases upstream of IL12B', 'Epigenome-wide DNA methylation was analysed in individuals on inhaled corticosteroids in three independent and ethnically diverse cohorts-Childhood Asthma Management Program (CAMP); Children, Allergy, Milieu, Stockholm, Epidemiology (BAMSE); and Genetic Epidemiology of Asthma in Costa Rica Study (GACRS', 'children with persistent asthma']",[],"['CORT expression', 'IL12B expression ']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0872180', 'cui_str': 'Genetic Epidemiology'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0010182', 'cui_str': 'Costa Rica'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}, {'cui': 'C4727083', 'cui_str': 'Methylome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}]",[],"[{'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1099914', 'cui_str': 'IL12B protein, human'}]",,0.0669843,"CONCLUSION AND CLINICAL RELEVANCE


Differential DNA methylation of IL12B and CORT are associated with inhaled corticosteroid treatment response in persistent childhood asthmatics.","[{'ForeName': 'Alberta L', 'Initials': 'AL', 'LastName': 'Wang', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Olena', 'Initials': 'O', 'LastName': 'Gruzieva', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Weiliang', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kebede Merid', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Celedón', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Children's Hospital of Pittsburgh of UPMC, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Raby', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Cilla', 'Initials': 'C', 'LastName': 'Söderhäll', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'DeMeo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Melén', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kelan G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13447']
2802,31776293,Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis.,"Nonalcoholic steatohepatitis (NASH) is characterized by the accumulation of hepatocyte triglycerides, the synthesis of which is catalyzed by diacylglycerol acyltransferases (DGATs). Here, we investigate DGAT2 as a potential therapeutic target using an orally administered, selective DGAT2 inhibitor, PF-06427878. Treatment with PF-06427878 resulted in the reduction of hepatic and circulating plasma triglyceride concentrations and decreased lipogenic gene expression in rats maintained on a Western-type diet. In a mouse model of NASH, histological improvements in steatosis, ballooning, and fibrosis were evident in the livers of animals receiving PF-06427878 compared with mice treated with vehicle alone. We extended these nonclinical studies to two phase 1 studies in humans [NCT02855177 ( n  = 24) and NCT02391623 ( n  = 39;  n  = 38 completed)] and observed that PF-06427878 was well tolerated and influenced markers of liver function (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total bilirubin) in healthy adults, with statistically significant reductions from baseline at day 14 in participants treated with PF-06427878 1500 milligrams per day ( P  < 0.05). Moreover, magnetic resonance imaging using proton density fat fraction showed that PF-06427878 1500 milligrams per day reduced hepatic steatosis in healthy adult participants. Our findings highlight DGAT2 inhibition by a small, potent, selective compound as a potential therapeutic approach for the treatment of NASH.",2019,Treatment with PF-06427878 resulted in the reduction of hepatic and circulating plasma triglyceride concentrations and decreased lipogenic gene expression in rats maintained on a Western-type diet.,['healthy adult participants'],['Nonalcoholic steatohepatitis (NASH'],"['tolerated and influenced markers of liver function (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total bilirubin', 'reduction of hepatic and circulating plasma triglyceride concentrations', 'hepatic steatosis', 'lipogenic gene expression', 'steatosis, ballooning, and fibrosis']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0583329', 'cui_str': 'Plasma triglyceride measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}]",,0.0610785,Treatment with PF-06427878 resulted in the reduction of hepatic and circulating plasma triglyceride concentrations and decreased lipogenic gene expression in rats maintained on a Western-type diet.,"[{'ForeName': 'Neeta B', 'Initials': 'NB', 'LastName': 'Amin', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA. neeta.amin@pfizer.com.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Carvajal-Gonzalez', 'Affiliation': 'Early Clinical Development, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Purkal', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Early Clinical Development, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Crowley', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Perez', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Chidsey', 'Affiliation': 'Early Clinical Development, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Albert M', 'Initials': 'AM', 'LastName': 'Kim', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goodwin', 'Affiliation': 'Internal Medicine Research Unit, Pfizer Worldwide Research and Development, Cambridge, MA 02139, USA.'}]",Science translational medicine,['10.1126/scitranslmed.aav9701']
2803,32916985,Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial.,"Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV 1 ). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI) .  We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)-an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions; or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.",2020,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).",['Male firefighters with WTC-LI and a BMI > 27 kg/m 2  will be included'],"['Protocol', 'calorie-restricted Mediterranean dietary intervention', 'Low Calorie Mediterranean ']","['reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary', 'metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0034072', 'cui_str': 'Cor pulmonale'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0628545,"Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV 1 , fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary).","[{'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Kwon', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Riggs', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Crowley', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Isabel R', 'Initials': 'IR', 'LastName': 'Young', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Nayar', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sunseri', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Mena', 'Initials': 'M', 'LastName': 'Mikhail', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Ostrofsky', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Arul', 'Initials': 'A', 'LastName': 'Veerappan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Zeig-Owens', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Schwartz', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Colbeth', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mengling', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Population Health, Division of Biostatistics, New York University School of Medicine, New York, NY 10016, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Pompeii', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'St-Jules', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Prezant', 'Affiliation': 'Bureau of Health Services and Office of Medical Affairs, Fire Department of New York, Brooklyn, NY 11201, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'Department of Population Health, Division of Health and Behavior, Center for Healthful Behavior Change, School of Medicine, New York University, New York, NY 10016, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nolan', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, New York University, New York, NY 10016, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17186569']
2804,32917039,The Retentive Strength of Zirconium Oxide Crowns Cemented by Self-Adhesive Resin Cements before and after 6 Months of Aging.,"The aim of this study was to evaluate the retentive strength of zirconium oxide (yttria-stabilized tetragonal zirconia polycrystals (Y-TZP)) crown-copings treated by combined mechanical and chemical treatments and cemented by four types of self-adhesive resin cements (SARCs) to human prepared teeth, before and after six months of aging in water and thermocycling. A total of 120 molar teeth were mounted, prepared using a standardized protocol and digitally scanned, and Y-TZP copings were produced. Teeth were randomly assigned to four SARC groups. Prior to cementation, the intaglio surfaces of all crowns were sandblasted and then coated with Z-Prime™ Plus (Bisco Dental, Schaumburg, IL, USA). Post cementation, each cement group was subdivided into aged and non-aged groups. After aging, the cemented assemblies were tested for retentive strength using a universal testing machine. Failure analysis was conducted by inspecting all matched debonded surfaces of the teeth and crowns at 3× magnification. Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918). The interaction between cement and aging was statistically significant ( p  = 0.024). No significant differences in the retentive strengths between the different SARCs were observed pre-aging ( p  = 0.776), whereas post-aging, Panavia SA (PAN; Kuraray Dental Co Ltd., Osaka, Japan) showed significantly higher strength than RelyX U-200 (RU200; 3M ESPE, Seefeld, Germany). The predominant failure mode was adhesive between the cement and dentin, followed by mixed mode failure.",2020,Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918).,['A total of 120 molar teeth'],['zirconium oxide (yttria-stabilized tetragonal zirconia polycrystals (Y-TZP'],"['Retentive Strength', 'retentive strength', 'retentive strengths']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C1567733', 'cui_str': 'yttria stabilized tetragonal zirconia'}]",[],120.0,0.024198,Aging treatment did not affect the retentive strength of the Y-TZP crown-copings ( p  = 0.918).,"[{'ForeName': 'Shifra', 'Initials': 'S', 'LastName': 'Levartovsky', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Lilac', 'Initials': 'L', 'LastName': 'Cartier', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Brand', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Jaron John', 'Initials': 'JJ', 'LastName': 'Blasbalg', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Pilo', 'Affiliation': 'Department of Oral Rehabilitation, The Maurice and Gabriela Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv 6997801, Israel.'}]","Materials (Basel, Switzerland)",['10.3390/ma13183998']
2805,32903368,Feasibility and Efficacy of a Psychological Therapy for Patients With a Schizophrenic Psychosis in an Inpatient Setting: Study Protocol of a Randomized Switch Controlled Trial.,"Background:  Schizophrenic psychoses are severe mental disorders. Despite advances in treatment, outcomes are still unsatisfactory. Pharmacological treatments are still limited, in particular regarding improvements in psychosocial functioning and neuro-cognitive impairment. In recent years new psychological therapies have been developed, demonstrating promising results. However, most of these interventions have been designed for and studied in outpatients; their efficacy and feasibility for patients requiring hospitalization is still unknown. Therefore, we have designed a clinical trial to compare a neuro-cognitive (Integrated Neuro-cognitive Treatment INT); a cognitive-behavioral (Integrated Psychological Therapy IPT); and a control (Cogpack CGP) intervention for patients with a schizophrenic psychosis hospitalized for treatment.  Methods:  In a three-parallel-arm, single-blind, randomized, controlled study, we compare INT, IPT, and CGP. Participants will take part in two weekly sessions of one intervention for at least 16 sessions. If due to randomization, participants are allocated to a treatment arm not suitable for them, they are allowed to switch intervention after four sessions. Based on a sample size calculation, recruitment will continue until 30 participants have completed the intervention for each treatment arm.  Outcome Measurement:  Primary outcomes are: change in symptom as measured by the Positive and Negative Syndrome Scale (PANSS), change in psychosocial functioning as assessed by the mini ICF-APP and neuro-cognitive performance, assessed by the Matrics Cognitive Consensus Battery (MCCB). Other outcomes of interest are the Brief Symptom Inventory (BSI) and the Health of the Nation Outcome Scales (HoNOS); together with prescribed medication, treatment retention and completion rates. Outcomes will be measured at baseline, 2 weeks into treatment (prior to a potential switch of intervention arm), post-treatment and at 6 and 12-month post-treatment follow-ups.  Expected Outcomes:  We expect an overall improvement; however, with differences in specific domains for each treatment arm, with those completing INT showing better outcomes than IPT and CGP, respectively. We anticipate that lower functioning participants will drift to CGP and higher functioning participants to INT.  Conclusion:  Due to the complexity of treatment for patients with a schizophrenic psychosis, we consider it crucial to compare different treatment options for those more severely affected, therefore, requiring inpatient treatment.  Trial registration:  www.clinicaltrials.gov (ID: NCT03316664; 17.10.2017).",2020,"Primary outcomes are: change in symptom as measured by the Positive and Negative Syndrome Scale (PANSS), change in psychosocial functioning as assessed by the mini ICF-APP and neuro-cognitive performance, assessed by the Matrics Cognitive Consensus Battery (MCCB).","['patients with a schizophrenic psychosis hospitalized for treatment', 'Patients With a Schizophrenic Psychosis in an Inpatient Setting', 'patients with a schizophrenic psychosis']","['cognitive-behavioral (Integrated Psychological Therapy IPT', 'control (Cogpack CGP) intervention', 'neuro-cognitive (Integrated Neuro-cognitive Treatment INT', 'Psychological Therapy']","['change in symptom as measured by the Positive and Negative Syndrome Scale (PANSS), change in psychosocial functioning as assessed by the mini ICF-APP and neuro-cognitive performance, assessed by the Matrics Cognitive Consensus Battery (MCCB', 'Feasibility and Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0848257', 'cui_str': 'Schizophrenic psychoses'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0808763,"Primary outcomes are: change in symptom as measured by the Positive and Negative Syndrome Scale (PANSS), change in psychosocial functioning as assessed by the mini ICF-APP and neuro-cognitive performance, assessed by the Matrics Cognitive Consensus Battery (MCCB).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Redlich Bossy', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, Psychiatric University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mueller', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, Psychiatric University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Vetter', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, Psychiatric University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stephan T', 'Initials': 'ST', 'LastName': 'Egger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, Psychiatric University Hospital of Zurich, University of Zurich, Zurich, Switzerland.'}]",Frontiers in public health,['10.3389/fpubh.2020.00391']
2806,32903373,"Effects of Installing Height-Adjustable Standing Desks on Daily and Domain-Specific Duration of Standing, Sitting, and Stepping in 3rd Grade Primary School Children.","Background:  Aim of this intervention study was to evaluate whether availability of standing desks in classrooms may reduce sitting time and enhance standing and stepping time during lessons and breaks. Further, we evaluated if differences in standing desk use differed by physical fitness (PF) levels of children.  Methods:  To assess sitting, standing and stepping during a typical school week in 3rd grade primary school children ( N  = 52), activPAL monitors were used at baseline: T0, 1st follow-up: T1 and 2nd follow-up: T2. At baseline, PF was measured using the standing long jump and the 6-min jog-walk to assign children as having low PF (LPF) or high PF (HPF). Standing desks were assigned randomly to intervention and control groups at T1 (group 1) and T2 (group 2) with a cross-over design. Changes of sitting, standing and stepping were analyzed to investigate intervention effects at follow-up, using linear mixed models.  Results:  At baseline, children spent about 60 and 30% of time sitting during lessons and breaks, respectively. After installing standing desks (T1), significantly lower proportions of sitting were observed in the intervention group 1 [-13.1%, 95%-CI: (-20.5; -5.72)] and the control group 2 [-9.78%, 95%-CI: (-17.3; -2.28)]. Compared to the baseline measurement (T0), lower proportions of sitting were particularly expressed during school breaks in group 1 and 2 after intervention in T1 [group 1: -10.3%, 95%-CI: (-16.4; -4.25)] or in T2 [group 2: -8.59%, 95%-CI: (-15.2; -1.94)]. In general, children with higher physical fitness were less sedentary and more active, but intervention effects did not differ by fitness levels.  Conclusion:  Standing desks provide an opportunity to reduce sedentary time during lessons and breaks at school in primary school children, but do not directly increase PA of high intensity such as stepping. Future studies should consider potential bandwagon effects caused by structural interventions.",2020,"Compared to the baseline measurement (T0), lower proportions of sitting were particularly expressed during school breaks in group 1 and 2 after intervention in T1 [group 1: -10.3%, 95%-CI: (-16.4; -4.25)] or in T2 [group 2: -8.59%, 95%-CI: (-15.2; -1.94)].","['3rd Grade Primary School Children', '3rd grade primary school children ( N  = 52), activPAL monitors', 'primary school children']",['Installing Height-Adjustable Standing Desks'],"['proportions of sitting', 'Changes of sitting, standing and stepping', 'physical fitness (PF) levels of children', 'Daily and Domain-Specific Duration of Standing, Sitting, and Stepping', 'sitting time and enhance standing and stepping time']","[{'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.057807,"Compared to the baseline measurement (T0), lower proportions of sitting were particularly expressed during school breaks in group 1 and 2 after intervention in T1 [group 1: -10.3%, 95%-CI: (-16.4; -4.25)] or in T2 [group 2: -8.59%, 95%-CI: (-15.2; -1.94)].","[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Sprengeler', 'Affiliation': 'Department of Epidemiological Methods and Etiologic Research, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Hebestreit', 'Affiliation': 'Department of Epidemiological Methods and Etiologic Research, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Gohres', 'Affiliation': 'School of Public Health, Bielefeld University, Bielefeld, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bucksch', 'Affiliation': 'Department of Sociological and Human Sciences, Heidelberg University of Education, Heidelberg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Buck', 'Affiliation': 'Department of Biometry and Data Management, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.'}]",Frontiers in public health,['10.3389/fpubh.2020.00396']
2807,32903394,"The Effects of Dance Movement Therapy in the Treatment of Depression: A Multicenter, Randomized Controlled Trial in Finland.","This multicenter research investigates the effects of dance movement therapy (DMT) on participants diagnosed with depression. In total, 109 persons participated in the study in various locations in Finland. The participants were 39 years old, on average (range = 18-64 years), and most were female (96%). All participants received treatment as usual (TAU). They were randomized into DMT + TAU ( n  = 52) or TAU only ( n  = 57). The participants in the DMT + TAU group were offered 20 DMT sessions twice a week for 10 weeks in addition to standard care. The measurement points included pretreatment measurement at the baseline, posttreatment measurement at the end of the intervention, and a follow-up measurement 3 months afterward. The observed effects of the intervention among participants in the DMT+TAU group were a greater reduction in depression and in indicators of physical and psychological distress in comparison to the participants who received TAU-only. At the 3-month follow-up, the corrected between-group effect sizes (ESs) were medium and in favor of the DMT + TAU group ( d  = 0.60-0.72). These results are in line with the increasing number of research studies showing the benefits of DMT intervention among participants with depression, and these results indicate that DMT may improve the effectiveness of standard care.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier NCT04421651.",2020,The observed effects of the intervention among participants in the DMT+TAU group were a greater reduction in depression and in indicators of physical and psychological distress in comparison to the participants who received TAU-only.,"['Depression', 'participants diagnosed with depression', 'participants were 39 years old, on average (range = 18-64 years), and most were female (96', 'participants with depression', '109 persons participated in the study in various locations in Finland']","['Dance Movement Therapy', 'DMT', 'DMT + TAU', 'DMT intervention', 'TAU', 'dance movement therapy (DMT']",['depression and in indicators of physical and psychological distress'],"[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",109.0,0.0523845,The observed effects of the intervention among participants in the DMT+TAU group were a greater reduction in depression and in indicators of physical and psychological distress in comparison to the participants who received TAU-only.,"[{'ForeName': 'Katriina', 'Initials': 'K', 'LastName': 'Hyvönen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Pylvänäinen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Joona', 'Initials': 'J', 'LastName': 'Muotka', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Raimo', 'Initials': 'R', 'LastName': 'Lappalainen', 'Affiliation': 'Department of Psychology, University of Jyväskylä, Jyväskylä, Finland.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01687']
2808,32903452,Reducing Aggression and Improving Physical Fitness in Adolescents Through an After-School Volleyball Program.,"This study aimed to determine the effects of an after-school volleyball program on aggression and physical fitness in 14-16 years old students. One hundred and seven participants were randomized to a small-sided volleyball (SSV) training group or a control group (CON). The SSV group completed 8 months of small-sided volleyball training twice a week after school in addition to the regular physical education classes. Yo-Yo Intermittent Recovery Level 1 test (YYIRT1), medicine ball throw (MED), vertical jump (VJ), and Buss and Perry's aggression questionnaire were evaluated before and after 8 months of training. Results revealed a significant interaction effect (group × time) in total sample for physical aggression [ F (1, 105) = 17.688;  p  < 0.001], verbal aggression [ F (1, 105) = 4.973;  p  = 0.028], anger [ F (1, 105) = 7.662;  p  = 0.007], medicine ball throw [ F (1, 105) = 36.143;  p  < 0.001], and YYIRT1 [ F (1, 105) = 12.508;  p  = 0.001]. After-school small-sided volleyball for adolescents was accompanied by a significant decrease in aggression compared to physical education classes only. Additionally, adolescents from SSV group showed better results in physical fitness compared to the control group. Our findings significantly contribute to the understanding of possible mechanisms for reducing adolescents' aggression, which include enjoyment, motivation, and self-control through sport intervention.",2020,After-school small-sided volleyball for adolescents was accompanied by a significant decrease in aggression compared to physical education classes only.,"['One hundred and seven participants', '14-16 years old students', 'Adolescents Through an After-School Volleyball Program']","['small-sided volleyball (SSV) training group or a control group (CON', 'school volleyball program']","['verbal aggression', ""Yo-Yo Intermittent Recovery Level 1 test (YYIRT1), medicine ball throw (MED), vertical jump (VJ), and Buss and Perry's aggression questionnaire"", 'physical fitness', 'aggression and physical fitness', 'aggression', 'Reducing Aggression and Improving Physical Fitness']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424322', 'cui_str': 'Verbal aggression'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",107.0,0.0164899,After-school small-sided volleyball for adolescents was accompanied by a significant decrease in aggression compared to physical education classes only.,"[{'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Sporiš', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Petrinović', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.02081']
2809,32904023,Ex Situ Arterial Reconstruction During Normothermic Perfusion of the Liver.,"Background


Aberrant hepatic arterial anatomy may be seen in up to 30% of liver grafts, and reconstruction prolongs the cold ischemic time or the arterialization times. If normothermic machine preservation (NMP) is used to preserve liver grafts, the presence of aberrant arterial anatomy poses a challenge. Dual arterial cannulation is a temporary solution to enable effective perfusion, until optimal circumstances are met for arterial reconstruction, without compromising ischemia time. To date the technical and logistical feasibility of arterial reconstruction ex situ and  during  NMP has not been reported.
Methods


Series of 5 cases from the Consortium for Organ Preservation in Europe randomized controlled trial in which grafts with arterial anatomic variations were reconstructed while organs were perfused on NMP.
Results


One donor after cardiac death and 4 donor after brain death livers with arterial anatomical variations reconstructed while on NMP were included. All patients survived transplantation, spending 1-7 d in intensive care unit and discharged home after 5-15 d. None of the cases developed early allograft dysfunction or any early technical complications. At follow-up, there were no late hepatic artery thrombosis, stenosis, or any other vascular-related complication. Four of 5 patients underwent magnetic resonance cholangiopancreatography at 6 mo with no evidence of ischemic cholangiopathy.
Conclusions


The case series described above suggests that ex vivo arterial reconstruction surgery on liver grafts while on board the NMP device is feasible, safe, and effective.",2020,"At follow-up, there were no late hepatic artery thrombosis, stenosis, or any other vascular-related complication.",[],"['normothermic machine preservation (NMP', 'magnetic resonance cholangiopancreatography', 'Dual arterial cannulation']","['late hepatic artery thrombosis, stenosis, or any other vascular-related complication', 'early allograft dysfunction or any early technical complications']",[],"[{'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0994163', 'cui_str': 'Magnetic resonance cholangiopancreatography'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0392106', 'cui_str': 'Hepatic artery thrombosis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",,0.031416,"At follow-up, there were no late hepatic artery thrombosis, stenosis, or any other vascular-related complication.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nasralla', 'Affiliation': 'Liver Centre, Royal Free Hospital London, London, United Kingdom.'}, {'ForeName': 'Hanns', 'Initials': 'H', 'LastName': 'Lembach', 'Affiliation': 'The Liver Unit, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Hynek', 'Initials': 'H', 'LastName': 'Mergental', 'Affiliation': 'The Liver Unit, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Mirza', 'Affiliation': 'The Liver Unit, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Friend', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Muiesan', 'Affiliation': 'The Liver Unit, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Mtpr', 'Initials': 'M', 'LastName': 'Perera', 'Affiliation': 'The Liver Unit, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.'}]",Transplantation direct,['10.1097/TXD.0000000000001040']
2810,32904078,Intraoral Dual Wavelength Laser Diode Therapy for Chronic Maxillary Sinusitis.,"Background


Chronic sinusitis is one of the most common chronic diseases involving different age groups. The different etiological factors and difficult diagnostic procedures contribute to misdiagnosis and chronicity of sinusitis. There is no standard treatment for sinusitis. Long term use of corticosteroids and antibiotics may lead to numerous adverse side effects. Laser therapy has been suggested as a non-invasive treatment for sinusitis. It has anti-inflammatory and antibacterial effects. When considering maxillary sinusitis, discharge tends to collect in the sinus base due to its anatomy and altered physiology. To improve penetration of laser into the maxillary sinus, intraoral laser at the vestibule depth of the maxilla may be more effective.
Material and Subject


Thirty-four patients with chronic maxillary sinusitis were assigned into two groups. All were assessed before and after treatment. Group A received laser radiation plus standard medical treatment and group B received medical treatment only. The treatment plan was performed in 12 sessions using a Diode laser with a wavelength of 810 nm and 980nm. The SNOT-22 questionnaire and Computed Tomography were used to evaluate patients. A p-value < 0.05 was considered statistically significant.
Results


Both groups showed a significant improvement in symptoms following treatment (p < .001), however, the laser therapy group demonstrated greater improvements for all variables in response to treatment as compared to the traditional treatment group (p < .001).
Conclusions


Using high intensity intra-oral laser therapy with medical treatment is more effective than using medical treatment only for treatment of chronic maxillary sinusitis.",2020,"Both groups showed a significant improvement in symptoms following treatment (p < .001), however, the laser therapy group demonstrated greater improvements for all variables in response to treatment as compared to the traditional treatment group (p < .001).
","['Chronic Maxillary Sinusitis', 'chronic maxillary sinusitis', 'Material and Subject\n\n\nThirty-four patients with chronic maxillary sinusitis']","['Laser therapy', 'corticosteroids and antibiotics', 'Diode laser with a wavelength of 810 nm and 980nm', 'Intraoral Dual Wavelength Laser Diode Therapy', 'laser radiation plus standard medical treatment and group B received medical treatment only']",['symptoms'],"[{'cui': 'C0008698', 'cui_str': 'Chronic maxillary sinusitis'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",34.0,0.0143498,"Both groups showed a significant improvement in symptoms following treatment (p < .001), however, the laser therapy group demonstrated greater improvements for all variables in response to treatment as compared to the traditional treatment group (p < .001).
","[{'ForeName': 'Reham ALaa', 'Initials': 'RA', 'LastName': 'Elkalla', 'Affiliation': 'Assistant Lecturer of Physical Therapy for Surgery, School of Physical Therapy, Badr University in Cairo, Egypt.'}, {'ForeName': 'Adel Abdel Hamid', 'Initials': 'AAH', 'LastName': 'Nossier', 'Affiliation': 'Professor and Dean of Faculty of Physical Therapy, 6 October University, Egypt.'}, {'ForeName': 'Audrey Lynn', 'Initials': 'AL', 'LastName': 'Millar', 'Affiliation': 'Professor and Chair of Physical Therapy Department, School of Health Science, Winston Salem State University, United States of America.'}, {'ForeName': 'Mohamed Mahmoud', 'Initials': 'MM', 'LastName': 'El-Sheikh', 'Affiliation': 'Assistant Professor of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Helwan University, Egypt.'}, {'ForeName': 'Rania Abdelhady Ahmed', 'Initials': 'RAA', 'LastName': 'El Behairy', 'Affiliation': 'Assistant Professor of Oral and Maxillofacial Surgery, School of Oral and Dental Medicine, Badr University in Cairo, Egypt.'}, {'ForeName': 'Hussein Gamal Hussein', 'Initials': 'HGH', 'LastName': 'Mogahed', 'Affiliation': 'Lecturer of Physical Therapy for Surgery, Faculty of Physical Therapy, Cairo University, Egypt.'}]",Laser therapy,['10.5978/islsm.20-OR-06']
2811,32904114,Therapeutic effects of black seed oil supplementation on chronic obstructive pulmonary disease patients: A randomized controlled double blind clinical trial.,"This study sought to examine whether supplementation of Black Seed Oil (BSO) can improve pulmonary function tests (PFTs), inflammation, and oxidant-antioxidant markers in COPD patients. The study involved 100 patients of mild to moderate COPD divided randomly into 2 groups who were appointed to receive standard medication only ( control group ) or with additional Black Seed Oil ( BSO group ). They were assessed initially and after 3 months, 44 patients responded in control group and 47 patients in BSO group. BSO group evidenced a significant decreasing in oxidant and inflammatory markers; thiobarbituric acid reactive-substances (TBARS), protein carbonyl (PC) content, interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α), a significant increase in antioxidants; superoxide dismutase (SOD), catalase (CAT), reduced glutathione (GSH), glutathione peroxidase (GPx), vitamin C, and E, and a significant improvement in PFTs versus control group and baseline levels. Supplementation of Black Seed Oil may be an effective adjunct therapy to improve pulmonary functions, inflammation, and oxidant-antioxidant imbalance in COPD patients.",2020,"BSO group evidenced a significant decreasing in oxidant and inflammatory markers; thiobarbituric acid reactive-substances (TBARS), protein carbonyl (PC) content, interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α), a significant increase in antioxidants; superoxide dismutase (SOD), catalase (CAT), reduced glutathione (GSH), glutathione peroxidase (GPx), vitamin C, and E, and a significant improvement in PFTs versus control group and baseline levels.","['100 patients of mild to moderate COPD divided randomly into 2 groups who were appointed to receive', 'COPD patients', '44 patients responded in control group and 47 patients in BSO group', 'chronic obstructive pulmonary disease patients']","['standard medication only ( control group ) or with additional Black Seed Oil ( BSO group ', 'Black Seed Oil', 'BSO', 'black seed oil supplementation', 'Black Seed Oil (BSO']","['pulmonary function tests (PFTs), inflammation, and oxidant-antioxidant markers', 'pulmonary functions, inflammation, and oxidant-antioxidant imbalance', 'oxidant and inflammatory markers; thiobarbituric acid reactive-substances (TBARS), protein carbonyl (PC) content, interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', 'antioxidants; superoxide dismutase (SOD), catalase (CAT), reduced glutathione (GSH), glutathione peroxidase (GPx), vitamin C, and E, and a significant improvement in PFTs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",100.0,0.0906979,"BSO group evidenced a significant decreasing in oxidant and inflammatory markers; thiobarbituric acid reactive-substances (TBARS), protein carbonyl (PC) content, interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α), a significant increase in antioxidants; superoxide dismutase (SOD), catalase (CAT), reduced glutathione (GSH), glutathione peroxidase (GPx), vitamin C, and E, and a significant improvement in PFTs versus control group and baseline levels.","[{'ForeName': 'Mahmood A', 'Initials': 'MA', 'LastName': 'Al-Azzawi', 'Affiliation': 'Department of Medical Biochemistry, College of Dentistry, Al-Ayen University, An-Nasiriyah, Iraq.'}, {'ForeName': 'Mohamed M N', 'Initials': 'MMN', 'LastName': 'AboZaid', 'Affiliation': 'Department of Chest Diseases, Zagazig Faculty of Medicine, Zagazig University, Egypt.'}, {'ForeName': 'Reda Abdel Latif', 'Initials': 'RAL', 'LastName': 'Ibrahem', 'Affiliation': 'Department of Public Health and Community Medicine, Faculty of Medicine, Menoufia University, Egypt.'}, {'ForeName': 'Moustafa A', 'Initials': 'MA', 'LastName': 'Sakr', 'Affiliation': 'Molecular Diagnostics Department, Genetic Engineering and Biotechnology Research Institute (GEBRI), University of Sadat City, Sadat City, Egypt.'}]",Heliyon,['10.1016/j.heliyon.2020.e04711']
2812,32904121,"Effects of 12-week cadence retraining on impact peak, load rates and lower extremity biomechanics in running.","Background


Excessive impact peak forces and vertical load rates are associated with running injuries and have been targeted in gait retraining studies. This study aimed to determine the effects of 12-week cadence retraining on impact peak, vertical load rates and lower extremity biomechanics during running.
Methods


Twenty-four healthy male recreational runners were randomised into either a 12-week cadence retraining group ( n  = 12), which included those who ran with a 7.5% increase in preferred cadence, or a control group ( n  = 12), which included those who ran without any changes in cadence. Kinematics and ground reaction forces were recorded simultaneously to quantify impact force variables and lower extremity kinematics and kinetics.
Results


Significantly decreased impact peak (1.86 ± 0.30 BW vs. 1.67 ± 0.27 BW,  P  = 0.003), vertical average load rates (91.59 ± 18.91 BW/s vs. 77.31 ± 15.12 BW/s,  P  = 0.001) and vertical instantaneous load rates (108.8 ± 24.5 BW/s vs. 92.8 ± 18.5 BW/s,  P  = 0.001) were observed in the cadence retraining group, while no significant differences were observed in the control group. Foot angles (18.27° ± 5.59° vs. 13.74° ± 2.82°,  P  = 0.003) and vertical velocities of the centre of gravity (CoG) (0.706 ± 0.115 m/s vs. 0.652 ± 0.091 m/s,  P  = 0.002) significantly decreased in the cadence retraining group at initial contact, but not in the control group. In addition, vertical excursions of the CoG (0.077 ± 0.01 m vs. 0.069 ± 0.008 m,  P  = 0.002) and peak knee flexion angles (38.6° ± 5.0° vs. 36.5° ± 5.5°,  P  < 0.001) significantly decreased whilst lower extremity stiffness significantly increased (34.34 ± 7.08 kN/m vs. 38.61 ± 6.51 kN/m,  P  = 0.048) in the cadence retraining group. However, no significant differences were observed for those variables in the control group.
Conclusion


Twelve-week cadence retraining significantly increased the cadence of the cadence retraining group by 5.7%. This increased cadence effectively reduced impact peak and vertical average/instantaneous load rates. Given the close relationship between impact force variables and running injuries, increasing the cadence as a retraining method may potentially reduce the risk of impact-related running injuries.",2020,Twelve-week cadence retraining significantly increased the cadence of the cadence retraining group by 5.7%.,['Methods\n\n\nTwenty-four healthy male recreational runners'],"['cadence retraining group', 'cadence retraining']","['cadence of the cadence retraining', 'peak knee flexion angles', 'vertical instantaneous load rates', 'vertical velocities of the centre of gravity (CoG', 'extremity stiffness', 'Foot angles', 'vertical average load rates', 'Kinematics and ground reaction forces', 'impact peak, load rates and lower extremity biomechanics', 'impact peak, vertical load rates and lower extremity biomechanics']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",24.0,0.0365951,Twelve-week cadence retraining significantly increased the cadence of the cadence retraining group by 5.7%.,"[{'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Boyi', 'Initials': 'B', 'LastName': 'Dai', 'Affiliation': 'Division of Kinesiology and Health, University of Wyoming, Laramie, WY, USA.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}]",PeerJ,['10.7717/peerj.9813']
2813,32904341,Seeking neutral: A VR-based person-identity-matching task for attentional bias modification - A randomised controlled experiment.,"Background


Attentional bias modification (ABM) aims to reduce anxiety by attenuating bias towards threatening information. The current study incorporated virtual reality (VR) technology and 3-dimensional stimuli with a person-identity-matching (PIM) task to evaluate the effects of a VR-based ABM training on attentional bias and anxiety symptoms.
Methods


One hundred participants with elevated social anxiety were randomised to four training groups. Attentional bias was assessed at pre- and post-training, and anxiety symptoms were assessed at pre-training, post-training, 1-week follow-up, and 3-month follow-up.
Results


Change in anxiety did not correlate with change in bias ( r  = -0.08). A repeated-measures ANOVA showed no significant difference in bias from pre- to post-ABM, or between groups. For anxiety symptoms, a linear mixed-effects model analysis revealed a significant effect of time. Participants showed reduction in anxiety score at each successive assessment ( p  < .001, Nagelkerke's pseudo  r   2  = 0.65). However, no other significant main effect or interactions were found. A clinically significant change analysis revealed that 4% of participants were classified as 'recovered' at 3-month follow-up.
Conclusions


A single session of VR-based PIM task did not change attentional bias. The significant reduction in anxiety was not specific to active training, and the majority of participants remained clinically unchanged.",2020,"A repeated-measures ANOVA showed no significant difference in bias from pre- to post-ABM, or between groups.",['One hundred participants with elevated social anxiety'],"['Seeking neutral: A VR-based person-identity-matching task', 'virtual reality (VR) technology and 3-dimensional stimuli with a person-identity-matching (PIM) task', '\n\n\nAttentional bias modification (ABM', 'VR-based ABM training']","['attentional bias and anxiety symptoms', 'anxiety score', 'anxiety', 'Attentional bias']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",100.0,0.0544925,"A repeated-measures ANOVA showed no significant difference in bias from pre- to post-ABM, or between groups.","[{'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, Stockholm University, Frescativägen, 114 19 Stockholm, Sweden.'}, {'ForeName': 'Anne-Wil', 'Initials': 'AW', 'LastName': 'Kruijt', 'Affiliation': 'Department of Psychology, Stockholm University, Frescativägen, 114 19 Stockholm, Sweden.'}, {'ForeName': 'Anna-Karin', 'Initials': 'AK', 'LastName': 'Ek', 'Affiliation': 'Department of Psychology, Uppsala University, P.O. Box 256, 751 05 Uppsala, Sweden.'}, {'ForeName': 'Gustaf', 'Initials': 'G', 'LastName': 'Åbyhammar', 'Affiliation': 'Department of Psychology, Uppsala University, P.O. Box 256, 751 05 Uppsala, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Furmark', 'Affiliation': 'Department of Psychology, Uppsala University, P.O. Box 256, 751 05 Uppsala, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Solnavägen 1, 171 77 Solna, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Frescativägen, 114 19 Stockholm, Sweden.'}]",Internet interventions,['10.1016/j.invent.2020.100334']
2814,32904472,"Comparison of Low Dose versus High Dose of Oxytocin for Initiating Uterine Contraction During Cesarean Delivery: A Randomized, Controlled, Non-Inferiority Trial.","Background


Oxytocin is used for initiating uterine contraction and preventing postpartum hemorrhage during caesarean delivery. Using a lower dosage of oxytocin may lower the risk of adverse effects while still being effective in stimulating initial uterine contraction. We aimed to compare the effectiveness and side effects of the standard 10 IU bolus of oxytocin with those of a 5 IU bolus during caesarean delivery.
Patients and Methods


We enrolled women in a randomized, double-blind, study comparing intravenous injections of high-dose (10 IU) and low-dose (5 IU) oxytocin administered after clamping of the umbilical cord. The primary outcome was adequate uterine contraction within the first 3 mins after administration. Secondary outcomes included uterine tone, use of additional uterotonic agents, additional obstetrics procedures, and oxytocin-related adverse events.
Results


A total of 155 women underwent randomization, with 78 in the low-dose group and 77 in the high-dose group. The proportion of women with adequate uterine contraction during the first 3 mins was 84.6% in the low-dose group and 77.9% in the high-dose group (relative risk, 1.09; 95% CI, 0.93 to 1.26). Methylergonovine maleate was used in 14.1% of cases in the low-dose group and 36.4% in the high-dose group (relative risk, 0.40; 95% CI, 0.22 to 0.73). The necessity for additional obstetric procedures, estimated blood loss >500 mL, neonatal outcomes, and oxytocin-related adverse effects did not differ significantly between the two groups.
Conclusion


The 5 IU bolus of oxytocin was noninferior to the standard 10 IU bolus of oxytocin for initiating adequate uterine contraction, required fewer additional uterotonic agents, and led to fewer oxytocin-related adverse events.",2020,"Secondary outcomes included uterine tone, use of additional uterotonic agents, additional obstetrics procedures, and oxytocin-related adverse events.
","['155 women underwent randomization, with 78 in the low-dose group and 77 in the high-dose group']","['\n\n\nOxytocin', 'Methylergonovine maleate', 'Oxytocin', 'oxytocin']","['blood loss >500 mL, neonatal outcomes, and oxytocin-related adverse effects', 'Uterine Contraction', 'adequate uterine contraction', 'uterine tone, use of additional uterotonic agents, additional obstetrics procedures, and oxytocin-related adverse events', 'effectiveness and side effects', 'proportion of women with adequate uterine contraction', 'postpartum hemorrhage']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0289432', 'cui_str': 'Methylergonovine maleate'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0869904', 'cui_str': 'Obstetric procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",155.0,0.566322,"Secondary outcomes included uterine tone, use of additional uterotonic agents, additional obstetrics procedures, and oxytocin-related adverse events.
","[{'ForeName': 'Monsicha', 'Initials': 'M', 'LastName': 'Somjit', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Jaruta', 'Initials': 'J', 'LastName': 'Surojananon', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kiattisak', 'Initials': 'K', 'LastName': 'Kongwattanakul', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Cattleya', 'Initials': 'C', 'LastName': 'Kasemsiri', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Monthira', 'Initials': 'M', 'LastName': 'Sirisom', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Khuantipa', 'Initials': 'K', 'LastName': 'Prawannoa', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kaewjai', 'Initials': 'K', 'LastName': 'Thepsuthammarat', 'Affiliation': 'Clinical Epidemiology Unit, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Komwilaisak', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",International journal of women's health,['10.2147/IJWH.S260073']
2815,32904506,Variability of radiological grading of blunt cerebrovascular injuries in trauma patients.,"Context


Blunt cerebrovascular injury (BCVI) occurs in 1%-2% of all blunt trauma patients. Computed tomographic angiography of the neck (CTAn) is commonly used for the diagnosis and grading of BCVIs. Grade of injury dictates treatment, and there remains a lack in understanding the inter-reader reliability of these interpretations.
Aims


The aim of this study is to determine the extent of variability in BCVIs among specialized neuroradiologist interpretation of CTAn.
Settings and Design


Retrospective review of trauma patients admitted to a level one trauma center with a BCVI from January 2012 to December 2017. Patients were randomly assigned for CTAn re-evaluation by two of three blinded, neuroradiologists.
Statistical Analysis Used


The variability in BCVI grades was measured using the coefficient of unalikeability (u), and inter-reader reliability was calculated using weighted Cohen's kappa (k).
Results


Two hundred and twenty-eight BCVIs were analyzed with initial grades of 71 (31%) grade one, 74 (32%) grade two, 26 (11%) grade three, 57 (25%) grade four, and 0 grade five. Variability was present in 93 (41%) of all BCVIs. Grade one injuries had the lowest occurrence of total agreement (31%) followed by grade three (61%), grade two (63%), and grade four (92%). Total variability of grade interpretations (u = 100) occurred most frequently with grade three BCVIs (21%). Weighted Cohen's k calculations had a mean of 0.07, indicating poor reader agreement.
Conclusions


This novel study demonstrated the BCVI variability of radiological grade interpretation occurs in more than a third of patients. The reliability of CTAn interpretation of BCVI grades is not uniform, potentially leading to undertreatment and overtreatment.",2020,"Grade one injuries had the lowest occurrence of total agreement (31%) followed by grade three (61%), grade two (63%), and grade four (92%).","['trauma patients admitted to a level one trauma center with a BCVI from January 2012 to December 2017', 'trauma patients', 'Two hundred and twenty-eight BCVIs were analyzed with initial grades of 71 (31%) grade one, 74', 'blunt trauma patients']",['Computed tomographic angiography of the neck (CTAn'],"['coefficient of unalikeability (u), and inter-reader reliability', 'Total variability of grade interpretations', 'Variability']","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}]",228.0,0.0516591,"Grade one injuries had the lowest occurrence of total agreement (31%) followed by grade three (61%), grade two (63%), and grade four (92%).","[{'ForeName': 'Aimee K', 'Initials': 'AK', 'LastName': 'LaRiccia', 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Wolff', 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Magee', 'Affiliation': 'Columbus Radiology, Columbus, OH, USA.'}, {'ForeName': 'Roocha', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Columbus Radiology, Columbus, OH, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hoenninger', 'Affiliation': 'Columbus Radiology, Columbus, OH, USA.'}, {'ForeName': 'M Shay', 'Initials': 'MS', 'LastName': ""Oxs'Mara"", 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}, {'ForeName': 'Urmil B', 'Initials': 'UB', 'LastName': 'Pandya', 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}, {'ForeName': 'Joshua H', 'Initials': 'JH', 'LastName': 'Hill', 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}, {'ForeName': 'Thanh V', 'Initials': 'TV', 'LastName': 'Nguyen', 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}, {'ForeName': 'M Chance', 'Initials': 'MC', 'LastName': 'Spalding', 'Affiliation': 'Division of Trauma and Acute Care Surgery, Ohio Health Grant Medical Center, Athens, OH, USA.'}]",International journal of critical illness and injury science,['10.4103/IJCIIS.IJCIIS_103_19']
2816,32904579,Short-Term Effect of Self-Selected Training Intensity on Ambulatory Blood Pressure in Hypertensive Older Women: A Randomized Controlled Trial.,"Purpose


To investigate the short-term effect of self-selected training intensity (SSTI) on ambulatory blood pressure (BP) in hypertensive older women.
Participants and Methods


This is a randomized, single-blind, two-arm, parallel-group controlled trial that included 40 medicated hypertensive older women (64.4±3.6 years; resting systolic 118±19 and diastolic BP 68±9 mmHg). SSTI intervention was performed three times per week, 30-50 minutes per session (n=20). The control group participated in health education meetings once per week (n=20). Ambulatory BP (primary outcome) and six-minute walking test performance (secondary outcome) were assessed at baseline and following 8 weeks of intervention. Heart rate (HR), rating of perceived exertion (RPE, 6-20), and affective valence (ie, feeling scale, -5/+5) were recorded during all SSTI sessions. Intention-to-treat and per-protocol analyses were used for data analyses.
Results


Fifteen participants from the SSTI group and 17 from the control group completed the study. No differences in ambulatory BP (24-h, awake, and asleep) were observed between SSTI and control groups (intention-to-treat and per-protocol analyses; p>0.05). The SSTI group showed a greater six-minute walking test performance than the control group in the intention-to-treat and per-protocol analyses (p<0.05). The participants exercised at 52±10% of HR reserve reported an RPE of 11±1 and an affective valence of 3.4±1.1 over the 8-week period.
Conclusion


SSTI is a feasible approach to induce a more active lifestyle and increase health-related fitness in hypertensive older women, although it does not improve BP control over a short-term period.",2020,The SSTI group showed a greater six-minute walking test performance than the control group in the intention-to-treat and per-protocol analyses (p<0.05).,"['40 medicated hypertensive older women (64.4±3.6 years; resting systolic 118±19 and diastolic BP 68±9 mmHg', 'Fifteen participants from the SSTI group and 17 from the control group completed the study', 'Hypertensive Older Women', 'hypertensive older women']","['self-selected training intensity (SSTI', 'SSTI intervention', 'health education meetings', 'Self-Selected Training Intensity']","['ambulatory blood pressure (BP', 'Ambulatory Blood Pressure', 'BP control', 'Heart rate (HR), rating of perceived exertion (RPE, 6-20), and affective valence (ie, feeling scale, -5/+5', 'ambulatory BP (24-h, awake, and asleep', 'Ambulatory BP (primary outcome) and six-minute walking test performance', 'six-minute walking test performance']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",15.0,0.098489,The SSTI group showed a greater six-minute walking test performance than the control group in the intention-to-treat and per-protocol analyses (p<0.05).,"[{'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Sócrates', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Rodrigo Alberto Vieira', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Geovani Araújo Dantas', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Maria Beatriz Fonseca', 'Initials': 'MBF', 'LastName': 'Araújo', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ronildo', 'Initials': 'R', 'LastName': 'Paulo-Pereira', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Ludmila Lucena Pereira', 'Initials': 'LLP', 'LastName': 'Cabral', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Bruno Erick Barros', 'Initials': 'BEB', 'LastName': 'Lucena', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Luiz Fernando', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': 'Graduate Program in Psychobiology, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Eduardo Caldas', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Clinical interventions in aging,['10.2147/CIA.S260134']
2817,32904677,Performance bonuses in the public sector: Winner-take-all prizes versus proportional payments to reduce child malnutrition in India.,"We conduct a randomized trial to compare incentives for improved child outcomes among salaried caregivers in Chandigarh, India. A contest whose prize is divided among workers in proportion to measured gains yielded more improvement than a winner-take-all program. In our population of about 2000 children served by 85 workers, using proportional rewards led to weight-for-age malnutrition rates that were 4.3 percentage points lower at 3 months (when rewards were paid) and 5.9 points lower at 6 months (after the contest had ended), with mean weight-for-age z scores that were 0.071 higher at 3 months, and 0.095 higher at 6 months. Proportional bonuses led to larger and more sustained gains because of better performance by lower-ranked workers, whose efforts were not rewarded by a winner-take-all prize. Results are consistent with previous laboratory trials and athletic events, demonstrating the value of proportional rewards to improve development outcomes.",2020,"In our population of about 2000 children served by 85 workers, using proportional rewards led to weight-for-age malnutrition rates that were 4.3 percentage points lower at 3 months (when rewards were paid) and 5.9 points lower at 6 months (after the contest had ended), with mean weight-for-age z scores that were 0.071 higher at 3 months, and 0.095 higher at 6 months.","['salaried caregivers in Chandigarh, India', 'public sector']",[],"['weight-for-age malnutrition rates', 'mean weight-for-age z scores']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.0411582,"In our population of about 2000 children served by 85 workers, using proportional rewards led to weight-for-age malnutrition rates that were 4.3 percentage points lower at 3 months (when rewards were paid) and 5.9 points lower at 6 months (after the contest had ended), with mean weight-for-age z scores that were 0.071 higher at 3 months, and 0.095 higher at 6 months.","[{'ForeName': 'Prakarsh', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': 'Research Affiliate, Institute of Labor Economics (IZA), Germany.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Masters', 'Affiliation': 'Tufts University, Friedman School of Nutrition and Department of Economics, 150 Harrison Ave., Boston, MA 02111, USA.'}]",Journal of development economics,['10.1016/j.jdeveco.2018.10.003']
2818,32904678,Evaluating Rotational Stability of an Extended Depth of Focus Toric Intraocular Lens Using a Slit Lamp and Image-Based Analysis.,"Purpose


To evaluate the rotational stability of a toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software.
Setting


Three clinical practices in the USA.
Design


Prospective unmasked randomized clinical trial.
Methods


Subjects presenting for routine cataract surgery that were interested in improved near vision received toric EDOF lenses (TECNIS Symfony ®  Toric) in both eyes. The measures of interest in the current analysis were the change in orientation of the IOL between 1 day, 1 month and 3 months postoperative. Orientation was measured at the microscope on the day of surgery, and with the slit lamp at all other visits. Day 1, 1-month and 3-month images of the lens orientation were captured with a slit lamp camera. Differences in orientation were recorded and analyzed.
Results


A total of 150 eyes had IOL orientation data available. Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees. The percentage of lenses exhibiting rotation of ≤5 degrees between any measured time points was 97% or higher. Results were similar, but significantly more variable, when IOL orientation was measured at the slit lamp.
Conclusion


The toric EDOF lens evaluated here demonstrated rotational stability that exceeded the prior ANSI standard. The best method to determine IOL orientation changes was through image analysis.  .",2020,Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees.,['150 eyes had IOL orientation data available'],"['toric EDOF lenses (TECNIS Symfony ®  Toric', 'toric extended depth of focus (EDOF) intraocular lens (IOL), using either slit lamp evaluation or image-processing software']","['rotational stability', 'IOL orientation']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0183355', 'cui_str': 'Slit lamp biomicroscope'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]",150.0,0.0323327,Image analysis showed mean absolute lens orientation changes from 1 day to 1 month and 3 months of less than 2 degrees.,"[{'ForeName': 'Helga P', 'Initials': 'HP', 'LastName': 'Sandoval', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Associated Eye Care, Stillwater, MN, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Slade', 'Affiliation': 'Slade & Baker Vision, Houston, TX, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnenfeld', 'Affiliation': 'Ophthalmic Consultants of Long Island, Long Island, NY, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Potvin', 'Affiliation': 'Science in Vision, Bend, OR, USA.'}, {'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S272240']
2819,32904701,Allopurinol in Patients with Pulmonary Hypertension Associated with Chronic Lung Disease.,"Background


Oxidative stress (OS) has been implicated in the development of pulmonary hypertension (PH) and ventricular hypertrophy. Xanthine oxidase is a well-recognised source of reactive oxygen species, which lead to OS. The aim of this proof of concept study was to assess whether allopurinol (xanthine oxidase inhibitor) would reduce right ventricular mass (RVM) in patients with PH-associated chronic lung disease (PH-CLD).
Methods


We conducted a randomised, double-blind, parallel-group, placebo-controlled trial in patients with PH-CLD (93% COPD, 7% IPF) who were randomly assigned to receive allopurinol or placebo for 12 months. The primary outcome was the mean change in RVM, as assessed by cardiac magnetic resonance imaging (CMRI). Secondary outcomes included quality of life (QOL), spirometry and six-minute walk test (6MWT).
Results


Seventy-one patients were recruited: mean age 71 years, mean pulmonary arterial pressure 30 mm Hg, FEV 1  60% and resting SpO 2  96%. After 12 months, there was no significant difference in the change in RVM from baseline (allopurinol 1.85g vs placebo 0.97g with mean difference 0.88g, CI -4.77 to 3.01, p =0.7). There were also no significant changes in other cardiac parameters measured on MRI, in QOL, spirometry and 6MWT. Subgroup analysis showed that allopurinol significantly reduced RVM compared to placebo with -6.16g vs 0.75g and mean difference 6.92g (CI 1.14 to 12.69, p = 0.02) in COPD patients with more severe airflow limitation.
Conclusion


Allopurinol had no overall impact on patients with PH-CLD but had potential benefit in COPD patients with more severe airflow limitation.",2020,"There were also no significant changes in other cardiac parameters measured on MRI, in QOL, spirometry and 6MWT.","['patients with PH-CLD (93% COPD, 7% IPF', 'Seventy-one patients were recruited: mean age 71 years, mean pulmonary arterial\xa0pressure 30 mm Hg, FEV 1  60% and resting SpO 2  96', 'Patients with Pulmonary Hypertension Associated with Chronic Lung Disease', 'patients with PH-associated chronic lung disease (PH-CLD', 'COPD patients with more severe airflow limitation']","['allopurinol (xanthine oxidase inhibitor', 'placebo', 'Allopurinol', 'allopurinol or placebo', 'allopurinol', 'Xanthine oxidase']","['change in RVM', 'cardiac parameters measured on MRI, in QOL, spirometry and 6MWT', 'right ventricular mass (RVM', 'mean change in RVM, as assessed by cardiac magnetic resonance imaging (CMRI', 'quality of life (QOL), spirometry and six-minute walk test (6MWT', 'RVM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0055926', 'cui_str': 'clonidine-displacing substance'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0450396', 'cui_str': '30mm'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0302609', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043317', 'cui_str': 'Xanthine oxidase'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0455860', 'cui_str': 'Right ventricular mass'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",71.0,0.743189,"There were also no significant changes in other cardiac parameters measured on MRI, in QOL, spirometry and 6MWT.","[{'ForeName': 'Patrick S K', 'Initials': 'PSK', 'LastName': 'Liu-Shiu-Cheong', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Lipworth', 'Affiliation': 'Scottish Centre for Respiratory Research, Medical Research Institute, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Weir-McCall', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'J Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Imaging Science and Technology, University of Dundee, Dundee DD1 9SY, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Dundee DD1 9SY, UK.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S260917']
2820,32904711,Glucose-Dependent Insulinotropic Polypeptide (GIP) Reduces Bone Resorption in Patients With Type 2 Diabetes.,"Context


In healthy individuals, glucose-dependent insulinotropic polypeptide (GIP) enhances insulin secretion and reduces bone resorption by up to 25% estimated by absolute placebo-corrected changes in carboxy-terminal type 1 collagen crosslinks (CTX) during GIP and glucose administration. In patients with type 2 diabetes (T2D), GIP's insulinotropic effect is impaired and effects on bone may be reduced.
Objective


To investigate GIP's effect on bone biomarkers in patients with T2D.
Design


Randomized, double-blinded, crossover study investigating 6 interventions.
Patients


Twelve male patients with T2D.
Interventions


A primed continuous 90-minute GIP infusion (2 pmol/kg/min) or matching placebo (saline) administered at 3 plasma glucose (PG) levels (i.e., paired days with ""insulin-induced hypoglycemia"" (PG lowered to 3 mmol/L), ""fasting hyperglycemia"" (mean PG ~8 mmol/L), or ""aggravated hyperglycemia"" (mean PG ~12 mmol/L).
Main Outcome Measures


Bone biomarkers: CTX, procollagen type 1 N-terminal propeptide (P1NP) and PTH.
Results


On days with insulin-induced hypoglycemia, CTX was suppressed by up to 40 ± 15% during GIP administration compared with 12 ± 11% during placebo infusion ( P  < 0.0001). On days with fasting hyperglycemia, CTX was suppressed by up to 36 ± 15% during GIP administration, compared with 0 ± 9% during placebo infusion ( P  < 0.0001). On days with aggravated hyperglycemia, CTX was suppressed by up to 47 ± 23% during GIP administration compared with 10 ± 9% during placebo infusion ( P  = 0.0005). At all glycemic levels, P1NP and PTH concentrations were similar between paired days after 90 minutes.
Conclusions


Short-term GIP infusions reduce bone resorption by more than one-third (estimated by absolute placebo-corrected CTX reductions) in patients with T2DM, suggesting preserved bone effects of GIP in these patients.
Précis


Short-term GIP infusions reduce the bone resorption marker CTX by one-third in patients with type 2 diabetes independent of glycemic levels.",2020,"Bone biomarkers: CTX, procollagen type 1 N-terminal propeptide (P1NP) and PTH.
","['patients with T2D', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes (T2D', 'Patients\n\n\nTwelve male patients with T2D.\nInterventions\n\n\nA']","['primed continuous 90-minute GIP infusion (2 pmol/kg/min) or matching placebo (saline) administered at 3 plasma glucose (PG) levels (i.e., paired days with ""insulin-induced hypoglycemia"" (PG lowered to 3 mmol/L), ""fasting hyperglycemia"" (mean PG ~8 mmol/L), or ""aggravated hyperglycemia']","['bone biomarkers', 'Bone Resorption', 'bone resorption marker CTX', 'Glucose-Dependent Insulinotropic Polypeptide (GIP', 'hypoglycemia, CTX', 'bone resorption', 'glycemic levels, P1NP and PTH concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C2609269', 'cui_str': 'Fasting hyperglycaemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",12.0,0.365665,"Bone biomarkers: CTX, procollagen type 1 N-terminal propeptide (P1NP) and PTH.
","[{'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Asger B', 'Initials': 'AB', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa097']
2821,32917300,Fit to Study: Reflections on designing and implementing a large-scale randomized controlled trial in secondary schools.,"BACKGROUND


The randomised controlled trial (RCT) design is increasingly common among studies seeking good-quality evidence to advance educational neuroscience, but conducting RCTs in schools is challenging. Fit to Study, one of six such trials funded by the Education Endowment Foundation and Wellcome Trust, tested an intervention to increase vigorous physical activity during PE lessons on maths attainment among pupils aged 12-13. This review of designing and conducting an RCT in 104 schools is intended as a resource on which researchers might draw for future studies.
METHOD


We consider intervention design and delivery; recruitment, retention, trial management, data collection and analysis including ethical considerations and working with evaluators.
RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
CONCLUSION


Simple interventions, with few outcome measures and minimal missing data, are preferable to more complex designs.",2020,"RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
","['pupils aged 12-13', '104 schools']",[],[],"[{'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],[],,0.112651,"RESULTS


Teacher training, intervention delivery and data collection during large-scale RCTs require a flexible approach appropriate to educational settings, which in turn entails planning and resources.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wheatley', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU. Electronic address: catherine.wheatley@ndcn.ox.ac.uk.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Beale', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wassenaar', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Graham', 'Affiliation': 'Oxford Uehiro Centre for Practical Ethics, Wellcome Centre for Ethics and Humanities, University of Oxford, 6-17 St Ebbes St, Oxford OX1 1PT.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Eldridge', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Oxford Institute of Nursing, Midwifery & Allied Health Research, Department of Sport & Health Sciences, Oxford Brookes University, Headington Campus, Oxford OX3 0BP.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Johansen-Berg', 'Affiliation': 'Wellcome Centre for Integrative\xa0Neuroimaging, Nuffield Department of Clinical\xa0Neurosciences, University of Oxford, John Radcliffe Hospital, Oxford OX3 9DU.'}]",Trends in neuroscience and education,['10.1016/j.tine.2020.100134']
2822,32917317,"Effect of porcine placental extract on menopausal symptoms in postmenopausal women: A prospective, randomized, double-blind, placebo-controlled trial.","OBJECTIVES


To determine the effect of oral administration of porcine placental extract (PPE) on the menopausal symptoms of Korean women.
MATERIALS AND METHODS


This study was a multicenter, randomized double-blind placebo-controlled trial. A hundred menopausal Korean women were randomly allocated either to the PPE 400 mg per day or the control group during 12 weeks of the study period. Menopausal symptoms were evaluated using the Kupperman Index (KMI).
RESULTS


The KMI decreased after 12 weeks in both groups; however, the difference in the changes was not statistically significant. Among overweight or obese women whose body mass index (BMI) was 23 kg/m 2  or higher, the KMI decreased more significantly in the PPE group than placebo group after 12 weeks (-18.52 ± 9.09 vs -11.40 ± 10.68, P < 0.05). Among 49 early menopausal women whose duration of menopause was less than 3 years, the KMI decreased more significantly in the PPE group after 12 weeks (-17.29 ± 9.07 vs -11.29 ± 10.68, P < 0.05). The baseline estradiol level was not statistically different between the two groups before trial, but the estradiol level of the PPE group was significantly increased at 12 weeks (11.13 ± 35.13 pg/m, P < 0.05).
CONCLUSIONS


Oral administration of 400 mg PPE per day decreases menopausal symptoms in women with BMI 23 kg/m 2  or higher or in early menopausal women. PPE may be considered as a short-term complementary treatment to reduce menopausal symptoms, especially in overweight or early menopausal women.",2020,"The baseline estradiol level was not statistically different between the two groups before trial, but the estradiol level of the PPE group was significantly increased at 12 weeks (11.13 ± 35.13 pg/m, P ","['overweight or early menopausal women', 'A hundred menopausal Korean women', 'postmenopausal women', 'women with BMI 23\xa0kg/m 2  or higher or in early menopausal women', 'Korean women', '49 early menopausal women']","['porcine placental extract (PPE', 'placebo', 'PPE', 'porcine placental extract']","['body mass index (BMI', 'menopausal symptoms', 'baseline estradiol level', 'Menopausal symptoms', 'Kupperman Index (KMI', 'estradiol level', 'duration of menopause', 'KMI']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0032048', 'cui_str': 'Placental Extracts'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]",,0.493711,"The baseline estradiol level was not statistically different between the two groups before trial, but the estradiol level of the PPE group was significantly increased at 12 weeks (11.13 ± 35.13 pg/m, P ","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Konkuk University Hospital, Konkuk University School of Medicine, Seoul, Republic of Korea. Electronic address: jylee@kuh.ac.kr.'}, {'ForeName': 'Chulmin', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, CHA University Ilsan Medical Center, Goyang, Republic of Korea. Electronic address: morula3@gmail.com.'}, {'ForeName': 'Sang-Hee', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Department of Obstetrics and Gynecology, Sanggye Paik Hospital, Inje University School of Medicine, Seoul, Republic of Korea. Electronic address: psimy81@gmail.com.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Healthcare Review and Assessment Committee, Health Insurance Review and Assessment Service, Seoul, Republic of Korea. Electronic address: hoonchoi54@gmail.com.'}]",Taiwanese journal of obstetrics & gynecology,['10.1016/j.tjog.2020.07.009']
2823,32917318,Effectiveness and safety of atosiban versus conventional treatment in the management of preterm labor.,"OBJECTIVE


To compare the efficacy of atosiban with conventional treatment of the threatened preterm labor.
MATERIALS AND METHODS


All the data of pregnant women with threatened preterm labor from January 1 to December 31, 2017, who received atosiban were collected. Pregnant women with conventional treatment (including β-agonists, indomethacin, magnesium sulphate and calcium channel blockers, alone or in combination) were used as control.
RESULTS


The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33) (P < 0.0001). For therapy efficacy, there was also no significant difference between atosiban groups and conventional treatment groups in the low gestational ages. However, for the high gestational ages, atosiban treatment group showed higher efficacy (84%; n = 21/25 vs. 37.5%; n = 3/8) (P < 0.05). Moreover, a significantly higher proportion of women in the atosiban treated group (89.3%; n = 25/28) was observed compared with the conventional treatment groups (51.5%; n = 17/33) who did not receive an alternative tocolytic within 48 h (P < 0.01). Maternal and fetal safety was significantly superior with atosiban treatment.
CONCLUSIONS


Our results support that atosiban would represent an advance over current tocolytic therapy especially for the high gestational ages.",2020,The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33),"['pregnant women with threatened preterm labor from January 1 to December 31, 2017, who received atosiban were collected', 'Pregnant women with conventional treatment (including β-agonists', 'preterm labor', 'within 48']","['indomethacin, magnesium sulphate and calcium channel blockers, alone or in combination', 'alternative tocolytic', 'atosiban versus conventional treatment']","['efficacy', 'Maternal and fetal safety', 'proportion of women not requiring an alternative tocolytic treatment']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0022876', 'cui_str': 'Premature labor'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0040349', 'cui_str': 'Tocolytic agent'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}]",,0.0324973,The proportion of women not requiring an alternative tocolytic treatment within 48 h and remaining undelivered was significantly higher in atosiban treatment group (89.3%; n = 25/28) compared with conventional treatment (24.2%; n = 8/33),"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Joint Surgery, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; Clinic for Gynecology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China.'}, {'ForeName': 'Yuanfang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China. Electronic address: zhuyuanfang111@163.com.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics, Baoan Maternal and Child Health Hospital, Jinan University, Shenzhen, China. Electronic address: guofang2200@163.com.'}]",Taiwanese journal of obstetrics & gynecology,['10.1016/j.tjog.2020.07.010']
2824,32904162,"Efficacy and Tolerability of a Fixed-Dose Combination of Rosuvastatin and Ezetimibe Compared with a Fixed-Dose Combination of Simvastatin and Ezetimibe in Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized Trial.","BACKGROUND


The addition of ezetimibe to statin therapy has been reported to result in increased efficacy for reduction of LDL-C levels and achievement of lipid targets, compared with monotherapy.
OBJECTIVE


This study was designed to demonstrate the noninferiority of therapy with fixed-dose rosuvastatin plus ezetimibe formulations versus fixed dose simvastatin and ezetimibe formulations for reduction of LDL-C levels in Brazilian patients with hypercholesterolemia or mixed dyslipidemia.
METHODS


Phase III, multicenter, randomized, parallel, open-label, noninferiority study that included male and female participants (aged 21-80 years) with hypercholesterolemia or mixed dyslipidemia. After a 1-week screening period with washout of lipid-lowering medications when needed, patients were treated with simvastatin 20 mg/d for 5 weeks. Participants with LDL-C levels ≥100 mg/dL after the initial treatment were submitted to a 1-week washout period, and then randomized 1:1 to receive either combined rosuvastatin 10 mg + ezetimibe 10 mg (R/E) or simvastatin 20 mg + ezetimibe 10 mg (S/E) for 4 weeks and, if they still did not achieve the stipulated target, doses were readjusted to rosuvastatin 20 mg + ezetimibe 10 mg or simvastatin 40 mg + ezetimibe 10 mg, respectively, for 4 weeks.
RESULTS


One hundred twenty-nine participants were enrolled, including 66 in R/E and 63 in S/E. At the end of simvastatin 20 mg treatment period, mean LDL-C values were 124.79 mg/dL and 121.27 mg/dL for participants randomized to R/E and S/E arms, respectively. After 4 weeks of R/E 10 mg + 10 mg or S/E 20 mg + 10 mg combined treatments, adjusted mean LDL-C values were 74.21 mg/dL and 85.58 mg/dL, respectively ( P  = 0.0005), and after 9 weeks, with dose adjustment to R/E 20 mg + 10 mg in 6 patients and to S/E 40 mg +10 mg in 19 patients, LDL-C adjusted mean values were 75.29 mg/dL and 86.62 mg/dL, respectively ( P  = 0.0006). There was a statistically significant difference between the association R/E and S/E ( P  = 0.0013) in percentage change of LDL-C after 9 weeks of combined treatments. The adjusted mean difference was estimated at -10.32% (95% CI, -16.94% to -3.70%). The LDL-C <100 mg/dL target was achieved in a significantly greater proportion of participants at week 4 in the R/E compared with the S/E arm (84.8% vs 68.2%;  P  = .0257), and at week 9, the proportion was 81.2% versus 73.0%, respectively ( P  = 0.23). LDL-C <70 mg/dL was achieved at a significantly greater proportion in the R/E arm, both at week 4 (45.4% vs 15.9%;  P  = 0.003) and week 9 (40.9% vs 15.9%;  P  = 0.0017). A statistically significant difference at week 9 ( P  = 0.0106) was observed in fasting blood glucose in the R/E arm, but the overall incidence of adverse events was not significantly different between groups.
CONCLUSIONS


Rosuvastatin and ezetimibe fixed dose combination in both 10 mg/10 mg and 20 mg/10 mg doses, respectively, provided significantly lower levels of LDL-C compared with simvastatin and ezetimibe in doses of 20 mg/10 mg and 40 mg/10 mg, respectively. The fixed-dose combinations were both effective and well tolerated in this Brazilian study population. ClinicalTrials.gov identifier: NCT01420549. ( Curr Ther Res Clin Exp . 2020; 81:XXX-XXX).",2020,"<70 mg/dL was achieved at a significantly greater proportion in the R/E arm, both at week 4 (45.4% vs 15.9%;  P  = 0.003) and week 9 (40.9% vs 15.9%;  P  = 0.0017).","['Brazilian patients with hypercholesterolemia or mixed dyslipidemia', 'included male and female participants (aged 21-80\xa0years) with hypercholesterolemia or mixed dyslipidemia', 'One hundred twenty-nine participants were enrolled, including 66 in R/E and 63 in S/E', 'Participants with LDL-C levels ≥100 mg/dL after the initial treatment', 'Brazilian Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia']","['simvastatin and ezetimibe', 'ezetimibe', 'rosuvastatin 20 mg\u202f+\u202fezetimibe 10 mg or simvastatin 40\xa0mg\u202f+\u202fezetimibe', 'simvastatin 20 mg\u202f+\u202fezetimibe', 'Rosuvastatin and ezetimibe', 'combined rosuvastatin 10\xa0mg\u202f+\u202fezetimibe', 'LDL-C', 'simvastatin', 'Simvastatin and Ezetimibe', 'simvastatin and ezetimibe formulations', 'Rosuvastatin and Ezetimibe']","['mean LDL-C values', 'Efficacy and Tolerability', 'LDL-C levels', 'association R/E and S/E', 'fasting blood glucose', 'overall incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0560033', 'cui_str': 'in/s'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0342879', 'cui_str': 'Primary hypercholesterolemia'}]","[{'cui': 'C1532737', 'cui_str': 'simvastatin and ezetimibe'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C5136931', 'cui_str': 'rosuvastatin 20 MG [Ezallor]'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0989915', 'cui_str': 'Simvastatin 20 MG'}, {'cui': 'C3700394', 'cui_str': 'rosuvastatin and ezetimibe'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C5136932', 'cui_str': 'rosuvastatin 10 MG [Ezallor]'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",129.0,0.0478229,"<70 mg/dL was achieved at a significantly greater proportion in the R/E arm, both at week 4 (45.4% vs 15.9%;  P  = 0.003) and week 9 (40.9% vs 15.9%;  P  = 0.0017).","[{'ForeName': 'Antonio Carlos Amedeo', 'Initials': 'ACA', 'LastName': 'Vattimo', 'Affiliation': 'Departamento Médico Científico, Núcleo de Inovação, Aché Laboratórios Farmacêuticos SA, Guarulhos, São Paulo, Brasil.'}, {'ForeName': 'Francisco Antonio Helfestein', 'Initials': 'FAH', 'LastName': 'Fonseca', 'Affiliation': 'Departamento de Cardiologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Douglas Costa', 'Initials': 'DC', 'LastName': 'Morais', 'Affiliation': 'Departamento Médico Científico, Núcleo de Inovação, Aché Laboratórios Farmacêuticos SA, Guarulhos, São Paulo, Brasil.'}, {'ForeName': 'Larissa Fontes', 'Initials': 'LF', 'LastName': 'Generoso', 'Affiliation': 'Departamento Médico Científico, Núcleo de Inovação, Aché Laboratórios Farmacêuticos SA, Guarulhos, São Paulo, Brasil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Herrera', 'Affiliation': 'Departamento Médico Científico, Núcleo de Inovação, Aché Laboratórios Farmacêuticos SA, Guarulhos, São Paulo, Brasil.'}, {'ForeName': 'Cristiane Moraes', 'Initials': 'CM', 'LastName': 'Barbosa', 'Affiliation': 'Departamento Médico Científico, Núcleo de Inovação, Aché Laboratórios Farmacêuticos SA, Guarulhos, São Paulo, Brasil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'de Oliveira Izar', 'Affiliation': 'Departamento de Cardiologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brasil.'}, {'ForeName': 'Rita Antonelli', 'Initials': 'RA', 'LastName': 'Cardoso', 'Affiliation': 'Stats Estatística em Ciências e Negócios, São Paulo, SP, Brasil.'}, {'ForeName': 'Stevin', 'Initials': 'S', 'LastName': 'Zung', 'Affiliation': 'Departamento Médico Científico, Núcleo de Inovação, Aché Laboratórios Farmacêuticos SA, Guarulhos, São Paulo, Brasil.'}]","Current therapeutic research, clinical and experimental",['10.1016/j.curtheres.2020.100595']
2825,32904585,Low-pressure pulmonary recruitment maneuver: equal to or worse than moderate-pressure pulmonary recruitment maneuver in preventing postlaparoscopic shoulder pain? A randomized controlled trial of 72 patients.,"Introduction


The pulmonary recruitment maneuver (PRM) has emerged as an effective way of reducing post-laparoscopic shoulder pain (PLSP). However, the optimal lower pressure level for a PRM to reduce PLSP has not yet been investigated.
Aim


To compare the efficacy of the low-pressure PRM with moderate-pressure PRM in preventing PLSP.
Material and methods


Seventy-two ASA I-II patients who were scheduled for gynecologic LS for non-malignant conditions were enrolled in this study. Group 1 included patients who received the PRM at a maximum pressure of 30-40 cm H 2 O in a semi-Fowler position and group 2 included patients who received the PRM at a maximum pressure of 15 cm H 2 O in a semi-Fowler position. The primary outcome of the study was the difference in PLSP between the two groups.
Results


There were no significant differences in PLSP and wound pain VAS scores between patients receiving the PRM at 30 cm H 2 O and 15 cm H 2 O during postoperative pain monitoring (p < 0.05). The groups were also similar with respect to ambulation time (p = 0.215), length of hospital stay (p = 0.556) and the height of the pneumoperitoneum measured on chest X-ray (p = 0.151).
Conclusions


The low-pressure PRM (15 cm H 2 O pressure) provides similar efficacy as the moderate-pressure PRM (30-40 cm H 2 O) in terms of PLSP, wound pain, height of pneumoperitoneum, time of ambulation and length of hospital stay. We suggest that lower maximal inspiratory pressure of 15 cm H 2 O might be preferred to avoid the potential complications of the PRM with higher pressures.",2020,There were no significant differences in PLSP and wound pain VAS scores between patients receiving the PRM at 30 cm H 2 O and 15 cm H,"['Material and methods\n\n\nSeventy-two ASA I-II patients who were scheduled for gynecologic LS for non-malignant conditions', '72 patients']","['PRM', 'Low-pressure pulmonary recruitment maneuver: equal to or worse than moderate-pressure pulmonary recruitment maneuver', 'pulmonary recruitment maneuver (PRM']","['height of the pneumoperitoneum measured on chest X-ray', 'ambulation time', 'PLSP, wound pain, height of pneumoperitoneum, time of ambulation and length of hospital stay', 'PLSP and wound pain VAS scores', 'PLSP', 'length of hospital stay']","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0241745', 'cui_str': 'Wound pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",72.0,0.0473337,There were no significant differences in PLSP and wound pain VAS scores between patients receiving the PRM at 30 cm H 2 O and 15 cm H,"[{'ForeName': 'Gulseren', 'Initials': 'G', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Kiyak', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aysu', 'Initials': 'A', 'LastName': 'Akca', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Health Sciences, Faculty of Medicine, Kanuni Sultan Suleyman Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Salihoglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, Istanbul University, Cerrahpasa Medical School, Istanbul, Turkey.'}]",Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques,['10.5114/wiitm.2019.89831']
2826,32904603,Managing COPD with expiratory or inspiratory pressure load training based on a prolonged expiration pattern.,"Background


Exertional prolonged expiration should be identified as a therapeutic target in COPD. The efficacy of expiratory or inspiratory pressure load training (EPT/IPT) based on the degree of prolonged expiration was investigated.
Methods


A total of 21 patients with COPD were divided into two groups according to the exertional change in the inspiratory duty cycle ( T   I / T tot). For 12 weeks, patients whose exertional  T   I / T tot decreased received EPT (EPT group, n=11, mean percentage forced expiratory volume in 1 s (%FEV 1 ), 32.8%) and those whose exertional  T   I / T tot increased received IPT (IPT group, n=10, mean %FEV 1 , 45.1%).
Results


The therapeutic responses were as follows. In both groups, endurance time (EPT, +5.7 min, p<0.0001; IPT, +6.1 min, p=0.0004) on the constant work rate exercise test (WRET) and peak oxygen uptake increased (EPT, p=0.0028; IPT, p=0.0072). In the EPT group the following occurred: 1) soon after commencement of exercise with the constant WRET, the expiratory tidal volume ( V   T ex) increased, reducing dyspnoea; 2)  V   T ex and mean expiratory flow increased and then prolonged expiration (p=0.0001) improved at peak exercise with the incremental exercise test (ET); and 3) St. George's Respiratory Questionnaire total, activity and impact scores were improved. In the IPT group, on both the constant WRET and incremental ET, breathing frequency increased, which led to greater exercise performance with effort dyspnoea.
Conclusions


This study showed the benefits of EPT/IPT on exercise performance. If the choice of managing COPD with EPT/IPT is appropriate, inexpensive EPT/IPT may become widespread as home-based training.",2020,"In both groups, endurance time (EPT, +5.7 min, p<0.0001; IPT, +6.1 min, p=0.0004) on the constant work rate exercise test (WRET) and peak oxygen uptake increased (EPT, p=0.0028; IPT, p=0.0072).",['21 patients with COPD'],"['EPT/IPT', 'IPT (IPT', 'expiratory or inspiratory pressure load training (EPT/IPT', 'EPT (EPT']","[""peak exercise with the incremental exercise test (ET); and 3) St. George's Respiratory Questionnaire total, activity and impact scores"", 'endurance time', 'expiratory tidal volume ( V   T ex) increased, reducing dyspnoea; 2)  V   T ex and mean expiratory flow', 'constant work rate exercise test (WRET) and peak oxygen uptake', 'exercise performance', 'constant WRET and incremental ET, breathing frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",21.0,0.020975,"In both groups, endurance time (EPT, +5.7 min, p<0.0001; IPT, +6.1 min, p=0.0004) on the constant work rate exercise test (WRET) and peak oxygen uptake increased (EPT, p=0.0028; IPT, p=0.0072).","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Miki', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Tsujino', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Miki', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kagawa', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Oshitani', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Kiyoharu', 'Initials': 'K', 'LastName': 'Fukushima', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Matsuki', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kida', 'Affiliation': 'Dept of Respiratory Medicine, National Hospital Organization Osaka Toneyama Medical Center, Toyonaka, Japan.'}]",ERJ open research,['10.1183/23120541.00041-2020']
2827,32904611,Dexmedetomidine or midazolam in combination with propofol for sedation in endoscopic retrograde cholangiopancreatography: a randomized double blind prospective study.,"Introduction


Interventional endoscopic procedures, such as endoscopic retrograde cholangiopancreatography (ERCP), often require sedation during the procedure. The most commonly used drugs for this purpose are midazolam and propofol, which are used as sedative and hypnotic agents with minimal analgesic potential.
Aim


To compare the analgesic sedative effects of midazolam-propofol and dexmedetomidine-propofol combinations and their influence on hemodynamic and respiratory variables in patients undergoing ERCP.
Material and methods


Forty adult patients aged 20-78 and undergoing ERCP were randomized to two groups. Patients were premedicated with midazolam (0.05 mg/kg 10 min before the procedure) in group M and with dexmedetomidine (1 μg/kg for 10 min) in group D. Propofol was used for maintenance. The sedation level was monitored using the bispectral index (BIS) to maintain a score between 70 and 80. Hemodynamic and respiratory variables, recovery time and adverse events were recorded.
Results


The hemodynamic and respiratory variables were similar in both groups. Total propofol consumption was significantly lower in the dexmedetomidine group (208.5 ±80.0 vs. 154.5 ±66.7 mg; p = 0.011). The recovery period was shorter in group D (time to achieve the Aldrete score 9 was 9.4 ±2.1 vs. 6.6 ±1.1 min; p < 0.001). Changes in hemodynamic and respiratory variables and adverse events were not different between the two groups.
Conclusions


We found a shorter recovery time and comparable sedative and adverse effects with the dexmedetomidine-propofol combination compared with the midazolam-propofol combination. Dexmedetomidine in combination with propofol may be a safe and useful alternative for sedation for ERCP patients.",2020,We found a shorter recovery time and comparable sedative and adverse effects with the dexmedetomidine-propofol combination compared with the midazolam-propofol combination.,"['Forty adult patients aged 20-78 and undergoing ERCP', 'patients undergoing ERCP', 'endoscopic retrograde cholangiopancreatography', 'ERCP patients']","['Propofol', 'Dexmedetomidine or midazolam', 'propofol', 'dexmedetomidine-propofol', 'midazolam-propofol', 'Dexmedetomidine', 'dexmedetomidine', 'midazolam-propofol and dexmedetomidine-propofol combinations', 'midazolam and propofol', 'midazolam', 'endoscopic retrograde cholangiopancreatography (ERCP']","['hemodynamic and respiratory variables and adverse events', 'sedation level', 'shorter recovery time and comparable sedative and adverse effects', 'Hemodynamic and respiratory variables, recovery time and adverse events', 'analgesic sedative effects', 'Total propofol consumption', 'hemodynamic and respiratory variables']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",40.0,0.0560189,We found a shorter recovery time and comparable sedative and adverse effects with the dexmedetomidine-propofol combination compared with the midazolam-propofol combination.,"[{'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Koruk', 'Affiliation': 'Department of Anesthesiology and Reanimation, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Koruk', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, Demiroglu Bilim University, Istanbul, Turkey.'}, {'ForeName': 'Ayse Mizrak', 'Initials': 'AM', 'LastName': 'Arslan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Gaziantep University Faculty of Medicine, Gaziantep, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bilgi', 'Affiliation': 'Department of Anesthesiology and Reanimation, Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Rauf', 'Initials': 'R', 'LastName': 'Gul', 'Affiliation': 'Department of Anesthesiology and Reanimation, NCR International Hospital, Gaziantep, Turkey.'}, {'ForeName': 'Semsettin', 'Initials': 'S', 'LastName': 'Bozgeyik', 'Affiliation': 'Department of Anesthesiology and Reanimation, Defa Life Hospital, Gaziantep, Turkey.'}]",Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques,['10.5114/wiitm.2020.95066']
2828,32904645,Virtual Reality and Physical Models in Undergraduate Orthopaedic Education: A Modified Randomised Crossover Trial.,"Background


Orthopaedic surgery is underrepresented in the United Kingdom medical school curriculum, with an average of less than 3 weeks of exposure over the five-year degree. This study evaluates the effectiveness of high-fidelity virtual reality (VR) and physical model simulation in teaching undergraduate orthopaedic concepts.
Methods


A modified randomised crossover trial was used. Forty-nine students were randomly allocated to two groups, with thirty-three finishing the six-week follow-up assessment. All undergraduate medical students were eligible for inclusion. Both groups were given introductory lectures, before completing a pre-test with questions on the principles of fracture fixation and osteotomy. Each group then received a lecture on these topics with the same content, but one was delivered with VR and the other with physical models. Both groups completed the post-course assessments. Knowledge was assessed by way of questionnaire immediately before, immediately after, and six-weeks after.
Results


In the VR group, participants improved their post-training score by 192.1% (U=32;  p <0.00001). In the physical models group, participants improved their post-training scores by 163.1% (U=8.5;  p <0.00001). Overall, there was no statistically significant difference in the total means of post-training test scores between the VR and the physical models study groups (U=260.5;  p =0.4354).
Conclusion


Both VR and physical models represent valuable educational adjuncts for the undergraduate medical curriculum. Both have demonstrated improvements in immediate and long-term knowledge retention of key orthopaedic concepts.",2020,"In the VR group, participants improved their post-training score by 192.1% (U=32;  p <0.00001).","['Undergraduate Orthopaedic Education', 'All undergraduate medical students were eligible for inclusion', 'Forty-nine students']",['high-fidelity virtual reality (VR) and physical model simulation'],"['post-training scores', 'post-training score', 'total means of post-training test scores']","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",49.0,0.0208022,"In the VR group, participants improved their post-training score by 192.1% (U=32;  p <0.00001).","[{'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': ""Department of Medicine, St George's, University of London, London, UK.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zargaran', 'Affiliation': ""Department of Medicine, King's College London, London, UK.""}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Kokotkin', 'Affiliation': ""Department of Medicine, St George's, University of London, London, UK.""}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bhaskar', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zargaran', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Trompeter', 'Affiliation': ""Department of Trauma & Orthopaedic Surgery, St George's Hospital, London, UK.""}]",Orthopedic research and reviews,['10.2147/ORR.S252274']
2829,32905016,Effect of  in situ  aspartame mouthwash to prevent intrinsic and extrinsic erosive tooth wear.,"Background


The aim was to evaluate whether aspartame regular mouthwash prior to erosive challenges with citric or hydrochloric acids would be able to prevent erosive enamel wear.
Material and Methods


This randomized, single blind  in situ  study was conducted with 3 crossover phases of 5 days. Polished bovine enamel blocks (n=252) were randomly divided among 6 groups/ 3 phases/ 21 volunteers. The groups under study were: aspartame solution (0.024% of aspartame in deionized water - experimental group), deionized water (negative-control) and stannous-containing solution (Elmex® Erosion Protection Dental Rinse; positive-control); subjected to erosion on citric acid or hydrochloric acid. Four times per day the volunteers rinsed the intraoral appliance with the respective solutions ( in situ ) prior to immersion of half of the appliance in 0.05M citric acid and the other half in 0.01M hydrochloric acid for 120 seconds (extraoral). The response variable was enamel loss by profilometry. Data were analyzed by ANOVA and Tukey's test ( p <0.05).
Results


No difference on enamel loss was found between aspartame solution and deionized water. Stannous-solution resulted in less enamel loss compared to deionized water. Hydrochloric acid resulted in higher enamel loss than citric acid.
Conclusions


In this model, aspartame was not able to prevent erosive tooth wear against citric or hydrochloric acids.  Key words: Dental erosion, aspartame, stannous fluoride, citric acid, hydrochloric acid.",2020,No difference on enamel loss was found between aspartame solution and deionized water.,['n=252) were randomly divided among 6 groups/ 3 phases/ 21 volunteers'],"['Polished bovine enamel blocks', 'Stannous-solution', 'aspartame solution (0.024% of aspartame in deionized water - experimental group), deionized water (negative-control) and stannous-containing solution (Elmex® Erosion Protection Dental Rinse; positive-control); subjected to erosion on citric acid or hydrochloric acid', 'Hydrochloric acid', 'citric or hydrochloric acids', 'Dental erosion, aspartame, stannous fluoride, citric acid, hydrochloric acid']","['intrinsic and extrinsic erosive tooth wear', 'enamel loss']","[{'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0059034', 'cui_str': 'Elmex'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C0040436', 'cui_str': 'Erosion of teeth'}, {'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",252.0,0.0548318,No difference on enamel loss was found between aspartame solution and deionized water.,"[{'ForeName': 'Franciny-Querobim', 'Initials': 'FQ', 'LastName': 'Ionta', 'Affiliation': 'DDS, PhD; Assistant Professor, Department of Odontology. University of Marília.'}, {'ForeName': 'Marcela-de Azevedo-Garcia', 'Initials': 'MA', 'LastName': 'Bassoto', 'Affiliation': 'DDS, Graduate student, Department of Pediatric Dentistry, Orthodontics and Public Health Bauru. Bauru School of Dentistry, University of São Paulo. Brazil.'}, {'ForeName': 'Natália-Mello', 'Initials': 'NM', 'LastName': 'Dos Santos', 'Affiliation': 'DDS, PhD student, Department of Pediatric Dentistry, Orthodontics and Public Health Bauru. Bauru School of Dentistry, University of São Paulo. Brazil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Di Campli', 'Affiliation': 'DDS, MSc student, Department of Pediatric Dentistry, Orthodontics and Public Health. Bauru School of Dentistry, University of São Paulo. Brazil.'}, {'ForeName': 'Heitor-Marques', 'Initials': 'HM', 'LastName': 'Honório', 'Affiliation': 'DDS, PhD; Associate Professor, Department of Pediatric Dentistry, Orthodontics and Public Health. Bauru School of Dentistry, University of São Paulo. Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'DDS, PhD; Associate Professor, Department of Pediatric Dentistry, Orthodontics and Public Health. Bauru School of Dentistry, University of São Paulo. Brazil.'}, {'ForeName': 'Marilia-Afonso-Rabelo', 'Initials': 'MA', 'LastName': 'Buzalaf', 'Affiliation': 'DDS, PhD; Full Professor, Department of Biological Sciences. Bauru School of Dentistry, University of São Paulo. Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'DDS, PhD; Associate Professor, Department of Pediatric Dentistry, Orthodontics and Public Health. Bauru School of Dentistry, University of São Paulo. Brazil.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56857']
2830,32905021,The effect of composite resin preheating on marginal adaptation of class II restorations.,"Background


One of the problems with a high filler content composite resins is gap formation at restorative material-tooth interface. The present study investigated the effect of preheating composite resins on the formation of marginal gap in Cl II restorations.
Material and Methods


In this  in vitro  study Sixty Cl II cavities were prepared on the mesial and distal surfaces of 30 extracted premolar teeth. The gingival floor of cavities was placed 1 m below the CEJ. The samples were randomly allocated to 4 groups for restoration placement: group 1, Filtek P60 composite resin at room temperature; group 2, Filtek P60 composite resin at 68°C; group 3, X-tra fil composite resin at room temperature; and group 4, X-tra fil composite resin at 68°C. After a thermocycling procedure, the teeth were sectioned longitudinally in a buccolingual direction. Then the marginal gaps of the samples were measured at proximal and gingival margins under a scanning electron microscope at ×2000 magnification in µm. The data were analyzed with SPSS 21, using one-way ANOVA, post hoc Tukey tests and paired t-test (α=0.05).
Results


Groups 2 and 4 exhibited significantly lower marginal gaps, compared to groups 1 and 3, at both enamel ( P <0.0001 and  P =0.001, respectively) and dentinal walls ( P <0.0001). In all the groups, there was significantly less marginal gaps at composite-enamel wall compared to composite-dentin wall interfaces ( P <0.0001). There was no significant difference between groups 1 and 3 and groups 2 and 4 in enamel walls ( p = 0.96,  p = 0.99 respectively) and dentinal walls ( p = 0.85,  p =0.98 respectively).
Conclusions


Preheating resulted in a decrease in marginal gaps in both composite resins. The effect of composite resin type on marginal adaptation was the same.  Key words: Composite resin, dental marginal adaptation, preheating.",2020,"In all the groups, there was significantly less marginal gaps at composite-enamel wall compared to composite-dentin wall interfaces ( P <0.0001).",[],"['composite resin preheating', 'composite resin type', 'restoration placement: group 1, Filtek P60 composite resin at room temperature; group 2, Filtek P60 composite resin at 68°C; group 3, X-tra fil composite resin at room temperature; and group 4, X-tra fil composite resin']","['marginal adaptation of class II restorations', 'marginal gaps', 'gingival floor of cavities']",[],"[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1098777', 'cui_str': 'Filtek P60 Composite Resin'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C2354676', 'cui_str': 'X-tra fil composite resin'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",30.0,0.0455745,"In all the groups, there was significantly less marginal gaps at composite-enamel wall compared to composite-dentin wall interfaces ( P <0.0001).","[{'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Darabi', 'Affiliation': 'Associate professor, Department of Operative Dentistry, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Tayefeh-Davalloo', 'Affiliation': 'Associate professor, Department of Operative Dentistry, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Seyedeh-Maryam', 'Initials': 'SM', 'LastName': 'Tavangar', 'Affiliation': 'Associate professor, Department of Operative Dentistry, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Naser-Alavi', 'Affiliation': 'Assistant professor, Department of Operative Dentistry, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Mozhdeh', 'Initials': 'M', 'LastName': 'Boorboo-Shirazi', 'Affiliation': 'Dentist, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.56625']
2831,32905038,Effects of levetiracetam and lacosamide on therapeutic efficacy and neural function in patients with epilepsy.,"The present study aimed to investigate the effects of levetiracetam tablets and lacosamide (LCM) on therapeutic efficacy and neural function in patients with epilepsy. We assigned 252 patients with refractory partial seizures admitted to our hospital to receive either levetiracetam tablets [120 patients, the control group (CG)] or levetiracetam tablets combined with LCM [132 patients, the joint group (JG)]. The bone mineral density and neural function between the two groups at 6 months before and after treatment were compared. The total response rate was higher in the JG than in the CG (P<0.05). There was no significant difference in the comparison of the multiple indexes between the two groups before treatment (P>0.05). The frequency of seizures was reduced after treatment in the two groups, however, it was lower in the JG compared with the CG (P<0.05). The levels of neurological indicators were significantly reduced after treatment in the two groups (P<0.05), however, the reduction was more marked in the JG than in the CG. The bone mineral density (BMD) of the femoral neck decreased after treatment in the two groups (P<0.05), but there was no difference between the two groups after treatment (P>0.05). The calcium content decreased after treatment in the two groups (P<0.05), but there was no difference between the two groups after treatment (P>0.05). The comparison of other bone metabolism markers between the two groups exhibited no significant differences. The combination therapy greatly increased the quality of life score and the 1-year drug retention rate. To sum up, levetiracetam tablets combined with LCM significantly enhanced the therapeutic effect and improved the neural function in patients with refractory partial seizures, however this therapy may cause a slight adverse effect on BMD and bone metabolism in the short term.",2020,"The levels of neurological indicators were significantly reduced after treatment in the two groups (P<0.05), however, the reduction was more marked in the JG than in the CG.","['patients with epilepsy', 'patients with refractory partial seizures', '252 patients with refractory partial seizures admitted to our hospital to receive either']","['levetiracetam and lacosamide', 'levetiracetam tablets combined with LCM', 'levetiracetam tablets', 'levetiracetam tablets and lacosamide (LCM', 'control group (CG)] or levetiracetam tablets combined with LCM']","['therapeutic effect', 'calcium content', 'total response rate', 'bone mineral density and neural function', 'frequency of seizures', 'bone metabolism markers', 'BMD and bone metabolism', 'quality of life score and the 1-year drug retention rate', 'therapeutic efficacy and neural function', 'bone mineral density (BMD) of the femoral neck', 'neural function', 'levels of neurological indicators']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C1248704', 'cui_str': 'Levetiracetam Oral Tablet'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",252.0,0.0261416,"The levels of neurological indicators were significantly reduced after treatment in the two groups (P<0.05), however, the reduction was more marked in the JG than in the CG.","[{'ForeName': 'Airong', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': ""Hong Kong Middle Road Clinic, Integrated Chinese and Western Medicine Hospital of Qingdao (The 5th People's Hospital of Qingdao), Qingdao, Shandong 266073, P.R. China.""}, {'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'Gu', 'Affiliation': ""Hong Kong Middle Road Clinic, Integrated Chinese and Western Medicine Hospital of Qingdao (The 5th People's Hospital of Qingdao), Qingdao, Shandong 266073, P.R. China.""}, {'ForeName': 'Mingjing', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Hong Kong Middle Road Clinic, Integrated Chinese and Western Medicine Hospital of Qingdao (The 5th People's Hospital of Qingdao), Qingdao, Shandong 266073, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9126']
2832,32905041,Combination of cranberry extract and D-mannose - possible enhancer of uropathogen sensitivity to antibiotics in acute therapy of urinary tract infections: Results of a pilot study.,"Uncomplicated lower urinary tract infections are extremely common in women. Antibiotic treatment for acute episodes and for recurrence prophylaxis has its drawbacks and alternative therapies are sought in order to reduce the antimicrobial resistance phenomenon and the intestinal dismicrobism expansion. There are few studies on the effect of combination of cranberry extract with D-mannose in acute urinary tract infection management. In a pilot, randomized study 93 non-pregnant, otherwise healthy women, were enrolled with mean age of 39.77±10.36, diagnosed with uncomplicated lower urinary tract infection. Medical history, clinical examination, urine culture and a list of complaints were noted at the baseline visit. In a first phase of the study, treatment with either guideline recommended antibiotic alone or in association with the investigated product (cranberry extract plus D-mannose) was prescribed and all patients were clinically examined at day 7. All ameliorated and cured patients received in a second phase of the study, in a double-blind manner, prophylaxis with the investigated product or placebo for another 21 days, then a second clinical examination and a check of the list of complaints were performed. The cure rates were higher at day 7 when investigated product was added to antibiotic (91.6 vs. 84.4%). In resistant strains, a significantly higher cure rate was shown when the investigated product was added to antibiotic prescribed (88.8 vs. 37.5%, P<0.0001). The effect of cranberry extract plus D-mannose combination in acute urinary tract infection episodes seems to be promising. The significant cure rate registered in the patients with antibiotic-resistant urine cultures may be explained by a beneficial influence of the product on the antimicrobial sensitivity. Further studies are needed on this subject.",2020,The cure rates were higher at day 7 when investigated product was added to antibiotic (91.6 vs. 84.4%).,"['acute therapy of urinary tract infections', '93 non-pregnant, otherwise healthy women, were enrolled with mean age of 39.77±10.36, diagnosed with uncomplicated lower urinary tract infection']","['cranberry extract with D-mannose', 'Antibiotic treatment', 'placebo', 'cranberry extract and D-mannose - possible enhancer', 'cranberry extract plus D-mannose combination']","['urinary tract infections', 'cure rate', 'cure rates']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0268821', 'cui_str': 'Lower urinary tract infectious disease'}]","[{'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0024742', 'cui_str': 'Mannose'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]",93.0,0.0892484,The cure rates were higher at day 7 when investigated product was added to antibiotic (91.6 vs. 84.4%).,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rădulescu', 'Affiliation': ""Department of Nephrology and Dialysis, 'St. John' Emergency Clinical Hospital, 421422 Bucharest, Romania.""}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'David', 'Affiliation': ""Department of Nephrology and Dialysis, 'St. John' Emergency Clinical Hospital, 421422 Bucharest, Romania.""}, {'ForeName': 'Flavia Liliana', 'Initials': 'FL', 'LastName': 'Turcu', 'Affiliation': ""Department of Nephrology and Dialysis, 'St. John' Emergency Clinical Hospital, 421422 Bucharest, Romania.""}, {'ForeName': 'Daniela Margareta', 'Initials': 'DM', 'LastName': 'Spătaru', 'Affiliation': ""Department of Nephrology and Dialysis, 'St. John' Emergency Clinical Hospital, 421422 Bucharest, Romania.""}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Popescu', 'Affiliation': ""Department of Nephrology and Dialysis, 'St. John' Emergency Clinical Hospital, 421422 Bucharest, Romania.""}, {'ForeName': 'Ileana Adela', 'Initials': 'IA', 'LastName': 'Văcăroiu', 'Affiliation': ""Department of Nephrology and Dialysis, 'St. John' Emergency Clinical Hospital, 421422 Bucharest, Romania.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.8970']
2833,32905335,Fixation of distal radius fractures using wide-awake local anaesthesia with no tourniquet (WALANT) technique: A randomized control trial of a cost-effective and resource-friendly procedure.,"Aims


We hypothesized that the wide-awake local anaesthesia with no tourniquet (WALANT) technique is cost-effective, easy to use, safe, and reproducible, with a low learning curve towards mastery, having a high patient satisfaction rate. Furthermore, WALANT would be a suitable alternative for the austere and developing nation environments where lack of funds and resources are a common issue.
Methods


This was a randomized control trial of 169 patients who required surgery for closed isolated distal radius fractures. The study was performed between March 2016 and April 2019 at a public sector level 1 trauma centre. General anaesthesia was used in 56 patients, Bier's block in 58 patients, and WALANT in 55 patients. Data were collected on pre-, peri-, and postoperative parameters, clinical outcome, hospital costs, and patient satisfaction. One-way analysis of variance (ANOVA) was used with a p-value of 0.05 being significant.
Results


Operations with WALANT proceeded sooner, and patients recovered faster, resulting in mean fewer missed working days (7.8 (SD 1.67)) compared with general anaesthesia (20.1 (SD 7.37)) or Bier's block (14.1 (SD 7.65)) (p < 0.001). The WALANT patients did not develop complications, while the other patients did (p < 0.04). Clinical outcomes did not differ, nor did surgeon qualification affect clinical outcomes. Mean hospital costs were lower for WALANT ($428.50 (SD 77.71)) than for general anaesthesia ($630.63 (SD 114.77)) or Bier's block ($734.00 (SD 37.54)) (p < 0.001). Patient satisfaction was also higher (p < 0.001).
Conclusion


WALANT for distal radius fractures results in a faster recovery, is more cost-effective, has similar clinical outcomes, and has fewer complications than general anaesthesia or Bier's block. This makes WALANT an attractive technique in any setting, but especially in middle- and low-income countries.Cite this article:  Bone Joint Res  2020;9(7):429-439.",2020,"Conclusion


WALANT for distal radius fractures results in a faster recovery, is more cost-effective, has similar clinical outcomes, and has fewer complications than general anaesthesia or Bier's block.","['March 2016 and April 2019 at a public sector level 1 trauma centre', '169 patients who required surgery for closed isolated distal radius fractures', ""56 patients, Bier's block in 58 patients, and WALANT in 55 patients""]","['General anaesthesia', 'wide-awake local anaesthesia with no tourniquet (WALANT) technique']","['Patient satisfaction', 'Mean hospital costs', 'pre-, peri-, and postoperative parameters, clinical outcome, hospital costs, and patient satisfaction']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0034035', 'cui_str': 'Public Sector'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0580806', 'cui_str': 'Local anesthetic intravenous regional block'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",169.0,0.0949705,"Conclusion


WALANT for distal radius fractures results in a faster recovery, is more cost-effective, has similar clinical outcomes, and has fewer complications than general anaesthesia or Bier's block.","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Tahir', 'Affiliation': 'Department of Orthopaedics Surgery, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Ejaz Ali', 'Initials': 'EA', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Orthopaedics Surgery, Mohtarma Benazir Bhutto Shaheed Medical College, Mirpur Azad Kashmir, Pakistan.'}, {'ForeName': 'Zain', 'Initials': 'Z', 'LastName': 'Zaffar', 'Affiliation': 'Department of Orthopaedics Surgery, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Anwar', 'Affiliation': 'Department of Orthopaedics Surgery, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Ameer Hamza', 'Initials': 'MAH', 'LastName': 'Mamoon', 'Affiliation': 'Department of Orthopaedics Surgery, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Department of Orthopaedics Surgery, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Allah Rakhio', 'Initials': 'AR', 'LastName': 'Jamali', 'Affiliation': 'Department of Orthopaedics Surgery, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Mehboob', 'Affiliation': 'Department of Orthopaedics Surgery, Sirsyed Medical College for Girls, Karachi, Pakistan.'}]",Bone & joint research,['10.1302/2046-3758.97.BJR-2019-0315.R1']
2834,32905367,Azithromycin combined with doxycycline in non-gonococcal urethritis.,"Non-gonococcal urethritis (NGU) is one of the most common sexually transmitted diseases caused by chlamydia or  mycoplasma . The present study aimed to explore the clinical efficacy of azithromycin combined with doxycycline in patients with NGU and its effect on serum levels of inflammatory cytokine interleukin-6 (IL-6). A total of 98 patients with non-gonococcal urethritis were prospectively selected, of which 46 patients were assigned to an azithromycin group (treated with azithromycin alone), while the rest were assigned to a combination group (treated with azithromycin and doxycycline). The conditions of the patients were evaluated and compared between the two groups. The treatment efficacy in patients in the combination group was significantly better than that in the azithromycin group, and the time to symptom relief, period of medication, recurrence rate within 1 year of withdrawal and level of serum IL-6 in the combination group were significantly lower than those in the azithromycin group. The quality of life of patients in the combination group was significantly improved compared to those in the azithromycin group. However, there was no significant difference in the incidence of adverse reactions between the two groups. Azithromycin combined with doxycycline was revealed to be more effective than azithromycin monotherapy for NGU.",2020,Azithromycin combined with doxycycline was revealed to be more effective than azithromycin monotherapy for NGU.,"['non-gonococcal urethritis', '98 patients with non-gonococcal urethritis', 'patients with NGU']","['doxycycline', 'azithromycin alone', 'azithromycin', 'azithromycin monotherapy', 'azithromycin and doxycycline', 'Azithromycin']","['adverse reactions', 'quality of life', 'time to symptom relief, period of medication, recurrence rate within 1 year of withdrawal and level of serum IL-6', 'serum levels of inflammatory cytokine interleukin-6 (IL-6']","[{'cui': 'C1112709', 'cui_str': 'Nongonococcal urethritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",98.0,0.0264932,Azithromycin combined with doxycycline was revealed to be more effective than azithromycin monotherapy for NGU.,"[{'ForeName': 'Zhongming', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Dermatology, Shengzhou People's Hospital, Shengzhou Branch Hospital of The First Affiliated Hospital of Zhejiang University, Shaoxing, Zhejiang 312400, P.R. China.""}, {'ForeName': 'Manli', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Dermatology, Zaozhuang Hospital, Zaozhuang Mining Group, Zaozhuang, Shandong 277100, P.R. China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Gynecology, Shengzhou People's Hospital, Shengzhou Branch Hospital of The First Affiliated Hospital of Zhejiang University, Shaoxing, Zhejiang 312400, P.R. China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ""Department of Dermatology, Shaoxing Shangyu People's Hospital, Shaoxing, Zhejiang 312300, P.R. China.""}, {'ForeName': 'Huazhou', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': ""Department of Doctor-Patient Office, Shengzhou People's Hospital, Shengzhou Branch Hospital of The First Affiliated Hospital of Zhejiang University, Shaoxing, Zhejiang 312400, P.R. China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Department of Dermatology, Xinchang People's Hospital, Shaoxing, Zhejiang 312500, P.R. China.""}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9125']
2835,32905459,Who is most likely to benefit from a positive psychological intervention? Moderator analyses from a randomized trial in people newly diagnosed with HIV.,"The  Intervention for those Recently Informed of their Seropositive Status  (IRISS) and other positive psychological interventions (PPIs) have demonstrated psychological and physical health benefits. However, meta-analyses suggest that PPIs may have differential effects depending on participants' sociodemographic and psychological characteristics. We therefore examined potential moderators of effects of IRISS for adults newly diagnosed with HIV ( N =159). While IRISS had similar effects on positive emotion across most subgroups (age, race, education, stress), depression was a significant moderator for positive emotion. When examining effects of IRISS on antidepressant use, age, race, education, depression, and perceived stress emerged as significant moderators. Neither optimism nor life events significantly moderated effects of IRISS on any outcome. Results have clinical implications that practitioners can use to inform which patients are most likely to benefit from PPI.",2020,"While IRISS had similar effects on positive emotion across most subgroups (age, race, education, stress), depression was a significant moderator for positive emotion.","['people newly diagnosed with HIV', 'adults newly diagnosed with HIV ( N =159']","['positive psychological interventions (PPIs', 'IRISS']",['positive emotion'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",159.0,0.0703529,"While IRISS had similar effects on positive emotion across most subgroups (age, race, education, stress), depression was a significant moderator for positive emotion.","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Addington', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Elaine O', 'Initials': 'EO', 'LastName': 'Cheung', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL.'}]",The journal of positive psychology,['10.1080/17439760.2020.1789702']
2836,31674861,"Pharmacokinetics, Safety, and Intraocular Pressure-Lowering Profile of Omidenepag Isopropyl, a Selective, Nonprostaglandin, Prostanoid EP2 Receptor Agonist, in Healthy Japanese and Caucasian Volunteers (Phase I Study).","Purpose:  Omidenepag isopropyl (OMDI) is a prodrug of OMD, a selective, nonprostaglandin, prostanoid EP2 receptor agonist. This phase I study aimed to investigate the pharmacokinetic properties, safety, and intraocular pressure (IOP)-lowering efficacy of OMDI.  Methods:  Fourteen healthy male volunteers (7 Japanese and 7 Caucasian) 20-35 years of age received 1 drop of OMDI 0.0025% at 9:00 h in both eyes for 7 days. Blood samples were taken predose and up to 8 h postdose on days 1, 3, and 7. The plasma concentration of OMD was determined using high-performance liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters measured included the maximum plasma concentration ( C max ) and the half-life ( t ½ ) of OMD. IOP, adverse events (AEs), ophthalmic examinations, vital signs, and laboratory values were assessed.  Results:   C max  for all subjects was reached after 10-15 min and decreased with a  t ½  of ∼30 min.  Ad hoc  statistical analyses found significant differences in some pharmacokinetic parameters between Japanese and Caucasian subjects, likely due to differences in body weight. These differences reduced over 7 days of dosing and were not thought to be clinically meaningful. There was no OMD accumulation after 7 days of repeated dosing. Mean IOP was reduced by ∼4-5 mmHg between baseline and 2 h postdose, remaining stable from day 3 onward. All AEs were mild and considered treatment related.  Conclusions:  Pharmacokinetic parameters of OMD were similar between Japanese and Caucasian subjects. There was no accumulation of OMD after 7 days of dosing. OMDI was well tolerated and demonstrated clinically significant IOP reductions.",2019,Pharmacokinetic parameters measured included the maximum plasma concentration ( C max ) and the half-life ( t ½ ) of OMD.,"['Healthy Japanese and Caucasian Volunteers', 'Japanese and Caucasian subjects', 'Fourteen healthy male volunteers (7 Japanese and 7 Caucasian) 20-35 years of age received 1 drop of OMDI 0.0025% at 9:00\u2009h in both eyes for 7 days']","['Omidenepag isopropyl (OMDI', 'Omidenepag Isopropyl, a Selective, Nonprostaglandin, Prostanoid EP2 Receptor Agonist']","['pharmacokinetic parameters', 'Pharmacokinetics, Safety, and Intraocular Pressure', 'maximum plasma concentration ( C max ) and the half-life ( t ½ ) of OMD', 'IOP, adverse events (AEs), ophthalmic examinations, vital signs, and laboratory values', 'OMD accumulation', 'plasma concentration of OMD', 'accumulation of OMD', 'body weight', 'pharmacokinetic properties, safety, and intraocular pressure', 'Mean IOP']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C4517387', 'cui_str': '0.0025'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C5139819', 'cui_str': 'omidenepag isopropyl'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0755085', 'cui_str': 'osteoadherin'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",14.0,0.0623864,Pharmacokinetic parameters measured included the maximum plasma concentration ( C max ) and the half-life ( t ½ ) of OMD.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Aihara', 'Affiliation': 'Department of Ophthalmology, University of Tokyo, Bunkyo-ku, Japan.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Santen, Inc., Emeryville, California.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Yamamura', 'Affiliation': 'Santen Pharmaceutical Co., Ltd., Ikoma, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Odani-Kawabata', 'Affiliation': 'Santen, Inc., Emeryville, California.'}, {'ForeName': 'Naveed K', 'Initials': 'NK', 'LastName': 'Shams', 'Affiliation': 'Santen, Inc., Emeryville, California.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0044']
2837,32045942,1 Hz Repetitive Transcranial Magnetic Stimulation of the Primary Motor Cortex: Impact on Excitability and Task Performance in Healthy Subjects.,"OBJECTIVE


Neuronavigated repetitive transcranial stimulation (rTMS) at a frequency of 1 Hz was shown to reduce excitability in underlying brain areas while increasing excitability in the opposite hemisphere. In stroke patients, this principle is used to normalize activity between the lesioned and healthy hemispheres and to facilitate rehabilitation. However, standardization is lacking in applied protocols, and there is a poor understanding of the underlying physiologic mechanisms. Furthermore, the influence of hemispheric dominance on the intervention has not been studied before. A systematic evaluation of the effects in healthy subjects would deepen the understanding of these mechanisms and offer insights into ways to improve the intervention.
METHODS


Twenty healthy subjects underwent five 15-minute sessions of neuronavigated rTMS or sham stimulation over their dominant or nondominant motor cortex. Dominance was assessed with the Edinburgh Handedness Inventory. Changes in both hemispheres were measured using behavioral parameters (finger tapping, grip force, and finger dexterity) and TMS measures (resting motor threshold, recruitment curve, motor area, and cortical silent period).
RESULTS


All subjects tolerated the stimulation well. A pronounced improvement was noted in finger tapping scores over the nonstimulated hemisphere as well as a nonsignificant reduction of the cortical silent period in the stimulated hemisphere, indicating a differential effect of the rTMS on both hemispheres. Grip force remained at the baseline level in the rTMS group while decreasing in the sham group, suggesting the rTMS counterbalanced the effects of fatigue. Lastly, dominance did not influence any of the observed effects.
CONCLUSIONS


This study shows the capability of the applied low-frequency rTMS protocol to modify excitability of underlying brain areas as well as the contralateral hemisphere. It also highlights the need for a better understanding of underlying mechanisms and the identification of predictors for responsiveness to rTMS. However, results should be interpreted with caution because of the small sample size.",2020,"Changes in both hemispheres were measured using behavioral parameters (finger tapping, grip force, and finger dexterity) and TMS measures (resting motor threshold, recruitment curve, motor area, and cortical silent period).
","['healthy subjects', 'Twenty healthy subjects', 'Healthy Subjects']","['rTMS', 'Hz Repetitive Transcranial Magnetic Stimulation of the Primary Motor Cortex', 'neuronavigated rTMS or sham stimulation over their dominant or nondominant motor cortex', 'Neuronavigated repetitive transcranial stimulation (rTMS']","['behavioral parameters (finger tapping, grip force, and finger dexterity) and TMS measures (resting motor threshold, recruitment curve, motor area, and cortical silent period', 'Excitability and Task Performance', 'finger tapping scores', 'Grip force']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0257588,"Changes in both hemispheres were measured using behavioral parameters (finger tapping, grip force, and finger dexterity) and TMS measures (resting motor threshold, recruitment curve, motor area, and cortical silent period).
","[{'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Engelhardt', 'Affiliation': 'Department of Neurosurgery, Charité Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Picht', 'Affiliation': 'Department of Neurosurgery, Charité Universitatsmedizin Berlin, Berlin, Germany.'}]","Journal of neurological surgery. Part A, Central European neurosurgery",['10.1055/s-0040-1701624']
2838,32917784,A Randomized Trial on the Effect of Phosphate Reduction on Vascular End Points in CKD (IMPROVE-CKD).,"BACKGROUND


Hyperphosphatemia is associated with increased fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality. Effects of phosphate-lowering medication on vascular calcification and arterial stiffness in CKD remain uncertain.
METHODS


To assess the effects of non-calcium-based phosphate binders on intermediate cardiovascular markers, we conducted a multicenter, double-blind trial, randomizing 278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg lanthanum carbonate or matched placebo thrice daily for 96 weeks. We analyzed the primary outcome, carotid-femoral pulse wave velocity, using a linear mixed effects model for repeated measures. Secondary outcomes included abdominal aortic calcification and serum and urine markers of mineral metabolism.
RESULTS


A total of 138 participants received lanthanum and 140 received placebo (mean age 63.1 years; 69% male, 64% White). Mean eGFR was 26.6 ml/min per 1.73 m 2 ; 45% of participants had diabetes and 32% had cardiovascular disease. Mean serum phosphate was 1.25 mmol/L (3.87 mg/dl), mean pulse wave velocity was 10.8 m/s, and 81.3% had abdominal aortic calcification at baseline. At 96 weeks, pulse wave velocity did not differ significantly between groups, nor did abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate. Serious adverse events occurred in 63 (46%) participants prescribed lanthanum and 66 (47%) prescribed placebo. Although recruitment to target was not achieved, additional analysis suggested this was unlikely to have significantly affected the principle findings.
CONCLUSIONS


In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo. These findings do not support the role of intestinal phosphate binders to reduce cardiovascular risk in patients with CKD who have normophosphatemia.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Australian Clinical Trials Registry, ACTRN12610000650099.",2020,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","['278 participants with stage 3b or 4 CKD and serum phosphate >1.00 mmol/L (3.10 mg/dl) to 500 mg', '138 participants received', 'patients with CKD who have normophosphatemia', 'mean age 63.1 years; 69% male, 64% White']","['phosphate-lowering medication', 'lanthanum carbonate or matched placebo', 'non-calcium-based phosphate binders', 'lanthanum', 'Phosphate Reduction', 'placebo']","['mean pulse wave velocity', 'abdominal aortic calcification', 'vascular calcification and arterial stiffness', 'pulse wave velocity', 'fibroblast growth factor 23 (FGF23), arterial calcification, and cardiovascular mortality', 'abdominal aortic calcification, serum phosphate, parathyroid hormone, FGF23, and 24-hour urinary phosphate', 'Mean serum phosphate', 'Serious adverse events', 'cardiovascular disease', 'arterial stiffness or aortic calcification', 'cardiovascular risk', 'abdominal aortic calcification and serum and urine markers of mineral metabolism', 'Mean eGFR', 'carotid-femoral pulse wave velocity']","[{'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0768119', 'cui_str': 'lanthanum carbonate'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0179302', 'cui_str': 'Binder'}, {'cui': 'C0023031', 'cui_str': 'Lanthanum'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C1168153', 'cui_str': 'Arterial calcification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",278.0,0.574529,"In patients with stage 3b/4 CKD, treatment with lanthanum over 96 weeks did not affect arterial stiffness or aortic calcification compared with placebo.","[{'ForeName': 'Nigel D', 'Initials': 'ND', 'LastName': 'Toussaint', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia Nigel.Toussaint@mh.org.au.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Pedagogos', 'Affiliation': 'Department of Medicine, The Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Lioufas', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Grahame J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'School of Medicine, University of Notre Dame, Sydney, New South Wales, Australia.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Pascoe', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sunil V', 'Initials': 'SV', 'LastName': 'Badve', 'Affiliation': 'St. George Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Valks', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Reata Pharmaceuticals, Plano, Texas.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cameron', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Katrina L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sylvia S M', 'Initials': 'SSM', 'LastName': 'Chen', 'Affiliation': 'Epworth Healthcare, Melbourne, Victoria, Australia.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Faull', 'Affiliation': 'Department of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Holt', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Jackson', 'Affiliation': 'Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'Concord Repatriation and General Hospital, Concord, New South Wales, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Kerr', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lau', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lai-Seong', 'Initials': 'LS', 'LastName': 'Hooi', 'Affiliation': 'Sultanah Aminah Hospital, Johor Bahru, Malaysia.'}, {'ForeName': 'Om', 'Initials': 'O', 'LastName': 'Narayan', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash Heart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kevan R', 'Initials': 'KR', 'LastName': 'Polkinghorne', 'Affiliation': 'Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Pollock', 'Affiliation': 'Kolling Institute, Royal North Shore Hospital, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robison', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Nephrology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Angela Yee Moon', 'Initials': 'AYM', 'LastName': 'Wang', 'Affiliation': 'Queen Mary Hospital, University of Hong Kong, Hong Kong.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Australasian Kidney Trials Network, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020040411']
2839,32917847,Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial.,"BACKGROUND


International guidelines for resuscitation recommend using positive end-expiratory pressure (PEEP) during ventilation of preterm newborns. Reliable PEEP-valves for self-inflating bags have been lacking, and effects of PEEP during resuscitation of term newborns are insufficiently studied. The objective was to determine if adding a new PEEP valve to the bag-mask during resuscitation of term and near-term newborns could improve heart rate response.
METHODS


This randomized controlled trial was performed at Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018). Helping Babies Breathe-trained midwives performed newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve. All live-born newborns who received bag-mask ventilation at birth were eligible. Heart rate response measured by ECG was the primary outcome, and clinical outcome and ventilation data were recorded.
RESULTS


Among 417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP. We found no difference in heart rate response. Median (interquartile range) measured PEEP in the PEEP group was 4.7 (2.0-5.6) millibar. The PEEP group received lower tidal volumes (4.9 [1.9-8.2] vs 6.3 [3.9-10.5] mL/kg;  P  = .02) and had borderline lower expired CO 2  (2.9 [1.5-4.3] vs 3.3 [1.9-5.0] %;  P  = .05). Twenty four-hour mortality was 9% in both groups.
CONCLUSIONS


We found no evidence for improved heart rate response during bag-mask ventilation with PEEP compared with no PEEP. The PEEP valve delivered a median PEEP within the intended range. The findings do not support routine use of PEEP during resuscitation of newborns around term.",2020,"Twenty four-hour mortality was 9% in both groups.
","['Newborn Resuscitation', '417 included newborns (median birth weight 3200 g), 206 were ventilated without and 211 with PEEP', 'Haydom Lutheran Hospital in Tanzania (September 2016 to June 2018', 'preterm newborns']","['PEEP', 'bag-mask ventilation', 'newborn resuscitation using self-inflating bags with or without a new, integrated PEEP valve']","['clinical outcome and ventilation data', 'Heart rate response', 'heart rate response', 'lower tidal volumes']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0337738', 'cui_str': 'Lutheran Church'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}]",,0.307533,"Twenty four-hour mortality was 9% in both groups.
","[{'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Holte', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Østfold Hospital Trust, Grålum, Norway; kari.holte@so-hf.no.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ersdal', 'Affiliation': 'Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Eilevstjønn', 'Affiliation': 'Strategic Research Department, Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Øystein', 'Initials': 'Ø', 'LastName': 'Gomo', 'Affiliation': 'Strategic Research Department, Laerdal Medical, Stavanger, Norway.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Klingenberg', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Thallinger', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Vestre Viken Hospital Trust, Bærum, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Linde', 'Affiliation': 'Faculty of Health Sciences, University of Stavanger, Stavanger, Norway.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Stigum', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Yeconia', 'Affiliation': 'Haydom Lutheran Hospital, Mbulu, Manyara, Tanzania; and.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Kidanto', 'Affiliation': 'Research, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Størdal', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Østfold Hospital Trust, Grålum, Norway.'}]",Pediatrics,['10.1542/peds.2020-0494']
2840,32917948,A community-based intervention to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh (CIVIC): a randomised trial.,"STUDY DESIGN


Randomised controlled trial.
OBJECTIVES


To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh.
SETTING


Bangladesh.
METHODS


A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation.
RESULTS


Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications.
CONCLUSION


A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.",2020,"There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications.
","['People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh', 'Bangladesh', 'people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital', 'Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control', 'people with spinal cord injury in Bangladesh', 'people with spinal cord injury in Bangladesh (CIVIC']","['sustainable community-based intervention', 'usual post-discharge care', '36 phone calls and three home visits', 'Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia']","['incidence or severity of complications', 'Survival status and date of death']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C3874886', 'cui_str': 'Is about'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443189', 'cui_str': 'Concealed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1148348', 'cui_str': 'Date of death'}]",410.0,0.29545,"There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications.
","[{'ForeName': 'Mohammad Sohrab', 'Initials': 'MS', 'LastName': 'Hossain', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Chapain, Savar, Dhaka, 1343, Bangladesh.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, University of Sydney, Kolling Institute, Royal North Shore Hospital, St Leonards, 2065, NSW, Australia. l.harvey@usyd.edu.au.'}, {'ForeName': 'Md Shofiqul', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Chapain, Savar, Dhaka, 1343, Bangladesh.'}, {'ForeName': 'Md Akhlasur', 'Initials': 'MA', 'LastName': 'Rahman', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Chapain, Savar, Dhaka, 1343, Bangladesh.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Muldoon', 'Affiliation': 'Muldoon Rehabilitation, 72 Liscreevin Road, Lisnarick, Co Fermanagh, BT94 1PZ, Northern Ireland.'}, {'ForeName': 'Fin', 'Initials': 'F', 'LastName': 'Biering-Sorensen', 'Affiliation': 'Department for Spinal Cord Injuries, University of Copenhagen, Havnevej 25, DK-3100, Hornbæk, Denmark.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, PO Box M201, Missenden Road, Camperdown, 2050, NSW, Australia.'}, {'ForeName': 'Hueiming', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, PO Box M201, Missenden Road, Camperdown, 2050, NSW, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, PO Box M201, Missenden Road, Camperdown, 2050, NSW, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, University of Sydney, Kolling Institute, Royal North Shore Hospital, St Leonards, 2065, NSW, Australia.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Taylor', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Chapain, Savar, Dhaka, 1343, Bangladesh.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, PO Box M201, Missenden Road, Camperdown, 2050, NSW, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, PO Box M201, Missenden Road, Camperdown, 2050, NSW, Australia.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Herbert', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Barker Street, Randwick, 2031, NSW, Australia.'}]",Spinal cord,['10.1038/s41393-020-00546-9']
2841,32918078,"Group Lifestyle Phone Maintenance for Weight, Health and Physical Function in Adults Ages 65-80 Years: A Randomized Clinical Trial.","BACKGROUND


Group lifestyle sessions with phone maintenance could improve weight, health, and function in vulnerable older adults.
METHOD


Community-dwelling adults (n = 322) with BMI (kg/m 2) ≥ 27 and additional risk factors received 12 one-hour in-person behavioral weight management group sessions then were randomized to 8 half-hour telephone sessions (n = 162) or newsletter control (N = 160) from 4-12 months with no treatment contact thereafter. Primary outcome was 0-12-month weight change. Cardiometabolic, short physical performance battery (SPPB), and self-reported activity changes were assessed at 12 and 24 months.
RESULTS


At baseline, mean (SD) age was 71.2 (4.3) and BMI was 33.8 (5.1). Participants were 77% women, 13% Black, 85% retired, averaging 4 medical conditions and taking blood pressure (67.4%) and lipid-lowering (51.6%) medications. At 12 months, a greater proportion of the phone group (66.0 %) achieved ≥ 5% weight loss compared with newsletter control (53.2%; P = 0.02). Mean [95% CI] weight loss was greater for phone (- 6.6 kg [-7.5, -5.8] than newsletter (- 5.1 kg [-7.2, -3.0]); P = 0.01). Modest lipid, glucose, and blood pressure improvements were found, but did not differ significantly between groups. Small SPPB and activity improvements were maintained at 12 and 24 months in both groups.
CONCLUSIONS


Brief phone contacts compared to newsletters enhanced weight loss maintenance among older high-risk adults at one-year, but not cardiometabolic outcomes. Modest functional improvements were observed in both. Lower-intensity maintenance contacts (phone or newsletter) for weight, health, and physical function in older adults warrant further study.",2020,"At 12 months, a greater proportion of the phone group (66.0 %) achieved ≥ 5% weight loss compared with newsletter control (53.2%; P = 0.02).","['older adults', 'vulnerable older adults', 'Participants were 77% women, 13% Black, 85% retired, averaging 4 medical conditions and taking blood pressure (67.4%) and lipid-lowering (51.6%) medications', 'Adults Ages', 'older high-risk adults', 'Community-dwelling adults (n = 322) with BMI (kg/m 2', '65-80 Years']",['12 one-hour in-person behavioral weight management group sessions then were randomized to 8 half-hour telephone sessions'],"['0-12-month weight change', 'weight loss', 'Modest functional improvements', 'Mean [95% CI] weight loss', 'Small SPPB and activity improvements', 'weight, health, and function', 'Cardiometabolic, short physical performance battery (SPPB), and self-reported activity changes', 'Modest lipid, glucose, and blood pressure improvements', 'weight, health, and physical function', 'weight loss maintenance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",322.0,0.0253103,"At 12 months, a greater proportion of the phone group (66.0 %) achieved ≥ 5% weight loss compared with newsletter control (53.2%; P = 0.02).","[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Miller', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Arena', 'Affiliation': 'Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Departments of Endocrinology and Geriatrics, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Bonny', 'Initials': 'B', 'LastName': 'Rockette-Wagner', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa229']
2842,32917556,Efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler delivered using co-suspension delivery technology in Japanese patients with moderate-to-very severe chronic obstructive pulmonary disease.,"BACKGROUND


PINNACLE-4 evaluated the efficacy and safety of the long-acting muscarinic antagonist/long-acting β 2 -agonist fixed-dose combination glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in patients from Asia, Europe, and the USA with moderate-to-very severe chronic obstructive pulmonary disease (COPD). This pre-specified analysis included Japanese patients in PINNACLE-4.
METHODS


In this double-blind randomized study (NCT02343458), patients received GFF MDI (18/9.6 μg), glycopyrrolate (GP) MDI (18 μg), formoterol fumarate (FF) MDI (9.6 μg), or placebo MDI twice daily for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV 1 ) over Weeks 12-24. Secondary lung function endpoints, patient-reported outcomes, and safety were assessed. The Japanese subpopulation (n = 150) analyses were exploratory.
RESULTS


GFF MDI improved change from baseline in morning pre-dose trough FEV 1  over Weeks 12-24 versus GP MDI, FF MDI, and placebo MDI (least squares mean [LSM] differences [95% confidence interval]: 69 [8-131], 60 [-1 to 121], and 275 [180-370] mL, respectively). GFF MDI numerically improved Transition Dyspnea Index focal score and change from baseline in St George's Respiratory Questionnaire total score versus placebo MDI (LSM differences 0.19 and -3.78, respectively). Treatment-related adverse events occurred in ≤4.5% of patients in any treatment group.
CONCLUSIONS


GFF MDI improved lung function versus monocomponents and placebo MDI in the Japan subpopulation of PINNACLE-4. The efficacy and safety results were generally consistent with those of the global study population, supporting the use of GFF MDI in Japanese patients with moderate-to-very severe COPD.",2020,"GFF MDI numerically improved Transition Dyspnea Index focal score and change from baseline in St George's Respiratory Questionnaire total score versus placebo MDI (LSM differences 0.19 and -3.78, respectively).","['patients from Asia, Europe, and the USA with moderate-to-very severe chronic obstructive pulmonary disease (COPD', 'Japanese patients with moderate-to-very severe chronic obstructive pulmonary disease', 'Japanese patients in PINNACLE-4', 'Japanese patients with moderate-to-very severe COPD']","['glycopyrrolate/formoterol fumarate', 'glycopyrrolate (GP) MDI (18\xa0μg), formoterol fumarate (FF) MDI (9.6\xa0μg), or placebo MDI', 'glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI', 'placebo MDI', 'GFF MDI']","['Transition Dyspnea Index focal score', 'adverse events', 'lung function', 'change from baseline in morning pre-dose trough forced expiratory volume', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.417999,"GFF MDI numerically improved Transition Dyspnea Index focal score and change from baseline in St George's Respiratory Questionnaire total score versus placebo MDI (LSM differences 0.19 and -3.78, respectively).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Gon', 'Affiliation': 'Nihon University School of Medicine, Division of Respiratory Medicine, Itabashi, Tokyo, Japan. Electronic address: gon.yasuhiro@nihon-u.ac.jp.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nishi', 'Affiliation': 'Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Nagaoka Red Cross Hospital, Nagaoka, Niigata, Japan.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Maes', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Osaka, Osaka, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Hirata', 'Affiliation': 'AstraZeneca K.K., Osaka, Osaka, Japan.'}, {'ForeName': 'Ubaldo J', 'Initials': 'UJ', 'LastName': 'Martin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'AstraZeneca, Morristown, NJ, USA; AstraZeneca, Gaithersburg, MD, USA.'}]",Respiratory investigation,['10.1016/j.resinv.2020.06.007']
2843,32917571,Autologous fat grafting seems to alleviate postherpetic neuralgia - a feasibility study investigating patient-reported levels of pain.,"BACKGROUND


Postherpetic neuralgia (PHN) is a relatively common side effect after an outbreak of herpes zoster (HZ), characterized by chronic neuropathic dermal pain. No effective treatment exists today. Fat grafting has shown promise in alleviating neuropathic pain, yet the exact mechanism of action, at a biological level, is not yet known. We report on the first human study using autologous fat grafting for treating PHN. Our hypothesis was that fat grafting can alleviate pain and improve the quality of life (QoL) in patients suffering from PHN. If successful, this could be a safe, cost-effective alternative to analgesics. This safety and feasibility study aimed to investigate the possible pain-relieving effect of autologous fat grafting on PHN.
METHODS


Ten adult patients suffering from PHN underwent autologous fat grafting to a dermal area of neuralgia, with a 12-week follow up. The primary endpoint was patient-reported pain. Secondary endpoints were patient-reported changes in QoL, and the degree and quality of the neuropathic pain.
RESULTS


The pain was measured by using a visual analog scale (range: 0-10). We observed improvements in both the average and maximum level of pain with a reduction of (-4.0 ± 3.1) and (-5.1 ± 3.9), respectively, (Δ mean ± SD), P<0.05. All parameters investigating neuropathic pain were significantly reduced. No improvement was seen in the QoL. The average amount of fat grafted was 208 ml. We observed no serious adverse effects.
CONCLUSION


This study suggests that autologous fat grafting can relieve chronic pain resulting from HZ. The next step toward routine clinical translation is to perform a randomized, blinded, placebo-controlled trial with a more extended follow-up period.",2020,All parameters investigating neuropathic pain were significantly reduced.,"['Ten adult patients suffering from PHN underwent autologous fat grafting to a dermal area of neuralgia', 'patients suffering from PHN']","['placebo', 'Fat grafting', 'autologous fat grafting', 'Autologous fat grafting']","['patient-reported changes in QoL, and the degree and quality of the neuropathic pain', 'neuropathic pain', 'chronic pain', 'patient-reported pain', 'quality of life (QoL', 'pain']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",10.0,0.0576015,All parameters investigating neuropathic pain were significantly reduced.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sollie', 'Affiliation': 'Research Unit of Plastic Surgery, Odense University Hospital. J. B. Winsløvsvej 4, indgang 20, 1. sal. 5000 Odense C, Denmark. Electronic address: martin.sollie@rsyd.dk.'}, {'ForeName': 'Jørn Bo', 'Initials': 'JB', 'LastName': 'Thomsen', 'Affiliation': 'Research Unit of Plastic Surgery, Odense University Hospital. J. B. Winsløvsvej 4, indgang 20, 1. sal. 5000 Odense C, Denmark.'}, {'ForeName': 'Jens Ahm', 'Initials': 'JA', 'LastName': 'Sørensen', 'Affiliation': 'Research Unit of Plastic Surgery, Odense University Hospital. J. B. Winsløvsvej 4, indgang 20, 1. sal. 5000 Odense C, Denmark.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.08.038']
2844,32917627,Effects of the re-esterified triglyceride (rTG) form of omega-3 supplements on dry eye following cataract surgery.,"BACKGROUND/AIMS


To evaluate the clinical outcomes of the systemic re-esterified triglyceride (rTG) form of omega-3 fatty acids in patients with dry eye symptoms after cataract surgery.
METHODS


This prospective comparative cohort study comprised 66 patients complaining of new-onset non-specific typical dry eye 1 month after uncomplicated cataract surgery. Subjects were randomly allocated into control and omega-3 groups based on administration of the systemic rTG form of omega-3 fatty acids for 2 months, in addition to use of artificial teardrop. Ocular surface parameters (Schirmer's test, tear break-up time, corneal staining score and matrix metalloproteinase-9 (MMP-9)) and subjective questionnaire results (Ocular Surface Disease Index (OSDI)) and Dry Eye Questionnaire [DEQ]) for dry eye were evaluated before and after omega-3 supplementation.
RESULTS


Two months after omega-3 supplementation, the Oxford score was lower in the omega-3 group than in the control group. There was an improvement of subjective symptom scores of OSDI and DEQ in the omega-3 group (both p<0.05). The ratio of increasing MMP-9 level in the omega-3 group was lower than that in the control group (p=0.027).
CONCLUSION


The rTG form of omega-3 supplementation might be related to reduction of ocular surface inflammation rather than secretion of tears, and it might be effective for non-specific typical dry eye after uncomplicated cataract surgery.
TRIAL REGISTRATION NUMBER


NCT04411615.",2020,"Two months after omega-3 supplementation, the Oxford score was lower in the omega-3 group than in the control group.","['66 patients complaining of new-onset non-specific typical dry eye 1 month after uncomplicated cataract surgery', 'patients with dry eye symptoms after cataract surgery', 'dry eye following cataract surgery']","['systemic re-esterified triglyceride (rTG', 'omega-3 supplements', 'control and omega-3 groups based on administration of the systemic rTG form of omega-3 fatty acids', 'omega-3 fatty acids', 're-esterified triglyceride (rTG']","[""Ocular surface parameters (Schirmer's test, tear break-up time, corneal staining score and matrix metalloproteinase-9 (MMP-9)) and subjective questionnaire results (Ocular Surface Disease Index (OSDI)) and Dry Eye Questionnaire [DEQ"", 'subjective symptom scores of OSDI and DEQ', 'ratio of increasing MMP-9 level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test""}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.0130776,"Two months after omega-3 supplementation, the Oxford score was lower in the omega-3 group than in the control group.","[{'ForeName': 'Jongyeop', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Young-Sik', 'Initials': 'YS', 'LastName': 'Yoo', 'Affiliation': ""Ophthalmology, Uijeongbu St. Mary's Hospital, The Catholic University of Korea, Uijeongbu-si, Gyeonggi-do, Korea (the Republic of).""}, {'ForeName': 'Eunhae', 'Initials': 'E', 'LastName': 'Shin', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Gyule', 'Initials': 'G', 'LastName': 'Han', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}, {'ForeName': 'Kyungyoon', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': 'Ophthalmology, Seongnam citizens medical center, Seongnam-si, Gyeonggi-do, Korea (the Republic of).'}, {'ForeName': 'Dong Hui', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of) donghui.lim@samsung.com tychung@skku.edu.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea (the Republic of).'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-317164']
2845,32917645,Inflammation Modulation by Vitamin D and Calcium in the Morphologically Normal Colorectal Mucosa of Colorectal Adenoma Patients in a Clinical Trial.,"Increased cyclooxygenase-2 (COX-2) and decreased 15-hydroxyprostaglandin dehydrogenase (15-HPGD) expression promote prostaglandin-mediated inflammation and colorectal carcinogenesis. Experimental studies suggest that vitamin D and calcium may inhibit these pathways, but their effects on colorectal tissue COX-2 and 15-HPGD expression in humans are unknown. We tested the effects of supplemental vitamin D (1,000 I.U./day) and/or calcium (1,200 mg/day) on COX-2 and 15-HPGD expression in the morphologically-normal rectal mucosa from 62 colorectal adenoma patients in a placebo-controlled chemoprevention trial. We measured biomarker expression using automated immunohistochemistry and quantitative image analysis at baseline and 1-year follow-up, and assessed treatment effects using mixed linear models. The primary outcome was the COX-2/15-HPGD expression ratio, since these enzymes function as physiologic antagonists. After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group. Among individuals with the functional vitamin D-binding protein isoform DBP2 (GC rs4588*A), the COX-2/15-HPDG ratio decreased 70% (P = 0.0006), 75% (P = 0.0002), and 60% (P = 0.006) in the vitamin D, calcium, and combined supplementation groups, respectively, relative to placebo. These results show that vitamin D and calcium favorably modulate the balance of expression of COX-2 and 15-HPGD-biomarkers of inflammation that are strongly linked to colorectal carcinogenesis-in the normal-appearing colorectal mucosa of colorectal adenoma patients (perhaps especially those with the DBP2 isoform).",2020,"After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group.",['62 colorectal adenoma patients in a placebo-controlled chemoprevention trial'],"['vitamin D', 'Vitamin D and Calcium', 'calcium + vitamin D', 'vitamin D and calcium', 'supplemental vitamin D (1,000 I.U./day) and/or calcium']","['Increased cyclooxygenase-2 (COX-2) and decreased 15-hydroxyprostaglandin dehydrogenase (15-HPGD) expression promote prostaglandin-mediated inflammation and colorectal carcinogenesis', 'COX-2 and 15-HPGD expression', 'COX-2/15-HPGD expression ratio, since these enzymes function as physiologic antagonists', 'COX-2/15-HPDG ratio', 'balance of expression of COX-2 and 15-HPGD-biomarkers of inflammation', 'mean COX-2/15-HPGD expression ratio in full-length crypts']","[{'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0044894', 'cui_str': '15-hydroxyprostaglandin dehydrogenase (NAD^+^)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0596263', 'cui_str': 'Oncogenesis'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0020390', 'cui_str': 'Hydroxyprostaglandin Dehydrogenase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.138362,"After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group.","[{'ForeName': 'David Corley', 'Initials': 'DC', 'LastName': 'Gibbs', 'Affiliation': 'Department of Epidemiology, Emory University, Rollins School of Public Health.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Emory University, Rollins School of Public Health.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College.'}, {'ForeName': 'W Dana', 'Initials': 'WD', 'LastName': 'Flanders', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health.'}, {'ForeName': 'Marjorie L', 'Initials': 'ML', 'LastName': 'McCullough', 'Affiliation': 'Department of Population Sciences, American Cancer Society.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Yacoub', 'Affiliation': 'Epidemiology, Rollins School of Public Health, Emory University.'}, {'ForeName': 'Tapasya', 'Initials': 'T', 'LastName': 'Raavi', 'Affiliation': 'Department of Epidemiology, Emory University, Rollins School of Public Health.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Rutherford', 'Affiliation': 'Gastroenterology, Emory University School of Medicine.'}, {'ForeName': 'March E', 'Initials': 'ME', 'LastName': 'Seabrook', 'Affiliation': 'GI, Consultants in Gastroenterology.'}, {'ForeName': 'Roberd M', 'Initials': 'RM', 'LastName': 'Bostick', 'Affiliation': 'Department of Epidemiology, u Emory University Rollins School of Public Health rmbosti@emory.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0140']
2846,32918907,Forced and voluntary aerobic cycling interventions improve walking capacity in individuals with chronic stroke.,"OBJECTIVES


To determine the efficacy of high-intensity cycling to improve walking capacity in persons with chronic stroke, identify variables that predict improvement in walking capacity, and quantify the relationship between Six Minute Walk Test (6MWT) and Cardiopulmonary Exercise (CPX) Test variables.
DESIGN


Secondary analysis of data from 2 randomized clinical trials SETTING: Research laboratory PARTICIPANTS: Individuals with chronic stroke (N=43) INTERVENTIONS: Participants were randomized to one of the following time-matched interventions, occurring 3 times per week for 8 weeks: 1) forced aerobic exercise and upper extremity repetitive task practice (FE+RTP, N=16), 2) voluntary aerobic exercise and upper extremity repetitive task practice (VE+RTP, N=14), or 3) a non-aerobic control group (control, N=13).
MAIN OUTCOME MEASURE


Change in walking capacity as measured by the 6MWT from baseline to end of treatment (EOT).
RESULTS


Significant increases were observed in distance traveled during the 6MWT at EOT compared to baseline in the FE+RTP (p<0.001) and VE+RTP (p<0.001) groups, but not in the control group (p=0.21). Among aerobic exercise participants, a multivariate regression analysis revealed that cycling cadence, power output, and baseline 6MWT distance were significant predictors of change in walking capacity.
CONCLUSIONS


An 8-week aerobic cycling intervention prescribed at 60-80% of heart rate reserve and moderate to high cadence and resistance led to significant improvements in walking capacity in our cohort of persons with chronic stroke. Individuals with low baseline levels of walking capacity may benefit most from aerobic cycling to improve over ground locomotion. While the 6MWT did not elicit a comparable cardiorespiratory response as the maximal exertion CPX test, the 6MWT can be considered a valid and clinically relevant submaximal test of cardiorespiratory function in individuals with chronic stroke.",2020,"RESULTS


Significant increases were observed in distance traveled during the 6MWT at EOT compared to baseline in the FE+RTP (p<0.001) and VE+RTP (p<0.001) groups, but not in the control group (p=0.21).","[' Individuals with chronic stroke (N=43', 'persons with chronic stroke', 'individuals with chronic stroke']","['6MWT', 'FE+RTP', 'Forced and voluntary aerobic cycling interventions', 'forced aerobic exercise and upper extremity repetitive task practice (FE+RTP, N=16), 2) voluntary aerobic exercise and upper extremity repetitive task practice (VE+RTP, N=14), or 3) a non-aerobic control group (control, N=13', 'aerobic exercise', 'aerobic cycling intervention']","['Change in walking capacity as measured by the 6MWT from baseline to end of treatment (EOT', 'Six Minute Walk Test (6MWT) and Cardiopulmonary Exercise (CPX) Test variables', 'cycling cadence, power output, and baseline 6MWT distance', 'walking capacity', 'distance traveled']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040802', 'cui_str': 'Travel'}]",,0.0933234,"RESULTS


Significant increases were observed in distance traveled during the 6MWT at EOT compared to baseline in the FE+RTP (p<0.001) and VE+RTP (p<0.001) groups, but not in the control group (p=0.21).","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Linder', 'Affiliation': 'Cleveland Clinic, Department of Physical Medicine and Rehabilitation, Cleveland, OH, USA; Cleveland Clinic, Department of Biomedical Engineering, Cleveland, OH, USA; Cleveland Clinic, Concussion Center, Cleveland, OH, USA. Electronic address: linders@ccf.org.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'Cleveland Clinic, Concussion Center, Cleveland, OH, USA.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Rosenfeldt', 'Affiliation': 'Cleveland Clinic, Department of Biomedical Engineering, Cleveland, OH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Cleveland Clinic, Department of Physical Medicine and Rehabilitation, Cleveland, OH, USA.'}, {'ForeName': 'Mandy Miller', 'Initials': 'MM', 'LastName': 'Koop', 'Affiliation': 'Cleveland Clinic, Department of Biomedical Engineering, Cleveland, OH, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Cleveland Clinic, Department of Physical Medicine and Rehabilitation, Cleveland, OH, USA.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': 'Cleveland Clinic, Department of Biomedical Engineering, Cleveland, OH, USA; Cleveland Clinic, Concussion Center, Cleveland, OH, USA; Cleveland Clinic, Center for Neurologic Restoration, Cleveland, OH, USA.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.08.006']
2847,32918964,Seven-year outcomes of uveitic macular edema: the Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study results.,"PURPOSE


To evaluate the long-term outcomes of uveitic macular edema DESIGN: Longitudinal follow-up of a cohort of participants in a randomized clinical trial PARTICIPANTS: 248 eyes of 177 participants with uveitic macular edema enrolled in the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study METHODS: Optical coherence tomography (OCT) measurements, taken at baseline and annually, were graded by reading-center graders masked to clinical data. Macular edema was defined as a center point macular thickness (CMT) >240 μm on time-domain OCT or time-domain OCT equivalent. Resolution of macular edema was defined as normalization of macular thickness on OCT. Relapse of macular edema was defined as increase in macular thickness to ≥240 μm in an eye that previously had resolution. Visual acuity was measured at each visit with logarithmic visual acuity charts.
MAIN OUTCOME MEASURES


Resolution and relapse of macular edema. Visual acuity.
RESULTS


Among 227 eyes with macular edema followed >1 year, the cumulative percent of eyes with macular edema resolving at any point during 7 years was 94% (95% confidence interval [CI]: 89%, 97%). Epiretinal membranes on OCT were associated with a lower likelihood of macular edema resolution (hazard ratio [HR] 0.74; 95% CI 0.55, 1.01; P=0.05). Among 177 eyes with resolved macular edema, the cumulative percent with relapse within 7 years was 43% (95% CI: 32%, 51%). Eyes in which macular edema resolved gained a mean of 6.24 letters (95% CI: 4.40, 8.09, P< 0.001) compared to eyes that remained free from macular edema during the 1-year follow-up intervals, whereas eyes where macular edema did not resolve experienced no gain in vision (mean change -1.30 letters; 95% CI: -2.70, 0.09, P=0.065), and eyes that developed macular edema during the year (either incident or relapsed) experienced a mean loss of -8.65 letters (95% CI: -11.5, -5.84, P< 0.001).
CONCLUSIONS


Given sufficient time and treatment, nearly all uveitic macular edema resolves, but episodes of relapse were common. Visual acuity results were better among eyes with resolved macular edema, suggesting that control of inflammation and resolution of macular edema might be visually-relevant treatment targets.",2020,"Epiretinal membranes on OCT were associated with a lower likelihood of macular edema resolution (hazard ratio [HR] 0.74; 95% CI 0.55, 1.01; P=0.05).","[' 248 eyes of 177 participants with uveitic macular edema enrolled in the Multicenter Uveitis Steroid Treatment Trial and Follow-up Study', '177 eyes with', '227 eyes with macular edema']","['Uveitis Steroid Treatment (MUST', 'Optical coherence tomography (OCT) measurements']","['macular thickness', 'Relapse of macular edema', 'Visual acuity results', 'gain in vision', 'uveitic macular edema', 'Visual acuity', 'macular edema', 'time-domain OCT or time-domain OCT equivalent', 'Resolution and relapse of macular edema', 'Resolution of macular edema', 'resolved macular edema', 'Macular edema', 'macular edema resolution']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0042164', 'cui_str': 'Uveitis'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}]",177.0,0.0526427,"Epiretinal membranes on OCT were associated with a lower likelihood of macular edema resolution (hazard ratio [HR] 0.74; 95% CI 0.55, 1.01; P=0.05).","[{'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Tomkins-Netzer', 'Affiliation': 'Institute of Ophthalmology, University College London, and Moorfields Eye Hospital, London, UK; Department of Ophthalmology, Lady Davis Carmel Medical Center, Ruth and Bruch Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Lightman', 'Affiliation': 'Institute of Ophthalmology, University College London, and Moorfields Eye Hospital, London, UK.'}, {'ForeName': 'Alyce E', 'Initials': 'AE', 'LastName': 'Burke', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology; Department of Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lyndell L', 'Initials': 'LL', 'LastName': 'Lim', 'Affiliation': 'Department of Ophthalmology, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Department of Ophthalmology, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Altaweel', 'Affiliation': 'Department of Ophthalmology and Reading Center, University of Wisconsin, Madison, School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Kempen', 'Affiliation': 'Department of Ophthalmology Harvard Medical School and Massachusetts Eye and Ear Infirmary, Boston, MA, USA; MCM Eye Unit, Myung Sung Christian Medical Center General Hospital and Medical School, Addis Ababa, Ethiopia.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Jabs', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology; Department of Ophthalmology, the Wilmer Eye Institute, the Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: djabs@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Members of the MUST Trial and Follow-up Study Research Group are listed online at aaojournal.aao.org.'}]",Ophthalmology,['10.1016/j.ophtha.2020.08.035']
2848,32919015,The effect of 12-week resistance exercise training on serum levels of cellular aging process parameters in elderly men.,"BACKGROUND


Regular physical activity has a positive effect on the prevention of cellular aging. The present study investigated the effect of 12-week resistance training (RT) on serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme in elderly men.
METHODS


For this purpose, 30 elderly men (age 66.23 ± 0.57 years) were randomly divided into two groups: resistance training group (RET, n = 15) and control group (CTR, n = 15). Participants in RET performed RT protocols with intensity of 60% one-repetition maximum (3×/week, 4 sets of the six exercise circuits). Body composition, physical functioning and, blood samples were assessed before (pre-test) and after (post-test) a 12-week intervention.
RESULTS


The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET. Also, we found a significant difference between the RET and CTR in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.037), PGC1-α (P = 0.007), and telomerase enzyme (P = 0.001).
CONCLUSIONS


12-Week RT increased the levels of proteins associated with the biological aging process in elderly men. It seems that the RT may have beneficial effects on cellular senescence and also improved impaired mitochondrial protein and enzymatic functional induced aging.",2020,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","['elderly men', '30 elderly men (age 66.23\u202f±\u202f0.57\u202fyears']","['12-week resistance training (RT', 'resistance exercise training', 'resistance training group (RET, n\u202f=\u202f15) and control group (CTR']","['PGC1-α', 'RET and CTR in serum levels of SIRT1', 'SIRT6', 'telomerase enzyme', 'serum levels of Sirtuin-1 (SIRT1), Sirtuin-3 (SIRT3), Sirtuin-6 (SIRT6), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC1-α), and telomerase enzyme', 'SIRT3', 'serum levels of SIRT1', 'Body composition, physical functioning and, blood samples']","[{'cui': 'C0524337', 'cui_str': 'Elderly man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C1136177', 'cui_str': 'Silent Mating Type Information Regulator 2-like Proteins'}, {'cui': 'C0087071', 'cui_str': 'Telomerase Reverse Transcriptase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C2720169', 'cui_str': 'Sirt3'}, {'cui': 'C1452082', 'cui_str': 'PPARGC1A protein, human'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",30.0,0.0157346,"The results showed that there was a significant increase in serum levels of SIRT1 (P = 0.001), SIRT3 (P = 0.001), SIRT6 (P = 0.02), PGC1-α (P = 0.001), and telomerase enzyme (P = 0.001) in RET.","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Hooshmand-Moghadam', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran; Department of Exercise Physiology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Eskandari', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Golestani', 'Affiliation': 'Department of Exercise Physiology, University of Birjand, Birjand, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Rezae', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Mahmoudi', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Abbas Ali', 'Initials': 'AA', 'LastName': 'Gaeini', 'Affiliation': 'Department of Exercise Physiology, University of Tehran, Tehran, Iran. Electronic address: aagaeini@ut.ac.ir.'}]",Experimental gerontology,['10.1016/j.exger.2020.111090']
2849,32919045,Celecoxib Significantly Reduces Opioid Use After Shoulder Arthroplasty.,"BACKGROUND


The opioid crisis has illuminated the risks of opioid use for pain management, with renewed interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory medication is an important component of multimodal pain management for patients undergoing orthopedic surgery. The purpose of this study was to evaluate the effect of celecoxib on pain control and opioid use after shoulder surgery.
METHODS


Patients scheduled for either total shoulder replacement (group 1) or rotator cuff repair (RCR, group 2) were candidates for the study. Exclusion criteria included allergy to celecoxib, coagulopathy, use of anticoagulants, baseline use of long-acting opioids, and history of medical conditions such as heart attack or stroke. Consenting patients were randomized by type of procedure using block randomization to receive either placebo or celecoxib one hour prior to the procedure and for 3 weeks postoperatively. Primary outcome measure of opioid utilization as measured by morphine equivalent dose (MED) was assessed. Secondary outcome measures included pain scores at 3 and 6 weeks postoperatively. Data was analyzed using multiple linear regression.
RESULTS


Of 1081 patients scheduled for either total shoulder replacement or rotator cuff repair from February 2014 to February 2018, 78 were enrolled for arthroplasty (group 1: 39 celecoxib, 39 placebo) and 79 were enrolled for RCR (group 2: 40 celecoxib, 39 placebo). Compared to the placebo arm, patients prescribed celecoxib took less MED by -168 (95% CI, -272, -64, p<0.01) at 3 weeks in the total population and by -197.7 (95%CI, -358, -38 p=0.02) in the arthroplasty group. Similarly, at 6 weeks, total MED used was -199 (95%CI, -356, -42 p<0.01) units for the total population, and -270 (95% CI, -524, -16, p=0.04) in the arthroplasty group. No statistically significant differences in opioid consumption were found between study arms in the cuff repair group, either at 3 or 6 weeks. Of note, preoperative opioid use was statistically associated with higher levels of opioid use in the total population and group 1 at 3 and 6 weeks (p<0.01 for all), but not in group 2 (p>0.05 for both).
CONCLUSIONS


Use of morphine equivalents was statistically significantly less at 3 and 6 weeks in patients who took celecoxib in the total population and in the arthroplasty group. Patients prescribed celecoxib for 3 weeks after shoulder surgery took less opioid medication for pain at 3 and 6 weeks. Multimodal pain control using celecoxib is an effective way to reduce postoperative opioid use in shoulder arthroplasty patients. Preoperative opioid use is associated with higher levels of opioid use after shoulder arthroplasty.",2020,"No statistically significant differences in opioid consumption were found between study arms in the cuff repair group, either at 3 or 6 weeks.","['patients undergoing orthopedic surgery', 'shoulder arthroplasty patients', 'Consenting patients', '1081 patients scheduled for either total shoulder replacement or rotator cuff repair from February 2014 to February 2018, 78 were enrolled for arthroplasty (group 1: 39', 'Patients scheduled for either']","['celecoxib', 'Celecoxib', 'placebo or celecoxib', 'RCR', 'total shoulder replacement (group 1) or rotator cuff repair (RCR', 'celecoxib, 39 placebo', 'placebo']","['opioid utilization as measured by morphine equivalent dose (MED', 'pain control and opioid use', 'total MED', 'opioid consumption', 'Opioid Use', 'pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0186662', 'cui_str': 'Arthroplasty of shoulder'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0186657', 'cui_str': 'Total shoulder replacement'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",78.0,0.104903,"No statistically significant differences in opioid consumption were found between study arms in the cuff repair group, either at 3 or 6 weeks.","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Burns', 'Affiliation': ''}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'LeMarr', 'Affiliation': ''}, {'ForeName': 'Amber L', 'Initials': 'AL', 'LastName': 'Childress', 'Affiliation': ''}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Morton', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Schroer', 'Affiliation': ''}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Wilson', 'Affiliation': ''}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.08.025']
2850,32905158,Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial.,"Background


Patients, particularly older people, often experience safety issues when transitioning from hospital to home. Although the evidence is currently equivocal as to how we can improve this transition of care, interventions that support patient involvement may be more effective. The 'Your Care Needs You' (YCNY) intervention supports patients to 'know more' and 'do more' whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required. The intervention aims to reduce emergency hospital readmissions and improve safety and experience during the transition to home.
Methods


As part of the Partners At Care Transitions (PACT) programme of research, a multi-centred cluster randomised controlled trial (cRCT) will be conducted to explore the feasibility of the YCNY intervention and trial methodology. Data will be used to refine the intervention and develop a protocol for a definitive cRCT.Ten acute hospital wards (the clusters) from varying medical specialties including older peoples' medicine, trauma and orthopaedics, cardiology, intermediate care, and stroke will be randomised to deliver YCNY or usual care on a 3:2 basis. Up to 200 patients aged 75 years and over and discharged to their own homes will be recruited to the study. Patients will complete follow-up questionnaires at 5-, 30-, and 90-days post-discharge and readmission data up to 90-days post-discharge will be extracted from their medical records.Study outcomes will include measures of feasibility (e.g. screening, recruitment, and retention data) and processes required to collect routine data at a patient and ward level. In addition, interviews and observations involving up to 24 patients/carers and 28 staff will be conducted to qualitatively assess the acceptability, usefulness, and feasibility of the intervention and implementation package to patients and staff. A separate sub-study will be conducted to explore how accurately primary outcome data (30-day emergency hospital readmissions) can be gathered for the definitive cRCT.
Discussion


This study will establish the feasibility of the YCNY intervention which aims to improve safety and experience during transitions of care. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of the YCNY intervention in a definitive cluster randomised controlled trial.
Trial registration


UK Clinical Research Network Portfolio: 42191; ISTCRN: ISRCTN51154948. Registered 16/07/2019.",2020,"You' (YCNY) intervention supports patients to 'know more' and 'do more' whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required.","['\n\n\nPatients, particularly older people', '200 patients aged 75\u2009years and over and discharged to their own homes will be recruited to the study']","['YCNY intervention', ""You' (YCNY) intervention""]","['emergency hospital readmissions', 'measures of feasibility (e.g. screening, recruitment, and retention data) and processes required to collect routine data at a patient and ward level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",200.0,0.126973,"You' (YCNY) intervention supports patients to 'know more' and 'do more' whilst in hospital in order that they better understand their health condition and medications, maintain their daily activities, and can seek help at home if required.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Baxter', 'Affiliation': 'Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, UK.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, UK.'}, {'ForeName': 'Jane K', 'Initials': 'JK', 'LastName': ""O'Hara"", 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cockayne', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sheard', 'Affiliation': 'York Trials Unit, University of York, York, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mills', 'Affiliation': 'Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-020-00655-5']
2851,30325270,Effects of upper and lower body wearable resistance on spatio-temporal and kinetic parameters during running.,"Wearable resistance training involves added load attached directly to the body during sporting movements. The effects of load position during running are not yet fully established. Therefore, the purpose of this research was to determine spatio-temporal and kinetic characteristics during submaximal running using upper, lower and whole-body wearable resistance (1-10% body mass (BM)). Twelve trained male runners completed eight 2-min treadmill running bouts at 3.9 m/s with and without wearable resistance. The first and last bouts were unloaded, while the middle 6 were randomised wearable resistance conditions: upper body (UB) 5% BM, lower body (LB) 1%, 3%, 5% BM and whole body (WB) 5%, 10% BM. Wearable resistance of 1-10% BM resulted in a significant increase in heart rate (5.40-8.84%), but minimal impact on spatio-temporal variables. Loads of 5% BM and greater caused changes in vertical stiffness, vertical and horizontal force, and impulse. Functional and effective propulsive force (2.95%, 2.88%) and impulse (3.40%, 3.38%) were significantly  (p  < 0.05) greater with LB5% than UB5%. Wearable resistance may be used to increase muscular kinetics during running without negatively impacting spatio-temporal variables. The application of these findings will vary depending on athlete goals. Future longitudinal studies are required to validate training contentions.",2020,"Functional and effective propulsive force (2.95%, 2.88%) and impulse (3.40%, 3.38%) were significantly  (p  < 0.05) greater with LB5% than UB5%.",['Twelve trained male runners completed eight'],['2-min treadmill running bouts at 3.9\xa0m/s with and without wearable resistance'],"['Functional and effective propulsive force', 'vertical stiffness, vertical and horizontal force, and impulse', 'Wearable resistance', 'heart rate', 'muscular kinetics']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",12.0,0.0197937,"Functional and effective propulsive force (2.95%, 2.88%) and impulse (3.40%, 3.38%) were significantly  (p  < 0.05) greater with LB5% than UB5%.","[{'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Couture', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Simperingham', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Cronin', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Anna V', 'Initials': 'AV', 'LastName': 'Lorimer', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Kilding', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Macadam', 'Affiliation': 'Sports Performance Research Institute New Zealand, Auckland University of Technology , Auckland, New Zealand.'}]",Sports biomechanics,['10.1080/14763141.2018.1508490']
2852,30536479,Ototoxicity in locally advanced head and neck cancer patients treated with induction chemotherapy followed by intermediate or high-dose cisplatin-based chemoradiotherapy.,"BACKGROUND


This study evaluated ototoxicity in locally advanced head and neck cancer patients treated in the CONDOR study with docetaxel/cisplatin/5-fluorouracil (TPF) followed by conventional radiotherapy with concomitant cisplatin 100 mg/m 2  on days 1, 22, and 43 (cis100+RT) versus accelerated radiotherapy with concomitant cisplatin weekly 40 mg/m 2  (cis40+ART).
METHODS


Sixty-two patients were treated in this study. Audiometry was performed at baseline, during TPF, before start of chemoradiotherapy, and 1, 4, 8, and 12 months after treatment.
RESULTS


A complete dataset of audiometric data was available of 12 patients treated with high-dose cisplatin and of 11 patients treated with intermediate-dose cisplatin. Patients in the high-dose group showed significant more hearing loss than in the intermediate group at 4 kHz ([z = 1.98; P = .04] and 8 kHz [z = 2.07; P < .03]). Interindividual variation was high in both groups.
CONCLUSION


After induction TPF, more ototoxicity was observed in chemoradiotherapy with cis100+RT than after chemoradiotherapy with cis40+ART.",2019,Patients in the high-dose group showed significant more hearing loss than in the intermediate group at 4 kHz ([z = 1.98; P = .04] and 8 kHz [z = 2.07; P < .03]).,"['locally advanced head and neck cancer patients treated in the CONDOR study with', 'locally advanced head and neck cancer patients treated with', '12 patients treated with high-dose', 'Sixty-two patients were treated in this study']","['cisplatin', 'docetaxel/cisplatin/5-fluorouracil (TPF) followed by conventional radiotherapy with concomitant cisplatin 100\u2009mg/m 2  on days 1, 22, and 43 (cis100+RT) versus accelerated radiotherapy with concomitant cisplatin weekly 40\u2009mg/m 2  (cis40+ART', 'intermediate-dose cisplatin', 'chemoradiotherapy with cis40+ART', 'induction chemotherapy followed by intermediate or high-dose cisplatin-based chemoradiotherapy', 'chemoradiotherapy with cis100+RT']","['ototoxicity', 'hearing loss', 'Ototoxicity', 'Interindividual variation']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4517835', 'cui_str': '62'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0235280', 'cui_str': 'Ototoxicity'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",62.0,0.0426526,Patients in the high-dose group showed significant more hearing loss than in the intermediate group at 4 kHz ([z = 1.98; P = .04] and 8 kHz [z = 2.07; P < .03]).,"[{'ForeName': 'Chantal M L', 'Initials': 'CML', 'LastName': 'Driessen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Leijendeckers', 'Affiliation': 'Department of Ear Nose and Throat/Audiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Snik', 'Affiliation': 'Department of Ear Nose and Throat/Audiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Winette T A', 'Initials': 'WTA', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan Paiul', 'Initials': 'JP', 'LastName': 'de Boer', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Takes', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Carla M L', 'Initials': 'CML', 'LastName': 'van Herpen', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Head & neck,['10.1002/hed.25434']
2853,30677137,A Monte Carlo method for comparing generalized estimating equations to conventional statistical techniques for discounting data.,"Discounting is the process by which outcomes lose value. Much of discounting research has focused on differences in the degree of discounting across various groups. This research has relied heavily on conventional null hypothesis significance tests that are familiar to psychologists, such as t-tests and ANOVAs. As discounting research questions have become more complex by simultaneously focusing on within-subject and between-group differences, conventional statistical testing is often not appropriate for the obtained data. Generalized estimating equations (GEE) are one type of mixed-effects model that are designed to handle autocorrelated data, such as within-subject repeated-measures data, and are therefore more appropriate for discounting data. To determine if GEE provides similar results as conventional statistical tests, we compared the techniques across 2,000 simulated data sets. The data sets were created using a Monte Carlo method based on an existing data set. Across the simulated data sets, the GEE and the conventional statistical tests generally provided similar patterns of results. As the GEE and more conventional statistical tests provide the same pattern of result, we suggest researchers use the GEE because it was designed to handle data that has the structure that is typical of discounting data.",2019,"To determine if GEE provides similar results as conventional statistical tests, we compared the techniques across 2,000 simulated data sets.",[],[],[],[],[],[],,0.0152982,"To determine if GEE provides similar results as conventional statistical tests, we compared the techniques across 2,000 simulated data sets.","[{'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Friedel', 'Affiliation': 'National Institute for Occupational Safety and Health.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'DeHart', 'Affiliation': 'Virginia Tech Carillion Research Institute.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Foreman', 'Affiliation': 'National Institute for Occupational Safety and Health.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Andrew', 'Affiliation': 'National Institute for Occupational Safety and Health.'}]",Journal of the experimental analysis of behavior,['10.1002/jeab.497']
2854,30853317,Comparison of visual quality and subjective outcomes among 3 trifocal intraocular lenses and 1 bifocal intraocular lens.,"PURPOSE


To compare visual quality and subjective outcomes between 3 trifocal intraocular lenses (IOLs) and 1 bifocal IOL.
SETTING


Clínica Oftalmológica Martínez de Carneros, Madrid, Spain.
DESIGN


Prospective case series.
METHODS


This study comprised patients having bilateral phacoemulsification and implantation of an AcrySof IQ PanOptix, AT LISA tri 839MP, FineVision, or Tecnis ZLB00 IOL. Postoperative evaluation included logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and distance-corrected near visual acuity (DCNVA); reading speed; through-focus logMAR visual acuity at 100%, 50%, and 12% contrast; and contrast sensitivity function (CSF) under photopic and mesopic conditions. Subjective outcomes were assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25).
RESULTS


The study enrolled 160 patients, 40 in each group. Six months postoperatively, there were no statistically significant between-group differences in the spherical equivalent, UDVA, CDVA, DCNVA, reading performance, or CSF under photopic and mesopic conditions. The defocus curves at 100%, 50%, and 15% of contrast showed that trifocal IOLs, especially the AcrySof PanOptix, had better intermediate performance than the bifocal IOL and comparable outcomes at far and near distances. There were no statistically significant differences in the postoperative NEI VFQ-25 questionnaire scores between the 4 IOL groups.
CONCLUSION


The trifocal IOLs provided better intermediate distance vision than the bifocal IOL without compromising distance or near vision.",2019,"There were no statistically significant differences in the postoperative NEI VFQ-25 questionnaire scores between the 4 IOL groups.
","['3 trifocal intraocular lenses and 1 bifocal intraocular lens', 'patients having bilateral phacoemulsification and implantation of an AcrySof IQ PanOptix, AT LISA tri 839MP, FineVision, or Tecnis ZLB00 IOL', 'Clínica Oftalmológica Martínez de Carneros, Madrid, Spain', '160 patients, 40 in each group']",['3 trifocal intraocular lenses (IOLs) and 1 bifocal IOL'],"['spherical equivalent, UDVA, CDVA, DCNVA, reading performance, or CSF under photopic and mesopic conditions', 'logarithm of the minimum angle of resolution (logMAR) uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and distance-corrected near visual acuity (DCNVA); reading speed; through-focus logMAR visual acuity', 'contrast sensitivity function (CSF) under photopic and mesopic conditions', 'postoperative NEI VFQ-25 questionnaire scores', 'visual quality and subjective outcomes', 'National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25']","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1275646', 'cui_str': 'Trifocal glasses'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C1275647', 'cui_str': 'Bifocal glasses'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}]","[{'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1955969', 'cui_str': 'National Eye Institute'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",160.0,0.0649063,"There were no statistically significant differences in the postoperative NEI VFQ-25 questionnaire scores between the 4 IOL groups.
","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Martínez de Carneros-Llorente', 'Affiliation': 'Clínica Oftalmológica Martínez de Carneros, Madrid, Spain; Fundación Jiménez Díaz, Madrid, Spain. Electronic address: amartinezdecarneros@gmail.com.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Martínez de Carneros', 'Affiliation': 'Clínica Oftalmológica Martínez de Carneros, Madrid, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Martínez de Carneros-Llorente', 'Affiliation': 'Clínica Oftalmológica Martínez de Carneros, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Jiménez-Alfaro', 'Affiliation': 'Fundación Jiménez Díaz, Madrid, Spain.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.12.005']
2855,30853551,Challenges in Recruiting Patients to a Controlled Feasibility Study of a Drug for Opioid-Induced Constipation: Lessons From the Population With Advanced Cancer.,,2019,,['Population With Advanced Cancer'],[],[],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]",[],[],,0.0162058,,"[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bull', 'Affiliation': 'Four Seasons Compassion for Life, Flat Rock, North Carolina, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bonsignore', 'Affiliation': 'Four Seasons Compassion for Life, Flat Rock, North Carolina, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Massie', 'Affiliation': 'Four Seasons Compassion for Life, Flat Rock, North Carolina, USA.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Riggs', 'Affiliation': 'MJHS Institute for Innovation in Palliative Care, New York, New York, USA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Knotkova', 'Affiliation': 'MJHS Institute for Innovation in Palliative Care, New York, New York, USA; Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Wellman', 'Affiliation': 'Hospice of the Western Reserve, Cleveland, Ohio, USA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Portenoy', 'Affiliation': 'MJHS Institute for Innovation in Palliative Care, New York, New York, USA; Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York, USA; Department of Neurology, Albert Einstein College of Medicine, Bronx, New York, USA; MJHS Hospice and Palliative Care, New York, New York, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2018.09.024']
2856,32531432,Whole exome sequencing reveals the different responsiveness to Enterovirus 71 vaccination in Chinese children.,"PURPOSE


To explore the molecular genetic mechanisms underlying different responsiveness to Enterovirus 71 (EV71) vaccine.
METHODS


We recruited 10,245 healthy children into a phase 3 clinical trial to evaluate the efficacy of EV71 vaccine in 2012. Fifty subjects from the trial were divided into the potent immune response group (20 subjects) and the ineffective immune response group (30 subjects). Whole-exome sequencing was performed for these 50 samples and we conducted bioinformatics analyses based on online public database.
RESULTS


A total of 222,180 germline variants were detected across 50 subjects. Single nucleotide variant (SNV)-based screening of the subjects with potent or ineffective immune response allowed the identification of a potentially detrimental heterozygous missense variant (c.3784C>T) in EEA1. We also retained TRIM59 and ABCA7 genes that contain different loss of function (LoF) variants shared in two cases and involved in the immune response process. Then, we conducted high-resolution typing of 9 classical HLA genes, HLA-DRB1*03:01, HLA-DQA1*05:01 and HLA-DQB1*02:01 alleles were frequently (recurrence ≥5) observed only in ineffective immune responders.
CONCLUSIONS


Our study is a meaningful attempt on the comparison of genomic profiles between potent and ineffective immune responders induced by EV71 vaccine, and several candidate potentially detrimental genes were identified.",2020,"*02:01 alleles were frequently (recurrence ≥5) observed only in ineffective immune responders.
","['Chinese children', '10,245 healthy children', 'Fifty subjects from the trial were divided into the potent immune response group (20 subjects) and the ineffective immune response group (30 subjects', '222,180 germline variants were detected across 50 subjects']","['HLA-DQB1', 'EV71 vaccine', 'HLA-DQA1']",['HLA-DRB1'],"[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0442726', 'cui_str': 'Detected'}]","[{'cui': 'C0122020', 'cui_str': 'HLA-DQB1 antigen'}, {'cui': 'C3853962', 'cui_str': 'Enterovirus 71 infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0122013', 'cui_str': 'HLA-DQA1'}]","[{'cui': 'C0122040', 'cui_str': 'HLA-DRB1 Antigen'}]",10245.0,0.0360648,"*02:01 alleles were frequently (recurrence ≥5) observed only in ineffective immune responders.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'NHC Key laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing 210009, China.'}, {'ForeName': 'Chengxiao', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 210029, China; Jiangsu Key Lab of Cancer Biomarkers, Prevention and Treatment, Collaborative Innovation Center for Cancer Medicine, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Ge', 'Affiliation': 'Office of Infection Management, Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Jiangsu 210029, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'NHC Key laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing 210009, China.'}, {'ForeName': 'Fanyue', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'NHC Key laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing 210009, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 210029, China; Jiangsu Key Lab of Cancer Biomarkers, Prevention and Treatment, Collaborative Innovation Center for Cancer Medicine, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Tian', 'Affiliation': 'Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 210029, China; Jiangsu Key Lab of Cancer Biomarkers, Prevention and Treatment, Collaborative Innovation Center for Cancer Medicine, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Ci', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 210029, China; Jiangsu Key Lab of Cancer Biomarkers, Prevention and Treatment, Collaborative Innovation Center for Cancer Medicine, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 210029, China; Jiangsu Key Lab of Cancer Biomarkers, Prevention and Treatment, Collaborative Innovation Center for Cancer Medicine, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Jingxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'NHC Key laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing 210009, China. Electronic address: jingxin42102209@126.com.'}, {'ForeName': 'Fengcai', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'NHC Key laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing 210009, China; Department of Epidemiology, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing 210029, China. Electronic address: jszfc@vip.sina.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.008']
2857,32918079,Association Between Long-Term Aspirin Use and Frailty in Men: The Physicians' Health Study.,"BACKGROUND


Chronic inflammation may lead to frailty, however the potential for anti-inflammatory medications such as aspirin to prevent frailty is unknown. We sought to examine the association between long-term aspirin use and prevalent frailty.
METHODS


We included 12,101 men ≥60 years who participated in the Physicians' Health Study I, a completed aspirin randomized controlled trial (1982-1989). Annual questionnaires collected self-reported data on daily aspirin use, lifestyle and clinical variables. Average aspirin use was summed into 2 categories: ≤60 days/yr and>60 days/yr. Frailty was assessed using a 33-item index 11 years after trial completion. A score ≥0.21 was considered frail. Propensity score inverse probability of treatment weighting was used for statistical control of confounding. Logistic regression models estimated odds of frailty as a function of categories of average aspirin use.
RESULTS


Mean age was 70.5 years (range 60-101). Following an average of 11±0.6 years of follow-up, aspirin use was reported as ≤60 days/yr for 15%; 2413 participants (20%) were frail. Frequency of aspirin use was associated with smoking, alcohol consumption, hypertension, and CVD, but negatively associated with bleeding and coumadin use. The OR (95% CIs) for frailty was 0.85 (0.76-0.96) for average aspirin use >60 days/yr vs aspirin use ≤60 days/yr. Results were similar using an alternate definition of frailty.
CONCLUSIONS


Long-term regular aspirin use is inversely associated with frailty among older men, even after consideration of multimorbidity and health behaviors. Work is needed to understand the role of medications with anti-inflammatory properties on aging.",2020,The OR (95% CIs) for frailty was 0.85 (0.76-0.96) for average aspirin use,"[""12,101 men ≥60 years who participated in the Physicians' Health Study"", 'Men', 'Mean age was 70.5 years (range 60-101', 'older men']",['aspirin'],"['smoking, alcohol consumption, hypertension, and CVD']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",12101.0,0.0404069,The OR (95% CIs) for frailty was 0.85 (0.76-0.96) for average aspirin use,"[{'ForeName': 'Ariela R', 'Initials': 'AR', 'LastName': 'Orkaby', 'Affiliation': 'Geriatric Research, Education, and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA.'}, {'ForeName': 'Laiji', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Alyssa B', 'Initials': 'AB', 'LastName': 'Dufour', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Sesso', 'Affiliation': ""Division of Aging, Brigham & Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Driver', 'Affiliation': 'Geriatric Research, Education, and Clinical Center (GRECC), VA Boston Healthcare System, Boston, MA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Djousse', 'Affiliation': ""Division of Aging, Brigham & Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': ""Division of Aging, Brigham & Women's Hospital, Harvard Medical School, Boston, MA.""}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa233']
2858,32918100,Get secure soon: attachment in abused adolescents and young adults before and after trauma-focused cognitive processing therapy.,"Severe posttraumatic stress symptoms (PTSS) are connected to a variety of health-related and interpersonal problems, among them are the insecure attachment orientations. However, psychotherapy seems to improve not only PTSS but also attachment insecurities. In a large multicenter, randomized clinical trial, the attachment characteristics and PTSS of 85 adolescents and young adults (aged 14-21 years) with clinically relevant abuse-related PTSS were assessed at study entry, at the end of treatment, and 3 months after the end of treatment. Participants were randomized either to a developmentally adapted cognitive processing therapy (D-CPT) or to a wait-list with treatment advice (WL/TA). The purpose of the study was to analyze the association between PTSS and attachment at study entry as well as changes in attachment during the trial. We found that attachment-related avoidance (AR avoidance) was positively associated with PTSS from both self-reports and clinician ratings, whereas attachment-related anxiety (AR anxiety) was only related to self-reported PTSS (Pearson correlation coefficients between 0.37 and 0.46). Changes in AR anxiety occurred in both conditions at some point during the study (baseline to 3-month follow-up effect size was d = 0.60 for D-CPT and d = 0.44 for WL/TA) whereas for AR avoidance, only participants in D-CPT improved significantly (baseline to 3-month follow-up effect size was d = 0.75). The results indicate that PTSS and attachment are connected. Positive changes in attachment insecurities brought about by trauma-focused psychotherapy seem possible.Trial registration: German Clinical Trials Register (DRKS); Germanctr.de; identifier: DRKS00004787; date of registration: 18 March 2013.",2020,Participants were randomized either to a developmentally adapted cognitive processing therapy (D-CPT) or to a wait-list with treatment advice (WL/TA).,"['85 adolescents and young adults (aged 14-21\xa0years) with clinically relevant abuse-related PTSS', 'abused adolescents and young adults before and after trauma-focused cognitive processing therapy']",['adapted cognitive processing therapy (D-CPT) or to a wait-list with treatment advice (WL/TA'],"['AR anxiety', 'attachment-related avoidance (AR avoidance', 'Severe posttraumatic stress symptoms (PTSS', 'attachment-related anxiety (AR anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",,0.0730482,Participants were randomized either to a developmentally adapted cognitive processing therapy (D-CPT) or to a wait-list with treatment advice (WL/TA).,"[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Rimane', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Ostenstr. 25, 85072, Eichstätt, Germany. eline.rimane@ku.de.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Steil', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Varrentrappstr. 40-42, 60486, Frankfurt am Main, Germany.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Renneberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universitaet of Berlin, Habelschwerdter Allee 45, 14195, Berlin, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rosner', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Ostenstr. 25, 85072, Eichstätt, Germany.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01637-x']
2859,32918131,"Results of the non-small cell lung cancer part of a phase III, open-label, randomized trial evaluating topical corticosteroid therapy for facial acneiform dermatitis induced by EGFR inhibitors: stepwise rank down from potent corticosteroid (FAEISS study, NCCH-1512).","PURPOSE


This FAEISS study was designed to confirm the superior efficacy of reactive topical corticosteroid strategies employing serially ranking-DOWN from very strong steroid levels for the treatment of facial acneiform rash induced by epidermal growth factor receptor (EGFR) inhibitors (EGFRIs), in comparison with strategies employing serially ranking-UP from weak steroid levels. This article reports the primary results of the non-small cell lung cancer (NSCLC) part of the trial.
METHODS


Patients with EGFR-mutated advanced NSCLC treated with erlotinib or afatinib were enrolled in the first registration. All patients received preemptive therapy with oral minocycline and heparinoid moisturizer from the initiation of an EGFR inhibitor. Enrolled patients who developed facial acneiform rash within 2 weeks were randomized at second registration to either a ranking-UP (WEAK) group or a ranking-DOWN group. The primary endpoint was incidence of grade ≥ 2 facial acneiform rash over 8 weeks.
RESULTS


Fifty-one patients were enrolled at the first registration and received EGFRIs (n = 30 for afatinib, n = 21 for erlotinib). However, 35 patients did not develop facial acneiform rash within 2 weeks; one patient discontinued preemptive treatment. Fifteen patients (29.4%) were enrolled in the second registration; nine were assigned to the WEAK group and six to the DOWN group. There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417). No patients developed severe facial acneiform rash within 10 weeks.
CONCLUSION


In NSCLC patients who received EGFRIs, preemptive therapy of oral minocycline and heparinoid moisturizer reduced facial acneiform rash incidence.
TRIAL REGISTRATION


UMIN000024113.",2020,"There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417).","['Patients with EGFR-mutated advanced NSCLC treated with erlotinib or afatinib were enrolled in the first registration', 'Fifty-one patients were enrolled at the first registration and received', 'Enrolled patients who developed facial acneiform rash within 2 weeks', 'Fifteen patients (29.4%) were enrolled in the second registration; nine']","['EGFRIs', 'ranking-UP (WEAK) group or a ranking-DOWN group', 'preemptive therapy with oral minocycline and heparinoid moisturizer from the initiation of an EGFR inhibitor', 'minocycline', 'topical corticosteroid therapy']","['severe facial acneiform rash', 'incidence of grade ≥ 2 facial acneiform rash', 'facial acneiform rash incidence', 'facial acneiform rash', 'incidence of grade ≥', '2 facial acneiform rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0019142', 'cui_str': 'Heparinoids'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",51.0,0.0654059,"There was no significant difference in the incidence of grade ≥ 2 facial acneiform rash between the WEAK group (one patient, twice) and the DOWN group (one patient, twice; p = 0.8417).","[{'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Nishino', 'Affiliation': 'Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan. kazumi.nishino@oici.jp.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Eisaku', 'Initials': 'E', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Mie University Graduate School of Medicine, Mie, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Department of Dermatology, Mie University Graduate School of Medicine, Mie, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Kikuchi', 'Affiliation': 'Department of Dermatology, Tohoku University Graduate School of Medicine, Miyagi, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Dermatological Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'Data Management Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Nozawa', 'Affiliation': 'Appearance Support Center, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kiyohara', 'Affiliation': 'Department of Dermatology, Shizuoka Cancer Center, Shizuoka, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05765-7']
2860,32918135,Betaine and choline status modify the effects of folic acid and creatine supplementation on arsenic methylation in a randomized controlled trial of Bangladeshi adults.,"PURPOSE


Methylation of ingested inorganic arsenic (InAs) to monomethyl- (MMAs) and dimethyl-arsenical species (DMAs) facilitates urinary arsenic elimination. Folate and creatine supplementation influenced arsenic methylation in a randomized controlled trial. Here, we examine if baseline status of one-carbon metabolism nutrients (folate, choline, betaine, and vitamin B 12 ) modified the effects of FA and creatine supplementation on changes in homocysteine, guanidinoacetate (GAA), total blood arsenic, and urinary arsenic metabolite proportions and indices.
METHODS


Study participants (N = 622) received 400 or 800 μg FA, 3 g creatine, 400 μg FA + 3 g creatine, or placebo daily for 12 weeks.
RESULTS


Relative to placebo, FA supplementation was associated with greater mean increases in %DMAs among participants with betaine concentrations below the median than those with levels above the median (FDR < 0.05). 400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03). Creatine treatment was associated with a significant decrease in %MMAs among participants with choline concentrations below the median (P = 0.04), but not among participants above the median (P = 0.94); this effect did not significantly differ between strata (P = 0.10).
CONCLUSIONS


Effects of FA and creatine supplementation on arsenic methylation capacity were greater among individuals with low betaine and choline status, respectively. The efficacy of FA and creatine interventions to facilitate arsenic methylation may be modified by choline and betaine nutritional status.
CLINICAL TRIAL REGISTRATION


Clinical Trial Registry Identifier: NCT01050556, U.S. National Library of Medicine, https://clinicaltrials.gov ; registered January 15, 2010.",2020,"400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03).","['Study participants (N\u2009=\u2009622) received', 'Bangladeshi adults']","['folic acid and creatine supplementation', 'FA and creatine interventions', 'Folate and creatine supplementation', 'placebo, FA supplementation', 'FA and creatine supplementation', '400 or 800\xa0μg FA, 3\xa0g creatine, 400\xa0μg FA\u2009+\u20093\xa0g creatine, or placebo', 'ingested inorganic arsenic (InAs) to monomethyl- (MMAs) and dimethyl-arsenical species (DMAs']","['arsenic methylation', 'homocysteine, guanidinoacetate (GAA), total blood arsenic, and urinary arsenic metabolite proportions and indices', 'MMAs', 'homocysteine', 'arsenic methylation capacity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0936225', 'cui_str': 'Inorganic arsenic'}, {'cui': 'C0003819', 'cui_str': 'Arsenic compound'}, {'cui': 'C0013013', 'cui_str': 'Commonwealth of Dominica'}]","[{'cui': 'C0003818', 'cui_str': 'Arsenic'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0120451', 'cui_str': 'guanidinoacetate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}]",,0.476248,"400 μg FA/day was associated with a greater decrease in homocysteine among participants with plasma folate concentrations below, compared with those above, the median (FDR < 0.03).","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Bozack', 'Affiliation': 'Division of Pulmonary Medicine, Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Caitlin G', 'Initials': 'CG', 'LastName': 'Howe', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Hall', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Slavkovich', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Ilievski', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Lomax-Luu', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Faruque', 'Initials': 'F', 'LastName': 'Parvez', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Abu B', 'Initials': 'AB', 'LastName': 'Siddique', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Shahriar', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad N', 'Initials': 'MN', 'LastName': 'Uddin', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Tariqul', 'Initials': 'T', 'LastName': 'Islam', 'Affiliation': 'Columbia University Arsenic Project in Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Graziano', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA.'}, {'ForeName': 'Mary V', 'Initials': 'MV', 'LastName': 'Gamble', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 1107E, New York, NY, 10032, USA. mvg7@cumc.columbia.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02377-z']
2861,32918512,"Physicians' very brief (30-second) intervention for smoking cessation on 13,671 smokers in China: A pragmatic randomized controlled trial.","BACKGROUND AND AIMS


Three to ten minutes of smoking cessation advice by physicians is effective to increase quit rates but not routinely practised. We examined the effectiveness of physicians' very brief (about 30 seconds) smoking cessation intervention on quit rates among Chinese outpatient smokers.
DESIGN


A pragmatic, open-label, individually randomized controlled trial.
SETTING


Seventy-two medical outpatient departments of hospitals and/or community health centers in Guangdong, China.
PARTICIPANTS


Chinese adults who were daily cigarette smokers (N = 13,671, 99% males) were invited by their physician to participate during outpatient consultation. Smokers who were receiving smoking cessation treatment or were judged to needed specialist treatment for cessation were excluded.
INTERVENTIONS


The intervention group (n = 7,015) received a 30-second intervention including physician's very brief advice, a leaflet with graphic warnings, and a card with contact information of available cessation services. The control group (n = 6,656) received a very brief intervention on consuming vegetables and fruits. A total of 3,466 participants in the intervention group were further randomized to receive a brief booster advice from trained study personnel through telephone one month following their doctor visit.
MEASUREMENTS


The primary outcome was self-reported 7-day point prevalence abstinence in the intervention and control group at the 12-month follow-up. Secondary outcomes included self-reported 30-day abstinence and biochemically validated abstinence at 12-month follow-up.
FINDINGS


By intention-to-treat, the intervention (vs. control) group had greater self-reported 7-day abstinence (9.1% vs. 7.8%; odds ratio (OR) 1.14; 95% Confidence Interval (CI) 1.03-1.26; P = .008) and 30-day abstinence (8.0% vs. 6.9%; OR 1.14 95% CI 1.03-1.27; P=0.01) at 12-month follow-up. The effect size increased when only participants who received the intervention from compliant physicians were included (7-day PPA OR = 1.42; 1.11-1.74). The group difference in biochemically validated abstinence was small (0.8% vs. 0.8%; OR 1.00 95% CI 0.71-1.42; P=0.99).
CONCLUSION


A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.",2020,A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.,"['13,671 smokers in China', 'Chinese outpatient smokers', '3,466 participants in the intervention group', 'mainly male smokers', 'Smokers who were receiving smoking cessation treatment or were judged to needed specialist treatment for cessation were excluded', 'Seventy-two medical outpatient departments of hospitals', 'Chinese adults who were daily cigarette smokers (N = 13,671, 99% males) were invited by their physician to participate during outpatient consultation', 'and/or community health centers in Guangdong, China']","[""physicians' very brief (about 30 seconds) smoking cessation intervention"", '30-second smoking cessation intervention', 'very brief intervention on consuming vegetables and fruits', 'brief booster advice from trained study personnel through telephone one month following their doctor visit', ""30-second intervention including physician's very brief advice, a leaflet with graphic warnings, and a card with contact information of available cessation services""]","['quit rates', '30-day abstinence', 'self-reported abstinence', 'self-reported 7-day point prevalence abstinence', 'effect size', 'self-reported 30-day abstinence and biochemically validated abstinence at 12-month follow-up', 'greater self-reported 7-day abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0221191', 'cui_str': 'Judge'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",3466.0,0.0775531,A 30-second smoking cessation intervention increased self-reported abstinence among mainly male smokers in China at 12-month follow-up (risk difference = 1.3%) and should be feasible to provide in most settings and delivered by all healthcare professionals.,"[{'ForeName': 'Yee Tak Derek', 'Initials': 'YTD', 'LastName': 'Cheung', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Population Health, Grossman School of Medicine, New York University, USA.'}, {'ForeName': 'Chao Qiang', 'Initials': 'CQ', 'LastName': 'Jiang', 'Affiliation': 'Guangzhou No.12 Hospital, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Run Sen', 'Initials': 'RS', 'LastName': 'Zhuang', 'Affiliation': 'Shenzhen Health Education and Promotion and Promotion Centre, Shenzhen, China.'}, {'ForeName': 'Wen Hui', 'Initials': 'WH', 'LastName': 'Gao', 'Affiliation': 'Shenzhen Health Education and Promotion and Promotion Centre, Shenzhen, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jin Hong', 'Initials': 'JH', 'LastName': 'Lu', 'Affiliation': 'Traditional Chinese Medical Hospital of Huangpu, Guangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Shenzhen Bao'an District Songgang People's Hospital Hongqiaotou Community Health Service Center, Shenzhen, China.""}, {'ForeName': 'Jun Feng', 'Initials': 'JF', 'LastName': 'Wang', 'Affiliation': 'The Fifth Affiliated Hospital of Sun Yat-sen University, Zhongshang, China.'}, {'ForeName': 'Yi Sheng', 'Initials': 'YS', 'LastName': 'Lai', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Jun Sheng', 'Initials': 'JS', 'LastName': 'Sun', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Jiu Chang', 'Initials': 'JC', 'LastName': 'Wu', 'Affiliation': ""Shenzhen Bao'an District Fuyong Hospital, Shenzhen, China.""}, {'ForeName': 'Chiang', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ""Shenzhen Bao'an District Fuyong Hospital, Shenzhen, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Shenzhen Longgang District Central Hospital, Shenzhen, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'Guangzhou No.12 Hospital, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jing Ying', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': ""Shenzhen Longgang District Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiu Yan', 'Initials': 'XY', 'LastName': 'Ou', 'Affiliation': 'ZhongShan City People Hospital.'}, {'ForeName': 'Liu Qing', 'Initials': 'LQ', 'LastName': 'Liu', 'Affiliation': ""Longhua District People's Hospital Yansong Community Center, Shenzhen, China.""}, {'ForeName': 'Zhuang Hong', 'Initials': 'ZH', 'LastName': 'Huang', 'Affiliation': 'The First Affiliated Hospital of Shantou University Medical College Guan Bu Zhai Mei Healthcare Station, Shantou, China.'}, {'ForeName': 'Sai Yin', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'School of Public Health, Hong Kong, China.'}, {'ForeName': 'Ho Cheung William', 'Initials': 'HCW', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng Hua', 'Initials': 'SH', 'LastName': 'Su', 'Affiliation': 'Health Care Center for Cadre of Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Tobacco Control Office, Chinese Center for Disease Control and Prevention, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Tobacco Control Office, Chinese Center for Disease Control and Prevention, China.'}, {'ForeName': 'Wei Hua', 'Initials': 'WH', 'LastName': 'Zhu', 'Affiliation': 'Guangzhou No.12 Hospital, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Lie', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Guangzhou No.12 Hospital, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Peiru', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': ""Guangzhou First Municipal People's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Institute of Geriatrics, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Kar Keung', 'Initials': 'KK', 'LastName': 'Cheng', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, UK.'}, {'ForeName': 'Tai Hing', 'Initials': 'TH', 'LastName': 'Lam', 'Affiliation': 'School of Public Health, Hong Kong, China.'}]","Addiction (Abingdon, England)",['10.1111/add.15262']
2862,32918513,Assessment of transcultural psychotherapy to treat resistant major depressive disorder in children and adolescents from migrant families: Protocol for a randomized controlled trial using mixed method and Bayesian approaches.,"OBJECTIVES


Cultural variations complicate psychiatric care, especially for migrant children. Transcultural psychotherapy (TCP) is an original psychotherapeutic technique developed to address complex situations of resistant mental disorders in the context of migration. This research will aim to assess the efficacy, the acceptability, and describe the therapeutic processes of TCP for the treatment of depression in first or second generation of migration children and adolescents.
METHOD


Mixed method study using a multicenter, Bayesian randomized clinical trial with blinded evaluation of the primary outcome. Two parallel groups of 40 children or adolescents from 6 to 20 years old and their family will be included. In the experimental group, patients will attend six sessions of transcultural therapy in addition to usual care.
RESULTS


The improved Clinical Global Impression scale scores at 6 months will be compared across groups. Qualitative analysis of families and therapists' interviews will allow to specify the therapeutic processes and acceptability of the therapy.
CONCLUSION


The findings will encourage the development and routinization of TCP for second-line use and its adaption as a first-line technique in this population.",2020,Transcultural psychotherapy (TCP) is an original psychotherapeutic technique developed to address complex situations of resistant mental disorders in the context of migration.,"['40 children or adolescents from 6 to 20 years old and their family will be included', 'migrant children', 'children and adolescents from migrant families']","['transcultural psychotherapy', 'TCP', 'Transcultural psychotherapy (TCP']",['Clinical Global Impression scale scores'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.095903,Transcultural psychotherapy (TCP) is an original psychotherapeutic technique developed to address complex situations of resistant mental disorders in the context of migration.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Lachal', 'Affiliation': 'AP-HP, Maison de Solenn, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Marie Rose', 'Initials': 'MR', 'LastName': 'Moro', 'Affiliation': 'AP-HP, Maison de Solenn, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Carretier', 'Affiliation': 'AP-HP, Maison de Solenn, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Amalini', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'AP-HP, Maison de Solenn, Hôpital Cochin, Paris, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Barry', 'Affiliation': 'CESP, Fac. de Médecine - Université Paris-Sud, Fac. de Médecine - UVSQ, INSERM, DevPsy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Falissard', 'Affiliation': 'CESP, Fac. de Médecine - Université Paris-Sud, Fac. de Médecine - UVSQ, INSERM, DevPsy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rouquette', 'Affiliation': 'CESP, Fac. de Médecine - Université Paris-Sud, Fac. de Médecine - UVSQ, INSERM, DevPsy, Université Paris-Saclay, Villejuif, France.'}]",International journal of methods in psychiatric research,['10.1002/mpr.1847']
2863,32918519,Shared spiritual beliefs between adolescents with cancer and their families.,"BACKGROUND


FAmily CEntered (FACE) Advance Care Planning helps family decision makers to understand and honor patients' preferences for future health care, if patients cannot communicate. Spiritual well-being is a key domain of pediatric oncology care and an integral dimension of pediatric advance care planning.
PROCEDURE


As part of four-site randomized controlled trial of FACE for teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads. The prevalence-adjusted and bias-adjusted kappa (PABAK) measured congruence on FACIT-Sp-EX-4.
RESULTS


Adolescents (126) had mean age of 16.9 years, were 57% female and 79% White. Religious/spiritual classifications were: Catholic (n = 18), Protestant (n = 76), Mormon (n = 3), none/atheist (n = 22), other (n = 5), and unknown (n = 2). Agreement at item level between spiritual well-being of adolescents and families was assessed. Three items had ≥90% agreement and Excellent PABAK: ""I have a reason for living,"" ""I feel loved,"" ""I feel compassion for others in the difficulties they are facing."" Three items had <61% agreement and Poor PABAK: ""I feel a sense of harmony within myself,"" ""My illness has strengthened my faith or spiritual beliefs,"" ""I feel connected to a higher power (or God)."" Dyadic congruence was compared by social-demographics using median one-way analysis. Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
CONCLUSIONS


Family members may not share spiritual beliefs with adolescents and may be unaware of the importance of spiritual well-being for adolescents.",2020,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","['teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads', 'adolescents with cancer and their families', 'Adolescents (126) had mean age of 16.9\xa0years, were 57% female and 79% White']","['FAmily CEntered (FACE', 'FACE']","['Dyadic congruence', 'prevalence-adjusted and bias-adjusted kappa (PABAK']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",126.0,0.0242359,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Livingston', 'Affiliation': 'Grant Thornton LLP, Arlington, Virginia.'}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': 'Strategic Innovative Solutions LLC, Petersburg, Florida.'}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tweddle', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': ""Department of Oncology and Division of Quality of Life and Palliative Care, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research/Children's National Research Institute at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.'}]",Pediatric blood & cancer,['10.1002/pbc.28696']
2864,32918555,Bone marrow stimulation for talar osteochondral lesions at long-term follow-up shows a high sports participation though a decrease in clinical outcomes over time.,"PURPOSE


Although bone marrow stimulation (BMS) as a treatment for osteochondral lesions of the talus (OCLT) shows high rates of sport resumption at short-term follow-up, it is unclear whether the sports activity is still possible at longer follow-up. The purpose of this study was, therefore, to evaluate sports activity after arthroscopic BMS at long-term follow-up.
METHODS


Sixty patients included in a previously published randomized-controlled trial were analyzed in the present study. All patients had undergone arthroscopic debridement and BMS for OCLT. Return to sports, level, and type were assessed in the first year post-operative and at final follow-up. Secondary outcome measures were assessed by standardized questionnaires with use of numeric rating scales for pain and satisfaction and the Foot and Ankle Outcome Score (FAOS).
RESULTS


The mean follow-up was 6.4 years (SD ± 1.1 years). The mean level of activity measured with the AAS was 6.2 pre-injury and 3.4 post-injury. It increased to 5.2 at 1 year after surgery and was 5.8 at final follow-up. At final follow-up, 54 patients (90%) participated in 16 different sports. Thirty-three patients (53%) indicated they returned to play sport at their pre-injury level. Twenty patients (33%) were not able to obtain their pre-injury level of sport because of ankle problems and eight other patients (13%) because of other reasons. Mean NRS for pain during rest was 2.7 pre-operative, 1.1 at 1 year, and 1.0 at final follow-up. Mean NRS during activity changed from 7.9 to 3.7 to 4.4, respectively. The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up.
CONCLUSION


At long-term follow-up (mean 6.4 years) after BMS for OCLT, 90% of patients still participate in sports activities, of whom 53% at pre-injury level. The AAS of the patients participating in sports remains similar pre-injury and post-operatively at final follow-up. A decrease over time in clinical outcomes was, however, seen when the follow-up scores at 1 year post-operatively were compared with the final follow-up.
LEVEL OF EVIDENCE


Level II.",2020,"The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up.
","['Sixty patients', 'All patients had undergone arthroscopic debridement and BMS for OCLT', '54 patients (90%) participated in 16 different sports']","['bone marrow stimulation (BMS', 'Bone marrow stimulation']","['mean level of activity', 'Mean NRS during activity', 'Mean NRS for pain', 'standardized questionnaires with use of numeric rating scales for pain and satisfaction and the Foot and Ankle Outcome Score (FAOS', 'FAOS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0488496,"The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up.
","[{'ForeName': 'Kaj T A', 'Initials': 'KTA', 'LastName': 'Lambers', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Dahmen', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.'}, {'ForeName': 'J Nienke', 'Initials': 'JN', 'LastName': 'Altink', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Reilingh', 'Affiliation': 'Academic Center for Evidence Based Sports Medicine (ACES), Amsterdam, The Netherlands.'}, {'ForeName': 'Christiaan J A', 'Initials': 'CJA', 'LastName': 'van Bergen', 'Affiliation': 'Academic Center for Evidence Based Sports Medicine (ACES), Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam Movement Sciences, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands. g.m.kerkhoffs@amsterdamumc.nl.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06250-8']
2865,32919381,Overspeed Stimulus Provided by Assisted Jumping Encourages Rapid Increases in Strength and Power Performance of Older Adults.,"Following a 4-week control period, 24 older men and women (55-91 years) attended a 4-week progressive jumping program to determine whether assisted jumping could be safely and effectively implemented as a novel stimulus in healthy older adults. Bodyweight countermovement jump performance, isometric and isokinetic strength, postural stability, and exercise enjoyment were assessed before the control period, before the training intervention, and after the training intervention. Following the 4-week intervention, eccentric quadriceps strength increased by 19 N·m (95% confidence interval [2, 36], p = .013), bodyweight countermovement jump height increased by 1.7 cm (95% CI [0.5, 2.9], p < .001), postural sway improved by 2.1 mm/s (95% CI [0.3, 4.0], p = .026), and the participants' perceived exercise enjoyment improved (p = .026). Therefore, using assisted jumping to induce an overspeed training stimulus in a jump training program resulted in similar performance improvements as in previous studies in older populations but with less training volume and a shorter training duration.",2020,"Bodyweight countermovement jump performance, isometric and isokinetic strength, postural stability, and exercise enjoyment were assessed before the control period, before the training intervention, and after the training intervention.","['24 older men and women (55-91\xa0years', 'Older Adults', 'healthy older adults']",[],"['Strength and Power Performance', 'eccentric quadriceps strength', 'Bodyweight countermovement jump performance, isometric and isokinetic strength, postural stability, and exercise enjoyment', 'exercise enjoyment', 'bodyweight countermovement jump height', 'postural sway']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0439740', 'cui_str': 'Eccentric'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",24.0,0.0684599,"Bodyweight countermovement jump performance, isometric and isokinetic strength, postural stability, and exercise enjoyment were assessed before the control period, before the training intervention, and after the training intervention.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Vetrovsky', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Omcirk', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Malecek', 'Affiliation': ''}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastny', 'Affiliation': ''}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Steffl', 'Affiliation': ''}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0012']
2866,32919383,Implementation of a School Physical Activity Policy Improves Student Physical Activity Levels: Outcomes of a Cluster-Randomized Controlled Trial.,"AIM


To assess the impact of a multistrategy intervention designed to improve teachers' implementation of a school physical activity (PA) policy on student PA levels.
METHODS


A cluster-randomized controlled trial was conducted in 12 elementary schools. Policy implementation required schools to deliver 150 minutes of organized PA for students each week via physical education, sport, or class-based activities such as energizers. Schools received implementation support designed using the theoretical domains framework to help them implement the current policy.
RESULTS


A total of 1,502 children in kindergarten to grade 6 participated. At follow-up compared with control, students attending intervention schools had, measured via accelerometer, significantly greater increases in school day counts per minute (97.5; 95% confidence interval [CI], 64.5 to 130.4; P < .001) and moderate to vigorous physical activity (MVPA) (3.0; 95% CI, 2.2-3.8, P < .001) and a greater decrease in sedentary time (-2.1; 95% CI, -3.9 to -0.4, P = .02) per school day. Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7-70.5, P = .04).
CONCLUSIONS


Supporting teachers to implement a PA policy improves student PA. Additional strategies may be needed to support teachers to implement activities that result in larger gains in student MVPA.",2020,"Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7-70.5, P = .04).
","['1,502 children in kindergarten to grade 6 participated', '12 elementary schools']","['School Physical Activity Policy', 'school physical activity (PA) policy', 'multistrategy intervention']","['sedentary time', 'moderate to vigorous physical activity\xa0(MVPA', 'school day counts per minute']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392412', 'cui_str': 'cpm'}]",1502.0,0.142183,"Teachers in intervention schools delivered significantly more minutes (36.6 min) of PA to their students at follow-up (95% CI, 2.7-70.5, P = .04).
","[{'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Nathan', 'Affiliation': ''}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Sutherland', 'Affiliation': ''}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Hope', 'Affiliation': ''}, {'ForeName': 'Nicole J', 'Initials': 'NJ', 'LastName': 'McCarthy', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Pettett', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Elton', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': ''}, {'ForeName': 'Stewart G', 'Initials': 'SG', 'LastName': 'Trost', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': ''}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Reilly', 'Affiliation': ''}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': ''}, {'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gillham', 'Affiliation': ''}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Herrmann', 'Affiliation': ''}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0595']
2867,32919388,Preterm children's long-term academic performance after adaptive computerized training: an efficacy and process analysis of a randomized controlled trial.,"BACKGROUND


Adaptive computerized interventions may help improve preterm children's academic success, but randomized trials are rare. We tested whether a math training (XtraMath®) versus an active control condition (Cogmed®; working memory) improved school performance. Training feasibility was also evaluated.
METHODS


Preterm born first graders, N = 65 (28-35 + 6 weeks gestation) were recruited into a prospective randomized controlled multicenter trial and received one of two computerized trainings at home for 5 weeks. Teachers rated academic performance in math, reading/writing, and attention compared to classmates before (baseline), directly after (post), and 12 months after the intervention (follow-up). Total academic performance growth was calculated as change from baseline (hierarchically ordered-post test first, follow-up second).
RESULTS


Bootstrapped linear regressions showed that academic growth to post test was significantly higher in the math intervention group (B = 0.25 [95% confidence interval: 0.04-0.50], p = 0.039), but this difference was not sustained at the 12-month follow-up (B = 0.00 [-0.31 to 0.34], p = 0.996). Parents in the XtraMath group reported higher acceptance compared with the Cogmed group (mean difference: -0.49, [-0.90 to -0.08], p = 0.037).
CONCLUSIONS


Our findings do not show a sustained difference in efficacy between both trainings. Studies of math intervention effectiveness for preterm school-aged children are warranted.
IMPACT


Adaptive computerized math training may help improve preterm children's short-term school performance.Computerized math training provides a novel avenue towards intervention after preterm birth.Well-powered randomized controlled studies of math intervention effectiveness for preterm school-aged children are warranted.Fig. 1RANDOMIZATION FLOW CHART.: Note. HIE hypoxic-ischemic encephalopathy, PVL periventricular leukomalacia, IVH intraventricular hemorrhage, ODD oppositional defiant disorder.Fig. 2TEACHER-RATED ACADEMIC ATTAINMENT SCORES (TAAS) BY INTERVENTION GROUP (XTRAMATH (N = 29, BOLDED) VERSUS COGMED (N = 27)) AT BASELINE, POST TEST, AND 12 MONTHS FOLLOW-UP.: Note: Bolded bars represent the XtraMath intervention group.Fig. 3MATH TEST SCORES (DEMAT) BY INTERVENTION GROUP (XTRAMATH (N = 28, BOLDED) VERSUS COGMED (N = 25)) AT BASELINE, POST TEST, AND 12 MONTHS FOLLOW-UP.: Note: Bolded bars represent the XtraMath intervention group.",2020,"Parents in the XtraMath group reported higher acceptance compared with the Cogmed group (mean difference: -0.49, [-0.90 to -0.08], p = 0.037).
","['preterm school-aged children', 'Preterm born first graders, N\u2009=\u200965 (28-35\u2009+\u20096 weeks gestation', 'N\u2009=\u200927', ""preterm children's academic success""]","['IMPACT\n\n\nAdaptive computerized math training', 'math training (XtraMath®) versus an active control condition (Cogmed®; working memory', 'Computerized math training', 'GROUP (XTRAMATH (N\u2009=\u200929, BOLDED) VERSUS COGMED', 'adaptive computerized training']","['HIE hypoxic-ischemic encephalopathy, PVL periventricular leukomalacia, IVH intraventricular hemorrhage, ODD oppositional defiant disorder', 'higher acceptance', ""preterm children's short-term school performance"", 'school performance', 'Teachers rated academic performance in math, reading/writing, and attention compared to classmates', 'academic growth to post test', 'Total academic performance growth', ""Preterm children's long-term academic performance""]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700132', 'cui_str': 'Academic Achievement'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0023529', 'cui_str': 'Periventricular leukomalacia'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0029121', 'cui_str': 'Oppositional defiant disorder'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",,0.290526,"Parents in the XtraMath group reported higher acceptance compared with the Cogmed group (mean difference: -0.49, [-0.90 to -0.08], p = 0.037).
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Jaekel', 'Affiliation': 'Child and Family Studies, University of Tennessee Knoxville, Knoxville, TN, USA. jjaekel@utk.edu.'}, {'ForeName': 'Katharina M', 'Initials': 'KM', 'LastName': 'Heuser', 'Affiliation': 'Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Medical Biometry and Epidemiology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': ""Vest Children's Hospital Datteln, University Witten-Herdecke, Datteln, Germany.""}, {'ForeName': 'Francisco Brevis', 'Initials': 'FB', 'LastName': 'Nuñez', 'Affiliation': 'Pädiatrische Intensivmedizin, Sana-Kliniken Duisburg, Duisburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bartmann', 'Affiliation': ""Children's Hospital, University Hospital Bonn, Bonn, Germany.""}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Wolke', 'Affiliation': 'Department of Psychology, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Felderhoff-Mueser', 'Affiliation': 'Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Huening', 'Affiliation': 'Pediatrics I, Neonatology, Pediatric Intensive Care, Pediatric Neurology, University Hospital Essen, Essen, Germany.'}]",Pediatric research,['10.1038/s41390-020-01114-w']
2868,32919400,"Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial.","Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.Fig. 1FLOWCHART SHOWING 3 PHASES OF THE STUDY.: TMS indicates transcranial magnetic stimulation.Fig. 2Primary efficacy outcome.",2020,Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95).,"['Adolescents with TRD (aged 12-21 years', 'adolescents with TRD.Fig', 'adolescents with TRD', 'Intention-to-treat patients (n\u2009=\u2009103', 'adolescents']","['active NeuroStar TMS monotherapy (n\u2009=\u200948) or sham TMS', '10-Hz transcranial magnetic stimulation (TMS', 'TMS', 'Left prefrontal transcranial magnetic stimulation']","['depressive symptom severity', 'Response rates', 'Remission rates', 'least-squares mean (SE) HAM-D-24 scores', 'new tolerability or safety signals', 'Hamilton Depression Rating Scale (HAM-D-24) score', 'transcranial magnetic stimulation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",,0.481603,Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95).,"[{'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Croarkin', 'Affiliation': 'Division of Child and Adolescent Psychiatry and Psychology and Mayo Clinic Depression Center, Mayo Clinic, Rochester, MN, USA. croarkin.paul@mayo.edu.'}, {'ForeName': 'Ahmed Z', 'Initials': 'AZ', 'LastName': 'Elmaadawi', 'Affiliation': 'Beacon Health System, South Bend, IN, USA.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, Maryland; Integrative Psychiatry, Louisville, KY, USA.'}, {'ForeName': 'G Randolph', 'Initials': 'GR', 'LastName': 'Schrodt', 'Affiliation': 'Sheppard Pratt Health System, Baltimore, Maryland; Integrative Psychiatry, Louisville, KY, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Holbert', 'Affiliation': 'Shands Psychiatric Hospital, Gainesville, Florida; North American Science Associates, Inc. (NAMSA), Minneapolis, MN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Verdoliva', 'Affiliation': 'Shands Psychiatric Hospital, Gainesville, Florida; North American Science Associates, Inc. (NAMSA), Minneapolis, MN, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Heart', 'Affiliation': 'Neuronetics, Inc, Malvern, PA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Trevena, Inc, Chesterbrook, PA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': ""Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00829-y']
2869,31264493,Myosteatosis in adolescents and young adults treated for acute lymphoblastic leukemia.,"Myosteatosis refers to fat deposition within muscle and is linked to risk of cardiovascular disease and metabolic disorders. Though these comorbidities are common during and after therapy for acute lymphoblastic leukemia (ALL), little is known about tissue distribution, including myosteatosis, in this population. Using quantitative computed tomography, we assessed the impact of ALL therapy on bone, muscle, subcutaneous, and muscle-associated (MA) fat in 12 adolescents and young adults (AYA) treated for ALL as compared to a healthy control group without ALL ( n  = 116). AYA had a marked loss of muscle with a gain in MA fat between ALL diagnosis and end of induction. These changes persisted throughout intensive therapy. Lower bone and muscle and higher MA fat were also observed during and after treatment in comparison to controls. Altered lower extremity tissue distribution, specifically myosteatosis and sarcopenia, may contribute to functional declines and increased risk of metabolic disorders and cardiovascular diseases.",2019,Lower bone and muscle and higher MA fat were also observed during and after treatment in comparison to controls.,"['adolescents and young adults treated for acute lymphoblastic leukemia', 'acute lymphoblastic leukemia (ALL', '12 adolescents and young adults (AYA) treated for ALL as compared to a healthy control group without ALL ( n \u2009=\u2009116']",[],"['bone, muscle, subcutaneous, and muscle-associated (MA) fat', 'Lower bone and muscle and higher MA fat']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0181417,Lower bone and muscle and higher MA fat were also observed during and after treatment in comparison to controls.,"[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Mueske', 'Affiliation': ""Children's Orthopaedic Center, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tishya A L', 'Initials': 'TAL', 'LastName': 'Wren', 'Affiliation': ""Children's Orthopaedic Center, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Gilsanz', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Etan', 'Initials': 'E', 'LastName': 'Orgel', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1623889']
2870,31905885,"Pasta Consumption and Connected Dietary Habits: Associations with Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors in People with Type 2 Diabetes-TOSCA.IT Study.","BACKGROUND


Pasta is a refined carbohydrate with a low glycemic index. Whether pasta shares the metabolic advantages of other low glycemic index foods has not really been investigated. The aim of this study is to document, in people with type-2 diabetes, the consumption of pasta, the connected dietary habits, and the association with glucose control, measures of adiposity, and major cardiovascular risk factors.
METHODS


We studied 2562 participants. The dietary habits were assessed with the European Prospective Investigation into Cancer and Nutrition (EPIC) questionnaire. Sex-specific quartiles of pasta consumption were created in order to explore the study aims.
RESULTS


A higher pasta consumption was associated with a lower intake of proteins, total and saturated fat, cholesterol, added sugar, and fiber. Glucose control, body mass index, prevalence of obesity, and visceral obesity were not significantly different across the quartiles of pasta intake. No relation was found with LDL cholesterol and triglycerides, but there was an inverse relation with HDL-cholesterol. Systolic blood pressure increased with pasta consumption; but this relation was not confirmed after correction for confounders.
CONCLUSIONS


In people with type-2 diabetes, the consumption of pasta, within the limits recommended for total carbohydrates intake, is not associated with worsening of glucose control, measures of adiposity, and major cardiovascular risk factors.",2019,"A higher pasta consumption was associated with a lower intake of proteins, total and saturated fat, cholesterol, added sugar, and fiber.","['2562 participants', 'People with Type 2 Diabetes-TOSCA.IT Study', 'people with type-2 diabetes']",['Pasta Consumption and Connected Dietary Habits'],"['Glucose Control, Adiposity Measures, and Cardiovascular Risk Factors', 'Glucose control, body mass index, prevalence of obesity, and visceral obesity', 'Systolic blood pressure', 'LDL cholesterol and triglycerides', 'HDL-cholesterol', 'lower intake of proteins, total and saturated fat, cholesterol, added sugar, and fiber']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C2936179', 'cui_str': 'Visceral Obesity'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]",2562.0,0.0274135,"A higher pasta consumption was associated with a lower intake of proteins, total and saturated fat, cholesterol, added sugar, and fiber.","[{'ForeName': 'Marilena', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Masulli', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Angela Albarosa', 'Initials': 'AA', 'LastName': 'Rivellese', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Bonora', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University and Hospital Trust of Verona, 37138 Verona, Italy.'}, {'ForeName': 'Anna Carla', 'Initials': 'AC', 'LastName': 'Babini', 'Affiliation': 'Medical Division, Rimini Hospital, 47900 Rimini, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sartore', 'Affiliation': 'Dipartimento di Medicina, University of Padova, 35100 Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Corsi', 'Affiliation': 'Dipartimento di Diabetologia e Malattie del Metabolismo, ASL 4 Chiavarese, 16043 Genova, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Buzzetti', 'Affiliation': 'Department of Experimental Medicine, Sapienza University, 04100 Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Citro', 'Affiliation': 'UO Endocrinologia e Diabetologia, ASP, 85100 Potenza, Italy.'}, {'ForeName': 'Maria Pompea Antonia', 'Initials': 'MPA', 'LastName': 'Baldassarre', 'Affiliation': ""CeSI-MeT-Centro di Scienze dell'Invecchiamento e Medicina Traslazionale-University G. D'Annunzio of Chieti, 66100 Pescara, Italy.""}, {'ForeName': 'Antonio Carlo', 'Initials': 'AC', 'LastName': 'Bossi', 'Affiliation': 'UOC Malattie Endocrine e Centro Regionale per il Diabete Mellito, ASST Bergamo Ovest di Treviglio, 24047 Treviglio, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Giordano', 'Affiliation': 'Section of Endocrinology, Diabetology and Metabolic Diseases, University of Palermo, 90127 Palermo, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Auciello', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': ""Dall'Aglio"", 'Affiliation': 'Dipartimento di Medicina Clinica e Sperimentale, University of Parma, 43100 Parma, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Iannarelli', 'Affiliation': ""UOSD Diabetologia e Malattie del Metabolismo, Ospedale San Salvatore, 67100 L'Aquila, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tonutti', 'Affiliation': 'SOC di Endocrinologia e Malattie del Metabolismo, AOU S. Maria della Misericordia, 33100 Udine, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Sacco', 'Affiliation': 'Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), 65124 Pescara, Italy.'}, {'ForeName': 'Graziano', 'Initials': 'G', 'LastName': 'Di Cianni', 'Affiliation': 'UOC Diabetologia, ASL 6, 57100 Livorno, Italy.'}, {'ForeName': 'Gennaro', 'Initials': 'G', 'LastName': 'Clemente', 'Affiliation': 'IRPPS Research National Council, Penta di Fisciano, 84025 Salerno, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Gregori', 'Affiliation': 'SSD Diabetologia, ASL 1, 54100 Massa Carrara, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Grioni', 'Affiliation': 'Unità di Epidemiologia e Prevenzione, Fondazione IRCCS, Istituto Nazionale Tumori, 20133 Milano, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Krogh', 'Affiliation': 'Unità di Epidemiologia e Prevenzione, Fondazione IRCCS, Istituto Nazionale Tumori, 20133 Milano, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Riccardi', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Vaccaro', 'Affiliation': 'Department of Clinical Medicine and Surgery, University of Naples Federico II, 80131 Naples, Italy.'}]",Nutrients,['10.3390/nu12010101']
2871,31935783,Impact of Priming on Effectiveness of TMS in Detecting Language-eloquent Brain Areas in Tumor Patients.,"BACKGROUND AND STUDY AIMS


Language is characteristically human, and preserving it is critical when resecting tumors in language-eloquent brain areas. Navigated repetitive transcranial magnetic stimulation (nrTMS) has been used in recent years as a noninvasive technique to identify preoperatively the language-eloquent cortical areas in tumor patients. An important objective is to increase the sensitivity and specificity of nrTMS in detecting language-related areas and increase the positive correlation of its results to that of intraoperative direct cortical stimulation (DCS). Although the technical aspects of the procedure have received enormous interest, factors related to the targeted cortical area such as previous cortical history or activity have been neglected. Therefore, the present study explores the impact of previous cortical history or activity on the effectiveness of a subsequent nrTMS mapping paradigm.
MATERIALS AND METHODS


Twelve right-handed patients with a left hemispheric glioma underwent presurgical nrTMS language mapping and intraoperative language mapping with DCS. nrTMS was performed using a continuous theta burst stimulation paradigm to inhibit possible language relevant areas in the vicinity of the tumor, determined anatomically or based on functional magnetic resonance imaging hotspots. The nrTMS was applied in two separate sessions. One of the sessions randomly included a priming paradigm to precondition the targeted cortical areas.
RESULTS


Priming stimulation decreased the error detection of the subsequent nrTMS mapping paradigm. This effect was more robust on major types of errors such as speech arrest and hesitation.
CONCLUSION


Prior cortical activity as induced by the priming stimulation has a profound impact on the responsiveness to the nrTMS mapping paradigm. Our findings further showed that metaplasticity, a type of homeostatic plastic process, could be elicited even in cortical areas affected by a growing tumor.",2020,Twelve right-handed patients with a left hemispheric glioma underwent presurgical nrTMS language mapping and intraoperative language mapping with DCS.,"['Tumor Patients', 'Twelve right-handed patients with a left hemispheric glioma underwent']","['Navigated repetitive transcranial magnetic stimulation (nrTMS', 'presurgical nrTMS language mapping and intraoperative language mapping with DCS', 'TMS']",['error detection'],"[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",12.0,0.0265336,Twelve right-handed patients with a left hemispheric glioma underwent presurgical nrTMS language mapping and intraoperative language mapping with DCS.,"[{'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Freigang', 'Affiliation': 'Department of Neurosurgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Fresnoza', 'Affiliation': 'Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Kariem', 'Initials': 'K', 'LastName': 'Mahdy Ali', 'Affiliation': 'Department of Neurosurgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Zaar', 'Affiliation': 'Department of Neurosurgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Jehna', 'Affiliation': 'Department of Radiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Reishofer', 'Affiliation': 'Department of Radiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Rammel', 'Affiliation': 'Department of Neurosurgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Studencnik', 'Affiliation': 'Department of Radiology, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Ischebeck', 'Affiliation': 'Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Gord', 'Initials': 'G', 'LastName': 'von Campe', 'Affiliation': 'Department of Neurosurgery, Medical University of Graz, Graz, Austria.'}]","Journal of neurological surgery. Part A, Central European neurosurgery",['10.1055/s-0039-1698382']
2872,32918391,A Laboratory-Based Study of the Priming Effects of Food Cues and Stress on Hunger and Food Intake in Individuals with Obesity.,"OBJECTIVE


This study aimed to assess the effects of exposures to food cues and stress on hunger and food intake and examine whether cue responses differ by weight status.
METHODS


In a laboratory-based experimental study, participants (n = 138) were exposed to stress, neutral, and food cues delivered using an individualized script-driven imagery task on three separate days. After each cue exposure, participants ate high- and low-calorie snack foods ad libitum (Food Snack Test). Hunger was measured by visual analog scales.
RESULTS


Food cues elicited significantly greater increases in hunger compared with neutral and stress stimuli. Cue-induced hunger did not differ by weight status. Participants consumed a similar number of total calories across stimuli. In response to food cue provocation, participants with obesity consumed [mean (SE)] 81.0% (4.0%) of calories from high-calorie foods, which was significantly greater than participants with normal weight (63.5%  [3.6%]; P = 0.001). After the stress cue, participants with obesity consumed 81.4% (4.0%) of calories from high-calorie foods, which was significantly more than participants with normal weight (70.2% [3.6%]; P = 0.04). Energy intake from high-calorie foods did not differ by weight status after the neutral cue.
CONCLUSIONS


Among individuals with obesity, exposure to food and stress cues shifted consumption to high-calorie snack foods within a well-controlled experimental setting.",2020,Cue-induced hunger did not differ by weight status.,"['participants (n\u2009=\u2009138', 'Individuals with Obesity']","['Food Cues and Stress', 'stress, neutral, and food cues delivered using an individualized script-driven imagery task']","['Cue-induced hunger', 'Hunger', 'weight status', 'hunger compared with neutral and stress stimuli', 'Hunger and Food Intake', 'normal weight']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]",138.0,0.0895217,Cue-induced hunger did not differ by weight status.,"[{'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nia', 'Initials': 'N', 'LastName': 'Fogelman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Grilo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Rajita', 'Initials': 'R', 'LastName': 'Sinha', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22952']
2873,32918419,Improving cardiopulmonary resuscitation (CPR) performance using an audio-visual feedback device for healthcare providers in an emergency department setting in Malaysia: a quasi-experimental study.,"INTRODUCTION


Cardiopulmonary Resuscitation (CPR) remains the primary mechanism of resuscitation for cardiac arrest victims. However, the quality of delivery of CPR varies widely in different settings, possibly affecting patient outcomes. This study is aimed to determine the efficacy of an audio-visual (AV) CPR feedback device in improving the quality of CPR delivered by healthcare providers.
METHODS


This pre-post, single-arm, quasi-experimental study randomly sampled 140 healthcare providers working in the Emergency Department of Hospital Ampang, Malaysia. Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device. The efficacy of the AV CPR feedback device was assessed using the Chi-square test and Generalised Estimating Equations (GEE) models.
RESULTS


The use of an AV CPR feedback device increased the proportion of healthcare providers achieving recommended depth of chest compressions from 38.6% (95% Confidence Interval, 95%CI: 30.5, 47.2) to 85.0% (95%CI: 78.0, 90.5). A similar significant improvement from 39.3% (95%CI: 31.1, 47.9) to 86.4% (95%CI: 79.6, 91.6) in the recommended rate of chest compressions was also observed. Use of the AV CPR device significantly increased the likelihood of a CPR provider achieving recommended depth of chest compressions (Odds Ratio, OR=13.01; 95%CI: 7.12, 24.01) and rate of chest compressions (OR=13.00; 95%CI: 7.21, 23.44).
CONCLUSION


The use of an AV CPR feedback device significantly improved the delivered rate and depth of chest compressions closer to American Heart Association (AHA) recommendations. Usage of such devices within real-life settings may help in improving the quality of CPR for patients receiving CPR.",2020,"Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device.","['patients receiving CPR', '140 healthcare providers working in the Emergency Department of Hospital Ampang, Malaysia', 'healthcare providers in an emergency department setting in Malaysia']","['AV CPR feedback device', 'cardiopulmonary resuscitation (CPR) performance using an audio-visual feedback device', 'AV CPR device', 'Cardiopulmonary Resuscitation (CPR', 'audio-visual (AV) CPR feedback device']","['rate of chest compressions', 'AV CPR feedback device', 'CPR quality, namely chest compression rate and depth', 'quality of CPR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0183001', 'cui_str': 'Cardiopulmonary resuscitator'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",140.0,0.03837,"Parameters of CPR quality, namely chest compression rate and depth were compared among participants when they performed CPR with and without an AV CPR feedback device.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chelladurai', 'Affiliation': 'Hospital Ampang, Selangor, Malaysia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Noor Azhar', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mohd Isa', 'Affiliation': 'Hospital Ampang, Selangor, Malaysia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bustam', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'University of Malaya Medical Centre, Department of Emergency Medicine, Kuala Lumpur, Malaysia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Munisamy', 'Affiliation': 'Chulalongkorn University, College of Public Health Sciences, Bangkok, Thailand. murallimd@gmail.com.'}]",The Medical journal of Malaysia,[]
2874,32918434,Resistant hypertension during antituberculosis treatment: how is rifampicin implicated?,"A 67-year-old mental institute resident was treated for smear-positive pulmonary tuberculosis. His background history included chronic essential hypertension which was well-controlled with amlodipine 10mg daily. However, his blood pressure became suboptimal one week into antitubercular treatment, necessitating escalation of antihypertensive therapy up to six medications. Following completion of antitubercular treatment, his blood pressure improved markedly. The number of antihypertensives was able to be reduced to only two after a month. We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.",2020,We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.,['His background history included chronic essential hypertension'],"['amlodipine', 'rifampicin']","['number of antihypertensives', 'blood pressure']","[{'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0273169,We postulate that rifampicin has attenuated the therapeutic effect of amlodipine via potent induction of hepatic CYP3A4 but the failure to control the blood pressure even with medications unrelated to cytochrome P450 pathways raises the spectre of an additional interaction.,"[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Lee', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Lim', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Chai', 'Affiliation': 'Hospital Sultanah Aminah Johor Bahru, Department of Medicine, Johor, Malaysia. chaishuteng@gmail.com.'}]",The Medical journal of Malaysia,[]
2875,32918474,Economic Evaluation of Extended Early Intervention Service vs Regular Care Following 2 Years of Early Intervention: Secondary Analysis of a Randomized Controlled Trial.,"Cost-effectiveness studies of early intervention services (EIS) for psychosis have not included extension beyond the first 2 years. We sought to evaluate the cost-effectiveness of a 3-year extension of EIS compared to regular care (RC) from the public health care payer's perspective. Following 2 years of EIS in a university setting in Montreal, Canada, patients were randomized to a 3-year extension of EIS (n = 110) or RC (n = 110). Months of total symptom remission served as the main outcome measure. Resource use and cost data for publicly covered health care services were derived mostly from administrative systems. The incremental cost-effectiveness ratio (ICER) and cost-effectiveness acceptability curve were produced. Relative cost-effectiveness was estimated for those with duration of untreated psychosis (DUP) of 12 weeks or less vs longer. Extended early intervention had higher costs for psychiatrist and nonphysician interventions, but total costs were not significantly different. The ICER was $1627 per month in total remission. For the intervention to have an 80% chance of being cost-effective, the decision-maker needs to be willing to pay $5942 per month of total symptom remission. DUP ≤ 12 weeks was associated with a reduction in costs of $12 276 even if no value is placed on additional months in total remission. Extending EIS for psychosis for people, such as those included in this study, may be cost-effective if the decision-maker is willing to pay a high price for additional months of total symptom remission, though one commensurate with currently funded interventions. Cost-effectiveness was much greater for people with DUP ≤12 weeks.",2020,"Extended early intervention had higher costs for psychiatrist and nonphysician interventions, but total costs were not significantly different.",['Following 2 Years of Early Intervention'],"['Extended Early Intervention Service vs Regular Care', 'early intervention services (EIS', 'EIS compared to regular care (RC']","['cost-effectiveness', 'incremental cost-effectiveness ratio (ICER) and cost-effectiveness acceptability curve', 'ICER', 'Relative cost-effectiveness', 'total costs', 'Cost-effectiveness', 'total symptom remission']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.0768978,"Extended early intervention had higher costs for psychiatrist and nonphysician interventions, but total costs were not significantly different.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Groff', 'Affiliation': 'Mental Health and Society Division, Douglas Research Centre, Montreal, QC, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Latimer', 'Affiliation': 'Mental Health and Society Division, Douglas Research Centre, Montreal, QC, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Srividya N', 'Initials': 'SN', 'LastName': 'Iyer', 'Affiliation': 'Mental Health and Society Division, Douglas Research Centre, Montreal, QC, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Mental Health and Society Division, Douglas Research Centre, Montreal, QC, Canada.'}, {'ForeName': 'Sherezad', 'Initials': 'S', 'LastName': 'Abadi', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Abdel-Baki', 'Affiliation': 'University of Montreal Hospital Centre, Montreal, QC, Canada.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Casacalenda', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Margolese', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'G Eric', 'Initials': 'GE', 'LastName': 'Jarvis', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Malla', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}]",Schizophrenia bulletin,['10.1093/schbul/sbaa130']
2876,32918486,Net benefit index: Assessing the influence of a biomarker for individualized treatment rules.,"One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies. Motivated from a randomized clinical trial for Type 2 diabetic patients on a comparison of two drugs, i.e. pioglitazone and gliclazide, we consider a problem: utilizing promising candidate biomarkers to improve an existing ITR. This calls for a biomarker evaluation procedure that enables to gauge added values of individual biomarkers. We propose an assessment analytic, termed as net benefit index (NBI), that quantifies a contrast between the resulting gain and loss of treatment benefits when a biomarker enters ITR to reallocate patients in treatments. We optimize reallocation schemes via outcome weighted learning (OWL), from which the optimal treatment group labels are generated by weighted support vector machine (SVM). To account for sampling uncertainty in assessing a biomarker, we propose an NBI-based test for a significant improvement over the existing ITR, where the empirical null distribution is constructed via the method of stratified permutation by treatment arms. Applying NBI to the motivating diabetes trial, we found that baseline fasting insulin is an important biomarker that leads to an improvement over an existing ITR based only on patient's baseline fasting plasma glucose (FPG), age and body mass index (BMI) to reduce FPG over a period of 52 weeks' treatment.",2020,One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies.,['Type 2 diabetic patients'],['pioglitazone and gliclazide'],['Net benefit index'],"[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}]","[{'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0265782,One central task in precision medicine is to establish individualized treatment rules (ITRs) for patients with heterogeneous responses to different therapies.,"[{'ForeName': 'Yiwang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Peter X K', 'Initials': 'PXK', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, MI, 48109, USA.'}, {'ForeName': 'Haoda', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Eli Lilly and Company, Lilly Corperate Center, Indianapolis, IN, 46285, USA.'}]",Biometrics,['10.1111/biom.13373']
2877,32915775,Decreased Synovial Fluid Biomarkers Levels Are Associated with Rehabilitation of Function and Pain in Rotator Cuff Tear Patients Following Electroacupuncture Therapy.,"BACKGROUND The aim of this study was to assess inflammatory cytokines levels in synovial fluid (SF) before and after electroacupuncture (EA) treatment and to explore whether these biomarkers are associated with function of rotator cuff tear (RCT) patients. MATERIAL AND METHODS We recruited 54 patients with RCT and separated them into an EA group and a control group. The SF biomarker levels were detected at baseline and at 6-week and 6-month follow-up. The symptomatic severity was evaluated by visual analog scale (VAS), Constant-Murley score, and American Shoulder and Elbow Surgeons score (ASES). We also investigated the correlation between symptomatic severity and biomarker levels in SF of the shoulder joint. RESULTS The reductions in VAS and improved functional score (ASES and Constant-Murley score) were significantly different between the 2 groups, and SF biomarker concentrations were significantly lower in the EA group. IL-1ß levels were significantly negatively correlated with Constant-Murley score (r=-0.73, P=0.04) and ASES score (r=-0.59, P<0.001) and positively correlated with VAS scores (r=0.81, P=0.004). IL-6 levels were significantly negatively correlated with Constant-Murley score (r=-0.67, P=0.03) and positively correlated with VAS score (r=0.7, P=0.01). MMP-1 levels were significantly negatively correlated with ASES score (r=-0.57, P<0.001). CONCLUSIONS The biomarkers in SF were directly associated with shoulder pain and shoulder function in rotator cuff tear. EA, as a safe and effective conservative therapy, obviously decreased the level of inflammatory cytokines in RCT patients, accompanied by a reduction in shoulder pain and improved function.",2020,"The reductions in VAS and improved functional score (ASES and Constant-Murley score) were significantly different between the 2 groups, and SF biomarker concentrations were significantly lower in the EA group.","['Rotator Cuff Tear Patients Following Electroacupuncture Therapy', '54 patients with RCT and separated them into an EA group and a control group', 'rotator cuff tear (RCT) patients']",['electroacupuncture (EA'],"['Constant-Murley score', 'SF biomarker levels', 'VAS scores', 'ASES score', 'shoulder pain and improved function', 'VAS score', 'SF biomarker concentrations', 'MMP-1 levels', 'visual analog scale (VAS), Constant-Murley score, and American Shoulder and Elbow Surgeons score (ASES', 'IL-1ß levels', 'symptomatic severity', 'level of inflammatory cytokines', 'reductions in VAS and improved functional score (ASES and Constant-Murley score', 'IL-6 levels']","[{'cui': 'C0263912', 'cui_str': 'Rotator cuff syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039097', 'cui_str': 'Synovial fluid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2001899', 'cui_str': 'MMP1 protein, human'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",54.0,0.0319419,"The reductions in VAS and improved functional score (ASES and Constant-Murley score) were significantly different between the 2 groups, and SF biomarker concentrations were significantly lower in the EA group.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Wei-Qiang', 'Initials': 'WQ', 'LastName': 'Geng', 'Affiliation': ""Department of Orthopedic Surgery, No. 980 Hospital, Joint Logistics Support Force People's Liberation Army (PLA), Handan Campus of Bethune International Hospital, Handan, Hebei, China (mainland).""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Guang-Yuan', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'Luo-Bin', 'Initials': 'LB', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedic Surgery, Third Hospital of Shijiazhuang, Shijiazhuang, Hebei, China (mainland).'}, {'ForeName': 'You-Jie', 'Initials': 'YJ', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine Center, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Orthopedics, Handan Central Hospital, Handan, Hebei, China (mainland).'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine Center, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China (mainland).'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine Center, First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923240']
2878,32915800,Public stigma towards prolonged grief disorder: Does diagnostic labeling matter?,"The recent introduction of prolonged grief disorder (PGD) as a diagnostic category may cause negative social reactions (i.e. public stigma). Vignette experiments demonstrate that persons with both PGD symptoms and a PGD diagnosis elicit more public stigma than persons who experience integrated grief. However, the strength of the influence of the diagnosis itself remains unclear: We aimed to clarify if the diagnostic label PGD produces additional public stigma beyond PGD symptoms. We further compared whether public stigma varies between the label PGD and the label major depressive episode (MDE) (when PGD symptoms are present) and if gender of the bereaved person influences public stigma or moderates the aforementioned effects. Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief). Following the vignettes, participants indicated which negative characteristics they ascribed to the person, their emotional reactions, and preferred social distance from the person. People with PGD symptoms and PGD (or MDE) diagnosis were attributed more negative characteristics, and elicited more negative emotions and a stronger desire for social distance than people with integrated grief. However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms. Gender of the bereaved only had an influence on desired social distance, which was larger towards men. Helping severely distressed bereaved people (regardless of diagnostic status) cope with negative social reactions may help them adapt to bereavement. Results demonstrate that the experience of severe grief reactions, yet not a diagnostic label per se, causes public stigma.",2020,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","['Public stigma towards prolonged grief disorder', 'persons with both PGD symptoms', 'People with PGD symptoms and PGD (or MDE) diagnosis', 'Eight-hundred fifty-two participants (77% female; Mage = 32.6 years, SD = 13.3) were randomly assigned to read online one of eight vignettes describing either a bereaved male or female, with PGD symptoms and PGD diagnosis; PGD symptoms and MDE diagnosis; PGD symptoms and no diagnosis, or no PGD symptoms and no diagnosis (i.e., integrated grief']",[],"['public stigma', 'severe grief reactions']","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C4511668', 'cui_str': 'Prolonged grief disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0560182', 'cui_str': 'Diagnosis not made'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}]",852.0,0.0295721,"However, public stigma did not differ for people with both PGD symptoms and diagnosis compared to people only experiencing PGD symptoms.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gonschor', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Maarten C', 'Initials': 'MC', 'LastName': 'Eisma', 'Affiliation': 'Department of Clinical Psychology and Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Barke', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}, {'ForeName': 'Bettina K', 'Initials': 'BK', 'LastName': 'Doering', 'Affiliation': 'Clinical and Biological Psychology, Department of Psychology, Catholic University Eichstaett-Ingolstadt, Eichstaett, Germany.'}]",PloS one,['10.1371/journal.pone.0237021']
2879,32915843,Derivation and validation of the J-CTO extension score for pre-procedural prediction of major adverse cardiac and cerebrovascular events in patients with chronic total occlusions.,"We developed a prediction model of long-term risk after percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) based on pre-procedural clinical information. A total of 4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included. Specifically, 1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups. Major adverse cardiac and cardiovascular event (MACCE) was the primary endpoint, including death, stroke, revascularization, and non-fatal myocardial infarction. We assessed the performance of our model using the area under the receiver operating characteristic curve (AUC) and assigned a simplified point-scoring system. One-hundred-thirty-eight (10.8%) patients experienced MACCE in the derivation cohort with hemodialysis (HD: odds ratio [OR] = 2.55), left ventricular ejection fractions (LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72). The AUC of the derivation model was 0.650. The model's performance was similar in the validation cohort (AUC, 0.610). When assigned a point for each associated factor (HD = 3, LVEF <35%, ISO = 2, and DM = 1 point), the average predicted versus the observed MACCE probability using the Japan-CTO extension score for the low, moderate, high, and very high risk groups was 8.1% vs. 7.3%, 16.9% vs. 15.9%, 22.0% vs. 26.1%, and 56.2% vs. 44.4%, respectively. This novel risk model may allow for the estimation of long-term risk and be useful in disseminating appropriate revascularization procedures.",2020,"The model's performance was similar in the validation cohort (AUC, 0.610).","['1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups', 'LVEF) <35% (OR = 2.23), in-stent occlusions (ISO: OR = 2.27), and diabetes mellitus (DM: OR = 1.72', '4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included', 'patients with chronic total occlusions']",['percutaneous coronary intervention (PCI'],"['left ventricular ejection fractions', 'death, stroke, revascularization, and non-fatal myocardial infarction', 'observed MACCE probability using the Japan-CTO extension score', 'Major adverse cardiac and cardiovascular event (MACCE', 'coronary chronic total occlusion (CTO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0919560', 'cui_str': 'Stent occlusion'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517513', 'cui_str': '1.72'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4139.0,0.0277774,"The model's performance was similar in the validation cohort (AUC, 0.610).","[{'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Ebisawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': 'Cardiovascular Center, Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Kashima', 'Affiliation': 'Division of Cardiology, Sapporo Cardio Vascular Clinic, Hokkaido, Japan.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Okamura', 'Affiliation': 'Division of Cardiology, Sakurabashi-Watanabe Hospital, Osaka, Japan.'}, {'ForeName': 'Masahisa', 'Initials': 'M', 'LastName': 'Yamane', 'Affiliation': 'Cardiology Department, Saitama Sekishinkai Hospital, Saitama, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Sakurada', 'Affiliation': 'Department of Cardiology, Tokorozawa Heart Center, Saitama, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Matsuno', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'Mikihiro', 'Initials': 'M', 'LastName': 'Kijima', 'Affiliation': 'Cardiology and Vascular Medicine, Hoshi General Hospital, Fukushima, Japan.'}, {'ForeName': 'Maoto', 'Initials': 'M', 'LastName': 'Habara', 'Affiliation': 'Department of Cardiovascular Medicine, Toyohashi Heart Center, Aichi, Japan.'}]",PloS one,['10.1371/journal.pone.0238640']
2880,32915891,Effect of the trajectory of exertional breathlessness on symptom recall and anticipation: A randomized controlled trial.,"BACKGROUND


Breathlessness is a major cause of physical limitation. Recalled breathlessness intensity may differ from experienced intensity and be influenced by the intensity trajectory including the 'peak-end rule'. The primary aim was to test if adding two minutes of low intensity exercise at the end of an exercise test would change the recalled breathlessness. Secondary aims included to analyse the impact of the peak and end exertional breathlessness intensity on breathlessness recall.
METHODS


Randomized controlled trial of 92 adults referred for exercise testing who were randomized (1:1), at test end, to 2 minutes of additional low intensity exercise (intervention; n = 47) or stopping at peak exertion (control; n = 45). Experienced breathlessness during the test and recalled intensity (30 min after the test) was assessed using the Borg CR10 scale.
RESULTS


Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1. There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009). Recalled exertional breathlessness was most strongly related to peak breathlessness (r2 = 0.43). When analyzed together, end breathlessness did not add any explanatory value above that of peak breathlessness.
CONCLUSION


Adding an episode of two minutes of lower exercise and breathlessness intensity at the end of an exercise test did not affect symptom recall, which was most strongly related to peak breathlessness intensity.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03468205).",2020,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","['92 adults referred for exercise testing', 'Participants were aged a mean 59 years; 61% men; 79% reported a mMRC ≥1']","['low intensity exercise', 'additional low intensity exercise (intervention; n = 47) or stopping at peak exertion']","['symptom recall and anticipation', 'peak breathlessness', 'recalled breathlessness intensity', 'Recalled breathlessness intensity', 'end breathlessness', 'Experienced breathlessness', 'Recalled exertional breathlessness', 'peak and end exertional breathlessness intensity on breathlessness recall']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444930', 'cui_str': 'End'}]",92.0,0.194385,"There was no between-group difference in recalled breathlessness intensity, 5.51 ([95% CI] 5.00 to 6.01) vs. 5.73 (5.27 to 6.20; p = 0.52) in controls, even though the intervention group had a significantly lower end breathlessness (mean difference 0.96; 0.24 to 1.67; p = 0.009).","[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Elmberg', 'Affiliation': 'Department of Clinical Physiology, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Faculty of Medicine, Lund University, Lund, Sweden.'}]",PloS one,['10.1371/journal.pone.0238937']
2881,32916063,Comparison of Glycemic Excursion Using Flash Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose.,"PURPOSE


To determine the effect of Voglibose add-on therapy on daily glycemic excursions in Indian patients with type 2 diabetes(T2DM) receiving a stable dose of metformin(Met)or metformin+sulfonylurea(Met+SU).
PATIENTS AND METHODS


T2DM patients with glycosylated hemoglobin(HbA1c) >7.0% and at least two postprandial excursions>140 mg/dL during the screening phase(visit 1/day-14±2), were enrolled in this prospective, multi-centre interventional study. The patients were randomized at visit 2(Day 0±2) to receive Voglibose 0.2 mg or 0.3 mg tablets (BID/TID) as add-on therapy to Met and Met+SU. Patients were followed at Day 14±2 (visit 3), Month 3±14 days (visit 4),14 weeks(i.e.visit 4+14 days) ±2days(visit 5) and Month 6±14 days (visit 6). Continuous glucose monitoring was performed at visits 2, 3 and 5. The study outcomes were : change in average number of glycemic excursionsy,percent time spent in glucose fluctuations, mean postprandial glucose(PPG), fasting plasma glucose(FPG), day and night time mean glucose levels from baseline to day 14 and week 14; change in mean amplitude of glycemic excursion(MAGE) from baseline to 14 weeks; and mean HbA1c level at 3 and 6 months.
RESULTS


Out of 110 patients enrolled, 101 patients(91.8%)(Met+SU+Voglibose:73 and Met+Voglibose:28) completed the study. There was a significant decrease in average number of glycemic excursions per day from baseline to day 14 in Met+Sul+Voglibose group and to week 14 in Met+Voglibose group.There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups.A significant reduction in mean PPG area under the curve and mean FPG levels from baseline to day 14 was reported in both treatment groups. MAGE also reduced from baseline to week 14. At 6 months, HbA1c was significantly lower, especially in the Met+SU+Voglibose arm.
CONCLUSION


Voglibose is useful in reducing glycemic variability and improving glycemic control in Asian Indian adults with T2DM.(CTRI/2018/04/013074).",2020,There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups.,"['Indian patients with type 2 diabetes(T2DM) receiving a stable dose of metformin(Met)or metformin+sulfonylurea(Met+SU', '110 patients enrolled, 101 patients(91.8%)(Met+SU+Voglibose:73 and Met+Voglibose:28) completed the study', 'Patients with Type 2 Diabetes Mellitus Before and After Treatment with Voglibose', 'Asian Indian adults with T2DM.(CTRI/2018/04/013074', 'T2DM patients with glycosylated hemoglobin(HbA1c) >7.0% and at least two postprandial excursions>140 mg/dL during the screening phase(visit 1/day-14±2']","['Voglibose 0.2 mg or 0.3 mg tablets (BID/TID', 'Glycemic Excursion Using Flash Continuous Glucose Monitoring']","['average number of glycemic excursionsy,percent time spent in glucose fluctuations, mean postprandial glucose(PPG), fasting plasma glucose(FPG), day and night time mean glucose levels', 'mean PPG area under the curve and mean FPG levels', 'mean amplitude of glycemic excursion(MAGE', 'average number of glycemic excursions', 'daily glycemic excursions', 'percent time spent above target glucose range', 'mean HbA1c level', 'glycemic variability']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0532578', 'cui_str': 'voglibose'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017853', 'cui_str': 'Glycosylated hemoglobin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0532578', 'cui_str': 'voglibose'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",110.0,0.0259508,There was also a significant reduction in percent time spent above target glucose range from baseline to day 14 in both treatment groups.,"[{'ForeName': 'Selvam', 'Initials': 'S', 'LastName': 'Kasthuri', 'Affiliation': 'Madras Diabetes Research Foundation, Gopalapuram, Chennai, Chennai, Tamil Nadu, India; drkasthuri@drmohans.com.'}, {'ForeName': 'Subramani', 'Initials': 'S', 'LastName': 'Poongothai', 'Affiliation': ""Dr.Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, Chennai, Tamil Nadu, India; poongothaisubramani@gmail.com.""}, {'ForeName': 'Ranjit Mohan', 'Initials': 'RM', 'LastName': 'Anjana', 'Affiliation': ""Dr.Mohan's Diabetes Specialities Centre & Madras Diabetes Research Foundation, Diabetology, No 4, Conran Smith Road, Gopalapuram, Chennai, Tamil Nadu, India, 600086; dranjana@drmohans.com.""}, {'ForeName': 'Jayvel', 'Initials': 'J', 'LastName': 'Selvakumar', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Tambaram East,, Chennai, Tamil Nadu, India; drselvakumar@drmohans.com.""}, {'ForeName': 'Subramaniam', 'Initials': 'S', 'LastName': 'Muthukumar', 'Affiliation': ""Dr. Mohan's Diabetes Specialities Centre, Anna Nagar, Chennai, Tamil Nadu, India; drmuthukumar@drmohans.com.""}, {'ForeName': 'Sengottuvel', 'Initials': 'S', 'LastName': 'Kayalvizhi', 'Affiliation': ""Dr.Mohan's Diabetes Specialities Centre, Diabetology, Chennai, Tamilnadu, India; drkayal@drmohans.com.""}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Tariq', 'Affiliation': ""Dr. Mohan's Diabetes Specialties Centre, Avadi, Chennai, Tamil Nadu, India; drtariq@drmohans.com.""}, {'ForeName': 'Evangelin', 'Initials': 'E', 'LastName': 'Honey', 'Affiliation': ""Dr. Mohan's Diabetes Specialties Centre, Porur, Chennai, Tamil Nadu, India; drhoneyevangelin@drmohans.com.""}, {'ForeName': 'Pokal Prasanna Kumar', 'Initials': 'PPK', 'LastName': 'Gupta', 'Affiliation': ""Dr.Mohan's Diabetes Specialities Centre, Daibetology, Chennai, Tamilnadu, India; drgupta@drmohans.com.""}, {'ForeName': 'Ulagamathesan', 'Initials': 'U', 'LastName': 'Venkatesan', 'Affiliation': ""Dr Mohan's Diabetes Specialities Centre Gopalapuram, 76035, Biostatistics, Chennai, Tamil Nadu, India; drvenkybsms@gmail.com.""}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': ""Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, Diabetology, No. 4, Conran Smith Road, Gopalapuram, Chennai, Tamilnadu, India, 600 086; drmohans@diabetes.ind.in.""}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0484']
2882,32916132,The Impact of Prior Use of Corticosteroid to Dental Extraction on Oral Health-Related Quality of Life and Clinical Outcomes: A Randomized Clinical Trial.,"PURPOSE


To evaluate the impact of prior use of corticosteroids before dental extractions on oral health-related quality of life (OHRQoL).
METHODS


A randomized and triple-blind (patient, surgeon, and examiner) clinical trial was designed. The individuals were randomly allocated to 2 groups: test and placebo. In the test group, 2 capsules of 4 mg dexamethasone were administered orally. In the placebo group, subjects received 2 capsules with the same characteristics. In both groups, the administration took place 1 hour before the procedure. OHRQoL was assessed by the Brazilian version of Oral Health Impact Profile (OHIP-14). The OHIP-14 questionnaire and the assessment methods for clinical parameters were collected preoperatively and postoperatively. Multilevel linear regression models fitted the associations between preoperative use of corticosteroids and overall and domain-specific OHIP-14 scores over time.
RESULTS


One hundred fourteen patients were selected for study; however, 21 were excluded for not returning to postoperative control on the seventh day, resulting in 93 patients assessed (test = 44 and placebo = 49). The pain had a negative impact on OHRQoL (P < .01); however, the use of the drug had no statistically significant influence on OHRQoL (P = .62) and the clinical outcomes of pain (P = .63), mouth aperture (P = .05), and edema (P = .69).
CONCLUSIONS


The use of the 8 mg dexamethasone administered orally before the procedure was not effective on the improvement of the quality of life of patients undergoing dental extraction. However, using the medication seems to result in an improvement in the postoperative period of patients who had impacted teeth. Further research involving the analysis of OHRQoL must be performed, and other dosages and means of administration must be tested.",2020,The pain had a negative impact on OHRQoL,"['One hundred fourteen patients were selected for study; however, 21 were excluded for not returning to postoperative control on the seventh day, resulting in 93 patients assessed (test\xa0=\xa044 and placebo\xa0=\xa049', 'patients undergoing dental extraction']","['dexamethasone', 'placebo', 'OHRQoL', 'Corticosteroid to Dental Extraction']","['oral health-related quality of life (OHRQoL', 'OHRQoL', 'clinical outcomes of pain', 'Oral Health-Related Quality of Life and Clinical Outcomes', 'Brazilian version of Oral Health Impact Profile (OHIP-14', 'OHIP-14 questionnaire', 'quality of life', 'edema', 'mouth aperture']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",114.0,0.1098,The pain had a negative impact on OHRQoL,"[{'ForeName': 'Heitor B', 'Initials': 'HB', 'LastName': 'Pansard', 'Affiliation': ""Doctor of Medicine, Health and Life Sciences Master's Student by the Franciscan University (UFN), Santa Maria, RS, Brazil.""}, {'ForeName': 'Mayara C', 'Initials': 'MC', 'LastName': 'Prado', 'Affiliation': ""MD Student, Health and Life Sciences Master's Student by the Franciscan University (UFN), Santa Maria, RS, Brazil.""}, {'ForeName': 'Gabriel F', 'Initials': 'GF', 'LastName': 'Marchi', 'Affiliation': 'Private Practitioner, Specialist in Bucco Maxillofacial Surgery and Traumatology.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Sfreddo', 'Affiliation': 'Professor, Dental School Professor of the Franciscan University (UFN), Santa Maria, RS, Brazil.'}, {'ForeName': 'Jovito A', 'Initials': 'JA', 'LastName': 'Skupien', 'Affiliation': ""Department Head, Health and Life Sciences Master's and Dental School of the Franciscan University (UFN), Santa Maria, RS, Brazil. Electronic address: skupien.ja@gmail.com.""}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.013']
2883,32916135,"Composite type-2 biomarker strategy versus a symptom-risk-based algorithm to adjust corticosteroid dose in patients with severe asthma: a multicentre, single-blind, parallel group, randomised controlled trial.","BACKGROUND


Asthma treatment guidelines recommend increasing corticosteroid dose to control symptoms and reduce exacerbations. This approach is potentially flawed because symptomatic asthma can occur without corticosteroid responsive type-2 (T2)-driven eosinophilic inflammation, and inappropriately high-dose corticosteroid treatment might have little therapeutic benefit with increased risk of side-effects. We compared a biomarker strategy to adjust corticosteroid dose using a composite score of T2 biomarkers (fractional exhaled nitric oxide [FENO], blood eosinophils, and serum periostin) with a standardised symptom-risk-based algorithm (control).
METHODS


We did a single-blind, parallel group, randomised controlled trial in adults (18-80 years of age) with severe asthma (at treatment steps 4 and 5 of the Global Initiative for Asthma) and FENO of less than 45 parts per billion at 12 specialist severe asthma centres across England, Scotland, and Northern Ireland. Patients were randomly assigned (4:1) to either the biomarker strategy group or the control group by an online electronic case-report form, in blocks of ten, stratified by asthma control and use of rescue systemic steroids in the previous year. Patients were masked to study group allocation throughout the entirety of the study. Patients attended clinic every 8 weeks, with treatment adjustment following automated treatment-group-specific algorithms: those in the biomarker strategy group received a default advisory to maintain treatment and those in the control group had their treatment adjusted according to the steps indicated by the trial algorithm. The primary outcome was the proportion of patients with corticosteroid dose reduction at week 48, in the intention-to-treat (ITT) population. Secondary outcomes were inhaled corticosteroid (ICS) dose at the end of the study; cumulative dose of ICS during the study; proportion of patients on maintenance oral corticosteroids (OCS) at study end; rate of protocol-defined severe exacerbations per patient year; time to first severe exacerbation; number of hospital admissions for asthma; changes in lung function, Asthma Control Questionnaire-7 score, Asthma Quality of Life Questionnaire score, and T2 biomarkers from baseline to week 48; and whether patients declined to progress to OCS. A secondary aim of our study was to establish the proportion of patients with severe asthma in whom T2 biomarkers remained low when corticosteroid therapy was decreased to a minimum ICS dose. This study is registered with ClinicalTrials.gov, NCT02717689 and has been completed.
FINDINGS


Patients were recruited from Jan 8, 2016, to July 12, 2018. Of 549 patients assessed, 301 patients were included in the ITT population and were randomly assigned to the biomarker strategy group (n=240) or to the control group (n=61). 28·4% of patients in the biomarker strategy group were on a lower corticosteroid dose at week 48 compared with 18·5% of patients in the control group (adjusted odds ratio [aOR] 1·71 [95% CI 0·80-3·63]; p=0·17). In the per-protocol (PP) population (n=121), a significantly greater proportion of patients were on a lower corticosteroid dose at week 48 in the biomarker strategy group (30·7% of patients) compared with the control group (5·0% of patients; aOR 11·48 [95% CI 1·35-97·83]; p=0·026). Patient choice to not follow treatment advice was the principle reason for loss to PP analysis. There was no difference in secondary outcomes between study groups and no loss of asthma control among patients in the biomarker strategy group who reduced their corticosteroid dose.
INTERPRETATION


Biomarker-based corticosteroid adjustment did not result in a greater proportion of patients reducing corticosteroid dose versus control. Understanding the reasons for patients not following treatment advice in both treatment strategies is an important area for future research. The prevalence of T2 biomarker-low severe asthma was low.
FUNDING


This study was funded, in part, by the Medical Research Council UK.",2020,"There was no difference in secondary outcomes between study groups and no loss of asthma control among patients in the biomarker strategy group who reduced their corticosteroid dose.
","['patients with severe asthma', 'adults (18-80 years of age) with severe asthma (at treatment steps 4 and 5 of the Global Initiative for Asthma) and FENO of less than 45 parts per billion at 12 specialist severe asthma centres across England, Scotland, and Northern Ireland', '549 patients assessed, 301 patients were included in the ITT population and were randomly assigned to the biomarker strategy group (n=240) or to the control group (n=61', 'Patients were recruited from Jan 8, 2016, to July 12, 2018']","['Composite type-2 biomarker strategy versus a symptom-risk-based algorithm to adjust corticosteroid', 'biomarker strategy group or the control group by an online electronic case-report form, in blocks of ten, stratified by asthma control and use of rescue systemic steroids', 'automated treatment-group-specific algorithms: those in the biomarker strategy group received a default advisory to maintain treatment']","['maintenance oral corticosteroids (OCS) at study end; rate of protocol-defined severe exacerbations per patient year; time to first severe exacerbation; number of hospital admissions for asthma; changes in lung function, Asthma Control Questionnaire-7 score, Asthma Quality of Life Questionnaire score, and T2 biomarkers', 'proportion of patients with corticosteroid dose reduction', 'inhaled corticosteroid (ICS) dose at the end of the study; cumulative dose of ICS', 'composite score of T2 biomarkers (fractional exhaled nitric oxide [FENO], blood eosinophils, and serum periostin) with a standardised symptom-risk-based algorithm (control', 'loss of asthma control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0560002', 'cui_str': 'ppb'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4551412', 'cui_str': 'Electronic case report form'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0219433', 'cui_str': 'POSTN protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",301.0,0.227716,"There was no difference in secondary outcomes between study groups and no loss of asthma control among patients in the biomarker strategy group who reduced their corticosteroid dose.
","[{'ForeName': 'Liam G', 'Initials': 'LG', 'LastName': 'Heaney', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, UK. Electronic address: l.heaney@qub.ac.uk.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Busby', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, UK.""}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Hanratty', 'Affiliation': ""Centre for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen's University, Belfast, UK.""}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Djukanovic', 'Affiliation': 'School of Clinical and Experimental Sciences, University of Southampton, NIHR Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Woodcock', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester and Manchester Academic Health Science Centre and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Walker', 'Affiliation': 'Asthma UK & British Lung Foundation Partnership, London, UK.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Hardman', 'Affiliation': 'Niche Science & Technology, Falstaff House, Richmond, UK.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Arron', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Choy', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'Department of Respiratory Sciences, Institute for Lung Health and Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Brightling', 'Affiliation': 'Department of Respiratory Sciences, Institute for Lung Health and Leicester NIHR Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Rekha', 'Initials': 'R', 'LastName': 'Chaudhuri', 'Affiliation': 'NHS Greater Glasgow and Clyde Health Board, Gartnavel Hospital, and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Cowan', 'Affiliation': 'NHS Greater Glasgow and Clyde, Stobhill Hospital, Glasgow, UK.'}, {'ForeName': 'Adel H', 'Initials': 'AH', 'LastName': 'Mansur', 'Affiliation': 'University of Birmingham and Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Fowler', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester and Manchester Academic Health Science Centre and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Niven', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, University of Manchester and Manchester Academic Health Science Centre and NIHR Manchester Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Howarth', 'Affiliation': 'School of Clinical and Experimental Sciences, University of Southampton, NIHR Southampton Biomedical Research Centre, Southampton, UK.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Lordan', 'Affiliation': 'The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Menzies-Gow', 'Affiliation': 'Royal Brompton & Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Tim W', 'Initials': 'TW', 'LastName': 'Harrison', 'Affiliation': 'Nottingham Respiratory NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Robinson', 'Affiliation': 'University College Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Cecile T J', 'Initials': 'CTJ', 'LastName': 'Holweg', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Matthews', 'Affiliation': '23andMe, Sunnyvale, CA, USA.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30397-0']
2884,32916151,Synergistic effects of fructose and glucose on lipoprotein risk factors for cardiovascular disease in young adults.,"BACKGROUND


Fructose consumption increases risk factors for cardiometabolic disease. It is assumed that the effects of free sugars on risk factors are less potent because they contain less fructose. We compared the effects of consuming fructose, glucose or their combination, high fructose corn syrup (HFCS), on cardiometabolic risk factors.
METHODS


Adults (18-40 years; BMI 18-35 kg/m 2 ) participated in a parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS (25% and 17.5% ereq) were consumed for two weeks. Groups were matched for sex, baseline BMI and plasma lipid/lipoprotein concentrations. 24-h serial blood samples were collected at baseline and after the intervention. Primary outcomes were 24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose were assessed post hoc.
FINDINGS


145 subjects (26.0 ± 5.8 years; body mass index 25.0 ± 3.7 kg/m 2 ) completed the study. As expected, the increase of 24-h triglycerides compared with aspartame was highest during fructose consumption (25%: 6.66 mmol/Lx24h 95% CI [1.90 to 11.63], P = 0.0013 versus aspartame), intermediate during HFCS consumption (25%: 4.68 mmol/Lx24h 95% CI [-0.18 to 9.55], P = 0.066 versus aspartame) and lowest during glucose consumption. In contrast, the increase of LDL-C was highest during HFCS consumption (25%: 0.46 mmol/L 95% CI [0.16 to 0.77], P = 0.0002 versus aspartame) and intermediate during fructose consumption (25%: 0.33 mmol/L 95% CI [0.03 to 0.63], P = 0.023 versus aspartame), as was the increase of apoB (HFCS-25%: 0.108 g/L 95%CI [0.032 to 0.184], P = 0.001; fructose 25%: 0.072 g/L 95%CI [-0.004 to 0.148], P = 0.074 versus aspartame). The post hoc analyses showed significant interactive effects of fructose*glucose on LDL-C and apoB (both P < 0.01), but not on 24-h triglyceride (P = 0.340).
CONCLUSION


A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS. Thus, the effects of HFCS on lipoprotein risks factors are not solely mediated by the fructose content and it cannot be assumed that glucose is a benign component of HFCS. Our findings suggest that HFCS may be as harmful as isocaloric amounts of pure fructose and provide further support for the urgency to implement strategies to limit free sugar consumption.",2020,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"['young adults', 'Adults (18-40\u202fyears; BMI 18-35\u202fkg/m 2 ) participated in a']","['consuming fructose, glucose or their combination, high fructose corn syrup (HFCS', 'fructose and glucose', 'Fructose consumption', 'parallel, double-blinded dietary intervention during which beverages sweetened with aspartame, glucose (25% of energy requirements (ereq)), fructose or HFCS', 'HFCS']","['lipoprotein risk factors', '24-h triglycerides', 'LDL-C and apoB', '24-h triglyceride', '24-h serial blood samples', 'LDL-C', '24-h triglyceride AUC, LDL-cholesterol (C), and apolipoprotein (apo)B. Interactions between fructose and glucose']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C2981326', 'cui_str': 'High Fructose Corn Syrup'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}]","[{'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",145.0,0.0811716,A significant interaction between fructose and glucose contributed to increases of lipoprotein risk factors when the two monosaccharides were co-ingested as HFCS.,"[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Hieronimus', 'Affiliation': 'Max Rubner-Institut, Department of Child Nutrition, Haid-und-Neu-Strasse 9, 76131, Karlsruhe, Germany; Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America. Electronic address: bettina.hieronimus@mri.bund.de.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Medici', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Bremer', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of California, Davis, CA, United States of America; Pediatric Growth and Nutrition Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, United States of America.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Lee', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Marinelle V', 'Initials': 'MV', 'LastName': 'Nunez', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Desiree M', 'Initials': 'DM', 'LastName': 'Sigala', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, United States of America; United States Department of Agriculture, Western Human Nutrition Research Center, Davis, CA, United States of America.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Havel', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America; Department of Nutrition, University of California, Davis, CA, United States of America.'}, {'ForeName': 'Kimber L', 'Initials': 'KL', 'LastName': 'Stanhope', 'Affiliation': 'Department of Molecular Biosciences, School of Veterinary Medicine, University of California, Davis, CA, United States of America.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2020.154356']
2885,32915904,Automated vessel density detection in fluorescein angiography images correlates with vision in proliferative diabetic retinopathy.,"PURPOSE


To investigate the correlation between quantifiable vessel density, computed in an automated fashion, from ultra-widefield fluorescein angiography (UWFFA) images from patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness.
METHODS


We performed a secondary analysis of a prospective randomized controlled trial. We designed and trained an algorithm to automate retinal vessel detection from input UWFFA images. We then used our algorithm to study the correlation between baseline vessel density and best corrected visual acuity (BCVA) and CRT for patients in the RECOVERY study. Reliability of the algorithm was tested using the intraclass correlation (ICC). 42 patients from the Intravitreal Aflibercept for Retinal Non-Perfusion in Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study. These patients had PDR without significant center-involving diabetic macular edema (central retinal thickness [CRT] ≤320μm).
RESULTS


Our algorithm analyzed UWFFA images with a reliability measure (ICC) of 0.98. A positive correlation (r = 0.4071, p = 0.0075) was found between vessel density and BCVA. No correlation was found between vessel density and CRT.
CONCLUSIONS


Our algorithm is capable of reliably quantifying vessel density in an automated fashion from baseline UWFFA images. We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
TRANSLATIONAL RELEVANCE


Our work is the first to offer an algorithm capable of quantifying vessel density in an automated fashion from UWFFA images, allowing us to work toward studying the relationship between retinal vascular changes and important clinical endpoints, including visual acuity, in ischemic eye diseases.",2020,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","['proliferative diabetic retinopathy', 'Proliferative Diabetic Retinopathy (RECOVERY) trial who had both baseline UWFFA images and optical coherence tomography (OCT) data were included in our study', '42 patients from the', 'patients with proliferative diabetic retinopathy (PDR) with visual acuity and macular thickness']","['ultra-widefield fluorescein angiography (UWFFA) images', 'Intravitreal Aflibercept']","['vessel density and BCVA', 'vessel density and CRT', 'baseline vessel density and best corrected visual acuity (BCVA', 'diabetic macular edema']","[{'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0016313', 'cui_str': 'Fluorescein angiography of eye'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]",42.0,0.0724223,"We found a positive correlation between computed vessel density and BCVA in PDR patients without center-involving macular edema, but not CRT.
","[{'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bawany', 'Affiliation': 'University of Rochester School of Medicine and Dentistry, Rochester, New York, United States of America.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Rajeev S', 'Initials': 'RS', 'LastName': 'Ramchandran', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Electrical and Computer Engineering, University of Rochester, Rochester, New York, United States of America.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, United States of America.'}, {'ForeName': 'Ajay E', 'Initials': 'AE', 'LastName': 'Kuriyan', 'Affiliation': 'Department of Ophthalmology, University of Rochester Medical Center, Rochester, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0238958']
2886,32915972,Ibrutinib added to 10-day decitabine for older patients with AML and higher risk MDS.,"The treatment of older, unfit patients with acute myeloid leukemia (AML) is challenging. Based on preclinical data of Bruton tyrosine kinase expression/phosphorylation and ibrutinib cytotoxicity in AML blasts, we conducted a randomized phase 2 multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial). In total, 144 eligible patients were randomly (1:1) assigned to either 10-day decitabine combined with ibrutinib (560 mg; sequentially given, starting the day after the last dose of decitabine) (n = 72) or to 10-day decitabine (n = 72). The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms. In the decitabine plus ibrutinib arm, 41% reached complete remission/complete remission with incomplete hematologic recovery (CR/CRi), the median overall survival (OS) was 11 months, and 2-year OS was 27%; these findings compared with 50% CR/CRi, median OS of 11.5 months, and 2-year OS of 21% for the decitabine group (not significant). Extensive molecular profiling at diagnosis revealed that patients with STAG2, IDH2, and ASXL1 mutations had significantly lower CR/CRi rates, whereas patients with mutations in TP53 had significantly higher CR/CRi rates. Furthermore, multicolor flow cytometry revealed that after 3 cycles of treatment, 28 (49%) of 57 patients with available bone marrow samples had no measurable residual disease. In this limited number of cases, measurable residual disease revealed no apparent impact on event-free survival and OS. In conclusion, the addition of ibrutinib does not improve the therapeutic efficacy of decitabine. This trial was registered at the Netherlands Trial Register (NL5751 [NTR6017]) and has EudraCT number 2015-002855-85.",2020,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","['144 eligible patients', 'older, unfit patients with acute myeloid leukemia (AML', 'unfit (ie, Hematopoietic Cell Transplantation Comorbidity Index ≥3) AML patients and higher risk myelodysplasia patients (HOVON135/SAKK30/15 trial', 'older patients with AML and higher risk MDS']","['ibrutinib to 10-day decitabine', '10-day decitabine combined with ibrutinib', 'decitabine', '10-day decitabine', 'Ibrutinib added to 10-day decitabine']","['tolerability and efficacy', 'therapeutic efficacy of decitabine', '2-year OS', 'complete remission/complete remission with incomplete hematologic recovery (CR/CRi', 'number of adverse events', 'median overall survival (OS', 'CR/CRi rates']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0026985', 'cui_str': 'Myelodysplasia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",144.0,0.206533,"The addition of ibrutinib was well tolerated, and the number of adverse events was comparable for both arms.","[{'ForeName': 'Gerwin', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Chitu', 'Affiliation': 'Department of Hematology, HOVON Data Center, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital, and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Department of Hematology, Meander Hospital Amersfoort, Amersfoort, The Netherlands.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stussi', 'Affiliation': 'Department of Hematology, Ospedale Regionale, Bellinzona, Switzerland.'}, {'ForeName': 'Laimonas', 'Initials': 'L', 'LastName': 'Griskevicius', 'Affiliation': 'Hematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital Santaros Klinikos, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Peter J M', 'Initials': 'PJM', 'LastName': 'Valk', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Arjan A', 'Initials': 'AA', 'LastName': 'van de Loosdrecht', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Breems', 'Affiliation': 'Department of Hematology, ZNA Stuivenberg/Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'van Lammeren-Venema', 'Affiliation': 'Department of Hematology, Hagaziekenhuis, Den Haag, The Netherlands.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'van Zeventer', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rinske', 'Initials': 'R', 'LastName': 'Boersma', 'Affiliation': 'Department of Hematology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'Department of Hematology, Kantonsspital St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Mels', 'Initials': 'M', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Hematology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.'}, {'ForeName': 'Markus G', 'Initials': 'MG', 'LastName': 'Manz', 'Affiliation': 'Department of Medical Oncology and Hematology, Universitätsspital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Söhne', 'Affiliation': 'Department of Hematology, Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Rien', 'Initials': 'R', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Department of Hematology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Dries', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Department of Hematology, AZ Delta Roeselare, Roeselare, Belgium.'}, {'ForeName': 'Marjolein W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Department of Hematology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Marie Cecile', 'Initials': 'MC', 'LastName': 'Legdeur', 'Affiliation': 'Department of Hematology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Lidwine', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'Department of Hematology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'Division of Hematology, University Hospital Genève and Faculty of Medicine, University of Genève, Genève, Switzerland; and.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Ammatuna', 'Affiliation': 'Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Blum', 'Affiliation': 'Service and Central Laboratory of Hematology, Department of Oncology and Department of Laboratory Medicine and Pathology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Department of Hematology, Amsterdam UMC, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}]",Blood advances,['10.1182/bloodadvances.2020002846']
2887,32916347,"Neuromuscular electrical stimulation for venous thromboembolism prophylaxis and its effects on somatosensory evoked potentials: a pretrial study of a new, US Food and Drug Administration-approved device.","BACKGROUND


Neuromuscular electrical stimulation (NMES) has emerged as a viable alternative for venous thromboembolism prophylaxis. Electrical stimulation of the peroneal nerve using NMES may potentially interfere with somatosensory evoked potential (SSEP) acquisition. This feasibility study evaluates a NMES device and its effect on SSEP acquisition as an initial step in a randomized clinical trial to assess NMES for intraoperative venous thromboembolism prophylaxis.
METHODS


Healthy volunteers underwent SSEP testing during NMES in an outpatient setting. Concurrently, SSEP recordings of the posterior tibial nerve with stimulation at each ankle were obtained in 3 conditions: sham, NMES in place but inactive; ipsi, NMES active on leg ipsilateral to SSEP acquisition; and contra, NMES active on the leg contralateral to SSEP acquisition. Nonparametric statistical methods, including repeated measures, were used for data analysis.
RESULTS


Stimulation intensities on the left, right, and bilaterally did not differ (p≥0.20). Strong positive correlations were noted between the ipsilateral geko stimulus pulse width and ipsilateral SSEP stimulation intensities (left: r s =0.866, p=0.001; right: r s =0.877, p=0.001). Women required significantly higher pulse width settings than men (p=0.01). Finally, visual inspection of waveforms, as used during dynamic IONM, did not show any significant variations of P37 cortical waveforms during NMES.
CONCLUSIONS


As a preliminary step to testing NMES intraoperatively for venous thromboembolism prophylaxis, interference with SSEP acquisition was investigated in the outpatient laboratory setting. Within a small sample of healthy volunteers, no significant changes were seen in P37 cortical latencies to suggest interference between the NMES device and SSEP waveforms.",2020,"Within a small sample of healthy volunteers, no significant changes were seen in P37 cortical latencies to suggest interference between the NMES device and SSEP waveforms.","['Healthy volunteers underwent SSEP testing during NMES in an outpatient setting', 'healthy volunteers']","['Neuromuscular electrical stimulation (NMES', 'NMES', 'NMES device', 'Neuromuscular electrical stimulation']","['P37 cortical waveforms', 'P37 cortical latencies', 'ipsilateral geko stimulus pulse width and ipsilateral SSEP stimulation intensities', 'pulse width settings']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1611473', 'cui_str': 'CCNH protein, human'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.145507,"Within a small sample of healthy volunteers, no significant changes were seen in P37 cortical latencies to suggest interference between the NMES device and SSEP waveforms.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bohl', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Newell', 'Affiliation': 'Comprehensive Epilepsy Center, Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Shvarts', 'Affiliation': 'Comprehensive Epilepsy Center, Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona; Department of Neurology, University of Arizona College of Medicine, Phoenix, Arizona; Department of Neurology, Creighton University School of Medicine, Phoenix, Arizona.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Haque', 'Affiliation': 'Comprehensive Epilepsy Center, Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona; Department of Neurology, University of Arizona College of Medicine, Phoenix, Arizona; Department of Neurology, Creighton University School of Medicine, Phoenix, Arizona. Electronic address: Neuropub@barrowneuro.org.'}]",World neurosurgery,['10.1016/j.wneu.2020.09.025']
2888,32916606,"High-Sensitivity Cardiac Troponin-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women (CODE-MI): Rationale and design for a multicenter, stepped-wedge, cluster-randomized trial.","Despite evidence that high-sensitivity cardiac troponin (hs-cTn) levels in women are lower than in men, a single threshold based on the 99th percentile upper reference limit of the overall reference population is commonly used to diagnose myocardial infarction in clinical practice. This trial aims to determine whether the use of a lower female-specific hs-cTn threshold would improve the diagnosis, treatment, and outcomes of women presenting to the emergency department with symptoms suggestive of myocardial ischemia. METHODS/DESIGN: CODE-MI (hs-cTn-Optimizing the Diagnosis of Acute Myocardial Infarction/Injury in Women) is a multicenter, stepped-wedge, cluster-randomized trial of 30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital. All adults (≥20 years of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion. Over five, 5-month intervals, hospitals will be randomized to implement lower female hs-cTn thresholds according to the assay being used at each site. Men will continue to be assessed using the overall thresholds throughout. Women with a peak hs-cTn value between the female-specific and the overall thresholds will form our primary cohort. The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models. The cohort and outcomes will be obtained from routinely collected administrative data. The trial is designed to detect a 20% relative risk difference in the primary outcome, or a 2.2% absolute difference, with 82% power. CONCLUSIONS: This pragmatic trial will assess whether adopting lower female hs-cTn thresholds leads to appropriate assessment of women with symptoms suggestive of myocardial infarction, thereby improving treatment and outcomes.",2020,"The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models.","['30 secondary and tertiary care hospitals across 8 Canadian provinces, with the unit of randomization being the hospital', 'women presenting to the emergency department with symptoms suggestive of myocardial ischemia', 'women with symptoms suggestive of myocardial infarction', 'Women (CODE-MI', 'All adults (≥20\u202fyears of age) presenting to the emergency department with symptoms suggestive of myocardial ischemia and at least 1 hs-cTn test are eligible for inclusion']",[],"['CODE-MI', '1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",30.0,0.331621,"The primary outcome, a 1-year composite of all-cause mortality or readmission for nonfatal myocardial infarction, incident heart failure, or emergent/urgent coronary revascularization, will be compared before and after the implementation of female thresholds using mixed-effects logistic regression models.","[{'ForeName': 'Yinshan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Izadnegahdar', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'May K', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kavsak', 'Affiliation': 'Department of Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada; Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Scheuermeyer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""Division of Cardiovascular, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada; Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Norris', 'Affiliation': 'Faculty of Nursing and Division of Cardiovascular Surgery, University of Alberta, Edmonton, Alberta, Canada; Cardiovascular Health and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Lyon', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Pilote', 'Affiliation': 'Divisions of General Internal Medicine and Clinical Epidemiology, Department of Medicine, Research Institute of the McGill University Health Centre and McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jafna', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Ansar', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Division of Cardiovascular Surgery, New Brunswick Heart Centre, Dalhousie University, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Rychtera', 'Affiliation': 'Patient Partners, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Johnson', 'Affiliation': 'Patient Partners, Vernon, British Columbia, Canada.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science and Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Department of Emergency Medicine, Vancouver, British Columbia, Canada; St. Paul's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Humphries', 'Affiliation': 'BC Centre for Improved Cardiovascular Health (ICVHealth) at Centre for Health Evaluation and Outcome Sciences (CHEOS), Vancouver, British Columbia, Canada; Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: karin.humphries@ubc.ca.'}]",American heart journal,['10.1016/j.ahj.2020.06.013']
2889,32916607,Timing of randomization after an acute coronary syndrome in patients with type 2 diabetes mellitus.,"BACKGROUND


The timing of enrolment following an acute coronary syndrome (ACS) may influence cardiovascular (CV) outcomes and potentially treatment effect in clinical trials. Understanding the timing and type of clinical events after an ACS will allow for clinicians to better tailor evidence-based treatments to optimize therapeutic effect. Using a large contemporary trial in patients with type 2 diabetes mellitus (T2DM) post-ACS, we examined the impact of timing of enrolment on subsequent CV outcomes.
METHODS


EXAMINE was a randomized trial of alogliptin versus placebo in 5,380 patients with T2DM and a recent ACS from October 2009 to March 2013. The primary outcome was a composite of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke. The median follow-up was 18 months. In this post hoc analysis, we examined the occurrence of subsequent CV events by timing of enrollment divided by tertiles of time from ACS to randomization: 8-34, 35-56, and 57-141 days.
RESULTS


Patients randomized early (compared to the latest times) had less comorbidities at baseline including a history of heart failure (HF; 24.7% vs 33.0%), prior coronary artery bypass graft (9.6% vs 15.9%), or atrial fibrillation (5.9% vs 9.4%). Despite the reduced comorbidity burden, the risk of the primary outcome was highest in patients randomized early compared to the latest time (adjusted hazard ratio 1.47; 95% CI 1.21-1.74). Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
CONCLUSIONS


In a contemporary cohort of T2DM with a recent ACS, the risk for recurrent CV events including MI and HF hospitalization is elevated early after an ACS. Given the emergence of antihyperglycemic therapies that reduce the risk of MI and HF among patients with T2DM at high CV risk, future studies evaluating the initiation of these therapies in the early period following an ACS are warranted given the large burden of potentially modifiable CV events.",2020,"Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
","['patients with type 2 diabetes mellitus', 'patients with T2DM at high CV risk', '5,380 patients with T2DM and a recent ACS from October 2009 to March 2013', 'patients with type 2 diabetes mellitus (T2DM) post-ACS']",['alogliptin versus placebo'],"['risk of recurrent MI', 'atrial fibrillation', 'occurrence of subsequent CV events', 'prior coronary artery bypass graft', 'composite of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke', 'history of heart failure', 'HF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C1958126', 'cui_str': 'alogliptin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",5380.0,0.185278,"Similarly, patients randomized early had an increased risk of recurrent MI (adjusted hazard ratio 1.51; 95% CI 1.17-1.96) and HF hospitalization (1.49; 95% CI 1.05-2.10).
","[{'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Elharram', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada; DREAM-CV Lab, McGill University Health Centre, Montreal, Quebec, Canada. Electronic address: Abhinav.sharma@mcgill.ca.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'White', 'Affiliation': 'University of Connecticut, Farmington, CT.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Pritzker School of Medicine, Chicago, IL.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mehta', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Cambridge, MA; Cytel Corporation, Cambridge, MA, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Université de Lorraine, Inserm, Centre d'Investigations cliniques-plurithématique 1433, Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT network, Nancy, France.""}]",American heart journal,['10.1016/j.ahj.2020.07.014']
2890,32916609,Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design.,"Cardiovascular disease (CVD) is a major cause of morbidity and mortality. Although it has been widely appreciated that obesity is a major risk factor for CVD, treatments that produce effective, durable weight loss and the impact of weight reduction in reducing cardiovascular risk have been elusive. Instead, progress in CVD risk reduction has been achieved through medications indicated for controlling lipids, hyperglycemia, blood pressure, heart failure, inflammation, and/or thrombosis. Obesity has been implicated as promoting all these issues, suggesting that sustained, effective weight loss may have independent cardiovascular benefit. GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects. The GLP-1 RA semaglutide is in phase 3 studies as a medication for obesity treatment at a dose of 2.4 mg subcutaneously (s.c.) once weekly. Semaglutide Effects on Heart Disease and Stroke in Patients with Overweight or Obesity (SELECT) is a randomized, double-blind, parallel-group trial testing if semaglutide 2.4 mg subcutaneously once weekly is superior to placebo when added to standard of care for preventing major adverse cardiovascular events in patients with established CVD and overweight or obesity but without diabetes. SELECT is the first cardiovascular outcomes trial to evaluate superiority in major adverse cardiovascular events reduction for an antiobesity medication in such a population. As such, SELECT has the potential for advancing new approaches to CVD risk reduction while targeting obesity.",2020,"GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects.","['patients with established CVD and overweight or obesity but without diabetes', 'People With Overweight or Obesity (SELECT', 'Patients with Overweight or Obesity (SELECT']","['placebo', 'GLP-1 receptor agonists (RAs']","['Cardiovascular Outcomes', 'Heart Disease and Stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",,0.0928799,"GLP-1 receptor agonists (RAs) reduce weight, improve glycemia, decrease cardiovascular events in those with diabetes, and may have additional cardioprotective effects.","[{'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology and Department of Population and Data Sciences, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Deanfield', 'Affiliation': 'Farr Institute of Health Informatics Research at London, London, UK; National Institute for Cardiovascular Outcomes Research, University College London, London, United Kingdom.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Emerson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, WA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Marso', 'Affiliation': 'HCA Midwest Health Heart and Vascular Institute, Kansas City, MO.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Plutzky', 'Affiliation': ""Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Brown-Frandsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Marianne O L', 'Initials': 'MOL', 'LastName': 'Gronning', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark; Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Anders Gaarsdal', 'Initials': 'AG', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Ravn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH. Electronic address: lincofa@ccf.org.'}]",American heart journal,['10.1016/j.ahj.2020.07.008']
2891,32916655,Muscle Fatigability After Hex-Bar Deadlift Exercise Performed With Fast or Slow Tempo.,"PURPOSE


To examine the differences in muscle fatigability after resistance exercise performed with fast tempo (FT) compared with slow tempo (ST).
METHODS


A total of 8 resistance-trained males completed FT and ST hexagonal-barbell deadlifts, consisting of 8 sets of 6 repetitions at 60% 3-repetition maximum, using a randomized crossover design. Each FT repetition was performed with maximal velocity, while each repetition during ST was performed with a 3-1-3 (eccentric/isometric/concentric) tempo (measured in seconds). Isometric maximal voluntary contraction, voluntary muscle activation, and evoked potentiated twitch torque of the knee extensors were determined using twitch interpolation before, during (set 4), and after exercise. Displacement-time data were measured during the protocols.
RESULTS


The mean bar velocity and total concentric work were higher for FT compared with ST (995 [166] W vs 233 [52] W; 0.87 [0.05] m/s vs 0.19 [0.05] m/s; 4.8 [0.8] kJ vs 3.7 [1.1] kJ). Maximal voluntary contraction torque, potentiated twitch, and voluntary muscle activation were significantly reduced after FT (-7.8% [9.2%]; -5.2% [9.2%], -8.7% [12.2%]) and ST (-11.2% [8.4%], -13.3% [8.1%], -1.8% [3.6%]).
CONCLUSION


The decline in maximal voluntary force after both the FT and ST hexagonal-barbell deadlifts exercise was accompanied by a similar decline in contractile force and voluntary muscle activation.",2020,"Maximal voluntary contraction torque, potentiated twitch, and voluntary muscle activation were significantly reduced after FT (-7.8% [9.2%]; -5.2% [9.2%], -8.7% [12.2%]) and ST (-11.2% [8.4%], -13.3% [8.1%], -1.8% [3.6%]).
",[],"['resistance exercise performed with fast tempo (FT) compared with slow tempo (ST', 'Hex-Bar Deadlift Exercise Performed With Fast or Slow Tempo']","['Maximal voluntary contraction torque, potentiated twitch, and voluntary muscle activation', 'Displacement-time data', 'maximal voluntary force', 'Muscle Fatigability', 'mean bar velocity and total concentric work', 'Isometric maximal voluntary contraction, voluntary muscle activation, and evoked potentiated twitch torque of the knee extensors', 'contractile force and voluntary muscle activation']",[],"[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]",,0.0256375,"Maximal voluntary contraction torque, potentiated twitch, and voluntary muscle activation were significantly reduced after FT (-7.8% [9.2%]; -5.2% [9.2%], -8.7% [12.2%]) and ST (-11.2% [8.4%], -13.3% [8.1%], -1.8% [3.6%]).
","[{'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Collison', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Zijdewind', 'Affiliation': ''}, {'ForeName': 'Florentina J', 'Initials': 'FJ', 'LastName': 'Hettinga', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0599']
2892,32916656,"Effect of Dark Chocolate Supplementation on Tissue Oxygenation, Metabolism, and Performance in Trained Cyclists at Altitude.","Dark chocolate (DC) is high in flavonoids and has been shown to increase nitric oxide in the blood. Increased nitric oxide has the potential to improve delivery of oxygen to muscle, especially in hypoxic conditions, such as altitude. Our aim was to assess the impact of DC supplementation on cycling performance at altitude. Twelve healthy, trained cyclists (n = 2 females, n = 10 males; age = 35 [12] years; height = 177 [7] cm; mass = 75.2 [11.0] kg; VO2max = 55 [6] ml·kg-1·min-1) were randomized to supplement with 60 g of DC or placebo twice per day for 14 days in a double-blind crossover study. After the 2 weeks of supplementation, the participants attended a laboratory session in which they consumed 120 g of DC or placebo and then cycled for 90 min at 50% peak power output, followed immediately by a 10-km time trial (TT) at simulated altitude (15% O2). The plasma concentration of blood glucose and lactate were measured before and at 15, 30, 60, and 90 min during the steady-state exercise and post TT, while muscular and prefrontal cortex oxygenation was measured continuously throughout exercise using near-infrared spectroscopy. DC resulted in a higher concentration of blood glucose (5.5 [0.5] vs. 5.3 [0.9] mmol/L) throughout the trial and lower blood lactate concentration following the TT (7.7 [1.92] vs. 10.0 [4.6] mmol/L) compared with the placebo. DC had no effect on the TT performance (19.04 [2.16] vs. 19.21 ± 1.96 min) or oxygenation status in either the prefrontal cortex or muscle. The authors conclude that, although it provided some metabolic benefit, DC is not effective as an ergogenic aid during TT cycling at simulated altitude.",2020,DC resulted in a higher concentration of blood glucose (5.5 [0.5] vs. 5.3 [0.9] mmol/L) throughout the trial and lower blood lactate concentration following the TT (7.7 [1.92] vs. 10.0 [4.6] mmol/L) compared with the placebo.,"['Trained Cyclists at Altitude', 'Twelve healthy, trained cyclists (n = 2 females, n = 10 males; age = 35 [12]\xa0years; height = 177 [7]\xa0cm; mass = 75.2']","['DC supplementation', 'Dark Chocolate Supplementation', 'placebo', 'Dark chocolate (DC', 'DC or placebo']","['TT performance', 'concentration of blood glucose', 'Tissue Oxygenation, Metabolism, and Performance', 'plasma concentration of blood glucose and lactate', 'blood lactate concentration']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C3853217', 'cui_str': 'Dark chocolate'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",,0.226335,DC resulted in a higher concentration of blood glucose (5.5 [0.5] vs. 5.3 [0.9] mmol/L) throughout the trial and lower blood lactate concentration following the TT (7.7 [1.92] vs. 10.0 [4.6] mmol/L) compared with the placebo.,"[{'ForeName': 'Keely', 'Initials': 'K', 'LastName': 'Shaw', 'Affiliation': 'University of Saskatchewan.'}, {'ForeName': 'Jyotpal', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'University of Regina.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Sirant', 'Affiliation': 'University of Regina.'}, {'ForeName': 'J Patrick', 'Initials': 'JP', 'LastName': 'Neary', 'Affiliation': 'University of Regina.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'University of Saskatchewan.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0051']
2893,32788479,Accuracy of fluid delivery devices for the neonate: Are the measures assured?,"Introduction


Delivery of accurate volumes of fluid in surgical neonates and children is crucial for the good outcome of treatment. But how accurate are the calibrations on the fluid delivery devices?
Aims


This study seeks to verify the accuracy of these devices in common use in our practice.
Materials and Methods


This is a cross-sectional experimental study carried out in our center; a tertiary health facility in Southern Nigeria in May 2019. Fluid delivery devices (FDDs) used in the course of treatment of our pediatric patients were randomly included in the study. The number of drops per ml of each device was obtained by counting while the fluid dropped until a 1 ml volume was delivered. The data was then collated and analyzed.
Results


A total of 215 FDDs were included in this study. They comprised infusion giving set, Soluset (Burette) giving set, and blood giving set. The rate of delivery was 20 drops/ml (infusion giving sets), 60 drops/min (Burette/Soluset), and 15 drops/ml (Blood giving set). They were all in keeping with the labeled/assumed calibration in each of the types of FDDs P < 0.05. Therefore, the mean, median, and mode were the same.
Conclusion


This study has demonstrated that the FDDs used our center are accurately calibrated and safe as they deliver volumes of fluid as labeled. The findings in this study reassure us of the dependability and accuracy of delivery of the FDDs we use in children in our center.",2020,They were all in keeping with the labeled/assumed calibration in each of the types of FDDs P < 0.05.,"['our pediatric patients', 'neonate', 'surgical neonates and children', 'A total of 215 FDDs', 'our center; a tertiary health facility in Southern Nigeria in May 2019', 'children in our center']",['Fluid delivery devices (FDDs'],"['number of drops per ml of each device', 'rate of delivery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0426027', 'cui_str': 'Finding of speed of delivery'}]",215.0,0.0418261,They were all in keeping with the labeled/assumed calibration in each of the types of FDDs P < 0.05.,"[{'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Okoro', 'Affiliation': 'Paediatric Surgery Unit, Department of Surgery, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria.'}, {'ForeName': 'I F', 'Initials': 'IF', 'LastName': 'Gbobo', 'Affiliation': 'Paediatric Surgery Unit, Department of Surgery, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria.'}, {'ForeName': 'P W', 'Initials': 'PW', 'LastName': 'Igwe', 'Affiliation': 'Paediatric Surgery Unit, Department of Surgery, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria.'}, {'ForeName': 'D U', 'Initials': 'DU', 'LastName': 'Umeh', 'Affiliation': 'Paediatric Surgery Unit, Department of Surgery, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Okoro', 'Affiliation': 'Department of Paediatrics, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nwiwu', 'Affiliation': 'Paediatric Surgery Unit, Department of Surgery, University of Port Harcourt Teaching Hospital, Port Harcourt, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_502_19']
2894,30308558,ASSESSMENT OF ANATOMICAL AND FUNCTIONAL OUTCOMES WITH OCRIPLASMIN TREATMENT IN PATIENTS WITH VITREOMACULAR TRACTION WITH OR WITHOUT MACULAR HOLES: Results of OVIID-1 Trial.,"PURPOSE


To evaluate the anatomical and functional outcomes with ocriplasmin in patients with vitreomacular traction (VMT) with or without macular hole (MH).
METHODS


In a Phase 4, multicenter, single-arm, open-label study, eligible patients (VMT with focal adhesion, without epiretinal membrane, and with MH ≤400 µm [if present]) received a single intravitreal injection of ocriplasmin. Nonsurgical resolution of VMT (Day 28 [primary endpoint]), best-corrected visual acuity, MH closure, vitrectomy rate, and safety were assessed through Day 180.
RESULTS


Overall, 466 patients were included in the full analysis set, of whom 47.4% had VMT resolution by Day 28; resolution rates in patients with VMT without MH, VMT with MH ≤250 µm, and VMT with MH >250 to ≤400 µm were 43.4%, 68.6%, and 62.7%, respectively. Macular hole closure was higher in eyes with VMT and MH ≤250 µm (57.1%) than in eyes with VMT and MH >250 to ≤400 µm (27.5%) at Day 28. Overall, 30.8% of patients with VMT resolution gained ≥10 letters in best-corrected visual acuity at Day 180. Adverse events were consistent with the known safety profile of ocriplasmin.
CONCLUSION


Ocriplasmin is effective for resolution of VMT without or with MH (≤400 μm); treatment outcomes can be optimized with patient selection.",2019,Macular hole closure was higher in eyes with VMT and MH ≤250 µm (57.1%) than in eyes with VMT and MH >250 to ≤400 µm (27.5%) at Day 28.,"['patients with vitreomacular traction (VMT) with or without macular hole (MH', 'eligible patients (VMT with focal adhesion, without epiretinal membrane, and with MH ≤400 µm [if present]) received a']","['Ocriplasmin', 'WITH OR WITHOUT MACULAR HOLES', 'ocriplasmin', 'single intravitreal injection of ocriplasmin']","['best-corrected visual acuity, MH closure, vitrectomy rate, and safety', 'Adverse events', 'Macular hole closure', 'Nonsurgical resolution of VMT', 'VMT resolution']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0887870', 'cui_str': 'Cell-Matrix Adherens Junctions'}, {'cui': 'C0339543', 'cui_str': 'Epiretinal membrane'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0066522', 'cui_str': 'ocriplasmin'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0024441', 'cui_str': 'Macular hole'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040597', 'cui_str': 'Traction'}]",466.0,0.0748926,Macular hole closure was higher in eyes with VMT and MH ≤250 µm (57.1%) than in eyes with VMT and MH >250 to ≤400 µm (27.5%) at Day 28.,"[{'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Department of Ophthalmology, Hôpital Lariboisière (AP-HP), Université Paris 7 (Sorbonne Paris Cité), Paris, France.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zech', 'Affiliation': 'Centre Ophtalmologique Kléber, Lyon, France.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Spera', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stalmans', 'Affiliation': 'Department of Ophthalmology, University Hospitals Leuven (UZ Leuven), Leuven, Belgium.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002332']
2895,30639756,Agreement Between Breathlessness Severity and Unpleasantness in People With Chronic Breathlessness: A Longitudinal Clinical Study.,"CONTEXT


Chronic breathlessness is a cardinal symptom in cardiopulmonary disease where both overall intensity or severity (S) and unpleasantness (U) are commonly quantified.
OBJECTIVE


We aimed to evaluate agreement between breathlessness severity and unpleasantness over eight days in patients with chronic breathlessness.
METHODS


Longitudinal analysis of 265 patients with chronic breathlessness who rated current overall breathlessness severity and unpleasantness on a 0-100 mm visual analogue scale (VAS) in the morning and evening over eight days. A total of 3630 paired overall severity-unpleasantness (S-U) differences were analyzed; median 15 (IQR 13-16) per patient. Agreement was evaluated using Bland-Altman plots. Associations of the difference between severity and unpleasantness (S-U difference) with clinical factors and perceived quality of life were analyzed using multilevel linear regression adjusted for confounders.
RESULTS


Over eight days, severity and unpleasantness scores were highly correlated, had similar variability, and varied more between patients than within patients. The mean S-U difference was small at 2.1 mm. Agreement between overall severity and unpleasantness was similar or higher than expected from the variability in individual scores. The S-U difference was similar across evaluated factors including age, sex, diagnosis, morning/evening assessment, modified Medical Research Council breathlessness score, morphine treatment, and presence of different sensory qualities of breathlessness. Higher overall severity and unpleasantness associated with worse perceived quality of life in a similar way.
CONCLUSION


In patients with chronic breathlessness over eight days, overall severity and unpleasantness of breathlessness were comparable and associated to other clinical factors in a similar manner.",2019,"RESULTS


Over eight days, severity and unpleasantness scores were highly correlated, had similar variability, and varied more between patients than within patients.","['265 patients with chronic breathlessness who rated current overall breathlessness severity and unpleasantness on a 0-100\xa0mm visual analogue scale (VAS) in the morning and evening over eight days', 'patients with chronic breathlessness', 'People With Chronic Breathlessness']",[],"['overall intensity or severity (S) and unpleasantness (U', 'Breathlessness Severity and Unpleasantness', 'age, sex, diagnosis, morning/evening assessment, modified Medical Research Council breathlessness score, morphine treatment, and presence of different sensory qualities of breathlessness', 'Chronic breathlessness', 'overall severity and unpleasantness of breathlessness', 'overall severity and unpleasantness', 'mean S-U difference', 'severity and unpleasantness scores', 'severity and unpleasantness (S-U difference) with clinical factors and perceived quality of life', 'breathlessness severity and unpleasantness', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",265.0,0.0965738,"RESULTS


Over eight days, severity and unpleasantness scores were highly correlated, had similar variability, and varied more between patients than within patients.","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Lund University, Faculty of Medicine, Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Lund, Sweden; ImPaCCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia. Electronic address: pmekstrom@gmail.com.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'School of Health Sciences, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Hull York Medical School, Institute for Clinical and Applied Health Research, University of Hull, UK.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'ImPaCCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.01.001']
2896,30723231,Effects and Components of Placebos with a Psychological Treatment Rationale - Three Randomized-Controlled Studies.,"In recent years, placebos have evolved from a mean to control for 'therapeutic chaff' to something that has clinically relevant effects with biological underpinning and that is considered to have clinical as well as scientific potential. However, the wealth of scientific placebo research is conceptualized in a biomedical context, i.e. based on placebos provided with a biomedical treatment rationale, whereas little is known about effects and mechanisms of placebos provided with a psychological treatment rationale. This has important repercussions not only on placebo research, but also on attempts to establish specificity of psychological interventions, such as psychotherapy. Therefore, we set out to assess the effects and possible components of placebos provided with a psychological treatment rationale in three experiments on healthy subjects. We show that placebos provided with a psychological treatment rationale are effective in short- as well as mid-term, but only when provided by a trustworthy, friendly and empathetic experimenter. These findings indicate that placebos are effective outside the medical context and thus need be controlled for in non-medical trials. Furthermore, it highlights and confirms the importance of a plausible psychological treatment rationale in the context of a therapeutic alliance for psychological interventions, such as psychotherapy.",2019,"We show that placebos provided with a psychological treatment rationale are effective in short- as well as mid-term, but only when provided by a trustworthy, friendly and empathetic experimenter.",['healthy subjects'],"['placebos', 'Placebos']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0174248,"We show that placebos provided with a psychological treatment rationale are effective in short- as well as mid-term, but only when provided by a trustworthy, friendly and empathetic experimenter.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Gaab', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland. jens.gaab@unibas.ch.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Kossowsky', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Ehlert', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Institute of Psychology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Cosima', 'Initials': 'C', 'LastName': 'Locher', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel, Basel, Switzerland.'}]",Scientific reports,['10.1038/s41598-018-37945-1']
2897,31039280,Ketone ester supplementation blunts overreaching symptoms during endurance training overload.,"KEY POINTS


Overload training is required for sustained performance gain in athletes (functional overreaching). However, excess overload may result in a catabolic state which causes performance decrements for weeks (non-functional overreaching) up to months (overtraining). Blood ketone bodies can attenuate training- or fasting-induced catabolic events. Therefore, we investigated whether increasing blood ketone levels by oral ketone ester (KE) intake can protect against endurance training-induced overreaching. We show for the first time that KE intake following exercise markedly blunts the development of physiological symptoms indicating overreaching, and at the same time significantly enhances endurance exercise performance. We provide preliminary data to indicate that growth differentiation factor 15 (GDF15) may be a relevant hormonal marker to diagnose the development of overtraining. Collectively, our data indicate that ketone ester intake is a potent nutritional strategy to prevent the development of non-functional overreaching and to stimulate endurance exercise performance.
ABSTRACT


It is well known that elevated blood ketones attenuate net muscle protein breakdown, as well as negate catabolic events, during energy deficit. Therefore, we hypothesized that oral ketones can blunt endurance training-induced overreaching. Fit male subjects participated in two daily training sessions (3 weeks, 6 days/week) while receiving either a ketone ester (KE, n = 9) or a control drink (CON, n = 9) following each session. Sustainable training load in week 3 as well as power output in the final 30 min of a 2-h standardized endurance session were 15% higher in KE than in CON (both P < 0.05). KE inhibited the training-induced increase in nocturnal adrenaline (P < 0.01) and noradrenaline (P < 0.01) excretion, as well as blunted the decrease in resting (CON: -6 ± 2 bpm; KE: +2 ± 3 bpm, P < 0.05), submaximal (CON: -15 ± 3 bpm; KE: -7 ± 2 bpm, P < 0.05) and maximal (CON: -17 ± 2 bpm; KE: -10 ± 2 bpm, P < 0.01) heart rate. Energy balance during the training period spontaneously turned negative in CON (-2135 kJ/day), but not in KE (+198 kJ/day). The training consistently increased growth differentiation factor 15 (GDF15), but ∼2-fold more in CON than in KE (P < 0.05). In addition, delta GDF15 correlated with the training-induced drop in maximal heart rate (r = 0.60, P < 0.001) and decrease in osteocalcin (r = 0.61, P < 0.01). Other measurements such as blood ACTH, cortisol, IL-6, leptin, ghrelin and lymphocyte count, and muscle glycogen content did not differentiate KE from CON. In conclusion, KE during strenuous endurance training attenuates the development of overreaching. We also identify GDF15 as a possible marker of overtraining.",2019,KE inhibited the training-induced increase in nocturnal adrenaline (P ,['Fit male subjects'],"['ketone ester (KE, n\xa0=\xa09) or a control drink (CON', 'oral ketone ester (KE) intake', 'Ketone ester supplementation', 'KE', 'KE (P', 'noradrenaline (P']","['Energy balance', 'nocturnal adrenaline', 'maximal heart rate', 'endurance exercise performance', 'blood ketone levels', 'Blood ketone bodies', 'heart rate', 'blood ACTH, cortisol, IL-6, leptin, ghrelin and lymphocyte count, and muscle glycogen content', 'osteocalcin', 'growth differentiation factor 15 (GDF15', 'delta GDF15']","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0014898', 'cui_str': 'Ester'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C1271768', 'cui_str': 'Blood ketone level'}, {'cui': 'C1112671', 'cui_str': 'Blood ketone body'}, {'cui': 'C0860777', 'cui_str': 'Blood corticotrophin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.0244825,KE inhibited the training-induced increase in nocturnal adrenaline (P ,"[{'ForeName': 'Chiel', 'Initials': 'C', 'LastName': 'Poffé', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ramaekers', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Van Thienen', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hespel', 'Affiliation': 'Exercise Physiology Research Group, Department of Movement Sciences, KU Leuven, Leuven, Belgium.'}]",The Journal of physiology,['10.1113/JP277831']
2898,32917148,"Correction to: Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study.",An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['older patients under general anesthesia'],"['placebo', 'lidocaine/prilocaine cream']",['cardiovascular reactions from endotracheal intubation and cough events'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0617623', 'cui_str': 'Lidocaine- and prilocaine-containing product'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.0453201,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Linsheng', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'Operation Room, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Shanghai Shyndec Pharmaceutical Co., Ltd, Shanghai, 600420, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Division of Nephrology, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. naturestyle@163.com.'}, {'ForeName': 'Miaoxia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, the third Affiliated Hospital of Sun Yat-sen University, Guangzhou, 510630, Guangdong, China. 1109986151@qq.com.'}]",BMC geriatrics,['10.1186/s12877-020-01651-3']
2899,32917160,Cluster-randomised trial to test the effect of a behaviour change intervention on toilet use in rural India: results and methodological considerations.,"BACKGROUND


Effective and scalable behaviour change interventions to increase use of existing toilets in low income settings are under debate. We tested the effect of a novel intervention, the '5 Star Toilet' campaign, on toilet use among households owning a toilet in a rural setting in the Indian state of Gujarat.
METHODS


The intervention included innovative and digitally enabled campaign components delivered over 2 days, promoting the upgrading of existing toilets to achieve use by all household members. The intervention was tested in a cluster randomised trial in 94 villages (47 intervention and 47 control). The primary outcome was the proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use. We applied a separate questionnaire tool that masked open defecation questions as a physical activity study, and excluded households surveyed at baseline from the post-intervention survey. We calculated prevalence differences using linear regression with generalised estimating equations.
RESULTS


The primary study outcome was assessed in 2483 households (1275 intervention and 1208 control). Exposure to the intervention was low. Post-intervention, toilet use was 83.8% in the control and 90.0% in the intervention arm (unadjusted difference + 6.3%, 95%CI 1.1, 11.4, adjusted difference + 5.0%, 95%CI -0.1, 10.1. The physical activity questionnaire was done in 4736 individuals (2483 intervention and 2253 control), and found no evidence for an effect (toilet use 80.7% vs 82.2%, difference + 1.7%, 95%CI -3.2, 6.7). In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%). Process evaluation suggested that insufficient campaign intensity may have contributed to the low impact of the intervention.
CONCLUSION


The study highlights the challenge in achieving high intervention intensity in settings where the proportion of the total population that are potential beneficiaries is small. Responder bias may be minimised by masking open defecation questions as a physical activity study. Over-reporting of toilet use may be further reduced by avoiding repeated surveys in the same households.
TRIAL REGISTRATION


The trial was registered on the RIDIE registry ( RIDIE-STUDY-ID-5b8568ac80c30 , 27-8-2018) and retrospectively on clinicaltrials.gov ( NCT04526171 , 30-8-2020).",2020,"In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%).","['rural India', '94 villages (47 intervention and 47 control', 'households owning a toilet in a rural setting in the Indian state of Gujarat', '2483 households (1275 intervention and 1208 control', '4736 individuals (2483 intervention and 2253 control']",['behaviour change intervention'],"['toilet use measured with the main questionnaire', 'proportion of households with use of toilets by all household members, measured through self- or proxy-reported toilet use', 'physical activity questionnaire']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0562819', 'cui_str': 'Does use toilet'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",2483.0,0.105398,"In the intervention arm, toilet use measured with the main questionnaire was higher in those exposed to the campaign compared to the unexposed (+ 7.0%, 95%CI 2.2%, 11.7%), while there was no difference when measured with the physical activity questionnaire (+ 0.9%, 95%CI -3.7%, 5.5%).","[{'ForeName': 'Wolf-Peter', 'Initials': 'WP', 'LastName': 'Schmidt', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Wolf-Peter.Schmidt@lshtm.ac.uk.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Chauhan', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhavsar', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Sandul', 'Initials': 'S', 'LastName': 'Yasobant', 'Affiliation': 'Center for Development Research (ZEF), Bonn, Germany.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Patwardhan', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Aunger', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'Dileep', 'Initials': 'D', 'LastName': 'Mavalankar', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Saxena', 'Affiliation': 'Indian Institute of Public Health Gandhinagar, Opp. Airforce Head Quarters, Nr. Lekawada Bus Stop, Chiloda Road, Lekawada CRPF P.O, Gandhinagar, Gujarat, 382042, India.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Curtis', 'Affiliation': 'Environmental Health Group, Department of Disease Control, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.'}]",BMC public health,['10.1186/s12889-020-09501-y']
2900,32917187,Improving the informatics competency of critical care nurses: results of an interventional study in the southeast of Iran.,"BACKGROUND


Nursing informatics (NI) along with growth and development of health information technology (HIT) is becoming a fundamental part of all domains of nursing practice especially in critical care settings. Nurses are expected to equip with NI competency for providing patient-centered evidence-based care. Therefore, it is important and necessary to improve nurses' NI competency through educational programs for effective using of HIT. This study aimed to evaluate the impact of a training program on NI competency of critical care nurses.
METHODS


This interventional study was conducted in 2019. Stratified sampling technique was used to select 60 nurses working in critical care units of three hospitals affiliated with a large University of Medical Sciences in the southeast of Iran. These nurses were assigned randomly and equally to the control and intervention groups. NI competency was trained to the intervention group in a three-day workshop. Data were collected using demographic questionnaire and the adapted Nursing Informatics Competency Assessment Tool (NICAT) before and 1 month after the intervention. Rahman in the US (2015) developed and validated the original NICAT to assess self-reported NI competency of nurses with 30 items and three dimensions (Computer literacy, Informatics literacy Information management skills). The NICAT is scored on a five-point Likert scale and the overall score ranges from 30 to150. Two medical informatics specialists and eight nursing faculty members approved the validity of the adapted version of NICAT and its reliability was confirmed by Cronbach's alpha (95%).
RESULTS


All 60 participants completed the educational program and returned the completed questionnaire. Majority of participants in the intervention and control groups were female (83.30%), married nurses (70.90, 73.30%) aged 30-40 years (51.6, 35.5%). In the pretest stage, both intervention and control groups were competent in terms of the NI competency and its dimensions, and no significant difference was observed between them (p = 0.65). However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001). This difference showed that the intervention group was proficient in the posttest stage. The highest mean difference in the intervention group was associated with the informatics literacy dimension and the lowest mean difference was associated with the informatics management skills dimension.
CONCLUSIONS


The improved scores of NI competency and its dimensions after using the training program implied the effectiveness of this method in enhancing the NI competency of nurses working in the critical care units. The application of the training program in diverse domains of nursing practice shows its high efficiency. The project is fundamental for improving nurses' NI competency through continuous educational programs in Iran, other cultures and contexts.",2020,"However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001).","['All 60 participants completed the educational program and returned the completed questionnaire', 'Majority of participants in the intervention and control groups were female (83.30%), married nurses (70.90, 73.30%) aged 30-40\u2009years (51.6, 35.5', '60 nurses working in critical care units of three hospitals affiliated with a large University of Medical Sciences in the southeast of Iran', 'critical care nurses', 'southeast of Iran']",['training program'],['informatics literacy dimension'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0599807', 'cui_str': 'Informatics'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",,0.0237001,"However, in the posttest, the NI competency and its dimensions in the intervention group significantly increased with a large effect size compared with the control group (p = 0.001).","[{'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Jouparinejad', 'Affiliation': 'Student Research Committee, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, PO Box: 7716913555, Kerman, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Khajouei', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, PO Box: 7716913555, Kerman, Iran. j.farokhzadian@kmu.ac.ir.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01244-5']
2901,32917189,Step-by-step teaching method: improving learning outcomes of undergraduate dental students in layering techniques for direct composite resin restorations.,"BACKGROUND


Layering techniques for direct composite resin restorations might be complicated for inexperienced learners, as a number of materials and instruments are required at each step. The present study aimed to compare and assess the teaching effect of step-by-step and all-in-one teaching methods in layering techniques for direct composite resin restorations among undergraduate dental students.
METHODS


A total of 68 junior dental students participated in this study, which was a prospective and single-blind trial. The students were randomly divided into a step-by-step group (experimental group, n = 34) and all-in-one group (control group, n = 34). The same teacher taught the two groups, ensuring a comparable teaching effect. The final score of each student was an average of scores by two experts who were blinded to the grouping. The scoring system was consisted by five parts. Each part was assigned scores of 3.0, 1.5, or 0. The total maximum score was 15 and minimum was 0. The total time taken by each group was also calculated.
RESULTS


The values of the quality of tooth restorations evaluated by experts for step-by-step and all-in-one groups were 11.29 ± 2.13 from 15 and 9.00 ± 2.71 from 15 (t = 3.88, P < 0.001), respectively. In addition, the time spent by the experimental group was significantly lesser than that spent by the control group, which was 122.47 ± 2.82 and 137.18 ± 6.75 min, respectively (t = 11.72, p < 0.001).
CONCLUSION


With regard to the layering techniques for direct composite resin restorations, the outcomes were better in the step-by-step group than in the all-in-one group.",2020,"In addition, the time spent by the experimental group was significantly lesser than that spent by the control group, which was 122.47 ± 2.82 and 137.18 ± 6.75 min, respectively (t = 11.72, p < 0.001).
","['undergraduate dental students', 'undergraduate dental students in layering techniques for direct composite resin restorations', '68 junior dental students', 'direct composite resin restorations']",[],"['total maximum score', 'learning outcomes', 'values of the quality of tooth restorations', 'total time taken', 'time spent']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",68.0,0.0209915,"In addition, the time spent by the experimental group was significantly lesser than that spent by the control group, which was 122.47 ± 2.82 and 137.18 ± 6.75 min, respectively (t = 11.72, p < 0.001).
","[{'ForeName': 'Jia-Xue', 'Initials': 'JX', 'LastName': 'Yuan', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Ke-Yu', 'Initials': 'KY', 'LastName': 'Yang', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Wang', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Qing-Yu', 'Initials': 'QY', 'LastName': 'Guo', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Clinical Research Center of Shaanxi Province for Dental and Maxillofacial Diseases, College of Stomatology, Xi'an Jiaotong University, Xi'an, 710004, PR China. liufei6630@mail.xjtu.edu.cn.""}]",BMC medical education,['10.1186/s12909-020-02230-1']
2902,32917221,"The use of Lactobacillus plantarum 299v (DSM 9843) in cancer patients receiving home enteral nutrition - study protocol for a randomized, double-blind, and placebo-controlled trial.","BACKGROUND


Nutritional treatment is one of the most important components of multidisciplinary anti-cancer therapy. Home enteral nutrition is considered as a safe procedure, however, it may be associated with the risk of side effects, such as nausea, vomiting, abdominal pain, and diarrhoea. It is uncertain whether diarrhoea is the result of the enteral formula administration or gut dysbiosis. One of the methods which may be used to alter the composition of gut microbiota is the administration of a probiotic strain. Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects. Therefore, the primary aim of this study is to determine the effect of Lactobacillus plantarum 299v on prevention of weight loss of cancer patients receiving home enteral nutrition. The secondary aims are to evaluate the role of this probiotic strain in the improvement of nutritional status, enteral nutrition tolerance, and patients' quality of life.
METHODS


Forty patients with cancer receiving home enteral nutrition will be enrolled in this clinical trial and randomized to receive one capsule of Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo for 12 weeks in a double-blind manner. Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life will be measured. Measurements will be obtained at the baseline and after 4 and 12 weeks of treatment.
DISCUSSION


The adverse events observed during administration of enteral nutrition have an negative impact on enteral formula tolerance and as a consequence patients' quality of life. The previous studies have demonstrated that probiotics may reduce the gastrointestinal symptoms related to enteral nutrition. Thus, administration of Lactobacillus plantarum 299v may be effective in improvement of nutritional status, enteral nutrition tolerance, and quality of life of cancer patients receiving home enteral nutrition.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03940768 .",2020,Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects.,"['cancer patients receiving home enteral nutrition', 'cancer patients receiving home enteral nutrition - study protocol', 'Forty patients with cancer receiving home enteral nutrition']","['Lactobacillus plantarum 299v ingestion', 'Lactobacillus plantarum', 'enteral nutrition', 'Lactobacillus plantarum 299v', 'placebo', 'Lactobacillus plantarum 299v (DSM 9843', 'Lactobacillus plantarum 299v (Sanprobi IBS®) twice a day or placebo']","['weight loss', 'Laboratory tests (the level of albumin, total protein, transferrin, and total lymphocyte count), anthropometric parameters (body mass, the content of fat mass, muscle mass, and total body water), Nutritional Risk Screening (NRS 2002), enteral nutrition tolerance as well as quality of life', 'adverse events', 'nutritional status, enteral nutrition tolerance, and quality of life', 'nausea, vomiting, abdominal pain, and diarrhoea']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",40.0,0.0968996,Lactobacillus plantarum 299v ingestion was found to diminish the adverse events of irritable bowel syndrome and Clostridium difficile infection - entities that share the symptoms with enteral nutrition side effects.,"[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Kaźmierczak-Siedlecka', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland. leokadia@gumed.edu.pl.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Folwarski', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skonieczna-Żydecka', 'Affiliation': 'Department of Human Nutrition and Metabolomics, Pomeranian Medical University in Szczecin, Broniewskiego 24, 71-460, Szczecin, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Ruszkowski', 'Affiliation': 'Department of Physiopathology, Medical University of Gdansk, Dębinki 7, 80-211, Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Makarewicz', 'Affiliation': 'Department of Surgical Oncology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214, Gdansk, Poland.'}]",Nutrition journal,['10.1186/s12937-020-00598-w']
2903,32917223,Development of competency model for family physicians against the background of 'internet plus healthcare' in China: a mixed methods study.,"BACKGROUND


Identification of the service competences of family physicians is central to ensuring high-quality primary care and improving patient outcomes. However, little is known about how to assess the family physicians' service competences in primary care settings. It is necessary to develop and validate a general model of core competences of the family physician under the stage of construction of family doctor system and implementation of 'Internet Plus Healthcare' service model in China.
METHODS


The literature review, behavioural event interviews, expert consultation and questionnaire survey were performed. The scale's 35 questions were measured by response rate, highest score, lowest score, and average score for each. Delphi method was used to assess content validity, Cronbach's α to estimate reliability, and factor analysis to test structural validity. Respondents were randomly divided into two groups; data for one group were used for exploratory factor analysis (EFA) to explore possible model structure. Confirmatory factor analysis (CFA) was then performed.
RESULTS


Effective response rate was 93.56%. Cronbach's α coefficient of the scale was 0.977. Factor analysis showed KMO of 0.988. Bartlett's test showed χ 2  of 22 917.515 (df = 630), p < .001. Overall authority grade of expert consultation was 0.80, and Kendall's coefficient of concordance W was 0.194. By EFA, the five-factor model was retained after thorough consideration, and four items with factor loading less than 0.4 were proposed to obtain a five-dimension, 32-item scale. CFA was performed on the new structure, showing high goodness-of-fit test (NFI = 0.98, TLI = 0.91, SRMSR = 0.05, RMSEA = 0.04). Overall Cronbach's α coefficients of the scale and each sub-item were greater than 0.9.
CONCLUSIONS


The scale has good reliability, validity, and credibility and can therefore serve as an effective tool for assessment of Chinese family physicians' service competences.",2020,"Bartlett's test showed χ 2  of 22 917.515 (df = 630), p < .001.","[""family physicians against the background of 'internet plus healthcare' in China""]",['CFA'],"['Overall authority grade of expert consultation', 'Effective response rate']","[{'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0085801', 'cui_str': 'Factor Analysis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0234521,"Bartlett's test showed χ 2  of 22 917.515 (df = 630), p < .001.","[{'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': ""Department of Social Medicine and Health Service Management, School of Medicine and Health Management, Hangzhou Normal University, NO. 2318, Yuhangtang Rd, Yuhang District, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Xiaohe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Social Medicine and Health Service Management, School of Medicine and Health Management, Hangzhou Normal University, NO. 2318, Yuhangtang Rd, Yuhang District, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': ""Department of Social Medicine and Health Service Management, School of Medicine and Health Management, Hangzhou Normal University, NO. 2318, Yuhangtang Rd, Yuhang District, Hangzhou, Zhejiang, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Health Management, School of Medicine and Health Management, Tongji Medical College, Huazhong University of Science and Technology, No. 13 Hangkong Road, Wuhan, 430030, Hubei, People's Republic of China. lucky1230405@163.com.""}]",Human resources for health,['10.1186/s12960-020-00507-6']
2904,32917251,VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures.,"BACKGROUND


Vessel-sparing anastomotic repair (vsAR) has been developed as a less traumatic alternative to transecting anastomotic repair (tAR) to treat isolated short bulbar urethral strictures. This vessel-sparing technique could result in improved functional outcomes without jeopardizing the excellent surgical outcome after (transecting) anastomotic repair. The purpose of this study is to directly compare vsAR and tAR for both surgical and functional outcomes.
METHODS


This trial is a prospective, interventional, multi-center, single-blinded, 1:1 randomized, controlled, non-inferiority, phase II trial. Sample size calculation resulted in a required sample size of 100 patients (50 patients per arm). Trial participants will be randomized by an independent third party using a computer-based random sequence generator with permuted blocks of variable size. The primary objective of this trial is to show that vsAR is non-inferior to tAR in terms of failure-free survival after 24 months of follow-up, considering a non-inferiority limit of 10%. Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa. Secondary end-points mainly include differences in postoperative complications and changes in functional outcome parameters, which will be assessed with validated questionnaires. All participants are scheduled for follow-up at 3, 12, and 24 months postoperatively.
DISCUSSION


This trial will provide level Ib evidence about the differences in both surgical and functional outcome between vsAR and tAR, which may importantly scape the future of bulbar urethral reconstruction. Depending on the trial results, this phase II trial may generate a larger phase III trial with more statistical power and a lower alpha value.
TRIAL REGISTRATION


This trial is registered at clinicaltrials.gov ( NCT03572348 ) and in the Belgian Clinical Trial Registry (B670201837335). The trial was registered prospectively. Registered on 28 June 2018.",2020,Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa.,['isolated short bulbar urethral strictures'],"['vessel-sparing anastomotic repair and transecting anastomotic repair', 'Vessel-sparing anastomotic repair (vsAR']",['postoperative complications and changes in functional outcome parameters'],"[{'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0677554', 'cui_str': 'Anastomosis - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.258692,Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa.,"[{'ForeName': 'Wesley', 'Initials': 'W', 'LastName': 'Verla', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. wesley.verla@uzgent.be.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Waterloos', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Waterschoot', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Van Parys', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Spinoit', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Nicolaas', 'Initials': 'N', 'LastName': 'Lumen', 'Affiliation': 'Department of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04712-5']
2905,32917259,Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the ""Berlin"" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.
TRIAL DESIGN


This is a prospective, randomized (1:1 ratio), parallel group feasibility study in adult patients with proven COVID-19 associated ARDS.
PARTICIPANTS


All adult patients admitted to the ICU of Hamad Medical Corporation facilities in Qatar because of COVID-19 infection who develop moderate to severe ARDS are eligible. The inclusion criteria are above 18 years of age, proven COVID-19 infection, respiratory failure necessitating intubation and mechanical ventilation, ARDS with a P/F ratio of at least 200mmHg or less and a minimum PEEP 5cmH2O, BMI less 30 kg/ m2. The following exclusion criteria: no written consent, chronic respiratory disease, acute or chronic cardiovascular disease, pregnancy or need for special therapy (prone position and/or Extracorporeal membrane oxygenation).
INTERVENTION AND COMPARATOR


After randomisation, the group A patients will be ventilated with the test-device for 48 hours. The settings will be started with the pre-existing-PEEP. The upper pressure will be determined to achieve a tidal volume of 6 ml/kg lean body mass, while the respiratory rate will be set to maintain an arterial pH above 7.2. In group B, the ventilator settings will be adjusted by the attending ICU team in accordance with lung-protective ventilation strategy. All other treatment will be unchanged and according to our local policies/guidelines.
MAIN OUTCOMES


The primary end point is PaO2. As this is a dynamic parameter, we will record it every 6-8 hours and analyse it sequentially.
RANDOMISATION


The study team screens the ventilated patients who fulfil the inclusion criteria and randomise using a 1:1 allocation ratio after consenting using a closed envelope method. The latter were prepared and sealed in advance by an independent person.
BLINDING (MASKING)


Due to the technical nature of the study (use of a specific ventilator) blinding is only possible for the data-analysts and the patients.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The sample size calculation based on the assumption of an effect size (change in PaO2) of 1.5 SDS in the primary endpoint (PaO2), an intended power of 80%, an alpha error of 5% and an equal sample ratio results in n=7 patients needed to treat. However, to compensate for dropouts we will include 10 patients in each group, which means in total 20 patients.
TRIAL STATUS


The local registration number is MRC-05-018 with the protocol version number 3. The date of approval is 14 th  April 2020. Recruitment began 28th May 2020 and is expected to end in September 2020.
TRIAL REGISTRATION


The protocol was registered before starting subject recruitment under the title: ""Flow controlled ventilation in ARDS associated with COVID-19"" in ClinicalTrials.org with the registration number: NCT04399317 . Registered on 22 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the ""Berlin"" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.
","['ventilated patients who fulfil the inclusion criteria and randomise using a 1:1 allocation ratio after consenting using a closed envelope method', '10 patients in each group, which means in total 20 patients', 'conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS', 'The inclusion criteria are above 18 years of age, proven COVID-19 infection, respiratory failure necessitating intubation and mechanical ventilation, ARDS with a P/F ratio of at least 200mmHg or less and a minimum PEEP 5cmH2O, BMI less 30 kg/ m2', 'chronic respiratory disease, acute or chronic cardiovascular disease, pregnancy or need for special therapy (prone position and/or Extracorporeal membrane oxygenation', 'adult patients with proven COVID-19 associated ARDS', 'Acute Respiratory Distress Syndrome associated with COVID-19', 'All adult patients admitted to the ICU of Hamad Medical Corporation facilities in Qatar because of COVID-19 infection who develop moderate to severe ARDS are eligible']","['Flow controlled ventilation', 'flow-controlled ventilation']",['PaO2'],"[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}]",10.0,0.236715,"This study aims to demonstrate the positive effects on oxygenation of flow-controlled ventilation compared to conventionally ventilated patients in patients suffering from Acute respiratory distress syndrome (ARDS) associated with COVID-19.We define ARDS according to the ""Berlin"" definition integrating the oxygenation index (P/F ratio), the level of Positive End Expiratory Pressure (PEEP), radiological and clinical findings.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roehrig', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ait Hssain', 'Affiliation': 'Department of Medical Intensive Care, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Nabil Al Hamid', 'Initials': 'NAH', 'LastName': 'Shallik', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ingi Mohamed A', 'Initials': 'IMA', 'LastName': 'Elsaid', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Salma Faisal', 'Initials': 'SF', 'LastName': 'Mustafa', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Osama A M', 'Initials': 'OAM', 'LastName': 'Smain', 'Affiliation': 'Department of Medical Education, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Ashraf Abdulla', 'Initials': 'AA', 'LastName': 'Molokhia', 'Affiliation': 'Department of Medical Intensive Care, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Lance', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hamad Medical Corporation (HMC), Al-Rayyan Road, Doha, Qatar. Mlance@hamad.qa.'}]",Trials,['10.1186/s13063-020-04708-1']
2906,32917271,"High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I-II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China.","INTRODUCTION


The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant and anti-inflammatory properties such as N-acetylcysteine (NAC) can reduce the rate of exacerbations in patients with COPD. However, the beneficial effects of NAC in early-stage COPD are minimally discussed. We are investigating whether high-dose NAC has therapeutic effects in Chinese patients with early-stage COPD.
METHOD AND ANALYSIS


A randomized, double-blinded, placebo-controlled, parallel-group, multicenter clinical trial is evaluating the efficacy and safety of NAC for the long-term treatment of patients with early-stage COPD at 24 centers in China. Subjects aged 40-80 years and recruited by physicians or researchers with special training will be randomized to either NAC 600 mg twice daily group or matching placebo group for 2 years. Measurements will include forced expiratory volume in 1 s (FEV 1 ), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.
DISCUSSION


Currently, there are no randomized controlled trials with high-dose N-acetylcysteine (600 mg twice daily) for patients with mild-to-moderate COPD (GOLD I-II). We designed this multicenter randomized controlled trial (RCT) to assess the effectiveness, safety, and cost-effectiveness of long-term treatment with high-dose N-acetylcysteine. The results of this trial may guide clinical practice and change the standard of early COPD management.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR-IIR-17012604 . Registered on 07 September 2017.",2020,"Measurements will include forced expiratory volume in 1 s (FEV 1 ), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.
","['early-stage chronic obstructive pulmonary disease (GOLD I-II', 'Subjects aged 40-80\u2009years and recruited by physicians or researchers with special training', 'patients with COPD', 'patients with mild-to-moderate COPD (GOLD I-II', 'subjects with chronic obstructive pulmonary disease (COPD', 'Chinese patients with early-stage COPD', 'patients with early-stage COPD at 24 centers in China']","['high-dose N-acetylcysteine', 'High-dose N-acetylcysteine', 'placebo', 'NAC', 'acetylcysteine', 'NAC 600\u2009mg twice daily group or matching placebo']","['efficacy and safety', 'effectiveness, safety, and cost-effectiveness', 'number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis', 'rate of exacerbations']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0206335', 'cui_str': 'Pharmaceutical Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.717168,"Measurements will include forced expiratory volume in 1 s (FEV 1 ), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis.
","[{'ForeName': 'Heshen', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Longhui', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhishan', 'Initials': 'Z', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bijia', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peiyu', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shaodan', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Dongxing', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China.'}, {'ForeName': 'Pixin', 'Initials': 'P', 'LastName': 'Ran', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Xi Road, Guangzhou, Guangdong, China. pxran@gzhmu.edu.cn.'}]",Trials,['10.1186/s13063-020-04701-8']
2907,32917288,"Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL).","BACKGROUND


Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported. The objective of the present study is to assess the value of mistletoe extract as a complement to standard treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with regard to overall survival and health-related quality of life.
METHODS


The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total, 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01 to 20 mg three times per week for 9 months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status 0 to 2; main exclusion criteria are life expectancy less than 4 weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews.
DISCUSSION


To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer.
TRIAL REGISTRATION


EU Clinical Trial Register, EudraCT Number 2014-004552-64 . Registered on 19 January 2016. ClinicalTrials.gov NCT02948309 . Registered on 28 October 2016.",2020,"To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer.","['patients with advanced pancreatic cancer', 'advanced pancreatic cancer', 'pancreatic cancer patients', '290 participants', 'advanced pancreatic cancer patients with regard to overall survival and health-related quality of life', 'advanced pancreatic cancer patients']","['placebo', 'standard treatment (palliative chemotherapy or best supportive care', 'mistletoe extract', 'placebo or mistletoe extract']","['overall survival and health-related quality of life', 'overall survival and better health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C1166209', 'cui_str': 'Viscum album preparation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",290.0,0.535861,"To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer.","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Wode', 'Affiliation': 'Department Nursing, Umeå University, Umeå, Sweden. kathrin.wode@umu.se.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hök Nordberg', 'Affiliation': 'Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden.'}, {'ForeName': 'Gunver S', 'Initials': 'GS', 'LastName': 'Kienle', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Nils O', 'Initials': 'NO', 'LastName': 'Elander', 'Affiliation': 'Department Oncology and Department Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Britt-Marie', 'Initials': 'BM', 'LastName': 'Bernhardson', 'Affiliation': 'Department Learning, Informatics, Management, and Ethics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Sunde', 'Affiliation': 'Department Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sharp', 'Affiliation': 'Regional Cancer Centre Stockholm Gotland, Stockholm, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Henriksson', 'Affiliation': 'Department Radiation Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Fransson', 'Affiliation': 'Department Nursing, Umeå University, Umeå, Sweden.'}]",Trials,['10.1186/s13063-020-04581-y']
2908,32917417,"Effects of brown seaweeds on postprandial glucose, insulin and appetite in humans - A randomized, 3-way, blinded, cross-over meal study.","BACKGROUND & AIMS


Seaweed including brown seaweeds with rich bioactive components may be efficacious for a glycaemic management strategy and appetite control. We investigated the effects of two brown edible seaweeds, Laminaria digitata (LD) and Undaria pinnatifida (UP), on postprandial glucose metabolism and appetite following a starch load in a human meal study.
METHODS


Twenty healthy subjects were enrolled in a randomized, 3-way, blinded cross-over trial. The study was registered under ClinicalTrials.gov Identifier no. NCT00123456. At each test day, the subjects received one of three meals comprising 30 g of starch with 5 g of LD or UP or an energy-adjusted control meal containing pea protein. Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) concentrations were measured. Subjective appetite sensations were scored using visual analogue scales (VAS).
RESULTS


Linear mixed model (LMM) analysis showed a lower blood glucose, insulin and C-peptide response following the intake of LD and UP, after correction for body weight. Participants weighing ≤ 63 kg had a reduced glucose response compared to control meal between 40 and 90 min both following LD and UP meals. Furthermore, LMM analysis for C-peptide showed a significantly lower response after intake of LD. Compared to the control meal, GLP-1 response was higher after the LD meal, both before and after the body weight adjustment. The VAS scores showed a decreased appetite sensation after intake of the seaweeds. Ad-libitum food intake was not different three hours after the seaweed meals compared to control.
CONCLUSIONS


Concomitant ingestion of brown seaweeds may help improving postprandial glycaemic and appetite control in healthy and normal weight adults, depending on the dose per body weight.
CLINICAL TRIAL REGISTRY NUMBER


Clinicaltrials.gov (ID# NCT02608372).",2020,"Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1","['healthy and normal weight adults', 'Twenty healthy subjects']",['starch with 5\xa0g of LD or UP or an energy-adjusted control meal containing pea protein'],"['Laminaria digitata (LD) and Undaria pinnatifida (UP), on postprandial glucose metabolism and appetite', 'VAS scores', 'glucose response', 'appetite sensation', 'visual analogue scales (VAS', 'postprandial glycaemic and appetite control', 'GLP-1) concentrations', 'Subjective appetite sensations', 'GLP-1 response', 'postprandial glucose, insulin and appetite', 'Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1', 'blood glucose, insulin and C-peptide response']","[{'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0751493', 'cui_str': 'Kelp'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3535674', 'cui_str': 'Pea Proteins'}]","[{'cui': 'C0751493', 'cui_str': 'Kelp'}, {'cui': 'C1030485', 'cui_str': 'Undaria pinnatifida'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003622', 'cui_str': 'Appetite control'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",20.0,0.129334,"Fasting and postprandial blood glucose, insulin, C-peptide and glucagon-like peptide-1","[{'ForeName': 'Nazikussabah', 'Initials': 'N', 'LastName': 'Zaharudin', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Faculty of Industrial Sciences and Technology, Universiti Malaysia Pahang, Gambang, Pahang, Malaysia.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Tullin', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ceyda Tugba', 'Initials': 'CT', 'LastName': 'Pekmez', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: ctp@nexs.ku.dk.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Sloth', 'Affiliation': 'Research Group for NanoBio Science, National Food Institute, Technical University of Denmark, Kgs Lyngby, Denmark.'}, {'ForeName': 'Rie R', 'Initials': 'RR', 'LastName': 'Rasmussen', 'Affiliation': 'Research Group for NanoBio Science, National Food Institute, Technical University of Denmark, Kgs Lyngby, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.08.027']
2909,32917424,Adolescents as Agents of Parental Healthy Lifestyle Behavior Change: COPE Healthy Lifestyles TEEN Program.,"INTRODUCTION


Obesity is a leading health crisis around the world. An intervention strategy scarcely utilized for behavior change is that of a child as change agent. The purpose of this study was to describe the impact of teens reviewing newsletters from a healthy lifestyle intervention with their parents.
METHOD


Evaluation data from a randomized controlled trial, COPE Healthy Lifestyle TEEN Program, was analyzed. A descriptive study was conducted of parents' and teens' lifestyle behaviors as reported by parents.
RESULTS


One hundred sixty-nine parents completed evaluations. Two thirds of parents reported changing a behavior as a result of the program. Nearly three quarters of parents reported behavior changes in their teens. Over 90% reported they would recommend this or a similar program.
DISCUSSION


The obesity epidemic shows no signs of reversal, and hence multiple approaches to impact healthy lifestyles are urgent. Including children as a change agent is a potential target for interventions addressing obesity.",2020,Nearly three quarters of parents reported behavior changes in their teens.,"['Adolescents as Agents of Parental Healthy Lifestyle Behavior Change: COPE Healthy Lifestyles TEEN Program', ""parents' and teens' lifestyle behaviors as reported by parents"", 'One hundred sixty-nine parents completed evaluations', 'teens reviewing newsletters from a healthy lifestyle intervention with their parents']",[],['behavior changes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0027988', 'cui_str': 'Newsletters'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",169.0,0.0232846,Nearly three quarters of parents reported behavior changes in their teens.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Bernadette Mazurek', 'Initials': 'BM', 'LastName': 'Melnyk', 'Affiliation': ''}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Hoying', 'Affiliation': ''}]",Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners,['10.1016/j.pedhc.2020.06.012']
2910,32917440,Ultrasound Guidance Versus Landmark-Guided Palpation for Radial Arterial Line Placement by Novice Emergency Medicine Interns: A Randomized Controlled Trial.,"BACKGROUND


More than 10 million arterial lines are placed annually worldwide, many of which happen in the emergency department. Before the introduction of point-of-care ultrasound, landmark-guided palpation (LMGP) was considered standard of care.
OBJECTIVE


The objective of this study is to compare ultrasound-guided (USG) and LMGP of radial arterial line cannulation by novice emergency medicine interns.
METHODS


This was a single-center, prospective, randomized controlled trial (NCT03326739) of a convenience sample of adult patients who presented to an urban, university hospital with 100,000 visits annually. There was no funding for this study. Patients who required an arterial line were blindly randomized into LMGP or USG groups. Only novice emergency medicine interns, defined as interns with <15 previous placements, who were not blinded, performed the cannulation. Statistical analyses included t and Fisher exact tests.
RESULTS


Forty patients were enrolled with 20 patients randomized to each group. USG had a first-pass success of 75% vs. 0% for LMGP (p < 0.00001) and an overall success of 100% vs. 15% for LMGP (p < 0.00001), a mean of 1.30 attempts vs. 2.95 attempts for LMGP (a difference of 1.65; p < 0.0001), and a mean time for placement of 264 s vs. 524 s for LMGP (a difference of 260; p = 0.0025). Of the failed LMGP, USG crossover was 100% successful with a mean of 1.37 attempts (95% confidence interval 0.58-2.16) and 180 s for placement (95% confidence interval 97.92-262.08). Five percent of LMGP had a complication vs. 0% for USG (p = 1.0).
CONCLUSIONS


USG improved first-pass and overall success of radial arterial line cannulation while reducing time to access and attempts when used by novice emergency medicine interns.",2020,"CONCLUSIONS


USG improved first-pass and overall success of radial arterial line cannulation while reducing time to access and attempts when used by novice emergency medicine interns.","['Forty patients were enrolled with 20 patients randomized to each group', 'Interns', 'Patients who required an arterial line', 'adult patients who presented to an urban, university hospital with 100,000 visits annually']","['ultrasound-guided (USG) and LMGP of radial arterial line cannulation', 'LMGP or USG', 'Ultrasound Guidance Versus Landmark-Guided Palpation for Radial Arterial Line Placement by Novice Emergency Medicine', 'LMGP']",['overall success'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003835', 'cui_str': 'Arterial line'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0003835', 'cui_str': 'Arterial line'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013964', 'cui_str': 'Emergency medicine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",40.0,0.349153,"CONCLUSIONS


USG improved first-pass and overall success of radial arterial line cannulation while reducing time to access and attempts when used by novice emergency medicine interns.","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Gibbons', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Zanaboni', 'Affiliation': 'Department of Emergency Medicine, Einstein Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Schae M', 'Initials': 'SM', 'LastName': 'Saravitz', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Costantino', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.07.029']
2911,32917473,"Effect of extracorporeal shock wave therapy for burn scar regeneration: A prospective, randomized, double-blinded study.","PURPOSE


This study aimed to investigate the regeneration effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar regeneration using objective measurements.
METHODS


This was a double-blinded, randomized, controlled trial of 48 participants who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis. The ESWT group (n=25) received shock waves with low-energy flux density (0.05-0.30mJ/mm 2 ). The interval between treatments is a 1-week. The ESWT group also received recommended treatment. The control group (n=23) only received standard treatment. We measured skin characteristics before treatment and after 6 weeks for both groups.
RESULTS


No significant intergroup difference was noted at the initial evaluations (p>0.05). The pre- to post-treatment change in the scar thickness (p=0.03) and erythema (p=0.03), greater reduction was found in the ESWT group than control group. The pre- to post-treatment change in the sebum level (p=0.02), more increase was found in the ESWT group. We found no significant differences in the change measurements between the two groups for melanin levels (p=0.62) and transepidermal water loss (TEWL) (p=0.94). The changes (skin distensibility, biological skin elasticity, gross skin elasticity, and skin viscoelasticity) measured with the Cutometer showed no significant differences between the two groups (p=0.87, p=0.32, p=0.37, and p=0.29, respectively).
CONCLUSION


This is the first report of ESWT on hypertrophic scar after burn using objective tools (melanin, erythema, sebum, TEWL, elasticity and thickness). ESWT has objective beneficial effects on burn-associated scar characteristics.",2020,We found no significant differences in the change measurements between the two groups for melanin levels (p=0.62) and transepidermal water loss (TEWL) (p=0.94).,"['burn scar regeneration', '48 participants who had undergone autologous split-thickness skin grafting (STSG) with same artificial dermis']","['extracorporeal shock wave therapy (ESWT', 'standard treatment', 'extracorporeal shock wave therapy', 'ESWT']","['sebum level', 'transepidermal water loss (TEWL', 'changes (skin distensibility, biological skin elasticity, gross skin elasticity, and skin viscoelasticity', 'scar thickness', 'melanin levels', 'hypertrophic scar', 'hypertrophic scar regeneration', 'skin characteristics']","[{'cui': 'C0036280', 'cui_str': 'Burn scar'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0423756', 'cui_str': 'Thickness of skin'}, {'cui': 'C0439061', 'cui_str': 'Split thickness skin graft (procedure)'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011646', 'cui_str': 'Dermis structure'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}]",48.0,0.0744747,We found no significant differences in the change measurements between the two groups for melanin levels (p=0.62) and transepidermal water loss (TEWL) (p=0.94).,"[{'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Joo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Cho', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Gi Yeun', 'Initials': 'GY', 'LastName': 'Hur', 'Affiliation': 'Department of plastic and Reconstructive Surgery, Hangang Sacred Heart Hospital, Hallym University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Cheong Hoon', 'Initials': 'CH', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Hangang Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea. Electronic address: pmrseo@hallym.ac.kr.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.08.009']
2912,32917672,An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial.,"OBJECTIVES


Coach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes' willingness to dope as the primary outcome.
METHODS


We delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.
RESULTS


Compared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).
CONCLUSIONS


Antidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.
TRIAL REGISTRATION NUMBER


This trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).",2020,Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations.,['Participants were 130 coaches and 919 athletes'],['optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE'],"['efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours', 'antidoping knowledge', 'willingness to take prohibited substances (effect size g=0.17) and psychological need frustration', 'doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0016770', 'cui_str': 'Feeling frustrated'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.157207,Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations.,"[{'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'School of Psychology, Curtin University, Perth, Western Australia, Australia nikos.ntoumanis@curtin.edu.au.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Patterson', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Kaffe', 'Affiliation': 'Department of Physical Education and Sport Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Backhouse', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, West Yorkshire, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': 'Department of Social and Welfare Studies, Linköping University, Linkoping, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Whitaker', 'Affiliation': 'UK Coaching, Leeds, UK.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Barkoukis', 'Affiliation': 'Department of Physical Education and Sport Sciences, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Brendan J', 'Initials': 'BJ', 'LastName': 'Smith', 'Affiliation': 'School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Staff', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gucciardi', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101963']
2913,32090996,Integrating Augmented Reality Tools in Breast Cancer Related Lymphedema Prognostication and Diagnosis.,"Breast cancer related lymphedema (BCRL) is a detrimental condition characterized by fluid accumulation in the upper limb in breast cancer patients subjected to axillary surgery and/or radiations. Its etiology is multifactorial and include also tumor-specific pathological features, such as lymphovascular invasion (LVI) and extranodal extension (ENE). To date, no widely employed guidelines for the early diagnosis of BCRL are available. Here, we illustrate a protocol for a digitally assisted BCRL assessment using a 3D laser scanner (3DLS) and a tablet computer. It has been specifically optimized in a discovery cohort of high-risk breast cancer patients. This study provides a proof-of-principle that augmented reality tools, such as 3DLS, can be incorporated into the clinical workup of BCRL to allow for a precise, reproducible, reliable, and cheap diagnosis.",2020,"This study provides a proof-of-principle that augmented reality tools, such as 3DLS, can be incorporated into the clinical workup of BCRL to allow for a precise, reproducible, reliable, and cheap diagnosis.","['breast cancer patients subjected to axillary surgery and/or radiations', 'Breast cancer related lymphedema (BCRL', 'high-risk breast cancer patients']",['3D laser scanner (3DLS'],[],"[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]",[],,0.0210843,"This study provides a proof-of-principle that augmented reality tools, such as 3DLS, can be incorporated into the clinical workup of BCRL to allow for a precise, reproducible, reliable, and cheap diagnosis.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Invernizzi', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"".'}, {'ForeName': 'Letterio', 'Initials': 'L', 'LastName': 'Runza', 'Affiliation': ""Division of Pathology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Sire', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"".'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lippi', 'Affiliation': 'Physical and Rehabilitative Medicine, Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"".'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Blundo', 'Affiliation': ""Division of Breast Surgery, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.""}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Gambini', 'Affiliation': ""Division of Medical Oncology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.""}, {'ForeName': 'Renzo', 'Initials': 'R', 'LastName': 'Boldorini', 'Affiliation': 'Division of Pathology, Maggiore della Carità Hospital; Department of Health Sciences, University of Eastern Piedmont ""A. Avogadro"".'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': ""Division of Pathology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Department of Biomedical, Surgical, and Dental Sciences, University of Milan.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fusco', 'Affiliation': ""Division of Pathology, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Department of Biomedical, Surgical, and Dental Sciences, University of Milan; nicola.fusco@unimi.it.""}]",Journal of visualized experiments : JoVE,['10.3791/60093']
2914,32919056,Exercise-induced changes in brain activity during memory encoding and retrieval after long-term bed rest.,"Episodic memory depends decisively on the hippocampus and the parahippocampal gyrus, brain structures that are also prone to exercise-induced neuroplasticity and cognitive improvement. We conducted a randomized controlled trial to investigate the effects of a high-intensity exercise program in twenty-two sedentary men resting in bed for 60 days on episodic memory and its neuronal basis. All participants were exposed to 60 days of uninterrupted bed rest. Eleven participants were additionally assigned to a high-intensity interval training that was performed five to six times weekly for 60 days. Episodic memory and its neural basis were determined four days prior to and on the 58th day of bed rest using functional magnetic resonance imaging (fMRI). We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly. These findings indicate a higher neuronal efficiency in the training group during memory encoding and retrieval and may suggest a dysfunctional mechanism in the non-exercising bed rest group induced by two months of physical inactivity. Our results provide further support for the modulating effects of physical exercise and adverse implications of a sedentary lifestyle and bedridden patients.",2020,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"['Eleven participants', 'twenty-two sedentary men resting in bed for 60 days on episodic memory and its neuronal basis']",['high-intensity exercise program'],"['BOLD signal', 'neuronal efficiency', 'brain activity']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",22.0,0.0382575,We found increased BOLD signal in the left hippocampus and parahippocampal gyrus in the non-exercising group compared to the exercising bed rest group whereas the mnemonic performance did not differ significantly.,"[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Werner', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Université de Normandie, INSERM U 1075 COMETE, 14000 Caen, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Brauns', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Hanns-Christian', 'Initials': 'HC', 'LastName': 'Gunga', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany; Max-Planck-Institute for Human Development, Lise Meitner Group for Environmental Neuroscience, 14195 Berlin, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Stahn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, a corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Physiology, Charitéplatz 1, CharitéCrossOver, Virchowweg 6, 10117 Berlin, Germany; Unit of Experimental Psychiatry, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: astahn@pennmedicine.upenn.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117359']
2915,32919068,Effect of high-dose mineralocorticoid receptor antagonist eplerenone on urinary albumin excretion in patients with type 2 diabetes and high cardiovascular risk: Data from the MIRAD trial.,"AIM


As mineralocorticoid receptor antagonists (MRAs) may possess renoprotective effects in type 2 diabetes (T2D), it was decided to investigate the impact of high-dose MRA on prespecified secondary endpoints-namely, change in urinary albumin-creatinine ratio (UACR) and 24-h ambulatory blood pressure-in the MIRAD trial.
METHODS


This was a double-blind clinical trial in which T2D patients at high risk of or with established cardiovascular disease (CVD) were randomized to either high-dose (100-200 mg) eplerenone or a dose-matched placebo as an add-on to background antihypertensive treatment for 26 weeks. Safety was evaluated by the incidence of hyperkalaemia and kidney-related adverse events.
RESULTS


A total of 140 patients were enrolled (70 in each group). Baseline UACR was 17 mg/g (geometric mean; 95% CI: 13 to 22); this decreased by 34% in the eplerenone group compared with the placebo group at week 26 (95% CI: -51% to -12%; P =  0.005). There was no significant decrease in 24-h systolic blood pressure (SBP) due to treatment (-3 mmHg; 95% CI: -6 to 1; P =  0.150). However, the observed change in 24-h SBP correlated with the relative change in UACR in the eplerenone group (r = 0.568, P <  0.001). Mean baseline (± SD) estimated glomerular filtration rate (eGFR) was 85 (± 18.6) mL/min/1.73 m 2 , and 12 (± 9%) had an eGFR of 41-59 mL/min/1.73 m 2 . No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P =  0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed.
CONCLUSION


The addition of high-dose eplerenone to T2D patients at high risk of CVD can markedly reduce UACR with an acceptable safety profile.",2020,"No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P =  0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed.
","['T2D patients at high risk of or with established cardiovascular disease (CVD', 'type 2 diabetes (T2D', 'patients with type 2 diabetes and high cardiovascular risk', '140 patients were enrolled (70 in each group']","['eplerenone or a dose-matched placebo', 'high-dose mineralocorticoid receptor antagonist eplerenone', 'placebo', 'mineralocorticoid receptor antagonists (MRAs']","['24-h SBP', '24-h systolic blood pressure (SBP', 'UACR', 'Mean baseline (± SD) estimated glomerular filtration rate (eGFR', 'incidence of mild hyperkalaemia', 'urinary albumin-creatinine ratio (UACR) and 24-h ambulatory blood pressure', 'urinary albumin excretion', 'Baseline UACR', 'severe hyperkalaemia', 'incidence of hyperkalaemia and kidney-related adverse events']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0486293', 'cui_str': 'Albumin/creatinine ratio measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",140.0,0.57451,"No significant differences in the incidence of mild hyperkalaemia (≥ 5.5 mmol/L; eplerenone vs placebo: 6 vs 2, respectively; P =  0.276) and no severe hyperkalaemia (≥ 6.0 mmol/L) were observed.
","[{'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Brandt-Jacobsen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Marie Louise', 'Initials': 'ML', 'LastName': 'Johansen', 'Affiliation': 'Department of Endocrinology-Internal Medicine, Copenhagen University Hospital, Herlev-Gentofte Hospital.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark; Department of Internal Medicine, Holbæk Hospital, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen; Section of Biostatistics, Department of Public Health, University of Copenhagen.'}, {'ForeName': 'Maria Refsgaard', 'Initials': 'MR', 'LastName': 'Holm', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Endocrinology-Internal Medicine, Copenhagen University Hospital, Herlev-Gentofte Hospital; Faculty of Health and Medical Sciences, University of Copenhagen.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'Université de Lorraine, INSERM CIC Plurithémathique 1433, UMRS 1116 INSERM, CHRU Nancy, and FCRIN INI-CRCT, Nancy, France.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen; Department of Cardiology, Copenhagen University Hospital, Herlev-Gentofte Hospital.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen. Electronic address: cnkistorp@dadlnet.dk.'}]",Diabetes & metabolism,['10.1016/j.diabet.2020.08.005']
2916,32919076,"Antibiotics versus no therapy in kidney transplant recipients with asymptomatic bacteriuria (BiRT): a pragmatic, multicentre, randomised controlled trial.","OBJECTIVES


Many transplant physicians screen for and treat asymptomatic bacteriuria (ASB) during post-kidney transplant surveillance. We investigated whether antibiotics are effective in reducing the occurrence of symptomatic urinary tract infection (UTI) in kidney transplant recipients with ASB.
METHODS


We performed this multicentre, randomised, open-label trial in kidney transplant recipients who had ASB and were ≥2 months post-transplantation. We randomly assigned participants to receive antibiotics or no therapy. The primary outcome was the incidence of symptomatic UTI over the subsequent 12 months.
RESULTS


199 kidney transplant recipients with ASB were randomly assigned to antibiotics (100 participants) or no therapy (99 participants). There was no significant difference in the occurrence of symptomatic UTI between the antibiotic and no-therapy groups (27% [27/100] versus 31% [31/99], univariate Cox model: hazard ratio 0.83 [95% CI: 0.50-1.40], log-rank test: p=0.49). Over the one-year study period, antibiotic use was five times higher in the antibiotic group than in the no-therapy group (30 antibiotic days/participant [interquartile range, 20-41] versus 6 [interquartile range, 0-15], p<0.001). Overall, 155/199 participants (78%) had at least one further episode of bacteriuria during the follow-up. Compared with the participant's baseline episode of ASB, the second episode of bacteriuria was more frequently caused by a bacteria resistant to clinically relevant antibiotics (ciprofloxacin, cotrimoxazole, 3 rd -generation cephalosporin) in the antibiotic group than in the no-therapy group (18% [13/72] versus 4% [3/83], p=0.003).
CONCLUSIONS


Applying a screen-and-treat strategy for ASB does not reduce the occurrence of symptomatic UTI in kidney transplant recipients who are more than two months post-transplantation. Furthermore, this strategy increases antibiotic use and promotes the emergence of resistant organisms.",2020,"We investigated whether antibiotics are effective in reducing the occurrence of symptomatic urinary tract infection (UTI) in kidney transplant recipients with ASB.
","['kidney transplant recipients with ASB', 'kidney transplant recipients who are more than two months post-transplantation', 'kidney transplant recipients who had ASB and were ≥2\xa0months post-transplantation', 'kidney transplant recipients with asymptomatic bacteriuria (BiRT', '199 kidney transplant recipients with ASB']","['antibiotics or no therapy', 'Antibiotics versus no therapy', 'antibiotics']","['incidence of symptomatic UTI', 'episode of bacteriuria', 'occurrence of symptomatic UTI']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0262380', 'cui_str': 'Asymptomatic bacteriuria'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004659', 'cui_str': 'Bacteriuria'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",199.0,0.123239,"We investigated whether antibiotics are effective in reducing the occurrence of symptomatic urinary tract infection (UTI) in kidney transplant recipients with ASB.
","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Coussement', 'Affiliation': 'Division of Infectious Diseases, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium; Department of Nephrology, Dialysis and Renal Transplantation, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: juliencoussement@gmail.com.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Organ Transplantation, Hôpital Rangueil, Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, INSERM U10403, Toulouse, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Matignon', 'Affiliation': ""Centre d'Investigation Clinique Biothérapie, Hôpital H. Mondor-A. Chenevier, APHP (Assistance Publique-Hôpitaux de Paris), Créteil, France; Université Paris-Est, UMR_S955, UPEC, Créteil, France; INSERM U955, Equipe 21, Créteil, France; Nephrology and Transplantation Department, Hôpital H. Mondor-A. Chenevier, APHP (Assistance Publique-Hôpitaux de Paris), Créteil, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Weekers', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Liège, Liège, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Scemla', 'Affiliation': 'Department of Nephrology - Transplantation, Hôpital Necker Enfants Malades, APHP (Assistance Publique-Hôpitaux de Paris), Université Paris Descartes Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Giral', 'Affiliation': 'Institute for Transplantation, Urology and Nephrology (ITUN), Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Racapé', 'Affiliation': 'Research Center ""Biostatistiques, Epidémiologie et Recherche Clinique"", École de Santé Publique, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Alamartine', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Saint-Étienne, Saint-Étienne, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mesnard', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Hôpital Tenon, APHP (Assistance Publique-Hôpitaux de Paris), Sorbonne Université, Paris, France.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Kianda', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Ghisdal', 'Affiliation': 'Department of Nephrology, Centre Hospitalier EpiCURA, Baudour, Belgium.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Catalano', 'Affiliation': 'Department of Nephrology, Dialysis and Renal Transplantation, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Emine N', 'Initials': 'EN', 'LastName': 'Broeders', 'Affiliation': 'Department of Nephrology, Dialysis and Renal Transplantation, CUB-Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Denis', 'Affiliation': 'Laboratory of Microbiology, CHU UCL Namur, Université Catholique de Louvain, Yvoir, Belgium.'}, {'ForeName': 'Karl M', 'Initials': 'KM', 'LastName': 'Wissing', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hazzan', 'Affiliation': 'Nephrology Department, University Hospital of Lille, INSERM U995, Lille, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Abramowicz', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Antwerpen, Universiteit Antwerpen, Antwerp, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.09.005']
2917,32919092,"Training effects of attention and EF strategy-based training ""Nexxo"" in school-age students.","Given the importance of attention and executive functions in children's behavior, programs directed to improve these processes are of interest. Nexxo-training combines the use of the Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies. The present paper reports a test of Nexxo's impact on children aged 6-7 and 8-9 years. We conducted a randomized active-controlled trial involving 108 typically-developing children: 1st grade (N = 61, M = 6.46 years, SD = 0.35) and 3rd grade (N = 47, M = 8.5 years, SD = 0.27), randomly assigned to: (1) experimental, (2) active-control, or (3) passive-control groups. A 2-month follow-up was carried out after the intervention. The 3rd grade experimental group displayed a significant reduction in attentional problems at follow-up compared to both control groups. Executive Function problems were also reduced at follow-up in the experimental group. Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls. Although group effect was not significant at t1, it was significant at post measures in experimental group compared to passive-controls. Nexxo-training revealed a trend-level improvement in attention and executive functions for children in the 3rd grade.",2020,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"['school-age students', '108 typically-developing children: 1st grade (N\xa0=\xa061, M\xa0=\xa06.46\xa0years, SD\xa0=\xa00.35) and 3rd grade (N\xa0=\xa047, M\xa0=\xa08.5\xa0years, SD\xa0=\xa00.27', 'children aged 6-7 and 8-9\xa0years']","['attention and EF strategy-based training ""Nexxo', 'active-control, or (3) passive-control groups', 'Nexxo-training', 'Nexxo touchscreen application (go/no-go and stop signal tasks) with procedural metacognitive strategies']","['attention and executive functions', 'Executive Function problems', 'attentional problems']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C4517877', 'cui_str': '8.5'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",108.0,0.0178247,Participants in this group improved in Supervision (self-monitoring) at post-intervention and follow-up compared to passive-controls.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rossignoli-Palomeque', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain. Electronic address: teresa.rossignoli@ucm.es.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Perez-Hernandez', 'Affiliation': 'Department of Development and Educational Psychology, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'González-Marqués', 'Affiliation': 'Department of Basic Psychology II, Complutense University of Madrid, Madrid, Spain.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103174']
2918,32917359,"Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium) versus nebulized short-acting dual bronchodilator (salbutamol/ipratropium) in chronic obstructive pulmonary disease: A double-blind, randomized, placebo-controlled trial.","INTRODUCTION


Most guidelines recommend long-acting bronchodilators over short-acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD). The available evidence for the guidelines was based on dry powder or pressurized metered dose inhalers, but not nebulizations. Nevertheless, there is considerable, poorly evidenced based, use of short acting nebulized bronchodilators.
METHODS


This was an investigator initiated, randomized, active controlled, cross-over, double-blind and double-dummy single centre study in patients with stable COPD. The active comparators were indacaterol/glycopyrronium 110/50 μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5 mg via air driven nebulization (SAL/IPR), both given as a single dose on separate days. The primary end point was the area under the FEV 1  curve from baseline till 6 h. Secondary end points included change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity.
RESULTS


A total of 33 COPD patients completed the trial and were evaluable, most of them were ex-smokers. The difference between the tested regimens for the primary endpoint, FEV 1  AUC 0-6 h, 2965 ± 1544 mL (mean ± SD) for IND/GLY versus 3513 ± 1762 mL for SAL/IPR, was not significant (P = 0.08). The peak in FEV1 was higher and was reached faster with SAL/IPR compared to IND/GLY. No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
CONCLUSION


Among patients with stable COPD, dry powder long-acting single inhalation of a LABA and a LAMA (IND/GLY) was not superior compared to nebulized short-acting salbutamol plus ipratropium (SAL/IPR) in its bronchodilating effects over 6 h.The effects of the nebulization kicked in faster and peaked higher. The observed differences may be caused by the difference in dosing between the two regimens. The improvement in Borg dyspnoea score did not favour the nebulization. Long-term outcomes were not assessed in this study.",2020,"No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
","['chronic obstructive pulmonary disease', '33 COPD patients', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with stable COPD']","['IND', 'Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium', 'salbutamol plus ipratropium (SAL/IPR', 'indacaterol/glycopyrronium 110/50\xa0μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5\xa0mg via air driven nebulization (SAL/IPR', 'placebo', 'nebulized short-acting dual bronchodilator (salbutamol/ipratropium']","['area under the FEV 1  curve', 'Borg score, or adverse events', 'peak in FEV1', 'Borg dyspnoea score', 'change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity', 'FEV 1  AUC 0-6\xa0h, 2965\xa0±']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0578554', 'cui_str': 'Inhaled bronchodilator therapy'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",33.0,0.528759,"No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
","[{'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Medical Centre Leeuwarden, Department of Respiratory Medicine, Leeuwarden, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands. Electronic address: wouter.van.geffen@znb.nl.'}, {'ForeName': 'Orestes A', 'Initials': 'OA', 'LastName': 'Carpaij', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Lotte F', 'Initials': 'LF', 'LastName': 'Westbroek', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Seigers', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Niemeijer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Vonk', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106064']
2919,32917495,Black beans and red kidney beans induce positive postprandial vascular responses in healthy adults: A pilot randomized cross-over study.,"BACKGROUND AND AIMS


Consuming pulses (dry beans, dry peas, chickpeas, lentils) over several weeks can improve vascular function and decrease cardiovascular disease risk; however, it is unknown whether pulses can modulate postprandial vascular responses. The objective of this study was to compare different bean varieties (black, navy, pinto, red kidney) and white rice for their acute postprandial effects on vascular and metabolic responses in healthy individuals.
METHODS AND RESULTS


The study was designed as a single-blinded, randomized crossover trial with a minimum 6 days between consumption of the food articles. Vascular tone (primary endpoint), haemodynamics and serum biochemistry (secondary endpoints) were measured in 8 healthy adults before and at 1, 2, and 6 h after eating ¾ cup of beans or rice. Blood pressure and pulse wave velocity (PWV) were lower at 2 h following red kidney bean and pinto bean consumption compared to rice and navy bean, respectively (p < 0.05). There was greater vasorelaxation 6 h following consumption of darker-coloured beans, as shown by decreased vascular tone: PWV was lower after consuming black bean compared to pinto bean, augmentation pressure was lower after consuming black bean compared to rice and pinto bean, and wave reflection magnitude was lower after consuming red kidney bean and black bean compared to rice, navy bean, and pinto bean (p < 0.05). LDL-cholesterol concentrations were lower 6 h after black bean consumption compared to rice (p < 0.05).
CONCLUSION


Overall, red kidney and black beans, the darker-coloured beans, elicited a positive effect on the tensile properties of blood vessels, and this acute response may provide insight for how pulses modify vascular function.",2020,"Blood pressure and pulse wave velocity (PWV) were lower at 2 h following red kidney bean and pinto bean consumption compared to rice and navy bean, respectively (p < 0.05).","['healthy adults', 'healthy individuals']","['bean varieties (black, navy, pinto, red kidney) and white rice', 'Black beans and red kidney beans']","['vascular tone: PWV', 'LDL-cholesterol concentrations', 'vascular and metabolic responses', 'Blood pressure and pulse wave velocity (PWV', 'Vascular tone (primary endpoint), haemodynamics and serum biochemistry (secondary endpoints', 'Overall, red kidney and black beans', 'augmentation pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0324179', 'cui_str': 'Pinto'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0452712', 'cui_str': 'White rice'}, {'cui': 'C0973452', 'cui_str': 'Kidney Bean'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0004896', 'cui_str': 'Bean'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",8.0,0.0360441,"Blood pressure and pulse wave velocity (PWV) were lower at 2 h following red kidney bean and pinto bean consumption compared to rice and navy bean, respectively (p < 0.05).","[{'ForeName': 'Jaime L', 'Initials': 'JL', 'LastName': 'Clark', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, MB, R3T 2N2, Canada; Canadian Centre for Agri-Food Research in Health and Medicine, St. Boniface Hospital Albrechtsen Research Centre, Winnipeg, MB, R2H 2A6, Canada. Electronic address: jclark@sbrc.ca.'}, {'ForeName': 'Carla G', 'Initials': 'CG', 'LastName': 'Taylor', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, MB, R3T 2N2, Canada; Canadian Centre for Agri-Food Research in Health and Medicine, St. Boniface Hospital Albrechtsen Research Centre, Winnipeg, MB, R2H 2A6, Canada; Department of Physiology and Pathophysiology, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, R3E 0T5, Canada. Electronic address: ctaylor@sbrc.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zahradka', 'Affiliation': 'Department of Food and Human Nutritional Sciences, Faculty of Agricultural and Food Sciences, University of Manitoba, Winnipeg, MB, R3T 2N2, Canada; Canadian Centre for Agri-Food Research in Health and Medicine, St. Boniface Hospital Albrechtsen Research Centre, Winnipeg, MB, R2H 2A6, Canada; Department of Physiology and Pathophysiology, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, R3E 0T5, Canada. Electronic address: pzahradka@sbrc.ca.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.07.042']
2920,32917508,Using Guided Imagery to Relieve the Anxiety of Preschool Children Undergoing Dental Procedures.,"PURPOSE


Negative experiences in dental clinics can induce anxiety in patients, and the effects are particularly pronounced in children. When behavior guidance methods (eg, direct observation, tell-show-do, and ask-tell-ask) fail, general anesthesia is an important alternative; however, the procedure of anesthesia can also induce fear and anxiety. This study assessed the effectiveness of guided imagery in relieving the anxiety associated with dental surgery in children and caregivers.
DESIGN


A prospective randomized trial with two groups.
METHODS


The guided imagery in this study was meant to establish a rapport between the medical team and the patient, by encouraging the child to imagine having an adventure while riding in a spacecraft. Anxiety levels and behavior were measured using five well-established scales: the modified Yale Preoperative Scale-Short Form, the State-Trait Anxiety Inventory-6 items, the Watcha score, the Pediatric Anesthesia Emergent Delirium scale, and the Posthospitalization Behavioral Questionnaire-Ambulatory Surgery.
FINDINGS


The results indicate that the guided imagery had no significant effects on anxiety levels.
CONCLUSIONS


Guided imagery is a low-cost, easy-to-implement, interesting exercise capable of enhancing interactions between nursing staff and children. It may also help to condition children to the environment and thereby assist them in overcoming their fears.",2020,"CONCLUSIONS


Guided imagery is a low-cost, easy-to-implement, interesting exercise capable of enhancing interactions between nursing staff and children.","['children and caregivers', 'Preschool Children Undergoing Dental Procedures']","['Guided Imagery', 'guided imagery']","['anxiety levels', 'Anxiety levels and behavior', 'modified Yale Preoperative Scale-Short Form, the State-Trait Anxiety Inventory-6 items, the Watcha score, the Pediatric Anesthesia Emergent Delirium scale, and the Posthospitalization Behavioral Questionnaire-Ambulatory Surgery']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]",,0.0188963,"CONCLUSIONS


Guided imagery is a low-cost, easy-to-implement, interesting exercise capable of enhancing interactions between nursing staff and children.","[{'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesia, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'An-Hsun', 'Initials': 'AH', 'LastName': 'Chou', 'Affiliation': 'Department of Anesthesia, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Department of Medicine, Chang Gung University, Linkou, Taipei, Taiwan; Department of Anesthesiology, Xiamen Chang Gung Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Chia-Fen', 'Initials': 'CF', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesia, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Yu', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesia, Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, Taiwan; Department of Medicine, Chang Gung University, Linkou, Taipei, Taiwan. Electronic address: an5376@cgmh.org.tw.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.04.007']
2921,32917529,"Impact of Size and Location of Metastases on Early Tumor Shrinkage and Depth of Response in Patients With Metastatic Colorectal Cancer: Subgroup Findings of the Randomized, Open-Label Phase 3 Trial FIRE-3/AIO KRK-0306.","BACKGROUND


The Response Evaluation Criteria in Solid Tumors (RECIST) are used to define degrees of response to chemotherapy. For accelerated response evaluation, early tumor shrinkage (ETS) of ≥ 20% has been suggested as a predictor for outcome in metastatic colorectal cancer (mCRC). Together with depth of response (DpR), new alternative metrics have been provided, yielding promising outcome parameters. In this analysis, we aimed to further characterize ETS and DpR.
PATIENTS AND METHODS


This analysis was based on FIRE-3, a randomized phase 3 trial comparing first-line FOLFIRI plus either cetuximab or bevacizumab in KRAS exon 2 wild-type mCRC. ETS and DpR were determined on the basis of RECIST 1.1 in a blinded radiologic review. ETS was evaluated as a categorized (≥ 20% shrinkage) and continuous parameter. The impact of baseline location and size of metastases on ETS and DpR were evaluated by univariate and multivariate analyses.
RESULTS


Of 592 patients, 395 (66.7%) had data available for radiologic review. Median continuous ETS for lung, liver, and suspected lymph node metastases was 20%, 23%, and 30%, respectively. The median DpR was -32%, -44%, and -50%, respectively (all P < .01). In multivariate analysis, lung metastases were significantly associated with inferior DpR (P = .021), whereas hepatic metastases led to higher DpR (P = .024). Large metastases were associated with favorable ETS, whereas small metastases were correlated with higher DpR (P < .001).
CONCLUSION


ETS and DpR depend on the location and size of metastases in mCRC. These associations may establish the basis for further research to optimize the predictive accuracy of both parameters. This may help basing treatment decisions on ETS and DpR.",2020,"Large metastases were associated with favorable ETS, whereas small metastases were correlated with higher DpR (P < .001).
","['metastatic colorectal cancer (mCRC', 'Patients', 'Of 592 patients, 395 (66.7%) had data available for radiologic review']",['cetuximab or bevacizumab'],"['ETS and DpR', 'median DpR', 'Median continuous ETS for lung, liver, and suspected lymph node metastases', 'Early Tumor Shrinkage and Depth of Response']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}]",592.0,0.0550902,"Large metastases were associated with favorable ETS, whereas small metastases were correlated with higher DpR (P < .001).
","[{'ForeName': 'Matthias F', 'Initials': 'MF', 'LastName': 'Froelich', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany; Department of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Mannheim, Germany.'}, {'ForeName': 'Elina L', 'Initials': 'EL', 'LastName': 'Petersen', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany; Institute of Medical Informatics, Biometry and Epidemiology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Germany; Comprehensive Cancer Center Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Nörenberg', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany; Department of Clinical Radiology and Nuclear Medicine, University Medical Center Mannheim, Mannheim, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Hesse', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Alena B', 'Initials': 'AB', 'LastName': 'Gesenhues', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Department of Medicine, Division of Hematology, Oncology and Tumor Immunology (CCM), Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Wieland H', 'Initials': 'WH', 'LastName': 'Sommer', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Felix O', 'Initials': 'FO', 'LastName': 'Hofmann', 'Affiliation': 'Department of Radiology, University Hospital, LMU Munich, Munich, Germany; Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Department of Medicine, Division of Hematology, Oncology and Tumor Immunology (CCM), Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Germany; Comprehensive Cancer Center Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich and German Cancer Research Centre (DKFZ), Heidelberg, Germany. Electronic address: julian.holch@med.uni-muenchen.de.'}]",Clinical colorectal cancer,['10.1016/j.clcc.2020.06.005']
2922,32917540,A Randomized Prospective Blinded Study Evaluating the Effect of Music on Novice Surgical Trainees' Ability to Perform a Simulated Surgical Task.,"OBJECTIVE


To determine if playing music would affect novice surgical trainees' ability to perform a complex surgical task.
BACKGROUND


The effect of music in the operating room (OR) is controversial. Some studies from the anesthesiology literature suggest that OR music is distracting and should be banned. Other nonblinded studies have indicated that music improves surgeons' efficiency with simple tasks.
DESIGN/METHODS


A prospective, blinded, randomized trial of 19 novice surgical trainees was conducted using an in vitro model. Each trainee performed a baseline vascular anastomosis (VA) without music. Subsequently, they performed one VA with music (song validated to reduce anxiety) and one without, in random order and without prior knowledge of the study's purpose. The primary endpoint was a difference in differences from baseline with and without music with respect to time to completion, acceleration/deceleration (using a previously validated hand-tracking motion device), and video performance scoring (3 blinded experts using a validated scale). The participants completed a poststudy survey to gauge their opinions regarding music during tasks.
RESULTS


Overall, 57 VAs by 19 trainees were evaluated. Average time to completion was 11.6 minutes. When compared to baseline, time to completion improved for both the music group (p = 0.01) and no-music group (p = 0.001). When comparing music to no music, there was no difference in time to completion (p = 0.7), acceleration/deceleration (p = 0.3), or video performance scorings (p = NS). Among participants, 89% responded that they enjoy listening to music while performing tasks.
CONCLUSIONS


Using three outcome measures, relaxing music did not improve the performance of novice surgical trainees performing a complex surgical task, and the music did not make their performance worse. However, nearly all trainees reported enjoying listening to music while performing tasks.",2020,"Using three outcome measures, relaxing music did not improve the performance of novice surgical trainees performing a complex surgical task, and the music did not make their performance worse.",['19 novice surgical trainees'],"['Music', 'playing music', 'relaxing music']","['time to completion, acceleration/deceleration (using a previously validated hand-tracking motion device), and video performance scoring', 'video performance scorings', 'performance of novice surgical trainees performing a complex surgical task, and the music did not make their performance worse', 'time to completion']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",19.0,0.517907,"Using three outcome measures, relaxing music did not improve the performance of novice surgical trainees performing a complex surgical task, and the music did not make their performance worse.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shover', 'Affiliation': 'Department of Surgery, Harbor-UCLA Medical Center, Torrance, California.'}, {'ForeName': 'Janell', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, California; Charles R. Drew University of Medicine and Science College of Medicine, Los Angeles, California.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dauphine', 'Affiliation': 'Department of Surgery, Harbor-UCLA Medical Center, Torrance, California; The Lundquist Institute, Torrance, California.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Benharash', 'Affiliation': 'Division of Cardiac Surgery at University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Hanning', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, California.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Kansal', 'Affiliation': 'Department of Surgery, Harbor-UCLA Medical Center, Torrance, California; The Lundquist Institute, Torrance, California.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bowens', 'Affiliation': 'Department of Surgery, Harbor-UCLA Medical Center, Torrance, California; The Lundquist Institute, Torrance, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Archie', 'Affiliation': 'Department of Surgery, Harbor-UCLA Medical Center, Torrance, California; The Lundquist Institute, Torrance, California.'}, {'ForeName': 'Amy H', 'Initials': 'AH', 'LastName': 'Kaji', 'Affiliation': 'Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California; The Lundquist Institute, Torrance, California.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'de Virgilio', 'Affiliation': 'Department of Surgery, Harbor-UCLA Medical Center, Torrance, California; The Lundquist Institute, Torrance, California. Electronic address: cdevirgilio@lundquist.org.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.08.020']
2923,32918827,Schisto and Ladders version 2: a health educational board game to support compliance with school-based mass drug administration with praziquantel - a pilot study.,"BACKGROUND


We redesigned the Schisto and Ladders health educational board game and evaluated its potential to encourage compliance to school-based mass drug administration with praziquantel.
METHODS


Two hundred and seventy-five children from six schools who rejected praziquantel treatment were divided into intervention and control groups. Before the intervention, preassessment interviews were conducted on their knowledge about praziquantel treatment and schistosomiasis. The Schisto and Ladders version 2 game as an intervention, and the Snakes and Ladders game as a control, were played for 6 mo. Postassessment interviews, including focus group discussions, were conducted.
RESULTS


At preassessment, 0/98 (0.0%) children in the intervention group had heard of praziquantel compared with 2/177 (1.1%) in the control group. Similarly, 0/98 (0.0%) children in the intervention group did not know that praziquantel does not kill compared with 4/177 (2.3%) in the control group. The postassessment showed that 53/78 (67.9%) in the intervention group were aware of praziquantel compared with 2/177 (1.1%) in the control group (p=0.000). Similarly, 53 (69.7%) in the intervention group knew about the safety of praziquantel compared with 0/177 (0.0%) in the control group (p=0.000). Sixty-four children (65.3%) from the intervention group sought praziquantel treatment after the trial.
CONCLUSIONS


Schisto and Ladders version 2 is a useful sensitisation tool with which to encourage compliance to praziquantel treatment in schools.",2020,"Sixty-four children (65.3%) from the intervention group sought praziquantel treatment after the trial.
",['Two hundred and seventy-five children from six schools who rejected praziquantel treatment'],"['praziquantel', 'health educational board game']",[],"[{'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319517', 'cui_str': 'Order rejected'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],275.0,0.0264757,"Sixty-four children (65.3%) from the intervention group sought praziquantel treatment after the trial.
","[{'ForeName': 'Cynthia Uchechukwu', 'Initials': 'CU', 'LastName': 'Ejike', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Nigeria.'}, {'ForeName': 'Akinola Stephen', 'Initials': 'AS', 'LastName': 'Oluwole', 'Affiliation': 'COUNTDOWN implementation research Consortium, Ogun State.'}, {'ForeName': 'Olaitan Olamide', 'Initials': 'OO', 'LastName': 'Omitola', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Nigeria.'}, {'ForeName': 'Adedotun Ayodeji', 'Initials': 'AA', 'LastName': 'Bayegun', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Nigeria.'}, {'ForeName': 'Islamiat Yetunde', 'Initials': 'IY', 'LastName': 'Shoneye', 'Affiliation': 'Neglected Tropical Diseases Unit, Ogun State Ministry of Health, Oke-Mosan, Abeokuta, Nigeria.'}, {'ForeName': 'Bolanle Idowu', 'Initials': 'BI', 'LastName': 'Akeredolu-Ale', 'Affiliation': 'Department of Communication and General Studies, Federal University of Agriculture, Abeokuta, Nigeria.'}, {'ForeName': 'Oluwafunmilayo Aduke', 'Initials': 'OA', 'LastName': 'Idowu', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Nigeria.'}, {'ForeName': 'Chiedu Felix', 'Initials': 'CF', 'LastName': 'Mafiana', 'Affiliation': 'Research Administration and Advancement, National Open University of Nigeria, Abuja, Nigeria.'}, {'ForeName': 'Uwem Friday', 'Initials': 'UF', 'LastName': 'Ekpo', 'Affiliation': 'Department of Pure and Applied Zoology, Federal University of Agriculture, Abeokuta, Nigeria.'}]",International health,['10.1093/inthealth/ihaa057']
2924,32918853,Mediterranean Diet and Atherothrombosis Biomarkers: A Randomized Controlled Trial.,"SCOPE


To assess whether following a Mediterranean diet (MedDiet) improved atherothrombosis biomarkers in high cardiovascular risk individuals.
METHODS AND RESULTS


In 358 random volunteers from the PREvención con DIeta MEDiterránea trial, we assessed the 1-year effects on atherothrombosis markers of an intervention with MedDiet, enriched with virgin olive oil (MedDiet-VOO; n = 120) or nuts (MedDiet-Nuts; n = 119) versus a low-fat control diet (n = 119). We also studied whether large increments in MedDiet adherence (≥3 score points, relative to compliance decreases) and intake changes in key food items were associated with 1-year differences in biomarkers. We observed differences between 1-year changes in the MedDiet-VOO intervention and control diet on the activity of platelet activating factor acetylhydrolase in HDLs (+7.5% [95% confidence interval: 0.17; 14.8]) and HDL-bound α 1  -antitrypsin levels (-6.1% [-11.8; -0.29]), and between the MedDiet-Nuts intervention and the control arm on non-esterified fatty acid concentrations (-9.3% [-18.1; -0.53]). Large MedDiet adherence increments were associated with less fibrinogen (-9.5% [-18.3; -0.60]) and non-esterified fatty acid concentrations (-16.7% [-31.7; -1.74]). Increases in nut, fruit, vegetable, and fatty fish consumption, and decreases in processed meat intake were linked to beneficial changes in atherothrombosis biomarkers.
CONCLUSION


Following a MedDiet improved atherothrombosis biomarkers in high cardiovascular risk individuals. This article is protected by copyright. All rights reserved.",2020,Large MedDiet adherence increments were associated with less fibrinogen (-9.5% [-18.3; -0.60]) and non-esterified fatty acid concentrations (-16.7% [-31.7;,"['358 random volunteers from the PREvención con DIeta MEDiterránea trial', 'high cardiovascular risk individuals', 'Mediterranean Diet and Atherothrombosis Biomarkers']","['virgin olive oil (MedDiet-VOO; n = 120) or nuts (MedDiet-Nuts; n = 119) versus a low-fat control diet', 'Mediterranean diet (MedDiet']","['HDL-bound α 1  -antitrypsin levels', 'nut, fruit, vegetable, and fatty fish consumption', 'non-esterified fatty acid concentrations', 'atherothrombosis biomarkers', 'MedDiet adherence']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C1963943', 'cui_str': 'Atherothrombosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C2713669', 'cui_str': 'SERPINA5 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1963943', 'cui_str': 'Atherothrombosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",358.0,0.0899458,Large MedDiet adherence increments were associated with less fibrinogen (-9.5% [-18.3; -0.60]) and non-esterified fatty acid concentrations (-16.7% [-31.7;,"[{'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Hernáez', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tresserra-Rimbau', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pintó', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martínez-González', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Lapetra', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Gómez-Gracia', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Arós', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Fiol', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Lluis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'CIBER of Pathophysiology of Obesity and Nutrition (CIBEROBN), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'Cardiovascular Risk, Nutrition and Aging Research Unit, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000350']
2925,32918892,"Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial.","BACKGROUND


Despite inhaled corticosteroid plus long-acting β 2 -agonist (ICS/LABA) therapy, 30-50% of patients with moderate or severe asthma remain inadequately controlled. We investigated the safety and efficacy of single-inhaler fluticasone furoate plus umeclidinium plus vilanterol (FF/UMEC/VI) compared with FF/VI.
METHODS


In this double-blind, randomised, parallel-group, phase 3A study (Clinical Study in Asthma Patients Receiving Triple Therapy in a Single Inhaler [CAPTAIN]), participants were recruited from 416 hospitals and primary care centres across 15 countries. Participants were eligible if they were aged 18 years or older, with inadequately controlled asthma (Asthma Control Questionnaire [ACQ]-6 score of ≥1·5) despite ICS/LABA, a documented health-care contact or a documented temporary change in asthma therapy for treatment of acute asthma symptoms in the year before screening, pre-bronchodilator FEV 1  between 30% and less than 85% of predicted normal value, and reversibility (defined as an increase in FEV 1  of ≥12% and ≥200 mL in the 20-60 min after four inhalations of albuterol or salbutamol) at screening. Participants were randomly assigned (1:1:1:1:1:1), via central based randomisation stratified by pre-study ICS dose at study entry, to once-daily FF/VI (100/25 μg or 200/25 μg) or FF/UMEC/VI (100/31·25/25 μg, 100/62·5/25 μg, 200/31·25/25 μg, or 200/62·5/25 μg) administered via Ellipta dry powder inhaler (Glaxo Operations UK, Hertfordshire, UK). Patients, investigators, and the funder were masked to treatment allocation. Endpoints assessed in the intention-to-treat population were change from baseline in clinic trough FEV 1  at week 24 (primary) and annualised moderate and/or severe asthma exacerbation rate (key secondary). Other secondary endpoints were change from baseline in clinic FEV 1  at 3 h post-dose, St George's Respiratory Questionnaire (SGRQ) total score, and ACQ-7 total score, all at week 24. Change from baseline in Evaluating Respiratory Symptoms in Asthma total score at weeks 21-24 was also a secondary endpoint but is not reported here. Exploratory analyses of biomarkers of type 2 airway inflammation on treatment response were also done. This study is registered with ClinicalTrials.gov, NCT02924688, and is now complete.
FINDINGS


Between Dec 16, 2016, and Aug 31, 2018, 5185 patients were screened and 2439 were recruited and randomly assigned to FF/VI (100/25 μg n=407; 200/25 μg n=406) or FF/UMEC/VI (100/31·25/25 μg n=405; 100/62·5/25 μg n=406; 200/31·25/25 μg n=404; 200/62·5/25 μg n=408), with three patients randomly assigned in error and not included in analyses. In the intention-to-treat population, 922 (38%) patients were men, the mean age was 53·2 years (SD 13·1) and body-mass index was 29·4 (6·6). Baseline demographics were generally similar across all treatment groups. The least squares mean improvement in FEV 1  change from baseline for FF/UMEC/VI 100/62·5/25 μg versus FF/VI 100/25 μg was 110 mL (95% CI 66-153; p<0·0001) and for 200/62·5/25 μg versus 200/25 μg was 92 mL (49-135; p<0·0001). Adding UMEC 31·25 μg to FF/VI produced similar improvements (FF/UMEC/VI 100/31·25/25 μg vs FF/VI 100/25 μg: 96 mL [52-139; p<0·0001]; and 200/31·25/25 μg vs 200/25 μg: 82 mL [39-125; p=0·0002]). These results were supported by the analysis of clinic FEV 1  at 3 h post-dose. Non-significant reductions in moderate and/or severe exacerbation rates were observed for FF/UMEC 62·5 μg/VI versus FF/VI (pooled analysis), with rates lower in FF 200 μg-containing versus FF 100 μg-containing treatment groups. All pooled treatment groups demonstrated mean improvements (decreases) in SGRQ total score at week 24 compared with baseline in excess of the minimal clinically important difference of 4 points; however, there were no differences between treatment groups. For mean change from baseline to week 24 in asthma control questionnaire-7 score, improvements (decreases) exceeding the minimal clinically important difference of 0·5 points were observed in all pooled treatment groups. Adding UMEC to FF/VI resulted in small, dose-related improvements compared with FF/VI (pooled analysis: FF/UMEC 31·25 μg/VI versus FF/VI, -0·06 (95% CI -0·12 to 0·01; p=0·094) FF/UMEC 62·5 μg/VI versus FF/VI, -0·09 (-0·16 to -0·02, p=0·0084). By contrast with adding UMEC, the effects of higher dose FF on clinic trough FEV 1  and annualised moderate and/or severe exacerbation rate were increased in patients with higher baseline blood eosinophil count and exhaled nitric oxide. Occurrence of adverse events was similar across treatment groups (patients with at least one event ranged from 210 [52%] to 258 [63%]), with the most commonly reported adverse events being nasopharyngitis (51 [13%]-63 [15%]), headache (19 [5%]-36 [9%]), and upper respiratory tract infection (13 [3%]-24 [6%]). The incidence of serious adverse events was similar across all groups (range 18 [4%]-25 [6%)). Three deaths occurred, of which one was considered to be related to study drug (pulmonary embolism in a patient in the FF/UMEC/VI 100/31·25/25 μg group).
INTERPRETATION


In patients with uncontrolled moderate or severe asthma on ICS/LABA, adding UMEC improved lung function but did not lead to a significant reduction in moderate and/or severe exacerbations. For such patients, single-inhaler FF/UMEC/VI is an effective treatment option with a favourable risk-benefit profile. Higher dose FF primarily reduced the rate of exacerbations, particularly in patients with raised biomarkers of type 2 airway inflammation. Further confirmatory studies into the differentiating effect of type 2 inflammatory biomarkers on treatment outcomes in asthma are required to build on these exploratory findings and further guide clinical practice.
FUNDING


GSK.",2020,"All pooled treatment groups demonstrated mean improvements (decreases) in SGRQ total score at week 24 compared with baseline in excess of the minimal clinically important difference of 4 points; however, there were no differences between treatment groups.","['100/25 μg', '100/31·25/25 μg n=405; 100/62·5/25 μg n=406', 'Asthma Patients Receiving Triple Therapy in a Single Inhaler [CAPTAIN]), participants were recruited from 416 hospitals and primary care centres across 15 countries', 'patients with moderate or severe asthma remain inadequately controlled', 'Participants were eligible if they were aged 18 years or older, with inadequately controlled asthma (Asthma Control Questionnaire [ACQ]-6 score of ≥1·5) despite ICS/LABA, a documented health-care contact or a documented temporary change in asthma therapy for treatment of acute asthma symptoms in the year before screening, pre-bronchodilator FEV 1  between 30% and less than 85% of predicted normal value, and reversibility (defined as an increase in FEV 1  of ≥12% and ≥200 mL in the 20-60 min after four inhalations of', '922 (38%) patients were men, the mean age was 53·2 years (SD 13·1) and body-mass index was 29·4 ', 'Between Dec 16, 2016, and Aug 31, 2018, 5185 patients were screened and 2439 were recruited and randomly assigned to FF/VI ', 'patients with inadequately controlled asthma (CAPTAIN']","['single-inhaler fluticasone furoate plus umeclidinium plus vilanterol (FF/UMEC/VI', 'albuterol or salbutamol', 'once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI', 'FF/UMEC/VI ', '200/31·25/25']","['headache', 'upper respiratory tract infection', 'incidence of serious adverse events', 'intention-to-treat population', 'SGRQ total score', ""clinic FEV 1  at 3 h post-dose, St George's Respiratory Questionnaire (SGRQ) total score, and ACQ-7 total score"", 'safety and efficacy', 'adverse events being nasopharyngitis', 'lung function', 'Occurrence of adverse events', 'Efficacy and safety', 'annualised moderate and/or severe asthma exacerbation rate', 'clinic trough FEV 1  and annualised moderate and/or severe exacerbation rate', 'rate of exacerbations', 'moderate and/or severe exacerbation rates', 'moderate and/or severe exacerbations']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0086715', 'cui_str': 'Normal range'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4521397', 'cui_str': 'US Military Commissioned Officer O6'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",5185.0,0.793234,"All pooled treatment groups demonstrated mean improvements (decreases) in SGRQ total score at week 24 compared with baseline in excess of the minimal clinically important difference of 4 points; however, there were no differences between treatment groups.","[{'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'Lee', 'Affiliation': 'GlaxoSmithKline (GSK), Collegeville, PA, USA.'}, {'ForeName': 'Zelie', 'Initials': 'Z', 'LastName': 'Bailes', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'GSK, Brentford, Middlesex, UK; Barts and the London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Louis-Philippe', 'Initials': 'LP', 'LastName': 'Boulet', 'Affiliation': 'Laval University, Quebec, QC, Canada.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen and University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, Netherlands.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kerwin', 'Affiliation': 'Crisor, Clinical Research Institute, Medford, OR, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Asthma & Allergy Associates, PC and Research Center, Colorado Springs, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oppenheimer', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline (GSK), Collegeville, PA, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brusselle', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Peachey', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Sule', 'Affiliation': 'GlaxoSmithKline (GSK), Collegeville, PA, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Tabberer', 'Affiliation': 'GSK, Stockley Park West, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Nuffield Department of Medicine and Oxford Respiratory NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30389-1']
2926,32918899,Effect of normobaric hypoxia on exercise performance in pulmonary hypertension - randomized trial.,"BACKGROUND


Many patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension (PH) wish to travel to altitude or by airplane, but their risk of hypoxia-related adverse health effects is insufficiently explored.
RESEARCH QUESTION


How does hypoxia compared to normoxia affect constant-work-rate-exercise-test (CWRET)-time in PH-patients and which physiological mechanisms are involved?
STUDY DESIGN


and Methods: Stable PH-patients with resting PaO 2  ≥7.3kPa underwent symptom-limited cycle CWRET (60%Wmax) whilst breathing normobaric hypoxic (hypoxia, FiO 2 :15%) and ambient air (normoxia, FiO 2 :21%) in a randomized cross-over design. Borg-dyspnea, arterial blood gases, tricuspid regurgitation pressure gradient (TRPG) and mean pulmonary artery pressure/cardiac output ratio (mPAP/CO) by echocardiography were assessed before and end-CWRET.
RESULTS


28 patients (13 women), median(quartiles) age 66(54;74)years, mean pulmonary artery pressure 41(29;49)mmHg, and pulmonary vascular resistance 5.4(4;8)WU were included. Under normoxia and hypoxia, CWRET-time were 16.9(8.0;30.0) and 6.7(5.5;27.3) min, median difference (95%CI) -0.7(-3.1 to 0.0) min corresponding to -7(-32 to 0.0)%, p=0.006. At end-exercise in normoxia and hypoxia, median values and differences in corresponding variables were: PaO 2  8.0 vs. 6.4, -1.7(-2.7 to -1.1) kPa; arterial oxygen content 19.2 vs. 17.2, -1.7(-3 to -0.1) ml/dl; PaCO 2  4.7 vs. 4.3, -0.3(-0.5 to -0.1) kPa; lactate 3.7 vs. 3.7, 0.9(0.1 to 1.6) mmol/l, p<0.05 all differences. Borg-scale 7 vs. 6, 0.5(0 to 1), tricuspid pressure gradient 89 vs. 77 -3(-9 to 16) mmHg and mPAP/CO 4.5 vs. 3.3, 0.3(-0.8 to 1.4) WU remained unchanged. In multivariable regression, baseline PVR was the sole predictor of hypoxia-induced change in CWRET-time.
INTERPRETATION


In PH-patients, short-time exposure to hypoxia was well tolerated but reduced CWRET-time compared to normoxia in association with hypoxemia, lactacidemia and hypocapnia. Since pulmonary hemodynamics and dyspnea at end-exercise remained unaltered, the hypoxia-induced exercise limitation may be due to a reduced oxygen delivery causing peripheral tissue hypoxia, augmented lactic acid loading and hyperventilation.",2020,"ml/dl; PaCO 2  4.7 vs. 4.3, -0.3(-0.5 to -0.1) kPa","['and Methods: Stable PH-patients with resting PaO 2  ≥7.3kPa underwent symptom-limited cycle CWRET (60%Wmax) whilst breathing normobaric hypoxic (hypoxia, FiO 2 :15%) and ambient air (normoxia, FiO 2 :21', 'pulmonary hypertension - randomized trial', 'patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension (PH', '28 patients (13 women), median(quartiles) age 66(54;74)years, mean pulmonary artery pressure 41(29;49)mmHg, and pulmonary vascular resistance 5.4(4;8)WU were included']",['normobaric hypoxia'],"['Borg-dyspnea, arterial blood gases, tricuspid regurgitation pressure gradient (TRPG) and mean pulmonary artery pressure/cardiac output ratio (mPAP/CO', 'exercise performance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3854605', 'cui_str': 'Mean pulmonary arterial pressure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0561782,"ml/dl; PaCO 2  4.7 vs. 4.3, -0.3(-0.5 to -0.1) kPa","[{'ForeName': 'Schneider', 'Initials': 'S', 'LastName': 'Simon R', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland; Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland.'}, {'ForeName': 'Mayer', 'Initials': 'M', 'LastName': 'Laura C', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Lichtblau', 'Initials': 'L', 'LastName': 'Mona', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Berlier', 'Initials': 'B', 'LastName': 'Charlotte', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Schwarz', 'Initials': 'S', 'LastName': 'Esther I', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Saxer', 'Initials': 'S', 'LastName': 'Stéphanie', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Furian', 'Initials': 'F', 'LastName': 'Michael', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bloch', 'Initials': 'B', 'LastName': 'Konrad E', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Silvia', 'Affiliation': 'Clinic of Pulmonology, University Hospital of Zurich, Zurich, Switzerland. Electronic address: silvia.ulrich@usz.ch.'}]",Chest,['10.1016/j.chest.2020.09.004']
2927,32919405,Methylphenidate boosts choices of mental labor over leisure depending on striatal dopamine synthesis capacity.,"The cognitive enhancing effects of methylphenidate are well established, but the mechanisms remain unclear. We recently demonstrated that methylphenidate boosts cognitive motivation by enhancing the weight on the benefits of a cognitive task in a manner that depended on striatal dopamine. Here, we considered the complementary hypothesis that methylphenidate might also act by changing the weight on the opportunity cost of a cognitive task, that is, the cost of foregoing alternative opportunity. To this end, 50 healthy participants (25 women) completed a novel cognitive effort-discounting task that required choices between task and leisure. They were tested on methylphenidate, placebo, as well as the selective D2-receptor agent sulpiride, the latter to strengthen inference about dopamine receptor selectivity of methylphenidate's effects. Furthermore, they also underwent an [ 18 F]DOPA PET scan to quantify striatal dopamine synthesis capacity. Methylphenidate boosted choices of cognitive effort over leisure across the group, and this effect was greatest in participants with more striatal dopamine synthesis capacity. The effects of sulpiride did not reach significance. This study strengthens the motivational account of methylphenidate's effects on cognition, and suggests that methylphenidate reduces the cost of mental labor by increasing striatal dopamine.Fig. 1a Schematic of the color wheel working memory task. I = ""ignore"": participants have to ignore the new squares, while still remembering the previous set of squares. U = ""update"": participants have to remember the new set of squares and forget the previous set. b Example trial sequence of the cognitive effort discounting choice task. c Coronal view of our regions of interest, including the nucleus accumbens (blue), putamen (green), and caudate nucleus (red).Fig. 2a Median absolute deviance, b median response times, and c the proportion of trials on which participants chose the redo option across drug sessions plotted as a function of set size, separately for each task type. d Drug effect on the proportion of trials on which participants chose the redo option (methylphenidate or sulpiride minus placebo). The methylphenidate-induced effect on proportion redo choices is still significant without the participant showing the greatest effect: F (2,86)  = 4.0, p = 0.022. Error bars represent 95% confidence interval around the mean. MPH methylphenidate, SUL sulpiride, PBO placebo.Fig. 3PROPORTION REDO CHOICES AS A FUNCTION OF DOPAMINE SYNTHESIS CAPACITY IN THE NUCLEUS ACCUMBENS (UPPER PANELS), PUTAMEN (MIDDLE PANELS), AND CAUDATE NUCLEUS (BOTTOM PANELS).: P-values <0.017 were considered significant. a Correlation between dopamine synthesis capacity and proportion redo choices under placebo. b Correlation between dopamine synthesis capacity and drug-induced changes in proportion redo choices. Correlation coefficients and p-values without the participant showing the greatest methylphenidate-induced effect on proportion redo choices: r nucleus accumbens  = 0.36, p = 0.014; r putamen  = 0.41, p = 0.005; r caudate nucleus  = 0.29, p = 0.056. c Median split on dopamine synthesis capacity for visualization purposes. Shaded areas and error bars represent 95% confidence interval around the mean. PBO placebo, MPH methylphenidate, SUL sulpiride, K i  [ 18 F]DOPA uptake.Fig. 4CHOICE LATENCY AS A FUNCTION OF DOPAMINE SYNTHESIS CAPACITY IN THE NUCLEUS ACCUMBENS (UPPER PANELS), PUTAMEN (MIDDLE PANELS), AND CAUDATE NUCLEUS (BOTTOM PANELS).: p-Values <0.017 were considered significant. a Correlation between dopamine synthesis capacity and choice latency under placebo. b Correlation between dopamine synthesis capacity and drug-induced changes in choice latency. c Median split on dopamine synthesis capacity for visualization purposes. Shaded areas and error bars represent 95% confidence interval around the mean. PBO placebo, MPH methylphenidate, SUL sulpiride, K i  [ 18 F]DOPA uptake.",2020,The effects of sulpiride did not reach significance.,"['50 healthy participants (25 women', 'participants with more striatal dopamine synthesis capacity']","['redo option (methylphenidate or sulpiride minus placebo', 'novel cognitive effort-discounting task that required choices between task and leisure', 'I\u2009=\u2009""ignore', 'methylphenidate, placebo', 'Methylphenidate', 'MPH methylphenidate, SUL sulpiride, PBO placebo', 'placebo', 'methylphenidate']","['PBO placebo, MPH methylphenidate, SUL sulpiride, K i  [ 18 F]DOPA uptake', 'proportion redo choices', '2a Median absolute deviance, b median response times', 'cost of mental labor']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]","[{'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0038803', 'cui_str': 'Sulpiride'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]",50.0,0.0996967,The effects of sulpiride did not reach significance.,"[{'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Hofmans', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands. l.hofmans@donders.ru.nl.'}, {'ForeName': 'Danae', 'Initials': 'D', 'LastName': 'Papadopetraki', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'van den Bosch', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}, {'ForeName': 'Jessica I', 'Initials': 'JI', 'LastName': 'Määttä', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}, {'ForeName': 'Monja I', 'Initials': 'MI', 'LastName': 'Froböse', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}, {'ForeName': 'Bram B', 'Initials': 'BB', 'LastName': 'Zandbelt', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Westbrook', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}, {'ForeName': 'Robbert-Jan', 'Initials': 'RJ', 'LastName': 'Verkes', 'Affiliation': 'Department of Psychiatry, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'Cools', 'Affiliation': 'Donders Institute for Brain, Cognition & Behaviour, Radboud University, Nijśmegen, The Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00834-1']
2928,32919407,The effects of eszopiclone on sleep spindles and memory consolidation in schizophrenia: a randomized clinical trial.,"Sleep spindles, defining oscillations of stage 2 non-rapid eye movement sleep (N2), mediate memory consolidation. Schizophrenia is characterized by reduced spindle activity that correlates with impaired sleep-dependent memory consolidation. In a small, randomized, placebo-controlled pilot study of schizophrenia, eszopiclone (Lunesta®), a nonbenzodiazepine sedative hypnotic, increased N2 spindle density (number/minute) but did not significantly improve memory. This larger double-blind crossover study that included healthy controls investigated whether eszopiclone could both increase N2 spindle density and improve memory. Twenty-six medicated schizophrenia outpatients and 29 healthy controls were randomly assigned to have a placebo or eszopiclone (3 mg) sleep visit first. Each visit involved two consecutive nights of high density PSG with training on the Motor Sequence Task (MST) on the second night and testing the following morning. Patients showed a widespread reduction of spindle density and, in both groups, eszopiclone increased spindle density but failed to enhance sleep-dependent procedural memory consolidation. Follow-up analyses revealed that eszopiclone also affected cortical slow oscillations: it decreased their amplitude, increased their duration, and rendered their phase locking with spindles more variable. Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation. In conclusion, sleep oscillations are promising targets for improving memory consolidation in schizophrenia, but enhancing spindles is not enough. Effective therapies also need to preserve or enhance cortical slow oscillations and their coordination with thalamic spindles, an interregional dialog that is necessary for sleep-dependent memory consolidation.Fig. 1FINGER TAPPING MOTOR SEQUENCE TASK (MST) ADMINISTRATION AND RESULTS.: a Participants, randomized to the placebo or eszopiclone visit first, had an introductory/screening visit and two sleep visits, a week apart. Sleep visits involved polysomnography on two consecutive nights (Baseline, MST). Different MST sequences were employed for the two sleep visits and their order was counterbalanced within groups. There is no transfer of learning between MST sequences [83]. Participants trained on the MST before bedtime of the second night and were tested in the morning. Ten minutes after testing, participants trained on a new ""control"" sequence to evaluate the possibility of eszopiclone ""hangover"" effects on MST performance. Prior to each MST administration, participants completed the Stanford Sleepiness Scale (SSS) to measure subjective alertness [84]. b The MST requires participants to repeatedly type a five-digit sequence (e.g., 4-1-3-2-4) on a numerically labeled keyboard with the left hand, ""as quickly and accurately as possible"" for twelve 30 s trials separated by 30 s rest periods. The sequence is displayed at the top of the screen and dots appear beneath it with each keystroke. Participants train before sleep and test on an additional 12 trials after sleep. c Bar graphs of group differences in overnight MST improvement on placebo and eszopiclone with SE bars. Asterisk denotes p < 0.05. d Spindle density at electrode location Cz (inset) on the MST night plotted against overnight MST improvement by group for the placebo and e eszopiclone visits. f Density of spindle-SO events on the MST nights plotted against overnight MST improvement, averaged over the placebo and eszopiclone visits, in the cluster showing a significant correlation (inset). The regression line for the combined groups and visits is shown.Fig. 2ESZOPICLONE EFFECTS ON N2 SLEEP SPINDLE DENSITY.: a Topographical maps of spindle density averaged across nights of the placebo and eszopiclone visits for each group and the comparison of the two visits. Electrodes with a cluster-corrected p < 0.05 are highlighted in green. b Group difference maps (top and middle rows) show significantly greater spindle density in controls than patients on placebo (two significant clusters), but not eszopiclone. Electrodes highlighted in black correspond to p uncorrected  < 0.05. Bottom row: Group by Drug interaction showing electrodes where the eszopiclone effect of increasing spindle density was nonsignificantly greater in patients (p uncorrected  < 0.05). c Top: main effect of Group on spindle density showing a significant cluster. Middle: bar graph of spindle density averaged across the electrodes in the significant cluster with SE bars. Bottom: Drug main effect-eszopiclone increased spindle density at all electrodes.Fig. 3ESZOPICLONE EFFECTS ON N2 SOS AND THEIR COORDINATION WITH SPINDLES.: a Topographical maps of mean SO phase at spindle peak during the placebo and eszopiclone visits (averaged across groups and nights) and a statistical map of their difference. Electrodes highlighted in black meet a threshold of p uncorrected  < 0.05. Circular plots show SO phase at Cz. Lines represent the mean SO phase for each participant and their length represents the consistency of the spindle-SO phase locking. Arrows represent the group means. Right column: mapping of SO phase to topographical maps and circular plots. b Topographical maps of SO and spindle-SO coordination parameters during the placebo and eszopiclone visits and statistical maps of their difference. Electrodes with a cluster-corrected p < 0.05 are highlighted in green. c Plot of the relation of SO amplitude with spindle-SO phase consistency, averaged over the placebo and eszopiclone visits, in the cluster showing a significant correlation (inset shows significant cluster). Regression line is for the combined groups and drug visits.",2020,"Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation.","['Twenty-six medicated schizophrenia outpatients and 29 healthy controls', 'Bottom', 'schizophrenia']","['MST', 'placebo or eszopiclone', 'placebo', 'eszopiclone', 'schizophrenia, eszopiclone (Lunesta®']","['N2 spindle density and improve memory', 'cortical slow oscillations', 'Sleep visits involved polysomnography', 'overnight MST improvement', 'sleep spindles and memory consolidation', 'Stanford Sleepiness Scale (SSS', 'spindle density', 'MST night plotted against overnight MST improvement']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1436328', 'cui_str': 'Eszopiclone'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1579761', 'cui_str': 'Lunesta'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679057', 'cui_str': 'Memory Consolidation'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",,0.0911188,"Regardless of group or visit, the density of coupled spindle-slow oscillation events predicted memory consolidation significantly better than spindle density alone, suggesting that they are a better biomarker of memory consolidation.","[{'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Mylonas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Bengi', 'Initials': 'B', 'LastName': 'Baran', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Demanuele', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Cox', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Tessa C', 'Initials': 'TC', 'LastName': 'Vuper', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Seicol', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Parr', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Cameron E', 'Initials': 'CE', 'LastName': 'Callahan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Vangel', 'Affiliation': 'Department of Biostatistics, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stickgold', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Dara S', 'Initials': 'DS', 'LastName': 'Manoach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. dara.manoach@mgh.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-00833-2']
2929,32919416,"Sociodemographic, Lifestyle and Medical Factors Associated with Helicobacter Pylori Infection.","BACKGROUND AND AIMS


The prevalence of Helicobacter pylori (H. pylori) infection is higher in developing countries and is often linked to lower socioeconomic status. Few studies have investigated the association between H. pylori and individual level characteristics in Europe, where several countries have a high prevalence of H. pylori infection. The study aimed to identify risk factors for H. pylori infection among adults in a large clinical trial in Latvia.
METHODS


1,855 participants (40-64 years) of the ""Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality"" (GISTAR study) in Latvia tested for H. pylori IgG antibodies were included in a cross-sectional analysis. Sociodemographic, lifestyle and medical factors were compared for participants seropositive (H. pylori+) and seronegative. Mutually adjusted odds ratios (OR) were calculated for H. pylori+ and factors significant in univariate analysis (education, smoking, binge drinking, several dietary habits, history of H. pylori eradication and disease), adjusting for age, gender and income.
RESULTS


Of the participants 1,044 (55.4%) were H. pylori seropositive. The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (OR: 1.32; 95%CI: 1.03-1.69) and inversely with ≥400g vegetables/fruit daily (OR: 0.76; 95%CI: 0.60-0.96), history of H. pylori eradication (OR: 0.57; 95%CI: 0.39-0.84), peptic ulcer (OR: 0.55; 95%CI: 0.38-0.80) and cardiovascular disease (OR: 0.78; 95%CI: 0.61-0.99).
CONCLUSIONS


After mutual adjustment, H. pylori seropositivity was associated with lifestyle and in particular dietary factors rather than socioeconomic indicators in contrast to the majority of other studies.",2020,"The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (","['1,855 participants (40-64 years) of the ""Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality"" (GISTAR study) in Latvia tested for H. pylori IgG antibodies were included in a cross-sectional analysis', 'adults in a large clinical trial in Latvia']",[],"['Helicobacter pylori (H. pylori) infection', 'history of H. pylori eradication ', 'univariate analysis (education, smoking, binge drinking, several dietary habits, history of H. pylori eradication and disease', 'Mutually adjusted odds ratios (OR', 'peptic ulcer', 'cardiovascular disease']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030913', 'cui_str': 'Pepsinogen'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1277797', 'cui_str': 'Helicobacter pylori IgG antibody measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",1044.0,0.111375,"The infection was associated with current (OR: 1.34, 95%CI: 1.01-1.78) and former (OR: 1.38; 95%CI: 1.03-1.85) smoking, binge drinking (OR: 1.35; 95%CI: 1.03-1.78), having ≥200g dairy daily (OR: 1.37; 95%CI: 1.11-1.69), and very hot food/drinks (","[{'ForeName': 'Danute', 'Initials': 'D', 'LastName': 'Razuka-Ebela', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. d.razuka.ebela@gmail.com.'}, {'ForeName': 'Inese', 'Initials': 'I', 'LastName': 'Polaka', 'Affiliation': 'Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. inese.polaka@gmail.com.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Parshutin', 'Affiliation': 'Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. sergejs.parsutins@lu.lv.'}, {'ForeName': 'Daiga', 'Initials': 'D', 'LastName': 'Santare', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. daiga.santare@lu.lv.'}, {'ForeName': 'Inguna', 'Initials': 'I', 'LastName': 'Ebela', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia. inguna.ebela@gmail.com.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Murillo', 'Affiliation': 'Hospital Universitario San Ignacio, Bogota, Columbia. raulhmurillo@yahoo.com.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. rherrero@acibcr.com.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Tzivian', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga, Latvia; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia; Holon Institute of Technology, Holon, Israel. liliana.tz@gmail.com.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Young Park', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. ParkJY@iarc.fr.'}, {'ForeName': 'Marcis', 'Initials': 'M', 'LastName': 'Leja', 'Affiliation': 'Faculty of Medicine, University of Latvia, Riga; Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia. marcis.leja@lu.lv.'}]",Journal of gastrointestinal and liver diseases : JGLD,['10.15403/jgld-870']
2930,32919098,Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids.,"BACKGROUND


Opioid overdose prevention education and naloxone distribution (OEND) programs include information on general risk factors, overdose recognition, and naloxone utilization. This study evaluated a personally-tailored OEND (PTOEND) intervention designed to promote harm reduction and treatment readiness for illicit opioid users by also including education about personal overdose-risk factors and medication for opioid use disorder (MOUD).
METHOD


A secondary analysis of a randomized controlled trial testing a Peer recovery support service (PRSS) intervention, relative to Control, in adult illicit opioid users reporting treatment for an overdose in the prior 6 months. PTOEND, a 30-minute computer-guided intervention, was administered by a research assistant at the randomization visit to all participants (N = 80). Participants completed a telephone visit 3 weeks post-randomization (n = 74) to assess changes in opioid overdose/MOUD knowledge and treatment readiness. Participants completed in-person visits at 3 (n = 66), 6 (n = 58), and 12 (n = 44) months post-randomization to assess illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors (12 months). We conducted pre-post analyses of the impact of PTOEND controlling for the PRSS effect.
RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05). Self-reported opioid use was significantly decreased at each follow-up (all p < 0.01). Self-reported overdose-risk behaviors decreased significantly (6.2 to 2.4, p < 0.01). A majority of participants (65 %) reported naloxone utilization.
CONCLUSIONS


PTOEND may be effective for promoting harm reduction and treatment readiness.",2020,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","['adult illicit opioid users reporting treatment for an overdose in the prior 6 months', 'individuals actively using illicit opioids']","['naloxone distribution intervention', 'Peer recovery support service (PRSS) intervention']","['Self-reported overdose-risk behaviors', 'Self-reported opioid use', 'knowledge of overdose', 'illicit opioid use and naloxone utilization (all time points) and overdose-risk behaviors', 'desire to quit all substances', 'MOUD']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0332266', 'cui_str': 'Illicit'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]",80.0,0.027065,"RESULTS


PTOEND increased knowledge of overdose (79.8% to 81.5%, p < 0.05) and MOUD (66.9% to 75.0%, p < 0.01) and decreased perceived treatment barriers (2.1 to 1.9, p < 0.01); desire to quit all substances increased (7.2 to 7.8, p = 0.05).","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Winhusen', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA. Electronic address: winhusen@carc.uc.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wilder', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lyons', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati College of Medicine 231, Albert Sabin Way, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Theobald', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Kropp', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 3131 Harvey Avenue, Cincinnati, OH 45229, USA; Center for Addiction Research, University of Cincinnati College of Medicine, 3230 Eden Ave, Cincinnati, OH 45267, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108265']
2931,32919110,Fibroblast Growth Factor 23 concentrations and modifying factors in children from age 12 to 24 months.,"BACKGROUND AND OBJECTIVES


Fibroblast growth factor 23 (FGF23) participates in phosphate, calcium and vitamin D metabolism. In children these interactions and modifying factors are largely unknown.
PARTICIPANTS AND METHODS


This study evaluates temporal changes and modifiers of FGF23 concentrations from 12 to 24 months, in healthy children, participating in a randomized vitamin D intervention (VIDI). Participants received vitamin D 3  of 10 or 30 μg/day from age 2 weeks to 24 months. At 12 and 24 months, growth measurements and venous blood samples were obtained for analyses of intact (iFGF23) and C-terminal FGF23 (cFGF23), 25-hydroxyvitamin D (25-OHD), calcium, phosphate, parathyroid hormone, iron and ferritin. Changes in FGF23 and modifying factors were examined by linear mixed models.
RESULTS


The study included 594 infants. Girls had higher iFGF23 than boys (p<0.001 for both 12 and 24 months), cFGF23 did not differ between the sexes. Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002). Adjusted mean cFGF23 decreased from 2.89 to 2.00 pmol/L in boys (p<0.001) and from 2.92 to 1.93 pmol/L in girls (p<0.001). Iron modified FGF23 in both sexes, associating positively with iFGF23 and inversely with cFGF23. In girls, 25-OHD modified iFGF23. In boys, season modified FGF23, possibly through seasonal differences in 25-OHD. Vitamin D intervention dose did not affect FGF23.
CONCLUSIONS


FGF23 decreases from 12 to 24 months. Girls have higher iFGF23 than boys, at both time points. Iron modifies FGF23 in both sexes.",2020,Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002).,"['594 infants', 'healthy children, participating in a randomized vitamin D intervention (VIDI', 'children from age 12 to 24 months']","['Vitamin D intervention', 'vitamin D']","['intact (iFGF23) and C-terminal FGF23 (cFGF23), 25-hydroxyvitamin D (25-OHD), calcium, phosphate, parathyroid hormone, iron and ferritin', 'cFGF23', 'Adjusted mean cFGF23', 'Adjusted mean iFGF23', 'growth measurements and venous blood samples']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1829744', 'cui_str': 'Fibroblast growth factor 23, C-terminal'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C1859049', 'cui_str': 'Haddad syndrome'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}]",594.0,0.0908647,Adjusted mean iFGF23 decreased from 41.4 to 38.1 pg/mL in boys (p<0.001) and from 45.2 to 42.5 pg/mL in girls (p=0.002).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Enlund-Cerullo', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland. Electronic address: maria.enlund@helsinki.fi.""}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hauta-Alus', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Saara', 'Initials': 'S', 'LastName': 'Valkama', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Rosendahl', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}, {'ForeName': 'Sture', 'Initials': 'S', 'LastName': 'Andersson', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Mäkitie', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland; Center for Molecular Medicine, Karolinska Institutet, and Clinical Genetics, Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Holmlund-Suila', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Program for Clinical and Molecular Metabolism, Faculty of Medicine, University of Helsinki, Finland.""}]",Bone,['10.1016/j.bone.2020.115629']
2932,32919170,Is Moulage effective in improving clinical skills of nursing students for the assessment of pressure injury?,"BACKGROUND


In wound care simulations, the practice can be performed on 3D-wounds formed by moulage. Moulage helps the student to perceive the etiology, physiology, and healing processes of the wound, and it can also be used to improve the students' wound assessment skills.
OBJECTIVE


The aim of this study is to investigate the effectiveness of moulage in the improvement of pressure injury assessment skills of nursing students.
DESIGN


A quasi-experimental study.
SETTINGS


A nursing faculty at a public university.
PARTICIPANTS


All fourth-year students (n = 73) who take the simulation elective course were invited to participate.
METHODS


Fall semester students (n = 38) constituted the control group and spring semester students (n = 35) formed the intervention group. The coin-flipping method was used to match the education period and student groups. The intervention group simulation was performed using moulage, and the control group simulation was performed using a pressure ulcer visuals. The same simulation scenarios were used for both groups. The data were collected using the Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers.
RESULTS


Students' knowledge scores for pressure injury assessment have improved significantly in both the intervention group (pre-test:61.71 ± 9.77 and post-test 70.57 ± 12.53, t = -4.27, p < 0.001) and the control group (pre-test: 66.81 ± 13.47 and post-test 73.06 ± 15.50, t = -2.34, p = 0.02). Laboratory and clinical pressure injury assessment skill scores of the intervention group students were significantly higher than the control group. Besides, the correct staging percentages of the intervention group students are higher than the control group students during the clinical practice (χ2 = 5.05, p = 0.02).
CONCLUSIONS


It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.",2020,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"['All fourth-year students (n\xa0=\xa073) who take the simulation elective course were invited to participate', 'Fall semester students (n\xa0=\xa038) constituted the control group and spring semester students (n\xa0=\xa035) formed the intervention group', 'nursing students']",[],"['Laboratory and clinical pressure injury assessment skill scores', 'knowledge scores for pressure injury assessment', 'Simulation Design Scale, Student Satisfaction and Self-Confidence Scale, and student identification form, knowledge test, performance checklist and feedback form developed by the researchers']","[{'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]",[],"[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",73.0,0.0183299,It can be concluded that the simulation with moulage was effective in improving the skills of nursing students who received training for pressure injury assessment and in transferring what they learned to the clinical setting.,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Sezgunsay', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Training and Research Hospital, Stoma and Wound Care Center, Ankara.'}, {'ForeName': 'Tulay', 'Initials': 'T', 'LastName': 'Basak', 'Affiliation': 'University of Health Sciences Turkey, Gulhane Faculty of Nursing, Fundamentals of Nursing Department, Ankara. Electronic address: tulay.basak@sbu.edu.tr.'}]",Nurse education today,['10.1016/j.nedt.2020.104572']
2933,32919196,Understanding the composite dimensions of the EQ-5D: An experimental approach.,"The EQ-5D(-5L) includes two composite dimensions: ""Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D), which involves an inherent ambiguity. Little is known about how these composite dimensions are interpreted across contexts where (i) individuals self-report their own health; and (ii) individuals value stylised health states. We detail the nature of the ambiguity and present experimental evidence from two large online surveys (n = 1007 and n = 1415). In one survey, individuals reported both their current health and their health at the time they felt the worst because of their health. In the other, they valued stylised EQ-5D states using Discrete Choice Experiments with duration as an attribute. In both surveys, participants were randomised into treatments in which the presentation of one of the composite dimensions was altered, or a control. Our results suggest (1) In self-report, use of the composite dimensions differs across the dimensions, with P/D used mainly to report Pain, but A/D used mainly to mean the more severe component of Anxiety and Depression. (2) In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level. (3) In valuation, the composite dimension P/D was interpreted to mean Pain, whilst the composite dimension A/D was interpreted to lie between Anxiety and Depression. We conclude that care must be taken when interpreting responses to existing health (or wellbeing) descriptive systems that rely on composite dimensions, and that caution should be applied when designing new ones.",2020,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.",[],['EQ-5D'],"['Pain or Discomfort"" (P/D) and ""Anxiety or Depression"" (A/D', 'severe component of Anxiety and Depression']",[],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0204719,"In valuation, Pain was perceived to be worse than Discomfort at the same level, and Depression was perceived to be worse than Anxiety at the same level.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'University of Birmingham, UK. Electronic address: r.l.mcdonald@bham.ac.uk.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'Mullett', 'Affiliation': 'University of Warwick, UK.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Tsuchiya', 'Affiliation': 'University of Sheffield, UK.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113323']
2934,32919280,No benefit of HDL mimetic CER-001 on carotid atherosclerosis in patients with genetically determined very low HDL levels.,"BACKGROUND AND AIMS


Infusion of high-density lipoprotein (HDL) mimetics failed to induce regression of atherosclerosis in recent randomized clinical trials. However, patients in these previous trials had normal levels of HDL-cholesterol, which potentially limited efficacy. Patients with very low levels of HDL-cholesterol and impaired cholesterol efflux capacity can be expected to derive the most potential benefit from infusion of HDL mimetics. This randomized clinical trial evaluated the efficacy of infusions of the HDL mimetic CER-001 in patients with genetically determined very low levels of HDL cholesterol.
METHODS


In this multicenter, randomized clinical trial, we recruited patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants). Participants were randomized to intravenous infusions of 8 mg/kg CER-001 or placebo (2:1 ratio), comprising 9 weekly infusions followed by infusions every two weeks. Patients underwent repeated 3T-MRI to assess mean vessel wall area and  18 F-FDG PET/CT to quantify arterial wall inflammation.
RESULTS


A total of 30 patients with a mean age of 52.7 ± 7.4 years and HDL-cholesterol of 0.35 ± 0.25 mmol/L were recruited. After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21). Furthermore, there was no significant difference in carotid arterial wall inflammation (n = 24, treatment difference: 0.10 target-to-background ratio of the most diseased segment, p = 0.33) after 24 weeks.
CONCLUSION


In patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with HDL mimetic CER-001 did not reduce carotid vessel wall dimensions or arterial wall inflammation, compared with placebo.",2020,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","['patients with genetically determined very low HDL levels', 'patients with genetically determined very low levels of HDL cholesterol', '30 patients with a mean age of 52.7\xa0±\xa07.4 years and HDL-cholesterol of 0.35\xa0±\xa00.25\xa0mmol/L were recruited', 'patients with genetically determined very low HDL-cholesterol, 24 weeks of treatment with', 'patients with familial hypoalphalipoproteinemia (due to ABCA1 and/or APOA1 loss-of-function variants']","['placebo', 'HDL mimetic CER-001', 'intravenous infusions of 8\xa0mg/kg CER-001 or placebo', 'repeated 3T-MRI']","['carotid arterial wall inflammation', 'absolute change in mean vessel wall area', 'normal levels of HDL-cholesterol', 'carotid atherosclerosis', 'carotid vessel wall dimensions or arterial wall inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704429', 'cui_str': 'Familial hypoalphalipoproteinemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3711161', 'cui_str': 'ABCA1 protein, human'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205419', 'cui_str': 'Variant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C3884609', 'cui_str': 'CER-001'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1097281', 'cui_str': '3-(3,4-dimethoxyphenyl)-1H-1,2,4-triazole'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0507850', 'cui_str': 'Wall of artery'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.409435,"After 24 weeks, the absolute change in mean vessel wall area was not significantly different in the CER-001 group compared with placebo (n = 27; treatment difference: 0.77 mm 2 , p = 0.21).","[{'ForeName': 'Kang H', 'Initials': 'KH', 'LastName': 'Zheng', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Kaiser', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Casper C', 'Initials': 'CC', 'LastName': 'van Olden', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Raul D', 'Initials': 'RD', 'LastName': 'Santos', 'Affiliation': 'Lipid Clinic Heart Institute (InCor), University of Sao Paulo Medical School Hospital, Sao Paulo, Brazil; Hospital Israelita Albert Einstein, Sao Paulo, Brazil.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Dasseux', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Genest', 'Affiliation': 'Department of Medicine, Division of Cardiology, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'Department of Medicine, Université de Montréal, Chicoutimi, Quebec, Canada.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, Utrecht University Medical Center, Utrecht, the Netherlands.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Keyserling', 'Affiliation': 'Cerenis Therapeutics, Labège, Toulouse, France.'}, {'ForeName': 'Hein J', 'Initials': 'HJ', 'LastName': 'Verberne', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Center for Research, Prevention and Treatment of Atherosclerosis, Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hegele', 'Affiliation': 'Robarts Research Institute, Western University, London, Ontario, Canada.'}, {'ForeName': 'Olivier S', 'Initials': 'OS', 'LastName': 'Descamps', 'Affiliation': 'Centres Hospitaliers Jolimont, La Louvière, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Aart J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Erik S G', 'Initials': 'ESG', 'LastName': 'Stroes', 'Affiliation': 'Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, the Netherlands. Electronic address: e.s.stroes@amsterdamumc.nl.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.08.004']
2935,31206586,"Constructing a confidence interval for the fraction who benefit from treatment, using randomized trial data.","The fraction who benefit from treatment is the proportion of patients whose potential outcome under treatment is better than that under control. Inference on this parameter is challenging since it is only partially identifiable, even in our context of a randomized trial. We propose a new method for constructing a confidence interval for the fraction, when the outcome is ordinal or binary. Our confidence interval procedure is pointwise consistent. It does not require any assumptions about the joint distribution of the potential outcomes, although it has the flexibility to incorporate various user-defined assumptions. Our method is based on a stochastic optimization technique involving a second-order, asymptotic approximation that, to the best of our knowledge, has not been applied to biomedical studies. This approximation leads to statistics that are solutions to quadratic programs, which can be computed efficiently using optimization tools. In simulation, our method attains the nominal coverage probability or higher, and can have narrower average width than competitor methods. We apply it to a trial of a new intervention for stroke.",2019,"In simulation, our method attains the nominal coverage probability or higher, and can have narrower average width than competitor methods.",[],[],[],[],[],[],,0.0333052,"In simulation, our method attains the nominal coverage probability or higher, and can have narrower average width than competitor methods.","[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Huang', 'Affiliation': 'Department of Mathematics and Statistics, Wake Forest University, Winston Salem, North Carolina.'}, {'ForeName': 'Ethan X', 'Initials': 'EX', 'LastName': 'Fang', 'Affiliation': 'Department of Statistics, Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rosenblum', 'Affiliation': 'Department of Biostatistics, Johns Hopkins University, Baltimore, Maryland.'}]",Biometrics,['10.1111/biom.13101']
2936,31021112,Common variants of the oxytocin receptor gene do not predict the positive mood benefits of prosocial spending.,"Who benefits most from helping others? Previous research suggests that common polymorphisms of the oxytocin receptor gene (OXTR) predict whether people behave generously and experience increases in positive mood in response to socially focused experiences in daily life. Building on these findings, we conducted an experiment with a large, ethnically homogenous sample (N = 437) to examine whether individual differences in three frequently studied single nucleotide polymorphisms of OXTR (rs53576, rs2268498, rs2254298) also predict differences in the positive mood benefits of financial generosity. Consistent with past research, participants who were randomly assigned to purchase items for others (vs. themselves) reported greater positive affect. Contrary to predictions, using Bayesian statistics, we found conclusive evidence that the benefits of generosity were not moderated by individual differences in OXTR single nucleotide polymorphisms. The current work highlights the importance of publishing null results to build cumulative knowledge linking neurobiological factors to positive emotional experiences. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Contrary to predictions, using Bayesian statistics, we found conclusive evidence that the benefits of generosity were not moderated by individual differences in OXTR single nucleotide polymorphisms.",[],[],[],[],[],[],,0.324381,"Contrary to predictions, using Bayesian statistics, we found conclusive evidence that the benefits of generosity were not moderated by individual differences in OXTR single nucleotide polymorphisms.","[{'ForeName': 'Ashley V', 'Initials': 'AV', 'LastName': 'Whillans', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lara B', 'Initials': 'LB', 'LastName': 'Aknin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Ross', 'Affiliation': 'Department of Pharmaceutical Sciences.'}, {'ForeName': 'Lihan', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Frances S', 'Initials': 'FS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000589']
2937,31362999,Lactobacillus bulgaricus  improves antioxidant capacity of black garlic in the prevention of gestational diabetes mellitus: a randomized control trial.,"Objectives:   Lactobacillus bulgaricus  may improve antioxidant capacity of black garlic in the prevention of gestational diabetes mellitus (GDM). Methods:  Black garlic was prepared with or without  L. bulgaricus  Volatile and polysaccharides were analyzed by using LC-MS, Fourier Transform infrared (FTIR) and  13 C nuclear magnetic resonance (NMR). The study design was parallel randomized controlled trial and 226 GDM patients were randomly assigned into BG (black garlic and  L. bulgaricus ) and CG (black garlic) groups, and allocation ratio was 1:1. The treatment duration was 40 weeks. Fasting blood glucose (FBG) and 1- and 2-h blood glucose (1hBG and 2hBG) after oral glucose tolerance test (OGTT) were detected. Antioxidant function of black garlic was determined by measuring plasma malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-PX) and total antioxidant capacity (T-AOC) in GDM patients. The comparison between two groups was made using two independent samples  t  test. Results:  The intake of nutrients was similar between two groups ( P >0.05).  L. bulgaricus  promoted the transformation of the glucopyranoside to glucofuranoside.  L. bulgaricus  increased the abilities of black garlic for scavenging hydroxyl radicals, 2,2'-azino-bis (3-ethylbenzenthiazoline-6-sulfonic) acid (ABTS) and DPPH free radicals.  L. bulgaricus  reduced the levels of FBG, 1hBG and 2hBG, and incidence of perinatal complications ( P <0.01). Plasma MDA level in the BG group was lower than in the CG group, whereas the levels of SOD, GSH-PX and T-AOC in the BG group were higher than in the CG group ( P <0.01). Conclusions:   L. bulgaricus  improves antioxidant capacity of black garlic in the prevention of GDM.",2019,"Plasma MDA level in the BG group was lower than in the CG group, whereas the levels of SOD, GSH-PX and T-AOC in the BG group were higher than in the CG group ( P <0.01).","['226 GDM patients', 'gestational diabetes mellitus', 'GDM patients', 'gestational diabetes mellitus (GDM']","['Black garlic', 'BG (black garlic and  L. bulgaricus ) and CG (black garlic']","['levels of FBG, 1hBG and 2hBG, and incidence of perinatal complications', 'antioxidant capacity', 'Antioxidant function of black garlic', 'levels of SOD, GSH-PX and T-AOC', 'Fasting blood glucose (FBG) and 1- and 2-h blood glucose (1hBG and 2hBG) after oral glucose tolerance test (OGTT', "" 2,2'-azino-bis (3-ethylbenzenthiazoline-6-sulfonic) acid (ABTS) and DPPH free radicals"", 'plasma malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-PX) and total antioxidant capacity (T-AOC', 'Plasma MDA level', 'scavenging hydroxyl radicals', 'intake of nutrients']","[{'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0885057', 'cui_str': 'Garlic preparation'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0016693', 'cui_str': 'Free Radicals'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0017822', 'cui_str': 'Glutathione:hydrogen-peroxide oxidoreductase'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0063146', 'cui_str': 'Hydroxyl'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",,0.0441565,"Plasma MDA level in the BG group was lower than in the CG group, whereas the levels of SOD, GSH-PX and T-AOC in the BG group were higher than in the CG group ( P <0.01).","[{'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Lin', 'Affiliation': 'Department of Genral Surgery, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Jian', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecology and Obstetrics, The Second Hospital of Jilin University, Changchun 130000, China yangshulimd@163.com.'}]",Bioscience reports,['10.1042/BSR20182254']
2938,32081690,Comparison of Clinical Outcomes of CO 2  Laser-Assisted Blepharoplasty Using Two Different Methods.,"PURPOSE


Numerous methods have been developed for blepharoplasty, including carbon dioxide (CO 2 ) laser-assisted blepharoplasty. Although the superiority of CO 2  laser compared with the scalpel for blepharoplasty has been proposed, to the best of our knowledge, no study has compared the clinical outcomes of blepharoplasty with the CO 2  laser alone versus the combined use of a scalpel and CO 2  laser.
PATIENTS AND METHODS


In the present randomized clinical trial, 21 healthy patients underwent bilateral upper eyelid blepharoplasty. For each patient, an initial skin incision was made using the CO 2  laser (setting, continuous emission; ultrapulse mode; 3 W of power) on 1 side and a scalpel on the other side. The remaining blepharoplasty steps were conducted using the CO 2  laser (setting, continuous emission; 9 W of power) in both groups. The patients were evaluated on postoperative days 1, 3, 7, 14, and 30 using the postoperative repair criteria, including edema and ecchymosis. The Manchester scar scale was used to evaluate the results at 60 days after surgery.
RESULTS


Our comparison of the 2 methods showed no significant differences at 1 month after surgery using the evaluation criteria. The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
CONCLUSIONS


In upper eyelid blepharoplasty, making an initial incision with a scalpel, followed by use of a laser provides advantages similar to those found by performing the entire procedure with a CO 2  laser alone.",2020,"The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
",['21 healthy patients underwent'],"['bilateral upper eyelid blepharoplasty', 'carbon dioxide (CO 2 ) laser-assisted blepharoplasty', 'CO 2  Laser-Assisted Blepharoplasty']","['scar index', 'Manchester scar scale', 'edema and ecchymosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0585636', 'cui_str': 'Upper eyelid structure (body structure)'}, {'cui': 'C0197213', 'cui_str': 'Blepharoplasty'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0222045'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}]",21.0,0.0189338,"The scar index was not significantly different after 60 days, despite lower scores in the scalpel group.
","[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Fallahi', 'Affiliation': 'Oral Maxillofacial Surgeon, Private Practice; Dental Research Center, Research Institute of Dental Sciences and School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Seied Omid', 'Initials': 'SO', 'LastName': 'Keyhan', 'Affiliation': 'Oral Maxillofacial Surgeon, National Advance Center for Craniomaxillofacial Reconstruction, Craniomaxillofacial Research Center, Tehran University of Medical Sciences; and Regenerative Medicine and Stem Cell Research Network, Shahaid Beheshti University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Niamtu', 'Affiliation': 'Oral Maxillofacial Surgeon, Private Practice; Fellow, American Academy of Cosmetic Surgery, Chicago, IL; and Diplomat, American Board of Cosmetic Facial Surgery, Philadelphia, PA.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Alikazemi', 'Affiliation': 'Oral Maxillofacial Surgeon and Assistance Professor, Department of Oral and Maxillofacial Surgery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Raha', 'Initials': 'R', 'LastName': 'Habibagahi', 'Affiliation': 'PhD of Biomaterials, Orthodontic Research Center, School of Dentistry, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: Raha2979@yahoo.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.015']
2939,30655627,"Gender difference in the effects of cacao polyphenols on blood pressure and glucose/lipid metabolism in prediabetic subjects: a double-blinded, randomized, placebo-controlled crossover trial.",,2019,,['prediabetic subjects'],"['cacao polyphenols', 'placebo']",['blood pressure and glucose/lipid metabolism'],[],"[{'cui': 'C0006622', 'cui_str': 'Cocoa Plant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.615842,,"[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Shiina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan. tomiyama@tokyo-med.ac.jp.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Syunsuke', 'Initials': 'S', 'LastName': 'Komatsu', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Natsume', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Oba', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ohshiba', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Taketo', 'Initials': 'T', 'LastName': 'Yamaji', 'Affiliation': 'R&D Division, Meiji Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Taishiro', 'Initials': 'T', 'LastName': 'Chikamori', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Hypertension research : official journal of the Japanese Society of Hypertension,['10.1038/s41440-019-0208-8']
2940,31488307,3-Year Clinical Outcomes of the PRISON-IV Trial: Ultrathin Struts Versus Conventional Drug-Eluting Stents in Total Coronary Occlusions.,,2019,,['Total Coronary Occlusions'],['Ultrathin Struts Versus Conventional Drug-Eluting Stents'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0151814', 'cui_str': 'Coronary Occlusion'}]","[{'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]",[],,0.030361,,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Zivelonghi', 'Affiliation': ''}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': ''}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Teeuwen', 'Affiliation': ''}, {'ForeName': 'Renè J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': ''}, {'ForeName': 'Josè P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': ''}, {'ForeName': 'Paul H M J', 'Initials': 'PHMJ', 'LastName': 'Vermeersch', 'Affiliation': ''}, {'ForeName': 'Mike A R', 'Initials': 'MAR', 'LastName': 'Bosschaert', 'Affiliation': ''}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Kelder', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Maarten J', 'Initials': 'MJ', 'LastName': 'Suttorp', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.05.044']
2941,32119031,Patterns and Trends in Advance Care Planning Among Older Adults Who Received Intensive Care at the End of Life.,,2020,,['Older Adults'],[],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0186673,,"[{'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Block', 'Affiliation': 'Pulmonary, Critical Care, Allergy, and Sleep Medicine Program, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Jeon', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Pulmonary, Critical Care, Allergy, and Sleep Medicine Program, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'W John', 'Initials': 'WJ', 'LastName': 'Boscardin', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco.'}, {'ForeName': 'Alexander K', 'Initials': 'AK', 'LastName': 'Smith', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.7535']
2942,32265012,Surgical telemedicine here to stay: More support from a randomized controlled trial on postoperative surgery visits.,,2020,,[],[],[],[],[],[],,0.142445,,"[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Forbes', 'Affiliation': 'Vanderbilt University Medical Center, Department of General Surgery, 1313 21st Avenue South, Oxford House, Suite 912, Nashville, TN, 37232, USA. Electronic address: rachel.forbes@vumc.org.'}, {'ForeName': 'Carmen C', 'Initials': 'CC', 'LastName': 'Solorzano', 'Affiliation': 'Vanderbilt University Medical Center, Department of General Surgery, 1313 21st Avenue South, Oxford House, Suite 912, Nashville, TN, 37232, USA.'}, {'ForeName': 'Beatrice P', 'Initials': 'BP', 'LastName': 'Concepcion', 'Affiliation': 'Vanderbilt University Medical Center, Department of Medicine, 1313 21st Avenue South, Oxford House, Suite 912, Nashville, TN, 37232, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.03.033']
2943,32159808,Effect of Acupuncture vs Sham Procedure on Chemotherapy-Induced Peripheral Neuropathy Symptoms: A Randomized Clinical Trial.,,2020,,['Chemotherapy-Induced Peripheral Neuropathy Symptoms'],['Acupuncture'],[],"[{'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.396271,,"[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Bao', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Patil', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Iris W', 'Initials': 'IW', 'LastName': 'Zhi', 'Affiliation': 'Breast Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Qing S', 'Initials': 'QS', 'LastName': 'Li', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Piulson', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0681']
2944,32129791,Effect of a Workplace-Based Multicomponent Intervention on Hypertension Control: A Randomized Clinical Trial.,"Importance


A workplace-based intervention could be an effective approach to managing high blood pressure (BP). However, few studies to date have addressed hypertension control among the Chinese working population.
Objective


To assess the effect of a workplace-based, multicomponent intervention strategy on improving BP control.
Design, Setting, and Participants


A cluster randomized clinical trial of a hypertension management program was conducted from January 2013 to December 2014 in 60 workplaces across 20 urban regions in China. Workplaces were randomized to either the intervention group (n = 40) or control group (n = 20). Employee participants in each workplace were asked to complete a cross-sectional survey. Data analysis on an evaluable population was conducted from January 2016 to January 2017.
Interventions


The 2-year intervention included 2 components: (1) a workplace wellness program for improving employees' cardiovascular health and (2) a guidelines-oriented hypertension management protocol with a community health center intervention accompanied by monthly visits for achieving BP control over a period of 24 months.
Main Outcomes and Measures


The primary outcome was the change in BP control rate from baseline to 24 months among employees with hypertension in the intervention and control groups. The secondary outcomes were the changes in BP level and lifestyle factors by the end of the trial.
Results


Overall, 4166 participants (3178 in the intervention group and 988 in the control group) were included (mean [SD] age, 46.3 [7.6] years; 3451 men [82.8%]). Blood pressure control rate at baseline was 19.5% in the intervention group and 20.1% in the control group. After 24 months of the intervention, the BP control rate for the intervention group compared with the control group was significantly higher (66.2% vs 44.0%; odds ratio, 1.77; 95% CI, 1.58-2.00; P < .001). The intervention effect on systolic BP level was -5.8 mm Hg (95% CI, -6.8 to -4.9 mm Hg; P < .001) and on diastolic BP level was -3.6 mm Hg (95% CI, -4.4 to -2.9 mm Hg; P < .001). The BP control rate showed a gradual increment throughout the whole duration in the intervention group. Moreover, greater reduction was reported in the rates of drinking (-18.4%; 95% CI, -20.6% to -16.2%; P < .001), perceived stress (-22.9%; 95% CI, -24.8% to -21.1%; P < .001), and excessive use of salt (-32.0%; 95% CI, -33.7% to -30.4%; P < .001).
Conclusions and Relevance


This trial found that a workplace-based, multicomponent intervention appeared to be more effective than usual care, leading to measurable benefits such as lower blood pressure, improved hypertension control, and adoption of healthy lifestyle habits. The intervention can therefore be considered for large-scale use or inclusion in hypertension control programs in workplaces in China and other countries.
Trial Registration


Chinese Clinical Trial Registry No. ChiCTR-ECS-14004641.",2020,"After 24 months of the intervention, the BP control rate for the intervention group compared with the control group was significantly higher (66.2% vs 44.0%; odds ratio, 1.77; 95% CI, 1.58-2.00; P < .001).","['January 2013 to December 2014 in 60 workplaces across 20 urban regions in China', 'evaluable population was conducted from January 2016 to January 2017', 'Hypertension Control', '4166 participants (3178 in the intervention group and 988 in the control group) were included (mean [SD] age, 46.3 [7.6] years; 3451 men [82.8']","['workplace-based, multicomponent intervention strategy', 'multicomponent intervention', 'Workplace-Based Multicomponent Intervention', 'hypertension management program', ""workplace wellness program for improving employees' cardiovascular health and (2) a guidelines-oriented hypertension management protocol with a community health center intervention accompanied by monthly visits for achieving BP control""]","['changes in BP level and lifestyle factors', 'excessive use of salt', 'change in BP control rate', 'systolic BP level', 'Blood pressure control rate', 'blood pressure, improved hypertension control, and adoption of healthy lifestyle habits', 'blood pressure (BP', 'BP control rate', 'perceived stress', 'diastolic BP level', 'rates of drinking']","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",4166.0,0.0969932,"After 24 months of the intervention, the BP control rate for the intervention group compared with the control group was significantly higher (66.2% vs 44.0%; odds ratio, 1.77; 95% CI, 1.58-2.00; P < .001).","[{'ForeName': 'Zengwu', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'School of Public Health, Department of Social Medicine and Health Education, Peking University, Beijing, China.'}, {'ForeName': 'Suning', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zuo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Congyi', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Division of Prevention and Community Health, National Center for Cardiovascular Disease, The State Key Laboratory of Cardiovascular Disease, National Clinical Research Center of Cardiovascular Disease, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hao', 'Affiliation': 'School of Medicine, Department of Epidemiology, Jinan University, Guangzhou, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'School of Public Health, Department of Social Medicine and Health Education, Peking University, Beijing, China.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.6161']
2945,32129795,Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial.,"Importance


Pharmacy fill data are increasingly accessible to clinicians and researchers to evaluate longitudinal medication persistence beyond patient self-report.
Objective


To assess the agreement and accuracy of patient-reported and pharmacy fill-based medication persistence.
Design, Setting, and Participants


This post hoc analysis of the cluster randomized clinical trial ARTEMIS (Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) enrolled patients at 287 US hospitals (131 randomized to intervention and 156 to usual care) from June 5, 2015, to September 30, 2016, with 1-year follow-up and blinded adjudication of major adverse cardiovascular events. In total, 8373 patients with myocardial infarction and measurement of P2Y12 inhibitor persistence by both patient self-report and pharmacy data were included. Serum P2Y12 inhibitor drug levels were measured for 944 randomly selected patients. Data were analyzed from May 2018 to November 2019.
Interventions


Patients treated at intervention-arm hospitals received study vouchers to offset copayments at each P2Y12 inhibitor fill for 1 year after myocardial infarction.
Main Outcomes and Measures


Nonpersistence was defined as a gap of 30 days or more in P2Y12 inhibitor use (patient report) or supply (pharmacy fill) and as serum P2Y12 inhibitor levels below the lower limit of quantification (drug level). Among patients in the intervention arm, a ""criterion standard"" definition of nonpersistence was a gap of 30 days or more in P2Y12 inhibitor use by both voucher use and pharmacy fill. Major adverse cardiovascular events were defined as adjudicated death, recurrent myocardial infarction, or stroke.
Results


Of 8373 patients included in this analysis, the median age was 62 years (interquartile range, 54-70 years), 5664 were men (67.7%), and 990 (11.8%) self-reported as nonwhite race/ethnicity. One-year estimates of medication nonpersistence rates were higher using pharmacy fills (4042 patients [48.3%]) compared with patient self-report (1277 patients [15.3%]). Overall, 4185 patients (50.0%) were persistent by both pharmacy fill data and patient report, 1131 patients (13.5%) were nonpersistent by both, and 3057 patients (36.5%) were discordant. By application of the criterion standard definition, the 1-year nonpersistence rate was 1184 of 3703 patients (32.0%); 892 of 3318 patients (26.9%) in the intervention arm who self-reported persistence were found to be nonpersistent, and 303 of 1487 patients (20.4%) classified as nonpersistent by pharmacy fill data were actually persistent. Agreement between serum P2Y12 inhibitor drug levels and either patient-reported (κ = 0.11-0.23) or fill-based (κ = 0.00-0.19) persistence was poor. Patients who were nonpersistent by both pharmacy fill data and self-report had the highest 1-year major adverse cardiac event rate (18.3%; 95% CI, 16.0%-20.6%) compared with that for discordant patients (9.7%; 8.7%-10.8%) or concordantly persistent patients (8.2%; 95% CI, 7.4%-9.0%).
Conclusions and Relevance


Patient report overestimated medication persistence rates, and pharmacy fill data underestimated medication persistence rates. Patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions that improve medication-taking behavior.
Trial Registration


ClinicalTrials.gov Identifier: NCT02406677.",2020,"Patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions that improve medication-taking behavior.
","['3703 patients (32.0%); 892 of 3318 patients (26.9%) in the intervention arm who self-reported persistence were found to be nonpersistent, and 303 of 1487 patients (20.4%) classified as nonpersistent by pharmacy fill data were actually persistent', '944 randomly selected patients', '8373 patients with myocardial infarction and measurement of P2Y12 inhibitor persistence by both patient self-report and pharmacy data were included', 'After Myocardial Infarction Study) enrolled patients at 287 US hospitals (131 randomized to intervention and 156 to usual care) from June 5, 2015, to September 30, 2016, with 1-year follow-up and blinded adjudication of major adverse cardiovascular events', '8373 patients included in this analysis', 'median age was 62 years (interquartile range, 54-70 years), 5664 were men (67.7%), and 990 (11.8%) self-reported as nonwhite race/ethnicity']",['Interventions\n\n\nPatients treated at intervention-arm hospitals received study vouchers to offset copayments at each P2Y12 inhibitor fill'],"['Serum P2Y12 inhibitor drug levels', 'highest 1-year major adverse cardiac event rate', 'adjudicated death, recurrent myocardial infarction, or stroke', 'Major adverse cardiovascular events', 'gap of 30 days or more in P2Y12 inhibitor use (patient report) or supply (pharmacy fill) and as serum P2Y12 inhibitor levels below the lower limit of quantification (drug level', '1-year nonpersistence rate', 'medication nonpersistence rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517916', 'cui_str': '990 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0428212', 'cui_str': 'Finding of drug level (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0233419', 'cui_str': 'Nonpersistence (finding)'}]",8373.0,0.0680495,"Patients who are nonpersistent by both methods have the worst clinical outcomes and should be prioritized for interventions that improve medication-taking behavior.
","[{'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Fanaroff', 'Affiliation': 'Leonard Davis Institute of Health Economics, Penn Cardiovascular Outcomes, Quality and Evaluative Research Center, Cardiovascular Medicine Division, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'University of Missouri-Kansas City School of Medicine, Kansas City.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Fonseca', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Naeem D', 'Initials': 'ND', 'LastName': 'Khan', 'Affiliation': 'AstraZeneca, Wilmington, Delaware.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Division of Cardiology, Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0125']
2946,31402735,Phenotypic overlap in neonatal respiratory morbidity following preterm premature rupture of membranes versus spontaneous preterm labor.,"Background:  Bronchopulmonary dysplasia (BPD), a major source of morbidity in premature neonates, has been associated with intrauterine infection and preterm birth. Both preterm premature rupture of membranes (PPROM) and spontaneous preterm labor (sPTL) are linked with intrauterine inflammation. Whether PPROM and sPTL, as two phenotypic categories of preterm birth, are associated with exposure to different degrees and durations of inflammation that might impact fetal lung development is unknown. PPROM may be associated with longer latency until delivery, which is beneficial for neonatal mortality, but may impart greater injury risk to the developing fetal lungs. It is unknown if PPROM is associated with a greater risk of adverse neonatal respiratory outcomes than sPTL.  Objective:  The objective of this study was to determine if PPROM imparts a differentially greater risk for neonatal BPD than sPTL. A secondary objective was to determine if PPROM was associated with a greater risk of adverse neonatal respiratory outcomes other than BPD and whether gestational latency following PPROM or sPTL diagnosis constitutes a risk factor for fetal lung injury.  Study design:  We conducted a retrospective secondary analysis of a large cohort of women at risk for spontaneous preterm birth, who were originally enrolled in a randomized controlled trial of magnesium sulfate versus placebo examining neuroprotection. For our study, we included women with a singleton pregnancy complicated by PPROM or sPTL and delivery between 24 and 34 weeks gestational age. Cases with multiple gestation, congenital anomalies, maternal seropositivity for human immunodeficiency virus, or hypertensive diseases of pregnancy (including preeclampsia) were excluded. The primary outcome was BPD. Secondary outcomes were respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), requirement for mechanical ventilation, pneumonia, neonatal sepsis, fetal or neonatal death, and a composite of adverse neonatal respiratory outcomes including (BPD, pneumonia, RDS, and TTN). Statistical analyses included chi-square, Student's  t -test and logistic and multiple regression.  Results:  A total of 1729 women were included in this analysis including 1554 with PPROM and 175 with sPTL. Women in the PPROM group were more likely to be older, not of Hispanic race, married, more educated, have smoked during pregnancy and have a greater body mass index. The BPD rate was not significantly different following PPROM versus sPTL. Neonates in the PPROM group experienced a lower rate of pneumonia ( p  = .001), neonatal sepsis ( p  = .009) and patent ductus arterious (PDA) requiring either medical or surgical therapy ( p  < .001) than neonates in the sPTL group. Chorioamnionitis was more common in the PPROM group ( p  = .008) than the sPTL group. After multivariable logistic regression with BPD or composite of adverse neonatal respiratory outcomes as the dependent outcomes, and controlling for gestational age at delivery, maternal smoking history, duration of mechanical ventilation and RDS, there was no significant difference between PPROM and sPTL.  Conclusions:  BPD rates were not significantly different in neonates born to women following PPROM versus sPTL. However, PPROM was associated with lower rates of pneumonia, neonatal sepsis, and PDA requiring therapy in the univariate analysis, but not the multivariate analysis. Neonatal respiratory outcomes may have a similar phenotypic overlap regardless of whether preterm birth follows PPROM or sPTL.",2019,Chorioamnionitis was more common in the PPROM group ( p  = .008) than the sPTL group.,"['large cohort of women at risk for spontaneous preterm birth', 'A total of 1729 women were included in this analysis including 1554 with PPROM and 175 with sPTL', 'Cases with multiple gestation, congenital anomalies, maternal seropositivity for human immunodeficiency virus, or hypertensive diseases of pregnancy (including preeclampsia', 'women with a singleton pregnancy complicated by PPROM or sPTL and delivery between 24 and 34 weeks gestational age', 'premature neonates']",['magnesium sulfate versus placebo'],"['BPD', 'patent ductus arterious (PDA) requiring either medical or surgical therapy', 'rates of pneumonia, neonatal sepsis, and PDA requiring therapy', 'rate of pneumonia', 'gestational age at delivery, maternal smoking history, duration of mechanical ventilation and RDS', 'BPD rate', 'BPD rates', 'neonatal sepsis', 'respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN), requirement for mechanical ventilation, pneumonia, neonatal sepsis, fetal or neonatal death, and a composite of adverse neonatal respiratory outcomes including (BPD, pneumonia, RDS, and TTN']","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0729264', 'cui_str': 'PPROM'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0032989', 'cui_str': 'Multiple Pregnancy'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030650', 'cui_str': 'Patent'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C3665339', 'cui_str': 'Bacterial sepsis of newborn (disorder)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0158940', 'cui_str': 'Transient Tachypnea of the Newborn'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",1729.0,0.232346,Chorioamnionitis was more common in the PPROM group ( p  = .008) than the sPTL group.,"[{'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Kachikis', 'Affiliation': 'a Department of Obstetrics and Gynecology, University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Christie L', 'Initials': 'CL', 'LastName': 'Walker', 'Affiliation': 'a Department of Obstetrics and Gynecology, University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'McAdams', 'Affiliation': 'b Department of Pediatrics, University of Wisconsin , Madison , WI , USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': 'c Department of Obstetrics and Gynecology, Columbia University , New York , NY , USA.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Adams Waldorf', 'Affiliation': 'a Department of Obstetrics and Gynecology, University of Washington , Seattle , WA , USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1651280']
2947,32102033,Trabeculectomy With Extended Subscleral Tunnel Versus Conventional Trabeculectomy in the Management of POAG: A 1-Year Randomized-controlled Trial.,"PRECIS


This clinical trial compares a modified trabeculectomy technique [extended subscleral tunnel (ESST)] with conventional trabeculectomy [subscleral trabeculectomy (SST)] in terms of success rate and bleb morphology. ESST showed comparable results, with lower incidence of bleb-related complications and need for postoperative antiglaucoma medications.
BACKGROUND


To evaluate the outcome of modified trabeculectomy with extended subscleral tunnel ""ESST"" versus conventional subscleral trabeculectomy ""SST"" in the management of uncontrolled primary open-angle glaucoma.
PARTICIPANTS AND METHODS


This is a randomized clinical trial of 40 eyes (40 patients) divided into 2 equal groups. In the first group, a conventional SST with adjuvant 0.3% mitomycin-C was performed. In the second group, the ESST group, an additional 1.00 mm wide longitudinal scleral groove was dissected and excised in the center of the deep scleral bed extending 1.00 mm beyond the posterior margin of the flap. Patients were examined on days 1, 7, 14, 30, 90, 180, and at 1 year, with a special focus on intraocular pressure and bleb morphology. Postoperative ultrasound biomicroscopy was performed to evaluate the surgical area.
RESULTS


Both groups showed a significant reduction in intraocular pressure, with the ESST group showing significantly lower values on days 7, 14, 30, 90, and 180 (P=0.001, 0.004, 0.026, 0.001, and 0.048), but no significant differences on day 1 and at 1 year (P=0.06 and 0.07). The need for postoperative antiglaucoma medications was significantly lower in the ESST group (P=0.043). Visually significant cataract and bleb related complications were more in the SST group (P=0.044 and <0.001). Significantly more eyes in the ESST group showed normal bleb vascularity and wider extent.
CONCLUSIONS


ESST offers a guarded posterior flow with a success rate comparable to that of conventional SST. ESST could minimize bleb-related complications and bleb-dysesthesia with better long-term bleb morphology and vascularity. It could also minimize the need for further adjuvant postoperative antiglaucoma medications.",2020,"Both groups showed significant reduction in IOP with the ESST group showing significantly lower values on days 7,14,30,90 and 180 (P=0.001,0.004,0.026, 0.001,0.048) but no significant differences on day 1 and at 1 year (P=0.06,0.07).",['40 eyes (40 patients) divided into 2 equal groups'],"['Postoperative ultrasound biomicroscopy', 'conventional trabeculectomy (SST', 'modified trabeculectomy technique (ESST', 'modified trabeculectomy with extended subscleral tunnel ""ESST"" versus conventional subscleral trabeculectomy ""SST', 'conventional SST with adjuvant 0.3% mitomycin-C', 'Trabeculectomy with Extended Subscleral Tunnel versus Conventional Trabeculectomy', 'ESST']","['postoperative anti-glaucoma medications', 'Visually significant cataract and bleb related complications', 'normal bleb vascularity and wider extent', 'IOP', 'intraocular pressure (IOP) and bleb morphology']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1301497', 'cui_str': 'Ultrasound Biomicroscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",,0.0560337,"Both groups showed significant reduction in IOP with the ESST group showing significantly lower values on days 7,14,30,90 and 180 (P=0.001,0.004,0.026, 0.001,0.048) but no significant differences on day 1 and at 1 year (P=0.06,0.07).","[{'ForeName': 'Riham S H M', 'Initials': 'RSHM', 'LastName': 'Allam', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Raafat', 'Affiliation': ''}, {'ForeName': 'Rehab M', 'Initials': 'RM', 'LastName': 'Abdel-Hamid', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001480']
2948,30734696,Effect Modification by Baseline Mortality in the MORDOR Azithromycin Trial.,"We examined whether baseline mortality risk, as a function of child age and site, modified the azithromycin mortality-reduction effect in the  Macrolide Oraux pour Réduire les Décès avec un Oeil sur la Résistance  (MORDOR) clinical trial. We used the Cox proportional hazards model with an interaction term. Three models were examined representing three sources for the baseline-risk covariate: two using sources external to MORDOR and the third leveraging data within MORDOR. All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality. Etiological and programmatic implications of these findings are discussed.",2020,"All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality.",[],[],['baseline mortality'],[],[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0416482,"All three models provided moderate evidence for the effect becoming stronger with increasing baseline mortality ( P  = 0.02, 0.02, and 0.07, respectively) at the rate of approximately 6-12% additional mortality reduction per doubling of baseline mortality.","[{'ForeName': 'Assaf P', 'Initials': 'AP', 'LastName': 'Oron', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Burstein', 'Affiliation': 'Institute for Health Metrics and Evaluation, University of Washington, Seattle, Washington.'}, {'ForeName': 'Laina D', 'Initials': 'LD', 'LastName': 'Mercer', 'Affiliation': 'Institute for Disease Modeling, Bellevue, Washington.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center, Niamey, Niger.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Kalua', 'Affiliation': 'Blantyre Institute for Community Outreach and the College of Medicine, University of Malawi, Blantyre.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'The Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'The London School of Tropical Hygiene and Medicine, London, United Kingdom.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.18-1004']
2949,31866099,Reduction in mouse allergen exposure is associated with greater lung function growth.,"BACKGROUND


Current childhood asthma therapies have little effect on lung function trajectory.
OBJECTIVE


We sought to determine whether mouse allergen exposure reduction is associated with lung function growth in mouse-sensitized/exposed asthmatic children.
METHODS


Three hundred fifty mouse-sensitized/exposed asthmatic children (5-17 years old) were enrolled in a 1-year randomized trial of integrated pest management plus education versus education alone. Prebronchodilator/postbronchodilator spirometry was performed at baseline and 6 and 12 months, and bedroom floor mouse allergen levels were measured every 3 months. Mouse allergen reduction was defined as a 75% or greater decrease in mouse allergen levels from baseline. Treatment groups were combined for analyses because there were no differences in outcomes between groups. Changes in lung function over time were modeled, adjusting for age, sex, race, atopy, group, and bronchodilator reversibility and including an interaction term (allergen reduction*time).
RESULTS


The study population was predominantly black (79.4%) and low income (66.3% [<$30,000]). At baseline, the median mouse allergen level was 5.7 μg/g (interquartile range, 1.5-22.8 μg/g), and the mean (SD) prebronchodilator FEV 1 /forced vital capacity ratio was 80.2% (9.0%). Ninety-two (26.3%) participants had 75% or greater reduction in mouse allergen levels. For a 10-year-old black boy, 75% or greater allergen reduction was associated with an increase in prebronchodilator FEV 1  of 238 mL/y (95% CI, 177-299 mL/y), whereas less than 75% allergen reduction was associated with an increase in prebronchodilator FEV 1  of 131 mL/y (95% CI, 97-166 mL/y). Estimated differences in prebronchodilator and postbronchodilator FEV 1  growth were as follows: 107 mL/y (95% CI, 37-177 mL/y; P int  = .003) and 48 mL/y (95% CI, -17 to 113 mL/y; P int  = .15), respectively. Estimated differences in prebronchodilator and postbronchodilator forced expiratory flow at 25% to 75% of vital capacity growth were as follows: 182 mL/y (95% CI, 61-304 mL/y; P int  = .003) and 181 mL/y (95% CI, 48-314 mL/y; P int  = .008), respectively.
CONCLUSION


Mouse allergen reduction is associated with greater increases in prebronchodilator FEV 1  and prebronchodilator/postbronchodilator forced expiratory flow at 25% to 75% of vital capacity over 1 year among sensitized/exposed asthmatic children.",2020,Ninety-two (26.3%) participants had 75% or greater reduction in mouse allergen levels.,"['Three hundred fifty mouse-sensitized/exposed asthmatic children (5-17 years old', 'The study population was predominantly black (79.4%) and low income (66.3% [<$30,000', 'mouse-sensitized/exposed asthmatic children']","['Prebronchodilator/postbronchodilator spirometry', 'integrated pest management plus education versus education alone']","['median mouse allergen level', 'prebronchodilator FEV', 'prebronchodilator and postbronchodilator forced expiratory flow', 'mouse allergen levels', 'prebronchodilator FEV 1  and prebronchodilator/postbronchodilator forced expiratory flow', 'mean (SD) prebronchodilator FEV 1 /forced vital capacity ratio']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0031249', 'cui_str': 'Pest Management'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",350.0,0.180617,Ninety-two (26.3%) participants had 75% or greater reduction in mouse allergen levels.,"[{'ForeName': 'Torie', 'Initials': 'T', 'LastName': 'Grant', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard University Medical School, Boston, Mass.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Perzanowski', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Balcer-Whaley', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Curtin-Brosnan', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Amparito', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard University Medical School, Boston, Mass.""}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Divjan', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Bollinger', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Divisions of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Matsui', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md; Departments of Population Health and Pediatrics, Dell Medical School at University of Texas at Austin, Austin, Tex. Electronic address: elizabeth.matsui@austin.utexas.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.043']
2950,32186456,Re: Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,,2020,,['Overactive Bladder Symptoms in Men'],['Combined Behavioral and Drug Therapy'],[],"[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],,0.16352,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001003.01']
2951,32061731,Efficacy and Safety of Intensive Blood Pressure Therapy Using Restricted Mean Survival Time-Insights from the SPRINT Trial.,,2020,,[],['Intensive Blood Pressure Therapy'],[],[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0489886,,"[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Krishnaswami', 'Affiliation': 'Division of Cardiology, Kaiser Permanente San Jose Medical Center, San Jose, Calif; Department of Epidemiology and Biostatistics, University of California, San Francisco. Electronic address: ashok.krishnaswami@kp.org.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': 'Division of Cardiology, Washington University, St. Louis, Mo.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.050']
2952,31743424,Estimating individualized treatment regimes from crossover designs.,"The field of precision medicine aims to tailor treatment based on patient-specific factors in a reproducible way. To this end, estimating an optimal individualized treatment regime (ITR) that recommends treatment decisions based on patient characteristics to maximize the mean of a prespecified outcome is of particular interest. Several methods have been proposed for estimating an optimal ITR from clinical trial data in the parallel group setting where each subject is randomized to a single intervention. However, little work has been done in the area of estimating the optimal ITR from crossover study designs. Such designs naturally lend themselves to precision medicine since they allow for observing the response to multiple treatments for each patient. In this paper, we introduce a method for estimating the optimal ITR using data from a 2 × 2 crossover study with or without carryover effects. The proposed method is similar to policy search methods such as outcome weighted learning; however, we take advantage of the crossover design by using the difference in responses under each treatment as the observed reward. We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.",2020,"We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.",[],[],[],[],[],[],,0.0469592,"We establish Fisher and global consistency, present numerical experiments, and analyze data from a feeding trial to demonstrate the improved performance of the proposed method compared to standard methods for a parallel study design.","[{'ForeName': 'Crystal T', 'Initials': 'CT', 'LastName': 'Nguyen', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Luckett', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Kahkoska', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Shearrer', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Spruijt-Metz', 'Affiliation': 'Center of Economic and Social Research, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Jaimie N', 'Initials': 'JN', 'LastName': 'Davis', 'Affiliation': 'Department of Nutrition, University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Kosorok', 'Affiliation': 'Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina.'}]",Biometrics,['10.1111/biom.13186']
2953,31230384,Does ex vivo perfusion lead to more or less intimal thickening in the first-year post-heart transplantation?,"BACKGROUND


The Organ Care System (OCS), an ex vivo heart perfusion platform, represents an alternative to the current standard of cold organ storage that sustains the donor heart in a near-physiologic state. Previous reports showed that this system had significantly shortened the cold ischemic time from standard cold storage (CS). However, the effect of reduced ischemic injury against the coronary vascular bed has not been examined by intravascular ultrasound (IVUS).
METHODS


Between August 2011 and February 2013, heart transplant (HTx) candidates enrolled in the PROCEED 2 trial were randomized to either CS or OCS. IVUS was performed at 4-6 weeks (baseline) and repeated 1 year after transplantation. The change in maximal intimal thickness (MIT) and other clinical outcomes were examined.
RESULTS


Thirty-nine patients were randomized and underwent HTx by OCS (n=16) or CS (n=18). Of these, 18 patients (OCS: n=5, CS: n=13) with paired IVUS were examined. There were no significant differences in the change of MIT and other clinical outcomes between the groups.
CONCLUSION


The incidence of cardiac allograft vasculopathy in donor hearts preserved with the OCS versus CS was similar. These results suggest that this ex vivo allograft perfusion system is a promising and valid platform for donor heart transportation.",2019,"There were no significant differences in the change of MIT and other clinical outcomes between the groups.
","['Between August 2011 and February 2013', 'Thirty-nine patients were randomized and underwent HTx by OCS (n=16) or CS (n=18', '18 patients (OCS: n=5, CS: n=13) with paired IVUS were examined']",['CS or OCS'],"['change of MIT', 'maximal intimal thickness (MIT', 'cold ischemic time', 'cardiac allograft vasculopathy']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1563922', 'cui_str': 'Cold Ischemic Time'}, {'cui': 'C0564471', 'cui_str': 'Allograft heart (substance)'}]",39.0,0.0439206,"There were no significant differences in the change of MIT and other clinical outcomes between the groups.
","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Azarbal', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cheng', 'Affiliation': 'Cardiothoracic Surgery, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Fardad', 'Initials': 'F', 'LastName': 'Esmailian', 'Affiliation': 'Cardiothoracic Surgery, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Jignesh', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kittleson', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Czer', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Thottam', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Levine', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Dimbil', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Olymbios', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Toshihisa', 'Initials': 'T', 'LastName': 'Anzai', 'Affiliation': 'Department of Cardiovascular Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Hamilton', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}, {'ForeName': 'Tamer', 'Initials': 'T', 'LastName': 'Khayal', 'Affiliation': 'TransMedics Inc., Andover, Massachusetts.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Kobashigawa', 'Affiliation': 'Department of Cardiology, Cedars-Sinai Smidt Heart Institute, Los Angeles, California.'}]",Clinical transplantation,['10.1111/ctr.13648']
2954,32067629,"Impact of Biannual Azithromycin on Anemia in Preschool Children in Kilosa District, Tanzania: A Cluster-Randomized Clinical Trial.","A cluster-randomized clinical trial showed that biannual single-dose azithromycin reduced mortality in preschool children; we sought to determine the effect on anemia. A simple random sample of 30 communities from Kilosa district, Tanzania, were themselves randomized to receive either 6-monthly treatment of children aged 1-59 months with single-dose azithromycin or placebo. From each community, 40 preschool children were randomly selected at baseline, 12 months, and 24 months. At surveys, the children underwent hemoglobin testing; WHO definitions for anemia were applied. After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months. In each of the cross-sectional surveys, anemia prevalence was associated with younger age; the odds of being anemic was highest in those aged < 12 months. There was also a general decrease in the prevalence of anemia during the study. Although azithromycin was not shown to affect anemia, significantly, the study highlights burden of anemia in rural, African communities.",2020,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","['Preschool Children in Kilosa District, Tanzania', '40 preschool children', '30 communities from Kilosa district, Tanzania', 'preschool children']","['azithromycin or placebo', 'Biannual Azithromycin', 'azithromycin']","['prevalence of anemia', 'anemia prevalence']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",40.0,0.144766,"After adjusting for community clustering, the prevalence of anemia was not significantly different by treatment assignment at baseline, 12 months, and 24 months.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0500']
2955,31693078,Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial.,"Importance


Women experience worse ischemic and bleeding outcomes after percutaneous coronary intervention (PCI).
Objectives


To assess the association of sex with patient outcomes at 2 years after contemporary PCI and with the efficacy and safety of 2 antiplatelet strategies.
Design, Setting, and Participants


This study is a prespecified subgroup analysis of the investigator-initiated, prospective, randomized GLOBAL LEADERS study evaluating 2 strategies of antiplatelet therapy after PCI in an unselected population including 130 secondary/tertiary care hospitals in different countries. The main study enrolled 15 991 unselected patients undergoing PCI between July 2013 and November 2015. Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure. Data were analyzed between January 1, 2019, and March 31, 2019.
Interventions


Eligible patients were randomized to either the experimental or reference antiplatelet strategy. Experimental strategy consisted of 1 month of dual antiplatelet therapy (DAPT) followed by 23 months of ticagrelor monotherapy, while the reference strategy comprised of 12 months of DAPT followed by 12 months of aspirin monotherapy.
Main Outcomes and Measures


The primary efficacy end point was the composite of all-cause mortality and new Q-wave myocardial infarction at 2 years. The secondary safety end point was Bleeding Academic Research Consortium type 3 or 5 bleeding.
Results


Of the 15 968 patients included in this study, 3714 (23.3%) were women. The risk of the primary end point at 2 years was similar between women and men (adjusted hazard ratio [HR], 1.00; 95% CI, 0.83-1.20). Compared with men, women had higher risk of Bleeding Academic Research Consortium type 3 or 5 bleeding (adjusted HR, 1.32; 95% CI, 1.04-1.67) and hemorrhagic stroke at 2 years (adjusted HR, 4.76; 95% CI, 1.92-11.81). At 2 years, there was no between-sex difference in the efficacy and safety of the 2 antiplatelet strategies. At 1 year, compared with DAPT, ticagrelor monotherapy was associated with a lower risk of bleeding in men (HR, 0.72; 95% CI, 0.53-0.98) but not in women (HR, 1.23; 95% CI, 0.80-1.89; P for interaction = .045).
Conclusions and Relevance


Compared with men, women experienced a higher risk of bleeding and hemorrhagic stroke after PCI. The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years.
Trial Registration


ClinicalTrials.gov identifier: NCT01813435.",2020,"The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years.
","['Patients Undergoing Percutaneous Coronary Intervention', 'unselected population including 130 secondary/tertiary care hospitals in different countries', '15\u202f968 patients included in this study, 3714 (23.3%) were women', '991 unselected patients undergoing PCI between July 2013 and November 2015', 'Patients had an outpatient clinic visit at 30 days and 3, 6, 12, 18, and 24 months after the index procedure']","['percutaneous coronary intervention (PCI', 'DAPT, ticagrelor monotherapy', 'ticagrelor monotherapy', 'dual antiplatelet therapy (DAPT', 'aspirin monotherapy']","['composite of all-cause mortality and new Q-wave myocardial infarction', 'ischemic and bleeding outcomes', 'risk of bleeding and hemorrhagic stroke', 'efficacy and safety', 'lower risk of bleeding', 'Bleeding Academic Research Consortium type 3 or 5 bleeding', 'death and Q-wave myocardial infarction', 'hemorrhagic stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",130.0,0.219105,"The effect of 2 antiplatelet strategies on death and Q-wave myocardial infarction following PCI did not differ between the sexes at 2 years.
","[{'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kerkmeijer', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chun-Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Komiyama', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Tiziano', 'Initials': 'T', 'LastName': 'Moccetti', 'Affiliation': 'Department of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth and Christchurch National Health Services Trust, Bournemouth, England.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Division of Interventional Cardiology, Cardio-Thoracic-Vascular Department, San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Maillard', 'Affiliation': 'GCS ES Axium Rambot, Aix en Provence, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Barlis', 'Affiliation': ""St Vincent's and Northern Hospitals, Melbourne Medical School, The University of Melbourne, Victoria, Australia.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wykrzykowska', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'East Lancashire Hospitals National Health Services Trust, Blackburn, Lancashire, England.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials; Hôpital Bichat, AP-HP; Université Paris-Diderot; INSERM U-1148; Paris, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, England.'}]",JAMA cardiology,['10.1001/jamacardio.2019.4296']
2956,32123315,Phase 2 trial of monoamine oxidase inhibitor phenelzine in biochemical recurrent prostate cancer.,"PURPOSE


Monoamine oxidase A (MAOA) influences prostate cancer growth and metastasis in pre-clinical models. We examined effects of phenelzine (a monoamine oxidase inhibitor) in patients with biochemical recurrent castrate-sensitive prostate cancer.
MATERIALS AND METHODS


An open-label single arm clinical trial enrolled subjects with biochemical recurrent prostate cancer defined by PSA ≥ 0.4 ng/ml (post prostatectomy) or PSA ≥ 2 ng/ml above nadir (post-radiation therapy); no evidence of metastasis on imaging; and normal androgen levels. Subjects received phenelzine 30 mg orally twice daily. Mood symptoms were assessed with the hospital anxiety depression score (HADS) questionnaire. The primary endpoint was the proportion of patients who achieved a PSA decline of ≥50% from baseline.
RESULTS


Characteristics of the 20 eligible patients enrolled included: mean ± SD age 66.9 ± 4.8 years and PSA 4.7 ± 5.8 ng/dl. Maximal PSA declines ≥30% and ≥50% were observed in 25% (n = 5/20) and 10% (n = 2/20) of subjects, respectively. At 12 weeks, 17 subjects remained on treatment with PSA declines ≥30% and ≥50% of 24% (n = 4/17) and 6% (n = 1/17), respectively. Common toxicities observed included dizziness (grade 1 = 45%, grade 2 = 35%), hypertension (grade ≥ 2 = 30%), and edema (grade 1 = 25%, grade 2 = 10%). There was one episode of grade 4 hypertension (cycle 4) and two episodes of grade 3 syncope (cycle 12 and cycle 14) requiring treatment discontinuation. HADS questionnaires demonstrated a significant decrease in anxiety with no change in depressive symptoms on treatment.
CONCLUSIONS


Phenelzine demonstrated efficacy in patients with biochemical recurrent castrate-sensitive prostate cancer. Most treatment-related toxicities were mild, but rare significant and reversible cardiovascular toxicities were observed. Therapies directed at MAOA may represent a new avenue for treatment in patients with recurrent prostate cancer.",2020,"HADS questionnaires demonstrated a significant decrease in anxiety with no change in depressive symptoms on treatment.
","['subjects with biochemical recurrent prostate cancer defined by PSA\u2009≥\u20090.4\u2009ng/ml (post prostatectomy) or PSA\u2009≥\u20092\u2009ng/ml above nadir (post-radiation therapy); no evidence of metastasis on imaging; and normal androgen levels', 'biochemical recurrent prostate cancer', 'patients with recurrent prostate cancer', 'patients with biochemical recurrent castrate-sensitive prostate cancer', '20 eligible patients enrolled included: mean\u2009±\u2009SD age 66.9\u2009±\u20094.8 years and PSA 4.7\u2009±\u20095.8\u2009ng/dl']","['Monoamine oxidase A (MAOA', 'phenelzine 30\u2009mg orally twice daily', 'phenelzine (a monoamine oxidase inhibitor', 'Phenelzine', 'monoamine oxidase inhibitor phenelzine']","['Mood symptoms', 'anxiety', 'dizziness', 'hypertension', 'Maximal PSA declines', 'proportion of patients who achieved a PSA decline', 'reversible cardiovascular toxicities', 'toxicities', 'depressive symptoms', 'hospital anxiety depression score (HADS) questionnaire']","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0445177', 'cui_str': 'Post-radiation (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332125', 'cui_str': 'No evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}]","[{'cui': 'C0026455', 'cui_str': 'MAO-A'}, {'cui': 'C0031392', 'cui_str': 'Phenelzine'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4521320', 'cui_str': 'Monoamine oxidase inhibitor (disposition)'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",20.0,0.0681233,"HADS questionnaires demonstrated a significant decrease in anxiety with no change in depressive symptoms on treatment.
","[{'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Gross', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA. mitchell.gross@usc.edu.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Agus', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tanya B', 'Initials': 'TB', 'LastName': 'Dorff', 'Affiliation': 'Department of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jacek K', 'Initials': 'JK', 'LastName': 'Pinski', 'Affiliation': 'Department of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Department of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castellanos', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Gilmore', 'Affiliation': 'Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Shih', 'Affiliation': 'Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. jcshih@usc.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0211-9']
2957,32112353,Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation.,"Allogeneic hematopoietic cell transplantation (alloHCT) is a life-saving technology that can cure otherwise incurable diseases, but imposes significant physiologic stress upon recipients. This stress leads to short-term toxicity and mid- to long-term physical function impairment in some recipients. Exercise interventions have demonstrated preliminary efficacy in preserving physical function in HCT recipients, but the role of these interventions prior to HCT (prehabilitative) is less known. We tested a 5- to 12-week, prehabilitative higher intensity home-based aerobic exercise intervention in a randomized study of alloHCT candidates. Of 113 patients screened, 34 were randomized to control or intervention groups, 16 underwent pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention 6-min walk distance (6MWD) testing. No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention. We conclude that the design of our prehabilitative intervention was not feasible in this pilot randomized study, and make recommendations regarding the design of future exercise intervention studies in alloHCT.",2020,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","['113 patients screened, 34 were randomized to control or intervention groups, 16 underwent']","['home-based exercise prescription before allogeneic hematopoietic cell transplantation', 'prehabilitative higher intensity home-based aerobic exercise intervention', 'pre- and post-intervention peak oxygen consumption (VO 2peak ) testing, and 12 underwent pre- and post-intervention', 'Allogeneic hematopoietic cell transplantation (alloHCT', 'Exercise interventions']","['6-min walk distance (6MWD', 'VO 2peak  or 6MWD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",34.0,0.0488959,"No significant differences in VO 2peak  or 6MWD were seen pre- to post-intervention between intervention and control groups, but final numbers of evaluable participants in each group were too small to draw inferences regarding the efficacy of the intervention.","[{'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. wawood@med.unc.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weaver', 'Affiliation': 'Department of Mathematics and Statistics, Elon University, Elon, NC, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Smith-Ryan', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Battaglini', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05369-1']
2958,32105616,Evaluation of Success of Transport Disc Distraction Osteogenesis and Costochondral Graft for Ramus Condyle Unit Reconstruction in Pediatric Temporomandibular Joint Ankylosis.,"PURPOSE


The costochondral graft (CCG) is considered the reference standard for pediatric temporomandibular joint reconstruction. It has the disadvantages of unpredictable growth, donor site morbidity, and the need for intermaxillary fixation. It has been reported that transport disk distraction osteogenesis (TDDO) can result in the formation of a neocondyle and disc. We performed a randomized trial to measure and compare clinically relevant outcomes of ramus-condyle unit (RCU) reconstruction using CCG and TDDO for pediatric temporomandibular joint ankylosis (TMJA).
MATERIALS AND METHODS


In the present randomized controlled trial (block randomization with a variable block size), pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16 years who had presented to our unit from December 2015 to June 2017 were enrolled. Instead of temporalis myofascial flap interposition, a buccal fat pad was used to fill the gap created by osteoarthrectomy. The primary outcome parameter was mouth opening. A mouth opening of at least 25 mm at the median follow-up point was considered success. The secondary outcome parameters were occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation. Data were analyzed using the independent t test and rank sum test.
RESULTS


A total of 24 patients were enrolled in the CCG and TDDO groups (n = 12 in each group). Trauma (40.9%) was the most common etiology with a slight male preponderance (59.09%). The mean age was 10.32 ± 2.85 years. The average distraction achieved in the TDDO group was 10.42 mm. The median follow-up duration was 31.5 months (range, 24 to 39 months). The mean preoperative maximal incisal opening had improved from 8.5 ± 4.1 and 9.5 ± 7.1 mm in the CCG and TDDO groups preoperatively to 35.7 ± 2.7 and 34.4 ± 8.9 mm, respectively, at the median follow-up point (P < .005). RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed statistically non-significant differences. No reankylosis or open bite was found. The 3-hour delayed gadolinium-enhanced magnetic resonance imaging scan showed successful neo-disc formation.
CONCLUSIONS


Similar success can be achieved in RCU reconstruction using either CCG or TDDO for pediatric TMJA. Both techniques have some advantages and disadvantages. RCU reconstruction using CCG or TDDO results in formation of a neocondyle, maintenance of occlusion, and correction of facial asymmetry.",2020,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","['24 patients were enrolled in the CCG and TDDO groups (n\xa0=\xa012 in each group', 'The mean age was 10.32\xa0±\xa02.85\xa0years', 'Pediatric Temporomandibular Joint Ankylosis', 'pediatric patients with unilateral, nonrecurrent TMJA aged 3 to 16\xa0years who had presented to our unit from December 2015 to June 2017 were enrolled']","['transport disk distraction osteogenesis', 'Transport Disc Distraction Osteogenesis and Costochondral Graft', 'ramus-condyle unit (RCU) reconstruction using CCG and TDDO', 'temporalis myofascial flap interposition', 'gadolinium-enhanced magnetic resonance imaging scan']","['mouth opening', 'average distraction', 'mean preoperative maximal incisal opening', 'occlusion, laterotrusion, protrusion, reankylosis, neocondyle, chin deviation, facial asymmetry, midline shift, and neo-disc formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2931375', 'cui_str': 'Temporomandibular ankylosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0524975', 'cui_str': 'Osteogenesis, Distraction'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0039487', 'cui_str': 'Temporal Muscle'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}]","[{'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C4040028', 'cui_str': 'Incisal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0333056', 'cui_str': 'Protrusion (morphologic abnormality)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C1306710', 'cui_str': 'Facial asymmetry (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",24.0,0.0728373,"RCU reconstruction with both modalities resulted in improvement in all the parameters; however, the intergroup comparison showed nonstatistically significant differences.","[{'ForeName': 'Kamalpreet', 'Initials': 'K', 'LastName': 'Kaur', 'Affiliation': 'Research Scientist, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu Seith', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Assistant Professor, Division of Oral and Maxillofacial Surgery, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravinder M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.029']
2959,31740981,Prospective trial on telemonitoring of geriatric cancer patients using handheld devices.,"PURPOSE AND OBJECTIVE


Randomized trials indicate that electronic or app-based assessment of patient-reported outcomes may improve outcomes in cancer patients. To analyze if an app-based follow-up would be accepted by elderly cancer patients, we conducted a single-center prospective feasibility study (NCT03196050).
MATERIALS AND METHODS


Cancer patients (≥60 years) without concurrent uncontrolled severe medical conditions and a Karnofsky performance status (KPS) ≥70 were eligible if they were able to use the smartphone app. The primary endpoint was compliance over 1 year, calculated as patient-specific and study date-specific response rate to questions sent as push notifications; in this interim analysis, we report on 4‑month data. Secondary outcomes included a comparison of a subjective health status item (SPHS) with the physician-rated KPS.
RESULTS


Out of 225 patients screened, 54 patients agreed to participate and 29 activated the app and participated in the study. The mean age was 66 years (61-78). The individual compliance rate averaged at 58.3% (standard deviation SD = 35%). Daily compliance was 53.3% on average (SD = 10.8%) and declined over time. The average percentage of patients who sent answers at least weekly was 75.0% (SD = 14.8%) and declined from 100% in week 1 to 53.8% in week 17 post-enrollment. Secondary outcomes indicated that questionnaires such as the EORTC-QLQ-C30 are accepted via app and that there is a significant moderate correlation between the SPHS and KPS scores (r = 0.566; p < 0.001).
CONCLUSION


Our data indicate that an app-based follow-up incorporating EORTC questionnaires might be possible in highly selected elderly cancer patients with modest compliance rates. Further trials should aim at an increased participation rate.",2020,The average percentage of patients who sent answers at least weekly was 75.0% (SD = 14.8%) and declined from 100% in week 1 to 53.8% in week 17 post-enrollment.,"['Cancer patients (≥60\xa0years) without concurrent uncontrolled severe medical conditions and a\xa0Karnofsky performance status (KPS) ≥70\xa0were eligible if they were able to use the smartphone app', '54\xa0patients agreed to participate and 29\xa0activated the app and participated in the study', '225 patients screened', 'cancer patients', 'geriatric cancer patients using', 'elderly cancer patients', 'The mean age was 66\xa0years (61-78', 'highly selected elderly cancer patients with modest compliance rates']",['handheld devices'],"['compliance over 1\xa0year, calculated as patient-specific and study date-specific response rate to questions sent as push notifications', 'Daily compliance', 'questionnaires such as the EORTC-QLQ-C30', 'comparison of a\xa0subjective health status item (SPHS) with the physician-rated KPS', 'SPHS and KPS scores', 'individual compliance rate']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",[],"[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C1719958', 'cui_str': 'Push'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",225.0,0.0377686,The average percentage of patients who sent answers at least weekly was 75.0% (SD = 14.8%) and declined from 100% in week 1 to 53.8% in week 17 post-enrollment.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Buergy', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Siefert', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Neumaier', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ganslandt', 'Affiliation': 'Heinrich-Lanz-Center for Digital Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sperk', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Blessing', 'Affiliation': 'Experimental Radiation Oncology, Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Hesser', 'Affiliation': 'Experimental Radiation Oncology, Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Grit', 'Initials': 'G', 'LastName': 'Welzel', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany.'}, {'ForeName': 'Frank Anton', 'Initials': 'FA', 'LastName': 'Giordano', 'Affiliation': 'Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer\xa01-3, 68167, Mannheim, Germany. Frank.Giordano@umm.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-019-01548-0']
2960,32101259,A New Equation for Calculation of Low-Density Lipoprotein Cholesterol in Patients With Normolipidemia and/or Hypertriglyceridemia.,"Importance


Low-density lipoprotein cholesterol (LDL-C), a key cardiovascular disease marker, is often estimated by the Friedewald or Martin equation, but calculating LDL-C is less accurate in patients with a low LDL-C level or hypertriglyceridemia (triglyceride [TG] levels ≥400 mg/dL).
Objective


To design a more accurate LDL-C equation for patients with a low LDL-C level and/or hypertriglyceridemia.
Design, Setting, and Participants


Data on LDL-C levels and other lipid measures from 8656 patients seen at the National Institutes of Health Clinical Center between January 1, 1976, and June 2, 1999, were analyzed by the β-quantification reference method (18 715 LDL-C test results) and were randomly divided into equally sized training and validation data sets. Using TG and non-high-density lipoprotein cholesterol as independent variables, multiple least squares regression was used to develop an equation for very low-density lipoprotein cholesterol, which was then used in a second equation for LDL-C. Equations were tested against the internal validation data set and multiple external data sets of either β-quantification LDL-C results (n = 28 891) or direct LDL-C test results (n = 252 888). Statistical analysis was performed from August 7, 2018, to July 18, 2019.
Main Outcomes and Measures


Concordance between calculated and measured LDL-C levels by β-quantification, as assessed by various measures of test accuracy (correlation coefficient [R2], root mean square error [RMSE], mean absolute difference [MAD]), and percentage of patients misclassified at LDL-C treatment thresholds of 70, 100, and 190 mg/dL.
Results


Compared with β-quantification, the new equation was more accurate than other LDL-C equations (slope, 0.964; RMSE = 15.2 mg/dL; R2 = 0.9648; vs Friedewald equation: slope, 1.056; RMSE = 32 mg/dL; R2 = 0.8808; vs Martin equation: slope, 0.945; RMSE = 25.7 mg/dL; R2 = 0.9022), particularly for patients with hypertriglyceridemia (MAD = 24.9 mg/dL; vs Friedewald equation: MAD = 56.4 mg/dL; vs Martin equation: MAD = 44.8 mg/dL). The new equation calculates the LDL-C level in patients with TG levels up to 800 mg/dL as accurately as the Friedewald equation does for TG levels less than 400 mg/dL and was associated with 35% fewer misclassifications when patients with hypertriglyceridemia (TG levels, 400-800 mg/dL) were categorized into different LDL-C treatment groups.
Conclusions and Relevance


The new equation can be readily implemented by clinical laboratories with no additional costs compared with the standard lipid panel. It will allow for more accurate calculation of LDL-C level in patients with low LDL-C levels and/or hypertriglyceridemia (TG levels, ≤800 mg/dL) and thus should improve the use of LDL-C level in cardiovascular disease risk management.",2020,The new equation can be readily implemented by clinical laboratories with no additional costs compared with the standard lipid panel.,"['8656 patients seen at the National Institutes of Health Clinical Center between January 1, 1976, and June 2, 1999, were analyzed by the β-quantification reference method (18\u202f715 LDL-C test results', 'patients with hypertriglyceridemia ', 'patients with a low LDL-C level and/or hypertriglyceridemia', 'Patients With Normolipidemia and/or Hypertriglyceridemia', 'patients with a low LDL-C level or hypertriglyceridemia (triglyceride [TG] levels ≥400 mg/dL']",[],"['square error [RMSE], mean absolute difference [MAD]), and percentage of patients misclassified at LDL-C treatment thresholds', 'Importance\n\n\nLow-density lipoprotein cholesterol (LDL-C', 'Measures\n\n\nConcordance between calculated and measured LDL-C levels by β-quantification', 'root mean']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0853085', 'cui_str': 'Decreased LDL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]",[],"[{'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}]",,0.0197011,The new equation can be readily implemented by clinical laboratories with no additional costs compared with the standard lipid panel.,"[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sampson', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Ling', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Roa', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'Clinical Center, Department of Laboratory Medicine, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mohmed', 'Initials': 'M', 'LastName': 'Ashmaig', 'Affiliation': 'Prism Health Dx Inc, Austin, Texas.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Warnick', 'Affiliation': 'Prism Health Dx Inc, Austin, Texas.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Sethi', 'Affiliation': 'Pacific Biomarker, Seattle, Washington.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Fleming', 'Affiliation': 'Department of Science and Technology, Laboratory Corporation of America Holdings, Burlington, North Carolina.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Otvos', 'Affiliation': 'NMR Diagnostics, Laboratory Corporation of America Holdings, Burlington, North Carolina.'}, {'ForeName': 'Jeff W', 'Initials': 'JW', 'LastName': 'Meeusen', 'Affiliation': 'Cardiovascular Laboratory Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Delaney', 'Affiliation': 'Cardiovascular Laboratory Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Allan S', 'Initials': 'AS', 'LastName': 'Jaffe', 'Affiliation': 'Division of Clinical Core Laboratory Services, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shamburek', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Amar', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Remaley', 'Affiliation': 'Lipoprotein Metabolism Laboratory, Translational Vascular Medicine Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}]",JAMA cardiology,['10.1001/jamacardio.2020.0013']
2961,32101269,Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial.,"Importance


The application of indocyanine green (ICG) imaging in laparoscopic radical gastrectomy is in the preliminary stages of clinical practice, and its safety and efficacy remain controversial.
Objective


To investigate the safety and efficacy of ICG near-infrared tracer-guided imaging during laparoscopic D2 lymphadenectomy in patients with gastric cancer.
Design, Setting, and Participants


Patients with potentially resectable gastric adenocarcinoma (clinical tumor stage cT1-cT4a, N0/+, M0) were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital between November 2018 and July 2019. Patients were randomly assigned to the ICG group or the non-ICG group. The number of retrieved lymph nodes, rate of lymph node noncompliance, and postoperative recovery data were compared between the groups in a modified intention-to-treat analysis. Statistical analysis was performed from August to September 2019.
Interventions


The ICG group underwent laparoscopic gastrectomy using near-infrared imaging after receiving an endoscopic peritumoral injection of ICG to the submucosa 1 day before surgery.
Main Outcomes and Measures


Total number of retrieved lymph nodes.
Results


Of 266 participants randomized, 133 underwent ICG tracer-guided laparoscopic gastrectomy, and 133 underwent conventional laparoscopic gastrectomy. After postsurgical exclusions, 258 patients were included in the modified intention-to-treat analysis, which comprised 129 patients (86 men and 43 women; mean [SD] age, 57.8 [10.7] years) in the ICG group and 129 patients (87 men and 42 women; mean [SD] age, 60.1 [9.1] years) in the non-ICG group. The mean number of lymph nodes retrieved in the ICG group was significantly more than the mean number retrieved in the non-ICG group (mean [SD], 50.5 [15.9] lymph nodes vs 42.0 [10.3] lymph nodes, respectively; P < .001). Significantly more perigastric and extraperigastric lymph nodes were retrieved in the ICG group than in the non-ICG group. In addition, the mean total number of lymph nodes retrieved in the ICG group within the scope of D2 lymphadenectomy was also significantly greater than the mean number retrieved in the non-ICG group (mean [SD], 49.6 [15.0] lymph nodes vs 41.7 [10.2] lymph nodes, respectively; P < .001). The lymph node noncompliance rate of the ICG group (41 of 129 patients [31.8%]) was lower than that of the non-ICG group (74 of 129 patients [57.4%]; P < .001). The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
Conclusions and Relevance


Indocyanine green can noticeably improve the number of lymph node dissections and reduce lymph node noncompliance without increased complications in patients undergoing D2 lymphadenectomy. Indocyanine green fluorescence imaging can be performed for routine lymphatic mapping during laparoscopic gastrectomy, especially total gastrectomy.
Trial Registration


ClinicalTrials.gov Identifier: NCT03050879.",2020,"The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
","['Patients With Gastric Cancer', 'patients undergoing D2 lymphadenectomy', 'Participants\n\n\nPatients with potentially resectable gastric adenocarcinoma (clinical tumor stage cT1-cT4a, N0/+, M0) were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital between November 2018 and July 2019', '266 participants randomized, 133 underwent', 'patients with gastric cancer', '258 patients were included in the modified intention-to-treat analysis, which comprised 129 patients (86 men and 43 women; mean [SD] age, 57.8 [10.7] years) in the ICG group and 129 patients (87 men and 42 women; mean [SD] age, 60.1']","['ICG', 'ICG tracer-guided laparoscopic gastrectomy', 'ICG near-infrared tracer-guided imaging during laparoscopic D2 lymphadenectomy', 'indocyanine green (ICG) imaging', 'laparoscopic gastrectomy', 'Indocyanine Green Tracer-Guided Lymph Node Dissection', 'Indocyanine', 'Laparoscopic Radical Gastrectomy', 'conventional laparoscopic gastrectomy', 'ICG group or the non-ICG']","['severity of complications', 'mean total number of lymph nodes', 'Measures\n\n\nTotal number of retrieved lymph nodes', 'postoperative recovery process', 'mean number of lymph nodes', 'number of retrieved lymph nodes, rate of lymph node noncompliance, and postoperative recovery data', 'perigastric and extraperigastric lymph nodes', 'lymph node noncompliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0565313', 'cui_str': 'Radical gastrectomy (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",258.0,0.0898331,"The postoperative recovery process was comparable, and no significant difference was found between the ICG and non-ICG groups in the incidence (20 of 129 patients [15.5%] vs 21 of 129 [16.3%], respectively; P = .86) or severity of complications within 30 days after surgery.
","[{'ForeName': 'Qi-Yue', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Xie', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhong', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jia-Bin', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jian-Xian', 'Initials': 'JX', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Long-Long', 'Initials': 'LL', 'LastName': 'Cao', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ru-Hong', 'Initials': 'RH', 'LastName': 'Tu', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ze-Ning', 'Initials': 'ZN', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ju-Li', 'Initials': 'JL', 'LastName': 'Lin', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Hua-Long', 'Initials': 'HL', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chao-Hui', 'Initials': 'CH', 'LastName': 'Zheng', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Chang-Ming', 'Initials': 'CM', 'LastName': 'Huang', 'Affiliation': 'Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.6033']
2962,32094516,Effects of hybrid-functional electrical stimulation (FES) rowing whole-body exercise on neurologic improvement in subacute spinal cord injury: secondary outcomes analysis of a randomized controlled trial.,"STUDY DESIGN


Secondary outcome measures analysis of a randomized, controlled study.
OBJECTIVE


To assess the effects of hybrid-functional electrical stimulation (FES) rowing on motor and sensory recovery in individuals with spinal cord injury (SCI) 6-18 months post injury.
SETTING


Outpatient rehabilitation network.
METHODS


25 participants 6-12 months after SCI were randomly assigned to hybrid-FES rowing (n = 10) or standard of care (n = 15) groups. The hybrid-FES rowing group completed 6 months of rowing scheduled 3 times per week for 26 weeks at an exercise intensity of 70-85% of maximal heart rate. The standard of care group either participated in an arm ergometer exercise program (n = 6) or a waitlist without an explicit exercise program (n = 9). Changes in motor score and combined sensory score of the International Standards for Neurological Classification of SCI (ISNCSCI) were analyzed.
RESULTS


Both groups demonstrated increases in motor and combined sensory scores, but no significant differences were noted between intervention groups (motor difference mean ↑1.3 (95% CI, -1.9 to 4.4), combined sensory difference mean ↓10 (-30 to 18)). There was an average of 63% adherence to the hybrid-FES rowing protocol, with no significant correlation in changes in motor or combined sensory score in the hybrid-FES rowing group with total distance or time rowed.
CONCLUSIONS


No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.",2020,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"['individuals with spinal cord injury (SCI) 6-18 months post injury', '25 participants 6-12 months after SCI', 'Outpatient rehabilitation network', 'subacute spinal cord injury']","['hybrid-FES rowing', 'hybrid-functional electrical stimulation (FES) rowing', 'hybrid-FES rowing (n\u2009=\u200910) or standard of care', 'hybrid-functional electrical stimulation (FES) rowing whole-body exercise', 'care group either participated in an arm ergometer exercise program (n\u2009=\u20096) or a waitlist without an explicit exercise program']","['motor score and combined sensory score', 'motor and combined sensory scores', 'motor or combined sensory score', 'neurologic improvement']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",25.0,0.116675,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA. rchou1@partners.org.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Solinsky', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}]",Spinal cord,['10.1038/s41393-020-0445-3']
2963,32101271,Effects of Antipsychotic Medication on Brain Structure in Patients With Major Depressive Disorder and Psychotic Features: Neuroimaging Findings in the Context of a Randomized Placebo-Controlled Clinical Trial.,"Importance


Prescriptions for antipsychotic medications continue to increase across many brain disorders, including off-label use in children and elderly individuals. Concerning animal and uncontrolled human data suggest antipsychotics are associated with change in brain structure, but to our knowledge, there are no controlled human studies that have yet addressed this question.
Objective


To assess the effects of antipsychotics on brain structure in humans.
Design, Setting, and Participants


Prespecified secondary analysis of a double-blind, randomized, placebo-controlled trial over a 36-week period at 5 academic centers. All participants, aged 18 to 85 years, were recruited from the multicenter Study of the Pharmacotherapy of Psychotic Depression II (STOP-PD II). All participants had major depressive disorder with psychotic features (psychotic depression) and were prescribed olanzapine and sertraline for a period of 12 to 20 weeks, which included 8 weeks of remission of psychosis and remission/near remission of depression. Participants were then were randomized to continue receiving this regimen or to be switched to placebo and sertraline for a subsequent 36-week period. Data were analyzed between October 2018 and February 2019.
Interventions


Those who consented to the imaging study completed a magnetic resonance imaging (MRI) scan at the time of randomization and a second MRI scan at the end of the 36-week period or at time of relapse.
Main Outcomes and Measures


The primary outcome measure was cortical thickness in gray matter and the secondary outcome measure was microstructural integrity of white matter.
Results


Eighty-eight participants (age range, 18-85 years) completed a baseline scan; 75 completed a follow-up scan, of which 72 (32 men and 40 women) were useable for final analyses. There was a significant treatment-group by time interaction in cortical thickness (left, t = 3.3; P = .001; right, t = 3.6; P < .001) but not surface area. No significant interaction was found for fractional anisotropy, but one for mean diffusivity of the white matter skeleton was present (t = -2.6, P = .01). When the analysis was restricted to those who sustained remission, exposure to olanzapine compared with placebo was associated with significant decreases in cortical thickness in the left hemisphere (β [SE], 0.04 [0.009]; t34.4 = 4.7; P <.001), and the right hemisphere (β [SE], 0.03 [0.009]; t35.1 = 3.6; P <.001). Post hoc analyses showed that those who relapsed receiving placebo experienced decreases in cortical thickness compared with those who sustained remission.
Conclusions and Relevance


In this secondary analysis of a randomized clinical trial, antipsychotic medication was shown to change brain structure. This information is important for prescribing in psychiatric conditions where alternatives are present. However, adverse effects of relapse on brain structure support antipsychotic treatment during active illness.
Trial Registration


ClinicalTrials.gov Identifier: NCT01427608.",2020,"There was a significant treatment-group by time interaction in cortical thickness (left, t = 3.3; P = .001; right, t = 3.6; P < .001) but not surface area.","['Patients With Major Depressive Disorder and Psychotic Features', 'Eighty-eight participants (age range, 18-85 years) completed a baseline scan; 75 completed a follow-up scan, of which 72 (32 men and 40 women', 'humans', 'children and elderly individuals', 'All participants had major depressive disorder with psychotic features (psychotic depression', 'All participants, aged 18 to 85 years, were recruited from the multicenter Study of the Pharmacotherapy of Psychotic Depression II (STOP-PD II']","['Antipsychotic Medication', 'placebo', 'magnetic resonance imaging (MRI) scan', 'placebo and sertraline', 'antipsychotics', 'olanzapine', 'olanzapine and sertraline', 'Placebo']","['cortical thickness in gray matter', 'mean diffusivity of the white matter skeleton', 'right hemisphere', 'cortical thickness', 'time interaction in cortical thickness', 'remission of psychosis and remission/near remission of depression', 'microstructural integrity of white matter']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0816871', 'cui_str': 'Skeleton'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}]",,0.436468,"There was a significant treatment-group by time interaction in cortical thickness (left, t = 3.3; P = .001; right, t = 3.6; P < .001) but not surface area.","[{'ForeName': 'Aristotle N', 'Initials': 'AN', 'LastName': 'Voineskos', 'Affiliation': 'Kimel Family Translational Imaging-Genetics Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin W', 'Initials': 'EW', 'LastName': 'Dickie', 'Affiliation': 'Kimel Family Translational Imaging-Genetics Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicholas H', 'Initials': 'NH', 'LastName': 'Neufeld', 'Affiliation': 'Kimel Family Translational Imaging-Genetics Laboratory, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'UMass Memorial Health Care, University of Massachusetts Medical School, Worcester.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Whyte', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Meyers', 'Affiliation': 'Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hoptman', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, Orangeburg, New York.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Lerch', 'Affiliation': 'Mouse Imaging Centre, The Hospital for Sick Children, Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Flint', 'Affiliation': 'University Health Network, Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.0036']
2964,31904707,A Multicenter Randomized Controlled Trial of Intensive Group Therapy for Tobacco Treatment in HIV-Infected Cigarette Smokers.,"BACKGROUND


Tobacco use has emerged as the leading killer of persons living with HIV (PLWH) in the United States. Little is known about the efficacy of tobacco treatment strategies in PLWH.
DESIGN


Randomized controlled trial comparing Positively Smoke Free (PSF), an intensive group therapy intervention targeting HIV-infected smokers, to brief advice to quit. All participants were offered a 12-week supply of nicotine patches.
METHODS


A cohort of 450 PLWH smokers, recruited from HIV-care centers in the Bronx, New York, and Washington, DC, were randomized 1:1 into the PSF or brief advice to quit conditions. PSF is an 8-session program tailored to address the needs and concerns of HIV-infected smokers and delivered by a trained smoking cessation counselor and PLWH ex-smoker peer pair. The primary outcome was biochemically confirmed, 7-day point-prevalence abstinence at 6 months.
RESULTS


In the intention to treat analysis, PSF condition subjects had nearly double the quit rate of controls, 13% vs. 6.6% [odds ratio = 2.10 (95% confidence interval = 1.10 to 4.14), P = 0.04], at 3 months, but no significant difference in abstinence was observed at 6 months. PSF participants exhibited lower nicotine dependence and higher self-efficacy to resist smoking temptations at both 3 and 6 months compared with controls. Lower educational attainment, current cocaine use, past use of nicotine patches, and higher distress tolerance were significant predictors of continued smoking at 6 months.
CONCLUSIONS


These findings suggest a role for group therapy among tobacco treatments for PLWH smokers, but strategies to augment the durability of early effects are needed.",2020,PSF participants exhibited lower nicotine dependence and higher self-efficacy to resist smoking temptations at both three and six months compared to controls.,"['persons living with HIV (PLWH', '450 PLWH smokers, recruited from HIV-care centers in the Bronx, New York and Washington, DC', 'HIV-infected cigarette smokers']","['nicotine patches', 'intensive group therapy', 'Positively Smoke Free (PSF', 'PSF or brief advice to quit conditions']","['biochemically-confirmed, seven-day point-prevalence abstinence', 'abstinence', 'nicotine dependence and higher self-efficacy to resist smoking temptations', 'quit rate']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",,0.0907941,PSF participants exhibited lower nicotine dependence and higher self-efficacy to resist smoking temptations at both three and six months compared to controls.,"[{'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Stanton', 'Affiliation': 'Behavioral Health and Health Policy Practice, Westat, Rockville, MD.'}, {'ForeName': 'Princy N', 'Initials': 'PN', 'LastName': 'Kumar', 'Affiliation': 'Medicine, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Alyson B', 'Initials': 'AB', 'LastName': 'Moadel', 'Affiliation': ''}, {'ForeName': 'Chinazo O', 'Initials': 'CO', 'LastName': 'Cunningham', 'Affiliation': 'Medicine.'}, {'ForeName': 'Clyde B', 'Initials': 'CB', 'LastName': 'Schechter', 'Affiliation': 'Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Ryung S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuter', 'Affiliation': 'Medicine.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002271']
2965,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
2966,32101262,Assessment of Long-term Benefit of Intensive Blood Pressure Control on Residual Life Span: Secondary Analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).,"Importance


High blood pressure (BP) is a leading contributor to premature mortality worldwide. The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated a 27% reduction in all-cause death with intensive (vs standard) BP control. However, traditional reporting of survival benefits is not readily interpretable outside medical communities.
Objective


To estimate residual life span and potential survival gains with intensive compared with standard BP control in the SPRINT trial using validated nonparametric age-based methods.
Design, Setting, and Participants


This secondary analysis of data from an open-label randomized clinical trial included data from 102 enrolling clinical sites in the United States. Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013. Data analysis occurred from May 2019 to December 2019.
Interventions


A 1:1 randomization to intensive (target, <120 mm Hg) or standard (target, <140 mm Hg) systolic BP targets.
Main Outcomes and Measures


We calculated age-based estimates of projected survival (at a given age) using baseline age rather than time from randomization as the time axis. In each treatment arm at every year of age, residual life span was estimated using the area under the survival curve, up to a maximum of 95 years. Differences in areas under the survival curves reflect the estimated treatment benefits on projected survival.
Results


A total of 9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals). Mean survival benefits with intensive vs standard BP control ranged from 6 months to up to 3 years. At age 50 years, the estimated residual survival was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years]; P = .008). At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years]; P = .03). Absolute survival gains with intensive vs standard BP control decreased with age, but the relative benefits were consistent (4% to 9%).
Conclusions and Relevance


Intensive BP control improves projected survival by 6 months to 3 years among middle-aged and older adults at high cardiovascular risk but without diabetes mellitus. These post hoc actuarial analyses from SPRINT support the survival benefits of intensive BP control, especially among middle-aged adults at risk.
Trial Registration


ClinicalTrials.gov Identifier: NCT01206062.",2020,"At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years];","['Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013', 'middle-aged adults at risk', '9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals', 'middle-aged and older adults at high cardiovascular risk but without diabetes mellitus', 'was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years', 'was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years', '102 enrolling clinical sites in the United States']","['Intensive Blood Pressure Control', 'standard BP control']","['residual survival', 'Absolute survival gains', 'Main Outcomes and Measures\n\n\nWe calculated age-based estimates of projected survival', 'survival benefits', 'blood pressure (BP', 'residual life span and potential survival gains', 'Mean survival benefits', 'Residual Life Span', 'Systolic Blood Pressure Intervention Trial (SPRINT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0870809', 'cui_str': 'Lifespan'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",9361.0,0.209177,"At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years];","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Section for Research, Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}]",JAMA cardiology,['10.1001/jamacardio.2019.6192']
2967,31805989,"Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects.","BACKGROUND


PF-06650833 is a potent, selective inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4). Two randomized, double-blind, sponsor-open phase 1 studies evaluated the safety, pharmacokinetics, and pharmacodynamics of single (SAD) and multiple ascending doses (MAD) of PF-06650833 immediate-release (IR) and modified-release (MR) oral formulations in healthy adult subjects.
METHODS


Study 1 (NCT02224651) was a 96-day, placebo-substitution, SAD study of once-daily (QD) oral PF-06650833 IR 1 to 6000 mg and MR 30 to 300 mg in fasted and fed states. Study 2 (NCT02485769) was a 14-day, placebo-controlled, MAD study of PF-06650833 IR 25 to 750 mg twice daily, IR 1000 mg four times per day, IR 330 mg three times per day, and MR 300 mg QD.
RESULTS


PF-06650833 was generally well tolerated, with no dose-limiting treatment-emergent adverse events (TEAEs) identified in either study. TEAEs were generally mild in severity, with headache, gastrointestinal disorders, and acne most commonly reported. No serious AEs or deaths were reported. A maximum tolerated dose was not established in either study. In the SAD study, food intake delayed absorption of IR 30 mg and increased total exposure by 33%. Delayed absorption was achieved with the MR formulation (T max  of 1 h versus 8 h for IR 100 mg and MR 100 mg formulations, respectively). Food had no effect on total exposure for MR 30 mg, but reduced half-life 1.8-fold and increased C max  by 62%. In the MAD study, accumulation ranged from 0.9-fold to 1.4-fold for AUC tau  and 0.9-fold to 1.3-fold for C max . Less than 1% of the dose was recovered unchanged in urine for all dose groups, with renal clearance ranging from 14 to 23 mL/min for IR < 750 mg and MR 300 mg. There was a sustained decrease in serum high-sensitivity C-reactive protein for IR ≥ 250 mg and MR 300 mg. Based on the cholesterol/hydroxycholesterol ratio, no apparent CYP3A induction or inhibition was observed.
CONCLUSIONS


PF-06650833, the first IRAK4 inhibitor to enter clinical development, has a favorable safety and pharmacokinetic profile and has shown evidence of pharmacological effect. The data support continued evaluation in human clinical trials for the treatment of rheumatic and autoimmune diseases.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02224651, registered 25 August 2014; NCT02485769, registered 30 June 2015.",2019,There was a sustained decrease in serum high-sensitivity C-reactive protein for IR ≥ 250 mg and MR 300 mg.,"['healthy adult subjects', 'registered 25 August 2014; NCT02485769, registered 30 June 2015', 'healthy subjects']","['placebo-substitution, SAD study of once-daily (QD) oral PF-06650833 IR 1 to 6000\u2009mg and MR 30 to 300\u2009mg in fasted and fed states', 'placebo', 'MR 300\u2009mg QD']","['Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor', 'safety, pharmacokinetics, and pharmacodynamics of single (SAD) and multiple ascending doses (MAD) of PF-06650833 immediate-release (IR) and modified-release (MR) oral formulations', 'total exposure', 'Delayed absorption', 'serum high-sensitivity C-reactive protein', 'cholesterol/hydroxycholesterol ratio, no apparent CYP3A induction or inhibition']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4549236', 'cui_str': '1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide'}, {'cui': 'C3842326', 'cui_str': 'Six thousand'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C4549236', 'cui_str': '1-(((2S,3S,4S)-3-ethyl-4-fluoro-5-oxopyrrolidin-2-yl)methoxy)-7-methoxyisoquinoline-6-carboxamide'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome P-450 CYP3A'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",,0.0391092,There was a sustained decrease in serum high-sensitivity C-reactive protein for IR ≥ 250 mg and MR 300 mg.,"[{'ForeName': 'Spencer I', 'Initials': 'SI', 'LastName': 'Danto', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA. spencer.i.danto@pfizer.com.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Shojaee', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Ravi Shankar P', 'Initials': 'RSP', 'LastName': 'Singh', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Gilbert', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Zorayr', 'Initials': 'Z', 'LastName': 'Manukyan', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Kilty', 'Affiliation': 'Immunology and Inflammation Research Unit, Pfizer Worldwide Research & Development, Cambridge, MA, 02139, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-2008-6']
2968,31815649,Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT.,"BACKGROUND


To evaluate the effect of upadacitinib on patient-reported outcomes (PROs) in patients with RA who had an inadequate response to csDMARDs.
METHODS


Patients in SELECT-NEXT, a randomised controlled trial, were on a background of csDMARDs and received upadacitinib 15 mg and 30 mg or placebo daily for 12 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS). Least squares mean (LSM) changes were based on mixed-effect repeated measure models. Percentages of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT) were determined; group comparisons used chi-square tests.
RESULTS


Data from 661 patients were analysed. Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12. Significantly, more upadacitinib-treated patients (both doses, P < 0.05) reported improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains). For most PROs, the incremental NNT with upadacitinib to report clinically meaningful improvement from baseline ranged from 4 to 8 patients.
CONCLUSIONS


Upadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability among csDMARD-IR patients with RA.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02675426. Retrospectively registered 5 February 2016.",2019,"Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12.","['patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs', '661 patients were analysed', 'patients with RA who had an inadequate response to csDMARDs']","['placebo', 'upadacitinib 15\u2009mg and 30\u2009mg or placebo']","['FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS', 'Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue', 'differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT', 'global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability', 'PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS', 'improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness (finding)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0222045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",661.0,0.164941,"Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12.","[{'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pope', 'Affiliation': 'University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Namita', 'Initials': 'N', 'LastName': 'Tundia', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. namita.tundia@abbvie.com.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Camp', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Ganguli', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Fuldeore', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Goldschmidt', 'Affiliation': 'Analysis Group, Inc., New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schiff', 'Affiliation': 'University of Colorado, Denver, CO, USA.'}]",Arthritis research & therapy,['10.1186/s13075-019-2037-1']
2969,31929466,The Efficacy of Intensive Short-Term Dynamic Psychotherapy for Social Anxiety Disorder: Randomized Trial and Substudy of Emphasizing Feeling Versus Defense Work.,"This research examined the efficacy of intensive short-term dynamic psychotherapy (ISTDP) in the treatment of social anxiety disorder (SAD) and compared the therapeutic outcomes of ISTDP when feeling focus or defense work is emphasized. A three-group randomized design with 6-month follow-up was used. Forty-one subjects were selected among volunteer college students diagnosed with SAD. They were assigned randomly into three groups; 14 cases to feeling-focused ISTDP (FF-ISTDP) group, 14 cases to defense-focused ISTDP (DF-ISTDP) group, and 13 cases to a control group. All subjects were evaluated at pretest, posttest, and six-month follow-up through clinical interviewing using DSM-5 criteria for SAD along with the Liebowitz Social Anxiety Scale. Each experimental group had a course of 8 to 10 sessions of ISTDP treatment. Analysis of variance showed that ISTDP is an effective treatment for SAD compared with a control group. No outcome differences were found between FF-ISTDP and DF-ISTDP in treating SAD.",2020,This research examined the efficacy of intensive short-term dynamic psychotherapy (ISTDP) in the treatment of social anxiety disorder (SAD) and compared the therapeutic outcomes of ISTDP when feeling focus or defense work is emphasized.,"['Social Anxiety Disorder', 'Forty-one subjects were selected among volunteer college students diagnosed with SAD', 'social anxiety disorder (SAD']","['Intensive Short-Term Dynamic Psychotherapy', 'ISTDP', 'feeling-focused ISTDP (FF-ISTDP) group, 14 cases to defense-focused ISTDP (DF-ISTDP', 'intensive short-term dynamic psychotherapy (ISTDP']",['FF-ISTDP and DF-ISTDP'],"[{'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",[],41.0,0.0152694,This research examined the efficacy of intensive short-term dynamic psychotherapy (ISTDP) in the treatment of social anxiety disorder (SAD) and compared the therapeutic outcomes of ISTDP when feeling focus or defense work is emphasized.,"[{'ForeName': 'Fateh', 'Initials': 'F', 'LastName': 'Rahmani', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbass', 'Affiliation': 'Centre for Emotions and Health, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Azad', 'Initials': 'A', 'LastName': 'Hemmati', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Sahar Rezaei', 'Initials': 'SR', 'LastName': 'Mirghaed', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Ghaffari', 'Affiliation': 'Department of Psychology, University of Kurdistan, Sanandaj, Iran.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001097']
2970,32085946,"""Healthy""/""Unhealthy"" Food Brands Influence Health, Calorie, and Price Ratings of Food.","OBJECTIVE


To assess the effect of healthy or unhealthy food brands on consumer ratings of a food's perceived healthfulness, caloric content, and estimated price.
METHODS


Using a crossover design, 35 adults aged 18-25 years scored a variety of healthy and unhealthy foods paired with ""healthy"" or ""unhealthy"" brands or with no brand present, on their healthfulness, caloric content, and estimated price. For each outcome measure, ANOVA was used to evaluate the effect of brand condition on healthy and unhealthy foods.
RESULTS


Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001). Pairing a healthy food with an ""unhealthy brand"" led to decreased ratings of healthfulness (P < .001), increased estimates of caloric content (P < .001), and decreased price (P < .001).
CONCLUSIONS AND IMPLICATIONS


These findings extend previous research showing that brands may influence perceptions of food products. Future studies are needed to understand the implications of pairing healthy foods with ""unhealthy brands"" on actual food intake.",2020,"Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001).","['35 adults aged 18-25 years scored a variety of healthy and unhealthy foods paired with ""healthy"" or ""unhealthy"" brands or with no brand present, on their healthfulness, caloric content, and estimated price']",['healthy or unhealthy food brands'],"['ratings of healthfulness', 'caloric content', 'increased price']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",35.0,0.0443924,"Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001).","[{'ForeName': 'Travis D', 'Initials': 'TD', 'LastName': 'Masterson', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH. Electronic address: Travis.D.Masterson@dartmouth.edu.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Florissi', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Clark', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, NH.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gilbert-Diamond', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.01.008']
2971,32087837,Effect of a web-based relapse prevention program on abstinence among Japanese drug users: A pilot randomized controlled trial.,"BACKGROUND


Internet-based intervention could help drug users recover from drug dependence. This study evaluated the effectiveness of a newly developed web-based relapse prevention program (e-SMARPP) for people with a drug problem, including the use of methamphetamine, in Japan.
METHODS


The study was a pilot randomized controlled trial comprised of 48 psychiatric outpatients diagnosed with drug use disorder. The participants were randomly assigned to an eight-week, six-session web-based relapse prevention program (an intervention group) or only web-based self-monitoring (a control group). The primary outcome was the duration of abstinence from a primary drug during the intervention and relapse risk. Secondary outcomes included motivation to change, self-efficacy, and money spent on drugs. The outcomes, except for the duration of abstinence during the intervention, were assessed at baseline, 2-, 5-, and 8-months. Program completion rate was also assessed.
RESULTS


No significant difference was observed between the intervention and the control groups for the primary and the secondary outcomes. The effect size of the duration of abstinence during the intervention was d = 0.42, which was comparable to previous studies. In the intervention group, about 26% did not complete the entire intervention.
CONCLUSIONS


e-SMARPP failed to demonstrate efficacy, however, is potentially helpful for enhancing abstinence. The low attrition rate may suggest the acceptance and feasibility of the program. Further improvement of the program and evaluation in a full-scale trial are needed.",2020,No significant difference was observed between the intervention and the control groups for the primary and the secondary outcomes.,"['people with a drug problem, including the use of methamphetamine, in Japan', 'Japanese drug users', '48 psychiatric outpatients diagnosed with drug use disorder']","['newly developed web-based relapse prevention program (e-SMARPP', 'six-session web-based relapse prevention program (an intervention group) or only web-based self-monitoring', 'web-based relapse prevention program']","['duration of abstinence from a primary drug during the intervention and relapse risk', 'motivation to change, self-efficacy, and money spent on drugs', 'Program completion rate', 'duration of abstinence']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0338666', 'cui_str': 'Drug Users'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0013222', 'cui_str': 'Drug Use Disorders'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",48.0,0.131056,No significant difference was observed between the intervention and the control groups for the primary and the secondary outcomes.,"[{'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Takano', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan. Electronic address: ayumi-takano@umin.ac.jp.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Psychiatric Nursing, The University of Tokyo, 7-3-1 Hongo, Bunkyo, Tokyo 113-0033, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Shinozaki', 'Affiliation': 'Department of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, 6-3-1 Sinjuku, Katsushika-ku, Tokyo 125-8585.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Drug Dependence Research, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo, Tokyo 113-0033, Japan.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.001']
2972,32087841,Motivational interviewing and culture for urban Native American youth (MICUNAY): A randomized controlled trial.,"To date, few programs that integrate traditional practices with evidence-based practices have been developed, implemented, and evaluated with urban American Indians/Alaska Natives (AI/ANs) using a strong research design. The current study recruited urban AI/AN teens across northern, central, and southern California during 2014-2017 to participate in a randomized controlled trial testing two cultural interventions that addressed alcohol and other drug (AOD) use. Adolescents were 14-18 years old (inclusive), and either verbally self-identified as AI/AN or were identified as AI/AN by a parent or community member. We tested the added benefit of MICUNAY (Motivational Interviewing and Culture for Urban Native American Youth) to a CWG (Community Wellness Gathering). MICUNAY was a group intervention with three workshops that integrated traditional practices with motivational interviewing. CWGs were cultural events held monthly in each city. AI/AN urban adolescents (N = 185) completed a baseline survey, were randomized to MICUNAY + CWG or CWG only, and then completed a three- and six-month follow-up. We compared outcomes on AOD use, spirituality, and cultural identification. Overall, AOD use remained stable over the course of the study, and we did not find significant differences between these two groups over time. It may be that connecting urban AI/AN adolescents to culturally centered activities and resources is protective, which has been shown in other work with this population. Given that little work has been conducted in this area, longer term studies of AOD interventions with urban AI/AN youth throughout the U.S. are suggested to test the potential benefits of culturally centered interventions.",2020,"Overall, AOD use remained stable over the course of the study, and we did not find significant differences between these two groups over time.","['urban Native American youth (MICUNAY', 'Urban Native American Youth', 'urban AI/AN teens across northern, central, and southern California during 2014-2017 to participate', 'Adolescents were 14-18\xa0years old (inclusive), and either verbally self-identified as AI/AN or were identified as AI/AN by a parent or community member', 'AN urban adolescents (N\xa0=\xa0185) completed a baseline survey']","['Motivational interviewing and culture', 'integrated traditional practices with motivational interviewing', ' CWG or CWG', 'cultural interventions that addressed alcohol and other drug (AOD) use']","['AOD use, spirituality, and cultural identification']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",,0.0320976,"Overall, AOD use remained stable over the course of the study, and we did not find significant differences between these two groups over time.","[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': ""D'Amico"", 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America. Electronic address: damico@rand.org.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Dickerson', 'Affiliation': 'UCLA Integrated Substance Abuse Programs, Semel Institute for Neuroscience and Human Behavior David Geffen School of Medicine, 11075 Santa Monica Blvd., Ste. 200, Los Angeles, CA 90025, United States of America.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America.'}, {'ForeName': 'Carrie L', 'Initials': 'CL', 'LastName': 'Johnson', 'Affiliation': 'Sacred Path Indigenous Wellness Center, LA, CA 90017, United States of America.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Agniel', 'Affiliation': 'RAND Corporation, 1776 Main St., Santa Monica, CA 90401, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.011']
2973,31302802,An Exploratory RCT to Support Gamblers' Intentions to Stick to Monetary Limits: A Brief Intervention Using Action and Coping Planning.,"The aim of this study was to investigate the feasibility and impact of an action and coping planning intervention deployed in gambling venues to improve adherence to expenditure limits. We conducted a 2-group parallel-block randomised controlled trial comparing one 20-min session of action and coping planning to an assessment alone. Gamblers who were intending to set a monetary limit on EGMs (n = 184) were recruited in venues and administered the intervention prior to gambling. Measures were adherence to self-identified gambling limits and adherence to expenditure intentions at 30-days post-intervention using the Time Line Follow-Back. The intervention was feasible in terms of recruitment and willingness of gamblers to engage in a pre-gambling intervention. Most gamblers enacted strategies to limit their gambling prior to entering the venue, albeit these limits were on average higher than the Australian low risk gambling guidelines. In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment. However, Moderate Risk/Problem Gamblers in the Intervention group spent less (a median of $60 less) than intended (median $100) within the venue. All intervention participants intended to spend significantly less in the 30 days after the intervention compared to the amount spent in the 30 days prior to the intervention. This reduction was not found for participants in the control group. A simple brief intervention appears feasible in gambling venues and have an impact on gambling intentions over the short term.",2020,"In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment.",['Gamblers who were intending to set a monetary limit on EGMs (n\u2009=\u2009184) were recruited in venues and administered the intervention prior to gambling'],"['action and coping planning intervention', 'action and coping planning']","['gambling intentions', 'adherence to self-identified gambling limits and adherence to expenditure intentions']","[{'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",60.0,0.0387778,"In terms of impact, the intervention did not improve adherence to limits at post or 30-day follow-up assessment.","[{'ForeName': 'Simone N', 'Initials': 'SN', 'LastName': 'Rodda', 'Affiliation': 'School of Population Health, Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. s.rodda@auckland.ac.nz.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Bagot', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Melbourne Brain Centre, 245 Burgundy Street, Heidelberg, VIC, 3084, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Turning Point, Eastern Health, 110 Church Street, Richmond, VIC, 3121, Australia.'}, {'ForeName': 'Dan I', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Turning Point, Eastern Health, 110 Church Street, Richmond, VIC, 3121, Australia.'}]",Journal of gambling studies,['10.1007/s10899-019-09873-w']
2974,32086442,"The effects of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury: a randomised controlled trial.","STUDY DESIGN


A multi-centred, single-blinded randomised controlled trial.
OBJECTIVES


To determine the effect of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury (SCI).
SETTINGS


Seven hospitals in Australia and Asia.
METHODS


One hundred and twenty people with recent SCI undergoing inpatient rehabilitation were randomised to either a Treatment or Control Group. One major muscle group from an upper or lower limb was selected if the muscle had grade 1 or grade 2 strength on a standard six-point manual muscle test. Participants allocated to the Treatment Group performed 10,000 isolated contractions of the selected muscle group, as well as usual care in 48 sessions over 8 weeks. Participants allocated to the Control Group received usual care alone. Participants were assessed at baseline and 8 weeks by a blinded assessor. The primary outcome was voluntary muscle strength on a 13-point manual muscle test. There were three secondary outcomes capturing therapists' and participants' perceptions of strength and function.
RESULTS


The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group. There were no notable between-group differences on any secondary outcome.
CONCLUSION


Ten thousand isolated contractions of very weak muscles in people with SCI over 8 weeks has either no or a very small effect on voluntary strength.",2020,The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group.,"['One hundred and twenty people with recent SCI undergoing inpatient rehabilitation', 'people with spinal cord injury (SCI', 'Seven hospitals in Australia and Asia', 'people with spinal cord injury']",['Control Group received usual care alone'],"['voluntary strength', 'perceptions of strength and function', 'voluntary muscle strength on a 13-point manual muscle test']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength (assessment scale)'}]",10000.0,0.21565,The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group.,"[{'ForeName': 'Lydia W', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health Sciences, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Joanne V', 'Initials': 'JV', 'LastName': 'Glinsky', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health Sciences, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Md Shofiqul', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Muzaffor', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Spinal Injuries Unit, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Kataria', 'Affiliation': 'Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Redhead', 'Affiliation': 'Spinal Injuries Unit, Royal Rehab, Ryde, NSW, Australia.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Guangdong Work Injury Rehabilitation Hospital, Guangdong, China.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Gollan', 'Affiliation': 'Queensland Spinal Cord Injuries Service, Metro South Health, Brisbane, QLD, Australia.'}, {'ForeName': 'Punam D', 'Initials': 'PD', 'LastName': 'Costa', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Denis', 'Affiliation': 'Spinal Injuries Unit, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Ben', 'Affiliation': 'NSW Spinal Outreach Service, Ryde, NSW, Australia.'}, {'ForeName': 'Lovely', 'Initials': 'L', 'LastName': 'Chaudhary', 'Affiliation': 'Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Guangdong Work Injury Rehabilitation Hospital, Guangdong, China.'}, {'ForeName': 'Md Abu Khayer', 'Initials': 'MAK', 'LastName': 'Hasnat', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Yeomans', 'Affiliation': 'Spinal Injuries Unit, Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Gandevia', 'Affiliation': 'Neuroscience Research Australia (NeuRA), University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health Sciences, University of Sydney, St Leonards, NSW, Australia. lisa.harvey@sydney.edu.au.'}]",Spinal cord,['10.1038/s41393-020-0439-1']
2975,32080009,"A Long-Term Follow-up, Multicenter, Comparative Study of the Radiologic, and Clinical Results Between a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramics (BGS-7) Intervertebral Spacer and Titanium Cage in 1-Level Posterior Lumbar Interbody Fusion.","STUDY DESIGN


This is a prospective, stratified randomized, multicenter, 4-year follow-up study.
OBJECTIVE


The authors aimed to evaluate the long-term clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics (BGS-7) spacers in 1-level posterior lumbar interbody fusion (PLIF) at a 4-year follow-up.
SUMMARY OF BACKGROUND DATA


According to 1-year follow-up results, BGS-7 spacer showed similar fusion rates and clinical outcomes compared with titanium cage. A long-term follow-up study beyond 2 years is necessary to investigate the status of intervertebral bone graft volumes. Moreover, longer follow-up is mandatory to also evaluate the safety and efficacy of BGS-7 spacers, because they remain in the intervertebral space for a long time.
MATERIALS AND METHODS


In this prospective, randomized, multicenter, 4-year follow-up study, we evaluated 62 of the 74 patients who underwent 1-level PLIF. During 1-level PLIF, titanium cages filled with autologous local bone were inserted into the control group patients and BGS-7 spacers were inserted to the experimental group patients. Bone fusion was evaluated by plain radiography and thin-section computed tomography. Visual Analog Scale (VAS), the Oswestry Disability Index (ODI), Short Form-36 Health Survey (SF-36), and evaluation of safety were conducted after 48 months.
RESULTS


Computed tomography scan showed a bone fusion rate of 90.6% in the BGS-7 spacer group and 93.3% in the control group, with no significant differences between groups. The BGS-7 spacer group showed a significantly larger area directly fused to the endplate than the control group (P<0.001). The BGS-7 spacer group showed a significant increase in the fused area compared with the titanium group at 1- and 4-year follow-up. The ODI, SF-36, back pain, and lower limb pain in both groups showed significant improvement after surgery, and no significant differences were observed between the groups. Both groups showed no additional adverse events.
CONCLUSIONS


The 4-year follow-up study showed similar fusion rates and clinical outcomes in both the BGS-7 spacer and autologous bone with a titanium cage in 1-level PLIF. However, the BGS-7 spacer implants showed a larger area of fusion with the endplates than that of autologous bone with a titanium cage. Therefore, the results demonstrated that the BGS-7 spacer can be considered as a novel intervertebral spacer to achieve successful spinal fusion without safety concerns for long-term use.",2020,"The ODI, SF-36, back pain, and lower limb pain in both groups showed significant improvement after surgery, and no significant differences were observed between the groups.",['62 of the 74 patients who underwent 1-level PLIF'],"['CaO-SiO2-P2O5-B2O3 glass ceramics (BGS-7) spacers', 'plain radiography and thin-section computed tomography', 'CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramics (BGS-7) Intervertebral Spacer and Titanium Cage']","['ODI, SF-36, back pain, and lower limb pain', 'Bone fusion', 'Visual Analog Scale (VAS), the Oswestry Disability Index (ODI), Short Form-36 Health Survey (SF-36), and evaluation of safety', 'bone fusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C3712088', 'cui_str': 'CaO-SiO2-P2O5-B2O3 glass'}, {'cui': 'C0221874', 'cui_str': 'Spacer (physical object)'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0541042', 'cui_str': '(PMMA)-SiO2'}, {'cui': 'C0136917', 'cui_str': 'phosphoric anhydride'}, {'cui': 'C0164142', 'cui_str': 'boron oxide'}, {'cui': 'C1618088', 'cui_str': 'Glass ceramics'}, {'cui': 'C0442106', 'cui_str': 'Intervertebral (qualifier value)'}, {'cui': 'C0441240', 'cui_str': 'Titanium cage (physical object)'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0185364', 'cui_str': 'Repair or plastic operation on bone'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",74.0,0.0227135,"The ODI, SF-36, back pain, and lower limb pain in both groups showed significant improvement after surgery, and no significant differences were observed between the groups.","[{'ForeName': 'Jae Hyup', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine Seoul National University.'}, {'ForeName': 'Sun Ki', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center.'}, {'ForeName': 'Sung Shik', 'Initials': 'SS', 'LastName': 'Kang', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University Bundang Hospital.'}, {'ForeName': 'Seung Jung', 'Initials': 'SJ', 'LastName': 'Han', 'Affiliation': 'Department of Medical and Scientific Affairs, CGBio.'}, {'ForeName': 'Choon-Ki', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine Seoul National University.'}, {'ForeName': 'Bong-Soon', 'Initials': 'BS', 'LastName': 'Chang', 'Affiliation': 'Department of Orthopedic Surgery, College of Medicine Seoul National University.'}]",Clinical spine surgery,['10.1097/BSD.0000000000000950']
2976,31429601,The Depression Prevention Initiative: Mediators of Interpersonal Psychotherapy-Adolescent Skills Training.,"Several adolescent depression prevention programs have demonstrated effects on depressive symptoms and overall functioning. Yet, despite an increasing emphasis on elucidating mechanisms of change in interventions, few studies have identified mediators of these preventive interventions. In this study, we examined interpersonal mediators of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program. The Depression Prevention Initiative is a school-based randomized controlled trial in which 186 adolescents ( M  age = 14.01,  SD  = 1.22; 66.7% female; 32.2% racial minority) were assigned to receive either IPT-AST ( n  = 95) or Group Counseling (GC) ( n  = 91). We examined whether change in interpersonal conflict, social support, or social functioning from baseline to midintervention mediated the effects of IPT-AST on depressive symptoms and overall functioning at postintervention. At postintervention, youth in IPT-AST had lower depressive symptoms ( d  = -.31) and higher overall functioning scores ( d  = .32) than youth in GC. Improvements in adolescent romantic functioning, reductions in peer conflict, and improvements in a factor score reflecting mother-adolescent conflict and difficulties in family functioning emerged as significant mediators. However, the effects of the intervention on change in the mediators were not statistically significant. These findings add to the sparse literature on mediators of psychosocial interventions, provide partial support for the theoretical mechanisms underlying change in IPT-AST, and highlight important directions for future prevention and intervention research.",2019,"At postintervention, youth in IPT-AST had lower depressive symptoms ( d  = -.31) and higher overall functioning scores ( d  = .32) than youth in GC.","['186 adolescents ( M  age\xa0=\xa014.01,  SD\xa0 =\xa01.22; 66.7% female; 32.2% racial minority']","['IPT-AST', 'Interpersonal Psychotherapy-Adolescent Skills Training', 'Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST', 'IPT-AST ( n  =\xa095) or Group Counseling (GC']","['depressive symptoms', 'interpersonal conflict, social support, or social functioning', 'depressive symptoms and overall functioning', 'adolescent romantic functioning, reductions in peer conflict', 'overall functioning scores']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy (regime/therapy)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0037438'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",186.0,0.0381103,"At postintervention, youth in IPT-AST had lower depressive symptoms ( d  = -.31) and higher overall functioning scores ( d  = .32) than youth in GC.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, and PolicyLab Children's Hospital of Philadelphia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': 'Department of Mathematics, West Chester University.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Gillham', 'Affiliation': 'Department of Psychology, Swarthmore College.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mufson', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Farley', 'Affiliation': 'Department of Psychology, Rutgers University.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kanine', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, and PolicyLab Children's Hospital of Philadelphia.""}, {'ForeName': 'Jami F', 'Initials': 'JF', 'LastName': 'Young', 'Affiliation': ""Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, and PolicyLab Children's Hospital of Philadelphia.""}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1644648']
2977,32065303,Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial.,"The Vi polysaccharide typhoid fever vaccine (TFV) provides incomplete protection against typhoid fever. BCG, the vaccine against tuberculosis, can potentiate immune responses to other vaccines through induction of trained innate immunity and heterologous adaptive immunity. We performed an explorative, randomized, noncontrolled open trial to investigate whether BCG vaccination increases humoral and cellular response to TFV and whether BCG and TFV modulate nonspecific immune responses. Thirty volunteers were randomized to receive either TFV alone or BCG followed by TFV after 2 weeks. Ex vivo leukocyte responses and anti-Vi IgG antibody titers were measured 2 weeks and 3 months after TFV. BCG administration prior to TFV vaccination did not increase specific humoral or cellular immune responses to Salmonella typhi. TFV vaccination decreased pro-inflammatory responses to non-related stimuli. This effect was counteracted by prior BCG administration, which also led to decreased IL-10 and increased IL-22 responses to non-related stimuli. In an in vitro model of trained immunity TFV led to immunotolerance, which was partially reversed by BCG-induced trained immunity. BCG does not modulate adaptive immune responses to TFV but partially prevents inhibition of innate immune responses induced by TFV. Nonspecific effects of vaccines to unrelated microbial stimuli must be considered in the evaluation of their biological effects (ClinicalTrials.gov NCT02175420).",2020,"This effect was counteracted by prior BCG administration, which also led to decreased IL-10 and increased IL-22 responses to non-related stimuli.","['Thirty volunteers', 'vi polysaccharide typhoid fever vaccination']","['BCG', 'TFV alone or BCG', 'BCG vaccine', 'Vi polysaccharide typhoid fever vaccine (TFV', 'TFV vaccination', 'BCG vaccination']","['IL-10 and increased IL-22 responses', 'specific humoral or cellular immune responses', 'Ex vivo leukocyte responses and anti-Vi IgG antibody titers']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0961814', 'cui_str': 'interleukin-22'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",30.0,0.197746,"This effect was counteracted by prior BCG administration, which also led to decreased IL-10 and increased IL-22 responses to non-related stimuli.","[{'ForeName': 'Bastiaan A', 'Initials': 'BA', 'LastName': 'Blok', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Rob J W', 'Initials': 'RJW', 'LastName': 'Arts', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Aaby', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen, Denmark.'}, {'ForeName': 'Leo A B', 'Initials': 'LAB', 'LastName': 'Joosten', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Christine S', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, DK-2300, Copenhagen, Denmark.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Department of Internal Medicine and Radboud Center for Infectious Diseases (RCI), Radboud University Medical Center, 6526, GA, Nijmegen, The Netherlands. mihai.netea@radboudumc.nl.'}]",European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology,['10.1007/s10096-020-03813-y']
2978,32077951,Self-Reported Knee Pain Does Not Impact Physical Training Negatively in Conscripts.,"INTRODUCTION


Despite the great number of investigations on the effects of injuries during military service, there is limited information available on the use of self-reported instruments. This study evaluated self-reported knee pain (KP) and its effect on physical performance during military service in the Estonian Defense Forces.
MATERIAL AND METHODS


Ninety-five male conscripts aged 19-25 years were divided into two study groups based on the occurrence of KP or not. Self-reported KP and function according to the Knee Injury and Osteoarthritis Outcome Score (KOOS) were measured. Physical fitness level was scored using the Army Physical Fitness Test (APFT). KOOS and APFT were measured in the beginning and at the end of the 6-month period of military service.
RESULTS


Significant differences in favor of the group without KP (P < 0.001) were found for all subgroups of the KOOS. In spite of KP, the physical condition improved significantly (P < 0.001) in both study groups as measured with both the APFT test (22.2% increase) and running time (10.3% decrease).
CONCLUSION


In conclusion, self-reported KP and limited function according to KOOS did not hinder the improvement of physical condition and running speed as assessed by APFT in Estonian conscripts.",2020,"In spite of KP, the physical condition improved significantly (P < 0.001) in both study groups as measured with both the APFT test (22.2% increase) and running time (10.3% decrease).
",['Ninety-five male conscripts aged 19-25\xa0years'],[],"['running time', 'Knee Pain', 'Knee Injury and Osteoarthritis Outcome Score (KOOS', 'physical condition and running speed', 'KOOS and APFT', 'Physical fitness level']","[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",95.0,0.0258346,"In spite of KP, the physical condition improved significantly (P < 0.001) in both study groups as measured with both the APFT test (22.2% increase) and running time (10.3% decrease).
","[{'ForeName': 'Leho', 'Initials': 'L', 'LastName': 'Rips', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Madis', 'Initials': 'M', 'LastName': 'Rahu', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Rein', 'Initials': 'R', 'LastName': 'Kuik', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Ahti', 'Initials': 'A', 'LastName': 'Varblane', 'Affiliation': 'Estonian National Defence College, Centre of Military Disaster Medicine, Riia 12, Tartu 51010.'}, {'ForeName': 'Indrek', 'Initials': 'I', 'LastName': 'Olveti', 'Affiliation': 'Estonian National Defence College, Centre of Military Disaster Medicine, Riia 12, Tartu 51010.'}, {'ForeName': 'Vahur', 'Initials': 'V', 'LastName': 'Ööpik', 'Affiliation': 'Institute of Sports Science and Physiotherapy, University of Tartu, Ujula 4, Tartu 51008.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Mölder', 'Affiliation': 'Medical Centre of the 2nd Infantry Brigade CSS Battalion, Estonian Defence Forces, 3a Kose Road, Võru 65603.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Timpmann', 'Affiliation': 'Institute of Sports Science and Physiotherapy, University of Tartu, Ujula 4, Tartu 51008.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tammaru', 'Affiliation': 'East-Tallinn Central Hospital, Ravi st 18, Tallinn 10138.'}, {'ForeName': 'Alar', 'Initials': 'A', 'LastName': 'Toom', 'Affiliation': 'Department of Orthopaedics, Central Finland Central Hospital, Keskussairaalantie 19, Jyväskylä 40620.'}, {'ForeName': 'Jüri-Toomas', 'Initials': 'JT', 'LastName': 'Kartus', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gapeyeva', 'Affiliation': 'Institute of Sports Science and Physiotherapy, University of Tartu, Ujula 4, Tartu 51008.'}]",Military medicine,['10.1093/milmed/usz486']
2979,31375814,"A comparative assessment of orthodontic treatment outcomes using the quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques in adolescents: a single-centre, single-blind randomized controlled trial.","INTRODUCTION


The aim of this two-arm parallel trial was to evaluate enamel demineralization in fixed orthodontic treatment using an indirect bonding technique in comparison to a direct bonding technique by the quantitative light-induced fluorescence (QLF) method.
DESIGN, SETTINGS AND PARTICIPANTS


Fifty-six patients who needed fixed orthodontic treatment were randomly separated into either the direct bonding group or the indirect bonding group. The presence and extent of lesions on the buccal surfaces of all teeth, except the molar teeth, were assessed. The percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area) were determined using the system's software. The data were analysed with the Wilcoxon signed-rank and Mann-Whitney U-tests (P < 0.05).
INTERVENTIONS


Treatment with a direct bonding or an indirect bonding technique.
RESULTS


This study was completed with 25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years). In the indirect bonding technique, a few teeth (especially mandibular left canine: 50.45 ± 93.48; 95% confidence interval: -12.35 and 113.26) were found to develop significant white spot lesion (WSL) formation (P < 0.05). However, the number of teeth with demineralization was higher in the direct bonding group (P < 0.05).
CONCLUSION


The bonding procedures used in the indirect bonding technique contribute to reducing the degree of WSL formation. Further, the use of flowable composite adhesives in this bonding process is more effective at reducing the appearance of WSLs than in cases where conventional composite adhesives are used.
LIMITATIONS


The limitation of our trial may be the small sample size and the short follow-up time for the patients.
HARMS


No harms were detected during the study.
PROTOCOL


The protocol was not published before trial commencement.
REGISTRATION


This trial was registered post hoc at 'Clinical Trials' (http://www.clinicaltrials.gov), registration number (ID): NCT03738839.",2020,"However, the number of teeth with demineralization was higher in the direct bonding group (P < 0.05).
","['Fifty-six patients who needed fixed orthodontic treatment', 'adolescents', '25 patients in the indirect bonding group (12 females, 13 males; mean age: 15.42 ± 1.71 years) and 26 patients in the direct bonding group (12 females, 14 males; mean age: 14.73 ± 1.65 years']","['direct bonding or an indirect bonding technique', 'direct bonding group or the indirect bonding group', 'quantitative light-induced fluorescence (QLF) method between direct bonding and indirect bonding techniques']","['number of teeth with demineralization', 'percentage of fluorescence loss (ΔF and ΔFmax), the degree of demineralization (ΔQ) and lesion area (WS area', 'white spot lesion (WSL) formation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0700185', 'cui_str': 'Demineralized structure'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spot'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",56.0,0.0575289,"However, the number of teeth with demineralization was higher in the direct bonding group (P < 0.05).
","[{'ForeName': 'Aykan Onur', 'Initials': 'AO', 'LastName': 'Atilla', 'Affiliation': 'Osmanli Dental Center, Republic of Turkey Ministry of Health, Ankara.'}, {'ForeName': 'Taner', 'Initials': 'T', 'LastName': 'Ozturk', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Erciyes University, Kayseri.'}, {'ForeName': 'Mustafa Murat', 'Initials': 'MM', 'LastName': 'Eruz', 'Affiliation': 'Tesakademya Dental Clinic (Private Practice), Nevsehir, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Yagci', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Erciyes University, Kayseri.'}]",European journal of orthodontics,['10.1093/ejo/cjz058']
2980,32074247,An Appraisal of the Association of Clinical Outcomes With the Severity of Regurgitant Volume Relative to End-Diastolic Volume in Patients With Secondary Mitral Regurgitation.,"Importance


Two randomized clinical trials of transcatheter edge-to-edge mitral valve repair in patients with secondary mitral regurgitation (the Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR] and the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation [COAPT]) report clinical outcome disparities that are largely unexplained. This appraisal sought to provide insight and an explanation for the differences in clinical outcomes (survival and hospitalization rates) in the 2 clinical trials. The mean echocardiogram Doppler results (and derived volume parameters) from each of the 2 clinical trials were compared and examined relative to the clinical outcomes. Special emphasis was placed on the assessment of mitral regurgitation proportionality coefficients that were determined as the ratio of effective regurgitant orifice area (EROA) to end-diastolic volume and the ratio of mitral regurgitant volume to end-diastolic volume.
Observations


In this analysis of the differences in the clinical outcomes of the MITRA-FR and COAPT clinical trials, the ratio of the EROA to the end-diastolic volume in the COAPT study was found to be twice that of the MITRA-FR study (0.002 cm-1 vs 0.001 cm-1, respectively). The finding of a larger proportional EROA in the COAPT study suggests more severe mitral regurgitation compared with the MITRA-FR study, thereby providing a potential explanation for the different outcomes in the 2 clinical trials. In contrast, the ratio of the mitral regurgitant volume to the end-diastolic volume in the COAPT study was similar to (but slightly lower than) that of the MITRA-FR study (0.15 vs 0.18, respectively), indicating that the proportional mitral regurgitant volume was comparable in the 2 clinical trials. This finding contradicts the conclusions of the EROA analysis.
Conclusions and Relevance


The results of proportionality analyses based on EROA differ from those based on a volume analysis. This disparity casts doubt on the notion that an EROA analysis alone can explain the different results of the 2 randomized clinical trials.",2020,This disparity casts doubt on the notion that an EROA analysis alone can explain the different results of the 2 randomized clinical trials.,"['patients with secondary mitral regurgitation', 'Heart Failure Patients with Functional Mitral Regurgitation [COAPT', 'Patients With Secondary Mitral Regurgitation', 'Patients With Severe Secondary Mitral Regurgitation [MITRA-FR']","['MitraClip Percutaneous Therapy', 'transcatheter edge-to-edge mitral valve repair', 'Percutaneous Mitral Valve Repair MitraClip Device']","['ratio of effective regurgitant orifice area (EROA) to end-diastolic volume and the ratio of mitral regurgitant volume to end-diastolic volume', 'severe mitral regurgitation', 'mean echocardiogram Doppler results', 'ratio of the mitral regurgitant volume to the end-diastolic volume', 'proportional mitral regurgitant volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0340369', 'cui_str': 'Functional mitral regurgitation (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026266', 'cui_str': 'Mitral Incompetence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}]",,0.0310262,This disparity casts doubt on the notion that an EROA analysis alone can explain the different results of the 2 randomized clinical trials.,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Gaasch', 'Affiliation': 'Department of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Aurigemma', 'Affiliation': 'Department of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Theo E', 'Initials': 'TE', 'LastName': 'Meyer', 'Affiliation': 'Department of Cardiovascular Medicine, Lahey Hospital and Medical Center, Burlington, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.5980']
2981,31548616,Effect of self-initiated and fully-automated self-measurement on blood pressure.,"Self-measurement of blood pressure (BP) is regularly used to diagnose hypertension and to monitor BP at home. We recently showed that self-measurement of BP may elicit a pressor or 'auto-cuff' response. In this study we examined whether the pressor response is different between self-initiated and fully-automated BP measurement. We performed two randomized crossover studies in outpatients visiting a hypertension clinic. The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography. The second cohort consisted of 120 patients who performed three self-initiated and three fully-automated BP measurements. In the first cohort (mean age 61.2 ± 10.4 years, mean office BP 142.0 ± 19.9/82.5 ± 12.2 mmHg, 36.7% female) average systolic and diastolic BP increased by 7.3 ± 8.5/3.3 ± 4.0 mmHg in the group with self-initiated BP measurements, while BP increased by 3.3 ± 6.3/1.4 ± 3.0 mmHg during fully-automated measurements (p = 0.002/p = 0.002 for difference between groups). The higher BP increase during self-initiated BP measurements resulted from an increase in heart rate and cardiac output. In the second cohort (mean age 58.0 ± 14.1 years, mean office BP 153.6 ± 23.8/86.3 ± 14.0 mmHg, 44.1% female) self-initiated BP measurement resulted in a 2.1 ± 6.8/0.9 ± 4.0 mmHg higher systolic and diastolic BP compared with fully-automated self-measurement (p = 0.001/0.018). In conclusion, our findings suggest that self-initiated BP measurement using a fully-automated method results in a more reliable BP compared with a self-initiated semi-automated method by attenuating the auto-cuff response. These findings may have implications for the self-measurement of BP.",2020,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","['outpatients visiting a hypertension clinic', '120 patients who performed three self-initiated and three fully-automated BP measurements', 'In the second cohort (mean age 58.0\u2009±\u200914.1 years, mean office BP 153.6\u2009±\u200923.8/86.3\u2009±\u200914.0\u2009mmHg, 44.1% female']",['self-initiated and fully-automated self-measurement'],"['blood pressure', 'systolic and diastolic BP', 'heart rate and cardiac output', 'pressor response', 'self-initiated BP measurement', 'Self-measurement of blood pressure (BP']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.024403,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","[{'ForeName': 'Rosanne T', 'Initials': 'RT', 'LastName': 'Berkhof', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gazzola', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands. b.j.vandenborn@amsterdamumc.nl.'}]",Journal of human hypertension,['10.1038/s41371-019-0256-1']
2982,32076866,Effect of different concentrations of commercially available mouthwashes on wound healing following periodontal surgery: a randomized controlled clinical trial.,"OBJECTIVES


The purpose of this study was to evaluate the effect of chlorhexidine and essential oils containing mouth rinses on oral wound healing after periodontal flap surgery.
MATERIALS AND METHODS


Eighty subjects participated in the study and were randomly assigned to use water, 0.12% chlorhexidine (CHX), essential oils (EO), 5% CHX, and 10% EO. Subjects were examined at 1, 2, and 3 weeks postoperatively. Plaque index (PI) and the modified gingival index (GI) were recorded, while wound epithelialization was measured to evaluate the healing process. Numerical data were analyzed with parametric test for multiple comparisons (ANOVA) with Bonferroni correction. Categorical data were analyzed using Chi-square test/fisher exact test.
RESULTS


All groups demonstrated a gradual GI reduction from first to third visit. Patients in the CHX group presented statistically significant lower PI scores than patients in the water group at the all-time points of the study. Wound epithelialization analysis demonstrated that 100% of the sites in the CHX group were healing by secondary intention at visit 1. This finding was statistically significant.
CONCLUSION


Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
CLINICAL RELEVANCE


The use of chlorhexidine and EO containing mouthwashes does not appear to delay wound healing. Diluting these commercial mouthwashes may present an approach that could possibly reduce the adverse effects (such as tooth staining) associated with their use, while maintaining their antibacterial properties.",2020,"Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
","['periodontal surgery', 'Eighty subjects participated in the study and were randomly assigned to use water, 0.12']","['chlorhexidine and essential oils containing mouth rinses', 'CHX', 'chlorhexidine (CHX), essential oils (EO), 5% CHX, and 10% EO', 'chlorhexidine and EO containing mouthwashes']","['PI scores', 'adverse effects', 'Wound epithelialization analysis', 'wound epithelialization', 'delay wound healing', 'Plaque index (PI) and the modified gingival index (GI', 'gradual GI reduction', 'oral wound healing', 'wound healing']","[{'cui': 'C0398950', 'cui_str': 'Periodontal operation (procedure)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4517426', 'cui_str': '0.12 (qualifier value)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3266038', 'cui_str': 'Wound Epithelialization'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0439833', 'cui_str': 'Gradual (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",80.0,0.0616574,"Full strength concentrations of CHX and EO did not show any detrimental effects on healing after traditional periodontal surgery at the end of the observation period.
","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Katsaros', 'Affiliation': 'Department of Periodontics, University of Iowa College of Dentistry and Dental Clinics, 801 Newton Rd., S447, Iowa City, IA, 52241, USA. theodoros-katsaros@uiowa.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mayer', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}, {'ForeName': 'Archontia', 'Initials': 'A', 'LastName': 'Palaiologou', 'Affiliation': 'Department of Periodontics, UT Health San Antonio School of Dentistry, San Antonio, TX, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Romero-Bustillos', 'Affiliation': 'Department of Periodontics, University of Iowa College of Dentistry and Dental Clinics, 801 Newton Rd., S447, Iowa City, IA, 52241, USA.'}, {'ForeName': 'Gerald H', 'Initials': 'GH', 'LastName': 'Evans', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Lallier', 'Affiliation': 'Department of Cell Biology and Anatomy, Louisiana State University Health Sciences Center, New Orleans, LA, 70119, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Maney', 'Affiliation': 'Department of Periodontics, Louisiana State University Health Sciences Center School of Dentistry, New Orleans, LA, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03232-5']
2983,32078078,Then We Looked at His Results: Men Who Have Sex With Men from New York City and Puerto Rico Report Their Sexual Partner's Reactions to Receiving Reactive HIV Self-Test Results.,"Secondary distribution of HIV self-tests to sexual partners is acceptable but concerns remain about reactions if a partner tests HIV-positive. We report on 14 participants whose sexual partners tested HIV-positive during the ""I'll Show You Mine"" Study, a randomized controlled trial (N = 272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW). All 14 were MSM and racial/ethnic minorities, mean age was 36.6 years; 86% were gay-identified. Twenty-four partners tested positive; about half were new partners. Six participants had multiple partners test positive. During in-depth interviews with 10 of these participants, they reported their partners' reactions ranged from tearful and worried among those whose result was unexpected, to resignation among those who suspected a positive result, to nonchalance among partners who participants concluded knew of their HIV infection. After testing, some HIV-positive partners disclosed prior knowledge of their status. No partner reacted violently. Participants typically comforted their partners and encouraged confirmatory testing. Four participants had anal intercourse with partners who tested positive. Participants and partners were able to effectively handle situations in which the partner tested HIV-positive.",2020,No partner reacted violently.,"['Six participants had multiple partners test positive', 'All 14 were MSM and racial/ethnic minorities, mean age was 36.6\xa0years; 86% were gay-identified', 'Participants typically comforted their partners and encouraged confirmatory testing', 'Four participants had anal intercourse with partners who tested positive', '14 participants whose sexual partners tested HIV-positive during the ""I\'ll Show You Mine"" Study, a randomized controlled trial (N\u2009=\u2009272) of HIV self- and partner-testing among men who have sex with men (MSM) and transgender women (TGW']",[],['knew of their HIV infection'],"[{'cui': 'C0026767', 'cui_str': 'Multiple Partners'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]",[],"[{'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}]",14.0,0.0277884,No partner reacted violently.,"[{'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. ivan.balan@nyspi.columbia.edu.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tagliaferri Rael', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02816-2']
2984,32071058,Assessment of Drug Resistance during Phase 2b Clinical Trials of Presatovir in Adults Naturally Infected with Respiratory Syncytial Virus.,"This study summarizes drug resistance analyses in 4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults. Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection were enrolled in 4 randomized, double-blind, placebo-controlled studies with study-specific presatovir dosing. Full-length RSV  F  sequences amplified from nasal swabs obtained at baseline and postbaseline were analyzed by population sequencing. Substitutions at RSV fusion inhibitor resistance-associated positions are reported. Genotypic analyses were performed on 233 presatovir-treated and 149 placebo-treated subjects. RSV F variant V127A was present in 8 subjects at baseline. Population sequencing detected treatment-emergent substitutions in 10/89 (11.2%) HCT recipients with upper and 6/29 (20.7%) with lower respiratory tract infection, 1/35 (2.9%) lung transplant recipients, and 1/80 (1.3%) hospitalized patients treated with presatovir; placebo-treated subjects had no emergent resistance-associated substitutions. Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but they had similar clinical outcomes. Subject population type and dosing regimen may have influenced RSV resistance development during presatovir treatment. Subjects with genotypic resistance development had decreased virologic responses compared to those without genotypic resistance but had comparable clinical outcomes.",2020,"Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.","['4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults', 'adults naturally infected with respiratory syncytial virus', 'Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection']","['placebo', 'presatovir; placebo']","['virologic responses', 'RSV resistance development', 'emergent resistance-associated substitutions', 'viral load']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1275666', 'cui_str': 'Fusion inhibitor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",233.0,0.226378,"Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Porter', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA Danielle.Porter@gilead.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gossage', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Watkins', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Chien', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02312-19']
2985,31375051,Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study.,"Objective:  To evaluate the efficacy and safety of dasotraline for treatment of ADHD in children.  Method:  Children (ages 6-12 years;  N  = 112) with ADHD were randomized, double-blind, to 14 days of once-daily evening doses of dasotraline 4 mg or placebo. ADHD symptom severity was measured at baseline and Day 15 in seven, 30-min classroom sessions using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and the Permanent Product Measure of Performance (PERMP) math test.  Results:  Significant improvement was observed for dasotraline versus placebo in the SKAMP-combined score (-3.2 vs. +2.0;  p  < .001; effect size = 0.85) and SKAMP and PERMP subscale scores. The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%).  Conclusion:  In this laboratory classroom study, dasotraline 4 mg was found to be an efficacious and generally well-tolerated treatment for ADHD in children aged 6 to 12 years.",2020,"The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%).  ","['children', 'Children With ADHD', 'children aged 6 to 12 years', 'Method:  Children (ages 6-12 years', 'N  = 112) with ADHD']","['dasotraline', 'Dasotraline', 'placebo', 'dasotraline 4 mg or placebo']","['headache', 'ADHD symptom severity', 'SKAMP and PERMP subscale scores', 'efficacy and safety', 'Efficacy and Safety', 'insomnia', 'appetite']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C4276542', 'cui_str': '4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydronaphthalen-1-amine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",,0.275235,"The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%).  ","[{'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Wigal', 'Affiliation': 'AVIDA Inc., Newport Beach, CA, USA.'}, {'ForeName': 'Seth C', 'Initials': 'SC', 'LastName': 'Hopkins', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Koblan', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.'}, {'ForeName': 'Justine M', 'Initials': 'JM', 'LastName': 'Kent', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Tsai', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hsu', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",Journal of attention disorders,['10.1177/1087054719864644']
2986,29979275,Potentiating Response to Drop-Jump Protocols on Sprint Acceleration: Drop-Jump Volume and Intrarepetition Recovery Duration.,"Byrne, PJ, Moody, JA, Cooper, SM, Callanan, D, and Kinsella, S. Potentiating response to drop-jump protocols on sprint acceleration: drop-jump volume and intrarepetition recovery duration. J Strength Cond Res 34(3): 717-727, 2020-The purpose of this study was to investigate the postactivation potentiation response first to bounce drop jump (BDJ) volume; second, BDJ intrarepetition recovery duration and recovery duration between BDJs and 20-meter (including 5- and 10-m split times) sprint performance. The study was undertaken in 2 parts, the first part compared different volumes of BDJs and the second part compared different BDJ intrarepetition recovery periods. The effect of recovery periods between the BDJs and the subsequent 20-m sprints was examined in both parts 1 and 2 (15 seconds, 4, 8, and 12 minutes). Fourteen (mean ± SD: age = 20.83 ± 1.26 years; height = 1.77 ± 0.04 m; and mass = 74.89 ± 6.07 kg) (part 1) and 15 (mean ± SD: age = 20.64 ± 1.00 years; height = 1.78 ± 0.06 m; and mass = 75.67 ± 6.28 kg) (part 2) male collegiate and club hurling players volunteered to participate. A randomized cross-over design was used to compare BDJ volumes (1, 2, and 3 sets of 3 repetitions) and BDJ intrarepetition recovery time (15 vs. 60 seconds) after a warm-up followed by 2 baseline 20-m sprints. The results in part 1 reported a significant improvement in 5- and 10-m sprint time for 1 set of 3 BDJs between baseline and 4 minutes (5 m: -2.34%, p = 0.04, effect size [ES] = -0.043; 10 m: -1.42%, p = 0.03, ES = -0.35), and baseline and 12 minutes (5 m: -3.33%, p = 0.03, ES = -0.57; 10 m: -2.13%, p = 0.01, ES = -0.52). Part 2 reported a significant improvement in 5-m sprint time between baseline and 15 seconds (5 m: -3.38%, p = 0.01, ES = -0.83; 10 m: -2.07%, p = 0.02, ES = -0.58) after the BDJs. The findings support the use of 1 set of 3 BDJs using a 15-second intrarepetition recovery period to maximize 5-, 10-, and 20-m sprint performance after 15 seconds of recovery after the final BDJ in hurling players. The acute response to this BDJ protocol proves to be time efficient and effective in acutely improving sprint acceleration.",2020,"The results in part 1 reported a significant improvement in 5- and 10-m sprint time for 1 set of 3 BDJs between baseline and 4 minutes (5 m: -2.34%, p = 0.04, effect size [ES] = -0.043; 10 m: -1.42%, p = 0.03, ES = -0.35), and baseline and 12 minutes (5 m: -3.33%, p = 0.03, ES = -0.57; 10 m: -2.13%, p = 0.01, ES = -0.52).","['mean ± SD: age = 20.64 ± 1.00 years; height = 1.78 ± 0.06 m; and mass = 75.67 ± 6.28 kg) (part 2', 'male collegiate and club hurling players volunteered to participate', 'Fourteen', 'mean ± SD: age = 20.83 ± 1.26 years; height = 1.77 ± 0.04 m; and mass = 74.89 ± 6.07 kg']",['J Strength Cond Res XX(X'],"['5-m sprint time', 'split times) sprint performance', '5- and 10-m sprint time', 'postactivation potentiation response first to bounce drop jump (BDJ) volume; second, BDJ intrarepetition recovery duration and recovery duration between BDJs and 20-meter (including 5- and 10-m', 'Byrne, PJ, Moody, JA, Cooper, SM, Callanan, D, and Kinsella, S. Potentiating response', 'BDJ intrarepetition recovery time']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517412', 'cui_str': 'Zero point zero six'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4517498', 'cui_str': 'One point two six'}, {'cui': 'C4517407', 'cui_str': 'Zero point zero four'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0554980', 'cui_str': 'Moody (finding)'}, {'cui': 'C0335912', 'cui_str': 'Cooper (occupation)'}]",,0.0362182,"The results in part 1 reported a significant improvement in 5- and 10-m sprint time for 1 set of 3 BDJs between baseline and 4 minutes (5 m: -2.34%, p = 0.04, effect size [ES] = -0.043; 10 m: -1.42%, p = 0.03, ES = -0.35), and baseline and 12 minutes (5 m: -3.33%, p = 0.03, ES = -0.57; 10 m: -2.13%, p = 0.01, ES = -0.52).","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Byrne', 'Affiliation': 'Department of Science and Health, Institute of Technology Carlow, Carlow, Ireland.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Moody', 'Affiliation': 'Cardiff School of Sport and Health Sciences (Sport), Cardiff Metropolitan University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Stephen-Mark', 'Initials': 'SM', 'LastName': 'Cooper', 'Affiliation': 'Cardiff School of Sport and Health Sciences (Sport), Cardiff Metropolitan University, Cardiff, Wales, United Kingdom.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Callanan', 'Affiliation': 'Department of Science and Health, Institute of Technology Carlow, Carlow, Ireland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Kinsella', 'Affiliation': 'Department of Science and Health, Institute of Technology Carlow, Carlow, Ireland.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002720']
2987,30063556,"Effects of Traditional and Vascular Restricted Strength Training Program With Equalized Volume on Isometric and Dynamic Strength, Muscle Thickness, Electromyographic Activity, and Endothelial Function Adaptations in Young Adults.","Ramis, TR, Muller, CHdL, Boeno, FP, Teixeira, BC, Rech, A, Pompermayer, MG, Medeiros, NdS, Oliveira, ÁRd, Pinto, RS, and Ribeiro, JL. Effects of traditional and vascular restricted strength training program with equalized volume on isometric and dynamic strength, muscle thickness, electromyographic activity, and endothelial function adaptations in young adults. J Strength Cond Res 34(3): 689-698, 2020-The purpose of the study was to evaluate and compare the acute and chronic effects of partial vascular occlusion training in young, physically active adults. Neuromuscular, morphological, and endothelial function responses were compared between high-intensity resistance training (HI-RT) and low-intensity resistance training with partial vascular occlusion (LI-BFR), despite the same training volume. The 28 subjects (age, 23.96 ± 2.67 years) were randomly assigned into 2 groups: LI-BFR (n = 15) and HI-RT (n = 13). Both groups performed unilateral exercise of elbow flexion (EF) and knee extension (KE) 3 times per week for 8 weeks. This study was approved by the ethics committee. Flow-mediated dilation showed a significant difference in baseline and post-training in the LI-BFR group (4.44 ± 0.51 vs. 6.35 ± 2.08 mm, respectively). For nitrite/nitrate concentrations only, there was a significant difference when comparing pre- and post-acute exercise in both groups. The torque and rep. Sixty percent 1 repetition maximum had improvements in both groups. There were differences between groups only in isometric delta EF and isokinetic delta KE (EF 3.42 ± 5.09 and 9.61 ± 7.52 N·m; KE 12.78 ± 25.61 and 42.69 ± 35.68 N·m; LI-BFR and HI-RT groups, respectively). There was a significant increase of muscle thickness in both groups. An increase of both isokinetic and isometric electromyography (EMG) of biceps of the HI-RT group was observed. The same was observed for the LI-BFR group regarding isokinetic and isometric EMG of vastus lateralis. Thus, in addition to strength and hypertrophy gains, this study also shows benefits related to vascular function. For practical applications, this study demonstrates a clinical importance of LI-BFR training as an alternative methodology.",2020,An increase of both isokinetic and isometric electromyography (EMG) of biceps of the HI-RT group was observed.,"['28 subjects (age, 23.96 ± 2.67 years', 'young, physically active adults', 'Young Adults', 'young adults']","['partial vascular occlusion training', 'J Strength Cond Res XX(X', 'traditional and vascular restricted strength training program', 'Traditional and Vascular Restricted Strength Training Program', 'unilateral exercise of elbow flexion (EF) and knee extension (KE', 'LI-BFR', 'high-intensity resistance training (HI-RT) and low-intensity resistance training with partial vascular occlusion (LI-BFR', 'LI-BFR training']","['isometric delta EF and isokinetic delta KE', 'Isometric and Dynamic Strength, Muscle Thickness, Electromyographic Activity, and Endothelial Function Adaptations', 'muscle thickness', 'Neuromuscular, morphological, and endothelial function responses', 'Flow-mediated dilation', 'isokinetic and isometric electromyography (EMG', 'Ramis, TR, Muller, CHdL, Boeno, FP, Teixeira, BC, Rech, A, Pompermayer, MG, Medeiros, NdS, Oliveira, ÁRd, Pinto, RS, and Ribeiro, JL', 'isometric and dynamic strength, muscle thickness, electromyographic activity, and endothelial function adaptations']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}]","[{'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0057753', 'cui_str': 'NDS'}, {'cui': 'C0324179', 'cui_str': 'Pinto (organism)'}]",,0.0203068,An increase of both isokinetic and isometric electromyography (EMG) of biceps of the HI-RT group was observed.,"[{'ForeName': 'Thiago Rozales', 'Initials': 'TR', 'LastName': 'Ramis', 'Affiliation': 'IPA Methodist University Center, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Carlos Henrique de Lemos', 'Initials': 'CHL', 'LastName': 'Muller', 'Affiliation': 'IPA Methodist University Center, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Francesco Pinto', 'Initials': 'FP', 'LastName': 'Boeno', 'Affiliation': 'IPA Methodist University Center, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Bruno Costa', 'Initials': 'BC', 'LastName': 'Teixeira', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Marcelo Gava', 'Initials': 'MG', 'LastName': 'Pompermayer', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Niara da Silva', 'Initials': 'NDS', 'LastName': 'Medeiros', 'Affiliation': 'IPA Methodist University Center, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Álvaro Reischak de', 'Initials': 'ÁR', 'LastName': 'Oliveira', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Ronei Silveira', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Jerri Luiz', 'Initials': 'JL', 'LastName': 'Ribeiro', 'Affiliation': 'IPA Methodist University Center, Porto Alegre, Rio Grande do Sul, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002717']
2988,31858429,Analysis of Japanese patients from the AUGMENT phase III study of lenalidomide + rituximab (R 2 ) vs. rituximab + placebo in relapsed/refractory indolent non-Hodgkin lymphoma.,"Patients with indolent non-Hodgkin lymphoma (iNHL) typically respond to first-line immunochemotherapy, but relapse is common. Treatment options for relapsed iNHL include chemotherapy ± rituximab and rituximab monotherapy. Lenalidomide plus rituximab (R 2 ) is an immunomodulatory regimen that enhances rituximab-mediated cytotoxicity and improves clinical activity in iNHL. AUGMENT was a double-blind phase III randomized trial of R 2  vs. rituximab + placebo (R-placebo) in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma who were not refractory to rituximab. The primary endpoint was progression-free survival (PFS). Data reported here focus on Japanese patients from AUGMENT and reflect 36 patients (n = 18, each group). PFS was superior in the R 2  group, HR = 0.32 (95% CI 0.11-0.96). Median PFS was not reached (95% CI 19.7-NE) in the R 2  group vs. 16.5 months (95% CI 11.3-30.6) in the R-placebo group. Grade 3/4 adverse events were more frequent in patients treated with R 2  (67%) than with R-placebo (22%), primarily attributable to increased neutropenia (50% vs 17%). R 2  resulted in significantly longer median PFS than R-placebo in Japanese patients with R/R iNHL, and the efficacy and the safety profile of R 2  were similar to those reported in the global population.",2020,"PFS was superior in the R 2  group, HR = 0.32 (95% CI 0.11-0.96).","['Patients with indolent non-Hodgkin lymphoma (iNHL', 'relapsed/refractory indolent non-Hodgkin lymphoma', 'Japanese patients', 'patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma who were not refractory to rituximab']","['placebo', 'lenalidomide\u2009+\u2009rituximab (R 2 ) vs. rituximab\u2009+\u2009placebo', 'Lenalidomide plus rituximab', 'rituximab and rituximab monotherapy', 'rituximab\u2009+\u2009placebo (R-placebo']","['PFS', 'progression-free survival (PFS', 'Grade 3/4 adverse events', 'neutropenia', 'median PFS', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024305', 'cui_str': ""Lymphoma, Nonhodgkin's""}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C1367654', 'cui_str': 'Marginal zone lymphoma'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",36.0,0.230906,"PFS was superior in the R 2  group, HR = 0.32 (95% CI 0.11-0.96).","[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Izutsu', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, 5-1-1 Tsukji, Chou-ku, Tokyo, 104-0045, Japan. kizutsu@ncc.go.jp.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Minami', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Terui', 'Affiliation': 'Department of Hematology Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Jo', 'Affiliation': 'Department of Hematology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Hematology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Kobe City Medical Center General Hospital, Hematology, Kobe, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kiguchi', 'Affiliation': 'Department of Hematology, Chugoku Central Hospital, Fukuyama, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Nagai', 'Affiliation': 'Department of Hematology and Oncology Research, Nagoya Medical Center, Clinical Research Center, Nagoya, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Ohtsu', 'Affiliation': 'Celgene K.K., Tokyo, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Kalambakas', 'Affiliation': 'Celgene Corporation, Summit, NJ, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Fustier', 'Affiliation': 'Celgene Corporation, Boudry, Switzerland.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Midorikawa', 'Affiliation': 'Celgene K.K., Tokyo, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, 5-1-1 Tsukji, Chou-ku, Tokyo, 104-0045, Japan.'}]",International journal of hematology,['10.1007/s12185-019-02802-y']
2989,32071431,Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.,"We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care ""watch and wait"" for these patients.",2020,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","['Two hundred and one patients with ≥2 risk features were classified as high-risk CLL', 'patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL', 'Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10\u2009U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12', 'patients with an early-stage high-risk chronic lymphocytic leukemia (CLL']","['immediate therapy with 6xFCR', 'fludarabine, cyclophosphamide, and rituximab (FCR', 'FCR']","['hematological toxicities and infections', 'overall survival benefit', 'overall response rate', 'event-free survival']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040078', 'cui_str': 'Deoxythymidine Kinase'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0432408', 'cui_str': 'Trisomy 12 (disorder)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",800.0,0.142644,"There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864).","[{'ForeName': 'Carmen D', 'Initials': 'CD', 'LastName': 'Herling', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany. carmen.herling@uk-koeln.de.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Groß-Ophoff-Müller', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Bahlo', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Robrecht', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Langerbeins', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Fink', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Othman', 'Initials': 'O', 'LastName': 'Al-Sawaf', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Raymonde', 'Initials': 'R', 'LastName': 'Busch', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University, Munich, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Porcher', 'Affiliation': 'Center of Clinical Epidemiology, Hopital Hotel-Dieu, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cazin', 'Affiliation': 'Service de Maladies du Sang, CHU Claude Huriez, Lille Cedex, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreyfus', 'Affiliation': ""Service d'Hematologie, CHU Poitiers, Poitiers, France.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ibach', 'Affiliation': 'WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Leprêtre', 'Affiliation': 'Inserm Unit U1245 and Department of Hematology, Cancer Centre Henri Becquerel and Normandie University Rouen, Rouen, France.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Day Clinic Hematology Oncology Palliative Care, Landshut, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Clemens-Martin', 'Initials': 'CM', 'LastName': 'Wentner', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Manuela A', 'Initials': 'MA', 'LastName': 'Hoechstetter', 'Affiliation': 'Department of Hematology Oncology, Immunology, Palliative Medicine, Infectious Diseases and Tropical Medicine, Klinikum Schwabing, Munich, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Leblond', 'Affiliation': 'Department of Haematology, Hopital de la Pitie-Salpetriere, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kneba', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Letestu', 'Affiliation': ""Hopital Avicenne, Assistance Publique-Hopitaux de Paris (AP-HP), Service d'Hematologie Biologique, Bobigny, France.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Böttcher', 'Affiliation': 'Second Department of Medicine, University of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department of Internal Medicine III, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and Center of Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Levy', 'Affiliation': 'Unite de Recherche Clinique, Hopital Avicenne, Bobigny, France.'}]",Leukemia,['10.1038/s41375-020-0747-7']
2990,32069742,Contrasting short-term temperature effects on the profiling of metabolic and stress hormones in non-obese healthy adults: A randomized cross-over trial.,"The manifestation of elevated and sustained air temperature gradient profiles in urban dwellings represents an emerging planetary health phenomenon. There is currently limited evidence about the effect of elevated air temperatures on metabolic health. The aim of this work was to assess changes in metabolic and stress hormonal profiles during a short-term stay in a mountainous, climate-cooler setting against those observed in the urban setting. A prospective, randomized, 2 x 2 cross-over trial of non-obese healthy adults in urban and mountainous areas of a Mediterranean country (Cyprus) was set up during summer, under real-life conditions. The intervention was a short-term stay (mean ± SD: 7 ± 3 days) in a mountainous, climate-cooler setting (altitude range: 650-1200 m), being ~1-h drive away from the main urban centres of Cyprus. The primary endpoint was the change in metabolic hormones levels (leptin and adiponectin) and stress hormone levels (cortisol) between the two settings. Personal air and skin temperature sensors were deployed while biospecimen were collected in each setting. A total of 41 participants between 20 and 60 years old were enrolled and randomized during July 2018, of whom 39 received the allocated intervention, 8 were lost to follow up or excluded from analysis and a total of 31 participants were analysed. A significant leptin reduction (β = -0.255; 95% CI: -0.472, -0.038; p = 0.024) was observed for non-obese healthy adults during their short-term stay in the mountainous environment. The intervention effect on adiponectin or cortisol levels was not statistically significant (β = 0.058; 95% CI: -0.237, 0.353; p = 0.702), and (β = -0.026; 95% CI: -0.530, 0.478; p = 0.920), respectively. In additional analyses, daily max skin temperature surrogate measures were significantly associated with leptin levels (β = 0.34; 95% CI: 0.051, 0.633; p = 0.024). During summer season, a short-term stay in climatologically cooler areas improved the leptin levels of non-obese healthy adults who permanently reside in urban areas of a Mediterranean country. A larger sample is needed to confirm the trial findings that could provide the rationale for such public health interventions in climate-impacted urban areas of our planet.",2020,"The intervention effect on adiponectin or cortisol levels was not statistically significant (β = 0.058; 95% CI: -0.237, 0.353; p = 0.702), and (β = -0.026; 95% CI: -0.530, 0.478; p = 0.920), respectively.","['non-obese healthy adults', 'urban dwellings', 'non-obese healthy adults who permanently reside in urban areas of a Mediterranean country', '41 participants between 20 and 60 years old were enrolled and randomized during July 2018, of whom 39 received the allocated intervention, 8 were lost to follow up or excluded from analysis and a total of 31 participants were analysed', 'non-obese healthy adults in urban and mountainous areas of a Mediterranean country (Cyprus) was set up during summer, under real-life conditions']",[],"['adiponectin or cortisol levels', 'leptin reduction', 'Personal air and skin temperature sensors', 'daily max skin temperature surrogate measures', 'metabolic and stress hormonal profiles', 'leptin levels', 'change in metabolic hormones levels (leptin and adiponectin) and stress hormone levels (cortisol']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],"[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",41.0,0.0881305,"The intervention effect on adiponectin or cortisol levels was not statistically significant (β = 0.058; 95% CI: -0.237, 0.353; p = 0.702), and (β = -0.026; 95% CI: -0.530, 0.478; p = 0.920), respectively.","[{'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Makris', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus. Electronic address: konstantinos.makris@cut.ac.cy.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Konstantinou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Perikkou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Zdravic', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Costas A', 'Initials': 'CA', 'LastName': 'Christophi', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}]",Environmental research,['10.1016/j.envres.2019.109065']
2991,32012434,Brief O 2  uploading during continuous hypothermic machine perfusion is simple yet effective oxygenation method to improve initial kidney function in a porcine autotransplant model.,"With oxygenation proposed as a resuscitative measure during hypothermic models of preservation, the aim of this study was to evaluate the optimal start time of oxygenation during continuous hypothermic machine perfusion (HMP). In this porcine ischemia-reperfusion autotransplant model, the left kidney of a ±40 kg pig was exposed to 30 minutes of warm ischemia prior to 22 hours of HMP and autotransplantation. Kidneys were randomized to receive 2 hours of oxygenation during HMP either at the start (n = 6), or end of the perfusion (n = 5) and outcomes were compared to standard, nonoxygenated HMP (n = 6) and continuous oxygenated HMP (n = 8). The brief initial and continuous oxygenated HMP groups were associated with superior graft recovery compared to either standard, nonoxygenated HMP or kidneys oxygenated at the end of HMP. This correlated with significant metabolic differences in perfusate (eg, lactate, succinate, flavin mononucleotide) and tissues (eg, succinate, adenosine triphosphate, hypoxia-inducible factor-1α, nuclear factor erythroid 2-related factor 2) suggesting superior mitochondrial preservation with initial oxygenation. Brief initial O 2  uploading during HMP at procurement site might be an easy and effective preservation strategy to maintain aerobic metabolism, protect mitochondria, and achieve an improved early renal graft function compared with standard HMP or oxygen supply shortly at the end of HMP preservation.",2020,"The brief initial and continuous oxygenated HMP groups were associated with superior graft recovery compared to either standard, non-oxygenated HMP or kidneys oxygenated at the end of HMP.",[],"['standard, non-oxygenated HMP (n=6) and continuous oxygenated HMP']","['metabolic differences in perfusate (e.g. lactate, succinate, flavin mononucleotide) and tissues (e.g. succinate, ATP, HIF-1α, Nrf2', 'initial kidney function', 'superior graft recovery']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C0016388', 'cui_str': 'riboflavin mononucleotide'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]",,0.0203622,"The brief initial and continuous oxygenated HMP groups were associated with superior graft recovery compared to either standard, non-oxygenated HMP or kidneys oxygenated at the end of HMP.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Darius', 'Affiliation': 'Surgery and Abdominal Transplant Unit, University Clinics Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Vergauwen', 'Affiliation': 'Pole de Chirurgie Expérimentale et Transplantation, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'The Institute of Metabolism and Systems Research (IMSR), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gerin', 'Affiliation': 'Walloon Excellence in Lifesciences and Biotechnology (WELBIO), Laboratory of Physiological Chemistry, de Duve Institute, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Joris', 'Affiliation': 'Pole of Pharmacology and Therapeutics, Experimental and Clinical Research Institute, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Department of Surgery and Transplantation, Swiss HPB Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Aydin', 'Affiliation': 'Department of Pathology, University Clinics Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Muller', 'Affiliation': 'Department of Surgery and Transplantation, Swiss HPB Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schlegel', 'Affiliation': 'Liver Unit, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Nath', 'Affiliation': 'Department of Renal Transplantation, Southmead Hospital Bristol, Bristol, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ludwig', 'Affiliation': 'The Institute of Metabolism and Systems Research (IMSR), University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Dessy', 'Affiliation': 'Pole of Pharmacology and Therapeutics, Experimental and Clinical Research Institute, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Many', 'Affiliation': 'Department of Morphology, Experimental and Clinical Research Institute, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Bommer', 'Affiliation': 'Walloon Excellence in Lifesciences and Biotechnology (WELBIO), Laboratory of Physiological Chemistry, de Duve Institute, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Dutkowski', 'Affiliation': 'Department of Surgery and Transplantation, Swiss HPB Center, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gianello', 'Affiliation': 'Pole de Chirurgie Expérimentale et Transplantation, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Mourad', 'Affiliation': 'Surgery and Abdominal Transplant Unit, University Clinics Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15800']
2992,31520838,Do Baseline Asthma and Allergic Sensitization Characteristics Predict Responsiveness to Mouse Allergen Reduction?,"BACKGROUND


Mouse allergen reduction is associated with improvements in asthma among sensitized and exposed children, but whether clinical characteristics predict responsiveness to allergen reduction is unclear.
OBJECTIVE


To examine the effects of clinical characteristics on relationships between mouse allergen reduction and asthma outcomes.
METHODS


We performed a secondary analysis of data from a randomized clinical trial of a mouse allergen intervention, examining the effects of atopy, demographic characteristics, lung function, asthma control, and asthma severity on relationships between mouse allergen reduction and asthma outcomes.
RESULTS


Participants were predominantly low-income and minority (78% black, 22% Hispanic), and had persistent asthma. Among less atopic participants (<6 positive skin prick test results), each 50% reduction in mouse allergen was associated with fewer symptoms (incidence rate ratio [95% CI]: maximal symptoms: 0.94 [0.92-0.96]). There was little effect of mouse allergen reduction on symptoms among more atopic participants (P > .05). The interactions between atopic status and mouse allergen reduction were statistically significant for all symptom outcomes; however, there was no evidence that atopic status influenced the effect of mouse allergen reduction on exacerbation-related outcomes. Older children (≥9 years) tended to experience greater improvement in some asthma outcomes with reduction in mouse allergen exposure than younger children. There was no evidence that either mouse-specific IgE or lung function influenced the effect of mouse allergen reduction on any asthma outcomes.
CONCLUSIONS


Although there may be variability in the clinical response to mouse allergen reduction among low-income, minority children with asthma, there were no clinical characteristics that clearly identified a subgroup at which the intervention should be targeted.",2020,"There was no evidence that either mouse-specific IgE or lung function influenced the effect of mouse allergen reduction on any asthma outcomes.
","['Participants were predominantly low-income and minority (78% black, 22% Hispanic), and had persistent asthma', 'Older children (≥9 years']",[],[],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],[],,0.0739057,"There was no evidence that either mouse-specific IgE or lung function influenced the effect of mouse allergen reduction on any asthma outcomes.
","[{'ForeName': 'Ammara', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'S Christy', 'Initials': 'SC', 'LastName': 'Sadreameli', 'Affiliation': 'Division of Pediatric Pulmonology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Curtin-Brosnan', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Torie', 'Initials': 'T', 'LastName': 'Grant', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard University Medical School, Boston, Mass.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Perzanowski', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Balcer-Whaley', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Peng', 'Affiliation': 'Department of Biostatistics, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Newman', 'Affiliation': 'Division of Pediatric Allergy/Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Amparito', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': ""Division of Pediatric Allergy/Immunology, Boston Children's Hospital, Harvard University Medical School, Boston, Mass.""}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Divjan', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Bollinger', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Miller', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, College of Physicians and Surgeons, Columbia University, New York, NY.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Chew', 'Affiliation': 'Department of Environmental Health Sciences, Mailman School of Public Health, Columbia University, New York, NY.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Matsui', 'Affiliation': 'Department of Population Health and Pediatrics, Dell Medical School at the University of Texas, Austin, Tex. Electronic address: Elizabeth.matsui@austin.utexas.edu.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.08.044']
2993,31357256,Exercise Training Is Safe and Feasible in Patients Awaiting Liver Transplantation: A Pilot Randomized Controlled Trial.,,2019,,['Patients Awaiting Liver Transplantation'],['Exercise Training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]",[],,0.07265,,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Wallen', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Department of Anesthesia, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ingrid J', 'Initials': 'IJ', 'LastName': 'Hickman', 'Affiliation': 'Department of Nutrition and Dietetics, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Toby G', 'Initials': 'TG', 'LastName': 'Pavey', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland, Australia.'}, {'ForeName': 'Aidan J', 'Initials': 'AJ', 'LastName': 'Woodward', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Graeme A', 'Initials': 'GA', 'LastName': 'Macdonald', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jeff S', 'Initials': 'JS', 'LastName': 'Coombes', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement and Nutrition Sciences, University of Queensland, Brisbane, Queensland, Australia.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25616']
2994,32067633,Biannual Treatment of Preschool Children with Single Dose Azithromycin to Reduce Mortality: Impact on Azithromycin Resistance in the MORDOR Trial in Tanzania.,"The  Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance  study showed that administration of biannual, single-dose azithromycin to preschool children reduces mortality. We sought to evaluate its impact on azithromycin resistance. Thirty randomly selected communities in Kilosa district, Tanzania, were randomized to receive 6-monthly single-dose azithromycin (∼20 mg/kg) versus placebo treatment of children aged 1-59 months. From each community, 40 children (aged 1-59 months) were randomly selected at baseline, 12 and 24 months. Isolation and resistance testing of  Streptococcus pneumoniae  and  Escherichia coli  were evaluated using nasopharyngeal and rectal swabs, respectively. The carriage prevalence and the proportion of azithromycin-resistant isolates were determined using disk diffusion. At baseline, the characteristics of the randomly selected children were similar by treatment arms. Both at baseline and in annual cross-sectional surveys, rates of  S. pneumoniae  and  E. coli  isolation between treatment arms were similar. The proportions of azithromycin-resistant  S. pneumoniae  isolates in the children in communities treated with azithromycin versus placebo at baseline, 12 months, and 24 months were 26.5% (18.1%;  P  = 0.26), 26.8% (16.5%;  P  = 0.29), and 13.4% (17.0%;  P  = 0.57), respectively. The proportions of azithromycin-resistant  E. coli  isolates at baseline, 12 months, and 24 months in the azithromycin (versus placebo) arms were 14.9% (18.9%;  P  = 0.16), 21.5% (16.6%;  P  = 0.10), and 14.9% (14.7%;  P  = 0.95), respectively. Over the 24 months, the mean treatment coverage for the azithromycin and placebo was 76.9% and 74.8%, respectively ( P  = 0.49). Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.",2020,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"['Thirty randomly selected communities in Kilosa district, Tanzania', '40 children (aged 1-59 months', 'Preschool Children with Single Dose']","['placebo', 'azithromycin', 'Azithromycin', 'azithromycin versus placebo']","['mean treatment coverage', 'rates of  S. pneumoniae  and  E. coli  isolation', 'Mortality', 'mortality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",30.0,0.109285,Biannual administration of single-dose azithromycin to children did not appear to result in excess azithromycin resistance in  S. pneumoniae  and  E. coli  isolates over 24 months of follow-up.,"[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Bloch', 'Affiliation': 'Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Coles', 'Affiliation': 'Infectious Disease Clinical Research Program, Uniformed University of the Health Sciences, Bethesda, Maryland.'}, {'ForeName': 'Mabula', 'Initials': 'M', 'LastName': 'Kasubi', 'Affiliation': 'Department of Microbiology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Jerusha', 'Initials': 'J', 'LastName': 'Weaver', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Zakayo', 'Initials': 'Z', 'LastName': 'Mrango', 'Affiliation': 'National Institute for Medical Research, Kilosa, Tanzania.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Munoz', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Johns Hopkins School of Medicine, Baltimore, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0086']
2995,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
2996,31831295,Randomised Clinical Trial of Prostatic Artery Embolisation Versus a Sham Procedure for Benign Prostatic Hyperplasia.,"BACKGROUND


Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking.
OBJECTIVE


To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH.
DESIGN, SETTING, AND PARTICIPANTS


A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study.
INTERVENTION


Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively.
RESULTS AND LIMITATIONS


Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo.
CONCLUSIONS


The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect.
PATIENT SUMMARY


Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.",2020,"Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.","['Benign Prostatic Hyperplasia', '80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation', 'patients with typical symptoms associated with benign prostatic hyperplasia']","['Prostatic artery embolisation (PAE', 'Prostatic Artery Embolisation Versus a Sham Procedure', 'prostatic artery embolisation (PAE', 'PAE', 'successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation']","['IPSS', 'safety and efficacy', 'IPSS and QoL', 'Adverse events', 'QoL score', 'International Prostate Symptom Score (IPSS) and the quality of life (QoL) score']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0034380'}]",,0.429283,"Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.","[{'ForeName': 'João Martins', 'Initials': 'JM', 'LastName': 'Pisco', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Bilhim', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Nuno V', 'Initials': 'NV', 'LastName': 'Costa', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Torres', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Pisco', 'Affiliation': 'Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal.'}, {'ForeName': 'Luis Campos', 'Initials': 'LC', 'LastName': 'Pinheiro', 'Affiliation': 'Radiology Department, NOVA Medical School, Lisbon, Portugal; Urology Department, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal.'}, {'ForeName': 'Antonio Gouveia', 'Initials': 'AG', 'LastName': 'Oliveira', 'Affiliation': 'Department of Pharmacy, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN, Brazil. Electronic address: oliveira.amg@gmail.com.'}]",European urology,['10.1016/j.eururo.2019.11.010']
2997,31356452,Sustained efficacy of kangaroo care for repeated painful procedures over neonatal intensive care unit hospitalization: a single-blind randomized controlled trial.,"Preterm neonates hospitalized in the neonatal intensive care unit undergo frequent painful procedures daily, often without pain treatment, with associated long-term adverse effects. Maternal-infant skin-to-skin contact, or kangaroo care (KC), and sweet-tasting solutions such as sucrose are effective strategies to reduce pain during a single procedure; however, evidence of sustained efficacy over repeated procedures is limited. We aimed to determine the relative sustained efficacy of maternal KC, administered alone or in combination with 24% sucrose, to reduce behavioral pain intensity associated with routine neonatal procedures, compared with 24% sucrose alone. Stable preterm infants (n = 242) were randomized to receive KC and water, KC and 24% sucrose, or 24% sucrose before all routine painful procedures throughout their neonatal intensive care unit stay. Pain intensity, determined using the Premature Infant Pain Profile, was measured during 3 medically indicated heel lances distributed across hospitalization. Maternal and neonatal baseline characteristics, Premature Infant Pain Profile scores at 30, 60, or 90 seconds after heel lance, the distribution of infants with pain scores suggesting mild, moderate, or severe pain, Neurobehavioral Assessment of the Preterm Infant scores, and incidence of adverse outcomes were not statistically significantly different between groups. Maternal KC, as a pain-relieving intervention, remained efficacious over time and repeated painful procedures without evidence of any harm or neurological impact. It seemed to be equally effective as 24% oral sucrose, and the combination of maternal KC and sucrose did not seem to provide additional benefit, challenging the existing recommendation of using sucrose as the primary standard of care.",2019,"Maternal KC, as a pain-relieving intervention, remained efficacious over time and repeated painful procedures without evidence of any harm or neurological impact.","['Stable preterm infants (n = 242', 'Preterm neonates hospitalized in the neonatal intensive care unit undergo frequent painful procedures daily, often without pain treatment, with associated long-term adverse effects', 'neonatal intensive care unit hospitalization']","['kangaroo care', 'maternal KC, administered alone or in combination with 24% sucrose', 'KC and water, KC and 24% sucrose, or 24% sucrose before all routine painful procedures']","['Premature Infant Pain Profile', 'distribution of infants with pain scores suggesting mild, moderate, or severe pain, Neurobehavioral Assessment of the Preterm Infant scores, and incidence of adverse outcomes', 'Maternal-infant skin-to-skin contact, or kangaroo care (KC', 'Maternal and neonatal baseline characteristics, Premature Infant Pain Profile scores', 'behavioral pain intensity', 'Pain intensity']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4042798', 'cui_str': 'Long Term Adverse Effects'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0262705', 'cui_str': 'Kangaroo care (regime/therapy)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0262705', 'cui_str': 'Kangaroo care (regime/therapy)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.24788,"Maternal KC, as a pain-relieving intervention, remained efficacious over time and repeated painful procedures without evidence of any harm or neurological impact.","[{'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Campbell-Yeo', 'Affiliation': 'Department of Pediatrics, Psychology and Neuroscience, School of Nursing, Faculty of Health, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'C Celeste', 'Initials': 'CC', 'LastName': 'Johnston', 'Affiliation': 'Ingram School of Nursing, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Britney', 'Initials': 'B', 'LastName': 'Benoit', 'Affiliation': 'Centre for Pediatric Pain Research, Isaac Walton Killam Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Disher', 'Affiliation': 'Centre for Pediatric Pain Research, Isaac Walton Killam Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Caddell', 'Affiliation': 'Centre for Pediatric Pain Research, Isaac Walton Killam Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vincer', 'Affiliation': 'Centre for Pediatric Pain Research, Isaac Walton Killam Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Claire-Dominique', 'Initials': 'CD', 'LastName': 'Walker', 'Affiliation': 'Neuroscience Research Division, Douglas Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Latimer', 'Affiliation': 'Centre for Pediatric Pain Research, Isaac Walton Killam Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Darlene', 'Initials': 'D', 'LastName': 'Inglis', 'Affiliation': 'Neonatal Intensive Care Unit, IWK Health Centre Halifax, NS, Canada.'}]",Pain,['10.1097/j.pain.0000000000001646']
2998,32067628,Malaria Parasitemia and Nutritional Status during the Low Transmission Season in the Presence of Azithromycin Distribution among Preschool Children in Niger.,"The relationship between malaria and malnutrition is complicated, and existence of one may predispose or exacerbate the other. We evaluated the relationship between malaria parasitemia and nutritional status in children living in communities participating in a cluster-randomized trial of biannual azithromycin compared with placebo for prevention of childhood mortality. Data were collected during the low malaria transmission and low food insecurity season. Parasitemia was not associated with weight-for-height  Z -score (24 months:  P  = 0.11 azithromycin communities,  P  = 0.75 placebo communities), weight-for-age  Z -score (24 months:  P  = 0.83 azithromycin,  P  = 0.78 placebo), height-for-age  Z -score (24 months:  P  = 0.30 azithromycin,  P  = 0.87 placebo), or mid-upper arm circumference (24 months:  P  = 0.12 azithromycin,  P  = 0.56 placebo). There was no statistically significant evidence of a difference in the relationship in communities receiving azithromycin or placebo. During the low transmission season, there was no evidence that malaria parasitemia and impaired nutritional status co-occur in children.",2020,Parasitemia was not associated with weight-for-height  Z -score,"['children living in communities participating in a cluster-randomized trial of', 'Preschool Children in Niger']","['placebo', 'biannual azithromycin', 'azithromycin']","['Malaria Parasitemia and Nutritional Status', 'height-for-age  Z', 'weight-for-age  Z -score', 'Parasitemia', 'malaria parasitemia and nutritional status', 'childhood mortality', 'malaria parasitemia', 'score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0869806,Parasitemia was not associated with weight-for-height  Z -score,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nameywa', 'Initials': 'N', 'LastName': 'Boubacar', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Salissou', 'Initials': 'S', 'LastName': 'Kane', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': 'For The Mordor Study Group', 'Affiliation': ''}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0547']
2999,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3000,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3001,32055041,The effect of zoledronic acid on attenuation of bone loss at the hip and knee following acute traumatic spinal cord injury: a randomized-controlled study.,"STUDY DESIGN


Randomized double blind, placebo-controlled trial.
OBJECTIVES


To examine the effect of early intravenous zoledronic acid (ZA) on bone markers and areal bone mineral density (aBMD) in persons with acute ASIA Impairment Scale (AIS) A traumatic spinal cord injury (SCI).
SETTING


Two inpatient rehabilitation units.
METHODS


Thirteen men, 2 women, aged 19-65, C4-T10 AIS A SCI, received 5 mg intravenous ZA vs. placebo 12-21 days post injury. Markers of bone formation (procollagen N-1 terminal propeptide [P1NP]), bone resorption (serum C-telopeptide [CTX]), and aBMD by dual-energy X-ray absorptiometry (DXA) for hip (femur-proximal, intertrochanteric, neck), and knee (distal femur, proximal tibia) were obtained at baseline, 2 weeks post infusion (P1NP, CTX only), 4 and 12 months post injury.
RESULTS


P1NP remained unchanged, while CTX decreased in ZA but increased in controls at 2 weeks (mean difference = -97%, p < 0.01), 4 months (mean difference = -54%, p < 0.05), but not 12 months (mean difference = 3%, p = 0.23). Changes in aBMD at the hip favored ZA at 4 months (mean difference 10.3-14.1%, p < 0.01) and 12 months (mean difference 10.8-13.1%, p < 0.02). At 4 months, changes in aBMD favored ZA at the distal femur (mean difference 6.0%, 95% CI: 0.7-11.2, p < 0.03) but not proximal tibia (mean difference 8.3%, 95% CI: -6.9 to 23.6, p < 0.23). Both groups declined in aBMD at 12 months, with no between group differences.
CONCLUSION


ZA administered ≤21 days of complete traumatic SCI maintains aBMD at the hip and distal femur at 4 months post injury. This effect is partially maintained at 12 months.",2020,"Changes in aBMD at the hip favored ZA at 4 months (mean difference 10.3-14.1%, p < 0.01) and 12 months (mean difference 10.8-13.1%, p < 0.02).","['acute traumatic spinal cord injury', 'persons with acute ASIA Impairment Scale (AIS', 'Two inpatient rehabilitation units', '12-21 days post injury', 'Thirteen men, 2 women, aged 19-65, C4-T10 AIS A SCI, received']","['ZA', 'placebo', '5\u2009mg intravenous ZA vs. placebo', 'zoledronic acid', 'zoledronic acid (ZA']","['Markers of bone formation (procollagen N-1 terminal propeptide [P1NP]), bone resorption (serum C-telopeptide [CTX]), and aBMD by dual-energy X-ray absorptiometry (DXA) for hip (femur-proximal, intertrochanteric, neck), and knee (distal femur, proximal tibia', 'proximal tibia', 'bone markers and areal bone mineral density (aBMD', 'changes in aBMD', 'CTX decreased in ZA', 'bone loss', 'aBMD', 'Changes in aBMD']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}]","[{'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0588198', 'cui_str': 'Bone structure of proximal tibia (body structure)'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",,0.482131,"Changes in aBMD at the hip favored ZA at 4 months (mean difference 10.3-14.1%, p < 0.01) and 12 months (mean difference 10.8-13.1%, p < 0.02).","[{'ForeName': 'Christina V', 'Initials': 'CV', 'LastName': 'Oleson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, OH, USA. christinavoleson@msn.com.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Marino', 'Affiliation': 'Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Formal', 'Affiliation': 'Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Modlesky', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Leiby', 'Affiliation': 'Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}]",Spinal cord,['10.1038/s41393-020-0431-9']
3002,32057627,Effects of Extremity Massage on Preoperative Anxiety: A Three-Arm Randomized Controlled Clinical Trial on Phacoemulsification Candidates.,"PURPOSE


The present study aimed to compare the effects of foot and hand massage on preoperative anxiety.
DESIGN


Three-arm randomized, nonblinded, placebo-controlled, parallel group trial.
METHODS


This study was conducted on 90 female candidates waiting for phacoemulsification cataract surgery in Arak Amirkabir Hospital, Iran. Patients were consecutively selected and randomly divided into three groups of hand (n = 30), foot (n = 30), and placebo (n = 30), using a random number generator software program. In each group, massage was performed 5 minutes for each hand or foot in the surgical waiting room about 10 minutes before surgery. Anxiety was measured before and after the intervention by visual analog scale and also assessing physiological indicators (heart rate, respiratory rate, systolic and diastolic blood pressures).
FINDINGS


All the 90 patients completed the study and were included in the final analysis. Both hand and foot massage resulted in a significant decrease compared with placebo massage in anxiety and heart rate. However, no significant difference was found between hand and foot massage in any of the measured parameters. In the foot group and hand group, a significant reduction was observed in heart rate and anxiety after the intervention, whereas the anxiety increased significantly in the placebo group after the intervention. Moreover, systolic blood pressure in the foot group and the respiratory rate in the hand group significantly decreased after the intervention.
CONCLUSIONS


Application of hand or foot massage seems to be effective in managing anxiety in patients waiting for phacoemulsification cataract surgery.",2020,"In the foot group and hand group, a significant reduction was observed in heart rate and anxiety after the intervention, whereas the anxiety increased significantly in the placebo group after the intervention.","['90 patients completed the study and were included in the final analysis', '90 female candidates waiting for phacoemulsification cataract surgery in Arak Amirkabir Hospital, Iran', 'patients waiting for phacoemulsification cataract surgery']","['foot and hand massage', 'placebo', 'Phacoemulsification Candidates', 'placebo massage', 'Extremity Massage']","['Anxiety', 'systolic blood pressure', 'anxiety', 'Preoperative Anxiety', 'visual analog scale and also assessing physiological indicators (heart rate, respiratory rate, systolic and diastolic blood pressures', 'respiratory rate', 'anxiety and heart rate', 'heart rate and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0542399', 'cui_str': 'Patient waiting for (contextual qualifier) (qualifier value)'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",90.0,0.0485843,"In the foot group and hand group, a significant reduction was observed in heart rate and anxiety after the intervention, whereas the anxiety increased significantly in the placebo group after the intervention.","[{'ForeName': 'Moloud', 'Initials': 'M', 'LastName': 'Farmahini Farahani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Noruzi Zamenjani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran; Department of Operating Room Nursing, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Shamsikhani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Purfarzad', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Harorani', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Electronic address: m.harorani@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.10.010']
3003,31595851,"Change in Quality of Life of OSAHS Patients with Minimally Invasive Surgery or CPAP Therapy: A 2-year Retrospective, Single-center Parallel-group Study.","BACKGROUND


By including untreated obstructive sleep apnea-hypopnea syndrome (OSAHS) patients as the control group, this study explores the influence of minimally invasive surgical treatment and continuous positive airway pressure (CPAP) therapy on OSAHS patients, with the subjective and objective performance. The study also discusses their relationship, determines the effect factor, and provides a simple and practical method for evaluation of clinical efficacy.
METHODS


A total of 90 OSAHS patients, who were diagnosed in the Sleep Disorders Diagnosis and Treatment Center of Sichuan Province from May 2014 to May 2016, were selected for the present study. These patients were divided into three groups: surgery group, CPAP group, and untreated group. These patients were followed up at six months, one year, and two years, respectively. The physiological indicators, clinical symptoms, degree of daytime sleepiness and quality of life were compared among these three groups. The daytime sleepiness and the quality of life before and after minimally invasive surgery and CPAP treatment were evaluated, and the subjective and objective efficacy of surgery and CPAP treatment was explored.
RESULTS


Among these 90 patients, 11 (12.2%) patients had hypertension, while two (2.2%) patients had diabetes. The average AHI score was 50.53±23.39 per hour, and the mean minimum oxygen saturation and mean oxygen saturation was 71.25±14.16% and 90.13±5.90%, respectively. There were statistically significant differences in mouth breathing, morning sore throat and daytime sleepiness in the group having received surgery at 0.5 year and one year. In the CPAP group, there were statistically significant differences in mouth breathing, morning sore throat and daytime sleepiness at 0.5 year, one year and two years. Moreover, there were statistically significant differences in memory loss at one year and two years, and there were statistically significant differences in frequent nocturia at one year. The ESS value in the surgery group decreased at 0.5 year and one year, but increased at two years. The situation was the same in terms of the total points and in each dimension of the SF-36 paramter. The delta values of ESS among the three groups had statistical significance at 0.5 year, one year and two years, in which the CPAP group experienced the most changes, followed by the surgery group and the group received health education.
CONCLUSION


For minimally invasive surgery, CPAP therapy and health education can improve daytime sleepiness and quality of life. CPAP therapy was found to be the most effective, followed by minimally invasive surgery and provision of health education. However, the treatment of OSAHS should be comprehensive.",2020,"In the CPAP group, there were statistically significant differences in mouth breathing, morning sore throat and daytime sleepiness at 0.5 year, one year and two years.","['untreated obstructive sleep apnea-hypopnea syndrome (OSAHS) patients', 'OSAHS Patients with Minimally Invasive Surgery or CPAP Therapy', '90 OSAHS patients, who were diagnosed in the Sleep Disorders Diagnosis and Treatment Center of Sichuan Province from May 2014 to May 2016, were selected for the present study', '90 patients, 11 (12.2%) patients had hypertension, while two (2.2%) patients had diabetes']","['CPAP', 'minimally invasive surgical treatment and continuous positive airway pressure (CPAP) therapy', 'OSAHS', 'minimally invasive surgery, CPAP therapy and health education', 'CPAP therapy']","['daytime sleepiness and the quality of life', 'delta values of ESS', 'physiological indicators, clinical symptoms, degree of daytime sleepiness and quality of life', 'average AHI score', 'frequent nocturia', 'daytime sleepiness and quality of life', 'mouth breathing, morning sore throat and daytime sleepiness', 'memory loss', 'mean minimum oxygen saturation and mean oxygen saturation', 'Quality of Life', 'ESS value']","[{'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0018701'}]","[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0034380'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0026635', 'cui_str': 'Mouth Breathing'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0751295', 'cui_str': 'Memory Loss'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]",90.0,0.0242236,"In the CPAP group, there were statistically significant differences in mouth breathing, morning sore throat and daytime sleepiness at 0.5 year, one year and two years.","[{'ForeName': 'Xiao-Qing', 'Initials': 'XQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Occupational Health and Sleep Medicine Center, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'West China Second University Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Pei-Wei', 'Initials': 'PW', 'LastName': 'Hong', 'Affiliation': 'Department of Geriatrics and Neurology, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Occupational Health and Sleep Medicine Center, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zeng', 'Affiliation': 'Department of Occupational Health and Sleep Medicine Center, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Yangzhou Health Supervision Institute, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Occupational Health and Sleep Medicine Center, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Occupational Health and Sleep Medicine Center, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Jiang', 'Affiliation': 'Department of Occupational Health and Sleep Medicine Center, West China School of Public Health and West China Forth Hospital, Sichuan University, Chengdu, Sichuan, China.'}]",Current molecular medicine,['10.2174/1566524019666191009150734']
3004,31353695,Effect of Pereskia aculeata Mill. in vitro and in overweight humans: A randomized controlled trial.,"OBJECTIVES


The objective of this study was to investigate the influence of ora-pro-nobis (Pereskia aculeata Mill.) flour on the adhesion of probiotics to intestinal epithelial cells and to evaluate the effect of a product based on this flour on gastrointestinal symptoms, weight, body fat, glycemia, and lipid profile in overweight men.
METHODS


Microbiological counts (probiotic count, survival after in vitro gastrointestinal resistance, Caco-2 cell adhesion) were analyzed. A randomized, cross-over intervention was performed. Intestinal microbiota was indirectly assessed on the basis of consistency, color of feces, and gastrointestinal symptoms.
RESULTS


P. aculeata did not affect Lactobacillus casei adhesion to Caco-2 cells. Ora-pro-nobis flour improved gastrointestinal symptoms and increased satiety.
CONCLUSION


The consumption of ora-pro-nobis flour improved intestinal health. In addition, it maintained the high adherence of L. casei to intestinal cells as well as patient anthropometric and biochemical parameters.
PRACTICAL APPLICATIONS


Pereskia aculeata Mill. is well known in folk medicine and has several nutrients; however, there are few studies on this plant. This is the first study to analyze the influence of P. aculeata on bacterial adherence and the first cross-over clinical trial to evaluate the beneficial potential of ora-pro-nobis flour in overweight men. Thus, this study will contribute to the promotion of ora-pro-nobis as a functional ingredient and will arouse the interest of industries to develop related healthy foods. In addition, it is an effective dietary strategy to improve the gastrointestinal health of men.",2019,"Ora-pro-nobis flour improved gastrointestinal symptoms and increased satiety.
","['overweight men', 'overweight humans']","['ora-pro-nobis flour', 'ora-pro-nobis (Pereskia aculeata Mill', 'Pereskia aculeata Mill']","['Microbiological counts (probiotic count, survival after in vitro gastrointestinal resistance, Caco-2 cell adhesion', 'gastrointestinal symptoms and increased satiety', 'gastrointestinal symptoms, weight, body fat, glycemia, and lipid profile', 'Lactobacillus casei adhesion to Caco-2 cells', 'Intestinal microbiota']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0599997', 'cui_str': 'Mill (environment)'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0282560', 'cui_str': 'Caco-2 Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}]",,0.0265176,"Ora-pro-nobis flour improved gastrointestinal symptoms and increased satiety.
","[{'ForeName': 'Camilla Ribeiro', 'Initials': 'CR', 'LastName': 'Vieira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Bárbara Pereira', 'Initials': 'BP', 'LastName': 'da Silva', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Mariana Araújo Vieira', 'Initials': 'MAV', 'LastName': 'do Carmo', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Azevedo', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Denismar Alves', 'Initials': 'DA', 'LastName': 'Nogueira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Hércia Stampini', 'Initials': 'HS', 'LastName': 'Duarte Martino', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Roberta Ribeiro', 'Initials': 'RR', 'LastName': 'Silva', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}]",Journal of food biochemistry,['10.1111/jfbc.12903']
3005,31406274,Differences in exposure to toxic and/or carcinogenic volatile organic compounds between Black and White cigarette smokers.,"OBJECTIVE


It is unclear why Black smokers in the United States have elevated risk of some tobacco-related diseases compared to White smokers. One possible causal mechanism is differential intake of tobacco toxicants, but results across studies are inconsistent. Thus, we examined racial differences in biomarkers of toxic volatile organic compounds (VOCs) present in tobacco smoke.
METHOD


We analyzed baseline data collected from 182 Black and 184 White adult smokers who participated in a randomized clinical trial in 2013-2014 at 10 sites across the United States. We examined differences in urinary levels of ten VOC metabolites, total nicotine equivalents (TNE), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), controlling for covariates such as cigarettes per day (CPD), as well as differences in VOCs per TNE to assess the extent to which tobacco exposure, and not metabolic factors, accounted for racial differences.
RESULTS


Concentration of metabolites of acrolein, acrylonitrile, ethylene oxide, and methylating agents were significantly higher in Blacks compared to Whites when controlled for covariates. Other than the metabolite of methylating agents, VOCs per TNE did not differ between Blacks and Whites. Concentrations of TNE/CPD and VOCs/CPD were significantly higher in Blacks. Menthol did not contribute to racial differences in VOC levels.
CONCLUSIONS


For a given level of CPD, Black smokers likely take in higher levels of acrolein, acrylonitrile, and ethylene oxide than White smokers. Our findings are consistent with Blacks taking in more nicotine and toxicants per cigarette smoked, which may explain their elevated disease risk relative to other racial groups.",2019,Concentrations of TNE/CPD and VOCs,"['182 Black and 184 White adult smokers who participated in a randomized clinical trial in 2013-2014 at 10 sites across the United States', 'Black smokers', 'Black and White cigarette smokers']",['Menthol'],"['urinary levels of ten VOC metabolites, total nicotine equivalents (TNE), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), controlling for covariates such as cigarettes per day (CPD', 'Concentrations of TNE/CPD and VOCs', 'Concentration of metabolites of acrolein, acrylonitrile, ethylene oxide, and methylating agents', 'CPD']","[{'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0243173', 'cui_str': 'urinary levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0389836', 'cui_str': '4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001204', 'cui_str': 'Acraldehyde'}, {'cui': 'C0001223', 'cui_str': 'Vinyl Cyanide'}, {'cui': 'C0015087', 'cui_str': 'Ethylene Oxide'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]",,0.0263075,Concentrations of TNE/CPD and VOCs,"[{'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA. Gideon.Sthelen@ucsf.edu.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gregorich', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Eliseo J', 'Initials': 'EJ', 'LastName': 'Pérez-Stable', 'Affiliation': 'Division of Intramural Research, National Heart, Lung and Blood Institute and Office of the Director, National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Hecht', 'Affiliation': 'Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Journal of exposure science & environmental epidemiology,['10.1038/s41370-019-0159-9']
3006,31855259,Idelalisib for Treatment of Relapsed Follicular Lymphoma and Chronic Lymphocytic Leukemia: A Comparison of Treatment Outcomes in Clinical Trial Participants vs Medicare Beneficiaries.,"Importance


Idelalisib (IDEL) is approved as monotherapy in relapsed follicular lymphoma (FL) and with rituximab (IDEL+R) for relapsed chronic lymphocytic leukemia (CLL). Toxic effects can be severe and treatment-limiting. Outcomes in a real-world population are not yet characterized.
Objective


We compared IDEL treatment outcomes in the clinical setting with outcomes in clinical trial data.
Design, Setting, and Participants


This cohort study compared clinical trial participants treated with IDEL, aged 65 years or older, in studies 101-09 and 312-0116 with Medicare beneficiaries treated with IDEL of the same disease state and treatment regimen. Study 101-09 was a phase 2, single-group, open-label trial supporting accelerated approval of IDEL for relapsed or refractory FL. Study 312-0116 was a phase 3, multicenter, randomized, double-blind trial supporting approval of IDEL+R for relapsed CLL. Analyses were conducted between February and December 2018.
Main Outcomes and Measures


Treatment duration, on-treatment and overall mortality, and serious and fatal infections were compared between trial participants and Medicare beneficiaries. Cox proportional hazards models quantified differences by cohort.
Results


We identified 26 trial participants (mean [SD] age, 73 [4.9] years; 12 [46.2%] women) and 305 Medicare beneficiaries (mean [SD] age, 76 [6.9] years; 103 [54.8%] women) receiving IDEL for FL and 89 trial participants (mean [SD] age, 74 [6.0] years; 30 [33.7%] women) and 294 Medicare beneficiaries (mean age, 76 [6.3] years; 111 [37.8%] women) receiving IDEL+R for CLL. Medicare beneficiaries were older with higher comorbidity; had a shorter median treatment duration for CLL (173 days vs 473 days, P < .001) but not FL (114, days vs 160 days, P = .38); a numerically higher mortality rate (CLL: HR, 1.40; 95% CI, 0.93-2.11; FL: HR, 1.39; 95% CI, 0.69-2.78); and a significantly higher fatal infection rate per 100 person-years for CLL (18.4 vs 9.8, P = .04) and a numerically higher rate for FL (27.6 vs 18.6, P = .54), compared with trial participants. Trial participants had approximately twice as many dose reductions (CLL: 32.6% vs 18.0%; P = .003; FL: 38.5% vs 16.1%; P = .02). Among Medicare beneficiaries, a hospitalized infection within 6 months prior to IDEL initiation was associated with a 2.11-fold increased risk for on-treatment fatal infections (95% CI, 1.44-3.10). Despite a March 2016 recommendation for Pneumocystis jirovecii pneumonia prophylaxis in patients treated with IDEL, prophylaxis rates were low after March 2016 (FL: 25%, CLL: 37%).
Conclusions and Relevance


We observed substantial imbalances in baseline comorbidities and treatment outcomes between Medicare beneficiaries and trial participants aged 65 years or older. Immunosuppression-related toxic effects, including infections, may have been somewhat reduced in trials by more frequent dose reductions and exclusion of patients with ongoing infections. Selective eligibility criteria and closer monitoring of trial patients may be responsible for limited generalizability of trial data to clinical practice.",2020,Trial participants had approximately twice as many dose reductions (CLL: 32.6% vs 18.0%; P = .003; FL: 38.5% vs 16.1%; P = .02).,"['Clinical Trial Participants vs Medicare Beneficiaries', '26 trial participants (mean [SD] age, 73 [4.9] years; 12 [46.2%] women) and 305 Medicare beneficiaries (mean [SD] age, 76 [6.9] years; 103 [54.8%] women) receiving IDEL for FL and 89 trial participants (mean [SD] age, 74 [6.0] years; 30 [33.7%] women) and 294 Medicare beneficiaries (mean age, 76 [6.3] years; 111 [37.8%] women) receiving', 'clinical trial participants treated with IDEL, aged 65 years or older, in studies 101-09 and 312-0116 with Medicare beneficiaries treated with IDEL of the same disease state and treatment regimen', 'Medicare beneficiaries and trial participants aged 65 years or older', 'relapsed follicular lymphoma (FL) and with rituximab (IDEL+R) for relapsed chronic lymphocytic leukemia (CLL', 'Relapsed Follicular Lymphoma and Chronic Lymphocytic Leukemia']","['IDEL+R', 'Importance\n\n\nIdelalisib (IDEL', 'Idelalisib', 'IDEL+R for CLL']","['Main Outcomes and Measures\n\n\nTreatment duration, on-treatment and overall mortality, and serious and fatal infections', 'Toxic effects', 'mortality rate', 'fatal infection rate', 'prophylaxis rates', 'median treatment duration for CLL']","[{'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}]",305.0,0.403362,Trial participants had approximately twice as many dose reductions (CLL: 32.6% vs 18.0%; P = .003; FL: 38.5% vs 16.1%; P = .02).,"[{'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Bird', 'Affiliation': 'Office of Pharmacovigilance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Tian', 'Affiliation': 'Office of Pharmacovigilance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Flowers', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Przepiorka', 'Affiliation': 'Office of Hematology and Oncology Products, Division of Hematology Products, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Rongrong', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Tae-Hyun', 'Initials': 'TH', 'LastName': 'Jung', 'Affiliation': 'Division of Biometrics, Office of Biostatistics, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Zebulin', 'Initials': 'Z', 'LastName': 'Kessler', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Woods', 'Affiliation': 'Office of Pharmacovigilance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Barry W', 'Initials': 'BW', 'LastName': 'Miller', 'Affiliation': 'Office of Hematology and Oncology Products, Division of Hematology Products, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wernecke', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Division of Biometrics, Office of Biostatistics, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'McKean', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gelperin', 'Affiliation': 'Office of Pharmacovigilance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'MaCurdy', 'Affiliation': 'Acumen LLC, Burlingame, California.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Kelman', 'Affiliation': 'Centers for Medicare & Medicaid Services, Woodlawn, Maryland.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Graham', 'Affiliation': 'Office of Pharmacovigilance and Epidemiology, Food and Drug Administration, Silver Spring, Maryland.'}]",JAMA oncology,['10.1001/jamaoncol.2019.3994']
3007,31353198,Assertive communication training and associate nurses' knowledge and motivation: A quasi experiment.,"OBJECTIVE


This study aimed to identify improvement in knowledge and motivation in associate nurses through assertive communication training in Southeast Sulawesi, Indonesia.
METHOD


The study used a quasi-experimental pre-test-post-test design with an intervention group and a control group approach.
RESULT


The assertive communication knowledge analysis results revealed a significant difference in the posttest 1 score (p=0.045). However, there was no significant difference in the posttest 2 score (p=0.390). The work motivation analysis revealed a significant difference in the post-test 1 score (p=0.009). However, there was no significant difference in the posttest 2 score (p=0.068). There was a significant difference in knowledge between the pretest and posttest 1 in both study groups (p<0.05).
CONCLUSION


The study's findings may serve as a reference for health organizations to cooperate with competent third parties organize assertive communication training for nurses.",2019,The work motivation analysis revealed a significant difference in the post-test 1 score (p=0.009).,"['Southeast Sulawesi, Indonesia']",['Assertive communication training'],['knowledge'],"[{'cui': 'C0376188', 'cui_str': 'Celebes'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0180369,The work motivation analysis revealed a significant difference in the post-test 1 score (p=0.009).,"[{'ForeName': 'Venny', 'Initials': 'V', 'LastName': 'Ardita', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Enie', 'Initials': 'E', 'LastName': 'Novieastari', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Gayatri', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: ditya.b@gmail.com.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.04.126']
3008,32035945,"Efficacy and safety of microneedling and oral tranexamic acid in the treatment of facial melasma in women: An open, evaluator-blinded, randomized clinical trial.",,2020,,['facial melasma in women'],['microneedling and oral tranexamic acid'],['Efficacy and safety'],"[{'cui': 'C0025218', 'cui_str': 'Chloasma'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.2716,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cassiano', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil. Electronic address: danielpcassiano@uol.com.br.'}, {'ForeName': 'Ana Cláudia Cavalcante', 'Initials': 'ACC', 'LastName': 'Esposito', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Karime', 'Initials': 'K', 'LastName': 'Hassun', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ediléia', 'Initials': 'E', 'LastName': 'Bagatin', 'Affiliation': 'Departamento de Dermatologia, Universidade Federal de São Paulo - Escola Paulista de Medicina, São Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mariana Modesto D A', 'Initials': 'MMDA', 'LastName': 'Lima', 'Affiliation': 'Santa Casa de Misericórdia, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Emerson V A', 'Initials': 'EVA', 'LastName': 'Lima', 'Affiliation': 'Santa Casa de Misericórdia, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Luciane Donida Bartoli', 'Initials': 'LDB', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - Faculdade de Medicina de Botucatu, Botucatu, São Paulo, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.02.002']
3009,29532416,The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial.,"Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized, double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 10 9  CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related variables. Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001). In addition, significant decreases in serum triglycerides (- 16.2 ± 31.4 vs. + 5.8 ± 23.1 mg/dL, P = 0.003), VLDL-cholesterol concentrations (- 3.3 ± 6.3 vs. + 1.1 ± 4.6 mg/dL, P = 0.003), and AIP (- 0.05 ± 0.08 vs. - 0.003 ± 0.10 mg/dL, P = 0.03) were seen following the supplementation of synbiotic compared with the placebo. Overall, we found that synbiotic supplementation to women with PCOS for 12 weeks had beneficial effects on markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP, but did not influence other lipid profiles. Trial registration: www.irct.ir: IRCT201604015623N71.",2019,"Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001).","['women with PCOS', 'women with polycystic ovary syndrome (PCOS', 'Sixty women with PCOS', 'Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017', 'Women With Polycystic Ovary Syndrome']","['placebo', 'Synbiotic Supplementation', 'intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771', 'placebo, synbiotic supplementation', 'synbiotic supplementation']","['serum insulin concentrations', 'VLDL-cholesterol concentrations', 'homeostasis model of assessment-insulin resistance', 'glycemic control, lipid profiles, and atherogenic index of plasma (AIP', 'quantitative insulin sensitivity check index', 'markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP', 'serum triglycerides', 'Fasting blood samples', 'Metabolic Status', 'glycemic control and lipid profiles']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",60.0,0.641325,"Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001).","[{'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Dadkhah', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Haddad Kashani', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Science Faculty, Islamic Azad University, Central Branch, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Seyed Hosseini', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9405-z']
3010,31402434,The Genetic Education for Men (GEM) Trial: Development of Web-Based Education for Untested Men in BRCA1/2-Positive Families.,"Cascade testing for hereditary breast/ovarian cancer is an important public health priority. Increasing attention has been paid to the relevance of testing for men within BRCA1/2-positive families given that such testing may provide important information about their cancer risks, particularly for prostate cancer, and risks to their offspring. However, men are much less likely to seek genetic counseling and testing than their at-risk female relatives. To facilitate access to pre-test information and testing, we developed a web-based intervention (WI) for men that we are evaluating in a pilot randomized controlled trial (RCT). This paper describes three phases of research in the development of the WI: (1) formative (qualitative) research among men from BRCA1/2 families to assess needs and preferences for education; (2) a detailed description of the organization, format, and content of the WI; and (3) usability testing. We discuss the aims and hypotheses of the pilot RCT in which the WI is being compared with an enhanced usual care condition among at-risk men. We expect that the WI described here will foster informed decisions and lead to increased use of BRCA1/2 counseling and testing, potentially yielding improved cancer control outcomes for this understudied group, and for their at-risk relatives.",2019,"To facilitate access to pre-test information and testing, we developed a web-based intervention (WI) for men that we are evaluating in a pilot randomized controlled trial (RCT).","['men within BRCA1/2-positive families', 'hereditary breast/ovarian cancer', 'Untested Men in BRCA1/2-Positive Families']",[],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439660', 'cui_str': 'Hereditary (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]",[],[],,0.0408716,"To facilitate access to pre-test information and testing, we developed a web-based intervention (WI) for men that we are evaluating in a pilot randomized controlled trial (RCT).","[{'ForeName': 'Beth N', 'Initials': 'BN', 'LastName': 'Peshkin', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA. peshkinb@georgetown.edu.'}, {'ForeName': 'Mary Kate', 'Initials': 'MK', 'LastName': 'Ladd', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Isaacs', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Segal', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Aryana', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Taylor', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Graves', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Schwartz', 'Affiliation': 'Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 3300 Whitehaven Street, NW, Suite 4100, Washington, DC, 20007, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01599-y']
3011,31930360,Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial.,"Importance


First-line behavioral and drug therapies for overactive bladder (OAB) symptoms in men are effective but not usually curative.
Objective


To determine whether combining behavioral and drug therapies improves outcomes compared with each therapy alone for OAB in men and to compare 3 sequences for implementing combined therapy.
Design, Setting, and Participants


In this 3-site, 2-stage, 3-arm randomized clinical trial, participants were randomized to 6 weeks of behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy for all groups. Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours. Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019.
Interventions


Behavioral therapy consisted of pelvic floor muscle training with urge suppression strategies and delayed voiding. Drug therapy included an antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg).
Main Outcomes and Measures


Seven-day bladder diaries completed before and after each 6-week treatment stage were used to calculate reduction in frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia). Other secondary outcomes included validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score.
Results


Of the 204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years. A total of 21 men discontinued treatment and 183 completed treatment. Mean (SD) voids per 24 hours decreased significantly in all 3 groups from baseline to 6-week follow-up (behavioral therapy: 11.7 [2.4] vs 8.8 [2.1]; change, 2.9 [2.4]; percentage change, 24.7%; P < .001; drug therapy: 11.8 [2.5] vs 10.3 [2.7]; change, 1.5 [2.3]; percentage change, 12.7%; P < .001; combined therapy: 11.8 [2.4] vs 8.2 [2.3]; change, 3.6 [2.1]; percentage change, 30.5%; P < .001). Intention-to-treat analyses indicated that posttreatment mean (SD) voiding frequencies were significantly lower in those receiving combined therapy compared with drug therapy alone (8.2 [2.3] vs 10.3 [2.7]; P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001). At 12-week follow-up, after all groups had received combined therapy, improvements in mean (SD) voids per 24 hours were also greatest for those receiving initial combined therapy compared with baseline (behavioral therapy: 11.7 [2.4] vs 8.0 [2.2]; change, 3.7 [2.3]; percentage change, 31.6%; P < .001; drug therapy: 11.8 [2.5] vs 8.6 [2.3]; change, 3.2 [2.5]; percentage change, 27.1%; P < .001; combined therapy: 11.8 [2.4] vs 8.0 [2.2]; change, 3.8 [2.1]; percentage change, 32.2%; P < .001), but there were no statistically significant group differences on primary or secondary measures.
Conclusions and Relevance


Combining behavioral and drug therapy yields greater improvements in OAB symptoms than drug therapy alone but not behavioral therapy alone. When using a stepped approach, it is reasonable to begin with behavioral therapy alone.
Trial Registration


ClinicalTrials.gov identifier: NCT01175382.",2020,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"['204 included men, 133 (65.2%) were white, and the mean (SD) age was 64.1 (11.1) years', 'Overactive Bladder Symptoms in Men', 'Data were collected from July 2010 to July 2015 and analyzed from April 2016 to September 2019', 'Participants were recruited from 3 outpatient clinics and included community-dwelling men 40 years or older with urinary urgency and 9 or more voids per 24 hours', '21 men discontinued treatment and 183 completed treatment']","['antimuscarinic (sustained-release tolterodine, 4 mg) plus an α-blocker (tamsulosin, 0.4 mg', 'behavioral therapy alone, drug therapy alone, or combined therapy followed by step-up to 6 weeks of combined therapy', 'Combined Behavioral and Drug Therapy', 'pelvic floor muscle training with urge suppression strategies and delayed voiding']","['Mean (SD) voids per 24 hours', 'mean (SD) voids', 'frequency of urination (primary outcome) and other symptoms (ie, urgency, urgency incontinence, and nocturia', 'OAB symptoms', 'validated patient global ratings of improvement and satisfaction, Overactive Bladder Questionnaire score, and International Prostate Symptom Score', 'posttreatment mean (SD) voiding frequencies', 'Main Outcomes and Measures\n\n\nSeven-day bladder diaries', 'overactive bladder (OAB) symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085606', 'cui_str': 'Urgent desire to urinate (finding)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C4521482', 'cui_str': 'Antimuscarinic'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456696', 'cui_str': '/24h'}, {'cui': 'C2584336', 'cui_str': 'Frequency of urination (observable entity)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}]",,0.0524237,P < .001) but not significantly lower compared with those receiving behavioral therapy alone (8.2 [2.3] vs 8.8 [2.1]; P = .19) and were lower for behavioral therapy alone compared with drug therapy alone (8.8 [2.1] vs 10.3 [2.7]; P < .001).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Kraus', 'Affiliation': 'Department of Urology, University of Texas Health Science Center at San Antonio, San Antonio.'}, {'ForeName': 'Theodore M', 'Initials': 'TM', 'LastName': 'Johnson', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Alayne D', 'Initials': 'AD', 'LastName': 'Markland', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Camille P', 'Initials': 'CP', 'LastName': 'Vaughan', 'Affiliation': 'Birmingham/Atlanta Geriatric Research, Education, and Clinical Center (GRECC), Department of Veterans Affairs, Atlanta, Georgia.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Redden', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham.'}, {'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Goode', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6398']
3012,31930364,Safety and Efficacy of RimabotulinumtoxinB for Treatment of Sialorrhea in Adults: A Randomized Clinical Trial.,"Importance


RimabotulinumtoxinB (RIMA) may be preferable as an anti-sialorrhea treatment compared with current oral anticholinergic drugs in people with neurological disorders.
Objective


To assess the safety, efficacy, and tolerability of RIMA injections for the treatment of sialorrhea in adults.
Design, Setting, and Participants


This randomized, parallel, double-blind, placebo-controlled clinical trial of RIMA 2500 U and 3500 U was conducted from November 14, 2013, to January 23, 2017. A total of 249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened. Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled. Patients had to have a minimum unstimulated salivary flow rate (USFR) of 0.2 g/min and a minimum Drooling Frequency and Severity Scale score of 4.
Exposures


Patients were randomized 1:1:1 to RIMA, 2500 U (n = 63); RIMA, 3500 U (n = 64); or placebo (n = 60).
Main Outcomes and Measures


Primary outcomes were the change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C) at week 4. The CGI-C scores were recorded on a 7-point scale ranging from very much improved to very much worse. Adverse events were recorded throughout the trial period.
Results


Of 187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years), 122 patients had Parkinson disease (65.2%), 13 (7.0%) were stroke survivors, 12 had amyotrophic lateral sclerosis (6.4%), 6 had medication-induced sialorrhea (3.2%), 4 had adult cerebral palsy (2.1%), and 30 had sialorrhea owing to other causes (16.0%). A total of 176 completed the study. Treatment with both doses of RIMA significantly reduced USFR at week 4 vs placebo (mean treatment difference, -0.30 g/min [95% CI, -0.39 to -0.21] for both doses vs placebo, P < .001). The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14 [95% CI, -1.49 to -0.80] for 3500 U, both P < .001). Treatment benefits were seen as early as 1 week after injection and were maintained over the treatment cycle of approximately 13 weeks. The RIMA injections were well tolerated compared with placebo. The most common adverse events were self-limited mild to moderate dry mouth, dysphagia, and dental caries.
Conclusions and Relevance


Treatment with RIMA (2500 U and 3500 U) in adults was well tolerated and reduced sialorrhea, with the onset of the effect at 1 week after the injection. These data support the clinical use of RIMA in the management of sialorrhea in adults.
Trial Registration


ClinicalTrials.gov Identifier: NCT01994109.",2020,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","['187 patients enrolled (147 men [78.6%]; mean [SD] age, 63.9 [13.3] years', 'A total of 176 completed the study', '122 patients had Parkinson disease (65.2%), 13 (7.0', 'Sialorrhea in Adults', '249 adult patients with troublesome sialorrhea secondary to any disorder or cause were screened', 'Of them, 13 refused further participation in the study or were lost to follow-up and 49 did not fulfill the criteria for participation; 187 were ultimately enrolled', 'people with neurological disorders', 'sialorrhea in adults']","['RIMA', 'RIMA injections', 'RimabotulinumtoxinB', 'placebo', 'RimabotulinumtoxinB (RIMA']","['adult cerebral palsy', 'amyotrophic lateral sclerosis', 'Safety and Efficacy', 'change in USFR from baseline to week 4 and the Clinical Global Impression of Change (CGI-C', 'tolerated and reduced sialorrhea', 'Adverse events', 'safety, efficacy, and tolerability', 'CGI-C scores', 'USFR', 'minimum Drooling Frequency and Severity Scale score of 4', 'minimum unstimulated salivary flow rate (USFR']","[{'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}]","[{'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2719430', 'cui_str': 'rimabotulinumtoxinB'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0002736', 'cui_str': 'ALS (Amyotrophic Lateral Sclerosis)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0037036', 'cui_str': 'Hypersalivation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated (qualifier value)'}, {'cui': 'C0429177', 'cui_str': 'Salivary flow rate (observable entity)'}]",249.0,0.347529,"The CGI-C scores were statistically significantly improved at week 4 for both treatment groups vs placebo (-1.21 [95% CI, -1.56 to -0.87] for 2500 U, -1.14","[{'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton, Florida.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ondo', 'Affiliation': 'Houston Methodist Neurological Institute, Houston, Texas.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'The University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Trosch', 'Affiliation': 'Franklin Neurology, Farmington Hills, Michigan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Molho', 'Affiliation': ""Parkinson's Disease and Movement Disorder Center, Albany Medical Center, Albany, New York.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lew', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles.'}, {'ForeName': 'Khashayar', 'Initials': 'K', 'LastName': 'Dashtipour', 'Affiliation': 'Loma Linda University Schools of Medicine and Pharmacy, Loma Linda, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Clinch', 'Affiliation': 'US WorldMeds LLC, Louisville, Kentucky.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': ""James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.4565']
3013,31930369,Extended Follow-up From a Randomized Clinical Trial of Routine Amoxicillin in the Treatment of Uncomplicated Severe Acute Malnutrition in Niger.,,2020,,['Uncomplicated Severe Acute Malnutrition in Niger'],['Routine Amoxicillin'],[],"[{'cui': 'C4042945', 'cui_str': 'Severe Acute Malnutrition'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]",[],,0.0562534,,"[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Kyra H', 'Initials': 'KH', 'LastName': 'Grantz', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Fatou', 'Initials': 'F', 'LastName': 'Berthé', 'Affiliation': 'Epicentre, Niamey, Niger.'}, {'ForeName': 'Myrto', 'Initials': 'M', 'LastName': 'Schaefer', 'Affiliation': 'Médecins Sans Frontières Operational Center Paris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Adehossi', 'Affiliation': 'National Hospital, Niamey, Niger.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5189']
3014,32040141,Comparison of Integrated Outpatient Palliative Care With Standard Care in Patients With Parkinson Disease and Related Disorders: A Randomized Clinical Trial.,"Importance


Parkinson disease and related disorders (PDRD) have consequences for quality of life (QoL) and are the 14th leading cause of death in the United States. Despite growing interest in palliative care (PC) for persons with PDRD, few studies are available supporting its effectiveness.
Objective


To determine if outpatient PC is associated with improvements in patient-centered outcomes compared with standard care among patients with PDRD and their caregivers.
Design, Setting, and Participants


This randomized clinical trial enrolled participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year. A total of 584 persons with PDRD were referred to the study. Of those, 351 persons were excluded by phone and 23 were excluded during in-person screenings. Patients were eligible to participate if they had PDRD and moderate to high PC needs. Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol. Enrolled participants were assigned to receive standard care plus outpatient integrated PC or standard care alone. Data were analyzed between November 1, 2018, and December 9, 2019.
Interventions


Outpatient integrated PC administered by a neurologist, social worker, chaplain, and nurse using PC checklists, with guidance and selective involvement from a palliative medicine specialist. Standard care was provided by a neurologist and a primary care practitioner.
Main Outcomes and Measures


The primary outcomes were the differences in patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview) between the PC intervention and standard care groups at 6 months.
Results


A total of 210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1 [8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9%) were white and non-Hispanic. Compared with participants receiving standard care alone at 6 months, participants receiving the PC intervention had better QoL (mean [SD], 0.66 [5.5] improvement vs 0.84 [4.2] worsening; treatment effect estimate, 1.87; 95% CI, 0.47-3.27; P = .009). No significant difference was observed in caregiver burden (mean [SD], 2.3 [5.0] improvement vs 1.2 [5.6] improvement in the standard care group; treatment effect estimate, -1.62; 95% CI, -3.32 to 0.09; P = .06). Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months. No outcomes favored standard care alone. Secondary analyses suggested that benefits were greater for persons with higher PC needs.
Conclusions and Relevance


Outpatient PC is associated with benefits among patients with PDRD compared with standard care alone. This study supports efforts to integrate PC into PDRD care. The lack of diversity and implementation of PC at experienced centers suggests a need for implementation research in other populations and care settings.
Trial Registration


ClinicalTrials.gov Identifier: NCT02533921.",2020,"Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months.","['584 persons with PDRD', 'persons with PDRD', 'patients with PDRD and their caregivers', 'patients with PDRD', 'Patients were excluded if they had urgent PC needs, another diagnosis meriting PC, were already receiving PC, or were unable or unwilling to follow the study protocol', 'Patients were eligible to participate if they had PDRD and moderate to high PC needs', 'Patients With Parkinson Disease and Related Disorders', '210 patients with PDRD (135 men [64.3%]; mean [SD] age, 70.1\u2009[8.2] years) and 175 caregivers (128 women [73.1%]; mean [SD] age, 66.1 [11.1] years) were enrolled in the study; 193 participants (91.9', '351 persons were excluded by phone and 23 were excluded during in-person screenings', 'participants at 3 academic tertiary care centers between November 1, 2015, and September 30, 2017, and followed them up for 1 year']","['Integrated Outpatient Palliative Care', 'standard care plus outpatient integrated PC or standard care alone', 'PC intervention']","['nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden', 'caregiver burden', 'patient quality of life (QoL; measured by the Quality of Life in Alzheimer Disease scale) and caregiver burden (measured by the Zarit Burden Interview']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0222045'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",210.0,0.101226,"Other significant differences favoring the PC intervention included nonmotor symptom burden, motor symptom severity, completion of advance directives, caregiver anxiety, and caregiver burden at 12 months.","[{'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Miyasaki', 'Affiliation': 'Department of Neurology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pantilat', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Cari', 'Initials': 'C', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Cernik', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Yuika', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Division of Palliative Medicine, Department of Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Long', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Fairclough', 'Affiliation': 'Department of Biostatistics and Informatics, School of Public Health, University of Colorado, Aurora.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado, Denver, Aurora.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Colorado, Aurora.'}]",JAMA neurology,['10.1001/jamaneurol.2019.4992']
3015,31475622,Potential for limited reinforcing and abuse-related subjective effects of intranasal oxytocin.,"BACKGROUND


There has been growing interest in using oxytocin as a pharmacotherapy for psychiatric disorders, including substance use disorder. Limited data exist regarding oxytocin's reinforcing efficacy, which is a necessary consideration for novel pharmacotherapies, especially in substance-using populations.
AIMS


This study aimed to determine the potential reinforcing effects of intranasally administered oxytocin by assessing behavioral economic demand and subjective effects.
METHODS


Healthy adults ( n  = 23) participated in a double-blind, repeated-measures, laboratory study wherein they received intranasal oxytocin (40 IU) or placebo in a randomized order across two sessions. Participants completed drug purchasing tasks at the conclusion of both sessions. Throughout both sessions, subjective and physiological effects were assessed.
RESULTS


Demand-curve analysis of purchasing tasks revealed greater median purchasing for oxytocin relative to placebo. Physiological and subjective effects did not significantly differ between oxytocin and placebo. However, a nonsignificant trend was observed for moderately greater drug liking for oxytocin relative to placebo. There was a significant, positive correlation between the difference in drug liking (between oxytocin and placebo) and the difference in lowest-price purchasing (between oxytocin and placebo).
CONCLUSIONS


These data suggest the potential for limited reinforcing and abuse-related subjective effects of intranasal oxytocin. Given the small sample, the greater drug liking of oxytocin compared to placebo, and the positive relation between demand and drug liking, it is possible that oxytocin may produce reinforcing effects in some participants. Therefore, additional studies of oxytocin reinforcement are warranted.",2020,Physiological and subjective effects did not significantly differ between oxytocin and placebo.,['Healthy adults ( n  = 23'],"['oxytocin reinforcement', 'oxytocin', 'oxytocin and placebo', 'placebo', 'intranasal oxytocin']","['Physiological and subjective effects', 'lowest-price purchasing', 'subjective and physiological effects', 'behavioral economic demand and subjective effects', 'drug liking']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",,0.52335,Physiological and subjective effects did not significantly differ between oxytocin and placebo.,"[{'ForeName': 'Sean B', 'Initials': 'SB', 'LastName': 'Dolan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Meredith S', 'Initials': 'MS', 'LastName': 'Berry', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychology, California State University, Chico, CA, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119867607']
3016,31895439,Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial.,"Importance


Among patients with ST-segment elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention (PCI), a survival benefit associated with radial access compared with femoral access remains controversial.
Objective


To assess whether there is a survival benefit when radial access is used instead of femoral access among patients with STEMI referred for primary PCI.
Design, Setting, and Participants


This multicenter, open-label, randomized clinical trial was conducted at 5 PCI centers in Canada. In total, 2292 patients with STEMI referred for primary PCI were enrolled between July 2011 and December 2018, with a 30-day follow-up. The primary analyses were conducted based on the intention-to-treat population.
Interventions


Patients were randomized to radial access (n = 1136) or to femoral access (n = 1156) for PCI.
Main Outcomes and Measures


Initially, the primary outcome was bleeding, but this outcome was modified to 30-day all-cause mortality following the recommendation of the granting agency. Secondary outcomes included recurrent myocardial infarction, stroke, and Thrombolysis in Myocardial Infarction-defined major or minor bleeding.
Results


Among the 2292 patients enrolled, the mean (SD) age of the patients randomized to radial access was 61.6 (12.3) years and to femoral access was 62.0 (12.1) years, with 883 male patients in the radial access and 901 male patients in the femoral access group. The trial was stopped early following a futility analysis. Primary PCI was performed in 1082 of 1136 patients (95.2%) in the radial access group and 1109 of 1156 patients (95.9%) in the femoral access group. Bivalirudin was administered to 1001 patients (88.1%) in the radial access group and to 1068 patients (92.4%) in the femoral access group, whereas glycoprotein IIb/IIIa inhibitors were administered in only 69 patients (6.1%) in the radial access group and 68 patients (5.9%) in the femoral access group. A vascular closure device was used in 789 patients (68.3%) in the femoral group. The primary outcome, 30-day all-cause mortality, occurred in 17 patients (1.5%) assigned to radial access and in 15 patients (1.3%) assigned to femoral access (relative risk [RR], 1.15; 95% CI, 0.58-2.30; P = .69). There were no significant differences between patients assigned to radial and femoral access in the rates of reinfarction (1.8% vs 1.6%; RR, 1.07; 95% CI, 0.57-2.00; P = .83), stroke (1.0% vs 0.4%; RR, 2.24; 95% CI, 0.78-6.42; P = .12), and bleeding (1.4% vs 2.0%; RR, 0.71; 95% CI, 0.38-1.33; P = .28).
Conclusions and Relevance


No significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI. However, small absolute differences in end points cannot be definitively refuted given the premature termination of the trial.
Trial Registration


ClinicalTrials.gov identifier: NCT01398254.",2020,"Conclusions and Relevance


No significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI.","['2292 patients enrolled, the mean (SD) age of the patients randomized to radial access was 61.6 (12.3) years and to femoral access was 62.0 (12.1) years, with 883 male patients in the radial access and 901 male patients in the femoral access group', 'patients with STEMI referred for primary PCI.\nDesign, Setting, and Participants', 'patients with ST-segment elevation myocardial infarction (STEMI) referred for primary', '5 PCI centers in Canada', '2292 patients with STEMI referred for primary PCI were enrolled between July 2011 and December 2018, with a 30-day follow-up', '789 patients (68.3%) in the femoral group', 'ST-Segment Elevation Myocardial Infarction']","['Femoral Access vs Radial Access', 'radial access (n\u2009=\u20091136) or to femoral access (n\u2009=\u20091156) for PCI', 'Bivalirudin', 'percutaneous coronary intervention (PCI']","['stroke', 'rates of reinfarction', 'Safety and Efficacy', 'survival', '30-day all-cause mortality', 'recurrent myocardial infarction, stroke, and Thrombolysis in Myocardial Infarction-defined major or minor bleeding', 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",2292.0,0.504145,"Conclusions and Relevance


No significant differences were found for survival or other clinical end points at 30 days after the use of radial access vs femoral access in patients with STEMI referred for primary PCI.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Le May', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'So', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Aun Yeong', 'Initials': 'AY', 'LastName': 'Chong', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Dick', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Froeschl', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Glover', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hibbert', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Marquis', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Blondeau', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Osborne', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'MacDougall', 'Affiliation': 'Department of Medicine, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Kass', 'Affiliation': 'Department of Medicine, St Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Paddock', 'Affiliation': 'Department of Medicine, Saint John Regional Hospital, Saint John, New Brunswick, Canada.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Quraishi', 'Affiliation': 'Department of Medicine, Queen Elizabeth II Health Science Centre, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Labinaz', 'Affiliation': 'Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}]",JAMA cardiology,['10.1001/jamacardio.2019.4852']
3017,30251255,"Optimization of Nutrition Therapy with the Use of Calorimetry to Determine and Control Energy Needs in Mechanically Ventilated Critically Ill Patients: The ONCA Study, a Randomized, Prospective Pilot Study.","BACKGROUND


Adequate nutrition therapy in critically ill patients poses a challenge because of the variable energy and substrate needs. The objective was to investigate whether nutrition therapy involving indirect calorimetry (IC), instead of equations for assessment of energy needs, could improve the nutrition status of critically ill patients.
METHODS


Forty mechanically ventilated patients were randomized into a group in which energy needs were controlled by calorimetry (IC group) and a group treated with a formula-based approach reflecting standard care (SC group). The primary outcome was change in the phase angle (PhA), a bioelectrical impedance parameter related to nutrition status and prognosis.
RESULTS


The mean IC-based energy requirement was lower than the formula-based estimate (21.1 ± 6.4 versus [vs] 25 kcal/kg/d, P < .01). The IC group reached 98% ± 8% of the energy goal, whereas the SC group reached only 79% ± 29% (P < 0.05), although mean intake was similar in both groups. The protein intake goal was better met in the IC group (91% ± 24%) than the SC group (73% ± 33%). The PhA of the IC group did not change during treatment, whereas that of the SC group tended to decrease by 0.36° ± 0.86° (P = .077). A shorter length of stay in intensive care was observed in the IC than in the SC group (13 ± 8 vs 24 ± 20 days, P < .05).
CONCLUSION


Intensified individual nutrition therapy involving IC appears to be useful for improving nutrition status in critically ill patients.",2019,"A shorter length of stay in intensive care was observed in the IC than in the SC group (13 ± 8 vs 24 ± 20 days, P < .05).
","['critically ill patients', 'Mechanically Ventilated Critically Ill Patients', 'Forty mechanically ventilated patients']","['nutrition therapy involving indirect calorimetry (IC', 'calorimetry (IC group) and a group treated with a formula-based approach reflecting standard care (SC group']","['protein intake goal', 'mean IC-based energy requirement', 'mean intake', 'shorter length of stay in intensive care', 'change in the phase angle (PhA), a bioelectrical impedance parameter related to nutrition status and prognosis']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2937349', 'cui_str': 'Nutrition Therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C0006779', 'cui_str': 'Calorimetry'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085559'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}]",40.0,0.0773352,"A shorter length of stay in intensive care was observed in the IC than in the SC group (13 ± 8 vs 24 ± 20 days, P < .05).
","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Gonzalez-Granda', 'Affiliation': 'Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Asja', 'Initials': 'A', 'LastName': 'Schollenberger', 'Affiliation': 'Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haap', 'Affiliation': 'Medical Intensive Care Unit, Department of Medicine, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Reimer', 'Initials': 'R', 'LastName': 'Riessen', 'Affiliation': 'Medical Intensive Care Unit, Department of Medicine, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stephan C', 'Initials': 'SC', 'LastName': 'Bischoff', 'Affiliation': 'Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1450']
3018,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND


Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS


Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION


Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE


",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3019,30560426,"The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial.","This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 10 9  CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (β - 13.56 mg/dL; 95% CI, - 23.82, - 3.30; P = 0.01), insulin levels (β - 5.49 μIU/mL; 95% CI, - 6.92, - 4.05; P < 0.001), and insulin resistance (β - 2.25; 95% CI, - 3.02, - 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (β 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (β - 2930.48 ng/mL; 95% CI, - 3741.15, - 2119.80; P < 0.001) and malondialdehyde levels (β - 0.60 μmol/L; 95% CI, - 0.99, - 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (β 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (β 131.11 μmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.",2019,"Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD.","['60 diabetic HD patients', 'diabetic patients undergoing hemodialysis (HD', 'Diabetic Patients Undergoing Hemodialysis', 'diabetic patients under HD']","['placebo', 'Synbiotic supplementation', 'Placebo', 'Synbiotic Supplementation', 'synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2', 'synbiotic supplementation']","['total glutathione levels', 'quantitative insulin sensitivity check index', 'insulin resistance', 'high-sensitivity C-reactive protein', 'malondialdehyde levels', 'Metabolic Status', 'metabolic profiles', 'insulin levels', 'total antioxidant capacity', 'glycemic control, biomarkers of inflammation, and oxidative stress', 'fasting plasma glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",60.0,0.756403,"Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motamedzadeh', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Zarrati Mojarrad', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Faculty member of Science department, science faculty, Islamic Azad University Tehran Central Branch, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9499-3']
3020,31825466,Effects of Mirtazapine for Methamphetamine Use Disorder Among Cisgender Men and Transgender Women Who Have Sex With Men: A Placebo-Controlled Randomized Clinical Trial.,"Importance


Methamphetamine use is increasingly prevalent and associated with HIV transmission. A previous phase 2a study of mirtazapine demonstrated reductions in methamphetamine use and sexual risk behaviors among men who have sex with men.
Objective


To determine the efficacy of mirtazapine for treatment of methamphetamine use disorder and reduction in HIV risk behaviors.
Design, Setting, and Participants


This double-blind randomized clinical trial of mirtazapine vs placebo took place from August 2013 to September 2017 in an outpatient research clinic in San Francisco, California. Participants were community-recruited adults who were sexually active; cisgender men, transgender men, and transgender women who (1) had sex with men, (2) had methamphetamine use disorder, and (3) were actively using methamphetamine were eligible. Participants were randomized to receive the study drug or placebo for 24 weeks, with 12 more weeks of follow-up. Data analysis took place from February to June 2018.
Exposures


Mirtazapine, 30 mg, or matched placebo orally once daily for 24 weeks, with background counseling.
Main Outcomes and Measures


Positive urine test results for methamphetamine over 12, 24, and 36 weeks (primary outcomes) and sexual risk behaviors (secondary outcomes). Sleep, methamphetamine craving, dependence severity, and adverse events were assessed.
Results


Of 241 persons assessed, 120 were enrolled (5 transgender women and 115 cisgender men). The mean (SD) age was 43.3 (9.8) years; 61 (50.8%) were white, 31 (25.8%) were African American, and 15 (12.5%) were Latinx. A mean (SD) of 66% (47%) of visits were completed overall. By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]). Mirtazapine resulted in reductions in positive urine test results at 24 weeks (RR, 0.75 [95% CI, 0.56-1.00]) and 36 weeks (RR, 0.73 [95% CI, 0.57-0.96]) vs placebo. Mean (SD) medication adherence by WisePill dispenser was 38.5% (27.0%) in the mirtazapine group vs 39.5% (26.2%) in the placebo group (P = .77) over 2 to 12 weeks and 28.1% (23.4%) vs 38.5% (27.0%) (P = .59) over 13 to 24 weeks. Changes in sexual risk behaviors were not significantly different by study arm at 12 weeks, but those assigned to receive mirtazapine had fewer sexual partners (RR, 0.52 [95% CI, 0.27-0.97]; P = .04), fewer episodes of condomless anal sex with partners who were serodiscordant (RR, 0.47 [95% CI, 0.23-0.97]; P = .04), and fewer episodes of condomless receptive anal sex with partners who were serodiscordant (RR, 0.37 [95% CI, 0.14-0.93]; P = .04) at week 24. Participants assigned to mirtazapine had net reductions in depressive symptoms (Center for Epidemiologic Studies Depression Scale score, 6.2 [95% CI, 1.3-11.1] points lower; P = .01) and insomnia severity (Athens score, 1.4 [95% CI, 0.1-2.7] points lower; P = .04) at week 24. There were no serious adverse events associated with the study drug.
Conclusions and Relevance


In this expanded replication trial, adding mirtazapine to substance use counseling reduced methamphetamine use and some HIV risk behaviors among cisgender men and transgender women who have sex with men, with benefits extending after treatment despite suboptimal medication adherence.
Trial Registration


ClinicalTrials.gov identifier: NCT01888835.",2020,"By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]).","['The mean (SD) age was 43.3 (9.8) years; 61 (50.8%) were white, 31 (25.8%) were African American, and 15 (12.5%) were Latinx', 'men who have sex with men', '241 persons assessed, 120 were enrolled (5 transgender women and 115 cisgender men', 'cisgender men and transgender women who have sex with men', 'August 2013 to September 2017 in an outpatient research clinic in San Francisco, California', 'Participants were community-recruited adults who were sexually active; cisgender men, transgender men, and transgender women who (1) had sex with men, (2) had methamphetamine use disorder, and (3) were actively using methamphetamine were eligible', 'Cisgender Men and Transgender Women']","['Placebo', 'Mirtazapine, 30 mg, or matched placebo', 'mirtazapine vs placebo', 'methamphetamine', 'placebo', 'Methamphetamine', 'Mirtazapine', 'mirtazapine']","['methamphetamine use and sexual risk behaviors', 'rate of methamphetamine-positive urine test', 'Sleep, methamphetamine craving, dependence severity, and adverse events', 'serious adverse events', 'Mean (SD) medication adherence by WisePill dispenser', 'positive urine test results', 'depressive symptoms (Center for Epidemiologic Studies Depression Scale score', 'HIV risk behaviors', 'sexual partners', 'sexual risk behaviors', 'episodes of condomless anal sex', 'insomnia severity', 'episodes of condomless receptive anal sex']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}]","[{'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3540005', 'cui_str': 'URINE TESTS'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",120.0,0.70042,"By week 12, the rate of methamphetamine-positive urine test results significantly declined among participants randomized to mirtazapine vs placebo (risk ratio [RR], 0.67 [95% CI, 0.51-0.87]).","[{'ForeName': 'Phillip O', 'Initials': 'PO', 'LastName': 'Coffin', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Glenn-Milo', 'Initials': 'GM', 'LastName': 'Santos', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Hern', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Walker', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Matheson', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': 'Santos', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Colfax', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, California.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Batki', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.3655']
3021,31170845,Risk factors associated with prolonged neonatal intensive care unit stay after threatened late preterm birth.,"Objective:  To identify risk factors associated with neonatal intermediate or intensive care unit (NICU) stay ≥3 days among women with threatened late preterm birth (PTB).  Study design:  Secondary analysis of women with nonanomalous, singleton gestations enrolled in multicenter trial of betamethasone versus placebo for late PTB. Maternal and obstetric characteristics at time of presentation with threatened PTB were compared between those with and without NICU stay ≥3 days. Multivariable logistic regression identified risk factors for NICU stay ≥3 days.  Result:  Of 2795 eligible mother-neonate dyads, 962 (34%) had NICU stay ≥3 days. Gestational age and fetal growth restriction as the reason for threatened PTB had the strongest association with NICU stay ≥3 days in the final model (AUC 0.76).  Conclusion:  Maternal and obstetric characteristics at the time of admission for threatened late PTB should be considered when counseling patients about the probability of NICU stay ≥3 days.",2019,Gestational age and fetal growth restriction as the reason for threatened PTB had the strongest association with NICU stay ≥3 days in the final model (AUC 0.76).  ,"['2795 eligible mother-neonate dyads', 'women with threatened late preterm birth (PTB', 'women with nonanomalous, singleton gestations enrolled in multicenter trial of']","['betamethasone', 'neonatal intermediate or intensive care unit (NICU) stay ≥3\xa0days', 'placebo']","['Maternal and obstetric characteristics', 'Gestational age and fetal growth restriction']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}]",2795.0,0.0780269,Gestational age and fetal growth restriction as the reason for threatened PTB had the strongest association with NICU stay ≥3 days in the final model (AUC 0.76).  ,"[{'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Battarbee', 'Affiliation': 'a Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'Angelica V', 'Initials': 'AV', 'LastName': 'Glover', 'Affiliation': 'a Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Vladutiu', 'Affiliation': 'a Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gyamfi-Bannerman', 'Affiliation': 'b Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology , Columbia University Medical Center , New York , NY , USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Aliaga', 'Affiliation': 'c Division of Neonatology, Department of Pediatrics , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Manuck', 'Affiliation': 'a Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Boggess', 'Affiliation': 'a Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology , University of North Carolina School of Medicine , Chapel Hill , NC , USA.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1623777']
3022,31895407,Association Between Immune-Related Adverse Events and Recurrence-Free Survival Among Patients With Stage III Melanoma Randomized to Receive Pembrolizumab or Placebo: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Whether immune-related adverse events (irAEs) indicate drug activity in patients treated with immune checkpoint inhibitors remains unknown.
Objective


To investigate the association between irAEs and recurrence-free survival (RFS) in the double-blind EORTC 1325/KEYNOTE-054 clinical trial comparing pembrolizumab therapy and placebo for the treatment of patients with high-risk stage III melanoma.
Design, Setting, and Participants


A total of 1019 adults with stage III melanoma were randomly assigned on a 1:1 ratio to receive treatment with pembrolizumab therapy or placebo. Eligible patients were adults 18 years and older with complete resection of cutaneous melanoma metastatic to lymph nodes, classified with stage IIIA (at least 1 micrometastasis measuring >1 mm in greatest diameter), IIIB, or IIIC (without in-transit metastasis) cancer. Patients were randomized from August 26, 2015, to November 14, 2016. The clinical cutoff for the data set was October 2, 2017. Analyses were then performed on the database, which was locked on November 28, 2017.
Interventions


Participants were scheduled to receive 200 mg of pembrolizumab or placebo every 3 weeks for a total of 18 doses for approximately 1 year or until disease recurrence, unacceptable toxic effects, major protocol violation, or withdrawal of consent.
Main Outcomes and Measures


The association between irAEs and RFS was estimated using a Cox model adjusted for sex, age, and AJCC-7 stage, with a time-varying covariate that had a value of 0 before irAE onset and 1 after irAE onset.
Results


Of 1011 patients who began treatment with pembrolizumab therapy or placebo, 622 (61.5%) were men and 389 (38.5%) were women; 386 patients (38.2%) were aged 50 to 64 years, 377 (37.3%) were younger than 50 years, and 248 (24.5%) were 65 years and older. Consistent with the reported main analysis in the intent-to-treat population, RFS was longer in the pembrolizumab arm compared with the placebo arm (hazard ratio [HR], 0.56; 98.4% CI, 0.43-0.74) among patients who started treatment. The incidence of irAEs was 190 (37.4%) in the pembrolizumab arm (n = 509) and 45 (9.0%) in the placebo arm (n = 502); in each treatment group, the incidence was similar for men and women. The occurrence of an irAE was associated with a longer RFS in the pembrolizumab arm (HR, 0.61; 95% CI, 0.39-0.95; P = .03) in both men and women. However, in the placebo arm, this association was not significant. Compared with the placebo arm, the reduction in the hazard of recurrence or death in the pembrolizumab arm was greater after the onset of an irAE than without or before an irAE (HR, 0.37; 95% CI, 0.24-0.57 vs HR, 0.61; 95% CI, 0.49-0.77, respectively; P = .03).
Conclusions and Relevance


In this study, the occurrence of an irAE was associated with a longer RFS in the pembrolizumab arm.
Trial Registrations


ClinicalTrials.gov identifier: NCT02362594; EudraCT identifier: 2014-004944-37.",2020,"Compared with the placebo arm, the reduction in the hazard of recurrence or death in the pembrolizumab arm was greater after the onset of an irAE than without or before an irAE (HR, 0.37; 95% CI, 0.24-0.57 vs HR, 0.61; 95% CI, 0.49-0.77, respectively; P = .03).
","['Eligible patients were adults 18 years and older with complete resection of cutaneous melanoma metastatic to lymph nodes, classified with stage IIIA (at least 1 micrometastasis measuring >1 mm in greatest diameter), IIIB, or IIIC (without in-transit metastasis) cancer', 'Patients were randomized from August 26, 2015, to November 14, 2016', 'Patients With Stage III Melanoma', '1011 patients who began treatment with pembrolizumab therapy or placebo, 622 (61.5%) were men and 389 (38.5%) were women; 386 patients (38.2%) were aged 50 to 64 years, 377 (37.3%) were younger than 50 years, and 248 (24.5%) were 65 years and older', 'patients treated with immune checkpoint inhibitors remains unknown', '1019 adults with stage III melanoma', 'patients with high-risk stage III melanoma']","['pembrolizumab', 'pembrolizumab therapy or placebo', 'pembrolizumab or placebo', 'placebo', 'Pembrolizumab or Placebo', 'pembrolizumab therapy and placebo']","['hazard of recurrence or death', 'incidence of irAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C1513276', 'cui_str': 'Micrometastasis'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0450317', 'cui_str': '1011'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517752', 'cui_str': '389 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0450318', 'cui_str': '1019'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",1019.0,0.739525,"Compared with the placebo arm, the reduction in the hazard of recurrence or death in the pembrolizumab arm was greater after the onset of an irAE than without or before an irAE (HR, 0.37; 95% CI, 0.24-0.57 vs HR, 0.61; 95% CI, 0.49-0.77, respectively; P = .03).
","[{'ForeName': 'Alexander M M', 'Initials': 'AMM', 'LastName': 'Eggermont', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Universite Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kicinski', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Mandala', 'Affiliation': 'Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney and Mater and Royal North Shore Hospitals, Sydney, New South Wales, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Atkinson', 'Affiliation': 'Princess Alexandra Hospital, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils de Lyon Cancer Institute, Lyon University, Lyon, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Fiona Stanley Hospital, University of Western Australia, Perth, Washington, Australia.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia and the University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Shahneen', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Puig', 'Affiliation': 'Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Sklodowska-Curie Institute Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Koornstra', 'Affiliation': 'Radboud University Medical Center Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'Leonel', 'Initials': 'L', 'LastName': 'Hernandez-Aya', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Di Giacomo', 'Affiliation': 'Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy.'}, {'ForeName': 'Alfonsus J M', 'Initials': 'AJM', 'LastName': 'van den Eertwegh', 'Affiliation': 'Vrije Universiteit Medical Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Hopital de la Timone, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Rahima', 'Initials': 'R', 'LastName': 'Jamal', 'Affiliation': ""Centre de Recherche, Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Lorigan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, New Jersey.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, New Jersey.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'van Akkooi', 'Affiliation': 'Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Cancer Campus Grand Paris, Universite Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}]",JAMA oncology,['10.1001/jamaoncol.2019.5570']
3023,31404668,Safety of Reslizumab in Uncontrolled Asthma with Eosinophilia: A Pooled Analysis from 6 Trials.,"BACKGROUND


Intravenous reslizumab, a monoclonal IL-5 antibody, is approved for treating severe asthma with eosinophilia. Limited structured information is available on the safety of reslizumab in larger populations.
OBJECTIVE


To investigate the safety profile of intravenous reslizumab 3.0 mg/kg by analyzing data from 6 asthma clinical trials: 5 placebo-controlled (duration ≤52 weeks) and 1 open-label extension (up to 2 years of treatment).
METHODS


Patients were aged 12 to 75 years with inadequately controlled asthma with eosinophilia. In the placebo-controlled trials, 730 patients received placebo and 1028 received reslizumab 3.0 mg/kg.
RESULTS


Adverse events (AEs) and serious AEs occurred in higher percentages of patients in the placebo group (81% and 9%) than in the reslizumab group (67% and 6%). Asthma, nasopharyngitis, and upper respiratory tract infection were the most common AEs with placebo and reslizumab. Three cases of anaphylaxis, related to reslizumab, were successfully managed with standard therapies. No significant difference in the incidence of malignancies was seen when compared with placebo or the general population. Among 756 patients with more than 12 months of reslizumab exposure, the AE rate was lower than in the placebo-controlled trials (367.3 vs 433.9 events/100 patient-years). The incidence of AEs in patients on treatment for more than 12 months was no higher than in patients with shorter treatment durations.
CONCLUSIONS


This analysis confirms that treatment with intravenous reslizumab for more than 12 months is well tolerated in patients with asthma, with no evidence of rare safety events that were not detected in individual trials.",2020,"Asthma, nasopharyngitis and upper respiratory tract infection were the most common AEs with placebo and reslizumab.","['Patients were aged 12-75 years with inadequately controlled asthma with eosinophilia', 'patients with asthma', 'uncontrolled asthma with eosinophilia', '756 patients with >12 months of reslizumab exposure, the', 'severe asthma with eosinophilia', '730 patients received']","['intravenous reslizumab', 'reslizumab', 'placebo', 'placebo-controlled (duration ≤52 weeks) and one open-label extension', 'placebo and 1028 reslizumab 3.0 mg/kg']","['incidence of malignancies', 'Asthma, nasopharyngitis and upper respiratory tract infection', 'AE rate', 'Adverse events (AEs) and serious AEs', 'incidence of AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",730.0,0.406541,"Asthma, nasopharyngitis and upper respiratory tract infection were the most common AEs with placebo and reslizumab.","[{'ForeName': 'J Christian', 'Initials': 'JC', 'LastName': 'Virchow', 'Affiliation': 'Department of Pneumology/Intensive Care Medicine, University of Rostock, Rostock, Germany. Electronic address: j.c.virchow@med.uni-rostock.de.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Katial', 'Affiliation': 'Division of Allergy and Immunology, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Guy G', 'Initials': 'GG', 'LastName': 'Brusselle', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium; Department of Epidemiology, Erasmus Medical Center, Rotterdam, The Netherlands; Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Shalit', 'Affiliation': 'Teva Pharmaceuticals, Netanya, Israel.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Garin', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc, Malvern, Pa.'}, {'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'McDonald', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc, Malvern, Pa.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Medicine, Pediatrics, and Radiology, Washington University School of Medicine, St Louis, Mo.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.07.038']
3024,32024498,"Influence of ozonized water on pain, oedema, and trismus during impacted third molar surgery: a randomized, triple blind clinical trial.","BACKGROUND


This study aimed to evaluate the efficacy of ozonized water on pain, oedema and trismus after impacted third molar mandibular surgeries when compared to double distilled water. A randomized triple blind trial was conducted.
METHODS


Patients with third molars class II-B of Pell-Gregory were included, and surgical extraction was performed. Irrigation was done with ozonized (group 1) or double distilled water (group 2). The type of irrigation and the side to be operated were randomized. Neither the patients nor the operator or evaluator were aware of the irrigation solution. Pain, oedema and trismus were evaluated at baseline, 24-h, 48-h, 72-h and 7-days after treatment. The data were evaluated by Friedman, Wilcoxon, Mann-Whitney tests, and size effect.
RESULTS


It was included 8 men and 12 women, with a mean age of 20.9y.o. The initial pain mean was 7.94 (±12.81) (group 1) and 5.50 (±9.12) (group 2) (p > 0,05). There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05). There was no statistically significant difference (p > 0.05) when comparing the oedema and trismus between groups. The size effect ranged from small (0.23) to large (1.29).
CONCLUSIONS


It was concluded that ozonized water was compatible as irrigation method, not inferior to double distilled water, and had satisfactory effects on management of pain, oedema and trismus after surgical removal of the third molar.
TRIAL REGISTRATION


This clinical trial was registered in ClinicalTrials.gov NCT03501225 on April 18, 2018.",2020,"There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05).","['It was included 8 men and 12 women, with a mean age of 20.9y.o', 'Patients with third molars class II-B of Pell-Gregory were included, and surgical extraction was performed', 'during impacted third molar surgery']","['ozonized (group 1) or double distilled water', 'ozonized water']","['initial pain mean', 'Pain, oedema and trismus', 'oedema and trismus', 'pain, oedema, and trismus', 'pain, oedema and trismus']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",,0.271193,"There was a statistically significant reduction of pain, oedema and trismus in intragroup analysis (p < 0.05).","[{'ForeName': 'José Cristiano Ramos', 'Initials': 'JCR', 'LastName': 'Glória', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Dhelfeson Willya', 'Initials': 'DW', 'LastName': 'Douglas-de-Oliveira', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil. dhelfeson@hotmail.com.'}, {'ForeName': 'Larissa Doalla Almeida', 'Initials': 'LDA', 'LastName': 'E Silva', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Saulo Gabriel Moreira', 'Initials': 'SGM', 'LastName': 'Falci', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}, {'ForeName': 'Cássio Roberto Rocha', 'Initials': 'CRR', 'LastName': 'Dos Santos', 'Affiliation': 'Departament of Dentistry, Faculty of Biologic Sciences and Health, Federal University of Jequitinhonha and Mucuri Valleys, Rua da Glória, 187, Centro, Diamantina, Minas Gerais, Brazil.'}]",BMC oral health,['10.1186/s12903-020-1029-5']
3025,32030525,"A Pilot Test of Game Changers, a Social Network Intervention to Empower People with HIV to be Prevention Advocates in Uganda.","We conducted a pilot randomized controlled trial of Game Changers, a 6-session group intervention that empowers people with HIV to be HIV prevention advocates in their social networks. Ninety-nine people with HIV (51 intervention, 48 wait-list control) and 58 of their social network members (alters) completed baseline and 5- and 8-month post-baseline assessments. Results indicated high acceptability, demonstrated by participants' and facilitators' positive attitudes qualitatively and favorable ratings of intervention sessions quantitatively, and high feasibility (76% attended all intervention sessions). Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08]. Positioning people with HIV as central to prevention has the potential to reduce stigma and improve prevention outcomes throughout social networks.",2020,"Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08].","['Ninety-nine people with HIV (51 intervention, 48 wait-list control) and 58 of their social network members (alters) completed baseline and 5- and 8-month post-baseline assessments', 'empowers people with HIV to be HIV prevention advocates in their social networks', 'Empower People with HIV to be Prevention Advocates in Uganda']","['6-session group intervention', 'Game Changers, a Social Network Intervention']","['HIV-serostatus disclosure', 'HIV prevention advocacy', 'internalized HIV stigma', 'social network density']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",99.0,0.0801244,"Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08].","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bogart', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA. lbogart@rand.org.'}, {'ForeName': 'Joseph K B', 'Initials': 'JKB', 'LastName': 'Matovu', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Wagner', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Harold D', 'Initials': 'HD', 'LastName': 'Green', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Storholm', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Marsh', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacCarthy', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kambugu', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda.'}]",AIDS and behavior,['10.1007/s10461-020-02806-4']
3026,31928489,Participant Perceptions on a Fitbit and Facebook Intervention for Young Adult Cancer Survivors: A Qualitative Study.,"Purpose:  Among cancer survivors, physical activity (PA) is associated with reductions in cancer recurrence, morbidity, and mortality. Most young adult (YA) survivors do not attain adequate PA. Digital modalities, specifically wearable activity monitors with a paired mobile application and private social media group for support offer a promising approach for promoting PA among YAs. We conducted a pilot randomized controlled trial of this intervention. To evaluate its acceptability and perceptions of the intervention components, we conducted qualitative interviews with those in the intervention. The results of our interviews serve to refine future interventions to better serve this population.  Methods:  Semistructured qualitative interviews with 13 YA cancer survivors ages 20-39 who participated in the intervention assessed perceptions of the digital components of the study and buddy system of nominating a friend to participate in PA with the survivor. Analyses included a qualitative thematic analysis of the interview transcripts and coded interview segments into three predetermined categories: facilitators, limitations, and suggestions.  Results:  Participants described wide-ranging benefits of the intervention, citing the Fitbit device and buddy system as major motivators to engage in PA and reach goals. Most participants noted feelings of increased physical and emotional wellness. The most-cited limitation of the intervention was the automated text messages, which participants found impersonal. Suggestions for improvement included integrating more elements of competition and group challenges.  Conclusion:  This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life. Clinicaltrial.gov identifier number: NCT03233581; Date of registration: July 28, 2017.",2020,This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life.,"['13 YA cancer survivors ages 20-39 who participated in the intervention assessed perceptions of the digital components of the study and buddy system of nominating a friend to participate in PA with the survivor', 'Young Adult Cancer Survivors', 'Clinicaltrial.gov identifier number', 'Most young adult ']","['Fitbit and Facebook Intervention', 'digital PA intervention']","['cancer recurrence, morbidity, and mortality', 'feelings of increased physical and emotional wellness']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",,0.0607168,This digital PA intervention was perceived as feasible and acceptable to YA cancer survivors and appears promising for promoting PA and improving long-term health and quality of life.,"[{'ForeName': 'Evelina M', 'Initials': 'EM', 'LastName': 'Miropolsky', 'Affiliation': 'Nutritional Sciences Program, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Scott Baker', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Syrjala', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Chow', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ceballos', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': 'Nutritional Sciences Program, University of Washington, Seattle, Washington, USA.'}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2019.0072']
3027,31648008,Muscle quality and functionality in older women improve similarly with muscle power training using one or three sets.,"The present study compared the effects of 12 weeks of muscle power training performing one or three sets on muscle quality assessed by echo intensity (MQ EI ) and index (MQ index ), muscle power-related outcomes, and functional capacity in older women. Participants were randomly assigned into two groups: 1SET (n = 13) and 3SET (n = 13). Lower limb muscle power and vertical jump height were measured during a countermovement jump, maximal rate of torque development (MRTD), and root mean square (RMS) of electromyography signals and rate of rise (RER) of quadriceps maximal electromyography activation during unilateral knee extension at 0-50 and 0-200 ms, MQ EI , MQ index  (absolute muscle power/MQ EI , and MRTD/MQ EI ) and functionally in both groups using timed-up-and-go were evaluated before and after training. There were significant and similar (p < 0.05) increases in muscle power, vertical jump height, MQ EI , MQ index,  and functionally (p ≤ 0.0001) in both groups. In contrast, MRTD increased only in 1SET (p ≤ 0.001), and the RMS 0 - 200  and RER 0 - 50  increased for 3SET only (p ≤ 0.05), with no difference between groups (p > 0.05). In conclusion, similar neuromuscular adaptations and improvements in the functional performance occurred in both groups.",2019,"There were significant and similar (p < 0.05) increases in muscle power, vertical jump height, MQ EI , MQ index,  and functionally (p ≤ 0.0001) in both groups.",['older women'],"['1SET', '3SET']","['functional performance', 'neuromuscular adaptations', 'muscle quality assessed by echo intensity (MQ EI ) and index (MQ index ), muscle power-related outcomes, and functional capacity', 'Lower limb muscle power and vertical jump height', 'Muscle quality and functionality', 'muscle power, vertical jump height, MQ EI , MQ index,  and functionally', 'RMS 0-200  and RER 0-50  increased for 3SET', 'countermovement jump, maximal rate of torque development (MRTD), and root mean square (RMS) of electromyography signals and rate of rise (RER) of quadriceps maximal electromyography activation during unilateral knee extension at 0-50 and 0-200\u202fms, MQ EI , MQ index  (absolute muscle power/MQ EI , and MRTD/MQ EI ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C3853978'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",,0.0183414,"There were significant and similar (p < 0.05) increases in muscle power, vertical jump height, MQ EI , MQ index,  and functionally (p ≤ 0.0001) in both groups.","[{'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: regis.radaelli@hotmail.com.'}, {'ForeName': 'Clarissa M', 'Initials': 'CM', 'LastName': 'Brusco', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Department of Physical Education, Universidade de Caxias do Sul, Caxias do Sul, RS, Brazil.'}, {'ForeName': 'Carlos L F', 'Initials': 'CLF', 'LastName': 'Machado', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Diana C', 'Initials': 'DC', 'LastName': 'Müller', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Tufano', 'Affiliation': 'Charles University in Prague, Faculty of Physical Education and Sport, Czechia.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ronei S', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'Exercise Research Laboratory, Physical Education, Physiotherapy and Dance School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2019.110745']
3028,32023535,Association of Decline in Physical Activity With Increased Negative Mood Following the Weight-Loss Phase in Women Enrolled in a Cognitive Behavioral Obesity Treatment.,"BACKGROUND


Physical activity (PA)-related mood improvement is important because it positively affects predictors of weight-management behaviors.
METHODS


Decline in PA, mood, and exercise self-efficacy after an initial 6 months of gains were assessed in 93 women in a behavioral obesity treatment.
RESULTS


Reduction in change in PA during months 6 to 24, but not actual PA, significantly predicted increased negative mood. For participants whose negative mood increased, their 7 days per week PA regimens were reduced by ∼2.5 days per week versus ∼1 day per week without an increase. Exercise self-efficacy significantly mediated the PA-mood change relationship.
CONCLUSIONS


Mood-related benefits of sustaining PA beyond initial treatment months were clarified.",2020,"For participants whose negative mood increased, their 7 days per week PA regimens were reduced by ∼2.5 days per week versus ∼1 day per week without an increase.","['93 women in a behavioral obesity treatment', 'Women']",['Cognitive Behavioral Obesity Treatment'],"['Exercise self-efficacy', 'Physical Activity', 'negative mood', 'PA, mood, and exercise self-efficacy', 'Negative Mood']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",93.0,0.0219379,"For participants whose negative mood increased, their 7 days per week PA regimens were reduced by ∼2.5 days per week versus ∼1 day per week without an increase.","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0436']
3029,31030774,Comparison of visual and refractive outcomes between hydrophilic and hydrophobic trifocal intraocular lenses sharing the same optical design.,"PURPOSE


To compare clinical outcomes between two trifocal intraocular lenses (IOLs): the new FineVision POD F GF trifocal IOL made of hydrophobic acrylic glistening-free material, and the FineVision POD F IOL made of hydrophilic acrylic material with 26% water uptake in patients undergoing routine cataract surgery using standard phacoemulsification.
SETTING


Semmelweis University, Department of Ophthalmology, Budapest, Hungary.
DESIGN


Prospective controlled randomized single-center single-surgeon study.
METHODS


Each patient had the hydrophilic POD F IOL implanted in one eye and the hydrophobic POD F GF IOL in the contralateral eye, according to a randomization table. Clinical outcomes included distance (4 m), intermediate (70 cm), and near (35 cm) visual acuities, contrast sensitivity measured under photopic and mesopic conditions, and defocus curves under photopic conditions. The follow-up was 6 months.
RESULTS


The study comprised 25 patients. Under photopic conditions, there was no statistically significant difference between POD F GF and POD F IOLs for uncorrected distance (UDVA) (P = .607), uncorrected intermediate (UIVA) (P = .491), and uncorrected near (UNVA) (P = .414) visual acuities. Under mesopic conditions, there was no statistically significant differences between the 2 IOLs for UDVA (P = 1.00), UIVA (P = .149), and UNVA (P = .551). No statistically significant differences in contrast sensitivity were found between the groups under photopic (P = .4347) and mesopic (P = .425) conditions. No safety issues were reported.
CONCLUSION


The study demonstrated equally good visual and refractive outcomes for the POD F GF IOL and the POD F IOL, giving the surgeon the option to choose the preferred material for the individual patient without compromising clinical outcomes.",2019,No statistically significant differences in contrast sensitivity were found between the groups under photopic (P = .4347) and mesopic (P = .425) conditions.,"['patients undergoing routine cataract surgery using standard phacoemulsification', 'Semmelweis University, Department of Ophthalmology, Budapest, Hungary', '25 patients']","['hydrophilic and hydrophobic trifocal intraocular lenses', 'POD F\xa0GF IOL and the POD F IOL', 'trifocal intraocular lenses (IOLs', 'hydrophilic POD F IOL implanted in one eye and the hydrophobic POD F\xa0GF IOL']","['contrast sensitivity', 'POD F\xa0GF and POD F IOLs for uncorrected distance (UDVA', 'visual acuities', 'distance (4\xa0m), intermediate (70\xa0cm), and near (35\xa0cm) visual acuities, contrast sensitivity measured under photopic and mesopic conditions, and defocus curves under photopic conditions', 'uncorrected intermediate (UIVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}]","[{'cui': 'C0475370', 'cui_str': 'Hydrophilicity'}, {'cui': 'C1275646', 'cui_str': 'Trifocals'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0242336,No statistically significant differences in contrast sensitivity were found between the groups under photopic (P = .4347) and mesopic (P = .425) conditions.,"[{'ForeName': 'Zoltan Z', 'Initials': 'ZZ', 'LastName': 'Nagy', 'Affiliation': 'Semmelweis University, Department of Ophthalmology, Budapest, Hungary. Electronic address: zoltan.nagy100@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Popper-Sachetti', 'Affiliation': 'Semmelweis University, Department of Ophthalmology, Budapest, Hungary.'}, {'ForeName': 'Huba J', 'Initials': 'HJ', 'LastName': 'Kiss', 'Affiliation': 'Semmelweis University, Department of Ophthalmology, Budapest, Hungary.'}]",Journal of cataract and refractive surgery,['10.1016/j.jcrs.2018.11.034']
3030,32033773,Incoming residents' knot-tying and suturing skills: Are medical school boot camps sufficient?,"INTRODUCTION


Many medical schools offer M4 boot camps to improve students' preparedness for surgical residencies. For three consecutive years, we investigated the impact of medical school boot camps on intern knot-tying and suturing skills when measured at the start of residency.
METHODS


Forty-two interns completed questionnaires regarding their boot camp experiences. Their performance on knot-tying and suturing exercises was scored by three surgeons blinded to the questionnaire results. A comparison of these scores of interns with or without boot camp experiences was performed and statistical analysis applied.
RESULTS


26 of 42 (62%) interns reported boot camp training. There were no differences in scores between interns with or without a M4 boot camp experience for suturing [9.6(4.6) vs 9.8(4.1), p < 0.908], knot-tying [9.1(3.6) vs 8.4(4.1), p = 0.574], overall performance [2.0(0.6) vs 1.9(0.7), p = 0.424], and quality [2.0(0.6) vs 1.9(0.7), p = 0.665]) (mean(SD)).
CONCLUSIONS


We could not demonstrate a statistically significant benefit in knot-tying and suturing skills of students who enrolled in M4 boot camp courses as measured at the start of surgical residency.",2020,We could not demonstrate a statistically significant benefit in knot-tying and suturing skills of students who enrolled in M4 boot camp courses as measured at the start of surgical residency.,['Forty-two interns completed questionnaires regarding their boot camp experiences'],"['knot-tying and suturing skills', 'knot-tying and suturing exercises']",['knot-tying and suturing skills'],"[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}]",,0.0182404,We could not demonstrate a statistically significant benefit in knot-tying and suturing skills of students who enrolled in M4 boot camp courses as measured at the start of surgical residency.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Redlich', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA; Division of Surgical Care, Clement J. Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI, 53295, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Treat', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Matthew I', 'Initials': 'MI', 'LastName': 'Goldblatt', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Carver', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Dodgion', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Peschman', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Davis', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Alizadegan', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Grushka', 'Affiliation': 'Montreal General Hospital, 1650 Cedar Avenue,L9.424, Montreal, QC, H3G 1A4, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Olson', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Krausert', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA; Division of Surgical Care, Clement J. Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI, 53295, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Malinowski', 'Affiliation': 'Department of Surgery, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA; Division of Surgical Care, Clement J. Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI, 53295, USA. Electronic address: mmalinowski@mcw.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.01.031']
3031,32029126,Coronary CT Angiography in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome.,"BACKGROUND


In patients with non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary pathology may range from structurally normal vessels to severe coronary artery disease.
OBJECTIVES


The purpose of this study was to test if coronary computed tomography angiography (CTA) may be used to exclude coronary artery stenosis ≥50% in patients with NSTEACS.
METHODS


The VERDICT (Very Early Versus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes) trial (NCT02061891) evaluated the outcome of patients with confirmed NSTEACS randomized 1:1 to very early (within 12 h) or standard (48 to 72 h) invasive coronary angiography (ICA). As an observational component of the trial, a clinically blinded coronary CTA was conducted prior to ICA in both groups. The primary endpoint was the ability of coronary CTA to rule out coronary artery stenosis (≥50% stenosis) in the entire population, expressed as the negative predictive value (NPV), using ICA as the reference standard.
RESULTS


Coronary CTA was conducted in 1,023 patients-very early, 2.5 h (interquartile range [IQR]: 1.8 to 4.2 h), n = 583; and standard, 59.9 h (IQR: 38.9 to 86.7 h); n = 440 after the diagnosis of NSTEACS was made. A coronary stenosis ≥50% was found by coronary CTA in 68.9% and by ICA in 67.4% of the patients. Per-patient NPV of coronary CTA was 90.9% (95% confidence interval [CI]: 86.8% to 94.1%) and the positive predictive value, sensitivity, and specificity were 87.9% (95% CI: 85.3% to 90.1%), 96.5% (95% CI: 94.9% to 97.8%) and 72.4% (95% CI: 67.2% to 77.1%), respectively. NPV was not influenced by patient characteristics or clinical risk profile and was similar in the very early and the standard strategy group.
CONCLUSIONS


Coronary CTA has a high diagnostic accuracy to rule out clinically significant coronary artery disease in patients with NSTEACS.",2020,"NPV was not influenced by patient characteristics or clinical risk profile and was similar in the very early and the standard strategy group.
","['patients with non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary pathology may range from structurally normal vessels to severe coronary artery disease', 'patients with NSTEACS', '1,023 patients-very early, 2.5\xa0h (interquartile range [IQR]: 1.8 to 4.2 h), n\xa0=\xa0583; and standard, 59.9\xa0h (IQR: 38.9 to 86.7 h); n\xa0', 'Patients With Non-ST-Segment Elevation Acute Coronary\xa0Syndrome', 'Patients With Acute Coronary Syndromes']","['coronary computed tomography angiography (CTA', 'invasive coronary angiography (ICA', 'Coronary CT Angiography', 'VERDICT ', 'Very Early Versus Deferred Invasive Evaluation Using Computerized Tomography']","['ability of coronary CTA to rule out coronary artery stenosis', 'positive predictive value, sensitivity, and specificity', 'coronary CTA', 'negative predictive value (NPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]",1023.0,0.0601611,"NPV was not influenced by patient characteristics or clinical risk profile and was similar in the very early and the standard strategy group.
","[{'ForeName': 'Jesper J', 'Initials': 'JJ', 'LastName': 'Linde', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per E', 'Initials': 'PE', 'LastName': 'Sigvardsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bech', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Heitmann', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Olav W', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Kühl', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Ilan E', 'Initials': 'IE', 'LastName': 'Raymond', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ole P', 'Initials': 'OP', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ida H', 'Initials': 'IH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria H D', 'Initials': 'MHD', 'LastName': 'Vall-Lamora', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Kragelund', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'de Knegt', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Hove', 'Affiliation': 'Department of Cardiology, Hvidovre and Amager Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tem', 'Initials': 'T', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Hvidovre and Amager Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gitte G', 'Initials': 'GG', 'LastName': 'Fornitz', 'Affiliation': 'Department of Cardiology, Hvidovre and Amager Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Steffensen', 'Affiliation': 'Department of Cardiology, Hillerød Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Jurlander', 'Affiliation': 'Department of Cardiology, Hillerød Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jawdat', 'Initials': 'J', 'LastName': 'Abdulla', 'Affiliation': 'Department of Cardiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Lyngbæk', 'Affiliation': 'Department of Cardiology, Glostrup Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Elming', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Susette K', 'Initials': 'SK', 'LastName': 'Therkelsen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Slagelse & Holbæk, Roskilde, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Kløvgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lia Evi', 'Initials': 'LE', 'LastName': 'Bang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter Riis', 'Initials': 'PR', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Helqvist', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Galatius', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frants', 'Initials': 'F', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Abildgaard', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Clemmensen', 'Affiliation': 'Department of General and Interventional Cardiology, University Heart Center Hamburg, University Clinic Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Saunamäki', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Holmvang', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'Department of Cardiology, Herlev-Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars V', 'Initials': 'LV', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Kofoed', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: kkofoed@dadlnet.dk.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.012']
3032,31899564,Counseling alone or in combination with nicotine replacement therapy for treatment of black non-daily smokers: a randomized trial.,"BACKGROUND AND AIMS


One-third of US tobacco users are non-daily smokers (NDS). Black NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with the participant's choice of nicotine replacement therapy.
DESIGN


Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2 : 1 intervention to control) SETTING: Academic medical and federally qualified health centers in three US cities.
PARTICIPANTS


Non-Hispanic black adult NDS receiving counseling with nicotine replacement therapy (C + NRT, n = 185) or counseling alone (C, n = 93).
INTERVENTIONS


Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy (NRT; C + NRT) or counseling alone (C). All participants received five sessions of counseling; those randomized to C + NRT received their choice of nicotine gum, patch and/or lozenge after a 9-day product trial period. The target quit day was set at 2 weeks post-baseline for both groups.
MEASUREMENTS


Primary outcome was biochemically verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino)-1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns.
FINDINGS


Abstinence was 11.4% in C + NRT and 8.6% in C [odds ratio (OR) = 1.4, 95% confidence interval (CI) = 0.6, 3.2, P = 0.48]. Both groups experienced significant reduction in NNAL (C + NRT: 53% reduction, C: 50% reduction, within-group P < 0.0001) but non-significant changes in cotinine (P = 0.69). C + NRT reported more days abstinent (P < 0.001) and fewer total cigarettes (P = 0.002) compared with C. There was no evidence of compensation with other tobacco products.
CONCLUSIONS


Among black non-daily smokers in the United States, there was no difference in abstinence between nicotine replacement therapy (NRT) and counseling alone. NRT led to greater increase in days abstinent and reduction in cigarettes, with no evidence of compensation from other sources of nicotine.",2020,C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C.,"[' Academic medical and federally qualified health centers in 3 US cities PARTICIPANTS: Non-Hispanic black adult NDS receiving counseling with', 'black non-daily smokers']","['nicotine replacement therapy (NRT', 'nicotine replacement therapy', 'NRT', 'Counseling alone or in combination with nicotine replacement therapy', 'nicotine replacement therapy (C+NRT, n=185) or counseling alone (C, n=93', 'telephone smoking cessation counseling in combination with nicotine replacement therapy [NRT; C+NRT', 'nicotine gum, patch, and/or lozenge', 'counseling alone [C', 'C+NRT']","['change in nicotine and carcinogen exposure [4-(methynitrosamino) -1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns', 'NNAL', 'total cigarettes', 'biochemically-verified 30-day abstinence']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C4521889', 'cui_str': 'Carcinogen (disposition)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0089147', 'cui_str': '1-Butanol'}, {'cui': 'C0543414', 'cui_str': 'Tobacco Chewing'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.160448,C+NRT reported more days abstinent (p<.001) and fewer total cigarettes (p=.002) compared with C.,"[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Nollen', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Jasjit S', 'Initials': 'JS', 'LastName': 'Ahluwalia', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14948']
3033,31841780,Sexual orientation correlates with baseline characteristics but shows no moderating effects of dissonance-based eating disorder prevention programs for women.,"This study provided the first test of whether sexual orientation (categorized as heterosexual vs. sexual minority) is associated with baseline eating disorder risk factors and symptoms, moderated the intervention effects of variants of the dissonance-based Body Project, or moderated the relation of baseline risk factors to future change in eating disorder symptoms. A total of 680 women with body image concerns were randomized to clinician-or peer-led Body Project groups, the eBody Project, or educational video control and completed assessment of eating disorder risk factors and symptoms at pretest, posttest, and at six-, 12-, 24-, and 36-month follow-up. Results indicated that sexual minority women had significantly higher negative affect and impaired psychosocial functioning at baseline, but did not differ on other eating disorder risk factors or symptoms. We found no evidence that sexual orientation moderates the effects of the Body Project on risk factor or symptom change over follow-up or the relation of baseline risk factors to future change in eating disorder symptoms. Overall, sexual minority and heterosexual women differ on two, less specific eating disorder-related risk factors at baseline, but did not differ in response to different versions of the Body Project or the relations of risk factors to future symptom change.",2020,We found no evidence that sexual orientation moderates the effects of the Body Project on risk factor or symptom change over follow-up or the relation of baseline risk factors to future change in eating disorder symptoms.,"['680 women with body image concerns', 'women']","['dissonance-based eating disorder prevention programs', 'sexual orientation (categorized as heterosexual vs. sexual minority', 'clinician-or peer-led Body Project groups, the eBody Project, or educational video control']","['specific eating disorder-related risk factors', 'psychosocial functioning', 'eating disorder risk factors or symptoms', 'risk factor or symptom change']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205949', 'cui_str': 'Sexual Orientation'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",680.0,0.0341479,We found no evidence that sexual orientation moderates the effects of the Body Project on risk factor or symptom change over follow-up or the relation of baseline risk factors to future change in eating disorder symptoms.,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Shaw', 'Affiliation': 'Oregon Research Institute, United States. Electronic address: hshaw@ori.org.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, United States.'}, {'ForeName': 'Christopher David', 'Initials': 'CD', 'LastName': 'Desjardins', 'Affiliation': 'Oregon Research Institute, United States.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Stanford University, United States.'}]",Body image,['10.1016/j.bodyim.2019.11.006']
3034,25609246,"A phase 3 randomized, double-blind, placebo-controlled trial of ganitumab or placebo in combination with gemcitabine as first-line therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial.","BACKGROUND


This double-blind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as first-line treatment of metastatic pancreatic cancer.
PATIENTS AND METHODS


Patients with previously untreated metastatic pancreatic adenocarcinoma were randomly assigned 2 : 2 : 1 to receive intravenous gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28-day cycle) plus placebo, ganitumab 12 mg/kg, or ganitumab 20 mg/kg (days 1 and 15 of each cycle). The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), safety, and efficacy by levels of circulating biomarkers.
RESULTS


Overall, 322 patients were randomly assigned to placebo, 318 to ganitumab 12 mg/kg, and 160 to ganitumab 20 mg/kg. The study was stopped based on results from a preplanned futility analysis; the final results are reported. Median OS was 7.2 months [95% confidence interval (CI), 6.3-8.2] in the placebo arm, 7.0 months (95% CI, 6.2-8.5) in the ganitumab 12-mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.82-1.21; P = 0.494], and 7.1 months (95% CI, 6.4-8.5) in the ganitumab 20-mg/kg arm (HR, 0.97; 95% CI, 0.76-1.23; P = 0.397). Median PFS was 3.7, 3.6 (HR, 1.00; 95% CI, 0.84-1.20; P = 0.520), and 3.7 months (HR, 0.97; 95% CI, 0.77-1.22; P = 0.403), respectively. No unexpected toxicity was observed with ganitumab plus gemcitabine. The circulating biomarkers assessed [insulin-like growth factor-1 (IGF-1), IGF-binding protein-2, and -3] were not associated with a treatment effect on OS or PFS by ganitumab.
CONCLUSION


Ganitumab combined with gemcitabine had manageable toxicity but did not improve OS, compared with gemcitabine alone in unselected patients with metastatic pancreatic cancer.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT01231347.",2015,"Median OS was 7.2 months [95% confidence interval (CI), 6.3-8.2] in the placebo arm, 7.0 months (95% CI, 6.2-8.5) in the ganitumab 12-mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.82-1.21; P = 0.494], and 7.1 months (95% CI, 6.4-8.5) in the ganitumab 20-mg/kg arm (HR, 0.97; 95% CI, 0.76-1.23; P = 0.397).","['322 patients', 'Patients with previously untreated metastatic pancreatic adenocarcinoma', 'metastatic pancreatic cancer', 'unselected patients with metastatic pancreatic cancer', 'metastatic adenocarcinoma of the pancreas']","['ganitumab combined with gemcitabine', 'gemcitabine', 'placebo', 'ganitumab or placebo', 'placebo, ganitumab 12 mg/kg, or ganitumab', 'intravenous gemcitabine']","['toxicity', 'circulating biomarkers assessed [insulin-like growth factor-1 (IGF-1), IGF-binding protein-2, and -3', 'efficacy and safety', 'overall survival (OS', 'Median OS', 'progression-free survival (PFS), safety, and efficacy by levels of circulating biomarkers', 'Median PFS', 'manageable toxicity']","[{'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}]","[{'cui': 'C2980089'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123257', 'cui_str': 'Insulin-Like Growth Factor Binding Protein 2'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",322.0,0.740195,"Median OS was 7.2 months [95% confidence interval (CI), 6.3-8.2] in the placebo arm, 7.0 months (95% CI, 6.2-8.5) in the ganitumab 12-mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.82-1.21; P = 0.494], and 7.1 months (95% CI, 6.4-8.5) in the ganitumab 20-mg/kg arm (HR, 0.97; 95% CI, 0.76-1.23; P = 0.397).","[{'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Department of Medical Oncology/Solid Tumor Oncology, Dana-Farber Cancer Institute, Boston, USA. Electronic address: charles_fuchs@dfci.harvard.edu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Azevedo', 'Affiliation': 'Oncology Service, Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Lipton', 'Affiliation': 'Medical Oncology, Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Department of Hematology, Oncology, and Tumor Immunology, Charité University, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Szczylik', 'Affiliation': 'Department of Oncology, Military Institute of Health Services, Warsaw, Poland.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Moore', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, Antwerp University Hospital, Edegum, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bodoky', 'Affiliation': 'Department of Oncology, St László Hospital, Budapest, Hungary.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacký University Medical School and Teaching Hospital, Olomouc.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Nemecek', 'Affiliation': 'Department of Oncology, Masaryk University Medical School and Masaryk Memorial Cancer Institute, Brno, Czech Republic.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ohkawa', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Świeboda-Sadlej', 'Affiliation': 'Department of Haematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Loberg', 'Affiliation': 'Medical Sciences, Amgen Inc., Thousand Oaks, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Haddad', 'Affiliation': 'Global Biostatistical Science, Amgen Ltd, Cambridge, UK.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Gansert', 'Affiliation': 'Global Development, Thousand Oaks.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Bach', 'Affiliation': 'Development Oncology Therapeutics, Amgen Inc., Thousand Oaks, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Carrato', 'Affiliation': 'Medical Oncology Department, University Hospital Ramon y Cajal, Madrid, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv027']
3035,32023537,Exploration of Habitual Walking Behavior and Home-Based Muscle Power Training in Individuals With Total Knee Arthroplasty.,"BACKGROUND


The purpose of this study was to investigate the effects of a home-based muscle power training program on muscle strength and power, functional performance, and physical activity behavior in individuals at least 6 months posttotal knee arthroplasty.
METHODS


Twelve men and women, mean age 63.9 (6.8) and 6 months to 2 years posttotal knee arthroplasty unilateral or bilateral), completed this study. Participants were randomly assigned to the home-based power training intervention or step-monitoring comparison group. Quadriceps muscle strength and power, 6-minute walk test, functional leg power, and habitual walking behavior (average daily steps, minutes per week of moderate to vigorous physical activity) were assessed before and after intervention and then compared between and within groups.
RESULTS


The authors found no significant differences between the groups on amount of change in any of the outcomes, but mixed results on differences within each of the groups on the outcome measures.
CONCLUSION


There were no differences between the groups for amount of change on the outcome measures the authors selected. Although within group differences varied slightly for each group, it was not enough to justify the more expensive home-based power training over the simpler step-monitoring intervention.",2020,There were no differences between the groups for amount of change on the outcome measures the authors selected.,"['Twelve men and women, mean age 63.9 (6.8) and 6 months to 2 years posttotal knee arthroplasty unilateral or bilateral', 'Individuals With Total Knee Arthroplasty', 'individuals at least 6 months posttotal knee arthroplasty']","['Habitual Walking Behavior and Home-Based Muscle Power Training', 'home-based muscle power training program', 'home-based power training intervention or step-monitoring comparison group']","['Quadriceps muscle strength and power, 6-minute walk test, functional leg power, and habitual walking behavior (average daily steps, minutes per week of moderate to vigorous physical activity', 'muscle strength and power, functional performance, and physical activity behavior']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3853978'}]",12.0,0.0165304,There were no differences between the groups for amount of change on the outcome measures the authors selected.,"[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Trudelle-Jackson', 'Affiliation': ''}, {'ForeName': 'Emerenciana', 'Initials': 'E', 'LastName': 'Hines', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Medley', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0233']
3036,32025883,Influence of ozone application in the stepwise excavation of primary molars: a randomized clinical trial.,"OBJECTIVES


The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to investigate the clinical and microbiological effects of the ozone application in stepwise excavation of primary molars.
MATERIALS AND METHODS


This study was conducted in in vivo conditions with 105 lower primary molars that had deep caries lesions. The teeth were randomly divided into three groups: (I) control group, conventional stepwise excavation with no disinfectants; (II) CHX (positive control) group, 2% chlorhexidine digluconate; and (III) experimental group, ozone application. Dentine samples were collected at 4 different time points (T0, at the first appointment, after partial removal of carious dentin; T1, at the first appointment, after applying disinfection procedure; T2, at the second appointment - at the end of the 4-month period - immediately after the removal of the temporary restoration; T3, at the second appointment, after the final excavation) for the microbiological analysis of mutans streptococci and lactobacilli and the total number of colony-forming units. Clinical changes including dentin color, humidity, and consistency were recorded. Data were analyzed using the Mann-Whitney U test, Friedman test, and chi-squared test (p = 0.05).
RESULTS


The dentin became harder and drier after 4 months in all the groups. There was a gradual reduction in the total number of microorganisms in all the three groups. Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
CONCLUSION


Stepwise excavation of primary teeth provided successful outcomes in all the groups. Moreover, CHX, due to its practicality and cost-effectiveness, can be effectively used with one- or two-step indirect pulp therapies.
CLINICAL RELEVANCE


Usage of cavity disinfectants in the stepwise excavation procedure contributes to the reduction of bacterial population in the cavity, which may allow the avoidance of the second step of the indirect pulp therapy for primary teeth.",2020,"Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
","['105 lower primary molars that had deep caries lesions', 'primary molars']","['ozone application', 'CHX', 'control group, conventional stepwise excavation with no disinfectants; (II) CHX (positive control) group, 2% chlorhexidine digluconate; and (III) experimental group, ozone application']","['Bacterial reduction', 'total number of microorganisms', 'dentin color, humidity, and consistency']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333523', 'cui_str': 'Deep caries (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",105.0,0.0300688,"Bacterial reduction was greater in the CHX group compared to the ozone group (p = 0.002) and was greater in the ozone group compared to the control group (p = 0.015) after 4 months (control, 78%; CHX, 93%; ozone, 82%).
","[{'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Mese', 'Affiliation': 'Department of Pedodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Yesim Tuyji', 'Initials': 'YT', 'LastName': 'Tok', 'Affiliation': 'Department of Medical Microbiology, Atatürk Training and Research Hospital, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Kaya', 'Affiliation': 'Department of Medical Microbiology, Atatürk Training and Research Hospital, Izmir Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Akcay', 'Affiliation': 'Department of Pedodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey. merve.akcay@ikc.edu.tr.'}]",Clinical oral investigations,['10.1007/s00784-020-03223-6']
3037,32027157,Trajectories of change in well-being during cognitive behavioral therapies for anxiety disorders: Quantifying the impact and covariation with improvements in anxiety.,"Cognitive behavioral therapy (CBT) has been found to be very effective in reducing many forms of mental illness, but much less is known about whether CBT also promotes mental health or well-being. The goals of the present study were to (a) quantify the magnitude and timing of changes in overall well-being and specific facets of well-being during different CBTs for anxiety disorders, (b) determine whether these effects vary across transdiagnostic and disorder-specific CBT, and (c) examine how changes in well-being during treatment relate to changes in anxiety. A total of 223 adults (55.6% female, Mage = 31.1 years) were randomized to 1 of 5 CBT protocols for anxiety disorders at an outpatient clinic. Analyses included standardized mean gain effect sizes (ESsg) and latent growth curve modeling. Moderate-to-large increases in overall well-being and the 3 components of subjective, psychological, and social well-being were observed, mainly during the second half of CBT, and these increases were maintained at a 6-month follow-up. The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition. Parallel process latent growth curve models indicated that trajectories of change in well-being across treatment were strongly correlated with trajectories of change in clinician-rated and self-reported anxiety. Together, these findings suggest that different CBT protocols for anxiety consistently produce robust and lasting changes in well-being, and these changes are strongly linked to changes in anxiety during treatment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition.,"['anxiety disorders', '223 adults (55.6% female, Mage = 31.1 years']","['cognitive behavioral therapies', 'CBT protocols', 'Cognitive behavioral therapy (CBT']","['standardized mean gain effect sizes (ESsg) and latent growth curve modeling', 'anxiety']","[{'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",223.0,0.0152392,The magnitude of effects was comparable for transdiagnostic and disorder-specific CBT protocols and greater than in the waitlist condition.,"[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Gallagher', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Long', 'Affiliation': 'Department of Psychology, Texas Institute for Measurement, Evaluation, and Statistics, University of Houston.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Farchione', 'Affiliation': 'Department of Psychology, Boston University.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Barlow', 'Affiliation': 'Department of Psychology, Boston University.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000283']
3038,31351189,"Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis.","BACKGROUND


Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL-4 and IL-13 signaling, key drivers of type 2 inflammation. In the phase 3 study (NCT02414854), add-on dupilumab 200 mg/300 mg every 2 weeks, versus placebo, significantly reduced severe asthma exacerbations and improved pre-bronchodilator forced expiratory volume in 1 second (FEV 1 ) and quality-of-life measures in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in those with a high baseline type 2 phenotype.
OBJECTIVE


To assess the efficacy and safety of dupilumab in patients with uncontrolled, moderate-to-severe asthma with or without self-reported comorbid chronic rhinosinusitis (CRS or non-CRS).
METHODS


Comorbid CRS was self-reported by patients using an e-diary. Annualized severe exacerbation rates, changes from baseline in pre- and post-bronchodilator FEV 1 , patient-reported outcomes, type 2 biomarkers, and safety were assessed.
RESULTS


CRS was self-reported by 382 of 1902 (20.1%) patients. Dupilumab 200 mg/300 mg reduced annualized severe exacerbation rates by 63%/61%, respectively, in patients with CRS, and by 42%/40% in patients without CRS (all P < .001 vs placebo). Dupilumab also improved lung function and patient-reported asthma control and quality of life, and suppressed type 2 biomarkers versus placebo in both subgroups. Clinical responses were rapid, with near-maximal responses observed at the earliest measured time points and sustained at week 52. Improvements observed in the CRS subgroup were similar to or numerically greater than those in the non-CRS subgroup.
CONCLUSION


Dupilumab showed efficacy and was generally well tolerated in patients with uncontrolled, moderate-to-severe asthma with or without CRS.",2020,"Dupilumab also improved lung function and patient-reported asthma control and quality of life, and suppressed type 2 biomarkers versus placebo in both subgroups.","['uncontrolled, moderate-to-severe asthma patients with or without self-reported comorbid chronic rhinosinusitis (CRS or non-CRS', 'patients with uncontrolled, moderate-to-severe asthma with or without CRS', 'Uncontrolled, Moderate-to-Severe Asthma With Self-reported Chronic Rhinosinusitis']","['placebo', 'dupilumab']","['Annualized severe exacerbation rates', 'severe asthma exacerbations and improved pre-bronchodilator forced expiratory volume in 1 second (FEV 1 ) and quality-of-life measures', 'efficacy and safety', 'annualized severe exacerbation rates', 'lung function and patient-reported asthma control and quality of life']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.148526,"Dupilumab also improved lung function and patient-reported asthma control and quality of life, and suppressed type 2 biomarkers versus placebo in both subgroups.","[{'ForeName': 'Jorge F', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Fundación CIDEA, Buenos Aires, Argentina. Electronic address: jorge.maspero@fundacioncidea.org.ar.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Katelaris', 'Affiliation': 'Campbelltown Hospital, Campbelltown, NSW, Australia; Western Sydney University, Sydney, NSW, Australia.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Busse', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, Wis.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Washington University School of Medicine, Saint Louis, Mo.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, Calif.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, Calif.'}, {'ForeName': 'Anju T', 'Initials': 'AT', 'LastName': 'Peters', 'Affiliation': 'Division of Allergy-Immunology and the Sinus and Allergy Center, Feinberg School of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Ford', 'Affiliation': 'Asthma & Allergy Center, Bellevue, Neb.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Sher', 'Affiliation': 'Peninsula Research Associates, Rolling Hills Estates, Calif.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany; Christian-Albrechts-University of Kiel, Member of the German Center for Lung Research (DZL), Kiel, Germany.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi Genzyme, Cambridge, Mass.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jagerschmidt', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Leda P', 'Initials': 'LP', 'LastName': 'Mannent', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.07.016']
3039,25632066,A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer.,"BACKGROUND


Previous clinical trials have not proved that adding epidermal growth factor receptor inhibitors to chemotherapy confers a survival benefit for patients with advanced biliary tract cancer (ABTC). Whether the KRAS mutation status of tumor cells confounded the results of past studies is unknown.
PATIENTS AND METHODS


ABTC patients stratified by KRAS status, Eastern Cooperative Oncology Group performance status, and primary tumor location were randomized 1 : 1 to receive GEMOX (800 mg/m(2) gemcitabine and 85 mg/m(2) oxaliplatin) or C-GEMOX (500 mg/m(2) cetuximab plus GEMOX) every 2 weeks. The primary end point was objective response rate (ORR).
RESULTS


The study enrolled 122 patients between December 2010 and May 2012 (62 treated with C-GEMOX and 60 with GEMOX). Compared with GEMOX alone, C-GEMOX was associated with trend to better ORR (27% versus 15%; P = 0.12) and progression-free survival (PFS, 6.7 versus 4.1 months; P = 0.05), but not overall survival (OS, 10.6 versus 9.8 months; P = 0.91). KRAS mutations, which were detected in 36% of tumor samples, did not affect the trends of difference in ORR and PFS between C-GEMOX and GEMOX. The two treatment arms had similar adverse events, except that more patients had skin rashes, allergic reactions, and neutropenia in the C-GEMOX arm. Of patients with C-GEMOX, the presence of a grade 2 or 3 skin rash was associated with significantly better ORR, PFS, and OS.
CONCLUSIONS


Addition of cetuximab did not significantly improve the ORR of GEMOX chemotherapy in ABTC, although a trend of PFS improvement was observed. The trend of improvement did not correlate with KRAS mutation status.
CLINICAL TRIALS NUMBER


This study is registered at ClinicalTrials.gov (NCT01267344). All patients gave written informed consent.",2015,"The two treatment arms had similar adverse events, except that more patients had skin rashes, allergic reactions, and neutropenia in the C-GEMOX arm.","['advanced biliary tract cancer', 'patients with advanced biliary tract cancer (ABTC', 'ABTC patients stratified by KRAS status, Eastern Cooperative Oncology Group performance status, and primary tumor location', '122 patients between December 2010 and May 2012 (62 treated with C-GEMOX and 60 with GEMOX']","['GEMOX', 'cetuximab', 'GEMOX (800 mg/m(2) gemcitabine and 85 mg/m(2) oxaliplatin) or C-GEMOX (500 mg/m(2) cetuximab plus GEMOX', 'gemcitabine and oxaliplatin alone or in combination with cetuximab']","['ORR and PFS', 'ORR of GEMOX chemotherapy', 'objective response rate (ORR', 'skin rashes, allergic reactions, and neutropenia', 'ORR, PFS, and OS', 'overall survival', 'PFS improvement', 'progression-free survival', 'ORR', 'adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",122.0,0.0911302,"The two treatment arms had similar adverse events, except that more patients had skin rashes, allergic reactions, and neutropenia in the C-GEMOX arm.","[{'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'on behalf of the Taiwan Cooperative Oncology Group Division of Hematology and Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital and Chang Gung University, Taoyuan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hsu', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Chiang', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Tainan; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Tsai', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Tainan Municipal Hospital, Tainan.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Tsou', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, Miaoli.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Huang', 'Affiliation': 'Institute of Molecular and Genomic Medicine, National Health Research Institutes, Miaoli.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Bai', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung.'}, {'ForeName': 'I C', 'Initials': 'IC', 'LastName': 'Chang', 'Affiliation': 'Institute of Molecular and Genomic Medicine, National Health Research Institutes, Miaoli.'}, {'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Shiah', 'Affiliation': 'Taipei Cancer Center, Taipei Medical University Hospital, Taipei.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ho', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Tri-Service General Hospital, Taipei.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Yen', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Chiu', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, Taichung.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Rau', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Yu', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Hsieh', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, MacKay Memorial Hospital, Taipei.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Tainan; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan.'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Shan', 'Affiliation': 'Department of Surgery, National Cheng Kung University Hospital, Tainan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'L T', 'Initials': 'LT', 'LastName': 'Chen', 'Affiliation': 'National Institute of Cancer Research, National Health Research Institutes, Tainan; Division of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan; Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung. Electronic address: leochen@nhri.org.tw.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv035']
3040,25669832,Randomized phase II study of concurrent versus sequential alternating gefitinib and chemotherapy in previously untreated non-small cell lung cancer with sensitive EGFR mutations: NEJ005/TCOG0902.,"BACKGROUND


The first-line combination of an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and platinum-based doublet chemotherapy has not been sufficiently evaluated for patients with EGFR-mutant non-small cell lung cancer (NSCLC). This randomized phase II study was designed to select a combination regimen for phase III evaluation.
PATIENTS AND METHODS


Chemotherapy-naïve patients with advanced non-squamous, EGFR-mutant NSCLC were randomly assigned to receive either a concurrent or a sequential alternating regimen with gefitinib (250 mg) and carboplatin/pemetrexed [area under the curve (AUC) = 6 and 500 mg/m(2); 3-weekly]. The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), response, and safety.
RESULTS


All 80 patients enrolled were eligible and assessable for efficacy (41 and 39 patients in the concurrent and sequential alternating regimen groups, respectively). Median PFS was 18.3 months for the concurrent regimen and 15.3 months for the sequential alternating regimen [hazard ratio (HR) 0.71 (0.42-1.20), P = 0.20]. Although OS data are immature (16 and 24 death events), median survival times were 41.9 and 30.7 months in the concurrent and sequential alternating regimen groups, respectively [HR 0.51 (0.26-0.99); P = 0.042]. Response rates were similar in both groups (87.8% and 84.6%). Hematological and non-hematological adverse events were common and reversible; interstitial lung disease was neither frequent nor fatal (two cases in each group; 5% of all patients).
CONCLUSION


This is the first randomized study to investigate the efficacy of combinational EGFR-TKI and chemotherapy in the EGFR-mutated setting. Both regimens had promising efficacy with predictable toxicities, although concurrent regimens might provide better OS. The concurrent regimen was chosen to compare with gefitinib monotherapy in our ongoing phase III study.
CLINICAL TRIALS REGISTRATION


University Hospital Medical Information Network (UMIN) Clinical Trial Registry (UMIN C000002789).",2015,"All 80 patients enrolled were eligible and assessable for efficacy (41 and 39 patients in the concurrent and sequential alternating regimen groups, respectively).","['Chemotherapy-naïve patients with advanced non-squamous, EGFR-mutant NSCLC', 'previously untreated non-small cell lung cancer with sensitive EGFR mutations', 'patients with EGFR-mutant non-small cell lung cancer (NSCLC', 'All 80 patients enrolled were eligible and assessable for efficacy (41 and 39 patients in the concurrent and sequential alternating regimen groups, respectively']","['epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and platinum-based doublet chemotherapy', 'sequential alternating gefitinib and chemotherapy', 'gefitinib (250 mg) and carboplatin/pemetrexed [area under the curve (AUC) ', 'combinational EGFR-TKI and chemotherapy', 'gefitinib monotherapy']","['overall survival (OS), response, and safety', 'Median PFS', 'median survival times', 'Response rates', 'Hematological and non-hematological adverse events', 'progression-free survival (PFS']","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C0033681', 'cui_str': 'Tyrosylprotein Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",80.0,0.0289866,"All 80 patients enrolled were eligible and assessable for efficacy (41 and 39 patients in the concurrent and sequential alternating regimen groups, respectively).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sugawara', 'Affiliation': 'Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Oizumi', 'Affiliation': 'First Department of Medicine, Hokkaido University School of Medicine, Sapporo. Electronic address: soizumi@med.hokudai.ac.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Minato', 'Affiliation': 'Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harada', 'Affiliation': 'Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Respiratory Medicine, Tohoku University Hospital, Sendai.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Fujita', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Department of Respiratory Medicine, Miyagi Cancer Center, Natori.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yoshizawa', 'Affiliation': 'Bioscience Medical Research Center, Niigata University Medical and Dental Hospital, Niigata.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Respiratory Medicine, Niigata City General Hospital, Niigata.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Nippon Medical School, Graduate School of Medicine, Tokyo.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nishitsuji', 'Affiliation': 'Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Isobe', 'Affiliation': 'Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Respiratory Medicine, Saitama Medical University, Saitama.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kurihara', 'Affiliation': 'Tokyo Cooperative Oncology Group, Tokyo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Japan Anti-Tuberculosis Association, Tokyo, Japan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv063']
3041,25722380,Effect of BRCA1 and XPG mutations on treatment response to trabectedin and pegylated liposomal doxorubicin in patients with advanced ovarian cancer: exploratory analysis of the phase 3 OVA-301 study.,"BACKGROUND


We investigated the association of BRCA1 and XPG mutations with response rate (RR), progression-free survival (PFS) and overall survival (OS) in a subset of patients from a phase 3 clinical trial comparing the efficacy and safety of trabectedin + pegylated liposomal doxorubicin (PLD) versus PLD alone in patients with recurrent ovarian cancer.
PATIENTS AND METHODS


A candidate array was designed based on the Breast Cancer Information Core database for BRCA mutation analyses. An exploratory analysis of BRCA1/XPG mutation status was conducted using a two-sided log-rank test and 0.05 significance in germline DNA samples from 264 women with failed first-line platinum-based chemotherapy, randomized (1 : 1) to trabectedin + PLD or PLD alone.
RESULTS


Overall, 41 (16%) of the 264 women had BRCA1(mut) (trabectedin + PLD: n = 24/135, 18%; PLD: n = 17/129; 13%) and 17 (6%) had XPG(mut) (trabectedin + PLD: n = 8/135, 6%; PLD: n = 9/129, 7%). A higher RR was observed in BRCA1(mut) patients (20/41; 49%) versus BRCA1(wt) patients (62/223; 28%). Within the BRCA1(mut) group, trabectedin + PLD-treated patients had longer PFS and longer OS than PLD-treated patients (median PFS 13.5 versus 5.5 months, P = 0.0002; median OS 23.8 versus 12.5 months, P = 0.0086), whereas in BRCA1(wt) patients, OS was not significantly different (median OS: 19.1 versus 19.3 months; P = 0.9377). There were no differences in OS or PFS of patients with XPG(mut) between the two treatment arms. However, trabectedin + PLD-treated patients with XPG(mut) had a trend toward shorter PFS (median PFS: 1.9 versus 7.5 months; P = 0.1666) and OS (median OS: 14.5 versus 20.7 months; P = 0.1774) than those with XPG(wt).
CONCLUSIONS


In this exploratory analysis, patients with recurrent ovarian cancer carrying the BRCA1(mut) had improved outcomes with trabectedin + PLD treatment compared with PLD alone. Prospective evaluation of BRCA status is likely an important evaluation for DNA-damaging agents and may significantly impact interpretation of clinical studies. XPG may be a biomarker of poor outcome in these patients.",2015,"patients, OS was not significantly different (median OS: 19.1 versus 19.3 months; P = 0.9377).","['patients with recurrent ovarian cancer', '264 women had BRCA1(mut', '264 women with failed first-line platinum-based chemotherapy, randomized (1 : 1) to', 'patients with recurrent ovarian cancer carrying the BRCA1(mut', 'patients with advanced ovarian cancer']","['trabectedin and pegylated liposomal doxorubicin', 'BRCA1 and XPG mutations', 'XPG', 'trabectedin + PLD or PLD alone', 'BRCA1(wt', 'trabectedin + pegylated liposomal doxorubicin (PLD) versus PLD alone', 'trabectedin + PLD']","['shorter PFS', 'OS or PFS', 'longer PFS and longer OS', 'XPG(mut', 'response rate (RR), progression-free survival (PFS) and overall survival (OS', 'BRCA1(wt']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",264.0,0.115545,"patients, OS was not significantly different (median OS: 19.1 versus 19.3 months; P = 0.9377).","[{'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': ""Division of Gynecologic Oncology, University of Arizona Cancer Center, Creighton University School of Medicine, at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, USA. Electronic address: bradley.monk@chw.edu.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ghatage', 'Affiliation': 'Department of Gynecologic Oncology, University of Calgary, Alberta, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Henitz', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Knoblauch', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Matos-Pita', 'Affiliation': 'Department of Clinical R&D, PharmaMar SA, Madrid.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Department of Clinical R&D, PharmaMar SA, Madrid.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Cheng', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Favis', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ricci', 'Affiliation': 'Department of Gynecologic Oncology, Janssen Research & Development LLC, Raritan, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Department of Medical Oncology, Fundación Instituto Valenciano de Oncología, València, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv071']
3042,25900678,"FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial.",,2015,,['patients with resectable metastatic colorectal cancer (MIROX'],"['perioperative or postoperative chemotherapy', 'FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C1273551', 'cui_str': 'Postoperative chemotherapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]",[],,0.0271037,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hebbar', 'Affiliation': 'Department of Medical Oncology, University Hospital, Lille.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chibaudel', 'Affiliation': 'Department of Medical Oncology, Hospital Saint-Antoine, Paris.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, Hospital Saint-Antoine, Paris.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Department of Radiotherapy, Institute Sainte-Catherine, Avignon.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': 'Department of Medical Oncology and Radiotherapy, Hospital Saint-André, Bordeaux.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Oncology, Institute Mutualiste Montsouris, Paris.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Dutel', 'Affiliation': 'Department of Medical Oncology, Radiotherapy Service, Hospital Centre Beauvais, Beauvais.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ychou', 'Affiliation': ""Regional Centre against Cancer, Val d'Aurelle-Paul Lamarque, Montpellier.""}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Legoux', 'Affiliation': 'Department of Hepatology and Gastroenterology, Hospital de Haut-Lévêque, Pessac.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mabro', 'Affiliation': 'Department of Medical Oncology, Hospital Foch, Suresnes.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Department of Gastroenterology, Hospital La Roche-sur-Yon, La Roche-sur-Yon.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Auby', 'Affiliation': 'Department of Medicine, Hospital Libourne, Libourne.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brusquant', 'Affiliation': 'GERCOR, Paris.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': 'Department of Medical Oncology, Hospital Tenon, Paris.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Truant', 'Affiliation': 'Department of Digestive Surgery and Transplantation, University Hospital, Lille.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hadengue', 'Affiliation': 'GERCOR, Paris.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'Methodology and Quality of Life in Oncology Department EA 3181, Hospital Besançon, Besançon.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gayet', 'Affiliation': 'Department of Surgery, Institute Mutualiste Montsouris, Paris.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Paye', 'Affiliation': 'Department of Digestive Surgery, Hospital Saint-Antoine, Paris, France.'}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Pruvot', 'Affiliation': 'Department of Digestive Surgery and Transplantation, University Hospital, Lille.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bonnetain', 'Affiliation': 'Methodology and Quality of Life in Oncology Department EA 3181, Hospital Besançon, Besançon.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'de Gramont', 'Affiliation': 'Department of Medical Oncology, Hospital Saint-Antoine, Paris.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv141']
3043,25722381,A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC)†.,"BACKGROUND


KRAS mutations are detected in 25% of non-small-cell lung cancer (NSCLC) and no targeted therapies are approved for this subset population. Trametinib, a selective allosteric inhibitor of MEK1/MEK2, demonstrated preclinical and clinical activity in KRAS-mutant NSCLC. We report a phase II trial comparing trametinib with docetaxel in patients with advanced KRAS-mutant NSCLC.
PATIENTS AND METHODS


Eligible patients with histologically confirmed KRAS-mutant NSCLC previously treated with one prior platinum-based chemotherapy were randomly assigned in a ratio of 2 : 1 to trametinib (2 mg orally once daily) or docetaxel (75 mg/m(2) i.v. every 3 weeks). Crossover to the other arm after disease progression was allowed. Primary end point was progression-free survival (PFS). The study was prematurely terminated after the interim analysis of 92 PFS events, which showed the comparison of trametinib versus docetaxel for PFS crossed the futility boundary.
RESULTS


One hundred and twenty-nine patients with KRAS-mutant NSCLC were randomized; of which, 86 patients received trametinib and 43 received docetaxel. Median PFS was 12 weeks in the trametinib arm and 11 weeks in the docetaxel arm (hazard ratio [HR] 1.14; 95% CI 0.75-1.75; P = 0.5197). Median overall survival, while the data are immature, was 8 months in the trametinib arm and was not reached in the docetaxel arm (HR 0.97; 95% CI 0.52-1.83; P = 0.934). There were 10 (12%) partial responses (PRs) in the trametinib arm and 5 (12%) PRs in the docetaxel arm (P = 1.0000). The most frequent adverse events (AEs) in ≥20% of trametinib patients were rash, diarrhea, nausea, vomiting, and fatigue. The most frequent grade 3 treatment-related AEs in the trametinib arm were hypertension, rash, diarrhea, and asthenia.
CONCLUSION


Trametinib showed similar PFS and a response rate as docetaxel in patients with previously treated KRAS-mutant-positive NSCLC.
CLINICALTRIALSGOV REGISTRATION NUMBER


NCT01362296.",2015,"The most frequent adverse events (AEs) in ≥20% of trametinib patients were rash, diarrhea, nausea, vomiting, and fatigue.","['patients with previously treated KRAS-mutant-positive NSCLC', 'Eligible patients with histologically confirmed KRAS-mutant NSCLC previously treated with one prior platinum-based chemotherapy', 'One hundred and twenty-nine patients with KRAS-mutant NSCLC were randomized; of which, 86 patients received', 'patients with advanced KRAS-mutant NSCLC', 'KRAS-mutant advanced non-small-cell lung cancer (NSCLC)†']","['trametinib (2 mg orally once daily) or docetaxel', 'docetaxel', 'trametinib and 43 received docetaxel', 'MEK1/MEK2 inhibitor trametinib (GSK1120212']","['partial responses (PRs', 'response rate', 'Median overall survival', 'Median PFS', 'rash, diarrhea, nausea, vomiting, and fatigue', 'hypertension, rash, diarrhea, and asthenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C2697961', 'cui_str': 'trametinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2703095', 'cui_str': 'GSK 1120212'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",129.0,0.150481,"The most frequent adverse events (AEs) in ≥20% of trametinib patients were rash, diarrhea, nausea, vomiting, and fatigue.","[{'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': 'MD Anderson Cancer Center, The University of Texas, Houston, USA. Electronic address: gblumens@mdanderson.org.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Department of Pulmonary Diseases, Vrije Universiteit VU Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Planchard', 'Affiliation': 'Medical Oncology Department, Gustave Roussy (GR), Villejuif, France.'}, {'ForeName': 'D-W', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'Department of Respiratory Medicine, Hôpital Tenon, Assistance Publique - Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'De Pas', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dunphy', 'Affiliation': 'Duke University Medical Center, Durham, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Udud', 'Affiliation': 'Korányi National Institute of Tuberculosis and Pulmonology, Budapest, Hungary.'}, {'ForeName': 'M-J', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'N H', 'Initials': 'NH', 'LastName': 'Hanna', 'Affiliation': 'IU Melvin and Bren Simon Cancer Center, Indianapolis, USA.'}, {'ForeName': 'J-H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Yonsei Cancer Center, Division of Medical Oncology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Hopital Larrey CHU Toulouse, Toulouse, France.'}, {'ForeName': 'S-W', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rappold', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Redhu', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Puski', 'Affiliation': 'GlaxoSmithKline Kft., Budapest, Hungary.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Wu', 'Affiliation': 'GlaxoSmithKline, Collegeville, USA.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Jänne', 'Affiliation': 'Lowe Center for Thoracic Oncology, Belfer Institute for Applied Cancer Science Dana-Farber Cancer Institute, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv072']
3044,25688059,Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trial†.,"BACKGROUND


This randomized phase II-III trial sought to evaluate the efficacy and safety of adding bevacizumab (Bev) following induction chemotherapy (CT) in extensive small-cell lung cancer (SCLC).
PATIENTS AND METHODS


Enrolled SCLC patients received two induction cycles of CT. Responders were randomly assigned 1:1 to receive four additional cycles of CT alone or CT plus Bev (7.5 mg/kg), followed by single-agent Bev until progression or unacceptable toxicity. The primary end point was the percentage of patients for whom disease remained controlled (still in response) at the fourth cycle.
RESULTS


In total, 147 patients were enrolled. Partial response was observed in 103 patients, 74 of whom were eligible for Bev and randomly assigned to the CT alone group (n = 37) or the CT plus Bev group (n = 37). Response assessment at the end of the fourth cycle showed that disease control did not differ between the two groups (89.2% versus 91.9% of patients remaining responders in CT alone versus CT plus Bev, respectively; Fisher's exact test: P = 1.00). Progression-free survival (PFS) since randomization did not significantly differ, with a median PFS of 5.5 months [95% confidence interval (CI) 4.9% to 6.0%] versus 5.3 months (95% CI 4.8% to 5.8%) in the CT alone and CT plus Bev groups, respectively [hazard ratio (HR) for CT alone: 1.1; 95% CI 0.7% to 1.7%; unadjusted P = 0.82]. Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group. Serum vascular endothelial growth factor (VEGF) and soluble VEGF receptor titrations failed to identify predictive biomarkers.
CONCLUSION


Administering 7.5 mg/kg Bev after induction did not improve outcome in extensive SCLC patients.",2015,"Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group.","['147 patients were enrolled', 'extensive SCLC patients', '103 patients, 74 of whom were eligible for Bev', 'extensive small-cell lung cancer (SCLC', 'Enrolled SCLC patients', 'previously untreated extensive small-cell lung cancer']","['bevacizumab (Bev) following induction chemotherapy (CT', 'IFCT-0802 trial†', 'CT', 'bevacizumab', 'chemotherapy', 'CT alone or CT plus Bev']","['Serum vascular endothelial growth factor (VEGF', 'efficacy and safety', 'Grade ≥2 hypertension and grade ≥3 thrombotic events', 'Partial response', 'Progression-free survival (PFS', 'disease control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",147.0,0.144501,"Grade ≥2 hypertension and grade ≥3 thrombotic events were observed in 40% and 11% of patients, respectively, in the CT plus Bev group.","[{'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Pujol', 'Affiliation': 'Pneumology Department, University Hospital, Montpellier. Electronic address: jl-pujol@chu-montpellier.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lavole', 'Affiliation': 'Pneumology Department, AP-HP Hospital Tenon, Paris.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quoix', 'Affiliation': 'Pneumology Department, University Hospital, Strasbourg.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Respiratory Diseases Department, Le Mans Hospital, Le Mans.'}, {'ForeName': 'P-J', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Pneumology Department, Pierre-Bénite Hospital, Lyon.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Oncology Department, Hopital Nord, Aix-Marseille University.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Le Caer', 'Affiliation': 'Pneumology Department, Draguignan Hospital, Draguignan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Pneumology Department, University Hospital, Grenoble.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fournel', 'Affiliation': 'Oncology Department, Loire Cancer Institute, St-Priest-en-Jarez.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Oster', 'Affiliation': 'Pneumology Department, Colmar Hospital, Colmar.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Chatellain', 'Affiliation': 'Pneumology Department, Alpes-Léman Hospital, Ambilly.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Barre', 'Affiliation': 'Pneumology Department, Jean Rougier Hospital, Cahors.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jeannin', 'Affiliation': 'Pneumology Department, Gabriel Montpied University Hospital, Clermont-Ferrand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Mourlanette', 'Affiliation': 'Pneumology Department, Private Hospital, Cornebarrieu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Derollez', 'Affiliation': 'Pneumology Department, Private Hospital, Maubeuge.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Herman', 'Affiliation': 'Pneumology Department, Nevers Hospital, Nevers.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Renault', 'Affiliation': 'Pneumology Department, Pau Hospital, Pau.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dayen', 'Affiliation': 'Pneumology Department, Saint-Quentin Hospital, Saint-Quentin.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Lamy', 'Affiliation': 'Department of Biopathology and Oncogenetics, Regional Cancer Institute, Montpellier.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'French Cooperative Thoracic Intergroup (IFCT), Paris.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'French Cooperative Thoracic Intergroup (IFCT), Paris.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'Pneumology Department, University Hospital, Caen, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdv065']
3045,31921328,"Effectiveness of a new approach for exclusive breastfeeding counselling on breastfeeding prevalence, infant growth velocity and postpartum weight loss in overweight or obese women: protocol for a randomized controlled trial.","Background


Maternal overweight, infant feeding and early growth velocity are risk factors for obesity later in life. The first one thousand days are a window of opportunity to program health and disease. Exclusive breastfeeding may protect against obesity; however, it is not consistently practiced. Obesity rates have been increasing worldwide. Overweight or obese women have lower rates of breastfeeding and face mechanical, psychological and biological difficulties. Breastfeeding counselling is a successful strategy to support breastfeeding in normal weight women; but there is a lack of evidence on its effectiveness in overweight women. Our purpose is to evaluate a new approach to exclusive breastfeeding counselling based on Carl Rogers' Centred-Client Theory in overweight women, and to examine effects on breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss.
Methods


A two-arm simple randomized controlled trial will be conducted in overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia. The intervention is exclusive breastfeeding counselling based on Rogers' theory but adapted for overweight women; it will be performed during the last month of pregnancy, 24 h after delivery and during early infancy (1 and 3 months postpartum). The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels. Intention to treat analysis will be performed to estimate the effect of the new counselling approach compared to standard management on the prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss.
Discussion


We hypothesize that the intervention will result in an increase in the initiation and maintenance of exclusive breastfeeding, allowing adequate infant growth velocity and maternal weight loss after delivery. It is hoped that the results of this trial will provide evidence to support public health policy on supporting breastfeeding in this vulnerable group of women.
Trial registration


(UTN)  U1111-1228-9913  February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered.",2020,"The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels.","['Overweight or obese women', 'Trial registration\n\n\n(UTN)  U1111-1228-9913  February 20th 2019; ISRCTN15922904February 27th 2019, retrospectively registered', 'overweight women', 'normal weight women', 'overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia', 'overweight or obese women']","['new approach for exclusive breastfeeding counselling', 'Breastfeeding counselling']","['breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss', 'prolactin and macronutrient levels in breast milk and serum prolactin levels', 'breastfeeding prevalence, infant growth velocity and postpartum weight loss', 'exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4\u2009months after delivery', 'prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.0951031,"The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Aldana-Parra', 'Affiliation': '1Departamento de Nutrición y Bioquímica, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Gilma', 'Initials': 'G', 'LastName': 'Olaya', 'Affiliation': '1Departamento de Nutrición y Bioquímica, Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fewtrell', 'Affiliation': '2UCL Great Ormond Street Institute of Child Health, London, UK.'}]",International breastfeeding journal,['10.1186/s13006-019-0249-2']
3046,25294887,Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials.,"BACKGROUND


The EORTC-STBSG coordinated two large trials of adjuvant chemotherapy (CT) in localized high-grade soft tissue sarcoma (STS). Both studies failed to demonstrate any benefit on overall survival (OS). The aim of the analysis of these two trials was to identify subgroups of patients who may benefit from adjuvant CT.
PATIENTS AND METHODS


Individual patient data from two EORTC trials comparing doxorubicin-based CT to observation only in completely resected STS (large resection, R0/marginal resection, R1) were pooled. Prognostic factors were assessed by univariate and multivariate analyses. Patient outcomes were subsequently compared between the two groups of patients according to each analyzed factor.
RESULTS


A total of 819 patients had been enrolled with a median follow-up of 8.2 years. Tumor size, high histological grade and R1 resection emerged as independent adverse prognostic factors for relapse-free survival (RFS) and OS. Adjuvant CT is an independent favorable prognostic factor for RFS but not for OS. A significant interaction between benefit of adjuvant CT and age, gender and R1 resection was observed for RFS and OS. Males and patients >40 years had a significantly better RFS in the treatment arms, while adjuvant CT was associated with a marginally worse OS in females and patients <40 years. Patients with R1 resection had a significantly better RFS and OS favoring adjuvant CT arms.
CONCLUSION


Adjuvant CT is not associated with a better OS in young patients or in any pathology subgroup. Poor quality of initial surgery is the most important prognostic and predictive factor for utility of adjuvant CT in STS. Based on these data, we conclude that adjuvant CT for STS remains an investigational procedure and is not a routine standard of care.",2014,"A significant interaction between benefit of adjuvant CT and age, gender and R1 resection was observed for RFS and OS.","['young patients or in any pathology subgroup', '819 patients had been enrolled with a median follow-up of 8.2 years', 'Individual patient data from two EORTC trials comparing', 'soft tissue sarcoma', 'subgroups of patients who may benefit from adjuvant CT']","['adjuvant chemotherapy (CT', 'Adjuvant CT', 'Doxorubicin-based adjuvant chemotherapy', 'doxorubicin-based CT']","['RFS and OS', 'Tumor size, high histological grade and R1 resection', 'overall survival (OS', 'RFS']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456201', 'cui_str': 'Histological grades (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",819.0,0.0902753,"A significant interaction between benefit of adjuvant CT and age, gender and R1 resection was observed for RFS and OS.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Department of Medical Oncology and Surgery, Institut Gustave Roussy, Villejuif, France. Electronic address: axel.lecesne@gustaveroussy.fr.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ouali', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Leahy', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Surgical Oncology, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgical Oncology, Charité Universitaetsmedizin BerlinCampus, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Van Coevorden', 'Affiliation': 'Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue and Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Van Hoesel', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Verweij', 'Affiliation': 'Department of Oncology, Erasmus University Medical Center-Cancer Institute, Rotterdam.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bonvalot', 'Affiliation': 'Department of Medical Oncology and Surgery, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Steward', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'P C W', 'Initials': 'PCW', 'LastName': 'Hogendoorn', 'Affiliation': 'Department of Pathology, University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Litiere', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Radio-Oncology, University Claude Bernard Lyon I and Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'W T A', 'Initials': 'WTA', 'LastName': 'Van Der Graaf', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu460']
3047,25281710,Pemetrexed versus gefitinib as a second-line treatment in advanced nonsquamous nonsmall-cell lung cancer patients harboring wild-type EGFR (CTONG0806): a multicenter randomized trial.,"BACKGROUND


CTONG0806 assessed the efficacy of pemetrexed versus gefitinib as second-line treatment in advanced nonsquamous nonsmall-cell lung cancer (NSCLC) harboring wild-type epidermal growth factor receptor (EGFR).
PATIENTS AND METHODS


Patients with locally advanced or metastatic nonsquamous NSCLC harboring wild-type EGFR, detected by direct sequencing, and previously treated with platinum-based chemotherapy were randomized to receive gefitinib (250 mg/day) orally or pemetrexed (500 mg/m(2)) i.v. on day 1 of a 21-day cycle until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). The Independent Review Committee (IRC) evaluated all pictorial data.
RESULTS


From February 2009 to August 2012, 161 patients were enrolled, and 157 were assessable (81 in the gefitinib arm, 76 in the pemetrexed arm). Baseline characteristics were balanced between the two arms. The median PFSs were 4.8 versus 1.6 months in the pemetrexed and gefitinib arms, respectively [hazard ratio (HR) 0.54, 95% confidence interval (CI) 0.40-0.75, P < 0.001] as confirmed by IRC evaluation (5.6versus 1.7 months, HR 0.53, 95% CI 0.38-0.75, P < 0.001). The median overall survival (OS) showed a trend of superiority in the pemetrexed arm (12.4 versus 9.6 months, HR 0.72, 95% CI 0.49-1.04, P = 0.077). Quality-of-life assessment showed no marked difference between the arms. No unexpected adverse events were found. Of 108 patients with sufficient DNA samples, EGFR mutation status was re-tested by Scorpion amplification refractory mutation system (ARMS); 32 (29.6%) tested positive (19 in the pemetrexed arm, 13 in the gefitinib arm; median PFS: 8.1 versus 7.0 months, HR 0.94, 95% CI 0.43-2.08, P = 0.877).
CONCLUSIONS


CTONG0806 is the first trial to show significant improvement in PFS and an improved OS trend with pemetrexed compared with gefitinib as second-line setting treatment of EGFR wild-type advanced nonsquamous NSCLC. ARMS is superior to direct sequencing in excluding false-negative patients.
CLINICALTRIALSGOV IDENTIFIER


NCT00891579.",2014,"The median overall survival (OS) showed a trend of superiority in the pemetrexed arm (12.4 versus 9.6 months, HR 0.72, 95% CI 0.49-1.04, P = 0.077).","['108 patients with sufficient DNA samples', 'advanced nonsquamous nonsmall-cell lung cancer (NSCLC) harboring wild-type epidermal growth factor receptor (EGFR', 'From February 2009 to August 2012, 161 patients were enrolled, and 157 were assessable (81 in the gefitinib arm, 76 in the pemetrexed arm', 'Patients with locally advanced or metastatic nonsquamous NSCLC harboring wild-type EGFR, detected by direct sequencing, and previously treated with platinum-based chemotherapy', 'advanced nonsquamous nonsmall-cell lung cancer patients harboring wild-type EGFR (CTONG0806']","['ARMS', 'gefitinib', 'Pemetrexed versus gefitinib', 'pemetrexed versus gefitinib', 'pemetrexed']","['Quality-of-life assessment', 'EGFR mutation status', 'unacceptable toxicity', 'PFS', 'adverse events', 'median overall survival (OS', 'median PFSs', 'progression-free survival (PFS']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}]","[{'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",161.0,0.187248,"The median overall survival (OS) showed a trend of superiority in the pemetrexed arm (12.4 versus 9.6 months, HR 0.72, 95% CI 0.49-1.04, P = 0.077).","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Pulmonary Oncology, Jilin Provincial Cancer Hospital, Changchun.'}, {'ForeName': 'J-J', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'M-F', 'Initials': 'MF', 'LastName': 'Zhao', 'Affiliation': 'Department of Medical Oncology, The First Hospital of China Medical University, Shenyang.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine, Perking Union Medical Hospital, Beijing.'}, {'ForeName': 'X-C', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'Z-H', 'Initials': 'ZH', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'H-H', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing.'}, {'ForeName': 'J-H', 'Initials': 'JH', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, Hunan Cancer Hospital, Changsha.'}, {'ForeName': 'W-N', 'Initials': 'WN', 'LastName': 'Feng', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'C-R', 'Initials': 'CR', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'W-Z', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou.'}, {'ForeName': 'Y-P', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, The First Hospital of China Medical University, Shenyang.'}, {'ForeName': 'Y-L', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou. Electronic address: syylwu@live.cn.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu463']
3048,25223482,Survival after neoadjuvant chemotherapy with or without bevacizumab or everolimus for HER2-negative primary breast cancer (GBG 44-GeparQuinto)†.,"BACKGROUND


The GeparQuinto study showed that adding bevacizumab to 24 weeks of anthracycline-taxane-based neoadjuvant chemotherapy increases pathological complete response (pCR) rates overall and specifically in patients with triple-negative breast cancer (TNBC). No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients. Here, we present disease-free (DFS) and overall survival (OS) analyses.
PATIENTS AND METHODS


Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab every 3 weeks before surgery. Patients without clinical response to EC ± Bevacizumab were randomized to 12 weekly cycles paclitaxel with or without everolimus 5 mg/day. To detect a hazard ratio (HR) of 0.75 (α = 0.05, β = 0.8) 379 events had to be observed in the bevacizumab arms.
RESULTS


With a median follow-up of 3.8 years, 3-year DFS was 80.8% and 3-year OS was 89.7%. Outcome was not different for patients receiving bevacizumab (HR 1.03; P = 0.784 for DFS and HR 0.974; P = 0.842 for OS) compared with patients receiving chemotherapy alone. Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab. No other predefined subgroup (HR+/HER2-; locally advanced (cT4 or cN3) or not; cT1-3 or cT4; pCR or not) showed a significant benefit. No difference in DFS (HR 0.997; P = 0.987) and OS (HR 1.11; P = 0.658) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups.
CONCLUSIONS


Long-term results, in opposite to the results of pCR, do not support the neoadjuvant use of bevacizumab in addition to an anthracycline-taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients.
CLINICAL TRIAL NUMBER


NCT 00567554, www.clinicaltrials.gov.",2014,Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab.,"['HER2-negative primary breast cancer (GBG 44-GeparQuinto)†', 'Patients (n = 1948) with HER2-negative tumors of a median tumor size of 4 cm', 'patients with triple-negative breast cancer (TNBC']","['anthracycline-taxane-based chemotherapy or everolimus', 'paclitaxel', 'epirubicin/cyclophosphamide followed by docetaxel (EC-T) with or without eight infusions of bevacizumab', 'neoadjuvant chemotherapy with or without bevacizumab or everolimus', 'bevacizumab', 'paclitaxel with or without everolimus', 'EC ± Bevacizumab', 'anthracycline-taxane-based neoadjuvant chemotherapy']","['Survival', 'DFS', '3-year OS', 'hazard ratio (HR', '3-year DFS', 'disease-free (DFS) and overall survival (OS) analyses', 'pCR rate']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0036883', 'cui_str': 'Sex Steroid-Binding Protein'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}]","[{'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038953', 'cui_str': 'Survival Analysis'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",,0.0727012,Patients with TNBC similarly showed no improvement in DFS (HR = 0.99; P = 0.941) and OS (HR = 1.02; P = 0.891) when treated with bevacizumab.,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'Headquarter, German Breast Group, Neu-Isenburg; Department of Gynaecology and Obstetrics, University Hospital, Frankfurt. Electronic address: gunter.vonminckwitz@germanbreastgroup.de.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Headquarter, German Breast Group, Neu-Isenburg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Gynaecology and Obstetrics, Klinikum Berlin-Buch, Berlin.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eidtmann', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Kiel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': 'Breast Center, Luisenkrankenhaus, Düsseldorf.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Erlangen.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Department of Medical Oncology, Chop GmbH, Frankfurt.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eggemann', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Magdeburg.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Schrader', 'Affiliation': 'Department of Gynaecology and Obstetrics, Henriettenstiftung, Hannover.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kittel', 'Affiliation': 'Department of Gynaecology and Obstetrics, Praxisklinik, Berlin.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Department of Gynaecology and Obstetrics, Rot-Kreuz-Klinikum, München.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Ulm.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solbach', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Frankfurt.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Department of Gynaecology and Obstetrics, Sana-Klinikum, Offenbach.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kunz', 'Affiliation': 'Department of Gynaecology and Obstetrics, St Johannes Hospital, Dortmund.'}, {'ForeName': 'J U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Department of Gynaecology and Obstetrics, St Gertrauden-Hospital, Berlin.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hauschild', 'Affiliation': 'Department of Gynaecology and Obstetrics, Hospital, Rheinfelden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Tübingen.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'Headquarter, German Breast Group, Neu-Isenburg.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Hospital, Rostock, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gnauert', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Heinrich', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Prätz', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Groh', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tanzer', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Villena', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tulusan', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Liedtke', 'Affiliation': ''}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kittel', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mau', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schilling', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Just', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bückner', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wolfgarten', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lorenz', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Doering', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Feidicker', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Krabisch', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Deichert', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Augustin', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kunz', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kast', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Nestle-Krämling', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rezai', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Höß', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Terhaag', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fasching', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Staib', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Aktas', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Khandan', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Solbach', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Heinrich', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdallah', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dewitz', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Emons', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Belau', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Rethwisch', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lantzsch', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thomssen', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mattner', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nugent', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Noesselt', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Holms', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Müller', 'Affiliation': ''}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Deuker', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Schrader', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Strumberg', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Uleer', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Solomayer', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Runnebaum', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Link', 'Affiliation': ''}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Tomé', 'Affiliation': ''}, {'ForeName': 'H-U', 'Initials': 'HU', 'LastName': 'Ulmer', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Conrad', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Feisel-Schwickardi', 'Affiliation': ''}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eidtmann', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Steinmetz', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Bauerfeind', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kremers', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Langanke', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kullmer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ober', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fischer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kohls', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Weikel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bischoff', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Freese', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wiest', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sütterlin', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Grießhammer', 'Affiliation': ''}, {'ForeName': 'D-M', 'Initials': 'DM', 'LastName': 'Burgmann', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Salat', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tio', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'von Abel', 'Affiliation': ''}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Christensen', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Burkamp', 'Affiliation': ''}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Köhne', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Meinerz', 'Affiliation': ''}, {'ForeName': 'S-T', 'Initials': 'ST', 'LastName': 'Graßhoff', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Overkamp', 'Affiliation': ''}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Thalmann', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sallmann', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Beck', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bartzke', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deryal', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weigel', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': ''}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Weder', 'Affiliation': ''}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Steffens', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lemster', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stefek', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ruhland', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hofmann', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Simon', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Kronawitter', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemens', 'Affiliation': ''}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Latos', 'Affiliation': ''}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roßmann', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bauer', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lampe', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Heyl', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hoffmann', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lorenz-Salehi', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hackmann', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Schlag', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu455']
3049,25294886,Prognostic value of KRAS mutations in stage III colon cancer: post hoc analysis of the PETACC8 phase III trial dataset.,"BACKGROUND


The prognostic value of KRAS mutations in colon adenocarcinoma is controversial. We examined this question as an ancillary study of the PETACC8 phase III trial.
PATIENTS AND METHODS


We analyzed the prognostic impact of KRAS exon 2 mutations in stage III colon cancer patients (n = 1657) receiving adjuvant FOLFOX ± cetuximab therapy included in the PETACC8 trial. Patients with BRAF-mutated cancers were excluded and, as no difference was found for time to recurrence (TTR) and disease-free survival (DFS) between treatment arms, both were pooled for analysis. Associations with TTR and DFS were analyzed using a Cox proportional hazards model.
RESULTS


KRAS mutations were found in 638 of 1657 tumors and linked to shorter TTR (P < 0.001). However, when specific mutations were compared with wild-type, codon 12 mutations [hazard ratio (HR) 1.67, 95% confidence interval (CI) 1.35-2.04; P < 0.001] but not codon 13 (HR 1.23, 95% CI 0.85-1.79; P = 0.26) were significantly associated with shorter TTR, independently of other covariates. The interaction test showed that, regarding tumor location (distal versus proximal), KRAS genotype affects differently on recurrence (P = 0.02) and DFS (P = 0.042). Subgroup analysis showed that KRAS only affected TTR and DFS in distal tumors (n = 1043; 692 wild type; 351 mutated), with an increased risk of relapse (HR 1.96, 95% CI 1.51-2.56; P < 0.0001) for KRAS codon 12 mutations and a borderline significance for codon 13 mutations (HR 1.59, 95% CI 1.00-2.56; P = 0.051).
CONCLUSION


KRAS exon 2 mutations are independent predictors of shorter TTR in patients with resected stage III distal colon cancers receiving adjuvant therapy. Future clinical trials in the adjuvant setting should consider both the tumor location and KRAS mutations as important stratification factors.
CLINICAL TRIAL NUMBER


This is an ancillary study of the PETACC8 trial: EUDRACT 2005-003463-23.",2014,KRAS exon 2 mutations are independent predictors of shorter TTR in patients with resected stage III distal colon cancers receiving adjuvant therapy.,"['stage III colon cancer', 'exon 2 mutations in stage III colon cancer patients (n = 1657) receiving', 'patients with resected stage III distal colon cancers receiving adjuvant therapy']","['adjuvant FOLFOX ± cetuximab therapy', 'KRAS']","['TTR and DFS in distal tumors', 'time to recurrence (TTR) and disease-free survival (DFS', 'risk of relapse']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.13094,KRAS exon 2 mutations are independent predictors of shorter TTR in patients with resected stage III distal colon cancers receiving adjuvant therapy.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Blons', 'Affiliation': 'UMR-S1147, INSERM, Paris; Paris Descartes University, Paris; APHP Department of Biology, Georges Pompidou Hospital, Paris.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Emile', 'Affiliation': 'Department of Pathology, APHP Ambroise Paré Hospital, Boulogne-Billancourt; Paris-Ouest University, Versailles Saint-Quentin.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Le Malicot', 'Affiliation': 'Department of Statistics, Fédération Francophone de Cancérologie Digestive, Dijon.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Julié', 'Affiliation': 'Department of Pathology, APHP Ambroise Paré Hospital, Boulogne-Billancourt.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaanan', 'Affiliation': 'APHP Department of Hepatogastroenterology and GI Oncology, Georges Pompidou Hospital, Paris, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': '1st Medical Department, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'Deptartment of Gastroenterology, Erasme University Hospital, Brussels, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Thaler', 'Affiliation': 'Department of Internal Medicine IV, Klinikum Wels-Grieskirchen, Wels, Austria.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, University College London, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nørgård-Petersen', 'Affiliation': 'Department of Oncology, Rigshospitalet, København, Denmark.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Digestive Oncology, University Hospitals and KULeuven, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'Department of Hepato-Gastroenterology, Dijon University Hospital and INSERM U 866, Dijon.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Zawadi', 'Affiliation': 'GI Oncology, Les Oudairies Hospital, La Roche sur Yon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salazar', 'Affiliation': 'Catalan Institute of Oncology (IDIBELL), Barcelona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'UMR-S1147, INSERM, Paris; Paris Descartes University, Paris; APHP Department of Biology, Georges Pompidou Hospital, Paris.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'APHP Department of Hepatogastroenterology and GI Oncology, Georges Pompidou Hospital, Paris, France; Paris Descartes University, Paris. Electronic address: julien.taieb@egp.aphp.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu464']
3050,31952627,Changes in DSM criteria following a culturally-adapted computerized CBT for Spanish-speaking individuals with substance use disorders.,"This study sought to replicate and extend findings regarding change in the number of endorsed Diagnostic and Statistical Manual (DSM) criteria for substance use disorders as a meaningful outcome for clinical trials with Spanish-speakers. A secondary analysis was conducted of data from 83 treatment-seeking individuals with current DSM-IV substance dependence participating in a randomized controlled trial evaluating a culturally-adapted version of a computer-based cognitive behavioral therapy program (CBT4CBT) for Spanish-speakers. Participants were randomized to either weekly standard outpatient counseling (treatment as usual - TAU), or TAU plus access to CBT4CBT (TAU+CBT4CBT). The Structured Clinical Interview for DSM-IV (SCID-IV) was administered at baseline and at the end of the 8-week treatment period to measure change in diagnostic status and total criteria count. Frequency of substance use during treatment and throughout a 6-month follow-up period was measured by self-report using a calendar-based Timeline FollowBack method, with abstinence verified through instant urine toxicology, and problem severity was measured with the Addiction Severity Index (ASI). Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X 2  = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X 2  = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only. Total criteria count and diagnostic status at end-of-treatment was significantly correlated with substance use outcomes during the follow-up period, such that fewer criteria endorsed were associated with greater rates of abstinence and lower problem severity. These findings paralleled the primary outcomes from the main trial, and replicated prior findings in English-speakers regarding the utility of DSM criteria count as a potential clinically meaningful outcome.",2020,"Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X 2  = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X 2  = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only.","['Spanish-speakers', '83 treatment-seeking individuals with current DSM-IV substance dependence participating']","['standard outpatient counseling (treatment as usual - TAU), or TAU plus access to CBT4CBT (TAU+CBT4CBT', 'culturally-adapted version of a computer-based cognitive behavioral therapy program (CBT4CBT', 'TAU+CBT4CBT']","['Total criteria count and diagnostic status', 'Addiction Severity Index (ASI', 'rates of abstinence and lower problem severity', 'total count of DSM-IV dependence criteria']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0038580', 'cui_str': 'Substance Dependence'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]",83.0,0.0259403,"Results of a generalized linear model with Poisson's distribution indicated significant reduction in the total count of DSM-IV dependence criteria during treatment (Wald X 2  = 136.20; p < .001), and a significant interaction with treatment assignment (Wald X 2  = 19.92, p < .001), indicating a greater reduction in endorsed criteria for those assigned to TAU+CBT4CBT compared to TAU only.","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Silva', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Yudilyn', 'Initials': 'Y', 'LastName': 'Jaramillo', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Añez-Nava', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, 40 Temple St (Suite 6C), New Haven, CT 06510, United States of America. Electronic address: Brian.kiluk@yale.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.12.006']
3051,31990089,"Efficacy of Fractional CO 2  Laser, Promestriene, and Vaginal Lubricant in the Treatment of Urinary Symptoms in Postmenopausal Women: A Randomized Clinical Trial.","BACKGROUND AND OBJECTIVES


Evaluating the efficacy of the fractional CO 2  laser, promestriene, and vaginal lubricant to treat urinary symptoms in women with genitourinary syndrome of menopause.
STUDY DESIGN/MATERIALS AND METHODS


We conducted a randomized clinical trial with 72 postmenopausal women aged 50 years or older. The participants were randomized to one intervention each in three treatment groups fractional CO 2  laser, promestriene, and vaginal lubricant. Urinary symptoms were assessed prior to treatment and 2 weeks after treatment completion using validated questionnaires, the International Consultation on Incontinence Questionnaire (ICIQ-UI SF), and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB).
RESULTS


There was a significant reduction in the total ICIQ-UI SF score in the intragroup comparison (baseline vs. week 14) of the CO 2  laser group (P = 0.004). This group also showed a statistically significant reduction in nocturia (1.33 ± 0.87 vs. 1.00 ± 0.76, respectively; P = 0.031). In the intergroup comparison after treatment, nocturia in the lubricant group had worsened compared with that of the other two groups (P = 0.002). Regarding the total ICIQ-OAB score, the results of the CO 2  laser group were superior to those of the lubricant group in the intergroup comparison (7.76 ± 3.36, P = 0.020; analysis of variance P = 0.038).
CONCLUSION


The results were significantly different between the intravaginal fractional CO 2  laser and topical estrogen groups for treating urinary symptoms related to the genitourinary syndrome of menopause. Further controlled and randomized studies are needed. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.",2020,The results were significantly different between the intravaginal fractional CO 2  laser and topical estrogen groups for treating urinary symptoms related to the genitourinary syndrome of menopause.,"['72 postmenopausal women aged 50 years or older', 'Postmenopausal Women', 'women with genitourinary syndrome of menopause']","['Fractional CO 2  Laser, Promestriene, and Vaginal Lubricant', 'fractional CO 2  laser, promestriene, and vaginal lubricant']","['Urinary symptoms', 'nocturia', 'total ICIQ-OAB score', 'total ICIQ-UI SF score', 'Incontinence Questionnaire (ICIQ-UI SF), and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0072151', 'cui_str': 'promestriene'}, {'cui': 'C0356770', 'cui_str': 'Vaginal lubricant'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire (assessment scale)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]",72.0,0.0701222,The results were significantly different between the intravaginal fractional CO 2  laser and topical estrogen groups for treating urinary symptoms related to the genitourinary syndrome of menopause.,"[{'ForeName': 'Luiza Borges', 'Initials': 'LB', 'LastName': 'Aguiar', 'Affiliation': 'Department of Obstetrics and Gynecology, State University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Carlos Alberto', 'Initials': 'CA', 'LastName': 'Politano', 'Affiliation': 'Department of Obstetrics and Gynecology, State University of Campinas, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Lúcia', 'Initials': 'L', 'LastName': 'Costa-Paiva', 'Affiliation': 'Department of Gynecology and Obstetrics, State University of Campinas, Rua Alexandre Fleming, 101, Campinas, São Paulo, CEP 13083-881, Brazil.'}, {'ForeName': 'Cássia Raquel Teatin', 'Initials': 'CRT', 'LastName': 'Juliato', 'Affiliation': 'Department of Obstetrics and Gynecology, State University of Campinas, Campinas, São Paulo, Brazil.'}]",Lasers in surgery and medicine,['10.1002/lsm.23220']
3052,21464154,A phase III randomized study of gemcitabine and cisplatin with or without PF-3512676 (TLR9 agonist) as first-line treatment of advanced non-small-cell lung cancer.,"BACKGROUND


This open-label phase III study assessed the addition of Toll-like receptor 9-activating oligodeoxynucleotide PF-3512676 to gemcitabine/cisplatin chemotherapy in patients with non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS


Chemotherapy-naive patients with stage IIIB or IV NSCLC were randomized (1:1) to receive six or fewer 3-week cycles of i.v. gemcitabine (1250 mg/m2 on days 1 and 8) and cisplatin alone (75 mg/m2 on day 1, control arm) or combined with s.c. PF-3512676 0.2 mg/kg on days 8 and 15 of each chemotherapy cycle and weekly thereafter until progression or unacceptable toxicity (experimental arm). No crossover was planned. The primary end point was overall survival (OS).
RESULTS


A total of 839 patients were randomized. Baseline demographics were well balanced. Median OS (11.0 versus 10.7 months; P=0.98) and median progression-free survival (PFS) (both 5.1 months) were similar between groups. Grade≥3 hematologic adverse events (AEs), injection-site reactions, and influenza-like symptoms were more frequently reported among patients receiving PF-3512676. At the first-interim analysis, the Data Safety Monitoring Committee recommended study discontinuation. Administration of PF-3512676 was halted based on efficacy futility and increased grade≥3 AEs (experimental arm).
CONCLUSIONS


Addition of PF-3512676 to gemcitabine/cisplatin chemotherapy did not improve OS or PFS but did increase toxicity.",2012,"CONCLUSIONS


Addition of PF-3512676 to gemcitabine/cisplatin chemotherapy did not improve OS or PFS but did increase toxicity.","['839 patients were randomized', 'Chemotherapy-naive patients with stage IIIB or IV NSCLC', 'advanced non-small-cell lung cancer', 'patients with non-small-cell lung cancer (NSCLC']","['gemcitabine', 'cisplatin alone', 'gemcitabine/cisplatin chemotherapy', 'PF-3512676', 'PF-3512676 to gemcitabine/cisplatin chemotherapy', 'gemcitabine and cisplatin with or without PF-3512676 (TLR9 agonist']","['toxicity', 'OS or PFS', 'median progression-free survival (PFS', 'overall survival (OS', 'efficacy futility and increased grade≥3 AEs', 'Median OS', 'Grade≥3 hematologic adverse events (AEs), injection-site reactions, and influenza-like symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2000258', 'cui_str': 'PF 3512676'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms (finding)'}]",839.0,0.118869,"CONCLUSIONS


Addition of PF-3512676 to gemcitabine/cisplatin chemotherapy did not improve OS or PFS but did increase toxicity.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Manegold', 'Affiliation': 'Interdisciplinary Thoracic Oncology, Department of Surgery, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany. Electronic address: Prof.Manegold@t-online.de.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'van Zandwijk', 'Affiliation': 'Bernie Banton Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Szczesna', 'Affiliation': '3rd Department, Regional Lung Diseases Hospital, Otwock, Poland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zatloukal', 'Affiliation': '3rd Faculty of Medicine, Charles University, Faculty Hospital Bulovka and Postgraduate Medical Institute, Prague, Czech Republic.'}, {'ForeName': 'J S K', 'Initials': 'JSK', 'LastName': 'Au', 'Affiliation': 'Department of Clinical Oncology, Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blasinska-Morawiec', 'Affiliation': 'Department of Proliferative Diseases, Copernicus Memorial Hospital, Lodz.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Serwatowski', 'Affiliation': 'Chemotherapy Department, Specialistic Hospital Named After Professor A. Sokolowski, Szczecin-Zdunowo.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Krzakowski', 'Affiliation': 'Lung and Thoracic Tumours Department, Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jassem', 'Affiliation': 'Department of Oncology and Radiology, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'E H', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Department of Medical Oncology, National Cancer Centre, Singapore.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Benner', 'Affiliation': 'Pfizer Global Research and Development, New London, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ingrosso', 'Affiliation': 'Pfizer Global Research and Development, Milan, Italy.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Meech', 'Affiliation': 'Pfizer Global Research and Development, New London, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Readett', 'Affiliation': 'Pfizer Global Research and Development, New London, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Thatcher', 'Affiliation': 'Department of Medical Oncology, Christie Hospital, Manchester, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr030']
3053,21464158,A cytokine and angiogenic factor (CAF) analysis in plasma for selection of sorafenib therapy in patients with metastatic renal cell carcinoma.,"BACKGROUND


We investigated cytokines and angiogenic factors (CAFs) in patients with metastatic renal cell carcinoma (mRCC) treated in a randomized phase II clinical trial of sorafenib versus sorafenib+ interferon-α (IFN-α) that yielded no differences in progression-free survival (PFS). We aimed to link the CAF profile to PFS and select candidate predictive and prognostic markers for further study.
METHODS


The concentrations of 52 plasma CAFs were measured pretreatment (n = 69), day 28, and day 56 using multiplex bead arrays and enzyme-linked immunosorbent assay. We investigated the association between baseline levels of CAFs with PFS and posttreatment changes.
RESULTS


Unsupervised CAF clustering analysis revealed two distinct mRCC patient groups with elevated proangiogenic or proinflammatory mediators. A six-marker baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand] correlated with PFS benefit (hazard ratio 0.20 versus 2.25, signature negative versus positive, respectively; P = 0.0002). While changes in angiogenic factors were frequently attenuated by the sorafenib+ IFN combination, most key immunomodulatory mediators increased.
CONCLUSIONS


Using CAF profiling, we identified two mRCC patient groups, a candidate plasma signature for predicting PFS benefit, and distinct marker changes occurring with each treatment. This platform may provide valuable insights into renal cell carcinoma biology and the molecular consequences of targeted therapies.",2012,"A six-marker baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand] correlated with PFS benefit (hazard ratio 0.20 versus 2.25, signature negative versus positive, respectively; P = 0.0002).","['patients with metastatic renal cell carcinoma', 'patients with metastatic renal cell carcinoma (mRCC']","['sorafenib therapy', 'sorafenib versus sorafenib+ interferon-α (IFN-α']","['baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand', 'angiogenic factors', 'elevated proangiogenic or proinflammatory mediators', 'progression-free survival (PFS', 'concentrations of 52 plasma CAFs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C4255077', 'cui_str': 'CAIX Protein'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0002976', 'cui_str': 'Angiogenesis Factor'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",69.0,0.114691,"A six-marker baseline CAF signature [osteopontin, vascular endothelial growth factor (VEGF), carbonic anhydrase 9, collagen IV, VEGF receptor-2, and tumor necrosis factor-related apoptosis-inducing ligand] correlated with PFS benefit (hazard ratio 0.20 versus 2.25, signature negative versus positive, respectively; P = 0.0002).","[{'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Zurita', 'Affiliation': 'Departments of Genitourinary Medical Oncology. Electronic address: azurita@mdanderson.org.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jonasch', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khajavi', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'D Z', 'Initials': 'DZ', 'LastName': 'Du', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Herynk', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'McKee', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Tran', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Logothetis', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Departments of Genitourinary Medical Oncology.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Heymach', 'Affiliation': 'Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr047']
3054,21471562,"Impact of a novel nurse-led prechemotherapy education intervention (ChemoEd) on patient distress, symptom burden, and treatment-related information and support needs: results from a randomised, controlled trial.","BACKGROUND


High levels of distress and need for self-care information by patients commencing chemotherapy suggest that current prechemotherapy education is suboptimal. We conducted a randomised, controlled trial of a prechemotherapy education intervention (ChemoEd) to assess impact on patient distress, treatment-related concerns, and the prevalence and severity of and bother caused by six chemotherapy side-effects.
PATIENTS AND METHODS


One hundred and ninety-two breast, gastrointestinal, and haematologic cancer patients were recruited before the trial closing prematurely (original target 352). ChemoEd patients received a DVD, question-prompt list, self-care information, an education consultation≥24 h before first treatment (intervention 1), telephone follow-up 48 h after first treatment (intervention 2), and a face-to-face review immediately before second treatment (intervention 3). Patient outcomes were measured at baseline (T1: pre-education) and immediately preceding treatment cycles 1 (T2) and 3 (T3).
RESULTS


ChemoEd did not significantly reduce patient distress. However, a significant decrease in sensory/psychological (P=0.027) and procedural (P=0.03) concerns, as well as prevalence and severity of and bother due to vomiting (all P=0.001), were observed at T3. In addition, subgroup analysis of patients with elevated distress at T1 indicated a significant decrease (P=0.035) at T2 but not at T3 (P=0.055) in ChemoEd patients.
CONCLUSIONS


ChemoEd holds promise to improve patient treatment-related concerns and some physical/psychological outcomes; however, further research is required on more diverse patient populations to ensure generalisability.",2012,"However, a significant decrease in sensory/psychological (P=0.027) and procedural (P=0.03) concerns, as well as prevalence and severity of and bother due to vomiting (all P=0.001), were observed at T3.","['One hundred and ninety-two breast, gastrointestinal, and haematologic cancer patients were recruited before the trial closing prematurely (original target 352']","['novel nurse-led prechemotherapy education intervention (ChemoEd', 'prechemotherapy education intervention (ChemoEd']","['prevalence and severity of and bother due to vomiting', 'patient distress', 'sensory/psychological']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",,0.222963,"However, a significant decrease in sensory/psychological (P=0.027) and procedural (P=0.03) concerns, as well as prevalence and severity of and bother due to vomiting (all P=0.001), were observed at T3.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aranda', 'Affiliation': 'Department of Nursing and Supportive Care Research, Peter MacCallum Cancer Centre, Melbourne; Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne. Electronic address: sanchiaa@unimelb.edu.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jefford', 'Affiliation': 'Department of Nursing and Supportive Care Research, Peter MacCallum Cancer Centre, Melbourne; Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Yates', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gough', 'Affiliation': 'Department of Nursing and Supportive Care Research, Peter MacCallum Cancer Centre, Melbourne.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Seymour', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne; Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Francis', 'Affiliation': 'Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Baravelli', 'Affiliation': 'Department of Nursing and Supportive Care Research, Peter MacCallum Cancer Centre, Melbourne.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breen', 'Affiliation': 'Department of Nursing and Supportive Care Research, Peter MacCallum Cancer Centre, Melbourne; Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Department of Nursing and Supportive Care Research, Peter MacCallum Cancer Centre, Melbourne; Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr042']
3055,30316534,Effect of vitamin D supplementation on depression in elderly patients: A randomized clinical trial.,"BACKGROUND & AIMS


Treatment of depression in elderly population is a crucial issue. The effect of vitamin D supplementation on treatment of depression in older adults was investigated in this clinical trial.
METHODS


It was an 8-week, randomized clinical trial of vitamin D supplementation and placebo in the treatment of depression in 3 psychiatric clinics. The study sample included 78 older adults aged over 60 years with moderate to severe depression. Subjects were randomly allocated to receive 50,000 U vitamin D3 pearl weekly for 8 weeks or placebo (39 subjects in each group). Main outcome measures comprised Geriatric Depression Scale-15 (GDS-15) questionnaire and 25-hydroxyvitamin D3 [25(OH)D3]. The analysis utilized Mann Whitney U test, Wilcoxon signed ranks test, chi-square and multiple regression analysis.
RESULTS


The mean baseline 25(OH)D3 concentration was 22.57 ± 6.2 ng/ml in vitamin D group and 21.2 ± 5.8 ng/ml in placebo group (p = 0.16). The Vitamin D increased to 43.48 ± 9.5 ng/ml in vitamin D and 25.9 ± 15.3 ng/ml in placebo group. The depression score decreased from 9.25 to 7.48 in vitamin D group (p = 0.0001), while there was a non-significant increase in depression score in placebo group. The multiple regression analysis showed that the vitamin D group and the score of depression before study were the variables that could explain 81.8% of depression score after intervention.
CONCLUSION


The findings indicated that vitamin D supplementation can improve the depression score in persons aged 60 and over.",2019,"The depression score decreased from 9.25 to 7.48 in vitamin D group (p = 0.0001), while there was a non-significant increase in depression score in placebo group.","['78 older adults aged over 60 years with moderate to severe depression', '3 psychiatric clinics', 'older adults', 'elderly population', 'elderly patients']","['vitamin D', 'vitamin D supplementation and placebo', 'vitamin D supplementation', 'placebo', '50,000\xa0U vitamin D3 pearl weekly for 8 weeks or placebo']","['Vitamin D', 'depression score', 'mean baseline 25(OH)D3 concentration', 'Geriatric Depression Scale-15 (GDS-15) questionnaire and 25-hydroxyvitamin D3 [25(OH)D3']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]",78.0,0.49143,"The depression score decreased from 9.25 to 7.48 in vitamin D group (p = 0.0001), while there was a non-significant increase in depression score in placebo group.","[{'ForeName': 'Negin Masoudi', 'Initials': 'NM', 'LastName': 'Alavi', 'Affiliation': 'Trauma Nursing Research Center, Kashan University of Medical Sciences, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Khademalhoseini', 'Affiliation': 'Trauma Nursing Research Center, Kashan University of Medical Sciences, Iran. Electronic address: saeedkhadem1251369@yahoo.com.'}, {'ForeName': 'Zarichehr', 'Initials': 'Z', 'LastName': 'Vakili', 'Affiliation': 'Department of Pathology, Kashan University of Medical Sciences, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Assarian', 'Affiliation': 'Department of Psychiatry, Kashan University of Medical Sciences, Iran.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.09.011']
3056,31999478,Pharmacokinetics of Faster and Standard Insulin Aspart During Fully Closed-Loop Insulin Delivery in Type 2 Diabetes.,"Background:  Faster insulin aspart is a novel formulation of insulin aspart aiming to accelerate its subcutaneous absorption. The aim of this study was to compare pharmacokinetics of faster insulin aspart versus standard insulin aspart in adults with type 2 diabetes during closed-loop insulin delivery.  Methods:  We assessed the pharmacokinetics of faster and standard insulin aspart from data obtained in a randomized double-blind crossover study evaluating fully closed-loop insulin delivery in adults with type 2 diabetes ( n  = 13, age 59 ± 10 years, BMI 34.5 ± 9.1 kg/m 2 , HbA1c 7.7% ± 1.2% [60 ± 13 mmol/mol]). Blood samples were collected every 15-30 min for 10 h to determine plasma insulin aspart concentration using liquid chromatography mass spectrometry. Time to peak plasma concentration ( T max ) was calculated using a two-compartment model.  Results:   T max  was 68.7 ± 21.6 min for faster aspart and 89.7 ± 31.8 min for aspart (mean paired difference faster aspart minus aspart -15.5 min, 95% CI [-31.6 to 0.6 min],  P  = 0.06). Metabolic clearance rate did not differ between the two insulins ( P  = 0.61). Insulin amount delivered during closed-loop with faster aspart positively correlated with  T max  ( r S  = 0.73,  P  = 0.01), whereas no statistically significant correlation was found with body mass index (BMI), weight or HbA1C (all  P  > 0.18).  Conclusion:  In conclusion,  T max  tended to be shorter for faster aspart versus aspart during fully automated closed-loop insulin delivery and positively correlated with the amount of insulin delivered.",2020,"Insulin amount delivered during closed-loop with FA positively correlated with Tmax (rS=0.73, p=0.01), whereas no statistically significant correlation was found with BMI, weight or HbA1C (all p>0.18).","['adults with type 2 diabetes (n=13, age 59±10yrs, BMI 34.5±9.1kg/m2, HbA1c 7.7±1.2% [60±13mmol/mol', 'adults with type 2 diabetes during closed-loop insulin delivery', 'type 2 diabetes']","['insulin aspart versus standard insulin aspart', ' Faster insulin aspart', 'faster and standard insulin aspart']","['pharmacokinetics of faster (FA) and standard insulin aspart (A', 'Tmax', 'Metabolic clearance rate', 'BMI, weight or HbA1C', 'Time to peak plasma concentration (Tmax']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0025515', 'cui_str': 'Metabolic Clearance Rate'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0799488,"Insulin amount delivered during closed-loop with FA positively correlated with Tmax (rS=0.73, p=0.01), whereas no statistically significant correlation was found with BMI, weight or HbA1C (all p>0.18).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dehais', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Prost', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christos T', 'Initials': 'CT', 'LastName': 'Nakas', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0477']
3057,31992495,The Effect of Pregabalin on the Prevention of Succinylcholine-Induced Fasciculation and Myalgia.,"PURPOSE


This study evaluates the effect of pregabalin on fasciculation and myalgia after using succinylcholine.
DESIGN


This randomized double-blind prospective study was conducted among 100 patients aged 20 to 60 years old.
METHODS


Pregabalin (300 mg) and placebo (in capsule form) were placed in similar containers. The results were analyzed by SPSS 23 software, and statistical analysis consisted of χ 2  test and t test, and a P value less than .05 was considered significant.
FINDINGS


The mean pain score in the group receiving pregabalin was lower than the placebo group. According to the χ 2  test, there was a significant difference between the two groups in the frequency of fasciculation (P = .003). Mean fasciculation severity in the pregabalin group was lower than placebo group. According to t test, there was a significant difference in the mean fasciculation severity between the two groups (P = .002).
CONCLUSIONS


This study showed that 300 mg of pregabalin was effective in reducing postoperative fasciculation and myalgia in patients treated with succinylcholine.",2020,"According to the χ 2  test, there was a significant difference between the two groups in the frequency of fasciculation (P = .003).",['100 patients aged 20 to 60\xa0years old'],"['placebo', 'pregabalin', 'Pregabalin', 'succinylcholine']","['mean pain score', 'mean fasciculation severity', 'Mean fasciculation severity', 'frequency of fasciculation', 'fasciculation and myalgia', 'postoperative fasciculation and myalgia']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0038627', 'cui_str': 'suxamethonium'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015644', 'cui_str': 'Fasciculation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",100.0,0.117874,"According to the χ 2  test, there was a significant difference between the two groups in the frequency of fasciculation (P = .003).","[{'ForeName': 'Shahryar', 'Initials': 'S', 'LastName': 'Sane', 'Affiliation': 'Department of Anesthesiology, Urmia Imam Khomeini Hospital, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Mir Moussa', 'Initials': 'MM', 'LastName': 'Aghdashi', 'Affiliation': 'Department of Anesthesiology, Urmia Imam Khomeini Hospital, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Behzad Kazemi', 'Initials': 'BK', 'LastName': 'Haki', 'Affiliation': 'Department of Anesthesiology, Urmia Imam Khomeini Hospital, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Gholamveisi', 'Affiliation': 'Department of Operating Room, Faculty of Nursing and Midwifery, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Rajabzadeh', 'Affiliation': 'Department of Medicine, Urmia University of Medical Science, Urmia, Iran.'}, {'ForeName': 'Parang', 'Initials': 'P', 'LastName': 'Golabi', 'Affiliation': 'Department of Anesthesiology, Mahabad Imam Khomeini Hospital, Urmia University of Medical Science, Mahabad, Iran. Electronic address: behzad_emt@yahoo.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.11.005']
3058,31964380,Optimal timing of primaquine to reduce Plasmodium falciparum gametocyte carriage when co-administered with artemether-lumefantrine.,"BACKGROUND


Primaquine is an important gametocytocidal drug that is combined with conventional malaria treatment for prevention of Plasmodium falciparum malaria transmission. Primaquine has been administered together on the first or the last day of conventional treatment but the impact of primaquine timing has never been examined. This study aimed to assess safety, efficacy and optimal timing of single full-dose (0.75 mg/kg) primaquine when added to a standard 6-dose regimen of artemether-lumefantrine (AL).
METHODS


In an individual-level randomized controlled trial, enrolled participants who were G6PD normal and had uncomplicated P. falciparum malaria were randomly assigned to receive: AL only; AL and a single 0.75 mg/kg primaquine dose on the first day of AL (day 1); or AL and single 0.75 mg//kg primaquine on the last day of AL (day 3). On days 2, 3, 4, 8, 11 and 15, gametocytes were assessed and quantified by microscope and quantitative nuclear acid sequence based quantification (QT-NASBA).
RESULTS


Overall, 111 participants aged between 3 and 17 years were randomly allocated to receive AL only (36) or combined with primaquine on day 1 (38), or primaquine on day 3 (37). Day 4 gametocyte prevalence in AL + day 1 primaquine was half the level seen in either AL + day 3 primaquine or AL only arm (11% [4/35] vs 26% [8/31] and 27% [8/30], respectively) albeit not statistically significant. A similar trend of lower gametocyte in the AL + day 1 primaquine verses AL + day 3 primaquine or AL only arm was observed in mean gametocyte density. Mean (sd) haemoglobin level in AL + day 3 primaquine arm recovered from -0.42(1.2) g/dl on day 2 to 0.35 (1.5) g/dl on day 15 of follow up. This was not the case in AL only and AL + day 1 primaquine arms during the same follow-up period, although the difference was not statistically significant (p = 318). No serious adverse events reported in the study. Across arms, 23% (26/111) of participants reported a total of 31 mild adverse events and the difference was not statistically significant (p = 0.477).
CONCLUSION


Primaquine administration on the first day of AL is well tolerated and as safe as later administration. Whilst the World Health Organization currently recommends a lower dose of primaquine (0.25 mg/kg), the findings are supportive of early primaquine administration when combined with artemisinin-combination therapy. ClinicalTrials.gov Registration NCT01906788.",2020,No serious adverse events reported in the study.,"['enrolled participants who were G6PD normal and had uncomplicated P. falciparum malaria', '111 participants aged between 3 and 17\xa0years']","['single 0.75\xa0mg/kg primaquine', 'primaquine', 'AL and single 0.75\xa0mg//kg primaquine', 'Primaquine']","['mean gametocyte density', 'safety, efficacy', 'Plasmodium falciparum gametocyte carriage', 'total of 31 mild adverse events', 'Mean (sd) haemoglobin level']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3662566', 'cui_str': 'Gametocyte of Plasmodium falciparum (organism)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",111.0,0.137474,No serious adverse events reported in the study.,"[{'ForeName': 'Seif', 'Initials': 'S', 'LastName': 'Shekalaghe', 'Affiliation': 'Bagamoyo Research and Training Centre (BRTC), Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Mosha', 'Affiliation': 'Bagamoyo Research and Training Centre (BRTC), Ifakara Health Institute, Bagamoyo, Tanzania. dfmosha@hotmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Hamad', 'Affiliation': 'Bagamoyo Research and Training Centre (BRTC), Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Thabit A', 'Initials': 'TA', 'LastName': 'Mbaga', 'Affiliation': 'Bagamoyo Research and Training Centre (BRTC), Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mihayo', 'Affiliation': 'Bagamoyo Research and Training Centre (BRTC), Ifakara Health Institute, Bagamoyo, Tanzania.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'Bousema', 'Affiliation': 'Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Drakeley', 'Affiliation': 'Department of Immunology and Infection, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Abdulla', 'Affiliation': 'Bagamoyo Research and Training Centre (BRTC), Ifakara Health Institute, Bagamoyo, Tanzania.'}]",Malaria journal,['10.1186/s12936-020-3121-3']
3059,31708422,"Intraoperative Ketamine for Analgesia Post-Coronary Artery Bypass Surgery: A Randomized, Controlled, Double-Blind Clinical Trial.","OBJECTIVES


To determine whether the administration of ketamine during coronary artery bypass grafting (CABG) surgery leads to a reduction in the quantity of opioids required over the first 48 hours after surgery.
DESIGN


Randomized, controlled, double-blind clinical trial.
SETTING


Single university academic center.
PARTICIPANTS


Patients undergoing CABG surgery with a normal left ventricular ejection fraction.
INTERVENTIONS


Ketamine administered intravenously as a bolus dose of 0.5 mg/kg before skin incision, followed by an infusion of 0.5 mg/kg/h until the end of surgery.
MEASUREMENTS AND MAIN RESULTS


One hundred eighty-three patients were screened, and 80 patients were randomized. Baseline characteristics were similar between the 2 groups. The intervention group received 53.6 mg (95% confidence interval [CI] 47.1-60.1 mg) of morphine equivalents in the first 48 hours after surgery, whereas the placebo group received 55.7 mg (95% CI 48.4-63.1 mg) over the same time period (p = 0.66). No significant difference was noted in morphine equivalents over the first 6, 12, or 24 hours postoperatively or in maximum, minimum, or average pain scores on postoperative days 1 or 2.
CONCLUSIONS


The administration of ketamine during CABG surgery did not result in reduced opioid consumption or pain scores postoperatively.",2020,"No significant difference was noted in morphine equivalents over the first 6, 12, or 24 hours postoperatively or in maximum, minimum, or average pain scores on postoperative days 1 or 2.
","['Patients undergoing CABG surgery with a normal left ventricular ejection fraction', 'Analgesia Post-Coronary Artery Bypass Surgery', 'One hundred eighty-three patients were screened, and 80 patients were randomized', 'Single university academic center']","['morphine', 'Ketamine', 'ketamine', 'coronary artery bypass grafting (CABG) surgery', 'Intraoperative Ketamine', 'placebo']","['average pain scores', 'reduced opioid consumption or pain scores', 'morphine equivalents']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",183.0,0.778948,"No significant difference was noted in morphine equivalents over the first 6, 12, or 24 hours postoperatively or in maximum, minimum, or average pain scores on postoperative days 1 or 2.
","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cameron', 'Affiliation': 'Department of Anesthesia, Jewish General Hospital, Montreal, Quebec, Canada; Department of Anesthesia, McGill University, Montreal, Quebec, Canada. Electronic address: matthew.cameron@mcgill.ca.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Tam', 'Affiliation': 'Department of Anesthesia, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Al Wahaibi', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Charghi', 'Affiliation': 'Department of Anesthesia, Jewish General Hospital, Montreal, Quebec, Canada; Department of Anesthesia, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Béïque', 'Affiliation': 'Department of Anesthesia, Jewish General Hospital, Montreal, Quebec, Canada; Department of Anesthesia, McGill University, Montreal, Quebec, Canada.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.10.010']
3060,31642731,"Clinical pharmacology of the dual orexin receptor antagonist ACT-541468 in elderly subjects: Exploration of pharmacokinetics, pharmacodynamics and tolerability following single-dose morning and repeated-dose evening administration.","BACKGROUND


The dual orexin receptor antagonist ACT-541468 showed sedative pharmacodynamic effects during initial clinical testing in adult subjects. The present study explored pharmacokinetics, pharmacodynamics and tolerability in healthy elderly subjects.
METHODS


Double-blind, placebo-controlled, randomised, single-ascending dose study in 24 male/female elderly (65-80 years, 5, 15 and 25 mg in the morning, 6/2 active/placebo per group). Additionally, 10 subjects (8/2 active/placebo) received 25 mg for 7 days in the evening. Pharmacokinetics, pharmacodynamics (saccadic peak velocity, adaptive tracking, body sway, visual analogue scales according to Bowdle and Bond and Lader, Karolinska Sleepiness Scale) and tolerability were assessed. In particular, pharmacodynamics results are to be interpreted exploratorily.
RESULTS


Absorption was quick with a median time to maximum concentration of ∼ 1.0 h. The mean elimination half-life was 8.5-9.8 h, the area under the curve and the maximum plasma concentration increased proportionally with dose. Following repeated evening administration of 25 mg, minimal accumulation was observed. There were no pharmacodynamic effects at 5 mg. At 15 mg, saccadic peak velocity (degree/s; SD) was reduced (69; 38), while other variables showed no effects. At 25 mg, effects on all objective pharmacodynamic parameters were observed. At 8-12 h post-dose, there were no differences to placebo and no next-day effects on pharmacodynamic variables after evening administration. Elderly subjects reported fewer adverse events compared to adults in previous studies.
CONCLUSION


ACT-541468 in elderly subjects was well tolerated and pharmacokinetics and pharmacodynamics are compatible with a drug for the treatment of insomnia. Clinicaltrials.gov: NCT02571855.",2020,"At 15 mg, saccadic peak velocity (degree/s; SD) was reduced (69; 38), while other variables showed no effects.","['adult subjects', 'Elderly subjects', 'elderly subjects', '10 subjects (8/2 active', 'healthy elderly subjects', '24 male/female elderly (65-80\u2009years, 5, 15 and 25\u2009mg in the morning, 6/2 active/placebo per group']","['placebo', 'dual orexin receptor antagonist ACT-541468']","['objective pharmacodynamic parameters', 'saccadic peak velocity (degree/s; SD', 'pharmacodynamic variables', 'adverse events', 'pharmacodynamic effects', 'tolerated and pharmacokinetics and pharmacodynamics', 'maximum plasma concentration', 'pharmacokinetics, pharmacodynamics and tolerability', 'sedative pharmacodynamic effects', 'Pharmacokinetics, pharmacodynamics (saccadic peak velocity, adaptive tracking, body sway, visual analogue scales according to Bowdle and Bond and Lader, Karolinska Sleepiness Scale) and tolerability', 'mean elimination half-life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",,0.242715,"At 15 mg, saccadic peak velocity (degree/s; SD) was reduced (69; 38), while other variables showed no effects.","[{'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Muehlan', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Boehler', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Zuiker', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'van Gerven', 'Affiliation': 'Centre for Human Drug Research (CHDR), Leiden, The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119882854']
3061,31994641,Challenges and opportunities in the science of research to practice: lessons learned from a randomized controlled trial of a sexual risk-reduction intervention for psychiatric patients in a public mental health system.,"OBJECTIVE


Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers.
METHODS


The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions.
RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
CONCLUSION


Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step.
CLINICAL TRIAL REGISTRATION


NCT00881699.",2020,"RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
","['psychiatric patients', 'psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers', 'psychiatric patients in a public mental health system', 'Participants from eight clinics']","['HIV Prevention or Health Promotion conditions', 'sexual risk-reduction intervention']","['Information-Motivation-Behavioral domains', 'unprotected sex occasions']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}]",8.0,0.0553892,"RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
","[{'ForeName': 'Milton L', 'Initials': 'ML', 'LastName': 'Wainberg', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Claudio G', 'Initials': 'CG', 'LastName': 'Mann', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norcini-Pala', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKinnon', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Universidade Federal do Estado do Rio de Janeiro (UNIRIO), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Pinho', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Cavalcanti', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Leu', 'Initials': 'L', 'LastName': 'Cheng-Shiun', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Guimarães', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Palinkas', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Otto-Salaj', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Remien', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Cournos', 'Affiliation': 'Columbia University, New York, NY, USA.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0737']
3062,31787434,Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial.,"OBJECTIVES


To assess the use of epiaortic ultrasound in contemporary cardiac surgery, as well as its impact on surgical cannulation strategy and cerebrovascular events.
DESIGN


Epiaortic ultrasound data was prospectively collected in the Randomized Endovein Graft Prospective (REGROUP) trial (VA Cooperative Studies Program #588, ClinicalTrials.gov, NCT01850082), which randomized 1,150 coronary artery bypass graft patients between 2014 and 2017 to endoscopic or open-vein graft harvest.
SETTING


Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting.
PARTICIPANTS


Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment.
INTERVENTIONS


Epiaortic ultrasound was performed by the surgeon using a high frequency (>7 MHz) ultrasound transducer. Two-dimensional images of the ascending aorta in multiple planes were acquired before aortic cannulation and cross-clamping.
MEASUREMENTS AND MAIN RESULTS


Epiaortic ultrasound was performed in 34.1% (269 of 790) of patients in REGROUP. Among these patients, simple intraluminal atheroma was observed in 21.9% (59 269), and complex intraluminal atheroma comprised 2.2% (6 of 269). The aortic cannulation or cross-clamp strategy was modified based on these findings in 7.1% of cases (19 of 269). There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523).
CONCLUSIONS


Despite current guidelines recommending routine use of epiaortic ultrasound (IIa/B) to reduce the risk of stroke in cardiac surgery, in this contemporary trial, use remains infrequent, with significant site-to-site variability.",2020,"There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523).
","['Veterans Affairs patients, greater than 18 years of age, undergoing elective or urgent coronary artery bypass grafting with cardiopulmonary bypass and cardioplegic arrest with at least one planned saphenous vein graft were eligible for enrollment', 'Sixteen cardiac surgery programs within the Veterans Affairs Healthcare System with expertise at performing endoscopic vein-graft harvesting', '1,150 coronary artery bypass graft patients between 2014 and 2017 to']","['epiaortic ultrasound (IIa/B', 'endoscopic or open-vein graft harvest', 'epiaortic ultrasound']","['stroke', 'simple intraluminal atheroma']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft (substance)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0264956', 'cui_str': 'Atheromatous Plaques'}]",1150.0,0.0730764,"There was no difference in stroke between patients who underwent epiaortic ultrasound and those who did not (1.9% v 1.2% p = 0.523).
","[{'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Shapeton', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD. Electronic address: alexander.shapeton@va.gov.'}, {'ForeName': 'Kay B', 'Initials': 'KB', 'LastName': 'Leissner', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Suzana M', 'Initials': 'SM', 'LastName': 'Zorca', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Amirfarzan', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': 'Stock', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Office of Research and Development, Department of Veterans Affairs, Perry Point, MD.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Haime', 'Affiliation': 'Division of Cardiac Surgery, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Venkatesh', 'Initials': 'V', 'LastName': 'Srinivasa', 'Affiliation': 'Department of Anesthesia, Critical Care and Pain Medicine, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Quin', 'Affiliation': 'Division of Cardiac Surgery, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Zenati', 'Affiliation': 'Division of Cardiac Surgery, Veterans Affairs Boston Healthcare System and Harvard Medical School, Boston, MA.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.10.053']
3063,30342932,Body composition and dairy intake in sedentary employees who participated in a healthy program based on nutrition education and Zumba.,"BACKGROUND & AIMS


The dairy intake is associated with body composition; however, its effect is controversial and remains unknown in relation to exercise interventions as Zumba Fitness ® . Thus, we analyzed the body composition and its relation to dairy intake in sedentary employees who participated in a healthy program based on nutrition education and Zumba Fitness ® .
METHODS


Sixty-nine sedentary employees (age = 38.41 ± 7.45-yr, 81.16% women) participated in a healthy program (16-weeks) based on nutrition education (2 sessions, 1st and 10th week) and Zumba Fitness ®  (ZF) exercise programs [2 interventions: a) ZF, 1 h of ZF/3 day/week; b) ZF + BW, 1 h of ZF/3 day/week plus 20 min of bodyweight training]. Body composition (body weight, height, BMI, waist-hip index, ∑6-skinfolds, fat mass and muscle mass), blood pressure and dairy intake (milk, yogurt and cheese) were assessed at baseline and after interventions. Participants were categorized into normal weight (NW, BMI = 18.5-24.9 Kg/m 2 ) and excess weight (EW, BMI ≥ 25 Kg/m 2 ). Dairy intake and changes in BMI (ΔBMI = BMI after intervention-BMI at baseline) were divided into tertiles (T).
RESULTS


Only muscle mass (Kg) differed between ZF and ZF + BW (baseline and 16-weeks). Anthropometric indicators of adiposity were lower in NW than EW group (baseline). The ∑6-skinfolds and fat-mass decreased, while muscle mass increased in ZF and ZF + BW, and in NW and EW groups (16-weeks). The most consumed dairy was milk (baseline). Participants of T1 of cheese intake (baseline) had a higher reduction in BMI (0.42 ± 0.56 vs 0.62 ± 1.42 Kg/m 2 ) and in ∑6-skinfolds (40.23 ± 13.13 vs 23.51 ± 10.84 mm) than individuals in T3 (16-weeks). Employees who presented higher weight loss (T3, BMI decrease > 0.50 Kg/m 2 ) consumed lower cheese than the weight gain group (T1, BMI increase ≥ 0.33 Kg/m 2 ) (baseline).
CONCLUSIONS


Healthy programs based on nutrition education and Zumba Fitness ®  improve body composition both in EW and NW sedentary employees. ZF is as effective as ZF + BW. A lower cheese intake, at baseline, but not milk or yogurt, was related to a weight loss.",2019,"The ∑6-skinfolds and fat-mass decreased, while muscle mass increased in ZF and ZF + BW, and in NW and EW groups (16-weeks).","['sedentary employees who participated in a healthy program based on nutrition education and Zumba', 'Participants were categorized into normal weight (NW, BMI\xa0=\xa018.5-24.9\xa0Kg/m 2 ) and excess weight (EW', 'Sixty-nine sedentary employees (age\xa0=\xa038.41\xa0±\xa07.45-yr, 81.16% women) participated in a', 'sedentary employees who participated in a healthy program based on nutrition education and Zumba Fitness ® ']","['healthy program (16-weeks) based on nutrition education (2 sessions, 1st and 10th week) and Zumba Fitness ®  (ZF) exercise programs [2 interventions: a) ZF, 1\xa0h of ZF/3\xa0day/week; b) ZF\xa0+\xa0BW, 1\xa0h of ZF/3\xa0day/week plus 20\xa0min of bodyweight training', 'ZF']","['Body composition and dairy intake', 'BMI', 'weight loss', 'Dairy intake and changes in BMI (ΔBMI\xa0=\xa0BMI', 'Body composition (body weight, height, BMI, waist-hip index, ∑6-skinfolds, fat mass and muscle mass), blood pressure and dairy intake (milk, yogurt and cheese', 'BMI increase\xa0≥', 'Anthropometric indicators of adiposity']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}]",69.0,0.0393357,"The ∑6-skinfolds and fat-mass decreased, while muscle mass increased in ZF and ZF + BW, and in NW and EW groups (16-weeks).","[{'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Guerendiain', 'Affiliation': 'Metabolism and Nutrition Disorders Research Group, School of Medicine, Faculty of Health Sciences, National University of Chimborazo, Riobamba, Ecuador. Electronic address: mguerendiain@unach.edu.ec.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Department of Physical Education and Sport, University of Granada, Granada, Spain; Physical Activity, Sport and Health Group, School of Physical Culture, Faculty of Health Sciences, National University of Chimborazo, Riobamba, Ecuador.'}, {'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'PROFITH ""PROmoting FITness and Health through Physical Activity"" Research Group, Department of Physical Education and Sport, University of Granada, Granada, Spain; Physical Activity, Sport and Health Group, School of Physical Culture, Faculty of Health Sciences, National University of Chimborazo, Riobamba, Ecuador.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.09.032']
3064,31883933,"Efficacy and Safety of Ultrasound-Guided Supraclavicular Brachial Plexus Block during Angioplasty of Dysfunctional Arteriovenous Access: A Prospective, Randomized Single-Center Clinical Trial.","PURPOSE


To evaluate the efficacy and safety of the ultrasound-guided supraclavicular brachial plexus block (BPB) during angioplasty of dysfunctional arteriovenous access.
MATERIALS AND METHODS


Eighty study participants with dysfunctional arteriovenous access were enrolled in this prospective, randomized clinical trial between November 2016 and February 2018. Eighty patients were randomized to either the ultrasound-guided supraclavicular BPB group (mean age ± standard deviation [SD], 65.1 ± 12.4; male:female = 17:23) or the no regional anesthesia group (mean age ± SD, 64.0 ± 11.7; male:female = 25:15). Pain was assessed on the 10-point Visual Analogue Scale. Participant satisfaction was examined. Six-month clinical follow-up was done to evaluate arteriovenous access patency and long-term complications.
RESULTS


The BPB group showed a lower average pain score than the control group (mean ± SD, 0.9 ± 1.9 vs 6.4 ± 2.5; P < .001). Participant satisfaction (mean ± SD, 2.8 ± 0.5 vs 2.1±0.8; P < .001) was also higher in the BPB group. Six-month patency was 65% (26/40) in the BPB group and 59% (23/39) in the control group, with no significant difference between the 2 groups (P = .59). No major immediate or delayed complications were observed.
CONCLUSIONS


Ultrasound-guided BPB is highly effective in reducing pain during angioplasty of dysfunctional arteriovenous access with an acceptable safety profile.",2020,"No major immediate or delayed complications were observed.
","['Dysfunctional Arteriovenous Access', 'Eighty study participants with dysfunctional arteriovenous access', 'group (mean age ± standard deviation [SD], 65.1 ± 12.4; male:female\xa0= 17:23) or the no regional anesthesia group (mean age ± SD, 64.0 ± 11.7; male:female\xa0= 25:15', 'Eighty patients']","['ultrasound-guided supraclavicular brachial plexus block (BPB', 'ultrasound-guided supraclavicular BPB', 'Ultrasound-guided BPB', 'Ultrasound-Guided Supraclavicular Brachial Plexus Block']","['Six-month patency', 'delayed complications', 'average pain score', 'efficacy and safety', 'Pain', '10-point Visual Analogue Scale', 'pain', 'Efficacy and Safety']","[{'cui': 'C0450109', 'cui_str': 'Arteriovenous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517543', 'cui_str': '12.4 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C4517535', 'cui_str': '11.7 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0394699', 'cui_str': 'Brachial plexus block by supraclavicular approach (procedure)'}, {'cui': 'C1608675', 'cui_str': '4-iodo-N-(4-(4-(2-methoxyphenyl)-piperazin-1-yl)butyl)-benzamide'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}]","[{'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",80.0,0.0849338,"No major immediate or delayed complications were observed.
","[{'ForeName': 'Subin', 'Initials': 'S', 'LastName': 'Heo', 'Affiliation': 'Department of Radiology, Ajou University School of Medicine, 206 Worldcup-ro, Yeongtong-gu, 443-749, Suwon, Korea.'}, {'ForeName': 'Je Hwan', 'Initials': 'JH', 'LastName': 'Won', 'Affiliation': 'Department of Radiology, Ajou University School of Medicine, 206 Worldcup-ro, Yeongtong-gu, 443-749, Suwon, Korea. Electronic address: wonkwak@ajou.ac.kr.'}, {'ForeName': 'Jinoo', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Ajou University School of Medicine, 206 Worldcup-ro, Yeongtong-gu, 443-749, Suwon, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 206 Worldcup-ro, Yeongtong-gu, 443-749, Suwon, Korea.'}, {'ForeName': 'Han Bum', 'Initials': 'HB', 'LastName': 'Joe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 206 Worldcup-ro, Yeongtong-gu, 443-749, Suwon, Korea.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.11.002']
3065,31881421,Effects of biophilic indoor environment on stress and anxiety recovery: A between-subjects experiment in virtual reality.,"Previous research has demonstrated the positive associations between outdoor nature contact and stress reduction. However, similar effects of incorporating natural elements into indoor environment (i.e. biophilic design) have been less well studied. We hypothesize that exposure to biophilic indoor environments help people recover from stress and anxiety and those effects differ among different types of biophilic elements. To test these hypotheses, we conducted a between-subjects experiment with 100 participants using virtual reality (VR). Participants were randomly assigned to experience one of four virtual offices (i.e. one non-biophilic base office and three similar offices enhanced with different biophilic design elements) after stressor tasks. Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors. Their anxiety level was measured by using State-Trait Anxiety Inventory test (short version). We found that participants in biophilic indoor environments had consistently better recovery responses after stressor compare to those in the non-biophilic environment, in terms of reduction on stress and anxiety. Effects on physiological responses are immediate after exposure to biophilic environments with the larger impacts in the first four minutes of the 6-minute recovery process. Additionally, these restorative effects differ among three different types of indoor biophilic environments. This research provides evidence that biophilic design elements that impact stress recovery and anxiety. It also demonstrated the potential that virtual reality may be a way to bring nature and its therapeutic benefits to patients in hospitals.",2020,"Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors.","['subjects experiment in virtual reality', '100 participants using virtual reality (VR']",['biophilic indoor environment'],"['anxiety level', 'stress and anxiety recovery', 'State-Trait Anxiety Inventory test (short version', 'heart rate variability, heart rate, skin conductance level and blood pressure', 'stress and anxiety', 'recovery responses']","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",100.0,0.0219307,"Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Population Health Sciences Program, Harvard Graduate School of Arts and Sciences, Cambridge, MA, USA. Electronic address: jieyin@hsph.harvard.edu.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Arfaei', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Catalano', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Allen', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Spengler', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Environment international,['10.1016/j.envint.2019.105427']
3066,31356450,A randomized controlled efficacy trial of mindfulness-based stress reduction compared with an active control group and usual care for fibromyalgia: the EUDAIMON study.,"Fibromyalgia (FM) syndrome represents a great challenge for clinicians and researchers because the efficacy of currently available treatments is limited. This study examined the efficacy of mindfulness-based stress reduction (MBSR) for reducing functional impairment as well as the role of mindfulness-related constructs as mediators of treatment outcomes for people with FM. Two hundred twenty-five participants with FM were randomized into 3 study arms: MBSR plus treatment-as-usual (TAU), FibroQoL (multicomponent intervention for FM) plus TAU, and TAU alone. The primary endpoint was functional impact (measured with the Fibromyalgia Impact Questionnaire Revised), and secondary outcomes included ""fibromyalginess,"" anxiety and depression, pain catastrophising, perceived stress, and cognitive dysfunction. The differences in outcomes between groups at post-treatment assessment (primary endpoint) and 12-month follow-up were analyzed using linear mixed-effects models and mediational models through path analyses. Mindfulness-based stress reduction was superior to TAU both at post-treatment (large effect sizes) and at follow-up (medium to large effect sizes), and MBSR was also superior to FibroQoL post-treatment (medium to large effect sizes), but in the long term, it was only modestly better (significant differences only in pain catastrophising and fibromyalginess). Immediately post-treatment, the number needed to treat for 20% improvement in MBSR vs TAU and FibroQoL was 4.0 (95% confidence interval [CI] = 2.1-6.5) and 5.0 (95% CI = 2.7-37.3). An unreliable number needed to treat value of 9 (not computable 95% CI) was found for FibroQoL vs TAU. Changes produced by MBSR in functional impact were mediated by psychological inflexibility and the mindfulness facet acting with awareness. These findings are discussed in relation to previous studies of psychological treatments for FM.",2019,"Mindfulness-based stress reduction was superior to TAU both at post-treatment (large effect sizes) and at follow-up (medium to large effect sizes), and MBSR was also superior to FibroQoL post-treatment (medium to large effect sizes), but in the long term, it was only modestly better (significant differences only in pain catastrophising and fibromyalginess).","['for fibromyalgia', 'Two hundred twenty-five participants with FM', 'people with FM']","['mindfulness-based stress reduction (MBSR', 'MBSR plus treatment-as-usual (TAU), FibroQoL (multicomponent intervention for FM) plus TAU, and TAU alone', 'mindfulness-based stress reduction compared with an active control group and usual care']","['number needed to treat for 20% improvement in MBSR vs TAU and FibroQoL', 'pain catastrophising and fibromyalginess', 'functional impact (measured with the Fibromyalgia Impact Questionnaire Revised), and secondary outcomes included ""fibromyalginess,"" anxiety and depression, pain catastrophising, perceived stress, and cognitive dysfunction', 'MBSR']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",225.0,0.0754491,"Mindfulness-based stress reduction was superior to TAU both at post-treatment (large effect sizes) and at follow-up (medium to large effect sizes), and MBSR was also superior to FibroQoL post-treatment (medium to large effect sizes), but in the long term, it was only modestly better (significant differences only in pain catastrophising and fibromyalginess).","[{'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Pérez-Aranda', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Montero-Marín', 'Affiliation': 'Dharamsala Institute of Mindfulness and Psychotherapy, Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Primary Care Prevention and Health Promotion Research Network, RedIAPP, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andrés-Rodríguez', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Borràs', 'Affiliation': 'Basic Psychology Unit, Autonomous University of Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rozadilla-Sacanell', 'Affiliation': 'Rheumatology Service, Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Spain.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Peñarrubia-Maria', 'Affiliation': 'Primary Health Centre Bartomeu Fabrés Anglada, SAP Delta Llobregat, Unitat Docent Costa de Ponent, Institut Català de la Salut, Gavà, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Angarita-Osorio', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'McCracken', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Group of Psychological Research in Fibromyalgia and Chronic Pain (AGORA), Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}]",Pain,['10.1097/j.pain.0000000000001655']
3067,31356456,"Repetitive transcranial magnetic stimulation of the primary motor cortex expedites recovery in the transition from acute to sustained experimental pain: a randomised, controlled study.","Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex (M1) is increasingly being investigated as a means of alleviating chronic pain. However, rTMS interventions are typically initiated once pain has already become chronic and maladaptive patterns of neural activity are likely to have been established. A critical question is whether M1 rTMS applied soon after pain onset can prevent the development of maladaptive neural activity and promote recovery. This study investigated the effect of 5 consecutive days of excitatory M1 rTMS on pain, functional limitation, mechanical hyperalgesia, descending inhibitory pain control, and M1 organisation in the transition from acute to sustained pain. Thirty healthy participants attended 8 sessions over a 16-day period. On days 0, 2, and 4, nerve growth factor was injected into the right forearm to induce progressively developing muscle soreness and mechanical hyperalgesia. Active or sham excitatory rTMS was delivered on days 4 to 8. Clinical and neurophysiological outcomes were recorded on days 0, 2, 4, 6, 8, 11, and 14. Active rTMS promoted recovery of muscle soreness, pain, and mechanical hyperalgesia when compared with sham rTMS (all between-group P < 0.05). Corticomotor excitability and descending inhibitory pain control did not differ between groups. These findings suggest that active excitatory M1 rTMS promotes recovery of muscle soreness, pain, and mechanical hyperalgesia in the transition from acute to sustained experimental pain. The analgesic effects of M1 rTMS do not seem to be modulated by descending inhibitory pain control or local changes in corticomotor excitability.",2019,"Active rTMS promoted recovery of muscle soreness, pain, and mechanical hyperalgesia when compared with sham rTMS (all between-group P < 0.05).","['acute to sustained experimental pain', 'Thirty healthy participants attended 8 sessions over a 16-day period']","['Repetitive transcranial magnetic stimulation (rTMS', 'active excitatory M1 rTMS', 'excitatory M1 rTMS', 'Active or sham excitatory rTMS', 'Repetitive transcranial magnetic stimulation']","['muscle soreness, pain, and mechanical hyperalgesia', 'Clinical and neurophysiological outcomes', 'pain, functional limitation, mechanical hyperalgesia, descending inhibitory pain control, and M1 organisation', 'recovery of muscle soreness, pain, and mechanical hyperalgesia', 'Corticomotor excitability and descending inhibitory pain control']","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2936719', 'cui_str': 'Mechanical Allodynia'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",30.0,0.154346,"Active rTMS promoted recovery of muscle soreness, pain, and mechanical hyperalgesia when compared with sham rTMS (all between-group P < 0.05).","[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Cavaleri', 'Affiliation': 'School of Science and Health, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lucy S', 'Initials': 'LS', 'LastName': 'Chipchase', 'Affiliation': 'School of Science and Health, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Summers', 'Affiliation': 'School of Science and Health, Western Sydney University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Siobhan M', 'Initials': 'SM', 'LastName': 'Schabrun', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}]",Pain,['10.1097/j.pain.0000000000001656']
3068,31972599,Advances in the treatment of biliary tract cancers.,"PURPOSE OF REVIEW


To review new treatment and advances in biliary tract cancer (BTC).
RECENT FINDINGS


In the prespecified per-protocol analysis of the randomized phase III trial BILCAP, adjuvant capecitabine offers overall survival (OS) benefit when compared with observation with statistical significance. In the first-line setting in metastatic BTC, gemcitabine and S-1 had noninferior OS compared with gemcitabine and cisplatin. In a separate phase III study, the triplet of gemcitabine, cisplatin and S-1 (GCS) had superior OS compared with standard gemcitabine and cisplatin. The regimen of modified FOLFOX (fluorouracil, leucovorin and oxaliplatin) regimen can be considered a potential standard option in the second-line setting for patients who failed first-line therapy with gemcitabine-based regimens. Trials in genomically selected patients indicate activity of fibroblast growth factor receptor inhibitors, mutant isocitrate dehydrogenase inhibitors and immune checkpoint inhibitors.
SUMMARY


Capecitabine is a new option for adjuvant treatment in resected BTC. In the metastatic setting, gemcitabine and S-1 or GCS are new options for first-line therapy and modified FOLFOX regimen should be considered as a potential new empirical standard of care in genomically agnostic patients requiring second-line therapy. Future randomized trials will evaluate the role of targeted agents and immunotherapy in advanced BTC, both in monotherapy and in combination.",2020,"In the first-line setting in metastatic BTC, gemcitabine and S-1 had noninferior OS compared with gemcitabine and cisplatin.","['biliary tract cancer (BTC', 'biliary tract cancers', 'genomically agnostic patients requiring second-line therapy', 'patients who failed first-line therapy with gemcitabine-based regimens']","['gemcitabine, cisplatin and S-1 (GCS', 'gemcitabine', 'gemcitabine and cisplatin', 'standard gemcitabine and cisplatin', 'modified FOLFOX (fluorouracil, leucovorin and oxaliplatin', 'gemcitabine and S-1 or GCS', 'Capecitabine', 'BILCAP, adjuvant capecitabine']",['overall survival (OS) benefit'],"[{'cui': 'C0750952', 'cui_str': 'Biliary Tract Cancer'}, {'cui': 'C0344347', 'cui_str': 'Agnostic (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0180825,"In the first-line setting in metastatic BTC, gemcitabine and S-1 had noninferior OS compared with gemcitabine and cisplatin.","[{'ForeName': 'Pedro L S', 'Initials': 'PLS', 'LastName': 'Uson Junior', 'Affiliation': 'Mayo Clinic Cancer Center, Division of Hematology/Oncology, Mayo Clinic, Phoenix, Arizona, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bogenberger', 'Affiliation': 'Mayo Clinic Cancer Center, Division of Hematology/Oncology, Mayo Clinic, Phoenix, Arizona, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Mayo Clinic Cancer Center, Division of Hematology/Oncology, Mayo Clinic, Phoenix, Arizona, USA.'}]",Current opinion in gastroenterology,['10.1097/MOG.0000000000000606']
3069,32005604,Effect of the ASPAN Guideline on Perioperative Hypothermia Among Patients With Upper Extremity Surgery Under General Anesthesia: A Randomized Controlled Trial.,"PURPOSE


To evaluate the effect of using the evidence-based hypothermia guideline developed by the American Society of PeriAnesthesia Nurses on body temperature, shivering, thermal discomfort and comfort, and incidence of hypothermia.
DESIGN


Randomized controlled trial with 54 patients undergoing upper arm surgery with general anesthesia in the Republic of Korea.
METHODS


Participants in the experimental group received a head turban, sleeping socks, a heated blanket, a Bair Hugger for forced-air warming, and a Mega Acer kit (ACE Medical Co, Seoul, Korea) for warming intravenous fluid. Participants in the control group received a typical hospital cotton blanket.
FINDINGS


Body temperature, shivering, thermal discomfort, and thermal comfort showed significant improvements in the experimental group compared with the control group.
CONCLUSIONS


The American Society of PeriAnesthesia Nurses guideline is applicable for preventing hypothermia under general anesthesia, which, in turn, aids in patient recovery through the suppression of various hypothermia-related complications.",2020,"FINDINGS


Body temperature, shivering, thermal discomfort, and thermal comfort showed significant improvements in the experimental group compared with the control group.
","['54 patients undergoing upper arm surgery with general anesthesia in the Republic of Korea', 'Patients With Upper Extremity Surgery Under General Anesthesia', 'Participants in the experimental group received a']","['head turban, sleeping socks, a heated blanket, a Bair Hugger for forced-air warming, and a Mega Acer kit (ACE Medical Co, Seoul, Korea) for warming intravenous fluid', 'typical hospital cotton blanket', 'ASPAN Guideline']","['Body temperature, shivering, thermal discomfort, and thermal comfort', 'Perioperative Hypothermia', 'body temperature, shivering, thermal discomfort and comfort, and incidence of hypothermia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0453970', 'cui_str': 'Turban (physical object)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0445269', 'cui_str': 'Socks (physical object)'}, {'cui': 'C0179330', 'cui_str': 'Blanket, device (physical object)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0330996', 'cui_str': 'Maple'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1095832', 'cui_str': 'Cotton - textile'}, {'cui': 'C0655772', 'cui_str': 'aspan'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",54.0,0.0647667,"FINDINGS


Body temperature, shivering, thermal discomfort, and thermal comfort showed significant improvements in the experimental group compared with the control group.
","[{'ForeName': 'Sookyung', 'Initials': 'S', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Nowon Eulji Medical Center, Eulji University, Nowon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Soohyun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Nursing, Eulji University (Seongnam), Gyeonggi-do, Republic of Korea. Electronic address: soohyunp@eulji.ac.kr.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.11.004']
3070,31995024,Short-Term Effect of Hypergastrinemia Following Esomeprazole Treatment On Well-Controlled Type 2 Diabetes Mellitus: A Prospective Study.,"OBJECTIVE


Proton pump inhibitor (PPI) drugs reduce gastric acid secretion and lead to an increase in serum gastrin levels. Many preclinical and some clinical researches have established some positive effects of gastrin or PPI therapy on glucose regulation. The aim of this study was to prospectively investigate the short term effects of esomeprazole on glycaemic control in patients with type 2 diabetes mellitus. In addition, the presence of an association between this effect and gastrin levels was evaluated.
METHODS


Thirty-two subjects with type 2 diabetes mellitus were enrolled and grouped as intervention (n=16) and control (n=16). The participants in the intervention group were prescribed 40 mg of esomeprazole treatment for three months. At the beginning of the study and at the 3rd month, HbA1c level (%) and gastrin levels (pmol/L) of participants were assessed. Then, the groups were compared in terms of their baseline and 3rd month values.
RESULTS


In the intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001). The mean HbA1c level was similar to the pre-treatment level (6.3±0.7% vs. 6.4±0.9%, p=0.441). There were no statistically significant differences in all parameters of the control group. The majority of individuals were on metformin monotherapy (65.6 %). The subgroup analysis of metformin monotherapy revealed that, in intervention group, there was a significant increase in gastrin levels (39.9±12.6 vs. 95.5±52.5, p=0.026), but the HbA1c levels did not change (6.0±0.4 % vs. 5.9±0.6 %, p=0.288); and in control group, gastrin levels did not change (37.5 ± 26.7 vs. 36.1 ±23.3, p=0.367), but there was an increase in HbA1c levels (6.1 ± 0.50 vs. 6.4 ± 0.60, p=0.01).
CONCLUSION


Our study demonstrates that esomeprazole has no extra benefit for the controlled diabetic patient in three months. However, in only the metformin-treated subgroup, esomeprazole may prevent the rise in HbA1c level.",2020,"In intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001).","['Thirty-two subjects with type 2 diabetes mellitus were enrolled and grouped as intervention (n=16) and control (n=16', 'patients with type 2 diabetes mellitus', 'Type 2 Diabetes Mellitus']","['gastrin or PPI therapy', 'esomeprazole', 'Esomeprazole Treatment', 'metformin monotherapy']","['serum gastrin levels', 'HbA1c level (%) and gastrin levels', 'mean HbA1c level', 'mean gastrin level', 'HbA1c levels', 'gastrin levels', 'rise in HbA1c level']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0376180', 'cui_str': 'Gastrin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0428386', 'cui_str': 'Serum gastrin measurement'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202036', 'cui_str': 'Gastrin measurement (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",32.0,0.0338128,"In intervention group, the mean gastrin level increased significantly from 34.3±14.4 pmol/L to 87.4±43.6 pmol/L (p<0.001).","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Bozkuş', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Mousa', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Özlem T', 'Initials': 'ÖT', 'LastName': 'İyidir', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Nazlı', 'Initials': 'N', 'LastName': 'Kırnap', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Canan Ç', 'Initials': 'CÇ', 'LastName': 'Demir', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Nar', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}, {'ForeName': 'Neslihan B', 'Initials': 'NB', 'LastName': 'Tütüncü', 'Affiliation': 'Department of Endocrinology and Metabolism, Faculty of Medicine, Baskent University, Ankara, Turkey.'}]","Endocrine, metabolic & immune disorders drug targets",['10.2174/1871530320666200129124555']
3071,31558398,Sustained High-dose Thiamine Supplementation in High-risk Cardiac Patients Undergoing Cardiopulmonary Bypass: A Pilot Feasibility Study (The APPLY trial).,"OBJECTIVE


To test the feasibility and investigate possible cardiovascular effects of a sustained high-dose intravenous thiamine protocol in patients undergoing combined valvular and coronary artery bypass graft surgery.
DESIGN


Randomized, placebo-controlled, pilot feasibility trial.
SETTING


Cardiac surgery department of a tertiary hospital.
PARTICIPANTS


Forty patients undergoing combined valvular and coronary artery bypass surgery.
INTERVENTIONS


Intravenous thiamine (600 mg on the day of surgery, and 400 mg/day on postoperative days 1, 2, and 3) or placebo.
MEASUREMENTS AND MAIN RESULTS


The primary feasibility endpoints were recruitment rate and protocol compliance. Secondary endpoints included markers of possible biological and physiological effects. The mean recruitment rate was 8 patients per month and protocol compliance was 97.5%. There were no differences in median peak postoperative lactate (2.7 mmol/L [interquartile range [IQR] 1.4-4.6] for thiamine v 2.5 mmol/L [IQR 1.4-3.6] for placebo; p = 0.53), median peak postoperative creatinine (104 µmol/L [IQR 92.5-129] for thiamine v 99 µmol/L [IQR 86.5-109.5] for placebo; p = 0.53), median nadir postoperative cardiac index (1.8 L/min/m 2  [IQR 1.5-2.1] for thiamine v 2.2 L/min/m 2  [IQR 1.5-2.5] for placebo; p = 0.25), or the number of patients on vasopressor/inotropic agents (thiamine, 12 [63%]; placebo, 12 [60%]; p = 0.80), or in the total inotrope/vasopressor dose 0.14 µg/kg for thiamine v 0.12 µg/kg for placebo; p = 0.88).
CONCLUSIONS


A double-blind trial of sustained high-dose intravenous thiamine supplementation in higher-risk cardiac surgery patients was feasible and appeared to be safe. However, such treatment did not demonstrate evidence of biological or physiological effects.",2020,"There were no differences in median peak postoperative lactate (2.7 mmol/L [interquartile range [IQR] 1.4-4.6] for thiamine v 2.5 mmol/L [IQR 1.4-3.6] for placebo; p = 0.53), median peak postoperative creatinine (104 µmol/L [IQR 92.5-129] for thiamine v 99 µmol/L [IQR 86.5-109.5] for placebo; p = 0.53), median nadir postoperative cardiac index (1.8 L/min/m 2  [IQR 1.5-2.1] for thiamine v 2.2 L/min/m 2  [IQR 1.5-2.5] for placebo; p = 0.25), or the number of patients on vasopressor/inotropic agents (thiamine, 12 [63%]; placebo, 12 [60%]; p = 0.80), or in the total inotrope/vasopressor dose 0.14 µg/kg for thiamine v 0.12 µg/kg for placebo; p = 0.88).
","['High-risk Cardiac Patients Undergoing Cardiopulmonary Bypass', 'higher-risk cardiac surgery patients', 'Cardiac surgery department of a tertiary hospital', 'Forty patients undergoing combined valvular and coronary artery bypass surgery', 'patients undergoing combined valvular and coronary artery bypass graft surgery']","['Intravenous thiamine', 'sustained high-dose intravenous thiamine protocol', 'sustained high-dose intravenous thiamine supplementation', 'placebo', 'Sustained High-dose Thiamine Supplementation']","['median peak postoperative creatinine', 'median peak postoperative lactate', 'markers of possible biological and physiological effects', 'median nadir postoperative cardiac index', 'recruitment rate and protocol compliance', 'mean recruitment rate']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0587507', 'cui_str': 'Cardiac surgery department (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4524016', 'cui_str': 'Vitamin B1 supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0525058', 'cui_str': 'Protocol Compliance'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",40.0,0.761128,"There were no differences in median peak postoperative lactate (2.7 mmol/L [interquartile range [IQR] 1.4-4.6] for thiamine v 2.5 mmol/L [IQR 1.4-3.6] for placebo; p = 0.53), median peak postoperative creatinine (104 µmol/L [IQR 92.5-129] for thiamine v 99 µmol/L [IQR 86.5-109.5] for placebo; p = 0.53), median nadir postoperative cardiac index (1.8 L/min/m 2  [IQR 1.5-2.1] for thiamine v 2.2 L/min/m 2  [IQR 1.5-2.5] for placebo; p = 0.25), or the number of patients on vasopressor/inotropic agents (thiamine, 12 [63%]; placebo, 12 [60%]; p = 0.80), or in the total inotrope/vasopressor dose 0.14 µg/kg for thiamine v 0.12 µg/kg for placebo; p = 0.88).
","[{'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia. Electronic address: vvlom@mail.ru.'}, {'ForeName': 'Gleb', 'Initials': 'G', 'LastName': 'Moroz', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Samandar', 'Initials': 'S', 'LastName': 'Ismoilov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Shmyrev', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Efremov', 'Affiliation': 'Saint Petersburg State University Hospital, Saint Petersburg, Russia.'}, {'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Abubakirov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Vasily', 'Initials': 'V', 'LastName': 'Batalov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Bogachev-Prokophiev', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Sapegin', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, The University of Melbourne, Melbourne, Australia.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2019.08.044']
3072,32114502,"Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer.","BACKGROUND


The immunosuppressive desmoplastic stroma of pancreatic cancer represents a major hurdle to developing an effective immune response. Preclinical studies in pancreatic cancer have demonstrated promising anti-tumor activity with Bruton tyrosine kinase (BTK) inhibition combined with programmed cell death receptor-1 (PD-1) blockade.
METHODS


This was a phase II, multicenter, open-label, randomized (1:1) clinical trial evaluating the BTK inhibitor acalabrutinib, alone (monotherapy) or in combination with the anti-PD-1 antibody pembrolizumab (combination therapy). Eligible patients were adults with histologically confirmed metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1 who had received at least one prior systemic therapy. Oral acalabrutinib 100 mg twice daily was administered with or without intravenous pembrolizumab 200 mg on day 1 of each 3-week cycle. Peripheral blood was analyzed for changes in immune markers, and tumors from exceptional responders were molecularly analyzed.
RESULTS


A total of 77 patients were enrolled (37 monotherapy; 40 combination therapy) with a median age of 64 years; 77% had an ECOG PS of 1. The median number of prior therapies was 3 (range 1-6). Grade 3-4 treatment-related adverse events were seen in 14.3% of patients in the monotherapy arm and 15.8% of those in the combination therapy arm. The overall response rate and disease control rate were 0% and 14.3% with monotherapy and 7.9% and 21.1% with combination therapy, respectively. Median progression-free survival was 1.4 months in both arms. Peripheral blood flow analysis demonstrated consistent reductions in granulocytic (CD15+) myeloid-derived suppressor cells (MDSCs) over time. Two exceptional responders were found to be microsatellite stable with low tumor mutation burden, low neoantigen load and no defects in the homologous DNA repair pathway.
CONCLUSIONS


The combination of acalabrutinib and pembrolizumab was well tolerated, but limited clinical activity was seen with either acalabrutinib monotherapy or combination therapy. Peripheral reductions in MDSCs were seen. Efforts to understand and target the pancreatic tumor microenvironment should continue.
TRIAL REGISTRATION NUMBER


NCT02362048.",2020,"The combination of acalabrutinib and pembrolizumab was well tolerated, but limited clinical activity was seen with either acalabrutinib monotherapy or combination therapy.","['Eligible patients were adults with histologically confirmed metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤1\u2009who had received at least one prior systemic therapy', 'patients with advanced pancreatic cancer', '77 patients were enrolled (37 monotherapy; 40 combination therapy) with a median age of 64 years; 77% had an ECOG PS of 1']","['BTK inhibitor acalabrutinib, alone (monotherapy) or in combination with the anti-PD-1 antibody pembrolizumab (combination therapy', 'Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab', 'Oral acalabrutinib 100\u2009mg twice daily was administered with or without intravenous pembrolizumab', 'acalabrutinib and pembrolizumab']","['overall response rate and disease control rate', 'Peripheral blood', 'adverse events', 'median number of prior therapies', 'Peripheral reductions in MDSCs', 'granulocytic (CD15+) myeloid-derived suppressor cells (MDSCs', 'Median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4521488', 'cui_str': 'Non-specific protein-tyrosine kinase inhibitor'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4530084', 'cui_str': 'acalabrutinib 100 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4277543', 'cui_str': 'Myeloid-Derived Suppressor Cells'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",77.0,0.0590349,"The combination of acalabrutinib and pembrolizumab was well tolerated, but limited clinical activity was seen with either acalabrutinib monotherapy or combination therapy.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Overman', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA moverman@mdanderson.org.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Davis', 'Affiliation': 'Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Vats', 'Affiliation': 'Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Kumar-Sinha', 'Affiliation': 'Michigan Center for Translational Pathology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Niharika B', 'Initials': 'NB', 'LastName': 'Mettu', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, Duke Cancer Institute, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Edwin R', 'Initials': 'ER', 'LastName': 'Parra', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Department of Medicine, Hematology Oncology Division, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Lopez', 'Affiliation': 'Department of Oncology, School of Medicine, Oregon Health and Science University Foundation, Portland, Oregon, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Acerta Pharma LLC, Redwood City, California, USA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma LLC, Redwood City, California, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Acerta Pharma LLC, Redwood City, California, USA.'}, {'ForeName': 'Sattva', 'Initials': 'S', 'LastName': 'Neelapu', 'Affiliation': 'Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anirban', 'Initials': 'A', 'LastName': 'Maitra', 'Affiliation': 'Department of Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000587']
3073,32179871,Gut microbiota in neonates with congenital gastrointestinal surgical conditions: a prospective study.,"BACKGROUND


There is limited information on gut microbiota of neonates with congenital gastrointestinal surgical conditions (CGISCs) available.
METHODS


This study compared stool microbiota and short-chain fatty acids (SCFAs) of 37 term infants with CGISCs with 36 term healthy infants (HIs). Two stool samples were collected from each infant: as soon as possible after birth (week 1) and 10-14 days of life (week 2).
RESULTS


Bacterial richness and alpha diversity were comparable between CGISCs and HIs at week 1 and week 2 (all p > 0.05). Beta diversity analysis revealed that at week 1, CGISCs had similar community structures to HIs (p = 0.415). However, by week 2, community structures of CGISCs were significantly different from HIs (p = 0.003). At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs. At week 2, the relative abundance of Bifidobacterium was significantly lower in CGISCs (mean percentage 7.21 ± 13.49 vs. 28.96 ± 19.6; p = 0.002). Bacteroides were also less abundant in the CGISC group (mean percentage 0.12 ± 0.49 vs. 6.59 ± 8.62; p = 0.039). Relative abundance of genera Pseudomonas and Escherichia-Shigella were higher in CGISCs. At week 2, stool concentrations of all SCFAs were lower in CGISCs (all p < 0.001).
CONCLUSIONS


During hospitalization, neonates with CGISCs develop gut dysbiosis and deficiency of SCFAs.
IMPACT


During hospitalisation, neonates with congenital gastrointestinal surgical conditions develop gut dysbiosis with deficiency of Bifidobacteria and Bacteroides and increased abundance of Escherichia-Shigella and Pseudomonas. They also have low levels of short chain fatty acids in their stools compared to healthy infants.This is the first study evaluating the gut microbiota using 16S ribosomal RNA sequencing methods and stool short chain fatty acids in neonates with congenital gastrointestinal surgical conditions and comparing them to healthy infants.The findings of this study will pave the way for randomised trials of bifidobacterial supplementation in neonates with congenital gastrointestinal surgical conditions.",2020,"At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs.","['neonates with congenital gastrointestinal surgical conditions and comparing them to healthy infants', 'neonates with congenital gastrointestinal surgical conditions (CGISCs) available', '37 term infants with CGISCs with 36 term healthy infants (HIs', 'neonates with congenital gastrointestinal surgical conditions']","['bifidobacterial supplementation', '16S ribosomal RNA sequencing methods and stool short chain fatty acids', 'stool microbiota and short-chain fatty acids (SCFAs']","['relative abundances of genera Bifidobacterium and Bacteroides', 'Relative abundance of genera Pseudomonas and Escherichia-Shigella', 'community structures of CGISCs', 'stool concentrations of all SCFAs', 'Bacteroides', 'Bacterial richness and alpha diversity', 'relative abundance of Bifidobacterium', 'Gut microbiota']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C0014833', 'cui_str': 'Escherichia'}, {'cui': 'C0036953', 'cui_str': 'Shigella'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",37.0,0.0788522,"At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs.","[{'ForeName': 'Shripada C', 'Initials': 'SC', 'LastName': 'Rao', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia. shripada.rao@health.wa.gov.au.""}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Esvaran', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Patole', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia.""}, {'ForeName': 'Karen N', 'Initials': 'KN', 'LastName': 'Simmer', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gollow', 'Affiliation': ""Department of Paediatric Surgery, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keil', 'Affiliation': 'PathWest Laboratory Medicine, Perth, WA, Australia.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wemheuer', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Conway', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}]",Pediatric research,['10.1038/s41390-020-0824-7']
3074,32154887,Association of Baseline Inflammation With Effectiveness of Nutritional Support Among Patients With Disease-Related Malnutrition: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Inflammation is a key driver of malnutrition during illness and is often accompanied by metabolic effects, including insulin resistance and reduction of appetite. However, it still remains unclear if inflammation influences the response to nutritional support among patients with disease-related malnutrition.
Objective


To examine whether patients' baseline inflammatory status is associated with the effect of nutritional support on 30-day mortality.
Design, Setting, and Participants


This is a secondary analysis of the Effect of Early Nutritional Support on Frailty, Functional Outcomes, and Recovery of Malnourished Medical Inpatients Trial (EFFORT), a randomized clinical trial conducted in 8 Swiss hospitals from April 2014 to February 2018. A total of 1950 participants who had C-reactive protein measurements at the time of admission were included in this secondary analysis. Data analysis was conducted between June and July 2019.
Interventions


Hospitalized patients at risk for malnutrition were randomly assigned to receive protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group).
Main Outcomes and Measures


The primary end point was 30-day mortality. Based on C-reactive protein levels at admission, patients were stratified into groups with low, moderate, or high inflammation (<10 mg/L, 10-100 mg/L, and >100 mg/L, respectively).
Results


A total of 1950 patients (median [interquartile range] age, 75 [65-83] years; 1025 [52.6%] men) were included; 533 (27.3%) had low levels of inflammation, 894 (45.9%) had moderate levels of inflammation, and 523 (26.8%) had high levels of inflammation. Compared with the control group, patients receiving nutritional support showed a significant reduction in 30-day mortality, regardless of C-reactive protein level (adjusted odds ratio, 0.61; 95% CI, 0.43-0.86; P = .005). In the subgroup of patients with high inflammation, there was no beneficial effect of nutritional support (adjusted odds ratio, 1.32; 95% CI, 0.70-2.50; P = .39), providing evidence that inflammation has a significant modifying association (P for interaction = .005).
Conclusions and Relevance


Based on this secondary analysis of a multicenter randomized trial, a patient's admission inflammatory status was associated with their response to nutritional support. If validated in future clinical trials, nutritional support may need to be individualized based on a patient's initial presentation and markers of inflammation. These results may also help to explain some of the heterogeneity in treatment effects of nutrition seen in previous critical care trials.
Trial Registration


ClinicalTrials.gov Identifier: NCT02517476.",2020,"Compared with the control group, patients receiving nutritional support showed a significant reduction in 30-day mortality, regardless of C-reactive protein level (adjusted odds ratio, 0.61; 95% CI, 0.43-0.86; P = .005).","['Interventions\n\n\nHospitalized patients at risk for malnutrition', 'Patients With Disease-Related Malnutrition', 'patients with disease-related malnutrition', '1950 participants who had C-reactive protein measurements at the time of admission were included in this secondary analysis', '1950 patients (median [interquartile range] age, 75 [65-83] years; 1025 [52.6%] men) were included; 533 (27.3%) had low levels of inflammation, 894 (45.9%) had moderate levels of inflammation, and 523 (26.8%) had high levels of inflammation', '8 Swiss hospitals from April 2014 to February 2018']","['protocol-guided individualized nutritional support to reach protein and energy goals (intervention group) or standard hospital food (control group', 'Nutritional Support']","['30-day mortality, regardless of C-reactive protein level', '30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184549', 'cui_str': 'At risk for malnutrition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.131781,"Compared with the control group, patients receiving nutritional support showed a significant reduction in 30-day mortality, regardless of C-reactive protein level (adjusted odds ratio, 0.61; 95% CI, 0.43-0.86; P = .005).","[{'ForeName': 'Meret', 'Initials': 'M', 'LastName': 'Merker', 'Affiliation': 'Medical University Department, University of Basel, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Felder', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Gueissaz', 'Affiliation': 'University of Basel, Basel, Switzerland.'}, {'ForeName': 'Rebekka', 'Initials': 'R', 'LastName': 'Bolliger', 'Affiliation': 'Medical University Department, University of Basel, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tribolet', 'Affiliation': 'Department of Health Professions, Bern University of Applied Sciences, Bern, Switzerland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kägi-Braun', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Muensterlingen, Switzerland.'}, {'ForeName': 'Filomena', 'Initials': 'F', 'LastName': 'Gomes', 'Affiliation': 'New York Academy of Sciences, New York.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Hoess', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Muensterlingen, Switzerland.'}, {'ForeName': 'Vojtech', 'Initials': 'V', 'LastName': 'Pavlicek', 'Affiliation': 'Internal Medicine, Kantonsspital Muensterlingen, Muensterlingen, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bilz', 'Affiliation': 'Internal Medicine and Endocrinology/Diabetes, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sigrist', 'Affiliation': 'Internal Medicine and Endocrinology/Diabetes, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brändle', 'Affiliation': 'Internal Medicine and Endocrinology/Diabetes, Kantonsspital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Henzen', 'Affiliation': 'Internal Medicine, Kantonsspital Luzern, Luzern, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Thomann', 'Affiliation': 'Internal Medicine, Kantonsspital Solothurn, Solothurn, Switzerland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Rutishauser', 'Affiliation': 'Internal Medicine, Kantonsspital Baselland, Baselland, Switzerland.'}, {'ForeName': 'Drahomir', 'Initials': 'D', 'LastName': 'Aujesky', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jaques', 'Initials': 'J', 'LastName': 'Donzé', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Zeno', 'Initials': 'Z', 'LastName': 'Stanga', 'Affiliation': 'Division of Diabetology, Endocrinology, Nutritional Medicine, and Metabolism, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Mueller', 'Affiliation': 'Medical University Department, University of Basel, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Schuetz', 'Affiliation': 'Medical University Department, University of Basel, Kantonsspital Aarau, Aarau, Switzerland.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.0663']
3075,31785275,"A multicenter, single-blind randomized controlled trial of endoscopic clipping closure for preventing coagulation syndrome after colorectal endoscopic submucosal dissection.","BACKGROUND AND AIMS


Post endoscopic submucosal dissection coagulation syndrome (PECS) occasionally occurs after colorectal endoscopic submucosal dissection (ESD), presenting with localized abdominal pain and inflammation. We conducted a randomized controlled trial (RCT) to assess the usefulness of endoscopic clipping closure to prevent PECS and delayed perforation (DP).
METHODS


This is a multicenter, single-blind RCT. Prospectively enrolled patients undergoing colorectal ESD were randomly allocated to endoscopic clipping closure and nonclosure after ESD, stratifying by institution and tumor size. All participants underwent a computed tomography scan after ESD. PECS was defined as visual analog scale (VAS) ≥30 mm, an increase in VAS ≥20 mm from baseline, body temperature ≥37.5°C or white blood cells ≥10,000/μL after colorectal ESD. DP was defined as PECS accompanied by extraluminal air. The preplanned sample size was 320 patients, and the primary endpoint was the rate of PECS/DP.
RESULTS


At the planned interim analysis, this trial was terminated by recommendation of the independent data and safety monitoring committee because conditional power with superiority was lower than the preplanned futility limit. Finally, 155 patients were analyzed. The rate of PECS/DP was 16% (95% confidence interval [CI], 8%-23%) in the nonclosure group and 24% (95% CI, 14%-34%) in the closure group (P = .184). All cases of DP were within minor criteria, and all PECS/DP patients were managed conservatively without surgical treatment. Simple periluminal air without PECS was observed in 16% (95% CI, 8%-23%) in the nonclosure group and 10% (95% CI, 3%-17%) in the closure group.
CONCLUSION


Endoscopic clipping closure could not reduce the high incidence of PECS/DP after colorectal ESD. (University Hospital Medical Network Clinical Trials Registry number: UMIN000027031.).",2020,"PECS/DP's rate was 16 (95 % confidence interval [CI], 8%-23%) in the nonclosure and 24 (95% CI, 14%-34%) in the closure groups, respectively (P = 0.184).","['Prospectively enrolled patients undergoing colorectal ESD', '155 patients were analyzed']","['endoscopic clipping closure', 'endoscopic clipping closure to prevent PECS and delayed perforation (PECS/DP']","[""PECS/DP's rate"", 'Simple periluminal air without PECS', 'rate of PECS/DP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}]","[{'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0318599', 'cui_str': 'Porcine enteric calicivirus (organism)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]",320.0,0.222398,"PECS/DP's rate was 16 (95 % confidence interval [CI], 8%-23%) in the nonclosure and 24 (95% CI, 14%-34%) in the closure groups, respectively (P = 0.184).","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Department of Gastroenterology, Nagoya City West Medical Center, 1-1-1 Hirate, Kita-ku, Nagoya 462-8508, Japan.'}, {'ForeName': 'Takaya', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Katano', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Iwai', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa 442-8561, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya 466-0814, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, 2-9 Myoken-cho, Showa-ku, Nagoya 466-0814, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Ebi', 'Affiliation': 'Department of Gastroenterology, Aichi Medical University, 1-1 Karimata, Iwasaku, Nagakute 480-1195, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Hirata', 'Affiliation': 'Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takagi, Kasugai 486-8510, Japan.'}, {'ForeName': 'Hirotada', 'Initials': 'H', 'LastName': 'Nishie', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, 5-161 Maehata, Tajimi 507-8522, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Togawa', 'Affiliation': 'Department of Gastroenterology, Nagoya Memorial Hospital, 4-305 Hirabari, Tenpaku-ku, Nagoya 468-8520, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Shibata', 'Affiliation': 'Department of Gastroenterology, Toyokawa City Hospital, 23 Noji, Yahata, Toyokawa 442-8561, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.11.030']
3076,30933599,Effects Of Alternative Food Voucher Delivery Strategies On Nutrition Among Low-Income Adults.,"Nutrition assistance programs are the subject of ongoing policy debates. Two proposals remain uninformed by existing evidence: whether restricting benefits to allow only fruit and vegetable purchases improves overall dietary intake, and whether more frequent distribution of benefits (weekly versus monthly) induces more fruit and vegetable consumption and less purchasing of calorie-dense foods. In a community-based trial, we randomly assigned participants to receive food vouchers that differed in what foods could be purchased (fruit and vegetables only or any foods) and in distribution schedule (in weekly or monthly installments, holding total monthly value constant). The use of vouchers for fruit and vegetables only did not yield significantly greater improvements than the unrestricted voucher did in terms of fruit and vegetable consumption or Healthy Eating Index (HEI) score. Weekly vouchers also failed to yield significantly greater improvements than monthly vouchers did. Proposed policies to make assistance more restricted or more frequent, while holding benefit value constant, might not improve nutrition among low-income Americans.",2019,The use of vouchers for fruit and vegetables only did not yield significantly greater improvements than the unrestricted voucher did in terms of fruit and vegetable consumption or Healthy Eating Index (HEI) score.,['Low-Income Adults'],"['food vouchers that differed in what foods could be purchased (fruit and vegetables only or any foods) and in distribution schedule', 'Alternative Food Voucher Delivery Strategies']",['fruit and vegetable consumption or Healthy Eating Index (HEI) score'],"[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0286545,The use of vouchers for fruit and vegetables only did not yield significantly greater improvements than the unrestricted voucher did in terms of fruit and vegetable consumption or Healthy Eating Index (HEI) score.,"[{'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Sanjay Basu ( basus@stanford.edu ) is an assistant professor of medicine in the Center for Primary Care and Outcomes Research and the Center for Population Health Sciences, both in the Department of Medicine, Stanford University School of Medicine, in California.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Christopher D. Gardner is a professor of medicine at the Stanford University School of Medicine.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'White', 'Affiliation': 'Justin S. White is an assistant professor at the Philip R. Lee Institute for Health Policy Studies, University of California San Francisco (UCSF).'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rigdon', 'Affiliation': 'Joseph Rigdon is a senior biostatistician in the Quantitative Sciences Unit at the Stanford University School of Medicine.'}, {'ForeName': 'Mandy M', 'Initials': 'MM', 'LastName': 'Carroll', 'Affiliation': 'Mandy M. Carroll is a study coordinator in the Department of Medicine, Stanford University School of Medicine.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Akers', 'Affiliation': 'Melissa Akers is a study coordinator in the Division of General Internal Medicine at UCSF.'}, {'ForeName': 'Hilary K', 'Initials': 'HK', 'LastName': 'Seligman', 'Affiliation': 'Hilary K. Seligman is an associate professor of medicine at UCSF.'}]",Health affairs (Project Hope),['10.1377/hlthaff.2018.05405']
3077,31187126,"Effectiveness and Cost of Organized Outreach for Colorectal Cancer Screening: A Randomized, Controlled Trial.","BACKGROUND


Colorectal cancer (CRC) screening remains underused, especially in safety-net systems. The objective of this study was to determine the effectiveness, costs, and cost-effectiveness of organized outreach using fecal immunochemical tests (FITs) compared with usual care.
METHODS


Patients age 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics were randomly assigned to outreach intervention with usual care vs usual care alone. The intervention included a mailed postcard and call, followed by a mailed FIT kit, and a reminder phone call if the FIT kit was not returned. The primary outcome was screening participation at 1 year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach. All statistical tests were two-sided.
RESULTS


A total of 5386 patients were randomly assigned to the intervention group and 5434 to usual care. FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs 37.4%, P < .001; difference = 20.5%, 95% confidence interval = 18.6% to 22.4%). In the intervention group, FIT completion rate was higher in patients who had previously completed a FIT vs those who had not (71.9% vs 35.7%, P < .001). There was evidence of effect modification of the intervention by language, and clinic. Outreach cost approximately $23 per patient and $112 per additional patient screened. Projecting long-term outcomes, outreach was estimated to cost $9200 per quality-adjusted life-year gained vs usual care.
CONCLUSION


Population-based management with organized FIT outreach statistically significantly increased CRC screening and was cost-effective in a safety-net system. The sustainability of the program and any impact of economies of scale remain to be determined.",2020,"FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs. 37.4%, P < 0.001; difference 20.5%, 95% CI 18.6-22.4%).","['colorectal cancer screening', '5,386 patients', 'Patients aged 50-75 years eligible for CRC screening from eight participating primary care safety-net clinics']","['outreach intervention with usual care versus usual care alone', 'organized outreach', 'organized outreach using fecal immunochemical tests (FIT']","['FIT completion rate', 'FIT screening', 'effectiveness, costs, and cost-effectiveness', 'Outreach cost', 'screening participation at one year and a microcosting analysis of the outreach activities with embedded long-term cost-effectiveness of outreach', 'CRC screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3661444', 'cui_str': 'Safety-net Clinics'}]","[{'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]",5386.0,0.109557,"FIT screening was statistically significantly higher in the intervention group than in the control group (57.9% vs. 37.4%, P < 0.001; difference 20.5%, 95% CI 18.6-22.4%).","[{'ForeName': 'Ma', 'Initials': 'M', 'LastName': 'Somsouk', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Rachocki', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Ajitha', 'Initials': 'A', 'LastName': 'Mannalithara', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, CA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Laleau', 'Affiliation': 'Division of Gastroenterology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grimes', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Rachel B', 'Initials': 'RB', 'LastName': 'Issaka', 'Affiliation': 'Clinical Research and Public Health Sciences Divisions, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vittinghoff', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Shapiro', 'Affiliation': 'CDC, Atlanta, GA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Ladabaum', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Stanford University, Stanford, CA.'}]",Journal of the National Cancer Institute,['10.1093/jnci/djz110']
3078,31833801,"Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial.","Background:  The aim was to assess the safety and tolerability of the insulin aspart biosimilar/follow-on product SAR341402 (100 U/mL solution; SAR-Asp) and originator insulin aspart (100 U/mL; NN-Asp; NovoLog ® ) self-administered through an insulin pump.  Materials and Methods:  This randomized, open-label, 2 × 4-week crossover study enrolled 45 adults with type 1 diabetes (T1D). Participants were randomized 1:1 to the treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp. The basal and prandial insulin doses were individually titrated. The primary outcome was the number of participants with at least one infusion set occlusion (infusion set change due to failure-to-correct hyperglycemia [plasma glucose ≥250 mg/dL] by insulin pump bolus) during the 4-week treatment. The main secondary outcome was the number of participants with at least one episode of unexplained hyperglycemia (regardless of correction by an insulin pump bolus without apparent material defect, medical, dietary, insulin dosing reason, or pump problem).  Results:  The number of participants reporting ≥1 infusion set occlusion were similar between treatments: 14/43 on SAR-Asp (33 events) and 12/43 on NN-Asp (24 events). The estimated difference in infusion set occlusion risk for SAR-Asp versus NN-Asp was 4.1% (95% confidence interval: -9.3% to 17.4%). The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]). Hypoglycemia, treatment-emergent adverse events, hypersensitivity, and injection site reactions were similar between treatments.  Conclusions:  SAR-Asp and NN-Asp were well tolerated and had similar infusion set occlusions over a 4-week period in insulin pump users with T1D.",2020,The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]).,"['45 adults with type 1 diabetes (T1D', 'Adults with Type 1 Diabetes']","['insulin aspart biosimilar/follow-on product SAR341402 (100\u2009U/mL solution; SAR-Asp) and originator insulin aspart', 'Insulin Aspart Biosimilar SAR341402', 'Originator Insulin Aspart (NovoLog', 'treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp']","['safety and tolerability', 'number of participants with at least one infusion set occlusion (infusion set change due to failure-to-correct hyperglycemia [plasma glucose', 'number of participants with at least one episode of unexplained hyperglycemia (regardless of correction by an insulin pump bolus without apparent material defect, medical, dietary, insulin dosing reason, or pump problem', 'Hypoglycemia, treatment-emergent adverse events, hypersensitivity, and injection site reactions', 'number of participants reporting ≥1 infusion set occlusion', 'unexplained hyperglycemia', 'Safety and Tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1175743', 'cui_str': 'Severe acute respiratory syndrome-related coronavirus'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}, {'cui': 'C0939412', 'cui_str': 'NovoLog'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",45.0,0.133699,The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thrasher', 'Affiliation': 'Medical Investigations, Inc., Little Rock, Arkansas.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'Department of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Hovsepian', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nowotny', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Pierre', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Bois De Fer', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes & Endocrinology Research Center, West Des Moines, Iowa.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'Department of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado, Denver, Colorado.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0446']
3079,32202593,Association of Sleep-Disordered Breathing With Alzheimer Disease Biomarkers in Community-Dwelling Older Adults: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Increasing evidence suggests that sleep-disordered breathing (SDB) increases the risk of developing Alzheimer clinical syndrome. However, the brain mechanisms underlying the link between SDB and Alzheimer disease are still unclear.
Objective


To determine which brain changes are associated with the presence of SDB in older individuals who are cognitively unimpaired, including changes in amyloid deposition, gray matter volume, perfusion, and glucose metabolism.
Design, Setting, and Participants


This cross-sectional study was conducted using data from the Age-Well randomized clinical trial of the Medit-Ageing European project, acquired between 2016 and 2018 at Cyceron Center in Caen, France. Community-dwelling older adults were assessed for eligibility and were enrolled in the Age-Well clinical trial if they did not meet medical or cognitive exclusion criteria and were willing to participate. Participants who completed a detailed neuropsychological assessment, polysomnography, a magnetic resonance imaging, and florbetapir and fluorodeoxyglucose positron emission tomography scans were included in the analyses.
Main Outcomes and Measures


Based on an apnea-hypopnea index cutoff of 15 events per hour, participants were classified as having SDB or not. Voxelwise between-group comparisons were performed for each neuroimaging modality, and secondary analyses aimed at identifying which SDB parameter (sleep fragmentation, hypoxia severity, or frequency of respiratory disturbances) best explained the observed brain changes and assessing whether SDB severity and/or SDB-associated brain changes are associated with cognitive and behavioral changes.
Results


Of 157 participants initially assessed, 137 were enrolled in the Age-Well clinical trial, and 127 were analyzed in this study. The mean (SD) age of the 127 participants was 69.1 (3.9) years, and 80 (63.0%) were women. Participants with SDB showed greater amyloid burden (t114 = 4.51; familywise error-corrected P = .04; Cohen d, 0.83), gray matter volume (t119 = 4.12; familywise error-corrected P = .04; Cohen d, 0.75), perfusion (t116 = 4.62; familywise error-corrected P = .001; Cohen d, 0.86), and metabolism (t79 = 4.63; familywise error-corrected P = .001; Cohen d, 1.04), overlapping mainly over the posterior cingulate cortex and precuneus. No association was found with cognition, self-reported cognitive and sleep difficulties, or excessive daytime sleepiness symptoms.
Conclusions and Relevance


The SDB-associated brain changes in older adults who are cognitively unimpaired include greater amyloid deposition and neuronal activity in Alzheimer disease-sensitive brain regions, notably the posterior cingulate cortex and precuneus. These results support the need to screen and treat for SDB, especially in asymptomatic older populations, to reduce Alzheimer disease risk.
Trial Registration


ClinicalTrials.gov Identifier: NCT02977819.",2020,"Participants with SDB showed greater amyloid burden (t114 = 4.51; familywise error-corrected P = .04; Cohen d, 0.83), gray matter volume (t119 = 4.12; familywise error-corrected P = .04; Cohen d, 0.75), perfusion (t116 = 4.62; familywise error-corrected P = .001; Cohen d, 0.86), and metabolism (t79 = 4.63; familywise error-corrected P = ","['Community-dwelling older adults were assessed for eligibility and were enrolled in the Age-Well clinical trial if they did not meet medical or cognitive exclusion criteria and were willing to participate', 'Participants who completed a detailed neuropsychological assessment, polysomnography, a magnetic resonance imaging, and florbetapir and fluorodeoxyglucose positron emission tomography scans were included in the analyses', '137 were enrolled in the Age-Well clinical trial, and 127 were analyzed in this study', 'The mean (SD) age of the 127 participants was 69.1 (3.9) years, and 80 (63.0%) were women', 'older adults', 'Community-Dwelling Older Adults', 'Participants\n\n\nThis cross-sectional study was conducted using data from the Age-Well randomized clinical trial of the Medit-Ageing European project, acquired between 2016 and 2018 at Cyceron Center in Caen, France', '157 participants', 'older individuals who are cognitively unimpaired']","['sleep-disordered breathing (SDB', 'Sleep-Disordered Breathing']","['SDB parameter (sleep fragmentation, hypoxia severity, or frequency of respiratory disturbances', 'gray matter volume', 'apnea-hypopnea index cutoff', 'cognition, self-reported cognitive and sleep difficulties, or excessive daytime sleepiness symptoms', 'amyloid burden']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2963171', 'cui_str': 'Ageing Well'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C2742211', 'cui_str': 'florbetapir'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0441633'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0751507', 'cui_str': 'Sleep Fragmentation'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}]",137.0,0.103428,"Participants with SDB showed greater amyloid burden (t114 = 4.51; familywise error-corrected P = .04; Cohen d, 0.83), gray matter volume (t119 = 4.12; familywise error-corrected P = .04; Cohen d, 0.75), perfusion (t116 = 4.62; familywise error-corrected P = .001; Cohen d, 0.86), and metabolism (t79 = 4.63; familywise error-corrected P = ","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'André', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Rehel', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Landeau', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Inès', 'Initials': 'I', 'LastName': 'Moulinet', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Edelweiss', 'Initials': 'E', 'LastName': 'Touron', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Ourry', 'Affiliation': 'Normandie Université, Université de Caen, Paris Sciences & Lettres Université, École Pratique des Hautes Études, Institut National de la Santé et de la Recherche Médicale, Unité 1077 ""Neuropsychologie et Imagerie de la Mémoire Humaine,"" Centre Hospitalier Universitaire de Caen, GIP Cyceron, Caen, France.'}, {'ForeName': 'Gwendoline', 'Initials': 'G', 'LastName': 'Le Du', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mézenge', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Tomadesso', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'de Flores', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Bejanin', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Siya', 'Initials': 'S', 'LastName': 'Sherif', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delcroix', 'Affiliation': 'Centre National de la Recherche Scientifique, Unité Mixte de Service 3048, GIP Cyceron, Caen, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Manrique', 'Affiliation': 'Normandie Université, Université de Caen, EA 4650 ""Signalisation, Électrophysiologie et Imagerie des Lésions d\'Ischémie-Reperfusion Myocardique"", GIP Cyceron, Caen, France.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abbas', 'Affiliation': 'Normandie Université, Université de Caen, Paris Sciences & Lettres Université, École Pratique des Hautes Études, Institut National de la Santé et de la Recherche Médicale, Unité 1077 ""Neuropsychologie et Imagerie de la Mémoire Humaine,"" Centre Hospitalier Universitaire de Caen, GIP Cyceron, Caen, France.'}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Marchant', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lutz', 'Affiliation': 'Lyon Neuroscience Research Center, Institut National de la Santé et de la Recherche Médicale Unité 1028, Centre National de la Recherche Scientifique Unité Mixte de Recherche 5292, Lyon University, Lyon, France.'}, {'ForeName': 'Olga M', 'Initials': 'OM', 'LastName': 'Klimecki', 'Affiliation': 'Swiss Center for Affective Sciences, Department of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Collette', 'Affiliation': 'GIGA-Cyclotron Research Centre, In Vivo Imaging and Psychology and Cognitive Neuroscience Unit, Liège University, Liège, Belgium.'}, {'ForeName': 'Eider M', 'Initials': 'EM', 'LastName': 'Arenaza-Urquijo', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Poisnel', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Vivien', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Bertran', 'Affiliation': ""Unité d'Exploration et de Traitement des Troubles du Sommeil, Centre Hospitalier Universitaire de Caen, Caen, France.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'de la Sayette', 'Affiliation': 'Normandie Université, Université de Caen, Paris Sciences & Lettres Université, École Pratique des Hautes Études, Institut National de la Santé et de la Recherche Médicale, Unité 1077 ""Neuropsychologie et Imagerie de la Mémoire Humaine,"" Centre Hospitalier Universitaire de Caen, GIP Cyceron, Caen, France.'}, {'ForeName': 'Gaël', 'Initials': 'G', 'LastName': 'Chételat', 'Affiliation': 'Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 ""Physiopathology and Imaging of Neurological Disorders,"" Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Rauchs', 'Affiliation': 'Normandie Université, Université de Caen, Paris Sciences & Lettres Université, École Pratique des Hautes Études, Institut National de la Santé et de la Recherche Médicale, Unité 1077 ""Neuropsychologie et Imagerie de la Mémoire Humaine,"" Centre Hospitalier Universitaire de Caen, GIP Cyceron, Caen, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2020.0311']
3080,31486694,Novel Triamcinolone Acetonide-Loaded Liposomal Topical Formulation Improves Contrast Sensitivity Outcome After Femtosecond Laser-Assisted Cataract Surgery.,"Purpose:  To assess visual results, macular modifications, and the incidence of clinically significant macular edema (CSME) in patients using a topical triamcinolone acetonide-loaded liposomal formulation (TA-LF) after femtosecond laser-assisted cataract surgery (FLACS).  Methods:  Fifty-six eyes after FLACS were selected. Twenty-eight eyes in the combined therapy group (P + N) were treated with prednisolone 1% and nepafenac 0.1% for 21 days postoperatively, whereas 28 eyes in the TA-LF group received a liposomal formulation containing 2 mg/mL of TA (0.2%) for the same period of time. Follow-up visits at 1 day, 6 weeks, and 12 weeks after surgery consisted of visual acuity, contrast sensitivity (CS), central foveal thickness (CFT), total macular volume (TMV) measurements, and the detection of CSME.  Results:  CS improved in the TA-LF group (basal value: 1.087 ± 0.339 vs. 1.276 ± 0.147 at week 12,  P  = 0.0346), whereas in the P + N group, CS was not different from the baseline (basal value: 1.130 ± 0.331 vs. 1.274 ± 0.133 at week 12,  P  = 0.1276). There were similar increases in postoperative CFT and TMV in both groups. CFT and TMV significantly correlate with CS only in the TA-LF group. The  r 2  for CFT and CS was 0.1963 ( P  = 0.0206), whereas the  r 2  for TMV and CS was 0.3615 ( P  = 0.0007) at 12 weeks. No difference was observed in the incidence of CSME between the groups.  Conclusion:  TA-LF is associated with better CS outcomes compared to combined therapy after FLACS.",2019,No difference was observed in the incidence of CSME between the groups.  ,"['Methods:  Fifty-six eyes after FLACS were selected', 'patients using a']","['Triamcinolone Acetonide-Loaded Liposomal Topical Formulation', 'topical triamcinolone acetonide-loaded liposomal formulation (TA-LF', 'femtosecond laser-assisted cataract surgery (FLACS', 'liposomal formulation containing 2\u2009mg/mL of TA', 'prednisolone 1% and nepafenac', 'Femtosecond Laser-Assisted Cataract Surgery']","['incidence of CSME', 'postoperative CFT and TMV', 'CFT and TMV', 'visual acuity, contrast sensitivity (CS), central foveal thickness (CFT), total macular volume (TMV) measurements, and the detection of CSME', 'Contrast Sensitivity Outcome']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",,0.043019,No difference was observed in the incidence of CSME between the groups.  ,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Gonzalez-De la Rosa', 'Affiliation': 'Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Zapopan, Mexico.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Navarro-Partida', 'Affiliation': 'Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Zapopan, Mexico.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Altamirano-Vallejo', 'Affiliation': 'Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Zapopan, Mexico.'}, {'ForeName': 'Gerardo Daniel', 'Initials': 'GD', 'LastName': 'Jauregui-Garcia', 'Affiliation': 'Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Zapopan, Mexico.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Acosta-Gonzalez', 'Affiliation': 'Centro Médico Puerta de Hierro, Zapopan, Mexico.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Ibanez-Hernandez', 'Affiliation': 'Centro Médico Puerta de Hierro, Zapopan, Mexico.'}, {'ForeName': 'Guadalupe Fernando', 'Initials': 'GF', 'LastName': 'Mora-Gonzalez', 'Affiliation': 'Centro Médico Puerta de Hierro, Zapopan, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Armendáriz-Borunda', 'Affiliation': 'Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Zapopan, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Santos', 'Affiliation': 'Tecnológico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Zapopan, Mexico.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0032']
3081,31613699,Transzonular Triamcinolone-Moxifloxacin Versus Topical Drops for the Prophylaxis of Postoperative Inflammation After Cataract Surgery.,"Purpose:  To compare the safety and efficacy of an intraoperative transzonular injection of triamcinolone-moxifloxacin (Imprimis' Tri-Moxi 15 mg/1 mg/mL) to topical drops in patients undergoing cataract surgery.  Methods:  Between January 2017 and October 2017, patients undergoing phacoemulsification cataract surgery by a single surgeon at the Penn State Eye Center were offered a single intraoperative injection of transzonular triamcinolone-moxifloxacin in lieu of perioperative drops. Between November 2017 and July 2018, the transzonular injection was not offered, and all patients who underwent surgery by the same surgeon received a drop regimen consisting of polymyxin b/trimethoprim and prednisolone acetate 1%. Patients were seen 1 day, 1 week, and 6-9 weeks postoperatively. Outcome measures included incidence of intraoperative complications, postoperative breakthrough inflammation, cystoid macular edema, and infectious sequela.  Results:  Of the 198 eyes, 99 from 73 patients received the injection and 99 from 82 patients received topical drops. One (1%) intraoperative posterior capsule tear occurred in each group. Eleven (11.1%) eyes in the injection group and 3 (3%) in the drop group experienced symptomatic breakthrough inflammation necessitating treatment ( P  = 0.0488). One (1%) eye in the injection group and zero (0%) in the drop group developed clinically significant macular edema ( P  = 1.0). No instances of elevated intraocular pressure or infectious sequela occurred in either group ( P  = 1.0).  Conclusions:  Transzonular injection of triamcinolone-moxifloxacin may be associated with an increased incidence of breakthrough inflammation compared to topical drops.",2019,No instances of elevated intraocular pressure or infectious sequela occurred in either group ( P  = 1.0).  ,"['patients undergoing phacoemulsification cataract surgery by a single surgeon at the Penn State Eye Center', 'January 2017 and October 2017', 'patients undergoing cataract surgery', '198 eyes']","['triamcinolone-moxifloxacin', 'transzonular triamcinolone-moxifloxacin', ""triamcinolone-moxifloxacin (Imprimis' Tri-Moxi 15\u2009mg/1\u2009mg/mL"", 'topical drops', 'Transzonular Triamcinolone-Moxifloxacin Versus Topical Drops', 'polymyxin b/trimethoprim and prednisolone acetate']","['Postoperative Inflammation', 'intraoperative posterior capsule tear', 'symptomatic breakthrough inflammation necessitating treatment', 'breakthrough inflammation', 'incidence of intraoperative complications, postoperative breakthrough inflammation, cystoid macular edema, and infectious sequela', 'clinically significant macular edema', 'elevated intraocular pressure or infectious sequela', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2193446', 'cui_str': 'Phacoemulsification'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0722704', 'cui_str': 'Polymyxin B / Trimethoprim'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1536084', 'cui_str': 'Posterior capsule tear'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0024440', 'cui_str': 'Macular Dystrophy, Dominant Cystoid'}, {'cui': 'C0543419', 'cui_str': 'Sequelae of disorders (disorder)'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema (disorder)'}, {'cui': 'C0234708', 'cui_str': 'Raised intraocular pressure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0705051,No instances of elevated intraocular pressure or infectious sequela occurred in either group ( P  = 1.0).  ,"[{'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Singhal', 'Affiliation': 'Department of Ophthalmology and Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology and Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Ophthalmology and Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Department of Ophthalmology and Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Pantanelli', 'Affiliation': 'Department of Ophthalmology and Penn State College of Medicine, Hershey, Pennsylvania.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0097']
3082,31999297,Characteristics of Eyes With Good Visual Acuity at 5 Years After Initiation of Treatment for Age-Related Macular Degeneration but Not Receiving Treatment From Years 3 to 5: Post Hoc Analysis of the CATT Randomized Clinical Trial.,"Importance


Identifying the characteristics of eyes with neovascular age-related macular degeneration (nAMD) that maintain good vision without anti-vascular endothelial growth factor treatment for at least 3 years after management, as occurred in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT), may have prognostic importance and help in understanding the disease and its treatment.
Objectives


To ascertain the characteristics of eyes in the CATT that retained good vision despite receiving no therapy for 3 years after release from the 2-year CATT treatment protocol.
Design, Setting and Participants


This case-control study analyzed the baseline and follow-up characteristics of eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009. After initial randomization to 1 of 4 treatment groups (ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, or bevacizumab as needed), at year 1, participants in the monthly groups were rerandomized to continue monthly treatment or to switch to as-needed treatment using the same drug as originally assigned. At year 2, participants were released from the protocol to treatment at the discretion of their ophthalmologist. At year 5, participants were recalled for examination. This present analysis, conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group).
Main Outcomes and Measures


Visual acuity, morphologic characteristics, and number of treatments over 5 years.
Results


Among 625 eyes with nAMD at baseline and a visual acuity measurement at year 5, 40 (6.4%; 95% CI, 4.7%-8.7%) were included in the analysis. These 40 participants, compared with the other group (n = 585), had a lower mean (SD) age of 74.7 (7.3) years (vs 77.7 [7.3] years; P = .01) and included 26 women (65.0%). Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02). Eyes in the CTGVA group with as-needed treatment received fewer mean (SD) injections in year 1 (5.8 [4.0] vs 8.1 [3.5]) and year 2 (7.7 [5.7] vs 13.8 [6.8]) than eyes in the other as-needed group. Mean (SD) visual acuity letter score at 5 years was 79.0 (5.5; Snellen 20/25) in the CTGVA group and 57.5 (24.2; Snellen 20/80) in the other group.
Conclusions and Relevance


These findings suggest that a small proportion of eyes with nAMD can retain good visual acuity with no treatment for at least 3 years after the initial 2 years of treatment. Unique characteristics of eyes that could discontinue treatment while maintaining good visual acuity could not be identified at baseline, but data suggest that not all eyes with this disease may need treatment forever.
Trial Registration


ClinicalTrials.gov Identifier: NCT00593450.",2020,"Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02).","['625 eyes with nAMD at baseline and a', 'eyes with nAMD that were enrolled in the CATT from 43 US clinical centers between February 20, 2008, and December 9, 2009', 'Eyes With Good Visual Acuity at 5 Years', 'conducted from December 1, 2018, to September 30, 2019, compared the eyes of 40 participants (referred to as the cessation of treatment with good visual acuity, or CTGVA, group) with the eyes of the remainder of the CATT Follow-up Study (referred to as the other group', 'eyes with neovascular age-related macular degeneration (nAMD']","['ranibizumab monthly, bevacizumab monthly, ranibizumab', 'CTGVA']","['visual acuity', 'good visual acuity', 'visual acuity letter score', 'Measures\n\n\nVisual acuity, morphologic characteristics, and number of treatments over 5 years', 'fellow eye', 'visual acuity measurement', 'Mean (SD) visual acuity letter score']","[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0871549', 'cui_str': 'Cessation of Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",26.0,0.215636,"Baseline characteristics were similar between eyes in the CTGVA and other groups, except for better visual acuity letter score in the study eye (68.8 vs 61.8; P = .001) and the fellow eye (78.4 vs 68.0; P = .01) as well as the presence of blocked fluorescence seen more often in participants in the CTGVA vs the other group (27.5% vs 13.8%; P = .02).","[{'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Scoles', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peiying', 'Initials': 'P', 'LastName': 'Hua', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Juan E', 'Initials': 'JE', 'LastName': 'Grunwald', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Daniel', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Toth', 'Affiliation': 'Duke Eye Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, The Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5831']
3083,31738382,Age-Related Differences in the Noninvasive Evaluation for Possible Coronary Artery Disease: Insights From the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Trial.,"Importance


Although cardiovascular (CV) disease represents the leading cause of morbidity and mortality that increases with age, the best noninvasive test to identify older patients at risk for CV events remains unknown.
Objective


To determine whether the prognostic utility of anatomic vs functional testing varies based on patient age.
Design, Setting, and Participants


Prespecified analysis of the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) study, which used a pragmatic comparative effectiveness design. Participants were enrolled from 193 sites across North America and comprised outpatients without known coronary artery disease (CAD) but with symptoms suggestive of CAD. Data were analyzed between October 2018 and April 2019.
Interventions


Randomization to noninvasive testing with coronary computed tomographic angiography or functional testing.
Main Outcomes and Measures


The composite of CV death/myocardial infarction (MI) over a median follow-up of 25 months.
Results


Among 10 003 PROMISE patients, we included the 8966 who received the noninvasive test to which they were randomized and had interpretable results; 6378 (71.1%) were younger than 65 years, 2062 (23.0%) were between ages 65 and 74 years, and 526 (5.9%) were 75 years and older. More than half of participants were women (4720 of 8966 [52.6%]). Only a minority of patients were of nonwhite race/ethnicity, a proportion that was lower among the older age groups (1071 of 6378 [16.8%] for <65 years; 258 of 2062 [12.5%] for age 65-74 years; 41 of 526 [7.8%] for ≥75 years). Compared with patients younger than 65 years, older patients were more likely to have a positive test result (age 65-74 years: odds ratio, 1.65; 95% CI, 1.42-1.91; age ≥75 years: odds ratio, 2.32; 95% CI, 1.83-2.95), regardless of noninvasive test completed. A positive functional test result was not associated with CV death/MI in patients younger than 65 years (hazard ratio [HR], 1.09; 95% CI, 0.43-2.82) but it was among older patients (age 65-74 years: HR, 3.18; 95% CI, 1.44-7.01; age ≥75 years: HR, 6.55; 95% CI, 1.46-29.35). Conversely, a positive anatomic test result was associated with CV death/MI among patients younger than 65 years (HR, 3.04; 95% CI, 1.46-6.34) but not among older patients (age, 65-74 years: HR, 0.67; 95% CI, 0.15-2.94; age ≥75 years: HR, 1.07; 95% CI, 0.22-5.34; P for interaction = .01). An elevated coronary artery calcium score was predictive of events in patients younger than 65 years (HR, 2.73; 95% CI, 1.31-5.69) but not for older patients (age 65-74 years: HR, 0.44; 95% CI, 0.14-1.42; age ≥75 years: HR, 1.31; 95% CI, 0.25-6.88).
Conclusions and Relevance


Older patients with stable symptoms suggestive of CAD are more likely to have a positive noninvasive test result and more coronary artery calcium. However, only a positive functional test result was associated with risk of CV death/MI. Age-specific approaches to noninvasive evaluation of CAD should be further examined.
Trial Registration


ClinicalTrials.gov identifier: NCT01174550.",2020,"A positive functional test result was not associated with CV death/MI in patients younger than 65 years (hazard ratio [HR], 1.09; 95% CI, 0.43-2.82) but it was among older patients (age 65-74 years: HR, 3.18; 95% CI, 1.44-7.01; age ≥75 years: HR, 6.55; 95% CI, 1.46-29.35).","['Only a minority of patients were of nonwhite race/ethnicity, a proportion that was lower among the older age groups (1071 of 6378 [16.8%] for <65 years; 258 of 2062 [12.5%] for age 65-74 years; 41 of 526 [7.8%] for ≥75 years', 'Among 10\u202f003 PROMISE patients, we included the 8966 who received the noninvasive test to which they were randomized and had interpretable results; 6378 (71.1%) were younger than 65 years, 2062 (23.0%) were between ages 65 and 74 years, and 526 (5.9%) were 75 years and older', 'Participants were enrolled from 193 sites across North America and comprised outpatients without known coronary artery disease (CAD) but with symptoms suggestive of CAD', 'Older patients with stable symptoms suggestive of CAD']",['coronary computed tomographic angiography or functional testing'],"['risk of CV death/MI', 'elevated coronary artery calcium score', 'composite of CV death/myocardial infarction (MI', 'CV death/MI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517591', 'cui_str': '16.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",,0.167803,"A positive functional test result was not associated with CV death/MI in patients younger than 65 years (hazard ratio [HR], 1.09; 95% CI, 0.43-2.82) but it was among older patients (age 65-74 years: HR, 3.18; 95% CI, 1.44-7.01; age ≥75 years: HR, 6.55; 95% CI, 1.46-29.35).","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lowenstern', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'C Larry', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Alhanti', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Pellikka', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Nanna', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Rajendra H', 'Initials': 'RH', 'LastName': 'Mehta', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Renee P', 'Initials': 'RP', 'LastName': 'Bullock-Palmer', 'Affiliation': 'Deborah Heart and Lung Center, Browns Mills, New Jersey.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Hoffmann', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2019.4973']
3084,31876900,Efficacy and Safety of Multiple Dupilumab Dose Regimens After Initial Successful Treatment in Patients With Atopic Dermatitis: A Randomized Clinical Trial.,"Importance


The dupilumab regimen of 300 mg every 2 weeks is approved for uncontrolled, moderate to severe atopic dermatitis (AD).
Objective


To assess the efficacy and safety of different dupilumab regimens in maintaining response after 16 weeks of initial treatment.
Design, Setting, and Participants


The Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (LIBERTY AD SOLO-CONTINUE) was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016, at 185 sites in North America, Europe, Asia, and Japan. Patients with moderate to severe AD who received dupilumab treatment and achieved an Investigator's Global Assessment score of 0 or 1 or 75% improvement in Eczema Area and Severity Index scores (EASI-75) at week 16 in 2 previous dupilumab monotherapy trials (LIBERTY AD SOLO 1 and 2) were rerandomized in SOLO-CONTINUE. After completing SOLO-CONTINUE, patients were followed up for up to 12 weeks or enrolled in an open-label extension. Data were analyzed from December 5 to 12, 2016.
Interventions


High-responding patients treated with dupilumab in SOLO were rerandomized 2:1:1:1 to continue their original regimen of dupilumab, 300 mg, weekly or every 2 weeks or to receive dupilumab, 300 mg, every 4 or 8 weeks or placebo for 36 weeks.
Main Outcomes and Measures


Percentage change in EASI score from baseline during the SOLO-CONTINUE trial, percentage of patients with EASI-75 at week 36, and safety.
Results


Among the 422 patients (mean [SD] age, 38.2 [14.5] years; 227 [53.8%] male), continuing dupilumab treatment once weekly or every 2 weeks maintained optimal efficacy, with negligible change in percent EASI improvement from SOLO 1 and 2 baseline during the SOLO-CONTINUE trial (-0.06%; P < .001 vs placebo); percent change with the other regimens dose-dependently worsened (dupilumab every 4 weeks, -3.84%; dupilumab every 8 weeks, -6.84%; placebo, -21.67%). More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]). Overall adverse event incidences were 70.7% in the weekly or every 2 weeks group, 73.6% in the every 4 weeks group, 75.0% in the every 8 weeks group, and 81.7% in the placebo group. Treatment groups had similar conjunctivitis rates. Treatment-emergent antidrug antibody incidence was lower with more frequent dupilumab dose regimens (11.3% in the placebo group and 11.7%, 6.0%, 4.3%, and 1.2% in the dupilumab every 8 weeks, every 4 weeks, every 2 weeks, and weekly groups, respectively).
Conclusions and Relevance


In this trial, continued response over time was most consistently maintained with dupilumab administered weekly or every 2 weeks. Longer dosage intervals and placebo resulted in a diminution of response for both continuous and categorical end points. No new safety signals were observed. The approved regimen of 300 mg of dupilumab every 2 weeks is recommended for long-term treatment.
Trial Registration


ClinicalTrials.gov identifier: NCT02395133.",2020,More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]).,"['Adults With Atopic Dermatitis (LIBERTY AD SOLO-CONTINUE) was a randomized, double-blind, phase 3 clinical trial conducted from March 25, 2015, to October 18, 2016, at 185 sites in North America, Europe, Asia, and Japan', '422 patients (mean [SD] age, 38.2 [14.5] years; 227 [53.8%] male', 'uncontrolled, moderate to severe atopic dermatitis (AD', 'Patients with moderate to severe AD', 'Patients With Atopic Dermatitis', 'Interventions\n\n\nHigh-responding patients treated with dupilumab in SOLO']","['placebo', 'dupilumab regimens', 'dupilumab', 'Multiple Dupilumab Dose Regimens']","['efficacy and safety', 'Overall adverse event incidences', 'EASI-75 response', 'Eczema Area and Severity Index scores (EASI-75', 'conjunctivitis rates', 'Efficacy and Safety', 'EASI score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}]",422.0,0.348949,More patients taking dupilumab weekly or every 2 weeks (116 of 162 [71.6%]; P < .001 vs placebo) maintained EASI-75 response than those taking dupilumab every 4 weeks (49 of 84 [58.3%]) or every 8 weeks (45 of 82 [54.9%]) or those taking placebo (24 of 79 [30.4%]).,"[{'ForeName': 'Margitta', 'Initials': 'M', 'LastName': 'Worm', 'Affiliation': 'Division of Allergy and Immunology, Klinik für Dermatologie, Venerologie und Allergologie, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, Nice University Hospital, Nice, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Beissert', 'Affiliation': 'Klinik und Poliklinik für Dermatologie, Universitätsklinikum, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrándiz', 'Affiliation': 'Servicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Universidad Autónoma de Barcelona, Badalona, Spain.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': ""St John's Institute of Dermatology, Guys and St Thomas' Foundation Trust, King's College, London, United Kingdom.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Bolanle', 'Initials': 'B', 'LastName': 'Akinlade', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts.'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Staudinger', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Rajadhyaksha', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc, Tarrytown, New York.'}]",JAMA dermatology,['10.1001/jamadermatol.2019.3617']
3085,31738378,Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial.,"Importance


Undiagnosed HIV infection results in delayed access to treatment and increased transmission. Self-tests for HIV may increase awareness of infection among men who have sex with men (MSM).
Objective


To evaluate the effect of providing HIV self-tests on frequency of testing, diagnoses of HIV infection, and sexual risk behaviors.
Design, Setting, and Participants


This 12-month longitudinal, 2-group randomized clinical trial recruited MSM through online banner advertisements from March through August 2015. Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses. Participants completed quarterly online surveys. Telephone call notes and laboratory test results were included in the analysis, which was completed from August 2017 through December 2018.
Interventions


All participants had access to online web-based HIV testing resources and telephone counseling on request. Participants were randomized in a 1:1 ratio to the control group or a self-testing (ST) group, which received 4 HIV self-tests after completing the baseline survey with the option to replenish self-tests after completing quarterly surveys. At study completion, all participants were offered 2 self-tests and 1 dried blood spot collection kit.
Main Outcomes and Measures


Primary outcomes were HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections among participants in both groups and social network members who used the study HIV self-tests. Secondary outcomes included sex behaviors (eg, anal sex, serosorting).
Results


Of 2665 participants, the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment. Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys. More ST participants reported testing 3 or more times during the trial than control participants (777 of 1014 [76.6%] vs 215 of 977 [22.0%]; P < .01). The cumulative number of newly identified infections during the trial was twice as high in the ST participants as the control participants (25 of 1325 [1.9%] vs 11 of 1340 [0.8%]; P = .02), with the largest difference in HIV infections identified in the first 3 months (12 of 1325 [0.9%] vs 2 of 1340 [0.1%]; P < .01). The ST participants reported 34 newly identified infections among social network members who used the self-tests.
Conclusions and Relevance


Distribution of HIV self-tests provides a worthwhile mechanism to increase awareness of HIV infection and prevent transmission among MSM.
Trial Registration


ClinicalTrials.gov identifier: NCT02067039.",2020,"Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys.","['the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment', 'Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses', '2665 participants', 'Men', 'men who have sex with men (MSM', 'All participants had access to online web-based HIV testing resources and telephone counseling on request', 'Who Have Sex With Men']","['Internet-Distributed HIV Self-tests', 'control group or a self-testing (ST']","['HIV Diagnosis and Behavioral Outcomes', 'HIV infections', 'HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections', 'frequency of testing, diagnoses of HIV infection, and sexual risk behaviors', 'sex behaviors (eg, anal sex, serosorting', 'Retention rates', 'cumulative number of newly identified infections']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",2665.0,0.11062,"Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys.","[{'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Pollyanna R', 'Initials': 'PR', 'LastName': 'Chavez', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'S Michele', 'Initials': 'SM', 'LastName': 'Owen', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Purcell', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Mermin', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5222']
3086,31710345,Evaluation of a Palliative Care Program for Nursing Homes in 7 Countries: The PACE Cluster-Randomized Clinical Trial.,"Importance


High-quality evidence on how to improve palliative care in nursing homes is lacking.
Objective


To investigate the effect of the Palliative Care for Older People (PACE) Steps to Success Program on resident and staff outcomes.
Design, Setting, and Participants


A cluster-randomized clinical trial (2015-2017) in 78 nursing homes in 7 countries comparing PACE Steps to Success Program (intervention) with usual care (control). Randomization was stratified by country and median number of beds in each country in a 1:1 ratio.
Interventions


The PACE Steps to Success Program is a multicomponent intervention to integrate basic nonspecialist palliative care in nursing homes. Using a train-the-trainer approach, an external trainer supports staff in nursing homes to introduce a palliative care approach over the course of 1 year following a 6-steps program. The steps are (1) advance care planning with residents and family, (2) assessment, care planning, and review of needs and problems, (3) coordination of care via monthly multidisciplinary review meetings, (4) delivery of high-quality care focusing on pain and depression, (5) care in the last days of life, and (6) care after death.
Main Outcomes and Measures


The primary resident outcome was comfort in the last week of life measured after death by staff using the End-of-Life in Dementia Scale Comfort Assessment While Dying (EOLD-CAD; range, 14-42). The primary staff outcome was knowledge of palliative care reported by staff using the Palliative Care Survey (PCS; range, 0-1).
Results


Concerning deceased residents, we collected 551 of 610 questionnaires from staff at baseline and 984 of 1178 postintervention in 37 intervention and 36 control homes. Mean (SD) age at time of death ranged between 85.22 (9.13) and 85.91 (8.57) years, and between 60.6% (160/264) and 70.6% (190/269) of residents were women across the different groups. Residents' comfort in the last week of life did not differ between intervention and control groups (baseline-adjusted mean difference, -0.55; 95% CI, -1.71 to 0.61; P = .35). Concerning staff, we collected 2680 of 3638 questionnaires at baseline and 2437 of 3510 postintervention in 37 intervention and 38 control homes. Mean (SD) age of staff ranged between 42.3 (12.1) and 44.1 (11.7) years, and between 87.2% (1092/1253) and 89% (1224/1375) of staff were women across the different groups. Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001). Data analyses began on April 20, 2018.
Conclusions and Relevance


Residents' comfort in the last week of life did not improve after introducing the PACE Steps to Success Program. Improvements in staff knowledge of palliative care were clinically not important.
Trial Registration


ISRCTN Identifier: ISRCTN14741671.",2020,"Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001).","['Older People', 'deceased residents', 'Concerning staff, we collected 2680 of 3638 questionnaires at baseline and 2437 of 3510 postintervention in 37 intervention and 38 control homes', 'collected 551 of 610 questionnaires from staff at baseline and 984 of 1178 postintervention in 37 intervention and 36 control homes', '78 nursing homes in 7 countries comparing', 'Nursing Homes in 7 Countries']","['care via monthly multidisciplinary review meetings, (4) delivery of high-quality care focusing on pain and depression, (5) care in the last days of life, and (6) care after death', 'PACE Steps to Success Program (intervention) with usual care (control', 'external trainer supports staff', 'Palliative Care', 'Palliative Care Program']","['Mean (SD) age of staff', 'comfort in the last week of life measured after death by staff using the End-of-Life in Dementia Scale Comfort Assessment While Dying (EOLD-CAD', 'knowledge of palliative care', 'Mean (SD) age at time of death', 'knowledge of palliative care reported by staff using the Palliative Care Survey (PCS; range, 0-1']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C3872828', 'cui_str': 'Multidisciplinary review'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",1178.0,0.111688,"Staff in the intervention group had statistically significantly better knowledge of palliative care than staff in the control group, but the clinical difference was minimal (baseline-adjusted mean difference, 0.04; 95% CI, 0.02-0.05; P < .001).","[{'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Honinx', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pivodic', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Miranda', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Bregje D', 'Initials': 'BD', 'LastName': 'Onwuteaka-Philipsen', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'van Hout', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of General Practice and Elderly Care Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'H Roeline W', 'Initials': 'HRW', 'LastName': 'Pasman', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Oosterveld-Vlug', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Ten Koppel', 'Affiliation': 'Amsterdam Public Health Research Institute, Expertise Center for Palliative Care, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Piers', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Van Den Noortgate', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Engels', 'Affiliation': 'Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Myrra', 'Initials': 'M', 'LastName': 'Vernooij-Dassen', 'Affiliation': 'IQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Hockley', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Froggatt', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Payne', 'Affiliation': 'International Observatory on End-of-Life Care, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbinska', 'Affiliation': 'Unit for Research on Aging Society, Department of Sociology of Medicine, Epidemiology and Preventive Medicine Chair, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Hôpitaux Universitaires de Genève, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bassal', 'Affiliation': 'Center for the Interdisciplinary Study of Gerontology and Vulnerability (CIGEV), University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Buysser', 'Affiliation': 'Biostatistics Unit, Faculty of Medicine and Health Sciences, Ghent University, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'VUB-UGhent End-of-Life Care Research Group, Ghent University and Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5349']
3087,31669091,Tolerability and efficacy of the concentration of iodine solution during esophageal chromoendoscopy: a double-blind randomized controlled trial.,"BACKGROUND AND AIMS


Esophageal chromoendoscopy with iodine solution is an important diagnostic method for the detection of superficial esophageal cancer. However, the concentration of iodine solution has differed among reports. This study aimed to evaluate patient discomfort with different iodine concentrations.
METHODS


We performed a prospective, double-blind, randomized study. We prospectively enrolled and analyzed 77 patients who were at high risk for esophageal carcinoma and scheduled to undergo EGD from March 2018 to January 2019. All patients were divided into 2 groups before the procedure to compare pain measurements: a 1% iodine solution group (group A) and a 2% iodine solution group (group B). The primary endpoint of this study was the difference in pain measurement between 1% and 2% iodine solution chromoendoscopy. Secondary endpoints were safety, detection yield, and color evaluation based on both the endoscopist's survey and color values, as determined using the Commission Internationale de l'Eclairage (CIELAB, Vienna, Austria) color evaluation system, in the iodine-faded and iodine-stained area of each group.
RESULTS


Heartburn and retrosternal pain in group A were significantly lower than those in group B (P = .02). Eleven patients reported heartburn and retrosternal pain (group A, 2; group B, 9). Four patients reported pain above the sternal angle and 7 below the sternal angle. There was no significant difference between the 2 groups with regard to detection yield, color evaluation by the endoscopist's assessment, or color values. No patients had any adverse events, and all safely completed this study.
CONCLUSIONS


The 2% iodine solution resulted in significantly greater pain than the 1% iodine solution, and the color of the stained esophageal images of each group was the same from this study. Therefore, the 1% iodine solution is recommended for esophageal chromoendoscopy. (Clinical trial registration number: UMIN 000029796.).",2020,"There was no significant difference between the 2 groups with regard to the detection yield, color evaluation by the endoscopist's assessment or the color values.","['77 patients who were at high risk for esophageal carcinoma and scheduled to undergo esophagogastroduodenoscopy from March 2018 to January 2019', ""patients' discomfort with different iodine concentrations"", 'superficial esophageal cancer']","['iodine solution', 'iodine solution group (Group A) and a 2% iodine solution']","['pain above the sternal angle', 'Tolerability and efficacy', 'pain measurement', 'adverse events', 'pain', 'heartburn and retrosternal pain', 'concentration of iodine solution', ""safety, detection yield, and color evaluation based on both the endoscopist's survey and color values, as determined using the CIELAB color evaluation system, in the iodine-faded and iodine-stained area of each group""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0152018', 'cui_str': 'Carcinoma of esophagus (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0301299', 'cui_str': 'Iodine solution (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222772', 'cui_str': 'Structure of sternal angle'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0151826', 'cui_str': 'Retrosternal pain (finding)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0301299', 'cui_str': 'Iodine solution (substance)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",,0.149237,"There was no significant difference between the 2 groups with regard to the detection yield, color evaluation by the endoscopist's assessment or the color values.","[{'ForeName': 'Tatsuhiro', 'Initials': 'T', 'LastName': 'Gotoda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Kanzaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Obayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Hamada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sakae', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Iwamuro', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kawano', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Kawahara', 'Affiliation': 'Department of Endoscopy, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Department of Endoscopy, Okayama University Hospital, Okayama, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2019.10.022']
3088,32202637,Clinical and biological implications of target occupancy in CLL treated with the BTK inhibitor acalabrutinib.,"Inhibition of the B-cell receptor pathway, and specifically of Bruton tyrosine kinase (BTK), is a leading therapeutic strategy in B-cell malignancies, including chronic lymphocytic leukemia (CLL). Target occupancy is a measure of covalent binding to BTK and has been applied as a pharmacodynamic parameter in clinical studies of BTK inhibitors. However, the kinetics of de novo BTK synthesis, which determines occupancy, and the relationship between occupancy, pathway inhibition and clinical outcomes remain undefined. This randomized phase 2 study investigated the safety, efficacy, and pharmacodynamics of a selective BTK inhibitor acalabrutinib at 100 mg twice daily (BID) or 200 mg once daily (QD) in 48 patients with relapsed/refractory or high-risk treatment-naïve CLL. Acalabrutinib was well tolerated and yielded an overall response rate (ORR) of partial response or better of 95.8% (95% confidence interval [CI], 78.9-99.9) and an estimated progression-free survival (PFS) rate at 24 months of 91.5% (95% CI, 70.0-97.8) with BID dosing and an ORR of 79.2% (95% CI, 57.9-92.9) and an estimated PFS rate at 24 months of 87.2% (95% CI, 57.2-96.7) with QD dosing. BTK resynthesis was faster in patients with CLL than in healthy volunteers. BID dosing maintained higher BTK occupancy and achieved more potent pathway inhibition compared with QD dosing. Small increments in occupancy attained by BID dosing relative to QD dosing compounded over time to augment downstream biological effects. The impact of BTK occupancy on long-term clinical outcomes remains to be determined. This trial was registered at www.clinicaltrials.gov as #NCT02337829.",2020,"Acalabrutinib was well tolerated and yielded an overall response rate (ORR) of partial response or better of 95.8% (95% CI 78.9%, 99.9%) and an estimated progression-free survival (PFS) rate at 24 months of 91.5% (95% CI 70.0%, 97.8%) with BID dosing and an ORR of 79.2% (95% CI 57.9%, 92.9%) and an estimated PFS rate at 24 months of 87.2% (95% CI 57.2%, 96.7%) with QD dosing.","['healthy volunteers', 'chronic lymphocytic leukemia (CLL', '48 patients with relapsed/refractory or high-risk treatment naïve CLL']",['selective BTK inhibitor acalabrutinib'],"['safety, efficacy, and pharmacodynamics', 'estimated progression-free survival (PFS) rate', 'overall response rate (ORR) of partial response', 'estimated PFS rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",48.0,0.0640529,"Acalabrutinib was well tolerated and yielded an overall response rate (ORR) of partial response or better of 95.8% (95% CI 78.9%, 99.9%) and an estimated progression-free survival (PFS) rate at 24 months of 91.5% (95% CI 70.0%, 97.8%) with BID dosing and an ORR of 79.2% (95% CI 57.9%, 92.9%) and an estimated PFS rate at 24 months of 87.2% (95% CI 57.2%, 96.7%) with QD dosing.","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nierman', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Ellen K', 'Initials': 'EK', 'LastName': 'Kendall', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Cheung', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gulrajani', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Sarah E M', 'Initials': 'SEM', 'LastName': 'Herman', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pleyer', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Inhye E', 'Initials': 'IE', 'LastName': 'Ahn', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Maryalice', 'Initials': 'M', 'LastName': 'Stetler-Stevenson', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, and.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Yuan', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, and.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Maric', 'Affiliation': 'Hematology Section, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD; and.'}, {'ForeName': 'Erika M', 'Initials': 'EM', 'LastName': 'Gaglione', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Hailey M', 'Initials': 'HM', 'LastName': 'Harris', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pittaluga', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, and.'}, {'ForeName': 'Min Hui', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hamdy', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Covey', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wiestner', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}]",Blood,['10.1182/blood.2019003715']
3089,31917441,Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease: A Randomized Clinical Trial.,"Importance


Although the Canadian Treat-and-Extend Analysis Trial With Ranibizumab in Patients With Neovascular Age-Related Macular Disease (CANTREAT) reported herein and the Treat and Extend study provided data to show noninferiority of treat-and-extend (T&E) at 12 months, to date there are few data on 24-month T&E trials compared with monthly dosing.
Objective


To compare the efficacy of ranibizumab using a T&E regimen to monthly dosing in treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months.
Design, Setting, and Participants


A randomized, open-label, multicenter, noninferiority intention-to-treat trial with a margin of -5 letters in best-corrected visual acuity (BCVA) from baseline to 12 months between groups was conducted at 27 treatment centers in Canada. Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD. The study was conducted from May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018.
Interventions


Patients with nAMD were randomized 1:1 to receive intravitreal ranibizumab, 0.5 mg, in either a T&E or monthly dosing regimen.
Main Outcomes and Measures


Mean change in BCVA in Early Treatment of Diabetic Retinopathy Study letters from baseline to month 24.
Results


Of the 580 randomized patients, 350 were women (60.3%) and 547 were white (94.3%). Mean (SD) age was 78.8 (7.8) years. By the end of month 24, 466 of the 580 randomized patients (80.3%) had completed the study and participants in the T&E arm received a mean of 17.6 injections compared with 23.5 injections for the monthly arm, for a difference of 5.9 injections and visits over 2 years (95% CI, 5.4-6.5; P < .001). The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21). There was a gain of 15 or more letters in 25.5% of the T&E group and 23.1% of the monthly treatment group (difference, 2.4%; 95% CI, -6.8% to 11.6%; P = .59) and a loss of 15 or more letters in 6.5% of the T&E group and 5.8% of the monthly treatment group (difference, -0.7%; 95% CI, -9.9% to 8.5%; P = .85).
Conclusions and Relevance


These findings suggest that change in vision from baseline is not worse with a T&E compared with a monthly regimen of ranibizumab for nAMD through 24 months, achieving clinically meaningful improvements in BCVA despite fewer injections and visits.
Trial Registration


ClinicalTrials.gov identifier: NCT02103738.",2020,"The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21).","['580 randomized patients', 'Participants included 580 patients with treatment-naive choroidal neovascularization secondary to AMD', 'treatment-naive patients with neovascular age-related macular degeneration (nAMD) after 24 months', '350 were women (60.3%) and 547 were white (94.3', 'Mean (SD) age was 78.8 (7.8) years', 'Patients With Neovascular Age-Related Macular Disease (CANTREAT', 'Patients With Neovascular Age-Related Macular Disease', 'Interventions\n\n\nPatients with nAMD', 'May 8, 2013, to August 28, 2018, and data analysis was performed between August 29 and September 12, 2018']","['T&E or monthly dosing regimen', 'ranibizumab', 'Ranibizumab', 'Treat-and-Extend Regimen With Ranibizumab', 'intravitreal ranibizumab']","['gain of 15 or more letters', 'mean (SD) BCVA improvement']","[{'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600518', 'cui_str': 'Neovascularization, Choroid'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0730362', 'cui_str': 'Maculopathy'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",580.0,0.338271,"The mean (SD) BCVA improvement was not worse with the T&E arm, 6.8 (14.1) letters vs 6.0 (12.6) letters, compared with the monthly arm (difference, 0.9; 95% CI, -1.6 to 3.3; P = .21).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kertes', 'Affiliation': 'The John and Liz Tory Eye Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Ivan J', 'Initials': 'IJ', 'LastName': 'Galic', 'Affiliation': 'Montreal Retina Institute, Montreal, Québec, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Greve', 'Affiliation': 'Alberta Retina Consultants, Edmonton, Alberta, Canada.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Williams', 'Affiliation': 'Calgary Retina Consultants, Calgary, Alberta, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, Québec, Canada.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Lahaie', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, Québec, Canada.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Sheidow', 'Affiliation': 'Ivey Eye Institute, London, Ontario, Canada.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.5540']
3090,30796338,Home-based Aerobic Exercise and Resistance Training in Peritoneal Dialysis Patients: A Randomized Controlled Trial.,"Potential effects of aerobic and resistance training in peritoneal dialysis (PD) patients have been partially elucidated. We investigated effects of a home-based exercise program on physical functioning and health-related quality of life (HRQOL) in PD patients. Patients were randomly assigned to exercise (n = 24) and usual care (n = 23) groups. The exercise patients performed aerobic exercise thrice weekly and resistance training twice weekly at home for 12 weeks. The usual care patients received no specific intervention. The distance in incremental shuttle walking test significantly improved in the exercise group compared with the usual care group (P = 0.02). Among the HRQOL subscales assessed using the Kidney Disease Quality of Life-Short Form questionnaire, kidney disease component summary (P = 0.03), physical role functioning (P = 0.01), emotional role functioning (P < 0.01), and role/social component summary (P < 0.01) significantly improved in the exercise group. Moreover, serum albumin was significantly maintained in the exercise group (P = 0.03). There were no reported adverse events associated with the intervention. To our knowledge, this is the first randomized controlled trial to indicate the beneficial effects of a 12-week home-based exercise program exclusively in PD patients.",2019,The distance in incremental shuttle walking test significantly improved in the exercise group compared with the usual care group (P = 0.02).,"['Peritoneal Dialysis Patients', 'PD patients', 'peritoneal dialysis (PD) patients']","['home-based exercise program', 'aerobic exercise thrice weekly and resistance training', 'Home-based Aerobic Exercise and Resistance Training', 'aerobic and resistance training', 'no specific intervention']","['Kidney Disease Quality of Life-Short Form questionnaire, kidney disease component summary', 'serum albumin', 'role/social component summary', 'adverse events', 'emotional role functioning', 'distance in incremental shuttle walking test', 'physical functioning and health-related quality of life (HRQOL', 'physical role functioning']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.0359903,The distance in incremental shuttle walking test significantly improved in the exercise group compared with the usual care group (P = 0.02).,"[{'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Uchiyama', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. kiyo.0817.piyo@gmail.com.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Washida', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kohkichi', 'Initials': 'K', 'LastName': 'Morimoto', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Muraoka', 'Affiliation': 'Department of Rehabilitation Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kasai', 'Affiliation': 'Department of Nephrology, International University of Health and Welfare School of Medicine, 4-3, Kozunomori, Narita, Chiba, 286-8686, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamaki', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Kazutoshi', 'Initials': 'K', 'LastName': 'Miyashita', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Wakino', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.'}]",Scientific reports,['10.1038/s41598-019-39074-9']
3091,31811673,Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Low Back Pain: An Emergency Department-based Randomized Study.,"OBJECTIVES


Patients with low back pain (LBP) are often treated with nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are modestly effective for LBP, but many patients with LBP continue to suffer despite treatment with these medications. We compared pain and functional outcomes 1 week after emergency department (ED) discharge among patients randomized to a 1-week course of ibuprofen plus acetaminophen versus ibuprofen plus placebo.
METHODS


This was a randomized, double-blind study conducted in two urban EDs. Patients presenting with acute, nontraumatic, nonradicular LBP of no more than 2 weeks' duration were eligible for enrollment immediately prior to discharge from an ED if they had a score > 5 on the Roland Morris Disability Questionnaire (RMDQ), a 24-item validated instrument, indicating more than minimal functional impairment. All patients were given a standardized 10-minute LBP educational session prior to discharge. The primary outcome was improvement on the RMDQ between ED discharge and 1 week later. One secondary outcome was pain intensity, as measured on a 4-point descriptive scale (severe, moderate, mild, none) at 1 week.
RESULTS


Enrollment began in October 2018. A total of 120 patients met selection criteria and were randomized. Baseline demographic characteristics were comparable between the two groups. By 1 week after the ED visit, patients randomized to ibuprofen plus placebo reported a mean (±SD) improvement in the RMDQ of 11.9 (±9.7), while those randomized to ibuprofen plus acetaminophen reported a mean (±SD) improvement of 11.1 (±10.7). The 95% CI for the between-group difference of 0.8 was -3.0 to 4.7. At 1 week, moderate or severe pain was reported by 15 of 53 (28%) patients in the ibuprofen plus placebo group and 16 of 57 (28%) patients in the ibuprofen plus acetaminophen group (95% CI for between-group difference of 0% = -17% to 17%).
CONCLUSION


Among ED patients with acute, nontraumatic, nonradicular LBP, adding acetaminophen to ibuprofen does not improve outcomes within 1 week.",2020,"At 1 week, moderate or severe pain was reported by 15 of 53 (28%) patients in the ibuprofen plus placebo group and 16 of 57 (28%) patients in the ibuprofen plus acetaminophen group (95% CI for between-group difference of 0% =","['Patients with low back pain (LBP', '120 patients met selection criteria and were randomized', ""Patients presenting with acute, nontraumatic, nonradicular LBP of no more than 2\xa0weeks' duration were eligible for enrollment immediately prior to discharge from an ED if they had a score\xa0>\xa05 on the Roland Morris Disability Questionnaire (RMDQ), a 24-item validated instrument, indicating more than minimal functional impairment"", 'Acute Low Back Pain', 'two urban EDs']","['standardized 10-minute LBP educational session', 'Ibuprofen Alone', 'acetaminophen to ibuprofen', 'Ibuprofen Plus Acetaminophen', 'nonsteroidal anti-inflammatory drugs (NSAIDs', 'ibuprofen plus placebo', 'ibuprofen plus acetaminophen']","['pain intensity, as measured on a 4-point descriptive scale (severe, moderate, mild, none', 'Baseline demographic characteristics', 'RMDQ between ED discharge and 1 week later', 'moderate or severe pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205172', 'cui_str': 'More (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain (finding)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",120.0,0.495752,"At 1 week, moderate or severe pain was reported by 15 of 53 (28%) patients in the ibuprofen plus placebo group and 16 of 57 (28%) patients in the ibuprofen plus acetaminophen group (95% CI for between-group difference of 0% =","[{'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Irizarry', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Chertoff', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Feliciano', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Clemencia', 'Initials': 'C', 'LastName': 'Solorzano', 'Affiliation': 'and the, Department of Pharmacy, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Zias', 'Affiliation': 'and the, Department of Pharmacy, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Gallagher', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13898']
3092,32008847,Routine exercise-based cardiac rehabilitation does not increase aerobic fitness: A CARE CR study.,"BACKGROUND


Recent evidence suggests that routine exercise-based cardiac rehabilitation (CR) may not lead to a substantial increase in estimated peak oxygen uptake (V̇O 2peak ). This could reduce the potential benefits of CR and explain why CR no longer improves patient survival in recent studies. We aimed to determine whether routine exercise-based CR increases V̇O 2peak  using gold-standard maximal cardiopulmonary exercise testing (CPET), and to quantify the exercise training stimulus which might be insufficient in patients undertaking CR.
METHODS


We studied the effects of a routine, twice weekly, exercise-based CR programme for eight weeks (intervention group) compared with abstention from supervised exercise training (control group) in patients with coronary heart disease. The primary outcome was V̇O 2peak  measured using CPET. We also measured changes in body composition using dual X-ray absorptiometry, carotid intima-media thickness, hs-CRP and N-terminal pro B-type natriuretic peptide at baseline, 10 weeks and 12 months. We also calculated the Calibre 5-year all-cause mortality risk score.
RESULTS


Seventy patients (age 63.1 SD10.0 years; BMI 29.2 SD4.0 kg·m -2 ; 86% male) were recruited (n = 48 intervention; n = 22 controls). The mean aerobic exercise training duration was 23 min per training session, and the mean exercise training intensity was 45.9% of heart rate reserve. V̇O 2peak  was 23·3 ml·kg -1 ·min -1  at baseline, and there were no changes in V̇O 2peak  between groups at any time point. The intervention had no effect on any of the secondary endpoints.
CONCLUSION


Routine CR does not lead to an increase in V̇O 2peak  and is unlikely to improve long-term physiological outcomes.",2020,"CONCLUSION


Routine CR does not lead to an increase in V̇O 2peak  and is unlikely to improve long-term physiological outcomes.","['patients undertaking CR', 'patients with coronary heart disease', 'Seventy patients (age 63.1 SD10.0\xa0years']","['exercise-based CR programme for eight weeks (intervention group) compared with abstention from supervised exercise training (control group', 'routine exercise-based CR increases V̇O 2peak  using gold-standard maximal cardiopulmonary exercise testing (CPET', 'Routine exercise-based cardiac rehabilitation', 'routine exercise-based cardiac rehabilitation (CR']","['body composition using dual X-ray absorptiometry, carotid intima-media thickness, hs-CRP and N-terminal pro B-type natriuretic peptide', 'V̇O 2peak', 'mean aerobic exercise training duration', 'V̇O 2peak  measured using CPET', 'aerobic fitness', 'patient survival', 'mean exercise training intensity', 'Calibre 5-year all-cause mortality risk score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",86.0,0.153767,"CONCLUSION


Routine CR does not lead to an increase in V̇O 2peak  and is unlikely to improve long-term physiological outcomes.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nichols', 'Affiliation': 'Centre for Sports and Exercise Science, Sheffield Hallam University, Collegiate Campus, Sheffield S10 2BP, United Kingdom. Electronic address: s.j.nichols@shu.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: claire@hewison.net.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goodman', 'Affiliation': 'City Health Care Partnership CIC, East Riding Community Hospital, Swinemoore Lane, Beverley HU17 0FA, United Kingdom. Electronic address: toni.goodman@nhs.net.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: r.page@hull.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kallvikbacka-Bennett', 'Affiliation': 'Academic Cardiology Castle Hill Hospital, Hull and East Yorkshire Hospitals, Castle Road, Cottingham HU16 5JQ, United Kingdom. Electronic address: Anna.Bennett@hey.nhs.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nation', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: f.nation@hull.ac.uk.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Academic Cardiology Castle Hill Hospital, Hull and East Yorkshire Hospitals, Castle Road, Cottingham HU16 5JQ, United Kingdom. Electronic address: A.L.Clark@hull.ac.uk.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Birkett', 'Affiliation': 'School of Sport and Health Sciences, University of Central Lancashire, Preston, PR1 2HE, United Kingdom. Electronic address: SBirkett4@uclan.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: s.carroll@hull.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ingle', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: l.ingle@hull.ac.uk.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.044']
3093,31556911,Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial.,"Importance


Standard adverse event (AE) reporting in oncology clinical trials has historically relied on clinician grading, which prior research has shown can lead to underestimation of rates of symptomatic AEs. Industry sponsors are beginning to implement in trials the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which was developed to allow patients to self-report symptomatic AEs and improve the quality of symptomatic AE detection.
Objectives


To evaluate the feasibility of implementing PRO-CTCAE in a prespecified correlative analysis of the phase 3 COMET-2 trial and enumerate statistically significant between-group differences in symptomatic AEs using PRO-CTCAE and the CTCAE.
Design, Setting, and Participants


This correlative study of 119 men in the randomized, double-blind, placebo-controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014. Participants completed PRO-CTCAE items using an automated telephone system from home prior to treatment and every 3 weeks during treatment. Statistical analysis was performed from May 2018 to June 2019.
Main Outcomes and Measures


The proportion of patients who completed expected PRO-CTCAE self-reports was computed as a measure of feasibility.
Results


Among the 119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports were completed, with consistently high rates of completion throughout participation. Rates of self-report adherence were similar between groups (cabozantinib s-maleate, 286 of 317 [90.2%]; and mitoxantrone hydrochloride-prednisone, 248 of 270 [91.9%]). Of 12 measured, patient-reported PRO-CTCAE symptomatic AEs, 4 reached statistical significance when comparing the proportion of patients with at least 1 postbaseline score greater than 0 between groups (differences ranged from 20.1% to 34.1% with higher proportions in the cabozantinib group; all P < .05), and use of a method for accounting for preexisting symptoms at baseline yielded 7 AEs with statistically significant differences between groups (differences ranged from 20.5% to 41.2% with higher proportions in the cabozantinib group; all P < .05). In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs.
Conclusions and Relevance


PRO-CTCAE data collection was feasible and improved the accuracy of symptomatic AE detection in a phase 3 cancer trial. This analysis adds to mounting evidence of the feasibility and value of patient-reported AEs in oncology, which should be considered for inclusion in cancer trials that incorporate AE evaluation.
Trial Registration


ClinicalTrials.gov identifier: NCT01522443.",2020,"In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs.
","['119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports', '119 men', 'controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014']","['placebo', 'mitoxantrone hydrochloride-prednisone']",['Rates of self-report adherence'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0282670', 'cui_str': 'Comets (Astronomy)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0700458', 'cui_str': 'Mitoxantrone Hydrochloride'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",119.0,0.207639,"In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs.
","[{'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Department of Medicine, Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Antonia V', 'Initials': 'AV', 'LastName': 'Bennett', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Gina L', 'Initials': 'GL', 'LastName': 'Mazza', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Schwab', 'Affiliation': 'Exelixis Inc, South San Francisco, California.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Weitzman', 'Affiliation': 'Independent Consultant, San Francisco, California.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Rogak', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Basch', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.'}]",JAMA oncology,['10.1001/jamaoncol.2019.3332']
3094,31841577,Acyclovir for Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation: A Randomized Clinical Trial.,"Importance


The role of herpes simplex virus (HSV) reactivation on morbidity and mortality in patients in the intensive care unit requiring mechanical ventilation remains unknown.
Objective


To determine whether preemptive treatment with intravenous acyclovir reduces the duration of mechanical ventilation in patients with HSV oropharyngeal reactivation.
Design, Setting, and Participants


A double-blind, placebo-controlled randomized clinical trial was conducted in 16 intensive care units in France. Participants included 239 adults (age, >18 years) who received mechanical ventilation for at least 96 hours and continued to receive mechanical ventilation for 48 hours or more, with HSV oropharyngeal reactivation. Patients were enrolled between February 2, 2014, and February 22, 2018.
Interventions


Participants were randomized to receive intravenous acyclovir, 5 mg/kg, 3 times daily for 14 days or a matching placebo.
Main Outcomes and Measures


The primary end point was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included mortality at 60 days. Main analyses were conducted on an intention-to-treat basis.
Results


Of 239 patients enrolled and randomized, 1 patient withdrew consent, leaving 238 patients, with 119 patients in both the acyclovir and placebo (control) groups (median [IQR] age, 61 [50-70] years; 76 [32%] women) available for primary outcome measurement. On day 60, the median (IQR) numbers of ventilator-free days were 35 (0-53) for acyclovir recipients and 36 (0-50]) for controls (P = .17 for between-group comparison). Among secondary outcomes, 26 patients (22%) and 39 patients (33%) had died at day 60 (risk difference, 0.11, 95% CI, -0.004 to 0.22, P = .06). The adverse event frequency was similar for both groups (28% in the acyclovir group and 23% in the placebo group, P = .40), particularly acute renal failure post randomization affecting 3 acyclovir recipients (3%) and 2 controls (2%). Four patients (3%) in the acyclovir group vs none in the placebo group stopped the study drug for treatment-related adverse events.
Conclusions and Relevance


In patients receiving mechanical ventilation for 96 hours or more with HSV reactivation in the throat, use of acyclovir, 5 mg/kg, 3 times daily for 14 days, did not increase the number of ventilator-free days at day 60, compared with placebo. These findings do not appear to support routine preemptive use of acyclovir in this setting.
Trial Registration


ClinicalTrials.gov identifier: NCT02152358.",2020,"The adverse event frequency was similar for both groups (28% in the acyclovir group and 23% in the placebo group, P = .40), particularly acute renal failure post randomization affecting 3 acyclovir recipients (3%) and 2 controls (2%).","['16 intensive care units in France', 'control) groups (median [IQR] age, 61 [50-70] years; 76 [32%] women) available for primary outcome measurement', 'patients with HSV oropharyngeal reactivation', 'Participants included 239 adults (age, >18 years) who received', 'for 48 hours or more, with HSV oropharyngeal reactivation', 'Patients were enrolled between February 2, 2014, and February 22, 2018', '239 patients enrolled and randomized, 1 patient withdrew consent, leaving 238 patients, with 119 patients in both the', 'patients in the intensive care unit requiring mechanical ventilation remains unknown', 'Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation']","['herpes simplex virus (HSV) reactivation', 'acyclovir', 'acyclovir and placebo', 'mechanical ventilation for at least 96 hours and continued to receive mechanical ventilation', 'placebo', 'Acyclovir', 'intravenous acyclovir', 'mechanical ventilation']","['acute renal failure', 'number of ventilator-free days', 'mortality', 'duration of mechanical ventilation', 'morbidity and mortality', 'adverse event frequency', 'median (IQR) numbers of ventilator-free days']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0001367', 'cui_str': 'Acyclovir'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C3854173', 'cui_str': 'Pre-renal acute kidney injury'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",239.0,0.632809,"The adverse event frequency was similar for both groups (28% in the acyclovir group and 23% in the placebo group, P = .40), particularly acute renal failure post randomization affecting 3 acyclovir recipients (3%) and 2 controls (2%).","[{'ForeName': 'Charles-Edouard', 'Initials': 'CE', 'LastName': 'Luyt', 'Affiliation': 'Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Forel', 'Affiliation': 'Médecine Intensive Réanimation, Aix-Marseille Université, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie, Paris, France.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Réanimation Chirurgicale, Centre Hospitalier Universitaire de Montpellier, Hôpital St-Eloi, Montpellier, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cayot-Constantin', 'Affiliation': 'Département de médecine periopératoire, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmelé', 'Affiliation': 'Réanimation Chirurgicale, Hôpital Edouard-Herriot, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Coupez', 'Affiliation': 'Réanimation Médicale, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': ""Réanimation Chirurgicale Polyvalente, Département d'Anesthésie-Réanimation, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Mamadou Hassimiou', 'Initials': 'MH', 'LastName': 'Diallo', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière Charles Foix, Unité de Recherche Clinique, Paris, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Penot-Ragon', 'Affiliation': 'Pharmacie, Hôpitaux Sud, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clavel', 'Affiliation': 'Réanimation Polyvalente, Centre Hospitalier Universitaire Dupuytren, Limoges, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Schwebel', 'Affiliation': 'Médecine Intensive Réanimation, Centre Hospitalier Universitaire Grenoble Alpes, La Tronche, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Bedos', 'Affiliation': 'Service de Réanimation, Hôpital Mignot, Versailles, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hauw-Berlemont', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jérémy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Réanimation des Urgences et Médicale, Aix-Marseille Université, Hôpital Timone, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mayaux', 'Affiliation': 'Pneumologie, Médecine Intensive Réanimation, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Réanimation Chirurgicale, Centre Hospitalier Universitaire Nîmes, Nîmes, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Médecine Intensive Réanimation, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Combes', 'Affiliation': 'Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Réanimation Neurochirurgicale, Hôpital Sainte-Anne, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Chastre', 'Affiliation': 'Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Papazian', 'Affiliation': 'Médecine Intensive Réanimation, Aix-Marseille Université, Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA internal medicine,['10.1001/jamainternmed.2019.5713']
3095,31272977,An Application-based programme to reinforce and maintain lower salt intake (AppSalt) in schoolchildren and their families in China.,"INTRODUCTION


Salt intake is very high in China, with ≈80% being added by the consumers. It is difficult to reduce salt in such settings. Our previous study (School-based Education programme to reduce Salt(School-EduSalt)) demonstrated that educating schoolchildren, who then instructed their families to reduce the amount of salt used at home, is effective in lowering salt intake in both children and adults. Our team also developed an app called 'KnowSalt', which could help individuals to estimate their salt intake and the major sources of salt in the diet. Building on School-EduSalt and KnowSalt, we propose to develop a new app (AppSalt) focusing on salt reduction through education, target setting, monitoring, evaluation, decision support and management to achieve a progressive lower salt intake for long term. To evaluate the effectiveness of the AppSalt programme, we will carry out a cluster randomised controlled trial.
METHODS AND ANALYSIS


We will recruit 54 primary schools from urban and rural areas of three provinces in China. A total of 594 children aged 8-9 years and 1188 adult family members will be randomly selected for evaluation. After baseline assessment, schools will be randomly allocated to either the intervention or control group. Children in the intervention group will be taught, with support of AppSalt, about salt reduction and assigned homework to get the whole family involved in the activities to reduce salt consumption. The duration of the intervention is two school terms (ie, 1 year). The primary outcome is the difference between the intervention and control group in the change of salt intake as measured by 24-hour urinary sodium.
ETHICS AND DISSEMINATION


The study has been approved by Queen Mary Research Ethics Committee and Peking University Health Science Centre IRB. Results will be disseminated through presentations, publications and social media.
TRIAL REGISTRATION NUMBER


ChiCTR1800017553.",2019,"Our team also developed an app called 'KnowSalt', which could help individuals to estimate their salt intake and the major sources of salt in the diet.","['594 children aged 8-9 years and 1188 adult family members', 'schoolchildren and their families in China', '54 primary schools from urban and rural areas of three provinces in China']",['AppSalt programme'],['change of salt intake as measured by 24-hour urinary sodium'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]",594.0,0.0438188,"Our team also developed an app called 'KnowSalt', which could help individuals to estimate their salt intake and the major sources of salt in the diet.","[{'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London Scho ol of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Fengge', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Changan Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Shijiazhuang Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Daoxi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Luzhou Center for Disease Control and Prevention, Luzhou, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Luzhou Center for Disease Control and Prevention, Luzhou, China.'}, {'ForeName': 'Tianyong', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Luzhou Center for Disease Control and Prevention, Luzhou, China.'}, {'ForeName': 'Jianyun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Yueyang Center for Disease Control and Prevention, Yueyang, China.'}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Yueyang Center for Disease Control and Prevention, Yueyang, China.'}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Yueyang Center for Disease Control and Prevention, Yueyang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Computing, Beihang University, Beijing, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Changqiong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London Scho ol of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London Scho ol of Medicine & Dentistry, Queen Mary University of London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027793']
3096,31352415,Early medical therapy for acute laryngeal injury (ALgI) following endotracheal intubation: a protocol for a prospective single-centre randomised controlled trial.,"INTRODUCTION


Respiratory failure requiring endotracheal intubation accounts for a significant proportion of intensive care unit (ICU) admissions. Little attention has been paid to the laryngeal consequences of endotracheal intubation. Acute laryngeal injury (ALgI) after intubation occurs at the mucosal interface of the endotracheal tube and posterior larynx and although not immediately manifest at extubation, can progress to mature fibrosis, restricted glottic mobility and clinically significant ventilatory impairment. A recent prospective observational study has shown that >50% of patients intubated >24 hours in an ICU develop ALgI. Strikingly, patients with AlgI manifest significantly worse subjective breathing at 12 weeks. Current ALgI treatments are largely surgical yet offer a marginal improvement in symptoms.  In this study, we will examine the ability of a postextubation medical regime (azithromycin and inhaled budesonide) to improve breathing 12 weeks after ALgI.  METHODS AND ANALYSIS: A prospective, single-centre, double-blinded, randomised, control trial will be conducted at Vanderbilt Medical Center. Participants will be recruited from adult patients in ICUs. Participants will undergo a bedside flexible nasolaryngoscopy for the identification of ALgI within 72 hours postextubation. In addition, participants will be asked to complete peak expiratory flow measurements immediately postintubation. Patients found to have ALgI will be randomised to the placebo control or medical therapy group (azithromycin 250 mg and budesonide 0.5 mg for 14 days). Repeat peak expiratory flow, examination of the larynx and patient-reported Clinical COPD (chronic obstructive pulmonary disease) Questionnaire, Voice Handicap Index and 12-Item Short Form Health Survey questionnaires will be conducted at 12 weeks postextubation. Consented patients will also have patient-specific, disease-specific and procedure-specific covariates abstracted from their medical record.
ETHICS AND DISSEMINATION


The Institutional Review Board (IRB) Committee of the Vanderbilt University Medical Center has approved this protocol (IRB #171066). The findings of the trial will be disseminated through peer-reviewed journals, national and international conferences.
TRIAL REGISTRATION NUMBER


NCT03250975.",2019,Patients found to have ALgI will be randomised to the placebo control or medical therapy group (azithromycin 250 mg and budesonide 0.5 mg for 14 days).,['Participants will be recruited from adult patients in ICUs'],"['postextubation medical regime (azithromycin and inhaled budesonide', 'placebo control or medical therapy group (azithromycin 250\u2009mg and budesonide', 'endotracheal intubation']","['Acute laryngeal injury (ALgI', 'Repeat peak expiratory flow, examination of the larynx and patient-reported Clinical COPD (chronic obstructive pulmonary disease', 'Questionnaire, Voice Handicap Index and 12-Item Short Form Health Survey questionnaires', 'subjective breathing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1596442', 'cui_str': 'Azithromycin 250 MG [Zithromax]'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0339881', 'cui_str': 'Injury of larynx (disorder)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]",,0.310112,Patients found to have ALgI will be randomised to the placebo control or medical therapy group (azithromycin 250 mg and budesonide 0.5 mg for 14 days).,"[{'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Lowery', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Shinn', 'Affiliation': 'Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Chevis', 'Initials': 'C', 'LastName': 'Shannon', 'Affiliation': 'Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Gelbard', 'Affiliation': 'Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]",BMJ open,['10.1136/bmjopen-2018-027963']
3097,31154594,Work Motivation and Employment Outcomes in People with Severe Mental Illness.,"Purpose To study associations between the level of self-reported work motivation and employment outcomes in people with severe mental illness (SMI) enrolled in a vocational rehabilitation program. Methods Data of 151 study participants, collected from a randomised controlled trial with a 30-month follow-up period, were used for a secondary data analysis. Multiple logistic regression, linear regression and cox regression analyses were performed to analyse the association between the level of work motivation at baseline and job obtainment, duration of job, and time until job obtainment during the 30-month follow-up period. Results No statistically significant associations were found between the level of work motivation and job obtainment (OR 1.83, 95% CI 0.55-6.06, p = 0.32), job duration (B = - 0.74, 95% CI - 2.37 to 0.89, p = 0.37, R-squared = 0.03), or time until job obtainment (HR = 1.53, 95% CI 0.64-3.68, p = 0.34). Conclusions The results of this study show no statistically significant associations between the level of work motivation and employment outcomes in people with SMI enrolled in a vocational rehabilitation program. These associations may be underestimated due to range restriction of the work motivation's level. Further research is recommended to increase knowledge on the associations between work motivation and employment outcomes, as it could be relevant for further understanding success in vocational rehabilitation.",2019,The results of this study show no statistically significant associations between the level of work motivation and employment outcomes in people with SMI enrolled in a vocational rehabilitation program.,"['151 study participants', 'People with Severe Mental Illness', 'people with severe mental illness (SMI) enrolled in a vocational rehabilitation program', 'people with SMI enrolled in a vocational rehabilitation program']",[],"['level of work motivation at baseline and job obtainment, duration of job, and time until job obtainment', 'level of work motivation and employment outcomes', 'level of work motivation and job obtainment', 'time until job obtainment', 'Work Motivation and Employment Outcomes', 'job duration']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0034996', 'cui_str': 'Vocational rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}]",[],"[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",151.0,0.0773882,The results of this study show no statistically significant associations between the level of work motivation and employment outcomes in people with SMI enrolled in a vocational rehabilitation program.,"[{'ForeName': 'Miljana', 'Initials': 'M', 'LastName': 'Vukadin', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands. m.vukadin@vumc.nl.'}, {'ForeName': 'Frederieke G', 'Initials': 'FG', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Vlaar', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Jooske T', 'Initials': 'JT', 'LastName': 'van Busschbach', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Harry W C', 'Initials': 'HWC', 'LastName': 'Michon', 'Affiliation': 'Trimbos Institute, The Netherlands Institute of Mental Health and Addiction, Da Costakade 45, 3521 VS, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Anema', 'Affiliation': 'Department of Public and Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, NL-1081 BT, Amsterdam, The Netherlands.'}]",Journal of occupational rehabilitation,['10.1007/s10926-019-09839-0']
3098,32027349,Association of Visit Adherence and Visual Acuity in Patients With Neovascular Age-Related Macular Degeneration: Secondary Analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial.,"Importance


Visit adherence has been shown to play a significant role in patient health outcomes. The effect of missing visits on visual acuity (VA) in individuals with neovascular age-related macular degeneration has yet to be characterized.
Objective


To quantify the association between patients' adherence to randomized clinical trial visits and VA in individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics.
Design, Setting, and Participants


This is a secondary analysis of the Comparison of Age-Related Macular Degeneration Treatment Trial randomized clinical trial. Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009. The 2-year study protocol required 1 visit every 4 weeks (every 21-35 days for a total of 26 visits) for monthly vs pro re nata treatments of bevacizumab vs ranibizumab. Analysis took place from November 2018 through May 2019.
Exposures


Visit adherence was measured in 4 ways: total number of missed visits, average number of days (avg days) between each visit, longest duration in days (max days) between visits, and visit constancy (the tally of 3-month periods with at least 1 visit attended). Average and max days were also categorized as on time (28-35 days), late (36-60 days), and very late (>60 days).
Main Outcomes and Measures


Change in Early Treatment Diabetic Retinopathy Study VA between the baseline and the last visit. Linear multivariate regression models were applied to analyze the association between visit adherence and change in VA, controlling for age, sex, baseline VA, anti-vascular endothelial growth factor drug, number of injections, and dosing regimen.
Results


Of 1178 patients, the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women. The mean (SD) number of missed visits was 2.4 (3.1). Overall, 1091 patients (92.6%) had complete visit constancy during the entire study period. Average days were categorized with 1060 patients (90.0%) classified as on time, 108 (9.2%) were late, and 10 (0.8%) were very late. For max days between visits, 197 patients (16.7%) were on time, 773 (65.6%) were late, and 208 (17.7%) were very late. After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = -5.9) groups saw fewer letters in both the avg and max days categories than patients in the on-time group (P < .001).
Conclusions and Relevance


These results provide evidence to support the concept that visit adherence contributes to VA outcomes in neovascular age-related macular degeneration. The magnitude of the association of visit adherence with VA outcomes in this clinical scenario suggests that substantial effort should be expended to strive for visit adherence or therapeutic strategies that reduce the visit burden without compromising VA outcomes.
Trial Registration


ClinicalTrials.gov Identifier: NCT00593450.",2020,"After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = ","['1178 patients', 'individuals with neovascular age-related macular degeneration', 'the mean (SD) age was 79.1 (7.3) years, and 727 (61.7%) were women', 'individuals with neovascular age-related macular degeneration based on 4 visit adherence metrics', 'Patients With Neovascular Age-Related Macular Degeneration', 'Individuals with age-related macular degeneration were recruited from 44 clinical centers in the United States between February 2008 and December 2009']",['bevacizumab vs ranibizumab'],"['Visit Adherence and Visual Acuity', 'mean (SD) number of missed visits', 'complete visit constancy', 'visual acuity (VA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",,0.152998,"After controlling for covariates, the late (avg days = -6.1; max days = -2.0) and very late (avg days = -12.5; max days = ","[{'ForeName': 'Meera S', 'Initials': 'MS', 'LastName': 'Ramakrishnan', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Yinxi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Center for Preventative Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'VanderBeek', 'Affiliation': 'Scheie Eye Institute, Perelman School of Medicine, Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.4577']
3099,32150232,Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial.,"Importance


Although an estimated 30 million people meet criteria for alcohol use disorder (AUD), few receive appropriate pharmacotherapy. A more personalized, symptom-specific, approach might improve efficacy and acceptance.
Objective


To examine whether gabapentin would be useful in the treatment of AUD, especially in those with the most alcohol withdrawal symptoms.
Design, Setting, and Participants


This double-blind randomized clinical trial conducted between November 2014 and June 2018 evaluated gabapentin vs placebo in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period. A total of 145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria were randomized to treatment after 3 abstinent days. Daily drinking was recorded, and percentage of disialo carbohydrate-deficient transferrin in the blood, a heavy drinking marker, was collected at baseline and monthly during treatment.
Interventions


Gabapentin up to 1200 mg/d, orally, vs placebo along with 9 medical management visits (20 minutes each).
Main Outcomes and Measures


The percentage of individuals with no heavy drinking days and those with total abstinence were compared between treatment groups and further evaluated based on prestudy alcohol withdrawal symptoms.
Results


Of 96 randomized individuals, 90 were evaluable (44 in the gabapentin arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94%). The evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2). The prestudy high-alcohol withdrawal group had positive gabapentin effects on no heavy drinking days (P < .02; NNT, 3.1) and total abstinence (P = .003; NNT, 2.7) compared with placebo, while within the low-alcohol withdrawal group, there were no significant differences. These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only. Gabapentin caused more dizziness, but this did not affect efficacy.
Conclusions and Relevance


These data, combined with others, suggest gabapentin might be most efficacious in people with AUD and a history of alcohol withdrawal symptoms. Future studies should evaluate sleep changes and mood during early recovery as mediators of gabapentin efficacy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02349477.",2020,"These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only.","['in community-recruited participants screened and treated in an academic outpatient setting over a 16-week treatment period', '145 treatment-seeking individuals who met Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria for AUD and were not receiving other AUD intervention were screened, and 96 who also met recent alcohol withdrawal criteria', 'Patients With Alcohol Withdrawal Symptoms', 'arm and 46 in the placebo arm), with a mean (SD) age of 49.6 (10.1) years; 69 were men (77%) and 85 were white (94', 'evaluable participants had 83% baseline heavy drinking days (4 or more drinks/day for women, 5 or more for men) and met 4.5 alcohol withdrawal criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition', 'people with AUD and a history of alcohol withdrawal symptoms', '96 randomized individuals']","['gabapentin', 'Gabapentin', 'placebo', 'gabapentin vs placebo']","['percentage of individuals with no heavy drinking days and those with total abstinence', 'heavy drinking days', 'dizziness', 'total abstinence', 'prestudy alcohol withdrawal symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",,0.35725,"These findings were similar for other drinking variables, where gabapentin was more efficacious than placebo in the high-alcohol withdrawal group only.","[{'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Latham', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Voronin', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Book', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bristol', 'Affiliation': 'Addiction Sciences Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.0249']
3100,32176862,"The Effect of Exercise Training on Total Daily Energy Expenditure and Body Composition in Weight-Stable Adults: A Randomized, Controlled Trial.","BACKGROUND


The present study examined, among weight-stable overweight or obese adults, the effect of increasing doses of exercise energy expenditure (EEex) on changes in total daily energy expenditure (TDEE), total body energy stores, and body composition.
METHODS


Healthy, sedentary overweight/obese young adults were randomized to one of 3 groups for a period of 26 weeks: moderate-exercise (EEex goal of 17.5 kcal/kg/wk), high-exercise (EEex goal of 35 kcal/kg/wk), or observation group. Individuals maintained body weight within 3% of baseline. Pre/postphysical activity between-group measurements included body composition, calculated energy intake, TDEE, energy stores, and resting metabolic rate.
RESULTS


Sixty weight-stable individuals completed the protocols. Exercise groups increased EEex in a stepwise manner compared with the observation group (P < .001). There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate. Fat mass and energy stores decreased among the females in the high-exercise group (P = .007).
CONCLUSIONS


The increase in EEex did not result in an equivalent increase in TDEE. There was a sex difference in the relationship among energy balance components. These results suggest a weight-independent compensatory response to exercise training with potentially a sex-specific adjustment in body composition.",2020,"There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate.","['Healthy, sedentary overweight/obese young adults', 'Weight-Stable Adults', 'Sixty weight-stable individuals completed the protocols', 'weight-stable overweight or obese adults']","['Exercise Training', 'exercise energy expenditure (EEex', 'moderate-exercise (EEex goal of 17.5\xa0kcal/kg/wk), high-exercise (EEex goal of 35\xa0kcal/kg/wk), or observation group']","['Pre/postphysical activity', 'body composition, calculated energy intake, TDEE, energy stores, and resting metabolic rate', 'total daily energy expenditure (TDEE), total body energy stores, and body composition', 'EEex', 'changes in TDEE, energy intake, fat-free mass, or resting metabolic rate', 'Individuals maintained body weight', 'Fat mass and energy stores', 'TDEE', 'Total Daily Energy Expenditure and Body Composition']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0733661,"There was no group effect on changes in TDEE, energy intake, fat-free mass, or resting metabolic rate.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Hand', 'Affiliation': ''}, {'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Shook', 'Affiliation': ''}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Kindred', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Schumacher', 'Affiliation': ''}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Drenowatz', 'Affiliation': ''}, {'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Paluch', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Burgess', 'Affiliation': ''}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': ''}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0415']
3101,31904403,Exposure to violence and neglect images differentially influences fear learning and extinction.,"The mechanisms by which exposure to adversity contributes to psychopathology development are poorly understood. Recent models link experiences of threat of harm and deprivation to psychopathology via disruptions in learning mechanisms underlying fear acquisition and extinction. We empirically tested dimensional elements of this model, by examining whether exposure to images of community violence or neglect differentially influenced fear learning and extinction relative to exposure to neutral images. Participants were randomly allocated to one of three exposure conditions: viewing images depicting neglect (n = 25), violence (n = 25) or control images (n = 24). All participants then completed a fear conditioning and extinction task in which the CS+ was paired with an aversive tone, and the CS- was presented alone during conditioning. Both CSs were presented alone during extinction and extinction retest. Skin conductance responses (SCR) and subjective ratings were assessed. Relative to control images, viewing scenes of neglect attenuated SCRs to the CSs during conditioning, extinction and extinction retest. Exposure to images of community violence accentuated SCRs during US anticipation on CS+ trials and impaired the retention of safety learning (larger SCRs to the CS+ compared to the CS- at retest and the CS+ at the end of extinction). No significant group differences emerged in subjective ratings. Findings lend preliminary support for suggestions that adverse experiences may be linked to impairments in fear and safety learning and provide key evidence suggesting that the expression of these impairments may differ as a function of the type of adversity.",2020,Exposure to images of community violence accentuated SCRs during US anticipation on CS + trials and impaired the retention of safety learning (larger SCRs to the CS + compared to the CS- at retest and the CS + at the end of extinction).,[],"['three exposure conditions: viewing images depicting neglect (n = 25), violence (n = 25) or control images']","['Skin conductance responses (SCR) and subjective ratings', 'subjective ratings', 'retention of safety learning']",[],"[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0169791,Exposure to images of community violence accentuated SCRs during US anticipation on CS + trials and impaired the retention of safety learning (larger SCRs to the CS + compared to the CS- at retest and the CS + at the end of extinction).,"[{'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Modecki', 'Affiliation': 'School of Applied Psychology, Griffith University, Australia. Electronic address: k.modecki@griffith.edu.au.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murphy', 'Affiliation': 'School of Applied Psychology, Griffith University, Australia.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Waters', 'Affiliation': 'School of Applied Psychology, Griffith University, Australia. Electronic address: a.waters@griffith.edu.au.'}]",Biological psychology,['10.1016/j.biopsycho.2019.107832']
3102,32080074,A clinical pilot study to evaluate the efficacy of oral intake of phellinus linteus (sanghuang) extract on knee joint and articular cartilage: Study protocol clinical trial (SPIRIT Compliant).,"BACKGROUND


Knee osteoarthritis (KOA) is the most common form of degenerative arthritis. We used Phellinus linteus (PL), which has been well-known anti-inflammatory function. In this study, we will evaluate if PL extract improves symptoms with KOA.
METHODS


This study will be an 8-week single-center randomized controlled double-blind clinical trial. Total of 24 subjects with KOA will be enrolled and they will be divided into 3 groups, PL 1,000 mg, PL 1,500 mg and placebo. Subjects will be followed up every 4 weeks with efficacy and safety at the 2nd and 3rd visits. All subjects should maintain a dosage schedule for this protocol. The primary outcome will be assessed with the Korean version of the Western Ontario and McMasters Universities. And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen. Statistical analysis will be performed on the principle of full analysis set.
DISCUSSION


This study has inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is the first step to assess the efficacy and safety of PL in patients with KOA. This study will make an important contribution to the literature and aid follow-up research into the use of PL in KOA.",2020,"And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen.","['knee joint and articular cartilage', 'Total of 24 subjects with KOA', 'Knee osteoarthritis (KOA', 'patients with KOA']","['PL', 'PL extract', 'PL 1,000\u200amg, PL 1,500\u200amg and placebo', 'phellinus linteus (sanghuang) extract']","['efficacy and safety', 'Korean version of the Western Ontario and McMasters Universities', 'visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen']","[{'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C0007303', 'cui_str': 'Cartilage, Articular'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2003783', 'cui_str': 'Phellinus linteus extract'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0009331', 'cui_str': 'Collagen Type II'}]",24.0,0.132569,"And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen.","[{'ForeName': 'Yong Ho', 'Initials': 'YH', 'LastName': 'Ku', 'Affiliation': 'Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Hwa Yeon', 'Initials': 'HY', 'LastName': 'Ryu', 'Affiliation': ''}, {'ForeName': 'Jae Hui', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000018912']
3103,32120378,Moderators in a physical activity intervention for adolescent girls.,"BACKGROUND


The purpose was to explore whether baseline sociodemographic and physical characteristics moderated effects of an intervention on moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF) at post intervention, relative to the control condition.
METHODS


A secondary analysis of data from a group randomized trial including 24 schools (12 intervention and 12 control; N = 1519 girls) was conducted. Age, ethnicity, race, socioeconomic status, and pubertal stage were assessed via survey. Height, weight, MVPA (min/h), percent body fat, and CRF were measured. Mixed-effects linear models were performed.
RESULTS


Compared to the control, the intervention increased overweight and obese girls' CRF (b = 0.28, p = 0.049; b = 0.31, p < 0.01, respectively), but not healthy weight girls' CRF (b = 0.04, p = 0.706). Pre- to mid-puberty girls in the intervention group had slightly lower post-intervention MVPA than those in the control (3.04 vs. 3.31, p = 0.055), while late to post-puberty intervention and control girls' post-intervention MVPA was similar (3.12 vs. 3.04, p = 0.542).
CONCLUSIONS


A PA intervention can improve overweight and obese girls' CRF, possibly attenuating their cardiovascular risk. Effective strategies are needed to assist adolescent girls, especially those in pre- to mid-puberty, in maintaining their MVPA after an intervention ends.
IMPACT


Moderators of physical activity intervention effects among adolescent girls are important to identify because the effectiveness of these interventions to date in this population has been limited.This article contributes to the notable gap in knowledge regarding moderators in physical activity interventions involving adolescent girls, particularly baseline characteristics that may moderate their responses to physical activity interventions. Awareness of the moderators can be useful for determining the type of intervention that may be successful in subgroups of adolescent girls and for tailoring a physical activity intervention to optimally meet each girl's needs to achieve maximal effects.Findings show that weight status moderated the intervention effects on cardiorespiratory fitness. Compared to the control condition, the intervention increased overweight and obese, but not healthy weight, girls' cardiorespiratory fitness.A physical activity intervention can improve overweight and obese girls' cardiorespiratory fitness, possibly attenuating their cardiovascular risk. Therefore, it is essential to include overweight and obese girls in PA interventions to help them reap this important benefit.",2020,"Compared to the control, the intervention increased overweight and obese girls' CRF (F = 4.36, p = 0.037; F = 6.56, p = 0.011, respectively), but not healthy weight girls' CRF (F = 0.01, p = 0.925).","['adolescent girls', '24 schools (12 intervention and 12 control; N\u2009=\u20091519 girls']","['physical activity intervention', 'PA intervention']","['Height, weight, MVPA (min/h), percent body fat, and CRF', 'cardiorespiratory fitness', 'moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF', ""overweight and obese girls' CRF""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",1519.0,0.0162252,"Compared to the control, the intervention increased overweight and obese girls' CRF (F = 4.36, p = 0.037; F = 6.56, p = 0.011, respectively), but not healthy weight girls' CRF (F = 0.01, p = 0.925).","[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA. robbin76@msu.edu.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': 'Center for Family Health, 505 N Jackson St, Jackson, MI, USA.'}]",Pediatric research,['10.1038/s41390-020-0818-5']
3104,31851290,Association of Prehospital Plasma Transfusion With Survival in Trauma Patients With Hemorrhagic Shock When Transport Times Are Longer Than 20 Minutes: A Post Hoc Analysis of the PAMPer and COMBAT Clinical Trials.,"Importance


Both military and civilian clinical practice guidelines include early plasma transfusion to achieve a plasma to red cell ratio approaching 1:1 to 1:2. However, it was not known how early plasma should be given for optimal benefit. Two recent randomized clinical trials were published, with apparently contradictory results. The Prehospital Air Medical Plasma (PAMPer) clinical trial showed a nearly 30% reduction in mortality with plasma transfusion in the prehospital environment, while the Control of Major Bleeding After Trauma (COMBAT) clinical trial showed no survival improvement.
Objective


To facilitate a post hoc combined analysis of the COMBAT and PAMPer trials to examine questions that could not be answered by either clinical trial alone. We hypothesized that prehospital transport time influenced the effects of prehospital plasma on 28-day mortality.
Design, Setting, and Participants


A total of 626 patients in the 2 clinical trials were included. Patients with trauma and hemorrhagic shock were randomly assigned to receive either standard care or 2 U of thawed plasma followed by standard care in the prehospital environment. Data analysis was performed between September 2018 and January 2019.
Interventions


Prehospital transfusion of 2 U of plasma compared with crystalloid-based resuscitation.
Main Outcomes and Measures


The main outcome was 28-day mortality.
Results


In this post hoc analysis of 626 patients (467 men [74.6%] and 159 women [25.4%]; median [interquartile range] age, 42 [27-57] years) who had trauma with hemorrhagic shock, a Cox regression analysis showed a significant overall survival benefit for plasma (hazard ratio [HR], 0.65; 95% CI, 0.47-0.90; P = .01) after adjustment for injury severity, age, and clinical trial cohort (COMBAT or PAMPer). A significant association with prehospital transport time was detected (from arrival on scene to arrival at the trauma center). Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46). No serious adverse events were associated with prehospital plasma transfusion.
Conclusions and Relevance


These data suggest that prehospital plasma is associated with a survival benefit when transport times are longer than 20 minutes and that the benefit-risk ratio is favorable for use of prehospital plasma.
Trial Registration


ClinicalTrials.gov identifiers: NCT01838863 (COMBAT) and NCT01818427 (PAMPer).",2020,"Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46).","['626 patients in the 2 clinical trials were included', 'Patients with trauma and hemorrhagic shock', 'Trauma Patients With Hemorrhagic Shock', '626 patients (467 men [74.6%] and 159 women [25.4%]; median [interquartile range] age, 42 [27-57] years) who had trauma with hemorrhagic shock']","['crystalloid-based resuscitation', 'standard care or 2 U of thawed plasma followed by standard care in the prehospital environment']","['28-day mortality', 'survival improvement', 'Increased mortality', 'mortality', 'Control of Major Bleeding', 'prehospital transport', 'overall survival benefit for plasma', 'prehospital transport time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C4517784', 'cui_str': '467 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",467.0,0.389729,"Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46).","[{'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'US Army Institute of Surgical Research, JBSA-Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Tuan D', 'Initials': 'TD', 'LastName': 'Le', 'Affiliation': 'US Army Institute of Surgical Research, JBSA-Fort Sam Houston, San Antonio, Texas.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'Division of Emergency Medicine, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'Department of Radiology, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'Department of Health Systems, Management, and Policy, School of Public Health, University of Colorado Denver, Aurora.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Ghasabyan', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chandler', 'Affiliation': 'Department of Surgery, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McVaney', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, University of Colorado Denver, Aurora.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Daley', 'Affiliation': 'Department of Surgery, University of Tennessee Health Science Center, Knoxville.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Miller', 'Affiliation': 'Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Harbrecht', 'Affiliation': 'Department of Surgery, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Claridge', 'Affiliation': 'MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Herb A', 'Initials': 'HA', 'LastName': 'Phelan', 'Affiliation': 'Department of Surgery, Parkland Memorial Hospital, University of Texas Southwestern, Dallas.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Witham', 'Affiliation': 'Texas Health Harris Methodist Hospital, Ft Worth, Texas.'}, {'ForeName': 'A Tyler', 'Initials': 'AT', 'LastName': 'Putnam', 'Affiliation': 'Altoona Hospital, University of Pittsburgh Medical Center, Altoona, Pennsylvania.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'Division of Trauma and General Surgery, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}]",JAMA surgery,['10.1001/jamasurg.2019.5085']
3105,32183831,Randomized controlled trial on the effectiveness of absorbable collagen sponge after extraction of impacted mandibular third molar: split-mouth design.,"BACKGROUND


The purpose of this study was to compare the effectiveness of absorbable collagen sponge insertion in tooth extraction sites for socket healing of the impacted mandibular third molar.
METHODS


Thirty-six patients with bilateral mandibular impacted third molars based on Pell-Gregory and Winter classification were included in this study. This study was a randomized clinical trial utilizing a split-mouth design with one side assigned as collagen sponge insertion and the other side assigned as the control. Post-operative clinical complications, periodontal integrities, and radiographic outcomes were assessed at 1, 2, and 14-weeks post operatively.
RESULTS


Five patients were excluded during the follow-up period due to loss of follow-up. The study was conducted on 31 patients in total. The mean VAS score of collagen sponge insertion side at 1 week post operation was 1.42 ± 1.26, which was significantly lower than the control side (P < 0.05). The mean probing depth of collagen sponge insertion side at 2-week post operation was 5.55 ± 2.28 mm, which was significantly lower than the control side (7.13 ± 1.86; P < 0.05). Other various measurements including radiographic outcomes showed no significant group differences.
CONCLUSIONS


Placement of collagen sponge after extraction of mandibular impacted third molar reduced early stage post-operative complications and enhanced initial healing of soft tissues and periodontal defects.
TRIAL REGISTRATION


This study was retrospectively registered at the WHO ICTRP platform and Clinical Research Information Service, KCT0003363. Registered 21 Sep 2018.",2020,"CONCLUSIONS


Placement of collagen sponge after extraction of mandibular impacted third molar reduced early stage post-operative complications and enhanced initial healing of soft tissues and periodontal defects.
","['31 patients in total', 'socket healing of the impacted mandibular third molar', 'Thirty-six patients with bilateral mandibular impacted third molars based on Pell-Gregory and Winter classification were included in this study']","['absorbable collagen sponge insertion', 'absorbable collagen sponge']","['Post-operative clinical complications, periodontal integrities, and radiographic outcomes', 'mean VAS score of collagen sponge insertion side', 'radiographic outcomes', 'mean probing depth of collagen sponge insertion side']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C1705741', 'cui_str': 'Sponge (basic dose form)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",5.0,0.161092,"CONCLUSIONS


Placement of collagen sponge after extraction of mandibular impacted third molar reduced early stage post-operative complications and enhanced initial healing of soft tissues and periodontal defects.
","[{'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Tae-Whan', 'Initials': 'TW', 'LastName': 'Seong', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Sura', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Medicine, Ewha Womans University, Seoul, South Korea.'}, {'ForeName': 'Sun-Jong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Medicine, Ewha Womans University, Seoul, South Korea. oralsurgeonsj@gmail.com.'}]",BMC oral health,['10.1186/s12903-020-1063-3']
3106,32183875,"Autologous adipose-derived stem cells for the treatment of Crohn's fistula-in-ano: an open-label, controlled trial.","BACKGROUND


Crohn's fistula-in-ano is a refractory disease in colorectal and anal surgery. Although autologous adipose-derived stem cell (ADSC) has been used in the treatment of Crohn's fistula-in-ano because of its convenience, non-incision of normal tissue, good tolerance, repeatability, quick recovery, less pain, less damage to anal function, and high quality of life during the perioperative period, there are no reports of its use in China. This is the first clinical trial in China on the treatment of Crohn's fistula-in-ano with ADSC to evaluate its efficacy and safety.
METHODS


A total of 22 patients with Crohn's fistula-in-ano were enrolled in this study from January 2018 to October 2018 in the Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were divided (1:1) into an observation group (ADSC) and a control group (incision-thread-drawing procedure). Primary efficacy endpoint evaluated at months 3, 6, and 12 was the closure of fistulas (closure of all treated fistulas at baseline, confirmed by doctor's clinical assessment and magnetic resonance imaging or transrectal ultrasonography). The patients additionally completed some scoring scales at each follow-up including simplified Crohn's Disease Activity Index (CDAI), Perianal Disease Activity Index (PDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), pain scores with visual analog score (VAS), and Wexner score. The data of inflammatory indexes were also collected.
RESULTS


The healing rates of the observation group and the control group at months 3, 6, and 12 were as follows: 10/11(90.9%) vs 5/11(45.5%), 8/11(72.7%) vs 6/11(54.5%), and 7/11(63.6%) vs 6/11(54.5%), respectively. There was no statistical difference between the two groups. In addition, the improvement in simplified CDAI, PDAI, IBDQ, VAS, and Wexner score of the observation group were better than that of the control group at each follow-up. The inflammatory indexes decreased in both the observation group and the control group at 3 months follow-up. And there were no significant differences in the changes of inflammatory indexes between two groups at month 3 compared with the baseline. Safety was maintained throughout month 12, and adverse events occurred in 63.6% of patients in the observation group and 100% patients in the control group. And no adverse event associated with ADSC injection was observed in the study.
CONCLUSION


ADSC is a feasible and effective treatment for Crohn's fistula-in-ano, compared with traditional incision and thread-drawing. It can protect anal function of patients, relieve pain, allow quick recovery, be well-tolerated, and improve the quality of life during perioperative period.
TRIAL REGISTRATION


China Clinical Trials Registry, No. ChiCTR1800014599. Registered 23 January 2018.",2020,"ADSC is a feasible and effective treatment for Crohn's fistula-in-ano, compared with traditional incision and thread-drawing.","[""22 patients with Crohn's fistula-in-ano were enrolled in this study from January 2018 to October 2018 in the Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine""]","['observation group (ADSC) and a control group (incision-thread-drawing procedure', 'autologous adipose-derived stem cell (ADSC', 'ADSC', 'Autologous adipose-derived stem cells']","['adverse events', 'changes of inflammatory indexes', ""closure of fistulas (closure of all treated fistulas at baseline, confirmed by doctor's clinical assessment and magnetic resonance imaging or transrectal ultrasonography"", 'quality of life', 'healing rates', ""simplified Crohn's Disease Activity Index (CDAI), Perianal Disease Activity Index (PDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), pain scores with visual analog score (VAS), and Wexner score"", 'Safety', 'inflammatory indexes', 'simplified CDAI, PDAI, IBDQ, VAS, and Wexner score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010346', 'cui_str': 'Regional Enteritis'}, {'cui': 'C0205929', 'cui_str': 'Anal Fistula'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0034380'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0451071', 'cui_str': ""Crohn's disease activity index (assessment scale)""}, {'cui': 'C0442158', 'cui_str': 'Perianal region structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",22.0,0.0504721,"ADSC is a feasible and effective treatment for Crohn's fistula-in-ano, compared with traditional incision and thread-drawing.","[{'ForeName': 'Chungen', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Graduate School of Nanjing University of Chinese Medicine, Nanjing, 210029, Jiangsu Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China.'}, {'ForeName': 'Yehuang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China.'}, {'ForeName': 'Dachao', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Reaserch Institute of Jiangsu Decon Bio-science Technologies Company Ltd., Nanjing, 210000, Jiangsu Province, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Zhongda Hospital Southeast University, Nanjing, 210009, Jiangsu Province, China.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Zhongda Hospital Southeast University, Nanjing, 210009, Jiangsu Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Yale School of Engineering & Applied Science, New Haven, 06520-8292, Connecticut, USA. 1091523245@qq.com.'}, {'ForeName': 'Sumin', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China. chenmin740@hotmail.com.'}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Reaserch Institute of Jiangsu Decon Bio-science Technologies Company Ltd., Nanjing, 210000, Jiangsu Province, China. shi_hongzhen@deconbio.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Colorectal Disease Center of Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, 210022, Jiangsu Province, China. jbfirsth@aliyun.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01636-4']
3107,32050833,Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial.,"Alveolar ridge preservation (ARP) therapy is indicated to attenuate the physiologic resorptive events that occur as a consequence of tooth extraction with the purpose of facilitating tooth replacement therapy. This randomized controlled trial was primarily aimed at testing the efficacy of ARP as compared with unassisted socket healing. A secondary objective was to evaluate the effect that local phenotypic factors play in the volumetric reduction of the alveolar bone. A total of 53 subjects completed the study. Subjects were randomized into either the control group, which involved only tooth extraction (EXT  n  = 27), or the experimental group, which received ARP using a combination of socket grafting with a particulate bone allograft and socket sealing with a nonabsorbable membrane (dPTFE) following tooth extraction (ARP  n  = 26). A set of clinical, linear, volumetric, implant-related, and patient-reported outcomes were assessed during a 14-wk healing period. All linear bone assessments (horizontal, midbuccal, and midlingual reduction) revealed that ARP is superior to EXT. Likewise, volumetric bone resorption was significantly higher in the control group (mean ± SD: EXT = -15.83% ± 4.48%, ARP = -8.36% ± 3.81%,  P  < 0.0001). Linear regression analyses revealed that baseline buccal bone thickness is a strong predictor of alveolar bone resorption in both groups. Interestingly, no significant differences in terms of soft tissue contour change were observed between groups. Additional bone augmentation to facilitate implant placement in a prosthetically acceptable position was deemed necessary in 48.1% of the EXT sites and only 11.5% of the ARP sites ( P  < 0.004). Assessment of perceived postoperative discomfort at each follow-up visit revealed a progressive decrease over time, which was comparable between groups. Although some extent of alveolar ridge remodeling occurred in both groups, ARP therapy was superior to EXT as it was more efficacious in the maintenance of alveolar bone and reduced the estimated need for additional bone augmentation at the time of implant placement (ClinicalTrials.gov NCT01794806).",2020,"Likewise, volumetric bone resorption was significantly higher in the control group (mean ± SD: EXT = -15.83% ± 4.48%, ARP = -8.36% ± 3.81%,  P  < 0.0001).",['53 subjects completed the study'],"['ARP', 'control group, which involved only tooth extraction (EXT  n  = 27), or the experimental group, which received ARP using a combination of socket grafting with a particulate bone allograft and socket sealing with a nonabsorbable membrane (dPTFE', 'Alveolar Ridge Preservation', 'Alveolar ridge preservation (ARP) therapy']","['postoperative discomfort', 'soft tissue contour change', 'volumetric bone resorption', 'alveolar bone resorption', 'alveolar ridge remodeling']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2354284', 'cui_str': 'socket graft'}, {'cui': 'C0457784', 'cui_str': 'Particulate (finding)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C3805122', 'cui_str': 'Alveolar bone resorption'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure (body structure)'}]",53.0,0.0934887,"Likewise, volumetric bone resorption was significantly higher in the control group (mean ± SD: EXT = -15.83% ± 4.48%, ARP = -8.36% ± 3.81%,  P  < 0.0001).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Avila-Ortiz', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gubler', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Romero-Bustillos', 'Affiliation': 'Department of Periodontics, College of Dentistry, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Nicholas', 'Affiliation': 'Department of Orthodontics, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'Biostatistics Consulting Center, College of Public Health, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Barwacz', 'Affiliation': 'Department of Family Dentistry, College of Dentistry, University of Iowa, Iowa City, IA, USA.'}]",Journal of dental research,['10.1177/0022034520905660']
3108,32105658,Correlation Between Oral Health and Systemic Inflammation (COHESION): A Randomized Pilot Follow-Up Trial of a Plaque-Identifying Toothpaste.,"BACKGROUND


Inflammation is intimately involved in the pathogenesis of atherosclerosis and is accurately measured by high-sensitivity C-reactive protein (hs-CRP), a sensitive marker for future risk of cardiovascular disease. The Correlation between Oral Health and Systemic Inflammation (COHESION) trial was designed to test the hypothesis that PlaqueHD, a plaque-identifying toothpaste, reduces hs-CRP.
METHODS


The trial was designed initially to include 132 subjects with hs-CRP between 2.0 and 10.0 mg/L but instead randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow-up data and comprised the intention-to-treat sample. Of these, a prespecified subgroup analysis included 40 with baseline hs-CRP >2.0 and all hs-CRP <10. Because the distribution of hs-CRP was skewed toward higher values, to achieve normality assumptions, the significance of changes in hs-CRP between groups over time was tested on log-transformed data using a mixed effects analysis of variance.
RESULTS


The intention-to-treat analysis showed no significant differences between the PlaqueHD and placebo group (P = .615). The prespecified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (P = .047). Results of the analysis showed a reduction in hs-CRP at follow-up of 0.58 in the PlaqueHD and an increase of 0.55 in the placebo group.
CONCLUSIONS


These findings are compatible with those of a prior pilot trial that also suggested benefits only in subjects with baseline elevations. Future trials targeting reductions of hs-CRP levels should randomize subjects with baseline hs-CRP between 2.0 and 10.0 mg/L.",2020,The pre-specified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (p=0.047).,"['COHESION was designed initially to enroll 132 subjects with hs-CRP between 2.0 and 10.0 milligrams per liter but randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow up data and comprise the intention to treat sample']","['placebo', 'Plaque Identifying Toothpaste']",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439210', 'cui_str': 'milligram'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}]",[],112.0,0.42989,The pre-specified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (p=0.047).,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Acharya', 'Affiliation': 'Marshfield Clinic Research Institute, Marshfield, WI; University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Glurich', 'Affiliation': 'Marshfield Clinic Research Institute, Marshfield, WI.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Tattersall', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, Madison, WI.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hennekens', 'Affiliation': 'Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL. Electronic address: PROFCHHMD@prodigy.net.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.01.023']
3109,32112718,Does Piezosurgery Decrease Patient Morbidity in Surgically Assisted Rapid Palatal Expansion Compared With Saw and Burrs?,"PURPOSE


The present study compared the postoperative pain, edema, patient satisfaction, and operating time with the use of piezosurgery, a reciprocal microsaw, and conventional burrs in the surgically assisted rapid palatal expansion (SARPE) technique for the correction of transversal maxillary deficiency. The results of the present study may help clinicians minimize the postoperative complaints of patients after SARPE.
PATIENTS AND METHODS


The present randomized single-blind study included patients who had undergone SARPE with piezosurgery, a reciprocating microsaw, or conventional burrs. To determine the facial norms and postoperative facial edema, 4 anatomic distances were measured on the patients' face using the modified flexible ruler method. The mean facial edema score was determined to evaluate and compare the overall edema among the groups. Two separate visual analog scales were used to assess patients' postoperative pain and intraoperative satisfaction. The duration of the osteotomies was recorded. Intragroup data were statistically analyzed via a t test, and intergroup data were analyzed via a nonparametric Kruskal-Wallis test. Spearman's correlation was used to evaluate the relationships among the variables.
RESULTS


For the 80 patients, edema (second day: piezosurgery, 0.53 ± 0.34; microsaw, 0.61 ± 0.30; burrs, 0.94 ± 0.33; P < .001) and pain (piezosurgery, 2.3 ± 0.3; microsaw, 3.6 ± 0.4; burrs, 3.9 ± 0.6; P < .001) were greater for conventional burrs and microsaws, with statistically significant differences. Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery. However, in the piezosurgery group, the duration of osteotomies was 50% greater (piezosurgery, 16.10 ± 3.30; microsaw, 11.05 ± 2.09; burrs, 11.2 ± 2.14; P < .001).
CONCLUSIONS


The results from the present study have shown that piezosurgery is an effective method for minimizing facial edema and patient morbidity and increasing patient satisfaction during SARPE. Moreover, the use of conventional burrs and microsaws prolonged the duration of facial edema.",2020,"Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery.","['patients who had undergone SARPE with piezosurgery, a reciprocating microsaw, or conventional burrs']",['surgically assisted rapid palatal expansion (SARPE) technique'],"['duration of the osteotomies', 'facial norms and postoperative facial edema, 4 anatomic distances', 'postoperative pain, edema, patient satisfaction, and operating time with the use of piezosurgery, a reciprocal microsaw, and conventional burrs', 'duration of osteotomies', 'mean facial edema score', 'postoperative pain and intraoperative satisfaction', 'Patient satisfaction', 'duration of facial edema', 'overall edema']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0030212', 'cui_str': 'Palatal Expansion Technic'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0330093', 'cui_str': 'Burr (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0760889,"Patient satisfaction (piezosurgery, 8.3 ± 0.3; microsaw, 5.5 ± 0.5; burrs, 5.1 ± 0.9; P < .001) was greater with piezosurgery.","[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Küçükkurt', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Istanbul Aydın University, Istanbul, Turkey. Electronic address: sercankucukkurt@aydin.edu.tr.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Değerliyurt', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Istanbul Aydın University, Istanbul, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.030']
3110,32053162,Neuro-Ophthalmologic Response to Repetitive Subconcussive Head Impacts: A Randomized Clinical Trial.,"Importance


Subconcussive head impacts have emerged as a complex public health concern. The oculomotor system is sensitive to brain trauma; however, neuro-ophthalmologic response to subconcussive head impacts remains unclear.
Objective


To examine whether subconcussive head impacts cause impairments in neuro-ophthalmologic function as measured by the King-Devick test (KDT) and oculomotor function as measured by the near point of convergence.
Design, Setting, and Participants


In this randomized clinical trial, adult soccer players were randomized into either a heading group or kicking (control) group. The heading group executed 10 headers with soccer balls projected at a speed of 25 mph. The kicking-control group followed the same protocol but with 10 kicks. Peak linear and rotational head accelerations were assessed with a triaxial accelerometer. The KDT speed and error and near point of convergence were assessed at baseline (preheading or prekicking) and at 0, 2, and 24 hours after heading or kicking.
Exposures


Ten soccer-ball headings or kicks.
Main Outcomes and Measures


The primary outcome was the group-by-time interaction of KDT speed at 0 hours after heading or kicking. The secondary outcomes included KDT speed at 2 hours and 24 hours after heading or kicking, KDT error, and near point of convergence.
Results


A total of 78 individuals enrolled (heading group, n = 40; kicking-control group, n = 38). Eleven individuals (heading group: 4 women; mean [SD] age, 22.5 [1.0] years; kicking-control group, 3 women and 4 men; mean [SD] age, 20.9 [1.1] years) voluntarily withdrew from the study. Data from 67 participants with a mean (SD) age of 20.6 (1.7) years were eligible for analysis (heading, n = 36; kicking-control, n = 31). Mean (SD) peak linear accelerations and peak rotational accelerations per impact for the heading group were 33.2 (6.8) g and 3.6 (1.4) krad/s2, respectively. Conversely, soccer kicking did not induce a detectable level of head acceleration. Both groups showed improvements in KDT speed (heading group: 0 hours, -1.2 [95% CI, -2.2 to -0.1] seconds; P = .03; 2 hours, -1.3 [95% CI, -2.6 to 0] seconds; P = .05; 24 hours, -3.2 [95% CI, -4.3 to -2.2] seconds; P < .001; kicking-control group: 0 hours, -3.3 [95% CI, -4.1 to -2.5] seconds; P < .001; 2 hours, -4.1 [95% CI, -5.1 to -3.1] seconds; P < .001; 24 hours, -5.2 [95% CI, -6.2 to -4.2] seconds; P < .001). Group differences occurred at all postintervention points; the kicking-control group performed KDT faster at 0 hours (-2.2 [95% CI, -0.8 to -3.5] seconds; P = .001), 2 hours (-2.8 [95% CI, -1.2 to -4.4] seconds; P < .001), and 24 hours after the intervention (-2.0 [95% CI, -0.5 to -3.4] seconds; P = .007) compared with those of the heading group.
Conclusions and Relevance


These data support the hypothesis that neuro-ophthalmologic function is affected, at least in the short term, by subconcussive head impacts that may affect some individuals in some contact sports. Further studies may help determine if these measures can be a useful clinical tool in detecting acute subconcussive injury.
Trial Registration


ClinicalTrials.gov Identifier: NCT03488381.",2020,"Group differences occurred at all postintervention points; the kicking-control group performed KDT faster at 0 hours (-2.2 [95% CI, -0.8 to -3.5] seconds; P = .001), 2 hours (-2.8 [95% CI, -1.2 to -4.4] seconds; P < .001), and 24 hours after the intervention (-2.0 [95% CI, -0.5 to -3.4] seconds; P = .007) compared with those of the heading group.
","['78 individuals enrolled (heading group, n\u2009=\u200940; kicking-control group, n\u2009=\u200938', 'Exposures\n\n\nTen soccer-ball headings or kicks', 'Eleven individuals (heading group: 4 women; mean [SD] age, 22.5 [1.0] years; kicking-control group, 3 women and 4 men; mean [SD] age, 20.9 [1.1] years) voluntarily withdrew from the study', '67 participants with a mean (SD) age of 20.6 (1.7) years were eligible for analysis (heading, n\u2009=\u200936; kicking-control, n\u2009=\u200931', 'adult soccer players']","['heading group or kicking (control', 'Repetitive Subconcussive Head Impacts']","['King-Devick test (KDT) and oculomotor function', 'KDT speed', 'group-by-time interaction of KDT speed', 'Mean (SD) peak linear accelerations and peak rotational accelerations per impact', 'KDT speed at 2 hours and 24 hours after heading or kicking, KDT error, and near point of convergence', 'Peak linear and rotational head accelerations', 'KDT speed and error and near point of convergence']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0336986', 'cui_str': 'Football'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}]","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0429572', 'cui_str': 'Near point'}, {'cui': 'C0443193', 'cui_str': 'Convergence (qualifier value)'}]",78.0,0.191191,"Group differences occurred at all postintervention points; the kicking-control group performed KDT faster at 0 hours (-2.2 [95% CI, -0.8 to -3.5] seconds; P = .001), 2 hours (-2.8 [95% CI, -1.2 to -4.4] seconds; P < .001), and 24 hours after the intervention (-2.0 [95% CI, -0.5 to -3.4] seconds; P = .007) compared with those of the heading group.
","[{'ForeName': 'Madeleine K', 'Initials': 'MK', 'LastName': 'Nowak', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Zachary W', 'Initials': 'ZW', 'LastName': 'Bevilacqua', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ejima', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Huibregtse', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Zhongxue', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Mickleborough', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}, {'ForeName': 'Sharlene D', 'Initials': 'SD', 'LastName': 'Newman', 'Affiliation': 'Department of Psychological and Brain Sciences, Indiana University College of Arts and Sciences, Bloomington.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Kawata', 'Affiliation': 'Department of Kinesiology, Indiana University School of Public Health-Bloomington, Bloomington.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2019.6128']
3111,31930358,An Athletic Coach-Delivered Middle School Gender Violence Prevention Program: A Cluster Randomized Clinical Trial.,"Importance


Adolescent relationship abuse (ARA) and sexual violence (SV) reported among adolescents point to the need for prevention among middle school-age youths.
Objective


To test an athletic coach-delivered relationship abuse and sexual violence prevention program among middle school male athletes.
Design, Setting, and Participants


An unblinded cluster randomized clinical trial from spring 2015 to fall 2017 at 41 middle schools (38 clusters). The study included 973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86%).
Interventions


Coaching Boys Into Men (CBIM) is a prevention program that trains athletic coaches to talk to male athletes about (1) respectful relationship behaviors, (2) promoting more gender-equitable attitudes, and (3) positive bystander intervention when harmful behaviors among peers are witnessed.
Main Outcomes and Measures


The primary outcome was change in positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up).
Results


Of the 973 participants, 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported. Positive bystander behaviors increased at end of sports season and at 1-year follow-up (relative risk, 1.51; 95% CI, 1.06-2.16 and 1.53; 95% CI, 1.10-2.12, respectively) as did recognition of abuse (mean risk difference, 0.14; 95% CI, 0.01-0.27 and 0.14; 95% CI, 0.00-0.28, respectively). At 1-year follow-up, among those who ever dated, athletes on teams receiving CBIM had lower odds of reporting recent ARA/SV perpetration (odds ratio, 0.24; 95% CI, 0.09-0.65). Gender attitudes and intentions to intervene did not differ between study arms. In exploratory intensity-adjusted and per protocol analyses, athletes on teams receiving CBIM were more likely to report positive bystander behaviors and to endorse equitable gender attitudes and less likely to report ARA and sexual harassment perpetration 1 year later.
Conclusions and Relevance


An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
Trial Registration


ClinicalTrials.gov Identifier: NCT02331238.",2020,"An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
","[' 530 were white (54.5%), 282 were black (29.0%), 14 were Hispanic (1.4%), and the remainder were multiracial, other race/ethnicity, or not reported', 'spring 2015 to fall 2017 at 41 middle schools (38 clusters', 'younger adolescents', 'middle school-age youths', '973 participants', 'middle-school male athletes', '973 male middle school athletes (ages 11-14 years; grades 6-8; participation rate 50%) followed up for 1 year (retention 86', 'middle school male athletes']","['Interventions\n\n\nCoaching Boys Into Men (CBIM', 'Athletic Coach-Delivered Middle School Gender Violence Prevention Program', 'athletic coach-delivered program', 'athletic coach-delivered relationship abuse and sexual violence prevention program']","['Importance\n\n\nAdolescent relationship abuse (ARA) and sexual violence (SV', ""positive bystander behaviors (ie, intervening in peers' disrespectful or harmful behaviors); secondary outcomes were changes in recognition of what constitutes abusive behavior, intentions to intervene, gender-equitable attitudes, and reduction in recent ARA/SV perpetration (at end of sports season and 1-year follow up"", 'Gender attitudes and intentions to intervene', 'Positive bystander behaviors']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0237220', 'cui_str': 'Abusive behavior (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",973.0,0.124896,"An athletic coach-delivered program for middle school male athletes is an effective strategy for reducing relationship abuse among younger adolescents.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kelley A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ripper', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Paglisotti', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mulbah', 'Affiliation': ""UPMC Children's Hospital of Pittsburgh, Division of Adolescent and Young Adult Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.""}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': 'Division of General Internal Medicine, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2019.5217']
3112,30879470,Goal-oriented cognitive rehabilitation for early-stage Alzheimer's and related dementias: the GREAT RCT.,"BACKGROUND


Cognitive rehabilitation (CR) is an individualised, person-centred intervention for people with mild to moderate dementia that addresses the impact of cognitive impairment on everyday functioning.
OBJECTIVES


To determine whether or not CR is a clinically effective and cost-effective intervention for people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers.
DESIGN


This multicentre randomised controlled trial compared CR with treatment as usual (TAU). Following a baseline assessment and goal-setting to identify areas of everyday functioning that could be improved or better managed, participants were randomised (1 : 1) via secure web access to an independent randomisation centre to receive either TAU or CR and followed up at 3 and 9 months post randomisation.
SETTING


Community.
PARTICIPANTS


Participants had an  International Classification of Diseases , Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥ 18 points), were stable on medication if prescribed, and had a family carer who was willing to contribute. The exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English. To achieve adequate power, we needed 350 people to complete the trial, with 175 people in each trial arm.
INTERVENTION


Cognitive rehabilitation consisted of 10 therapy sessions over 3 months, followed by four maintenance sessions over 6 months, delivered in participants' homes. The therapists were nine occupational therapists and one nurse.
OUTCOME MEASURES


The primary outcome was self-reported goal attainment at 3 months. Goal attainment was also assessed at 9 months. Carers provided independent ratings of goal attainment at both time points. The secondary outcomes were participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life. The assessments at 3 and 9 months were conducted by researchers who were blind to the participants' group allocation.
RESULTS


A total of 475 participants were randomised (CR arm,  n  = 239; TAU arm,  n  = 236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm,  n  = 208, TAU arm,  n  = 218). At 3 months, there were statistically significant large positive effects for participant-rated goal attainment [mean change in the CR arm: 2.57; mean change in the TAU arm: 0.86; Cohen's d  = 0.97, 95% confidence interval (CI) 0.75 to 1.19], corroborated by carer ratings (Cohen's d  = 1.11, 95% CI 0.89 to 1.34). These effects were maintained at 9 months for both the participant ratings (Cohen's  d  = 0.94, 95% CI 0.71 to 1.17) and the carer ratings (Cohen's  d  = 0.96, 95% CI 0.73 to 1.20). There were no significant differences in the secondary outcomes. In the cost-utility analyses, there was no evidence of cost-effectiveness in terms of gains in the quality-adjusted life-years (QALYs) of the person with dementia (measured using the DEMentia Quality Of Life questionnaire utility score) or the QALYs of the carer (measured using the EuroQol-5 Dimensions, three-level version) from either cost perspective. In the cost-effectiveness analyses, by reference to the primary outcome of participant-rated goal attainment, CR was cost-effective from both the health and social care perspective and the societal perspective at willingness-to-pay values of £2500 and above for improvement in the goal attainment measure. There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.
LIMITATIONS


Possible limitations arose from the non-feasibility of using observational outcome measures, the lack of a general measure of functional ability and the exclusion of people without a carer or with rarer forms of dementia.
CONCLUSIONS


Cognitive rehabilitation is clinically effective in enabling people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy sessions.
FUTURE WORK


Next steps will focus on the implementation of CR into NHS and social care services and on extending the approach to people with rarer forms of dementia.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN21027481.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 10. See the NIHR Journals Library website for further project information.",2019,"There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.
","[""people with mild to moderate Alzheimer's disease or vascular or mixed dementia, and their carers"", 'exclusion criteria were people with a history of brain injury or other neurological disorder and an inability to speak English', ""Participants had an  International Classification of Diseases , Tenth Edition, diagnosis of Alzheimer's disease or vascular or mixed dementia, had mild to moderate cognitive impairment (Mini Mental State Examination score of ≥\u200918 points), were stable on medication if prescribed, and had a family carer who was willing to contribute"", '475 participants were randomised (CR arm,  n \u2009=\u2009239; TAU arm,  n \u2009=\u2009236), 427 participants (90%) completed the trial and 426 participants were analysed (CR arm,  n \u2009=\u2009208, TAU arm,  n \u2009=\u2009218', 'Community', '350 people to complete the trial, with 175 people in each trial arm', ""early-stage Alzheimer's and related dementias""]","['Goal-oriented cognitive rehabilitation', 'TAU or CR', 'CR', 'Cognitive rehabilitation (CR', 'Cognitive rehabilitation', 'Cognitive rehabilitation consisted of 10 therapy sessions']","['DEMentia Quality Of Life questionnaire utility score', 'participant quality of life, mood, self-efficacy and cognition, and carer stress, health status and quality of life', 'cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale', 'carer ratings', 'self-reported goal attainment', 'cost-effectiveness']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C3532942', 'cui_str': 'Dementia with mixed etiology'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0870733', 'cui_str': 'International Statistical Classification of Diseases and Related Health Problems'}, {'cui': 'C0205444', 'cui_str': 'Tenth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}]",475.0,0.233814,"There was no evidence on the cost-effectiveness of the self-efficacy measure (the Generalized Self-Efficacy Scale) from either cost perspective.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Clare', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Kudlicka', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jan R', 'Initials': 'JR', 'LastName': 'Oyebode', 'Affiliation': 'School of Dementia Studies, University of Bradford, Bradford, UK.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Jones', 'Affiliation': 'Research Institute for the Care of Older People (RICE), Bath, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, University Hospital Llandough, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Iracema', 'Initials': 'I', 'LastName': 'Leroi', 'Affiliation': 'Department of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kopelman', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, St Thomas' Hospital, King's College London, London, UK.""}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'James', 'Affiliation': 'Centre of the Health of the Elderly, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Culverwell', 'Affiliation': ""Kent and Medway NHS and Social Care Partnership Trust, St Martin's Hospital, Canterbury, UK.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Pool', 'Affiliation': 'Dementia Pal Ltd, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Hoare', 'Affiliation': 'North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Personal Social Services Research Unit, London School of Economics and Political Science, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Morgan-Trimmer', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': 'Department of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Corbett', 'Affiliation': 'Centre for Research in Ageing and Cognitive Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Whitaker', 'Affiliation': 'Whitaker Research Ltd, Bangor, UK.'}, {'ForeName': 'Bob', 'Initials': 'B', 'LastName': 'Woods', 'Affiliation': 'Dementia Services Development Centre, Bangor University, Bangor, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23100']
3113,32084353,Effect of Simvastatin on Bone Regeneration: A Histologic and Histomorphometric Analysis.,"PURPOSE


The purpose of the present study was to evaluate the efficacy of simvastatin administration as an osteoinductive agent combined with bovine bone material (BBM) for augmentation of human maxillary sinuses.
MATERIALS AND METHODS


In the present randomized clinical trial with a split-mouth design, 24 maxillary sinuses in 12 patients were augmented using BBM alone or BBM combined with simvastatin. Biopsy samples were taken 9 months after maxillary sinus floor augmentation for histologic and histomorphometric analyses. A total of 44 implants were placed in the augmented bone.
RESULTS


The results of the microscopic assessment of most samples revealed no inflammation or only mild chronic inflammation. Lamellation was detectable in old bone trabeculae under polarized light microscopy but was not observed in newly formed bone. Osteocytes were found with a lower frequency in the lacunae of newly formed bone compared with normal bone. No significant differences were found in the amount of newly formed bone and the amount of residual particles between the 2 groups.
CONCLUSIONS


Despite the greater mean percentage of newly formed bone in the test group, the histomorphometric analysis results did not show a significant positive effect for the use of simvastatin in maxillary sinus augmentation.",2020,"No significant differences were found in the amount of newly formed bone and the amount of residual particles between the 2 groups.
",['24 maxillary sinuses in 12 patients'],"['Simvastatin', 'BBM alone or BBM combined with simvastatin', 'bovine bone material (BBM', 'simvastatin']","['mild chronic inflammation', 'Bone Regeneration']","[{'cui': 'C0024957', 'cui_str': 'Maxillary Antrum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammatory reaction'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]",44.0,0.0474279,"No significant differences were found in the amount of newly formed bone and the amount of residual particles between the 2 groups.
","[{'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Yaghobee', 'Affiliation': 'Associate Professor, Department of Periodontology, Dental Implant Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Panjnoush', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Radiology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Chokami Rafiei', 'Affiliation': 'Assistant Professor, Department of Periodontology, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Pouyan', 'Initials': 'P', 'LastName': 'Amini Shakib', 'Affiliation': 'Assistant Professor, Department of Oral Pathology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Mahmoodi', 'Affiliation': 'PhD in Pharmaceutics, Private Practitioner, Tehran, Iran.'}, {'ForeName': 'Amir Ali Reza', 'Initials': 'AAR', 'LastName': 'Rasouli-Ghahroudi', 'Affiliation': 'Associate Professor, Department of Periodontology, Dental Implant Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Poursafar', 'Affiliation': 'Resident, Department of Periodontology, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: farzaneh.poursafar70@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.01.016']
3114,32176166,Feasibility of a trauma quality-of-life follow-up clinic.,"BACKGROUND


Little effort has been made to address long-term quality of life, chronic pain (CP), posttraumatic stress disorder (PTSD), and functional disability in trauma survivors. This quality initiative was developed to determine feasibility of a coordinated, comprehensive, patient-centered follow-up clinic for those at risk for poor long-term outcomes.
METHODS


A convenience sample from 649 hospitalized trauma patients at a Midwestern level 1 trauma center between February 2018 and August 2018 was screened for risk of PTSD and CP. Thirty-six patients were randomized into a standard follow-up clinic (standard of care [SOC]) (2-week postdischarge surgical clinic) or a new trauma quality of life clinic (TQOL). The TQOL was developed to provide comprehensive care to patients at high risk for PTSD (Injured Trauma Survivor Score, ≥2) and/or CP (discharge pain score, ≥4). Trauma quality of life clinic included a nurse practitioner or surgeon (physician), psychologist, social worker, and physical therapist at 1-week post discharge. All providers saw the patient independently, developed a care plan collaboratively, and communicated the plan to the patient. The SOC involved a visit only with a nurse practitioner or surgeon (medical doctor). Measures of pain, PTSD, depression, quality of life, physical functioning, and life satisfaction were completed at time of the TQOL/SOC or over the phone.
RESULTS


There were no differences in demographics, readmissions, or emergency department visits after discharge between groups. However, no show rates were almost twice as high in SOC (40%) compared with TQOL (22%) and those in TQOL completed 23 additional psychology visits versus one psychology visit in SOC. This clinic structure is feasible for high-risk patients, and TQOL patients demonstrated improved engagement in their care.
CONCLUSIONS


A comprehensive multidisciplinary TQOL addressing issues affecting convalescence for trauma patients at high risk for developing PTSD and CP can improve follow-up rates to ensure patients are recovering successfully.
LEVEL OF EVIDENCE


Therapeutic, Level IV.",2020,"There were no differences in demographics, readmissions, or emergency department visits after discharge between groups.","['trauma patients', '36 patients', '649 hospitalized trauma patients at a Midwestern level 1 trauma center between 2/2018 and 8/2018 was screened for risk of PTSD and CP', 'high risk patients and TQOL patients']","['standard follow-up clinic (SOC) (2-week post-discharge surgical clinic) or a new trauma quality of life clinic (TQOL', 'TQOL']","['TQOL included a nurse practitioner or surgeon(NP/MD), psychologist, social worker, and physical therapist', 'pain, PTSD, depression, QOL, physical functioning, and life satisfaction', 'demographics, readmissions, or emergency department visits']","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034380'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]",36.0,0.0384627,"There were no differences in demographics, readmissions, or emergency department visits after discharge between groups.","[{'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Trevino', 'Affiliation': 'From the Department of Surgery, Division of Trauma and Acute Care Surgery, Medical College of Wisconsin (C.T., T.G., D.J.M., P.C., T.d.-C.); Department of Psychology, Marquette University (S.C.T.-M.); and Froedtert Lutheran Memorial Hospital (M.S.), Milwaukee, Wisconsin.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Geier', 'Affiliation': ''}, {'ForeName': 'Sydney C', 'Initials': 'SC', 'LastName': 'Timmer-Murillo', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Shawlin', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Milia', 'Affiliation': ''}, {'ForeName': 'Panna', 'Initials': 'P', 'LastName': 'Codner', 'Affiliation': ''}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'deRoon-Cassini', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002672']
3115,32096120,Burst Suppression: Causes and Effects on Mortality in Critical Illness.,"BACKGROUND


Burst suppression in mechanically ventilated intensive care unit (ICU) patients is associated with increased mortality. However, the relative contributions of propofol use and critical illness itself to burst suppression; of burst suppression, propofol, and critical illness to mortality; and whether preventing burst suppression might reduce mortality, have not been quantified.
METHODS


The dataset contains 471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons. We used multiple prediction and causal inference methods to estimate the effects connecting burst suppression, propofol, critical illness, and in-hospital mortality in an observational retrospective study. We also estimated the effects mediated by burst suppression. Sensitivity analysis was used to assess for unmeasured confounding.
RESULTS


The expected outcomes in a ""counterfactual"" randomized controlled trial (cRCT) that assigned patients to mild versus severe illness are expected to show a difference in burst suppression burden of 39%, 95% CI [8-66]%, and in mortality of 35% [29-41]%. Assigning patients to maximal (100%) burst suppression burden is expected to increase mortality by 12% [7-17]% compared to 0% burden. Burst suppression mediates 10% [2-21]% of the effect of critical illness on mortality. A high cumulative propofol dose (1316 mg/kg) is expected to increase burst suppression burden by 6% [0.8-12]% compared to a low dose (284 mg/kg). Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
CONCLUSIONS


Our analysis clarifies how important factors contribute to mortality in ICU patients. Burst suppression appears to contribute to mortality but is primarily an effect of critical illness rather than iatrogenic use of propofol.",2020,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","['471 adults from seven ICUs, after excluding anoxic encephalopathy due to cardiac arrest or intentional burst suppression for therapeutic reasons', 'mechanically ventilated intensive care unit (ICU) patients', 'ICU patients']","['propofol', 'Propofol']","['burst suppression burden', 'mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0003132', 'cui_str': 'Anoxic Encephalopathy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0429306', 'cui_str': 'Burst suppression (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0609599,"Propofol exposure has no significant direct effect on mortality; its effect is entirely mediated through burst suppression.
","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Haoqi', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aboul Nour', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Tabaeizadeh', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Maryum', 'Initials': 'M', 'LastName': 'Shoukat', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Farrukh', 'Initials': 'F', 'LastName': 'Javed', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Solomon', 'Initials': 'S', 'LastName': 'Kassa', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Muhammad M', 'Initials': 'MM', 'LastName': 'Edhi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Bordbar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gallagher', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Valdery Moura', 'Initials': 'VM', 'LastName': 'Junior', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Ghanta', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Shao', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Akeju', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cole', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Sahar', 'Initials': 'S', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'M Brandon', 'Initials': 'MB', 'LastName': 'Westover', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. mwestover@mgh.harvard.edu.'}]",Neurocritical care,['10.1007/s12028-020-00932-4']
3116,31140666,The ironic effects of stigmatizing smoking: combining stereotype threat theory with behavioral pharmacology.,"AIMS


Public service announcements often create media messages intended to stigmatize negative behaviors to reduce and prevent these behaviors. Drawing on social and cognitive psychology, we hypothesize that stigmatizing messages can create stereotype threat would be associated with shorter latency to first cigarette in the laboratory compared to the control condition.
DESIGN


A double-blind, randomized, controlled trial in which participants completed two smoking lapse tasks, one at baseline and one post-intervention/control.
SETTING


An experimental psychopharmacology laboratory in the western United States.
PARTICIPANTS


A community sample of non-treatment-seeking daily smokers (n = 77) received either a stereotype threat (n = 39) or neutral/control (n = 38) message.
INTERVENTION


Participants received either a stereotype threat message that stigmatized smoking or a control message.
MEASUREMENTS


The primary outcome measure was participants' ability to delay smoking during the smoking lapse task in the experimental session FINDINGS: The difference in delay time during the experimental session at the point where 50% of each group had smoked was 3 minutes. Cox proportional hazard models revealed that participants in the stereotype threat group were significantly less able to delay initiating smoking compared to the control group (hazard ratio = 0.504, P = 0.010, 95% confidence interval = 0.30, 0.85), after controlling for baseline latency to smoke.
CONCLUSIONS


Messages that elicit negative stereotypes of smokers operated as 'smoking-promoting messages' in the context of our controlled laboratory investigation.",2019,"Cox proportional hazard models revealed that participants in the stereotype threat group were significantly less able to delay initiating smoking compared to the control group (HR = 0.504, p = .010, 95% CI [0.30, 0.85]), after controlling for baseline latency to smoke.
","['A community sample of non-treatment-seeking daily smokers (N=77) received either a', 'participants completed two smoking lapse tasks, one at baseline and one post intervention/control', 'An experimental psychopharmacology laboratory in the Western United States']","['stereotype threat (N=39) or neutral/control (N=38) message', 'stereotype threat message that stigmatized smoking or a control message']","['delay initiating smoking', 'delay time', ""participants' ability to delay smoking during the smoking lapse task""]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0033929', 'cui_str': 'Psychopharmacology'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0038272', 'cui_str': 'Stereotyping'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0834305,"Cox proportional hazard models revealed that participants in the stereotype threat group were significantly less able to delay initiating smoking compared to the control group (HR = 0.504, p = .010, 95% CI [0.30, 0.85]), after controlling for baseline latency to smoke.
","[{'ForeName': 'Clarissa I', 'Initials': 'CI', 'LastName': 'Cortland', 'Affiliation': 'Department of Psychology, The University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jenessa R', 'Initials': 'JR', 'LastName': 'Shapiro', 'Affiliation': 'Department of Psychology, The University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Iris Y', 'Initials': 'IY', 'LastName': 'Guzman', 'Affiliation': 'Department of Psychology, The University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, The University of California, Los Angeles, CA, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14696']
3117,31961420,Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial.,"Importance


Renal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation.
Objective


To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy.
Design, Setting, and Participants


The Evaluate Renal Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF) trial was an investigator-initiated, multicenter, single-blind, randomized clinical trial conducted at 5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany. A total of 302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018. Follow-up concluded in March 2019.
Interventions


Patients were randomized to either pulmonary vein isolation alone (n = 148) or pulmonary vein isolation plus renal denervation (n = 154). Complete pulmonary vein isolation to v an end point of elimination of all pulmonary vein potentials; renal denervation using an irrigated-tip ablation catheter delivering radiofrequency energy to discrete sites in a spiral pattern from distal to proximal in both renal arteries.
Main Outcomes and Measures


The primary end point was freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months. Secondary end points included procedural complications within 30 days and blood pressure control at 6 and 12 months.
Results


Of the 302 randomized patients (median age, 60 years [interquartile range, 55-65 years]; 182 men [60.3%]), 283 (93.7%) completed the trial. All successfully underwent their assigned procedures. Freedom from atrial fibrillation, flutter, or tachycardia at 12 months was observed in 84 of 148 (56.5%) of those undergoing pulmonary vein isolation alone and in 111 of 154 (72.1%) of those undergoing pulmonary vein isolation plus renal denervation (hazard ratio, 0.57; 95% CI, 0.38 to 0.85; P = .006). Of 5 prespecified secondary end points, 4 are reported and 3 differed between groups. Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001). Procedural complications occurred in 7 patients (4.7%) in the isolation-only group and 7 (4.5%) of the renal denervation group.
Conclusions and Relevance


Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months. The lack of a formal sham-control renal denervation procedure should be considered in interpreting the results of this trial.
Trial Registration


ClinicalTrials.gov Identifier: NCT01873352.",2020,"Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001).","[' 182 men [60.3%]), 283 (93.7%) completed the trial', '5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany', 'Patients With Paroxysmal Atrial Fibrillation and Hypertension', '302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018', '302 randomized patients (median age, 60 years [interquartile range, 55-65 years', 'patients with paroxysmal atrial fibrillation and hypertension']","['irrigated-tip ablation catheter delivering radiofrequency energy', 'pulmonary vein isolation alone (n\u2009=\u2009148) or pulmonary vein isolation plus renal denervation', 'catheter ablation alone', 'Renal Denervation and Catheter Ablation vs Catheter Ablation Alone', 'Catheter Ablation to Eliminate Atrial Fibrillation']","['Mean systolic blood pressure', 'freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months', 'Atrial Fibrillation Recurrence', 'likelihood of freedom from atrial fibrillation', 'Procedural complications', 'Freedom from atrial fibrillation, flutter, or tachycardia', 'procedural complications within 30 days and blood pressure control']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0037045', 'cui_str': 'Russian S.F.S.R., Asian'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0546959', 'cui_str': 'Atrial tachycardia (disorder)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1141861', 'cui_str': 'Periprocedural complication'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",302.0,0.123224,"Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, -13 mm Hg; 95% CI, -15 to -11 mm Hg; P < .001).","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Steinberg', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Heart Research Follow-up Program, Rochester, New York.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Shabanov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Losik', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Ivanickiy', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kropotkin', 'Affiliation': 'Federal Center of Cardiovascular Surgery, Krasnoyarsk, Russian Federation.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Polyakov', 'Affiliation': 'Federal Center of Cardiovascular Surgery, Khabarovosk, Russian Federation.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Ptaszynski', 'Affiliation': 'Medical University Lodz, Lodz, Poland.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Keweloh', 'Affiliation': 'Unfallkrankenhaus Berlin, Berlin, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Yao', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Heart Research Follow-up Program, Rochester, New York.'}, {'ForeName': 'Evgeny A', 'Initials': 'EA', 'LastName': 'Pokushalov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Romanov', 'Affiliation': 'E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}]",JAMA,['10.1001/jama.2019.21187']
3118,31895461,Association of Weekly Protected Nonclinical Time With Resident Physician Burnout and Well-being.,"Importance


Burnout among physicians is high, with resulting concern about quality of care. With burnout beginning early in physician training, much-needed data are lacking on interventions to decrease burnout and improve well-being among resident physicians.
Objectives


To design a departmental-level burnout intervention, evaluate its association with otolaryngology residents' burnout and well-being, and describe how residents used and perceived the study intervention.
Design, Setting, and Participants


A prospective, nonrandomized crossover study was conducted from September 25, 2017, to June 24, 2018, among all 19 current residents in the Department of Otolaryngology at the University of Minnesota. Statistical analysis was performed from June 28 to August 7, 2018.
Interventions


All participants were assigned 2 hours per week of protected nonclinical time alternating with a control period of no intervention at 6-week intervals.
Main Outcomes and Measures


Burnout was measured by the Maslach Burnout Inventory and Mini-Z Survey. Well-being was measured by the Resident and Fellow Well-Being Index and a quality-of-life single-item self-assessment. In addition to a baseline demographic survey, participants completed the aforementioned surveys at approximately 6-week intervals during the study period.
Results


Among the 19 residents in the study (10 men [53%]), the overall protected time intervention (week 0 to week 32) was associated with a mean decrease of 0.63 points (95% CI, -1.03 to -0.22 points) in the Maslach Burnout Inventory emotional exhaustion score, indicating a clinically meaningful decrease in burnout, and a mean decrease of 1.26 points (95% CI, -2.18 to -0.34 points) in the Resident and Fellow Well-Being Index score, indicating a clinically meaningful improvement in well-being. The baseline to week 32 mean changes in the Maslach Burnout Inventory depersonalization score, Maslach Burnout Inventory personal accomplishment score, and quality-of-life single-item self-assessment were not clinically meaningful. There were clinically meaningful improvements in 4 of 6 tested Mini-Z Questionnaire items from baseline to week 32: job stress (weighted κ statistic, 0.21; 95% CI, -0.11 to 0.53), burnout (weighted κ statistic, 0.25; 95% CI, -0.02 to 0.53), control over workload (weighted κ statistic, 0.26; 95% CI, -0.01 to 0.53), and sufficient time for documentation (weighted κ statistic, 0.31; 95% CI, 0.08 to 0.54).
Conclusions and Relevance


This study found that 2 hours per week of protected nonclinical time was associated with decreased burnout and increased well-being in a small sample of otolaryngology residents. Future randomized clinical studies in larger cohorts are warranted to infer causality of decreased burnout and increased well-being as a result of protected nonclinical time.",2020,"There were clinically meaningful improvements in 4 of 6 tested Mini-Z Questionnaire items from baseline to week 32: job stress (weighted κ statistic, 0.21; 95% CI, -0.11 to 0.53), burnout (weighted κ statistic, 0.25; 95% CI, -0.02 to 0.53), control over workload (weighted κ statistic, 0.26; 95% CI, -0.01 to 0.53), and sufficient time for documentation (weighted κ statistic, 0.31; 95% CI, 0.08 to 0.54).
","['September 25, 2017, to June 24, 2018, among all 19 current residents in the Department of Otolaryngology at the University of Minnesota']",[],"['Maslach Burnout Inventory emotional exhaustion score', 'Maslach Burnout Inventory depersonalization score, Maslach Burnout Inventory personal accomplishment score, and quality-of-life single-item self-assessment']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}]",[],"[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0034380'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment (Psychology)'}]",,0.0379207,"There were clinically meaningful improvements in 4 of 6 tested Mini-Z Questionnaire items from baseline to week 32: job stress (weighted κ statistic, 0.21; 95% CI, -0.11 to 0.53), burnout (weighted κ statistic, 0.25; 95% CI, -0.02 to 0.53), control over workload (weighted κ statistic, 0.26; 95% CI, -0.01 to 0.53), and sufficient time for documentation (weighted κ statistic, 0.31; 95% CI, 0.08 to 0.54).
","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Stevens', 'Affiliation': 'Department of Otolaryngology, University of Minnesota, Minneapolis.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Davey', 'Affiliation': 'Clinical and Translational Science Institute, Biostatistical Design and Analysis Center, University of Minnesota, Minneapolis.'}, {'ForeName': 'Amy Anne', 'Initials': 'AA', 'LastName': 'Lassig', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Minneapolis.'}]",JAMA otolaryngology-- head & neck surgery,['10.1001/jamaoto.2019.3654']
3119,31164362,Can goal-setting for patients with multimorbidity improve outcomes in primary care? Cluster randomised feasibility trial.,"INTRODUCTION


Goal-setting is recommended for patients with multimorbidity, but there is little evidence to support its use in general practice.
OBJECTIVE


To assess the feasibility of goal-setting for patients with multimorbidity, before undertaking a definitive trial.
DESIGN AND SETTING


Cluster-randomised controlled feasibility trial of goal-setting compared with control in six general practices.
PARTICIPANTS


Adults with two or more long term health conditions and at risk of unplanned hospital admission.
INTERVENTIONS


General practitioners (GPs) underwent training and patients were asked to consider goals before an initial goal-setting consultation and a follow-up consultation 6 months later. The control group received usual care planning.
OUTCOME MEASURES


Health-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use. All consultations were video-recorded or audio-recorded, and focus groups were held with participating GPs and patients.
RESULTS


Fifty-two participants were recruited with a response rate of 12%. Full follow-up data were available for 41. In the goal-setting group, mean age was 80.4 years, 54% were female and the median number of prescribed medications was 13, compared with 77.2 years, 39% female and 11.5 medications in the control group. The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group. Overall 28% of patient participants had no cognitive impairment. Participants set between one and three goals on a wide range of subjects, such as chronic disease management, walking, maintaining social and leisure interests, and weight management. Patient participants found goal-setting acceptable and would have liked more frequent follow-up. GPs unanimously liked goal-setting and felt it delivered more patient-centred care, and they highlighted the importance of training.
CONCLUSIONS


This goal-setting intervention was feasible to deliver in general practice. A larger, definitive study is needed to test its effectiveness.
TRIAL REGISTRATION NUMBER


ISRCTN13248305; Post-results.",2019,The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group.,"['Adults with two or more long term health conditions and at risk of unplanned hospital admission', 'six general practices', 'patients with multimorbidity', 'Fifty-two participants were recruited with a response rate of 12', 'patients with multimorbidity, before undertaking a definitive trial', 'mean age was 80.4 years, 54% were female and the median number of prescribed medications was 13, compared with 77.2 years, 39% female and 11.5 medications in the control group', 'Participants set between one and three goals on a wide range of subjects, such as chronic disease management, walking, maintaining social and leisure interests, and weight management']",['usual care planning'],"['cognitive impairment', 'Health-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use', 'mean initial consultation time']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444864', 'cui_str': 'AM 13 (qualifier value)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",52.0,0.108989,The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group.,"[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Ford', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lenaghan', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Salter', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Shiner', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Murdoch', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Patient and public involvement representative, Norwich, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Koopmans', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Lipp', 'Affiliation': 'NHS England Midlands & East (East), Fulbourn, UK.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'Patient and public involvement representative, Norwich, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wade', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Winterburn', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Steel', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}]",BMJ open,['10.1136/bmjopen-2018-025332']
3120,32068484,"International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR.","PURPOSE


We assessed efficacy, safety and tolerability of vibegron, a novel, potent, highly selective β 3 -adrenoceptor agonist, administered 12 weeks at 75 mg once daily to patients with overactive bladder in an international phase III trial with placebo and active control.
MATERIALS AND METHODS


Adult patients with overactive bladder with 8.0 or more micturitions per day were randomized 5:5:4 to 75 mg vibegron, placebo or extended-release 4 mg extended-release tolterodine. Up to 25% of patients could have dry overactive bladder (less than 1.0 urge incontinence episode per day). Patients completed 7-day voiding diaries at baseline and weeks 2, 4, 8 and 12.
RESULTS


Of 1,518 randomized patients 90.4% completed the trial. At 12 weeks micturitions decreased by an adjusted mean of 1.8 episodes per day for vibegron vs 1.3 for placebo (p <0.001, co-primary end point) and 1.6 for tolterodine. Among incontinent patients urge incontinence episodes decreased by an adjusted mean 2.0 episodes per day for vibegron vs 1.4 for placebo (p <0.0001, co-primary end point) and 1.8 for tolterodine. Moreover, vibegron was statistically significantly superior to placebo for key secondary measures of number of urgency episodes, volume per micturition and proportion of incontinent patients with a 75% or greater reduction in urge incontinence episodes (all p <0.01). Among vibegron treated patients 1.7% discontinued treatment because of adverse events vs 1.1% for placebo and 3.3% for tolterodine. Incidence of hypertension was 1.7% for vibegron and for placebo.
CONCLUSIONS


Once daily 75 mg vibegron provided statistically significant reductions in micturitions, urgency episodes and urge incontinence, and increased the volume per micturition. Treatment was well tolerated with a favorable safety profile.",2020,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","['Adult patients with overactive bladder with ≥8.0 micturitions/day', 'Patients with Symptoms of Overactive Bladder', 'patients with overactive bladder in an international phase III trial with']","['vibegron 75 mg, placebo, or extended-release tolterodine 4 mg', 'Vibegron', 'placebo', 'placebo and active control', 'tolterodine', 'Placebo']","['efficacy, safety, and tolerability', 'number of urgency episodes, volume per micturition', 'Safety and Efficacy', '7-day voiding diaries', 'micturitions, urgency episodes, urge incontinence, and increased the volume per micturition', 'adverse events', 'urge-incontinence episodes', 'Incidence of hypertension', 'dry overactive bladder']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0388753', 'cui_str': 'tolterodine'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]",1518.0,0.512834,"CONCLUSIONS


Once-daily vibegron 75 mg provided statistically significant reductions in micturitions, urgency episodes, urge incontinence, and increased the volume per micturition.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Staskin', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Frankel', 'Affiliation': 'Seattle Urology Research Center, Seattle, Washington.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Varano', 'Affiliation': 'Clinical Research Consulting, Milford, Connecticut.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Shortino', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Jankowich', 'Affiliation': 'Urovant Sciences, Irvine, California.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Mudd', 'Affiliation': 'Urovant Sciences, Irvine, California.'}]",The Journal of urology,['10.1097/JU.0000000000000807']
3121,31268629,Resolute zotarolimus-eluting stent in ST-elevation myocardial infarction (resolute-STEMI): A prespecified prospective register from the DAPT-STEMI trial.,"OBJECTIVES


To evaluate the safety and efficacy outcomes after primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES) in patients enrolled in the DAPT-STEMI Trial (NCT01459627).
BACKGROUND


R-ZES is one of the most used drug eluting stents worldwide. To date, the safety and efficacy data of this stent in setting of STEMI is limited.
METHODS


The Resolute-STEMI is a prespecified prospective register that reports the safety and efficacy of R-ZES in setting of ST-Elevation Myocardial Infarction (STEMI) at 6 months for the following endpoints: a composite endpoint of all-cause mortality, any myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST).
RESULTS


From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES. At 6 months the PE occurred in 42 (4.2%) patients. All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%). The rate of target lesion revascularizations involving the culprit lesion was 1.1%. Target lesion failure was 1.5%. The rate of definite ST was 0.5%. The rate of both definite or probable ST was 0.7%.
CONCLUSIONS


The present analysis is the largest to date reporting short-term and mid-term clinical outcomes with the R-ZES stent in setting of STEMI. At 30 days and 6-months R-ZES has an outstanding safety and efficacy even in this high-risk category of patients.",2020,"All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%).","['patients enrolled in the DAPT-STEMI Trial (NCT01459627', 'From a total of 1,100 STEMI patients enrolled in the trial, 998 received a R-ZES']","['Resolute zotarolimus-eluting stent', 'primary percutaneous coronary intervention (pPCI) with second-generation Resolute™ zotarolimus-eluting stent (R-ZES']","['PE', 'safety and efficacy outcomes', 'rate of definite ST', 'rate of target lesion revascularizations', 'myocardial infarction (MI), any (unscheduled) revascularization, stroke and TIMI major bleeding, as well as target lesion failure and stent thrombosis (ST', 'All-cause death, MI, revascularization, stroke and TIMI major bleeding', 'rate of both definite or probable ST', 'Target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1700035', 'cui_str': 'zotarilumus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",1100.0,0.0478449,"All-cause death, MI, revascularization, stroke and TIMI major bleeding was respectively 8 (0.8%), 9 (0.8%), 34 (3.4%), 2 (0.2%), and 4 (0.4%).","[{'ForeName': 'Warner', 'Initials': 'W', 'LastName': 'Postma', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fabris', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Van der Ent', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Hermanides', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Ustroń, Poland.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Von Birgelen C', 'Affiliation': 'Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, the Netherlands.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University and Hospital, Fribourg, Switzerland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wedel', 'Affiliation': 'Sahlgrenska Academy, University of Gothenburg and Nordic School of Public Health, Gothenburg, Sweden.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'Department of Cardiology, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Heart Centre, Academic Medical Centre, University Medical Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, the Netherlands.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28376']
3122,31042143,Therapist telephone-delivered CBT and web-based CBT compared with treatment as usual in refractory irritable bowel syndrome: the ACTIB three-arm RCT.,"BACKGROUND


Irritable bowel syndrome (IBS) affects 10-22% of people in the UK. Abdominal pain, bloating and altered bowel habits affect quality of life and can lead to time off work. Current treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many people suffer ongoing symptoms. Cognitive-behavioural therapy (CBT) is recommended in guidelines for patients with ongoing symptoms but its availability is limited.
OBJECTIVES


To determine the clinical effectiveness and cost-effectiveness of therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT) with minimal therapist support compared with treatment as usual (TAU) in refractory IBS.
DESIGN


This was a three-arm randomised controlled trial.
SETTING


This trial took place in UK primary and secondary care.
PARTICIPANTS


Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016.
INTERVENTIONS


TCBT - patient CBT self-management manual, six 60-minute telephone sessions over 9 weeks and two 60-minute booster sessions at 4 and 8 months (8 hours' therapist time). WCBT - interactive, tailored web-based CBT, three 30-minute telephone sessions over 9 weeks and two 30-minute boosters at 4 and 8 months (2.5 hours' therapist time).
MAIN OUTCOME MEASURES


Primary outcomes - IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS) at 12 months. Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs].
RESULTS


In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited - 186 were randomised to TCBT, 185 were randomised to WCBT and 187 were randomised to TAU. The mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) was 265.0. An intention-to-treat analysis with multiple imputation was carried out at 12 months; IBS SSS were 61.6 points lower in the TCBT arm [95% confidence interval (CI) 89.5 to 33.8;  p  < 0.001] and 35.2 points lower in the WCBT arm (95% CI 57.8 to 12.6;  p  = 0.002) than in the TAU arm (IBS SSS of 205.6). The mean WSAS score at 12 months was 10.8 in the TAU arm, 3.5 points lower in the TCBT arm (95% CI 5.1 to 1.9;  p  < 0.001) and 3.0 points lower in the WCBT arm (95% CI 4.6 to 1.3;  p  = 0.001). For the secondary outcomes, the Subject's Global Assessment showed an improvement in symptoms at 12 months (responders) in 84.8% of the TCBT arm compared with 41.7% of the TAU arm [odds ratio (OR) 6.1, 95% CI 2.5 to 15.0;  p  < 0.001] and 75.0% of the WCBT arm (OR 3.6, 95% CI 2.0 to 6.3;  p  < 0.001). Patient enablement was 78.3% (responders) for TCBT, 23.5% for TAU (OR 9.3, 95% CI 4.5 to 19.3;  p  < 0.001) and 54.8% for WCBT (OR 3.5, 95% CI 2.0 to 5.9;  p  < 0.001). Adverse events were similar between the trial arms. The incremental cost-effectiveness ratio (ICER) (QALY) for TCBT versus TAU was £22,284 and for WCBT versus TAU was £7724. Cost-effectiveness reduced after imputation for missing values. Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life. Therapist input was important in supporting WCBT.
CONCLUSIONS


In this large, rigorously conducted RCT, both CBT arms showed significant improvements in IBS outcomes compared with TAU. WCBT had lower costs per QALY than TCBT. Sustained improvements in IBS symptoms are possible at an acceptable cost. Suggested future research work is longer-term follow-up and research to translate these findings into usual clinical practice.
FUTURE WORK


Longer-term follow-up and research to translate these findings into usual clinical practice is needed.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN44427879.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 17. See the NIHR Journals Library website for further project information. The University of Southampton sponsored this study. Funding was received from the NIHR HTA Board and the NIHR Clinical Research Network and support was received from the NIHR Clinical Research Network.",2019,"Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life.","['patients with ongoing symptoms', 'In total, 558 out of 1452 patients (38.4%) screened for eligibility were recruited - 186 were randomised to', 'Adults with refractory IBS (clinically significant symptoms for 12 months despite first-line therapies) were recruited from 74 general practices and three gastroenterology centres from May 2014 to March 2016']","['TCBT', 'Cognitive-behavioural therapy (CBT', 'WCBT', 'Therapist telephone-delivered CBT and web-based CBT', 'therapist telephone-delivered CBT (TCBT) and web-based CBT (WCBT', 'TAU', 'Health Technology Assessment (HTA) programme']","['Abdominal pain, bloating and altered bowel habits affect quality of life', ' IBS symptom severity score (IBS SSS) and Work and Social Adjustment Scale (WSAS', 'Adverse events', 'capacity to cope with symptoms, negative emotions and challenges of daily life', 'mean baseline Irritable Bowel Syndrome Symptom Severity Score (IBS SSS', 'IBS outcomes', 'Cost-effectiveness [quality-adjusted life-years (QALYs) and health-care costs', 'IBS symptoms', 'incremental cost-effectiveness ratio (ICER) (QALY', 'Cost-effectiveness', 'mean WSAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0039423', 'cui_str': 'Technology Assessment, Health'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",1452.0,0.212964,"Qualitative findings highlighted that, in the CBT arms, there was increased capacity to cope with symptoms, negative emotions and challenges of daily life.","[{'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Everitt', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Bishop', 'Affiliation': 'Centre for Applications of Health Psychology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': ""O'Reilly"", 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': ""Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Sula', 'Initials': 'S', 'LastName': 'Windgassen', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Goldsmith', 'Affiliation': ""Biostatistics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Coleman', 'Affiliation': 'Department of Gastroenterology, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Logan', 'Affiliation': ""Department of Gastroenterology, King's College Hospital, London, UK.""}, {'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Health Psychology Section, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}]","Health technology assessment (Winchester, England)",['10.3310/hta23170']
3123,32046499,"App-based mindfulness meditation for psychological distress and adjustment to college in incoming university students: a pragmatic, randomised, waitlist-controlled trial.","Objective and Design:  In a pragmatic, randomised, waitlist-controlled trial we tracked 250 first-year university students who were randomly assigned to 3 months of a mindfulness meditation app (Headspace) to use at their discretion in either semester 1 (intervention,  n  = 124) or semester 2 (waitlist,  n  = 126).  Main Outcome Measures:  Students reported their distress, college adjustment, resilience, self-efficacy, and mindfulness, at 3 timepoints: the beginning of semester 1, the beginning of semester 2, and the end of the academic year. With participants' permission, the university provided academic achievement data and Headspace provided app use data.  Results:  Evidence for improvements in distress at the beginning of semester 2 was weak (intervention vs. waitlist) and app use was low ( M  = 7.91, SD = 15.16 sessions). Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users. App initiation and persistence beyond the first week was higher when the app was provided in semester 1 than semester 2 (66.1% vs. 44.4%; 46.0% vs. 32.5%).  Conclusion:  Headspace use was associated with small improvements in distress and college adjustment in first-year university students. Intervening at the beginning of the academic year may encourage uptake.",2020,"Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users.","['psychological distress and adjustment to college in incoming university students', '250 first-year university students']","['App-based mindfulness meditation', 'mindfulness meditation app (Headspace) to use at their discretion in either semester 1 (intervention,  n \u2009=\u2009124) or semester 2 (waitlist,  n \u2009=\u2009126']","['psychological distress', 'distress, college adjustment, resilience, self-efficacy, and mindfulness', 'distress']","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",250.0,0.0485816,"Nevertheless, intervention participants who used the app more frequently reported improvements in psychological distress (-5 points, R 2  change = .12) and college adjustment (+10 points, R 2  change = .09) when compared to non-users.","[{'ForeName': 'Jayde A M', 'Initials': 'JAM', 'LastName': 'Flett', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tamlin S', 'Initials': 'TS', 'LastName': 'Conner', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Riordan', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Patterson', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Harlene', 'Initials': 'H', 'LastName': 'Hayne', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}]",Psychology & health,['10.1080/08870446.2019.1711089']
3124,31289075,Implementation of the Symptom Navi © Programme for cancer patients in the Swiss outpatient setting: a study protocol for a cluster randomised pilot study (Symptom Navi© Pilot Study).,"INTRODUCTION


Self-management interventions show promising results on symptom outcomes and self-management behaviours. The Symptom Navi© Programme (SN©P) is a nurse-led intervention supporting patients' symptom self-management during anticancer treatment. It consists of written patient information (Symptom Navi© Flyers (SN©Flyers)), semistructured consultations and a training manual for nurses.
METHODS AND ANALYSIS


This pilot study will evaluate the implementation of the SN©P based on the Reach Effectiveness-Adoption Implementation Maintenance framework at Swiss outpatient cancer centres. We will use a cluster-randomised design and randomise the nine participating centres to the intervention or usual care group. We expect to include 140 adult cancer patients receiving first-line systemic anticancer treatment. Trained nurses at the intervention clusters will provide at least two semistructured consultations with the involvement of SN©Flyers. Outcomes include patients' accrual and retention rates, patient-reported interference of symptoms with daily functions, symptom burden, perceived self-efficacy, quality of nursing care, nurse-reported facilitators and barriers of adopting the programme, nurses' fidelity of providing the intervention as intended, and patients' safety (patients timely reporting of severe symptoms). We will use validated questionnaires for patient-reported outcomes, focus group interviews with nurses and individual interviews with oncologists. Linear mixed models will be used to analyse patient-reported outcomes. Focus group and individual interviews will be analysed by thematic analysis.
ETHICS AND DISSEMINATION


The Symptom Navi© Pilot Study has been reviewed and approved by Swiss Ethic Committee Bern (KEK-BE: 2017-00020). Results of the study will be disseminated in peer-reviewed journal and at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03649984; Pre-results.",2019,The Symptom Navi© Programme (SN©P) is a nurse-led intervention supporting patients' symptom self-management during anticancer treatment.,"['cancer patients in the Swiss outpatient setting', '140 adult cancer patients receiving first-line systemic anticancer treatment', 'Swiss outpatient cancer centres']",['Symptom Navi © Programme'],"[""patients' accrual and retention rates, patient-reported interference of symptoms with daily functions, symptom burden, perceived self-efficacy, quality of nursing care, nurse-reported facilitators and barriers of adopting the programme, nurses' fidelity of providing the intervention as intended, and patients' safety (patients timely reporting of severe symptoms""]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",140.0,0.0706245,The Symptom Navi© Programme (SN©P) is a nurse-led intervention supporting patients' symptom self-management during anticancer treatment.,"[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Bana', 'Affiliation': 'HedS-FR School of Health Sciences, University of Applied Science and Arts Western Switzerland, Fribourg, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': 'IUFRS Institut de formation et de recherche en soins, Université de Lausanne Faculté de biologie et médecine, Lausanne, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Kropf-Staub', 'Affiliation': 'Fachentwicklung Pflege, Lindenhofgruppe, Bern, Switzerland.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Zürcher-Florin', 'Affiliation': 'Fachentwicklung Pflege, Lindenhofgruppe, Bern, Switzerland.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Näf', 'Affiliation': 'Department of Practice Development in Nursing, Solothurner Spitaler AG, Solothurn, Switzerland.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Manser', 'Affiliation': 'FHNW School of Applied Psychology, University of Applied Sciences and Arts Northwestern Switzerland, Olten, Switzerland.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Bütikofer', 'Affiliation': 'CTU, Universität Bern, Bern, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Rintelen', 'Affiliation': 'CTU, Universität Bern, Bern, Switzerland.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Departement of Oncology, CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Eicher', 'Affiliation': 'IUFRS Institut de formation et de recherche en soins, Université de Lausanne Faculté de biologie et médecine, Lausanne, Switzerland.'}]",BMJ open,['10.1136/bmjopen-2018-027942']
3125,32144378,"Changes in body weight, adherence, and appetite during 2 years of calorie restriction: the CALERIE 2 randomized clinical trial.","BACKGROUND/OBJECTIVES


The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE) study showed that individuals who are nonobese were able to undergo significant calorie restriction (CR), yet the time course changes in adherence, weight, and appetite are unknown. This analysis aimed to investigate the time course changes in adherence, body weight, and appetite during the CALERIE study.
SUBJECTS/METHODS


Overall, 143 participants (body mass index: 21.9-28.0 kg/m 2 ) were randomized to a CR group that aimed to achieve 25% CR for 2 years. Throughout the intervention, body weight was measured, and appetite was assessed through visual analogue scales. Algorithms were utilized with body weight measurements to calculate adherence percentile score. Participants targeted an adherence percentile score of 50, though being between 80 (lowest acceptable adherence) and 10 (highest acceptable adherence) was adequate. Polynomial regression analyses were used to assess time course changes.
RESULTS


Polynomials indicated that adherence percentile score increased above 50 after approximately week 20, although adherence remained acceptable (adherence percentile score less than 80) (R 2  = 0.89; P < 0.001). Weight loss occurred until approximately week 60 and then plateaued (R 2  ≥ 0.92; P < 0.001). Hunger and thirst increased (R 2  ≥ 0.30; P < 0.001), but the total increase in scale scores were <10 mm throughout the intervention.
CONCLUSIONS


In individuals who are nonobese, adherence to 25% CR declines after 20 weeks, but 2 years of CR that stimulates a meaningful reduction in weight, promotes aging-related benefits and negligibly affects appetite is viable.",2020,"Hunger and thirst increased (R 2  ≥ 0.30; P < 0.001), but the total increase in scale scores were <10 mm throughout the intervention.
","['individuals who are nonobese', '143 participants (body mass index: 21.9-28.0\u2009kg/m 2 ']",[],"['body weight', 'Weight loss', 'total increase in scale scores', 'body weight, adherence, and appetite', 'adherence, body weight, and appetite', 'adherence percentile score']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",143.0,0.0561506,"Hunger and thirst increased (R 2  ≥ 0.30; P < 0.001), but the total increase in scale scores were <10 mm throughout the intervention.
","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St, Boston, MA, 02111, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Washington University School of Medicine, 4444 Forest Park Ave., St. Louis, MO, 63108, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke University Medical Center, 10 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd, Baton Rouge, LA, 70808, USA. Corby.Martin@pbrc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of clinical nutrition,['10.1038/s41430-020-0593-8']
3126,32144884,Racial differences in pain and function following knee arthroplasty: A secondary analysis from a multicenter randomized clinical trial.,"OBJECTIVE


The assessment of racial differences in pain and function outcome following knee arthroplasty has received little attention in spite of a very substantial literature exploring a variety of other prognostic factors. We determined whether race associated with knee arthroplasty (KA) outcome after accounting for potential confounding factors.
METHODS


We conducted a secondary analysis of a randomized clinical trial of 384 participants with moderate to high pain catastrophizing who underwent knee arthroplasty. Preoperative measures included race/ethnicity status as well as a variety of potential confounders including socioeconomic status, comorbidity and bodily pain. Outcome measures were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function Scales as well as performance measures. Linear mixed effects models compared outcomes over a one-year follow-up for African Americans versus the non-African Americans.
RESULTS


WOMAC Pain scores differences for African Americans versus non-African Americans averaged approximately 2 points in unadjusted analyses and 1 to 1.5 points in adjusted analyses. In adjusted analyses, follow-up WOMAC Function scores differed by 6 points for African Americans compared to non-African Americans (p = 0.002).
CONCLUSION


",2020,"RESULTS


WOMAC Pain scores differences for African Americans versus non-African Americans averaged approximately 2 points in unadjusted analyses and 1 to 1.5 points in adjusted analyses.","['384 participants with moderate to high pain catastrophizing who underwent knee arthroplasty', 'African Americans versus the non-African Americans', 'knee arthroplasty', 'African Americans versus non-African Americans']",[],"['socioeconomic status, comorbidity and bodily pain', 'pain and function', 'Western Ontario and McMaster Universities Osteoarthritis Index', 'WOMAC) Pain and Function Scales', 'WOMAC Function scores']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",[],"[{'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",384.0,0.21899,"RESULTS


WOMAC Pain scores differences for African Americans versus non-African Americans averaged approximately 2 points in unadjusted analyses and 1 to 1.5 points in adjusted analyses.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Riddle', 'Affiliation': 'Departments of Physical Therapy, Orthopaedic Surgery and Rheumatology, Virginia Commonwealth University, Richmond, VA, 23298-0224.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Slover', 'Affiliation': 'Department of Orthopaedic Surgery, New York University Medical Center, New York, New York, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Pain Prevention and Treatment Research, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Ang', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Dumenci', 'Affiliation': 'Department of Epidemiology and Biostatistics, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Perera', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}]",Arthritis care & research,['10.1002/acr.24177']
3127,32046597,The Countervailing Effects of Weight Stigma on Weight-Loss Motivation and Perceived Capacity for Weight Control.,"We hypothesized that exposure to weight stigma simultaneously  increases  motivation to lose or avoid gaining weight to avoid future stigma and  decreases  perceived capacity to do so, by heightening concerns about experiencing stigma and negative affect. Study 1 showed that more frequently experiencing weight-based discrimination was associated with greater concerns about being a victim of weight stigma, which predicted increased motivation to lose weight but decreased perceived capacity for weight control. Study 2 showed that participants randomly assigned to view a weight-stigmatizing (vs. control) message showed increased concerns about being a target of weight stigma, which indirectly increased motivation to lose weight and decreased state self-control. These, in turn, predicted increased willingness to engage in unhealthy weight-loss behaviors and decreased perceived capacity for weight control, respectively. Study 3 showed that increased motivation to avoid stigma and increased negative affect mediate these effects of exposure to weight stigma.",2020,"Study 1 showed that more frequently experiencing weight-based discrimination was associated with greater concerns about being a victim of weight stigma, which predicted increased motivation to lose weight but decreased perceived capacity for weight control.",[],[],['willingness to engage in unhealthy weight-loss behaviors'],[],[],"[{'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0203034,"Study 1 showed that more frequently experiencing weight-based discrimination was associated with greater concerns about being a victim of weight stigma, which predicted increased motivation to lose weight but decreased perceived capacity for weight control.","[{'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Major', 'Affiliation': 'University of California, Santa Barbara, USA.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'Rathbone', 'Affiliation': 'The University of Queensland, St Lucia, Australia.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blodorn', 'Affiliation': 'University of California, Santa Barbara, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Hunger', 'Affiliation': 'Miami University, Oxford, OH, USA.'}]",Personality & social psychology bulletin,['10.1177/0146167220903184']
3128,31032782,A group memory rehabilitation programme for people with traumatic brain injuries: the ReMemBrIn RCT.,"BACKGROUND


People with traumatic brain injuries (TBIs) commonly report memory impairments. These are persistent, debilitating and reduce quality of life, but patients do not routinely receive memory rehabilitation after discharge from hospital.
OBJECTIVE


To assess the clinical effectiveness and cost-effectiveness of a group memory rehabilitation programme for people with TBI.
DESIGN


Multicentre, pragmatic, cluster randomised controlled trial. Qualitative and health economic evaluations were also undertaken.
SETTING


Community settings in nine sites in England.
PARTICIPANTS


Participants were aged 18-69 years, had undergone a TBI > 3 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent.
RANDOMISATION AND BLINDING


Clusters of four to six participants were randomised to the memory rehabilitation arm or the usual-care arm on a 1 : 1 ratio. Randomisation was based on a computer-generated pseudo-random code using random permuted blocks of randomly varying size, stratified by study site. Participants and therapists were aware of the treatment allocation whereas outcome assessors were blinded.
INTERVENTIONS


In the memory rehabilitation arm 10 weekly sessions of a manualised memory rehabilitation programme were provided in addition to usual care. Participants were taught restitution strategies to retrain impaired memory functions and compensation strategies to enable them to cope with memory problems. The usual-care arm received usual care only.
MAIN OUTCOME MEASURES


Outcomes were assessed at 6 and 12 months after randomisation. Primary outcome: patient-completed Everyday Memory Questionnaire - patient version (EMQ-p) at 6 months' follow-up. Secondary outcomes: Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment. Costs (based on a UK NHS and Personal Social Services perspective) were collected using a service use questionnaire, with the EuroQol-5 Dimensions, five-level version, used to derive quality-adjusted life-years (QALYs). A Markov model was developed to explore cost-effectiveness at 5 and 10 years, with a 3.5% discount applied.
RESULTS


We randomised 328 participants (memory rehabilitation,  n  = 171; usual care,  n  = 157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis. We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5;  p  = 0.37). For secondary outcomes, differences favouring the memory rehabilitation arm were observed at 6 months' follow-up for the RBMT-3 and goal attainment, but remained only for goal attainment at 12 months' follow-up. There were no differences between arms in mood or quality of life. The qualitative results suggested positive experiences of participating in the trial and of attending the groups. Participants reported that memory rehabilitation was not routinely accessible in usual care. The primary health economics outcome at 12 months found memory rehabilitation to be £26.89 cheaper than usual care but less effective, with an incremental QALY loss of 0.007. Differences in costs and effects were not statistically significant and non-parametric bootstrapping demonstrated considerable uncertainty in these findings. No safety concerns were raised and no deaths were reported.
LIMITATIONS


As a pragmatic trial, we had broad inclusion criteria and, therefore, there was considerable heterogeneity within the sample. The study was not powered to perform further subgroup analyses. Participants and therapists could not be blinded to treatment allocation.
CONCLUSIONS


The group memory rehabilitation delivered in this trial is very unlikely to lead to clinical benefits or to be a cost-effective treatment for people with TBI in the community. Future studies should examine the selection of participants who may benefit most from memory rehabilitation.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN65792154.
FUNDING


This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 23, No. 16. See the NIHR Journals Library website for further project information.",2019,"We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5;  p  = 0.37).","['Participants were aged 18-69 years, had undergone a TBI >\u20093 months prior to recruitment, reported memory problems, were able to travel to a site to attend group sessions, could communicate in English and gave informed consent', 'Community settings in nine sites in England', 'people with TBI', 'people with traumatic brain injuries', '328 participants (memory rehabilitation,  n \u2009=\u2009171; usual care,  n \u2009=\u2009157), with 129 in the memory rehabilitation arm and 122 in the usual-care arm included in the primary analysis', 'participants who may benefit most from memory rehabilitation', 'People with traumatic brain injuries (TBIs']","['memory rehabilitation arm or the usual-care arm on a 1\u2009:\u20091 ratio', 'memory rehabilitation programme', 'group memory rehabilitation programme', 'manualised memory rehabilitation programme', 'usual care only']","['patient-completed Everyday Memory Questionnaire - patient version (EMQ-p', 'memory rehabilitation', 'Rivermead Behavioural Memory Test - third edition (RBMT-3), General Health Questionnaire 30-item version, European Brain Injury Questionnaire, Everyday Memory Questionnaire - relative version and individual goal attainment', 'clinical effectiveness and cost-effectiveness', 'mood or quality of life', 'cost-effectiveness']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0588977', 'cui_str': 'Everyday memory questionnaire (assessment scale)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4273837', 'cui_str': 'RBMT-3 - Rivermead Behavioral Memory Test-Third Edition'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire (assessment scale)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}]",328.0,0.128157,"We found no clinically important difference on the EMQ-p between the two arms at 6 months' follow-up (adjusted difference in mean scores -2.1, 95% confidence interval -6.7 to 2.5;  p  = 0.37).","[{'ForeName': 'Roshan', 'Initials': 'R', 'LastName': 'das Nair', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lucy E', 'Initials': 'LE', 'LastName': 'Bradshaw', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Carpenter', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Day', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Fitzsimmons', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Swansea Centre for Health Economics, Swansea University, Swansea, UK.'}, {'ForeName': 'Alan A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Newby', 'Affiliation': 'Newby Psychological Services Ltd, Northwich, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sackley', 'Affiliation': ""Division of Health and Social Care, King's College London, London, UK.""}, {'ForeName': 'Nadina B', 'Initials': 'NB', 'LastName': 'Lincoln', 'Affiliation': 'Division of Rehabilitation and Ageing, University of Nottingham, Nottingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta23160']
3129,30801612,Effect of a Breakfast in the Classroom Initiative on Obesity in Urban School-aged Children: A Cluster Randomized Clinical Trial.,"Importance


Serving breakfast in the classroom is promoted to increase participation in the federal School Breakfast Program. However, little is known about the effect of breakfast in the classroom on children's weight status.
Objective


To evaluate the effect of a breakfast in the classroom initiative, which combined breakfast in the classroom with breakfast-specific nutrition education, on overweight and obesity among urban children in low-income communities.
Design, Setting, and Participants


A cluster-randomized clinical trial among 1362 fourth- through sixth-grade students from low-income urban communities across 2.5 years. Sixteen kindergarten through eighth grade Philadelphia public schools with universal breakfast participated. Participants were recruited in September 2013, and the intervention began in January 2014. Data analysis took place from April 1, 2018, to August 30, 2018.
Interventions


Intervention schools received a program that included breakfast in the classroom and breakfast-specific nutrition education. Control schools continued breakfast before school in the cafeteria and standard nutrition education.
Main Outcomes and Measures


The primary outcome was the combined incidence of overweight and obesity. Secondary outcomes included the combined prevalence of overweight and obesity, incidence and prevalence of obesity, changes in body mass index (BMI) z score, and School Breakfast Program participation.
Results


Among the 1362 students, mean (SD) age was 10.8 (0.96) years and 700 (51.4%) were female; 907 (66.6%) were black, 233 (17.1%) were Hispanic, 100 (7.3%) were white, 83 (6.1%) were Asian, and 39 were of multiple or other race/ethnicity. After 2.5 years, students in intervention schools had participated in the School Breakfast Program 53.8% of days, compared with 24.9% of days among students in control schools (β = 0.33; 95% CI, 0.22-0.42). There was no difference between intervention and control schools in the combined incidence of overweight and obesity after 2.5 years (11.7% vs 9.3%; odds ratio [OR] 1.31; 95% CI, 0.85-2.02; P = .22). However, the incidence (11.6% vs 4.4%; OR, 2.43; 95% CI, 1.47-4.00) and prevalence (28.0% vs 21.2%; OR, 1.46; 95% CI, 1.11-1.92) of obesity were higher in intervention schools than in control schools after 2.5 years.
Conclusions and Relevance


A breakfast in the classroom initiative increased participation in the School Breakfast Program and did not affect the combined incidence of overweight and obesity. However, the initiative had an unintended consequence of increasing incident and prevalent obesity. Further research is needed to identify approaches to increase participation in the School Breakfast Program that do not increase obesity among students.
Trial Registration


ClinicalTrials.gov identifier: NCT01924130.",2019,"There was no difference between intervention and control schools in the combined incidence of overweight and obesity after 2.5 years (11.7% vs 9.3%; odds ratio [OR] 1.31; 95% CI, 0.85-2.02; P = .22).","['1362 students, mean (SD) age was 10.8 (0.96) years and 700 (51.4%) were female; 907 (66.6%) were black, 233 (17.1%) were Hispanic, 100 (7.3%) were white, 83 (6.1%) were Asian, and 39 were of multiple or other race/ethnicity', 'Urban School-aged Children', 'urban children in low-income communities', 'Participants were recruited in September 2013, and the intervention began in January 2014', 'Sixteen kindergarten through eighth grade Philadelphia public schools with universal breakfast participated', '1362 fourth- through sixth-grade students from low-income urban communities across 2.5 years']","['Classroom Initiative', 'program that included breakfast in the classroom and breakfast-specific nutrition education', 'Breakfast']","['overweight and obesity', 'combined prevalence of overweight and obesity, incidence and prevalence of obesity, changes in body mass index (BMI) z score, and School Breakfast Program participation', 'combined incidence of overweight and obesity']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205440', 'cui_str': 'Sixth (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",1362.0,0.0409673,"There was no difference between intervention and control schools in the combined incidence of overweight and obesity after 2.5 years (11.7% vs 9.3%; odds ratio [OR] 1.31; 95% CI, 0.85-2.02; P = .22).","[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Polonsky', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Katherine W', 'Initials': 'KW', 'LastName': 'Bauer', 'Affiliation': 'Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Fisher', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Davey', 'Affiliation': 'College of Health Sciences and Department of Behavioral Health and Nutrition, University of Delaware, Newark.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'The Food Trust, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Abel', 'Affiliation': 'The Food Trust, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hanlon', 'Affiliation': 'Department of Statistics, Virginia Polytechnic Institute and State University, Roanoake.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Ruth', 'Affiliation': 'Fox Chase Cancer Center, Temple Health, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Dale', 'Affiliation': 'The Food Trust, Philadelphia, Pennsylvania.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, Pennsylvania.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2018.5531']
3130,30772850,Using specialist screening practitioners (SSPs) to increase uptake of bowel scope (flexible sigmoidoscopy) screening: results of a feasibility single-stage phase II randomised trial.,"OBJECTIVE


To determine the feasibility of specialist screening practitioners (SSPs) offering patient navigation (PN) to facilitate uptake of bowel scope screening (BSS) among patients who do not confirm or attend their appointment.
DESIGN


A single-stage phase II trial.
SETTING


South Tyneside District Hospital, Tyne and Wear, England, UK.
PARTICIPANTS


Individuals invited for BSS at South Tyneside District Hospital during the 6-month recruitment period were invited to participate in the study.
INTERVENTION


Consenting individuals were randomly assigned to either the PN intervention or usual care group in a 4:1 ratio. The intervention involved BSS non-attenders receiving a phone call from an SSP to elicit their reasons for non-attendance and offer educational, practical and emotional support as required. If requested by the patient, another BSS appointment was then scheduled.
PRIMARY OUTCOME MEASURE


The number of non-attenders in the intervention group who were navigated and then rebooked and attended their new BSS appointment.
SECONDARY OUTCOME MEASURES


Barriers to BSS attendance, patient-reported outcomes including informed choice and satisfaction with BSS and the PN intervention, reasons for study non-participation, SSPs' evaluation of the PN process and a cost analysis.
RESULTS


Of those invited to take part (n=1050), 152 (14.5%) were randomised into the study: PN intervention=109; usual care=43. Most participants attended their BSS appointment (PN: 79.8%; control: 79.1%) leaving 22 eligible for PN: only two were successfully contacted. SSPs were confident in delivering PN, but were concerned that low BSS awareness and information overload may have deterred patients from taking part in the study. Difficulty contacting patients was reported as a burden to their workload.
CONCLUSIONS


PN, as implemented, was not a feasible intervention to increase BSS uptake in South Tyneside. Interventions to increase BSS awareness may be better suited to this population.
TRIAL REGISTRATION NUMBER


ISRCTN13314752; Results.",2019,"The intervention involved BSS non-attenders receiving a phone call from an SSP to elicit their reasons for non-attendance and offer educational, practical and emotional support as required.","['Consenting individuals', 'South Tyneside District Hospital, Tyne and Wear, England, UK', 'Of those invited to take part (n=1050), 152 (14.5', 'patients who do not confirm or attend their appointment', 'Individuals invited for BSS at South Tyneside District Hospital during the 6-month recruitment period were invited to participate in the study']","['specialist screening practitioners (SSPs) offering patient navigation (PN', 'specialist screening practitioners (SSPs', 'PN intervention or usual care group']","[""informed choice and satisfaction with BSS and the PN intervention, reasons for study non-participation, SSPs' evaluation of the PN process and a cost analysis"", 'BSS uptake', 'number of non-attenders']","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0454880', 'cui_str': 'Tyne and Wear (geographic location)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.114306,"The intervention involved BSS non-attenders receiving a phone call from an SSP to elicit their reasons for non-attendance and offer educational, practical and emotional support as required.","[{'ForeName': 'Lesley M', 'Initials': 'LM', 'LastName': 'McGregor', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Skrobanski', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Ritchie', 'Affiliation': 'South of Tyne Bowel Cancer Screening Centre, Gateshead Health NHS Foundation Trust, Queen Elizabeth Hospital, Gateshead, UK.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Berkman', 'Affiliation': 'Patient Representative, London, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Miller', 'Affiliation': 'South of Tyne Bowel Cancer Screening Centre, Gateshead Health NHS Foundation Trust, Queen Elizabeth Hospital, Gateshead, UK.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Freeman', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Nishma', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Health Research, University College London, London, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Rees', 'Affiliation': 'South Tyneside NHS Foundation Trust, South Tyneside District Hospital, Tyne and Wear, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2018-023801']
3131,31821109,NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2.,"PURPOSE


Adjuvant trastuzumab reduces invasive breast cancer (IBC) recurrence and risk for death in patients with HER2-amplified or overexpressing IBC. A subset of patients in the landmark trastuzumab adjuvant trials who originally tested HER2-positive but were HER2-negative by central HER2 testing appeared to possibly benefit from trastuzumab. The objective for the NSABP B-47 trial was to determine whether the addition of trastuzumab to adjuvant chemotherapy (CRx) would improve invasive disease-free survival (IDFS) in patients with HER2-negative breast cancer.
PATIENTS AND METHODS


A total of 3,270 women with high-risk primary IBC were randomly assigned to CRx with or without 1 year of trastuzumab. Eligibility criteria included immunohistochemistry (IHC) score 1+ or 2+ with fluorescence in situ hybridization ratio (FISH) < 2.0 or, if ratio was not performed, HER2 gene copy number < 4.0. CRx was either docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide followed by weekly paclitaxel for 12 weeks.
RESULTS


At a median follow-up of 46 months, the addition of trastuzumab to CRx did not improve IDFS (5-year IDFS: 89.8% with CRx plus trastuzumab [CRxT]  v  89.2% with CRx alone; hazard ratio [HR], 0.98; 95% CI, 0.76 to 1.25;  P  = .85). These findings did not differ by level of HER2 IHC expression, lymph node involvement, or hormone-receptor status. For distant recurrence-free interval, 5-year estimates were 92.7% with CRxT compared with 93.6% for CRx alone (HR, 1.10; 95% CI, 0.81 to 1.50;  P  = .55) and for overall survival (OS) were 94.8% with CRxT and 96.3% in CRx alone (HR, 1.33; 95% CI, 0.90 to 1.95;  P  = .15). There were no unexpected toxicities from the addition of trastuzumab to CRx.
CONCLUSION


The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC. Trastuzumab does not benefit women without IHC 3+ or FISH ratio-amplified breast cancer.",2020,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","['3,270 women with high-risk primary IBC', 'patients with HER2-negative breast cancer', 'patients with HER2-amplified or overexpressing IBC']","['trastuzumab to adjuvant chemotherapy (CRx', 'Adjuvant Chemotherapy', 'CRx with or without 1 year of trastuzumab', 'CRx plus trastuzumab [CRxT', 'Trastuzumab', 'docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide', 'trastuzumab']","['IDFS, distant recurrence-free interval, or OS', 'invasive disease-free survival (IDFS', 'level of HER2 IHC expression, lymph node involvement, or hormone-receptor status', 'toxicities', 'IDFS ', 'distant recurrence-free interval, 5-year estimates', '5-year IDFS', 'overall survival (OS', 'invasive breast cancer (IBC) recurrence and risk for death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0449443', 'cui_str': 'Receptor status (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3270.0,0.231243,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Reena S', 'Initials': 'RS', 'LastName': 'Cecchini', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Costantino', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Crown', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Polikoff', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Boileau', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Stokoe', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Moore', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Virginia F', 'Initials': 'VF', 'LastName': 'Borges', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01455']
3132,31226435,Taurine supplementation increases irisin levels after high intensity physical training in obese women.,"BACKGROUND


Irisin is a myokine/adipokine that under stimulus of physical exercise is able to improve thermogenic capacity in adipose tissue. Likewise, taurine supplementation has demonstrated similar effects on energy metabolism. Therefore, we hypothesized that taurine supplementation combined with physical training may induce an increase in irisin concentrations, optimizing energy metabolism in obese individuals.
OBJECTIVE


To evaluate if taurine supplementation associated with a high intensity physical training program increases irisin levels in obese women.
METHODS


double-blind study with 22 obese women (BMI 32.4 ± 2.0 kg/m 2 , 36.6 ± 6.4 years and sedentary) who were randomly divided into two groups, control group (GC, n = 14), exercised and supplemented with placebo (3 g of starch), and taurine group (GTAU, n = 8), exercised and supplemented with taurine (3 g). The subjects performed high intensity physical training, Deep Water Running (DWR), for 8 weeks, 3 times/week, for 50 min per training session, at 70-85% maximum heart rate. Resting metabolic rate (RMR) was evaluated by indirect calorimetry, body composition by deuterium oxide, plasma taurine by HPLC, plasma irisin by Multiplex Kit, and food consumption by food records. The results were analyzed by an ANOVA two way repeated measures mixed model, with the Sidak post hoc (p < 0.05).
RESULTS


No changes were observed in body composition. DWR increased RMR independent of supplementation (p < 0.001) and irisin levels (pg/mL) showed a significant difference only in the GTAU in 1 h after exercise (p < 0.001).
CONCLUSION


DWR associated with taurine supplementation resulted in increased plasma irisin concentrations after physical training in obese adult women.",2019,"DWR increased RMR independent of supplementation (p < 0.001) and irisin levels (pg/mL) showed a significant difference only in the GTAU in 1 h after exercise (p < 0.001).
","['22 obese women (BMI 32.4\u202f±\u202f2.0\u202fkg/m 2 , 36.6\u202f±\u202f6.4\u202fyears and sedentary', 'obese individuals', 'obese women', 'obese adult women']","['taurine supplementation combined with physical training', 'Taurine supplementation', 'taurine supplementation', 'intensity physical training program', 'intensity physical training, Deep Water Running (DWR', 'control group (GC, n\u202f=\u202f14), exercised and supplemented with placebo (3\u202fg of starch), and taurine group (GTAU, n\u202f=\u202f8), exercised and supplemented with taurine']","['energy metabolism', 'Resting metabolic rate (RMR', 'plasma irisin concentrations', 'irisin levels', 'body composition', 'body composition by deuterium oxide, plasma taurine by HPLC, plasma irisin by Multiplex Kit, and food consumption', 'irisin concentrations, optimizing energy metabolism']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517709', 'cui_str': '32.4 (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0454406', 'cui_str': 'Water running (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0039350', 'cui_str': 'Taurine'}, {'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",22.0,0.111995,"DWR increased RMR independent of supplementation (p < 0.001) and irisin levels (pg/mL) showed a significant difference only in the GTAU in 1 h after exercise (p < 0.001).
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Batitucci', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, Rod. Araraquara - Jau Km 1, Araraquara, SP, Brazil. Electronic address: gabibatitucci@gmail.com.'}, {'ForeName': 'Camila Fernanda Cunha', 'Initials': 'CFC', 'LastName': 'Brandao', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: camilafbrandao@hotmail.com.'}, {'ForeName': 'Flávia Giolo', 'Initials': 'FG', 'LastName': 'De Carvalho', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: flaviagiolo@gmail.com.'}, {'ForeName': 'Julio Sergio', 'Initials': 'JS', 'LastName': 'Marchini', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: jsmarchi@fmrp.usp.br.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Pfrimer', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: karinapfrimer@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Ferrioli', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: eferriol@fmrp.usp.br.'}, {'ForeName': 'Fernando Queiroz', 'Initials': 'FQ', 'LastName': 'Cunha', 'Affiliation': 'Department of Pharmacology, Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: fdqcunha@fmrp.usp.br.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Papoti', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: mpapoti@usp.br.'}, {'ForeName': 'Sara Ivone Barros Morhy', 'Initials': 'SIBM', 'LastName': 'Terrazas', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, Rod. Araraquara - Jau Km 1, Araraquara, SP, Brazil. Electronic address: saraterrazas@yahoo.com.br.'}, {'ForeName': 'Márcia Varella Morandi', 'Initials': 'MVM', 'LastName': 'Junqueira-Franco', 'Affiliation': 'Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: mvmjf@hotmail.com.'}, {'ForeName': 'Adelino Sanchez Ramos', 'Initials': 'ASR', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: adelinosanchez@hotmail.com.'}, {'ForeName': 'Ellen Cristini de', 'Initials': 'EC', 'LastName': 'Freitas', 'Affiliation': 'Department of Food and Nutrition, School of Pharmaceutical Sciences of Araraquara, State University of São Paulo, Rod. Araraquara - Jau Km 1, Araraquara, SP, Brazil; School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, Av. Bandeirantes 3900, Ribeirão Preto, SP, Brazil. Electronic address: ellenfreitas@usp.br.'}]",Cytokine,['10.1016/j.cyto.2019.154741']
3133,31521831,"Dupilumab Efficacy in Patients with Uncontrolled, Moderate-to-Severe Allergic Asthma.","BACKGROUND


Dupilumab blocks the shared receptor component for IL-4 and IL-13, key drivers of type 2 inflammation, including IgE-mediated allergic inflammation in asthma. In the LIBERTY ASTHMA QUEST (NCT02414854) study, dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV 1 ) in patients with uncontrolled, moderate-to-severe asthma with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers (blood eosinophils and fractional exhaled nitric oxide) at baseline.
OBJECTIVE


We assessed dupilumab's effect on key asthma outcomes in QUEST patients with/without evidence of allergic asthma (total serum IgE ≥30 IU/mL and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline).
METHODS


Severe exacerbation rates and change from baseline in FEV 1 , asthma control, and markers of type 2 inflammation during the 52-week treatment period were assessed.
RESULTS


In the allergic asthma subgroup (n = 1083), dupilumab 200/300 mg every 2 weeks versus placebo reduced severe asthma exacerbation rates (-36.9%/-45.5%; both P < .01), improved FEV 1  at week 12 (0.13 L/0.16 L; both P < .001; improvements were evident by the first evaluation at week 2) with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline, and improved asthma control. Dupilumab treatment also resulted in rapid and sustained reductions in type 2 inflammatory biomarkers. Comparable results were observed in patients without evidence of allergic asthma (n = 819).
CONCLUSION


Dupilumab reduced severe exacerbation rates, improved FEV 1  and asthma control, and suppressed type 2 inflammatory biomarkers in patients with uncontrolled, moderate-to-severe asthma with or without evidence of allergic asthma, highlighting the key role of IL-4 and IL-13 in airway inflammation.",2020,"CONCLUSION


Dupilumab reduced severe exacerbation rates, improved FEV 1  and asthma control, and suppressed type 2 inflammatory biomarkers in uncontrolled, moderate-to-severe asthma patients with or without evidence of allergic asthma, highlighting the key role of interleukin-4 and interleukin-13 in airway inflammation.","['QUEST patients with/without evidence of allergic asthma (total serum IgE ≥30 IU/mL and ≥1 perennial aeroallergen-specific IgE ≥0.35 kU/L at baseline', 'patients without evidence of allergic asthma (n=819', 'Patients With Uncontrolled, Moderate-to-Severe Allergic Asthma']",['placebo'],"['forced expiratory volume', 'severe exacerbation rates', 'FEV', 'FEV 1 , asthma control, and markers of type 2 inflammation', 'severe asthma exacerbation rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0001697', 'cui_str': 'Aeroallergen (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]",,0.199957,"CONCLUSION


Dupilumab reduced severe exacerbation rates, improved FEV 1  and asthma control, and suppressed type 2 inflammatory biomarkers in uncontrolled, moderate-to-severe asthma patients with or without evidence of allergic asthma, highlighting the key role of interleukin-4 and interleukin-13 in airway inflammation.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'David Geffen School of Medicine at UCLA, Los Angeles, Calif. Electronic address: jcorren@ucla.edu.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Washington University School of Medicine, St. Louis, Mo.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""O'Riordan"", 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Nicola A', 'Initials': 'NA', 'LastName': 'Hanania', 'Affiliation': 'Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain.'}, {'ForeName': 'Bradley E', 'Initials': 'BE', 'LastName': 'Chipps', 'Affiliation': 'Capital Allergy and Respiratory Disease Center, Sacramento, Calif.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Wenzel', 'Affiliation': 'University of Pittsburgh Asthma Institute, Pittsburgh, Pa.'}, {'ForeName': 'Karthinathan', 'Initials': 'K', 'LastName': 'Thangavelu', 'Affiliation': 'Sanofi, Cambridge, Mass.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Rice', 'Affiliation': 'Sanofi, Cambridge, Mass.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Harel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Jagerschmidt', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Asif H', 'Initials': 'AH', 'LastName': 'Khan', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Siddhesh', 'Initials': 'S', 'LastName': 'Kamat', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Jaman', 'Initials': 'J', 'LastName': 'Maroni', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rowe', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Amin', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Ruddy', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Teper', 'Affiliation': 'Sanofi, Bridgewater, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.08.050']
3134,31478704,"Reinforcer pathology: Narrative of hurricane-associated loss increases delay discounting, demand, and consumption of highly palatable snacks in the obese.","Reinforcer pathology is derived from the integration of two measures: (a) self-control (i.e., delay discounting), and (b) reward valuation (i.e., behavioral economic demand). Narrative theory asserts that vividly imagining oneself in a hypothetical, yet realistic, scenario can acutely alter decision making, valuation of reinforcers such as food, and how much food is consumed. The present study measured changes in reinforcer pathology for highly palatable snacks following either a negative or neutral scenario in obese individuals. Participants (N = 48), with a body mass index of 30 or greater, rated their liking of 7 calorie-dense snack items and completed discounting and purchase demand tasks for their top-rated snack. Participants then read a randomly assigned hypothetical scenario (i.e., a devastating hurricane [negative] or minor storm [neutral]), completed the tasks again, and were given ad libitum access to their top 3 ranked snack foods. Results indicated that delay discounting, demand for participants' top-rated snack food, and negative affect all increased in the hurricane group compared with the minor storm group. The hurricane group also consumed more calories, even when hunger was standardized with a preload meal bar. Consistent with reinforcer pathology, these results suggest that vivid consideration of a devastating scenario constricts the temporal window and increases demand for hedonic snack foods among obese individuals. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Participants (N = 48), with a body mass index of 30 or greater, rated their liking of 7 calorie-dense snack items and completed discounting and purchase demand tasks for their top-rated snack.","['obese individuals', 'Reinforcer pathology', 'Participants (N = 48), with a body mass index of 30 or greater, rated their liking of 7 calorie-dense snack items and completed discounting and purchase demand tasks for their top-rated snack']",['devastating hurricane [negative] or minor storm [neutral'],"['delay discounting, demand, and consumption of highly palatable snacks', ""delay discounting, demand for participants' top-rated snack food, and negative affect"", 'hedonic snack foods']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0020183', 'cui_str': 'Hurricanes'}, {'cui': 'C0026193', 'cui_str': 'Minors'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3494314', 'cui_str': 'Snacking'}, {'cui': 'C0453863', 'cui_str': 'Snack Food'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",2019.0,0.0892588,"Participants (N = 48), with a body mass index of 30 or greater, rated their liking of 7 calorie-dense snack items and completed discounting and purchase demand tasks for their top-rated snack.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Snider', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Mellis', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Poe', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Kocher', 'Affiliation': 'Graduate Program in Translational Biology, Medicine, and Health.'}, {'ForeName': 'Jamie K', 'Initials': 'JK', 'LastName': 'Turner', 'Affiliation': 'Addiction Recovery Research Center.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000498']
3135,30232744,"Effects of Probiotic Yogurt on Serum Omentin-1, Adropin, and Nesfatin-1 Concentrations in Overweight and Obese Participants Under Low-Calorie Diet.","Data on the effects of probiotics on adipokines such as omentin-1, nesfatin-1, and adropin are limited. The aim of this study was to evaluate the effects of probiotic yogurt along with a low-calorie diet (LCD) on serum omentin-1, adropin, and nesfatin-1 concentrations in obese and overweight individuals. Sixty obese or overweight individuals aged 20-50 years old were involved in this randomized double-blind placebo-controlled clinical trial. Participants were randomly allocated into two groups to consume either probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001 (10 8  CFU/g each) (n = 30) or regular yogurt (n = 30) along with a LCD in both groups for 8 weeks. Fasting blood samples were taken at baseline and after the 8-week intervention to determine related variables. A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002). After the 8-week intervention, a significant difference in serum adropin concentration (6.04 ± 24.46 vs - 8.16 ± 24.66 pg/ml, P = 0.03 and serum omentin-1 concentration (0.09 ± 1.51 vs - 1.5 ± 1.8 ng/ml, P = 0.003) was observed between two groups. We did not observe any significant changes in nesfatin-1 and other anthropometric measures. Overall, probiotic yogurt for 8 weeks among overweight or obese individuals along with LCD had beneficial effects on body fat percentage, serum omentin-1, and adropin concentration, but it did not have any effect on nesfatin-1 level.",2019,"A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002).","['Sixty obese or overweight individuals aged 20-50\xa0years old', 'obese and overweight individuals', 'Overweight and Obese Participants Under Low-Calorie Diet']","['Probiotic Yogurt', 'probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001', 'low-calorie diet (LCD', 'placebo']","['body fat percentage, serum omentin-1, and adropin concentration', 'serum adropin concentration', 'serum omentin-1, adropin, and nesfatin-1 concentrations', 'Fasting blood samples', 'serum omentin-1 concentration', 'Serum Omentin-1, Adropin, and Nesfatin-1 Concentrations', 'body fat percentage']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}]","[{'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0535447,"A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002).","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Raji Lahiji', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Salehi', 'Affiliation': 'Immunology Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Yazdani', 'Affiliation': 'Department of Microbiology, School of Biology Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Raheleh', 'Initials': 'R', 'LastName': 'Shokouhi Shoormasti', 'Affiliation': 'Immunology, Asthma and Allergy Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. farzadshidfar@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9470-3']
3136,31394276,Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT).,"Herpes zoster (HZ) can have a substantial impact on quality of life (QoL). The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). Herein, we report the impact of RZV on patients' QoL. Autologous HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1 to 2 months apart. QoL was measured by the Short Form Survey-36 and Euro-QoL-5 Dimension at baseline, 1 month, and 1 year postdose 2 and during suspected HZ episodes with the Zoster Brief Pain Inventory (ZBPI). The RZV impact on ZBPI burden of illness and burden of interference scores was estimated. The 2 scores were calculated from the area under the curve (days 0 to 182) of the ZBPI worst pain and ZBPI activities of daily living scores, respectively, assuming a score of 0 for patients not having a confirmed HZ episode. The ZBPI maximum worst pain score was significantly lower in the RZV than placebo group (mean: 5.8 versus 7.1, P = .011). Consequently, the VE estimates for HZ burden of illness (82.5%; 95% CI, 73.6 to 91.4) and burden of interference (82.8%; 95% CI, 73.3 to 92.3) were higher than the HZ VE estimate (ie, 68.2%). RZV showed significantly better QoL scores than placebo 1 week following rash onset among patients with confirmed HZ. In addition to reducing the risk of HZ and its complications, RZV significantly reduced the impact of HZ on patients' QoL in those who developed breakthrough disease.",2019,"The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414).","['Adult Autologous Hematopoietic Stem Cell Transplant Recipients', ""patients' QoL. Autologous HSCT recipients""]","['Herpes zoster (HZ', 'RZV', 'recombinant zoster vaccine (RZV', 'placebo', 'RZV or placebo', 'HZ', 'Recombinant Zoster Vaccine', 'Placebo']","['QoL', 'quality of life (QoL', 'HZ burden of illness', 'risk of HZ', 'QoL scores', 'ZBPI maximum worst pain score', 'ZBPI worst pain and ZBPI activities of daily living scores', 'burden of interference', 'ZBPI burden of illness and burden of interference scores', 'Quality of Life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034380'}, {'cui': 'C0162698', 'cui_str': 'Economic Burden of Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001288', 'cui_str': 'ADL'}]",,0.549255,"The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414).","[{'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: desmond.x.curran@gsk.com.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Matthews', 'Affiliation': 'Freelance c/o GSK, Wavre, Belgium.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rowley', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Jo-Anne H', 'Initials': 'JH', 'LastName': 'Young', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Bastidas', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Haematology Department, G. Papanikolaou General Hospital of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Barista', 'Affiliation': 'Hacettepe University Medical Faculty, Ankara, Turkey.'}, {'ForeName': 'Pranatharthi Haran', 'Initials': 'PH', 'LastName': 'Chandrasekar', 'Affiliation': 'Karmanos Cancer Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': 'Clinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Idrissi', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Heras', 'Affiliation': 'Hospital General Universitario J. M. Morales Meseguer, Murcia, Spain.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Milliken', 'Affiliation': ""Department of Haematology, St Vincent's Hospital, Darlinghurst, New South Wales, Australia.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Monserrat Coll', 'Affiliation': 'Hospital Virgen de la Arrixaca, Murcia (El Palmar), Spain.'}, {'ForeName': 'María Belén', 'Initials': 'MB', 'LastName': 'Navarro Matilla', 'Affiliation': 'Hospital Puerta de Hierro, Majadahonda (Madrid), Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Oostvogels', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Piątkowska-Jakubas', 'Affiliation': 'Department of Haematology, Jagiellonian University Medical College, Cracow, Poland.'}, {'ForeName': 'Dimas', 'Initials': 'D', 'LastName': 'Quiel', 'Affiliation': 'Complejo Hospitalario Dr. Arnulfo Arias Madrid, Panama, Panama.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Sabry', 'Affiliation': 'Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwartz', 'Affiliation': 'Department of Hematology and Oncology, Charité University Medical Center, Berlin, Germany.'}, {'ForeName': 'Dominik L D', 'Initials': 'DLD', 'LastName': 'Selleslag', 'Affiliation': 'Hematologie, AZ Sint-Jan Brugge-Oostende AV-Campus Sint-Jan, Brugge, Belgium.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Sullivan', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Theunissen', 'Affiliation': 'Jessa Ziekenhuis-Campus Virga Jesse, Hasselt, Belgium.'}, {'ForeName': 'Zeynep Arzu', 'Initials': 'ZA', 'LastName': 'Yegin', 'Affiliation': 'Gazi University Medical Faculty, Ankara, Turkey.'}, {'ForeName': 'Su-Peng', 'Initials': 'SP', 'LastName': 'Yeh', 'Affiliation': 'Department of Hematology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Zaja', 'Affiliation': 'Clinica Ematologica, Azienda Ospedaliero Universitaria S. Maria Misericordia, Friuli-Venezia-Giulia, Udine, Italy.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': 'Royal Melbourne Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.07.036']
3137,31495592,Phase 1 trial of a 20-valent pneumococcal conjugate vaccine in healthy adults.,"INTRODUCTION


Streptococcus pneumoniae is a leading cause of bacteremia, bacterial pneumonia, and meningitis, and is associated with substantial morbidity and mortality, particularly in those under 2 years of age and those over 65 years of age. While significant progress against S. pneumoniae-related disease has been made as a result of the introduction of pneumococcal conjugate vaccines (PCV7, PCV10 and PCV13), there remains value in further expanding pneumococcal vaccine serotype coverage. Here we present the first report of a 20-valent pneumococcal conjugate vaccine (PCV20) containing capsular polysaccharide conjugates present in PCV13 as well as 7 new serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) which are important contributors to pneumococcal disease.
METHODS


This Phase I first-in-human study was a randomized, controlled, observer-blinded study with a two-arm parallel design to assess the safety, tolerability, and immunogenicity of PCV20 in adults. A total of 66 healthy adults 18-49 years of age with no history of pneumococcal vaccination were enrolled and randomized to receive a single dose of PCV20 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) control. Local injection site reactions, select systemic symptoms, laboratory studies, and adverse events were assessed. Opsonophagocytic activity (OPA) titers and IgG concentrations were measured in sera collected prior to, and approximately one month (28-35 days) after vaccination.
RESULTS


Vaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes. The overall safety profile of PCV20 was similar to Tdap, and generally consistent with that observed after PCV13 administration.
CONCLUSIONS


Vaccination with PCV20 was well tolerated and induced substantial functional (OPA) and IgG responses to all vaccine serotypes. There were no safety issues identified in this Phase 1 study, and the data supported further evaluation of PCV20.",2019,"RESULTS


Vaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes.","['adults', 'healthy adults', 'those under 2\u202fyears of age and those over 65\u202fyears of age', '66 healthy adults 18-49\u202fyears of age with no history of pneumococcal vaccination']","['PCV20', 'PCV20 or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) control', '20-valent pneumococcal conjugate vaccine', '20-valent pneumococcal conjugate vaccine (PCV20']","['tolerated and induced substantial functional (OPA) and IgG responses', 'overall safety profile of PCV20', 'IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs', 'Opsonophagocytic activity (OPA) titers and IgG concentrations', 'safety, tolerability, and immunogenicity of PCV20']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}]","[{'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0206253', 'cui_str': 'Vaccines, Combination'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",66.0,0.216656,"RESULTS


Vaccination with PCV20 elicited substantial IgG and functional bactericidal immune responses as demonstrated by increases in IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) to the 20 vaccine serotypes.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lamberth', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States. Electronic address: Erik.Lamberth@Pfizer.com.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Severs', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Scully', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Sanela', 'Initials': 'S', 'LastName': 'Tarabar', 'Affiliation': 'Pfizer Clinical Research Unit, Pfizer, Inc., New Haven, CT, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ginis', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States.'}, {'ForeName': 'Kathrin U', 'Initials': 'KU', 'LastName': 'Jansen', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Gruber', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Pearl River, NY, United States.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Scott', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Watson', 'Affiliation': 'Vaccine Research and Development, Pfizer, Inc., Collegeville, PA, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.08.048']
3138,31144028,Does training mental rotation transfer to gains in mathematical competence? Assessment of an at-home visuospatial intervention.,"The current study examined whether the effect of spatial training transfers to the math domain. Sixty-two 6- and 7-year-olds completed an at-home 1-week online training intervention. The spatial-training group received mental rotation training, whereas the active control group received literacy training in a format that matched the spatial training. Results revealed near transfer of mental rotation ability in the spatial-training group. More importantly, there was also far transfer to canonical arithmetic problems, such that children in the spatial-training group performed better on these math problems than children in the control group. Such far transfer could not be attributed to general cognitive improvement, since no improvement was observed for non-symbolic quantity processing, verbal working memory (WM), or language ability following spatial training. Spatial training may have benefitted symbolic arithmetic performance by improving visualization ability, access to the mental number line, and/or increasing the capacity of visuospatial WM.",2020,"Such far transfer could not be attributed to general cognitive improvement, since no improvement was observed for non-symbolic quantity processing, verbal working memory (WM), or language ability following spatial training.",[],"['6-\xa0and\xa07-year-olds completed an at-home 1-week online training intervention', 'spatial training transfers', 'mental rotation training, whereas the active control group received literacy training in a format that matched the spatial training', 'Spatial training']","['non-symbolic quantity processing, verbal working memory (WM), or language ability', 'near transfer of mental rotation ability']",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",,0.0153904,"Such far transfer could not be attributed to general cognitive improvement, since no improvement was observed for non-symbolic quantity processing, verbal working memory (WM), or language ability following spatial training.","[{'ForeName': 'Chi-Ngai', 'Initials': 'CN', 'LastName': 'Cheung', 'Affiliation': 'Department of Psychology, Emory University, 36 Eagle Row, Atlanta, GA, 30322, USA. chingai.cheung@gmail.com.'}, {'ForeName': 'Jenna Y', 'Initials': 'JY', 'LastName': 'Sung', 'Affiliation': 'Department of Psychology, Emory University, 36 Eagle Row, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Stella F', 'Initials': 'SF', 'LastName': 'Lourenco', 'Affiliation': 'Department of Psychology, Emory University, 36 Eagle Row, Atlanta, GA, 30322, USA. stella.lourenco@emory.edu.'}]",Psychological research,['10.1007/s00426-019-01202-5']
3139,31626990,Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma.,"BACKGROUND


Reslizumab displays efficacy in patients with inadequately controlled eosinophilic asthma; previous reports in oral corticosteroid-dependent asthma are limited.
OBJECTIVE


To assess efficacy of reslizumab in oral corticosteroid-dependent patients and benefits on oral corticosteroid burden.
METHODS


We report post hoc analyses of pooled data from duplicate, placebo-controlled phase 3 trials. Patients aged 12 to 75 years with inadequately controlled, moderate-to-severe asthma were randomized 1:1 to receive intravenous reslizumab 3.0 mg/kg or placebo every 4 weeks for 52 weeks, stratified by oral corticosteroid use at enrollment and by region. Assessments included efficacy and predictors of clinical asthma exacerbation response in oral corticosteroid-dependent patients, and systemic corticosteroids burden in the overall population.
RESULTS


Patients were randomized to reslizumab (n = 477) or placebo (n = 476); 73 (15%) patients in each group were taking oral corticosteroids at baseline. Reslizumab was favored over placebo for all efficacy end points in oral corticosteroid-dependent patients, with numerically greater improvements in oral corticosteroid-dependent patients than the overall population. Having 2 or more versus 1 clinical asthma exacerbation in the previous 12 months was the strongest positive predictor of reduced exacerbation risk with reslizumab (risk reduction, 77.5% vs 15.2%; P ≤ .02). Significantly fewer new systemic corticosteroid prescriptions were issued per patient receiving reslizumab versus placebo (mean ± SD, 0.5 ± 1.07 vs 1.0 ± 1.52; P < .0001). Total and per-patient systemic corticosteroid burdens were lower: 121,135 versus 290,977 mg and 254 versus 611 mg/patient, respectively (both P < .0001).
CONCLUSIONS


Oral corticosteroid-dependent patients benefited from reslizumab across asthma efficacy outcome measures. Reslizumab-treated patients required fewer new systemic corticosteroid prescriptions and had a lower systemic corticosteroid burden compared with placebo.",2020,Reslizumab-treated patients required fewer new SCS prescriptions and had a lower systemic corticosteroid burden compared with placebo.,"['patients with inadequately controlled eosinophilic asthma', 'Patients aged 12-75 with inadequately controlled, moderate-to-severe asthma', 'oral corticosteroid-dependent asthma']","['Reslizumab', 'reslizumab', 'placebo', 'intravenous reslizumab 3.0 mg/kg or placebo', 'intravenous reslizumab']","['new SCS prescriptions', 'new systemic corticosteroid prescriptions', 'Total and per-patient systemic corticosteroid burdens', 'efficacy and predictors of clinical asthma exacerbation response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]",,0.68511,Reslizumab-treated patients required fewer new SCS prescriptions and had a lower systemic corticosteroid burden compared with placebo.,"[{'ForeName': 'Parameswaran', 'Initials': 'P', 'LastName': 'Nair', 'Affiliation': ""Department of Medicine, McMaster University & St Joseph's Healthcare Hamilton, Hamilton, ON, Canada. Electronic address: parames@mcmaster.ca.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bardin', 'Affiliation': 'Monash Lung and Sleep, Monash Medical Centre and University, Melbourne, VIC, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Université Paris-Sud, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Murphy', 'Affiliation': 'Boys Town National Research Hospital, Boys Town, Neb.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hickey', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc, Malvern, Pa.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Garin', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc, Malvern, Pa.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Vanlandingham', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc, Malvern, Pa.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chanez', 'Affiliation': 'Department of Respiratory Diseases, Aix-Marseille University, Marseille, France.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.09.036']
3140,31598912,Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI Study.,"BACKGROUND


Metabolic acidosis is associated with accelerated progression of chronic kidney disease (CKD). Whether treatment of metabolic acidosis with sodium bicarbonate improves kidney and patient survival in CKD is unclear.
METHODS


We conducted a randomized (ratio 1:1). open-label, controlled trial (NCT number: NCT01640119. www.clinicaltrials.gov ) to determine the effect in patients with CKD stage 3-5 of treatment of metabolic acidosis with sodium bicarbonate (SB) on creatinine doubling (primary endpoint), all-cause mortality and time to renal replacement therapy compared to standard care (SC) over 36-months. Parametric, non-parametric tests and survival analyses were used to assess the effect of SB on these outcomes.
RESULTS


A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol/l were enrolled in SB and SC, respectively. Mean (SD) follow-up was 29.6 (9.8) vs 30.3 (10.7) months in SC and SB. respectively. The mean (SD) daily doses of SB was 1.13 (0.10). 1.12 (0.11). and 1.09 (0.12) mmol/kg*bw/day in the first, second and third year of follow-up, respectively. A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001). Similarly, 71 participants [45 (12.3%) in SC and 26 (6.9%) in SB, p = 0.016] started dialysis while 37 participants [25 (6.8%) in SC and 12 (3.1%) in SB, p = 0.004] died. There were no significant effect of SB on blood pressure, total body weight or hospitalizations.
CONCLUSION


In persons with CKD 3-5 without advanced stages of chronic heart failure, treatment of metabolic acidosis with sodium bicarbonate is safe and improves kidney and patient survival.",2019,"A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001).","['chronic kidney disease', 'A total of 376 and 364 individuals with mean (SD) age 67.8 (14.9) years, creatinine clearance 30 (12) ml/min, and serum bicarbonate 21.5 (2.4) mmol', 'patients with CKD stage 3-5 of treatment of metabolic acidosis with']","['SB', 'sodium bicarbonate (SB', 'sodium bicarbonate', 'renal replacement therapy compared to standard care (SC']","['blood pressure, total body weight or hospitalizations', 'mean (SD) daily doses of SB', 'kidney and patient survival']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",71.0,0.0598872,"A total of 87 participants reached the primary endpoint [62 (17.0%) in SC vs 25 (6.6%) in SB, p < 0.001).","[{'ForeName': 'Biagio R', 'Initials': 'BR', 'LastName': 'Di Iorio', 'Affiliation': 'Nephrology and Dialysis Unit, PO ""A. Landolfi"", Solofra, Avellino, Italy. br.diiorio@gmail.com.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Department of Research, Innovation, Brand Reputation, Bergamo Hospital, ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Internal Medicine, University of Utah Health, Salt Lake City, UT, USA.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Dialysis and Nephrology Unit, University of Messina, Messina, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Aucella', 'Affiliation': 'Department of Nephrology and Dialysis, IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Garofano', 'Affiliation': 'Biogem, Section of Genetic and Translational Medicine, Ariano Irpino, Avellino, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ceccarelli', 'Affiliation': 'Biogem, Section of Genetic and Translational Medicine, Ariano Irpino, Avellino, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Di Lullo', 'Affiliation': 'Department of Nephrology and Dialysis, ""L. Parodi-Delfino"" Hospital, Colleferro, Roma, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Capolongo', 'Affiliation': 'Department of Translational Medical Sciences, University of Campania ""Luigi Vanvitelli"", Naples, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Di Iorio', 'Affiliation': 'Data Scientist, Landolfi Nephrology Dialysis Consultant, Solofra, Avellino, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Guastaferro', 'Affiliation': 'Department of Nephrology, ""G. Criscuoli"" Hospital, Sant\'Angelo dei Lombardi, Avellino, Italia.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'Capasso', 'Affiliation': 'Department of Nephrology and Dialysis, IRCCS ""Casa Sollievo della Sofferenza"", San Giovanni Rotondo, Foggia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of nephrology,['10.1007/s40620-019-00656-5']
3141,30535534,"The Effects of Probiotic Supplementation on Genetic and Metabolic Profiles in Patients with Gestational Diabetes Mellitus: a Randomized, Double-Blind, Placebo-Controlled Trial.","This study was carried out to evaluate the effects of probiotic supplementation on genetic and metabolic profiles in patients with gestational diabetes mellitus (GDM) who were not on oral hypoglycemic agents. This randomized, double-blind, placebo-controlled clinical trial was conducted in 48 patients with GDM. Participants were randomly divided into two groups to intake either probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Lactobacillus fermentum (2 × 10 9  CFU/g each) (n = 24) or placebo (n = 24) for 6 weeks. Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM. In addition, probiotic supplementation significantly decreased fasting plasma glucose (β, - 3.43 mg/dL; 95% CI, - 6.48, - 0.38; P = 0.02), serum insulin levels (β, - 2.29 μIU/mL; 95% CI, - 3.60, - 0.99; P = 0.001), and insulin resistance (β, - 0.67; 95% CI, - 1.05, - 0.29; P = 0.001) and significantly increased insulin sensitivity (β, 0.009; 95% CI, 0.004, 0.01; P = 0.001) compared with the placebo. Additionally, consuming probiotic significantly decreased triglycerides (P = 0.02), VLDL-cholesterol (P = 0.02), and total-/HDL-cholesterol ratio (P = 0.006) and significantly increased HDL-cholesterol levels (P = 0.03) compared with the placebo. Finally, probiotic administration led to a significant reduction in plasma malondialdehyde (P < 0.001), and a significant elevation in plasma nitric oxide (P = 0.01) and total antioxidant capacity (P = 0.01) was observed compared with the placebo. Overall, probiotic supplementation for 6 weeks to patients with GDM had beneficial effects on gene expression related to insulin and inflammation, glycemic control, few lipid profiles, inflammatory markers, and oxidative stress.",2019,"Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM.","['48 patients with GDM', 'Patients with Gestational Diabetes Mellitus', 'patients with gestational diabetes mellitus (GDM) who were not on oral hypoglycemic agents']","['placebo', 'Placebo', 'probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Lactobacillus fermentum', 'probiotic supplementation', 'Probiotic Supplementation']","['triglycerides', 'plasma nitric oxide', 'insulin sensitivity', 'VLDL-cholesterol', 'serum insulin levels', 'transforming growth factor beta', 'vascular endothelial growth factor', 'downregulated gene expression of tumor necrosis factor alpha', 'Genetic and Metabolic Profiles', 'insulin resistance', 'peripheral blood mononuclear cells', 'genetic and metabolic profiles', 'total-/HDL-cholesterol ratio', 'insulin and inflammation, glycemic control, few lipid profiles, inflammatory markers, and oxidative stress', 'total antioxidant capacity', 'HDL-cholesterol levels', 'plasma malondialdehyde', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0317603', 'cui_str': 'Lactobacillus fermentum'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0040690', 'cui_str': 'Bone-Derived Transforming Growth Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",48.0,0.444059,"Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM.","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Babadi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khorshidi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran. khorshidi_a@kaums.ac.ir.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavood', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Kavossian', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mafi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Satari', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9490-z']
3142,31942818,Intensive Unimanual Training Leads to Better Reaching and Head Control than Bimanual Training in Children with Unilateral Cerebral Palsy.,"AIMS


To quantify the changes in joint movement control and motor planning of the more-affected upper extremity (UE) during a reach-grasp-eat task in children with Unilateral Spastic Cerebral Palsy (USCP) after either constraint-induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT).
METHODS


Twenty children with USCP (average age 7.7; MACS levels I-II) were randomized into either a CIMT or HABIT group. Both groups received intensive training 6 h a day for 15 days. Children performed a reach-grasp-eat task before and after training with their more-affected hand using 3D kinematic analysis.
RESULTS


Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05). Additionally, both intensive training approaches improved joint control with decreased trunk involvement, greater elbow, and wrist excursions during the reaching phase, and greater elbow excursion during the eating phase ( p  < 0.05). However, only the CIMT group decreased hand curvature during reaching, lowered hand position at grasp, and decreased head rotation during the eating phase ( p  < 0.05).
CONCLUSIONS


The current findings showed that both CIMT and HABIT improved UE joint control, but there were greater effects of CIMT on the more-affected UE motor planning and head control for children with USCP.",2020,"Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05).","['children with Unilateral Spastic Cerebral Palsy (USCP) after either', 'Children with Unilateral Cerebral Palsy', 'children with USCP', 'Twenty children with USCP (average age 7.7; MACS levels I-II']","['Intensive Unimanual Training Leads to Better Reaching and Head Control than Bimanual Training', 'intensive training', 'constraint-induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT', 'CIMT or HABIT', 'CIMT']","['joint control with decreased trunk involvement, greater elbow, and wrist excursions', 'CIMT and HABIT improved UE joint control', 'elbow excursion', 'shorter movement time during reaching, grasping, and eating phases', 'hand curvature during reaching, lowered hand position at grasp, and decreased head rotation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0441925', 'cui_str': 'Level I (tumor staging)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy (regime/therapy)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",20.0,0.0133344,"Both groups illustrated shorter movement time during reaching, grasping, and eating phases after training ( p  < 0.05).","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, Flushing, NY, USA.'}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Spingarn', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, Flushing, NY, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Friel', 'Affiliation': 'Neuroscience, Burke Medical Research Institute, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}]",Physical & occupational therapy in pediatrics,['10.1080/01942638.2020.1712513']
3143,31748296,Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).,"INTRODUCTION


Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life.
METHODS AND ANALYSIS


We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery.
ETHICS AND DISSEMINATION


This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN10386621.",2019,"Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures.","['adult patients with oesophageal cancer', 'patients with oesophageal cancer-the Randomised', 'patients with oesophageal cancer']","['laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO', 'Laparoscopically assisted versus open oesophagectomy', 'Oesophagectomy: Minimally Invasive or Open (ROMIO', 'Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy', 'LAO with OO']","['patient-reported physical function', 'postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0534702', 'cui_str': 'lanthanum oxide'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.281004,"Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures.","[{'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Brierley', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK r.brierley@bristol.ac.uk.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': 'Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Blencowe', 'Affiliation': 'Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Jepson', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Berrisford', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Kerry N L', 'Initials': 'KNL', 'LastName': 'Avery', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Caoimhe T', 'Initials': 'CT', 'LastName': 'Rice', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Moure-Fernandez', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Wong', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Skilton', 'Affiliation': 'Medical Illustration, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Boddy', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Byrne', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Underwood', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Vohra', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Catton', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Kish', 'Initials': 'K', 'LastName': 'Pursnani', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Melhado', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Alkhaffaf', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Krysztopik', 'Affiliation': 'Gastroenterology Department, Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lamb', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Culliford', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Howes', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Chalmers', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Cousins', 'Affiliation': 'Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Elliott', 'Affiliation': 'Gastro-Oesophageal Support and Help Group, Bristol, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'School of Social and Community Medicine, University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Heys', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Wickens', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, University of Bristol, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wilkerson', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hollowood', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Streets', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Titcomb', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Martyn Lee', 'Initials': 'ML', 'LastName': 'Humphreys', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wheatley', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Sanders', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Ariyarathenam', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Noble', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Couper', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard J E', 'Initials': 'RJE', 'LastName': 'Skipworth', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Deans', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sukhbir', 'Initials': 'S', 'LastName': 'Ubhi', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bowrey', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Exon', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Daya Shetty', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Chaparala', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Khurshid', 'Initials': 'K', 'LastName': 'Akhtar', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Farooq', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Simon L', 'Initials': 'SL', 'LastName': 'Parsons', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Neil T', 'Initials': 'NT', 'LastName': 'Welch', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Houlihan', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Upper GI Surgery, Derriford Hospital, Plymouth, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schranz', 'Affiliation': 'Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Rea', 'Affiliation': 'General Surgery Department, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'Department of Surgery, Leicester Royal Infirmary, Leicester, Leicester, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Upper GI Surgery, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hindmarsh', 'Affiliation': 'Department of Oesophago-Gastric Surgery, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Maitland', 'Affiliation': 'Department of General Surgery, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Howie', 'Affiliation': 'Gastroenterology Department, Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Christopher Paul', 'Initials': 'CP', 'LastName': 'Barham', 'Affiliation': 'Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",BMJ open,['10.1136/bmjopen-2019-030907']
3144,30601336,"Tenofovir and telbivudine combination therapy rapidly decreases viral loads in immune-tolerant chronic hepatitis B patients awaiting assisted reproduction: an open-label, randomized, controlled study.","BACKGROUND


Immune-tolerant chronic hepatitis B (CHB) patients awaiting assisted reproduction (AR) are required to initiate antiviral therapy because of laboratory safety concerns. The antiviral therapy in this group has not been well assessed. We sought to explore the efficacy and safety of the combination therapy (COM) of tenofovir (TDF) and telbivudine (LdT).
PATIENTS AND METHODS


In this open-label, randomized, controlled study, we enrolled and randomized hepatitis B virus e-antigen (HBeAg)-positive CHB patients awaiting AR into the study COM group and the control (TDF) group. The COM group received combination therapy of TDF and LdT, and the TDF group received a single treatment of TDF. The patients were followed up for at least 48 weeks. The primary endpoint was the proportion of patients with undetectable HBV DNA level at week 12.
RESULTS


A total of 121 patients were recruited into the COM group (n=60) and the TDF group (n=61). The percentages of patients with undetectable HBV DNA levels were 90.0% (54/60) in the COM group and 67.2% (41/61) (P=0.002) in the TDF group at week 12; the percentages were 96.6% (58/60) in the COM group and 85.2% (52/61) in the TDF group at week 48 (P=0.028), respectively. HBeAg seroconversion occurred in 5/60 (8.3%) patients in the COM group and 2/61 (3.3%) patients in the TDF group at week 48 (P=0.233).
CONCLUSION


TDF and LdT combination therapy shows a rapid antivirological response in immune-tolerant CHB patients awaiting AR, which provide an alternative for this group at AR centers. However, the HBeAg seroconversion rate is unsatisfactory in the short term.",2019,"The percentages of patients with undetectable HBV DNA levels were 90.0% (54/60) in the COM group and 67.2% (41/61) (P=0.002) in the TDF group at week 12; the percentages were 96.6% (58/60) in the COM group and 85.2% (52/61) in the TDF group at week 48 (P=0.028), respectively.","['A total of 121 patients were recruited into the COM group (n=60) and the TDF group (n=61', 'immune-tolerant chronic hepatitis B patients awaiting assisted reproduction', 'Immune-tolerant chronic hepatitis B (CHB) patients awaiting assisted reproduction (AR', 'enrolled and randomized hepatitis B virus e-antigen (HBeAg)-positive CHB patients awaiting AR into the study COM group and the control (TDF) group']","['COM', 'TDF and LdT combination therapy', 'combination therapy (COM) of tenofovir (TDF) and telbivudine (LdT', 'TDF', 'Tenofovir and telbivudine combination therapy']","['viral loads', 'HBeAg seroconversion', 'HBeAg seroconversion rate', 'undetectable HBV DNA levels', 'efficacy and safety', 'proportion of patients with undetectable HBV DNA level']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0312906', 'cui_str': ""Blood group antigen rh''""}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1453933', 'cui_str': 'telbivudine'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",121.0,0.0763147,"The percentages of patients with undetectable HBV DNA levels were 90.0% (54/60) in the COM group and 67.2% (41/61) (P=0.002) in the TDF group at week 12; the percentages were 96.6% (58/60) in the COM group and 85.2% (52/61) in the TDF group at week 48 (P=0.028), respectively.","[{'ForeName': 'Zhi-Xian', 'Initials': 'ZX', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Feng-Sui', 'Initials': 'FS', 'LastName': 'Chen', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Zhou', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shi-An', 'Initials': 'SA', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Hai-Cong', 'Initials': 'HC', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Li-Rong', 'Initials': 'LR', 'LastName': 'Cai', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Zhi-Yu', 'Initials': 'ZY', 'LastName': 'Zeng', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}, {'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Disease, Fuzhou General Hospital (Dongfang Hospital), Xiamen University.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001345']
3145,30720379,Effect of prenatal counseling on exclusive breastfeeding frequency and infant weight gain in mothers with previous unsuccessful breastfeeding: a randomized controlled clinical trial.,"Introduction:  Breastfeeding counseling and mother support provision positively affect the duration of exclusive breastfeeding and infant growth and development. This study aimed to determine the effect of prenatal counseling on the frequency of exclusive breastfeeding and infant weight gain in mothers with previous unsuccessful breastfeeding. Methods:  This was a randomized clinical trial on 108 pregnant women who visited the healthcare centers in Tabriz-Iran from November 2017 to May 2018. Participants were randomly allocated either to an intervention or a control group. The intervention group received four breastfeeding counseling sessions in the third trimester, whereas the control group merely received routine care. Counseling was offered to mothers until day 15, 2 months and the end of the month 4 postpartum, in case of experiencing any problem. A researcher-made breastfeeding performance checklist was completed by the groups on three occasions ( p  < .05 considered as the significance level). Findings:  The frequency of exclusive breastfeeding in the intervention group was 75.9, 72.2, and 72.2% on day 15, and 2 and 4 months postpartum, respectively. It was 31.5, 16.7, and 16.7% in the control group, respectively. The probability of exclusive breastfeeding on day 15, month 2, and month 4 was significantly higher in the intervention group. The mean infant weight on day 15 postpartum was significant in the intervention group (mean difference = 112.2; 95% confidence interval = 29.8-194.5;  p  = .008). No statistically significant difference was observed between the groups in terms of infant weight gain in months 2 ( p  = .221) and 4 ( p  = .128) postpartum. Result:  The results of the study showed that pregnancy counseling increases the frequency of exclusive breastfeeding in mothers.",2020,"No statistically significant difference was observed between the groups in terms of infant weight gain in months 2 (p = .221) and 4 (p = .128) postpartum.
","['108 pregnant women who visited the healthcare centers in Tabriz-Iran from November 2017 to May 2018', 'mothers with previous unsuccessful breastfeeding']","['breastfeeding counseling sessions', 'control group merely received routine care', 'Breastfeeding counseling and mother support provision', 'prenatal counseling']","['frequency of exclusive breastfeeding', 'probability of exclusive breastfeeding', 'mean infant weight on day 15 postpartum', 'frequency of exclusive breastfeeding and infant weight gain', 'exclusive breastfeeding frequency and infant weight gain', 'infant weight gain']","[{'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",108.0,0.0492796,"No statistically significant difference was observed between the groups in terms of infant weight gain in months 2 (p = .221) and 4 (p = .128) postpartum.
","[{'ForeName': 'Fahimeh Shafaei', 'Initials': 'FS', 'LastName': 'Sehhatie', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Havizari', 'Affiliation': 'Student Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]","The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians",['10.1080/14767058.2019.1579191']
3146,31071047,Biomechanical Evaluation of Three-Dimensional Printed Dynamic Hand Device for Patients With Chronic Stroke.,"Provision of adequate task-oriented training can be difficult for stroke survivors with limited hand movement. The current passive devices are mainly intended for gross grasp and release training. Additional assistive devices are required to improve functional opposition. This paper investigated the functional recovery of chronic stroke patients after using a three-dimensional (3D) printed dynamic hand device (3D-DHD) as an adjunct to conducting a task-oriented approach (TOA). Ten participants were randomly assigned to either the 3D-DHD group (n = 5) or the control group (n = 5). The TOA was used for the 3D-DHD group by using the 3D-DHD twice a week for four weeks, followed by a two-week home program. Only the TOA was used for the control group. The outcome measures, including the box and blocks test (BBT) of manual dexterity and prehensile strength, were conducted at baseline and at follow-up at four and six weeks later. The 3D-DHD group exhibited significantly superior improvements to the control group in the BBT and the palmar pinch force test. Both the groups had significant within-group improvements in the BBT and in all strength measures compared with baseline measurements. The use of 3D-DHD could position stroke-affected hands in coordinated functional opposition and had the potential to facilitate manual dexterity and advanced prehensile movement.",2019,The 3D-DHD group exhibited significantly superior improvements to the control group in the BBT and the palmar pinch force test.,"['chronic stroke patients', 'Patients With Chronic Stroke']","['three-dimensional (3D) printed dynamic hand device (3D-DHD', '3D-DHD', 'adequate task-oriented training', 'TOA', 'Three-Dimensional Printed Dynamic Hand Device']","['BBT', 'box and blocks test (BBT) of manual dexterity and prehensile strength']","[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0344247', 'cui_str': 'Dissociated horizontal deviation'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}]",10.0,0.0220944,The 3D-DHD group exhibited significantly superior improvements to the control group in the BBT and the palmar pinch force test.,"[{'ForeName': 'Tsung-Yi', 'Initials': 'TY', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Li-Ling Hope', 'Initials': 'LH', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Wen-Wen', 'Initials': 'WW', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Pi-Chang', 'Initials': 'PC', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Chen-Sheng', 'Initials': 'CS', 'LastName': 'Chen', 'Affiliation': ''}]",IEEE transactions on neural systems and rehabilitation engineering : a publication of the IEEE Engineering in Medicine and Biology Society,['10.1109/TNSRE.2019.2915260']
3147,30793734,Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial.,"AIMS


After percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment.
METHODS AND RESULTS


In the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35-0.63) for 110 mg and 0.67 (0.50-0.90) for 150 mg]; elective PCI [0.57 (0.43-0.76) for 110 mg and 0.76 (0.56-1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28-0.76) for 110 mg and 0.59 (0.34-1.04) for 150 mg]; or clopidogrel [0.51 (0.41-0.64) for 110 mg and 0.73 (0.58-0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.
CONCLUSION


The benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.",2019,"Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.
","['patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving', 'atrial fibrillation patients with or without acute coronary syndrome', 'patients with atrial fibrillation', '2725 patients']","['dabigatran 110\u2009mg or 150\u2009mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin', 'dabigatran dual therapy', 'ticagrelor or clopidogrel', 'ticagrelor', 'percutaneous coronary intervention (PCI', 'warfarin triple therapy']","['risk of the primary endpoint, major or clinically relevant non-major bleeding event', 'bleeding risks', 'elective PCI', 'death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",2725.0,0.0370188,"Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.
","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Dag Hammarskjölds väg 38, SE-751 85 Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, an F-CRIN Network, Université Paris Diderot, INSERM U_1148 and Hôpital Bichat Assistance Publique, Paris, France.'}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Medicine, Division of Cardiology, Johann Wolfgang Goethe University, Theodor Stern-Kai 7, DE-60590 Frankfurt/Main, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, TA CardioMetabolism, Binger Str. 173, Ingelheim, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, TA CardioMetabolism, Binger Str. 173, Ingelheim, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Boehringer Ingelheim International GmbH, TA CardioMetabolism, Binger Str. 173, Ingelheim, Germany.'}, {'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Ziekenhuis, Koekoekslaan 1, Nieuwegein 3435 CM, The Netherlands.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA, USA.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital, Heart and Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA, USA.""}]",European heart journal,['10.1093/eurheartj/ehz059']
3148,31150295,Reduction in Suicidal Ideation from Prolonged Exposure Therapy for Adolescents.,"OBJECTIVE


Adolescents with posttraumatic stress disorder (PTSD) are at higher risk for suicide compared to adolescents without PTSD. This study aimed to explore whether PTSD treatment reduces suicidal ideation in adolescents and whether the degree of reduction in PTSD was associated with reduction in suicidal ideation.
METHODS


Adolescent females with PTSD from a sexual assault (55% Black, 15.3 years,  SD  = 1.5) were randomized to either prolonged exposure therapy for adolescents (PE-A,  n = 31) or client-centered therapy (CCT,  n  = 30). They reported on suicidal ideation, depression and PTSD at pre- and post-treatment, every therapy session, and follow-up, and about 40% endorsed suicidal ideation at baseline.
RESULTS


There was a significant reduction in a single-item measure of suicidal ideation during treatment across all participants. The Time in Treatment × Condition interaction was significant ( p  < .05,  d  = 0.52), indicating a significantly steeper reduction in suicidal ideation in PE-A compared to in CCT. The degree of reduction in PTSD ( p s < .05,  d  = 0.26-0.54) and depression symptoms ( p s  <  .05,  d  = 0.54-0.81) in treatment and follow-up was associated with the speed of suicidal ideation reduction in treatment and follow-up.
CONCLUSIONS


Adolescents randomized to PE-A had significantly faster reductions in suicidal ideation compared to those randomized to CCT. Greater reduction in PTSD and depression symptoms were associated with faster reduction in suicidal ideation. Clinically, this study demonstrates that adolescents who have suicidal ideation without current intent may benefit from PE-A.",2019,"The degree of reduction in PTSD ( p s < .05,  d  = 0.26-0.54) and depression symptoms ( p s  <  .05,  d  = 0.54-0.81) in treatment and follow-up was associated with the speed of suicidal ideation reduction in treatment and follow-up.
","['Adolescent females with PTSD from a sexual assault (55% Black, 15.3 years,  SD  = 1.5', 'Adolescents', 'Adolescents with posttraumatic stress disorder (PTSD']","['prolonged exposure therapy for adolescents (PE-A,  n = 31) or client-centered therapy (CCT', 'PTSD']","['suicidal ideation, depression and PTSD', 'single-item measure of suicidal ideation', 'speed of suicidal ideation reduction', 'degree of reduction in PTSD', 'PTSD and depression symptoms', 'depression symptoms', 'suicidal ideation', 'Suicidal Ideation']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028302', 'cui_str': 'Nondirective Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0229353,"The degree of reduction in PTSD ( p s < .05,  d  = 0.26-0.54) and depression symptoms ( p s  <  .05,  d  = 0.54-0.81) in treatment and follow-up was associated with the speed of suicidal ideation reduction in treatment and follow-up.
","[{'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Brown', 'Affiliation': 'a Department of Psychiatry , University of Pennsylvania.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Belli', 'Affiliation': 'a Department of Psychiatry , University of Pennsylvania.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'a Department of Psychiatry , University of Pennsylvania.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Capaldi', 'Affiliation': 'a Department of Psychiatry , University of Pennsylvania.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'a Department of Psychiatry , University of Pennsylvania.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1614003']
3149,31122856,"Effectiveness of the 10-valent pneumococcal conjugate vaccine among girls, boys, preterm and low-birth-weight infants - Results from a randomized, double-blind vaccine trial.","BACKGROUND


Several studies have shown differences in susceptibility to infections and immune response to vaccines by sex. Prematurely born infants are at higher risk for pneumococcal diseases, with lower effectiveness for some vaccines compared to term infants. We have reported the effectiveness of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on several endpoints in the Finnish Invasive Pneumococcal disease (FinIP) vaccine trial. Now, we present the results of a post-hoc analysis evaluating PHiD-CV10 effectiveness in subgroups by sex, gestational age, and birth weight.
METHODS


The FinIP trial was a phase III/IV cluster-randomized, double-blind trial. Infants enrolled < 7 months of age received PHiD-CV10 in two thirds of clusters (3 + 1 or 2 + 1 schedule) and hepatitis B vaccine as control in remaining third. Outcome data included invasive pneumococcal disease, pneumonia, tympanostomy tube placements, and antimicrobial purchases collected through national, routinely used health registers. Negative binomial model was used in the incidence and vaccine effectiveness estimation, and differences in incidences between subgroups were tested among control children.
RESULTS


Of the 30,527 infants enrolled 51% were boys. The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups. There were no significant sex differences in the vaccine effectiveness estimates. Altogether, 1519 (5%) infants were born before 37th gestational week. The incidences of pneumonia outcomes were higher among premature infants when compared to term infants. The vaccine effectiveness estimates among preterm infants were not statistically significant except for antimicrobial purchases, but all point estimates were at the same level among preterm infants as among term infants. There was no significant difference between 2 + 1 and 3 + 1 schedules in any of the subgroups analysed.
CONCLUSION


PHiD-CV10 had a similar effectiveness in both sexes, and seemed to be protective in preterm infants.
TRIAL REGISTRATION


ClinicalTrials.gov NCT00861380 and NCT00839254.",2019,The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups.,"['girls, boys, preterm and low-birth-weight infants ', '30,527 infants enrolled 51% were boys', 'Infants enrolled\u202f<\u202f7\u202fmonths of age received', 'Finnish Invasive Pneumococcal disease (FinIP) vaccine trial', 'preterm infants']","['hepatitis B vaccine', '10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10', '10-valent pneumococcal conjugate vaccine', 'PHiD-CV10']","['incidences of hospital-diagnosed pneumonia and otitis-related outcomes', 'invasive pneumococcal disease, pneumonia, tympanostomy tube placements, and antimicrobial purchases collected through national, routinely used health registers', 'incidences of pneumonia outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0450819', 'cui_str': 'CV10 (body structure)'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0029877', 'cui_str': 'Ear Inflammation'}, {'cui': 'C1320214', 'cui_str': 'Invasive Streptococcus pneumoniae disease'}, {'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]",51.0,0.561733,The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups.,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nieminen', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, FinnMedi I, Biokatu 6, FI-33520 Tampere, Finland. Electronic address: heta.nieminen@thl.fi.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rinta-Kokko', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Puumalainen', 'Affiliation': 'Department of Health Security, National Institute for Health and Welfare, P.O. Box 30, FI-00271 Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Moreira', 'Affiliation': 'GSK, Avenue Fleming 20, B-1300 Wavre, Belgium.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Avenue Fleming 20, B-1300 Wavre, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GSK, Avenue Fleming 20, B-1300 Wavre, Belgium.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Palmu', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, FinnMedi I, Biokatu 6, FI-33520 Tampere, Finland.'}]",Vaccine,['10.1016/j.vaccine.2019.05.033']
3150,31755906,Cognitive Behavioral Treatments for Anxiety in Children With Autism Spectrum Disorder: A Randomized Clinical Trial.,"Importance


Anxiety is common among youth with autism spectrum disorder (ASD), often interfering with adaptive functioning. Psychological therapies are commonly used to treat school-aged youth with ASD; their efficacy has not been established.
Objective


To compare the relative efficacy of 2 cognitive behavioral therapy (CBT) programs and treatment as usual (TAU) to assess treatment outcomes on maladaptive and interfering anxiety in children with ASD. The secondary objectives were to assess treatment outcomes on positive response, ASD symptom severity, and anxiety-associated adaptive functioning.
Design, Setting, and Participants


This randomized clinical trial began recruitment in April 2014 at 3 universities in US cities. A volunteer sample of children (7-13 years) with ASD and maladaptive and interfering anxiety was randomized to standard-of-practice CBT, CBT adapted for ASD, or TAU. Independent evaluators were blinded to groupings. Data were collected through January 2017 and analyzed from December 2018 to February 2019.
Interventions


The main features of standard-of-practice CBT were affect recognition, reappraisal, modeling/rehearsal, in vivo exposure tasks, and reinforcement. The CBT intervention adapted for ASD was similar but also addressed social communication and self-regulation challenges with perspective-taking training and behavior-analytic techniques.
Main Outcomes and Measures


The primary outcome measure per a priori hypotheses was the Pediatric Anxiety Rating Scale. Secondary outcomes included treatment response on the Clinical Global Impressions-Improvement scale and checklist measures.
Results


Of 214 children initially enrolled, 167 were randomized, 145 completed treatment, and 22 discontinued participation. Those who were not randomized failed to meet eligibility criteria (eg, confirmed ASD). There was no significant difference in discontinuation rates across conditions. Randomized children had a mean (SD) age of 9.9 (1.8) years; 34 were female (20.5%). The CBT program adapted for ASD outperformed standard-of-practice CBT (mean [SD] Pediatric Anxiety Rating Scale score, 2.13 [0.91] [95% CI, 1.91-2.36] vs 2.43 [0.70] [95% CI, 2.25-2.62]; P = .04) and TAU (2.93 [0.59] [95% CI, 2.63-3.22]; P < .001). The CBT adapted for ASD also outperformed standard-of-practice CBT and TAU on parent-reported scales of internalizing symptoms (estimated group mean differences: adapted vs standard-of-practice CBT, -0.097 [95% CI, -0.172 to -0.023], P = .01; adapted CBT vs TAU, -0.126 [95% CI, -0.243 to -0.010]; P = .04), ASD-associated social-communication symptoms (estimated group mean difference: adapted vs standard-of-practice CBT, -0.115 [95% CI, -0223 to -0.007]; P = .04; adapted CBT vs TAU: -0.235 [95% CI,-0.406 to -0.065]; P = .01); and anxiety-associated social functioning (estimated group mean difference: adapted vs standard-of-practice CBT, -0.160 [95% CI, -0.307 to -0.013]; P = .04; adapted CBT vs TAU: -0.284 [95% CI, -0.515 to -0.053]; P = .02). Both CBT conditions achieved higher rates of positive treatment response than TAU (BIACA, 61 of 66 [92.4%]; Coping Cat, 47 of 58 [81.0%]; TAU, 2 of 18 [11.1%]; P < .001 for each comparison).
Conclusions and Relevance


In this study, CBT was efficacious for children with ASD and interfering anxiety, and an adapted CBT approach showed additional advantages. It is recommended that clinicians providing psychological treatments to school-aged children with ASD consider developing CBT expertise.
Trial Registration


ClinicalTrials.gov identifier: NCT02028247.",2020,"The CBT adapted for ASD also outperformed standard-of-practice CBT and TAU on parent-reported scales of internalizing symptoms (estimated group mean differences: adapted vs standard-of-practice CBT, -0.097","['214 children initially enrolled, 167 were randomized, 145 completed treatment, and 22 discontinued participation', 'A volunteer sample of children (7-13 years) with ASD and maladaptive and interfering anxiety', 'youth with autism spectrum disorder (ASD', 'April 2014 at 3 universities in US cities', 'children with ASD', 'Randomized children had a mean (SD) age of 9.9 (1.8) years; 34 were female (20.5', 'school-aged children with ASD', 'Spectrum Disorder', 'Data were collected through January 2017 and analyzed from December 2018 to February 2019', 'Children With Autism', 'school-aged youth with ASD']","['Cognitive Behavioral Treatments', 'standard-of-practice CBT, CBT adapted for ASD, or TAU', 'cognitive behavioral therapy (CBT) programs and treatment as usual (TAU', 'CBT']","['treatment response on the Clinical Global Impressions-Improvement scale and checklist measures', 'positive response, ASD symptom severity, and anxiety-associated adaptive functioning', 'internalizing symptoms', 'discontinuation rates', 'Pediatric Anxiety Rating Scale', 'anxiety-associated social functioning', 'ASD-associated social-communication symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",214.0,0.139419,"The CBT adapted for ASD also outperformed standard-of-practice CBT and TAU on parent-reported scales of internalizing symptoms (estimated group mean differences: adapted vs standard-of-practice CBT, -0.097","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Wood', 'Affiliation': 'Department of Education, University of California, Los Angeles, Los Angeles.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Karen S', 'Initials': 'KS', 'LastName': 'Wood', 'Affiliation': 'Department of Psychiatry, University of California, Los Angeles, Los Angeles.'}, {'ForeName': 'Connor M', 'Initials': 'CM', 'LastName': 'Kerns', 'Affiliation': 'Department of Psychology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Seltzer', 'Affiliation': 'Department of Education, University of California, Los Angeles, Los Angeles.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Small', 'Affiliation': 'University of South Florida School of Aging Studies, Tampa.'}, {'ForeName': 'Adam B', 'Initials': 'AB', 'LastName': 'Lewin', 'Affiliation': 'Departments of Pediatrics and Psychiatry, University of South Florida, Tampa.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4160']
3151,31159674,Feasibility and Acceptability of the Youth Aware of Mental Health (YAM) Intervention in US Adolescents.,"Suicide is the second leading cause of death among US adolescents, and rates of suicide among youth have been increasing for the past decade. This study assessed the feasibility and acceptability of the universal, school-based Youth Aware of Mental Health (YAM) program, a promising mental health promotion and suicide primary prevention intervention, in US youth. Using an uncontrolled design, the feasibility and acceptability of delivering and studying YAM were assessed in Montana and Texas schools. Thirteen of 16 (81.3%) schools agreed to support YAM delivery, and five Montana and 6 Texas schools were included in analyses. Facilitators delivered YAM in 78 classes (1,878 students) as regular high school curriculum. Of the total number of students who received YAM, 519 (27.6%) provided parental consent and assent. 436 (84.0%) consented students participated in pre- and post-surveys. Students, parents, and school staff found YAM highly acceptable based on satisfaction surveys. In summary, this study found YAM feasible to implement in US schools. Results also suggest students, parents, and school staff supported school-based programs and were highly satisfied with the YAM program. A randomized controlled trial is warranted to test the efficacy of YAM in promoting mental health and preventing suicidal thoughts and behaviors in US adolescents.",2020,"Results also suggest students, parents, and school staff supported school-based programs and were highly satisfied with the YAM program.","['436 (84.0%) consented students participated in pre- and post-surveys', 'US adolescents', 'in 78 classes (1,878 students) as regular high school curriculum', 'US Adolescents', 'Thirteen of 16 (81.3%) schools agreed to support YAM delivery, and five Montana and 6 Texas schools']","['YAM', 'Mental Health (YAM) Intervention']",['feasibility and acceptability of delivering and studying YAM'],"[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0936043', 'cui_str': 'Dioscorea'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026506', 'cui_str': 'Montana'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0936043', 'cui_str': 'Dioscorea'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0936043', 'cui_str': 'Dioscorea'}]",,0.0297517,"Results also suggest students, parents, and school staff supported school-based programs and were highly satisfied with the YAM program.","[{'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lindow', 'Affiliation': ''}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hughes', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'South', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gutierrez', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bannister', 'Affiliation': ''}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': ''}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Byerly', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2019.1624667']
3152,31219698,Randomized Trial of a Single-Session Growth Mind-Set Intervention for Rural Adolescents' Internalizing and Externalizing Problems.,"Adolescents living in rural regions of the United States face substantial barriers to accessing mental health services, creating needs for more accessible, nonstigmatizing, briefer interventions. Research suggests that single-session ""growth mind-set"" interventions (GM-SSIs)-which teach the belief that personal traits are malleable through effort-may reduce internalizing and externalizing problems in adolescents. However, GM-SSIs have not been evaluated among rural youth, and their effects on internalizing and externalizing problems have not been assessed within a single trial, rendering their relative benefits for different problem types unclear. We examined whether a computerized GM-SSI could reduce depressive symptoms, social anxiety symptoms, and conduct problems in female adolescents from rural areas of the United States. Tenth-grade female adolescents ( N  = 222,  M  age = 15.2, 38% White, 25% Black, 29% Hispanic) from 4 rural, low-income high schools in the southeastern United States were randomized to receive a 45-min GM-SSI or a computer-based active control program, teaching healthy sexual behaviors. Young women self-reported depression symptoms, social anxiety symptoms, and conduct problem behaviors at baseline and 4-month follow-up. Relative to the female students in the control group, the students receiving the GM-SSI reported modest but significantly greater reductions in depressive symptoms ( d  = .23) and likelihood of reporting elevated depressive symptoms ( d  = .29) from baseline to follow-up. GM-SSI effects were nonsignificant for social anxiety symptoms, although a small effect size emerged in the hypothesized direction ( d  = .21), and nonsignificant for change in conduct problems ( d  = .01). A free-of-charge 45-min GM-SSI may help reduce internalizing distress, especially depression-but not conduct problems-in rural female adolescents.",2019,"Relative to the female students in the control group, the students receiving the GM-SSI reported modest but significantly greater reductions in depressive symptoms ( d  = .23) and likelihood of reporting elevated depressive symptoms ( d  = .29) from baseline to follow-up.","[""Rural Adolescents' Internalizing and Externalizing Problems"", 'adolescents', '15.2, 38% White, 25% Black, 29% Hispanic) from 4 rural, low-income high schools in the southeastern United States', 'rural female adolescents', 'Tenth-grade female adolescents ( N  =\xa0222,  M  age\xa0', 'Adolescents living in rural regions', 'female adolescents from rural areas of the United States']","['45-min GM-SSI or a computer-based active control program', 'Single-Session Growth Mind-Set Intervention', 'computerized GM-SSI']","['depressive symptoms, social anxiety symptoms', 'depression symptoms, social anxiety symptoms, and conduct problem behaviors', 'depressive symptoms', 'social anxiety symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205444', 'cui_str': 'Tenth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]",,0.138163,"Relative to the female students in the control group, the students receiving the GM-SSI reported modest but significantly greater reductions in depressive symptoms ( d  = .23) and likelihood of reporting elevated depressive symptoms ( d  = .29) from baseline to follow-up.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'a Department of Psychology , Stony Brook University.'}, {'ForeName': 'Jeni L', 'Initials': 'JL', 'LastName': 'Burnette', 'Affiliation': 'b Department of Psychology , North Carolina State University.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Widman', 'Affiliation': 'b Department of Psychology , North Carolina State University.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Hoyt', 'Affiliation': 'c Jepson School of Leadership Studies , University of Richmond.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Prinstein', 'Affiliation': 'd Department of Psychology , University of North Carolina-Chapel Hill.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2019.1622123']
3153,31917424,Association Between 21-Gene Assay Recurrence Score and Locoregional Recurrence Rates in Patients With Node-Positive Breast Cancer.,"Importance


The 21-gene assay recurrence score is increasingly used to personalize treatment recommendations for systemic therapy in postmenopausal women with estrogen receptor (ER)- or progesterone receptor (PR)-positive, node-positive breast cancer; however, the relevance of the 21-gene assay to radiotherapy decisions remains uncertain.
Objective


To examine the association between recurrence score and locoregional recurrence (LRR) in a postmenopausal patient population treated with adjuvant chemotherapy followed by tamoxifen or tamoxifen alone.
Design, Setting, and Participants


This cohort study was a retrospective analysis of the Southwest Oncology Group S8814, a phase 3 randomized clinical trial of postmenopausal women with ER/PR-positive, node-positive breast cancer treated with tamoxifen alone, chemotherapy followed by tamoxifen, or concurrent tamoxifen and chemotherapy. Patients at North American clinical centers were enrolled from June 1989 to July 1995. Medical records from patients with recurrence score information were reviewed for LRR and radiotherapy use. Primary analysis included 316 patients and excluded 37 who received both mastectomy and radiotherapy, 9 who received breast-conserving surgery without documented radiotherapy, and 5 with unknown surgical type. All analyses were performed from January 22, 2016, to August 9, 2019.
Main Outcomes and Measures


The LRR was defined as a recurrence in the breast; chest wall; or axillary, infraclavicular, supraclavicular, or internal mammary lymph nodes. Time to LRR was tested with log-rank tests and Cox proportional hazards regression for multivariate models.
Results


The final cohort of this study comprised 316 women with a mean (range) age of 60.4 (44-81) years. Median (interquartile range) follow-up for those without LRR was 8.7 (7.0-10.2) years. Seven LRR events (5.8%) among 121 patients with low recurrence score and 27 LRR events (13.8%) among 195 patients with intermediate or high recurrence score occurred. The estimated 10-year cumulative incidence rates were 9.7% for those with a low recurrence score and 16.5% for the group with intermediate or high recurrence score (P = .02). Among patients who had a mastectomy without radiotherapy (n = 252), the differences in the 10-year actuarial LRR rates remained significant: 7.7 % for the low recurrence score group vs 16.8% for the intermediate or high recurrence score group (P = .03). A multivariable model controlling for randomized treatment, number of positive nodes, and surgical type showed that a higher recurrence score was prognostic for LRR (hazard ratio [HR], 2.36; 95% CI, 1.02-5.45; P = .04). In a subset analysis of patients with a mastectomy and 1 to 3 involved nodes who did not receive radiation therapy, the group with a low recurrence score had a 1.5% rate of LRR, whereas the group with an intermediate or high recurrence score had a 11.1% LRR (P = .051).
Conclusions and Relevance


This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes. This finding suggests that the recurrence score may be used, along with accepted clinical variables, to assess the risk of LRR during radiotherapy decision-making.",2020,"This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes.","[' and 5 with unknown surgical type', 'Patients at North American clinical centers were enrolled from June 1989 to July 1995', '316 women with a mean (range) age of 60.4 (44-81) years', '316 patients and excluded 37 who received both', 'patients with recurrence score information', 'postmenopausal women with ER/PR-positive, node-positive breast cancer treated with', 'Patients With Node-Positive Breast Cancer', 'postmenopausal women with estrogen receptor (ER)- or progesterone receptor (PR)-positive, node-positive breast cancer', 'postmenopausal patient population treated with adjuvant chemotherapy followed by']","['tamoxifen alone, chemotherapy followed by tamoxifen, or concurrent tamoxifen and chemotherapy', 'tamoxifen or tamoxifen alone', 'mastectomy without radiotherapy', 'breast-conserving surgery without documented radiotherapy', 'mastectomy and radiotherapy']","['10-year actuarial LRR rates', '10-year cumulative incidence rates', 'recurrence score and locoregional recurrence (LRR', 'Seven LRR events', '21-Gene Assay Recurrence Score and Locoregional Recurrence Rates', 'higher recurrence scores', 'LRR', 'rate of LRR']","[{'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0034833', 'cui_str': 'Receptors, Progestin'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",316.0,0.127522,"This study found that higher recurrence scores were associated with increased LRR after adjustment for treatment, type of surgical procedure, and number of positive nodes.","[{'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Woodward', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Barlow', 'Affiliation': 'Cancer Research and Biostatics, Seattle, Washington.'}, {'ForeName': 'Reshma', 'Initials': 'R', 'LastName': 'Jagsi', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchholz', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Shak', 'Affiliation': 'Department of Pathology, Genomic Health Inc, Redwood City, California.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Baehner', 'Affiliation': 'Department of Pathology, Genomic Health Inc, Redwood City, California.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Davidson', 'Affiliation': 'Division of Medical Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Tari A', 'Initials': 'TA', 'LastName': 'King', 'Affiliation': 'Department of Surgery, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Ravdin', 'Affiliation': 'Department of Medicine, Cancer Therapy & Research Center, University of Texas Health Science Center, San Antonio.'}, {'ForeName': 'C Kent', 'Initials': 'CK', 'LastName': 'Osborne', 'Affiliation': 'Department of Medicine, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': 'Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Livingston', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Arizona, Tucson.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington/Seattle Cancer Care Alliance, Seattle.'}, {'ForeName': 'Gabriel N', 'Initials': 'GN', 'LastName': 'Hortobagyi', 'Affiliation': 'Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hayes', 'Affiliation': 'Department of Internal Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois.'}]",JAMA oncology,['10.1001/jamaoncol.2019.5559']
3154,31207030,"Effect of tadalafil 5 mg on post-micturition dribble in men with lower urinary tract symptoms: a multicentre, double-blind, randomized, placebo-controlled trial.","OBJECTIVES


To compare the effects of taking tadalafil 5 mg and placebo once daily on post-micturition dribble (PMD) in men with lower urinary tract symptoms (LUTS).
PATIENTS AND METHODS


Our prospective, randomized, double-blind, placebo-controlled, multicentre trial enrolled 102 men with PMD and other LUTS. PMD was assessed using the Hallym Post-Micturition Dribble Questionnaire (HPMDQ) and according to PMD volume. Over a 12-week period, patients took either tadalafil 5 mg (n = 51) or placebo (n = 51) once daily and their HPMDQ and PMD volume results were evaluated. Adverse events (AEs) were also reported.
RESULTS


Over the course of 12 weeks, total HPMDQscores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score of ≥2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients (P < 0.001) and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22  mL, respectively (P = 0.046). Specifically, PMD frequency decreased and quality of life increased significantly more in the tadalafil group than in the placebo group (P = 0.029 and P < 0.001, respectively). Furthermore, 66.7% of the tadalafil group reported moderate and significant PMD improvement, whereas only 4.2% reported that tadalafil was ineffective. Treatment-emergent AEs did not significantly differ between the groups (all P > 0.05), and no serious AEs were observed.
CONCLUSION


Taking tadalafil 5 mg once daily reduced PMD symptom severity and PMD volume in men with PMD, without inducing serious AEs, more effectively than placebo, suggesting that taking tadalafil 5 mg once daily may be an effective and well-tolerated PMD treatment.",2019,"Over 12 weeks, the total HPMDQ scores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score by ≥ 2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients, p < 0.001 and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22 mL, p = 0.046, respectively).","['men with lower urinary tract symptoms', 'male PMD patients', 'men with lower urinary tract symptoms (LUTSs', '102 male patients with PMD and other LUTSs']","['tadalafil', 'placebo', 'placebos', 'tadalafil 5mg and placebos']","['total HPMDQ scores and PMD volumes', 'PMD symptom severity and PMD volume', 'total HPMDQ score', 'Hallym PostMicturition Dribble Questionnaire (HPMDQ) and using PMD volume', 'quality of life', 'PMD', 'mean PMD volume', 'PMD frequency', 'moderate and significant PMD improvement']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1594297', 'cui_str': 'tadalafil 5 MG [Cialis]'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",102.0,0.441844,"Over 12 weeks, the total HPMDQ scores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score by ≥ 2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients, p < 0.001 and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22 mL, p = 0.046, respectively).","[{'ForeName': 'Dae Yul', 'Initials': 'DY', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Jeong', 'Affiliation': 'Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, Korea.'}, {'ForeName': 'Kyungtae', 'Initials': 'K', 'LastName': 'Ko', 'Affiliation': 'Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, Korea.'}, {'ForeName': 'Seong Ho', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Dongtan Sacred Heart Hospital, Hallym Unversity, Hwaseong, Korea.'}, {'ForeName': 'Sang Kon', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, Korea.'}, {'ForeName': 'Tae Young', 'Initials': 'TY', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, Korea.'}, {'ForeName': 'Jin Seon', 'Initials': 'JS', 'LastName': 'Cho', 'Affiliation': 'Department of Urology, College of Medicine, Hallym University Sacred Heart Hospital, Hallym Unversity, Anyang, Korea.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, Korea.'}]",BJU international,['10.1111/bju.14849']
3155,31264903,Extrication Times During Avalanche Companion Rescue: A Randomized Single-Blinded Manikin Study.,"Aims:  This study aimed to determine the time needed for one or two companion rescuers to access, extricate, and deliver cardiopulmonary resuscitation (CPR) to a fully buried manikin during a simulated avalanche burial scenario.  Materials and Methods:  In this randomized, single-blinded study, 18 medical students were required to extricate a manikin manually from a simulated avalanche burial of 1 m in depth, either alone or in teams of two. Each participant performed three consecutive tests with the manikin in three different positions in random order.  Results:  Median time to first manikin contact was 2.5 minutes, median time to airway access 7.2 minutes, and median time to standard position for CPR 10.1 minutes. Overall, the number of rescuers (one compared to two rescuers, 10.5 minutes vs. 9.3 minutes;  p  = 0.686) and the burial position of the manikin (10.8 minutes vs. 10.6 minutes vs. 8.8 minutes;  p  = 0.428) had no influence on extrication times. Preexisting training (6.1 minutes vs. 11.0 minutes  p  = 0.006) and a learning effect obtained during the experiments (12.4 minutes the first test vs. 9.3 in the third test;  p  = 0.017) improved all extrication times.  Conclusion:  It takes an average of 7 minutes after location of a simulated avalanche victim, buried at a depth of 1 m, to free the airway, plus a further 3 minutes to initiate CPR in standard supine position. This is more than two-thirds of the 15 minutes considered necessary for successful companion avalanche rescue. Even minimal training significantly reduced extrication times. These findings emphasize the importance of regular practice in specific extrication techniques that should be part of any training in avalanche companion rescue.",2019,Preexisting training (6.1 minutes vs. 11.0 minutes  p  = 0.006) and a learning effect obtained during the experiments (12.4 minutes the first test vs. 9.3 in the third test;  p  = 0.017) improved all extrication times.  ,"['18 medical students were required to extricate a manikin manually from a simulated avalanche burial of 1\u2009m in depth, either alone or in teams of two']","['Avalanche Companion Rescue', 'extricate, and deliver cardiopulmonary resuscitation (CPR']","['burial position of the manikin', 'number of rescuers', 'extrication times', 'median time to airway access 7.2 minutes, and median time to standard position', 'Median time to first manikin contact']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0337014', 'cui_str': 'Avalanches'}, {'cui': 'C0006407', 'cui_str': 'Burial'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]","[{'cui': 'C0337014', 'cui_str': 'Avalanches'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}]","[{'cui': 'C0006407', 'cui_str': 'Burial'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",18.0,0.0246786,Preexisting training (6.1 minutes vs. 11.0 minutes  p  = 0.006) and a learning effect obtained during the experiments (12.4 minutes the first test vs. 9.3 in the third test;  p  = 0.017) improved all extrication times.  ,"[{'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wallner', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Clinic Innsbruck, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Moroder', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, General Hospital Brixen, Brixen, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Clinic Innsbruck, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mair', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Clinic Innsbruck, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Erhart', 'Affiliation': 'Department of Orthopaedics and Traumatology, University Hospital Hall in Tirol, Hall in Tirol, Austria.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Bachler', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Clinic Innsbruck, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Putzer', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, University Clinic Innsbruck, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Turner', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Strapazzon', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Falk', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Brugger', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy.'}]",High altitude medicine & biology,['10.1089/ham.2019.0021']
3156,31932171,Fractional Flow Reserve Derived from Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain: Rationale and Design of the FORECAST Trial.,"BACKGROUND


Fractional flow reserve measurement based on computed tomography (FFR CT ) is a novel, well validated, non-invasive method for determining the presence and extent of coronary artery disease (CAD) combined with a physiological assessment of vessel-specific ischemia in patients with chest pain. Previous studies indicate that FFR CT  reduces the uptake of invasive angiography that shows no significant CAD, without compromising patient safety. The clinical effectiveness and economic impact of using FFR CT  instead of other tests in the initial evaluation of patients with stable chest pain has not been tested in a randomized trial.
METHODS


The FORECAST trial will randomise 1400 patients with stable chest pain to receive either FFR CT  or routine clinical assessment as directed by the National Institute for Health and Care Excellence (NICE) CG95 guideline for Chest Pain of Recent Onset. The primary endpoint will be resource utilisation over the subsequent nine months, including non-invasive cardiac investigations, invasive coronary angiography, coronary revascularization, hospitalization for cardiac events, and the use of cardiac medications. Key pre-specified secondary endpoints will be major adverse cardiac events, angina severity, quality of life, patient satisfaction, time to definitive management plan, time to completion of initial evaluation, number of hospital attendances, and working days lost in patients who are in employment.
CONCLUSION


The FORECAST randomized trial will assess the clinical and economic outcomes of using FFR CT  as the primary test to evaluate patients presenting with stable chest pain.",2020,"Previous studies indicate that FFR CT  reduces the uptake of invasive angiography that shows no significant CAD, without compromising patient safety.","['1400 patients with stable chest pain to receive either', 'patients presenting with stable chest pain', 'stable chest pain', 'patients with stable chest pain', 'patients with chest pain']","['FFR CT', 'Fractional flow reserve measurement based on computed tomography (FFR CT ', 'Fractional flow reserve derived from computed tomography coronary angiography', 'FFR CT  or routine clinical assessment as directed by the National Institute for Health and Care Excellence (NICE) CG95 guideline']","['major adverse cardiac events, angina severity, quality of life, patient satisfaction, time to definitive management plan, time to completion of initial evaluation, number of hospital attendances, and working days lost in patients who are in employment', 'resource utilisation over the subsequent nine months, including non-invasive cardiac investigations, invasive coronary angiography, coronary revascularization, hospitalization for cardiac events, and the use of cardiac medications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]",1400.0,0.0762478,"Previous studies indicate that FFR CT  reduces the uptake of invasive angiography that shows no significant CAD, without compromising patient safety.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mahmoudi', 'Affiliation': 'Faculty of Medicine, University of Southampton, UK.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Nicholas', 'Affiliation': 'Coronary Research Group, University Hospital Southampton, Southampton, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Nuttall', 'Affiliation': 'Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Maishman', 'Affiliation': 'Clinical Trials Unit, University of Southampton, Southampton, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Hlatky', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Douglas', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Rajani', 'Affiliation': ""Guy's & St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Fox', 'Affiliation': 'Imperial College, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Curzen', 'Affiliation': 'Faculty of Medicine, University of Southampton, UK; Coronary Research Group, University Hospital Southampton, Southampton, UK. Electronic address: Nick.curzen@uhs.nhs.uk.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.12.009']
3157,31961377,Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study.,"Importance


Prescription opioids play a significant role in the ongoing opioid crisis. Guidelines and physician education have had mixed success in curbing opioid prescriptions, highlighting the need for other tools that can change prescriber behavior, including nudges based in behavioral economics.
Objective


To determine whether and to what extent changes in the default settings in the electronic medical record (EMR) are associated with opioid prescriptions for patients discharged from emergency departments (EDs).
Design, Setting, and Participants


This quality improvement study randomly altered, during a series of five 4-week blocks, the prepopulated dispense quantities of discharge prescriptions for commonly prescribed opioids at 2 large, urban EDs. These changes were made without announcement, and prescribers were not informed of the study itself. Participants included all health care professionals (physicians, nurse practitioners, and physician assistants) working clinically in either of the 2 EDs. Data were collected from November 28, 2016, through July 9, 2017, and analyzed from July 16, 2017, through May 14, 2018.
Interventions


Default quantities for opioids were changed from status quo quantities of 12 and 20 tablets to null, 5, 10, and 15 tablets according to a block randomization scheme. Regardless of the default quantity, each health care professional decided for whom to prescribe opioids and could modify the quantity prescribed without restriction.
Main Outcomes and Measures


The primary outcome was the number of tablets of opioid-containing medications prescribed under each default setting.
Results


A total of 104 health care professionals wrote 4320 prescriptions for opioids during the study period. Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity. When evaluating each of the 15 pairwise comparisons of default quantities (eg, 5 vs 15 tablets), a lower default was associated with a lower number of pills prescribed in more than half (8 of the 15) of the pairwise comparisons; there was a higher quantity in 1 and no difference in 6 comparisons.
Conclusions and Relevance


These findings suggest that default settings in the EMR may influence the quantity of opioids prescribed by health care professionals. This low-cost, easily implementable, EMR-based intervention could have far-reaching implications for opioid prescribing and could be used as a tool to help combat the opioid epidemic.
Trial Registration


ClinicalTrials.gov identifier: NCT04155229.",2020,"Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity.","['Data were collected from November 28, 2016, through July 9, 2017, and analyzed from July 16, 2017, through May 14, 2018', '104 health care professionals wrote 4320 prescriptions for opioids during the study period', 'patients discharged from emergency departments (EDs', 'Participants included all health care professionals (physicians, nurse practitioners, and physician assistants) working clinically in either of the 2 EDs', 'Emergency Departments']",[],['number of tablets of opioid-containing medications prescribed under each default setting'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C4517776', 'cui_str': 'Four thousand three hundred and twenty'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0031833', 'cui_str': ""Physicians' Extenders""}, {'cui': 'C0043227', 'cui_str': 'Work'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2239117', 'cui_str': 'Drug Prescribing'}]",,0.171444,"Using linear regression, an increase of 0.19 tablets prescribed (95% CI, 0.15-0.22) was found for each tablet increase in default quantity.","[{'ForeName': 'Juan Carlos C', 'Initials': 'JCC', 'LastName': 'Montoy', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}, {'ForeName': 'Zlatan', 'Initials': 'Z', 'LastName': 'Coralic', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Herring', 'Affiliation': 'Department of Emergency Medicine, Highland Hospital-Alameda Health System, Oakland, California.'}, {'ForeName': 'Eben J', 'Initials': 'EJ', 'LastName': 'Clattenburg', 'Affiliation': 'Department of Emergency Medicine, Highland Hospital-Alameda Health System, Oakland, California.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Raven', 'Affiliation': 'Department of Emergency Medicine, University of California, San Francisco.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.6544']
3158,31982095,The impact of rater training on the psychometric properties of standardized surgical skill assessment tools.,"INTRODUCTION


Competency-based frameworks are common in surgical training. However, the optimal use of standardized technical assessments is not well defined. We investigated the effect of rater training (RT) on the reliability and validity of four assessment tools.
MATERIALS AND METHODS


Forty-Seven surgeons were randomized to RT (N = 24) and no training (N = 23) groups. A task-specific checklist, pass-fail, visual analog, and OSATS global rating scale (GRS) were used to assess trainee knot-tying and suturing tasks. Delayed assessment was performed two weeks later. Internal consistency, intra/inter-rater reliability, and construct validity were measured.
RESULTS


The GRS had superior reliability and validity compared to the other tools regardless of training. No significant differences between training groups was found. However, the RT group trended to improved reliability for all tools at both assessments.
CONCLUSIONS


RT did not lead to significant improvements in skills assessments. Standardized assessments (OSATS GRS) are preferred due to their superior reliability and validity over other methods. Despite findings, we believe more effective training methods or repeated sessions may be required for sustained and significant effects.",2020,The GRS had superior reliability and validity compared to the other tools regardless of training.,['Forty-Seven surgeons'],"['rater training (RT', 'no training', 'rater training']","['skills assessments', 'Internal consistency, intra/inter-rater reliability, and construct validity', 'A task-specific checklist, pass-fail, visual analog, and OSATS global rating scale (GRS']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}]",47.0,0.0238416,The GRS had superior reliability and validity compared to the other tools regardless of training.,"[{'ForeName': 'Reagan L', 'Initials': 'RL', 'LastName': 'Robertson', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Gillman', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vergis', 'Affiliation': 'Department of Surgery, University of Manitoba, Canada. Electronic address: avergis@sbgh.mb.ca.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.01.019']
3159,31769496,Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials.,"CONTEXT


Variations in the prevalence and etiology of type 2 diabetes (T2D) across race and ethnicity may affect treatment responses. Semaglutide is a glucagon-like peptide-1 analog approved for once-weekly, subcutaneous treatment of T2D.
OBJECTIVE


To compare semaglutide efficacy and safety in race and ethnicity subgroups across the SUSTAIN trials.
DESIGN


Post hoc analysis of data from phase 3 randomized SUSTAIN 1-5 and 7 (pooled), and SUSTAIN 6 trials.
PARTICIPANTS


3074 subjects (SUSTAIN 1-5 and 7) and 1648 subjects (SUSTAIN 6).
INTERVENTIONS


Semaglutide 0.5 or 1.0 mg, placebo, or active comparator (sitagliptin 100 mg, exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg).
MAIN OUTCOME MEASURES


Change in hemoglobin A1C (HbA1c) and body weight from baseline to weeks 30, 40 and 104, and other efficacy and safety endpoints.
RESULTS


HbA1c was reduced from baseline by 1.0 to 1.5 percentage points and 1.3 to 2.0 percentage points, and body weight was reduced by 2.3 to 4.7 kg and 3.6 to 6.1 kg with semaglutide 0.5 and 1.0 mg, respectively, across race and ethnicity subgroups. Minor changes in blood pressure and lipid profiles were observed. Adverse events (AEs) were reported in similar proportions of subjects across trials. More Asian versus other race subgroups discontinued treatment prematurely due to AEs. The most commonly reported AEs were gastrointestinal disorders.
CONCLUSIONS


In this SUSTAIN trials post hoc analysis, semaglutide was associated with consistent and clinically relevant reductions in HbA1c and body weight in subjects with T2D, with minor variations in efficacy and safety outcomes associated with race or ethnicity.",2020,Semaglutide is a glucagon-like peptide-1,"['3,074 subjects (SUSTAIN 1-5 and 7); 1,648 subjects (SUSTAIN 6', 'type 2 diabetes by race and ethnicity']","['exenatide extended release 2.0 mg, insulin glargine 100IU/ml and dulaglutide 0.75 or 1.5 mg', 'semaglutide', 'Semaglutide 0.5 or 1.0 mg, placebo or active comparator (sitagliptin']","['blood pressure and lipid profiles', 'Adverse events (AEs', 'body weight', 'Change in HbA1c and body weight', 'Efficacy and safety', 'efficacy and safety endpoints']","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1648.0,0.224434,Semaglutide is a glucagon-like peptide-1,"[{'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'DeSouza', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, US.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""L'Institut du Thorax, Department of Endocrinology, CHU Nantes, Nantes, France.""}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, CO, US.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Lausvig', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Navarria', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, LA, US.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz072']
3160,31968068,Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial.,"Importance


Despite the prevalence and adverse consequences of prenatal insomnia, a paucity of research is available regarding interventions to improve insomnia symptoms during pregnancy.
Objective


To test the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) compared with standard treatment among pregnant women with insomnia symptoms.
Design, Setting, and Participants


This randomized clinical trial enrolled pregnant women from November 23, 2016, to May 22, 2018. Of the 2258 women assessed for eligibility using an online self-report questionnaire, 208 were randomized to receive digital CBT-I (n = 105) or standard treatment (n = 103) for insomnia. Participants were pregnant up to 28 weeks' gestation, and they either had elevated insomnia symptom severity or met the criteria for insomnia caseness as determined by self-report questionnaires. Participants completed outcome measures at 10 weeks (postintervention) and 18 weeks (follow-up) after randomization. All study visits were completed remotely, and the intervention was delivered digitally. Data were analyzed between December 12, 2018, and July 2, 2019.
Interventions


Digital CBT-I consisted of 6 weekly sessions of approximately 20 minutes each. Standard treatment reflected standard care. Women receiving standard treatment had no limits placed on the receipt of nonstudy treatments, including medication and psychotherapy.
Main Outcomes and Measures


All outcomes were assessed remotely using self-report questionnaires administered via online survey. The primary outcome was the change in insomnia symptom severity (measured by the Insomnia Severity Index) from baseline to postintervention. Secondary outcomes were sleep efficiency and nightly sleep duration (defined by sleep diary), global sleep quality (measured by the Pittsburgh Sleep Quality Index), depressive symptom severity (measured by the Edinburgh Postnatal Depression Scale), and anxiety symptom severity (measured by the Generalized Anxiety Disorder Scale-7). For each outcome, we also examined the change from baseline to follow-up.
Results


The 208 participants had a mean (SD) age of 33.6 (3.7) years and a mean (SD) gestational age of 17.6 (6.3) weeks at baseline. Most of the participants were white (138 [66.3%]), married or cohabiting (196 [94.2%]), had a college degree (180 [86.5%]), and earned $100 000 or more per year (141 [67.8%]). Women randomized to receive digital CBT-I experienced statistically significantly greater improvements in insomnia symptom severity from baseline to postintervention compared with women randomized to receive standard treatment (time-by-group interaction, difference = -0.36; 95% CI, -0.48 to -0.23; χ2 = 29.8; P < .001; d = -1.03). Improvements from baseline to postintervention for all secondary outcomes, with the exception of sleep duration, were statistically significant. A similar pattern of results was evident for the change from baseline to follow-up.
Conclusions and Relevance


In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy.
Trial Registration


ClinicalTrials.gov identifier: NCT02805998.",2020,"In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy.
","['pregnant women from November 23, 2016, to May 22, 2018', '208 participants had a mean (SD) age of 33.6 (3.7) years and a mean (SD) gestational age of 17.6 (6.3) weeks at baseline', 'participants were white (138 [66.3%]), married or cohabiting (196 [94.2%]), had a college degree (180 [86.5%]), and earned $100\u202f000 or more per year (141 [67.8', 'pregnant women with insomnia symptoms', ""Participants were pregnant up to 28 weeks' gestation, and they either had elevated insomnia symptom severity or met the criteria for insomnia caseness as determined by self-report questionnaires"", 'Pregnant Women', '2258 women assessed for eligibility using an online self-report questionnaire, 208 were randomized to receive']","['digital cognitive behavioral therapy', 'digital CBT-I (n\u2009=\u2009105) or standard treatment', 'Digital Cognitive Behavioral Therapy', 'digital']","['insomnia symptoms', 'change in insomnia symptom severity (measured by the Insomnia Severity Index', 'insomnia symptom severity', 'Insomnia Symptoms', 'sleep efficiency and nightly sleep duration (defined by sleep diary), global sleep quality (measured by the Pittsburgh Sleep Quality Index), depressive symptom severity (measured by the Edinburgh Postnatal Depression Scale), and anxiety symptom severity (measured by the Generalized Anxiety Disorder Scale-7', 'sleep duration']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0221179', 'cui_str': 'Cohabiting (finding)'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}]",,0.122935,"In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy.
","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Felder', 'Affiliation': 'Osher Center for Integrative Medicine, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco.'}, {'ForeName': 'Aric A', 'Initials': 'AA', 'LastName': 'Prather', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2019.4491']
3161,31135888,The effect of ticagrelor on growth of small abdominal aortic aneurysms-a randomized controlled trial.,"AIMS


To evaluate if ticagrelor, an effective platelet inhibitor without known non-responders, could inhibit growth of small abdominal aortic aneurysms (AAAs).
METHODS AND RESULTS


In this multi-centre randomized controlled trial, double-blinded for ticagrelor and placebo, acetylic salicylic acid naïve patients with AAA and with a maximum aortic diameter 35-49 mm were included. The primary outcome was mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months compared with baseline. Secondary outcomes include AAA-diameter growth rate and intraluminal thrombus (ILT) volume enlargement rate. A total of 144 patients from eight Swedish centres were randomized (72 in each group). MRI AAA volume increase was 9.1% for the ticagrelor group and 7.5% for the placebo group (P = 0.205) based on intention-to-treat analysis, and 8.5% vs. 7.4% in a per-protocol analysis (P = 0.372). MRI diameter change was 2.5 mm vs. 1.8 mm (P = 0.113), US diameter change 2.3 mm vs. 2.2 mm (P = 0.778), and ILT volume change 12.9% vs. 10.4% (P = 0.590).
CONCLUSION


In this RCT, platelet inhibition with ticagrelor did not reduce growth of small AAAs. Whether the ILT has an important pathophysiological role for AAA growth cannot be determined based on this study due to the observed lack of thrombus modulating effect of ticagrelor.
TRIAL REGISTRATION


The TicAAA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT02070653.",2020,"MRI diameter change was 2.5 mm vs 1.8 mm (p = 0.113), US diameter change 2.3 mm vs 2.2 mm (p = 0.778), and ILT volume change 12.9% vs 10.4% (p = 0.590).
","['naïve patients with AAA and with a maximum aortic diameter 35-49\u2009mm were included', '144 patients from eight Swedish centers']","['ticagrelor and placebo, acetylic salicylic acid', 'ILT', 'ticagrelor']","['MRI diameter change', 'ILT volume change', 'AAA-diameter growth rate and ILT volume enlargement rate', 'MRI AAA volume increase', 'mean reduction in log-transformed AAA volume growth rate (%) measured with magnetic resonance imaging (MRI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter (observable entity)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036080', 'cui_str': 'Salicylic Acids'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]",,0.709248,"MRI diameter change was 2.5 mm vs 1.8 mm (p = 0.113), US diameter change 2.3 mm vs 2.2 mm (p = 0.778), and ILT volume change 12.9% vs 10.4% (p = 0.590).
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wanhainen', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mani', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kullberg', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala SE-75185, Sweden.'}, {'ForeName': 'Sverker', 'Initials': 'S', 'LastName': 'Svensjö', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bersztel', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Karlsson', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Holst', 'Affiliation': 'Department of Vascular Diseases, Malmö University Hospital, Malmö SE-21421, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Gottsäter', 'Affiliation': 'Department of Vascular Diseases, Malmö University Hospital, Malmö SE-21421, Sweden.'}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Linné', 'Affiliation': 'Department of Surgery, Vascular Surgery and Department of Clinical Science and Education, Karolinska Institutet at Södersjukhuset, Stockholm SE-11883, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gillgren', 'Affiliation': 'Department of Surgery, Vascular Surgery and Department of Clinical Science and Education, Karolinska Institutet at Södersjukhuset, Stockholm SE-11883, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Langenskiöld', 'Affiliation': 'Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg SE-41345, Sweden.'}, {'ForeName': 'Rebecka', 'Initials': 'R', 'LastName': 'Hultgren', 'Affiliation': 'Department of Vascular Surgery, Karolinska University Hospital, Stockholm SE-17164, Sweden.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Roy', 'Affiliation': 'Department of Vascular Surgery, Karolinska University Hospital, Stockholm SE-17164, Sweden.'}, {'ForeName': 'Nils-Peter', 'Initials': 'NP', 'LastName': 'Gilgen', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ahlström', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala SE-75185, Sweden.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Lederle', 'Affiliation': 'Department of Medicine (III-0), Veterans Affairs Medical Center, One Veterans Drive, Minneapolis, Minnesota 55417, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Björck', 'Affiliation': 'Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala SE-751 85, Sweden.'}]",Cardiovascular research,['10.1093/cvr/cvz133']